id|nct_id|outcome_id|non_inferiority_type|non_inferiority_description|param_type|param_value|dispersion_type|dispersion_value|p_value_modifier|p_value|ci_n_sides|ci_percent|ci_lower_limit|ci_upper_limit|ci_upper_limit_na_comment|p_value_description|method|method_description|estimate_description|groups_description|other_analysis_description|ci_upper_limit_raw|ci_lower_limit_raw|p_value_raw
71090727|NCT05539131|141687849|SUPERIORITY|The LMM analysis results refer to the F-statistics and associated p-values derived from linear mixed-effects models (LMMs), including fixed effects for time, group, and their interaction.||||||0.862||||||This is p-valu regarding time and group.|Mixed Models Analysis|||||||0.862
71090728|NCT05539131|141687850|SUPERIORITY|The LMM analysis results refer to the F-statistics and associated p-values derived from linear mixed-effects models (LMMs), including fixed effects for time, group, and their interaction.||||||0.662||||||This is p-valu regarding time and group.|Mixed Models Analysis|||||||0.662
71090729|NCT05539131|141687851|SUPERIORITY|The LMM analysis results refer to the F-statistics and associated p-values derived from linear mixed-effects models (LMMs), including fixed effects for time, group, and their interaction.||||||0.318||||||This is p-valu regarding time and group.|ANOVA|||||||0.318
71090730|NCT05539131|141687852|SUPERIORITY|||||||0.273|||||||ANOVA|||||||0.273
71151461|NCT04953728|141795032|SUPERIORITY|||||||0.77306724|||||||t-test, 2 sided|||Change in maximum tolerance in mmHg of the rectum during ST36 100Hz when compared to baseline||||0.77306724
71151462|NCT04953728|141795032|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||Change in maximum tolerance in mmHg of the rectum during ST36 25Hz when compared to baseline||||0.24
71151463|NCT04953728|141795032|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||Change in maximum tolerance in mmHg of the rectum during PC6 100Hz when compared to baseline||||0.45
71151464|NCT04953728|141795032|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||Change in maximum tolerance in mmHg of the rectum during PC6 25Hz when compared to baseline||||0.13
71151465|NCT04953728|141795032|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||Change in maximum tolerance in mmHg of the rectum during Sham when compared to baseline||||0.14
71151466|NCT04953728|141795033|SUPERIORITY|||||||0.81019363|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 100Hz when compared to ST36 25Hz||||0.81019363
71151467|NCT04953728|141795033|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 100Hz when compared to PC6 100Hz||||0.18
71151468|NCT04953728|141795033|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 100Hz when compared to PC6 25Hz||||0.21
71151469|NCT04953728|141795033|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 100Hz when compared to Sham||||0.58
71151470|NCT04953728|141795033|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 25Hz when compared to PC6 100Hz||||0.18
71151471|NCT04953728|141795033|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 25Hz when compared to PC6 25Hz||||0.18
71090731|NCT05539131|141687853|SUPERIORITY|||||||0.639|||||||ANOVA|||||||0.639
71090732|NCT05539131|141687854|SUPERIORITY|||||||0.452|||||||ANOVA|||||||0.452
71090733|NCT00849056|141687877|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.75|||<|0.0001|TWO_SIDED|95.0|-0.95|-0.56|||ANCOVA|||||-0.56|-0.95|<0.0001
71151472|NCT04953728|141795033|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 25Hz when compared to sham||||0.78
71102620|NCT04875533|141713840|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.77|||||TWO_SIDED|95.0|0.65|0.91||||||Serotype 5: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.91|0.65|
71102621|NCT04875533|141713840|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.87|||||TWO_SIDED|95.0|0.73|1.05||||||Serotype 6A: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||1.05|0.73|
71151473|NCT04953728|141795033|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||Change in average maximum tolerance of PC6 100Hz when compared to PC6 25Hz||||0.89
71151474|NCT04953728|141795033|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||Change in average maximum tolerance of PC6 100Hz when compared to sham||||0.05
71151475|NCT04953728|141795033|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||Change in average maximum tolerance of PC6 25Hz when compared to sham||||0.07
71151476|NCT04953728|141795034|SUPERIORITY|||||||0.00046998|||||||t-test, 2 sided|||ST36 100Hz: Difference of VAS sums between 15 and 50 mmHg between pre and post stimulation||||0.00046998
71151477|NCT04953728|141795034|SUPERIORITY|||||||0.74369428|||||||t-test, 2 sided|||ST36 25Hz: Difference of VAS sums between 15 and 50 mmHg between pre and post stimulation||||0.74369428
71151478|NCT04953728|141795034|SUPERIORITY|||||||0.09854383|||||||t-test, 2 sided|||PC6 100Hz: Difference of VAS sums between 15 and 50 mmHg between pre and post stimulation||||0.09854383
71151479|NCT04953728|141795034|SUPERIORITY|||||||0.24872746|||||||t-test, 2 sided|||PC6 25Hz: Difference of VAS sums between 15 and 50 mmHg between pre and post stimulation||||0.24872746
71151480|NCT04953728|141795034|SUPERIORITY|||||||0.04828889|||||||t-test, 2 sided|||Sham: Difference of VAS sums between 15 and 50 mmHg between pre and post stimulation||||0.04828889
71151481|NCT04953728|141795035|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||ST36 100Hz compared to ST36 25Hz||||0.02
71151482|NCT04953728|141795035|SUPERIORITY|||||||0.11|||||||t-test, 1 sided|||ST36 100Hz compared to PC6 100Hz||||0.11
71151483|NCT04953728|141795035|SUPERIORITY|||||||0.01|||||||t-test, 1 sided|||ST36 100Hz compared to PC6 25Hz||||0.01
71151484|NCT04953728|141795035|SUPERIORITY|||||||0.04|||||||t-test, 1 sided|||ST36 100Hz compared to Sham||||0.04
71151485|NCT04953728|141795035|SUPERIORITY|||||||0.11|||||||t-test, 1 sided|||ST36 25Hz compared to PC6 100Hz||||0.11
71151486|NCT04953728|141795035|SUPERIORITY|||||||0.23|||||||t-test, 1 sided|||ST36 25Hz compared to PC6 25Hz||||0.23
71151487|NCT04953728|141795035|SUPERIORITY|||||||0.17|||||||t-test, 1 sided|||ST36 25Hz compared to Sham||||0.17
71151488|NCT04953728|141795035|SUPERIORITY|||||||0.15|||||||t-test, 1 sided|||PC6 100Hz compared to PC6 25Hz||||0.15
71151489|NCT04953728|141795035|SUPERIORITY|||||||0.43|||||||t-test, 1 sided|||PC6 100Hz compared to Sham||||0.43
71151490|NCT04953728|141795035|SUPERIORITY|||||||0.19|||||||t-test, 1 sided|||PC6 25Hz compared to Sham||||0.19
71151491|NCT04953728|141795036|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||Change in maximum volume in mL of the rectum during ST36 100Hz when compared to baseline||||0.87
71151492|NCT04953728|141795036|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||Change in maximum volume in mL of the rectum during ST36 25Hz when compared to baseline||||0.13
70906762|NCT00802737|141302998|SUPERIORITY_OR_OTHER||proportion of responders|0.24|||||TWO_SIDED|95.0|0.07|0.5|||||Two-sided 95% exact confidence intervals were calculated based on the binomial distribution. The estimated value was calculated using the number of responders (CR+nPR+PR) as the numerator and the total number of par. in the group as the denominator.|||0.50|0.07|
71090734|NCT03427892|141687885|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.|||||<|0.001||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||<.001
71090735|NCT03427892|141687886|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.93||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.93
71090736|NCT03427892|141687887|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.49||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor. The above reported is RAVLT Score|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.49
71090737|NCT03427892|141687887|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.56||||||Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.Reported is delay score|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.56
71090738|NCT03427892|141687888|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.221||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor. Reported is CW score.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.221
71151493|NCT04953728|141795036|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||Change in maximum volume in mL of the rectum during PC6 100Hz when compared to baseline||||0.17
70906763|NCT00802737|141302998|SUPERIORITY_OR_OTHER||proportion of responders|0.18|||||TWO_SIDED|95.0|0.02|0.52|||||Two-sided 95% exact confidence intervals were calculated based on the binomial distribution. The estimated value was calculated using the number of responders (CR+nPR+PR) as the numerator and the total number of par. in the group as the denominator.|||0.52|0.02|
70906764|NCT00802737|141302998|SUPERIORITY_OR_OTHER||proportion of responders|1.0|||||TWO_SIDED|95.0|0.03|1.0|||||Two-sided 95% exact confidence intervals were calculated based on the binomial distribution. The estimated value was calculated using the number of responders (CR+nPR+PR) as the numerator and the total number of par. in the group as the denominator.|||1.00|0.03|
70906765|NCT03677128|141303011|OTHER||Mean Difference (Final Values)|23.8|||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
70906766|NCT03677128|141303011|OTHER||Mean Difference (Final Values)|21.1|||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
71090739|NCT03427892|141687888|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.306||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.Reported is Inter. score|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.306
71090740|NCT03427892|141687889|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.07||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor. The above reported is TMT A.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.07
71090741|NCT03427892|141687889|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.19||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.The above reported is TMT B.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.19
71090742|NCT03427892|141687890|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.|||||<|0.001||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||<.001
71090743|NCT03427892|141687891|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.022||||||To analyze separate one-way repeated measures analyses of variance (ANOVA) were performed. Time (baseline, week 4, week 8) was included as the within-subject factor.Above is from baseline to week 8 for C-SSRS AA, IA, and ABA.|ANOVA|One-way repeated measures (ANOVA) were performed. Time (baseline, wk 4, wk 8) included as within-subject factor. Above is for C-SSRS AA,IA, and ABA.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.022
71090744|NCT03427892|141687891|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.163||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.163
71151494|NCT04953728|141795036|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||Change in maximum volume in mL of the rectum during PC6 25Hz when compared to baseline||||0.88
71151495|NCT04953728|141795036|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||Change in maximum volume in mL of the rectum during sham when compared to baseline||||0.14
71151496|NCT04953728|141795037|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||Change in first sensation in mmHg of the rectum during ST36 100Hz when compared to baseline||||0.007
70906767|NCT00445601|141303035|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.01|TWO_SIDED|95.0|0.48|0.9|||Log Rank|||||0.90|0.48|0.01
70906768|NCT00445601|141303036|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.23|TWO_SIDED|95.0|0.18|1.49|||Log Rank|||||1.49|0.18|0.23
71090745|NCT03427892|141687892|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.133||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.133
71090746|NCT03427892|141687893|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.002||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.002
71090747|NCT03427892|141687894|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.002||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.002
71090748|NCT03427892|141687895|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.005||||||Pairwise comparisons were also performed to determine which time points were significantly different from one another. Baseline to week 8 is reported above.|t-test, 2 sided|Pairwise comparisons were also performed to determine which time points were significantly different from one another.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.005
71090749|NCT03427892|141687896|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.|||||<|0.001||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||<.001
71090750|NCT03427892|141687897|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.295||||||Pairwise comparisons were also performed to determine which time points were significantly different from one another. Baseline to week 8 is reported above.|t-test, 2 sided|Pairwise comparisons were also performed to determine which time points were significantly different from one another.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.295
71151497|NCT04953728|141795037|SUPERIORITY|||||||0.83|||||||t-test, 2 sided|||Change in first sensation in mmHg of the rectum during ST36 25Hz when compared to baseline||||0.83
71151498|NCT04953728|141795037|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||Change in first sensation in mmHg of the rectum during PC6 100Hz when compared to baseline||||0.87
70925892|NCT03536754|141345467|SUPERIORITY||LSM Ratio|1.2|STANDARD_ERROR_OF_MEAN|1.136||0.1537|TWO_SIDED|90.0|0.97|1.48||≤ 0.1537|Mixed effects model for repeated measure|||||1.48|0.97|0.1537
70968422|NCT00346073|141442804|NON_INFERIORITY|The primary objective of non-inferiority was met if the lower limit of the 95% confidence intervals (CIs), between the two groups (Boostrix Group - Adacel Group) were greater than or equal to (≥) -10%|Difference in percentage|-0.43|||||TWO_SIDED|95.0|-1.47|0.84||||||The non-inferiority of Boostrix® vaccine compared to Adacel™ vaccine, with respect to the percentage of subjects with anti-diphtheria (anti-D) antibody concentrations greater than or equal to (≥) 0.1 IU/mL, one month after vaccination.||0.84|-1.47|
71151499|NCT04953728|141795037|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||Change in first sensation in mmHg of the rectum during PC6 25Hz when compared to baseline||||0.004
70906769|NCT00214903|141303039|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on a non-inferiority test to exclude a two-fold risk of cardiovascular events in users of DRSP/E2 compared to other oral continuous combined HRT. These calculations are based on the following assumptions: 1) one-sided α 0.05; 2) power (1-β) of 0.80; 3) Estimated incidence of cardiovascular events, ATE and VTE would be at least 1.0, 0.3 and 0.2 event/100 woman-years and 4) non-inferiority limit hazard ratio of 2.|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.5|1.3|||||Hazard ratio was adjusted for age, BMI, duration of current use, family history of VTE, region, and HRT user status.|Tested null hypotheses: the VTE hazard ratio for DRSP/E2 vs. ooccHRT is higher or equal to 2.||1.3|0.5|
70968423|NCT00346073|141442804|NON_INFERIORITY|The primary objective of non-inferiority was met if the lower limit of the 95% confidence intervals (CIs), between the two groups (Boostrix Group - Adacel Group) were greater than or equal to (≥) -10%|Difference in percentage|-0.42|||||TWO_SIDED|95.0|-0.9|0.11||||||The non-inferiority of Boostrix® vaccine compared to Adacel™ vaccine, with respect to the percentage of subjects with anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) 0.1 IU/mL, one month after vaccination.||0.11|-0.9|
71151500|NCT04953728|141795037|SUPERIORITY|||||||0.056|||||||t-test, 2 sided|||Change in first sensation in mmHg of the rectum during sham when compared to baseline||||0.056
71151501|NCT01136980|141795038|SUPERIORITY||||||<|0.028|||||||Chi-squared|||||||<0.028
71151502|NCT00990704|141795056|SUPERIORITY_OR_OTHER||Difference between arms in percentage|13.6||||0.518|TWO_SIDED|95.0|-22.36|49.63|||Fisher Exact|||||49.63|-22.36|0.518
71151503|NCT01106690|141795104|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.095|<|0.001|TWO_SIDED|95.0|-0.811|-0.437|||ANCOVA|||||-0.437|-0.811|<0.001
71151504|NCT01106690|141795104|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.096|<|0.001|TWO_SIDED|95.0|-0.951|-0.575|||ANCOVA|||||-0.575|-0.951|<0.001
71151505|NCT01106690|141795105|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4||||0.007||95.0|1.26|4.57|||Regression, Logistic|||||4.57|1.26|0.007
71151506|NCT01106690|141795105|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.38|||<|0.001|TWO_SIDED|95.0|2.73|10.6|||Regression, Logistic|||||10.60|2.73|<0.001
71151507|NCT01106690|141795106|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-29.4|STANDARD_ERROR_OF_MEAN|3.857|<|0.001|TWO_SIDED|95.0|-36.96|-21.78|||ANCOVA|||||-21.78|-36.96|<0.001
71151508|NCT01106690|141795106|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-35.7|STANDARD_ERROR_OF_MEAN|3.861|<|0.001|TWO_SIDED|95.0|-43.3|-28.11|||ANCOVA|||||-28.11|-43.30|<0.001
71151509|NCT01106690|141795107|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|14.28|STANDARD_ERROR_OF_MEAN|2.521|<|0.001|TWO_SIDED|95.0|9.315|19.236|||ANCOVA|||||19.236|9.315|<0.001
71151510|NCT01106690|141795107|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|17.23|STANDARD_ERROR_OF_MEAN|2.509|<|0.001|TWO_SIDED|95.0|12.293|22.166|||ANCOVA|||||22.166|12.293|<0.001
71151511|NCT01106690|141795108|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.6|-1.8|||ANCOVA|||||-1.8|-3.6|<0.001
71151512|NCT01106690|141795108|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-4.6|-2.8|||ANCOVA|||||-2.8|-4.6|<0.001
71151513|NCT01106690|141795109|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-4.07|STANDARD_ERROR_OF_MEAN|1.43||0.005|TWO_SIDED|95.0|-6.879|-1.251|||ANCOVA|||||-1.251|-6.879|0.005
71151514|NCT01106690|141795109|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.46|STANDARD_ERROR_OF_MEAN|1.433||0.016|TWO_SIDED|95.0|-6.281|-0.643|||ANCOVA|||||-0.643|-6.281|0.016
71151515|NCT01106690|141795110|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-12.1|STANDARD_ERROR_OF_MEAN|5.7||0.034|TWO_SIDED|95.0|-12.1|-0.9|||ANCOVA|||||-0.9|-12.1|0.034
71151516|NCT01106690|141795110|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-16.9|STANDARD_ERROR_OF_MEAN|5.7||0.003|TWO_SIDED|95.0|-28.1|-5.8|||ANCOVA|||||-5.8|-28.1|0.003
71151517|NCT01106690|141795111|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|4.8|STANDARD_ERROR_OF_MEAN|1.9||0.01|TWO_SIDED|95.0|1.2|8.5|||ANCOVA|||||8.5|1.2|0.010
71151518|NCT01106690|141795111|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|6.5|STANDARD_ERROR_OF_MEAN|1.9|<|0.001|TWO_SIDED|95.0|2.8|10.2|||ANCOVA|||||10.2|2.8|<0.001
71151519|NCT02863419|141795112|NON_INFERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand). A value of 0.4% (the non-inferiority margin) was added to imputed values at week 26 for the oral semaglutide treatment arm only.|Mean treatment difference|-0.1|||<|0.0001|TWO_SIDED|95.0|-0.3|0.0||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin. The non-inferiority margin was 0.4%|Pattern mixture model||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.0|-0.3|<0.0001
71151520|NCT02863419|141795112|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.1||||0.0645|TWO_SIDED|95.0|-0.3|0.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.0|-0.3|0.0645
71151521|NCT02863419|141795112|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.9||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.9|-1.2|<0.0001
71151522|NCT02863419|141795112|NON_INFERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.2|||<|0.0001|TWO_SIDED|95.0|-0.3|-0.1||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.4%.|MMRM||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.1|-0.3|<0.0001
71151523|NCT02863419|141795112|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.2||||0.0056|TWO_SIDED|95.0|-0.3|-0.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.1|-0.3|0.0056
71151524|NCT02863419|141795112|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-1.2||||0.0001|TWO_SIDED|95.0|-1.4|-1.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.0|-1.4|0.0001
71151525|NCT02863419|141795113|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-1.2||||0.0003|TWO_SIDED|95.0|-1.9|-0.6||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.6|-1.9|0.0003
71151526|NCT02863419|141795113|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-3.8|||<|0.0001|TWO_SIDED|95.0|-4.7|-3.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-3.0|-4.7|<0.0001
71090751|NCT00362232|141687904|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-2.71|||<|0.001||95.0|-5.25|-0.17|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence of the primary efficacy endpoint in the rivaroxaban group is larger by more than 4% (absolute) compared to the comparator group.||-0.17|-5.25|<0.001
71029521|NCT00090857|141567095|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Sample size for a detectable difference in the within participant change in bone density between arms was calculated using standard deviations of one year change in bone density. Control estimates were 2.8% for spine and 3.85% for femoral neck. With 100 patients and 2:1 randomization (67 letrozole: 33 placebo), using a 1-sided Wilcoxon rank sum test with size 0.05, there is 80% power to detect as significant a true difference in change in the spine of 1.6% and in the femoral neck of 2.27%.||||0.15
71090752|NCT00362232|141687904|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.71||||0.036||95.0|-5.25|-0.17|||Mantel Haenszel|weighted treatment differences||Null hypothesis: The incidence of the primary efficacy endpoint is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided).||-0.17|-5.25|0.036
71008699|NCT02055976|141525243|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.301|STANDARD_ERROR_OF_MEAN|1.832||0.011|TWO_SIDED|95.0|0.658|7.943|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.943|0.658|0.011
71090753|NCT00362232|141687905|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.19||||0.012||95.0|-5.67|-0.71|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence of the primary efficacy endpoint is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided).||-0.71|-5.67|0.012
71090754|NCT00362232|141687906|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.37||||0.456||95.0|-1.34|0.6|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence of the major VTE is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||0.6|-1.34|0.456
71090755|NCT00362232|141687906|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-0.37|||<|0.001||95.0|-1.34|0.6|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence of the major VTE in the rivaroxaban group is larger by more than 1.5% (absolute) compared to the comparator group.||0.6|-1.34|<0.001
71090756|NCT00362232|141687907|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.8||||0.124||95.0|-1.82|0.22|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence of the major VTE is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||0.22|-1.82|0.124
71090757|NCT00362232|141687907|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-0.8|||<|0.001||95.0|-1.82|0.22|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence of the major VTE in the rivaroxaban group is larger by more than 1.5% (absolute) compared to the comparator group.||0.22|-1.82|<0.001
71090758|NCT00362232|141687908|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.44||||||95.0|-1.59|0.66|||||Mantel-Haenszel weighted difference to Enoxaparin|||0.66|-1.59|
71090759|NCT00362232|141687909|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.72||||||95.0|-1.81|0.36|||||Mantel-Haenszel weighted difference to Enoxaparin|||0.36|-1.81|
71090760|NCT00362232|141687910|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.38||||||95.0|-4.84|0.07|||||Mantel-Haenszel weighted difference to Enoxaparin|||0.07|-4.84|
71090761|NCT00362232|141687911|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.67||||||95.0|-5.02|-0.32|||||Mantel-Haenszel weighted difference to Enoxaparin|||-0.32|-5.02|
71090762|NCT00362232|141687912|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.24||||||95.0|-0.22|0.71|||||Mantel-Haenszel weighted difference to Enoxaparin|||0.71|-0.22|
71090763|NCT00362232|141687913|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.11||||||95.0|-0.35|0.56||||||||0.56|-0.35|
71090764|NCT00362232|141687914|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.3||||||95.0|-1.56|0.94|||||Exact methods for difference to Enoxaparin|||0.94|-1.56|
71090765|NCT00362232|141687915|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.47||||0.054||95.0|-4.99|0.04|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||0.04|-4.99|0.054
71090766|NCT00362232|141687915|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-2.47|||<|0.001||95.0|-4.49|0.04|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence rate in the rivaroxaban group is larger by more than 4% (absolute) compared to the comparator group.||0.04|-4.49|<0.001
71090767|NCT00362232|141687916|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.97||||0.017||95.0|-5.42|-0.53|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||-0.53|-5.42|0.017
71090768|NCT00362232|141687916|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-2.97|||<|0.001||95.0|-5.42|-0.53|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence rate in the rivaroxaban group is larger by more than 4% (absolute) compared to the comparator group.||-0.53|-5.42|<0.001
71090769|NCT00362232|141687917|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.57||||0.27||95.0|-1.57|0.44|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||0.44|-1.57|0.270
71090770|NCT00362232|141687917|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-0.57|||<|0.001||95.0|-1.57|0.44|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence rate in the rivaroxaban group is larger by more than 1.5% (absolute) compared to the comparator group.||0.44|-1.57|<0.001
71090771|NCT00362232|141687918|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.98||||0.074||95.0|-2.06|0.1|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||0.10|-2.06|0.074
71151527|NCT02863419|141795113|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-1.5|||<|0.0001|TWO_SIDED|95.0|-2.2|-0.9||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.9|-2.2|<0.0001
71151528|NCT02863419|141795113|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-4.0|||<|0.0001|TWO_SIDED|95.0|-4.8|-3.2||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral sema 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-3.2|-4.8|<0.0001
71151529|NCT02863419|141795134|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.17||||0.4915|TWO_SIDED|95.0|0.75|1.8||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Liraglutide 1.8 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.80|0.75|0.4915
71151530|NCT02863419|141795134|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.32|||<|0.0001|TWO_SIDED|95.0|0.21|0.48||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.48|0.21|<0.0001
71151531|NCT02863419|141795135|SUPERIORITY|This hypothesis was not controlled for multiplicity|Hazard Ratio (HR)|1.17||||0.6252|TWO_SIDED|95.0|0.62|2.22||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Liraglutide 1.8 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||2.22|0.62|0.6252
71151532|NCT02863419|141795135|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.15|||<|0.0001|TWO_SIDED|95.0|0.09|0.26||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.26|0.09|<0.0001
71151533|NCT00473382|141795208|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|20.8|||<|0.0001|TWO_SIDED|95.0|11.4|30.2||An adjustment was made for multiple treatment comparisons of the ranibizumab dose groups with the control group.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||30.2|11.4|<0.0001
71151534|NCT00473382|141795208|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|33.3|||<|0.0001|TWO_SIDED|95.0|23.8|42.8||An adjustment was made for multiple treatment comparisons of the ranibizumab dose groups with the control group.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||42.8|23.8|<0.0001
70906770|NCT00214903|141303040|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on a non-inferiority test to exclude a two-fold risk of cardiovascular events in users of DRSP/E2 compared to other oral continuous combined HRT. These calculations are based on the following assumptions: 1) one-sided α 0.05; 2) power (1-β) of 0.80; 3) Estimated incidence of cardiovascular events, ATE and VTE would be at least 1.0, 0.3 and 0.2 event/100 woman-years and 4) non-inferiority limit hazard ratio of 2.|Hazard Ratio (HR)|0.5|||||TWO_SIDED|95.0|0.3|0.8|||||Hazard ratio was adjusted for age, BMI, hypertension, diabetes, family history of fatal ATE, region, and smoking.|Tested null hypotheses: the ATE hazard ratio for DRSP/E2 vs. ooccHRT is higher or equal to 2.||0.8|0.3|
70968424|NCT00346073|141442805|NON_INFERIORITY|The primary objective of non-inferiority was met if the lower limit of the 95% confidence intervals (CIs), between the two groups (Boostrix Group - Adacel Group) were greater than or equal to (≥) -10%|Difference in percentage|-1.04|||||TWO_SIDED|95.0|-1.97|0.0||||||The non-inferiority of Boostrix® vaccine compared to Adacel™ vaccine, with respect to the percentage of subjects with anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) 1.0 IU/mL, one month after vaccination.||0|-1.97|
71151535|NCT00473382|141795209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.5|||<|0.0001|TWO_SIDED|95.0|5.4|11.5||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||11.5|5.4|<0.0001
70906771|NCT01625910|141303043|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.1|0.21||||||Baseline data by group assignment status (intervention or control) using means of the calculated BMI z-scores (U.S. CDC-2000 growth charts) implemented by applying the published LMS (shape, median, and scale) age- and sex/gender-specific parameters. Because of random assignment of a reasonably large number of children, an unadjusted analysis of change in outcomes between intervention and control groups is presented as well as the covariate-adjusted analysis of differences in changes.||0.21|-0.10|
71090772|NCT00362232|141687918|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided) .|Risk Difference (RD)|-0.98|||<|0.001||95.0|-2.06|0.1|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence rate in the rivaroxaban group is larger by more than 1.5% (absolute) compared to the comparator group.||0.10|-2.06|<0.001
71090773|NCT00362232|141687919|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.39||||0.11||95.0|-0.09|0.88|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||0.88|-0.09|0.110
71090774|NCT00274456|141687920|SUPERIORITY_OR_OTHER_LEGACY|||||||0.224||95.0||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons were performed only if this test was significant."|Cochran-Mantel-Haenszel|CMH test was stratified by study site||Independent reader assessed ORR. As per the protocol, if the conclusions from the investigator and independent assessments of response rate were the same, the investigator assessment was considered the primary analysis of response rate. If the conclusions were different, the independent radiology reader assessment was considered the primary analysis of response rate. The conclusions were different.||||0.224
71090775|NCT00274456|141687920|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons were performed only if this test was significant."|Cochran-Mantel-Haenszel|CMH was stratified by study site||Investigator assessed ORR. As per the protocol, if the conclusions from the investigator and independent assessments of response rate were the same, the investigator assessment was considered the primary analysis of response rate. If the conclusions were different, the independent radiology reader assessment was considered the primary analysis of response rate. The conclusions were different.||||<0.001
71090776|NCT00274456|141687920|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site||Investigator assessed ORR||||0.002
71090777|NCT00274456|141687920|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed ORR||||<0.001
71090778|NCT00274456|141687920|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site||Investigator assessed ORR||||>0.05
71090779|NCT00274456|141687920|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed ORR||||0.024
71090780|NCT00274456|141687920|SUPERIORITY_OR_OTHER_LEGACY|||||||0.099||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed ORR||||0.099
71090781|NCT00274456|141687920|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed ORR||||0.002
71090782|NCT00274456|141687921|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||0.027
71090783|NCT00274456|141687921|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||0.009
71090784|NCT00274456|141687921|SUPERIORITY_OR_OTHER_LEGACY|||||||0.017|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||0.017
71090785|NCT00274456|141687921|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||>0.05
71090786|NCT00274456|141687921|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||>0.05
71090787|NCT00274456|141687921|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||>0.05
71090788|NCT00274456|141687921|SUPERIORITY_OR_OTHER_LEGACY|||||||0.085|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||0.085
71090789|NCT00274456|141687921|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparison was performed only if this test was significant."|Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed disease control rate (DCR), ie, SD \>= 16 weeks, or CR or PR||||0.007
71090790|NCT00274456|141687921|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR||||>0.05
71151536|NCT00473382|141795209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.9|||<|0.0001|TWO_SIDED|95.0|6.4|13.3||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||13.3|6.4|<0.0001
71151537|NCT00473382|141795210|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|21.4||||0.0002|TWO_SIDED|95.0|10.8|31.9||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||31.9|10.8|0.0002
71151538|NCT00473382|141795210|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|27.1|||<|0.0001|TWO_SIDED|95.0|16.4|37.9||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||37.9|16.4|<0.0001
71151539|NCT00473382|141795211|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|7.1||||0.0119|TWO_SIDED|95.0|1.7|12.6||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||12.6|1.7|0.0119
71151540|NCT00473382|141795211|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|4.5||||0.1384|TWO_SIDED|95.0|-1.2|10.1||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||10.1|-1.2|0.1384
71151541|NCT00473382|141795212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.3||||0.0102|TWO_SIDED|95.0|2.0|14.6||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||14.6|2.0|0.0102
71090791|NCT00274456|141687921|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR||||0.009
70906772|NCT01625910|141303044|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.74|0.4||||||unadjusted net difference between groups||0.40|-0.74|
71090792|NCT00274456|141687921|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR||||0.005
71151542|NCT00473382|141795212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.2||||0.0005|TWO_SIDED|95.0|5.1|17.3||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||17.3|5.1|0.0005
71151543|NCT00473382|141795213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-111.8|||<|0.0001|TWO_SIDED|95.0|-151.6|-72.0||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANCOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||-72.0|-151.6|<0.0001
71151544|NCT00473382|141795213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-132.2|||<|0.0001|TWO_SIDED|95.0|-169.7|-94.8||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANCOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||-94.8|-169.7|<0.0001
71151545|NCT00473382|141795214|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|-4.3||||0.0853|TWO_SIDED|95.0|-9.3|0.8||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||0.8|-9.3|0.0853
71151546|NCT00473382|141795214|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|-5.8||||0.0073|TWO_SIDED|95.0|-9.8|-1.7||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||-1.7|-9.8|0.0073
71151547|NCT00473382|141795215|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|14.0||||0.0002|TWO_SIDED|95.0|6.8|21.1||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||21.1|6.8|0.0002
71151548|NCT00473382|141795215|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|28.3|||<|0.0001|TWO_SIDED|95.0|20.2|36.4||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||36.4|20.2|<0.0001
71090793|NCT00274456|141687921|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR||||>0.05
71090794|NCT00274456|141687921|SUPERIORITY_OR_OTHER_LEGACY|||||||0.098||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR||||0.098
71090795|NCT00274456|141687921|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR||||0.014
71151549|NCT00473382|141795216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||-0.5|-1.3|<0.0001
71151550|NCT00473382|141795216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||-1.0|-1.6|<0.0001
70906773|NCT02959138|141303045|OTHER|The test-to-reference ratio (geometric least squares mean (GLSM) ratio) and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|111.68|||||TWO_SIDED|90.0|86.94|143.47||||||The Estimate statement was used to produce the point estimate and the corresponding 90% confidence interval of the difference in PK parameters of interest on a logarithmic scale.||143.47|86.94|
70906774|NCT02959138|141303045|OTHER|The test-to-reference ratio GLSM ratio and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|107.04|||||TWO_SIDED|90.0|78.47|146.02||||||The Estimate statement was used to produce the point estimate and the corresponding 90% CI of the difference in PK parameters of interest on a logarithmic scale.||146.02|78.47|
70906775|NCT02959138|141303046|OTHER|The test-to-reference ratio GLSM ratio and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|111.92|||||TWO_SIDED|90.0|86.92|144.12||||||The Estimate statement was used to produce the point estimate and the corresponding 90% CI of the difference in PK parameters of interest on a logarithmic scale.||144.12|86.92|
71151551|NCT01189032|141795221|SUPERIORITY_OR_OTHER|||||||0.004||||||It's the p-value of linear trend. It's adjusted for multiplicity.|maximum contrast method|To confirm dose-response relation, two contrasts were provided; linear trend (-1, 0, 1), and saturated at 1% DE-089 ophthalmic solution (-2, 1, 1).||||||0.004
71151552|NCT01189032|141795221|SUPERIORITY_OR_OTHER|||||||0.006||||||It's the p-value of Saturated at 1% DE-089. It's adjusted for multiplicity.|maximum contrast method|To confirm dose-response relation, two contrasts were provided; linear trend (-1, 0, 1), and saturated at 1% DE-089 ophthalmic solution (-2, 1, 1).||||||0.006
71151553|NCT01166282|141795230|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-51.17|||=|0.039|TWO_SIDED|95.0|-99.69|-2.66|||ANCOVA|||||-2.66|-99.69|=0.039
71151554|NCT01166282|141795231|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.62|||=|0.382|TWO_SIDED|95.0|-5.32|2.08|||1-way ANOVA|||||2.08|-5.32|=0.382
71151555|NCT01166282|141795232|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4|||=|0.209|TWO_SIDED|95.0|-8.78|1.97|||1-way ANOVA|||||1.97|-8.78|=0.209
71151556|NCT01166282|141795233|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.12|||=|0.509|TWO_SIDED|95.0|-4.49|2.26|||1-way ANOVA|||||2.26|-4.49|=0.509
71151557|NCT01166282|141795234|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|||=|0.514|TWO_SIDED|95.0|-18.5|40.5|||Fisher Exact|||||40.5|-18.5|=0.514
71151558|NCT01166282|141795235|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|27.7|||=|0.111|TWO_SIDED|95.0|-2.0|57.5|||Fisher Exact|||||57.5|-2.0|=0.111
71151559|NCT01166282|141795236|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|34.8|||=|0.031|TWO_SIDED|95.0|8.1|61.6|||Fisher Exact|||||61.6|8.1|=0.031
71151560|NCT01995838|141795241|SUPERIORITY||LS Mean Difference|0.51||||0.0651|TWO_SIDED|95.0|-0.03|1.06|||ANCOVA|Baseline value and treatment as covariates.||||1.06|-0.03|0.0651
71151561|NCT01995838|141795241|SUPERIORITY||LS Mean Difference|0.13||||0.649|TWO_SIDED|95.0|-0.44|0.7|||ANCOVA|Baseline value and treatment as covariates.||||0.70|-0.44|0.6490
71151562|NCT01995838|141795241|SUPERIORITY||LS Mean Difference|0.43||||0.1059|TWO_SIDED|95.0|-0.09|0.94|||ANCOVA|Baseline value and treatment as covariates.||||0.94|-0.09|0.1059
71151563|NCT01995838|141795241|SUPERIORITY||LS Mean Difference|0.01||||0.9818|TWO_SIDED|95.0||0.55|||ANCOVA|Baseline value and treatment as covariates.||||0.55|-0. 54|0. 9818
71151564|NCT01995838|141795241|SUPERIORITY||LS Mean Difference|0.38||||0.1071|TWO_SIDED|95.0|-0.08|0.85|||ANCOVA|Baseline value and treatment as covariates.||||0.85|-0.08|0. 1071
71151565|NCT01995838|141795241|SUPERIORITY||LS Mean Difference|0.68||||0.0063|TWO_SIDED|95.0|0.19|1.17|||ANCOVA|Baseline value and treatment as covariates.||||1.17|0.19|0.0063
71151566|NCT01995838|141795242|SUPERIORITY||LS Mean Difference|4.57||||0.0083|TWO_SIDED|95.0|1.19|7.94|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||7.94|1.19|0.0083
71151567|NCT01995838|141795242|SUPERIORITY||LS Mean Difference|4.44||||0.0151|TWO_SIDED|95.0|0.86|8.01|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||8.01|0.86|0.0151
71151568|NCT01995838|141795242|SUPERIORITY||LS Mean Difference|5.74||||0.0005|TWO_SIDED|95.0|2.54|8.93|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||8.93|2.54|0.0005
71151569|NCT01995838|141795242|SUPERIORITY||LS Mean Difference|8.09|||<|0.0001|TWO_SIDED|95.0|4.73|11.45|||ANCOVA|||Days 1-2||11.45|4.73|<0.0001
71151570|NCT01995838|141795242|SUPERIORITY||LS Mean Difference|10.06|||<|0.0001|TWO_SIDED|95.0|7.2|12.93|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||12.93|7.20|<0.0001
71151571|NCT01995838|141795242|SUPERIORITY||LS Mean Difference|10.13|||<|0.0001|TWO_SIDED|95.0|7.18|13.08|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||13.08|7.18|<0.0001
71151572|NCT01995838|141795242|SUPERIORITY||LS Mean Difference|0.34||||0.8505|TWO_SIDED|95.0|-3.22|3.9|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||3.90|-3.22|0.8505
71151573|NCT01995838|141795242|SUPERIORITY||LS Mean Difference|3.94||||0.038|TWO_SIDED|95.0|0.22|7.66|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||7.66|0.22|0.0380
71151574|NCT01995838|141795242|SUPERIORITY||LS Mean Difference|5.76||||0.0008|TWO_SIDED|95.0|2.4|9.12|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||9.12|2.40|0.0008
71151575|NCT01995838|141795242|SUPERIORITY||LS Mean Difference|7.78|||<|0.0001|TWO_SIDED|95.0|4.24|11.32|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||11.32|4.24|<0.0001
71151576|NCT01995838|141795242|SUPERIORITY||LS Mean Difference|7.89|||<|0.0001|TWO_SIDED|95.0|4.86|10.92|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||10.92|4.86|<0.0001
71151577|NCT01995838|141795242|SUPERIORITY||LS Mean Difference|8.87|||<|0.0001|TWO_SIDED|95.0|5.72|12.02|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||12.02|5.72|<0.0001
71151578|NCT01995838|141795243|SUPERIORITY||Geometric Mean Ratio|0.77||||0.1407|TWO_SIDED|95.0|0.54|1.09|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||1.09|0.54|0.1407
71151579|NCT01995838|141795243|SUPERIORITY|Days 1-2|Geometric Mean Ratio|0.55||||0.0018|TWO_SIDED|95.0|0.38|0.8|||ANCOVA|Baseline value and treatment as covariates.||||0.80|0.38|0.0018
71151580|NCT01995838|141795243|SUPERIORITY||Geometric Mean Ratio|0.6||||0.0025|TWO_SIDED|95.0|0.43|0.83|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||0.83|0.43|0.0025
71151581|NCT01995838|141795243|SUPERIORITY||Geometric Mean Ratio|0.54||||0.0006|TWO_SIDED|95.0|0.38|0.76|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||0.76|0.38|0.0006
70906776|NCT02959138|141303046|OTHER|The test-to-reference ratio GLSM ratio and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|107.69|||||TWO_SIDED|90.0|79.63|145.65||||||The Estimate statement was used to produce the point estimate and the corresponding 90% CI of the difference in PK parameters of interest on a logarithmic scale.||145.65|79.63|
70906777|NCT02959138|141303047|OTHER|The test-to-reference ratio GLSM ratio and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|102.0|||||TWO_SIDED|90.0|81.42|127.79||||||The Estimate statement was used to produce the point estimate and the corresponding 90% CI of the difference in PK parameters of interest on a logarithmic scale.||127.79|81.42|
70906778|NCT02959138|141303047|OTHER|The test-to-reference ratio GLSM ratio and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|87.8|||||TWO_SIDED|90.0|68.14|113.13||||||The Estimate statement was used to produce the point estimate and the corresponding 90% CI of the difference in PK parameters of interest on a logarithmic scale.||113.13|68.14|
70906779|NCT01946243|141303145|SUPERIORITY_OR_OTHER|||||||0.0029|TWO_SIDED||||||t-test, 2 sided|||Paired t-test to test whether the change is equal to zero or not.||||0.0029
71090796|NCT00274456|141687922|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0498||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons were performed only if this test was significant."|Log Rank|||Independent assessment||||0.0498
71151582|NCT01995838|141795243|SUPERIORITY||Geometric Mean Ratio|0.52|||<|0.0001|TWO_SIDED|95.0|0.38|0.7|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||0.70|0.38|<0.0001
71151583|NCT01995838|141795243|SUPERIORITY||Geometric Mean Ratio|0.39|||<|0.0001|TWO_SIDED|95.0|0.29|0.54|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2:||0.54|0.29|<0.0001
70906780|NCT01946243|141303146|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority demonstrated if the lower bound of the one-sided 97.5% confidence interval is greater than -3%.|Mean Difference (Net)|4.2|||||ONE_SIDED|97.5|2.7||||||Units: Percent Accuracy||||2.7|
70906781|NCT01946243|141303147|SUPERIORITY_OR_OTHER||lower bound of two-sided 95% CI|0.06|||||TWO_SIDED|95.0|0.018|0.112||||||Superiority demonstrated if lower bound of two-sided 95% confidence interval (CI) greater than 0, for the change in kappa statistic.||0.112|0.018|
71151584|NCT01995838|141795243|SUPERIORITY||Geometric Mean Ratio|0.73||||0.1158|TWO_SIDED|95.0|0.49|1.08|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||1.08|0.49|0.1158
71151585|NCT01995838|141795243|SUPERIORITY||Geometric Mean Ratio|0.49||||0.001|TWO_SIDED|95.0|0.33|0.75|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||0.75|0.33|0.0010
71151586|NCT01995838|141795243|SUPERIORITY||Geometric Mean Ratio|0.47|||<|0.0001|TWO_SIDED|95.0|0.32|0.69|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||0.69|0.32|<0.0001
70906782|NCT01946243|141303148|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority demonstrated if the lower bound of the one-sided 97.5% confidence interval is greater than -3%.|Mean Difference (Net)|2.3|||||ONE_SIDED|97.5|0.8||||||Units: Percent Accuracy||||0.8|
71090797|NCT00274456|141687922|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.607||||0.0524|||||||Log Rank|||Independent assessment||||0.0524
71090798|NCT00274456|141687922|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.495||||0.0065|||||||Log Rank|||Independent assessment||||0.0065
71151587|NCT01995838|141795243|SUPERIORITY||Geometric Mean Ratio|0.32|||<|0.0001|TWO_SIDED|95.0|0.21|0.47|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||0.47|0.21|<0.0001
71151588|NCT01995838|141795243|SUPERIORITY||Geometric Mean Ratio|0.41|||<|0.0001|TWO_SIDED|95.0|0.29|0.57|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||0.57|0.29|<0.0001
71151589|NCT01995838|141795243|SUPERIORITY||Geometric Mean Ratio|0.34|||<|0.0001|TWO_SIDED|95.0|0.24|0.48|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||0.48|0.24|<0.0001
71151590|NCT01995838|141795244|SUPERIORITY||LS Mean Difference|-11.08||||0.105|TWO_SIDED|95.0|-24.48|2.33|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||2.33|-24.48|0.1050
71151591|NCT01995838|141795244|SUPERIORITY||LS Mean Difference|-2.29||||0.7501|TWO_SIDED|95.0|-16.46|11.87|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||11.87|-16.46|0.7501
71151592|NCT01995838|141795244|SUPERIORITY||LS Mean Difference|-11.26||||0.0818|TWO_SIDED|95.0|-23.94|1.43|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||1.43|-23.94|0.0818
71151593|NCT01995838|141795244|SUPERIORITY||LS Mean Difference|-19.81||||0.0038|TWO_SIDED|95.0|-33.18|-6.43|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||-6.43|-33.18|0.0038
71151594|NCT01995838|141795244|SUPERIORITY||LS Mean Difference|-29.34|||<|0.0001|TWO_SIDED|95.0|-40.75|17.93|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||17.93|-40.75|<0.0001
71151595|NCT01995838|141795244|SUPERIORITY||LS Mean Difference|-25.84|||<|0.0001|TWO_SIDED|95.0|-37.59|-14.09|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||-14.09|-37.59|<0.0001
71151596|NCT01995838|141795244|SUPERIORITY||LS Mean Difference|0.4642||||0.4642|TWO_SIDED|95.0|-9.6|20.98|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||20.98|-9.60|0.4642
71151597|NCT01995838|141795244|SUPERIORITY|Baseline value and treatment as covariates.|LS Mean Difference|-2.31||||0.7754|TWO_SIDED|95.0|-18.27|13.64|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||13.64|-18.27|0.7754
71151598|NCT01995838|141795244|SUPERIORITY||LS Mean Difference|-10.69||||0.1461|TWO_SIDED|95.0|-25.14|3.75|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||3.75|-25.14|0.1461
71151599|NCT01995838|141795244|SUPERIORITY||LS Mean Difference|-14.73||||0.0581|TWO_SIDED|95.0|-29.97|0.51|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||0.51|-29.97|0.0581
71151600|NCT01995838|141795244|SUPERIORITY||LS Mean Difference|-20.8||||0.0019|TWO_SIDED|95.0|-33.86|-7.74|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||-7.74|-33.86|0.0019
71151601|NCT01995838|141795244|SUPERIORITY||LS Mean Difference|-21.52||||0.002|TWO_SIDED|95.0|-35.12|-7.91|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||-7.91|-35.12|0.0020
71151602|NCT01995838|141795248|SUPERIORITY||LS Mean Difference|-3.05||||0.1483|TWO_SIDED|95.0|-7.2|1.09|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17||1.09|-7.20|0.1483
71151603|NCT01995838|141795248|SUPERIORITY||LS Mean Difference|-0.64||||0.772|TWO_SIDED|95.0|-4.96|3.69|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17||3.69|-4.96|0.7720
71151604|NCT01995838|141795248|SUPERIORITY||LS Mean Difference|1.5||||0.4548|TWO_SIDED|95.0|-2.44|5.44|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17||5.44|-2.44|0.4548
71151605|NCT01995838|141795248|SUPERIORITY||LS Mean Difference|-2.39||||0.253|TWO_SIDED|95.0|-6.51|1.72|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17||1.72|-6.51|0.2530
71151606|NCT01995838|141795248|SUPERIORITY||LS Mean Difference|2.41||||0.1794|TWO_SIDED|95.0|-1.11|5.93|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17||5.93|-1.11|0.1794
71090799|NCT00274456|141687922|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Independent assessment||||>0.05
71151607|NCT01995838|141795248|SUPERIORITY||LS Mean Difference|0.94||||0.6148|TWO_SIDED|95.0|-2.74|4.63|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17||4.63|-2.74|0.6148
71151608|NCT03511937|141795297|SUPERIORITY||Mean Difference (Final Values)|-31.4||||0.02|TWO_SIDED|95.0|-57.9|-5.0||The a priori threshold for statistical significance was \< 0.05.|Two-part regression model with robust SE|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||-5.0|-57.9|0.02
71151609|NCT03511937|141795298|SUPERIORITY||Mean Difference (Final Values)|-69.4||||0.55|TWO_SIDED|95.0|-295.5|156.6||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||156.6|-295.5|0.55
71151610|NCT03511937|141795299|SUPERIORITY||Mean Difference (Final Values)|-13.0||||0.006|TWO_SIDED|95.0|-23.0|-4.0||The a priori threshold for statistical significance was \< 0.05.|Regression, Logistic|Analyses controlled for overweight/obesity status and Hispanic ethnicity, which were unbalanced between treatment arms.|Analyses used logistic regression to calculate mean difference in predicted probability of purchasing a sugar-sweetened beverage.|||-4|-23|0.006
71151611|NCT03511937|141795300|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.01|TWO_SIDED|95.0|-0.4|-0.1||The a priori threshold for statistical significance was \< 0.05.|Negative binomial regression|Analyses controlled for overweight/obesity status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||-0.1|-0.4|0.010
71151612|NCT03511937|141795301|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.403|TWO_SIDED|95.0|-0.2|0.5||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for obesity status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust standard errors.||||0.5|-0.2|0.403
71151613|NCT03511937|141795302|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.005|TWO_SIDED|95.0|0.1|0.8||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.8|0.1|0.005
71151614|NCT03511937|141795303|SUPERIORITY||Mean Difference (Final Values)|37.0|||<|0.001|TWO_SIDED|95.0|32.0|43.0||The a priori threshold for statistical significance was \< 0.05.|Regression, Logistic|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between treatment arms.|Analyses used logistic regression to calculate mean difference in predicted probability of purchasing a sugar-sweetened beverage.|||43|32|<0.001
71151615|NCT03511937|141795304|SUPERIORITY||Mean Difference (Final Values)|1.7|||<|0.001|TWO_SIDED|95.0|1.4|1.9||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||1.9|1.4|<0.001
71151616|NCT03511937|141795305|SUPERIORITY||Mean Difference (Final Values)|0.4|||<|0.001|TWO_SIDED|95.0|0.3|0.5||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.5|0.3|<0.001
71090800|NCT00274456|141687922|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Independent assessment||||>0.05
71090801|NCT00274456|141687922|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Independent assessment||||>0.05
71090802|NCT00274456|141687922|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Independent assessment||||>0.05
71151617|NCT03511937|141795306|SUPERIORITY||Mean Difference (Final Values)|1.1|||<|0.001|TWO_SIDED|95.0|0.9|1.3||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||1.3|0.9|<0.001
71151618|NCT03511937|141795307|SUPERIORITY||Mean Difference (Final Values)|0.9|||<|0.001|TWO_SIDED|95.0|0.7|1.1||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||1.1|0.7|<0.001
71151619|NCT03511937|141795308|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.055|TWO_SIDED|95.0|-0.001|0.13||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.13|-0.001|0.055
71151620|NCT03511937|141795309|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.258|TWO_SIDED|95.0|-0.27|0.07||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.07|-0.27|0.258
70906783|NCT01946243|141303149|SUPERIORITY_OR_OTHER||lower bound of two-sided 95% CI|0.07||||0.028|TWO_SIDED|95.0|0.007|0.125|||Monte Carlo test|||Superiority demonstrated if lower bound of two-sided 95% CI greater than 0, for the change in kappa statistic.||0.125|0.007|0.0280
70906784|NCT01946243|141303150|SUPERIORITY_OR_OTHER|||||||0.0025|TWO_SIDED||||||t-test, 2 sided|||Paired t-test to test whether the change is equal to zero or not.||||0.0025
71090803|NCT00274456|141687922|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons was performed only if this test was significant."|Log Rank|||Investigator assessment||||0.008
71151621|NCT03511937|141795310|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.416|TWO_SIDED|95.0|-0.3|0.13||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.13|-0.30|0.416
71151622|NCT03511937|141795311|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.609|TWO_SIDED|95.0|-0.14|0.24||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.24|-0.14|0.609
71151623|NCT03511937|141795312|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.002|TWO_SIDED|95.0|0.1|0.5||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.5|0.1|0.002
71151624|NCT03511937|141795313|SUPERIORITY||Mean Difference (Final Values)|2.1|||<|0.001|TWO_SIDED|95.0|1.8|2.3||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||2.3|1.8|<0.001
71151625|NCT03511937|141795314|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.311|TWO_SIDED|95.0|-0.23|0.07||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.07|-0.23|0.311
71151626|NCT03511937|141795315|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.253|TWO_SIDED|95.0|-0.3|0.08||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.08|-0.30|0.253
71151627|NCT03511937|141795316|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.658|TWO_SIDED|95.0|-0.22|0.14||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.14|-0.22|0.658
71090804|NCT00274456|141687922|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
71151628|NCT03511937|141795317|SUPERIORITY||Mean Difference (Final Values)|-49.5||||0.661|TWO_SIDED|95.0|-271.3|172.3||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||172.3|-271.3|0.661
71151629|NCT03511937|141795318|SUPERIORITY||Mean Difference (Final Values)|12.5||||0.082|TWO_SIDED|95.0|-1.6|26.6||The a priori threshold for statistical significance was \< 0.05.|Two-part regression model with robust SE|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||26.6|-1.6|0.082
71151630|NCT00541385|141795344|OTHER|"Analysis of the PCR-corrected ACPR response rate on Day 28 for the PA group. Null hypothesis: The PCR-corrected ACPR response rate on Day 28 for the PA group is ≤90%.~Was tested versus the alternative:~Alternative hypothesis: The PCR-corrected ACPR response rate on Day 28 for the PA group is \>90%."|||||<|0.0001||||||The threshold for significance was ≤0.025.|Exact binomial test|||||||<0.0001
71151631|NCT00541385|141795344|NON_INFERIORITY|The secondary efficacy analysis tested the non-inferiority of PA compared to the AL group with regard to the PCR-corrected ACPR response rate on Day 28 using a 2-sided 95% confidence interval (Newcombe Wilson score method without continuity correction) and a 10% non-inferiority margin for the EE population. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval for the difference in 28-day PCR-corrected ACPR was not lower than 10%.|ACPR percent difference|-1.2||||0.3728|TWO_SIDED|95.0|-3.6|2.1||If non-inferiority of PA was demonstrated, the p-value associated with a superiority test was calculated based on a 2-sided Chi-Square test. If the calculated p-value was \<0.05, then the superiority of PA over AL was statistically demonstrated.|Chi-squared|||"Null hypothesis: The PCR-corrected ACPR response rate on Day 28 for the PA group is inferior to the PCR-corrected ACPR response rate for the AL group.~Was tested versus the alternative:~Alternative hypothesis: The PCR-corrected ACPR response rate on Day 28 for the PA group is not inferior to the PCR-corrected ACPR response rate for the AL group."||2.1|-3.6|0.3728
70906785|NCT01189890|141303168|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.4%.|Difference in LS Means|0.19|||||TWO_SIDED|95.0|0.03|0.34|||ANCOVA|Controlled for treatment, estimated glomerular filtration rate (eGFR) stratum, age stratum, and baseline HbA1C.||||0.34|0.03|
70906786|NCT01189890|141303169|SUPERIORITY_OR_OTHER||Difference in Percent Incidence|-3.9||||0.009|TWO_SIDED|95.0|-7.5|-1.2|||Miettinen & Nurminen|Stratified by estimated glomerular filtration rate (eGFR) stratum and age stratum.||||-1.2|-7.5|0.009
71090805|NCT00274456|141687922|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
71090806|NCT00274456|141687922|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.568||||0.012|||||||Log Rank|||Investigator assessment||||0.012
70906787|NCT01189890|141303172|SUPERIORITY_OR_OTHER||Difference in LS Means|6.7|||||TWO_SIDED|95.0|0.7|12.7|||ANCOVA|Controlled for treatment, eGFR stratum, age stratum, and baseline FPG.||||12.7|0.7|
70906788|NCT01189890|141303173|SUPERIORITY_OR_OTHER||Relative Risk|0.7|||||TWO_SIDED|95.0|0.6|0.9|||Miettinen & Nurminen|Stratified by eGFR stratum and age stratum.||||0.9|0.6|
70906789|NCT01189890|141303174|SUPERIORITY_OR_OTHER||Relative Risk|0.4|||||TWO_SIDED|95.0|0.3|0.7|||Miettinen & Nurminen|Stratified by eGFR stratum and age stratum.||||0.7|0.3|
70906790|NCT01189890|141303175|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.011|TWO_SIDED|95.0|-1.3|-0.2|||ANCOVA|Controlled for treatment, eGFR stratum, age stratum, and baseline body weight.||||-0.2|-1.3|0.011
70906791|NCT01649596|141303183|SUPERIORITY_OR_OTHER||percent|10.0||||0.12|TWO_SIDED||||||Chi-squared|||||||0.12
70906792|NCT01649596|141303184|SUPERIORITY_OR_OTHER||percent|48.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided|A t-test for percents was used to compare the number of participants (%) from each group reporting satisfaction (somewhat and highly satisfied).||||||<0.05
71151632|NCT01499355|141795358|SUPERIORITY_OR_OTHER|||||||0.367||||||P-Value from Cox proportional hazard model, including the variable for treatment, adjusted for the covariates including region (Latin America, Asia, rest of world \[ROW\]) and renal response at Run-in Week 12 (partial and non-response).|Cox proportional hazard|||||||0.367
70906793|NCT02254421|141303185|SUPERIORITY||Treatment difference|-0.02||||0.94|TWO_SIDED|95.0|-0.62|0.57||P-value was calculated from the ANCOVA model including baseline values and stratification factors.|ANCOVA|||||0.57|-0.62|0.94
71090807|NCT00274456|141687922|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.972||||0.001|||||||Log Rank|||Investigator assessment||||0.001
71151633|NCT01499355|141795358|SUPERIORITY_OR_OTHER|||||||0.283||||||P-Value from Cox proportional hazard model, including the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).|Cox proportional hazard|||||||0.283
71151634|NCT01499355|141795359|SUPERIORITY_OR_OTHER|||||||0.0486||||||Model includes the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).|Cochran-Mantel-Haenszel|||||||0.0486
70906794|NCT02254421|141303186|SUPERIORITY|||||||0.84||||||P-value was calculated from the negative binomial model with stratification factors as covariates.|Negative binomial|||||||0.84
71151635|NCT01499355|141795359|SUPERIORITY_OR_OTHER|||||||0.0668||||||Model includes the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).|Cochran-Mantel-Haenszel|||||||0.0668
71151636|NCT01499355|141795360|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0628||||0.0456|TWO_SIDED|90.0|0.0081|0.4843||Model includes the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).|Regression, Logistic|||||0.4843|0.0081|0.0456
70906795|NCT02254421|141303187|SUPERIORITY|||||||0.98||||||P-value was calculated from the Cochran-Mantel-Haenszel (CMH) test stratified by stratification factors.|Cochran-Mantel-Haenszel|||||||0.98
70906796|NCT02254421|141303188|SUPERIORITY|||||||0.19||||||P-value was calculated from the CMH test stratified by stratification factors.|Cochran-Mantel-Haenszel|||||||0.19
70906797|NCT03354637|141303274|SUPERIORITY||Mean Difference (Final Values)|13.88|STANDARD_ERROR_OF_MEAN|4.707||0.038|TWO_SIDED|95.0|0.77|27.0||All statistical testing was two-sided and performed using a significance (alpha) level of 0.05.|Mixed Models Analysis|||Since this was the first multicenter study evaluating the effect of ATI-50002 Topical Solution in subjects with stable patchy alopecia areata, the sample size was based upon feasibility issues rather than a formal power calculation. Planned data from 120 subjects, utilizing LOCF for missing data, provides 80% power to detect a 24-point difference in percent change from baseline in SALT score between any two treatment groups. This power computation is based upon assumed standard deviation of 38%.||27.00|0.77|0.038
71151637|NCT01499355|141795360|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4344||||0.5455|TWO_SIDED|90.0|0.0996|1.8941||Model includes the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).|Regression, Logistic|||||1.8941|0.0996|0.5455
71151638|NCT01499355|141795360|SUPERIORITY_OR_OTHER|||||||0.0252|||||||Cochran-Mantel-Haenszel|||||||0.0252
71151639|NCT01499355|141795360|SUPERIORITY_OR_OTHER|||||||0.2876|||||||Cochran-Mantel-Haenszel|||||||0.2876
71151640|NCT01499355|141795363|SUPERIORITY_OR_OTHER|||||||0.863|||||||Regression, Cox|||||||0.863
70906798|NCT03354637|141303274|SUPERIORITY||Mean Difference (Final Values)|9.32|STANDARD_ERROR_OF_MEAN|4.784||0.166|TWO_SIDED|95.0|-3.9|22.55||All statistical testing was two-sided and performed using a significance (alpha) level of 0.05.|Mixed Models Analysis|||Since this was the first multicenter study evaluating the effect of ATI-50002 Topical Solution in subjects with stable patchy alopecia areata, the sample size was based upon feasibility issues rather than a formal power calculation. Planned data from 120 subjects, utilizing LOCF for missing data, provides 80% power to detect a 24-point difference in percent change from baseline in SALT score between any two treatment groups. This power computation is based upon assumed standard deviation of 38%.||22.55|-3.90|0.166
70906799|NCT03354637|141303275|SUPERIORITY||Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|4.511||0.302|TWO_SIDED|95.0|-5.97|19.17|||Mixed Models Analysis|||||19.17|-5.97|0.302
70906800|NCT03354637|141303275|SUPERIORITY||Mean Difference (Final Values)|3.23|STANDARD_ERROR_OF_MEAN|4.584||0.616|TWO_SIDED|95.0|-9.44|15.9|||Mixed Models Analysis|||||15.90|-9.44|0.616
70906801|NCT03354637|141303276|SUPERIORITY||Mean Difference (Final Values)|4.52|STANDARD_ERROR_OF_MEAN|2.074||0.125|TWO_SIDED|95.0|-1.26|10.3|||Mixed Models Analysis|||||10.30|-1.26|0.125
71090808|NCT00274456|141687922|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.702||||0.076|||||||Log Rank|||Investigator assessment||||0.076
71090809|NCT00274456|141687922|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
71151641|NCT01499355|141795363|SUPERIORITY_OR_OTHER|||||||0.769|||||||Regression, Cox|||||||0.769
71151642|NCT01499355|141795363|SUPERIORITY_OR_OTHER|||||||0.907|||||||ANCOVA|||||||0.907
71151643|NCT01499355|141795363|SUPERIORITY_OR_OTHER|||||||0.996|||||||ANCOVA|||||||0.996
71151644|NCT01526733|141795364|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|2.15|||<|0.0001|TWO_SIDED|90.0|1.71|2.71||Comparison of Day 1 Insulin (Aspart or Lispro)-rHuPH20 versus Day 1 Insulin-sham.|Mixed Models Analysis|A mixed model with fixed effects for treatment, day, and interaction of treatment with day was performed using a compound symmetric covariance matrix.||||2.71|1.71|<0.0001
70906802|NCT03354637|141303276|SUPERIORITY||Mean Difference (Final Values)|3.53|STANDARD_ERROR_OF_MEAN|2.107||0.234|TWO_SIDED|95.0|-2.3|9.36|||Mixed Models Analysis|||||9.36|-2.30|0.234
70906803|NCT03354637|141303277|SUPERIORITY||Mean Difference (Final Values)|1.55|STANDARD_ERROR_OF_MEAN|2.131||0.607|TWO_SIDED|95.0|-4.39|7.49|||Mixed Models Analysis|||||7.49|-4.39|0.607
70906804|NCT03354637|141303277|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|2.165||0.981|TWO_SIDED|95.0|-6.06|5.92|||Mixed Models Analysis|||||5.92|-6.06|0.981
70906805|NCT03354637|141303278|SUPERIORITY||Odds Ratio (OR)|1.4||||0.62|TWO_SIDED|95.0|0.4|4.6|||Mixed Models Analysis|||||4.6|0.4|0.620
70906806|NCT03354637|141303278|SUPERIORITY||Odds Ratio (OR)|1.7||||0.366|TWO_SIDED|95.0|0.5|5.8|||Mixed Models Analysis|||||5.8|0.5|0.366
71090810|NCT00274456|141687923|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons was performed only if this test was significant."|Log Rank|||Independent assessment||||>0.05
71151645|NCT01526733|141795364|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|2.62|||<|0.0001|TWO_SIDED|90.0|2.08|3.29||Comparison of Day 4 Insulin (Aspart or Lispro)-rHuPH20 versus Day 1 Insulin-sham.|Mixed Models Analysis|A mixed model with fixed effects for treatment, day, and interaction of treatment with day was performed using a compound symmetric covariance matrix.||||3.29|2.08|<0.0001
71151646|NCT02395081|141795401|SUPERIORITY|||||||0.7||||||SBP wk 16-20|ANOVA|||||||0.70
71151647|NCT02395081|141795403|SUPERIORITY|||||||0.49|||||||Chi-squared|||||||0.49
71151648|NCT02395081|141795404|SUPERIORITY|||||||0.79|||||||Chi-squared|||||||0.79
71151649|NCT02395081|141795406|SUPERIORITY|||||||0.83|||||||Chi-squared|||||||0.83
71151650|NCT02395081|141795407|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
71151651|NCT02395081|141795408|SUPERIORITY|||||||0.24|||||||ANOVA|||||||0.24
71090811|NCT00274456|141687924|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons was performed only if this test was significant."|Log Rank|||Investigator assessment||||0.013
71151652|NCT02395081|141795409|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
71151653|NCT02395081|141795410|SUPERIORITY|||||||0.89|||||||Chi-squared|||||||0.89
71151654|NCT02395081|141795411|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
71151655|NCT02141204|141795426|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% confidence interval (CI) for the ratio of anti-RV IgA antibody GMCs between HRV Liq Group over the HRV Lyo Group should be greater than or equal to (≥) 0.5.|GMC ratio|0.93|||||TWO_SIDED|95.0|0.65|1.34|||ANCOVA|95% CI for the adjusted GMC ratio and the logarithm of baseline concentration were used as fixed effects in this ANCOVA model.||Anti-RV IgA GMCs (non-inferiority): Non-inferiority comparison between GSK Biologicals' HRV liquid vaccine (HRV Liq Group) and GSK Biologicals' HRV lyophilized vaccine (HRV Lyo Group) in terms of geometric mean concentrations (GMCs) for anti-RV antibodies, one month after the administration of the second dose of study vaccine.||1.34|0.65|
71151656|NCT02963506|141795439|OTHER||Correlation statistic|17.9|||<|0.001|||||||Cochran-Mantel-Haenszel|||Statistic and p-value were calculated using a Cochran-Mantel-Haenszel test (test for non-zero correlation statistic) based on modified ridit scores and including geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure as stratification factors.||||<0.001
70906807|NCT03354637|141303279|SUPERIORITY||Odds Ratio (OR)|0.1||||0.157|TWO_SIDED|95.0|0.0|2.3|||Mixed Models Analysis|||||2.3|0.0|0.157
70906808|NCT03354637|141303279|SUPERIORITY||Odds Ratio (OR)|0.4||||0.353|TWO_SIDED|95.0|0.1|2.8|||Mixed Models Analysis|||||2.8|0.1|0.353
70906809|NCT03354637|141303280|SUPERIORITY||Odds Ratio (OR)|1.7||||0.333|TWO_SIDED|95.0|0.6|5.4|||Mixed Models Analysis|||||5.4|0.6|0.333
70906810|NCT03354637|141303280|SUPERIORITY||Odds Ratio (OR)|1.7||||0.388|TWO_SIDED|95.0|0.5|5.2|||Mixed Models Analysis|||||5.2|0.5|0.388
70906811|NCT03354637|141303281|SUPERIORITY||Odds Ratio (OR)|0.7||||0.435|TWO_SIDED|95.0|0.3|1.8|||Mixed Models Analysis|||||1.8|0.3|0.435
70906812|NCT03354637|141303281|SUPERIORITY||Odds Ratio (OR)|0.6||||0.37|TWO_SIDED|95.0|0.2|1.7|||Mixed Models Analysis|||||1.7|0.2|0.370
70906813|NCT03354637|141303282|SUPERIORITY||Odds Ratio (OR)|1.7||||0.333|TWO_SIDED|95.0|0.6|5.4|||Mixed Models Analysis|||||5.4|0.6|0.333
70906814|NCT03354637|141303282|SUPERIORITY||Odds Ratio (OR)|1.7||||0.388|TWO_SIDED|95.0|0.5|5.2|||Mixed Models Analysis|||||5.2|0.5|0.388
70906815|NCT03354637|141303283|SUPERIORITY|||||||0.505|||||||Wilcoxon (Mann-Whitney)|||||||0.505
70906816|NCT03354637|141303283|SUPERIORITY|||||||0.359|||||||Wilcoxon (Mann-Whitney)|||||||0.359
70906817|NCT03354637|141303284|SUPERIORITY|||||||0.602|||||||Wilcoxon (Mann-Whitney)|||||||0.602
70906818|NCT03354637|141303284|SUPERIORITY|||||||0.643|||||||Wilcoxon (Mann-Whitney)|||||||0.643
70906819|NCT03354637|141303285|SUPERIORITY|||||||0.992|||||||Wilcoxon (Mann-Whitney)|||||||0.992
70906820|NCT03354637|141303285|SUPERIORITY|||||||0.257|||||||Wilcoxon (Mann-Whitney)|||||||0.257
70906821|NCT03354637|141303287|SUPERIORITY|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||||||0.374
71090812|NCT00274456|141687924|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022|||||||Log Rank|||Investigator assessment||||0.022
71151657|NCT02963506|141795439|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|2.6|||=|0.04|TWO_SIDED|95.0|1.04|6.48||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior tumor necrosis factor (TNF) inhibitor exposure.||6.48|1.04|=0.040
71090813|NCT00274456|141687924|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
71151658|NCT02963506|141795439|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|4.5|||=|0.001|TWO_SIDED|95.0|1.83|10.86||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||10.86|1.83|=0.001
71151659|NCT02963506|141795439|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|5.5|||<|0.001|TWO_SIDED|95.0|2.27|13.48||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||13.48|2.27|<0.001
71151660|NCT02963506|141795439|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|5.3|||<|0.001|TWO_SIDED|95.0|2.19|12.92||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||12.92|2.19|<0.001
71090814|NCT00274456|141687924|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
71090815|NCT00274456|141687924|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Log Rank|||Investigator assessment||||0.005
71090816|NCT00274456|141687924|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
71090817|NCT00274456|141687924|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
71090818|NCT00274456|141687925|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047||95.0||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons were performed only if this test was significant."|Log Rank|||||||0.047
71090819|NCT00274456|141687925|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Log Rank|||||||>0.05
71090820|NCT00274456|141687925|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Log Rank|||||||>0.05
71090821|NCT00274456|141687925|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Log Rank|||||||>0.05
71090822|NCT00274456|141687925|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.686||||0.069||95.0|||||Log Rank|||||||0.069
71090823|NCT00274456|141687925|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Log Rank|||||||>0.05
70906822|NCT03354637|141303287|SUPERIORITY|||||||0.253|||||||Wilcoxon (Mann-Whitney)|||||||0.253
71090824|NCT00274456|141687925|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.74||||0.008||95.0|||||Log Rank|||||||0.008
71090825|NCT02314546|141687929|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Chi-squared|||||||0.99
71090826|NCT02314546|141687930|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Chi-squared|||||||0.99
71090827|NCT02314546|141687931|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Kruskal-Wallis|||||||0.26
71090828|NCT02314546|141687932|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Kruskal-Wallis|||||||0.02
71090829|NCT02314546|141687933|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Kruskal-Wallis|||||||0.04
71090830|NCT02314546|141687934|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||Chi-squared|||||||0.73
71090831|NCT02314546|141687935|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||Chi-squared|||||||0.73
71090832|NCT00375752|141687955|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.7||||0.106|TWO_SIDED|95.0|-1.8|31.1|||Fisher Exact|||||31.1|-1.8|0.106
71090833|NCT02034006|141687960|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|72.37|||<|0.0001|TWO_SIDED|95.0|23.44|223.42|||Regression, Logistic|||Presence vs. absence of active leakage.||223.42|23.44|<0.0001
71090834|NCT02034006|141687966|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.33|||<|0.0001|TWO_SIDED|95.0|3.18|27.36|||Regression, Logistic|||Presence vs. absence of macular edema.||27.36|3.18|<0.0001
71090835|NCT02034006|141687967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.66|||<|0.0001|TWO_SIDED|95.0|3.76|42.67|||Regression, Logistic|||Presence vs. absence of cysts.||42.67|3.76|<0.0001
71090836|NCT02034006|141687968|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|49.8|||<|0.0001|TWO_SIDED|95.0|11.62|213.5|||Regression, Logistic|||Presence vs. absence of intra-retinal fluid.||213.50|11.62|<0.0001
71090837|NCT02034006|141687969|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.1514|TWO_SIDED|95.0|0.99|1.0|||Regression, Logistic|||Change in Central subfield thickness vs previous visit.||1.00|0.99|0.1514
71090838|NCT02034006|141687970|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.1265|TWO_SIDED|95.0|0.0|5.63|||Regression, Logistic|||Change in Central subfield volume vs previous visit.||5.63|0.00|0.1265
71090839|NCT02034006|141687972|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.91||||0.0103|TWO_SIDED|95.0|1.58|30.23|||Regression, Logistic|||Presence vs. absence of clinically significant abnormalities.||30.23|1.58|0.0103
71090840|NCT02034006|141687973|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.0854|TWO_SIDED|95.0|0.9|5.33|||Regression, Logistic|||Gain \< 5 letters vs. Gain \>= 5 letters.||5.33|0.90|0.0854
71090841|NCT02034006|141687974|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.52||||0.0114|TWO_SIDED|95.0|1.23|5.17|||Regression, Logistic|||Gain \< 10 letters vs. Gain \>= 10 letters.||5.17|1.23|0.0114
71090842|NCT02034006|141687975|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.0049|TWO_SIDED|95.0|0.25|0.91|||Regression, Logistic|||Change from baseline in BCVA: Improved vs. No change. For retreated subjects, the last scheduled assessment prior to the first retreatment was considered. For subjects treated only once, the last scheduled assessment available was considered.||0.91|0.25|0.0049
71151661|NCT02963506|141795440|OTHER||LS Mean Difference vs placebo|-0.5|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-0.86|-0.24|||ANCOVA|||Least squares (LS) Mean, standard error, confidence interval and p-value were derived using the analysis of covariance (ANCOVA) model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.24|-0.86|<0.001
71151662|NCT02963506|141795440|OTHER||LS Mean Difference vs placebo|-1.2|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.47|-0.83|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.83|-1.47|<0.001
71151663|NCT02963506|141795440|OTHER||LS Mean Difference vs placebo|-1.0|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.35|-0.72|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.72|-1.35|<0.001
71151664|NCT02963506|141795440|OTHER||LS Mean Difference vs placebo|-1.1|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.45|-0.82|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.82|-1.45|<0.001
71151665|NCT02963506|141795441|OTHER||Odds Ratio (OR)|1.7|||=|0.163|TWO_SIDED|95.0|0.8|3.67||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||3.67|0.80|=0.163
71151666|NCT02963506|141795441|OTHER||Odds Ratio (OR)|3.9|||<|0.001|TWO_SIDED|95.0|1.84|8.48||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||8.48|1.84|<0.001
71151667|NCT02963506|141795441|OTHER||Odds Ratio (OR)|3.5|||=|0.001|TWO_SIDED|95.0|1.66|7.61||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||7.61|1.66|=0.001
71151668|NCT02963506|141795441|OTHER||Odds Ratio (OR)|6.5|||<|0.001|TWO_SIDED|95.0|2.92|14.28||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||14.28|2.92|<0.001
71151669|NCT02963506|141795442|OTHER||Odds Ratio (OR)|5.3|||=|0.003|TWO_SIDED|95.0|1.74|15.96||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||15.96|1.74|=0.003
71151670|NCT02963506|141795442|OTHER||Odds Ratio (OR)|11.9|||<|0.001|TWO_SIDED|95.0|4.03|35.38||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||35.38|4.03|<0.001
71151671|NCT02963506|141795442|OTHER||Odds Ratio (OR)|14.3|||<|0.001|TWO_SIDED|95.0|4.81|42.46||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||42.46|4.81|<0.001
71151672|NCT02963506|141795442|OTHER||Odds Ratio (OR)|14.9|||<|0.001|TWO_SIDED|95.0|5.02|44.27||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||44.27|5.02|<0.001
71151673|NCT02963506|141795443|OTHER||LS Mean Difference vs placebo|-0.6|STANDARD_ERROR_OF_MEAN|0.36|=|0.094|TWO_SIDED|95.0|-1.31|0.1|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||0.10|-1.31|=0.094
71151674|NCT02963506|141795443|OTHER||LS Mean Difference vs placebo|-1.6|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.34|-0.91|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.91|-2.34|<0.001
71151675|NCT02963506|141795443|OTHER||LS Mean Difference vs placebo|-1.6|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.35|-0.91|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.91|-2.35|<0.001
70906823|NCT03354637|141303289|SUPERIORITY|||||||0.102|||||||Wilcoxon (Mann-Whitney)|||||||0.102
70906824|NCT03354637|141303289|SUPERIORITY|||||||0.859|||||||Wilcoxon (Mann-Whitney)|||||||0.859
70906825|NCT03354637|141303290|SUPERIORITY|||||||0.481|||||||Wilcoxon (Mann-Whitney)|||||||0.481
70906826|NCT03354637|141303290|SUPERIORITY|||||||0.357|||||||Wilcoxon (Mann-Whitney)|||||||0.357
70906827|NCT02564055|141303292|OTHER||Difference in percentages|22.6|||||TWO_SIDED|95.0|-2.4|45.5|||||Difference between GSK2894512 1 percent BID and Vehicle BID has been presented.|||45.5|-2.4|
70906828|NCT02564055|141303292|OTHER||Difference in percentages|7.4|||||TWO_SIDED|95.0|-18.3|32.0|||||Difference between GSK2894512 1 percent QD and Vehicle QD has been presented.|||32.0|-18.3|
70906829|NCT02564055|141303292|OTHER||Difference in percentages|14.3|||||TWO_SIDED|95.0|-11.2|38.7|||||Difference between GSK2894512 0.5 percent BID and Vehicle BID has been presented.|||38.7|-11.2|
70906830|NCT02564055|141303292|OTHER||Difference in percentages|-4.0|||||TWO_SIDED|95.0|-29.3|21.6|||||Difference between GSK2894512 0.5 percent QD and Vehicle QD has been presented.|||21.6|-29.3|
71151676|NCT02963506|141795443|OTHER||LS Mean Difference vs placebo|-1.9|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-2.6|-1.18|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-1.18|-2.60|<0.001
71151677|NCT02963506|141795444|OTHER||LS Mean Difference vs placebo|-0.6|STANDARD_ERROR_OF_MEAN|0.36|=|0.075|TWO_SIDED|95.0|-1.35|0.07|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||0.07|-1.35|=0.075
71151678|NCT02963506|141795444|OTHER||LS Mean Difference vs placebo|-1.1|STANDARD_ERROR_OF_MEAN|0.36|=|0.003|TWO_SIDED|95.0|-1.79|-0.37|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.37|-1.79|=0.003
71151679|NCT02963506|141795444|OTHER||LS Mean Difference vs placebo|-1.1|STANDARD_ERROR_OF_MEAN|0.36|=|0.002|TWO_SIDED|95.0|-1.84|-0.42|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.42|-1.84|=0.002
71151680|NCT02963506|141795444|OTHER||LS Mean Difference vs placebo|-1.5|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-2.22|-0.81|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.81|-2.22|<0.001
71151681|NCT00750438|141795448|SUPERIORITY|||||||0.972|||||||Regression, Linear|||||||0.972
71151682|NCT00750438|141795449|SUPERIORITY|||||||0.559|||||||t-test, 2 sided|||Baseline and 24 weeks||||0.559
71151683|NCT00750438|141795449|SUPERIORITY|||||||0.062|||||||t-test, 2 sided|||Baseline to 24 weeks||||0.062
71151684|NCT00750438|141795449|SUPERIORITY|||||||0.099|||||||Regression, Linear|||||||0.099
71151685|NCT00750438|141795450|SUPERIORITY|||||||0.036|||||||Regression, Linear|||||||0.036
71151686|NCT00750438|141795451|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Baseline to 24 weeks||||0.001
70906831|NCT02564055|141303300|OTHER||Difference in percentages|21.1|||||TWO_SIDED|95.0|-2.7|43.1|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 1 has been presented.|||43.1|-2.7|
70968425|NCT00346073|141442807|SUPERIORITY||Booster response|77.2|||||TWO_SIDED|95.0|74.9|79.3||||||"Demonstration that anti-PT booster response occurred in at least 80% of adults receiving a single dose of Boostrix® vaccine, one month after vaccination.~Criterion for evaluation: one month after vaccination, the lower limit of the 95% confidence interval (CI) for the percentage of subjects with a booster response was greater than or equal to (≥) 80%."||79.3|74.9|
71151687|NCT00750438|141795451|SUPERIORITY|||||||0.723|||||||t-test, 2 sided|||Baseline to 24 weeks||||0.723
71151688|NCT00750438|141795451|SUPERIORITY|||||||0.027|||||||Regression, Linear|||||||0.027
71151689|NCT00750438|141795452|SUPERIORITY|||||||0.372|||||||t-test, 2 sided|||||||0.372
71151690|NCT00750438|141795452|SUPERIORITY|||||||0.644|||||||t-test, 2 sided|||||||0.644
71090843|NCT02034006|141687975|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.53||||0.0461|TWO_SIDED|95.0|0.69|44.52|||Regression, Logistic|||Change from baseline in BCVA: Worsened vs. No change||44.52|0.69|0.0461
71151691|NCT00750438|141795452|SUPERIORITY|||||||0.549|||||||Regression, Linear|||||||0.549
71151692|NCT04845568|141795478|SUPERIORITY||Mean Difference (Net)|1.13|STANDARD_ERROR_OF_MEAN|2.08||0.592|TWO_SIDED|95.0|-3.16|5.43||A priori threshold for statistical significance was set at p\<0.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in Self-Efficacy for Physical Activity. It is an independent samples t test. It is testing the null hypothesis that the mean change in self-efficacy for physical activity does not differ between conditions.||5.43|-3.16|0.592
70906832|NCT02564055|141303300|OTHER||Difference in percentages|26.5|||||TWO_SIDED|95.0|3.3|47.5|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 1 has been presented.|||47.5|3.3|
70906833|NCT02564055|141303300|OTHER||Difference in percentages|2.3|||||TWO_SIDED|95.0|-19.5|24.5|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 1 has been presented.|||24.5|-19.5|
70906834|NCT02564055|141303300|OTHER||Difference in percentages|9.1|||||TWO_SIDED|95.0|-14.5|32.0|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 1 has been presented.|||32.0|-14.5|
70968426|NCT00346073|141442807|SUPERIORITY||Booster response|96.9|||||TWO_SIDED|95.0|95.8|97.7||||||"Demonstration that anti-FHA booster response occurred in at least 80% of adults receiving a single dose of Boostrix® vaccine, one month after vaccination.~Criterion for evaluation: one month after vaccination, the lower limit of the 95% confidence interval (CI) for the percentage of subjects with a booster response was greater than or equal to (≥) 80%."||97.7|95.8|
71090844|NCT01499511|141687996|SUPERIORITY|||||||0.624|||||||ANOVA|||||||0.624
71090845|NCT01499511|141687997|SUPERIORITY|||||||0.004|||||||ANOVA|||||||0.004
71151693|NCT04845568|141795478|SUPERIORITY||Mean Difference (Net)|-1.19|STANDARD_ERROR_OF_MEAN|1.56||0.453|TWO_SIDED|95.0|-4.39|2.02||A priori threshold for statistical significance was set at p\<0.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in Self-Efficacy for Healthy Eating. It is an independent samples t test. It is testing the null hypothesis that the mean change in self-efficacy for healthy eating does not differ between conditions.||2.02|-4.39|0.453
71151694|NCT04845568|141795479|SUPERIORITY||Mean Difference (Net)|0.275|STANDARD_ERROR_OF_MEAN|0.3||0.368|TWO_SIDED|95.0|-0.342|0.892||A priori threshold for statistical significance set at p\< 0.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in Caregiver Readiness to Change Child's Eating. It is an independent samples t test. It is testing the null hypothesis that the mean change in readiness for healthy eating does not differ between conditions.||.892|-.342|.368
71151695|NCT04845568|141795479|SUPERIORITY||Mean Difference (Net)|0.126|STANDARD_ERROR_OF_MEAN|0.34||0.714|TWO_SIDED|95.0|-0.575|0.827||A priori threshold for statistical significance set at p\< .05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in Caregiver Readiness for Physical Activity. It is an independent samples t test. It is testing the null hypothesis that the mean change in caregiver intentions to help child improve physical activity from baseline to two-week follow up does not differ between conditions.||.827|-.575|.714
71151696|NCT04845568|141795480|SUPERIORITY||Mean Difference (Net)|-0.522|STANDARD_ERROR_OF_MEAN|1.88||0.783|TWO_SIDED|95.0|-4.39|3.34||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child attitudes toward healthy eating. It is an independent samples t test. It is testing the null hypothesis that the mean change in child attitudes toward healthy eating from baseline to post-intervention does not differ between conditions.||3.34|-4.39|.783
71151697|NCT04845568|141795480|SUPERIORITY||Mean Difference (Net)|-1.99|STANDARD_ERROR_OF_MEAN|1.97||0.323|TWO_SIDED|95.0|-6.05|2.07||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child intentions toward healthy eating. It is an independent samples t test. It is testing the null hypothesis that the mean change in child intentions toward healthy eating from baseline to post-intervention does not differ between conditions.||2.07|-6.05|.323
71151698|NCT04845568|141795480|SUPERIORITY||Mean Difference (Net)|2.11|STANDARD_ERROR_OF_MEAN|1.89||0.276|TWO_SIDED|95.0|-1.79|6.01||A priori threshold for statistical significance is set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in caregiver intentions toward helping their child engage in healthy eating. It is an independent samples t test. It is testing the null hypothesis that the mean change in caregiver intentions from baseline to post-intervention does not differ between conditions.||6.01|-1.79|.276
71151699|NCT04845568|141795481|SUPERIORITY||Mean Difference (Net)|0.247|STANDARD_ERROR_OF_MEAN|0.4||0.547|TWO_SIDED|95.0|-0.59|1.08||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child intake of fruits. It is an independent samples t test. It is testing the null hypothesis that the mean change in child fruit servings per week from baseline to two-week follow up does not differ between conditions.||1.08|-.59|.547
71151700|NCT04845568|141795481|SUPERIORITY||Mean Difference (Net)|-0.005|STANDARD_ERROR_OF_MEAN|0.42||0.99|TWO_SIDED|95.0|-0.87|0.86||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child intake of vegetables. It is an independent samples t test. It is testing the null hypothesis that the mean change in child vegetable servings per week from baseline to two-week follow up does not differ between conditions.||.86|-.87|.990
71151701|NCT04845568|141795481|SUPERIORITY||Mean Difference (Net)|-0.203|STANDARD_ERROR_OF_MEAN|0.32||0.527|TWO_SIDED|95.0|-0.86|0.45||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child intake of fast food. It is an independent samples t test. It is testing the null hypothesis that the mean change in child fast food servings per week from baseline to two-week follow up does not differ between conditions.||.45|-.86|.527
71151702|NCT04845568|141795482|SUPERIORITY||Mean Difference (Net)|-0.159|STANDARD_ERROR_OF_MEAN|0.55||0.777|TWO_SIDED|95.0|-1.33|1.01||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child weekly intake of breakfast. It is an independent samples t test. It is testing the null hypothesis that the mean change in child breakfast meals per week from baseline to two-week follow up does not differ between conditions.||1.01|-1.33|.777
71151703|NCT04845568|141795482|SUPERIORITY||Mean Difference (Net)|-0.736|STANDARD_ERROR_OF_MEAN|0.74||0.329|TWO_SIDED|95.0|-2.26|0.79||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child intake of family dinners. It is an independent samples t test. It is testing the null hypothesis that the mean change in child family dinners per week from baseline to two-week follow up does not differ between conditions.||.79|-2.26|.329
71151704|NCT04845568|141795483|SUPERIORITY||Mean Difference (Net)|0.46|STANDARD_ERROR_OF_MEAN|0.26||0.086|TWO_SIDED|95.0|-0.07|0.99||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child screentime. It is an independent samples t test. It is testing the null hypothesis that the mean change in child screentime per week from baseline to two-week follow up does not differ between conditions.||.99|-0.07|.086
71151705|NCT04845568|141795483|SUPERIORITY||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.25||0.64|TWO_SIDED|95.0|-0.64|0.4||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child active hours. It is an independent samples t test. It is testing the null hypothesis that the mean change in child active hours per week from baseline to two-week follow up does not differ between conditions.||.40|-.64|.64
71151706|NCT02908672|141795513|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.0224|TWO_SIDED|95.0|0.64|0.97|||Log Rank||Stratified Hazard Ratio|||0.97|0.64|0.0224
71151707|NCT02908672|141795514|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.1607|TWO_SIDED|95.0|0.67|1.07|||Log Rank||Stratified Hazard Ratio|||1.07|0.67|0.1607
71151708|NCT02908672|141795515|SUPERIORITY||Difference in response rate|1.63||||0.6997|TWO_SIDED|95.0|-6.9|10.15|||Cochran-Mantel-Haenszel|||||10.15|-6.90|0.6997
71151709|NCT02908672|141795517|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.1191|TWO_SIDED|95.0|0.67|1.05|||Log Rank|||||1.05|0.67|0.1191
70906835|NCT02564055|141303300|OTHER||Difference in percentages|23.1|||||TWO_SIDED|95.0|-0.3|44.6|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 2 has been presented.|||44.6|-0.3|
71090846|NCT01499511|141687998|SUPERIORITY|||||||0.304|||||||ANOVA|||||||0.304
70906836|NCT02564055|141303300|OTHER||Difference in percentages|37.7|||||TWO_SIDED|95.0|14.7|57.6|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 2 has been presented.|||57.6|14.7|
70968427|NCT00346073|141442807|SUPERIORITY||Booster response|93.2|||||TWO_SIDED|95.0|91.8|94.4||||||"Demonstration that anti-PRN booster response occurred in at least 80% of adults receiving a single dose of Boostrix® vaccine, one month after vaccination.~Criterion for evaluation: one month after vaccination, the lower limit of the 95% confidence interval (CI) for the percentage of subjects with a booster response was greater than or equal to (≥) 80%."||94.4|91.8|
70968428|NCT04342871|141442828|OTHER|Pre-post comparison from baseline to 2-weeks post-intervention||||||0.2|||||||t-test, 2 sided|||||||0.2
71090847|NCT01499511|141687999|SUPERIORITY|||||||0.641|||||||ANOVA|||||||0.641
71090848|NCT01499511|141688000|SUPERIORITY|||||||0.915|||||||ANOVA|||||||0.915
71090849|NCT02081807|141688005|OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.57|1.76|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||1.76|0.57|
71151710|NCT02908672|141795518|SUPERIORITY||Difference in Event Free Rate|8.2||||0.0693|TWO_SIDED|95.0|-0.65|17.04|||Z-test|||||17.04|-0.65|0.0693
71151711|NCT01732718|141795536|SUPERIORITY|||||||0.51|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.51
71151712|NCT01732718|141795537|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
71151713|NCT01732718|141795539|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
71151714|NCT01732718|141795541|SUPERIORITY|||||||0.57|||||||see comments for explanation|albuminuria examined as continuous variable (linear mixed model to analyze effect) and categorical generalized variable (estimating equation approach)||||||0.57
71151715|NCT01732718|141795545|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
71151716|NCT01732718|141795546|SUPERIORITY|||||||0.1469|||||||t-test, 1 sided|||Comparison of the change in AMC||||0.1469
71151717|NCT01732718|141795546|SUPERIORITY|||||||0.2382|||||||t-test, 1 sided|||Comparison of the change in ALC||||0.2382
71151718|NCT01732718|141795546|SUPERIORITY|||||||0.5833|||||||t-test, 1 sided|||Comparison of the change in ANC||||0.5833
71151719|NCT01732718|141795549|SUPERIORITY|||||||0.5184|||||||Wilcoxon (Mann-Whitney)|||||||0.5184
71151720|NCT02223702|141795555|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Friedman Test|All rows were compared to eachother||||||<0.01
71151721|NCT02223702|141795556|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANOVA|All rows were compared to eachother||||||<0.01
71151722|NCT00499616|141795572|OTHER||Log Rank Test Statistic|0.9841||||0.3212|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients between 12-18 months of age with Stage 4 neuroblastoma and favorable biological features on ANBL0531 and patients less than 12 months of age with Stage 4 neuroblastoma on A3961 were compared using the log-rank test.||||.3212
71151723|NCT00499616|141795576|OTHER||Log-Rank Test Statistic|5.0049||||0.0253|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients with complete surgical resection and patients without complete surgical resection were compared using the log-rank test.||||.0253
71151724|NCT00499616|141795577|OTHER|The overall survival distributions of patients with complete surgical resection and patients without complete surgical resection were compared using the log-rank test.|Log Rank Test Statistic|2.6709||||0.1022|TWO_SIDED|95.0|||||Log Rank|||||||.1022
71151725|NCT00499616|141795578|OTHER||Chi-Square Test Statistic|9.9111||||0.0016|TWO_SIDED|95.0|||||Chi-squared|||The association between extent of surgical resection with occurrence of complications was determined using the chi-square test.||||.0016
71090850|NCT02081807|141688005|OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.52|0.94|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||MarketScan-Dabigatran vs. Warfarin (as reference group).||0.94|0.52|
71151726|NCT00826462|141795614|OTHER||||||<|0.01|||||||linear generalized estimating equations||||A linear GEE regression model adjusted for the significant covariates at p \< 0.05 from the univariate GEE logistic regression models calculated for success|||<0.01
71151727|NCT00826462|141795614|OTHER||||||<|0.01|||||||linear generalized estimating equations|||||||<0.01
71151728|NCT00826462|141795618|OTHER||||||||||||||||||linear generalized estimating equations (GEE) regression model adjusted for significant covariates; between groups estimated odds ratio (OR) for no pain on two isometric movements using logistic GEE regression model adjusted for significant covariates; 99 % confidence intervals|||
71151729|NCT00220636|141795641|SUPERIORITY_OR_OTHER||t statistic|4.7|||<|0.001|TWO_SIDED|95.0|||||t-test, 2 sided|df=13||Null hypothesis would be no change in the HDRS score pre- to post- treatment with aripiprazole.||||<.001
71151730|NCT00220636|141795643|SUPERIORITY_OR_OTHER||t statistic|-3.1||||0.009|TWO_SIDED|95.0|||||t-test, 2 sided|df=13||Null hypothesis would be no change in the GAFS score pre- to post- treatment with aripiprazole.||||.009
71151731|NCT00220636|141795644|SUPERIORITY_OR_OTHER||t statistic|3.1||||0.008|TWO_SIDED|95.0|||||t-test, 2 sided|df=13||Null hypothesis would be no change in the BDI score pre- to post- treatment with aripiprazole.||||.008
71151732|NCT00539942|141795652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|||<|0.05|||||||Chi-squared|||Unable to analyze data||||<.05
71151733|NCT05814367|141795662|NON_INFERIORITY|A non-inferiority margin of 0.05 logMAR was used.|Least-square Mean Difference|-0.005|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.025|0.014|||Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Test minus Control|The sample size of 38 was calculated to provide at least 90% statistical power to test Non-inferiority of the Test lens compared to the Control lens using a paired t-test with a two-sided type I error rate of 5%.||0.014|-0.025|
71151734|NCT00880919|141795666|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANOVA|||Mean changes were calculated using each groups linear and quadratic effects||||.015
71151735|NCT00408200|141795700|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
71151736|NCT02015637|141795704|NON_INFERIORITY|Two-sided 95% confidence intervals (CIs) using the Wald test was constructed for comparisons between delafloxacin and ceftriaxone. A hierarchical approach was implemented for the primary and secondary analyses to control for the overall type 1 error rate of 0.05 due to multiple comparisons.|Difference in cure rate|-5.9|||||TWO_SIDED|95.0|-13.18|1.36||||||||1.36|-13.18|
71151737|NCT02015637|141795705|NON_INFERIORITY|Two-sided 95% confidence intervals (CIs) using the Wald test was constructed for comparisons between delafloxacin and ceftriaxone. A hierarchical approach was implemented for the primary and secondary analyses to control for the overall type 1 error rate of 0.05 due to multiple comparisons.|Difference in cure rates|-9.9|||||TWO_SIDED|95.0|-16.03|-3.87||||||||-3.87|-16.03|
71151738|NCT02106390|141795725|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ is \> 0.5 for all serogroup B indicator strains.|GMT ratio|0.89|||||TWO_SIDED|95.0|0.71|1.1|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||"H44/76- The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the H44/76 serogroup B indicator strain,at one month after the fourth vaccination."||1.10|0.71|
71151739|NCT02106390|141795725|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ is \> 0.5 for all serogroup B indicator strains.|GMT ratio|1.03|||||TWO_SIDED|95.0|0.74|1.45|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||5/99-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the 5/99 serogroup B indicator strain,at one month after the fourth vaccination.||1.45|0.74|
71151740|NCT02106390|141795725|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ is \> 0.5 for all serogroup B indicator strains.|GMT ratio|1.01|||||TWO_SIDED|95.0|0.82|1.25|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||NZ98/254-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the NZ98/254 serogroup B indicator strain,at one month after the fourth vaccination.||1.25|0.82|
71151741|NCT02106390|141795725|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ is \> 0.5 for all serogroup B indicator strains.|GMT ratio|1.03|||||TWO_SIDED|95.0|0.77|1.4|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||M10713-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the M10713 serogroup B indicator strain,at one month after the fourth vaccination.||1.40|0.77|
71151742|NCT02106390|141795726|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMVNZ + MenACWY versus MenACWY) was \> 0.5 for all serogroups A, C, W-135 and Y.|GMT ratio|2.48|||||TWO_SIDED|95.0|1.97|3.11|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||Serogroup A-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + Men ACWY versus MenACWY) was performed for serogroup A at one month after the fourth vaccination.||3.11|1.97|
71151743|NCT02106390|141795726|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMVNZ + MenACWY versus MenACWY) was \> 0.5 for all serogroups A, C, W-135 and Y.|GMT ratio|1.07|||||TWO_SIDED|95.0|0.83|1.38|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||Serogroup C-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + Men ACWY versus MenACWY) was performed for the serogroup C at one month after the fourth vaccination.||1.38|0.83|
71151744|NCT02106390|141795726|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMVNZ + MenACWY versus MenACWY) was \> 0.5 for all serogroups A, C, W-135 and Y.|GMT ratio|1.34|||||TWO_SIDED|95.0|1.04|1.74|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||Serogroup W-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + Men ACWY versus MenACWY) was performed for the serogroup W-135 at one month after the fourth vaccination.||1.74|1.04|
71151745|NCT02106390|141795726|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMVNZ + MenACWY versus MenACWY) was \> 0.5 for all serogroups A, C, W-135 and Y.|GMT ratio|1.05|||||TWO_SIDED|95.0|0.82|1.35|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||Serogroup Y-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + Men ACWY versus MenACWY) was performed for the serogroup Y at one month after the fourth vaccination.||1.35|0.82|
71151746|NCT03198507|141795758|SUPERIORITY|||||||0.0001|TWO_SIDED|95.0||||Statistical testing was 2 sided and performed using a significance (alpha) level of 0.05.|t-test, 2 sided|||||||0.0001
71151747|NCT03198507|141795761|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
71151748|NCT00241839|141795770|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.27|STANDARD_ERROR_OF_MEAN|2.24||0.059|TWO_SIDED|95.0|-0.17|8.7|||t-test, 2 sided|Satterthwaite correction for possibly unequal variance was made|A positive value of the estimated value would favor the allopurinol arm. The analysis is limited to those with both baseline and 8-10 week data on this variable.|We compared the drop in baseline of diastolic BP for the two treatment groups Allopurinol vs. Placebo by a Satterthwaite corrected t-test.||8.7|-0.17|0.059
71151749|NCT00241839|141795771|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.16|STANDARD_ERROR_OF_MEAN|1.59||0.47|TWO_SIDED|95.0|-2.0|4.3||Positive numbers indicate a drop. We compared baseline minus value at treatment end for the two treatments.|t-test, 2 sided|Satterthwaite correction was used for potentially unequal variances.|The analysis is limited to those with both baseline and 8-10 week data on this variable.|||4.3|-2.0|0.47
71151750|NCT00241839|141795772|SUPERIORITY_OR_OTHER||Median Difference (Net)|-6.76|STANDARD_ERROR_OF_MEAN|2.11||0.002|TWO_SIDED|95.0|-11.0|-2.6|||t-test, 2 sided|Sattherthwaite correction was used|The analysis is limited to those with both baseline and 8-10 week data on this variable. The 24 hour was in the opposite direction of the cuff.|||-2.6|-11.0|0.0020
71090851|NCT02081807|141688005|OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.58|0.98|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.98|0.58|
71090852|NCT02081807|141688005|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.53|1.35|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.35|0.53|
71151751|NCT00241839|141795773|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.15|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|1.72|2.59|||t-test, 2 sided|Satterthwaite correction was used.|Allopurinol was associated with a significant decrease in uric acid over the treatment period as compared to placebo. The analysis is limited to those with both baseline and 8-10 week data on this variable.|We expected allopurinol to be associated with a decrease in uric acid.||2.59|1.72|<0.001
71151752|NCT00439517|141795774|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.677||||0.0048|TWO_SIDED|95.0|0.515|0.889|||Stratified log rank|Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||0.889|0.515|0.0048
71151753|NCT00439517|141795775|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.756||||0.016|TWO_SIDED|95.0|1.11|2.777|||Cochran-Mantel-Haenszel|Stratified odds ratio and Cochran-Mantel- Haenszel (CMH) statistics were calculated considering the randomization strata.||||2.777|1.110|0.016
71151754|NCT00439517|141795776|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.855||||0.3797|TWO_SIDED|95.0|0.603|1.213|||Stratified log rank|Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||1.213|0.603|0.3797
71151755|NCT00439517|141795777|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.977||||0.8575|TWO_SIDED|95.0|0.755|1.263|||Stratified log rank||Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.|||1.263|0.755|0.8575
71151756|NCT02304367|141795784|OTHER|||||||0.0428|||||||t-test|||The null hypothesis that the mean change from Baseline to Week 48 in osteoid thickness is zero was tested using a t-test.||||0.0428
71151757|NCT02304367|141795785|OTHER|||||||0.977|||||||t-test|||The null hypothesis that the mean change from Baseline to Week 48 in OS/BS is zero was tested using a t-test.||||0.9770
70906837|NCT02564055|141303300|OTHER||Difference in percentages|5.1|||||TWO_SIDED|95.0|-18.0|27.8|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 2 has been presented.|||27.8|-18.0|
70906838|NCT02564055|141303300|OTHER||Difference in percentages|17.1|||||TWO_SIDED|95.0|-6.4|39.0|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 2 has been presented.|||39.0|-6.4|
70906839|NCT02564055|141303300|OTHER||Difference in percentages|39.6|||||TWO_SIDED|95.0|16.0|60.0|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 4 has been presented.|||60.0|16.0|
70906840|NCT02564055|141303300|OTHER||Difference in percentages|31.2|||||TWO_SIDED|95.0|7.8|52.1|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 4 has been presented.|||52.1|7.8|
70906841|NCT02564055|141303300|OTHER||Difference in percentages|26.5|||||TWO_SIDED|95.0|2.3|48.4|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 4 has been presented.|||48.4|2.3|
71151758|NCT02304367|141795786|OTHER|||||||0.0858|||||||t-test|||The null hypothesis that the mean change from Baseline to Week 48 in OV/BV is zero was tested using a t-test.||||0.0858
71151759|NCT02304367|141795787|OTHER|||||||0.4077|||||||t-test|||The null hypothesis that the mean change from Baseline to Week 48 in Mlt is zero was tested using a t-test.||||0.4077
71151760|NCT02304367|141795794|OTHER|||||||0.016|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 24||||0.016
71151761|NCT02304367|141795794|OTHER|||||||0.03|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 48||||0.030
71151762|NCT02304367|141795794|OTHER|||||||0.259|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 96||||0.259
71151763|NCT02304367|141795794|OTHER|||||||0.346|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 144||||0.346
71151764|NCT02304367|141795794|OTHER|||||||0.213|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 168||||0.213
70906842|NCT02564055|141303300|OTHER||Difference in percentages|18.3|||||TWO_SIDED|95.0|-5.3|40.5|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 4 has been presented.|||40.5|-5.3|
70906843|NCT02564055|141303300|OTHER||Difference in percentages|21.9|||||TWO_SIDED|95.0|-2.3|44.7|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 8 has been presented.|||44.7|-2.3|
70906844|NCT02564055|141303300|OTHER||Difference in percentages|36.3|||||TWO_SIDED|95.0|12.1|57.6|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 8 has been presented.|||57.6|12.1|
70906845|NCT02564055|141303300|OTHER||Difference in percentages|26.7|||||TWO_SIDED|95.0|1.7|49.0|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 8 has been presented.|||49.0|1.7|
70906846|NCT02564055|141303300|OTHER||Difference in percentages|23.4|||||TWO_SIDED|95.0|-1.5|46.1|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 8 has been presented.|||46.1|-1.5|
70906847|NCT02564055|141303300|OTHER||Difference in percentages|19.0|||||TWO_SIDED|95.0|-6.0|42.3|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 12 has been presented.|||42.3|-6.0|
70906848|NCT02564055|141303300|OTHER||Difference in percentages|-0.2|||||TWO_SIDED|95.0|-25.0|25.0|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 12 has been presented.|||25.0|-25.0|
70906849|NCT02564055|141303300|OTHER||Difference in percentages|32.6|||||TWO_SIDED|95.0|6.9|55.0|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 12 has been presented.|||55.0|6.9|
70906850|NCT02564055|141303300|OTHER||Difference in percentages|-9.7|||||TWO_SIDED|95.0|-34.6|16.1|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 12 has been presented.|||16.1|-34.6|
71151765|NCT02304367|141795794|OTHER|||||||0.873|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 192||||0.873
71151766|NCT02304367|141795794|OTHER|||||||0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 216||||0.001
71151767|NCT02304367|141795794|OTHER|||||||0.04|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 240||||0.040
71151768|NCT02304367|141795795|OTHER||||||<|0.0001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 24||||<0.0001
71151769|NCT02304367|141795795|OTHER||||||<|0.0001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 48||||<0.0001
70906851|NCT02564055|141303300|OTHER||Difference in percentages|22.3|||||TWO_SIDED|95.0|-3.1|45.3|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 14 has been presented.|||45.3|-3.1|
71151770|NCT02304367|141795795|OTHER|||||||0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 96||||0.001
71151771|NCT02304367|141795795|OTHER|||||||0.007|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 144||||0.007
71151772|NCT02304367|141795795|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 168||||0.005
71151773|NCT02304367|141795795|OTHER|||||||0.004|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 192||||0.004
71151774|NCT02304367|141795795|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 216||||0.002
71151775|NCT02304367|141795795|OTHER|||||||0.006|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 240||||0.006
71151776|NCT02304367|141795796|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 24||||< 0.001
71151777|NCT02304367|141795796|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 48||||< 0.001
71151778|NCT02304367|141795796|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 96||||<0.001
71151779|NCT02304367|141795796|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 144||||< 0.001
71151780|NCT02304367|141795796|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 168||||< 0.001
71151781|NCT02304367|141795796|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 192||||< 0.001
71151782|NCT02304367|141795796|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 216||||< 0.001
71151783|NCT02304367|141795796|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 240||||< 0.001
71151784|NCT02304367|141795797|OTHER|||||||0.659|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 24||||0.659
71151785|NCT02304367|141795797|OTHER|||||||0.752|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 48||||0.752
71151786|NCT02304367|141795797|OTHER|||||||0.594|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 96||||0.594
71151787|NCT02304367|141795797|OTHER|||||||0.614|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 144||||0.614
71151788|NCT02304367|141795797|OTHER|||||||0.542|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 168||||0.542
71151789|NCT02304367|141795797|OTHER|||||||0.067|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 192||||0.067
71151790|NCT02304367|141795797|OTHER|||||||0.33|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 216||||0.330
70906852|NCT02564055|141303300|OTHER||Difference in percentages|6.3|||||TWO_SIDED|95.0|-19.5|31.5|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 14 has been presented.|||31.5|-19.5|
70906853|NCT02564055|141303300|OTHER||Difference in percentages|17.7|||||TWO_SIDED|95.0|-8.4|41.9|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 14 has been presented.|||41.9|-8.4|
70906854|NCT02564055|141303300|OTHER||Difference in percentages|7.8|||||TWO_SIDED|95.0|-17.8|33.1|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 14 has been presented.|||33.1|-17.8|
71151791|NCT02304367|141795797|SUPERIORITY|||||||0.161|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 240||||0.161
71151792|NCT02304367|141795798|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 24||||< 0.001
71151793|NCT02304367|141795798|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 48||||< 0.001
71151794|NCT02304367|141795798|OTHER|||||||0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 96||||0.001
71151795|NCT02304367|141795798|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 144||||< 0.001
71151796|NCT02304367|141795798|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 168||||< 0.001
71151797|NCT02304367|141795798|SUPERIORITY||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 192||||< 0.001
71151798|NCT02304367|141795798|SUPERIORITY||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 216||||< 0.001
71151799|NCT02304367|141795798|SUPERIORITY||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 240||||< 0.001
71151800|NCT02304367|141795799|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR||Week 24||||< 0.001
70906855|NCT02564055|141303300|OTHER||Difference in percentages|9.8|||||TWO_SIDED|95.0|-15.5|33.9|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 16 has been presented.|||33.9|-15.5|
71090853|NCT02081807|141688005|OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.57|0.98|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||MarketScan-Rivaroxaban vs. Warfarin (as reference group).||0.98|0.57|
71151801|NCT02304367|141795799|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR||Week 48||||< 0.001
71151802|NCT02304367|141795799|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR||Week 96||||0.002
71151803|NCT02304367|141795799|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR||Week 144||||< 0.001
71151804|NCT02304367|141795799|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR.||Week 168||||< 0.001
71151805|NCT02304367|141795799|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR.||Week 192||||< 0.001
71151806|NCT02304367|141795799|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR.||Week 216||||< 0.001
71151807|NCT02304367|141795799|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR.||Week 240||||< 0.001
71151808|NCT02304367|141795800|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 24||||< 0.001
71151809|NCT02304367|141795800|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 48||||< 0.001
71151810|NCT02304367|141795800|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 96||||< 0.001
70906856|NCT02564055|141303300|OTHER||Difference in percentages|5.8|||||TWO_SIDED|95.0|-19.7|30.5|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 16 has been presented.|||30.5|-19.7|
70906857|NCT02564055|141303300|OTHER||Difference in percentages|17.2|||||TWO_SIDED|95.0|-9.0|41.4|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 16 has been presented.|||41.4|-9.0|
71151811|NCT02304367|141795800|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 144||||< 0.001
71151812|NCT02304367|141795800|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 168||||< 0.001
71151813|NCT02304367|141795800|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 192||||< 0.001
71151814|NCT02304367|141795800|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 216||||< 0.001
71151815|NCT02304367|141795800|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 240||||< 0.001
71151816|NCT02304367|141795801|OTHER|||||||0.878|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 24||||0.878
70906858|NCT02564055|141303300|OTHER||Difference in percentages|-0.6|||||TWO_SIDED|95.0|-26.0|25.0|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 16 has been presented.|||25.0|-26.0|
70906859|NCT02564055|141303300|OTHER||Difference in percentages|33.3|||||TWO_SIDED|95.0|-31.9|90.6|||||Difference between GSK2894512 1 % BID and Vehicle BID at EW has been presented.|||90.6|-31.9|
70906860|NCT02564055|141303300|OTHER||Difference in percentages|-9.1|||||TWO_SIDED|95.0|-62.4|47.8|||||Difference between GSK2894512 1 % QD and Vehicle QD at EW has been presented.|||47.8|-62.4|
70906861|NCT02564055|141303300|OTHER||Difference in percentages|28.6|||||TWO_SIDED|95.0|-19.2|71.0|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at EW has been presented.|||71.0|-19.2|
70906862|NCT02564055|141303300|OTHER||Difference in percentages|24.2|||||TWO_SIDED|95.0|-40.3|80.9|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at EW has been presented.|||80.9|-40.3|
71090854|NCT02081807|141688005|OTHER||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.61|0.98|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||0.98|0.61|
71151817|NCT02304367|141795801|OTHER|||||||0.081|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 48||||0.081
71151818|NCT02304367|141795801|OTHER|||||||0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 96||||0.001
71151819|NCT02304367|141795801|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 144||||< 0.001
71151820|NCT02304367|141795801|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 168||||< 0.001
71151821|NCT02304367|141795801|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 192||||< 0.001
71151822|NCT02304367|141795801|OTHER|||||||0.055|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 216||||0.055
71151823|NCT02304367|141795801|OTHER|||||||0.041|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 240||||0.041
71151824|NCT02304367|141795802|OTHER|||||||0.817|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 24||||0.817
71151825|NCT02304367|141795802|OTHER|||||||0.042|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 48||||0.042
70906863|NCT02564055|141303301|OTHER||Difference in percentages|5.3|||||TWO_SIDED|95.0|-18.3|28.4|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 1 has been presented.|||28.4|-18.3|
70906864|NCT02564055|141303301|OTHER||Difference in percentages|5.9|||||TWO_SIDED|95.0|-17.1|28.4|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 1 has been presented.|||28.4|-17.1|
70906865|NCT02564055|141303301|OTHER||Difference in percentages|-0.8|||||TWO_SIDED|95.0|-24.0|22.7|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 1 has been presented.|||22.7|-24.0|
71151826|NCT02304367|141795802|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 96||||< 0.001
71151827|NCT02304367|141795802|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 144||||< 0.001
70906866|NCT02564055|141303301|OTHER||Difference in percentages|11.4|||||TWO_SIDED|95.0|-12.0|33.9|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 2 has been presented.|||33.9|-12.0|
70906867|NCT02564055|141303301|OTHER||Difference in percentages|30.2|||||TWO_SIDED|95.0|6.8|51.0|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 2 has been presented.|||51.0|6.8|
71151828|NCT02304367|141795802|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 168||||< 0.001
70906868|NCT02564055|141303301|OTHER||Difference in percentages|3.7|||||TWO_SIDED|95.0|-19.4|26.6|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 2 has been presented.|||26.6|-19.4|
70906869|NCT02564055|141303301|OTHER||Difference in percentages|17.4|||||TWO_SIDED|95.0|-6.0|39.5|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 2 has been presented.|||39.5|-6.0|
70906870|NCT02564055|141303301|OTHER||Difference in percentages|16.8|||||TWO_SIDED|95.0|-7.1|39.4|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 4 has been presented.|||39.4|-7.1|
70906871|NCT02564055|141303301|OTHER||Difference in percentages|41.9|||||TWO_SIDED|95.0|19.2|61.2|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 4 has been presented.|||61.2|19.2|
70906872|NCT02564055|141303301|OTHER||Difference in percentages|8.9|||||TWO_SIDED|95.0|-14.9|32.0|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 4 has been presented.|||32.0|-14.9|
70906873|NCT02564055|141303301|OTHER||Difference in percentages|16.3|||||TWO_SIDED|95.0|-7.3|38.3|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 4 has been presented.|||38.3|-7.3|
71090855|NCT02081807|141688005|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.53|1.51|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||1.51|0.53|
70906874|NCT02564055|141303301|OTHER||Difference in percentages|13.4|||||TWO_SIDED|95.0|-11.3|36.5|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 8 has been presented.|||36.5|-11.3|
70906875|NCT02564055|141303301|OTHER||Difference in percentages|30.8|||||TWO_SIDED|95.0|6.1|52.8|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 8 has been presented.|||52.8|6.1|
70906876|NCT02564055|141303301|OTHER||Difference in percentages|21.9|||||TWO_SIDED|95.0|-3.0|44.9|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 8 has been presented.|||44.9|-3.0|
70906877|NCT02564055|141303301|OTHER||Difference in percentages|10.9|||||TWO_SIDED|95.0|-13.5|34.7|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 8 has been presented.|||34.7|-13.5|
71151829|NCT02304367|141795802|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 192||||< 0.001
71151830|NCT02304367|141795802|OTHER|||||||0.174|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 216||||0.174
71151831|NCT02304367|141795802|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 240||||< 0.001
71151832|NCT02304367|141795803|OTHER|||||||0.694|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 24||||0.694
71151833|NCT02304367|141795803|OTHER|||||||0.047|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 48||||0.047
71151834|NCT02304367|141795803|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 96||||< 0.001
71151835|NCT02304367|141795803|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 144||||< 0.001
70906878|NCT02564055|141303301|OTHER||Difference in percentages|27.4|||||TWO_SIDED|95.0|2.5|49.9|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 12 has been presented.|||49.9|2.5|
70906879|NCT02564055|141303301|OTHER||Difference in percentages|16.8|||||TWO_SIDED|95.0|-9.0|40.7|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 12 has been presented.|||40.7|-9.0|
70906880|NCT02564055|141303301|OTHER||Difference in percentages|29.5|||||TWO_SIDED|95.0|3.7|52.3|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 12 has been presented.|||52.3|3.7|
70906881|NCT02564055|141303301|OTHER||Difference in percentages|5.7|||||TWO_SIDED|95.0|-20.1|30.9|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 12 has been presented.|||30.9|-20.1|
70906882|NCT02564055|141303301|OTHER||Difference in percentages|9.3|||||TWO_SIDED|95.0|-16.2|33.8|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 14 has been presented.|||33.8|-16.2|
70906883|NCT02564055|141303301|OTHER||Difference in percentages|12.6|||||TWO_SIDED|95.0|-13.4|37.3|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 14 has been presented.|||37.3|-13.4|
70906884|NCT02564055|141303301|OTHER||Difference in percentages|27.0|||||TWO_SIDED|95.0|0.7|50.5|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 14 has been presented.|||50.5|0.7|
70906885|NCT02564055|141303301|OTHER||Difference in percentages|0.4|||||TWO_SIDED|95.0|-25.6|25.6|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 14 has been presented.|||25.6|-25.6|
70906886|NCT02564055|141303301|OTHER||Difference in percentages|2.6|||||TWO_SIDED|95.0|-22.6|27.6|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 16 has been presented.|||27.6|-22.6|
71151836|NCT02304367|141795803|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 168||||< 0.001
70968429|NCT03670953|141442829|SUPERIORITY|2-sided at a significance level of alpha = 0.05|Least Squares Mean difference|0.53|STANDARD_ERROR_OF_MEAN|0.226||0.0194|TWO_SIDED|95.0|0.09|0.97||"LSM, SE, CI and p-value from a MMRM with CFB in Good on time as outcome, baseline Good on time as a covariate, treatment and visit as fixed effects, pooled center as random effect and a treatment-by-visit interaction."|MMRM|The degree-of-freedom of the denominator is estimated using the Kenward-Roger method. Unstructured covariance structure is assumed.||||0.97|0.09|0.0194
71090856|NCT02081807|141688005|OTHER||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.38|0.89|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||MarketScan-Apixaban vs. Warfarin (as reference group).||0.89|0.38|
71151837|NCT02304367|141795803|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 192||||< 0.001
71151838|NCT02304367|141795803|OTHER|||||||0.17|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 216||||0.170
71151839|NCT02304367|141795803|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 240||||< 0.001
71151840|NCT02304367|141795804|OTHER|||||||0.09|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 24||||0.090
71151841|NCT02304367|141795804|OTHER|||||||0.226|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 48||||0.226
71151842|NCT02304367|141795804|OTHER|||||||0.918|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 96||||0.918
71151843|NCT02304367|141795804|OTHER|||||||0.616|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 144||||0.616
71151844|NCT02304367|141795804|OTHER|||||||0.041|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 168||||0.041
71151845|NCT02304367|141795804|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 192||||0.002
71151846|NCT02304367|141795804|OTHER|||||||0.137|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 216||||0.137
71151847|NCT02304367|141795804|OTHER|||||||0.368|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 240||||0.368
71151848|NCT02304367|141795805|OTHER|||||||0.018|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 24||||0.018
71151849|NCT02304367|141795805|OTHER|||||||0.133|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 48||||0.133
71151850|NCT02304367|141795805|OTHER|||||||0.321|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 96||||0.321
71151851|NCT02304367|141795805|OTHER|||||||0.218|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 144||||0.218
71151852|NCT02304367|141795805|OTHER|||||||0.788|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 168||||0.788
71151853|NCT02304367|141795805|OTHER|||||||0.156|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 192||||0.156
71151854|NCT02304367|141795805|OTHER|||||||0.155|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 216||||0.155
71151855|NCT02304367|141795805|OTHER|||||||0.58|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 240||||0.580
71151856|NCT02304367|141795806|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 24||||0.002
71151857|NCT02304367|141795806|OTHER|||||||0.273|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 48||||0.273
71151858|NCT02304367|141795806|OTHER|||||||0.469|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 96||||0.469
71151859|NCT02304367|141795806|OTHER|||||||0.828|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 144||||0.828
71151860|NCT02304367|141795806|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 168||||< 0.001
71151861|NCT02304367|141795806|OTHER|||||||0.141|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 192||||0.141
71151862|NCT02304367|141795806|OTHER|||||||0.606|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 216||||0.606
71151863|NCT02304367|141795806|OTHER|||||||0.907|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 240||||0.907
71151864|NCT02304367|141795807|OTHER|||||||0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 24||||0.001
71151865|NCT02304367|141795807|OTHER|||||||0.149|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 48||||0.149
71151866|NCT02304367|141795807|OTHER|||||||0.372|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 96||||0.372
71151867|NCT02304367|141795807|OTHER|||||||0.116|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 144||||0.116
71151868|NCT02304367|141795807|OTHER|||||||0.013|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 168||||0.013
70906887|NCT02564055|141303301|OTHER||Difference in percentages|6.9|||||TWO_SIDED|95.0|-18.7|31.7|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 16 has been presented.|||31.7|-18.7|
70906888|NCT02564055|141303301|OTHER||Difference in percentages|16.8|||||TWO_SIDED|95.0|-9.5|41.4|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 16 has been presented.|||41.4|-9.5|
70906889|NCT02564055|141303301|OTHER||Difference in percentages|10.9|||||TWO_SIDED|95.0|-14.9|35.8|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 16 has been presented.|||35.8|-14.9|
70906890|NCT02564055|141303301|OTHER||Difference in percentages|33.3|||||TWO_SIDED|95.0|-31.9|90.6|||||Difference between GSK2894512 1 % BID and Vehicle BID at EW has been presented.|||90.6|-31.9|
70906891|NCT02564055|141303301|OTHER||Difference in percentages|-9.1|||||TWO_SIDED|95.0|-62.4|47.8|||||Difference between GSK2894512 1 % QD and Vehicle QD at EW has been presented.|||47.8|-62.4|
70906892|NCT02564055|141303301|OTHER||Difference in percentages|14.3|||||TWO_SIDED|95.0|-32.2|57.9|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at EW has been presented.|||57.9|-32.2|
71151869|NCT02304367|141795807|OTHER|||||||0.962|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 192||||0.962
70906893|NCT02564055|141303301|OTHER||Difference in percentages|24.2|||||TWO_SIDED|95.0|-40.3|80.9|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at EW has been presented.|||80.9|-40.3|
70906894|NCT02564055|141303308|OTHER||Difference in percentages|-7.7|||||TWO_SIDED|95.0|-45.8|32.5|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 1 has been presented.|||32.5|-45.8|
70906895|NCT02564055|141303308|OTHER||Difference in percentages|15.4|||||TWO_SIDED|95.0|-25.7|52.6|||||Difference between GSK2894512 1 % QD and vehicle QD at Week 1 has been presented.|||52.6|-25.7|
70968430|NCT03670953|141442830|SUPERIORITY|2-sided at a significance level of alpha = 0.05|Least Squares Mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.214||0.0252|TWO_SIDED|95.0|-0.9|-0.06||"LSM, SE, CI and p-value from a MMRM with CFB in Off time as outcome, baseline Off time as a covariate, treatment and visit as fixed effects, pooled center as random effect and a treatment-by-visit interaction."|MMRM|The degree-of-freedom of the denominator is estimated using the Kenward-Roger method. Unstructured covariance structure is assumed.||||-0.06|-0.90|0.0252
71090857|NCT02081807|141688005|OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.5|0.96|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.96|0.50|
71151870|NCT02304367|141795807|OTHER|||||||0.664|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 216||||0.664
71151871|NCT02304367|141795807|OTHER|||||||0.79|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 240||||0.790
71151872|NCT02304367|141795808|OTHER|||||||0.05|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 24||||0.050
70906896|NCT02564055|141303308|OTHER||Difference in percentages|-7.7|||||TWO_SIDED|95.0|-46.0|32.6|||||Difference between GSK2894512 0.5 % BID and vehicle BID at Week 1 has been presented.|||32.6|-46.0|
70906897|NCT02564055|141303308|OTHER||Difference in percentages|9.1|||||TWO_SIDED|95.0|-32.2|48.8|||||Difference between GSK2894512 0.5 % QD and vehicle QD at Week 1 has been presented.|||48.8|-32.2|
70906898|NCT02564055|141303308|OTHER||Difference in percentages|-24.2|||||TWO_SIDED|95.0|-60.8|14.8|||||Difference between GSK2894512 1 % BID and vehicle BID at Week 2 has been presented.|||14.8|-60.8|
70906899|NCT02564055|141303308|OTHER||Difference in percentages|28.5|||||TWO_SIDED|95.0|-13.7|63.0|||||Difference between GSK2894512 1 % QD and vehicle QD at Week 2 has been presented.|||63.0|-13.7|
70906900|NCT02564055|141303308|OTHER||Difference in percentages|-33.3|||||TWO_SIDED|95.0|-67.4|6.1|||||Difference between GSK2894512 0.5 % BID and vehicle BID at Week 2 has been presented.|||6.1|-67.4|
70968431|NCT03670953|141442831|SUPERIORITY|2-sided at a significance level of alpha = 0.05|Percent difference|10.9||||0.0015|TWO_SIDED|95.0|3.5|18.3||"P-value from the Cochran-Mantel-Haenszel test stratified by pooled center comparing the percentage of Much or Very Much Improved participants between the treatment groups."|Cochran-Mantel-Haenszel|||||18.3|3.5|0.0015
71151873|NCT02304367|141795808|OTHER|||||||0.526|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 48||||0.526
71151874|NCT02304367|141795808|OTHER|||||||0.845|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 96||||0.845
71151875|NCT02304367|141795808|OTHER|||||||0.782|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 144||||0.782
70906901|NCT02564055|141303308|OTHER||Difference in percentages|-0.9|||||TWO_SIDED|95.0|-40.7|40.7|||||Difference between GSK2894512 0.5 % QD and vehicle QD at Week 2 has been presented.|||40.7|-40.7|
70906902|NCT02564055|141303308|OTHER||Difference in percentages|-15.2|||||TWO_SIDED|95.0|-53.8|23.5|||||Difference between GSK2894512 1 % BID and vehicle BID at Week 4 has been presented.|||23.5|-53.8|
70906903|NCT02564055|141303308|OTHER||Difference in percentages|43.4|||||TWO_SIDED|95.0|2.7|74.6|||||Difference between GSK2894512 1 % QD and vehicle QD at Week 4 has been presented.|||74.6|2.7|
70906904|NCT02564055|141303308|OTHER||Difference in percentages|-15.2|||||TWO_SIDED|95.0|-53.8|23.5|||||Difference between GSK2894512 0.5 % BID and vehicle BID at Week 4 has been presented.|||23.5|-53.8|
70906905|NCT02564055|141303308|OTHER||Difference in percentages|9.1|||||TWO_SIDED|95.0|-35.6|51.2|||||Difference between GSK2894512 0.5 % QD and vehicle QD at Week 4 has been presented.|||51.2|-35.6|
70906906|NCT02564055|141303308|OTHER||Difference in percentages|18.3|||||TWO_SIDED|95.0|-25.1|57.1|||||Difference between GSK2894512 1 % BID and vehicle BID at Week 8 has been presented.|||57.1|-25.1|
70906907|NCT02564055|141303308|OTHER||Difference in percentages|47.7|||||TWO_SIDED|95.0|4.8|78.7|||||Difference between GSK2894512 1 % QD and vehicle QD at Week 8 has been presented.|||78.7|4.8|
70906908|NCT02564055|141303308|OTHER||Difference in percentages|-11.7|||||TWO_SIDED|95.0|-51.3|30.2|||||Difference between GSK2894512 0.5 % BID and vehicle BID at Week 8 has been presented.|||30.2|-51.3|
70906909|NCT02564055|141303308|OTHER||Difference in percentages|9.1|||||TWO_SIDED|95.0|-35.6|51.2|||||Difference between GSK2894512 0.5 % QD and vehicle QD at Week 8 has been presented.|||51.2|-35.6|
70906910|NCT02564055|141303308|OTHER||Difference in percentages|6.4|||||TWO_SIDED|95.0|-35.4|48.5|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 12 has been presented.|||48.5|-35.4|
70906911|NCT02564055|141303308|OTHER||Difference in percentages|6.0|||||TWO_SIDED|95.0|-35.8|47.1|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 12 has been presented.|||47.1|-35.8|
70906912|NCT02564055|141303308|OTHER||Difference in percentages|-13.6|||||TWO_SIDED|95.0|-54.0|31.2|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 12 has been presented.|||31.2|-54.0|
70906913|NCT02564055|141303308|OTHER||Difference in percentages|-25.6|||||TWO_SIDED|95.0|-65.3|22.4|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 12 has been presented.|||22.4|-65.3|
70906914|NCT02564055|141303308|OTHER||Difference in percentages|-1.0|||||TWO_SIDED|95.0|-44.5|42.7|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 14 has been presented.|||42.7|-44.5|
70906915|NCT02564055|141303308|OTHER||Difference in percentages|5.6|||||TWO_SIDED|95.0|-37.8|47.3|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 14 has been presented.|||47.3|-37.8|
70906916|NCT02564055|141303308|OTHER||Difference in percentages|-5.5|||||TWO_SIDED|95.0|-47.9|37.6|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 14 has been presented.|||37.6|-47.9|
70906917|NCT02564055|141303308|OTHER||Difference in percentages|-4.4|||||TWO_SIDED|95.0|-48.3|41.5|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 14 has been presented.|||41.5|-48.3|
70906918|NCT02564055|141303308|OTHER||Difference in percentages|-1.0|||||TWO_SIDED|95.0|-44.5|42.7|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 16 has been presented.|||42.7|-44.5|
70906919|NCT02564055|141303308|OTHER||Difference in percentages|8.3|||||TWO_SIDED|95.0|-35.0|49.2|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 16 has been presented.|||49.2|-35.0|
70906920|NCT02564055|141303308|OTHER||Difference in percentages|-3.3|||||TWO_SIDED|95.0|-46.0|42.3|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 16 has been presented.|||42.3|-46.0|
70906921|NCT03268590|141303357|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.05
71090858|NCT02081807|141688006|OTHER||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.38|0.69|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.69|0.38|
71090859|NCT02081807|141688006|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.68|0.86|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||MarketScan-Dabigatran vs. Warfarin (as reference group).||0.86|0.68|
71151876|NCT02304367|141795808|OTHER|||||||0.02|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 168||||0.020
70906922|NCT03268590|141303358|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.05
70906923|NCT03268590|141303359|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.05
70906924|NCT02971891|141303363|SUPERIORITY|||||||0.1789|||||||Cochran-Mantel-Haenszel|||||||0.1789
70906925|NCT00919893|141303385|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||t-test, 2 sided|||"Null hypothesis: Cernilton compared to placebo induces a better or the same outcome of symptomatic improvement in the pain domain of symptomatic Pelvic Pain Syndrome verified by the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI).~Power calculation: A power of 1-beta=0.8 was calculated."||||<0.05
70906926|NCT02524054|141303411|SUPERIORITY|||||||0.35||||||The p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||This is a paired t-test comparing the treatment effect of furosemide to the treatment effect of saline in each individual.||||0.35
70906927|NCT02524054|141303412|SUPERIORITY||||||<|0.001||||||The p-value is not adjusted for multiple comparisons, and the a priori threshold for significance was 0.05.|t-test, 2 sided|||||||<0.001
71151877|NCT02304367|141795808|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 192||||0.005
70906928|NCT03537261|141303413|SUPERIORITY||Mean Difference (Net)|5.8||||0.11|TWO_SIDED|95.0|-1.4|13.1|||Regression, Linear|Repeated measures linear regression controlling for score at screening visit|(P-CPI training change) - (waitlist change)|||13.1|-1.4|0.11
70906929|NCT03537261|141303414|SUPERIORITY||Mean Difference (Net)|-2.2||||0.4|TWO_SIDED|95.0|-7.4|3.0|||Regression, Linear|Repeated measures linear regression controlling for score at screening visit|(P-CPI training change) - (waitlist change)|||3.0|-7.4|0.40
70906930|NCT03537261|141303415|SUPERIORITY||Mean Difference (Net)|0.6||||0.72|TWO_SIDED|95.0|-2.9|4.2|||Regression, Linear|Repeated measures linear regression controlling for score at screening visit|(P-CPI training change) - (waitlist change)|||4.2|-2.9|0.72
70906931|NCT02500979|141303510|SUPERIORITY_OR_OTHER||Least squares mean difference|-21.5|STANDARD_ERROR_OF_MEAN|7.88||0.0118|TWO_SIDED|95.0|-37.8|-5.2|||Linear mixed-effects model|||||-5.2|-37.8|0.0118
70906932|NCT02500979|141303511|SUPERIORITY_OR_OTHER||LS mean difference (pramlintide-placebo)|-7.897||||0.0013|TWO_SIDED|95.0|-12.356|-3.438|||Linear mixed effects model|||||-3.438|-12.356|0.0013
70906933|NCT02500979|141303512|SUPERIORITY_OR_OTHER||LS mean difference (pramlintide-placebo)|-5.277||||0.0091|TWO_SIDED|95.0|-9.175|-1.378|||Linear mixed effects model|||||-1.378|-9.175|0.0091
70906934|NCT02500979|141303513|SUPERIORITY_OR_OTHER||LS mean difference (pramlintide-placebo)|-4.435||||0.0057|TWO_SIDED|95.0|-7.445|-1.424|||Linear mixed effects model|||||-1.424|-7.445|0.0057
70906935|NCT02500979|141303514|SUPERIORITY_OR_OTHER||Least squares mean difference|-28733.0|STANDARD_ERROR_OF_MEAN|4163.6|<|0.0001|TWO_SIDED|95.0|-37326.0|-20139.0|||Linear mixed-effects model|||||-20139|-37326|<0.0001
70906936|NCT02500979|141303515|SUPERIORITY_OR_OTHER||LS mean difference|-28.418||||0.0258|TWO_SIDED|95.0|-53.099|-3.737|||Linear mixed-effects model|||||-3.737|-53.099|0.0258
70906937|NCT02500979|141303517|SUPERIORITY_OR_OTHER||LS Mean Ratio (Pramlintide/Placebo)|1.31||||0.0456|TWO_SIDED|95.0|1.01|1.7|||Linear mixed-effects model|||||1.70|1.01|0.0456
70906938|NCT02500979|141303518|SUPERIORITY_OR_OTHER||LS mean ratio (pramlintide/placebo)|0.951||||0.1015|TWO_SIDED|95.0|0.896|1.011|||Linear mixed-effects model|||||1.011|0.896|0.1015
70906939|NCT02500979|141303520|SUPERIORITY_OR_OTHER||LS mean ratio (pramlintide/placebo)|1.085||||0.373|TWO_SIDED|95.0|0.901|1.307|||Linear mixed effects model|||||1.307|0.901|0.3730
71151878|NCT02304367|141795808|OTHER|||||||0.136|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 216||||0.136
70906940|NCT00267111|141303533|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||Statistical analyses were performed using SPSS v12, USA). Pain scores were compared between groups by means of the Student t-test. A p-value of \< 0.05 was considered significant.|t-test, 2 sided|||We hypothesized that topical amethocaine gel 4% would reduce the pain from IM injection. The sample size was based on the pain scores obtained from a previous study that compared pain response during IM injection. To achieve a clinically significant reduction in pain scores by 20% between groups with 80% power and an alpha value of \< 0.05, we estimated sample size of 49 neonates in each group. A total of 110 neonates were enrolled to account for possible dropouts and missing data.||||< 0.05
70906941|NCT00267111|141303534|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||Statistical analyses were performed using SPSS v12, USA). Pain scores were compared between groups by means of the Student t-test. A p-value of \< 0.05 was considered significant|t-test, 2 sided|||We hypothesized that parents and nurses will report lower pain scores as assessed by visual analogue scale in topical amethocaine gel 4% compared to placebo group. This was a secondary outcome and no power calculation was performed.||||<0.05
70906942|NCT02368002|141303541|SUPERIORITY|||||||0.25||||||2 df re-random\*time interaction tested if baseline to 6M or 18M PCM and ABT weight changes differed; primary hypothesis tests were 2 planned contrasts estimating baseline to 6M (H1a, expected neg) and 18M (H1b, expected pos) PCM vs. ABT weight change|Mixed Models Analysis|The mixed model included a random participant intercept. Fixed covariates were baseline weight, TRA timing, sex, weight loss rate.||H1 predicted that suboptimal responders re-randomized to PCM would lose more weight at 6m (H1a) while those re-randomized to ABT would lose more weight at 18m (H1b). A mixed linear model predicted weight change from fixed re-randomization, measurement time, the re-randomization by measurement time interaction and covariate parameters.|The primary hypothesis tests were two planned contrasts that estimated weight change from baseline to 6M and 18M relative to baseline in PCM relative to ABT. A mixed linear model predicted weight changes between baseline and post-baseline for suboptimal responders, and this model included two a priori simple effects tests resulting in two mean differences, confidence intervals, and p-values. H1a: -2.7 lbs; 95% CI: -5.8, 0.5; p=0.09. H1b: -1.0 lbs; 95% CI: -4.2, 2.2; p=0.53|||0.25
70906943|NCT02368002|141303542|SUPERIORITY||Mean Difference (Net)|-0.1||||0.96|TWO_SIDED|95.0|-2.4|2.3|||Mixed Models Analysis|The mixed model included a random participant intercept. Fixed covariates were baseline weight, sex, TRA result (PCM, ABT, responder, pre-TRA quit).||Hypothesis 2 predicted that among all participants, those randomized to Early TRA would lose more weight at 6 and 18 months than those randomized to Late TRA. A mixed linear model predicted weight change from fixed treatment response assessment timing and covariate parameters.||2.3|-2.4|0.96
70906944|NCT00579982|141303557|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Paired t-test|t-test, 2 sided|||||||<0.001
70906945|NCT05199233|141303573|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|The mean change from baseline was compared to zero using a one-sample t-test.||||||<0.001
70906946|NCT05199233|141303574|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|The mean change from baseline was compared to zero using a one-sample t-test.||||||<0.001
70906947|NCT02471404|141303590|NON_INFERIORITY|The non-inferiority (NI) margin was determined to be 0.30% (in absolute terms). A difference of ≤0.30%, in HbA1c change from b/l to wk 52 between the treatment groups was considered clinically equivalent. NI was assessed using the 2-sided 95% CI of adjusted mean difference between dapagliflozin or dapagliflozin plus saxagliptin and glimepiride.|Mean Difference (Final Values)|0.16|||||TWO_SIDED|95.0|0.0294|0.2986|||Mixed Models Analysis|||||0.2986|0.0294|
70906948|NCT02471404|141303590|NON_INFERIORITY|The non-inferiority (NI) margin was determined to be 0.30% (in absolute terms). A difference of ≤0.30%, in HbA1c change from b/l to wk 52 between the treatment groups was considered clinically equivalent. NI was assessed using the 2-sided 95% Confidence Interval of adjusted mean difference between dapagliflozin or dapagliflozin plus saxagliptin and glimepiride.|Mean Difference (Final Values)|-0.21||||0.001|TWO_SIDED|95.0|-0.3443|-0.0825||(superiority)|Mixed Models Analysis|||||-0.0825|-0.3443|0.001
70906949|NCT02471404|141303591|SUPERIORITY||Risk Difference (RD)|-4.21|STANDARD_ERROR_OF_MEAN|1.14|<|0.001|TWO_SIDED|95.0|-6.45|-1.97|||Fisher Exact|||||-1.97|-6.45|<0.001
70906950|NCT02471404|141303591|SUPERIORITY||Risk Difference (RD)|-3.89|STANDARD_ERROR_OF_MEAN|1.19|<|0.001|TWO_SIDED|95.0|-6.21|-1.56|||Fisher Exact|||||-1.56|-6.21|<0.001
70906951|NCT02471404|141303592|SUPERIORITY||Mean Difference (Final Values)|-5.3|||<|0.001|TWO_SIDED|95.0|-5.93|-4.67|||Mixed Models Analysis|||||-4.67|-5.93|<0.001
71151879|NCT02304367|141795808|OTHER|||||||0.101|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 240||||0.101
71151880|NCT02304367|141795809|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 24||||< 0.001
70906952|NCT02471404|141303592|SUPERIORITY||Mean Difference (Final Values)|-4.91|||<|0.001|TWO_SIDED|95.0|-5.52|-4.29|||Mixed Models Analysis|||||-4.29|-5.52|<0.001
71090860|NCT02081807|141688006|OTHER||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.65|0.8|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.80|0.65|
70906953|NCT02471404|141303593|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.374|TWO_SIDED|95.0|-0.43|0.16|||Mixed Models Analysis|||||0.16|-0.43|0.374
71151881|NCT02304367|141795809|OTHER|||||||0.238|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 48||||0.238
70906954|NCT02471404|141303593|SUPERIORITY||Mean Difference (Final Values)|-0.59|||<|0.001|TWO_SIDED|95.0|-0.88|-0.31|||Mixed Models Analysis|||||-0.31|-0.88|<0.001
71151882|NCT02304367|141795809|OTHER|||||||0.286|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 96||||0.286
70906955|NCT02471404|141303594|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.777|TWO_SIDED|95.0|0.67|1.35|||Regression, Cox|||||1.35|0.67|0.777
71151883|NCT02304367|141795809|OTHER|||||||0.093|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 144||||0.093
71151884|NCT02304367|141795809|OTHER|||||||0.89|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 168||||0.890
70906956|NCT02471404|141303594|SUPERIORITY||Hazard Ratio (HR)|0.36|||<|0.001|TWO_SIDED|95.0|0.23|0.57|||Regression, Cox|||||0.57|0.23|<0.001
70906957|NCT02144519|141303601|SUPERIORITY||Odds Ratio (OR)|1.88||||0.008|TWO_SIDED|95.0|1.18|3.0|||Mixed Models Analysis|||||3.00|1.18|0.008
70906958|NCT02144519|141303602|SUPERIORITY||Odds Ratio (OR)|3.8||||0.003|TWO_SIDED|95.0|1.45|9.95|||Regression, Logistic|||||9.95|1.45|0.003
71151885|NCT02304367|141795809|OTHER|||||||0.059|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 192||||0.059
71151886|NCT02304367|141795809|SUPERIORITY|||||||0.623||||||Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.|GEE model|||Week 216||||0.623
71151887|NCT02304367|141795809|OTHER|||||||0.411|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 240||||0.411
71151888|NCT02304367|141795810|OTHER|||||||0.8209|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.8209
71151889|NCT02304367|141795810|OTHER|||||||0.2851|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.2851
71151890|NCT02304367|141795810|OTHER|||||||0.6689|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.6689
71151891|NCT02304367|141795810|OTHER|||||||0.1612|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.1612
71151892|NCT02304367|141795811|OTHER|||||||0.4093|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.4093
71151893|NCT02304367|141795811|OTHER|||||||0.572|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.5720
71151894|NCT02304367|141795811|OTHER|||||||0.3501|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.3501
71090861|NCT02081807|141688006|OTHER||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.88|1.26|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.26|0.88|
71151895|NCT02304367|141795811|OTHER|||||||0.5172|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.5172
71151896|NCT02304367|141795812|OTHER|||||||0.0046|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline STS measurement.||Week 24||||0.0046
71151897|NCT02304367|141795812|OTHER|||||||0.0012|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline STS measurement.||Week 48||||0.0012
71151898|NCT02304367|141795813|OTHER|||||||0.6475|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.6475
71151899|NCT02304367|141795813|OTHER|||||||0.5319|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.5319
71151900|NCT02304367|141795813|OTHER|||||||0.9206|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.9206
71151901|NCT02304367|141795813|OTHER|||||||0.153|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.1530
70906959|NCT00305864|141303604|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Log Rank|One-sided||A one-sided one-sample log-rank test at significance level of 0.10 was predicted to have 85% power to detect a survival difference against the historical control (13.7 vs. 18.5 months) with 60 deaths.||||0.27
70906960|NCT03881059|141303616|SUPERIORITY||Slope Coefficient of Dose|0.11|||<|0.001|TWO_SIDED|95.0|0.05|0.17|||Regression, Logistic|||||0.17|0.05|<0.001
70906961|NCT02942004|141303697|SUPERIORITY||Least Square (LS) Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|1.664||0.0013|TWO_SIDED|95.0|-8.8|-2.2|||MMRM|||Mixed effect model for repeated measures (MMRM) was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-2.20|-8.80|0.0013
71090862|NCT02081807|141688006|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.92|1.12|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||MarketScan-Rivaroxaban vs. Warfarin (as reference group).||1.12|0.92|
71151902|NCT02304367|141795814|OTHER|||||||0.2125|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.2125
71151903|NCT02304367|141795814|OTHER|||||||0.1241|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.1241
71151904|NCT02304367|141795815|OTHER|||||||0.41|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.410
71151905|NCT02304367|141795815|OTHER|||||||0.21|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.210
71151906|NCT02304367|141795815|OTHER|||||||0.06|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.060
71151907|NCT02304367|141795815|OTHER|||||||0.076|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.076
71151908|NCT02304367|141795815|OTHER|||||||0.171|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.171
71151909|NCT02304367|141795815|OTHER|||||||0.141|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.141
70906962|NCT02942004|141303697|SUPERIORITY||LS mean difference|-3.68|STANDARD_ERROR_OF_MEAN|1.622||0.0252|TWO_SIDED|95.0|-6.9|-0.47|||MMRM|||MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.47|-6.90|0.0252
70906963|NCT02942004|141303698|SUPERIORITY||LS mean difference|-5.63|STANDARD_ERROR_OF_MEAN|1.936||0.0044|TWO_SIDED|95.0|-9.46|-1.79|||MMRM|||MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.79|-9.46|0.0044
71090863|NCT02081807|141688006|OTHER||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.94|1.12|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.12|0.94|
71151910|NCT02304367|141795815|OTHER|||||||0.263|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.263
71151911|NCT02304367|141795815|OTHER|||||||0.32|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.320
71151912|NCT02304367|141795816|OTHER|||||||0.407|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.407
71151913|NCT02304367|141795816|OTHER|||||||0.192|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.192
71151914|NCT02304367|141795816|OTHER|||||||0.106|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.106
71151915|NCT02304367|141795816|OTHER|||||||0.02|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.020
71151916|NCT02304367|141795816|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.002
71151917|NCT02304367|141795816|OTHER|||||||0.22|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.220
71151918|NCT02304367|141795816|OTHER|||||||0.23|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.230
70906964|NCT02942004|141303698|SUPERIORITY||LS mean difference|-3.79|STANDARD_ERROR_OF_MEAN|1.899||0.0481|TWO_SIDED|95.0|-7.56|-0.03|||MMRM|||MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-7.56|0.0481
71151919|NCT02304367|141795816|OTHER|||||||0.232|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.232
71151920|NCT02304367|141795817|OTHER|||||||0.082|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.082
71151921|NCT02304367|141795817|OTHER|||||||0.176|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.176
71151922|NCT02304367|141795817|OTHER|||||||0.047|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.047
71151923|NCT02304367|141795817|OTHER|||||||0.017|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.017
71008425|NCT03018028|141524710|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.15||||0.0005|TWO_SIDED|95.0|0.05|0.44||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 7 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.44|0.05|0.0005
71151924|NCT02304367|141795817|OTHER|||||||0|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.000
71151925|NCT02304367|141795817|OTHER|||||||0.057|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.057
71151926|NCT02304367|141795817|OTHER|||||||0.071|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.071
71151927|NCT02304367|141795817|OTHER|||||||0.07|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.070
71151928|NCT02304367|141795818|OTHER|||||||0.014|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.014
71151929|NCT02304367|141795818|OTHER|||||||0.309|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.309
71151930|NCT02304367|141795818|OTHER|||||||0.036|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.036
71151931|NCT02304367|141795818|OTHER|||||||0.096|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.096
71151932|NCT02304367|141795818|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.005
70906965|NCT02942004|141303699|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.951||0.9591|TWO_SIDED|95.0|-1.83|1.93|||MMRM|||Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.93|-1.83|0.9591
70906966|NCT02942004|141303699|SUPERIORITY||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.917||0.8677|TWO_SIDED|95.0|-1.66|1.97|||MMRM|||Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.97|-1.66|0.8677
70906967|NCT02942004|141303699|SUPERIORITY||LS mean difference|-2.11|STANDARD_ERROR_OF_MEAN|1.208||0.0827|TWO_SIDED|95.0|-4.51|0.28|||MMRM|||Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-4.51|0.0827
70906968|NCT02942004|141303699|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|1.172||0.7968|TWO_SIDED|95.0|-2.62|2.02|||MMRM|||Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.02|-2.62|0.7968
70906969|NCT02942004|141303699|SUPERIORITY||LS mean difference|-2.04|STANDARD_ERROR_OF_MEAN|1.336||0.1292|TWO_SIDED|95.0|-4.69|0.61|||MMRM|||Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.61|-4.69|0.1292
70906970|NCT02942004|141303699|SUPERIORITY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|1.299||0.7801|TWO_SIDED|95.0|-2.94|2.21|||MMRM|||Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.21|-2.94|0.7801
70906971|NCT02942004|141303699|SUPERIORITY||LS mean difference|-1.25|STANDARD_ERROR_OF_MEAN|1.436||0.384|TWO_SIDED|95.0|-4.1|1.59|||MMRM|||Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.59|-4.10|0.3840
70906972|NCT02942004|141303699|SUPERIORITY||LS mean difference|0.71|STANDARD_ERROR_OF_MEAN|1.395||0.6097|TWO_SIDED|0.71|-2.05|3.48|||MMRM|||Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||3.48|-2.05|0.6097
70906973|NCT02942004|141303699|SUPERIORITY||LS mean difference|-4.28|STANDARD_ERROR_OF_MEAN|1.622||0.0094|TWO_SIDED|95.0|-7.5|-1.07|||MMRM|||Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.07|-7.50|0.0094
70906974|NCT02942004|141303699|SUPERIORITY||LS mean difference|-2.32|STANDARD_ERROR_OF_MEAN|1.577||0.144|TWO_SIDED|95.0|-5.45|0.8|||MMRM|||Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.80|-5.45|0.1440
71090864|NCT02081807|141688006|OTHER||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.39|0.66|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.66|0.39|
71090865|NCT02081807|141688006|OTHER||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.49|0.68|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||MarketScan-Apixaban vs. Warfarin (as reference group).||0.68|0.49|
71090866|NCT02081807|141688006|OTHER||Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.49|0.64|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.64|0.49|
71090867|NCT02081807|141688007|OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.69|1.11|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||1.11|0.69|
71090868|NCT02081807|141688007|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.66|1.02|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.02|0.66|
70906975|NCT02942004|141303699|SUPERIORITY||LS mean difference|-5.12|STANDARD_ERROR_OF_MEAN|1.62||0.002|TWO_SIDED|95.0|-8.33|-1.91|||MMRM|||Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.91|-8.33|0.0020
70906976|NCT02942004|141303699|SUPERIORITY||LS mean difference|-1.36|STANDARD_ERROR_OF_MEAN|1.572||0.3906|TWO_SIDED|95.0|-4.47|1.76|||MMRM|||Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.76|-4.47|0.3906
70906977|NCT02942004|141303699|SUPERIORITY||LS mean difference|-4.49|STANDARD_ERROR_OF_MEAN|1.735||0.011|TWO_SIDED|95.0|-7.93|-1.05|||MMRM|||Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.05|-7.93|0.0110
70906978|NCT02942004|141303699|SUPERIORITY||LS mean difference|-3.33|STANDARD_ERROR_OF_MEAN|1.69||0.0511|TWO_SIDED|95.0|-6.68|0.02|||MMRM|||Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-6.68|0.0511
70906979|NCT02942004|141303699|SUPERIORITY||LS mean difference|-5.02|STANDARD_ERROR_OF_MEAN|1.738||0.0046|TWO_SIDED|95.0|-8.47|-1.58|||MMRM|||Change at hour 72: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.58|-8.47|0.0046
70906980|NCT02942004|141303699|SUPERIORITY||LS mean difference|-2.53|STANDARD_ERROR_OF_MEAN|1.694||0.1389|TWO_SIDED|95.0|-5.88|0.83|||MMRM|||Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.83|-5.88|0.1389
70906981|NCT02942004|141303699|SUPERIORITY||LS mean difference|-4.07|STANDARD_ERROR_OF_MEAN|1.837||0.0288|TWO_SIDED|95.0|-7.71|-0.43|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.43|-7.71|0.0288
71090869|NCT02081807|141688007|OTHER||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.47|0.88|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.88|0.47|
70906982|NCT02942004|141303699|SUPERIORITY||LS mean difference|-1.58|STANDARD_ERROR_OF_MEAN|1.797||0.3799|TWO_SIDED|95.0|-5.15|1.98|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.98|-5.15|0.3799
70906983|NCT02942004|141303699|SUPERIORITY||LS mean difference|-2.92|STANDARD_ERROR_OF_MEAN|2.139||0.1747|TWO_SIDED|95.0|-7.16|1.32|||MMRM|||Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.32|-7.16|0.1747
70906984|NCT02942004|141303699|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|2.08||0.631|TWO_SIDED|95.0|-5.13|3.12|||MMRM|||Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||3.12|-5.13|0.6310
70968432|NCT03670953|141442832|SUPERIORITY|2-sided at a significance level of alpha = 0.05|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.89||0.9587|TWO_SIDED|95.0|-1.8|1.7||LSM, SE, CI and p-value from a MMRM with CFB in MDS-UPDRS Part III Score as outcome, baseline MDS-UPDRS Part III Score as a covariate, treatment and visit as fixed effects, pooled center as random effect and a treatment-by-visit interaction.|MMRM|The degree-of-freedom of the denominator is estimated using the Kenward-Roger method. Unstructured covariance structure is assumed.||||1.7|-1.8|0.9587
71090870|NCT02081807|141688008|OTHER||Hazard Ratio (HR)|1.85|||||TWO_SIDED|95.0|1.03|3.3|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||3.30|1.03|
71090871|NCT02081807|141688008|OTHER||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.65|1.71|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.71|0.65|
70968433|NCT03670953|141442833|SUPERIORITY|2-sided at a significance level of alpha = 0.05|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.11||0.9668|TWO_SIDED|95.0|-2.2|2.1||LSM, SE, CI \& p-value from MMRM with CFB in MDS-UPDRS Part II \& III Scores as outcome, baseline MDS-UPDRS Part II and III Scores as a covariate, treatment and visit as fixed effects, pooled center as random effect \& a treatment-by-visit interaction.|MMRM|The degree-of-freedom of the denominator is estimated using the Kenward-Roger method. Unstructured covariance structure is assumed.||||2.1|-2.2|0.9668
70968434|NCT02603120|141442857|NON_INFERIORITY|A sample size of 260 participants per treatment group would provide at least 90% power to detect a noninferiority margin of 4% in difference in percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Wk 48, between B/F/TAF group and ABC/DTG/3TC group. Sample size was based on assumptions that both treatment groups have 2% of participants with HIV-1 RNA ≥ 50 copies/mL at Wk 48 and that the non-inferiority margin is 4%, and that the significance level of the test is at a one-sided 0.025 level.|Difference in Percentages|0.7|||||TWO_SIDED|95.002|-1.0|2.8|||||The differences in percentages of participants between treatment groups and their 95.002% CIs were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|||2.8|-1.0|
70968435|NCT02603120|141442857|SUPERIORITY|||||||0.62|||||||Fisher Exact|||||||0.62
70968436|NCT02603120|141442858|NON_INFERIORITY|It would be concluded that B/F/TAF is noninferior to ABC/DTG/3TC if the lower bound of the 2-sided 95.002% CI of the difference between treatment groups (B/F/TAF group -ABC/DTG/3TC group) in the percentage of participants with HIV-1 RNA \< 50 copies/mL is greater than -10%.|Difference in Percentages|-1.4|||||TWO_SIDED|95.002|-5.5|2.6|||||The differences in percentages of participants between treatment groups and their 95.002% CIs were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|||2.6|-5.5|
70968437|NCT02603120|141442858|SUPERIORITY|||||||0.59|||||||Fisher Exact|||||||.59
70968438|NCT02603120|141442859|OTHER||Difference in least squares means|-35.0||||0.031|TWO_SIDED|95.0|-67.0|-3.0|||ANOVA|||||-3|-67|0.031
71151933|NCT02304367|141795818|OTHER|||||||0.022|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.022
71151934|NCT02304367|141795818|OTHER|||||||0.022|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.022
70968439|NCT02603120|141442861|OTHER||Difference in least squares means|0.276||||0.33|TWO_SIDED|95.0|-0.275|0.827|||ANOVA|||||0.827|-0.275|0.33
71151935|NCT02304367|141795818|OTHER|||||||0.004|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.004
71151936|NCT02304367|141795819|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.005
71151937|NCT02304367|141795819|OTHER|||||||0.019|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.019
70968440|NCT02603120|141442863|OTHER||Difference in least squares means|-0.143||||0.47|TWO_SIDED|95.0|-0.534|0.248|||ANOVA|||||0.248|-0.534|0.47
70968441|NCT01761292|141442899|OTHER||mean|13.906|||<|0.0001|TWO_SIDED|95.0|11.5657|16.2466||The paired t-test or non-parametric signed rank test for 2 means (paired observations) (as is appropriate) was applied for testing the statistical significance of the Change From Baseline to End of Study. MFA% P \< 0.05 was set as significant.|t-test, 2 sided|||||16.2466|11.5657|<0.0001
70968442|NCT01761292|141442900|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||< 0.0001
70968443|NCT02495844|141442919|SUPERIORITY||Odds Ratio (OR)|4.14|||=|0.0679|TWO_SIDED|95.0|0.9|19.06|||Regression, Logistic|||||19.06|0.90|=0.0679
70968444|NCT02325219|141442932|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
70968445|NCT02325219|141442932|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
70968446|NCT02325219|141442933|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
70968447|NCT02325219|141442933|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
70968448|NCT00880399|141442987|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.4295|TWO_SIDED|95.0|-1.65|0.7|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 30 mg at Week 1||0.70|-1.65|0.4295
70968449|NCT00880399|141442987|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.15||||0.0586|TWO_SIDED|95.0|-2.34|0.04|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 60 mg at Week 1||0.04|-2.34|0.0586
70968450|NCT00880399|141442987|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.89||||0.0111|TWO_SIDED|95.0|-3.34|-0.43|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 30 mg at Week 2||-0.43|-3.34|0.0111
70968451|NCT00880399|141442987|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.84||||0.0141|TWO_SIDED|95.0|-3.3|-0.37|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 60 mg at Week 2||-0.37|-3.30|0.0141
70968452|NCT00880399|141442987|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.22||||0.0152|TWO_SIDED|95.0|-4.0|-0.43|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 30 mg at Week 4||-0.43|-4.00|0.0152
70968453|NCT00880399|141442987|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.06||||0.001|TWO_SIDED|95.0|-4.86|-1.25|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 60 mg at Week 4||-1.25|-4.86|0.0010
70968454|NCT00880399|141442987|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.41||||0.0245|TWO_SIDED|95.0|-4.5|-0.31|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 30 mg at Week 6||-0.31|-4.50|0.0245
70968455|NCT00880399|141442987|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.86||||0.0082|TWO_SIDED|95.0|-4.97|-0.75|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 60 mg at Week 6||-0.75|-4.97|0.0082
70968456|NCT00880399|141442989|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.51|TWO_SIDED|95.0|0.8|3.19|||Log Rank|||Placebo Vs Orvepitant 30 mg at Week 6||3.19|0.80|0.51
70968457|NCT00880399|141442989|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.66||||0.37|TWO_SIDED|95.0|0.84|3.3|||Log Rank|||Placebo Vs Orvepitant 60 mg at Week 6||3.30|0.84|0.37
71151938|NCT02304367|141795819|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||< 0.001
71151939|NCT02304367|141795819|OTHER|||||||0.006|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.006
71151940|NCT02304367|141795819|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||< 0.001
71151941|NCT02304367|141795819|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||< 0.001
71151942|NCT02304367|141795819|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.002
71151943|NCT02304367|141795819|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.002
71151944|NCT02304367|141795820|OTHER|||||||0.016|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.016
71151945|NCT02304367|141795820|OTHER|||||||0.004|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.004
71151946|NCT02304367|141795820|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||< 0.001
70968458|NCT00880399|141442990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.7859|TWO_SIDED|95.0|-0.72|0.55|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||0.55|-0.72|0.7859
70968459|NCT00880399|141442990|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.15||||0.6429|TWO_SIDED|95.0|-0.79|0.49|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||0.49|-0.79|0.6429
71090872|NCT02081807|141688008|OTHER||Hazard Ratio (HR)|0.31|||||TWO_SIDED|95.0|0.1|0.96|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.96|0.10|
71151947|NCT02304367|141795820|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||< 0.001
71151948|NCT02304367|141795820|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||< 0.001
71151949|NCT02304367|141795820|OTHER|||||||0.036|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.036
71151950|NCT02304367|141795820|OTHER|||||||0.008|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.008
70925893|NCT05794243|141345583|OTHER||Ratio of Geometric Least Squares Means|0.13|||||TWO_SIDED|90.0|0.0741|0.228|||Mixed Models Analysis|||AUC (0-∞) was log-transformed and analyzed via mixed model for repeated measures with fixed effects for treatment, profile day and the treatment-by-day interaction, and a random effect for participant. The least square means (LSMs) and differences in LSMs were back transformed to produce the ratio between geometric least square means (GLSMs).||0.228|0.0741|
70968460|NCT00880399|141442990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.04||||0.0092|TWO_SIDED|95.0|-1.82|-0.26|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||-0.26|-1.82|0.0092
70968461|NCT00880399|141442990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.91||||0.023|TWO_SIDED|95.0|-1.69|-0.13|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||-0.13|-1.69|0.0230
71090873|NCT02081807|141688009|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.63|1.12|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||1.12|0.63|
71151951|NCT02304367|141795820|OTHER|||||||0.008|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.008
71151952|NCT02304367|141795821|OTHER|||||||0.006|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.006
71151953|NCT02304367|141795821|OTHER|||||||0.003|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.003
71151954|NCT02304367|141795821|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||<0.001
70968462|NCT00880399|141442990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.29||||0.0104|TWO_SIDED|95.0|-2.27|-0.31|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||-0.31|-2.27|0.0104
70968463|NCT00880399|141442990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.68||||0.001|TWO_SIDED|95.0|-2.67|-0.69|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||-0.69|-2.67|0.0010
70968464|NCT00880399|141442990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.22||||0.0361|TWO_SIDED|95.0|-2.37|-0.08|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||-0.08|-2.37|0.0361
71151955|NCT02304367|141795821|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||< 0.001
71151956|NCT02304367|141795821|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||< 0.001
71151957|NCT02304367|141795821|SUPERIORITY|||||||0.007|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.007
71151958|NCT02304367|141795821|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.005
71151959|NCT02304367|141795821|OTHER|||||||0.006|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.006
71151960|NCT02304367|141795822|OTHER|||||||0.009|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.009
71151961|NCT02304367|141795822|OTHER|||||||0.02|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.020
71151962|NCT02304367|141795822|OTHER|||||||0.044|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.044
71151963|NCT02304367|141795822|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||< 0.001
71151964|NCT02304367|141795822|OTHER|||||||0.015|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.015
71151965|NCT02304367|141795822|OTHER|||||||0.125|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.125
71151966|NCT02304367|141795822|OTHER|||||||0.004|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.004
71151967|NCT02304367|141795822|OTHER|||||||0.018|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.018
71151968|NCT02304367|141795823|OTHER|||||||0.148|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.148
71151969|NCT02304367|141795823|OTHER|||||||0.295|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.295
71151970|NCT02304367|141795823|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.005
71151971|NCT02304367|141795823|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||< 0.001
71151972|NCT02304367|141795823|OTHER|||||||0.014|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.014
71151973|NCT02304367|141795823|OTHER|||||||0.14|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.140
71151974|NCT02304367|141795823|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||< 0.001
71151975|NCT02304367|141795823|OTHER|||||||0.142|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.142
71151976|NCT02304367|141795824|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.005
71151977|NCT02304367|141795824|OTHER|||||||0.077|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.077
71151978|NCT02304367|141795824|OTHER|||||||0.046|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.046
71151979|NCT02304367|141795824|OTHER|||||||0.049|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.049
71151980|NCT02304367|141795824|OTHER|||||||0.003|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.003
71151981|NCT02304367|141795824|OTHER|||||||0.073|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.073
70906985|NCT02942004|141303699|SUPERIORITY||LS mean difference|-4.92|STANDARD_ERROR_OF_MEAN|2.045||0.0178|TWO_SIDED|95.0|-8.98|-0.87|||MMRM|||Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.87|-8.98|0.0178
70968465|NCT00880399|141442990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.54||||0.0092||95.0|-2.69|-0.38|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.38|-2.69|0.0092
71090874|NCT02081807|141688009|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.57|0.96|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||0.96|0.57|
71151982|NCT02304367|141795824|OTHER|||||||0.109|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.109
71151983|NCT02304367|141795824|OTHER|||||||0.006|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.006
71151984|NCT02304367|141795825|OTHER|||||||0.328|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.328
71151985|NCT02304367|141795825|OTHER|||||||0.015|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.015
71151986|NCT02304367|141795825|OTHER|||||||0.02|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.020
71151987|NCT02304367|141795825|OTHER|||||||0.004|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.004
71151988|NCT02304367|141795825|OTHER|||||||0.021|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.021
71151989|NCT02304367|141795825|OTHER|||||||0.08|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.080
71151990|NCT02304367|141795825|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||< 0.001
71151991|NCT02304367|141795825|OTHER|||||||0.003|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.003
71151992|NCT02304367|141795826|OTHER|||||||0.207|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.207
71151993|NCT02304367|141795826|OTHER|||||||0.008|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.008
71151994|NCT02304367|141795826|OTHER|||||||0.598|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.598
71151995|NCT02304367|141795826|OTHER|||||||0.237|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.237
71151996|NCT02304367|141795826|OTHER|||||||0.899|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.899
71151997|NCT02304367|141795826|OTHER|||||||0.585|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.585
70968466|NCT00880399|141442991|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.72||||0.1662|TWO_SIDED|95.0|-1.74|0.3|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||0.30|-1.74|0.1662
70968467|NCT00880399|141442991|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.66||||0.2116|TWO_SIDED|95.0|-1.69|0.38|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||0.38|-1.69|0.2116
70968468|NCT00880399|141442991|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.02||||0.082|TWO_SIDED|95.0|-2.17|0.13|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||0.13|-2.17|0.0820
70968469|NCT00880399|141442991|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.55||||0.3498|TWO_SIDED|95.0|-1.71|0.61|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||0.61|-1.71|0.3498
70968470|NCT00880399|141442991|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.69||||0.0107|TWO_SIDED|95.0|-2.99|-0.4|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||-0.40|-2.99|0.0107
70968471|NCT00880399|141442991|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.1||||0.0017|TWO_SIDED|95.0|-3.4|-0.79|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||-0.79|-3.40|0.0017
71151998|NCT02304367|141795826|OTHER|||||||0.461|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.461
71151999|NCT02304367|141795826|OTHER|||||||0.583|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.583
71152000|NCT02304367|141795827|OTHER|||||||0.654|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.654
70906986|NCT02942004|141303699|SUPERIORITY||LS mean difference|-3.51|STANDARD_ERROR_OF_MEAN|1.976||0.0786|TWO_SIDED|95.0|-7.43|0.41|||MMRM|||Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.41|-7.43|0.0786
71152001|NCT02304367|141795827|OTHER|||||||0.579|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.579
70968472|NCT00880399|141442991|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.29||||0.088|TWO_SIDED|95.0|-2.78|0.19|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||0.19|-2.78|0.0880
70968473|NCT00880399|141442991|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.68||||0.0282|TWO_SIDED|95.0|-3.17|-0.18|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.18|-3.17|0.0282
70968474|NCT00880399|141442992|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.9854|TWO_SIDED|95.0|-0.45|0.44|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||0.44|-0.45|0.9854
70968475|NCT00880399|141442992|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21||||0.3476|TWO_SIDED|95.0|-0.66|0.23|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||0.23|-0.66|0.3476
70968476|NCT00880399|141442992|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.0898|TWO_SIDED|95.0|-0.94|0.07|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||0.07|-0.94|0.0898
70968477|NCT00880399|141442992|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.0928|TWO_SIDED|95.0|-0.95|0.07|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||0.07|-0.95|0.0928
70968478|NCT00880399|141442992|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32||||0.2937|TWO_SIDED|95.0|-0.93|0.28|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||0.28|-0.93|0.2937
70968479|NCT00880399|141442992|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59||||0.0587|TWO_SIDED|95.0|-1.2|0.02|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||0.02|-1.20|0.0587
70968480|NCT00880399|141442992|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.45||||0.195|TWO_SIDED|95.0|-1.14|0.23|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||0.23|-1.14|0.1950
71029522|NCT00090857|141567096|SUPERIORITY_OR_OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Sample size for a detectable difference in the within participant change in bone density between arms was calculated using standard deviations of one year change in bone density. Control estimates were 2.8% for spine and 3.85% for femoral neck. With 100 patients and 2:1 randomization (67 letrozole: 33 placebo), using a 1-sided Wilcoxon rank sum test with size 0.05, there is 80% power to detect as significant a true difference in change in the spine of 1.6% and in the femoral neck of 2.27%.||||0.70
71152002|NCT02304367|141795827|OTHER|||||||0.123|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.123
71152003|NCT02304367|141795827|OTHER|||||||0.712|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.712
71152004|NCT02304367|141795827|OTHER|||||||0.258|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.258
71152005|NCT02304367|141795827|OTHER|||||||0.851|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.851
71152006|NCT02304367|141795827|OTHER|||||||0.849|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.849
71152007|NCT02304367|141795827|OTHER|||||||0.153|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.153
70968481|NCT00880399|141442992|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.0498|TWO_SIDED|95.0|-1.4|0.0|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.00|-1.40|0.0498
70968482|NCT00880399|141442993|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.14||||0.1731|TWO_SIDED|95.0|0.72|6.4|||Regression, Logistic|||Placebo Vs Orvepitant 30 mg at Week 1||6.40|0.72|0.1731
70968483|NCT00880399|141442993|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.77||||0.7084|TWO_SIDED|95.0|0.2|2.97|||Regression, Logistic|||Placebo Vs Orvepitant 60 mg at Week 1||2.97|0.20|0.7084
71152008|NCT02304367|141795828|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.002
71152009|NCT02304367|141795828|OTHER|||||||0.03|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.030
71152010|NCT02304367|141795828|OTHER|||||||0.011|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.011
71152011|NCT02304367|141795828|OTHER|||||||0.186|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.186
71152012|NCT02304367|141795828|OTHER|||||||0.027|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.027
71152013|NCT02304367|141795828|OTHER|||||||0.33|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.330
70968484|NCT00880399|141442993|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.6||||0.0247|TWO_SIDED|95.0|1.13|5.98|||Regression, Logistic|||Placebo Vs Orvepitant 30 mg at Week 2||5.98|1.13|0.0247
70968485|NCT00880399|141442993|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.8||||0.1862|TWO_SIDED|95.0|0.75|4.3|||Regression, Logistic|||Placebo Vs Orvepitant 60 mg at Week 2||4.30|0.75|0.1862
71152014|NCT02304367|141795828|OTHER|||||||0.072|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.072
71152015|NCT02304367|141795828|OTHER|||||||0.045|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.045
71152016|NCT02304367|141795829|OTHER|||||||0.369|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.369
71152017|NCT02304367|141795829|OTHER|||||||0.026|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.026
71152018|NCT02304367|141795829|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||< 0.001
71152019|NCT02304367|141795829|OTHER|||||||0.235|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.235
70906987|NCT02942004|141303700|SUPERIORITY||Odds Ratio (OR)|5.4||||0.0052|TWO_SIDED|95.0|1.7|17.4|||GEE method|||Hour 60: Generalized estimating equation (GEE) method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||17.4|1.7|0.0052
70968486|NCT00880399|141442993|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.87||||0.063|TWO_SIDED|95.0|0.97|3.61|||Regression, Logistic|||Placebo Vs Orvepitant 30 mg at Week 4||3.61|0.97|0.0630
70968487|NCT00880399|141442993|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.65||||0.1413|TWO_SIDED|95.0|0.85|3.23|||Regression, Logistic|||Placebo Vs Orvepitant 60 mg at Week 4||3.23|0.85|0.1413
70968488|NCT00880399|141442993|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.77||||0.0806|TWO_SIDED|95.0|0.93|3.37|||Regression, Logistic|||Placebo Vs Orvepitant 30 mg at Week 6||3.37|0.93|0.0806
70968489|NCT00880399|141442993|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.53||||0.2007|TWO_SIDED|95.0|0.8|2.92|||Regression, Logistic|||Placebo Vs Orvepitant 60 mg at Week 6||2.92|0.80|0.2007
70968490|NCT00880399|141442994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.2523|TWO_SIDED|95.0|-0.25|0.07|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||0.07|-0.25|0.2523
70968491|NCT00880399|141442994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.2639|TWO_SIDED|95.0|-0.25|0.07|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||0.07|-0.25|0.2639
70968492|NCT00880399|141442994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.37||||0.0004|TWO_SIDED|95.0|-0.58|-0.17|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||-0.17|-0.58|0.0004
70968493|NCT00880399|141442994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.0348|TWO_SIDED|95.0|-0.43|-0.02|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||-0.02|-0.43|0.0348
70968494|NCT00880399|141442994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34||||0.0166|TWO_SIDED|95.0|-0.62|-0.06|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||-0.06|-0.62|0.0166
70968495|NCT00880399|141442994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.46||||0.0014|TWO_SIDED|95.0|-0.75|-0.18|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||-0.18|-0.75|0.0014
71152020|NCT02304367|141795829|OTHER|||||||0.009|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.009
71152021|NCT02304367|141795829|OTHER|||||||0.278|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.278
71152022|NCT02304367|141795829|OTHER|||||||0.046|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.046
71152023|NCT02304367|141795829|OTHER|||||||0.035|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.035
71152024|NCT02304367|141795830|OTHER|||||||0.442|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.442
71152025|NCT02304367|141795830|OTHER|||||||0.677|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.677
71152026|NCT02304367|141795830|OTHER|||||||0.027|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.027
70968496|NCT00880399|141442994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.45||||0.0099|TWO_SIDED|95.0|-0.79|-0.11|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||-0.11|-0.79|0.0099
70968497|NCT00880399|141442994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49||||0.0059|TWO_SIDED|95.0|-0.83|-0.14|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.14|-0.83|0.0059
70968498|NCT00880399|141442995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48||||0.5473|TWO_SIDED|95.0|-2.04|1.08|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||1.08|-2.04|0.5473
71029523|NCT00090857|141567097|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Sample size for a detectable difference in the within participant change in bone density between arms was calculated using standard deviations of one year change in bone density. Control estimates were 2.8% for spine and 3.85% for femoral neck. With 100 patients and 2:1 randomization (67 letrozole: 33 placebo), using a 1-sided Wilcoxon rank sum test with size 0.05, there is 80% power to detect as significant a true difference in change in the spine of 1.6% and in the femoral neck of 2.27%.||||0.03
71152027|NCT02304367|141795830|OTHER|||||||0.42|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.420
70968499|NCT00880399|141442995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.9814|TWO_SIDED|95.0|-1.56|1.6|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||1.60|-1.56|0.9814
70968500|NCT00880399|141442995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.51||||0.0515|TWO_SIDED|95.0|-3.03|0.01|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||0.01|-3.03|0.0515
70968501|NCT00880399|141442995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56||||0.468|TWO_SIDED|95.0|-2.09|0.96|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||0.96|-2.09|0.4680
70968502|NCT00880399|141442995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.22||||0.1757|TWO_SIDED|95.0|-2.98|0.55|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||0.55|-2.98|0.1757
70968503|NCT00880399|141442995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.15||||0.2048|TWO_SIDED|95.0|-2.93|0.63|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||0.63|-2.93|0.2048
71090875|NCT02081807|141688009|OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.45|0.94|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.94|0.45|
71152028|NCT02304367|141795830|SUPERIORITY|||||||0.027|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.027
71152029|NCT02304367|141795830|OTHER|||||||0.312|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.312
70968504|NCT00880399|141442995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.16||||0.0312|TWO_SIDED|95.0|-4.12|-0.2|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||-0.20|-4.12|0.0312
70968505|NCT00880399|141442995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.34||||0.0202|TWO_SIDED|95.0|-4.31|-0.37|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.37|-4.31|0.0202
70968506|NCT00880399|141442996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.45||||0.7246|TWO_SIDED|95.0|-20.38|29.28|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, TST at Week 1||29.28|-20.38|0.7246
70968507|NCT00880399|141442996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.36||||0.0332|TWO_SIDED|95.0|2.2|52.52|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, TST at Week 1||52.52|2.20|0.0332
70968508|NCT00880399|141442996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.12||||0.5439|TWO_SIDED|95.0|-18.18|34.41|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, TST at Week 2||34.41|-18.18|0.5439
70968509|NCT00880399|141442996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.52||||0.3127|TWO_SIDED|95.0|-12.8|39.85|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, TST at Week 2||39.85|-12.80|0.3127
70968510|NCT00880399|141442996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.51||||0.2419|TWO_SIDED|95.0|-46.9|11.89|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, TST at Week 4||11.89|-46.90|0.2419
70968511|NCT00880399|141442996|SUPERIORITY_OR_OTHER||Median Difference (Net)|21.11||||0.1606|TWO_SIDED|95.0|-8.43|50.64|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, TST at Week 4||50.64|-8.43|0.1606
70968512|NCT00880399|141442996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.48||||0.7412||95.0|-22.21|31.16|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, TST at Week 6||31.16|-22.21|0.7412
70968513|NCT00880399|141442996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.47||||0.3974|TWO_SIDED|95.0|-15.19|38.14|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, TST at Week 6||38.14|-15.19|0.3974
70968514|NCT00880399|141442996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.52||||0.1397|TWO_SIDED|95.0|-26.83|3.79|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SOL at Week 1||3.79|-26.83|0.1397
70968515|NCT00880399|141442996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.9||||0.0026|TWO_SIDED|95.0|-39.4|-8.41|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SOL at Week 1||-8.41|-39.40|0.0026
71029524|NCT00090857|141567098|SUPERIORITY_OR_OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Sample size for a detectable difference in the within participant change in bone density was calculated using standard deviations of one year change in bone density. Control estimates were 2.8% for spine and 3.85% for femoral neck. With 100 patients and 2:1 randomization (67 letrozole: 33 placebo), using a 1-sided Wilcoxon rank sum test with size 0.05, there is 80% power to detect as significant a true difference in change in the spine of 1.6% and in the femoral neck of 2.27%.||||0.06
71029525|NCT00090857|141567099|SUPERIORITY_OR_OTHER|||||||0.38|||||||Fisher Exact|||||||0.38
71152030|NCT02304367|141795830|OTHER|||||||0.249|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.249
71152031|NCT02304367|141795830|OTHER|||||||0.102|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.102
70968516|NCT00880399|141442996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.67||||0.3206|TWO_SIDED|95.0|-22.85|7.5|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SOL at Week 2||7.50|-22.85|0.3206
70968517|NCT00880399|141442996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.67||||0.0015|TWO_SIDED|95.0|-39.86|-9.49|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SOL at Week 2||-9.49|-39.86|0.0015
70968518|NCT00880399|141442996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.71||||0.2157|TWO_SIDED|95.0|-27.7|6.28|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SOL at Week 4||6.28|-27.70|0.2157
70968519|NCT00880399|141442996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.31||||0.0784|TWO_SIDED|95.0|-32.37|1.75|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SOL at Week 4||1.75|-32.37|0.0784
70968520|NCT00880399|141442996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.84||||0.3345|TWO_SIDED|95.0|-7.09|20.78|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SOL at Week 6||20.78|-7.09|0.3345
70968521|NCT00880399|141442996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.25||||0.6471|TWO_SIDED|95.0|-17.19|10.7|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SOL at Week 6||10.70|-17.19|0.6471
70968522|NCT00880399|141442996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.4||||0.8071|TWO_SIDED|95.0|-16.95|21.75|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, WTSO at Week 1||21.75|-16.95|0.8071
70968523|NCT00880399|141442996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.3||||0.3564|TWO_SIDED|95.0|-29.11|10.52|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, WTSO at Week 1||10.52|-29.11|0.3564
70968524|NCT00880399|141442996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.86||||0.122|TWO_SIDED|95.0|-36.0|4.28|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, WTSO at Week 2||4.28|-36.00|0.1220
70968525|NCT00880399|141442996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.25||||0.0313|TWO_SIDED|95.0|-42.49|-2.01|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, WTSO at Week 2||-2.01|-42.49|0.0313
70968526|NCT00880399|141442996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.15||||0.8861|TWO_SIDED|95.0|-27.45|31.76|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, WTSO at Week 4||31.76|-27.45|0.8861
70968527|NCT00880399|141442996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.67||||0.9132|TWO_SIDED|95.0|-31.87|28.53|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, WTSO at Week 4||28.53|-31.87|0.9132
70968528|NCT00880399|141442996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.09||||0.7844|TWO_SIDED|95.0|-33.55|25.37|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, WTSO at Week 6||25.37|-33.55|0.7844
70968529|NCT00880399|141442996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9||||0.8497|TWO_SIDED|95.0|-27.33|33.14|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, WTSO at Week 6||33.14|-27.33|0.8497
70968530|NCT00880399|141442997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.4814|TWO_SIDED|95.0|-0.83|0.39|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||0.39|-0.83|0.4814
71152032|NCT02304367|141795831|OTHER|||||||0.856|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.856
70968531|NCT00880399|141442997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.6179|TWO_SIDED|95.0|-0.47|0.79|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||0.79|-0.47|0.6179
70968532|NCT00880399|141442997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.5022|TWO_SIDED|95.0|-0.44|0.21|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||0.21|-0.44|0.5022
70968533|NCT00880399|141442997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.1389|TWO_SIDED|95.0|-0.57|0.08|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||0.08|-0.57|0.1389
70968534|NCT00880399|141442997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.9663|TWO_SIDED|95.0|-0.36|0.38|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||0.38|-0.36|0.9663
71029526|NCT00090857|141567100|SUPERIORITY_OR_OTHER|||||||0.02|||||||Fisher Exact|||||||0.02
71152033|NCT02304367|141795831|OTHER|||||||0.898|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.898
70968535|NCT00880399|141442997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29||||0.1311|TWO_SIDED|95.0|-0.67|0.09|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||0.09|-0.67|0.1311
70968536|NCT00880399|141442997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31||||0.1362|TWO_SIDED|95.0|-0.73|0.1|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||0.10|-0.73|0.1362
70968537|NCT00880399|141442997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48||||0.0275|TWO_SIDED|95.0|-0.91|-0.05|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.05|-0.91|0.0275
70968538|NCT00880399|141442998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.52||||0.0606|TWO_SIDED|95.0|-0.02|1.06|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SQ at Week 1||1.06|-0.02|0.0606
70968539|NCT00880399|141442998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.69||||0.0132|TWO_SIDED|95.0|0.15|1.24|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SQ at Week 1||1.24|0.15|0.0132
70968540|NCT00880399|141442998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.94||||0.001|TWO_SIDED|95.0|0.38|1.5|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SQ at Week 2||1.50|0.38|0.0010
70968541|NCT00880399|141442998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.84||||0.0034|TWO_SIDED|95.0|0.28|1.4|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SQ at Week 2||1.40|0.28|0.0034
70968542|NCT00880399|141442998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13||||0.6692|TWO_SIDED|95.0|-0.47|0.72|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SQ at Week 4||0.72|-0.47|0.6692
70968543|NCT00880399|141442998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.82||||0.0078|TWO_SIDED|95.0|0.22|1.42|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SQ at Week 4||1.42|0.22|0.0078
70968544|NCT00880399|141442998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.66||||0.044|TWO_SIDED|95.0|0.02|1.3|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SQ at Week 6||1.30|0.02|0.0440
71029527|NCT00090857|141567101|SUPERIORITY_OR_OTHER|||||||0.2|||||||Fisher Exact|||||||0.20
71029528|NCT00090857|141567102|SUPERIORITY_OR_OTHER|||||||0.88|||||||Fisher Exact|||||||.88
71029529|NCT00090857|141567103|SUPERIORITY_OR_OTHER|||||||0.27|||||||Fisher Exact|||||||0.27
71029530|NCT00090857|141567104|SUPERIORITY_OR_OTHER|||||||0.6|||||||Fisher Exact|||||||.60
71152034|NCT02304367|141795831|OTHER|||||||0.785|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.785
70968545|NCT00880399|141442998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77||||0.0181|TWO_SIDED|95.0|0.13|1.41|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SQ at Week 6||1.41|0.13|0.0181
70968546|NCT00880399|141442998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.1484|TWO_SIDED|95.0|-0.14|0.92|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, RVS at Week 1||0.92|-0.14|0.1484
70968547|NCT00880399|141442998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7||||0.0108|TWO_SIDED|95.0|0.16|1.24|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, RVS at Week 1||1.24|0.16|0.0108
71152035|NCT02304367|141795831|OTHER|||||||0.932|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.932
71152036|NCT02304367|141795831|OTHER|||||||0.545|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.545
71152037|NCT02304367|141795831|OTHER|||||||0.58|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.580
71152038|NCT02304367|141795831|OTHER|||||||0.462|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.462
70968548|NCT00880399|141442998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.0361||95.0|0.04|1.16|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, RVS at Week 2||1.16|0.04|0.0361
70968549|NCT00880399|141442998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58||||0.0418|TWO_SIDED|95.0|0.02|1.15|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, RVS at Week 2||1.15|0.02|0.0418
70968550|NCT00880399|141442998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.9305|TWO_SIDED|95.0|-0.64|0.58|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, RVS at Week 4||0.58|-0.64|0.9305
70968551|NCT00880399|141442998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77||||0.0141|TWO_SIDED|95.0|0.16|1.39|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, RVS at Week 4||1.39|0.16|0.0141
70968552|NCT00880399|141442998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.65||||0.0562|TWO_SIDED|95.0|-0.02|1.31|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, RVS at Week 6||1.31|-0.02|0.0562
70968553|NCT00880399|141442998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74||||0.0296|TWO_SIDED|95.0|0.07|1.4|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, RVS at Week 6||1.40|0.07|0.0296
70968554|NCT00880399|141443002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2||||0.0735|TWO_SIDED|95.0|-0.21|4.61|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||4.61|-0.21|0.0735
70968555|NCT00880399|141443002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.35||||0.2905|TWO_SIDED|95.0|-1.17|3.86|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||3.86|-1.17|0.2905
70968556|NCT00880399|141443002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.05||||0.4327|TWO_SIDED|95.0|-1.6|3.7|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||3.70|-1.60|0.4327
70968557|NCT00880399|141443002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.01||||0.4642|TWO_SIDED|95.0|-1.73|3.75|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||3.75|-1.73|0.4642
71029531|NCT00090857|141567105|SUPERIORITY_OR_OTHER|||||||0.58|||||||Fisher Exact|||||||.58
71152039|NCT02304367|141795831|OTHER|||||||0.26|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.260
71152040|NCT01869764|141795845|OTHER|||||||0.93|||||||ANOVA|||||||0.93
71152041|NCT01869764|141795846|OTHER|||||||0.29|||||||ANOVA|||||||0.29
71152042|NCT01958164|141795872|SUPERIORITY_OR_OTHER||Mean Difference (Net)|73.3|||||TWO_SIDED|95.0|23.3|89.3|||||Difference calculated as actilyse minus saline solution|||89.3|23.3|
71152043|NCT01958164|141795873|SUPERIORITY_OR_OTHER||Mean Difference (Net)|66.7|||||TWO_SIDED|95.0|20.7|90.3|||||Difference calculated as actilyse minus saline solution|||90.3|20.7|
70968558|NCT00880399|141443002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.48||||0.285|TWO_SIDED|95.0|-1.26|4.23|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||4.23|-1.26|0.2850
70968559|NCT00880399|141443002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.75||||0.5984|TWO_SIDED|95.0|-2.08|3.59|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||3.59|-2.08|0.5984
70968560|NCT00880399|141443002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.21||||0.4192|TWO_SIDED|95.0|-1.76|4.19|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||4.19|-1.76|0.4192
70968561|NCT00880399|141443002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.64||||0.6766|TWO_SIDED|95.0|-2.42|3.71|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||3.71|-2.42|0.6766
70968562|NCT00880399|141443003|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.9951|TWO_SIDED|95.0|-1.26|1.25|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||1.25|-1.26|0.9951
70968563|NCT00880399|141443003|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.894|TWO_SIDED|95.0|-1.17|1.34|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||1.34|-1.17|0.8940
70968564|NCT00880399|141443003|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.8195|TWO_SIDED|95.0|-1.61|1.28|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||1.28|-1.61|0.8195
70968565|NCT00880399|141443003|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.4106|TWO_SIDED|95.0|-0.84|2.05|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||2.05|-0.84|0.4106
71152044|NCT01397968|141795877|SUPERIORITY||||||<|0.0001|||||||Wilcoxon rank sum|||||||<0.0001
71152045|NCT01397968|141795878|SUPERIORITY||||||<|0.0001|||||||Regression, Logistic|||||||<0.0001
71152046|NCT02970162|141795888|SUPERIORITY|||||||0.0004||||||LS means|Least square means|Fixed effects treatment and QMG at Baseline. Between-treatment difference in LS means (95% CI) -6.54 (-9.78, -3.29).||||||0.0004
71152047|NCT02970162|141795889|SUPERIORITY||LS means|2.95||||0.0003|TWO_SIDED|95.0|1.53|4.38||CFB for SGI score was modeled as the response, with fixed effects terms for treatment and SGI at Baseline|Fixed effects linear model|This statistical test applies to the change from baseline SGI scores to Day 4 values row.||||4.38|1.53|0.0003
71152048|NCT02970162|141795890|SUPERIORITY|||||||0.002|||||||Wilcoxon Rank Sum Test|||||||0.0020
71152049|NCT02970162|141795891|SUPERIORITY|||||||0.0112|||||||Fisher Exact|||||||0.0112
71152050|NCT00298558|141795907|SUPERIORITY_OR_OTHER||Effect Size|0.06||||0.43|TWO_SIDED|99.0|-0.14|0.27|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.27|-0.14|0.43
71152051|NCT00298558|141795907|SUPERIORITY_OR_OTHER||Effect Size|-0.11||||0.17|TWO_SIDED|99.0|-0.31|0.1|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.10|-0.31|0.17
71152052|NCT00298558|141795907|SUPERIORITY_OR_OTHER||Effect Size|-0.05||||0.52|TWO_SIDED|99.0|-0.25|0.15|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.15|-0.25|0.52
71152053|NCT00298558|141795910|SUPERIORITY_OR_OTHER||Effect Size|-0.02||||0.69|TWO_SIDED|99.0|-0.17|0.12|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.12|-0.17|0.69
71152054|NCT00298558|141795910|SUPERIORITY_OR_OTHER||Effect Size|0.23|||<|0.01|TWO_SIDED|99.0|0.09|0.38|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.38|0.09|<0.01
71152055|NCT00298558|141795910|SUPERIORITY_OR_OTHER||Effect Size|-0.06||||0.27|TWO_SIDED|99.0|-0.2|0.08|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.08|-0.20|0.27
71152056|NCT00298558|141795912|SUPERIORITY_OR_OTHER||Effect Size|-0.07||||0.45|TWO_SIDED|99.0|-0.29|0.16|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.16|-0.29|0.45
70968566|NCT00880399|141443003|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.9403|TWO_SIDED|95.0|-1.71|1.85|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||1.85|-1.71|0.9403
70968567|NCT00880399|141443003|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.58||||0.5206|TWO_SIDED|95.0|-2.36|1.2|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||1.20|-2.36|0.5206
70968568|NCT00880399|141443003|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.714|TWO_SIDED|95.0|-2.3|1.58|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||1.58|-2.30|0.7140
70968569|NCT00880399|141443003|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.26||||0.0234|TWO_SIDED|95.0|-4.22|-0.31|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.31|-4.22|0.0234
70968570|NCT04353284|141443004|SUPERIORITY||Mean Difference (Net)|0.74||||0.06|TWO_SIDED|95.0|-0.03|1.51|||Mixed Models Analysis|||This analysis compares the change from baseline between treatment arms.||1.51|-0.03|0.06
70968571|NCT04353284|141443005|SUPERIORITY||Mean Difference (Net)|0.06||||0.87|TWO_SIDED|95.0|-0.7|0.83|||Mixed Models Analysis|||||0.83|-0.70|0.87
70968572|NCT04353284|141443006|SUPERIORITY||Mean Difference (Net)|0.23||||0.69|TWO_SIDED|95.0|-0.94|1.4|||Mixed Models Analysis|||||1.4|-0.94|0.69
70968573|NCT04353284|141443007|SUPERIORITY||Odds Ratio (OR)|1.3||||0.71|TWO_SIDED|95.0|0.33|5.09|||GEE|||Nasopharyngeal Swab Samples analyzed.||5.09|0.33|0.71
71029532|NCT00090857|141567106|SUPERIORITY_OR_OTHER|||||||0.49|||||||Fisher Exact|||||||.49
71152057|NCT00298558|141795912|SUPERIORITY_OR_OTHER||Effect Size|0.005||||0.95|TWO_SIDED|99.0|-0.22|0.23|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.23|-0.22|0.95
71152058|NCT00298558|141795912|SUPERIORITY_OR_OTHER||Effect Size|0.66|||<|0.01|TWO_SIDED|99.0|0.43|0.88|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.88|0.43|<0.01
71152059|NCT00298558|141795913|SUPERIORITY_OR_OTHER||Effect Size|0.48|||<|0.01|TWO_SIDED|99.0|0.12|0.84|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.84|0.12|<0.01
70968574|NCT04353284|141443007|SUPERIORITY||Odds Ratio (OR)|0.4||||0.17|TWO_SIDED|95.0|0.11|1.47|||GEE|Within subject correlation is controlled by specifying a compound symmetry R-side structure in the model.||Saliva RT-PCR samples analyzed.||1.47|0.11|0.17
70968575|NCT04353284|141443008|SUPERIORITY||Odds Ratio (OR)|3.05||||0.03|TWO_SIDED|95.0|1.12|8.26|||GEE|Within subject correlation is controlled by specifying a compound symmetry R-side structure in the model.||||8.26|1.12|0.03
70968576|NCT04353284|141443008|SUPERIORITY||Odds Ratio (OR)|1.23||||0.68|TWO_SIDED|95.0|0.47|3.23|||GEE|Within subject correlation is controlled by specifying a compound symmetry R-side structure in the model.||Saliva RT-PCR samples analyzed.||3.23|0.47|0.68
70968577|NCT04353284|141443009|SUPERIORITY||Odds Ratio (OR)|6.28||||0.1|TWO_SIDED|95.0|0.7|56.6|||GEE|Within subject correlation is controlled by specifying a compound symmetry R-side structure in the model.||||56.60|0.70|0.10
70968578|NCT04353284|141443009|SUPERIORITY||Odds Ratio (OR)|0.9||||0.87|TWO_SIDED|95.0|0.25|3.23|||GEE|Within subject correlation is controlled by specifying a compound symmetry R-side structure in the model.||Saliva RT-PCR samples analyzed.||3.23|0.25|0.87
70968579|NCT04353284|141443010|SUPERIORITY||Mean Difference (Net)|-6.6||||0.02|TWO_SIDED|95.0|-12.1|-1.2|||Mixed Models Analysis|||||-1.2|-12.1|0.02
70968580|NCT04353284|141443011|SUPERIORITY||Mean Difference (Net)|-2.1||||0.48|TWO_SIDED|95.0|-7.9|3.7|||Mixed Models Analysis|||||3.7|-7.9|0.48
70968581|NCT04353284|141443012|SUPERIORITY||Mean Difference (Net)|1.0||||0.16|TWO_SIDED|95.0|-0.4|2.3|||Mixed Models Analysis|||||2.3|-0.4|0.16
70968582|NCT04353284|141443013|SUPERIORITY||Mean Difference (Net)|0.7||||0.34|TWO_SIDED|95.0|-0.7|2.1|||Mixed Models Analysis|||||2.1|-0.7|0.34
70968583|NCT01911442|141443016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|2.15||0.5463|TWO_SIDED|95.0|-5.6|3.0|||Mixed Models Analysis|||LS Mean, LS mean difference and the associated 95% Cl and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||3.0|-5.6|0.5463
70968584|NCT01911442|141443016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|2.09||0.3592|TWO_SIDED|95.0|-6.1|2.2|||Mixed Models Analysis|||LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures.||2.2|-6.1|0.3592
70968585|NCT01911442|141443017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.25||0.1755|TWO_SIDED||||||Mixed Models Analysis||This is due to rounding. the LSM for Lurasidone 20 mg/d at week 6 was -1.069 vs -0.734 for placebo group. So the LSM of the treatment difference between Lurasidone 20 mg/d and placebo was 0.335 if 3 decimals are reported.|||||0.1755
70968586|NCT01911442|141443017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.24||0.2402|TWO_SIDED||||||Mixed Models Analysis|||||||0.2402
70968587|NCT00122681|141443028|SUPERIORITY_OR_OTHER||1-Rate Ratio|92.9|||||TWO_SIDED|95.0|79.9|98.3||||||Vaccine efficacy against CIN2+ associated with HPV-16 or HPV-18 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed.||98.3|79.9|
70968588|NCT00122681|141443028|SUPERIORITY_OR_OTHER||1-Rate Ratio|95.7|||||TWO_SIDED|95.0|82.9|99.6||||||Vaccine efficacy against CIN2+ associated with HPV-16 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed.||99.6|82.9|
70968589|NCT00122681|141443028|SUPERIORITY_OR_OTHER||1-Rate Ratio|86.7|||||TWO_SIDED|95.0|39.7|98.7||||||Vaccine efficacy against CIN2+ associated with HPV-18 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed.||98.7|39.7|
71008426|NCT03018028|141524710|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.23||||0.0098|TWO_SIDED|95.0|0.07|0.7||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.70|0.07|0.0098
71152060|NCT00298558|141795913|SUPERIORITY_OR_OTHER||Effect Size|0.38|||<|0.01|TWO_SIDED|99.0|0.02|0.74|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.74|0.02|<0.01
71152061|NCT00298558|141795913|SUPERIORITY_OR_OTHER||Effect Size|0.36|||<|0.01|TWO_SIDED|99.0|0.01|0.72|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.72|0.01|<0.01
71152062|NCT00298558|141795914|SUPERIORITY_OR_OTHER||Effect Size|0.004||||0.97|TWO_SIDED|99.0|-0.23|0.24|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.24|-0.23|0.97
71152063|NCT00298558|141795914|SUPERIORITY_OR_OTHER||Effect Size|-0.02||||0.86|TWO_SIDED|99.0|-0.25|0.22|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.22|-0.25|0.86
71152064|NCT00298558|141795914|SUPERIORITY_OR_OTHER||Effect Size|0.008||||0.93|TWO_SIDED|99.0|-0.23|0.24|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.24|-0.23|0.93
71152065|NCT00298558|141795915|SUPERIORITY_OR_OTHER||Effect Size|0.02||||0.78|TWO_SIDED|99.0|-0.19|0.23|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.23|-0.19|0.78
71152066|NCT00298558|141795915|SUPERIORITY_OR_OTHER||Effect Size|-0.004||||0.96|TWO_SIDED|99.0|-0.21|0.21|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.21|-0.21|0.96
71152067|NCT00298558|141795915|SUPERIORITY_OR_OTHER||Effect Size|-0.05||||0.56|TWO_SIDED|99.0|-0.26|0.16|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.16|-0.26|0.56
71152068|NCT01322945|141795948|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||||||0.001
71152069|NCT01255436|141795967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2||||0.06|TWO_SIDED|95.0|-9.4|1.0||p-value\<0.05 is considered significant|t-test, 1 sided|||||1.0|-9.4|0.06
70925894|NCT05794243|141345583|OTHER||Ratio of Geometric Least Squares Means|0.399|||||TWO_SIDED|90.0|0.237|0.669|||Mixed Models Analysis|||AUC (0-∞) was log-transformed and analyzed via mixed model for repeated measures with fixed effects for treatment, profile day and the treatment-by-day interaction, and a random effect for participant. The LSMs and differences in LSMs were back transformed to produce the ratio between GLSMs.||0.669|0.237|
71152070|NCT01255436|141795968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.14|TWO_SIDED|95.0|-4.1|1.3||p-value \< 0.05 considered significant|t-test, 1 sided|||||1.3|-4.1|0.14
71152071|NCT01255436|141795969|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.045|TWO_SIDED|95.0|1.0|1.6|||Fisher Exact||Numerator is Treatment Group (SMS reminders) and Denominator is Control Group (No SMS reminders)|||1.6|1.0|0.045
70968590|NCT00122681|141443028|SUPERIORITY_OR_OTHER||1-Rate Ratio|90.8|||||TWO_SIDED|95.0|78.1|96.9||||||Vaccine efficacy against CIN2+ for HPV-16 or HPV-18 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).||96.9|78.1|
70968591|NCT00122681|141443028|SUPERIORITY_OR_OTHER||1-Rate Ratio|92.7|||||TWO_SIDED|95.0|79.3|98.2||||||Vaccine efficacy against CIN2+ for HPV-16 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).||98.2|79.3|
70968592|NCT00122681|141443028|SUPERIORITY_OR_OTHER||1-Rate Ratio|87.6|||||TWO_SIDED|95.0|44.1|98.8||||||Vaccine efficacy against CIN2+ for HPV-18 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).||98.8|44.1|
70968593|NCT00122681|141443029|SUPERIORITY_OR_OTHER||1-Rate Ratio|94.9|||||TWO_SIDED|95.0|87.7|98.4||||||Vaccine efficacy against CIN2+ associated with HPV-16 or HPV-18 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed||98.4|87.7|
70968594|NCT00122681|141443029|SUPERIORITY_OR_OTHER||1-Rate Ratio|97.6|||||TWO_SIDED|95.0|91.0|99.7||||||Vaccine efficacy against CIN2+ associated with HPV-16 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed||99.7|91.0|
70968595|NCT00122681|141443029|SUPERIORITY_OR_OTHER||1-Rate Ratio|87.1|||||TWO_SIDED|95.0|57.2|97.5||||||Vaccine efficacy against CIN2+ associated with HPV-18 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed.||97.5|57.2|
70968596|NCT00122681|141443029|SUPERIORITY_OR_OTHER||1-Rate Ratio|93.6|||||TWO_SIDED|95.0|86.3|97.5||||||Vaccine efficacy against CIN2+ for HPV-16 or HPV-18 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).||97.5|86.3|
70925895|NCT05794243|141345585|OTHER||Ratio of Geometric Least Squares Means|0.106|||||TWO_SIDED|90.0|0.062|0.182|||Mixed Models Analysis|||Cmax was log-transformed and analyzed via mixed model for repeated measures with fixed effects for treatment, profile day and the treatment-by-day interaction, and a random effect for participant. The LSMs and differences in LSMs were back transformed to produce the ratio between GLSMs.||0.182|0.0620|
70968597|NCT00122681|141443029|SUPERIORITY_OR_OTHER||1-Rate Ratio|95.7|||||TWO_SIDED|95.0|88.5|98.9||||||Vaccine efficacy against CIN2+ for HPV-16 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).||98.9|88.5|
71029533|NCT05097326|141567107|OTHER|||||||0.44||||||a p-value \<0.05 would be considered statistically significant|Fisher Exact|||Analysis of total contractions||||0.44
71029534|NCT05097326|141567107|OTHER|||||||0.02||||||a p-value of \<0.05 would be considered statistically significant|Fisher Exact|||Analysis of contractions per hour||||0.02
71090876|NCT02081807|141688010|OTHER||Hazard Ratio (HR)|0.37|||||TWO_SIDED|95.0|0.18|0.78|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.78|0.18|
71152072|NCT01255436|141795970|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.014|TWO_SIDED|95.0|1.04|1.53|||Fisher Exact|||||1.53|1.04|0.014
71152073|NCT02223858|141795983|SUPERIORITY|A sample size of 360 patients (180 non-Hispanic white and 180 non-Hispanic African American) was chosen based on a priori power calculations to detect a 3-way interaction between treatment group, race, and time, assuming a 20% change in baseline, the WOMAC pain subscales, and a 80% power.||||||0.791|||||||Mixed Models Analysis|All models adjusted for site.||||||0.791
71152074|NCT02223858|141795984|SUPERIORITY|A sample size of 360 (180 non-Hispanic white and 180 non-Hispanic African American) was chosen based on a priori power calculations to detect a 3-way interaction between treatment group, race, and time, assuming a 20% change in baseline, the WOMAC pain subscales, and a 80% power.||||||0.88|||||||Mixed Models Analysis|All models adjusted for site.||||||0.880
70968598|NCT00122681|141443029|SUPERIORITY_OR_OTHER||1-Rate Ratio|87.6|||||TWO_SIDED|95.0|59.2|97.6||||||Vaccine efficacy against CIN2+ for HPV-18 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).||97.6|59.2|
70968599|NCT00122681|141443054|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.798||||0.391|TWO_SIDED|95.0|0.476|1.337|||Chi-squared|||Hazard ratio of anti-HPV-16 GMTs at Month 7 (by ELISA) in subjects without 6-month persistent infection compared to subjects with 6-month persistent infection||1.337|0.476|0.3910
70968600|NCT00122681|141443056|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.778||||0.3796|TWO_SIDED|95.0|0.444|1.362|||Chi-squared|||Hazard ratio of anti-HPV-16 GMTs at Month 7 (by ELISA) in subjects without 12-month persistent infection compared to subjects with 12-month persistent infection.||1.362|0.444|0.3796
71152075|NCT02223858|141795985|SUPERIORITY|A sample size of 360 (180 non-Hispanic white and 180 non-Hispanic African American) was chosen based on a priori power calculations to detect a 3-way interaction between treatment group, race, and time, assuming a 20% change in baseline, the WOMAC pain subscale, and a 80% power.||||||0.901|||||||Mixed Models Analysis|All models adjusted for site.||||||0.901
71152076|NCT03682770|141795995|SUPERIORITY||Difference in percentage|20.23||||0.042|TWO_SIDED|95.0|1.266|39.189||The p-value was derived by Cochran-Mantel-Haenszel (CMH) test stratified by screening peanut-specific IgE level and baseline body weight.|Cochran-Mantel-Haenszel||Difference in percentage derived by Mantel-Haenszel (MH) method|||39.189|1.266|0.0420
71152077|NCT03682770|141795996|SUPERIORITY||Least Square Mean Difference|0.67||||0.04|TWO_SIDED|95.0|0.031|1.305||P-value is based on treatment difference (dupilumab + AR101 vs placebo + AR101) of the LS mean change using analysis of covariance (ANCOVA) model.|ANCOVA|||||1.305|0.031|0.0400
70968601|NCT00122681|141443058|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.1035||95.0|0.337|1.106|||Chi-squared|||Hazard ratio of anti-HPV-18 GMTs at Month 7 (by ELISA) in subjects without 6-month persistent infection compared to subjects with 6-month persistent infection.||1.106|0.337|0.1035
71152078|NCT03682770|141795997|SUPERIORITY||Difference in percentage|11.91||||0.0806|TWO_SIDED|95.0|-3.612|27.44||P-values were derived by CMH test stratified by screening peanut-specific IgE level (\<=100 kilo allergy unit per liter \[kUA/L\] vs \>100 kUA/L) and body weight (\<30 kg, \>=30 and \<60 kg, or \>=60 kg).|Cochran-Mantel-Haenszel||Difference in percentage derived by MH method|||27.440|-3.612|0.0806
71029535|NCT05097326|141567108|OTHER|||||||0.04||||||a p-value of \<0.05 would be considered statistically significant|Fisher Exact|||Comparison at 12 hours after labor induction||||0.04
71152079|NCT03682770|141795999|SUPERIORITY||Difference in percentage|10.4||||0.353|TWO_SIDED|95.0|-11.668|32.474||P-values were derived by CMH test stratified by screening peanut-specific IgE level (\<=100 kUA/L vs \>100 kUA/L) and baseline body weight (\<30 kg, \>=30 kg and \<60 kg, or \>=60 kg).|Cochran-Mantel-Haenszel||Difference in percentage derived by MH method|||32.474|-11.668|0.3530
71152080|NCT03682770|141796000|SUPERIORITY||Least Square Mean Difference|0.37||||0.2628|TWO_SIDED|95.0|-0.281|1.029||P-value is based on treatment difference of the LS mean change using ANCOVA model with baseline tolerated cumulative amount of peanut protein DBPCFC (log transformed) as covariate and the treatment screening peanut-specific IgE level and baseline.|ANCOVA|||||1.029|-0.281|0.2628
71152081|NCT03682770|141796001|SUPERIORITY||Difference in percentage|-2.36||||0.814|TWO_SIDED|95.0|-25.004|20.282||P-values were derived by CMH test stratified by screening peanut-specific IgE level (\<=100 kUA/L vs \>100 kUA/L) and baseline body weight (\<30 kg, \>=30 kg and \<60 kg, or \>=60 kg).|Cochran-Mantel-Haenszel||Difference in percentage derived by MH method|||20.282|-25.004|0.8140
71152082|NCT03682770|141796002|SUPERIORITY||Least Square Mean Difference|-0.05||||0.8805|TWO_SIDED|95.0|-0.699|0.599||P-value is based on treatment difference of the LS mean change using ANCOVA model with baseline tolerated cumulative amount of peanut protein DBPCFC (log transformed) as covariate and the treatment screening peanut-specific IgE level and baseline.|ANCOVA|||||0.599|-0.699|0.8805
70968602|NCT00122681|141443060|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.635||||0.2111|TWO_SIDED|95.0|0.312|1.293|||Chi-squared|||Hazard ratio of anti-HPV-18 GMTs at Month 7 (by ELISA) in subjects without 12-month persistent infection compared to subjects with 12-month persistent infection.||1.293|0.312|0.2111
70968603|NCT02819635|141443063|SUPERIORITY||Adjusted risk difference (%)|8.4||||0.049|TWO_SIDED|95.0|0.0|16.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||16.8|0.0|0.049
71029536|NCT05097326|141567108|OTHER|||||||0.17||||||a p-value of \<0.05 would be considered statistically significant|Fisher Exact|||Comparison of uterine tachysystole of total labor duration||||0.17
71152083|NCT03682770|141796004|SUPERIORITY||Difference percentage|-85.55|||<|0.0001|TWO_SIDED|95.0|-99.47|-73.91||P-value was based on treatment difference (vs. Continuously on Placebo + AR101) in percent change from baseline using rank-based ANCOVA model with baseline measurement as covariate,- and stratification factors and the treatment as fixed factors.|ANCOVA||Median difference and its 95% CIs were estimated with the Hodges-Lehmann method.|||-73.91|-99.47|<0.0001
71152084|NCT03682770|141796005|SUPERIORITY||Difference in percentage|-68.78|||<|0.0001|TWO_SIDED|95.0|-86.71|-56.4||P-value was based on treatment difference (vs. Continuously on Placebo + AR101) in percent change from baseline using rank-based ANCOVA model with baseline measurement as covariate, and stratification factors and the treatment as fixed factors.|ANCOVA||Median difference and its 95% CIs were estimated with the Hodges-Lehmann method.|||-56.40|-86.71|<0.0001
71152085|NCT02362282|141796006|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||||||0.54
71029537|NCT05097326|141567109|OTHER|||||||0.63||||||a p-value \<0.05 would be considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.63
71029538|NCT05097326|141567110|OTHER|||||||0.01||||||a p-value of \<0.05 would be considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.01
71029539|NCT05097326|141567111|OTHER|||||||0.04||||||a p-value of \<0.05 would be considered statistically significant|Wilcoxon (Mann-Whitney)|||Comparison at complete cervical dilation||||0.04
71152086|NCT03599089|141796009|SUPERIORITY|||||||0.005|||||||ANOVA|||||||0.005
71152087|NCT03599089|141796010|SUPERIORITY|||||||0.0245|||||||Regression, Logistic|||||||0.0245
71152088|NCT03599089|141796011|SUPERIORITY|||||||0.0019|||||||ANOVA|||||||0.0019
71152089|NCT02289157|141796057|OTHER||Risk Ratio (RR)|0.9||||0.54|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|Ho: There is no difference between number of patients with wound complications between the study (icNPT) and comparison groups.||||1.4|0.5|0.54
70906988|NCT02942004|141303700|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0493|TWO_SIDED|95.0|1.0|6.9|||GEE method|||Hour 60: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||6.9|1.0|0.0493
70968604|NCT02819635|141443063|SUPERIORITY||Adjusted risk difference (%)|13.5||||0.01|TWO_SIDED|95.0|3.3|23.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||23.8|3.3|0.010
70968605|NCT02819635|141443063|SUPERIORITY||Adjusted risk difference (%)|13.8||||0.007|TWO_SIDED|95.0|3.8|23.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||23.9|3.8|0.007
70968606|NCT02819635|141443063|SUPERIORITY||Adjusted risk difference (%)|21.1|||<|0.001|TWO_SIDED|95.0|8.6|33.6||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||33.6|8.6|<0.001
70968607|NCT02819635|141443064|SUPERIORITY||Adjusted risk difference (%)|21.6|||<|0.001|TWO_SIDED|95.0|15.8|27.4||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes vs. no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||27.4|15.8|<0.001
70968608|NCT02819635|141443065|SUPERIORITY||Adjusted risk difference (%)|30.7|||<|0.001|TWO_SIDED|95.0|21.7|39.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Baseline of Induction Study; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||39.8|21.7|<0.001
70968609|NCT02819635|141443065|SUPERIORITY||Adjusted risk difference (%)|39.0|||<|0.001|TWO_SIDED|95.0|29.7|48.2||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Baseline of Induction Study; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||48.2|29.7|<0.001
71029540|NCT05097326|141567112|OTHER|||||||0.04||||||a p-value of \<0.05 would be considered statistically significant|Wilcoxon (Mann-Whitney)|||Comparison at postpartum transfer||||0.04
71029541|NCT05097326|141567113|OTHER|||||||0.68||||||a p-value of \<0.05 would be considered statistically significant|Fisher Exact|||||||0.68
71152090|NCT02289157|141796058|OTHER|||||||0.31|||||||Chi-squared|Pearson Chi-squared, df (3)||Ho: There is no difference between the types wound morbidity in the study (icNPT) and comparison groups.||||0.31
71152091|NCT02289157|141796059|OTHER|||||||0.54||||||Ho: There is no difference between initial length of stay between the study (icNPT) and comparison groups.|Wilcoxon (Mann-Whitney)|||||||0.54
71152092|NCT02289157|141796060|OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Ho: There is no difference in length of stay after readmission for wound morbidity between the study (icNPT) and comparison groups.||||0.41
71152093|NCT02289157|141796061|OTHER|||||||0.38|||||||Chi-squared|||Ho: There is no difference between the number of ER visits made per person between the study (icNPT) and comparison groups.||||0.38
71152094|NCT02289157|141796062|OTHER|||||||0.48||||||Ho: There is no difference between the number of visits made to the clinic for wound morbidity per patient between the study (icNPT) and comparison groups.|Chi-squared|||||||0.48
71152095|NCT02289157|141796063|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Ho: There is no difference between number of readmissions between the study (icNPT) and comparison groups.||||0.52
71152096|NCT02289157|141796063|OTHER|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Ho: There is no difference in the use of post operative antimicrobials between the the study (icNPT) and comparison groups.||||0.45
71152097|NCT02289157|141796063|OTHER|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Ho: There is no difference in the number of patients with Incision and Drainage and/or Extirpation between the study (icNPT) and comparison groups.||||0.44
71152098|NCT02289157|141796064|OTHER|Cochran-Mantel-Haenzel test for interactions between different risk factors: scheduled vs unscheduled cesarean section and icNPT vs Standard dressing||||||0.68||||||Ho: There is no difference between patients with wound morbidity that is significantly affected by the use of icNPT and whether or not the cesarean is scheduled or unscheduled.|Cochran-Mantel-Haenszel|||||||0.68
71152099|NCT02289157|141796065|OTHER|Cochran-Mantel-Haenzel test for interactions between different risk factors: pfannenstiel vs midline abdominal incision and icNPT vs Standard dressing||||||0.27|||||||Cochran-Mantel-Haenszel|||||||0.27
71152100|NCT02289157|141796066|OTHER|Cochran-Mantel-Haenzel test for interactions between different risk factors: ruptured vs unruptured membranes and icNPT vs Standard dressing||||||0.55|||||||Cochran-Mantel-Haenszel|||||||0.55
71152101|NCT02289157|141796067|OTHER|Cochran-Mantel-Haenzel test for interactions between labor vs no labor stratified by icNPT vs Standard dressing||||||0.49|||||||Cochran-Mantel-Haenszel|||||||0.49
71152102|NCT02289157|141796068|OTHER|Cochran-Mantel-Haenzel measure used to estimate interaction between patients with hypertension versus no hypertension stratified by icNPT versus standard dressing in wound morbidity||||||0.92|||||||Cochran-Mantel-Haenszel|||||||0.92
71152103|NCT02289157|141796069|OTHER|Cochran-Mantel-Haenzel measure used to estimate interaction in icNPT and Standard wound dressings stratified by women with insulin requiring diabetes and no insulin requiring Diabetes.||||||0.22|||||||Cochran-Mantel-Haenszel|||||||0.22
70968610|NCT02819635|141443066|SUPERIORITY||Adjusted risk difference (%)|13.1||||0.03|TWO_SIDED|95.0|1.2|25.0||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||25.0|1.2|0.030
70968611|NCT02819635|141443066|SUPERIORITY||Adjusted risk difference (%)|27.6|||<|0.001|TWO_SIDED|95.0|13.1|42.1||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||42.1|13.1|<0.001
70968612|NCT02819635|141443066|SUPERIORITY||Adjusted risk difference (%)|26.6|||<|0.001|TWO_SIDED|95.0|12.3|40.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||40.8|12.3|<0.001
70968613|NCT02819635|141443066|SUPERIORITY||Adjusted risk difference (%)|35.4|||<|0.001|TWO_SIDED|95.0|19.2|51.7||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||51.7|19.2|<0.001
70968614|NCT02819635|141443067|SUPERIORITY||Adjusted risk difference (%)|11.0||||0.021|TWO_SIDED|95.0|1.7|20.4||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||20.4|1.7|0.021
71029542|NCT05097326|141567114|OTHER|||||||1||||||A p-value of \<0.05 would be considered significant.|Fisher Exact|||||||1
71152104|NCT02289157|141796070|OTHER|Cochran-Mantel-Haenzel measure used to estimate interaction between chorioamnionitis and no chorioamnionitis stratified by icNPT and standard dressing, for wound morbidity||||||0.74|||||||Cochran-Mantel-Haenszel|||||||0.74
71029543|NCT05097326|141567115|OTHER|||||||1||||||a p-value of \<0.05 would be considered statistically significant|Fisher Exact|||||||1
71152105|NCT02983552|141796076|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.71|TWO_SIDED|95.0|-2.2|1.7||a priori threshold for statistical significance: 2-sided type I error rate of 5%|ANOVA|Adjusted for baseline amblyopic-eye visual acuity.|A 2-sided 95% confidence interval was computed on the adjusted treatment group difference evaluating change in amblyopic-eye visual acuity from baseline to the 4 week visit.|A modified intent-to-treat analysis was performed using an ANCOVA model to compare the effectiveness of two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. The primary outcome measure was change in amblyopic-eye VA from baseline to 4 weeks. A 2-sided 95% confidence interval (CI) was computed on the adjusted treatment group difference at 4 weeks. There was no imputation for missing data.||1.7|-2.2|0.71
71152106|NCT02983552|141796078|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|98.3|-2.4|2.1|||||A 2-sided 98.3% confidence interval was computed on the adjusted treatment group difference evaluating change in amblyopic-eye visual acuity from baseline to the 8-week visit.|||2.1|-2.4|
71152107|NCT02983552|141796084|SUPERIORITY||Mean Difference (Final Values)|-2.0|||||TWO_SIDED|98.3|-13.0|9.0||||||Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 4-week visit, adjusted for visual acuity at randomization.||9|-13|
71152108|NCT02983552|141796085|SUPERIORITY||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|98.3|-15.0|12.0||||||Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 8-week visit, adjusted for visual acuity at randomization.|For secondary visual acuity outcomes, which included the 8-week treatment group comparison, a Bonferroni adjustment was used to control for multiple testing (3 outcomes tested) to preserve the overall type I error rate at 5% (2-sided alpha=0.017 per test).|12|-15|
71029544|NCT05097326|141567116|OTHER|||||||0.9||||||A p-value \<0.05 would be considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.90
71029545|NCT05097326|141567117|OTHER|||||||0.17||||||a p-value \<0.05 would be considered statistically significant|Fisher Exact|||1 minute APGAR score||||0.17
71029546|NCT05097326|141567117|OTHER|||||||1||||||A p-value of \<0.05 would be statistically significant.|Fisher Exact|||APGAR score at 5 minutes||||1
71029547|NCT05097326|141567118|OTHER|||||||0.22||||||A p-value of \<0.05 would be considered statistically significant|Fisher Exact|||||||0.22
70968615|NCT02819635|141443067|SUPERIORITY||Adjusted risk difference (%)|9.6||||0.024|TWO_SIDED|95.0|1.3|18.0||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||18.0|1.3|0.024
70968616|NCT02819635|141443067|SUPERIORITY||Adjusted risk difference (%)|12.2||||0.015|TWO_SIDED|95.0|2.3|22.0||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||22.0|2.3|0.015
70968617|NCT02819635|141443067|SUPERIORITY||Adjusted risk difference (%)|20.1||||0.001|TWO_SIDED|95.0|8.0|32.1||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||32.1|8.0|0.001
70968618|NCT02819635|141443068|SUPERIORITY||Adjusted risk difference (%)|16.7||||0.038|TWO_SIDED|95.0|0.9|32.5||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||32.5|0.9|0.038
70968619|NCT02819635|141443068|SUPERIORITY||Adjusted risk difference (%)|35.2|||<|0.001|TWO_SIDED|95.0|17.5|52.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||52.8|17.5|<0.001
71152109|NCT02983552|141796087|SUPERIORITY|||||||0.38||||||The exact Wilcoxon rank-sum test was used to compare the change in stereoacuity levels from baseline to the 4-week visit by treatment group.|Wilcoxon (Mann-Whitney)|||||||0.38
70968620|NCT02819635|141443068|SUPERIORITY||Adjusted risk difference (%)|33.6|||<|0.001|TWO_SIDED|95.0|16.3|50.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||50.8|16.3|<0.001
70968621|NCT02819635|141443068|SUPERIORITY||Adjusted risk difference (%)|45.1|||<|0.001|TWO_SIDED|95.0|26.2|63.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||63.9|26.2|<0.001
70968622|NCT02819635|141443069|SUPERIORITY||Adjusted risk difference (%)|5.9||||0.495|TWO_SIDED|95.0|-11.1|22.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||22.9|-11.1|0.495
71029548|NCT03480425|141567120|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_DEVIATION|4.4|<|0.05|TWO_SIDED|95.0|-2.4|2.6|||t-test, 2 sided|||||2.6|-2.4|<0.05
71029549|NCT02424188|141567121|SUPERIORITY||Odds Ratio (OR)|5.9|||||TWO_SIDED|95.0|2.3|15.4||||||||15.4|2.3|
71029550|NCT02424188|141567122|SUPERIORITY||Odds Ratio (OR)|3.9|||||TWO_SIDED|95.0|1.2|12.3||||||||12.3|1.2|
71152110|NCT02983552|141796089|SUPERIORITY|||||||0.53||||||The exact Wilcoxon rank-sum test was used to compare the change in stereoacuity levels from baseline to the 8-week visit by treatment group.|Wilcoxon (Mann-Whitney)|||||||0.53
71029551|NCT02424188|141567123|SUPERIORITY||Odds Ratio (OR)|4.8|||||TWO_SIDED|95.0|1.3|17.5||||||6 month comparison||17.5|1.3|
71029552|NCT02424188|141567123|SUPERIORITY||Odds Ratio (OR)|10.8|||||TWO_SIDED|95.0|2.4|48.6||||||12 month||48.6|2.4|
71152111|NCT02983552|141796091|SUPERIORITY|||||||0.19||||||The exact Wilcoxon rank-sum test was used to compare the change in stereoacuity levels from baseline to the 4-week visit by treatment group for participants without strabismus.|Wilcoxon (Mann-Whitney)|||||||0.19
71152112|NCT02983552|141796093|SUPERIORITY|||||||0.74||||||The exact Wilcoxon rank-sum test was used to compare the change in stereoacuity levels from baseline to the 8-week visit by treatment group for participants without strabismus.|Wilcoxon (Mann-Whitney)|||||||0.74
71152113|NCT02983552|141796098|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|99.0|-2.5|0.4|||||Statistical significance of the treatment group comparison was based on a 2-sided alpha=0.01.|An analysis of covariance (ANCOVA) model was used to compute the treatment group difference in the mean change in fellow-eye visual acuity (letters) from baseline to 4 weeks, adjusting for fellow-eye visual acuity at randomization. A 2-sided 99% confidence interval was computed on the adjusted treatment group difference.||0.4|-2.5|
71029553|NCT02424188|141567125|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-1.7|2.3||||||6 months||2.3|-1.7|
71029554|NCT02424188|141567125|SUPERIORITY||Mean Difference (Net)|1.6|||||TWO_SIDED|95.0|-1.5|4.7||||||18 months||4.7|-1.5|
71029555|NCT02424188|141567126|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-0.6|1.5||||||||1.5|-0.6|
71029556|NCT02424188|141567128|SUPERIORITY||Mean Difference (Net)|-16.2|||||TWO_SIDED|95.0|-30.2|-2.3||||||||-2.3|-30.2|
71029557|NCT01494506|141567135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.9416|TWO_SIDED|95.0|0.77|1.28|||Log Rank|Unstratified logrank test.||||1.28|0.77|0.9416
71029558|NCT01494506|141567135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.012|TWO_SIDED|95.0|0.49|0.92|||Log Rank|Unstratified logrank test.||||0.92|0.49|0.012
71029559|NCT01494506|141567136|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.1|TWO_SIDED|95.0|0.63|1.04|||Log Rank|||||1.04|0.63|0.100
71029560|NCT01494506|141567136|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.56|||<|0.001|TWO_SIDED|95.0|0.41|0.75|||Log Rank|||||0.75|0.41|<0.001
71029561|NCT01494506|141567137|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0264||||0.214|TWO_SIDED|95.0|-0.005|0.058|||Fisher Exact|||||0.058|-0.005|0.214
71029562|NCT01494506|141567137|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.069||||0.01|TWO_SIDED|95.0|0.018|0.12|||Fisher Exact|||||0.120|0.018|0.010
71029563|NCT01494506|141567138|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.1008|TWO_SIDED|95.0|0.65|1.03|||Log Rank|Unstratified log rank test.||||1.03|0.65|0.1008
71029564|NCT01494506|141567138|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.0002|TWO_SIDED|95.0|0.45|0.78|||Log Rank|Unstratified log rank test||||0.78|0.45|0.0002
71029565|NCT01494506|141567139|SUPERIORITY_OR_OTHER|||||||0.82|||||||Fisher Exact|||||||0.82
71029566|NCT01494506|141567139|SUPERIORITY_OR_OTHER|||||||0.8|||||||Fisher Exact|||||||0.80
71029567|NCT01494506|141567140|SUPERIORITY_OR_OTHER|||||||0.024|||||||Fisher Exact|||||||0.024
71029568|NCT01494506|141567140|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
71029569|NCT01494506|141567141|SUPERIORITY_OR_OTHER|||||||0.6388||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Global Health Status||||0.6388
71029570|NCT01494506|141567141|SUPERIORITY_OR_OTHER|||||||0.8445||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Global Health Status||||0.8445
70925896|NCT05794243|141345585|OTHER||Ratio of Geometric Least Squares Means|0.343|||||TWO_SIDED|90.0|0.206|0.569|||Mixed Models Analysis|||Cmax was log-transformed and analyzed via mixed model for repeated measures with fixed effects for treatment, profile day and the treatment-by-day interaction, and a random effect for participant. The LSMs and differences in LSMs were back transformed to produce the ratio between GLSMs.||0.569|0.206|
71029571|NCT01494506|141567141|SUPERIORITY_OR_OTHER|||||||0.6388||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Physical Functioning||||0.6388
71029572|NCT01494506|141567141|SUPERIORITY_OR_OTHER|||||||0.9435||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Physical Functioning||||0.9435
71029573|NCT01494506|141567141|SUPERIORITY_OR_OTHER|||||||0.2654||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Role functioning||||0.2654
71029574|NCT01494506|141567141|SUPERIORITY_OR_OTHER|||||||0.7674||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Role functioning||||0.7674
71029575|NCT01494506|141567141|SUPERIORITY_OR_OTHER|||||||0.1628||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Emotional Functioning||||0.1628
71029576|NCT01494506|141567141|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Emotional Functioning||||0.6712
71029577|NCT01494506|141567141|SUPERIORITY_OR_OTHER|||||||0.7738||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Cognitive Functioning||||0.7738
71029578|NCT01494506|141567141|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Cognitive Functioning||||0.6712
71029579|NCT01494506|141567141|SUPERIORITY_OR_OTHER|||||||0.3408||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Social Functioning||||0.3408
71152114|NCT02983552|141796099|SUPERIORITY||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|99.0|-2.3|0.3|||||Statistical significance of the treatment group comparison was based on a 2-sided alpha=0.01.|An analysis of covariance (ANCOVA) model was used to compute the treatment group difference in the mean change in fellow-eye visual acuity (letters) from baseline to 8 weeks, adjusting for fellow-eye visual acuity at randomization. A 2-sided 99% confidence interval was computed on the adjusted treatment group difference.||0.3|-2.3|
71029580|NCT01494506|141567141|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Social Functioning||||0.6712
71029581|NCT01494506|141567141|SUPERIORITY_OR_OTHER|||||||0.6766||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Fatigue||||0.6766
71029582|NCT01494506|141567141|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Fatigue||||0.6712
71029583|NCT01494506|141567141|SUPERIORITY_OR_OTHER|||||||0.6388||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Nausea and Vomiting||||0.6388
71029584|NCT01494506|141567141|SUPERIORITY_OR_OTHER|||||||0.7674||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Nausea and Vomiting||||0.7674
71029585|NCT01494506|141567141|SUPERIORITY_OR_OTHER|||||||0.4993||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Pain||||0.4993
71029586|NCT01494506|141567141|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Pain||||0.6712
71029587|NCT01494506|141567141|SUPERIORITY_OR_OTHER|||||||0.2654||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Dyspnoea||||0.2654
71029588|NCT01494506|141567141|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Dyspnoea||||0.6712
71029589|NCT01494506|141567141|SUPERIORITY_OR_OTHER|||||||0.7617||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Insomnia||||0.7617
71029590|NCT01494506|141567141|SUPERIORITY_OR_OTHER|||||||0.6712|||||||Cochran-Mantel-Haenszel|||Comparison of Insomnia||||0.6712
71029591|NCT01494506|141567141|SUPERIORITY_OR_OTHER|||||||0.9123||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Appetite loss||||0.9123
71029592|NCT01494506|141567141|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Appetite loss||||0.6712
71029593|NCT01494506|141567141|SUPERIORITY_OR_OTHER|||||||0.7617||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Constipation||||0.7617
70968623|NCT02819635|141443069|SUPERIORITY||Adjusted risk difference (%)|15.9||||0.074|TWO_SIDED|95.0|-1.6|33.4||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||33.4|-1.6|0.074
71029594|NCT01494506|141567141|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Constipation||||0.6712
71029595|NCT01494506|141567141|SUPERIORITY_OR_OTHER|||||||0.1628||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Diarrhoea||||0.1628
71029596|NCT01494506|141567141|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Diarrhoea||||0.6712
71029597|NCT01494506|141567141|SUPERIORITY_OR_OTHER|||||||0.6388||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Financial difficulties||||0.6388
71152115|NCT02983552|141796100|SUPERIORITY|||||||0.37|||||||Fisher Exact|||Fisher's exact test was used to perform the treatment group comparison of the proportion of participants who developed a new ocular deviation and/or worsening of a pre-existing ocular deviation by 10 prism diopters at the 4-week visit.||||0.37
71029598|NCT01494506|141567141|SUPERIORITY_OR_OTHER|||||||0.7308||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Financial difficulties||||0.7308
71029599|NCT02753842|141567143|SUPERIORITY||Mean Difference (Final Values)|1.39|||<|0.05|TWO_SIDED|95.0|0.52|2.26||The a priori threshold was p\<0.05.|Mixed Models Analysis|||Comparing fitted to standard condoms, the null hypothesis was no difference in pleasure.||2.26|0.52|<0.05
71029600|NCT02753842|141567144|SUPERIORITY||Odds Ratio (OR)|1.13|||>|0.05|TWO_SIDED|95.0|0.92|1.38|||Mixed Models Analysis|||A single item assessed whether participants preferred fitted condoms or standard condoms at the end of the study (the item word viewed by participants used the blinded identifiers of each condom type).||1.38|0.92|>0.05
71029601|NCT02753842|141567146|SUPERIORITY||Odds Ratio (OR)|0.93|||>|0.05|TWO_SIDED|95.0|0.27|3.24|||logistic mixed effects model|||We assessed clinical condom failure for anal sex, comparing anal sex acts with fitted condoms to anal sex acts with standard condoms.||3.24|0.27|>0.05
71029602|NCT02753842|141567147|SUPERIORITY||Median Difference (Final Values)|1.06|||<|0.05|TWO_SIDED|95.0|0.18|1.94||The a priori threshold was p\<0.05.|Mixed Models Analysis|||Comparing thin to standard condoms, the null hypothesis was no difference in pleasure.||1.94|0.18|<0.05
71029603|NCT05216081|141567149|OTHER||Percentage of enrolled from eligible|69.4|||||TWO_SIDED|95.0|61.5|76.2||||||||76.2|61.5|
71090877|NCT02081807|141688010|OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.58|1.72|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.72|0.58|
71152116|NCT02983552|141796101|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Fisher's exact test was used to perform the treatment group comparison of the proportion of participants who developed a new ocular deviation and/or worsening of a pre-existing ocular deviation by 10 prism diopters at the 8-week visit.||||0.99
71152117|NCT02983552|141796102|SUPERIORITY|||||||0.2|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||0.20
71152118|NCT02983552|141796103|SUPERIORITY||||||>|0.99|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||>0.99
71029604|NCT05216081|141567150|OTHER||Percentage of enrolled from eligible|99.0|||||TWO_SIDED|95.0|94.7|99.8||||||||99.8|94.7|
71029605|NCT05216081|141567152|OTHER||Percentage screened positive for EM|15.8|||||TWO_SIDED|95.0|10.0|24.2||||||||24.2|10|
71029606|NCT05216081|141567155|OTHER||Percentage who self-disclosed|57.1|||||TWO_SIDED|95.0|32.6|78.6||||||||78.6|32.6|
71029607|NCT05216081|141567156|OTHER||Percentage substantiated by socialworker|75.0|||||TWO_SIDED|95.0|50.5|89.8||||||||89.8|50.5|
71029608|NCT03100903|141567170|OTHER|The statistical model was an analysis of variance (ANOVA) model on the logarithmic scale, accounting for the treatment group as a source of variation. The effect 'treatment group' was considered as fixed.|Geometric Mean ratio (%)|71.64|||||TWO_SIDED|90.0|60.57|84.73|||||"gMean ratio = gMean of BI 655130 high dose SC/gMean of BI 655130 high dose IV.~Inter-individual geometric coefficient of variation (gCV) \[%\] = 23.7"|||84.73|60.57|
71029609|NCT03100903|141567171|OTHER|The statistical model was an analysis of variance (ANOVA) model on the logarithmic scale, accounting for the treatment group as a source of variation. The effect 'treatment group' was considered as fixed.|Geometric Mean (gMean) Ratio %|29.29|||||TWO_SIDED|90.0|24.27|35.35|||||"gMean ratio = gMean of BI 655130 high dose SC/gMean of BI 655130 high dose IV.~Inter-individual geometric coefficient of variation (gCV) \[%\] = 26.6"|||35.35|24.27|
71029610|NCT03100903|141567172|OTHER|The statistical model was an analysis of variance (ANOVA) model on the logarithmic scale, accounting for the treatment group as a source of variation. The effect 'treatment group' was considered as fixed.|Geometric Mean (gMean) Ratio %|70.22|||||TWO_SIDED|90.0|59.26|83.2|||||"gMean ratio = gMean of BI 655130 high dose SC/gMean of BI 655130 high dose IV.~Inter-individual geometric coefficient of variation (gCV) \[%\] = 23.9"|||83.20|59.26|
71029611|NCT01882647|141567175|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||"Treatment groups were compared with respect to the proportions of subjects with treatment success at Day 15 using the Cochran-Mantel-Haenszel (CMH) test stratified by analysis center."|Cochran-Mantel-Haenszel|Multiple imputation was used to impute missing data from the ITT population.||||||<0.001
70968624|NCT02819635|141443069|SUPERIORITY||Adjusted risk difference (%)|19.2||||0.033|TWO_SIDED|95.0|1.6|36.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||36.9|1.6|0.033
71029612|NCT01882647|141567176|SUPERIORITY_OR_OTHER||||||<|0.001||||||The pre-specified threshold for statistical significance was ≤0.05.|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).||||<0.001
71029613|NCT01882647|141567177|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.01
71029614|NCT01882647|141567178|SUPERIORITY_OR_OTHER||||||<|0.01||||||The pre-specified threshold for statistical significance was ≤0.05.|Cochran-Mantel-Haenszel|||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).||||<0.01
71029615|NCT03311646|141567182|OTHER|A linear mixed-model was used. The model included terms for cigarette nicotine content (VLNC/NNC), time, cohort, a random effect for subject, and a nicotine content x time interaction. Interaction was dropped when nonsignificant. Reported below is the effect of nicotine content as well as the interaction p-value.|Mean Difference (Final Values)|0.07||||0.92|TWO_SIDED|95.0|-1.27|1.4||alpha=0.05.|Mixed Models Analysis||Mean Difference = VLNC-NNC|Comparison of carbon monoxide during VLNC condition to carbon monoxide during the NNC (baseline) condition.|Interaction p-value: p=0.27|1.4|-1.27|0.92
71029616|NCT03311646|141567183|OTHER|A linear mixed-model was used. The model included terms for cigarette nicotine content (VLNC/NNC), time, cohort, a random effect for subject, and a nicotine content x time interaction. Interaction was dropped when nonsignificant. Reported below is the effect of nicotine content as well as the interaction p-value.|Mean Difference (Final Values)|1.13||||0.15|TWO_SIDED|95.0|-0.41|2.66||alpha=0.05|Mixed Models Analysis||Mean Difference = VLNC-NNC|Comparison of cigarette per day during VLNC condition to cigarette per day during the NNC (baseline) condition.|Interaction p=0.23|2.66|-0.41|0.15
71029617|NCT03311646|141567184|OTHER|A linear mixed-model was used. The model included terms for cigarette nicotine content (VLNC/NNC), time, cohort, a random effect for subject, and a nicotine content x time interaction. Interaction was dropped when nonsignificant. Reported below is the effect of nicotine content as well as the interaction p-value.|Mean Difference (Final Values)|3.19|||<|0.001|TWO_SIDED|95.0|1.77|4.6|||Mixed Models Analysis||Mean Difference=VLNC-NNC|Comparison of Minnesota Nicotine Withdrawal Scale during VLNC condition to Minnesota Nicotine Withdrawal Scale during the NNC (baseline) condition.|Interaction p=0.95|4.60|1.77|<0.001
71029618|NCT03311646|141567185|OTHER|A linear mixed-model was used. The model included terms for cigarette nicotine content (VLNC/NNC), time, cohort, a random effect for subject, and a nicotine content x time interaction. Interaction was dropped when nonsignificant. Reported below is the effect of nicotine content as well as the interaction p-value.|Mean Difference (Final Values)|0.2||||0.84|TWO_SIDED|95.0|-2.0|2.5||alpha=0.05|Mixed Models Analysis||Mean Difference = VLNC-NNC|Comparison of carbon monoxide during VLNC condition to carbon monoxide during the NNC (baseline) condition.|Interaction p=0.94|2.5|-2.0|0.84
71029619|NCT01492361|141567186|SUPERIORITY||Hazard Ratio (HR)|0.75||||1e-08|TWO_SIDED|95.0|0.68|0.83||The 2-sided alpha level for the primary analysis was adjusted to 0.0437 from 0.05 to account for the two interim analyses based on a group sequential design with O'Brien-Fleming boundaries generated using the Lan-DeMets alpha-spending function.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region||||0.83|0.68|0.00000001
71029620|NCT01492361|141567187|SUPERIORITY||Hazard Ratio (HR)|0.74||||6e-07|TWO_SIDED|95.0|0.65|0.83||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.83|0.65|0.0000006
71029621|NCT01492361|141567188|SUPERIORITY||Hazard Ratio (HR)|0.75|||<|0.0001|TWO_SIDED|95.0|0.66|0.86||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.86|0.66|<0.0001
71029622|NCT01492361|141567189|SUPERIORITY||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.58|0.81||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.81|0.58|<0.0001
71029623|NCT01492361|141567190|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.55|0.78||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.78|0.55|<0.0001
71029624|NCT01492361|141567191|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0315|TWO_SIDED|95.0|0.66|0.98||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.98|0.66|0.0315
71029625|NCT01492361|141567192|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0018|TWO_SIDED|95.0|0.53|0.87||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.87|0.53|0.0018
71152119|NCT02983552|141796104|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||The exact Wilcoxon rank-sum test was used to compare the change in diplopia frequency levels from baseline to the 4-week visit by treatment group.||||0.44
71152120|NCT02983552|141796105|SUPERIORITY||||||>|0.99|||||||Wilcoxon (Mann-Whitney)|||The exact Wilcoxon rank-sum test was used to compare the change in diplopia frequency levels from baseline to the 8-week visit by treatment group.||||>0.99
71152121|NCT02983552|141796106|SUPERIORITY|||||||0.12|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||0.12
71029626|NCT01492361|141567193|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0129|TWO_SIDED|95.0|0.55|0.93||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.93|0.55|0.0129
71029627|NCT01492361|141567194|SUPERIORITY||Hazard Ratio (HR)|0.77|||<|0.0001|TWO_SIDED|95.0|0.69|0.86||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.86|0.69|<0.0001
71029628|NCT01492361|141567195|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.0915|TWO_SIDED|95.0|0.74|1.02||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||1.02|0.74|0.0915
71029629|NCT03765502|141567198|SUPERIORITY||||||<|0.0001|||||||McNemar|Crossover design: paired test||||||<.0001
71029630|NCT03765502|141567199|SUPERIORITY||||||<|0.0001|||||||McNemar|Crossover design: paired test||||||<.0001
71029631|NCT00683020|141567205|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|2.0|STANDARD_ERROR_OF_MEAN|0.9||0.03|TWO_SIDED|95.0|0.1|3.9|||Regression, Linear|Adjusted for baseline values.||||3.9|0.1|0.03
71029632|NCT00683020|141567206|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|1.2||0.23|TWO_SIDED|95.0|-0.9|3.6|||Regression, Linear|Adjusted for baseline values.||||3.6|-0.9|0.23
71152122|NCT02983552|141796107|SUPERIORITY||||||>|0.99|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||>0.99
70906989|NCT02942004|141303700|SUPERIORITY||Odds Ratio (OR)|2.5||||0.0572|TWO_SIDED|95.0|1.0|6.5|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||6.5|1.0|0.0572
71029633|NCT00683020|141567207|NON_INFERIORITY_OR_EQUIVALENCE|Days in comparison groups are not equal.|Rate Ratio|0.6||||0.25|TWO_SIDED|95.0|0.3|1.4|||Negative Binomial Models|Adjusted for baseline values.||||1.4|0.3|0.25
71029634|NCT00683020|141567208|NON_INFERIORITY_OR_EQUIVALENCE|Proportions in comparison groups are not equal.|Odds Ratio (OR)|0.5||||0.18|TWO_SIDED|95.0|0.2|1.4|||Regression, Logistic|Adjusted for baseline values.||||1.4|0.2|0.18
71029635|NCT00683020|141567209|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.1||0.008|TWO_SIDED|95.0|0.1|0.5|||Regression, Linear|Adjusted for baseline values.||||0.5|0.1|0.008
71152123|NCT02983552|141796108|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||The exact Wilcoxon rank-sum test was used to compare the change in diplopia frequency levels from baseline to the 4-week visit by treatment group.||||0.12
71152124|NCT02983552|141796109|SUPERIORITY||||||>|0.99|||||||Wilcoxon (Mann-Whitney)|||The exact Wilcoxon rank-sum test was used to compare the change in diplopia frequency levels from baseline to the 8-week visit by treatment group.||||>0.99
71152125|NCT02983552|141796112|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||For each Symptom Survey item, the exact Wilcoxon rank-sum test was used to compare the change in symptom frequency level from baseline to the 4-week visit by treatment group.||||0.07
71152126|NCT02983552|141796113|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||For each Symptom Survey item, the exact Wilcoxon rank-sum test was used to compare the change in symptom frequency level from baseline to the 8-week visit by treatment group. This was utilized for each item in the survey.||||0.06
71029636|NCT00683020|141567210|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.87|TWO_SIDED|95.0|-0.2|0.2|||Regression, Linear|Adjusted for baseline values.||||0.2|-0.2|0.87
71029637|NCT00683020|141567211|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|1.6||0.49|TWO_SIDED|95.0|-2.1|4.2|||Regression, Linear|Adjusted for baseline values.||||4.2|-2.1|0.49
71152127|NCT02983552|141796116|SUPERIORITY||||||>|0.01||||||Statistical significance of the interaction term was based on a 2-sided alpha=0.01.|ANCOVA|||An analysis of covariance (ANCOVA) was performed to test the 2-way interaction between treatment group with each factor (baseline age and visual acuity were treated as continuous factors), adjusting for baseline amblyopic-eye visual acuity and the nested terms from the interaction term. Formal subgroup analyses were only performed if there was a minimum of 20 participants in every subgroup category across both treatment groups for factors treated as categorical variables in the model.||||>0.01
71152128|NCT00976560|141796122|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|0.99|||TWO_SIDED|95.0|-2.54|1.35|||BMMRM|Bayesian Mixed Effects Model Repeated Measures (BMMRM)|Prior distribution of N(-4.1, 6.4009) incorporated into the posterior for the treatment difference at Week 6. The presented Confidence Interval is Highest Probability Density (HPD).||Posterior probability of the treatment difference being greater than 1.6 points in favor of GW856553 7.5mg BID as compared to placebo at Week 6 is 15.46 and for 0 is 72.98 and for 2 is 7.87.|1.35|-2.54|
71029638|NCT00683020|141567212|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|2.2||0.54|TWO_SIDED|95.0|-3.0|5.6|||Regression, Linear|Adjusted for baseline values.||||5.6|-3.0|0.54
71029639|NCT00683020|141567213|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|2.0|STANDARD_ERROR_OF_MEAN|1.2||0.11|TWO_SIDED|95.0|-0.4|4.4|||Regression, Linear|Adjusted for baseline values.||||4.4|-0.4|0.11
71029640|NCT00683020|141567214|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.13|TWO_SIDED|95.0|-0.6|0.1|||Regression, Linear|Adjusted for baseline values.||||0.1|-0.6|0.13
71029641|NCT00683020|141567215|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|2.3||0.78|TWO_SIDED|95.0|-3.8|5.1|||Regression, Linear|Adjusted for baseline values.||||5.1|-3.8|0.78
70906990|NCT02942004|141303700|SUPERIORITY||Odds Ratio (OR)|1.2||||0.6768|TWO_SIDED|95.0|0.5|3.0|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||3.0|0.5|0.6768
70906991|NCT02942004|141303700|SUPERIORITY||Odds Ratio (OR)|5.4||||0.0035|TWO_SIDED|95.0|1.7|16.8|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||16.8|1.7|0.0035
70906992|NCT02942004|141303700|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0347|TWO_SIDED|95.0|1.1|7.8|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||7.8|1.1|0.0347
71029642|NCT00683020|141567216|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|2.1|STANDARD_ERROR_OF_MEAN|1.4||0.13|TWO_SIDED|95.0|-0.6|4.9|||Regression, Linear|Adjusted for baseline values.||||4.9|-0.6|0.13
71029643|NCT03127137|141567231|SUPERIORITY|||||||0.05||||||The reported p-value was calculated.|Fisher Exact|||||||.05
71152129|NCT01216189|141796144|SUPERIORITY||Mean change|-0.138||||0.004|TWO_SIDED|95.0|-0.232|-0.044||The threshold for statistical significance was p = 0.05.|Regression, Linear|Model adjusted for menopausal status.||The change in serum testosterone levels between baseline and 1 year was assessed using longitudinal regression analysis (GEE).||-0.044|-0.232|0.004
70925897|NCT02761057|141345646|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.019|TWO_SIDED|95.0|0.37|0.97|||Regression, Cox|||A proportional hazards model was used to compare the Hazard Ratio (HR) for PFS.||0.97|0.37|0.019
71029644|NCT03127137|141567232|SUPERIORITY||Risk Ratio (RR)|1.53|||||TWO_SIDED|95.0|0.82|2.86||||||||2.86|.82|
71029645|NCT01249664|141567243|SUPERIORITY_OR_OTHER||Difference in least square means|14.1|||<|0.0001|TWO_SIDED|95.0|10.8|17.4||No adjustment on P value, this is for the primary efficacy analysis.|ANCOVA|ANCOVA model, including treatment groups and country (country designations) as fixed effects and baseline BCVA as a covariate.|The difference is calculated as Eylea minus Sham. A positive value indicates Eylea showed a higher change in BCVA total score until week 24 compared to Sham.|Null hypothesis was equality in change from baseline to Week 24 in BCVA total letter score between Eylea and Sham.||17.4|10.8|<0.0001
71029646|NCT01249664|141567244|SUPERIORITY_OR_OTHER||CMH adjusted difference|29.2||||0.0001|TWO_SIDED|95.0|14.4|44.0||No adjustment on P value, since this test was only conducted formally under the primary efficacy evaluation was significant.|Cochran-Mantel-Haenszel||A two-sided Cochran-Mantel-Haenszel method at level 5% weight-adjusted by country (country designations) was used to conduct the superiority test.|Null hypothesis of difference of Eylea minus Sham of 0 was tested.||44.0|14.4|0.0001
71152130|NCT01216189|141796144|SUPERIORITY||Mean change|-0.011||||0.805|TWO_SIDED|95.0|-0.097|0.075||The threshold for statistical significance was p=0.05.|Regression, Linear|Model adjusted for menopausal status.||The change in serum testosterone levels between baseline and 1 year was assessed using longitudinal regression analysis (GEE).||0.075|-0.097|0.805
71029647|NCT01249664|141567245|SUPERIORITY_OR_OTHER||Difference in least square means|13.1|||<|0.0001|TWO_SIDED|95.0|9.4|16.7|||ANCOVA|||||16.7|9.4|<0.0001
71029648|NCT01249664|141567246|SUPERIORITY_OR_OTHER||CMH adjusted difference|50.5|||<|0.001|TWO_SIDED|95.0|35.0|66.0|||Cochran-Mantel-Haenszel|||||66.0|35.0|<0.001
71029649|NCT01249664|141567247|SUPERIORITY_OR_OTHER||CMH adjusted difference|64.0|||<|0.001|TWO_SIDED|95.0|47.8|80.3|||Cochran-Mantel-Haenszel|||||80.3|47.8|<0.001
71029650|NCT01249664|141567248|SUPERIORITY_OR_OTHER||CMH adjusted difference|21.0||||0.0308|TWO_SIDED|95.0|1.9|40.1|||Cochran-Mantel-Haenszel|||||40.1|1.9|0.0308
71029651|NCT01249664|141567249|SUPERIORITY_OR_OTHER||CMH adjusted difference|27.0||||0.0075|TWO_SIDED|95.0|7.2|46.8|||Cochran-Mantel-Haenszel|||||46.8|7.2|0.0075
71029652|NCT01249664|141567250|SUPERIORITY_OR_OTHER||CMH adjusted difference|42.7|||<|0.0001|TWO_SIDED|95.0|23.7|61.6|||Cochran-Mantel-Haenszel|||||61.6|23.7|<.0001
71029653|NCT01249664|141567251|SUPERIORITY_OR_OTHER||CMH adjusted difference|-6.5||||0.1478|TWO_SIDED|95.0|-15.2|2.3|||Cochran-Mantel-Haenszel|||||2.3|-15.2|0.1478
71029654|NCT01249664|141567252|SUPERIORITY_OR_OTHER||CMH adjusted difference|-25.8||||0.0006|TWO_SIDED|95.0|-40.6|-11.0|||Cochran-Mantel-Haenszel|||||-11.0|-40.6|0.0006
71029655|NCT01249664|141567253|SUPERIORITY_OR_OTHER||CMH adjusted difference|-32.2|||<|0.0001|TWO_SIDED|95.0|-48.1|-16.3|||Cochran-Mantel-Haenszel|||||-16.3|-48.1|<0.0001
71029656|NCT01249664|141567254|SUPERIORITY_OR_OTHER||CMH adjusted difference|-5.3||||0.2446|TWO_SIDED|95.0|-14.4|3.7|||Cochran-Mantel-Haenszel|||||3.7|-14.4|0.2446
71029657|NCT01249664|141567255|SUPERIORITY_OR_OTHER||CMH adjusted difference|-21.5||||0.0035|TWO_SIDED|95.0|-35.9|-7.0|||Cochran-Mantel-Haenszel|||||-7.0|-35.9|0.0035
71029658|NCT01249664|141567256|SUPERIORITY_OR_OTHER||CMH adjusted difference|-25.7||||0.0012|TWO_SIDED|95.0|-41.3|-10.1|||Cochran-Mantel-Haenszel|||||-10.1|-41.3|0.0012
71029659|NCT01249664|141567257|SUPERIORITY_OR_OTHER||Difference in least square means|-77.9|||<|0.0001|TWO_SIDED|95.0|-108.9|-46.9|||ANCOVA|||||-46.9|-108.9|<0.0001
71029660|NCT01249664|141567258|SUPERIORITY_OR_OTHER||Difference in least square means|-29.3||||0.065|TWO_SIDED|95.0|-60.4|1.8|||ANCOVA|||||1.8|-60.4|0.0650
71029661|NCT01249664|141567259|SUPERIORITY_OR_OTHER||Difference in least square means|-0.4808|||<|0.0001|TWO_SIDED|95.0|-0.599|-0.3626|||ANCOVA|||||-0.3626|-0.5990|<0.0001
71029662|NCT01249664|141567260|SUPERIORITY_OR_OTHER||Difference in least square means|-0.1346||||0.0256|TWO_SIDED|95.0|-0.2525|-0.0167|||ANCOVA|||||-0.0167|-0.2525|0.0256
71029663|NCT01249664|141567261|SUPERIORITY_OR_OTHER||Difference in least square means|-0.0045||||0.869|TWO_SIDED|95.0|-0.0579|0.049|||ANCOVA|||||0.0490|-0.0579|0.8690
71090878|NCT02081807|141688010|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.38|1.87|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||1.87|0.38|
71090879|NCT02081807|141688012|OTHER||Hazard Ratio (HR)|0.39|||||TWO_SIDED|95.0|0.25|0.59|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.59|0.25|
71152131|NCT01216189|141796145|SUPERIORITY||Mean change in FSFI scores|-9.33||||0.013|TWO_SIDED|95.0|-16.66|-1.99||The threshold for statistical significance was p=0.05.|Regression, Linear|Model adjusted for Age, Psychological General Well-being total score and relationship with partner.||"The association between mean change in total FSFI score and preoperative RT was assessed using longitudinal regression analysis (GEE), using no preoperative radiotherapy as the reference group."||-1.99|-16.66|0.013
71029664|NCT01249664|141567262|SUPERIORITY_OR_OTHER||Difference of least square means|5.21||||0.0104|TWO_SIDED|95.0|1.25|9.18|||ANCOVA|||||9.18|1.25|0.0104
71029665|NCT01249664|141567264|SUPERIORITY_OR_OTHER||Difference in least square means|-0.6648|||<|0.0001|TWO_SIDED|95.0|-0.8056|-0.5239|||ANCOVA|||||-0.5239|-0.8056|<0.0001
71029666|NCT01682083|141567265|SUPERIORITY|Hazard ratio is obtained from the stratified Pike estimator. A hazard ratio \<1 indicates a lower risk with Dabrafenib + Trametinib compared with Placebo.|Hazard Ratio, log|0.47|||<|0.0001|TWO_SIDED|95.0|0.39|0.58|||Log Rank|||The null hypothesis, H0: λ = 1 or reject it in favor of the alternative hypothesis, HA: λ ≠ 1, where λ is the hazard ratio (HR) of combination therapy relative to placebo.||0.58|0.39|< 0.0001
71090880|NCT02081807|141688012|OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.51|0.95|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||0.95|0.51|
71029667|NCT01682083|141567266|SUPERIORITY|A hazard ratio \<1 indicates a lower risk with dabrafenib + trametinib compared with Placebo.|Hazard Ratio, log|0.57||||0.006|TWO_SIDED|95.0|0.42|0.79|||Log Rank|the two-sided threshold for significance at this first interim analysis was p=0.000019||Hazard ratio is obtained from the stratified Pike estimator.||0.79|0.42|0.006
71029668|NCT01682083|141567267|SUPERIORITY|A hazard ratio \<1 indicates a lower risk with Dabrafenib + Trametinib compared with Placebo.|Hazard Ratio, log|0.51|||||TWO_SIDED|95.0|0.4|0.65||||||Hazard ratio is estimated using Pike estimator.||0.65|0.40|
71029669|NCT01682083|141567268|SUPERIORITY|A hazard ratio \<1 indicates a lower risk with Dabrafenib + Trametinib compared with Placebo.|Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.39|0.57||||||Hazard ratio is estimated using Pike estimator.||0.57|0.39|
71029670|NCT01239121|141567270|SUPERIORITY_OR_OTHER||Slope|0.6||||0.175|TWO_SIDED|95.0|-0.27|1.5|||Regression, Linear|||||1.5|-0.27|0.175
71029671|NCT01239121|141567271|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.964|TWO_SIDED|95.0|0.49|2.1|||Regression, Logistic|||||2.1|.49|0.964
71029672|NCT01014728|141567273|SUPERIORITY_OR_OTHER|||||||0.937||95.0|||||t-test, 2 sided|||||||0.937
71029673|NCT01014728|141567274|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
71029674|NCT01014728|141567275|SUPERIORITY_OR_OTHER|||||||0.461||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.461
71029675|NCT01050647|141567300|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||0.31
71029676|NCT01050647|141567301|SUPERIORITY||||||>|0.99|||||||Chi-squared|||||||>0.99
71029677|NCT01050647|141567302|SUPERIORITY|||||||0.59|||||||Chi-squared|||||||0.59
71029678|NCT01050647|141567303|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
71029679|NCT01050647|141567304|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
71029680|NCT03657160|141567421|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|0.001|TWO_SIDED|95.0|0.27|0.73|||Log Rank|||||0.73|0.27|<0.001
71029681|NCT03657160|141567422|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.0043|TWO_SIDED|95.0|0.37|0.86|||Log Rank|||||0.86|0.37|0.0043
71029682|NCT03657160|141567423|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.0204|TWO_SIDED|95.0|0.39|0.91|||Log Rank|||||0.91|0.39|0.0204
71029683|NCT03657160|141567424|SUPERIORITY||Hazard Ratio (HR)|0.48||||0.0668|TWO_SIDED|95.0|0.22|1.04|||Log Rank|||||1.04|0.22|0.0668
71029684|NCT03657160|141567425|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.1458|TWO_SIDED|95.0|0.34|1.17|||Log Rank|||||1.17|0.34|0.1458
71029685|NCT03657160|141567426|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.0105|TWO_SIDED|95.0|0.46|0.91|||Log Rank|||||0.91|0.46|0.0105
71029686|NCT04638153|141567437|OTHER||least square mean difference|0.2|||||TWO_SIDED|95.0|-0.2|0.6|||||Month 3|Results based on Mixed-Effect Repeated Measures (MMRM) analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.6|-0.2|
71029687|NCT04638153|141567437|OTHER||Least square mean difference|0.5|||||TWO_SIDED|95.0|0.1|0.9|||||Month 3|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.9|0.1|
71029688|NCT04638153|141567437|OTHER||Least square mean difference|-0.3|||||TWO_SIDED|95.0|-0.7|0.1|||||Month 3|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.1|-0.7|
71029689|NCT04638153|141567437|OTHER||Least square mean difference|-0.1|||||TWO_SIDED|95.0|-0.4|0.1|||||Month 6|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.1|-0.4|
71029690|NCT04638153|141567437|OTHER||Least square mean difference|-0.1|||||TWO_SIDED|95.0|-0.4|0.2|||||Month 6|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-0.4|
71029691|NCT04638153|141567437|OTHER||Least square mean difference|-0.1|||||TWO_SIDED|95.0|-0.4|0.2|||||Month 6|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-0.4|
71029692|NCT04638153|141567437|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.2|0.2|||||Month 9|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-0.2|
70925898|NCT02761057|141345647|SUPERIORITY|||||||0.1|||||||Chi-squared|||The Chi-Square test will be used to compare RR between sunitinib and cabozantinib.||||0.10
71029693|NCT04638153|141567437|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.2|0.2|||||Month 9|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-0.2|
71029694|NCT04638153|141567437|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.2|0.2|||||Month 9|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-0.2|
71029695|NCT04638153|141567437|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.2|0.2|||||Month 12|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-0.2|
71029696|NCT04638153|141567437|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.2|0.3|||||Month 12|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.3|-0.2|
71029697|NCT04638153|141567437|OTHER||Least square mean difference|-0.1|||||TWO_SIDED|95.0|-0.4|0.1|||||Month 12|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.1|-0.4|
71029698|NCT04638153|141567447|OTHER||Least square mean difference|0.3|||||TWO_SIDED|95.0|-0.5|1.2|||||Month 3|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||1.2|-0.5|
71029699|NCT04638153|141567447|OTHER||Least square mean difference|1.0|||||TWO_SIDED|95.0|0.2|1.8|||||Month 3|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||1.8|0.2|
71029700|NCT04638153|141567447|OTHER||Least square mean difference|-0.7|||||TWO_SIDED|95.0|-1.5|0.1|||||Month 3|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||0.1|-1.5|
71029701|NCT04638153|141567447|OTHER||Least square mean difference|-0.5|||||TWO_SIDED|95.0|-1.6|0.6|||||Month 6|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||0.6|-1.6|
71029702|NCT04638153|141567447|OTHER||Least square mean difference|0.7|||||TWO_SIDED|95.0|-0.4|1.9|||||Month 6|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||1.9|-0.4|
71029703|NCT04638153|141567447|OTHER||Least square mean difference|-1.2|||||TWO_SIDED|95.0|-2.3|-0.1|||||Month 6|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||-0.1|-2.3|
71029704|NCT04638153|141567447|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.8|0.7|||||Month 9|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||0.7|-0.8|
71029705|NCT04638153|141567447|OTHER||Least square mean difference|0.6|||||TWO_SIDED|95.0|-0.2|1.5|||||Month 9|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||1.5|-0.2|
71029706|NCT04638153|141567447|OTHER||Least square mean difference|-0.7|||||TWO_SIDED|95.0|-1.5|0.2|||||Month 9|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-1.5|
71029707|NCT04638153|141567447|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-1.3|1.5|||||Month 12|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||1.5|-1.3|
71029708|NCT04638153|141567447|OTHER||Least square mean difference|0.7|||||TWO_SIDED|95.0|-1.4|2.8|||||Month 12|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||2.8|-1.4|
70925899|NCT02761057|141345648|SUPERIORITY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.47|1.51|||Log Rank|||The log-rank test will be used to compare OS.||1.51|0.47|
71029709|NCT04638153|141567447|OTHER||Least square mean difference|-0.6|||||TWO_SIDED|95.0|-2.6|1.4|||||Month 12|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||1.4|-2.6|
71029710|NCT04006171|141567459|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
71029711|NCT04006171|141567460|OTHER|||||||0.004|||||||Roc curve|||||||0.004
71029712|NCT04006171|141567461|OTHER|||||||0.171||||||p value for FSH|Wilcoxon (Mann-Whitney)|for FSH||||||0.171
71029713|NCT04006171|141567461|OTHER|||||||0.176||||||p value for LH|Wilcoxon (Mann-Whitney)|for LH||||||0.176
70906993|NCT02942004|141303701|SUPERIORITY||Odds Ratio (OR)|6.0||||0.0011|TWO_SIDED|95.0|2.1|17.8|||GEE method|||Hour 60: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||17.8|2.1|0.0011
70906994|NCT02942004|141303701|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0828|TWO_SIDED|95.0|0.9|7.6|||GEE method|||Hour 60: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||7.6|0.9|0.0828
70906995|NCT02942004|141303701|SUPERIORITY||Odds Ratio (OR)|1.2||||0.7749|TWO_SIDED|95.0|0.4|3.1|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||3.1|0.4|0.7749
71029714|NCT04006171|141567462|OTHER|||||||0.306|||||||Wilcoxon (Mann-Whitney)|||||||0.306
70906996|NCT02942004|141303701|SUPERIORITY||Odds Ratio (OR)|0.6||||0.3401|TWO_SIDED|95.0|0.2|1.7|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||1.7|0.2|0.3401
70906997|NCT02942004|141303701|SUPERIORITY||Odds Ratio (OR)|2.3||||0.1052|TWO_SIDED|95.0|0.8|6.0|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||6.0|0.8|0.1052
71029715|NCT04006171|141567463|OTHER|||||||0.795|||||||Wilcoxon (Mann-Whitney)|||||||0.795
71029716|NCT04006171|141567464|OTHER|||||||0.852|||||||t-test, 2 sided|||||||0.852
71029717|NCT04006171|141567465|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71029718|NCT04006171|141567466|OTHER|||||||0.277|||||||Wilcoxon (Mann-Whitney)|||||||0.277
71029719|NCT04006171|141567467|OTHER|||||||0.006|||||||t-test, 2 sided|||||||0.006
71029720|NCT04006171|141567468|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71029721|NCT04006171|141567469|OTHER|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
71090881|NCT02081807|141688012|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.43|1.03|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||1.03|0.43|
71090882|NCT02081807|141688013|OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.67|0.84|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.84|0.67|
71029722|NCT04006171|141567470|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71029723|NCT04006171|141567471|OTHER|||||||0.947||||||for serum glucose|Wilcoxon (Mann-Whitney)|for serum glucose||||||0.947
71029724|NCT04006171|141567471|OTHER|||||||0.906||||||for total cholesterol|Wilcoxon (Mann-Whitney)|for total cholesterol||||||0.906
71029725|NCT04006171|141567471|OTHER|||||||0.428||||||for triglycerides|Wilcoxon (Mann-Whitney)|for triglycerides||||||0.428
71029726|NCT04006171|141567472|OTHER|||||||0.114||||||for high density lipoprotein|t-test, 2 sided|||||||0.114
71029727|NCT04006171|141567472|OTHER|||||||0.504||||||for low density lipoprotein|Wilcoxon (Mann-Whitney)|for low density lipoprotein||||||0.504
71029728|NCT04006171|141567473|OTHER|||||||0.713|||||||Wilcoxon (Mann-Whitney)|||||||0.713
71029729|NCT04006171|141567474|OTHER|||||||0.886|||||||Wilcoxon (Mann-Whitney)|||||||0.886
71029730|NCT06354270|141567483|SUPERIORITY||Adjusted Mean Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.111|<|0.0001|TWO_SIDED|95.0|-1.29|-0.85|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|||-0.85|-1.29|<0.0001
71029731|NCT06354270|141567484|SUPERIORITY||Adjusted Mean Difference|36.72|STANDARD_ERROR_OF_MEAN|3.319|<|0.0001|TWO_SIDED|95.0|30.14|43.29|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|||43.29|30.14|<0.0001
71029732|NCT06354270|141567485|SUPERIORITY||Adjusted Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.083|<|0.0001|TWO_SIDED|95.0|-0.79|-0.46|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|||-0.46|-0.79|<0.0001
71029733|NCT06354270|141567486|SUPERIORITY||Adjusted Mean Difference|14.31|STANDARD_ERROR_OF_MEAN|2.128|<|0.0001|TWO_SIDED|95.0|10.09|18.52|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|||18.52|10.09|<0.0001
71029734|NCT06354270|141567487|SUPERIORITY||Adjusted Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.252||0.196|TWO_SIDED|95.0|-0.83|0.17|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Q7 (How intense are the sensations?): Change from Baseline at Day 28||0.17|-0.83|0.1960
70906998|NCT02942004|141303701|SUPERIORITY||Odds Ratio (OR)|1.6||||0.3507|TWO_SIDED|95.0|0.6|4.2|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||4.2|0.6|0.3507
70906999|NCT02942004|141303702|SUPERIORITY||LS mean difference|-12.07|STANDARD_ERROR_OF_MEAN|4.294||0.0058|TWO_SIDED|95.0|-20.58|-3.56|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.||-3.56|-20.58|0.0058
70907000|NCT02942004|141303702|SUPERIORITY||LS mean difference|-5.89|STANDARD_ERROR_OF_MEAN|4.188||0.1622|TWO_SIDED|95.0|-14.19|2.41|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.||2.41|-14.19|0.1622
70907001|NCT02942004|141303702|SUPERIORITY||LS mean difference|-9.09|STANDARD_ERROR_OF_MEAN|4.51||0.0462|TWO_SIDED|95.0|-18.02|-0.16|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.||-0.16|-18.02|0.0462
70907002|NCT02942004|141303702|SUPERIORITY||LS mean difference|-2.24|STANDARD_ERROR_OF_MEAN|4.41||0.6124|TWO_SIDED|95.0|-10.97|6.49|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.||6.49|-10.97|0.6124
70907003|NCT02942004|141303702|SUPERIORITY||LS mean difference|-11.68|STANDARD_ERROR_OF_MEAN|4.556||0.0116|TWO_SIDED|95.0|-20.71|-2.66|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.||-2.66|-20.71|0.0116
70907004|NCT02942004|141303702|SUPERIORITY||LS mean difference|-8.26|STANDARD_ERROR_OF_MEAN|4.464||0.0667|TWO_SIDED|95.0|-17.1|0.58|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.||0.58|-17.10|0.0667
70907005|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.191||0.9681|TWO_SIDED|95.0|-0.39|0.37|||MMRM|||Depressed Mood, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.39|0.9681
70907006|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.185||0.6337|TWO_SIDED|95.0|-0.28|0.46|||MMRM|||Depressed Mood, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.28|0.6337
71152132|NCT00125164|141796147|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.79|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001||95.0|1.19|2.39||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||2.39|1.19|<0.0001
70907007|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.238||0.469|TWO_SIDED|95.0|-0.64|0.3|||MMRM|||Depressed Mood, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.64|0.4690
70968625|NCT02819635|141443069|SUPERIORITY||Adjusted risk difference (%)|40.1|||<|0.001|TWO_SIDED|95.0|20.5|59.7||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||59.7|20.5|<0.001
71029735|NCT06354270|141567487|SUPERIORITY||Adjusted Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.344||0.2287|TWO_SIDED|95.0|-1.08|0.28|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Q7 (How intense are the sensations?): Change from Baseline at Day 56||0.28|-1.08|0.2287
70907008|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.232||0.9905|TWO_SIDED|95.0|-0.46|0.46|||MMRM|||Depressed Mood, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.46|0.9905
70907009|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.3984|TWO_SIDED|95.0|-0.68|0.27|||MMRM|||Depressed Mood, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.68|0.3984
70907010|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.234||0.7042|TWO_SIDED|95.0|-0.37|0.55|||MMRM|||Depressed Mood, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.55|-0.37|0.7042
70907011|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.247||0.4941|TWO_SIDED|95.0|-0.66|0.32|||MMRM|||Depressed Mood, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.66|0.4941
70907012|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.24||0.4572|TWO_SIDED|95.0|-0.3|0.65|||MMRM|||Depressed Mood, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.65|-0.30|0.4572
70907013|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.236||0.9866|TWO_SIDED|95.0|-0.47|0.46|||MMRM|||Depressed Mood, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.47|0.9866
70907014|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.229||0.749|TWO_SIDED|95.0|-0.53|0.38|||MMRM|||Depressed Mood, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.38|-0.53|0.7490
70907015|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.247||0.0235|TWO_SIDED|95.0|-1.06|-0.08|||MMRM|||Depressed Mood, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.08|-1.06|0.0235
70907016|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.239||0.9286|TWO_SIDED|95.0|-0.5|0.45|||MMRM|||Depressed Mood, Change Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.45|-0.50|0.9286
70968626|NCT02819635|141443070|SUPERIORITY||LS Mean Difference|-2.142|||<|0.001|TWO_SIDED|95.0|-3.2323|-1.052||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|ANCOVA|Stratified by previous biologic use, Baseline corticosteroid use, Baseline Adapted Mayo score (\<= 7 and \> 7)), and Baseline value as covariate.|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||-1.0520|-3.2323|<0.001
70968627|NCT02819635|141443070|SUPERIORITY||LS Mean Difference|-2.938|||<|0.001|TWO_SIDED|95.0|-4.0284|-1.8478||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|ANCOVA|Stratified by previous biologic use, Baseline corticosteroid use, Baseline Adapted Mayo score (\<= 7 and \> 7)), and Baseline value as covariate.|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||-1.8478|-4.0284|<0.001
71090883|NCT02081807|141688013|OTHER||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.97|1.16|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.16|0.97|
71152133|NCT00125164|141796147|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.58|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001||95.0|1.99|3.16||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||3.16|1.99|< 0.0001
70907017|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.251||0.0544|TWO_SIDED|95.0|-0.99|0.01|||MMRM|||Depressed Mood, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.99|0.0544
70907018|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.244||0.2903|TWO_SIDED|95.0|-0.74|0.22|||MMRM|||Depressed Mood, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.74|0.2903
70907019|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.71|STANDARD_ERROR_OF_MEAN|0.244||0.0044|TWO_SIDED|95.0|-1.19|-0.23|||MMRM|||Depressed Mood, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.23|-1.19|0.0044
70907020|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.238||0.1339|TWO_SIDED|95.0|-0.83|0.11|||MMRM|||Depressed Mood, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.83|0.1339
70907021|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.234||0.0149|TWO_SIDED|95.0|-1.04|-0.11|||MMRM|||Depressed Mood, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.11|-1.04|0.0149
70907022|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.228||0.3213|TWO_SIDED|95.0|-0.68|0.22|||MMRM|||Depressed Mood, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.68|0.3213
70907023|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.246||0.0703|TWO_SIDED|95.0|-0.94|0.04|||MMRM|||Depressed Mood, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.94|0.0703
70907024|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.24||0.8152|TWO_SIDED|95.0|-0.53|0.42|||MMRM|||Depressed Mood, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.42|-0.53|0.8152
71029736|NCT06354270|141567487|SUPERIORITY||Adjusted Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.28||0.235|TWO_SIDED|95.0|-0.89|0.22|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Q8 (How bothered are you by any sensations?): Change from Baseline at Day 28||0.22|-0.89|0.2350
71152134|NCT00125164|141796147|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.79|STANDARD_ERROR_OF_MEAN|0.26||0.0032||95.0|0.27|1.31|||ANCOVA|||The analysis compares the 80 and 120 µg/kg BID groups using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||1.31|0.27|0.0032
70907025|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.301||0.0805|TWO_SIDED|95.0|-1.13|0.07|||MMRM|||Depressed Mood, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-1.13|0.0805
70907026|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.291||0.6964|TWO_SIDED|95.0|-0.69|0.46|||MMRM|||Depressed Mood, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.69|0.6964
71029737|NCT06354270|141567487|SUPERIORITY||Adjusted Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.328||0.1818|TWO_SIDED|95.0|-1.09|0.21|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Q8 (How bothered are you by any sensations?): Change from Baseline at Day 56||0.21|-1.09|0.1818
70907027|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.304||0.2998|TWO_SIDED|95.0|-0.92|0.29|||MMRM|||Depressed Mood, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.92|0.2998
71152135|NCT00125164|141796148|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|0.24|0.5||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||0.50|0.24|< 0.0001
70907028|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.291||0.3448|TWO_SIDED|95.0|-0.85|0.3|||MMRM|||Depressed Mood, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.85|0.3448
71029738|NCT06354270|141567487|SUPERIORITY||Adjusted Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.357||0.1316|TWO_SIDED|95.0|-1.25|0.17|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Q9 (How well can you tolerate sensations?): Change from Baseline at Day 28||0.17|-1.25|0.1316
71029739|NCT06354270|141567487|SUPERIORITY||Adjusted Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.417||0.0658|TWO_SIDED|95.0|-1.6|0.05|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Q9 (How well can you tolerate sensations?): Change from Baseline at Day 56||0.05|-1.60|0.0658
71029740|NCT06354270|141567488|SUPERIORITY||Adjusted Mean Difference|1.19|STANDARD_ERROR_OF_MEAN|4.862||0.8072|TWO_SIDED|95.0|-8.45|10.83|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||10.83|-8.45|0.8072
71152136|NCT00125164|141796148|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.47|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|0.34|0.6||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||0.60|0.34|< 0.0001
71152137|NCT00125164|141796148|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.11|STANDARD_ERROR_OF_MEAN|0.05||0.0495||95.0|0.0|0.22|||ANCOVA|||The analysis compares the 80 and 120 µg/kg BID groups using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||0.22|0.00|0.0495
71152138|NCT00125164|141796156|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.83|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001||95.0|1.26|2.4||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||2.40|1.26|<0.0001
70907029|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.248||0.0089|TWO_SIDED|95.0|-1.15|-0.17|||MMRM|||Depressed Mood, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.17|-1.15|0.0089
71029741|NCT06354270|141567488|SUPERIORITY||Adjusted Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|6.175||0.9641|TWO_SIDED|95.0|-11.96|12.52|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||12.52|-11.96|0.9641
71029742|NCT06354270|141567489|SUPERIORITY||Adjusted Mean Difference|0.86|STANDARD_ERROR_OF_MEAN|0.75||0.2538|TWO_SIDED|95.0|-0.63|2.35|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||2.35|-0.63|0.2538
71029743|NCT06354270|141567489|SUPERIORITY||Adjusted Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.922||0.7311|TWO_SIDED|95.0|-2.15|1.51|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||1.51|-2.15|0.7311
71029744|NCT06354270|141567490|SUPERIORITY||Adjusted Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|2.162||0.7202|TWO_SIDED|95.0|-3.51|5.06|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||5.06|-3.51|0.7202
71152139|NCT00125164|141796156|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.83|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001||95.0|2.26|3.39||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||3.39|2.26|<0.0001
71152140|NCT00125164|141796156|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.01|STANDARD_ERROR_OF_MEAN|0.25||0.0002||95.0|0.5|1.51|||ANCOVA|||The analysis compares the 80 and 120 µg/kg BID groups using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||1.51|0.50|0.0002
71152141|NCT00125164|141796157|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|0.25|0.5||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||0.50|0.25|<0.0001
71152142|NCT00125164|141796157|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.52|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|0.39|0.64||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||0.64|0.39|<0.0001
71152143|NCT00125164|141796157|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.06||0.0071||95.0|0.04|0.26|||ANCOVA|||The analysis compares the 80 and 120 µg/kg BID groups using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||0.26|0.04|0.0071
70968628|NCT02819635|141443070|SUPERIORITY||LS Mean Difference|-3.736|||<|0.001|TWO_SIDED|95.0|-4.8247|-2.647||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|ANCOVA|Stratified by previous biologic use, Baseline corticosteroid use, Baseline Adapted Mayo score (\<= 7 and \> 7)), and Baseline value as covariate.|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||-2.6470|-4.8247|<0.001
71152144|NCT02637037|141796173|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.96|||||TWO_SIDED|90.0|0.93|0.99||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.||0.99|0.93|
71152145|NCT02637037|141796173|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.99|||||TWO_SIDED|90.0|0.96|1.01||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.||1.01|0.96|
71152146|NCT02637037|141796173|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.97|||||TWO_SIDED|90.0|0.94|1.0||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.||1.00|0.94|
71152147|NCT02637037|141796173|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.98|||||TWO_SIDED|90.0|0.95|1.0||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.||1.00|0.95|
71152148|NCT02637037|141796173|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.01|||||TWO_SIDED|90.0|0.96|1.06||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.||1.06|0.96|
70907030|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.244||0.0772|TWO_SIDED|95.0|-0.92|0.05|||MMRM|||Depressed Mood, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.92|0.0772
70907031|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.191||0.6809|TWO_SIDED|95.0|-0.46|0.3|||MMRM|||Feelings of Guilt, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.46|0.6809
71029745|NCT06354270|141567490|SUPERIORITY||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|2.532||0.9859|TWO_SIDED|95.0|-5.06|4.98|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||4.98|-5.06|0.9859
71152149|NCT02637037|141796173|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.0|||||TWO_SIDED|90.0|0.93|1.07||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.||1.07|0.93|
71152150|NCT02637037|141796173|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.05|||||TWO_SIDED|90.0|0.99|1.11||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.||1.11|0.99|
71090884|NCT02081807|141688013|OTHER||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.47|0.63|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.63|0.47|
71090885|NCT02081807|141688014|OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.77|1.04|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||1.04|0.77|
71090886|NCT02081807|141688014|OTHER||Hazard Ratio (HR)|1.21|||||TWO_SIDED|95.0|1.07|1.36|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.36|1.07|
71090887|NCT02081807|141688014|OTHER||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.48|0.72|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.72|0.48|
71090888|NCT02081807|141688015|OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.44|0.8|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.80|0.44|
71090889|NCT02081807|141688015|OTHER||Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|0.98|1.57|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.57|0.98|
71090890|NCT02081807|141688015|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.54|1.14|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||1.14|0.54|
71090891|NCT02081807|141688016|OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.79|1.08|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||1.08|0.79|
71090892|NCT02081807|141688016|OTHER||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|1.05|1.35|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.35|1.05|
71090893|NCT02081807|141688016|OTHER||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.44|0.67|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.67|0.44|
71090894|NCT02081807|141688018|OTHER||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.59|78.0|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||078|0.59|
71090895|NCT02081807|141688018|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.93|1.16|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.16|0.93|
71090896|NCT02081807|141688018|OTHER||Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.47|0.67|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.67|0.47|
71090897|NCT02081807|141688019|OTHER||Hazard Ratio (HR)|0.53|||||TWO_SIDED|95.0|0.34|0.82|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.82|0.34|
71152151|NCT02637037|141796173|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.03|||||TWO_SIDED|90.0|0.96|1.1||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.||1.10|0.96|
71152152|NCT02637037|141796174|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.96|||||TWO_SIDED|90.0|0.94|0.99||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.||0.99|0.94|
71090898|NCT02081807|141688019|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.55|1.29|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.29|0.55|
71152153|NCT02637037|141796174|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.99|||||TWO_SIDED|90.0|0.97|1.02||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.||1.02|0.97|
71152154|NCT02637037|141796174|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.96|||||TWO_SIDED|90.0|0.93|0.98||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.||0.98|0.93|
71152155|NCT02637037|141796174|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.97|||||TWO_SIDED|90.0|0.95|1.0||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.||1.00|0.95|
71152156|NCT02637037|141796174|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.02|||||TWO_SIDED|90.0|0.97|1.08||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.||1.08|0.97|
71152157|NCT02637037|141796174|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.01|||||TWO_SIDED|90.0|0.95|1.06||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.||1.06|0.95|
71152158|NCT02637037|141796174|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of geometric means|1.03|||||TWO_SIDED|90.0|0.97|1.09||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.||1.09|0.97|
71152159|NCT02637037|141796174|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.01|||||TWO_SIDED|90.0|0.95|1.07||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.||1.07|0.95|
71152160|NCT02637037|141796175|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.98|||||TWO_SIDED|90.0|0.93|1.03||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.||1.03|0.93|
71152161|NCT02637037|141796175|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.97|||||TWO_SIDED|90.0|0.9|1.06||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.||1.06|0.90|
71152162|NCT02637037|141796175|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.97|||||TWO_SIDED|90.0|0.89|1.05||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.||1.05|0.89|
71008700|NCT02055976|141525244|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|13.389|STANDARD_ERROR_OF_MEAN|2.525|<|0.001|TWO_SIDED|95.0|8.373|18.405|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||18.405|8.373|<0.001
71152163|NCT02637037|141796175|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.95|||||TWO_SIDED|90.0|0.87|1.03||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.||1.03|0.87|
71152164|NCT02637037|141796175|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.01|||||TWO_SIDED|90.0|0.96|1.07||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.||1.07|0.96|
71152165|NCT02637037|141796175|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.98|||||TWO_SIDED|90.0|0.92|1.04||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.||1.04|0.92|
71152166|NCT02637037|141796175|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of geometric means|1.0|||||TWO_SIDED|90.0|0.95|1.06||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.||1.06|0.95|
71152167|NCT02637037|141796175|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.02|||||TWO_SIDED|90.0|0.94|1.1||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.||1.10|0.94|
71152168|NCT01469377|141796194|SUPERIORITY||Least squares mean difference|-0.9||||0.2404|TWO_SIDED|95.0|-2.4|0.6||p-values were from an mixed-effects model for repeated measures with treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Mixed-effect model for repeated measures|p-values were adjusted for multiple comparisons using the matched parallel gate-keeping procedure.||||0.6|-2.4|0.2404
71152169|NCT01469377|141796194|SUPERIORITY||Least squares mean difference|-2.2||||0.0114|TWO_SIDED|95.0|-3.7|-0.6||p-values were from an mixed-effects model for repeated measures with treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Mixed-effect model for repeated measures|p-values were adjusted for multiple comparisons using the matched parallel gate-keeping procedure.||||-0.6|-3.7|0.0114
71152170|NCT01469377|141796195|SUPERIORITY||Least squares mean difference|-1.1||||0.2404|TWO_SIDED|95.0|-2.5|0.3||p-values were from an mixed-effects model for repeated measures with treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Mixed-effect model for repeated measures|p-values were adjusted for multiple comparisons using the matched parallel gate-keeping procedure.||||0.3|-2.5|0.2404
71152171|NCT01469377|141796195|SUPERIORITY||Least squares mean difference|-1.4||||0.114|TWO_SIDED|95.0|-2.8|0.0||p-values were from an mixed-effects model for repeated measures with treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Mixed-effect model for repeated measures|p-values were adjusted for multiple comparisons using the matched parallel gate-keeping procedure.||||0.0|-2.8|0.1140
71152172|NCT04308291|141796222|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|paired t-test||||||<0.0001
71152173|NCT01354314|141796264|SUPERIORITY|||||||0.893|||||||Regression, Linear|||||||0.893
71152174|NCT01354314|141796264|SUPERIORITY|||||||0.594|||||||Regression, Linear|||||||0.594
71152175|NCT01354314|141796264|SUPERIORITY|||||||0.712|||||||Regression, Linear|||||||0.712
71152176|NCT01354314|141796265|SUPERIORITY|||||||0.673|||||||Regression, Linear|||||||0.673
71029746|NCT06354270|141567491|SUPERIORITY||Adjusted Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.78||0.5586|TWO_SIDED|95.0|-2.0|1.09|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||1.09|-2.00|0.5586
71152177|NCT01354314|141796265|SUPERIORITY|||||||0.153|||||||Regression, Linear|||||||0.153
71152178|NCT01354314|141796265|SUPERIORITY|||||||0.282|||||||Regression, Linear|||||||0.282
71152179|NCT01354314|141796266|SUPERIORITY|||||||0.327|||||||Regression, Linear|||||||0.327
71152180|NCT01354314|141796266|SUPERIORITY|||||||0.178|||||||Regression, Linear|||||||0.178
71152181|NCT01354314|141796266|SUPERIORITY|||||||0.48|||||||Regression, Linear|||||||0.480
71152182|NCT01354314|141796267|SUPERIORITY|||||||0.267|||||||Regression, Linear|||||||0.267
71152183|NCT01354314|141796267|SUPERIORITY|||||||0.368|||||||Regression, Linear|||||||0.368
71152184|NCT01354314|141796267|SUPERIORITY|||||||0.672|||||||Regression, Linear|||||||0.672
71152185|NCT00478023|141796300|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|18.1|||<|0.0001||95.0|10.9|25.3||Adjusted. The Hochberg procedure used for multiplicity comparisons|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 24 hours (SPID24). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID24.||25.3|10.9|<0.0001
71152186|NCT00478023|141796300|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|20.8|||<|0.0001||95.0|13.7|28.0||Adjusted. The Hochberg procedure used for multiplicity comparisons|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 24 hours (SPID24). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID24.||28.0|13.7|<0.0001
71152187|NCT00478023|141796300|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|23.3|||<|0.0001||95.0|16.3|30.4||Adjusted. The Hochberg procedure used for multiplicity comparisons.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 24 hours (SPID24). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID24.||30.4|16.3|<0.0001
71090899|NCT02081807|141688019|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.41|1.42|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||1.42|0.41|
71090900|NCT02081807|141688020|OTHER||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.6|1.15|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||1.15|0.60|
71090901|NCT02081807|141688020|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.63|1.14|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.14|0.63|
71090902|NCT02081807|141688020|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.53|1.18|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||1.18|0.53|
71090903|NCT02081807|141688021|OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.5|0.84|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.84|0.50|
71090904|NCT02081807|141688021|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.69|1.01|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Rivaroxaban vs. Warfarin (as reference group).||1.01|0.69|
71090905|NCT02081807|141688021|OTHER||Hazard Ratio (HR)|0.53|||||TWO_SIDED|95.0|0.37|0.76|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.76|0.37|
71090906|NCT02081807|141688022|OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.47|0.88|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.88|0.47|
71090907|NCT02081807|141688022|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.65|1.04|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.04|0.65|
71090908|NCT02081807|141688022|OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.39|0.92|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.92|0.39|
71090909|NCT02081807|141688023|OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.47|1.04|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Dabigatran vs. Warfarin (as reference group).||1.04|0.47|
71090910|NCT02081807|141688023|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.6|1.05|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.05|0.60|
71090911|NCT02081807|141688023|OTHER||Hazard Ratio (HR)|0.42|||||TWO_SIDED|95.0|0.24|0.73|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.73|0.24|
71090912|NCT00091819|141688045|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 10% was specified based on historical regulatory precedent.|Risk Difference (RD)|1.0||||||95.0|-4.8|6.8||p-values were not calculated in deference to confidence intervals.|||"Statistical analysis applies to cure"|||6.8|-4.8|
71090913|NCT00961415|141688046|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.37|0.69|||Log Rank|||||0.69|0.37|<0.001
71090914|NCT00961415|141688047|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.23|TWO_SIDED|95.0|0.47|1.2|||Log Rank|||||1.20|0.47|0.230
71090915|NCT00961415|141688049|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53||||0.006|TWO_SIDED|95.0|0.34|0.84|||Log Rank|||||0.84|0.34|0.006
71090916|NCT00961415|141688050|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.38|0.7|||Log Rank|||||0.70|0.38|<0.001
71090917|NCT03692312|141688155|SUPERIORITY||Mean Difference (Final Values)|1.75|STANDARD_ERROR_OF_MEAN|0.875||0.0514|TWO_SIDED|95.0|-0.01|3.51|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||3.51|-0.01|0.0514
71090918|NCT03692312|141688156|SUPERIORITY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.268||0.2124|TWO_SIDED|95.0|-0.2|0.88|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||0.88|-0.20|0.2124
71152188|NCT00478023|141796300|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|20.6|||<|0.0001||95.0|13.4|27.8||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|Null hypothesis of no treatment difference.||27.8|13.4|<0.0001
71152189|NCT00478023|141796301|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|37.1|||<|0.0001||95.0|21.6|52.6||Adjusted. The Hochberg procedure used for multiplicity comparisons.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 48 hours (SPID48). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID48.||52.6|21.6|<0.0001
71152190|NCT00478023|141796301|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|44.0|||<|0.0001||95.0|28.6|59.5||Adjusted. The Hochberg procedure used for multiplicity comparisons.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariates.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 48 hours (SPID48). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID48.||59.5|28.6|<0.0001
71152191|NCT00478023|141796301|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|51.4|||<|0.0001||95.0|36.1|66.7||Adjusted. The Hochberg procedure used for multiplicity comparisons.|ANCOVA||Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 48 hours (SPID48). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID48.||66.7|36.1|<0.0001
71152192|NCT00478023|141796301|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|46.9|||<|0.0001||95.0|31.4|62.4||No multiplicity adjustment.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as a covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|Null hypothesis of no treatment difference.||62.4|31.4|<0.0001
71152193|NCT02817464|141796362|OTHER||Geometric Mean Ratio|1.84|||||TWO_SIDED|90.0|1.44|2.36||||||||2.36|1.44|
71152194|NCT02817464|141796363|OTHER||Geometric Mean Ratio|0.66|||||TWO_SIDED|90.0|0.33|1.33||||||||1.33|0.33|
71152195|NCT02817464|141796365|OTHER||Geometric Mean Ratio|1.67|||||TWO_SIDED|90.0|1.33|2.09||||||||2.09|1.33|
71152196|NCT02817464|141796366|OTHER||Geometric Mean Ratio|1.61|||||TWO_SIDED|90.0|1.3|2.01||||||||2.01|1.30|
71152197|NCT02817464|141796367|OTHER||Geometric Mean Ratio|1.21|||||TWO_SIDED|90.0|1.04|1.4||||||||1.40|1.04|
70907032|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.185||0.7297|TWO_SIDED|95.0|-0.3|0.43|||MMRM|||Feelings of Guilt, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.30|0.7297
71029747|NCT06354270|141567491|SUPERIORITY||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.961||0.873|TWO_SIDED|95.0|-2.06|1.75|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||1.75|-2.06|0.8730
71152198|NCT02817464|141796368|OTHER||Geometric Mean Ratio|0.51|||||TWO_SIDED|90.0|0.23|1.13||||||||1.13|0.23|
71152199|NCT02817464|141796370|OTHER|||||||0.0073|||||||Log Rank|||||||0.0073
71152200|NCT02453711|141796381|OTHER||Treatment difference (%-points)|-3.7|STANDARD_ERROR_OF_MEAN|1.13|=|0.0055|TWO_SIDED|95.0|-6.55|-0.85|||ANCOVA||Semaglutide 0.05 mg - placebo pool|J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett's method was used to adjust for multiple comparisons.||-0.85|-6.55|=0.0055
71152201|NCT02453711|141796381|OTHER||Treatment difference (%-points)|-6.32|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|-9.16|-3.49|||ANCOVA||Semaglutide 0.1 mg - placebo pool|J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett's method was used to adjust for multiple comparisons.||-3.49|-9.16|<0.0001
71152202|NCT02453711|141796381|OTHER||Treatment difference (%-points)|-9.31|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|-12.15|-6.46|||ANCOVA||Semaglutide 0.2 mg - placebo pool|J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett's method was used to adjust for multiple comparisons.||-6.46|-12.15|<0.0001
71152203|NCT02453711|141796381|OTHER||Treatment difference (%-points)|-8.88|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|-11.72|-6.03|||ANCOVA||Semaglutide 0.3 mg - placebo pool|J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett's method was used to adjust for multiple comparisons.||-6.03|-11.72|<0.0001
71152204|NCT02453711|141796381|OTHER||Treatment difference (%-points)|-11.55|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|-14.38|-8.72|||ANCOVA||Semaglutide 0.4 mg - placebo pool|J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett's method was used to adjust for multiple comparisons.||-8.72|-14.38|<0.0001
71152205|NCT04292899|141796445|SUPERIORITY||Odds Ratio (OR)|0.75||||0.1563|TWO_SIDED|95.0|0.507|1.115||P-value was calculated using a proportional odds model with treatment as the independent variable and baseline clinical status as a continuous covariate.|Proportional odds model|||||1.115|0.507|0.1563
71152206|NCT04292899|141796445|SUPERIORITY||Odds Ratio (OR)|0.67||||0.0368|TWO_SIDED|95.0|0.458|0.976||P-value was calculated using a proportional odds model with treatment as the independent variable.|Proportional odds model|||||0.976|0.458|0.0368
71152207|NCT04292899|141796446|SUPERIORITY||Difference in Percentages|1.3||||0.7678|TWO_SIDED|95.0|-7.4|10.0||P-value for comparison of the percentages between the two groups was calculated using the Cochran-Mantel-Haenszel test stratified on baseline clinical status.|Cochran-Mantel-Haenszel|||||10.0|-7.4|0.7678
71152208|NCT01600170|141796452|SUPERIORITY|||||||0.39||||||The threshold for statistical significance was p = 0.01|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Primary outcomes were pre-specified to use p\<0.01 for statistical significance. All other analyses used p\<0.05 after adjustment for multiple comparisons.||||0.39
71152209|NCT01600170|141796453|SUPERIORITY||||||<|0.45||||||Threshold of statistical significance was p=0.01|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Primary outcomes were pre-specified to use p\<0.01 for statistical significance. All other analyses used p\<0.05 after adjustment for multiple comparisons.||||<0.45
71152210|NCT01600170|141796454|SUPERIORITY|||||||0.8||||||The threshold for statistical significance was p = 0.01|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Primary outcomes were pre-specified to use p\<0.01 for statistical significance. All other analyses used p\<0.05 after adjustment for multiple comparisons.||||0.80
71152211|NCT01600170|141796455|SUPERIORITY|||||||0.04||||||The threshold of statistical significance was p=0.01|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Primary outcomes were pre-specified to use p\<0.01 for statistical significance. All other analyses used p\<0.05 after adjustment for multiple comparisons.||||0.04
71152212|NCT01600170|141796456|SUPERIORITY|||||||0.15||||||The threshold of statistical significance was p=0.01|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Primary outcomes were pre-specified to use p\<0.01 for statistical significance. All other analyses used p\<0.05 after adjustment for multiple comparisons.||||0.15
71152213|NCT01600170|141796457|SUPERIORITY|||||||0.63||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Secondary outcome analyses used p\<0.05 for statistical significance after adjustment for multiple comparisons.||||0.63
70968629|NCT02819635|141443070|SUPERIORITY||LS Mean Difference|-4.061|||<|0.001|TWO_SIDED|95.0|-5.1252|-2.9974||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|ANCOVA|Stratified by previous biologic use, Baseline corticosteroid use, Baseline Adapted Mayo score (\<= 7 and \> 7)), and Baseline value as covariate.|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||-2.9974|-5.1252|<0.001
71029748|NCT06354270|141567492|SUPERIORITY||Adjusted Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|1.383||0.6191|TWO_SIDED|95.0|-3.43|2.05|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||2.05|-3.43|0.6191
71152214|NCT01600170|141796458|SUPERIORITY|||||||0.035||||||Threshold for statistical significance was p = 0.05|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Secondary outcome analyses used p\<0.05 for statistical significance after adjustment for multiple comparisons.||||0.035
70907033|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.226||0.0626|TWO_SIDED|95.0|-0.87|0.02|||MMRM|||Feelings of Guilt, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.87|0.0626
70907034|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.22||0.5196|TWO_SIDED|95.0|-0.58|0.29|||MMRM|||Feelings of Guilt, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.58|0.5196
70907035|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.234||0.0772|TWO_SIDED|95.0|-0.88|0.05|||MMRM|||Feelings of Guilt, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.88|0.0772
70907036|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.228||0.661|TWO_SIDED|95.0|-0.55|0.35|||MMRM|||Feelings of Guilt, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.55|0.6610
70907037|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.239||0.4007|TWO_SIDED|95.0|-0.67|0.27|||MMRM|||Feelings of Guilt, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.67|0.4007
70907038|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.28|STANDARD_ERROR_OF_MEAN|0.232||0.2292|TWO_SIDED|95.0|-0.18|0.74|||MMRM|||Feelings of Guilt, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.74|-0.18|0.2292
70907039|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.234||0.054|TWO_SIDED|95.0|-0.92|0.01|||MMRM|||Feelings of Guilt, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.92|0.0540
70907040|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.227||0.959|TWO_SIDED|95.0|-0.44|0.46|||MMRM|||Feelings of Guilt, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.44|0.9590
70907041|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.218||0.1048|TWO_SIDED|95.0|-0.79|0.08|||MMRM|||Feelings of Guilt, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.79|0.1048
70907042|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.21||0.8979|TWO_SIDED|95.0|-0.44|0.39|||MMRM|||Feelings of Guilt, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.39|-0.44|0.8979
70968630|NCT02819635|141443071|SUPERIORITY||Adjusted risk difference (%)|6.6||||0.075|TWO_SIDED|95.0|-0.7|13.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||13.9|-0.7|0.075
71029749|NCT06354270|141567492|SUPERIORITY||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.669||0.9521|TWO_SIDED|95.0|-3.41|3.21|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||3.21|-3.41|0.9521
70907043|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.219||0.0819|TWO_SIDED|95.0|-0.82|0.05|||MMRM|||Feelings of Guilt, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.82|0.0819
70907044|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.213||0.1099|TWO_SIDED|95.0|-0.77|0.08|||MMRM|||Feelings of Guilt, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.77|0.1099
70907045|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.215||0.0373|TWO_SIDED|95.0|-0.88|-0.03|||MMRM|||Feelings of Guilt, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.88|0.0373
70907046|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.209||0.0577|TWO_SIDED|95.0|-0.81|0.01|||MMRM|||Feelings of Guilt, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.81|0.0577
70907047|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.21||0.2023|TWO_SIDED|95.0|-0.69|0.15|||MMRM|||Feelings of Guilt, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.69|0.2023
70907048|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.204||0.4444|TWO_SIDED|95.0|-0.56|0.25|||MMRM|||Feelings of Guilt, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.56|0.4444
70907049|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.22||0.3645|TWO_SIDED|95.0|-0.64|0.24|||MMRM|||Feelings of Guilt, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.64|0.3645
70907050|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.214||0.4035|TWO_SIDED|95.0|-0.6|0.24|||MMRM|||Feelings of Guilt, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.60|0.4035
70907051|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.232||0.4877|TWO_SIDED|95.0|-0.62|0.3|||MMRM|||Feelings of Guilt, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.62|0.4877
70907052|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.226||0.3134|TWO_SIDED|95.0|-0.68|0.22|||MMRM|||Feelings of Guilt, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.68|0.3134
70907053|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.24||0.0922|TWO_SIDED|95.0|-0.89|0.07|||MMRM|||Feelings of Guilt, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.89|0.0922
70907054|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.23||0.0761|TWO_SIDED|95.0|-0.87|0.04|||MMRM|||Feelings of Guilt, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.87|0.0761
71090919|NCT03692312|141688157|SUPERIORITY||Mean Difference (Final Values)|4.74|STANDARD_ERROR_OF_MEAN|1.104|<|0.0001|TWO_SIDED|95.0|2.51|6.96|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||6.96|2.51|<0.0001
70907055|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.217||0.3275|TWO_SIDED|95.0|-0.64|0.22|||MMRM|||Feelings of Guilt, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.64|0.3275
70907056|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.213||0.3041|TWO_SIDED|95.0|-0.64|0.2|||MMRM|||Feelings of Guilt, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.64|0.3041
70907057|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.146||0.045|TWO_SIDED|95.0|-0.59|-0.01|||MMRM|||Suicide, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.59|0.0450
70907058|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.143||0.5351|TWO_SIDED|95.0|-0.19|0.37|||MMRM|||Suicide, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.19|0.5351
70907059|NCT02942004|141303703|SUPERIORITY||LS men difference|-0.28|STANDARD_ERROR_OF_MEAN|0.142||0.0525|TWO_SIDED|95.0|-0.56|0.0|||MMRM|||Suicide, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.56|0.0525
70907060|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.139||0.7932|TWO_SIDED|95.0|-0.24|0.31|||MMRM|||Suicide, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.24|0.7932
70907061|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.128||0.13|TWO_SIDED|95.0|-0.45|0.06|||MMRM|||Suicide, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.45|0.1300
70907062|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.125||0.1631|TWO_SIDED|95.0|-0.07|0.42|||MMRM|||Suicide, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.42|-0.07|0.1631
70907063|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.129||0.8215|TWO_SIDED|95.0|-0.23|0.29|||MMRM|||Suicide, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.23|0.8215
70907064|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.126||0.038|TWO_SIDED|95.0|0.01|0.51|||MMRM|||Suicide, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.51|0.01|0.0380
70907065|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.124||0.507|TWO_SIDED|95.0|-0.33|0.16|||MMRM|||Suicide, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.33|0.5070
70907066|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.12||0.1094|TWO_SIDED|95.0|-0.04|0.43|||MMRM|||Suicide, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.04|0.1094
71090920|NCT03692312|141688158|SUPERIORITY||Mean Difference (Final Values)|3.18|STANDARD_ERROR_OF_MEAN|1.099||0.0059|TWO_SIDED|95.0|0.96|5.39|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||5.39|0.96|0.0059
70907067|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.099||0.3112|TWO_SIDED|95.0|-0.3|0.1|||MMRM|||Suicide, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.30|0.3112
70907068|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.096||0.1345|TWO_SIDED|95.0|-0.05|0.33|||MMRM|||Suicide, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.33|-0.05|0.1345
70907069|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.091||0.5148|TWO_SIDED|95.0|-0.24|0.12|||MMRM|||Suicide, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.24|0.5148
70907070|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.088||0.3863|TWO_SIDED|95.0|-0.25|0.1|||MMRM|||Suicide, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.25|0.3863
70907071|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.094||0.0209|TWO_SIDED|95.0|-0.41|-0.03|||MMRM|||Suicide, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.41|0.0209
70907072|NCT02942004|141303703|SUPERIORITY||LS men difference|-0.17|STANDARD_ERROR_OF_MEAN|0.092||0.0616|TWO_SIDED|95.0|-0.35|0.01|||MMRM|||Suicide, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.35|0.0616
70907073|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.099||0.186|TWO_SIDED|95.0|-0.33|0.06|||MMRM|||Suicide, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.33|0.1860
70907074|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.095||0.773|TWO_SIDED|95.0|-0.22|0.16|||MMRM|||Suicide, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.22|0.7730
70907075|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.129||0.1593|TWO_SIDED|95.0|-0.44|0.07|||MMRM|||Suicide, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.44|0.1593
70907076|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.126||0.6371|TWO_SIDED|95.0|-0.31|0.19|||MMRM|||Suicide, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.31|0.6371
70907077|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.124||0.5655|TWO_SIDED|95.0|-0.32|0.18|||MMRM|||Suicide, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.32|0.5655
70968631|NCT02819635|141443071|SUPERIORITY||Adjusted risk difference (%)|3.8||||0.199|TWO_SIDED|95.0|-2.0|9.6||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||9.6|-2.0|0.199
70907078|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.121||0.3326|TWO_SIDED|95.0|-0.12|0.36|||MMRM|||Suicide, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.36|-0.12|0.3326
70907079|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.201||0.3577|TWO_SIDED|95.0|-0.59|0.22|||MMRM|||Suicide, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.59|0.3577
70907080|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.192||0.1646|TWO_SIDED|95.0|-0.66|0.11|||MMRM|||Suicide, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.66|0.1646
70907081|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.118||0.0545|TWO_SIDED|95.0|-0.46|0.0|||MMRM|||Suicide, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.46|0.0545
70907082|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.115||0.2903|TWO_SIDED|95.0|-0.35|0.11|||MMRM|||Suicide, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.35|0.2903
70907083|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.112||0.0395|TWO_SIDED|95.0|0.01|0.45|||MMRM|||Insomnia - Early, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.45|0.01|0.0395
70907084|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.108||0.469|TWO_SIDED|95.0|-0.14|0.29|||MMRM|||Insomnia - Early, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.14|0.4690
70907085|NCT02942004|141303703|SUPERIORITY||LS difference|0.07|STANDARD_ERROR_OF_MEAN|0.139||0.6066|TWO_SIDED|95.0|-0.2|0.35|||MMRM|||Insomnia - Early, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.20|0.6066
70907086|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.136||0.9737|TWO_SIDED|95.0|-0.26|0.27|||MMRM|||Insomnia - Early, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.26|0.9737
70907087|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.148||0.403|TWO_SIDED|95.0|-0.17|0.42|||MMRM|||Insomnia - Early, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.42|-0.17|0.4030
70968632|NCT02819635|141443071|SUPERIORITY||Adjusted risk difference (%)|11.1||||0.015|TWO_SIDED|95.0|2.2|20.0||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||20.0|2.2|0.015
70907088|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.145||0.6357|TWO_SIDED|95.0|-0.36|0.22|||MMRM|||Insomnia - Early, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.36|0.6357
71008701|NCT02055976|141525244|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|16.546|STANDARD_ERROR_OF_MEAN|2.576|<|0.001|TWO_SIDED|95.0|11.43|21.663|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||21.663|11.430|<0.001
70907089|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.134||0.8605|TWO_SIDED|95.0|-0.29|0.24|||MMRM|||Insomnia - Early, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.29|0.8605
70907090|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.13||0.7534|TWO_SIDED|95.0|-0.3|0.22|||MMRM|||Insomnia - Early, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.30|0.7534
70907091|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.201||0.0021|TWO_SIDED|95.0|-1.03|-0.23|||MMRM|||Insomnia - Early, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.23|-1.03|0.0021
70907092|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.196||0.0394|TWO_SIDED|95.0|-0.8|-0.02|||MMRM|||Insomnia - Early, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-0.80|0.0394
70907093|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.208||0.0039|TWO_SIDED|95.0|-1.03|-0.2|||Wilcoxon (Mann-Whitney)|||Insomnia - Early, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.20|-1.03|0.0039
70907094|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.202||0.1591|TWO_SIDED|95.0|-0.69|0.11|||MMRM|||Insomnia - Early, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.69|0.1591
70907095|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.21||0.1402|TWO_SIDED|95.0|-0.73|0.1|||MMRM|||Insomnia - Early, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.73|0.1402
70907096|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.205||0.0143|TWO_SIDED|95.0|-0.91|-0.1|||MMRM|||Insomnia - Early, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.10|-0.91|0.0143
70907097|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.204||0.2293|TWO_SIDED|95.0|-0.65|0.16|||MMRM|||Insomnia - Early, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.65|0.2293
71090921|NCT03692312|141688159|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.108||0.4634|TWO_SIDED|95.0|-0.3|0.14|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||0.14|-0.30|0.4634
70907098|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.2||0.0884|TWO_SIDED|95.0|-0.74|0.05|||MMRM|||Insomnia - Early, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.74|0.0884
70907099|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.207||0.0622|TWO_SIDED|95.0|-0.8|0.02|||MMRM|||Insomnia - Early, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.80|0.0622
71090922|NCT03692312|141688160|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.564||0.5385|TWO_SIDED|95.0|-1.49|0.79|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||0.79|-1.49|0.5385
70907100|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.202||0.0955|TWO_SIDED|95.0|-0.74|0.06|||MMRM|||Insomnia - Early, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.74|0.0955
70907101|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.21||0.0173|TWO_SIDED|95.0|-0.92|-0.09|||MMRM|||Insomnia - Early, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-0.92|0.0173
70907102|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.206||0.1687|TWO_SIDED|95.0|-0.69|0.12|||MMRM|||Insomnia - Early, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.69|0.1687
70907103|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.258||0.3861|TWO_SIDED|95.0|-0.74|0.29|||Wilcoxon (Mann-Whitney)|||Insomnia - Early, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.74|0.3861
70907104|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.249||0.706|TWO_SIDED|95.0|-0.59|0.4|||MMRM|||Insomnia - Early, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.40|-0.59|0.7060
70907105|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.23||0.0112|TWO_SIDED|95.0|-1.05|-0.14|||MMRM|||Insomnia - Early, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.14|-1.05|0.0112
70907106|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.219||0.057|TWO_SIDED|95.0|-0.86|0.01|||MMRM|||Insomnia - Early, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.86|0.0570
70907107|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.208||0.0018|TWO_SIDED|95.0|-1.08|-0.26|||MMRM|||Insomnia - Early, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.26|-1.08|0.0018
70907108|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.205||0.0443|TWO_SIDED|95.0|-0.83|-0.01|||MMRM|||Insomnia - Early, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.83|0.0443
70907109|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.104||0.1197|TWO_SIDED|95.0|-0.04|0.37|||MMRM|||Insomnia - Middle, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.04|0.1197
70907110|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.101||0.7171|TWO_SIDED|95.0|-0.24|0.16|||MMRM|||Insomnia - Middle, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.24|0.7171
71008702|NCT02055976|141525244|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|13.288|STANDARD_ERROR_OF_MEAN|2.593|<|0.001|TWO_SIDED|95.0|8.137|18.438|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||18.438|8.137|<0.001
70907111|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.138||0.7151|TWO_SIDED|95.0|-0.32|0.22|||MMRM|||Insomnia - Middle, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.32|0.7151
70907112|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.134||0.521|TWO_SIDED|95.0|-0.35|0.18|||MMRM|||Insomnia - Middle, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.35|0.5210
70907113|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.142||0.7332|TWO_SIDED|95.0|-0.23|0.33|||MMRM|||Insomnia - Middle, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.33|-0.23|0.7332
70907114|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.139||0.4163|TWO_SIDED|95.0|-0.39|0.16|||MMRM|||Insomnia - Middle, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.39|0.4163
70907115|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.132||0.8625|TWO_SIDED|95.0|-0.28|0.24|||MMRM|||Insomnia - Middle, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.28|0.8625
70907116|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.128||0.6196|TWO_SIDED|95.0|-0.32|0.19|||MMRM|||Insomnia - Middle, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.32|0.6196
70907117|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.197||0.0373|TWO_SIDED|95.0|-0.8|-0.02|||MMRM|||Insomnia - Middle, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-0.80|0.0373
70907118|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.191||0.0644|TWO_SIDED|95.0|-0.74|0.02|||MMRM|||Insomnia - Middle, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.74|0.0644
70907119|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.191||0.1347|TWO_SIDED|95.0|-0.66|0.09|||MMRM|||Insomnia - Middle, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.66|0.1347
70907120|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.185||0.1269|TWO_SIDED|95.0|-0.65|0.08|||MMRM|||Insomnia - Middle, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.65|0.1269
70968633|NCT02819635|141443071|SUPERIORITY||Adjusted risk difference (%)|17.8||||0.004|TWO_SIDED|95.0|5.8|29.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||29.9|5.8|0.004
70968634|NCT02819635|141443072|SUPERIORITY||Adjusted risk difference (%)|25.6||||0.003|TWO_SIDED|95.0|8.9|42.3||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||42.3|8.9|0.003
70907121|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.192||0.165|TWO_SIDED|95.0|-0.65|0.11|||MMRM|||Insomnia - Middle, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.65|0.1650
70907122|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.188||0.1291|TWO_SIDED|95.0|-0.66|0.08|||MMRM|||Insomnia - Middle, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.66|0.1291
70907123|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.189||0.0402|TWO_SIDED|95.0|-0.77|-0.02|||MMRM|||Insomnia - Middle, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-0.77|0.0402
70907124|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.185||0.0342|TWO_SIDED|95.0|-0.76|-0.03|||MMRM|||Insomnia - Middle, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.76|0.0342
70907125|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.193||0.1269|TWO_SIDED|95.0|-0.68|0.09|||MMRM|||Insomnia - Middle, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.68|0.1269
70907126|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.188||0.3945|TWO_SIDED|95.0|-0.53|0.21|||MMRM|||Insomnia - Middle, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.53|0.3945
70907127|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.185||0.5828|TWO_SIDED|95.0|-0.47|0.26|||MMRM|||Insomnia - Middle, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.47|0.5828
70907128|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.182||0.6625|TWO_SIDED|95.0|-0.28|0.44|||MMRM|||Insomnia - Middle, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.44|-0.28|0.6625
70907129|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.216||0.0041|TWO_SIDED|95.0|-1.07|-0.21|||MMRM|||Insomnia - Middle, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.21|-1.07|0.0041
71029750|NCT06354270|141567493|SUPERIORITY||Adjusted Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.795||0.3887|TWO_SIDED|95.0|-0.89|2.26|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||2.26|-0.89|0.3887
71090923|NCT03692312|141688163|SUPERIORITY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.764||0.711|TWO_SIDED|95.0|-1.26|1.83|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||1.83|-1.26|0.7110
71090924|NCT03692312|141688164|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.326||0.7861|TWO_SIDED|95.0|-0.57|0.75|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||0.75|-0.57|0.7861
70907130|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.21||0.2222|TWO_SIDED|95.0|-0.67|0.16|||MMRM|||Insomnia - Middle, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.67|0.2222
71029751|NCT06354270|141567493|SUPERIORITY||Adjusted Mean Difference|0.88|STANDARD_ERROR_OF_MEAN|0.989||0.373|TWO_SIDED|95.0|-1.08|2.84|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||2.84|-1.08|0.3730
70907131|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.218||0.0245|TWO_SIDED|95.0|-0.93|-0.07|||MMRM|||Insomnia - Middle, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.07|-0.93|0.0245
70907132|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.209||0.5119|TWO_SIDED|95.0|-0.55|0.28|||MMRM|||Insomnia - Middle, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.55|0.5119
70907133|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.197||0.0299|TWO_SIDED|95.0|-0.82|-0.04|||MMRM|||Insomnia - Middle, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.04|-0.82|0.0299
70907134|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.195||0.2824|TWO_SIDED|95.0|-0.6|0.18|||MMRM|||Insomnia - Middle, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.60|0.2824
70907135|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.129||0.1768|TWO_SIDED|95.0|-0.08|0.43|||MMRM|||Insomnia - Late, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.08|0.1768
70907136|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.126||0.6498|TWO_SIDED|95.0|-0.31|0.19|||MMRM|||Insomnia - Late, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.31|0.6498
70907137|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.15||0.7689|TWO_SIDED|95.0|-0.25|0.34|||MMRM|||Insomnia - Late, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.34|-0.25|0.7689
70907138|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.146||0.2236|TWO_SIDED|95.0|-0.47|0.11|||MMRM|||Insomnia - Late, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.47|0.2236
71029752|NCT06354270|141567494|SUPERIORITY||Adjusted Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.134||0.1591|TWO_SIDED|95.0|-0.08|0.46|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||0.46|-0.08|0.1591
71029753|NCT06354270|141567494|SUPERIORITY||Adjusted Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.144||0.3429|TWO_SIDED|95.0|-0.15|0.42|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||0.42|-0.15|0.3429
71029754|NCT06354270|141567495|SUPERIORITY||Adjusted Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.411||0.136|TWO_SIDED|95.0|-1.43|0.2|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||0.20|-1.43|0.1360
71029755|NCT06354270|141567495|SUPERIORITY||Adjusted Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.431||0.2914|TWO_SIDED|95.0|-1.31|0.4|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||0.40|-1.31|0.2914
70907139|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.148||0.6952|TWO_SIDED|95.0|-0.35|0.23|||MMRM|||Insomnia - Late, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.35|0.6952
71029756|NCT01939197|141567496|NON_INFERIORITY|The primary efficacy endpoint was the non-inferiority of the percentage of participants in the GT1 Analysis Group in Part 2 achieving SVR12 compared to the historical SVR12 rate for sofosbuvir plus ribavirin (a non-inferiority threshold of the lower bound of the 95% CI of 74%).|||||||||||||||||"The historical SVR rate, as reported in the PHOTON-1 study, for sofosbuvir and RBV in HCV/HIV-1 coinfected adults is 76% (87/114) with a 95% confidence interval of (67%, 84%).~Reference: Sulkowski MS, Naggie S, Lalezari J, et al. Sofosbuvir and ribavirin for hepatitis C in patients with HIV coinfection. JAMA. 2014;312(4):353-61."|||
70907140|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.144||0.1184|TWO_SIDED|95.0|-0.51|0.06|||MMRM|||Insomnia - Late, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.51|0.1184
70907141|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.149||0.3031|TWO_SIDED|95.0|-0.14|0.45|||MMRM|||Insomnia - Late, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.45|-0.14|0.3031
70907142|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.145||0.3091|TWO_SIDED|95.0|-0.44|0.14|||MMRM|||Insomnia - Late, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.44|0.3091
70907143|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.179||0.1525|TWO_SIDED|95.0|-0.61|0.1|||MMRM|||Insomnia - Late, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.61|0.1525
70907144|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.174||0.1214|TWO_SIDED|95.0|-0.62|0.07|||MMRM|||Insomnia - Late, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.62|0.1214
70907145|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.187||0.3811|TWO_SIDED|95.0|-0.53|0.21|||MMRM|||Insomnia - Late, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.53|0.3811
70907146|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.18||0.3851|TWO_SIDED|95.0|-0.51|0.2|||MMRM|||Insomnia - Late, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.51|0.3851
70907147|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.182||0.1373|TWO_SIDED|95.0|-0.63|0.09|||MMRM|||Insomnia - Late, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.63|0.1373
70907148|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.177||0.136|TWO_SIDED|95.0|-0.62|0.09|||MMRM|||Insomnia - Late, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.62|0.1360
71090925|NCT03692312|141688165|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.123||0.6282|TWO_SIDED|95.0|-0.19|0.31|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. A compound symmetry variance-covariance matrix has been used.||0.31|-0.19|0.6282
70907149|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.176||0.1264|TWO_SIDED|95.0|-0.62|0.08|||MMRM|||Insomnia - Late, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.62|0.1264
71029757|NCT01939197|141567497|OTHER|||||||1|||||||Fisher Exact|||||||1.000
71090926|NCT03692312|141688166|SUPERIORITY|||||||0.0428|||||||t-test, 2 sided|||||||0.0428
70907150|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.172||0.0567|TWO_SIDED|95.0|-0.67|0.01|||MMRM|||Insomnia - Late, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.67|0.0567
71029758|NCT01939197|141567498|OTHER||||||||||||||||||"The Fisher exact test was performed as prespecified on the SAP but the p-value couldn't be calculated because SVR12 rates in both arms were 100%, hence p-value appeared as not available."|||
70907151|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.176||0.7447|TWO_SIDED|95.0|-0.41|0.29|||MMRM|||Insomnia - Late, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.41|0.7447
70907152|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.172||0.7727|TWO_SIDED|95.0|-0.39|0.29|||MMRM|||Insomnia - Late, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.39|0.7727
70907153|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.183||0.659|TWO_SIDED|95.0|-0.28|0.44|||MMRM|||Insomnia - Late, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.44|-0.28|0.6590
70907154|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.18||0.3951|TWO_SIDED|95.0|-0.51|0.2|||MMRM|||Insomnia - Late, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.51|0.3951
70907155|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.23||0.4576|TWO_SIDED|95.0|-0.63|0.28|||MMRM|||Insomnia - Late, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.63|0.4576
70907156|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.223||0.7609|TWO_SIDED|95.0|-0.51|0.37|||MMRM|||Insomnia - Late, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.51|0.7609
70907157|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.234||0.622|TWO_SIDED|95.0|-0.58|0.35|||MMRM|||Insomnia - Late, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.58|0.6220
70907158|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.225||0.9081|TWO_SIDED|95.0|-0.42|0.47|||MMRM|||Insomnia - Late, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.47|-0.42|0.9081
70907159|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.191||0.1668|TWO_SIDED|95.0|-0.65|0.11|||MMRM|||Insomnia - Late, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.65|0.1668
70907160|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.189||0.0935|TWO_SIDED|95.0|-0.69|0.05|||MMRM|||Insomnia - Late, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.69|0.0935
71090927|NCT03692312|141688167|SUPERIORITY||Ratio|0.77|STANDARD_ERROR_OF_MEAN|0.094||0.0379|TWO_SIDED|95.0|0.6|0.98|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||0.98|0.60|0.0379
70907161|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.15||0.4038|TWO_SIDED|95.0|-0.42|0.17|||MMRM|||Work and Activities, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.42|0.4038
71029759|NCT02781727|141567551|NON_INFERIORITY|Non-inferiority comparison with a non-inferiority margin of 2 cm/year, followed by a test of superiority if non-inferiority is established.||||||0.0088||||||P-value is based on a test of superiority|ANCOVA with multiple imputation|two-sided||ANCOVA model with multiple imputation. For each imputed data set, an ANCOVA model with by visit AHV as the dependent variable; treatment and gender as factors; and baseline age, baseline peak GH levels (log transformed) at stimulation test, and baseline height SDS - average parental height SDS as covariates were fitted.||||0.0088
70907162|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.145||0.7559|TWO_SIDED|95.0|-0.24|0.33|||MMRM|||Work and Activities, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.33|-0.24|0.7559
70907163|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.181||0.2006|TWO_SIDED|95.0|-0.59|0.13|||MMRM|||Work and Activities, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.59|0.2006
70907164|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.175||0.6334|TWO_SIDED|95.0|-0.26|0.43|||MMRM|||Work and Activities, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.26|0.6334
70907165|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.23||0.5431|TWO_SIDED|95.0|-0.6|0.32|||MMRM|||Work and Activities, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.60|0.5431
70907166|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.225||0.5278|TWO_SIDED|95.0|-0.3|0.59|||MMRM|||Work and Activities, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.59|-0.30|0.5278
70907167|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.232||0.4312|TWO_SIDED|95.0|-0.64|0.28|||MMRM|||Work and Activities, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.64|0.4312
70907168|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.225||0.3947|TWO_SIDED|95.0|-0.25|0.64|||MMRM|||Work and Activities, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.64|-0.25|0.3947
70907169|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.244||0.6081|TWO_SIDED|95.0|-0.61|0.36|||MMRM|||Work and Activities, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.36|-0.61|0.6081
70907170|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.238||0.8949|TWO_SIDED|95.0|-0.44|0.5|||MMRM|||Work and Activities, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.50|-0.44|0.8949
70907171|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.236||0.112|TWO_SIDED|95.0|-0.84|0.09|||MMRM|||Work and Activities, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.84|0.1120
70907172|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.228||0.1842|TWO_SIDED|95.0|-0.15|0.76|||MMRM|||Work and Activities, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.76|-0.15|0.1842
70925900|NCT04788511|141345651|SUPERIORITY||Estimated Treatment Difference|7.8|||<|0.0001|TWO_SIDED|95.0|4.8|10.9|||ANCOVA|||The responses at week 52 were analyzed using an analysis of covariance model with randomized treatment and stratification (BMI\<35.0 kg/m\^2, BMI\>=35.0 kg/m\^2) as factors and baseline KCCQ-CSS as covariate. The analysis was based on the in-trial period using the FAS population. Missing observations at week 52 were multiple (x1000) imputed from retrieved participants of the same randomized treatment arm.||10.9|4.8|<0.0001
71090928|NCT03692312|141688169|SUPERIORITY|||||||0.078|||||||t-test, 2 sided|||Cmax upper quantiles group compared to the placebo group for mean change from baseline; two-tailed t-test assuming unequal variance.||||0.078
71090929|NCT03692312|141688171|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||Cmax upper quantiles group compared to the placebo group for mean change from baseline; two-tailed t-test assuming unequal variance.||||0.29
70907173|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.26||0.2646|TWO_SIDED|95.0|-0.81|0.22|||MMRM|||Work and Activities, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.81|0.2646
70907174|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.253||0.8101|TWO_SIDED|95.0|-0.56|0.44|||MMRM|||Work and Activities, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.44|-0.56|0.8101
70907175|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.248||0.0215|TWO_SIDED|95.0|-1.07|-0.09|||MMRM|||Work and Activities, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-1.07|0.0215
70907176|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.242||0.3226|TWO_SIDED|95.0|-0.72|0.24|||MMRM|||Work and Activities, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.72|0.3226
70907177|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.238||0.0339|TWO_SIDED|95.0|-0.98|-0.04|||MMRM|||Work and Activities, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.04|-0.98|0.0339
70907178|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.232||0.9824|TWO_SIDED|95.0|-0.46|0.47|||MMRM|||Work and Activities, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.47|-0.46|0.9824
70907179|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.254||0.095|TWO_SIDED|95.0|-0.93|0.08|||MMRM|||Work and Activities, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.93|0.0950
70907180|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.249||0.4865|TWO_SIDED|95.0|-0.67|0.32|||MMRM|||Work and Activities, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.67|0.4865
70907181|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.292||0.9861|TWO_SIDED|95.0|-0.57|0.58|||MMRM|||Work and Activities, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.58|-0.57|0.9861
71029760|NCT00406848|141567560|SUPERIORITY_OR_OTHER|||||||0.397||95.0||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||Tested was the null hypothesis that there would be no difference in changes from baseline (Week 1) to Week 13 on the HAMD-17 Maier subscale between duloxetine and placebo treatment groups.||||0.397
71029761|NCT00406848|141567561|SUPERIORITY_OR_OTHER|||||||0.115||95.0||||p-value is for difference between duloxetine and placebo on change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.115
71152215|NCT01600170|141796459|SUPERIORITY|||||||0.62||||||The threshold of statistical significance was p = 0.05|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Secondary outcome analyses used p\<0.05 for statistical significance after adjustment for multiple comparisons.||||0.62
71152216|NCT01600170|141796460|SUPERIORITY|||||||0.99||||||The threshold of statistical significance was p = 0.05|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Secondary outcome analyses used p\<0.05 for statistical significance after adjustment for multiple comparisons.||||0.99
71152217|NCT01209325|141796463|SUPERIORITY|||||||0.112||||||Two-sided p-value|Exact poisson test|||||||0.112
71152218|NCT01209325|141796463|SUPERIORITY|||||||0.447||||||One-sided test|Exact Poisson calculation|||This study's Naive to HPV 6 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 6 (NCT00090285), 0.0 events per 100 person years (PY) versus 3.4 events per 100 PY, respectively.||||0.447
71152219|NCT01209325|141796464|SUPERIORITY|||||||0.224||||||Two-sided p-value.|Exact poisson test|||||||0.224
71152220|NCT01209325|141796464|SUPERIORITY|One-sided p-value.||||||0.361|||||||Exact Poisson calculation|||This study's Naive to HPV 11 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 11 (NCT00090285), 0.0 events per 100 person years (PY) versus 2.0 events per 100 PY, respectively.||||0.361
71152221|NCT01209325|141796465|SUPERIORITY|||||||0.079||||||Two-sided p-value.|Exact poisson test|||||||0.079
71152222|NCT01209325|141796465|SUPERIORITY|||||||0.35||||||One-sided p-value.|Exact Poisson calculation|||This study's Naive to HPV 16 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 16 (NCT00090285), 0.0 events per 100 person years (PY) versus 1.8 events per 100 PY, respectively.||||0.350
71152223|NCT01209325|141796466|SUPERIORITY|||||||0.162|||||||Exact poisson test|||||||0.162
71152224|NCT01209325|141796466|SUPERIORITY|||||||0.49||||||One-sided p-value|Exact Poisson calculation|||This study's Naive to HPV 18 group was compared to the Merck 020 per-protocol historical placebo group naive to HPV 18 (NCT00090285), 0.0 events per 100 person years (PY) versus 1.0 events per 100 PY, respectively.||||0.490
71152225|NCT01209325|141796467|SUPERIORITY|||||||0.671||||||Two-sided p-value is comparing naive and prior exposure groups for HPV 6.|Exact Poisson calculation|||||||0.671
71152226|NCT01209325|141796467|SUPERIORITY|||||||0.312||||||One-sided p-value.|Exact Poisson calculation|||This study's Naive to HPV 6 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 6 (NCT00090285), 1.8 events per 100 person years (PY) versus 4.5 events per 100 PY, respectively.||||0.312
70968635|NCT02819635|141443072|SUPERIORITY||Adjusted risk difference (%)|43.6|||<|0.001|TWO_SIDED|95.0|25.4|61.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||61.8|25.4|<0.001
71152227|NCT01209325|141796468|SUPERIORITY||||||>|0.999||||||Two-sided p-value.|Exact Poisson calculation|||||||>0.999
71029762|NCT00406848|141567561|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||p-value is for difference between duloxetine and placebo on change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.004
71152228|NCT01209325|141796468|SUPERIORITY|||||||0.209||||||One-sided p-value.|Exact Poisson calculation|||This study's Naive to HPV 11 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 11 (NCT00090285), 0.0 events per 100 person years (PY) versus 1.7 events per 100 PY, respectively.||||0.209
71152229|NCT01209325|141796469|SUPERIORITY|||||||0.386||||||Two-sided p-value.|Exact Poisson calculation|||||||0.386
71152230|NCT01209325|141796469|SUPERIORITY|||||||0.305||||||One-sided test|Exact Poisson calculation|||This study's Naive to HPV 16 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 16 (NCT00090285), 2.9 events per 100 person years (PY) versus 4.9 events per 100 PY, respectively.||||0.305
71152231|NCT01209325|141796470|SUPERIORITY|||||||0.622||||||Two-sided p-value.|Exact Poisson calculation|||||||0.622
71152232|NCT01209325|141796470|SUPERIORITY|||||||0.15||||||One-sided p-value.|Exact Poisson calculation|||This study's Naive to HPV 18 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 18 (NCT00090285), 0.7 events per 100 person years (PY) versus 2.7 events per 100 PY, respectively.||||0.150
71152233|NCT01209325|141796471|SUPERIORITY|||||||0.064||||||Two-sided p-value.|Exact Poisson calculation|||||||0.064
71152234|NCT01209325|141796472|SUPERIORITY|||||||0.745||||||Two-sided test.|Exact Poisson calculation|||||||0.745
71152235|NCT01209325|141796473|SUPERIORITY|||||||0.014|||||||Exact Poisson calculation|||||||0.014
71152236|NCT01209325|141796474|SUPERIORITY|||||||0.166||||||Two-sided p-value.|Exact Poisson calculation|||||||0.166
71152237|NCT01209325|141796475|SUPERIORITY|||||||0.789||||||Two-sided p-value.|Exact Poisson calculation|||||||0.789
71152238|NCT01209325|141796476|SUPERIORITY|||||||0.809||||||Two-sided p-value.|0.809|||||||0.809
71152239|NCT01209325|141796477|SUPERIORITY|||||||0.422||||||Two-sided p-value.|Exact Poisson calculation|||||||0.422
71152240|NCT01209325|141796478|SUPERIORITY|||||||0.423||||||Two-sided p-value.|Exact Poisson calculation|||||||0.423
71152241|NCT05340478|141796503|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
71152242|NCT00092443|141796510|SUPERIORITY_OR_OTHER||Efficacy = 1-Relative Risk|72.5|||<|0.001||95.0|50.6|85.6|||Exact Binomial Test||Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group.|||85.6|50.6|<0.001
71152243|NCT00092443|141796511|SUPERIORITY_OR_OTHER||Percent of Participants|56.7||||||95.0|44.0|66.8||||||||66.8|44.0|
71152244|NCT00092443|141796511|SUPERIORITY_OR_OTHER||Percent of Participants|2.7||||||95.0|0.3|9.5||||||||9.5|0.3|
71152245|NCT00092443|141796511|SUPERIORITY_OR_OTHER||Percent of Participants|14.5||||||95.0|6.9|25.8||||||||25.8|6.9|
71152246|NCT00092443|141796511|SUPERIORITY_OR_OTHER||Percent of Participants|0.0||||||95.0|0.0|5.1||||||||5.1|0.0|
71152247|NCT00092443|141796511|SUPERIORITY_OR_OTHER||Percent of Participants|9.0||||||95.0|3.4|18.5||||||||18.5|3.4|
71152248|NCT00092443|141796511|SUPERIORITY_OR_OTHER||Percent of Participants|0.0||||||95.0|0.0|4.8||||||||4.8|0.0|
71152249|NCT00092443|141796511|SUPERIORITY_OR_OTHER||Percent of Participants|39.7||||||95.0|27.6|52.8||||||||52.8|27.6|
71152250|NCT00092443|141796511|SUPERIORITY_OR_OTHER||Percent of Participants|1.4||||||95.0|0.0|7.7||||||||7.7|0.0|
71152251|NCT00092443|141796511|SUPERIORITY_OR_OTHER||Percent of Participants|24.6||||||95.0|14.5|37.3||||||||37.3|14.5|
71152252|NCT00092443|141796511|SUPERIORITY_OR_OTHER||Percent of Participants|2.9||||||95.0|0.4|10.1||||||||10.1|0.4|
71152253|NCT02605122|141796529|OTHER||Proportion experiencing TEAE or TESAE|34.3|||||TWO_SIDED|95.0|23.0|47.0||No p-value was performed. Study prematurely discontinued. Clopper-Pearson analysis was used to determine confidence intervals.|Clopper-Pearson|||||47|23|
71152254|NCT02605122|141796530|OTHER||Achievement of ECR|62.1|||||TWO_SIDED|95.0|49.0|74.0||No p-value was performed. Study prematurely discontinued. Clopper-Pearson analysis was used to determine confidence intervals.|Clopper-Pearson|||||74|49|
71152255|NCT02605122|141796531|OTHER||Achievement of Clinical Improvement|68.7|||||TWO_SIDED|95.0|58.0|78.0||No p-value was performed. Study prematurely discontinued. Clopper-Pearson analysis was used to determine confidence intervals.|Clopper-Pearson|||||78|58|
71152256|NCT02605122|141796532|OTHER||Achievement of Clinical Cure|62.0|||||TWO_SIDED|95.0|50.0|73.0||No p-value was performed. Study prematurely discontinued. Clopper-Pearson was used to determine confidence intervals.|Clopper-Pearson|||||73|50|
71152257|NCT03284307|141796545|SUPERIORITY||Slope|0.11|STANDARD_ERROR_OF_MEAN|0.043||0.012|TWO_SIDED|||||Statistical significance defined by p \< 0.05.|Mixed Models Analysis||Estimate is a slope from a linear mixed effects model representing the difference in occipital delta power between unconsciousness and disconnected consciousness after adjusting for within-subject effects.|Dexmedetomidine, Unconsciousness vs Disconnected Consciousness||||0.012
71152258|NCT03284307|141796545|SUPERIORITY||Slope|-0.238|STANDARD_ERROR_OF_MEAN|0.199||0.236|TWO_SIDED|||||Statistical significance defined by p \< 0.05.|Mixed Models Analysis||Estimate is a slope from a linear mixed effects model representing the difference in occipital delta power between unconsciousness and disconnected consciousness after adjusting for within-subject effects.|Ketamine, Unconsciousness vs Disconnected Consciousness||||0.236
71152259|NCT03284307|141796545|SUPERIORITY||Slope|0.166|STANDARD_ERROR_OF_MEAN|0.12||0.174|TWO_SIDED|||||Statistical significance defined by p \< 0.05.|Mixed Models Analysis||Estimate is a slope from a linear mixed effects model representing the difference in occipital delta power between unconsciousness and disconnected consciousness after adjusting for within-subject effects.|Propofol, Unconsciousness vs Disconnected Consciousness||||0.174
71152260|NCT03284307|141796545|SUPERIORITY||Slope|0.052|STANDARD_ERROR_OF_MEAN|0.111||0.64|TWO_SIDED|||||Statistical significance defined by p \< 0.05.|Mixed Models Analysis||Estimate is a slope from a linear mixed effects model representing the difference in occipital delta power between unconsciousness and disconnected consciousness after adjusting for within-subject effects.|Sleep, Unconsciousness vs Disconnected Consciousness||||0.640
71152261|NCT03284307|141796547|SUPERIORITY|||||||0.134||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|3 degrees of freedom||NIH Toolbox Card Sorting Score||||0.134
71152262|NCT03284307|141796547|SUPERIORITY|||||||0.012||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|6 degrees of freedom||NIH Toolbox Card Sorting Score||||0.012
71152263|NCT03284307|141796547|SUPERIORITY|||||||0.487||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|1 degree of freedom||NIH Toolbox Card Sorting Score||||0.487
71029763|NCT00406848|141567562|SUPERIORITY_OR_OTHER|||||||0.773||95.0||||p-value is for HAMD-17 total score change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.773
71152264|NCT03284307|141796547|SUPERIORITY|||||||0.046||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|3 degrees of freedom||NIH Toolbox Flanker Score||||0.046
71152265|NCT03284307|141796547|SUPERIORITY|||||||0.01||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|6 degrees of freedom||NIH Toolbox Flanker Score||||0.010
71152266|NCT03284307|141796547|SUPERIORITY|||||||0.356||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|||NIH Toolbox Flanker Score||||0.356
71152267|NCT03284307|141796548|SUPERIORITY||||||<|0.001||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|17 degrees of freedom||Predictive Coding Task Accuracy||||<0.001
71152268|NCT03284307|141796548|SUPERIORITY||||||<|0.001||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|14 degrees of freedom||Predictive Coding Task Accuracy||||<0.001
71152269|NCT03284307|141796548|SUPERIORITY|||||||0.067||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|4 degrees of freedom||Predictive Coding Task Accuracy||||0.067
71152270|NCT03284307|141796549|SUPERIORITY|||||||0.5||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|17 degrees of freedom||Null hypothesis is a 50% recall rate.||||0.5
71152271|NCT03284307|141796549|SUPERIORITY|||||||0.37||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|11 degrees of freedom||Null hypothesis is a 50% recall rate.||||0.37
71152272|NCT03284307|141796549|SUPERIORITY|||||||0.12||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|4 degrees of freedom||Null hypothesis is a 50% recall rate.||||0.12
71152273|NCT03249116|141796608|SUPERIORITY||F statistic|0.33||||0.723|TWO_SIDED|||||The threshold for statistical significance was p\<.05|ANOVA|dependent variable: self-reported anxiety between-subjects factors: condition, social anxiety within-subjects factor: time||||||.723
71152274|NCT03249116|141796609|SUPERIORITY||F statistic|1.34||||0.271|TWO_SIDED|||||The threshold for statistical significance was p\<.05|ANOVA|dependent variable: electrodermal activity between-subjects factors: condition, social anxiety within-subjects factor: time||||||.271
71152275|NCT03249116|141796610|SUPERIORITY||F statistic|0.45||||0.638|TWO_SIDED|||||The threshold for statistical significance was p\<.05|ANOVA|dependent variable: heart rate between-subjects factors: condition, social anxiety within-subjects factor: time||||||.638
71152276|NCT03249116|141796611|SUPERIORITY||F statistic|0.14||||0.868|TWO_SIDED|||||The threshold for statistical significance was p\<.05|ANOVA|dependent variable: number of errors between-subjects factors: condition, social anxiety||||||.868
71152277|NCT03249116|141796612|SUPERIORITY||F statistic|0.21||||0.809|TWO_SIDED|||||The threshold for statistical significance was p\<.05|ANOVA|dependent variable: lowest number reached/highest number of correct responses between-subjects factors: condition, social anxiety||||||.809
71152278|NCT00221117|141796613|OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||||||.015
71152279|NCT00221117|141796614|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||The subject's impairment and demographic characteristics were analyzed using descriptive statistics for parametric and nonparametric data. The baseline outcome data of the intervention and control groups were compared using Fisher exact test (for categorical variables) and Mann-Whitney U test (for continuous variables). Comparisons between the intervention and control groups were carried out using linear regression analysis adjusted for the baseline degree of disability (baseline AIS).||||0.05
70907182|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.283||0.9266|TWO_SIDED|95.0|-0.59|0.54|||MMRM|||Work and Activities, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.54|-0.59|0.9266
70907183|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.285||0.036|TWO_SIDED|95.0|-1.17|-0.04|||MMRM|||Work and Activities, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.04|-1.17|0.0360
71090930|NCT03692312|141688173|SUPERIORITY|||||||0.077|||||||t-test, 2 sided|||Cmax upper quantiles group compared to the placebo group for mean change from baseline (absolute value); two-tailed t-test assuming unequal variance.||||0.077
71090931|NCT03692312|141688174|SUPERIORITY|||||||0.071|||||||t-test, 2 sided|||Cmax upper quantiles group compared to placebo group for mean Raw Score; two-tailed t-test assuming unequal variance.||||0.071
70907184|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.273||0.0583|TWO_SIDED|95.0|-1.06|0.02|||MMRM|||Work and Activities, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-1.06|0.0583
70907185|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.254||0.0404|TWO_SIDED|95.0|-1.03|-0.02|||MMRM|||Work and Activities, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-1.03|0.0404
70907186|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.249||0.1352|TWO_SIDED|95.0|-0.87|0.12|||MMRM|||Work and Activities, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.87|0.1352
70907187|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.121||0.0056|TWO_SIDED|95.0|0.1|0.58|||MMRM|||Retardation, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.58|0.10|0.0056
70907188|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.118||0.1537|TWO_SIDED|95.0|-0.06|0.4|||MMRM|||Retardation, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.40|-0.06|0.1537
70907189|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.32|STANDARD_ERROR_OF_MEAN|0.129||0.0142|TWO_SIDED|95.0|0.07|0.58|||MMRM|||Retardation, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.58|0.07|0.0142
71090932|NCT02592824|141688182|SUPERIORITY|||||||0.086|||||||t-test, 2 sided|||Two-sided Student's t-test used for sample size estimation which was based on data from the first GLUTAMICS trial.||||0.086
71090933|NCT02592824|141688183|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
71090934|NCT02592824|141688184|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
71090935|NCT02592824|141688189|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||0.007
71090936|NCT05033041|141688218|EQUIVALENCE|Equivalence is based on an equivalence hypothesis of -17mL \<difference in differences \< 17mL.||||||0.001|||||||t-test, 1 sided|||Comparison of the means using two one-sided t tests (TOST)||||.001
71102622|NCT04875533|141713840|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.91|||||TWO_SIDED|95.0|0.77|1.08||||||Serotype 6B: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||1.08|0.77|
71029764|NCT00406848|141567562|SUPERIORITY_OR_OTHER|||||||0.084||95.0||||p-value is for HAMD-17 total score change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.084
70907190|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.31|STANDARD_ERROR_OF_MEAN|0.126||0.0159|TWO_SIDED|95.0|0.06|0.56|||MMRM|||Retardation, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.56|0.06|0.0159
70907191|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.132||0.2255|TWO_SIDED|95.0|-0.1|0.42|||MMRM|||Retardation, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.42|-0.10|0.2255
70907192|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.129||0.1069|TWO_SIDED|95.0|-0.05|0.46|||MMRM|||Retardation, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.05|0.1069
70907193|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.144||0.4932|TWO_SIDED|95.0|-0.19|0.39|||MMRM|||Retardation, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.39|-0.19|0.4932
70907194|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.14||0.2634|TWO_SIDED|95.0|-0.12|0.43|||MMRM|||Retardation, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.12|0.2634
70907195|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.133||0.9284|TWO_SIDED|95.0|-0.25|0.28|||MMRM|||Retardation, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.25|0.9284
70907196|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.129||0.9459|TWO_SIDED|95.0|-0.25|0.26|||MMRM|||Retardation, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.25|0.9459
70907197|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.151||0.2908|TWO_SIDED|95.0|-0.46|0.14|||MMRM|||Retardation, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.46|0.2908
70907198|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.146||0.6834|TWO_SIDED|95.0|-0.23|0.35|||MMRM|||Retardation, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.23|0.6834
70907199|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.142||0.3579|TWO_SIDED|95.0|-0.41|0.15|||MMRM|||Retardation, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.41|0.3579
70907200|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.138||0.827|TWO_SIDED|95.0|-0.3|0.24|||MMRM|||Retardation, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.30|0.8270
71029765|NCT00406848|141567562|SUPERIORITY_OR_OTHER|||||||0.059||95.0||||p-value is for Maier subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.059
71102623|NCT04875533|141713840|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.84|||||TWO_SIDED|95.0|0.75|0.93||||||Serotype 7F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.93|0.75|
70907201|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.13||0.5292|TWO_SIDED|95.0|-0.34|0.18|||MMRM|||Retardation, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.34|0.5292
70907202|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.127||0.879|TWO_SIDED|95.0|-0.23|0.27|||MMRM|||Retardation, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.23|0.8790
70907203|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.133||0.1347|TWO_SIDED|95.0|-0.46|0.06|||MMRM|||Retardation, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.46|0.1347
70907204|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.129||0.2874|TWO_SIDED|95.0|-0.4|0.12|||MMRM|||Retardation, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.40|0.2874
70907205|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.132||0.0086|TWO_SIDED|95.0|-0.61|-0.09|||MMRM|||Retardation, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-0.61|0.0086
70907206|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.129||0.7864|TWO_SIDED|95.0|-0.29|0.22|||MMRM|||Retardation, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.29|0.7864
70907207|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.172||0.4383|TWO_SIDED|95.0|-0.48|0.21|||MMRM|||Retardation, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.48|0.4383
70907208|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.167||0.8767|TWO_SIDED|95.0|-0.36|0.31|||MMRM|||Retardation, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.36|0.8767
71029766|NCT00406848|141567562|SUPERIORITY_OR_OTHER|||||||0.488||95.0||||p-value is for Bech subscale change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.488
70907209|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.153||0.0341|TWO_SIDED|95.0|-0.63|-0.03|||MMRM|||Retardation, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.63|0.0341
70968636|NCT02819635|141443072|SUPERIORITY||Adjusted risk difference (%)|39.4|||<|0.001|TWO_SIDED|95.0|21.3|57.5||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||57.5|21.3|<0.001
70968637|NCT02819635|141443072|SUPERIORITY||Adjusted risk difference (%)|43.1|||<|0.001|TWO_SIDED|95.0|24.4|61.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||61.9|24.4|<0.001
70907210|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.147||0.5629|TWO_SIDED|95.0|-0.38|0.21|||MMRM|||Retardation, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.38|0.5629
70907211|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.129||0.0016|TWO_SIDED|95.0|-0.67|-0.16|||MMRM|||Retardation, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.16|-0.67|0.0016
70907212|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.126||0.0495|TWO_SIDED|95.0|-0.5|0.0|||MMRM|||Retardation, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.50|0.0495
70907213|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.155||0.7177|TWO_SIDED|95.0|-0.36|0.25|||MMRM|||Agitation, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.36|0.7177
70907214|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.151||0.9401|TWO_SIDED|95.0|-0.29|0.31|||MMRM|||Agitation, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.29|0.9401
70907215|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.147||0.3201|TWO_SIDED|95.0|-0.44|0.15|||MMRM|||Agitation, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.44|0.3201
70907216|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.144||0.8286|TWO_SIDED|95.0|-0.25|0.32|||MMRM|||Agitation, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.25|0.8286
70907217|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.162||0.3022|TWO_SIDED|95.0|-0.49|0.15|||MMRM|||Agitation, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.49|0.3022
70968638|NCT02819635|141443073|SUPERIORITY||Adjusted risk difference (%)|29.3|||<|0.001|TWO_SIDED|95.0|22.6|35.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||35.9|22.6|<0.001
70968639|NCT02819635|141443074|SUPERIORITY||Adjusted risk difference (%)|12.7|||<|0.001|TWO_SIDED|95.0|8.4|17.0||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||17.0|8.4|<0.001
70907218|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.158||0.8022|TWO_SIDED|95.0|-0.35|0.27|||MMRM|||Agitation, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.35|0.8022
70907219|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.165||0.5665|TWO_SIDED|95.0|-0.42|0.23|||MMRM|||Agitation, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.42|0.5665
71029767|NCT00406848|141567562|SUPERIORITY_OR_OTHER|||||||0.048||95.0||||p-value is for HAMD-17 Bech subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.048
70907220|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.161||0.817|TWO_SIDED|95.0|-0.36|0.28|||MMRM|||Agitation, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.36|0.8170
70907221|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.155||0.0404|TWO_SIDED|95.0|-0.63|-0.01|||MMRM|||Agitation, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.63|0.0404
70907222|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.151||0.3128|TWO_SIDED|95.0|-0.45|0.15|||MMRM|||Agitation, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.45|0.3128
70907223|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.162||0.24|TWO_SIDED|95.0|-0.51|0.13|||MMRM|||Agitation, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.51|0.2400
70907224|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.157||0.484|TWO_SIDED|95.0|-0.42|0.2|||MMRM|||Agitation, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.42|0.4840
70907225|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.141||0.7768|TWO_SIDED|95.0|-0.32|0.24|||MMRM|||Agitation, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.32|0.7768
70907226|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.137||0.7713|TWO_SIDED|95.0|-0.31|0.23|||MMRM|||Agitation, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.31|0.7713
70907227|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.151||0.0716|TWO_SIDED|95.0|-0.58|0.02|||MMRM|||Agitation, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.58|0.0716
70968640|NCT02819635|141443075|SUPERIORITY||Adjusted risk difference (%)|46.3|||<|0.001|TWO_SIDED|95.0|38.4|54.2||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||54.2|38.4|<0.001
70968641|NCT02819635|141443076|SUPERIORITY||Adjusted risk difference (%)|33.3|||<|0.001|TWO_SIDED|95.0|24.8|41.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)||Substudy 2: Upadacitinib 45 mg vs Placebo|Difference = Upadacitinib 45 mg - Placebo|41.8|24.8|<0.001
70907228|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.148||0.4317|TWO_SIDED|95.0|-0.41|0.18|||MMRM|||Agitation, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.41|0.4317
70925901|NCT04788511|141345652|SUPERIORITY||Estimated Treatment Difference|-10.7|||<|0.0001|TWO_SIDED|95.0|-11.9|-9.4|||ANCOVA|||The responses were analyzed using an analysis of covariance model with randomized treatment and stratification (BMI\<35.0 kg/m\^2, BMI\>=35.0 kg/m\^2) as factors and baseline body weight (kg) as covariate. The analysis was based on the in-trial period using the FAS population. Missing observations at week 52 were multiple (x1000) imputed from retrieved participants of the same randomized treatment arm.||-9.4|-11.9|<0.0001
70907229|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.162||0.2115|TWO_SIDED|95.0|-0.52|0.12|||MMRM|||Agitation, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.52|0.2115
70907230|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.158||0.2818|TWO_SIDED|95.0|-0.48|0.14|||MMRM|||Agitation, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.48|0.2818
70907231|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.14||0.2018|TWO_SIDED|95.0|-0.46|0.1|||MMRM|||Agitation, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.46|0.2018
70907232|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.137||0.6554|TWO_SIDED|95.0|-0.33|0.21|||MMRM|||Agitation, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.33|0.6554
70907233|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.168||0.4754|TWO_SIDED|95.0|-0.21|0.46|||MMRM|||Agitation, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.21|0.4754
70907234|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.163||0.7776|TWO_SIDED|95.0|-0.28|0.37|||MMRM|||Agitation, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.28|0.7776
70907235|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.213||0.7172|TWO_SIDED|95.0|-0.5|0.35|||MMRM|||Agitation, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.50|0.7172
70907236|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.203||0.4791|TWO_SIDED|95.0|-0.55|0.26|||MMRM|||Agitation, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.55|0.4791
70968642|NCT02819635|141443077|SUPERIORITY||Adjusted risk difference (%)|23.7|||<|0.001|TWO_SIDED|95.0|17.5|30.0||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||30.0|17.5|<0.001
70968643|NCT02819635|141443078|SUPERIORITY||Adjusted risk difference (%)|27.4|||<|0.001|TWO_SIDED|95.0|19.2|35.6||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||35.6|19.2|<0.001
70907237|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.164||0.3562|TWO_SIDED|95.0|-0.48|0.17|||MMRM|||Agitation, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.48|0.3562
71102624|NCT04875533|141713840|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.88|||||TWO_SIDED|95.0|0.76|1.02||||||Serotype 9V: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||1.02|0.76|
70907238|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.162||0.8859|TWO_SIDED|95.0|-0.3|0.34|||MMRM|||Agitation, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.34|-0.30|0.8859
70907239|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.192||0.5888|TWO_SIDED|95.0|-0.49|0.28|||MMRM|||Anxiety Psychic, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.49|0.5888
70907240|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.187||0.3992|TWO_SIDED|95.0|-0.53|0.21|||MMRM|||Anxiety Psychic, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.53|0.3992
70968644|NCT02819635|141443079|SUPERIORITY||Adjusted risk difference (%)|23.6|||<|0.001|TWO_SIDED|95.0|15.1|32.1||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||32.1|15.1|<0.001
70968645|NCT02819635|141443080|SUPERIORITY||Adjusted risk difference (%)|32.2|||<|0.001|TWO_SIDED|95.0|23.8|40.7||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||40.7|23.8|<0.001
70968646|NCT02819635|141443081|SUPERIORITY||Least Squares (LS) Mean Difference|33.7|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|27.02|40.36||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Mixed-effect model repeated measurement|MMRM with Baseline, treatment, visit, treatment-by-visit interaction, and strata (Baseline Adapted Mayo score, corticosteroid use, and bio-IR status).|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||40.36|27.02|<0.001
70968647|NCT02819635|141443082|SUPERIORITY||Adjusted risk difference (%)|9.7|||<|0.001|TWO_SIDED|95.0|5.7|13.7||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||13.7|5.7|<0.001
70968648|NCT02819635|141443083|SUPERIORITY||Least Squares (LS) Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|0.97|<|0.001|TWO_SIDED|95.0|4.79|8.59||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Mixed-effect model repeated measurement|MMRM with Baseline, treatment, visit, treatment-by-visit interaction, and strata (Baseline Adapted Mayo score, corticosteroid use, and bio-IR status)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||8.59|4.79|<0.001
70968649|NCT02819635|141443084|SUPERIORITY||Adjusted risk difference (%)|34.4|||<|0.001|TWO_SIDED|95.0|25.1|43.7||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||43.7|25.1|<0.001
70968650|NCT02819635|141443084|SUPERIORITY||Adjusted risk difference (%)|46.3|||<|0.001|TWO_SIDED|95.0|36.7|55.8||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||55.8|36.7|<0.001
70968651|NCT02819635|141443085|SUPERIORITY||Adjusted risk difference (%)|37.4|||<|0.001|TWO_SIDED|95.0|20.3|54.6||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||54.6|20.3|<0.001
71029768|NCT00406848|141567562|SUPERIORITY_OR_OTHER|||||||0.529||95.0||||p-value is for Core Mood subscale change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.529
70907241|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.227||0.1212|TWO_SIDED|95.0|-0.8|0.1|||MMRM|||Anxiety Psychic, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.80|0.1212
70968652|NCT02819635|141443085|SUPERIORITY||Adjusted risk difference (%)|47.0|||<|0.001|TWO_SIDED|95.0|30.7|63.3||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||63.3|30.7|<0.001
70968653|NCT02819635|141443086|SUPERIORITY||Adjusted risk difference (%)|35.4|||<|0.001|TWO_SIDED|95.0|18.2|52.7||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||52.7|18.2|<0.001
70968654|NCT02819635|141443086|SUPERIORITY||Adjusted risk difference (%)|45.1|||<|0.001|TWO_SIDED|95.0|28.7|61.6||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||61.6|28.7|<0.001
70968655|NCT02819635|141443087|SUPERIORITY||Adjusted risk difference (%)|42.0|||<|0.001|TWO_SIDED|95.0|27.8|56.2||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||56.2|27.8|<0.001
70968656|NCT02819635|141443087|SUPERIORITY||Adjusted risk difference (%)|48.6|||<|0.001|TWO_SIDED|95.0|35.5|61.7||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||61.7|35.5|<0.001
70968657|NCT02819635|141443088|SUPERIORITY||Adjusted risk difference (%)|18.7|||<|0.001|TWO_SIDED|95.0|11.0|26.4||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||26.4|11.0|<0.001
70968658|NCT02819635|141443088|SUPERIORITY||Adjusted risk difference (%)|19.4|||<|0.001|TWO_SIDED|95.0|11.7|27.2||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||27.2|11.7|<0.001
70968659|NCT02819635|141443089|SUPERIORITY||Adjusted risk difference (%)|44.6|||<|0.001|TWO_SIDED|95.0|34.5|54.7||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||54.7|34.5|<0.001
70968660|NCT02819635|141443089|SUPERIORITY||Adjusted risk difference (%)|56.6|||<|0.001|TWO_SIDED|95.0|47.2|66.0||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||66.0|47.2|<0.001
70968661|NCT02819635|141443090|SUPERIORITY||Adjusted risk difference (%)|23.8|||<|0.001|TWO_SIDED|95.0|14.8|32.8||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||32.8|14.8|<0.001
70968662|NCT02819635|141443090|SUPERIORITY||Adjusted risk difference (%)|37.3|||<|0.001|TWO_SIDED|95.0|27.8|46.8||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||46.8|27.8|<0.001
70968663|NCT02819635|141443091|SUPERIORITY||LS Mean Difference|31.3|STANDARD_ERROR_OF_MEAN|4.77|<|0.001|TWO_SIDED|95.0|21.98|40.7||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|ANCOVA|Stratified by corticosteroid use at Week 0 (yes/no); clinical remission status at Week 0 (yes/ no); Bio-IR status at Baseline (Bio-IR or Non-Bio-IR)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||40.70|21.98|<0.001
71029769|NCT00406848|141567562|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||p-value is for Core Mood subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.027
70968664|NCT02819635|141443091|SUPERIORITY||LS Mean Difference|41.0|STANDARD_ERROR_OF_MEAN|4.88|<|0.001|TWO_SIDED|95.0|31.39|50.55||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|ANCOVA|Stratified by corticosteroid use at Week 0 (yes/no); clinical remission status at Week 0 (yes/ no); Bio-IR status at Baseline (Bio-IR or Non-Bio-IR)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||50.55|31.39|<0.001
70968665|NCT02819635|141443092|SUPERIORITY||Adjusted risk difference (%)|13.0|||<|0.001|TWO_SIDED|95.0|6.0|20.0||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||20.0|6.0|<0.001
70968666|NCT02819635|141443092|SUPERIORITY||Adjusted risk difference (%)|13.6|||<|0.001|TWO_SIDED|95.0|6.6|20.6||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||20.6|6.6|<0.001
70968667|NCT02819635|141443093|SUPERIORITY||Adjusted risk difference (%)|38.7|||<|0.001|TWO_SIDED|95.0|28.9|48.5||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||48.5|28.9|<0.001
70968668|NCT02819635|141443093|SUPERIORITY||Adjusted risk difference (%)|45.1|||<|0.001|TWO_SIDED|95.0|35.5|54.8||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||54.8|35.5|<0.001
70968669|NCT02819635|141443094|SUPERIORITY||Adjusted risk difference (%)|24.3|||<|0.001|TWO_SIDED|95.0|14.2|34.5||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||34.5|14.2|<0.001
70968670|NCT02819635|141443094|SUPERIORITY||Adjusted risk difference (%)|33.7|||<|0.001|TWO_SIDED|95.0|23.6|43.9||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||43.9|23.6|<0.001
70968671|NCT02819635|141443095|SUPERIORITY||LS Mean Difference|5.1|||<|0.001|TWO_SIDED|95.0|2.67|7.52||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|ANCOVA|Stratified by corticosteroid use at Week 0 (yes/no); clinical remission status at Week 0 (yes/no); Bio-IR status at Baseline (Bio-IR or Non-Bio-IR)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||7.52|2.67|<0.001
70968672|NCT02819635|141443095|SUPERIORITY||LS Mean Difference|5.9|||<|0.001|TWO_SIDED|95.0|3.44|8.27||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|ANCOVA|Stratified by corticosteroid use at Week 0 (yes/no); clinical remission status at Week 0 (yes/no); Bio-IR status at Baseline (Bio-IR or Non-Bio-IR)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||8.27|3.44|<0.001
70968673|NCT01035099|141443096|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.31
71029770|NCT00406848|141567562|SUPERIORITY_OR_OTHER|||||||0.749||95.0||||p-value is for Anxiety/Somatization subscale change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.749
70968674|NCT01035099|141443097|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.19
70968675|NCT01035099|141443100|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.12
70968676|NCT01035099|141443101|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.77
70968677|NCT01035099|141443102|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.63
70968678|NCT01035099|141443104|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.14
70968679|NCT01035099|141443105|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||<0.0001
71029771|NCT00406848|141567562|SUPERIORITY_OR_OTHER|||||||0.296||95.0||||p-value is for Anxiety/Somatization subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.296
71029772|NCT00406848|141567562|SUPERIORITY_OR_OTHER|||||||0.984||95.0||||p-value is for Sleep subscale change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.984
70968680|NCT01035099|141443106|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.58
70968681|NCT01035099|141443108|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.42
70968682|NCT00632099|141443131|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher Exact|||||||<0.05
70968683|NCT01923285|141443139|NON_INFERIORITY|The non-inferiority margin, which is pre-specified at 10%. If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025.|||||<|0.0001||||||The non-inferiority margin, which is pre-specified at 10%. If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025.|Chi-squared|||"The primary hypothesis tested was: H0: p1 ≤ p0 - δ vs. H1: p1\> p0 - δ, where p0 is the success rate in the Control group, p1 is the success rate in the Axium group, and δ is the non-inferiority margin, which is pre-specified at 10%.~If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025."||||<0.0001
70968684|NCT01923285|141443139|SUPERIORITY|The non-inferiority margin, which is pre-specified at 10%. If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025|||||=|0.0004|||||||Chi-squared|||The primary hypothesis tested was: H0: p1 ≤ p0 - δ vs. H1: p1\> p0 - δ, where p0 is the success rate in the Control group, p1 is the success rate in the Axium group, and δ is the non-inferiority margin, which is pre-specified at 10%.||||=0.0004
70968685|NCT01923285|141443140|OTHER|Comparison of the mean difference. Difference in intensities is calculated as the supine paresthesia intensity minus the upright paresthesia intensity.|Mean Difference (Net)|1.9|||<|0.0001|TWO_SIDED|95.0|1.0|2.8|||Wilcoxon (Mann-Whitney)||Difference in paresthesia intensities is calculated as the supine paresthesia score minus the upright paresthesia score for each subject.|"Secondary endpoint compared the mean differences in upright and supine paresthesia scores between the Axium and Control groups at three months post INS implant. This endpoint was evaluated at a two-sided significance level of 0.05.~The primary hypothesis tested was: H0: μ0- μ1≤0 vs. H1: μ0- μ1\>0 where μ0 is the mean difference in paresthesia intensities in the Control group and μ1 is the mean difference in the Axium group."||2.8|1.0|<0.0001
70968686|NCT01923285|141443141|NON_INFERIORITY|If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025.|||||<|0.0001|||||||Chi-squared|||The primary hypothesis tested was: H0: p1 ≤ p0 - δ vs. H1: p1\> p0 - δ, where p0 is the success rate in the Control group, p1 is the success rate in the Axium group, and δ is the non-inferiority margin, which is pre-specified at 10%.||||<0.0001
70968687|NCT01923285|141443141|SUPERIORITY|If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025.|||||=|0.0047|||||||Chi-squared|||||||=0.0047
70968688|NCT01923285|141443142|NON_INFERIORITY|If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025.||||||0.0003|||||||Non-inferiority|||The primary hypothesis tested was: H0: p1 ≤ p0 - δ vs. H1: p1\> p0 - δ, where p0 is the success rate in the Control group, p1 is the success rate in the Axium group, and δ is the non-inferiority margin, which is pre-specified at 10%.||||0.0003
70968689|NCT00330382|141443151|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.11|||>|0.45|TWO_SIDED||||||Spearman Rank Correlation|||Correlation of percent change in buccal-cell Neu with relative percent change in total lesion area||||>0.45
70968690|NCT00330382|141443151|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.92|||>|0.88|TWO_SIDED||||||Spearman Rank Correlation|||Correlation of percent change in protease activity with relative percent change in total lesion area||||> 0.88
70968691|NCT00330382|141443151|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.07|||>|0.66|TWO_SIDED||||||Spearman Rank Correlation|||Correlation of percent change in serum Neu with relative percent change in total lesion area||||> 0.66
70968692|NCT03201458|141443184|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.027|TWO_SIDED|90.0|0.35|0.93||One-sided test|Log Rank|||||0.93|0.35|0.027
70968693|NCT03201458|141443185|SUPERIORITY||Odds Ratio (OR)|2.3||||0.22|TWO_SIDED||||||Fisher Exact|||||||0.22
70968694|NCT03201458|141443187|SUPERIORITY|||||||0.41||||||One-sided test|Log Rank|||||||0.410
70968695|NCT05112536|141443195|OTHER|||||||0.101|||||||Wilcoxon signed-rank test|||||||0.101
70968696|NCT04707157|141443198|SUPERIORITY||Posterior Mean Difference|-1.56|||||TWO_SIDED|95.0|-2.76|-0.38|||||Posterior mean difference with 95% credible interval is reported.|||-0.38|-2.76|
70968697|NCT04707157|141443199|SUPERIORITY||Posterior Mean Difference|-1.03|||||TWO_SIDED|95.0|-2.14|0.08|||||Posterior mean difference with 95% credible interval is reported.|||0.08|-2.14|
70968698|NCT04707157|141443200|SUPERIORITY||Posterior Mean Difference|-0.91|||||TWO_SIDED|95.0|-1.56|-0.25|||||Posterior mean difference with 95% credible interval is reported.|||-0.25|-1.56|
70968699|NCT04707157|141443201|SUPERIORITY||Posterior Mean Difference|-1.99|||||TWO_SIDED|95.0|-3.22|-0.77|||||Posterior mean difference with 95% credible interval is reported.|||-0.77|-3.22|
70968700|NCT04707157|141443202|SUPERIORITY||Posterior Mean Difference|-19.12|||||TWO_SIDED|95.0|-31.22|-6.97|||||Posterior mean difference with 95% credible interval is reported.|||-6.97|-31.22|
70968701|NCT04707157|141443203|SUPERIORITY||Posterior Mean Difference|-0.11|||||TWO_SIDED|95.0|-0.86|0.64|||||Posterior mean difference with 95% credible interval is reported.|||0.64|-0.86|
70968702|NCT04707157|141443204|SUPERIORITY||Posterior Mean Difference|-269.92|||||TWO_SIDED|95.0|-624.98|86.24|||||Posterior mean difference with 95% credible interval is reported.|||86.24|-624.98|
70968703|NCT04707157|141443205|SUPERIORITY||Posterior Mean Difference|0.03|||||TWO_SIDED|95.0|-0.22|0.29|||||Posterior mean difference with 95% credible interval is reported.|||0.29|-0.22|
70968704|NCT00804570|141443207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.3||||0.12|TWO_SIDED|95.0|-9.72|1.13|||Mixed Models Analysis|||||1.13|-9.72|0.120
70968705|NCT00804570|141443208|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.71||||0.013|TWO_SIDED|95.0|-1.27|-0.15|||Mixed Models Analysis|||||-0.15|-1.27|0.013
70968706|NCT00804570|141443209|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.37||||0.051|TWO_SIDED|95.0|-0.02|10.77|||Mixed Models Analysis|||||10.77|-0.02|0.051
70968707|NCT00804570|141443210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.249|TWO_SIDED|95.0|-1.07|0.28|||Mixed Models Analysis|||||0.28|-1.07|0.249
70968708|NCT00804570|141443211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44||||0.199|TWO_SIDED|95.0|-1.12|0.23|||Mixed Models Analysis|||||0.23|-1.12|0.199
70968709|NCT00804570|141443212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68||||0.318|TWO_SIDED|95.0|-2.03|0.66|||Mixed Models Analysis|||||0.66|-2.03|0.318
70968710|NCT00804570|141443213|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.01||||0.034|TWO_SIDED|95.0|-5.8|-0.22|||Mixed Models Analysis|||||-0.22|-5.80|0.034
70968711|NCT00804570|141443214|SUPERIORITY_OR_OTHER_LEGACY||GMR over Baseline relative to placebo|0.9||||0.001|TWO_SIDED|95.0|0.85|0.96|||Mixed Models Analysis|||||0.96|0.85|0.001
70968712|NCT00804570|141443215|SUPERIORITY_OR_OTHER_LEGACY||GMR over Baseline relative to placebo|0.96||||0.103|TWO_SIDED|95.0|0.91|1.01|||Mixed Models Analysis|||||1.01|0.91|0.103
70968713|NCT00804570|141443216|SUPERIORITY_OR_OTHER_LEGACY||GMR over Baseline relative to placebo|0.94||||0.012|TWO_SIDED|95.0|0.89|0.99|||Mixed Models Analysis|||||0.99|0.89|0.012
70968714|NCT00804570|141443217|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32||||0.392|TWO_SIDED|95.0|-1.05|0.41|||Mixed Models Analysis|||||0.41|-1.05|0.392
70968715|NCT00804570|141443218|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44||||0.185|TWO_SIDED|95.0|-1.1|0.21|||Mixed Models Analysis|||||0.21|-1.10|0.185
70968716|NCT00804570|141443219|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.25||||0.142|TWO_SIDED|95.0|-0.42|2.92|||ANCOVA|||||2.92|-0.42|0.142
70968717|NCT00804570|141443220|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48||||0.69|TWO_SIDED|95.0|-1.01|0.04||P-value is for desire to stop drinking at this time.|ANCOVA|||||0.04|-1.01|0.69
70968718|NCT00804570|141443220|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.545|TWO_SIDED|95.0|-0.85|0.45||P-value is for expectation of success in quitting alcohol.|ANCOVA|||||0.45|-0.85|0.545
70968719|NCT00804570|141443220|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48||||0.19|TWO_SIDED|95.0|-1.2|0.24||P-value is for difficulty to quit and remain abstinent.|ANCOVA|||||0.24|-1.20|0.190
70968720|NCT00804570|141443220|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04||||0.856|TWO_SIDED|95.0|-0.49|0.4||P-value is for goal related to alcohol use.|ANCOVA|||||0.40|-0.49|0.856
70968721|NCT00804570|141443221|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.77||||0.297|TWO_SIDED|95.0|-0.68|2.22|||Mixed Models Analysis|||||2.22|-0.68|0.297
70968722|NCT00804570|141443222|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.46||||0.633|TWO_SIDED|95.0|-1.44|2.36|||Mixed Models Analysis|||||2.36|-1.44|0.633
70968723|NCT00804570|141443225|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.77||||0.409|TWO_SIDED|95.0|-2.62|1.07||P-value is for supine systolic blood pressure.|Mixed Models Analysis|||||1.07|-2.62|0.409
70968724|NCT00804570|141443225|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45||||0.452|TWO_SIDED|95.0|-1.63|0.73||P-value is for supine diastolic blood pressure.|Mixed Models Analysis|||||0.73|-1.63|0.452
70968725|NCT00804570|141443226|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53||||0.456|TWO_SIDED|95.0|-1.93|0.87|||Mixed Models Analysis|||||0.87|-1.93|0.456
70968726|NCT00804570|141443227|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.08||||0.081|TWO_SIDED|95.0|-4.41|0.26|||Mixed Models Analysis|||||0.26|-4.41|0.081
70968727|NCT00804570|141443228|SUPERIORITY_OR_OTHER_LEGACY|||||||0.122||95.0|||||Fisher Exact|||||||0.122
70968728|NCT00804570|141443229|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||Fisher Exact|||||||0.002
70968729|NCT00804570|141443230|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.69||||0.235|TWO_SIDED|95.0|-1.82|0.45||P-value is for orthostatic systolic blood pressure.|Mixed Models Analysis|||||0.45|-1.82|0.235
70968730|NCT00804570|141443230|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31||||0.4|TWO_SIDED|95.0|-1.05|0.42||P-value is for orthostatic diastolic blood pressure.|Mixed Models Analysis|||||0.42|-1.05|0.400
70968731|NCT00804570|141443231|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.74||||0.077|TWO_SIDED|95.0|-0.08|1.57|||Mixed Models Analysis|||||1.57|-0.08|0.077
70968732|NCT00804570|141443233|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.57|||<|0.001|TWO_SIDED|95.0|0.24|0.9|||Mixed Models Analysis|||||0.90|0.24|<0.001
70968733|NCT00290342|141443234|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to diphtheria, standardized asymptotic 95% CI for the groups'difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-1.85|1.79||||||Non-inferiority in terms of vaccine response to diphteria||1.79|-1.85|
70968734|NCT00290342|141443234|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to tetanus, standardized asymptotic 95% CI for the groups'difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-1.85|1.79||||||Non-inferiority in terms of vaccine response to tetanus||1.79|-1.85|
70968735|NCT00290342|141443235|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to poliovirus type 1, standardized asymptotic 95% CI for the groups' difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-1.85|1.82||||||Immune response non-inferiority - Anti-Polio 1||1.82|-1.85|
70968736|NCT00290342|141443235|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to poliovirus type 2, standardized asymptotic 95% CI for the groups' difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.49|||||TWO_SIDED|95.0|-1.36|2.71||||||Immune response non-inferiority - Anti-Polio 2||2.71|-1.36|
71008703|NCT02055976|141525244|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.112|STANDARD_ERROR_OF_MEAN|2.909||0.081|TWO_SIDED|95.0|-1.671|9.895|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.895|-1.671|0.081
70968737|NCT00290342|141443235|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to poliovirus type 3, standardized asymptotic 95% CI for the groups' difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|-0.01|||||TWO_SIDED|95.0|-2.28|2.24||||||Immune response non-inferiority - Anti-Polio 3||2.24|-2.28|
70968738|NCT00290342|141443236|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to pertussis toxoid, standardized asymptotic 95% CI for the groups' difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|1.44|||||TWO_SIDED|95.0|-0.46|4.13||||||Immune response non-inferiority - Anti-PT||4.13|-0.46|
70968739|NCT00290342|141443236|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to filamentous haemagglutinin, standardized asymptotic 95% CI for the groups' difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.45|||||TWO_SIDED|95.0|-1.88|2.95||||||Immune response non-inferiority - Anti-FHA||2.95|-1.88|
70968740|NCT00290342|141443236|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to pertactin, standardized asymptotic 95% CI for the groups' difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.47|||||TWO_SIDED|95.0|-1.4|2.64||||||Immune response non-inferiority - Anti-PRN||2.64|-1.4|
70968741|NCT01056510|141443247|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Based on one-sided continuity corrected Chi-Square Test for participants achieving CR confirmed with biopsy versus those not achieving CR confirmed with biopsy|Chi-squared, Corrected|||The first-line subpopulation became the focus of the primary statistical analysis following the protocol amendment dated 21-May-2012.||||0.002
70968742|NCT01056510|141443248|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Based on one-sided continuity corrected Chi-Square Test for participants achieving CR confirmed with biopsy versus those not achieving CR confirmed with biopsy|Chi-squared, Corrected|||||||< 0.001
70968743|NCT01056510|141443249|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED|||||Based on one-sided continuity corrected Chi-Square Test for participants achieving CR confirmed with biopsy versus those not achieving CR confirmed with biopsy|Chi-squared, Corrected|||||||0.009
70968744|NCT01056510|141443250|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED|||||Based on two-sided continuity corrected Chi-Square Test|Chi-squared, Corrected|||After 3 cycles||||0.900
70968745|NCT01056510|141443250|SUPERIORITY_OR_OTHER|||||||0.563|TWO_SIDED|||||Based on two-sided continuity corrected Chi-Square Test|Chi-squared, Corrected|||After 6 cycles||||0.563
70968746|NCT01056510|141443250|SUPERIORITY_OR_OTHER|||||||0.304|TWO_SIDED|||||Based on two-sided continuity corrected Chi-Square Test|Chi-squared, Corrected|||At the EOT visit||||0.304
70968747|NCT01056510|141443253|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.525||||0.003|TWO_SIDED|95.0|0.341|0.809|||Log Rank|||Unstratified analysis||0.809|0.341|0.003
71029773|NCT00406848|141567562|SUPERIORITY_OR_OTHER|||||||0.93||95.0||||p-value is for Sleep subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.930
71029774|NCT00406848|141567562|SUPERIORITY_OR_OTHER|||||||0.934||95.0||||p-value is for Retardation subscale change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.934
71029775|NCT00406848|141567562|SUPERIORITY_OR_OTHER|||||||0.123||95.0||||p-value is for Retardation subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.123
71152280|NCT00123422|141796623|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED|||||Statistical tests were 2-sided and a p value of \< 0.05 was the criterion for statistical significance.|ANCOVA|The baseline value was the co-variate in this analysis.||||||0.015
70968748|NCT01056510|141443253|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.523||||0.003|TWO_SIDED|95.0|0.339|0.806|||Log Rank|||Stratified analysis: by baseline Binet stage||0.806|0.339|0.003
70968749|NCT01056510|141443255|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Log Rank|||||||0.029
70968750|NCT01056510|141443257|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Log Rank|||||||0.006
70968751|NCT01056510|141443259|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||Log Rank|||||||0.037
70968752|NCT01056510|141443261|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Log Rank|||||||0.007
70968753|NCT01056510|141443263|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.994||||0.986|TWO_SIDED|95.0|0.517|1.911||Unstratified analysis|Log Rank|||||1.911|0.517|0.986
70968754|NCT01056510|141443263|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.975||||0.939|TWO_SIDED|95.0|0.505|1.88|||Log Rank|||Stratified analysis: by baseline Binet stage||1.880|0.505|0.939
70968755|NCT01056510|141443264|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Based on two-sided continuity corrected Chi-Square Test|Chi-squared, Corrected|||||||< 0.001
70968756|NCT00243386|141443267|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6016||95.0|||||t-test, 2 sided|||A t-test was used to compare the means of the transformed data. The null-hypothesis tested was H0: X'A(PK-driven prophylaxis) - X'B (standard prophylaxis) = 0 (i.e., no difference for treatment under the 2 prophylactic regimens. X' = (ABR+0.5)\^(1/2)||||0.6016
70968757|NCT00243386|141443268|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||2-sided paired T-tests were done comparing transformed annualized bleeding rates between On-Demand and Prophylaxis regimens.|Paired t-Test|||||||<0.0001
70968758|NCT00243386|141443269|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||2-sided paired T-tests were done comparing transformed annualized bleeding rates between On-Demand and Prophylaxis regimens.|Paired t-test|||||||<0.0001
70968759|NCT00243386|141443270|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||2-sided paired T-tests were done comparing transformed annualized bleeding rates between On-Demand and Prophylaxis regimens.|Paired t-test|||||||<0.0001
70968760|NCT00243386|141443271|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4924||95.0|||||Wilcoxon-Rank Sum (Mann-Whitney)|||||||0.4924
70968761|NCT00243386|141443292|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1467||95.0|||||Wilcoxon-Rank Sum (Mann-Whitney)|||||||0.1467
70968762|NCT00243386|141443293|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007||95.0||||Due to multiple hypotheses testing results, adjusted alpha values are set to α\*=0.005 (0.05/10). Adjustments take into account 10 hypotheses tests between On-Demand and any Prophylaxis. Statistically significant results are considered p-values \< α\*|Wilcoxon signed-rank test|||||||0.0007
70968763|NCT00243386|141443294|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0||||Due to multiple hypotheses testing results, adjusted alpha values are set to α\*=0.005 (0.05/10). Adjustments take into account 10 hypotheses tests between On-Demand and any Prophylaxis. Statistically significant results are considered p-values \< α\*|Wilcoxon signed-rank test|||||||0.0002
70968764|NCT00243386|141443295|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon Signed-Rank Test|||||||<0.0001
70968765|NCT02285998|141443296|NON_INFERIORITY_OR_EQUIVALENCE|The sample size required to achieve 80% power was calculated based on a one-sided alpha level of 0.025 and an attack rate of 2% in the IIV4 and 1.53% for the Flublok groups respectively.|Relative Vaccine Efficacy (rVE)|30.0|||||TWO_SIDED|95.0|10.0|47.0||||||The primary efficacy analysis was based on the numbers of protocol-defined influenza-like illnesses with rtPCR-positive nasopharyngeal swabs detecting influenza virus of any strain. The Relative Vaccine Efficacy was 30% (10, 47). Non-inferiority would be concluded if the lower bound of the 95% CI for rVE was \> -20%. Superiority of RIV4 in a pre-specified exploratory analysis required that the lower bound of the two-sided 95% CI of rVE be \> +9%.||47|10|
70968766|NCT02662036|141443344|SUPERIORITY|||||||0.76|||||||Mann Whitney U Test|||Statistical analysis #1 is for intraoperative opioid use||||0.76
70968767|NCT02662036|141443344|SUPERIORITY|||||||0.38|||||||Mann Whitney U Test|||Statistical analysis #2 is for postoperative acute care unit opioid use||||0.38
70968768|NCT02662036|141443344|SUPERIORITY|||||||0.69|||||||Mann Whitney U Test|||Statistical analysis #3 is for postoperative floor opioid use||||0.69
70968769|NCT02662036|141443344|SUPERIORITY|||||||0.98|||||||Mann Whitney U Test|||Statistical analysis #4 is for total opioid use||||0.98
70968770|NCT02662036|141443345|SUPERIORITY|||||||0.28|||||||Mann Whitney U Test|||Statistical analysis #1 is for postoperative acute care unit antiemetic use||||0.28
70968771|NCT02662036|141443345|SUPERIORITY|||||||0.62|||||||Mann Whitney U Test|||Statistical analysis #2 is for floor antiemetic use||||0.62
70968772|NCT02662036|141443345|SUPERIORITY|||||||0.5|||||||Mann Whitney U Test|||Statistical analysis #3 is for total antiemetic use||||0.50
71152281|NCT00123422|141796624|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|The baseline value was the co-variate in this analysis.||||||<0.05
70968773|NCT02662036|141443346|SUPERIORITY|||||||0.2|||||||Mann Whitney U Test|||||||0.20
71102625|NCT04875533|141713840|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|1.09|||||TWO_SIDED|95.0|0.92|1.29||||||Serotype 14: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||1.29|0.92|
70968774|NCT02662036|141443347|SUPERIORITY|||||||0.64|||||||Mann Whitney U Test|||||||0.64
70968775|NCT02662036|141443348|SUPERIORITY|||||||0.38|||||||Mann Whitney U Test|||||||0.38
70968776|NCT04995055|141443356|SUPERIORITY||Least-square Mean Difference|-15.4|STANDARD_ERROR_OF_MEAN|2.81|||TWO_SIDED|95.0|-21.2|-9.5|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as senofilcon A (C3)- senofilcon A|||-9.5|-21.2|
70968777|NCT04995055|141443357|SUPERIORITY||Least-square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|0.2|0.4|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as senofilcon A (C3)- senofilcon A|||0.4|0.2|
70968778|NCT04995055|141443358|SUPERIORITY||Least-square Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-4.9|-2.1|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as senofilcon A (C3)- senofilcon A|||-2.1|-4.9|
70968779|NCT04995055|141443359|SUPERIORITY||Least-square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|0.2|0.4|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as senofilcon A (C3)- senofilcon A|||0.4|0.2|
70968780|NCT04995055|141443361|SUPERIORITY||Least-square Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|95.0|-4.4|-1.9|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as senofilcon A (C3)- senofilcon A|||-1.9|-4.4|
70968781|NCT03418129|141443363|SUPERIORITY||Slope|0.2331|STANDARD_ERROR_OF_MEAN|0.2176||0.2852|TWO_SIDED||||||ANCOVA||Multilevel modeling was used to model outcome at baseline and 3-month follow-up. Resulting slopes capture change in outcome from baseline to follow-up, with relaxation set as the comparison.|||||0.2852
70968782|NCT03418129|141443363|SUPERIORITY||Slope|0.03057|STANDARD_ERROR_OF_MEAN|0.2132||0.8861|TWO_SIDED||||||ANCOVA||Multilevel modeling was used to model outcome at baseline and 3-month follow-up. Resulting slopes capture change in outcome from baseline to follow-up, with relaxation set as the comparison.|||||0.8861
70968783|NCT03418129|141443364|SUPERIORITY||Slope|-0.03844|STANDARD_ERROR_OF_MEAN|0.09424||0.6842|TWO_SIDED||||||ANOVA||Multilevel modeling was used to model outcomes at two time points (3-month follow-up and baseline) and across three treatment groups (Mindfulness, Neurofeedback, and Relaxation).|||||0.6842
70968784|NCT03418129|141443364|SUPERIORITY||Slope|-0.1432|STANDARD_ERROR_OF_MEAN|0.09427||0.132|TWO_SIDED||||||ANOVA||Multilevel modeling was used to model outcomes at two time points (3-month follow-up and baseline) and across three treatment groups (Mindfulness, Neurofeedback, and Relaxation).|||||0.132
70968785|NCT03418129|141443365|SUPERIORITY||Slope|0.1911|STANDARD_ERROR_OF_MEAN|0.2551||0.4542|TWO_SIDED||||||ANCOVA|||||||0.4542
70968786|NCT03418129|141443365|SUPERIORITY||Slope|-0.3761|STANDARD_ERROR_OF_MEAN|0.2454||0.1261|TWO_SIDED||||||ANCOVA|||||||0.1261
70968787|NCT01553188|141443372|SUPERIORITY|||||||0.44|||||||Log rank two-tailed p-value|||||||0.44
70968788|NCT01553188|141443374|SUPERIORITY|||||||0.26|||||||Log rank two-tailed p-value|||||||0.26
71152282|NCT04555616|141796625|OTHER|||||||0.12|||||||Fisher Exact|||Primary outcome analyzed via success rates among groups.||||0.12
71152283|NCT03089281|141796628|SUPERIORITY|||||||0.17|||||||Chi-squared|||||||0.17
71152284|NCT03089281|141796629|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|||||||0.011
71152285|NCT03089281|141796630|SUPERIORITY|||||||0.029|||||||t-test, 2 sided|||||||0.029
70968789|NCT02186847|141443403|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.7563|TWO_SIDED|95.0|0.77|1.73|||Log Rank|One-sided significance level = 0.10|Reference level = Chemoradiation|The study was powered to detect an improvement of the 1-year progression-free survival rate from 50% (no metformin) to 65% (metformin) or equivalently a hazard ratio (HR) of 0.622, at one-sided type 1 error of 0.1 and 85% power with at least 102 progression-free survival events.||1.73|0.77|0.7563
70968790|NCT02186847|141443404|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.891|TWO_SIDED|95.0|0.64|1.68|||Log Rank|Two-sided significance level = 0.05|Reference level = Chemoradiation|||1.68|0.64|0.8910
70968791|NCT02186847|141443405|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.4075|TWO_SIDED|95.0|0.71|2.34|||Log Rank|Two-side significance level = 0.05|Reference level = Chemoradiation|||2.34|0.71|0.4075
70968792|NCT02186847|141443406|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.4075|TWO_SIDED|95.0|0.71|2.34|||Log Rank|Two-sided significance level = 0.05|Reference level = Chemoradiation|||2.34|0.71|0.4075
70968793|NCT02186847|141443407|SUPERIORITY||Odds Ratio (OR)|0.92||||0.6266|TWO_SIDED|95.0|0.47|1.8|||Chi-squared|Two-sided significance level = 0.05|Reference level = Chemoradiation|||1.80|0.47|0.6266
70968794|NCT00666458|141443429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.055|||TWO_SIDED|95.0|-0.01|0.2||||||||0.20|-0.01|
70968795|NCT00666458|141443430|SUPERIORITY_OR_OTHER||Difference in Percent|-2.8|||||TWO_SIDED|95.0|-9.0|3.5||||||||3.5|-9.0|
70968796|NCT00666458|141443431|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.42|STANDARD_ERROR_OF_MEAN|2.064|||TWO_SIDED|95.0|1.37|9.47||||||||9.47|1.37|
70968797|NCT00666458|141443432|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.115|||TWO_SIDED|95.0|0.08|0.53||||||||0.53|0.08|
70968798|NCT01417195|141443463|NON_INFERIORITY_OR_EQUIVALENCE|The pre-defined non-inferiority margin for the lower limit of the 95% CI for the difference in fertilization rate was below -12%.|Mean Difference (Final Values)|3.6|||||TWO_SIDED|95.0|-4.3|11.5|||||"Mean difference = Menopur/Bravelle - Menopur.~95% CI is based on Student's t-distribution, assuming equal variances."|||11.5|-4.3|
70968799|NCT03357731|141443469|SUPERIORITY||Mean Difference (Net)|-2.15|STANDARD_ERROR_OF_MEAN|0.9242||0.027|TWO_SIDED|95.0|-4.0432|-0.257|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||-0.2570|-4.0432|0.027
70968800|NCT03357731|141443470|SUPERIORITY||Mean Difference (Net)|0.193|STANDARD_ERROR_OF_MEAN|0.9832||0.846|TWO_SIDED|95.0|-1.8176|2.2042|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||2.2042|-1.8176|0.846
70968801|NCT03357731|141443471|SUPERIORITY||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|0.93||0.177|TWO_SIDED|95.0|-0.62|3.19|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||3.19|-0.62|0.177
71152286|NCT03089281|141796632|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.050
70968802|NCT03357731|141443471|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.48||0.839|TWO_SIDED|95.0|-1.08|0.88|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||0.88|-1.08|0.839
70968803|NCT03357731|141443472|SUPERIORITY||Mean Difference (Net)|-0.0977|STANDARD_ERROR_OF_MEAN|0.03308||0.007|TWO_SIDED|95.0|-0.16634|-0.02915|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||-0.02915|-0.16634|0.007
70968804|NCT03357731|141443472|SUPERIORITY||Mean Difference (Net)|-0.0371|STANDARD_ERROR_OF_MEAN|0.02194||0.103|TWO_SIDED|95.0|-0.08243|0.00814|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||0.00814|-0.08243|0.103
70968805|NCT03357731|141443473|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.037||0.003|TWO_SIDED|95.0|-0.205|-0.051|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|E/A ratio||-0.051|-0.205|0.003
70968806|NCT03357731|141443473|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.026||0.904|TWO_SIDED|95.0|-0.051|0.057|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|E/A ratio||0.057|-0.051|0.904
70968807|NCT03357731|141443473|SUPERIORITY||Mean Difference (Net)|-1.66|STANDARD_ERROR_OF_MEAN|0.527||0.006|TWO_SIDED|95.0|-2.763|-0.549|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|E/e' ratio||-0.549|-2.763|0.006
70968808|NCT03357731|141443473|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.392||0.503|TWO_SIDED|95.0|-1.085|0.55|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|E/e' ratio||0.550|-1.085|0.503
71029776|NCT00406848|141567563|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||p-value is for Severity of Worst Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.034
71029777|NCT00406848|141567563|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||p-value is for Severity of Worst Pain - Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.100
71152287|NCT03089281|141796633|SUPERIORITY|||||||0.49|||||||Cochran-Armitage Trend Test|||||||0.49
71152288|NCT03089281|141796634|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
70968809|NCT03357731|141443474|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.398||0.994|TWO_SIDED|95.0|-0.827|0.82|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|annular e' velocity||0.820|-0.827|0.994
70968810|NCT03357731|141443474|SUPERIORITY||Mean Difference (Net)|0.48|STANDARD_ERROR_OF_MEAN|0.258||0.073|TWO_SIDED|95.0|-0.049|1.013|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|annular e' velocity||1.013|-0.049|0.073
70968811|NCT03357731|141443475|SUPERIORITY||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.4||0.705|TWO_SIDED|95.0|-0.67|0.976|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||0.976|-0.670|0.705
70968812|NCT03357731|141443475|SUPERIORITY||Mean Difference (Net)|-0.68|STANDARD_ERROR_OF_MEAN|0.404||0.105|TWO_SIDED|95.0|-1.504|0.151|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||0.151|-1.504|0.105
70968813|NCT03118232|141443482|OTHER|The risk ratios reflect the risk of transfer to a hospital during the intervention period relative to the baseline period in each trial group.|Difference in Risk Ratio|16.6|||<|0.001|TWO_SIDED|95.0|11.0|21.8|||Mixed Models Analysis|||||21.8|11.0|<0.001
70968814|NCT03118232|141443483|OTHER|The risk ratios reflect the risk of transfer to a hospital during the intervention period relative to the baseline period in each trial group.|Difference in Risk Ratio|14.6|||<|0.001|TWO_SIDED|95.0|9.7|19.2|||Mixed Models Analysis|||||19.2|9.7|<0.001
70968815|NCT02918864|141443488|SUPERIORITY||Beta Coefficient|-0.22||||0.037|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SB=Group+Time+Group\*Time+ADHD+ γ + ε; ADHD, CASI T-score significant covariate), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.037
70968816|NCT02918864|141443490|SUPERIORITY||Beta Coefficient|-0.23||||0.016|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SB=Group+Time+Group\*Time+ADHD+ γ + ε; ADHD, CASI T-score significant covariate), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.016
70968817|NCT02918864|141443492|SUPERIORITY||Beta Coefficient|-0.16||||0.061|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SB=Group+Time+Group\*Time+ADHD+ γ + ε; ADHD, CASI T-score significant covariate), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.061
70968818|NCT02918864|141443494|SUPERIORITY||Beta Coefficient|0.03||||0.674|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SC=Group+Time+Group\*Time+Group\*VIQ+ γ + ε; VIQ, verbal intelligence quotient (VIQ) significant moderator), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.674
70968819|NCT02918864|141443496|SUPERIORITY||Beta Coefficient|0.09||||0.191|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SC=Group+Time+Group\*Time+Group\*VIQ+ γ + ε; VIQ, verbal intelligence quotient (VIQ) significant moderator), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.191
70968820|NCT02918864|141443498|SUPERIORITY||Beta Coefficient|0.04||||0.599|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SC=Group+Time+Group\*Time+Group\*VIQ+ γ + ε; VIQ, verbal intelligence quotient (VIQ) significant moderator), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||H0=No significant interaction of Group\*Time||||0.599
70968821|NCT02918864|141443500|SUPERIORITY|||||||0.462||||||2-sided p-value; p-value reported not adjusted for multiple tests (with different time points)|Fisher Exact|||"Ho=Group and response are independent (responders=improved scores of 1-2; non-responders=worsened scores of 5-7 on the CGI-I) at week 12"||||0.462
70968822|NCT02918864|141443501|SUPERIORITY|||||||1||||||2-sided p-value; p-value reported not adjusted for multiple tests (with different time points)|Fisher Exact|||"Ho=Group and response are independent (responders=improved scores of 1-2; non-responders=worsened scores of 5-7 on the CGI-I) at week 16"||||1.000
70968823|NCT02918864|141443502|SUPERIORITY|||||||0.607||||||2-sided p-value; p-value reported not adjusted for multiple tests (with different time points)|Fisher Exact|||"Ho=Group and response are independent (responders=improved scores of 1-2; non-responders=worsened scores of 5-7 on the CGI-I) at week 24"||||0.607
70968824|NCT02918864|141443503|SUPERIORITY||Beta Coefficient|-0.15||||0.31|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SRS=Group+Time+Group\*Time+VIQ+ γ + ε; VIQ, verbal IQ significant covariate), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.310
70968825|NCT02918864|141443505|SUPERIORITY||Beta Coefficient|-0.2||||0.115|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SRS=Group+Time+Group\*Time+VIQ+ γ + ε; VIQ, verbal IQ significant covariate), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.115
70968826|NCT02918864|141443507|SUPERIORITY||Beta Coefficient|-0.08||||0.455|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SRS=Group+Time+Group\*Time+VIQ+ γ + ε; VIQ, verbal IQ significant covariate), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.455
71152289|NCT03089281|141796635|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||||||0.21
71152290|NCT03089281|141796636|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|||||||0.34
71152291|NCT03089281|141796637|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
71152292|NCT03089281|141796638|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||0.45
71152293|NCT03089281|141796639|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||||||0.90
71152294|NCT03089281|141796640|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||||||0.59
70968827|NCT02918864|141443509|SUPERIORITY||Beta Coefficient|-0.14||||0.379|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (CGS=Group+Time+Group\*Time+ γ + ε), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.379
70968828|NCT02918864|141443511|SUPERIORITY||Beta Coefficient|-0.14||||0.275|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (CGS=Group+Time+Group\*Time+ γ + ε), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.275
70968829|NCT02918864|141443513|SUPERIORITY||Beta Coefficient|-0.2||||0.087|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (CGS=Group+Time+Group\*Time+ γ + ε), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||||||0.087
70968830|NCT03577730|141443521|OTHER||Median Difference (Final Values)|55.0||||0.092|TWO_SIDED|95.0|-9.0|118.0|||Generalized estimating equations||The median difference (+55) is an estimated difference between groups - rather than the actual difference - based on the pre-specified generalized estimated equations modeling.|||118|-9|0.092
70968831|NCT03577730|141443522|OTHER|||||||0.802|||||||Mixed Models Analysis|||Analysis for visual analog scale scores at rest presented.||||0.802
70968832|NCT03577730|141443523|OTHER|||||||0.32|||||||Mixed Models Analysis|||||||0.320
70968833|NCT03577730|141443524|OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||||||0.670
70968834|NCT03577730|141443525|OTHER|||||||0.595|||||||Fisher Exact|||||||0.595
70968835|NCT03577730|141443526|OTHER|||||||0.985|||||||Fisher Exact|||||||0.985
70968836|NCT03577730|141443527|OTHER|||||||0.417|||||||Wilcoxon (Mann-Whitney)|||||||0.417
70968837|NCT03577730|141443528|OTHER|||||||0.432|||||||Wilcoxon (Mann-Whitney)|||||||0.432
71152295|NCT04816669|141796641|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR is greater than 0.67.|Geometric mean ratio|0.68|||||TWO_SIDED|95.0|0.6|0.77|||||GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the concentrations BNT162b2 lyophilized SDV - BNT162b2 frozen-liquid MDV and the corresponding CI (based on the Student t distribution).|||0.77|0.60|
70968838|NCT03577730|141443529|OTHER|||||||0.673|||||||Wilcoxon (Mann-Whitney)|||||||0.673
70968839|NCT03577730|141443530|OTHER|||||||0.058|||||||Chi-squared|||||||0.058
70968840|NCT02634151|141443540|SUPERIORITY||LS Mean Difference|-11.05||||0.0057|TWO_SIDED|95.0|-18.81|-3.29|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||A 2-sided test with a significance level of 0.05 was used for the comparison.||-3.29|-18.81|0.0057
70968841|NCT02634151|141443541|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-11.8||||0.0648|TWO_SIDED|95.0|-24.35|0.75|||ANCOVA|Randomized treatment group and baseline diabetes status are included as factors, and the outcome at baseline is included as a covariate.||High-Intensity.||0.75|-24.35|0.0648
70968842|NCT02634151|141443541|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-10.64||||0.0398|TWO_SIDED|95.0|-20.77|-0.51|||ANCOVA|Randomized treatment group and baseline diabetes status are included as factors, and the outcome at baseline is included as a covariate.||Moderate Intensity.||-0.51|-20.77|0.0398
70968843|NCT02634151|141443542|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-10.09||||0.0275|TWO_SIDED|95.0|-19.04|-1.14|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-1.14|-19.04|0.0275
70968844|NCT02634151|141443542|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-9.4||||0.0524|TWO_SIDED|95.0|-18.9|0.1|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4.||0.10|-18.90|0.0524
70968845|NCT02634151|141443542|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.89||||0.8602|TWO_SIDED|95.0|-9.12|10.9|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||10.90|-9.12|0.8602
70968846|NCT02634151|141443542|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-12.63||||0.0115|TWO_SIDED|95.0|-22.37|-2.89|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-2.89|-22.37|0.0115
70968847|NCT02634151|141443542|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-5.87||||0.1945|TWO_SIDED|95.0|-14.79|3.05|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Average of week 8 and 12||3.05|-14.79|0.1945
70968848|NCT02634151|141443543|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-5.88||||0.0991|TWO_SIDED|95.0|-12.89|1.13|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||1.13|-12.89|0.0991
70968849|NCT02634151|141443544|OTHER|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-7.58||||0.0101|TWO_SIDED|95.0|-13.32|-1.84|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-1.84|-13.32|0.0101
70968850|NCT02634151|141443544|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-9.56||||0.0037|TWO_SIDED|95.0|-15.94|-3.18|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-3.18|-15.94|0.0037
70968851|NCT02634151|141443544|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.94||||0.7839|TWO_SIDED|95.0|-7.72|5.84|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||5.84|-7.72|0.7839
70968852|NCT02634151|141443544|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-10.69||||0.0025|TWO_SIDED|95.0|-17.53|-3.84|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-3.84|-17.53|0.0025
70907242|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.221||0.3185|TWO_SIDED|95.0|-0.66|0.22|||MMRM|||Anxiety Psychic, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.66|0.3185
70907243|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.231||0.4809|TWO_SIDED|95.0|-0.62|0.29|||MMRM|||Anxiety Psychic, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.62|0.4809
70907244|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.225||0.8953|TWO_SIDED|95.0|-0.42|0.48|||MMRM|||Anxiety Psychic, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.48|-0.42|0.8953
70907245|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.223||0.5616|TWO_SIDED|95.0|-0.57|0.31|||MMRM|||Anxiety Psychic, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.57|0.5616
70907246|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.216||0.8571|TWO_SIDED|95.0|-0.39|0.47|||MMRM|||Anxiety Psychic, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.47|-0.39|0.8571
70907247|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.213||0.0037|TWO_SIDED|95.0|-1.05|-0.21|||MMRM|||Anxiety Psychic, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.21|-1.05|0.0037
70907248|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.206||0.0386|TWO_SIDED|95.0|-0.84|-0.02|||MMRM|||Anxiety Psychic, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-0.84|0.0386
70907249|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.216||0.0044|TWO_SIDED|95.0|-1.05|-0.2|||MMRM|||Anxiety Psychic, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.20|-1.05|0.0044
70907250|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.208||0.8308|TWO_SIDED|95.0|-0.46|0.37|||MMRM|||Anxiety Psychic, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.46|0.8308
70907251|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.215||0.0388|TWO_SIDED|95.0|-0.87|-0.02|||MMRM|||Anxiety Psychic, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-0.87|0.0388
70968853|NCT02634151|141443545|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-12.66||||0.0117|TWO_SIDED|95.0|-22.45|-2.88|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-2.88|-22.45|0.0117
71102626|NCT04875533|141713840|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.73|||||TWO_SIDED|95.0|0.62|0.85||||||Serotype 18C: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.85|0.62|
70907252|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.209||0.1622|TWO_SIDED|95.0|-0.71|0.12|||MMRM|||Anxiety Psychic, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.71|0.1622
70907253|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.204||0.0179|TWO_SIDED|95.0|-0.89|-0.09|||MMRM|||Anxiety Psychic, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-0.89|0.0179
70968854|NCT02634151|141443545|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-15.55||||0.0036|TWO_SIDED|95.0|-25.88|-5.21|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-5.21|-25.88|0.0036
70968855|NCT02634151|141443545|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.59||||0.9147|TWO_SIDED|95.0|-11.48|10.31||Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.|ANCOVA|||Week 8||10.31|-11.48|0.9147
70968856|NCT02634151|141443545|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-16.59||||0.0026|TWO_SIDED|95.0|-27.24|-5.93|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-5.93|-27.24|0.0026
70968857|NCT02634151|141443546|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-6.13||||0.0101|TWO_SIDED|95.0|-10.77|-1.5|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-1.50|-10.77|0.0101
70968858|NCT02634151|141443546|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-7.73||||0.0036|TWO_SIDED|95.0|-12.89|-2.58|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-2.58|-12.89|0.0036
70968859|NCT02634151|141443546|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.12||||0.9653|TWO_SIDED|95.0|-5.27|5.51|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||5.51|-5.27|0.9653
70968860|NCT02634151|141443546|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-6.89||||0.0101|TWO_SIDED|95.0|-12.1|-1.68|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-1.68|-12.10|0.0101
70968861|NCT02634151|141443547|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-12.74||||0.0173|TWO_SIDED|95.0|-23.19|-2.3|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-2.30|-23.19|0.0173
70968862|NCT02634151|141443547|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-16.29||||0.0038|TWO_SIDED|95.0|-27.17|-5.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-5.40|-27.17|0.0038
70968863|NCT02634151|141443547|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.58||||0.7846|TWO_SIDED|95.0|-9.85|13.01|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||13.01|-9.85|0.7846
70968864|NCT02634151|141443547|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-13.98||||0.0121|TWO_SIDED|95.0|-24.83|-3.13|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-3.13|-24.83|0.0121
70968865|NCT02634151|141443548|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-13.32||||0.0108|TWO_SIDED|95.0|-23.32|-3.12|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-3.12|-23.32|0.0108
70968866|NCT02634151|141443548|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-23.6|||<|0.0001|TWO_SIDED|95.0|-34.78|-12.42|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-12.42|-34.78|<0.0001
70968867|NCT02634151|141443548|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-6.71||||0.1376|TWO_SIDED|95.0|-15.6|2.18|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||2.18|-15.60|0.1376
70968868|NCT02634151|141443548|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-15.64||||0.0144|TWO_SIDED|95.0|-28.1|-3.18|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||-3.18|-28.10|0.0144
70968869|NCT02634151|141443549|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-19.53||||0.0113|TWO_SIDED|95.0|-34.55|-4.51|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-4.51|-34.55|0.0113
70968870|NCT02634151|141443549|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-33.64||||0.0002|TWO_SIDED|95.0|-50.58|-16.69|||ANCOVA|||Week 4||-16.69|-50.58|0.0002
70968871|NCT02634151|141443549|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-8.33||||0.1873|TWO_SIDED|95.0|-20.77|4.12|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||4.12|-20.77|0.1873
70968872|NCT02634151|141443549|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-29.58||||0.0172|TWO_SIDED|95.0|-53.8|-5.37|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-5.37|-53.80|0.0172
70968873|NCT02634151|141443550|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-11.52||||0.021|TWO_SIDED|95.0|-21.27|-1.77|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-1.77|-21.27|0.0210
70968874|NCT02634151|141443550|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-23.01|||<|0.0001|TWO_SIDED|95.0|-34.02|-12.01|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-12.01|-34.02|<0.0001
70968875|NCT02634151|141443550|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-6.43||||0.1483|TWO_SIDED|95.0|-15.19|2.33|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||2.33|-15.19|0.1483
70968876|NCT02634151|141443550|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-11.63||||0.0214|TWO_SIDED|95.0|-21.5|-1.76|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-1.76|-21.50|0.0214
70968877|NCT02634151|141443551|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-2.95||||0.0308|TWO_SIDED|95.0|-5.62|-0.28|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-0.28|-5.62|0.0308
70968878|NCT02634151|141443551|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-6.3||||0.0002|TWO_SIDED|95.0|-9.56|-3.04|||ANCOVA|A 2-sided test with a significance level of 0.05 was used for the comparison.||Week 4||-3.04|-9.56|0.0002
70968879|NCT02634151|141443551|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-1.58||||0.2056|TWO_SIDED|95.0|-4.03|0.88|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||0.88|-4.03|0.2056
70968880|NCT02634151|141443551|SUPERIORITY||LS Mean Difference|-4.0||||0.0103|TWO_SIDED|95.0|-7.04|-0.96|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-0.96|-7.04|0.0103
70968881|NCT02634151|141443552|SUPERIORITY||LS Mean Difference|-2.13||||0.3193|TWO_SIDED|95.0|-6.36|2.09|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||2.09|-6.36|0.3193
70968882|NCT02634151|141443552|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-2.4||||0.2932|TWO_SIDED|95.0|-6.91|2.11|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||2.11|-6.91|0.2932
70968883|NCT02634151|141443552|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.98||||0.4383|TWO_SIDED|95.0|-3.06|7.02|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||7.02|-3.06|0.4383
70968884|NCT02634151|141443552|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|2.78||||0.2814|TWO_SIDED|95.0|-2.31|7.86|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||7.86|-2.31|0.2814
70968885|NCT02634151|141443553|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.92||||0.4278|TWO_SIDED|95.0|-3.23|1.38|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||1.38|-3.23|0.4278
70968886|NCT02634151|141443553|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-1.13||||0.3529|TWO_SIDED|95.0|-3.53|1.27|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||1.27|-3.53|0.3529
70968887|NCT02634151|141443553|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.24||||0.3522|TWO_SIDED|95.0|-1.39|3.86|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||3.86|-1.39|0.3522
70968888|NCT02634151|141443553|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.6||||0.2635|TWO_SIDED|95.0|-1.22|4.42|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||4.42|-1.22|0.2635
71029778|NCT00406848|141567563|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||p-value is for Severity of Least Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.009
70968889|NCT02634151|141443554|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|2.23||||0.0464|TWO_SIDED|95.0|1.01|4.93|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||4.93|1.01|0.0464
70968890|NCT02634151|141443554|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|1.3||||0.5278|TWO_SIDED|95.0|0.58|2.92|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||2.92|0.58|0.5278
70968891|NCT02634151|141443554|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|2.36||||0.0359|TWO_SIDED|95.0|1.06|5.27|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||5.27|1.06|0.0359
70968892|NCT02634151|141443555|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|2.5||||0.0268|TWO_SIDED|95.0|1.11|5.61|||Regression, Logistic|||Week 4||5.61|1.11|0.0268
70968893|NCT02634151|141443555|SUPERIORITY||Odds Ratio (OR)|1.55||||0.2755|TWO_SIDED|95.0|0.7|3.41|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||3.41|0.70|0.2755
70968894|NCT02634151|141443555|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|4.74||||0.0003|TWO_SIDED|95.0|2.05|10.94|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||10.94|2.05|0.0003
70968895|NCT02634151|141443556|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|3.26||||0.0079|TWO_SIDED|95.0|1.36|7.8|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||7.80|1.36|0.0079
70907254|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.198||0.4283|TWO_SIDED|95.0|-0.55|0.24|||MMRM|||Anxiety Psychic, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.55|0.4283
70968896|NCT02634151|141443556|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|1.44||||0.4002|TWO_SIDED|95.0|0.62|3.35|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||3.35|0.62|0.4002
70968897|NCT02634151|141443556|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|3.09||||0.0142|TWO_SIDED|95.0|1.25|7.59|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||7.59|1.25|0.0142
70968898|NCT02634151|141443557|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|3.7||||0.0115|TWO_SIDED|95.0|1.34|10.2|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||10.20|1.34|0.0115
70968899|NCT02634151|141443557|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|1.15||||0.7566|TWO_SIDED|95.0|0.48|2.75|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||2.75|0.48|0.7566
70968900|NCT02634151|141443557|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|2.96||||0.0298|TWO_SIDED|95.0|1.11|7.88|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||7.88|1.11|0.0298
70968901|NCT02634151|141443558|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-10.4||||0.0029|TWO_SIDED|95.0|-17.2|-3.7|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-3.7|-17.2|0.0029
70968902|NCT02634151|141443558|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-4.3||||0.1666|TWO_SIDED|95.0|-10.4|1.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||1.8|-10.4|0.1666
70968903|NCT02634151|141443558|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-11.5||||0.001|TWO_SIDED|95.0|-18.2|-4.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-4.8|-18.2|0.0010
70968904|NCT02634151|141443559|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-10.7||||0.0018|TWO_SIDED|95.0|-17.3|-4.1|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-4.1|-17.3|0.0018
70968905|NCT02634151|141443559|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-3.8||||0.2437|TWO_SIDED|95.0|-10.1|2.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||2.6|-10.1|0.2437
70968906|NCT02634151|141443559|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-11.6||||0.0012|TWO_SIDED|95.0|-18.5|-4.7|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-4.7|-18.5|0.0012
70968907|NCT02634151|141443560|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.7||||0.6832|TWO_SIDED|95.0|-4.2|2.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||2.8|-4.2|0.6832
70968908|NCT02634151|141443560|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.8||||0.674|TWO_SIDED|95.0|-2.9|4.5|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||4.5|-2.9|0.6740
70968909|NCT02634151|141443560|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.9||||0.3379|TWO_SIDED|95.0|-2.0|5.7|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||5.7|-2.0|0.3379
70968910|NCT02634151|141443561|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.7||||0.7753|TWO_SIDED|95.0|-5.9|4.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||4.4|-5.9|0.7753
70968911|NCT02634151|141443561|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.7||||0.5472|TWO_SIDED|95.0|-3.9|7.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||7.4|-3.9|0.5472
70968912|NCT02634151|141443561|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|3.6||||0.2406|TWO_SIDED|95.0|-2.4|9.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||9.6|-2.4|0.2406
70968913|NCT02634151|141443562|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.2||||0.9028|TWO_SIDED|95.0|-3.3|3.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||3.8|-3.3|0.9028
70968914|NCT02634151|141443562|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|5.2||||0.0199|TWO_SIDED|95.0|0.8|9.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||9.6|0.8|0.0199
70968915|NCT02634151|141443562|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|4.6||||0.0369|TWO_SIDED|95.0|0.3|8.9|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||8.9|0.3|0.0369
70968916|NCT02634151|141443563|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.1||||0.911|TWO_SIDED|95.0|-1.2|1.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||1.4|-1.2|0.9110
70968917|NCT02634151|141443563|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.9||||0.0243|TWO_SIDED|95.0|0.3|3.5|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||3.5|0.3|0.0243
70968918|NCT02634151|141443563|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.7||||0.0388|TWO_SIDED|95.0|0.1|3.2|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||3.2|0.1|0.0388
70907255|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.219||0.1899|TWO_SIDED|95.0|-0.72|0.15|||MMRM|||Anxiety Psychic, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.72|0.1899
70968919|NCT02634151|141443564|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|7.0||||0.2799|TWO_SIDED|95.0|-5.7|19.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||19.6|-5.7|0.2799
70968920|NCT02634151|141443564|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|26.8||||0.0018|TWO_SIDED|95.0|10.2|43.3|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||43.3|10.2|0.0018
70968921|NCT02634151|141443564|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|20.1||||0.0197|TWO_SIDED|95.0|3.3|36.9|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||36.9|3.3|0.0197
70968922|NCT02634151|141443565|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.6||||0.0179|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||1.0|0.1|0.0179
70968923|NCT02634151|141443565|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.1||||0.0003|TWO_SIDED|95.0|0.5|1.7|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||1.7|0.5|0.0003
70968924|NCT02634151|141443565|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.8||||0.0095|TWO_SIDED|95.0|0.2|1.5|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||1.5|0.2|0.0095
70968925|NCT02634151|141443566|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-12.2||||0.0057|TWO_SIDED|95.0|-20.8|-3.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-3.6|-20.8|0.0057
70968926|NCT02634151|141443566|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.2||||0.9665|TWO_SIDED|95.0|-8.3|8.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||8.6|-8.3|0.9665
70968927|NCT02634151|141443566|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-6.2||||0.2358|TWO_SIDED|95.0|-16.4|4.1|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||4.1|-16.4|0.2358
70968928|NCT02634151|141443567|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-1.3||||0.0048|TWO_SIDED|95.0|-2.3|-0.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-0.4|-2.3|0.0048
70968929|NCT02634151|141443567|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.1||||0.9064|TWO_SIDED|95.0|-0.9|0.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||0.8|-0.9|0.9064
70968930|NCT02634151|141443567|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.6||||0.2505|TWO_SIDED|95.0|-1.7|0.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||0.4|-1.7|0.2505
70968931|NCT02634151|141443568|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-15.8|||<|0.0001|TWO_SIDED|95.0|-22.6|-9.0|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-9.0|-22.6|<0.0001
70968932|NCT02634151|141443568|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-7.2||||0.0406|TWO_SIDED|95.0|-14.0|-0.3|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||-0.3|-14.0|0.0406
70968933|NCT02634151|141443568|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-15.3|||<|0.0001|TWO_SIDED|95.0|-22.8|-7.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-7.8|-22.8|<0.0001
70968934|NCT02634151|141443569|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-0.3|-0.9|<0.0001
70968935|NCT02634151|141443569|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.3||||0.0771|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||0.0|-0.6|0.0771
71029779|NCT00406848|141567563|SUPERIORITY_OR_OTHER|||||||0.126||95.0||||p-value is for Severity of Least Pain Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.126
70968936|NCT02634151|141443569|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.6||||0.0006|TWO_SIDED|95.0|-1.0|-0.3|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-0.3|-1.0|0.0006
70968937|NCT02634151|141443570|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|8.6||||0.121|TWO_SIDED|95.0|-2.3|19.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||19.6|-2.3|0.1210
71029780|NCT00406848|141567563|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Severity of Average Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||<0.001
71029781|NCT00406848|141567563|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||p-value is for Severity of Average Pain Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.013
70968938|NCT02634151|141443570|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|8.0||||0.0948|TWO_SIDED|95.0|-1.4|17.3|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||17.3|-1.4|0.0948
70968939|NCT02634151|141443570|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|4.1||||0.5113|TWO_SIDED|95.0|-8.2|16.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||16.4|-8.2|0.5113
70968940|NCT02634151|141443571|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.7||||0.7276|TWO_SIDED|95.0|-7.8|11.1|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||11.1|-7.8|0.7276
70968941|NCT02634151|141443571|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|4.7||||0.2218|TWO_SIDED|95.0|-2.9|12.2|||ANCOVA|||Week 8||12.2|-2.9|0.2218
71029782|NCT00406848|141567563|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||p-value is for Severity of Pain Right Now Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.016
70907256|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.213||0.8022|TWO_SIDED|95.0|-0.48|0.37|||MMRM|||Anxiety Psychic, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.48|0.8022
70968942|NCT02634151|141443571|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.3||||0.942|TWO_SIDED|95.0|-9.2|9.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||9.8|-9.2|0.9420
70968943|NCT02634151|141443572|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|32.57||||0.6786|TWO_SIDED|95.0|-122.98|188.12|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||188.12|-122.98|0.6786
70968944|NCT02634151|141443573|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.84||||0.1648|TWO_SIDED|95.0|-2.03|0.35|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||0.35|-2.03|0.1648
70968945|NCT02634151|141443574|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|41.5||||0.4701|TWO_SIDED|95.0|-72.1|155.1|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||155.1|-72.1|0.4701
70968946|NCT02634151|141443575|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-32.4||||0.0517|TWO_SIDED|95.0|-65.1|0.2|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||0.2|-65.1|0.0517
70968947|NCT02634151|141443576|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-9.5||||0.9111|TWO_SIDED|95.0|-177.8|158.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||158.8|-177.8|0.9111
70968948|NCT02634151|141443577|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-3.0||||0.3864|TWO_SIDED|95.0|-10.0|3.9|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||3.9|-10.0|0.3864
70968949|NCT02634151|141443578|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|12.2||||0.0145|TWO_SIDED|95.0|2.5|22.0|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||22.0|2.5|0.0145
70968950|NCT02634151|141443579|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.8||||0.051|TWO_SIDED|95.0|0.0|1.5|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||1.5|-0.0|0.0510
70968951|NCT00676676|141443596|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Baseline versus 2-week||||0.002
70968952|NCT00676676|141443596|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||Baseline versus 8-week||||0.004
70968953|NCT03129321|141443597|EQUIVALENCE|Equivalence margin: +/-20%|Difference in proportions|4.24|||||TWO_SIDED|90.0|-5.05|13.54||||||||13.54|-5.05|
70968954|NCT03129321|141443598|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70968955|NCT03129321|141443598|SUPERIORITY|||||||0.0004|||||||Cochran-Mantel-Haenszel|||||||0.0004
70968956|NCT03129321|141443599|EQUIVALENCE|Equivalence margin: +/-20%|Difference in proportions|2.85|||||TWO_SIDED|90.0|-6.29|11.98||||||||11.98|-6.29|
70968957|NCT03129321|141443600|EQUIVALENCE|Equivalence margin: +/-20%|Difference in proportions|-0.02|||||TWO_SIDED|90.0|-8.29|8.26||||||||8.26|-8.29|
70968958|NCT03129321|141443601|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|||||||0.0020
70968959|NCT03129321|141443601|SUPERIORITY|||||||0.0076|||||||Cochran-Mantel-Haenszel|||||||0.0076
70968960|NCT03129321|141443602|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70968961|NCT03129321|141443602|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70968962|NCT01148537|141443618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.91|||<|0.001|TWO_SIDED|90.0|3.4|8.4|||ANCOVA|ANCOVA model with baseline QTci as a covariate and with sex and treatment as effects in the model.||||8.4|3.4|< .001
70968963|NCT01148537|141443619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.77|TWO_SIDED|90.0|-1.8|2.6|||ANCOVA||For the comparison of BTDS to placebo, the subjects randomized to moxifloxacin were excluded.|||2.6|-1.8|.770
70968964|NCT01148537|141443620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.86|||<|0.001|TWO_SIDED|90.0|3.3|8.4|||ANCOVA|ANCOVA model with baseline QTci as a covariate and with sex and treatment as effects in the model.||Day 13 analysis||8.4|3.3|< .001
70968965|NCT01148537|141443621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.64|||<|0.001|TWO_SIDED|90.0|5.4|9.9|||ANCOVA|ANCOVA model with average baseline as a covariate, and with gender and treatment as main effects||||9.9|5.4|< .001
70968966|NCT01148537|141443622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.936|TWO_SIDED|90.0|-2.9|2.6|||ANCOVA|||Day 6 analysis||2.6|-2.9|.936
70968967|NCT01148537|141443622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.16|||<|0.001|TWO_SIDED|90.0|4.2|10.1|||ANCOVA|||Day 13 analysis||10.1|4.2|< .001
70968968|NCT01148537|141443623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.23|||<|0.001|TWO_SIDED|90.0|5.5|10.9|||ANCOVA|||Day 6 analysis||10.9|5.5|< .001
70968969|NCT01148537|141443623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.4|||<|0.001|TWO_SIDED|90.0|4.3|10.5|||ANCOVA|||Day 13 analysis||10.5|4.3|< .001
70968970|NCT01148537|141443624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29||||0.427|TWO_SIDED|90.0|-1.4|4.0|||ANCOVA|||Day 6 analysis||4.0|-1.4|.427
70968971|NCT01148537|141443624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.01||||0.001|TWO_SIDED|90.0|3.2|8.8|||ANCOVA|||Day 13 analysis||8.8|3.2|.001
70968972|NCT01148537|141443625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.86|||<|0.001|TWO_SIDED|90.0|4.2|9.6|||ANCOVA|||Day 6 analysis||9.6|4.2|< .001
70968973|NCT01148537|141443625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.68||||0.006|TWO_SIDED|90.0|1.9|7.4|||ANCOVA|||Day 13 analysis||7.4|1.9|.006
70968974|NCT00393887|141443628|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Fisher Exact|||Two-sided Fisher's exact test||||0.11
71029783|NCT00406848|141567563|SUPERIORITY_OR_OTHER|||||||0.058||95.0||||p-value is for Severity of Pain Right Now Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.058
71029784|NCT00406848|141567563|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||p-value is for Interference with General Activity Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.011
71029785|NCT00406848|141567563|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||p-value is for Interference with General Activity Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.060
71029786|NCT00406848|141567563|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Interference with Mood Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||<0.001
71029787|NCT00406848|141567563|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value is for Interference with Mood Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.002
70968975|NCT03503877|141443629|SUPERIORITY|||||||0.07|||||||Wilcoxon signed-rank testing|||||||0.07
70968976|NCT03503877|141443630|SUPERIORITY|||||||0.89|||||||Wilcoxon signed-rank testing|||||||0.89
70968977|NCT03503877|141443631|SUPERIORITY|||||||0.54||||||High mosaicism|Wilcoxon signed-rank testing|||||||0.54
71029788|NCT00406848|141567563|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||p-value is for Interference with Walking Ability Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.019
70968978|NCT03503877|141443631|SUPERIORITY|||||||0.2||||||Low mosaicism|Wilcoxon signed-rank|||||||.20
70968979|NCT03503877|141443632|SUPERIORITY|||||||0.01||||||Time to Expanded Blastocyst|Wilcoxon signed-rank testing|||||||0.01
70968980|NCT02018822|141443635|NON_INFERIORITY|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.2552|||||||Chi-squared|||||||0.2552
70968981|NCT02018822|141443636|NON_INFERIORITY|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.2235|||||||Chi-squared|||||||0.2235
70968982|NCT02018822|141443637|NON_INFERIORITY|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.3891|||||||Chi-squared|||||||0.3891
70968983|NCT02018822|141443638|NON_INFERIORITY|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.3883|||||||Chi-squared|||||||0.3883
70968984|NCT02018822|141443639|NON_INFERIORITY|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.3883|||||||Chi-squared|||||||0.3883
70968985|NCT02018822|141443640|NON_INFERIORITY|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.2707|||||||Chi-squared|||||||0.2707
70968986|NCT04744207|141443654|SUPERIORITY||Least squares mean estimate|0.81|||<|0.05|TWO_SIDED|95.0|-2.48|4.1|||ANCOVA|||||4.10|-2.48|<0.05
70968987|NCT00777101|141443707|NON_INFERIORITY|Non-inferiority of neratinib vs lapatinib + capecitabine was to be concluded if the upper limit of the 95% confidence interval (CI) for the hazard ratio was 1.15 or less.|Hazard Ratio (HR)|1.19||||0.231|TWO_SIDED|95.0|0.89|1.6|||Log Rank|The log-rank test comparing treatment groups is stratified by region.|The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by region.|||1.60|0.89|0.231
71029789|NCT00406848|141567563|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||p-value is for Interference with Walking Ability Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.040
70968988|NCT05376215|141443739|NON_INFERIORITY|The non-inferiority margin of -12.5 was used per the findings from Chisolm, et al (2005), see attached article. In that study, the smallest critical difference for the short term retest difference was 12.5 for the APHAB global score at the 90th percentile. For this study, non-inferiority is confirmed if Fitting Method B is no more than 12.5 percentage points below the mean global benefit score of Fitting Method A.||||||0.806|||||||Mixed Models Analysis|||||||0.806
70968989|NCT05376215|141443740|NON_INFERIORITY|The non-inferiority margin is -1.8 dB. This is based off of work by Killion (2004) in which the critical difference for 4 lists is 1.9 dB at the 95% confidence interval. Killion also found that if all 12 lists are presented, the mean SNR scores will differ by 1.8 dB 5% of the time.||||||0.889|||||||Mixed Models Analysis|||||||0.889
70968990|NCT01947816|141443743|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 24||||< 0.0001
70968991|NCT01947816|141443743|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 52||||< 0.0001
70968992|NCT01947816|141443743|SUPERIORITY|||||||0.5512|||||||paired t-test|||Change from Baseline When Discontinued||||0.5512
70968993|NCT01947816|141443743|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Final Assessment||||< 0.0001
70968994|NCT01947816|141443745|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 4||||< 0.0001
70968995|NCT01947816|141443745|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 8||||< 0.0001
70968996|NCT01947816|141443745|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 16||||< 0.0001
70968997|NCT01947816|141443745|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 24||||< 0.0001
70968998|NCT01947816|141443745|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 52||||< 0.0001
70968999|NCT01947816|141443745|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline when discontinued||||< 0.0001
70969000|NCT01947816|141443745|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Final Assessment||||< 0.0001
70907257|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.215||0.378|TWO_SIDED|95.0|-0.62|0.24|||MMRM|||Anxiety Psychic, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.62|0.3780
70969001|NCT01301950|141443750|SUPERIORITY_OR_OTHER|||||||0.54|||||||ANOVA|||The null hypothesis was no difference in skin-to-skin time. The alternative hypothesis was that the TruMatch group time was less than the conventional group. Statistical power was anticipated to be 86% with 40 enrolled subjects based upon a Cohen's D effect size of 1. The Sponsor had difficulty identifying and recruiting sites suitable for participation. The statistically required sample size (N=40) was therefore not obtained, causing the group comparison to be statistically underpowered.||||0.54
70969002|NCT02651584|141443755|NON_INFERIORITY|The p-value was based on the chi square test for non-inferiority with the margin of 10% point.|||||<|0.001|||||||Chi-squared|||||||<0.001
70969003|NCT02651584|141443756|SUPERIORITY|||||||0.004|||||||Wilcoxon Rank-Sum|||including subject self-reported opioid use||||0.004
70969004|NCT02651584|141443756|SUPERIORITY|||||||0.008|||||||Wilcoxon Rank-Sum|||not including self-reported opioid use||||0.008
70969005|NCT02651584|141443758|NON_INFERIORITY_OR_EQUIVALENCE|The p-value was based on the chi square test for non-inferiority with the margin of 15%.||||||0.006|||||||Chi-squared|||||||0.006
70969006|NCT03455491|141443759|SUPERIORITY|||||||0.3541|||||||Gekhan-Wilcoxon test|||||||0.3541
70969007|NCT03455491|141443760|SUPERIORITY|||||||0.3597|||||||Gekhan-Wilcoxon test|||||||0.3597
70969008|NCT03455491|141443762|SUPERIORITY|||||||0.4551|||||||ANOVA|one-way ANOVA||||||0.4551
70969009|NCT01519765|141443811|SUPERIORITY_OR_OTHER|||||||0.1611|||||||Fisher Exact|||A consecutive sample will be used as women are recruited. Based on an 80% power and an alpha of 0.05, a sample size of 103 subjects in each arm is required to detect a 20% difference between deliveries within 24hrs between the two treatment arms. An effect size of 20% was selected as this is thought to be a clinically significant difference. This is based on the Wing study showing 50% delivery within 24 hrs with vaginal misoprostol.||||0.1611
70969010|NCT01519765|141443812|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||t-test, 2 sided|||||||0.018
70969011|NCT01519765|141443813|SUPERIORITY_OR_OTHER|||||||0.0623|||||||Kruskal-Wallis|||||||0.0623
70969012|NCT01519765|141443814|SUPERIORITY_OR_OTHER|||||||0.1141|TWO_SIDED||||||Kruskal-Wallis|||||||0.1141
70969013|NCT01519765|141443815|SUPERIORITY_OR_OTHER|||||||0.4469|TWO_SIDED||||||Fisher Exact|||||||0.4469
70969014|NCT01519765|141443816|SUPERIORITY_OR_OTHER|||||||0.4469|TWO_SIDED||||||Fisher Exact|||||||0.4469
70969015|NCT01519765|141443817|SUPERIORITY_OR_OTHER|||||||0.093|TWO_SIDED||||||Kruskal-Wallis|||||||0.093
70969016|NCT01519765|141443818|SUPERIORITY_OR_OTHER|||||||0.2417|TWO_SIDED||||||Fisher Exact|||||||0.2417
70969017|NCT01519765|141443819|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1
70969018|NCT01519765|141443820|SUPERIORITY_OR_OTHER|||||||0.1054|TWO_SIDED||||||Fisher Exact|||||||0.1054
70969019|NCT01519765|141443821|SUPERIORITY_OR_OTHER|||||||0.8043|TWO_SIDED||||||Fisher Exact|||||||0.8043
70969020|NCT01519765|141443822|SUPERIORITY_OR_OTHER|||||||0.797|TWO_SIDED||||||Fisher Exact|||||||0.797
70969021|NCT01519765|141443823|SUPERIORITY_OR_OTHER|||||||0.751|||||||Fisher Exact|||||||0.751
70969022|NCT01519765|141443824|SUPERIORITY_OR_OTHER|||||||0.6244|TWO_SIDED||||||Fisher Exact|||||||0.6244
70969023|NCT01519765|141443825|SUPERIORITY_OR_OTHER|||||||0.7906|TWO_SIDED||||||Fisher Exact|||||||0.7906
70969024|NCT01519765|141443826|SUPERIORITY_OR_OTHER|||||||0.5118|TWO_SIDED||||||Fisher Exact|||||||0.5118
70969025|NCT01519765|141443827|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1
70969026|NCT01519765|141443828|SUPERIORITY_OR_OTHER|||||||0.741|TWO_SIDED||||||Fisher Exact|||||||0.741
70969027|NCT01519765|141443829|SUPERIORITY_OR_OTHER|||||||0.579|TWO_SIDED||||||Kruskal-Wallis|||||||0.579
70969028|NCT01519765|141443830|SUPERIORITY_OR_OTHER|||||||0.8062|||||||Kruskal-Wallis|||Score for Nausea and vomiting||||.8062
70969029|NCT01519765|141443830|SUPERIORITY_OR_OTHER|||||||0.1505|||||||Kruskal-Wallis|||Effectiveness||||0.1505
70969030|NCT01519765|141443830|SUPERIORITY_OR_OTHER|||||||0.1223|||||||Kruskal-Wallis|||Patient concern||||0.1223
70969031|NCT01519765|141443830|SUPERIORITY_OR_OTHER|||||||0.538||||||Patient satisfaction|Kruskal-Wallis|||Labor satisfaction||||0.5380
70969032|NCT01519765|141443831|SUPERIORITY_OR_OTHER|||||||0.2868||||||This is the overall p value of all rows.|Chi-squared|||||||0.2868
70969033|NCT01699542|141443849|SUPERIORITY|||||||0.159|||||||Generalized Linear Model|||||||0.159
70969034|NCT05248295|141443876|OTHER|Separate regression models were used within each group (People with aphasia and Controls) to independently assess the effects of the variables. Below, the results are reported for the effect of production condition (Unison vs. Solo) for the group of interest, People with aphasia.|Odds Ratio (OR)|1.21|STANDARD_ERROR_OF_MEAN|0.13||0.077|TWO_SIDED|||||Results are reported for production condition for people with aphasia (experimental group).|Regression, Logistic||OR computed with Unison as the numerator and Solo as the denominator|People with aphasia (PWA) were not directly compared to controls since the finding of a lower % syllables correct in any condition in PWA would be trivial. Instead, within-groups analyses were conducted to understand how the experimental variables affected syllable accuracy within each group.||||0.077
70969035|NCT05248295|141443876|OTHER|Below, the results are reported for the effect of timing condition (Metrical vs. Conversational) for the group of interest, People with aphasia.|||||>|0.1||||||Results are reported for Timing Condition for the People with aphasia.|Regression, Logistic|||||||>.1
70969036|NCT05248295|141443876|OTHER|Below, the results are reported for the interaction effect between production condition and timing condition for the group of interest, People with aphasia.|Odds Ratio (OR)|1.55|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED||||||Regression, Logistic||OR computed as ((Unison Metrical)/(Unison Conversational)) / ((Solo Metrical)/(Solo Conversational))|||||<0.001
70969037|NCT05248295|141443876|OTHER||Odds Ratio (OR)|0.63|STANDARD_ERROR_OF_MEAN|0.14||0.036|TWO_SIDED|||||Results are reported for Production Condition for the Control group.|Regression, Logistic||OR computed with Unison as the numerator and Solo as the denominator|Separate regression models were used within each group. Here, the results are reported for the Control group.||||0.036
70969038|NCT05248295|141443876|OTHER|Below, the results are reported for the effect of timing condition (Metrical vs. Conversational) for the control group.|Odds Ratio (OR)|3.36|STANDARD_ERROR_OF_MEAN|1.19|<|0.001|TWO_SIDED||||||Regression, Logistic||OR computed with Metrical as the numerator and Conversational as the denominator|||||<0.001
70969039|NCT05248295|141443876|OTHER|Below, the results are reported for the interaction effect between production condition and timing condition for the control group.|||||>|0.1|||||||Regression, Logistic|||||||>.1
70969040|NCT05248295|141443877|OTHER|Separate regression models were used within each group (People with aphasia and Controls) to independently assess the effects of Timing Condition. Production Condition is not included in the analysis since all timing data are from the unison production condition, by definition.|Slope|-0.14|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||Results are reported for people with aphasia (experimental group).|Regression, Linear|||People with aphasia were not directly compared to Controls since the Control group is a context-providing reference group rather than a true comparator. Instead, within-groups analyses were conducted to understand how the experimental variable affected timing alignment in each group.||||<0.001
70969041|NCT05248295|141443877|OTHER||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.0|<|0.001|TWO_SIDED|||||Results are reported for the Control group.|Regression, Linear|||People with aphasia were not directly compared to Controls since the Control group is a context-providing reference group and not a true comparator. Instead, within-groups analyses were conducted to understand how experimental variables affected timing alignment in each group.||||<0.001
70969042|NCT03021499|141443878|SUPERIORITY||Odds Ratio (OR)|2.65|||<|0.001|TWO_SIDED|95.0|1.64|4.27|||Regression, Logistic|The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and Region.||The primary endpoint was the proportion of subjects showing renal response at Week 52 as adjudicated by the Clinical Endpoints Committee.||4.27|1.64|<0.001
70969043|NCT03021499|141443879|SUPERIORITY||Hazard Ratio (HR)|2.02|||<|0.001|TWO_SIDED|95.0|1.51|2.7|||Log Rank|||||2.7|1.51|<0.001
70969044|NCT03021499|141443881|SUPERIORITY||Odds Ratio (OR)|2.23||||0.002|TWO_SIDED|95.0|1.34|3.72|||Regression, Cox||The hazard ratios are from a Cox's proportional hazards model with terms for treatment arm, baseline UPCR, biopsy class, MMF use at baseline and Region|||3.72|1.34|0.002
70969045|NCT03021499|141443882|SUPERIORITY||Odds Ratio (OR)|2.43|||<|0.001|TWO_SIDED|95.0|1.56|3.79||Week 24|Regression, Logistic||Week 24|Week 24||3.79|1.56|<0.001
70969046|NCT03021499|141443882|SUPERIORITY||Odds Ratio (OR)|2.26|||<|0.001|TWO_SIDED|95.0|1.45|3.51||Week 52|Regression, Logistic||Week 52|Week 52||3.51|1.45|<0.001
70969047|NCT03021499|141443883|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.349|TWO_SIDED|95.0|0.53|1.25|||Regression, Cox|||||1.25|0.53|0.349
70969048|NCT03021499|141443883|SUPERIORITY|||||||0.646|||||||Log Rank|||||||0.646
70969049|NCT03021499|141443886|SUPERIORITY||Hazard Ratio (HR)|2.05|||<|0.001|TWO_SIDED|95.0|1.62|2.6|||Log Rank|||||2.6|1.62|<0.001
70969050|NCT03021499|141443887|SUPERIORITY||Mean Difference (Least Squares)|-4.6|STANDARD_ERROR_OF_MEAN|1.39|<|0.001|TWO_SIDED|95.0|-7.3|-1.9|||Mixed Models Analysis|||Week 2||-1.9|-7.3|< 0.001
70969051|NCT03021499|141443887|SUPERIORITY||Mean Difference (Least Squares)|-3.4|STANDARD_ERROR_OF_MEAN|1.39||0.014|TWO_SIDED|95.0|-6.1|-0.7|||Mixed Models Analysis|||Week 4||-0.7|-6.1|0.014
70969052|NCT03021499|141443887|SUPERIORITY||Mean Difference (Least Squares)|-4.6|STANDARD_ERROR_OF_MEAN|1.39|<|0.001|TWO_SIDED|95.0|-7.3|-1.9|||Mixed Models Analysis|||Week 8||-1.9|-7.3|< 0.001
70969053|NCT03021499|141443887|SUPERIORITY||Mean Difference (Least Squares)|-3.3|STANDARD_ERROR_OF_MEAN|1.39||0.017|TWO_SIDED|95.0|-6.0|-0.6|||Mixed Models Analysis|||Week 12||-0.6|-6|0.017
70969054|NCT03021499|141443887|SUPERIORITY||Mean Difference (Least Squares)|-2.4|STANDARD_ERROR_OF_MEAN|1.4||0.085|TWO_SIDED|95.0|-5.1|0.3|||Mixed Models Analysis|||Week 16||0.3|-5.1|0.085
70969055|NCT03021499|141443887|SUPERIORITY||Mean Difference (Least Squares)|-3.0|STANDARD_ERROR_OF_MEAN|1.4||0.035|TWO_SIDED|95.0|-5.7|-0.2|||Mixed Models Analysis|||Week 20||-0.2|-5.7|0.035
70969056|NCT03021499|141443887|SUPERIORITY||Mean Difference (Least Squares)|-2.2|STANDARD_ERROR_OF_MEAN|1.41||0.121|TWO_SIDED|95.0|-5.0|0.6|||Mixed Models Analysis|||Week 24||0.6|-5|0.121
70969057|NCT03021499|141443887|SUPERIORITY||Mean Difference (Least Squares)|-2.2|STANDARD_ERROR_OF_MEAN|1.42||0.12|TWO_SIDED|95.0|-5.0|0.6|||Mixed Models Analysis|||Week 30||0.6|-5|0.12
70969058|NCT03021499|141443887|SUPERIORITY||Mean Difference (Least Squares)|-2.3|STANDARD_ERROR_OF_MEAN|1.43||0.102|TWO_SIDED|95.0|-5.1|0.5|||Mixed Models Analysis|||Week 36||0.5|-5.1|0.102
71152296|NCT04816669|141796649|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR is greater than 0.67|Geometric mean ratio|1.14|||||TWO_SIDED|95.0|0.77|1.68|||||GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the concentrations BNT162b2 frozen-liquid LNP - BNT162b2 frozen-liquid RTU and the corresponding CI (based on the Student t distribution).|||1.68|0.77|
70969059|NCT03021499|141443887|SUPERIORITY||Mean Difference (Least Squares)|-3.3|STANDARD_ERROR_OF_MEAN|1.44||0.022|TWO_SIDED|95.0|-6.1|0.5|||Mixed Models Analysis|||Week 42||0.5|-6.1|0.022
70969060|NCT03021499|141443887|SUPERIORITY||Mean Difference (Least Squares)|-4.1|STANDARD_ERROR_OF_MEAN|1.45||0.004|TWO_SIDED|95.0|-7.0|-1.3|||Mixed Models Analysis|||Week 48||-1.3|-7|0.004
70969061|NCT03021499|141443887|SUPERIORITY||Mean Difference (Least Squares)|-2.8|STANDARD_ERROR_OF_MEAN|1.46||0.055|TWO_SIDED|95.0|-5.7|0.1|||Mixed Models Analysis|||Week 52||0.1|-5.7|0.055
70969062|NCT03021499|141443888|SUPERIORITY||Mean Difference (Least Squares)|-0.56|STANDARD_ERROR_OF_MEAN|0.181||0.011|TWO_SIDED|95.0|-1.0|-0.13|||Mixed Models Analysis|||Week 2||-0.13|-1|0.011
71029790|NCT00406848|141567563|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||p-value is for Interference with Normal Work Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.003
71029791|NCT00406848|141567563|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||p-value is for Interference with Normal Work Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.014
70969063|NCT03021499|141443888|SUPERIORITY||Mean Difference (Least Squares)|-0.76|STANDARD_ERROR_OF_MEAN|0.187|<|0.001|TWO_SIDED|95.0|-1.13|-0.4|||Mixed Models Analysis|||Week 4||-0.4|-1.13|<0.001
70969064|NCT03021499|141443888|SUPERIORITY||Mean Difference (Least Squares)|-0.7|STANDARD_ERROR_OF_MEAN|0.181|<|0.001|TWO_SIDED|95.0|-1.05|-0.34|||Mixed Models Analysis|||Week 8||-0.34|-1.05|<0.001
70969065|NCT03021499|141443888|SUPERIORITY||Mean Difference (Least Squares)|-0.94|STANDARD_ERROR_OF_MEAN|0.196|<|0.001|TWO_SIDED|95.0|-1.33|-0.55|||Mixed Models Analysis|||Week 12||-0.55|-1.33|<0.001
70969066|NCT03021499|141443888|SUPERIORITY||Mean Difference (Least Squares)|-1.18|STANDARD_ERROR_OF_MEAN|0.214|<|0.001|TWO_SIDED|95.0|-1.6|-0.76|||Mixed Models Analysis|||Week 16||-0.76|-1.6|<0.001
70969067|NCT03021499|141443888|SUPERIORITY||Mean Difference (Least Squares)|-1.16|STANDARD_ERROR_OF_MEAN|0.241|<|0.001|TWO_SIDED|95.0|-1.63|-0.68|||Mixed Models Analysis|||Week 20||-0.68|-1.63|<0.001
70969068|NCT03021499|141443888|SUPERIORITY||Mean Difference (Least Squares)|-1.15|STANDARD_ERROR_OF_MEAN|0.222|<|0.001|TWO_SIDED|95.0|-1.59|-0.72|||Mixed Models Analysis|||Week 24||-0.72|-1.59|<0.001
71029792|NCT00406848|141567563|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||p-value is for Interference with Relations with Other People Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.010
71029793|NCT00406848|141567563|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||p-value is for Interference with Relations with Other People Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.010
70969069|NCT03021499|141443888|SUPERIORITY||Mean Difference (Least Squares)|-1.02|STANDARD_ERROR_OF_MEAN|0.284|<|0.001|TWO_SIDED|95.0|-1.58|-0.46|||Mixed Models Analysis|||Week 30||-0.46|-1.58|<0.001
70969070|NCT03021499|141443888|SUPERIORITY||Mean Difference (Least Squares)|-1.21|STANDARD_ERROR_OF_MEAN|0.264|<|0.001|TWO_SIDED|95.0|-1.73|-0.69|||Mixed Models Analysis|||Week 36||-0.69|-1.73|<0.001
70969071|NCT03021499|141443888|SUPERIORITY||Mean Difference (Least Squares)|-1.37|STANDARD_ERROR_OF_MEAN|0.256|<|0.001|TWO_SIDED|95.0|-1.87|-0.86|||Mixed Models Analysis|||Week 42||-0.86|-1.87|<0.001
70969072|NCT03021499|141443888|SUPERIORITY||Mean Difference (Least Squares)|-1.06|STANDARD_ERROR_OF_MEAN|0.256|<|0.001|TWO_SIDED|95.0|-1.56|-0.55|||Mixed Models Analysis|||Week 48||-0.55|-1.56|<0.001
70969073|NCT03021499|141443888|SUPERIORITY||Mean Difference (Least Squares)|-0.99|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.52|-0.46|||Mixed Models Analysis|||Week 52||-0.46|-1.52|<0.001
70969074|NCT03021499|141443889|SUPERIORITY||Odds Ratio (OR)|2.44||||0.008|TWO_SIDED|95.0|1.26|4.71||Week 24|Regression, Logistic||Week 24|Week 24||4.71|1.26|0.008
70969075|NCT03021499|141443889|SUPERIORITY||Odds Ratio (OR)|2.44|||<|0.001|TWO_SIDED|95.0|1.48|4.0||Week 52|Regression, Logistic||Week 52|Week 52||4.00|1.48|<0.001
70969076|NCT03021499|141443890|SUPERIORITY||Least Squares Mean difference|-0.5||||0.373|TWO_SIDED|95.0|-1.6|0.6||Week 24|Mixed Models Analysis||Week 24|Week 24||0.6|-1.6|0.373
70969077|NCT03021499|141443890|SUPERIORITY||Least Squares Mean difference|-0.5||||0.277|TWO_SIDED|95.0|-1.4|0.4||Week 52|Mixed Models Analysis||Week 52|Week 52||0.4|-1.4|0.277
70969078|NCT03021499|141443891|SUPERIORITY||Slope|-0.47|STANDARD_ERROR_OF_MEAN|1.389||0.733|TWO_SIDED|95.0|-3.21|2.26|||Mixed Models Analysis|||SF-36 Change from Baseline Week 24||2.26|-3.21|0.733
70969079|NCT03021499|141443891|SUPERIORITY||Mean Difference (Least Squares)|-0.37|STANDARD_ERROR_OF_MEAN|1.481||0.801|TWO_SIDED|95.0|-3.29|2.54|||Mixed Models Analysis|||SF-36 Change from Baseline at Week 52||2.54|-3.29|0.801
70969080|NCT03021499|141443891|SUPERIORITY||Mean Difference (Least Squares)|1.7|STANDARD_ERROR_OF_MEAN|1.442||0.239|TWO_SIDED|95.0|-1.14|4.54|||Mixed Models Analysis|||LupusPRO HRQOL Change from Baseline at Week 24||4.54|-1.14|0.239
70969081|NCT03021499|141443891|SUPERIORITY||Mean Difference (Least Squares)|-0.6|STANDARD_ERROR_OF_MEAN|1.535||0.695|TWO_SIDED|95.0|-3.62|2.42|||Mixed Models Analysis|||LupusPRO HRQOL Change from Baseline at Week 52||2.42|-3.62|0.695
70969082|NCT03021499|141443891|SUPERIORITY||Mean Difference (Least Squares)|-1.89|STANDARD_ERROR_OF_MEAN|1.439||0.19|TWO_SIDED|95.0|-4.72|0.94|||Mixed Models Analysis|||LupusPRO non-HRQOL Change from Baseline at Week 24||0.94|-4.72|0.19
71029794|NCT00406848|141567563|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||p-value is for Interference with Sleep Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.015
71029795|NCT00406848|141567563|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||p-value is for Interference with Sleep Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.005
71029796|NCT00406848|141567563|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Interference with Enjoyment of Life Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||<0.001
71029797|NCT00406848|141567563|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Interference with Enjoyment of Life Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||<0.001
71029798|NCT00406848|141567563|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Average Interference Score Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||<0.001
71029799|NCT00406848|141567563|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||p-value is for Average Interference Score Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.001
71029800|NCT00406848|141567564|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||p-value is for Overall Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||.005
71152297|NCT01229267|141796657|SUPERIORITY||Vaccine Efficacy|0.638|||||TWO_SIDED|95.0|0.484|0.746|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age), and intended duration of antiviral prophylaxis (≤3 versus 3 to 6 months after auto-HCT).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 consistency lot group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% confidence interval (CI) is \>0.25.||0.746|0.484|
71029801|NCT00406848|141567564|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||p-value is for Overall Pain Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.204
70907258|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.21||0.811|TWO_SIDED|95.0|-0.47|0.36|||MMRM|||Anxiety Psychic, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.36|-0.47|0.8110
71029802|NCT00406848|141567564|SUPERIORITY_OR_OTHER|||||||0.078||95.0||||p-value is for Headaches Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.078
71029803|NCT00406848|141567564|SUPERIORITY_OR_OTHER|||||||0.147||95.0||||p-value is for Headaches Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.147
71029804|NCT00406848|141567564|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||p-value is for Back Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.007
71029805|NCT00406848|141567564|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||p-value is for Back Pain Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.013
71090937|NCT05233761|141688242|SUPERIORITY|The mean nightly difference in SWS + REM sleep (% TST) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority.|Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.6||0.035|TWO_SIDED|95.0|0.1|2.5|||t-test, 2 sided|||The null hypothesis was that there was no difference in SWS + REM (% TST) sleep in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||2.5|0.1|0.0350
70969083|NCT03021499|141443891|SUPERIORITY||Mean Difference (Least Squares)|0.826|STANDARD_ERROR_OF_MEAN|1.531||0.826|TWO_SIDED|95.0|-2.67|3.35|||Mixed Models Analysis|||LupusPRO non-HRQOL Change from Baseline at Week 52||3.35|-2.67|0.826
70969084|NCT04869345|141443931|SUPERIORITY||Odds Ratio (OR)|0.67||||0.684|TWO_SIDED|95.0|0.13|3.05||A priori threshold for statistical significance = 0.05.|Boschloo Test||Maximum likelihood estimate of the Odds Ratio comparing retention rate in LARKSPUR group to Attention Control group|||3.05|0.13|.684
71029806|NCT00406848|141567564|SUPERIORITY_OR_OTHER|||||||0.124||95.0||||p-value is for Shoulder Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.124
70907259|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.272||0.8908|TWO_SIDED|95.0|-0.58|0.5|||MMRM|||Anxiety Psychic, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.50|-0.58|0.8908
71029807|NCT00406848|141567564|SUPERIORITY_OR_OTHER|||||||0.231||95.0||||p-value is for Shoulder Pain Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.231
71029808|NCT00406848|141567564|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||p-value is for Interference with Daily Activities Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.006
71029809|NCT00406848|141567564|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||p-value is for Interference with Daily Activities Week 25 main effect of treatment.|Mixed Models Analysis|Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit||||||0.019
71029810|NCT00406848|141567564|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value is for Time in Pain While Awake Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.002
71029811|NCT00406848|141567564|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||p-value is for Time in Pain While Awake Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.036
71029812|NCT00406848|141567565|SUPERIORITY_OR_OTHER|||||||0.214||95.0||||p-value is for PGI-I at Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: PGI-I = Treatment + Pooled Investigator + Visit + Treatment\* Visit||||||0.214
71029813|NCT00406848|141567565|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||p-value is for PGI-I at Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: PGI-I = Treatment + Pooled Investigator + Visit + Treatment\* Visit||||||.063
71029814|NCT00406848|141567566|SUPERIORITY_OR_OTHER|||||||0.162||95.0||||p-value is for change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||.162
71029815|NCT00406848|141567566|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||p-value is for change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||.009
71029816|NCT00406848|141567567|SUPERIORITY_OR_OTHER|||||||0.555||95.0||||p-value is for change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline||||||0.555
71029817|NCT00406848|141567567|SUPERIORITY_OR_OTHER|||||||0.785||95.0||||p-value is for change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline||||||.785
71029818|NCT00406848|141567568|SUPERIORITY_OR_OTHER|||||||0.255||95.0||||p-value is for change from baseline (Week 1) to Week 13.|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline||||||0.255
71029819|NCT00406848|141567568|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||p-value is for change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline||||||0.038
71029820|NCT00406848|141567569|SUPERIORITY_OR_OTHER|||||||0.706||95.0||||p-values for Week 13 remission (HAMD17 ≤ 7).|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Remission = Treatment + Pooled Investigator + Visit + Baseline + Treatment\*Visit.||||||0.706
71029821|NCT00406848|141567569|SUPERIORITY_OR_OTHER|||||||0.694||95.0||||p-values for Week 25 Remission HAMD17 ≤ 7|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model:Remission = Treatment + Pooled Investigator + Visit + Baseline + Treatment\*Visit.||||||0.694
71029822|NCT00406848|141567569|SUPERIORITY_OR_OTHER|||||||0.864||95.0||||p-values for Week 13 Remission - HAMD17 ≤ 10|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model:Remission = Treatment + Pooled Investigator + Visit + Baseline + Treatment\*Visit.||||||0.864
71029823|NCT00406848|141567569|SUPERIORITY_OR_OTHER|||||||0.817||95.0||||p-values for Week 25 Remission - HAMD17 ≤ 10|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model:Remission = Treatment + Pooled Investigator + Visit + Baseline + Treatment\*Visit.||||||0.817
71029824|NCT00406848|141567570|SUPERIORITY_OR_OTHER|||||||0.664||95.0||||p-value is for probability of response at Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model:Response = Treatment + Pooled Investigator + Visit + Baseline + Treatment\*Visit.||||||0.664
71029825|NCT00406848|141567570|SUPERIORITY_OR_OTHER|||||||0.31||95.0||||p-value is for probability of response at Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model:Response = Treatment + Pooled Investigator + Visit + Baseline + Treatment\*Visit.||||||0.310
71029826|NCT00406848|141567572|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model: Onset = Treatment + Visit + Baseline + Treatment\*Visit.||||||0.036
71029827|NCT00406848|141567573|SUPERIORITY_OR_OTHER|||||||0.637||95.0||||p-value is for Systolic BP change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.637
71029828|NCT00406848|141567573|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||p-value is for Diastolic BP change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.001
71029829|NCT00406848|141567573|SUPERIORITY_OR_OTHER|||||||0.452||95.0||||p-value is for Systolic BP change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.452
71029830|NCT00406848|141567573|SUPERIORITY_OR_OTHER|||||||0.193||95.0||||p-value is for Diastolic BP change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.193
71029831|NCT00406848|141567574|SUPERIORITY_OR_OTHER|||||||0.121||95.0||||p-value is for change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.121
71029832|NCT00406848|141567574|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||p-value is for change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.038
71029833|NCT00406848|141567575|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||p-value is for Weight change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.003
71029834|NCT00406848|141567575|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||p-value is for Weight change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.127
71029835|NCT00406848|141567576|SUPERIORITY_OR_OTHER|||||||0.135||95.0||||p-value is for Diastolic Blood Pressure.|Fisher Exact|||||||0.135
71029836|NCT00406848|141567576|SUPERIORITY_OR_OTHER|||||||1||95.0||||p-value is for Pulse.|Fisher Exact|||Pulse||||1.00
71029837|NCT00406848|141567576|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||p-value is for Systolic Blood Pressure|Fisher Exact|||||||0.107
71029838|NCT00406848|141567576|SUPERIORITY_OR_OTHER|||||||0.235||95.0||||p-value is for Weight Change (gain)|Fisher Exact|||||||0.235
71152298|NCT01229267|141796658|OTHER||Vaccine Efficacy|0.695|||||TWO_SIDED|95.0|0.49|0.818|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age), and intended duration of antiviral prophylaxis (≤3 versus 3 to 6 months after auto-HCT).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 consistency lot group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI is \>0.25.||0.818|0.490|
71029839|NCT00406848|141567576|SUPERIORITY_OR_OTHER|||||||0.813||95.0||||p-value is for Weight Change (loss)|Fisher Exact|||||||0.813
71029840|NCT00406848|141567577|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||p-value is for Sustained Hypertension|Fisher Exact|||||||0.668
71029841|NCT00406848|141567577|SUPERIORITY_OR_OTHER|||||||0.201||95.0||||p-value is for Orthostatic Hypotension|Fisher Exact|||||||0.201
71029842|NCT00406848|141567579|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||p-value is for Platelet Count change from baseline (Week 1) to Week 13.|ANOVA|Model: Change=Treatment+Pooled Investigator||||||0.003
71029843|NCT00406848|141567579|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Platelet Count change from baseline (Week 1) to Week 25.|ANOVA|Model: Change=Treatment+Pooled Investigator||||||<0.001
71029844|NCT00406848|141567580|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Uric Acid change from baseline (Week 1) to Week 13.|ANOVA|Model: Change = Treatment + Pooled Investigator||||||<0.001
71029845|NCT00406848|141567580|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Uric Acid change from baseline (Week 1) to Week 25.|ANOVA|Model: Change = Treatment + Pooled Investigator||||||<0.001
71029846|NCT00406848|141567581|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||p-value is for Erythrocyte Count change from baseline (Week 1) to Week 25.|ANOVA|Model: Change=Treatment+Pooled Investigator||||||0.014
71029847|NCT00406848|141567582|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||p-value is for Hemoglobin change from baseline (Week 1) to Week 25.|ANOVA|Model: Change = Treatment + Pooled Investigator||||||0.019
71029848|NCT00406848|141567582|SUPERIORITY_OR_OTHER|||||||0.048||95.0||||p-value is for Mean Cell Hemoglobin Concentration change from baseline (Week 1) to Week 25.|ANOVA|Model: Change=Treatment+Pooled Investigator||||||0.048
71029849|NCT00406848|141567583|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||p-value is for Chloride change from baseline (Week 1) to Week 25.|ANOVA|Model: Change = Treatment + Pooled Investigator||||||0.040
71029850|NCT00406848|141567583|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||p-value is for Fasting Glucose change from baseline (Week 1) to Week 25.|ANOVA|Model: Change=Treatment+Pooled Investigator||||||0.036
71029851|NCT00406848|141567584|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||Fisher Exact|||||||0.019
71029852|NCT00406848|141567585|SUPERIORITY_OR_OTHER|||||||0.815||95.0||||p-value is for QT Interval change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.815
71029853|NCT00406848|141567585|SUPERIORITY_OR_OTHER|||||||0.721||95.0||||p-value is for QTcF Interval change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.721
71029854|NCT00406848|141567585|SUPERIORITY_OR_OTHER|||||||0.376||95.0||||p-value is for QTcB Interval change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.376
71029855|NCT00406848|141567585|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||p-value is for PR Interval change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.065
71029856|NCT00406848|141567585|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||p-value is for QRS Interval change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.110
71029857|NCT00406848|141567586|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||p-value is for Successful Treatment Outcome defined with HAMD-17 ≤7 criteria.|Fisher Exact|||||||0.110
71029858|NCT00406848|141567586|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||p-value is for Successful Treatment Outcome defined with HAMD-17 ≤10 criteria.|Fisher Exact|||||||0.016
71029859|NCT00406848|141567587|SUPERIORITY_OR_OTHER|||||||0.511||95.0||||p-value is for Composite Cognitive Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.511
71029860|NCT00406848|141567587|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||p-value is for Composite Cognitive Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.300
71029861|NCT00406848|141567587|SUPERIORITY_OR_OTHER|||||||0.922||95.0||||p-value is for Learning Trials Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.922
71029862|NCT00406848|141567587|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||p-value is for Learning Trials Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.190
71029863|NCT00406848|141567587|SUPERIORITY_OR_OTHER|||||||0.85||95.0||||p-value is for Delayed Recall Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.850
71029864|NCT00406848|141567587|SUPERIORITY_OR_OTHER|||||||0.158||95.0||||p-value is for Delayed Recall Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.158
71029865|NCT00406848|141567587|SUPERIORITY_OR_OTHER|||||||0.099||95.0||||p-value is for SDST Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.099
71029866|NCT00406848|141567587|SUPERIORITY_OR_OTHER|||||||0.141||95.0||||p-value is for SDST Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.141
71029867|NCT00406848|141567587|SUPERIORITY_OR_OTHER|||||||0.379||95.0||||p-value is for 2DCT Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.379
71029868|NCT00406848|141567587|SUPERIORITY_OR_OTHER|||||||0.858||95.0||||p-value is for 2DCT Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.858
71029869|NCT00406848|141567587|SUPERIORITY_OR_OTHER|||||||0.591||95.0||||p-value is for Trail Making Test Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.591
71029870|NCT00406848|141567587|SUPERIORITY_OR_OTHER|||||||0.242||95.0||||p-value is for Trail Making Test Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.242
71029871|NCT02719522|141567618|SUPERIORITY|The primary safety objective was to determine if the 2-sided 95% upper confidence interval of the primary safety endpoint was below the threshold of 15%|||||<|0.001|||||||Clopper-Pearson|||The primary safety objective was to determine if the 2-sided 95% upper confidence interval of the primary safety endpoint was below the threshold of 15%. Missing safety data for subjects who were lost to FU without any evidence of a major stroke/death were imputed in the analysis using multiple imputation. Subjects who withdrew from the study prior to completion and had experienced a major stroke or death were counted towards the primary safety endpoint as having experienced the event.||||<0.001
71029872|NCT04025879|141567664|SUPERIORITY||Cox Proportional Hazard|0.58||||0.00025|TWO_SIDED|95.0|0.43|0.78|||Log Rank||Stratified by randomization stratification factors: PD-L1 Status (\>=1% vs \<1%/not evaluable/indeterminate), disease stage (II vs III), histology (squamous vs non-squamous).|||0.78|0.43|0.00025
71029873|NCT04025879|141567666|SUPERIORITY||DIFFERENCE OF PCR|20.5|||||TWO_SIDED|95.0|14.3|26.6|||||Strata adjusted difference based on Cochran-Mantel-Haenszel (CMH) method of weighting.|||26.6|14.3|
71029874|NCT04025879|141567666|SUPERIORITY||Odds Ratio (OR)|6.64|||||TWO_SIDED|95.0|3.4|12.97|||||Strata adjusted odds ratio using Mantel-Haenszel method.|||12.97|3.40|
71029875|NCT04025879|141567667|SUPERIORITY||DIFFERENCE OF MPR|23.2|||||TWO_SIDED|95.0|15.8|30.6|||||Strata adjusted difference based on Cochran-Mantel-Haenszel (CMH) method of weighting.|||30.6|15.8|
71029876|NCT04025879|141567667|SUPERIORITY||Odds Ratio (OR)|4.01||||||95.0|2.48|6.49|||||Strata adjusted odds ratio using Mantel-Haenszel method.|||6.49|2.48|
71029877|NCT00366899|141567698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-0.4||||||95.0|-2.2|1.0||||||For Pertussis PT the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated.||1.0|-2.2|
71029878|NCT00366899|141567698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-4.0|3.8||||||For Pertussis PT the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥16 EU/mL threshold was calculated.||3.8|-4.0|
71029879|NCT00366899|141567698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.6|1.4||||||For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated||1.4|-1.6|
71029880|NCT00366899|141567698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.6|1.4||||||For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥7.82 EU/mL threshold was calculated.||1.4|-1.6|
71029881|NCT00366899|141567698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-0.9||||||95.0|-5.0|2.9||||||For Pertussis FHA the difference in percentages between the two groups ( 13vPnC - 7vPnC) at ≥31 EU/mL threshold was calculated.||2.9|-5.0|
71029882|NCT00366899|141567698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.5|1.4||||||For Pertactin the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated.||1.4|-1.5|
71029883|NCT00366899|141567698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-3.2||||||95.0|-7.8|1.0||||||For Pertactin the difference in percentages between the two groups ( 13vPnC - 7vPnC) at ≥40 EU/mL threshold was calculated.||1.0|-7.8|
71029884|NCT00366899|141567698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.7||||||95.0|-3.6|5.0||||||For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥10.0 mIU/mL threshold was calculated.||5.0|-3.6|
71029885|NCT00366899|141567698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-3.2||||||95.0|-9.1|2.4||||||For Haemophilus influenzae type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 μg/mL threshold was calculated.||2.4|-9.1|
71029886|NCT00366899|141567698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.7||||||95.0|-8.2|9.5||||||For Haemophilus influenzae type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 μg/mL threshold was calculated.||9.5|-8.2|
71029887|NCT00366899|141567698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.8|1.6||||||For Diptheria the difference in percentages between the two groups ( 13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated.||1.6|-1.8|
71029888|NCT00366899|141567698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-3.5||||||95.0|-8.3|0.8||||||For Diptheria the difference in percentage between the two groups ( 13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.||0.8|-8.3|
71029889|NCT00366899|141567698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|1.7||||||95.0|-3.9|7.1||||||For Tetanus the difference in percentage between the two groups ( 13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.||7.1|-3.9|
71029890|NCT00366899|141567698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-0.1||||||95.0|-2.3|1.7||||||For Polio Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.||1.7|-2.3|
71029891|NCT00366899|141567698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-1.0||||||95.0|-5.0|2.8||||||For Polio Type 2 the difference in percentage between the two groups ( 13vPnC - 7vPnC) at ≥1:8 threshold was calculated.||2.8|-5.0|
71029892|NCT00366899|141567698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.7||||||95.0|-1.6|2.9||||||For Polio Type 3 the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.||2.9|-1.6|
71029893|NCT00366899|141567698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.6|1.7||||||For Pertussis PT the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated||1.7|-1.6|
71029894|NCT00366899|141567698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-2.7||||||95.0|-7.3|1.8||||||For Pertussis PT the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥21 EU/mL threshold was calculated.||1.8|-7.3|
71029895|NCT00366899|141567698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.6|1.7||||||For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated||1.7|-1.6|
70969085|NCT04869345|141443934|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|1.28||0.835|TWO_SIDED|95.0|-2.8|2.27||The threshold for statistical significance was 0.05.|Mixed Models Analysis|P-value adjusted using the Kenward-Roger (1997) degrees of freedom method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Intensity scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||2.27|-2.80|0.835
71029896|NCT00366899|141567698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.6|1.7||||||For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥7.82 EU/mL threshold was calculated||1.7|-1.6|
71029897|NCT00366899|141567698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-0.1||||||95.0|-4.3|4.1||||||For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥162 EU/mL threshold was calculated||4.1|-4.3|
70969086|NCT04869345|141443934|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|1.29||0.732|TWO_SIDED|95.0|-2.12|3.0||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Intensity scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||3.00|-2.12|0.732
71008427|NCT03018028|141524710|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|2.95||||0.1193|TWO_SIDED|95.0|0.76|11.46||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 3 mg / Liraglutide 0.9 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||11.46|0.76|0.1193
70969087|NCT04869345|141443934|SUPERIORITY||Mean Difference (Net)|0.71|STANDARD_ERROR_OF_MEAN|1.38||0.609|TWO_SIDED|95.0|-2.05|3.47||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Intensity scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||3.47|-2.05|0.609
70969088|NCT04869345|141443935|SUPERIORITY||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|1.08||0.445|TWO_SIDED|95.0|-2.97|1.31||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Interference scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||1.31|-2.97|0.445
70969089|NCT04869345|141443935|SUPERIORITY||Mean Difference (Final Values)|1.38|STANDARD_ERROR_OF_MEAN|1.09||0.209|TWO_SIDED|95.0|-0.78|3.54||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Interference scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||3.54|-0.78|0.209
70969090|NCT04869345|141443935|SUPERIORITY||Mean Difference (Net)|2.21|STANDARD_ERROR_OF_MEAN|1.17||0.063|TWO_SIDED|95.0|-0.12|4.54||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Interference scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||4.54|-0.12|0.063
70969091|NCT04869345|141443936|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.95||0.792|TWO_SIDED|95.0|-1.63|2.13||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Physical Functioning scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||2.13|-1.63|0.792
70969092|NCT04869345|141443936|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|0.95||0.209|TWO_SIDED|95.0|-0.69|3.09||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Physical Functioning scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||3.09|-0.69|0.209
71008704|NCT02055976|141525244|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.56|STANDARD_ERROR_OF_MEAN|2.927|<|0.001|TWO_SIDED|95.0|3.743|15.377|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||15.377|3.743|<0.001
71029898|NCT00366899|141567698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.6|1.7||||||For Pertactin the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated.||1.7|-1.6|
71029899|NCT00366899|141567698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-0.5||||||95.0|-4.7|3.7||||||For Pertactin the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥106 EU/mL threshold was calculated.||3.7|-4.7|
71029900|NCT00366899|141567698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-0.4||||||95.0|-3.0|2.0||||||For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥10.0 mIU/mL threshold was calculated.||2.0|-3.0|
70969093|NCT04869345|141443936|SUPERIORITY||Mean Difference (Net)|0.95|STANDARD_ERROR_OF_MEAN|0.66||0.151|TWO_SIDED|95.0|-0.35|2.26||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Intensity scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||2.26|-0.35|0.151
70969094|NCT04869345|141443937|SUPERIORITY||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|1.47||0.601|TWO_SIDED|95.0|-2.14|3.69||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Fatigue scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||3.69|-2.14|0.601
70969095|NCT04869345|141443937|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|1.49||0.269|TWO_SIDED|95.0|-4.6|1.29||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Fatigue scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||1.29|-4.60|0.269
71029901|NCT00366899|141567698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|1.4||||||95.0|-0.8|4.2||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 μg/mL threshold was calculated||4.2|-0.8|
71029902|NCT00366899|141567698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|4.0||||||95.0|-0.4|8.7||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 μg/mL threshold was calculated.||8.7|-0.4|
71029903|NCT00366899|141567698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-2.3|2.0||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated.||2.0|-2.3|
71029904|NCT00366899|141567698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-2.3|2.0||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated||2.0|-2.3|
71029905|NCT00366899|141567698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|3.8||||||95.0|-1.7|10.9||||||For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.||10.9|-1.7|
71029906|NCT00366899|141567698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-2.4|2.1||||||For Polio Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.||2.1|-2.4|
71029907|NCT00366899|141567698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-2.4|2.1||||||For Polio Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.||2.1|-2.4|
71029908|NCT00366899|141567698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-2.4|2.1||||||For Polio Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.||2.1|-2.4|
71029909|NCT00366899|141567699|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.98||||||95.0|0.87|1.1||||||For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated||1.10|0.87|
71029910|NCT00366899|141567699|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.03||||||95.0|0.92|1.16||||||For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated||1.16|0.92|
71029911|NCT00366899|141567699|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.01||||||95.0|0.87|1.17||||||For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated||1.17|0.87|
71029912|NCT00366899|141567699|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.01||||||95.0|0.89|1.15||||||For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated||1.15|0.89|
71029913|NCT00366899|141567699|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.94||||||95.0|0.83|1.07||||||For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated||1.07|0.83|
71029914|NCT00366899|141567699|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.94||||||95.0|0.82|1.07||||||For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated||1.07|0.82|
71029915|NCT00366899|141567702|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the geometric mean concentration (GMC)/geometric mean titer (GMT) ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.96||||||95.0|0.72|1.27||||||For Hepatitis b the geometric mean concentration (GMC) ratio (13vPnC/7vPnC) was calculated||1.27|0.72|
71029916|NCT00366899|141567702|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.72||||||95.0|0.54|0.96||||||For Hepatitis b the GMC ratio (13vPnC/7vPnC) was calculated||0.96|0.54|
71029917|NCT00366899|141567703|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.99||||||95.0|0.75|1.3||||||or Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated||1.30|0.75|
71029918|NCT00366899|141567703|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.03||||||95.0|0.81|1.3||||||For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated||1.30|0.81|
71029919|NCT00366899|141567704|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.78||||||95.0|0.65|0.94||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||0.94|0.65|
71029920|NCT00366899|141567704|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.85||||||95.0|0.67|1.08||||||For Tetanus the GMC ratio (13vPnC/7vPnC) was calculated||1.08|0.67|
71029921|NCT00366899|141567704|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.75||||||95.0|0.63|0.89||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||0.89|0.63|
71029922|NCT00366899|141567704|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.25||||||95.0|0.88|1.79||||||For Tetanus the GMC ratio (13vPnC/7vPnC) was calculated||1.79|0.88|
71029923|NCT00366899|141567705|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.87||||||95.0|0.7|1.08||||||For Polio Type 1 the GMC ratio (13vPnC/7vPnC) was calculated||1.08|0.70|
71029924|NCT00366899|141567705|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.95||||||95.0|0.74|1.22||||||For Polio Type 2 the GMC ratio (13vPnC/7vPnC) was calculated||1.22|0.74|
71029925|NCT00366899|141567705|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.88||||||95.0|0.68|1.13||||||For Polio Type 3 the GMC ratio (13vPnC/7vPnC) was calculated||1.13|0.68|
71029926|NCT00366899|141567705|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.69||||||95.0|0.55|0.86||||||For Polio Type 1 the GMC ratio (13vPnC/7vPnC) was calculated||0.86|0.55|
71029927|NCT00366899|141567705|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.85||||||95.0|0.68|1.07||||||For Polio Type 2 the GMC ratio (13vPnC/7vPnC) was calculated||1.07|0.68|
71029928|NCT00366899|141567705|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.65||||||95.0|0.51|0.83||||||For Polio Type 3 the GMC ratio (13vPnC/7vPnC) was calculated||0.83|0.51|
71152299|NCT01229267|141796659|OTHER||Vaccine Efficacy|0.735|||||TWO_SIDED|95.0|0.498|0.86|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age), and intended duration of antiviral prophylaxis (≤3 versus 3 to 6 months after auto-HCT).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 consistency lot group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI is \>0.25.||0.860|0.498|
71029929|NCT02848326|141567717|SUPERIORITY||Least squares mean difference|-1.15|STANDARD_ERROR_OF_MEAN|0.4||0.0039|TWO_SIDED|95.0|-1.93|-0.37||Mixed-effects model for repeated measures (MMRM) model included baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.37|-1.93|0.0039
71029930|NCT02848326|141567717|SUPERIORITY||Least squares mean difference|-0.91|STANDARD_ERROR_OF_MEAN|0.33||0.0056|TWO_SIDED|95.0|-1.55|-0.27||MMRM model included baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.27|-1.55|0.0056
71029931|NCT02848326|141567717|SUPERIORITY||Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.33||0.0325|TWO_SIDED|95.0|-1.35|-0.06||MMRM model included baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.06|-1.35|0.0325
71029932|NCT02848326|141567717|SUPERIORITY||Least squares mean difference|-1.39|STANDARD_ERROR_OF_MEAN|0.42||0.001|TWO_SIDED|95.0|-2.21|-0.56||MMRM model included baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.56|-2.21|0.0010
71029933|NCT02848326|141567717|SUPERIORITY||Least squares mean difference|-1.29|STANDARD_ERROR_OF_MEAN|0.41||0.0016|TWO_SIDED|95.0|-2.09|-0.49||MMRM model included baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.49|-2.09|0.0016
71029934|NCT02848326|141567718|SUPERIORITY||Least squares mean difference|-1.38|STANDARD_ERROR_OF_MEAN|0.43||0.0014|TWO_SIDED|95.0|-2.23|-0.54||MMRM model included baseline monthly headache days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.54|-2.23|0.0014
71029935|NCT02848326|141567718|SUPERIORITY||Least squares mean difference|-1.24|STANDARD_ERROR_OF_MEAN|0.36||0.0005|TWO_SIDED|95.0|-1.94|-0.55||MMRM model included baseline monthly headache days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.55|-1.94|0.0005
71029936|NCT02848326|141567718|SUPERIORITY||Least squares mean difference|-0.94|STANDARD_ERROR_OF_MEAN|0.36||0.0087|TWO_SIDED|95.0|-1.64|-0.24||MMRM model included baseline monthly headache days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.24|-1.64|0.0087
71029937|NCT02848326|141567718|SUPERIORITY||Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.46||0.0044|TWO_SIDED|95.0|-2.2|-0.41||MMRM model included baseline monthly headache days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.41|-2.20|0.0044
71029938|NCT02848326|141567718|SUPERIORITY||Least squares mean difference|-1.39|STANDARD_ERROR_OF_MEAN|0.44||0.0017|TWO_SIDED|95.0|-2.26|-0.53||MMRM model included baseline monthly headache days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.53|-2.26|0.0017
71029939|NCT02848326|141567719|SUPERIORITY||Odds Ratio (OR)|1.5||||0.0617|TWO_SIDED|95.0|0.98|2.31||Generalized linear mixed model (GLMM) for repeated measures with fixed factors(treatment group,visit), covariates(baseline migraine days), interactions(treatment group;baseline migraine days by visit) with an unstructured covariance matrix.|GLMM for repeated measures|||||2.31|0.98|0.0617
71029940|NCT02848326|141567719|SUPERIORITY||Odds Ratio (OR)|1.46||||0.0369|TWO_SIDED|95.0|1.02|2.08||GLMM for repeated measures with fixed factors (treatment group, visit), covariates (baseline migraine days), interactions (treatment group by visit; baseline migraine days by visit) with an unstructured covariance matrix.|GLMM for repeated measures|||||2.08|1.02|0.0369
71029941|NCT02848326|141567719|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0512|TWO_SIDED|95.0|1.0|2.03||GLMM for repeated measures with fixed factors (treatment group, visit), covariates (baseline migraine days), interactions (treatment group by visit; baseline migraine days by visit) with an unstructured covariance matrix.|GLMM for repeated measures|||||2.03|1.00|0.0512
71029942|NCT02848326|141567719|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0113|TWO_SIDED|95.0|1.15|2.91||GLMM for repeated measures with fixed factors (treatment group, visit), covariates (baseline migraine days), interactions (treatment group by visit; baseline migraine days by visit) with an unstructured covariance matrix.|GLMM for repeated measures|||||2.91|1.15|0.0113
71029943|NCT02848326|141567719|SUPERIORITY||Odds Ratio (OR)|2.03||||0.0019|TWO_SIDED|95.0|1.3|3.18||GLMM for repeated measures with fixed factors (treatment group, visit), covariates (baseline migraine days), interactions (treatment group by visit; baseline migraine days by visit) with an unstructured covariance matrix.|GLMM for repeated measure|||||3.18|1.30|0.0019
71029944|NCT02848326|141567720|SUPERIORITY||Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.35||0.0002|TWO_SIDED|95.0|-1.99|-0.6||MMRM model included baseline monthly acute medication use days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.60|-1.99|0.0002
71152300|NCT01229267|141796660|OTHER||Vaccine Efficacy|0.837|||||TWO_SIDED|95.0|0.446|0.952|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age), and intended duration of antiviral prophylaxis (≤3 versus 3 to 6 months after auto-HCT).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 consistency lot group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI is \>0.25.||0.952|0.446|
71029945|NCT02848326|141567720|SUPERIORITY||Least squares mean difference|-1.44|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|-2.01|-0.87||MMRM model included baseline monthly acute medication use days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.87|-2.01|<0.0001
71029946|NCT02848326|141567720|SUPERIORITY||Least squares mean difference|-1.11|STANDARD_ERROR_OF_MEAN|0.29||0.0001|TWO_SIDED|95.0|-1.68|-0.54||MMRM model included baseline monthly acute medication use days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.54|-1.68|0.0001
71029947|NCT02848326|141567720|SUPERIORITY||Least squares mean difference|-1.35|STANDARD_ERROR_OF_MEAN|0.37||0.0003|TWO_SIDED|95.0|-2.08|-0.62||MMRM model included baseline monthly acute medication use days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.62|-2.08|0.0003
71029948|NCT02848326|141567720|SUPERIORITY||Least squares mean difference|-1.22|STANDARD_ERROR_OF_MEAN|0.36||0.0007|TWO_SIDED|95.0|-1.93|-0.52||MMRM model included baseline monthly acute medication use days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.52|-1.93|0.0007
71029949|NCT04526210|141567730|OTHER||Geometric least square (LS) mean ratio|0.98|||||TWO_SIDED|90.0|0.9415|1.0205||||||||1.0205|0.9415|
71029950|NCT04526210|141567731|OTHER||Geometric LS mean ratio|0.978|||||TWO_SIDED|90.0|0.9344|1.0244||||||||1.0244|0.9344|
71029951|NCT04526210|141567732|OTHER||Geometric LS mean ratio|0.981|||||TWO_SIDED|90.0|0.9368|1.0269||||||||1.0269|0.9368|
71029952|NCT02999178|141567742|SUPERIORITY||Adjusted mean difference|106.96|STANDARD_ERROR_OF_MEAN|21.15|<|0.0001|TWO_SIDED|95.0|65.42|148.5||Treatment comparison of slopes was assessed through the treatment-by-time interaction coefficient. P-value was not adjusted for multiple comparisons.|Mixed Models Analysis|"Fixed effects: Treatment, HRCT fibrotic pattern, baseline FVC (mL), treatment-by-time, baseline-by-time interactions.~Random effects: time, intercept."|Difference of adjusted annual rates of decline was calculated as Nintedanib - Placebo.|The decrease in FVC was assumed to be linear within each participant over 52 weeks. The intercepts and slopes were assumed to be normally distributed with unstructured covariance matrix. The within participant error was assumed to be independent and normally distributed with mean 0 and a common variance. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors (SEs).||148.50|65.42|<.0001
71029953|NCT02999178|141567743|SUPERIORITY||Adjusted mean difference|128.2|STANDARD_ERROR_OF_MEAN|29.17|<|0.0001|TWO_SIDED|95.0|70.81|185.59||Treatment comparison of slopes was assessed through the treatment-by-time interaction coefficient. P-value was not adjusted for multiple comparisons.|Mixed Models Analysis|Fixed effects: Treatment, baseline FVC (mL), treatment-by-time, baseline-by-time interactions. Random effects: time, intercept.|Difference of adjusted annual rates of decline was calculated as Nintedanib - Placebo.|The decrease in FVC was assumed to be linear within each participant over 52 weeks. The intercepts and slopes were assumed to be normally distributed with unstructured covariance matrix. The within participant error was assumed to be independent and normally distributed with mean 0 and a common variance. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors (SEs).||185.59|70.81|<.0001
71029954|NCT02999178|141567744|OTHER|No formal hypotheses were tested.|Adjusted mean difference|1.34|STANDARD_ERROR_OF_MEAN|0.84||0.1115|TWO_SIDED|95.0|-0.31|2.98|||Mixed Model Repeated Measures (MMRM)|Fixed effects: baseline K-BILD Total score, visit, treatment-by-visit and baseline-by-visit interactions, random effect: participant.|Adjusted mean difference was calculated as Nintedanib - Placebo.|||2.98|-0.31|0.1115
71029955|NCT02999178|141567745|OTHER|No formal hypotheses were tested.|Adjusted mean difference|1.53|STANDARD_ERROR_OF_MEAN|1.12||0.1747|TWO_SIDED|95.0|-0.68|3.74|||Mixed Model Repeated Measures (MMRM)|Fixed effects: baseline K-BILD Total score, visit, treatment-by-visit and baseline-by-visit interactions, random effect: participant.|Adjusted mean difference was calculated as Nintedanib - Placebo.|||3.74|-0.68|0.1747
71029956|NCT02999178|141567746|OTHER|No formal hypotheses were tested.|Hazard Ratio (HR)|0.8||||0.3948|TWO_SIDED|95.0|0.48|1.34|||Log Rank|Stratified by HRCT fibrotic pattern.|A Cox proportional hazards model, stratified by HRCT fibrotic pattern, was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.|||1.34|0.48|0.3948
71029957|NCT02999178|141567747|OTHER|No formal hypotheses were tested.|Hazard Ratio (HR)|0.67||||0.1985|TWO_SIDED|95.0|0.36|1.24|||Log Rank||A Cox proportional hazards model was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.|||1.24|0.36|0.1985
71029958|NCT02999178|141567748|OTHER|No formal hypotheses were tested.|Hazard Ratio (HR)|0.94||||0.8544|TWO_SIDED|95.0|0.47|1.86|||Log Rank|Stratified by HRCT fibrotic pattern.|A Cox proportional hazards model, stratified by HRCT fibrotic pattern, was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.|||1.86|0.47|0.8544
71029959|NCT02999178|141567749|OTHER|No formal hypotheses were tested.|Hazard Ratio (HR)|0.68||||0.3291|TWO_SIDED|95.0|0.32|1.47|||Log Rank||A Cox proportional hazards model was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.|||1.47|0.32|0.3291
71029960|NCT02999178|141567752|OTHER|No formal hypotheses were tested.|Hazard Ratio (HR)|0.65||||0.0017|TWO_SIDED|95.0|0.49|0.85|||Log Rank|Stratified by HRCT fibrotic pattern.|A Cox proportional hazards model, stratified by HRCT fibrotic pattern, was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.|||0.85|0.49|0.0017
71029961|NCT02999178|141567753|OTHER|No formal hypotheses were tested.|Hazard Ratio (HR)|0.64||||0.0081|TWO_SIDED|95.0|0.45|0.89|||Log Rank||A Cox proportional hazards model was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.|||0.89|0.45|0.0081
71029962|NCT02999178|141567754|OTHER|No formal hypotheses were tested.|Adjusted Odds Ratio|0.7|||||TWO_SIDED|95.0|0.52|0.96|||Regression, Logistic|Logistic regression model with continuous covariate baseline FVC % pred and binary covariate HRCT fibrotic pattern.|Ratio calculated as Nintedanib divided by Placebo.|||0.96|0.52|
71029963|NCT02999178|141567755|OTHER|No formal hypotheses were tested.|Adjusted Odds Ratio|0.63|||||TWO_SIDED|95.0|0.43|0.94|||Regression, Logistic|Logistic regression model with continuous covariate baseline FVC % pred.|Ratio calculated as Nintedanib divided by Placebo.|||0.94|0.43|
71029964|NCT02999178|141567756|OTHER|No formal hypotheses were tested.|Adjusted Odds Ratio|0.5|||||TWO_SIDED|95.0|0.36|0.68|||Regression, Logistic|Logistic regression model with continuous covariate baseline FVC % pred and binary covariate HRCT fibrotic pattern.|Ratio calculated as Nintedanib divided by Placebo.|||0.68|0.36|
71029965|NCT02999178|141567757|OTHER|No formal hypotheses were tested.|Adjusted Odds Ratio|0.46|||||TWO_SIDED|95.0|0.31|0.69|||Regression, Logistic|Logistic regression model with continuous covariate baseline FVC % pred.|Ratio calculated as Nintedanib divided by Placebo.|||0.69|0.31|
71029966|NCT02999178|141567758|OTHER|No formal hypotheses were tested.|Adjusted mean difference|-3.53|STANDARD_ERROR_OF_MEAN|1.33|||TWO_SIDED|95.0|-6.14|-0.92|||Mixed Model Repeated Measures|Fixed effects: baseline, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline-by-visit interaction, random effect: participant.|Adjusted mean difference was calculated as Nintedanib - Placebo.|||-0.92|-6.14|
71029967|NCT02999178|141567759|OTHER|No formal hypotheses were tested.|Adjusted mean difference|-4.18|STANDARD_ERROR_OF_MEAN|1.68|||TWO_SIDED|95.0|-7.48|-0.88|||Mixed Model Repeated Measures|Fixed effects: baseline, visit, treatment-by-visit interaction, baseline-by-visit interaction, random effect: participant.|Adjusted mean difference was calculated as Nintedanib - Placebo.|||-0.88|-7.48|
71029968|NCT02999178|141567760|OTHER|No formal hypotheses were tested.|Adjusted mean difference|-6.09|STANDARD_ERROR_OF_MEAN|1.81|||TWO_SIDED|95.0|-9.65|-2.53|||Mixed Model Repeated Measures|Fixed effects: baseline, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline-by-visit interaction, random effect: participant.|Adjusted mean difference was calculated as Nintedanib - Placebo.|||-2.53|-9.65|
71029969|NCT02999178|141567761|OTHER|No formal hypotheses were tested.|Adjusted mean difference|-7.28|STANDARD_ERROR_OF_MEAN|2.33|||TWO_SIDED|95.0|-11.86|-2.71|||Mixed Model Repeated Measures|Fixed effects: baseline, visit, treatment-by-visit interaction, baseline-by-visit interaction, random effect: participant.|Adjusted mean difference was calculated as Nintedanib - Placebo.|||-2.71|-11.86|
71029970|NCT02086188|141567787|SUPERIORITY|||||||0.1911|||||||ANCOVA|||||||0.1911
71029971|NCT02086188|141567788|SUPERIORITY|||||||0.4271|||||||ANCOVA|||||||0.4271
71029972|NCT02086188|141567789|SUPERIORITY|||||||0.1723|||||||ANCOVA|||||||0.1723
71029973|NCT02086188|141567790|SUPERIORITY|||||||0.634|||||||ANCOVA|||||||0.6340
71029974|NCT02086188|141567791|SUPERIORITY|||||||0.0091|||||||ANCOVA|||||||0.0091
71029975|NCT03471078|141567797|OTHER|The primary efficacy endpoint was tested between avatrombopag and placebo using the Cochran-Mantel-Haenszel 2-sided test at α=0.05, adjusting for the number of eligible chemotherapy agents as collected in IWRS (1 or ≥2 permissible chemotherapy agents).|Mean Difference (Final Values)|-3.0||||0.7186|TWO_SIDED|95.0|-21.7|15.6|||Cochran-Mantel-Haenszel|||||15.6|-21.7|0.7186
71029976|NCT03471078|141567798|OTHER|||||||0.8372|||||||Van Elteren Test|||||||0.8372
71029977|NCT00153803|141567816|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.165|TWO_SIDED|95.0|0.65|1.33|||Log Rank|||||1.33|0.65|0.165
71029978|NCT00153803|141567817|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.32|TWO_SIDED|95.0|0.85|1.63|||Log Rank|||||1.63|0.85|0.32
71029979|NCT03292653|141567825|SUPERIORITY||Difference in Least Squares (LS) Means|1.26|STANDARD_ERROR_OF_MEAN|3.64||0.736|TWO_SIDED|90.0|-5.4|7.93|||ANCOVA|||Analysis of Covariance (ANCOVA) model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic, ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||7.93|-5.4|0.736
71029980|NCT03292653|141567825|SUPERIORITY||Difference in LS Means|-1.02|STANDARD_ERROR_OF_MEAN|3.38||0.7694|TWO_SIDED|90.0|-7.22|5.18|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic, ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||5.18|-7.22|0.7694
71029981|NCT03292653|141567826|SUPERIORITY||Difference in LS Means|-0.04|STANDARD_ERROR_OF_MEAN|0.03||0.184|TWO_SIDED|90.0|-0.09|0.01|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||0.01|-0.09|0.184
71029982|NCT03292653|141567826|SUPERIORITY||Difference in LS Means|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3397|TWO_SIDED|90.0|-0.07|0.02|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||0.02|-0.07|0.3397
71029983|NCT03292653|141567827|SUPERIORITY||Difference in LS Means|-17.07|STANDARD_ERROR_OF_MEAN|9.12||0.094|TWO_SIDED|90.0|-33.79|-0.35|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||-0.35|-33.79|0.094
71029984|NCT03292653|141567827|SUPERIORITY||Difference in LS Means|-12.09|STANDARD_ERROR_OF_MEAN|8.49||0.1878|TWO_SIDED|90.0|-27.65|3.46|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||3.46|-27.65|0.1878
71029985|NCT03292653|141567828|SUPERIORITY||Difference in LS Means|-4.82|STANDARD_ERROR_OF_MEAN|5.8||0.4269|TWO_SIDED|90.0|-15.45|5.8|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||5.8|-15.45|0.4269
71029986|NCT03292653|141567828|SUPERIORITY||Difference in LS Means|-6.36|STANDARD_ERROR_OF_MEAN|5.39||0.2684|TWO_SIDED|90.0|-16.24|3.52|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||3.52|-16.24|0.2684
71029987|NCT03292653|141567829|SUPERIORITY||Difference in LS Means|847.2|STANDARD_ERROR_OF_MEAN|576.98||0.1761|TWO_SIDED|90.0|-210.46|1904.86|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||1904.86|-210.46|0.1761
71029988|NCT03292653|141567829|SUPERIORITY||Difference in LS Means|489.33|STANDARD_ERROR_OF_MEAN|579.35||0.4202|TWO_SIDED|90.0|-572.68|1551.34|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||1551.34|-572.68|0.4202
71029989|NCT03292653|141567830|SUPERIORITY||Difference in LS Means|13.75|STANDARD_ERROR_OF_MEAN|8.53||0.1242|TWO_SIDED|90.0|-1.03|28.53|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline erythropoietin as the covariate.||28.53|-1.03|0.1242
71029990|NCT03292653|141567830|SUPERIORITY||Difference in LS Means|0.1|STANDARD_ERROR_OF_MEAN|7.73||0.9903|TWO_SIDED|90.0|-13.49|13.3|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline erythropoietin as the covariate.||13.30|-13.49|0.9903
71029991|NCT03292653|141567831|SUPERIORITY||Difference in LS Means|-150.89|STANDARD_ERROR_OF_MEAN|116.09||0.2121|TWO_SIDED|90.0|-353.57|51.78|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline NT-proBNP as the covariate.||51.78|-353.57|0.2121
71029992|NCT03292653|141567831|SUPERIORITY||Difference in LS Means|-5.26|STANDARD_ERROR_OF_MEAN|96.88||0.9574|TWO_SIDED|90.0|-174.4|163.87|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline NT-proBNP as the covariate.||163.87|-174.4|0.9574
71029993|NCT05628675|141567837|OTHER||Effect size (Hedge's g)|0.32|||||TWO_SIDED|95.0|-0.33|0.96||||||Effect size calculation from Time 1 to Time 2 on MAAS||0.96|-0.33|
71029994|NCT05628675|141567837|OTHER||Effect size (Hedge's g)|0.72|||||TWO_SIDED|95.0|0.02|1.42||||||Effect size calculation from Time 1 to Time 3 on MAAS||1.42|0.02|
71029995|NCT05628675|141567838|OTHER||Effect size (Hedge's g)|0.36|||||TWO_SIDED|95.0|-0.29|1.01||||||Effect size calculation from Time 1 to Time 2 on P-PRFQ||1.01|-0.29|
71029996|NCT05628675|141567838|OTHER||Effect size (Hedge's g)|0.49|||||TWO_SIDED|95.0|-0.2|1.17||||||Effect size calculation from Time 1 to Time 3 on P-PRFQ||1.17|-0.20|
71029997|NCT05628675|141567839|OTHER||Effect size (Hedge's g)|1.48|||||TWO_SIDED|95.0|0.75|2.21||||||Effect size calculation from Time 1 to Time 2 on EPDS||2.21|0.75|
71029998|NCT05628675|141567839|OTHER||Effect size (Hedge's g)|2.08|||||TWO_SIDED|95.0|1.28|2.88||||||Effect size calculation from Time 1 to Time 3 on EPDS||2.88|1.28|
71029999|NCT05818137|141567841|OTHER||Change from baseline estimate|-99.2|||||TWO_SIDED|95.0|-129.6|-68.4|||||The change from baseline estimate and associated 95% confidence interval (CI) based on the Hodges-Lehmann method.|||-68.4|-129.6|
71030000|NCT05818137|141567844|OTHER||Change from baseline estimate|41.8|||||TWO_SIDED|95.0|27.8|55.5|||||The change from baseline estimate and associated 95% confidence interval (CI) based on the Hodges-Lehmann method.|||55.5|27.8|
71030001|NCT05818137|141567846|OTHER||Change from baseline estimate|-48.5|||||TWO_SIDED|95.0|-77.0|-24.8|||||The change from baseline estimate and associated 95% confidence interval (CI) based on the Hodges-Lehmann method.|||-24.8|-77.0|
71030002|NCT01475838|141567863|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the Stribild group was at least 12% worse than the PI+RTV+FTC/TDF group with respect to the percentage of participants maintaining HIV-1 RNA \< 50 copies/mL at Week 48. The alternative hypothesis was that the Stribild group was less than 12% worse than the PI+RTV+FTC/TDF group.|Difference in proportions|6.7||||0.025|TWO_SIDED|95.0|0.4|13.7|||Fisher Exact||The 95% confidence interval (CI) for the difference was from unconditional exact method using 2 inverted 1-sided tests with the standardized statistic using StatXact.|||13.7|0.4|0.025
71030003|NCT00048568|141567867|SUPERIORITY_OR_OTHER||Estimated Difference|28.2|||<|0.001|TWO_SIDED|95.0|19.8|36.7|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving ACR 20 response.|The study had a 99% power to detect a difference of 20% in ACR 20 between the 2 groups at the 5% level.||36.7|19.8|<0.001
71030004|NCT00048568|141567868|SUPERIORITY_OR_OTHER||Estimated Difference|24.4|||<|0.001|TWO_SIDED|95.0|15.9|32.9||Based on the hierarchical testing procedure for the co-primary measures, the study had 98% power to detect 18% difference in HAQ response rate between the two arms at the 5% level.|Chi-squared, Corrected|This model includes treatment as the main factor and baseline value as a covariate.|Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving HAQ response at Day 365.|||32.9|15.9|<0.001
71030005|NCT00048568|141567869|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Nonparametric ANCOVA|The rank of the change from baseline=dependent variable, treatment=the main factor, rank of baseline value as covariate.||||||0.029
71030006|NCT00048568|141567873|SUPERIORITY_OR_OTHER||Estimated Difference|33.4|||<|0.001|TWO_SIDED|95.0|25.1|41.7|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving ACR 20 response at Day 365.|||41.7|25.1|<0.001
71030007|NCT00048568|141567875|SUPERIORITY_OR_OTHER||Estimated Difference|23.0|||<|0.001|TWO_SIDED|95.0|15.0|31.1|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving ACR 50 response at Day 169.|||31.1|15.0|<0.001
71030008|NCT00048568|141567876|SUPERIORITY_OR_OTHER||Estimated Difference|30.1|||<|0.001|TWO_SIDED|95.0|21.8|38.5|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving ACR 50 response at Day 365.|||38.5|21.8|<0.001
71030009|NCT00048568|141567878|SUPERIORITY_OR_OTHER||Estimated Difference|13.3|||<|0.001|TWO_SIDED|95.0|7.0|19.5|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA + MTX and MTX + PLA in the proportion of participants achieving ACR 70 response at Day 169.|||19.5|7.0|<0.001
71030010|NCT00048568|141567879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.7|||<|0.001|TWO_SIDED|95.0|15.6|29.8|||Chi-squared, Corrected|||||29.8|15.6|<0.001
71030011|NCT00048568|141567881|SUPERIORITY_OR_OTHER||Estimated Difference|12.3|||<|0.001|TWO_SIDED|95.0|7.3|17.2|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving MCR.|||17.2|7.3|<0.001
71030012|NCT00048568|141567882|SUPERIORITY_OR_OTHER||Estimated Difference on Day 169|-1.15|||<|0.001|TWO_SIDED|95.0|-1.38|-0.91|||ANCOVA||Estimated difference between ABA + MTX and MTX + PLA on Day 169.|||-0.91|-1.38|<0.001
71030013|NCT00048568|141567882|SUPERIORITY_OR_OTHER||Estimated Difference on Day 365|-1.39|||<|0.001|TWO_SIDED|95.0|-1.63|-1.16|||ANCOVA||Estimated difference between ABA + MTX and MTX + PLA on Day 365.|||-1.16|-1.63|<0.001
71030014|NCT00048568|141567886|SUPERIORITY_OR_OTHER||Adjusted Mean Difference at Day 169|4.06|||<|0.001|TWO_SIDED|95.0|2.64|5.57|||ANCOVA|||Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.||5.57|2.64|<0.001
71030015|NCT00048568|141567886|SUPERIORITY_OR_OTHER||Adjusted Mean Difference at Day 365|4.15|||<|0.001|TWO_SIDED|95.0|2.69|5.62|||ANCOVA|||Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.||5.62|2.69|<0.001
71030016|NCT00048568|141567887|SUPERIORITY_OR_OTHER||Estimated Difference|5.7||||0.002|TWO_SIDED|95.0|2.4|9.0|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving extended MCR.|||9.0|2.4|0.002
71102627|NCT04875533|141713840|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.74|||||TWO_SIDED|95.0|0.63|0.86||||||Serotype 19A: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.86|0.63|
71152301|NCT01229267|141796661|OTHER||Risk Difference (RD)|0.2||||0.942|TWO_SIDED|95.0|-5.1|5.5|||Normal approximation||Miettinen \& Nurminen|||5.5|-5.1|0.942
71152302|NCT01864603|141796681|OTHER||Risk Ratio (RR)|0.95|||||TWO_SIDED|95.0|0.77|1.17||||||Comparison of Phase 1 arms||1.17|0.77|
71030017|NCT03831048|141568013|NON_INFERIORITY|The primary analysis of this endpoint will be performed using a linear probability model, with the following terms in the model: (1) treatment; and (2) the known donor and recipient risk factors listed above. Variables that make the model fail to converge will be dropped from the model. The test will be conducted at the one-sided 0.05 level of significance.|Mean Difference (Final Values)|-0.032|||<|0.0001|TWO_SIDED|90.0|-0.098|0.034||No multiple comparison adjustment.|Regression, Linear|||"The null and alternative hypotheses for the primary endpoint are as follows:~H0: pSOC - pDCD ≥ 0.20 vs. H1: pSOC - pDCD \< 0.20 where pDCD and pSOC represent the true survival proportions at the six months follow-up visit for DCD and SOC heart transplant patients, respectively."||0.034|-0.098|<0.0001
71030018|NCT03831048|141568014|OTHER|No hypothesis test.||||||||||||||||No null hypothesis test.|No statistical hypothesis testing. This endpoint will be summarized for the OCS Heart Population using counts and percentages and an exact (Clopper-Pearson) 95% confidence interval for the true percentage based on the binomial distribution. It will also be summarized for the modified OCS Heart Population, defined as the number of DCD hearts that were successfully transplanted after preservation and assessment on the OCS divided by the total number of DCD donor hearts that were instrumented on the OCS.|||
71030019|NCT03227445|141568076|SUPERIORITY||Odds Ratio (OR)|6.88|||<|0.001|TWO_SIDED|95.0|1.97|54.28|||stratified exact logistic model||Participants included in the model as fixed strata, treatment option was included in the exact statement and period included as fixed effects.||"There are three intercurrent events identified which could impact upon the estimand of interest:~* The participant could withdraw from randomised study device sequence and therefore withdraw from the study~* The participant could change their standard COPD maintenance medication device to one delivered via ELLIPTA, DISKUS or HANDIHALER; these subjects should have been withdrawn from the study according to the protocol.~* The participant could attend the visit without the device/s they were randomised to, in which case correct use cannot be assessed as described in the protocol.~Rescue Medication use and change to maintenance COPD medication which is not delivered via ELLIPTA, DISKUS or HANDIHALER are not considered intercurrent events"|54.28|1.97|<0.001
71030020|NCT03227445|141568078|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Sensitivity Analyses (Primary Estimand: Hypothetical)||||||<0.001
71030021|NCT03227445|141568083|SUPERIORITY||Odds Ratio (OR)|8.85|||<|0.001|TWO_SIDED|95.0|3.45||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Participants included in the model as fixed strata, treatment option was included in the exact statement and period included as fixed effects.||||3.45|<0.001
71030022|NCT03227445|141568084|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Sensitivity Analyses (Supplementary Estimand: Composite)||||||<0.001
71030023|NCT03227445|141568085|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Sensitivity Analyses (Primary Estimand: Hypothetical)||||||<0.001
71030024|NCT03227445|141568086|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Sensitivity Analyses (Supplementary Composite Estimand)||||||<0.001
71030025|NCT03227445|141568087|SUPERIORITY||Odds Ratio (OR)|6.06|||<|0.001|TWO_SIDED|95.0|2.08|24.55|||stratified exact logistic model||Participants included in the model as fixed strata, treatment option was included in the exact statement and period included as fixed effects.|||24.55|2.08|<0.001
71030026|NCT01880073|141568088|OTHER||Proportion|0.875|||||TWO_SIDED|95.0|0.74|1.0||||||||1.00|0.74|
71030027|NCT01880073|141568089|OTHER||Proportion|0.125|||||TWO_SIDED|95.0|0.0|0.26||||||||0.26|0.00|
71030028|NCT00755196|141568092|SUPERIORITY_OR_OTHER|||||||0.23|||||||2-sided sign test|||||||0.23
71030029|NCT01703832|141568094|SUPERIORITY_OR_OTHER|||||||0.1233||||||Threshold less than or equal to 0.05. The final analysis demonstrated reasonable doubt of the implicit normality assumption of the two sets of AUC data, thus medians presented for efficacy analysis. Need for further investigation (ex-post analyses).|ANCOVA|||The null-hypotheses of no treatment differences were tested by the two-sided t-tests from the respective ANCOVAs.||||0.1233
71030030|NCT01703832|141568095|SUPERIORITY_OR_OTHER|||||||0.5153||||||Threshold less than or equal to 0.05. The final analysis demonstrated reasonable doubt of the implicit normality assumption of the two sets of AUC data, thus medians presented for efficacy analysis. Need for further investigation (ex-post analyses).|ANCOVA|||The null-hypotheses of no treatment differences were tested by the two-sided t-tests from the respective ANCOVAs.||||0.5153
71030031|NCT00771537|141568115|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69|STANDARD_ERROR_OF_MEAN|0.17||0.05|TWO_SIDED|95.0|0.5|0.96|||Regression, Logistic||Women in the 1-sided message group accepted testing at a lower rate (79.4%) than those in the control group (87.4%).|||.96|.50|0.05
71152303|NCT01864603|141796682|OTHER||Rate ratio|0.26|||||TWO_SIDED|95.0|0.09|0.75||||||||0.75|0.09|
71152304|NCT02446899|141796698|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|16.3||||0.0013|TWO_SIDED|95.0|6.3|26.3||Nominal p-value.|Cochran-Mantel-Haenszel|||||26.3|6.3|0.0013
71030032|NCT00771537|141568115|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75|STANDARD_ERROR_OF_MEAN|0.17||0.1|TWO_SIDED|95.0|0.54|1.04|||Regression, Logistic||Women in the 2-sided trivial group were no different in their acceptance rate of HIV testing (81.3%) than women in the control group (87.4%).|||1.04|.54|.10
71030033|NCT00771537|141568115|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92|STANDARD_ERROR_OF_MEAN|0.176||0.63|TWO_SIDED|95.0|0.65|1.3|||Regression, Logistic||Women in the 2-sided major group were no different in rates of accepting HIV testing (83.9%) than women in the control group (87.4%)|||1.30|.65|.63
71030034|NCT00771537|141568116|SUPERIORITY_OR_OTHER||Marginal Means|2.49|STANDARD_ERROR_OF_MEAN|0.037|<|0.6|TWO_SIDED|95.0|2.42|2.56|||ANOVA|Degrees of freedom = (1,978)|There was no significant effect for the 1-sided message compared to the control group on Willingness to Participate in an HIV vaccine clinical trial.|One-way Analysis of Variance||2.56|2.42|<.60
71030035|NCT00771537|141568116|SUPERIORITY_OR_OTHER||Marginal Means|2.51|STANDARD_ERROR_OF_MEAN|0.036|<|0.25|TWO_SIDED|95.0|2.44|2.58|||ANOVA|degrees of freedom = (1,1028)|There was no significant effect for the 2-sided trivial message compared to the control group on Willingness to Participate in an HIV vaccine clinical trial.|One-Way Analysis of Variance||2.58|2.44|<.25
71030036|NCT00771537|141568116|SUPERIORITY_OR_OTHER||Marginal Means|2.47|STANDARD_ERROR_OF_MEAN|0.036|<|0.91|TWO_SIDED|95.0|2.4|2.54|||ANOVA||There was no significant effect for the 2-sided major message compared to the control group on Willingness to Participate in an HIV vaccine clinical trial.|One-Way Analysis of Variance||2.54|2.40|<.91
71030037|NCT00440557|141568142|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a difference in the mean change in Hb from baseline to the average of the last 8 weeks of treatment through Week 22 of -0.3 g/dL between standard-tx group (TIW) and test-tx group (QW), a pooled standard deviation of 1.7 g/dL, and a noninferiority margin of 1 g/dL, a sample size of approximately 250 participants (125 per group) will provide 90% power to demonstrate that the test treatment group is not inferior to the standard-treatment group for an overall 2-sided 0.05 significance level|Difference of Least Squares Means|-0.17|STANDARD_ERROR_OF_MEAN|0.106||||95.0|-0.38|0.037||This comparison between QW and TIW was performed prior to comparing Q2W with TIW in the statistical analysis 2 according to a planned stepdown procedure for controlling multiplicity.||||The null hypothesis is the mean change in Hb concentration from baseline to the average of the last 8 weeks of treatment (tX) through Week 22 in the QW group is not lower than that of the TIW group by more than 1 g/dL.||0.037|-0.380|
71030038|NCT00440557|141568142|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a difference in the mean change in Hb from baseline to the average of the last 8 weeks of treatment through Week 22 of -0.3 g/dL between standard-tx group (TIW) and test-tx group (QW), a pooled standard deviation of 1.7 g/dL, and a noninferiority margin of 1 g/dL, a sample size of approximately 250 participants (125 per group) will provide 90% power to demonstrate that the test treatment group is not inferior to the standard-treatment group for an overall 2-sided 0.05 significance level|Difference of Least Squares Means|-0.43|STANDARD_ERROR_OF_MEAN|0.107||||95.0|-0.641|-0.221||Since the non-inferiority was declared in the statistical analysis 1, this comparison between Q2W and TIW was then performed according to a planned stepdown procedure for controlling multiplicity.||||The null hypothesis is the mean change in Hb concentration from baseline to the average of the last 8 weeks of treatment through Week 22 in the Q2W group is not lower than that of the TIW group by more than 1 g/dL.||-0.221|-0.641|
71030039|NCT00440557|141568143|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-7.8||||||95.0|-17.2|1.7||||||||1.7|-17.2|
71030040|NCT00440557|141568143|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-15.0||||||95.0|-25.0|-5.0||||||||-5.0|-25.0|
71030041|NCT00440557|141568144|SUPERIORITY_OR_OTHER||Difference of Least Squares Means|-0.26||||||95.0|-0.564|0.043|||ANOVA|||||0.043|-0.564|
71030042|NCT00440557|141568144|SUPERIORITY_OR_OTHER||Difference of Least Squares Means|-0.45||||||95.0|-0.755|-0.147|||ANOVA|||||-0.147|-0.755|
71030043|NCT00440557|141568145|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-3.9||||||95.0|-9.5|1.6||||||||1.6|-9.5|
71152305|NCT02446899|141796699|SUPERIORITY||Mean Difference (Final Values)|17.3||||0.0022|TWO_SIDED|95.0|6.5|28.2||Adjusted p-value.|Cochran-Mantel-Haenszel|||The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).||28.2|6.5|0.0022
71152306|NCT02446899|141796700|SUPERIORITY||Mean Difference (Final Values)|21.2||||0.0135|TWO_SIDED|95.0|6.8|35.7||Adjusted p-value.|Cochran-Mantel-Haenszel|||The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).||35.7|6.8|0.0135
71030044|NCT00440557|141568145|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-5.5||||||95.0|-11.4|0.3||||||||0.3|-11.4|
71030045|NCT00440557|141568146|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-2.7||||||95.0|-14.2|8.7||||||||8.7|-14.2|
71030046|NCT00440557|141568146|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-9.9||||||95.0|-21.7|1.8||||||||1.8|-21.7|
71030047|NCT00440557|141568147|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|2.6||||||95.0|-9.6|14.8||||||||14.8|-9.6|
71030048|NCT00440557|141568147|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-3.0||||||95.0|-15.0|9.0||||||||9.0|-15.0|
71030049|NCT00440557|141568148|SUPERIORITY_OR_OTHER||Difference of Least Squares Means|0.03||||||95.0|-0.21|0.27|||ANOVA|||||0.270|-0.210|
71030050|NCT00440557|141568148|SUPERIORITY_OR_OTHER||Difference of Least Squares Means|-0.07||||||95.0|-0.315|0.166|||ANOVA|||||0.166|-0.315|
71030051|NCT00440557|141568149|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-8.8||||||95.0|-16.0|-1.9||||||||-1.9|-16|
71030052|NCT00440557|141568149|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-10.0||||||95.0|-18.0|-3.2||||||||-3.2|-18.0|
71030053|NCT01918800|141568150|SUPERIORITY_OR_OTHER|||||||0.64||||||No adjustment for multiple comparisons. A priori threshold for clinical significance was 7 point improvement.|paired t test|||||||.64
71030054|NCT01918800|141568151|SUPERIORITY_OR_OTHER|||||||0.04||||||No adjustments for multiple comparisons.|paired t test|||||||0.04
71030055|NCT01918800|141568152|SUPERIORITY_OR_OTHER|||||||0.35||||||No adjustment for multiple comparisons|Paired t test|||||||0.35
71030056|NCT01918800|141568153|SUPERIORITY|||||||0.8||||||The p value in this case is for the SF-36 Physical|Wilcoxon (Mann-Whitney)|||||||0.8
71030057|NCT01918800|141568153|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||The p value in this case refers to the SF-36 Mental||||.09
71030058|NCT01918800|141568154|SUPERIORITY_OR_OTHER|||||||0.521||||||This p value applies to the RAPA Cardiovascular|Wilcoxon (Mann-Whitney)|||||||0.521
71030059|NCT01918800|141568154|SUPERIORITY|||||||0.4199|||||||Wilcoxon (Mann-Whitney)|||This p values is for the RAPA Strength||||0.4199
71030060|NCT01918800|141568154|SUPERIORITY|||||||0.854|||||||Wilcoxon (Mann-Whitney)|||||||0.854
71030061|NCT01918800|141568155|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
71030062|NCT01918800|141568156|SUPERIORITY_OR_OTHER|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
71030063|NCT01874951|141568197|NON_INFERIORITY_OR_EQUIVALENCE|An initial power analysis at the time of protocol development suggested that with 6 patients in each treatment group, we could expect a 79% chance of achieving significance (2-sided p \< 0.05) if the true response rate to low-dose naltrexone (LDN) was 80% and the true placebo response rate was 20%.||||||0.55||||||Threshold of statistical significance is 0.05.|Chi-squared|Chi-squared value was 1.5.||Response rates were based on attaining a reduction in the HAM-D-17 scale of 50% or greater compared to baseline. We hypothesized that naltrexone would produce a significantly greater response rate than placebo.||||0.55
71030064|NCT02158936|141568210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.37||||1|TWO_SIDED|95.0|0.21|0.65||One sided p value|Cochran-Mantel-Haenszel|Stratified by Interactive Voice Response System (IVRS) stratification factors||||0.65|0.21|1.000
71030065|NCT02158936|141568211|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.42||||0.164|TWO_SIDED|95.0|0.97|2.08|||Log Rank|||Confidence Intervals estimated using the Brookmeyer-Crowley method. Hazard ratios are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower risk with eltrombopag compared with Placebo. Log-rank test stratified by IVRS stratification factors||2.08|0.97|0.164
71030066|NCT02158936|141568228|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.31|||||TWO_SIDED|90.0|0.99|1.74|||ANOVA|||||1.74|0.990|
71030067|NCT02158936|141568229|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.39|||||TWO_SIDED|90.0|0.97|1.99|||ANOVA|||||1.99|0.970|
71030068|NCT01706926|141568230|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.193|<|0.001|TWO_SIDED|95.0|-1.06|-0.31|||Repeated measures model|||Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95 percent (%) confidence interval (CI) was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.||-0.31|-1.06|<0.001
71030069|NCT01706926|141568230|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.96|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.33|-0.58|||Repeated measures model|||Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.||-0.58|-1.33|<0.001
71030070|NCT01706926|141568230|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.22|STANDARD_ERROR_OF_MEAN|0.193|<|0.001|TWO_SIDED|95.0|-1.6|-0.84|||Repeated measures model|||Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.||-0.84|-1.60|<0.001
71030071|NCT01706926|141568231|SUPERIORITY_OR_OTHER||Percent difference|25.9|||<|0.001|TWO_SIDED|95.0|11.5|40.3|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|||40.3|11.5|<0.001
71152307|NCT02446899|141796701|SUPERIORITY||Mean Difference (Final Values)|24.0||||0.0392|TWO_SIDED|95.0|4.3|43.6||Adjusted p-value.|Cochran-Mantel-Haenszel|||The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).||43.6|4.3|0.0392
71030072|NCT01706926|141568231|SUPERIORITY_OR_OTHER||Percent difference|36.5|||<|0.001|TWO_SIDED|95.0|22.5|50.5|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|||50.5|22.5|<0.001
71030073|NCT01706926|141568231|SUPERIORITY_OR_OTHER||Percent difference|48.7|||<|0.001|TWO_SIDED|95.0|35.2|62.3|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|||62.3|35.2|<0.001
71030074|NCT01706926|141568238|SUPERIORITY_OR_OTHER||Percent difference|16.0||||0.013|TWO_SIDED|95.0|3.9|28.2|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|||28.2|3.9|0.013
71030075|NCT01706926|141568238|SUPERIORITY_OR_OTHER||Percent difference|13.5||||0.03|TWO_SIDED|95.0|1.8|25.3|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|||25.3|1.8|0.030
71030076|NCT01706926|141568238|SUPERIORITY_OR_OTHER||Percent difference|28.2|||<|0.001|TWO_SIDED|95.0|15.2|41.1|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|||41.1|15.2|<0.001
71030077|NCT01706926|141568239|SUPERIORITY_OR_OTHER||Percent difference|8.6||||0.079|TWO_SIDED|95.0|0.4|16.9|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response). p-value estimated from fisher's exact test.|||16.9|0.4|0.079
71102628|NCT04875533|141713840|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.64|||||TWO_SIDED|95.0|0.53|0.76||||||Serotype 19F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.76|0.53|
71030078|NCT01706926|141568239|SUPERIORITY_OR_OTHER||Percent difference|6.9||||0.133|TWO_SIDED|95.0|-0.8|14.6|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response). p-value estimated from fisher's exact test.|||14.6|-0.8|0.133
71030079|NCT01706926|141568239|SUPERIORITY_OR_OTHER||Percent difference|10.2||||0.026|TWO_SIDED|95.0|1.5|18.9|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response). p-value estimated from fisher's exact test.|||18.9|1.5|0.026
71030080|NCT01706926|141568240|SUPERIORITY_OR_OTHER||Adjusted Mean difference|15.79|STANDARD_ERROR_OF_MEAN|6.007||0.009|TWO_SIDED|95.0|3.96|27.61|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||27.61|3.96|0.009
71030081|NCT01706926|141568240|SUPERIORITY_OR_OTHER||Adjusted mean difference|16.99|STANDARD_ERROR_OF_MEAN|5.879||0.004|TWO_SIDED|95.0|5.42|28.56|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||28.56|5.42|0.004
71030082|NCT01706926|141568240|SUPERIORITY_OR_OTHER||Adjusted mean difference|27.47|STANDARD_ERROR_OF_MEAN|5.892|<|0.001|TWO_SIDED|95.0|15.87|39.07|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||39.07|15.87|<0.001
71030083|NCT01706926|141568241|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.7|||<|0.001|TWO_SIDED|95.0|2.56|8.8|||Proportional odds analysis||Odds ratio, 95% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor. Odds ratios greater than (\>) one favored mavrilimumab.|||8.80|2.56|<0.001
71030084|NCT01706926|141568241|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.81|||<|0.001|TWO_SIDED|95.0|2.64|8.92|||Proportional odds analysis||Odds ratio, 95% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor. Odds ratios \>one favored mavrilimumab.|||8.92|2.64|<0.001
71030085|NCT01706926|141568241|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.11|||<|0.001|TWO_SIDED|95.0|3.85|13.4|||Proportional odds analysis||Odds ratio, 95% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor. Odds ratios \>one favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.||13.40|3.85|<0.001
71030086|NCT01706926|141568242|SUPERIORITY_OR_OTHER||Percent difference|16.0||||0.004|TWO_SIDED|95.0|6.0|26.1|||Fisher Exact||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of placebo or active responders was less than 5.||26.1|6.0|0.004
71030087|NCT01706926|141568242|SUPERIORITY_OR_OTHER||Percent difference|12.7||||0.014|TWO_SIDED|95.0|3.3|22.1|||Fisher Exact||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of placebo or active responders was less than 5.||22.1|3.3|0.014
71030088|NCT01706926|141568242|SUPERIORITY_OR_OTHER||Percent difference|14.0||||0.007|TWO_SIDED|95.0|4.2|23.9|||Fisher Exact||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of placebo or active responders was less than 5.||23.9|4.2|0.007
71030089|NCT01706926|141568242|SUPERIORITY_OR_OTHER||Percent difference|24.7|||<|0.001|TWO_SIDED|95.0|12.7|36.6|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|The analysis reported DAS28 (CRP) low disease activity response.||36.6|12.7|<0.001
71030090|NCT01706926|141568242|SUPERIORITY_OR_OTHER||Percent difference|23.1|||<|0.001|TWO_SIDED|95.0|11.5|34.8|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|The analysis reported DAS28 (CRP) low disease activity response.||34.8|11.5|<0.001
71030091|NCT01706926|141568242|SUPERIORITY_OR_OTHER||Percent difference|33.1|||<|0.001|TWO_SIDED|95.0|20.7|45.6|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|The analysis reported DAS28 (CRP) low disease activity response.||45.6|20.7|<0.001
71030092|NCT01706926|141568243|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.68|STANDARD_ERROR_OF_MEAN|1.237|<|0.001|TWO_SIDED|95.0|-8.12|-3.24|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in swollen joint count at Day 169.||-3.24|-8.12|<0.001
71030093|NCT01706926|141568243|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.21|STANDARD_ERROR_OF_MEAN|1.211|<|0.001|TWO_SIDED|95.0|-8.6|-3.82|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in swollen joint count at Day 169.||-3.82|-8.60|<0.001
71030094|NCT01706926|141568243|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.0|STANDARD_ERROR_OF_MEAN|1.219|<|0.001|TWO_SIDED|95.0|-9.4|-4.59|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in swollen joint count at Day 169.||-4.59|-9.40|<0.001
71030095|NCT01706926|141568243|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.24|STANDARD_ERROR_OF_MEAN|1.922|<|0.001|TWO_SIDED|95.0|-11.02|-3.45|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in tender joint count at Day 169.||-3.45|-11.02|<0.001
71030096|NCT01706926|141568243|SUPERIORITY_OR_OTHER||Adjusted mean difference|-8.45|STANDARD_ERROR_OF_MEAN|1.884|<|0.001|TWO_SIDED|95.0|-12.16|-4.74|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in tender joint count at Day 169.||-4.74|-12.16|<0.001
71030097|NCT01706926|141568243|SUPERIORITY_OR_OTHER||Adjusted mean difference|-10.42|STANDARD_ERROR_OF_MEAN|1.901|<|0.001|TWO_SIDED|95.0|-14.17|-6.67|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in tender joint count at Day 169.||-6.67|-14.17|<0.001
71030098|NCT01706926|141568244|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.94|STANDARD_ERROR_OF_MEAN|3.95||0.045|TWO_SIDED|95.0|-15.72|-0.17|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-0.17|-15.72|0.045
71030099|NCT01706926|141568244|SUPERIORITY_OR_OTHER||Adjusted mean difference|-8.11|STANDARD_ERROR_OF_MEAN|3.876||0.037|TWO_SIDED|95.0|-15.73|-0.48|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-0.48|-15.73|0.037
71030100|NCT01706926|141568244|SUPERIORITY_OR_OTHER||Adjusted mean difference|-11.32|STANDARD_ERROR_OF_MEAN|3.899||0.004|TWO_SIDED|95.0|-19.0|-3.65|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-3.65|-19.00|0.004
71030101|NCT01706926|141568245|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.85|STANDARD_ERROR_OF_MEAN|4.137||0.837|TWO_SIDED|95.0|-8.99|7.29|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||7.29|-8.99|0.837
71030102|NCT01706926|141568245|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.19|STANDARD_ERROR_OF_MEAN|4.058||0.589|TWO_SIDED|95.0|-10.18|5.79|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||5.79|-10.18|0.589
71030103|NCT01706926|141568245|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.48|STANDARD_ERROR_OF_MEAN|4.083||0.18|TWO_SIDED|95.0|-13.52|2.55|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||2.55|-13.52|0.180
71030104|NCT01706926|141568246|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.41|STANDARD_ERROR_OF_MEAN|0.397|<|0.001|TWO_SIDED|95.0|-2.2|-0.63|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-0.63|-2.20|<0.001
71030105|NCT01706926|141568246|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.46|STANDARD_ERROR_OF_MEAN|0.389|<|0.001|TWO_SIDED|95.0|-2.23|-0.69|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-0.69|-2.23|<0.001
71030106|NCT01706926|141568246|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.56|STANDARD_ERROR_OF_MEAN|0.391|<|0.001|TWO_SIDED|95.0|-2.33|-0.79|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-0.79|-2.33|<0.001
71030107|NCT01706926|141568247|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.108||0.479|TWO_SIDED|95.0|-0.29|0.14|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||0.14|-0.29|0.479
71030108|NCT01706926|141568247|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.106||0.124|TWO_SIDED|95.0|-0.37|0.04|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||0.04|-0.37|0.124
71030109|NCT01706926|141568247|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.107||0.017|TWO_SIDED|95.0|-0.47|-0.05|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-0.05|-0.47|0.017
71030110|NCT01706926|141568248|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.64||||0.017|TWO_SIDED|95.0|0.45|0.92|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio \<1 favored mavrilimumab.|||0.92|0.45|0.017
71030111|NCT01706926|141568248|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.46|||<|0.001|TWO_SIDED|95.0|0.32|0.66|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio \<1 favored mavrilimumab.|||0.66|0.32|<0.001
71030112|NCT01706926|141568248|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.44|||<|0.001|TWO_SIDED|95.0|0.31|0.63|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio \<1 favored mavrilimumab.|||0.63|0.31|<0.001
71030113|NCT01706926|141568249|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.72||||0.003|TWO_SIDED|95.0|0.58|0.89|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio \<1 favored mavrilimumab.|||0.89|0.58|0.003
71030114|NCT01706926|141568249|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.68|||<|0.001|TWO_SIDED|95.0|0.55|0.84|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio \<1 favored mavrilimumab.|||0.84|0.55|<0.001
71030115|NCT01706926|141568249|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.61|||<|0.001|TWO_SIDED|95.0|0.49|0.75|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio \<1 favored mavrilimumab.|||0.75|0.49|<0.001
71030116|NCT01706926|141568250|SUPERIORITY_OR_OTHER||Percent difference|4.9||||0.21|TWO_SIDED|95.0|-0.8|10.7|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||10.7|-0.8|0.210
71030117|NCT01706926|141568250|SUPERIORITY_OR_OTHER||Percent difference|1.1||||1|TWO_SIDED|95.0|-2.9|5.1|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||5.1|-2.9|1.000
71030118|NCT01706926|141568250|SUPERIORITY_OR_OTHER||Percent difference|3.8||||0.207|TWO_SIDED|95.0|-1.6|9.2|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||9.2|-1.6|0.207
71030119|NCT01706926|141568251|SUPERIORITY_OR_OTHER||Percent difference|4.9||||0.21|TWO_SIDED|95.0|-0.8|10.7|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||10.7|-0.8|0.210
71030120|NCT01706926|141568251|SUPERIORITY_OR_OTHER||Percent difference|2.3||||0.621|TWO_SIDED|95.0|-2.3|6.9|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||6.9|-2.3|0.621
71030121|NCT01706926|141568251|SUPERIORITY_OR_OTHER||Percent difference|6.4||||0.062|TWO_SIDED|95.0|0.0|12.7|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||12.7|0.0|0.062
71030122|NCT01706926|141568252|SUPERIORITY_OR_OTHER||Percent difference|3.7||||0.245|TWO_SIDED|95.0|-0.4|7.8|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||7.8|-0.4|0.245
71030123|NCT01706926|141568252|SUPERIORITY_OR_OTHER||Percent difference|1.2||||1|TWO_SIDED|95.0|-1.1|3.5|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||3.5|-1.1|1.000
71030124|NCT01706926|141568252|SUPERIORITY_OR_OTHER||Percent difference|1.3||||0.494|TWO_SIDED|95.0|-1.2|3.7|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||3.7|-1.2|0.494
71030125|NCT01706926|141568253|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.18|STANDARD_ERROR_OF_MEAN|1.608||0.463|TWO_SIDED|95.0|-1.99|4.35|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \>0 favored mavrilimumab.|||4.35|-1.99|0.463
71030126|NCT01706926|141568253|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.27|STANDARD_ERROR_OF_MEAN|1.574||0.151|TWO_SIDED|95.0|-0.83|5.37|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \>0 favored mavrilimumab.|||5.37|-0.83|0.151
71030127|NCT01706926|141568253|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.92|STANDARD_ERROR_OF_MEAN|1.578||0.014|TWO_SIDED|95.0|0.81|7.02|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \>0 favored mavrilimumab.|||7.02|0.81|0.014
71030128|NCT00414466|141568256|SUPERIORITY_OR_OTHER|||||||0.802||95.0||||The a priori threshold for statistical significance was 0.05, two-sided.|Williams test for minimum effective dose|||Williams' test for Minimum Effective Dose was used to compare each active group to the placebo.||||0.802
71030129|NCT00414466|141568256|SUPERIORITY_OR_OTHER|||||||0.874||95.0||||The a priori threshold for statistical significance was 0.05, two-sided.|Williams test for minimum effective dose|||Williams' test for Minimum Effective Dose was used to compare each active group to the placebo.||||0.874
71030130|NCT00414466|141568256|SUPERIORITY_OR_OTHER|||||||0.899||95.0||||The a priori threshold for statistical significance was 0.05, two-sided.|Williams test for minimum effective dose|||Williams' test for Minimum Effective Dose was used to compare each active group to the placebo.||||0.899
71030131|NCT00414466|141568257|SUPERIORITY_OR_OTHER|||||||1||95.0||||The a priori threshold for statistical significance was 0.05, two-sided. Hochberg's adjustment for multiple comparisons was used.|Fisher Exact|||||||1.000
71030132|NCT00414466|141568257|SUPERIORITY_OR_OTHER|||||||1||95.0||||The a priori threshold for statistical significance was 0.05, two-sided. Hochberg's adjustment for multiple comparisons was used.|Fisher Exact|||||||1.000
71030133|NCT00414466|141568257|SUPERIORITY_OR_OTHER|||||||1||95.0||||The a priori threshold for statistical significance was 0.05, two-sided. Hochberg's adjustment for multiple comparisons was used.|Fisher Exact|||||||1.000
71030134|NCT00414466|141568258|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||The a priori threshold for statistical significance was 0.05, two-sided. No adjustments for multiple comparisons were used.|Fisher Exact|||||||0.083
71030135|NCT00414466|141568258|SUPERIORITY_OR_OTHER|||||||1||95.0||||The a priori threshold for statistical significance was 0.05, two-sided. No adjustments for multiple comparisons were used.|Fisher Exact|||||||1.000
71030136|NCT00414466|141568258|SUPERIORITY_OR_OTHER|||||||0.352||95.0||||The a priori threshold for statistical significance was 0.05, two-sided. No adjustments for multiple comparisons were used.|Fisher Exact|||||||0.352
71030137|NCT02937701|141568271|EQUIVALENCE|Clinical equivalence for the primary endpoint was to be evaluated sequentially by first comparing the 2-sided 90% CI for RD of ACR20 at week 22 between ABP 710 and infliximab with an equivalence margin of (-15%, 15%). If the first test was successful, RD of ACR20 at week 22 was to be further evaluated by comparing the 2-sided 90% CI between ABP 710 and infliximab with an equivalence margin of (-12%, 15%).|Response Difference|9.37|||||TWO_SIDED|90.0|2.67|15.96||||||For the primary analysis of ACR20, the response difference (RD) was estimated by the Mantel-Haenszel (MH) estimate and the 90% confidence intervals (CIs) of RD were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use for RA).||15.96|2.67|
71030138|NCT02937701|141568271|EQUIVALENCE|Clinical equivalence for the primary endpoint was to be evaluated sequentially by first comparing the 2-sided 90% CI for RD of ACR20 at week 22 between ABP 710 and infliximab with an equivalence margin of (-15%, 15%). If the first test was successful, RD of ACR20 at week 22 was to be further evaluated by comparing the 2-sided 90% CI between ABP 710 and infliximab with an equivalence margin of (-12%, 15%).|Response Difference|9.3|||||TWO_SIDED|90.0|2.67|15.92|||||Response Difference is based on a generalized linear model with actual stratification variables (geographic region and prior biologic use for RA) as covariates in the model.|A sensitivity analysis with the RD estimate and CIs for RD of ACR20 estimated using a generalized linear model with geographic region and prior biologic use for RA as covariates was also conducted.||15.92|2.67|
71030139|NCT02937701|141568271|EQUIVALENCE|Clinical equivalence for the primary endpoint was to be evaluated sequentially by first comparing the 2-sided 90% CI for RD of ACR20 at week 22 between ABP 710 and infliximab with an equivalence margin of (-15%, 15%). If the first test was successful, RD of ACR20 at week 22 was to be further evaluated by comparing the 2-sided 90% CI between ABP 710 and infliximab with an equivalence margin of (-12%, 15%).|Response Difference|7.184|||||TWO_SIDED|90.0|0.748|13.62|||||The ACR core set includes tender joint count, swollen joint count, subject's global health assessment, investigator's global health assessment, subject's assessment of disease related pain, HAQ-DI, and CRP.|A post-hoc analysis was conducted to adjust for the impact of random imbalance in baseline demographic and disease characteristics between the 2 treatment groups. The MH estimate of RD and corresponding CIs were estimated using a nonparametric analysis of covariance method with stratification factors geographic region and prior biologic use, and adjustment for baseline covariates (ACR core set, age, use of oral corticosteroid, use of NSAID, body mass index categories, and methotrexate dose).||13.620|0.748|
71030140|NCT02937701|141568272|OTHER||Response Difference|8.03|||||TWO_SIDED|90.0|1.15|14.81||||||The response difference at week 2 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||14.81|1.15|
71030141|NCT02937701|141568272|OTHER||Response Difference|4.96|||||TWO_SIDED|90.0|-1.8|11.64||||||The response difference at week 6 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||11.64|-1.80|
71030142|NCT02937701|141568272|OTHER||Response Difference|9.37|||||TWO_SIDED|90.0|-0.51|12.87||||||The response difference at week 14 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||12.87|-0.51|
71152308|NCT02446899|141796702|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.5469|TWO_SIDED|95.0|-10.6|20.0||Adjusted p-value|Cochran-Mantel-Haenszel|||The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).||20.0|-10.6|0.5469
71030143|NCT02937701|141568273|OTHER||Response Difference|3.05|||||TWO_SIDED|90.0|-5.26|11.73||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||11.73|-5.26|
71030144|NCT02937701|141568273|OTHER||Response Difference|8.5|||||TWO_SIDED|90.0|-1.18|17.97||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||17.97|-1.18|
71102629|NCT04875533|141713840|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.8|||||TWO_SIDED|95.0|0.65|0.99||||||Serotype 23F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.99|0.65|
71030145|NCT02937701|141568273|OTHER||Response Difference|3.31|||||TWO_SIDED|90.0|-4.61|11.7||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||11.70|-4.61|
71030146|NCT02937701|141568273|OTHER||Response Difference|4.06|||||TWO_SIDED|90.0|-5.4|13.4||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||13.40|-5.40|
71030147|NCT02937701|141568273|OTHER||Response Difference|0.82|||||TWO_SIDED|90.0|-7.34|9.4||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||9.40|-7.34|
71030148|NCT02937701|141568273|OTHER||Response Difference|2.79|||||TWO_SIDED|90.0|-6.86|12.34||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||12.34|-6.86|
71030149|NCT02937701|141568273|OTHER||Response Difference|-3.74|||||TWO_SIDED|90.0|-12.27|5.17||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||5.17|-12.27|
71030150|NCT02937701|141568273|OTHER||Response Difference|1.12|||||TWO_SIDED|90.0|-8.89|11.08||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||11.08|-8.89|
71030151|NCT02937701|141568273|OTHER||Response Difference|-5.25|||||TWO_SIDED|90.0|-13.24|3.29||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||3.29|-13.24|
71030152|NCT02937701|141568273|OTHER||Response Difference|-1.49|||||TWO_SIDED|90.0|-11.01|8.04||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||8.04|-11.01|
71030153|NCT02937701|141568274|OTHER||Response Difference|4.41|||||TWO_SIDED|90.0|-0.56|9.38||||||The response difference at week 2 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||9.38|-0.56|
71030154|NCT02937701|141568274|OTHER||Response Difference|1.62|||||TWO_SIDED|90.0|-4.71|7.94||||||The response difference at week 6 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||7.94|-4.71|
71030155|NCT02937701|141568274|OTHER||Response Difference|2.3|||||TWO_SIDED|90.0|-4.45|9.03||||||The response difference at week 14 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||9.03|-4.45|
71030156|NCT02937701|141568274|OTHER||Response Difference|7.09|||||TWO_SIDED|90.0|0.27|13.83||||||The response difference at week 22 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||13.83|0.27|
71030157|NCT02937701|141568275|OTHER||Response Difference|-1.33|||||TWO_SIDED|90.0|-10.4|7.62||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||7.62|-10.40|
71030158|NCT02937701|141568275|OTHER||Response Difference|3.24|||||TWO_SIDED|90.0|-7.28|13.67||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||13.67|-7.28|
71030159|NCT02937701|141568275|OTHER||Response Difference|6.52|||||TWO_SIDED|90.0|-2.62|15.48||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||15.48|-2.62|
71030160|NCT02937701|141568275|OTHER||Response Difference|10.74|||||TWO_SIDED|90.0|0.12|21.03||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||21.03|0.12|
71152309|NCT02446899|141796703|SUPERIORITY||Rate Ratio|0.67||||0.0809|TWO_SIDED|95.0|0.48|0.94||Adjusted p-value.|Negative binomial regression|||Analysed using a negative binomial regression model. The response variable in the model is the number of flares over the 52-week treatment period. The model includes covariates of treatment group, and the stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>=10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]). The logarithm of the follow-up time is used as an offset variable.||0.94|0.48|0.0809
71152310|NCT04050202|141796708|OTHER||Mean Difference (Net)|8.45|||<|0.01|TWO_SIDED||||||t-test, 2 sided||The post-intervention score is subtracted from the baseline score.|||||<0.01
71030161|NCT02937701|141568275|OTHER||Response Difference|0.56|||||TWO_SIDED|90.0|-8.54|9.59||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||9.59|-8.54|
71030162|NCT02937701|141568275|OTHER||Response Difference|2.93|||||TWO_SIDED|90.0|-7.62|13.39||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||13.39|-7.62|
71030163|NCT02937701|141568275|OTHER||Response Difference|-1.04|||||TWO_SIDED|90.0|-10.11|7.93||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||7.93|-10.11|
71030164|NCT02937701|141568275|OTHER||Response Difference|6.14|||||TWO_SIDED|90.0|-4.44|16.54||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||16.54|-4.44|
71030165|NCT02937701|141568275|OTHER||Response Difference|-5.43|||||TWO_SIDED|90.0|-14.39|3.71||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||3.71|-14.39|
71030166|NCT02937701|141568275|OTHER||Response Difference|2.98|||||TWO_SIDED|90.0|-7.51|13.37||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||13.37|-7.51|
71030167|NCT02937701|141568276|OTHER||Response Difference|-2.5|||||TWO_SIDED|90.0|-5.84|0.83||||||The response difference at week 2 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||0.83|-5.84|
71030168|NCT02937701|141568276|OTHER||Response Difference|-2.43|||||TWO_SIDED|90.0|-7.47|2.64||||||The response difference at week 6 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||2.64|-7.47|
71030169|NCT02937701|141568276|OTHER||Response Difference|5.46|||||TWO_SIDED|90.0|-0.01|10.91||||||The response difference at week 14 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||10.91|-0.01|
71030170|NCT02937701|141568276|OTHER||Response Difference|4.58|||||TWO_SIDED|90.0|-1.21|10.34||||||The response difference at week 22 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||10.34|-1.21|
71030171|NCT02937701|141568277|OTHER||Response Difference|0.2|||||TWO_SIDED|90.0|-8.12|8.02||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||8.02|-8.12|
71030172|NCT02937701|141568277|OTHER||Response Difference|-0.08|||||TWO_SIDED|90.0|-9.39|9.28||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||9.28|-9.39|
71030173|NCT02937701|141568277|OTHER||Response Difference|1.5|||||TWO_SIDED|90.0|-7.0|9.51||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||9.51|-7.00|
71030174|NCT02937701|141568277|OTHER||Response Difference|7.49|||||TWO_SIDED|90.0|-2.39|17.22||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||17.22|-2.39|
71030175|NCT02937701|141568277|OTHER||Response Difference|-0.5|||||TWO_SIDED|90.0|-9.03|7.59||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||7.59|-9.03|
71030176|NCT02937701|141568277|OTHER||Response Difference|3.39|||||TWO_SIDED|90.0|-6.41|13.14||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||13.14|-6.41|
71030177|NCT02937701|141568277|OTHER||Response Difference|-0.43|||||TWO_SIDED|90.0|-8.98|7.66||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||7.66|-8.98|
71030178|NCT02937701|141568277|OTHER||Response Difference|7.87|||||TWO_SIDED|90.0|-2.13|17.68||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||17.68|-2.13|
71152311|NCT04050202|141796709|OTHER||Mean Difference (Net)|13.97|||<|0.01|TWO_SIDED||||||t-test, 2 sided||The post-intervention score is subtracted from the baseline score|||||<0.01
71030179|NCT02937701|141568277|OTHER||Response Difference|1.95|||||TWO_SIDED|90.0|-6.81|10.29||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||10.29|-6.81|
71030180|NCT02937701|141568277|OTHER||Response Difference|12.06|||||TWO_SIDED|90.0|1.74|22.04||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||22.04|1.74|
71030181|NCT02937701|141568278|OTHER||Mean Difference|-0.07|||||TWO_SIDED|90.0|-0.2|0.007||||||Week 2 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.007|-0.20|
71030182|NCT02937701|141568278|OTHER||Mean Difference|0.0|||||TWO_SIDED|90.0|-0.17|0.16||||||Week 6 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.16|-0.17|
71030183|NCT02937701|141568278|OTHER||Mean Difference|-0.04|||||TWO_SIDED|90.0|-0.21|0.14||||||Week 14 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.14|-0.21|
71030184|NCT02937701|141568278|OTHER||Mean Difference|-0.01|||||TWO_SIDED|90.0|-0.2|0.17||||||Week 22 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.17|-0.20|
71030185|NCT02937701|141568279|OTHER||Mean Difference|0.16|||||TWO_SIDED|90.0|-0.08|0.4||||||Week 30 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.40|-0.08|
71030186|NCT02937701|141568279|OTHER||Mean Difference|0.0|||||TWO_SIDED|90.0|-0.27|0.28||||||Week 30 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.28|-0.27|
71030187|NCT02937701|141568279|OTHER||Mean Difference|0.11|||||TWO_SIDED|90.0|-0.12|0.35||||||Week 34 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.35|-0.12|
71030188|NCT02937701|141568279|OTHER||Mean Difference|-0.03|||||TWO_SIDED|90.0|-0.3|0.24||||||Week 34 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.24|-0.30|
71030189|NCT02937701|141568279|OTHER||Mean Difference|0.06|||||TWO_SIDED|90.0|-0.18|0.3||||||Week 38 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.30|-0.18|
71030190|NCT02937701|141568279|OTHER||Mean Difference|-0.08|||||TWO_SIDED|90.0|-0.36|0.2||||||Week 38 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.20|-0.36|
71030191|NCT02937701|141568279|OTHER||Mean Difference|0.11|||||TWO_SIDED|90.0|-0.14|0.37||||||Week 46 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.37|-0.14|
71030192|NCT02937701|141568279|OTHER||Mean Difference|-0.05|||||TWO_SIDED|90.0|-0.34|0.25||||||Week 46 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.25|-0.34|
71030193|NCT02937701|141568279|OTHER||Mean Difference|0.0|||||TWO_SIDED|90.0|-0.24|0.24||||||Week 50 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.24|-0.24|
71030194|NCT02937701|141568279|OTHER||Mean Difference|-0.2|||||TWO_SIDED|90.0|-0.47|0.08||||||Week 50 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.08|-0.47|
71030195|NCT03290326|141568283|OTHER||||||<|0.01|||||||ANOVA|||One-way ANOVA was conducted to compare the effect of 40Hz tACS on EEG gamma-band spectral power. Power changes were expressed as percentage relative power variations, accordingly with the event-related synchronization/desynchronization (ERS/ERD) index.||||< 0.01
71030196|NCT03422653|141568287|SUPERIORITY||Odds Ratio (OR)|2.72|||<|0.001|TWO_SIDED|95.0|1.72|4.3|||Cui, Hung, Wang|||||4.30|1.72|<0.001
71030197|NCT03422653|141568288|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|-2.0|-0.5|||ANCOVA|||||-0.5|-2.0|<0.001
71030198|NCT03422653|141568289|SUPERIORITY||Mean Difference (Final Values)|-5.1|STANDARD_ERROR_OF_MEAN|1.44|<|0.001|TWO_SIDED|95.0|-8.0|-2.3|||ANCOVA|||||-2.3|-8.0|<0.001
71030199|NCT03422653|141568290|SUPERIORITY||Odds Ratio (OR)|2.89|||<|0.001|TWO_SIDED|95.0|1.75|4.76|||Cui, Hung, Wang|||||4.76|1.75|<0.001
71030200|NCT01101022|141568291|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.2|||<|0.0001|TWO_SIDED|95.0|-15.9|-6.4|||ANCOVA|||||-6.4|-15.9|<0.0001
71030201|NCT01101022|141568292|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.6|||<|0.0001|TWO_SIDED|95.0|13.5|29.7|||ANCOVA|||Performance and Daily Functioning||29.7|13.5|<0.0001
71030202|NCT01101022|141568292|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.9|||<|0.0001|TWO_SIDED|95.0|7.8|22.0|||ANCOVA|||Daily Interference||22.0|7.8|<0.0001
71030203|NCT01101022|141568292|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.5||||0.0003|TWO_SIDED|95.0|6.3|20.7|||ANCOVA|||Bother/Concern||20.7|6.3|0.0003
71030204|NCT01101022|141568292|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.8||||0.0302|TWO_SIDED|95.0|0.8|14.9|||ANCOVA|||Relationships/Communication||14.9|0.8|0.0302
71030205|NCT01101022|141568293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9||||0.0016|TWO_SIDED|95.0|-7.8|-1.9|||ANCOVA|||Global Executive Composite||-1.9|-7.8|0.0016
71030206|NCT01101022|141568293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1||||0.0355|TWO_SIDED|95.0|-6.0|-0.2|||ANCOVA|||Behavioral Regulation Index||-0.2|-6.0|0.0355
71030207|NCT01101022|141568293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.7||||0.0003|TWO_SIDED|95.0|-8.7|-2.7|||ANCOVA|||Metacognition Index||-2.7|-8.7|0.0003
71030208|NCT01101022|141568294|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.4||||0.0002|TWO_SIDED|95.0|-12.7|-4.0|||ANCOVA|||Behavioral Regulation Index||-4.0|-12.7|0.0002
71030209|NCT01101022|141568294|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.6|||<|0.0001|TWO_SIDED|95.0|-16.3|-7.0|||ANCOVA|||Metacognition Index||-7.0|-16.3|<0.0001
71030210|NCT01101022|141568295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.3||||0.0001|TWO_SIDED|95.0|-12.6|-4.1|||ANCOVA|||Inhibit||-4.1|-12.6|0.0001
71030211|NCT01101022|141568295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.7||||0.0018|TWO_SIDED|95.0|-10.8|-2.5|||ANCOVA|||Shift||-2.5|-10.8|0.0018
71030212|NCT01101022|141568295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.2||||0.0056|TWO_SIDED|95.0|-8.8|-1.5|||ANCOVA|||Emotional control||-1.5|-8.8|0.0056
71030213|NCT01101022|141568295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.2||||0.0001|TWO_SIDED|95.0|-12.3|-4.1|||ANCOVA|||Sef-monitor||-4.1|-12.3|0.0001
71030214|NCT01101022|141568295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.3|||<|0.0001|TWO_SIDED|95.0|-13.2|-5.4|||ANCOVA|||Initiate||-5.4|-13.2|<0.0001
71030215|NCT01101022|141568295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.3|||<|0.0001|TWO_SIDED|95.0|-16.0|-6.6|||ANCOVA|||Working memory||-6.6|-16.0|<0.0001
71030216|NCT01101022|141568295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.9|||<|0.0001|TWO_SIDED|95.0|-15.4|-6.4|||ANCOVA|||Plan/Organize||-6.4|-15.4|<0.0001
71030217|NCT01101022|141568295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.3||||0.0001|TWO_SIDED|95.0|-14.0|-4.7|||ANCOVA|||Task monitor||-4.7|-14.0|0.0001
71030218|NCT01101022|141568295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.9|||<|0.0001|TWO_SIDED|95.0|-12.5|-5.3|||ANCOVA|||Organization of materials||-5.3|-12.5|<0.0001
71030219|NCT01101022|141568296|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.4||||0.0048|TWO_SIDED|95.0|-7.4|-1.4|||ANCOVA|||Inhibit||-1.4|-7.4|0.0048
71030220|NCT01101022|141568296|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.8||||0.0045|TWO_SIDED|95.0|-8.0|-1.5|||ANCOVA|||Shift||-1.5|-8.0|0.0045
71030221|NCT01101022|141568296|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3||||0.3605|TWO_SIDED|95.0|-4.0|1.5|||ANCOVA|||Emotional control||1.5|-4.0|0.3605
71030222|NCT01101022|141568296|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.2||||0.1468|TWO_SIDED|95.0|-5.1|0.8|||ANCOVA|||Self-monitor||0.8|-5.1|0.1468
71030223|NCT01101022|141568296|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.5||||0.0002|TWO_SIDED|95.0|-8.3|-2.7|||ANCOVA|||Initiate||-2.7|-8.3|0.0002
71030224|NCT01101022|141568296|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.3||||0.0004|TWO_SIDED|95.0|-9.8|-2.9|||ANCOVA|||Working memory||-2.9|-9.8|0.0004
71030225|NCT01101022|141568296|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9||||0.0015|TWO_SIDED|95.0|-7.9|-1.9|||ANCOVA|||Plan/Organize||-1.9|-7.9|0.0015
71030226|NCT01101022|141568296|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.3||||0.0003|TWO_SIDED|95.0|-9.7|-2.9|||ANCOVA|||Task monitor||-2.9|-9.7|0.0003
71030227|NCT01101022|141568296|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2||||0.0234|TWO_SIDED|95.0|-5.9|-0.4|||ANCOVA|||Organization of materials||-0.4|-5.9|0.0234
71030228|NCT01101022|141568297|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.1|||<|0.0001|TWO_SIDED|95.0|-14.9|-7.3|||ANCOVA|||||-7.3|-14.9|<0.0001
71030229|NCT01101022|141568300|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
71030230|NCT01101022|141568301|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.1|||<|0.0001|TWO_SIDED|95.0|5.4|12.7|||ANCOVA|||Living with ADHD||12.7|5.4|<0.0001
71030231|NCT01101022|141568301|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.8|||<|0.0001|TWO_SIDED|95.0|6.0|15.5|||ANCOVA|||General Well-being||15.5|6.0|<0.0001
71030232|NCT01101022|141568302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5||||0.0184|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|||Question 1||1.0|0.1|0.0184
71030233|NCT01101022|141568302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.0004|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|||Question 4||-0.3|-0.9|0.0004
71030234|NCT01101022|141568303|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.5||||0.0019|TWO_SIDED|95.0|-9.0|-2.1|||ANCOVA|||||-2.1|-9.0|0.0019
71030235|NCT01101022|141568304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.1||||0.0017|TWO_SIDED|95.0|-8.2|-1.9|||ANCOVA|||Inattention/Memory Problems||-1.9|-8.2|0.0017
71030236|NCT01101022|141568304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1||||0.0174|TWO_SIDED|95.0|-7.5|-0.7|||ANCOVA|||Hyperactivity/Restlessness||-0.7|-7.5|0.0174
71030237|NCT01101022|141568304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.0||||0.0063|TWO_SIDED|95.0|-6.8|-1.1|||ANCOVA|||Impulsivity/Emotional Liability||-1.1|-6.8|0.0063
71030238|NCT01101022|141568304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.4||||0.0059|TWO_SIDED|95.0|-7.5|-1.3|||ANCOVA|||Problems with Self-concept||-1.3|-7.5|0.0059
71030239|NCT01101022|141568305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.0||||0.0016|TWO_SIDED|95.0|8.4|33.6|||ANCOVA|||Life Productivity||33.6|8.4|0.0016
71030240|NCT01101022|141568305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.1||||0.0242|TWO_SIDED|95.0|1.6|22.5|||ANCOVA|||Psychological Health||22.5|1.6|0.0242
71030241|NCT01101022|141568305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.5||||0.0038|TWO_SIDED|95.0|4.2|20.8|||ANCOVA|||Life Outlook||20.8|4.2|0.0038
71030242|NCT01101022|141568305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.3||||0.1752|TWO_SIDED|95.0|-3.4|18.0|||ANCOVA|||Relationships||18.0|-3.4|0.1752
71030243|NCT01101022|141568305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.7||||0.0015|TWO_SIDED|95.0|5.9|23.6|||ANCOVA|||Total Score||23.6|5.9|0.0015
71030244|NCT01604850|141568357|SUPERIORITY_OR_OTHER||Proportion difference|-22.4|||<|0.001|TWO_SIDED|95.0|-34.4|-10.3||P-value is from the Cochran-Mantel-Haenszel (CMH) test stratified by the randomization stratification factor (ie, presence/absence of cirrhosis, genotype 2 or 3).|Cochran-Mantel-Haenszel||The difference in proportions between treatment groups and associated 95% confidence interval (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions.|A sample size of 100 subjects in each group would provide over 97% power to detect at least 20% improvement in SVR12 rate from the assumed null rate of 25% using 2-sided exact 1-sample binomial test at significance level of 0.025.||-10.3|-34.4|< 0.001
71030245|NCT00243932|141568363|SUPERIORITY_OR_OTHER_LEGACY|||||||0.14||95.0|||||futility (non-superiority)|||Null hypothesis: 2,700mg CoQ10 is at least 20% superior to placebo.||||0.14
71030246|NCT00849901|141568374|SUPERIORITY_OR_OTHER|||||||0.999||95.0|||||Mixed Models Analysis|||||||0.999
71030247|NCT00437658|141568391|NON_INFERIORITY|Statistical non-inferiority was defined when the lower bound of the 95% 2-sided confidence interval for the difference between an elagolix dose and DMPA-SC in the response rate was no less than -20% at week 24 for both dysmenorrhea and non-menstrual pelvic pain.|Difference in response rates|-0.3||||0.963|TWO_SIDED|95.0|-13.4|12.7|||Pearson chi-squared||Difference in response rate = elogolix - DMPA-SC|||12.7|-13.4|0.9630
71030248|NCT00437658|141568391|NON_INFERIORITY|Statistical non-inferiority was defined when the lower bound of the 95% 2-sided confidence interval for the difference between an elagolix dose and DMPA-SC in the response rate was no less than -20% at week 24 for both dysmenorrhea and non-menstrual pelvic pain.|Difference in response rates|-12.4||||0.101|TWO_SIDED|95.0|-26.7|1.8|||Pearson chi-squared||Difference in response rate = elogolix - DMPA-SC|||1.8|-26.7|0.1010
71030249|NCT00437658|141568392|NON_INFERIORITY|Statistical non-inferiority was defined when the lower bound of the 95% 2-sided confidence interval for the difference between an elagolix dose and DMPA-SC in the response rate was no less than -20% at week 24 for both dysmenorrhea and non-menstrual pelvic pain.|Difference in response rates|9.5||||0.2048|TWO_SIDED|95.0|-5.2|24.2|||Pearson chi-squared||Difference in response rates = elagolix - DMPA-SC|||24.2|-5.2|0.2048
71030250|NCT00437658|141568392|NON_INFERIORITY|Statistical non-inferiority was defined when the lower bound of the 95% 2-sided confidence interval for the difference between an elagolix dose and DMPA-SC in the response rate was no less than -20% at week 24 for both dysmenorrhea and non-menstrual pelvic pain.|Difference in response rates|0.5||||0.9544|TWO_SIDED|95.0|-15.1|16.0|||Pearson chi-squared||Difference in response rates = elagolix - DMPA-SC|||16.0|-15.1|0.9544
71030251|NCT00437658|141568395|OTHER||Least squares mean|-5.5|||<|0.0001|TWO_SIDED|95.0|-6.2|-4.8||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in total CPSSS at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-4.8|-6.2|< 0.0001
71030252|NCT00437658|141568395|OTHER||Least squares mean|-5.2|||<|0.0001|TWO_SIDED|95.0|-5.8|-4.5||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in total CPSSS at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-4.5|-5.8|< 0.0001
71030253|NCT00437658|141568395|OTHER||Least squares mean|-5.3|||<|0.0001|TWO_SIDED|95.0|-6.0|-4.6||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in total CPSSS at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-4.6|-6.0|< 0.0001
71030254|NCT00437658|141568396|OTHER||Least squares mean|-4.6|||<|0.0001|TWO_SIDED|95.0|-5.1|-4.0||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in total CPSSS excluding dyspareunia at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-4.0|-5.1|<0.0001
71102630|NCT04875533|141713841|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|0.58|||||TWO_SIDED|95.0|0.5|0.67||||||Serotype 8: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.67|0.50|
71152312|NCT01554241|141796717|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|Results presented were Bonferonni-corrected for a mid-point safety analysis||Comparisons of concentrations in D3 dosing groups at study end were made by ANOVA. Adherence of 80% was pre-specified for inclusion in analyses. .||||<.0001
71152313|NCT01554241|141796717|SUPERIORITY_OR_OTHER||||||=|0.56|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||=.56
71030255|NCT00437658|141568396|OTHER||Least squares mean|-4.4|||<|0.0001|TWO_SIDED|95.0|-5.0|-3.9||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in total CPSSS excluding dyspareunia at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-3.9|-5.0|<0.0001
71030256|NCT00437658|141568396|OTHER||Least squares mean|-4.5|||<|0.0001|TWO_SIDED|95.0|-5.1|-3.9||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in total CPSSS excluding dyspareunia at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-3.9|-5.1|< 0.0001
71030257|NCT00437658|141568397|OTHER||Least squares mean|-1.5|||<|0.0001|TWO_SIDED|95.0|-1.7|-1.2||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dysmenorrhea at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-1.2|-1.7|< 0.0001
71030258|NCT00437658|141568397|OTHER||Least squares mean|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.2||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dysmenorrhea at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-1.2|-1.6|< 0.0001
71030259|NCT00437658|141568397|OTHER||Least squares mean|-1.7|||<|0.0001|TWO_SIDED|95.0|-1.9|-1.4||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dysmenorrhea at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-1.4|-1.9|< 0.0001
71030260|NCT00437658|141568398|OTHER||Least squares mean|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dyspareunia at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.9|-1.4|< 0.0001
71030261|NCT00437658|141568398|OTHER||Least squares mean|-1.0|||<|0.0001|TWO_SIDED|2.0|-1.2|-0.7||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dyspareunia at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.7|-1.2|< 0.0001
71030262|NCT00437658|141568398|OTHER||Least squares mean|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.5||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dyspareunia at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.5|-1.1|< 0.0001
71030263|NCT00437658|141568399|OTHER||Least squares mean|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.4|-1.0||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in non-menstrual pelvic pain at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-1.0|-1.4|< 0.0001
71030264|NCT00437658|141568399|OTHER||Least squares mean|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.4|-1.0||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in non-menstrual pelvic pain at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-1.0|-1.4|< 0.0001
71030265|NCT00437658|141568399|OTHER||Least squares mean|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in non-menstrual pelvic pain at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-0.8|-1.3|< 0.0001
71152314|NCT01554241|141796717|SUPERIORITY_OR_OTHER||||||<|0.0009|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0009
71102631|NCT04875533|141713841|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|2.14|||||TWO_SIDED|95.0|1.8|2.53||||||Serotype 10A: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||2.53|1.80|
71152315|NCT01554241|141796717|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0001
71152316|NCT01554241|141796717|SUPERIORITY_OR_OTHER||||||<|0.006|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.006
71152317|NCT01554241|141796717|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0001
71030266|NCT00437658|141568400|OTHER||Least squares mean|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in pelvic tenderness at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.8|-1.2|< 0.0001
71030267|NCT00437658|141568400|OTHER||Least squares mean|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.8||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in pelvic tenderness at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.8|-1.1|< 0.0001
71030268|NCT00437658|141568400|OTHER||Least squares mean|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in pelvic tenderness at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.7|-1.1|< 0.0001
71030269|NCT00437658|141568401|OTHER||Least squares mean|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.7||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in pelvic induration at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.7|-1.0|< 0.0001
71030270|NCT00437658|141568401|OTHER||Least squares mean|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in pelvic induration at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.7|-1.1|< 0.0001
71030271|NCT00437658|141568401|OTHER||Least squares mean|-0.8|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.6|||t-test, 2 sided|||Within-group analysis of change from baseline in pelvic induration at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.6|-0.9|<0.0001
71090938|NCT05233761|141688243|SUPERIORITY|The mean nightly difference in SWS Sleep (% TST) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.3||0.0019|TWO_SIDED|95.0|0.4|1.6|||t-test, 2 sided|||The null hypothesis was that there was no difference in SWS Sleep (% TST) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||1.6|0.4|0.0019
71090939|NCT05233761|141688243|SUPERIORITY|The mean nightly difference in REM Sleep (% TST) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.4||0.52|TWO_SIDED|95.0|-0.6|1.2|||t-test, 2 sided|||The null hypothesis was that there was no difference in REM Sleep (% TST) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||1.2|-.6|0.52
71030272|NCT00437658|141568402|OTHER||Least squares mean|-32.3|||<|0.0001|TWO_SIDED|95.0|-39.2|-25.4||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in peak VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-25.4|-39.2|< 0.0001
71090940|NCT05233761|141688243|SUPERIORITY|The mean nightly difference in Light Sleep (% TST) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.6||0.004|TWO_SIDED|95.0|-2.8|-0.5|||t-test, 2 sided|||The null hypothesis was that there was no difference in Light Sleep (% TST) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||-0.5|-2.8|0.0040
71090941|NCT05233761|141688243|SUPERIORITY|The mean nightly difference in Awake Time (% TST) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.6||0.24|TWO_SIDED|95.0|-0.5|2.0|||t-test, 2 sided|||The null hypothesis was that there was no difference in Awake Time (% TST) sleep in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||2.0|-.5|0.24
71152318|NCT01554241|141796717|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0001
71090942|NCT05233761|141688244|SUPERIORITY|The mean nightly difference in SWS + REM Sleep (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|4.9|STANDARD_ERROR_OF_MEAN|2.6||0.0117|TWO_SIDED|95.0|1.7|13.3|||t-test, 2 sided|||The null hypothesis was that there was no difference in SWS + REM Sleep (min) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||13.3|1.7|0.0117
71030273|NCT00437658|141568402|OTHER||Least squares mean|-32.9|||<|0.0001|TWO_SIDED|95.0|-39.4|-26.4||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in peak VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-26.4|-39.4|< 0.0001
71030274|NCT00437658|141568402|OTHER||Least squares mean|-35.8|||<|0.0001|TWO_SIDED|95.0|-43.0|-28.6||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in peak VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-28.6|-43.0|< 0.0001
71030275|NCT00437658|141568403|OTHER||Least squares mean|-18.2|||<|0.0001|TWO_SIDED|95.0|-23.3|-13.1||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in monthly mean VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-13.1|-23.3|< 0.0001
71030276|NCT00437658|141568403|OTHER||Least squares mean|-23.4|||<|0.0001|TWO_SIDED|95.0|-28.3|-18.5||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in monthly mean VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-18.5|-28.3|< 0.0001
71030277|NCT00437658|141568403|OTHER||Least squares mean|-17.9|||<|0.0001|TWO_SIDED|95.0|-23.1|-12.7||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in peak VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-12.7|-23.1|< 0.0001
71030278|NCT02731157|141568425|OTHER||Mean Difference (Final Values)|0.65||||0.95|TWO_SIDED||||||ANOVA|||||||0.95
71030279|NCT00832377|141568431|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Week 12 peak IOP vs. baseline|paired t-test|||||||<0.0001
71030280|NCT00832377|141568432|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Week 12 trough IOP vs. baseline|paired t-test|||||||<0.0001
71030281|NCT00832377|141568433|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Week 12 8-HR IOP vs. baseline|paired t-test|||||||<0.0001
71030282|NCT02096718|141568456|SUPERIORITY_OR_OTHER||Ratio of gmeans|122.23|STANDARD_DEVIATION|28.3|||TWO_SIDED|90.0|95.743|156.045|||ANOVA||Relative bioavailability comparison of afatinib for moderate vs. normal matched with moderate patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.||156.045|95.743|
71030283|NCT02096718|141568456|SUPERIORITY_OR_OTHER||Ratio of gmeans|149.97|STANDARD_DEVIATION|41.9|||TWO_SIDED|90.0|105.266|213.671|||ANOVA||Relative bioavailability comparison of afatinib for severe vs. normal matched with severe patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.||213.671|105.266|
71030284|NCT02096718|141568457|SUPERIORITY_OR_OTHER||Ratio of gmeans|101.16|STANDARD_DEVIATION|38.5|||TWO_SIDED|90.0|72.931|140.309|||ANOVA||Relative bioavailability comparison of afatinib for moderate vs. normal matched with moderate patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.||140.309|72.931|
71152319|NCT01554241|141796718|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||analyses were corrected for multiple comparisons (Bonferroni)|ANOVA|||||||<.0001
71152320|NCT01554241|141796718|SUPERIORITY_OR_OTHER||||||=|0.47|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||=0.47
71152321|NCT01554241|141796718|SUPERIORITY_OR_OTHER||||||<|0.002|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.002
71152322|NCT01554241|141796718|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0001
71030285|NCT02096718|141568457|SUPERIORITY_OR_OTHER||Ratio of gmeans|121.71|STANDARD_DEVIATION|34.2|||TWO_SIDED|90.0|90.79|163.162|||ANOVA||Relative bioavailability comparison of afatinib for severe vs. normal matched with severe patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.||163.162|90.790|
70907260|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.263||0.3596|TWO_SIDED|95.0|-0.28|0.76|||MMRM|||Anxiety Psychic, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.76|-0.28|0.3596
71030286|NCT02096718|141568458|SUPERIORITY_OR_OTHER||Ratio of gmeans|122.44|STANDARD_DEVIATION|28.0|||TWO_SIDED|90.0|96.141|155.928|||ANOVA||Relative bioavailability comparison of afatinib for moderate vs. normal matched with moderate patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.||155.928|96.141|
71030287|NCT02096718|141568458|SUPERIORITY_OR_OTHER||Ratio of gmeans|150.08|STANDARD_DEVIATION|41.5|||TWO_SIDED|90.0|105.626|213.25|||ANOVA||Relative bioavailability comparison of afatinib for severe vs. normal matched with severe patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.||213.250|105.626|
71030288|NCT01941030|141568485|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.022|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty reduction of calcium out of lumen gain.||||0.0220
71030289|NCT01941030|141568486|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.6228|||||||t-test, 2 sided|||Null hypothesis: no difference in populations for post-balloon angioplasty minimum lumen area stenosis.||||0.6228
71030290|NCT01941030|141568487|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.4528|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty plaque area.||||0.4528
71030291|NCT01941030|141568488|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.3573|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty dense calcium area.||||0.3573
71030292|NCT01941030|141568489|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.6073|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty necrotic core area.||||0.6073
71030293|NCT01941030|141568490|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.2149|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty fibrous plaque area.||||0.2149
71030294|NCT01941030|141568491|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.0579|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty fibrofatty plaque area.||||0.0579
71030295|NCT01941030|141568492|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.076|||||||t-test, 2 sided|||Null hypothesis: no difference in populations for post-final balloon FFR value with 600 mcg adenosine.||||0.076
71030296|NCT01941030|141568492|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.205|||||||t-test, 2 sided|||Null hypothesis: no difference in populations for post-final balloon FFR value with 1200 mcg adenosine.||||0.205
71030297|NCT02268500|141568538|SUPERIORITY|||||||0.89|||||||Chi-squared|||||||0.89
71030298|NCT02268500|141568539|SUPERIORITY|||||||0.43|||||||Chi-squared|||||||0.43
71030299|NCT02268500|141568540|SUPERIORITY|||||||0.03|||||||Chi-squared|||||||0.03
71030300|NCT02268500|141568541|SUPERIORITY|||||||0.76|||||||Chi-squared|||||||0.76
71030301|NCT02268500|141568542|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
71030302|NCT01993875|141568543|SUPERIORITY|||||||0.129||||||Treatment p-value is from an analysis of co-variance (ANCOVA) using the SBM rate as the dependent variable, treatment as fixed effect, and baseline rate as random effect.|ANCOVA|||||||0.1290
71030303|NCT01993875|141568544|SUPERIORITY|||||||0.129||||||Treatment p-value is from an ANCOVA using the SBM rate as the dependent variable, treatment as fixed effect, and baseline rate as random effect.|ANCOVA|||||||0.1290
71030304|NCT01993875|141568545|SUPERIORITY|||||||0.2177||||||Treatment p-value is from an ANCOVA using the mean stool consistency score as the dependent variable, treatment as fixed effect, and the baseline consistency score as random effect.|ANCOVA|||||||0.2177
71030305|NCT01993875|141568546|SUPERIORITY|||||||0.2177||||||Treatment p-value is from an ANCOVA using the mean stool consistency score as the dependent variable, treatment as fixed effect, and the baseline consistency score as random effect.|ANCOVA|||||||0.2177
71030306|NCT01993875|141568547|SUPERIORITY|||||||0.0664||||||Treatment p-value is from an ANCOVA using the mean straining score as the dependent variable, treatment as fixed effect, and the baseline straining score as random effect.|ANCOVA|||||||0.0664
71030307|NCT01993875|141568548|SUPERIORITY|||||||0.0664||||||Treatment p-value is from an ANCOVA using the mean straining score as the dependent variable, treatment as fixed effect, and the baseline mean score as random effect.|ANCOVA|||||||0.0664
71030308|NCT02227121|141568587|SUPERIORITY_OR_OTHER||Percentage|92.86|||||ONE_SIDED|95.0|70.3|||||||Null Hypothesis: Percentage of Subjects with Successful VF Termination ≤ 65% Alternative Hypothesis: Percentage of Subjects with Successful VF Termination \> 65%|||70.3|
71030309|NCT03929367|141568588|OTHER|Modeling of change of plasma oxytocin concentration over time using nonlinear canonical compartment model.|Bayesian information criterion|2.0|||||TWO_SIDED|||||||||||||
71030310|NCT03929367|141568599|SUPERIORITY|Light touch detection frequency was compared over time in comparison to baseline using a one way analysis of variance for repeated measures. A power analysis was not performed for this secondary outcome measure.||||||0.89||||||No effect|ANOVA|||||||.89
71030311|NCT03929367|141568606|SUPERIORITY|Sustained heat score at the end of each 5 minute session was compared to baseline across time using a one-way analysis of variance for repeated measures. Power analysis was not performed for this secondary outcome measure.||||||0.014|||||||ANOVA|||||||0.014
71030312|NCT01706536|141568625|SUPERIORITY||Least Squares Mean (SE)|0.1168|STANDARD_ERROR_OF_MEAN|0.04055||0.0043|TWO_SIDED|95.0|0.0369|0.1966|||Least squares mean (SE)|In order to control for Type I error rate, a gate keeping methodology was used.||A sample size of 45 subjects per treatment arm provides approximately 80% power to detect a 0.12 L treatment difference in mean change in trough FEV1 between an active arm and the placebo arm at a significance level of 0.05 using a 2-group t-test and assumes a standard deviation for change in trough FEV1 of 200. Assuming a 20% discontinuation rate, approximately 55 subjects were enrolled into each treatment arm.||0.1966|0.0369|0.0043
71030313|NCT01706536|141568625|SUPERIORITY||Least Squares Mean (SE)|0.1284|STANDARD_ERROR_OF_MEAN|0.04089||0.0019|TWO_SIDED|95.0|0.0479|0.2089||In order to control for Type I error rate, a gate keeping methodology was used|Least squares mean (SE)|||A sample size of 45 subjects per treatment arm provides approximately 80% power to detect a 0.12 L treatment difference in mean change in trough FEV1 between an active arm and the placebo arm at a significance level of 0.05 using a 2-group t-test and assumes a standard deviation for change in trough FEV1 of 200. Assuming a 20% discontinuation rate, approximately 55 subjects were enrolled into each treatment arm.||0.2089|0.0479|0.0019
71030314|NCT01706536|141568625|SUPERIORITY||Least Squares Mean (SE)|0.1462|STANDARD_ERROR_OF_MEAN|0.04037||0.0004|TWO_SIDED|95.0|0.0667|0.2257||in order to control for Type 1 error rate, a gate keeping methodology was used|Least squares mean (SE)|||A sample size of 45 subjects per treatment arm provides approximately 80% power to detect a 0.12 L treatment difference in mean change in trough FEV1 between an active arm and the placebo arm at a significance level of 0.05 using a 2-group t-test and assumes a standard deviation for change in trough FEV1 of 200. Assuming a 20% discontinuation rate, approximately 55 subjects were enrolled into each treatment arm.||0.2257|0.0667|0.0004
71030315|NCT01706536|141568625|SUPERIORITY||Least Squares Mean (SE)|0.177|STANDARD_ERROR_OF_MEAN|0.03953|<|0.0001|TWO_SIDED|95.0|0.0992|0.2548||in order to control for type I error rate, a gate keeping methodology was used|Least squares mean (SE)|||A sample size of 45 subjects per treatment arm provides approximately 80% power to detect a 0.12 L treatment difference in mean change in trough FEV1 between an active arm and the placebo arm at a significance level of 0.05 using a 2-group t-test and assumes a standard deviation for change in trough FEV1 of 200. Assuming a 20% discontinuation rate, approximately 55 subjects were enrolled into each treatment arm.||0.2548|0.0992|<0.0001
71030316|NCT00993187|141568646|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.8|||<|0.001|TWO_SIDED|95.0|-1.0|-0.6|||ANCOVA|||||-0.6|-1.0|<0.001
71030317|NCT00993187|141568649|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-23.5|||<|0.001|TWO_SIDED|95.0|-30.0|-16.9|||ANCOVA|||||-16.9|-30.0|<0.001
71030318|NCT00993187|141568650|SUPERIORITY_OR_OTHER||Difference in percent|-14.7|||<|0.001|TWO_SIDED|95.0|-23.0|-7.0|||ANCOVA|||||-7.0|-23.0|<0.001
71030319|NCT00993187|141568651|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-1.72|||<|0.001|TWO_SIDED|95.0|-2.2|-1.25|||ANCOVA|||||-1.25|-2.20|<0.001
71030320|NCT00993187|141568652|SUPERIORITY_OR_OTHER||Difference in percent|41.01|||<|0.001|TWO_SIDED|95.0|30.0|51.0|||ANCOVA|||||51.0|30.0|<0.001
71030321|NCT00234078|141568701|SUPERIORITY_OR_OTHER|||||||0.385||||||versus placebo|t-test, 2 sided|a general linear model||||||0.385
71030322|NCT00234078|141568702|SUPERIORITY_OR_OTHER|||||||0.601||||||versus placebo|t-test, 2 sided|a general linear model||||||0.601
71030323|NCT00234078|141568703|SUPERIORITY_OR_OTHER|||||||0.084||||||p-value is adjusted for multiple comparisons|t-test, 2 sided|||||||0.084
71030324|NCT00234078|141568703|SUPERIORITY_OR_OTHER|||||||0.02||||||p-value is adjusted for multiple comparisons|t-test, 2 sided|||||||0.020
71030325|NCT00234078|141568703|SUPERIORITY_OR_OTHER|||||||0.421||||||p-value is adjusted for multiple comparisons|t-test, 2 sided|||||||0.421
71030326|NCT00234078|141568704|SUPERIORITY_OR_OTHER|||||||0.087||||||p-value is adjusted for multiple comparisons|t-test, 2 sided|||||||0.087
71030327|NCT00234078|141568704|SUPERIORITY_OR_OTHER|||||||0.004||||||p-value is adjusted for multiple comparisons|t-test, 2 sided|||||||0.004
71030328|NCT00234078|141568704|SUPERIORITY_OR_OTHER|||||||0.029||||||p-value is adjusted for multiple comparisons|t-test, 2 sided|||||||0.029
71030329|NCT04455633|141568710|SUPERIORITY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.249||0.007|TWO_SIDED|95.0|-1.16|-0.18|||MMRM model|||Mixed model repeated measures (MMRM) model included fixed effects of treatment, visit, treatment-by-week interaction, the randomization stratum of Baseline pain severity (moderate, severe), and the Baseline ADPS score as a covariate.||-0.18|-1.16|0.007
71152323|NCT01554241|141796718|SUPERIORITY_OR_OTHER||||||<|0.02|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.02
71152324|NCT01554241|141796718|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0001
71030330|NCT04455633|141568710|SUPERIORITY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.254||0.03|TWO_SIDED|95.0|-1.06|-0.05|||MMRM model|||MMRM model included fixed effects of treatment, visit, treatment-by-week interaction, the randomization stratum of Baseline pain severity (moderate, severe), and the Baseline ADPS score as a covariate.||-0.05|-1.06|0.030
71030331|NCT04455633|141568711|SUPERIORITY||Difference in Percentage of Responders|9.6||||0.091|TWO_SIDED|95.0|-1.55|20.76|||Cochran-Mantel-Haenszel|||Percentage of responders were analyzed using the Cochran-Mantel-Haenszel (CMH) test stratified by the randomization factor of Baseline severity score (moderate, severe). The 95% confidence interval (CI) are calculated using the asymptotic Wald method. Missing observations at Week 6 are imputed as nonresponses.||20.76|-1.55|0.091
71030332|NCT04455633|141568711|SUPERIORITY||Difference in Percentage of Responders|-0.8||||0.883|TWO_SIDED|95.0|-10.95|9.4|||Cochran-Mantel-Haenszel|||Percentage of responders were analyzed using the CMH test stratified by the randomization factor of Baseline severity score (moderate, severe). The 95% CI are calculated using the asymptotic Wald method. Missing observations at Week 6 are imputed as nonresponses.||9.40|-10.95|0.883
71030333|NCT04455633|141568712|SUPERIORITY||Difference in Percentage of Responders|4.8||||0.289|TWO_SIDED|95.0|-4.11|13.73|||Cochran-Mantel-Haenszel|||Percentage of responders were analyzed using the CMH test stratified by the randomization factor of Baseline severity score (moderate, severe). The 95% CI are calculated using the asymptotic Wald method. Missing observations at Week 6 are imputed as nonresponses.||13.73|-4.11|0.289
71030334|NCT04455633|141568712|SUPERIORITY||Difference in Percentage of Responders|-0.8||||0.837|TWO_SIDED|95.0|-8.85|7.16|||Cochran-Mantel-Haenszel|||Percentage of responders were analyzed using the CMH test stratified by the randomization factor of Baseline severity score (moderate, severe). The 95% CI are calculated using the asymptotic Wald method. Missing observations at Week 6 are imputed as nonresponses.||7.16|-8.85|0.837
71030335|NCT04455633|141568713|SUPERIORITY||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.298||0.014|TWO_SIDED|95.0|-1.32|-0.15|||MMRM model|||Pain at its Worst: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain at its worst score as a covariate.||-0.15|-1.32|0.014
71030336|NCT04455633|141568713|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.29||0.017|TWO_SIDED|95.0|-1.27|-0.13|||MMRM model|||Pain at its Worst: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain at its worst score as a covariate.||-0.13|-1.27|0.017
71030337|NCT04455633|141568713|SUPERIORITY||LS Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.302||0.015|TWO_SIDED|95.0|-1.33|-0.15|||MMRM model|||Pain at its Least: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain at its least score as a covariate.||-0.15|-1.33|0.015
71030338|NCT04455633|141568713|SUPERIORITY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.294||0.02|TWO_SIDED|95.0|-1.27|-0.11|||MMRM model|||Pain at its Least: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain at its least score as a covariate.||-0.11|-1.27|0.020
71030339|NCT04455633|141568713|SUPERIORITY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.309||0.005|TWO_SIDED|95.0|-1.48|-0.27|||MMRM model|||Pain Right Now: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain right now score as a covariate.||-0.27|-1.48|0.005
71030340|NCT04455633|141568713|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.301||0.111|TWO_SIDED|95.0|-1.07|0.11|||MMRM model|||Pain Right Now: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain right now score as a covariate.||0.11|-1.07|0.111
71030341|NCT04455633|141568713|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.31||0.399|TWO_SIDED|95.0|-0.87|0.35|||MMRM model|||Interference score averaged Over Questions 9A - G: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain interference score as a covariate.||0.35|-0.87|0.399
71030342|NCT04455633|141568713|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.302||0.441|TWO_SIDED|95.0|-0.83|0.36|||MMRM model|||Interference score averaged Over Questions 9A - G: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain interference score as a covariate.||0.36|-0.83|0.441
71030343|NCT04455633|141568713|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.346||0.575|TWO_SIDED|95.0|-0.87|0.49|||MMRM model|||General Activity: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline general activity score as a covariate.||0.49|-0.87|0.575
71030344|NCT04455633|141568713|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.337||0.88|TWO_SIDED|95.0|-0.71|0.61|||MMRM model|||General Activity: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline general activity score as a covariate.||0.61|-0.71|0.880
71030345|NCT04455633|141568713|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.368||0.978|TWO_SIDED|95.0|-0.73|0.71|||MMRM model|||Mood: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline mood score as a covariate.||0.71|-0.73|0.978
71152325|NCT01554241|141796718|SUPERIORITY_OR_OTHER||||||<|0.0003|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0003
71152326|NCT02974543|141796724|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71030346|NCT04455633|141568713|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.358||0.877|TWO_SIDED|95.0|-0.65|0.76|||MMRM model|||Mood: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline mood score as a covariate.||0.76|-0.65|0.877
71030347|NCT04455633|141568713|SUPERIORITY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.354||0.079|TWO_SIDED|95.0|-1.32|0.07|||MMRM model|||Walking Ability: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline walking ability score as a covariate.||0.07|-1.32|0.079
71030348|NCT04455633|141568713|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.345||0.163|TWO_SIDED|95.0|-1.16|0.2|||MMRM model|||Walking Ability: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline walking ability score as a covariate.||0.20|-1.16|0.163
71030349|NCT04455633|141568713|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.344||0.875|TWO_SIDED|95.0|-0.73|0.62|||MMRM model|||Normal Work: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline normal work score as a covariate.||0.62|-0.73|0.875
71030350|NCT04455633|141568713|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.335||0.914|TWO_SIDED|95.0|-0.69|0.62|||MMRM model|||Normal Work: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline normal work score as a covariate.||0.62|-0.69|0.914
71030351|NCT04455633|141568713|SUPERIORITY||LS Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.351||0.219|TWO_SIDED|95.0|-0.26|1.12|||MMRM model|||Relations with Other People: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline relations with other people score as a covariate.||1.12|-0.26|0.219
71030352|NCT04455633|141568713|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.341||0.551|TWO_SIDED|95.0|-0.47|0.87|||MMRM model|||Relations with Other People: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline relations with other people score as a covariate.||0.87|-0.47|0.551
71030353|NCT04455633|141568713|SUPERIORITY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.339||0.005|TWO_SIDED|95.0|-1.63|-0.3|||MMRM model|||Sleep: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline sleep score as a covariate.||-0.30|-1.63|0.005
71030354|NCT04455633|141568713|SUPERIORITY||LS Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.329||0.002|TWO_SIDED|95.0|-1.68|-0.39|||MMRM model|||Sleep: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline sleep score as a covariate.||-0.39|-1.68|0.002
71030355|NCT04455633|141568713|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.361||0.955|TWO_SIDED|95.0|-0.73|0.69|||MMRM model|||Enjoyment of Life: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline enjoyment of life score as a covariate.||0.69|-0.73|0.955
71030356|NCT04455633|141568713|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.351||0.777|TWO_SIDED|95.0|-0.79|0.59|||MMRM model|||Enjoyment of Life: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline enjoyment of life score as a covariate.||0.59|-0.79|0.777
71030357|NCT04455633|141568715|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.163||0.031|TWO_SIDED|95.0|-0.67|-0.03|||ANOVA|||Analysis of variance (ANOVA) model was used for the analysis with treatment and the randomization stratum of baseline pain severity (moderate, severe) as fixed covariates.||-0.03|-0.67|0.031
71030358|NCT04455633|141568715|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.165||0.351|TWO_SIDED|95.0|-0.48|0.17|||ANOVA|||ANOVA model was used for the analysis with treatment and the randomization stratum of baseline pain severity (moderate, severe) as fixed covariates.||0.17|-0.48|0.351
71030359|NCT02532764|141568729|SUPERIORITY||Difference vs placebo|12.91|STANDARD_ERROR_OF_MEAN|6.53||0.0592|TWO_SIDED|95.0|-0.54|26.35||p-values are presented for Day 33.|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||26.35|-0.54|0.0592
71030360|NCT02532764|141568729|SUPERIORITY||difference vs placebo|19.13|STANDARD_ERROR_OF_MEAN|6.56||0.0074|TWO_SIDED|95.0|5.62|32.64||p-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||32.64|5.62|0.0074
71030361|NCT02532764|141568729|SUPERIORITY||difference vs placebo|14.24|STANDARD_ERROR_OF_MEAN|6.6||0.0408|TWO_SIDED|95.0|0.64|27.83||p-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||27.83|0.64|0.0408
71030362|NCT02532764|141568729|SUPERIORITY||difference vs placebo|3.46|STANDARD_ERROR_OF_MEAN|6.87||0.6193|TWO_SIDED|95.0|-10.69|17.6||p-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||17.60|-10.69|0.6193
71030363|NCT02532764|141568731|SUPERIORITY||Difference vs placebo|23.17|STANDARD_ERROR_OF_MEAN|9.73||0.0321|TWO_SIDED|95.0|2.29|44.04||p-values are presented for Day 33.|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||44.04|2.29|0.0321
71030364|NCT02532764|141568731|SUPERIORITY||Difference vs placebo|27.3|STANDARD_ERROR_OF_MEAN|9.17||0.01|TWO_SIDED|95.0|7.64|46.96||p-values are presented for Day 33.|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||46.96|7.64|0.0100
71030365|NCT02532764|141568731|SUPERIORITY||Difference vs placebo|20.16|STANDARD_ERROR_OF_MEAN|8.62||0.0346|TWO_SIDED|95.0|1.68|38.64||p-values are presented for Day 33.|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||38.64|1.68|0.0346
71030366|NCT02532764|141568731|SUPERIORITY||Difference vs placebo|10.84|STANDARD_ERROR_OF_MEAN|9.01||0.2485|TWO_SIDED|95.0|-8.47|30.16||p-values are presented for Day 33.|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||30.16|-8.47|0.2485
71030367|NCT02532764|141568733|SUPERIORITY||difference vs placebo|4.24|STANDARD_ERROR_OF_MEAN|3.18||0.1938|TWO_SIDED|95.0|-2.3|10.79||P-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline ppFEV1 as outcome variable and including treatment, baseline ppFEV1 value, time and interaction between time and treatment as covariate||10.79|-2.30|0.1938
71030368|NCT02532764|141568733|SUPERIORITY||difference vs placebo|2.75|STANDARD_ERROR_OF_MEAN|3.18||0.3943|TWO_SIDED|95.0|-3.79|9.29||P-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline ppFEV1 as outcome variable and including treatment, baseline ppFEV1 value, time and interaction between time and treatment as covariates.||9.29|-3.79|0.3943
71030369|NCT02532764|141568733|SUPERIORITY||difference vs placebo|0.53|STANDARD_ERROR_OF_MEAN|3.18||0.8688|TWO_SIDED|95.0|-6.01|7.07||P-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline ppFEV1 as outcome variable and including treatment, baseline ppFEV1 value, time and interaction between time and treatment as covariates.||7.07|-6.01|0.8688
71090943|NCT05233761|141688244|SUPERIORITY|The mean nightly difference in SWS Sleep (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|1.3||0.0126|TWO_SIDED|95.0|0.7|5.9|||t-test, 2 sided|||The null hypothesis was that there was no difference in SWS Sleep (min) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||5.9|0.7|0.0126
71030370|NCT02532764|141568733|SUPERIORITY||difference vs placebo|-0.51|STANDARD_ERROR_OF_MEAN|3.35||0.8813|TWO_SIDED|95.0|-7.41|6.39||P-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline ppFEV1 as outcome variable and including treatment, baseline ppFEV1 value, time and interaction between time and treatment as covariates.||6.39|-7.41|0.8813
71030371|NCT02532764|141568735|SUPERIORITY||Difference vs placebo|10.19|STANDARD_ERROR_OF_MEAN|4.22||0.0301|TWO_SIDED|95.0|1.13|19.25||P-values are presented for Day 33|Mixed Models Analysis|||||19.25|1.13|0.0301
71030372|NCT02532764|141568735|SUPERIORITY||Difference vs placebo|7.99|STANDARD_ERROR_OF_MEAN|3.91||0.0601|TWO_SIDED|95.0|-0.39|16.37||P-values are presented for Day 33|Mixed Models Analysis|||||16.37|-0.39|0.0601
71030373|NCT02532764|141568735|SUPERIORITY||Difference vs placebo|3.5|STANDARD_ERROR_OF_MEAN|3.69||0.358|TWO_SIDED|95.0|-4.4|11.41||P-values are presented for Day 33|Mixed Models Analysis|||||11.41|-4.40|0.3580
71030374|NCT02532764|141568735|SUPERIORITY||Difference vs placebo|3.21|STANDARD_ERROR_OF_MEAN|3.89||0.4224|TWO_SIDED|95.0|-5.13|11.55||P-values are presented for Day 33|Mixed Models Analysis|||||11.55|-5.13|0.4224
71030375|NCT01027780|141568741|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||Please note that this analysis tested the differences between groups following the intervention.|GEE|Generalized estimating equations (GEE) approach was used to assess robustness of population parameters, such as treatment effects.||||||.007
71030376|NCT01027780|141568742|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||Note that this is the p value for differences between groups immediately following the intervention|GEE|Generalized estimating equations (GEE) approach was used to assess robustness of population parameters, such as treatment effects.||||||.04
71030377|NCT01027780|141568743|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Difference between groups following intervention|ANOVA|||||||.03
71030378|NCT04099888|141568774|SUPERIORITY||||||||TWO_SIDED|95.0|||||||||The HR was estimated using an unstratified cox-proportional hazards model using the Efron approach for handling ties (Efron 1977), together with the associated 95% confidence intervals (CI) for the HR based on the Wald method. The effect of treatment is summarized by the hazard ratio (HR) together with its corresponding 95% Wald CI for the mITT population. No p-value will be reported.|||
71102632|NCT04875533|141713841|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|1.72|||||TWO_SIDED|95.0|1.44|2.06||||||Serotype 11A: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||2.06|1.44|
71152327|NCT02974543|141796725|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71030379|NCT04099888|141568775|SUPERIORITY||||||||TWO_SIDED|95.0||||||||OS was analyzed using the modified intent-to-treat (mITT) analysis set, which included all randomized participants who received at least 1 dose of study treatment and had a RECIST assessment at baseline. Kaplan Meier Curve (KM) analysis of OS was completed for the mITT population, but the number of events was too small to draw any conclusions.|The HR was estimated using an unstratified cox-proportional hazards model using the Efron approach for handling ties (Efron 1977), together with the associated 95% confidence intervals (CI) for the HR based on the Wald method. The effect of treatment is summarized by the hazard ratio (HR) together with its corresponding 95% Wald CI for the mITT population. No p-value will be reported.|||
71030380|NCT04099888|141568776|SUPERIORITY|||||||||||||||||BOR is summarized by randomized treatment group using the mITT analysis set.|The BOR is the best response recorded from the start of the treatment until disease progression or until the last evaluable assessment in the absence of progression. If a patient received subsequent anti-cancer therapy prior to progression, then BOR was calculated up to the point of starting the anti-cancer therapy.|||
71030381|NCT04099888|141568777|SUPERIORITY||||||||TWO_SIDED|95.0|||||||||The ORR is calculated as the proportion of patients who have at least one visit response with a complete response (CR) or partial response (PR). Objective responses do not require confirmation in a randomized study. Data obtained up until progression, or last evaluable assessment in the absence of progression, will be included in the analysis of ORR. Data obtained up until progression or subsequent therapy, or last evaluable assessment in the absence of progression or subsequent therapy, will be included in the analysis of ORR.|||
71030382|NCT04099888|141568778|SUPERIORITY|||||||||||||||||The DoR was calculated only for those with a documented response of CR or PR and is defined as the time from the date of first documented tumor response until the first date of documented disease progression or death, whichever is earlier.|DoR is listed only. In Arm A, the duration of response was 169 days in 1 participant before radiological progression was seen. In the other 2 participants in Arm A, the events were censored at 260 and 264 days, respectively. In Arm B, the duration of response was 85 days in 1 participant before radiological progression was seen. In the other 2 participants in Arm B, the events were censored at 1 day due to the early termination of the study.|||
71030383|NCT04099888|141568779|SUPERIORITY||||||||TWO_SIDED|95.0||||||||DCR is reported and includes any patient with a best response of stable disease, PR or CR.|The DCR and associated exact 95% CI is summarized for the mITT population. This was repeated for DCR-6, defined as the proportion of patients with CR, PR or SD at 6 months (recorded at least 24 weeks (+/-1 week) after randomization of study treatment and prior to any PD event).|||
71030384|NCT04099888|141568780|SUPERIORITY|||||||||||||||||Change in tumor size in percentage was summarized for the subset of patients in the mITT analysis set who had measurable disease at baseline.|Tumor size is defined as the sum of the longest diameters (SoDs) of the RECIST 1.1 target lesions. Change in tumor size is defined as the best overall percentage change in tumor size from baseline. Percentage change in tumor size was determined for patients with measurable disease at baseline and was derived at each visit by the percentage change in the SoDs of target lesions compared to baseline.|||
71090944|NCT05233761|141688244|SUPERIORITY|The mean nightly difference in REM sleep (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|2.0||0.51|TWO_SIDED|95.0|-2.7|5.3|||t-test, 2 sided|||The null hypothesis was that there was no difference in REM Sleep (min) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||5.3|-2.7|0.51
71030385|NCT04099888|141568781|SUPERIORITY||||||||||||||||||Safety, including the incidence and characteristics of biliary/loco-regional tumour-related events leading to hospitalisation and/or interventions, will be summarised descriptively.|||
71030386|NCT04099888|141568782|SUPERIORITY||||||||||||||||||Safety events leading to hospitalisation and/or interventions, will be summarised descriptively.|||
71030387|NCT04099888|141568786|SUPERIORITY||||||||||||||||||As this study was terminated early, a reduced statistical analysis was conducted, and the HRQoL analyses were not conducted.|||
71030388|NCT04538170|141568787|SUPERIORITY|||||||0.013||||||threshold for statistical significance|Fisher Exact|||Preliminary work showed that approximately 25% of patients report phantom pain after orchidectomy. A difference of 20% between the GAC and ORC groups was considered relevant. Power was set to 80% and the significance level to 5%, resulting in a minimum of 40 women to be recruited, which was fulfilled.||||0.013
71152328|NCT02549365|141796769|OTHER||Odds Ratio (OR)|2.89|||||TWO_SIDED|95.0|0.6|13.9|||||Incidence of laboratory confirmed influenza is compared between those vaccinated and household controls. VE will be calculated as 1 - RR with 95% confidence intervals using Poisson regression.|||13.9|0.6|
71030389|NCT00637299|141568790|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 1 sided|||||||<0.01
71030390|NCT00637299|141568791|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||||||<0.05
71030391|NCT00445003|141568808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.6|||<|0.001|TWO_SIDED|95.0|2.2|9.0||adjusted for baseline visual acuity, number of planned panretinal photocoagulation sittings, and correlation between two study eyes|ANCOVA||adjusted for multiple comparison|||9.0|2.2|<.001
71030392|NCT00445003|141568808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|||<|0.001|TWO_SIDED|95.0|3.2|10.1||adjusted for baseline visual acuity, number of planned panretinal photocoagulation sittings, and correlation between two study eyes|ANCOVA||adjusted for multiple comparisons|||10.1|3.2|<.001
71030393|NCT00445003|141568810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.0|||<|0.01|TWO_SIDED|95.0|-64.0|-6.0||Adjusted for baseline optical coherence tomography retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons|||-6|-64|<.01
71030394|NCT00445003|141568810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-100.0|||<|0.001|TWO_SIDED|95.0|-128.0|-71.0||adjusted for baseline optical coherence tomography retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons|||-71|-128|<.001
71030395|NCT00445003|141568812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9||||0.44|TWO_SIDED|95.0|-3.7|7.5||Adjusted for baseline visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons|||7.5|-3.7|0.44
71030396|NCT00445003|141568812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.63|TWO_SIDED|95.0|-4.4|6.8||Adjusted for baseline visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons|||6.8|-4.4|0.63
71030397|NCT00445003|141568815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.001|TWO_SIDED|95.0|-1.0|-0.2||adjusted for baseline retinal volume, optical coherence tomography retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons|||-0.2|-1.0|0.001
71030398|NCT00445003|141568815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.1|-1.3||adjusted for baseline retinal volume, optical coherence tomography retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons|||-1.3|-2.1|<.001
71030399|NCT00864097|141568830|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.2||0.039|TWO_SIDED|95.0|-0.81|-0.02|||ANCOVA|||LS means were estimated from the corresponding analysis of covariance (ANCOVA) model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.02|-0.81|0.039
71030400|NCT00864097|141568830|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.2||0.011|TWO_SIDED|95.0|-0.91|-0.12|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.12|-0.91|0.011
71030401|NCT00864097|141568830|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.2||0.005|TWO_SIDED|95.0|-0.97|-0.17|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.17|-0.97|0.005
71030402|NCT00864097|141568831|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.2||0.01|TWO_SIDED|95.0|-0.91|-0.12|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.12|-0.91|0.010
71030403|NCT00864097|141568831|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.2||0.002|TWO_SIDED|95.0|-1.03|-0.23|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.23|-1.03|0.002
71008428|NCT03018028|141524710|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.31||||0.7147|TWO_SIDED|95.0|0.31|5.56||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 7 mg / Liraglutide 0.9 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||5.56|0.31|0.7147
71030404|NCT00864097|141568831|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.1|-0.3|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.30|-1.10|<0.001
71030405|NCT00864097|141568832|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.08||0.022|TWO_SIDED|95.0|-0.32|-0.03|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.03|-0.32|0.022
71030406|NCT00864097|141568832|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.02|TWO_SIDED|95.0|-0.33|-0.03|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.03|-0.33|0.020
71030407|NCT00864097|141568832|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.08||0.002|TWO_SIDED|95.0|-0.4|-0.09|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.09|-0.40|0.002
71030408|NCT00864097|141568833|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.17||0.957|TWO_SIDED|95.0|-0.32|0.34|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.34|-0.32|0.957
71030409|NCT00864097|141568833|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.17||0.899|TWO_SIDED|95.0|-0.31|0.35|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.35|-0.31|0.899
71102633|NCT04875533|141713841|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|1.68|||||TWO_SIDED|95.0|1.39|2.04||||||Serotype 12F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||2.04|1.39|
71152329|NCT00531661|141796797|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Negative Binomial Regression|||||||0.0002
71030410|NCT00864097|141568833|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.17||0.022|TWO_SIDED|95.0|0.06|0.72|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.72|0.06|0.022
71030411|NCT00864097|141568833|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.18||0.052|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.00|-0.70|0.052
71030412|NCT00864097|141568833|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.05|-0.34|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.34|-1.05|<0.001
71030413|NCT00864097|141568833|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.18||0.008|TWO_SIDED|95.0|-0.84|-0.13|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.13|-0.84|0.008
71030414|NCT00864097|141568833|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.19||0.058|TWO_SIDED|95.0|-0.72|0.01|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.01|-0.72|0.058
71030415|NCT00864097|141568833|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.05|-0.32|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.32|-1.05|<0.001
71030416|NCT00864097|141568833|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.12|-0.38|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.38|-1.12|<0.001
71030417|NCT00864097|141568833|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.19||0.007|TWO_SIDED|95.0|-0.91|-0.15|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.15|-0.91|0.007
71030418|NCT00864097|141568833|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.18|-0.41|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.41|-1.18|<0.001
71030419|NCT00864097|141568833|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.05|-0.28|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.28|-1.05|<0.001
71030420|NCT00864097|141568834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.15||0.754|TWO_SIDED|95.0|-0.25|0.35|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.35|-0.25|0.754
71030421|NCT00864097|141568834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.16||0.706|TWO_SIDED|95.0|-0.36|0.25|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.25|-0.36|0.706
71030422|NCT00864097|141568834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.16||0.266|TWO_SIDED|95.0|-0.13|0.48|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.48|-0.13|0.266
71030423|NCT00864097|141568834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.18||0.195|TWO_SIDED|95.0|-0.58|0.12|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.12|-0.58|0.195
71030424|NCT00864097|141568834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.07|-0.36|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.36|-1.07|<0.001
71030425|NCT00864097|141568834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.18||0.019|TWO_SIDED|95.0|-0.78|-0.07|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.07|-0.78|0.019
71030426|NCT00864097|141568834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.18||0.126|TWO_SIDED|95.0|-0.64|0.08|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.08|-0.64|0.126
71030427|NCT00864097|141568834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.1|-0.37|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.37|-1.10|<0.001
71030428|NCT00864097|141568834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.19||0.001|TWO_SIDED|95.0|-0.98|-0.25|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.25|-0.98|0.001
71030429|NCT00864097|141568834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.19||0.007|TWO_SIDED|95.0|-0.9|-0.15|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.15|-0.90|0.007
71030430|NCT00864097|141568834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.21|-0.44|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.44|-1.21|<0.001
71030431|NCT00864097|141568834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.2||0.001|TWO_SIDED|95.0|-1.02|-0.25|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.25|-1.02|0.001
71030432|NCT00864097|141568835|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.2|TWO_SIDED|95.0|-0.22|0.05|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.05|-0.22|0.200
71030433|NCT00864097|141568835|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.754|TWO_SIDED|95.0|-0.15|0.11|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.11|-0.15|0.754
71030434|NCT00864097|141568835|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.07||0.449|TWO_SIDED|95.0|-0.08|0.18|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.18|-0.08|0.449
71030435|NCT00864097|141568835|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.062|TWO_SIDED|95.0|-0.27|0.01|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.01|-0.27|0.062
71030436|NCT00864097|141568835|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED|95.0|-0.36|-0.08|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.08|-0.36|0.002
71030437|NCT00864097|141568835|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.026|TWO_SIDED|95.0|-0.3|-0.02|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.02|-0.30|0.026
71030438|NCT00864097|141568835|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.032|TWO_SIDED|95.0|-0.31|-0.01|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.01|-0.31|0.032
71030439|NCT00864097|141568835|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.48|-0.19|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.19|-0.48|<0.001
71030440|NCT00864097|141568835|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.45|-0.16|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.16|-0.45|<0.001
71030441|NCT00864097|141568835|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.07||0.038|TWO_SIDED|95.0|-0.3|-0.01|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.01|-0.30|0.038
71030442|NCT00864097|141568835|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.07||0.003|TWO_SIDED|95.0|-0.37|-0.07|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.07|-0.37|0.003
71030443|NCT00864097|141568835|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.016|TWO_SIDED|95.0|-0.33|-0.03|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.03|-0.33|0.016
71030444|NCT00262223|141568859|SUPERIORITY_OR_OTHER_LEGACY||Incidence Rate Ratio|1.6||||0.34|TWO_SIDED|95.0|0.61|4.23|||Generalized Estimating Equations|Negative binomial models with log link were applied to the alcohol consumption measure.||Between group analyses were conducted of time-by-treatment interaction that included the four study time points (baseline, end-of-treatment, 6-mos and 12-mos).||4.23|0.61|0.34
71030445|NCT00262223|141568860|SUPERIORITY_OR_OTHER_LEGACY||Parameter Estimate|-16.15||||0.04|TWO_SIDED|95.0|-31.18|-1.13||A trend-level time-by-treatment interaction (p = .096) was probed for simple effects, which revealed a significantly greater reduction in CAPS scores at end-of-treatment in the SS+Sertraline group relative to the SS+Placebo group.|Generalized Estimating Equations|||Generalized estimating equations (GEE) were utilized to model PTSD outcomes. This method is an extension of the generalized linear model that handles correlated data arising from repeated measurements, requires no parametric distribution assumption, and provides robust inference with respect to misspecification of the within-subject correlation. A temporal within-subjects autoregressive \[AR(1)\] correlation matrix was used to model participants across timepoints.||-1.13|-31.18|0.04
71030446|NCT03828734|141568861|SUPERIORITY|||||||0.263|||||||ANOVA|||||||0.263
71030447|NCT03828734|141568862|SUPERIORITY||||||<|1e-06|||||||ANOVA|||||||<0.000001
71030448|NCT03828734|141568863|SUPERIORITY|||||||0.399|||||||ANOVA|||||||0.399
71152330|NCT00531661|141796798|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||exact test of binomial proportions|P-value from exact test of binomial proportions compared proportion of all implantation cases free from DSRC to OPC of 0.80.||"Analysis of DSRC was based on the following pre-specified objective performance criteria: the lower limit of the two-sided 95.2% confidence interval on the freedom from DSRC rate for all implantation cases was at least 80%. The statistical hypotheses were:~Null: (Freedom from device / system-related complications) ≤ 80%~Alternative: (Freedom from device / system-related complications) \> 80%"||||<0.0001
71030449|NCT01328093|141568869|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-3.2|STANDARD_ERROR_OF_MEAN|0.7|<|0.001||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||<0.001
71030450|NCT01328093|141568870|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||95.0||||P-value is for ≥7% increase.|Cochran-Mantel-Haenszel|||||||0.110
71030451|NCT01328093|141568870|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value is for ≥7% decrease.|Cochran-Mantel-Haenszel|||||||<0.001
71030452|NCT01328093|141568871|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.04|STANDARD_ERROR_OF_MEAN|0.04||0.353||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.353
71030453|NCT01328093|141568872|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.03|STANDARD_ERROR_OF_MEAN|0.09||0.698||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.698
71030454|NCT01328093|141568873|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.924||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.924
71030455|NCT01328093|141568874|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|3.55|STANDARD_ERROR_OF_MEAN|1.77||0.045||95.0||||P-value is for PANSS Total Score. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.045
71030456|NCT01328093|141568874|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|1.21|STANDARD_ERROR_OF_MEAN|0.56||0.032||95.0||||P-value is for PANSS Positive Score. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.032
71030457|NCT01328093|141568874|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.36|STANDARD_ERROR_OF_MEAN|0.54||0.509||95.0||||P-value is for PANSS Negative Score. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.509
71030458|NCT01328093|141568874|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|2.05|STANDARD_ERROR_OF_MEAN|1.0||0.04||95.0||||P-value is for PANSS General Psychopathology Score. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.040
71030459|NCT01328093|141568875|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|1.1|STANDARD_ERROR_OF_MEAN|2.1||0.601||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.601
71030460|NCT01328093|141568876|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.322||95.0||||P-value is for ER/Facility (Psych) visits. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.322
71008429|NCT03018028|141524710|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.97||||0.3765|TWO_SIDED|95.0|0.44|8.85||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 14 mg / Liraglutide 0.9 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||8.85|0.44|0.3765
71030461|NCT01328093|141568876|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.04|STANDARD_ERROR_OF_MEAN|0.02||0.099||95.0||||P-value is for ER/Facility (Non-Psych) visits. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.099
71030462|NCT01328093|141568876|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.787||95.0||||P-value is for Outpatient (Non-Psych or Dentist) visits. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.787
71030463|NCT01328093|141568877|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.02|STANDARD_ERROR_OF_MEAN|0.12||0.892||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.892
71030464|NCT01328093|141568878|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.8|STANDARD_ERROR_OF_MEAN|1.6||0.63||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.630
71030465|NCT01328093|141568879|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.5|STANDARD_ERROR_OF_MEAN|1.2||0.679||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.679
71030466|NCT01328093|141568880|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.17|STANDARD_ERROR_OF_MEAN|0.09||0.055||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.055
71030467|NCT01328093|141568881|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.15|STANDARD_ERROR_OF_MEAN|1.11||0.891||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.891
71030468|NCT01328093|141568883|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064||95.0||||P-value is for Treatment-Emergent Suicidal Ideation.|Fisher Exact|||||||0.064
71030469|NCT01328093|141568883|SUPERIORITY_OR_OTHER_LEGACY|||||||0.205||95.0||||P-value is for Treatment-Emergent Suicidal Behavior.|Fisher Exact|||||||0.205
71030470|NCT05150964|141568888|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05, Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (NAL/National Acoustic Laboratory or DSL/Desired Sensation Level) and ASG (Adaptive Situational Gain) setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor.~Null hypothesis: The hearing aid fitting prescription will have no effect on the speech reception thresholds."||||<0.05
71030471|NCT05150964|141568888|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05, Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (NAL/National Acoustic Laboratory or DSL/Desired Sensation Level) and ASG (Adaptive Situational Gain) setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor.~Null hypothesis: The ASG setting will have no effect on the speech reception threshold."||||>0.05
71030472|NCT05150964|141568889|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null Hypothesis: The ASG setting will have no effect on the Word Recognition Scores."||||<0.05
71030473|NCT05150964|141568889|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null Hypothesis: The presentation level will have no effect on the Word Recognition Scores."||||<0.05
71030474|NCT05150964|141568889|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null Hypothesis: Hearing aid prescription will have no effect on the Word Recognition Scores."||||<0.05
71030475|NCT05150964|141568890|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Presentation level will have no effect on multi-word recognition scores."||||<0.05
71030476|NCT05150964|141568890|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: The ASG setting will have no effect on multi-word recognition scores."||||>0.05
71030477|NCT05150964|141568890|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Hearing aid prescription will have no effect on multi-word recognition scores."||||>0.05
71030478|NCT05150964|141568891|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Presentation level will have no effect on Nonword Detection scores."||||<0.05
71030479|NCT05150964|141568891|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Hearing aid prescription will have no effect on Nonword Detection scores."||||<0.05
71030480|NCT05150964|141568891|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: The ASG setting will have no effect on Nonword Detection scores."||||>0.05
71030481|NCT05150964|141568892|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: The ASG setting will have no effect on Rapid Word Learning scores."||||>0.05
71030482|NCT05150964|141568892|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Presentation level will have no effect on Rapid Word Learning scores."||||>0.05
71030483|NCT05150964|141568892|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Hearing aid prescripton will have no effect on Rapid Word Learning scores."||||>0.05
71030484|NCT03661528|141568894|OTHER||Percentage proportion difference|13.4||||0.0032|TWO_SIDED|95.0|4.6|22.2|||Cochran-Mantel-Haenszel|||||22.2|4.6|0.0032
71030485|NCT03661528|141568895|OTHER||Difference in least squares mean|-185.99|||<|0.0001|TWO_SIDED|95.0|-199.93|-172.05|||ANCOVA|Analysis presented for ANCOVA based on ranks.||||-172.05|-199.93|<0.0001
71030486|NCT03553823|141568904|SUPERIORITY||Difference secukinumab vs guselkumab|20.0||||0.1715|TWO_SIDED|95.0|-13.3|50.3|||Fisher Exact|The statistical model was the Fisher's exact test for the difference in proportions.||"Proportion of subjects whose plaque achieves clear or almost clear status (TCS = 0-2)"||50.3|-13.3|0.1715
71152331|NCT00531661|141796799|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||exact test of binomial proportions|P-value from exact test of binomial proportions compared proportion of all implanted patients free from pressure sensor failure to OPC of 0.90.||"Analysis of sensor failures was based on the following pre-specified objective performance criteria: the lower limit of the two-sided 95.2% confidence interval on the freedom from pressure sensor failure rate for all patients implanted was at least 90%. The statistical hypotheses were:~Null: (Freedom from device / system-related complications) ≤ 90%~Alternative: (Freedom from device / system-related complications) \> 90%"||||<0.0001
71152332|NCT00531661|141796800|SUPERIORITY_OR_OTHER|||||||0.0077||95.0|||||ANCOVA|||||||0.0077
71030487|NCT03682900|141568927|SUPERIORITY||||||=|0||||||A one tailed test was used, as the intervention is expected to be superior than the control group. The criterion for significance was p \<. 05.|Mixed Models Analysis|There were no adjustments made for multiple comparisons.||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||= .000
71030488|NCT03682900|141568928|SUPERIORITY||||||=|0||||||"The a prior threshold for statistical significance is set at p\<.05; one tailed test, as the intervention is expected to be superior than the control group.~The p-value is not adjusted for multiple comparisons."|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition||||= .000
71030489|NCT03682900|141568929|SUPERIORITY||||||=|0.044||||||"The a prior threshold for statistical significance is set at p\<.05; one tailed test, as the intervention is expected to be superior than the control group.~The p-value is not adjusted for multiple comparisons."|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||=.044
71030490|NCT03682900|141568930|SUPERIORITY||||||=|0.033||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for significance is p\<.05.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||=.033
71030491|NCT03682900|141568931|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
71030492|NCT03682900|141568932|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
71030493|NCT03682900|141568933|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
71030494|NCT03682900|141568934|SUPERIORITY||||||<|0.001||||||"The a prior threshold for statistical significance is set at p\<.05; one tailed test, as the intervention is expected to be superior than the control group.~The p-value is not adjusted for multiple comparisons."|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
71030495|NCT03682900|141568935|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
71030496|NCT03682900|141568936|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were anlyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
71030497|NCT03682900|141568937|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
71030498|NCT03682900|141568938|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were anlyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
71090945|NCT05233761|141688244|SUPERIORITY|The mean nightly difference in Light Sleep (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|-6.8|STANDARD_ERROR_OF_MEAN|3.6||0.0574|TWO_SIDED|95.0|-13.7|0.2|||t-test, 2 sided|||The null hypothesis was that there was no difference in Light Sleep (min) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||0.2|-13.7|0.0574
71152333|NCT00531661|141796801|SUPERIORITY_OR_OTHER|||||||0.0292||95.0|||||Fisher Exact|||||||0.0292
71030499|NCT03682900|141568939|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a gneral linear mixed model with students nested within schools and schools nested within condition.||||<.001
71030500|NCT03682900|141568940|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were anlayzed using a general linear mixed model with students nested within schools and schools within condition.||||<.001
71152334|NCT00531661|141796802|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0280
71152335|NCT00531661|141796803|SUPERIORITY_OR_OTHER|||||||0.0236||95.0|||||t-test, 2 sided|||||||0.0236
71152336|NCT00531661|141796804|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Negative Binomial Regression|||||||<0.0001
71030501|NCT03682900|141568941|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. Apriori, a p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed uisng a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
71030502|NCT03682900|141568942|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is a priori considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear model with students nested within schools and schools nested within condition.||||<.001
71030503|NCT03682900|141568943|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
71030504|NCT03682900|141568944|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
71030505|NCT03682900|141568945|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were anlyzed using a general linear model mixed model with students nested within schools and schools nested within condition.||||<.001
71030506|NCT03682900|141568946|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
71030507|NCT03682900|141568947|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schols and schools nested within condition.||||<.001
71030508|NCT03682900|141568948|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
71030509|NCT04448678|141568952|OTHER|||||||0.0401|||||||t-test, 2 sided|||||||0.0401
71030510|NCT04448678|141568953|OTHER|||||||0.0049|||||||t-test, 2 sided|||||||0.0049
71030511|NCT04448678|141568954|OTHER|||||||0.297|||||||t-test, 2 sided|||||||0.297
71030512|NCT01312922|141568979|SUPERIORITY||Odds Ratio (OR)|0.987||||1|TWO_SIDED|95.0|0.456|2.14|||Fisher Exact|||||2.140|0.456|1.000
71030513|NCT01312922|141568979|SUPERIORITY||Odds Ratio (OR)|1.031||||1|TWO_SIDED|95.0|0.476|2.233|||Fisher Exact|||||2.233|0.476|1.000
71030514|NCT00515203|141568987|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Cochran-Mantel-Haenszel|||||||0.0019
71030515|NCT00515203|141568988|SUPERIORITY_OR_OTHER|||||||0.3651|||||||Cochran-Mantel-Haenszel|||||||0.3651
71030516|NCT00515203|141568989|SUPERIORITY_OR_OTHER|||||||0.0008|||||||Fisher Exact|||||||0.0008
71030517|NCT00515203|141568990|SUPERIORITY_OR_OTHER|||||||0.0008|||||||Fisher Exact|||||||0.0008
71030518|NCT00515203|141568991|SUPERIORITY_OR_OTHER|||||||0.2098|||||||Fisher Exact|||||||0.2098
71030519|NCT01569152|141568993|SUPERIORITY_OR_OTHER||Difference of percentages|43.9|||<|0.001|TWO_SIDED|95.0|24.52|63.28|||Cochran-Mantel-Haenszel|||||63.28|24.52|<0.001
71030520|NCT01569152|141568994|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.98|||<|0.001|TWO_SIDED|95.0|-1.53|-0.43|||Constrained Longitudinal Data Analysis|||||-0.43|-1.53|<0.001
71030521|NCT01569152|141568995|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.11|||<|0.001|TWO_SIDED|95.0|-1.62|-0.6|||Constrained Longitudinal Data Analysis|||||-0.60|-1.62|<0.001
71030522|NCT01569152|141568996|SUPERIORITY_OR_OTHER||Difference in percentages|14.63||||0.044|TWO_SIDED|95.0|0.83|28.44|||Cochran-Mantel-Haenszel|||||28.44|0.83|0.044
71030523|NCT01569152|141568999|SUPERIORITY_OR_OTHER||Difference in percentages|31.71||||0.004|TWO_SIDED|95.0|11.29|52.13|||Cochran-Mantel-Haenszel|||||52.13|11.29|0.004
71030524|NCT01569152|141569000|SUPERIORITY_OR_OTHER||Difference in percentages|29.27||||0.007|TWO_SIDED|95.0|8.9|49.63|||Cochran-Mantel-Haenszel|||||49.63|8.90|0.007
71030525|NCT01569152|141569001|SUPERIORITY_OR_OTHER||Difference in percentages|9.76||||0.039|TWO_SIDED|95.0|0.67|18.84|||Cochran-Mantel-Haenszel|||||18.84|0.67|0.039
71030526|NCT01569152|141569002|SUPERIORITY_OR_OTHER||Difference in percentages|12.2||||0.018|TWO_SIDED|95.0|2.18|22.21|||Cochran-Mantel-Haenszel|||||22.21|2.18|0.018
71030527|NCT01569152|141569005|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.75||||0.028|TWO_SIDED|95.0|-8.99|-0.52|||Constrained Longitudinal Data Analysis|||||-0.52|-8.99|0.028
71030528|NCT01569152|141569006|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.65||||0.11|TWO_SIDED|95.0|-5.91|0.62|||Constrained Longitudinal Data Analysis|||||0.62|-5.91|0.110
71030529|NCT01569152|141569007|SUPERIORITY_OR_OTHER||Difference in least squares means|-10.56||||0.002|TWO_SIDED|95.0|-16.97|-4.15|||Constrained Longitudinal Data Analysis|||||-4.15|-16.97|0.002
71030530|NCT01569152|141569010|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.84|||<|0.001|TWO_SIDED|95.0|-29.98|-11.71|||Constrained Longitudinal Data Analysis|||||-11.71|-29.98|<0.001
71030531|NCT01569152|141569011|SUPERIORITY_OR_OTHER||Difference in least squares means|-19.48|||<|0.001|TWO_SIDED|95.0|-29.69|-9.28|||Constrained Longitudinal Data Analysis|||||-9.28|-29.69|<0.001
71030532|NCT01569152|141569012|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.69|||<|0.001|TWO_SIDED|95.0|-31.29|-10.09|||Constrained Longitudinal Data Analysis|||||-10.09|-31.29|<0.001
71030533|NCT01569152|141569013|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.62|||<|0.001|TWO_SIDED|95.0|-0.84|-0.4|||Constrained Longitudinal Data Analysis|||||-0.40|-0.84|< 0.001
71030534|NCT01569152|141569014|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.59||||0.007|TWO_SIDED|95.0|-2.73|-0.45|||Constrained Longitudinal Data Analysis|||||-0.45|-2.73|0.007
71030535|NCT01569152|141569015|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.9||||0.315|TWO_SIDED|95.0|-14.54|4.74|||Constrained Longitudinal Data Analysis|||||4.74|-14.54|0.315
71030536|NCT01569152|141569017|SUPERIORITY_OR_OTHER||Difference in percentages|31.71|||<|0.001|TWO_SIDED|95.0|15.56|47.86|||Cochran-Mantel-Haenszel|||||47.86|15.56|<0.001
71030537|NCT00154102|141569035|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.853||||0.0479|TWO_SIDED|95.0|0.728|1.0|||Stratified log rank|Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The study was planned with 633 progression events, in order to provide 80% power to test the null hypothesis of no difference in PFS time between treatment groups, assuming a hazard ratio (HR) of 0.8 of cetuximab + chemotherapy (CTX) over CTX alone. Significance level was fixed at 5%. The two-sided stratified log-rank test was employed, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and Karnovsky Performance Scale (KPS):\<80 vs. ≥80)||1.000|0.728|0.0479
71030538|NCT00154102|141569036|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.696||||0.0012|TWO_SIDED|95.0|0.558|0.867|||Stratified log rank|Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||0.867|0.558|0.0012
71030539|NCT00154102|141569037|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.171||||0.2648|TWO_SIDED|95.0|0.887|1.544|||Stratified log rank|Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||1.544|0.887|0.2648
71030540|NCT00154102|141569038|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.878||||0.0419|TWO_SIDED|95.0|0.774|0.995|||Stratified log rank|Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||0.995|0.774|0.0419
71030541|NCT00154102|141569039|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.796||||0.0093|TWO_SIDED|95.0|0.67|0.946|||Stratified log rank|Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||0.946|0.670|0.0093
71030542|NCT00154102|141569040|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.035||||0.7549|TWO_SIDED|95.0|0.834|1.284|||Stratified log rank|Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||1.284|0.834|0.7549
71030543|NCT00154102|141569041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.0038|TWO_SIDED|95.0|1.12|1.77|||Stratified cochran-mantel haenszel test|||The two-sided stratified Cochran-Mantel-Haenszel (CMH) test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||1.77|1.12|0.0038
71030544|NCT00154102|141569042|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.069|||<|0.0001|TWO_SIDED|95.0|1.515|2.826|||Cochran-Mantel-Haenszel|||The two-sided stratified Cochran-Mantel-Haenszel (CMH) test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||2.826|1.515|<0.0001
71030545|NCT00154102|141569043|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.822||||0.3475|TWO_SIDED|95.0|0.544|1.242|||Cochran-Mantel-Haenszel|||The two-sided stratified Cochran-Mantel-Haenszel (CMH) test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||1.242|0.544|0.3475
71030546|NCT00154102|141569044|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.6004|TWO_SIDED|95.0|0.67|1.26|||Stratified cochran-mantel haenszel test|||The two-sided stratified Cochran-Mantel-Haenszel (CMH) test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||1.26|0.67|0.6004
71030547|NCT00154102|141569046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.02||||0.002|TWO_SIDED|95.0|1.45|6.27|||Cochran-Mantel-Haenszel|||||6.27|1.45|0.002
70907261|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.293||0.7617|TWO_SIDED|95.0|-0.67|0.49|||MMRM|||Anxiety Psychic, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.49|-0.67|0.7617
71030548|NCT01297348|141569116|SUPERIORITY_OR_OTHER||Incidence rate ratio|2.01|||||TWO_SIDED|95.0|1.23|3.29||||||Incidence rate ratio (Lybrel/EE-20) along with corresponding 95 percent (%) confidence interval (CI) was reported for current users.||3.29|1.23|
71030549|NCT01297348|141569116|SUPERIORITY_OR_OTHER||Incidence rate ratio|2.99|||||TWO_SIDED|95.0|0.39|22.8||||||Incidence rate ratio (Lybrel/EE-20) along with corresponding 95% CI was reported for past users.||22.80|0.39|
71030550|NCT01297348|141569116|SUPERIORITY_OR_OTHER||Incidence rate ratio|3.49|||||TWO_SIDED|95.0|2.02|6.02||||||Incidence rate ratio (Lybrel/Levo-20) along with corresponding 95% CI was reported for current users.||6.02|2.02|
71030551|NCT01297348|141569116|SUPERIORITY_OR_OTHER||Incidence rate ratio|3.07|||||TWO_SIDED|95.0|0.34|27.47||||||Incidence rate ratio (Lybrel/Levo-20) along with corresponding 95% CI was reported for past users.||27.47|0.34|
71030552|NCT01297348|141569117|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51|||||TWO_SIDED|95.0|0.85|2.67||||||Current user, case and matched control: Odds ratio (Lybrel/EE-20) and 95% CI were estimated using conditional logistic regression, conditional on matching factors (age, calendar time, exposure status and database).||2.67|0.85|
71030553|NCT01297348|141569117|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.53|||||TWO_SIDED|95.0|0.98|6.54||||||Current user, case and matched control: Odds ratio (Lybrel/Levo-20) and 95% CI were estimated using conditional logistic regression, conditional on matching factors (age, calendar time, exposure status and database).||6.54|0.98|
71030554|NCT02334722|141569121|SUPERIORITY||Median Difference (Final Values)|-2.5||||0.7824|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.7824
71030555|NCT00686959|141569172|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.831|TWO_SIDED|95.0|0.79|1.2|||Log Rank|||||1.20|0.79|0.831
71030556|NCT00686959|141569173|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.13|TWO_SIDED|95.0|0.71|1.04|||Log Rank|||||1.04|0.71|0.130
71030557|NCT00686959|141569174|SUPERIORITY_OR_OTHER|||||||0.458|TWO_SIDED||||||Log Rank|||||||0.458
71030558|NCT00686959|141569177|SUPERIORITY_OR_OTHER|||||||0.132|TWO_SIDED||||||Fisher Exact|||Relapsed within the radiation treatment field||||0.132
71030559|NCT00686959|141569177|SUPERIORITY_OR_OTHER|||||||0.337|TWO_SIDED||||||Fisher Exact|||Relapsed inside thorax, outside of radiation field||||0.337
71030560|NCT00686959|141569177|SUPERIORITY_OR_OTHER|||||||0.457|TWO_SIDED||||||Fisher Exact|||Relapsed distant disease||||0.457
71030561|NCT00686959|141569178|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Fisher Exact|||||||0.150
71030562|NCT01212874|141569188|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||||||0.21
71102634|NCT04875533|141713841|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|2.13|||||TWO_SIDED|95.0|1.72|2.64||||||Serotype 15B: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||2.64|1.72|
71030563|NCT01212874|141569189|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
71030564|NCT03603314|141569204|SUPERIORITY|||||||0.3419|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.3419
71030565|NCT03603314|141569204|SUPERIORITY|||||||0.5181|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.5181
71030566|NCT03603314|141569205|SUPERIORITY|||||||0.3666|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.3666
71030567|NCT03603314|141569205|SUPERIORITY|||||||0.5776|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.5776
71030568|NCT03603314|141569206|SUPERIORITY|||||||0.4094|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.4094
71030569|NCT03603314|141569206|SUPERIORITY|||||||0.4602|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.4602
71030570|NCT03603314|141569207|SUPERIORITY|||||||0.1269|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.1269
71030571|NCT03603314|141569207|SUPERIORITY|||||||0.2257|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.2257
71030572|NCT03603314|141569208|SUPERIORITY|||||||0.3121|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.3121
71030573|NCT03603314|141569208|SUPERIORITY|||||||0.4965|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.4965
71102635|NCT04875533|141713841|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|1.62|||||TWO_SIDED|95.0|1.33|1.98||||||Serotype 22F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||1.98|1.33|
71090946|NCT05233761|141688244|SUPERIORITY|The mean nightly difference in Awake Time (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|2.4||0.3|TWO_SIDED|95.0|-2.4|6.9|||t-test, 2 sided|||The null hypothesis was that there was no difference in Awake Time (min) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||6.9|-2.4|0.3
71090947|NCT05233761|141688244|SUPERIORITY|The mean nightly difference in Total Sleep Time (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|4.7||0.14|TWO_SIDED|95.0|-16.1|2.4|||t-test, 2 sided|||The null hypothesis was that there was no difference in Total Sleep Time (min) sleep in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||2.4|-16.1|0.14
71090948|NCT05233761|141688245|SUPERIORITY|"The mean nightly difference in the perception of better sleep in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment differences was estimated and constructed using the above-mentioned method."|Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.5||0.53|TWO_SIDED|95.0|-0.7|1.3|||t-test, 2 sided|||"The null hypothesis was that there was no difference in the perception of better sleep in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups."||1.3|-.7|0.53
71090949|NCT05233761|141688245|SUPERIORITY|"The mean nightly difference in the perception of sleep induction in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment differences was estimated and constructed using the above-mentioned method."|Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.6||0.32|TWO_SIDED|95.0|-0.6|1.7|||t-test, 2 sided|||"The null hypothesis was that there was no difference in the perception of sleep induction in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups."||1.7|-0.6|0.32
71090950|NCT05233761|141688245|SUPERIORITY|"The mean nightly difference in the perception of sleep duration in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment differences was estimated and constructed using the above-mentioned method."|Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.6||0.2|TWO_SIDED|95.0|-0.4|1.9|||t-test, 2 sided|||"The null hypothesis was that there was no difference in the perception of sleep duration in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups."||1.9|-0.4|0.20
71090951|NCT05233761|141688245|SUPERIORITY|"The mean nightly difference in the perception of sleep depth in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment differences was estimated and constructed using the above-mentioned method."|Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.6||0.45|TWO_SIDED|95.0|-0.7|1.6|||t-test, 2 sided|||"The null hypothesis was that there was no difference in the perception of sleep depth in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups."||1.6|-0.7|0.45
71090952|NCT05233761|141688245|SUPERIORITY|"The mean nightly difference in the perception of vivid dreams in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment differences was estimated and constructed using the above-mentioned method."|Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.7||0.4|TWO_SIDED|95.0|-0.8|1.9|||t-test, 2 sided|||"The null hypothesis was that there was no difference in the perception of vivid dreams in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups."||1.9|-0.8|0.4
71090953|NCT00560404|141688263|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean Hb within target range during efficacy evaluation period within plus or minus 1 g/dL of their reference Hb and between the target range with a non-inferiority limit of -0.15.|Difference of response rates|-0.02|||||TWO_SIDED|95.0|-0.25|0.2||||||||0.20|-0.25|
71090954|NCT00392223|141688289|NON_INFERIORITY_OR_EQUIVALENCE|Analysis performed to assess non-inferiority by calculation \& examination of 95% CI. Analysis conducted via analysis of covariance (ANCOVA) including corresponding baseline value and centre as covariates. Non-inferiority margin was chosen as largest clinically acceptable difference. This was set as difference of 3 in GAGS global score. Azithromycin declared non-inferior to minocycline when two-sided 95% confidence interval for difference lied entirely to right of non-inferiority margin.|Mean Difference (Final Values)|-0.47||||||95.0|-2.48|1.54|||||Comparison between treatment groups was performed using an analysis of covariance (ANCOVA) method, with treatment, center, and baseline value GAGS global score included as covariates.|||1.54|-2.48|
71090955|NCT00392223|141688293|NON_INFERIORITY_OR_EQUIVALENCE|Analysis performed to assess non-inferiority by calculation \& examination of 95% CI. Analysis conducted via analysis of covariance (ANCOVA) including corresponding baseline value and centre as covariates. Non-inferiority margin was chosen as largest clinically acceptable difference. This was set as difference of 3 in GAGS global score. Azithromycin declared non-inferior to minocycline when two-sided 95% confidence interval for difference lied entirely to right of non-inferiority margin.|Mean Difference (Final Values)|-0.87||||||95.0|-2.58|0.84|||||ANCOVA adjusted for baseline, center and treatment.|||0.84|-2.58|
71090956|NCT06119854|141688295|OTHER||Risk Ratio (RR)|1.207|||||TWO_SIDED|95.0|0.406|3.59|||||The CBT arm is the numerator and the standard arm is the denominator.|||3.590|0.406|
71090957|NCT06119854|141688295|OTHER||Risk Difference (RD)|0.003|||||TWO_SIDED|95.0|-0.013|0.018|||||RD was calculated as the risk in the CBT arm minus the risk in the standard arm.|||0.018|-0.013|
71090958|NCT06119854|141688295|OTHER||Risk Ratio (RR)|0.687|||||TWO_SIDED|95.0|0.194|2.436|||||The inoculation arm is the numerator and the standard arm is the denominator.|||2.436|0.194|
71090959|NCT06119854|141688295|OTHER||Risk Difference (RD)|-0.004|||||TWO_SIDED|95.0|-0.018|0.01|||||RD was calculated as the risk in the inoculation arm minus the risk in the standard arm.|||0.010|-0.018|
71090960|NCT06119854|141688296|OTHER||Risk Ratio (RR)|0.992|||||TWO_SIDED|95.0|0.785|1.253|||||The CBT arm is the numerator and the standard arm is the denominator.|||1.253|0.785|
71090961|NCT06119854|141688296|OTHER||Risk Difference (RD)|-0.003|||||TWO_SIDED|95.0|-0.063|0.058|||||RD was calculated as the risk in the CBT arm minus the risk in the standard arm.|||0.058|-0.063|
71090962|NCT06119854|141688296|OTHER||Risk Ratio (RR)|1.227|||||TWO_SIDED|95.0|0.981|1.534|||||The inoculation arm is the numerator and the standard arm is the denominator.|||1.534|0.981|
71090963|NCT06119854|141688296|OTHER||Risk Difference (RD)|0.07|||||TWO_SIDED|95.0|0.008|0.133|||||RD was calculated as the risk in the inoculation arm minus the risk in the standard arm.|||0.133|0.008|
71030574|NCT03603314|141569209|SUPERIORITY|||||||0.0976|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.0976
71090964|NCT06119854|141688297|OTHER||Risk Ratio (RR)|1.063|||||TWO_SIDED|95.0|0.74|1.527|||||CBT group represents the numerator and standard (conventional) represents the denominator|||1.527|0.740|
71090965|NCT06119854|141688297|OTHER||Risk Difference (RD)|0.008|||||TWO_SIDED|95.0|-0.037|0.053|||||RD was calculated as the risk in the CBT arm minus the risk in the standard arm|||0.053|-0.037|
71090966|NCT06119854|141688297|OTHER||Risk Ratio (RR)|1.262|||||TWO_SIDED|95.0|0.892|1.784|||||The inoculation arm is the numerator and the standard arm is the denominator.|||1.784|0.892|
71090967|NCT06119854|141688297|OTHER||Risk Difference (RD)|0.034|||||TWO_SIDED|95.0|-0.013|0.08|||||RD was calculated as the risk in the inoculation arm minus the risk in the standard arm.|||0.080|-0.013|
71090968|NCT06119854|141688298|OTHER||Risk Ratio (RR)|1.131|||||TWO_SIDED|95.0|0.911|1.406|||||CBT arm is the numerator and the standard arm is the denominator.|||1.406|0.911|
71090969|NCT06119854|141688298|OTHER||Risk Difference (RD)|0.045|||||TWO_SIDED|95.0|-0.019|0.109|||||RD was calculated as the risk in the CBT arm minus the risk in the standard arm.|||0.109|-0.019|
71090970|NCT06119854|141688298|OTHER||Risk Ratio (RR)|1.323|||||TWO_SIDED|95.0|1.074|1.631|||||the inoculation arm is the numerator and the standard arm is the denominator.|||1.631|1.074|
71090971|NCT06119854|141688298|OTHER||Risk Difference (RD)|0.111|||||TWO_SIDED|95.0|0.045|0.176|||||RD was calculated as the risk in the inoculation arm minus the risk in the standard arm.|||0.176|0.045|
71090972|NCT03104374|141688300|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|32.8|||<|0.0001|TWO_SIDED|95.0|24.0|41.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||41.6|24.0|<0.0001
71090973|NCT03104374|141688300|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|39.7|||<|0.0001|TWO_SIDED|95.0|31.1|48.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||48.3|31.1|<0.0001
71090974|NCT03104374|141688301|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Least Squares (LS) Mean Difference|-0.21|||<|0.0001|TWO_SIDED|95.0|-0.3|-0.12|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-0.12|-0.30|<0.0001
71090975|NCT03104374|141688301|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.31|||<|0.0001|TWO_SIDED|95.0|-0.4|-0.22|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-0.22|-0.40|<0.0001
71090976|NCT03104374|141688302|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|27.6|||<|0.0001|TWO_SIDED|95.0|19.2|36.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||36.1|19.2|<0.0001
71090977|NCT03104374|141688302|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|31.0|||<|0.0001|TWO_SIDED|95.0|22.3|39.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||39.8|22.3|<0.0001
71030575|NCT03603314|141569209|SUPERIORITY|||||||0.1762|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.1762
71030576|NCT00615069|141569233|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|95.0|||||Log Rank|||Log-rank test of freedom from major adverse events through 1 year, 31 mm GORE EXCLUDER® Test Subjects vs historical open surgical control Subjects.||||0.003
71030577|NCT00615069|141569234|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.241|||||TWO_SIDED|95.0|0.428|3.603||||||Estimation of Hazard ratio of the 31 mm GORE EXCLUDER® Test Subjects vs original GORE EXCLUDER® AAA Endoprosthesis Subjects (original PMA subjects) using Cox Regression, not a powered analysis.||3.603|0.428|
71030578|NCT00259012|141569265|SUPERIORITY_OR_OTHER|||||||0.087|||||||t-test, 2 sided|paired||Within group comparison between steady state and baseline||||0.087
71030579|NCT00259012|141569265|SUPERIORITY_OR_OTHER|||||||0.019|||||||t-test, 2 sided|paired||Within group comparison between steady state and baseline||||0.019
71030580|NCT00259012|141569266|SUPERIORITY_OR_OTHER|||||||0.255|||||||t-test, 2 sided|paired||Within group comparison between steady state and baseline||||0.255
71030581|NCT00259012|141569266|SUPERIORITY_OR_OTHER|||||||0.031|||||||t-test, 2 sided|paired||Within group comparison between steady state and baseline.||||0.031
71030582|NCT00259012|141569267|SUPERIORITY_OR_OTHER|||||||0.099|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.099
71030583|NCT00259012|141569267|SUPERIORITY_OR_OTHER|||||||0.016|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.016
71030584|NCT00259012|141569268|SUPERIORITY_OR_OTHER|||||||0.347|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.347
71030585|NCT00259012|141569268|SUPERIORITY_OR_OTHER|||||||0.012|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.012
71030586|NCT00259012|141569269|SUPERIORITY_OR_OTHER|||||||0.339|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.339
71030587|NCT00259012|141569269|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.003
71030588|NCT00259012|141569270|SUPERIORITY_OR_OTHER|||||||0.982|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.982
71030589|NCT00259012|141569270|SUPERIORITY_OR_OTHER|||||||0.534|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.534
71030590|NCT00259012|141569271|SUPERIORITY_OR_OTHER|||||||0.166|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.166
71030591|NCT00259012|141569271|SUPERIORITY_OR_OTHER|||||||0.119|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.119
71030592|NCT00259012|141569272|SUPERIORITY_OR_OTHER|||||||0.387|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.387
71030593|NCT00259012|141569272|SUPERIORITY_OR_OTHER|||||||0.021|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.021
71030594|NCT04625114|141569335|SUPERIORITY||Mean Difference (Final Values)|1.183||||0.511|TWO_SIDED||||||Mixed Models Analysis|||||||0.511
71030595|NCT04625114|141569336|SUPERIORITY||Cox Proportional Hazard|0.965||||0.921|TWO_SIDED|95.0|0.48|1.942|||Regression, Cox|||||1.942|0.480|0.921
71030596|NCT03221374|141569338|OTHER|Linear mixed effect model to test the overall BCI learning between MBSR and control groups||||||0.003||||||The threshold for statistical analysis was p = 0.05.|Mixed Models Analysis|||||||0.003
71030597|NCT03221374|141569338|EQUIVALENCE|This independent t-test will test if the two groups (MBSR, control) exhibit a statistically significant difference in terms of BCI performance from baseline.|Mean Difference (Net)|8.98||||0.024|TWO_SIDED|||||The threshold for statistical analysis was p = 0.05|t-test, 2 sided||The difference between BCI performance improvement in MBSR cohort and control cohort.|||||0.024
71030598|NCT03221374|141569339|EQUIVALENCE|This WRS test will determine if the MBSR group breath counting accuracy was significantly greater than the postintervention levels of controls.|Mean Difference (Net)|15.4|||<|0.001|TWO_SIDED|||||The threshold for statistical analysis was p = 0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
71030599|NCT03221374|141569340|EQUIVALENCE|The null hypothesis is that the FMI scores of the two groups have equal medians.|Mean Difference (Final Values)|7.9|||<|0.01|TWO_SIDED|||||significant if p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.01
71030600|NCT03221374|141569340|EQUIVALENCE|The null hypothesis is that the MAAS scores of the two groups have equal medians.|Mean Difference (Final Values)|0.69|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71030601|NCT03221374|141569340|OTHER|This statistical test is about the correlation between baseline up-down BCI performance and the FMI score. A linear regression model is used to test if the slope is non-zero.|correlation coefficient|0.42|||<|0.05|TWO_SIDED|||||significant if p\<0.05|Regression, Linear|||||||<0.05
71030602|NCT03221374|141569340|OTHER|This statistical test is about the correlation between baseline up-down BCI performance and the MAAS score. A linear regression model is used to test if the slope is non-zero.|correlation coefficient|0.41|||<|0.05|TWO_SIDED||||||Regression, Linear|||||||<0.05
71030603|NCT02567968|141569341|SUPERIORITY|||||||0.002|||||||paired t-test|||||||0.002
71030604|NCT00336479|141569350|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.985||||0.0014|TWO_SIDED|95.0|1.525|5.842|||Regression, Logistic|Treatment, weight, race and baseline HCV RNA as factors||||5.842|1.525|0.0014
71030605|NCT00336479|141569350|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.0204|TWO_SIDED|95.0|1.127|4.178|||Regression, Logistic|||||4.178|1.127|0.0204
71030606|NCT00336479|141569351|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.586||||0.0051|TWO_SIDED|95.0|1.331|5.025|||Regression, Logistic|||||5.025|1.331|0.0051
71090978|NCT03104374|141688303|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|36.3|||<|0.0001|TWO_SIDED|95.0|25.6|46.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||46.9|25.6|<0.0001
71090979|NCT03104374|141688303|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|40.5|||<|0.0001|TWO_SIDED|95.0|29.9|51.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||51.0|29.9|<0.0001
71090980|NCT03104374|141688304|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|3.52|||<|0.0001|TWO_SIDED|95.0|2.07|4.98|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||4.98|2.07|<0.0001
71090981|NCT03104374|141688304|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|5.44|||<|0.0001|TWO_SIDED|95.0|3.99|6.88|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||6.88|3.99|<0.0001
71090982|NCT03104374|141688305|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|3.7|||<|0.0001|TWO_SIDED|95.0|2.0|5.4|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||5.4|2.0|<0.0001
71090983|NCT03104374|141688305|SUPERIORITY||LS Mean Difference|4.8|||<|0.0001|TWO_SIDED|95.0|3.1|6.4|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.||6.4|3.1|<0.0001
71090984|NCT03104374|141688306|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|22.3|||<|0.0001|TWO_SIDED|95.0|16.0|28.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||28.6|16.0|<0.0001
71090985|NCT03104374|141688306|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|26.1|||<|0.0001|TWO_SIDED|95.0|19.7|32.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||32.5|19.7|<0.0001
71090986|NCT03104374|141688307|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-22.9|||<|0.0001|TWO_SIDED|95.0|-27.4|-18.4|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-18.4|-27.4|<0.0001
71090987|NCT03104374|141688307|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-28.2|||<|0.0001|TWO_SIDED|95.0|-32.7|-23.8|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-23.8|-32.7|<0.0001
71090988|NCT03104374|141688308|SUPERIORITY||Response Rate Difference|27.0|||<|0.0001|TWO_SIDED|95.0|20.1|33.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||33.9|20.1|<0.0001
71090989|NCT03104374|141688308|SUPERIORITY||Response Rate Difference|32.9|||<|0.0001|TWO_SIDED|95.0|25.9|39.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||39.9|25.9|<0.0001
71090990|NCT03104374|141688309|SUPERIORITY||Response Rate Difference|8.1|||<|0.0001|TWO_SIDED|95.0|4.2|11.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||11.9|4.2|<0.0001
71090991|NCT03104374|141688309|SUPERIORITY||Response Rate Difference|16.0|||<|0.0001|TWO_SIDED|95.0|11.0|21.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||21.1|11.0|<0.0001
71090992|NCT03104374|141688310|SUPERIORITY||Response Rate Difference|21.9|||<|0.0001|TWO_SIDED|95.0|14.3|29.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||29.4|14.3|<0.0001
71090993|NCT03104374|141688310|SUPERIORITY||Response Rate Difference|22.6|||<|0.0001|TWO_SIDED|95.0|15.1|30.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||30.2|15.1|<0.0001
71090994|NCT03729362|141688337|SUPERIORITY|Analysis used a mixed-effect model for repeated measures (MMRM). The model included terms for treatment, baseline 6MWD, age, height, weight (all as continuous covariates), enzyme replacement therapy (ERT) status (ERT-naïve versus ERT-experienced), gender, time, and treatment-by-time interaction. Time was used as a repeated measure, and an unstructured covariance approach was applied.|LS Mean Difference|14.21|STANDARD_ERROR_OF_MEAN|8.481||0.048|TWO_SIDED|95.0|-2.6|31.02||1-sided significance level of 0.025.|MMRM|||"The primary and key secondary endpoints were tested in hierarchical order as follows:~The test for the primary endpoint was conducted first at the 1-sided 0.025 significance level, and if significant, the ordered key secondary endpoints were similarly tested. If at any point the null hypothesis for superiority failed to be rejected, then that comparison and any other comparison below it could not be claimed as successful and would be considered nominal."||31.02|-2.6|0.048
71090995|NCT03729362|141688338|SUPERIORITY|The analysis used an Analysis of Covariance (ANCOVA) model adjusted for the baseline value (as a continuous covariate) and ERT status (ERT-naïve versus ERT-experienced), as well as baseline age, gender, baseline height, and baseline weight.|LS Mean Difference|2.66|STANDARD_ERROR_OF_MEAN|1.156||0.012|TWO_SIDED|95.0|0.37|4.95||1-sided significance level of 0.025.|ANCOVA|||Change from baseline to Week 52 in sitting FVC was the first of 6 key secondary efficacy endpoints, which were analyzed according to a hierarchical order.||4.95|0.37|0.012
71090996|NCT03729362|141688339|SUPERIORITY|The analysis used an ANCOVA model adjusted for the baseline value (as a continuous covariate) and ERT status (ERT-naïve versus ERT-experienced), as well as baseline age, gender, baseline height, and baseline weight.|LS Mean Difference|0.96|STANDARD_ERROR_OF_MEAN|0.727||0.095|TWO_SIDED|95.0|-0.48|2.4||1-sided significance level of 0.025.|ANCOVA|||Change from baseline to Week 52 in the MMT score for the lower extremities was the second of 6 key secondary efficacy endpoints, which were analyzed according to a hierarchical order.||2.4|-0.48|0.095
71090997|NCT03729362|141688340|SUPERIORITY|The analysis used an ANCOVA model adjusted for the baseline value (as a continuous covariate) and ERT status (ERT-naïve versus ERT-experienced), as well as baseline age, gender, baseline height, and baseline weight.|LS Mean Difference|8.17|STANDARD_ERROR_OF_MEAN|6.261||0.097|TWO_SIDED|95.0|-4.24|20.57||1-sided significance level of 0.025.|ANCOVA|||Change from baseline to Week 26 in 6MWD was the third of 6 key secondary efficacy endpoints, which were analyzed according to a hierarchical order.||20.57|-4.24|0.097
71090998|NCT03729362|141688341|SUPERIORITY|The analysis used an ANCOVA model adjusted for the baseline value (as a continuous covariate) and ERT status (ERT-naïve versus ERT-experienced), as well as baseline age, gender, baseline height, and baseline weight.|LS Mean Difference|1.87|STANDARD_ERROR_OF_MEAN|1.706||0.138|TWO_SIDED|95.0|-1.51|5.25||1-sided significance level of 0.025|ANCOVA|||Change from baseline to Week 52 in the total score for the PROMIS® - Physical Function was the fourth of 6 key secondary efficacy endpoints, which were analyzed according to a hierarchical order.||5.25|-1.51|0.138
71090999|NCT03729362|141688342|SUPERIORITY|The analysis used an ANCOVA model adjusted for the baseline value (as a continuous covariate) and ERT status (ERT-naïve versus ERT-experienced), as well as baseline age, gender, baseline height, and baseline weight.|LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|1.092||0.515|TWO_SIDED|95.0|-2.12|2.2||1-sided significance level of 0.025|ANCOVA|||Change from baseline to Week 52 in the total score for the PROMIS® - Fatigue was the fifth of 6 key secondary efficacy endpoints, which were analyzed according to a hierarchical order.||2.2|-2.12|0.515
71091000|NCT03729362|141688343|SUPERIORITY|The analysis used an ANCOVA model adjusted for the baseline value (as a continuous covariate) and ERT status (ERT-naïve versus ERT-experienced), as well as baseline age, gender, baseline height, and baseline weight.|LS Mean Difference|-1.414|STANDARD_ERROR_OF_MEAN|0.528||0.004|TWO_SIDED|95.0|-2.463|-0.364||1-sided significance level of 0.025.|ANCOVA|||Change from baseline to Week 52 in the total score for the GSGC was the sixth of 6 key secondary efficacy endpoints, which were analyzed according to a hierarchical order.||-0.364|-2.463|0.004
71091001|NCT00576758|141688391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.26||||0.1587|TWO_SIDED|60.0|3.9|18.7|||Chi-squared|||||18.7|3.9|0.1587
71091002|NCT00576758|141688392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.83|||||TWO_SIDED|95.0|-2.9|16.6||||||||16.6|-2.9|
71091003|NCT00576758|141688396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22|||||TWO_SIDED|95.0|-13.9|18.3||||||||18.3|-13.9|
71091004|NCT00576758|141688397|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.62|1.44||||||||1.44|0.62|
71091005|NCT00576758|141688399|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.67|1.5||||||||1.50|0.67|
71091006|NCT00853385|141688449|SUPERIORITY_OR_OTHER||Percent difference|24.24|||<|0.0001|TWO_SIDED|95.0|13.18|35.31||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 10 mg to placebo and 2-sided 95% confidence interval (CI) was evaluated for the difference in percentages.||35.31|13.18|<0.0001
71091007|NCT00853385|141688449|SUPERIORITY_OR_OTHER||Percent difference|23.22|||<|0.0001|TWO_SIDED|95.0|12.16|34.29||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||34.29|12.16|<0.0001
71030607|NCT00336479|141569351|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.976||||0.0418|TWO_SIDED|95.0|1.026|3.807|||Regression, Logistic|||||3.807|1.026|0.0418
71030608|NCT01395030|141569365|OTHER||||||||||||||||||"Analysis was performed using Gene Set Enrichment Analysis (GSEA version 19.0.24, Broad Institute, Cambridge, MA) implemented in GenePattern (Broad Institute, Cambridge, MA) by uploading expression array data to this cloud-computing genomics platform. The specific details of this statistical approach can be found in the following publicly available references:~Reich M, Liefeld T, Gould J, Lerner J, Tamayo P, Mesirov JP. GenePattern 2.0 Nature Genetics 38 no. 5 (2006): pp500-501~Subramanian A, Tamayo P, Mootha VK, Mukherjee S, Ebert BL, Gillette MA, Paulovich A, Pomeroy SL, Golub TR, Lander ES, Mesirov JP. Gene set enrichment analysis: A knowledge-based approach for interpreting genome-wide expression profiles. PNAS. 2005;102(43);15545-15550."|||
71030609|NCT02079766|141569368|OTHER|||||||0.2959||||||No adjustments for multiple comparisons or multiplicity were made for this study. No a priori threshold for significance was chosen.|Fisher Exact|||Evaluated the association between the overall brain uptake and the study group||||0.2959
71030610|NCT02079766|141569369|OTHER|||||||0.5163||||||No adjustments for multiple comparisons or multiplicity were made for this study. No a priori threshold for significance was chosen.|ANOVA|MMSE score as the response variable and flortaucipir uptake score (4 levels) as the fixed effect||Measured differences in clinical presentation using MMSE between subjects with no visual flortaucipir uptake, and those with mild uptake.||||0.5163
71030611|NCT03117569|141569427|NON_INFERIORITY|A total of 375 participants (2:1 randomisation) were planned for enrolment and evaluation as ITT population. Under the assumption that SVR12 rate would be 96% in both arms, the study had 80% power to show non-inferiority of the simplified monitoring strategy with a lower confidence bound for SVR12 in the simplified monitoring arm greater than 90% or with a lower confidence bound for the difference (simplified arm minus standard arm) in SVR12 greater than -6%.|Difference in Percentage of Participants|-3.2|||<|0.05|TWO_SIDED|95.0|-8.2|1.8|||t-test, 2 sided|||||1.8|-8.2|<0.05
71030612|NCT02801877|141569450|SUPERIORITY|||||||0.3|||||||Log Rank|Chi square= 4.1 on 3 degrees of freedom||Log-rank test of adherence, defined as time to last engagement with mobile application suite.||||0.3
71030613|NCT02801877|141569451|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|F(3, 835)=0.19||Interactive effect of time and group, adjusting for baseline PHQ-9, randomization strata, main and interactive effects of time, coach, coach\*time, hub, and hub\*time.||||0.90
71030614|NCT02801877|141569452|SUPERIORITY|||||||0.53|||||||Mixed Models Analysis|F(3, 835)=0.73||Interactive effect of time and group, adjusting for baseline GAD-7, randomization strata, main and interactive effects of time, coach, coach\*time, hub, and hub\*time.||||0.53
71030615|NCT00420303|141569475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.47||||0.029||95.0|-32.93|-2.01|||ANCOVA|Treatment groups as fixed factors, baseline value as covariate||Comparison of adjusted means||-2.01|-32.93|0.029
71030616|NCT00420303|141569476|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.0||||0.02||95.0|1.44|69.26|||Generalized estimating equations (GEE)|Logit link, a binomial distribution and an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors.||||69.26|1.44|0.02
71030617|NCT00420303|141569477|SUPERIORITY_OR_OTHER|||||||0.007|||||||ANCOVA|Treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||||||0.007
71030618|NCT01029353|141569488|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.87|1.14|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis. Model included treatment, baseline risk of death or NDI, and pre-operative diagnosis (Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP)) as covariates.||1.14|0.87|
71030619|NCT01029353|141569488|OTHER|||||||0.03||||||Pre-specified threshold = 0.05|Robust Poisson regression|||A frequentist analysis. Using Robust Poisson regression with log link and center as repeated measure, and effect coding, test for an interaction between treatment (Initial Laparotomy/Initial Peritoneal Drain) and pre-operative diagnosis (Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP)) as covariates. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-operative diagnosis as covariates.||||0.03
71030620|NCT01029353|141569488|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.95, 95% credible interval of (0.82, 1.11).|||
71030621|NCT01029353|141569488|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.75|1.26|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariate.|A frequentist analysis. Model included treatment, baseline risk of death or NDI, and pre-operative diagnosis (Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP)) covariates.||1.26|0.75|
71030622|NCT01029353|141569489|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.69|1.45|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.45|0.69|
71091008|NCT00853385|141688449|SUPERIORITY_OR_OTHER||Percent difference|18.93||||0.0007|TWO_SIDED|95.0|7.9|29.96||Statistical testing was done at 5% significance level (2-sided).|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of adalimumab to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||29.96|7.90|0.0007
71091009|NCT00853385|141688450|SUPERIORITY_OR_OTHER||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.5|-0.25||A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo in ACR20 had to be significant.|Mixed Models Analysis|||Least squares (LS) mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.||-0.25|-0.50|<0.0001
71091010|NCT00853385|141688450|SUPERIORITY_OR_OTHER||LS mean difference|-0.31|||<|0.0001|TWO_SIDED|95.0|-0.43|-0.19||Step-down procedure: For the comparison of 5 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo as well as the comparison of 5 mg to placebo in ACR20 had to be statistically significant.|Mixed Models Analysis|||LS mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.||-0.19|-0.43|<0.0001
71091011|NCT00853385|141688450|SUPERIORITY_OR_OTHER||LS mean difference|-0.25|||<|0.0001|TWO_SIDED|95.0|-0.37|-0.13||Statistical testing was done at 5% significance level (2-sided).|Mixed Models Analysis|||LS mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.||-0.13|-0.37|<0.0001
71091012|NCT00853385|141688451|SUPERIORITY_OR_OTHER||Percent difference|11.41|||<|0.0001|TWO_SIDED|95.0|6.08|16.73||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in HAQ-DI had to be significant.|Normal approximation|||Normal approximation to the binomial distribution was used to test the superiority of CP-690,550 10 mg to placebo and two-sided 95% CI was evaluated for the difference in percentages.||16.73|6.08|<0.0001
71091013|NCT00853385|141688451|SUPERIORITY_OR_OTHER||Percent difference|5.12||||0.0151|TWO_SIDED|95.0|0.98|9.26||Step-down procedure: For the comparison of 5 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo as well as comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||9.26|0.98|0.0151
71091014|NCT00853385|141688451|SUPERIORITY_OR_OTHER||Percent difference|5.65||||0.0091|TWO_SIDED|95.0|1.4|9.9||Statistical testing was done at 5% significance level (2-sided).|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of adalimumab to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||9.90|1.40|0.0091
71091015|NCT01107015|141688539|OTHER|Sample size was determined on the basis of the primary outcome, change in glycated hemoglobin. The comparison of UC, which included 56 patients from nine practices, to CPDS, which included 62 patients from seven practices, had 80% power to detect a difference in mean glycated hemoglobin changes of 0.65 SD, corresponding to 1.0% if SD was 1.58%, using a two-sided test with 0.05 type I error after accounting for a within cluster correlation of 0.10.||||||0.027||||||CO (P = 0.027) and CPP (0.40) mean HbA1c levels decreased over 12 months.|Mixed Models Analysis|||Linear mixed-effects models were used to compare mean changes in primary and secondary outcomes between UC and each active intervention. The primary analysis examined 12-month changes for glycated hemoglobin. Secondary analyses jointly compared 3-, 6-, 9-, and 12-month changes between groups. Random effects accounted for within-practice clustering and within-patient correlation.||||0.027
71091016|NCT01107015|141688539|SUPERIORITY||Mean Difference (Net)|0.05||||0.001|TWO_SIDED||||||Mixed Models Analysis|||Linear mixed-effects models were used to compare mean changes in primary and secondary outcomes between UC and each active intervention. The primary analysis examined 12-month changes for glycated hemoglobin.||||0.001
71091017|NCT03104413|141688540|SUPERIORITY||Adjusted Risk Difference|22.1|||<|0.001|TWO_SIDED|95.0|13.1|31.0|||Cochran-Mantel-Haenszel|||||31.0|13.1|<0.001
71091018|NCT03104413|141688540|SUPERIORITY||Adjusted Risk Difference|20.5|||<|0.001|TWO_SIDED|95.0|11.6|29.5|||Cochran-Mantel-Haenszel|||||29.5|11.6|< 0.001
71091019|NCT03104413|141688541|SUPERIORITY||Adjusted Risk Difference|17.6|||<|0.001|TWO_SIDED|95.0|9.9|25.4|||Cochran-Mantel-Haenszel|||||25.4|9.9|< 0.001
71091020|NCT03104413|141688541|SUPERIORITY||Adjusted Risk Difference|23.1|||<|0.001|TWO_SIDED|95.0|15.1|31.1|||Cochran-Mantel-Haenszel|||||31.1|15.1|<0.001
71091021|NCT03104413|141688542|SUPERIORITY||Adjusted Risk Difference|17.6|||<|0.001|TWO_SIDED|95.0|9.9|25.4|||Cochran-Mantel-Haenszel|||||25.4|9.9|<0.001
71091022|NCT03104413|141688542|SUPERIORITY||Adjusted Risk Difference|23.1|||<|0.001|TWO_SIDED|95.0|15.1|31.1|||Cochran-Mantel-Haenszel|||||31.1|15.1|<0.001
71091023|NCT03104413|141688543|SUPERIORITY||Adjusted Risk Difference|15.2||||0.001|TWO_SIDED|95.0|6.4|24.0|||Cochran-Mantel-Haenszel|||||24.0|6.4|0.001
71091024|NCT03104413|141688543|SUPERIORITY||Adjusted Risk Difference|20.4|||<|0.001|TWO_SIDED|95.0|11.5|29.3|||Cochran-Mantel-Haenszel|||||29.3|11.5|<0.001
71091025|NCT03104413|141688544|SUPERIORITY||Adjusted Risk Difference|15.7||||0.001|TWO_SIDED|95.0|6.8|24.6|||Cochran-Mantel-Haenszel|||||24.6|6.8|0.001
71091026|NCT03104413|141688544|SUPERIORITY||Adjusted Risk Difference|11.8||||0.008|TWO_SIDED|95.0|3.0|20.5|||Cochran-Mantel-Haenszel|||||20.5|3.0|0.008
71091027|NCT03104413|141688545|SUPERIORITY||Adjusted Risk Difference|29.4|||<|0.001|TWO_SIDED|95.0|19.9|39.0|||Cochran-Mantel-Haenszel|||||39.0|19.9|< 0.001
71091028|NCT03104413|141688545|SUPERIORITY||Adjusted Risk Difference|30.6|||<|0.001|TWO_SIDED|95.0|21.1|40.1|||Cochran-Mantel-Haenszel|||||40.1|21.1|<0.001
71091029|NCT03104413|141688546|SUPERIORITY||LS Mean Difference|2.8||||0.02|TWO_SIDED|95.0|0.4|5.1|||Mixed-Effect Model Repeat Measurement|||||5.1|0.4|0.020
71091030|NCT03104413|141688546|SUPERIORITY||LS Mean Difference|3.0||||0.01|TWO_SIDED|95.0|0.7|5.3|||Mixed-Effect Model Repeat Measurement|||||5.3|0.7|0.010
71091031|NCT03104413|141688547|SUPERIORITY||Adjusted Risk Difference|9.6||||0.01|TWO_SIDED|95.0|2.3|16.9|||Cochran-Mantel-Haenszel|||||16.9|2.3|0.010
71091032|NCT03104413|141688547|SUPERIORITY||Adjusted Risk Difference|8.2||||0.023|TWO_SIDED|95.0|1.1|15.3|||Cochran-Mantel-Haenszel|||||15.3|1.1|0.023
71091033|NCT03104413|141688548|SUPERIORITY||Adjusted Risk Difference|15.0|||<|0.001|TWO_SIDED|95.0|8.5|21.5|||Cochran-Mantel-Haenszel|||||21.5|8.5|<0.001
71091034|NCT03104413|141688548|SUPERIORITY||Adjusted Risk Difference|17.8|||<|0.001|TWO_SIDED|95.0|11.1|24.5|||Cochran-Mantel-Haenszel|||||24.5|11.1|<0.001
71091035|NCT03104413|141688549|SUPERIORITY||Adjusted Risk Difference|17.5|||<|0.001|TWO_SIDED|95.0|8.0|26.9|||Cochran-Mantel-Haenszel|||||26.9|8.0|<0.001
71091036|NCT03104413|141688549|SUPERIORITY||Adjusted Risk Difference|20.3|||<|0.001|TWO_SIDED|95.0|10.8|29.8|||Cochran-Mantel-Haenszel|||||29.8|10.8|<0.001
71091037|NCT03104413|141688550|SUPERIORITY||Adjusted Risk Difference|21.8|||<|0.001|TWO_SIDED|95.0|12.1|31.6|||Cochran-Mantel-Haenszel|||||31.6|12.1|<0.001
71091038|NCT03104413|141688550|SUPERIORITY||Adjusted Risk Difference|22.7|||<|0.001|TWO_SIDED|95.0|13.0|32.5|||Cochran-Mantel-Haenszel|||||32.5|13.0|<0.001
71091039|NCT03104413|141688551|SUPERIORITY||Adjusted Risk Difference|15.0|||<|0.001|TWO_SIDED|95.0|8.9|21.2|||Cochran-Mantel-Haenszel|||||21.2|8.9|<0.001
71091040|NCT03104413|141688551|SUPERIORITY||Adjusted Risk Difference|16.2|||<|0.001|TWO_SIDED|95.0|9.9|22.4|||Cochran-Mantel-Haenszel|||||22.4|9.9|<0.001
71091041|NCT03104413|141688552|SUPERIORITY||Adjusted Risk Difference|13.6||||0.006|TWO_SIDED|95.0|4.0|23.3|||Cochran-Mantel-Haenszel|||||23.3|4.0|0.006
71091042|NCT03104413|141688552|SUPERIORITY||Adjusted Risk Difference|7.1||||0.142|TWO_SIDED|95.0|-2.4|16.6|||Cochran-Mantel-Haenszel|||||16.6|-2.4|0.142
71091043|NCT03104413|141688553|SUPERIORITY||Adjusted Risk Difference|9.4||||0.001|TWO_SIDED|95.0|3.8|15.1|||Cochran-Mantel-Haenszel|||||15.1|3.8|0.001
71091044|NCT03104413|141688553|SUPERIORITY||Adjusted Risk Difference|11.2|||<|0.001|TWO_SIDED|95.0|5.3|17.0|||Cochran-Mantel-Haenszel|||||17.0|5.3|<0.001
71091045|NCT03104413|141688554|SUPERIORITY||Adjusted Risk Difference|22.8|||<|0.001|TWO_SIDED|95.0|13.0|32.5|||Cochran-Mantel-Haenszel|||||32.5|13.0|<0.001
71091046|NCT03104413|141688554|SUPERIORITY||Adjusted Risk Difference|20.0|||<|0.001|TWO_SIDED|95.0|10.2|29.9|||Cochran-Mantel-Haenszel|||||29.9|10.2|<0.001
71091047|NCT03104413|141688555|SUPERIORITY||Adjusted Risk Difference|5.6||||0.377|TWO_SIDED|95.0|-6.8|17.9|||Cochran-Mantel-Haenszel|||||17.9|-6.8|0.377
71091048|NCT03104413|141688555|SUPERIORITY||Adjusted Risk Difference|13.4||||0.039|TWO_SIDED|95.0|0.7|26.1|||Cochran-Mantel-Haenszel|||||26.1|0.7|0.039
71091049|NCT03104413|141688556|SUPERIORITY||Risk Difference (RD)|-8.1||||0.002|TWO_SIDED|95.0|-13.2|-2.9|||Chi-squared|||||-2.9|-13.2|0.002
71091050|NCT03104413|141688556|SUPERIORITY||Risk Difference (RD)|-9.1|||<|0.001|TWO_SIDED|95.0|-14.1|-4.2|||Chi-squared|||||-4.2|-14.1|<0.001
71091051|NCT03104413|141688557|SUPERIORITY||Risk Difference (RD)|-6.2||||1|TWO_SIDED|95.0|-28.1|15.7|||Chi-squared|||||15.7|-28.1|1
71091052|NCT03104413|141688557|SUPERIORITY||Risk Difference (RD)|30.4||||0.113|TWO_SIDED|95.0|0.6|60.2|||Chi-squared|||||60.2|0.6|0.113
71091053|NCT03104413|141688558|SUPERIORITY||Adjusted Risk Difference|22.1|||<|0.001|TWO_SIDED|95.0|13.1|31.0|||Cochran-Mantel-Haenszel|||||31.0|13.1|<0.001
71091054|NCT03104413|141688558|SUPERIORITY||Adjusted Risk Difference|20.5|||<|0.001|TWO_SIDED|95.0|11.6|29.5|||Cochran-Mantel-Haenszel|||||29.5|11.6|<0.001
71091055|NCT03104413|141688559|SUPERIORITY||Adjusted Risk Difference|15.7||||0.001|TWO_SIDED|95.0|6.8|24.6|||Cochran-Mantel-Haenszel|||||24.6|6.8|0.001
71091056|NCT03104413|141688559|SUPERIORITY||Adjusted Risk Difference|11.8||||0.008|TWO_SIDED|95.0|3.0|20.5|||Cochran-Mantel-Haenszel|||||20.5|3|0.008
71091057|NCT03104413|141688560|SUPERIORITY||Adjusted Risk Difference|9.2||||0.006|TWO_SIDED|95.0|2.6|15.7|||Cochran-Mantel-Haenszel|||||15.7|2.6|0.006
71091058|NCT03104413|141688560|SUPERIORITY||Adjusted Risk Difference|10.3||||0.002|TWO_SIDED|95.0|3.7|16.8|||Cochran-Mantel-Haenszel|||||16.8|3.7|0.002
71091059|NCT03104413|141688561|SUPERIORITY||Adjusted Risk Difference|29.4|||<|0.001|TWO_SIDED|95.0|19.9|39.0|||Cochran-Mantel-Haenszel|||||39.0|19.9|<0.001
71091060|NCT03104413|141688561|SUPERIORITY||Adjusted Risk Difference|30.6|||<|0.001|TWO_SIDED|95.0|21.1|40.1|||Cochran-Mantel-Haenszel|||||40.1|21.1|<0.001
71091061|NCT03104413|141688562|SUPERIORITY||LS Mean Difference|2.8||||0.02|TWO_SIDED|95.0|0.4|5.1|||Mixed-Effect Model Repeat Measurement|||||5.1|0.4|0.020
71091062|NCT03104413|141688562|SUPERIORITY||LS Mean Difference|3.0||||0.01|TWO_SIDED|95.0|0.7|5.3|||Mixed-Effect Model Repeat Measurement|||||5.3|0.7|0.010
71091063|NCT03104413|141688563|SUPERIORITY||LS Mean Difference|12.4||||0.001|TWO_SIDED|95.0|5.0|19.8|||Mixed-Effect Model Repeat Measurement|||||19.8|5.0|0.001
71091064|NCT03104413|141688563|SUPERIORITY||LS Mean Difference|15.0|||<|0.001|TWO_SIDED|95.0|7.7|22.4|||Mixed-Effect Model Repeat Measurement|||||22.4|7.7|<0.001
71091065|NCT03104413|141688564|SUPERIORITY||Adjusted Risk Difference|13.9|||<|0.001|TWO_SIDED|95.0|7.1|20.7|||Cochran-Mantel-Haenszel|||||20.7|7.1|<0.001
71091066|NCT03104413|141688564|SUPERIORITY||Adjusted Risk Difference|17.3|||<|0.001|TWO_SIDED|95.0|10.3|24.2|||Cochran-Mantel-Haenszel|||||24.2|10.3|<0.001
71091067|NCT03104413|141688565|SUPERIORITY||Adjusted Risk Difference|15.0|||<|0.001|TWO_SIDED|95.0|8.9|21.2|||Cochran-Mantel-Haenszel|||||21.2|8.9|<0.001
71091068|NCT03104413|141688565|SUPERIORITY||Adjusted Risk Difference|16.2|||<|0.001|TWO_SIDED|95.0|9.9|22.4|||Cochran-Mantel-Haenszel|||||22.4|9.9|<0.001
71091069|NCT03104413|141688566|SUPERIORITY||Adjusted Risk Difference|13.6||||0.006|TWO_SIDED|95.0|4.0|23.3|||Cochran-Mantel-Haenszel|||||23.3|4|0.006
71091070|NCT03104413|141688566|SUPERIORITY||Adjusted Risk Difference|7.1||||0.142|TWO_SIDED|95.0|-2.4|16.6|||Cochran-Mantel-Haenszel|||||16.6|-2.4|0.142
71091071|NCT03104413|141688567|SUPERIORITY||Adjusted Risk Difference|9.4||||0.001|TWO_SIDED|95.0|3.8|15.1|||Cochran-Mantel-Haenszel|||||15.1|3.8|0.001
71091072|NCT03104413|141688567|SUPERIORITY||Adjusted Risk Difference|11.2|||<|0.001|TWO_SIDED|95.0|5.3|17.0|||Cochran-Mantel-Haenszel|||||17.0|5.3|<0.001
71091073|NCT03104413|141688568|SUPERIORITY||Adjusted Risk Difference|22.8|||<|0.001|TWO_SIDED|95.0|13.0|32.5|||Cochran-Mantel-Haenszel|||||32.5|13.0|<0.001
71091074|NCT03104413|141688568|SUPERIORITY||Adjusted Risk Difference|20.0|||<|0.001|TWO_SIDED|95.0|10.2|29.9|||Cochran-Mantel-Haenszel|||||29.9|10.2|<0.001
71091075|NCT03104413|141688569|SUPERIORITY||Adjusted Risk Difference|5.6||||0.377|TWO_SIDED|95.0|-6.8|17.9|||Cochran-Mantel-Haenszel|||||17.9|-6.8|0.377
71091076|NCT03104413|141688569|SUPERIORITY||Adjusted Risk Difference|13.4||||0.039|TWO_SIDED|95.0|0.7|26.1|||Cochran-Mantel-Haenszel|||||26.1|0.7|0.039
71091077|NCT03104413|141688570|SUPERIORITY||LS Mean Difference|-8.1||||0.002|TWO_SIDED|95.0|-13.2|-2.9|||Mixed-Effect Model Repeat Measurement|||||-2.9|-13.2|0.002
71091078|NCT03104413|141688570|SUPERIORITY||LS Mean Difference|-9.1|||<|0.001|TWO_SIDED|95.0|-14.1|-4.2|||Mixed-Effect Model Repeat Measurement|||||-4.2|-14.1|<0.001
71091079|NCT03104413|141688571|SUPERIORITY||LS Mean Difference|-6.2||||1|TWO_SIDED|95.0|-28.1|15.7|||Mixed-Effect Model Repeat Measurement|||||15.7|-28.1|1.00
71091080|NCT03104413|141688571|SUPERIORITY||LS Mean Difference|30.4||||0.113|TWO_SIDED|95.0|0.6|60.2|||Mixed-Effect Model Repeat Measurement|||||60.2|0.6|0.113
71091081|NCT03104413|141688572|SUPERIORITY||LS Mean Difference|-7.323||||0.113|TWO_SIDED|95.0|-16.399|1.753|||Mixed-Effect Model Repeat Measurement|||||1.753|-16.399|0.113
71091082|NCT03104413|141688572|SUPERIORITY||LS Mean Difference|-8.759||||0.05|TWO_SIDED|95.0|-17.518|-0.001|||Mixed-Effect Model Repeat Measurement|||||-0.001|-17.518|0.050
71091083|NCT03104413|141688573|SUPERIORITY||LS Mean Difference|2.221||||0.008|TWO_SIDED|95.0|0.577|3.865|||Mixed-Effect Model Repeat Measurement|||||3.865|0.577|0.008
71091084|NCT03104413|141688573|SUPERIORITY||LS Mean Difference|2.714||||0.001|TWO_SIDED|95.0|1.077|4.351|||Mixed-Effect Model Repeat Measurement|||||4.351|1.077|0.001
71091085|NCT03104413|141688574|SUPERIORITY||Adjusted Risk Difference|15.2||||0.001|TWO_SIDED|95.0|6.4|24.0|||Cochran-Mantel-Haenszel|||||24|6.4|0.001
71091086|NCT03104413|141688574|SUPERIORITY||Adjusted Risk Difference|20.4|||<|0.001|TWO_SIDED|95.0|11.5|29.3|||Cochran-Mantel-Haenszel|||||29.3|11.5|<0.001
71091087|NCT02765035|141688575|SUPERIORITY|||||||0.01|||||||t-test, 1 sided|||C-Leg 3 vs. NMPK (Baseline)||||0.01
71091088|NCT02765035|141688575|SUPERIORITY|||||||0.04|||||||t-test, 1 sided|||C-Leg 4 vs. NMPK (Baseline)||||0.04
71091089|NCT00984867|141688585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.072|<|0.0001|TWO_SIDED|95.0|-0.62|-0.34||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives, based on data from both strata combined|ANCOVA|with treatment group and stratum as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group||-0.34|-0.62|<0.0001
71091090|NCT00984867|141688586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.89|STANDARD_ERROR_OF_MEAN|0.2466|<|0.0001|TWO_SIDED|95.0|-2.37|-1.4||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group||-1.40|-2.37|<0.0001
71091091|NCT00984867|141688587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.1106|<|0.0001|TWO_SIDED|95.0|-1.05|-0.62||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group||-0.62|-1.05|<0.0001
71091092|NCT00984867|141688588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.92|STANDARD_ERROR_OF_MEAN|3.32|<|0.0001|TWO_SIDED|95.0|-34.45|-21.4||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group||-21.40|-34.45|<0.0001
71091093|NCT00984867|141688589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86|STANDARD_ERROR_OF_MEAN|1.4659||0.5583||95.0|-3.75|2.03||Not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group||2.03|-3.75|0.5583
71091094|NCT00984867|141688590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.82|STANDARD_ERROR_OF_MEAN|3.516|||TWO_SIDED|95.0|-21.73|-7.9||Not significant. Hierarchical testing procedure stopped at previous endpoint|ANCOVA|with treatment group and stratum as effect and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group||-7.90|-21.73|
71091095|NCT00984867|141688591|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.7|STANDARD_ERROR_OF_MEAN|41.2|||TWO_SIDED|95.0|11.1|26.4||Not significant. Hierarchical testing procedure stopped at previous endpoint|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value and stratum||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0.||26.4|11.1|
71091096|NCT01928849|141688642|OTHER||Odds Ratio (OR)|0.77||||0.53|TWO_SIDED|95.0|0.34|1.74|||Regression, Logistic|Univariable Logistic regression||||1.74|0.34|0.53
71091097|NCT01928849|141688643|OTHER|||||||0.95|||||||Chi-squared|||Comparison of rate of residual limb pain between treatment groups||||0.95
71091098|NCT01928849|141688643|OTHER|||||||0.74|||||||Chi-squared|||Comparison of rate of Phantom limb pain between treatment groups||||0.74
71091099|NCT01928849|141688644|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Comparison of opioid consumption postoperative hours 0-24||||0.27
71091100|NCT01928849|141688644|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Comparison of opioid consumption postoperative hours 24-48||||0.27
71091101|NCT01928849|141688645|OTHER|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||Comparison of BPI average pain score||||0.59
71091102|NCT01928849|141688645|OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Comparison of BPI Interference question sum||||0.16
71091103|NCT01928849|141688646|OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.35
71091104|NCT01928849|141688647|OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||Comparison of DVPRS numeric pain score||||0.42
71091105|NCT01928849|141688647|OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Comparison of DVPRS supplemental question sum||||0.19
71091106|NCT01928849|141688648|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Comparison of RASS postoperative hours 0-24||||0.27
71091107|NCT01928849|141688648|OTHER|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||Comparison of RASS postoperative hours 24-48||||0.26
71091108|NCT03185208|141688655|SUPERIORITY||treatment x time interaction coefficient|0.69||||0.048|TWO_SIDED||||||Mixed Models Analysis|||||||0.048
71091109|NCT03185208|141688656|SUPERIORITY||treatment x time interaction coefficient|-0.08835||||0.78|TWO_SIDED||||||Mixed Models Analysis|||||||0.78
71091110|NCT03185208|141688657|SUPERIORITY||treatment x time interaction coefficient|0.08738||||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||0.80
71091111|NCT03185208|141688659|SUPERIORITY||treatment x time interaction coefficient|0.012||||0.93|TWO_SIDED||||||Mixed Models Analysis|||||||0.93
71091112|NCT03185208|141688660|SUPERIORITY||treatment x time interaction coefficient|-351.8||||0.78|TWO_SIDED||||||Mixed Models Analysis|||||||0.78
71091113|NCT03185208|141688661|SUPERIORITY||treatment x time interaction coefficient|58.95||||0.087|TWO_SIDED||||||Mixed Models Analysis|||||||0.087
71091114|NCT01206764|141688685|OTHER|Kaplan Meier|Median Difference (Net)|27.71|||||TWO_SIDED|95.0|21.86|35.29||||||Single arm open label study||35.29|21.86|
71091115|NCT01206764|141688689|OTHER|Kaplan Meier|Median Difference (Net)|45.71|||||TWO_SIDED|95.0|31.29|106.43||||||The median overall survival was not evaluable, this presents the 25th percentile of overall survival||106.43|31.29|
71091116|NCT01186770|141688690|SUPERIORITY||Least square (LS) mean difference|2.83||||0.1692||95.0|-1.21|6.86||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) with treatment as effect and analysis region as covariate.||6.86|-1.21|0.1692
71091117|NCT01186770|141688690|SUPERIORITY||LS mean difference|6.51||||0.0016|TWO_SIDED|95.0|2.47|10.55||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using ANCOVA with treatment as effect and analysis region as covariate.||10.55|2.47|0.0016
71091118|NCT01186770|141688690|SUPERIORITY||LS mean difference|9.13|||<|0.0001|TWO_SIDED|95.0|5.09|13.18||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using ANCOVA with treatment as effect and analysis region as covariate.||13.18|5.09|< 0.0001
71091119|NCT01186770|141688691|SUPERIORITY||Odds Ratio (OR)|1.23||||0.3076|TWO_SIDED|95.0|0.82|1.84||Threshold for significance at 0.0167 level.|Regression, Logistic|||Analysis was performed using logistic regression model with treatment as effect and analysis region as covariate.||1.84|0.82|0.3076
71091120|NCT01186770|141688691|SUPERIORITY||Odds Ratio (OR)|1.54||||0.0339|TWO_SIDED|95.0|1.03|2.29||Threshold for significance at 0.0167 level.|Regression, Logistic|||Analysis was performed using logistic regression model with treatment as effect and analysis region as covariate.||2.29|1.03|0.0339
71091121|NCT01186770|141688691|SUPERIORITY||Odds Ratio (OR)|1.79||||0.0043||95.0|1.2|2.66||Threshold for significance at 0.0167 level.|Regression, Logistic|||Analysis was performed using logistic regression model with treatment as effect and analysis region as covariate.||2.66|1.20|0.0043
71091122|NCT01186770|141688692|SUPERIORITY||LS mean difference|0.09||||0.692|TWO_SIDED|95.0|-0.36|0.55||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using ANCOVA model with treatment as effect and analysis region and baseline as covariates.||0.55|-0.36|0.6920
71091123|NCT01186770|141688692|SUPERIORITY||LS mean difference|0.51||||0.0274|TWO_SIDED|95.0|0.06|0.97||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using ANCOVA model with treatment as effect and analysis region and baseline as covariates.||0.97|0.06|0.0274
71091124|NCT01186770|141688692|SUPERIORITY||LS mean difference|0.53||||0.0237|TWO_SIDED|95.0|0.07|0.98||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using ANCOVA model with treatment as effect and analysis region and baseline as covariates.||0.98|0.07|0.0237
71091125|NCT01033136|141688719|EQUIVALENCE|To test if MCET is equivalent to CPT in decreasing PTSD symptoms, we test the equivalence of the proportion of patients whose CAPS scores decrease by 10 from baseline, by testing whether the difference in proportions between the 2 interventions ≤ to the equivalence margin δb of .20. Results are reported based on 3-month follow-up data.||||||0.3||||||The threshold for statistical significance is p \<.05 and is not adjusted for multiple comparisons.|Fisher Exact|||||||0.30
71091126|NCT01033136|141688720|OTHER|||||||0.68||||||The threshold for statistical significance is p \<.05 and is not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom: 2, 54||Longitudinal analysis of PDSS scores||||0.68
71091127|NCT05824026|141688753|OTHER||||||||||||||||||"The purpose of the primary analysis was to show non-inferiority to the performance of a historical control (a silver containing gelling fiber) on proportion of wounds healed, 77%, with a non-inferiority margin of 20%. Non-inferiority was demonstrated if the lower limit of the 95% confidence interval is above 57%. An exact confidence interval for the proportion was applied. In the primary analysis missing data was not included. In the post hoc sensitivity analysis missing data was imputed using multiple imputation for 3 wounds where data was assumed to be missing at random, and otherwise imputed as wound not healed.~The supplemental analysis addressed a more conservative analysis than performed for the historical control. Hence, no formal non-inferiority criteria was applied for this analysis."|||
71091128|NCT02763566|141688774|SUPERIORITY||Hazard Ratio (HR)|0.499||||0.0001|TWO_SIDED|95.0|0.346|0.719|||Log Rank|||||0.719|0.346|0.0001
71091129|NCT02763566|141688775|SUPERIORITY||Hazard Ratio (HR)|0.376|||<|0.0001|TWO_SIDED|95.0|0.24|0.588|||Log Rank|||||0.588|0.240|<0.0001
71091130|NCT02763566|141688777|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71091131|NCT02763566|141688777|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71091132|NCT02763566|141688779|SUPERIORITY|||||||0.0456|||||||Cochran-Mantel-Haenszel|||||||0.0456
71030623|NCT01029353|141569489|SUPERIORITY|A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|||||||||||||||||Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.95, 95% credible interval of (0.69, 1.30).|||
71091133|NCT02763566|141688779|SUPERIORITY|||||||0.0004|||||||Cochran-Mantel-Haenszel|||||||0.0004
71091134|NCT02763566|141688780|SUPERIORITY|||||||0.0003|||||||Cochran-Mantel-Haenszel|||||||0.0003
71091135|NCT02763566|141688780|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71091136|NCT02763566|141688781|SUPERIORITY||LSMean Difference|-1.89|STANDARD_ERROR_OF_MEAN|1.77||0.287|TWO_SIDED|95.0|-5.36|1.59|||Mixed Models Analysis|||Global Health Status||1.59|-5.36|0.287
71091137|NCT02763566|141688781|SUPERIORITY||LSMean Difference|-0.77|STANDARD_ERROR_OF_MEAN|1.46||0.597|TWO_SIDED|95.0|-3.64|2.1|||Mixed Models Analysis|||Functional Scales - Physical functioning||2.10|-3.64|0.597
71091138|NCT02763566|141688781|SUPERIORITY||LSMean Difference|-0.31|STANDARD_ERROR_OF_MEAN|2.15||0.885|TWO_SIDED|95.0|-4.55|3.93|||Mixed Models Analysis|||Functional Scales - Role Functioning||3.93|-4.55|0.885
71091139|NCT02763566|141688781|SUPERIORITY||LSMean Difference|1.67|STANDARD_ERROR_OF_MEAN|1.74||0.34|TWO_SIDED|95.0|-1.77|5.1|||Mixed Models Analysis|||Functional Scales - Emotional Functioning||5.10|-1.77|0.340
71091140|NCT02763566|141688781|SUPERIORITY||LSMean Difference|-2.17|STANDARD_ERROR_OF_MEAN|1.62||0.182|TWO_SIDED|95.0|-5.37|1.03|||Mixed Models Analysis|||Functional Scales - Cognitive Functioning||1.03|-5.37|0.182
71091141|NCT02763566|141688781|SUPERIORITY||LSMean Difference|-0.88|STANDARD_ERROR_OF_MEAN|2.12||0.678|TWO_SIDED|95.0|-5.05|3.29|||Mixed Models Analysis|||||3.29|-5.05|0.678
71091142|NCT02763566|141688781|SUPERIORITY||LSMean Difference|1.57|STANDARD_ERROR_OF_MEAN|1.7||0.355|TWO_SIDED|95.0|-1.77|4.91|||Mixed Models Analysis|||Symptom Scales - Fatigue||4.91|-1.77|0.355
71091143|NCT02763566|141688781|SUPERIORITY||LSMean Difference|0.95|STANDARD_ERROR_OF_MEAN|1.06||0.372|TWO_SIDED|95.0|-1.14|3.03|||Mixed Models Analysis|||Symptom Scales - Nausea and Vomiting||3.03|-1.14|0.372
71091144|NCT02763566|141688781|SUPERIORITY||LSMean Difference|0.74|STANDARD_ERROR_OF_MEAN|1.63||0.74|TWO_SIDED|95.0|-3.75|2.66|||Mixed Models Analysis|||Symptom Scales - Pain||2.66|-3.75|0.740
71091145|NCT02763566|141688781|SUPERIORITY||LSMean Difference|2.16|STANDARD_ERROR_OF_MEAN|1.84||0.24|TWO_SIDED|95.0|-1.46|5.78|||Mixed Models Analysis|||Symptom Scales - Dyspnoea||5.78|-1.46|0.240
71091146|NCT02763566|141688781|SUPERIORITY||LSMean Difference|-0.81|STANDARD_ERROR_OF_MEAN|1.92||0.673|TWO_SIDED|95.0|-4.6|2.97|||Mixed Models Analysis|||Symptom scales - Insomnia||2.97|-4.60|0.673
71091147|NCT02763566|141688781|SUPERIORITY||LSMean Difference|5.65|STANDARD_ERROR_OF_MEAN|1.74||0.001|TWO_SIDED|95.0|2.23|9.07|||Mixed Models Analysis|||Symptom Scales - Appetite||9.07|2.23|0.001
71091148|NCT02763566|141688781|SUPERIORITY||LSMean Difference|-1.57|STANDARD_ERROR_OF_MEAN|1.76||0.375|TWO_SIDED|95.0|-5.04|1.91|||Mixed Models Analysis|||Symptom Scales - Constipation||1.91|-5.04|0.375
71091149|NCT02763566|141688781|SUPERIORITY||LSMean Difference|15.82|STANDARD_ERROR_OF_MEAN|1.53||0|TWO_SIDED|95.0|12.81|18.84|||Mixed Models Analysis|||Symptom Scales - Diarrhoea||18.84|12.81|0.000
71091150|NCT02763566|141688781|SUPERIORITY||LSMean Difference|-1.75|STANDARD_ERROR_OF_MEAN|2.97||0.557|TWO_SIDED|95.0|-7.59|4.1|||Mixed Models Analysis|||Symptom Scales - Financial Difficulties||4.10|-7.59|0.557
71091151|NCT02763566|141688781|SUPERIORITY||LSMean Difference|-3.47|STANDARD_ERROR_OF_MEAN|2.51||0.169|TWO_SIDED|95.0|-8.43|1.49|||Mixed Models Analysis|||Global Health Status||1.49|-8.43|0.169
71091152|NCT02763566|141688781|SUPERIORITY||LSMean Difference|1.58|STANDARD_ERROR_OF_MEAN|1.87||0.4|TWO_SIDED|95.0|-2.12|5.29|||Mixed Models Analysis|||Functional Scales - Physical Functioning||5.29|-2.12|0.400
71091153|NCT02763566|141688781|SUPERIORITY||LSMean Difference|-1.72|STANDARD_ERROR_OF_MEAN|2.38||0.472|TWO_SIDED|95.0|-6.42|2.99|||Mixed Models Analysis|||Functional Scales - Role functioning||2.99|-6.42|0.472
71091154|NCT02763566|141688781|SUPERIORITY||LSMean Difference|-2.42|STANDARD_ERROR_OF_MEAN|0.31||0.31|TWO_SIDED|95.0|-7.12|2.28|||Mixed Models Analysis|||Functional Scales - Emotional Functioning||2.28|-7.12|0.310
71091155|NCT02763566|141688781|SUPERIORITY||LSMean Difference|0.64|STANDARD_ERROR_OF_MEAN|2.98||0.83|TWO_SIDED|95.0|-5.26|6.55|||Mixed Models Analysis|||Functional Scales - Social Functioning||6.55|-5.26|0.830
71091156|NCT02763566|141688781|SUPERIORITY||LSMean Difference|2.73|STANDARD_ERROR_OF_MEAN|2.52||0.281|TWO_SIDED|95.0|-2.26|7.72|||Mixed Models Analysis|||Symptom Scales - Fatigue||7.72|-2.26|0.281
71091157|NCT02763566|141688781|SUPERIORITY||LSMean Difference|2.59|STANDARD_ERROR_OF_MEAN|1.99||0.194|TWO_SIDED|95.0|-1.33|6.52|||Mixed Models Analysis|||Symptom Scales - Nausea and Vomiting||6.52|-1.33|0.194
71091158|NCT02763566|141688781|SUPERIORITY||LSMean Difference|-2.66|STANDARD_ERROR_OF_MEAN|2.42||0.275|TWO_SIDED|95.0|-7.45|2.14|||Mixed Models Analysis|||Symptom Scales - Pain||2.14|-7.45|0.275
71091159|NCT02763566|141688781|SUPERIORITY||LSMean Difference|-2.49|STANDARD_ERROR_OF_MEAN|4.39||0.28|TWO_SIDED|95.0|-7.04|2.06|||Mixed Models Analysis|||Symptom Scales - Dyspnoea||2.06|-7.04|0.280
71091160|NCT02763566|141688781|SUPERIORITY||LSMean Difference|1.97|STANDARD_ERROR_OF_MEAN|2.9||0.499|TWO_SIDED|95.0|-3.78|7.72|||Mixed Models Analysis|||Symptom Scales - Insomnia||7.72|-3.78|0.499
71091161|NCT02763566|141688781|SUPERIORITY||LSMean Difference|7.46|STANDARD_ERROR_OF_MEAN|2.92||0.012|TWO_SIDED|95.0|1.68|13.23|||Mixed Models Analysis|||Symptom Scales - Appetite||13.23|1.68|0.012
71091162|NCT02763566|141688781|SUPERIORITY||LSMean Difference|-2.28|STANDARD_ERROR_OF_MEAN|2.29||0.321|TWO_SIDED|95.0|-6.83|2.27|||Mixed Models Analysis|||Symptom Scales - Constipation||2.27|-6.83|0.321
71091163|NCT02763566|141688781|SUPERIORITY||LSMean Difference|17.83|STANDARD_ERROR_OF_MEAN|2.32||0|TWO_SIDED|95.0|13.25|22.41|||Mixed Models Analysis|||Symptom Scales - Diarrhoea||22.41|13.25|0.000
71091164|NCT02763566|141688781|SUPERIORITY||LSMean Difference|2.99|STANDARD_ERROR_OF_MEAN|3.14||0.342|TWO_SIDED|95.0|-3.21|9.19|||Mixed Models Analysis|||Symptom Scales - Financial DIfficulties||9.19|-3.21|0.342
71091165|NCT02763566|141688781|SUPERIORITY||LSMean Difference|-2.42|STANDARD_ERROR_OF_MEAN|2.38||0.31|TWO_SIDED|95.0|-7.12|2.28|||Mixed Models Analysis|||Functional Scales - Cognitive functioning||2.28|-7.12|0.310
71091166|NCT02855268|141688784|SUPERIORITY||Least square mean difference|-0.22|STANDARD_ERROR_OF_MEAN|3.27||0.9472|TWO_SIDED|95.0|-6.92|6.48||Threshold of significance was 1-sided \<0.025.|Linear mixed effect model|||Annualized rate of change in eGFR during the placebo-controlled treatment period was compared between lademirsen and placebo using a random coefficient linear mixed effect model which included time as a continuous variable.||6.48|-6.92|0.9472
71091167|NCT00914069|141688811|SUPERIORITY_OR_OTHER|||||||0.05||||||Threshold for significance was p less than or equal to 0.05 by a one-tailed Fisher Exact Test.|Fisher Exact|||||||0.05
71091168|NCT00914069|141688814|SUPERIORITY_OR_OTHER|||||||0.8|||||||Fisher Exact|||||||0.8
71091169|NCT04513366|141688823|SUPERIORITY||Risk Difference (RD)|0.44|||<|0.0001|TWO_SIDED|97.5|0.23|0.64|||Mantel Haenszel|||||0.64|0.23|<.0001
71091170|NCT04513366|141688823|SUPERIORITY||Risk Difference (RD)|0.53|||<|0.0001|TWO_SIDED|97.5|0.32|0.73|||Mantel Haenszel|||||0.73|0.32|<.0001
71091171|NCT04513366|141688824|SUPERIORITY||Least Square (LS) Mean Difference|-5.3|||<|0.001|TWO_SIDED|97.5|-7.18|-3.42|||ANCOVA|||||-3.42|-7.18|<.001
71091172|NCT04513366|141688824|SUPERIORITY||LS Mean Difference|-5.6|||<|0.001|TWO_SIDED|97.5|-7.57|-3.7|||ANCOVA|||||-3.70|-7.57|<.001
71091173|NCT04513366|141688825|SUPERIORITY||LS Mean Difference|-64.3|||<|0.001|TWO_SIDED|97.5|-87.85|-40.85|||ANCOVA|||||-40.85|-87.85|<.001
71091174|NCT04513366|141688825|SUPERIORITY||LS Mean Difference|-69.8|||<|0.001|TWO_SIDED|97.5|-92.16|-47.35|||ANCOVA|||||-47.35|-92.16|<.001
71008430|NCT02364999|141524736|EQUIVALENCE|Calculated based on 2-sided Miettinen and Nurminen method without strata for risk difference for confirmed response. EU equivalence margins (95% CI in -13% to 13%).|Risk Difference (RD)|0.6531|||||TWO_SIDED|95.0|-6.608|7.9082|||||PF-06439535 vs Bevacizumab-EU|||7.9082|-6.6080|
71091175|NCT04513366|141688826|SUPERIORITY||LS Mean Difference|4.5|STANDARD_ERROR_OF_MEAN|2.6||0.09|TWO_SIDED||||||Mixed Models Analysis|||||||0.090
71091176|NCT04513366|141688826|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|2.5||0.472|TWO_SIDED||||||Mixed Models Analysis|||||||0.472
71091177|NCT04513366|141688827|SUPERIORITY||Difference|0.58||||0.0003|TWO_SIDED|97.5|0.25|0.91|||Chi-squared|||||0.91|0.25|0.0003
71091178|NCT04513366|141688827|SUPERIORITY||Difference|0.25||||0.1895|TWO_SIDED|97.5|-0.36|0.86|||Chi-squared|||||0.86|-0.36|0.1895
71091179|NCT04513366|141688828|SUPERIORITY||Difference|0.43||||0.0035|TWO_SIDED|97.5|0.14|0.72|||Chi-squared|||||0.72|0.14|0.0035
71091180|NCT04513366|141688828|SUPERIORITY||Difference|0.28||||0.0428|TWO_SIDED|97.5|-0.02|0.57|||Chi-squared|||||0.57|-0.02|0.0428
71091181|NCT04513366|141688829|SUPERIORITY||LS Mean Difference|-0.2||||0.517|TWO_SIDED|97.5|-1.1|0.61|||Mixed Models Analysis|||||0.61|-1.10|0.517
71091182|NCT04513366|141688829|SUPERIORITY||LS Mean Difference|0.4||||0.23|TWO_SIDED|97.5|-0.39|1.28|||Mixed Models Analysis|||||1.28|-0.39|0.230
71091183|NCT04513366|141688830|SUPERIORITY||LS Mean Difference|-0.1||||0.25|TWO_SIDED|97.5|-0.35|0.12|||Mixed Models Analysis|||||0.12|-0.35|0.250
71091184|NCT04513366|141688830|SUPERIORITY||LS Mean Difference|0.1||||0.506|TWO_SIDED|97.5|-0.16|0.29|||Mixed Models Analysis|||||0.29|-0.16|0.506
71091185|NCT04513366|141688831|SUPERIORITY||LS Mean Difference|-0.1||||0.653|TWO_SIDED|97.5|-0.55|0.37|||ANOVA|||||0.37|-0.55|0.653
71091186|NCT04513366|141688831|SUPERIORITY||LS Mean Difference|0.1||||0.629|TWO_SIDED|97.5|-0.36|0.56|||ANOVA|||||0.56|-0.36|0.629
71091187|NCT04513366|141688832|SUPERIORITY||LS Mean Difference|0.1||||0.731|TWO_SIDED|97.5|-0.4|0.54|||ANOVA|||Treatment Periods 1-3 (Months 1-3)||0.54|-0.40|0.731
71091188|NCT04513366|141688832|SUPERIORITY||LS Mean Difference|0.1||||0.583|TWO_SIDED|97.5|-0.35|0.58|||ANOVA|||Treatment Periods 1-3 (Month 1-3)||0.58|-0.35|0.583
71091189|NCT04478266|141688844|SUPERIORITY||Hazard Ratio (HR)|1.209||||0.9304|TWO_SIDED|95.0|0.939|1.557||One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.025 level.|Stratified Log-Rank test|Stratified on presence of De-novo metastatic disease, Postmenopausal women and Visceral metastasis according to IRT.|Letrozole + Palbociclib versus Amcenestrant + Palbociclib|A hierarchical testing procedure was used to ensure a strong control of the overall Type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at one-sided 2.5% for the primary and the first secondary outcome.||1.557|0.939|0.9304
71091190|NCT03114150|141688889|SUPERIORITY||Slope|-0.02|||<|0.05|TWO_SIDED|95.0|-0.04|0.01|||Mixed Models Analysis|Kenward-Roger adjustments for degrees of freedom|Parameter is the interaction term for the interaction of group, learning rate, and session.|We tested the prediction that learning rate would increase more so for the moderate-to-vigorous training group compared to the light intensity training group. This prediction was tested with a linear mixed model, according to our statistical analysis plan.||.01|-.04|<.05
71091191|NCT03114150|141688890|SUPERIORITY||Mean Difference (Final Values)|0.01|||<|0.05|TWO_SIDED|95.0|-0.01|0.02|||Mixed Models Analysis|Kenward-Roger adjustments for degrees of freedom|Parameter is the interaction term for the interaction of exercise condition (intensity) and session.|We tested the prediction that hippocampal-cortical functional connectivity would change more for the moderate-to-vigorous acute condition compared to the light intensity condition. This prediction was tested with a linear mixed model, according to our statistical analysis plan.||.02|-.01|<.05
71091192|NCT03114150|141688891|SUPERIORITY||Mean Difference (Net)|0.0|||<|0.05|TWO_SIDED|95.0|-0.03|0.02|||Mixed Models Analysis|Kenward-Roger adjustments for degrees of freedom||We tested the prediction that functional connectivity strength would increase more so for the moderate-to-vigorous training group compared to the light intensity training group. This prediction was tested with a linear mixed model, according to our statistical analysis plan.|Parameter is the interaction term for the interaction of group and session.|.02|-.03|<.05
71091193|NCT03114150|141688892|SUPERIORITY||Mean Difference (Final Values)|1.42|||<|0.05|TWO_SIDED|95.0|0.27|2.59|||Mixed Models Analysis|Residualized change model, as reported in our protocol paper.||We tested the prediction that cardiorespiratory fitness would increase more so for the moderate-to-vigorous training group compared to the light intensity training group. This prediction was tested with a linear mixed model, as reported in our protocol paper.||2.59|.27|<.05
71091194|NCT02100631|141688898|NON_INFERIORITY|The lower limit of the two sided 95% Wald CI on the difference in seroconversion rate was estimated by inverting a Z test with pooled variance. The lower limit of the CI had be greater than -10 percentage points to prove non-inferiority. The lower bound of the CI on the older adults serconversion rate was required to exceed 70%.|Risk Difference (RD)|-3.1|||||TWO_SIDED|95.0|-6.7|0.4||||||||0.4|-6.7|
71091195|NCT02100631|141688899|OTHER||Geometric Mean Ratio (GMR)|0.44|||||TWO_SIDED|95.0|0.34|0.57||||||||0.57|0.34|
71091196|NCT02100631|141688900|NON_INFERIORITY|Analysis for information only. No non-inferiority margin specified.|Risk Difference (RD)|0.6|||||TWO_SIDED|95.0|-2.2|3.5||||||||3.5|-2.2|
71091197|NCT02100631|141688901|NON_INFERIORITY|Analysis for information only. No non-inferiority margin specified.||||||0.0062|||||||t-test, 2 sided|||||||0.0062
71091198|NCT00300053|141688904|SUPERIORITY|||||||0.02|||||||ANCOVA|||Frequency of angina episodes per week 6 months after treatment.||||0.020
71091199|NCT00300053|141688904|SUPERIORITY|||||||0.035|||||||ANCOVA|||Frequency of angina episodes per week 12 months after treatment.||||0.035
71091200|NCT00300053|141688904|SUPERIORITY|||||||0.167|||||||ANCOVA|||Frequency of angina episodes per week 6 months after treatment.||||0.167
71091201|NCT00300053|141688904|SUPERIORITY|||||||0.181|||||||ANCOVA|||Frequency of angina episodes per week 12 months after treatment.||||0.181
71091202|NCT00300053|141688905|SUPERIORITY|||||||0.014|||||||ANCOVA|||Change from baseline to 6 months||||0.014
71091203|NCT00300053|141688905|SUPERIORITY|||||||0.017|||||||ANCOVA|||Change from baseline to 12 months||||0.017
71091204|NCT00300053|141688905|SUPERIORITY|||||||0.097|||||||ANCOVA|||Change from baseline to 6 months||||0.097
71091205|NCT00300053|141688905|SUPERIORITY|||||||0.134|||||||ANCOVA|||Change from baseline to 12 months||||0.134
71091206|NCT02631057|141688910|SUPERIORITY_OR_OTHER||Mean|-2.484|STANDARD_ERROR_OF_MEAN|0.629|<|0.001|TWO_SIDED|95.0|-3.717|-1.251|||Abadie-Imbens|LoS Average Treatment Effect on the Treated (ATET) \[Dabigatran group\], dispersion analysed with Abadie-Imbens's standard error.|The ATET of LoS from oral anticoagulant initiation to hospital discharge was calculated as \[Dabigatran - Warfarin\] in the matched cohort of matching ratio 1:3.|||-1.251|-3.717|<0.001
71091207|NCT00204737|141688991|OTHER|||||||0.06|||||||Fisher Exact|||comparison at 2 Weeks||||0.06
71091208|NCT00204737|141688991|OTHER|||||||0.18|||||||Fisher Exact|||Comparison at 6 Weeks||||0.18
71091209|NCT00204737|141688991|OTHER|||||||0.5|||||||Fisher Exact|||Comparison at 12 weeks||||0.5
71091210|NCT04383132|141689003|OTHER|||||||0.388||||||Independent t-test was used to compare mean CIT between two groups. The statistical significance level was accepted as p\<0.05|t-test, 2 sided|||In sample size calculation, CIT and SD were used. It was found that 326 patients (163 per group) were required to detect a 60-second difference in CIT (SD 192 secs), with 80% power and two-sided alpha 0.05. The frequency of the auxiliary maneuvers was calculated that 324 patients were required for a 20% reduction in the auxiliary maneuvers. In case of becoming lost to follow up and withdrawal, the number of patients was expanded by 5%, and a total of 346 patients, were included in the study.||||0.388
71091211|NCT04383132|141689004|OTHER|||||||0.069||||||For the comparison of ancillary maneuvers Pearson chi-square test, Fisher's exact test, and Fisher-Freeman-Halton exact test were used.|Chi-squared|||||||0.069
71091212|NCT04383132|141689005|OTHER|||||||0.487||||||Independent t-test was used to compare mean CIL between two groups.|t-test, 2 sided|||||||0.487
71091213|NCT04383132|141689006|OTHER|||||||0.822|||||||Chi-squared|||||||0.822
71091214|NCT04383132|141689007|OTHER|||||||0.016|||||||Chi-squared|||||||0.016
71091215|NCT04383132|141689008|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
71091216|NCT04383132|141689009|OTHER|||||||0.184|||||||Fisher Exact|||||||0.184
71091217|NCT02054156|141689031|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.0043|TWO_SIDED|95.0|0.37|0.83|||Cox Proportional Hazards Model||The estimate is adjusted for age strata (\>=6 months - 3 years, \>3 - 6 years, \>6 - 12 years, and \>12 - 18 years).|||0.83|0.37|0.0043
71091218|NCT02054156|141689032|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9915|TWO_SIDED|95.0|0.64|1.55|||Cox Proportional Hazards Model||The estimate is adjusted for age strata (\>=6 months - 3 years, \>3 - 6 years, \>6 - 12 years, and \>12 - 18 years).|||1.55|0.64|0.9915
71091219|NCT02054156|141689033|SUPERIORITY||Difference in % of Participants with SAE|-2.5||||0.7531|TWO_SIDED|95.0|-13.7|8.7|||Fisher Exact||95% confidence interval calculated using the Newcombe-Wilson method without continuity correction.|||8.7|-13.7|0.7531
71091220|NCT02054156|141689033|SUPERIORITY||Difference in % of Participants with AE|4.4||||0.3593|TWO_SIDED|95.0|-3.5|12.6|||Fisher Exact||95% confidence interval calculated using the Newcombe-Wilson.|||12.6|-3.5|0.3593
71091221|NCT02054156|141689034|SUPERIORITY||Rate Ratio|0.86||||0.0004|TWO_SIDED|95.0|0.8|0.94|||Poisson Regression|||Rate Ratio for Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in months. The total number of follow-up months of all participants (not per participant) in the trial was as follows: in the Azithromycin group was 1267.73 and in the Placebo group was 1193.72.||0.94|0.80|0.0004
71091222|NCT02054156|141689034|SUPERIORITY||Rate Ratio|1.25||||0.2098|TWO_SIDED|95.0|0.88|1.78|||Poisson Regression|||Rate Ratio for Serious Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in months. The total number of follow-up months of all participants (not per participant) in the trial was as follows: in the Azithromycin group was 1267.73 and in the Placebo group was 1193.72.||1.78|0.88|0.2098
71091223|NCT00297167|141689045|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-25.52|||<|0.001|TWO_SIDED|95.0|-31.73|-19.32|||ANOVA|||P-Value was calculated using analysis of variance (ANOVA) model which included main effects for treatment and sequence and participant nested in sequence as a random effect.||-19.32|-31.73|<0.001
71091224|NCT00297167|141689046|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.5|||<|0.001|TWO_SIDED|95.0|-26.85|-16.14|||ANOVA|||P-Value was calculated using analysis of variance (ANOVA)model which included main effects for treatment and sequence and participant nested in sequence as a random effect.||-16.14|-26.85|<0.001
71091225|NCT02701634|141689061|SUPERIORITY|||||||0.99||||||P-value was calculated using the stratified Cochran-Mantel-Haenszel Chi-square test.|Chi-squared|||||||0.99
71091226|NCT02701634|141689066|SUPERIORITY|||||||0.67|||||||Log Rank|||||||0.67
71091227|NCT02701634|141689067|SUPERIORITY|||||||0.33||||||P-value was calculated using the two sample proportion t-test.|t-test, 2 sided|||||||0.33
71091228|NCT02701634|141689068|SUPERIORITY|||||||0.49||||||P-value was calculated using the two sample proportion t-test.|t-test, 2 sided|||||||0.49
71091229|NCT02701634|141689069|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.8|TWO_SIDED|95.0|0.55|2.18||P-value was calculated using the log-rank test and stratified for disease severity and usage of calcineurin inhibitor or mycophenolate mofetil (MMF).|Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for disease severity and usage of calcineurin inhibitor or MMF|||2.18|0.55|0.800
71091230|NCT01129128|141689122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-173.0||||0.87|TWO_SIDED|95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of TNF alpha levels to account for skewed distribution of values||comparison of peak level of TNF alpha after controlling for baseline level. Based on data from 20 participants in a group, there was a power of 0.9 to detect a difference of 1000 pg/ml with a standard deviation of 700 pg/ml||||0.87
71091231|NCT01129128|141689122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|705.0||||0.82||95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of TNF alpha levels to account for skewed distribution of values||comparison of peak level of TNF alpha after controlling for baseline level. Based on data from 20 participants in a group, there was a power of .9 to detect a difference of 1000 pg/ml with a standard deviation of 700 pg/ml||||0.82
71091232|NCT01129128|141689123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15793.0||||0.82||95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of IL-6 levels to account for skewed distribution of values||||||0.82
71091233|NCT01129128|141689123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23472.0||||0.68||95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of IL-6 levels to account for skewed distribution of values||||||0.68
71008431|NCT02364999|141524736|EQUIVALENCE|Calculated based on 2-sided Miettinen and Nurminen method without strata for risk ratio for confirmed response. US equivalence margins (90% CI in 0.73 to 1.37).|Risk Ratio (RR)|1.0146|||||TWO_SIDED|90.0|0.8856|1.1625|||||PF-06439535 vs Bevacizumab-EU|||1.1625|0.8856|
71091234|NCT01129128|141689124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.0||||0.9||95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of Interferon gamma levels to account for skewed distribution of values||||||0.90
71091235|NCT01129128|141689124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.0||||0.76||95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of Interferon gamma levels to account for skewed distribution of values||||||0.76
71091236|NCT01129128|141689125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.98||95.0|||||Regression, Linear|controlled for baseline levels||||||0.98
71091237|NCT01129128|141689125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|39.0||||0.34||95.0|||||Regression, Linear|controlled for baseline levels||||||0.34
71091238|NCT04497883|141689127|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|% Ratio of Geometric least square means|110.41|||||TWO_SIDED|90.0|91.7|132.94|||ANOVA|||The comparison analysis was planned between Cohort A: Maribavir 400 mg and Cohort B: Maribavir 400 mg group participants only.||132.94|91.70|
71091239|NCT04497883|141689128|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|% Ratio of Geometric least square means|122.49|||||TWO_SIDED|90.0|96.83|154.95|||ANOVA|||The comparison analysis was planned between Cohort A: Maribavir 400 mg and Cohort B: Maribavir 400 mg group participants only.||154.95|96.83|
71091240|NCT04497883|141689129|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|% Ratio of Geometric least square means|125.08|||||TWO_SIDED|90.0|97.99|159.64|||ANOVA|||The comparison analysis was planned between Cohort A: Maribavir 400 mg and Cohort B: Maribavir 400 mg group participants only.||159.64|97.99|
71091241|NCT03609177|141689134|SUPERIORITY||Risk Difference (RD)|6.8|||<|0.05|TWO_SIDED|95.0|2.8|10.8|||binomial regression with identity link|||||10.8|2.8|<0.05
71091242|NCT03609177|141689135|SUPERIORITY||Risk Difference (RD)|-0.1|||<|0.05|TWO_SIDED|95.0|-0.7|0.6|||binomial regression with identity link|||||0.6|-0.7|<0.05
71091243|NCT03609177|141689136|SUPERIORITY||Risk Difference (RD)|0.7|||<|0.05|TWO_SIDED|95.0|-0.5|1.9|||binomial regression with identity link|||||1.90|-0.5|<0.05
71091244|NCT03609177|141689137|SUPERIORITY||Risk Difference (RD)|0.3|||<|0.05|TWO_SIDED|95.0|-0.4|1.0|||binomial regression with identity link|||||1.0|-0.4|<0.05
71008432|NCT02364999|141524736|EQUIVALENCE|Calculated based on 2-sided Miettinen and Nurminen method without strata for risk ratio for confirmed response. Japan equivalence margins (95% CI in 0.729 to 1.371).|Risk Ratio (RR)|1.0146|||||TWO_SIDED|95.0|0.8628|1.1933|||||PF-06439535 vs Bevacizumab-EU|||1.1933|0.8628|
71091245|NCT05722015|141689141|NON_INFERIORITY|Non-inferiority margin is 0.8.|Geometric Mean Ratio (GMR)|1.14|||<|1e-05|TWO_SIDED|96.0|1.06|1.22|||Welch's t test|One-sided p-value was calculated using the Welch's t test.|GMR was calculated as the ratio of geometric mean (GM) of Cycle 1 AUC0-6 weeks in Arm 1 to that of Arm 2. The associated 96% confidence interval (CI) were calculated using Welch's t test.|||1.22|1.06|<0.00001
71091246|NCT05722015|141689142|NON_INFERIORITY|Non-inferiority margin is 0.8.|GMR|1.67|||<|1e-05|TWO_SIDED|94.0|1.52|1.84|||Welch's t test|One sided p-value was calculated using Welch's t test.|GMR was calculated as the ratio of GM of Cycle 3 Ctrough in Arm 1 to that of Arm 2. The associated 94% CI were calculated using Welch's t test.|||1.84|1.52|<0.00001
71091247|NCT04058717|141689157|OTHER||H-statistic|10.23||||0.017|TWO_SIDED||||||Kruskal-Wallis|||||||0.017
71091248|NCT04058717|141689158|OTHER||H-statistic|7.57||||0.056|TWO_SIDED||||||Kruskal-Wallis|||||||0.056
71091249|NCT04058717|141689159|OTHER||H-statistic|1.26||||0.74|TWO_SIDED||||||Kruskal-Wallis|||||||0.74
71091250|NCT04058717|141689160|OTHER||Slope|4.13||||0.248|TWO_SIDED||||||Kruskal-Wallis|||||||0.248
71091251|NCT04058717|141689161|OTHER||H-statistic|9.33||||0.025|TWO_SIDED||||||Kruskal-Wallis|||||||0.025
71091252|NCT04058717|141689162|OTHER|||||||0.289|||||||Fisher Exact|||||||0.289
71091253|NCT03479905|141689178|SUPERIORITY|||||||0.0004|||||||Kruskal-Wallis|||||||0.0004
71091254|NCT00720759|141689179|SUPERIORITY_OR_OTHER||Slope|0.83|STANDARD_ERROR_OF_MEAN|8.54|<|0.05|TWO_SIDED|95.0|||||Regression, Linear|||A general linear model was employed. The independent variables were baseline WMFT score, treatment (condensed vs distributed), treatment (d-cycloserine vs placebo), and treatment interaction effect. The dependent measure was WMFT score at 3 months post treatment.||||<0.05
71091255|NCT02598661|141689191|SUPERIORITY||Percentage Difference|24.8|||<|0.001|TWO_SIDED|95.0|9.9|36.89||The p-value was calculated based on Cochran-Mantel-Haenszel (CMH) controlling for prior RBC transfusion burden (≤6 versus\[vs.\]\>6 units RBC) \& international prognostic scoring system (IPSS) risk group (low vs. intermediate-1) applied to randomization.|Cochran-Mantel-Haenszel||The 95% CI was calculated based on the Wilson Score method.|||36.89|9.90|<0.001
71091256|NCT02598661|141689193|SUPERIORITY||Percentage Difference|24.6|||<|0.001|TWO_SIDED|95.0|12.64|34.18||The p-value was calculated based on CMH controlling for prior RBC transfusion burden (≤6 vs. \>6 units RBC) and IPSS risk group (low vs. intermediate-1) applied to randomization.|Cochran-Mantel-Haenszel||The 95% CI was calculated based on the Wilson Score method.|||34.18|12.64|<0.001
71091257|NCT02598661|141689196|SUPERIORITY||Hazard Ratio (HR)|0.25|||<|0.001|TWO_SIDED|95.0|0.105|0.586||The p-value (2-sided) was calculated using the stratified log-rank test for superiority of imetelstat sodium versus placebo in hazard ratio.|Log Rank||Hazard ratio and 95% CI were calculated using the Cox proportional hazard model, stratified by prior RBC transfusion burden (≤ 6 vs. \> 6 units RBC) and IPSS risk group (low vs. intermediate-1), with treatment as the only covariate.|||0.586|0.105|<0.001
71091258|NCT02598661|141689197|SUPERIORITY||Percentage Difference|11.9||||0.112|TWO_SIDED|95.0|-4.1|27.56||The p-value was calculated based on CMH controlling for prior RBC transfusion burden (≤ 6 vs. \> 6 units RBC) and IPSS risk group (low vs. intermediate-1) applied to randomization.|Cochran-Mantel-Haenszel||95% CI was calculated based on the Wilson Score Method.|||27.56|-4.10|0.112
71091259|NCT02598661|141689200|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.949|TWO_SIDED|95.0|0.526|1.823||P value (two-sided) for superiority of imetelstat sodium versus placebo in hazard ratio was calculated using stratified log-rank test.|Log Rank||Hazard ratio and 95% CI were calculated from the Cox proportional hazard model, stratified by prior RBC transfusion burden (≤6 vs. \>6 units RBC) and IPSS risk group (low vs. intermediate-1), with treatment as the only covariate.|||1.823|0.526|0.949
71091260|NCT03074500|141689222|SUPERIORITY|||||||0.643|||||||Kruskal-Wallis|||Comparison of baseline values||||0.643
71091261|NCT03074500|141689222|SUPERIORITY|||||||0.018|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.018
71030624|NCT01029353|141569490|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|0.78|1.34|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis. Estimate based on model fit using only data from study survivors.||1.34|0.78|
71091262|NCT03074500|141689222|SUPERIORITY|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||Comparison of 4 week After Treatment Values||||0.027
71091263|NCT03074500|141689222|SUPERIORITY|||||||0.677||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of baseline values||||0.677
71091264|NCT03074500|141689222|SUPERIORITY|||||||0.677||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of baseline values||||0.677
71091265|NCT03074500|141689222|SUPERIORITY|||||||0.326||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of baseline values||||0.326
71091266|NCT03074500|141689222|SUPERIORITY|||||||0.019||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.019
71091267|NCT03074500|141689222|SUPERIORITY|||||||0.014||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.014
71091268|NCT03074500|141689222|SUPERIORITY|||||||0.427||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.427
71091269|NCT03074500|141689222|SUPERIORITY|||||||0.023||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.023
71091270|NCT03074500|141689222|SUPERIORITY|||||||0.021||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.021
71091271|NCT03074500|141689222|SUPERIORITY|||||||0.545||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Value||||0.545
71091272|NCT03074500|141689222|SUPERIORITY|||||||0.004|||||||Friedman's two-way analysis of variance|||||||0.004
71091273|NCT03074500|141689222|SUPERIORITY|||||||0.67|||||||Friedman's two-way analysis of variance|||||||0.670
71091274|NCT03074500|141689222|SUPERIORITY|||||||0.192|||||||Friedman's two-way analysis of variance|||||||0.192
71091275|NCT03074500|141689223|SUPERIORITY|||||||0.633|||||||Kruskal-Wallis|||Comparison of Before Treatment Values||||0.633
71091276|NCT03074500|141689223|SUPERIORITY|||||||0.282|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.282
71091277|NCT03074500|141689223|SUPERIORITY|||||||0.015|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values||||0.015
71091278|NCT03074500|141689223|SUPERIORITY|||||||0.677||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Before Treatment Values||||0.677
71091279|NCT03074500|141689223|SUPERIORITY|||||||0.344||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Before Treatment Values||||0.344
71091280|NCT03074500|141689223|SUPERIORITY|||||||0.596||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Before Treatment Values||||0.596
71091281|NCT03074500|141689223|SUPERIORITY|||||||0.161||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.161
71091282|NCT03074500|141689223|SUPERIORITY|||||||0.257||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.257
71091283|NCT03074500|141689223|SUPERIORITY|||||||0.449||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.449
71091284|NCT03074500|141689223|SUPERIORITY|||||||0.013||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.013
71091285|NCT03074500|141689223|SUPERIORITY|||||||0.019||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.019
71091286|NCT03074500|141689223|SUPERIORITY|||||||0.325||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.325
71091287|NCT03074500|141689223|SUPERIORITY|||||||0.003|||||||Friedman's two-way analysis of variance|||||||0.003
71091288|NCT03074500|141689223|SUPERIORITY|||||||0.323|||||||Friedman's two-way analysis of variance|||||||0.323
71091289|NCT03074500|141689223|SUPERIORITY|||||||0.641|||||||Friedman's two-way analysis of variance|||||||0.641
71091290|NCT03074500|141689224|SUPERIORITY|||||||0.715|||||||Kruskal-Wallis|||Comparison of Baseline Values||||0.715
71091291|NCT03074500|141689224|SUPERIORITY|||||||0.227|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.227
71091292|NCT03074500|141689224|SUPERIORITY|||||||0.012|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values||||0.012
71091293|NCT03074500|141689224|SUPERIORITY|||||||0.907||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.907
71091294|NCT03074500|141689224|SUPERIORITY|||||||0.482||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.482
71091295|NCT03074500|141689224|SUPERIORITY|||||||0.485||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.485
71091296|NCT03074500|141689224|SUPERIORITY|||||||0.129||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.129
71091297|NCT03074500|141689224|SUPERIORITY|||||||0.12||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.12
71091298|NCT03074500|141689224|SUPERIORITY|||||||0.935||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.935
71091299|NCT03074500|141689224|SUPERIORITY|||||||0.002||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.002
71091300|NCT03074500|141689224|SUPERIORITY|||||||0.036||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.036
71091301|NCT03074500|141689224|SUPERIORITY|||||||0.056||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.056
71091302|NCT03074500|141689224|SUPERIORITY|||||||0.016|||||||Friedman's two-way analysis of variance|||||||0.016
71091303|NCT03074500|141689224|SUPERIORITY|||||||0.618|||||||Friedman's two-way analysis of variance|||||||0.618
71091304|NCT03074500|141689224|SUPERIORITY|||||||0.48|||||||Friedman's two-way analysis of variance|||||||0.48
71091305|NCT03074500|141689224|SUPERIORITY|||||||0.034|||||||Wilcoxon (Mann-Whitney)|||Comparison of immediate effect between groups||||0.034
71091306|NCT03074500|141689224|SUPERIORITY|||||||0.041|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.041
71091307|NCT03074500|141689224|SUPERIORITY|||||||1|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||1
71091308|NCT03074500|141689225|SUPERIORITY|||||||0.103|||||||Kruskal-Wallis|||Comparison of Baseline Values||||0.103
71091309|NCT03074500|141689225|SUPERIORITY|||||||0.002|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.002
71091310|NCT03074500|141689225|SUPERIORITY|||||||0.008|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values||||0.008
71091311|NCT03074500|141689225|SUPERIORITY|||||||0.76||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.76
71091312|NCT03074500|141689225|SUPERIORITY|||||||1||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||1
71091313|NCT03074500|141689225|SUPERIORITY|||||||0.056||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.056
71091314|NCT03074500|141689225|SUPERIORITY|||||||0.002||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.002
71091315|NCT03074500|141689225|SUPERIORITY|||||||0.12||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.12
71091316|NCT03074500|141689225|SUPERIORITY|||||||0.117||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.117
71091317|NCT03074500|141689225|SUPERIORITY|||||||0.006||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.006
71091318|NCT03074500|141689225|SUPERIORITY|||||||0.013||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.013
71091319|NCT03074500|141689225|SUPERIORITY|||||||0.487||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.487
71091320|NCT03074500|141689225|SUPERIORITY|||||||0.002|||||||Friedman's two-way analysis of variance|||||||0.002
71091321|NCT03074500|141689225|SUPERIORITY|||||||0.102|||||||Friedman's two-way analysis of variance|||||||0.102
71091322|NCT03074500|141689225|SUPERIORITY|||||||0.165|||||||Friedman's two-way analysis of variance|||||||0.165
71091323|NCT03074500|141689225|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||Comparison of immediate effect between groups||||0.007
71091324|NCT03074500|141689225|SUPERIORITY|||||||0.028|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.028
71091325|NCT03074500|141689225|SUPERIORITY|||||||0.83|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.83
71091326|NCT03074500|141689226|SUPERIORITY|||||||0.837|||||||Kruskal-Wallis|||Comparison of Baseline Values||||0.837
71091327|NCT03074500|141689226|SUPERIORITY|||||||0.215|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.215
71091328|NCT03074500|141689226|SUPERIORITY|||||||0.078|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values||||0.078
71091329|NCT03074500|141689226|SUPERIORITY|||||||0.699||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.699
71091330|NCT03074500|141689226|SUPERIORITY|||||||0.846||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.846
71091331|NCT03074500|141689226|SUPERIORITY|||||||0.56||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.56
71091332|NCT03074500|141689226|SUPERIORITY|||||||0.087||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.087
71091333|NCT03074500|141689226|SUPERIORITY|||||||0.183||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.183
71091334|NCT03074500|141689226|SUPERIORITY|||||||0.719||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.719
71091335|NCT03074500|141689226|SUPERIORITY|||||||0.023||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.023
71091336|NCT03074500|141689226|SUPERIORITY|||||||0.196||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.196
71091337|NCT03074500|141689226|SUPERIORITY|||||||0.318||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.318
71091338|NCT03074500|141689226|SUPERIORITY|||||||0.001|||||||Friedman's two-way analysis of variance|||||||0.001
71091339|NCT03074500|141689226|SUPERIORITY|||||||0.483|||||||Friedman's two-way analysis of variance|||||||0.483
71091340|NCT03074500|141689226|SUPERIORITY|||||||0.004|||||||Friedman's two-way analysis of variance|||||||0.004
71091341|NCT03074500|141689227|SUPERIORITY|||||||0.897|||||||Kruskal-Wallis|||Comparison of Baseline Values||||0.897
71091342|NCT03074500|141689227|SUPERIORITY|||||||0.325|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.325
71091343|NCT03074500|141689227|SUPERIORITY|||||||0.172|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values||||0.172
71091344|NCT03074500|141689227|SUPERIORITY|||||||0.622||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.622
71091345|NCT03074500|141689227|SUPERIORITY|||||||0.909||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.909
71091346|NCT03074500|141689227|SUPERIORITY|||||||0.79||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.79
71091347|NCT03074500|141689227|SUPERIORITY|||||||0.24||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.24
71091348|NCT03074500|141689227|SUPERIORITY|||||||0.161||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.161
71091349|NCT03074500|141689227|SUPERIORITY|||||||0.909||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.909
71091350|NCT03074500|141689227|SUPERIORITY|||||||0.255||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.255
71091351|NCT03074500|141689227|SUPERIORITY|||||||0.058||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.058
71091352|NCT03074500|141689227|SUPERIORITY|||||||0.569||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.569
71091353|NCT03074500|141689227|SUPERIORITY|||||||0.007|||||||Friedman's two-way analysis of variance|||||||0.007
71091354|NCT03074500|141689227|SUPERIORITY|||||||0.614|||||||Friedman's two-way analysis of variance|||||||0.614
71091355|NCT03074500|141689227|SUPERIORITY|||||||0.072|||||||Friedman's two-way analysis of variance|||||||0.072
71091356|NCT03074500|141689227|SUPERIORITY|||||||0.447|||||||Wilcoxon (Mann-Whitney)|||Comparison of immediate effect between groups||||0.447
71091357|NCT03074500|141689227|SUPERIORITY|||||||0.084|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.084
71091358|NCT03074500|141689227|SUPERIORITY|||||||0.235|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.235
71091359|NCT03074500|141689228|SUPERIORITY|||||||0.958|||||||Kruskal-Wallis|||Comparison of Baseline Values||||0.958
71091360|NCT03074500|141689228|SUPERIORITY|||||||0.597|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.597
71091361|NCT03074500|141689228|SUPERIORITY|||||||0.518|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values||||0.518
71091362|NCT03074500|141689228|SUPERIORITY|||||||0.88||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.88
71091363|NCT03074500|141689228|SUPERIORITY|||||||0.733||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.733
71091364|NCT03074500|141689228|SUPERIORITY|||||||1||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||1
71091365|NCT03074500|141689228|SUPERIORITY|||||||0.404||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.404
71091366|NCT03074500|141689228|SUPERIORITY|||||||0.97||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.97
71091367|NCT03074500|141689228|SUPERIORITY|||||||0.362||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.362
71091368|NCT03074500|141689228|SUPERIORITY|||||||0.271||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.271
71091369|NCT03074500|141689228|SUPERIORITY|||||||0.519||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.519
71091370|NCT03074500|141689228|SUPERIORITY|||||||0.569||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.569
71091371|NCT03074500|141689228|SUPERIORITY|||||||0.004|||||||Friedman's two-way analysis of variance|||||||0.004
71091372|NCT03074500|141689228|SUPERIORITY|||||||0.973|||||||Friedman's two-way analysis of variance|||||||0.973
71091373|NCT03074500|141689228|SUPERIORITY|||||||0.886|||||||Friedman's two-way analysis of variance|||||||0.886
71091374|NCT03074500|141689228|SUPERIORITY|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||Comparison of immediate effect between groups||||0.82
71091375|NCT03074500|141689228|SUPERIORITY|||||||0.017|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.017
71091376|NCT03074500|141689228|SUPERIORITY|||||||0.734|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.734
71091377|NCT03857256|141689232|SUPERIORITY|Mean changes from Week 0 in LDL-C were analyzed using a restricted maximum likelihood (REML)-based repeated measures approach including effects of treatment group, time (Week 6 and Week 12) and treatment group x time interaction as well as the covariates of Week 0 value of LDL-C and Week 0 value of LDL-C x time interaction. An unstructured covariance structure were used to model the within-patient errors. Contrasts under this model allowed for the three main comparisons.||||||0.0167||||||Tests involving the comparisons of each of the active groups versus placebo for the primary endpoint were conducted at the 0.0167 significance level (to account for three main comparisons).|Mixed Models Analysis|The Kenward-Roger approximation were used to estimate denominator degrees of freedom.||Tests involving the comparisons of each of the active groups versus placebo for the primary endpoint were conducted at the 0.0167 significance level (to account for three main comparisons).||||0.0167
71091378|NCT03643848|141689296|SUPERIORITY||variance components; inferring mean diff|0.068|STANDARD_DEVIATION|0.033|<|0.046|TWO_SIDED|||||a priori threshold p\<.05|Mixed Models Analysis|REML; Satterwaite method for t-tests.Participant is random effect. Addtnl fixed effects: Valence, Condition, Anxiety Severity, Gender, Age (months).||Condition (TMR, Sham) x Valence (Negative, Neutral) predicting Lure Generalization Index at 1 week. We hypothesized a significant interaction, with a reduction in negative generalization and an increase in neutral generalization in the TMR condition.||||<.046
71091379|NCT03643848|141689297|SUPERIORITY||variance components; inferring mean diff|-0.033|STANDARD_ERROR_OF_MEAN|0.064|=|0.61|TWO_SIDED|||||a priori p\<.05|Mixed Models Analysis|included additional fixed effects: Anxiety severity, gender, age (months)||Condition (TMR, Sham) x Valence (Negative, Neutral) predicting Lure Generalization Index at 12 hour test. We hypothesized a significant interaction, with a reduction in negative generalization and an increase in neutral generalization in the TMR condition.||||=.61
71091380|NCT00090103|141689308|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.8||||0.18||95.0|0.58|1.11||Log-rank test with stratification by cluster.|Log Rank|||||1.11|0.58|0.18
71091381|NCT00090103|141689308|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.34|||<|0.001||95.0|0.26|0.45||Log-rank test with stratification by cluster.|Log Rank|||||0.45|0.26|<0.001
71091382|NCT00090103|141689310|SUPERIORITY_OR_OTHER|||||||0.18||95.0||||Log rank test with stratification by cluster.|Log Rank|||||||0.18
71091383|NCT00090103|141689310|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Log rank test with stratification by cluster.|Log Rank|||||||<0.001
71091384|NCT00090103|141689312|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.65|||<|0.001||95.0|0.52|0.8|||Log Rank|Log-rank test with stratification by cluster.||||0.80|0.52|<0.001
71091385|NCT00090103|141689312|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.59|||<|0.001||95.0|0.48|0.72|||Log Rank|||||0.72|0.48|<0.001
71091386|NCT00090103|141689313|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Log Rank|Mantel-Haenszel test with stratification by cluster.||||||0.65
71091387|NCT00090103|141689313|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Log Rank|Mantel-Hanenszel test with stratification by cluster.||||||0.10
71091388|NCT00090103|141689314|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||Log Rank|Mantel-Haenszel test with stratification by cluster.||||||0.95
71091389|NCT00090103|141689314|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Log Rank|Mantel-Haenszel test with stratification by cluster.||||||0.24
71091390|NCT04476043|141689339|SUPERIORITY||Least squares mean (LSM) difference|-2.7|STANDARD_ERROR_OF_MEAN|1.23||0.0277|TWO_SIDED|95.0|-5.2|-0.3|||MMRM|||||-0.3|-5.2|0.0277
71091391|NCT04476043|141689339|SUPERIORITY||LSM difference|-4.4|STANDARD_ERROR_OF_MEAN|1.25||0.0006|TWO_SIDED|95.0|-6.8|-1.9|||MMRM|||||-1.9|-6.8|0.0006
71091392|NCT04476043|141689339|SUPERIORITY||LSM difference|-3.8|STANDARD_ERROR_OF_MEAN|1.22||0.0021|TWO_SIDED|95.0|-6.2|-1.4|||MMRM|||||-1.4|-6.2|0.0021
71091393|NCT04476043|141689340|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0445|TWO_SIDED|95.0|1.0|5.3|||Wald test||Logistic regression model with treatment group and stratification factors (disease severity and geographical region).|||5.3|1.0|0.0445
71091394|NCT04476043|141689340|SUPERIORITY||Difference in response rate|19.2|STANDARD_ERROR_OF_MEAN|9.35|||||||||||Standard error of difference between response rates was from normal approximation.|||||
71091395|NCT04476043|141689340|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0998|TWO_SIDED|95.0|0.9|4.6|||Wald test||Logistic regression model with treatment group and stratification factors (disease severity and geographical region).|||4.6|0.9|0.0998
71091396|NCT04476043|141689340|SUPERIORITY||Difference in response rate|15.4|STANDARD_ERROR_OF_MEAN|9.32|||||||||||Standard error of difference between response rates was from normal approximation.|||||
71091397|NCT04476043|141689340|SUPERIORITY||Odds Ratio (OR)|2.1||||0.0829|TWO_SIDED|95.0|0.9|4.7|||Wald test||Logistic regression model with treatment group and stratification factors (disease severity and geographical region).|||4.7|0.9|0.0829
71091398|NCT04476043|141689340|SUPERIORITY||Difference in response rate|16.4|STANDARD_ERROR_OF_MEAN|9.29|||||||||||Standard error of difference between response rates was from normal approximation.|||||
71091399|NCT00320086|141689350|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||ANOVA|||ANOVA||||<0.05
71091400|NCT03979313|141689358|SUPERIORITY||Relative Risk Reduction (RRR)|62.15||||0.0708|TWO_SIDED|95.0|-8.57|86.8|||Poisson Model||RRR of Medi8897 versus placebo; 95% CI and p-value estimated with Poisson regression with robust variance (including stratification factors \[age at randomisation\] as covariate) obtained after multiple imputation|||86.80|-8.57|0.0708
71091401|NCT03979313|141689359|SUPERIORITY||Relative Risk Reduction (RRR)|74.53|||<|0.0001|TWO_SIDED|95.0|49.63|87.12|||Poisson Model||RRR of Medi8897 versus placebo; 95% CI and p-value estimated with Poisson regression with robust variance (including stratification factors \[age at randomisation\] as covariate) obtained after multiple imputation|||87.12|49.63|<0.0001
71091402|NCT03979313|141689360|SUPERIORITY||Relative Risk Reduction (RRR)|76.36|||<|0.0001|TWO_SIDED|95.0|62.27|85.18|||Poisson Model||RRR of Medi8897 versus placebo; 95% CI and p-value estimated with Poisson regression with robust variance (including stratification factors \[age at randomisation\] as covariate) obtained after multiple imputation|||85.18|62.27|<0.0001
71091403|NCT03979313|141689361|SUPERIORITY||Relative Risk Reduction (RRR)|76.84||||0.0002|TWO_SIDED|95.0|49.36|89.41|||Poisson Model||RRR of Medi8897 versus placebo; 95% CI and p-value estimated with Poisson regression with robust variance (including stratification factors \[age at randomisation\] as covariate) obtained after multiple imputation|||89.41|49.36|0.0002
71091404|NCT00089648|141689365|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|23.0||||||95.0|13.2|35.5|||||ORR=proportion of subjects with confirmed CR or PR, relative to total number of subjects who received at least 1 dose of study medication, were refractory to bevacizumab, had a baseline disease assessment and had the correct histological cancer type.|||35.5|13.2|
71091405|NCT03183908|141689380|NON_INFERIORITY|The one-sided non-inferiority test with the alpha level set at 0.025 and non-inferiority margin of 5%, stratified by site.|Difference in proportions|-2.7|||||TWO_SIDED|95.0|-5.8|0.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|The null hypothesis is allV3 is inferior (i.e., allV3 will have higher rates of moderate/severe injection site pain) to IIV3-HD in regards to the proportion of subjects having moderate or severe injection site pain in the first week post vaccination.||0.4|-5.8|
71091406|NCT03183908|141689382|OTHER|The comparison of the number of participants with reported SAEs regardless of relationship to study product were made using 95% confidence intervals. Results were reported using exact binomial confidence intervals.|Comparison of Frequencies|2.38|||||TWO_SIDED|95.0|1.09|4.47||||||||4.47|1.09|
71091407|NCT03183908|141689382|OTHER|The comparison of the number of participants with reported SAEs regardless of relationship to study product were made using 95% confidence intervals. Results were reported using exact binomial confidence intervals.|Comparison of Frequencies|0.79|||||TWO_SIDED|95.0|0.16|2.23||||||||2.23|0.16|
71091408|NCT03183908|141689383|NON_INFERIORITY|This objective will be assessed using a one-sided noninferiority test with the alpha level set at 0.025 and noninferiority margin of 10%. The null hypothesis is the allV3 H3N2 seroconversion rate is inferior to IIV3-HD seroconversion rate.|Difference in Proportions|-0.0579||||0.1245|ONE_SIDED|97.5|-0.1291||||Cochran-Mantel-Haenszel||The directional comparison was the lower bound of the confidence interval using a 10% non-inferiority margin.||||-.1291|0.1245
71091409|NCT03183908|141689384|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|-1.9|||||TWO_SIDED|98.0|-5.0|1.0|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Redness||1.0|-5.0|
71091410|NCT03183908|141689384|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|0.5|||||TWO_SIDED|98.0|-3.1|4.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Shoulder Pain||4.3|-3.1|
71008433|NCT02364999|141524739|OTHER|Hazard ratio of PF-06439535 versus Bevacizumab-EU; a hazard ratio =1 indicated no difference in progressive disease(PD)/death between 2 reporting groups; \>1 indicated an increase in PD/death in PF-06439535; \<1 indicated an increase in PD/death in bevacizumab-EU.|Hazard Ratio (HR)|0.8||||0.1077|TWO_SIDED|95.0|0.608|1.051|||Log Rank|Stratified by smoking, sex and region.||||1.051|0.608|0.1077
71091411|NCT03183908|141689384|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|-3.7|||||TWO_SIDED|98.0|-7.5|-0.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Swelling||-0.3|-7.5|
71091412|NCT03183908|141689384|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|1.6|||||TWO_SIDED|98.0|-2.7|5.9|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Tenderness||5.9|-2.7|
71091413|NCT03183908|141689385|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-2.4|||||TWO_SIDED|95.0|-5.2|0.2|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Redness||0.2|-5.2|
71091414|NCT03183908|141689385|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|1.3|||||TWO_SIDED|95.0|-2.3|4.9|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Shoulder Pain||4.9|-2.3|
71091415|NCT03183908|141689385|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-4.5|||||TWO_SIDED|95.0|-8.1|-1.1|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Swelling||-1.1|-8.1|
71091416|NCT03183908|141689385|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|1.6|||||TWO_SIDED|95.0|-2.7|5.9|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Tenderness||5.9|-2.7|
71091417|NCT03183908|141689385|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-3.1|||||TWO_SIDED|95.0|-6.9|0.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Injection Site Pain||0.4|-6.9|
71091418|NCT03183908|141689386|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|0.1|||||TWO_SIDED|95.0|-7.3|7.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Redness||7.3|-7.3|
71091419|NCT03183908|141689386|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-2.3|||||TWO_SIDED|95.0|-9.5|5.7|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Shoulder Pain||5.7|-9.5|
71091420|NCT03183908|141689386|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-1.2|||||TWO_SIDED|95.0|-8.6|6.1|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Swelling||6.1|-8.6|
71091421|NCT03183908|141689386|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|1.4|||||TWO_SIDED|95.0|-5.7|8.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Tenderness||8.3|-5.7|
71091422|NCT03183908|141689386|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-1.2|||||TWO_SIDED|95.0|-7.9|5.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Injection Site Pain||5.4|-7.9|
71091423|NCT03183908|141689387|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|1.8|||||TWO_SIDED|98.0|-1.7|5.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Arthralgia||5.4|-1.7|
71091424|NCT03183908|141689387|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|-0.5|||||TWO_SIDED|98.0|-2.8|2.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Chills/Shivering||2.3|-2.8|
71091425|NCT03183908|141689387|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|-1.1|||||TWO_SIDED|98.0|-4.0|1.5|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Diarrhea||1.5|-4.0|
71091426|NCT03183908|141689387|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|3.2|||||TWO_SIDED|98.0|-0.8|7.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Fatigue||7.3|-0.8|
71091427|NCT03183908|141689387|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|0.5|||||TWO_SIDED|98.0|-2.5|2.0|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Fever||2.0|-2.5|
71091428|NCT03183908|141689387|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|-0.3|||||TWO_SIDED|98.0|-3.0|2.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Headache||2.4|-3.0|
71091429|NCT03183908|141689387|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|1.8|||||TWO_SIDED|98.0|-1.7|5.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Malaise||5.4|-1.7|
71091430|NCT03183908|141689387|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|0.5|||||TWO_SIDED|98.0|-3.3|4.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Myalgia||4.4|-3.3|
71091431|NCT03183908|141689387|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|-0.8|||||TWO_SIDED|98.0|-3.1|1.6|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Nausea||1.6|-3.1|
71091432|NCT03183908|141689387|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|0.0|||||TWO_SIDED|98.0|-1.8|1.8|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Vomiting||1.8|-1.8|
71152337|NCT00531661|141796805|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||exact test of binomial proportions|P-value from exact test of binomial proportions compared proportion of all implanted patients free from DSRC to OPC of 0.80.||"Analysis of DSRC was based on the following pre-specified objective performance criteria: the lower limit of the two-sided 95.2% confidence interval on the freedom from DSRC rate for all implanted patients was at least 80%. The statistical hypotheses were:~Null: (Freedom from device / system-related complications) ≤ 80%~Alternative: (Freedom from device / system-related complications) \> 80%"||||<0.0001
71091433|NCT03183908|141689388|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|2.3|||||TWO_SIDED|95.0|-1.1|5.8|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Arthralgia||5.8|-1.1|
71091434|NCT03183908|141689388|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-0.7|||||TWO_SIDED|95.0|-3.0|2.0|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Chills/Shivering||2.0|-3.0|
71091435|NCT03183908|141689388|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-0.7|||||TWO_SIDED|95.0|-3.5|1.8|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Diarrhea||1.8|-3.5|
71091436|NCT03183908|141689388|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|2.9|||||TWO_SIDED|95.0|-1.1|7.0|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Fatigue||7.0|-1.1|
71091437|NCT03183908|141689388|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-1.0|||||TWO_SIDED|95.0|-3.0|-0.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Fever||-0.4|-3.0|
71091438|NCT03183908|141689388|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-0.4|||||TWO_SIDED|95.0|-3.2|2.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Headache||2.4|-3.2|
71091439|NCT03183908|141689388|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|0.9|||||TWO_SIDED|95.0|-2.5|4.5|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Malaise||4.5|-2.5|
71091440|NCT03183908|141689388|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.1|4.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Myalgia||4.3|-3.1|
71091441|NCT03183908|141689388|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-1.0|||||TWO_SIDED|95.0|-3.3|1.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Nausea||1.3|-3.3|
71091442|NCT03183908|141689388|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.8|1.8|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Vomiting||1.8|-1.8|
71091443|NCT03183908|141689389|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|0.05|||||TWO_SIDED|95.0|-7.2|6.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Arthralgia||6.4|-7.2|
71091444|NCT03183908|141689389|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.1|-0.6|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Diarrhea||-0.6|-8.1|
71091445|NCT03183908|141689389|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|3.7|||||TWO_SIDED|95.0|-3.6|10.9|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Fatigue||10.9|-3.6|
71091446|NCT03183908|141689389|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.4|6.6|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Fever||6.6|-2.4|
71091447|NCT03183908|141689389|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|5.0|||||TWO_SIDED|95.0|2.0|12.2|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Malaise||12.2|2.0|
71091448|NCT03183908|141689389|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|0.1|||||TWO_SIDED|95.0|-7.3|7.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Myalgia||7.3|-7.3|
71091449|NCT03183908|141689390|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.5862|||||||Wilcoxon (Mann-Whitney)|||Activity Limitation Changes for Day 1 to Day 3 Group Comparisons||||0.5862
71091450|NCT03183908|141689390|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.5648|||||||Wilcoxon (Mann-Whitney)|||Daily Activities Changes for Day 1 to Day 3 Group Comparisons||||0.5648
71091451|NCT03183908|141689390|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.4196|||||||Wilcoxon (Mann-Whitney)|||Basic Mobility Changes from Day 1 to Day 3 Group Comparisons||||0.4196
71091452|NCT03183908|141689390|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.2418|||||||Wilcoxon (Mann-Whitney)|||Participation Restriction Changes from Day 1 to Day 3 Group Comparisons||||0.2418
71091453|NCT03183908|141689390|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.0746|||||||Wilcoxon (Mann-Whitney)|||Social Roles Changes for Day 1 to Day 3 Group Comparisons||||0.0746
71091454|NCT03183908|141689390|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.5497|||||||Wilcoxon (Mann-Whitney)|||Instrumental Roles Changes for Day 1 to Day 3 Group Comparisons||||0.5497
71091455|NCT03183908|141689391|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.6278|||||||Wilcoxon (Mann-Whitney)|||Activity Limitation Changes for Day 1 to Day 3 Group Comparisons||||0.6278
71091456|NCT03183908|141689391|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.5622|||||||Wilcoxon (Mann-Whitney)|||Daily Activities Changes for Day 1 to Day 3 Group Comparisons||||0.5622
71091457|NCT03183908|141689391|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.5538|||||||Wilcoxon (Mann-Whitney)|||Basic Mobility Changes for Day 1 to Day 3 Group Comparisons||||0.5538
71091458|NCT03183908|141689391|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.231|||||||Wilcoxon (Mann-Whitney)|||Participation Restriction Changes from Day 1 to Day 3 Group Comparisons||||0.2310
71091459|NCT03183908|141689391|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.0435|||||||Wilcoxon (Mann-Whitney)|||Social Roles Changes from Day 1 to Day 3 Group Comparisons||||0.0435
71091460|NCT03183908|141689391|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.6519|||||||Wilcoxon (Mann-Whitney)|||Instrumental Roles Changes from Day 1 to Day 3 Group Comparisons||||0.6519
71091461|NCT03183908|141689392|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.7483|||||||Wilcoxon (Mann-Whitney)|||Activity Limitation Changes from Day 1 to Day 3 Group Comparisons||||0.7483
71091462|NCT03183908|141689392|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.7483|||||||Wilcoxon (Mann-Whitney)|||Daily Activities Changes for Day 1 to Day 3 Group Comparisons||||0.7483
71091463|NCT03183908|141689392|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.4953|||||||Wilcoxon (Mann-Whitney)|||Basic Mobility Changes for Day 1 to Day 3 Group Comparisons||||0.4953
71091464|NCT03183908|141689392|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.8669|||||||Wilcoxon (Mann-Whitney)|||Participation Restriction Changes for Day 1 to Day 3 Group Comparisons||||0.8669
71091465|NCT03183908|141689392|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.8451|||||||Wilcoxon (Mann-Whitney)|||Social Roles Changes for Day 1 to Day 3 Group Comparisons||||0.8451
71091466|NCT03183908|141689392|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.7376|||||||Wilcoxon (Mann-Whitney)|||Instrumental Roles Changes for Day 1 to Day 3 Group Comparisons||||0.7376
71091467|NCT03183908|141689393|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.7407|||||||Wilcoxon (Mann-Whitney)|||US Index Score Changes for Day 1 to Day 3 Group Comparisons||||0.7407
71091468|NCT03183908|141689394|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.4032|||||||Wilcoxon (Mann-Whitney)|||US Index Score Changes for Day 1 to Day 3 Group Comparisons||||0.4032
71091469|NCT03183908|141689395|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.4079|||||||Wilcoxon (Mann-Whitney)|||US Index Score Changes from Day 1 to Day 3 Group Comparisons||||0.4079
71091470|NCT03183908|141689396|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.7948|||||||Wilcoxon (Mann-Whitney)|||EQ VAS Changes for Day 1 to Day 3 Group Comparisons||||0.7948
71091471|NCT03183908|141689397|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. Alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.7953|||||||Wilcoxon (Mann-Whitney)|||EQ VAS Changes from Day 1 to Day 3 Group Comparisons||||0.7953
71091472|NCT03183908|141689398|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.9329|||||||Wilcoxon (Mann-Whitney)|||EQ VAS Changes from Day 1 to Day 3 Group Comparisons||||0.9329
71091473|NCT02690727|141689447|SUPERIORITY_OR_OTHER||Ratio (%)|128.49||||0.0002|TWO_SIDED|90.0|119.13|138.59|||ANOVA|||||138.59|119.13|0.0002
71091474|NCT02690727|141689449|SUPERIORITY_OR_OTHER||Ratio (%)|139.27||||0.0278|TWO_SIDED|90.0|111.01|174.73|||ANOVA|||||174.73|111.01|0.0278
71091475|NCT02471339|141689507|SUPERIORITY|||||||0.05|||||||ANCOVA|||Analysis of covariance. Analyses for primary and secondary outcomes were two-tailed and alpha was set to 0.05. An a priori analysis suggested that, to detect a change of .68 standard deviation on the primary outcome measure between the two groups at .80 power, 41 patients per group would be needed.||||0.05
71091476|NCT02471339|141689508|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
71091477|NCT02471339|141689511|SUPERIORITY|||||||0.05|||||||t-test|||||||.05
71091478|NCT02471339|141689515|SUPERIORITY|||||||0.042|||||||ANOVA|||||||0.042
71091479|NCT00303186|141689560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75|STANDARD_DEVIATION|7.03|<|0.0001|TWO_SIDED|95.0|2.4|5.1|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||5.10|2.40|<0.0001
71091480|NCT00303186|141689560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.72|STANDARD_DEVIATION|7.47|<|0.001|TWO_SIDED|95.0|1.65|5.78|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||5.78|1.65|<0.001
71091481|NCT00303186|141689560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_DEVIATION|4.1||0.518|TWO_SIDED|95.0|-1.5|0.76|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||0.76|-1.50|0.518
71091482|NCT00303186|141689561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.72|STANDARD_DEVIATION|27.89|<|0.0001|TWO_SIDED|95.0|12.38|23.07|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||23.07|12.38|<0.0001
71091483|NCT00303186|141689561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.6|STANDARD_DEVIATION|20.36|<|0.0001|TWO_SIDED|95.0|6.99|18.21|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||18.21|6.99|<0.0001
71091484|NCT00303186|141689561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|STANDARD_DEVIATION|18.7||0.833|TWO_SIDED|95.0|-5.7|4.61|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||4.61|-5.70|0.833
71091485|NCT00303186|141689562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.72|STANDARD_DEVIATION|2.39|<|0.0001|TWO_SIDED|95.0|2.26|3.18|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||3.18|2.26|<0.0001
71091486|NCT00303186|141689562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.23|STANDARD_DEVIATION|2.36|<|0.0001|TWO_SIDED|95.0|1.59|2.87|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||2.87|1.59|<0.0001
71091487|NCT00303186|141689562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|STANDARD_DEVIATION|2.03||0.309|TWO_SIDED|95.0|-0.83|0.27|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||0.27|-0.83|0.309
71091488|NCT00303186|141689564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.66|STANDARD_DEVIATION|11.75||0.004|TWO_SIDED|95.0|1.619|8.301|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||8.301|1.619|0.004
71091489|NCT00303186|141689565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.76|STANDARD_DEVIATION|18.8||0.015|TWO_SIDED|95.0|-12.155|-1.355|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||-1.355|-12.155|0.015
71091490|NCT00303186|141689566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_DEVIATION|7.41||0.676|TWO_SIDED|95.0|-1.666|2.546|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||2.546|-1.666|0.676
71091491|NCT00303186|141689567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.486|STANDARD_DEVIATION|2.96|<|0.0001|TWO_SIDED|95.0|0.918|2.05|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||2.05|0.918|<0.0001
71091492|NCT00303186|141689567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_DEVIATION|3.64|<|0.001|TWO_SIDED|95.0|1.01|2.99|||t-test, 1 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||2.99|1.01|<0.001
71091493|NCT00303186|141689567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|STANDARD_DEVIATION|3.32||0.223|TWO_SIDED|95.0|-0.35|1.46|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||1.46|-0.35|0.223
71091494|NCT00303186|141689568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.33|STANDARD_DEVIATION|5.94|<|0.0001|TWO_SIDED|95.0|5.1|7.47|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: swollen joints and Month 12: swollen joints.||7.47|5.10|<0.0001
71091495|NCT00303186|141689568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2|STANDARD_DEVIATION|6.35|<|0.0001|TWO_SIDED|95.0|4.48|7.92|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: swollen joints and Month 60: swollen joints.||7.92|4.48|<0.0001
71091496|NCT00303186|141689568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|2.09||0.479|TWO_SIDED|95.0|-0.36|0.76|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12: swollen joints and Month 60: swollen joints.||0.76|-0.36|0.479
71091497|NCT00303186|141689568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.0|STANDARD_DEVIATION|11.16|<|0.0001|TWO_SIDED|95.0|6.86|11.13|||t-test, 1 sided|||Statistical analysis was carried out between categories, Baseline: tender joints and Month 12: tender joints.||11.13|6.86|<0.0001
71091498|NCT00303186|141689568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_DEVIATION|9.25|<|0.0001|TWO_SIDED|95.0|6.1|11.1|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: tender joints and Month 60: tender joints.||11.10|6.10|<0.0001
71091499|NCT00303186|141689568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66|STANDARD_DEVIATION|8.92||0.588|TWO_SIDED|95.0|-1.76|3.07|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12: tender joints and Month 60: tender joints.||3.07|-1.76|0.588
71091500|NCT00303186|141689572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|STANDARD_DEVIATION|11.29||0.33|TWO_SIDED|95.0|-1.3|3.82|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||3.82|-1.30|0.330
71091501|NCT00303186|141689572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.56|STANDARD_DEVIATION|32.28||0.449|TWO_SIDED|95.0|-33.37|16.26|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||16.26|-33.37|0.449
71091502|NCT00303186|141689572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.0|STANDARD_DEVIATION|38.17||0.165|TWO_SIDED|95.0|-37.04|7.04|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||7.04|-37.04|0.165
71091503|NCT00303186|141689573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.18|STANDARD_DEVIATION|24.48|<|0.0001|TWO_SIDED|95.0|26.44|35.91|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||35.91|26.44|<0.0001
71091504|NCT00303186|141689573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.76|STANDARD_DEVIATION|23.24|<|0.0001|TWO_SIDED|95.0|22.42|35.1|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||35.10|22.42|<0.0001
71091505|NCT00303186|141689573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05|STANDARD_DEVIATION|24.6||0.538|TWO_SIDED|95.0|-8.7|4.6|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||4.60|-8.70|0.538
71091506|NCT00303186|141689574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.83|STANDARD_DEVIATION|19.6|<|0.0001|TWO_SIDED|95.0|30.04|37.63|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||37.63|30.04|<0.0001
71091507|NCT00303186|141689574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.04|STANDARD_DEVIATION|21.17|<|0.0001|TWO_SIDED|95.0|31.96|44.12|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||44.12|31.96|<0.0001
71091508|NCT00303186|141689574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.38|STANDARD_DEVIATION|17.59||0.343|TWO_SIDED|95.0|-2.62|7.38|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||7.38|-2.62|0.343
71091509|NCT00303186|141689575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.18|STANDARD_DEVIATION|27.56|<|0.0001|TWO_SIDED|95.0|25.88|36.49|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||36.49|25.88|<0.0001
71091510|NCT00303186|141689575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.8|STANDARD_DEVIATION|25.89|<|0.0001|TWO_SIDED|95.0|21.52|36.09|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||36.09|21.52|<0.0001
71091511|NCT00303186|141689575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.33|STANDARD_DEVIATION|22.77||0.301|TWO_SIDED|95.0|-9.74|3.07|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||3.07|-9.74|0.301
71091512|NCT00303186|141689576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.21|STANDARD_DEVIATION|123.2|<|0.0001|TWO_SIDED|95.0|2.01|50.4|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Baseline and Month 12.||50.40|2.01|<0.0001
71091513|NCT00303186|141689576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.19|STANDARD_DEVIATION|18.3|<|0.0001|TWO_SIDED|95.0|7.81|18.57|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Baseline and Month 60.||18.57|7.81|<0.0001
71091514|NCT00303186|141689576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.31|STANDARD_DEVIATION|14.07||0.132|TWO_SIDED|95.0|-6.4|1.77|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Month 12 and Month 60.||1.77|-6.40|0.132
71091515|NCT00303186|141689577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.26|STANDARD_DEVIATION|150.1|<|0.0005|TWO_SIDED|95.0|-13.52|46.04|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Baseline and Month 12.||46.04|-13.52|<0.0005
71091516|NCT00303186|141689577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|52.81|STANDARD_DEVIATION|100.25|<|0.0001|TWO_SIDED|95.0|22.33|83.29|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Baseline and Month 60.||83.29|22.33|<0.0001
71091517|NCT00303186|141689577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.4|STANDARD_DEVIATION|147.25||0.034|TWO_SIDED|95.0|-10.84|77.64|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Month 12 and Month 60.||77.64|-10.84|0.034
71091518|NCT00303186|141689579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48|STANDARD_DEVIATION|0.66|<|0.0001|TWO_SIDED|95.0|0.35|0.62|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||0.62|0.35|<0.0001
71091519|NCT00303186|141689579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_DEVIATION|0.56|<|0.0001|TWO_SIDED|95.0|0.26|0.56|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||0.56|0.26|<0.0001
71091520|NCT00303186|141689579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.61||0.6|TWO_SIDED|95.0|-0.24|0.14|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||0.14|-0.24|0.600
71091521|NCT00303186|141689580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|STANDARD_DEVIATION|0.31|<|0.0001|TWO_SIDED|95.0|0.18|0.3|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||0.30|0.18|<0.0001
71091522|NCT00303186|141689580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_DEVIATION|0.34|<|0.0001|TWO_SIDED|95.0|-0.31|-0.12|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||-0.12|-0.31|<0.0001
71091523|NCT00303186|141689580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.27||0.789|TWO_SIDED|95.0|-0.08|0.06|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||0.06|-0.08|0.789
71091524|NCT00303186|141689581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.4|STANDARD_DEVIATION|25.0|<|0.0001|TWO_SIDED|95.0|14.59|24.22|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||24.22|14.59|<0.0001
71091525|NCT00303186|141689581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.68|STANDARD_DEVIATION|22.08||0.0001|TWO_SIDED|95.0|-18.77|-6.59|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||-6.59|-18.77|0.0001
71091526|NCT00303186|141689581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.85|STANDARD_DEVIATION|22.22||0.115|TWO_SIDED|95.0|-1.21|10.92|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||10.92|-1.21|0.115
71091527|NCT00303186|141689582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.41|STANDARD_DEVIATION|10.1|<|0.0001|TWO_SIDED|95.0|-10.34|-4.47|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: physical component score and Month 12: physical component score.||-4.47|-10.34|<0.0001
71091528|NCT00303186|141689582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.94|STANDARD_DEVIATION|9.13|<|0.0001|TWO_SIDED|95.0|-8.56|-3.32|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: physical component score and Month 60: physical component score.||-3.32|-8.56|<0.0001
71091529|NCT00303186|141689582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25|STANDARD_DEVIATION|8.83||0.308|TWO_SIDED|95.0|-1.19|3.68|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12: physical component score and Month 60: physical component score.||3.68|-1.19|0.308
71091530|NCT00303186|141689582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_DEVIATION|8.51||0.589|TWO_SIDED|95.0|-3.14|1.8|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: mental component score and Month 12: mental component score.||1.80|-3.14|0.589
71091531|NCT00303186|141689582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.59|STANDARD_DEVIATION|12.29||0.003|TWO_SIDED|95.0|-9.12|-2.06|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: mental component score and Month 60: mental component score.||-2.06|-9.12|0.003
71091532|NCT00303186|141689582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7|STANDARD_DEVIATION|12.8||0.002|TWO_SIDED|95.0|-9.23|-2.18|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12: mental component score and Month 60: mental component score.||-2.18|-9.23|0.002
71091533|NCT00267670|141689584|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|1.0||0.46|||||||ANOVA|||Sample size estimates were based on 30% reduction in ALT in the treatment group \& 15% reduction in the placebo group. With a sample size of 30 planned (20 treatment:10 placebo), the study was designed to have a power of 90% to detect a difference in means of 1.25 standard deviations (ES=1.25), \& a power of 80% to detect a difference in means of 1.1 standard deviations (ES=1.1), based on calculations using power index, z-table, \& accounting for unequal sample size: n1 = 20, n2 = 10, a = 0.05.||||0.46
71091534|NCT00267670|141689585|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||t-test, 2 sided|||Null hypothesis was that there was no difference between mean hepatic expression of TNF-alpha receptors in patient with NASH. This was a secondary outcome and no power analysis was done.||||0.16
71091535|NCT00267670|141689586|SUPERIORITY_OR_OTHER|||||||0.94|||||||t-test, 2 sided|||||||0.94
71091536|NCT00267670|141689587|SUPERIORITY_OR_OTHER|||||||0.49|||||||t-test, 2 sided|||||||0.49
71091537|NCT01933594|141689639|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
71091538|NCT01933594|141689640|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.94
71091539|NCT01933594|141689640|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.74
71091540|NCT01933594|141689640|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.18
71091541|NCT01933594|141689640|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.16
71091542|NCT01933594|141689641|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
71091543|NCT01933594|141689642|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.9
71091544|NCT01933594|141689642|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.07
71091545|NCT01933594|141689642|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.88
71091546|NCT01933594|141689642|SUPERIORITY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.92
71091547|NCT01933594|141689643|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 6 hours post infusion||||0.44
71091548|NCT01933594|141689643|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 12 hours post infusion||||0.024
71091549|NCT01933594|141689643|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.37
71091550|NCT01933594|141689643|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 14 days post infusion||||0.79
71091551|NCT01933594|141689643|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.34
71091552|NCT01933594|141689644|SUPERIORITY|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||||||0.029
71091553|NCT01933594|141689645|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
71091554|NCT01933594|141689646|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
71091555|NCT01933594|141689648|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.19
71091556|NCT01933594|141689648|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.63
71091557|NCT01933594|141689648|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 72 hours post infusion 2||||0.94
71091558|NCT01933594|141689648|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.66
71091559|NCT01933594|141689648|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.17
71091560|NCT01933594|141689649|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion||||0.73
71091561|NCT01933594|141689649|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 14 days post infusion||||0.9
71091562|NCT01933594|141689650|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.8
71091563|NCT01933594|141689650|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.73
71091564|NCT01933594|141689650|SUPERIORITY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 72 hours post infusion 2||||0.84
71091565|NCT01933594|141689650|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.88
71091566|NCT01933594|141689650|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.64
71091567|NCT01933594|141689658|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.34
71091568|NCT01933594|141689658|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.004
71091569|NCT01933594|141689658|SUPERIORITY|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.022
71091570|NCT01933594|141689658|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.008
71091571|NCT01933594|141689658|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 2 weeks post infusion 4||||0.55
71091572|NCT01933594|141689658|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 5 weeks post infusion 4||||0.48
71091573|NCT01933594|141689658|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.54
71091574|NCT01933594|141689658|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 18 weeks post infusion 4||||0.47
71091575|NCT01933594|141689660|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion||||0.95
71091576|NCT01933594|141689660|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.07
71091577|NCT01933594|141689660|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.26
71091578|NCT01933594|141689661|SUPERIORITY|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion||||0.89
71091579|NCT01933594|141689661|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.14
71091580|NCT01933594|141689661|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.74
71091581|NCT01933594|141689662|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion||||0.71
71091582|NCT01933594|141689662|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.79
71091583|NCT01933594|141689662|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.38
71091584|NCT01933594|141689663|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion||||1
71091585|NCT01933594|141689663|SUPERIORITY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.92
71091586|NCT01933594|141689663|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.66
71091587|NCT01933594|141689664|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||1
71091588|NCT01933594|141689664|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.9
71091589|NCT01933594|141689664|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.47
71091590|NCT01933594|141689665|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.63
71091591|NCT01933594|141689665|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||hange from baseline to 24 hours post infusion 4||||0.51
71091592|NCT01933594|141689665|SUPERIORITY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.028
71091593|NCT01933594|141689666|SUPERIORITY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.62
71091594|NCT01933594|141689666|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.15
71091595|NCT01933594|141689666|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.69
71091596|NCT01933594|141689667|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.28
71091597|NCT01933594|141689667|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.15
71091598|NCT01933594|141689667|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.81
71091599|NCT01933594|141689668|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion||||0.13
71091600|NCT01933594|141689668|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.22
71091601|NCT01933594|141689668|SUPERIORITY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.031
71091602|NCT01933594|141689669|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion||||0.13
71091603|NCT01933594|141689669|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.39
71091604|NCT01933594|141689669|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.12
71091605|NCT01933594|141689670|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.7
71091606|NCT01933594|141689670|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.51
71091607|NCT01933594|141689670|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.94
71091608|NCT01933594|141689671|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.78
71091609|NCT01933594|141689671|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.41
71091610|NCT01933594|141689671|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.94
71091611|NCT01933594|141689672|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||Change in pNFKB+% on CD4||||0.69
71091612|NCT01933594|141689672|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Change in pS175% on CD4||||0.27
71091613|NCT01933594|141689673|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Change in pNFKB+% on CD8||||0.81
71091614|NCT01933594|141689673|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Change in pS175% on CD8||||0.81
71091615|NCT01933594|141689674|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.37
71091616|NCT01933594|141689674|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.1
71091617|NCT01933594|141689674|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 72 hours post infusion 2||||0.28
71091618|NCT01933594|141689674|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.16
71091619|NCT01933594|141689674|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.12
71091620|NCT01933594|141689675|SUPERIORITY|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.027
71091621|NCT01933594|141689675|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.004
71008434|NCT02364999|141524740|OTHER|Hazard ratio of PF-06439535 versus Bevacizumab-EU; a hazard ratio =1 indicated no difference in progressive disease(PD)/death between 2 reporting groups; \>1 indicated an increase in PD/death in PF-06439535; \<1 indicated an increase in PD/death in bevacizumab-EU.|Hazard Ratio (HR)|0.931||||0.4492||95.0|0.777|1.116|||Log Rank|Stratified by smoking, sex and region.||||1.116|0.777|0.4492
71091622|NCT01933594|141689675|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 72 hours post infusion 2||||0.1
71091623|NCT01933594|141689675|SUPERIORITY|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.022
71091624|NCT01933594|141689675|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.17
71091625|NCT00315445|141689676|SUPERIORITY_OR_OTHER|||||||0.035||||||P values are from a repeated measures model|Mixed Models Analysis|||A repeated measures analysis was performed to assess the effects due to treatment, center, and treatment by center interaction. Observations within each subject were assumed to follow a first-order autoregressive model. Missing values were extrapolated by the last observation carried forward (LOCF). Covariates were gender, age, race, weight, baseline pain, and previous opioid use which were incorporated into the model when P \< 0.10, using a backward elimination procedure.||||0.0350
71091626|NCT00315445|141689676|SUPERIORITY_OR_OTHER|||||||0.0624||||||Repeated measures analysis to assess the effects due to treatment, center, and treatment by center. Missing values = last observation carried forward (LOCF). Covariates: gender, age, race, weight, baseline pain, and previous opioid use.|Mixed Models Analysis|||||||0.0624
71091627|NCT00315445|141689677|SUPERIORITY_OR_OTHER||Day 84 Mean|46.4|||||TWO_SIDED|90.0|40.2|48.7|||Day 84 Mean|||||48.7|40.2|
71091628|NCT00315445|141689677|SUPERIORITY_OR_OTHER||Day 84 Mean|44.5|||||TWO_SIDED|90.0|43.3|52.4|||Day 84 Mean|||||52.4|43.3|
71091629|NCT00315445|141689677|SUPERIORITY_OR_OTHER||Day 84 Mean|46.5|||||TWO_SIDED|90.0|41.7|50.2|||Day 84 Mean|||||50.2|41.7|
71091630|NCT00315445|141689678|SUPERIORITY_OR_OTHER||Day 84 Mean|18.9|||||TWO_SIDED|90.0|5.2|26.2|||Day 84 Mean|||||26.2|5.2|
71091631|NCT00315445|141689678|SUPERIORITY_OR_OTHER||Day 84 Mean|24.4|||||TWO_SIDED|90.0|10.7|32.0|||Day 84 Mean|||||32.0|10.7|
71091632|NCT00315445|141689678|SUPERIORITY_OR_OTHER||Day 84 Mean|33.9|||||TWO_SIDED|90.0|16.0|35.2|||Day 84 Mean|||||35.2|16.0|
71091633|NCT00315445|141689679|SUPERIORITY_OR_OTHER|||||||0.0452||||||Multiple linear regression|Mixed Models Analysis|||A repeated measures analysis was performed to assess the effects due to treatment, center, and treatment by center interaction. Observations within each subject were assumed to follow a first-order autoregressive model. Missing values were extrapolated by the last observation carried forward (LOCF). Covariates were gender, age, race, weight, baseline pain, and previous opioid use which were incorporated into the model when P \< 0.10, using a backward elimination procedure.||||0.0452
71091634|NCT00315445|141689679|SUPERIORITY_OR_OTHER|||||||0.0962|||||||Mixed Models Analysis|||||||0.0962
71091635|NCT00315445|141689680|SUPERIORITY_OR_OTHER||Day 84 Mean|35.3|||||TWO_SIDED|90.0|24.3|35.6|||Day 84 Mean|||||35.6|24.3|
71091636|NCT00315445|141689680|SUPERIORITY_OR_OTHER||Day 84 Mean|39.0|||||TWO_SIDED|90.0|29.0|40.3|||Day 84 Mean|||||40.3|29.0|
71091637|NCT00315445|141689680|SUPERIORITY_OR_OTHER||Day 84 Mean|41.9|||||TWO_SIDED|90.0|32.1|42.5|||Day 84 Mean|||||42.5|32.1|
71091638|NCT00315445|141689681|SUPERIORITY_OR_OTHER||Day 84 Mean|52.4||||||90.0|50.3|56.6|||Day 84 Mean|||||56.6|50.3|
71091639|NCT00315445|141689681|SUPERIORITY_OR_OTHER||Day 84 Mean|52.5|||||TWO_SIDED|90.0|51.8|58.3|||Day 84 Mean|||||58.3|51.8|
71091640|NCT00315445|141689681|SUPERIORITY_OR_OTHER||Day 84 Mean|57.7|||||TWO_SIDED|90.0|52.3|58.6|||Day 84 Mean|||||58.6|52.3|
71091641|NCT00315445|141689684|SUPERIORITY_OR_OTHER||Day 84 Mean|55.3|||||TWO_SIDED|90.0|49.8|67.9|||Day 84 Mean|||||67.9|49.8|
71091642|NCT00315445|141689684|SUPERIORITY_OR_OTHER||Day 84 Mean|56.3|||||TWO_SIDED|90.0|45.9|65.3|||Day 84 Mean|||||65.3|45.9|
71091643|NCT00315445|141689684|SUPERIORITY_OR_OTHER||Day 84 Mean|63.0|||||TWO_SIDED|90.0|53.1|70.9|||Day 84 Mean|||||70.9|53.1|
71091644|NCT00315445|141689685|SUPERIORITY_OR_OTHER||Day 84 Mean|67.4|||||TWO_SIDED|90.0|61.3|68.6|||Day 84 Mean|||||68.6|61.3|
71091645|NCT00315445|141689685|SUPERIORITY_OR_OTHER||Day 84 Mean|68.8|||||TWO_SIDED|90.0|61.7|68.8|||Day 84 Mean|||||68.8|61.7|
71091646|NCT00315445|141689685|SUPERIORITY_OR_OTHER||Day 84 Mean|67.8|||||TWO_SIDED|90.0|62.0|68.7|||Day 84 Mean|||||68.7|62.0|
71091647|NCT00315445|141689690|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.67||||0.054|||||||Regression, Cox|For the secondary outcome measure no alpha adjustment for multiple comparison was performed.||||||0.054
71091648|NCT00315445|141689690|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51||||0.138|||||||Regression, Cox|For the secondary outcome measure no alpha adjustment for multiple comparison was performed.||||||0.138
71091649|NCT00315445|141689691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.0105|||||||Regression, Cox|For the secondary outcomes no alpha adjustment for multiple comparison was performed.||||||0.0105
71091650|NCT00315445|141689691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.04||||0.0024|||||||Regression, Cox|For the secondary outcome measure no alpha adjustment for multiple comparison was performed.||||||0.0024
71091651|NCT00315445|141689692|SUPERIORITY_OR_OTHER|||||||0.033|||||||Mixed Models Analysis|||||||.033
71091652|NCT00315445|141689692|SUPERIORITY_OR_OTHER|||||||0.043|||||||Mixed Models Analysis|||||||.043
71091653|NCT00315445|141689693|SUPERIORITY_OR_OTHER|||||||0.011|||||||Mixed Models Analysis|||||||.011
71091654|NCT00315445|141689693|SUPERIORITY_OR_OTHER|||||||0.034|||||||Mixed Models Analysis|||||||.034
71091655|NCT00315445|141689694|SUPERIORITY_OR_OTHER|||||||0.038|||||||Mixed Models Analysis|||||||.038
71091656|NCT00315445|141689694|SUPERIORITY_OR_OTHER|||||||0.63|||||||Mixed Models Analysis|||||||0.63
71091657|NCT00315445|141689695|SUPERIORITY_OR_OTHER|||||||0.064|||||||Mixed Models Analysis|||||||.064
71091658|NCT00315445|141689695|SUPERIORITY_OR_OTHER|||||||0.066|||||||Mixed Models Analysis|||||||.066
71091659|NCT00315445|141689696|SUPERIORITY_OR_OTHER|||||||0.607|||||||Mixed Models Analysis|||||||.607
71091660|NCT00315445|141689696|SUPERIORITY_OR_OTHER|||||||0.94|||||||Mixed Models Analysis|||||||.940
71091661|NCT00315445|141689697|SUPERIORITY_OR_OTHER|||||||0.702|||||||Mixed Models Analysis|||||||.702
71091662|NCT00315445|141689697|SUPERIORITY_OR_OTHER|||||||0.634|||||||Mixed Models Analysis|||||||.634
71091663|NCT01811238|141689698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69|STANDARD_DEVIATION|2.18|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|"The primary endpoint will be the actual reduction rate of pain intensity (0 -10) score at 8 weeks.~It will be analyzed by using paired t-test."||||||<0.05
71091664|NCT01811238|141689699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_DEVIATION|0.37|<|0.05|TWO_SIDED|95.0|0.0|1.12|||t-test, 2 sided|The change(difference) in EQ-5D score at Week 8 from baseline was analyzed by using paired t-test.||||1.12|0|<0.05
71091665|NCT02164916|141689723|SUPERIORITY||Hazard Ratio (HR)|0.48||||0.001|TWO_SIDED|95.0|0.31|0.75|||Log Rank|||||0.75|0.31|0.001
71091666|NCT03454555|141689753|SUPERIORITY||Mean Difference (Final Values)|-5.6||||0.31|TWO_SIDED|95.0|-16.6|5.3|||Mixed Models Analysis|||||5.3|-16.6|0.31
71091667|NCT03454555|141689754|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.963|TWO_SIDED|95.0|-10.3|10.7|||Mixed Models Analysis|||||10.7|-10.3|0.963
71091668|NCT03454555|141689755|SUPERIORITY||Mean Difference (Final Values)|-6.2||||0.253|TWO_SIDED|95.0|-16.8|4.4|||Mixed Models Analysis|||||4.4|-16.8|0.253
71091669|NCT03454555|141689756|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.9|TWO_SIDED|95.0|-10.1|11.5|||Mixed Models Analysis|||||11.5|-10.1|0.90
71091670|NCT03454555|141689757|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.65|TWO_SIDED|95.0|-13.7|8.6|||Mixed Models Analysis|||||8.6|-13.7|0.65
71091671|NCT03454555|141689758|SUPERIORITY||Mean Difference (Final Values)|9.4||||0.102|TWO_SIDED|95.0|-1.9|20.8|||Mixed Models Analysis|||||20.8|-1.9|0.102
71091672|NCT03454555|141689759|SUPERIORITY||Odds Ratio (OR)|0.93||||0.83|TWO_SIDED|95.0|0.5|1.75|||Mixed Models Analysis|Used a logistic mixed model for repeated measures||||1.75|0.50|0.83
71091673|NCT03454555|141689760|SUPERIORITY||Odds Ratio (OR)|0.79||||0.47|TWO_SIDED|95.0|0.42|1.5|||Mixed Models Analysis|Used a logistic mixed model for repeated measures||||1.50|0.42|0.47
71152338|NCT00531661|141796806|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||exact test of binomial proportions|P-value from exact test of binomial proportions compared proportion of all implanted patients free from pressure sensor failure to OPC of 0.90.||"Analysis of sensor failures was based on the following pre-specified objective performance criteria: the lower limit of the two-sided 95.2% confidence interval on the freedom from pressure sensor failure rate for all implanted patients was at least 90%. The statistical hypotheses were:~Null: (Freedom from device / system-related complications) ≤ 90%~Alternative: (Freedom from device / system-related complications) \> 90%"||||<0.0001
71091674|NCT03454555|141689761|SUPERIORITY||Odds Ratio (OR)|1.02||||0.96|TWO_SIDED|95.0|0.54|1.9|||Mixed Models Analysis|Used a logistic mixed model for repeated measures||||1.90|0.54|0.96
71091675|NCT03454555|141689762|SUPERIORITY||Odds Ratio (OR)|0.71||||0.28|TWO_SIDED|95.0|0.38|1.33|||Mixed Models Analysis|Used a logistic mixed model for repeated measures||||1.33|0.38|0.28
71091676|NCT03454555|141689763|SUPERIORITY||Odds Ratio (OR)|0.9||||0.75|TWO_SIDED|95.0|0.47|1.71|||Mixed Models Analysis|Used a logistic mixed model for repeated measures||||1.71|0.47|0.75
71091677|NCT03454555|141689764|SUPERIORITY||Odds Ratio (OR)|0.68||||0.25|TWO_SIDED|95.0|0.35|1.31|||Mixed Models Analysis|Used a logistic mixed model for repeated measures||||1.31|0.35|0.25
71091678|NCT03454555|141689765|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.7|TWO_SIDED|95.0|-0.9|1.4|||Mixed Models Analysis|||||1.4|-0.9|0.70
71091679|NCT03454555|141689766|SUPERIORITY||Median Difference (Final Values)|0.1||||0.92|TWO_SIDED|95.0|-1.1|1.2|||Mixed Models Analysis|||||1.2|-1.1|0.92
71091680|NCT03454555|141689767|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.64|TWO_SIDED|95.0|-0.7|1.2|||Mixed Models Analysis|||||1.2|-0.7|0.64
71091681|NCT03454555|141689768|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.75|TWO_SIDED|95.0|-0.8|1.1|||Mixed Models Analysis|||||1.1|-0.8|0.75
71091682|NCT03454555|141689769|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.69|TWO_SIDED|95.0|-0.9|1.4|||Mixed Models Analysis|||||1.4|-0.9|0.69
71091683|NCT03454555|141689770|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.33|TWO_SIDED|95.0|-0.6|1.8|||Mixed Models Analysis|||||1.8|-0.6|0.33
71091684|NCT03454555|141689771|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.86|TWO_SIDED|95.0|-1.8|1.5|||Mixed Models Analysis|||||1.5|-1.8|0.86
71091685|NCT03454555|141689772|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.76|TWO_SIDED|95.0|-1.4|1.9|||Mixed Models Analysis|||||1.9|-1.4|0.76
71091686|NCT03454555|141689773|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.55|TWO_SIDED|95.0|-2.0|1.1|||Mixed Models Analysis|||||1.1|-2.0|0.55
71091687|NCT03454555|141689774|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.52|TWO_SIDED|95.0|-2.1|1.1|||Mixed Models Analysis|||||1.1|-2.1|0.52
71091688|NCT03454555|141689775|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.37|TWO_SIDED|95.0|-0.2|0.4|||Mixed Models Analysis|||||0.4|-0.2|0.37
71091689|NCT03454555|141689776|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.91|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|||||0.3|-0.3|0.91
71091690|NCT03454555|141689777|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.33|TWO_SIDED|95.0|-0.2|0.6|||Mixed Models Analysis|||||0.6|-0.2|0.33
71091691|NCT03454555|141689778|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.46|TWO_SIDED|95.0|-0.3|0.6|||Mixed Models Analysis|||||0.6|-0.3|0.46
71091692|NCT03454555|141689779|SUPERIORITY||Risk Difference (RD)|-0.02||||0.52|TWO_SIDED|95.0|-0.08|0.04|||Chi-squared|||||0.04|-0.08|0.52
71091693|NCT03454555|141689780|SUPERIORITY||Odds Ratio (OR)|1.48||||0.17|TWO_SIDED|95.0|0.85|2.59|||Mixed Models Analysis|Used a generalized logistic model for repeated measurements; modeled the outcome of intention to taper.||||2.59|0.85|0.17
71091694|NCT03454555|141689781|SUPERIORITY||Odds Ratio (OR)|1.28||||0.41|TWO_SIDED|95.0|0.71|2.31|||Mixed Models Analysis|Used a generalized logistic model for repeated measurements; modeled the outcome of intention to taper.||||2.31|0.71|0.41
71091695|NCT03454555|141689782|SUPERIORITY|||||||0.79|||||||Chi-squared|||||||0.79
71091696|NCT03454555|141689783|SUPERIORITY|||||||0.67|||||||Chi-squared|||||||0.67
71091697|NCT03675308|141689829|SUPERIORITY||Response Rate Difference|24.0|||<|0.001|TWO_SIDED|95.0|18.0|30.0||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|The comparison between the risankizumab and placebo treatment groups for the primary efficacy endpoint (ACR20 at Week 24) was performed using the Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factors of baseline psoriasis (≥ 3%/\< 3% body surface area), presence of dactylitis (yes/no), presence of enthesitis (yes/no) and current csDMARD use (0/≥ 1).||30.0|18.0|<0.001
71091698|NCT03675308|141689830|SUPERIORITY||Least Squares (LS) Mean Difference|-0.2|||<|0.001|TWO_SIDED|95.0|-0.26|-0.14||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||-0.14|-0.26|<0.001
71091699|NCT03675308|141689831|SUPERIORITY||Response Rate Difference|42.5|||<|0.001|TWO_SIDED|95.0|35.6|49.3||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||49.3|35.6|<0.001
71091700|NCT03675308|141689832|SUPERIORITY||Response Rate Difference|23.1|||<|0.001|TWO_SIDED|95.0|16.8|29.4||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||29.4|16.8|<0.001
71091701|NCT03675308|141689833|SUPERIORITY||Response Rate Difference|14.8|||<|0.001|TWO_SIDED|95.0|10.2|19.4||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||19.4|10.2|<0.001
71091702|NCT03675308|141689834|SUPERIORITY||LS Mean Difference|-4.19|||<|0.001|TWO_SIDED|95.0|-5.7|-2.68||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||-2.68|-5.70|<0.001
71091703|NCT03675308|141689835|SUPERIORITY||LS Mean Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-0.6|-0.3||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||-0.3|-0.6|<0.001
71091704|NCT03675308|141689836|SUPERIORITY||Response Rate Difference|13.9|||<|0.001|TWO_SIDED|95.0|7.6|20.2||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use and extent of psoriasis at Baseline and study.|Response Rate Difference = Risankizumab - Placebo|The pre-specified analysis for the resolution of enthesitis included pooled data from KEEPsAKE 1 (this study) and KEEPsAKE 2 (M15-998; NCT03671148).||20.2|7.6|<0.001
71091705|NCT03675308|141689837|SUPERIORITY||Response Rate Difference|16.9|||<|0.001|TWO_SIDED|95.0|7.5|26.4||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, extent of psoriasis at Baseline, and study.|Response Rate Difference = Risankizumab - Placebo|The pre-specified analysis for the resolution of dactylitis included pooled data from KEEPsAKE 1 (this study) and KEEPsAKE 2 (M15-998; NCT03671148).||26.4|7.5|<0.001
71091706|NCT03675308|141689838|SUPERIORITY||LS Mean Difference|-0.09||||0.496|TWO_SIDED|95.0|-0.36|0.17||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|ANCOVA|ANCOVA model including treatment and the stratification factors and baseline value as covariates.|Difference = Risankizumab - Placebo|||0.17|-0.36|0.496
71091707|NCT03675308|141689839|OTHER||LS Mean Difference|3.32|||<|0.001|TWO_SIDED|95.0|2.42|4.22||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at the change from Baseline in PsA-mTSS comparison.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||4.22|2.42|<0.001
71091708|NCT03675308|141689840|OTHER||LS Mean Difference|2.6|||<|0.001|TWO_SIDED|95.0|1.5|3.7||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at the change from Baseline in PsA-mTSS comparison.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||3.7|1.5|<0.001
71091709|NCT03675308|141689841|SUPERIORITY||Response Rate Difference|22.2|||<|0.001|TWO_SIDED|95.0|17.3|27.2|||Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||27.2|17.3|<0.001
71152339|NCT01301027|141796831|SUPERIORITY_OR_OTHER|||||||0.047|||||||t-test, 2 sided|||||||0.047
71091710|NCT03675308|141689842|SUPERIORITY||Response Rate Difference|10.5|||<|0.001|TWO_SIDED|95.0|6.9|14.2|||Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||14.2|6.9|<0.001
71091711|NCT04761822|141689909|SUPERIORITY||Risk Difference (RD)|0.026||||0.066|TWO_SIDED|95.0|-0.002|0.06||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.060|-0.002|0.066
71091712|NCT04761822|141689910|SUPERIORITY||Risk Difference (RD)|0.012||||0.267|TWO_SIDED|95.0|-0.016|0.042||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.042|-0.016|0.267
71091713|NCT04761822|141689911|SUPERIORITY||Risk Difference (RD)|0.016||||0.165|TWO_SIDED|95.0|-0.011|0.046||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.046|-0.011|0.165
70907262|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.281||0.5498|TWO_SIDED|95.0|-0.73|0.39|||MMRM|||Anxiety Psychic, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.39|-0.73|0.5498
70907263|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.235||0.2066|TWO_SIDED|95.0|-0.76|0.17|||MMRM|||Anxiety Psychic, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.76|0.2066
70907264|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.23||0.2321|TWO_SIDED|95.0|-0.73|0.18|||MMRM|||Anxiety Psychic, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.73|0.2321
70907265|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.191||0.5582|TWO_SIDED|95.0|-0.49|0.27|||MMRM|||Anxiety Somatic, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.49|0.5582
70907266|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.186||0.2945|TWO_SIDED|95.0|-0.56|0.17|||MMRM|||Anxiety Somatic, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.56|0.2945
70907267|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.208||0.2684|TWO_SIDED|95.0|-0.64|0.18|||MMRM|||Anxiety Somatic, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.64|0.2684
70907268|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.202||0.9396|TWO_SIDED|95.0|-0.42|0.39|||MMRM|||Anxiety Somatic, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.39|-0.42|0.9396
70907269|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.195||0.0283|TWO_SIDED|95.0|-0.82|-0.05|||MMRM|||Anxiety Somatic, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.05|-0.82|0.0283
70907270|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.189||0.1794|TWO_SIDED|95.0|-0.63|0.12|||MMRM|||Anxiety Somatic, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.63|0.1794
71008435|NCT02364999|141524741|OTHER|Hazard ratio of PF-06439535 versus Bevacizumab-EU; a hazard ratio =1 indicated no difference in progressive disease(PD)/death between 2 reporting groups; \>1 indicated an increase in PD/death in PF-06439535; \<1 indicated an increase in PD/death in bevacizumab-EU.|Hazard Ratio (HR)|0.918||||0.4726|TWO_SIDED|95.0|0.729|1.157|||Log Rank|Stratified by smoking, sex and region.||||1.157|0.729|0.4726
70969096|NCT04869345|141443937|SUPERIORITY||Mean Difference (Net)|-2.43|STANDARD_ERROR_OF_MEAN|1.53||0.116|TWO_SIDED|95.0|-5.47|0.61||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Fatigue scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.61|-5.47|0.116
70969097|NCT04869345|141443938|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.08||0.479|TWO_SIDED|95.0|-0.1|0.22||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline CESD-R-10 scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.22|-0.10|0.479
70969098|NCT04869345|141443938|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.08||0.126|TWO_SIDED|95.0|-0.04|0.29||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline CESD-R-10 scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.29|-0.04|0.126
70969099|NCT04869345|141443938|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.09||0.457|TWO_SIDED|95.0|-0.12|0.25||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline CESD-R-10 scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.25|-0.12|0.457
70969100|NCT04869345|141443939|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.13||0.389|TWO_SIDED|95.0|-0.15|0.38||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline mDES scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.38|-0.15|0.389
70969101|NCT04869345|141443939|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.13||0.157|TWO_SIDED|95.0|-0.07|0.46||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline mDES scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.46|-0.07|0.157
70969102|NCT04869345|141443939|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.14||0.593|TWO_SIDED|95.0|-0.21|0.36||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline mDES scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.36|-0.21|0.593
71091714|NCT04761822|141689912|SUPERIORITY||Risk Difference (RD)|0.006||||0.572|TWO_SIDED|95.0|-0.021|0.033||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.033|-0.021|0.572
71091715|NCT04761822|141689913|SUPERIORITY||Risk Difference (RD)|0.016||||0.165|TWO_SIDED|95.0|-0.011|0.046|||Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.046|-0.011|0.165
71091716|NCT04761822|141689914|SUPERIORITY||Risk Difference (RD)|0.006||||0.572|TWO_SIDED|95.0|-0.021|0.033||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.033|-0.021|0.572
71152340|NCT01301027|141796832|SUPERIORITY_OR_OTHER|||||||0.059|||||||t-test, 2 sided|||||||0.059
71152341|NCT01301027|141796833|SUPERIORITY_OR_OTHER|||||||0.508|||||||t-test, 2 sided|||||||0.508
71091717|NCT04761822|141689915|SUPERIORITY||Risk Difference (RD)|0.015||||0.4574|TWO_SIDED|95.0|-0.045|0.055||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the participants that received their first active dose as their first injection proportion minus the participants that received their first active dose as their second injection proportion, is not statistically different from 0 (i.e. there is no difference).||0.055|-0.045|0.4574
71102636|NCT04875533|141713841|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|1.14|||||TWO_SIDED|95.0|0.97|1.34||||||Serotype 33F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||1.34|0.97|
71152342|NCT01301027|141796834|SUPERIORITY_OR_OTHER|||||||0.984|||||||t-test, 2 sided|||||||0.984
71152343|NCT03523988|141796859|SUPERIORITY|||||||0.04||||||P-value for pain scores among the three comparison groups with jaw at rest.|ANOVA|||||||0.04
71152344|NCT03523988|141796859|SUPERIORITY|||||||0.63||||||P-value for pain scores among the three comparison groups while lightly biting.|ANOVA|||||||0.63
70907271|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.188||0.1091|TWO_SIDED|95.0|-0.68|0.07|||MMRM|||Anxiety Somatic, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.68|0.1091
70907272|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.182||0.7921|TWO_SIDED|95.0|-0.41|0.31|||MMRM|||Anxiety Somatic, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.41|0.7921
70907273|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.166||0.0055|TWO_SIDED|95.0|-0.8|-0.14|||MMRM|||Anxiety Somatic, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.14|-0.80|0.0055
70907274|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.161||0.03|TWO_SIDED|95.0|-0.67|-0.03|||MMRM|||Anxiety Somatic, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.67|0.0300
70907275|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.185||0.0118|TWO_SIDED|95.0|-0.84|-0.11|||MMRM|||Anxiety Somatic, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.11|-0.84|0.0118
70907276|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.178||0.2266|TWO_SIDED|95.0|-0.57|0.14|||MMRM|||Anxiety Somatic, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.57|0.2266
70907277|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.181||0.0025|TWO_SIDED|95.0|-0.92|-0.2|||MMRM|||Anxiety Somatic, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.20|-0.92|0.0025
70907278|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.176||0.0555|TWO_SIDED|95.0|-0.69|0.01|||MMRM|||Anxiety Somatic, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.69|0.0555
70907279|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.176||0.0013|TWO_SIDED|95.0|-0.93|-0.23|||MMRM|||Anxiety Somatic, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.23|-0.93|0.0013
70907280|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.171||0.0775|TWO_SIDED|95.0|-0.64|0.03|||MMRM|||Anxiety Somatic, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.64|0.0775
71152345|NCT03523988|141796859|SUPERIORITY|||||||0.41||||||P-value for pain scores among the three comparison groups while chewing paraffin wax.|ANOVA|||||||0.41
71091718|NCT04761822|141689916|SUPERIORITY||Risk Difference (RD)|-0.016||||0.3242|TWO_SIDED|95.0|-0.086|0.018||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the participants that received their first active dose as their first injection proportion minus the participants that received their first active dose as their second injection proportion, is not statistically different from 0 (i.e. there is no difference).||0.018|-0.086|0.3242
71091719|NCT04761822|141689917|SUPERIORITY||Risk Difference (RD)|0.024||||0.31|TWO_SIDED|95.0|-0.037|0.07||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the participants that received their second active dose as their second injection proportion minus the participants that received their second active dose as their third injection proportion, is not statistically different from 0 (i.e. there is no difference).||0.070|-0.037|0.3100
71091720|NCT04761822|141689918|SUPERIORITY||Risk Difference (RD)|-0.007||||0.807|TWO_SIDED|95.0|-0.0783|0.0366||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the participants that received their second active dose as their second injection proportion minus the participants that received their second active dose as their third injection proportion, is not statistically different from 0 (i.e. there is no difference).||0.0366|-0.0783|0.8070
71091721|NCT04761822|141689919|SUPERIORITY||Risk Difference (RD)|0.001||||1|TWO_SIDED|95.0|-0.04|0.042||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the Pfizer-BioNTech COVID-19 vaccine first injection proportion minus comparison placebo first injection proportion, is not statistically different from 0 (i.e. there is no difference).||0.042|-0.040|1.000
71091722|NCT04761822|141689920|SUPERIORITY||Risk Difference (RD)|-0.015||||0.25|TWO_SIDED|95.0|-0.053|0.018||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the Moderna COVID-19 vaccine first injection proportion minus comparison placebo first injection proportion, is not statistically different from 0 (i.e. there is no difference).||0.018|-0.053|0.250
71091723|NCT04761822|141689921|SUPERIORITY||Risk Difference (RD)|0.058||||0.004|TWO_SIDED|95.0|0.024|0.101||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.101|0.024|0.004
71091724|NCT04761822|141689922|SUPERIORITY||Risk Difference (RD)|0.075|||<|0.001|TWO_SIDED|95.0|0.039|0.124||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.124|0.039|<0.001
71091725|NCT02385318|141689940|EQUIVALENCE|85% power of success|Equivalence ratio|1.11|||||TWO_SIDED|90.0|-4.38|14.44|||Yates correction|||||14.44|-4.38|
71091726|NCT00248560|141689941|SUPERIORITY_OR_OTHER||Response rate|0.17|||||TWO_SIDED|95.0|0.08|0.32||||||||0.32|0.08|
71091727|NCT02326883|141689959|SUPERIORITY||Cox Proportional Hazard|1.07|STANDARD_ERROR_OF_MEAN|0.12||0.61|TWO_SIDED|95.0|0.86|1.33||A priori two-sided comparison of Care Management condition to Usual Care|Log Rank|A priori Bonferonni-corrected threshold for statistical significance was 0.025.|To clarify direction of comparison: relative hazard of suicide attempt among participants assigned to Care Management was 1.07 (95% CI 0.86 - 1.33) higher compared to participants assigned to Usual Care|Comparison of participants assigned to Care Management intervention to those assigned to continued Usual Care||1.33|0.86|0.61
71091728|NCT02326883|141689959|SUPERIORITY|A priori two-sided comparison of Skills Training to usual care.|Cox Proportional Hazard|1.29|STANDARD_ERROR_OF_MEAN|0.14||0.02|TWO_SIDED|95.0|1.05|1.59||A priori Bonferonni-corrected threshold for statistical significance was 0.025.|Log Rank||To clarify direction of comparison: relative hazard of suicide attempt in participants assigned to Skills Training was 1.29 (95% CI 1.05-1.59) times higher than in those assigned to Usual Care|Comparison of Skills Training to Usual Care||1.59|1.05|0.02
70969103|NCT04869345|141443940|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.13||0.933|TWO_SIDED|95.0|-0.26|0.24||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PANAS-GEN scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.24|-0.26|0.933
70969104|NCT04869345|141443940|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.13||0.642|TWO_SIDED|95.0|-0.19|0.31||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PANAS-GEN scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.31|-0.19|0.642
71091729|NCT02469857|141690003|SUPERIORITY|||||||0.135|||||||Chi-squared|||This analysis utilized the mITT analysis population.||||0.135
71091730|NCT02469857|141690003|SUPERIORITY|||||||0.025|||||||Chi-squared|||This analysis utilized the US-mITT analysis population.||||0.025
71091731|NCT02469857|141690007|SUPERIORITY|||||||0.069|||||||Chi-squared|||||||0.069
71091732|NCT02469857|141690008|SUPERIORITY|||||||0.401|||||||Wilcoxon (Mann-Whitney)|||||||0.401
71091733|NCT02469857|141690009|SUPERIORITY|||||||0.195|||||||Wilcoxon (Mann-Whitney)|||||||0.195
71091734|NCT02469857|141690010|SUPERIORITY|||||||0.596|||||||Wilcoxon (Mann-Whitney)|||||||0.596
71091735|NCT02469857|141690011|SUPERIORITY|||||||0.512|||||||Wilcoxon (Mann-Whitney)|||||||0.512
70969105|NCT04869345|141443940|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.12||0.577|TWO_SIDED|95.0|-0.18|0.32||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PANAS-GEN scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.32|-0.18|0.577
70969106|NCT04869345|141443941|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.11||0.403|TWO_SIDED|95.0|-0.32|0.13||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PSS scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.13|-0.32|0.403
70969107|NCT04869345|141443941|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.11||0.062|TWO_SIDED|95.0|-0.44|0.01||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS PSS scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.01|-0.44|0.062
70969108|NCT04869345|141443941|SUPERIORITY||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.11||0.269|TWO_SIDED|95.0|-0.33|0.09||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PSS scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.09|-0.33|0.269
70969109|NCT04869345|141443942|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.07||0.003|TWO_SIDED|95.0|0.07|0.33||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 11 minus Baseline) minus the change for the Attention Control (Week 11 minus Baseline).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Baseline to Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.33|0.07|0.003
70969110|NCT04869345|141443942|SUPERIORITY||Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.07||0.006|TWO_SIDED|95.0|0.05|0.31||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Baseline) minus the change for the Attention Control (Week 16 minus Baseline).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Baseline to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.31|0.05|0.006
70969111|NCT04869345|141443942|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.796|TWO_SIDED|95.0|-0.15|0.12||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.12|-0.15|0.796
71008705|NCT02055976|141525244|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.826|STANDARD_ERROR_OF_MEAN|2.878|<|0.001|TWO_SIDED|95.0|4.103|15.548|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||15.548|4.103|<0.001
71091736|NCT02469857|141690012|SUPERIORITY|||||||0.033|||||||Chi-squared|||||||0.033
71091737|NCT02469857|141690013|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.554|TWO_SIDED|95.0|0.5|1.46|||Log Rank|||||1.46|0.50|0.554
71091738|NCT02469857|141690014|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.148|TWO_SIDED|95.0|0.23|1.26|||Log Rank|||||1.26|0.23|0.148
70969112|NCT04869345|141443943|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.758|TWO_SIDED|95.0|-0.03|0.05||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 11 minus Baseline) minus the change for the Attention Control (Week 11 minus Baseline).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Baseline to Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.05|-0.03|0.758
70969113|NCT04869345|141443943|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.88|TWO_SIDED|95.0|-0.04|0.04||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Baseline) minus the change for the Attention Control (Week 16 minus Baseline).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Baseline to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.04|-0.04|0.880
70969114|NCT04869345|141443943|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.652|TWO_SIDED|95.0|-0.05|0.03||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.03|-0.05|0.652
70969115|NCT01999465|141444025|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|We applied Wilcoxon-Mann Whitney test with the Null hypothesis that there is no difference between 2 arms.||||||0.40
70969116|NCT01999465|141444026|OTHER|||||||0.2|||||||t-test, 2 sided|||||||0.20
70969117|NCT01308008|141444091|SUPERIORITY||coefficient|0.05||||0.16|TWO_SIDED|95.0|-0.02|0.13|||Regression, Logistic|||||0.13|-0.02|0.16
70969118|NCT01308008|141444092|SUPERIORITY||coefficient|34.0||||0.17|TWO_SIDED|95.0|-15.0|83.0|||Regression, Logistic|||||83|-15|0.17
70969119|NCT01308008|141444093|SUPERIORITY||coefficient|-8.7||||0.5|TWO_SIDED|95.0|-35.0|17.0|||Regression, Logistic|||||17|-35|0.5
70969120|NCT01761084|141444104|SUPERIORITY||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.58|1.94||||||||1.94|.58|
70969121|NCT01761084|141444105|SUPERIORITY||Risk Ratio (RR)|1.32|||||TWO_SIDED|95.0|0.99|1.74||||||||1.74|.99|
70969122|NCT01761084|141444106|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.811|TWO_SIDED|95.0|-0.84|1.07|||t-test, 2 sided|Intention-to-treat analysis|Intention-to-treat analysis|Baseline||1.07|-0.84|0.811
70969123|NCT01761084|141444106|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.765|TWO_SIDED|95.0|-0.8|1.09|||t-test, 2 sided||Per-protocol analysis|Month 12||1.09|-0.80|0.765
71091739|NCT02469857|141690015|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.736|TWO_SIDED|95.0|0.46|1.73|||Log Rank|||||1.73|0.46|0.736
70969124|NCT01761084|141444107|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.796|TWO_SIDED|95.0|-0.8|0.61|||t-test, 2 sided||Intention-to-treat analysis|Baseline||0.61|-0.80|0.796
70969125|NCT01761084|141444107|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.888|TWO_SIDED|95.0|-0.75|0.65|||t-test, 2 sided||Per-protocol analysis|Month 12||0.65|-0.75|0.888
70969126|NCT01761084|141444108|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.719|TWO_SIDED|95.0|-0.54|0.78|||t-test, 2 sided||Intention-to-treat analysis|Baseline||0.78|-0.54|0.719
70969127|NCT01761084|141444108|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.745|TWO_SIDED|95.0|-0.56|0.79|||t-test, 2 sided||Per-protocol analysis|Month 12||0.79|-0.56|0.745
70969128|NCT01761084|141444109|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.854|TWO_SIDED|95.0|-5.66|6.83|||t-test, 2 sided||Intention-to-treat analysis|Comparison of change from baseline in EQ5D - VAS||6.83|-5.66|0.854
70969129|NCT01761084|141444109|SUPERIORITY||Mean Difference (Final Values)|1.78||||0.585|TWO_SIDED|95.0|-4.66|8.22|||t-test, 2 sided||Per-protocol analysis|Comparison of change from baseline in EQ5D-VAS||8.22|-4.66|0.585
70969130|NCT01761084|141444109|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.335|TWO_SIDED|95.0|-0.16|0.47|||t-test, 2 sided||Intention-to-treat analysis|Comparison of change from baseline in OQLQ Average Score||0.47|-0.16|0.335
70969131|NCT01761084|141444109|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.285|TWO_SIDED|95.0|-0.15|0.5|||t-test, 2 sided||Per-protocol analysis|Comparison of change from baseline in OQLQ Average Score||0.50|-0.15|0.285
70969132|NCT01761084|141444109|SUPERIORITY||Mean Difference (Final Values)|-0.52||||0.225|TWO_SIDED|95.0|-1.36|0.32|||t-test, 2 sided||Intention-to-treat analysis|Comparison of change from baseline in pain VAS at rest||0.32|-1.36|0.225
70969133|NCT01761084|141444109|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.488|TWO_SIDED|95.0|-1.16|0.56|||t-test, 2 sided||Per-protocol analysis|Comparison of change from baseline in pain VAS at rest||0.56|-1.16|0.488
70969134|NCT01761084|141444109|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.808|TWO_SIDED|95.0|-0.68|0.88|||t-test, 2 sided||Intention-to-treat analysis|Comparison of change from baseline in pain VAS during movement||0.88|-0.68|0.808
71091740|NCT02469857|141690016|SUPERIORITY||Hazard Ratio (HR)|0.34||||0.093|TWO_SIDED|95.0|0.09|1.25|||Log Rank|||||1.25|0.09|0.093
71091741|NCT02469857|141690017|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.352|TWO_SIDED|95.0|0.35|1.46|||Log Rank|||||1.46|0.35|0.352
70969135|NCT01761084|141444109|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.566|TWO_SIDED|95.0|-0.57|1.04|||t-test, 2 sided||Per-protocol analysis|Comparison of change from baseline in pain VAS during movement||1.04|-0.57|0.566
70969136|NCT01761084|141444112|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.951|TWO_SIDED|95.0|-1.412|1.501|||t-test, 2 sided|||Baseline||1.501|-1.412|.951
70969137|NCT01761084|141444112|SUPERIORITY||Mean Difference (Final Values)|-1.396||||0.039|TWO_SIDED|95.0|-2.721|-0.071|||t-test, 2 sided|||Month 12||-0.071|-2.721|0.039
70969138|NCT01761084|141444113|SUPERIORITY||Mean Difference (Final Values)|-65.9|||<|0.05|TWO_SIDED|95.0|-91.8|-40.0||Month 6 strength and balance physical activity|t-test, 2 sided|||Only Month 6 and Month 12 strength and balance physical activity differences were significant.||-40.0|-91.8|<0.05
70969139|NCT01761084|141444113|SUPERIORITY||Mean Difference (Final Values)|-49.3|||<|0.05|TWO_SIDED|95.0|-69.8|-28.8||Month 12 strength and balance physical activity|t-test, 2 sided|||Only Month 6 and Month 12 strength and balance physical activity differences were significant.||-28.8|-69.8|<0.05
70969140|NCT01761084|141444118|SUPERIORITY||Incident Rate Ratio|0.97|||||TWO_SIDED|95.0|0.58|1.63||||||Negative Binomial Regression.||1.63|.58|
70969141|NCT01761084|141444121|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.536|TWO_SIDED|95.0|-0.28|0.53|||t-test, 2 sided||Intention-to-treat analysis|Comparison of change from baseline in height||0.53|-0.28|0.536
70969142|NCT01761084|141444122|SUPERIORITY||Mean Difference (Net)|-0.055||||0.9|TWO_SIDED|95.0|-0.917|0.807|||t-test, 2 sided|||Month 12 scores.||0.807|-0.917|.900
70969143|NCT01761084|141444123|SUPERIORITY||Mean Difference (Final Values)|-5.2|STANDARD_ERROR_OF_MEAN|13.9||0.712|TWO_SIDED|95.0|-33.6|23.2|||t-test, 2 sided|||Baseline||23.2|-33.6|.712
70969144|NCT01761084|141444123|SUPERIORITY||Mean Difference (Final Values)|8.1|STANDARD_ERROR_OF_MEAN|15.3||0.6|TWO_SIDED|95.0|-23.3|39.5|||t-test, 1 sided|||Month 12||39.5|-23.3|.60
70969145|NCT01761084|141444125|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.461|TWO_SIDED|95.0|-0.25|0.55|||t-test, 2 sided||Per-protocol analysis|Comparison of change from baseline in weight||0.55|-0.25|0.461
70969146|NCT00940589|141444127|SUPERIORITY_OR_OTHER||||||<|0.045|TWO_SIDED||||||ANCOVA|||||||<0.045
70969147|NCT00940589|141444128|SUPERIORITY_OR_OTHER||||||<|0.044|TWO_SIDED||||||ANCOVA|||||||<0.044
70969148|NCT01261507|141444135|SUPERIORITY_OR_OTHER||difference in areas under the LROC curve|-0.059|STANDARD_ERROR_OF_MEAN|0.037|<|0.05|TWO_SIDED|95.0|-0.086|-0.031|||mixed model:Dorfman, Berbaum, Metz|||Measure is the difference between the radiologists working without the software less the value for the radiologists working with the software. Thus a negative value would indicate that the the radiologists showed better results when using the software.||-0.031|-0.086|<0.05
70969149|NCT04962022|141444138|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir co-administered with itraconazole was the Test treatment.|Specified in comments|118.57||||0.05|TWO_SIDED|90.0|112.5|124.97|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of geometric means 2.90% CI of ratio of geometric means"|||124.97|112.50|0.05
70969150|NCT04962022|141444139|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir co-administered with itraconazole was the Test treatment.|Specified in comments|138.82||||0.05|TWO_SIDED|90.0|129.25|149.11|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of geometric means 2.90% CI of ratio of geometric means"|||149.11|129.25|0.05
70969151|NCT01146873|141444158|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis is that efavirenz is inferior to ritonavir-boosted lopinavir.|Risk Difference (RD)|0.107|||<|0.001|TWO_SIDED||||||Kaplan-Meier methods|||||||<0.001
70969152|NCT01146873|141444159|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis is that efavirenz is inferior to ritonavir-boosted lopinavir.|Risk Difference (RD)|-0.007|||<|0.001|TWO_SIDED||||||Kaplan-Meier methods|||||||<0.001
70969153|NCT01146873|141444160|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
70969154|NCT01146873|141444162|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Chi-squared|||||||0.003
70969155|NCT01389752|141444201|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.65|||||TWO_SIDED|90.0|0.61|0.68||The outcome was measured as a ratio of geometric means between the two treatments (LY2216684 in combination with activated charcoal/LY2216684 alone), and the 90% Confidence Interval for the ratio.|Mixed Models Analysis|||||0.68|0.61|
70969156|NCT01389752|141444202|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.9|||||TWO_SIDED|90.0|0.83|0.98||The outcome was measured as a ratio of geometric means between the two treatments (LY2216684 in combination with activated charcoal/LY2216684 alone), and the 90% Confidence Interval for the ratio.|Mixed Models Analysis|||||0.98|0.83|
70969157|NCT01389752|141444203|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.55||||0.001|TWO_SIDED|90.0|-1.04|-0.5||The outcome was measured using the median of paired differences between the 2 treatment groups: LY2216684 administered alone (reference) versus LY2216684 co-administered with charcoal (test).|Wilcoxon (Mann-Whitney)|||||-0.50|-1.04|0.0010
70969158|NCT01594515|141444221|SUPERIORITY_OR_OTHER||Slope|0.9702|STANDARD_ERROR_OF_MEAN|0.0151|||TWO_SIDED|95.0|0.94|1.0005|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose). Dose proportionality of the drug for Cmax was analysed.(N=50)||1.0005|0.9400|
70969159|NCT01594515|141444222|SUPERIORITY_OR_OTHER||Slope|1.0442|STANDARD_ERROR_OF_MEAN|0.0148|||TWO_SIDED|95.0|1.0145|1.074|||||"Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1.~PK endpoints on the log-transformed scale."|This was non confirmatory testing (Single dose). Dose proportionality of the drug for AUC0-inf was analysed. (N=48)||1.0740|1.0145|
70969160|NCT04251910|141444228|SUPERIORITY|||||||0.0813|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (2 hours)||||0.0813
70969161|NCT04251910|141444228|SUPERIORITY|||||||0.0011|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (2 hours)||||0.0011
70969162|NCT04251910|141444228|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (2 hours)||||0.0002
70969163|NCT04251910|141444230|SUPERIORITY|||||||0.9616|||||||Mixed effects model|||Part A 30 mcg BXCL501 v/s Part A-Placebo (30 minutes)||||0.9616
70969164|NCT04251910|141444230|SUPERIORITY|||||||0.546|||||||Mixed effects model|||Part A-30 mcg BXCL501 v/s Part A-Placebo (Day 1; 1 hour)||||0.5460
70969165|NCT04251910|141444230|SUPERIORITY|||||||0.0961|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/s Part A-Placebo (2 hours)||||0.0961
70969166|NCT04251910|141444230|SUPERIORITY|||||||0.1359|||||||Mixed effects model|||Part A-30 mcg BXCL501 v/s Part A-Placebo (4 hours)||||0.1359
70969167|NCT04251910|141444230|SUPERIORITY|||||||0.1688|||||||Mixed effects model|||Part A-30 mcg BXCL501 v/s Part A-Placebo (8 hours)||||0.1688
70969168|NCT04251910|141444230|SUPERIORITY|||||||0.667|||||||Mixed effects model|||Part A-30 mcg BXCL501 v/s Part A-Placebo (24 hours)||||0.6670
70969169|NCT04251910|141444230|SUPERIORITY|||||||0.8695|||||||Mixed effects model|||Part A-30 mcg BXCL501 v/s Part A-Placebo (Day 3)||||0.8695
70969170|NCT04251910|141444230|SUPERIORITY|||||||0.5002|||||||Mixed effects model|||Part A-30 mcg BXCL501 v/s Part A-Placebo (Day 7)||||0.5002
70969171|NCT04251910|141444230|SUPERIORITY|||||||0.5631|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (30 minutes)||||0.5631
70969172|NCT04251910|141444230|SUPERIORITY|||||||0.0089|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (1 hour)||||0.0089
70969173|NCT04251910|141444230|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (2 hours)||||<.0001
70969174|NCT04251910|141444230|SUPERIORITY|||||||0.0011|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (4 hours)||||0.0011
70969175|NCT04251910|141444230|SUPERIORITY|||||||0.0008|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (8 hours)||||0.0008
70969176|NCT04251910|141444230|SUPERIORITY|||||||0.2847|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (24 hours)||||0.2847
70969177|NCT04251910|141444230|SUPERIORITY|||||||0.2616|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (Day 3)||||0.2616
70969178|NCT04251910|141444230|SUPERIORITY|||||||0.1989|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (Day 7)||||0.1989
70969179|NCT04251910|141444230|SUPERIORITY|||||||0.4585|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (30 minutes)||||0.4585
70969180|NCT04251910|141444230|SUPERIORITY|||||||0.0005|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (1 hour)||||0.0005
70969181|NCT04251910|141444230|SUPERIORITY|||||||0.0004|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (2 hours)||||0.0004
70969182|NCT04251910|141444230|SUPERIORITY|||||||0.0025|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (4 hours)||||0.0025
70969183|NCT04251910|141444230|SUPERIORITY|||||||0.1027|TWO_SIDED|95.0|||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (8 hours)||||0.1027
70969184|NCT04251910|141444230|SUPERIORITY|||||||0.7953|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (24 hours)||||0.7953
70969185|NCT04251910|141444230|SUPERIORITY|||||||0.1416|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 3)||||0.1416
70969186|NCT04251910|141444230|SUPERIORITY|||||||0.0658|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 7)||||0.0658
70969187|NCT04251910|141444231|SUPERIORITY|||||||0.876|||||||Mixed effects model|||Part A -30 mcg BXCL501 v/s Part A-Placebo (Day 1; 1 hour)||||0.8760
70969188|NCT04251910|141444231|SUPERIORITY|||||||0.9077|||||||Mixed effects model|||Part A 30 mcg BXCL501 v/s Part A-Placebo (Day 1; 2 hours)||||0.9077
70969189|NCT04251910|141444231|SUPERIORITY|||||||0.7208|||||||Mixed effects model|||Part A 30 mcg BXCL501 vs Part A-Placebo (Day1; 4 hours)||||0.7208
70969190|NCT04251910|141444231|SUPERIORITY|||||||0.3666|||||||Mixed effects model|||Part A BXCL501 30 mcg v/s Part A-Placebo(Day 1;8 hours)||||0.3666
70969191|NCT04251910|141444231|SUPERIORITY|||||||0.0191|||||||Mixed effects model|||Part A BXCL501 60 mcg v/s Placebo-Part A (Day1; 1 hour)||||0.0191
70969192|NCT04251910|141444231|SUPERIORITY|||||||0.0006|||||||Mixed effects model|||Part A BXCL501 60 mcg v/s Part A-Placebo (Day 1; 2 hours)||||0.0006
70969193|NCT04251910|141444231|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (Day 1; 4 hours)||||<.0001
70969194|NCT04251910|141444231|SUPERIORITY|||||||0.0003|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1;8 hours)||||0.0003
70969195|NCT04251910|141444231|SUPERIORITY|||||||0.0006|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 1 hour)||||0.0006
70969196|NCT04251910|141444231|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 2 hours)||||0.0002
70969197|NCT04251910|141444231|SUPERIORITY|||||||0.0029|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 4 hours)||||0.0029
70969198|NCT04251910|141444231|SUPERIORITY|||||||0.2446|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 8 hours)||||0.2446
70969199|NCT04251910|141444232|SUPERIORITY|||||||0.0926|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 30 minutes)||||0.0926
70969200|NCT04251910|141444232|SUPERIORITY|||||||0.3976|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 1 hour)||||0.3976
70969201|NCT04251910|141444232|SUPERIORITY|||||||0.1169|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 4 hours)||||0.1169
70969202|NCT04251910|141444232|SUPERIORITY|||||||0.3786|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 8 hours)||||0.3786
70969203|NCT04251910|141444232|SUPERIORITY|||||||0.564|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 2; 24hours)||||0.5640
70969204|NCT04251910|141444232|SUPERIORITY|||||||0.602|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 3)||||0.6020
70969205|NCT04251910|141444232|SUPERIORITY|||||||0.5875|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 7)||||0.5875
70969206|NCT04251910|141444232|SUPERIORITY|||||||0.1055|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 30 minutes)||||0.1055
70969207|NCT04251910|141444232|SUPERIORITY|||||||0.0024|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 1 hour)||||0.0024
70969208|NCT04251910|141444232|SUPERIORITY|||||||0.0016|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 4 hours)||||0.0016
70969209|NCT04251910|141444232|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 8 hours)||||0.0002
70969210|NCT04251910|141444232|SUPERIORITY|||||||0.2039|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 2; 24 hours)||||0.2039
70969211|NCT04251910|141444232|SUPERIORITY|||||||0.1948|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 3)||||0.1948
70969212|NCT04251910|141444232|SUPERIORITY|||||||0.5615|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 7)||||0.5615
70969213|NCT04251910|141444232|SUPERIORITY|||||||0.8266|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 30 minutes)||||0.8266
70969214|NCT04251910|141444232|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 1 hour)||||0.0002
70969215|NCT04251910|141444232|SUPERIORITY|||||||0.0004|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 4 hours)||||0.0004
70969216|NCT04251910|141444232|SUPERIORITY|||||||0.1037|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 8 hours)||||0.1037
70969217|NCT04251910|141444232|SUPERIORITY|||||||0.3267|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 2; 24 hours)||||0.3267
70969218|NCT04251910|141444232|SUPERIORITY|||||||0.0339|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 3)||||0.0339
70969219|NCT04251910|141444232|SUPERIORITY|||||||0.1892|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day7)||||0.1892
70969220|NCT04251910|141444233|SUPERIORITY|||||||0.3359|||||||Fisher Exact|||Part A-30 mcg BXCL501 V/S Part A-Placebo (2 hours post administration)||||0.3359
70969221|NCT04251910|141444233|SUPERIORITY|||||||0.0004|||||||Fisher Exact|||Part A-60 mcg BXCL501 V/S Part A-Placebo (2 hours post administration)||||0.0004
70969222|NCT04251910|141444233|SUPERIORITY|||||||0.0351|||||||Fisher Exact|||||||0.0351
70969223|NCT04251910|141444234|SUPERIORITY|||||||0.0952|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (2 hours)||||0.0952
70969224|NCT04251910|141444234|SUPERIORITY|||||||0.8977|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 2; 24 hours)||||0.8977
70969225|NCT04251910|141444234|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 2 hours)||||0.0002
70969226|NCT04251910|141444234|SUPERIORITY|||||||0.3147|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 2; 24 hours)||||0.3147
70969227|NCT04251910|141444234|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 2 hours)||||<.0001
70969228|NCT04251910|141444234|SUPERIORITY|||||||0.1241|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 2; 24 hours)||||0.1241
70969229|NCT04251910|141444235|SUPERIORITY|||||||0.408|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 30 minutes)||||0.4080
70969230|NCT04251910|141444235|SUPERIORITY|||||||0.4198|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 1 hour)||||0.4198
70969231|NCT04251910|141444235|SUPERIORITY|||||||0.037|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day1; 2 hours)||||0.0370
70969232|NCT04251910|141444235|SUPERIORITY|||||||0.1324|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 4 hours)||||0.1324
70969233|NCT04251910|141444235|SUPERIORITY|||||||0.0624|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 8 hours)||||0.0624
70969234|NCT04251910|141444235|SUPERIORITY|||||||0.6334|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 30 minutes)||||0.6334
70969235|NCT04251910|141444235|SUPERIORITY|||||||0.0275|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 1 hour)||||0.0275
70969236|NCT04251910|141444235|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 2 hours)||||<.0001
70969237|NCT04251910|141444235|SUPERIORITY|||||||0.0001|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 4 hours)||||0.0001
70969238|NCT04251910|141444235|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day1; 8 hours)||||<.0001
70969239|NCT04251910|141444235|SUPERIORITY|||||||0.2806|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 30 minutes)||||0.2806
70969240|NCT04251910|141444235|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 1 hour)||||0.0002
70969241|NCT04251910|141444235|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 2 hour)||||<.0001
70969242|NCT04251910|141444235|SUPERIORITY|||||||0.0009|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 4 hours)||||0.0009
70969243|NCT04251910|141444235|SUPERIORITY|||||||0.0081|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 8 hours)||||0.0081
70969244|NCT04251910|141444236|SUPERIORITY|||||||0.0591|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 2 hours)||||0.0591
70969245|NCT04251910|141444236|SUPERIORITY|||||||0.0966|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 7)||||0.0966
70969246|NCT04251910|141444236|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 2 hours)||||<.0001
70969247|NCT04251910|141444236|SUPERIORITY|||||||0.029|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 7)||||0.0290
70969248|NCT04251910|141444236|SUPERIORITY|||||||0.0937|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 2 hours)||||0.0937
70969249|NCT04251910|141444236|SUPERIORITY|||||||0.2747|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 7)||||0.2747
70969250|NCT04251910|141444239|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (2 hours post administration)||||0.0002
70969251|NCT03002155|141444249|SUPERIORITY|||||||0.26||||||Not adjusted for multiple comparisons due to the pilot nature of the study, alpha level was 0.10.|ANOVA|||||||.26
70969252|NCT03002155|141444250|SUPERIORITY|||||||0.38|||||||ANOVA|||||||0.38
70969253|NCT03002155|141444251|SUPERIORITY|||||||0.24|||||||ANOVA|||For PROMIS Global Physical||||0.24
70969254|NCT03002155|141444251|SUPERIORITY|||||||0.8||||||p-value is interaction of group and time. Alpha level= 0.10; not adjusted for multiple comparisons (pilot study)|ANOVA|||For PROMIS Global Mental||||0.80
70969255|NCT03002155|141444252|SUPERIORITY|||||||0.81||||||p-value is interaction of group and time. Alpha level= 0.10; not adjusted for multiple comparisons (pilot study)|ANOVA|||||||0.81
70969256|NCT03002155|141444253|SUPERIORITY|||||||0.03||||||p-value is interaction of group and time. Alpha level= 0.10; not adjusted for multiple comparisons (pilot study)|ANOVA|||||||0.03
70969257|NCT00978029|141444259|SUPERIORITY_OR_OTHER||Percent Difference|6.9||||0.486|TWO_SIDED|95.0|-10.17|23.97|||Fisher Exact|||||23.97|-10.17|0.486
70969258|NCT00978029|141444259|SUPERIORITY_OR_OTHER||Percent Difference|16.9||||0.078|TWO_SIDED|95.0|0.01|33.83|||Fisher Exact|||||33.83|0.01|0.078
70969259|NCT00841789|141444281|SUPERIORITY|||||||0.1|||||||Chi-squared|||||||.10
70969260|NCT00841789|141444282|SUPERIORITY|||||||0.86|||||||Regression, Cox|||We applied a Generalized Estimating Equation (GEE) model to determine z score change values (see Protocol page 36 in Supplement).||||0.86
71091742|NCT02469857|141690018|SUPERIORITY||Hazard Ratio (HR)|0.21||||0.031|TWO_SIDED|95.0|0.04|0.99|||Log Rank|||||0.99|0.04|0.031
71091743|NCT02469857|141690019|SUPERIORITY|||||||0.024|||||||Chi-squared|||||||0.024
71091744|NCT02469857|141690020|SUPERIORITY|||||||0.007|||||||Chi-squared|||||||0.007
71091745|NCT02469857|141690021|SUPERIORITY|||||||0.034|||||||Chi-squared|||||||0.034
71091746|NCT02469857|141690022|SUPERIORITY|||||||0.003|||||||Chi-squared|||||||0.003
71091747|NCT02110693|141690023|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Alcohol Use Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.7|||||TWO_SIDED|95.0|0.64|0.75||||||Each administration approach (interviewer and tablet) was tested separately against the reference measure.||.75|.64|
71091748|NCT02110693|141690023|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Alcohol Use Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.74|||||TWO_SIDED|95.0|0.68|0.79||||||Each administration approach (interviewer and tablet) was tested separately against the reference measure.||.79|.68|
71091749|NCT02110693|141690024|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Cannabis Use Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.71|||||TWO_SIDED|95.0|0.63|0.79||||||Each administration approach (interviewer and tablet) were separately tested against the reference measure.||.79|.63|
71091750|NCT02110693|141690024|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Cannabis Use Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.7|||||TWO_SIDED|95.0|0.62|0.77||||||Each administration approach (interviewer and tablet) were separately tested against the reference measure.||.77|.62|
71091751|NCT02110693|141690025|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Cocaine and Amphetamine (Stimulant) Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.57|||||TWO_SIDED|95.0|0.47|0.67||||||Each administration approach (interviewer and tablet) were tested separately against the reference measure.||.67|.47|
71091752|NCT02110693|141690025|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Cocaine and Amphetamine (Stimulant) Use Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.6|||||TWO_SIDED|95.0|0.5|0.69||||||Each administration approach (interviewer and tablet) were separately tested against the reference measure.||.69|.50|
71091753|NCT02110693|141690026|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Heroin Use Disorder using receiver operator characteristic (ROC) curves.|sensivity|0.66|||||TWO_SIDED|95.0|0.53|0.77||||||Each administration approach (interviewer and tablet) were tested separately against the reference measure.||.77|.53|
71091754|NCT02110693|141690026|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Heroin Use Disorder using receiver operator characteristic (ROC) curves.|Sensivity|0.66|||||TWO_SIDED|95.0|0.53|0.77||||||Each administration approach (interviewer and tablet) were tested separately against the reference measure.||.77|.53|
70969261|NCT00841789|141444283|SUPERIORITY|||||||0.83|||||||GEE|||General Estimating Equation||||.83
70969262|NCT00841789|141444283|OTHER|Generallzed Estimating Equation was used for z-score change within groups compared to baseline|General Estimating Equation|||||0.1279|||||||GEE|||We analyzed change from baseline for both etanercept and placebo. LS mean change J(standard error) reported||||0.1279
71091755|NCT02110693|141690030|OTHER|The association on the interviewer and tablet computer administered versions of the TAPS Tool compared to the reference standard AUDIT-C score was assessed using Spearman Correlation.|Spearman Correlation|0.63|||||TWO_SIDED|95.0|0.59|0.66|||||The estimated value is a Spearman Correlation point estimate between TAPS Tool Alcohol Score and the AUDIT-C score. A Confidence Interval rather than a dispersion value is therefore reported.|Each administration approach (interviewer and tablet) were tested separately against the reference measure.||.66|.59|
71091756|NCT02110693|141690030|OTHER|The association on the interviewer and tablet administered versions of the TAPS Tool compared to the reference standard of the AUDIT C score was assessed using Spearman Correlation.|Spearman Correlation|0.64|||||TWO_SIDED|95.0|0.61|0.68|||||The estimated value is a Spearman Correlation point estimate between TAPS Tool Alcohol Score and the AUDIT-C Score. A Confidence Interval rather than a dispersion value is therefore reported.|Each administration approach (interviewer and tablet) was tested separately against the reference measure.||.68|.61|
71091757|NCT02110693|141690032|OTHER|The association on the interviewer and tablet computer administered versions of the TAPS Tool compared to the reference standard Smokeless Tobacco Questionnaire was assessed using Spearman Correlation.|Spearman Correlation|0.29|||||TWO_SIDED|95.0|0.25|0.33|||||The estimated value is a Spearman Correlation point estimate between the TAPS Tool Tobacco Score and the Smokeless Tobacco Questionnare. Confidence Interval rather than a dispersion value is therefore reported.|Each administration approach (interviewer and tablet computer) was tested separately against the reference measure.||.33|.25|
71091758|NCT02110693|141690032|OTHER||Spearman Correlation|0.28|||||TWO_SIDED|95.0|0.24|0.32|||||The estimated value is a Spearman Correlation point estimate between TAPS Tool Tobacco Score and the score on the Smokeless Tobacco Questionnaire. A Confidence Interval rather than a dispersion value is therefore reported.|Each administration approach (interviewer and tablet) were tested separately against the reference measure.||.32|.24|
70969263|NCT00841789|141444284|OTHER|General Estimating Equation for 3 coronary arteries.||||||0.03|||||||GEE|||General Estimating Equation|Generalize estimating equation for 3 coronary arteries evaluated in each patient by echocardiography|||0.03
70969264|NCT00841789|141444284|OTHER|see above||||||0.619|||||||GEE|||GEE performed to compare with change in coronary z score from baseline||||0.619
70969265|NCT03317795|141444320|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
70969266|NCT03317795|141444322|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
70969267|NCT03317795|141444323|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||Physical composite score||||0.32
70969268|NCT03317795|141444323|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||Mental composite score||||0.26
70969269|NCT03317795|141444324|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
71091759|NCT02110693|141690033|OTHER|The association on the interviewer and tablet computer administered versions of the TAPS Tool compared to the reference standard of the results of the oral fluid test was assessed using Spearman Correlation.|Spearman Correlation|0.42|||||TWO_SIDED|95.0|0.35|0.48|||||The estimated value is a Spearman Correlation point estimate between TAPS Tool Cannabis Score and the results of the Oral Fluid Test. Confidence Interval rather than a dispersion value is therefore reported.|Each administration approach (interviewer and tablet) were tested separately against the reference measure.||.48|.35|
71091760|NCT02110693|141690033|OTHER||Spearman Correlation|0.4|||||TWO_SIDED|95.0|0.33|0.46|||||The estimated value is a point estimate of the Spearman Correlation between the TAPS Tool Cannabis Score and the Oral Fluid Cannabis Screen. A Confidence Interval rather than a dispersion value is therefore reported.|||.46|.33|
71091761|NCT04810962|141690047|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71091762|NCT04810962|141690048|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71152346|NCT03523988|141796860|SUPERIORITY|||||||0.65||||||P-value for pain scores among the three comparison groups with jaw at rest.|ANOVA|||||||0.65
71152347|NCT03523988|141796860|SUPERIORITY|||||||0.82||||||P-value for pain scores among the three comparison groups while lightly biting.|ANOVA|||||||0.82
70969270|NCT03317795|141444325|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.40
70969271|NCT01664559|141444351|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.99
71091763|NCT04810962|141690050|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71091764|NCT04810962|141690051|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71091765|NCT04810962|141690052|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71091766|NCT04810962|141690053|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71091767|NCT04810962|141690054|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71091768|NCT04810962|141690055|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
70969272|NCT01664559|141444352|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||1\) Anticipated pain||||0.31
70969273|NCT01664559|141444352|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2\) pain with injection||||0.33
70969274|NCT01664559|141444352|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||3\) speculum insertion||||0.72
70969275|NCT01664559|141444352|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||4\) tenaculum placement||||0.36
70969276|NCT01664559|141444352|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||5\) uterine sounding||||0.64
70969277|NCT01664559|141444352|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||6\) 5 min after placement||||<0.001
70969278|NCT01664559|141444352|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||7\) 15 min after placement||||<0.001
70969279|NCT01664559|141444353|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||1\) anticipated pain||||0.6
70969280|NCT01664559|141444353|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2\) pain with injection||||1.0
70969281|NCT01664559|141444353|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||3\) speculum insertion||||0.34
70969282|NCT01664559|141444353|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||4\) tenaculum placement||||0.32
70969283|NCT01664559|141444353|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||5\) uterine sounding||||0.04
70969284|NCT01664559|141444353|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||6\) IUD placement||||0.02
71091769|NCT04810962|141690056|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71091770|NCT04810962|141690057|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71091771|NCT04810962|141690058|SUPERIORITY||Mean Difference (Net)|-1.2|||<|0.001|TWO_SIDED|95.0|-1.4|-1.0|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-1.0|-1.4|<0.001
71091772|NCT04810962|141690059|SUPERIORITY||Mean Difference (Net)|-0.5|||<|0.001|TWO_SIDED|95.0|-0.7|-0.3|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.3|-0.7|<0.001
71091773|NCT04810962|141690060|SUPERIORITY||Mean Difference (Net)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.5|-0.3|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.3|-0.5|<0.001
71091774|NCT04810962|141690061|SUPERIORITY||Mean Difference (Net)|-0.05|||<|0.001|TWO_SIDED|95.0|-0.07|-0.02|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.02|-0.07|<0.001
71091775|NCT04810962|141690062|SUPERIORITY||Mean Difference (Net)|-0.08|||<|0.001|TWO_SIDED|95.0|-0.1|-0.05|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.05|-0.10|<0.001
71091776|NCT04810962|141690063|SUPERIORITY||Mean Difference (Net)|-0.08|||<|0.001|TWO_SIDED|95.0|-0.11|-0.05|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.05|-0.11|<0.001
71091777|NCT04810962|141690064|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71152348|NCT03523988|141796860|SUPERIORITY|||||||0.69||||||P-value for pain scores among the three comparison groups while chewing paraffin wax.|ANOVA|||||||0.69
71152349|NCT03523988|141796861|SUPERIORITY|||||||0.53||||||P-value for pain scores among the three comparison groups with jaw at rest.|ANOVA|||||||0.53
71152350|NCT03523988|141796861|SUPERIORITY|||||||0.31||||||P-value for pain scores among the three comparison groups while lightly biting.|ANOVA|||||||0.31
71152351|NCT03523988|141796861|SUPERIORITY|||||||0.37||||||P-value for pain scores among the three comparison groups while chewing paraffin wax.|ANOVA|||||||0.37
70969285|NCT01664559|141444353|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||7\) 5 min after placement||||0.32
70969286|NCT01664559|141444353|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||8\) 15 min after placement||||0.02
70969287|NCT01664559|141444354|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||Reported side effects (nausea, vomiting, dyspepsia, headache, dizziness, drowsiness, injection site itchiness, swelling or pain)||||> 0.05
70969288|NCT01664559|141444354|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Chi-squared|||Injection site pain (just as bad or worse than IUD procedure)||||0.76
70969289|NCT01664559|141444354|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Chi-squared|||Satisfied or very satisfied with IUD placement procedure||||0.76
70969290|NCT01664559|141444354|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Chi-squared|||Would recommend IUD placement to a friend||||0.35
70969291|NCT01664559|141444354|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||Desires additional pain medication||||0.02
70969292|NCT01664559|141444355|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Chi-squared|||Level of training, PGY 1, 2, 3, 4 and Attending||||0.2
70969293|NCT01664559|141444355|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Chi-squared|||IUD type (levonorgestrel or copper)||||0.09
70969294|NCT01664559|141444355|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Purpose of IUD (contraception or heavy menstrual bleeding)||||1.0
70969295|NCT01664559|141444355|SUPERIORITY_OR_OTHER|||||||0.92|TWO_SIDED||||||Chi-squared|||Position of uterus (anteverted, retroverted, midpositioned)||||0.92
70969296|NCT01664559|141444355|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Need for cervical dilation||||1.0
71091778|NCT00460798|141690084|SUPERIORITY_OR_OTHER||Obective Response Rate (Percent)|40.6|||||TWO_SIDED|95.0|35.5|46.0|||||Exact method based on binomial distribution|Objective Response Rate (ORR) = Percentage of participants with best overall response of CR or PR||46.0|35.5|
70969297|NCT01664559|141444355|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared, Corrected|||Able to complete the IUD insertion||||1.0
70969298|NCT01664559|141444355|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||Chi-squared|||Significant bleeding||||0.24
70969299|NCT01664559|141444355|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Major complications||||1.0
70969300|NCT01664559|141444355|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||Took acetaminophen prior to leaving the office||||0.02
70969301|NCT02255409|141444389|OTHER||Mean Difference (Final Values)|1.5|||||TWO_SIDED|95.0|-6.7|9.7||||||Vaccine Group Difference (aQIV - QIV) for A/H1N1 at Day 22||9.7|-6.7|
70969302|NCT02255409|141444389|OTHER||Mean Difference (Final Values)|-6.0|||||TWO_SIDED|95.0|-14.2|2.3||||||Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 22||2.3|-14.2|
70969303|NCT02255409|141444389|OTHER||Mean Difference (Final Values)|16.3|||||TWO_SIDED|95.0|8.4|24.1||||||Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 22||24.1|8.4|
70969304|NCT02255409|141444389|OTHER||Mean Difference (Final Values)|14.2|||||TWO_SIDED|95.0|6.3|22.0||||||Vaccine Group Difference (aQIV - QIV) for B/Victoria at Day 22||22.0|6.3|
70969305|NCT02255409|141444390|OTHER||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.9|2.2||||||Vaccine Group Difference (aQIV - QIV) for A/H1N1 at Day 22||2.2|-0.9|
70969306|NCT02255409|141444390|OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-1.9|1.2||||||Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 22||1.2|-1.9|
70969307|NCT02255409|141444390|OTHER||Mean Difference (Final Values)|14.4|||||TWO_SIDED|95.0|9.3|20.0||||||Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 22||20.0|9.3|
70969308|NCT02255409|141444390|OTHER||Mean Difference (Final Values)|26.0|||||TWO_SIDED|95.0|20.6|32.0||||||Vaccine Group Difference (aQIV - QIV) for B/Victoria at Day 22||32.0|20.6|
70969309|NCT02255409|141444394|OTHER||Mean Difference (Final Values)|5.8|||||TWO_SIDED|95.0|-1.6|13.0||||||Vaccine Group Difference (aQIV - QIV) for A/H1N1 at Day 181||13.0|-1.6|
70969310|NCT02255409|141444394|OTHER||Mean Difference (Final Values)|2.2|||||TWO_SIDED|95.0|-5.5|9.8||||||Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 181||9.8|-5.5|
70969311|NCT02255409|141444394|OTHER||Mean Difference (Final Values)|11.8|||||TWO_SIDED|95.0|5.3|18.3||||||Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 181||18.3|5.3|
70969312|NCT02255409|141444394|OTHER||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-8.4|5.7||||||Vaccine Group Difference (aQIV - QIV) for B/Victoria at Day 181||5.7|-8.4|
70969313|NCT02255409|141444395|OTHER||Mean Difference (Final Values)|4.8|||||TWO_SIDED|95.0|2.4|8.4||||||Vaccine Group Difference (aQIV - QIV) for A/H1N1 at Day 181||8.4|2.4|
70969314|NCT02255409|141444395|OTHER||Mean Difference (Final Values)|5.6|||||TWO_SIDED|95.0|3.1|9.3||||||Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 181||9.3|3.1|
70969315|NCT02255409|141444395|OTHER||Mean Difference (Final Values)|33.2|||||TWO_SIDED|95.0|25.0|40.9||||||Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 181||40.9|25.0|
70969316|NCT02255409|141444395|OTHER||Mean Difference (Final Values)|37.3|||||TWO_SIDED|95.0|29.6|44.7||||||Vaccine Group Difference (aQIV - QIV) for B/Victoria at Day 181||44.7|29.6|
70969317|NCT02255409|141444396|OTHER||GMT Ratio|1.94|||||TWO_SIDED|95.0|1.6|2.4||||||The ratio of GMT (GMTr) values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H1N1 at Day 1.||2.4|1.6|
70969318|NCT02255409|141444396|OTHER||GMT Ratio|1.48|||||TWO_SIDED|95.0|1.3|1.7||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H1N1 at Day 22.||1.7|1.3|
70969319|NCT02255409|141444396|OTHER||GMT Ratio|1.5|||||TWO_SIDED|95.0|1.3|1.7||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H1N1 at Day 181.||1.7|1.3|
70969320|NCT02255409|141444396|OTHER||GMT Ratio|2.16|||||TWO_SIDED|95.0|1.7|2.7||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 1.||2.7|1.7|
70969321|NCT02255409|141444396|OTHER||GMT Ratio|1.34|||||TWO_SIDED|95.0|1.2|1.5||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 22.||1.5|1.2|
70969322|NCT02255409|141444396|OTHER||GMT Ratio|1.34|||||TWO_SIDED|95.0|1.2|1.6||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 181.||1.6|1.2|
70969323|NCT02255409|141444396|OTHER||GMT Ratio|1.82|||||TWO_SIDED|95.0|1.5|2.2||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Yamagata at Day 1.||2.2|1.5|
70969324|NCT02255409|141444396|OTHER||GMT Ratio|1.75|||||TWO_SIDED|95.0|1.5|2.0||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Yamagata at Day 22.||2.0|1.5|
70969325|NCT02255409|141444396|OTHER||GMT Ratio|1.85|||||TWO_SIDED|95.0|1.6|2.2||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Yamagata at Day 181.||2.2|1.6|
70969326|NCT02255409|141444396|OTHER||GMT Ratio|3.24|||||TWO_SIDED|95.0|2.7|4.0||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Victoria at Day 1.||4.0|2.7|
70969327|NCT02255409|141444396|OTHER||GMT Ratio|1.49|||||TWO_SIDED|95.0|1.2|1.8||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Victoria at Day 22.||1.8|1.2|
70969328|NCT02255409|141444396|OTHER||GMT Ratio|1.29|||||TWO_SIDED|95.0|1.1|1.5||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Victoria at Day 181.||1.5|1.1|
70969329|NCT02255409|141444398|OTHER||Mean Difference (Final Values)|5.7|||||TWO_SIDED|95.0|-5.2|16.3||||||Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 181||16.3|-5.2|
70969330|NCT02255409|141444398|OTHER||Mean Difference (Final Values)|14.5|||||TWO_SIDED|95.0|5.3|23.6||||||Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 181||23.6|5.3|
70969331|NCT02255409|141444399|OTHER||Mean Difference (Final Values)|16.3|||||TWO_SIDED|95.0|9.5|24.1||||||Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 181||24.1|9.5|
70969332|NCT02255409|141444399|OTHER||Mean Difference (Final Values)|46.4|||||TWO_SIDED|95.0|35.9|55.8||||||Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 181||55.8|35.9|
70969333|NCT02255409|141444400|OTHER||GMT Ratio|2.63|||||TWO_SIDED|95.0|1.8|3.8||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 1.||3.8|1.8|
70969334|NCT02255409|141444400|OTHER||GMT Ratio|1.57|||||TWO_SIDED|95.0|1.3|2.9||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 22.||2.9|1.3|
70969335|NCT02255409|141444400|OTHER||GMT Ratio|1.7|||||TWO_SIDED|95.0|1.3|2.2||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 181.||2.2|1.3|
71152352|NCT02840461|141796871|EQUIVALENCE|Therapeutic equivalence of the Test product to the Reference product based on the primary endpoint was evaluated in the PP population. If the confidence interval is within 80-125% for the primary endpoint, then the Test and Reference treatments are considered therapeutically equivalent.|Mean Difference (Net)|103.51|||||TWO_SIDED|90.0|97.95|110.0||||||||110.00|97.95|
70969336|NCT02255409|141444400|OTHER||GMT Ratio|1.99|||||TWO_SIDED|95.0|1.5|2.6||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Yamagata at Day 1.||2.6|1.5|
70969337|NCT02255409|141444400|OTHER||GMT Ratio|2.21|||||TWO_SIDED|95.0|1.8|2.7||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 22.||2.7|1.8|
70969338|NCT02255409|141444400|OTHER||GMT Ratio|2.55|||||TWO_SIDED|95.0|2.1|3.2||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 181.||3.2|2.1|
70969339|NCT02189213|141444402|OTHER|The parameters were the CGI-Improvement scale which comprises a one-item measures evaluating the following change from the initiation of treatment on a seven-point scale. The hypothesis is that \~50% of subjects receiving treatment will not respond.|||||=|0.0002|||||||t-test, 2 sided|||At least 50% of subjects will respond to Sertraline treatment (CGI greater than or equal to 2).||||=0.0002
70969340|NCT02424253|141444405|SUPERIORITY||LS Difference|-0.35|||=|0.249|TWO_SIDED|90.0|-1.21|0.51||1-sided p-value.|ANCOVA|The ANCOVA model included baseline value and treatment.||Change from baseline||0.51|-1.21|= 0.249
70969341|NCT02424253|141444406|SUPERIORITY||LS Difference|-5.06|||=|0.01|TWO_SIDED|90.0|-8.66|-1.46||1-sided p-value.|ANCOVA|The ANCOVA model included baseline EASI, stratification variable (worst daily pruritus NRS ≤ 7.5 or \> 7.5) and treatment.||Change from baseline analysis||-1.46|-8.66|= 0.01
70969342|NCT00345176|141444413|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|||<|0.013|TWO_SIDED|98.7|0.76|1.07||Adjusted for 3 treatment versus placebo comparisons and interim analyses|Regression, Cox|Adjusted for baseline AMD status|The reference group is placebo.|Each of the 3 active arms was compared to the placebo/control arm.||1.07|0.76|<0.013
70969343|NCT00345176|141444413|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97|||<|0.013|TWO_SIDED|98.7|0.82|1.16||Adjusted for multiple comparisons|Regression, Cox|||||1.16|0.82|<0.013
70969344|NCT00345176|141444413|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89|||<|0.013|TWO_SIDED|98.7|0.75|1.06|||Regression, Cox|Adjusted for multiple comparisons||||1.06|0.75|<0.013
70969345|NCT00345176|141444414|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95|||<|0.05|TWO_SIDED|95.0|0.84|1.08|||Regression, Cox|||||1.08|0.84|<0.05
70969346|NCT00345176|141444414|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96|||<|0.05|TWO_SIDED|95.0|0.84|1.09|||Regression, Cox|||||1.09|0.84|<0.05
70969347|NCT00345176|141444414|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||<|0.05|TWO_SIDED|95.0|0.83|1.07|||Regression, Cox|||||1.07|0.83|<0.05
70969348|NCT00345176|141444415|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04|||<|0.05|TWO_SIDED|95.0|0.77|1.4|||Regression, Cox|||Comparison of Lutein/Zeaxantin versus Control for mortality||1.40|0.77|<0.05
70969349|NCT00345176|141444415|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13|||<|0.05|TWO_SIDED|95.0|0.84|1.52|||Regression, Cox|||Comparison of DHA/EPA versus Placebo for mortality||1.52|0.84|<0.05
70969350|NCT00345176|141444415|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23|||<|0.05|TWO_SIDED|95.0|0.92|1.65|||Regression, Cox|||Comparison of Lutein/Zeaxanthin + DHA/EPA versus Placebo for Mortality||1.65|0.92|<0.05
70969351|NCT00345176|141444416|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96|||<|0.05|TWO_SIDED|95.0|0.84|1.1|||Regression, Cox|||||1.10|0.84|<0.05
70969352|NCT03998046|141444422|SUPERIORITY|||||||0.85|||||||Chi-squared|||||||.85
70969353|NCT03998046|141444424|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||.20
70969354|NCT03998046|141444425|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||.38
70969355|NCT03998046|141444426|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||.02
70969356|NCT03998046|141444427|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||.01
70969357|NCT03998046|141444428|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||.13
70969358|NCT03998046|141444429|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||||||.61
70969359|NCT03998046|141444430|SUPERIORITY|||||||0.56|||||||Chi-squared|||||||.56
70969360|NCT02290873|141444431|SUPERIORITY||Difference in Rates|0.8961|||<|0.0001|TWO_SIDED|95.0|0.8505|0.9416||P-value calculated from a Cochran-Mantel-Haenszel test accounting for fentanyl strata.|Cochran-Mantel-Haenszel|||||0.9416|0.8505|<0.0001
71152353|NCT02840461|141796871|SUPERIORITY||Mean Difference (Net)|-9.83||||0.0027|TWO_SIDED|95.0|-16.24|-3.42|||ANOVA|||||-3.42|-16.24|0.0027
70969361|NCT02290873|141444432|SUPERIORITY||Hazard Ratio (HR)|6.133|||<|0.0001|TWO_SIDED|95.0|4.416|8.517|||Log Rank|||||8.517|4.416|<0.0001
70969362|NCT01136655|141444435|SUPERIORITY_OR_OTHER||LS mean difference|0.114|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.087|0.142|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.142|0.087|<0.0001
70969363|NCT01136655|141444435|SUPERIORITY_OR_OTHER||LS mean difference|0.105|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.078|0.133|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.133|0.078|<0.0001
70969364|NCT01136655|141444435|SUPERIORITY_OR_OTHER||LS mean difference|0.058|STANDARD_ERROR_OF_MEAN|0.0141||0.0001|TWO_SIDED|95.0|0.03|0.085|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.085|0.030|0.0001
70969365|NCT01136655|141444435|SUPERIORITY_OR_OTHER||LS mean difference|-0.009|STANDARD_ERROR_OF_MEAN|0.0139||0.5223|TWO_SIDED|95.0|-0.036|0.018|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.018|-0.036|0.5223
70969366|NCT01136655|141444435|SUPERIORITY_OR_OTHER||LS mean difference|-0.057|STANDARD_ERROR_OF_MEAN|0.0139||0.0001|TWO_SIDED|95.0|-0.084|-0.029|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.029|-0.084|0.0001
70969367|NCT01136655|141444435|SUPERIORITY_OR_OTHER||LS mean difference|-0.048|STANDARD_ERROR_OF_MEAN|0.0138||0.0007|TWO_SIDED|95.0|-0.075|-0.02|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.020|-0.075|0.0007
70969368|NCT01136655|141444435|SUPERIORITY_OR_OTHER||LS mean difference|-0.114|STANDARD_ERROR_OF_MEAN|0.0141|<|0.0001|TWO_SIDED|95.0|-0.142|-0.086|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.086|-0.142|<0.0001
70969369|NCT01136655|141444435|SUPERIORITY_OR_OTHER||LS mean difference|-0.056|STANDARD_ERROR_OF_MEAN|0.0141||0.0001|TWO_SIDED|95.0|-0.084|-0.028|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.028|-0.084|0.0001
71152354|NCT02840461|141796871|SUPERIORITY||Mean Difference (Net)|-9.83||||0.0028|TWO_SIDED|95.0|-16.25|-3.4|||ANOVA|||||-3.40|-16.25|0.0028
70969370|NCT01136655|141444435|SUPERIORITY_OR_OTHER||LS mean difference|-0.009|STANDARD_ERROR_OF_MEAN|0.0141||0.5394|TWO_SIDED|95.0|-0.036|0.019|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.019|-0.036|0.5394
70969371|NCT01136655|141444435|SUPERIORITY_OR_OTHER||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.014||0.9863|TWO_SIDED|95.0|-0.027|0.028|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.028|-0.027|0.9863
70969372|NCT01136655|141444436|SUPERIORITY_OR_OTHER||LS mean difference|0.105|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.056|0.155|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.155|0.056|<0.0001
70969373|NCT01136655|141444436|SUPERIORITY_OR_OTHER||LS mean difference|0.066|STANDARD_ERROR_OF_MEAN|0.0252||0.0092|TWO_SIDED|95.0|0.017|0.116|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.116|0.017|0.0092
70969374|NCT01136655|141444436|SUPERIORITY_OR_OTHER||LS mean difference|0.015|STANDARD_ERROR_OF_MEAN|0.0252||0.5509|TWO_SIDED|95.0|-0.035|0.065|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.065|-0.035|0.5509
70969375|NCT01136655|141444436|SUPERIORITY_OR_OTHER||LS mean difference|-0.039|STANDARD_ERROR_OF_MEAN|0.0249||0.1163|TWO_SIDED|95.0|-0.088|0.01|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.010|-0.088|0.1163
70969376|NCT01136655|141444436|SUPERIORITY_OR_OTHER||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.025||0.0004|TWO_SIDED|95.0|-0.14|-0.041|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.041|-0.140|0.0004
70969377|NCT01136655|141444436|SUPERIORITY_OR_OTHER||LS mean difference|-0.051|STANDARD_ERROR_OF_MEAN|0.0247||0.04|TWO_SIDED|95.0|-0.1|-0.002|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.002|-0.100|0.0400
70969378|NCT01136655|141444436|SUPERIORITY_OR_OTHER||LS mean difference|-0.083|STANDARD_ERROR_OF_MEAN|0.0252||0.0011|TWO_SIDED|95.0|-0.133|-0.034|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.034|-0.133|0.0011
70969379|NCT01136655|141444436|SUPERIORITY_OR_OTHER||LS mean difference|-0.068|STANDARD_ERROR_OF_MEAN|0.0254||0.0077|TWO_SIDED|95.0|-0.118|-0.018|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.018|-0.118|0.0077
71152355|NCT02840461|141796872|EQUIVALENCE|If the 90% confidence interval (with Yates correction) for the difference between the proportion of patients in the Test and Reference groups considered to be a clinical success was contained within the pre-defined equivalence limits \[-20%, +20%\], the therapeutic equivalence of the Test to Reference product was considered supported.|Mean Difference (Net)|5.8|||||TWO_SIDED|90.0|-2.7|14.2||||||||14.2|-2.7|
70969380|NCT01136655|141444436|SUPERIORITY_OR_OTHER||LS mean difference|-0.017|STANDARD_ERROR_OF_MEAN|0.0252||0.4957|TWO_SIDED|95.0|-0.067|0.033|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.033|-0.067|0.4957
70969381|NCT01136655|141444436|SUPERIORITY_OR_OTHER||LS mean difference|0.022|STANDARD_ERROR_OF_MEAN|0.025||0.38|TWO_SIDED|95.0|-0.027|0.071|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.071|-0.027|0.3800
70969382|NCT01136655|141444437|SUPERIORITY_OR_OTHER||LS mean difference|0.107|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.073|0.14|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.140|0.073|<0.0001
70969383|NCT01136655|141444437|SUPERIORITY_OR_OTHER||LS mean difference|0.112|STANDARD_ERROR_OF_MEAN|0.0171|<|0.0001|TWO_SIDED|95.0|0.078|0.146|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.146|0.078|<0.0001
70969384|NCT01136655|141444437|SUPERIORITY_OR_OTHER||LS mean difference|0.057|STANDARD_ERROR_OF_MEAN|0.0172||0.0011|TWO_SIDED|95.0|0.023|0.09|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.090|0.023|0.0011
70969385|NCT01136655|141444437|SUPERIORITY_OR_OTHER||LS mean difference|0.005|STANDARD_ERROR_OF_MEAN|0.0169||0.7589|TWO_SIDED|95.0|-0.028|0.039|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.039|-0.028|0.7589
70969386|NCT01136655|141444437|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.017||0.0035|TWO_SIDED|95.0|-0.084|-0.017|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.017|-0.084|0.0035
70969387|NCT01136655|141444437|SUPERIORITY_OR_OTHER||LS mean difference|-0.055|STANDARD_ERROR_OF_MEAN|0.0168||0.0011|TWO_SIDED|95.0|-0.089|-0.022|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.022|-0.089|0.0011
70969388|NCT01136655|141444437|SUPERIORITY_OR_OTHER||LS mean difference|-0.115|STANDARD_ERROR_OF_MEAN|0.0171|<|0.0001|TWO_SIDED|95.0|-0.149|-0.081|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.081|-0.149|<0.0001
70969389|NCT01136655|141444437|SUPERIORITY_OR_OTHER||LS mean difference|-0.058|STANDARD_ERROR_OF_MEAN|0.0172||0.0008|TWO_SIDED|95.0|-0.092|-0.024|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.024|-0.092|0.0008
70969390|NCT01136655|141444437|SUPERIORITY_OR_OTHER||LS mean difference|-0.003|STANDARD_ERROR_OF_MEAN|0.0172||0.8582|TWO_SIDED|95.0|-0.037|0.031|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.031|-0.037|0.8582
70969391|NCT01136655|141444437|SUPERIORITY_OR_OTHER||LS mean difference|-0.008|STANDARD_ERROR_OF_MEAN|0.017||0.6276|TWO_SIDED|95.0|-0.042|0.025|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.025|-0.042|0.6276
70969392|NCT01136655|141444438|SUPERIORITY_OR_OTHER||LS mean difference|0.52|||<|0.0001|TWO_SIDED|95.0|0.393|0.7|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) \[log(response + 1) if response is 0\].||Factors in the ANOVA model included: patient, period and treatment.||0.700|0.393|<0.0001
70969393|NCT01136655|141444438|SUPERIORITY_OR_OTHER||LS mean difference|0.26|||<|0.0001|TWO_SIDED|95.0|0.194|0.347|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) \[log(response + 1) if response is 0\].||Factors in the ANOVA model included: patient, period and treatment.||0.347|0.194|<0.0001
70969394|NCT01136655|141444438|SUPERIORITY_OR_OTHER||LS mean difference|0.29|||<|0.0001|TWO_SIDED|95.0|0.214|0.396|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) \[log(response + 1) if response is 0\].||Factors in the ANOVA model included: patient, period and treatment.||0.396|0.214|<0.0001
70969395|NCT01136655|141444438|SUPERIORITY_OR_OTHER||LS mean difference|0.49|||<|0.0001|TWO_SIDED|95.0|0.371|0.659|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) \[log(response + 1) if response is 0\].||Factors in the ANOVA model included: patient, period and treatment.||0.659|0.371|<0.0001
70969396|NCT01136655|141444438|SUPERIORITY_OR_OTHER||LS mean difference|0.56||||0.0002|TWO_SIDED|95.0|0.409|0.755|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) \[log(response + 1) if response is 0\].||Factors in the ANOVA model included: patient, period and treatment.||0.755|0.409|0.0002
70969397|NCT01136655|141444438|SUPERIORITY_OR_OTHER||LS mean difference|1.12||||0.4512|TWO_SIDED|95.0|0.827|1.528|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) \[log(response + 1) if response is 0\].||Factors in the ANOVA model included: patient, period and treatment.||1.528|0.827|0.4512
70969398|NCT02354222|141444450|SUPERIORITY||Least Squares Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-1.16|-0.72|||ANCOVA|||||-0.72|-1.16|<0.001
70969399|NCT02354222|141444451|SUPERIORITY||Least Squares Mean Difference|-15.6|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|95.0|-23.3|-7.9|||ANCOVA|||||-7.9|-23.3|<0.001
70969400|NCT02354222|141444452|SUPERIORITY||Least Squares Mean Difference|1.43|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|0.63|2.23|||ANCOVA|||||2.23|0.63|<0.001
70969401|NCT02354222|141444453|SUPERIORITY||Least Squares Mean Difference|-55.9|STANDARD_ERROR_OF_MEAN|9.2|<|0.001|TWO_SIDED|95.0|-74.1|-37.6|||ANCOVA|||||-37.6|-74.1|<0.001
70969402|NCT02354222|141444454|SUPERIORITY||Least Squares Mean Difference|-37.6|STANDARD_ERROR_OF_MEAN|6.2|<|0.001|TWO_SIDED|95.0|-49.9|-25.2|||ANCOVA|||||-25.2|-49.9|<0.001
71008436|NCT01566981|141524745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6925|STANDARD_DEVIATION|1.4708||0.005|TWO_SIDED|95.0|0.2221|1.1629|||t-test, 2 sided|without adjustments, df=39||"Null hypothesis was that Information and Communication Technology (ICT) supported diabetes care could have significant impact on reduction of baseline glycated hemoglobin (EHbA1c) after 1 year follow-up.~The sample in intervention group was normally distributed, so observed power (two-tailed hypothesis) was 0.45, for Cohen's d= 0.6 and alpha level =0.05"||1.1629|0.2221|0.005
70969403|NCT01342484|141444457|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|0.48||0.3295|TWO_SIDED|95.0|-1.47|0.51|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean Difference (Net Values) is actually the adjusted mean difference calculated as Linagliptin 1 mg minus Placebo.|Superiority of Linagliptin 1 mg vs. placebo: change from baseline in HbA1c using a restricted maximum likelihood (REML) - based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c and age as linear covariates; treatment, gender, pharmacokinetic (PK) / pharmacodynamics (PD) subgroup, background therapy, visit and visit by treatment interaction as fixed effects and patient as a random effect. The unstructured covariance structure has been used to fit the mixed model.||0.51|-1.47|0.3295
70969404|NCT01342484|141444457|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.63|STANDARD_ERROR_OF_MEAN|0.42||0.1447|TWO_SIDED|95.0|-1.5|0.23|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean Difference (Net Values) is actually the adjusted mean difference calculated as Linagliptin 5 mg minus Placebo.|Superiority of Linagliptin 5 mg vs. placebo: change from baseline in HbA1c using a restricted maximum likelihood (REML) - based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c and age as linear covariates; treatment, gender, PK/PD subgroup, background therapy, visit and visit by treatment interaction as fixed effects and patient as a random effect. The unstructured covariance structure has been used to fit the mixed model.||0.23|-1.50|0.1447
70969405|NCT01342484|141444459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|1.36||0.8216|TWO_SIDED|95.0|-3.08|2.46|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean Difference (Net Values) is actually the adjusted mean difference calculated as Linagliptin 1 mg minus Placebo.|Superiority of Linagliptin 1 mg vs. placebo: change from baseline in FPG using a restricted maximum likelihood (REML) - based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c, baseline FPG and age as linear covariates; treatment, gender, PK/PD subgroup, background therapy, visit and visit by treatment interaction as fixed effects and patient as a random effect. The unstructured covariance structure has been used to fit the mixed model.||2.46|-3.08|0.8216
70969406|NCT01342484|141444459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9|STANDARD_ERROR_OF_MEAN|1.18||0.1189|TWO_SIDED|95.0|-4.31|0.52|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean Difference (Net Values) is actually the adjusted mean difference calculated as Linagliptin 5 mg minus Placebo.|Superiority of Linagliptin 5 mg vs. placebo: change from baseline in FPG using a restricted maximum likelihood (REML) - based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c, baseline FPG and age as linear covariates; treatment, gender, PK/PD subgroup, background therapy, visit and visit by treatment interaction as fixed effects and patient as a random effect. The unstructured covariance structure has been used to fit the mixed model.||0.52|-4.31|0.1189
70969407|NCT00432042|141444502|NON_INFERIORITY_OR_EQUIVALENCE|Measles difference|Mean Difference (Final Values)|1.14|||||TWO_SIDED|95.0|-1.62|4.82|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -10%.|||4.82|-1.62|
70969408|NCT00432042|141444502|NON_INFERIORITY_OR_EQUIVALENCE|Mumps difference|Mean Difference (Final Values)|-1.83|||||TWO_SIDED|95.0|-4.21|1.1|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -10%.|||1.10|-4.21|
70969409|NCT00432042|141444502|NON_INFERIORITY_OR_EQUIVALENCE|Rubella difference|Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-3.19|1.35|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -10%.|||1.35|-3.19|
70969410|NCT00432042|141444502|NON_INFERIORITY_OR_EQUIVALENCE|Varicella difference|Mean Difference (Final Values)|2.53|||||TWO_SIDED|95.0|-0.41|6.58|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -10%.|||6.58|-0.41|
70969411|NCT00432042|141444503|NON_INFERIORITY_OR_EQUIVALENCE|Hepatitis B difference|Mean Difference (Final Values)|1.36|||||TWO_SIDED|95.0|-0.29|4.24|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -5%.|||4.24|-0.29|
70969412|NCT00432042|141444503|NON_INFERIORITY_OR_EQUIVALENCE|Haemophilus Influenza type B difference|Mean Difference (Final Values)|2.97|||||TWO_SIDED|95.0|-0.17|6.89|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -5%.|||6.89|-0.17|
70969413|NCT00432042|141444504|NON_INFERIORITY_OR_EQUIVALENCE|Anti-PT difference|GMT ratio|0.97|||||TWO_SIDED|95.0|0.88|1.08|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -5%.|||1.08|0.88|
71091779|NCT00142415|141690101|OTHER|The maximum tolerated dose (MTD) was determined using a standard 3 + 3 dose-escalation design. The occurrence of DLTs was compared across cohorts.|Maximum tolerated dose (mCi/m^2)|65.0|||||TWO_SIDED|||||||||||||
71091780|NCT03620162|141690118|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-3.4|||=|0.525|TWO_SIDED|95.0|-13.6|7.0|||Miettinen & Nurminen method|||Difference in Percentage: Erythema(Group 5 vs 1)||7.0|-13.6|= 0.525
70969414|NCT00432042|141444504|NON_INFERIORITY_OR_EQUIVALENCE|Anti-FHA difference|GMT ratio|1.09|||||TWO_SIDED|95.0|0.98|1.23|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -5%.|||1.23|0.98|
70969415|NCT00432042|141444504|NON_INFERIORITY_OR_EQUIVALENCE|Anti-PRN difference|GMT ratio|1.18|||||TWO_SIDED|95.0|1.03|1.36|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -5%.|||1.36|1.03|
70969416|NCT02822885|141444505|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
70969417|NCT02822885|141444506|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
71102637|NCT00330733|141713888|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||t-test, 2 sided|||Paired comparisons (follow-up vs baseline) and unpaired group comparisons were performed by Student's t tests or Wilcoxon signed rank tests.||||<0.05
71091781|NCT03620162|141690118|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-4.5|||=|0.396|TWO_SIDED|95.0|-14.7|5.8|||Miettinen & Nurminen method|||Difference in Percentage: Erythema(Group 4 vs 1)||5.8|-14.7|= 0.396
70969418|NCT02822885|141444507|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
70969419|NCT02822885|141444508|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
70969420|NCT02822885|141444509|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
70969421|NCT01733628|141444510|OTHER|Type of statistical Test: Inequality|Hazard Ratio (HR)|0.94||||0.8166|TWO_SIDED|95.0|0.56|1.59|||Wilcoxon (Mann-Whitney)|||||1.59|0.56|0.8166
70969422|NCT00980200|141444517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|||<|0.001|TWO_SIDED|95.0|0.049|0.14|||ANCOVA|||||0.140|0.049|<0.001
70969423|NCT00980200|141444517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||<|0.001|TWO_SIDED|95.0|0.095|0.185|||ANCOVA|||||0.185|0.095|<0.001
70969424|NCT00980200|141444517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|||<|0.001|TWO_SIDED|95.0|0.057|0.147|||ANCOVA|||||0.147|0.057|<0.001
70969425|NCT00980200|141444517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|||<|0.001|TWO_SIDED|95.0|0.08|0.17|||ANCOVA|||||0.170|0.080|<0.001
70969426|NCT00457015|141444519|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0||||No adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|Blocked Wilcoxon rank sum test|||The primary efficacy analysis compared the change from baseline in MSCS Score at 4 hours post-dosing for patients treated with ecallantide and placebo. Treatment effect was assessed by the nonparametric Blocked Wilcoxon Rank Sum test because of an assumed non-normal distribution.||||0.010
70969427|NCT00457015|141444520|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||No adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|Blocked Wilcoxon rank sum test|||The analysis compared the TOS at 4 hours post-dosing for patients treated with ecallantide and placebo. Treatment effect was assessed by the nonparametric Blocked Wilcoxon Rank Sum test because of an assumed non-normal distribution.||||0.003
70969428|NCT00457015|141444521|SUPERIORITY_OR_OTHER_LEGACY|||||||0.102||95.0||||No adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|Log Rank|||Kaplan-Meier analysis using the Log-Rank test was used to compare the time distribution between the 2 treatment groups.||||0.102
70969429|NCT00916357|141444534|SUPERIORITY_OR_OTHER|||||||0.0034||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||60 minutes after study drug injection.||||0.0034
70969430|NCT00916357|141444534|SUPERIORITY_OR_OTHER|||||||0.26||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||60 minutes after study drug injection.||||0.2600
71091782|NCT03620162|141690118|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-8.7|||=|0.097|TWO_SIDED|95.0|-18.8|1.6|||Miettinen & Nurminen method|||Difference in Percentage: Erythema(Group 3 vs 1)||1.6|-18.8|= 0.097
71091783|NCT03620162|141690118|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-9.9|||=|0.057|TWO_SIDED|95.0|-19.9|0.3|||Miettinen & Nurminen method|||Difference in Percentage: Erythema(Group 2 vs 1)||0.3|-19.9|= 0.057
70969431|NCT00916357|141444534|SUPERIORITY_OR_OTHER|||||||0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated measures Analysis of Variance|||60 minutes after study drug injection.||||0.0001
70969432|NCT00916357|141444534|SUPERIORITY_OR_OTHER|||||||0.0039||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||90 minutes after study drug injection.||||0.0039
70969433|NCT00916357|141444534|SUPERIORITY_OR_OTHER|||||||0.93||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||90 minutes after study drug injection.||||0.9300
70969434|NCT00916357|141444534|SUPERIORITY_OR_OTHER|||||||0.0031||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||90 minutes after study drug injection.||||0.0031
70969435|NCT00916357|141444534|SUPERIORITY_OR_OTHER|||||||0.019||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||120 minutes after study drug injection.||||0.0190
70969436|NCT00916357|141444534|SUPERIORITY_OR_OTHER|||||||0.92||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||120 minutes after study drug injection.||||0.9200
70969437|NCT00916357|141444534|SUPERIORITY_OR_OTHER|||||||0.015||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||120 minutes after study drug injection.||||0.0150
70969438|NCT00916357|141444534|SUPERIORITY_OR_OTHER|||||||0.095||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Peak postprandial glucose (PPG) values.||||0.0950
70969439|NCT00916357|141444534|SUPERIORITY_OR_OTHER|||||||0.6||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Peak postprandial glucose (PPG) values.||||0.6000
70969440|NCT00916357|141444534|SUPERIORITY_OR_OTHER|||||||0.031||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Peak postprandial glucose (PPG) values.||||0.0310
70969441|NCT00916357|141444535|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||<0.0001
70969442|NCT00916357|141444535|SUPERIORITY_OR_OTHER|||||||0.18||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.1800
70969443|NCT00916357|141444535|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||<0.0001
70969444|NCT00916357|141444536|SUPERIORITY_OR_OTHER|||||||0.0045||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.0045
70969445|NCT00916357|141444536|SUPERIORITY_OR_OTHER|||||||0.48||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.4800
70969446|NCT00916357|141444536|SUPERIORITY_OR_OTHER|||||||0.0006||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||0.0006
70969447|NCT00916357|141444537|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||<0.0001
70969448|NCT00916357|141444537|SUPERIORITY_OR_OTHER|||||||0.0016||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.0016
70969449|NCT00916357|141444537|SUPERIORITY_OR_OTHER|||||||0.1||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||0.1000
70969450|NCT00916357|141444538|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog alone + Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||<0.0001
70969451|NCT00916357|141444538|SUPERIORITY_OR_OTHER|||||||0.3||||||Treatment comparison for Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.3000
70969452|NCT00916357|141444538|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||<0.0001
70969453|NCT00916357|141444539|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||<0.0001
71091784|NCT03620162|141690118|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-8.4|||=|0.085|TWO_SIDED|95.0|-17.8|1.2|||Miettinen & Nurminen method|||Difference in Percentage: Induration(Group 5 vs 1)||1.2|-17.8|= 0.085
70969454|NCT00916357|141444539|SUPERIORITY_OR_OTHER|||||||0.77||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.7700
70969455|NCT00916357|141444539|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||<0.0001
70969456|NCT00916357|141444540|SUPERIORITY_OR_OTHER|||||||0.01||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.0100
70969457|NCT00916357|141444540|SUPERIORITY_OR_OTHER|||||||0.82||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.8200
70969458|NCT00916357|141444540|SUPERIORITY_OR_OTHER|||||||0.0056||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||0.0056
70969459|NCT00916357|141444541|SUPERIORITY_OR_OTHER|||||||0.064||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \>160 milligrams per deciliter (mg/dL)||||0.064
70969460|NCT00916357|141444541|SUPERIORITY_OR_OTHER|||||||0.47||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \>160 milligrams per deciliter (mg/dL)||||0.47
70969461|NCT00916357|141444541|SUPERIORITY_OR_OTHER|||||||0.012||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \>160 milligrams per deciliter (mg/dL)||||0.012
70969462|NCT00916357|141444541|SUPERIORITY_OR_OTHER|||||||0.099||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \>140 milligrams per deciliter (mg/dL)||||0.099
70969463|NCT00916357|141444541|SUPERIORITY_OR_OTHER|||||||0.46||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \>140 milligrams per deciliter (mg/dL)||||0.46
70969464|NCT00916357|141444541|SUPERIORITY_OR_OTHER|||||||0.02||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \>140 milligrams per deciliter (mg/dL)||||0.020
70969465|NCT00916357|141444541|SUPERIORITY_OR_OTHER|||||||0.13||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \<70 milligrams per deciliter (mg/dL)||||0.13
70969466|NCT00916357|141444541|SUPERIORITY_OR_OTHER|||||||0.41||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \<70 milligrams per deciliter (mg/dL)||||0.41
70969467|NCT00916357|141444541|SUPERIORITY_OR_OTHER|||||||0.46||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \<70 milligrams per deciliter (mg/dL)||||0.46
70969468|NCT00916357|141444542|SUPERIORITY_OR_OTHER|||||||0.016||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.016
70969469|NCT00916357|141444542|SUPERIORITY_OR_OTHER|||||||0.88||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.8800
70969470|NCT00916357|141444542|SUPERIORITY_OR_OTHER|||||||0.011||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||0.011
70969471|NCT00916357|141444544|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Analysis for 10% of exposure (area under the curve \[AUC\])||||<0.0001
70969472|NCT00916357|141444544|SUPERIORITY_OR_OTHER|||||||0.18||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Analysis for 10% of exposure (area under the curve \[AUC\])||||0.1800
70969473|NCT00916357|141444544|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Analysis for 10% of exposure (area under the curve \[AUC\])||||<0.0001
70969474|NCT00916357|141444544|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison for Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Analysis for 50% of exposure (area under the curve \[AUC\])||||<0.0001
71091785|NCT03620162|141690118|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-9.5|||=|0.05|TWO_SIDED|95.0|-18.9|0.0|||Miettinen & Nurminen method|||Difference in Percentage: Induration(Group 4 vs 1)||-0.0|-18.9|= 0.050
70969475|NCT00916357|141444544|SUPERIORITY_OR_OTHER|||||||0.72||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Analysis for 50% of exposure (area under the curve \[AUC\])||||0.7200
70969476|NCT00916357|141444544|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Analysis for 50% of exposure (area under the curve \[AUC\])||||<0.0001
70969477|NCT02257372|141444557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|||<|0.001|TWO_SIDED|95.0|0.071|0.174|||Mixed model repeated measures analysis|||||0.174|0.071|<0.001
70969478|NCT02257372|141444558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|||<|0.001|TWO_SIDED|95.0|0.099|0.197|||Mixed model repeated measures analysis|||||0.197|0.099|<0.001
70969479|NCT01438489|141444608|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38||||0.014|TWO_SIDED|90.0|1.33|4.26|||Regression, Logistic|||All-comers||4.26|1.33|0.014
70969480|NCT01438489|141444608|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.94||||0.063|TWO_SIDED|90.0|1.08|3.49|||Regression, Logistic|||All-comers||3.49|1.08|0.063
70969481|NCT01438489|141444609|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.55||||0.004|TWO_SIDED|90.0|1.72|7.32|||Regression, Logistic|||High||7.32|1.72|0.004
70969482|NCT01438489|141444609|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.65||||0.029|TWO_SIDED|90.0|1.27|5.53|||Regression, Logistic|||High||5.53|1.27|0.029
70969483|NCT00960661|141444661|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was concluded if the upper limit of the 95% confidence interval (CI) for the treatment contrast (BET minus BBT) at week 30 was less than the non inferiority margin.|Mean Difference (Final Values)|-0.04||||0.6273|TWO_SIDED|95.0|-0.18|0.11||The primary mixed-model repeated measures (MMRM) model included baseline HbA1c as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.|Mixed model repeated measures|||The primary objective is to test the hypothesis that BET is non inferior to BBT with respect to change in HbA1c from baseline to Week 30.||0.11|-0.18|0.6273
70969484|NCT01324232|141444685|SUPERIORITY||Pearson correlation|0.0019|||=|0.9827|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis that the true correlation between the change from Baseline PRS scores and the DM plasma concentration was equal to zero and was tested using a 2-sided test at the 5% level of significance within active treatment groups. The regression line was fitted using change from baseline in average PRS during Day 57-84 as the dependent variable and the average of log-transformed DM Plasma Concentration at Day 22 and Day 50 as the independent variable.||||= 0.9827
70969485|NCT01324232|141444687|SUPERIORITY||||||=|0.8869|||||||ANCOVA|||Test of dose trend (overall P value)||||=0.8869
71091786|NCT03620162|141690118|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-6.5|||=|0.183|TWO_SIDED|95.0|-16.1|3.1|||Miettinen & Nurminen method|||Difference in Percentage: Induration(Group 3 vs 1)||3.1|-16.1|= 0.183
71091787|NCT03620162|141690118|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-8.7|||=|0.074|TWO_SIDED|95.0|-18.1|0.8|||Miettinen & Nurminen method|||Difference in Percentage: Induration(Group 2 vs 1)||0.8|-18.1|= 0.074
70969486|NCT01324232|141444687|SUPERIORITY||Adjusted mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.46|=|0.9381|TWO_SIDED|95.0|-0.94|0.87|||ANCOVA|||Pairwise treatment group vs placebo||0.87|-0.94|=0.9381
70969487|NCT01324232|141444687|SUPERIORITY||Adjusted mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.46|=|0.4128|TWO_SIDED|95.0|-1.28|0.53|||ANCOVA|||Pairwise treatment group vs placebo||0.53|-1.28|=0.4128
70969488|NCT01324232|141444687|SUPERIORITY||Adjusted mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.461|=|0.9427|TWO_SIDED|95.0|-0.88|0.94|||ANCOVA|||Pairwise treatment group vs placebo||0.94|-0.88|=0.9427
70969489|NCT01324232|141444687|SUPERIORITY||Adjusted mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.401|=|0.6075|TWO_SIDED|95.0|-1.0|0.58|||ANCOVA|||Pairwise treatment group vs placebo||0.58|-1.0|=0.6075
70969490|NCT01324232|141444687|SUPERIORITY||Adjusted mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.402|=|0.669|TWO_SIDED|95.0|-0.96|0.62|||ANCOVA|||Pairwise treatment group vs placebo||0.62|-0.96|=0.6690
70969491|NCT01324232|141444687|SUPERIORITY||Adjusted mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.38|=|0.7394|TWO_SIDED|95.0|-0.88|0.62|||ANCOVA|||Pairwise treatment group vs placebo||0.62|-0.88|=0.7394
70969492|NCT01324232|141444688|SUPERIORITY||||||=|0.9731|TWO_SIDED|||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.|ANCOVA|||||||=0.9731
70969493|NCT01324232|141444688|SUPERIORITY||Mean difference (final values)|1.32|STANDARD_ERROR_OF_MEAN|2.42|||TWO_SIDED|95.0|-3.46|6.09||||||||6.09|-3.46|
70969494|NCT01324232|141444688|SUPERIORITY||Mean difference (final values)|-3.0|STANDARD_ERROR_OF_MEAN|2.394|||TWO_SIDED|95.0|-7.72|1.72||||||||1.72|-7.72|
70969495|NCT01324232|141444688|SUPERIORITY||Mean difference (final values)|1.2|STANDARD_ERROR_OF_MEAN|2.408|||TWO_SIDED|95.0|-3.54|5.95||||||||5.95|-3.54|
70969496|NCT01324232|141444690|SUPERIORITY||||||=|0.4778||||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.|ANCOVA|||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.||||=0.4778
70969497|NCT01324232|141444690|SUPERIORITY||Adjusted mean difference|0.49|STANDARD_ERROR_OF_MEAN|3.676|||TWO_SIDED|95.0|-6.76|7.74||||||||7.74|-6.76|
70969498|NCT01324232|141444690|SUPERIORITY||Adjusted mean difference|-1.67|STANDARD_ERROR_OF_MEAN|3.663|||TWO_SIDED|95.0|-8.89|5.56||||||||5.56|-8.89|
70969499|NCT01324232|141444690|SUPERIORITY||Adjusted mean difference|3.43|STANDARD_ERROR_OF_MEAN|3.681|||TWO_SIDED|95.0|-3.83|10.68||||||||10.68|-3.83|
70969500|NCT01324232|141444691|SUPERIORITY||||||=|0.0685|TWO_SIDED|||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.|ANCOVA|||||||=0.0685
70969501|NCT01324232|141444691|SUPERIORITY||Mean difference (final values)|-0.51|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|95.0|-1.85|0.83||||||||0.83|-1.85|
70969502|NCT01324232|141444691|SUPERIORITY||Mean difference (final values)|-0.85|STANDARD_ERROR_OF_MEAN|0.677|||TWO_SIDED|95.0|-2.19|0.48||||||||0.48|-2.19|
70969503|NCT01324232|141444691|SUPERIORITY||Mean difference (final values)|-1.2|STANDARD_ERROR_OF_MEAN|0.681|||TWO_SIDED|95.0|-2.54|0.15||||||||0.15|-2.54|
70969504|NCT01324232|141444692|SUPERIORITY||||||=|0.4201|TWO_SIDED|||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.|ANCOVA|||||||=0.4201
71091788|NCT03620162|141690118|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|3.4|||=|0.525|TWO_SIDED|95.0|-7.0|13.6|||Miettinen & Nurminen method|||Difference in Percentage: Tenderness(Group 5 vs 1)||13.6|-7.0|= 0.525
70969505|NCT01324232|141444692|SUPERIORITY||Adjusted mean difference|-0.49|STANDARD_ERROR_OF_MEAN|1.473|||TWO_SIDED|95.0|-3.4|2.41||||||||2.41|-3.40|
70969506|NCT01324232|141444692|SUPERIORITY||Adjusted mean difference|-0.9|STANDARD_ERROR_OF_MEAN|1.454|||TWO_SIDED|95.0|-3.76|1.97||||||||1.97|-3.76|
70969507|NCT01324232|141444692|SUPERIORITY||Adjusted mean difference|1.46|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|95.0|-1.42|4.34||||||||4.34|-1.42|
70969508|NCT01324232|141444693|SUPERIORITY||||||=|0.8068||||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.|ANCOVA|||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.||||=0.8068
70969509|NCT01324232|141444693|SUPERIORITY||Adjusted mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.205|||TWO_SIDED|95.0|-3.47|1.28||||||||1.28|-3.47|
70969510|NCT01324232|141444693|SUPERIORITY||Adjusted mean difference|-0.63|STANDARD_ERROR_OF_MEAN|1.2|||TWO_SIDED|95.0|-2.99|1.74||||||||1.74|-2.99|
70969511|NCT01324232|141444693|SUPERIORITY||Adjusted mean difference|0.31|STANDARD_ERROR_OF_MEAN|1.207|||TWO_SIDED|95.0|-2.07|2.69||||||||2.69|-2.07|
70969512|NCT01324232|141444694|SUPERIORITY||||||=|0.6315||||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect. Oral responses.|ANCOVA|||||||=0.6315
70969513|NCT01324232|141444694|SUPERIORITY||Adjusted mean difference|2.37|STANDARD_ERROR_OF_MEAN|2.772|||TWO_SIDED|95.0|-3.19|7.93||||||||7.93|-3.19|
70969514|NCT01324232|141444694|SUPERIORITY||Adjusted mean difference|1.31|STANDARD_ERROR_OF_MEAN|2.562|||TWO_SIDED|95.0|-3.83|6.45||||||||6.45|-3.83|
70969515|NCT01324232|141444694|SUPERIORITY||Adjusted mean difference|1.46|STANDARD_ERROR_OF_MEAN|2.728|||TWO_SIDED|95.0|-4.01|6.94||||||||6.94|-4.01|
70969516|NCT01324232|141444694|SUPERIORITY||||||=|0.1485|TWO_SIDED|||||P-value presented tests the hypothesis for overall treatment effect versus no treatment effect. Written responses.|ANCOVA|||||||=0.1485
70969517|NCT01324232|141444694|SUPERIORITY||Mean difference (final values)|1.77|STANDARD_ERROR_OF_MEAN|1.558|||TWO_SIDED|95.0|-1.31|4.85||||||||4.85|-1.31|
70969518|NCT01324232|141444694|SUPERIORITY||Mean difference (final values)|-1.68|STANDARD_ERROR_OF_MEAN|1.605|||TWO_SIDED|95.0|-4.86|1.49||||||||1.49|-4.86|
70969519|NCT01324232|141444694|SUPERIORITY||Mean difference (final values)|-1.65|STANDARD_ERROR_OF_MEAN|1.549|||TWO_SIDED|95.0|-4.71|1.41||||||||1.41|-4.71|
70969520|NCT01324232|141444695|SUPERIORITY||||||=|0.1404|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis is that the true correlation between NRS scores and DM plasma concentration is equal to zero. Only 158 of the 209 participants in the mITT Population were analyzed at Day 22.||||=0.1404
70969521|NCT01324232|141444695|SUPERIORITY||||||=|0.0805|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis that the true correlation between NRS scores and DM plasma concentration is equal to zero. Only 152 of the 209 participants in the mITT Population were analyzed at Day 50.||||=0.0805
70969522|NCT01324232|141444695|SUPERIORITY||||||=|0.0551|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis that the true correlation between NRS scores and DM plasma concentration is equal to zero. Only 185 of the 209 participants in the mITT Population were analyzed at Day 85.||||=0.0551
70969523|NCT01324232|141444696|SUPERIORITY||||||=|0.9207|TWO_SIDED|||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.|ANCOVA|||||||=0.9207
70969524|NCT02184195|141444705|SUPERIORITY||Hazard Ratio (HR)|0.531||||0.0038|TWO_SIDED|95.0|0.346|0.815|||Log-rank test|||||0.815|0.346|0.0038
70969525|NCT02184195|141444706|OTHER||Hazard Ratio (HR)|0.831||||0.3487|TWO_SIDED|95.0|0.564|1.224|||Log-rank test|||||1.224|0.564|0.3487
70969526|NCT02184195|141444707|SUPERIORITY||Hazard Ratio (HR)|0.659||||0.0613|TWO_SIDED|95.0|0.426|1.02|||Log-rank test|||||1.020|0.426|0.0613
70969527|NCT02184195|141444708|SUPERIORITY||Hazard Ratio (HR)|0.611||||0.0111|TWO_SIDED|95.0|0.418|0.894|||Log-rank test|||||0.894|0.418|0.0111
70969528|NCT02184195|141444709|SUPERIORITY||Hazard Ratio (HR)|0.442|||<|0.0001|TWO_SIDED|95.0|0.297|0.658|||Log-rank test|||||0.658|0.297|<0.0001
70969529|NCT02184195|141444710|SUPERIORITY||Hazard Ratio (HR)|0.425|||<|0.0001|TWO_SIDED|95.0|0.289|0.627|||Log-rank test|||||0.627|0.289|<0.0001
70969530|NCT02184195|141444711|SUPERIORITY||Odds Ratio (OR)|1.52||||0.3273|TWO_SIDED|95.0|0.668|3.61|||Regression, Logistic|||||3.610|0.668|0.3273
70969531|NCT02184195|141444713|SUPERIORITY||Mean Difference (Final Values)|-2.21||||0.355|TWO_SIDED|95.0|-6.917|2.496|||Mixed Models Analysis|||||2.496|-6.917|0.355
70969532|NCT02370615|141444738|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 10/Day 1)|2.012|||||TWO_SIDED|90.0|1.632|2.481||||||Analysis for TAK 272F||2.481|1.632|
70969533|NCT02370615|141444738|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 10/Day 1)|0.089|||||TWO_SIDED|90.0|0.064|0.123||||||Analysis for TAK 272-M-I||0.123|0.064|
70969534|NCT02370615|141444739|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 10/Day 1)|4.888|||||TWO_SIDED|90.0|4.137|5.777||||||Analysis for TAK 272F||5.777|4.137|
70969535|NCT02370615|141444740|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 10/Day 1)|4.702|||||TWO_SIDED|90.0|3.969|5.569||||||Analysis for TAK 272F||5.569|3.969|
70969536|NCT02370615|141444740|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 10/Day 1)|0.023|||||TWO_SIDED|90.0|0.012|0.045||||||Analysis for TAK 272-M-I||0.045|0.012|
70969537|NCT02370615|141444742|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.349|||||TWO_SIDED|90.0|1.117|1.628||||||||1.628|1.117|
70969538|NCT02370615|141444743|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.02|||||TWO_SIDED|90.0|0.919|1.131||||||||1.131|0.919|
70969539|NCT02370615|141444744|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.155|||||TWO_SIDED|90.0|1.035|1.289||||||||1.289|1.035|
70969540|NCT02370615|141444746|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.235|||||TWO_SIDED|90.0|1.1|1.387||||||Analysis for Midazolam||1.387|1.100|
70969541|NCT02370615|141444746|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|0.887|||||TWO_SIDED|90.0|0.781|1.008||||||Analysis for 1'Hydroxymidazolam||1.008|0.781|
70969542|NCT02370615|141444747|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.422|||||TWO_SIDED|90.0|1.29|1.568||||||Analysis for Midazolam||1.568|1.290|
70969543|NCT02370615|141444747|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.081|||||TWO_SIDED|90.0|1.008|1.16||||||Analysis for 1'Hydroxymidazolam||1.160|1.008|
70969544|NCT02370615|141444748|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.425|||||TWO_SIDED|90.0|1.291|1.574||||||Analysis for Midazolam||1.574|1.291|
70969545|NCT02370615|141444748|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.061|||||TWO_SIDED|90.0|0.986|1.143||||||Analysis for 1'Hydroxymidazolam||1.143|0.986|
70969546|NCT01970501|141444771|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.905|TWO_SIDED|95.0|0.72|1.45|||Log Rank|||||1.45|.72|0.905
70969547|NCT01970501|141444772|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.961|TWO_SIDED|95.0|0.71|1.42|||Log Rank|||||1.42|0.71|0.961
70969548|NCT03924752|141444775|OTHER|A two-way repeated-measures analysis of variance (ANOVA) was performed on different walking conditions (including the baseline of not wearing the exoskeleton) on the subject's overground self-selected walking speed across different locomotion modes by setting the significant value to 0.05. Two independent variables were assistance type (Exo vs No Exo) and different locomotion modes.||||||0.9547||||||This presents the effect of exoskeleton assistance on the user's preferred overground walking speed across different locomotion modes.|ANOVA|||||||0.9547
70969549|NCT03803059|141444776|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Calculated using Wilcoxon signed rank test. Testing hypothesis is that the mean change from baseline is zero||||<0.01
70969550|NCT03803059|141444777|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Calculated using Wilcoxon signed rank test. Testing hypothesis is that the mean score is equal to 4 (no change).||||<0.01
70969551|NCT03803059|141444778|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Calculated using the Wilcoxon signed rank test. Testing hypothesis is that the mean score is equal to 4.||||<0.01
70969552|NCT03803059|141444779|SUPERIORITY|||||||0.051|||||||t-test, 1 sided|||Calculated using paired t-test. The testing hypothesis is that the mean change from baseline is zero.||||0.051
70969553|NCT03803059|141444780|SUPERIORITY||||||<|0.01|||||||t-test, 1 sided|||Calculated from paired t-test. The testing hypothesis is that the mean change from baseline is zero.||||<0.01
70969554|NCT03803059|141444781|SUPERIORITY|||||||0.331|||||||t-test, 1 sided|||Calculated from paired t-test. The testing hypothesis is that the mean change from baseline is zero.||||0.331
70969555|NCT03803059|141444782|SUPERIORITY|||||||0.863|||||||t-test, 2 sided|||Calculated using the paired t test. Testing hypothesis is that the mean change from baseline is zero.||||0.863
70969556|NCT03803059|141444783|SUPERIORITY|||||||0.048|||||||t-test, 2 sided|||Calculated using the paired t-test. The testing hypothesis is that the mean change from baseline is zero.||||0.048
70969557|NCT03803059|141444784|SUPERIORITY|||||||0.355||||||P-value reported is for viscoelastic deformation.|t-test, 2 sided|at significance level alpha+0.05||Calculated using the paired t-test. The testing hypothesis is that the mean change from baseline is zero.||||0.355
70969558|NCT03803059|141444785|SUPERIORITY|||||||0.859||||||Calculated with a paired T test. Testing hypothesis is that the mean change from baseline is zero.|t-test, 2 sided|||Calculated using the paired t test. Testing hypothesis is that the mean change from baseline is zero.||||0.859
70969559|NCT03803059|141444786|EQUIVALENCE|.A binomial (sign) test was performed to test if the the proportion of the combined designated favorable evaluations/responses is equal to the combined designated negative evaluations/responses for each question|||||<|0.01|||||||Sign test|||Patient satisfaction questionnaires were tabulated, and the frequency and percentage of all response options were reported for each question and time point calculated from the binomial (sign) test. The testing hypothesis is that the proportion of favorable responses is equal to the unfavorable||||<0.01
70969560|NCT03803059|141444787|SUPERIORITY|||||||0.031||||||All statistical tests were 2-sided at significance level alpha=0.05. No multiple testing corrections were considered in the study.|t-test, 2 sided|||The null hypothesis that the mean change from baseline is zero was tested using a paired t-test||||0.031
70969561|NCT04013529|141444790|SUPERIORITY||||||=|0.9|||||||ANCOVA|||||||=0.90
70969562|NCT04013529|141444791|SUPERIORITY||||||=|0.88|||||||ANCOVA|||||||= 0.88
70969563|NCT04013529|141444792|SUPERIORITY||||||<|0.17|||||||ANCOVA|||||||< 0.17
70969564|NCT04013529|141444793|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||< 0.05
70969565|NCT04013529|141444794|SUPERIORITY||||||=|0.81|||||||ANCOVA|||||||= 0.81
70969566|NCT02116777|141444812|OTHER|Maximum Tolerate Dose Level was determined by the rolling-6 design.|Maximum Tolerate Dose Level|4.0|||||TWO_SIDED||||||||Maximum Tolerate Dose Level is Dose Level 4 (600 mcg/m²/dose +30 mg/m2/dose (BMN 673) BID + 30 mg/m²/dose (TEM), Max 1000 mcg/day). MTD determined by using the Rolling-6 Design.|||||
70969567|NCT00102960|141444833|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.59||||0.02|TWO_SIDED|95.0|0.38|0.93|||Regression, Cox|||Statistical analysis compares early therapy 40 weeks (ART-40W) relative to deferred therapy (ART-Def)||0.93|0.38|0.02
70969568|NCT00102960|141444833|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.47||||0.002|TWO_SIDED|95.0|0.27|0.76|||Regression, Cox|||Statistical analysis compares early therapy 96 weeks (ART-96W) relative to deferred therapy (ART-Def)||0.76|0.27|0.002
70969569|NCT00102960|141444838|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Cummulative Probability|0.13||||0.03|TWO_SIDED|95.0|0.01|0.25|||Proportion test|||Relative to ART-Def, ART-40W had a 13% difference in the cumulative probability of clinical disease progression or death at 3·5 years||0.25|0.01|0.03
70969570|NCT00102960|141444838|SUPERIORITY||Kaplan-Meier Cummulative Probability|0.2||||0.0006|TWO_SIDED|95.0|0.09|0.31|||Proportion test|||Relative to ART-Def, ART-96W had a 13% difference in the cumulative probability of clinical disease progression or death at 3·5 years||0.31|0.09|0.0006
70969571|NCT00102960|141444839|SUPERIORITY_OR_OTHER_LEGACY||Rate per 100 person years|0.0|||<|0.0001|TWO_SIDED|||||This p-value compares event rates per 100 person-years across the three arms|Poisson Regression|||The CHER study compared Grade 3 or 4 clinical event rates per 100 person-years between the three arms using Poisson regression modeling over the study duration of 4.8 years.|The rates per 100 person-years were 33.8 (Arm 1), 21.6 (Arm 2) and 16 (Arm 3)|||<0.0001
70969572|NCT00102960|141444840|SUPERIORITY||Rate per 100 person years|0.0||||0.46|TWO_SIDED||||||Poisson regression|||The event rates per 100 person years were compared across the three arms|The laboratory events per 100 person years across the three arms were: 7 (Deferred arm), 8.1 (early therapy for 40 weeks) and 6 (early therapy for 96 weeks).|||0.46
70969573|NCT00102960|141444843|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.48||||0.011|TWO_SIDED|95.0|0.27|0.84|||Regression, Cox||Hazard rate reported above compares early therapy 40 weeks relative to the deferred therapy arm.|The analysis compares ART-40W relative to the ART-Def arm.||0.84|0.27|0.011
70969574|NCT00102960|141444843|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.34||||0.0009|TWO_SIDED|95.0|0.18|0.64|||Regression, Cox||The hazard ratio compares ART-96W relative to the ART-Def arm.|The analysis compares ART-96 Weeks relative to ART-Deferred||0.64|0.18|0.0009
70969575|NCT00102960|141444845|SUPERIORITY||Count of days|0.0||||0.004|TWO_SIDED|||||The p-value here compares the days spent in hospital across the three arms|Poisson regression||||The total number of days/count of days: 1018 (Arm 1), 533 (Arm 2) and 414 (Arm 3) were compared across the three groups by Poisson regression analysis.|||0.004
70969576|NCT00102960|141444846|SUPERIORITY||Hazard Ratio (HR)|0.562||||0.0021|TWO_SIDED|95.0|0.389|0.811|||Regression, Cox|||||0.811|0.389|0.0021
70969577|NCT00102960|141444846|SUPERIORITY||Hazard Ratio (HR)|0.583||||0.0038|TWO_SIDED|95.0|0.405|0.84|||Regression, Cox|||||0.840|0.405|0.0038
71091789|NCT03620162|141690118|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-0.6|||=|0.915|TWO_SIDED|95.0|-10.8|9.7|||Miettinen & Nurminen method|||Difference in Percentage: Tenderness(Group 4 vs 1)||9.7|-10.8|= 0.915
71091790|NCT03620162|141690118|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|1.9|||=|0.714|TWO_SIDED|95.0|-8.4|12.2|||Miettinen & Nurminen method|||Difference in Percentage: Tenderness(Group 3 vs 1)||12.2|-8.4|= 0.714
71091791|NCT03620162|141690118|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-0.5|||=|0.926|TWO_SIDED|95.0|-10.7|9.7|||Miettinen & Nurminen method|||Difference in Percentage: Tenderness(Group 2 vs 1)||9.7|-10.7|= 0.926
70969578|NCT02104583|141444859|SUPERIORITY||Eleclazine : Placebo Incident Rate Ratio|1.52||||0.152|TWO_SIDED|95.0|0.86|2.71|||generalized linear model|||The primary analysis of overall occurrence of appropriate ICD interventions through Week 24 was performed using a generalized linear model assuming a negative binomial distribution and log link. This model included terms for treatment, implanted device (ICD or CRT-D) and region \[US or rest of world (ROW)\].||2.71|0.86|0.152
70969579|NCT02104583|141444859|SUPERIORITY||Eleclazine : Placebo Incident Rate Ratio|0.82||||0.662|TWO_SIDED|95.0|0.34|1.97|||generalized linear model|||The primary analysis of overall occurrence of appropriate ICD interventions through Week 24 was performed using a generalized linear model assuming a negative binomial distribution and log link. This model included terms for treatment, implanted device (ICD or CRT-D) and region \[US or ROW\].||1.97|0.34|0.662
70969580|NCT02104583|141444859|SUPERIORITY||Eleclazine : Placebo Incident Rate Ratio|1.24||||0.618|TWO_SIDED|95.0|0.54|2.86|||generalized linear model|||The primary analysis of overall occurrence of appropriate ICD interventions through Week 24 was performed using a generalized linear model assuming a negative binomial distribution and log link. This model included terms for treatment, implanted device (ICD or CRT-D) and region \[US or ROW.||2.86|0.54|0.618
70969581|NCT02347098|141444869|SUPERIORITY|||||||0.2533|||||||t-test, 2 sided|||||||0.2533
70969582|NCT02347098|141444870|SUPERIORITY|||||||0.779|||||||t-test, 2 sided|||||||0.7790
70969583|NCT02347098|141444871|SUPERIORITY|||||||0.4549||||||The p-value reported compares the trends of outcome across time (baseline pre-PCI, baseline post-PCI, 30-day follow-up, and 90-day follow-up) between treatment groups using the repeated measurement analysis.|Mixed Models Analysis|||||||0.4549
70969584|NCT02347098|141444872|SUPERIORITY|||||||0.2663|||||||Fisher Exact|||||||0.2663
70969585|NCT02187172|141444873|SUPERIORITY||Mean Difference (Final Values)|-0.2456|STANDARD_ERROR_OF_MEAN|0.07||0.0012|TWO_SIDED|95.0|-0.3873|-0.104|||Regression, Linear|||Comparison during RCT period||-0.1040|-0.3873|0.0012
70969586|NCT02187172|141444873|SUPERIORITY||Mean Difference (Final Values)|-0.0151|STANDARD_ERROR_OF_MEAN|0.0353||0.6718|TWO_SIDED|95.0|-0.0867|0.0565|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||0.0565|-0.0867|0.6718
70969587|NCT02187172|141444874|SUPERIORITY||Mean Difference (Final Values)|-64.97|STANDARD_ERROR_OF_MEAN|44.88||0.1159|TWO_SIDED|95.0|-115.83|25.89|||Regression, Linear|||Comparison during RCT period||25.89|-115.83|0.1159
70969588|NCT02187172|141444874|SUPERIORITY||Mean Difference (Final Values)|6.65|STANDARD_ERROR_OF_MEAN|22.24||0.7666|TWO_SIDED|95.0|-38.41|51.72|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||51.72|-38.41|0.7666
70969589|NCT02187172|141444875|SUPERIORITY||Mean Difference (Final Values)|-80.89|STANDARD_ERROR_OF_MEAN|30.46||0.0115|TWO_SIDED|95.0|-142.55|-19.23|||Regression, Linear|||Comparison during RCT period||-19.23|-142.55|0.0115
70969590|NCT02187172|141444875|SUPERIORITY||Mean Difference (Final Values)|-1.99|STANDARD_ERROR_OF_MEAN|14.11||0.8883|TWO_SIDED|95.0|-30.58|26.59|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||26.59|-30.58|0.8883
70969591|NCT02187172|141444876|SUPERIORITY||Mean Difference (Final Values)|-3027.21|STANDARD_ERROR_OF_MEAN|3180.58||0.3472|TWO_SIDED|95.0|-9465.95|3411.54|||Regression, Linear|||Comparison during RCT period||3411.54|-9465.95|0.3472
70969592|NCT02187172|141444876|SUPERIORITY||Mean Difference (Final Values)|-1974.63|STANDARD_ERROR_OF_MEAN|1659.11||0.2416|TWO_SIDED|95.0|-5336.3|1387.04|||Regression, Linear|||Combined ustekinumab and placebo groups for active treatment period analysis.||1387.04|-5336.30|0.2416
70969593|NCT02187172|141444877|SUPERIORITY||Mean Difference (Final Values)|20.66|STANDARD_ERROR_OF_MEAN|24.75||0.6742|TWO_SIDED|95.0|-78.03|119.34|||Regression, Linear|||Comparison during RCT period||119.34|-78.03|0.6742
70969594|NCT02187172|141444877|SUPERIORITY||Mean Difference (Final Values)|47.0|STANDARD_ERROR_OF_MEAN|35.84||0.1979|TWO_SIDED|95.0|-25.63|11963.0|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||11963|-25.63|0.1979
70969595|NCT02187172|141444878|SUPERIORITY||Mean Difference (Final Values)|-7884.29|STANDARD_ERROR_OF_MEAN|7780.29||0.3173|TWO_SIDED|95.0|-23634.67|7566.1|||Regression, Linear|||Comparison during RCT period||7566.10|-23634.67|0.3173
70969596|NCT02187172|141444878|SUPERIORITY||Mean Difference (Final Values)|-3782.54|STANDARD_ERROR_OF_MEAN|4073.25||0.3591|TWO_SIDED|95.0|-12035.72|4470.64|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||4470.64|-12035.72|0.3591
70969597|NCT02187172|141444879|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|2.54||0.9767|TWO_SIDED|95.0|-5.22|5.07|||Regression, Linear|||Comparison during RCT period||5.07|-5.22|0.9767
70969598|NCT02187172|141444879|SUPERIORITY||Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|1.09||0.3205|TWO_SIDED|95.0|-3.29|1.11|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||1.11|-3.29|0.3205
70969599|NCT02187172|141444880|SUPERIORITY||Mean Difference (Final Values)|-14.79|STANDARD_ERROR_OF_MEAN|19.96||0.4632|TWO_SIDED|95.0|-55.19|25.61|||Regression, Linear|||Comparison during RCT period||25.61|-55.19|0.4632
70969600|NCT02187172|141444880|SUPERIORITY||Mean Difference (Final Values)|-7.24|STANDARD_ERROR_OF_MEAN|11.47||0.5316|TWO_SIDED|95.0|-30.47|15.99|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||15.99|-30.47|0.5316
70969601|NCT02187172|141444881|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.68||0.1928|TWO_SIDED|95.0|-2.27|0.47|||Regression, Linear|||Comparison during RCT period||0.47|-2.27|0.1928
71091792|NCT03620162|141690118|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.0|||>|0.999|TWO_SIDED|95.0|-8.7|8.7|||Miettinen & Nurminen method|||Difference in Percentage: Swelling(Group 5 vs 1)||8.7|-8.7|> 0.999
71091793|NCT03620162|141690118|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-2.2|||=|0.609|TWO_SIDED|95.0|-10.8|6.4|||Miettinen & Nurminen method|||Difference in Percentage: Swelling(Group 4 vs 1)||6.4|-10.8|= 0.609
70969602|NCT02187172|141444881|SUPERIORITY||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.34||0.058|TWO_SIDED|95.0|-1.36|0.02|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||0.02|-1.36|0.0580
70969603|NCT02187172|141444882|SUPERIORITY||Mean Difference (Final Values)|-4.14|STANDARD_ERROR_OF_MEAN|11.41||0.7185|TWO_SIDED|95.0|-27.24|18.96|||Regression, Linear|||Comparison during RCT period||18.96|-27.24|0.7185
70969604|NCT02187172|141444882|SUPERIORITY||Mean Difference (Final Values)|-8.35|STANDARD_ERROR_OF_MEAN|8.41||0.3271|TWO_SIDED|95.0|-25.4|8.69|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||8.69|-25.40|0.3271
70969605|NCT02187172|141444883|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.51||0.3124|TWO_SIDED|95.0|-1.56|0.51|||Regression, Linear|||Comparison during RCT period||0.51|-1.56|0.3124
70969606|NCT02187172|141444883|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.11||0.0106|TWO_SIDED|95.0|-0.54|-0.08|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||-0.08|-0.54|0.0106
70969607|NCT02187172|141444884|SUPERIORITY||Mean Difference (Final Values)|-70.76|STANDARD_ERROR_OF_MEAN|33.42||0.0408|TWO_SIDED|95.0|-138.42|-3.11|||Regression, Linear|||Comparison during RCT period||-3.11|-138.42|0.0408
70969608|NCT02187172|141444884|SUPERIORITY||Mean Difference (Final Values)|71.72|STANDARD_ERROR_OF_MEAN|132.87||0.5926|TWO_SIDED|95.0|-197.5|340.93|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||340.93|-197.50|0.5926
70969609|NCT02187172|141444885|SUPERIORITY||Mean Difference (Final Values)|191.49|STANDARD_ERROR_OF_MEAN|46.1||0.0002|TWO_SIDED|95.0|98.18|284.81|||Regression, Linear|||Comparison during RCT period||284.81|98.18|0.0002
70969610|NCT02187172|141444885|SUPERIORITY||Mean Difference (Final Values)|171.21|STANDARD_ERROR_OF_MEAN|20.3|<|0.0001|TWO_SIDED|95.0|130.08|212.34|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||212.34|130.08|<0.0001
70969611|NCT02187172|141444886|SUPERIORITY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|0.98||0.011|TWO_SIDED|95.0|-4.62|-0.64|||Regression, Linear|||Comparison during RCT period||-0.64|-4.62|0.0110
70969612|NCT02187172|141444886|SUPERIORITY||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|0.32||0.0008|TWO_SIDED|95.0|-1.79|-0.51|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||-0.51|-1.79|0.0008
70969613|NCT02187172|141444887|SUPERIORITY||Mean Difference (Final Values)|-155.31|STANDARD_ERROR_OF_MEAN|688.28||0.8227|TWO_SIDED|95.0|-1548.66|1238.04|||Regression, Linear|||Comparison during RCT period||1238.04|-1548.66|0.8227
70969614|NCT02187172|141444887|SUPERIORITY||Mean Difference (Final Values)|-407.43|STANDARD_ERROR_OF_MEAN|180.7||0.0302|TWO_SIDED|95.0|-773.57|-41.29|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||-41.29|-773.57|0.0302
70969615|NCT02187172|141444888|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|-0.47||0.2333|TWO_SIDED|95.0|-1.25|0.32|||Regression, Linear|||Comparison during RCT period||0.32|-1.25|0.2333
70969616|NCT02187172|141444888|SUPERIORITY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.21||0.0713|TWO_SIDED|95.0|-0.8|0.03|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||0.03|-0.80|0.0713
70969617|NCT02187172|141444889|SUPERIORITY||Mean Difference (Final Values)|-16.87|STANDARD_ERROR_OF_MEAN|15.62||0.2869|TWO_SIDED|95.0|-48.48|14.75|||Regression, Linear|||Comparison during RCT period||14.75|-48.48|0.2869
70969618|NCT02187172|141444889|SUPERIORITY||Mean Difference (Final Values)|-2.23|STANDARD_ERROR_OF_MEAN|1.71||0.1988|TWO_SIDED|95.0|-5.69|1.22|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||1.22|-5.69|0.1988
70969619|NCT02187172|141444890|SUPERIORITY||Mean Difference (Final Values)|2.06|STANDARD_ERROR_OF_MEAN|12.91||0.8744|TWO_SIDED|95.0|-24.09|28.2|||Regression, Linear|||Comparison during RCT period||28.20|-24.09|0.8744
70969620|NCT02187172|141444890|SUPERIORITY||Mean Difference (Final Values)|10.55|STANDARD_ERROR_OF_MEAN|8.26||0.2093|TWO_SIDED|95.0|-6.18|27.29|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||27.29|-6.18|0.2093
70969621|NCT02187172|141444891|SUPERIORITY||Mean Difference (Final Values)|19.2|STANDARD_ERROR_OF_MEAN|7.41||0.0135|TWO_SIDED|95.0|4.21|34.2|||Regression, Linear|||Comparison during RCT period||34.20|4.21|0.0135
70969622|NCT02187172|141444891|SUPERIORITY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|4.14||0.8499|TWO_SIDED|95.0|-9.19|7.61|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||7.61|-9.19|0.8499
70969623|NCT02187172|141444892|SUPERIORITY||Mean Difference (Final Values)|3.66|STANDARD_ERROR_OF_MEAN|1.96||0.0693|TWO_SIDED|95.0|-0.3|7.62|||Regression, Linear|||Comparison during RCT period||7.62|-0.30|0.0693
70969624|NCT02187172|141444892|SUPERIORITY||Mean Difference (Final Values)|1.92|STANDARD_ERROR_OF_MEAN|1.42||0.1841|TWO_SIDED|95.0|-0.96|4.8|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||4.80|-0.96|0.1841
70969625|NCT02187172|141444893|SUPERIORITY||Mean Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|1.03||0.2305|TWO_SIDED|95.0|-0.83|3.34|||Regression, Linear|||Comparison during RCT period||3.34|-0.83|0.2305
70969626|NCT02187172|141444893|SUPERIORITY||Mean Difference (Final Values)|0.91|STANDARD_ERROR_OF_MEAN|0.72||0.2189|TWO_SIDED|95.0|-0.53|2.37|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||2.37|-0.53|0.2189
70969627|NCT02187172|141444894|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.11||0.3212|TWO_SIDED|95.0|-0.34|0.11|||Regression, Linear|||Comparison during RCT period||0.11|-0.34|0.3212
70969628|NCT02187172|141444894|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.07||0.0137|TWO_SIDED|95.0|0.04|0.31|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||0.31|0.04|0.0137
70969629|NCT02187172|141444895|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.6||0.8383|TWO_SIDED|95.0|-1.09|1.33|||Regression, Linear|||Comparison during RCT period||1.33|-1.09|0.8383
70969630|NCT02187172|141444895|SUPERIORITY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.36||0.1651|TWO_SIDED|95.0|-0.22|1.24|||Regression, Logistic|||Global change from baseline after 52 weeks of active treatment.||1.24|-0.22|0.1651
70969631|NCT02187172|141444896|SUPERIORITY||Mean Difference (Final Values)|2.49|STANDARD_ERROR_OF_MEAN|1.7||0.1502|TWO_SIDED|95.0|-0.94|5.93|||Regression, Linear|||Comparison during RCT period||5.93|-0.94|0.1502
70969632|NCT02187172|141444896|SUPERIORITY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.84||0.8054|TWO_SIDED|95.0|-1.49|1.91|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||1.91|-1.49|0.8054
70969633|NCT02187172|141444897|SUPERIORITY||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|1.69||0.4235|TWO_SIDED|95.0|-4.79|2.05|||Regression, Linear|||Comparison during RCT period||2.05|-4.79|0.4235
70969634|NCT02187172|141444897|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.97||0.8653|TWO_SIDED|95.0|-1.8|2.13|||Regression, Linear|||Comparison during RCT period||2.13|-1.80|0.8653
70969635|NCT02187172|141444898|SUPERIORITY||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|1.89||0.558|TWO_SIDED|95.0|-4.95|2.71|||Regression, Linear|||Comparison during RCT period||2.71|-4.95|0.5580
70969636|NCT02187172|141444898|SUPERIORITY||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|1.0||0.4454|TWO_SIDED|95.0|-1.25|2.8|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||2.80|-1.25|0.4454
70969637|NCT02187172|141444899|SUPERIORITY||Mean Difference (Final Values)|21.37|STANDARD_ERROR_OF_MEAN|6.67||0.0027|TWO_SIDED|95.0|7.86|34.87|||Regression, Linear|||Comparison during RCT period||34.87|7.86|0.0027
70969638|NCT02187172|141444899|SUPERIORITY||Mean Difference (Final Values)|-2.92|STANDARD_ERROR_OF_MEAN|4.07||0.4775|TWO_SIDED|95.0|-11.17|5.33|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||5.33|-11.17|0.4775
70969639|NCT02187172|141444900|SUPERIORITY||Mean Difference (Final Values)|230.77|STANDARD_ERROR_OF_MEAN|69.8||0.0021|TWO_SIDED|95.0|89.47|372.08|||Regression, Linear|||Comparison during RCT period||372.08|89.47|0.0021
70969640|NCT02187172|141444900|SUPERIORITY||Mean Difference (Final Values)|-31.89|STANDARD_ERROR_OF_MEAN|41.71||0.4493|TWO_SIDED|95.0|-116.4|52.61|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||52.61|-116.40|0.4493
70969641|NCT02187172|141444901|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.17||0.8008|TWO_SIDED|95.0|-0.3|0.38|||Regression, Linear|||Comparison during RCT period||0.38|-0.30|0.8008
70969642|NCT02187172|141444901|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.11||0.8068|TWO_SIDED|95.0|-0.19|0.24|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||0.24|-0.19|0.8068
70969643|NCT02187172|141444902|SUPERIORITY||Mean Difference (Final Values)|46.96|STANDARD_ERROR_OF_MEAN|56.12||0.4079|TWO_SIDED|95.0|-66.65|160.57|||Regression, Logistic|||Comparison during RCT period||160.57|-66.65|0.4079
70969644|NCT02187172|141444902|SUPERIORITY||Mean Difference (Final Values)|4.68|STANDARD_ERROR_OF_MEAN|33.85||0.8907|TWO_SIDED|95.0|-63.91|73.28|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||73.28|-63.91|0.8907
70969645|NCT02187172|141444903|SUPERIORITY||Mean Difference (Final Values)|7.01|STANDARD_ERROR_OF_MEAN|48.81||0.8866|TWO_SIDED|95.0|-91.8|105.81|||Regression, Linear|||Comparison during RCT period||105.81|-91.80|0.8866
70969646|NCT02187172|141444903|SUPERIORITY||Mean Difference (Final Values)|-24.74|STANDARD_ERROR_OF_MEAN|32.59||0.4527|TWO_SIDED|95.0|-90.78|41.3|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||41.30|-90.78|0.4527
70969647|NCT02187172|141444904|SUPERIORITY||Mean Difference (Final Values)|194.69|STANDARD_ERROR_OF_MEAN|66.23||0.0056|TWO_SIDED|95.0|60.61|328.77|||Regression, Linear|||Comparison during RCT period||328.77|60.61|0.0056
70969648|NCT02187172|141444904|SUPERIORITY||Mean Difference (Final Values)|-29.16|STANDARD_ERROR_OF_MEAN|38.01||0.4478|TWO_SIDED|95.0|-106.17|47.85|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||47.85|-106.17|0.4478
70969649|NCT02187172|141444905|SUPERIORITY||Mean Difference (Final Values)|3.14|STANDARD_ERROR_OF_MEAN|2.81||0.2704|TWO_SIDED|95.0|-2.55|8.83|||Regression, Linear|||Comparison during RCT period||8.83|-2.55|0.2704
70969650|NCT02187172|141444905|SUPERIORITY||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|1.41||0.295|TWO_SIDED|95.0|-1.36|4.36|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||4.36|-1.36|0.2950
70969651|NCT02187172|141444906|SUPERIORITY||Mean Difference (Final Values)|-16.74|STANDARD_ERROR_OF_MEAN|6.57||0.0149|TWO_SIDED|95.0|-30.03|-3.45|||Regression, Linear|||Comparison during RCT period||-3.45|-30.03|0.0149
70969652|NCT02187172|141444906|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|3.37||0.9734|TWO_SIDED|95.0|-6.93|6.71|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||6.71|-6.93|0.9734
70969653|NCT02187172|141444907|SUPERIORITY||Mean Difference (Net)|-9.21|STANDARD_ERROR_OF_MEAN|11.76||0.4384|TWO_SIDED|95.0|-33.03|14.6|||Regression, Linear|||Comparison during RCT period||14.60|-33.03|0.4384
71091794|NCT03620162|141690118|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|1.8|||=|0.688|TWO_SIDED|95.0|-7.1|10.7|||Miettinen & Nurminen method|||Difference in Percentage: Swelling(Group 3 vs 1)||10.7|-7.1|= 0.688
71091795|NCT03620162|141690118|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-4.1|||=|0.336|TWO_SIDED|95.0|-12.6|4.3|||Miettinen & Nurminen method|||Difference in Percentage: Swelling(Group 2 vs 1)||4.3|-12.6|= 0.336
70969654|NCT02187172|141444907|SUPERIORITY||Mean Difference (Final Values)|11.14|STANDARD_ERROR_OF_MEAN|7.33||0.1373|TWO_SIDED|95.0|-3.72|25.99|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||25.99|-3.72|0.1373
70969655|NCT02187172|141444908|SUPERIORITY||Mean Difference (Final Values)|-15.71|STANDARD_ERROR_OF_MEAN|5.77||0.0097|TWO_SIDED|95.0|-27.39|-4.03|||Regression, Linear|||Comparison during RCT period||-4.03|-27.39|0.0097
70969656|NCT02187172|141444908|SUPERIORITY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|2.07||0.8119|TWO_SIDED|95.0|-4.69|3.7|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||3.70|-4.69|0.8119
70969657|NCT02187172|141444909|SUPERIORITY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|4.57||0.9415|TWO_SIDED|95.0|-8.91|9.59|||Regression, Linear|||Comparison during RCT period||9.59|-8.91|0.9415
70969658|NCT02187172|141444909|SUPERIORITY||Mean Difference (Final Values)|-1.86|STANDARD_ERROR_OF_MEAN|2.43||0.4485|TWO_SIDED|95.0|-6.77|3.06|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||3.06|-6.77|0.4485
70969659|NCT02187172|141444910|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|5.16||0.988|TWO_SIDED|95.0|-10.37|10.53|||Regression, Linear|||Comparison during RCT period||10.53|-10.37|0.9880
70969660|NCT02187172|141444910|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|2.59||0.8836|TWO_SIDED|95.0|-4.86|5.63|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||5.63|-4.86|0.8836
70969661|NCT02187172|141444911|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|1.3||0.8321|TWO_SIDED|95.0|-2.91|2.36|||Regression, Linear|||Comparison during RCT period||2.36|-2.91|0.8321
70969662|NCT02187172|141444911|SUPERIORITY||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|1.08||0.0394|TWO_SIDED|95.0|0.12|4.48|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||4.48|0.12|0.0394
70969663|NCT02187172|141444912|SUPERIORITY||Mean Difference (Final Values)|152.68|STANDARD_ERROR_OF_MEAN|43.76||0.0012|TWO_SIDED|95.0|64.07|241.23|||Regression, Linear|||Comparison during RCT period||241.23|64.07|0.0012
70969664|NCT02187172|141444912|SUPERIORITY||Mean Difference (Final Values)|-2.97|STANDARD_ERROR_OF_MEAN|25.7||0.9085|TWO_SIDED|95.0|-55.04|49.09|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||49.09|-55.04|0.9085
70969665|NCT02187172|141444913|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.04||0.1792|TWO_SIDED|95.0|-0.03|0.14|||Regression, Linear|||Comparison during RCT period||0.14|-0.03|0.1792
70969666|NCT02187172|141444913|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.03||0.2559|TWO_SIDED|95.0|-0.03|0.1|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||0.10|-0.03|0.2559
70969667|NCT02187172|141444914|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.13||0.2453|TWO_SIDED|95.0|-0.11|0.41|||Regression, Linear|||||0.41|-0.11|0.2453
70969668|NCT02187172|141444914|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.06||0.1087|TWO_SIDED|95.0|-0.02|0.23|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||0.23|-0.02|0.1087
70969669|NCT02187172|141444915|SUPERIORITY||Mean Difference (Final Values)|48.43|STANDARD_ERROR_OF_MEAN|61.62||0.4368|TWO_SIDED|95.0|-76.31|173.16|||Regression, Linear|||Comparison during RCT period||173.16|-76.31|0.4368
70969670|NCT02187172|141444915|SUPERIORITY||Mean Difference (Final Values)|-49.56|STANDARD_ERROR_OF_MEAN|27.84||0.0833|TWO_SIDED|95.0|-105.97|6.85|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||6.85|-105.97|0.0833
70969671|NCT02187172|141444916|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|1.11||0.8036|TWO_SIDED|95.0|-2.52|1.97|||Regression, Linear|||Comparison during RCT period||1.97|-2.52|0.8036
71091796|NCT03620162|141690119|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-1.1|||=|0.825|TWO_SIDED|95.0|-11.0|8.8|||Miettinen & Nurminen method|||Difference in Percentage:Appetite lost(Group5 vs1)||8.8|-11.0|= 0.825
71091797|NCT03620162|141690119|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-0.6|||=|0.912|TWO_SIDED|95.0|-10.4|9.3|||Miettinen & Nurminen method|||Difference in Percentage:Appetite lost(Group4 vs1)||9.3|-10.4|= 0.912
71091798|NCT03620162|141690119|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-8.8|||=|0.074|TWO_SIDED|95.0|-18.3|0.9|||Miettinen & Nurminen method|||Difference in Percentage:Appetite lost(Group3 vs1)||0.9|-18.3|= 0.074
71091799|NCT03620162|141690119|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Percentage of Participants|-3.7|||=|0.458|TWO_SIDED|95.0|-13.4|6.1|||Miettinen & Nurminen method|||Difference in Percentage:Appetite lost(Group2 vs1)||6.1|-13.4|= 0.458
71091800|NCT03620162|141690119|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|2.8|||=|0.568|TWO_SIDED|95.0|-6.8|12.3|||Miettinen & Nurminen method|||Difference in Percentage:Irritability(Group 5 vs1)||12.3|-6.8|= 0.568
71091801|NCT03620162|141690119|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.6|||=|0.91|TWO_SIDED|95.0|-9.1|10.2|||Miettinen & Nurminen method|||Difference in Percentage:Irritability(Group 4 vs1)||10.2|-9.1|= 0.910
71091802|NCT03620162|141690119|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-4.7|||=|0.354|TWO_SIDED|95.0|-14.5|5.2|||Miettinen & Nurminen method|||Difference in Percentage:Irritability(Group 3 vs1)||5.2|-14.5|= 0.354
71091803|NCT03620162|141690119|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-6.8|||=|0.178|TWO_SIDED|95.0|-16.6|3.1|||Miettinen & Nurminen method|||Difference in Percentage:Irritability(Group 2 vs1)||3.1|-16.6|= 0.178
71091804|NCT03620162|141690119|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|3.4|||=|0.52|TWO_SIDED|95.0|-6.8|13.5|||Miettinen & Nurminen method|||Difference in Percentage: Drowsiness(Group 5 vs 1)||13.5|-6.8|= 0.520
71091805|NCT03620162|141690119|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.0|||>|0.999|TWO_SIDED|95.0|-10.2|10.2|||Miettinen & Nurminen method|||Difference in Percentage: Drowsiness(Group 4 vs 1)||10.2|-10.2|> 0.999
71091806|NCT03620162|141690119|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-0.2|||=|0.963|TWO_SIDED|95.0|-10.5|10.0|||Miettinen & Nurminen method|||Difference in Percentage: Drowsiness(Group 3 vs 1)||10.0|-10.5|= 0.963
71091807|NCT03620162|141690119|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-1.2|||=|0.821|TWO_SIDED|95.0|-11.4|9.0|||Miettinen & Nurminen method|||Difference in Percentage: Drowsiness(Group 2 vs 1)||9.0|-11.4|= 0.821
71091808|NCT03620162|141690119|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-0.6|||=|0.836|TWO_SIDED|95.0|-6.1|5.0|||Miettinen & Nurminen method|||Difference in Percentage: Hives(Group 5 vs 1)||5.0|-6.1|= 0.836
71091809|NCT03620162|141690119|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|1.7|||=|0.562|TWO_SIDED|95.0|-4.2|7.6|||Miettinen & Nurminen method|||Difference in Percentage: Hives(Group 4 vs 1)||7.6|-4.2|= 0.562
71091810|NCT03620162|141690119|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-1.6|||=|0.527|TWO_SIDED|95.0|-7.1|3.7|||Miettinen & Nurminen method|||Difference in Percentage: Hives(Group 3 vs 1)||3.7|-7.1|= 0.527
71091811|NCT03620162|141690119|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-3.4|||=|0.16|TWO_SIDED|95.0|-8.6|1.5|||Miettinen & Nurminen method|||Difference in Percentage: Hives(Group 2 vs 1)||1.5|-8.6|= 0.160
71091812|NCT03620162|141690120|OTHER|Estimated differences and CIs are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Difference in Percentage (Group 5 vs 1)||2.1|-2.1|
71091813|NCT03620162|141690120|OTHER|Estimated differences and CIs are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Difference in Percentage (Group 4 vs 1)||2.1|-2.1|
71091814|NCT03620162|141690120|OTHER|Estimated differences and CIs are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.6|||||TWO_SIDED|95.0|-1.6|3.1||||||Difference in Percentage (Group 3 vs 1)||3.1|-1.6|
71091815|NCT03620162|141690120|OTHER|Estimated differences and CIs are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Difference in Percentage (Group 2 vs 1)||2.1|-2.1|
71091816|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.69|1.0||||||GMC Ratio: Serotype 1 (Group 4 vs 1)||1.00|0.69|
71091817|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.93|||||TWO_SIDED|95.0|0.77|1.12||||||GMC Ratio: Serotype 1 (Group 3 vs 1)||1.12|0.77|
71091818|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.7|1.0||||||GMC Ratio: Serotype 1 (Group 2 vs 1)||1.00|0.70|
71091819|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.01|||||TWO_SIDED|95.0|0.86|1.19||||||GMC Ratio: Serotype 3 (Group 4 vs 1)||1.19|0.86|
71091820|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.94|||||TWO_SIDED|95.0|0.8|1.12||||||GMC Ratio: Serotype 3 (Group 3 vs 1)||1.12|0.80|
71091821|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.06|||||TWO_SIDED|95.0|0.9|1.25||||||GMC Ratio: Serotype 3 (Group 2 vs 1)||1.25|0.90|
71091822|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.81|||||TWO_SIDED|95.0|0.66|1.0||||||GMC Ratio: Serotype 4 (Group 4 vs 1)||1.00|0.66|
71091823|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.68|1.03||||||GMC Ratio: Serotype 4 (Group 3 vs 1)||1.03|0.68|
71091824|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.88|||||TWO_SIDED|95.0|0.72|1.08||||||GMC Ratio: Serotype 4 (Group 2 vs 1)||1.08|0.72|
71091825|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.64|0.98||||||GMC Ratio: Serotype 5 (Group 4 vs 1)||0.98|0.64|
71091826|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.04|||||TWO_SIDED|95.0|0.84|1.29||||||GMC Ratio: Serotype 5 (Group 3 vs 1)||1.29|0.84|
71091827|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.92|||||TWO_SIDED|95.0|0.75|1.14||||||GMC Ratio: Serotype 5 (Group 2 vs 1)||1.14|0.75|
71091828|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.8|||||TWO_SIDED|95.0|0.66|0.98||||||GMC Ratio: Serotype 6A (Group 4 vs 1)||0.98|0.66|
71091829|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.11|||||TWO_SIDED|95.0|0.91|1.37||||||GMC Ratio: Serotype 6A (Group 3 vs 1)||1.37|0.91|
71091830|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.12|||||TWO_SIDED|95.0|0.92|1.36||||||GMC Ratio: Serotype 6A (Group 2 vs 1)||1.36|0.92|
71091831|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.08|||||TWO_SIDED|95.0|0.88|1.31||||||GMC Ratio: Serotype 6B (Group 4 vs 1)||1.31|0.88|
71091832|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.08|||||TWO_SIDED|95.0|0.88|1.32||||||GMC Ratio: Serotype 6B (Group 3 vs 1)||1.32|0.88|
71091833|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.23|||||TWO_SIDED|95.0|1.02|1.49||||||GMC Ratio: Serotype 6B (Group 2 vs 1)||1.49|1.02|
71091834|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.78|||||TWO_SIDED|95.0|0.64|0.95||||||GMC Ratio: Serotype 7F (Group 4 vs 1)||0.95|0.64|
71091835|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.99|||||TWO_SIDED|95.0|0.81|1.21||||||GMC Ratio: Serotype 7F (Group 3 vs 1)||1.21|0.81|
71091836|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.11|||||TWO_SIDED|95.0|0.92|1.35||||||GMC Ratio: Serotype 7F (Group 2 vs 1)||1.35|0.92|
71091837|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.7|1.01||||||GMC Ratio: Serotype 9V (Group 4 vs 1)||1.01|0.70|
71091838|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.88|||||TWO_SIDED|95.0|0.73|1.06||||||GMC Ratio: Serotype 9V (Group 3 vs 1)||1.06|0.73|
71091839|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.94|||||TWO_SIDED|95.0|0.79|1.13||||||GMC Ratio: Serotype 9V (Group 2 vs 1)||1.13|0.79|
71091840|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.03|||||TWO_SIDED|95.0|0.83|1.28||||||GMC Ratio: Serotype 14 (Group 4 vs 1)||1.28|0.83|
71091841|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.43|||||TWO_SIDED|95.0|1.15|1.78||||||GMC Ratio: Serotype 14 (Group 3 vs 1)||1.78|1.15|
71091842|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.39|||||TWO_SIDED|95.0|1.13|1.71||||||GMC Ratio: Serotype 14 (Group 2 vs 1)||1.71|1.13|
71091843|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.07|||||TWO_SIDED|95.0|0.88|1.3||||||GMC Ratio: Serotype 18C (Group 4 vs 1)||1.30|0.88|
71091844|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.44|||||TWO_SIDED|95.0|1.18|1.76||||||GMC Ratio: Serotype 18C (Group 3 vs 1)||1.76|1.18|
71091845|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.51|||||TWO_SIDED|95.0|1.25|1.83||||||GMC Ratio: Serotype 18C (Group 2 vs 1)||1.83|1.25|
71091846|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.69|1.01||||||GMC Ratio: Serotype 19A (Group 4 vs 1)||1.01|0.69|
71091847|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.88|||||TWO_SIDED|95.0|0.72|1.07||||||GMC Ratio: Serotype 19A (Group 3 vs 1)||1.07|0.72|
71091848|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.93|||||TWO_SIDED|95.0|0.77|1.13||||||GMC Ratio: Serotype 19A (Group 2 vs 1)||1.13|0.77|
71091849|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.96|||||TWO_SIDED|95.0|0.81|1.15||||||GMC Ratio: Serotype 19F (Group 4 vs 1)||1.15|0.81|
71091850|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.05|||||TWO_SIDED|95.0|0.88|1.26||||||GMC Ratio: Serotype 19F (Group 3 vs 1)||1.26|0.88|
71091851|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.02|||||TWO_SIDED|95.0|0.86|1.21||||||GMC Ratio: Serotype 19F (Group 2 vs 1)||1.21|0.86|
71091852|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.77|||||TWO_SIDED|95.0|0.61|0.96||||||GMC Ratio: Serotype 23F (Group 4 vs 1)||0.96|0.61|
71091853|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.63|0.99||||||GMC Ratio: Serotype 23F (Group 3 vs 1)||0.99|0.63|
71091854|NCT03620162|141690121|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.94|||||TWO_SIDED|95.0|0.76|1.17||||||GMC Ratio: Serotype 23F (Group 2 vs 1)||1.17|0.76|
71091855|NCT03620162|141690122|NON_INFERIORITY|The statistical criterion for non-inferiority requires the lower bound of the 2-sided 95% CI for the difference in percentages (Group 5/Group 1+Group 2) to be \>-10 percentage points.|Difference in Percentage|-0.2|||<|0.001|TWO_SIDED|95.0|-3.7|2.0|||Miettinen & Nurminen method|||Difference in Percentage (Group 5 vs Group 1+2)||2.0|-3.7|< 0.001
71091856|NCT03620162|141690123|NON_INFERIORITY|The statistical criterion for non-inferiority requires the lower bound of the 2-sided 95% CI for the GMT ratio (Group 5/Group 1+Group 2) to be \>0.5.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.7|1.34|||ANCOVA|||GMT Ratio (Group 5 vs Group 1+2)||1.34|0.70|< 0.001
71091857|NCT03620162|141690126|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.72|||||TWO_SIDED|95.0|0.6|0.86||||||GMC Ratio: Serotype 1 (Group 5 vs 1)||0.86|0.60|
71091858|NCT03620162|141690126|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.22|||||TWO_SIDED|95.0|1.04|1.44||||||GMC Ratio: Serotype 3 (Group 5 vs 1)||1.44|1.04|
71091859|NCT03620162|141690126|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.89|||||TWO_SIDED|95.0|0.73|1.1||||||GMC Ratio: Serotype 4 (Group 5 vs 1)||1.10|0.73|
71091860|NCT03620162|141690126|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.64|0.97||||||GMC Ratio: Serotype 5 (Group 5 vs 1)||0.97|0.64|
71091861|NCT03620162|141690126|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.69|||||TWO_SIDED|95.0|0.57|0.84||||||GMC Ratio: Serotype 6A (Group 5 vs 1)||0.84|0.57|
71091862|NCT03620162|141690126|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.95|||||TWO_SIDED|95.0|0.78|1.15||||||GMC Ratio: Serotype 6B (Group 5 vs 1)||1.15|0.78|
71091863|NCT03620162|141690126|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.67|||||TWO_SIDED|95.0|0.55|0.82||||||GMC Ratio: Serotype 7F (Group 5 vs 1)||0.82|0.55|
71091864|NCT03620162|141690126|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.99|||||TWO_SIDED|95.0|0.82|1.18||||||GMC Ratio: Serotype 9V (Group 5 vs 1)||1.18|0.82|
71091865|NCT03620162|141690126|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.86|||||TWO_SIDED|95.0|0.7|1.07||||||GMC Ratio: Serotype 14 (Group 5 vs 1)||1.07|0.70|
71091866|NCT03620162|141690126|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.03|||||TWO_SIDED|95.0|0.85|1.25||||||GMC Ratio: Serotype 18C (Group 5 vs 1)||1.25|0.85|
71091867|NCT03620162|141690126|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.65|0.95||||||GMC Ratio: Serotype 19A (Group 5 vs 1)||0.95|0.65|
71091868|NCT03620162|141690126|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.86|||||TWO_SIDED|95.0|0.72|1.02||||||GMC Ratio: Serotype 19F (Group 5 vs 1)||1.02|0.72|
71091869|NCT03620162|141690126|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.73|||||TWO_SIDED|95.0|0.59|0.91||||||GMC Ratio: Serotype 23F (Group 5 vs 1)||0.91|0.59|
71091870|NCT03416179|141690141|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.6579|TWO_SIDED|95.0|0.755|1.532|||Log Rank|||Hazard ratio based on Cox proportional hazards model; under proportional hazards, hazard ratio less than (\<) 1 indicated a reduction in hazard rate in favor of Glasdegib 100 mg PO + Cytarabine 100 mg/m\^2 IV + Daunorubicin 60 mg/m\^2 compared to Placebo + Cytarabine 100 mg/m\^2 IV + Daunorubicin 60 mg/m\^2.||1.532|0.755|0.6579
71091871|NCT03416179|141690142|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.5955|TWO_SIDED|95.0|0.775|1.388|||Log Rank|||Hazard ratio based on Cox proportional hazards model; under proportional hazards, hazard ratio \< 1 indicated a reduction in hazard rate in favor of Glasdegib 100 mg PO QD + Azacitidine compared to Placebo + Azacitidine||1.388|0.775|0.5955
71091872|NCT03416179|141690143|OTHER|||||||0.5095|||||||Mantel Haenszel|||||||0.5095
71091873|NCT03416179|141690144|OTHER|||||||0.8359|||||||Mantel Haenszel|||||||0.8359
71091874|NCT01138735|141690203|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No adjustment for multiplicity is required. The tests will be conducted as two-sided, each at the 0.05 significance level. The trial will be claimed 'positive' if all primary analyses are shown statistically significant at the 0.05 level.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH) test stratified by analysis center, using general association statistics||"null hypothesis: no difference in Success rate in two treatment groups (adapalene/benzoyl peroxide vs Topical Gel Vehicle).~power calculation: 90%"||||<0.001
71091875|NCT01138735|141690204|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No adjustment for multiplicity is required. The tests will be conducted as two-sided, each at the 0.05 significance level. The trial will be claimed 'positive' if all primary analyses are shown statistically significant at the 0.05 level.|ANCOVA|normality assumption is not met. ANCOVA Model: Ranked Change in Total Lesion Counts = Ranked Baseline Lesion Counts, Analysis Center, Treatment.||null hypothesis: no difference in change from baseline in total lesion count in two treatment groups (adapalene/benzoyl peroxide vs Topical Gel Vehicle)||||<0.001
71091876|NCT01138735|141690205|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|CMH test with row mean difference statistic using relative to an identified distribution(RIDIT) score, controlling for analysis center||||||<0.001
71091877|NCT01138735|141690206|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|Ranked Change in Inflammatory Lesion Counts = Ranked Baseline Inflammatory Lesion Counts, Analysis Center, Treatment||||||<0.001
71091878|NCT00846365|141690284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1|||<|0.001|TWO_SIDED|95.0|-8.4|-3.8||Statistical significance was set at the 0.05 level per the predefined stepwise testing strategy used.|ANCOVA|||Analysis of Covariance (ANCOVA) model with treatment as a fixed effect and Baseline as a covariate.||-3.8|-8.4|<0.001
71091879|NCT00846365|141690284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||<|0.001|TWO_SIDED|95.0|-9.1|-4.4||Statistical significance was set at the 0.05 level per the predefined stepwise testing strategy used.|ANCOVA|||ANCOVA model with treatment as a fixed effect and Baseline as a covariate.||-4.4|-9.1|<0.001
71091880|NCT00846365|141690285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1|||<|0.001|TWO_SIDED|95.0|-8.5|-3.7||Statistical significance was set at the 0.05 level per the predefined stepwise testing strategy used.|ANCOVA|||ANCOVA model with treatment as a fixed effect and Baseline as a covariate.||-3.7|-8.5|<0.001
71091881|NCT00846365|141690285|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-7.2|||<|0.001|TWO_SIDED|95.0|-9.6|-4.8||Statistical significance was set at the 0.05 level per the predefined stepwise testing strategy used.|ANCOVA|||ANCOVA model with treatment as a fixed effect and Baseline as a covariate.||-4.8|-9.6|<0.001
71091882|NCT00846365|141690289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6|||<|0.001|TWO_SIDED|95.0|-7.5|-3.7||Tested at the 0.05 significance level.|ANCOVA|||Statistical analysis for Week 8. ANOVA model with treatment as a fixed effect. Post-baseline p-values are obtained from an ANCOVA model with treatment as a fixed effect and baseline as a covariate.||-3.7|-7.5|<0.001
71091883|NCT00846365|141690289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.2|||<|0.001|TWO_SIDED|95.0|-9.1|-5.2||Tested at the 0.05 significance level.|ANCOVA|||Statistical analysis for Week 8. ANOVA model with treatment as a fixed effect. Post-baseline p-values are obtained from an ANCOVA model with treatment as a fixed effect and baseline as a covariate.||-5.2|-9.1|<0.001
71091884|NCT03100747|141690317|SUPERIORITY||Odds Ratio (OR)|1.21||||0.039|TWO_SIDED|98.3|0.97|1.52||The a priori threshold for statistical significance (adjusted for multiple comparisons) is 0.0167.|Regression, Logistic|||||1.52|0.97|0.039
71091885|NCT03100747|141690317|SUPERIORITY||Odds Ratio (OR)|1.91|||<|0.0001|TWO_SIDED|98.3|1.54|2.36||The a priori threshold for statistical significance (adjusted for multiple comparisons) is 0.0167.|Regression, Logistic|||||2.36|1.54|<0.0001
71091886|NCT03100747|141690317|SUPERIORITY||Odds Ratio (OR)|1.57|||<|0.0001|TWO_SIDED|98.3|1.29|1.92||The a priori threshold for statistical significance (adjusted for multiple comparisons) is 0.0167.|Regression, Logistic|||||1.92|1.29|<0.0001
71091887|NCT03100747|141690322|SUPERIORITY||Odds Ratio (OR)|0.84||||0.094|TWO_SIDED|98.3|0.65|1.08||p-values adjusted for multiple comparisons|Regression, Logistic|||||1.08|0.65|0.094
71091888|NCT03100747|141690322|SUPERIORITY||Odds Ratio (OR)|0.5|||<|0.0001|TWO_SIDED|98.3|0.38|0.67||p-value adjusted for multiple comparisons, the a priori threshold for statistical significance (adjusted for multiple comparisons) is 0.0167.|Regression, Logistic|||||0.67|0.38|<0.0001
71091889|NCT03100747|141690322|SUPERIORITY||Odds Ratio (OR)|0.6|||<|0.0001|TWO_SIDED|98.3|0.45|0.8||The a priori threshold for statistical significance (adjusted for multiple comparisons) is 0.0167.|Regression, Logistic|||||0.80|0.45|<0.0001
71091890|NCT03100747|141690327|SUPERIORITY||Odds Ratio (OR)|0.86||||0.24|TWO_SIDED|98.3|0.64|1.17|||Regression, Logistic|||||1.17|0.64|0.24
71091891|NCT03100747|141690327|SUPERIORITY||Odds Ratio (OR)|0.68||||0.0037|TWO_SIDED|98.3|0.49|0.93|||Regression, Logistic|||||0.93|0.49|0.0037
71091892|NCT03100747|141690327|SUPERIORITY||Odds Ratio (OR)|0.78||||0.08|TWO_SIDED|98.3|0.57|1.09|||Regression, Logistic|||||1.09|0.57|0.08
71091893|NCT02696798|141690372|SUPERIORITY||Odds Ratio (OR)|2.41||||0.017|TWO_SIDED|95.0|1.17|4.95|||Regression, Logistic|||||4.95|1.17|0.017
71091894|NCT02696798|141690372|SUPERIORITY||Odds Ratio (OR)|3.06||||0.003|TWO_SIDED|95.0|1.48|6.33|||Regression, Logistic|||||6.33|1.48|0.003
71091895|NCT02696798|141690373|SUPERIORITY||Odds Ratio (OR)|2.2||||0.006|TWO_SIDED|95.0|1.26|3.84|||Regression, Logistic|||||3.84|1.26|0.006
71091896|NCT02696798|141690373|SUPERIORITY||Odds Ratio (OR)|2.08||||0.013|TWO_SIDED|95.0|1.16|3.73|||Regression, Logistic|||||3.73|1.16|0.013
71091897|NCT02696798|141690374|SUPERIORITY||LS Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.135|<|0.001|TWO_SIDED|95.0|-1.32|-0.79|||Mixed Models Analysis|||||-0.79|-1.32|<0.001
71091898|NCT02696798|141690374|SUPERIORITY||LS Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.3|-0.75|||Mixed Models Analysis|||||-0.75|-1.30|<0.001
71091899|NCT02696798|141690375|SUPERIORITY||Odds Ratio (OR)|2.65||||0.015|TWO_SIDED|95.0|1.21|5.84|||Regression, Logistic|||||5.84|1.21|0.015
71091900|NCT02696798|141690375|SUPERIORITY||Odds Ratio (OR)|2.9||||0.01|TWO_SIDED|95.0|1.29|6.49|||Regression, Logistic|||||6.49|1.29|0.010
71091901|NCT02696798|141690376|SUPERIORITY||LS Mean Difference (Final Values)|-1.24|STANDARD_ERROR_OF_MEAN|0.291|<|0.001|TWO_SIDED|95.0|-1.81|-0.67|||Mixed Models Analysis|||||-0.67|-1.81|<0.001
71091902|NCT02696798|141690376|SUPERIORITY||LS Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|0.301|<|0.001|TWO_SIDED|95.0|-1.76|-0.57|||Mixed Models Analysis|||||-0.57|-1.76|<0.001
71091903|NCT02696798|141690377|SUPERIORITY||LS Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.295|<|0.001|TWO_SIDED|95.0|-1.63|-0.47|||Mixed Models Analysis|||||-0.47|-1.63|<0.001
71091904|NCT02696798|141690377|SUPERIORITY||LS Mean Difference (Final Values)|-1.28|STANDARD_ERROR_OF_MEAN|0.307|<|0.001|TWO_SIDED|95.0|-1.89|-0.68|||Mixed Models Analysis|||||-0.68|-1.89|<0.001
71091905|NCT02696798|141690378|SUPERIORITY||Odds Ratio (OR)|3.73||||0.242|TWO_SIDED|95.0|0.41|33.98|||Regression, Logistic|||||33.98|0.41|0.242
71091906|NCT02696798|141690378|SUPERIORITY||Odds Ratio (OR)|5.42||||0.127|TWO_SIDED|95.0|0.62|47.54|||Regression, Logistic|||||47.54|0.62|0.127
71091907|NCT02696798|141690379|SUPERIORITY||Odds Ratio (OR)|4.22||||0.006|TWO_SIDED|95.0|1.5|11.86|||Regression, Logistic|||||11.86|1.50|0.006
71091908|NCT02696798|141690379|SUPERIORITY||Odds Ratio (OR)|4.52||||0.006|TWO_SIDED|95.0|1.55|13.18|||Regression, Logistic|||||13.18|1.55|0.006
71091909|NCT02696798|141690380|SUPERIORITY||LS Mean Difference (Final Values)|0.7689|STANDARD_ERROR_OF_MEAN|1.2863||0.55|TWO_SIDED|95.0|-1.7629|3.3007|||Mixed Models Analysis|||MCS||3.3007|-1.7629|0.550
71091910|NCT02696798|141690380|SUPERIORITY||LS Mean Difference (Final Values)|0.9104|STANDARD_ERROR_OF_MEAN|1.3338||0.495|TWO_SIDED|95.0|-1.7151|3.536|||Mixed Models Analysis|||MCS||3.5360|-1.7151|0.495
71152356|NCT04672655|141796893|OTHER|||||||0.8875||||||The a priori threshold for statistical significance was \< 0.05.|linear mixed effects models|||A linear mixed effects model (LMM) was used to examine outcomes measured at 3, 6, and 12 months. An unstructured covariance matrix was specified to model within-subject correlations across repeated measurements. To address missing data, the LMM utilized a likelihood-based approach under the missing-at-random (MAR) assumption, which incorporates all available data, thereby minimizing bias from incomplete follow-up measurements.||||0.8875
71152357|NCT04672655|141796894|OTHER|||||||0.4811||||||The a priori threshold for statistical significance was \< 0.05.|linear mixed effects models|||A linear mixed effects model (LMM) was used to examine outcomes measured at 3, 6, and 12 months. An unstructured covariance matrix was specified to model within-subject correlations across repeated measurements. To address missing data, the LMM utilized a likelihood-based approach under the missing-at-random (MAR) assumption, which incorporates all available data, thereby minimizing bias from incomplete follow-up measurements.||||0.4811
71152358|NCT04672655|141796895|OTHER|||||||0.754||||||The a priori threshold for statistical significance was \< 0.05.|linear mixed effects models|||A linear mixed effects model (LMM) was used to examine outcomes measured at 3, 6, and 12 months. An unstructured covariance matrix was specified to model within-subject correlations across repeated measurements. To address missing data, the LMM utilized a likelihood-based approach under the missing-at-random (MAR) assumption, which incorporates all available data, thereby minimizing bias from incomplete follow-up measurements.||||0.754
71152359|NCT04672655|141796896|OTHER|||||||0.0406||||||The a priori threshold for statistical significance was \< 0.05.|linear mixed effects models|||A linear mixed effects model (LMM) was used to examine outcomes measured at 3, 6, and 12 months. An unstructured covariance matrix was specified to model within-subject correlations across repeated measurements. To address missing data, the LMM utilized a likelihood-based approach under the missing-at-random (MAR) assumption, which incorporates all available data, thereby minimizing bias from incomplete follow-up measurements.||||0.0406
71152360|NCT04672655|141796897|OTHER|||||||0.9032||||||The a priori threshold for statistical significance was \< 0.05.|linear mixed effects models|||A linear mixed effects model (LMM) was used to examine outcomes measured at 3, 6, and 12 months. An unstructured covariance matrix was specified to model within-subject correlations across repeated measurements. To address missing data, the LMM utilized a likelihood-based approach under the missing-at-random (MAR) assumption, which incorporates all available data, thereby minimizing bias from incomplete follow-up measurements.||||0.9032
71152361|NCT00494676|141796898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.2|||=|0.001|TWO_SIDED|95.0|1.8|21.0|||McNemar||The marginal odds ratio based on discordant pairs was computed.|The analysis used a McNemar test for data combined across both periods of the crossover. We estimated that 70% and 35% of participants would say yes to the real and sham prisms, respectively. For a 2-tailed test, the minimum sample size to detect a 35% difference in yes responses to real and sham prisms was 57 participants, assuming 30% overlap (30% said yes to both pairs of glasses), power of 90% and α of 1%. Assuming an attrition rate of 20%, we planned to enroll 68 participants.||21.0|1.8|= 0.001
71152362|NCT00494676|141796899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_DEVIATION|2.6|=|0.09|TWO_SIDED|95.0|-0.1|1.3|||t-test, 2 sided|||Mobility improvement scores were normally distributed. A paired t-test was used to conduct a within-subjects comparison of the crossover differences in mobility scores between real and sham prism glasses. An alpha level of 5% was used to indicate statistical significance for secondary analyses||1.3|-0.1|= 0.09
71152363|NCT00494676|141796900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_DEVIATION|2.7|=|0.002|TWO_SIDED|95.0|0.7|3.0|||t-test, 2 sided|||||3.0|0.7|= 0.002
71152364|NCT00494676|141796901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|2.1|=|0.21|TWO_SIDED|95.0|-1.2|0.3|||t-test, 2 sided|||||0.3|-1.2|= 0.21
71152365|NCT04603027|141796904|SUPERIORITY||Posterior Mean difference|-5.99|||||TWO_SIDED|95.0|-20.28|7.12||||||||7.12|-20.28|
71152366|NCT04603027|141796904|SUPERIORITY||Posterior Mean difference|-8.35|||||TWO_SIDED|95.0|-22.07|5.04||||||||5.04|-22.07|
71152367|NCT04603027|141796904|SUPERIORITY||Posterior Mean difference|-9.1|||||TWO_SIDED|95.0|-23.22|4.65||||||||4.65|-23.22|
71152368|NCT04603027|141796905|SUPERIORITY||Posterior Mean difference|-2.6|||||TWO_SIDED|95.0|-13.91|9.9||||||||9.90|-13.91|
71152369|NCT04603027|141796905|SUPERIORITY||Posterior Mean difference|-3.33|||||TWO_SIDED|95.0|-15.21|8.52||||||||8.52|-15.21|
71152370|NCT04603027|141796905|SUPERIORITY||Posterior Mean difference|0.11|||||TWO_SIDED|95.0|-12.33|11.53||||||||11.53|-12.33|
71152371|NCT04603027|141796906|SUPERIORITY||Posterior Mean difference|-0.69|||||TWO_SIDED|95.0|-1.88|0.46||||||||0.46|-1.88|
71152372|NCT04603027|141796906|SUPERIORITY||Posterior Mean difference|-0.73|||||TWO_SIDED|95.0|-1.82|0.45||||||||0.45|-1.82|
71152373|NCT04603027|141796906|SUPERIORITY||Posterior Mean difference|-0.81|||||TWO_SIDED|95.0|-2.05|0.33||||||||0.33|-2.05|
71152374|NCT04603027|141796907|SUPERIORITY||Odds Ratio (OR)|2.64|||||TWO_SIDED|95.0|1.01|6.94||||||||6.94|1.01|
71152375|NCT04603027|141796907|SUPERIORITY||Odds Ratio (OR)|2.93|||||TWO_SIDED|95.0|1.17|7.37||||||||7.37|1.17|
71152376|NCT04603027|141796907|SUPERIORITY||Odds Ratio (OR)|1.73|||||TWO_SIDED|95.0|0.63|4.7||||||||4.70|0.63|
71152377|NCT04603027|141796908|SUPERIORITY|||||||0.1|||||||nonparametric survival analysis|Method used was a nonparametric survival analysis for interval censored data||||||0.100
71152378|NCT04603027|141796908|SUPERIORITY|||||||0.034|||||||nonparametric survival analysis|Method used was a nonparametric survival analysis for interval censored data||||||0.034
71152379|NCT04603027|141796908|SUPERIORITY|||||||0.094|||||||nonparametric survival analysis|Method used was a nonparametric survival analysis for interval censored data||||||0.094
71152380|NCT04603027|141796912|SUPERIORITY||Posterior Mean Odds Ratio|2.14|||||TWO_SIDED|95.0|0.45|10.96||||||||10.96|0.45|
71152381|NCT04603027|141796912|SUPERIORITY||Posterior Mean Odds Ratio|2.02|||||TWO_SIDED|95.0|0.42|8.78||||||||8.78|0.42|
71152382|NCT04603027|141796912|SUPERIORITY||Posterior Mean Odds Ratio|2.12|||||TWO_SIDED|95.0|0.46|9.51||||||||9.51|0.46|
71152383|NCT04603027|141796913|SUPERIORITY||||||||||||||||||There were not enough responders to model using GLMM or a Bayesian logistic model, and no treatment difference analysis was conducted.|||
71152384|NCT04603027|141796913|SUPERIORITY||||||||||||||||||There were not enough responders to model using GLMM or a Bayesian logistic model, and no treatment difference analysis was conducted.|||
71152385|NCT04603027|141796913|SUPERIORITY||||||||||||||||||There were not enough responders to model using GLMM or a Bayesian logistic model, and no treatment difference analysis was conducted.|||
71091911|NCT02696798|141690380|SUPERIORITY||LS Mean Difference (Final Values)|5.2147|STANDARD_ERROR_OF_MEAN|1.1149|<|0.001|TWO_SIDED|95.0|3.0204|7.409|||Mixed Models Analysis|||PCS||7.4090|3.0204|<0.001
71091912|NCT02696798|141690380|SUPERIORITY||LS Mean Difference (Final Values)|4.7585|STANDARD_ERROR_OF_MEAN|1.1505|<|0.001|TWO_SIDED|95.0|2.494|7.023|||Mixed Models Analysis|||PCS||7.0230|2.4940|<0.001
71091913|NCT02696798|141690381|SUPERIORITY||LS Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|0.46||0.026|TWO_SIDED|95.0|-1.94|-0.13|||Mixed Models Analysis|||||-0.13|-1.94|0.026
71091914|NCT02696798|141690381|SUPERIORITY||LS Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.477||0.149|TWO_SIDED|95.0|-1.63|0.25|||Mixed Models Analysis|||||0.25|-1.63|0.149
71091915|NCT02696798|141690382|SUPERIORITY||LS Mean Difference (Final Values)|-1.95|STANDARD_ERROR_OF_MEAN|0.512|<|0.001|TWO_SIDED|95.0|-3.0|-0.9|||ANCOVA|||||-0.9|-3.0|<0.001
71091916|NCT02696798|141690382|SUPERIORITY||LS Mean Difference (Final Values)|-2.17|STANDARD_ERROR_OF_MEAN|0.534|<|0.001|TWO_SIDED|95.0|-3.2|-1.1|||ANCOVA|||||-1.1|-3.2|<0.001
71091917|NCT02696798|141690383|SUPERIORITY||LS Mean Difference (Final Values)|-6.29|STANDARD_ERROR_OF_MEAN|1.896||0.001|TWO_SIDED|95.0|-10.0|-2.5|||ANCOVA|||||-2.5|-10.0|0.001
71091918|NCT02696798|141690383|SUPERIORITY||LS Mean Difference (Final Values)|-7.27|STANDARD_ERROR_OF_MEAN|1.978|<|0.001|TWO_SIDED|95.0|-11.2|-3.4|||ANCOVA|||||-3.4|-11.2|<0.001
71091919|NCT02696798|141690384|SUPERIORITY||LS Mean Difference (Final Values)|-20.816|STANDARD_ERROR_OF_MEAN|3.7463|<|0.001|TWO_SIDED|95.0|-28.187|-13.444|||Mixed Models Analysis|||||-13.444|-28.187|<0.001
71091920|NCT02696798|141690384|SUPERIORITY||LS Mean Difference (Final Values)|-17.841|STANDARD_ERROR_OF_MEAN|3.9018|<|0.001|TWO_SIDED|95.0|-25.518|-10.163|||Mixed Models Analysis|||||-10.163|-25.518|<0.001
71091921|NCT02696798|141690385|SUPERIORITY||LS Mean Difference (Final Values)|-0.304|STANDARD_ERROR_OF_MEAN|0.1275||0.018|TWO_SIDED|95.0|-0.555|-0.053|||Mixed Models Analysis|||||-0.053|-0.555|0.018
71091922|NCT02696798|141690385|SUPERIORITY||LS Mean Difference (Final Values)|-0.172|STANDARD_ERROR_OF_MEAN|0.1319||0.194|TWO_SIDED|95.0|-0.431|0.088|||Mixed Models Analysis|||||0.088|-0.431|0.194
71091923|NCT02696798|141690386|SUPERIORITY||LS Mean Difference (Final Values)|1.23|STANDARD_ERROR_OF_MEAN|0.893||0.17|TWO_SIDED|95.0|-0.53|2.99|||Mixed Models Analysis|||||2.99|-0.53|0.170
71091924|NCT02696798|141690386|SUPERIORITY||LS Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.916||0.8|TWO_SIDED|95.0|-1.57|2.04|||Mixed Models Analysis|||||2.04|-1.57|0.800
71091925|NCT02696798|141690387|SUPERIORITY||LS Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.521||0.547|TWO_SIDED|95.0|-1.34|0.71|||Mixed Models Analysis|||||0.71|-1.34|0.547
71091926|NCT02696798|141690387|SUPERIORITY||LS Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.538||0.064|TWO_SIDED|95.0|-2.06|0.06|||Mixed Models Analysis|||||0.06|-2.06|0.064
71091927|NCT02696798|141690388|SUPERIORITY||LS Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.58||0.861|TWO_SIDED|95.0|-1.0|1.3|||Mixed Models Analysis|||||1.3|-1.0|0.861
71091928|NCT02696798|141690388|SUPERIORITY||LS Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.59||0.626|TWO_SIDED|95.0|-1.4|0.9|||Mixed Models Analysis|||||0.9|-1.4|0.626
71091929|NCT02696798|141690389|SUPERIORITY||LS Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.59||0.504|TWO_SIDED|95.0|-1.6|0.8|||Mixed Models Analysis|||||0.8|-1.6|0.504
71091930|NCT02696798|141690389|SUPERIORITY||LS Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.62||0.86|TWO_SIDED|95.0|-1.1|1.3|||Mixed Models Analysis|||||1.3|-1.1|0.860
71091931|NCT02696798|141690390|SUPERIORITY||LS Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|1.03||0.362|TWO_SIDED|95.0|-3.0|1.1|||Mixed Models Analysis|||||1.1|-3.0|0.362
71091932|NCT02696798|141690390|SUPERIORITY||LS Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|1.08||0.303|TWO_SIDED|95.0|-3.3|1.0|||Mixed Models Analysis|||||1.0|-3.3|0.303
71091933|NCT02696798|141690391|SUPERIORITY||LS Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.7||0.813|TWO_SIDED|95.0|-1.5|1.2|||Mixed Models Analysis|||||1.2|-1.5|0.813
71091934|NCT02696798|141690391|SUPERIORITY||LS Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.71||0.41|TWO_SIDED|95.0|-2.0|0.8|||Mixed Models Analysis|||||0.8|-2.0|0.410
71091935|NCT02696798|141690393|SUPERIORITY||LS Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|95.0|-1.9|-0.6|||Mixed Models Analysis|||||-0.6|-1.9|<0.001
71091936|NCT02696798|141690393|SUPERIORITY||LS Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.34||0.005|TWO_SIDED|95.0|-1.6|-0.3|||Mixed Models Analysis|||||-0.3|-1.6|0.005
71091937|NCT02696798|141690394|SUPERIORITY||LS Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.68||0.088|TWO_SIDED|95.0|-2.5|0.2|||Mixed Models Analysis|||||0.2|-2.5|0.088
71091938|NCT02696798|141690394|SUPERIORITY||LS Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.7||0.366|TWO_SIDED|95.0|-2.0|0.7|||Mixed Models Analysis|||||0.7|-2.0|0.366
71091939|NCT02696798|141690395|SUPERIORITY||LS Mean Difference (Final Values)|-11.13|STANDARD_ERROR_OF_MEAN|5.323||0.038|TWO_SIDED|95.0|-21.65|-0.6|||ANCOVA|||Overall Work Impairment Score||-0.60|-21.65|0.038
71091940|NCT02696798|141690395|SUPERIORITY||LS Mean Difference (Final Values)|-13.66|STANDARD_ERROR_OF_MEAN|5.341||0.012|TWO_SIDED|95.0|-24.23|-3.1|||ANCOVA|||Overall Work Impairment Score||-3.10|-24.23|0.012
71091941|NCT02696798|141690395|SUPERIORITY||LS Mean Difference (Final Values)|-6.3|STANDARD_ERROR_OF_MEAN|3.5||0.071|TWO_SIDED|95.0|-13.2|0.5|||ANCOVA|||Percentage of Activity Impairment||0.5|-13.2|0.071
71091942|NCT02696798|141690395|SUPERIORITY||LS Mean Difference (Final Values)|-8.3|STANDARD_ERROR_OF_MEAN|3.65||0.024|TWO_SIDED|95.0|-15.5|-1.1|||ANCOVA|||Percentage of Activity Impairment||-1.1|-15.5|0.024
71091943|NCT03405870|141690424|OTHER|Determined maximum tolerated dose|Value of Maximum Tolerated Dose (g/kg)|1.6|||||TWO_SIDED|||||||||Using sequential dose escalation, participants received 2 doses of 1.0 to 1.6 g/kg of lipid emulsion (Smoflipid 20% lipid emulsion) within 48 hours of enrollment to test the maximum tolerated dose of study drug. The maximum tolerated dose was defined by patients exhibiting specific dose-related toxicities from administration of escalating doses of the study drug. Of 9 patients, adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria.||||
71091944|NCT05172609|141690426|EQUIVALENCE|Margin difference of 1 standard deviation (SD) or higher was considered evidence of non-equivalence comparison||||||0.47|||||||t-test, 2 sided|||T-tests between EBIS and IAU conditions at 12-week follow up for AIM||||.47
71152386|NCT04603027|141796914|SUPERIORITY||Posterior Mean difference|-9.08|||||TWO_SIDED|95.0|-30.22|12.4||||||||12.40|-30.22|
71152387|NCT04603027|141796914|SUPERIORITY||Posterior Mean difference|2.99|||||TWO_SIDED|95.0|-23.41|18.15||||||||18.15|-23.41|
71152388|NCT04603027|141796914|SUPERIORITY||Posterior Mean difference|-17.1|||||TWO_SIDED|95.0|-38.29|3.25||||||||3.25|-38.29|
71152389|NCT04603027|141796915|SUPERIORITY||Posterior Mean difference|-2.66|||||TWO_SIDED|95.0|-6.79|1.52||||||||1.52|-6.79|
71152390|NCT04603027|141796915|SUPERIORITY||Posterior Mean difference|-0.83|||||TWO_SIDED|95.0|-4.7|3.16||||||||3.16|-4.70|
71152391|NCT04603027|141796915|SUPERIORITY||Posterior Mean difference|-3.53|||||TWO_SIDED|95.0|-7.49|0.63||||||||0.63|-7.49|
71152392|NCT04603027|141796916|SUPERIORITY||Posterior Mean difference|-9.08|||||TWO_SIDED|95.0|-30.22|12.4||||||||12.40|-30.22|
71152393|NCT04603027|141796916|SUPERIORITY||Posterior Mean difference|-2.99|||||TWO_SIDED|95.0|-23.41|18.15||||||||18.15|-23.41|
71152394|NCT04603027|141796916|SUPERIORITY||Posterior Mean difference|-17.1|||||TWO_SIDED|95.0|-38.29|3.25||||||||3.25|-38.29|
71152395|NCT04603027|141796917|SUPERIORITY||Posterior Mean difference|-2.66|||||TWO_SIDED|95.0|-6.79|1.52||||||||1.52|-6.79|
71152396|NCT04603027|141796917|SUPERIORITY||Posterior Mean difference|-0.83|||||TWO_SIDED|95.0|-4.7|3.16||||||||3.16|-4.70|
71152397|NCT04603027|141796917|SUPERIORITY||Posterior Mean difference|-3.53|||||TWO_SIDED|95.0|-7.49|0.63||||||||0.63|-7.49|
71152398|NCT04603027|141796918|SUPERIORITY||Posterior Mean difference|2.99|||||TWO_SIDED|95.0|-19.99|28.84||||||||28.84|-19.99|
71152399|NCT04603027|141796918|SUPERIORITY||Posterior Mean difference|-2.49|||||TWO_SIDED|95.0|-26.47|21.55||||||||21.55|-26.47|
71152400|NCT04603027|141796918|SUPERIORITY||Posterior Mean difference|13.36|||||TWO_SIDED|95.0|-12.03|36.92||||||||36.92|-12.03|
71152401|NCT04603027|141796919|SUPERIORITY||Posterior Mean difference|0.62|||||TWO_SIDED|95.0|-1.1|2.3||||||||2.30|-1.10|
71152402|NCT04603027|141796919|SUPERIORITY||Posterior Mean difference|-0.21|||||TWO_SIDED|95.0|-1.96|1.37||||||||1.37|-1.96|
71152403|NCT04603027|141796919|SUPERIORITY||Posterior Mean difference|-0.08|||||TWO_SIDED|95.0|-1.73|1.75||||||||1.75|-1.73|
71152404|NCT04603027|141796920|SUPERIORITY||Posterior Mean difference|13.71|||||TWO_SIDED|95.0|-50.62|73.35||||||||73.35|-50.62|
71152405|NCT04603027|141796920|SUPERIORITY||Posterior Mean difference|73.69|||||TWO_SIDED|95.0|21.69|126.92||||||||126.92|21.69|
71152406|NCT04603027|141796920|SUPERIORITY||Posterior Mean difference|8.41|||||TWO_SIDED|95.0|-44.58|56.81||||||||56.81|-44.58|
71152407|NCT04603027|141796921|SUPERIORITY||Posterior Mean difference|0.62|||||TWO_SIDED|95.0|-1.1|2.3||||||||2.30|-1.10|
71152408|NCT04603027|141796921|SUPERIORITY||Posterior Mean difference|-0.21|||||TWO_SIDED|95.0|-1.96|1.37||||||||1.37|-1.96|
71152409|NCT04603027|141796921|SUPERIORITY||Posterior Mean difference|-0.08|||||TWO_SIDED|95.0|-1.73|1.75||||||||1.75|-1.73|
71152410|NCT02688777|141796925|SUPERIORITY||Hazard Ratio, log|0.6|||||TWO_SIDED|||||||||||||
71152411|NCT02688777|141796926|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.37|TWO_SIDED|||||A priori threshold for significance is p \< 0.05.|t-test, 2 sided|||||||0.37
71152412|NCT02688777|141796927|SUPERIORITY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.02||0.13|TWO_SIDED|||||A priori threshold set for p \< 0.05|t-test, 2 sided|||||||0.13
71152413|NCT02688777|141796928|SUPERIORITY||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|1.0||0.4|TWO_SIDED|||||A priori threshold p \< 0.05 for statistical significance.|t-test, 2 sided|||||||0.40
71152414|NCT02688777|141796929|SUPERIORITY||Mean Difference (Final Values)|5.7|STANDARD_ERROR_OF_MEAN|3.4||0.12|TWO_SIDED||||||t-test, 2 sided|||||||0.12
71152415|NCT02688777|141796930|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|1.1||0.43|TWO_SIDED|||||A priori threshold set at p \< 0.05 for statistical significance.|t-test, 2 sided|||||||0.43
71152416|NCT02688777|141796931|SUPERIORITY||Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|0.8||0.02|TWO_SIDED|||||A prior threshold for significance set at p \< 0.05|t-test, 2 sided|||||||0.02
71152417|NCT02688777|141796932|SUPERIORITY||Mean Difference (Final Values)|13.95|STANDARD_ERROR_OF_MEAN|8.9||0.28|TWO_SIDED||||||t-test, 2 sided|||||||0.28
71152418|NCT02688777|141796933|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.22|TWO_SIDED||||||t-test, 2 sided|||||||0.22
71152419|NCT02688777|141796934|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.10
71152420|NCT02688777|141796935|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
71152421|NCT02688777|141796936|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
71152422|NCT02688777|141796937|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||||||0.28
71152423|NCT01009619|141796948|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared, Corrected|||The frequency or rate of specific events (i.e. acute rejection, cytomegalovirus (CMV) and non-CMV infections) was calculated by determining the number of events per year of study time for each subject, correcting for CMV-mismatch status.||||<0.05
71152424|NCT01009619|141796949|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared, Corrected|||The frequency or rate of specific events (i.e. acute rejection, cytomegalovirus (CMV) and non-CMV infections) was calculated by determining the number of events per year of study time for each subject, correcting for CMV-mismatch status.||||<0.05
71152425|NCT04939415|141796964|SUPERIORITY||ratio of frequencies|0.0||||1|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||1.000
71152426|NCT04939415|141796965|SUPERIORITY||ratio of frequencies|1.023||||1|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||1.000
71152427|NCT04939415|141796967|SUPERIORITY||ratio of frequencies|1.073||||0.488|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||0.488
71152428|NCT04939415|141796968|SUPERIORITY||ratio of frequencies|2.1||||0.488|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||0.488
71152429|NCT04939415|141796970|SUPERIORITY||ratio of frequencies|3.243||||0.231|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||0.231
71152430|NCT04939415|141796971|SUPERIORITY||ratio of frequencies|0.034||||1|TWO_SIDED||||||Chi-squared, Corrected|The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.||||||1.000
71152431|NCT04939415|141796972|OTHER||ratio of frequencies|0.083||||1|TWO_SIDED||||||Chi-squared, Corrected|The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.||||||1.000
71152432|NCT04939415|141796974|SUPERIORITY||ratio of frequencies|1.213||||0.462|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||0.462
71152433|NCT04939415|141796975|SUPERIORITY||ratio of frequencies|0.153||||1|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||1.000
71152434|NCT04939415|141796976|SUPERIORITY||F value|0.185||||0.668|TWO_SIDED||||||Mixed Models Analysis|Group by Day interaction||||||0.668
71152435|NCT04939415|141796977|SUPERIORITY||F value|0.032||||0.86|TWO_SIDED||||||Mixed Models Analysis||Group by Day interaction|||||0.860
71152436|NCT04939415|141796978|SUPERIORITY||F value|0.035||||0.853|TWO_SIDED||||||Mixed Models Analysis||Group by Day interaction|||||0.853
71152437|NCT04939415|141796979|SUPERIORITY||F value|0.0||||0.995|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.995
70969672|NCT02187172|141444916|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.51||0.4608|TWO_SIDED|95.0|-0.65|1.4|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||1.40|-0.65|0.4608
70969673|NCT02187172|141444917|SUPERIORITY||Mean Difference (Final Values)|3320.58|STANDARD_ERROR_OF_MEAN|3414.9||0.337|TWO_SIDED|95.0|-3592.52|10233.67|||Regression, Linear|||Comparison during RCT period||10233.67|-3592.52|0.3370
70969674|NCT02187172|141444917|SUPERIORITY||Mean Difference (Final Values)|6926.25|STANDARD_ERROR_OF_MEAN|2257.84||0.004|TWO_SIDED|95.0|2351.43|11501.07|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||11501.07|2351.43|0.0040
70969675|NCT02187172|141444918|SUPERIORITY||Mean Difference (Final Values)|-68.95|STANDARD_ERROR_OF_MEAN|131.9||0.6042|TWO_SIDED|95.0|-335.97|198.08|||Regression, Linear|||Comparison during RCT period||198.08|-335.97|0.6042
70969676|NCT02187172|141444918|SUPERIORITY||Mean Difference (Final Values)|-7.96|STANDARD_ERROR_OF_MEAN|85.98||0.9267|TWO_SIDED|95.0|-182.18|166.26|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||166.26|-182.18|0.9267
70969677|NCT02187172|141444919|SUPERIORITY||Mean Difference (Final Values)|4.2|STANDARD_ERROR_OF_MEAN|5.18||0.4226|TWO_SIDED|95.0|-6.28|14.68|||Regression, Linear|||Comparison during RCT period||14.68|-6.28|0.4226
70969678|NCT02187172|141444919|SUPERIORITY||Mean Difference (Final Values)|3.41|STANDARD_ERROR_OF_MEAN|3.43||0.327|TWO_SIDED|95.0|-3.54|10.36|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||10.36|-3.54|0.3270
71152438|NCT04939415|141796980|SUPERIORITY||F value|1.27||||0.266|TWO_SIDED||||||Mixed Models Analysis|||||||0.266
71152439|NCT04939415|141796981|SUPERIORITY||F value|4.533||||0.039|TWO_SIDED||||||Mixed Models Analysis||group by day interaction is reported.|||||0.039
71152440|NCT04939415|141796981|SUPERIORITY||F Ratio|13.897|||<|0.001|TWO_SIDED||||||ANOVA|Degrees of freedom: 1,23||day 0 to day 14 for the mQFPD group were examined.||||<0.001
71152441|NCT04939415|141796981|SUPERIORITY||F ratio|0.41||||0.529|TWO_SIDED||||||ANOVA|degrees of freedom: 1,20||day 0 to day 14 for the Placebo Group were examined.||||0.529
71152442|NCT04939415|141796982|SUPERIORITY||ratio of frequencies|0.14||||0.71|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.710
71152443|NCT04939415|141796983|SUPERIORITY||F value|2.855||||0.099|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.099
71152444|NCT04939415|141796984|SUPERIORITY||F value|1.497||||0.228|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.228
71152445|NCT04939415|141796985|SUPERIORITY||F value|2.537||||0.119|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.119
71152446|NCT04939415|141796986|SUPERIORITY||F value|0.219||||0.643|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.643
71152447|NCT04939415|141796987|SUPERIORITY||F value|0.054||||0.817|TWO_SIDED||||||Mixed Models Analysis|||||||0.817
71152448|NCT04939415|141796988|SUPERIORITY||F value|0.315||||0.578|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.578
71152449|NCT04939415|141796989|SUPERIORITY||F value|0.215||||0.643|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||.643
71152450|NCT04939415|141796990|SUPERIORITY||F value|1.987||||0.159|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||.159
71152451|NCT01931566|141796996|OTHER|||||||0.023|||||||Regression, Cox|||||||0.023
71152452|NCT01931566|141796997|SUPERIORITY|||||||0.307|||||||Regression, Cox|||||||0.307
71152453|NCT00611026|141797002|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||"Treatment difference fesoterodine versus (vs) placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the fifth (5th) and ninety-fifth (95th) percentile, respectively).~If normality assumptions were severely violated (proportion of non normal observations \> 5%) a non-parametric analysis was to be conducted using Van Elteren's test stratified by baseline quartile of the diary variable analyzed."||||<0.0001
71152454|NCT00611026|141797002|SUPERIORITY_OR_OTHER|||||||0.0228|TWO_SIDED|||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference tolterodine ER vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0228
71152455|NCT00611026|141797002|SUPERIORITY_OR_OTHER|||||||0.0072|TWO_SIDED|||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference fesoterodine vs tolterodine ER at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0072
71152456|NCT00611026|141797003|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||"Treatment difference fesoterodine vs placebo at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).~If normality assumptions were severely violated (proportion of non normal observations \> 5%) a non-parametric analysis was to be conducted using Van Elteren's test stratified by baseline quartile of the diary variable analyzed."||||0.0020
71152457|NCT00611026|141797003|SUPERIORITY_OR_OTHER|||||||0.0519|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference tolterodine ER vs placebo at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0519
71152458|NCT00611026|141797003|SUPERIORITY_OR_OTHER|||||||0.1503|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference fesoterodine vs tolterodine ER at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.1503
71152459|NCT00611026|141797003|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference fesoterodine vs placebo at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
71152460|NCT00611026|141797003|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference tolterodine ER vs placebo at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0002
71152461|NCT00611026|141797003|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||Van Elteren's|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference fesoterodine vs tolterodine ER at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0130
71152462|NCT00611026|141797003|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference fesoterodine vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
71152463|NCT00611026|141797003|SUPERIORITY_OR_OTHER|||||||0.0021|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference tolterodine ER vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0021
71152464|NCT00611026|141797003|SUPERIORITY_OR_OTHER|||||||0.0525|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference fesoterodine vs tolterodine ER at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0525
71152465|NCT00611026|141797004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0161|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 1.||-0.1|-0.5|0.0161
71152466|NCT00611026|141797004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0944|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 1.||0.0|-0.4|0.0944
71152467|NCT00611026|141797004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3613|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 1.||0.1|-0.3|0.3613
71152468|NCT00611026|141797004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.9|-0.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 4.||-0.4|-0.9|<0.0001
71152469|NCT00611026|141797004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0043|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 4.||-0.1|-0.6|0.0043
71152470|NCT00611026|141797004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0186|TWO_SIDED|95.0|-0.5|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 4.||-0.0|-0.5|0.0186
71152471|NCT00611026|141797004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.9|-0.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 12.||-0.4|-0.9|<0.0001
71152472|NCT00611026|141797004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0407|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 12.||-0.0|-0.6|0.0407
71152473|NCT00611026|141797004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0016|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 12.||-0.1|-0.6|0.0016
71152474|NCT00611026|141797005|SUPERIORITY_OR_OTHER|||||||0.0217|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 1.||||0.0217
71152475|NCT00611026|141797005|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 4.||||<0.0001
71152476|NCT00611026|141797005|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 4.||||0.0020
71152477|NCT00611026|141797005|SUPERIORITY_OR_OTHER|||||||0.0217|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference fesoterodine vs Tolterodine ER at Week 4.||||0.0217
71152478|NCT00611026|141797005|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 12.||||<0.0001
71152479|NCT00611026|141797005|SUPERIORITY_OR_OTHER|||||||0.0421|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 12.||||0.0421
71152480|NCT00611026|141797005|SUPERIORITY_OR_OTHER|||||||0.0023|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference fesoterodine vs Tolterodine ER at Week 12.||||0.0023
71152481|NCT00611026|141797006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.1||0.3823|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 1.||0.1|-0.1|0.3823
71152482|NCT00611026|141797006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.1||0.4802|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 1.||0.1|-0.1|0.4802
71152483|NCT00611026|141797006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.0||0.8355|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 1.||0.1|-0.1|0.8355
71152484|NCT00611026|141797006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.1||0.0286|TWO_SIDED|95.0|-0.12|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 4.||-0.0|-0.12|0.0286
71152485|NCT00611026|141797006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.0794|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 4.||0.0|-0.2|0.0794
71152486|NCT00611026|141797006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.0||0.5906|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 4.||0.1|-0.1|0.5906
71152487|NCT00611026|141797006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.1||0.0134|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 12.||-0.0|-0.3|0.0134
71152488|NCT00611026|141797006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.1||0.1759|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 12.||0.0|-0.2|0.1759
71152489|NCT00611026|141797006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.0||0.1661|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 12.||0.0|-0.2|0.1661
71152490|NCT00611026|141797007|SUPERIORITY_OR_OTHER|||||||0.0021|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 4.||||0.0021
71152491|NCT00611026|141797007|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 12.||||0.0200
71091945|NCT05172609|141690427|EQUIVALENCE|Margin difference of 1 SD or higher was considered evidence of non-equivalence comparison||||||0.88|||||||t-test, 2 sided|||T-tests between EBIS and IAU conditions at 12-week follow up for FIM||||.88
71152492|NCT00611026|141797008|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||"Treatment difference fesoterodine vs placebo at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).~If normality assumptions were severely violated (proportion of non normal observations \> 5%) a non-parametric analysis was to be conducted using Van Elteren's test stratified by baseline quartile of the diary variable analyzed."||||0.0006
71152493|NCT00611026|141797008|SUPERIORITY_OR_OTHER|||||||0.0202|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference Tolterodine ER vs placebo at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0202
71152494|NCT00611026|141797008|SUPERIORITY_OR_OTHER|||||||0.2126|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference fesoterodine vs Tolterodine ER at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.2126
71152495|NCT00611026|141797008|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference fesoterodine vs placebo at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
71091946|NCT05172609|141690428|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing SUDS screening rating at Time 3: two weeks after completing the training||||.46
71152496|NCT00611026|141797008|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference Tolterodine ER vs placebo at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0019
71152497|NCT00611026|141797008|SUPERIORITY_OR_OTHER|||||||0.0148|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference fesoterodine vs Tolterodine ER at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0148
71152498|NCT00611026|141797009|SUPERIORITY_OR_OTHER|||||||0.0012|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 1.||||0.0012
70969679|NCT02187172|141444920|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|1.52||0.7507|TWO_SIDED|95.0|-3.56|2.59|||Regression, Linear|||Comparison during RCT period||2.59|-3.56|0.7507
70969680|NCT02187172|141444920|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.89||0.9348|TWO_SIDED|95.0|-1.88|1.73|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||1.73|-1.88|0.9348
70969681|NCT02187172|141444921|SUPERIORITY||Difference of proportions|0.67||||0.0005|TWO_SIDED|95.0|0.45|0.89|||Chi-squared|||||0.89|0.45|0.0005
70969682|NCT02187172|141444921|OTHER|95% CI of proportion achieving PASI75 at end of study|Proportion|0.72|||||TWO_SIDED|95.0|0.55|0.85||||||||0.85|0.55|
70969683|NCT02187172|141444922|SUPERIORITY||Difference of proportions|0.41||||0.0016|TWO_SIDED|95.0|0.2|0.62|||Chi-squared|||||0.62|0.20|0.0016
70969684|NCT02187172|141444922|OTHER|95% CI of proportion achieving PASI90 at end of study|Proportion|0.49|||||TWO_SIDED|95.0|0.32|0.65||||||||0.65|0.32|
70969685|NCT02187172|141444923|SUPERIORITY||Difference of proportions|0.53||||0.0005|TWO_SIDED|95.0|0.29|0.78|||Chi-squared|||Comparison during RCT period for binary Physician Global Assessment||0.78|0.29|0.0005
70969686|NCT02187172|141444923|OTHER|95% CI of proportion achieving PGA clear/almost clear at end of study|Proportion|0.46|||||TWO_SIDED|95.0|0.3|0.63||||||||0.63|0.30|
70969687|NCT02187172|141444924|SUPERIORITY||Mean Difference (Final Values)|8.32|STANDARD_ERROR_OF_MEAN|6.3||0.1944|TWO_SIDED|95.0|-4.42|21.06|||Regression, Linear|||||21.06|-4.42|0.1944
70969688|NCT02187172|141444924|SUPERIORITY||Mean Difference (Final Values)|-12.33|STANDARD_ERROR_OF_MEAN|3.5||0.0011|TWO_SIDED|95.0|-19.4|-5.25|||Regression, Linear|||||-5.25|-19.40|0.0011
70969689|NCT02187172|141444925|SUPERIORITY||Mean Difference (Final Values)|-779.59|STANDARD_ERROR_OF_MEAN|1049.99||0.4628|TWO_SIDED|95.0|-2911.19|1352.01|||Regression, Linear|||||1352.01|-2911.19|0.4628
70969690|NCT02187172|141444925|SUPERIORITY||Mean Difference (Final Values)|-910.84|STANDARD_ERROR_OF_MEAN|729.96||0.2209|TWO_SIDED|95.0|-2395.95|574.27|||Regression, Linear|||||574.27|-2395.95|0.2209
70969691|NCT04673292|141444926|EQUIVALENCE|The fixed site SOC testing study arm was the standard of care and reference group. The null hypothesis was that there is not a statistically significant difference in the proportion of participants who complete PCR COVID-19 testing within 30 days of randomization when comparing community-based testing to the fixed site SOC testing.|Prevalence Ratio|1.04||||0.67|TWO_SIDED|95.0|0.86|1.27|||Poisson Regression|Adjusted poisson regression was performed using Study Arm as a nominal variable in the model with the Fixed Site SOC Testing as the reference group.|||Models were adjusted for employment.|1.27|0.86|0.67
70969692|NCT04673292|141444926|EQUIVALENCE|The fixed site SOC testing study arm was the standard of care and reference group. The null hypothesis was that there is not a statistically significant difference in the proportion of participants who complete PCR COVID-19 testing within 30 days of randomization when comparing self-collected testing to the fixed site SOC testing.|Prevalence Ratio|1.08||||0.43|TWO_SIDED|95.0|0.89|1.31|||Poisson Regression|Adjusted poisson regression was performed using Study Arm as a nominal variable in the model with the Fixed Site SOC Testing as the reference group.|||Models were adjusted for employment.|1.31|0.89|0.43
71152499|NCT00611026|141797009|SUPERIORITY_OR_OTHER|||||||0.0205|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 1.||||0.0205
71152500|NCT00611026|141797009|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 4.||||<0.0001
70969693|NCT04673292|141444927|EQUIVALENCE|Testing for equivalence in the difference in time from randomization to completion of SARS-CoV-2 PCR testing when comparing the community-based testing to fixed site SOC testing. Alpha threshold of 0.05.|Time Ratio|0.87||||0.14|TWO_SIDED|95.0|0.73|1.05||aprior significance threshold: p-value\<0.05|Accelerated Failure Time|Study Arm included as a nominal (dummy) variable in accelerated failure time models. Models adjusted for employment.||Times were censored at 30 days.|Models adjusted for employment|1.05|0.73|0.14
70969694|NCT04673292|141444927|EQUIVALENCE|Testing for equivalence in the difference in time from randomization to completion of SARS-CoV-2 PCR testing when comparing the self-collected testing arm to the fixed site SOC testing Alpha threshold of 0.05.|Time Ratio|0.86||||0.09|TWO_SIDED|95.0|0.71|1.03||aprior significance threshold: p-value\<0.05|Accelerated Failure Time|Study Arm included as a nominal (dummy) variable in accelerated failure time models. Models adjusted for employment.||Times were censored at 30 days.|Models adjusted for employment|1.03|0.71|0.09
70969695|NCT04673292|141444928|EQUIVALENCE|Null hypothesis: There is no significant difference in time from completion of SARS-CoV-2 test to receipt of SARS-CoV-2 test results when comparing the community-based testing to fixed site SOC testing.|Time Ratio|0.96||||0.56|TWO_SIDED|95.0|0.83|1.1||aprior threshold for significance: p\<0.05|Accelerated Failure Time|Study arm included as a nominal (dummy) variable in accelerated failure time models. Models adjusted for employment.||Times were censored at 10 days.|Models adjusted for employment|1.10|0.83|0.56
70969696|NCT04673292|141444928|EQUIVALENCE|Null hypothesis: There is no significant difference in time from completion of SARS-CoV-2 test to receipt of SARS-CoV-2 test results when comparing the self-collected testing arm to the fixed site SOC testing.|Time Ratio|0.93||||0.32|TWO_SIDED|95.0|0.81|1.07||aprior significance threshold: p-value\<0.05|Accelerated Failure Time|Study Arm included as a nominal (dummy) variable in accelerated failure time models. Models adjusted for employment.||Times were censored at 10 days.|Models adjusted for employment|1.07|0.81|0.32
70969697|NCT03045861|141444978|OTHER||Emax|-1.822|||||TWO_SIDED|95.0|-2.333|1.31||||||||1.310|-2.333|
71152501|NCT00611026|141797009|SUPERIORITY_OR_OTHER|||||||0.0038|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 4.||||0.0038
71152502|NCT00611026|141797009|SUPERIORITY_OR_OTHER|||||||0.0219|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||||0.0219
71152503|NCT00611026|141797009|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 12.||||0.0001
71152504|NCT00611026|141797009|SUPERIORITY_OR_OTHER|||||||0.0805|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 12.||||0.0805
71152505|NCT00611026|141797009|SUPERIORITY_OR_OTHER|||||||0.0093|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||||0.0093
71152506|NCT00611026|141797010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0374|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 1.||-0.0|-0.7|0.0374
71152507|NCT00611026|141797010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3161|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 1.||0.2|-0.5|0.3161
71091947|NCT05172609|141690428|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing SUDS screening rating at Time 4: 12 weeks after completing the training||||.40
71091948|NCT05172609|141690428|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing SUDS planning rating at Time 3: two weeks after completing the training||||.56
71152508|NCT00611026|141797010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1817|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 1.||0.1|-0.5|0.1817
71152509|NCT00611026|141797010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.6|-0.8|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 4.||-0.8|-1.6|<0.0001
71152510|NCT00611026|141797010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0054|TWO_SIDED|95.0|-1.0|-0.2|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 4.||-0.2|-1.0|0.0054
71152511|NCT00611026|141797010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0005|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||-0.3|-0.9|0.0005
71152512|NCT00611026|141797010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.5|-0.6|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 12.||-0.6|-1.5|<0.0001
71152513|NCT00611026|141797010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1467|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 12.||0.1|-0.7|0.1467
71152514|NCT00611026|141797010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.1|-0.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||-0.4|-1.1|<0.0001
71152515|NCT00611026|141797011|SUPERIORITY_OR_OTHER|||||||0.0828|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 1.||||0.0828
71152516|NCT00611026|141797011|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 4.||||<0.0001
71152517|NCT00611026|141797011|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 4.||||0.0008
71152518|NCT00611026|141797011|SUPERIORITY_OR_OTHER|||||||0.0022|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||||0.0022
71152519|NCT00611026|141797011|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 12.||||<0.0001
71152520|NCT00611026|141797011|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||||0.0008
71152521|NCT00611026|141797012|SUPERIORITY_OR_OTHER|||||||0.0576|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||"Treatment difference fesoterodine vs placebo at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).~If normality assumptions were severely violated (proportion of non normal observations \> 5%) a non-parametric analysis was to be conducted using Van Elteren's test stratified by baseline quartile of the diary variable analyzed."||||0.0576
71152522|NCT00611026|141797012|SUPERIORITY_OR_OTHER|||||||0.223|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference Tolterodine ER vs placebo at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||0.2230
71152523|NCT00611026|141797012|SUPERIORITY_OR_OTHER|||||||0.3555|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference fesoterodine vs Tolterodine ER at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||0.3555
71152524|NCT00611026|141797012|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference fesoterodine vs placebo at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||<0.0001
71152525|NCT00611026|141797012|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference Tolterodine ER vs placebo at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||0.0009
71152526|NCT00611026|141797012|SUPERIORITY_OR_OTHER|||||||0.0071|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference fesoterodine vs Tolterodine ER at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||0.0071
71152527|NCT00611026|141797012|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference fesoterodine vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||<0.0001
71091949|NCT05172609|141690428|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing SUDS planning rating at Time 4: 12 weeks after completing the training||||.68
71091950|NCT05172609|141690428|SUPERIORITY|||||||0.87|||||||ANCOVA|||Repeated measures analysis of covariance (ANCOVA), controlling for organization: SUDS screening at timepoints 1, 3, and 4||||.87
71152528|NCT00611026|141797012|SUPERIORITY_OR_OTHER|||||||0.1764|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference Tolterodine ER vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||0.1764
71152529|NCT00611026|141797012|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference fesoterodine vs Tolterodine ER at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||0.0001
71152530|NCT00611026|141797013|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 4.||||<0.0001
71152531|NCT00611026|141797013|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 4.||||0.0003
71152532|NCT00611026|141797013|SUPERIORITY_OR_OTHER|||||||0.0302|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||||0.0302
71152533|NCT00611026|141797013|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 12.||||<0.0001
71152534|NCT00611026|141797013|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||||0.0007
71152535|NCT00611026|141797014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.0701|TWO_SIDED|95.0|-0.1|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 1.||0.0|-0.1|0.0701
71152536|NCT00611026|141797014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.4823|TWO_SIDED|95.0|-0.1|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 1.||0.0|-0.1|0.4823
71152537|NCT00611026|141797014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.1702|TWO_SIDED|95.0|-0.1|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 1.||0.0|-0.1|0.1702
71152538|NCT00611026|141797014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|TWO_SIDED|95.0|-0.3|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 4.||-0.1|-0.3|<0.0001
71152539|NCT00611026|141797014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.0059|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 4.||-0.0|-0.2|0.0059
71152540|NCT00611026|141797014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.0014|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||-0.0|-0.2|0.0014
71152541|NCT00611026|141797014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|TWO_SIDED|95.0|-0.3|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 12.||-0.1|-0.3|<0.0001
71152542|NCT00611026|141797014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.311|TWO_SIDED|95.0|-0.1|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 12.||0.0|-0.1|0.3110
70969698|NCT03045861|141444978|OTHER||ED50|1020.755|||||TWO_SIDED|95.0|100.786|1940.724||||||||1940.724|100.786|
71152543|NCT00611026|141797014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.0004|TWO_SIDED|95.0|-0.2|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||-0.1|-0.2|0.0004
70969699|NCT03045861|141444978|OTHER||s2e|0.2|||||TWO_SIDED|95.0|0.095|0.306||||||||0.306|0.095|
70969700|NCT03045861|141444979|OTHER||Emax|-1.801|||||TWO_SIDED|95.0|-2.319|-1.283||||||||-1.283|-2.319|
70969701|NCT03045861|141444979|OTHER||ED50|55.572|||||TWO_SIDED|95.0|3.565|107.579||||||||107.579|3.565|
70969702|NCT03045861|141444979|OTHER||s2e|0.206|||||TWO_SIDED|95.0|0.097|0.314||||||||0.314|0.097|
70969703|NCT03045861|141444980|OTHER||Emax|-1.846|||||TWO_SIDED|95.0|-2.352|-1.34||||||||-1.340|-2.352|
70969704|NCT03045861|141444980|OTHER||ED50|32.415|||||TWO_SIDED|95.0|4.687|60.143||||||||60.143|4.687|
70969705|NCT03045861|141444980|OTHER||s2e|0.2|||||TWO_SIDED|95.0|0.094|0.305||||||||0.305|0.094|
70969706|NCT01040351|141445044|NON_INFERIORITY_OR_EQUIVALENCE|. The aggregate result of 6 studies reporting the pregnancy rate of patients with ultrasound visible hydrosalpinx revealed that clinical pregnancy rate among the patients with ultrasound-visible hydrosalpinges was 12.6%. We assumed that the aspiration of hydrosalpinx could restore clinical pregnancy rate to that expected for patients with tubal factor of infertility but without hydrosalpinges (about 36.5% in our hospital)|Odds Ratio (OR)|3.02||||0.023|TWO_SIDED|95.0|1.13|8.0|||Chi-squared|||||8.0|1.13|0.023
71152544|NCT00611026|141797015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.6||0.0136|TWO_SIDED|95.0|-2.7|-0.3|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 1.||-0.3|-2.7|0.0136
70969707|NCT02605187|141445051|SUPERIORITY|||||||0.882||||||Final parameter estimates would be considered significant at P \< 0.05.|ANOVA|||Comparison of pain at rest 24 hours after delivery. Null Hypothesis: all the means are the same.||||0.882
70969708|NCT02605187|141445051|SUPERIORITY|||||||0.565||||||Final parameter estimates would be considered significant at P \< 0.05.|ANOVA|||Comparison of pain at movement 24 hours after delivery. Null Hypothesis: all the means are the same.||||0.565
70969709|NCT02605187|141445051|SUPERIORITY|||||||0.022||||||Final parameter estimates would be considered significant at P \< 0.05.|ANOVA|||Comparison of pain at rest 48 hours after delivery. Null Hypothesis: all the means are the same.||||0.022
71091951|NCT05172609|141690428|SUPERIORITY|||||||0.43|||||||ANCOVA|||repeated measures analysis of covariance (ANCOVA), controlling for organization: SUDS planning at timepoints 1, 3, and 4||||.43
70969710|NCT02605187|141445051|SUPERIORITY|||||||0.14||||||Final parameter estimates would be considered significant at P \< 0.05.|ANOVA|||Comparison of pain at movement 48 hours after delivery. Null Hypothesis: all the means are the same.||||0.140
71091952|NCT05172609|141690429|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing screening self-efficacy rating at Time 3: two weeks after completing the training||||.59
70969711|NCT02605187|141445052|SUPERIORITY|||||||0.311||||||Final parameter estimates would be considered significant at P \< 0.05.|Fisher Exact|||Comparison of opioid use 0-24 hours after delivery.||||0.311
70969712|NCT02605187|141445052|SUPERIORITY|||||||0.008||||||Final parameter estimates would be considered significant at P \< 0.05.|Fisher Exact|||Comparison of opioid use 24-48 hours after delivery.||||0.008
70969713|NCT02605187|141445053|SUPERIORITY|||||||0.092|||||||Fisher Exact|||Comparison of presence of pruritus 0-24 hours after delivery.||||0.092
70969714|NCT02605187|141445053|SUPERIORITY|||||||0.269|||||||Fisher Exact|||Comparison of presence of pruritus 24-48 hours after delivery.||||0.269
70969715|NCT02605187|141445054|SUPERIORITY|||||||0.006|||||||ANOVA|||Comparison of pruritus score 24 hours after delivery. Null Hypothesis: all means are equal||||0.006
70969716|NCT02605187|141445054|SUPERIORITY|||||||0.296|||||||ANOVA|||Comparison of pruritus score 48 hours after delivery. Null Hypothesis: all means are equal||||0.296
70969717|NCT02605187|141445055|SUPERIORITY|||||||0.759|||||||Fisher Exact|||Comparison of participants who need medical treatment of pruritus 0-24 hours after delivery.||||0.759
70969718|NCT02605187|141445055|SUPERIORITY|||||||0.761|||||||Fisher Exact|||Comparison of participants who need medical treatment of pruritus 24-48 hours after delivery.||||0.761
70969719|NCT02605187|141445056|SUPERIORITY|||||||0.281|||||||Chi-squared|||||||0.281
70969720|NCT02605187|141445057|SUPERIORITY|||||||0.786|||||||ANOVA|||Comparison of nausea score 24 hours after delivery. Null Hypothesis: all means are equal||||0.786
70969721|NCT02605187|141445057|SUPERIORITY|||||||0.985|||||||ANOVA|||Comparison of nausea score at 48 hours after delivery. Null Hypothesis: all means are equal||||0.985
70969722|NCT02605187|141445058|SUPERIORITY|||||||0.057|||||||Chi-squared|||Comparison of participants who need nausea treatment from 0-24 hours after delivery.||||0.057
70969723|NCT02605187|141445058|SUPERIORITY|||||||0.246|||||||Fisher Exact|||Comparison of participants who need nausea treatment from 24-48 hours after delivery.||||0.246
70969724|NCT02605187|141445059|SUPERIORITY|||||||0.226|||||||ANOVA|||Comparison of average number of vomiting episodes 0-24 hours after delivery. Null Hypothesis: all means are equal||||0.226
70969725|NCT02605187|141445060|SUPERIORITY|||||||0.036|||||||ANOVA|||||||0.036
70969726|NCT02605187|141445061|SUPERIORITY|||||||0.019|||||||ANOVA|||Comparison of satisfaction with pain medication 24 hours after delivery.||||0.019
70969727|NCT02605187|141445061|SUPERIORITY|||||||0.873|||||||ANOVA|||Comparison of satisfaction with pain medication 48 hours after delivery.||||0.873
70969728|NCT05433571|141445062|SUPERIORITY|Superiority was tested for Senofilcon A (C3) Multifocal Toric lens with UV/HEV filter (Low DC) and concluded if the lower limit of a 95% confidence interval was above 0.80|Mean Population Estimate|0.917|STANDARD_ERROR_OF_MEAN|0.0194|||TWO_SIDED|95.0|0.878|0.955|||Bootstrapping Methods|bias adjusted confidence intervals||||0.955|0.878|
71091953|NCT05172609|141690429|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing screening self-efficacy rating at Time 4: 12 weeks after completing the training||||.59
71152545|NCT00611026|141797015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.6||0.1918|TWO_SIDED|95.0|-2.0|0.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 1.||0.4|-2.0|0.1918
71152546|NCT00611026|141797015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.5||0.1505|TWO_SIDED|95.0|-1.7|0.3|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 1.||0.3|-1.7|0.1505
71152547|NCT00611026|141797015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|TWO_SIDED|95.0|-5.2|-2.6|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 4.||-2.6|-5.2|<0.0001
71152548|NCT00611026|141797015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.7||0.0034|TWO_SIDED|95.0|-3.3|-0.7|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 4.||-0.7|-3.3|0.0034
71152549|NCT00611026|141797015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.5||0.0006|TWO_SIDED|95.0|-3.0|-0.8|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||-0.8|-3.0|0.0006
71152550|NCT00611026|141797015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|TWO_SIDED|95.0|-5.0|-2.3|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 12.||-2.3|-5.0|<0.0001
71152551|NCT00611026|141797015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.7||0.0859|TWO_SIDED|95.0|-2.5|0.2|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 12.||0.2|-2.5|0.0859
71152552|NCT00611026|141797015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|-3.6|-1.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||-1.4|-3.6|<0.0001
71152553|NCT00611026|141797016|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs placebo at Week 1.||||0.0008
71152554|NCT00611026|141797016|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for Tolterodine ER vs placebo at Week 1.||||0.0024
70969729|NCT05433571|141445062|SUPERIORITY|Superiority was tested for Senofilcon A (C3) Multifocal Toric lens with UV/HEV filter (High DC) and concluded if the lower limit of a 95% confidence interval was above 0.80|Mean Population Estimate|0.887|STANDARD_ERROR_OF_MEAN|0.0219|||TWO_SIDED|95.0|0.845|0.93|||Bootstrapping Methods|bias adjusted confidence intervals||||0.930|0.845|
71152555|NCT00611026|141797016|SUPERIORITY_OR_OTHER|||||||0.6514|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs Tolterodine ER at Week 1.||||0.6514
71152556|NCT00611026|141797016|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs placebo at Week 4.||||<0.0001
71152557|NCT00611026|141797016|SUPERIORITY_OR_OTHER|||||||0.0063|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for Tolterodine ER vs placebo at Week 4.||||0.0063
71152558|NCT00611026|141797016|SUPERIORITY_OR_OTHER|||||||0.0494|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs Tolterodine ER at Week 4.||||0.0494
71152559|NCT00611026|141797016|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs placebo at Week 12.||||0.0003
71152560|NCT00611026|141797016|SUPERIORITY_OR_OTHER|||||||0.0991|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for Tolterodine ER vs placebo at Week 12.||||0.0991
71152561|NCT00611026|141797016|SUPERIORITY_OR_OTHER|||||||0.0169|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs Tolterodine ER at Week 12.||||0.0169
71152562|NCT00611026|141797017|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 1.||||0.0009
71152563|NCT00611026|141797017|SUPERIORITY_OR_OTHER|||||||0.0279|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 1.||||0.0279
70969730|NCT01918007|141445066|SUPERIORITY||Odds Ratio (OR)|1.3||||0.54|TWO_SIDED|95.0|0.5|3.3|||Chi-squared|||||3.3|0.5|0.54
71152564|NCT00611026|141797017|SUPERIORITY_OR_OTHER|||||||0.2817|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs Fesoterodine at Week 1.||||0.2817
71152565|NCT00611026|141797017|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 4.||||<0.0001
71152566|NCT00611026|141797017|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 4.||||0.0001
71152567|NCT00611026|141797017|SUPERIORITY_OR_OTHER|||||||0.0177|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||||0.0177
71152568|NCT00611026|141797017|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 12.||||<0.0001
71152569|NCT00611026|141797017|SUPERIORITY_OR_OTHER|||||||0.0107|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 12.||||0.0107
71152570|NCT00611026|141797017|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||||0.0005
71152571|NCT00611026|141797018|SUPERIORITY_OR_OTHER|||||||0.0011|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 1.||||0.0011
71152572|NCT00611026|141797018|SUPERIORITY_OR_OTHER|||||||0.0072|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 1.||||0.0072
71152573|NCT00611026|141797018|SUPERIORITY_OR_OTHER|||||||0.3713|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs Tolterodine ER at Week 1.||||0.3713
71152574|NCT00611026|141797018|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 4.||||0.0002
71152575|NCT00611026|141797018|SUPERIORITY_OR_OTHER|||||||0.1485|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 4.||||0.1485
71152576|NCT00611026|141797018|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs Tolterodine ER at Week 4.||||0.0040
71152577|NCT00611026|141797018|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 12.||||<0.0001
71152578|NCT00611026|141797018|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 12.||||0.0060
71152579|NCT00611026|141797018|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs Tolterodine ER at Week 12.||||0.0016
71152580|NCT00611026|141797019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.1|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|-9.5|-4.7|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 12.||-4.7|-9.5|<0.0001
71152581|NCT00611026|141797019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|1.2||0.0458|TWO_SIDED|95.0|-4.8|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 12.||-0.0|-4.8|0.0458
71152582|NCT00611026|141797019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|-6.6|-2.7|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||-2.7|-6.6|<0.0001
71152583|NCT00611026|141797020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.6|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|3.4|7.9|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL scale score total.||7.9|3.4|<0.0001
71152584|NCT00611026|141797020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|1.1||0.0429|TWO_SIDED|95.0|0.1|4.6|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs Placebo: HRQL scale score total.||4.6|0.1|0.0429
71152585|NCT00611026|141797020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|0.9||0.0003|TWO_SIDED|95.0|1.5|5.2|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER: HRQL scale score total.||5.2|1.5|0.0003
71152586|NCT00611026|141797020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|1.3|<|0.0001|TWO_SIDED|95.0|4.0|9.2|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo: HRQL concern domain.||9.2|4.0|<0.0001
71152587|NCT00611026|141797020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|1.3||0.0795|TWO_SIDED|95.0|-0.3|4.9|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Placebo vs Tolterodine ER: HRQL concern domain.||4.9|-0.3|0.0795
71152588|NCT00611026|141797020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|2.1|6.3|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER: HRQL concern domain.||6.3|2.1|<0.0001
70969731|NCT01918007|141445067|SUPERIORITY||Odds Ratio (OR)|14.0|||<|0.001|TWO_SIDED|95.0|2.9|68.4|||Chi-squared|||||68.4|2.9|<0.001
70969732|NCT01918007|141445068|SUPERIORITY||Mean Difference (Net)|-0.31|||<|0.001|TWO_SIDED|95.0|-0.35|-0.27|||t-test, 2 sided|||||-0.27|-0.35|<0.001
70969733|NCT01918007|141445069|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70969734|NCT01918007|141445070|SUPERIORITY||Mean Difference (Net)|-2.76|||<|0.001|TWO_SIDED|95.0|-3.63|-1.9|||t-test, 2 sided|||||-1.90|-3.63|<0.001
70969735|NCT01918007|141445071|SUPERIORITY||Risk Ratio (RR)|1.16||||0.553|TWO_SIDED|95.0|0.71|1.89|||Chi-squared|||||1.89|0.71|0.553
70969736|NCT01918007|141445072|SUPERIORITY||Risk Ratio (RR)|1.79||||0.057|TWO_SIDED|95.0|0.98|3.27|||Chi-squared|||||3.27|0.98|0.057
70969737|NCT01918007|141445073|SUPERIORITY||Risk Ratio (RR)|2.29||||0.084|TWO_SIDED|95.0|0.84|6.25|||Chi-squared|||||6.25|0.84|0.084
70969738|NCT01918007|141445074|SUPERIORITY|||||||0.547|||||||Wilcoxon (Mann-Whitney)|||||||0.547
71091954|NCT05172609|141690429|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing intervening self-efficacy rating at Time 3: two weeks after completing the training||||.25
71091955|NCT05172609|141690429|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing intervening self-efficacy rating at Time 4: 12 weeks after completing the training||||.35
71152589|NCT00611026|141797020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|STANDARD_ERROR_OF_MEAN|1.4|<|0.0001|TWO_SIDED|95.0|4.3|9.6|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL coping domain.||9.6|4.3|<0.0001
71152590|NCT00611026|141797020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|1.3||0.0229|TWO_SIDED|95.0|0.4|5.7|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs placebo: HRQL coping domain.||5.7|0.4|0.0229
70969739|NCT01918007|141445075|SUPERIORITY|||||||0.062|||||||Wilcoxon (Mann-Whitney)|||||||0.062
70969740|NCT01918007|141445076|SUPERIORITY|||||||0.208|||||||Wilcoxon (Mann-Whitney)|||||||0.208
70969741|NCT01918007|141445077|SUPERIORITY|||||||0.585|||||||Wilcoxon (Mann-Whitney)|||||||0.585
70969742|NCT01918007|141445078|SUPERIORITY|||||||0.074|||||||Wilcoxon (Mann-Whitney)|||||||0.074
70969743|NCT01732796|141445083|SUPERIORITY_OR_OTHER||Adjusted response rate|81.4|||<|0.0001|TWO_SIDED|95.0|76.6|86.2|||Stratified one sample z-test||Adjusted response rate will tested against 71%. It is calculated as a weighted average (non-cirrhotic: 89% times response rate+ cirrhotic: 11% times response rate), 11% is the highest rate of cirrhotic from historical trials with approved DAA+PegIFN|The proportion of patients achieving SVR12 was compared to an acceptable minimum SVR rate achieved with an approved direct acting anti-viral (DAA) in combination with pegylated interferon-alfa (PegIFN) from historical data. The acceptable minimum SVR rate was 71% (reference for PegIFN-eligible).||86.2|76.6|<0.0001
70969744|NCT01732796|141445083|SUPERIORITY_OR_OTHER||Adjusted response rate|71.7||||0.3989|TWO_SIDED|95.0|66.1|77.4|||Stratified one sample z-test||Adjusted response rate will tested against 71%. It is calculated as a weighted average (non-cirrhotic: 89% times response rate+ cirrhotic: 11% times response rate), 11% is the highest rate of cirrhotic from historical trials with approved DAA+PegIFN|The proportion of patients achieving SVR12 was compared to an acceptable minimum SVR rate achieved with an approved direct acting anti-viral (DAA) in combination with pegylated interferon-alfa (PegIFN) from historical data. The acceptable minimum SVR rate was 71% (reference for PegIFN-eligible).||77.4|66.1|0.3989
70969745|NCT01732796|141445084|SUPERIORITY_OR_OTHER||Koch's method with continuity correction|10.8||||0.004|TWO_SIDED|95.0|2.8|18.8|||z-test|based on two sample z-test with continuity correction for variance.||||18.8|2.8|0.0040
70969746|NCT01732796|141445085|SUPERIORITY_OR_OTHER||Koch's method with continuity correction|6.0||||0.0575|TWO_SIDED|95.0|-1.5|13.5|||z-test|based on two sample z-test with continuity correction for variance.||Category: Percentage of patient with response||13.5|-1.5|0.0575
70969747|NCT01732796|141445086|SUPERIORITY_OR_OTHER||Koch's method with continuity correction|9.9||||0.0089|TWO_SIDED|95.0|1.7|18.1|||z-test|based on two sample z-test with continuity correction for variance.||Category: Percentage of patient with response||18.1|1.7|0.0089
71091956|NCT05172609|141690429|SUPERIORITY|||||||0.88|||||||ANCOVA|||repeated measures analysis of covariance (ANCOVA), controlling for organization: Self-efficacy screening at timepoints 1, 3, and 4||||.88
71091957|NCT05172609|141690429|SUPERIORITY|||||||0.71|||||||ANCOVA|||repeated measures analysis of covariance (ANCOVA), controlling for organization: Self-efficacy intervening at timepoints 1, 3, and 4||||.71
70969748|NCT00530270|141445092|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||A two-sided alpha of 0.05 was used. No multiple comparison adjustments were made.|Mixed Models Analysis|||The null hypothesis of no difference in the log duration of signs and symptoms or hospitalization between the two treatment groups was tested using an F test from a generalized mixed model with fixed effects for treatment group, age group and ACS severity. Please note that the study was stopped prematurely so only 11 of the 112 originally planned were included in the analysis.||||0.127
70969749|NCT00530270|141445093|SUPERIORITY_OR_OTHER|||||||0.801||||||A two-sided alpha of 0.05 was used. No multiple comparison adjustments were made.|Mixed Models Analysis|||The null hypothesis of no difference in the log duration of signs and symptoms or hospitalization between the two treatment groups was tested using an F test from a generalized mixed model with fixed effects for treatment group, age group and ACS severity. Please note that the study was stopped prematurely so only 11 of the 112 originally planned were included in the analysis.||||0.801
70969750|NCT00530270|141445094|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||A two-sided alpha of 0.05 was used. No multiple comparison adjustments were made.|Mixed Models Analysis|Different error variance estimates were allowed for the two treatment groups.||The null hypothesis of no difference in the log duration of signs and symptoms or hospitalization between the two treatment groups was tested using an F test from a generalized mixed model with fixed effects for treatment group, age group and ACS severity. Please note that the study was stopped prematurely so only 11 of the 112 originally planned were included in the analysis.||||0.02
71152591|NCT00611026|141797020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|STANDARD_ERROR_OF_MEAN|1.1||0.0004|TWO_SIDED|95.0|1.7|6.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER: HRQL coping domain.||6.0|1.7|0.0004
71152592|NCT00611026|141797020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5|STANDARD_ERROR_OF_MEAN|1.2||0.0003|TWO_SIDED|95.0|2.0|6.9|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL sleep domain.||6.9|2.0|0.0003
71152593|NCT00611026|141797020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|1.2||0.0923|TWO_SIDED|95.0|-0.3|4.5|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs placebo: HRQL sleep domain.||4.5|-0.3|0.0923
71152594|NCT00611026|141797020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|1.0||0.018|TWO_SIDED|95.0|0.4|4.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs Fesoterodine: HRQL sleep domain.||4.4|0.4|0.0180
71152595|NCT00611026|141797020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|1.0||0.0011|TWO_SIDED|95.0|1.3|5.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL social interaction domain.||5.1|1.3|0.0011
71152596|NCT00611026|141797020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.0||0.2208|TWO_SIDED|95.0|-0.7|3.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs placebo: HRQL social interaction domain.||3.1|-0.7|0.2208
71152597|NCT00611026|141797020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.8||0.0117|TWO_SIDED|95.0|0.4|3.5|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs Fesoterodine: HRQL social interaction domain.||3.5|0.4|0.0117
71152598|NCT05019521|141797022|SUPERIORITY||Least square (LS) mean difference|0.058|STANDARD_ERROR_OF_MEAN|0.0413||0.9205|TWO_SIDED|90.0|-0.01|0.126|||Mixed Models Analysis|||||0.126|-0.010|0.9205
71152599|NCT05019521|141797022|SUPERIORITY||LS mean difference|-0.016|STANDARD_ERROR_OF_MEAN|0.0425||0.9205|TWO_SIDED|90.0|-0.086|0.055|||Mixed Models Analysis|||||0.055|-0.086|0.9205
71152600|NCT05019521|141797022|SUPERIORITY||LS mean difference|0.037|STANDARD_ERROR_OF_MEAN|0.0422||0.9205|TWO_SIDED|90.0|-0.033|0.106|||Mixed Models Analysis|||||0.106|-0.033|0.9205
70969751|NCT00530270|141445095|SUPERIORITY_OR_OTHER|||||||0.876||95.0||||A two-sided alpha of 0.05 was used. No multiple comparison adjustments were made.|Mixed Models Analysis|Different error variance estimates were allowed for the two treatment groups.||The null hypothesis of no difference in the log duration of signs and symptoms or hospitalization between the two treatment groups was tested using an F test from a generalized mixed model with fixed effects for treatment group, age group and ACS severity. Please note that the study was stopped prematurely so only 11 of the 112 originally planned were included in the analysis.||||0.876
71152601|NCT04625101|141797073|SUPERIORITY|||||||0.4326|||||||ANCOVA|||||||0.4326
71152602|NCT02469870|141797128|SUPERIORITY|||||||0.598|||||||ANCOVA|||To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.||||.598
71152603|NCT02469870|141797129|SUPERIORITY|||||||0.81|||||||ANCOVA|||. To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.||||.81
71152604|NCT02469870|141797130|SUPERIORITY|||||||0.404|||||||ANCOVA|||. To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.||||.404
71152605|NCT02469870|141797131|SUPERIORITY|||||||0.246|||||||ANCOVA|||. To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.||||.246
71152606|NCT02469870|141797132|SUPERIORITY|||||||0.007|||||||ANCOVA|||. To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.||||.007
71152607|NCT02469870|141797133|SUPERIORITY|||||||0.045|||||||t-test, 2 sided|||Two-sample t-test||||.045
71152608|NCT02039843|141797134|SUPERIORITY|||||||0.052||||||Two-sided a priori alpha level was 0.05.|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in WHO-DAS score adjusted for gender, site, baseline score, time \& timeXgroup interaction||||||0.052
71152609|NCT02039843|141797135|SUPERIORITY|||||||0.421||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in PCS score adjusted for gender, site, baseline score, time, and timeXgroup||||||0.421
71152610|NCT02039843|141797136|SUPERIORITY|||||||0.606||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in MCS score adjusted for gender, site, baseline score, time, and timeXgroup||||||0.606
71152611|NCT02039843|141797137|SUPERIORITY|||||||0.21||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in PSQI score adjusted for gender, site, baseline score, time, and timeXgroup||||||0.210
71152612|NCT02039843|141797138|SUPERIORITY|||||||0.036||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in PCL-5 score adjusted for gender, site, baseline score, time, and timeXgroup||||||0.036
71152613|NCT02039843|141797139|SUPERIORITY|||||||0.079||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in PHQ-9 score adjusted for gender, site, baseline score, time, and timeXgroup||||||0.079
71152614|NCT02039843|141797140|SUPERIORITY|||||||0.155||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in DAR score adjusted for gender, site, baseline score, time, and timeXgroup||||||0.155
71152615|NCT02039843|141797141|SUPERIORITY|||||||0.157||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Generalized linear mixed repeated measures analysis on group difference in SBI adjusted for gender, site, baseline SBI, time, and timeXgroup||||||0.157
71152616|NCT02039843|141797142|SUPERIORITY|||||||0.43||||||p-value from random effects regression controlling for month and baseline outcome|Regression, Linear|||||||0.430
71152617|NCT02039843|141797143|SUPERIORITY|||||||0.358||||||p-value from random effects regression controlling for month and baseline outcome|Regression, Linear|||||||0.358
71152618|NCT02039843|141797144|SUPERIORITY|||||||0.39||||||p-value from random effects regression controlling for month and baseline outcome|Regression, Linear|||||||0.39
71152619|NCT02039843|141797154|SUPERIORITY|||||||0.383||||||p-value from random effects regression controlling for month and baseline outcome|Regression, Linear|||||||0.383
71152620|NCT02039843|141797155|SUPERIORITY|||||||0.932|||||||Regression, Linear|||||||0.932
71152621|NCT00806819|141797160|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0435|TWO_SIDED|95.0|0.7|0.99|||Regression, Cox||HR below 1 favors nintedanib|HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no).||0.99|0.70|0.0435
71152622|NCT00806819|141797161|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.894|TWO_SIDED|95.0|0.85|1.21|||Regression, Cox||HR below 1 favors nintedanib|HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (adenocarcinoma vs non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no).||1.21|0.85|0.8940
71152623|NCT00806819|141797162|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0506|TWO_SIDED|95.0|0.7|1.0|||Regression, Cox||HR below 1 favors nintedanib|HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)||1.00|0.70|0.0506
71152624|NCT00806819|141797163|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.0865|TWO_SIDED|95.0|0.73|1.02|||Regression, Cox||HR below 1 favors nintedanib|HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)||1.02|0.73|0.0865
71152625|NCT00806819|141797164|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.7279|TWO_SIDED|95.0|0.65|1.85||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on the central independent review||1.85|0.65|0.7279
71152626|NCT00806819|141797164|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.518|TWO_SIDED|95.0|0.75|1.76||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on the investigator's assessment||1.76|0.75|0.5180
71152627|NCT00806819|141797167|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.0387|TWO_SIDED|95.0|1.02|1.85||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on the central independent review||1.85|1.02|0.0387
71091958|NCT05172609|141690430|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing screening use at Time 3: two weeks after completing the training||||.88
71152628|NCT00806819|141797167|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.1071|TWO_SIDED|95.0|0.95|1.75||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on investigator's assessment||1.75|0.95|0.1071
71152629|NCT00806819|141797169|SUPERIORITY_OR_OTHER|||||||0.1558|TWO_SIDED|||||P-value generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|ANOVA|||Analysis based on the central independent review||||0.1558
71152630|NCT00806819|141797169|SUPERIORITY_OR_OTHER|||||||0.0565|TWO_SIDED|||||P-value generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|ANOVA|||Analysis based on the investigator's assessment||||0.0565
71152631|NCT00806819|141797170|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.5068|TWO_SIDED|95.0|0.74|1.16|||Regression, Cox||HR below 1 favors nintedanib|HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no).||1.16|0.74|0.5068
71152632|NCT00806819|141797171|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.1181|TWO_SIDED|95.0|0.66|1.05|||Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of cough. HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs \>=1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)||1.05|0.66|0.1181
71152633|NCT00806819|141797171|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.4264|TWO_SIDED|95.0|0.77|1.12|||Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of dyspnoea. HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs \>=1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no).||1.12|0.77|0.4264
71152634|NCT00806819|141797171|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.8929|TWO_SIDED|95.0|0.84|1.23|||Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of pain. HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs \>= 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no).||1.23|0.84|0.8929
71152635|NCT04901715|141797248|OTHER|||||||0.002|||||||ANOVA|||||||0.002
71152636|NCT04901715|141797248|OTHER|||||||0.054|||||||ANOVA|||||||0.054
71152637|NCT04901715|141797248|OTHER|||||||0.27|||||||ANOVA|||||||0.27
71152638|NCT04901715|141797249|OTHER|||||||0.014|||||||ANOVA|||||||0.014
71152639|NCT04901715|141797249|OTHER|||||||0.066|||||||ANOVA|||||||0.066
71152640|NCT04901715|141797249|OTHER|||||||0.58|||||||ANOVA|||||||0.58
71152641|NCT03843541|141797252|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_DEVIATION|0.763|<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the superiority comparisons of NAC vs. placebo, the Bonferroni correction was used.||||<0.001
71152642|NCT03843541|141797253|SUPERIORITY||Mean Difference (Net)|-0.29|STANDARD_DEVIATION|0.783||0.002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the superiority comparisons of NAC vs. placebo, the Bonferroni correction was used.||||0.002
71091959|NCT05172609|141690430|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing screening use at Time 4: 12 weeks after completing the training||||.55
71152643|NCT03843541|141797254|SUPERIORITY|||||||0.239|||||||Stratified Mann-Whitney U Statistic|||||||0.239
71152644|NCT03843541|141797255|SUPERIORITY|||||||0.037|||||||Stratified Mann-Whitney U Statistic|||For the superiority comparisons of NAC vs. placebo, the Bonferroni correction was used.||||0.037
71152645|NCT03843541|141797256|SUPERIORITY|||||||0.093|||||||Stratified Mann Whitney U Statistic|||||||0.093
71152646|NCT03843541|141797256|SUPERIORITY|||||||0.118|||||||Stratified Mann Whitney U Statistic|||||||0.118
71152647|NCT03843541|141797257|SUPERIORITY|||||||0.022|||||||Stratified Mann Whitney U Statistic|||||||0.022
71091960|NCT05172609|141690430|SUPERIORITY|||||||0.36|||||||ANCOVA|||repeated measures analysis of covariance (ANCOVA), controlling for organization: CSR screening at timepoints 1, 3, and 4||||.36
71152648|NCT03843541|141797257|SUPERIORITY|||||||0.11|||||||Stratified Mann Whitney U Statistic|||||||0.110
71152649|NCT03843541|141797258|SUPERIORITY|||||||0.022|||||||Stratified Mann Whitney U Statistic|||||||0.022
71152650|NCT03843541|141797258|SUPERIORITY|||||||0.402|||||||Stratified Mann Whitney U Statistic|||||||0.402
71152651|NCT03843541|141797259|NON_INFERIORITY|Non-inferiority was declared if the one-sided confidence interval was within the interval.|Probability scale treatment difference|0.5||||0.002|TWO_SIDED|97.5|0.43|1.0|||Modified Mann-Whitney U Statistic||The point estimates of treatment differences in probability scale together with associated one-side confidence interval (97.5% or 98.75%) were computed according to Hochberg if both superiority contrasts were found statistically significant.|||1.00|0.43|0.002
71152652|NCT03843541|141797260|NON_INFERIORITY|Non-inferiority was declared if the one-sided confidence interval was within the interval.|Probability scale treatment difference|0.5|||<|0.001|TWO_SIDED|98.75|0.45|1.0|||Modified Mann-Whitney U Statistic||"The point estimates of treatment differences in probability scale together with associated one-side confidence interval (97.5% or 98.75%) were computed according to Hochberg if both superiority contrasts were found statistically significant.~."|||1.00|0.45|<0.001
71152653|NCT03843541|141797261|SUPERIORITY|||||||0.356|||||||Modified Mann-Whitney U Statistic|||||||0.356
71152654|NCT03843541|141797261|SUPERIORITY|||||||0.007|||||||Modified Mann-Whitney U Statistic|||||||0.007
71152655|NCT03843541|141797262|SUPERIORITY|||||||0.38|||||||Modified Mann-Whitney U Statistic|||||||0.380
71152656|NCT03843541|141797262|SUPERIORITY|||||||0.018|||||||Modified Mann-Whitney U Statistic|||||||0.018
71152657|NCT03843541|141797263|SUPERIORITY|||||||0.366|||||||Modified Mann-Whitney U Statistic|||||||0.366
71152658|NCT03843541|141797263|SUPERIORITY|||||||0.027|||||||Modified Mann-Whitney U Statistic|||||||0.027
71152659|NCT03843541|141797264|SUPERIORITY|||||||0.052|||||||Modified Mann-Whitney U Statistic|||||||0.052
71152660|NCT03843541|141797264|SUPERIORITY|||||||0.058|||||||Modified Mann-Whitney U Statistic|||||||0.058
71152661|NCT03843541|141797265|SUPERIORITY|||||||0.309|||||||Modified Mann-Whitney U Statistic|||||||0.309
70969752|NCT00530270|141445096|SUPERIORITY_OR_OTHER|||||||0.77||95.0||||A two-sided alpha of 0.05 was used. No multiple comparison adjustments were made.|Mixed Models Analysis|Different error variance estimates were allowed for the two treatment groups.||The null hypothesis of no difference in the log duration of signs and symptoms or hospitalization between the two treatment groups was tested using an F test from a generalized mixed model with fixed effects for treatment group, age group and ACS severity. Please note that the study was stopped prematurely so only 11 of the 112 originally planned were included in the analysis.||||0.770
70969753|NCT02324920|141445097|SUPERIORITY||Hazard Ratio (HR)|0.22|||<|0.001|TWO_SIDED|95.0|0.11|0.46|||Regression, Cox||||Additional models were implemented to control for country and investigational sites effect on primary endpoint.|0.46|0.11|<0.001
70969754|NCT02324920|141445098|SUPERIORITY||Hazard Ratio (HR)|0.45||||0.002|TWO_SIDED|95.0|0.27|0.75|||Regression, Cox|||||0.75|0.27|0.002
70969755|NCT03972969|141445100|SUPERIORITY||Incidence Rate Ratio|0.13|||<|0.05|TWO_SIDED|95.0|0.05|0.32|||negative binomial regression|||||0.32|0.05|<0.05
70969756|NCT03972969|141445100|SUPERIORITY||Incidence Rate Ratio|0.25|||<|0.05|TWO_SIDED|95.0|0.1|0.61|||negative binomial regression|||||0.61|0.10|<0.05
70969757|NCT03972969|141445100|SUPERIORITY||Incidence Rate Ratio|0.52|||<|0.05|TWO_SIDED|95.0|0.19|1.38|||negative binomial regression|||||1.38|0.19|<0.05
70969758|NCT03972969|141445101|SUPERIORITY||Incidence Rate Ratio|0.15|||<|0.05|TWO_SIDED|95.0|0.07|0.33|||negative binomial regression|||||0.33|0.07|<0.05
70969759|NCT03972969|141445101|SUPERIORITY||Incidence Rate Ratio|0.26|||<|0.05|TWO_SIDED|95.0|0.11|0.58|||negative binomial regression|||||0.58|0.11|<0.05
70969760|NCT03972969|141445101|SUPERIORITY||Incidence Rate Ratio|0.58|||<|0.05|TWO_SIDED|95.0|0.25|1.38|||negative binomial regression|||||1.38|0.25|<0.05
71152662|NCT03843541|141797265|SUPERIORITY|||||||0.006|||||||Modified Mann-Whitney U Statistic|||||||0.006
70969761|NCT01399788|141445107|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|103.81|||||TWO_SIDED|90.0|99.2|108.64||||||Rifampicin; 32 participants (16 per sequence) provided at least 99% power that 90% confidence interval (CI) for ratio of test to reference for AUClast lie within acceptance region of 80% - 125%. An intra-subject coefficient of variation (CV) estimate of approximately 14.5% for AUClast was used for this power calculation. Natural log transformed AUClast was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||108.64|99.20|
70969762|NCT01399788|141445107|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|107.28|||||TWO_SIDED|90.0|101.95|112.9||||||Isoniazid; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for AUClast lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 12.0% for AUClast was used for this power calculation. Natural log transformed AUClast was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||112.90|101.95|
71091961|NCT05172609|141690431|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing total SPIRS score at Time 3: two weeks after completing the training||||.24
71091962|NCT05172609|141690431|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing total SPIRS score at Time 4: 12 weeks after completing the training||||.88
70969763|NCT01399788|141445107|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|99.48|||||TWO_SIDED|90.0|94.92|104.25||||||Ethambutol; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for AUClast lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 12.9% for AUClast was used for this power calculation. Natural log transformed AUClast was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||104.25|94.92|
70969764|NCT01399788|141445108|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|102.75|||||TWO_SIDED|90.0|95.36|110.71||||||Rifampicin: 32 participants (16 per sequence) provided at least 98% power that 90% CI for ratio of test to reference for Cmax lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 18.2% for Cmax was used for this power calculation. Natural log transformed Cmax was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||110.71|95.36|
70969765|NCT01399788|141445108|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|103.85|||||TWO_SIDED|90.0|92.13|117.07||||||Isoniazid; 32 participants (16 per sequence) provided at least 98% power that 90% CI for ratio of test to reference for Cmax lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 18.2% for Cmax was used for this power calculation. Natural log transformed Cmax was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||117.07|92.13|
70969766|NCT01399788|141445108|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|99.48|||||TWO_SIDED|90.0|94.92|104.25||||||Ethambutol; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for Cmax lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 16.0% for Cmax was used for this power calculation. Natural log transformed Cmax was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||104.25|94.92|
70969767|NCT01399788|141445109|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|101.73|||||TWO_SIDED|90.0|99.12|104.4||||||Pyrazinamide; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for AUClast lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 5.2% for AUClast was used for this power calculation. Natural log transformed AUClast(dn) was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||104.40|99.12|
70969768|NCT01399788|141445110|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|95.17|||||TWO_SIDED|90.0|88.6|102.22||||||Pyrazinamide; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for Cmax lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 6.7% for Cmax was used for this power calculation. Natural log transformed Cmax(dn) was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||102.22|88.60|
71091963|NCT05172609|141690431|SUPERIORITY|||||||0.1|||||||ANCOVA|||repeated measures analysis of covariance (ANCOVA), controlling for organization: SPIRS at timepoints 3 and 4||||.10
71152663|NCT05767749|141797282|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.93|TWO_SIDED|95.0|-12.8|14.0|||t-test, 2 sided||Direction = (Lidocaine + epinephrine vs Ropivacaine) minus (Lidocaine + epinephrine vs Bupivacaine)|||14.0|-12.8|0.93
71152664|NCT05767749|141797282|SUPERIORITY||Mean Difference (Final Values)|3.73||||0.54|TWO_SIDED|95.0|-8.3|15.8|||t-test, 2 sided||Direction = (Lidocaine + epinephrine vs Ropivacaine) minus (Ropivacaine vs Bupivacaine)|||15.8|-8.3|0.54
71152665|NCT05767749|141797282|SUPERIORITY||Mean Difference (Final Values)|3.12||||0.6|TWO_SIDED|95.0|-8.7|15.0|||t-test, 2 sided||Direction = (Lidocaine + epinephrine vs Bupivacaine) minus (Ropivacaine vs Bupivacaine)|||15.0|-8.7|0.60
71152666|NCT01077050|141797285|SUPERIORITY_OR_OTHER||Sensitivity to Melanoma|96.6|||||ONE_SIDED|95.0|94.2|||The point estimate of the observed sensitivity that is based on generalized linear mixed model is equal to that calculated in the usual manner.|Clopper-Pearson 1-sided||||||94.2|
71152667|NCT01077050|141797285|SUPERIORITY_OR_OTHER||Sensitivity to Basal Cell Carcinoma|100.0|||||TWO_SIDED|95.0|92.6|100.0|||Clopper-Pearson 2-sided|Point estimate of the observed sensitivity for Basal Cell Carcinoma||||100|92.6|
71152668|NCT01077050|141797285|SUPERIORITY_OR_OTHER||Observed sensitivity for squamous cell c|93.3|||||TWO_SIDED|95.0|68.1|99.8|||Clopper-Pearson 2-sided|Point estimate of the observed sensitivity for squamous cell carcinoma||||99.8|68.1|
71152669|NCT01077050|141797285|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.0|||<|0.0001|TWO_SIDED|95.0|6.6|25.5|||Mixed Models Analysis|Note that calculating odds ratio adjusting for subjects having multiple lesions, yields similar result.||||25.5|6.6|<0.0001
71152670|NCT03894813|141797287|NON_INFERIORITY|The relevant parameters were determined as follows: test level α=0.05, test power 1-β=0.80, Pt=0.90, Pc=0.75, Nt:Nc=1:1, boundary value Δ= -0.0.068 (excellent), and Fisher's exact test. As a result, the sample size of each group was calculated as 50 patients, 100 patients in total. Considering a loss to follow-up rate of 20%, a sample size of 120 patients was finally determined, with 60 patients in each group.|||||<|0.01|||||||Chi-squared|||||||<0.01
71152671|NCT03894813|141797288|NON_INFERIORITY|The relevant parameters were determined as follows: test level α=0.05, test power 1-β=0.80, Pt=0.90, Pc=0.75, Nt:Nc=1:1, boundary value Δ= -0.0.068 (excellent), and Fisher's exact test. As a result, the sample size of each group was calculated as 50 patients, 100 patients in total. Considering a loss to follow-up rate of 20%, a sample size of 120 patients was finally determined, with 60 patients in each group.|||||<|0.01|||||||Chi-squared|||||||<0.01
71152672|NCT03894813|141797289|NON_INFERIORITY|The relevant parameters were determined as follows: test level α=0.05, test power 1-β=0.80, Pt=0.90, Pc=0.75, Nt:Nc=1:1, boundary value Δ= -0.0.068 (excellent), and Fisher's exact test. As a result, the sample size of each group was calculated as 50 patients, 100 patients in total. Considering a loss to follow-up rate of 20%, a sample size of 120 patients was finally determined, with 60 patients in each group.|||||<|0.01|||||||Chi-squared|||||||<0.01
71152673|NCT03894813|141797290|NON_INFERIORITY|The relevant parameters were determined as follows: test level α=0.05, test power 1-β=0.80, Pt=0.90, Pc=0.75, Nt:Nc=1:1, boundary value Δ= -0.0.068 (excellent), and Fisher's exact test. As a result, the sample size of each group was calculated as 50 patients, 100 patients in total. Considering a loss to follow-up rate of 20%, a sample size of 120 patients was finally determined, with 60 patients in each group.|||||<|0.01|||||||Chi-squared|||||||<0.01
71152674|NCT03894813|141797291|NON_INFERIORITY|The relevant parameters were determined as follows: test level α=0.05, test power 1-β=0.80, Pt=0.90, Pc=0.75, Nt:Nc=1:1, boundary value Δ= -0.0.068 (excellent), and Fisher's exact test. As a result, the sample size of each group was calculated as 50 patients, 100 patients in total. Considering a loss to follow-up rate of 20%, a sample size of 120 patients was finally determined, with 60 patients in each group.|||||<|0.01|||||||Chi-squared|||||||<0.01
71152675|NCT02656693|141797366|SUPERIORITY|||||||0.00017|||||||Mixed Models Analysis|||||||0.00017
71152676|NCT02656693|141797368|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||< 0.001
71152677|NCT02656693|141797370|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||< 0.001
71152678|NCT02656693|141797371|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
71152679|NCT02656693|141797373|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71152680|NCT02656693|141797374|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
71152681|NCT02656693|141797375|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||||||0.0001
70969769|NCT01399788|141445111|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|104.3|||||TWO_SIDED|90.0|99.7|109.1||||||Rifampicin; Natural log transformed AUC(0-∞) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||109.10|99.70|
71152682|NCT02656693|141797376|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|||||||0.19
71152683|NCT02656693|141797377|SUPERIORITY|||||||0.35|||||||Mixed Models Analysis|||||||0.35
71152684|NCT02656693|141797378|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
71152685|NCT02656693|141797379|SUPERIORITY|||||||0.33|||||||Mixed Models Analysis|||||||0.33
71152686|NCT02656693|141797380|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||||||0.43
71152687|NCT02656693|141797381|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||||||0.40
71152688|NCT02656693|141797382|SUPERIORITY|||||||0.16|||||||Mixed Models Analysis|||||||0.16
71152689|NCT02656693|141797383|SUPERIORITY|||||||0.61|||||||Mixed Models Analysis|||||||0.61
71152690|NCT02656693|141797384|SUPERIORITY|||||||0.61|||||||Mixed Models Analysis|||||||0.61
71152691|NCT02656693|141797385|SUPERIORITY|||||||0.46|||||||Mixed Models Analysis|||||||0.46
71152692|NCT02656693|141797386|SUPERIORITY|||||||0.68|||||||Mixed Models Analysis|||||||0.68
71152693|NCT02656693|141797387|SUPERIORITY|||||||0.54|||||||Mixed Models Analysis|||||||0.54
71152694|NCT02656693|141797388|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
71152695|NCT02656693|141797389|SUPERIORITY|||||||0.42|||||||Mixed Models Analysis|||||||0.42
71152696|NCT02656693|141797390|SUPERIORITY|||||||0.23|||||||Mixed Models Analysis|||||||0.23
71152697|NCT02656693|141797391|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
71152698|NCT02642315|141797457|OTHER||Median Difference (Net)|36.0||||0.0131|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0131
71152699|NCT02642315|141797458|OTHER||Median Difference (Net)|36.0||||0.0131|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0131
71152700|NCT00662675|141797480|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|The p-value is from ANCOVA model with treatment as a factor and baseline percent COA-fat as a covariate.||The power calculation was based on the assumption that the true mean difference between the active and the placebo group was 31.2% with a common standard deviation of 22.6% using a 2-sided, 2-sample, t-test with a 5% significance level.||||<0.001
71152701|NCT00662675|141797481|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is from ANCOVA model with treatment as a factor and baseline percent COA-protein(nitrogen) as a covariate.|ANCOVA|||||||<0.001
71152702|NCT02873702|141797508|NON_INFERIORITY|Non-inferiority to lansoprazole if the lower bound of confidence interval (CI) for the treatment difference is greater than -10%.|Difference in Percentage|-2.65|||||TWO_SIDED|95.0|-26.59|21.3||||||Healing Period: Dexlansoprazole 60 mg versus Healing Period: Lansoprazole 30 mg||21.30|-26.59|
71152703|NCT01039376|141797516|SUPERIORITY||Hazard Ratio (HR)|0.55|||<|0.0001|TWO_SIDED|95.0|0.43|0.7|||Stratified log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of \<1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.|||0.70|0.43|<0.0001
71152704|NCT01039376|141797517|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.42|0.68|||Stratified log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of \<1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.|||0.68|0.42|<0.0001
71152705|NCT01039376|141797518|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.6046|TWO_SIDED|95.0|0.69|1.25|||Stratified log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of \<1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.|||1.25|0.69|0.6046
71152706|NCT01039376|141797520|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0178|TWO_SIDED|95.0|0.62|0.96|||Stratified log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of \<1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.|||0.96|0.62|0.0178
71152707|NCT01039376|141797521|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.3136|TWO_SIDED|95.0|0.42|1.32|||log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of \<1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.|||1.32|0.42|0.3136
71152708|NCT01039376|141797522|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.1603|TWO_SIDED|95.0|0.29|1.19|||log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of \<1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.|||1.19|0.29|0.1603
71152709|NCT01039376|141797523|SUPERIORITY||Mean Difference (Final Values)|-2.19||||0.0199|TWO_SIDED|95.0|-4.04|-0.35||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Disease Effects Scale|||-0.35|-4.04|0.0199
71152710|NCT01039376|141797523|SUPERIORITY||Mean Difference (Final Values)|-3.79||||0.0085|TWO_SIDED|95.0|-6.61|-0.97||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Fatigue Scale|||-0.97|-6.61|0.0085
71152711|NCT01039376|141797523|SUPERIORITY||Mean Difference (Final Values)|-3.58||||0.0642|TWO_SIDED|95.0|-7.37|0.21||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Future Health Scale|||0.21|-7.37|0.0642
71091964|NCT01080261|141690487|NON_INFERIORITY_OR_EQUIVALENCE|Study had 91% statistical power to demonstrate that the 9-month rate for MACE (accounting for an expected 9-month attrition rate of 10%) is less than the performance goal, assuming a 9-month MACE rate of 8.2%.|Percent of patients experiencing a MACE|0.0|||<|0.0001|ONE_SIDED|95.0||4.9|||One-group exact binomial test|||A one-group exact binomial test was used to test the hypothesis that the percentage of patients experiencing a MACE event (primary endpoint) in the PROMUS Element cohort is less than the predefined performance goal of 24.1% (based on historical outcomes with plain balloon angioplasty \[20.2%\] plus an adjustment of 3.9% for small vessels).||4.9||<0.0001
71152712|NCT01039376|141797523|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.6398|TWO_SIDED|95.0|-1.67|2.72||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Infection Scale|||2.72|-1.67|0.6398
71152713|NCT01039376|141797523|SUPERIORITY||Mean Difference (Final Values)|-4.32||||0.0055|TWO_SIDED|95.0|-7.37|-1.28||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Social Problems Scale|||-1.28|-7.37|0.0055
71152714|NCT01039376|141797523|SUPERIORITY||Mean Difference (Final Values)|-2.49||||0.0063|TWO_SIDED|95.0|-4.27|-0.71||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Side Effects Scale|||-0.71|-4.27|0.0063
71152715|NCT01039376|141797524|SUPERIORITY||Mean Difference (Final Values)|-1.48||||0.1816|TWO_SIDED|95.0|-3.64|0.69||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Appetite Loss|||0.69|-3.64|0.1816
71152716|NCT01039376|141797524|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.2863|TWO_SIDED|95.0|-1.18|3.97||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Cognitive Functioning|||3.97|-1.18|0.2863
71152717|NCT01039376|141797524|SUPERIORITY||Mean Difference (Final Values)|-1.97||||0.0932|TWO_SIDED|95.0|-4.28|0.33||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Constipation|||0.33|-4.28|0.0932
71152718|NCT01039376|141797524|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.6533|TWO_SIDED|95.0|-1.67|2.66||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Diarrhoea|||2.66|-1.67|0.6533
71152719|NCT01039376|141797524|SUPERIORITY||Mean Difference (Final Values)|-2.32||||0.0963|TWO_SIDED|95.0|-5.06|0.42||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Dyspnoea|||0.42|-5.06|0.0963
71152720|NCT01039376|141797524|SUPERIORITY||Mean Difference (Final Values)|3.89||||0.0037|TWO_SIDED|95.0|1.27|6.51||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Emotional Functioning|||6.51|1.27|0.0037
71152721|NCT01039376|141797524|SUPERIORITY||Mean Difference (Final Values)|-4.63||||0.0013|TWO_SIDED|95.0|-7.45|-1.82||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Fatigue|||-1.82|-7.45|0.0013
71152722|NCT01039376|141797524|SUPERIORITY||Mean Difference (Final Values)|-1.76||||0.2902|TWO_SIDED|95.0|-5.02|1.51||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Financial Difficulties|||1.51|-5.02|0.2902
71152723|NCT01039376|141797524|SUPERIORITY||Mean Difference (Final Values)|-1.22||||0.0606|TWO_SIDED|95.0|-2.49|0.05||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Nausea and Vomiting|||0.05|-2.49|0.0606
71152724|NCT01039376|141797524|SUPERIORITY||Mean Difference (Final Values)|-3.04||||0.0393|TWO_SIDED|95.0|-5.93|-0.15||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Pain|||-0.15|-5.93|0.0393
71152725|NCT01039376|141797524|SUPERIORITY||Mean Difference (Final Values)|1.81||||0.0968|TWO_SIDED|95.0|-0.33|3.96||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Physical Functioning|||3.96|-0.33|0.0968
71152726|NCT01039376|141797524|SUPERIORITY||Mean Difference (Final Values)|1.78||||0.1449|TWO_SIDED|95.0|-0.61|4.17||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Global Health Status/QOL|||4.17|-0.61|0.1449
71152727|NCT01039376|141797524|SUPERIORITY||Mean Difference (Final Values)|3.56||||0.0259|TWO_SIDED|95.0|0.43|6.7||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Role Functioning|||6.70|0.43|0.0259
71152728|NCT01039376|141797524|SUPERIORITY||Mean Difference (Final Values)|3.65||||0.0175|TWO_SIDED|95.0|0.64|6.65||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Social Functioning|||6.65|0.64|0.0175
71152729|NCT01039376|141797524|SUPERIORITY||Mean Difference (Final Values)|-1.79||||0.3209|TWO_SIDED|95.0|-5.33|1.75||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Insomnia|||1.75|-5.33|0.3209
71152730|NCT01039376|141797525|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.011|TWO_SIDED|95.0|0.01|0.06||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Utility Score|||0.06|0.01|0.0110
71152731|NCT01039376|141797525|SUPERIORITY||Mean Difference (Final Values)|1.38||||0.1999|TWO_SIDED|95.0|-0.73|3.49||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Thermometer Score|||3.49|-0.73|0.1999
71152732|NCT01039376|141797537|SUPERIORITY||Hazard Ratio (HR)|1.547|||||TWO_SIDED|95.0|1.051|2.276|||||HR estimated for Cytogenetics Group (based on \>=20% cut-off) with 6q-, or +12q or 13q-/no abberation|||2.276|1.051|
71152733|NCT01039376|141797537|SUPERIORITY||Hazard Ratio (HR)|9.303|||||TWO_SIDED|95.0|4.934|17.54|||||HR estimated for Cytogenetics Group (based on \>=20% cut-off) with 17p-/no abberation|||17.540|4.934|
71152734|NCT01039376|141797537|SUPERIORITY||Hazard Ratio (HR)|4.219|||||TWO_SIDED|95.0|2.468|7.21|||||HR estimated for Cytogenetics Group (based on \>=20% cut-off) with 11q-/no abberation|||7.210|2.468|
71152735|NCT01039376|141797537|SUPERIORITY||Hazard Ratio (HR)|1.832|||||TWO_SIDED|95.0|1.434|2.339|||||HR estimated for B2 Microglobulin Group 2 with 3500 as cut off: \>3500 ug/L/\<=3500 ug/L|||2.339|1.434|
71152736|NCT01039376|141797537|SUPERIORITY||Hazard Ratio (HR)|0.573|||||TWO_SIDED|95.0|0.432|0.76|||||HR estimated for IgVH Mutational Status 1 Mutated/Unmutated|||0.760|0.432|
71152737|NCT01039376|141797537|SUPERIORITY||Hazard Ratio (HR)|1.301|||||TWO_SIDED|95.0|0.692|2.448|||||HR estimated for VH3-21 Usage Flag Yes/No.|||2.448|0.692|
71152738|NCT01499277|141797566|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the observed difference in the primary outcome measures (clinical cure rates) between ceftaroline group and vancomycin plus aztreonam group were calculated in both MITT and CE Populations at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10% in both MITT and CE Populations.|Risk Difference (RD)|-0.95|||||TWO_SIDED|95.0|-6.9|5.41||||RD is the difference in clinical cure rates (Ceftaroline minus Vancomycin/Aztreonam). CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared vancomycin plus azreonam group at TOC in both MITT and CE populations.||5.41|-6.9|
71152739|NCT01499277|141797567|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the observed difference in the primary outcome measures (clinical cure rates) between ceftaroline group and vancomycin plus aztreonam group were calculated in both MITT and CE Populations at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10% in both MITT and CE Populations. If non-inferioirity was achieved then a test of superioirty was conducted if lower limit of 95% CI for the difference was \>0%.|Risk Difference (RD)|1.27|||||TWO_SIDED|95.0|-4.32|7.48||||RD is the difference in clinical cure rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared vancomycin plus azreonam group at TOC in both MITT and CE populations.||7.48|-4.32|
71152740|NCT01499277|141797568|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.71|||||TWO_SIDED|95.0|-6.21|10.39||||RD is the difference in favorable rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|||10.39|-6.21|
71152741|NCT01499277|141797569|SUPERIORITY_OR_OTHER||Risk Difference (RD)|4.77|||||TWO_SIDED|95.0|-2.11|12.86||||RD is the difference in favorable rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|||12.86|-2.11|
71152742|NCT01499277|141797570|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.25|||||TWO_SIDED|95.0|-4.05|7.06||||RD is the difference in cure rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|||7.06|-4.05|
71152743|NCT01499277|141797571|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.92|||||TWO_SIDED|95.0|-2.19|8.73||||RD is the difference in cure rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|||8.73|-2.19|
71152744|NCT01499277|141797572|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.79|||||TWO_SIDED|95.0|-3.98|1.18||||RD is the difference in relapse rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|||1.18|-3.98|
71152745|NCT01499277|141797573|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.86|||||TWO_SIDED|95.0|-6.34|3.15||||RD is the difference in success rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|||3.15|-6.34|
71152746|NCT04661579|141797575|OTHER||Vaccine Efficacy|35.9||||0.009|TWO_SIDED|95.0|10.3|54.2|||Wald test||Vaccine efficacy (VE) is defined as the percent reduction in the hazard, i.e. one minus the hazard ratio (HR, RTS,S/AS01E Vaccine vs. Rabies vaccine).|Vaccine efficacy against the first PCR-positive P. falciparum infection among adults who were P. falciparum positive at baseline was assessed using Cox proportional hazards regression model with a covariate for group assignment to compare Groups 1 and 4. HIV status, Age (tertiles), and sleep under a bednet were included as covariates.||54.2|10.3|0.009
71152747|NCT04661579|141797576|OTHER||Vaccine Efficacy|-24.0||||0.369|TWO_SIDED|95.0|-97.0|22.2|||Wald test||Vaccine efficacy (VE) is defined as the percent reduction in the hazard, i.e. one minus the hazard ratio (HR, RTS,S/AS01E Vaccine vs. Rabies vaccine).|Vaccine efficacy against the first PCR-positive P. falciparum infection among adults who were P. falciparum positive at baseline was assessed using Cox proportional hazards regression model with a covariate for group assignment to compare Groups 2 and 5. HIV status, Age (tertiles), and sleep under a bednet were included as covariates.||22.2|-97|0.369
71152748|NCT04730271|141797590|NON_INFERIORITY|Test of non-inferiority: Absolute value deviation from plan with ROBOTIC is less than it is with manual instruments (not using ROBOTIC) under a non-inferiority margin of 1.5 degrees|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
71152749|NCT04730271|141797591|SUPERIORITY|||||||0.0058|||||||t-test, 2 sided|||||||0.0058
71152750|NCT04730271|141797592|SUPERIORITY|||||||0.0282|||||||t-test, 2 sided|||||||0.0282
71152751|NCT04730271|141797593|SUPERIORITY|||||||0.0004|||||||t-test, 2 sided|||||||0.0004
71152752|NCT04730271|141797594|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71152753|NCT04730271|141797595|SUPERIORITY|||||||0.633|||||||Chi-squared|||Comparison between the proportion of Robotic and Manual subjects who had a local adverse event within 1 year of the procedure.||||0.6330
71152754|NCT04730271|141797595|SUPERIORITY|||||||0.04|||||||Fisher Exact|||Comparison between the proportion of Robotic and Manual subjects who had a serious local adverse event within 1 year of the procedure.||||0.0400
71152755|NCT04730271|141797595|SUPERIORITY|||||||0.4079|||||||Chi-squared|||Comparison between the proportion of Robotic and Manual subjects who had a local adverse event within 90 days of the procedure.||||0.4079
71152756|NCT04730271|141797595|SUPERIORITY|||||||0.1262|||||||Chi-squared|||Comparison between the proportion of Robotic and Manual subjects who had a local serious adverse event within 90 days of the procedure.||||0.1262
71152757|NCT04730271|141797597|SUPERIORITY|||||||0.6662|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 year||||0.6662
71152758|NCT04730271|141797597|SUPERIORITY|||||||0.8154|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeks||||0.8154
71091965|NCT02594111|141690500|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
71152759|NCT04730271|141797598|SUPERIORITY|||||||0.0165|||||||t-test, 2 sided|||Comparison of FJS at 12 weeks||||0.0165
71152760|NCT04730271|141797598|SUPERIORITY|||||||0.1331|||||||t-test, 2 sided|||Comparison of FJS at 1 year||||0.1331
71152761|NCT04730271|141797599|SUPERIORITY|||||||0.1596|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 year||||0.1596
71152762|NCT04730271|141797599|SUPERIORITY|||||||0.6834|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeks||||0.6834
71152763|NCT04730271|141797600|SUPERIORITY|||||||0.5675|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 year||||0.5675
71152764|NCT04730271|141797600|SUPERIORITY|||||||0.924|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeks||||0.9240
71152765|NCT04730271|141797601|SUPERIORITY|||||||0.4586|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 year||||0.4586
71152766|NCT04730271|141797601|SUPERIORITY|||||||0.6951|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeks||||0.6951
71152767|NCT04730271|141797602|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 year||||0.8000
71152768|NCT04730271|141797602|SUPERIORITY|||||||0.973|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeks||||0.9730
71152769|NCT04730271|141797603|SUPERIORITY|||||||0.4636|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 year||||0.4636
71152770|NCT04730271|141797603|SUPERIORITY|||||||0.8088|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeks||||0.8088
71152771|NCT04730271|141797604|SUPERIORITY|||||||0.4851|||||||t-test, 2 sided|||T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL at 12 weeks||||0.4851
71152772|NCT04730271|141797604|SUPERIORITY|||||||0.6486|||||||t-test, 2 sided|||T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL at 1 year||||0.6486
71152773|NCT04730271|141797605|SUPERIORITY|||||||0.8887|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline for Pain at rest between ROBOTIC and MANUAL at 1 year||||0.8887
71152774|NCT04730271|141797605|SUPERIORITY|||||||0.4007|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline for pain at rest between ROBOTIC and MANUAL at 12 weeks||||0.4007
71152775|NCT04730271|141797605|SUPERIORITY|||||||0.0074|||||||t-test, 2 sided|||T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL for pain at rest at 12 weeks||||0.0074
71152776|NCT04730271|141797605|SUPERIORITY|||||||0.0663|||||||t-test, 2 sided|||T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL for Pain at rest at 1 year||||0.0663
71152777|NCT04730271|141797605|SUPERIORITY|||||||0.7096|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL for Pain with Activity at 1 year||||0.7096
71152778|NCT04730271|141797605|SUPERIORITY|||||||0.5321|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL for pain with activity at 12 weeks||||0.5321
71152779|NCT04730271|141797605|SUPERIORITY|||||||0.0709|||||||t-test, 2 sided|||T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL for Pain with activity at 12 weeks||||0.0709
71152780|NCT04730271|141797605|SUPERIORITY|||||||0.1274|||||||t-test, 2 sided|||T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL for Pain with activity at 1 year||||0.1274
71152781|NCT04730271|141797606|SUPERIORITY|||||||0.6745|||||||t-test, 2 sided|||Comparison between the accuracy achieved in the first 10 cases compared to the subsequent cases||||0.6745
71152782|NCT04954833|141797607|NON_INFERIORITY|A non-inferiority margin of 0.05 logMAR. A value of 0.05 logMAR is approximately 2.5 letters on the ETDRS chart.|LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|-0.01|0.02|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test - Control|||0.02|-0.01|
71152783|NCT04954833|141797608|NON_INFERIORITY|A non-inferiority margin of 10% was used. A 10% of difference in the rate of lens fit acceptance is considered clinically significant.|Posterior mean difference of proportions|0.0|STANDARD_DEVIATION|0.0048|||TWO_SIDED|95.0|-0.009|0.01|||Bayesian hierarchical model|A 95% credible interval for the posterior mean difference between the Test and Control (Test - Control) was used to evaluate non-inferiority.|Interval presented is a 95% Credible interval|||0.010|-0.009|
71152784|NCT02023697|141797611|OTHER||Hazard Ratio (HR)|1.057||||0.7047|TWO_SIDED|80.0|0.878|1.272|||Log Rank||Arm B / Arm (A+C)|||1.272|0.878|0.7047
71152785|NCT02023697|141797613|OTHER||Hazard Ratio (HR)|1.26||||0.3134|TWO_SIDED|80.0|0.939|1.69|||Log Rank||Arm C /Arm A|||1.690|0.939|0.3134
71152786|NCT02023697|141797617|OTHER||Hazard Ratio (HR)|1.075||||0.6205|TWO_SIDED|80.0|0.892|1.297|||Log Rank||Arm B/Arm (A+C)|||1.297|0.892|0.6205
71152787|NCT02023697|141797619|OTHER||Hazard Ratio (HR)|0.999||||0.9958|TWO_SIDED|80.0|0.744|1.341|||Log Rank||Arm C/Arm A|||1.341|0.744|0.9958
71152788|NCT02023697|141797623|OTHER||Hazard Ratio (HR)|1.068||||0.7461|TWO_SIDED|80.0|0.823|1.385|||Log Rank||Arm B/Arm (A+C)|||1.385|0.823|0.7461
71152789|NCT02023697|141797625|OTHER||Hazard Ratio (HR)|1.549||||0.155|TWO_SIDED|80.0|1.041|2.306|||Log Rank||Arm C/Arm A|||2.306|1.041|0.1550
71152790|NCT02023697|141797629|OTHER||Hazard Ratio (HR)|0.969||||0.8284|TWO_SIDED|80.0|0.805|1.167|||Log Rank||Arm B/Arm (A+C)|||1.167|0.805|0.8284
71152791|NCT02023697|141797631|OTHER||Hazard Ratio (HR)|1.059||||0.7896|TWO_SIDED|80.0|0.804|1.396|||Log Rank||Arm C/Arm A|||1.396|0.804|0.7896
71152792|NCT02023697|141797635|OTHER||Hazard Ratio (HR)|0.986||||0.9274|TWO_SIDED|80.0|0.803|1.21|||Log Rank||Arm B/Arm (A+C)|||1.210|0.803|0.9274
71152793|NCT02023697|141797637|OTHER||Hazard Ratio (HR)|1.134||||0.5754|TWO_SIDED|80.0|0.85|1.514|||Log Rank||Arm C/Arm A|||1.514|0.850|0.5754
71152794|NCT02023697|141797643|OTHER||Hazard Ratio (HR)|0.898||||0.6214|TWO_SIDED|80.0|0.678|1.188|||Log Rank||Arm B/Arm (A+C)|||1.188|0.678|0.6214
71152795|NCT02023697|141797645|OTHER||Hazard Ratio (HR)|0.863||||0.7214|TWO_SIDED|80.0|0.505|1.475|||Log Rank||Arm C/Arm A|||1.475|0.505|0.7214
71152796|NCT03904693|141797652|SUPERIORITY||Geometric Mean Ratio|0.71|||<|0.0001|TWO_SIDED|95.0|0.61|0.82|||ANCOVA|||||0.82|0.61|<0.0001
71152797|NCT03904693|141797652|SUPERIORITY||Geometric Mean Ratio|0.72|||<|0.0001|TWO_SIDED|95.0|0.64|0.8|||ANCOVA|||||0.80|0.64|<0.0001
71152798|NCT04674761|141797663|SUPERIORITY||LS mean difference|-0.88|STANDARD_ERROR_OF_MEAN|0.277||0.0012|TWO_SIDED|95.0|-1.44|-0.33|||Mixed Models Analysis|||The analysis is based on a mixed model for repeated measures (MMRM) using a restricted maximum likelihood (REML) with baseline score as a covariate, and baseline age stratification, baseline direct bilirubin, treatment group, time (in months), and treatment-by-time interaction as fixed effects. One-sided p-value was reported.||-0.33|-1.44|0.0012
71152799|NCT04674761|141797664|SUPERIORITY||LS mean difference|-112.74|STANDARD_ERROR_OF_MEAN|32.864||0.0006|TWO_SIDED|95.0|-178.78|-46.69|||Mixed Models Analysis|||The analysis is based on a mixed model for repeated measures (MMRM) using a restricted maximum likelihood (REML) with baseline serum bile acid (sBA) concentration data as a covariate, and baseline age stratification, treatment group, visits (Weeks 4, 8, 12, 16, 20, 24), and treatment-by-visit interaction as fixed effects. The comparison of treatment difference in change from baseline to the average of Week 20 and Week 24 is estimated and tested using contrast. One-sided p-value was reported.||-46.69|-178.78|0.0006
71152800|NCT04717336|141797701|SUPERIORITY||Mean of Paired Differences|0.002||||0.98|TWO_SIDED|95.0|-0.22|0.23|||Paired T-Test|A paired t-test was applied across both periods because this is a cross-over study where each participant serves at their own control.||The aim of this analysis is to test whether there is a statistically significant difference in Pulse Wave Velocity when participants are on sodium chloride vs. placebo, regardless of period.||0.23|-0.22|0.98
71152801|NCT01500720|141797702|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|2.169|||<|0.0001|TWO_SIDED|95.0|1.563|3.01||P-value was calculated from stratified two-sided log-rank test, stratifying for brain metastases and lactate dehydrogenase (LDH) level at the time of randomization.|Stratified Two-Sided Log-Rank Test||Hazard ratio was estimated using a COX Proportional Hazards regression model, stratifying for brain metastases and LDH level at the time of randomization.|||3.01|1.563|<0.0001
71152802|NCT04301193|141797767|OTHER||Correlation - R value|0.93|||<|0.05|TWO_SIDED||||||Regression, Linear|||Using standard techniques for estimating sample size, a Delong's test indicated that a total of 61 samples would be sufcient to detect a 0.2 increase in the AUROC from the null hypothesis 0.5, assuming an alpha level of 5% and 90% power \[12\]. The manuscript was referenced against the STROBE checklist for cohort studies. Descriptive statistics were used to present.||||<0.05
71152803|NCT04301193|141797767|OTHER||Correlation - R value|0.77|||<|0.05|TWO_SIDED||||||Regression, Linear|||||||<0.05
71152804|NCT03229941|141797828|SUPERIORITY||Odds Ratio (OR)|0.89||||0.515|TWO_SIDED|95.0|0.62|1.27|||Chi-squared||Liberal vs. restrictive arm comparison.|||1.27|0.62|0.515
71152805|NCT03229941|141797829|SUPERIORITY||Odds Ratio (OR)|1.09||||0.587|TWO_SIDED|99.0|0.73|1.61|||Chi-squared||Liberal vs. Restrictive arm comparison|||1.61|0.73|0.587
71152806|NCT03229941|141797830|SUPERIORITY||Odds Ratio (OR)|0.57||||0.007|TWO_SIDED|99.0|0.33|0.98|||Chi-squared||Liberal vs. Restrictive arm comparison|||0.98|0.33|0.007
71152807|NCT03229941|141797831|SUPERIORITY||Odds Ratio (OR)|0.93||||0.634|TWO_SIDED|99.0|0.63|1.38|||Chi-squared||Liberal vs. Restrictive arm comparison|||1.38|0.63|0.634
71152808|NCT03229941|141797832|SUPERIORITY||Odds Ratio (OR)|0.75||||0.212|TWO_SIDED|99.0|0.41|1.37|||Chi-squared||Liberal vs. Restrictive arm comparison|||1.37|0.41|0.212
71152809|NCT03229941|141797833|SUPERIORITY|||||||0.786|||||||Wilcoxon (Mann-Whitney)|||||||0.786
71152810|NCT00684060|141797834|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0|STANDARD_ERROR_OF_MEAN|8.6|<|0.05|TWO_SIDED|95.0|-7.05|0.95||Threshold 0.05|t-test, 2 sided|No adjustment for multiple comparisons||Comparison of change in global LVEF in the active group minus change in global LVEF in the control group. 80 percent power based on BOOST results||.95|-7.05|<0.05
71152811|NCT00684060|141797835|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3|||<|0.05||95.0|0.08|1.17|||Fisher Exact|||comparison of the proportion of events in patients in the active group to those in patients in the control group||1.17|0.08|<0.05
71152812|NCT00684060|141797836|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|17.2|<|0.05|TWO_SIDED|95.0|-9.3|6.8|||t-test, 2 sided|||Comparison of change in the active group minus change in global LVEF in the control group.||6.8|-9.3|<0.05
71152813|NCT00684060|141797837|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|21.8|<|0.05|TWO_SIDED|95.0|-9.5|10.9|||t-test, 2 sided|||Comparison of change in the active group minus change in global LVEF in the control group.||10.9|-9.5|<0.05
71152814|NCT00684060|141797838|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5|STANDARD_ERROR_OF_MEAN|14.2|<|0.05|TWO_SIDED|95.0|-4.1|9.2|||t-test, 2 sided|||Comparison of change in the active group minus change in the control group.||9.2|-4.1|<0.05
71152815|NCT00684060|141797839|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5|STANDARD_ERROR_OF_MEAN|17.7|<|0.05||95.0|-9.9|6.9|||t-test, 2 sided|||Comparison of change in the active group minus change in the control group.||6.9|-9.9|<0.05
71152816|NCT00684060|141797840|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|4.4|<|0.05|TWO_SIDED|95.0|-2.8|1.3||Unadjusted|t-test, 2 sided|||Comparison of change in infarct zone wall motion in the active group minus change in global LVEF in the control group. 80 percent power based on BOOST results||1.3|-2.8|<0.05
71152817|NCT00684060|141797841|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|6.9|<|0.05||95.0|-6.0|0.8|||t-test, 2 sided|||Comparison of change in border zone wall motion in the active group minus change in global LVEF in the control group. 80 percent power based on BOOST results||0.8|-6.0|<0.05
71152818|NCT03751657|141797842|OTHER||Treatment difference|-0.18||||0.0818|TWO_SIDED|95.0|-0.38|0.02|||Mixed Models Analysis|||The response and change from baseline in response after 26 weeks are analysed using a linear mixed model for repeated measures (MMRM) with an unstructured covariance matrix and treatment, region, use of DPP-4 inhibitor and visit as fixed factors, and baseline response as covariate. Furthermore, the model includes the interaction between visit and all explanatory variables.||0.02|-0.38|0.0818
71152819|NCT03751657|141797856|OTHER||Treatment difference|-1.97||||0.0818|TWO_SIDED|95.0|-4.19|0.25|||Mixed Models Analysis|||The response and change from baseline in response after 26 weeks are analysed using a linear MMRM with an unstructured covariance matrix and treatment, region, use of DPP-4 inhibitor and visit as fixed factors, and baseline response as covariate.Furthermore, the model includes the interaction between visit and all explanatory variables.||0.25|-4.19|0.0818
71152820|NCT02904954|141797884|SUPERIORITY||Risk Difference (RD)|46.6||||0.0001|TWO_SIDED|95.0|26.7|66.6||Testing at alpha = 0.05.|Fisher Exact|||Fisher's exact test performed to compare the MPR proportion between the two treatment arms. Null hypothesis is that there is no difference in the MPR proportion between the two arms.||66.6|26.7|0.0001
70969770|NCT01399788|141445111|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|105.74|||||TWO_SIDED|90.0|100.32|111.46||||||Isoniazid; Natural log transformed AUC(0-∞) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||111.46|100.32|
71152821|NCT02904954|141797885|SUPERIORITY|||||||0.89|||||||Log Rank|||Kaplan-Meier survival analysis comparing the two arms.||||0.89
71152822|NCT02904954|141797886|SUPERIORITY||Risk Difference (RD)|43.4||||0.0001|TWO_SIDED|95.0|24.4|62.3||Testing at alpha = 0.05.|Fisher Exact|||Fisher's exact test performed to compare the objective clinical response proportion between the two treatment arms. Null hypothesis is that there is no difference in the objective clinical response proportion between the two arms. Objective clinical response proportion is defined as the proportion of patients in each arm who have complete response or partial response.||62.3|24.4|0.0001
71152823|NCT00337675|141797890|SUPERIORITY_OR_OTHER_LEGACY||Rate reduction|5.3|STANDARD_ERROR_OF_MEAN|7.3||0.51||95.0|-11.4|19.6||Multiplicity adjustment across regimens was addressed through step-down testing. Daily montelukast versus placebo was tested first; if this comparison was significant, intermittent montelukast versus placebo was tested. The significance level was 5%.|Regression, Poisson|A Poisson regression model containing factors for treatment, age group, and geographic region, and an offset for number of days in study was used.|Rate reduction = (1 - montelukast-adjusted annual rate/placebo-adjusted annual rate) x 100%|The primary hypothesis stated that montelukast (daily regimen, or \[intermittent and daily regimens\]), compared with placebo, results in a decrease in the number of asthma episodes culminating in asthma attack in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year. A sample size of 450 evaluable patients per arm allowed the detection of a difference in rate of 23% with 90% power.||19.6|-11.4|0.510
71152824|NCT00337675|141797890|SUPERIORITY_OR_OTHER_LEGACY||Rate reduction|-1.2|STANDARD_ERROR_OF_MEAN|7.8||0.884||95.0|-19.2|14.0||Multiplicity adjustment across regimens was addressed through step-down testing. Daily montelukast versus placebo was tested first; if this comparison was significant, intermittent montelukast versus placebo was tested. The significance level was 5%.|Regression, Poisson|A Poisson regression model containing factors for treatment, age group, and geographic region, and an offset for number of days in study was used.|Rate reduction = (1 - montelukast-adjusted annual rate/placebo-adjusted annual rate) x 100%|The primary hypothesis stated that montelukast (daily regimen, or \[intermittent and daily regimens\]), compared with placebo, results in a decrease in the number of asthma episodes culminating in asthma attack in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year. A sample size of 450 evaluable patients per arm allowed the detection of a difference in rate of 23% with 90% power.||14.0|-19.2|0.884
71152825|NCT00337675|141797891|SUPERIORITY_OR_OTHER_LEGACY||Least-Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.14||0.176||95.0|-0.46|0.09||Multiplicity adjustment across regimens and across primary and secondary endpoints was addressed through step-down testing. Within the 2 endpoints assessing severity, adjustment for multiplicity was performed using Hochberg's method.|ANOVA|An ANOVA model containing factors for treatment, age group, and geographical region was used.||The secondary hypothesis stated that montelukast (daily regimen, or \[intermittent and daily regimens\]), compared with placebo, results in improvement of respiratory symptoms assessed over 3 days prior to asthma attacks, or assessed over the 12-day treatment period of asthma episodes in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year.||0.09|-0.46|0.176
71152826|NCT00337675|141797891|SUPERIORITY_OR_OTHER_LEGACY||Least-Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.202||95.0|-0.44|0.09||Multiplicity adjustment across regimens and across primary and secondary endpoints was addressed through step-down testing. Within the 2 endpoints assessing severity, adjustment for multiplicity was performed using Hochberg's method.|ANOVA|An ANOVA model containing factors for treatment, age group, and geographical region was used.||The secondary hypothesis stated that montelukast (daily regimen, or \[intermittent and daily regimens\]), compared with placebo, results in improvement of respiratory symptoms assessed over 3 days prior to asthma attacks, or assessed over the 12-day treatment period of asthma episodes in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year.||0.09|-0.44|0.202
71152827|NCT00337675|141797892|SUPERIORITY_OR_OTHER_LEGACY||Least-Squares Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.06||0.045||95.0|-0.24|0.0||Multiplicity adjustment across regimens and across primary and secondary endpoints was addressed through step-down testing. Within the family of secondary endpoints, adjustment for multiplicity was performed using Hochberg's method.|ANOVA|An ANOVA model containing factors for treatment, age group, and geographical region was used.||The secondary hypothesis stated that montelukast (daily regimen, or \[intermittent and daily regimens\]), compared with placebo, results in improvement of respiratory symptoms assessed over 3 days prior to asthma attacks, or assessed over the 12-day treatment period of asthma episodes in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year.||0.00|-0.24|0.045
71091966|NCT01126424|141690518|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-20.986||||0.3771|TWO_SIDED|95.0|-68.58|26.607|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||26.607|-68.580|0.3771
70969771|NCT01399788|141445111|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|100.97|||||TWO_SIDED|90.0|96.28|105.88||||||Ethambutol; Natural log transformed AUC(0-∞) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||105.88|96.28|
71152828|NCT00337675|141797892|SUPERIORITY_OR_OTHER_LEGACY||Least-Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.061||95.0|-0.23|0.0||Multiplicity adjustment across regimens and across primary and secondary endpoints was addressed through step-down testing. Within the family of secondary endpoints, adjustment for multiplicity was performed using Hochberg's method.|ANOVA|An ANOVA model containing factors for treatment, age group, and geographical region was used.||The secondary hypothesis stated that montelukast (daily regimen, or \[intermittent and daily regimens\]), compared with placebo, results in improvement of respiratory symptoms assessed over 3 days prior to asthma attacks, or assessed over the 12-day treatment period of asthma episodes in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year.||0.00|-0.23|0.061
71152829|NCT01317277|141797902|SUPERIORITY|||||||0.68||||||In between-group analyses, overall MEMS adherence was defined as % of doses taken.|Wilcoxon (Mann-Whitney)|Non-parametric methods.||Randomization strategy for target 75 participants of 2:1 \[iTAB(n=50):CTRL(n=25)\], resulting in 80% power to detect effect size of .71 for difference of adherence rates between groups (Wilcoxon-Mann-Whitney critical t=1.99, df=69.6). Final # analyzed: iTAB (n=43) \& CTRL (n=23).||||0.68
71152830|NCT01317277|141797903|SUPERIORITY|||||||0.95||||||MEMS adherence based on dose timing was examined for between-group differences.|Wilcoxon (Mann-Whitney)|Non-parametric methods||Randomization strategy for target 75 participants of 2:1 \[iTAB(n=50):CTRL(n=25)\], resulting in 80% power to detect effect size of .71 for difference of adherence rates between groups (Wilcoxon-Mann-Whitney critical t=1.99, df=69.6). Final # analyzed: iTAB (n=43) \& CTRL (n=23).||||0.95
71152831|NCT01317277|141797904|SUPERIORITY|||||||0.05||||||Z = -1.97|Wilcoxon (Mann-Whitney)|Non-parametric methods; P-Value is calculated.||Text-reported METH use days||||0.05
71152832|NCT00912795|141797912|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.0|||||TWO_SIDED|95.0|0.62|6.3||||||||6.3|0.62|
71152833|NCT00912795|141797913|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3|||||TWO_SIDED|95.0|0.5|3.2||||||||3.2|0.50|
71152834|NCT00912795|141797914|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.5|||||TWO_SIDED|95.0|0.81|7.5||||||||7.5|0.81|
71152835|NCT00912795|141797915|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.0|||||TWO_SIDED|95.0|0.62|6.3||||||||6.3|.62|
71152836|NCT01075685|141797916|SUPERIORITY_OR_OTHER|||||||0.0279||95.0|||||Type 3 tests of fixed effects|||||||0.0279
71152837|NCT01075685|141797917|SUPERIORITY_OR_OTHER|||||||0.0189||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0189
71152838|NCT01075685|141797918|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Chi-squared|||||||0.009
71152839|NCT01075685|141797919|SUPERIORITY_OR_OTHER|||||||0.082||95.0|||||Chi-squared|||||||0.082
71152840|NCT02858362|141797926|OTHER|Difference in least square means. All 23 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|0.023|||||TWO_SIDED|95.0|-0.002|0.048||||||Week 24 Change from Baseline||0.048|-0.002|
71152841|NCT02858362|141797926|OTHER|Difference in least square means. All 16 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|0.006|||||TWO_SIDED|95.0|-0.03|0.042||||||Week 48 Change from Baseline||0.042|-0.03|
71152842|NCT02858362|141797927|OTHER|Difference in least square means. All 24 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|-2.611|||||TWO_SIDED|95.0|-4.324|-0.898||||||Week 24 Change from Baseline||-0.898|-4.324|
71152843|NCT02858362|141797927|OTHER|Difference in least square means. All 16 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|1.166|||||TWO_SIDED|95.0|-1.103|3.435||||||Week 48 Change from Baseline||3.435|-1.103|
71152844|NCT02858362|141797928|OTHER|Difference in least square means. All 24 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|-1.837|||||TWO_SIDED|95.0|-3.989|0.315||||||Week 24 Change from Baseline||0.315|-3.989|
71152845|NCT02858362|141797928|OTHER|Difference in least square means. All 16 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|2.21|||||TWO_SIDED|95.0|0.096|4.324||||||Week 48 Change from Baseline||4.324|0.096|
71152846|NCT01262989|141797945|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|102.95||||||90.0|97.17|109.07|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||109.07|97.17|
71152847|NCT01262989|141797946|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|102.79||||||90.0|96.99|108.93|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||108.93|96.99|
71152848|NCT01262989|141797947|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|94.47||||||90.0|87.59|101.9|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||101.90|87.59|
71152849|NCT01243580|141797992|EQUIVALENCE|Comparing Ortho-Cyclen to Ag200-15|||||<|0.0001|||||||ANOVA|||||||<0.0001
71152850|NCT01243580|141797993|EQUIVALENCE|Comparison of AG200-15 and Ortho-Cyclen|||||<|0.0001|||||||ANOVA|||||||<0.0001
71152851|NCT01243580|141797994|EQUIVALENCE|Comparison of AG200-15 and Ortho-Cyclen||||||0.0001|||||||ANOVA|||||||0.0001
71152852|NCT01243580|141797995|EQUIVALENCE|Comparison of Ortho-Cylen and AG200-15||||||0.0532|||||||ANOVA|||||||0.0532
71152853|NCT01243580|141797996|EQUIVALENCE|Comparison of Ortho-Cyclen and AG200-15||||||0.0009|||||||ANOVA|||||||0.0009
71152854|NCT01243580|141797997|EQUIVALENCE|Comparison of Ortho-Cyclen and AG200-15||||||0.0167|||||||ANOVA|||||||0.0167
71152855|NCT01243580|141797998|EQUIVALENCE|Comparison of Ortho-Cyclen and AG200-15||||||0.0007|||||||ANOVA|||||||0.0007
71152856|NCT01243580|141797999|EQUIVALENCE|Comparison of Ortho-Cyclen and AG200-15||||||0.0175|||||||ANOVA|||||||0.0175
71152857|NCT01243580|141798000|EQUIVALENCE|Comparison of Ortho-Cyclen and AG200-15||||||0.0001|||||||ANOVA|||||||0.0001
71152858|NCT01243580|141798001|EQUIVALENCE|Comparison of Ortho-Cyclen and AG200-15||||||0.0532|||||||ANOVA|||||||0.0532
71152859|NCT02100696|141798024|SUPERIORITY||Adjusted difference in response rates|12.2||||0.0033|TWO_SIDED|95.0|3.95|17.67|||Cochran-Mantel-Haenszel|||||17.67|3.95|0.0033
71152860|NCT02100696|141798025|SUPERIORITY||Treatment Difference|3.8||||0.4956|TWO_SIDED|95.0|-7.13|14.56|||Cochran-Mantel-Haenszel|||||14.56|-7.13|0.4956
71152861|NCT02100696|141798026|SUPERIORITY||Adjusted Difference in Remission Rates|12.5||||0.0028|TWO_SIDED|95.0|4.19|17.94||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||17.94|4.19|0.0028
71152862|NCT02100696|141798027|SUPERIORITY||Adjusted Difference in Response Rates|14.3||||0.0241|TWO_SIDED|95.0|3.21|24.14||Multiplicity P-value reported (adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||24.14|3.21|0.0241
71152863|NCT02100696|141798028|SUPERIORITY||Adjusted Difference in Response Rates|8.1||||0.1605|TWO_SIDED|95.0|-2.54|17.22||Multiplicity P-value reported (adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||17.22|-2.54|0.1605
71152864|NCT02100696|141798029|SUPERIORITY||Adjusted Difference in Remission Rates|7.6||||0.3881|TWO_SIDED|95.0|-1.22|13.66||Multiplicity P-value reported (adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||13.66|-1.22|0.3881
71152865|NCT02100696|141798030|SUPERIORITY||Adjusted Difference in Remission Rates|4.9||||0.5879|TWO_SIDED|95.0|-6.78|14.69||Multiplicity P-value reported (adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||14.69|-6.78|0.5879
71152866|NCT02100696|141798031|SUPERIORITY||Difference in Unadjusted Means|-0.2||||0.0351|TWO_SIDED|95.0|-0.5|0.0||Multiplicity P-value reported (adjusted for multiplicity)|ANCOVA|||||-0.0|-0.5|0.0351
71152867|NCT02100696|141798032|SUPERIORITY||Difference in Unadjusted Means|-0.2||||0.2698|TWO_SIDED|95.0|-0.4|0.1||Multiplicity P-value reported (adjusted for multiplicity)|ANCOVA|||||0.1|-0.4|0.2698
71152868|NCT02100696|141798033|SUPERIORITY||Difference in Least Square Means|-1.6||||0.2698|TWO_SIDED|95.0|-2.9|-0.3||Multiplicity P-value reported (adjusted for multiplicity)|Mixed Models Analysis|||||-0.3|-2.9|0.2698
71152869|NCT02100696|141798034|SUPERIORITY||Difference in Least Square Means|-0.5||||0.3881|TWO_SIDED|95.0|-1.0|0.0||Multiplicity P-value reported (adjusted for multiplicity)|Mixed Models Analysis|||||0.0|-1.0|0.3881
71152870|NCT02100696|141798035|SUPERIORITY||Difference in Adjusted Means|9.1||||0.0445|TWO_SIDED|95.0|0.2|17.9||Nominal P-value reported (not adjusted for multiplicity)|ANCOVA|||||17.9|0.2|0.0445
71152871|NCT02100696|141798036|SUPERIORITY||Adjusted Difference in Remission Rates|0.1||||0.9959|TWO_SIDED|95.0|-19.67|19.88||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||19.88|-19.67|0.9959
71152872|NCT02100696|141798037|SUPERIORITY||Adjusted Difference in Remission Rates|3.8||||0.5014|TWO_SIDED|95.0|-7.26|14.7||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||14.70|-7.26|0.5014
71152873|NCT02100696|141798038|SUPERIORITY||Adjusted Difference in Remission Rates|0.6||||0.9538|TWO_SIDED|95.0|-19.08|20.35||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||20.35|-19.08|0.9538
71152874|NCT02100696|141798039|SUPERIORITY||Adjusted Difference in Response Rates|14.5||||0.0153|TWO_SIDED|95.0|2.66|25.78||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||25.78|2.66|0.0153
71152875|NCT02100696|141798040|SUPERIORITY||Adjusted Difference in Remission Rates|16.8||||0.0073|TWO_SIDED|95.0|4.44|28.41||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||28.41|4.44|0.0073
71152876|NCT02100696|141798041|SUPERIORITY||Adjusted Difference in Remission Rates|11.9||||0.0174|TWO_SIDED|95.0|1.87|21.71||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||21.71|1.87|0.0174
71152877|NCT02100696|141798042|SUPERIORITY||Adjusted Difference in Remission Rates|7.3||||0.3015|TWO_SIDED|95.0|-6.83|21.6||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||21.60|-6.83|0.3015
71152878|NCT02100696|141798043|SUPERIORITY||Adjusted Difference in Remission Rates|7.4||||0.2787|TWO_SIDED|95.0|-6.23|21.17||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||21.17|-6.23|0.2787
71152879|NCT02100696|141798044|SUPERIORITY||Difference in Least Square Means|-1.5||||0.0763|TWO_SIDED|95.0|-3.1|0.2||Nominal P-value reported (not adjusted for multiplicity)|Mixed Models Analysis|||||0.2|-3.1|0.0763
71152880|NCT02100696|141798045|SUPERIORITY||Difference in Least Square Means|-0.2||||0.5329|TWO_SIDED|95.0|-1.0|0.5||Nominal P-value reported (not adjusted for multiplicity)|Mixed Models Analysis|||||0.5|-1.0|0.5329
71152881|NCT02100696|141798046|SUPERIORITY||Difference in Adjusted Means|-4.9||||0.2228|TWO_SIDED|95.0|-12.7|3.0||Nominal P-value reported (not adjusted for multiplicity)|ANCOVA|||||3.0|-12.7|0.2228
71152882|NCT00078897|141798058|OTHER|Negative binomial regression|Risk Ratio (RR)|1.03||||0.68|TWO_SIDED|95.0|0.91|1.16|||Negative binomial regression|||||1.16|0.91|0.68
71152883|NCT00048074|141798083|NON_INFERIORITY_OR_EQUIVALENCE|The IV dosing regimen (2mg q 2 mo IV) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to -1 percentage point.|Mean Difference (Final Values)|1.257|||<|0.001|TWO_SIDED|95.0|0.701|1.814|||ANOVA||Treatment effect is the difference in the mean values of the IV regimen (2mg q 2 mo IV) and the active-control.|The primary hypothesis was that the difference in the effects of daily oral ibandronate and IV ibandronate (2mg q 2 mo IV) on the relative change in lumbar spine BMD (L2 - L4) was small, no more than 1%, the margin of clinical equivalence.||1.814|0.701|<0.001
71152884|NCT00048074|141798083|NON_INFERIORITY_OR_EQUIVALENCE|The IV dosing regimen (3mg q 3 mo IV) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to -1 percentage point.|Mean Difference (Final Values)|1.025|||<|0.001|TWO_SIDED|95.0|0.471|1.578|||ANOVA||Treatment effect is the difference in the mean values of the IV regimen (3mg q 3 mo IV) and the active-control.|The primary hypothesis was that the difference in the effects of daily oral ibandronate and IV ibandronate (3mg q 3 mo IV) on the relative change in lumbar spine BMD (L2 - L4) was small, no more than 1%, the margin of clinical equivalence.||1.578|0.471|<0.001
71152885|NCT00740857|141798136|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Proportional hazards model|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||<0.001
71152886|NCT00740857|141798136|SUPERIORITY_OR_OTHER|||||||0.001|||||||Proportional hazards model|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||0.001
71152887|NCT00740857|141798136|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Proportional hazards model|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||<0.001
71152888|NCT00740857|141798137|SUPERIORITY_OR_OTHER|||||||0.118|||||||ANOVA|With treatment, baseline Pain Severity Rating (PSR), and gender terms.||15 minutes||||0.118
71152889|NCT00740857|141798137|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|With treatment, baseline Pain Severity Rating (PSR), and gender terms.||The 30, 45, 60....||||<0.001
71152890|NCT00740857|141798138|SUPERIORITY_OR_OTHER|||||||0.041|||||||ANOVA|With treatment, baseline Pain Severity Rating (PSR), and gender terms.||15 minutes||||0.041
71152891|NCT00740857|141798138|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|With treatment, baseline Pain Severity Rating (PSR), and gender terms.||The 30, 45, 60, 90, 120, 180, 240, 300 and 360 minute individual time points all have the same P-value score.||||<0.001
71152892|NCT00740857|141798139|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|With treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||<0.001
71152893|NCT00740857|141798140|SUPERIORITY_OR_OTHER|||||||0.056|||||||ANOVA|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||15 minutes||||0.056
71152894|NCT00740857|141798140|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||The 30, 45, 60, 90, 120, 180, 240, 300 and 360 minute individual time points all have the same P-value score.||||<0.001
71152895|NCT00740857|141798141|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||<0.001
71152896|NCT00740857|141798142|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||<0.001
71152897|NCT00740857|141798143|SUPERIORITY_OR_OTHER||||||<|0.001|||||||proportional hazards model|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||<0.001
71152898|NCT03532451|141798150|SUPERIORITY|||||||0.08|||||||Wilcoxon Signed-Rank Test|||Null hypothesis is the change in CD8+ cell density is not significantly different from zero.||||0.08
71152899|NCT03532451|141798150|SUPERIORITY|||||||0.002|||||||Wilcoxon Signed-Rank Test|||||||0.002
71152900|NCT03532451|141798151|SUPERIORITY|||||||0.88|||||||Wilcoxon rank sum test|||||||0.88
71152901|NCT02654769|141798162|EQUIVALENCE|Difference (Generic- Picato)|90% Wald's confidence interval|-1.87|||<|0.0001|TWO_SIDED|90.0|-12.37|8.63|||Fisher Exact|||||8.63|-12.37|<0.0001
71152902|NCT02654769|141798163|EQUIVALENCE|Difference (Generic - Picato)|90% Wald's confidence interval|-2.64|||<|0.0001|TWO_SIDED|90.0|-13.14|7.86|||Fisher Exact|||Partial Clearance at Week 8||7.86|-13.14|<0.0001
71152903|NCT00233064|141798198|SUPERIORITY_OR_OTHER||Overall percentage of immune reactivity|0.0||||||95.0|0.0|1.9|||||The number and percentage of subjects with immune reactivity at Study Day 240-300 were constructed using the Clopper-Pearson Method.|The subject number of 200 per treatment group was derived to demonstrate a percentage of immune reactivity in either the liquid or lyophilized formulations of palivizumab of \<2-3% based on 95% confidence intervals \[(0%; 0.00, 1.83), (0.5%; 0.01, 2.75), (1%; 0.12, 3.57)\].||1.9|0.0|
71152904|NCT00233064|141798198|SUPERIORITY_OR_OTHER||Overall percentage of immune reactivity|0.5||||||95.0|0.0|2.9|||||The number and percentage of subjects with immune reactivity at Study Day 240-300 were constructed using the Clopper-Pearson Method.|The subject number of 200 per treatment group was derived to demonstrate a percentage of immune reactivity in either the liquid or lyophilized formulations of palivizumab of \<2-3% based on 95% confidence intervals \[(0%; 0.00, 1.83), (0.5%; 0.01, 2.75), (1%; 0.12, 3.57)\].||2.9|0.0|
71152905|NCT00233064|141798198|SUPERIORITY_OR_OTHER||Overall percentage of immune reactivity|0.3||||||95.0|0.0|1.5|||||The number and percentage of subjects with immune reactivity at Study Day 240-300 were constructed using the Clopper-Pearson Method.|The subject number of 200 per treatment group was derived to demonstrate a percentage of immune reactivity in either the liquid or lyophilized formulations of palivizumab of \<2-3% based on 95% confidence intervals \[(0%; 0.00, 1.83), (0.5%; 0.01, 2.75), (1%; 0.12, 3.57)\].||1.5|0.0|
71152906|NCT03508908|141798203|OTHER||US dollars per DALY averted|3098.0|||||TWO_SIDED||||||||Cost (in US dollars) per DALY averted (Intervention referenced to Observation)|Cost (in US dollars) per DALY averted (Intervention referenced to Observation)||||
71152907|NCT01120964|141798222|OTHER|Analyses presented herein are for re-intubation time included.|Mean Difference (Final Values)|32.0||||0.0222|TWO_SIDED|95.0|-9.5|73.4||The threshold for statistical significance was p\<0.05|Wilcoxon (Mann-Whitney)|||"Total duration of postoperative invasive mechanical ventilation was analyzed by treatment group using summary statistics, and was compared between citrulline and placebo groups using an ANOVA.~Kaplan-Meier analyses were performed for: 1) zero durations censored, 2) zero durations uncensored, 3) patients with zero duration excluded. The same analyses were performed with re-intubation time removed."||73.4|-9.5|0.0222
71152908|NCT01120964|141798223|OTHER||Mean Difference (Final Values)|32.0||||0.0222|TWO_SIDED|95.0|-9.5|73.4||Re-intubation time included. Threshold for significance was p\<0.05|t-test, 2 sided|||Analyses presented herein are for re-intubation time included.||73.4|-9.5|0.0222
71152909|NCT01120964|141798224|OTHER||Mean Difference (Final Values)|50.7||||0.0418|TWO_SIDED|95.0|5.4|96.0||The threshold for significance was P\<0.05|Wilcoxon (Mann-Whitney)|||||96.0|5.4|0.0418
71152910|NCT01120964|141798225|OTHER||Mean Difference (Final Values)|12.7||||0.0727|TWO_SIDED|95.0|-2.6|28.1||The threshold for significance was p\<0.05|Wilcoxon (Mann-Whitney)|||||28.1|-2.6|0.0727
71152911|NCT01120964|141798226|OTHER||Mean Difference (Final Values)|559.8||||0.1271|TWO_SIDED|95.0|-193.5|1313.2|||Wilcoxon (Mann-Whitney)|||||1313.2|-193.5|0.1271
71152912|NCT01120964|141798227|OTHER||Mean Difference (Final Values)|3.5||||0.972|TWO_SIDED|95.0|-7.0|14.1|||Wilcoxon (Mann-Whitney)|||||14.1|-7.0|0.9720
71152913|NCT01120964|141798228|OTHER||Mean Difference (Final Values)|5.2||||0.8884|TWO_SIDED|95.0|-7.7|18.0|||Wilcoxon (Mann-Whitney)|||||18.0|-7.7|0.8884
71152914|NCT01120964|141798229|OTHER|Total number of postoperative hours spent in PICU|Mean Difference (Final Values)|69.14||||0.1891|TWO_SIDED|95.0|-49.39|187.67||The threshold for significance was p\<0.05|Wilcoxon (Mann-Whitney)|||||187.67|-49.39|0.1891
71152915|NCT01120964|141798230|OTHER||Mean Difference (Final Values)|30.2||||0.0479|TWO_SIDED|95.0|-10.8|71.1||Duration including re-intubation time. Threshold for significance was p\<0.05|Wilcoxon (Mann-Whitney)|||||71.1|-10.8|0.0479
71152916|NCT01120964|141798231|OTHER||Mean Difference (Final Values)|3.7||||0.2637|TWO_SIDED|95.0|-2.2|9.7|||Wilcoxon (Mann-Whitney)|||||9.7|-2.2|0.2637
71152917|NCT01120964|141798233|OTHER||Mean Difference (Final Values)|7.5||||0.6431|TWO_SIDED|95.0|-25.9|41.0|||t-test, 2 sided|||||41.0|-25.9|0.6431
71152918|NCT01120964|141798234|OTHER||Mean Difference (Final Values)|39.5||||0.6408|TWO_SIDED|95.0|-134.2|213.1|||ANOVA|||||213.1|-134.2|0.6408
71152919|NCT00826202|141798246|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Mixed Models Analysis|cohen's d= 0.67||||||0.07
71152920|NCT00826202|141798247|SUPERIORITY_OR_OTHER|||||||0.056|TWO_SIDED||||||t-test, 2 sided|cohen's d=0.84||||||.056
71152921|NCT00826202|141798248|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Mixed Models Analysis|Cohen's d=0.68||||||0.03
71152922|NCT00826202|141798249|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Mixed Models Analysis|cohen's d=0.93||||||0.12
71152923|NCT00829504|141798253|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.16||||||90.0|95.5|105.04|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||105.04|95.5|
71152924|NCT00829504|141798254|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.76||||||90.0|95.45|108.49|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.49|95.45|
71152925|NCT00829504|141798255|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.1||||||90.0|95.64|109.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||109|95.64|
71152926|NCT05307692|141798265|SUPERIORITY||Difference of Least Square (LS) Means|-1.5|STANDARD_ERROR_OF_MEAN|1.47||0.308|TWO_SIDED|80.0|-3.41|0.39|||Mixed model repeated measures|||||0.39|-3.41|0.308
71152927|NCT05307692|141798266|SUPERIORITY||Difference of Least Square (LS) Means|-1.5|STANDARD_ERROR_OF_MEAN|1.42||0.282|TWO_SIDED|80.0|-3.33|0.29|||Mixed model repeated measures|||||0.29|-3.33|0.282
71152928|NCT05407064|141798270|SUPERIORITY|Mean change from baseline and mean difference between MM120 dose groups and placebo were estimated using model averaging method (of 3 models). The minimally efficacious dose was defined as a placebo-adjusted improvement of 2.5 points on the HAM-A, with a statistical significance set at an alpha level of 0.05.||||||||||||||||The primary endpoint was evaluated by determining if there was a dose-response relationship between the change from baseline to Week 4 in total HAM-A score and the dose administered using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed, and multiple comparison techniques were used to choose the model(s) likely to present the true underlying dose-response curve.|A test statistic was derived from the data using an ANCOVA model with change from Baseline to Week 4 for the HAM-A Total Score as a response variable, treatment arm and Baseline value of HAM-A Total Score as covariates. The ANCOVA model was repeated for each imputed dataset, which resulted in a set of LS mean estimates for all dose groups and the related covariance matrices. Rubin's rule was used to combine the multiple sets of LS mean estimates and the related covariance matrices to a single set of LS mean estimates of change from Baseline to Week 4 for HAM-A Total Score for all dose groups and the related covariance matrix. The SAS procedure PROC MIANALYZE was used to combine the results from imputed datasets.|||
71152929|NCT05407064|141798271|SUPERIORITY|Mean change from baseline and mean difference between MM120 dose groups and placebo were estimated using model averaging method (of 3 models). The minimally efficacious dose was defined as a placebo-adjusted improvement of 2.5 points on the HAM-A, with a statistical significance set at an alpha level of 0.05.||||||||||||||||The primary endpoint was evaluated by determining if there was a dose-response relationship between the change from baseline to Week 8 in total HAM-A score and the dose administered using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed, and multiple comparison techniques were used to choose the model(s) likely to present the true underlying dose-response curve.|A test statistic was derived from the data using an ANCOVA model with change from Baseline to Week 8 for the HAM-A Total Score as a response variable, treatment arm and Baseline value of HAM-A Total Score as covariates. The ANCOVA model was repeated for each imputed dataset, which resulted in a set of LS mean estimates for all dose groups and the related covariance matrices. Rubin's rule was used to combine the multiple sets of LS mean estimates and the related covariance matrices to a single set of LS mean estimates of change from Baseline to Week 8 for HAM-A Total Score for all dose groups and the related covariance matrix. The SAS procedure PROC MIANALYZE was used to combine the results from imputed datasets.|||
71152930|NCT05407064|141798272|SUPERIORITY|||||||0.1157|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.1157
71152931|NCT05407064|141798272|SUPERIORITY|||||||0.663|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.6630
71152932|NCT05407064|141798272|SUPERIORITY|||||||0.0004|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.0004
71152933|NCT05407064|141798272|SUPERIORITY|||||||0.01|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.0100
71152934|NCT05407064|141798273|SUPERIORITY|||||||0.2309|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.2309
71152935|NCT05407064|141798273|SUPERIORITY|||||||0.7218|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.7218
71152936|NCT05407064|141798273|SUPERIORITY|||||||0.0637|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.0637
71152937|NCT05407064|141798273|SUPERIORITY|||||||0.0216|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.0216
71152938|NCT05407064|141798274|SUPERIORITY|||||||0.1006|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.1006
71152939|NCT05407064|141798274|SUPERIORITY|||||||0.2225|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.2225
70969772|NCT01399788|141445112|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|101.8|||||TWO_SIDED|90.0|99.24|104.43||||||Pyrazinamide; Natural log transformed AUC (0 -∞)(dn) was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||104.43|99.24|
71152940|NCT05407064|141798274|SUPERIORITY|||||||0.0025|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.0025
71152941|NCT05407064|141798274|SUPERIORITY|||||||0.0042|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.0042
71152942|NCT05407064|141798275|SUPERIORITY|||||||0.6258|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.6258
71152943|NCT05407064|141798275|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.95
70969773|NCT02919436|141445115|SUPERIORITY|We found observed rate of postoperative urinary retention in male spine surgery patients to historically be 17%. We hypothesize that the use of tamsulosin can reduce this rate by 50%. A two group continuity corrected chi-square test with a .05 two-sided significance level will have 80% power to detect the difference between a control group proportion of .17 and a treatment group proportion of .085 (odds ratio of .454) when the sample size in each group is 264 and a total sample size of 528.||||||0.96|||||||Chi-squared, Corrected|||||||.96
70969774|NCT03699007|141445119|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71152944|NCT05407064|141798275|SUPERIORITY|||||||0.0174|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.0174
71152945|NCT05407064|141798275|SUPERIORITY|||||||0.0206|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.0206
71152946|NCT05407064|141798276|SUPERIORITY|||||||0.5538|||||||t-test, 2 sided|||Assessment of change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.5538
71152947|NCT05407064|141798276|SUPERIORITY|||||||0.665|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.6650
71152948|NCT05407064|141798276|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.0190
71152949|NCT05407064|141798276|SUPERIORITY|||||||0.0034|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.0034
71152950|NCT05407064|141798277|SUPERIORITY|||||||0.7236|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.7236
70969775|NCT03699007|141445120|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
70969776|NCT03259074|141445126|SUPERIORITY||Marginal difference|1.51||||0.7164|TWO_SIDED|95.0|-6.63|9.64||Logistic regression model with treatment as a factor and baseline mSASSS score as a covariate using marginal standardization method.|Regression, Logistic|||||9.64|-6.63|0.7164
70969777|NCT03259074|141445126|SUPERIORITY||Marginal difference|1.67||||0.6925|TWO_SIDED|95.0|-6.61|9.95|||Regression, Logistic|Logistic regression model with treatment as a factor and baseline mSASSS score as a covariate using marginal standardization method.||||9.95|-6.61|0.6925
70969778|NCT03259074|141445127|SUPERIORITY|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|LS mean difference|-0.18|||||TWO_SIDED|95.0|-0.646|0.293|||||ANCOVA model with treatment as a factor and baseline mSASSS score as a covariate.|||0.293|-0.646|
71152951|NCT05407064|141798277|SUPERIORITY|||||||0.9738|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.9738
71152952|NCT05407064|141798277|SUPERIORITY|||||||0.0338|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.0338
71152953|NCT05407064|141798277|SUPERIORITY|||||||0.0282|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.0282
71152954|NCT05407064|141798278|SUPERIORITY|||||||0.9302|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.9302
71152955|NCT05407064|141798278|SUPERIORITY|||||||0.6763|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.6763
71152956|NCT05407064|141798278|SUPERIORITY|||||||0.0816|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0816
71152957|NCT05407064|141798278|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0190
71152958|NCT05407064|141798279|SUPERIORITY|||||||0.5647|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.5647
71152959|NCT05407064|141798279|SUPERIORITY|||||||0.3497|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.3497
71152960|NCT05407064|141798279|SUPERIORITY|||||||0.0229|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0229
71152961|NCT05407064|141798279|SUPERIORITY|||||||0.0073|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0073
71152962|NCT05407064|141798280|SUPERIORITY|||||||0.0158|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0158
71152963|NCT05407064|141798280|SUPERIORITY|||||||0.0429|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0429
71152964|NCT05407064|141798280|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0001
71152965|NCT05407064|141798280|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0000
71152966|NCT05407064|141798281|SUPERIORITY|||||||0.0804|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0804
71152967|NCT05407064|141798281|SUPERIORITY|||||||0.0532|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0532
71152968|NCT05407064|141798281|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0001
71152969|NCT05407064|141798281|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0000
71152970|NCT05407064|141798282|SUPERIORITY|||||||0.2152|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.2152
71152971|NCT05407064|141798282|SUPERIORITY|||||||0.3369|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.3369
71152972|NCT05407064|141798282|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0010
71152973|NCT05407064|141798282|SUPERIORITY|||||||0.0046|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0046
71152974|NCT05407064|141798283|SUPERIORITY|||||||0.4489|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.4489
71152975|NCT05407064|141798283|SUPERIORITY|||||||0.7326|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.7326
71152976|NCT05407064|141798283|SUPERIORITY|||||||0.0492|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0492
71152977|NCT05407064|141798283|SUPERIORITY|||||||0.0131|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0131
71152978|NCT05407064|141798284|SUPERIORITY|||||||0.333|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.3330
71152979|NCT05407064|141798284|SUPERIORITY|||||||0.1193|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.1193
71152980|NCT05407064|141798284|SUPERIORITY|||||||0.0032|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0032
71152981|NCT05407064|141798284|SUPERIORITY|||||||0.0127|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0127
71152982|NCT05407064|141798285|SUPERIORITY|||||||0.0046|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0046
71152983|NCT05407064|141798285|SUPERIORITY|||||||0.0052|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0052
71152984|NCT05407064|141798285|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0000
71152985|NCT05407064|141798285|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0000
71152986|NCT05407064|141798286|SUPERIORITY|||||||0.0567|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0567
71152987|NCT05407064|141798286|SUPERIORITY|||||||0.0235|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0235
71152988|NCT05407064|141798286|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0000
71152989|NCT05407064|141798286|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0000
71152990|NCT05407064|141798287|SUPERIORITY|||||||0.2632|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.2632
71152991|NCT05407064|141798287|SUPERIORITY|||||||0.2962|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.2962
71152992|NCT05407064|141798287|SUPERIORITY|||||||0.0013|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0013
71152993|NCT05407064|141798287|SUPERIORITY|||||||0.0547|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0547
71152994|NCT05407064|141798288|SUPERIORITY|||||||0.0937|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0937
71152995|NCT05407064|141798288|SUPERIORITY|||||||0.823|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.8230
71152996|NCT05407064|141798288|SUPERIORITY|||||||0.0032|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0032
71152997|NCT05407064|141798288|SUPERIORITY|||||||0.0129|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0129
71152998|NCT05407064|141798289|SUPERIORITY|||||||0.1889|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1889
71152999|NCT05407064|141798289|SUPERIORITY|||||||0.1589|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1589
71153000|NCT05407064|141798289|SUPERIORITY|||||||0.0008|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0008
71153001|NCT05407064|141798289|SUPERIORITY|||||||0.0194|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0194
71153002|NCT05407064|141798290|SUPERIORITY|||||||0.0057|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0057
71153003|NCT05407064|141798290|SUPERIORITY|||||||0.0168|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0168
71153004|NCT05407064|141798290|SUPERIORITY|||||||0|||||||t-test, 2 sided|||||||0.0000
71153005|NCT05407064|141798290|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0000
71153006|NCT05407064|141798291|SUPERIORITY|||||||0.0958|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0958
71153007|NCT05407064|141798291|SUPERIORITY|||||||0.0544|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0544
71153008|NCT05407064|141798291|SUPERIORITY|||||||0.0029|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0029
71153009|NCT05407064|141798291|SUPERIORITY|||||||0.0006|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0006
71153010|NCT05407064|141798292|SUPERIORITY|||||||0.2038|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test)||||0.2038
71153011|NCT05407064|141798292|SUPERIORITY|||||||0.1977|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test)||||0.1977
71153012|NCT05407064|141798292|SUPERIORITY|||||||0.0357|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test)||||0.0357
71153013|NCT05407064|141798292|SUPERIORITY|||||||0.0302|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test)||||0.0302
71153014|NCT05407064|141798293|SUPERIORITY|||||||0.2165|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.2165
71153015|NCT05407064|141798293|SUPERIORITY|||||||0.6868|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.6868
71153016|NCT05407064|141798293|SUPERIORITY|||||||0.135|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.1350
71153017|NCT05407064|141798293|SUPERIORITY|||||||0.0273|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0273
71153018|NCT05407064|141798294|SUPERIORITY|||||||0.245|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.2450
71153019|NCT05407064|141798294|SUPERIORITY|||||||0.3461|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.3461
71153020|NCT05407064|141798294|SUPERIORITY|||||||0.111|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.1110
71153021|NCT05407064|141798294|SUPERIORITY|||||||0.2386|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.2386
71153022|NCT05407064|141798295|SUPERIORITY|||||||0.1475|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1475
71153023|NCT05407064|141798295|SUPERIORITY|||||||0.0308|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0308
71153024|NCT05407064|141798295|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0000
71153025|NCT05407064|141798295|SUPERIORITY|||||||0.0004|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0004
71153026|NCT05407064|141798296|SUPERIORITY|||||||0.0873|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0873
71153027|NCT05407064|141798296|SUPERIORITY|||||||0.1702|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1702
71153028|NCT05407064|141798296|SUPERIORITY|||||||0.0007|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0007
71153029|NCT05407064|141798296|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0001
71153030|NCT05407064|141798297|SUPERIORITY|||||||0.4193|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.4193
71153031|NCT05407064|141798297|SUPERIORITY|||||||0.1663|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1663
71153032|NCT05407064|141798297|SUPERIORITY|||||||0.0002|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0002
71153033|NCT05407064|141798297|SUPERIORITY|||||||0.0306|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0306
71153034|NCT05407064|141798298|SUPERIORITY|||||||0.0534|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test||||0.0534
71153035|NCT05407064|141798298|SUPERIORITY|||||||0.6551|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test||||0.6551
71153036|NCT05407064|141798298|SUPERIORITY|||||||0.0079|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test||||0.0079
71153037|NCT05407064|141798298|SUPERIORITY|||||||0.1133|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test||||0.1133
71153038|NCT05407064|141798299|SUPERIORITY|||||||0.1248|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1248
71153039|NCT05407064|141798299|SUPERIORITY|||||||0.1788|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1788
71153040|NCT05407064|141798299|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0030
71153041|NCT05407064|141798299|SUPERIORITY|||||||0.0534|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0534
71153042|NCT02003924|141798348|SUPERIORITY||Hazard Ratio (HR)|0.292|||<|0.0001|TWO_SIDED|95.0|0.241|0.352||P-value was based on stratified log-rank test by prostate-specific antigen (PSA) doubling time (\< 6 months, \>= 6 months) and prior or concurrent use of a bone targeting agent (yes, no). Threshold for significance at 0.05 level.|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with \< 1 favoring Enzalutamide.|||0.352|0.241|<0.0001
71153043|NCT02003924|141798349|SUPERIORITY||Hazard Ratio (HR)|0.066|||<|0.0001|TWO_SIDED|95.0|0.054|0.081||P-value was based on a stratified log-rank test by PSA doubling time (\< 6 months, \>= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per IXRS. Threshold for significance at 0.02 level.|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with \< 1 favoring Enzalutamide.|To maintain the family-wise 2-sided type I error rate at 0.05, a parallel testing strategy between OS (with allocated type I error rate 0.03) and remaining key secondary endpoints (time to PSA progression and time to first use of new antineoplastic therapy with allocated type I error rate 0.02) was performed. Testing was performed only if the primary endpoint was statistically significant.||0.081|0.054|<0.0001
71153044|NCT02003924|141798350|SUPERIORITY||Hazard Ratio (HR)|0.208|||<|0.0001|TWO_SIDED|95.0|0.168|0.258||P-value was based on a stratified log-rank test by PSA doubling time (\< 6 months, \>= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per IXRS. Threshold for significance at 0.02 level.|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with \< 1 favoring Enzalutamide.|To maintain the family-wise 2-sided type I error rate at 0.05, a parallel testing strategy between OS (with allocated type I error rate 0.03) and remaining key secondary endpoints (time to PSA progression and time to first use of new antineoplastic therapy with allocated type I error rate 0.02) was performed. Testing was performed only if the previous endpoint was statistically significant.||0.258|0.168|<0.0001
71153045|NCT02003924|141798351|SUPERIORITY||Hazard Ratio (HR)|0.734||||0.0011|TWO_SIDED|95.0|0.608|0.885||P-value was based on a stratified log-rank test by PSA doubling time (\< 6 months, \>= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per interactive voice/web recognition system (IXRS).|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with \< 1 favoring Enzalutamide.|To maintain family-wise 2-sided type I error rate at 0.05,parallel testing strategy between OS(with allocated type I error rate 0.03)and remaining key secondary endpoints(time to PSA progression and time to first use of new antineoplastic therapy with allocated type I error rate 0.02)was performed.OS tested at error rate 0.05 when both time to PSA progression and time to first use of new antineoplastic therapy were significant. When either failed to show significance.OS was tested at error 0.03.||0.885|0.608|0.0011
71153046|NCT02003924|141798352|SUPERIORITY||Hazard Ratio (HR)|0.959||||0.6534|TWO_SIDED|95.0|0.801|1.149||P-value was based on a stratified log-rank test by PSA doubling time (\< 6 months, \>= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per IXRS.|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with \< 1 favoring Enzalutamide.|||1.149|0.801|0.6534
71153047|NCT02003924|141798353|SUPERIORITY||Hazard Ratio (HR)|0.378|||<|0.0001|TWO_SIDED|95.0|0.282|0.507||P-value was based on a stratified log-rank test by PSA doubling time (\< 6 months, \>= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per IXRS.|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with \< 1 favoring Enzalutamide.|||0.507|0.282|<0.0001
71153048|NCT02003924|141798356|SUPERIORITY||Difference in Response Rate|73.96|||<|0.0001|TWO_SIDED|95.0|70.91|77.02||P-value was based on a Cochran-Mantel-Haenszel mean score test stratified by PSA doubling time (\<6 months, \>= 6 months) and prior concurrent use of a bone targeting agent (yes, no) as per IXRS.|Cochran-Mantel-Haenszel|||Decrease from Baseline \>= 50%||77.02|70.91|<0.0001
71153049|NCT02003924|141798356|SUPERIORITY||Difference in Response Rate|55.52|||<|0.0001|TWO_SIDED|95.0|52.28|58.76||P-value was based on a Cochran-Mantel-Haenszel mean score test stratified by PSA doubling time (\<6 months, \>= 6 months) and prior concurrent use of a bone targeting agent (yes, no) as per IXRS|Cochran-Mantel-Haenszel|||Decrease from Baseline \>= 90%||58.76|52.28|<0.0001
71153050|NCT02003924|141798356|SUPERIORITY||Difference in Response Rate|9.65|||<|0.0001|TWO_SIDED|95.0|7.75|11.54||P-value was based on a Cochran-Mantel-Haenszel mean score test stratified by PSA doubling time (\<6 months, \>= 6 months) and prior concurrent use of a bone targeting agent (yes, no) as per IXRS.|Cochran-Mantel-Haenszel|||Decrease to Undetectable Level||11.54|7.75|<0.0001
71153051|NCT02641561|141798461|SUPERIORITY|||||||0.04|||||||Fisher Exact|||||||0.04
71153052|NCT00702715|141798462|NON_INFERIORITY_OR_EQUIVALENCE|The 95% confidence interval for the estimated median treatment difference in recovery time must have fallen entirely within the pre-specified interval between -60 sec to +60 sec in order to claim equivalence|Median Difference (Final Values)|78.0|||||TWO_SIDED|95.0|36.0|143.0|||Hodges-Lehmann and Moses||Estimated median treatment difference (severe renal impairment minus normal renal function) in recovery time (seconds)|||143.0|36.0|
71153053|NCT00702715|141798463|NON_INFERIORITY_OR_EQUIVALENCE|For the secondary endpoint no equivalence margin was specified (i.e., no formal null-hypothesis was specified); the median difference and associated 95% CI were to further characterize the efficacy of severe renal impaired subjects and controls.|Median Difference (Final Values)|68.0|||||TWO_SIDED|95.0|36.0|120.0|||Hodges-Lehmann and Moses||Estimated median treatment difference (severe renal impairment minus normal renal function) in recovery time (seconds)|||120.0|36.0|
71153054|NCT00702715|141798464|NON_INFERIORITY_OR_EQUIVALENCE|For the secondary endpoint no equivalence margin was specified (i.e., no formal null-hypothesis was specified); the median difference and associated 95% CI were to further characterize the efficacy of severe renal impaired subjects and controls.|Median Difference (Final Values)|60.0|||||TWO_SIDED|95.0|31.0|103.0|||Hodges-Lehmann and Moses||Estimated median treatment difference (severe renal impairment minus normal renal function) in recovery time (seconds)|||103.0|31.0|
71153055|NCT02082119|141798465|OTHER||||||<|0.05|||||||t-test, 1 sided|||||||<0.05
71153056|NCT02840799|141798471|SUPERIORITY||Mean Difference (Final Values)|-0.1309108|STANDARD_ERROR_OF_MEAN|0.2619326||0.6191|TWO_SIDED|95.0|-0.6552259|0.3934043||A two-sided α=0.05 was determined by the power calculation.|t-test, 2 sided|t = -0.49979, df = 58. N=59 due to analyzing participants with complete data for Phase 1 and Phase 2 that crossovered.|Only participants that successfully crossed over were included in the t-test (N=59).|We considered an increase in peak VO2 of \~0.6 ml/kg/min to be the minimum clinically significant change. Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints with a two-sided α=0.05. PASS11157 was used to perform power calculations.||0.3934043|-0.6552259|0.6191
71153057|NCT02840799|141798471|SUPERIORITY||Slope|0.1||||0.711|TWO_SIDED|95.0|-0.043|0.62||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||The mixed model analysis provided an assessment of the treatment effect on each continuous outcome of interest while controlling for effects of other covariates such as period, sequence, and a random subject effect.||0.62|-.043|0.711
71153058|NCT02840799|141798472|SUPERIORITY||Mean Difference (Final Values)|2.217657|STANDARD_ERROR_OF_MEAN|2.065196||0.2871|TWO_SIDED|95.0|-1.910612|6.3459261|||t-test, 2 sided|t = 1.0738, df = 62, p-value = 0.2871, N=63 due to analyzing participants with complete data for Phase 1 and Phase 2 that crossovered.||A two-sided α=0.05 was determined by the power calculation.||6.3459261|-1.910612|0.2871
71153059|NCT02840799|141798472|SUPERIORITY||Slope|-2.12||||0.2935|TWO_SIDED|95.0|-6.12|1.88||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||The mixed model analysis provided an assessment of the treatment effect on each continuous outcome of interest while controlling for effects of other covariates such as period, sequence, and a random subject effect. Randomization sequence was not included in the final model due to lack of evidence for a carry over effect. Phase 1 data for participants that did not crossover due to IDS were considered for the model (N=74).||1.88|-6.12|0.2935
71153060|NCT02840799|141798473|SUPERIORITY||Mean Difference (Final Values)|2.1859922|STANDARD_ERROR_OF_MEAN|1.578944||0.171|TWO_SIDED|95.0|-0.9674467|5.3392901||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|t=1.3844, df=65, p=0.171. N=66 due to analyzing participants with complete data for Phase 1 and Phase 2 that crossover correctly.||||5.3392901|-0.9674467|0.171
71153061|NCT02840799|141798473|SUPERIORITY||Slope|-2.51||||0.113|TWO_SIDED|95.0|-5.62|0.61||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||The mixed model analysis provided an assessment of the treatment effect on each continuous outcome of interest while controlling for effects of other covariates such as period, sequence, and a random subject effect.||0.61|-5.62|0.113
71153062|NCT02840799|141798474|SUPERIORITY||Mean Difference (Final Values)|2.776572|STANDARD_ERROR_OF_MEAN|3.99464||0.4905|TWO_SIDED|95.0|-5.264221|10.817366||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|t = 0.69507, df=46, p=.4905. N=47 due to only analyzed participants that correctly crossovered.||||10.817366|-5.264221|0.4905
71153063|NCT02840799|141798474|SUPERIORITY||Slope|1.088||||0.796|TWO_SIDED|95.0|-7.3|9.48||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||The mixed model analysis provided an assessment of the treatment effect on each continuous outcome of interest while controlling for effects of other covariates such as period, sequence, and a random subject effect.||9.48|-7.30|0.796
71153064|NCT02840799|141798475|SUPERIORITY||Mean Difference (Final Values)|-38.11189|STANDARD_ERROR_OF_MEAN|43.84245||0.4017|TWO_SIDED|95.0|-133.63637|57.41259|||t-test, 2 sided|t=-0.86929,, df=12, p=0.4017||||57.41259|-133.63637|0.4017
71153065|NCT02840799|141798475|SUPERIORITY||Slope|61.77||||0.183|TWO_SIDED|95.0|-34.15|157.69||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||||157.69|-34.15|0.183
71153066|NCT02840799|141798476|SUPERIORITY||Mean Difference (Final Values)|0.202782|STANDARD_ERROR_OF_MEAN|0.202782||0.5636|TWO_SIDED|95.0|-0.4959279|0.9014918||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|t=0.58074, df=59, p=0.5636||||0.9014918|-0.4959279|0.5636
71153067|NCT02840799|141798476|SUPERIORITY||Slope|-0.3118||||0.361|TWO_SIDED|95.0|-0.99|0.37||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||The mixed model analysis provided an assessment of the treatment effect on each continuous outcome of interest while controlling for effects of other covariates such as period, sequence, and a random subject effect.||0.37|-0.99|0.361
71153068|NCT02840799|141798477|SUPERIORITY||Mean Difference (Final Values)|-0.1532142|STANDARD_ERROR_OF_MEAN|-0.1532142||0.7707|TWO_SIDED|95.0|-1.1998786|0.8934502||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|t= -0.29271, df=61, p=0.7707||||0.8934502|-1.1998786|0.7707
71153069|NCT02840799|141798477|SUPERIORITY||Slope|0.18872||||0.724|TWO_SIDED|95.0|-0.88|1.25||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||The mixed model analysis provided an assessment of the treatment effect on each continuous outcome of interest while controlling for effects of other covariates such as period, sequence, and a random subject effect.||1.25|-0.88|0.724
71153070|NCT02840799|141798478|SUPERIORITY||Mean Difference (Final Values)|0.3262821|STANDARD_ERROR_OF_MEAN|0.2333465||0.1680825|TWO_SIDED|95.0|-0.1421806|0.7947447||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|t=1.3983, df=51, p=0.1681||||0.7947447|-0.1421806|0.1680825
71153071|NCT02840799|141798478|SUPERIORITY||Slope|-0.4082||||0.093|TWO_SIDED|95.0|-0.88|0.07||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||||0.07|-0.88|0.0930
71153072|NCT02840799|141798479|SUPERIORITY||Mean Difference (Final Values)|-2.116437|STANDARD_ERROR_OF_MEAN|1.176768||0.07984|TWO_SIDED|95.0|-4.4966754|0.2638017||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided||t = -1.7985, df=39, p=0.07984|||0.2638017|-4.4966754|0.07984
71153073|NCT02840799|141798479|SUPERIORITY||Slope|1.68||||0.135|TWO_SIDED|95.0|-0.54|3.9||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||||3.90|-0.54|0.135
71153074|NCT02840799|141798480|SUPERIORITY||Mean Difference (Final Values)|-0.0192733|STANDARD_ERROR_OF_MEAN|0.01295984||0.145|TWO_SIDED|95.0|-0.0454871|0.0069404||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|||||0.00694040|-0.0454871|0.1450
71153075|NCT02840799|141798480|SUPERIORITY||Slope|0.01324||||0.3047|TWO_SIDED|95.0|-0.01|0.04||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||||0.04|-0.01|0.3047
71153076|NCT02840799|141798481|SUPERIORITY||Mean Difference (Final Values)|-3.506681|STANDARD_ERROR_OF_MEAN|4.494971||0.44|TWO_SIDED|95.0|-12.598617|5.585256||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|||||5.585256|-12.598617|0.44
71153077|NCT02840799|141798481|SUPERIORITY||Slope|3.39106||||0.39911|TWO_SIDED|95.0|-4.66|11.44||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||||11.44|-4.66|0.39911
71153078|NCT01193257|141798496|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.875||||0.12085|TWO_SIDED|95.0|0.739|1.036|||Log Rank|||Hazard ratio is based on a stratified Cox's proportional hazard regression model with stratification factors region (North America, Europe and Rest of World) and brief pain inventory-short form (BPI-SF) worst pain score at screening (\[less than or equal to\] \<=4, greater than \[\>\] 4) with treatment as a factor in the model. A hazard ratio less than 1 for the treatment indicates better prevention of the death in the Orteronel arm as compared to placebo arm.||1.036|0.739|0.12085
71153079|NCT01193257|141798497|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.00038|TWO_SIDED|95.0|0.653|0.885|||Log Rank|||Hazard ratio is based on a stratified Cox's proportional hazard regression model with stratification factors region (North America, Europe and Rest of World) and brief pain inventory-short form (BPI-SF) worst pain score at screening (\<=4, \>4) with treatment as a factor in the model. A hazard ratio less than 1 for the treatment indicates better prevention of the death in the Orteronel arm as compared to placebo arm.||0.885|0.653|0.00038
71153080|NCT01193257|141798498|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Regression, Logistic|||P-values test for odds ratio equal to 1.||||< 0.0001
71153081|NCT01193257|141798499|SUPERIORITY_OR_OTHER|||||||0.12778|||||||Regression, Logistic|||P-values test for odds ratio equal to 1.||||0.12778
71153082|NCT01621802|141798527|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 1: Lower limit (LL) of the 2-sided 97.5% confidence interval (CI) for group difference (Inv\_MMR\_CO Group minus pooled Com\_MMR\_CO Group) in seroresponse rates to measles, mumps and rubella viruses is ≥ -5%.|Difference in seroresponse rate (%)|0.0|||||TWO_SIDED|97.5|-0.72|1.98|||||Difference in percentage (Inv\_MMR\_CO Group minus Com\_MMR\_CO Group) in percentage of subjects with an anti-measles antibody concentration ≥ 200 mIU/mL.|"Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 1 should be at least 94.04% (=100%- the sum of type II errors associated to cohort 1."||1.98|-0.72|
71153083|NCT01621802|141798527|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for group difference (Inv\_MMR\_I group minus pooled Com\_MMR\_I group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.|Difference in Seroresponse rate (%)|0.71|||||TWO_SIDED|97.5|0.02|2.97|||||Difference in percentage (Inv\_MMR\_I Group minus Com\_MMR\_I Group) in percentage of subjects with an anti-Measles antibody concentration ≥ 200 mIU/mL.|"Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 2 should be at least 98.88% (=100%- the sum of type II error associated to cohort 2."||2.97|0.02|
71153084|NCT01621802|141798528|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for group difference (Inv\_MMR\_CO Group minus pooled Com\_MMR\_CO Group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.|Difference in seroresponse rate (%)|0.0|||||TWO_SIDED|97.5|-0.72|1.97|||||Difference in percentage (Inv\_MMR\_CO Group minus Com\_MMR\_CO Group) in percentage of subjects with an anti-mumps antibody concentration ≥ 10 EU/mL.|"Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 1 should be at least 94.04% (=100%- the sum of type II errors associated to cohort 1."||1.97|-0.72|
71153085|NCT01621802|141798528|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for group difference (Inv\_MMR\_I group minus pooled Com\_MMR\_I group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.|Difference in Seroresponse rate (%)|0.0|||||TWO_SIDED|97.5|-0.68|1.75|||||Difference in percentage (Inv\_MMR\_I Group minus Com\_MMR\_I Group) in percentage of subjects with an anti-mumps antibody concentration ≥ 10 EU/mL.|"Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 2 should be at least 98.88% (=100%- the sum of type II error associated to cohort 2."||1.75|-0.68|
71153086|NCT01621802|141798529|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for group difference (Inv\_MMR\_CO group minus pooled Com\_MMR\_CO group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.|Difference in seroresponse rate (%)|-0.14|||||TWO_SIDED|97.5|-0.98|1.84|||||Difference in percentage (Inv\_MMR\_CO Group minus Com\_MMR\_CO Group) in percentage of subjects with an anti-rubella antibody concentration ≥ 10 IU/mL.|"Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 1 should be at least 94.04% (=100%- the sum of type II errors associated to cohort 1."||1.84|-0.98|
71153087|NCT01621802|141798529|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for group difference (Inv\_MMR\_I group minus pooled Com\_MMR\_I group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.|Difference in seroresponse rate (%)|0.0|||||TWO_SIDED|97.5|-0.68|1.75|||||Difference in percentage (Inv\_MMR\_I Group minus Com\_MMR\_I Group) in percentage of subjects with an anti-rubella antibody concentration ≥ 10 IU/mL.|"Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 2 should be at least 98.88% (=100%- the sum of type II error associated to cohort 2."||1.75|-0.68|
71153088|NCT01621802|141798530|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\_MMR\_CO group divided by pooled Com\_MMR\_CO group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|0.99|||||TWO_SIDED|97.5|0.92|1.06|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance|The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.|||1.06|0.92|
71153089|NCT01621802|141798530|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\_MMR\_I group divided by pooled Com\_MMR\_I group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|1.03|||||TWO_SIDED|97.5|0.96|1.1|||ANCOVA|Ancova model: adjustment for baseline concentration country - pooled variance|The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.|||1.10|0.96|
71153090|NCT01621802|141798531|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\_MMR\_CO group divided by pooled Com\_MMR\_CO group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|0.91|||||TWO_SIDED|97.5|0.83|1.0|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance|The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.|||1.00|0.83|
71153091|NCT01621802|141798531|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\_MMR\_I group divided by pooled Com\_MMR\_I group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|0.96|||||TWO_SIDED|97.5|0.87|1.06|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance.|The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.|||1.06|0.87|
71153092|NCT01621802|141798532|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\_MMR\_CO group divided by pooled Com\_MMR\_CO group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|1.03|||||TWO_SIDED|97.5|0.97|1.09|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance.|The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.|Adjusted geometric mean concentration (GMC) ratio (Inv\_MMR\_CO group divided by Com\_MMR\_CO group) for antibodies to rubella virus.||1.09|0.97|
71153093|NCT01621802|141798532|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\_MMR\_I group divided by pooled Com\_MMR\_I group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|1.01|||||TWO_SIDED|97.5|0.95|1.07|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance.|The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.|||1.07|0.95|
71153094|NCT02948634|141798553|SUPERIORITY|||||||0.43|||||||ANOVA|||||||0.43
71153095|NCT02948634|141798554|SUPERIORITY|||||||0.32|||||||ANOVA|||||||0.32
71153096|NCT02948634|141798555|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71153097|NCT04881942|141798625|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|89.44||||0.0184|TWO_SIDED|95.0|15.77|163.11|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham)|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||163.11|15.77|0.0184
71153098|NCT04881942|141798625|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|195.7|||<|0.0001|TWO_SIDED|95.0|122.01|269.38|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||269.38|122.01|<.0001
71153099|NCT04881942|141798625|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|168.83|||<|0.0001|TWO_SIDED|95.0|95.17|242.5|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||242.50|95.17|<.0001
71153100|NCT04881942|141798625|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|182.65|||<|0.0001|TWO_SIDED|95.0|108.63|256.67|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||256.67|108.63|<.0001
71153101|NCT04881942|141798628|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|5972.3|||<|0.0001|TWO_SIDED|95.0|4191.1|7753.6|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||7753.6|4191.1|<.0001
70969779|NCT03259074|141445127|SUPERIORITY|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|LS mean difference|-0.16|||||TWO_SIDED|95.0|-0.639|0.315|||||ANCOVA model with treatment as a factor and baseline mSASSS score as a covariate.|||0.315|-0.639|
71153102|NCT04881942|141798628|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|6099.5|||<|0.0001|TWO_SIDED|95.0|4317.8|7881.2|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||7881.2|4317.8|<.0001
71153103|NCT04881942|141798628|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|6484.7|||<|0.0001|TWO_SIDED|95.0|4701.7|8267.6|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||8267.6|4701.7|<.0001
71153104|NCT04881942|141798628|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|5366.8|||<|0.0001|TWO_SIDED|95.0|3575.9|7157.7|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||7157.7|3575.9|<.0001
71153105|NCT04881942|141798631|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|0.17||||0.915|TWO_SIDED|95.0|-2.92|3.25|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0.|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||3.25|-2.92|0.9150
71153106|NCT04881942|141798631|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|0.35||||0.8217|TWO_SIDED|95.0|-2.7|3.4|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||3.40|-2.70|0.8217
71153107|NCT04881942|141798631|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|21.11|||<|0.0001|TWO_SIDED|95.0|18.06|24.16|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0.|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||24.16|18.06|<.0001
71153108|NCT04881942|141798631|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|31.01|||<|0.0001|TWO_SIDED|95.0|27.91|34.12|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||34.12|27.91|<.0001
71153109|NCT04881942|141798634|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|1678.4||||0.0031|TWO_SIDED|95.0|592.14|2764.6|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||2764.6|592.14|.0031
71153110|NCT04881942|141798634|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|1199.7||||0.031|TWO_SIDED|95.0|113.74|2285.7|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||2285.7|113.74|.0310
71153111|NCT04881942|141798634|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|3354.5|||<|0.0001|TWO_SIDED|95.0|2266.6|4442.3|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||4442.3|2266.6|<.0001
71153112|NCT04881942|141798634|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|2511.0|||<|0.0001|TWO_SIDED|95.0|1416.1|3605.9|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||3605.9|1416.1|<.0001
71153113|NCT04881942|141798637|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|0.25||||0.0002|TWO_SIDED|95.0|0.12|0.38|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0.|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||0.38|0.12|.0002
71153114|NCT04881942|141798637|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|0.25||||0.0003|TWO_SIDED|95.0|0.12|0.38|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||0.38|0.12|0.0003
71153115|NCT04881942|141798637|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|0.34|||<|0.0001|TWO_SIDED|95.0|0.21|0.47|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||0.47|0.21|<.0001
71153116|NCT04881942|141798637|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|0.3|||<|0.0001|TWO_SIDED|95.0|0.17|0.43|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||0.43|0.17|<.0001
71153117|NCT04881942|141798644|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Final Values)|0.035|||<|0.0001|TWO_SIDED|95.0|0.031|0.039|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.039|0.031|<.0001
71153118|NCT04881942|141798644|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.034|||<|0.0001|TWO_SIDED|95.0|0.03|0.038|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.038|0.030|<.0001
71153119|NCT04881942|141798644|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.04|||<|0.0001|TWO_SIDED|95.0|0.036|0.044|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.044|0.036|<.0001
71153120|NCT04881942|141798644|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.037|||<|0.0001|TWO_SIDED|95.0|0.033|0.041|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.041|0.033|<.0001
71153121|NCT04881942|141798645|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.036|||<|0.0001|TWO_SIDED|95.0|0.031|0.04|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.040|0.031|<.0001
71153122|NCT04881942|141798645|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.036|||<|0.0001|TWO_SIDED|95.0|0.032|0.041|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.041|0.032|<.0001
71153123|NCT04881942|141798645|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.041|||<|0.0001|TWO_SIDED|95.0|0.037|0.046|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.046|0.037|<.0001
71153124|NCT04881942|141798645|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.038|||<|0.0001|TWO_SIDED|95.0|0.033|0.042|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.042|0.033|<.0001
71153125|NCT04881942|141798646|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.536|||<|0.0001|TWO_SIDED|95.0|0.407|0.665|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.665|0.407|<.0001
71153126|NCT04881942|141798646|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.408|||<|0.0001|TWO_SIDED|95.0|0.28|0.537|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.537|0.280|<.0001
71153127|NCT04881942|141798646|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.468|||<|0.0001|TWO_SIDED|95.0|0.339|0.596|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.596|0.339|<.0001
71153128|NCT04881942|141798646|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.43|||<|0.0001|TWO_SIDED|95.0|0.301|0.559|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.559|0.301|<.0001
71153129|NCT04881942|141798648|EQUIVALENCE|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0|Mean Difference (Final Values)|277.79|||<|0.0001|TWO_SIDED|95.0|213.62|341.96|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0||341.96|213.62|<.0001
71153130|NCT04881942|141798648|EQUIVALENCE|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0|Mean Difference (Final Values)|241.32|||<|0.0001|TWO_SIDED|95.0|176.99|305.64|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0||305.64|176.99|<.0001
70969780|NCT03259074|141445128|SUPERIORITY|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|Marginal difference|4.32|||||TWO_SIDED|95.0|-5.62|14.27|||||Logistic regression model with treatment as a factor and baseline count of vertebral corners with syndesmophyte as a covariate using marginal standardization method.|||14.27|-5.62|
71153131|NCT04881942|141798648|EQUIVALENCE|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0|Mean Difference (Final Values)|248.22|||<|0.0001|TWO_SIDED|95.0|184.01|312.43|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0||312.43|184.01|<.0001
71153132|NCT04881942|141798648|EQUIVALENCE|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0|Mean Difference (Final Values)|257.92|||<|0.0001|TWO_SIDED|95.0|193.58|322.26|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0||322.26|193.58|<.0001
71153133|NCT04881942|141798649|EQUIVALENCE|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0|Mean Difference (Final Values)|2.223|||<|0.0001|TWO_SIDED|95.0|1.915|2.58|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0||2.580|1.915|<.0001
71153134|NCT04881942|141798649|EQUIVALENCE|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0|Mean Difference (Final Values)|2.203|||<|0.0001|TWO_SIDED|95.0|1.897|2.557|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0||2.557|1.897|<.0001
71153135|NCT04881942|141798649|EQUIVALENCE|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0|Mean Difference (Final Values)|2.101|||<|0.0001|TWO_SIDED|95.0|1.81|2.439|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0||2.439|1.810|<.0001
71153136|NCT04881942|141798649|EQUIVALENCE|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0|Mean Difference (Final Values)|2.052|||<|0.0001|TWO_SIDED|95.0|1.767|2.382|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0||2.382|1.767|<.0001
71153137|NCT04881942|141798650|EQUIVALENCE|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0|Mean Difference (Final Values)|709.86|||<|0.0001|TWO_SIDED|95.0|549.19|870.54|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0||870.54|549.19|<.0001
71153138|NCT04881942|141798650|EQUIVALENCE|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0|Mean Difference (Final Values)|568.35|||<|0.0001|TWO_SIDED|95.0|407.18|729.51|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0||729.51|407.18|<.0001
71153139|NCT04881942|141798650|EQUIVALENCE|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0|Mean Difference (Final Values)|562.0|||<|0.0001|TWO_SIDED|95.0|401.34|722.67|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0||722.67|401.34|<.0001
71153140|NCT04881942|141798650|EQUIVALENCE|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0|Mean Difference (Final Values)|517.23|||<|0.0001|TWO_SIDED|95.0|356.11|678.34|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0||678.34|356.11|<.0001
71153141|NCT03860259|141798682|SUPERIORITY|||||||0.1771||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||24 hrs||||0.1771
71153142|NCT03860259|141798682|SUPERIORITY|||||||0.2833||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||48 hrs||||0.2833
71153143|NCT03860259|141798682|SUPERIORITY|||||||0.0909||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||72 hrs||||0.0909
71153144|NCT03860259|141798682|SUPERIORITY|||||||0.231||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||96 hrs||||0.2310
71153145|NCT03860259|141798682|SUPERIORITY|||||||0.0801|||||||t-test, 1 sided|||120 hrs||||0.0801
71153146|NCT03860259|141798682|SUPERIORITY|||||||0.0307||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Total||||0.0307
70969781|NCT03259074|141445128|SUPERIORITY|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|Marginal difference|1.09|||||TWO_SIDED|95.0|-9.13|11.31|||||Logistic regression model with treatment as a factor and baseline count of vertebral corners with syndesmophyte as a covariate using marginal standardization method.|||11.31|-9.13|
71153147|NCT03860259|141798683|SUPERIORITY|||||||0.1956||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||24 hrs||||0.1956
71153148|NCT03860259|141798683|SUPERIORITY|||||||0.2274||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||48 hrs||||0.2274
71153149|NCT03860259|141798683|SUPERIORITY|||||||0.109||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||72 hrs||||0.1090
71153150|NCT03860259|141798683|SUPERIORITY|||||||0.1618||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||96 hrs||||0.1618
71153151|NCT03860259|141798683|SUPERIORITY|||||||0.1264||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||120 hrs||||0.1264
71153152|NCT03860259|141798683|SUPERIORITY|||||||0.0394||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 14||||0.0394
71153153|NCT03860259|141798683|SUPERIORITY|||||||0.3968||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 30||||0.3968
71153154|NCT03860259|141798683|SUPERIORITY|||||||0.3407||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 60||||0.3407
71153155|NCT03860259|141798683|SUPERIORITY|||||||0.4033||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 90||||0.4033
71153156|NCT03860259|141798684|SUPERIORITY|||||||0.1707||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Time of discharge||||0.1707
71153157|NCT03860259|141798684|SUPERIORITY|||||||0.3446||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||24 hrs||||0.3446
71153158|NCT03860259|141798684|SUPERIORITY|||||||0.431|||||||t-test, 1 sided|||48 hrs||||0.4310
71153159|NCT03860259|141798684|SUPERIORITY|||||||0.3143||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||72 hrs||||0.3143
71153160|NCT03860259|141798684|SUPERIORITY|||||||0.4749||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||96 hrs||||0.4749
71153161|NCT03860259|141798684|SUPERIORITY|||||||0.3728||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||120 hrs||||0.3728
71153162|NCT03860259|141798684|SUPERIORITY|||||||0.1628|||||||t-test, 1 sided|||Day 14||||0.1628
71153163|NCT03860259|141798684|SUPERIORITY|||||||0.0731||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 30||||0.0731
71153164|NCT03860259|141798684|SUPERIORITY|||||||0.4909||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 60||||0.4909
71153165|NCT03860259|141798684|SUPERIORITY|||||||0.4411||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 90||||0.4411
71153166|NCT03860259|141798685|SUPERIORITY|||||||0.1786||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Acetaminophen||||0.1786
71153167|NCT03860259|141798685|SUPERIORITY|||||||0.1876||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Ibuprofen||||0.1876
71153168|NCT03860259|141798686|SUPERIORITY|||||||0.3638||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Baseline PCS||||0.3638
71153169|NCT03860259|141798686|SUPERIORITY|||||||0.0856||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 14 PCS||||0.0856
71153170|NCT03860259|141798686|SUPERIORITY|||||||0.4428||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 30 PCS||||0.4428
71153171|NCT03860259|141798686|SUPERIORITY|||||||0.3378||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 60 PCS||||0.3378
71153172|NCT03860259|141798686|SUPERIORITY|||||||0.3942||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 90 PCS||||0.3942
71153173|NCT03860259|141798686|SUPERIORITY|||||||0.219||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Baseline MCS||||0.2190
71153174|NCT03860259|141798686|SUPERIORITY|||||||0.1112||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 14 MCS||||0.1112
71153175|NCT03860259|141798686|SUPERIORITY|||||||0.1737||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 30 MCS||||0.1737
71153176|NCT03860259|141798686|SUPERIORITY|||||||0.2408||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 60 MCS||||0.2408
71153177|NCT03860259|141798686|SUPERIORITY|||||||0.038||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 90 MCS||||0.0380
71153178|NCT03860259|141798687|SUPERIORITY|||||||0.222||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||||||0.2220
71153179|NCT03860259|141798688|SUPERIORITY|||||||0.2856||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||||||0.2856
70969782|NCT03259074|141445129|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|LS Means|0.183|STANDARD_ERROR_OF_MEAN|0.1517|||TWO_SIDED|95.0|-0.12|0.48|||||LS Means and 95% CI are from an ANCOVA model with treatment as a factor, baseline Berlin SI joint edema score as a covariate.|Week 104 - 150 mg||0.48|-0.12|
71153180|NCT03860259|141798691|SUPERIORITY|||||||0.2241|||||||t-test, 1 sided|||||||0.2241
71153181|NCT03860259|141798692|SUPERIORITY|||||||0.2714||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Time of discharge||||0.2714
71153182|NCT03860259|141798692|SUPERIORITY|||||||0.3749||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||24 hrs||||0.3749
71153183|NCT03860259|141798692|SUPERIORITY|||||||0.3862||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||48 hrs||||0.3862
71153184|NCT03860259|141798692|SUPERIORITY|||||||0.1735||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||72 hrs||||0.1735
71153185|NCT03860259|141798692|SUPERIORITY|||||||0.4304||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||96 hrs||||0.4304
71153186|NCT03860259|141798692|SUPERIORITY|||||||0.4902||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||120 hrs||||0.4902
71153187|NCT03860259|141798692|SUPERIORITY|||||||0.4371||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 14||||0.4371
71153188|NCT03860259|141798692|SUPERIORITY|||||||0.195||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 30||||0.1950
71153189|NCT03860259|141798692|SUPERIORITY|||||||0.4124|||||||t-test, 1 sided|||Day 60||||0.4124
71153190|NCT03860259|141798692|SUPERIORITY|||||||0.0268||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 90||||0.0268
71153191|NCT02280408|141798724|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
71153192|NCT02280408|141798724|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
71153193|NCT02280408|141798724|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
71153194|NCT02280408|141798724|OTHER|||||||0.01|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.010
71153195|NCT02280408|141798724|OTHER|||||||0.011|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.011
71153196|NCT02280408|141798724|OTHER|||||||0.969|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||0.969
71153197|NCT02280408|141798725|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||<0.001
71153198|NCT02280408|141798725|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||<0.001
71153199|NCT02280408|141798725|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||<0.001
71153200|NCT02280408|141798725|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||<0.001
71153201|NCT02280408|141798725|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||<0.001
71153202|NCT02280408|141798725|OTHER|||||||0.733|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||0.733
71153203|NCT02280408|141798726|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
71153204|NCT02280408|141798726|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
71153205|NCT02280408|141798726|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
71153206|NCT02280408|141798726|OTHER|||||||0.132|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.132
71153207|NCT02280408|141798726|OTHER|||||||0.07|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.070
71153208|NCT02280408|141798726|OTHER|||||||0.743|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.743
71153209|NCT02280408|141798727|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
71153210|NCT02280408|141798727|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
71153211|NCT02280408|141798727|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
71153212|NCT02280408|141798727|OTHER|||||||0.014|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.014
71153213|NCT02280408|141798727|OTHER|||||||0.011|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.011
71153214|NCT02280408|141798727|OTHER|||||||0.923|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.923
71153215|NCT05300763|141798738|SUPERIORITY|Superiority was declared if the lower bound of the 2-sided 95% confidence interval is above 1.|Odds Ratio (OR)|2.01|||||TWO_SIDED|95.0|1.25|3.22|||Linear Mixed Model||Odds Ratio was calculated as Test over Control.|||3.22|1.25|
71153216|NCT05300763|141798739|SUPERIORITY|Superiority was declared if the lower bound of the 2-sided adjusted (96.25%) confidence interval is above 1.|Odds Ratio (OR)|2.0|||||TWO_SIDED|96.25|1.18|3.41|||Linear Mixed Model||Odds Ratio was calculated as Test over Control.|||3.41|1.18|
71153217|NCT05300763|141798740|SUPERIORITY|Superiority was declared if the lower bound of the 2-sided adjusted (97.5 %) confidence interval is above 1.|Odds Ratio (OR)|2.17|||||TWO_SIDED|97.5|1.3|3.64|||Linear Mixed Model||Odds Ratio was calculated as Test over Control.|||3.64|1.30|
71153218|NCT05300763|141798741|SUPERIORITY|Superiority was declared if the lower bound of the 2-sided 95% confidence interval is above 1.|Odds Ratio (OR)|1.77|||||TWO_SIDED|95.0|1.04|3.02|||Linear Mixed Model||Odds Ratio was calculated as Test over Control.|||3.02|1.04|
71153219|NCT01594528|141798742|OTHER|||||||0.992||||||comparison between groups for body indicators|Wilcoxon (Mann-Whitney)|||||||0.992
71153220|NCT01594528|141798742|OTHER|||||||0.8||||||comparison between groups facial indicators|Wilcoxon (Mann-Whitney)|||||||0.8
71153221|NCT01594528|141798742|OTHER|||||||0.586||||||comparison between groups for vocal indicators|Wilcoxon (Mann-Whitney)|||||||0.586
71153222|NCT00670306|141798822|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.6|STANDARD_DEVIATION|7.1|<|0.001|||||||t-test, 2 sided|||||||<0.001
71153223|NCT01032889|141798826|SUPERIORITY_OR_OTHER||Difference from placebo|-0.3||||0.052|TWO_SIDED|95.0|-0.61|0.0|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.||0.00|-0.61|0.052
71153224|NCT01032889|141798826|SUPERIORITY_OR_OTHER||Difference from placebo|-0.5||||0.003|TWO_SIDED|95.0|-0.77|-0.16|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.||-0.16|-0.77|0.003
71153225|NCT01032889|141798827|SUPERIORITY_OR_OTHER||Difference from placebo|-0.2||||0.117|TWO_SIDED|95.0|-0.55|0.06|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.||0.06|-0.55|0.117
71153226|NCT01032889|141798827|SUPERIORITY_OR_OTHER||Difference from placebo|-0.6|||<|0.001|TWO_SIDED|95.0|-0.91|-0.3|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.||-0.30|-0.91|<0.001
70969783|NCT03259074|141445129|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented|LS Means|0.332|STANDARD_ERROR_OF_MEAN|0.1545|||TWO_SIDED|95.0|0.03|0.64|||||LS Means and 95% CI are from an ANCOVA model with treatment as a factor, baseline Berlin SI joint edema score as a covariate.|Week 104 - 300 mg||0.64|0.03|
71153227|NCT01032889|141798828|SUPERIORITY_OR_OTHER||Difference from placebo|-1.4||||0.005|TWO_SIDED|95.0|-2.44|-0.46|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.||-0.46|-2.44|0.005
71153228|NCT01032889|141798828|SUPERIORITY_OR_OTHER||Difference from placebo|-2.5|||<|0.001|TWO_SIDED|95.0|-3.48|-1.48|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.||-1.48|-3.48|<0.001
71153229|NCT01032889|141798829|SUPERIORITY_OR_OTHER||Difference from placebo|-606.0||||0.166|TWO_SIDED|95.0|-1482.0|269.3|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||||269.3|-1482|0.166
71153230|NCT01032889|141798829|SUPERIORITY_OR_OTHER||Difference from placebo|-110.0||||0.803|TWO_SIDED|95.0|-1013.0|792.6|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||||792.6|-1013|0.803
71153231|NCT01032889|141798830|SUPERIORITY_OR_OTHER||Difference from placebo|-1.5|||<|0.001|TWO_SIDED|95.0|-2.32|-0.69|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||||-0.69|-2.32|<0.001
71153232|NCT01032889|141798830|SUPERIORITY_OR_OTHER||Difference from placebo|-1.7|||<|0.001|TWO_SIDED|95.0|-2.46|-0.85|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||||-0.85|-2.46|<0.001
71153233|NCT00912197|141798849|SUPERIORITY|||||||0.135|||||||ANCOVA|||||||0.135
71153234|NCT00912197|141798850|SUPERIORITY|||||||0.688|||||||ANCOVA|||||||0.688
71153235|NCT00912197|141798851|SUPERIORITY|||||||0.715|||||||t-test, 2 sided|||after treatment, 56 days||||0.715
71153236|NCT00912197|141798852|SUPERIORITY|||||||0.578|||||||ANCOVA|||||||0.578
71153237|NCT00912197|141798852|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||baseline to after treatment, at 56 days||||0.007
71153238|NCT00912197|141798852|SUPERIORITY|||||||0.05||||||calculated|t-test, 2 sided|||baseline to after treatment, at 56 days||||0.05
71153239|NCT00912197|141798856|SUPERIORITY|||||||0.024|||||||ANCOVA|||Acetate||||0.024
71153240|NCT00756613|141798861|EQUIVALENCE|We considered a 20% reduction in primary events to be a reasonable goal of intensive glycemic control over the anticipated 15-year study time period. This effect size was chosen by taking into consideration both the probability of observing an effect of that size given the level of achieved A1c separation, and the perceived value to the patient of this level of benefit relative to the risk and burden of intensive glycemic control.|Cox Proportional Hazard|0.91||||0.24|TWO_SIDED|95.0|0.78|1.06|||Regression, Cox|||To determine the long term effects of intensive glycemic control in type 2 diabetes on major cardiovascular events.||1.06|0.78|0.24
71153241|NCT00756613|141798862|EQUIVALENCE|The equivalence margin is expected 20% reduction for the intensive treatment group compared to the standard treatment group.|Cox Proportional Hazard|1.02||||0.81|TWO_SIDED|95.0|0.88|1.18|||Regression, Cox|||||1.18|0.88|0.81
70969784|NCT03259074|141445130|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|LS Means|0.877|STANDARD_ERROR_OF_MEAN|0.3316|||TWO_SIDED|95.0|0.22|1.53|||||LS Means and 95% CI are from an ANCOVA model with treatment as a factor, baseline Berlin SI joint edema score as a covariate.|Week 104 - 150 mg||1.53|0.22|
71153242|NCT00756613|141798863|EQUIVALENCE|The equivalence margin is 20% reduction of intensive treatment group versus standard treatment group.|Cox Proportional Hazard|0.9||||0.48|TWO_SIDED|95.0|0.67|1.2|||Regression, Cox|||||1.20|0.67|0.48
71153243|NCT00756613|141798865|EQUIVALENCE|T-test comparing between the two groups of treatment using the average score of last two surveys.|Mean Difference (Final Values)|1.61||||0.172|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.172
71153244|NCT03801044|141798867|OTHER|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
71153245|NCT01326104|141798891|SUPERIORITY||comparing two curves|0.286||||0.927|TWO_SIDED|90.0|0.107|0.764||This is the p-value comparing Group A with historical control.|Log Rank|One sample log rank.||Based on published literature, PFS-12 for patients with recurrent disease after initiating treatment with HDC + PBSCT or standard salvage therapy was 33% (95% confidence interval of 10%, 59%). The study was designed to differentiate between a PFS-12 rate of 33% (null hypothesis) and 55% (alternative hypothesis). If 35 patients enrolled, this assessment has 90% power assuming a type I error rate of 0.10. We assume that PFS of historical controls follows exponential distribution.||0.764|0.107|0.927
71153246|NCT01326104|141798891|SUPERIORITY||compare two curves|0.0|||<|0.001|TWO_SIDED|||||This is the p-value comparing Group B with historical control.|Log Rank|||Based on published literature, PFS-12 for patients with recurrent disease after initiating treatment with HDC + PBSCT or standard salvage therapy was 33% (95% confidence interval of 10%, 59%). The study was designed to differentiate between a PFS-12 rate of 33% (null hypothesis) and 55% (alternative hypothesis). If 35 patients enrolled, this assessment has 90% power assuming a type I error rate of 0.10. We assume that PFS of historical controls follows exponential distribution.||||<0.001
71153247|NCT01326104|141798891|SUPERIORITY||Comparing two curves|0.091|||<|0.001|TWO_SIDED|90.0|0.03|0.276||This is the p-value comparing Groups A and B combined with historical control.|Log Rank|||||0.276|0.03|<0.001
71153248|NCT01287741|141798897|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.4753|TWO_SIDED|95.0|0.78|1.12|||Log Rank|Stratified by International Prognostic Index (IPI) score (low/low-intermediate (excluding participants having an IPI score 0 without bulky disease).||||1.12|0.78|0.4753
71153249|NCT01287741|141798898|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.2736|TWO_SIDED|95.0|0.72|1.1|||Log Rank|Stratified by International Prognostic Index (IPI) score (low/low-intermediate (excluding participants having an IPI score 0 without bulky disease).||||1.10|0.72|0.2736
71153250|NCT04421027|141798913|SUPERIORITY||Odds Ratio (OR)|0.85||||0.18|TWO_SIDED|95.0|0.67|1.08|||Regression, Logistic|||||1.08|0.67|0.1800
71153251|NCT04421027|141798914|SUPERIORITY||Odds Ratio (OR)|1.12||||0.728|TWO_SIDED|95.0|0.58|2.16|||Regression, Logistic|||||2.16|0.58|0.7280
70969785|NCT03259074|141445130|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented|LS Means|0.419|STANDARD_ERROR_OF_MEAN|0.3357|||TWO_SIDED|95.0|-0.24|1.08|||||LS Means and 95% CI are from an ANCOVA model with treatment as a factor, baseline Berlin SI joint edema score as a covariate.|Week 104 - 300 mg||1.08|-0.24|
71153252|NCT04421027|141798915|SUPERIORITY||Odds Ratio (OR)|1.07||||0.5444|TWO_SIDED|95.0|0.86|1.34|||Regression, Logistic|||||1.34|0.86|0.5444
71153253|NCT04421027|141798916|SUPERIORITY||LS Mean difference (net)|0.75|STANDARD_ERROR_OF_MEAN|0.399||0.0586|TWO_SIDED|95.0|0.0|1.5|||ANOVA|||||1.5|-0.0|0.0586
71153254|NCT04421027|141798917|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.1453|TWO_SIDED|95.0|0.99|1.24|||Log Rank|||||1.24|0.99|0.1453
71153255|NCT04421027|141798918|SUPERIORITY||Odds Ratio (OR)|1.21||||0.0464|TWO_SIDED|95.0|1.0|1.47|||Proportional Odds Model|||Day 4||1.47|1.00|0.0464
71091967|NCT01126424|141690518|SUPERIORITY_OR_OTHER||Least Square Mean Difference|17.508||||0.4487|TWO_SIDED|95.0|-28.854|63.87|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||63.870|-28.854|0.4487
71153256|NCT04421027|141798919|SUPERIORITY||Odds Ratio (OR)|1.25||||0.0172|TWO_SIDED|95.0|1.04|1.49|||Proportional Odds Model|||||1.49|1.04|0.0172
71153257|NCT04421027|141798920|SUPERIORITY||Odds Ratio (OR)|1.17||||0.0921|TWO_SIDED|95.0|0.97|1.41|||Proportional Odds Model|||||1.41|0.97|0.0921
71153258|NCT04421027|141798921|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0168|TWO_SIDED|95.0|1.05|1.56|||Proportional Odds Model|||||1.56|1.05|0.0168
71153259|NCT04421027|141798922|SUPERIORITY||LS Mean Difference (Net)|-0.76|STANDARD_ERROR_OF_MEAN|0.408||0.0626|TWO_SIDED|95.0|-1.6|0.0|||ANOVA|||||0.0|-1.6|0.0626
71153260|NCT04421027|141798923|SUPERIORITY||Odds Ratio (OR)|1.15||||0.429|TWO_SIDED|95.0|0.81|1.63|||Regression, Logistic|||||1.63|0.81|0.4290
71153261|NCT04421027|141798924|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.0018|TWO_SIDED|95.0|0.41|0.78|||Log Rank|||||0.78|0.41|0.0018
71153262|NCT04421027|141798925|SUPERIORITY||LS Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.323||0.9526|TWO_SIDED|95.0|-0.62|0.65|||ANOVA|||||0.65|-0.62|0.9526
71153263|NCT04421027|141798926|SUPERIORITY||Hazard Ratio (HR)|0.887||||0.1831|TWO_SIDED|95.0|0.741|1.061|||Log Rank|||||1.061|0.741|0.1831
71153264|NCT04421027|141798927|SUPERIORITY||Hazard Ratio (HR)|1.202||||0.0243|TWO_SIDED|95.0|1.017|1.421|||Log Rank|||||1.421|1.017|0.0243
71153265|NCT04421027|141798928|SUPERIORITY||LS Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.128||0.191|TWO_SIDED|95.0|-0.42|0.08|||Mixed Models Analysis|||Day 4||0.08|-0.42|0.191
71153266|NCT04421027|141798928|SUPERIORITY||LS Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.161||0.278|TWO_SIDED|95.0|-0.49|0.14|||Mixed Models Analysis|||Day 7||0.14|-0.49|0.278
71153267|NCT04421027|141798928|SUPERIORITY||LS Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.187||0.496|TWO_SIDED|95.0|-0.49|0.24|||Mixed Models Analysis|||Day 10||0.24|-0.49|0.496
71153268|NCT04421027|141798928|SUPERIORITY||LS Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.226||0.263|TWO_SIDED|95.0|-0.7|0.19|||Mixed Models Analysis|||Day 14||0.19|-0.70|0.263
71153269|NCT04421027|141798930|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.6436|TWO_SIDED||||||Log Rank|||||||0.6436
71153270|NCT04421027|141798931|SUPERIORITY||Hazard Ratio (HR)|1.124||||0.127|TWO_SIDED||||||Log Rank|||||||0.1270
71153271|NCT04421027|141798932|SUPERIORITY||LS Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.228||0.3058|TWO_SIDED|95.0|-0.68|0.21|||ANOVA|||||0.21|-0.68|0.3058
71153272|NCT04421027|141798933|SUPERIORITY||LS Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.306||0.7073|TWO_SIDED|95.0|-0.49|0.72|||ANOVA|||||0.72|-0.49|0.7073
71153273|NCT02930018|141798966|SUPERIORITY|It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS (Acute Ischemic Stroke) patients with prior administration of alteplase as part of standard-of-care.|Odds Ratio (OR)|1.146||||0.335|TWO_SIDED|95.0|0.869|1.511||2 sided 0.05 significance level.|Regression, Logistic|||The primary hypothesis was that administration of nerinetide (NA-1) would result in an increase in the proportion of responders. The primary analysis was a Wald test for treatment group difference in the primary outcome from a logistic regression adjusted for the 2 stratification variables (alteplase use, first declared thrombectomy device), and the 6 covariates used in the minimization. The trial was designed to have 80% power to detect an 8.7% absolute difference between groups.||1.511|0.869|0.335
71153274|NCT02930018|141798967|SUPERIORITY|It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.|Odds Ratio (OR)|1.024||||0.866|TWO_SIDED|95.0|0.781|1.342||2 sided 0.05 significance level.|Regression, Logistic|||||1.342|0.781|0.866
71153275|NCT02930018|141798968|SUPERIORITY|It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.|Odds Ratio (OR)|0.776||||0.199|TWO_SIDED|95.0|0.527|1.143||2 sided 0.05 significance level.|Regression, Logistic|||||1.143|0.527|0.199
71153276|NCT02930018|141798969|SUPERIORITY||Odds Ratio (OR)|1.657||||0.028|TWO_SIDED|95.0|1.055|2.603|||Regression, Logistic|||||2.603|1.055|0.028
71153277|NCT02930018|141798969|SUPERIORITY||Absolute Risk Difference (%)|9.6|||||TWO_SIDED||||||||The unadjusted absolute risk difference in % between nerinetide and placebo in the no-alteplase subgroup.|||||
71153278|NCT02930018|141798969|SUPERIORITY||Relative Risk Difference (%)|19.3|||||TWO_SIDED||||||||The unadjusted relative risk difference in % between nerinetide and placebo in the no-alteplase subgroup.|||||
71153279|NCT02930018|141798970|SUPERIORITY||Odds Ratio (OR)|1.482||||0.088|TWO_SIDED|95.0|0.943|2.329|||Regression, Logistic|||||2.329|0.943|0.088
71153280|NCT02930018|141798970|SUPERIORITY||Absolute Risk Difference (%)|9.1|||||TWO_SIDED||||||||The unadjusted absolute risk difference in % between nerinetide and placebo in the no-alteplase subgroup.|||||
71153281|NCT02930018|141798970|SUPERIORITY||Relative Risk Difference (%)|18.3|||||TWO_SIDED||||||||The unadjusted relative risk difference in % between nerinetide and placebo in the no-alteplase subgroup.|||||
71153282|NCT02930018|141798971|SUPERIORITY||Odds Ratio (OR)|0.572||||0.055|TWO_SIDED|95.0|0.323|1.013|||Regression, Logistic|||||1.013|0.323|0.055
71153283|NCT02930018|141798971|SUPERIORITY||Absolute Risk Difference (%)|7.5|||||TWO_SIDED||||||||The unadjusted absolute risk difference in % between nerinetide and placebo in the no-alteplase subgroup.|||||
71153284|NCT02930018|141798971|SUPERIORITY||Relative Risk Difference (%)|39.7|||||TWO_SIDED||||||||The unadjusted relative risk difference in % between nerinetide and placebo in the no-alteplase subgroup.|||||
71153285|NCT02930018|141798972|SUPERIORITY|It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.|Odds Ratio (OR)|0.887||||0.529|TWO_SIDED|95.0|0.612|1.286|||Regression, Logistic|||||1.286|0.612|0.529
71153286|NCT02930018|141798973|SUPERIORITY|It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.|Odds Ratio (OR)|0.782||||0.181|TWO_SIDED|95.0|0.545|1.121|||Regression, Logistic|||||1.121|0.545|0.181
71153287|NCT02930018|141798974|SUPERIORITY|It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.|Odds Ratio (OR)|1.05||||0.869|TWO_SIDED|95.0|0.588|1.874|||Regression, Logistic|||||1.874|0.588|0.869
71153288|NCT04193189|141798976|NON_INFERIORITY|Pre-specified non-inferiority margin (2-CpG minus 3-alum): -10%.|Common proportion difference|12.5|||||TWO_SIDED|97.5|4.1|20.9|||||Common SPR proportion (expressed as percentage of participants) difference (2-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Primary objective of Group A||20.9|4.1|
71153289|NCT04193189|141798976|SUPERIORITY||Common proportion difference|18.4|||||TWO_SIDED|97.5|10.4|26.2|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 3-alum) with two-sided 97.5% Newcombe repeated confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Primary objective of Group A||26.2|10.4|
71153290|NCT04193189|141798976|SUPERIORITY||Common proportion difference|6.0|||||TWO_SIDED|97.5|-0.2|11.8|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 2-CpG) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Secondary objective of Group A||11.8|-0.2|
71153291|NCT04193189|141798978|SUPERIORITY||Common proportion difference|9.0|||||TWO_SIDED|97.5|0.1|18.1|||||Common SPR proportion (expressed as percentage of participants) difference (2-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 2-CpG and 3-alum at 4 weeks post last scheduled vaccination (Week 8 in 2-CpG, Week 28 in 3-alum)||18.1|0.1|
71153292|NCT04193189|141798978|SUPERIORITY||Common proportion difference|19.0|||||TWO_SIDED|97.5|10.0|27.9|||||Common SPR proportion (expressed as percentage of participants) difference (2-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 2-CpG and 3-alum at 8 weeks post last scheduled vaccination (Week 12 in 2-CpG, Week 32 in 3-alum)||27.9|10.0|
71153293|NCT04193189|141798978|SUPERIORITY||Common proportion difference|27.8|||||TWO_SIDED|97.5|17.7|37.2|||||Common SP proportion (expressed as percentage of participants) difference (2-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 2-CpG and 3-alum at 24 weeks post last scheduled vaccination (Week 28 in 2-CpG, Week 48 in 3-alum)||37.2|17.7|
71153294|NCT04193189|141798978|SUPERIORITY||Common proportion difference|32.3|||||TWO_SIDED|97.5|21.3|42.3|||||Common SPR proportion (expressed as percentage of participants) difference (2-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 2-CpG and 3-alum at 48 weeks post last scheduled vaccination (Week 52 in 2-CpG, Week 72 in 3-alum)||42.3|21.3|
71153295|NCT04193189|141798978|SUPERIORITY||Common proportion difference|23.8|||||TWO_SIDED|97.5|15.5|32.3|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 3-alum at 8 weeks post last scheduled vaccination (Week 32)||32.3|15.5|
71153296|NCT04193189|141798978|SUPERIORITY||Common proportion difference|32.3|||||TWO_SIDED|97.5|23.2|41.2|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 3-alum at 24 weeks post last scheduled vaccination (Week 48)||41.2|23.2|
71153297|NCT04193189|141798978|SUPERIORITY||Common proportion difference|38.8|||||TWO_SIDED|97.5|28.9|48.1|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 3-alum at 48 weeks post last scheduled vaccination (Week 72)||48.1|28.9|
71153298|NCT04193189|141798978|SUPERIORITY||Common proportion difference|10.0|||||TWO_SIDED|97.5|3.1|16.4|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 2-CpG) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 2-CpG at 4 weeks post last scheduled vaccination (Week 28 in 3-CpG, Week 8 in 2-CpG)||16.4|3.1|
71153299|NCT04193189|141798978|SUPERIORITY||Common proportion difference|4.8|||||TWO_SIDED|97.5|-0.8|10.5|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 2-CpG) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 2-CpG at 8 weeks post last scheduled vaccination (Week 32 in 3-CpG, Week 12 in 2-CpG)||10.5|-0.8|
71153300|NCT04193189|141798978|SUPERIORITY||Common proportion difference|4.9|||||TWO_SIDED|97.5|-0.8|11.2|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 2-CpG) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 2-CpG at 24 weeks post last scheduled vaccination (Week 48 in 3-CpG, Week 28 in 2-CpG)||11.2|-0.8|
71153301|NCT04193189|141798978|SUPERIORITY||Common proportion difference|7.2|||||TWO_SIDED|97.5|0.7|14.2|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 2-CpG) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 2-CpG at 48 weeks post last scheduled vaccination (Week 72 in 3-CpG, Week 52 in 2-CpG)||14.2|0.7|
71153302|NCT02685267|141798983|OTHER|The study was terminated after only 9 patients enrolled, 5 to the standard of care docetaxel/prednisone arm and 4 to experimental docetaxel/prednisone/enzalutamide arm.|log-rank test|0.6761||||0.6761|TWO_SIDED|95.0|||||Chi-squared|||The study was terminated after only 9 patients enrolled, 5 to the standard of care docetaxel/prednisone arm and 4 to experimental docetaxel/prednisone/enzalutamide arm.||||0.6761
71153303|NCT01027806|141798991|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71153304|NCT00943072|141799016|SUPERIORITY_OR_OTHER||Risk Difference (RD)|44.8|||<|0.0001|TWO_SIDED|95.0|33.0|56.6||P-value for the primary endpoint was calculated using 2-sided Cochran-Mantel-Haenszel test adjusted by regions (North America vs. Rest of World) and baseline BCVA (BCVA \> 20/200 and BCVA ≤ 20/200)|Cochran-Mantel-Haenszel|CMH adjusted difference|The Risk Difference (RD) indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group.|||56.6|33.0|< 0.0001
71153305|NCT00943072|141799017|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.7|||<|0.0001|TWO_SIDED|95.0|17.36|26.04|||ANCOVA||RD is the IAI group minus sham group. 95% confidence interval is for the RD.|||26.04|17.36|< 0.0001
71153306|NCT00943072|141799017|SUPERIORITY_OR_OTHER||Least Square Mean|16.36|||||||||||ANCOVA||LS Mean indicates is the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group.|||||
71153307|NCT00943072|141799018|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-311.9|||<|0.0001|TWO_SIDED|95.0|-389.4|-234.4|||ANCOVA||The Risk Difference (RD) indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group. 95% confidence interval is for the RD.|||-234.4|-389.4|< 0.0001
71153308|NCT00943072|141799018|SUPERIORITY_OR_OTHER||Least Square Mean|-487.1|||||||||||ANCOVA||The Least Square Mean indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group.|||||
71153309|NCT00943072|141799019|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-6.6||||0.0059|TWO_SIDED|95.0|-12.2|-1.1|||Cochran-Mantel-Haenszel|CMH adjusted difference|The Risk Difference (RD) indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group. 95% confidence interval is for the RD.|||-1.1|-12.2|0.0059
71153310|NCT00943072|141799020|SUPERIORITY_OR_OTHER||Risk Difference (RD)|6.26||||0.0009|TWO_SIDED|95.0|2.61|9.91|||ANCOVA||The Risk Difference (RD) indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group. 95% confidence interval is for the RD.|||9.91|2.61|0.0009
71153311|NCT00943072|141799020|SUPERIORITY_OR_OTHER||Least Square Mean|8.8|||||||||||ANCOVA||Least Square Mean indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group.|||||
71153312|NCT00552188|141799021|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED|95.0|||||ANCOVA|||ANCOVA model adjusted for baseline value||||0.34
71153313|NCT00552188|141799022|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED|95.0|||||ANCOVA|||ANCOVA model adjusted for baseline||||0.15
71153314|NCT00689260|141799034|SUPERIORITY_OR_OTHER|||||||0.908||95.0|||||Wilcoxon (Mann-Whitney)|||P-Value based on two-sided Wilcoxon rank-sum test for difference in medians between log aware and log unaware||||0.908
71153315|NCT04857320|141799061|SUPERIORITY|||||||1.6e-05|||||||ANOVA|Degrees of Freedom = 5||Glucose was monitored by means of a wearable Continuous Glucose Monitor for several days prior to, during and post dosing. Measurements were gathered for each subject and averaged within-subject data. Our null hypothesis was that post prandial serum glucose would not vary significantly from their baseline values.||||0.000016
71153316|NCT04857320|141799062|SUPERIORITY|||||||0|||||||t-test, 1 sided|Degrees of Freedom = 3||Subject received doses applied to the skin of 0.075, 0.10 and 0.15 IUs / Kilogram on successive days. The Subject's average Serum Glucose for these 3 days were compared against the Subject's baseline unmedicated Serum Glucose on non-dosed days.||||0
71153317|NCT04857320|141799062|SUPERIORITY|||||||3e-06|||||||t-test, 1 sided|||Subject received doses applied to the skin of 0.075, 0.10 and 0.15 IUs / Kilogram on successive days. The Subject's average Serum Glucose for these 3 days were compared against the Subject's baseline unmedicated Serum Glucose on non-dosed days.||||0.000003
71153318|NCT04857320|141799062|SUPERIORITY|||||||2e-06|||||||t-test, 1 sided|Degrees of Freedom = 3||||||0.000002
71153319|NCT04857320|141799062|SUPERIORITY|||||||3.5e-05|||||||t-test, 1 sided|Degrees of Freedom = 3||||||0.000035
71153320|NCT04857320|141799062|SUPERIORITY|||||||4e-06|||||||t-test, 1 sided|Degrees of Freedom = 3||||||0.000004
71153321|NCT04857320|141799063|SUPERIORITY|||||||0|||||||ANOVA|||||||0
71153322|NCT01149148|141799067|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3333|STANDARD_DEVIATION|1.626||0.678|TWO_SIDED|95.0|-1.36|2.02||A prior threshold for statistical significance is p \< 0.05|t-test, 2 sided||The difference between baseline and three months is (baseline - 3 month). The difference in control and intervention is (intervention - control), which in this case is (unblinded - blinded).|The goal was to determine whether cerebral oximetry monitoring during surgery affected cognitive outcomes. Cerebral Oximetry Monitoring unblinded (intervention), and Cerebral Oxymetry Monitoring blinded (control) were given Mini Mental State Exam prior to surgery and three months after surgery. The differences between baseline and 3 month were calculated and compared between the intervention and control groups using t-test.||2.02|-1.36|0.678
71153323|NCT03436082|141799069|OTHER|We used Stata version 14.2 (StataCorp LP) to perform chi-square tests to compare syncing of the Fitbit device and response rate for the postprocedure recovery PROMs and disease-specific PROMs between patients in the bariatric surgery and atrial fibrillation ablation groups, using a p value \< 0.05 to denote statistical significance.||||||0.04|||||||Chi-squared|||||||0.04
71153324|NCT03436082|141799071|OTHER|We used Stata version 14.2 (StataCorp LP) to perform chi-square tests to compare syncing of the Fitbit device and response rate for the postprocedure recovery PROMs and disease-specific PROMs between patients in the bariatric surgery and atrial fibrillation ablation groups, using a p value \< 0.05 to denote statistical significance.||||||0.85|||||||Chi-squared|||||||0.85
71153325|NCT00950859|141799074|SUPERIORITY_OR_OTHER||percentage of participants|78.0|||||TWO_SIDED|95.0|58.0|91.0|||||The estimated value represents the percentage of participants with HIV-1 RNA \<400 c/mL or at least 0.7 log10 c/mL below their Baseline value at Day 11.|||91|58|
71091968|NCT01126424|141690519|SUPERIORITY_OR_OTHER||Least Square Mean Difference|9.152||||0.0505|TWO_SIDED|95.0|-0.023|18.326|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||18.326|-0.023|0.0505
71153326|NCT00950859|141799074|SUPERIORITY_OR_OTHER||percentage of participants|96.0||||||95.0|79.0|100.0|||||The estimated value represents the percentage of participants with HIV-1 RNA \<400 c/mL or at least 0.7 log10 c/mL below their Baseline value at Day 11.|||100|79|
71153327|NCT02917642|141799100|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that the irrigation protocol used after the chemo-mechanical preparation does not influence the reduction of bacteria within the root canal system.||||0.04
71153328|NCT02917642|141799101|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that the irrigation protocol used after the chemo-mechanical preparation does not influence the reduction of endotoxin within the root canal system.||||0.94
71153329|NCT02249832|141799102|EQUIVALENCE|A 3x3 repeated measures ANOVA was performed with group (mean gait speed in the low, moderate, and high groups) and time (admission, discharge (week 6), and follow-up (overall week 18) in each condition) as factors. Null hypothesis was that there was no difference in mean gait speed over time across the three groups. A significance level of 0.05 was used (two-sided).|||||<|0.001||||||A significance level of 0.05 was used (two-sided).|ANOVA|||||||<0.001
71153330|NCT02249832|141799103|EQUIVALENCE|A significance level of 0.05 was used (two-sided).|||||<|0.001|||||||ANOVA|||A 3x3 repeated measures ANOVA was performed with group (mean gait speed in the low, moderate, and high groups) and time (admission, discharge (week 6), and follow-up (overall week 18) in each condition) as factors. Null hypothesis was that there was no difference in mean gait speed over time across the three groups. A significance level of 0.05 was used (two-sided).||||<0.001
71153331|NCT02249832|141799104|EQUIVALENCE|A 3x3 repeated measures ANOVA was performed with group (mean distance walked in the low, moderate, and high groups) and time (admission, discharge (week 6), and follow-up (overall week 18) in each condition) as factors. Null hypothesis was that there was no difference in mean gait speed over time across the three groups. A significance level of 0.05 was used (two-sided).||||||0.001||||||A significance level of 0.05 was used (two-sided).|ANOVA|||||||0.001
71153332|NCT02563067|141799118|SUPERIORITY||Rate Ratio|0.69||||0.059|TWO_SIDED|95.0|0.5|0.96|||negative binomial regression model|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.96|0.50|0.059
71153333|NCT02563067|141799118|SUPERIORITY||Rate Ratio|0.72||||0.114|TWO_SIDED|95.0|0.52|1.01|||negative binomial regression model|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||1.01|0.52|0.114
71153334|NCT02563067|141799119|SUPERIORITY||Mean Difference (Net)|0.15||||0.369|TWO_SIDED|95.0|-0.02|0.32|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.32|-0.02|0.369
71153335|NCT02563067|141799119|SUPERIORITY||Mean Difference (Net)|0.13||||0.824|TWO_SIDED|95.0|-0.04|0.3|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.30|-0.04|0.824
71153336|NCT02563067|141799120|SUPERIORITY||Mean Difference (Net)|-0.17||||0.369|TWO_SIDED|95.0|-0.36|0.01|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.01|-0.36|0.369
71153337|NCT02563067|141799120|SUPERIORITY||Mean Difference (Net)|-0.09||||0.824|TWO_SIDED|95.0|-0.28|0.1|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.10|-0.28|0.824
71153338|NCT02563067|141799121|SUPERIORITY||Mean Difference (Net)|0.068||||0.369|TWO_SIDED|95.0|-0.018|0.154|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.154|-0.018|0.369
71153339|NCT02563067|141799121|SUPERIORITY||Mean Difference (Net)|0.038||||0.824|TWO_SIDED|95.0|-0.048|0.124|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.124|-0.048|0.824
71153340|NCT02563067|141799122|SUPERIORITY||Rate Ratio|0.82||||0.369|TWO_SIDED|95.0|0.62|1.07|||negative binomial regression model|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||1.07|0.62|0.369
71153341|NCT02563067|141799122|SUPERIORITY||Rate Ratio|0.76||||0.348|TWO_SIDED|95.0|0.58|1.0|||negative binomial regression model|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||1.00|0.58|0.348
71153342|NCT02563067|141799123|SUPERIORITY||Mean Difference (Net)|0.07||||0.824|TWO_SIDED|95.0|-0.07|0.21|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.21|-0.07|0.824
71153343|NCT02563067|141799123|SUPERIORITY||Mean Difference (Net)|0.12||||0.824|TWO_SIDED|95.0|-0.02|0.26|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.26|-0.02|0.824
71153344|NCT02563067|141799124|SUPERIORITY||Mean Difference (Net)|-0.12||||0.824|TWO_SIDED|95.0|-0.28|0.03|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.03|-0.28|0.824
71153345|NCT02563067|141799124|SUPERIORITY||Mean Difference (Net)|-0.07||||0.824|TWO_SIDED|95.0|-0.23|0.08|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.08|-0.23|0.824
70907281|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.19||0.0006|TWO_SIDED|95.0|-1.05|-0.3|||MMRM|||Anxiety Somatic, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.30|-1.05|0.0006
70969786|NCT03259074|141445131|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|Marginal difference|1.54|||||TWO_SIDED|95.0|-5.1|8.18|||||Estimated mean, marginal difference and 95% confidence interval are from a logistic regression model with treatment as a factor using marginal standardization method|||8.18|-5.10|
71153346|NCT02563067|141799125|SUPERIORITY||Mean Difference (Net)|0.05||||0.369|TWO_SIDED|95.0|-0.019|0.119|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.119|-0.019|0.369
71153347|NCT02563067|141799125|SUPERIORITY||Mean Difference (Net)|0.061||||0.595|TWO_SIDED|95.0|-0.008|0.13|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.130|-0.008|0.595
71153348|NCT00839319|141799127|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|Correlations between serum hormone levels and IT hormones, and between IT hormones were performed on 23 subjects in 4 groups using Spearmen technique.||||||<0.05
71153349|NCT01396447|141799170|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.1292|TWO_SIDED|95.0|-4.3|0.5||The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Repeated measures mixed-effects model||Cariprazine 0.75 mg vs Placebo|||0.5|-4.3|0.1292
71153350|NCT01396447|141799170|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.001|TWO_SIDED|95.0|-6.3|-1.6||The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Repeated measures mixed-effects model||Cariprazine 1.5 mg vs Placebo|||-1.6|-6.3|0.0010
71153351|NCT01396447|141799170|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.0374|TWO_SIDED|95.0|-4.9|-0.1||The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Repeated measures mixed-effects model||Cariprazine 3.0 mg vs Placebo|||-0.1|-4.9|0.0374
71153352|NCT01396447|141799171|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.3025|TWO_SIDED|95.0|-0.4|0.1|||Repeated measures mixed-effects model||Cariprazine 0.75 mg vs Placebo|The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.||0.1|-0.4|0.3025
71153353|NCT01396447|141799171|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.0044|TWO_SIDED|95.0|-0.6|-0.2|||Repeated measures mixed-effects model||Cariprazine 1.5 mg vs Placebo|The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.||-0.2|-0.6|0.0044
71153354|NCT01396447|141799171|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.0489|TWO_SIDED|95.0|-0.5|0.0|||Repeated measures mixed-effects model||Cariprazine 3.0 mg vs Placebo|The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.||-0.0|-0.5|0.0489
71153355|NCT00856518|141799194|SUPERIORITY_OR_OTHER|||||||0.899||||||EMST arm vs. Sham arm baseline MEP value comparison|Wilcoxon (Mann-Whitney)|||||||0.899
71153356|NCT00856518|141799194|SUPERIORITY_OR_OTHER|||||||0.946|||||||Plum Ordinal Regression Test|EMST arm vs. Sham arm group comparison of treatment response||||||0.946
71153357|NCT00856518|141799194|SUPERIORITY_OR_OTHER|||||||0.00042|||||||t-test, 2 sided|EMST arm post vs. pre-MEP comparison||||||0.00042
71153358|NCT00856518|141799194|SUPERIORITY_OR_OTHER|||||||0.0019||||||Sham arm post vs. pre-MEP comparison|t-test, 2 sided|||||||0.0019
71153359|NCT00856518|141799196|SUPERIORITY_OR_OTHER||||||>|0.05||||||EMST arm vs. Sham arm baseline total score and subscale score comparison|Wilcoxon (Mann-Whitney)|||||||> 0.05
71153360|NCT00856518|141799196|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Plum Ordinal Regression Test|EMST arm vs. Sham arm group comparison of treatment response for total score and all subscale scores except for Burden and Pharyngeal domains||||||> 0.05
71153361|NCT00856518|141799196|SUPERIORITY_OR_OTHER|||||||0.014|||||||Plum Ordinal Regression Test|EMST arm vs. Sham arm group comparison of treatment response in Burden domain||||||0.014
71153362|NCT00856518|141799196|SUPERIORITY_OR_OTHER|||||||0.022|||||||Plum Ordinal Regression test|EMST arm vs. Sham arm group comparison of treatment response in Pharyngeal domain||||||0.022
71153363|NCT00856518|141799196|SUPERIORITY_OR_OTHER||||||>|0.05||||||Sham arm post vs. pre-treatment comparison for the total SWAL-QOL score and subscale scores except for the Burden and Mental Health domains.|Wilcoxon Signed Ranks Test|||||||>0.05
71153364|NCT00856518|141799196|SUPERIORITY_OR_OTHER|||||||0.038|||||||Wilcoxon Signed Ranks Test|Sham arm post vs. pre-treatment comparison in Burden domain||||||0.038
71153365|NCT00856518|141799196|SUPERIORITY_OR_OTHER|||||||0.031|||||||Wilcoxon Signed Ranks Test|Sham arm post vs. pre-treatment comparison in Mental Health domain||||||0.031
71153366|NCT00856518|141799196|SUPERIORITY_OR_OTHER|||||||0.027|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Burden domain||||||0.027
71153367|NCT00856518|141799196|SUPERIORITY_OR_OTHER|||||||0.016|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Mental Health domain||||||0.016
71153368|NCT00856518|141799196|SUPERIORITY_OR_OTHER|||||||0.007|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Pharyngeal domain||||||0.007
71153369|NCT00856518|141799196|SUPERIORITY_OR_OTHER|||||||0.036|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Saliva domain||||||0.036
71153370|NCT00856518|141799196|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Fear domain||||||0.004
71153371|NCT00856518|141799196|SUPERIORITY_OR_OTHER|||||||0.016|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Total SWAL-QOL score||||||0.016
71153372|NCT02105961|141799208|SUPERIORITY||Rate ratio (Mepolizumab 100/Placebo)|0.8||||0.068|TWO_SIDED|95.0|0.65|0.98||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||0.98|0.65|0.068
71153373|NCT02105961|141799208|SUPERIORITY||Rate ratio (Mepolizumab 100/Placebo)|0.8||||0.034|TWO_SIDED|95.0|0.65|0.98||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||0.98|0.65|0.034
71153374|NCT02105961|141799208|SUPERIORITY||Rate ratio (Mepolizumab 300/Placebo)|0.86||||0.14|TWO_SIDED|95.0|0.7|1.05||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period|||1.05|0.70|0.140
71153375|NCT02105961|141799208|SUPERIORITY||Rate ratio (Mepolizumab 300/Placebo)|0.86||||0.14|TWO_SIDED|95.0|0.7|1.05||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||1.05|0.70|0.140
71153376|NCT02105961|141799209|SUPERIORITY||Hazard Ratio(Mepolizumab 100/Placebo)|0.82||||0.14|TWO_SIDED|95.0|0.64|1.04||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, number of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||1.04|0.64|0.140
71153377|NCT02105961|141799209|SUPERIORITY||Hazard Ratio (Mepolizumab/Placebo)|0.82||||0.103|TWO_SIDED|95.0|0.64|1.04||Unadjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, number of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||1.04|0.64|0.103
71153378|NCT02105961|141799209|SUPERIORITY||Hazard Ratio (Mepolizumab 300/Placebo)|0.77||||0.14|TWO_SIDED|95.0|0.6|0.97||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, number of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||0.97|0.60|0.140
71153379|NCT02105961|141799209|SUPERIORITY||Hazard Ratio (Mepolizumab 300/Placebo)|0.77||||0.03|TWO_SIDED|95.0|0.6|0.97||Unadjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, number of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||0.97|0.60|0.030
71153380|NCT02105961|141799210|SUPERIORITY||Rate ratio (Mepolizumab 100/Placebo)|0.59||||0.14|TWO_SIDED|95.0|0.35|0.98||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||0.98|0.35|0.140
71153381|NCT02105961|141799210|SUPERIORITY||Rate ratio (Mepolizumab 100/Placebo)|0.59||||0.042|TWO_SIDED|95.0|0.35|0.98||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||0.98|0.35|0.042
71153382|NCT02105961|141799210|SUPERIORITY||Rate ratio (Mepolizumab 300/Placebo)|0.83||||0.447|TWO_SIDED|95.0|0.51|1.34||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||1.34|0.51|0.447
71153383|NCT02105961|141799210|SUPERIORITY||Rate ratio (Mepolizumab 300/Placebo)|0.83||||0.447|TWO_SIDED|95.0|0.51|1.34||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||1.34|0.51|0.447
71153384|NCT02105961|141799211|SUPERIORITY||Mean difference(Mepolizumab 100-Placebo)|-1.8||||0.447|TWO_SIDED|95.0|-4.5|0.8||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline SGRQ total score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.8|-4.5|0.447
71153385|NCT02105961|141799211|SUPERIORITY||Mean difference(Mepolizumab 100-Placebo)|-1.8||||0.18|TWO_SIDED|95.0|-4.5|0.8||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline SGRQ total score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.8|-4.5|0.180
71153386|NCT02105961|141799211|SUPERIORITY||Mean difference(Mepolizumab 300-Placebo)|-0.1||||0.926|TWO_SIDED|95.0|-2.8|2.6||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline SGRQ total score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||2.6|-2.8|0.926
70907282|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.185||0.0415|TWO_SIDED|95.0|-0.75|-0.01|||MMRM|||Anxiety Somatic, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.75|0.0415
70907283|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.193||0.0581|TWO_SIDED|95.0|-0.75|0.01|||MMRM|||Anxiety Somatic, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.75|0.0581
70907284|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.188||0.6826|TWO_SIDED|95.0|-0.45|0.3|||MMRM|||Anxiety Somatic, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.45|0.6826
70907285|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.226||0.0912|TWO_SIDED|95.0|-0.83|0.06|||MMRM|||Anxiety Somatic, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.83|0.0912
70969787|NCT03259074|141445132|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|Marginal difference|-2.34|||||TWO_SIDED|95.0|-10.18|5.51|||||Estimated mean, marginal difference and 95% confidence interval are from a logistic regression model with treatment as a factor using marginal standardization method.|||5.51|-10.18|
70969788|NCT03259074|141445133|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented|Marginal difference|2.18|||||TWO_SIDED|95.0|-5.34|9.69|||Marginal difference||Estimated mean, marginal difference and 95% confidence interval are from a logistic regression model with treatment as a factor using marginal standardization method|||9.69|-5.34|
71153387|NCT02105961|141799211|SUPERIORITY||Mean difference(Mepolizumab 300-Placebo)|-0.1||||0.926|TWO_SIDED|95.0|-2.8|2.6||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline SGRQ total score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||2.6|-2.8|0.926
71153388|NCT02105961|141799212|SUPERIORITY||Mean difference(Mepolizumab 100-Placebo)|-1.1||||0.926|TWO_SIDED|95.0|-2.3|0.0||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.0|-2.3|0.926
71153389|NCT02105961|141799212|SUPERIORITY||Mean difference(Mepolizumab 100-Placebo)|-1.1||||0.055|TWO_SIDED|95.0|-2.3|0.0||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.0|-2.3|0.055
71153390|NCT02105961|141799212|SUPERIORITY||Mean difference(Mepolizumab 300-Placebo)|-0.4||||0.926|TWO_SIDED|95.0|-1.5|0.8||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.8|-1.5|0.926
71153391|NCT02105961|141799212|SUPERIORITY||Mean difference(Mepolizumab 300-Placebo)|-0.4||||0.547|TWO_SIDED|95.0|-1.5|0.8||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.8|-1.5|0.547
71153392|NCT01485172|141799215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.864|TWO_SIDED|95.0|-3.41|4.05||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||4.05|-3.41|0.864
71153393|NCT01485172|141799215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||0.539|TWO_SIDED|95.0|-3.61|1.9||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||1.90|-3.61|0.539
71153394|NCT01485172|141799215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.091|TWO_SIDED|95.0|-5.21|0.39||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.39|-5.21|0.091
71153395|NCT01485172|141799215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.16||||0.124|TWO_SIDED|95.0|-4.93|0.6||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.60|-4.93|0.124
71153396|NCT01485172|141799215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||0.658|TWO_SIDED|95.0|-5.04|3.19||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||3.19|-5.04|0.658
71153397|NCT01485172|141799215|SUPERIORITY_OR_OTHER|||||||0.439||95.0||||P-values are from nonparametric rank ANCOVA without stratifications.|ANCOVA|||||||0.439
71153398|NCT01485172|141799215|SUPERIORITY_OR_OTHER|||||||0.177||95.0||||P-values are from nonparametric rank ANCOVA without stratifications.|ANCOVA|||||||0.177
71153399|NCT01485172|141799215|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||P-values are from nonparametric rank ANCOVA without stratifications.|ANCOVA|||||||0.060
71153400|NCT01485172|141799215|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-values are from nonparametric rank ANCOVA without stratifications.|ANCOVA|||||||0.047
71153401|NCT01485172|141799215|SUPERIORITY_OR_OTHER|||||||0.407||95.0||||P-values are from nonparametric rank ANCOVA without stratifications.|ANCOVA|||||||0.407
71153402|NCT01485172|141799216|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.003||||0.397|TWO_SIDED|95.0|0.4|9.98|||Generalized Estimating Equations model|||||9.98|0.40|0.397
71153403|NCT01485172|141799216|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.242||||0.131|TWO_SIDED|95.0|0.79|6.4|||Generalized Estimating Equations model|||||6.40|0.79|0.131
71153404|NCT01485172|141799216|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.515||||0.018|TWO_SIDED|95.0|1.25|9.92|||Generalized Estimating Equations model|||||9.92|1.25|0.018
71153405|NCT01485172|141799216|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.607||||0.02||95.0|1.22|10.64|||Generalized Estimating Equations model|||||10.64|1.22|0.020
71153406|NCT01485172|141799216|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.679||||0.202|TWO_SIDED|95.0|0.59|12.16|||Generalized Estimating Equations model|||||12.16|0.59|0.202
71153407|NCT01485172|141799217|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.544||||0.662||95.0|0.22|10.84|||Generalized Estimating Equations model|||||10.84|0.22|0.662
71153408|NCT01485172|141799217|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.485||||0.557|TWO_SIDED|95.0|0.4|5.55|||Generalized Estimating Equations model|||||5.55|0.40|0.557
71153409|NCT01485172|141799217|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.855||||0.347|TWO_SIDED|95.0|0.51|6.72|||Generalized Estimating Equations model|||||6.72|0.51|0.347
71153410|NCT01485172|141799217|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.776||||0.379|TWO_SIDED|95.0|0.49|6.38|||Generalized Estimating Equations model|||||6.38|0.49|0.379
71153411|NCT01485172|141799217|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.194||||0.851|TWO_SIDED|95.0|0.19|7.63|||Generalized Estimating Equations model|||||7.63|0.19|0.851
71153412|NCT01485172|141799219|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.591||||0.54|TWO_SIDED|95.0|0.36|7.03|||Generalized Estimating Equations model|||||7.03|0.36|0.540
71153413|NCT01485172|141799219|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.473||||0.494|TWO_SIDED|95.0|0.49|4.47|||Generalized Estimating Equations model|||||4.47|0.49|0.494
71153414|NCT01485172|141799219|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.391||||0.115|TWO_SIDED|95.0|0.81|7.06|||Generalized Estimating Equations model|||||7.06|0.81|0.115
71153415|NCT01485172|141799219|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.96||||0.045|TWO_SIDED|95.0|1.02|8.55|||Generalized Estimating Equations model|||||8.55|1.02|0.045
71153416|NCT01485172|141799219|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.506||||0.221|TWO_SIDED|95.0|0.58|10.9|||Generalized Estimating Equations model|||||10.90|0.58|0.221
71153417|NCT01485172|141799220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07||||0.662|TWO_SIDED|95.0|-3.78|5.93||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||5.93|-3.78|0.662
71153418|NCT01485172|141799220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93||||0.621|TWO_SIDED|95.0|-4.63|2.77||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||2.77|-4.63|0.621
71153419|NCT01485172|141799220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.75||||0.15|TWO_SIDED|95.0|-6.5|1.01||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||1.01|-6.50|0.150
71153420|NCT01485172|141799220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.74||||0.048|TWO_SIDED|95.0|-7.43|-0.04||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||-0.04|-7.43|0.048
71153421|NCT01485172|141799220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||0.715|TWO_SIDED|95.0|-6.32|4.35||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||4.35|-6.32|0.715
71153422|NCT01485172|141799221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17||||0.158|TWO_SIDED|95.0|-0.46|2.81||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||2.81|-0.46|0.158
71153423|NCT01485172|141799221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.446|TWO_SIDED|95.0|-1.71|0.76||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.76|-1.71|0.446
71153424|NCT01485172|141799221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87||||0.163|TWO_SIDED|95.0|-2.1|0.36||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.36|-2.10|0.163
71153425|NCT01485172|141799221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.117|TWO_SIDED|95.0|-2.27|0.25||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.25|-2.27|0.117
71153426|NCT01485172|141799221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73||||0.456|TWO_SIDED|95.0|-2.67|1.2||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||1.20|-2.67|0.456
71153427|NCT01485172|141799222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56||||0.823|TWO_SIDED|95.0|-4.38|5.5||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||5.50|-4.38|0.823
71153428|NCT01485172|141799222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09||||0.568|TWO_SIDED|95.0|-4.86|2.68||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||2.68|-4.86|0.568
71153429|NCT01485172|141799222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.19||||0.101|TWO_SIDED|95.0|-7.01|0.63||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.63|-7.01|0.101
71153430|NCT01485172|141799222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.94||||0.04|TWO_SIDED|95.0|-7.7|-0.18||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||-0.18|-7.70|0.040
71153431|NCT01485172|141799222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.811|TWO_SIDED|95.0|-6.08|4.77||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||4.77|-6.08|0.811
71153432|NCT01485172|141799223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.102|TWO_SIDED|95.0|-0.86|0.08||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.08|-0.86|0.102
71153433|NCT01485172|141799223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.723|TWO_SIDED|95.0|-0.41|0.29||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.29|-0.41|0.723
71153434|NCT01485172|141799223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.084|TWO_SIDED|95.0|-0.66|0.04||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.04|-0.66|0.084
71153435|NCT01485172|141799223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.697|TWO_SIDED|95.0|-0.42|0.28||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.28|-0.42|0.697
71153436|NCT01485172|141799223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.086|TWO_SIDED|95.0|-0.06|0.97||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.97|-0.06|0.086
71153437|NCT01485172|141799224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.769||||0.733|TWO_SIDED|95.0|0.17|3.49|||Generalized Estimating Equations model|||||3.49|0.17|0.733
71153438|NCT01485172|141799224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.411||||0.519|TWO_SIDED|95.0|0.5|4.02|||Generalized Estimating Equations model|||||4.02|0.50|0.519
71153439|NCT01485172|141799224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.204||||0.008|TWO_SIDED|95.0|1.46|12.07|||Generalized Estimating Equations model|||||12.07|1.46|0.008
71153440|NCT01485172|141799224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.456||||0.001|TWO_SIDED|95.0|1.93|15.46|||Generalized Estimating Equations model|||||15.46|1.93|0.001
71153441|NCT01485172|141799224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.281||||0.752|TWO_SIDED|95.0|0.27|5.98|||Generalized Estimating Equations model|||||5.98|0.27|0.752
70907286|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.218||0.3988|TWO_SIDED|95.0|-0.62|0.25|||MMRM|||Anxiety Somatic, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.62|0.3988
71153442|NCT00838513|141799303|SUPERIORITY_OR_OTHER||Percent of TMA event-free responders|80.0|||||TWO_SIDED|95.0|56.0|94.0||||||"With a total of 20 patients enrolled between both protocols and, assuming that the true expected probability of TMA Event-Free for eculizumab-treated patients is 40%, then the study had 93.5% power to detect a statistically significant difference. Up to approximately 30 patients were to be enrolled.~All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS."||94|56|
71153443|NCT00838513|141799304|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||99|68|
71153444|NCT00838513|141799305|SUPERIORITY_OR_OTHER||Percent of complete TMA response|25.0|||||TWO_SIDED|95.0|9.0|49.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||49|9|
71153445|NCT00838513|141799306|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.29|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||||<0.0001
71153446|NCT00838513|141799307|SUPERIORITY_OR_OTHER||LS mean change from baseline|6.75||||0.5423|TWO_SIDED|95.0|-15.73|29.23|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years||29.23|-15.73|0.5423
71153447|NCT00838513|141799308|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years||99|68|
71153448|NCT00838513|141799309|SUPERIORITY_OR_OTHER||Percent of TMA event-free responders|95.0|||||TWO_SIDED|95.0|75.0|100.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||100|75|
71153449|NCT00838513|141799310|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||99|68|
71153450|NCT00838513|141799311|SUPERIORITY_OR_OTHER||Percent of complete TMA response|55.0|||||TWO_SIDED|95.0|32.0|77.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||77|32|
71153451|NCT00838513|141799312|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.29|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||||<0.0001
70907287|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.231||0.0504|TWO_SIDED|95.0|-0.91|0.0|||MMRM|||Anxiety Somatic, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.91|0.0504
70907288|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.22||0.6019|TWO_SIDED|95.0|-0.55|0.32|||MMRM|||Anxiety Somatic, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.55|0.6019
70907289|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.222||0.007|TWO_SIDED|95.0|-1.05|-0.17|||MMRM|||Anxiety Somatic, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.17|-1.05|0.0070
70907290|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.218||0.3785|TWO_SIDED|95.0|-0.62|0.24|||MMRM|||Anxiety Somatic, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.62|0.3785
70907291|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.159||0.9609|TWO_SIDED|95.0|-0.32|0.31|||MMRM|||Somatic Symptoms GI, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.32|0.9609
70907292|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.154||0.9183|TWO_SIDED|95.0|-0.32|0.29|||MMRM|||Somatic Symptoms GI, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.32|0.9183
70907293|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.149||0.071|TWO_SIDED|95.0|-0.57|0.02|||MMRM|||Somatic Symptoms GI, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.57|0.0710
70907294|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.143||0.2607|TWO_SIDED|95.0|-0.45|0.12|||MMRM|||Somatic Symptoms GI, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.45|0.2607
70907295|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.158||0.2466|TWO_SIDED|95.0|-0.5|0.13|||MMRM|||Somatic Symptoms GI, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.50|0.2466
70907296|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.153||0.3461|TWO_SIDED|95.0|-0.45|0.16|||MMRM|||Somatic Symptoms GI, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.45|0.3461
70907297|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.162||0.0919|TWO_SIDED|95.0|-0.6|0.05|||MMRM|||Somatic Symptoms GI, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.60|0.0919
70907298|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.157||0.7554|TWO_SIDED|95.0|-0.36|0.26|||MMRM|||Somatic Symptoms GI, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.36|0.7554
71153452|NCT00838513|141799313|SUPERIORITY_OR_OTHER||LS mean change from baseline|-3.68||||0.7307|TWO_SIDED|95.0|-25.15|17.79|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||17.79|-25.15|0.7307
71153453|NCT00838513|141799314|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years||99|68|
71153454|NCT00573144|141799328|SUPERIORITY_OR_OTHER|||||||0.97|||||||t-test, 2 sided|||||||0.97
71153455|NCT00573144|141799329|SUPERIORITY_OR_OTHER|||||||0.35|||||||t-test, 2 sided|||||||0.35
71153456|NCT00573144|141799330|SUPERIORITY_OR_OTHER|||||||0.26|||||||t-test, 2 sided|||||||0.26
71153457|NCT03001817|141799338|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71153458|NCT03001817|141799339|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71153459|NCT03001817|141799340|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann Method|||||||<0.0001
71153460|NCT03001817|141799341|SUPERIORITY|||||||0.5443|||||||Hodges-Lehmann method|||||||0.5443
71153461|NCT03001817|141799342|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann Method|||||||<0.0001
71153462|NCT03001817|141799343|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71153463|NCT03001817|141799344|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71153464|NCT03001817|141799345|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71153465|NCT03001817|141799346|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71153466|NCT03001817|141799347|SUPERIORITY|||||||0.4939|||||||Hodges-Lehmann method|||||||0.4939
71153467|NCT03001817|141799348|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71153468|NCT03001817|141799349|SUPERIORITY|||||||0.8371|||||||Hodges-Lehmann method|||||||0.8371
71153469|NCT03001817|141799350|SUPERIORITY|||||||0.3415|||||||Hodges-Lehmann method|||||||0.3415
71153470|NCT03001817|141799351|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71153471|NCT03001817|141799352|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71153472|NCT03001817|141799353|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71153473|NCT03001817|141799354|SUPERIORITY|||||||0.7442|||||||Hodges-Lehmann method|||||||0.7442
71153474|NCT03001817|141799355|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71153475|NCT03001817|141799356|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71153476|NCT03001817|141799357|SUPERIORITY|||||||0.0374|||||||Hodges-Lehmann method|||||||0.0374
71153477|NCT03001817|141799358|SUPERIORITY|||||||0.7429|||||||Hodges-Lehmann method|||||||0.7429
71153478|NCT03001817|141799359|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71153479|NCT03001817|141799360|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71153480|NCT03001817|141799361|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71153481|NCT03001817|141799362|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71153482|NCT03001817|141799363|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71153483|NCT03001817|141799364|SUPERIORITY|||||||0.3669|||||||Hodges-Lehmann method|||||||0.3669
71153484|NCT03001817|141799365|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71153485|NCT03001817|141799366|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71153486|NCT03001817|141799367|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71153487|NCT03001817|141799368|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71153488|NCT03001817|141799369|SUPERIORITY|||||||0.0509|||||||Hodges-Lehmann method|||||||0.0509
71153489|NCT03001817|141799370|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71153490|NCT03001817|141799371|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71153491|NCT03001817|141799372|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71153492|NCT03001817|141799373|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71153493|NCT03001817|141799374|SUPERIORITY|||||||0.0647|||||||Hodges-Lehmann method|||||||0.0647
71153494|NCT03001817|141799375|SUPERIORITY|||||||0.0007|||||||Hodges-Lehmann method|||||||0.0007
71153495|NCT03001817|141799376|SUPERIORITY|||||||0.1399|||||||Hodges-Lehmann method|||||||0.1399
71153496|NCT03001817|141799377|SUPERIORITY|||||||0.0122|||||||Hodges-Lehmann method|||||||0.0122
71153497|NCT03001817|141799378|SUPERIORITY|||||||0.0994|||||||Hodges-Lehmann method|||||||0.0994
71153498|NCT03001817|141799379|SUPERIORITY|||||||0.0904|||||||Hodges-Lehmann method|||||||0.0904
71153499|NCT03001817|141799380|SUPERIORITY|||||||0.4346|||||||non-parametric Hodges-Lehmann method|||||||0.4346
71153500|NCT03001817|141799381|SUPERIORITY|||||||0.1474|||||||non-parametric Hodges-Lehmann method|||||||0.1474
71153501|NCT03001817|141799382|SUPERIORITY|||||||0.0054|||||||non-parametric Hodges-Lehmann method|||||||0.0054
71153502|NCT03001817|141799383|SUPERIORITY|||||||0.0002|||||||Hodges-Lehmann method|||||||0.0002
71153503|NCT03001817|141799384|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71153504|NCT03001817|141799385|SUPERIORITY|||||||0.0118|||||||Hodges-Lehmann method|||||||0.0118
71153505|NCT03001817|141799386|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71153506|NCT03001817|141799387|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71153507|NCT03001817|141799388|SUPERIORITY|||||||0.2049|||||||Hodges-Lehmann method|||||||0.2049
71153508|NCT03001817|141799389|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71153509|NCT03001817|141799390|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71153510|NCT03001817|141799391|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71153511|NCT03001817|141799392|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71153512|NCT03001817|141799393|SUPERIORITY|||||||0.9117|||||||Hodges-Lehmann method|||||||0.9117
71153513|NCT03001817|141799394|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71153514|NCT00035932|141799452|NON_INFERIORITY_OR_EQUIVALENCE|The time-averaged difference (TAD) in the reduction of log10 HIV RNA levels from baseline through Week 24 was compared pairwise for each atazanavir regimen to the lopinavir/RTV regimen, and assessed using a two-sided 97.5% confidence interval. The primary efficacy analysis was to declare two treatment regimens similar if the upper limit of this 97.5% confidence interval for the difference (atazanavir-lopinavir/RTV) was less than 0.5 log10.|Time-Averaged Difference|0.14|||||TWO_SIDED|97.5|-0.09|0.37||||||||0.37|-0.09|
71153515|NCT00035932|141799452|NON_INFERIORITY_OR_EQUIVALENCE|The time-averaged difference (TAD) in the reduction of log10 HIV RNA levels from baseline through Week 24 was compared pairwise for each atazanavir regimen to the lopinavir/RTV regimen, and assessed using a two-sided 97.5% confidence interval. The primary efficacy analysis was to declare two treatment regimens similar if the upper limit of this 97.5% confidence interval for the difference (atazanavir-lopinavir/RTV) was less than 0.5 log10.|Time-Averaged Difference|0.31|||||TWO_SIDED|97.5|0.07|0.55||||||||0.55|0.07|
71153516|NCT00035932|141799453|SUPERIORITY_OR_OTHER||Treatment Difference|0.13|||||TWO_SIDED|95.0|-0.04|0.3||||||||0.30|-0.04|
71153517|NCT00035932|141799453|SUPERIORITY_OR_OTHER||Treatment Difference|0.17|||||TWO_SIDED|95.0|-0.01|0.35||||||||0.35|-0.01|
71153518|NCT00035932|141799456|SUPERIORITY_OR_OTHER||Time-Averaged Difference|0.13|||||TWO_SIDED|97.5|-0.12|0.39||||||||0.39|-0.12|
71153519|NCT00035932|141799456|SUPERIORITY_OR_OTHER||Time-Averaged Distance|0.33|||||TWO_SIDED|97.5|0.07|0.6||||||||0.60|0.07|
71153520|NCT00035932|141799457|SUPERIORITY_OR_OTHER||Difference estimate|-0.5|||||TWO_SIDED|95.0|-13.3|12.3|||||ATV 300/RTV - LPV/RTV|Randomized participants||12.3|-13.3|
71153521|NCT00035932|141799458|SUPERIORITY_OR_OTHER||Difference Estimate|3.6|||||TWO_SIDED|95.0|-7.0|14.1||||||||14.1|-7.0|
71153522|NCT00035932|141799458|SUPERIORITY_OR_OTHER||Difference Estimate|-11.3|||||TWO_SIDED|95.0|-22.9|0.4||||||||0.4|-22.9|
71153523|NCT00035932|141799460|SUPERIORITY_OR_OTHER||Difference Estimate|-5.0|||||TWO_SIDED|95.0|-16.9|7.0||||||||7.0|-16.9|
71153524|NCT00035932|141799460|SUPERIORITY_OR_OTHER||Difference Estimate|-16.1|||||TWO_SIDED|95.0|-28.5|-3.7||||||||-3.7|-28.5|
71153525|NCT00035932|141799462|SUPERIORITY_OR_OTHER||Difference Estimate|0.4|||||TWO_SIDED|95.0|-12.5|13.2|||||ATV 300/RTV - LPV/RTV|||13.2|-12.5|
71153526|NCT00035932|141799463|SUPERIORITY_OR_OTHER||Difference Estimate|3.2|||||TWO_SIDED|95.0|-9.1|15.4||||||||15.4|-9.1|
71153527|NCT00035932|141799463|SUPERIORITY_OR_OTHER||Difference Estimate|-16.7|||||TWO_SIDED|95.0|-29.4|-4.0||||||||-4.0|-29.4|
71153528|NCT00035932|141799464|SUPERIORITY_OR_OTHER||Difference Estimate|-1.1|||||TWO_SIDED|95.0|-13.7|11.4||||||||11.4|-13.7|
71153529|NCT00035932|141799464|SUPERIORITY_OR_OTHER||Difference Estimate|-17.9|||||TWO_SIDED|95.0|-30.6|-5.3||||||||-5.3|-30.6|
71153530|NCT00035932|141799465|SUPERIORITY_OR_OTHER||Difference Estimate|-2.4|||||TWO_SIDED|95.0|-15.0|10.3|||Chi-squared, Corrected||ATV 300/RTV - LPV/RTV|||10.3|-15.0|
71153531|NCT00035932|141799466|SUPERIORITY_OR_OTHER||Difference Estimate|-2.3|||||TWO_SIDED|95.0|-14.6|10.0||||||||10.0|-14.6|
71153532|NCT00035932|141799466|SUPERIORITY_OR_OTHER||Difference Estimate|-18.9|||||TWO_SIDED|95.0|-30.7|-7.1||||||||-7.1|-30.7|
71153533|NCT00035932|141799467|SUPERIORITY_OR_OTHER||Difference Estimate|-6.4|||||TWO_SIDED|95.0|-18.7|5.8||||||||5.8|-18.7|
70907299|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.166||0.015|TWO_SIDED|95.0|-0.74|-0.08|||MMRM|||Somatic Symptoms GI, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.08|-0.74|0.0150
70907300|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.16||0.0482|TWO_SIDED|95.0|-0.64|0.0|||MMRM|||Somatic Symptoms GI, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.64|0.0482
70907301|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.163||0.0003|TWO_SIDED|95.0|-0.93|-0.28|||MMRM|||Somatic Symptoms GI, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.28|-0.93|0.0003
70907302|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.156||0.1182|TWO_SIDED|95.0|-0.56|0.06|||MMRM|||Somatic Symptoms GI, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.56|0.1182
70969789|NCT03259074|141445134|OTHER||Marginal difference|0.33|||||TWO_SIDED|95.0|-7.08|7.74||Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|||Estimated mean, marginal difference and 95% confidence interval are from a logistic regression model with treatment as a factor using marginal standardization method|||7.74|-7.08|
70969790|NCT02409290|141445161|SUPERIORITY||Cox Proportional Hazard|0.2||||0.0016|TWO_SIDED|95.0|0.07|0.61|||Log Rank|||||0.61|0.07|0.0016
70969791|NCT02409290|141445162|SUPERIORITY||Cox Proportional Hazard|0.11||||0.0005|TWO_SIDED|95.0|0.03|0.5|||Log Rank|||Control regimen (arm B) uses concurrent controls only||0.50|0.03|0.0005
71153534|NCT00035932|141799467|SUPERIORITY_OR_OTHER||Difference Estimate|-17.9|||||TWO_SIDED|95.0|-29.9|-5.9||||||||-5.9|-29.9|
71153535|NCT00035932|141799469|SUPERIORITY_OR_OTHER||Time-Averaged Difference|-18.4|||||TWO_SIDED|97.5|-44.3|7.5||||||||7.5|-44.3|
71153536|NCT00035932|141799469|SUPERIORITY_OR_OTHER||Time-Averaged Difference|-44.9|||||TWO_SIDED|97.5|-74.5|-15.3||||||||-15.3|-74.5|
71153537|NCT00035932|141799470|SUPERIORITY_OR_OTHER||Time-Averaged Difference|-17.5|||||TWO_SIDED|97.5|-45.6|10.6||||||||10.6|-45.6|
71153538|NCT00035932|141799470|SUPERIORITY_OR_OTHER||Time-Averaged Difference|-47.6|||||TWO_SIDED|97.5|-79.2|-16.1||||||||-16.1|-79.2|
71153539|NCT00035932|141799472|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||P-value was based on a t-distribution.|t-test, 1 sided|||Correlation between IQ (\<10; \>=10) of ATV 300 mg / RTV and HIV RNA||||<0.05
71153540|NCT00035932|141799472|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||P-value was based on a t-distribution.|t-test, 1 sided|||Correlation between number of PI Mutations at baseline (\<4; \>=4) of ATV 400 mg / SQV and HIV RNA||||<0.05
71153541|NCT00035932|141799474|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||P-value was based on a t-distribution.|t-test, 1 sided|||Correlation between ATV Cmin of ATV 300 mg / RTV and CD4 Cell Count||||<0.05
71153542|NCT00035932|141799474|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||P-value was based on a t-distribution.|t-test, 1 sided|||Correlation between IQ (\<10; \>=10) of ATV 300 mg / RTV and CD4 Cell Count||||<0.05
71153543|NCT00035932|141799474|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||P-value was based on a t-distribution.|t-test, 1 sided|||Correlation between # of PI Mutations at baseline (\<4; \>=4) of ATV 300 mg / RTV and CD4 Cell Count||||<0.05
71153544|NCT00035932|141799476|SUPERIORITY_OR_OTHER||Difference Estimate|-10.9|||||TWO_SIDED|95.0|-15.5|-6.0||||||Total Cholesterol||-6.0|-15.5|
71153545|NCT00035932|141799476|SUPERIORITY_OR_OTHER||Difference Estimate|-12.4|||||TWO_SIDED|95.0|-16.9|-7.6||||||Total Cholesterol||-7.6|-16.9|
71153546|NCT00035932|141799476|SUPERIORITY_OR_OTHER||Difference Estimate|-6.7|||||TWO_SIDED|95.0|-13.6|0.7||||||HDL cholesterol||0.7|-13.6|
71153547|NCT00035932|141799476|SUPERIORITY_OR_OTHER||Difference Estimate|-1.0|||||TWO_SIDED|95.0|-9.3|8.1||||||HDL Cholesterol||8.1|-9.3|
71153548|NCT00035932|141799476|SUPERIORITY_OR_OTHER||Difference Estimate|-6.8|||||TWO_SIDED|95.0|-15.6|3.0||||||Fasting LDL Cholesterol||3.0|-15.6|
71153549|NCT00035932|141799476|SUPERIORITY_OR_OTHER||Difference Estimate|-7.3|||||TWO_SIDED|95.0|-15.5|1.8||||||Fasting LDL Cholesterol||1.8|-15.5|
70907303|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.159||0.0008|TWO_SIDED|95.0|-0.87|-0.24|||MMRM|||Somatic Symptoms GI, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.24|-0.87|0.0008
70907304|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.154||0.1379|TWO_SIDED|95.0|-0.54|0.08|||MMRM|||Somatic Symptoms GI, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.54|0.1379
70907305|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.145||0.004|TWO_SIDED|95.0|-0.71|-0.14|||MMRM|||Somatic Symptoms GI, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.14|-0.71|0.0040
70907306|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.14||0.31|TWO_SIDED|95.0|-0.42|0.14|||MMRM|||Somatic Symptoms GI, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.42|0.3100
70907307|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.148||0.0003|TWO_SIDED|95.0|-0.85|-0.26|||MMRM|||Somatic Symptoms GI, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.26|-0.85|0.0003
70907308|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.143||0.0223|TWO_SIDED|95.0|-0.61|-0.05|||MMRM|||Somatic Symptoms GI, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.05|-0.61|0.0223
70907309|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.166||0.0276|TWO_SIDED|95.0|-0.7|-0.04|||MMRM|||Somatic Symptoms GI, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.04|-0.70|0.0276
70907310|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.161||0.8516|TWO_SIDED|95.0|-0.35|0.29|||MMRM|||Somatic Symptoms GI, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.35|0.8516
70907311|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.186||0.1669|TWO_SIDED|95.0|-0.63|0.11|||MMRM|||Somatic Symptoms GI, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.63|0.1669
70907312|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.18||0.4935|TWO_SIDED|95.0|-0.48|0.23|||MMRM|||Somatic Symptoms GI, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.48|0.4935
70907313|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.197||0.0202|TWO_SIDED|95.0|-0.86|-0.07|||MMRM|||Somatic Symptoms GI, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.07|-0.86|0.0202
70907314|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.188||0.2683|TWO_SIDED|95.0|-0.58|0.16|||MMRM|||Somatic Symptoms GI, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.58|0.2683
70969792|NCT00708500|141445163|SUPERIORITY_OR_OTHER||Treatment Difference|37.4|||<|0.0001||95.0|25.7|49.1|||Cochran-Mantel-Haenszel||Difference in percentage of participants who achieved SVR: experimental minus control.|||49.1|25.7|<0.0001
71153550|NCT00035932|141799476|SUPERIORITY_OR_OTHER||Difference Estimate|-24.9|||||TWO_SIDED|95.0|-35.0|-13.2||||||Fasting Triglycerides||-13.2|-35.0|
71153551|NCT00035932|141799476|SUPERIORITY_OR_OTHER||Difference Estimate|-34.2|||||TWO_SIDED|95.0|-43.4|-23.4||||||Fasting Triglycerides||-23.4|-43.4|
71153552|NCT00035932|141799477|SUPERIORITY_OR_OTHER||Difference Estimate|-12.1|||||TWO_SIDED|95.0|-17.0|-7.2||||||Total Cholesterol||-7.2|-17.0|
71153553|NCT00035932|141799477|SUPERIORITY_OR_OTHER||Difference Estimate|-12.0|||||TWO_SIDED|95.0|-17.4|-6.5||||||Total Cholesterol||-6.5|-17.4|
71153554|NCT00035932|141799477|SUPERIORITY_OR_OTHER||Difference Estimate|-4.4|||||TWO_SIDED|95.0|-12.4|3.5||||||HDL Cholesterol||3.5|-12.4|
71153555|NCT00035932|141799477|SUPERIORITY_OR_OTHER||DIfference Estimate|-0.8|||||TWO_SIDED|95.0|-11.0|9.3||||||HDL Cholesterol||9.3|-11.0|
71153556|NCT00035932|141799477|SUPERIORITY_OR_OTHER||Difference Estimate|-8.9|||||TWO_SIDED|95.0|-19.0|1.2||||||Fasting LDL CHolesterol||1.2|-19.0|
71153557|NCT00035932|141799477|SUPERIORITY_OR_OTHER||Difference Estimate|-7.4|||||TWO_SIDED|95.0|-17.7|3.0||||||Fasting LDL Cholesterol||3.0|-17.7|
71153558|NCT00035932|141799477|SUPERIORITY_OR_OTHER||Difference Estimate|-29.6|||||TWO_SIDED|95.0|-41.6|-17.7||||||Fasting Triglycerides||-17.7|-41.6|
71153559|NCT00035932|141799477|SUPERIORITY_OR_OTHER||Difference Estimate|-38.4|||||TWO_SIDED|95.0|-49.7|-27.1||||||Fasting Triglycerides||-27.1|-49.7|
71153560|NCT00035932|141799478|SUPERIORITY_OR_OTHER||Difference Estimate|-14.4|||||TWO_SIDED|95.0|-20.1|-8.3|||||ATV 300/RTV - LPV/RTV|Observed values, Total Cholesterol||-8.3|-20.1|
71153561|NCT00035932|141799478|SUPERIORITY_OR_OTHER||Difference Estimate|-9.0|||||TWO_SIDED|95.0|-16.1|-1.3|||||ATV 400/SQV - LPV/RTV|observed values, total cholesterol||-1.3|-16.1|
71153562|NCT00035932|141799478|SUPERIORITY_OR_OTHER||Difference Estimate|-11.0|||||TWO_SIDED|95.0|-19.9|-1.2|||||ATV 300/RTV - LPV/RTV|observed values, HDL cholesterol||-1.2|-19.9|
71153563|NCT00035932|141799478|SUPERIORITY_OR_OTHER||Difference Estimate|-4.1|||||TWO_SIDED|95.0|-14.0|7.0|||||ATV 400/SQV - LPV/RTV|Observed values, HDL cholesterol||7.0|-14.0|
71153564|NCT00035932|141799478|SUPERIORITY_OR_OTHER||Difference Estimate|-12.7|||||TWO_SIDED|95.0|-22.3|-1.8|||||ATV 300/RTV - LPV/RTV|observed cases, fasting LDL||-1.8|-22.3|
71153565|NCT00035932|141799478|SUPERIORITY_OR_OTHER||Difference Estimate|-7.9|||||TWO_SIDED|95.0|-19.0|4.8|||||ATV 400/SQV - LPV/RTV|Observed Cases, Fasting LDL cholesterol||4.8|-19.0|
71153566|NCT00035932|141799478|SUPERIORITY_OR_OTHER||Difference Estimate|-24.8|||||TWO_SIDED|95.0|-38.6|-8.0|||||ATV 300/RTV - LPV/RTV|observed cases, fasting triglycerides||-8.0|-38.6|
71153567|NCT00035932|141799478|SUPERIORITY_OR_OTHER||Difference Estimate|-19.8|||||TWO_SIDED|95.0|-36.5|1.3|||||ATV 400/SQV - LPV/RTV|observed cases, fasting triglycerides||1.3|-36.5|
71153568|NCT00035932|141799489|SUPERIORITY_OR_OTHER||time-averaged difference|0.14|||||TWO_SIDED|97.5|-0.13|0.41|||||ATV 300/RTV - LPV/RTV|overall||0.41|-0.13|
71153569|NCT00035932|141799489|SUPERIORITY_OR_OTHER||time-averaged difference|0.11|||||TWO_SIDED|97.5|-0.16|0.38|||||ATV 300/RTV - LPV/RTV|last observation carried forward||0.38|-0.16|
71153570|NCT00356304|141799522|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANCOVA|||||||<.05
71153571|NCT02260180|141799536|SUPERIORITY|2-tail alpha was set to 0.05 with no adjustment for multiple comparisons.|||||<|0.0001|||||||Chi-squared|||||||<0.0001
71153572|NCT02260180|141799536|SUPERIORITY||||||<|0.0001|||||||Chi-squared|2-tail alpha was set to 0.05 with no adjustment for multiple comparisons.||||||<0.0001
71153573|NCT02260180|141799537|SUPERIORITY||||||<|0.0001||||||No adjustment for multiple comparisons were made.|ANCOVA|Baseline PLA was the covariate. Comparisons were performed within the model using least-squares means and the common error term.||||||<0.0001
71153574|NCT02260180|141799537|OTHER||||||<|0.0001||||||No adjustment for multiple comparisons were conducted.|ANCOVA|Baseline PLA was the covariate. Comparisons were performed within the model using least-squares means and the common error term.||The primary efficacy analysis of mean change from baseline to Visit 8 PLA was performed using analysis of covariance (ANCOVA) with baseline PLA as the covariate. Comparisons between vehicle and each A-101 group were performed within the model using least-squares means and the common error term.||||<0.0001
71153575|NCT03860818|141799553|SUPERIORITY||||||<|0.001|||||||Chi-squared|||Rate of inpatient hospitalization during study||||<.001
71153576|NCT03860818|141799553|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<.0001
71153577|NCT03860818|141799554|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Statistical analysis applies to all rows.||||||<0.001
71153578|NCT03860818|141799555|SUPERIORITY|||||||0.9064|||||||Chi-squared|||||||0.9064
71153579|NCT03860818|141799556|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.51
71153580|NCT05367492|141799564|SUPERIORITY||Odds Ratio (OR)|6.5|||<|0.001|TWO_SIDED|95.0|3.0|14.1|||Regression, Logistic|Model fit to data from varenicline and placebo groups only, adjusted for sex and baseline E-cigarette Dependence Inventory score.|Adjusted odds ratio comparing varenicline (numerator) versus placebo (denominator).|||14.1|3.0|<0.001
71153581|NCT05367492|141799564|SUPERIORITY||||||<|0.001||||||The p-value is adjusted for multiple comparisons using per Benjamini \& Hochberg (1995) across the primary outcome measure. Effects were deemed significant for p\<0.05.|Regression, Logistic|Omnibus tests for any difference in abstinence rates across study groups, based on χ² Wald statistic and adjusted for sex and baseline ECDI score.||||||<0.001
71153582|NCT05367492|141799565|SUPERIORITY||Odds Ratio (OR)|6.1|||<|0.001|TWO_SIDED|95.0|3.1|12.3||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of five secondary analysis results (Varenicline vs Placebo comparisons of secondary abstinence outcomes, and omnibus tests of all three abstinence outcomes).|Regression, Logistic|Model fit to data from varenicline and placebo groups only, adjusted for sex and baseline E-cigarette Dependence Inventory score.|Adjusted odds ratio comparing varenicline (numerator) versus placebo (denominator).|||12.3|3.1|<0.001
71153583|NCT05367492|141799565|SUPERIORITY||||||<|0.001||||||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of five secondary analysis results (Varenicline vs Placebo comparisons of secondary abstinence outcomes, and omnibus tests of all three abstinence outcomes).|Regression, Logistic|Omnibus tests for any difference in abstinence rates across study groups, based on χ² Wald statistic and adjusted for sex and baseline ECDI score.||||||<0.001
70907315|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.165||0.0531|TWO_SIDED|95.0|-0.65|0.0|||MMRM|||Somatic Symptoms GI, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.65|0.0531
71153584|NCT05367492|141799566|SUPERIORITY||Odds Ratio (OR)|6.0||||0.001|TWO_SIDED|95.0|2.1|16.9||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of five secondary analysis results (Varenicline vs Placebo comparisons of secondary abstinence outcomes, and omnibus tests of all three abstinence outcomes).|Regression, Logistic|Model fit to data from varenicline and placebo groups only, adjusted for sex and baseline E-cigarette Dependence Inventory score.|Adjusted odds ratio comparing varenicline (numerator) versus placebo (denominator).|||16.9|2.1|0.001
71153585|NCT05367492|141799566|SUPERIORITY||||||<|0.001||||||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of five secondary analysis results (Varenicline vs Placebo comparisons of secondary abstinence outcomes, and omnibus tests of all three abstinence outcomes).|Regression, Logistic|Omnibus tests for any difference in abstinence rates across study groups, based on χ² Wald statistic and adjusted for sex and baseline ECDI score.||||||<0.001
71153586|NCT05367492|141799567|SUPERIORITY||Mean Difference (Net)|-1.88||||0.001|TWO_SIDED|95.0|-2.93|-0.83||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of three secondary analysis results (Varenicline vs Placebo comparisons of secondary inventory outcomes).|Regression, Linear|Models fit to data from varenicline and placebo groups only using GEE, adjusted for sex, baseline ECDI and outcome score, and quadratic trend of time.|Adjusted mean difference comparing varenicline versus placebo. Negative indicates larger mean in placebo.|||-0.83|-2.93|0.001
71153587|NCT05367492|141799567|SUPERIORITY||||||<|0.001||||||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of three secondary analysis results (Varenicline vs Placebo comparisons of secondary inventory outcomes).|Regression, Linear|Models fit using GEE, adjusted for sex, baseline ECDI and outcome score, and quadratic time. Omnibus Wald test of any difference across study group.||||||<0.001
71153588|NCT05367492|141799568|SUPERIORITY||Mean Difference (Net)|-6.76|||<|0.001|TWO_SIDED|95.0|-9.08|-4.45||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of three secondary analysis results (Varenicline vs Placebo comparisons of secondary inventory outcomes).|Regression, Linear|Models fit to data from varenicline and placebo groups only using GEE, adjusted for sex, baseline ECDI and outcome score, and quadratic trend of time.|Adjusted mean difference comparing varenicline versus placebo. Negative indicates larger mean in placebo.|||-4.45|-9.08|<0.001
71153589|NCT05367492|141799568|SUPERIORITY||||||<|0.001||||||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of three secondary analysis results (Omnibus tests of secondary inventory outcomes).|Regression, Linear|Models fit using GEE, adjusted for sex, baseline ECDI and outcome score, and quadratic time. Omnibus Wald test of any difference across study groups.||||||<0.001
71153590|NCT05367492|141799569|SUPERIORITY||Mean Difference (Net)|-1.78||||0.008|TWO_SIDED|95.0|-3.08|-0.48||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of three secondary analysis results (Varenicline vs Placebo comparisons of secondary inventory outcomes).|Regression, Linear|Models fit to data from varenicline and placebo groups only using GEE, adjusted for sex, baseline ECDI and outcome score, and quadratic trend of time.|Adjusted mean difference comparing varenicline versus placebo. Negative indicates larger mean in placebo.|||-0.48|-3.08|0.008
70907316|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.16||0.5609|TWO_SIDED|95.0|-0.41|0.22|||MMRM|||Somatic Symptoms GI, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.41|0.5609
70907317|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.123||0.6779|TWO_SIDED|95.0|-0.3|0.19|||MMRM|||Somatic Symptoms General, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.30|0.6779
70907318|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.119||0.4559|TWO_SIDED|95.0|-0.15|0.32|||MMRM|||Somatic Symptoms General, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.15|0.4559
70969793|NCT00708500|141445163|SUPERIORITY_OR_OTHER||Treatment Difference|45.2|||<|0.0001||95.0|33.7|56.8|||Cochran-Mantel-Haenszel||Difference in percentage of participants who achieved SVR: experimental minus control.|||56.8|33.7|<0.0001
71091969|NCT01126424|141690519|SUPERIORITY_OR_OTHER||Least Square Mean Difference|1.846||||0.6753|TWO_SIDED|95.0|-7.02|10.713|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||10.713|-7.020|0.6753
71153591|NCT05367492|141799569|SUPERIORITY|||||||0.02||||||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of three secondary analysis results (Omnibus Wald test of secondary inventory outcomes).|Regression, Linear|Models fit using GEE, adjusted for sex, baseline ECDI and outcome score, and quadratic time. Omnibus Wald test of any difference across study groups.||||||0.02
71153592|NCT05367492|141799570|SUPERIORITY|||||||0.16|||||||Fisher Exact|||||||0.16
71153593|NCT05367492|141799570|SUPERIORITY|||||||0.083|||||||Fisher Exact|||||||0.083
70907319|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.133||0.2254|TWO_SIDED|95.0|-0.43|0.1|||MMRM|||Somatic Symptoms General, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.43|0.2254
70907320|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.129||0.6437|TWO_SIDED|95.0|-0.32|0.2|||MMRM|||Somatic Symptoms General, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.32|0.6437
70907321|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.133||0.6678|TWO_SIDED|95.0|-0.32|0.21|||MMRM|||Somatic Symptoms General, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.32|0.6678
70907322|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.129||0.9321|TWO_SIDED|95.0|-0.27|0.24|||MMRM|||Somatic Symptoms General, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.27|0.9321
70907323|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.157||0.9778|TWO_SIDED|95.0|-0.31|0.32|||MMRM|||Somatic Symptoms General, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.31|0.9778
70907324|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.152||0.9307|TWO_SIDED|95.0|-0.29|0.31|||MMRM|||Somatic Symptoms General, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.29|0.9307
70907325|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.172||0.6791|TWO_SIDED|95.0|-0.41|0.27|||MMRM|||Somatic Symptoms General, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.41|0.6791
70907326|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.167||0.7769|TWO_SIDED|95.0|-0.28|0.38|||MMRM|||Somatic Symptoms General, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.38|-0.28|0.7769
70907327|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.163||0.7206|TWO_SIDED|95.0|-0.38|0.26|||MMRM|||Somatic Symptoms General, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.38|0.7206
70907328|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.156||0.3549|TWO_SIDED|95.0|-0.45|0.16|||MMRM|||Somatic Symptoms General, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.45|0.3549
70907329|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.164||0.0231|TWO_SIDED|95.0|-0.7|-0.05|||MMRM|||Somatic Symptoms General, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.05|-0.70|0.0231
70907330|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.159||0.145|TWO_SIDED|95.0|-0.55|0.08|||MMRM|||Somatic Symptoms General, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.55|0.1450
70907331|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.162||0.0855|TWO_SIDED|95.0|-0.6|0.04|||MMRM|||Somatic Symptoms General, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.60|0.0855
70907332|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.157||0.3068|TWO_SIDED|95.0|-0.47|0.15|||MMRM|||Somatic Symptoms General, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.47|0.3068
70907333|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.164||0.0069|TWO_SIDED|95.0|-0.77|-0.13|||MMRM|||Somatic Symptoms General, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.13|-0.77|0.0069
70907334|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.159||0.2174|TWO_SIDED|95.0|-0.51|0.12|||MMRM|||Somatic Symptoms General, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.51|0.2174
70907335|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.174||0.102|TWO_SIDED|95.0|-0.63|0.06|||MMRM|||Somatic Symptoms General, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.63|0.1020
70907336|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.17||0.9587|TWO_SIDED|95.0|-0.33|0.35|||MMRM|||Somatic Symptoms General, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.33|0.9587
70907337|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.203||0.169|TWO_SIDED|95.0|-0.69|0.12|||MMRM|||Somatic Symptoms General, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.69|0.1690
70907338|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.197||0.7919|TWO_SIDED|95.0|-0.34|0.44|||MMRM|||Somatic Symptoms General, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.44|-0.34|0.7919
70907339|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.205||0.0192|TWO_SIDED|95.0|-0.89|-0.08|||MMRM|||Somatic Symptoms General, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.08|-0.89|0.0192
70907340|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.196||0.3887|TWO_SIDED|95.0|-0.56|0.22|||MMRM|||Somatic Symptoms General, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.56|0.3887
70907341|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.189||0.0719|TWO_SIDED|95.0|-0.72|0.03|||MMRM|||Somatic Symptoms General, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.72|0.0719
70907342|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.185||0.1195|TWO_SIDED|95.0|-0.66|0.08|||MMRM|||Somatic Symptoms General, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.66|0.1195
70969794|NCT00708500|141445164|SUPERIORITY_OR_OTHER||Treatment Difference|39.1|||<|0.0001||95.0|27.2|51.0|||Cochran-Mantel-Haenszel||Difference in percentage of participants who achieved SVR: experimental minus control.|||51.0|27.2|<0.0001
70907343|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.079||0.9552|TWO_SIDED|95.0|-0.16|0.15|||MMRM|||Genital Symptoms, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.16|0.9552
70907344|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.076||0.0384|TWO_SIDED|95.0|-0.31|-0.01|||MMRM|||Genital Symptoms, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.31|0.0384
70907345|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.097||0.2582|TWO_SIDED|95.0|-0.3|0.08|||MMRM|||Genital Symptoms, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.30|0.2582
70907346|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.094||0.1511|TWO_SIDED|95.0|-0.32|0.05|||MMRM|||Genital Symptoms, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.32|0.1511
70907347|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.126||0.4631|TWO_SIDED|95.0|-0.34|0.16|||MMRM|||Genital Symptoms, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.34|0.4631
70907348|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.123||0.4628|TWO_SIDED|95.0|-0.33|0.15|||MMRM|||Genital Symptoms, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.33|0.4628
70907349|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.11||0.9005|TWO_SIDED|95.0|-0.23|0.2|||MMRM|||Genital Symptoms, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.23|0.9005
70907350|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.107||0.1121|TWO_SIDED|95.0|-0.38|0.04|||MMRM|||Genital Symptoms, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.38|0.1121
70907351|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.145||0.4167|TWO_SIDED|95.0|-0.4|0.17|||MMRM|||Genital Symptoms, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.40|0.4167
70907352|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.141||0.4071|TWO_SIDED|95.0|-0.4|0.16|||MMRM|||Genital Symptoms, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.40|0.4071
70907353|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.15||0.1278|TWO_SIDED|95.0|-0.53|0.07|||MMRM|||Genital Symptoms, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.53|0.1278
70907354|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.145||0.0573|TWO_SIDED|95.0|-0.57|0.01|||MMRM|||Genital Symptoms, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.57|0.0573
70969795|NCT00708500|141445164|SUPERIORITY_OR_OTHER||Treatment Difference|45.1|||<|0.0001||95.0|33.4|56.8|||Cochran-Mantel-Haenszel||Difference in percentage of participants who achieved SVR: experimental minus control.|||56.8|33.4|<0.0001
70969796|NCT00595556|141445177|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Mixed Models Analysis|||||||.012
70969797|NCT00595556|141445178|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||Mixed Models Analysis|||||||.94
70907355|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.156||0.4842|TWO_SIDED|95.0|-0.42|0.2|||MMRM|||Genital Symptoms, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.42|0.4842
70907356|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.152||0.0692|TWO_SIDED|95.0|-0.58|0.02|||MMRM|||Genital Symptoms, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.58|0.0692
70907357|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.157||0.4028|TWO_SIDED|95.0|-0.44|0.18|||MMRM|||Genital Symptoms, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.44|0.4028
70907358|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.154||0.0354|TWO_SIDED|95.0|-0.63|-0.02|||MMRM|||Genital Symptoms, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-0.63|0.0354
70907359|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.156||0.1228|TWO_SIDED|95.0|-0.55|0.07|||MMRM|||Genital Symptoms, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.55|0.1228
70907360|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.152||0.0099|TWO_SIDED|95.0|-0.7|-0.1|||MMRM|||Genital Symptoms, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.10|-0.70|0.0099
70907361|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.164||0.2174|TWO_SIDED|95.0|-0.53|0.12|||MMRM|||Genital Symptoms, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.53|0.2174
70907362|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.161||0.082|TWO_SIDED|95.0|-0.6|0.04|||MMRM|||Genital Symptoms, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.60|0.0820
70907363|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.194||0.2642|TWO_SIDED|95.0|-0.6|0.17|||MMRM|||Genital Symptoms, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.60|0.2642
70907364|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.189||0.0718|TWO_SIDED|95.0|-0.72|0.03|||MMRM|||Genital Symptoms, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.72|0.0718
70907365|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.212||0.3055|TWO_SIDED|95.0|-0.64|0.2|||MMRM|||Genital Symptoms, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.64|0.3055
70907366|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.202||0.3533|TWO_SIDED|95.0|-0.59|0.21|||MMRM|||Genital Symptoms, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.59|0.3533
70969798|NCT00595556|141445179|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Mixed Models Analysis|||||||.004
70969799|NCT00595556|141445180|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Mixed Models Analysis|||||||.006
70969800|NCT00595556|141445181|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Mixed Models Analysis|||||||.3
70907367|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.193||0.4514|TWO_SIDED|95.0|-0.53|0.24|||MMRM|||Genital Symptoms, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.53|0.4514
70907368|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.191||0.4907|TWO_SIDED|95.0|-0.51|0.25|||MMRM|||Genital Symptoms, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.51|0.4907
70907369|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.151||0.6949|TWO_SIDED|95.0|-0.36|0.24|||MMRM|||Hypochondriasis, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.36|0.6949
70907370|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.147||0.467|TWO_SIDED|95.0|-0.4|0.18|||MMRM|||Hypochondriasis, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.40|0.4670
70907371|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.16||0.6556|TWO_SIDED|95.0|-0.39|0.25|||MMRM|||Hypochondriasis, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.39|0.6556
70907372|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.156||0.9272|TWO_SIDED|95.0|-0.32|0.29|||MMRM|||Hypochondriasis, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.32|0.9272
70907373|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.164||0.1395|TWO_SIDED|95.0|-0.57|0.08|||MMRM|||Hypochondriasis, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.57|0.1395
70907374|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.159||0.2601|TWO_SIDED|95.0|-0.5|0.14|||MMRM|||Hypochondriasis, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.50|0.2601
70907375|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.158||0.5626|TWO_SIDED|95.0|-0.4|0.22|||MMRM|||Hypochondriasis, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.40|0.5626
70907376|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.153||0.4622|TWO_SIDED|95.0|-0.42|0.19|||MMRM|||Hypochondriasis, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.42|0.4622
70907377|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.151||0.2858|TWO_SIDED|95.0|-0.46|0.14|||MMRM|||Hypochondriasis, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.46|0.2858
70907378|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.146||0.5369|TWO_SIDED|95.0|-0.38|0.2|||MMRM|||Hypochondriasis, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.38|0.5369
71091970|NCT01126424|141690520|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.507||||0.5684|TWO_SIDED|95.0|-2.293|1.279|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||1.279|-2.293|0.5684
70907379|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.15||0.151|TWO_SIDED|95.0|-0.52|0.08|||MMRM|||Hypochondriasis, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.52|0.1510
70907380|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.146||0.5107|TWO_SIDED|95.0|-0.38|0.19|||MMRM|||Hypochondriasis, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.38|0.5107
70907381|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.151||0.3301|TWO_SIDED|95.0|-0.45|0.15|||MMRM|||Hypochondriasis, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.45|0.3301
70907382|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.147||0.5139|TWO_SIDED|95.0|-0.39|0.19|||MMRM|||Hypochondriasis, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.39|0.5139
70907383|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.144||0.4073|TWO_SIDED|95.0|-0.4|0.17|||MMRM|||Hypochondriasis, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.40|0.4073
70907384|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.4649|TWO_SIDED|95.0|-0.38|0.17|||MMRM|||Hypochondriasis, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.38|0.4649
70907385|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.141||0.6926|TWO_SIDED|95.0|-0.34|0.22|||MMRM|||Hypochondriasis, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.34|0.6926
70907386|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.137||0.726|TWO_SIDED|95.0|-0.22|0.32|||MMRM|||Hypochondriasis, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.22|0.7260
70907387|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.136||0.1486|TWO_SIDED|95.0|-0.47|0.07|||MMRM|||Hypochondriasis, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.47|0.1486
70907388|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.133||0.48|TWO_SIDED|95.0|-0.36|0.17|||MMRM|||Hypochondriasis, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.36|0.4800
70907389|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.177||0.7792|TWO_SIDED|95.0|-0.4|0.3|||MMRM|||Hypochondriasis, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.40|0.7792
70907390|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.171||0.8644|TWO_SIDED|95.0|-0.31|0.37|||MMRM|||Hypochondriasis, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.31|0.8644
71091971|NCT01126424|141690520|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.792||||0.2348|TWO_SIDED|95.0|-2.122|0.538|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||0.538|-2.122|0.2348
70969801|NCT00705783|141445182|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.199|||<|0.0001|TWO_SIDED|95.0|0.125|0.317|||Log Rank||Aripiprazole depot/placebo depot|Based on 6-month IR rates of 55% for placebo and 35% for aripiprazole, sample sizes were estimated to achieve 90% power to detect a hazard ratio of 0.54 and to preserve an overall nominal alpha level of 0.05 (2-sided), allowing for 2 interim looks at 50% and 75% of events. Assuming that each subject was followed for 12 months after randomization and allowing for a 25% loss to follow-up, the projected total number of subjects to be randomly assigned to treatment in the trial was 225.||0.317|0.125|<0.0001
70969802|NCT00705783|141445183|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The alpha levels for this key secondary Outcome Measure were the same as used for the primary Outcome Measure.|Chi-squared|||||||<0.0001
70969803|NCT00705783|141445184|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
70969804|NCT00705783|141445185|SUPERIORITY_OR_OTHER|||||||0.1756||95.0|||||Chi-squared|||||||0.1756
70969805|NCT00705783|141445186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.11|||<|0.0001|TWO_SIDED|95.0|-12.68|-7.54|||ANCOVA|The ANCOVA included treatment as a term and baseline as a covariate.||||-7.54|-12.68|<0.0001
70969806|NCT00705783|141445187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.35|||ANCOVA|The ANCOVA included treatment as a term and baseline as a covariate.||||-0.35|-0.70|<0.0001
70969807|NCT00705783|141445188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.82|||<|0.0001|TWO_SIDED|95.0|-4.72|-2.91|||ANCOVA|The ANCOVA included treatment as a term and baseline as a covariate.||Positive Subscale Score||-2.91|-4.72|<0.0001
70969808|NCT00705783|141445189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36||||0.0001|TWO_SIDED|95.0|-2.04|-0.67|||ANCOVA|The ANCOVA included treatment as a term and baseline as a covariate.||||-0.67|-2.04|0.0001
70969809|NCT00705783|141445190|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
70907391|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.158||0.7994|TWO_SIDED|95.0|-0.27|0.35|||MMRM|||Hypochondriasis, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.27|0.7994
70969810|NCT00705783|141445191|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||||||<0.0001
70969811|NCT02997735|141445197|SUPERIORITY||Odds Ratio (OR)|7.78|||<|0.001|TWO_SIDED|95.0|2.81|27.9|||Chi-squared||ORs from multivariable logistic regression model of characteristics associated with successful quitline enrollment.|||27.90|2.81|<0.001
70969812|NCT02997735|141445198|SUPERIORITY||Odds Ratio (OR)|0.48||||0.15|TWO_SIDED|95.0|0.13|1.72|||Chi-squared||1-5 years Row (\<1 Ref)|||1.72|0.13|0.15
70969813|NCT02997735|141445198|SUPERIORITY||Odds Ratio (OR)|0.61|||||TWO_SIDED|95.0|0.18|2.12|||||6-12 years Row (\<1 Ref)|||2.12|0.18|
70969814|NCT02997735|141445198|SUPERIORITY||Odds Ratio (OR)|1.82|||||TWO_SIDED|95.0|0.49|6.94|||||13 or Older Row (\<1 Ref)|||6.94|0.49|
70969815|NCT02997735|141445199|SUPERIORITY||Odds Ratio (OR)|2.38||||0.028|TWO_SIDED|95.0|0.92|6.5|||Chi-squared||35-49 years Row (18-34 Ref)|||6.50|0.92|0.028
70969816|NCT02997735|141445199|SUPERIORITY||Odds Ratio (OR)|5.1|||||TWO_SIDED|95.0|1.46|17.32|||||50 or older Row (18-34 Ref)|||17.32|1.46|
70969817|NCT02997735|141445200|SUPERIORITY||Odds Ratio (OR)|1.1||||0.85|TWO_SIDED|95.0|0.4|2.8|||Chi-squared||Asthma Row (No asthma Ref)|||2.80|0.40|0.85
70969818|NCT02997735|141445201|SUPERIORITY||Odds Ratio (OR)|2.07||||0.086|TWO_SIDED|95.0|0.9|6.5|||Chi-squared||10 or more cigarettes Row (\<10 cigarettes Ref)|||6.50|0.90|0.086
70969819|NCT02997735|141445202|SUPERIORITY||Odds Ratio (OR)|0.47||||0.35|TWO_SIDED|95.0|0.15|1.27|||Chi-squared||Less than 6 months Row (30 days Ref)|||1.27|0.15|0.35
70969820|NCT02997735|141445202|SUPERIORITY||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.15|2.21|||||||6 or more months Row (30 days Ref)|2.21|0.15|
70969821|NCT03029143|141445203|OTHER||Odds Ratio (OR)|0.6|||=|0.401|TWO_SIDED|95.0|0.2|1.8|||Chi-squared||||Chi-squared test was used to estimate P-value from the logistic regression model where Endoscopic Mucosal Healing was the response variable and Treatment and TNF stratification were factors. Baseline complete Mayo Score and natural logarithm of trough concentration at week 6 were covariates.|1.8|0.2|=0.401
70969822|NCT03029143|141445204|OTHER||Adjusted risk difference|-0.4|||=|0.943|TWO_SIDED|95.0|-11.4|10.6|||CMH Chi-square test||||Cochran-Mantel-Haenszel (CMH) chi-square test was stratified by TNF antagonist status.|10.6|-11.4|=0.943
70969823|NCT03029143|141445205|OTHER||Adjusted risk difference|-1.2|||=|0.893|TWO_SIDED|95.0|-18.7|16.3|||CMH Chi-square test||||Cochran-Mantel-Haenszel (CMH) chi-square test was stratified by TNF antagonist status.|16.3|-18.7|=0.893
70969824|NCT03029143|141445206|OTHER||Adjusted risk difference|6.0|||=|0.525|TWO_SIDED|95.0|-12.4|24.3|||CMH Chi-square test||||Cochran-Mantel-Haenszel (CMH) chi-square test was stratified by TNF antagonist status.|24.3|-12.4|=0.525
70969825|NCT03029143|141445207|OTHER||Adjusted risk difference|-6.6|||=|0.623|TWO_SIDED|95.0|-34.0|20.8|||CMH Chi-square test||||Cochran-Mantel-Haenszel (CMH) chi-square test was stratified by TNF antagonist status.|20.8|-34.0|=0.623
70969826|NCT03029143|141445208|SUPERIORITY||Adjusted risk difference|8.1|||=|0.344|TWO_SIDED|95.0|-8.5|24.7|||CMH Chi-square test||||Cochran-Mantel-Haenszel (CMH) chi-square test was stratified by TNF antagonist status.|24.7|-8.5|=0.344
70969827|NCT00619255|141445222|SUPERIORITY||Slope|1.38||||0.71|TWO_SIDED||||||Chi-squared|DF=3||||||0.71
70969828|NCT00619255|141445223|SUPERIORITY||Slope|1.02||||0.8|TWO_SIDED||||||Chi-squared|DF=3||||||0.80
70969829|NCT00619255|141445224|SUPERIORITY|||||||0.67|||||||Chi-squared|"DF = 1~Chi-Square Value = 0.18"||||||0.67
70969830|NCT00619255|141445225|SUPERIORITY||Slope|9.0||||0.03|TWO_SIDED||||||Chi-squared|DF=3||||||0.03
70969831|NCT00619255|141445226|SUPERIORITY||Slope|1.35||||0.72|TWO_SIDED||||||Chi-squared|DF=3||||||0.72
70969832|NCT02121262|141445227|SUPERIORITY||Rate Difference|1.5||||0.7431|TWO_SIDED|95.0|-5.9|8.9|||Cochran-Mantel-Haenszel|Based on the Cochran-Mantel-Haenszel (CMH) general association test stratified by baseline BCVA categories.||||8.9|-5.9|0.7431
70907392|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.27|STANDARD_ERROR_OF_MEAN|0.152||0.0811|TWO_SIDED|95.0|-0.03|0.57|||MMRM|||Hypochondriasis, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.57|-0.03|0.0811
70907393|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.144||0.6978|TWO_SIDED|95.0|-0.34|0.23|||MMRM|||Hypochondriasis, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.34|0.6978
70907394|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.141||0.9749|TWO_SIDED|95.0|-0.28|0.28|||MMRM|||Hypochondriasis, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.28|0.9749
70907395|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.081||0.3158|TWO_SIDED|95.0|-0.08|0.24|||MMRM|||Loss of Weight, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.08|0.3158
70907396|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.079||0.1901|TWO_SIDED|95.0|-0.05|0.26|||MMRM|||Loss of Weight, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.05|0.1901
70907397|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.073||0.7229|TWO_SIDED|95.0|-0.12|0.17|||MMRM|||Loss of Weight, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.12|0.7229
70907398|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.071||0.2715|TWO_SIDED|95.0|-0.06|0.22|||MMRM|||Loss of Weight, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.06|0.2715
70907399|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.086||0.5421|TWO_SIDED|95.0|-0.12|0.22|||MMRM|||Loss of Weight, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.12|0.5421
70907400|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.083||0.7215|TWO_SIDED|95.0|-0.14|0.19|||MMRM|||Loss of Weight, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.14|0.7215
70907401|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.098||0.2246|TWO_SIDED|95.0|-0.07|0.31|||MMRM|||Loss of Weight, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.07|0.2246
70907402|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.096||0.9671|TWO_SIDED|95.0|-0.19|0.19|||MMRM|||Loss of Weight, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.19|0.9671
70907403|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.121||0.6527|TWO_SIDED|95.0|-0.29|0.19|||MMRM|||Loss of Weight, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.29|0.6527
71091972|NCT01126424|141690521|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.04||||0.6275|TWO_SIDED|95.0|-0.208|0.127|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||0.127|-0.208|0.6275
70907404|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.118||0.1647|TWO_SIDED|95.0|-0.4|0.07|||MMRM|||Loss of Weight, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.40|0.1647
70907405|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.11||0.7093|TWO_SIDED|95.0|-0.18|0.26|||MMRM|||Loss of Weight, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.18|0.7093
70907406|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.107||0.6333|TWO_SIDED|95.0|-0.26|0.16|||MMRM|||Loss of Weight, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.26|0.6333
70907407|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.12||0.5238|TWO_SIDED|95.0|-0.31|0.16|||MMRM|||Loss of Weight, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.31|0.5238
70907408|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.117||0.0782|TWO_SIDED|95.0|-0.44|0.02|||MMRM|||Loss of Weight, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.44|0.0782
70907409|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.138||0.2346|TWO_SIDED|95.0|-0.44|0.11|||MMRM|||Loss of Weight, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.44|0.2346
70907410|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.134||0.0631|TWO_SIDED|95.0|-0.52|0.01|||MMRM|||Loss of Weight, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.52|0.0631
70907411|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.131||0.6274|TWO_SIDED|95.0|-0.32|0.2|||MMRM|||Loss of Weight, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.32|0.6274
70907412|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.128||0.3589|TWO_SIDED|95.0|-0.37|0.14|||MMRM|||Loss of Weight, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.37|0.3589
70907413|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.187||0.7604|TWO_SIDED|95.0|-0.43|0.31|||MMRM|||Loss of Weight, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.43|0.7604
70907414|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.185||0.1106|TWO_SIDED|95.0|-0.66|0.07|||MMRM|||Loss of Weight, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.66|0.1106
70907415|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.222||0.9776|TWO_SIDED|95.0|-0.43|0.45|||MMRM|||Loss of Weight, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.45|-0.43|0.9776
71091973|NCT01126424|141690521|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.046||||0.5361|TWO_SIDED|95.0|-0.194|0.103|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||0.103|-0.194|0.5361
70907416|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.217||0.3239|TWO_SIDED|95.0|-0.65|0.22|||MMRM|||Loss of Weight, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.65|0.3239
70907417|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.238||0.6736|TWO_SIDED|95.0|-0.57|0.37|||MMRM|||Loss of Weight, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.57|0.6736
70907418|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.231||0.6136|TWO_SIDED|95.0|-0.58|0.34|||MMRM|||Loss of Weight, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.34|-0.58|0.6136
70907419|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.195||0.1141|TWO_SIDED|95.0|-0.7|0.08|||MMRM|||Loss of Weight, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.70|0.1141
70907420|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.194||0.2185|TWO_SIDED|95.0|-0.62|0.14|||MMRM|||Loss of Weight, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.62|0.2185
70907421|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.054||0.6191|TWO_SIDED|95.0|-0.08|0.13|||MMRM|||Insight, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.08|0.6191
70907422|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.053||0.6169|TWO_SIDED|95.0|-0.08|0.13|||MMRM|||Insight, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.08|0.6169
70907423|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.054||0.9911|TWO_SIDED|95.0|-0.11|0.11|||MMRM|||Insight, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.11|0.9911
70907424|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.053||0.336|TWO_SIDED|95.0|-0.05|0.15|||MMRM|||Insight, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.05|0.3360
70907425|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.054||0.9638|TWO_SIDED|95.0|-0.11|0.1|||MMRM|||Insight, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.11|0.9638
70969833|NCT02121262|141445228|SUPERIORITY||Least Squares Mean (LSM) Difference|2.9|STANDARD_ERROR_OF_MEAN|0.89||0.0011|TWO_SIDED|95.0|1.17|4.66|||ANCOVA|The ANCOVA model included the treatment group as the main effect and baseline BCVA score as the covariate.|Null hypothesis-there was no difference in treatment groups of average BCVA CFB in 12-months. Hypothesis test-based on 2-sided test at 0.05 significance level,confidence interval(CI) was constructed between treatment groups in LSM using ANCOVA model.|||4.66|1.17|0.0011
70907426|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.053||0.161|TWO_SIDED|95.0|-0.03|0.18|||MMRM|||Insight, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.03|0.1610
70907427|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.054||0.5763|TWO_SIDED|95.0|-0.14|0.08|||MMRM|||Insight, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.14|0.5763
70907428|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.053||0.0599|TWO_SIDED|95.0|0.0|0.2|||MMRM|||Insight, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|0.00|0.0599
70907429|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.054||0.3916|TWO_SIDED|95.0|-0.15|0.06|||MMRM|||Insight, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.15|0.3916
70907430|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.053||0.9602|TWO_SIDED|95.0|-0.1|0.11|||MMRM|||Insight, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.10|0.9602
70907431|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.055||0.9676|TWO_SIDED|95.0|-0.11|0.11|||MMRM|||Insight, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.11|0.9676
70907432|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.053||0.6397|TWO_SIDED|95.0|-0.08|0.13|||MMRM|||Insight, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.08|0.6397
70907433|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.054||0.34|TWO_SIDED|95.0|-0.05|0.16|||MMRM|||Insight, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.05|0.3400
70907434|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.053||0.3472|TWO_SIDED|95.0|-0.05|0.15|||MMRM|||Insight, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.05|0.3472
70907435|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.054||0.916|TWO_SIDED|95.0|-0.11|0.1|||MMRM|||Insight, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.11|0.9160
70907436|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.053||0.5948|TWO_SIDED|95.0|-0.13|0.08|||MMRM|||Insight, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.13|0.5948
70907437|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.054||0.3755|TWO_SIDED|95.0|-0.06|0.16|||MMRM|||Insight, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.06|0.3755
70969834|NCT02121262|141445229|SUPERIORITY||Least Squares Mean Difference|-89.3|STANDARD_ERROR_OF_MEAN|16.89|<|0.0001|TWO_SIDED|95.0|-122.53|-56.01|||ANCOVA|Based on ANCOVA model with treatment and baseline BCVA categories as main effects and baseline retinal thickness as the covariate.|Null hypothesis was there was no difference in treatment groups in average BCVA CFB in 12-months. Hypothesis test was based on 2-sided test at 0.05 significance level. 2-sided 95% CI was constructed between treatment groups in LSM using ANCOVA model.|||-56.01|-122.53|<0.0001
70907438|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.053||0.9752|TWO_SIDED|95.0|-0.11|0.1|||MMRM|||Insight, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.11|0.9752
70907439|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.054||0.9188|TWO_SIDED|95.0|-0.11|0.1|||MMRM|||Insight, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.11|0.9188
70907440|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.053||0.6379|TWO_SIDED|95.0|-0.08|0.13|||MMRM|||Insight, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.08|0.6379
70907441|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.061||0.4967|TWO_SIDED|95.0|-0.16|0.08|||MMRM|||Insight, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.16|0.4967
70907442|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.059||0.3492|TWO_SIDED|95.0|-0.17|0.06|||MMRM|||Insight, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.17|0.3492
70907443|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.062||0.7136|TWO_SIDED|95.0|-0.1|0.14|||MMRM|||Insight, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.10|0.7136
70907444|NCT02942004|141303703|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.059||0.8163|TWO_SIDED|95.0|-0.1|0.13|||MMRM|||Insight, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.10|0.8163
70907445|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.055||0.2825|TWO_SIDED|95.0|-0.17|0.05|||MMRM|||Insight, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.17|0.2825
70907446|NCT02942004|141303703|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.054||0.1603|TWO_SIDED|95.0|-0.18|0.03|||MMRM|||Insight, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.18|0.1603
70907447|NCT02942004|141303704|SUPERIORITY||LS mean difference|-6.85|STANDARD_ERROR_OF_MEAN|2.414||0.0054|TWO_SIDED|95.0|-11.64|-2.07|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||-2.07|-11.64|0.0054
70907448|NCT02942004|141303704|SUPERIORITY||LS mean difference|-4.2|STANDARD_ERROR_OF_MEAN|2.35||0.0763|TWO_SIDED|95.0|-8.86|0.45|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.45|-8.86|0.0763
70907449|NCT02942004|141303704|SUPERIORITY||LS mean difference|-4.3|STANDARD_ERROR_OF_MEAN|2.673||0.1101|TWO_SIDED|95.0|-9.6|0.99|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.99|-9.60|0.1101
70907450|NCT02942004|141303704|SUPERIORITY||LS mean difference|-1.31|STANDARD_ERROR_OF_MEAN|2.618||0.6167|TWO_SIDED|95.0|-6.5|3.87|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||3.87|-6.50|0.6167
70907451|NCT02942004|141303704|SUPERIORITY||LS mean difference|-5.64|STANDARD_ERROR_OF_MEAN|2.777||0.0447|TWO_SIDED|95.0|-11.14|-0.14|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.14|-11.14|0.0447
71091974|NCT01126424|141690522|SUPERIORITY_OR_OTHER||Least Square Mean Difference|4.655||||0.6315|TWO_SIDED|95.0|-14.858|24.167|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||24.167|-14.858|0.6315
70907452|NCT02942004|141303704|SUPERIORITY||LS mean difference|-3.59|STANDARD_ERROR_OF_MEAN|2.726||0.1908|TWO_SIDED|95.0|-8.99|1.81|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.81|-8.99|0.1908
70907453|NCT02942004|141303705|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0131|TWO_SIDED|95.0|1.3|11.7|||GEE method|||Hour 60: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||11.7|1.3|0.0131
70907454|NCT02942004|141303705|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0095|TWO_SIDED|95.0|1.4|11.6|||GEE method|||Hour 60: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||11.6|1.4|0.0095
70907455|NCT02942004|141303705|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0323|TWO_SIDED|95.0|1.1|7.5|||GEE method|||Day 7: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||7.5|1.1|0.0323
70907456|NCT02942004|141303705|SUPERIORITY||Odds Ratio (OR)|2.2||||0.0931|TWO_SIDED|95.0|0.9|5.3|||GEE method|||Day 7: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||5.3|0.9|0.0931
70907457|NCT02942004|141303705|SUPERIORITY||Odds Ratio (OR)|3.6||||0.0139|TWO_SIDED|95.0|1.3|10.0|||GEE method|||Day 30: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||10.0|1.3|0.0139
70907458|NCT02942004|141303705|SUPERIORITY||Odds Ratio (OR)|2.6||||0.046|TWO_SIDED|95.0|1.0|6.9|||GEE method|||Day 30: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||6.9|1.0|0.0460
70907459|NCT02942004|141303706|SUPERIORITY||LS mean difference|-1.13|STANDARD_ERROR_OF_MEAN|1.454||0.4389|TWO_SIDED|95.0|-4.01|1.75|||MMRM|||Change at Hour 60: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.75|-4.01|0.4389
70907460|NCT02942004|141303706|SUPERIORITY||LS mean difference|-1.05|STANDARD_ERROR_OF_MEAN|1.427||0.4645|TWO_SIDED|95.0|-3.88|1.78|||MMRM|||Change at Hour 60: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.78|-3.88|0.4645
70969835|NCT02121262|141445230|SUPERIORITY||Least Squares Mean Difference|-7.729|STANDARD_ERROR_OF_MEAN|1.0443|<|0.0001|TWO_SIDED|95.0|-9.7855|-5.6733|||ANCOVA|Based on ANCOVA model with treatment and baseline BCVA categories as main effects and baseline total leakage area as the covariate.|Null hypothesis was there was no difference in treatment groups in average BCVA CFB in 12-months. Hypothesis test was based on 2-sided test at 0.05 significance level. 2-sided 95% CI was constructed between treatment groups in LSM using ANCOVA model.|||-5.6733|-9.7855|<0.0001
70907461|NCT02942004|141303706|SUPERIORITY||LS mean difference|-2.56|STANDARD_ERROR_OF_MEAN|1.356||0.0622|TWO_SIDED|95.0|-5.24|0.13|||MMRM|||Change at Day 7: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-5.24|0.0622
70907462|NCT02942004|141303706|SUPERIORITY||LS mean difference|0.25|STANDARD_ERROR_OF_MEAN|1.338||0.8495|TWO_SIDED|95.0|-2.4|2.91|||MMRM|||Change at Day 7: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.91|-2.40|0.8495
70907463|NCT02942004|141303706|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|1.59||0.7063|TWO_SIDED|95.0|-3.75|2.55|||MMRM|||Change at Day 14: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.55|-3.75|0.7063
70907464|NCT02942004|141303706|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|1.552||0.9434|TWO_SIDED|95.0|-3.19|2.97|||MMRM|||Change at Day 14: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.97|-3.19|0.9434
70907465|NCT02942004|141303706|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|1.608||0.9701|TWO_SIDED|95.0|-3.25|3.13|||MMRM|||Change at Day 21: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||3.13|-3.25|0.9701
70907466|NCT02942004|141303706|SUPERIORITY||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|1.566||0.6307|TWO_SIDED|95.0|-3.86|2.35|||MMRM|||Change at Day 21: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.35|-3.86|0.6307
70907467|NCT02942004|141303706|SUPERIORITY||LS mean difference|-2.02|STANDARD_ERROR_OF_MEAN|1.488||0.1767|TWO_SIDED|95.0|-4.97|0.93|||MMRM|||Change at Day 30: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.93|-4.97|0.1767
70907468|NCT02942004|141303706|SUPERIORITY||LS mean difference|-1.46|STANDARD_ERROR_OF_MEAN|1.468||0.3236|TWO_SIDED|95.0|-4.37|1.45|||MMRM|||Change at Day 30: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.45|-4.37|0.3236
70907469|NCT01448044|141303722|SUPERIORITY_OR_OTHER||difference in percentages|38.85|||<|0.0001|TWO_SIDED|95.0|21.703|55.997||The pvalue was based on the CochranMantelHaenszel (CMH) test, stratified by IL28B host genotype, geography, and baseline cirrhosis status.|Cochran-Mantel-Haenszel|||||55.997|21.703|<0.0001
70907470|NCT00507026|141303731|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70907471|NCT00507026|141303731|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70907472|NCT00507026|141303732|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70907473|NCT00507026|141303732|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70907474|NCT00507026|141303733|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70907475|NCT00507026|141303733|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70907476|NCT00507026|141303734|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70907477|NCT00507026|141303734|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70907478|NCT00507026|141303735|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70907479|NCT00507026|141303735|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70907480|NCT03688711|141303757|SUPERIORITY||||||<|0.0001|||||||Log Rank|||The recovery rates of dasiglucagon and placebo were evaluated using a Kaplan Meier (KM) approach, with treatment group as a stratification factor. Differences between the KM curves (dasiglucagon versus placebo) were evaluated inferentially using pairwise two-sided log-rank tests stratified by injection site.||||<0.0001
70907481|NCT03688711|141303758|SUPERIORITY|||||||0.0012|||||||Fisher Exact|||Assessed at 30 minutes. The recovery rates of dasiglucagon and placebo were compared at each time point using a Fisher's exact test. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||0.0012
70907482|NCT03688711|141303758|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Assessed at 20 minutes. The recovery rates of dasiglucagon and placebo were compared at each time point using a Fisher's exact test. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
70907483|NCT03688711|141303758|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Assessed at 15 minutes. The recovery rates of dasiglucagon and placebo were compared at each time point using a Fisher's exact test. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
70907484|NCT03688711|141303758|SUPERIORITY|||||||0.0006|||||||Fisher Exact|||Assessed at 10 minutes. The recovery rates of dasiglucagon and placebo were compared at each time point using a Fisher's exact test. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||0.0006
70907485|NCT03688711|141303759|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Change from baseline in plasma glucose at 30 minutes after investigational product injection was calculated using nominal sampling times and analyzed using an analysis of variance model with treatment, age group and injection site for each endpoint. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
70907486|NCT03688711|141303759|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Change from baseline in plasma glucose at 20 minutes after investigational product injection was calculated using nominal sampling times and analyzed using an analysis of variance model with treatment, age group and injection site for each endpoint. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
70907487|NCT03688711|141303759|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Change from baseline in plasma glucose at 15 minutes after investigational product injection was calculated using nominal sampling times and analyzed using an analysis of variance model with treatment, age group and injection site for each endpoint. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
70907488|NCT03688711|141303759|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Change from baseline in plasma glucose at 10 minutes after investigational product injection was calculated using nominal sampling times and analyzed using an analysis of variance model with treatment, age group and injection site for each endpoint. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
70907489|NCT03688711|141303760|SUPERIORITY||||||<|0.0001|||||||Log Rank|||Evaluated using a Kaplan Meier (KM) approach, with treatment group as a stratification factor, analogous to that used for the primary endpoint analysis. Differences between the KM curves (dasiglucagon versus placebo) were evaluated inferentially using pairwise two-sided log-rank tests. Subjects whose time to first plasma glucose concentration ≥70 mg/dL (3.9 mmol/L) was not met within 45 minutes post-dosing were censored, at the time of the last valid plasma glucose measurement up to 45 minutes.||||<0.0001
70907490|NCT03688711|141303761|SUPERIORITY||Odds Ratio (OR)|4.05|||<|0.0001|TWO_SIDED|95.0|2.71|6.05|||ANCOVA|||The analysis was an analysis of covariance (ANCOVA) model with treatment group as factor and the baseline of the dependent variable plasma glucose as a covariate.||6.05|2.71|<0.0001
70907491|NCT04675242|141303779|SUPERIORITY||Mean Difference (Final Values)|1.9||||0.4434|TWO_SIDED|95.0|-11.5|15.3|||Fisher Exact|||Difference in the proportion of study eyes with complete cure||15.3|-11.5|0.4434
70907492|NCT04675242|141303780|SUPERIORITY||Mean Difference (Final Values)|-3.7||||0.2105|TWO_SIDED|95.0|-9.5|2.1|||ANCOVA|adjusted for baseline eye dryness VAS score||Difference in the change from baseline between treatment groups||2.1|-9.5|0.2105
70907493|NCT04675242|141303781|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.5936|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|adjusted for baseline eye dryness VAS score||Difference in the mean change from baseline||0.1|-0.2|0.5936
70907494|NCT01406717|141303820|OTHER||ANCOVA|0.0002|||||TWO_SIDED|95.0|-0.31377|0.31418||||||||0.31418|-0.31377|
70907495|NCT01406717|141303821|OTHER||ANCOVA|5.898|||||TWO_SIDED|95.0|-6.7565|18.5535||||||||18.5535|-6.7565|
70907496|NCT01406717|141303822|OTHER||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
70907497|NCT01406717|141303824|OTHER|||||||0.6318|||||||ANCOVA|||||||0.6318
70907498|NCT01406717|141303825|OTHER|||||||0.4887|||||||ANOVA|||||||0.4887
70907499|NCT01406717|141303826|OTHER|||||||0.3813|||||||ANOVA|||||||0.3813
70907500|NCT01406717|141303827|OTHER|||||||0.99|||||||ANOVA|||||||0.9900
70907501|NCT01406717|141303828|OTHER|||||||0.0017|||||||ANOVA|||||||0.0017
70907502|NCT01406717|141303829|OTHER|||||||0.6098|||||||Mantel Haenszel|||||||0.6098
70907503|NCT01406717|141303830|OTHER|||||||0.7324|||||||ANOVA|||||||0.7324
70907504|NCT01406717|141303831|OTHER|||||||0.2984|||||||ANOVA|||||||0.2984
70907505|NCT03257995|141303832|OTHER||Mean Difference (Final Values)|0.1861|||<|0.001|TWO_SIDED|95.0|0.1293|0.2429|||ANOVA|||||0.2429|0.1293|<0.001
70907506|NCT03257995|141303832|OTHER||Mean Difference (Final Values)|0.1463|||<|0.001|TWO_SIDED|95.0|0.0898|0.2029|||ANOVA|||||0.2029|0.0898|<0.001
70907507|NCT03257995|141303832|OTHER||Mean Difference (Final Values)|-0.0398|||||TWO_SIDED|95.0|-0.0942|0.0147|||ANOVA|||||0.0147|-0.0942|
70907508|NCT03257995|141303838|OTHER||Median Difference (Final Values)|-0.02||||0.823|TWO_SIDED|95.0|-0.83|0.33|||Wilcoxon (Mann-Whitney)|||||0.33|-0.83|0.823
70907509|NCT03257995|141303838|OTHER||Median Difference (Final Values)|-0.02||||0.801|TWO_SIDED|95.0|-0.82|0.51|||Wilcoxon (Mann-Whitney)|||||0.51|-0.82|0.801
70907510|NCT03257995|141303838|OTHER||Median Difference (Final Values)|0.0||||0.984|TWO_SIDED|95.0|-0.5|0.73|||Wilcoxon (Mann-Whitney)|||||0.73|-0.50|0.984
70907511|NCT03257995|141303839|OTHER||Mean Difference (Final Values)|0.2177|||<|0.001|TWO_SIDED|95.0|0.1482|0.2872|||ANOVA|||at 5 min||0.2872|0.1482|<0.001
70907512|NCT03257995|141303839|OTHER||Mean Difference (Final Values)|0.2724|||<|0.001|TWO_SIDED|95.0|0.203|0.3417|||ANOVA|||15min||0.3417|0.2030|<0.001
70907513|NCT03257995|141303839|OTHER||Mean Difference (Final Values)|0.273|||<|0.001|TWO_SIDED|95.0|0.2036|0.3423|||ANOVA|||30 min||0.3423|0.2036|<0.001
70907514|NCT03257995|141303839|OTHER||Mean Difference (Final Values)|0.2609|||<|0.001|TWO_SIDED|95.0|0.1915|0.3302|||ANOVA|||1 hour||0.3302|0.1915|<0.001
70907515|NCT03257995|141303839|OTHER||Mean Difference (Final Values)|0.2494|||<|0.001|TWO_SIDED|95.0|0.18|0.3188|||ANOVA|||2 hour||0.3188|0.1800|<0.001
70907516|NCT03257995|141303839|OTHER||Mean Difference (Final Values)|0.2273|||<|0.001|TWO_SIDED|95.0|0.1578|0.2968|||ANOVA|||4 hour||0.2968|0.1578|<0.001
70907517|NCT03257995|141303839|OTHER||Mean Difference (Final Values)|0.2396|||<|0.001|TWO_SIDED|95.0|0.1697|0.3096|||ANOVA|||8 hour||0.3096|0.1697|<0.001
70907518|NCT03257995|141303839|OTHER||Mean Difference (Final Values)|0.2443|||<|0.001|TWO_SIDED|95.0|0.1742|0.3144|||ANOVA|||12 hour||0.3144|0.1742|<0.001
70907519|NCT03257995|141303839|OTHER||Mean Difference (Final Values)|0.228|||<|0.001|TWO_SIDED|95.0|0.1563|0.2997|||ANOVA|||23 hour 15 min||0.2997|0.1563|<0.001
70907520|NCT03257995|141303839|OTHER||Mean Difference (Final Values)|0.1954|||<|0.001|TWO_SIDED|95.0|0.1237|0.2671|||ANOVA|||23 hour 45 min||0.2671|0.1237|<0.001
70907521|NCT03257995|141303839|OTHER||Mean Difference (Final Values)|0.2195|||<|0.001|TWO_SIDED|95.0|0.1502|0.2889|||ANOVA|||5 min||0.2889|0.1502|<0.001
70907522|NCT03257995|141303839|OTHER||Mean Difference (Final Values)|0.2684|||<|0.001|TWO_SIDED|95.0|0.1988|0.338|||ANOVA|||15 min||0.3380|0.1988|<0.001
70907523|NCT03257995|141303839|OTHER||Mean Difference (Final Values)|0.2572|||<|0.001|TWO_SIDED|95.0|0.1879|0.3266|||ANOVA|||30 min||0.3266|0.1879|<0.001
70907524|NCT03257995|141303839|OTHER||Mean Difference (Final Values)|0.2348|||<|0.001|TWO_SIDED|95.0|0.1656|0.304|||ANOVA|||1 hour||0.3040|0.1656|<0.001
70907525|NCT03257995|141303839|OTHER||Mean Difference (Final Values)|0.2546|||<|0.001|TWO_SIDED|95.0|0.1852|0.3239|||ANOVA|||2 hour||0.3239|0.1852|<0.001
70907526|NCT03257995|141303839|OTHER||Mean Difference (Final Values)|0.2322|||<|0.001|TWO_SIDED|95.0|0.1627|0.3017|||ANOVA|||4 hour||0.3017|0.1627|<0.001
70907527|NCT03257995|141303839|OTHER||Mean Difference (Final Values)|0.2324|||<|0.001|TWO_SIDED|95.0|0.1627|0.302|||ANOVA|||8 hour||0.3020|0.1627|<0.001
70907528|NCT03257995|141303839|OTHER||Mean Difference (Final Values)|0.2057|||<|0.001|TWO_SIDED|95.0|0.1359|0.2755|||ANOVA|||12 hour||0.2755|0.1359|<0.001
70907529|NCT03257995|141303839|OTHER||Mean Difference (Final Values)|0.1625|||<|0.001|TWO_SIDED|95.0|0.0912|0.2337|||ANOVA|||23 hour 15 min||0.2337|0.0912|<0.001
70907530|NCT03257995|141303839|OTHER||Mean Difference (Final Values)|0.1793|||<|0.001|TWO_SIDED|95.0|0.108|0.2505|||ANOVA|||23 hour 45 min||0.2505|0.1080|<0.001
70907531|NCT03257995|141303840|OTHER||Mean Difference (Final Values)|7.1|||<|0.001|TWO_SIDED|95.0|5.0|9.2|||ANOVA|||at 5 min||9.2|5.0|<.001
70907532|NCT03257995|141303840|OTHER||Mean Difference (Final Values)|8.5|||<|0.001|TWO_SIDED|95.0|6.4|10.6|||ANOVA|||at 15 min||10.6|6.4|<.001
70907533|NCT03257995|141303840|OTHER||Mean Difference (Final Values)|8.6|||<|0.001|TWO_SIDED|95.0|6.5|10.7|||ANOVA|||at 30||10.7|6.5|<0.001
70907534|NCT03257995|141303840|OTHER||Mean Difference (Final Values)|8.0|||<|0.001|TWO_SIDED|95.0|6.0|10.1|||ANOVA|||at 1 hour||10.1|6.0|<0.001
70907535|NCT03257995|141303840|OTHER||Mean Difference (Final Values)|7.6|||<|0.001|TWO_SIDED|95.0|5.5|9.7|||ANOVA|||at 2 hours||9.7|5.5|<0.001
70907536|NCT03257995|141303840|OTHER||Mean Difference (Final Values)|7.1|||<|0.001|TWO_SIDED|95.0|5.0|9.1|||ANOVA|||at 4 hours||9.1|5.0|<0.001
70907537|NCT03257995|141303840|OTHER||Mean Difference (Final Values)|7.3|||<|0.001|TWO_SIDED|95.0|5.2|9.4|||ANOVA|||at 8 hours||9.4|5.2|<0.001
70907538|NCT03257995|141303840|OTHER||Mean Difference (Final Values)|7.6|||<|0.001|TWO_SIDED|95.0|5.5|9.7|||ANOVA|||at 12 hours||9.7|5.5|<0.001
70907539|NCT03257995|141303840|OTHER||Mean Difference (Final Values)|7.0|||<|0.001|TWO_SIDED|95.0|4.8|9.1|||ANOVA|||at 23 hours 15 min||9.1|4.8|<0.001
70907540|NCT03257995|141303840|OTHER||Mean Difference (Final Values)|6.4|||<|0.001|TWO_SIDED|95.0|4.2|8.6|||ANOVA|||at 23 hours 45 min||8.6|4.2|<0.001
70907541|NCT03257995|141303840|OTHER||Mean Difference (Final Values)|7.1|||<|0.001|TWO_SIDED|95.0|5.0|9.2|||ANOVA|||at 5 min||9.2|5.0|<0.001
71030625|NCT01029353|141569490|SUPERIORITY|||||||||||||||||A Bayesian analysis among study survivors. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.99, 95% credible interval of (0.78, 1.25).|||
70907542|NCT03257995|141303840|OTHER||Mean Difference (Final Values)|8.3|||<|0.001|TWO_SIDED|95.0|6.2|10.4|||ANOVA|||at 15 min||10.4|6.2|<0.001
70907543|NCT03257995|141303840|OTHER||Mean Difference (Final Values)|8.1|||<|0.001|TWO_SIDED|95.0|6.0|10.2|||ANOVA|||at 30 min||10.2|6.0|<0.001
70907544|NCT03257995|141303840|OTHER||Mean Difference (Final Values)|7.4|||<|0.001|TWO_SIDED|95.0|5.3|9.4|||ANOVA|||at 1 hour||9.4|5.3|<0.001
70907545|NCT03257995|141303840|OTHER||Mean Difference (Final Values)|7.8|||<|0.001|TWO_SIDED|95.0|5.7|9.9|||ANOVA|||at 2 hours||9.9|5.7|<0.001
70907546|NCT03257995|141303840|OTHER||Mean Difference (Final Values)|7.3|||<|0.001|TWO_SIDED|95.0|5.2|9.4|||ANOVA|||at 4 hours||9.4|5.2|<0.001
70907547|NCT03257995|141303840|OTHER||Mean Difference (Final Values)|7.4|||<|0.001|TWO_SIDED|95.0|5.3|9.5|||ANOVA|||at 8 hours||9.5|5.3|<0.001
70907548|NCT03257995|141303840|OTHER||Mean Difference (Final Values)|6.3|||<|0.001|TWO_SIDED|95.0|4.2|8.4|||ANOVA|||at 12 hours||8.4|4.2|<0.001
70907549|NCT03257995|141303840|OTHER||Mean Difference (Final Values)|5.1|||<|0.001|TWO_SIDED|95.0|2.9|7.2|||ANOVA|||at 23 hours 15 min||7.2|2.9|<0.001
70907550|NCT03257995|141303840|OTHER||Mean Difference (Final Values)|5.9|||<|0.001|TWO_SIDED|95.0|3.7|8.0|||ANOVA|||at 23 hours 45 min||8.0|3.7|<0.001
70907551|NCT03257995|141303841|OTHER||Mean Difference (Final Values)|0.1866|||<|0.001|TWO_SIDED|95.0|0.1121|0.2611|||ANOVA|||5 min||0.2611|0.1121|<0.001
70907552|NCT03257995|141303841|OTHER||Mean Difference (Final Values)|0.2249|||<|0.001|TWO_SIDED|95.0|0.1506|0.2992|||ANOVA|||15 min||0.2992|0.1506|<0.001
70907553|NCT03257995|141303841|OTHER||Mean Difference (Final Values)|0.2404|||<|0.001|TWO_SIDED|95.0|0.1661|0.3148|||ANOVA|||30 min||0.3148|0.1661|<0.001
70907554|NCT03257995|141303841|OTHER||Mean Difference (Final Values)|0.2074|||<|0.001|TWO_SIDED|95.0|0.133|0.2817|||ANOVA|||1 hour||0.2817|0.1330|<0.001
70907555|NCT03257995|141303841|OTHER||Mean Difference (Final Values)|0.1802|||<|0.001|TWO_SIDED|95.0|0.1059|0.2545|||ANOVA|||2 hours||0.2545|0.1059|<0.001
70907556|NCT03257995|141303841|OTHER||Mean Difference (Final Values)|0.1621|||<|0.001|TWO_SIDED|95.0|0.0876|0.2366|||ANOVA|||4 hours||0.2366|0.0876|<0.001
70907557|NCT03257995|141303841|OTHER||Mean Difference (Final Values)|0.199|||<|0.001|TWO_SIDED|95.0|0.1239|0.2742|||ANOVA|||8 hours||0.2742|0.1239|<0.001
70907558|NCT03257995|141303841|OTHER||Mean Difference (Final Values)|0.1747|||<|0.001|TWO_SIDED|95.0|0.0994|0.2501|||ANOVA|||12 hours||0.2501|0.0994|<0.001
70907559|NCT03257995|141303841|OTHER||Mean Difference (Final Values)|0.1856|||<|0.001|TWO_SIDED|95.0|0.1081|0.2631|||ANOVA|||23 hours 15 min||0.2631|0.1081|<0.001
70907560|NCT03257995|141303841|OTHER||Mean Difference (Final Values)|0.1484|||<|0.001|TWO_SIDED|95.0|0.0709|0.2259|||ANOVA|||23 hours 45 min||0.2259|0.0709|<0.001
70907561|NCT03257995|141303841|OTHER||Mean Difference (Final Values)|0.213|||<|0.001|TWO_SIDED|95.0|0.1386|0.2873|||ANOVA|||5 min||0.2873|0.1386|<0.001
70907562|NCT03257995|141303841|OTHER||Mean Difference (Final Values)|0.2173|||<|0.001|TWO_SIDED|95.0|0.1426|0.292|||ANOVA|||15 min||0.2920|0.1426|<0.001
70907563|NCT03257995|141303841|OTHER||Mean Difference (Final Values)|0.2375|||<|0.001|TWO_SIDED|95.0|0.1632|0.3118|||ANOVA|||30 min||0.3118|0.1632|<0.001
70907564|NCT03257995|141303841|OTHER||Mean Difference (Final Values)|0.2013|||<|0.001|TWO_SIDED|95.0|0.1272|0.2754|||ANOVA|||1 hour||0.2754|0.1272|<0.001
70907565|NCT03257995|141303841|OTHER||Mean Difference (Final Values)|0.2005|||<|0.001|TWO_SIDED|95.0|0.1262|0.2749|||ANOVA|||2 hours||0.2749|0.1262|<0.001
70907566|NCT03257995|141303841|OTHER||Mean Difference (Final Values)|0.1946|||<|0.001|TWO_SIDED|95.0|0.1201|0.2691|||ANOVA|||4 hours||0.2691|0.1201|<0.001
70907567|NCT03257995|141303841|OTHER||Mean Difference (Final Values)|0.1937|||<|0.001|TWO_SIDED|95.0|0.119|0.2684|||ANOVA|||8 hours||0.2684|0.1190|<0.001
70907568|NCT03257995|141303841|OTHER||Mean Difference (Final Values)|0.1619|||<|0.001|TWO_SIDED|95.0|0.087|0.2369|||ANOVA|||12 hour||0.2369|0.0870|<0.001
70907569|NCT03257995|141303841|OTHER||Mean Difference (Final Values)|0.1249|||<|0.001|TWO_SIDED|95.0|0.048|0.2018|||ANOVA|||23 hour 15 min||0.2018|0.0480|<0.001
70907570|NCT03257995|141303841|OTHER||Mean Difference (Final Values)|0.1546|||<|0.001|TWO_SIDED|95.0|0.0777|0.2315|||ANOVA|||23 hour 45 min||0.2315|0.0777|<0.001
70907571|NCT03257995|141303842|OTHER||Mean Difference (Final Values)|5.0|||<|0.001|TWO_SIDED|95.0|3.1|7.0|||ANOVA|||5 min||7.0|3.1|<0.001
70907572|NCT03257995|141303842|OTHER||Mean Difference (Final Values)|6.0|||<|0.001|TWO_SIDED|95.0|4.0|7.9|||ANOVA|||15 min||7.9|4|<0.001
70907573|NCT03257995|141303842|OTHER||Mean Difference (Final Values)|6.6|||<|0.001|TWO_SIDED|95.0|4.6|8.5|||ANOVA|||30 min||8.5|4.6|<0.001
70907574|NCT03257995|141303842|OTHER||Mean Difference (Final Values)|5.5|||<|0.001|TWO_SIDED|95.0|3.5|7.4|||ANOVA|||1 hour||7.4|3.5|<0.001
70907575|NCT03257995|141303842|OTHER||Mean Difference (Final Values)|4.7|||<|0.001|TWO_SIDED|95.0|2.8|6.7|||ANOVA|||2 hour||6.7|2.8|<0.001
70907576|NCT03257995|141303842|OTHER||Mean Difference (Final Values)|4.3|||<|0.001|TWO_SIDED|95.0|2.3|6.3|||ANOVA|||4 hour||6.3|2.3|<0.001
70907577|NCT03257995|141303842|OTHER||Mean Difference (Final Values)|5.0|||<|0.001|TWO_SIDED|95.0|3.0|7.0|||ANOVA|||8 hour||7|3|<0.001
70907578|NCT03257995|141303842|OTHER||Mean Difference (Final Values)|4.5|||<|0.001|TWO_SIDED|95.0|2.5|6.5|||ANOVA|||12 hour||6.5|2.5|<0.001
70907579|NCT03257995|141303842|OTHER||Mean Difference (Final Values)|4.6|||<|0.001|TWO_SIDED|95.0|2.6|6.7|||ANOVA|||23 hour 15 min||6.7|2.6|<0.001
70907580|NCT03257995|141303842|OTHER||Mean Difference (Final Values)|4.1|||<|0.001|TWO_SIDED|95.0|2.0|6.2|||ANOVA|||23 hour 45 min||6.2|2.0|<0.001
70907581|NCT03257995|141303842|OTHER||Mean Difference (Final Values)|5.8|||<|0.001|TWO_SIDED|95.0|3.9|7.8|||ANOVA|||5 min||7.8|3.9|<0.001
70907582|NCT03257995|141303842|OTHER||Mean Difference (Final Values)|5.8|||<|0.001|TWO_SIDED|95.0|3.9|7.8|||ANOVA|||15 min||7.8|3.9|<0.001
70907583|NCT03257995|141303842|OTHER||Mean Difference (Final Values)|6.3|||<|0.001|TWO_SIDED|95.0|4.4|8.3|||ANOVA|||30 min||8.3|4.4|<0.001
70907584|NCT03257995|141303842|OTHER||Mean Difference (Final Values)|5.5|||<|0.001|TWO_SIDED|95.0|3.5|7.5|||ANOVA|||1 hour||7.5|3.5|<0.001
70907585|NCT03257995|141303842|OTHER||Mean Difference (Final Values)|5.5|||<|0.001|TWO_SIDED|95.0|3.5|7.4|||ANOVA|||2 hour||7.4|3.5|<0.001
70907586|NCT03257995|141303842|OTHER||Mean Difference (Final Values)|5.0|||<|0.001|TWO_SIDED|95.0|3.1|7.0|||ANOVA|||4 hour||7.0|3.1|<0.001
70907587|NCT03257995|141303842|OTHER||Mean Difference (Final Values)|5.0|||<|0.001|TWO_SIDED|95.0|3.0|7.0|||ANOVA|||8 hour||7.0|3.0|<0.001
70907588|NCT03257995|141303842|OTHER||Mean Difference (Final Values)|4.2|||<|0.001|TWO_SIDED|95.0|2.2|6.2|||ANOVA|||12 hour||6.2|2.2|<0.001
70907589|NCT03257995|141303842|OTHER||Mean Difference (Final Values)|3.0||||0.004|TWO_SIDED|95.0|1.0|5.0|||ANOVA|||23 hour 15 min||5.0|1.0|0.004
70907590|NCT03257995|141303842|OTHER||Mean Difference (Final Values)|4.1|||<|0.001|TWO_SIDED|95.0|2.1|6.1|||ANOVA|||23 hour 45 min||6.1|2.1|<0.001
70907591|NCT03257995|141303843|OTHER||Mean Difference (Final Values)|0.0249|||<|0.001|TWO_SIDED|95.0|0.0139|0.0359|||ANOVA|||5 min||0.0359|0.0139|<.001
70907592|NCT03257995|141303843|OTHER||Mean Difference (Final Values)|0.033|||<|0.001|TWO_SIDED|95.0|0.022|0.044|||ANOVA|||15 min||0.0440|0.0220|<.001
70907593|NCT03257995|141303843|OTHER||Mean Difference (Final Values)|0.0306|||<|0.001|TWO_SIDED|95.0|0.0197|0.0416|||ANOVA|||30 min||0.0416|0.0197|<0.001
70907594|NCT03257995|141303843|OTHER||Mean Difference (Final Values)|0.0324|||<|0.001|TWO_SIDED|95.0|0.0214|0.0434|||ANOVA|||1 hour||0.0434|0.0214|<0.001
70907595|NCT03257995|141303843|OTHER||Mean Difference (Final Values)|0.0338|||<|0.001|TWO_SIDED|95.0|0.0228|0.0447|||ANOVA|||2 hour||0.0447|0.0228|<0.001
70907596|NCT03257995|141303843|OTHER||Mean Difference (Final Values)|0.0325|||<|0.001|TWO_SIDED|95.0|0.0215|0.0435|||ANOVA|||4 hour||0.0435|0.0215|<0.001
70907597|NCT03257995|141303843|OTHER||Mean Difference (Final Values)|0.0311|||<|0.001|TWO_SIDED|95.0|0.02|0.0422|||ANOVA|||8 hour||0.0422|0.0200|<0.001
70907598|NCT03257995|141303843|OTHER||Mean Difference (Final Values)|0.0359|||<|0.001|TWO_SIDED|95.0|0.0248|0.047|||ANOVA|||12 hour||0.0470|0.0248|<0.001
70907599|NCT03257995|141303843|OTHER||Mean Difference (Final Values)|0.0326|||<|0.001|TWO_SIDED|95.0|0.0211|0.044|||ANOVA|||23 hour 15 min||0.0440|0.0211|<0.001
70907600|NCT03257995|141303843|OTHER||Mean Difference (Final Values)|0.0301|||<|0.001|TWO_SIDED|95.0|0.0187|0.0415|||ANOVA|||23 hour 45 min||0.0415|0.0187|<0.001
70907601|NCT03257995|141303843|OTHER||Mean Difference (Final Values)|0.0222|||<|0.001|TWO_SIDED|95.0|0.0113|0.0332|||ANOVA|||5 min||0.0332|0.0113|<0.001
70907602|NCT03257995|141303843|OTHER||Mean Difference (Final Values)|0.0344|||<|0.001|TWO_SIDED|95.0|0.0234|0.0454|||ANOVA|||15 min||0.0454|0.0234|<0.001
70907603|NCT03257995|141303843|OTHER||Mean Difference (Final Values)|0.029|||<|0.001|TWO_SIDED|95.0|0.018|0.0399|||ANOVA|||30 min||0.0399|0.0180|<0.001
70907604|NCT03257995|141303843|OTHER||Mean Difference (Final Values)|0.0278|||<|0.001|TWO_SIDED|95.0|0.0169|0.0387|||ANOVA|||1 hour||0.0387|0.0169|<0.001
70907605|NCT03257995|141303843|OTHER||Mean Difference (Final Values)|0.0338|||<|0.001|TWO_SIDED|95.0|0.0228|0.0447|||ANOVA|||2 hour||0.0447|0.0228|<0.001
70907606|NCT03257995|141303843|OTHER||Mean Difference (Final Values)|0.0278|||<|0.001|TWO_SIDED|95.0|0.0168|0.0387|||ANOVA|||4 hour||0.0387|0.0168|<0.001
70907607|NCT03257995|141303843|OTHER||Mean Difference (Final Values)|0.0316|||<|0.001|TWO_SIDED|95.0|0.0206|0.0426|||ANOVA|||8 hour||0.0426|0.0206|<0.001
70907608|NCT03257995|141303843|OTHER||Mean Difference (Final Values)|0.0285|||<|0.001|TWO_SIDED|95.0|0.0175|0.0396|||ANOVA|||12 hour||0.0396|0.0175|<0.001
70907609|NCT03257995|141303843|OTHER||Mean Difference (Final Values)|0.0281|||<|0.001|TWO_SIDED|95.0|0.0167|0.0394|||ANOVA|||23 hour 15 min||0.0394|0.0167|<0.001
70907610|NCT03257995|141303843|OTHER||Mean Difference (Final Values)|0.0266|||<|0.001|TWO_SIDED|95.0|0.0152|0.0379|||ANOVA|||23 hour 45 min||0.0379|0.0152|<0.001
70907611|NCT03257995|141303844|OTHER||Mean Difference (Final Values)|0.2025|||<|0.001|TWO_SIDED|95.0|0.1059|0.2952|||ANOVA|||5 min||0.2952|0.1059|<0.001
70907612|NCT03257995|141303844|OTHER||Mean Difference (Final Values)|0.2923|||<|0.001|TWO_SIDED|95.0|0.1979|0.3867|||ANOVA|||15 min||0.3867|0.1979|<0.001
70907613|NCT03257995|141303844|OTHER||Mean Difference (Final Values)|0.2657|||<|0.001|TWO_SIDED|95.0|0.1713|0.3601|||ANOVA|||30 min||0.3601|0.1713|<0.001
70907614|NCT03257995|141303844|OTHER||Mean Difference (Final Values)|0.2752|||<|0.001|TWO_SIDED|95.0|0.1808|0.3696|||ANOVA|||1 hour||0.3696|0.1808|<0.001
70907615|NCT03257995|141303844|OTHER||Mean Difference (Final Values)|0.2819|||<|0.001|TWO_SIDED|95.0|0.1875|0.3763|||ANOVA|||2 hours||0.3763|0.1875|<0.001
70907616|NCT03257995|141303844|OTHER||Mean Difference (Final Values)|0.282|||<|0.001|TWO_SIDED|95.0|0.1874|0.3766|||ANOVA|||4 hours||0.3766|0.1874|<0.001
70907617|NCT03257995|141303844|OTHER||Mean Difference (Final Values)|0.2538|||<|0.001|TWO_SIDED|95.0|0.1585|0.3492|||ANOVA|||8 hours||0.3492|0.1585|<0.001
70907618|NCT03257995|141303844|OTHER||Mean Difference (Final Values)|0.2687|||<|0.001|TWO_SIDED|95.0|0.1732|0.3643|||ANOVA|||12 hours||0.3643|0.1732|<0.001
70907619|NCT03257995|141303844|OTHER||Mean Difference (Final Values)|0.2453|||<|0.001|TWO_SIDED|95.0|0.1473|0.3434|||ANOVA|||23 hours 15 min||0.3434|0.1473|<0.001
70907620|NCT03257995|141303844|OTHER||Mean Difference (Final Values)|0.1862|||<|0.001|TWO_SIDED|95.0|0.0882|0.2842|||ANOVA|||23 hours 45 min||0.2842|0.0882|<0.001
70907621|NCT03257995|141303844|OTHER||Mean Difference (Final Values)|0.1956|||<|0.001|TWO_SIDED|95.0|0.1012|0.2899|||ANOVA|||5 min||0.2899|0.1012|<0.001
70907622|NCT03257995|141303844|OTHER||Mean Difference (Final Values)|0.2927|||<|0.001|TWO_SIDED|95.0|0.1979|0.3875|||ANOVA|||15 min||0.3875|0.1979|<0.001
70907623|NCT03257995|141303844|OTHER||Mean Difference (Final Values)|0.2723|||<|0.001|TWO_SIDED|95.0|0.178|0.3667|||ANOVA|||30 min||0.3667|0.1780|<0.001
70907624|NCT03257995|141303844|OTHER||Mean Difference (Final Values)|0.2386|||<|0.001|TWO_SIDED|95.0|0.1445|0.3328|||ANOVA|||1 hour||0.3328|0.1445|<0.001
70907625|NCT03257995|141303844|OTHER||Mean Difference (Final Values)|0.2986|||<|0.001|TWO_SIDED|95.0|0.2042|0.393|||ANOVA|||2 hours||0.3930|0.2042|<0.001
70907626|NCT03257995|141303844|OTHER||Mean Difference (Final Values)|0.2661|||<|0.001|TWO_SIDED|95.0|0.1715|0.3607|||ANOVA|||4 hours||0.3607|0.1715|<0.001
70907627|NCT03257995|141303844|OTHER||Mean Difference (Final Values)|0.2558|||<|0.001|TWO_SIDED|95.0|0.1609|0.3506|||ANOVA|||8 hours||0.3506|0.1609|<0.001
70907628|NCT03257995|141303844|OTHER||Mean Difference (Final Values)|0.1987|||<|0.001|TWO_SIDED|95.0|0.1036|0.2938|||ANOVA|||12 hours||0.2938|0.1036|<0.001
70907629|NCT03257995|141303844|OTHER||Mean Difference (Final Values)|0.2044|||<|0.001|TWO_SIDED|95.0|0.1071|0.3017|||ANOVA|||23 hours 15 min||0.3017|0.1071|<0.001
70907630|NCT03257995|141303844|OTHER||Mean Difference (Final Values)|0.1997|||<|0.001|TWO_SIDED|95.0|0.1023|0.297|||ANOVA|||23 hours 45 min||0.2970|0.1023|<0.001
70907631|NCT03257995|141303845|OTHER||Mean Difference (Final Values)|0.2476|||<|0.001|TWO_SIDED|95.0|0.1857|0.3095|||ANOVA|||||0.3095|0.1857|<.001
70907632|NCT03257995|141303845|OTHER||Mean Difference (Final Values)|0.2448|||<|0.001|TWO_SIDED|95.0|0.183|0.3066|||ANOVA|||||0.3066|0.1830|<.001
70907633|NCT03257995|141303845|OTHER||Mean Difference (Net)|-0.0028|||||TWO_SIDED|95.0|-0.0647|0.059|||ANOVA|||||0.0590|-0.0647|
70907634|NCT03257995|141303846|OTHER||Mean Difference (Final Values)|-0.42||||0.009|TWO_SIDED|95.0|-0.73|0.11|||ANOVA|||||0.11|-0.73|0.009
70907635|NCT03257995|141303846|OTHER||Mean Difference (Final Values)|-0.42||||0.008|TWO_SIDED|95.0|-0.73|0.11|||ANOVA|||||0.11|-0.73|0.008
70907636|NCT03257995|141303847|OTHER||Mean Difference (Final Values)|33.0|||<|0.001|TWO_SIDED|95.0|25.6|40.3|||ANOVA|||||40.3|25.6|<0.001
70907637|NCT03257995|141303847|OTHER||Mean Difference (Final Values)|30.8|||<|0.001|TWO_SIDED|95.0|23.5|38.2|||ANOVA|||||38.2|23.5|<0.001
70907638|NCT01556763|141303866|SUPERIORITY_OR_OTHER||||||=|0.1||95.0|||||ANCOVA|||Baseline value was the covariate and all values obtained during the treatment period were averaged together. This value was adjusted by regression against the baseline and estimation of a new value as if all subjects possessed the same baseline.||||=0.10
70907639|NCT01556763|141303867|SUPERIORITY_OR_OTHER||||||=|0.07||95.0|||||ANCOVA|||Baseline value was the covariate and all values obtained during the treatment period were averaged together. This value was adjusted by regression against the baseline and estimation of a new value as if all subjects possessed the same baseline.||||=0.07
70907640|NCT01556763|141303868|SUPERIORITY_OR_OTHER||||||=|0.02||95.0|||||ANCOVA|||Baseline value was the covariate and all values obtained during the treatment period were averaged together. This value was adjusted by regression against the baseline and estimation of a new value as if all subjects possessed the same baseline.||||=0.02
70907641|NCT01556763|141303869|SUPERIORITY_OR_OTHER||||||=|0.008||95.0|||||ANCOVA|||Baseline value was the covariate and all values obtained during the treatment period were averaged together. This value was adjusted by regression against the baseline and estimation of a new value as if all subjects possessed the same baseline.||||=0.008
70907642|NCT01370603|141303923|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence was declared if the 97.5% expanded confidence interval for the mean difference between the fixed-dose combination and co-administration in percent change from baseline was contained within ±4%.|Difference in Least-squares means|-0.2|||||TWO_SIDED|97.5|-1.9|1.4|||ANCOVA|||It was anticipated that 85% of the enrolled participants would be evaluable to achieve 95% power in order to establish equivalence between the Ezetimibe/Atorvastatin Fixed Dose Combination and the co-administration of Ezetimibe and Atorvastatin with respect to percent change from baseline in LDL-C after 6 weeks of treatment using two one-sided tests each at 2.5% α-level, assuming the underlying true treatment difference is ±1.08% and that the standard deviation of the difference is 12.8%.||1.4|-1.9|
70907643|NCT01370603|141303924|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares means|-0.1|||||TWO_SIDED|97.5|-1.4|1.2|||ANCOVA|||||1.2|-1.4|
70907644|NCT01370603|141303925|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares means|-0.3|||||TWO_SIDED|97.5|-1.8|1.2|||ANCOVA|||||1.2|-1.8|
70907645|NCT01370603|141303926|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-0.2|||||TWO_SIDED|97.5|-1.7|1.4|||ANCOVA|||||1.4|-1.7|
70907646|NCT01370603|141303927|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares means|-0.5|||||TWO_SIDED|97.5|-1.9|1.0|||ANCOVA|||||1.0|-1.9|
70907647|NCT01370603|141303928|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|0.0|||||TWO_SIDED|97.5|-4.9|4.9|||constrained Longitudinal Data Analysis|||||4.9|-4.9|
70907648|NCT04039503|141303931|SUPERIORITY||LS Mean Difference|-1.66|||<|0.001|TWO_SIDED|95.0|-1.88|-1.43|||Mixed Models Analysis|||||-1.43|-1.88|<0.001
70907649|NCT04039503|141303931|SUPERIORITY||LS Mean Difference|-1.65|||<|0.001|TWO_SIDED|95.0|-1.88|-1.43|||Mixed Models Analysis|||||-1.43|-1.88|<0.001
70907650|NCT04039503|141303932|SUPERIORITY||LS Mean Difference|-1.3|||<|0.001|TWO_SIDED|95.0|-1.52|-1.07|||Mixed Models Analysis|||||-1.07|-1.52|<0.001
70907651|NCT04039503|141303933|SUPERIORITY||LS Mean Difference|-7.8|||<|0.001|TWO_SIDED|95.0|-9.4|-6.3|||Mixed Models Analysis|||||-6.3|-9.4|<0.001
70907652|NCT04039503|141303933|SUPERIORITY||LS Mean Difference|-9.9|||<|0.001|TWO_SIDED|95.0|-11.5|-8.3|||Mixed Models Analysis|||||-8.3|-11.5|<0.001
70907653|NCT04039503|141303933|SUPERIORITY||LS Mean Difference|-12.6|||<|0.001|TWO_SIDED|95.0|-14.2|-11.0|||Mixed Models Analysis|||||-11.0|-14.2|<0.001
70907654|NCT04039503|141303934|SUPERIORITY||Odds Ratio (OR)|37.77|||<|0.001|TWO_SIDED|95.0|15.23|93.7|||Regression, Logistic|||||93.70|15.23|<0.001
70907655|NCT04039503|141303934|SUPERIORITY||Odds Ratio (OR)|100.07|||<|0.001|TWO_SIDED|95.0|30.02|333.62|||Regression, Logistic|||||333.62|30.02|<0.001
70907656|NCT04039503|141303934|SUPERIORITY||Odds Ratio (OR)|43.31|||<|0.001|TWO_SIDED|95.0|16.92|110.83|||Regression, Logistic|||||110.83|16.92|<0.001
70907657|NCT04039503|141303935|SUPERIORITY||LS Mean Difference|-22.5|||<|0.001|TWO_SIDED|95.0|-29.5|-15.4|||Mixed Models Analysis|||||-15.4|-29.5|<0.001
70907658|NCT04039503|141303935|SUPERIORITY||LS Mean Difference|-29.0|||<|0.001|TWO_SIDED|95.0|-36.0|-22.0|||Mixed Models Analysis|||||-22.0|-36.0|<0.001
70907659|NCT04039503|141303935|SUPERIORITY||LS Mean Difference|-28.8|||<|0.001|TWO_SIDED|95.0|-35.9|-21.6|||Mixed Models Analysis|||||-21.6|-35.9|<0.001
70907660|NCT04039503|141303937|SUPERIORITY||Odds Ratio (OR)|17.15|||<|0.001|TWO_SIDED|95.0|7.55|38.93|||Regression, Logistic|||||38.93|7.55|<0.001
70907661|NCT04039503|141303937|SUPERIORITY||Odds Ratio (OR)|27.24|||<|0.001|TWO_SIDED|95.0|11.87|62.55|||Regression, Logistic|||||62.55|11.87|<0.001
70907662|NCT04039503|141303937|SUPERIORITY||Odds Ratio (OR)|79.61|||<|0.001|TWO_SIDED|95.0|32.76|193.44|||Regression, Logistic|||||193.44|32.76|<0.001
70907663|NCT04039503|141303938|SUPERIORITY||Estimate Difference|-35.4|||||TWO_SIDED|95.0|-46.0|-22.8||||||||-22.8|-46.0|
70907664|NCT04039503|141303938|SUPERIORITY||Estimate Difference|-38.2|||||TWO_SIDED|95.0|-48.3|-26.1||||||||-26.1|-48.3|
70907665|NCT04039503|141303938|SUPERIORITY||Estimate Difference|-49.3|||||TWO_SIDED|95.0|-57.7|-39.4||||||||-39.4|-57.7|
70907666|NCT04039503|141303941|SUPERIORITY||Odds Ratio (OR)|12.22|||<|0.001|TWO_SIDED|95.0|3.93|38.0|||Regression, Logistic|||||38.00|3.93|<0.001
70907667|NCT04039503|141303941|SUPERIORITY||Odds Ratio (OR)|32.36|||<|0.001|TWO_SIDED|95.0|10.52|99.49|||Regression, Logistic|||||99.49|10.52|<0.001
70907668|NCT04039503|141303941|SUPERIORITY||Odds Ratio (OR)|56.26|||<|0.001|TWO_SIDED|95.0|18.27|173.26|||Regression, Logistic|||||173.26|18.27|<0.001
70907669|NCT00654940|141303957|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.305||||80.0|-1.21|-0.41|||ANCOVA|||Treatment comparison of pregabalin - placebo: mixed effects analysis of covariance model fitted on the full analysis set population, accounting for period and treatment effects. Subject was fitted as a random effect, and baseline was fitted as two covariates.||-0.41|-1.21|
70907670|NCT00654940|141303958|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|2.493||||80.0|-3.82|2.78|||ANCOVA|||Neuropathic Pain Symptom Inventory treatment comparison: Pregabalin - Placebo. Total score was analyzed using a mixed effect analysis of covariance model based on the full analysis set (FAS), accounting for period and treatment effects. Subject was fitted as a random effect and baseline was fitted as two covariates.||2.78|-3.82|
70907671|NCT00654940|141303959|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29000.0|STANDARD_ERROR_OF_MEAN|17000.0||||80.0|6100.0|51000.0|||ANCOVA|||Difference in least squares means Pregabalin-Placebo. Model of day (8 am to 8 pm) total activity score at end of treatment. Mixed effects analysis of covariance model was fitted on the full analysis set population, accounting for period and treatment effects. Subject was fitted as a random effect and baseline was fitted as two covariates.||51000|6100|
70907672|NCT00619476|141303964|SUPERIORITY_OR_OTHER||Adjusted Mean difference versus placebo|-0.81||||0.013|TWO_SIDED|95.0|-1.4|-0.23||This p-value has been adjusted for multiplicity using a step-down procedure that uses Dunnett's test within a closed testing scheme for multiple comparisons with a common control in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|An ANCOVA model with body mass index (BMI), baseline 24-hour average pain intensity, and grouped center as covariates was used.||||-0.23|-1.40|0.013
70907673|NCT00619476|141303964|SUPERIORITY_OR_OTHER||Adjusted Mean difference versus placebo|-0.7||||0.029|TWO_SIDED|95.0|-1.33|-0.07||This p-value has been adjusted for multiplicity using a step-down procedure that uses Dunnett's test within a closed testing scheme for multiple comparisons with a common control in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|An ANCOVA model with body mass index (BMI), baseline 24-hour average pain intensity, and grouped center as covariates was used.||||-0.07|-1.33|0.029
70907674|NCT00619476|141303964|SUPERIORITY_OR_OTHER||Adjusted Mean difference versus placebo|-1.07||||0.002|TWO_SIDED|95.0|-1.68|-0.45||This p-value has been adjusted for multiplicity using a step-down procedure that uses Dunnett's test within a closed testing scheme for multiple comparisons with a common control in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|An ANCOVA model with body mass index (BMI), baseline 24-hour average pain intensity, and grouped center as covariates was used.||||-0.45|-1.68|0.002
70907675|NCT04834362|141303999|OTHER|||||||0.677|||||||t-test, 2 sided|||||||0.677
70907676|NCT04834362|141304000|OTHER|||||||0.053|||||||t-test, 2 sided|||||||0.053
70907677|NCT04834362|141304001|OTHER|||||||0.918|||||||t-test, 2 sided|||||||0.918
70907678|NCT04834362|141304002|OTHER|||||||0.729|||||||Chi-squared|||||||0.729
70907679|NCT01811563|141304060|EQUIVALENCE|Main effect for implant independent of time||||||0.661|||||||ANOVA|||||||0.661
70907680|NCT01811563|141304060|EQUIVALENCE|Main effect for time independent of implant|||||<|0.001|||||||ANOVA|||||||<0.001
70907681|NCT01811563|141304060|EQUIVALENCE|Interaction between implant and time||||||0.27|||||||ANOVA|||||||0.270
70907682|NCT01811563|141304061|EQUIVALENCE|Main effect for implant independent of time||||||0.856|||||||ANOVA|Main effect for implant, LQ-YBT Baseline to 52 weeks||||||0.856
70907683|NCT01811563|141304061|EQUIVALENCE|Time independent of implant, Baseline to 52 Weeks|||||<|0.001|||||||ANOVA|||||||<0.001
70907684|NCT01811563|141304061|EQUIVALENCE|Implant by Time interaction, Baseline to 52 Weeks between Zimmer and Stryker||||||0.822|||||||ANOVA|||||||0.822
70907685|NCT01811563|141304062|EQUIVALENCE|Main effect for implant, Baseline to 52 weeks||||||0.158|||||||ANOVA|||||||.158
70907686|NCT01811563|141304062|EQUIVALENCE|Main effect for time, Baseline to 52 weeks|||||<|0.001|||||||ANOVA|||||||<0.001
70907687|NCT01811563|141304062|EQUIVALENCE|Interaction of time by implant, Baseline to 52 weeks||||||0.365|||||||ANOVA|||||||0.365
70907688|NCT01811563|141304064|EQUIVALENCE|Main effect for implant, baseline to 52 weeks||||||0.416|||||||ANOVA|||||||.416
70907689|NCT01811563|141304064|EQUIVALENCE|Main effect for time, Baseline to 52 weeks|||||<|0.001|||||||ANOVA|||||||<0.001
70907690|NCT01811563|141304064|EQUIVALENCE|Implant by time interaction, baseline to 52 weeks||||||0.917|||||||ANOVA|||||||0.917
70907691|NCT01811563|141304066|EQUIVALENCE|Main effect by implant, Baseline to 52 weeks||||||0.83|||||||ANOVA|||||||0.830
70907692|NCT01811563|141304066|EQUIVALENCE|Main effect by time, baseline to 52 weeks|||||<|0.001|||||||ANOVA|||||||<0.001
70907693|NCT01811563|141304066|EQUIVALENCE|Interaction between implant and time, baseline to 52 weeks||||||0.728|||||||ANOVA|||||||0.728
70907694|NCT01811563|141304067|EQUIVALENCE|Between implants at 6 weeks||||||0.319|||||||t-test, 2 sided|||||||0.319
70907695|NCT01807221|141304079|OTHER||Mean Difference (Final Values)|-6.3||||0.8771|TWO_SIDED|90.0|-14.9|2.3|||Chi-squared|||Estimates and two-sided 90% confidence intervals are provided for each treatment group and for the treatment differences πBi - πC. Clopper-Pearson confidence intervals were calculated for each treatment group, while for treatment differences the exact unconditional confidence limits were calculated.||2.3|-14.9|0.8771
70907696|NCT01807221|141304079|OTHER||Mean Difference (Final Values)|-4.7||||0.7945|TWO_SIDED|90.0|-13.4|4.0|||Chi-squared|||Estimates and two-sided 90% confidence intervals are provided for each treatment group and for the treatment differences πBi - πC. Clopper-Pearson confidence intervals were calculated for each treatment group, while for treatment differences the exact unconditional confidence limits were calculated.||4|-13.4|0.7945
70907697|NCT01807221|141304079|OTHER||Mean Difference (Final Values)|0.1||||0.5|TWO_SIDED|90.0|-8.5|8.8|||Chi-squared|||Estimates and two-sided 90% confidence intervals are provided for each treatment group and for the treatment differences πBi - πC. Clopper-Pearsonconfidence intervals were calculated for each treatment group, while for treatment differences the exact unconditional confidence limits were calculated.||8.8|-8.5|0.5
70907698|NCT01807221|141304079|OTHER||Mean Difference (Final Values)|1.6||||0.4225|TWO_SIDED|90.0|-7.1|10.2|||Chi-squared|||Estimates and two-sided 90% confidence intervals are provided for each treatment group and for the treatment differences πBi - πC. Clopper-Pearsonconfidence intervals were calculated for each treatment group, while for treatment differences the exact unconditional confidence limits were calculated.||10.2|-7.1|0.4225
70907699|NCT01807221|141304079|OTHER||Mean Difference (Final Values)|-3.0||||0.6865|TWO_SIDED|90.0|-11.7|5.7|||Chi-squared|||Estimates and two-sided 90% confidence intervals are provided for each treatment group and for the treatment differences πBi - πC. Clopper-Pearson confidence intervals were calculated for each treatment group, while for treatment differences the exact unconditional confidence limits were calculated.||5.7|-11.7|0.6865
70907700|NCT02609659|141304091|NON_INFERIORITY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the 3-DAA + RBV 600 mg treatment group as compared with the historical rate for 3-DAA + weight-based RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 92% to achieve noninferiority.|percentage of participants|89.5|||||TWO_SIDED|95.0|83.7|95.4||||||||95.4|83.7|
70907701|NCT00900627|141304123|SUPERIORITY_OR_OTHER||Maximum Tolerated Dose|40.0|||||||||||||Dosing started at 160mg. Based on the data seen, 240mg with 33% patients with DLTs, 120mg with 50% patients with DLTs, 80mg with 33% of patients with DLTs and 40mg with 0% patients with DLTs, 40mg was deemed the maximum tolerated dose.|A tolerated dose was defined as one where ≤25% of the patients experienced a DLT. If a dose was tolerated, an increased dose was to be investigated in another group of 3-6 evaluable patients. A non-tolerated dose was defined as one where \>25% of the patients experience a DLT. If a dose was non tolerated, a decreased/intermediate dose could be investigated in another group of 3-6 evaluable patients. The maximum tolerated dose was determined as the maximum dose level that was defined as tolerated.||||
70907702|NCT00900627|141304124|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.679|TWO_SIDED|95.0|0.76|1.52||Statistical significance threshold at this analysis was 5%|Cox Proportional Hazard model|Cox PH test with terms for treatment , prior taxane, hormone receptor status, prior chemotherapy for breast cancer and AZD8931 diagnostic test|The Hazard Ratio is for AZD8931 40mg + paclitaxel / Placebo + paclitaxel, ie a hazard ratio \<1 favours AZD8931 40mg + paclitaxel|Originally, 166 patients were to be randomised to observe at least 133 progression events, based on HR=0.67, 80% power, 2-sided 5% significant level and a median of 6 months for the placebo arm. After 190 patients were randomised, the analysis was agreed to be performed at an similar level of maturity (70%) as originally planned (72%), after approximately 133 events.||1.52|0.76|0.679
70907703|NCT00900627|141304125|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.02||||0.026|TWO_SIDED|95.0|1.09|3.75||Statistical significance threshold at this analysis was 5%|Logistic Regression|Logistic reg. model with terms for treatment, prior taxane, hormone receptor status, prior chemotherapy for breast cancer and AZD8931 diagnostic test|The odds Ratio is for AZD8931 40mg + paclitaxel / Placebo + paclitaxel, ie a odds ratio \<1 favours AZD8931 40mg + paclitaxel|Originally, 166 patients were to be randomised to observe at least 133 progression events, based on HR=0.67, 80% power, 2-sided 5% significant level and a median of 6 months for the placebo arm. After 190 patients were randomised, the analysis was agreed to be performed at an similar level of maturity (70%) as originally planned (72%), after approximately 133 events.||3.75|1.09|0.026
70907704|NCT00900627|141304126|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.607|TWO_SIDED|95.0|0.67|2.01||Statistical significance threshold at this analysis was 5%|Cox proportional hazard model|Cox PH test with terms for treatment , prior taxane, hormone receptor status, prior chemotherapy for breast cancer|The Hazard Ratio is for AZD8931 40mg + paclitaxel / Placebo + paclitaxel, ie a hazard ratio \<1 favours AZD8931 40mg + paclitaxel|Originally, 166 patients were to be randomised to observe at least 133 progression events, based on HR=0.67, 80% power, 2-sided 5% significant level and a median of 6 months for the placebo arm. After 190 patients were randomised, the analysis was agreed to be performed at an similar level of maturity (70%) as originally planned (72%), after approximately 133 events.||2.01|0.67|0.607
70907705|NCT02291289|141304129|SUPERIORITY||Hazard Ratio (HR)|0.95|||=|0.872|TWO_SIDED|95.0|0.5|1.82|||Log Rank|||||1.82|0.50|= 0.872
70907706|NCT02291289|141304129|SUPERIORITY||Hazard Ratio (HR)|0.95|||=|0.666|TWO_SIDED|95.0|0.77|1.18|||Log Rank|||||1.18|0.77|= 0.666
70907707|NCT02291289|141304129|SUPERIORITY||Hazard Ratio (HR)|1.44|||=|0.128|TWO_SIDED|95.0|0.9|2.29|||Log Rank|||||2.29|0.90|= 0.128
70907708|NCT02291289|141304130|SUPERIORITY||Hazard Ratio (HR)|0.71|||=|0.276|TWO_SIDED|95.0|0.39|1.32|||Log Rank|||||1.32|0.39|= 0.276
70907709|NCT02291289|141304130|SUPERIORITY||Hazard Ratio (HR)|0.81|||=|0.076|TWO_SIDED|95.0|0.64|1.02|||Log Rank|||||1.02|0.64|= 0.076
70907710|NCT02291289|141304130|SUPERIORITY||||||=|0.157|||||||Log Rank|||||||= 0.157
70907711|NCT02291289|141304130|SUPERIORITY||Hazard Ratio (HR)|1.25|||=|0.415|TWO_SIDED|95.0|0.73|2.14|||Log Rank|||||2.14|0.73|= 0.415
70907712|NCT02291289|141304132|SUPERIORITY||||||=|0.064|||||||Chi-squared|||||||= 0.064
70907713|NCT02291289|141304132|SUPERIORITY||||||=|0.658|||||||Chi-squared|||||||= 0.658
70907714|NCT02291289|141304132|SUPERIORITY|||||||0.093|||||||Chi-squared|||||||0.093
70907715|NCT02291289|141304133|SUPERIORITY||||||=|0.125|||||||Chi-squared|||||||= 0.125
70907716|NCT02291289|141304133|SUPERIORITY||||||=|0.739|||||||Chi-squared|||||||= 0.739
70907717|NCT02291289|141304133|SUPERIORITY|||||||0.362|||||||Chi-squared|||||||0.362
70907718|NCT02291289|141304135|SUPERIORITY||||||=|0.421|||||||Log Rank|||||||= 0.421
70907719|NCT02291289|141304135|SUPERIORITY||||||=|0.495|||||||Log Rank|||||||= 0.495
70907720|NCT02291289|141304135|SUPERIORITY|||||||0.357|||||||Log Rank|||||||0.357
70907721|NCT02802020|141304137|SUPERIORITY|||||||0.999|||||||Fisher Exact|||"We hypothesized that pain reduction (as defined in Study endpoints above) would be achieved in a performance goal of at least 53% of patients receiving the study SEMS. Assuming an observed pain reduction rate of 75% and using an exact test with a one-sided alpha of 0.025, 43 patients were required to obtain power of at least 80%."||||0.999
70907722|NCT02802020|141304138|SUPERIORITY|we hypothesized that the proportion of patients reporting one or more related SAE(s) would be below a performance goal of 32%. Assuming an observed SAE rate of 15% and using an exact test with one-sided alpha of 0.025, 57 patients were required to obtain power of at least 80%.||||||0.513|||||||Fisher Exact|||||||0.513
70907723|NCT00962585|141304156|SUPERIORITY_OR_OTHER|||||||0.573||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|ANCOVA|"Model (Analysis of covariance): Week 4 = Baseline (MSVS) + Treatment + Site~Difference Between Means: S-equol treatment group - Placebo"||"\# of MSVS per week at each protocol visits = (# of Moderate+Severe hot flushes)/(Current protocol visit date-Previous protocol visit date (days)) x 7.~The ANCOVA procedure was used to test the following hypotheses:~H0: μ1 = μp versus HA: μ1 ≠ μp where μ1 and μp denote the mean frequency of MSVS (at Week 4 in case of primary efficacy endpoint), adjusted for Baseline MSVS values, in the treatment and placebo groups, respectively."||||0.5730
70907724|NCT00962585|141304156|SUPERIORITY_OR_OTHER||LS means difference|1.13|||>|0.05|TWO_SIDED|95.0|-10.06|12.32|||Pair-wise comparisons|||||12.32|-10.06|>0.05
70907725|NCT00962585|141304156|SUPERIORITY_OR_OTHER||LS means difference|6.98|||>|0.05|TWO_SIDED|95.0|-3.87|17.84|||Pair-wise comparisons|||||17.84|-3.87|>0.05
70907726|NCT00962585|141304156|SUPERIORITY_OR_OTHER||LS means difference|0.94|||>|0.05|TWO_SIDED|95.0|-10.16|12.04|||Pair-wise comparisons|||||12.04|-10.16|>0.05
70907727|NCT00962585|141304157|SUPERIORITY_OR_OTHER|||||||0.7364||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|ANCOVA|"Model: Week 4 = Baseline (MSVS) + Treatment + Site~Difference Between Means: S-equol treatment group - Placebo"||"\# of MSVS per week at each protocol visits = (# of Moderate+Severe hot flushes)/(Current protocol visit date-Previous protocol visit date (days)) x 7~1-week period = remaining days of the period since the last visit (i.e. period following first 7 days, as per CRF)"||||0.7364
70907728|NCT00962585|141304157|SUPERIORITY_OR_OTHER||LS means difference|-0.19|||>|0.05|TWO_SIDED|95.0|-12.38|12.01|||Pair-wise comparisons|||||12.01|-12.38|>0.05
70907729|NCT00962585|141304157|SUPERIORITY_OR_OTHER||LS means difference|4.77|||>|0.05|TWO_SIDED|95.0|-6.94|16.48|||Pair-wise comparisons|||||16.48|-6.94|>0.05
70907730|NCT00962585|141304157|SUPERIORITY_OR_OTHER||LS means difference|-1.63|||>|0.05|TWO_SIDED|95.0|-13.41|10.15|||Pair-wise comparisons|||||10.15|-13.41|>0.05
70907731|NCT00962585|141304158|SUPERIORITY_OR_OTHER|||||||0.1217||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05. Treatment effect averaged across Weeks 1 and 2.|Repeated measures ANCOVA|"Mixed Model: MSVS = Baseline (MSVS) + Treatment + Site + Weeks + Treatment x Weeks~Difference Between Means: S-equol treatment group - Placebo"||\# of MSVS per week at each protocol visits = (# of Moderate+Severe hot flushes)/(Current protocol visit date-Previous protocol visit date (days)) x 7.||||0.1217
70907732|NCT00962585|141304158|SUPERIORITY_OR_OTHER||LS means difference|-3.77|||>|0.05||95.0|-12.69|5.16|||Pair-wise comparisons|||Week 1, Treatment Effect||5.16|-12.69|>0.05
70907733|NCT00962585|141304158|SUPERIORITY_OR_OTHER||LS means difference|9.69|||<|0.05|TWO_SIDED|95.0|0.79|18.6|||Pair-wise comparisons|||Week 1, Treatment Effect||18.60|0.79|<0.05
70907734|NCT00962585|141304158|SUPERIORITY_OR_OTHER||LS means difference|1.31|||>|0.05|TWO_SIDED|95.0|-7.73|10.36|||Pair-wise comparisons|||Week 1, Treatment Effect||10.36|-7.73|>0.05
70907735|NCT00962585|141304158|SUPERIORITY_OR_OTHER||LS means difference|-6.7|||>|0.05|TWO_SIDED|95.0|-18.36|4.96|||Pair-wise comparisons|||Week 2, Treatment Effect||4.96|-18.36|>0.05
70907736|NCT00962585|141304158|SUPERIORITY_OR_OTHER||LS means difference|3.56|||>|0.05|TWO_SIDED|95.0|-8.01|15.14|||Pair-wise comparisons|||Week 2, Treatment Effect||15.14|-8.01|>0.05
70907737|NCT00962585|141304158|SUPERIORITY_OR_OTHER||LS means difference|0.91|||>|0.05|TWO_SIDED|95.0|-10.77|12.58|||Pair-wise comparisons|||Week 2, Treatment Effect||12.58|-10.77|>0.05
70907738|NCT00962585|141304159|SUPERIORITY_OR_OTHER|||||||0.1609||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05. Treatment effect averaged across Weeks 1, 2 and 4.|Repeated measures ANCOVA|Mixed Model: Severity of VMS = Baseline (severity of VMS) + Treatment + Site + Weeks + Treatment x Weeks||Severity of VMS per week at each protocol visits = (Sum of scores of Mild, Moderate, Severe hot flushes)/(Current protocol visit date-Previous protocol visit date (days)) x 7, where severity of vasomotor symptoms are scored as: 1 = mild, 2 = moderate and 3 = severe.||||0.1609
70907739|NCT00962585|141304159|SUPERIORITY_OR_OTHER||LS means difference|-6.34|||>|0.05|TWO_SIDED|95.0|-26.41|13.73|||Pair-wise comparisons|||Week 1, Treatment Effect||13.73|-26.41|>0.05
70907740|NCT00962585|141304159|SUPERIORITY_OR_OTHER||LS means difference|25.67|||<|0.05|TWO_SIDED|95.0|5.64|45.69|||Pair-wise comparisons|||Week 1, Treatment Effect||45.69|5.64|<0.05
70907741|NCT00962585|141304159|SUPERIORITY_OR_OTHER||LS means difference|2.09|||>|0.05|TWO_SIDED|95.0|-18.21|22.39|||Pair-wise comparisons|||Week 1, Treatment Effect||22.39|-18.21|>0.05
70907742|NCT00962585|141304159|SUPERIORITY_OR_OTHER||LS means difference|-16.14|||>|0.05|TWO_SIDED|95.0|-43.29|11.01|||Pair-wise comparisons|||Week 2, Treatment Effect||11.01|-43.29|>0.05
70907743|NCT00962585|141304159|SUPERIORITY_OR_OTHER||LS means difference|8.73|||>|0.05|TWO_SIDED|95.0|-18.19|35.65|||Pair-wise comparisons|||Week 2, Treatment Effect||35.65|-18.19|>0.05
70907744|NCT00962585|141304159|SUPERIORITY_OR_OTHER||LS means difference|-0.65|||>|0.05|TWO_SIDED|95.0|-27.8|26.5|||Pair-wise comparisons|||Week 2, Treatment Effect||26.50|-27.80|>0.05
70907745|NCT00962585|141304159|SUPERIORITY_OR_OTHER||LS means difference|-1.69|||>|0.05|TWO_SIDED|95.0|-28.68|25.3|||Pair-wise comparisons|||Week 4, Treatment Effect||25.30|-28.68|>0.05
70907746|NCT00962585|141304159|SUPERIORITY_OR_OTHER||LS means difference|16.15|||>|0.05|TWO_SIDED|95.0|-10.4|42.71|||Pair-wise comparisons|||Week 4, Treatment Effect||42.71|-10.40|>0.05
70907747|NCT00962585|141304159|SUPERIORITY_OR_OTHER||LS means difference|-1.29|||>|0.05|TWO_SIDED|95.0|-28.18|25.6|||Pair-wise comparisons|||Week 4, Treatment Effect||25.60|-28.18|>0.05
70907748|NCT00962585|141304160|SUPERIORITY_OR_OTHER|||||||0.2211||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05. Treatment effect averaged across Weeks 2 and 4.|Repeated measures ANCOVA|Mixed Model: (Vaginal pH) = Baseline (Vaginal pH) + Treatment + Site + Weeks + Treatment x Weeks||||||0.2211
70907749|NCT00962585|141304160|SUPERIORITY_OR_OTHER||LS means difference|-0.21|||>|0.05|TWO_SIDED|95.0|-0.53|0.12|||Pair-wise comparisons|||Week 2, Treatment Effect||0.12|-0.53|>0.05
70907750|NCT00962585|141304160|SUPERIORITY_OR_OTHER||LS means difference|-0.23|||>|0.05|TWO_SIDED|95.0|-0.55|0.09|||Pair-wise comparisons|||Week 2, Treatment Effect||0.09|-0.55|>0.05
70907751|NCT00962585|141304160|SUPERIORITY_OR_OTHER||LS means difference|0.03|||>|0.05|TWO_SIDED|95.0|-0.28|0.35|||Pair-wise comparisons|||Week 2, Treatment Effect||0.35|-0.28|>0.05
70907752|NCT00962585|141304160|SUPERIORITY_OR_OTHER||LS means difference|-0.26|||>|0.05|TWO_SIDED|95.0|-0.54|0.02|||Pair-wise comparisons|||Week 4, Treatment Effect||0.02|-0.54|>0.05
70907753|NCT00962585|141304160|SUPERIORITY_OR_OTHER||LS means difference|-0.13|||>|0.05|TWO_SIDED|95.0|-0.4|0.14|||Pair-wise comparisons|||Week 4, Treatment Effect||0.14|-0.40|>0.05
70907754|NCT00962585|141304160|SUPERIORITY_OR_OTHER||LS means difference|-0.24|||>|0.05|TWO_SIDED|95.0|-0.51|0.03|||Pair-wise comparisons|||Week 4, Treatment Effect||0.03|-0.51|>0.05
70907755|NCT00962585|141304161|SUPERIORITY_OR_OTHER|||||||0.6375||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05. Treatment effect averaged across Weeks 2 and 4.|Repeated measures ANCOVA|Mixed Model: (Vaginal Maturation Index) = Baseline (Vaginal Maturation Index) + Treatment + Site + Weeks + Treatment x Weeks||Vaginal maturation index = 0.2 x (% parabasal cells) + 0.6 x(% intermediate cells) + 1.0 x (% superficial cells)||||0.6375
70907756|NCT00962585|141304161|SUPERIORITY_OR_OTHER||LS means difference|-1.58|||>|0.05|TWO_SIDED|95.0|-9.57|6.42|||Pair-wise comparisons|||Week 2, Treatment Effect||6.42|-9.57|>0.05
70907757|NCT00962585|141304161|SUPERIORITY_OR_OTHER||LS means difference|-1.58|||>|0.05|TWO_SIDED|95.0|-9.63|6.46|||Pair-wise comparisons|||Week 2, Treatment Effect||6.46|-9.63|>0.05
70907758|NCT00962585|141304161|SUPERIORITY_OR_OTHER||LS means difference|-1.59|||>|0.05|TWO_SIDED|95.0|-9.66|6.47|||Pair-wise comparisons|||Week 2, Treatment Effect||6.47|-9.66|>0.05
70907759|NCT00962585|141304161|SUPERIORITY_OR_OTHER||LS means difference|-0.31|||>|0.05|TWO_SIDED|95.0|-6.73|6.11|||Pair-wise comparisons|||Week 4, Treatment Effect||6.11|-6.73|>0.05
70907760|NCT00962585|141304161|SUPERIORITY_OR_OTHER||LS means difference|-6.14|||>|0.05|TWO_SIDED|95.0|-12.36|0.07|||Pair-wise comparisons|||Week 4, Treatment Effect||0.07|-12.36|>0.05
70907761|NCT00962585|141304161|SUPERIORITY_OR_OTHER||LS means difference|-2.88|||>|0.05|TWO_SIDED|95.0|-9.05|3.28|||Pair-wise comparisons|||Week 4, Treatment Effect||3.28|-9.05|>0.05
70907762|NCT00962585|141304162|SUPERIORITY_OR_OTHER|||||||0.0681||||||P-value is adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05. Treatment effect averaged across Weeks 2 and 4.|Repeated measures ANCOVA|Mixed Model: (Estradiol) = Baseline (Estradiol) + Treatment + Site + Weeks + Treatment x Weeks||||||0.0681
70907763|NCT00962585|141304162|SUPERIORITY_OR_OTHER||LS means difference|35.32|||>|0.05|TWO_SIDED|95.0|1.75|68.9|||Pair-wise comparisons|||Week 2, Treatment Effect||68.90|1.75|>0.05
70907764|NCT00962585|141304162|SUPERIORITY_OR_OTHER||LS means difference|3.61|||>|0.05|TWO_SIDED|95.0|-29.12|36.34|||Pair-wise comparisons|||Week 2, Treatment Effect||36.34|-29.12|>0.05
70907765|NCT00962585|141304162|SUPERIORITY_OR_OTHER||LS means difference|-4.58|||>|0.05|TWO_SIDED|95.0|-37.39|28.23|||Pair-wise comparisons|||Week 2, Treatment Effect||28.23|-37.39|>0.05
70907766|NCT00962585|141304162|SUPERIORITY_OR_OTHER||LS means difference|22.12|||>|0.05|TWO_SIDED|95.0|-23.56|67.8|||Pair-wise comparisons|||Week 4, Treatment Effect||67.80|-23.56|>0.05
70907767|NCT00962585|141304162|SUPERIORITY_OR_OTHER||LS means difference|7.8|||>|0.05|TWO_SIDED|95.0|-36.7|52.29|||Pair-wise comparisons|||Week 4, Treatment Effect||52.29|-36.70|>0.05
70907768|NCT00962585|141304162|SUPERIORITY_OR_OTHER||LS means difference|-22.74|||>|0.05|TWO_SIDED|95.0|-67.44|21.96|||Pair-wise comparisons|||Week 4, Treatment Effect||21.96|-67.44|>0.05
70907769|NCT00962585|141304166|SUPERIORITY_OR_OTHER|||||||0.0475||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4||||||0.0475
70907770|NCT00962585|141304166|SUPERIORITY_OR_OTHER|||||||0.0258||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4||||||0.0258
70907771|NCT00962585|141304166|SUPERIORITY_OR_OTHER|||||||0.0281||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4||||||0.0281
70907772|NCT00962585|141304166|SUPERIORITY_OR_OTHER|||||||0.0645||95.0|||||Kruskal-Wallis|||All three S-equol treatment arms were aggregated and compared to placebo.||||0.0645
70907773|NCT00962585|141304167|SUPERIORITY_OR_OTHER|||||||0.0097||||||P-value is adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol groups combined versus Placebo: Change from Baseline at Week 4||||||0.0097
70907774|NCT00962585|141304168|SUPERIORITY_OR_OTHER|||||||0.4352||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4||||||0.4352
70907775|NCT00962585|141304168|SUPERIORITY_OR_OTHER|||||||0.26||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4||||||0.2600
70907776|NCT00962585|141304168|SUPERIORITY_OR_OTHER|||||||0.7037||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4||||||0.7037
70907777|NCT00962585|141304168|SUPERIORITY_OR_OTHER|||||||0.7155|||||||Kruskal-Wallis|||All three S-equol treatment arms were aggregated and compared to placebo.||||0.7155
70907778|NCT00962585|141304169|SUPERIORITY_OR_OTHER|||||||0.0381||||||P-value is adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol groups combined versus Placebo: Change from Baseline at Week 4||||||0.0381
70907779|NCT00883103|141304170|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
70907780|NCT03954158|141304218|SUPERIORITY||Least squares mean of difference|-1.6|STANDARD_ERROR_OF_MEAN|0.53||0.0071|TWO_SIDED|95.0|-2.7|-0.5|||Mixed Models Analysis|||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures (MMRM) included the fixed effect of visit, and the covariance structure UN was used.||-0.5|-2.7|0.0071
70907781|NCT03954158|141304218|SUPERIORITY||Least squares mean of difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6||0.0029|TWO_SIDED|95.0|-3.3|-0.8|||Mixed Models Analysis|||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of visit, and the covariance structure UN was used.||-0.8|-3.3|0.0029
70907782|NCT03954158|141304218|SUPERIORITY||Least squares mean of difference|-1.5|STANDARD_ERROR_OF_MEAN|0.6||0.025|TWO_SIDED|95.0|-2.7|-0.2|||Mixed Models Analysis|||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of visit, and the covariance structure UN was used.||-0.2|-2.7|0.0250
70907783|NCT03954158|141304218|SUPERIORITY||Least squares mean of difference|-2.1|STANDARD_ERROR_OF_MEAN|0.56||0.0014|TWO_SIDED|95.0|-3.3|-0.9|||Mixed Models Analysis|||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of visit, and the covariance structure UN was used.||-0.9|-3.3|0.0014
70907784|NCT03954158|141304219|OTHER||Difference of least squares mean|-0.6|STANDARD_ERROR_OF_MEAN|0.4295|||TWO_SIDED|95.0|-2.0|0.9||||||Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||0.9|-2.0|
70907785|NCT03954158|141304219|OTHER||Difference of least squares mean|-0.8|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-2.1|0.4||||||Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||0.4|-2.1|
70907786|NCT03954158|141304220|OTHER||Least squares mean of difference|-1.9|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-3.1|-0.7||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.7|-3.1|
70907787|NCT03954158|141304220|OTHER||Least squares mean of difference|-1.4|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-2.7|-0.2||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.2|-2.7|
70907788|NCT03954158|141304220|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-2.2|-0.2||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.2|-2.2|
70907789|NCT03954158|141304220|OTHER||Least squares mean of difference|-1.7|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|95.0|-2.8|-0.5||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.5|-2.8|
70907790|NCT03954158|141304220|OTHER||Difference of least square mean|-0.1|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-1.5|1.3||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||1.3|-1.5|
71091975|NCT01126424|141690522|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.457||||0.867|TWO_SIDED|95.0|-18.976|16.062|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||16.062|-18.976|0.8670
70907791|NCT03954158|141304220|OTHER||Difference of least square mean|-0.1|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-1.2|1.0||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||1.0|-1.2|
70907792|NCT03954158|141304221|OTHER||Least squares mean of difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-0.9|-0.1||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.1|-0.9|
70907793|NCT03954158|141304221|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-0.9|0.0||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||0.0|-0.9|
70907794|NCT03954158|141304221|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|-0.8|0.1||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||0.1|-0.8|
70907795|NCT03954158|141304221|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.8|0.0||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||0.0|-0.8|
70907796|NCT03954158|141304221|OTHER||Difference of least square mean|0.1|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-0.4|0.6||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||0.6|-0.4|
70907797|NCT03954158|141304221|OTHER||Difference of least square mean|0.2|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.3|0.7||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||0.7|-0.3|
70907798|NCT03954158|141304221|OTHER||Least squares mean of difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-1.4|-0.4||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.4|-1.4|
70969836|NCT02411539|141445253|SUPERIORITY|Assuming that a common standard deviation of change (measured as difference of log10 transformed HIV-1 RNA/DNA ratios) in both arms was 0.30, with a sample size of 36 evaluable participants (18 in each arm), the study had 88% power to detect an effect size of 0.30 log10 (2-fold) in change of cell-associated HIV-1 RNA/DNA from baseline to week 6 using a two-sided Wilcoxon rank sum test at 10% type I error rate assuming a normal distribution||||||0.16||||||Two-sided Wilcoxon rank sum test at 10% significance level. Not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The primary efficacy analysis compared the change in cell-associated HIV-1 RNA/DNA ratio (log-transformed) from baseline to week 6 between the two randomized arms, testing the null hypothesis of no difference in changes in cell-associated HIV-1 RNA/DNA ratio between the two arms using a Wilcoxon rank sum test at 10% significance level.||||0.16
70969837|NCT01923129|141445300|NON_INFERIORITY|The primary outcome of interest was the rate of AUR, defined as the number of patients with AUR within each study group. A 15% non-inferiority margin was chosen according to clinical relevance estimation. The expected difference between the two groups was 0%. Non-inferiority analysis was performed by calculation of risk difference and its 95% confidence interval according to Newcombe \& Altman.|||||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
70969838|NCT03631732|141445301|NON_INFERIORITY|B/F/TAF is non-inferior to SBR if the upper bound of the 2-sided 95% confidence interval (CI) of the difference between treatment groups \[B/F/TAF - SBR\] in the percentage of participants with HIV-1 RNA ≥ 50 copies/mL is less than 6% (i.e., a margin of 6% is applied to non-inferiority assessment).|Difference in percentages|-1.2|||||TWO_SIDED|95.0|-4.8|0.9|||||Differences in percentages of participants with HIV-1 RNA \>= 50 copies/mL between treatment groups and 95% CI were calculated based on exact method.|||0.9|-4.8|
70969839|NCT03631732|141445301|SUPERIORITY|||||||0.3399|||||||Fisher Exact|||||||0.3399
70969840|NCT03631732|141445303|NON_INFERIORITY|B/F/TAF is non-inferior to SBR if the lower bound of the 2-sided 95% CI of the difference between treatment groups \[B/F/TAF - SBR\] in the percentage of participants with HIV-1 RNA \< 50 copies/mL is greater than -10% (i.e., a margin of 10% is applied to non-inferiority assessment).|Difference in percentages|1.8|||||TWO_SIDED|95.0|-2.0|6.8|||||Differences in percentages of participants with HIV-1 RNA \< 50 copies/mL between treatment groups and 95% CI were calculated based on exact method.|||6.8|-2.0|
70969841|NCT03631732|141445303|SUPERIORITY|||||||0.3532|||||||Fisher Exact|||||||0.3532
70969842|NCT03631732|141445304|NON_INFERIORITY|B/F/TAF is non-inferior to SBR if the lower bound of the 2-sided 95% CI of the difference between treatment groups \[B/F/TAF - SBR\] in the percentage of participants with HIV-1 RNA \< 50 copies/mL is greater than -10% (i.e., a margin of 10% is applied to non-inferiority assessment).|Difference in percentages|1.4|||||TWO_SIDED|95.0|-1.0|5.3|||||Differences in percentages of participants with HIV-1 RNA \< 50 copies/mL between treatment groups and 95% CI were calculated based on exact method.|||5.3|-1.0|
70969843|NCT03631732|141445304|SUPERIORITY|||||||0.3356|||||||Fisher Exact|||||||0.3356
70969844|NCT03631732|141445306|OTHER||Difference in LSM|11.0||||0.5618|TWO_SIDED|95.0|-27.0|49.0|||ANOVA|P-value was calculated from ANOVA model with treatment as a fixed effect.|Difference in LSM (Least square mean) and its 95% C.I. was calculated from ANOVA model with treatment as a fixed effect.|||49|-27|0.5618
70969845|NCT03631732|141445307|OTHER||Difference in LSM|9.0||||0.6632|TWO_SIDED|95.0|-31.0|48.0|||ANOVA|P-value was calculated from ANOVA model with treatment as a fixed effect.|Difference in LSM and its 95% C.I. was calculated from ANOVA model with treatment as a fixed effect.|||48|-31|0.6632
70907799|NCT03954158|141304221|OTHER||Least squares mean of difference|-0.7|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|95.0|-1.2|-0.2||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.2|-1.2|
70969846|NCT00768521|141445329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.18||||0.008||90.0|7.58|41.06||1-sided, alpha = 0.05|ANCOVA|Baseline used as covariate.|Primary Hypothesis: Tolterodine LA 4 mg is superior to placebo with respect to change from baseline in maximum cystometric capacity at 4 hours post Dose 7 (i.e., steady state). The expected treatment effect is targeted at 40 mL.|||41.06|7.58|0.008
70969847|NCT00768521|141445330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63||||0.422||90.0|-11.5|16.71||1-sided, alpha = 0.05|ANCOVA|Baseline used as covariate.||||16.71|-11.5|0.422
70969848|NCT02813551|141445372|SUPERIORITY||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.53|1.1||||||||1.10|0.53|
70969849|NCT02813551|141445373|SUPERIORITY||Risk Ratio (RR)|1.2|||||TWO_SIDED|95.0|0.4|3.3||||||||3.3|0.4|
70969850|NCT02813551|141445374|SUPERIORITY||Risk Ratio (RR)|3.0|||||TWO_SIDED|95.0|0.3|28.0||||||||28|0.3|
70969851|NCT02813551|141445375|SUPERIORITY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|1.0|1.3||||||||1.3|1.0|
71091976|NCT01126424|141690523|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-77.919||||0.5953|TWO_SIDED|95.0|-372.814|216.976|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||216.976|-372.814|0.5953
70969852|NCT02813551|141445378|SUPERIORITY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|1.0|1.2||||||||1.2|1.0|
70969853|NCT02813551|141445379|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.5|1.9||||||||1.9|0.5|
70969854|NCT02813551|141445380|SUPERIORITY||Risk Ratio (RR)|0.4|||||TWO_SIDED|95.0|0.1|2.9||||||||2.9|0.1|
70969855|NCT03070470|141445460|OTHER|The appropriateness of the linear model will be assessed. Projected estimates will be computed only if the linear model is found acceptable.|Mean Difference (Final Values)|1.2|||||TWO_SIDED|90.0|-9.5|12.0||The degrees of freedom for the model estimates were determined by the Kenward-Rogers method as prespecified in the SAP.|Mixed Models Analysis|||Upper bound of the 2-sided 90% confidence interval (CI) to be \<10 msec for the projected placebo-corrected change from baseline J-Tpeakc effect at the peak plasma level on Day 3 using a linear mixed-effects exposure response model||12.0|-9.5|
71008706|NCT02055976|141525244|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.004|STANDARD_ERROR_OF_MEAN|3.326||0.002|TWO_SIDED|95.0|3.395|16.612|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||16.612|3.395|0.002
70907800|NCT03954158|141304221|OTHER||Least squares mean of difference|-0.7|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|-1.2|-0.2||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.2|-1.2|
70907801|NCT03954158|141304221|OTHER||Least squares mean of difference|-1.0|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-1.4|-0.6||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.6|-1.4|
70907802|NCT03954158|141304221|OTHER||Difference of least square mean|0.0|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-0.5|0.6||||||Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||0.6|-0.5|
70907803|NCT03954158|141304221|OTHER||Difference of least square mean|-0.1|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|95.0|-0.7|0.5||||||Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||0.5|-0.7|
70907804|NCT03954158|141304222|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-1.0|-0.2||||||Change at Day 2, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.2|-1.0|
70969856|NCT03070470|141445460|OTHER|The appropriateness of the linear model will be assessed. Projected estimates will be computed only if the linear model is found acceptable.|Mean Difference (Final Values)|-2.6|||||TWO_SIDED|90.0|-11.4|6.1|||Mixed Models Analysis|The degrees of freedom for the model estimates were determined by the Kenward-Rogers method as prespecified in the SAP.||Upper bound of the 2-sided 90% confidence interval (CI) to be \<10 msec for the projected placebo-corrected change from baseline J-Tpeakc effect at the peak plasma level on Day 3 using a linear mixed-effects exposure response model||6.1|-11.4|
70969857|NCT03070470|141445460|OTHER|The appropriateness of the linear model will be assessed. Projected estimates will be computed only if the linear model is found acceptable.|Mean Difference (Final Values)|-2.9|||||TWO_SIDED|90.0|-14.6|8.8|||Mixed Models Analysis|The degrees of freedom for the model estimates were determined by the Kenward-Rogers method as prespecified in the SAP.||Upper bound of the 2-sided 90% confidence interval (CI) to be \<10 msec for the projected placebo-corrected change from baseline J-Tpeakc effect at the peak plasma level on Day 3 using a linear mixed-effects exposure response model||8.8|-14.6|
70969858|NCT03070470|141445461|OTHER|The appropriateness of the linear model will be assessed. Projected estimates will be computed only if the linear model is found acceptable.|Mean Difference (Final Values)|30.7|||||TWO_SIDED|90.0|22.6|38.9|||Mixed Models Analysis|The degrees of freedom for the model estimates were determined by the Kenward-Rogers method as prespecified in the SAP.||Upper bound of the 2-sided 90% CI to be ≥10 msec for the projected placebo-corrected change from baseline QTc effect at the peak plasma level on Day 1 using a linear mixed-effects exposure response model.||38.9|22.6|
70969859|NCT01757678|141445463|OTHER||Difference in Probability|0.14|||||TWO_SIDED|95.0|0.09|0.19||||||||.19|.09|
70907805|NCT03954158|141304222|OTHER||Least squares mean of difference|-0.1|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|95.0|-0.7|0.5||||||Change at Day 2, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.5|-0.7|
70907806|NCT03954158|141304222|OTHER||Difference of least squares mean|0.6|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-0.5|1.7||||||Change at Day 2, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.7|-0.5|
70907807|NCT03954158|141304222|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-1.3|0.1||||||Change at Day 3, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.1|-1.3|
70969860|NCT01757678|141445464|OTHER||Difference in Probability|0.09|||||TWO_SIDED|95.0|0.04|0.14||||||||.14|.04|
70907808|NCT03954158|141304222|OTHER||Least squares mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-0.9|0.4||||||Change at Day 3, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.4|-0.9|
70907809|NCT03954158|141304222|OTHER||Difference of least square mean|0.2|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|95.0|-0.9|1.3||||||Change at Day 3, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.3|-0.9|
70969861|NCT01500278|141445470|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||=|0.467|TWO_SIDED|95.0|0.67|1.2||The odds ratio, CI, and p-value are from a logistic regression model with RTG, gender, Baseline duration of RA (\<2 years or \>=2 years), and geographic region as factors and age as a covariate.|Regression, Logistic|||||1.20|0.67|=0.467
71030626|NCT01029353|141569491|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.66|1.06|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.06|0.66|
70907810|NCT03954158|141304222|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-2.1|-0.5||||||Change at Day 4, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.5|-2.1|
70907811|NCT03954158|141304222|OTHER||Least squares mean of difference|-0.8|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-1.5|-0.1||||||Change at Day 4, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.1|-1.5|
70969862|NCT01500278|141445471|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09|||=|0.532|TWO_SIDED|95.0|0.82|1.45||The odds ratio, CI and p-value are from a logistic regression model with RTG, gender, Baseline duration of RA (\<2 years or \>=2 years), and geographic region as factors and Baseline DAS28(ESR) and age as covariates.|Regression, Logistic|||||1.45|0.82|=0.532
70969863|NCT02459795|141445479|EQUIVALENCE|provides 85% power of success|Equivalence ratio|1.0|||||TWO_SIDED|90.0|-7.0|12.92|||Yates correction|||||12.92|-7.00|
70969864|NCT01297270|141445509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.7|||<|0.0001|TWO_SIDED|95.0|10.7|30.6|||Cochran-Mantel-Haenszel||Estimate adjusted for genotype and race using Koch's method, with continuity correction|||30.6|10.7|<0.0001
70907812|NCT03954158|141304222|OTHER||Difference of least square mean|0.4|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-0.6|1.4||||||Change at Day 4, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.4|-0.6|
70907813|NCT03954158|141304222|OTHER||Least squares mean of difference|-1.1|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-1.9|-0.3||||||Change at Day 5, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.3|-1.9|
70907814|NCT03954158|141304222|OTHER||Least squares mean of difference|-0.8|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-1.5|-0.1||||||Change at Day 5, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.1|-1.5|
70907815|NCT03954158|141304222|OTHER||Difference of least square mean|-0.1|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-1.1|1.0||||||Change at Day 5, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.0|-1.1|
70907816|NCT03954158|141304222|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-2.1|-0.4||||||Change at Day 6, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.4|-2.1|
70907817|NCT03954158|141304222|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|95.0|-1.1|0.4||||||Change at Day 6, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.4|-1.1|
70907818|NCT03954158|141304222|OTHER||Difference of least square mean|0.5|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|95.0|-0.6|1.5||||||Change at Day 6, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.5|-0.6|
70907819|NCT03954158|141304222|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-2.3|-0.1||||||Change at Day 7, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.1|-2.3|
70907820|NCT03954158|141304222|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|95.0|-1.0|0.2||||||Change at Day 7, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.2|-1.0|
70907821|NCT03954158|141304222|OTHER||Difference of least square mean|0.3|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-0.6|1.3||||||Change at Day 7, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.3|-0.6|
70907822|NCT03954158|141304222|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-2.0|-0.3||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.3|-2.0|
70907823|NCT03954158|141304222|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-1.3|0.1||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.1|-1.3|
70907824|NCT03954158|141304222|OTHER||Difference of least square mean|0.3|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-0.6|1.2||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.2|-0.6|
70907825|NCT03954158|141304222|OTHER||Least squares mean of difference|-1.7|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-2.4|-0.9||||||Change at Day 9, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.9|-2.4|
70907826|NCT03954158|141304222|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-1.5|0.7||||||Change at Day 9, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.7|-1.5|
70907827|NCT03954158|141304222|OTHER||Difference of least square mean|0.5|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|95.0|-0.7|1.6||||||Change at Day 9, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.6|-0.7|
70907828|NCT03954158|141304222|OTHER||Least squares mean of difference|-1.6|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-2.3|-0.9||||||Change at Day 10, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.9|-2.3|
70907829|NCT03954158|141304222|OTHER||Least squares mean of difference|-1.1|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-2.1|-0.1||||||Change at Day 10, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.1|-2.1|
70907830|NCT03954158|141304222|OTHER||Difference of Least Squares Mean|0.2|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-0.8|1.2||||||Change at Day 10, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.||1.2|-0.8|
70907831|NCT03954158|141304222|OTHER||Least squares mean of difference|-0.9|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.7|0.0||||||Change at Day 11, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.0|-1.7|
70907832|NCT03954158|141304222|OTHER||Least squares mean of difference|-1.5|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-2.3|-0.7||||||Change at Day 11, Intra-participant: MMRM included the fixed effect of day, and the covariance structure UN was used.||-0.7|-2.3|
70907833|NCT03954158|141304222|OTHER||Difference of Least Squares Mean|0.2|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-0.7|1.1||||||Change at Day 11, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.||1.1|-0.7|
70907834|NCT03954158|141304222|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-2.0|-0.5||||||Change at Day 12, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.5|-2.0|
70969865|NCT01297270|141445509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.4||||0.0007|TWO_SIDED|95.0|7.3|27.4|||Cochran-Mantel-Haenszel||Estimate adjusted for genotype and race using Koch's method, with continuity correction|||27.4|7.3|0.0007
70969866|NCT01297270|141445510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.7|||<|0.0001|TWO_SIDED|95.0|10.7|30.6|||Cochran-Mantel-Haenszel||Estimate adjusted for genotype and race using Koch's method, with continuity correction|||30.6|10.7|<0.0001
70969867|NCT01297270|141445510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.6||||0.0014|TWO_SIDED|95.0|6.5|26.7|||Cochran-Mantel-Haenszel||Estimate adjusted for genotype and race using Koch's method, with continuity correction|||26.7|6.5|0.0014
70969868|NCT01765920|141445532|SUPERIORITY|||||||0.0174||||||A priori threshold for statistical significance α=0.0221 (Pocock boundary for 3 interim analyses).|Kruskal-Wallis|||||||0.0174
70969869|NCT01765920|141445533|SUPERIORITY|||||||0.0719||||||A priori threshold for statistical significance α=0.0221 (Pocock boundary for 3 interim analyses).|Kruskal-Wallis|||||||0.0719
70969870|NCT01765920|141445534|SUPERIORITY|||||||0.02||||||Total score analysis. A priori threshold for statistical significance α=0.0221 (Pocock boundary for 3 interim analyses).|Kruskal-Wallis|||||||0.02
70969871|NCT01765920|141445534|SUPERIORITY|||||||0.0099||||||"Symptoms domain analysis. A priori threshold for statistical significance α=0.0221 (Pocock boundary for 3 interim analyses)."|Kruskal-Wallis|||||||0.0099
70969872|NCT01765920|141445534|SUPERIORITY|||||||0.037||||||"Ability domain analysis. A priori threshold for statistical significance α=0.0221 (Pocock boundary for 3 interim analyses)."|Kruskal-Wallis|||||||0.037
70969873|NCT01765920|141445535|SUPERIORITY|||||||0.22||||||Day 1 analysis.|Fisher Exact|||||||0.22
70969874|NCT01765920|141445535|SUPERIORITY|||||||0.32||||||Day 2 analysis.|Fisher Exact|||||||0.32
70969875|NCT01765920|141445535|SUPERIORITY|||||||0.47||||||Day 3 analysis.|Fisher Exact|||||||0.47
70907835|NCT03954158|141304222|OTHER||Least squares mean of difference|-1.0|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-2.0|0.0||||||Change at Day 12, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.0|-2.0|
70969876|NCT01765920|141445535|SUPERIORITY|||||||0.72||||||Day 4 analysis.|Fisher Exact|||||||0.72
70969877|NCT01765920|141445535|SUPERIORITY|||||||0.25||||||Day 5 analysis.|Fisher Exact|||||||0.25
70969878|NCT01765920|141445536|SUPERIORITY|||||||0.68|||||||Fisher Exact|||||||0.68
70969879|NCT04474795|141445544|SUPERIORITY||||||<|0.0001|||||||Wilcoxon paired signed rank test|||Compared pre and post training scores||||<0.0001
70969880|NCT04474795|141445545|SUPERIORITY||||||<|0.0001|||||||Wilcoxon paired signed rank test|||Comparison of scores pre and post training in individuals who completed training modules||||<0.0001
70969881|NCT04474795|141445546|SUPERIORITY|||||||0.606|||||||Wilcoxon paired signed rank test|||Patient autonomy||||0.606
70907836|NCT03954158|141304222|OTHER||Difference of Least Squares Mean|0.1|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-0.9|1.2||||||Change at Day 12, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.||1.2|-0.9|
70969882|NCT04474795|141445546|SUPERIORITY|||||||0.003|||||||Wilcoxon paired signed rank test|||Value of tight control||||0.003
70969883|NCT04474795|141445546|SUPERIORITY|||||||0.475|||||||Wilcoxon paired signed rank test|||Need for Special Training||||0.475
70969884|NCT04474795|141445547|SUPERIORITY|||||||0.009|||||||Wilcoxon paired signed rank test|||||||0.009
70969885|NCT04041284|141445550|OTHER||LS mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|-3.16|-1.21|||ANCOVA|||||-1.21|-3.16|<0.0001
70969886|NCT04041284|141445551|OTHER||LS mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.61||0.0205|TWO_SIDED|95.0|-2.61|-0.22|||Mixed Models Analysis|||||-0.22|-2.61|0.0205
70969887|NCT04041284|141445552|OTHER||Odds Ratio (OR)|3.26|||<|0.0001|TWO_SIDED|95.0|1.89|5.62|||Regression, Logistic|||||5.62|1.89|<0.0001
70969888|NCT04041284|141445553|OTHER||LS mean difference|11.3|STANDARD_ERROR_OF_MEAN|2.21|<|0.0001|TWO_SIDED|95.0|6.91|15.59|||Mixed Models Analysis||Restrictive score: Fremanezumab versus placebo|||15.59|6.91|<0.0001
70969889|NCT04041284|141445553|OTHER||LS mean difference|9.9|STANDARD_ERROR_OF_MEAN|2.12|<|0.0001|TWO_SIDED|95.0|5.73|14.08|||Mixed Models Analysis||Preventive score: Fremanezumab versus placebo|||14.08|5.73|<0.0001
70969890|NCT04041284|141445554|OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0915|TWO_SIDED|95.0|-0.39|0.03|||Mixed Models Analysis||Change at Week 4: Fremanezumab versus Placebo|||0.03|-0.39|0.0915
70969891|NCT04041284|141445554|OTHER||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.11||0.0006|TWO_SIDED|95.0|-0.59|-0.16|||Mixed Models Analysis||Change at Week 8: Fremanezumab versus Placebo|||-0.16|-0.59|0.0006
70969892|NCT04041284|141445554|OTHER||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.12||0.003|TWO_SIDED|95.0|-0.58|-0.12|||Mixed Models Analysis||Change at Week 12: Fremanezumab versus Placebo|||-0.12|-0.58|0.0030
70969893|NCT04041284|141445555|OTHER||LS mean difference|-3.6|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-5.15|-1.96|||Mixed Models Analysis|||||-1.96|-5.15|<0.0001
70969894|NCT00563186|141445564|SUPERIORITY_OR_OTHER|This statistical analysis applies to the overall VRE, CDI and MRSA infection and colonization events expressed as incidence density (per 1000 patient-days at risk).|Incidence Rate ratio|1.6|STANDARD_ERROR_OF_MEAN|0.57||0.18|TWO_SIDED|95.0|0.8|3.22|||Poisson||Numerator is novel ward and denominator is traditional ward.|"It was calculated that this study will require 9750 patient days of observation in the traditional design wards and 19,500 patient days of observation in the novel design ward to ensure 80% statistical power to detect a 60% difference in the rates of incident cases of selected HAIs and ARO colonizations (the primary outcome measure) with an α level of 0.05 assuming that incident cases in each unit follow Poisson distribution based on well established historic trends on these units"||3.22|0.80|0.18
70969895|NCT00563186|141445566|SUPERIORITY_OR_OTHER||Rate Ratio|1.929|STANDARD_ERROR_OF_MEAN|0.493||0.175|TWO_SIDED|95.0|0.76|4.9|||Large test for person-time analysis|||||4.9|0.76|0.175
70969896|NCT01087905|141445567|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.076|TWO_SIDED|95.0|0.98|1.61|||Regression, Logistic|||"Null hypothesis: No difference in abstinence rates for participants receiving Two Weeks of Nicotine Replacement Therapy (NRT) versus Six Weeks of Nicotine Replacement Therapy (NRT). We hypothesized that Six Weeks of NRT would result in statistically significantly higher abstinence rates compared to Two Weeks of NRT.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention (e.g., 6 wks NRT)."||1.61|0.98|.076
70907837|NCT03954158|141304222|OTHER||Least squares mean of difference|-1.1|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-1.8|-0.3||||||Change at Day 13, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.3|-1.8|
70907838|NCT03954158|141304222|OTHER||Least squares mean of difference|-1.0|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-2.0|-0.1||||||Change at Day 13, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.1|-2.0|
70907839|NCT03954158|141304222|OTHER||Difference of Least Squares Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-1.3|0.9||||||Change at Day 13, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.||0.9|-1.3|
70907840|NCT03954158|141304222|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-1.9|-0.5||||||Change at Day 14, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.5|-1.9|
70907841|NCT03954158|141304222|OTHER||Least squares mean of difference|-1.0|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.8|-0.1||||||Change at Day 14, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.1|-1.8|
70907842|NCT03954158|141304222|OTHER||Difference of Least Squares Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-1.5|0.7||||||Change at Day 14, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.||0.7|-1.5|
70907843|NCT03954158|141304222|OTHER||Least squares mean of difference|-1.5|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-2.2|-0.8||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.8|-2.2|
70907844|NCT03954158|141304222|OTHER||Least squares mean of difference|-0.8|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-1.5|0.0||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||0.0|-1.5|
70907845|NCT03954158|141304222|OTHER||Difference of least square mean|-0.3|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-1.4|0.8||||||Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||0.8|-1.4|
70907846|NCT03954158|141304223|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-1.0|0.2||||||Change at Day 2, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.2|-1.0|
70907847|NCT03954158|141304223|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.1|0.5||||||Change at Day 2, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.5|-1.1|
70907848|NCT03954158|141304223|OTHER||Difference of least squares mean|0.3|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-0.5|1.1||||||Change at Day 2, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||1.1|-0.5|
70907849|NCT03954158|141304223|OTHER||Least squares mean of difference|0.1|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.6|0.7||||||Change at Day 3, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.7|-0.6|
70907850|NCT03954158|141304223|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.5|0.2||||||Change at Day 3, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.2|-1.5|
70907851|NCT03954158|141304223|OTHER||Difference of least squares mean|-0.2|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-1.0|0.5||||||Change at Day 3, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.5|-1.0|
70907852|NCT03954158|141304223|OTHER||Least squares mean of difference|0.0|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|96.0|-1.1|1.1||||||Change at Day 4, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||1.1|-1.1|
70907853|NCT03954158|141304223|OTHER||Least squares mean of difference|0.0|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-0.8|0.8||||||Change at Day 4, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.8|-0.8|
70907854|NCT03954158|141304223|OTHER||Difference of least squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|95.0|-0.9|0.8||||||Change at Day 4, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.8|-0.9|
70907855|NCT03954158|141304223|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-1.2|0.3||||||Change at Day 5, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.3|-1.2|
70907856|NCT03954158|141304223|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.2|0.4||||||Change at Day 5, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.4|-1.2|
70907857|NCT03954158|141304223|OTHER||Difference of least squares mean|0.1|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-0.8|1.0||||||Change at Day 5, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||1.0|-0.8|
70907858|NCT03954158|141304223|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.2|0.6||||||Change at Day 6, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.6|-1.2|
70907859|NCT03954158|141304223|OTHER||Least squares mean of difference|-0.1|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-0.9|0.7||||||Change at Day 6, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.7|-0.9|
70969897|NCT01087905|141445567|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.017|TWO_SIDED|95.0|1.06|1.75|||Regression, Logistic|||"Null hypothesis: No difference in abstinence rates for participants receiving NRT Monotherapy (Nicotine Patch Only) versus NRT Combination Therapy (Nicotine Patch plus Nicotine Gum). We hypothesized that Combination NRT would result in statistically significantly higher abstinence rates compared to NRT Monotherapy.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention (e.g., Combination NRT)."||1.75|1.06|.017
70969898|NCT01087905|141445567|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.343|TWO_SIDED|95.0|0.69|1.14|||Regression, Logistic|||"Null hypothesis: No difference in abstinence rates for participants receiving Standard Cessation Counseling (No CMAC) versus Standard Cessation Counseling plus CMAC. We hypothesized that Standard Counseling plus CMAC would result in statistically significantly higher abstinence rates compared to Standard Counseling Only.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention (e.g., Standard Counseling plus CMAC)."||1.14|0.69|.343
70969899|NCT01087905|141445568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.029|TWO_SIDED|95.0|1.04|2.14|||Regression, Logistic||Inclusion of the Cognitive Medication Adherence Counseling (CMAC) factor (No CMAC versus CMAC) as a control variable did not change the results of this analysis.|"Null hypothesis: No difference in abstinence rates for participants receiving Two Weeks of Nicotine Replacement Therapy (NRT) Monotherapy (Nicotine Patch Only) versus Two Weeks of Combination NRT (Patch+Gum). We hypothesized that Two Weeks of Combination NRT would result in statistically significantly higher abstinence rates compared to Two Weeks of NRT Monotherapy.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention."||2.14|1.04|.029
70969900|NCT01087905|141445568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.079|TWO_SIDED|95.0|0.96|1.97|||Regression, Logistic||Inclusion of the Cognitive Medication Adherence Counseling (CMAC) factor (No CMAC versus CMAC) as a control variable did not change the results of this analysis.|"Null hypothesis: No difference in abstinence rates for participants receiving Two Weeks of Nicotine Replacement Therapy (NRT) Monotherapy (Nicotine Patch Only) versus SIx Weeks of NRT Monotherapy. We hypothesized that Six Weeks of NRT Monotherapy would result in statistically significantly higher abstinence rates compared to Two Weeks of NRT Monotherapy.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention."||1.97|0.96|.079
70969901|NCT01087905|141445568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.003|TWO_SIDED|95.0|1.2|2.45|||Regression, Logistic||Inclusion of the Cognitive Medication Adherence Counseling (CMAC) factor (No CMAC versus CMAC) as a control variable did not change the results of this analysis.|"Null hypothesis: No difference in abstinence rates for participants receiving Two Weeks of Nicotine Replacement Therapy (NRT) Monotherapy (Nicotine Patch Only) versus Six Weeks of Combination NRT (Patch+Gum). We hypothesized that Six Weeks of Combination NRT would result in statistically significantly higher abstinence rates compared to Two Weeks of NRT Monotherapy.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention."||2.45|1.20|.003
70969902|NCT01087905|141445569|SUPERIORITY_OR_OTHER||incremental cost-effectiveness ratio|357.0||||||95.0||||There is no p-value for the incremental cost-effectiveness ratio (ICER).|Incremental cost-effectiveness ratio|Unit of measurement for ICER is U.S. dollars.||In this analysis, the incremental cost-effectiveness ratio (ICER) is computed. ICER is a measure of the added cost per added quit for two treatments. ICER was computed as the cost difference between the least intensive treatment group (2 weeks of nicotine patch only) and a more intensive comparison group divided by the difference in the quit rates of the two groups being compared; ICER for the group that received 2 weeks of nicotine patch and nicotine gum = (213-178)/(.482-.384) = $357.||||
70969903|NCT01087905|141445569|SUPERIORITY_OR_OTHER||Incremental cost-effectiveness ratio|712.0||||||95.0||||There is no p-value for the incremental cost-effectiveness ratio (ICER).|Incremental cost-effectiveness ratio|Unit of measurement for ICER is U.S. dollars.||In this analysis, the incremental cost-effectiveness ratio (ICER) is computed. ICER is a measure of the added cost per added quit for two treatments. ICER was computed as the cost difference between the least intensive treatment group (2 weeks of nicotine patch only) and a more intensive comparison group divided by the difference in the quit rates of the two groups being compared; ICER for the group that received 6 weeks of nicotine patch only = (233-178)/(.462-.384) = $712.||||
70969904|NCT01087905|141445569|SUPERIORITY_OR_OTHER||Incremental cost-effectiveness ratio|1290.0||||||95.0||||There is no p-value for the incremental cost-effectiveness ratio (ICER).|Incremental cost-effectiveness ratio|Unit of measurement for ICER is U.S. dollars.||In this analysis, the Incremental cost-effectiveness ratio (ICER) is computed. ICER is a measure of the added cost per added quit for two treatments. ICER was computed as the cost difference between the least intensive treatment group (2 weeks of nicotine patch only) and a more intensive comparison group divided by the difference in the quit rates of the two groups being compared; ICER for the group that received 6 weeks of nicotine patch and nicotine gum = (348-178)/(.516-.384) = $1290.||||
70969905|NCT00135668|141445646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.2|STANDARD_DEVIATION|16.16|<|0.001|TWO_SIDED|95.0|-18.44|-13.97|||t-test, 2 sided|Paired t-test used.||Paired t-test used to test the null hypothesis of no change in MAP from baseline.||-13.97|-18.44|<0.001
70969906|NCT00135668|141445646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.0|STANDARD_DEVIATION|15.68|<|0.001|TWO_SIDED|95.0|-15.45|-6.55|||t-test, 2 sided|Paired t-test.||||-6.55|-15.45|<0.001
71091977|NCT01126424|141690523|SUPERIORITY_OR_OTHER||Least Square Mean Difference|157.783||||0.3526|TWO_SIDED|95.0|-182.015|497.581|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||497.581|-182.015|0.3526
71153594|NCT00243269|141799591|SUPERIORITY_OR_OTHER|||||||0.932||95.0|||||ANOVA|||The primary analyses consisted of calculating means and standard deviations on nausea for the four study arms to generate an effect size estimate for a later R01. We also planned to use a 2 x 2 (i.e., two levels of expectancy CDs and two levels of expectancy handouts) full factorial analysis of variance (ANOVA) to examine the efficacy of these two methods of expectancy enhancement in reducing Average Nausea as well as any interaction effects.||||0.932
71153595|NCT00243269|141799592|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||ANOVA|||ANOVA to compare means of the four groups was used.||||0.84
70907860|NCT03954158|141304223|OTHER||Difference of least squares mean|0.1|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|95.0|-0.5|0.8||||||Change at Day 6, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.8|-0.5|
70907861|NCT03954158|141304223|OTHER||Least squares mean of difference|-0.1|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|95.0|-1.0|0.9||||||Change at Day 7, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.9|-1.0|
70907862|NCT03954158|141304223|OTHER||Least squares mean of difference|-0.1|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.0|0.7||||||Change at Day 7, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.7|-1.0|
70907863|NCT03954158|141304223|OTHER||Difference of least squares mean|-0.4|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.2|0.5||||||Change at Day 7, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.5|-1.2|
70907864|NCT03954158|141304223|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.3|0.5||||||Change at Day 8, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.5|-1.3|
70907865|NCT03954158|141304223|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.4|0.2||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.2|-1.4|
70907866|NCT03954158|141304223|OTHER||Difference of least squares mean|0.2|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-0.5|0.8||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.8|-0.5|
70907867|NCT03954158|141304223|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-1.2|0.6||||||Change at Day 9, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.6|-1.2|
70907868|NCT03954158|141304223|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.2|0.4||||||Change at Day 9, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.4|-1.2|
70907869|NCT03954158|141304223|OTHER||Difference of least squares mean|-0.6|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|95.0|-1.2|0.1||||||Change at Day 9, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.1|-1.2|
70907870|NCT03954158|141304223|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-1.3|0.7||||||Change at Day 10, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.7|-1.3|
70907871|NCT03954158|141304223|OTHER||Least squares mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.0|0.6||||||Change at Day 10, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.6|-1.0|
70907872|NCT03954158|141304223|OTHER||Difference of least squares mean|-0.1|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-0.8|0.5||||||Change at Day 10, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.5|-0.8|
70907873|NCT03954158|141304223|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-1.6|0.3||||||Change at Day 11, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.3|-1.6|
70907874|NCT03954158|141304223|OTHER||Difference of least squares mean|0.3|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-0.4|1.0||||||Change at Day 11, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||1.0|-0.4|
70907875|NCT03954158|141304223|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.2|0.5||||||Change at Day 11, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.5|-1.2|
70907876|NCT03954158|141304223|OTHER||Least squares mean of difference|-0.9|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|95.0|-1.9|0.0||||||Change at Day 12, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.0|-1.9|
70907877|NCT03954158|141304223|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.5|0.2||||||Change at Day 12, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.2|-1.5|
70907878|NCT03954158|141304223|OTHER||Difference of least squares mean|-0.3|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|95.0|-1.0|0.5||||||Change at Day 12, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.5|-1.0|
70907879|NCT03954158|141304223|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-1.5|0.4||||||Change at Day 13, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.4|-1.5|
70907880|NCT03954158|141304223|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.5|0.2||||||Change at Day 13, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.2|-1.5|
70907881|NCT03954158|141304223|OTHER||Least squares mean|-0.4|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-1.1|0.3||||||Change at Day 13, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.3|-1.1|
70907882|NCT03954158|141304223|OTHER||Least squares mean of difference|-0.5|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.4|0.4||||||Change at Day 14, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.4|-1.4|
70907883|NCT03954158|141304223|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.1|0.5||||||Change at Day 14, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.5|-1.1|
70969907|NCT00135668|141445646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.0|STANDARD_DEVIATION|12.88|<|0.001|TWO_SIDED|95.0|-20.7|-13.3|||t-test, 2 sided|Paired t-test.||||-13.30|-20.70|<0.001
70969908|NCT00135668|141445646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.0|STANDARD_DEVIATION|15.95|<|0.001|TWO_SIDED|95.0|-24.38|-15.58|||t-test, 2 sided|Paired t-test.||||-15.58|-24.38|<0.001
70969909|NCT00135668|141445646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.6|STANDARD_DEVIATION|18.63|<|0.001|TWO_SIDED|95.0|-21.87|-11.39|||t-test, 2 sided|Paired t-test||||-11.39|-21.87|<0.001
70969910|NCT02873936|141445696|SUPERIORITY||Difference in Response Rates|34.9|||<|0.001|TWO_SIDED|95.0|23.5|46.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||46.3|23.5|<0.001
70969911|NCT02873936|141445696|SUPERIORITY||Difference in Response Rates|26.4|||<|0.001|TWO_SIDED|95.0|15.0|37.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||37.9|15.0|<0.001
70969912|NCT02873936|141445697|SUPERIORITY||Least Squares Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.066|<|0.001|TWO_SIDED|95.0|-0.45|-0.19||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. Least squares (LS)-Mean, 95% confidence interval (CI), and P-value were provided from mixed effects model for repeated measure (MMRM). Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.19|-0.45|<0.001
70969913|NCT02873936|141445697|SUPERIORITY||Least Squares Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.065|<|0.001|TWO_SIDED|95.0|-0.4|-0.14||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.14|-0.40|<0.001
70969914|NCT02873936|141445698|SUPERIORITY||Difference in Response Rates|25.3|||<|0.001|TWO_SIDED|95.0|14.7|35.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||35.8|14.7|<0.001
70907884|NCT03954158|141304223|OTHER||Difference of least squares mean|-0.2|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-1.0|0.6||||||Change at Day 14, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.6|-1.0|
70969915|NCT02873936|141445698|SUPERIORITY||Difference in Response Rates|21.7|||<|0.001|TWO_SIDED|95.0|11.4|32.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||32.0|11.4|<0.001
70969916|NCT02873936|141445699|SUPERIORITY||Least Squares Mean Difference|4.3|STANDARD_ERROR_OF_MEAN|0.92|<|0.001|TWO_SIDED|95.0|2.5|6.1||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||6.1|2.5|<0.001
70969917|NCT02873936|141445699|SUPERIORITY||Least Squares Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|0.92|<|0.001|TWO_SIDED|95.0|1.6|5.2||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.2|1.6|<0.001
70969918|NCT02873936|141445700|SUPERIORITY||Difference in Response Rates|18.5|||<|0.001|TWO_SIDED|95.0|8.6|28.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||28.3|8.6|<0.001
70969919|NCT02873936|141445700|SUPERIORITY||Difference in Response Rates|14.0||||0.003|TWO_SIDED|95.0|4.6|23.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||23.4|4.6|0.003
70969920|NCT02873936|141445701|SUPERIORITY||Least Squares Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|1.19|<|0.001|TWO_SIDED|95.0|2.6|7.3||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||7.3|2.6|<0.001
70907885|NCT03954158|141304223|OTHER||Least squares mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-0.9|0.5||||||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.5|-0.9|
71091978|NCT01134042|141690532|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.193|||<|0.001|TWO_SIDED|95.0|0.108|0.277|||ANCOVA|||||0.277|0.108|<0.001
71091979|NCT01134042|141690532|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.21|||<|0.001|TWO_SIDED|95.0|0.127|0.294|||ANCOVA|||||0.294|0.127|<0.001
70907886|NCT03954158|141304223|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.2|0.5||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.5|-1.2|
70907887|NCT03954158|141304223|OTHER||Difference of least squares mean|-0.2|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-1.0|0.6||||||Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.6|-1.0|
71091980|NCT01134042|141690532|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the confidence interval (CI: 0.025, 1-sided significance level) for the mean difference in change from Baseline in clinic visit trough FEV1 of FF 200 µg OD versus FP 500 µg BID was greater than -125 milliliters.|Median Difference (Final Values)|0.018|||||TWO_SIDED|95.0|-0.066|0.102||||||||0.102|-0.066|
70907888|NCT03954158|141304224|OTHER||Least squares mean of difference|-0.1|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-0.9|0.7||||||Change at Day 2, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.7|-0.9|
70907889|NCT03954158|141304224|OTHER||Least squares mean of difference|0.2|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-0.6|1.0||||||Change at Day 2, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||1.0|-0.6|
70907890|NCT03954158|141304224|OTHER||Difference of least squares mean|0.2|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-0.8|1.2||||||Change at Day 2, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||1.2|-0.8|
70907891|NCT03954158|141304224|OTHER||Least squares mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|95.0|-0.9|0.5||||||Change at Day 3, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.5|-0.9|
70907892|NCT03954158|141304224|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.58|||TWO_SIDED|95.0|-1.5|1.0||||||Change at Day 3, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||1.0|-1.5|
70907893|NCT03954158|141304224|OTHER||Difference of least squares mean|-0.6|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-1.6|0.5||||||Change at Day 3, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.5|-1.6|
70907894|NCT03954158|141304224|OTHER||Least squares mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-1.1|0.8||||||Change at Day 4, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.8|-1.1|
70907895|NCT03954158|141304224|OTHER||Least squares mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-1.5|1.1||||||Change at Day 4, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||1.1|-1.5|
70907896|NCT03954158|141304224|OTHER||Difference of least squares mean|-0.9|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|95.0|-2.4|0.6||||||Change at Day 4, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.6|-2.4|
70907897|NCT03954158|141304224|OTHER||Least squares mean of difference|-1.4|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-2.2|-0.5||||||Change at Day 5, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.5|-2.2|
70907898|NCT03954158|141304224|OTHER||Least squares mean of difference|0.1|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-1.3|1.5||||||Change at Day 5, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||1.5|-1.3|
70907899|NCT03954158|141304224|OTHER||Difference of least squares mean|-0.2|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-1.7|1.2||||||Change at Day 5, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||1.2|-1.7|
70907900|NCT03954158|141304224|OTHER||Least squares mean of difference|-1.0|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-2.0|0.0||||||Change at Day 6, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.0|-2.0|
70907901|NCT03954158|141304224|OTHER||Least squares mean of difference|-0.5|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-1.4|0.5||||||Change at Day 6, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.5|-1.4|
70907902|NCT03954158|141304224|OTHER||Difference of least squares mean|-0.4|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-1.7|0.8||||||Change at Day 6, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.8|-1.7|
70907903|NCT03954158|141304224|OTHER||Least squares mean of difference|-1.1|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-2.0|-0.2||||||Change at Day 7, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.2|-2.0|
70907904|NCT03954158|141304224|OTHER||Least squares mean of difference|-1.1|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|95.0|-2.1|-0.1||||||Change at Day 7, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.1|-2.1|
70907905|NCT03954158|141304224|OTHER||Difference of least squares mean|-0.6|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-1.9|0.6||||||Change at Day 7, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.6|-1.9|
70907906|NCT03954158|141304224|OTHER||Least squares mean of difference|-1.0|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-2.0|0.0||||||Change at Day 8, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.0|-2.0|
70907907|NCT03954158|141304224|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-2.4|-0.2||||||Change at Day 8, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.2|-2.4|
71091981|NCT01134042|141690533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136||||0.048|TWO_SIDED|95.0|0.001|0.27|||ANCOVA|||||0.270|0.001|0.048
71091982|NCT01134042|141690533|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.206||||0.003|TWO_SIDED|95.0|0.073|0.339|||ANCOVA|||||0.339|0.073|0.003
70907908|NCT03954158|141304224|OTHER||Difference of least squares mean|-0.6|STANDARD_ERROR_OF_MEAN|0.64|||TWO_SIDED|95.0|-1.9|0.7||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.7|-1.9|
70907909|NCT03954158|141304224|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-2.3|-0.1||||||Change at Day 9, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.1|-2.3|
70907910|NCT03954158|141304224|OTHER||Least squares mean of difference|-0.9|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-1.9|0.1||||||Change at Day 9, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.1|-1.9|
70907911|NCT03954158|141304224|OTHER||Difference of least squares mean|-1.1|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-2.4|0.2||||||Change at Day 9, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.2|-2.4|
70907912|NCT03954158|141304224|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-2.4|-0.1||||||Change at Day 10, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.1|-2.4|
70907913|NCT03954158|141304224|OTHER||Least squares mean of difference|-1.6|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-2.5|-0.7||||||Change at Day 10, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.7|-2.5|
70907914|NCT03954158|141304224|OTHER||Difference of least squares mean|-1.4|STANDARD_ERROR_OF_MEAN|0.58|||TWO_SIDED|95.0|-2.6|-0.2||||||Change at Day 10, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||-0.2|-2.6|
70907915|NCT03954158|141304224|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-2.4|-0.1||||||Change at Day 11, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.1|-2.4|
70907916|NCT03954158|141304224|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|95.0|-2.2|-0.1||||||Change at Day 11, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.1|-2.2|
70907917|NCT03954158|141304224|OTHER||Difference of least squares mean|-0.8|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|95.0|-2.2|0.5||||||Change at Day 11, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.5|-2.2|
70907918|NCT03954158|141304224|OTHER||Least squares mean of difference|-1.5|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-2.9|0.0||||||Change at Day 12, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.0|-2.9|
70907919|NCT03954158|141304224|OTHER||Least squares mean of difference|-1.6|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-2.4|-0.7||||||Change at Day 12, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.7|-2.4|
70907920|NCT03954158|141304224|OTHER||Difference of least squares mean|-1.6|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-2.9|-0.3||||||Change at Day 12, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||-0.3|-2.9|
70907921|NCT03954158|141304224|OTHER||Least squares mean of difference|-1.1|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|95.0|-2.5|0.3||||||Change at Day 13, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.3|-2.5|
70907922|NCT03954158|141304224|OTHER||Least squares mean of difference|-1.5|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-2.4|-0.6||||||Change at Day 13, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.6|-2.4|
70907923|NCT03954158|141304224|OTHER||Difference of least squares mean|-1.7|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-3.0|-0.5||||||Change at Day 13, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||-0.5|-3.0|
70907924|NCT03954158|141304224|OTHER||Least squares mean of difference|-1.6|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-2.5|-0.6||||||Change at Day 14, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.6|-2.5|
70907925|NCT03954158|141304224|OTHER||Difference of least squares mean|-1.6|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|95.0|-2.8|-0.4||||||Change at Day 14, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||-0.4|-2.8|
70907926|NCT03954158|141304224|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-2.5|0.1||||||Change at Day 14, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.1|-2.5|
70907927|NCT03954158|141304224|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|95.0|-2.4|-0.1||||||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.1|-2.4|
70907928|NCT03954158|141304224|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-2.2|-0.3||||||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.3|-2.2|
70907929|NCT03954158|141304224|OTHER||Difference of least squares mean|-1.4|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-2.8|-0.1||||||Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||-0.1|-2.8|
70907930|NCT02080520|141304238|SUPERIORITY|||||||0.31|||||||Mixed Models Analysis|||||||0.31
70907931|NCT02080520|141304239|SUPERIORITY|||||||0.52|||||||Mixed Models Analysis|||||||0.52
70907932|NCT02080520|141304240|SUPERIORITY|||||||0.32|||||||Mixed Models Analysis|||||||0.32
70969921|NCT02873936|141445701|SUPERIORITY||Least Squares Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|1.18||0.007|TWO_SIDED|95.0|0.9|5.5||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.5|0.9|0.007
70969922|NCT02873936|141445702|SUPERIORITY||Difference in Response Rates|15.0|||<|0.001|TWO_SIDED|95.0|6.4|23.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||23.7|6.4|<0.001
70969923|NCT02873936|141445702|SUPERIORITY||Difference in Response Rates|14.1|||<|0.001|TWO_SIDED|95.0|5.7|22.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||22.6|5.7|<0.001
70969924|NCT02873936|141445702|SUPERIORITY||Difference in Response Rates|28.0|||<|0.001|TWO_SIDED|95.0|17.5|38.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||38.5|17.5|<0.001
70969925|NCT02873936|141445702|SUPERIORITY||Difference in Response Rates|17.2|||<|0.001|TWO_SIDED|95.0|7.1|27.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||27.2|7.1|<0.001
70969926|NCT02873936|141445702|SUPERIORITY||Difference in Response Rates|26.7|||<|0.001|TWO_SIDED|95.0|15.8|37.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||37.6|15.8|<0.001
70969927|NCT02873936|141445702|SUPERIORITY||Difference in Response Rates|16.4||||0.002|TWO_SIDED|95.0|5.9|26.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||26.9|5.9|0.002
70969928|NCT02873936|141445703|SUPERIORITY||Difference in Response Rates|3.4||||0.16|TWO_SIDED|95.0|-1.9|8.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||8.8|-1.9|0.16
70969929|NCT02873936|141445703|SUPERIORITY||Difference in Response Rates|5.8||||0.039|TWO_SIDED|95.0|0.0|11.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||11.6|-0.0|0.039
70969930|NCT02873936|141445703|SUPERIORITY||Difference in Response Rates|15.0|||<|0.001|TWO_SIDED|95.0|6.5|23.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||23.5|6.5|<0.001
70969931|NCT02873936|141445703|SUPERIORITY||Difference in Response Rates|7.6||||0.036|TWO_SIDED|95.0|0.1|15.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||15.2|0.1|0.036
70969932|NCT02873936|141445703|SUPERIORITY||Difference in Response Rates|23.9|||<|0.001|TWO_SIDED|95.0|14.5|33.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||33.3|14.5|<0.001
70969933|NCT02873936|141445703|SUPERIORITY||Difference in Response Rates|12.2||||0.004|TWO_SIDED|95.0|3.7|20.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||20.6|3.7|0.004
70969934|NCT02873936|141445704|SUPERIORITY||Difference in Response Rates|26.0|||<|0.001|TWO_SIDED|95.0|14.6|37.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||37.4|14.6|<0.001
71091983|NCT00393367|141690545|SUPERIORITY_OR_OTHER|||||||0.44||95.0||||The difference in median improvement between treatment groups was expected to be greater than 2.|Wilcoxon (Mann-Whitney)|||||||0.44
70907933|NCT03230864|141304266|SUPERIORITY||Mean Difference (Final Values)|5.47||||0.0809|TWO_SIDED|95.0|-0.7|11.65|||Mixed Model Repeated Measures|||The mean changes from randomization in PANNS total score was analysed using a mixed model for repeated measures (MMRM) approach. The model will include the fixed, categorical effects of treatment, strata, visit, treatment-by-visit interaction, fixed covariates of baseline scores and baseline scores-by-visit interaction. An unstructured (co)variance structure will be used to model the within-patient errors. The Kenward-Roger approximation will be used to estimate denominator degrees of freedom.||11.65|-0.70|0.0809
70969935|NCT02873936|141445704|SUPERIORITY||Difference in Response Rates|18.8|||<|0.001|TWO_SIDED|95.0|7.5|30.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||30.0|7.5|<0.001
70969936|NCT02873936|141445704|SUPERIORITY||Difference in Response Rates|34.9|||<|0.001|TWO_SIDED|95.0|23.6|46.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||46.3|23.6|<0.001
70969937|NCT02873936|141445704|SUPERIORITY||Difference in Response Rates|20.4|||<|0.001|TWO_SIDED|95.0|8.8|32.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||32.1|8.8|<0.001
70969938|NCT02873936|141445705|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.4||0.003|TWO_SIDED|95.0|-7.0|-1.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-7.0|0.003
71091984|NCT00393367|141690546|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||0.97|TWO_SIDED|95.0|-0.14|0.14|||Chi-squared|||||0.14|-0.14|0.97
71091985|NCT00393367|141690547|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-7.0|6.0|||t-test, 2 sided|||||6|-7|
71091986|NCT00393367|141690548|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|1.6|||TWO_SIDED|95.0|-3.0|3.0|||t-test, 2 sided|||||3|-3|
70969939|NCT02873936|141445705|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.4||0.027|TWO_SIDED|95.0|-6.0|0.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-6.0|0.027
70969940|NCT02873936|141445705|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-8.0|-3.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-8.0|<0.001
70969941|NCT02873936|141445705|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-7.0|-2.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-7.0|<0.001
70969942|NCT02873936|141445705|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-10.0|-4.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-10.0|<0.001
70969943|NCT02873936|141445705|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.5||0.006|TWO_SIDED|95.0|-7.0|-1.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-7.0|0.006
70969944|NCT02873936|141445706|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.0||0.008|TWO_SIDED|95.0|-5.0|-1.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-5.0|0.008
70969945|NCT02873936|141445706|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.0||0.65|TWO_SIDED|95.0|-2.0|1.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.0|-2.0|0.65
70969946|NCT02873936|141445706|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.0|-2.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-5.0|<0.001
70969947|NCT02873936|141445706|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.9||0.008|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|0.008
70907934|NCT00432679|141304276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.81|STANDARD_ERROR_OF_MEAN|0.102|<|0.001|TWO_SIDED|95.0|-1.01|-0.61||Change from Baseline in HbA1c = Treatment+ Baseline HbA1c+ Gender+ body mass index (BMI)|ANCOVA|||||-0.61|-1.01|<0.001
70969948|NCT02873936|141445706|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.0|-2.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-5.0|<0.001
70969949|NCT02873936|141445706|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.9||0.039|TWO_SIDED|95.0|-4.0|0.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-4.0|0.039
71153596|NCT03085797|141799595|SUPERIORITY||Difference in Medians|-0.73|||<|0.001|TWO_SIDED|95.0|-1.11|-0.34||p-Value was based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test||Quantile regression with covariates: treatment,region,Baseline score,Baseline eosinophilcount(BEC). Par. with nasal surgery prior to Wk52/withdrew early with no nasal surgery assigned their worst observed score prior to nasal surgery/study withdrawal|||-0.34|-1.11|<0.001
70907935|NCT00432679|141304277|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-22.1|STANDARD_ERROR_OF_MEAN|5.06|<|0.001|TWO_SIDED|95.0|-32.1|-12.1|||Unpaired t-test|||||-12.1|-32.1|<0.001
70969950|NCT02873936|141445707|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-17.0|-7.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-17.0|<0.001
70969951|NCT02873936|141445707|SUPERIORITY||Least Squares Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-16.0|-5.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-16.0|<0.001
70969952|NCT02873936|141445707|SUPERIORITY||Least Squares Mean Difference|-18.0|STANDARD_ERROR_OF_MEAN|3.0|<|0.001|TWO_SIDED|95.0|-24.0|-12.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-12.0|-24.0|<0.001
70969953|NCT02873936|141445707|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|3.0|<|0.001|TWO_SIDED|95.0|-19.0|-7.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-19.0|<0.001
70969954|NCT02873936|141445707|SUPERIORITY||Least Squares Mean Difference|-18.0|STANDARD_ERROR_OF_MEAN|3.4|<|0.001|TWO_SIDED|95.0|-25.0|-12.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-12.0|-25.0|<0.001
70969955|NCT02873936|141445707|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|3.4|<|0.001|TWO_SIDED|95.0|-19.0|-6.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-19.0|<0.001
70969956|NCT02873936|141445708|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-17.0|-7.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|Mixed effects model for repeated measure|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-17.0|<0.001
70969957|NCT02873936|141445708|SUPERIORITY||Least Squares Mean Difference|-10.0|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-15.0|-5.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-15.0|<0.001
70969958|NCT02873936|141445708|SUPERIORITY||Least Squares Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-22.0|-11.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-11.0|-22.0|<0.001
70969959|NCT02873936|141445708|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-18.0|-7.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-18.0|<0.001
71091987|NCT00393367|141690549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-1.0|1.0|||t-test, 2 sided|||||1|-1|
71091988|NCT00393367|141690550|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.03||||0.69||95.0|-0.2|0.14|||Chi-squared|||||0.14|-0.20|0.69
71091989|NCT00393367|141690551|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.22||||0.08|TWO_SIDED|95.0|-0.02|0.47|||Chi-squared|||||0.47|-0.02|0.08
71153597|NCT03085797|141799596|SUPERIORITY||Difference in Medians|-3.14|||<|0.001|TWO_SIDED|95.0|-4.09|-2.18||p-Value was based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test||Quantile regression with covariates: treatment, region, Baseline score, Baseline BEC. Par. with nasal surgery prior to Wks 49-52/withdrew early with no nasal surgery assigned their worst observed 4-wk mean prior to nasal surgery/study withdrawal.|||-2.18|-4.09|<0.001
71153598|NCT03085797|141799597|SUPERIORITY||Hazard Ratio (Mepolizumab/Placebo)|0.43||||0.003|TWO_SIDED|95.0|0.25|0.76||p-Value was based on Cox Proportional Hazards Model.|Cox Proportional Hazards Model||Analysis using a Cox Proportional Hazards Model with covariates of treatment, geographic region, Baseline total endoscopic score (centrally read), Baseline nasal obstruction VAS, Baseline BEC, number of previous surgeries (1, 2, \>2 as ordinal).|||0.76|0.25|0.003
71091990|NCT00393367|141690552|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.14||||0.22|TWO_SIDED|95.0|-0.37|0.08|||Chi-squared|||||0.08|-0.37|0.22
70907936|NCT00432679|141304278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.718|STANDARD_ERROR_OF_MEAN|0.8102||0.377|TWO_SIDED|95.0|-0.883|2.319|||Unpaired t-test|||||2.319|-0.883|0.377
70907937|NCT00432679|141304279|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.04|STANDARD_ERROR_OF_MEAN|2.094||0.33|TWO_SIDED|95.0|-6.18|2.09|||Unpaired t-test|||||2.09|-6.18|0.330
70907938|NCT00432679|141304280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.473||0.983|TWO_SIDED|95.0|-0.945|0.925|||Unpaired t-test|||||0.925|-0.945|0.983
70907939|NCT00432679|141304281|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|8.22|STANDARD_ERROR_OF_MEAN|3.556||0.022|TWO_SIDED|95.0|1.191|15.248|||Unpaired t-test|||||15.248|1.191|0.022
70907940|NCT00432679|141304282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|8.21|STANDARD_ERROR_OF_MEAN|0.86|<|0.001|TWO_SIDED|95.0|6.52|9.91|||Unpaired t-test|||||9.91|6.52|<0.001
70907941|NCT00432679|141304283|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.65|STANDARD_ERROR_OF_MEAN|0.355||0.069|TWO_SIDED|95.0|-0.05|1.35|||Unpaired t-test||Comparison of leptin.|||1.35|-0.05|0.069
70907942|NCT00432679|141304283|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-888.8|STANDARD_ERROR_OF_MEAN|803.96||0.271|TWO_SIDED|95.0|-2477.7|700.1|||Unpaired t-test||Comparison of hs-CRP|||700.1|-2477.7|0.271
70907943|NCT00432679|141304284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|40.6|||||TWO_SIDED|95.0|27.1|54.1|||||Comparison of HbA1c, decrease by 0.7%|||54.1|27.1|
70907944|NCT00432679|141304284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.8|||||TWO_SIDED|95.0|-0.3|13.8|||||Comparison of HbA1c, fell below 6.5%|||13.8|-0.3|
70907945|NCT00432679|141304284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|40.6|||||TWO_SIDED|95.0|27.1|54.1|||||Comparison of HbA1c, satisfied either 1 or 2|||54.1|27.1|
70907946|NCT00432679|141304284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|23.1|||||TWO_SIDED|95.0|9.5|36.6|||||Comparison of FPG, decrease of 30 milligrams per decilliter|||36.6|9.5|
70907947|NCT00432679|141304284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.9|||||TWO_SIDED|95.0|-5.1|18.9|||||Comparison of FPG, fell below 126 milligrams per deciliter|||18.9|-5.1|
70907948|NCT00432679|141304284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|20.5|||||TWO_SIDED|95.0|5.6|35.3|||||Comparison of FPG, satisfied either 1 or 2|||35.3|5.6|
70907949|NCT00600743|141304289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|128.2|STANDARD_ERROR_OF_MEAN|41.4||0.007|TWO_SIDED|95.0||||t test following ANOVA for difference between drug and placebo - There were 3 doses, and the value reported is for the highest and only effective dose|t-test, 2 sided|The overall error term was used to compare differences between placebo and drug||Repeated measures ANOVA||||0.007
70907950|NCT00600743|141304290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.4|STANDARD_ERROR_OF_MEAN|22.8||0.033|TWO_SIDED|95.0||||t-test after ANOVA with repeated measures on placebo minus drug (within groups) between binge and normal instructions (between groups)|t-test, 2 sided|This was part of an overall ANOVA (SAS proc mixed) with all four groups (3 doses eat normally. 4 ng dose, binge eat) and the error term had 76 df.||Each group was compared separately in an overall ANOVA with all dose groups included. The results are presented for the groups which received 4 mg dose and instructions to eat normally (normal group) or to binge eat (binge group). The test is the interaction between drug and group i.e. drug effect difference (placebo minus drug) in fullness between the group instructed to binge and the group instructed to eat normally.||||.033
70907951|NCT00600743|141304291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.4286|STANDARD_ERROR_OF_MEAN|13.134|<|0.014|TWO_SIDED|||||p-value is based on ANOVA with all groups and conditions and is a planned comparison|ANOVA||df = 53. 26 Used proc GLMMIX in SAS 9.4.|Tests the difference between drug and placebo for group = binge instructions||||<.014
70907952|NCT01177813|141304292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.9|-0.57||Difference calculated as empagliflozin 10mg minus placebo|ANCOVA|||Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, and baseline HbA1c as linear covariate||-0.57|-0.90|<0.0001
70907953|NCT01177813|141304292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-1.01|-0.69||Difference calculated as empagliflozin 25mg minus placebo|ANCOVA|||Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, and baseline HbA1c as linear covariate||-0.69|-1.01|<0.0001
70907954|NCT01177813|141304293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|97.5|-2.48|-1.38||Difference calculated as empagliflozin 10mg minus placebo|ANCOVA|||Model was adjusted for treatment,geographical region,and renal function at baseline as fixed effects,baseline body weight and baseline HbA1c as linear covariate||-1.38|-2.48|<0.0001
70907955|NCT01177813|141304293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-2.7|-1.6||Difference calculated as empagliflozin 25mg minus placebo|ANCOVA|||Model was adjusted for treatment,geographical region,and renal function at baseline as fixed effects,baseline body weight and baseline HbA1c as linear covariate||-1.60|-2.70|<0.0001
70907956|NCT01177813|141304294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6|STANDARD_ERROR_OF_MEAN|1.1||0.0231|TWO_SIDED|97.5|-5.2|0.0||Difference calculated as empagliflozin 10mg minus placebo|ANCOVA|||"Comparison for Systolic Blood Pressure~Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, baseline SBP and baseline HbA1c as linear covariate"||0.0|-5.2|0.0231
70907957|NCT01177813|141304294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|1.1||0.0028|TWO_SIDED|97.5|-6.0|-0.9||Difference calculated as empagliflozin 25mg minus placebo|ANCOVA|||"Comparison for Systolic blood pressure~Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, baseline SBP and baseline HbA1c as linear covariate"||-0.9|-6.0|0.0028
70907958|NCT01177813|141304294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.7||0.3987|TWO_SIDED|97.5|-2.1|0.9||Difference calculated as empagliflozin 10mg minus placebo|ANCOVA|||"Comparison for diastolic blood pressure~Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, baseline DBP and baseline HbA1c as linear covariate"||0.9|-2.1|0.3987
70907959|NCT01177813|141304294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.7||0.0296|TWO_SIDED|97.5|-3.0|0.0||Difference calculated as empagliflozin 25mg minus placebo|ANCOVA|||"Comparison for diastolic blood pressure~Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, baseline DBP and baseline HbA1c as linear covariate"||0.0|-3.0|0.0296
70907960|NCT00581256|141304296|SUPERIORITY_OR_OTHER|||||||0.6|||||||Fisher Exact|||A Perfusion Defect (PD) increase of greater than 5% for a 2.5 SD threshold was considered significant.||||0.6
70907961|NCT00581256|141304296|SUPERIORITY_OR_OTHER|||||||0.46|||||||Fisher Exact|||A PD increase of greater than 10% for a 1.5 SD threshold was considered significant.||||0.46
70907962|NCT01196104|141304304|NON_INFERIORITY_OR_EQUIVALENCE|Study terminated early due to business reasons, results are not properly powered.|Mean Difference (Final Values)|-0.0473|STANDARD_ERROR_OF_MEAN|0.2158||0.8283|TWO_SIDED|95.0|-0.4901|0.3956|||ANCOVA|||ANCOVA model with terms of treatment as a fixed effect and baseline HbA1c as covariate||0.3956|-0.4901|0.8283
70907963|NCT01183650|141304388|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|1.05|||||TWO_SIDED|90.0|0.84|1.32|||||Day 1 Tadalafil Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||1.32|0.84|
70907964|NCT01183650|141304388|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.8|||||TWO_SIDED|90.0|0.64|1.0|||||Day 10 Tadalafil Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||1.00|0.64|
70907965|NCT01183650|141304388|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|1.31|||||TWO_SIDED|90.0|1.05|1.64|||||Day 1 Metabolite IC710 Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||1.64|1.05|
70907966|NCT01183650|141304388|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.99|||||TWO_SIDED|90.0|0.79|1.24|||||Day 10 Metabolite IC710 Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||1.24|0.79|
70907967|NCT01183650|141304389|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.98|||||TWO_SIDED|90.0|0.81|1.18|||||Day 1 Tadalafil Ratio of Geometric Least Squares Means(Japanese/Caucasian)|||1.18|0.81|
70907968|NCT01183650|141304389|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.81|||||TWO_SIDED|90.0|0.67|0.97|||||Day 10 Tadalafil Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||0.97|0.67|
70907969|NCT01183650|141304389|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Mean|1.33|||||TWO_SIDED|90.0|1.07|1.67|||||Day 1 Metabolite IC710 Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||1.67|1.07|
70907970|NCT01183650|141304389|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|1.03|||||TWO_SIDED|90.0|0.83|1.29|||||Day 10 Metabolite IC710 Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||1.29|0.83|
70907971|NCT01183650|141304390|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||||95.0|||||Wilcoxon (Mann-Whitney)|Tadalafil Median Difference (Day 1 - Day 10) in Japanese Participants||||||
70907972|NCT01183650|141304390|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||||95.0|||||Wilcoxon (Mann-Whitney)|Tadalafil Median Difference (Day 1 - Day 10) in Caucasian Participants||||||
70907973|NCT01183650|141304390|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|19.83||||||95.0|||||Wilcoxon (Mann-Whitney)|Metabolite IC710 Median Difference (Day 1 - Day 10) in Japanese participants||||||
70907974|NCT01183650|141304390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.02||||||95.0|||||Wilcoxon (Mann-Whitney)|Metabolite IC710 Median Difference (Day 1 - Day 10) in Caucasian participants||||||
70907975|NCT01284140|141304391|OTHER|||||||0.37|||||||Extra sum-of-squares F test|The null hypothesis that model parameters of amplitude and phase were the same on Day 1 and Day 3 was not rejected for the Usual Care group.||Nonlinear regression using the least-squares approach was used to fit a single 24-hour cosine curve to all normalized data in each group on each day of 24-hour urine collection. Model parameters of acrophase and amplitude and their standard errors were derived from these curves. Using the extra sum-of-squares F test, the null hypothesis that model parameters of amplitude and phase were the same on Day 1 and Day 3 was tested for the Usual Care group.||||0.37
70907976|NCT01284140|141304391|OTHER|||||||0.0074|||||||Extra sum-of-squares F test|This result suggests that the best-fit values for amplitude and phase are different between Day 1 and Day 3 in the Sleep Promotion group.||Nonlinear regression using the least-squares approach was used to fit a single 24-hour cosine curve to all normalized data in each group on each day of 24-hour urine collection. Model parameters of acrophase and amplitude and their standard errors were derived from these curves. Using the extra sum-of-squares F test, the null hypothesis that model parameters of amplitude and phase were the same on Day 1 and Day 3 was tested for the Sleep promotion group.||||0.0074
70907977|NCT01284140|141304392|SUPERIORITY|||||||0.55|||||||Fisher Exact|||||||0.55
70907978|NCT01284140|141304393|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.03|TWO_SIDED||||||t-test, 2 sided|||Nonlinear regression using the least-squares approach was used to fit a single 24-hour cosine curve to all normalized data in each group on each day of 24-hour urine collection. This resulted in 4 separate best-fit curves. The model parameter of amplitude was derived from the best-fit curves.||||0.03
70907979|NCT03192215|141304408|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.99|TWO_SIDED|95.0|0.64|1.55|||Log Rank|||||1.55|0.64|0.99
70907980|NCT03192215|141304409|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.72|TWO_SIDED|95.0|0.59|1.44|||Log Rank|||||1.44|0.59|0.72
70907981|NCT03192215|141304410|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.67|TWO_SIDED|95.0|0.76|1.52|||Log Rank|||||1.52|0.76|0.67
70907982|NCT03192215|141304411|SUPERIORITY||Difference of annual rate.|-0.011||||0.02|TWO_SIDED|95.0|-0.018|-0.003|||Exact Binomial Test|||||-0.003|-0.018|.02
70907983|NCT03192215|141304412|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.98|TWO_SIDED|95.0|0.29|3.52|||Log Rank|||||3.52|0.29|0.98
70907984|NCT03192215|141304413|SUPERIORITY||Hazard Ratio (HR)|1.53||||0.35|TWO_SIDED|95.0|0.63|3.75|||Log Rank|||||3.75|0.63|0.35
70907985|NCT02593032|141304414|SUPERIORITY||Mean Difference (Net)|12.0|||<|0.05|TWO_SIDED|||||This is the calculated p-value, not a threshold.|t-test, 2 sided|||||||<0.05
70907986|NCT02258464|141304437|OTHER||Hazard Ratio (Radium 223/Placebo)|0.745||||0.3339|TWO_SIDED|80.0|0.504|1.102||The SSE-FS was compared using a stratified log-rank test with a 2-sided alpha of 0.2|Log Rank|||The null hypothesis that both treatment groups have the same SSE-FS distribution will be tested against the alternative hypothesis that the distribution of SSE-FS time in radium-223 dichloride is different from the placebo group||1.102|0.504|0.3339
70907987|NCT02258464|141304438|OTHER||Hazard ratio (Radium 223/Placebo)|0.888||||0.7259|TWO_SIDED|80.0|0.576|1.37|||Log Rank|||||1.370|0.576|0.7259
70907988|NCT02258464|141304439|OTHER||Hazard ratio (Radium 223/Placebo)|0.932||||0.8785|TWO_SIDED|80.0|0.513|1.693|||Log Rank|||||1.693|0.513|0.8785
70907989|NCT02258464|141304440|OTHER||Hazard ratio (Radium 223/Placebo)|0.824||||0.524|TWO_SIDED|80.0|0.556|1.22|||Log Rank|||||1.220|0.556|0.5240
70907990|NCT02258464|141304441|OTHER||Difference (Radium 223 - Placebo) %|11.8||||0.345|TWO_SIDED|80.0|-2.7|26.3|||Cochran-Mantel-Haenszel|||||26.3|-2.7|0.345
70907991|NCT02258464|141304442|OTHER||Hazard ratio (Radium 223/Placebo)|0.968||||0.9128|TWO_SIDED|80.0|0.657|1.425|||Log Rank|||||1.425|0.657|0.9128
70907992|NCT02258464|141304443|OTHER||Hazard ratio (Radium 223/Placebo)|1.023||||0.9227|TWO_SIDED|80.0|0.753|1.391|||Log Rank|||||1.391|0.753|0.9227
70907993|NCT01755689|141304480|NON_INFERIORITY|The non-inferiority criteria: the upper limit (UL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|1.19|||||TWO_SIDED|95.0|0.99|1.43|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix+Boostrix Group in terms of rSBA-MenA titers.||1.43|0.99|
70907994|NCT01755689|141304480|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|1.01|||||TWO_SIDED|95.0|0.84|1.21|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix Group in terms of rSBA-MenA titers.||1.21|0.84|
70907995|NCT01755689|141304480|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|1.19|||||TWO_SIDED|95.0|0.93|1.51|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix+Boostrix Group in terms of rSBA-MenC titers.||1.51|0.93|
70907996|NCT01755689|141304480|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|0.83|||||TWO_SIDED|95.0|0.66|1.06|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix Group in terms of rSBA-MenC titers.||1.06|0.66|
70907997|NCT01755689|141304480|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|1.26|||||TWO_SIDED|95.0|0.97|1.64|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix+Boostrix Group in terms of rSBA-MenW-135 titers.||1.64|0.97|
70907998|NCT01755689|141304480|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|0.82|||||TWO_SIDED|95.0|0.63|1.07|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix Group in terms of rSBA-MenW-135 titers.||1.07|0.63|
70907999|NCT01755689|141304480|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|1.05|||||TWO_SIDED|95.0|0.89|1.24|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix+Boostrix Group in terms of rSBA-MenY titers.||1.24|0.89|
70908000|NCT01755689|141304480|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|0.95|||||TWO_SIDED|95.0|0.8|1.12|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix Group in terms of rSBA-MenY titers.||1.12|0.80|
70908001|NCT01755689|141304481|NON_INFERIORITY|For HPV-16, one month after the third dose of Cervarix, the UL of the two-sided standardized asymptotic 95% CI on the group GMT ratio had to be below the pre-defined limit of 2.|Adjusted GMT|0.97|||||TWO_SIDED|95.0|0.81|1.15|||ANCOVA|||Adjusted GMT ratio of the Cervarix Group versus Nimenrix+Cervarix (0,1,6-Month) Group in terms of HPV-16 titers.||1.15|0.81|
70908002|NCT01755689|141304481|NON_INFERIORITY|For HPV-18, one month after the third dose of Cervarix, the UL of the two-sided standardized asymptotic 95% CI on the group GMT ratio had to be below the pre-defined limit of 2.|Adjusted GMT|1.09|||||TWO_SIDED|95.0|0.92|1.29|||ANCOVA|||Adjusted GMT ratio of the Cervarix Group versus Nimenrix+Cervarix (0,1,6-Month) Group in terms of HPV-18 titers.||1.29|0.92|
70908003|NCT01755689|141304481|NON_INFERIORITY|For HPV-16, one month after the third dose of Cervarix, the UL of the two-sided standardized asymptotic 95% CI on the group GMT ratio had to be below the pre-defined limit of 2.|Adjusted GMT|1.2|||||TWO_SIDED|95.0|1.01|1.43|||ANCOVA|||Adjusted GMT ratio of the Boostrix+Cervarix Group versus Nimenrix+Cervarix+Boostrix Group in terms of HPV-16 titers.||1.43|1.01|
70908004|NCT01755689|141304481|NON_INFERIORITY|For HPV-18, one month after the third dose of Cervarix, the UL of the two-sided standardized asymptotic 95% CI on the group GMT ratio had to be below the pre-defined limit of 2.|Adjusted GMT|1.19|||||TWO_SIDED|95.0|1.0|1.41|||ANCOVA|||Adjusted GMT ratio of the Boostrix+Cervarix Group versus Nimenrix+Cervarix+Boostrix Group in terms of HPV-18 titers.||1.41|1.00|
70908005|NCT01755689|141304482|NON_INFERIORITY|For anti-D the lower limit (LL) of the 2-sided standardised asymptotic 95% CI for the group difference (Nimenrix+Cervarix+Boostrix Group minus Boostrix +Cervarix Group) had to be greater than or equal to the pre-defined limit of -10%.|Difference between groups|-2.88|||||TWO_SIDED|95.0|-6.9|0.81||||||The group difference of the Nimenrix+Cervarix+Boostrix Group and Boostrix+Cervarix Group in terms of Anti-D titers.||0.81|-6.90|
70908006|NCT01755689|141304482|NON_INFERIORITY|For anti-T the LL of the 2-sided standardised asymptotic 95% CI for the group difference (Nimenrix+Cervarix+Boostrix Group minus Boostrix +Cervarix Group) had to be greater than or equal to the pre-defined limit of -10%.|Difference between groups|-0.4|||||TWO_SIDED|95.0|-2.23|1.08||||||The group difference of the Nimenrix+Cervarix+Boostrix Group and Boostrix+Cervarix Group in terms of Anti-T titers.||1.08|-2.23|
70908007|NCT01755689|141304483|NON_INFERIORITY|For anti-PRN the UL of the 2-sided standardised asymptotic 95% CI for the adjusted group ratio of GMCs (Nimenrix+Cervarix+Boostrix Group/Boostrix+Cervarix Group) had to be less than or equal to the pre-defined limit of 1.5.|Adjusted GMT Ratio|1.53|||||TWO_SIDED|95.0|1.25|1.87|||ANCOVA|||Adjusted GMT ratio of the Nimenrix+Cervarix+Boostrix Group versus Boostrix+ Cervarix Group in terms of anti-PRN titers.||1.87|1.25|
70908008|NCT01755689|141304483|NON_INFERIORITY|For anti-FHA the UL of the 2-sided standardised asymptotic 95% CI for the adjusted group ratio of GMCs (Nimenrix+Cervarix+Boostrix Group/Boostrix+Cervarix Group) had to be less than or equal to the pre-defined limit of 1.5.|Adjusted GMT Ratio|1.65|||||TWO_SIDED|95.0|1.42|1.93|||ANCOVA|||Adjusted GMT ratio of the Nimenrix+Cervarix Group versus Boostrix+ Cervarix Group in terms of anti-FHA titers.||1.93|1.42|
71091991|NCT00393367|141690554|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.36||0.78|TWO_SIDED|95.0|-0.6|0.8|||t-test, 2 sided|||||0.8|-0.6|0.78
71091992|NCT03286504|141690557|SUPERIORITY||proportion difference|0.05||||0.55|TWO_SIDED|95.0|-0.112|0.212|||Chi-squared||Direction of proportion difference = FANMI arm minus Standard of Care arm|||0.212|-0.112|0.55
70908009|NCT01755689|141304483|NON_INFERIORITY|For anti-PT the UL of the 2-sided standardised asymptotic 95% CI for the adjusted group ratio of GMCs (Nimenrix+Cervarix+Boostrix Group/Boostrix+Cervarix Group) had to be less than or equal to the pre-defined limit of 1.5.|Adjusted GMT Ratio|1.39|||||TWO_SIDED|95.0|1.2|1.61|||ANCOVA|||Adjusted GMT ratio of the Nimenrix+Cervarix Group versus Boostrix+ Cervarix Group in terms of anti-PT titers.||1.61|1.20|
70908010|NCT01327547|141304501|SUPERIORITY_OR_OTHER||Difference in proportion|-0.002||||0.4598|TWO_SIDED|95.0|-0.0417|0.0376|||Cochran-Mantel-Haenszel||Difference in proportion: CMH approach weighted by hepatitis B virus (HBV) status and usage of protease inhibitor (PI) regimen strata was used to calculate the statistics.|A stratified analysis was conducted by summarizing the difference in proportions adjusted for the randomization strata formed by crossing levels of stratification variables. The Cochran-Mantel-Haenszel (CMH) approach was used. No formal hypothesis test was performed.||0.0376|-0.0417|0.4598
70908011|NCT01327547|141304502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0167|||||TWO_SIDED|95.0|-0.0653|0.0319|||||CMH approach weighted by HBV status and usage of PI regiment strata, is used to calculate the statistics. The point estimate and 95% CI are difference in proportions between MVC and placebo for the participants meeting secondary endpoint.|||0.0319|-0.0653|
70908012|NCT01327547|141304502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0177|||||TWO_SIDED|95.0|-0.0805|0.0452|||||CMH approach weighted by HBV status and usage of PI regiment strata, is used to calculate the statistics. The point estimate and 95% CI are difference in proportions between maraviroc and placebo for the participants meeting secondary endpoint.|||0.0452|-0.0805|
70908013|NCT01327547|141304507|SUPERIORITY_OR_OTHER||Difference in proportion|-0.015|||||TWO_SIDED|95.0|-0.1484|0.1185|||||Difference in proportion: CMH approach weighted by HBV status and usage of PI regimen strata was used to calculate the statistics.|A stratified analysis was conducted by summarizing the difference in proportions adjusted for the randomization strata formed by crossing levels of stratification variables. The CMH approach was used. No formal hypothesis test was performed. Week 48 data presented here.||0.1185|-0.1484|
70908014|NCT01327547|141304507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0255|||||TWO_SIDED|95.0|-0.1784|0.1274|||||Difference in proportion: CMH approach weighted by HBV status and usage of PI regimen strata was used to calculate the statistics.|A stratified analysis was conducted by summarizing the difference in proportions adjusted for the randomization strata formed by crossing levels of stratification variables. The CMH approach was used. No formal hypothesis test was performed. Week 96 data presented here.||0.1274|-0.1784|
70908015|NCT01327547|141304507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.083|||||TWO_SIDED|95.0|-0.2421|0.0761|||||Difference in proportion: CMH approach weighted by HBV status and usage of PI regimen strata was used to calculate the statistics.|A stratified analysis was conducted by summarizing the difference in proportions adjusted for the randomization strata formed by crossing levels of stratification variables. The CMH approach was used. No formal hypothesis test was performed. Week 144 data presented here.||0.0761|-0.2421|
70908016|NCT01327547|141304508|SUPERIORITY_OR_OTHER||Difference in Least Square (LS) Mean|-41.12||||0.1174|TWO_SIDED|95.0|-92.72|10.49|||ANCOVA||Difference in Least Square (LS) Mean|The above analysis is for CD4+ cells at week 48. Results are from an analysis of covariance (ANCOVA) model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.||10.49|-92.72|0.1174
70908017|NCT01327547|141304508|SUPERIORITY_OR_OTHER||Difference in LS Mean|-21.96||||0.593|TWO_SIDED|95.0|-103.05|59.12|||ANCOVA||Difference in LS Mean|The above analysis is for CD8+ cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.||59.12|-103.05|0.5930
70908018|NCT01327547|141304508|SUPERIORITY_OR_OTHER||Difference in LS Mean|-48.26||||0.0669|TWO_SIDED|95.0|-99.93|3.41|||ANCOVA|||The above analysis is for CD4+ cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.||3.41|-99.93|0.0669
70908019|NCT01327547|141304508|SUPERIORITY_OR_OTHER||Difference in LS Mean|-65.28||||0.1799|TWO_SIDED|95.0|-161.07|30.5|||ANCOVA|||The above analysis is for CD8+ cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.||30.50|-161.07|0.1799
70908020|NCT01327547|141304508|SUPERIORITY_OR_OTHER||Difference in LS Mean|-27.71||||0.3859|TWO_SIDED|95.0|-90.71|35.29|||ANCOVA|||The above analysis is for CD4+ cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.||35.29|-90.71|0.3859
70969960|NCT02873936|141445708|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-18.0|-8.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.0|-18.0|<0.001
70908021|NCT01327547|141304508|SUPERIORITY_OR_OTHER||Difference in LS Mean|-31.86||||0.5571|TWO_SIDED|95.0|-138.93|75.21|||ANCOVA|||The above analysis is for CD8+ cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.||75.21|-138.93|0.5571
70908022|NCT01327547|141304509|SUPERIORITY_OR_OTHER||Difference in LS Mean|-56.06||||0.0153|TWO_SIDED|95.0|-101.2|-10.92|||ANCOVA||Difference in LS Mean|The above analysis is for CD38 expression on CD4 and CD8 cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||-10.92|-101.20|0.0153
71091993|NCT03286504|141690558|SUPERIORITY||proportion difference|0.033||||0.71|TWO_SIDED|95.0|-0.145|0.211|||Chi-squared||Direction of proportion difference = FANMI arm minus Standard of Care arm|||0.211|-0.145|0.71
70908023|NCT01327547|141304509|SUPERIORITY_OR_OTHER||Difference in LS Mean|-44.93||||0.0947|TWO_SIDED|95.0|-97.72|7.87|||ANCOVA|||The above analysis is for CD38 expression on CD4 and CD8 cells for Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||7.87|-97.72|0.0947
70908024|NCT01327547|141304509|SUPERIORITY_OR_OTHER||Difference in LS Mean|-29.75||||0.3595|TWO_SIDED|95.0|-93.74|34.24|||ANCOVA|||The above analysis is for CD38 expression on CD4 and CD8 cells for Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||34.24|-93.74|0.3595
70908025|NCT01327547|141304510|SUPERIORITY_OR_OTHER||Difference in LS Mean|-2.53||||0.4476|TWO_SIDED|95.0|-9.11|4.05|||ANCOVA||Difference in LS Mean|The above analysis is for C-reactive protein cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||4.05|-9.11|0.4476
70908026|NCT01327547|141304510|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.67||||0.3012|TWO_SIDED|95.0|-0.61|1.96|||ANCOVA|||The above analysis is for C-reactive protein cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||1.96|-0.61|0.3012
70908027|NCT01327547|141304510|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.92||||0.4196|TWO_SIDED|95.0|-1.33|3.17|||ANCOVA|||The above analysis is for C-reactive protein cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||3.17|-1.33|0.4196
70908028|NCT01327547|141304511|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.3||||0.9904|TWO_SIDED|95.0|-48.66|49.26||Not specifed.|ANCOVA||Difference in LS Mean|The above analysis is for D-Dimer cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||49.26|-48.66|0.9904
70908029|NCT01327547|141304511|SUPERIORITY_OR_OTHER||Difference in LS Mean|10.87||||0.7697|TWO_SIDED|95.0|-62.44|84.18|||ANCOVA||Difference in LS Mean|The above analysis is for D-Dimer cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||84.18|-62.44|0.7697
70908030|NCT01327547|141304511|SUPERIORITY_OR_OTHER||Difference in LS Mean|-24.49||||0.5816|TWO_SIDED|95.0|-112.21|63.23|||ANCOVA||Difference in LS Mean|The above analysis is for D-Dimer cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||63.23|-112.21|0.5816
70908031|NCT01327547|141304512|SUPERIORITY_OR_OTHER||Difference in LS Mean|498.04||||0.3786|TWO_SIDED|95.0|-617.33|1613.41|||ANCOVA||Difference in LS Mean|The above analysis is for TGF-beta cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||1613.41|-617.33|0.3786
70908032|NCT01327547|141304512|SUPERIORITY_OR_OTHER||Difference in LS Mean|348.7||||0.4388|TWO_SIDED|95.0|-539.61|1237.01|||ANCOVA||Difference in LS Mean|The above analysis is for TGF-beta cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||1237.01|-539.61|0.4388
70908033|NCT01327547|141304512|SUPERIORITY_OR_OTHER||Difference in LS Mean|-173.57||||0.8559|TWO_SIDED|95.0|-2060.81|1713.68|||ANCOVA||Difference in LS Mean|The above analysis is for TGF-beta cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||1713.68|-2060.81|0.8559
70908034|NCT01327547|141304513|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.03||||0.8024|TWO_SIDED|95.0|-0.22|0.28|||ANCOVA||Difference in LS Mean|The above analysis is change for baseline in Log10 plasma HCV RNA at 48 Weeks. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.28|-0.22|0.8024
70908035|NCT01327547|141304513|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.15||||0.266|TWO_SIDED|95.0|-0.12|0.43|||ANCOVA||Difference in LS Mean|The above analysis is change for baseline in Log10 plasma HCV RNA at 96 Weeks. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.43|-0.12|0.2660
70908036|NCT01327547|141304513|SUPERIORITY_OR_OTHER||Difference in LS mean|0.15||||0.2855|TWO_SIDED|95.0|-0.12|0.41|||ANCOVA||Difference in LS mean|The above analysis is change for baseline in Log10 plasma HCV RNA at 144 Weeks. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.41|-0.12|0.2855
70908037|NCT01327547|141304514|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.15||||0.7778|TWO_SIDED|95.0|-0.93|1.23|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 48 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||1.23|-0.93|0.7778
70908038|NCT01327547|141304514|SUPERIORITY_OR_OTHER||Difference in LS mean|0.0||||0.9991|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 96 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.10|-0.10|0.9991
70908039|NCT01327547|141304514|SUPERIORITY_OR_OTHER||Difference in LS mean|-0.02||||0.7275|TWO_SIDED|95.0|-0.16|0.11|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 144 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.11|-0.16|0.7275
70908040|NCT01327547|141304515|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.07||||0.5201|TWO_SIDED|95.0|-0.15|0.3|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 48 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.30|-0.15|0.5201
70908041|NCT01327547|141304515|SUPERIORITY_OR_OTHER||Difference in LS Mean|-0.08||||0.4657|TWO_SIDED|95.0|-0.28|0.13|||ANCOVA|||Results are from an ANCOVA model with change from baseline at Week 96 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.13|-0.28|0.4657
70908042|NCT01327547|141304515|SUPERIORITY_OR_OTHER||Difference in LS Mean|-0.03||||0.8087|TWO_SIDED|95.0|-0.25|0.2|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 144 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.20|-0.25|0.8087
70908043|NCT01327547|141304516|SUPERIORITY_OR_OTHER||Difference in LS Mean|-1.84||||0.1417|TWO_SIDED|95.0|-4.31|0.63|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 48 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.63|-4.31|0.1417
70908044|NCT01327547|141304516|SUPERIORITY_OR_OTHER||Difference in LS Mean|-1.44||||0.2679|TWO_SIDED|95.0|-4.01|1.14|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 96 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||1.14|-4.01|0.2679
70908045|NCT01327547|141304516|SUPERIORITY_OR_OTHER||Difference in LS Mean|-1.48||||0.1366|TWO_SIDED|95.0|-3.45|0.49|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 144 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.49|-3.45|0.1366
70908046|NCT03699124|141304534|EQUIVALENCE|Equivalence between two lot groups is demonstrated if the confidence interval of the ratio of the GMTs lies within the interval \[½, 2\]. For the trial to be successful, all three lot group comparisons must be equivalent by this definition.|GMT Ratio|0.936|||||TWO_SIDED|95.0|0.816|1.073||||||||1.073|0.816|
70908047|NCT03699124|141304534|EQUIVALENCE|Equivalence between two lot groups is demonstrated if the confidence interval of the ratio of the GMTs lies within the interval \[½, 2\]. For the trial to be successful, all three lot group comparisons must be equivalent by this definition.|GMT Ratio|1.115|||||TWO_SIDED|95.0|0.967|1.287||||||||1.287|0.967|
70908048|NCT03699124|141304534|EQUIVALENCE|Equivalence between two lot groups is demonstrated if the confidence interval of the ratio of the GMTs lies within the interval \[½, 2\]. For the trial to be successful, all three lot group comparisons must be equivalent by this definition.|GMT Ratio|1.044|||||TWO_SIDED|95.0|0.915|1.191||||||||1.191|0.915|
70908049|NCT00506285|141304547|NON_INFERIORITY_OR_EQUIVALENCE|F(1,47)=26.7, p=.001||||||0.001|TWO_SIDED|95.0|||||Mixed Models Analysis|F(1,47)=26.7, p=.001||||||.001
70908050|NCT00506285|141304548|NON_INFERIORITY_OR_EQUIVALENCE|mixed models analysis||||||0.001|TWO_SIDED|95.0||||F(1,47)=24.8, p=.001|Mixed Models Analysis|||||||.001
70908051|NCT01089556|141304549|SUPERIORITY_OR_OTHER||LS Mean Differences (Final Values)|-0.192||||0.37||95.0|||||Mixed Models Analysis|||||||0.370
70908052|NCT01089556|141304550|SUPERIORITY_OR_OTHER||LS Mean Differences (Final Values)|-0.614|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
71091994|NCT03286504|141690560|SUPERIORITY||proportion difference|-0.05||||0.65|TWO_SIDED|95.0|-0.269|0.169|||Chi-squared||Direction of proportion difference = FANMI arm minus Standard of Care arm|||0.169|-0.269|0.65
70908053|NCT01089556|141304551|SUPERIORITY_OR_OTHER||LS Mean Differences (Final Values)|-0.003||||0.991||95.0|||||Mixed Models Analysis|||||||0.991
70908054|NCT01089556|141304552|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.431|||<|0.001|TWO_SIDED|95.0|1.233|1.662|||Cochran-Mantel-Haenszel|||||1.662|1.233|<0.001
70908055|NCT01089556|141304553|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.052||||0.565|TWO_SIDED|95.0|0.884|1.253|||Cochran-Mantel-Haenszel|||||1.253|0.884|0.565
70908056|NCT01089556|141304554|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.467|||<|0.001|TWO_SIDED|95.0|1.214|1.771|||Cochran-Mantel-Haenszel|||||1.771|1.214|<0.001
70908057|NCT01089556|141304555|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.233||||0.068|TWO_SIDED|95.0|0.98|1.55|||Cochran-Mantel-Haenszel|||||1.550|0.980|0.068
70908058|NCT01089556|141304556|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.279|||<|0.001|TWO_SIDED|95.0|1.125|1.456|||Cochran-Mantel-Haenszel|||||1.456|1.125|<0.001
70908059|NCT01089556|141304557|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.985||||0.843|TWO_SIDED|95.0|0.842|1.151|||Cochran-Mantel-Haenszel|||||1.151|0.842|0.843
70908060|NCT01089556|141304558|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.341|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
70908061|NCT01089556|141304559|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.073||||0.475||95.0|||||Mixed Models Analysis|||||||0.475
70908062|NCT01089556|141304560|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-4.758|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
70908063|NCT01089556|141304561|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-1.933||||0.289||95.0|||||Mixed Models Analysis|||||||0.289
70908064|NCT01089556|141304562|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-1.02||||0.071||95.0|||||ANCOVA|||||||0.071
70908065|NCT01089556|141304563|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.193||||0.78||95.0|||||ANCOVA|||||||0.780
70908066|NCT01089556|141304564|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.558||||0.008||95.0||||P-value is for anxiety subscale score.|Mixed Models Analysis|||||||0.008
70908067|NCT01089556|141304564|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.423||||0.031||95.0||||p-value is for depression subscale score.|Mixed Models Analysis|||||||0.031
70908068|NCT01089556|141304565|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.615||||0.049||95.0||||P-value is for anxiety subscale score.|Mixed Models Analysis|||||||0.049
70908069|NCT01089556|141304565|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.378||||0.198||95.0||||P-value is for depression subscale score.|Mixed Models Analysis|||||||0.198
71091995|NCT03286504|141690561|SUPERIORITY||proportion difference|0.226||||0.04|TWO_SIDED|95.0|0.015|0.438|||Chi-squared||Direction of proportion difference = FANMI arm minus Standard of Care arm|||0.438|0.015|0.04
70908070|NCT01089556|141304570|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.343|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
70908071|NCT01089556|141304571|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.095||||0.385||95.0|||||Mixed Models Analysis|||||||0.385
70908072|NCT01089556|141304572|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-2.02||||0.064||95.0||||P-value is for systolic BP.|ANCOVA|||||||0.064
70908073|NCT01089556|141304572|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|0.135||||0.843||95.0||||P-value is for diastolic BP.|ANCOVA|||||||0.843
70908074|NCT01089556|141304573|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-1.329||||0.354||95.0||||P-value is for systolic BP.|ANCOVA|||||||0.354
70908075|NCT01089556|141304573|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.003||||0.997||95.0||||P-value is for diastolic BP.|ANCOVA|||||||0.997
70908076|NCT01089556|141304574|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|3.317|||<|0.001||95.0|||||ANCOVA|||||||<0.001
70908077|NCT01089556|141304575|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.942||||0.332||95.0|||||ANCOVA|||||||0.332
70908078|NCT01089556|141304576|SUPERIORITY_OR_OTHER|||||||0.618||95.0|||||Fisher Exact|||||||0.618
70908079|NCT01089556|141304577|SUPERIORITY_OR_OTHER|||||||0.571||95.0|||||Fisher Exact|||||||0.571
70908080|NCT01089556|141304578|SUPERIORITY_OR_OTHER|||||||0.744||95.0|||||Fisher Exact|||||||0.744
70908081|NCT01089556|141304579|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.000
70908082|NCT03405662|141304596|SUPERIORITY|||||||0.07|||||||non-parametric Kolmogorov-Smirnov test|||||||0.07
70908083|NCT03405662|141304597|SUPERIORITY|||||||0.29|||||||non-parametric Kolmogorov-Smirnov test|||||||0.29
70908084|NCT03405662|141304598|SUPERIORITY|||||||0.07|||||||non-parametric Kolmogorov-Smirnov test|||||||0.07
70908085|NCT03405662|141304599|SUPERIORITY|||||||0.23|||||||non-parametric Kolmogorov-Smirnov test|||||||0.23
70908086|NCT03405662|141304600|SUPERIORITY|||||||0.68|||||||non-parametric Kolmogorov-Smirnov test|||||||0.68
70908087|NCT03405662|141304601|SUPERIORITY|||||||0.13|||||||non-parametric Kolmogorov-Smirnov test|||||||0.13
70908088|NCT03405662|141304602|SUPERIORITY|||||||0.32|||||||non-parametric Kolmogorov-Smirnov test|||||||0.32
70908089|NCT03405662|141304603|SUPERIORITY|||||||0.68|||||||non-parametric Kolmogorov-Smirnov test|||||||0.68
70908090|NCT03405662|141304604|SUPERIORITY|||||||0.86|||||||non-parametric Kolmogorov-Smirnov test|||||||0.86
70908091|NCT03405662|141304605|SUPERIORITY|||||||0.32|||||||non-parametric Kolmogorov-Smirnov test|||||||0.32
70908092|NCT03875911|141304618|EQUIVALENCE|ANOVA was used to analyze equivalence between arms||||||0.52|||||||ANOVA|||||||0.52
70908093|NCT03875911|141304619|EQUIVALENCE|Equivalence calculated using ANOVA||||||0.01|||||||ANOVA|||||||0.01
70908094|NCT03875911|141304620|EQUIVALENCE|Equivalence was assessed using ANOVA||||||0.25|||||||ANOVA|||||||0.25
70908095|NCT03875911|141304621|EQUIVALENCE|Equivalence determined by ANOVA||||||0.93|||||||ANOVA|||||||0.93
70908096|NCT03875911|141304622|EQUIVALENCE|Equivalence determined by ANOVA||||||0.83|||||||ANOVA|||||||0.83
70908097|NCT03875911|141304623|EQUIVALENCE|Equivalence was determined using ANOVA||||||0.54|||||||ANOVA|||||||0.54
70908098|NCT05126459|141304641|SUPERIORITY|||||||0.016||||||The threshold for statistical significance was p=0.05.|ANOVA|||Null hypothesis: there is no significant difference in Musculo skeletal related sedation related events during sedation.||||0.016
70908099|NCT05126459|141304642|SUPERIORITY|||||||0.211||||||The threshold for statistical significance was p=0.05.|ANOVA|||Null hypothesis: there is no significant difference in Musculo skeletal related sedation related events at 8 hours after sedation.||||0.211
70908100|NCT05126459|141304643|SUPERIORITY|||||||0.374||||||The threshold for statistical significance was p=0.05.|ANOVA|||||||0.374
70908101|NCT05126459|141304644|SUPERIORITY|||||||0.55|||||||ANOVA|||Null hypothesis: there is no significant difference in GI reaction between the 3 regimens.||||0.55
70908102|NCT05126459|141304645|SUPERIORITY|||||||0.16||||||The threshold for statistical significance was p=0.05.|ANOVA|||Null hypothesis: there is no significant difference in GI reaction between the 3 regimens 8 hours after sedation.||||0.16
70908103|NCT05126459|141304646|SUPERIORITY|||||||0.012||||||The threshold for statistical significance was p=0.05.|ANOVA|||Null hypothesis: there is no significant difference in GI reaction between the 3 regimens at 24 hours after sedation.||||0.012
70908104|NCT00614198|141304654|SUPERIORITY_OR_OTHER||||||<|0.01||||||A priori p threshold set for stage 1 (baseline - 8m; p\<0.01) or (baseline - 12 months, p\<0.05) in order to progress to stage 2 (8 or 12 months - 20 or 24 months).|Mixed Models Analysis|||1st stage analysis (baseline-8m or 12m) used a repeated measures model for all assessment measures. Model included baseline, age, time and time\*treatment interaction. Results informed 2nd stage (8 or 12 months - 20 or 24 months). 2nd stage analysis based on various statistical scenarios (baseline vs 12 months on intervention, 12 months of no intervention vs 12 on intervention, baseline vs 24 months on intervention). No ADOS assessments were used at 12 months because of risk of practice effects.||||<0.01
70908105|NCT00065468|141304656|NON_INFERIORITY_OR_EQUIVALENCE|2 null hypotheses (Ho) were tested: 1) Survival distributions for temsirolimus alone and Interferon Alfa (IFN)-alone treatment groups were identical. 2) Survival distributions for temsirolimus in combination with IFN and IFN-alone treatment groups were identical. The alternative hypothesis (Ha) for each test was that the survival distributions differed.|Cox Proportional Hazard|0.78||||0.0252|TWO_SIDED|95.0|0.63|0.97|||Log Rank|Stratified by prior nephrectomy and region||||0.97|0.63|0.0252
70908106|NCT00065468|141304656|NON_INFERIORITY_OR_EQUIVALENCE|2 null hypotheses (Ho) were tested: 1) Survival distributions for temsirolimus alone and IFN-alone treatment groups were identical. 2) Survival distributions for temsirolimus in combination with IFN and IFN-alone treatment groups were identical. The alternative hypothesis (Ha) for each test was that the survival distributions differed.|Cox Proportional Hazard|0.93||||0.4902|TWO_SIDED|95.0|0.75|1.15|||Log Rank|Stratified by prior nephrectomy and region||||1.15|0.75|0.4902
70908107|NCT00065468|141304657|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.74||||0.0042|TWO_SIDED|95.0|0.6|0.91|||Log Rank|Stratified by prior nephrectomy and region||||0.91|0.60|0.0042
70908108|NCT00065468|141304657|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.76||||0.0107|TWO_SIDED|95.0|0.62|0.94|||Log Rank|Stratified by prior nephrectomy and region||||0.94|0.62|0.0107
70908109|NCT00065468|141304658|SUPERIORITY_OR_OTHER|||||||0.1361|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by prior nephrectomy and region||||||0.1361
70908110|NCT00065468|141304658|SUPERIORITY_OR_OTHER|||||||0.1062|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by prior nephrectomy and region||||||0.1062
70908111|NCT00065468|141304659|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by prior nephrectomy and region||||||<0.0001
70908112|NCT00065468|141304659|SUPERIORITY_OR_OTHER|||||||0.0011|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by prior nephrectomy and region||||||0.0011
70908113|NCT00065468|141304661|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.62|||<|0.0001|TWO_SIDED|95.0|0.51|0.76|||Log Rank|Stratified by prior nephrectomy and region||||0.76|0.51|<0.0001
70908114|NCT00065468|141304661|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.73||||0.002|TWO_SIDED|95.0|0.6|0.89|||Log Rank|Stratified by prior nephrectomy and region||||0.89|0.60|0.0020
70908115|NCT01225835|141304664|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||The significance level is 0.05.|t-test, 2 sided|||||||0.003
70908116|NCT01225835|141304664|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||The significance level is 0.05.|t-test, 2 sided|||Age \< 39 years||||0.015
70908117|NCT01225835|141304664|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||The significance level is 0.05.|t-test, 2 sided|||Age \>= 39 years||||0.027
70908118|NCT01225835|141304666|SUPERIORITY_OR_OTHER|||||||1||95.0||||The significance level is 0.05.|Fisher Exact|||||||1.00
70908119|NCT01225835|141304667|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)|||||||0.004
70908120|NCT01225835|141304668|SUPERIORITY_OR_OTHER|||||||0.121||95.0||||The significance level is 0.05.|t-test, 2 sided|||||||0.121
70908121|NCT01225835|141304669|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Level of significance is 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
70908122|NCT01225835|141304670|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)|||||||<0.001
70908123|NCT01225835|141304672|SUPERIORITY_OR_OTHER|||||||0.482||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)|||||||0.482
70908124|NCT01225835|141304673|SUPERIORITY_OR_OTHER|||||||0.871||||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Chi-squared|||||||0.871
70908125|NCT01225835|141304674|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)|||||||<0.001
70908126|NCT01225835|141304675|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|t-test, 2 sided|||||||0.620
70908127|NCT01225835|141304676|SUPERIORITY_OR_OTHER|||||||0.478||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|t-test, 2 sided|||||||0.478
70908128|NCT01225835|141304677|SUPERIORITY_OR_OTHER|||||||0.69||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Fisher Exact|||||||0.69
70908129|NCT01225835|141304678|SUPERIORITY_OR_OTHER|||||||0.295||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)|||||||0.295
70908130|NCT01225835|141304679|SUPERIORITY_OR_OTHER|||||||0.405||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)|||||||0.405
70908131|NCT01225835|141304680|SUPERIORITY_OR_OTHER|||||||1||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Fisher Exact|||||||1.000
70908132|NCT05515679|141304689|SUPERIORITY||Median Difference (Final Values)|0.72|STANDARD_DEVIATION|0.48|<|0.01|TWO_SIDED|95.0|0.51|0.94|||t-test, 2 sided|||Using a paired sample t-test (two tailed), we wished to examine whether there was an increase in Constructive Engagement and Pleasure and a reduction in Passive Engagement, Distracted Engagement, and Non-Engagement, from baseline to treatment. With an anticipated PWD sample of 24, and using means and standard deviations from the PI's previous studies, we calculated a power of 90% to detect effects (alpha = .05; one-tailed test). (3) PWD and staff report high satisfaction wi||.94|.51|<0.01
70908133|NCT05515679|141304690|SUPERIORITY||Mean Difference (Final Values)|-0.33|STANDARD_DEVIATION|0.6||0.017|TWO_SIDED|95.0|-0.59|-0.07|||t-test, 2 sided|||||-0.07|-0.59|.017
70908134|NCT05515679|141304691|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_DEVIATION|0.41||0.008|TWO_SIDED|95.0|-0.43|-0.07|||t-test, 2 sided|||||-0.07|-0.43|.008
70908135|NCT05515679|141304692|SUPERIORITY||Median Difference (Final Values)|-0.15|STANDARD_DEVIATION|0.34||0.053|TWO_SIDED|95.0|-0.3|0.0|||t-test, 2 sided|||||-.00|-.30|0.053
70908136|NCT05515679|141304693|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_DEVIATION|0.28|<|0.01|TWO_SIDED|95.0|0.54|0.79|||t-test, 2 sided|||||.79|.54|<.01
70908137|NCT05515679|141304694|SUPERIORITY||Mean Difference (Final Values)|4.11|STANDARD_DEVIATION|3.35|<|0.001|TWO_SIDED|95.0|2.62|5.6|||t-test, 2 sided|||||5.60|2.62|<.001
70908138|NCT05515679|141304695|SUPERIORITY||Mean Difference (Final Values)|-1.07|STANDARD_DEVIATION|1.1|<|0.001|TWO_SIDED|95.0|-1.55|-0.58|||t-test, 2 sided|||||-0.58|-1.55|<.001
70908139|NCT05515679|141304696|SUPERIORITY||Median Difference (Final Values)|6.02|STANDARD_DEVIATION|11.4||0.022|TWO_SIDED|95.0|0.97|11.1|||t-test, 2 sided|||||11.1|0.97|.022
70908140|NCT05515679|141304697|SUPERIORITY||Mean Difference (Final Values)|1.23|STANDARD_DEVIATION|9.5||0.551|TWO_SIDED|95.0|-2.9|5.44|||t-test, 2 sided|||||5.44|-2.90|.551
70908141|NCT05515679|141304698|SUPERIORITY||Mean Difference (Final Values)|27.43|STANDARD_DEVIATION|0.11|<|0.001|TWO_SIDED|95.0|17.7|37.2|||t-test, 2 sided|||||37.2|17.7|<.001
70908142|NCT01952301|141304718|NON_INFERIORITY_OR_EQUIVALENCE|The primary hypothesis of the study evaluated whether CM was not inferior to Control in the generation of KT width from baseline to 6 months. A paired t-test was used to test for non-inferiority, using a one-sided significance level of 0.05 and a non-inferiority margin of 1.0 mm.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
70908143|NCT01168674|141304742|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.57|STANDARD_DEVIATION|1.67||0.48|TWO_SIDED||||||Mixed Models Analysis||The report is of the mean MADRS difference between ziprasidone versus placebo after linear mixed regression, correcting for confounding effects of order of treatment as well as other identified potential confounders.|Linear mixed effects regression model||||0.48
70908144|NCT02584855|141304744|SUPERIORITY||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and conventional disease-modifying antirheumatic drug (cDMARD) use at the time of double blind randomization.||||<0.001
70908145|NCT02584855|141304745|SUPERIORITY||Odds Ratio (OR)|-45.6|||||TWO_SIDED|95.0|-58.8|-32.3||||||Logistic regression adjusting for treatment, geographic region, and cDMARD use at the time of double-blind randomization .||-32.3|-58.8|
70908146|NCT02584855|141304748|SUPERIORITY||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.||||<0.001
70908147|NCT02584855|141304749|SUPERIORITY||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.||||<0.001
70908148|NCT02584855|141304750|SUPERIORITY||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.||||<0.001
70908149|NCT02584855|141304751|SUPERIORITY||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.||||<0.001
70908150|NCT02584855|141304752|SUPERIORITY||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.||||<0.001
70908151|NCT02138747|141304757|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.89|STANDARD_ERROR_OF_MEAN|0.997||0.004|TWO_SIDED|95.0|-4.86|-0.93||p-value based on the ANOVA model|ANOVA|||Tolerability score was analyzed using the ANOVA model (Model #1), with sequence group, study period, period-by-sequence interaction, gender and treatment group as factors, and subject-within-sequence as a random term. p-value based on the ANOVA model. Difference used mirabegron as the reference (difference =tolterodine ER -mirabegron). A negative difference indicates better reported tolerability with mirabegron than with tolterodine ER.||-0.93|-4.86|0.004
70908152|NCT02138747|141304758|SUPERIORITY_OR_OTHER_LEGACY|||||||0.77||||||P value was obtained using Mainland-Gart test to compare the proportion of preference for each treatment group. The denominator excluded patients with No Preference.|Mainland-Gart|||Participants who selected Mirabegron or Tolterodine ER were included in the denominator and participants with No Preference were excluded. Comparison was between Mirabegron vs Tolterodine ER.||||0.77
70908153|NCT02138747|141304767|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.224||0.971|TWO_SIDED|95.0|-0.39|0.49||Adjusted P value was generated from the ANCOVA model for the period-by-treatment interaction.|ANCOVA|||Adjusted difference vs mirabegron where difference used mirabegron as the reference (difference = tolterodine ER - mirabegron).||0.49|-0.39|0.971
70908154|NCT02138747|141304768|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.199||0.211|TWO_SIDED|95.0|-0.28|0.5||Adjusted P value was generated from the ANCOVA model for the period-by-treatment interaction.|ANCOVA|||Adjusted difference vs mirabegron where difference used mirabegron as the reference (difference = tolterodine ER - mirabegron).||0.50|-0.28|0.211
70908155|NCT00932646|141304770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.139|0.205|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.205|0.139|<0.0001
70969961|NCT02873936|141445708|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|2.7||0.052|TWO_SIDED|95.0|-11.0|0.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.0|-11.0|0.052
70908156|NCT00932646|141304770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.14|0.208|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.208|0.140|<0.0001
70908157|NCT00932646|141304770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.124|0.191|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.191|0.124|<0.0001
70908158|NCT00932646|141304771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.114|0.176|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.176|0.114|<0.0001
70908159|NCT00932646|141304771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.116|0.179|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.179|0.116|<0.0001
70908160|NCT00932646|141304771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.125|0.187|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.187|0.125|<0.0001
70908161|NCT00932646|141304772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.149|0.223|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.223|0.149|<0.0001
70908162|NCT00932646|141304772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.162|0.235|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.235|0.162|<0.0001
70908163|NCT00932646|141304772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.176|0.25|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.250|0.176|<0.0001
70908164|NCT00932646|141304773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.154|0.23|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.230|0.154|<0.0001
70908165|NCT00932646|141304773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.197|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.158|0.235|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.235|0.158|<0.0001
70908166|NCT00932646|141304773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.217|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.178|0.255|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.255|0.178|<0.0001
70908167|NCT00932646|141304774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.026||0.0003||95.0|0.045|0.148|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.148|0.045|0.0003
70908168|NCT00932646|141304774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.026||0.0001||95.0|0.051|0.155|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.155|0.051|0.0001
70908169|NCT00932646|141304774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.026||0.0026||95.0|0.028|0.132|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.132|0.028|0.0026
70908170|NCT00932646|141304775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.195|0.306|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.306|0.195|<0.0001
70908171|NCT00932646|141304775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.246|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.19|0.302|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.302|0.190|<0.0001
70908172|NCT00932646|141304775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.235|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.179|0.291|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.291|0.179|<0.0001
70908173|NCT00932646|141304776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.101|0.222|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.222|0.101|<0.0001
70908174|NCT00932646|141304776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.096|0.218|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.218|0.096|<0.0001
70969962|NCT02873936|141445709|SUPERIORITY||Least Squares Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-21.0|-10.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-10.0|-21.0|<0.001
70908175|NCT00932646|141304776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.223|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.162|0.284|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.284|0.162|<0.0001
71091996|NCT03286504|141690562|SUPERIORITY||proportion difference|0.208||||0.03|TWO_SIDED|95.0|0.023|0.393|||Chi-squared||Direction of proportion difference = FANMI arm minus Standard of Care arm.|||0.393|0.023|0.03
70908176|NCT00932646|141304777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.155|0.258|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.258|0.155|<0.0001
70908177|NCT00932646|141304777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.202|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.15|0.255|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.255|0.150|<0.0001
70908178|NCT00932646|141304777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.229|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.176|0.281|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.281|0.176|<0.0001
70908179|NCT00932646|141304778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.299|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.233|0.365|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.365|0.233|<0.0001
70908180|NCT00932646|141304778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.302|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.236|0.369|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.369|0.236|<0.0001
70908181|NCT00932646|141304778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.338|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.271|0.405|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.405|0.271|<0.0001
70908182|NCT00932646|141304779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.055||0.0163||95.0|0.024|0.239|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.239|0.024|0.0163
70908183|NCT00932646|141304779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.055||0.0118||95.0|0.031|0.247|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.247|0.031|0.0118
70908184|NCT00932646|141304779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.055||0.0076||95.0|0.04|0.256|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.256|0.040|0.0076
71091997|NCT03320369|141690577|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70908185|NCT00932646|141304780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.082|0.154|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.154|0.082|<0.0001
70908186|NCT00932646|141304780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.084|0.157|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.157|0.084|<0.0001
70908187|NCT00932646|141304780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.119|0.191|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.191|0.119|<0.0001
70908188|NCT00653263|141304782|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Mixed Models Analysis|||Means and ranges were computed for the continuous baseline characteristics.For data with 5 time points (baseline and weeks 1 through 4), hypothesis tests were performed to test for a differences between baseline and each subsequent time point as well as differences between each time point For data with 3 time points hypothesis tests were performed to test for a differences between baseline and wk 2, wk 2 and wk 4, as well as between baseline and wk 4.||||<0.05
70908189|NCT00653263|141304783|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Mixed Models Analysis|||Means and ranges were computed for continuous baseline(BL)characteristics.For longitudinal data,Proc GLIMMIX in SAS was used to fit a Mixed Model with Random Intercept.For data with 5 time points, hypothesis tests were performed to test for a differences between BL and each subsequent time point as well as differences between each time point. For data with 3 time points, hypothesis tests were performed to test for a differences between BL and wk 2,wk 2and wk 4,as well as between BL and wk 4.||||<0.05
70908190|NCT00653263|141304784|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Mixed Models Analysis|||Means and ranges were computed for continuous baseline(BL)characteristics.For longitudinal data,Proc GLIMMIX in SAS was used to fit a Mixed Model with Random Intercept.For data with 5 time points, hypothesis tests were performed to test for a differences between BL and each subsequent time point as well as differences between each time point. For data with 3 time points, hypothesis tests were performed to test for a differences between BL and wk 2,wk 2and wk 4,as well as between BL and wk 4.||||<0.05
70908191|NCT03844321|141304792|SUPERIORITY||Difference in Slopes|-0.02||||0.82|TWO_SIDED|95.0|-0.24|0.19||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|df = 1607|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|We used a linear mixed effects model to examine the difference in effect of time on weekly WHO-5 scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks. This model accounts for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing assessment scores. The model includes a random slope and intercept, and fixed effects for intervention, time, and an intervention by time interaction.||0.19|-0.24|.820
70908192|NCT03844321|141304792|SUPERIORITY||Difference in Slopes|-0.08||||0.11|TWO_SIDED|95.0|-0.18|0.02||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1147|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|We used a linear mixed effects model to examine the difference in effect of time on weekly WHO-5 scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 20 weeks. This model accounts for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing assessment scores. The model includes a random slope and intercept, and fixed effects for intervention, time, and an intervention by time interaction.||0.02|-0.18|.110
71091998|NCT01732692|141690581|NON_INFERIORITY_OR_EQUIVALENCE|The primary endpoint was analyzed by a non-inferiority test using the exact Farrington-Manning method. Non-inferiority of the two treatments was to be concluded if the lower end of the confidence interval of the difference the experimental treatment group (morning-only dose) - control treatment group (split dose) was above a non-inferiority margin of -0.15%.|Treatment Difference|0.0286|||<|0.001|ONE_SIDED|95.0|-0.097||||Exact Farrington - Manning||Treatment Difference is the difference in proportion of participants with successful colon cleansing between treatments -experimental vs. control||||-0.097|<0.001
70908193|NCT03844321|141304793|SUPERIORITY||Difference in Slopes|-0.03||||0.284|TWO_SIDED|95.0|-0.07|0.02||A two-sided significance level of .05 was used.|Mixed Models Analysis|df= 1726|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PSS scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks.||0.02|-0.07|.284
70908194|NCT03844321|141304793|SUPERIORITY||Difference in Slopes|0.01||||0.394|TWO_SIDED|95.0|-0.01|0.03||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1018|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PSS scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 20 weeks.||0.03|-0.01|.394
70908195|NCT03844321|141304794|SUPERIORITY||Difference in Slopes|0.03||||0.431|TWO_SIDED|95.0|-0.04|0.09||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1591|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Emotional Distress-Depression Short Form scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks.||0.09|-0.04|.431
70908196|NCT03844321|141304794|SUPERIORITY||Difference in Slopes|0.05|||<|0.001|TWO_SIDED|95.0|0.02|0.08||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1159|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Emotional Distress-Depression Short Form scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 20 weeks.||0.08|0.02|<.001
70908197|NCT03844321|141304795|SUPERIORITY||Difference in Slopes|-0.01||||0.399|TWO_SIDED|95.0|-0.05|0.02||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1601|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Emotional Distress-Anxiety Short Form scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks.||0.02|-0.05|.399
70908198|NCT03844321|141304795|SUPERIORITY||Difference in Slopes|0.02||||0.048|TWO_SIDED|95.0|0.0|0.03||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1171|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Emotional Distress-Anxiety Short Form scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 20 weeks.||0.03|0.00|.048
70908199|NCT03844321|141304796|SUPERIORITY||Difference in Slopes|-0.02||||0.488|TWO_SIDED|95.0|-0.06|0.03||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1560|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Ability to Participate in Social Roles and Activities Short Form scores (reverse scored) in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks.||0.03|-0.06|.488
70908200|NCT03844321|141304796|SUPERIORITY||Difference in Slopes|0.01||||0.446|TWO_SIDED|95.0|-0.01|0.03||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1179|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Ability to Participate in Social Roles and Activities Short Form scores (reverse scored) in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 20 weeks.||0.03|-0.01|.446
70908201|NCT03844321|141304797|SUPERIORITY||Difference in Slopes|-0.04||||0.469|TWO_SIDED|95.0|-0.16|0.07||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1618|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly FFMQ scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks.||0.07|-0.16|.469
70908202|NCT03844321|141304797|SUPERIORITY||Difference in Slopes|-0.06||||0.033|TWO_SIDED|95.0|-0.11|-0.01||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1067|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used linear mixed effects models to examine the effect of time on weekly FFMQ scores across both intervention conditions from baseline to 20 weeks.||-0.01|-0.11|.033
70908203|NCT03844321|141304798|SUPERIORITY|||||||0.046||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Age measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.046
70908204|NCT03844321|141304798|SUPERIORITY|||||||0.275||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Age measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.275
70908205|NCT03844321|141304799|SUPERIORITY|||||||0.977||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PSS measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.977
70908206|NCT03844321|141304799|SUPERIORITY|||||||0.341||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PSS measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.341
70908207|NCT03844321|141304800|SUPERIORITY|||||||0.885||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PROMIS: EDD measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.885
70908208|NCT03844321|141304800|SUPERIORITY|||||||0.319||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PROMIS: EDD measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.319
70908209|NCT03844321|141304801|SUPERIORITY|||||||0.838||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PROMIS: EDA measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.838
70908210|NCT03844321|141304801|SUPERIORITY|||||||0.89||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PROMIS: EDA measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.890
70908211|NCT03844321|141304802|SUPERIORITY|||||||0.425||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PROMIS: APRA measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.425
70908212|NCT03844321|141304802|SUPERIORITY|||||||0.733||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PROMIS: APRA measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.733
70908213|NCT03844321|141304803|SUPERIORITY|||||||0.582||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||FFMQ measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.582
70908214|NCT03844321|141304803|SUPERIORITY|||||||0.666||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||FFMQ measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.666
70908215|NCT03844321|141304804|SUPERIORITY|||||||0.355||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Presence of psychiatric illness at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.355
70908216|NCT03844321|141304804|SUPERIORITY|||||||0.361||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Presence of psychiatric illness at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.361
70908217|NCT03844321|141304805|SUPERIORITY|||||||0.64||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Presence of medical problems at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.640
70908218|NCT03844321|141304805|SUPERIORITY|||||||0.396||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Presence of medical problems at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.396
70908219|NCT03844321|141304806|SUPERIORITY|||||||0.004||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Percentage of sessions completed was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.004
70908220|NCT03844321|141304806|SUPERIORITY|||||||0.291||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Percentage of sessions completed was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.291
70908221|NCT03844321|141304807|SUPERIORITY|||||||0.603||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Level of education was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.603
70908222|NCT03844321|141304807|SUPERIORITY|||||||0.333||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Level of education was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.333
70908223|NCT03844321|141304808|SUPERIORITY|||||||0.224||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Race was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.224
70908224|NCT03844321|141304808|SUPERIORITY|||||||0.885||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Race was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.885
70908225|NCT03844321|141304809|SUPERIORITY|||||||0.49||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Sex was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.490
70908226|NCT03844321|141304809|SUPERIORITY|||||||0.266||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Sex was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.266
70908227|NCT03844321|141304810|SUPERIORITY|||||||0.928||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Ethnicity was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.928
70908228|NCT03844321|141304810|SUPERIORITY|||||||0.307||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Ethnicity was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.307
70908229|NCT01374802|141304812|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|115.29|STANDARD_DEVIATION|19.4|||TWO_SIDED|90.0|101.36|131.13|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Faldaprevir+DRV/r : DRV/r) of Darunavir||131.13|101.36|
70908230|NCT01374802|141304813|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|87.91|STANDARD_DEVIATION|38.3|||TWO_SIDED|90.0|68.609|112.63|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Faldaprevir+DRV/r : DRV/r) of Darunavir||112.630|68.609|
70908231|NCT01374802|141304814|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|128.41|STANDARD_DEVIATION|15.6|||TWO_SIDED|90.0|115.724|142.489|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Faldaprevir+DRV/r : DRV/r) of Darunavir||142.489|115.724|
70908232|NCT02559609|141304825|SUPERIORITY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||Group A/C (contrast -1) compared to Group B/D (contrast 1) to test Aim 1||||.028
70908233|NCT02559609|141304826|SUPERIORITY|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||Group A/C (contrast -1) compared to Group B/D (contrast 1)||||.027
70908234|NCT02559609|141304827|SUPERIORITY|||||||0.66|||||||ANOVA|df = 1||Group A/B (contrast -1) was compared to Group C/D (contrast 1) to test Aim 2.||||.66
70908235|NCT02559609|141304828|SUPERIORITY|||||||0.89|||||||Regression, Cox|||Group A/B (contrast -1) compared to Group C/D (contrast 1) to test Aim 2.||||.89
70908236|NCT02559609|141304829|SUPERIORITY|||||||0.58|||||||ANOVA|df = 1||Group A/B (contrast -1) compared to Group C/D (contrast 1) to test Aim 2.||||.58
70908237|NCT02559609|141304830|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||Group A/C (contrast -1) compared to Group B/D (contrast 1) to test Aim 1.||||.024
70908238|NCT00064025|141304831|SUPERIORITY_OR_OTHER|||||||0.701|||||||Fisher Exact|||||||0.701
70908239|NCT00064025|141304832|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Paired t-test|||||||<.001
70908240|NCT00064025|141304833|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Paired t-test|||||||<.001
70908241|NCT03277378|141304834|NON_INFERIORITY|The hypothesis was tested at the 5% significance level.||||||0.0003|||||||Farrington- Manning non-inferioirty test|||"The hypothesis was formally addressed as:~H0: AB - TB ≤ -15% H1: AB - TB \> -15% where AB = permanent system qualification rate of Group 1 (AB) TB = permanent system qualification rate of Group 2 (TB)"||||0.0003
70908242|NCT03277378|141304835|OTHER|||||||0.25|||||||Chi-squared|||"The hypothesis was formally addressed as:~H0: P ≤ 60% H1: P \> 60% where P= percentage of physician prefer anatomic placement over targeted placement.~The analysis population included physicians who have performed both placement procedures. The hypothesis was tested at the 5% significance level."||||0.2500
70908243|NCT00518713|141304872|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||ANCOVA|||Analysis of covariance (ANCOVA) with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0120
70908244|NCT00518713|141304872|SUPERIORITY_OR_OTHER|||||||0.0015||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0015
70908245|NCT00518713|141304872|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||<0.0001
70908246|NCT00518713|141304873|SUPERIORITY_OR_OTHER|||||||0.0027||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0027
70908247|NCT00518713|141304873|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||<0.0001
70908248|NCT00518713|141304873|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||<0.0001
70908249|NCT00518713|141304874|SUPERIORITY_OR_OTHER|||||||0.1041||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.1041
70908250|NCT00518713|141304874|SUPERIORITY_OR_OTHER|||||||0.2207||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.2207
70908251|NCT00518713|141304874|SUPERIORITY_OR_OTHER|||||||0.0025||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0025
70908252|NCT00518713|141304875|SUPERIORITY_OR_OTHER|||||||0.1469||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.1469
70908253|NCT00518713|141304875|SUPERIORITY_OR_OTHER|||||||0.0161||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0161
70908254|NCT00518713|141304875|SUPERIORITY_OR_OTHER|||||||0.0024||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0024
70908255|NCT00518713|141304876|SUPERIORITY_OR_OTHER|||||||0.1324||95.0|||||ANCOVA|||≥ 25% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.1324
70908256|NCT00518713|141304876|SUPERIORITY_OR_OTHER|||||||0.0026||95.0|||||ANCOVA|||≥ 25% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0026
70908257|NCT00518713|141304876|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||ANCOVA|||≥ 25% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0004
70908258|NCT00518713|141304876|SUPERIORITY_OR_OTHER|||||||0.3383||95.0|||||ANCOVA|||≥ 50% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.3383
70908259|NCT00518713|141304876|SUPERIORITY_OR_OTHER|||||||0.0159||95.0|||||ANCOVA|||≥ 50% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0159
70908260|NCT00518713|141304876|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||≥ 50% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||<0.0001
70908261|NCT00518713|141304876|SUPERIORITY_OR_OTHER|||||||0.0279||95.0|||||ANCOVA|||≥ 75% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0279
70908262|NCT00518713|141304876|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||≥ 75% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0010
70908263|NCT00518713|141304876|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||≥ 75% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||<0.0001
70908264|NCT00518713|141304883|SUPERIORITY_OR_OTHER|||||||0.721||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.7210
70908265|NCT00518713|141304883|SUPERIORITY_OR_OTHER|||||||0.2505||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.2505
70908266|NCT00518713|141304883|SUPERIORITY_OR_OTHER|||||||0.0924||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0924
70908267|NCT00518713|141304884|SUPERIORITY_OR_OTHER|||||||0.0414||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0414
70908268|NCT00518713|141304884|SUPERIORITY_OR_OTHER|||||||0.0044||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0044
70908269|NCT00518713|141304884|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||<0.0001
70908270|NCT02404493|141304903|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One-sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
70908271|NCT02404493|141304903|SUPERIORITY_OR_OTHER|||||||0.023||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.023
70908272|NCT02404493|141304903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|422.81|STANDARD_ERROR_OF_MEAN|122.905||0.003|TWO_SIDED|95.0|166.435|679.186||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||679.186|166.435|0.003
70908273|NCT02404493|141304904|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
70908274|NCT02404493|141304904|SUPERIORITY_OR_OTHER|||||||0.754||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.754
70908275|NCT02404493|141304904|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|52.3|STANDARD_ERROR_OF_MEAN|19.21||0.013|TWO_SIDED|95.0|12.23|92.373||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||92.373|12.230|0.013
70908276|NCT02404493|141304905|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
70908277|NCT02404493|141304905|SUPERIORITY_OR_OTHER|||||||0.271||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.271
70908278|NCT02404493|141304905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|167.95|STANDARD_ERROR_OF_MEAN|48.21||0.002|TWO_SIDED|95.0|67.046|268.854||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||268.854|67.046|0.002
70908279|NCT02404493|141304906|SUPERIORITY_OR_OTHER|||||||0.002||||||The significance level threshold level was 0.05.|One-sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.002
70908280|NCT02404493|141304906|SUPERIORITY_OR_OTHER|||||||0.26||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.260
70908281|NCT02404493|141304906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|221.97|STANDARD_ERROR_OF_MEAN|100.674||0.04|TWO_SIDED|95.0|11.254|432.68||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||432.680|11.254|0.040
70908282|NCT02404493|141304907|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
70908283|NCT02404493|141304907|SUPERIORITY_OR_OTHER|||||||0.22||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.220
70908284|NCT02404493|141304907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|194.0|STANDARD_ERROR_OF_MEAN|68.461||0.011|TWO_SIDED|95.0|50.712|337.291||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||337.291|50.712|0.011
70908285|NCT02404493|141304908|SUPERIORITY_OR_OTHER|||||||0.002||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.002
70908286|NCT02404493|141304908|SUPERIORITY_OR_OTHER|||||||0.06||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.060
70908287|NCT02404493|141304908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|134.9|STANDARD_ERROR_OF_MEAN|79.567||0.107|TWO_SIDED|95.0|-32.266|302.063||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||302.063|-32.266|0.107
70908288|NCT02404493|141304909|SUPERIORITY_OR_OTHER|||||||0.692||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.692
70908289|NCT02404493|141304909|SUPERIORITY_OR_OTHER|||||||0.541||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.541
70908290|NCT02404493|141304909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.18||0.492|TWO_SIDED|95.0|-0.25|0.502||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.502|-0.250|0.492
70908291|NCT02404493|141304910|SUPERIORITY_OR_OTHER|||||||0.017||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.017
70908292|NCT02404493|141304910|SUPERIORITY_OR_OTHER|||||||0.223||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.223
70908293|NCT02404493|141304910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.231||0.518|TWO_SIDED|95.0|-0.635|0.331||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.331|-0.635|0.518
70908294|NCT02404493|141304911|SUPERIORITY_OR_OTHER|||||||0.005||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.005
70908295|NCT02404493|141304911|SUPERIORITY_OR_OTHER|||||||0.821||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.821
70908296|NCT02404493|141304911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.351||0.06|TWO_SIDED|95.0|-1.435|0.032||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.032|-1.435|0.060
70908297|NCT02404493|141304912|SUPERIORITY_OR_OTHER|||||||0.007||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.007
70908298|NCT02404493|141304912|SUPERIORITY_OR_OTHER|||||||0.051||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.051
70908299|NCT02404493|141304912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.188||0.926|TWO_SIDED|95.0|-0.41|0.375||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.375|-0.410|0.926
70908300|NCT02404493|141304913|SUPERIORITY_OR_OTHER|||||||0.58||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.580
70908301|NCT02404493|141304913|SUPERIORITY_OR_OTHER|||||||0.363||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.363
70908302|NCT02404493|141304913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.539|TWO_SIDED|95.0|-0.531|0.286||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.286|-0.531|0.539
70908303|NCT02404493|141304914|SUPERIORITY_OR_OTHER|||||||0.055||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.055
70908304|NCT02404493|141304914|SUPERIORITY_OR_OTHER|||||||0.076||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.076
70908305|NCT02404493|141304914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.27||0.682|TWO_SIDED|95.0|-0.672|0.449||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.449|-0.672|0.682
70908306|NCT02404493|141304915|SUPERIORITY_OR_OTHER|||||||0.004||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.004
70908307|NCT02404493|141304915|SUPERIORITY_OR_OTHER|||||||0.025||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.025
70908308|NCT02404493|141304915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.24||0.991|TWO_SIDED|95.0|-0.509|0.514||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.514|-0.509|0.991
70908309|NCT02404493|141304916|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
70908310|NCT02404493|141304916|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
70908311|NCT02404493|141304916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.19||0.334|TWO_SIDED|95.0|-0.214|0.6||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.600|-0.214|0.334
70908312|NCT02404493|141304917|SUPERIORITY_OR_OTHER|||||||0.169||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.169
70908313|NCT02404493|141304917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.24||0.317|TWO_SIDED|95.0|-0.778|0.278||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.278|-0.778|0.317
70908314|NCT02404493|141304918|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
70908315|NCT02404493|141304918|SUPERIORITY_OR_OTHER|||||||0.182||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.182
70908316|NCT02404493|141304918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.027|TWO_SIDED|95.0|-0.931|-0.069||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.069|-0.931|0.027
70908317|NCT02404493|141304919|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
70908318|NCT02404493|141304919|SUPERIORITY_OR_OTHER|||||||0.08||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.080
70908319|NCT02404493|141304919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.31||0.699|TWO_SIDED|95.0|-0.824|0.574||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.574|-0.824|0.699
70908320|NCT02404493|141304920|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
70908321|NCT02404493|141304920|SUPERIORITY_OR_OTHER|||||||0.058||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.058
70908322|NCT02404493|141304920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.33||0.711|TWO_SIDED|95.0|-0.607|0.857||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.857|-0.607|0.711
70908323|NCT02404493|141304921|SUPERIORITY_OR_OTHER|||||||0.006||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.006
70908324|NCT02404493|141304921|SUPERIORITY_OR_OTHER|||||||0.012||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.012
70908325|NCT02404493|141304921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.194||0.932|TWO_SIDED|95.0|-0.391|0.424||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.424|-0.391|0.932
70908326|NCT02404493|141304922|SUPERIORITY_OR_OTHER|||||||0.003||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.003
70908327|NCT02404493|141304922|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
70908328|NCT02404493|141304922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.228||0.767|TWO_SIDED|95.0|-0.41|0.547||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.547|-0.410|0.767
70908329|NCT02404493|141304923|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
70908330|NCT02404493|141304923|SUPERIORITY_OR_OTHER|||||||0.004||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.004
70908331|NCT02404493|141304923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.242||0.571|TWO_SIDED|95.0|-0.65|0.37||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.370|-0.650|0.571
70908332|NCT01216293|141305041|SUPERIORITY_OR_OTHER_LEGACY||Difference|19.2|||||TWO_SIDED|95.0|7.0|30.2|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||30.2|7.0|
70908333|NCT01216293|141305041|SUPERIORITY_OR_OTHER_LEGACY||Difference|18.2|||||TWO_SIDED|95.0|6.7|30.4|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||30.4|6.7|
70908334|NCT01216293|141305042|SUPERIORITY_OR_OTHER_LEGACY||Difference|27.366|||||TWO_SIDED|95.0|12.749|42.957|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||42.957|12.749|
70908335|NCT01216293|141305042|SUPERIORITY_OR_OTHER_LEGACY||Difference|22.025|||||TWO_SIDED|95.0|8.357|35.714|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||35.714|8.357|
70908336|NCT01216293|141305043|SUPERIORITY_OR_OTHER_LEGACY||Difference|20.1|||||TWO_SIDED|95.0|4.0|34.4|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||34.4|4.0|
70908337|NCT01216293|141305043|SUPERIORITY_OR_OTHER_LEGACY||Difference|11.6|||||TWO_SIDED|95.0|-2.7|28.3|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||28.3|-2.7|
70908338|NCT01216293|141305044|SUPERIORITY_OR_OTHER_LEGACY||Difference|6.83|||||TWO_SIDED|95.0|0.4|12.78|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||12.78|0.40|
70908339|NCT01216293|141305044|SUPERIORITY_OR_OTHER_LEGACY||Difference|7.23|||||TWO_SIDED|95.0|0.59|12.86|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||12.86|0.59|
70908340|NCT05454449|141305107|OTHER|||||||0.047|||||||t-test, 2 sided|||||||0.047
70908341|NCT05454449|141305108|OTHER|||||||0.009|||||||t-test, 2 sided|||||||0.009
70908342|NCT05454449|141305109|OTHER|||||||0.082|||||||t-test, 2 sided|||||||0.082
70908343|NCT05454449|141305110|OTHER|||||||0.022|||||||t-test, 2 sided|||||||0.022
70908344|NCT05454449|141305111|OTHER|||||||0.016|||||||t-test, 2 sided|||||||0.016
70908345|NCT05454449|141305112|OTHER|||||||0.029|||||||t-test, 2 sided|||||||0.029
70908346|NCT05454449|141305113|OTHER|||||||0.007|||||||t-test, 2 sided|||||||0.007
70908347|NCT03748979|141305137|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 1.|Mixed Model for Repeated Measures (MMRM)|||||||<0.0001
70908348|NCT03748979|141305137|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 1.|MMRM|||||||<0.0001
70908349|NCT03748979|141305137|SUPERIORITY|||||||0.0002||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 7.|MMRM|||||||0.0002
70908350|NCT03748979|141305137|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 7.|MMRM|||||||<0.0001
70908351|NCT03748979|141305137|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 1.|MMRM|||||||<0.0001
70908352|NCT03748979|141305137|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 1.|MMRM|||||||<0.0001
70908353|NCT03748979|141305137|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 7.|MMRM|||||||<0.0001
70908354|NCT03748979|141305137|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 7.|MMRM|||||||<0.0001
70908355|NCT03249376|141305142|SUPERIORITY||Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|0.89|<|0.0001|TWO_SIDED|95.0|-6.34|-2.83|||Mixed Effects Model for Repeated Measure|||||-2.83|-6.34|<0.0001
70908356|NCT03249376|141305143|SUPERIORITY||Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.37|-0.51|||Mixed Effects Model for Repeated Measure|||||-0.51|-1.37|<0.0001
70908357|NCT03249376|141305144|SUPERIORITY||Least Squares Mean Difference|4.6||||0.005|TWO_SIDED|95.0|1.42|7.69|||ANCOVA|||||7.69|1.42|0.005
70908358|NCT01154036|141305145|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-12.7|||<|0.001|TWO_SIDED|95.0|-16.6|-8.7||The primary hypotheses were tested at 0.045, applying Hochberg's procedure.|Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-8.7|-16.6|<0.001
70908359|NCT01154036|141305145|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimate|-9.1|||<|0.001|TWO_SIDED|95.0|-12.9|-5.4||The primary hypotheses were tested at 0.045, applying Hochberg's procedure.|Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-5.4|-12.9|<0.001
70908360|NCT01154036|141305146|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-10.5|||<|0.001|TWO_SIDED|95.0|-15.9|-5.1||The secondary hypotheses were tested at an adaptive alpha level depending on the hypotheses testing result of the primary hypotheses.|Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-5.1|-15.9|<0.001
70908361|NCT01154036|141305146|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-9.5|||<|0.001|TWO_SIDED|95.0|-13.6|-5.5||The secondary hypotheses were tested at an adaptive alpha level depending on the hypotheses testing result of the primary hypotheses.|Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-5.5|-13.6|<0.001
70908362|NCT01154036|141305147|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.51|||<|0.001|TWO_SIDED|95.0|1.62|3.89|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||3.89|1.62|<0.001
70908363|NCT01154036|141305147|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.77||||0.007|TWO_SIDED|95.0|1.17|2.67|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||2.67|1.17|0.007
70908364|NCT01154036|141305148|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.71|||<|0.001|TWO_SIDED|95.0|1.55|4.73|||Logistic regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||4.73|1.55|<0.001
70908365|NCT01154036|141305148|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.38|||<|0.001|TWO_SIDED|95.0|1.56|3.63|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||3.63|1.56|<0.001
70908366|NCT01154036|141305149|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|9.46|||<|0.001|TWO_SIDED|95.0|4.56|19.62|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||19.62|4.56|<0.001
70908367|NCT01154036|141305149|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.9|||<|0.001|TWO_SIDED|95.0|2.23|6.82|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||6.82|2.23|<0.001
70908368|NCT01154036|141305150|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|27.77||||0.001|TWO_SIDED|95.0|3.64|211.83|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||211.83|3.64|0.001
70908369|NCT01154036|141305150|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|7.08|||<|0.001|TWO_SIDED|95.0|2.85|17.56|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||17.56|2.85|<0.001
70908370|NCT01154036|141305151|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-7.1|||<|0.001|TWO_SIDED|95.0|-9.7|-4.4|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.4|-9.7|<0.001
70908371|NCT01154036|141305151|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-5.8|||<|0.001|TWO_SIDED|95.0|-8.3|-3.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-3.3|-8.3|<0.001
70908372|NCT01154036|141305152|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-6.8|||<|0.001|TWO_SIDED|95.0|-10.7|-3.0|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-3.0|-10.7|<0.001
70908373|NCT01154036|141305152|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-7.4|||<|0.001|TWO_SIDED|95.0|-10.2|-4.5|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.5|-10.2|<0.001
70908374|NCT01154036|141305153|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-2.1||||0.466|TWO_SIDED|95.0|-7.8|3.5|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||3.5|-7.8|0.466
70908375|NCT01154036|141305153|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares means|-4.9||||0.081|TWO_SIDED|95.0|-10.3|0.5|||Constrained Longitudinal Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||0.5|-10.3|0.081
70908376|NCT01154036|141305154|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-2.8||||0.466|TWO_SIDED|95.0|-10.2|4.7|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||4.7|-10.2|0.466
70908377|NCT01154036|141305154|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squarres Means|-7.1||||0.011|TWO_SIDED|95.0|-12.6|-1.6|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||-1.6|-12.6|0.011
70908378|NCT01154036|141305155|SUPERIORITY_OR_OTHER_LEGACY||Difference in M--estimates|1.7||||0.133|TWO_SIDED|95.0|-0.5|4.0|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||4.0|-0.5|0.133
70908379|NCT01154036|141305155|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-0.6||||0.61|TWO_SIDED|95.0|-2.7|1.6|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||1.6|-2.7|0.610
70908380|NCT01154036|141305156|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-1.0||||0.52|TWO_SIDED|95.0|-4.2|2.1|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||2.1|-4.2|0.520
70908381|NCT01154036|141305156|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-0.7||||0.567|TWO_SIDED|95.0|-3.1|1.7|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||1.7|-3.1|0.567
70908382|NCT01154036|141305157|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-5.3||||0.003|TWO_SIDED|95.0|-8.8|-1.8|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-1.8|-8.8|0.003
70908383|NCT01154036|141305157|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-4.3||||0.011|TWO_SIDED|95.0|-7.7|-1.0|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-1.0|-7.7|0.011
70908384|NCT01154036|141305158|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-4.3||||0.079|TWO_SIDED|95.0|-9.2|0.5|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||0.5|-9.2|0.079
71091999|NCT02030600|141690587|SUPERIORITY_OR_OTHER||Treatment ratio|0.7|||<|0.0001|TWO_SIDED|95.0|0.61|0.8|||Poisson||Superiority was considered confirmed if the 95% confidence interval for the rate ratio (IDeg/IGlar) was entirely below 1.0.|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 1: Primary analysis: Number of treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the maintenance period"||0.80|0.61|<0.0001
70908385|NCT01154036|141305158|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-7.7|||<|0.001|TWO_SIDED|95.0|-11.4|-4.1|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.1|-11.4|<0.001
70908386|NCT01154036|141305159|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|1.6||||0.156|TWO_SIDED|95.0|-0.6|3.8|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||3.8|-0.6|0.156
70908387|NCT01154036|141305159|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-0.9||||0.425|TWO_SIDED|95.0|-2.9|1.2|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||1.2|-2.9|0.425
70908388|NCT01154036|141305160|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|0.5||||0.739|TWO_SIDED|95.0|-2.5|3.6|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||3.6|-2.5|0.739
70908389|NCT01154036|141305160|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-1.0||||0.41|TWO_SIDED|95.0|-3.3|1.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||1.3|-3.3|0.410
70908390|NCT01154036|141305161|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-10.1|||<|0.001|TWO_SIDED|95.0|-13.6|-6.6|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-6.6|-13.6|<0.001
70908391|NCT01154036|141305161|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-7.6|||<|0.001|TWO_SIDED|95.0|-10.9|-4.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.3|-10.9|<0.001
70908392|NCT01154036|141305162|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-9.3|||<|0.001|TWO_SIDED|95.0|-14.0|-4.5|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.5|-14.0|<0.001
70908393|NCT01154036|141305162|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-9.8||||0.001|TWO_SIDED|95.0|-13.5|-6.2|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-6.2|-13.5|0.001
70908394|NCT01154036|141305163|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-8.1|||<|0.001|TWO_SIDED|95.0|-11.2|-4.9|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.9|-11.2|<0.001
70908395|NCT01154036|141305163|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-4.8||||0.001|TWO_SIDED|95.0|-7.8|-1.9|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-1.9|-7.8|0.001
70908396|NCT01154036|141305164|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-6.9|||<|0.001|TWO_SIDED|95.0|-11.0|-2.8|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-2.8|-11.0|<0.001
70908397|NCT01154036|141305164|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-6.4|||<|0.001|TWO_SIDED|95.0|-9.4|-3.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-3.3|-9.4|<0.001
70908398|NCT01154036|141305165|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-13.7|||<|0.001|TWO_SIDED|95.0|-18.1|-9.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-9.3|-18.1|<0.001
70908399|NCT01154036|141305165|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-7.8|||<|0.001|TWO_SIDED|95.0|-11.9|-3.6|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-3.6|-11.9|<0.001
70908400|NCT01154036|141305166|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-10.4|||<|0.001|TWO_SIDED|95.0|-15.8|-4.9|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.9|-15.8|<0.001
70908401|NCT01154036|141305166|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-8.3|||<|0.001|TWO_SIDED|95.0|-12.5|-4.2|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.2|-12.5|<0.001
70908402|NCT01154036|141305167|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-6.3|||<|0.001|TWO_SIDED|95.0|-10.0|-2.5|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-2.5|-10.0|<0.001
70908403|NCT01154036|141305167|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-3.5||||0.052|TWO_SIDED|95.0|-7.1|0.0|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||0.0|-7.1|0.052
70908404|NCT01154036|141305168|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-5.8||||0.024|TWO_SIDED|95.0|-10.8|-0.8|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-0.8|-10.8|0.024
71092000|NCT02030600|141690588|SUPERIORITY_OR_OTHER||Treatment ratio|0.58|||<|0.0001|TWO_SIDED|95.0|0.46|0.74|||Poisson||Superiority was considered confirmed if the 95% confidence interval for the rate ratio (IDeg/IGlar) was entirely below 1.0.|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 2: Number of treatment-emergent severe or BG confirmed symptomatic nocturnal hypoglycaemic episodes during the maintenance period."||0.74|0.46|<0.0001
70908405|NCT01154036|141305168|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-6.1||||0.002|TWO_SIDED|95.0|-9.9|-2.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-2.3|-9.9|0.002
70908406|NCT01154036|141305169|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-10.6|||<|0.001|TWO_SIDED|95.0|-14.9|-6.4|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-6.4|-14.9|<0.001
70908407|NCT01154036|141305169|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-6.2||||0.002|TWO_SIDED|95.0|-10.2|-2.2|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-2.2|-10.2|0.002
70908408|NCT01154036|141305170|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-9.3|||<|0.001|TWO_SIDED|95.0|-14.8|-3.9|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-3.9|-14.8|<0.001
71092001|NCT02030600|141690589|SUPERIORITY_OR_OTHER|||||||0.3458||||||Superiority was confirmed if the p-value was less than 0.025.|McNemar|||"Stepwise hierarchical testing procedure:~Step 3: Proportion of subjects with one or more severe hypoglycaemic episodes in the maintenance period."||||0.3458
70908409|NCT01154036|141305170|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-8.4|||<|0.001|TWO_SIDED|95.0|-12.6|-4.2|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.2|-12.6|<0.001
70908410|NCT01154036|141305171|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-3.9||||0.613|TWO_SIDED|95.0|-18.9|11.1|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||11.1|-18.9|0.613
70908411|NCT01154036|141305171|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-1.5||||0.831|TWO_SIDED|95.0|-15.7|12.6|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||12.6|-15.7|0.831
70908412|NCT01154036|141305172|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-13.1||||0.187|TWO_SIDED|95.0|-32.6|6.4|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||6.4|-32.6|0.187
70908413|NCT01154036|141305172|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-11.6||||0.153|TWO_SIDED|95.0|-27.7|4.4|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||4.4|-27.7|0.153
70908414|NCT03226457|141305189|OTHER|Details of the power calculation are published in the Circulation, DOI: 10.1161/CIRCULATIONAHA.120.048739|||||=|0.005||||||(calculated)|ANCOVA|||"Details on the statistical analysis are published in the Circulation, DOI: 10.1161/CIRCULATIONAHA.120.048739~Analyses were performed on the primary and secondary measures comparing empagliflozin versus placebo and assessed by 2-way analysis of covariance correcting for treatment order, baseline value, and any percentage change in furosemide dose at the visit. Data for continuous outcome measures were assessed for normality before analysis."||||= 0.005
70908415|NCT04102540|141305219|OTHER|In this analysis, our null hypothesis was that the median CD4 count at baseline/exposure 1 was exactly equivalent to the median CD4 count following exposure 2 to the intervention.|Median Difference (Net)|57.39||||0.283|TWO_SIDED|95.0|-48.9|163.7||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median CD4 count between baseline/exposure 1 and exposure 2.|Statistical analysis of CD4 count between baseline/exposure 1 and exposure 2 to the intervention.||163.7|-48.9|0.283
70908416|NCT04102540|141305219|OTHER|In this analysis, our null hypothesis was that the median CD4 count at baseline/exposure 1 was exactly equivalent to the median CD4 count following the exposure 3 to the intervention.|Median Difference (Net)|60.83||||0.1823|TWO_SIDED|95.0|-29.5|151.2||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile regression|Random intercepts for subjects were included in the model.|This is the difference in median CD4 count between baseline/exposure 1 and exposure 3.|Statistical analysis of CD4 count between baseline/exposure 1 and exposure 3 to the intervention.||151.2|-29.5|0.1823
70908417|NCT04102540|141305220|OTHER|In this analysis, our null hypothesis was that the median viral load at baseline/exposure 1 was exactly equivalent to the median viral load following exposure 2 to the intervention.|Median Difference (Net)|-42.0||||0.7795|TWO_SIDED|95.0|-339.8|255.8||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression||This is the difference in median viral load between baseline/exposure 1 and exposure 2.|Statistical analysis of viral load between baseline/exposure 1 and exposure 2 to the intervention.||255.8|-339.8|0.7795
70908418|NCT04102540|141305220|OTHER|In this analysis, our null hypothesis was that the median viral load at baseline/exposure 1 was exactly equivalent to the median viral load following exposure 3 to the intervention.|Median Difference (Net)|-63.0||||0.5971|TWO_SIDED|95.0|-296.1|170.1||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|||Statistical analysis of viral load between baseline/exposure 1 and exposure 3 to the intervention.|This is the difference in median viral load between baseline/exposure 1 and exposure 3.|170.1|-296.1|0.5971
70908419|NCT04102540|141305221|OTHER|In this analysis, our null hypothesis was that the median HIV-related knowledge score at baseline/exposure 1 was exactly equivalent to the median HIV-related knowledge score following exposure 2 to the intervention.|Median Difference (Net)|2.12|||<|0.0001|TWO_SIDED|95.0|1.2|3.0||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median HIV-Related knowledge scores between baseline/exposure 1 and exposure 2.|Statistical analysis of HIV-related knowledge scores between baseline/exposure 1 and exposure 2 to the intervention.||3.0|1.2|<.0001
70908420|NCT04102540|141305221|OTHER|In this analysis, our null hypothesis was that the median HIV-related knowledge score at baseline/exposure 1 was exactly equivalent to the median HIV-related knowledge score following exposure 3 to the intervention.|Median Difference (Net)|2.0|||<|0.0001|TWO_SIDED|95.0|1.2|2.8||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median HIV-related knowledge score between baseline/exposure 1 and exposure 3.|Statistical analysis of HIV-related knowledge scores between baseline/exposure 1 and exposure 3 to the intervention.||2.8|1.2|<.0001
70908421|NCT04102540|141305223|OTHER|In this analysis, our null hypothesis was that the median self-efficacy to manage HIV scale score at baseline/exposure 1 was exactly equivalent to the median self-efficacy to manage HIV scale score following exposure 2 to the intervention.|Median Difference (Net)|0.01||||0.9879|TWO_SIDED|95.0|-0.7|0.7||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median self-efficacy to manage HIV scale scores between baseline/exposure 1 and exposure 2.|Statistical analysis of self-efficacy to manage HIV scale score between baseline/exposure 1 and exposure 2 to the intervention.||0.7|-0.7|0.9879
70908422|NCT04102540|141305223|OTHER|In this analysis, our null hypothesis was that the median self-efficacy to manage HIV scale score at baseline/exposure 1 was exactly equivalent to the median self-efficacy to manage HIV scale score following exposure 3 to the intervention.|Median Difference (Net)|0.57||||0.155|TWO_SIDED|95.0|-0.2|1.4||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median self-efficacy to manage HIV scale scores between baseline/exposure 1 and exposure 3.|Statistical analysis of self-efficacy to manage HIV scale score between baseline/exposure 1 and exposure 3 to the intervention.||1.4|-0.2|0.1550
70908423|NCT04102540|141305224|OTHER|In this model, the null hypothesis was that the odds of being non-adherent at baseline/exposure 1 were exactly equal to the odds of being non-adherent at exposure 2 giving an odds ratio of one for the null hypothesis.|Odds Ratio (OR)|1.17||||0.819|TWO_SIDED|95.0|0.3|4.52||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Regression, Logistic|This model included random effects for subjects.|In this model, the odds ratio estimate is for the odds of being non-adherent at exposure 2 relative to the odds of being non-adherent at baseline/exposure 1.|"For analysis, we dichotomized participants adherence as adherent or non-adherent."||4.52|0.30|0.8190
70969963|NCT02873936|141445709|SUPERIORITY||Least Squares Mean Difference|-14.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-19.0|-8.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.0|-19.0|<0.001
70908424|NCT04102540|141305224|OTHER|In this model, the null hypothesis was that the odds of being non-adherent at baseline/exposure 1 were exactly equal to the odds of being non-adherent at exposure 3 giving an odds ratio of one for the null hypothesis.|Odds Ratio (OR)|0.3||||0.1332|TWO_SIDED|95.0|0.07|1.43||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Regression, Logistic|This model included random effects for subjects.|In this model, the odds ratio estimate is for the odds of being non-adherent at exposure 3 relative to the odds of being non-adherent at baseline/exposure 1.|"For analysis, we dichotomized participants adherence as adherent or non-adherent."||1.43|0.07|0.1332
70908425|NCT04102540|141305225|OTHER|In this model, the null hypothesis was that the odds of good health at baseline/exposure 1 were exactly equal to the odds of good health at exposure 2 giving an odds ratio of one for the null hypothesis.|Odds Ratio (OR)|1.77||||0.316|TWO_SIDED|95.0|0.57|5.46||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Regression, Logistic|This model included random effects for subjects.|This is the estimated odds ratio of having good health at exposure 2 relative to baseline/exposure 1.|"For analysis, we dichotomized participants' responses into the following categories: good vs bad health, where good included participant responses: excellent, very good, good, and bad included the participant responses: more or less and bad."||5.46|0.57|0.3160
70908426|NCT04102540|141305225|OTHER|In this model, the null hypothesis was that the odds of having good health at baseline/exposure 1 were exactly equal to the odds of having good health at exposure 3 giving an odds ratio of one for the null hypothesis.|Odds Ratio (OR)|1.12||||0.8609|TWO_SIDED|95.0|0.32|3.93||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Regression, Logistic|This model included random effects for subjects.|This is the estimated odds ratio of having good health at exposure 3 relative to baseline/exposure 1.|"For analysis, we dichotomized participants' responses into the following categories: good vs bad health, where good included participant responses: excellent, very good, good, and bad included the participant responses: more or less and bad."||3.93|0.32|0.8609
70908427|NCT04102540|141305226|OTHER|In this analysis, our null hypothesis was that the median current health status at baseline/exposure 1 was exactly equivalent to the median current health status following exposure 2 to the intervention.|Median Difference (Net)|9.13||||0.0572|TWO_SIDED|95.0|-0.3|18.6||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median current health status between baseline/exposure 1 and exposure 2.|Statistical analysis of current health status between baseline/exposure 1 and exposure 2 to the intervention.||18.6|-0.3|0.0572
70908428|NCT04102540|141305226|OTHER|In this analysis, our null hypothesis was that the median current health status at baseline/exposure 1 was exactly equivalent to the median current health status following exposure 3 to the intervention.|Median Difference (Net)|13.1||||0.0332|TWO_SIDED|95.0|1.1|25.1||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median current health status between baseline/exposure 1 and exposure 3.|Statistical analysis of self-efficacy to manage HIV scale score between baseline/exposure 1 and exposure 3 to the intervention.||25.1|1.1|0.0332
70908429|NCT01744496|141305231|SUPERIORITY_OR_OTHER||Least Square Mean|-0.76|STANDARD_ERROR_OF_MEAN|0.55||0.172|TWO_SIDED|95.0|-1.87|0.34|||ANCOVA|ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.||||0.34|-1.87|0.172
70908430|NCT01744496|141305233|SUPERIORITY_OR_OTHER||Least Square Mean|-8.01|STANDARD_ERROR_OF_MEAN|3.77||0.038|TWO_SIDED|95.0|-15.56|-0.46|||ANCOVA|ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.||||-0.46|-15.56|0.038
70908431|NCT01744496|141305234|SUPERIORITY_OR_OTHER||Least Square Mean|-1.02|STANDARD_ERROR_OF_MEAN|0.87||0.247|TWO_SIDED|95.0|-2.76|0.73|||ANCOVA|ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.||||0.73|-2.76|0.247
70908432|NCT01744496|141305235|SUPERIORITY_OR_OTHER||Least Square Mean|-0.58|STANDARD_ERROR_OF_MEAN|0.64||0.371|TWO_SIDED|95.0|-1.85|0.7|||ANCOVA|ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.||||0.70|-1.85|0.371
70908433|NCT01744496|141305236|SUPERIORITY_OR_OTHER||Least Square Mean|-2.82|STANDARD_ERROR_OF_MEAN|2.97||0.346|TWO_SIDED|95.0|-8.76|3.13|||ANCOVA|ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.||||3.13|-8.76|0.346
70908434|NCT01567163|141305239|SUPERIORITY_OR_OTHER||Ratio geometric least squares (LS) means|0.97|||||TWO_SIDED|90.0|0.84|1.1|||Mixed Models Analysis||The ratio of geometric LS means was calculated using a mixed effect model adjusted for cycle, participant and random error. Ratio of geometric LS means is AUC(0-∞) of Cycle 2/Cycle 1.|||1.10|0.84|
70908435|NCT01567163|141305241|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|1.14|||||TWO_SIDED|90.0|0.84|1.55|||Mixed Models Analysis||The ratio of geometric least squares means was calculated using a mixed effect model adjusted for cycle, participant and random error. Ratio of Geo LS mean is Cmax of Cycle 2/Cycle 1.|||1.55|0.84|
70908436|NCT01009047|141305281|SUPERIORITY_OR_OTHER||Least-squares (LS) mean difference|0.1|STANDARD_ERROR_OF_MEAN|1.83||0.935|TWO_SIDED|95.0|-3.46|3.76||Analysis of covariance (ANCOVA) model with treatment (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||3.76|-3.46|0.935
70908437|NCT01009047|141305282|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|2.2||0.877|TWO_SIDED|95.0|-4.68|4.0||Analysis of covariance (ANCOVA) model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||4.00|-4.68|0.877
70908438|NCT01009047|141305283|SUPERIORITY_OR_OTHER||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.54||0.341|TWO_SIDED|95.0|-0.55|1.59||Day 56: Analysis of covariance (ANCOVA) model with treatment (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||1.59|-0.55|0.341
70908439|NCT01009047|141305283|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.66||0.723|TWO_SIDED|95.0|-1.06|1.53||Day 182: Analysis of covariance (ANCOVA) model with treatment (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||1.53|-1.06|0.723
70908440|NCT01009047|141305284|SUPERIORITY_OR_OTHER|||||||0.351||||||Change at Day 56: Positive Symptoms - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate.|ANCOVA|||||||0.351
70908441|NCT01009047|141305284|SUPERIORITY_OR_OTHER|||||||0.691||||||Change at Day 182:Positive Symptoms - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||||0.691
70908442|NCT01009047|141305284|SUPERIORITY_OR_OTHER|||||||0.965||||||Change at Day 56: Disorganized thoughts - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||||0.965
70908443|NCT01009047|141305284|SUPERIORITY_OR_OTHER|||||||0.766||||||Change at Day 182: Disorganized thoughts - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||||0.766
70908444|NCT01009047|141305284|SUPERIORITY_OR_OTHER|||||||0.984||||||Change at Day 56: Uncontrolled hostility/ excitement - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||||0.984
70908445|NCT01009047|141305284|SUPERIORITY_OR_OTHER|||||||0.985||||||Change at Day 182: Uncontrolled Hositility/ Excitement - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||||0.985
70908446|NCT01009047|141305284|SUPERIORITY_OR_OTHER|||||||0.803||||||Change at Day 56: Anxiety/ depression - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate.|ANCOVA|||||||0.803
70908447|NCT01009047|141305284|SUPERIORITY_OR_OTHER|||||||0.745||||||Change at Day 182: Anxiety/ depression - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate.|ANCOVA|||||||0.745
70908448|NCT01009047|141305286|SUPERIORITY_OR_OTHER|||||||0.296||||||Generalized Cochran- Mantel- Haenszel test for row mean score differences controlling for country was used.|Cochran-Mantel-Haenszel|||||||0.296
71153599|NCT03085797|141799598|OTHER||Difference in Medians|-3.18||||0.003|TWO_SIDED|95.0|-4.1|-2.26||p-Value was based on Wilcoxon rank-sum test and is adjusted for multiplicity.|Wilcoxon rank-sum test||Quantile regression with covariates: treatment, region, Baseline score, Baseline BEC. Par. with nasal surgery prior to Wks 49-52/withdrew early with no nasal surgery assigned their worst observed 4-wk mean prior to nasal surgery/study withdrawal.|||-2.26|-4.10|0.003
71153600|NCT03085797|141799599|OTHER||Difference in Medians|-16.49||||0.003|TWO_SIDED|95.0|-23.57|-9.42||p-Value was based on Wilcoxon rank-sum test and is adjusted for multiplicity.|Wilcoxon rank-sum test||Quantile regression with covariates: treatment, region, Baseline score, Baseline BEC. Par. with nasal surgery prior to Wk 52/withdrew early with no nasal surgery assigned their worst observed score prior to nasal surgery/study withdrawal.|||-9.42|-23.57|0.003
70908449|NCT01009047|141305287|SUPERIORITY_OR_OTHER|||||||0.843||||||Change at Day 56: ANCOVA model on ranks with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value (unranked) as a covariate was used.|ANCOVA|||||||0.843
70908450|NCT01009047|141305287|SUPERIORITY_OR_OTHER|||||||0.914||||||Change at Day 182: ANCOVA model on ranks with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value (unranked) as a covariate was used.|ANCOVA|||||||0.914
70908451|NCT01009047|141305288|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|1.27||0.895|TWO_SIDED|95.0|-2.34|2.67||Change at Day 56: Analysis of covariance (ANCOVA) model with treatment groups(paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||2.67|-2.34|0.895
70908452|NCT01009047|141305288|SUPERIORITY_OR_OTHER||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|1.66||0.705|TWO_SIDED|95.0|-2.64|3.89||Change at Day 182: Analysis of covariance (ANCOVA) model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||3.89|-2.64|0.705
70908453|NCT01009047|141305289|SUPERIORITY_OR_OTHER|||||||0.119||||||Day 56: Generalized Cochran-Mantel-Haenszel test for row mean score differences was used.|Cochran-Mantel-Haenszel|||||||0.119
70908454|NCT01009047|141305289|SUPERIORITY_OR_OTHER|||||||0.444||||||Day 182: Generalized Cochran-Mantel-Haenszel test for row mean score differences was used.|Cochran-Mantel-Haenszel|||||||0.444
70908455|NCT01558674|141305315|SUPERIORITY_OR_OTHER||Difference in Least Squares (LS) Means|-98.5|||||TWO_SIDED|95.0|-138.0|-59.1|||Linear mixed effect model||8-mg MK-7145 LS Mean minus Furosemide LS Mean|||-59.1|-138.0|
70908456|NCT01558674|141305317|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (GMR)|1.1|||||TWO_SIDED|90.0|0.99|1.22|||Mixed Linear Effects Model||GMR = Geometric mean (GM) MK-7145 8 mg divided by GM Furosemide|||1.22|0.99|
70908457|NCT04147260|141305329|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.068|||TWO_SIDED|90.0|-0.03|0.2|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.20|-0.03|
70908458|NCT04147260|141305329|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.067|||TWO_SIDED|90.0|-0.07|0.16|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.16|-0.07|
70908459|NCT04147260|141305329|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.055||0.572|TWO_SIDED|90.0|-0.14|0.08||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.08|-0.14|0.572
70908460|NCT04147260|141305329|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.075||0.315|TWO_SIDED|90.0|-0.07|0.23||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.23|-0.07|0.315
70908461|NCT04147260|141305329|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.059||0.286|TWO_SIDED|90.0|-0.18|0.05||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.05|-0.18|0.286
70908462|NCT04147260|141305329|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.077||0.057|TWO_SIDED|90.0|0.0|0.31||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.31|0.00|0.057
70908463|NCT04147260|141305330|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.153|||TWO_SIDED|90.0|-0.02|0.49|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.49|-0.02|
70908464|NCT04147260|141305330|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.124|||TWO_SIDED|90.0|-0.2|0.22|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.22|-0.20|
70908465|NCT04147260|141305330|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.102|<|0.001|TWO_SIDED|90.0|-0.72|-0.31||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||-0.31|-0.72|<0.001
70908466|NCT04147260|141305330|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.138|<|0.001|TWO_SIDED|90.0|0.24|0.8||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.80|0.24|<0.001
70908467|NCT04147260|141305330|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.132||0.01|TWO_SIDED|90.0|-0.62|-0.09||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||-0.09|-0.62|0.010
70908468|NCT04147260|141305330|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.173||0.001|TWO_SIDED|90.0|0.24|0.93||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.93|0.24|0.001
70908469|NCT04147260|141305331|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.044|||TWO_SIDED|90.0|-0.05|0.1|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.10|-0.05|
70908470|NCT04147260|141305331|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.038||0.998|TWO_SIDED|90.0|-0.08|0.08||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.08|-0.08|0.998
70908471|NCT04147260|141305331|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.618|TWO_SIDED|90.0|-0.08|0.13||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.13|-0.08|0.618
70908472|NCT04147260|141305331|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.099|||TWO_SIDED|90.0|-0.1|0.23|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.23|-0.10|
70908473|NCT04147260|141305331|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.081||0.451|TWO_SIDED|90.0|-0.1|0.23||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.23|-0.10|0.451
70908474|NCT04147260|141305331|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.11||1|TWO_SIDED|90.0|-0.22|0.22||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.22|-0.22|1.000
70908475|NCT04147260|141305332|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.152|||TWO_SIDED|90.0|-0.15|0.36|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.36|-0.15|
70908476|NCT04147260|141305332|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.131||0.446|TWO_SIDED|90.0|-0.16|0.36||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.36|-0.16|0.446
70908477|NCT04147260|141305332|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.172||0.972|TWO_SIDED|90.0|-0.34|0.35||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.35|-0.34|0.972
70908478|NCT04147260|141305332|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.182|||TWO_SIDED|90.0|-0.02|0.6|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.60|-0.02|
70908479|NCT04147260|141305332|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.15||0.091|TWO_SIDED|90.0|-0.04|0.56||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.56|-0.04|0.091
70908480|NCT04147260|141305332|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.203||0.88|TWO_SIDED|90.0|-0.38|0.44||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.44|-0.38|0.880
70908481|NCT04147260|141305333|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.043|||TWO_SIDED|90.0|-0.15|-0.01|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||-0.01|-0.15|
70908482|NCT04147260|141305333|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.037||0.757|TWO_SIDED|90.0|-0.09|0.06||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.06|-0.09|0.757
70908483|NCT04147260|141305333|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.049||0.158|TWO_SIDED|90.0|-0.17|0.03||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.03|-0.17|0.158
70908484|NCT04147260|141305333|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.101|||TWO_SIDED|90.0|-0.12|0.22|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.22|-0.12|
70908485|NCT04147260|141305333|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.083||0.33|TWO_SIDED|90.0|-0.09|0.25||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.25|-0.09|0.330
70908486|NCT04147260|141305333|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.113||0.754|TWO_SIDED|90.0|-0.26|0.19||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.19|-0.26|0.754
70908487|NCT04147260|141305334|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.128|||TWO_SIDED|90.0|0.09|0.52|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.52|0.09|
70908488|NCT04147260|141305334|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.11||0.151|TWO_SIDED|90.0|-0.06|0.38||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.38|-0.06|0.151
70908489|NCT04147260|141305334|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.145||0.319|TWO_SIDED|90.0|-0.15|0.44||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.44|-0.15|0.319
71153601|NCT03085797|141799600|OTHER||Odds Ratio (OR)|0.58||||0.02|TWO_SIDED|95.0|0.36|0.92||p-Value was based on logistic regression model and is adjusted for multiplicity.|Regression, Logistic||Covariates: treatment group, geographic region, number of oral corticosteroids courses for NP in last 12 months(0,1,\>1 as ordinal), Baseline total endoscopic score(centrally read),Baseline nasal obstruction VAS score,log(e) Baseline eosinophil count.|||0.92|0.36|0.020
70908490|NCT04147260|141305334|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.136|||TWO_SIDED|90.0|-0.04|0.42|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.42|-0.04|
70908491|NCT04147260|141305334|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.112||0.246|TWO_SIDED|90.0|-0.09|0.36||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.36|-0.09|0.246
70908492|NCT04147260|141305334|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.151||0.704|TWO_SIDED|90.0|-0.25|0.36||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.36|-0.25|0.704
70908493|NCT04147260|141305335|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-1.96|STANDARD_ERROR_OF_MEAN|4.929||0.692|TWO_SIDED|90.0|-11.92|7.99||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||7.99|-11.92|0.692
70908494|NCT04147260|141305335|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-1.96|STANDARD_ERROR_OF_MEAN|4.048||0.63|TWO_SIDED|90.0|-10.14|6.21||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||6.21|-10.14|0.630
70908495|NCT04147260|141305335|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|5.482||1|TWO_SIDED|90.0|-11.07|11.07||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||11.07|-11.07|1.000
70908496|NCT04147260|141305335|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|4.518||0.751|TWO_SIDED|90.0|-10.55|7.66||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||7.66|-10.55|0.751
70908497|NCT04147260|141305335|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|1.68|STANDARD_ERROR_OF_MEAN|3.894||0.669|TWO_SIDED|90.0|-6.17|9.52||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||9.52|-6.17|0.669
70908498|NCT04147260|141305335|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-3.12|STANDARD_ERROR_OF_MEAN|5.123||0.546|TWO_SIDED|90.0|-13.44|7.21||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||7.21|-13.44|0.546
70908499|NCT04147260|141305336|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-12.45|STANDARD_ERROR_OF_MEAN|11.385||0.281|TWO_SIDED|90.0|-35.44|10.54||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||10.54|-35.44|0.281
70908500|NCT04147260|141305336|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-16.14|STANDARD_ERROR_OF_MEAN|9.35||0.092|TWO_SIDED|90.0|-35.02|2.74||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||2.74|-35.02|0.092
70908501|NCT04147260|141305336|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|3.69|STANDARD_ERROR_OF_MEAN|12.662||0.772|TWO_SIDED|90.0|-21.88|29.27||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||29.27|-21.88|0.772
70908502|NCT04147260|141305336|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-8.21|STANDARD_ERROR_OF_MEAN|13.255||0.539|TWO_SIDED|90.0|-34.93|18.5||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||18.50|-34.93|0.539
70908503|NCT04147260|141305336|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-4.71|STANDARD_ERROR_OF_MEAN|11.424||0.682|TWO_SIDED|90.0|-27.74|18.31||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||18.31|-27.74|0.682
70908504|NCT04147260|141305336|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|15.03||0.817|TWO_SIDED|90.0|-33.79|26.79||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||26.79|-33.79|0.817
70969964|NCT02873936|141445709|SUPERIORITY||Least Squares Mean Difference|-17.0|STANDARD_ERROR_OF_MEAN|3.1|<|0.001|TWO_SIDED|95.0|-23.0|-11.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-11.0|-23.0|<0.001
70908505|NCT04147260|141305337|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|5.327||0.891|TWO_SIDED|90.0|-11.49|10.02||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||10.02|-11.49|0.891
70908506|NCT04147260|141305337|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-3.59|STANDARD_ERROR_OF_MEAN|4.375||0.417|TWO_SIDED|90.0|-12.42|5.25||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||5.25|-12.42|0.417
70908507|NCT04147260|141305337|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|2.85|STANDARD_ERROR_OF_MEAN|5.925||0.633|TWO_SIDED|90.0|-9.11|14.82||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||14.82|-9.11|0.633
70908508|NCT04147260|141305337|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|6.79|STANDARD_ERROR_OF_MEAN|4.384||0.129|TWO_SIDED|90.0|-2.05|15.62||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||15.62|-2.05|0.129
70908509|NCT04147260|141305337|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|2.29|STANDARD_ERROR_OF_MEAN|3.778||0.548|TWO_SIDED|90.0|-5.33|9.9||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||9.90|-5.33|0.548
70908510|NCT04147260|141305337|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|4.5|STANDARD_ERROR_OF_MEAN|4.97||0.37|TWO_SIDED|90.0|-5.51|14.52||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||14.52|-5.51|0.370
70908511|NCT04147260|141305338|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-9.3|STANDARD_ERROR_OF_MEAN|10.379||0.375|TWO_SIDED|90.0|-30.26|11.66||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||11.66|-30.26|0.375
70908512|NCT04147260|141305338|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-11.49|STANDARD_ERROR_OF_MEAN|8.524||0.185|TWO_SIDED|90.0|-28.7|5.73||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||5.73|-28.70|0.185
70908513|NCT04147260|141305338|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|2.19|STANDARD_ERROR_OF_MEAN|11.544||0.851|TWO_SIDED|90.0|-21.12|25.5||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||25.50|-21.12|0.851
70908514|NCT04147260|141305338|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-26.64|STANDARD_ERROR_OF_MEAN|9.405||0.007|TWO_SIDED|90.0|-45.59|-7.69||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||-7.69|-45.59|0.007
70908515|NCT04147260|141305338|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-15.01|STANDARD_ERROR_OF_MEAN|8.106||0.071|TWO_SIDED|90.0|-31.34|1.33||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||1.33|-31.34|0.071
70908516|NCT04147260|141305338|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-11.63|STANDARD_ERROR_OF_MEAN|10.664||0.281|TWO_SIDED|90.0|-33.13|9.86||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||9.86|-33.13|0.281
70908517|NCT04147260|141305339|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-2.84|STANDARD_ERROR_OF_MEAN|5.37||0.599|TWO_SIDED|90.0|-13.69|8.0||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||8.00|-13.69|0.599
70908518|NCT04147260|141305339|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.99|STANDARD_ERROR_OF_MEAN|4.41||0.824|TWO_SIDED|90.0|-7.92|9.9||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||9.90|-7.92|0.824
70908519|NCT04147260|141305339|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-3.83|STANDARD_ERROR_OF_MEAN|5.973||0.525|TWO_SIDED|90.0|-15.9|8.23||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||8.23|-15.90|0.525
70908520|NCT04147260|141305339|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-8.0|STANDARD_ERROR_OF_MEAN|6.867||0.25|TWO_SIDED|90.0|-21.84|5.84||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||5.84|-21.84|0.250
70908521|NCT04147260|141305339|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|5.19|STANDARD_ERROR_OF_MEAN|5.919||0.386|TWO_SIDED|90.0|-6.74|17.12||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||17.12|-6.74|0.386
70908522|NCT04147260|141305339|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-13.19|STANDARD_ERROR_OF_MEAN|7.787||0.097|TWO_SIDED|90.0|-28.88|2.51||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||2.51|-28.88|0.097
70908523|NCT04147260|141305340|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.99|STANDARD_ERROR_OF_MEAN|6.842||0.885|TWO_SIDED|90.0|-12.83|14.81||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||14.81|-12.83|0.885
70908524|NCT04147260|141305340|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|28.9|STANDARD_ERROR_OF_MEAN|5.619|<|0.001|TWO_SIDED|90.0|17.55|40.25||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||40.25|17.55|<0.001
70908525|NCT04147260|141305340|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-27.91|STANDARD_ERROR_OF_MEAN|7.61|<|0.001|TWO_SIDED|90.0|-43.28|-12.54||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||-12.54|-43.28|<0.001
70908526|NCT04147260|141305340|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-20.13|STANDARD_ERROR_OF_MEAN|8.041||0.016|TWO_SIDED|90.0|-36.33|-3.92||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||-3.92|-36.33|0.016
70908527|NCT04147260|141305340|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|18.5|STANDARD_ERROR_OF_MEAN|6.931||0.011|TWO_SIDED|90.0|4.53|32.46||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||32.46|4.53|0.011
70908528|NCT04147260|141305340|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-38.62|STANDARD_ERROR_OF_MEAN|9.118|<|0.001|TWO_SIDED|90.0|-57.0|-20.25||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||-20.25|-57.00|<0.001
70908529|NCT02204293|141305362|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.||||||0.1811|||||||Fisher Exact|||||||0.1811
70908530|NCT02204293|141305377|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|19.9||||0.3175|TWO_SIDED|95.0|-15.0|51.3|||Fisher Exact|||||51.3|-15.0|0.3175
70908531|NCT02204293|141305378|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|31.7||||0.0922|TWO_SIDED|95.0|-2.9|61.8|||Fisher Exact|||||61.8|-2.9|0.0922
70908532|NCT02204293|141305379|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|32.0||||0.0858|TWO_SIDED|95.0|-1.5|61.1|||Fisher Exact|||||61.1|-1.5|0.0858
70908533|NCT02204293|141305380|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|32.4||||0.075|TWO_SIDED|95.0|-0.7|60.5|||Fisher Exact|||||60.5|-0.7|0.075
70908534|NCT02204293|141305381|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|16.0||||0.4018|TWO_SIDED|95.0|-12.6|43.4|||Fisher Exact|||||43.4|-12.6|0.4018
70908535|NCT02204293|141305382|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|5.2||||1|TWO_SIDED|95.0|-18.8|29.2|||Fisher Exact|||||29.2|-18.8|1
70908536|NCT02204293|141305383|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|24.8||||0.1642|TWO_SIDED|95.0|-8.0|54.2|||Fisher Exact|||EULAR DAS28-ESR Response||54.2|-8.0|0.1642
70908537|NCT02204293|141305383|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|25.2||||0.1756|TWO_SIDED|95.0|-9.1|55.1|||Fisher Exact|||EULAR DAS28-CRP Response||55.1|-9.1|0.1756
70908538|NCT02204293|141305384|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|3.9||||1|TWO_SIDED|95.0|-27.7|35.0|||Fisher Exact|||DAS28 (ESR) LDA||35.0|-27.7|1
70908539|NCT02204293|141305384|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|26.5||||0.1642|TWO_SIDED|95.0|-6.6|56.0|||Fisher Exact|||DAS28 (CRP) LDA||56.0|-6.6|0.1642
70908540|NCT02204293|141305385|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|21.6||||0.2285|TWO_SIDED|95.0|-8.1|49.9|||Fisher Exact|||DAS28 (ESR) remission||49.9|-8.1|0.2285
70908541|NCT02204293|141305385|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|27.1||||0.1212|TWO_SIDED|95.0|-4.6|54.6|||Fisher Exact|||DAS28 (CRP) Remission||54.6|-4.6|0.1212
70908542|NCT02204293|141305385|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|16.0||||0.4018|TWO_SIDED|95.0|-12.6|43.4|||Fisher Exact|||Extended Remission||43.4|-12.6|0.4018
70908543|NCT02397460|141305453|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Treatment effects on Emax following capsaicin challenge were modeled for dose dependence and were estimated on the basis of disease status for participants who were healthy or had chronic cough and received gefapixant 50 mg, gefapixant 300 mg, or placebo.||||< 0.0001
70908544|NCT02397460|141305454|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Treatment effects following capsaicin challenge were modeled for dose. dependence and were estimated on the basis of disease status for participants who had chronic cough and received gefapixant 50 mg, gefapixant 300 mg, or placebo.||||< 0.0001
70908545|NCT02040090|141305486|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|We will reject the null hypothesis at the one-sided 5% significance level, and conclude that Cp \> -0.1, if the lower bound of an exact 90% binomial confidence interval (CI) exceeds0.1. A sample size of 53 in each group provides 80% power to reject the null hypothesis.|Mean Difference (Net)|-0.018|||||TWO_SIDED|90.0|-0.082|0.031||||||The null hypothesis was that Cp ≤ -0.1.||0.031|-0.082|
70908546|NCT04894903|141305487|OTHER||Odds Ratio (OR)|0.45|||<|0.001|TWO_SIDED|95.0|0.3|0.68||This is the calculated p-value. We used an alpha level of 0.05|Mixed Models Analysis|Adjusted for baseline number of gaps||||0.68|0.30|<0.001
70908547|NCT04894903|141305489|OTHER||Odds Ratio (OR)|0.57||||0.29|TWO_SIDED|95.0|0.2|1.62|||Mixed Models Analysis|||||1.62|0.20|0.29
70908548|NCT04894903|141305490|OTHER||beta coefficient|-0.04||||0.74|TWO_SIDED|95.0|-0.24|0.17|||Mixed Models Analysis|||||0.17|-0.24|0.74
70908549|NCT04894903|141305491|OTHER||beta coefficient|-0.04||||0.88|TWO_SIDED|95.0|-0.6|0.51|||Mixed Models Analysis|||||0.51|-0.60|0.88
70908550|NCT04894903|141305492|OTHER||beta coefficient|-1.24||||0.21|TWO_SIDED|95.0|-3.19|0.71|||Mixed Models Analysis|||||0.71|-3.19|0.21
70908551|NCT04894903|141305495|OTHER||beta coefficient|0.47||||0.21|TWO_SIDED|95.0|-0.27|1.22|||Mixed Models Analysis|||||1.22|-0.27|0.21
70908552|NCT04793464|141305524|SUPERIORITY||Mean Difference (Final Values)|0.77||||0.26|TWO_SIDED||||||ANCOVA|||Number analyzed is the number of participants with valid baseline and follow-up data.||||.26
70908553|NCT04793464|141305525|SUPERIORITY||Mean Difference (Final Values)|0.87||||0.02|TWO_SIDED||||||ANCOVA|Ratio of Means||Number analyzed is the number of participants with valid baseline and follow-up data.||||.02
70908554|NCT04793464|141305526|SUPERIORITY||Odds Ratio (OR)|1.1||||0.68|TWO_SIDED||||||ANCOVA|Logistic regression||Number analyzed is the number of participants with valid baseline and follow-up data.||||.68
70908555|NCT04793464|141305527|SUPERIORITY||Odds Ratio (OR)|1.19||||0.44|TWO_SIDED||||||ANCOVA|Logistic regression||Number analyzed is the number of participants with valid baseline and follow-up data.||||.44
70908556|NCT04793464|141305528|SUPERIORITY||Mean Difference (Final Values)|0.015||||0.77|TWO_SIDED||||||ANCOVA|||Number analyzed is the number of participants with valid baseline and follow-up data.||||.77
70908557|NCT04793464|141305529|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.66|TWO_SIDED||||||ANCOVA|||Number analyzed is the number of participants with valid baseline and follow-up data.||||.66
70908558|NCT04793464|141305530|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.44|TWO_SIDED||||||ANCOVA|||Number analyzed is the number of participants with valid baseline and follow-up data.||||.44
70908559|NCT04793464|141305531|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.017|TWO_SIDED||||||ANCOVA|||Number analyzed is the number of participants with valid baseline and follow-up data.||||0.017
70908560|NCT00519636|141305603|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|0.24|<|0.001||95.0|-1.3|-0.3|||ANCOVA||Mean Difference = Mean Change in FFNS - Mean Change in Placebo.|FFNS combined across treatment arms 1 (FFNS/FPNS) \& 2 (Placebo FF/FP) compared with Placebo FFNS combined across treatment arms 1 (FFNS/FPNS) \& 2 (Placebo FF/FP).||-0.3|-1.3|<0.001
70908561|NCT00519636|141305603|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.24||0.014||95.0|-1.1|-0.1|||ANCOVA||Mean Difference = Mean Change in FPNS - Mean Change in Placebo.|FPNS combined across treatment arms 1 (FPNS/FFNS) \& 2 (Placebo FP/FF) compared with Placebo FPNS combined across treatment arms 1 (FPNS/FFNS)\& 2 (Placebo FP/FF).||-0.1|-1.1|0.014
70908562|NCT00519636|141305604|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH): stratified approximate to Prescotts test; variation of chi-square test for treatment sequence/subjects no preference.||||||<0.001
70908563|NCT00050089|141305611|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.165||||0.69|TWO_SIDED|95.0|0.856|1.585|||Log Rank||The comparison was Mega-ART (intensification) vs Standard-ART (standard).|Time-to-event (Kaplan-Meier) and stratified log-rank test was used for the comparison.||1.585|0.856|0.69
70908564|NCT00050089|141305612|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.927||||0.49|TWO_SIDED|95.0|0.674|1.275|||Log Rank||The comparison was ARDFP (interruption) vs No ARDFP (continuation)|Time-to-event (Kaplan-Meier) and stratified log-rank analysis was performed.||1.275|0.674|0.49
70908565|NCT00050089|141305613|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Log Rank|||Stratified Log-rank test was used to compare the four treatment||||0.87
70908566|NCT00050089|141305614|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.008||||0.92|TWO_SIDED|95.0|0.75|1.35|||Log Rank||The comparison was Standard-ART (standard) vs Mega-ART (intensification)|Time-to-event (Kaplan-Meier) and stratified log-rank test was used for the comparison||1.35|0.75|0.92
70908567|NCT00050089|141305615|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.68|TWO_SIDED|95.0|0.8|1.46|||Log Rank||The comparison was ARDFP (interruption) vs No ARDFP (continuation) of ART|Time-to-event (Kaplan-Meier) and stratified log-rank test was used for the comparison.||1.46|0.8|0.68
70908568|NCT01671748|141305616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.4||||0.565|TWO_SIDED|95.0|-33.4|18.6||ANCOVA was used to analyse differences between the NLFU+SOC and SOC arms of the primary endpoint, percentage change in wound area from baseline (week 5) to final visit (week 13). Patients' baseline (week 5) wound area was used as the covariate.|ANCOVA|||The study was powered to detect a difference in the change in wound area of 20% between the two arms with a two sided significance level and power of 90%. A standard deviation of 17.5% came from published literature. A minimum of 17 patients in each arm was required.||18.6|-33.4|0.565
70908569|NCT01671748|141305617|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||ANCOVA|||ANCOVA was used for change in HRQoL from week 1 to week 13 (with week 1 HRQoL score as the covariate).||||0.490
70908570|NCT01671748|141305618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.08||||0.078|TWO_SIDED|95.0|-19.23|1.06|||ANCOVA|||ANCOVA was used for change in pain score (VAS) from week 5 to week 13 (covariate was baseline pain score).||1.06|-19.23|0.078
70908571|NCT01671748|141305619|SUPERIORITY_OR_OTHER|||||||0.346|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change in number of infections were not normally distributed and differences between the arms were tested using the non-parametric Mann-Whitney U test.||||0.346
70908572|NCT01671748|141305621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.618|TWO_SIDED|95.0|-4.7|2.9|||ANCOVA|Patients' baseline (week 5) wound area was used as the covariate.||||2.9|-4.7|0.618
70908573|NCT02555371|141305624|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.004|TWO_SIDED|95.0|0.45|0.86|||Cox Proportional Hazards Model||Treatment comparison between mepolizumab 100 mg SC and placebo using hazards ratio and 95% confidence interval has been presented.|||0.86|0.45|0.004
70908574|NCT02555371|141305625|SUPERIORITY||Ratio|0.19|||<|0.001|TWO_SIDED|95.0|0.15|0.24|||Mixed model repeated measures||Treatment comparison between mepolizumab 100 mg SC and placebo using ratio of mepolizumab to placebo and its 95% confidence interval at Week 12 has been presented.|||0.24|0.15|<0.001
70908575|NCT02555371|141305625|SUPERIORITY||Ratio|0.16|||<|0.001|TWO_SIDED|95.0|0.12|0.2|||Mixed model repeated measures||Treatment comparison between mepolizumab 100 mg SC and placebo using ratio of mepolizumab to placebo and its 95% confidence interval at Week 24 has been presented.|||0.20|0.12|<0.001
70908576|NCT02555371|141305625|SUPERIORITY||Ratio|0.19|||<|0.001|TWO_SIDED|95.0|0.15|0.24|||Mixed model repeated measures||Treatment comparison between mepolizumab 100 mg SC and placebo using ratio of mepolizumab to placebo and its 95% confidence interval at Week 36 has been presented.|||0.24|0.15|<0.001
70908577|NCT02555371|141305625|SUPERIORITY||Ratio|0.16|||<|0.001|TWO_SIDED|95.0|0.13|0.2|||Mixed model repeated measures||Treatment comparison between mepolizumab 100 mg SC and placebo using ratio of mepolizumab to placebo and its 95% confidence interval at Week 52 has been presented.|||0.20|0.13|<0.001
70908578|NCT02555371|141305626|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.005|TWO_SIDED|95.0|0.49|0.88|||Cox Proportional Hazards Model||Treatment comparison between mepolizumab 100 mg SC and placebo using hazards ratio and 95% confidence interval has been presented.|||0.88|0.49|0.005
70908579|NCT02555371|141305627|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.57|TWO_SIDED|95.0|0.5|3.51|||Cox Proportional Hazards Model||Treatment comparison between mepolizumab 100 mg SC and placebo using hazards ratio and 95% confidence interval has been presented.|||3.51|0.50|0.570
70908580|NCT03615482|141305629|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|-0.9||||0.617|TWO_SIDED|95.0|-4.5|2.7|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Injection-Site Erythema||2.7|-4.5|0.617
70908581|NCT03615482|141305629|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|-2.6||||0.32|TWO_SIDED|95.0|-7.8|2.6|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Injection-Site Pain||2.6|-7.8|0.320
70908582|NCT03615482|141305629|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|-2.1||||0.31|TWO_SIDED|95.0|-6.2|2.0|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Injection-Site Swelling||2.0|-6.2|0.310
70908583|NCT03615482|141305630|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|-2.2||||0.205|TWO_SIDED|95.0|-5.8|1.2|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Arthralgia||1.2|-5.8|0.205
70908584|NCT03615482|141305630|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|-2.9||||0.273|TWO_SIDED|95.0|-8.0|2.3|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Fatigue||2.3|-8.0|0.273
70908585|NCT03615482|141305630|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|-2.2||||0.372|TWO_SIDED|95.0|-6.9|2.6|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Headache||2.6|-6.9|0.372
70908586|NCT03615482|141305630|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|2.4||||0.329|TWO_SIDED|95.0|-2.4|7.1|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Myalgia||7.1|-2.4|0.329
70908587|NCT03615482|141305631|OTHER||Difference in Percent|0.0|||||TWO_SIDED|95.0|-0.6|0.6||||||||0.6|-0.6|
70908588|NCT03615482|141305632|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.66||||0.004|TWO_SIDED|95.0|0.54|0.82|||cLDA|GMT ratio, 95% CI and p-value were estimated from a constrained longitudinal data analysis (cLDA) model including all vaccinated participants.||Serotype 1||0.82|0.54|0.004
70908589|NCT03615482|141305632|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.81|1.09|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 3||1.09|0.81|<0.001
70908590|NCT03615482|141305632|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.84|||<|0.001|TWO_SIDED|95.0|0.69|1.01|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 4||1.01|0.69|<0.001
70908591|NCT03615482|141305632|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.64|0.98|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 5||0.98|0.64|<0.001
70908592|NCT03615482|141305632|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.84|||<|0.001|TWO_SIDED|95.0|0.71|1.0|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 6A||1.00|0.71|<0.001
70908593|NCT03615482|141305632|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.88|||<|0.001|TWO_SIDED|95.0|0.74|1.04|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 6B||1.04|0.74|<0.001
70908594|NCT03615482|141305632|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.86|||<|0.001|TWO_SIDED|95.0|0.75|0.99|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 7F||0.99|0.75|<0.001
71153602|NCT03085797|141799601|OTHER||Difference in Medians|-2.68||||0.02|TWO_SIDED|95.0|-3.44|-1.91||p-Value was based on Wilcoxon rank-sum test and is adjusted for multiplicity.|Wilcoxon rank-sum test||Quantile regression with covariates: treatment, region, Baseline score, Baseline BEC. Par. with nasal surgery prior to Wks 49-52/withdrew early with no nasal surgery assigned their worst observed 4-wk mean prior to nasal surgery/study withdrawal.|||-1.91|-3.44|0.020
70908595|NCT03615482|141305632|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.99|||<|0.001|TWO_SIDED|95.0|0.86|1.15|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 9V||1.15|0.86|<0.001
70908596|NCT03615482|141305632|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.91|||<|0.001|TWO_SIDED|95.0|0.77|1.08|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 14||1.08|0.77|<0.001
70908597|NCT03615482|141305632|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.68|0.92|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 18C||0.92|0.68|<0.001
70908598|NCT03615482|141305632|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.73|0.95|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 19A||0.95|0.73|<0.001
70908599|NCT03615482|141305632|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.89|1.17|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 19F||1.17|0.89|<0.001
70908600|NCT03615482|141305632|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.77|||<|0.001|TWO_SIDED|95.0|0.64|0.91|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 22F||0.91|0.64|<0.001
70908601|NCT03615482|141305632|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.85|||<|0.001|TWO_SIDED|95.0|0.7|1.03|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 23F||1.03|0.70|<0.001
70908602|NCT03615482|141305632|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.72|0.96|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 33F||0.96|0.72|<0.001
70908603|NCT03615482|141305633|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.94|1.25|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||H1N1||1.25|0.94|<0.001
70908604|NCT03615482|141305633|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.9|1.17|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||H3N2||1.17|0.90|<0.001
70908605|NCT03615482|141305633|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.86|1.08|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||B-Victoria||1.08|0.86|<0.001
70908606|NCT03615482|141305633|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.9|1.13|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||B-Yamagata||1.13|0.90|<0.001
70908607|NCT03615482|141305634|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.77|||||TWO_SIDED|95.0|0.67|0.89||||||Serotype 1||0.89|0.67|
70908608|NCT03615482|141305634|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.87|||||TWO_SIDED|95.0|0.76|0.99||||||Serotype 3||0.99|0.76|
70908609|NCT03615482|141305634|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.68|0.91||||||Serotype 4||0.91|0.68|
70908610|NCT03615482|141305634|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.89|||||TWO_SIDED|95.0|0.77|1.02||||||Serotype 5||1.02|0.77|
70908611|NCT03615482|141305634|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.73|||||TWO_SIDED|95.0|0.61|0.87||||||Serotype 6A||0.87|0.61|
70908612|NCT03615482|141305634|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.77|||||TWO_SIDED|95.0|0.64|0.91||||||Serotype 6B||0.91|0.64|
70908613|NCT03615482|141305634|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.88|||||TWO_SIDED|95.0|0.76|1.01||||||Serotype 7F||1.01|0.76|
70908614|NCT03615482|141305634|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.9|||||TWO_SIDED|95.0|0.79|1.03||||||Serotype 9V||1.03|0.79|
70908615|NCT03615482|141305634|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.85|||||TWO_SIDED|95.0|0.73|0.99||||||Serotype 14||0.99|0.73|
70908616|NCT03615482|141305634|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.78|||||TWO_SIDED|95.0|0.68|0.91||||||Serotype 18C||0.91|0.68|
70908617|NCT03615482|141305634|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.89|||||TWO_SIDED|95.0|0.78|1.02||||||Serotype 19A||1.02|0.78|
70908618|NCT03615482|141305634|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.89|||||TWO_SIDED|95.0|0.77|1.03||||||Serotype 19F||1.03|0.77|
70908619|NCT03615482|141305634|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.76|||||TWO_SIDED|95.0|0.65|0.89||||||Serotype 22F||0.89|0.65|
70908620|NCT03615482|141305634|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.7|0.98||||||Serotype 23F||0.98|0.70|
70908621|NCT03615482|141305634|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.86|||||TWO_SIDED|95.0|0.75|0.99||||||Serotype 33F||0.99|0.75|
70908622|NCT01500226|141305642|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.2|2.0||To control for multiplicity, analyses were performed hierarchically. For the CR delayed the threshold for statistical significance was 0.05; no further adjustment for multiplicity were required for the primary endpoint.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.0|1.2|<0.001
70908623|NCT01500226|141305643|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.143|TWO_SIDED|95.0|0.9|1.6||To control for multiplicity, analyses were performed hierarchically. CR-acute was tested only if the result for the primary endpoint, CR delayed, was statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||1.6|0.9|0.143
70908624|NCT01500226|141305644|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.3|2.0||To control for multiplicity, analyses were performed hierarchically. CR overall was tested only if both CR delayed and CR acute were statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.0|1.3|<0.001
70908625|NCT01603940|141305653|SUPERIORITY_OR_OTHER|||||||0.616|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.616
70908626|NCT01603940|141305654|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.28
70908627|NCT01603940|141305655|SUPERIORITY_OR_OTHER|||||||0.618|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.618
70908628|NCT02571439|141305732|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70908629|NCT02571439|141305733|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70908630|NCT02571439|141305734|OTHER|||||||0.61|||||||Kruskal-Wallis|||||||0.61
70908631|NCT02571439|141305735|OTHER|||||||0.46|||||||Kruskal-Wallis|||||||0.46
70908632|NCT02571439|141305736|OTHER|||||||0.33|||||||Kruskal-Wallis|||||||0.33
70908633|NCT02571439|141305737|OTHER|||||||0.13|||||||Kruskal-Wallis|||||||0.13
70908634|NCT02571439|141305738|OTHER|||||||0.17|||||||Kruskal-Wallis|||||||0.17
70908635|NCT02571439|141305739|OTHER|||||||0.87|||||||Kruskal-Wallis|||||||0.87
70908636|NCT02571439|141305740|OTHER|||||||0.27|||||||Chi-squared|||||||0.27
70908637|NCT02571439|141305741|OTHER|||||||0.91|||||||Kruskal-Wallis|||||||0.91
70908638|NCT01058863|141305746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.15|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.88|1.42||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline FEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||1.42|0.88|<0.0001
70908639|NCT01058863|141305746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.7|1.24||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline FEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||1.24|0.70|<0.0001
70908640|NCT01058863|141305746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.08|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.81|1.35||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline FEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level..||1.35|0.81|<0.0001
70908641|NCT01058863|141305746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.88|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.61|1.15||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline FEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||1.15|0.61|<0.0001
71153603|NCT03085797|141799602|OTHER||Difference in Medians|-0.37||||0.02|TWO_SIDED|95.0|-0.65|-0.08||p-Value was based on Wilcoxon rank-sum test and is adjusted for multiplicity.|Wilcoxon rank-sum test||Quantile regression with covariates: treatment, region, Baseline score, Baseline BEC. Par. with nasal surgery prior to Wks 49-52/withdrew early with no nasal surgery assigned their worst observed 4-wk mean prior to nasal surgery/study withdrawal.|||-0.08|-0.65|0.020
70908642|NCT01058863|141305747|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|33.47|STANDARD_ERROR_OF_MEAN|3.69|<|0.0001|TWO_SIDED|95.0|26.21|40.74||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline PPFEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||40.74|26.21|<0.0001
70908643|NCT01058863|141305747|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|27.73|STANDARD_ERROR_OF_MEAN|3.686|<|0.001|TWO_SIDED|95.0|20.47|34.99||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline PPFEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||34.99|20.47|<0.001
70908644|NCT01058863|141305747|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|33.1|STANDARD_ERROR_OF_MEAN|3.686|<|0.0001|TWO_SIDED|95.0|25.84|40.35||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline PPFEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||40.35|25.84|<0.0001
70969965|NCT02873936|141445709|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|3.1|<|0.001|TWO_SIDED|95.0|-19.0|-7.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-19.0|<0.001
71008707|NCT02055976|141525244|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|16.252|STANDARD_ERROR_OF_MEAN|3.367|<|0.001|TWO_SIDED|95.0|9.56|22.943|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||22.943|9.560|<0.001
70908645|NCT01058863|141305747|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|25.61|STANDARD_ERROR_OF_MEAN|3.68|<|0.0001|TWO_SIDED|95.0|18.36|32.85||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline PPFEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||32.85|18.36|<0.0001
70908646|NCT04230980|141305766|SUPERIORITY||Mean Difference (Final Values)|-1.13||||0.01|TWO_SIDED|95.0|-2.02|-0.24|||t-test, 2 sided||Direction of mean difference is Gabapentin arm minus placebo arm.|Mean NRS-11 score at post-operative day 7 (compared between the two arms).||-0.24|-2.02|0.01
70908647|NCT04230980|141305767|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.19|TWO_SIDED|95.0|-0.13|0.03|||t-test, 2 sided||Direction of mean difference is Gabapentin arm minus placebo arm.|Mean number of opioid tablets taken at post-operative day 7 (compared between the two arms).||0.03|-0.13|0.19
70908648|NCT00598481|141305780|SUPERIORITY|||||||0.005|||||||One-sided Poisson-regression|||||||0.005
70908649|NCT00598481|141305781|SUPERIORITY||Geometric mean ratio|3.0||||0.003|TWO_SIDED|95.0|1.45|6.19||P value related to geometric mean ratio at 1 year post gene therapy compared to baseline|Mixed Model Repeated Measures|||||6.19|1.45|0.003
70908650|NCT00598481|141305781|SUPERIORITY||Geometric mean ratio|5.4|||<|0.001|TWO_SIDED|95.0|2.63|11.25||P value related to geometric mean ratio at 2 years post gene therapy compared to baseline|Mixed Model Repeated Measures|||||11.25|2.63|<0.001
70908651|NCT00598481|141305781|SUPERIORITY||Geometric mean ratio|6.5|||<|0.001|TWO_SIDED|95.0|3.08|13.64||P value related to geometric mean ratio at 3 years post gene therapy compared to baseline|Mixed Model Repeated Measures|||||13.64|3.08|<0.001
70908652|NCT01994720|141305784|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.067|TWO_SIDED|95.0|0.78|1.01||In order to address the issue of multiple testing, a hierarchical test sequence will be used. Tested at 4.98% level.|Regression, Cox|||Composite of stroke/MI/death||1.01|0.78|0.0670
70908653|NCT01994720|141305785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.0462|TWO_SIDED|95.0|0.76|1.0||If the treatment effect on the primary efficacy variable is significant at the 4.98% level, the secondary efficacy variable will be tested in a confirmatory sense. Otherwise it will be tested in an exploratory manner.|Regression, Cox|||Ischemic stroke||1.00|0.76|0.0462
70908654|NCT01994720|141305786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.0928|TWO_SIDED|95.0|0.79|1.02|||Regression, Cox|||||1.02|0.79|0.0928
70908655|NCT01994720|141305787|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.0771|TWO_SIDED|95.0|0.78|1.01|||Regression, Cox|||||1.01|0.78|0.0771
70908656|NCT01994720|141305788|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.3641|TWO_SIDED|95.0|0.83|1.67|||Regression, Cox|||||1.67|0.83|0.3641
70908657|NCT01994720|141305789|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.4828|TWO_SIDED|95.0|0.75|1.85|||Regression, Cox|||||1.85|0.75|0.4828
70908658|NCT01994720|141305790|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.5457|TWO_SIDED|95.0|0.67|2.14|||Regression, Cox|||||2.14|0.67|0.5457
71153604|NCT01837823|141799613|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.231||||0.054|TWO_SIDED||||||Regression, Linear|||||||0.054
70908659|NCT01994720|141305791|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.1393|TWO_SIDED|95.0|0.85|1.02|||Regression, Logistic|||||1.02|0.85|0.1393
70908660|NCT01994720|141305792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.0342|TWO_SIDED|95.0|0.75|0.99|||Regression, Cox|||||0.99|0.75|0.0342
70908661|NCT01994720|141305793|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.8557|TWO_SIDED|95.0|0.55|2.06|||Regression, Cox|||||2.06|0.55|0.8557
70908662|NCT01994720|141305794|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.2126|TWO_SIDED|95.0|0.77|1.06|||Regression, Cox|||||1.06|0.77|0.2126
70908663|NCT01994720|141305800|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.4511|TWO_SIDED|95.0|0.52|1.34|||Regression, Cox|||PLATO Major bleeding||1.34|0.52|0.4511
70908664|NCT01994720|141305801|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.26|||<|0.0001|TWO_SIDED|95.0|1.53|3.34|||Regression, Cox|||||3.34|1.53|<0.0001
70908665|NCT01991197|141305802|SUPERIORITY||U value|43.5||||0.648|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.648
70908666|NCT01991197|141305805|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
70908667|NCT01991197|141305808|SUPERIORITY||U|29.5||||0.128|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.128
70908668|NCT02216422|141305820|SUPERIORITY_OR_OTHER||Percentage of Participants|100.0|||||TWO_SIDED|95.0|90.4|100.0|||||95% confidence interval (CI) was calculated using Wilson score method.|||100.0|90.4|
70908669|NCT04285229|141305823|SUPERIORITY||Odds Ratio (OR)|7.64|||<|0.001|TWO_SIDED|95.0|2.68|21.76|||Regression, Logistic|||||21.76|2.68|<0.001
70908670|NCT04285229|141305824|SUPERIORITY||Odds Ratio (OR)|6.4|||<|0.001|TWO_SIDED|95.0|2.42|16.9|||Regression, Logistic|||||16.90|2.42|<0.001
70908671|NCT04285229|141305825|SUPERIORITY||Odds Ratio (OR)|2.58||||0.006|TWO_SIDED|95.0|1.31|5.09|||Regression, Logistic|||||5.09|1.31|0.006
70908672|NCT04285229|141305826|SUPERIORITY||LS Mean Difference|-1.14|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-1.38|-0.9|||Mixed Models Analysis|||||-0.90|-1.38|<0.001
70908673|NCT04285229|141305827|SUPERIORITY||LS Mean Difference|-1.49|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.04|-0.94|||Mixed Models Analysis|||||-0.94|-2.04|<0.001
70908674|NCT04285229|141305828|SUPERIORITY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.28||0.002|TWO_SIDED|95.0|-1.43|-0.32|||Mixed Models Analysis|||||-0.32|-1.43|0.002
70908675|NCT04285229|141305829|SUPERIORITY||LS Mean Difference|-7.72|STANDARD_ERROR_OF_MEAN|1.58|<|0.001|TWO_SIDED|95.0|-10.85|-4.6|||ANCOVA|||||-4.60|-10.85|<0.001
71153605|NCT01837823|141799614|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.074||||0.5|TWO_SIDED||||||Pearson correlation coefficient|||for minimum lumen area site||||0.50
70908676|NCT04285229|141305830|SUPERIORITY||LS Mean Difference|2.62|STANDARD_ERROR_OF_MEAN|0.785||0.001|TWO_SIDED|95.0|1.07|4.17|||Mixed Models Analysis|||||4.17|1.07|0.001
70908677|NCT04285229|141305831|SUPERIORITY||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|1.152||0.66|TWO_SIDED|95.0|-1.77|2.79|||Mixed Models Analysis|||||2.79|-1.77|0.660
70908678|NCT04285229|141305832|SUPERIORITY||LS Mean Difference|-12.75|STANDARD_ERROR_OF_MEAN|1.594|<|0.001|TWO_SIDED|95.0|-15.91|-9.59|||Mixed Models Analysis|||||-9.59|-15.91|<0.001
70908679|NCT04285229|141305833|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.106|<|0.001|TWO_SIDED|95.0|-0.57|-0.15|||Mixed Models Analysis|||||-0.15|-0.57|<0.001
70908680|NCT04285229|141305834|SUPERIORITY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.413||0.086|TWO_SIDED|95.0|-1.54|0.1|||Mixed Models Analysis|||||0.10|-1.54|0.086
70908681|NCT04285229|141305835|SUPERIORITY||LS Mean Difference|-5.67|STANDARD_ERROR_OF_MEAN|1.034|<|0.001|TWO_SIDED|95.0|-7.71|-3.62|||ANCOVA|||||-3.62|-7.71|<0.001
70908682|NCT01767129|141305869|SUPERIORITY||Mean Difference (Final Values)|-83.4||||0.1907|TWO_SIDED|95.0|-215.02|48.23|||ANOVA|The standard analysis of variance (ANOVA) model for a 2-period crossover trial was used. Factors in the model were participant, treatment, and period.|The least squares (LS) mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||48.23|-215.02|0.1907
70908683|NCT01767129|141305870|SUPERIORITY||Median Difference (Final Values)|-18.9||||0.388|TWO_SIDED|95.0|-65.28|27.42|||ANOVA|The standard ANOVA model for a 2-period crossover trial was used. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||27.42|-65.28|0.3880
70908684|NCT01767129|141305871|SUPERIORITY||Mean Difference (Final Values)|171.9||||0.7574|TWO_SIDED|95.0|-1022.79|1366.64|||ANOVA|The standard ANOVA model for a 2-period crossover trial was used. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||1366.64|-1022.79|0.7574
70908685|NCT01767129|141305872|SUPERIORITY||Mean Difference (Final Values)|48.8||||0.4203|TWO_SIDED|95.0|-80.63|178.3|||ANOVA|The standard ANOVA model for a 2-period crossover trial was used. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||178.30|-80.63|0.4203
70908686|NCT01767129|141305873|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.1067|TWO_SIDED|95.0|-2.41|0.27|||ANOVA|Change from Day 1 values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Part I||0.27|-2.41|0.1067
70908687|NCT01767129|141305873|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.865|TWO_SIDED|95.0|-2.64|3.09|||ANOVA|Change from Day 1 values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Part II||3.09|-2.64|0.8650
70908688|NCT01767129|141305873|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.0745|TWO_SIDED|95.0|-4.94|0.27|||ANOVA|Change from Day 1 values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Part IV||0.27|-4.94|0.0745
70908689|NCT01767129|141305874|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.0625|TWO_SIDED|95.0|-8.1|0.24|||ANOVA|Change from Day 1 values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Part 1||0.24|-8.10|0.0625
70908690|NCT01767129|141305874|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.2474|TWO_SIDED|95.0|-3.74|1.07|||ANOVA|Change from Day 1 values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Part 2||1.07|-3.74|0.2474
70908691|NCT01767129|141305875|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9764|TWO_SIDED|95.0|-3.1|3.01|||ANOVA|Change from Day 1 values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||3.01|-3.10|0.9764
70908692|NCT01767129|141305876|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.6359|TWO_SIDED|95.0|-9.94|6.36|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Mobility||6.36|-9.94|0.6359
70908693|NCT01767129|141305876|SUPERIORITY||Mean Difference (Final Values)|-8.5||||0.0167|TWO_SIDED|95.0|-15.2|-1.87|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Activities of Daily Living||-1.87|-15.20|0.0167
70908694|NCT01767129|141305876|SUPERIORITY||Mean Difference (Final Values)|-7.5||||0.0959|TWO_SIDED|95.0|-16.54|1.56|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Emotional Well Being||1.56|-16.54|0.0959
70908695|NCT01767129|141305876|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.5108|TWO_SIDED|95.0|-16.72|8.83|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Stigma||8.83|-16.72|0.5108
70908696|NCT01767129|141305876|SUPERIORITY||Mean Difference (Final Values)|-9.8||||0.0806|TWO_SIDED|95.0|-21.06|1.42|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Social support||1.42|-21.06|0.0806
70908697|NCT01767129|141305876|SUPERIORITY||Mean Difference (Final Values)|-4.3||||0.4205|TWO_SIDED|95.0|-15.66|7.03|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Cognitive impairment (Cognitions)||7.03|-15.66|0.4205
70908698|NCT01767129|141305876|SUPERIORITY||Mean Difference (Final Values)|-6.1||||0.1065|TWO_SIDED|95.0|-13.63|1.53|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Communication||1.53|-13.63|0.1065
70908699|NCT01767129|141305876|SUPERIORITY||Mean Difference (Final Values)|-5.2||||0.4456|TWO_SIDED|95.0|-19.51|9.19|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Bodily discomfort||9.19|-19.51|0.4456
70908700|NCT01767129|141305877|SUPERIORITY||Mean Difference (Final Values)|-6.4||||0.0233|TWO_SIDED|95.0|-11.72|-1.07|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||-1.07|-11.72|0.0233
70908701|NCT01767129|141305878|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.193|TWO_SIDED|95.0|-1.39|0.31|||ANOVA|Change from Screening values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||0.31|-1.39|0.1930
70908702|NCT01767129|141305879|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.0511|TWO_SIDED|95.0|-2.17|0.01|||ANOVA|Change were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Dyskinesia||0.01|-2.17|0.0511
70908703|NCT01767129|141305879|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.7745|TWO_SIDED|95.0|-0.7|0.91|||ANOVA|Change were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Other symptoms||0.91|-0.70|0.7745
70908704|NCT03389893|141305880|SUPERIORITY||Geometric Mean Ratio|0.033|||<|0.001|TWO_SIDED|95.0|0.008|0.131|||ANCOVA||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator.|||0.131|0.008|<0.001
70908705|NCT03389893|141305881|SUPERIORITY||Geometric Mean Ratio|0.28||||0.019|TWO_SIDED|95.0|0.09|0.8|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 3||0.80|0.09|0.019
70908706|NCT03389893|141305881|SUPERIORITY||Geometric Mean Ratio|0.37||||0.165|TWO_SIDED|95.0|0.09|1.51|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 7||1.51|0.09|0.165
70908707|NCT03389893|141305881|SUPERIORITY||Geometric Mean Ratio|0.08|||<|0.001|TWO_SIDED|95.0|0.02|0.27|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 14||0.27|0.02|<0.001
70908708|NCT03389893|141305881|SUPERIORITY||Geometric Mean Ratio|0.07|||<|0.001|TWO_SIDED|95.0|0.02|0.25|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 21||0.25|0.02|<0.001
70908709|NCT03389893|141305881|SUPERIORITY||Geometric Mean Ratio|0.16||||0.004|TWO_SIDED|95.0|0.05|0.55|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 42||0.55|0.05|0.004
70908710|NCT03389893|141305881|SUPERIORITY||Geometric Mean Ratio|0.38||||0.216|TWO_SIDED|95.0|0.08|1.8|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 77||1.80|0.08|0.216
70908711|NCT03389893|141305881|SUPERIORITY||Geometric Mean Ratio|0.24||||0.071|TWO_SIDED|95.0|0.05|1.13|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 112||1.13|0.05|0.071
70908712|NCT03389893|141305881|SUPERIORITY||Geometric Mean Ratio|0.34||||0.022|TWO_SIDED|95.0|0.13|0.85|||Mixed Models Analysis||Day 77 is numerator and Day 42 is denominator|Day 77 / Day 42||0.85|0.13|0.022
70908713|NCT03389893|141305881|SUPERIORITY||Geometric Mean Ratio|0.25||||0.015|TWO_SIDED|95.0|0.08|0.76|||Mixed Models Analysis||Day 112 is numerator and Day 42 is denominator|Day 112 / Day 42||0.76|0.08|0.015
70908714|NCT03389893|141305881|SUPERIORITY||Geometric Mean Ratio|0.14|||<|0.001|TWO_SIDED|95.0|0.04|0.41|||Mixed Models Analysis||Day 77 is numerator and Day 42 is denominator|Day 77 / Day 42||0.41|0.04|<0.001
70908715|NCT03389893|141305881|SUPERIORITY||Geometric Mean Ratio|0.16||||0.006|TWO_SIDED|95.0|0.04|0.58|||Mixed Models Analysis||Day 112 is numerator and Day 42 is denominator|Day 112 / Day 42||0.58|0.04|0.006
70908716|NCT03389893|141305882|SUPERIORITY||Geometric Mean Ratio|0.8||||0.724|TWO_SIDED|95.0|0.23|2.82|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 3||2.82|0.23|0.724
70908717|NCT03389893|141305882|SUPERIORITY||Geometric Mean Ratio|0.27||||0.033|TWO_SIDED|95.0|0.08|0.89|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 7||0.89|0.08|0.033
70908718|NCT03389893|141305882|SUPERIORITY||Geometric Mean Ratio|0.36||||0.073|TWO_SIDED|95.0|0.12|1.1|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 14||1.10|0.12|0.073
70908719|NCT03389893|141305882|SUPERIORITY||Geometric Mean Ratio|0.73||||0.579|TWO_SIDED|95.0|0.23|2.29|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 21||2.29|0.23|0.579
70908720|NCT03389893|141305882|SUPERIORITY||Geometric Mean Ratio|0.17||||0.003|TWO_SIDED|95.0|0.05|0.53|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 28||0.53|0.05|0.003
70908721|NCT03389893|141305882|SUPERIORITY||Geometric Mean Ratio|0.52||||0.297|TWO_SIDED|95.0|0.15|1.81|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 42||1.81|0.15|0.297
70908722|NCT03389893|141305882|SUPERIORITY||Geometric Mean Ratio|0.48||||0.326|TWO_SIDED|95.0|0.11|2.12|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 77||2.12|0.11|0.326
70908723|NCT03389893|141305882|SUPERIORITY||Geometric Mean Ratio|0.52||||0.401|TWO_SIDED|95.0|0.11|2.42|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 112||2.42|0.11|0.401
70908724|NCT03389893|141305882|SUPERIORITY||Geometric Mean Ratio|0.81||||0.705|TWO_SIDED|95.0|0.28|2.4|||Mixed Models Analysis||Day 77 is numerator and Day 42 is denominator|Day 77 / Day 42||2.40|0.28|0.705
70908725|NCT03389893|141305882|SUPERIORITY||Geometric Mean Ratio|0.72||||0.538|TWO_SIDED|95.0|0.25|2.08|||Mixed Models Analysis||Day 112 is numerator and Day 42 is denominator|Day 112 / Day 42||2.08|0.25|0.538
70908726|NCT03389893|141305882|SUPERIORITY||Geometric Mean Ratio|0.92||||0.892|TWO_SIDED|95.0|0.25|3.34|||Mixed Models Analysis||Day 77 is numerator and Day 42 is denominator|Day 77 / Day 42||3.34|0.25|0.892
70908727|NCT03389893|141305882|SUPERIORITY||Geometric Mean Ratio|0.74||||0.624|TWO_SIDED|95.0|0.21|2.56|||Mixed Models Analysis||Day 112 is numerator and Day 42 is denominator|Day 112 / Day 42||2.56|0.21|0.624
70908728|NCT03389893|141305883|SUPERIORITY||Mean Difference (Final Values)|-9.53||||0.019|TWO_SIDED|95.0|-17.44|-1.63|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference.)|Day 3, Lesional||-1.63|-17.44|0.019
70908729|NCT03389893|141305883|SUPERIORITY||Mean Difference (Final Values)|-1.08||||0.837|TWO_SIDED|95.0|-11.47|9.32|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 7, Lesional||9.32|-11.47|0.837
71153606|NCT02914301|141799636|OTHER|We compared outcomes between study arms using t-tests for continuous outcomes.|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71153607|NCT00926029|141799733|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70908730|NCT03389893|141305883|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.9|TWO_SIDED|95.0|-6.98|7.92|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 14, Lesional||7.92|-6.98|0.900
70908731|NCT03389893|141305883|SUPERIORITY||Mean Difference (Final Values)|-5.97||||0.13|TWO_SIDED|95.0|-13.76|1.82|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 21, Lesional||1.82|-13.76|0.130
70908732|NCT03389893|141305883|SUPERIORITY||Mean Difference (Final Values)|-7.1||||0.069|TWO_SIDED|95.0|-14.76|0.56|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 28, Lesional||0.56|-14.76|0.069
70908733|NCT03389893|141305883|SUPERIORITY||Mean Difference (Final Values)|-7.99||||0.032|TWO_SIDED|95.0|-15.25|-0.73|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 42, Lesional||-0.73|-15.25|0.032
70908734|NCT03389893|141305883|SUPERIORITY||Mean Difference (Final Values)|-1.05||||0.803|TWO_SIDED|95.0|-9.37|7.28|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 77, Lesional||7.28|-9.37|0.803
70908735|NCT03389893|141305883|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.972|TWO_SIDED|95.0|-9.02|9.34|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 112, Lesional||9.34|-9.02|0.972
70908736|NCT03389893|141305883|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.933|TWO_SIDED|95.0|-6.66|6.12|||Mixed Models Analysis||Day 77 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 77 / Day 42, Lesional||6.12|-6.66|0.933
70908737|NCT03389893|141305883|SUPERIORITY||Mean Difference (Final Values)|-1.82||||0.563|TWO_SIDED|95.0|-8.1|4.45|||Mixed Models Analysis||Day 112 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 112 / Day 42, Lesional||4.45|-8.10|0.563
70908738|NCT03389893|141305883|SUPERIORITY||Mean Difference (Final Values)|-7.08||||0.075|TWO_SIDED|95.0|-14.88|0.73|||Mixed Models Analysis||Day 77 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 77 / Day 42, Lesional||0.73|-14.88|0.075
70908739|NCT03389893|141305883|SUPERIORITY||Mean Difference (Final Values)|-9.84||||0.01|TWO_SIDED|95.0|-17.19|-2.48|||Mixed Models Analysis||Day 112 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 112 / Day 42, Lesional||-2.48|-17.19|0.010
70908740|NCT03389893|141305883|SUPERIORITY||Median Difference (Final Values)|0.69||||0.805|TWO_SIDED|95.0|-4.86|6.23|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 3, Non-lesional||6.23|-4.86|0.805
70908741|NCT03389893|141305883|SUPERIORITY||Mean Difference (Final Values)|2.36||||0.329|TWO_SIDED|95.0|-2.44|7.15|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 7, Non-lesional||7.15|-2.44|0.329
70908742|NCT03389893|141305883|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.97|TWO_SIDED|95.0|-5.39|5.6|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 14, Non-lesional||5.60|-5.39|0.970
70908743|NCT03389893|141305883|SUPERIORITY||Mean Difference (Final Values)|-3.31||||0.18|TWO_SIDED|95.0|-8.18|1.56|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 21, Non-lesional||1.56|-8.18|0.180
70908744|NCT03389893|141305883|SUPERIORITY||Mean Difference (Final Values)|-1.76||||0.342|TWO_SIDED|95.0|-5.45|1.94|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 28, Non-lesional||1.94|-5.45|0.342
71153608|NCT00926029|141799734|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70908745|NCT03389893|141305883|SUPERIORITY||Mean Difference (Final Values)|-2.17||||0.234|TWO_SIDED|95.0|-5.81|1.47|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 42, Non-lesional||1.47|-5.81|0.234
70908746|NCT03389893|141305883|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.316|TWO_SIDED|95.0|-6.27|2.07|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 77, Non-lesional||2.07|-6.27|0.316
70908747|NCT03389893|141305883|SUPERIORITY||Mean Difference (Final Values)|-1.89||||0.276|TWO_SIDED|95.0|-5.37|1.59|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 112, Non-lesional||1.59|-5.37|0.276
70908748|NCT03389893|141305883|SUPERIORITY||Mean Difference (Final Values)|-1.56||||0.237|TWO_SIDED|95.0|-4.19|1.06|||Mixed Models Analysis||Day 77 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 77 / Day 42, Non-lesional||1.06|-4.19|0.237
70908749|NCT03389893|141305883|SUPERIORITY||Mean Difference (Final Values)|-3.03||||0.01|TWO_SIDED|95.0|-5.3|-0.77|||Mixed Models Analysis||Day 112 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 112 / Day 42, Non-lesional||-0.77|-5.30|0.010
70969966|NCT02873936|141445709|SUPERIORITY||Least Squares Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|3.4|<|0.001|TWO_SIDED|95.0|-23.0|-10.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-10.0|-23.0|<0.001
71153609|NCT04154189|141799736|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.0396|TWO_SIDED|95.0|0.27|1.08||One-sided P value|Log Rank||Hazard ratio was based on Cox Proportional Hazard Model including treatment group as a factor and stratified by Age (less than \[\<\]18 years, more than or equal to \[\>=\]18 years) in interactive response technology (IRT). Efron method was used for ties.|||1.08|0.27|0.0396
71153610|NCT04154189|141799737|OTHER|Difference in PFS rates, and 2-sided 95% confidence intervals (CIs): CI and p-value constructed using the difference of the 2 Kaplan-Meier PFS rates (4 months) and the 2 corresponding Greenwood standard errors.|Difference in Percentage|10.2||||0.1683|TWO_SIDED|95.0|-10.6|31.1||One-sided P value|Kaplan-Meier Method|||||31.1|-10.6|0.1683
71153611|NCT04154189|141799739|OTHER||Hazard Ratio (HR)|0.93||||0.3924|TWO_SIDED|95.0|0.53|1.62||Nominal p-value from stratified log-rank test adjusted for the randomization stratification factor, that is, age.|Stratified Log-rank One-sided Test||Hazard ratio was based on a Cox Proportional Hazard Model including treatment group as a factor and stratified by Age (\<18 years, \>=18 years) in IRT. Efron method was used for ties.|||1.62|0.53|0.3924
71153612|NCT04154189|141799740|OTHER|Difference and 95% CI: difference of 2 Kaplan-Meier OS-1y rates and corresponding Greenwood standard errors.|Difference in Percentage|-22.9||||0.0352|TWO_SIDED|95.0|-47.6|1.9||One-sided P value|Kaplan Meier Method|||||1.9|-47.6|0.0352
71153613|NCT04154189|141799741|OTHER|Difference calculated as Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide minus Treatment Arm B: Ifosfamide + Etoposide. 2-sided 95% CI: Miettinen-Nurminen (Score) confidence limits, stratified by randomization stratification factor age (\<18 and \>=18 years).|Difference in Percentage|7.7|||||TWO_SIDED|95.0|-6.4|22.3||||||||22.3|-6.4|
71153614|NCT04154189|141799742|OTHER|Difference calculated as Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide minus Treatment Arm B: Ifosfamide + Etoposide. 2-sided 95% CI: Miettinen-Nurminen (Score) confidence limits, stratified by randomization stratification factor age (\<18 and \>=18 years).|Difference in Percentage|5.2|||||TWO_SIDED|95.0|-10.3|20.0||||||||20.0|-10.3|
71153615|NCT02283762|141799761|SUPERIORITY||Difference of LS means|-2.34||||0.0815|TWO_SIDED|95.0|-4.99|0.3|||MMRM (Method 1)|||||0.30|-4.99|0.0815
71153616|NCT02283762|141799762|SUPERIORITY|The pre-specified test was for superiority but ONLY if the primary endpoint and secondary endpoints were meeting statistical significance (hierarchical testing).|%|0.2||||0.977|TWO_SIDED|95.0|-13.68|14.09|||Mantel Haenszel|||||14.09|-13.68|0.9770
70908750|NCT03389893|141305883|SUPERIORITY||Mean Difference (Final Values)|-0.46||||0.77|TWO_SIDED|95.0|-3.57|2.65|||Mixed Models Analysis||Day 77 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 77 / Day 42, Non-lesional||2.65|-3.57|0.770
70908751|NCT03389893|141305883|SUPERIORITY||Mean Difference (Final Values)|-2.14||||0.117|TWO_SIDED|95.0|-4.84|0.56|||Mixed Models Analysis||Day 112 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 112 / Day 42, Non-lesional||0.56|-4.84|0.117
70908752|NCT03389893|141305884|SUPERIORITY||Mean Difference (Final Values)|85.05||||0.085|TWO_SIDED|95.0|-12.02|182.12|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 7||182.12|-12.02|0.085
70908753|NCT03389893|141305884|SUPERIORITY||Mean Difference (Final Values)|-21.91||||0.733|TWO_SIDED|95.0|-149.13|105.32|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 14||105.32|-149.13|0.733
70908754|NCT03389893|141305884|SUPERIORITY||Mean Difference (Final Values)|-82.5||||0.129|TWO_SIDED|95.0|-189.6|24.61|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 21||24.61|-189.60|0.129
70908755|NCT03389893|141305884|SUPERIORITY||Mean Difference (Final Values)|-92.11||||0.057|TWO_SIDED|95.0|-187.11|2.89|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 28||2.89|-187.11|0.057
70908756|NCT03389893|141305884|SUPERIORITY||Mean Difference (Final Values)|-48.76||||0.242|TWO_SIDED|95.0|-131.52|34.0|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 42||34.00|-131.52|0.242
70908757|NCT03389893|141305884|SUPERIORITY||Mean Difference (Final Values)|-54.37||||0.262|TWO_SIDED|95.0|-150.24|41.49|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 77, Lesional||41.49|-150.24|0.262
70908758|NCT03389893|141305884|SUPERIORITY||Mean Difference (Final Values)|-22.97||||0.546|TWO_SIDED|95.0|-99.79|53.86|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 112||53.86|-99.79|0.546
70908759|NCT03389893|141305884|SUPERIORITY||Mean Difference (Final Values)|-21.8||||0.503|TWO_SIDED|95.0|-86.34|42.75|||Mixed Models Analysis||Day 77 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 77 / Day 42||42.75|-86.34|0.503
70908760|NCT03389893|141305884|SUPERIORITY||Mean Difference (Final Values)|-64.0||||0.034|TWO_SIDED|95.0|-123.01|-4.98|||Mixed Models Analysis||Day 112 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 112 / Day 42||-4.98|-123.01|0.034
70908761|NCT03389893|141305884|SUPERIORITY||Mean Difference (Final Values)|-10.29||||0.789|TWO_SIDED|95.0|-86.63|66.04|||Mixed Models Analysis||Day 77 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 77 / Day 42||66.04|-86.63|0.789
70908762|NCT03389893|141305884|SUPERIORITY||Mean Difference (Final Values)|-83.9||||0.014|TWO_SIDED|95.0|-149.82|-17.98|||Mixed Models Analysis||Day 112 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 112 / Day 42||-17.98|-149.82|0.014
70908763|NCT03389893|141305885|SUPERIORITY||Slope|-0.07||||0.86|TWO_SIDED|95.0|-0.92|0.77|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 7||0.77|-0.92|0.860
70908764|NCT03389893|141305885|SUPERIORITY||Slope|-0.22||||0.488|TWO_SIDED|95.0|-0.85|0.41|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 14||0.41|-0.85|0.488
70908765|NCT03389893|141305885|SUPERIORITY||Slope|-0.55||||0.144|TWO_SIDED|95.0|-1.3|0.2|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 21||0.20|-1.30|0.144
70908766|NCT03389893|141305885|SUPERIORITY||Slope|-0.35||||0.279|TWO_SIDED|95.0|-1.0|0.3|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 28||0.30|-1.00|0.279
70908767|NCT03389893|141305885|SUPERIORITY||Slope|-0.29||||0.461|TWO_SIDED|95.0|-1.09|0.5|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 42||0.50|-1.09|0.461
70908768|NCT03389893|141305885|SUPERIORITY||Slope|-0.27||||0.345|TWO_SIDED|95.0|-0.84|0.3|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 77, Lesional||0.30|-0.84|0.345
70908769|NCT03389893|141305885|SUPERIORITY||Slope|-0.27||||0.275|TWO_SIDED|95.0|-0.77|0.23|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 112||0.23|-0.77|0.275
70908770|NCT01232556|141305907|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.083||||0.708|TWO_SIDED|95.0|0.82|1.44||A one sided 0.025 level testing plan was specified with two interim analyses and final testing level at one-sided 0.023.|Log Rank|From one sided stratified log-rank test.|From stratified Cox proportional hazards model. The stratification factors are are pre-randomization investigator choice, baseline Secondary International Prognostic Index (sIPI), and best response to most recent chemo therapy.|Primary null hypothesis: Equality of survival distributions. Sample size sufficient to have power 0.96 for an experimental/control hazard ratio of 0.6.||1.44|0.82|0.708
70908771|NCT01232556|141305908|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.924||||0.271|TWO_SIDED|95.0|0.72|1.19||An hierarchical testing strategy was specified for OS, PFS and response. PFS could be tested at the 0.023 level if the OS test result were positive. Response could be tested if both the OS and PFS test results were positive.|Log Rank|From one sided stratified log-rank test.|From stratified Cox proportional hazards model. The stratification factors are are pre-randomization investigator choice, baseline sIPI, and best response to most recent chemo therapy.|Second comparison in hierarchical testing strategy was used for power calculation.||1.19|0.72|0.271
70908772|NCT01232556|141305909|SUPERIORITY_OR_OTHER|||||||0.843||||||An hierarchical testing strategy was specified for OS, PFS and response. PFS could be tested at the 0.023 level if the OS test result were positive. Response could be tested if both the OS and PFS test results were positive.|Cochran-Mantel-Haenszel|The stratification factors are pre-randomization investigator choice, baseline sIPI, and best response to most recent chemo therapy.||Third comparison in hierarchical testing strategy was used for power calculation.||||0.843
70908773|NCT01232556|141305910|SUPERIORITY_OR_OTHER|||||||0.714||||||An hierarchical testing strategy was specified for OS, PFS and response. PFS could be tested at the 0.023 level if the OS test result were positive. Response could be tested if both the OS and PFS test results were positive.|Cochran-Mantel-Haenszel|The stratification factors are pre-randomization investigator choice, baseline sIPI, and best response to most recent chemo therapy.||Third comparison in hierarchical testing strategy was used for power calculation.||||0.714
70908774|NCT01232556|141305911|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.142|TWO_SIDED|95.0|0.47|1.25|||Log Rank|From one sided stratified log-rank test.|From stratified Cox proportional hazards model. The stratification factors are pre-randomization investigator choice, baseline sIPI, and best response to most recent chemo therapy.|DOR was not part of the formal hypothesis testing strategy.||1.25|0.47|0.142
70908775|NCT01232556|141305912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.2892|TWO_SIDED|95.0|-0.02|0.06|||Mixed Models Analysis|Repeated measures mixed effects model with treatment, time, treatment-by-time interaction, and baseline as covariate.||||0.06|-0.02|0.2892
70908776|NCT01232556|141305913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.11||||0.1879|TWO_SIDED|95.0|-1.52|7.74|||Mixed Models Analysis|Repeated measures mixed effects model with treatment, time, treatment-by-time interaction, and baseline as covariate.||||7.74|-1.52|0.1879
70908777|NCT01473420|141305918|NON_INFERIORITY_OR_EQUIVALENCE|An equivalence margin of +/- 0.5 was considered relevant to demonstrate the equivalence of the two products.|LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|95.0|-0.17|0.24||||||Least square (LS) mean and 95 percent confidence interval (CI) derived from an analysis of covariance (ANCOVA) model with fixed effect of treatment.||0.24|-0.17|
70908778|NCT01473420|141305919|NON_INFERIORITY_OR_EQUIVALENCE|An equivalence margin of +/- 0.5 was considered relevant to demonstrate the equivalence of the two products.|LS Mean Difference|-2.34|STANDARD_ERROR_OF_MEAN|6.175|||TWO_SIDED|95.0|-14.51|9.82||||||LS mean and 95 percent CI derived from an ANCOVA model with fixed effect of treatment.||9.82|-14.51|
70908779|NCT01473420|141305920|SUPERIORITY_OR_OTHER|||||||0.8338|||||||Two-sample t-test|||||||0.8338
70908780|NCT01473420|141305921|SUPERIORITY_OR_OTHER|||||||0.6895|||||||Wilcoxon Rank Sum test|P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.||||||0.6895
70908781|NCT01473420|141305922|SUPERIORITY_OR_OTHER|||||||0.9177|||||||Wilcoxon Rank Sum test|P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.||||||0.9177
70969967|NCT02873936|141445709|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|3.4|<|0.001|TWO_SIDED|95.0|-19.0|-5.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-19.0|<0.001
70969968|NCT02873936|141445710|SUPERIORITY||Least Squares Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.055|<|0.001|TWO_SIDED|95.0|-0.33|-0.11||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.11|-0.33|<0.001
70969969|NCT02873936|141445710|SUPERIORITY||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.055||0.006|TWO_SIDED|95.0|-0.26|-0.04||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.04|-0.26|0.006
70969970|NCT02873936|141445710|SUPERIORITY||Least Squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.075|<|0.001|TWO_SIDED|95.0|-0.51|-0.21||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.21|-0.51|<0.001
70969971|NCT02873936|141445710|SUPERIORITY||Least Squares Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.075||0.003|TWO_SIDED|95.0|-0.37|-0.08||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.08|-0.37|0.003
70908782|NCT03862482|141305953|EQUIVALENCE|Intraclass Correlation Coefficient (ICC, two-way mixed-effect model) assessed inter- and intra-examiner reliability of bone level measurement on 20 radiographs. Dahlberg measurement error. Two-way, mixed effect model|Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED|95.0|-1.22|-0.49||Bonferroni correction was applied for pairwise comparisons|ANOVA|Repeated measures ANOVA. Dahlberg measurement error||Total 35 Brånemark® implants analyzed for all Configurations. Size difference expected 0.95 bone level change between B/SW/SC. Sample size 16 participants ensured 80% power to reject null hypothesis (two-sided Bonferroni-adjusted α level 0.017, pairwise comparisons between implant groups). Repeated measures ANOVA. Mixed models, repeated measures within subject. Implant type/site/configuration independent variables (length covariate). (B/SW/SC lengths compared with Kruskal-Wallis test)||-0.49|-1.22|<0.05
71153617|NCT02283762|141799763|SUPERIORITY|The pre-specified test was for superiority but ONLY if the primary endpoint and secondary endpoints were meeting statistical significance (hierarchical testing).|Difference in LS means|-0.07||||0.3529|TWO_SIDED|95.0|-0.23|0.08|||MMRM (Method 1)|||change from baseline||0.08|-0.23|0.3529
70969972|NCT02873936|141445711|SUPERIORITY||Least Squares Mean Difference|-10.51|STANDARD_ERROR_OF_MEAN|1.578|<|0.001|TWO_SIDED|95.0|-13.61|-7.41||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.41|-13.61|<0.001
70969973|NCT02873936|141445711|SUPERIORITY||Least Squares Mean Difference|-8.92|STANDARD_ERROR_OF_MEAN|1.577|<|0.001|TWO_SIDED|95.0|-12.02|-5.82||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.82|-12.02|<0.001
70908783|NCT03862482|141305953|EQUIVALENCE|Intraclass Correlation Coefficient (ICC, two-way mixed-effect model) assessed inter- and intra-examiner reliability of bone level measurement on 20 radiographs. Dahlberg measurement error. Two-way, mixed effect model|Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED|95.0|-1.35|-0.64||Bonferroni correction was applied for pairwise comparisons|ANOVA|Repeated measures ANOVA. Dahlberg measurement error||Total 36 Swede-Vent® implants analyzed for all Configurations. Size difference expected 0.95 bone level change between B/SW/SC. Sample size 16 participants ensured 80% power to reject null hypothesis (two-sided Bonferroni-adjusted α level 0.017, pairwise comparisons between implant groups). Repeated measures ANOVA. Mixed models, repeated measures within subject. Implant type/site/configuration independent variables (length covariate). (B/SW/SC lengths compared with Kruskal-Wallis test)||-0.64|-1.35|<0.05
71153618|NCT02283762|141799764|SUPERIORITY|The pre-specified test was for superiority but ONLY if the primary endpoint and secondary endpoints were meeting statistical significance (hierarchical testing).|Difference in LS means|0.79||||0.0887|TWO_SIDED|95.0|-0.12|1.69|||MMRM (Method 1)|||Change from baseline||1.69|-0.12|0.0887
70969974|NCT02873936|141445711|SUPERIORITY||Least Squares Mean Difference|-10.94|STANDARD_ERROR_OF_MEAN|1.652|<|0.001|TWO_SIDED|95.0|-14.19|-7.69||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.69|-14.19|<0.001
70969975|NCT02873936|141445711|SUPERIORITY||Least Squares Mean Difference|-8.98|STANDARD_ERROR_OF_MEAN|1.651|<|0.001|TWO_SIDED|95.0|-12.22|-5.73||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.73|-12.22|<0.001
70969976|NCT02873936|141445711|SUPERIORITY||Least Squares Mean Difference|-9.87|STANDARD_ERROR_OF_MEAN|1.964|<|0.001|TWO_SIDED|95.0|-13.73|-6.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.00|-13.73|<0.001
70969977|NCT02873936|141445711|SUPERIORITY||Least Squares Mean Difference|-6.89|STANDARD_ERROR_OF_MEAN|1.987|<|0.001|TWO_SIDED|95.0|-10.8|-2.98||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.98|-10.80|<0.001
70969978|NCT02873936|141445712|SUPERIORITY||Difference in Response Rates|20.1|||<|0.001|TWO_SIDED|95.0|8.1|32.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4.||32.1|8.1|<0.001
70969979|NCT02873936|141445712|SUPERIORITY||Difference in Response Rates|14.5||||0.013|TWO_SIDED|95.0|2.4|26.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4.||26.5|2.4|0.013
70969980|NCT02873936|141445712|SUPERIORITY||Difference in Response Rates|22.2|||<|0.001|TWO_SIDED|95.0|10.3|34.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12.||34.1|10.3|<0.001
70969981|NCT02873936|141445712|SUPERIORITY||Difference in Response Rates|21.8|||<|0.001|TWO_SIDED|95.0|10.0|33.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12.||33.6|10.0|<0.001
70969982|NCT02873936|141445712|SUPERIORITY||Difference in Response Rates|33.3|||<|0.001|TWO_SIDED|95.0|21.8|44.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24.||44.9|21.8|<0.001
70969983|NCT02873936|141445712|SUPERIORITY||Difference in Response Rates|18.6||||0.001|TWO_SIDED|95.0|6.8|30.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24.||30.5|6.8|0.001
71153619|NCT02283762|141799765|SUPERIORITY|The pre-specified test was for superiority but ONLY if the primary endpoint and secondary endpoints were meeting statistical significance (hierarchical testing).|Difference in LS means|0.83||||0.0241|TWO_SIDED|95.0|0.11|1.54|||MMRM (Method 1)|||Change from baseline||1.54|0.11|0.0241
70969984|NCT02873936|141445713|SUPERIORITY||Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.1|-0.6||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.6|-1.1|<0.001
70969985|NCT02873936|141445713|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-0.9|-0.4||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.4|-0.9|<0.001
70969986|NCT02873936|141445713|SUPERIORITY||Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-1.5|-0.9||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.9|-1.5|<0.001
70969987|NCT02873936|141445713|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-1.3|-0.7||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.7|-1.3|<0.001
70969988|NCT02873936|141445713|SUPERIORITY||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.5|-0.8||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.8|-1.5|<0.001
70969989|NCT02873936|141445713|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.1|-0.4||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.4|-1.1|<0.001
70969990|NCT02873936|141445714|SUPERIORITY||Difference in Response Rates|12.3||||0.004|TWO_SIDED|95.0|3.5|21.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4.||21.2|3.5|0.004
70969991|NCT02873936|141445714|SUPERIORITY||Difference in Response Rates|12.8||||0.003|TWO_SIDED|95.0|4.0|21.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4.||21.5|4.0|0.003
70969992|NCT02873936|141445714|SUPERIORITY||Difference in Response Rates|27.4|||<|0.001|TWO_SIDED|95.0|16.3|38.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24.||38.4|16.3|<0.001
70969993|NCT02873936|141445714|SUPERIORITY||Difference in Response Rates|17.0||||0.001|TWO_SIDED|95.0|6.2|27.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24.||27.7|6.2|0.001
70969994|NCT02873936|141445715|SUPERIORITY||Difference in Response Rates|7.5||||0.012|TWO_SIDED|95.0|1.3|13.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4.||13.7|1.3|0.012
70969995|NCT02873936|141445715|SUPERIORITY||Difference in Response Rates|9.1||||0.006|TWO_SIDED|95.0|2.7|15.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4.||15.5|2.7|0.006
70969996|NCT02873936|141445715|SUPERIORITY||Difference in Response Rates|14.3|||<|0.001|TWO_SIDED|95.0|5.6|23.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12.||23.1|5.6|<0.001
70969997|NCT02873936|141445715|SUPERIORITY||Difference in Response Rates|17.4|||<|0.001|TWO_SIDED|95.0|8.5|26.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12.||26.2|8.5|<0.001
70969998|NCT02873936|141445718|SUPERIORITY||Least Squares Mean Difference|-7.1|STANDARD_ERROR_OF_MEAN|1.47|<|0.001|TWO_SIDED|95.0|-10.0|-4.2||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.2|-10.0|<0.001
70969999|NCT02873936|141445718|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.46|<|0.001|TWO_SIDED|95.0|-7.9|-2.2||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.2|-7.9|<0.001
70970000|NCT02873936|141445718|SUPERIORITY||Least Squares Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|1.56|<|0.001|TWO_SIDED|95.0|-12.6|-6.5||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.5|-12.6|<0.001
70970001|NCT02873936|141445718|SUPERIORITY||Least Squares Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|1.55|<|0.001|TWO_SIDED|95.0|-10.6|-4.5||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.5|-10.6|<0.001
70970002|NCT02873936|141445718|SUPERIORITY||Least Squares Mean Difference|-8.7|STANDARD_ERROR_OF_MEAN|1.64|<|0.001|TWO_SIDED|95.0|-11.9|-5.5||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.5|-11.9|<0.001
71030627|NCT01029353|141569491|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.82, 95% credible interval of (0.65, 1.02).|||
71030628|NCT01029353|141569492|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.89|1.18|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.18|0.89|
70970003|NCT02873936|141445718|SUPERIORITY||Least Squares Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|1.66||0.003|TWO_SIDED|95.0|-8.2|-1.6||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.6|-8.2|0.003
70970004|NCT02873936|141445719|SUPERIORITY||Least Squares Mean Difference|-8.1|STANDARD_ERROR_OF_MEAN|1.52|<|0.001|TWO_SIDED|95.0|-11.1|-5.1||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.1|-11.1|<0.001
70970005|NCT02873936|141445719|SUPERIORITY||Least Squares Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|1.52|<|0.001|TWO_SIDED|95.0|-8.9|-2.9||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.9|-8.9|<0.001
70970006|NCT02873936|141445719|SUPERIORITY||Least Squares Mean Difference|-10.7|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-13.8|-7.5||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.5|-13.8|<0.001
71153620|NCT02283762|141799766|SUPERIORITY|The pre-specified test was for superiority but ONLY if the primary endpoint and secondary endpoints were meeting statistical significance (hierarchical testing).|Difference in LS means|-0.2||||0.901|TWO_SIDED|95.0|-3.4|3.0|||MMRM (Method 1)|||change from baseline||3.00|-3.40|0.9010
71153621|NCT00202878|141799767|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.936||||0.016|TWO_SIDED|95.0|0.887|0.988|||Cox proportional hazard model|Covariates of the stratification factors (EARLY ACS trial, chronic prescription lipid-lowering experience, and high-risk ACS diagnosis) and treatment.|Model includes events from randomization to last study visit.|||0.988|0.887|0.016
71153622|NCT00202878|141799768|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.948||||0.035|TWO_SIDED|95.0|0.903|0.996|||Cox proportional hazard model|Covariates of the stratification factors (EARLY ACS trial, chronic prescription lipid-lowering experience, and high-risk ACS diagnosis) and treatment.|Model includes events from randomization to last study visit.|||0.996|0.903|0.035
71153623|NCT00202878|141799769|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.912||||0.016|TWO_SIDED|95.0|0.847|0.983|||Cox proportional hazard model|Covariates of the stratification factors (EARLY ACS trial, chronic prescription lipid-lowering experience, and high-risk ACS diagnosis) and treatment.|Model includes events from randomization to last study visit.|||0.983|0.847|0.016
71153624|NCT00202878|141799770|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.945||||0.035|TWO_SIDED|95.0|0.897|0.996|||Cox proportional hazard model|Covariates of the stratification factors (EARLY ACS trial, chronic prescription lipid-lowering experience, and high-risk ACS diagnosis) and treatment|Model includes events from randomization to last study visit.|||0.996|0.897|0.035
71153625|NCT02028208|141799771|OTHER|Concordance between 0.40 mg/cm2 mercury and 1.0% ammoniated mercury in petrolatum|Kappa statistic|0.38|||||TWO_SIDED|95.0|0.08|0.67||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.67|0.08|
70970007|NCT02873936|141445719|SUPERIORITY||Least Squares Mean Difference|-8.7|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|95.0|-11.8|-5.5||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.5|-11.8|<0.001
70970008|NCT02873936|141445719|SUPERIORITY||Least Squares Mean Difference|-10.1|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-13.5|-6.8||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.8|-13.5|<0.001
71030629|NCT01029353|141569492|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.98, 95% credible interval of (0.84, 1.15).|||
71153626|NCT02028208|141799771|OTHER|Concordance between 0.40 mercury and 0.5% elemental mercury in petrolatum|Kappa statistic|0.67|||||TWO_SIDED|95.0|0.35|0.99||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.99|0.35|
71153627|NCT02028208|141799771|OTHER|Concordance between 0.36 mg/cm2 mercury and 1.0% ammoniated mercury in petrolatum|Kappa statistic|0.46|||||TWO_SIDED|95.0|0.15|0.76||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.76|0.15|
71153628|NCT02028208|141799771|OTHER|Concordance between 0.36 mg/cm2 mercury and 0.5% elemental mercury in petrolatum|Kappa statistic|0.57|||||TWO_SIDED|95.0|0.21|0.93||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.93|0.21|
70908784|NCT03862482|141305953|EQUIVALENCE|Intraclass Correlation Coefficient (ICC, two-way mixed-effect model) assessed inter- and intra-examiner reliability of bone level measurement on 20 radiographs. Dahlberg measurement error. Two-way, mixed effect model|Median Difference (Final Values)|-1.77|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED|95.0|-2.13|-1.41||Bonferroni correction was applied for pairwise comparisons|ANOVA|Repeated measures ANOVA. Dahlberg measurement error||Total 36 Screw-Vent® implants analyzed for all Configurations. Size difference expected 0.95 bone level change between B/SW/SC. Sample size 16 participants ensured 80% power to reject null hypothesis (two-sided Bonferroni-adjusted α level 0.017, pairwise comparisons between implant groups). Repeated measures ANOVA. Mixed models, repeated measures within subject. Implant type/site/configuration independent variables (length covariate). (B/SW/SC lengths compared with Kruskal-Wallis test)||-1.41|-2.13|<0.05
70908785|NCT03259373|141305964|SUPERIORITY||Odds Ratio (OR)|1.01|STANDARD_ERROR_OF_MEAN|0.031||0.79|TWO_SIDED|95.0|0.95|1.07|||fixed-effect meta-analysis|||The null hypothesis was the that proportions of patients with at least one OAC filled at one year were the same between the two groups.||1.07|0.95|0.79
70908786|NCT03259373|141305964|SUPERIORITY||Odds Ratio (OR)|1.04|STANDARD_ERROR_OF_MEAN|0.039||0.307|TWO_SIDED|95.0|0.96|1.12|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled at 183 days were the same between the two groups.||1.12|0.96|0.307
70908787|NCT03259373|141305964|SUPERIORITY||Odds Ratio (OR)|1.05|STANDARD_ERROR_OF_MEAN|0.052||0.375|TWO_SIDED|95.0|0.95|1.16|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled at 90 days were the same between the two groups.||1.16|0.95|0.375
70908788|NCT03259373|141305964|SUPERIORITY||Odds Ratio (OR)|1.09|STANDARD_ERROR_OF_MEAN|0.076||0.265|TWO_SIDED|95.0|0.94|1.26|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled at 42 days were the same between the two groups.||1.26|0.94|0.265
70908789|NCT03259373|141305964|SUPERIORITY||Odds Ratio (OR)|1.05|STANDARD_ERROR_OF_MEAN|0.044||0.237|TWO_SIDED|95.0|0.97|1.15|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among females were the same between the two groups.||1.15|0.97|0.237
70908790|NCT03259373|141305964|SUPERIORITY||Odds Ratio (OR)|0.97|STANDARD_ERROR_OF_MEAN|0.042||0.487|TWO_SIDED|95.0|0.89|1.05|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among males were the same between the two groups.||1.05|0.89|0.487
70908791|NCT03259373|141305964|SUPERIORITY||Odds Ratio (OR)|0.99|STANDARD_ERROR_OF_MEAN|0.125||0.952|TWO_SIDED|95.0|0.78|1.27|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among age \<= 64 yrs were the same between the two groups.||1.27|0.78|0.952
70908792|NCT03259373|141305964|SUPERIORITY||Odds Ratio (OR)|1.02|STANDARD_ERROR_OF_MEAN|0.057||0.696|TWO_SIDED|95.0|0.91|1.14|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of the patients with at least one OAC filled among age 65 - 74 yrs were the same between the two groups.||1.14|0.91|0.696
70908793|NCT03259373|141305964|SUPERIORITY||Odds Ratio (OR)|1.03|STANDARD_ERROR_OF_MEAN|0.047||0.584|TWO_SIDED|95.0|0.94|1.13|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among age 75 - 84 yrs were the same between groups.||1.13|0.94|0.584
70908794|NCT03259373|141305964|SUPERIORITY||Odds Ratio (OR)|0.99|STANDARD_ERROR_OF_MEAN|0.069||0.911|TWO_SIDED|95.0|0.87|1.14|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among age \>= 85 yrs were the same between the two groups.||1.14|0.87|0.911
70908795|NCT03259373|141305964|SUPERIORITY||Odds Ratio (OR)|0.98|STANDARD_ERROR_OF_MEAN|0.057||0.746|TWO_SIDED|95.0|0.88|1.1|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of the patients with at least one OAC filled among those with a CHADS-VASC of 2-3 were the same between the two groups.||1.10|0.88|0.746
70908796|NCT03259373|141305964|SUPERIORITY||Odds Ratio (OR)|1.08|STANDARD_ERROR_OF_MEAN|0.048||0.109|TWO_SIDED|95.0|0.98|1.19|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among those with a CHADS-VASC score of 4-5 were the same between the two groups.||1.19|0.98|0.109
70908797|NCT03259373|141305964|SUPERIORITY||Odds Ratio (OR)|0.94|STANDARD_ERROR_OF_MEAN|0.057||0.244|TWO_SIDED|95.0|0.84|1.05|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among those with a CHADS-VASC score \>=6 were the same between the two groups.||1.05|0.84|0.244
70908798|NCT03259373|141305965|SUPERIORITY||Hazard Ratio (HR)|0.92|STANDARD_ERROR_OF_MEAN|0.079||0.3|TWO_SIDED|95.0|0.79|1.08|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.08|0.79|0.300
70908799|NCT03259373|141305966|SUPERIORITY||Hazard Ratio (HR)|1.31|STANDARD_ERROR_OF_MEAN|0.172||0.122|TWO_SIDED|95.0|0.93|1.83|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.83|0.93|0.122
70908800|NCT03259373|141305967|SUPERIORITY||Hazard Ratio (HR)|0.98|STANDARD_ERROR_OF_MEAN|0.073||0.76|TWO_SIDED|95.0|0.85|1.13|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.13|0.85|0.760
70908801|NCT03259373|141305968|SUPERIORITY||Hazard Ratio (HR)|0.99|STANDARD_ERROR_OF_MEAN|0.072||0.76|TWO_SIDED|95.0|0.86|1.14|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.14|0.86|0.760
70908802|NCT03259373|141305969|SUPERIORITY||Hazard Ratio (HR)|0.97|STANDARD_ERROR_OF_MEAN|0.052||0.616|TWO_SIDED|95.0|0.88|1.08|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.08|0.88|0.616
70908803|NCT03259373|141305970|SUPERIORITY||Hazard Ratio (HR)|1.0|STANDARD_ERROR_OF_MEAN|0.072||0.992|TWO_SIDED|95.0|0.87|1.15|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.15|0.87|0.992
70908804|NCT03259373|141305971|SUPERIORITY||Hazard Ratio (HR)|1.01|STANDARD_ERROR_OF_MEAN|0.029||0.808|TWO_SIDED|95.0|0.95|1.07|||fixed-effect meta-analysis|||||1.07|0.95|0.808
70908805|NCT03259373|141305972|SUPERIORITY||Standardized Mean Difference (%)|-0.51|STANDARD_ERROR_OF_MEAN|0.027||0.853|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.853
70908806|NCT03259373|141305973|SUPERIORITY||Odds Ratio (OR)|0.93|STANDARD_ERROR_OF_MEAN|0.066||0.303|TWO_SIDED|95.0|0.82|1.06|||fixed-effect meta-analysis|||||1.06|0.82|0.303
70908807|NCT03259373|141305974|SUPERIORITY||Hazard Ratio (HR)|1.03|STANDARD_ERROR_OF_MEAN|0.063||0.649|TWO_SIDED|95.0|0.91|1.16|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.16|0.91|0.649
70908808|NCT03259373|141305975|SUPERIORITY||Standardized Mean Difference (%)|-0.4998|STANDARD_ERROR_OF_MEAN|0.009||0.587|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.587
70908809|NCT03259373|141305975|SUPERIORITY||Standardized Mean Difference (%)|-0.4655|STANDARD_ERROR_OF_MEAN|0.009||0.613|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.613
70908810|NCT03259373|141305975|SUPERIORITY||Standardized Mean Difference (%)|0.598|STANDARD_ERROR_OF_MEAN|0.009||0.515|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.515
70908811|NCT03259373|141305975|SUPERIORITY||Standardized Mean Difference (%)|-2.17|STANDARD_ERROR_OF_MEAN|0.009||0.018|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.018
70908812|NCT03259373|141305975|SUPERIORITY||Standardized Mean Difference (%)|0.05|STANDARD_ERROR_OF_MEAN|0.009||0.956|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.956
70908813|NCT03259373|141305976|SUPERIORITY||Standardized Mean Difference (%)|-1.018|STANDARD_ERROR_OF_MEAN|0.009||0.279|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.279
70908814|NCT03259373|141305976|SUPERIORITY||Standardized Mean Difference (%)|-1.347|STANDARD_ERROR_OF_MEAN|0.009||0.143|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.143
70908815|NCT00950937|141306032|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.||||||<0.05
70908816|NCT00950937|141306032|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
70908817|NCT00950937|141306032|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
70908818|NCT00950937|141306033|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.||||||<0.05
70908819|NCT00950937|141306033|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
70908820|NCT00950937|141306033|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
70908821|NCT00950937|141306034|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.||||||<0.05
70908822|NCT00950937|141306034|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
70908823|NCT00950937|141306034|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
70908824|NCT00950937|141306035|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.||||||<0.05
70908825|NCT00950937|141306035|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
70908826|NCT00950937|141306035|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
70908827|NCT00950937|141306036|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.||||||<0.05
70908828|NCT00950937|141306036|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
70908829|NCT00950937|141306036|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
70908830|NCT00950937|141306037|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.||||||<0.05
70908831|NCT00950937|141306037|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
70908832|NCT00950937|141306037|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
70908833|NCT00950937|141306038|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|Paired t-test was utilized to compare the two groups (HIV group and Control group)||||||<0.05
70908834|NCT01474512|141306095|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
70908835|NCT01474512|141306095|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
70908836|NCT01474512|141306096|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
70908837|NCT01474512|141306096|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
70908838|NCT01474512|141306097|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|Due to the zero count in placebo group, p-values from Logistic Regression were not obtainable, therefore the p-value is from Fisher's exact test.||||||<0.001
70908839|NCT01474512|141306097|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|Due to the zero count in placebo group, p-values from Logistic Regression were not obtainable, therefore the p-value is from Fisher's exact test.||||||<0.001
70908840|NCT01474512|141306098|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PASI90.|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
70908841|NCT01474512|141306098|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PASI90.|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
70908842|NCT01474512|141306098|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PASI100.|Fisher Exact|Due to the zero count in placebo group, p-values from Logistic Regression were not obtainable; therefore the p-value is from Fisher's exact test.||||||<0.001
70908843|NCT01474512|141306098|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PASI100.|Fisher Exact|Due to the zero count in placebo group, p-values from Logistic Regression were not obtainable; therefore the p-value is from Fisher's exact test.||||||<0.001
70908844|NCT01474512|141306099|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment and baseline weight category as factors.||||||<0.001
70908845|NCT01474512|141306099|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment and baseline weight category as factors.||||||<0.001
70908846|NCT01474512|141306100|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
70908847|NCT01474512|141306100|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
70908848|NCT01474512|141306101|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
70908849|NCT01474512|141306101|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
71030630|NCT01029353|141569493|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.64|1.31|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.31|0.64|
71153629|NCT02028208|141799771|OTHER|Concordance between 0.10 mg/cm2 palladium and 3.0% sodium tetrachloropalladate in petrolatum|Kappa statistic|0.48|||||TWO_SIDED|95.0|0.05|0.9||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.90|0.05|
70908850|NCT01474512|141306102|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
70908851|NCT01474512|141306102|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
70908852|NCT01474512|141306103|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
70908853|NCT01474512|141306103|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
70908854|NCT01474512|141306104|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
70908855|NCT01474512|141306104|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
70908856|NCT01474512|141306105|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for Absenteeism.||||||<0.001
70908857|NCT01474512|141306105|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for absenteeism.||||||0.003
70908858|NCT01474512|141306105|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for activity impairment.||||||<0.001
70908859|NCT01474512|141306105|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for activity impairment.||||||<0.001
70908860|NCT01474512|141306105|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for presenteeism.||||||<0.001
70908861|NCT01474512|141306105|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for presenteeism.||||||<0.001
70908862|NCT01474512|141306105|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for work productively loss.||||||<0.001
70908863|NCT01474512|141306105|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for work productively loss.||||||<0.001
70908864|NCT01474512|141306106|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS Mean and p-values were calculated using an ANCOVA model that included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline QIDS value in the model.|ANCOVA|||||||<0.001
70908865|NCT01474512|141306106|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS Mean and p-values were calculated using an ANCOVA model that included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline QIDS value in the model.|ANCOVA|||||||<0.001
70908866|NCT01474512|141306107|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline SF-36 value in the model.|ANCOVA|P-value is for PCS.||||||<0.001
70908867|NCT01474512|141306107|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline SF-36 value in the model.|ANCOVA|P-value is for PCS.||||||<0.001
70908868|NCT01474512|141306107|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline SF-36 value in the model.|ANCOVA|P-value is for MCS.||||||<0.001
70908869|NCT01474512|141306107|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline SF-36 value in the model.|ANCOVA|P-value is for MCS.||||||<0.001
70908870|NCT01474512|141306108|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
70908871|NCT01474512|141306108|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
70908872|NCT01474512|141306109|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PPASI50.|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
70908873|NCT01474512|141306109|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PPASI50.|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
70908874|NCT01474512|141306109|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PPASI75|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
70908875|NCT01474512|141306109|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PPASI75|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
70908876|NCT01474512|141306109|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PPASI100|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
70908877|NCT01474512|141306109|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value if for PPASI100.|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
70908878|NCT03123263|141306146|OTHER|Repeated measures one sided ANOVA was used to analyze changes in ejection fraction over time.|||||<|0.0005|||||||ANOVA|F (2,98) =13.974||||||<0.0005
70908879|NCT00906503|141306196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3|STANDARD_DEVIATION|1.6|||TWO_SIDED|95.0|0.06|31.1||||||||31.1|0.06|
70908880|NCT00479037|141306197|SUPERIORITY_OR_OTHER||Mean Difference (Net)|360.3|||<|0.0001|TWO_SIDED|95.0|256.5|494.3||P-values corresponding to the tests of treatment effect for the primary endpoints were adjusted using the Hochberg procedure.|ANCOVA|||The bone marker values were log-transformed for the primary analysis as they were heavily skewed. Changes in log-transformed bone marker values were analyzed using an analysis of covariance (ANCOVA) with treatment and center as fixed effects and the baseline bone marker value as a covariate. An F-test was used to test the effect of treatment and the least square means were computed to assess the clinical difference between treatment groups.||494.3|256.5|<0.0001
70908881|NCT00479037|141306198|SUPERIORITY_OR_OTHER||Mean Difference (Net)|92.9|||<|0.0001|TWO_SIDED|95.0|63.8|127.1||P-values corresponding to the tests of treatment effect for the primary endpoints were adjusted using the Hochberg procedure.|ANCOVA|||The bone marker values were log-transformed for the primary analysis as they were heavily skewed. Changes in log-transformed bone marker values were analyzed using an analysis of covariance (ANCOVA) with treatment and center as fixed effects and the baseline bone marker value as a covariate. An F-test was used to test the effect of treatment and the least square means were computed to assess the clinical difference between treatment groups.||127.1|63.8|<0.0001
70908882|NCT00479037|141306199|SUPERIORITY_OR_OTHER||Mean Difference (Net)|138.5|||<|0.0001|TWO_SIDED|95.0|94.8|191.8||P-value corresponding to the tests of treatment effect was adjusted using the Hochberg procedure.|ANCOVA|||The bone marker values were log-transformed for the primary analysis as they were heavily skewed. Changes in log-transformed bone marker values were analyzed using an analysis of covariance (ANCOVA) with treatment and center as fixed effects and the baseline bone marker value as a covariate. An F-test was used to test the effect of treatment and the least square means were computed to assess the clinical difference between treatment groups.||191.8|94.8|<0.0001
70908883|NCT03220737|141306245|NON_INFERIORITY|This analysis was based on the lower confidence limit and did not entail a comparative group. The requirement was for the lower limit of the 98.3% CI be at least 70%. Multiplicity adjustment due to co-primary endpoints allotted alpha=0.017 to this endpoint resulting in a 98.3% confidence interval|Proportion|0.985|||||ONE_SIDED|98.3|0.7||||||||||0.7|
70908884|NCT03220737|141306246|NON_INFERIORITY|This analysis was based on the lower confidence limit and did not entail a comparative group. The requirement was for the lower limit of the 98.3% CI be at least 70%. Multiplicity adjustment due to coprimary endpoints allotted alpha=0.017 to this endpoint resulting in a 98.3% confidence interval.|Proportion|0.985|||||ONE_SIDED|98.3|0.7||||||||||0.7|
70908885|NCT03220737|141306247|NON_INFERIORITY|This analysis was based on the lower confidence limit and did not entail a comparative group. The requirement was for the lower limit of the 98.3% CI be at least 70%. Multiplicity adjustment due to coprimary endpoints allotted alpha=0.017 to this endpoint resulting in a 98.3% confidence interval.|Proportion|0.985|||||ONE_SIDED|98.3|0.7||||||||||0.7|
70908886|NCT03220737|141306248|NON_INFERIORITY|Non-inferiority was determined using the Newcombe method of determining the difference between two independent binomial distributions. Multiple comparison adjustment for co-primary endpoints allotted alpha=0.033 to this comparison. The lower limit of the 96.7% CI needed to be greater than -10 percentage points to prove non-inferiority.|Risk Difference (RD)|5.8|||||TWO_SIDED|96.7|2.4|7.1|||||Newcombe method of determining the difference between two independent binomial distributions|||7.1|2.4|
70908887|NCT03220737|141306249|NON_INFERIORITY|Non-inferiority was determined using the Newcombe method of determining the difference between two independent binomial distributions. Multiple comparison adjustment for co-primary endpoints allotted alpha=0.033 to this comparison. The lower limit of the 96.7% CI needed to be greater than -10 percentage points to prove non-inferiority.|Risk Difference (RD)|4.3|||||TWO_SIDED|96.7|-0.3|6.2||||||||6.2|-0.3|
70908888|NCT03220737|141306250|NON_INFERIORITY|Non-inferiority was determined using the Newcombe method of determining the difference between two independent binomial distributions. Multiple comparison adjustment for co-primary endpoints allotted alpha=0.033 to this comparison. The lower limit of the 96.7% CI needed to be greater than -10 percentage points to prove non-inferiority.|Risk Difference (RD)|4.5|||||TWO_SIDED|96.7|-1.1|6.4||||||||6.4|-1.1|
70908889|NCT03220737|141306251|SUPERIORITY|Fisher's exact test was used to compare Vaxchora vaccine to placebo on the percent of subjects who seroconverted. For Vaxchora vs placebo within each cohort at each Day on study timepoint, the p-value was the same (p\<0.0001).|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
70908890|NCT03220737|141306252|SUPERIORITY|Fisher's exact test was used to compare Vaxchora vaccine to placebo on the percent of subjects who seroconverted. For Vaxchora vs placebo within each cohort at each Day on study timepoint, the p-value was the same (p\<0.0001).|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
70908891|NCT03220737|141306253|SUPERIORITY|Fisher's exact test was used to compare Vaxchora vaccine to placebo on the percent of subjects who seroconverted. For Vaxchora vs placebo within each cohort at each Day on study timepoint, the p-value was the same (p\<0.0001).|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
70908892|NCT03220737|141306257|SUPERIORITY|Fisher's exact test was used to compare Vaxchora vaccine to placebo on the percent of subjects who seroconverted. For Vaxchora vs placebo within each cohort at each Day on study timepoint, the p-value was the same (p\<0.0001).|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
70908893|NCT03220737|141306258|SUPERIORITY|Fisher's exact test was used to compare Vaxchora vaccine to placebo on the percent of subjects who seroconverted. For Vaxchora vs placebo within each cohort at each Day on study timepoint, the p-value was the same (p\<0.0001).|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71153630|NCT02028208|141799771|OTHER|Concordance between 0.10 mg/cm2 palladium and 1.0% palladium chloride in petrolatum|Kappa statistic|0.39|||||TWO_SIDED|95.0|0.1|0.68||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.68|0.10|
70908894|NCT00684983|141306275|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04||||0.89|TWO_SIDED|95.0|0.58|1.89|||Regression, Cox|||Analysis of the primary endpoint, PFS, will be performed using Cox regression with treatment group as a single covariate.||1.89|0.58|.89
70908895|NCT00684983|141306276|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.93|TWO_SIDED|95.0|0.5|3.0|||Log Rank|||||3|0.5|0.93
70908896|NCT00684983|141306277|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.66|TWO_SIDED|95.0|0.53|1.92|||Log Rank|||||1.92|.53|.66
70908897|NCT00684983|141306279|SUPERIORITY||Hazard Ratio (HR)|0.39||||0.26|TWO_SIDED|95.0|0.09|1.53|||Log Rank|||||1.53|.09|.26
70908898|NCT00594932|141306295|SUPERIORITY_OR_OTHER_LEGACY||superiority|4.0|||=|0.041||||||This was the primary endpoint therefore no adjustment for multiple comparisons was necessary|Fisher Exact|||this is a categorical assessment. Prespecified. Fishers exact test. Significant is calculated as \< 0.05||||=0.041
70908899|NCT00918749|141306301|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.598|STANDARD_ERROR_OF_MEAN|4.215||0.3946|TWO_SIDED|90.0|-10.568|3.372|||ANOVA|Fixed effects for treatment and center.||A two group t-test with a 0.100 one-sided significance level would have 96% power to detect the difference between a risedronate 150 mg IRBB mean, µ1, of -46.000 and a risedronate 75 mg DRFB mean, µ2, of -29.900 (a difference in means of -16.100), assuming that the common SD was 28.000, with sample sizes of 60 per group, respectively. Estimates were based on Study 2005107 (35 mg DR once a week Phase 2 study). The sample size calculation was not adjusted for multiplicity.||3.372|-10.568|0.3946
70908900|NCT00918749|141306301|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.197|STANDARD_ERROR_OF_MEAN|4.241||0.0045|TWO_SIDED|90.0|-19.208|-5.185|||ANOVA|Fixed effects for treatment and center.||||-5.185|-19.208|0.0045
70908901|NCT00918749|141306302|SUPERIORITY_OR_OTHER||LS Mean Difference|4.765|STANDARD_ERROR_OF_MEAN|4.952||0.3372|TWO_SIDED|90.0|-3.421|12.952|||ANOVA|Fixed effects for treatment and center.||||12.952|-3.421|0.3372
70908902|NCT00918749|141306302|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.218|STANDARD_ERROR_OF_MEAN|4.966||0.965|TWO_SIDED|90.0|-8.427|7.991|||ANOVA|Fixed effects for treatment and center.||||7.991|-8.427|0.9650
70908903|NCT00918749|141306303|SUPERIORITY_OR_OTHER||LS Mean Difference|0.388|STANDARD_ERROR_OF_MEAN|4.269||0.9276|TWO_SIDED|90.0|-6.67|7.447|||ANOVA|Fixed effects for treatment and center.||||7.447|-6.670|0.9276
70908904|NCT00918749|141306303|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.787|STANDARD_ERROR_OF_MEAN|4.313||0.0133|TWO_SIDED|90.0|-17.917|-3.657|||ANOVA|Fixed effects for treatment and center.||||-3.657|-17.917|0.0133
71153631|NCT02028208|141799771|OTHER||Kappa statistic|0.83|||||TWO_SIDED|95.0|0.5|1.0||||||Concordance between 0.30 mg/cm2 palladium and 3.0% sodium tetrachloropalladate in petrolatum||1.00|0.50|
70908905|NCT00918749|141306304|SUPERIORITY_OR_OTHER||LS Mean Difference|14.528|STANDARD_ERROR_OF_MEAN|9.28||0.1192|TWO_SIDED|90.0|-0.813|29.868|||ANOVA|Fixed effects for treatment and center.||||29.868|-0.813|0.1192
70908906|NCT00918749|141306304|SUPERIORITY_OR_OTHER||LS Mean Difference|14.215|STANDARD_ERROR_OF_MEAN|9.343||0.1298|TWO_SIDED|90.0|-1.23|29.659|||ANOVA|Fixed effects for treatment and center.||||29.659|-1.230|0.1298
70908907|NCT00918749|141306305|SUPERIORITY_OR_OTHER||LS Mean Difference|1.119|STANDARD_ERROR_OF_MEAN|6.093||0.8546|TWO_SIDED|90.0|-8.956|11.193|||ANOVA|Fixed effects for treatment and center.||||11.193|-8.956|0.8546
70908908|NCT00918749|141306305|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.393|STANDARD_ERROR_OF_MEAN|6.126||0.2291|TWO_SIDED|90.0|-17.522|2.737|||ANOVA|Fixed effects for treatment and center.||||2.737|-17.522|0.2291
70908909|NCT00918749|141306306|SUPERIORITY_OR_OTHER||LS Mean Difference|5.505|STANDARD_ERROR_OF_MEAN|9.046||0.5436|TWO_SIDED|90.0|-9.452|20.462|||ANOVA|Fixed effects for treatment and center.||||20.462|-9.452|0.5436
70908910|NCT00918749|141306306|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.914|STANDARD_ERROR_OF_MEAN|9.1||0.9201|TWO_SIDED|90.0|-15.959|14.132|||ANOVA|Fixed effects for treatment and center.||||14.132|-15.959|0.9201
70908911|NCT00918749|141306307|SUPERIORITY_OR_OTHER||LS Mean Difference|3.108|STANDARD_ERROR_OF_MEAN|4.052||0.444|TWO_SIDED|90.0|-3.59|9.807|||ANOVA|Fixed effects for treatment and center.||||9.807|-3.590|0.4440
70908912|NCT00918749|141306307|SUPERIORITY_OR_OTHER||LS Mean Difference|4.842|STANDARD_ERROR_OF_MEAN|4.063||0.2349|TWO_SIDED|90.0|-1.874|11.559|||ANOVA|Fixed effects for treatment and center.||||11.559|-1.874|0.2349
70908913|NCT00918749|141306308|SUPERIORITY_OR_OTHER||LS Mean Difference|4.966|STANDARD_ERROR_OF_MEAN|4.327||0.2527|TWO_SIDED|90.0|-2.189|12.12|||ANOVA|Fixed effects for treatment and center.||||12.120|-2.189|0.2527
70908914|NCT00918749|141306308|SUPERIORITY_OR_OTHER||LS Mean Difference|4.926|STANDARD_ERROR_OF_MEAN|4.371||0.2613|TWO_SIDED|90.0|-2.301|12.153|||ANOVA|Fixed effects for treatment and center.||||12.153|-2.301|0.2613
70908915|NCT00918749|141306309|SUPERIORITY_OR_OTHER||LS Mean Difference|1.269|STANDARD_ERROR_OF_MEAN|4.16||0.7606|TWO_SIDED|90.0|-5.609|8.148|||ANOVA|Fixed effects for treatment and center.||||8.148|-5.609|0.7606
70908916|NCT00918749|141306309|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.825|STANDARD_ERROR_OF_MEAN|4.185||0.5006|TWO_SIDED|90.0|-9.744|4.095|||ANOVA|Fixed effects for treatment and center.||||4.095|-9.744|0.5006
70908917|NCT03055832|141306330|NON_INFERIORITY|"This study provides a combined power of co-primary endpoints of 88% given the following primary endpoint assumptions:~* MGS non-inferiority delta of 5 points and standard deviation of 8 points provides power of 93.9%~* TBT non-inferiority delta of 2.5 seconds and standard deviation of 4 seconds, provides a TBT primary endpoint power of 93.9%~* Power that both endpoitns are significant, assuming independence was 0.939\^2 = 0.882 or 88.2% power."|Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|1.88|||TWO_SIDED|95.0|-3.82|3.56||||||||3.56|-3.82|
70908918|NCT03055832|141306331|NON_INFERIORITY|"This study provides a combined power of co-primary endpoints of 88% given the following primary endpoint assumptions:~* MGS non-inferiority delta of 5 points and standard deviation of 8 points provides power of 93.9%~* TBT non-inferiority delta of 2.5 seconds and standard deviation of 4 seconds, provides a TBT primary endpoint power of 93.9%~* Power that both endpoitns are significant, assuming independence was 0.939\^2 = 0.882 or 88.2% power."|Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-0.97|1.16||||||||1.16|-0.97|
70908919|NCT03055832|141306332|OTHER|A formal hypothesis was not proposed for this endpoint and therefore a power calculation was not performed. A Fisher's Exact test was performed post hoc to determine if a significant difference existed between the two arms.||||||0.12|||||||Fisher Exact|||||||0.12
71153632|NCT02028208|141799771|OTHER|Concordance between 0.30 mg/cm2 palladium and 1.0% palladium chloride in petrolatum|Kappa statistic|0.19|||||TWO_SIDED|95.0|-0.02|0.39||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.39|-0.02|
71030631|NCT01029353|141569493|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.86, 95% credible interval of (0.64, 1.16).|||
71030632|NCT01029353|141569494|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.69|1.36|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.36|0.69|
71030633|NCT01029353|141569494|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.92, 95% credible interval of (0.68, 1.25).|||
71030634|NCT01029353|141569495|SUPERIORITY||Risk Ratio (RR)|0.47|||||TWO_SIDED|95.0|0.35|0.63|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||0.63|0.35|
71030635|NCT01029353|141569495|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.51, 95% credible interval of (0.37, 0.69).|||
71030636|NCT01029353|141569496|SUPERIORITY||Risk Ratio (RR)|1.57|||||TWO_SIDED|95.0|1.04|2.36|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||2.36|1.04|
71030637|NCT01029353|141569496|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.45, 95% credible interval of (0.92, 2.31).|||
71030638|NCT01029353|141569497|SUPERIORITY||Risk Ratio (RR)|1.58|||||TWO_SIDED|95.0|0.71|3.5|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||3.50|0.71|
71030639|NCT01029353|141569497|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.31, 95% credible interval of (0.66, 2.62).|||
71030640|NCT01029353|141569498|SUPERIORITY|||||||||||||||||A frequentist analysis.|This analysis used model identical to other by treatment analyses for binary outcome. RR estimated from robust Poisson regression with log link, reference cell coding, center as repeated measure. RR: Initial Laparotomy over Peritoneal Drain. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates. However, adjusted RR estimates could not be calculated due to the iteration limit being excessed in PROC GENMOD.|||
71153633|NCT02028208|141799771|OTHER|Concordance between 0.60 mg/cm2 palladium and 3.0% sodium tetrachloropalladate in petrolatum|Kappa statistic|0.83|||||TWO_SIDED|95.0|0.5|1.0||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||1.00|0.50|
71153634|NCT02028208|141799771|OTHER||Kappa statistic|0.06|||||TWO_SIDED|95.0|-0.05|0.17||||Concordance between 0.60 mg/cm2 palladium and 1.0 palladium chloride in petrolatum||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.17|-0.05|
70908920|NCT03055832|141306333|NON_INFERIORITY|A standard deviation of 14 was assumed based on pilot data and the non-inferiority delta was set to 7. The chosen sample size and alpha = 0.025 provides 80% power for this endpoint|Mean Difference (Net)|-3.08|STANDARD_ERROR_OF_MEAN|2.89|||TWO_SIDED|95.0|-8.75|2.59||||||All questions||2.59|-8.75|
71153635|NCT03563183|141799776|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the confimed herpes zoster for Herpes Zoster subunit vaccine Group compared to Placebo Group.|Vaccine Efficacy rate|95.81|||<|0.0001|TWO_SIDED|95.0|91.58|98.22|||Poisson exact test|||Efficacy analysis aimed at comparing the confimed herpes zoster for Herpes Zoster incidence rate between Non-Frail-HZ/su vs Non-Frail-Placebo groups.||98.22|91.58|<0.0001
70908921|NCT01152554|141306342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.24||0.697|TWO_SIDED|95.0|0.54|1.5|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.50|0.54|0.697
70908922|NCT01152554|141306343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84|STANDARD_ERROR_OF_MEAN|0.27||0.582|TWO_SIDED|95.0|0.45|1.57|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.57|0.45|0.582
70908923|NCT01439711|141306352|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70908924|NCT01439711|141306353|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70908925|NCT01012973|141306364|SUPERIORITY_OR_OTHER||CMH adjusted difference|38.3|||<|0.0001|TWO_SIDED|95.0|24.4|52.1|||Cochran-Mantel-Haenszel||The estimate is calculated as Eylea minus Sham. A positive value shows Eylea showed a higher BCVA total score compared to Sham.|Null hypothesis of difference of Eylea minus Sham of 0 was tested. In the database close after Week 24, basis for primary efficacy evaluation, 56 Sham / 96 Eylea subjects were considered as week 24 completers.||52.1|24.4|<.0001
70908926|NCT01012973|141306365|SUPERIORITY_OR_OTHER||Difference in Least square means|14.7|||<|0.0001|TWO_SIDED|95.0|10.8|18.7||As primary efficacy evaluation was significant, and this p-value was below significance level of two-sided \<.05, the fixed sequence testing did continue with next secondary endpoint.|ANOVA|ANOVA, adjusting for region and baseline BCVA category as fixed factors.|The difference is calculated as Eylea minus Sham. A positive value indicates Eylea showed a higher change in BCVA total score until week 24 compared to Sham.|Null hypothesis was equality in change from baseline to Week 24 in BCVA total letter score between Eylea and Sham. If primary efficacy was successful, secondary efficacy endpoints were tested in a pre-specified fixed sequence testing procedure. Change in BCVA letter score was to be tested first in this sequence.||18.7|10.8|<.0001
70908927|NCT01012973|141306366|SUPERIORITY_OR_OTHER||Difference in Least square (LS) means|-239.42|||<|0.0001|TWO_SIDED|95.0|-286.31|-192.53||As fixed sequence testing did reject nullhypothesis of change from baseline in BCVA until week 24, and this p-value was below significance level of two-sided \<.05, the fixed sequence testing did continue with next secondary endpoint.|ANCOVA|ANCOVA, stratified by region and baseline BCVA category, baseline central retinal thickness added as covariate.|The difference is calculated as Eylea minus Sham. A negative value indicates Eylea showed a higher reduction in change in central retinal thickness until week 24 compared to Sham.|Null hypothesis was equality in change from baseline to Week 24 in central retinal thickness between Eylea and Sham. If primary efficacy was successful, secondary efficacy end points were to be tested in a pre-specified fixed sequence testing procedure. Change in central retinal thickness was to be tested at second place in this sequence.||-192.53|-286.31|<.0001
70908928|NCT01012973|141306367|SUPERIORITY_OR_OTHER||CMH adjusted Difference|-1.5||||0.5947|TWO_SIDED|95.0|-7.4|4.4||As fixed sequence testing did reject nullhypothesis of change from baseline in CRT until week 24, and this p-value was not below significance level of two-sided \<.05, the fixed sequence testing did end with this evaluation.|Cochran-Mantel-Haenszel|Cochrane-Mantel-Haenszel test, stratified by region and baseline BCVA category.||Nullhypothesis of no difference in development of neovascularizations between Eylea and Sham group was tested. (Any neovascularization)||4.4|-7.4|0.5947
70908929|NCT01012973|141306368|SUPERIORITY_OR_OTHER||Difference in LS means|4.2|||||TWO_SIDED|95.0|1.7|6.8|||||As the fixed sequence of secondary endpoints stopped with proportion of neovascularizations developed until week 24, 95% confidence interval is only of descriptive nature.|||6.8|1.7|
70908930|NCT01012973|141306369|SUPERIORITY_OR_OTHER||Difference in LS Means|0.044|||||TWO_SIDED|95.0|-0.002|0.09|||||As the fixed sequence of secondary endpoints stopped with proportion of neovascularizations developed until week 24, 95% confidence interval is only of descriptive nature.|||0.09|-0.002|
70908931|NCT02806336|141306391|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||change in combined groups||||0.03
70908932|NCT02806336|141306392|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|||||||0.34
70908933|NCT02806336|141306393|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||||||0.78
70908934|NCT02806336|141306394|SUPERIORITY|||||||0.03||||||change in functional gait analysis (FGA) in combined groups compared to baseline|t-test, 2 sided|||||||0.03
70908935|NCT02806336|141306395|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
70908936|NCT02806336|141306396|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||.17
70908937|NCT02806336|141306396|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
70908938|NCT02806336|141306397|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||||||0.23
70908939|NCT03990363|141306416|SUPERIORITY|||||||0.0648|||||||Repeated Measures Mixed Model|||||||0.0648
70908940|NCT03990363|141306416|SUPERIORITY|||||||0.6296|||||||Repeated Measures Mixed Model|||||||0.6296
70908941|NCT03990363|141306416|SUPERIORITY|||||||0.0263|||||||Repeated Measures Mixed Model|||||||0.0263
71008708|NCT02055976|141525244|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.571|STANDARD_ERROR_OF_MEAN|3.384||0.003|TWO_SIDED|95.0|2.847|16.295|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||16.295|2.847|0.003
71008709|NCT02055976|141525244|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.029|STANDARD_ERROR_OF_MEAN|2.858||0.001|TWO_SIDED|95.0|3.348|14.71|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||14.710|3.348|0.001
70908942|NCT00556374|141306431|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.504|||<|0.0001|TWO_SIDED|95.0|0.39|0.65|||Cox Proportional Hazards Model|Stratification factors are hospital type, prior use of aromatase inhibitor, and baseline lumbar spine BMD.|From the Cox proportional hazard model with treatment as the independent variable and stratified by randomization strata. A hazard ratio \< 1.0 indicates a lower average event rate and a longer fracture-free time for denosumab relative to placebo.|The efficacy clinical hypothesis is that denosumab, when administered subcutaneously at a dose of 60 mg every 6 months, will be considered efficacious in patients with non-metastatic breast cancer receiving AIT if the rate of first clinical fracture in denosumab-treated patients is lower than that in placebo-treated patients. It is anticipated that denosumab will reduce the rate by 30% compared with placebo (ie, the true hazard ratio of denosumab compared with placebo is 0.70).||0.65|0.39|<0.0001
70908943|NCT00556374|141306432|SUPERIORITY_OR_OTHER_LEGACY||Difference from Placebo|10.02|||<|0.0001|TWO_SIDED|95.0|9.04|11.01||The Hochberg procedure was used to control for multiplicity.|ANCOVA|Model includes treatment group as the independent variable and adjusted for baseline value and the randomization stratification factors.||||11.01|9.04|<0.0001
70908944|NCT00556374|141306433|SUPERIORITY_OR_OTHER_LEGACY||Difference from Placebo|7.92|||<|0.0001|TWO_SIDED|95.0|6.87|8.97||The Hochberg procedure was used to control for multiplicity.|ANCOVA|Model includes treatment group as the independent variable and adjusted for baseline value and the randomization stratification factors.||||8.97|6.87|<0.0001
70908945|NCT00556374|141306434|SUPERIORITY_OR_OTHER_LEGACY||Difference from Placebo|6.51|||<|0.0001|TWO_SIDED|95.0|5.62|7.39||The Hochberg procedure was used to control for multiplicity.|ANCOVA|Model includes treatment group as the independent variable and adjusted for baseline value and the randomization stratification factors.||||7.39|5.62|<0.0001
70908946|NCT00556374|141306435|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.53||||0.0088|TWO_SIDED|95.0|0.33|0.85|||Regression, Logistic|Logistic regression model includes treatment groups as the independent variable and stratified by the randomization stratification factors.|Values \< 1 for odds ratio favor denosumab.|||0.85|0.33|0.0088
70908947|NCT00556374|141306436|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.54||||0.007|TWO_SIDED|95.0|0.34|0.84|||Regression, Logistic|Logistic regression model includes treatment groups as the independent variable and stratified by the randomization stratification factors.|Values \< 1 for odds ratio favor denosumab.|||0.84|0.34|0.0070
70908948|NCT00556374|141306437|SUPERIORITY||Hazard Ratio (HR)|0.816||||0.0515|TWO_SIDED|95.0|0.66|1.0|||Cox Proportional Hazards Model|Stratified by randomization strata (hospital type, use of aromatase inhibitor, baseline lumbar spine BMD).|From the Cox Proportional hazards model with treatment fitted as a covariate and stratified by randomization strata. A hazard ratio \< 1.0 indicates a lower average event rate and a longer disease-free time for denosumab relative to placebo.|||1.00|0.66|0.0515
70908949|NCT00556374|141306438|SUPERIORITY|Analysis of BMFS was conditional on the outcome of DFS due to hierarchical testing strategy, therefore p-value not reported.|Hazard Ratio (HR)|0.808|||||TWO_SIDED|95.0|0.654|0.997|||||A hazard ratio \< 1.0 indicates a lower average event rate and a longer bone metastases-free time for denosumab relative to placebo.|||0.997|0.654|
70908950|NCT00556374|141306439|SUPERIORITY|Analysis of OS was conditional on the outcome of DFS due to hierarchical testing strategy, therefore p-value not reported.|Hazard Ratio (HR)|0.802|||||TWO_SIDED|95.0|0.635|1.013|||||A hazard ratio \< 1.0 indicates a lower average event rate and a longer overall survival time for denosumab relative to placebo.|||1.013|0.635|
70908951|NCT00462644|141306483|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|||||||0.007
70908952|NCT00462644|141306484|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||t-test, 2 sided|||||||0.011
70908953|NCT00462644|141306485|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|||||||0.007
70908954|NCT00462644|141306486|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||t-test, 2 sided|||Normality was tested using the Kolmogorow-Smirnov test.||||0.022
70908955|NCT00462644|141306487|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
70908956|NCT00462644|141306488|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
70908957|NCT00904150|141306521|SUPERIORITY_OR_OTHER|||||||0.513|||||||Chi-squared|||Statistical analysis is of the distribution of PR PROGINS polymorphism frequencies between groups||||0.513
70908958|NCT00904150|141306522|SUPERIORITY_OR_OTHER|||||||0.75|||||||Chi-squared|||Statistical analysis is of the distribution of Estrogen receptor 1 G594a polymorphism frequencies between groups||||0.75
70908959|NCT00904150|141306523|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.434||||0.002743||95.0|0.24|0.75|||Chi-squared|||Analysis of distribution of TNF genotype frequencies between groups||0.75|0.24|0.002743
70908960|NCT00904150|141306524|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.02462||95.0|0.49|0.95|||Chi-squared|||Analysis of distribution of SYNE1 genotype frequencies between groups||0.95|0.49|0.02462
70908961|NCT00904150|141306525|SUPERIORITY_OR_OTHER|||||||0.18|||||||Chi-squared|||Statistical analysis is of the distribution of Estrogen receptor 1 C325G polymorphism frequencies between groups||||0.18
70908962|NCT00904150|141306526|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||||||>0.05
70908963|NCT00904150|141306527|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||||||>0.05
70908964|NCT04212169|141306570|SUPERIORITY||Mean Difference (Final Values)|1.27|STANDARD_ERROR_OF_MEAN|8.981||0.888|TWO_SIDED|90.0|-13.67|16.22|||Mixed Models Analysis||Differences less than 0 favours MEDI3506|||16.22|-13.67|0.888
70908965|NCT04212169|141306570|SUPERIORITY||Mean Difference (Final Values)|5.87|STANDARD_ERROR_OF_MEAN|9.756||0.549|TWO_SIDED|90.0|-10.36|22.1|||Mixed Models Analysis||Differences less than 0 favours MEDI3506|||22.10|-10.36|0.549
70908966|NCT04212169|141306570|SUPERIORITY||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|7.014||0.807|TWO_SIDED|90.0|-13.38|9.95|||Mixed Models Analysis||Differences less than 0 favours MEDI3506|||9.95|-13.38|0.807
70908967|NCT04212169|141306572|SUPERIORITY||Odds Ratio (OR)|1.53||||0.6396|TWO_SIDED|90.0|0.19|9.94|||Fisher Exact||Odds ratio greater than 1 favours MEDI3506|||9.94|0.19|0.6396
70908968|NCT04212169|141306572|SUPERIORITY||Odds Ratio (OR)|0.76||||0.9999|TWO_SIDED|90.0|0.03|6.38|||Fisher Exact||Odds ratio greater than 1 favours MEDI3506|||6.38|0.03|0.9999
70908969|NCT04212169|141306572|SUPERIORITY||Odds Ratio (OR)|2.89||||0.0935|TWO_SIDED|90.0|0.91|10.49|||Regression, Logistic||Odds ratio greater than 1 favours MEDI3506|||10.49|0.91|0.0935
70908970|NCT04212169|141306574|SUPERIORITY||Odds Ratio (OR)|3.06||||0.445|TWO_SIDED|90.0|0.08|119.65|||Fisher Exact||Odds ratio greater than one favour MEDI3506|||119.65|0.08|0.4450
70908971|NCT04212169|141306574|SUPERIORITY||Odds Ratio (OR)|0.0||||0.9999|TWO_SIDED|90.0|0.0|28.0|||Fisher Exact||Odds ratio greater than 1 favours MEDI3506|||28.0|0.0|0.9999
70908972|NCT04212169|141306574|SUPERIORITY||Odds Ratio (OR)|5.5||||0.1132|TWO_SIDED|90.0|0.75|130.35|||Fisher Exact||Odds ratio greater than 1 favours MEDI3506|||130.35|0.75|0.1132
70908973|NCT02718417|141306601|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.989|TWO_SIDED|95.0|1.051|1.946||One-sided log-rank test was used.|Log Rank|Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.||||1.946|1.051|0.9890
70908974|NCT02718417|141306601|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.7935|TWO_SIDED|95.0|0.832|1.565||One-sided log-rank test was used.|Log Rank|Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.||||1.565|0.832|0.7935
70908975|NCT02718417|141306602|SUPERIORITY||Hazard Ratio (HR)|1.53||||0.8848|TWO_SIDED|95.0|0.76|3.08||One-sided log-rank test was used.|Log Rank|Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.||||3.080|0.760|0.8848
70908976|NCT02718417|141306602|SUPERIORITY||Hazard Ratio (HR)|1.55||||0.8953|TWO_SIDED|95.0|0.776|3.111||One-sided log-rank test was used.|Log Rank|Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.||||3.111|0.776|0.8953
71153636|NCT03563183|141799776|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the confimed herpes zoster for Herpes Zoster subunit vaccine group compared to placebo people.|Vaccine Efficacy rate|90.4|||<|0.0001|TWO_SIDED|95.0|84.41|94.43|||Poisson exact test|||Efficacy analysis aimed at comparing the confimed herpes zoster for Herpes Zoster incidence rate between Pre-Frail-HZ/su vs Pre-Frail-Placebo groups.||94.43|84.41|<0.0001
70908977|NCT02718417|141306603|OTHER||Hazard Ratio (HR)|1.21||||0.9278|TWO_SIDED|95.0|0.935|1.578||One-sided log-rank test was used.|Log Rank|||||1.578|0.935|0.9278
70908978|NCT02718417|141306603|OTHER||Hazard Ratio (HR)|0.9||||0.2367|TWO_SIDED|95.0|0.688|1.189||One-sided log-rank test was used.|Log Rank|||||1.189|0.688|0.2367
70908979|NCT02451930|141306638|OTHER|||||||0.4491|||||||Fisher Exact|||||||0.4491
70908980|NCT01676220|141306685|NON_INFERIORITY_OR_EQUIVALENCE|"Stepwise closed testing approach was used to assess non-inferiority and superiority sequentially:~1. Non-inferiority of HOE901-U300 vs Lantus: Upper bound of two-sided 95% confidence interval (CI) of difference between HOE901-U300 and Lantus on mITT population is \<0.4%.~2. Superiority (only if non-inferiority has been demonstrated): Upper bound of two-sided 95% CI for difference in mean change in HbA1c from baseline to endpoint between HOE901-U300 and Lantus on mITT population is \<0."|Least Squares (LS) Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.067|||TWO_SIDED|95.0|-0.09|0.174||||||Analysis was performed using mixed model for repeated measurements (MMRM) with treatment groups, strata of screening HbA1c (\<8.0, \>=8.0%), geographical region (Non-Japan; Japan), visit and visit-by-treatment groups interaction as fixed categorical effects; baseline HbA1c and baseline HbA1c-by-visit interaction as continuous fixed covariates.||0.174|-0.090|
70908981|NCT01676220|141306686|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.89||||0.4536|TWO_SIDED|95.0|0.66|1.2|||Cochran-Mantel-Haenszel|||A one-sided test (at alpha=0.025) for superiority of HOE901-U300 over Lantus was to be performed in case the non-inferiority of HOE901-U300 vs Lantus for the primary endpoint was demonstrated. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method stratified by randomization strata of screening HbA1c (\<8.0, \>=8.0%), randomization strata of geographical region (Non-Japan; Japan).||1.20|0.66|0.4536
70908982|NCT01676220|141306687|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.224|||TWO_SIDED|95.0|-0.275|0.605||||||Change in pre-injection SMPG was analyzed using MMRM model with treatment groups, strata of screening HbA1c (\<8.0, \>=8.0%), geographical region (Non-Japan; Japan), visit and visit-by-treatment groups interaction as fixed categorical effects; baseline preinjection SMPG value and baseline preinjection SMPG value-by-visit interaction as continuous fixed covariates.||0.605|-0.275|
70908983|NCT04496167|141306698|OTHER||Least Square Mean Treatment Difference|1.386||||0.659|TWO_SIDED|95.0|-4.804|7.577||Considered significant if p-value is less than 0.05.|MMRM||"The model included treatment, visit and interaction of treatment, visit as fixed effects, Baseline as a covariate, and repeated measures with visit/participant.~Treatment difference: EN3835 - Placebo"|Mixed Model Repeated Measures (MMRM) was performed to estimate the change from Baseline treatment effect of the adapted ASES composite score in the affected shoulder comparing EN3835 to placebo treatment.||7.577|-4.804|0.659
70908984|NCT03088137|141306759|EQUIVALENCE|Study power of at least 80% at a significance level (alpha error) 5% and a pre-determined clinical equivalence margin of +/- 3.4 oocytes for the relevant population.|Mean Difference (Final Values)|0.546|STANDARD_DEVIATION|1.297||0.002|TWO_SIDED|95.0|-2.026|3.116|||Wilcoxon (Mann-Whitney)|||||3.116|-2.026|0.002
70908985|NCT03088137|141306760|SUPERIORITY||Mean Difference (Final Values)|0.709|STANDARD_DEVIATION|1.067||0.806|TWO_SIDED|95.0|-1.405|2.824|||Wilcoxon (Mann-Whitney)|||||2.824|-1.405|0.806
70908986|NCT03088137|141306761|SUPERIORITY||Mean Difference (Final Values)|0.218|STANDARD_DEVIATION|1.129||0.617|TWO_SIDED|95.0|-2.455|2.019|||Wilcoxon (Mann-Whitney)|||||2.019|-2.455|0.617
70908987|NCT03088137|141306762|SUPERIORITY||Mean Difference (Final Values)|0.636|STANDARD_DEVIATION|1.19||0.445|TWO_SIDED|95.0|-2.995|1.723|||Wilcoxon (Mann-Whitney)|||||1.723|-2.995|0.445
70908988|NCT03088137|141306763|SUPERIORITY|||||||0.623|||||||ANOVA|||||||0.623
70908989|NCT03088137|141306764|SUPERIORITY||Mean Difference (Final Values)|14.9|STANDARD_DEVIATION|49.8||0.488|TWO_SIDED|95.0|-83.9|113.6|||Wilcoxon (Mann-Whitney)|||||113.6|-83.9|0.488
70908990|NCT03088137|141306765|SUPERIORITY||Mean Difference (Final Values)|0.018|STANDARD_DEVIATION|0.201||0.629|TWO_SIDED|95.0|-0.379|0.416|||Wilcoxon (Mann-Whitney)|||||0.416|-0.379|0.629
70908991|NCT03088137|141306766|SUPERIORITY|||||||0.644|||||||Wilcoxon (Mann-Whitney)|||||||0.644
70908992|NCT03088137|141306769|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.833|TWO_SIDED|95.0|-21.0|17.0|||Chi-squared|||95% confidence intervals (CIs) of point estimates were calculated using the exact binomial distribution (Clopper-Pearson method) for proportions.||17.0|-21.0|0.833
70908993|NCT03088137|141306770|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.507|TWO_SIDED|95.0|-24.3|11.9|||Chi-squared|||95% confidence intervals (CIs) of point estimates were calculated using the exact binomial distribution (Clopper-Pearson method) for proportions.||11.9|-24.3|0.507
70908994|NCT00136916|141306787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.011||||90.0|-0.064|-0.026|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|M3||-0.026|-0.064|
70908995|NCT00136916|141306787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.025|0.02|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M6||0.020|-0.025|
70908996|NCT00136916|141306787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.033|0.013|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|M9||0.013|-0.033|
70908997|NCT00136916|141306787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.044|0.004|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M12||0.004|-0.044|
70908998|NCT00136916|141306787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.015||||90.0|-0.048|0.003|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|M15||0.003|-0.048|
70908999|NCT00136916|141306787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.016||||90.0|-0.05|0.004|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|M18||0.004|-0.050|
70909000|NCT00136916|141306787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.017||||90.0|-0.047|0.007|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|M21||0.007|-0.047|
70909001|NCT00136916|141306787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.026|STANDARD_ERROR_OF_MEAN|0.017||||90.0|-0.054|0.002|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M24||0.002|-0.054|
71030641|NCT01029353|141569498|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.16, 95% credible interval of (0.50, 2.65).|||
70909002|NCT00136916|141306787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.017||||90.0|-0.021|0.034|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M1||0.034|-0.021|
70909003|NCT00136916|141306787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.018||||90.0|-0.016|0.044|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M3||0.044|-0.016|
70909004|NCT00136916|141306787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.027|STANDARD_ERROR_OF_MEAN|0.017||||90.0|-0.002|0.055|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M6||0.055|-0.002|
70909005|NCT00136916|141306787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.022||||90.0|-0.04|0.032|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M1||0.032|-0.040|
70909006|NCT00136916|141306787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.033|STANDARD_ERROR_OF_MEAN|0.023||||90.0|-0.07|0.004|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M3||0.004|-0.070|
70909007|NCT00136916|141306787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|0.023||||90.0|-0.077|-0.002|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M6||-0.002|-0.077|
70909008|NCT00136916|141306787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.036|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.075|0.003|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|Ext M9||0.003|-0.075|
70909009|NCT00136916|141306787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.018|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.058|0.022|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M12||0.022|-0.058|
70909010|NCT00136916|141306787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.034|0.048|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|Ext M15||0.048|-0.034|
70909011|NCT00136916|141306787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.011|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.055|0.033|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M18||0.033|-0.055|
70909012|NCT00136916|141306787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.026||||90.0|-0.058|0.029|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|Ext M21||0.029|-0.058|
70909013|NCT00136916|141306787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.061|0.03|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M24||0.030|-0.061|
70909014|NCT00136916|141306787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.026||||90.0|-0.044|0.043|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|Ext M27||0.043|-0.044|
70909015|NCT00136916|141306787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.051|0.04|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M30||0.040|-0.051|
70909016|NCT00136916|141306787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.03||||90.0|-0.042|0.058|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|Ext M33||0.058|-0.042|
70909017|NCT00136916|141306787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.032||||90.0|-0.03|0.077|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M36||0.077|-0.030|
70909018|NCT00136916|141306787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.023||||90.0|-0.042|0.035|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height. Ext M36 (LOCF) based on data in the extension phase only.|Ext M36 LOCF||0.035|-0.042|
70909019|NCT00136916|141306787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.019|STANDARD_ERROR_OF_MEAN|0.026||||90.0|-0.023|0.062|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext FU M3||0.062|-0.023|
70909020|NCT00136916|141306793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.119|STANDARD_ERROR_OF_MEAN|0.058||||90.0|-0.215|-0.023|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M3||-0.023|-0.215|
70909021|NCT00136916|141306793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.067||||90.0|-0.133|0.087|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M6||0.087|-0.133|
70909022|NCT00136916|141306793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.069||||90.0|-0.104|0.124|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M9||0.124|-0.104|
70909023|NCT00136916|141306793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.075||||90.0|-0.033|0.214|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M12||0.214|-0.033|
70970009|NCT02873936|141445719|SUPERIORITY||Least Squares Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|1.71|<|0.001|TWO_SIDED|95.0|-9.4|-2.7||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.7|-9.4|<0.001
71030642|NCT01029353|141569499|SUPERIORITY||Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.34|2.2|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||2.20|0.34|
70909024|NCT00136916|141306793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|STANDARD_ERROR_OF_MEAN|0.081||||90.0|-0.081|0.185|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M15||0.185|-0.081|
70909025|NCT00136916|141306793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.087||||90.0|-0.054|0.234|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M18||0.234|-0.054|
70909026|NCT00136916|141306793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.085||||90.0|-0.073|0.208|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M21||0.208|-0.073|
70909027|NCT00136916|141306793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.096||||90.0|-0.058|0.257|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M24||0.257|-0.058|
70909028|NCT00136916|141306793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.09||||90.0|-0.143|0.154|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|FU M3||0.154|-0.143|
70909029|NCT00136916|141306793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036|STANDARD_ERROR_OF_MEAN|0.094||||90.0|-0.119|0.19|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|FU M6||0.190|-0.119|
70909030|NCT00136916|141306793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.11||||90.0|-0.2|0.161|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M1||0.161|-0.200|
70909031|NCT00136916|141306793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.11||||90.0|-0.101|0.263|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M3||0.263|-0.101|
70909032|NCT00136916|141306793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.108||||90.0|-0.038|0.32|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M6||0.320|-0.038|
71030643|NCT01029353|141569499|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.93, 95% credible interval of (0.45, 1.91).|||
70909033|NCT00136916|141306793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.116||||90.0|-0.041|0.342|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M9||0.342|-0.041|
70909034|NCT00136916|141306793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.118||||90.0|-0.09|0.298|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M12||0.298|-0.090|
70909035|NCT00136916|141306793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.074|STANDARD_ERROR_OF_MEAN|0.125||||90.0|-0.132|0.279|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M15||0.279|-0.132|
70909036|NCT00136916|141306793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.12||||90.0|-0.111|0.284|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M18||0.284|-0.111|
70909037|NCT00136916|141306793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064|STANDARD_ERROR_OF_MEAN|0.124||||90.0|-0.141|0.27|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M21||0.270|-0.141|
70909038|NCT00136916|141306793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.123||||90.0|-0.156|0.249|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M24||0.249|-0.156|
70909039|NCT00136916|141306793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.067|STANDARD_ERROR_OF_MEAN|0.124||||90.0|-0.138|0.272|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M27||0.272|-0.138|
70909040|NCT00136916|141306793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.132||||90.0|-0.171|0.264|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M30||0.264|-0.171|
70909041|NCT00136916|141306793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.824|STANDARD_ERROR_OF_MEAN|8.319||||90.0|-3.92|23.569|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M33||23.569|-3.920|
70909042|NCT00136916|141306793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.197||||90.0|-0.316|0.337|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M36||0.337|-0.316|
70909043|NCT00136916|141306793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.163||||90.0|-0.245|0.292|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext FU M3||0.292|-0.245|
70909044|NCT00136916|141306794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.39|STANDARD_ERROR_OF_MEAN|4.054||||90.0|-19.07|-5.71|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|M3||-5.710|-19.07|
70909045|NCT00136916|141306794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.21|STANDARD_ERROR_OF_MEAN|4.795||||90.0|-22.11|-6.312|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|M6||-6.312|-22.11|
70909046|NCT00136916|141306794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.96|STANDARD_ERROR_OF_MEAN|4.92||||90.0|-19.07|-2.852|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|M12||-2.852|-19.07|
70909047|NCT00136916|141306794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.56|STANDARD_ERROR_OF_MEAN|5.052||||90.0|-20.89|-4.232|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|M24||-4.232|-20.89|
70909048|NCT00136916|141306794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.83|STANDARD_ERROR_OF_MEAN|21.867||||90.0|-80.69|47.019|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|FU M3||47.019|-80.69|
70909049|NCT00136916|141306794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.578|STANDARD_ERROR_OF_MEAN|7.173||||90.0|-9.257|14.412|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|FU M6||14.412|-9.257|
70909050|NCT00136916|141306794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.46|STANDARD_ERROR_OF_MEAN|6.007||||90.0|-19.37|0.45|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M1||0.450|-19.37|
70909051|NCT00136916|141306794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.481|STANDARD_ERROR_OF_MEAN|6.446||||90.0|-20.11|1.153|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M3||1.153|-20.11|
71030644|NCT01029353|141569500|SUPERIORITY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.37|1.42|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.42|0.37|
70909052|NCT00136916|141306794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.76|STANDARD_ERROR_OF_MEAN|6.785||||90.0|-21.95|0.438|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M6||0.438|-21.95|
70909053|NCT00136916|141306794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.827|STANDARD_ERROR_OF_MEAN|6.154||||90.0|-16.98|3.328|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M9||3.328|-16.98|
70909054|NCT00136916|141306794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.287|STANDARD_ERROR_OF_MEAN|7.192||||90.0|-19.15|4.579|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M12||4.579|-19.15|
70909055|NCT00136916|141306794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.848|STANDARD_ERROR_OF_MEAN|7.219||||90.0|-13.76|10.066|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M15||10.066|-13.76|
70909056|NCT00136916|141306794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.022|STANDARD_ERROR_OF_MEAN|7.156||||90.0|-20.83|2.79|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M18||2.790|-20.83|
70909057|NCT00136916|141306794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.078|STANDARD_ERROR_OF_MEAN|7.217||||90.0|-18.99|4.834|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M21||4.834|-18.99|
70909058|NCT00136916|141306794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.53|STANDARD_ERROR_OF_MEAN|7.329||||90.0|-24.63|-0.429|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M24||-0.429|-24.63|
70909059|NCT00136916|141306794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.07|STANDARD_ERROR_OF_MEAN|6.895||||90.0|-30.45|-7.685|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M27||-7.685|-30.45|
70909060|NCT00136916|141306794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.22|STANDARD_ERROR_OF_MEAN|7.223||||90.0|-15.15|8.705|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M30||8.705|-15.15|
70909061|NCT00136916|141306794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.49|STANDARD_ERROR_OF_MEAN|7.625||||90.0|-21.09|4.107|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M33||4.107|-21.09|
70909062|NCT00136916|141306794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.88|STANDARD_ERROR_OF_MEAN|8.906||||90.0|-36.66|-7.105|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M36||-7.105|-36.66|
70909063|NCT00136916|141306794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.673|STANDARD_ERROR_OF_MEAN|8.77||||90.0|-19.16|9.812|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext FU M3||9.812|-19.16|
70909064|NCT00136916|141306795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.059|STANDARD_ERROR_OF_MEAN|0.217||||90.0|-0.416|0.299|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|M3||0.299|-0.416|
70909065|NCT00136916|141306795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.735|STANDARD_ERROR_OF_MEAN|0.297||||90.0|-1.224|-0.246|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|M6||-0.246|-1.224|
70909066|NCT00136916|141306795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.642|STANDARD_ERROR_OF_MEAN|0.37||||90.0|-1.251|-0.032|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|M12||-0.032|-1.251|
70909067|NCT00136916|141306795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.355|STANDARD_ERROR_OF_MEAN|0.464||||90.0|-2.12|-0.589|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|M24||-0.589|-2.120|
70909068|NCT00136916|141306795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.303|STANDARD_ERROR_OF_MEAN|0.475||||90.0|-2.086|-0.52|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|FU M3||-0.520|-2.086|
70909069|NCT00136916|141306795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.557|STANDARD_ERROR_OF_MEAN|0.596||||90.0|-2.539|-0.575|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|FU M6||-0.575|-2.539|
70909070|NCT00136916|141306795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.904|STANDARD_ERROR_OF_MEAN|0.603||||90.0|-1.898|0.09|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M1||0.090|-1.898|
70909071|NCT00136916|141306795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28|STANDARD_ERROR_OF_MEAN|0.573||||90.0|-2.225|-0.334|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M3||-0.334|-2.225|
70909072|NCT00136916|141306795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.834|STANDARD_ERROR_OF_MEAN|0.652||||90.0|-1.909|0.241|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M6||0.241|-1.909|
70909073|NCT00136916|141306795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.001|STANDARD_ERROR_OF_MEAN|0.654||||90.0|-2.08|0.078|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M9||0.078|-2.080|
70909074|NCT00136916|141306795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.316|STANDARD_ERROR_OF_MEAN|0.676||||90.0|-2.431|-0.2|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M12||-0.200|-2.431|
70909075|NCT00136916|141306795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.512|STANDARD_ERROR_OF_MEAN|0.696||||90.0|-2.661|-0.363|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M15||-0.363|-2.661|
70909076|NCT00136916|141306795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.313|STANDARD_ERROR_OF_MEAN|0.916||||90.0|-2.824|0.198|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M18||0.198|-2.824|
70909077|NCT00136916|141306795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.399|STANDARD_ERROR_OF_MEAN|0.904||||90.0|-3.891|-0.907|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M21||-0.907|-3.891|
70909078|NCT00136916|141306795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.566|STANDARD_ERROR_OF_MEAN|0.788||||90.0|-2.867|-0.265|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M24||-0.265|-2.867|
70909079|NCT00136916|141306795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.72|STANDARD_ERROR_OF_MEAN|1.041||||90.0|-4.439|-1.001|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M27||-1.001|-4.439|
70909080|NCT00136916|141306795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.401|STANDARD_ERROR_OF_MEAN|0.82||||90.0|-2.755|-0.047|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M30||-0.047|-2.755|
70909081|NCT00136916|141306795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.281|STANDARD_ERROR_OF_MEAN|0.908||||90.0|-3.781|-0.782|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M33||-0.782|-3.781|
70909082|NCT00136916|141306795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.766|STANDARD_ERROR_OF_MEAN|1.305||||90.0|-4.932|-0.599|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M36||-0.599|-4.932|
70909083|NCT00136916|141306795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.637|STANDARD_ERROR_OF_MEAN|0.898||||90.0|-3.12|-0.153|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext FU M3||-0.153|-3.120|
70909084|NCT00136916|141306801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.251|STANDARD_ERROR_OF_MEAN|0.13||||90.0|-0.466|-0.037|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M3||-0.037|-0.466|
70909085|NCT00136916|141306801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.095|STANDARD_ERROR_OF_MEAN|0.139||||90.0|-0.323|0.134|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M6||0.134|-0.323|
70909086|NCT00136916|141306801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.146||||90.0|-0.158|0.325|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M9||0.325|-0.158|
70909087|NCT00136916|141306801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.266|STANDARD_ERROR_OF_MEAN|0.156||||90.0|-0.524|-0.009|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M12||-0.009|-0.524|
70909088|NCT00136916|141306801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.181|STANDARD_ERROR_OF_MEAN|0.165||||90.0|-0.453|0.091|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M15||0.091|-0.453|
70909089|NCT00136916|141306801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.141|STANDARD_ERROR_OF_MEAN|0.173||||90.0|-0.427|0.145|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M18||0.145|-0.427|
70909090|NCT00136916|141306801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.155|STANDARD_ERROR_OF_MEAN|0.176||||90.0|-0.445|0.134|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M21||0.134|-0.445|
70909091|NCT00136916|141306801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.189||||90.0|-0.193|0.431|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M24||0.431|-0.193|
70909092|NCT00136916|141306801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.617|STANDARD_ERROR_OF_MEAN|0.179||||90.0|0.322|0.911|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M1||0.911|0.322|
70909093|NCT00136916|141306801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.354|STANDARD_ERROR_OF_MEAN|0.184||||90.0|0.051|0.657|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M3||0.657|0.051|
70909094|NCT00136916|141306801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.318|STANDARD_ERROR_OF_MEAN|0.186||||90.0|0.011|0.626|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M6||0.626|0.011|
70909095|NCT00136916|141306801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.22||||90.0|-0.227|0.5|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M1||0.500|-0.227|
70909096|NCT00136916|141306801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.235||||90.0|-0.289|0.485|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M3||0.485|-0.289|
70909097|NCT00136916|141306801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.202|STANDARD_ERROR_OF_MEAN|0.226||||90.0|-0.576|0.172|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M6||0.172|-0.576|
70909098|NCT00136916|141306801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.245|STANDARD_ERROR_OF_MEAN|0.257||||90.0|-0.18|0.669|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M9||0.669|-0.180|
70909099|NCT00136916|141306801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.248||||90.0|-0.284|0.535|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M12||0.535|-0.284|
70909100|NCT00136916|141306801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.253||||90.0|-0.395|0.441|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M15||0.441|-0.395|
70909101|NCT00136916|141306801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.146|STANDARD_ERROR_OF_MEAN|0.247||||90.0|-0.262|0.554|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M18||0.554|-0.262|
71153637|NCT03563183|141799776|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the confimed herpes zoster for Herpes Zoster subunit vaccine group compared to placebo people.|Vaccine Efficacy rate|90.17|||<|0.0001|TWO_SIDED|95.0|75.36|96.65|||Poisson exact test|||Efficacy analysis aimed at comparing the confimed herpes zoster for Herpes Zoster incidence rate between Frail-HZ/su vs Frail-Placebo groups.||96.65|75.36|<0.0001
70909102|NCT00136916|141306801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.321|STANDARD_ERROR_OF_MEAN|0.278||||90.0|-0.138|0.78|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M21||0.780|-0.138|
70909103|NCT00136916|141306801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.043|STANDARD_ERROR_OF_MEAN|0.28||||90.0|-0.419|0.506|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M24||0.506|-0.419|
70909104|NCT00136916|141306801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.284||||90.0|-0.279|0.659|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M27||0.659|-0.279|
70909105|NCT00136916|141306801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.117|STANDARD_ERROR_OF_MEAN|0.28||||90.0|-0.579|0.346|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M30||0.346|-0.579|
70909106|NCT00136916|141306801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.262|STANDARD_ERROR_OF_MEAN|0.273||||90.0|-0.189|0.714|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M33||0.714|-0.189|
70909107|NCT00136916|141306801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.267|STANDARD_ERROR_OF_MEAN|0.383||||90.0|-0.37|0.904|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M36||0.904|-0.370|
70909108|NCT00136916|141306801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.399|STANDARD_ERROR_OF_MEAN|0.244||||90.0|-0.003|0.802|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height. Ext M36 (LOCF) based on data in the extension phase only.|Ext M36 LOCF||0.802|-0.003|
70909109|NCT00136916|141306801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.619|STANDARD_ERROR_OF_MEAN|0.292||||90.0|0.137|1.102|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext FU M3||1.102|0.137|
70909110|NCT04179461|141306875|EQUIVALENCE|The Wilcoxon signed-rank test was employed for pairwise comparison between visits for continuous data. Data for the CASI was captured at clinical visits. 3. A level of statistical significance was established at \< 0.05.||||||0.52||||||Change in CASI score from V1 to V3|Wilcoxon (Mann-Whitney)|||The modified CASI score incorporates key asthma outcomes such as symptoms, healthcare utilization, and medication dose.||||0.52
70909111|NCT04179461|141306876|EQUIVALENCE|The Wilcoxon signed-rank test was employed for pairwise comparison between visits for continuous data. Data for the c-ACT/ACT was captured at clinical visits and from monthly phone calls. Because c-ACT/ACT could vary through time, we calculated the average c-ACT/ACT between V1-V2 and V2-V3. Data analysis was performed in SAS version 9.4 (SAS, Cary, NC). A level of statistical significance was established at \< 0.05.||||||0.45||||||The change in ACT score from V1 to V2 (the period between V1 and V2).|Wilcoxon (Mann-Whitney)|||||||0.45
70909112|NCT04179461|141306876|EQUIVALENCE|The Wilcoxon signed-rank test was employed for pairwise comparison between visits for continuous data. Data for the c-ACT/ACT was captured at clinical visits and from monthly phone calls. Because c-ACT/ACT could vary through time, we calculated the average c-ACT/ACT between V1-V2 and V2-V3. Data analysis was performed in SAS version 9.4 (SAS, Cary, NC). A level of statistical significance was established at \< 0.05.||||||0.01||||||The change in ACT score from V1-V2 to V2-V3.|Wilcoxon (Mann-Whitney)|||||||0.01
70909113|NCT04179461|141306877|EQUIVALENCE|The Wilcoxon signed-rank test was employed for pairwise comparison between visits for continuous data and the Bowker's test was used to compare categorical FEV1-FVC data. Data analysis was performed in SAS version 9.4 (SAS, Cary, NC). A level of statistical significance was established at \< 0.05.||||||0.27||||||The Change in FEV1/FVC from Visit 1 to Visit 3|Wilcoxon (Mann-Whitney)|||||||0.27
70909114|NCT04179461|141306878|EQUIVALENCE|Intervention adherence and end of study adherence were each calculated based on the 30 days prior to end of intervention and V3, respectively, in order to assess a consistent timeframe. The paired Wilcoxon signed rank test was conducted to compare controller inhaler adherence during baseline, adherence intervention, and end of study.||||||0.17||||||Change between baseline (V1) to end of study (V3)|Wilcoxon (Mann-Whitney)|||||||0.17
70909115|NCT01607411|141306885|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.59|||<|0.0001|TWO_SIDED|95.0|3.6|7.58||No adjustment was required for multiple comparisons as the primary comparison was pre-specified.|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.||7.58|3.60|<0.0001
70909116|NCT01607411|141306885|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.36|||<|0.0001|TWO_SIDED|95.0|2.37|6.35||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||6.35|2.37|<0.0001
70909117|NCT01607411|141306885|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.16||||0.0021|TWO_SIDED|95.0|1.17|5.15||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||5.15|1.17|0.0021
70909118|NCT01607411|141306886|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.23||||0.2225|TWO_SIDED|95.0|-0.76|3.22||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||3.22|-0.76|0.2225
70909119|NCT01607411|141306886|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.44||||0.0168|TWO_SIDED|95.0|0.44|4.43||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.||4.43|0.44|0.0168
70909120|NCT01607411|141306886|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.2||||0.2352|TWO_SIDED|95.0|-0.79|3.19||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||3.19|-0.79|0.2352
70909121|NCT01607411|141306887|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|34.65|||<|0.0001|TWO_SIDED|95.0|30.07|39.24||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||39.24|30.07|<0.0001
70909122|NCT01607411|141306887|SUPERIORITY_OR_OTHER||Adjusted Mean difference|34.86|||<|0.0001|TWO_SIDED|95.0|30.28|39.44||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||39.44|30.28|<0.0001
70909123|NCT01607411|141306887|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|28.55|||<|0.0001|TWO_SIDED|95.0|23.97|33.13||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||33.13|23.97|< 0.0001
70909124|NCT01607411|141306887|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21||||0.9292|TWO_SIDED|95.0|-4.79|4.38||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||4.38|-4.79|0.9292
70909125|NCT01607411|141306887|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.1||||0.0094|TWO_SIDED|95.0|1.52|10.69||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||10.69|1.52|0.0094
70909126|NCT01607411|141306887|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.31||||0.0073|TWO_SIDED|95.0|1.72|10.89||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||10.89|1.72|0.0073
71030645|NCT01029353|141569500|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.75, 95% credible interval of (0.48, 1.16).|||
70909127|NCT01607411|141306888|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.78|||<|0.0001|TWO_SIDED|95.0|0.58|0.98||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random factor|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||0.98|0.58|<0.0001
70909128|NCT01607411|141306888|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.79|||<|0.0001|TWO_SIDED|95.0|0.58|0.99||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||0.99|0.58|<0.0001
70909129|NCT01607411|141306888|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.49|||<|0.0001|TWO_SIDED|95.0|0.29|0.69||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||0.69|0.29|< 0.0001
70909130|NCT01607411|141306888|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.005||||0.9631|TWO_SIDED|95.0|-0.21|0.2||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||0.20|-0.21|0.9631
70909131|NCT01607411|141306888|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.29||||0.0047|TWO_SIDED|95.0|0.09|0.49||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||0.49|0.09|0.0047
70909132|NCT01607411|141306888|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.3||||0.004|TWO_SIDED|95.0|0.1|0.5||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||0.50|0.10|0.0040
70909133|NCT02107443|141306903|SUPERIORITY||Mean Difference (Final Values)|3.59|||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.0001
71030646|NCT01029353|141569501|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.7|1.15|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.15|0.70|
70909134|NCT02107443|141306904|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.041|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.041
70909135|NCT02107443|141306906|SUPERIORITY||Mean Difference (Final Values)|1.05||||0.03|TWO_SIDED|95.0|0.12|1.98|||Mixed Models Analysis|The above p-values is for 4-6 weeks.|The above values are for 4-6 weeks.|||1.98|0.12|0.03
70909136|NCT02107443|141306906|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.08|TWO_SIDED|95.0|-0.11|1.77|||Mixed Models Analysis|The above p-value is for is for 3 months.|The above values are for 3 months|||1.77|-0.11|.08
70909137|NCT02107443|141306906|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.2|TWO_SIDED|95.0|-0.36|1.59|||Mixed Models Analysis|The above p-value is for 6 months|The above values are for 6 months.|||1.59|-0.36|0.20
70909138|NCT01706965|141306949|SUPERIORITY|||||||0.38|||||||ANOVA|||Univariate ANOVA, controlling for baseline PANSS total||||.38
70909139|NCT01706965|141306950|SUPERIORITY|ANOVA, controlled for baseline MATRICS||||||0.99|||||||ANOVA|||||||.99
70909140|NCT01563978|141306951|SUPERIORITY_OR_OTHER||Least squares mean treatment difference|2.93||||0.023|TWO_SIDED|95.0|0.4|5.45|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||||5.45|0.40|0.023
70909141|NCT01563978|141306952|SUPERIORITY_OR_OTHER||Least squares mean treatment difference|3.53|||<|0.001|TWO_SIDED|95.0|2.04|5.03|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||||5.03|2.04|<0.001
70909142|NCT01563978|141306953|SUPERIORITY_OR_OTHER||Least square means treatment difference|3.3||||0.02|TWO_SIDED|95.0|0.53|6.08|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean daytime SBP (Day 28)||6.08|0.53|0.020
70909143|NCT01563978|141306953|SUPERIORITY_OR_OTHER||Least square means treatment difference|3.75|||<|0.001|TWO_SIDED|95.0|2.08|5.42|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean daytime DBP (Day 28)||5.42|2.08|<0.001
70909144|NCT01563978|141306953|SUPERIORITY_OR_OTHER||Least square means treatment difference|2.07||||0.179|TWO_SIDED|95.0|-0.96|5.11|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean night-time SBP (Day 28)||5.11|-0.96|0.179
70909145|NCT01563978|141306953|SUPERIORITY_OR_OTHER||Least square means treatment difference|3.14||||0.002|TWO_SIDED|95.0|1.13|5.14|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean night-time DBP (Day 28)||5.14|1.13|0.002
71030647|NCT01029353|141569501|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.91, 95% credible interval of (0.65, 1.27).|||
70909146|NCT01563978|141306954|SUPERIORITY_OR_OTHER||Least square means treatment difference|3.11||||0.024|TWO_SIDED|95.0|0.41|5.81|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean awake SBP (Day 28)||5.81|0.41|0.024
70909147|NCT01563978|141306954|SUPERIORITY_OR_OTHER||Least square means treatment difference|3.66|||<|0.001|TWO_SIDED|95.0|2.1|5.22|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean awake DBP (Day 28)||5.22|2.10|<0.001
70909148|NCT01563978|141306955|SUPERIORITY_OR_OTHER||Least squares mean treatment difference|1.99||||0.223|TWO_SIDED|95.0|-1.22|5.2|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean sleeping SBP||5.20|-1.22|0.223
70909149|NCT01563978|141306955|SUPERIORITY_OR_OTHER||Least square means treatment difference|2.87||||0.007|TWO_SIDED|95.0|0.81|4.93|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean sleeping DBP||4.93|0.81|0.007
70909150|NCT01563978|141306956|SUPERIORITY_OR_OTHER||Least square means treatment difference|2.24||||0.2|TWO_SIDED|95.0|-1.2|5.69|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in clinic SBP (Day 29)||5.69|-1.20|0.200
70909151|NCT01563978|141306956|SUPERIORITY_OR_OTHER||Least square means treatment difference|2.36||||0.046|TWO_SIDED|95.0|0.05|4.68|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in clinic DBP (Day 29)||4.68|0.05|0.046
70909152|NCT01563978|141306957|SUPERIORITY_OR_OTHER||Least square means treatment difference|6.31|||<|0.001|TWO_SIDED|95.0|3.6|9.03|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in weekly average pre-dose home SBP (Week 4)||9.03|3.60|<0.001
70909153|NCT01563978|141306957|SUPERIORITY_OR_OTHER||Least square means treatment difference|4.58|||<|0.001|TWO_SIDED|95.0|2.91|6.25|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in weekly average pre-dose home DBP (Week 4)||6.25|2.91|<0.001
70909154|NCT01563978|141306958|SUPERIORITY_OR_OTHER||Least square means treatment difference|7.22|||<|0.001|TWO_SIDED|95.0|4.29|10.16|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in weekly average post-dose home SBP (Week 4)||10.16|4.29|<0.001
70909155|NCT01563978|141306958|SUPERIORITY_OR_OTHER||Least square means treatment difference|4.74|||<|0.001|TWO_SIDED|95.0|2.9|6.59|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in weekly average post-dose home DBP (Week 4)||6.59|2.90|<0.001
70909156|NCT01563978|141306960|SUPERIORITY_OR_OTHER||Least square means treatment difference|0.74|||<|0.001|TWO_SIDED|95.0|0.4|1.08||Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)|ANCOVA|||Improvement from baseline at Day 29. Non-responder imputation has been applied following premature withdrawal, or any dose of background disease modifying antirheumatic drug increased or any other RA treatment initiated including DMARDs, anti-TNFs or other biologics, or receiving any parenteral steroids, or for patients with no post baseline data.||1.08|0.40|<0.001
70909157|NCT00729690|141306961|SUPERIORITY_OR_OTHER|||||||0.4742||95.0|||||ANOVA|||For 1st 24 hours NRS AUC Pain scores||||0.4742
70909158|NCT00729690|141306962|SUPERIORITY_OR_OTHER|||||||0.7596||95.0|||||ANOVA|||||||0.7596
70909159|NCT00729690|141306963|SUPERIORITY_OR_OTHER|||||||0.4321||95.0|||||ANOVA|||||||0.4321
70909160|NCT00729690|141306964|SUPERIORITY_OR_OTHER|||||||0.9361||95.0|||||ANOVA|||||||0.9361
70909161|NCT03077620|141306999|SUPERIORITY||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.064||0.05|TWO_SIDED|95.0|-0.017|0.256||Poor sleepers compared to good sleepers with Compound Symmetry covariance structure. Mean difference is poor sleepers minus good sleepers.|Mixed Models Analysis|||||0.256|-0.017|0.05
70909162|NCT03077620|141307000|SUPERIORITY||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.033||0.05|TWO_SIDED|95.0|-0.078|0.087||After corrected for multiple comparisons with Bonferroni test, treatment groups 1 and 2 compared to placebo with Compound Symmetry covariance structure. Mean difference is placebo minus treatment group.|Mixed Models Analysis|||||0.087|-0.078|0.05
70909163|NCT03077620|141307000|SUPERIORITY||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.033||0.05|TWO_SIDED|95.0|-0.051|0.117||After corrected for multiple comparisons with Bonferroni test, treatment groups 1 and 2 compared to placebo with Compound Symmetry covariance structure. Mean difference is placebo minus treatment group.|Mixed Models Analysis|||||0.117|-0.051|0.05
70909164|NCT01053637|141307016|SUPERIORITY|||||||0.05||||||Pain at 5 minutes using Children's Hospital of Eastern Ontario Pain Scale validated in the younger population. Using a 2-point difference in CHEOPS pain scale as a clinically significant change, 34 patients were required in the younger 2- to 7 group.|Fisher Exact|||Children's Hospital of Eastern Ontario Pain Scale, for children 2-7 years. This score ranks 6 categories: Cry, Facial expression, Verbal Response, Torso movement, Touch, and Leg movement. The scale varies by each category from 0-2 or 1-2 or 1-3; such that a minimum score is 4 (no pain) and a maximum score is 13 signifying greatest or worst pain.||||0.05
71030648|NCT01029353|141569502|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.44|1.36|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.36|0.44|
71030649|NCT01029353|141569502|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.82, 95% credible interval of (0.49, 1.33).|||
71030650|NCT01029353|141569503|SUPERIORITY||Mean Difference (Final Values)|-6.01|||||TWO_SIDED|95.0|-12.77|0.75|||||Mean Difference (MD): Laparotomy minus Drain. MD from mixed model using PROC MIXED in SAS, center as random effect, and reference cell coding. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||0.75|-12.77|
71030651|NCT01029353|141569503|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using a hierarchical linear regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=1000), treatment, baseline risk, and preop diagnosis parameters = Normal(mean=0, variance=10), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median difference Initial Laparotomy minus Initial Drainage was -2.68, 95% credible interval of (-7.11, 1.83).|||
71030652|NCT01029353|141569504|SUPERIORITY||Mean Difference (Final Values)|-8.75|||||TWO_SIDED|95.0|-17.05|-0.46|||||Mean Difference (MD): Laparotomy minus Drain. MD from mixed model using PROC MIXED in SAS, center as random effect, and reference cell coding. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||-0.46|-17.05|
71030653|NCT01029353|141569504|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using a hierarchical linear regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=1000), treatment, baseline risk, and preop diagnosis parameters = Normal(mean=0, variance=10), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median difference Initial Laparotomy minus Initial Drainage was -3.23, 95% credible interval of (-8.08, 1.68).|||
71030654|NCT01029353|141569505|SUPERIORITY||Mean Difference (Final Values)|6.59|||||TWO_SIDED|95.0|-9.09|22.27|||||Mean Difference (MD): Laparotomy minus Drain. MD from mixed model using PROC MIXED in SAS, center as random effect, and reference cell coding. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||22.27|-9.09|
71030655|NCT01029353|141569505|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using a hierarchical linear regression. The SAS procedure PROC MCMC with reference coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=1000), treatment, baseline risk, and preop diagnosis parameters = Normal(mean=0, variance=10), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median difference Initial Laparotomy minus Initial Drainage was 1.65, 95% credible interval of (-3.97, 7.23).|||
71030656|NCT01029353|141569506|SUPERIORITY||Mean Difference (Final Values)|-2.56|||||TWO_SIDED|95.0|-13.02|7.91|||||Mean Difference (MD): Laparotomy minus Drain. MD from mixed model using PROC MIXED in SAS, center as random effect, and reference cell coding. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||7.91|-13.02|
71030657|NCT01029353|141569506|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using a hierarchical linear regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=1000), treatment, baseline risk, and preop diagnosis parameters = Normal(mean=0, variance=10), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median difference Initial Laparotomy minus Initial Drainage was -0.71, 95% credible interval of (-5.89, 4.48).|||
71030658|NCT01029353|141569507|SUPERIORITY||Mean Difference (Final Values)|-13.95|||||TWO_SIDED|95.0|-30.54|2.63|||||Mean Difference (MD): Laparotomy minus Drain. MD from mixed model using PROC MIXED in SAS, center as random effect, and reference cell coding. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||2.63|-30.54|
71030659|NCT01029353|141569507|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using a hierarchical linear regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=1000), treatment, baseline risk, and preop diagnosis parameters = Normal(mean=0, variance=10), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median difference Initial Laparotomy minus Initial Drainage was -1.78, 95% credible interval of (-7.44, 3.87).|||
70970010|NCT02873936|141445721|SUPERIORITY||Least Squares Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|1.1|3.9||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.9|1.1|<0.001
70970011|NCT02873936|141445721|SUPERIORITY||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|0.7||0.005|TWO_SIDED|95.0|0.6|3.4||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.4|0.6|0.005
70970012|NCT02873936|141445721|SUPERIORITY||Least Squares Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|1.02|<|0.001|TWO_SIDED|95.0|1.9|5.9||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.9|1.9|<0.001
70970013|NCT02873936|141445721|SUPERIORITY||Least Squares Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|1.03||0.002|TWO_SIDED|95.0|1.1|5.2||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.2|1.1|0.002
70970014|NCT02873936|141445723|SUPERIORITY||Least Squares Mean Difference|2.3|STANDARD_ERROR_OF_MEAN|0.97||0.019|TWO_SIDED|95.0|0.4|4.2||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.2|0.4|0.019
70970015|NCT02873936|141445723|SUPERIORITY||Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.97||0.073|TWO_SIDED|95.0|-0.2|3.6||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.6|-0.2|0.073
70970016|NCT02873936|141445723|SUPERIORITY||Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|1.03||0.045|TWO_SIDED|95.0|0.0|4.1||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.1|0.0|0.045
70970017|NCT02873936|141445723|SUPERIORITY||Least Squares Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.02||0.32|TWO_SIDED|95.0|-1.0|3.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.0|-1.0|0.32
70970018|NCT02873936|141445723|SUPERIORITY||Least Squares Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|1.19||0.12|TWO_SIDED|95.0|-0.5|4.2||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.2|-0.5|0.12
71153638|NCT03563183|141799776|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the confimed herpes zoster for Herpes Zoster subunit vaccine group compared to placebo people.|Vaccine Efficacy rate|100.0||||0.069|TWO_SIDED|95.0|14.61|100.0|||Poisson exact test|||Efficacy analysis aimed at comparing the confimed herpes zoster for Herpes Zoster incidence rate between Unknown-HZ/su vs Unknown-Placebo groups.||100|14.61|0.069
70970019|NCT02873936|141445723|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.2||0.96|TWO_SIDED|95.0|-2.3|2.4||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.4|-2.3|0.96
70970020|NCT02873936|141445725|SUPERIORITY||Least Squares Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED|95.0|1.6|5.7||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.7|1.6|<0.001
70970021|NCT02873936|141445725|SUPERIORITY||Least Squares Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|1.05||0.002|TWO_SIDED|95.0|1.2|5.4||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.4|1.2|0.002
70909165|NCT01053637|141307017|OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||State-Trait Anxiety Inventory for Children pre vs. post procedure for matched pairs. Higher numbers indicated higher state anxiety. State Trait Anxiety Inventory for Children (STAIC) scores pre vs. post procedure for matched pairs. A lower STAIC score indicates less anxiety and a greater score indicates more anxiety based on Likert-type scales and analyzed using nonparametric testing.||||0.05
70909166|NCT02102464|141307019|SUPERIORITY||Mean Difference (Final Values)|11.0|||<|0.0001|TWO_SIDED|95.0|8.0|14.0|||t-test, 2 sided|||||14.0|8.0|<0.0001
70909167|NCT02102464|141307020|SUPERIORITY||Mean Difference (Final Values)|-7.7|||<|0.0001|TWO_SIDED|95.0|-10.2|-5.2|||t-test, 2 sided|||||-5.2|-10.2|<0.0001
70909168|NCT02102464|141307021|SUPERIORITY||Mean Difference (Final Values)|3.9|||<|0.0001|TWO_SIDED|95.0|2.5|5.4|||t-test, 2 sided|||||5.4|2.5|<0.0001
70909169|NCT01875861|141307054|SUPERIORITY||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|1.02|1.38||||||Because of data discontinuity, assumptions for time series analysis did not hold. Repeated measures regression models were developed to compare overall weight monitoring rates at baseline across the implementation phases.||1.38|1.02|
70909170|NCT01875861|141307055|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|1.03|1.39||||||See comments about time series analysis for primary outcome measure. Repeated measures regression analysis of the likelihood of monitoring for each time period was conducted.||1.39|1.03|
70909171|NCT02325713|141307057|SUPERIORITY_OR_OTHER||Geometric Least square (LS) mean ratio|96.2|||||TWO_SIDED|90.0|83.7|110.6||||||||110.6|83.7|
70909172|NCT02325713|141307057|SUPERIORITY_OR_OTHER||Geometric LS mean ration|18.4|||||TWO_SIDED|90.0|15.3|22.0||||||||22.0|15.3|
70909173|NCT02325713|141307057|SUPERIORITY_OR_OTHER||Geometric LS mean ration|222.7|||||TWO_SIDED|90.0|186.8|265.6||||||||265.6|186.8|
71030660|NCT01029353|141569508|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.64|1.04|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.04|0.64|
70909174|NCT02325713|141307057|SUPERIORITY_OR_OTHER||Geometric LS mean ration|238.1|||||TWO_SIDED|90.0|198.7|285.3||||||||285.3|198.7|
70909175|NCT02325713|141307057|SUPERIORITY_OR_OTHER||Geometric LS mean ration|82.1|||||TWO_SIDED|90.0|68.5|98.3||||||||98.3|68.5|
70909176|NCT03824535|141307104|SUPERIORITY|||||||0.02||||||The threshold for statistical significance was set at p \< 0.05|Wilcoxon (Mann-Whitney)|||Analysis applies to the row 'Specificity' in the Outcome Measure data table.||||0.02
70909177|NCT03824535|141307105|SUPERIORITY|||||||0.004||||||The threshold for statistical significance was predefined as p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.004
70909178|NCT03824535|141307105|SUPERIORITY|||||||0.05||||||The threshold for statistical significance was predefined as p ≤ 0.05.|Wilcoxon (Mann-Whitney)|||||||0.05
70909179|NCT03824535|141307105|SUPERIORITY|||||||0.06||||||The threshold for statistical significance was predefined as p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||0.06
70909180|NCT00322868|141307106|SUPERIORITY_OR_OTHER|||||||0.2772|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum white cell count||||||0.2772
70909181|NCT00322868|141307107|SUPERIORITY_OR_OTHER|||||||0.2467|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum neutrophil count||||||0.2467
70909182|NCT00322868|141307108|SUPERIORITY_OR_OTHER|||||||0.0288|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in sputum percent neutrophils||||||0.0288
70909183|NCT00322868|141307109|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum active elastase||||||0.50
70909184|NCT00322868|141307110|SUPERIORITY_OR_OTHER|||||||0.62|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum TNFα||||||0.62
70909185|NCT00322868|141307111|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum IL-1ß||||||0.50
70909186|NCT00322868|141307112|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum IL-6||||||0.55
70909187|NCT00322868|141307113|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum IL-8||||||0.75
70909188|NCT03639675|141307142|OTHER||Mean change|-8.3||||0.0004|TWO_SIDED|95.0|-12.2|-4.4|||one-sample t-statistics|||||-4.4|-12.2|0.0004
70909189|NCT02459587|141307144|SUPERIORITY|Survival analysis using start/stop counting method to identify time until event, structured to allow for multiple events per person. VCL contacts with and without suicide ideation were combined, due to low counts.|Hazard Ratio (HR)|1.24|STANDARD_ERROR_OF_MEAN|0.222||0.33|TWO_SIDED|95.0|0.8|1.92||2-tailed P-value above was calculated from type III test.|Regression, Cox|Model was structured to allow multiple events per person. No covariates.|Model was structured to allow multiple events per person. No covariates. HR based on parameter estimate = -0.218 (SEM=0.222)|||1.92|0.80|0.33
70909190|NCT02459587|141307145|SUPERIORITY|Survival analysis using start/stop counting method to identify time until event, structured to allow for multiple events per person.|Hazard Ratio (HR)|0.52|STANDARD_ERROR_OF_MEAN|0.153|<|0.0001|TWO_SIDED|95.0|0.38|0.7||All tests of significance were 2-tailed. P-value above is type III. No covariates.|Regression, Cox||Cox Proportional Hazards Model was structured to allow multiple events per person. No covariates. HR based on parameter estimate = -0.660 (SEM=0.153)|||0.70|0.38|<0.0001
70909191|NCT02459587|141307146|SUPERIORITY|Two binary variables were derived from Treatment Services Review responses to identify any general mental health service utilization, one binary variable for Baseline and another for any outpatient mental health service utilization at any time point in the 1 year follow-up period. The Baseline variable was included as a main-effects covariate.|Odds Ratio, log|1.146||||0.66|TWO_SIDED|95.0|0.604|2.176|||Regression, Logistic|Bivariate logistic, adjusted for (1) if any general outpatient mental heath visits at baseline (0) otherwise||||2.176|0.604|0.66
70909192|NCT02264574|141307147|SUPERIORITY||Hazard Ratio (HR)|0.231|||<|0.0001|TWO_SIDED|95.0|0.145|0.367|||Log Rank|The treatment effect was tested with an unstratified log rank test.|The hazard ratio and its 95% confidence interval were estimated using a Cox regression model with treatment as the only covariate.|To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||0.367|0.145|<0.0001
70909193|NCT02264574|141307148|SUPERIORITY||Hazard Ratio (HR)|0.119|||<|0.0001|TWO_SIDED|95.0|0.046|0.307|||Log Rank|The treatment effect was tested with an unstratified log rank test.|The hazard ratio and its 95% confidence interval were estimated using a Cox regression model with treatment as the only covariate.|To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||0.307|0.046|< 0.0001
70909194|NCT02264574|141307149|SUPERIORITY|||||||0.5253|||||||Chi-squared|||To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||||0.5253
70909195|NCT02264574|141307150|SUPERIORITY|||||||0.5465|||||||Chi-squared|||To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||||0.5465
70909196|NCT02264574|141307151|SUPERIORITY||Rate Ratio|1.208||||0.0035|TWO_SIDED|95.0|1.062|1.373|||Chi-squared|||To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||1.373|1.062|0.0035
70909197|NCT02264574|141307152|SUPERIORITY||Hazard Ratio (HR)|0.921||||0.8057|TWO_SIDED|95.0|0.479|1.772|||Log Rank|The treatment effect was tested with an unstratified log rank test.|The hazard ratio and its 95% confidence interval were estimated using a Cox regression model with treatment as the only covariate.|To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||1.772|0.479|0.8057
70909198|NCT02264574|141307153|SUPERIORITY|||||||0.0835|||||||Fisher Exact|||"IRR Preferred Term~To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record."||||0.0835
70909199|NCT02264574|141307153|SUPERIORITY|||||||0.1944|||||||Fisher Exact|||"IRR By Customized SMQ~To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record."||||0.1944
70909200|NCT02264574|141307154|SUPERIORITY|||||||0.0045|||||||Chi-squared|||To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||||0.0045
70909201|NCT02264574|141307155|SUPERIORITY|||||||0.859|||||||Chi-squared|||To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||||0.8590
70909202|NCT02264574|141307156|SUPERIORITY||Hazard Ratio (HR)|0.169|||<|0.0001|TWO_SIDED|95.0|0.102|0.282|||Log Rank|The treatment effect was tested with an unstratified log rank test.|The hazard ratio and its 95% confidence interval were estimated using a Cox regression model with treatment as the only covariate.|||0.282|0.102|< 0.0001
70909203|NCT02264574|141307157|SUPERIORITY|||||||0.9657|||||||Chi-squared|||||||0.9657
70909204|NCT02264574|141307158|SUPERIORITY|||||||0.1612|||||||Chi-squared|||||||0.1612
70909205|NCT02264574|141307159|SUPERIORITY||Rate Ratio|1.125||||0.0273|TWO_SIDED|95.0|1.013|1.25|||Chi-squared|||||1.250|1.013|0.0273
70909206|NCT02264574|141307160|SUPERIORITY||Hazard Ratio (HR)|1.083||||0.7934|TWO_SIDED|95.0|0.595|1.973|||Log Rank|The treatment effect was tested with an unstratified log rank test.|The hazard ratio and its 95% confidence interval were estimated using a Cox regression model with treatment as the only covariate.|||1.973|0.595|0.7934
70909207|NCT02264574|141307161|SUPERIORITY|||||||0.005|||||||Chi-squared|||||||0.0050
70909208|NCT02264574|141307162|SUPERIORITY||Hazard Ratio (HR)|0.251|||<|0.0001|TWO_SIDED|95.0|0.162|0.389|||Log Rank|The treatment effect was tested with an unstratified log rank test.|The hazard ratio and its 95% confidence interval were estimated using a Cox regression model with treatment as the only covariate.|||0.389|0.162|< 0.0001
70925902|NCT03637660|141345666|NON_INFERIORITY|The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.|Difference of proportion of participants|-0.06||||0.002|TWO_SIDED|90.0|-0.15|0.03||P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) by Farrington-Manning method with a 10% margin.|Farrington-Manning||The 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) by Farrington-Manning method with a 10% margin.|To assess the primary efficacy endpoint, the number and proportion of participants with a serological response by Month 6 and the 95% confidence interval were summarized overall and by treatment. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis for the primary objective was that the difference in proportion of participants with serological responses between the three-dose and one-dose groups was at least 10%||0.03|-0.15|0.002
70970022|NCT02873936|141445725|SUPERIORITY||Least Squares Mean Difference|4.6|STANDARD_ERROR_OF_MEAN|1.28|<|0.001|TWO_SIDED|95.0|2.1|7.1||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||7.1|2.1|<0.001
70970023|NCT02873936|141445725|SUPERIORITY||Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|1.3||0.11|TWO_SIDED|95.0|-0.5|4.7||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.7|-0.5|0.11
70970024|NCT02873936|141445728|SUPERIORITY||Least Squares Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|2.5||0.009|TWO_SIDED|95.0|2.0|11.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||11.0|2.0|0.009
70970025|NCT02873936|141445728|SUPERIORITY||Least Squares Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|2.5||0.003|TWO_SIDED|95.0|3.0|12.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||12.0|3.0|0.003
70970026|NCT02873936|141445728|SUPERIORITY||Least Squares Mean Difference|8.0|STANDARD_ERROR_OF_MEAN|2.6||0.003|TWO_SIDED|95.0|3.0|13.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||13.0|3.0|0.003
70970027|NCT02873936|141445728|SUPERIORITY||Least Squares Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|2.6||0.006|TWO_SIDED|95.0|2.0|12.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||12.0|2.0|0.006
70970028|NCT02873936|141445728|SUPERIORITY||Least Squares Mean Difference|9.0|STANDARD_ERROR_OF_MEAN|2.9||0.002|TWO_SIDED|95.0|3.0|15.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||15.0|3.0|0.002
70970029|NCT02873936|141445728|SUPERIORITY||Least Squares Mean Difference|8.0|STANDARD_ERROR_OF_MEAN|2.9||0.007|TWO_SIDED|95.0|2.0|14.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||14.0|2.0|0.007
70970030|NCT01225731|141445746|SUPERIORITY_OR_OTHER||% Difference in Response Rate|28.89||||0.001|TWO_SIDED|95.0|13.41|44.36|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||44.36|13.41|0.001
70970031|NCT01225731|141445746|SUPERIORITY_OR_OTHER||% Difference in Response Rate|60.0|||<|0.001|TWO_SIDED|95.0|48.42|71.58|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||71.58|48.42|<0.001
70925903|NCT03637660|141345674|EQUIVALENCE|The alternative hypothesis was that the two treatment groups were unequal.|||||<|0.001||||||P-value was calculated based on 2-sided Pearson Chi-Square test. Difference in proportion was reported with the Wilson 95% CI|Chi-squared|||The number and proportion of participants who were compliant to the treatment, receiving all assigned doses within the assigned visit windows. The null hypothesis was no difference between two treatment groups.||||< 0.001
70970032|NCT01225731|141445746|SUPERIORITY_OR_OTHER||% Difference in Response Rate|61.85|||<|0.001|TWO_SIDED|95.0|50.33|73.37|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||73.37|50.33|<0.001
70970033|NCT01225731|141445746|SUPERIORITY_OR_OTHER||% Difference in Response Rate|69.97|||<|0.001|TWO_SIDED|95.0|58.96|80.99|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||80.99|58.96|<0.001
70970034|NCT01225731|141445747|SUPERIORITY_OR_OTHER||% Difference in Response Rate|19.37||||0.009|TWO_SIDED|95.0|5.15|33.58|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||33.58|5.15|0.009
70970035|NCT01225731|141445747|SUPERIORITY_OR_OTHER||% Difference in Response Rate|54.44|||<|0.001|TWO_SIDED|95.0|42.63|66.26|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||66.26|42.63|<0.001
70970036|NCT01225731|141445747|SUPERIORITY_OR_OTHER||% Difference in Response Rate|56.23|||<|0.001|TWO_SIDED|95.0|44.43|68.03|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||68.03|44.43|<0.001
70970037|NCT01225731|141445747|SUPERIORITY_OR_OTHER||% Difference in Response Rate|67.65|||<|0.001|TWO_SIDED|95.0|56.42|78.88|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||78.88|56.42|<0.001
70909209|NCT02096081|141307173|NON_INFERIORITY_OR_EQUIVALENCE|"The analysis of response defined as the difference (D) in response rates between two treatment groups at 1 month was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group. The hypothesis testing procedure to test the equivalence of the two products is as follows:~Ho (null): D ≤ -∆ OR D ≥ ∆ versus Ha (alternate): -∆ \< D \< ∆, where ∆ is the margin of equivalence = 0.15."|Difference in proportions of response|-3.5|||||TWO_SIDED|95.0|-7.5|0.6|||||If the confidence interval lies within the limits of ±0.15, then Ho is rejected in favor of Ha (i.e., equivalence of incobotulinumtoxinA and onabotulinumtoxinA can be concluded); otherwise, treatment equivalence cannot be concluded.|With assumptions of an alpha of 5%, an equivalence margin of 15% for each side, the real response rate expected as 90% for incobotulinumtoxinA and onabotulinumtoxinA at day 30 and a 1:1 allocation ratio, a total of 225 subjects were needed to achieve a statistical power of 90% in order to make an equivalence conclusion at day 30. Results are based on the Newcombe-Wilson confidence interval. To account for exclusions from the PPS of about 10%, approximately 250 subjects were enrolled.||0.6|-7.5|
70909210|NCT02096081|141307174|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 2 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-5.3|||||TWO_SIDED|95.0|-12.1|1.5|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||1.5|-12.1|
70909211|NCT02096081|141307175|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 3 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-0.5|||||TWO_SIDED|95.0|-10.6|9.6|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||9.6|-10.6|
70909212|NCT02096081|141307176|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 4 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-5.2|||||TWO_SIDED|95.0|-17.4|7.1|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||7.1|-17.4|
70909213|NCT02096081|141307177|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 1 month was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-2.7|||||TWO_SIDED|95.0|-8.5|3.2|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||3.2|-8.5|
70909214|NCT02096081|141307178|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 2 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-2.8|||||TWO_SIDED|95.0|-11.0|5.3|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||5.3|-11.0|
70909215|NCT02096081|141307179|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 3 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-1.5|||||TWO_SIDED|95.0|-12.4|9.5|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||9.5|-12.4|
70909216|NCT02096081|141307180|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 4 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-1.9|||||TWO_SIDED|95.0|-14.4|10.7|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||10.7|-14.4|
70909217|NCT02886728|141307187|SUPERIORITY||Difference in Response Rates|9.6|||<|0.001|TWO_SIDED|95.0|3.6|15.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24||15.6|3.6|<0.001
70909218|NCT02886728|141307187|SUPERIORITY||Difference in Response Rates|8.8||||0.017|TWO_SIDED|95.0|1.5|16.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24||16.1|1.5|0.017
70909219|NCT02886728|141307187|SUPERIORITY||Difference in Response Rates|6.7||||0.058|TWO_SIDED|95.0|-0.7|14.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24||14.1|-0.7|0.058
70909220|NCT02886728|141307188|SUPERIORITY||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.041|<|0.001|TWO_SIDED|95.0|-0.27|-0.11||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from mixed effects model for repeated measures (MMRM). Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.11|-0.27|<0.001
70909221|NCT02886728|141307188|SUPERIORITY||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.049||0.009|TWO_SIDED|95.0|-0.23|-0.03||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.03|-0.23|0.009
70909222|NCT02886728|141307188|SUPERIORITY||Least Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.05||0.032|TWO_SIDED|95.0|-0.2|-0.01||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.01|-0.20|0.032
70909223|NCT02886728|141307189|SUPERIORITY||Difference in Response Rates|25.0|||<|0.001|TWO_SIDED|95.0|18.3|31.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24||31.7|18.3|<0.001
70909224|NCT02886728|141307189|SUPERIORITY||Difference in Response Rates|13.4|||<|0.001|TWO_SIDED|95.0|5.0|21.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24||21.8|5.0|<0.001
70909225|NCT02886728|141307189|SUPERIORITY||Difference in Response Rates|13.3|||<|0.001|TWO_SIDED|95.0|5.0|21.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24||21.6|5.0|<0.001
70909226|NCT02886728|141307190|SUPERIORITY||Least Squares Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.161||0.068|TWO_SIDED|95.0|-0.61|0.02||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.02|-0.61|0.068
70909227|NCT02886728|141307190|SUPERIORITY||Least Squares Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.195||0.14|TWO_SIDED|95.0|-0.67|0.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.10|-0.67|0.14
70909228|NCT02886728|141307190|SUPERIORITY||Least Squares Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.199||0.006|TWO_SIDED|95.0|-0.94|-0.16||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.16|-0.94|0.006
70909229|NCT02886728|141307191|SUPERIORITY||Least Squares Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|1.8|4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.0|1.8|<0.001
70909230|NCT02886728|141307191|SUPERIORITY||Least Squares Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|0.69||0.021|TWO_SIDED|95.0|0.2|2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.9|0.2|0.021
70909231|NCT02886728|141307191|SUPERIORITY||Least Squares Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.69||0.24|TWO_SIDED|95.0|-0.5|2.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.2|-0.5|0.24
70909232|NCT02886728|141307192|SUPERIORITY||Least Squares Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.68||0.056|TWO_SIDED|95.0|0.0|2.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.6|-0.0|0.056
70970038|NCT01225731|141445748|SUPERIORITY_OR_OTHER||% Difference in Response Rate|31.11|||<|0.001|TWO_SIDED|95.0|16.22|46.0|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||46.0|16.22|<0.001
70970039|NCT01225731|141445748|SUPERIORITY_OR_OTHER||% Difference in Response Rate|55.56|||<|0.001|TWO_SIDED|95.0|44.48|66.63|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||66.63|44.48|<0.001
70909233|NCT02886728|141307192|SUPERIORITY||Least Squares Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.82||0.1|TWO_SIDED|95.0|-0.3|3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.0|-0.3|0.10
70970040|NCT01225731|141445748|SUPERIORITY_OR_OTHER||% Difference in Response Rate|59.58|||<|0.001|TWO_SIDED|95.0|48.6|70.55|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||70.55|48.60|<0.001
70970041|NCT01225731|141445748|SUPERIORITY_OR_OTHER||% Difference in Response Rate|72.2|||<|0.001|TWO_SIDED|95.0|62.02|82.37|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||82.37|62.02|<0.001
70970042|NCT04341441|141445759|SUPERIORITY|Sample size was determined with one planned interim analysis when 50% of participants had completed their 8 weeks of treatment using an O'Brien-Fleming alpha spending method to ensure an overall type 1 error of 0.05. With a sample size of 900 per group and alpha = 0.0492, the power to detect a 32% reduction in COVID-19 disease rate (10% vs 6.8%) between the placebo and HCQ treated groups, determined at 87%. Study required 1000 per group with a total of 3000 patients to complete the trial.|Risk Ratio (RR)|0.32||||0.75|TWO_SIDED|||||P-value for the comparison between groups, including the non-randomized active comparator, was 0.75.|Mantel Haenszel||Low number of primary events precluded estimated value of risk ratio.|||||0.75
70970043|NCT01692275|141445775|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-1.4|-0.7||||||All sites combined (week 6) - Between-group differences of mean in LBP||-0.7|-1.4|
70970044|NCT01692275|141445775|SUPERIORITY||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-1.2|-0.5||||||All sites combined (week 12) - Between-group differences of mean in LBP||-0.5|-1.2|
70909234|NCT02886728|141307192|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.83||0.67|TWO_SIDED|95.0|-1.3|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-1.3|0.67
70909235|NCT02886728|141307193|SUPERIORITY||Least Squares Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.195|<|0.001|TWO_SIDED|95.0|-1.03|-0.27||MMRM model included treatment, visit, treatment by visit, stratification factors, campaign groups, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.27|-1.03|<0.001
70909236|NCT02886728|141307193|SUPERIORITY||Least Squares Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.236||0.008|TWO_SIDED|95.0|-1.09|-0.16||MMRM model included treatment, visit, treatment by visit, stratification factors, campaign groups, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.16|-1.09|0.008
70970045|NCT01692275|141445775|SUPERIORITY||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-1.3|-0.1||||||Walter Reed site (week 6) - Between-group differences of mean in LBP||-0.1|-1.3|
70909237|NCT02886728|141307193|SUPERIORITY||Least Squares Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.242||0.006|TWO_SIDED|95.0|-1.14|-0.19||MMRM model included treatment, visit, treatment by visit, stratification factors, campaign groups, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.19|-1.14|0.006
70909238|NCT02886728|141307194|SUPERIORITY||Difference in Response Rates|25.5|||<|0.001|TWO_SIDED|95.0|19.3|31.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2||31.7|19.3|<0.001
70909239|NCT02886728|141307194|SUPERIORITY||Difference in Response Rates|20.6|||<|0.001|TWO_SIDED|95.0|12.8|28.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2||28.5|12.8|<0.001
70970046|NCT01692275|141445775|SUPERIORITY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-1.0|0.2||||||Walter Reed site (week 12) - Between-group differences of mean in LBP||0.2|-1.0|
70970047|NCT01692275|141445775|SUPERIORITY||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-1.8|-0.6||||||Naval Hospital Pensacola site (week 6) - Between-group differences of mean in LBP||-0.6|-1.8|
70909240|NCT02886728|141307194|SUPERIORITY||Difference in Response Rates|22.9|||<|0.001|TWO_SIDED|95.0|15.1|30.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2||30.8|15.1|<0.001
70909241|NCT02886728|141307194|SUPERIORITY||Difference in Response Rates|28.8|||<|0.001|TWO_SIDED|95.0|22.1|35.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4||35.6|22.1|<0.001
70909242|NCT02886728|141307194|SUPERIORITY||Difference in Response Rates|22.1|||<|0.001|TWO_SIDED|95.0|13.6|30.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4||30.7|13.6|<0.001
70909243|NCT02886728|141307194|SUPERIORITY||Difference in Response Rates|19.0|||<|0.001|TWO_SIDED|95.0|10.5|27.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4||27.5|10.5|<0.001
70909244|NCT02886728|141307194|SUPERIORITY||Difference in Response Rates|17.3|||<|0.001|TWO_SIDED|95.0|10.8|23.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12||23.8|10.8|<0.001
70970048|NCT01692275|141445775|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-1.8|-0.5||||||Naval Hospital Pensacola site (week 12) - Between-group differences of mean in LBP||-0.5|-1.8|
70970049|NCT01692275|141445775|SUPERIORITY||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-1.9|-0.8||||||Naval Medical Center San Diego site (week 6) - Between-group differences of mean in LBP||-0.8|-1.9|
70970050|NCT01692275|141445775|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-1.7|-0.5||||||Naval Medical Center San Diego (week 12) - Between-group differences of mean in LBP||-0.5|-1.7|
70970051|NCT01692275|141445776|SUPERIORITY||Mean Difference (Final Values)|-2.2|||||TWO_SIDED|95.0|-3.1|-1.2||||||All sites combined (week 6) - RMDQ Between-Group Differences in Disability||-1.2|-3.1|
70909245|NCT02886728|141307194|SUPERIORITY||Difference in Response Rates|12.6||||0.002|TWO_SIDED|95.0|4.5|20.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12||20.7|4.5|0.002
70909246|NCT02886728|141307194|SUPERIORITY||Difference in Response Rates|12.1||||0.002|TWO_SIDED|95.0|4.0|20.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12||20.1|4.0|0.002
70909247|NCT02886728|141307194|SUPERIORITY||Difference in Response Rates|7.2||||0.016|TWO_SIDED|95.0|0.9|13.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36||13.5|0.9|0.016
70909248|NCT02886728|141307194|SUPERIORITY||Difference in Response Rates|5.2||||0.18|TWO_SIDED|95.0|-2.7|13.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36||13.0|-2.7|0.18
70909249|NCT02886728|141307194|SUPERIORITY||Difference in Response Rates|7.9||||0.03|TWO_SIDED|95.0|0.3|15.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36||15.6|0.3|0.030
70909250|NCT02886728|141307194|SUPERIORITY||Difference in Response Rates|13.2|||<|0.001|TWO_SIDED|95.0|6.7|19.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52||19.7|6.7|<0.001
70909251|NCT02886728|141307194|SUPERIORITY||Difference in Response Rates|11.7||||0.003|TWO_SIDED|95.0|3.7|19.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52||19.6|3.7|0.003
70909252|NCT02886728|141307194|SUPERIORITY||Difference in Response Rates|13.0|||<|0.001|TWO_SIDED|95.0|5.1|20.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52||20.8|5.1|<0.001
70909253|NCT02886728|141307195|SUPERIORITY||Difference in Response Rates|10.1|||<|0.001|TWO_SIDED|95.0|6.2|13.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2||13.9|6.2|<0.001
70970052|NCT01692275|141445776|SUPERIORITY||Mean Difference (Final Values)|-2.0|||||TWO_SIDED|95.0|-3.0|-1.0||||||All sites combined (week 12) - RMDQ Between-Group Differences in Disability||-1.0|-3.0|
70909254|NCT02886728|141307195|SUPERIORITY||Difference in Response Rates|6.3||||0.001|TWO_SIDED|95.0|1.7|10.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2||10.9|1.7|0.001
70909255|NCT02886728|141307195|SUPERIORITY||Difference in Response Rates|13.3|||<|0.001|TWO_SIDED|95.0|7.7|18.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2||18.9|7.7|<0.001
70909256|NCT02886728|141307195|SUPERIORITY||Difference in Response Rates|20.0|||<|0.001|TWO_SIDED|95.0|14.5|25.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4||25.4|14.5|<0.001
70909257|NCT02886728|141307195|SUPERIORITY||Difference in Response Rates|11.4|||<|0.001|TWO_SIDED|95.0|4.8|18.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4||18.0|4.8|<0.001
70909258|NCT02886728|141307195|SUPERIORITY||Difference in Response Rates|16.3|||<|0.001|TWO_SIDED|95.0|9.4|23.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4||23.2|9.4|<0.001
70909259|NCT02886728|141307195|SUPERIORITY||Difference in Response Rates|24.8|||<|0.001|TWO_SIDED|95.0|18.1|31.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12||31.5|18.1|<0.001
70909260|NCT02886728|141307195|SUPERIORITY||Difference in Response Rates|16.1|||<|0.001|TWO_SIDED|95.0|7.7|24.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12||24.5|7.7|<0.001
70909261|NCT02886728|141307195|SUPERIORITY||Difference in Response Rates|17.3|||<|0.001|TWO_SIDED|95.0|9.0|25.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12||25.7|9.0|<0.001
70909262|NCT02886728|141307195|SUPERIORITY||Difference in Response Rates|15.9|||<|0.001|TWO_SIDED|95.0|8.9|22.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24||22.8|8.9|<0.001
70909263|NCT02886728|141307195|SUPERIORITY||Difference in Response Rates|11.3||||0.006|TWO_SIDED|95.0|2.7|20.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24||20.0|2.7|0.006
70909264|NCT02886728|141307195|SUPERIORITY||Difference in Response Rates|12.4||||0.002|TWO_SIDED|95.0|3.9|21.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24||21.0|3.9|0.002
70909265|NCT02886728|141307195|SUPERIORITY||Difference in Response Rates|12.0|||<|0.001|TWO_SIDED|95.0|5.1|19.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36||19.0|5.1|<0.001
70909266|NCT02886728|141307195|SUPERIORITY||Difference in Response Rates|7.0||||0.09|TWO_SIDED|95.0|-1.7|15.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36||15.7|-1.7|0.090
70909267|NCT02886728|141307195|SUPERIORITY||Difference in Response Rates|10.0||||0.014|TWO_SIDED|95.0|1.4|18.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36||18.6|1.4|0.014
70909268|NCT02886728|141307195|SUPERIORITY||Difference in Response Rates|13.9|||<|0.001|TWO_SIDED|95.0|7.0|20.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52||20.9|7.0|<0.001
70909269|NCT02886728|141307195|SUPERIORITY||Difference in Response Rates|11.1||||0.008|TWO_SIDED|95.0|2.5|19.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52||19.7|2.5|0.008
70909270|NCT02886728|141307195|SUPERIORITY||Difference in Response Rates|13.1||||0.001|TWO_SIDED|95.0|4.6|21.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52||21.6|4.6|0.001
70909271|NCT02886728|141307196|SUPERIORITY||Difference in Response Rates|2.4||||0.018|TWO_SIDED|95.0|0.3|4.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2||4.5|0.3|0.018
70909272|NCT02886728|141307196|SUPERIORITY||Difference in Response Rates|1.2||||0.17|TWO_SIDED|95.0|-1.2|3.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2||3.6|-1.2|0.17
70909273|NCT02886728|141307196|SUPERIORITY||Difference in Response Rates|3.6||||0.004|TWO_SIDED|95.0|0.3|6.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2||6.8|0.3|0.004
70909274|NCT02886728|141307196|SUPERIORITY||Difference in Response Rates|9.1|||<|0.001|TWO_SIDED|95.0|5.2|13.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4||13.1|5.2|<0.001
70909275|NCT02886728|141307196|SUPERIORITY||Difference in Response Rates|2.4||||0.18|TWO_SIDED|95.0|-1.7|6.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4||6.6|-1.7|0.18
70970053|NCT01692275|141445776|SUPERIORITY||Mean Difference (Final Values)|-1.8|||||TWO_SIDED|95.0|-3.4|-0.2||||||Walter Reed site (week 6) - RMDQ Between-Group Differences in Disability||-0.2|-3.4|
70909276|NCT02886728|141307196|SUPERIORITY||Difference in Response Rates|7.6|||<|0.001|TWO_SIDED|95.0|2.5|12.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4||12.6|2.5|<0.001
70909277|NCT02886728|141307196|SUPERIORITY||Difference in Response Rates|19.7|||<|0.001|TWO_SIDED|95.0|13.9|25.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12||25.5|13.9|<0.001
70909278|NCT02886728|141307196|SUPERIORITY||Difference in Response Rates|13.8|||<|0.001|TWO_SIDED|95.0|6.6|21.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12||21.1|6.6|<0.001
70909279|NCT02886728|141307196|SUPERIORITY||Difference in Response Rates|15.8|||<|0.001|TWO_SIDED|95.0|8.5|23.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12||23.1|8.5|<0.001
70909280|NCT02886728|141307196|SUPERIORITY||Difference in Response Rates|17.8|||<|0.001|TWO_SIDED|95.0|11.2|24.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24||24.4|11.2|<0.001
70909281|NCT02886728|141307196|SUPERIORITY||Difference in Response Rates|14.1|||<|0.001|TWO_SIDED|95.0|5.9|22.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24||22.4|5.9|<0.001
70909282|NCT02886728|141307196|SUPERIORITY||Difference in Response Rates|14.0|||<|0.001|TWO_SIDED|95.0|5.8|22.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24||22.2|5.8|<0.001
70909283|NCT02886728|141307196|SUPERIORITY||Difference in Response Rates|13.7|||<|0.001|TWO_SIDED|95.0|6.9|20.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36||20.5|6.9|<0.001
70909284|NCT02886728|141307196|SUPERIORITY||Difference in Response Rates|5.0||||0.2|TWO_SIDED|95.0|-3.3|13.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36||13.3|-3.3|0.20
70909285|NCT02886728|141307196|SUPERIORITY||Difference in Response Rates|7.3||||0.056|TWO_SIDED|95.0|-1.0|15.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36||15.7|-1.0|0.056
70909286|NCT02886728|141307196|SUPERIORITY||Difference in Response Rates|18.0|||<|0.001|TWO_SIDED|95.0|11.3|24.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52||24.8|11.3|<0.001
70909287|NCT02886728|141307196|SUPERIORITY||Difference in Response Rates|10.3||||0.01|TWO_SIDED|95.0|1.9|18.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52||18.6|1.9|0.010
70909288|NCT02886728|141307196|SUPERIORITY||Difference in Response Rates|15.4|||<|0.001|TWO_SIDED|95.0|7.0|23.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52||23.8|7.0|<0.001
70970054|NCT01692275|141445776|SUPERIORITY||Mean Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-3.2|0.2||||||Walter Reed site (week 12) - RMDQ Between-Group Differences in Disability||0.2|-3.2|
70970055|NCT01692275|141445776|SUPERIORITY||Mean Difference (Final Values)|-2.1|||||TWO_SIDED|95.0|-3.8|-0.4||||||Pensacola site (week 6) - RMDQ Between-Group Differences in Disability||-0.4|-3.8|
70970056|NCT01692275|141445776|SUPERIORITY||Mean Difference (Final Values)|-1.9|||||TWO_SIDED|95.0|-3.7|-0.2||||||Pensacola site (week 12) - RMDQ Between-Group Differences in Disability||-0.2|-3.7|
70970057|NCT01692275|141445776|SUPERIORITY||Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-4.3|-1.1||||||San Diego site (week 6) - RMDQ Between-Group Differences in Disability||-1.1|-4.3|
70970058|NCT01692275|141445776|SUPERIORITY||Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-4.4|-1.1||||||San Diego site (week 12) - RMDQ Between-Group Differences in Disability||-1.1|-4.4|
70970059|NCT01692275|141445777|SUPERIORITY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-0.6|-0.2||||||All sites combined (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP||-0.2|-0.6|
70970060|NCT01692275|141445777|SUPERIORITY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-0.6|-0.2||||||All sites combined (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP||-0.2|-0.6|
70970061|NCT01692275|141445777|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.5|0.1||||||Walter Reed site (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP||0.1|-0.5|
70970062|NCT01692275|141445777|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.5|0.1||||||Walter Reed site (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP||0.1|-0.5|
70970063|NCT01692275|141445777|SUPERIORITY||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-0.8|-0.2||||||Pensacola site (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP||-0.2|-0.8|
70970064|NCT01692275|141445777|SUPERIORITY||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-0.8|-0.2||||||Pensacola site (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP||-0.2|-0.8|
70970065|NCT01692275|141445777|SUPERIORITY||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-0.7|-0.2||||||San Diego site (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP||-0.2|-0.7|
70970066|NCT01692275|141445777|SUPERIORITY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-0.7|-0.1||||||San Diego site (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP||-0.1|-0.7|
70970067|NCT01692275|141445778|SUPERIORITY||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-1.6|-0.8||||||All sites combined (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.8|-1.6|
70970068|NCT01692275|141445778|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-1.6|-0.7||||||All sites combined (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.7|-1.6|
70970069|NCT01692275|141445778|SUPERIORITY||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-1.3|-0.02||||||Walter Reed site (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.02|-1.3|
70970070|NCT01692275|141445778|SUPERIORITY||Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-1.5|-0.1||||||Walter Reed site (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.1|-1.5|
70970071|NCT01692275|141445778|SUPERIORITY||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-2.0|-0.7||||||Pensacola site (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.7|-2.0|
70970072|NCT01692275|141445778|SUPERIORITY||Mean Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-2.3|-0.8||||||Pensacola site (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.8|-2.3|
71030661|NCT01029353|141569508|SUPERIORITY||Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.95|1.31|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.31|0.95|
70970073|NCT01692275|141445778|SUPERIORITY||Mean Difference (Final Values)|-1.6|||||TWO_SIDED|95.0|-2.3|-1.0||||||San Diego site (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-1.0|-2.3|
70970074|NCT01692275|141445778|SUPERIORITY||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-1.9|-0.5||||||San Diego site (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.5|-1.9|
70970075|NCT01692275|141445779|SUPERIORITY||Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.54|0.97||||||Week 6: All 3 sites combined||0.97|0.54|
70970076|NCT01692275|141445779|SUPERIORITY||Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.58|1.0||||||Week 12: All 3 sites combined||1.0|0.58|
70970077|NCT01692275|141445780|SUPERIORITY||Odds Ratio (OR)|0.18|||||TWO_SIDED|95.0|0.13|0.25||||||All sites combined: 6 weeks||0.25|0.13|
70970078|NCT01692275|141445780|SUPERIORITY||Odds Ratio (OR)|0.26|||||TWO_SIDED|95.0|0.16|0.42||||||Walter Reed site: 6 weeks||0.42|0.16|
70970079|NCT01692275|141445780|SUPERIORITY||Odds Ratio (OR)|0.18|||||TWO_SIDED|95.0|0.1|0.33||||||Naval Hospital Pensacola site: 6 weeks||0.33|0.10|
70970080|NCT01692275|141445780|SUPERIORITY||Odds Ratio (OR)|0.13|||||TWO_SIDED|95.0|0.08|0.21||||||Naval Medical Center San Diego site: 6 weeks||0.21|0.08|
70970081|NCT01692275|141445781|SUPERIORITY||Mean Difference (Final Values)|2.5|||||TWO_SIDED|95.0|2.1|2.8||||||All sites combined: 6 weeks||2.8|2.1|
70970082|NCT01692275|141445781|SUPERIORITY||Mean Difference (Final Values)|2.0|||||TWO_SIDED|95.0|1.4|2.6||||||Walter Reed site: 6 weeks||2.6|1.4|
70970083|NCT01692275|141445781|SUPERIORITY||Mean Difference (Final Values)|2.3|||||TWO_SIDED|95.0|1.6|3.0||||||Naval Hospital Pensacola site: 6 weeks||3.0|1.6|
70970084|NCT01692275|141445781|SUPERIORITY||Mean Difference (Final Values)|3.1|||||TWO_SIDED|95.0|2.5|3.7||||||Naval Medical Center San Diego site: 6 weeks||3.7|2.5|
71008710|NCT02055976|141525244|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.543|STANDARD_ERROR_OF_MEAN|2.876||0.002|TWO_SIDED|95.0|2.827|14.26|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||14.260|2.827|0.002
70909289|NCT02886728|141307197|SUPERIORITY||Least Squares Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.031|<|0.001|TWO_SIDED|95.0|-0.29|-0.17||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.17|-0.29|<0.001
70909290|NCT02886728|141307197|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.038|<|0.001|TWO_SIDED|95.0|-0.28|-0.13||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.13|-0.28|<0.001
70909291|NCT02886728|141307197|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.038|<|0.001|TWO_SIDED|95.0|-0.24|-0.09||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.09|-0.24|<0.001
70909292|NCT02886728|141307197|SUPERIORITY||Least Squares Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.035|<|0.001|TWO_SIDED|95.0|-0.35|-0.22||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.22|-0.35|<0.001
70909293|NCT02886728|141307197|SUPERIORITY||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.043|<|0.001|TWO_SIDED|95.0|-0.23|-0.06||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.06|-0.23|<0.001
70909294|NCT02886728|141307197|SUPERIORITY||Least Squares Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.042|<|0.001|TWO_SIDED|95.0|-0.29|-0.12||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.12|-0.29|<0.001
70909295|NCT02886728|141307197|SUPERIORITY||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.039|<|0.001|TWO_SIDED|95.0|-0.35|-0.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.20|-0.35|<0.001
70909296|NCT02886728|141307197|SUPERIORITY||Least Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.048|<|0.001|TWO_SIDED|95.0|-0.28|-0.09||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.09|-0.28|<0.001
71153639|NCT03563183|141799777|OTHER|VE against the BOI due to HZ (VE BOI ) was defined as the relative reduction in the BOI score in the vaccine group as compared with that in the placebo group and calculated as 1 - relative risk (i.e., 1- the HZ BOI score in the vaccine group divided by the HZ BOI score in the placebo group).|Vaccine Efficacy rate|98.6|||||TWO_SIDED|95.0|97.1|100.0||||||VE against confirmed HZ BOI and 95% confidence intervals (CIs) are presented by frailty status in the mTVC.||100|97.1|
70909297|NCT02886728|141307197|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.048|<|0.001|TWO_SIDED|95.0|-0.26|-0.07||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.07|-0.26|<0.001
70909298|NCT02886728|141307197|SUPERIORITY||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.043||0.002|TWO_SIDED|95.0|-0.22|-0.05||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.05|-0.22|0.002
70909299|NCT02886728|141307197|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.052||0.23|TWO_SIDED|95.0|-0.17|0.04||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.04|-0.17|0.23
70909300|NCT02886728|141307197|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.052||0.24|TWO_SIDED|95.0|-0.16|0.04||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.04|-0.16|0.24
70909301|NCT02886728|141307197|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.045|<|0.001|TWO_SIDED|95.0|-0.25|-0.08||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.08|-0.25|<0.001
70909302|NCT02886728|141307197|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.054||0.077|TWO_SIDED|95.0|-0.2|0.01||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.01|-0.20|0.077
70909303|NCT02886728|141307197|SUPERIORITY||Least Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.054||0.039|TWO_SIDED|95.0|-0.22|-0.01||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.01|-0.22|0.039
70909304|NCT02886728|141307198|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|-6.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-6.0|<0.001
70909305|NCT02886728|141307198|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-6.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-6.0|<0.001
70909306|NCT02886728|141307198|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-7.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-7.0|<0.001
70909307|NCT02886728|141307198|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-7.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-7.0|<0.001
70909308|NCT02886728|141307198|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-6.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-6.0|<0.001
70909309|NCT02886728|141307198|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-7.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-7.0|<0.001
70909310|NCT02886728|141307198|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-5.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-5.0|<0.001
70909311|NCT02886728|141307198|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|-5.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-5.0|<0.001
70909312|NCT02886728|141307198|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|-6.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-6.0|<0.001
71153640|NCT03563183|141799777|OTHER|VE against the BOI due to HZ (VE BOI ) was defined as the relative reduction in the BOI score in the vaccine group as compared with that in the placebo group and calculated as 1 - relative risk (i.e., 1- the HZ BOI score in the vaccine group divided by the HZ BOI score in the placebo group).|Vaccine Efficacy rate|92.6|||||TWO_SIDED|95.0|86.6|98.7||||||VE against confirmed HZ BOI and 95% confidence intervals (CIs) are presented by frailty status in the mTVC.||98.7|86.6|
70909313|NCT02886728|141307198|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
70909314|NCT02886728|141307198|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6||0.005|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|0.005
70909315|NCT02886728|141307198|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|<0.001
70909316|NCT02886728|141307198|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.5||0.063|TWO_SIDED|95.0|-2.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.0|-2.0|0.063
70909317|NCT02886728|141307198|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.6||0.64|TWO_SIDED|95.0|-1.0|1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.0|-1.0|0.64
70909318|NCT02886728|141307198|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
70909319|NCT02886728|141307198|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
70909320|NCT02886728|141307198|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.6||0.095|TWO_SIDED|95.0|-2.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.0|-2.0|0.095
70909321|NCT02886728|141307198|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
70909322|NCT02886728|141307199|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
70909323|NCT02886728|141307199|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.7||0.002|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|0.002
70909324|NCT02886728|141307199|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|<0.001
71153641|NCT03563183|141799777|OTHER|VE against the BOI due to HZ (VE BOI ) was defined as the relative reduction in the BOI score in the vaccine group as compared with that in the placebo group and calculated as 1 - relative risk (i.e., 1- the HZ BOI score in the vaccine group divided by the HZ BOI score in the placebo group).|Vaccine Efficacy rate|85.2|||||TWO_SIDED|95.0|62.6|100.0||||||VE against confirmed HZ BOI and 95% confidence intervals (CIs) are presented by frailty status in the mTVC.||100|62.6|
70909325|NCT02886728|141307199|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-4.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|Mixed effects model for repeated measure|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-4.0|<0.001
70909326|NCT02886728|141307199|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|<0.001
70970085|NCT01033825|141445812|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be demonstrated if the 95% CI upper bound for the difference between ciclesonide and placebo with placebo dexamethasone (placebo minus ciclesonide) is \<Margin. In order to have 90% power to demonstrate non-inferiority of ciclesonide 320 μg to HFA placebo, 46 evaluable subjects per group are needed using a 1-sided alpha level of 0.025, a standard deviation of 55 μg h/dL, a non-inferiority margin of 38 μh /dL, assuming no true difference exists.|Mean Difference (Final Values)|-0.5|||>|0.05|TWO_SIDED|95.0|-13.9|13.0|||ANCOVA||Null Hypothesis: the difference in serum cortisol levels between placebo and active (placebo-active)\>=38 Alternative Hypothesis: the difference in serum cortisol levels between placebo and active (placebo-active)\<38|Standard bioequivalence bounds of a 20% difference based on the clinical judgment was used to determine the delta.||13.0|-13.9|>0.05
70970086|NCT01033825|141445812|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be demonstrated if the 95% CI upper bound for the difference between ciclesonide and placebo with placebo dexamethasone (placebo minus ciclesonide) is \<Margin. In order to have 90% power to demonstrate non-inferiority of ciclesonide 320 μg to HFA placebo, 46 evaluable subjects per group are needed using a 1-sided alpha level of 0.025, a standard deviation of 55 μg h/dL, a non-inferiority margin of 38 μh /dL, assuming no true difference exists.|Mean Difference (Final Values)|-2.4||||0.025|TWO_SIDED|95.0|-15.1|10.2|||ANCOVA|||Standard bioequivalence bounds of a 20% difference based on the clinical judgment was used to determine the delta.||10.2|-15.1|0.025
70970087|NCT01033825|141445812|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be demonstrated if the 95% CI upper bound for the difference between ciclesonide and placebo with placebo dexamethasone (placebo minus ciclesonide) is \<Margin. In order to have 90% power to demonstrate non-inferiority of ciclesonide nasal spray 200 μg to placebo nasal spray 46 evaluable (per protocol) subjects per group are needed using a 1-sided alpha level of 0.025, a standard deviation of 55 μg h/dL, a non-inferiority margin of 38 μh /dL|Mean Difference (Final Values)|10.4|||>|0.05|TWO_SIDED|95.0|-4.7|25.5|||ANCOVA|||Standard bioequivalence bounds of a 20% difference based on the clinical judgment was used to determine the delta.||25.5|-4.7|>0.05
70970088|NCT03099187|141445828|SUPERIORITY||Difference in Group Means|-134.6||||0.6777|TWO_SIDED|95.0|-772.4|503.3||p-value was not adjusted for multiplicity and is provided for descriptive purpose only|t-test, 2 sided|||Primary Analysis in 2019. Mean FVC decline comparison between treatment groups using a Student's t-test with a two-sided significance level of 0.05||503.3|-772.4|0.6777
70970089|NCT03099187|141445828|SUPERIORITY||Difference in Group Means|-216.0||||0.4682|TWO_SIDED|95.0|-803.6|371.7||p-value was not adjusted for multiplicity and is provided for descriptive purpose only|Student's t-test|||Final Analysis in 2020. Mean FVC decline comparison between treatment groups using a Student's t-test with a two-sided significance level of 0.05||371.7|-803.6|0.4682
70970090|NCT03099187|141445829|SUPERIORITY|||||||0.0383|||||||rank ANCOVA|||Primary Analysis in 2019||||0.0383
70970091|NCT03099187|141445829|SUPERIORITY|||||||0.0239|||||||rank ANCOVA|||Final Analysis in 2020||||0.0239
70909327|NCT02886728|141307199|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|<0.001
70909328|NCT02886728|141307199|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-3.0|<0.001
70970092|NCT03099187|141445830|SUPERIORITY||Overall Mean Difference|95.3||||0.0018|TWO_SIDED|95.0|35.9|154.6||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|Student's t-test|||Primary Analysis in 2019||154.6|35.9|0.0018
70970093|NCT03099187|141445830|SUPERIORITY||Overall Mean Difference|84.3||||0.0096|TWO_SIDED|95.0|20.7|147.8||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|Student's t-test|||Final Analysis in 2020||147.8|20.7|0.0096
71153642|NCT03563183|141799777|OTHER|VE against the BOI due to HZ (VE BOI ) was defined as the relative reduction in the BOI score in the vaccine group as compared with that in the placebo group and calculated as 1 - relative risk (i.e., 1- the HZ BOI score in the vaccine group divided by the HZ BOI score in the placebo group).|Vaccine Efficacy rate|100.0||||||||||||||VE against the BOI due to confirmed HZ. The 95% Confidence Interval was not calculated as there were no subjects reported with a confirmed Zoster episode in the Unknown-HZ/su Group.||||
70909329|NCT02886728|141307199|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
70970094|NCT03099187|141445831|SUPERIORITY||Odds Ratio (OR)|0.42||||0.0006|TWO_SIDED|95.0|0.25|0.69||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|Cochran-Mantel-Haenszel|||Primary Analysis in 2019||0.69|0.25|0.0006
70970095|NCT03099187|141445831|SUPERIORITY||Odds Ratio (OR)|0.43||||0.0009|TWO_SIDED|95.0|0.26|0.71||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|Cochran-Mantel-Haenszel|||Final Analysis in 2020||0.71|0.26|0.0009
70970096|NCT03099187|141445832|SUPERIORITY||Odds Ratio (OR)|0.44||||0.0114|TWO_SIDED|95.0|0.23|0.84||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|Cochran-Mantel-Haenszel|||Primary Analysis in 2019||0.84|0.23|0.0114
70970097|NCT03099187|141445832|SUPERIORITY||Odds Ratio (OR)|0.46||||0.0168|TWO_SIDED|95.0|0.24|0.88||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|Cochran-Mantel-Haenszel|||Final Analysis in 2020||0.88|0.24|0.0168
70970098|NCT03099187|141445833|SUPERIORITY|||||||0.0874||||||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|rank ANCOVA|||Primary Analysis in 2019||||0.0874
70970099|NCT03099187|141445833|SUPERIORITY|||||||0.1191||||||p-values are not adjusted for multiplicity and are provided for descriptive purpose only.|rank ANCOVA|||Final Analysis in 2020||||0.1191
70970100|NCT03099187|141445834|SUPERIORITY|||||||0.0395||||||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|rank ANCOVA|||Primary Analysis in 2019||||0.0395
70970101|NCT03099187|141445834|SUPERIORITY|||||||0.0299||||||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|rank ANCOVA|||Final Analysis in 2020||||0.0299
70970102|NCT03099187|141445835|SUPERIORITY||Hodges-Lehmann Median Difference|0.0||||0.7788|TWO_SIDED|95.0|-5.0|5.0|||rank ANCOVA|Analysis of Covariance Changes from baseline to week 24 are compared between the treatment arms using a rank ANCOVA.||Primary Analysis in 2019||5.00|-5.00|0.7788
70970103|NCT03099187|141445835|SUPERIORITY||Hodges-Lehmann Median Difference|0.0||||0.8289|TWO_SIDED|95.0|-5.0|5.0||Analysis of Covariance Changes from baseline to week 24 or early discontinuation visit are compared between the treatment arms using a rank ANCOVA with change from baseline as outcome variable and standardized rank baseline value as covariate|rank ANCOVA|||Final Analysis in 2020||5.00|-5.00|0.8289
70970104|NCT03099187|141445836|SUPERIORITY||Hodges-Lehmann Median difference|0.29||||0.1872|TWO_SIDED|95.0|-0.45|1.04||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|rank ANCOVA|Analysis of Covariance Changes from baseline to week 24 are compared between the treatment arms using a rank ANCOVA.||Primary Analysis in 2019||1.04|-0.45|0.1872
70970105|NCT03099187|141445836|SUPERIORITY||Hodges-Lehmann Median Difference|0.27||||0.2019|TWO_SIDED|95.0|-0.48|1.02||Analysis of Covariance Changes from baseline to week 24 or early discontinuation visit are compared between the treatment arms using a rank ANCOVA with change from baseline as outcome variable and standardized rank baseline value as covariate.|rank ANCOVA|||Final Analysis in 2020||1.02|-0.48|0.2019
70970106|NCT03099187|141445837|SUPERIORITY||Hodges-Lehmann Median Difference|-2.0||||0.2995|TWO_SIDED|95.0|-10.0|4.0|||rank ANCOVA|Analysis of Covariance Changes from baseline to week 24 are compared between the treatment arms using a rank ANCOVA.||Primary Analysis in 2019||4.00|-10.00|0.2995
70970107|NCT03099187|141445837|SUPERIORITY||Hodges-Lehmann Median Difference|-2.0||||0.3372|TWO_SIDED|95.0|-10.0|4.0||Analysis of Covariance Changes from baseline to week 24 or early discontinuation visit are compared between the treatment arms using a rank ANCOVA with change from baseline as outcome variable and standardized rank baseline value as covariate.|rank ANCOVA|||Final Analysis in 2020||4.00|-10.00|0.3372
70970108|NCT03099187|141445838|SUPERIORITY||Hodges-Lehmann Median Difference|-1.86||||0.163|TWO_SIDED|95.0|-5.06|1.38|||rank ANCOVA|Analysis of Covariance Changes from baseline to week 24 are compared between the treatment arms using a rank ANCOVA.||Primary Analysis in 2019||1.38|-5.06|0.1630
70970109|NCT03099187|141445838|SUPERIORITY||Hodges-Lehmann Median Difference|-1.74||||0.1851|TWO_SIDED|95.0|-5.0|1.55||Analysis of Covariance Changes from baseline to week 24 or early discontinuation visit are compared between the treatment arms using a rank ANCOVA with change from baseline as outcome variable and standardized rank baseline value as covariate.|rank ANCOVA|||Final Analysis in 2020||1.55|-5.00|0.1851
70970110|NCT03099187|141445839|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.5922|TWO_SIDED|95.0|0.59|2.49|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.|Hazard ratios and corresponding 95% CI are calculated by applying Cox-proportional hazard models.|Primary Analysis in 2019. All-cause non-elective hospitalization.||2.49|0.59|0.5922
70970111|NCT03099187|141445839|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.8057|TWO_SIDED|95.0|0.26|2.83|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.|Hazard ratios and corresponding 95% CI are calculated by applying Cox-proportional hazard models.|Primary Analysis in 2019. Respiratory non-elective hospitalization.||2.83|0.26|0.8057
70970112|NCT03099187|141445839|SUPERIORITY||Hazard Ratio (HR)|1.31||||0.4613|TWO_SIDED|95.0|0.63|2.73|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.|Hazard ratios and corresponding 95% CI are calculated by applying Cox-proportional hazard models|Final Analysis in 2020. All-cause non-elective hospitalization.||2.73|0.63|0.4613
70970113|NCT03099187|141445839|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9523|TWO_SIDED|95.0|0.3|3.59|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.|Hazard ratios and corresponding 95% CI are calculated by applying Cox-proportional hazard models.|Final Analysis in 2020. Respiratory non-elective hospitalization.||3.59|0.30|0.9523
70970114|NCT03099187|141445841|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.7871|TWO_SIDED|95.0|0.26|2.78|||Log Rank|||||2.78|0.26|0.7871
70970115|NCT03099187|141445842|SUPERIORITY||Cox Proportional Hazard|0.84||||0.366|TWO_SIDED|95.0|0.56|1.24|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.||Primary Analysis in 2019||1.24|0.56|0.3660
70970116|NCT03099187|141445842|SUPERIORITY||Cox Proportional Hazard|0.85||||0.4173|TWO_SIDED|95.0|0.57|1.26|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.||Final Analysis in 2020||1.26|0.57|0.4173
70970117|NCT03099187|141445843|SUPERIORITY||Cox Proportional Hazard|0.79||||0.2726|TWO_SIDED|95.0|0.52|1.2|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.||Primary Analysis in 2019||1.20|0.52|0.2726
70970118|NCT03099187|141445843|SUPERIORITY||Cox Proportional Hazard|0.82||||0.3386|TWO_SIDED|95.0|0.54|1.24|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.||Final Analysis in 2020||1.24|0.54|0.3386
70970119|NCT03099187|141445844|SUPERIORITY||Cox Proportional Hazard|1.01||||0.9969|TWO_SIDED|95.0|0.06|16.08|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.||||16.08|0.06|0.9969
70970120|NCT03099187|141445845|SUPERIORITY|||||||0.3231|||||||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.||||||0.3231
70970121|NCT00894556|141445883|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Generalized Linear Mixed Model (GLIMMIX)|An unstructured covariance matrix was used to model the correlation among repeated measurements within patient.||||||<0.001
70970122|NCT00894556|141445884|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Generalized Linear Mixed Model (GLIMMIX)|An unstructured covariance matrix was used to model the correlation among repeated measurements within patient.||||||<0.001
70970123|NCT04294901|141445937|SUPERIORITY||Odds Ratio (OR)|1.21||||0.008|TWO_SIDED|95.0|1.05|1.38|||Mixed Models Analysis|Binary mixed effect model with patients nested in providers nested in facilities||It is pre-specified in the Study Protocol and Statistical Analysis Plan to assess all medication groups combined within the Intervention and Control Arms/Groups.||1.38|1.05|0.008
70970124|NCT02831673|141446032|NON_INFERIORITY|Treatment with DTG+ 3TC was to be declared non-inferior to treatment with DTG+TDF/FTC if the lower end of a two-sided 95% confidence interval for the difference between the two groups in response rates at Week 48 greater than -10%.|Adjusted difference in proportion|-2.6|||||TWO_SIDED|95.0|-6.7|1.5|||||Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<=versus \[vs.\]\>100,000 c/mL) and cluster of differentiation 4+ (CD4+) cell count (\<= vs. \>200 cells per cubic millimeter).|||1.5|-6.7|
70970125|NCT02831673|141446033|OTHER||Adjusted difference in proportion|-0.4|||||TWO_SIDED|95.0|-4.2|3.4|||||Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<=vs.\>100,000 c/mL) and CD4+ cell count (\<= vs. \>200 cells per cubic millimeter).|||3.4|-4.2|
70970126|NCT02831673|141446034|OTHER||Adjusted difference in proportion|-4.9|||||TWO_SIDED|95.0|-9.8|0.0|||||Week 96. Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<= vs. \>100,000 c/mL) and CD4+ cell count (\<= vs. \>200 cells/mm\^3).|||0.0|-9.8|
70970127|NCT02831673|141446035|OTHER||Adjusted difference in proportion|-3.6|||||TWO_SIDED|95.0|-9.4|2.1|||||Week 144. Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<= vs. \>100,000 c/mL) and CD4+ cell count (\<= vs. \>200 cells/mm\^3).|||2.1|-9.4|
70970128|NCT02831673|141446036|OTHER||Hazard Ratio (HR)|1.0||||0.658|TWO_SIDED|95.0|0.86|1.16||The generalized Wilcoxon procedure was used to estimate a p-value for detecting a difference in cumulative incidence curves between treatment groups.|Generalized Wilcoxon procedure||Hazard ratios were estimated using the Cox proportional hazard regression model.|||1.16|0.86|0.658
70970129|NCT02831673|141446040|OTHER||Mean Difference (Net)|17.1||||0.206|TWO_SIDED|95.0|-9.4|43.6|||Mixed Model Repeated Measures (MMRM)||Week 24. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||43.6|-9.4|0.206
71092002|NCT02030600|141690591|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of IDeg against IGlar was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.40%.|Treatment contrast|0.09|||||TWO_SIDED|95.0|-0.04|0.23||||||"Change from baseline in HbA1c at week 32 (treatment period 1). Before the primary endpoint was tested, the secondary supportive efficacy endpoint Change from baseline in HbA1c after 32 weeks of treatment was tested for non-inferiority as prerequisite for testing the primary endpoint. Analysis was performed using a mixed model for repeated measurement (MMRM) with treatment, sex, antidiabetic therapy at screening, visit and dosing time as fixed effects, and age and baseline HbA1c as covariates."||0.23|-0.04|
70970130|NCT02831673|141446040|OTHER||Mean Difference (Net)|4.6||||0.754|TWO_SIDED|95.0|-23.9|33.0|||Mixed Model Repeated Measures (MMRM)||Week 48. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||33.0|-23.9|0.754
70970131|NCT02831673|141446041|OTHER||Mean Difference (Net)|10.8||||0.5|TWO_SIDED|95.0|-20.7|42.4|||Mixed Model Repeated Measures (MMRM)||Week 96. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||42.4|-20.7|0.500
70970132|NCT02831673|141446042|OTHER||Mean Difference (Net)|-1.4||||0.934|TWO_SIDED|95.0|-34.2|31.5|||Mixed Model Repeated Measures (MMRM)||Week 144.Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||31.5|-34.2|0.934
70970133|NCT02831673|141446053|OTHER||Mean Difference (Net)|-0.02||||0.025|TWO_SIDED|95.0|-0.04|0.0|||Mixed Model Repeated Measures||Serum Cystatin C, Week 24|||0.00|-0.04|0.025
70970134|NCT02831673|141446053|OTHER||Mean Difference (Net)|-0.03||||0.001|TWO_SIDED|95.0|-0.05|-0.01|||Mixed Model Repeated Measures||Serum Cystatin C, Week 48|||-0.01|-0.05|0.001
70970135|NCT02831673|141446053|OTHER||Mean Difference (Net)|-0.3||||0.683|TWO_SIDED|95.0|-1.6|1.0|||Mixed Model Repeated Measures||Serum RBP, Week 24|||1.0|-1.6|0.683
70970136|NCT02831673|141446053|OTHER||Mean Difference (Net)|-0.1||||0.93|TWO_SIDED|95.0|-1.4|1.2|||Mixed Model Repeated Measures||Serum RBP, Week 48|||1.2|-1.4|0.930
70970137|NCT02831673|141446054|OTHER||Mean Difference (Net)|-0.02||||0.009|TWO_SIDED|95.0|-0.04|-0.01|||Mixed Model Repeated Measures||Week 96. Serum Cystatin C.|||-0.01|-0.04|0.009
70970138|NCT02831673|141446055|OTHER||Mean Difference (Net)|-0.01||||0.108|TWO_SIDED|95.0|-0.03|0.0|||Mixed Model Repeated Measures||Week 144. Serum Cystatin C.|||-0.00|-0.03|0.108
70970139|NCT02831673|141446058|OTHER||Mean Difference (Net)|2.2||||0.011|TWO_SIDED|95.0|0.5|4.0|||Mixed Model Repeated Measures||GFR-cystatin C adjusted, Week 24|||4.0|0.5|0.011
70970140|NCT02831673|141446058|OTHER||Mean Difference (Net)|2.8|||<|0.001|TWO_SIDED|95.0|1.2|4.5|||Mixed Model Repeated Measures||GFR-cystatin C adjusted, Week 48|||4.5|1.2|<0.001
70970141|NCT02831673|141446058|OTHER||Mean Difference (Net)|3.2|||<|0.001|TWO_SIDED|95.0|1.6|4.8|||Mixed Model Repeated Measures||GFR-creatinine adjusted, Week 24|||4.8|1.6|<0.001
70970142|NCT02831673|141446058|OTHER||Mean Difference (Net)|3.5|||<|0.001|TWO_SIDED|95.0|2.0|5.1|||Mixed Model Repeated Measures||GFR- creatinine adjusted, Week 48|||5.1|2.0|<0.001
70970143|NCT02831673|141446061|OTHER||Mean Difference (Net)|-3.19|||<|0.001|TWO_SIDED|95.0|-4.62|-1.75|||Mixed Model Repeated Measures||Week 24|||-1.75|-4.62|<0.001
70970144|NCT02831673|141446061|OTHER||Mean Difference (Net)|-3.22|||<|0.001|TWO_SIDED|95.0|-4.54|-1.91|||Mixed Model Repeated Measures||Week 48|||-1.91|-4.54|<0.001
70970145|NCT02831673|141446062|OTHER||Mean Difference (Net)|-3.34|||<|0.001|TWO_SIDED|95.0|-4.96|-1.72|||Mixed Model Repeated Measures||Week 96. Serum or Plasma creatinine|||-1.72|-4.96|<0.001
70970146|NCT02831673|141446063|OTHER||Mean Difference (Net)|-2.98|||<|0.001|TWO_SIDED|95.0|-4.57|-1.4|||Mixed Model Repeated Measures||Week 144. Serum or Plasma creatinine|||-1.40|-4.57|<0.001
70970147|NCT02831673|141446064|OTHER||Ratio of geometric means|0.915|||<|0.001|TWO_SIDED|95.0|0.887|0.943|||Mixed Model Repeated Measures||Week 24. Serum B2M|||0.943|0.887|<0.001
70970148|NCT02831673|141446064|OTHER||Ratio of geometric means|0.904|||<|0.001|TWO_SIDED|95.0|0.88|0.929|||Mixed Model Repeated Measures||Week 48. Serum B2M|||0.929|0.880|<0.001
70970149|NCT02831673|141446064|OTHER||Ratio of geometric means|0.656||||0.005|TWO_SIDED|95.0|0.491|0.877|||Mixed Model Repeated Measures||Week 24. Urine B2M|||0.877|0.491|0.005
70970150|NCT02831673|141446064|OTHER||Ratio of geometric means|0.672|||<|0.001|TWO_SIDED|95.0|0.551|0.821|||Mixed Model Repeated Measures||Week 48. Urine B2M|||0.821|0.551|<0.001
70909330|NCT02886728|141307199|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-4.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-4.0|<0.001
70970151|NCT02831673|141446064|OTHER||Ratio of geometric means|0.965||||0.575|TWO_SIDED|95.0|0.853|1.092|||Mixed Model Repeated Measures||Week 24. Urine Albumin/Creatinine|||1.092|0.853|0.575
70970152|NCT02831673|141446064|OTHER||Ratio of geometric means|0.891||||0.051|TWO_SIDED|95.0|0.793|1.001|||Mixed Model Repeated Measures||Week 48. Urine Albumin/Creatinine|||1.001|0.793|0.051
70970153|NCT02831673|141446064|OTHER||Ratio of geometric means|0.64|||<|0.001|TWO_SIDED|95.0|0.493|0.831|||Mixed Model Repeated Measures||Week 24. Urine B2M/Urine Creatinine|||0.831|0.493|<0.001
70970154|NCT02831673|141446064|OTHER||Ratio of geometric means|0.695|||<|0.001|TWO_SIDED|95.0|0.576|0.839|||Mixed Model Repeated Measures||Week 48. Urine B2M/Urine Creatinine|||0.839|0.576|<0.001
70970155|NCT02831673|141446064|OTHER||Ratio of geometric means|1.102||||0.099|TWO_SIDED|95.0|0.982|1.237|||Mixed Model Repeated Measures||Week 24. Urine Phosphate|||1.237|0.982|0.099
70970156|NCT02831673|141446064|OTHER||Ratio of geometric means|0.987||||0.816|TWO_SIDED|95.0|0.886|1.1|||Mixed Model Repeated Measures||Week 48. Urine Phosphate|||1.100|0.886|0.816
70970157|NCT02831673|141446064|OTHER||Ratio of geometric means|0.836|||<|0.001|TWO_SIDED|95.0|0.774|0.904|||Mixed Model Repeated Measures||Week 24. Urine Protein/Creatinine|||0.904|0.774|<0.001
70970158|NCT02831673|141446064|OTHER||Ratio of geometric means|0.829|||<|0.001|TWO_SIDED|95.0|0.773|0.888|||Mixed Model Repeated Measures||Week 48. Urine Protein/Creatinine|||0.888|0.773|<0.001
70970159|NCT02831673|141446064|OTHER||Ratio of geometric means|0.871||||0.087|TWO_SIDED|95.0|0.743|1.02|||Mixed Model Repeated Measures||Week 24. Urine RBP 4|||1.020|0.743|0.087
70970160|NCT02831673|141446064|OTHER||Ratio of geometric means|0.748|||<|0.001|TWO_SIDED|95.0|0.644|0.87|||Mixed Model Repeated Measures||Week 48. Urine RBP 4|||0.870|0.644|<0.001
70970161|NCT02831673|141446064|OTHER||Ratio of geometric means|0.828||||0.005|TWO_SIDED|95.0|0.727|0.944|||Mixed Model Repeated Measures||Week 24. Urine RBP 4/Urine Creatinine|||0.944|0.727|0.005
70970162|NCT02831673|141446064|OTHER||Ratio of geometric means|0.765|||<|0.001|TWO_SIDED|95.0|0.677|0.864|||Mixed Model Repeated Measures||Week 48. Urine RBP 4/Urine Creatinine|||0.864|0.677|<0.001
70970163|NCT02831673|141446065|OTHER||Ratio of geometric means|0.839||||0.006|TWO_SIDED|95.0|0.742|0.95|||Mixed Model Repeated Measures||Week 96. Urine Albumin/Creatinine.|||0.950|0.742|0.006
70970164|NCT02831673|141446065|OTHER||Ratio of geometric means|0.551|||<|0.001|TWO_SIDED|95.0|0.445|0.682|||Mixed Model Repeated Measures||Week 96. Urine B2M/Urine Creatinine.|||0.682|0.445|<0.001
70970165|NCT02831673|141446065|OTHER||Ratio of geometric means|1.045||||0.467|TWO_SIDED|95.0|0.928|1.175|||Mixed Model Repeated Measures||Week 96. Urine Phosphate.|||1.175|0.928|0.467
70970166|NCT02831673|141446065|OTHER||Ratio of geometric means|0.824|||<|0.001|TWO_SIDED|95.0|0.764|0.889|||Mixed Model Repeated Measures||Week 96. Urine Protein/Creatinine.|||0.889|0.764|<0.001
70970167|NCT02831673|141446065|OTHER||Ratio of geometric means|0.74|||<|0.001|TWO_SIDED|95.0|0.651|0.84|||Mixed Model Repeated Measures||Week 96. Urine RBP 4/Urine Creatinine|||0.840|0.651|<0.001
70970168|NCT02831673|141446066|OTHER||Ratio of geometric means|0.916||||0.205|TWO_SIDED|95.0|0.799|1.05|||Mixed Model Repeated Measures||Week 144. Urine Albumin/Creatinine.|||1.050|0.799|0.205
70970169|NCT02831673|141446066|OTHER||Ratio of geometric means|0.495|||<|0.001|TWO_SIDED|95.0|0.406|0.603|||Mixed Model Repeated Measures||Week 144. Urine B2M/Urine Creatinine.|||0.603|0.406|<0.001
70970170|NCT02831673|141446066|OTHER||Ratio of geometric means|1.089||||0.16|TWO_SIDED|95.0|0.967|1.226|||Mixed Model Repeated Measures||Week 144. Urine Phosphate.|||1.226|0.967|0.160
70970171|NCT02831673|141446066|OTHER||Ratio of geometric means|0.817|||<|0.001|TWO_SIDED|95.0|0.753|0.885|||Mixed Model Repeated Measures||Week 144. Urine Protein/Creatinine.|||0.885|0.753|<0.001
70970172|NCT02831673|141446066|OTHER||Ratio of geometric means|0.679|||<|0.001|TWO_SIDED|95.0|0.607|0.76|||Mixed Model Repeated Measures||Week 144. Urine RBP 4/Urine Creatinine|||0.760|0.607|<0.001
70970173|NCT02831673|141446067|OTHER||Mean Difference (Net)|-2.23|||<|0.001|TWO_SIDED|95.0|-2.75|-1.7|||Mixed Model Repeated Measures||Week 24. Bone ALP|||-1.70|-2.75|<0.001
70970174|NCT02831673|141446067|OTHER||Mean Difference (Net)|-2.58|||<|0.001|TWO_SIDED|95.0|-3.19|-1.98|||Mixed Model Repeated Measures||Week 48. Bone ALP|||-1.98|-3.19|<0.001
70970175|NCT02831673|141446067|OTHER||Mean Difference (Net)|-4.19|||<|0.001|TWO_SIDED|95.0|-5.15|-3.23|||Mixed Model Repeated Measures||Week 28. Serum Osteocalcin|||-3.23|-5.15|<0.001
70970176|NCT02831673|141446067|OTHER||Mean Difference (Net)|-5.23|||<|0.001|TWO_SIDED|95.0|-6.22|-4.23|||Mixed Model Repeated Measures||Week 48. Serum Osteocalcin|||-4.23|-6.22|<0.001
70970177|NCT02831673|141446067|OTHER||Mean Difference (Net)|-13.8|||<|0.001|TWO_SIDED|95.0|-16.5|-11.1|||Mixed Model Repeated Measures||Week 24. Serum PINP|||-11.1|-16.5|<0.001
70970178|NCT02831673|141446067|OTHER||Mean Difference (Net)|-12.6|||<|0.001|TWO_SIDED|95.0|-15.0|-10.3|||Mixed Model Repeated Measures||Week 48. Serum PINP|||-10.3|-15.0|<0.001
70970179|NCT02831673|141446067|OTHER||Mean Difference (Net)|-0.1628|||<|0.001|TWO_SIDED|95.0|-0.2015|-0.1241|||Mixed Model Repeated Measures||Week 24. CTX-1|||-0.1241|-0.2015|<0.001
70970180|NCT02831673|141446067|OTHER||Mean Difference (Net)|-0.2015|||<|0.001|TWO_SIDED|95.0|-0.246|-0.1569|||Mixed Model Repeated Measures||Week 48. CTX-1|||-0.1569|-0.2460|<0.001
70970181|NCT02831673|141446068|OTHER||Mean Difference (Net)|-2.06|||<|0.001|TWO_SIDED|95.0|-2.63|-1.5|||Mixed Model Repeated Measures||Week 96, Bone ALP|||-1.50|-2.63|<0.001
70970182|NCT02831673|141446068|OTHER||Mean Difference (Net)|-4.17|||<|0.001|TWO_SIDED|95.0|-5.2|-3.14|||Mixed Model Repeated Measures||Week 96, Serum Osteocalcin|||-3.14|-5.20|<0.001
71153643|NCT00486291|141799797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.16||0.0007|TWO_SIDED|95.0|-0.9|-0.2|||ANCOVA|||It is anticipated that the pooled standard deviation (SD) of the change from baseline in HbA1c will be between 1.0 and 1.5. With 90 subjects per treatment group the study will have 90% power (two-sided alpha=0.05) to detect a mean difference between groups of 0.486 for SD=1.0, and a mean difference between groups of 0.729 for SD=1.5.||-0.2|-0.9|0.0007
71153644|NCT00486291|141799798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-8.1|-4.9|||ANCOVA|||||-4.9|-8.1|<0.0001
70970183|NCT02831673|141446068|OTHER||Mean Difference (Net)|-13.3|||<|0.001|TWO_SIDED|95.0|-17.6|-8.9|||Mixed Model Repeated Measures||Week 96, Serum PINP|||-8.9|-17.6|<0.001
70970184|NCT02831673|141446068|OTHER||Mean Difference (Net)|-0.1592|||<|0.001|TWO_SIDED|95.0|-0.208|-0.1104|||Mixed Model Repeated Measures||Week 96, CTX-1|||-0.1104|-0.2080|<0.001
70970185|NCT02831673|141446069|OTHER||Mean Difference (Net)|-1.68|||<|0.001|TWO_SIDED|95.0|-2.23|-1.14|||Mixed Model Repeated Measures||Week 144, Bone ALP|||-1.14|-2.23|<0.001
70970186|NCT02831673|141446069|OTHER||Mean Difference (Net)|-2.91|||<|0.001|TWO_SIDED|95.0|-4.0|-1.83|||Mixed Model Repeated Measures||Week 144, Serum Osteocalcin|||-1.83|-4.00|<0.001
70970187|NCT02831673|141446069|OTHER||Mean Difference (Net)|-9.2|||<|0.001|TWO_SIDED|95.0|-12.3|-6.2|||Mixed Model Repeated Measures||Week 144, Serum PINP|||-6.2|-12.3|<0.001
70970188|NCT02831673|141446069|OTHER||Mean Difference (Net)|-0.1414|||<|0.001|TWO_SIDED|95.0|-0.1771|-0.1056|||Mixed Model Repeated Measures||Week 144, CTX-1|||-0.1056|-0.1771|<0.001
70970189|NCT02831673|141446070|OTHER||Mean Difference (Net)|-6.5|||<|0.001|TWO_SIDED|95.0|-9.9|-3.0|||Mixed Model Repeated Measures||Week 24|||-3.0|-9.9|<0.001
70970190|NCT02831673|141446070|OTHER||Mean Difference (Net)|-6.2|||<|0.001|TWO_SIDED|95.0|-9.0|-3.4|||Mixed Model Repeated Measures||Week 48|||-3.4|-9.0|<0.001
70970191|NCT02831673|141446071|OTHER||Mean Difference (Net)|-2.9||||0.048|TWO_SIDED|95.0|-5.8|0.0|||Mixed Model Repeated Measures||Week 96|||0.0|-5.8|0.048
70970192|NCT02831673|141446072|OTHER||Mean Difference (Net)|-4.9||||0.004|TWO_SIDED|95.0|-8.3|-1.6|||Mixed Model Repeated Measures||Week 144|||-1.6|-8.3|0.004
70970193|NCT02831673|141446079|OTHER||Difference in percentage|2.0||||0.157|TWO_SIDED|95.0|-0.6|4.6||Fisher's exact p-value.|Fisher Exact||Week 24|||4.6|-0.6|0.157
70970194|NCT02831673|141446079|OTHER||Difference in percentage|1.3||||0.414|TWO_SIDED|95.0|-1.7|4.2||Fisher's exact p-value.|Fisher Exact||Week 48|||4.2|-1.7|0.414
70970195|NCT02831673|141446080|OTHER||Difference in percentage|1.0||||0.562|TWO_SIDED|95.0|-2.1|4.1||Fisher's exact p-value.|Fisher Exact||Week 96|||4.1|-2.1|0.562
70970196|NCT02831673|141446081|OTHER||Difference in percentage|0.9||||0.587|TWO_SIDED|95.0|-2.4|4.3||Fisher's exact p-value.|Fisher Exact||Week 144|||4.3|-2.4|0.587
70970197|NCT02831673|141446086|OTHER||Mean Difference (Net)|19.8|||||TWO_SIDED|95.0|-10.23|49.83|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and HIV-1 RNA interaction.|||49.83|-10.23|
70970198|NCT02831673|141446086|OTHER||Mean Difference (Net)|0.67|||||TWO_SIDED|95.0|-57.07|58.4|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and HIV-1 RNA interaction.|||58.40|-57.07|
70970199|NCT02831673|141446086|OTHER||Mean Difference (Net)|36.84|||||TWO_SIDED|95.0|-55.94|129.63|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||129.63|-55.94|
70970200|NCT02831673|141446086|OTHER||Mean Difference (Net)|14.37|||||TWO_SIDED|95.0|-13.38|42.12|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||42.12|-13.38|
70970201|NCT02831673|141446086|OTHER||Mean Difference (Net)|25.14|||||TWO_SIDED|95.0|-9.56|59.85|||||Age\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||59.85|-9.56|
70970202|NCT02831673|141446086|OTHER||Mean Difference (Net)|-7.82|||||TWO_SIDED|95.0|-55.98|40.34|||||Age 35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||40.34|-55.98|
70970203|NCT02831673|141446086|OTHER||Mean Difference (Net)|29.45|||||TWO_SIDED|95.0|-55.47|114.38|||||Age\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||114.38|-55.47|
70970204|NCT02831673|141446086|OTHER||Mean Difference (Net)|17.67|||||TWO_SIDED|95.0|-49.89|85.23|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||85.23|-49.89|
70970205|NCT02831673|141446086|OTHER||Mean Difference (Net)|15.16|||||TWO_SIDED|95.0|-13.9|44.21|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||44.21|-13.90|
70970206|NCT02831673|141446086|OTHER||Mean Difference (Net)|22.51|||||TWO_SIDED|95.0|-9.52|54.54|||||Race group white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||54.54|-9.52|
70970207|NCT02831673|141446086|OTHER||Mean Difference (Net)|-26.67|||||TWO_SIDED|95.0|-110.64|57.3|||||Race group African Am/African H.. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||57.30|-110.64|
70970208|NCT02831673|141446086|OTHER||Mean Difference (Net)|4.44||||||95.0|-76.18|85.06|||||Race group Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||85.06|-76.18|
70970209|NCT02831673|141446086|OTHER||Mean Difference (Net)|24.96|||||TWO_SIDED|95.0|-60.68|110.59|||||Race group Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||110.59|-60.68|
70970210|NCT02831673|141446087|OTHER||Mean Difference (Net)|7.6|||||TWO_SIDED|95.0|-24.6|39.8|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count and treatment and HIV-1 RNA interaction.|||39.8|-24.6|
70970211|NCT02831673|141446087|OTHER||Mean Difference (Net)|3.0|||||TWO_SIDED|95.0|-59.8|65.9|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count and treatment and HIV-1 RNA interaction.|||65.9|-59.8|
70970212|NCT02831673|141446087|OTHER||Mean Difference (Net)|22.6|||||TWO_SIDED|95.0|-78.3|123.5|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||123.5|-78.3|
70970213|NCT02831673|141446087|OTHER||Mean Difference (Net)|5.2|||||TWO_SIDED|95.0|-24.7|35.1|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||35.1|-24.7|
70970214|NCT02831673|141446087|OTHER||Mean Difference (Net)|8.4|||||TWO_SIDED|95.0|-29.1|45.9|||||Age\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||45.9|-29.1|
70970215|NCT02831673|141446087|OTHER||Mean Difference (Net)|-2.5|||||TWO_SIDED|95.0|-53.9|48.9|||||Age 35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||48.9|-53.9|
70970216|NCT02831673|141446087|OTHER||Mean Difference (Net)|17.7|||||TWO_SIDED|95.0|-74.6|110.1|||||Age\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||110.1|-74.6|
70970217|NCT02831673|141446087|OTHER||Mean Difference (Net)|10.4|||||TWO_SIDED|95.0|-62.3|83.1|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||83.1|-62.3|
70970218|NCT02831673|141446087|OTHER||Mean Difference (Net)|5.6|||||TWO_SIDED|95.0|-25.6|36.9|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||36.9|-25.6|
70970219|NCT02831673|141446087|OTHER||Mean Difference (Net)|6.3|||||TWO_SIDED|95.0|-28.2|40.9|||||Race group white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||40.9|-28.2|
70970220|NCT02831673|141446087|OTHER||Mean Difference (Net)|-30.2|||||TWO_SIDED|95.0|-122.7|62.4|||||Race group African Am/African H.. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||62.4|-122.7|
70970221|NCT02831673|141446087|OTHER||Mean Difference (Net)|49.2|||||TWO_SIDED|95.0|-36.3|134.7|||||Race group Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||134.7|-36.3|
70970222|NCT02831673|141446087|OTHER||Mean Difference (Net)|-2.5|||||TWO_SIDED|95.0|-94.7|89.7|||||Race group Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||89.7|-94.7|
70970223|NCT02831673|141446088|OTHER||Mean Difference (Net)|1.9|||||TWO_SIDED|95.0|-34.5|38.2|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and relevant Baseline plasma HIV-1 RNA interaction.|||38.2|-34.5|
70970224|NCT02831673|141446088|OTHER||Mean Difference (Net)|40.1|||||TWO_SIDED|95.0|-31.2|111.5|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and HIV-1 RNA interaction.|||111.5|-31.2|
70970225|NCT02831673|141446088|OTHER||Mean Difference (Net)|-3.9|||||TWO_SIDED|95.0|-122.3|114.5|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||114.5|-122.3|
70970226|NCT02831673|141446088|OTHER||Mean Difference (Net)|10.8|||||TWO_SIDED|95.0|-22.9|44.5|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||44.5|-22.9|
70970227|NCT02831673|141446088|OTHER||Mean Difference (Net)|7.3|||||TWO_SIDED|95.0|-35.0|49.6|||||Age Group,\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||49.6|-35.0|
70970228|NCT02831673|141446088|OTHER||Mean Difference (Net)|-2.5|||||TWO_SIDED|95.0|-60.7|55.7|||||Age Group,35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||55.7|-60.7|
70970229|NCT02831673|141446088|OTHER||Mean Difference (Net)|41.6|||||TWO_SIDED|95.0|-61.2|144.5|||||Age\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||144.5|-61.2|
70970230|NCT02831673|141446088|OTHER||Mean Difference (Net)|18.8|||||TWO_SIDED|95.0|-64.2|101.8|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||101.8|-64.2|
70970231|NCT02831673|141446088|OTHER||Mean Difference (Net)|7.8|||||TWO_SIDED|95.0|-27.4|43.1|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||43.1|-27.4|
70970232|NCT02831673|141446088|OTHER||Mean Difference (Net)|15.2|||||TWO_SIDED|95.0|-23.6|54.0|||||Race group-white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||54.0|-23.6|
70970233|NCT02831673|141446088|OTHER||Mean Difference (Net)|-1.7|||||TWO_SIDED|95.0|-106.3|103.0|||||Race group-African Am/African H. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||103.0|-106.3|
70970234|NCT02831673|141446088|OTHER||Median Difference (Net)|-32.6|||||TWO_SIDED|95.0|-132.2|66.9|||||Race group-Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||66.9|-132.2|
70970235|NCT02831673|141446088|OTHER||Mean Difference (Net)|26.1|||||TWO_SIDED|95.0|-77.3|129.5|||||Race group-Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||129.5|-77.3|
70970236|NCT02831673|141446089|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-39.2|38.3|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and relevant Baseline plasma HIV-1 RNA interaction.|||38.3|-39.2|
70970237|NCT02831673|141446089|OTHER||Mean Difference (Net)|4.7|||||TWO_SIDED|95.0|-69.4|78.8|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and Baseline plasma HIV-1 RNA interaction.|||78.8|-69.4|
70970238|NCT02831673|141446089|OTHER||Mean Difference (Net)|17.4|||||TWO_SIDED|95.0|-111.1|145.8|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||145.8|-111.1|
70970239|NCT02831673|141446089|OTHER||Mean Difference (Net)|-1.5|||||TWO_SIDED|95.0|-37.2|34.1|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||34.1|-37.2|
70970240|NCT02831673|141446089|OTHER||Mean Difference (Net)|-18.0|||||TWO_SIDED|95.0|-63.2|27.1|||||Age Group,\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||27.1|-63.2|
70970241|NCT02831673|141446089|OTHER||Mean Difference (Net)|3.5|||||TWO_SIDED|95.0|-57.0|64.0|||||Age Group,35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||64.0|-57.0|
70970242|NCT02831673|141446089|OTHER||Mean Difference (Net)|95.2|||||TWO_SIDED|95.0|-14.8|205.2|||||Age Group,\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||205.2|-14.8|
70970243|NCT02831673|141446089|OTHER||Mean Difference (Net)|24.9|||||TWO_SIDED|95.0|-62.5|112.3|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||112.3|-62.5|
70970244|NCT02831673|141446089|OTHER||Mean Difference (Net)|-4.2|||||TWO_SIDED|95.0|-41.5|33.1|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||33.1|-41.5|
70970245|NCT02831673|141446089|OTHER||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-40.6|41.1|||||Race group-white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||41.1|-40.6|
70970246|NCT02831673|141446089|OTHER||Mean Difference (Net)|-51.3|||||TWO_SIDED|95.0|-163.6|60.9|||||Race group-African Am/African H. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||60.9|-163.6|
70970247|NCT02831673|141446089|OTHER||Median Difference (Net)|-20.1|||||TWO_SIDED|95.0|-125.3|85.0|||||Race group-Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction|||85.0|-125.3|
70970248|NCT02831673|141446089|OTHER||Mean Difference (Net)|66.2|||||TWO_SIDED|95.0|-43.7|176.2|||||Race group-Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||176.2|-43.7|
70970249|NCT02831673|141446090|OTHER||Mean Difference (Net)|0.0052||||0.302|TWO_SIDED|95.0|-0.0047|0.0152|||MMRM||Week 4. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit with visit as the repeated factor|||0.0152|-0.0047|0.302
70970250|NCT02831673|141446090|OTHER||Mean Difference (Net)|-0.0038||||0.45|TWO_SIDED|95.0|-0.0136|0.006|||MMRM||Week24. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit with visit as the repeated factor|||0.0060|-0.0136|0.450
70970251|NCT02831673|141446090|OTHER||Mean Difference (Net)|0.0004||||0.934|TWO_SIDED|95.0|-0.0098|0.0106|||MMRM||Week48. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit with visit as the repeated factor|||0.0106|-0.0098|0.934
70970252|NCT02831673|141446091|OTHER||Mean Difference (Net)|-0.0012||||0.842|TWO_SIDED|95.0|-0.0132|0.0107|||MMRM||Week 96. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0107|-0.0132|0.842
70970253|NCT02831673|141446092|OTHER||Mean Difference (Net)|0.0008||||0.879|TWO_SIDED|95.0|-0.0097|0.0113|||MMRM||Week 144. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0113|-0.0097|0.879
70970254|NCT02831673|141446093|OTHER||Mean Difference (Net)|1.1||||0.137|TWO_SIDED|95.0|-0.3|2.4|||MMRM||Week 4. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA (factor),Baseline CD4+ cell count (factor), Baseline EQ-5D thermometer, treatment\*visit and Baseline EQ-5D thermometer\*visit with visit as the repeated factor|||2.4|-0.3|0.137
70970255|NCT02831673|141446093|OTHER||Mean Difference (Net)|0.6||||0.458|TWO_SIDED|95.0|-0.9|2.0|||MMRM||Week24. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA (factor),Baseline CD4+ cell count (factor), Baseline EQ-5D thermometer, treatment\*visit and Baseline EQ-5D thermometer\*visit with visit as the repeated factor|||2.0|-0.9|0.458
70970256|NCT02831673|141446093|OTHER||Mean Difference (Net)|1.5||||0.031|TWO_SIDED|95.0|0.1|2.8|||MMRM||Week48. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA (factor),Baseline CD4+ cell count (factor), Baseline EQ-5D thermometer, treatment\*visit and Baseline EQ-5D thermometer\*visit with visit as the repeated factor|||2.8|0.1|0.031
70970257|NCT02831673|141446094|OTHER||Mean Difference (Net)|1.7||||0.027|TWO_SIDED|95.0|0.2|3.2|||MMRM||Week 96. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||3.2|0.2|0.027
70970258|NCT02831673|141446095|OTHER||Mean Difference (Net)|2.3||||0.001|TWO_SIDED|95.0|0.9|3.6|||MMRM||Week 144. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||3.6|0.9|0.001
70970259|NCT03615183|141446103|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-1.36|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8527 and placebo ≤ -1.0 copies/mL was 99.72%.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK- 8527 and placebo is at least 1.0 log10 copies/mL.||||
70970260|NCT03615183|141446103|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a LDA model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-1.63|||||||||||||PP of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8527 and placebo ≤ -1.0 copies/mL was 99.86%.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK- 8527 and placebo is at least 1.0 log10 copies/mL.||||
70970261|NCT03615183|141446103|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a LDA model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-0.92|||||||||||||PP of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8527 and placebo ≤ -1.0 copies/mL was 9.42%.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK- 8527 and placebo is at least 1.0 log10 copies/mL.||||
70970262|NCT01977781|141446120|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Wilcoxon (Mann-Whitney)|||Only the statistical analysis results for burning sensation at 10 weeks are reported below as they where the only tolerability results found to be significantly different between the two arms. All other tolerability measures were found to be the same between the two groups.||||0.0019
70970263|NCT00847912|141446155|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93|||||||Log Rank|||||||0.93
70909331|NCT02886728|141307199|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-2.0|<0.001
70970264|NCT00847912|141446156|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.93|TWO_SIDED|95.0|0.82|1.24|||Regression, Cox|||||1.24|0.82|0.93
70970265|NCT01074190|141446162|SUPERIORITY|||||||0.34|||||||Chi-squared|||||||.34
70970266|NCT01074190|141446163|SUPERIORITY|||||||0.1|||||||Chi-squared|||||||.1
70970267|NCT01074190|141446164|SUPERIORITY|||||||0.1|||||||Chi-squared|||A sample size of 315 achieves 80% power to detect a difference among groups using a 2 degrees of freedom Chi-Square Test with a significance level (alpha) of 0.05.||||.1
70970268|NCT03882970|141446170|NON_INFERIORITY|The study was powered for superiority in HbA1c. The sample size provided \>99% power to show noninferiority assuming a 0.3% NI boundary, 0.35% greater mean reduction in tirzepatide doses compared to insulin degludec, 1:1:1:1 randomization, a common SD of 1.1%, 1 sided significance level of 0.0125, and a dropout rate of 28%.|LS Mean Difference|-0.86|||<|0.001|TWO_SIDED|95.0|-1.0|-0.72|||Mixed Models Analysis|||||-0.72|-1.00|<0.001
70970269|NCT03882970|141446170|NON_INFERIORITY|The study was powered for superiority in HbA1c. The sample size provided \>99% power to show noninferiority assuming a 0.3% NI boundary, 0.35% greater mean reduction in tirzepatide doses compared to insulin degludec, 1:1:1:1 randomization, a common SD of 1.1%, 1 sided significance level of 0.0125, and a dropout rate of 28%.|LS Mean Difference|-1.04|||<|0.001|TWO_SIDED|95.0|-1.17|-0.9|||Mixed Models Analysis|||||-0.90|-1.17|<0.001
70970270|NCT03882970|141446171|NON_INFERIORITY|The study was powered for superiority in HbA1c. The sample size provided \>99% power to show noninferiority assuming a 0.3% NI boundary, 0.35% greater mean reduction in tirzepatide doses compared to insulin degludec, 1:1:1:1 randomization, a common SD of 1.1%, 1 sided significance level of 0.0125, and a dropout rate of 28%.|LS Mean Difference|-0.59|||<|0.001|TWO_SIDED|95.0|-0.73|-0.45|||Mixed Models Analysis|||||-0.45|-0.73|<0.001
70970271|NCT03882970|141446172|SUPERIORITY||LS Mean Difference|-9.8|||<|0.001|TWO_SIDED|95.0|-10.8|-8.8|||Mixed Models Analysis|||||-8.8|-10.8|<0.001
70970272|NCT03882970|141446172|SUPERIORITY||LS Mean Difference|-13.0|||<|0.001|TWO_SIDED|95.0|-14.0|-11.9|||Mixed Models Analysis|||||-11.9|-14.0|<0.001
70970273|NCT03882970|141446172|SUPERIORITY||LS Mean Difference|-15.2|||<|0.001|TWO_SIDED|95.0|-16.2|-14.2|||Mixed Models Analysis|||||-14.2|-16.2|<0.001
70970274|NCT03882970|141446173|SUPERIORITY||LS Mean Difference|7.5||||0.004|TWO_SIDED|95.0|2.4|12.5|||Mixed Models Analysis|||||12.5|2.4|0.004
70970275|NCT03882970|141446173|SUPERIORITY||LS Mean Difference|0.8||||0.751|TWO_SIDED|95.0|-4.3|5.9|||Mixed Models Analysis|||||5.9|-4.3|0.751
70970276|NCT03882970|141446173|SUPERIORITY||LS Mean Difference|-3.6||||0.168|TWO_SIDED|95.0|-8.7|1.5|||Mixed Models Analysis|||||1.5|-8.7|0.168
70970277|NCT03882970|141446174|SUPERIORITY||Odds Ratio (OR)|3.45|||<|0.001|TWO_SIDED|95.0|2.38|5.01|||Regression, Logistic|||||5.01|2.38|<0.001
70970278|NCT03882970|141446174|SUPERIORITY||Odds Ratio (OR)|7.02|||<|0.001|TWO_SIDED|95.0|4.55|10.84|||Regression, Logistic|||||10.84|4.55|<0.001
70970279|NCT03882970|141446174|SUPERIORITY||Odds Ratio (OR)|10.79|||<|0.001|TWO_SIDED|95.0|6.65|17.48|||Regression, Logistic|||||17.48|6.65|<0.001
70970280|NCT03882970|141446176|SUPERIORITY||Odds Ratio (OR)|29.78|||<|0.001|TWO_SIDED|95.0|18.35|48.35|||Regression, Logistic|||||48.35|18.35|<0.001
70970281|NCT03882970|141446176|SUPERIORITY||Odds Ratio (OR)|79.88|||<|0.001|TWO_SIDED|95.0|47.56|134.17|||Regression, Logistic|||||134.17|47.56|<0.001
70970282|NCT03882970|141446176|SUPERIORITY||Odds Ratio (OR)|110.77|||<|0.001|TWO_SIDED|95.0|64.73|189.55|||Regression, Logistic|||||189.55|64.73|<0.001
71153645|NCT01056016|141799828|SUPERIORITY_OR_OTHER||Mean Difference (Net)|32.4|||=|0.003|TWO_SIDED||||||t-test, 2 sided|||The percentage of patients with whom pediatrician in each group utilized each practice behavior at baseline and 6-months was computed. The reported statistical analysis did not account potential clustering due to the small number of practices in this study.||||=.003
70970283|NCT03882970|141446177|SUPERIORITY||LS Mean Difference|-0.26||||0.096|TWO_SIDED|95.0|-0.57|0.05|||ANCOVA|||Hyperglycemia||0.05|-0.57|0.096
70970284|NCT03882970|141446177|SUPERIORITY||LS Mean Difference|-0.25||||0.113|TWO_SIDED|95.0|-0.57|0.06|||ANCOVA|||Hyperglycemia||0.06|-0.57|0.113
70970285|NCT03882970|141446177|SUPERIORITY||LS Mean Difference|-0.47||||0.003|TWO_SIDED|95.0|-0.78|-0.16|||ANCOVA|||Hyperglycemia||-0.16|-0.78|0.003
70970286|NCT03882970|141446177|SUPERIORITY||LS Mean Difference|-0.41||||0.014|TWO_SIDED|95.0|-0.74|-0.08|||ANCOVA|||Hypoglycemia||-0.08|-0.74|0.014
70970287|NCT03882970|141446177|SUPERIORITY||LS Mean Difference|-0.18||||0.28|TWO_SIDED|95.0|-0.51|0.15|||ANCOVA|||Hypoglycemia||0.15|-0.51|0.280
70970288|NCT03882970|141446177|SUPERIORITY||LS Mean Difference|-0.26||||0.129|TWO_SIDED|95.0|-0.59|0.07|||ANCOVA|||Hypoglycemia||0.07|-0.59|0.129
70970289|NCT03882970|141446177|SUPERIORITY||LS Mean Difference|3.01|||<|0.001|TWO_SIDED|95.0|2.26|3.75|||ANCOVA|||Treatment Satisfaction Score||3.75|2.26|<0.001
70970290|NCT03882970|141446177|SUPERIORITY||LS Mean Difference|2.9|||<|0.001|TWO_SIDED|95.0|2.15|3.65|||ANCOVA|||Treatment Satisfaction Score||3.65|2.15|<0.001
70970291|NCT03882970|141446177|SUPERIORITY||LS Mean Difference|2.99|||<|0.001|TWO_SIDED|95.0|2.24|3.74|||ANCOVA|||Treatment Satisfaction Score||3.74|2.24|<0.001
70970292|NCT05284760|141446195|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|Geometric Mean Ratio (GMR)|97.28|||||TWO_SIDED|90.0|87.66|107.96||||||||107.96|87.66|
70970293|NCT05284760|141446195|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|GMR|81.04|||||TWO_SIDED|90.0|73.06|89.89||||||||89.89|73.06|
70970294|NCT05284760|141446195|OTHER||GMR|37.48|||||TWO_SIDED|90.0|31.1|45.17||||||||45.17|31.10|
70970295|NCT05284760|141446195|OTHER||GMR|89.45|||||TWO_SIDED|90.0|74.24|107.79||||||||107.79|74.24|
70970296|NCT05284760|141446196|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|GMR|97.52|||||TWO_SIDED|90.0|92.17|103.17||||||||103.17|92.17|
70970297|NCT05284760|141446196|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|GMR|86.88|||||TWO_SIDED|90.0|82.14|91.89||||||||91.89|82.14|
70970298|NCT05284760|141446196|OTHER||GMR|87.63|||||TWO_SIDED|90.0|75.92|101.15||||||||101.15|75.92|
70970299|NCT05284760|141446196|OTHER||GMR|95.49|||||TWO_SIDED|90.0|82.73|110.22||||||||110.22|82.73|
70970300|NCT05284760|141446197|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|GMR|99.25|||||TWO_SIDED|90.0|92.84|106.1||||||||106.10|92.84|
70970301|NCT05284760|141446197|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|GMR|86.98|||||TWO_SIDED|90.0|81.33|93.03||||||||93.03|81.33|
70970302|NCT05284760|141446197|OTHER||GMR|89.28|||||TWO_SIDED|90.0|78.92|100.99||||||||100.99|78.92|
70970303|NCT05284760|141446197|OTHER||GMR|92.77|||||TWO_SIDED|90.0|81.77|105.25||||||||105.25|81.77|
70970304|NCT00440947|141446211|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be established between the two arms if the lower limit of the 2-sided 95% confidence interval (CI) on the difference in the percentage of participants with HIV-1 RNA \<50 c/mL at Week 84 was -12% or greater.|Risk Difference (RD)|5.4||||0.14|TWO_SIDED|95.0|-1.8|12.5|||Cochran-Mantel-Haenszel|p-value was obtained from Cochran-Mantel-Haenszel stratified by baseline HIV-1 RNA (\<100000/\>=100000)||||12.5|-1.8|0.140
70970305|NCT02017327|141446283|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70970306|NCT02017327|141446283|SUPERIORITY|||||||0.0045|||||||Cochran-Mantel-Haenszel|||||||0.0045
70970307|NCT02813694|141446301|NON_INFERIORITY|non-inferiority margin= 10%|Treatment difference|0.1|||||TWO_SIDED|95.0|-4.4|4.5|||||Difference in percentage of Responders for ECR (Lefamulin - Moxifloxacin). Confidence interval computed using continuity-corrected Z-statistic|||4.5|-4.4|
70970308|NCT02813694|141446302|NON_INFERIORITY|non-inferiority margin = 10%|Treatment difference|-1.6|||||TWO_SIDED|95.0|-6.3|3.1|||||Difference in Percentage of Success for IACR at test of cure visit (Lefamulin - Moxifloxacin). CI computed via Miettinen-Nurminen method, adjusted for prior antibiotic use \[Y vs. N\] and PORT risk class \[III vs. IV/V\], using CMH stratum weights.|||3.1|-6.3|
70970309|NCT02813694|141446302|NON_INFERIORITY|non-inferiority margain = 10%|Treatment difference|-1.6|||||TWO_SIDED|95.0|-6.5|3.3|||||Difference in percentage of Success for IACR at test of cure visit. Confidence interval computed using a continuity-corrected Z-test.|||3.3|-6.5|
70909332|NCT02886728|141307199|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-2.0|<0.001
70909333|NCT02886728|141307199|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
70909334|NCT02886728|141307199|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-1.0|<0.001
70909335|NCT02886728|141307199|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.12|TWO_SIDED|95.0|-1.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.0|-1.0|0.12
70909336|NCT02886728|141307199|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.3||0.019|TWO_SIDED|95.0|-1.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-1.0|0.019
70909337|NCT02886728|141307199|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-2.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-2.0|<0.001
70909338|NCT02886728|141307199|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.3||0.032|TWO_SIDED|95.0|-1.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-1.0|0.032
70909339|NCT02886728|141307199|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-2.0|<0.001
70909340|NCT02886728|141307200|SUPERIORITY||Least Squares Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-13.0|-8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.0|-13.0|<0.001
70909341|NCT02886728|141307200|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-10.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-10.0|<0.001
70909342|NCT02886728|141307200|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-10.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-10.0|<0.001
70909343|NCT02886728|141307200|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-15.0|-10.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-10.0|-15.0|<0.001
70970310|NCT02813694|141446303|NON_INFERIORITY|non-inferiority margain = 10%|Treatment difference|-3.9|||||TWO_SIDED|95.0|-8.2|0.5|||||Difference in percentage of success for IACR at test of cure visit (Lefamulin - Moxifloxacin). CI computed via Miettinen-Nurminen method, adjusted for prior antibiotic use \[Y vs. N\]; PORT risk class \[III vs. IV/V\], using CMH stratum weights.|||0.5|-8.2|
70970311|NCT02813694|141446303|NON_INFERIORITY|non-inferiority margin = 10%|Treatment difference|-3.9|||||TWO_SIDED|95.0|-8.4|0.7|||||Difference in Percentage of Success for IACR at test of cure visit (Lefamulin - Moxifloxacin). Confidence interval computed using continuity-corrected Z-statistic.|||0.7|-8.4|
70970312|NCT01265797|141446304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|The Mann-Whitney U test was used to compare outcome measures between two treatment groups in the run-in month minus blinded month||The a priori alpha level was set at p \< 0.05, and a power of 0.80 (80%) was used to compute the number of subjects needed to find a meaningful difference between the verum and sham groups. Assuming that 20% of persons with the sham device and 60% of persons with CES device will meet the primary end point of ≥50% decrease in the frequency of headache days over the course of the study, 27 subjects are enrolled per group.||||0.30
70970313|NCT01265797|141446305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.89|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|The Mann-Whitney U test was used to compare secondary outcome measures between two treatment groups in the run-in month minus open label month||||||0.89
70970314|NCT01265797|141446306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.30
70970315|NCT01265797|141446307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.98|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|The Mann-Whitney U test was used to compare the primary and secondary outcome measures between the two treatment groups.||The a priori alpha level was set at p \< 0.05, and beta 0.2. Assuming that 20% of persons with the sham device and 60% of persons with CES device will meet the primary end point of ≥50% decrease in the frequency of headache days over the course of the study, 27 subjects are enrolled per group. The null hypothesis: No difference in the depression score/14 day recall between the two groups.||||0.98
70970316|NCT01265797|141446308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91||||0.75|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.75
70970317|NCT01265797|141446309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.73|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.73
70970318|NCT01265797|141446310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.74||||0.02|TWO_SIDED|||||Change in mean anxiety score/ 14 day recall from the blinded period to open label period|Wilcoxon (Mann-Whitney)|||||||0.02
70909344|NCT02886728|141307200|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.8||0.001|TWO_SIDED|95.0|-10.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-10.0|0.001
70970319|NCT01265797|141446311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.98|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.98
70970320|NCT01265797|141446312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.97|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.97
70970321|NCT01265797|141446313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.87|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.87
70970322|NCT01265797|141446314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.83|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.83
70970323|NCT01265797|141446315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.92|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.92
71045605|NCT02697773|141599468|SUPERIORITY|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.24||0.0065|TWO_SIDED|95.0|-1.14|-0.19||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed data sets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.19|-1.14|0.0065
70970324|NCT01179009|141446334|SUPERIORITY|||||||0.53||||||The p-value above represents the interaction between the treatment group and time.|ANOVA|||||||0.53
70970325|NCT01179009|141446335|SUPERIORITY|||||||0.06||||||The p-value above comes from a model where the treatment group is used to predict the CGI improvement score.|Ordinal regression|||||||0.06
70970326|NCT02943564|141446359|SUPERIORITY||Least Squares Mean Difference|0.1||||0.8862|TWO_SIDED|95.0|-1.5|1.73|||Mixed Model Repeated Measures (MMRM)|||||1.73|-1.50|0.8862
70970327|NCT02943564|141446359|SUPERIORITY||Least Squares Mean Difference|-0.5||||0.5772|TWO_SIDED|95.0|-2.07|1.16|||Mixed Model Repeated Measures (MMRM)|||||1.16|-2.07|0.5772
70970328|NCT02943564|141446360|SUPERIORITY||Least Squares Mean Difference|-0.1||||0.8967|TWO_SIDED|95.0|-1.48|1.29|||Mixed Model Repeated Measures (MMRM)|||||1.29|-1.48|0.8967
70970329|NCT02943564|141446360|SUPERIORITY||Least Squares Mean Difference|0.0||||0.9963|TWO_SIDED|95.0|-1.38|1.39|||Mixed Model Repeated Measures (MMRM)|||||1.39|-1.38|0.9963
70970330|NCT00577642|141446367|OTHER|single group|||||<|0.05|||||||t-test, 1 sided|||Paired t-tests were used to compare differences of NTX cytokine levels at study entry versus end-of-study.||||<0.05
70970331|NCT01556425|141446368|SUPERIORITY||Odds Ratio (OR)|2.26||||0.48|TWO_SIDED|95.0|0.2|21.6|||General Estimating Equation (GEE)|||||21.6|0.2|0.48
70970332|NCT01556425|141446368|SUPERIORITY||Odds Ratio (OR)|0.58||||0.61|TWO_SIDED|95.0|0.1|4.6|||General Estimating Equation (GEE)|||||4.6|0.1|0.61
70970333|NCT01556425|141446368|SUPERIORITY||Odds Ratio (OR)|6.0||||0.11|TWO_SIDED|95.0|0.7|54.9|||General Estimating Equation (GEE)|||||54.9|0.7|0.11
70970334|NCT01556425|141446368|SUPERIORITY||Odds Ratio (OR)|2.66||||0.39|TWO_SIDED|95.0|0.3|24.9|||General Estimating Equation (GEE)|||||24.9|0.3|0.39
70970335|NCT01556425|141446368|SUPERIORITY||Odds Ratio (OR)|10.4||||0.03|TWO_SIDED|95.0|1.3|85.5|||General Estimating Equation (GEE)|||||85.5|1.3|0.03
70970336|NCT01556425|141446369|SUPERIORITY||Odds Ratio (OR)|0.36||||0.3|TWO_SIDED|95.0|0.1|2.4|||General Estimating Equation (GEE)|||||2.4|0.1|0.30
70970337|NCT01556425|141446369|SUPERIORITY||Odds Ratio (OR)|0.2||||0.08|TWO_SIDED|95.0|0.03|1.2|||General Estimating Equation (GEE)|||||1.2|0.03|0.08
70970338|NCT01556425|141446369|SUPERIORITY||Odds Ratio (OR)|0.91||||0.91|TWO_SIDED|95.0|0.1|5.8|||General Estimating Equation (GEE)|||||5.8|0.1|0.91
70970339|NCT01556425|141446369|SUPERIORITY||Odds Ratio (OR)|2.47||||0.34|TWO_SIDED|95.0|0.4|15.8|||General Estimating Equation (GEE)|||||15.8|0.4|0.34
70970340|NCT01556425|141446369|SUPERIORITY||Odds Ratio (OR)|4.46||||0.09|TWO_SIDED|95.0|0.8|26.1|||General Estimating Equation (GEE)|||||26.1|0.8|0.09
70970341|NCT01505634|141446370|NON_INFERIORITY|Non-inferiority for the relebactam 250 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group was demonstrated if the lower bound of the 95% CI was not lower than the pre-specified non-inferiority margin of -15%.|Percent Difference|-3.1||||0.005|TWO_SIDED|95.0|-11.2|3.2|||Miettinen and Nurminen||Relebactam minus Placebo|Percent Difference (Diff) in Favorable MR||3.2|-11.2|0.005
70970342|NCT01505634|141446370|NON_INFERIORITY|Non-inferiority for the relebactam 125 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group was demonstrated if the lower bound of the 95% CI was not lower than the pre-specified non-inferiority margin of -15%.|Percent Difference|-0.1|||<|0.001|TWO_SIDED|95.0|-6.4|5.9|||Miettinen and Nurminen||Relebactam minus Placebo|Percent Diff in Favorable MR||5.9|-6.4|< 0.001
70970343|NCT01505634|141446371|OTHER|ECI #1 is a confirmed elevated AST or ALT ≥5X ULN. Inferential testing for statistical significance with p-values and 95% confidence intervals was performed to provide a comparison between the relebactam 250 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group.|Percent Difference|1.0||||0.315|TWO_SIDED|95.0|-2.7|5.5|||Miettinen and Nurminen||Relebactam minus Placebo|Percent Diff in Participants with Event of Clinical Interest (ECI) #1||5.5|-2.7|0.315
70970344|NCT01505634|141446371|OTHER|ECI #1 is a confirmed elevated AST or ALT ≥5X ULN. Inferential testing for statistical significance with p-values and 95% confidence intervals was performed to provide a comparison between the relebactam 125 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group.|Percent Difference|1.0||||0.315|TWO_SIDED|95.0|-2.7|5.5|||Miettinen and Nurminen||Relebactam minus Placebo|Percent Diff in Participants with ECI #1||5.5|-2.7|0.315
70970345|NCT01505634|141446372|OTHER|Event of Clinical Interest (ECI) #2 is elevated AST or ALT ≥3X ULN, elevated total bilirubin ≥2X ULN, and with an ALP \<2X ULN. Inferential testing for statistical significance with p-values and 95% confidence intervals was performed to provide a comparison between the relebactam 250 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group.|Percent Difference|0.0|||>|0.999|TWO_SIDED|95.0|-3.7|3.8||No participants met the criteria for ECI #2.|Miettinen and Nurminen||Relebactam minus Placebo|Percent Diff Participants with ECI #2||3.8|-3.7|> 0.999
70909345|NCT02886728|141307200|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.8|<|0.001|TWO_SIDED|95.0|-11.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-11.0|<0.001
70970346|NCT01505634|141446372|OTHER|Event of Clinical Interest (ECI) #2 is elevated AST or ALT ≥3X ULN, elevated total bilirubin ≥2X ULN, and with an ALP \<2X ULN. Inferential testing for statistical significance with p-values and 95% confidence intervals was performed to provide a comparison between the relebactam 125 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group.|Percent Difference|0.0|||>|0.999|TWO_SIDED|95.0|-3.7|3.8||No participants met the criteria for ECI #2.|Miettinen and Nurminen||Relebactam minus Placebo|Percent Diff in Participants with ECI #2||3.8|-3.7|> 0.999
70970347|NCT01505634|141446373|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-1.7||||||95.0|-14.3|10.9|||||Relebactam minus Placebo|Percent Diff in Participants with AEs||10.9|-14.3|
70970348|NCT01505634|141446373|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-0.7|||||TWO_SIDED|95.0|-13.4|12.0|||||Relebactam minus Placebo|Percent Diff in Participants with AEs||12.0|-13.4|
70970349|NCT01505634|141446374|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|0.0|||||TWO_SIDED|95.0|-5.8|5.9|||||Relebactam minus Placebo|Percent Diff in Participants with SAEs||5.9|-5.8|
70970350|NCT01505634|141446374|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-2.0|||||TWO_SIDED|95.0|-7.6|2.8|||||Relebactam minus Placebo|Percent Diff in Participants with SAEs||2.8|-7.6|
70970351|NCT01505634|141446375|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|1.1|||||TWO_SIDED|95.0|-7.5|9.8|||||Relebactam minus Placebo|Percent Diff in Participants with DR AEs||9.8|-7.5|
70970352|NCT01505634|141446375|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|0.1|||||TWO_SIDED|95.0|-8.4|8.6|||||Relebactam minus Placebo|Percent Diff in Participants with DR AEs||8.6|-8.4|
70970353|NCT01505634|141446376|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|0.0|||||TWO_SIDED|95.0|-4.5|4.6|||||Relebactam minus Placebo|Percent Diff in Participants with DR SAEs||4.6|-4.5|
70970354|NCT01505634|141446376|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-1.0|||||TWO_SIDED|95.0|-5.5|2.8|||||Relebactam minus Placebo|Percent Diff in Participants with DR SAEs||2.8|-5.5|
71153646|NCT03051178|141799829|SUPERIORITY||||||<|0.01||||||All post-hoc comparisons were Bonferroni corrected.|ANOVA|||TRS scores measured across different stimulation conditions were assessed using a mixed model ANOVA with the participant as a random effect. All post-hoc comparisons were Bonferroni corrected.||||<0.01
70970355|NCT01505634|141446377|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|1.0|||||TWO_SIDED|95.0|-4.4|6.8|||||Relebactam minus Placebo|Percent Diff in Participants with Discons Due to AEs||6.8|-4.4|
70970356|NCT01505634|141446377|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-1.0|||||TWO_SIDED|95.0|-6.1|3.7|||||Relebactam minus Placebo|Percent Diff in Participants with Discons Due to AEs||3.7|-6.1|
70970357|NCT01505634|141446378|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|1.0|||||TWO_SIDED|95.0|-3.6|6.2|||||Relebactam minus Placebo|Percent Diff in Participants with Discons Due to DR AEs||6.2|-3.6|
70970358|NCT01505634|141446378|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|0.0|||||TWO_SIDED|95.0|-4.5|4.6|||||Relebactam minus Placebo|Percent Diff in Participants with Discons Due to DR AEs||4.6|-4.5|
70970359|NCT01505634|141446379|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|1.1|||||TWO_SIDED|95.0|-5.5|7.8|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Diarrhoea||7.8|-5.5|
70970360|NCT01505634|141446379|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-2.0|||||TWO_SIDED|95.0|-8.1|3.6|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Diarrhoea||3.6|-8.1|
70970361|NCT01505634|141446379|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|0.0|||||TWO_SIDED|95.0|-6.4|6.5|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Nausea||6.5|-6.4|
70970362|NCT01505634|141446379|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|2.1|||||TWO_SIDED|95.0|-4.6|9.2|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Nausea||9.2|-4.6|
70970363|NCT01505634|141446379|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-3.0|||||TWO_SIDED|95.0|-9.0|1.9|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Bacteriuria||1.9|-9.0|
70970364|NCT01505634|141446379|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-2.0|||||TWO_SIDED|95.0|-8.1|3.6|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Bacteriuria||3.6|-8.1|
70970365|NCT01505634|141446379|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-3.0|||||TWO_SIDED|95.0|-9.0|1.9|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: White blood cells urine positive||1.9|-9.0|
70970366|NCT01505634|141446379|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-3.0|||||TWO_SIDED|95.0|-9.0|1.9|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: White blood cells urine positive||1.9|-9.0|
70970367|NCT01505634|141446379|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|3.1|||||TWO_SIDED|95.0|-3.7|10.4|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Headache||10.4|-3.7|
70970368|NCT01505634|141446379|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-1.0|||||TWO_SIDED|95.0|-7.2|5.1|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Headache||5.1|-7.2|
70970369|NCT02054897|141446386|SUPERIORITY|Superiority for change in HbA1c was claimed if the upper limit of the 2-sided 95% confidence interval (CI) for the estimated difference was below 0%.|Treatment difference|-1.53|||<|0.0001|TWO_SIDED|95.0|-1.81|-1.25|||Mixed Models Analysis||Semaglutide 1.0 mg minus Placebo|For the primary HbA1c endpoint, superiority was planned to be tested for semaglutide 1.0 mg versus placebo. The post-baseline responses were analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.||-1.25|-1.81|< 0.0001
70970370|NCT02054897|141446386|SUPERIORITY|Superiority for change in HbA1c was claimed if the upper limit of the 2-sided 95% CI for the estimated difference was below 0%.|Treatment difference|-1.43|||<|0.0001|TWO_SIDED|95.0|-1.71|-1.15|||Mixed Models Analysis||Semaglutide 0.5 mg minus Placebo|For the primary HbA1c endpoint, superiority was planned to be tested for semaglutide 0.5 mg versus placebo, if superiority for semaglutide 1.0 mg was concluded. The post-baseline responses were analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.||-1.15|-1.71|< 0.0001
70970371|NCT00401375|141446407|OTHER||Mean Difference (Final Values)|-0.23||||0.4259||||||Threshold for significance at 0.05 level.|Log Rank|||Treatment comparisons were made at the overall α=0.05 level (2-sided) using a closed sequential procedure. Placebo and MNTX 24 mg groups were compared first.||||0.4259
70970372|NCT00401375|141446407|OTHER||Mean Difference (Final Values)|0.13||||0.3575||||||Threshold for significance at 0.05 level.|Log Rank|||Treatment comparisons were made at the overall α=0.05 level (2-sided) using a closed sequential procedure. Placebo and MNTX 24 mg groups were compared first.||||0.3575
71030662|NCT01029353|141569508|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Preoperative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.81, 95% credible interval of (0.63, 1.00). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.09, 95% credible interval of (0.90, 1.33).|||
70970373|NCT00950664|141446414|NON_INFERIORITY_OR_EQUIVALENCE|81 participants required to detect 5 difference in Tsui score, with 80% power. 20% drop out rate assumed, 102 participants needed. Alpha level of 0.05.||||||0.05||95.0|||||Paired-t test|||||||0.05
70970374|NCT00677014|141446429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.66||95.0|||||ANOVA|As LVESV values were non normal by Q-Q analysis and Shapiro-Wilk test (p\<.05), a square root transform was used. model adjusted for baseline LVESV.||Gate keeping strategy utilized for Type 1 error control described in design paper - negative results observed for initial comparisons - (each at alpha = .05) between fixed and algorithm optimized AV delay and fixed and Echo optimzied AV. Results from both of these comparisons were non-significant.||||.66
70970375|NCT02374099|141446431|SUPERIORITY||Hazard Ratio (HR)|0.87|||=|0.599|TWO_SIDED|95.0|0.54|1.42|||Log Rank||||Hazard ratio and associated two-sided 95% confidence intervals (CI) were estimated by the Cox proportional hazard models.|1.42|0.54|= 0.599
70970376|NCT02374099|141446432|SUPERIORITY||Difference in Response Rates|6.3|||=|0.1479|TWO_SIDED|95.0|-2.47|15.06|||Fisher Exact||||The two-sided 95% confidence interval for the difference in ORR was estimated by the Wilson method.|15.06|-2.47|= 0.1479
70970377|NCT02374099|141446433|SUPERIORITY||Difference in Clinical Benefit Rate|0.7|||=|0.1732|TWO_SIDED|95.0|-17.76|19.04|||Fisher Exact||||The two-sided 95% confidence interval for the difference in clinical benefit rate was estimated by the Wilson method.|19.04|-17.76|= 0.1732
70970378|NCT02374099|141446434|SUPERIORITY||Hazard Ratio (HR)|0.59|||=|0.2725|TWO_SIDED|95.0|0.23|1.53|||Log Rank||||Hazard Ratio and associated two-sided 95% CI were estimated by the Cox proportional hazard model.|1.53|0.23|= 0.2725
70970379|NCT03449095|141446443|SUPERIORITY||||||<|0.001||||||The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|ANOVA|||||||<0.001
70970380|NCT03449095|141446444|SUPERIORITY|||||||0.001||||||The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|ANCOVA|||||||.001
70970381|NCT02909985|141446574|SUPERIORITY||F|23.68|||<|0.0001|TWO_SIDED||||||ANOVA|(9, 129)||||||<0.0001
70970382|NCT02909985|141446574|SUPERIORITY||F|9.4394|||<|0.0001|TWO_SIDED||||||ANOVA|(11, 52)||||||<0.0001
70970383|NCT04649255|141446588|OTHER||Exact binomial|96.4|||<|0.025|TWO_SIDED|95.0|96.4|100.0|||One-sided exact binomial test|Exact binomial one-sided lower 97.5% CI for performance goal test \>72% for primary effectiveness and \>82% for primary safety.||Descriptive assessment; H0: Ps ≤ PGS, versus HA: PS \> PGS, where where Ps is the population primary safety success rate in the Test group and PGS is the safety performance goal of 82%.||100|96.4|<0.025
70970384|NCT04649255|141446589|OTHER||Exact binomial|89.1|||<|0.025|TWO_SIDED|95.0|89.1|97.5|||One-sided exact binomial test|Exact binomial one-sided lower 97.5% CI for performance goal test \>72% for primary effectiveness and \>82% for primary safety.||Descriptive assessment; H0: PE ≤ PGE, versus HA: PE \> PGE, where PE is the proportion of target lesions with clinical success and PGE is the effectiveness performance goal of 72%.||97.5|89.1|<0.025
70970385|NCT01908101|141446691|OTHER|comparison analysis|Median Difference (Final Values)|3.5|||||TWO_SIDED|95.0|2.6|4.6||comparison analysis; no P value|||The estimated value is 3.5 months, not years.|Progression free survival (PFS). We hypothesize that metronomic dosing of eribulin will result in a PFS of 4-6 months.||4.6|2.6|
70970386|NCT00166205|141446692|SUPERIORITY_OR_OTHER||Percent of ITT subjects|69.6||||||95.0|63.8|74.9||||||A sample size of 215, the adverse event (AE) rate at three years could be estimated with precision as determined by the interval half-width of approximately ± 7%.||74.9|63.8|
70970387|NCT00166205|141446693|SUPERIORITY_OR_OTHER||Mean|75.7|STANDARD_DEVIATION|39.8||||95.0|70.5|80.8||||||||80.8|70.5|
70970388|NCT00166205|141446694|SUPERIORITY_OR_OTHER||Mean|35.7|STANDARD_DEVIATION|6.2||||95.0|34.9|36.5||||||||36.5|34.9|
70909346|NCT02886728|141307200|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-15.0|-9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-9.0|-15.0|<0.001
70970389|NCT00166205|141446695|SUPERIORITY_OR_OTHER||Mean|51.3|STANDARD_DEVIATION|45.8||||95.0|47.6|54.9||||||||54.9|47.6|
70970390|NCT00166205|141446696|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.4|STANDARD_DEVIATION|10.3||||95.0|9.2|11.7|||||Value at 36 months minus value at baseline. Positive values indicate improved Quality of Life (QOL)|||11.7|9.2|
71153647|NCT02268175|141799833|SUPERIORITY|||||||0.151||||||1-sided|Fisher Exact|||The hypothesis was that treatment with ARM 1 will have a pCR/MRD rate of 35% compared with Arm 2 rate of 10%. Given 75 men randomized in 2:1 ratio to Arm 1 (N=50) or Arm 2 (N=25), there was 84% power to detect this difference, using Fisher's exact test with one-sided type I error of 0.1.||||0.151
70970391|NCT00166205|141446697|SUPERIORITY_OR_OTHER||Mean|5.7|STANDARD_DEVIATION|0.7||||95.0|5.6|5.8||||||||5.8|5.6|
70970392|NCT00166205|141446699|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||A one-sided paired t-test would have 80% power to reject the null hypothesis in favor of the alternative (i.e., that the SAGB system is not inferior to the clinically meaningful result of 36.2 for 224 subjects) assuming: a standard deviation (SD) of (21.6), an equivalent limit difference of (3.6), and a significance level of 0.05.||||<0.001
70970393|NCT00166205|141446700|SUPERIORITY_OR_OTHER||Mean|56.4|STANDARD_DEVIATION|14.7||||95.0|54.5|58.4||||||||58.4|54.5|
70970394|NCT00166205|141446701|SUPERIORITY_OR_OTHER||Mean|114.5|STANDARD_DEVIATION|32.3||||95.0|110.1|118.8||||||||118.8|110.1|
70970395|NCT00166205|141446702|SUPERIORITY_OR_OTHER||Mean|193.5|STANDARD_DEVIATION|36.9||||95.0|188.6|198.4||||||||198.4|188.6|
70970396|NCT03787472|141446710|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.|Least-Square Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|2.98|||TWO_SIDED|95.0|-5.5|6.6|||Linear Mixed Model|The Kenward and Roger method was used for the calculation of the denominator of degrees of freedom.|Mean difference was calculated as Test - Control|||6.6|-5.5|
70970397|NCT03787472|141446711|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the upper confidence limit of LSM difference is below the non-inferiority margin 0.05 logMAR.|Least-Square Mean Difference|0.008|STANDARD_ERROR_OF_MEAN|0.0166|||TWO_SIDED|95.0|-0.025|0.041|||Linear Mixed Model||Mean difference was calculated as Test - Control|Distance Standard High Contrast Bright||0.041|-0.025|
70970398|NCT03787472|141446711|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the upper confidence limit of LSM difference is below the non-inferiority margin 0.05 logMAR.|Least-Square Mean Difference|-0.012|STANDARD_ERROR_OF_MEAN|0.0155|||TWO_SIDED|95.0|-0.043|0.019|||Linear Mixed Model||Mean difference was calculated as Test - Control|Intermediate Standard High Contrast Bright||0.019|-0.043|
70970399|NCT03787472|141446711|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the upper confidence limit of LSM difference is below the non-inferiority margin 0.05 logMAR.|Least-Square Mean Difference|0.003|STANDARD_ERROR_OF_MEAN|0.0169|||TWO_SIDED|95.0|-0.03|0.037|||Linear Mixed Model||Mean difference was calculated as Test - Control|Near Standard High Contrast Bright||0.037|-0.030|
71030663|NCT01029353|141569509|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.52|1.13|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.13|0.52|
71030664|NCT01029353|141569509|SUPERIORITY||Risk Ratio (RR)|1.28|||||TWO_SIDED|95.0|0.79|2.06|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||2.06|0.79|
71030665|NCT01029353|141569509|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Preoperative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.82, 95% credible interval of (0.53, 1.20). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.18, 95% credible interval of (0.74, 1.87).|||
71030666|NCT01029353|141569510|SUPERIORITY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.42|1.27|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.27|0.42|
71030667|NCT01029353|141569510|SUPERIORITY||Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.85|1.45|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.45|0.85|
71030668|NCT01029353|141569510|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Pre-operative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.76, 95% credible interval of (0.48, 1.18). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.08, 95% credible interval of (0.83, 1.42).|||
71030669|NCT01029353|141569511|SUPERIORITY||Risk Ratio (RR)|0.7|||||TWO_SIDED|95.0|0.47|1.05|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.05|0.47|
71030670|NCT01029353|141569511|SUPERIORITY||Risk Ratio (RR)|0.95|||||TWO_SIDED|95.0|0.76|1.19|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.19|0.76|
71030671|NCT01029353|141569511|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Preoperative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.73, 95% credible interval of (0.52, 0.96). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.95, 95% credible interval of (0.68, 1.32).|||
70909347|NCT02886728|141307200|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|2.0||0.009|TWO_SIDED|95.0|-9.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-9.0|0.009
70909348|NCT02886728|141307200|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|2.0||0.003|TWO_SIDED|95.0|-10.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-10.0|0.003
70909349|NCT02886728|141307200|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-13.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-13.0|<0.001
70909350|NCT02886728|141307200|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|2.0||0.11|TWO_SIDED|95.0|-7.0|1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.0|-7.0|0.11
70909351|NCT02886728|141307200|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|2.0||0.066|TWO_SIDED|95.0|-8.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.0|-8.0|0.066
70909352|NCT02886728|141307200|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-11.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-11.0|<0.001
70909353|NCT02886728|141307200|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.1||0.4|TWO_SIDED|95.0|-6.0|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-6.0|0.40
70909354|NCT02886728|141307200|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.1||0.24|TWO_SIDED|95.0|-6.0|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-6.0|0.24
70909355|NCT02886728|141307200|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-12.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-12.0|<0.001
70909356|NCT02886728|141307200|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|2.1||0.17|TWO_SIDED|95.0|-7.0|1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.0|-7.0|0.17
70909357|NCT02886728|141307200|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|2.1||0.008|TWO_SIDED|95.0|-10.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-10.0|0.008
70909358|NCT02886728|141307201|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-12.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-12.0|<0.001
70970400|NCT04091087|141446712|SUPERIORITY||Least square (LS) mean difference|-14.36|STANDARD_ERROR_OF_MEAN|7.47||0.0299|TWO_SIDED|90.0|-26.87|-1.86||1-sided|ANOVA|||||-1.86|-26.87|0.0299
70970401|NCT04091087|141446713|SUPERIORITY||Difference in percentage of participants|3.33||||0.1546|TWO_SIDED|90.0|-2.06|8.72||1-sided|Normal approximation test|||||8.72|-2.06|0.1546
70970402|NCT04091087|141446714|SUPERIORITY||Difference in percentage of participants|9.0||||0.0819|TWO_SIDED|90.0|-1.63|19.62||1-sided|Normal approximation test|||Week 1||19.62|-1.63|0.0819
70970403|NCT04091087|141446714|SUPERIORITY||Difference in percentage of participants|-0.47||||0.4789|TWO_SIDED|90.0|-15.2|14.25||1-sided|Normal approximation test|||Week 2||14.25|-15.20|0.4789
70970404|NCT04091087|141446714|SUPERIORITY||Difference in percentage of participants|-0.38||||0.4815|TWO_SIDED|90.0|-13.79|13.03||1-sided|Normal approximation test|||Week 3||13.03|-13.79|0.4815
70970405|NCT04091087|141446714|SUPERIORITY||Difference in percentage of participants|-0.38||||0.4815|TWO_SIDED|90.0|-13.79|13.03||1-sided|Normal approximation test|||Week 4||13.03|-13.79|0.4815
70970406|NCT04091087|141446714|SUPERIORITY||Difference in percentage of participants|8.9||||0.1197|TWO_SIDED|90.0|-3.55|21.35||1-sided|Normal approximation test|||Week 5||21.35|-3.55|0.1197
70970407|NCT04091087|141446714|SUPERIORITY||Difference in percentage of participants|18.18||||0.0034|TWO_SIDED|90.0|7.14|29.23||1-sided|Normal approximation test|||Week 6||29.23|7.14|0.0034
70970408|NCT04091087|141446715|SUPERIORITY||Difference in percentage of participants|5.13||||0.2896|TWO_SIDED|90.0|-10.09|20.34||1-sided|Normal approximation test|||||20.34|-10.09|0.2896
70970409|NCT04091087|141446716|SUPERIORITY||Difference in percentage of participants|7.77||||0.2648|TWO_SIDED|90.0|-12.55|28.08||1-sided|Normal approximation test|||Week 1||28.08|-12.55|0.2648
70970410|NCT04091087|141446716|SUPERIORITY||Difference in percentage of participants|17.05||||0.0809|TWO_SIDED|90.0|-2.99|37.08||1-sided|Normal approximation test|||Week 2||37.08|-2.99|0.0809
70970411|NCT04091087|141446716|SUPERIORITY||Difference in percentage of participants|1.7||||0.445|TWO_SIDED|90.0|-18.58|21.99||1-sided|Normal approximation test|||Week 3||21.99|-18.58|0.4450
70970412|NCT04091087|141446716|SUPERIORITY||Difference in percentage of participants|1.7||||0.445|TWO_SIDED|90.0|-18.58|21.99||1-sided|Normal approximation test|||Week 4||21.99|-18.58|0.4450
70970413|NCT04091087|141446716|SUPERIORITY||Difference in percentage of participants|20.45||||0.0385|TWO_SIDED|90.0|1.43|39.48||1-sided|Normal approximation test|||Week 5||39.48|1.43|0.0385
70970414|NCT04091087|141446716|SUPERIORITY||Difference in percentage of participants|29.64||||0.0045|TWO_SIDED|90.0|10.95|48.33||1 sided|Normal approximation test|||Week 6||48.33|10.95|0.0045
70970415|NCT04091087|141446717|SUPERIORITY||LS mean Difference|3.88|STANDARD_ERROR_OF_MEAN|13.49||0.3874|TWO_SIDED|90.0|-18.67|26.43||1-sided|Normal approximation test|||Week 1||26.43|-18.67|0.3874
70970416|NCT04091087|141446717|SUPERIORITY||LS mean Difference|-4.47|STANDARD_ERROR_OF_MEAN|11.59||0.3506|TWO_SIDED|90.0|-23.85|14.91||1-sided|Normal approximation test|||Week 2||14.91|-23.85|0.3506
70970417|NCT04091087|141446717|SUPERIORITY||LS mean Difference|9.81|STANDARD_ERROR_OF_MEAN|14.23||0.2466|TWO_SIDED|90.0|-13.97|33.6||1-sided|Normal approximation test|||Week 3||33.60|-13.97|0.2466
70970418|NCT04091087|141446717|SUPERIORITY||LS mean Difference|34.74|STANDARD_ERROR_OF_MEAN|15.74||0.0157|TWO_SIDED|90.0|8.43|61.05||1-sided|Normal approximation test|||Week 4||61.05|8.43|0.0157
70970419|NCT04091087|141446717|SUPERIORITY||LS mean Difference|-1.66|STANDARD_ERROR_OF_MEAN|14.55||0.4548|TWO_SIDED|90.0|-25.99|22.68||1-sided|Normal approximation test|||Week 5||22.68|-25.99|0.4548
70970420|NCT04091087|141446717|SUPERIORITY||LS mean Difference|-42.19|STANDARD_ERROR_OF_MEAN|11.99||0.0004|TWO_SIDED|90.0|-62.24|-22.15||1-sided|Normal approximation test|||Week 6||-22.15|-62.24|0.0004
70970421|NCT04091087|141446718|SUPERIORITY||LS mean difference|6.91|STANDARD_ERROR_OF_MEAN|9.65||0.2383|TWO_SIDED|90.0|-9.23|23.06||1 sided|ANOVA|||||23.06|-9.23|0.2383
70970422|NCT04091087|141446719|SUPERIORITY||LS mean Difference|-29.95|STANDARD_ERROR_OF_MEAN|21.01||0.0797|TWO_SIDED|90.0|-65.09|5.18||1-sided|Normal approximation test|||Week 1||5.18|-65.09|0.0797
70970423|NCT04091087|141446719|SUPERIORITY||LS mean Difference|-14.39|STANDARD_ERROR_OF_MEAN|18.79||0.2236|TWO_SIDED|90.0|-45.81|17.04||1-sided|Normal approximation test|||Week 2||17.04|-45.81|0.2236
70970424|NCT04091087|141446719|SUPERIORITY||LS mean Difference|-9.94|STANDARD_ERROR_OF_MEAN|15.05||0.2559|TWO_SIDED|90.0|-35.12|15.24||1-sided|Normal approximation test|||Week 3||15.24|-35.12|0.2559
70970425|NCT04091087|141446719|SUPERIORITY||LS mean Difference|-16.01|STANDARD_ERROR_OF_MEAN|22.44||0.2392|TWO_SIDED|90.0|-53.54|21.52||1-sided|Normal approximation test|||Week 4||21.52|-53.54|0.2392
70970426|NCT04091087|141446719|SUPERIORITY||LS mean Difference|-13.01|STANDARD_ERROR_OF_MEAN|19.65||0.2553|TWO_SIDED|90.0|-45.87|19.85||1-sided|Normal approximation test|||Week 5||19.85|-45.87|0.2553
70970427|NCT04091087|141446719|SUPERIORITY||LS mean Difference|-53.01|STANDARD_ERROR_OF_MEAN|30.05||0.0416|TWO_SIDED|90.0|-103.26|-2.75||1-sided|Normal approximation test|||Week 6||-2.75|-103.26|0.0416
70970428|NCT00517595|141446725|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Log Rank|||Within Group 1 (N=48), patients with an ECOG of 0 at baseline (N=18) were compared to patients with an ECOG of 1 at baseline (N=30).||||0.02
70970429|NCT00517595|141446726|SUPERIORITY_OR_OTHER|||||||0.0041||95.0|||||Log Rank|||Within Group 1 (N=48), patients with an ECOG of 0 at baseline (N=18) were compared to patients with an ECOG of 1 at baseline (N=30).||||0.0041
70970430|NCT04152161|141446732|SUPERIORITY||Vaccine Efficacy|-0.049|||||TWO_SIDED|95.0|-0.431|0.23|||||Vaccine Efficacy (VE) = 1 - Hazard Ratio, with 95%CI equal to (VE lower limit, VE upper limit) = (1 - Hazard Ratio upper limit, 1 - Hazard Ratio lower limit)|||0.230|-0.431|
70970431|NCT04152161|141446732|SUPERIORITY||Hazard Ratio (HR)|1.049||||0.6193|TWO_SIDED|95.0|0.77|1.431|||Log Rank|The 1-sided p-value from the log-rank test was stratified by sex and age group.|Hazard ratio was calculated using a stratified Cox proportional hazards model, with sex and age group (10-11 years, 12-14 years, and \>14 years) as stratification variables.|||1.431|0.770|0.6193
70970432|NCT04152161|141446733|SUPERIORITY||Vaccine Efficacy|-0.009|||||TWO_SIDED|95.0|-0.395|0.27|||||Vaccine Efficacy (VE) = 1 - Hazard Ratio, with 95%CI equal to (VE lower limit, VE upper limit) = (1 - Hazard Ratio upper limit, 1 - Hazard Ratio lower limit)|||0.270|-0.395|
70970433|NCT04152161|141446733|SUPERIORITY||Hazard Ratio (HR)|1.009||||0.5224|TWO_SIDED|95.0|0.73|1.395|||Log Rank|The 1-sided p-value from the log-rank test was stratified by sex and age group.|Hazard ratio was calculated using a stratified Cox proportional hazards model, with sex and age group (10-11 years, 12-14 years, and \>14 years) as stratification variables.|||1.395|0.730|0.5224
70970434|NCT04152161|141446734|SUPERIORITY||Vaccine Efficacy|-0.049|||||TWO_SIDED|95.0|-0.431|0.23|||||Vaccine Efficacy (VE) = 1 - Hazard Ratio, with 95%CI equal to (VE lower limit, VE upper limit) = (1 - Hazard Ratio upper limit, 1 - Hazard Ratio lower limit)|||0.230|-0.431|
70970435|NCT04152161|141446734|SUPERIORITY||Hazard Ratio (HR)|1.049||||0.6193|TWO_SIDED|95.0|0.77|1.431|||Log Rank|The 1-sided p-value from the log-rank test was stratified by sex and age group.|Calculated using a stratified Cox proportional hazards model, with sex and age group (10-11 years, 12-14 years, and \>14 years) as stratification variables.|||1.431|0.770|0.6193
70970436|NCT03703102|141446748|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||< 0.001
70970437|NCT03703102|141446748|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||< 0.001
70970438|NCT03703102|141446748|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||< 0.001
70970439|NCT03703102|141446748|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||< 0.001
70970440|NCT01560780|141446803|SUPERIORITY|||||||0.78|||||||Fisher Exact|||||||0.78
70970441|NCT01560780|141446804|EQUIVALENCE|safety end-point with p-value of \<0.05|||||>|0.99|||||||Log Rank|||||||>0.99
70970442|NCT01560780|141446805|SUPERIORITY|||||||0.19|||||||Fisher Exact|||||||0.19
70970443|NCT01560780|141446806|SUPERIORITY|||||||0.85|||||||t-test, 2 sided|||||||0.85
70970444|NCT01560780|141446807|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
70970445|NCT01560780|141446809|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
70970446|NCT05074251|141446822|SUPERIORITY||Risk Ratio (RR)|1.41|||<|0.05|TWO_SIDED|95.0|1.14|1.75|||Regression, Logistic|||||1.75|1.14|<0.05
71030672|NCT01029353|141569512|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.61|1.06|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.06|0.61|
71030673|NCT01029353|141569512|SUPERIORITY||Risk Ratio (RR)|1.17|||||TWO_SIDED|95.0|1.01|1.37|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.37|1.01|
70970447|NCT03548935|141446849|SUPERIORITY||Treatment difference|-12.44|||<|0.0001|TWO_SIDED|95.0|-13.37|-11.51|||ANCOVA|||Treatment policy estimand||-11.51|-13.37|<.0001
70970448|NCT03548935|141446849|SUPERIORITY||Treatment difference|-14.42|||<|0.0001|TWO_SIDED|95.0|-15.29|-13.55|||ANCOVA|||Hypothetical estimand||-13.55|-15.29|<0.0001
70970449|NCT03548935|141446850|SUPERIORITY||Odds Ratio (OR)|11.22|||<|0.0001|TWO_SIDED|95.0|8.88|14.19|||Regression, Logistic|||Treatment policy estimand||14.19|8.88|<0.0001
70970450|NCT03548935|141446850|SUPERIORITY||Odds Ratio (OR)|37.03|||<|0.0001|TWO_SIDED|95.0|28.02|48.95|||Regression, Logistic|||Hypothetical estimand||48.95|28.02|<0.0001
70970451|NCT00763815|141446891|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.088|<|0.0001|TWO_SIDED|95.0|-0.731|-0.386||Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms; randomization strata of screening HbA1c (\<8.0, \>=8.0%), metformin use (yes, no); country as fixed effects; baseline HbA1c as covariate.|ANCOVA|||To detect a difference of 0.5% (or 0.4%) in change from baseline to Week 24 in HbA1c between lixisenatide and placebo, 300 patients in lixisenatide arm and 150 patients in placebo arm would provide a power of 96% (or 86%) assuming common standard deviation of 1.3% with a 2-sided test at 5% significance level.||-0.386|-0.731|<0.0001
70970452|NCT01604265|141446940|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.25||||0.005|TWO_SIDED|95.0|-2.11|-0.39|||ANCOVA|||The change was compared between treatment groups using a one way analysis of covariance (ANCOVA). The significance of the treatment effect, after adjusting for baseline pain score, was assessed using the F-test from the ANCOVA. The model was as follows: Change in 0-10 Numerical Rating Scale Pain Score = Baseline Pain Score + Treatment||-0.39|-2.11|0.005
70970453|NCT01604265|141446941|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.39||||0.003|TWO_SIDED|95.0|-2.27|-0.5|||ANCOVA|||"The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline sleep score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in 0-10 Numerical Rating Scale sleep Score = Baseline Sleep Score + Treatment"||-0.50|-2.27|0.003
70970454|NCT01604265|141446942|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.896||||0.005|TWO_SIDED|95.0|1.51|10.055|||Regression, Logistic|||"The proportion of patients who considered their condition Very Much Improved or Much Improved was compared between treatment groups using a Fisher's Exact Test. Results were presented in terms of difference in percentages, and 95% CI based on the normal approximation to the binomial, and p-value."||10.055|1.510|0.005
70970455|NCT01604265|141446943|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|-6.82||||0.039|TWO_SIDED|95.0|-13.28|-0.37|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||-0.37|-13.28|0.039
70970456|NCT01604265|141446944|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-6.95||||0.009|TWO_SIDED|95.0|-12.12|-1.77|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||-1.77|-12.12|0.009
70970457|NCT01604265|141446945|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|2.54||||0.23|TWO_SIDED|95.0|-1.64|6.71|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||6.71|-1.64|0.230
70970458|NCT01604265|141446946|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-2.53||||0.064|TWO_SIDED|95.0|-5.22|0.15|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||0.15|-5.22|0.064
70970459|NCT01604265|141446947|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|2.44||0.905|TWO_SIDED|95.0|-4.6|5.18|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||5.18|-4.60|0.905
70970460|NCT01604265|141446948|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|2.68||||0.257|TWO_SIDED|95.0|-2.01|7.37|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||7.37|-2.01|0.257
70970461|NCT01604265|141446949|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.5||||0.164|TWO_SIDED|95.0|-3.64|0.63|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||0.63|-3.64|0.164
70970462|NCT01604265|141446951|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.09||||0.88|TWO_SIDED|95.0|-1.06|1.23|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||1.23|-1.06|0.880
70970463|NCT01604265|141446952|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.64||||0.249|TWO_SIDED|95.0|-1.75|0.46|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||0.46|-1.75|0.249
70970464|NCT01604265|141446953|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.06||||0.535|TWO_SIDED|95.0|-0.13|0.24|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||0.24|-0.13|0.535
70970465|NCT02706873|141446955|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|23.7|||<|0.001|TWO_SIDED|95.0|16.3|31.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||31.1|16.3|<0.001
70970466|NCT02706873|141446955|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|28.0|||<|0.001|TWO_SIDED|95.0|20.6|35.4||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||35.4|20.6|<0.001
70970467|NCT02706873|141446956|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|29.8|||<|0.001|TWO_SIDED|95.0|22.8|36.8||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||36.8|22.8|<0.001
71030674|NCT01029353|141569512|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Preoperative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.80, 95% credible interval of (0.61, 1.01). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.15, 95% credible interval of (0.94, 1.42).|||
71030675|NCT01029353|141569513|SUPERIORITY||Risk Ratio (RR)|0.68|||||TWO_SIDED|95.0|0.46|1.01|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.01|0.46|
71153648|NCT03530124|141799875|SUPERIORITY|The number of infants with ≥1 apneic event for each group and compared using a Mantel-Haenszel statistic in a stratified analysis by study site and gestational age group (\< 28 weeks versus ≥ 28 weeks) to control for the randomization blocks at the two-sided alpha 0.05 level and corresponding 95% confidence interval for the occurrence of apnea.|Odds Ratio (OR)|2.7||||0.0104|TWO_SIDED|95.0|1.27|5.73|||Mantel Haenszel||No adjustments were made to the alpha level (two-sided alpha=0.05) for the primary objective.|||5.73|1.27|0.0104
70909359|NCT02886728|141307201|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-9.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-9.0|<0.001
70909360|NCT02886728|141307201|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-11.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-11.0|<0.001
70909361|NCT02886728|141307201|SUPERIORITY||Least Squares Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|95.0|-13.0|-8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.0|-13.0|<0.001
70909362|NCT02886728|141307201|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-11.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-11.0|<0.001
70909363|NCT02886728|141307201|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-11.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-11.0|<0.001
70909364|NCT02886728|141307201|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-12.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-12.0|<0.001
70909365|NCT02886728|141307201|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-9.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-9.0|<0.001
70909366|NCT02886728|141307201|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.6||0.001|TWO_SIDED|95.0|-8.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-8.0|0.001
70909367|NCT02886728|141307201|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-8.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-8.0|<0.001
70909368|NCT02886728|141307201|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.5||0.007|TWO_SIDED|95.0|-7.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-7.0|0.007
70909369|NCT02886728|141307201|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.5||0.046|TWO_SIDED|95.0|-6.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-6.0|0.046
70909370|NCT02886728|141307201|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.2||0.002|TWO_SIDED|95.0|-6.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-6.0|0.002
70909371|NCT02886728|141307201|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.4||0.44|TWO_SIDED|95.0|-4.0|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-4.0|0.44
71030676|NCT01029353|141569513|SUPERIORITY||Risk Ratio (RR)|1.22|||||TWO_SIDED|95.0|0.74|2.01|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||2.01|0.74|
71030677|NCT01029353|141569513|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Preoperative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.72, 95% credible interval of (0.48, 1.05). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.12, 95% credible interval of (0.71, 1.76).|||
71030678|NCT01029353|141569514|SUPERIORITY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.51|1.04|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.04|0.51|
71030679|NCT01029353|141569514|SUPERIORITY||Risk Ratio (RR)|1.25|||||TWO_SIDED|95.0|0.82|1.93|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates. Reported results in this analysis restricted to infants with IP.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.93|0.82|
71030680|NCT01029353|141569514|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Preoperative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.77, 95% credible interval of (0.51, 1.14). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.17, 95% credible interval of (0.76, 1.81).|||
71030681|NCT01029353|141569515|SUPERIORITY||Risk Ratio (RR)|0.53|||||TWO_SIDED|95.0|0.31|0.89|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||0.89|0.31|
71030682|NCT01029353|141569515|SUPERIORITY||Risk Ratio (RR)|0.44|||||TWO_SIDED|95.0|0.29|0.66|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||0.66|0.29|
71030683|NCT01029353|141569516|SUPERIORITY||Risk Ratio (RR)|1.44|||||TWO_SIDED|95.0|0.58|3.57|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||3.57|0.58|
71030684|NCT01029353|141569516|SUPERIORITY||Risk Ratio (RR)|1.63|||||TWO_SIDED|95.0|1.06|2.5|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||2.50|1.06|
71153649|NCT03530124|141799876|OTHER|The number of apnea events were compared using a linear regression model (assuming a Poisson distribution) with study site and gestational age group covariates to control for the randomization blocks.||||||0.11|||||||Regression, Linear|No adjustments were made to the alpha level (two-sided alpha=0.05) for the secondary objectives.||||||0.11
70909372|NCT02886728|141307201|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.4||0.21|TWO_SIDED|95.0|-5.0|1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.0|-5.0|0.21
71030685|NCT01029353|141569517|SUPERIORITY||Risk Ratio (RR)|2.52|||||TWO_SIDED|95.0|0.84|7.55|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||7.55|0.84|
71030686|NCT01029353|141569517|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.38|2.88|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||2.88|0.38|
71030687|NCT01029353|141569518|SUPERIORITY||Risk Ratio (RR)|1.78|||||TWO_SIDED|95.0|0.82|3.86|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||3.86|0.82|
71030688|NCT01029353|141569518|SUPERIORITY||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.42|3.2|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||3.20|0.42|
71030689|NCT01029353|141569519|SUPERIORITY||Risk Ratio (RR)|1.68|||||TWO_SIDED|95.0|0.35|8.05|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||8.05|0.35|
71030690|NCT01029353|141569519|SUPERIORITY||Risk Ratio (RR)|0.5|||||TWO_SIDED|95.0|0.1|2.44|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||2.44|0.10|
71030691|NCT01029353|141569520|SUPERIORITY||Risk Ratio (RR)|1.29|||||TWO_SIDED|95.0|0.62|2.69|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||2.69|0.62|
71030692|NCT01029353|141569520|SUPERIORITY||Risk Ratio (RR)|0.6|||||TWO_SIDED|95.0|0.27|1.32|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.32|0.27|
71092003|NCT02030600|141690591|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.40%|Treatment contrast|0.06|||||TWO_SIDED|95.0|-0.07|0.18||||||"Change from baseline in HbA1c at week 64 (treatment period 2). The baseline values are week 32 values. Before the primary endpoint was tested, the secondary supportive efficacy endpoint Change from baseline in HbA1c after 32 weeks of treatment was tested for non-inferiority as prerequisite for testing the primary endpoint. Analysis was performed using a MMRM with treatment, sex, antidiabetic therapy at screening, visit and dosing time as fixed effects, and age and baseline HbA1c as covariates."||0.18|-0.07|
71008711|NCT02055976|141525244|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.898|STANDARD_ERROR_OF_MEAN|2.84||0.001|TWO_SIDED|95.0|3.252|14.544|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||14.544|3.252|0.001
71030693|NCT01029353|141569521|SUPERIORITY||Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.41|1.36|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.36|0.41|
71030694|NCT01029353|141569521|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.69|1.42|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.42|0.69|
70909373|NCT02886728|141307201|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-7.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-7.0|<0.001
71030695|NCT01029353|141569522|SUPERIORITY||Risk Ratio (RR)|0.43|||||TWO_SIDED|95.0|0.04|4.45|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||4.45|0.04|
71030696|NCT01029353|141569522|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.44|1.49|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.49|0.44|
71030697|NCT01029353|141569523|SUPERIORITY||Mean Difference (Final Values)|-1.27|||||TWO_SIDED|95.0|-14.1|11.6|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to NEC.||11.60|-14.10|
71030698|NCT01029353|141569523|SUPERIORITY||Mean Difference (Final Values)|-7.85|||||TWO_SIDED|95.0|-15.84|0.13|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to IP.||0.13|-15.84|
71030699|NCT01029353|141569524|SUPERIORITY||Mean Difference (Final Values)|-11.57|||||TWO_SIDED|95.0|-27.15|4.01|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to NEC.||4.01|-27.15|
71030700|NCT01029353|141569524|SUPERIORITY||Mean Difference (Final Values)|-7.63|||||TWO_SIDED|95.0|-17.46|2.2|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to IP.||2.20|-17.46|
71030701|NCT01029353|141569525|SUPERIORITY||Mean Difference (Final Values)|4.0|||||TWO_SIDED|95.0|-18.84|26.83|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to NEC.||26.83|-18.84|
71030702|NCT01029353|141569525|SUPERIORITY||Mean Difference (Final Values)|9.05|||||TWO_SIDED|95.0|-13.29|31.38|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to IP.||31.38|-13.29|
71030703|NCT01029353|141569526|SUPERIORITY||Mean Difference (Final Values)|-3.13|||||TWO_SIDED|95.0|-24.62|18.36|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to NEC.||18.36|-24.62|
71030704|NCT01029353|141569526|SUPERIORITY||Mean Difference (Final Values)|-2.39|||||TWO_SIDED|95.0|-14.42|9.63|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates. Reported results in this analysis restricted to infants with IP.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to IP.||9.63|-14.42|
71030705|NCT01029353|141569527|SUPERIORITY||Mean Difference (Final Values)|-18.43|||||TWO_SIDED|95.0|-48.41|11.55|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to NEC.||11.55|-48.41|
71030706|NCT01029353|141569527|SUPERIORITY||Mean Difference (Final Values)|-11.95|||||TWO_SIDED|95.0|-31.96|8.06|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to IP.||8.06|-31.96|
71030707|NCT01520909|141569529|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.96|||<|0.001|TWO_SIDED|95.0|2.29|140.93|||Cochran-Mantel-Haenszel|The proportion of participants achieving platelet counts \>=50 Gi/L for those participants receiving eltrombopag versus placebo was compared.||Indicated significance at the 5% (two-sided) level of significance||140.93|2.29|<0.001
71030708|NCT01520909|141569530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|25.33|||<|0.001|TWO_SIDED|95.0|8.15|78.73|||Repeated measures model for binary data|Repeated measures model for binary data using Generalized linear mixed model||||78.73|8.15|<0.001
71030709|NCT00064753|141569580|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.99||||0.93|TWO_SIDED|95.0|0.84|1.17||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox|||||1.17|0.84|0.93
71030710|NCT00064753|141569581|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.15||||0.19|TWO_SIDED|95.0|0.93|1.43||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox|||||1.43|0.93|0.19
71030711|NCT00064753|141569582|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.04||||0.67|TWO_SIDED|95.0|0.86|1.26||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox|||||1.26|0.86|0.67
71030712|NCT00064753|141569583|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.08||||0.61|TWO_SIDED|95.0|0.8|1.45||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox|||||1.45|0.80|0.61
71030713|NCT00064753|141569584|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.12||||0.64|TWO_SIDED|95.0|0.69|1.81||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox|||||1.81|0.69|0.64
71030714|NCT00064753|141569585|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8||||0.66|TWO_SIDED|95.0|0.3|2.15||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox|||||2.15|0.30|0.66
71030715|NCT00064753|141569586|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.84||||0.28|TWO_SIDED|95.0|0.62|1.15|||Regression, Cox|||||1.15|0.62|0.28
71030716|NCT00064753|141569587|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.95||||0.7|TWO_SIDED|95.0|0.73|1.23|||Regression, Cox|P was calculated with stratified proportional hazards models stratified by country||||1.23|0.73|0.70
71030717|NCT00064753|141569588|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.14||||0.49|TWO_SIDED|95.0|0.79|1.65|||Regression, Cox|P was calculated with stratified proportional hazards models stratified by country||||1.65|0.79|0.49
71030718|NCT00064753|141569589|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.14||||0.78|TWO_SIDED|95.0|0.46|2.8|||Regression, Cox|P was calculated with stratified proportional hazards models stratified by country||||2.80|0.46|0.78
71030719|NCT00064753|141569590|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.61||||0.5|TWO_SIDED|95.0|0.15|2.57|||Regression, Cox|P was calculated with stratified proportional hazards models stratified by country||||2.57|0.15|0.50
71030720|NCT00064753|141569591|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.3||||0.6|TWO_SIDED|95.0|0.48|3.5|||Regression, Cox|P was calculated with stratified proportional hazards models stratified by country||||3.50|0.48|0.60
71030721|NCT03834870|141569593|OTHER||Percentage of enrolled from eligible|84.05|||||TWO_SIDED|95.0|81.98|86.1||||||||86.10|81.98|
71030722|NCT03834870|141569594|OTHER||Percentage of enrolled from eligible|99.01|||||TWO_SIDED|95.0|98.4|99.6||||||||99.60|98.40|
71030723|NCT01544127|141569602|SUPERIORITY||Odds Ratio (OR)|0.59|STANDARD_ERROR_OF_MEAN|0.19||0.054|TWO_SIDED|95.0|0.31|1.12||A priori, analyses were proposed to be one-sided, with p set at 0.05.|Zero-Inflated Poisson|Analysis adjusted for severity of worst TBI experience and used a robust standard error that was clustered on participants.|OR was calculated for number of participants with suicidal ideation. Analyses were one-sided, but two-sided confidence intervals for the OR are reported.|"MI-SI + TAU and MI-SI-R + TAU vs. TAU Alone~A hurdle model was used to examine the effect of the experimental interventions on the presence of suicidal ideation and the severity of suicidal ideation among those with it. These analyses examined the presence of suicidal ideation in the combined MI-SI + TAU and MI-SI-R + TAU treatment group."||1.12|0.31|.054
71030724|NCT01544127|141569602|SUPERIORITY||Odds Ratio (OR)|0.6|STANDARD_ERROR_OF_MEAN|0.26||0.12|TWO_SIDED|95.0|0.26|1.4||A priori, analyses were proposed as one-sided, with p set at 0.05.|Zero-Inflated Poisson|Analysis adjusted for severity of worst TBI experience and used a robust standard error that was clustered on participants.|OR was calculated for number of participants with suicidal ideation. Analyses were one-sided, but two-sided confidence intervals for the OR are reported.|MI-SI+TAU vs. TAU Alone||1.40|0.26|0.12
71030725|NCT01544127|141569602|SUPERIORITY||Odds Ratio (OR)|0.59|STANDARD_ERROR_OF_MEAN|0.22||0.08|TWO_SIDED|95.0|0.28|1.24||A priori, analyses were proposed as one-sided, with p set at 0.05.|Zero-Inflated Poisson|Analysis adjusted for severity of worst TBI experience and used a robust standard error that was clustered on participants.|OR was calculated for number of participants with suicidal ideation. Analyses were one-sided, but two-sided confidence intervals for the OR are reported.|MI-SI-R + TAU vs. TAU Alone||1.24|0.28|0.08
71030726|NCT01544127|141569603|SUPERIORITY||Beta|0.06|STANDARD_ERROR_OF_MEAN|0.11||0.3|TWO_SIDED|||||A priori, analyses were proposed to be one-sided, with p set at 0.05.|Zero-Inflated Poisson|A robust standard error clustered on participants was used.||"MI-SI + TAU vs. MI-SI-R + TAU vs. TAU Alone~A hurdle model was used to examine the effect of the experimental interventions on the presence/absence of suicidal ideation and the severity of suicidal ideation among those with it. These analyses examined the severity of suicidal ideation among participants with suicidal ideation in the combined MI-SI + TAU and MI-SI-R + TAU treatment group."||||0.30
71030727|NCT01544127|141569603|SUPERIORITY||Beta|0.09|STANDARD_ERROR_OF_MEAN|0.12||0.23|TWO_SIDED|||||A priori, analyses were proposed to be one-sided, with p set at 0.05.|Zero-Inflated Poisson|A robust standard error clustered on participants was used.||MI-SI vs. TAU Alone||||0.23
71030728|NCT01544127|141569603|SUPERIORITY||Beta|0.01|STANDARD_ERROR_OF_MEAN|0.13||0.46|TWO_SIDED|||||A priori, analyses were proposed to be one-sided, with p set at 0.05.|Zero-Inflated Poisson|A robust standard error clustered on participants was used.||MI-SI-R vs. TAU Alone||||0.46
71030729|NCT01544127|141569604|SUPERIORITY||Odds Ratio (OR)|1.03|STANDARD_ERROR_OF_MEAN|0.65||0.96|TWO_SIDED|0.95|0.3|3.54||A priori, p was set at 0.01 for multiple comparisons.|Regression, Logistic|||MI-SI + TAU vs. TAU Alone||3.54|0.30|0.96
71030730|NCT01544127|141569604|SUPERIORITY||Odds Ratio (OR)|0.68|STANDARD_ERROR_OF_MEAN|0.38||0.5|TWO_SIDED|95.0|0.23|2.06||A priori, p was set at 0.01 for multiple comparisons.|Regression, Logistic|||MI-SI-R + TAU vs. TAU Alone||2.06|0.23|0.50
71030731|NCT01544127|141569605|SUPERIORITY||Cox Proportional Hazard|1.69|STANDARD_ERROR_OF_MEAN|0.91||0.31|TWO_SIDED|95.0|0.59|4.88||A priori, p was set at 0.01 for multiple comparisons.|Log Rank|||MI-SI + TAU vs. TAU Alone||4.88|0.59|0.31
71030732|NCT01544127|141569605|SUPERIORITY||Cox Proportional Hazard|0.49|STANDARD_ERROR_OF_MEAN|0.39||0.24|TWO_SIDED|95.0|0.1|2.31||A priori, p was set at 0.01 for multiple comparisons.|Log Rank|||MI-SI-R vs. TAU Alone||2.31|0.10|0.24
71030733|NCT01544127|141569605|SUPERIORITY||Cox Proportional Hazard|0.29|STANDARD_ERROR_OF_MEAN|0.23||0.1|TWO_SIDED|95.0|0.06|1.43||A priori, p was set at 0.01 for multiple comparisons.|Log Rank|||"MI-SI-R + TAU vs. MI-SI + TAU~Because the impact of MI-SI + TAU and MI-SI-R + TAU were in different directions when compared to TAU Alone, they were compared. For this analysis, the null hypothesis was that the revisions did not change the impact of MI-SI + TAU."||1.43|0.06|0.10
71030734|NCT02870920|141569606|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.07|TWO_SIDED|90.0|0.54|0.97|||Log Rank|||||0.97|0.54|0.07
71030735|NCT02870920|141569607|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.97|TWO_SIDED|90.0|0.76|1.34|||Log Rank|||||1.34|0.76|0.97
71030736|NCT00533273|141569609|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<.001
71030737|NCT00533273|141569610|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<.001
71030738|NCT00533273|141569611|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
71030739|NCT00533273|141569612|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
71030740|NCT00533273|141569614|SUPERIORITY|||||||0.014|||||||Cochran-Mantel-Haenszel|||||||.014
71030741|NCT00533273|141569615|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<.0001
71030742|NCT00533273|141569616|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
71030743|NCT00533273|141569617|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
71030744|NCT00454909|141569632|SUPERIORITY||Difference in percentage|11.2|||||TWO_SIDED|95.0|3.87|19.18||||||Evaluation of the immunogenicity induced by Nimenrix™ conjugate vaccine as compared to Menactra® vaccine in terms of percentage of subjects with serum bactericidal assay using human complement against N. meningitidis serogroup A (hSBA-MenA) antibody titers ≥ 1:8 one month after vaccination.||19.18|3.87|
71030745|NCT00454909|141569632|SUPERIORITY||Difference in percentage|-2.77|||||TWO_SIDED|95.0|-5.08|0.4||||||Evaluation of the immunogenicity induced by Nimenrix™ conjugate vaccine as compared to Menactra® vaccine in terms of percentage of subjects with serum bactericidal assay using human complement against N. meningitidis serogroup C (hSBA-MenC) antibody titers ≥ 1:8 one month after vaccination.||0.40|-5.08|
71030746|NCT00454909|141569632|SUPERIORITY||Difference in percentage|14.93|||||TWO_SIDED|95.0|8.24|22.71||||||Evaluation of the immunogenicity induced by Nimenrix™ conjugate vaccine as compared to Menactra® vaccine in terms of percentage of subjects with serum bactericidal assay using human complement against N. meningitidis serogroup W-135 (hSBA-MenW -135) antibody titers ≥ 1:8 one month after vaccination.||22.71|8.24|
71030747|NCT00454909|141569632|SUPERIORITY||Difference in percentage|13.4|||||TWO_SIDED|95.0|7.9|20.1||||||Evaluation of the immunogenicity induced by Nimenrix™ conjugate vaccine as compared to Menactra® vaccine in terms of percentage of subjects with serum bactericidal assay using human complement against N. meningitidis serogroup Y (hSBA-MenY) antibody titers ≥ 1:8 one month after vaccination.||20.10|7.90|
71030748|NCT00819507|141569678|SUPERIORITY||Mean Difference (Final Values)|6.01|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
71030749|NCT00819507|141569679|SUPERIORITY||Median Difference (Final Values)|14.35|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
71030750|NCT01376167|141569697|SUPERIORITY||Hazard Ratio (HR)|0.299|||<|0.001|TWO_SIDED|95.0|0.222|0.404||The Cox proportional hazards model was fitted with region and treatment as covariates.|Cox Proportional Hazards Model||A hazard ratio\<1 indicated a lower chance of relapse compared to CQ only.|||0.404|0.222|<0.001
71030751|NCT01376167|141569697|SUPERIORITY||Hazard Ratio (HR)|0.262|||<|0.001|TWO_SIDED|95.0|0.178|0.387||The Cox proportional hazards model was fitted with region and treatment as covariates.|Cox Proportional Hazards Model||A hazard ratio\<1 indicated a lower chance of relapse compared to CQ only.|||0.387|0.178|<0.001
71030752|NCT01376167|141569697|SUPERIORITY||Odds Ratio (OR)|0.241|||<|0.001|TWO_SIDED|95.0|0.152|0.382||Logistic regression model was fitted with region and treatment as covariates. Participants with a zero P vivax asexual parasite count at Baseline were excluded from the analysis.|Regression, Logistic||Odds ratios \< 1 suggested a smaller chance of recurrence compared to CQ Only.|||0.382|0.152|<0.001
71030753|NCT01376167|141569697|SUPERIORITY||Odds Ratio (OR)|0.198|||<|0.001|TWO_SIDED|95.0|0.117|0.335||Logistic regression model was fitted with region and treatment as covariates. Participants with a zero P vivax asexual parasite count at Baseline were excluded from the analysis.|Regression, Logistic||Odds ratios \< 1 suggested a smaller chance of recurrence compared to CQ Only.|||0.335|0.117|<0.001
71030754|NCT01376167|141569698|SUPERIORITY||Hazard Ratio (HR)|0.271|||<|0.001|TWO_SIDED|95.0|0.195|0.376||The Cox proportional hazards model was fitted with region and treatment as covariates.|Cox Proportional Hazards Model||A hazard ratio\<1 indicated a lower chance of relapse compared to CQ only.|||0.376|0.195|<0.001
71030755|NCT01376167|141569698|SUPERIORITY||Hazard Ratio (HR)|0.255|||<|0.001|TWO_SIDED|95.0|0.167|0.39||The Cox proportional hazards model was fitted with region and treatment as covariates.|Cox Proportional Hazards Model||A hazard ratio\<1 indicated a lower chance of relapse compared to CQ only.|||0.390|0.167|<0.001
71030756|NCT00565448|141569751|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|95.0||||The Fisher's exact test was used to compare the CR proportions.|Fisher Exact|||There was no formal power calculation. A selection design was used to determine how many participants would be accrued to correctly select the treatment group with the best CR rate with 80% probability.||||1.0000
71030757|NCT02016170|141569770|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was assessed using a 95% confidence interval (CI) of the difference in mean PRU between prasugrel and ticagrelor (two arms combined). Under the assumption of 0 difference in mean PRU between ticagrelor 90 mg bid MD and prasugrel 10 mg qd MD and a common standard deviation of 60 PRU, a sample size of 24 patients per group allowed for the 95% CI to stay within ± 45 PRU with a 90% power and alpha=0.05.|Mean Difference (Final Values)|-18.0|||||TWO_SIDED|95.0|-41.0|5.0||||||||5|-41|
71030758|NCT02016170|141569771|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was assessed using a 95% confidence interval (CI) of the difference in mean PRU between prasugrel and ticagrelor (two arms combined).|Mean Difference (Final Values)|-11.0|||||TWO_SIDED|95.0|-18.0|-4.0||||||||-4|-18|
71030759|NCT00302952|141569772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79||||||Adjustments were made for baseline ln(CRP), baseline DAS28-CRP score, race, methotrexate use, anti-TNF use, and disease duration.|ANCOVA|||The p-value compares Lovastatin with the Placebo treatment group. Log transformed CRP was analyzed to meet the heterogeneity assumption for ANCOVA models.||||0.79
71030760|NCT00302952|141569774|SUPERIORITY_OR_OTHER_LEGACY|||||||0.91||||||Adjustments were made for baseline DAS28-CRP score.|ANCOVA|ANOVA was performed on participants with a DAS28-CRP score at Day 84.||The p-value compares Lovastatin with the Placebo treatment group.||||0.91
71030761|NCT00302952|141569775|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|-11.0||||0.39|TWO_SIDED|95.0|-35.9|14.0|||Chi-squared||The difference in percentages is calculated as Lovastatin - Placebo.|The p-value compares Lovastatin with the Placebo treatment group.||14.0|-35.9|0.39
71030762|NCT00302952|141569776|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19||||||Adjustments were made for baseline serum IgM RF by ELISA test result. In the ANCOVA model, baseline value was a covariate; therefore, an adjustment was performed.|ANCOVA|||The p-value compares Lovastatin with the Placebo treatment group.||||0.19
71030763|NCT00302952|141569777|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||||||Adjustments were made for baseline serum anti-CCP by ELISA|ANCOVA|||The p-value compares Lovastatin with the Placebo treatment group.||||0.35
71030764|NCT02597101|141569787|OTHER|REML mixed model|REML mixed model|0.05|||<|0.05|TWO_SIDED|||||Using REML mixed model analysis, differences between study arms resulting in a p\<0.05 would represent statistically-significant differences.|REML mixed model|||The primary efficacy endpoint is the improvement of insulin sensitivity by 40% or greater at 6 months compared to baseline, assessed by the hyperinsulinemic-euglycemic clamp method.||||<0.05
71030765|NCT02373098|141569797|OTHER|||||||0|||||||Wilcoxon (Mann-Whitney)|||CCL5=RANTES||||0.000
71030766|NCT02373098|141569797|OTHER|||||||0.035|||||||Wilcoxon (Mann-Whitney)|||IL17A||||0.035
71030767|NCT02373098|141569797|OTHER|||||||0.911|||||||Wilcoxon (Mann-Whitney)|||CXCL13||||0.911
71030768|NCT02373098|141569797|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||IL6||||1.000
71030769|NCT02373098|141569797|OTHER|||||||0.934|||||||Wilcoxon (Mann-Whitney)|||IL8||||0.934
71030770|NCT02373098|141569797|OTHER|||||||0.727|||||||Wilcoxon (Mann-Whitney)|||IL13||||0.727
71030771|NCT02373098|141569797|OTHER|||||||0.179|||||||Wilcoxon (Mann-Whitney)|||IL23||||0.179
71030772|NCT02373098|141569797|OTHER|||||||0.208|||||||Wilcoxon (Mann-Whitney)|||VLA4||||0.208
71030773|NCT02373098|141569797|OTHER|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||CXCL10=IP-10 (CXCR3 ligand)||||0.730
71030774|NCT02373098|141569797|OTHER|||||||0.725|||||||Wilcoxon (Mann-Whitney)|||CCL2=MCP-1||||0.725
71030775|NCT02373098|141569797|OTHER|||||||0.057|||||||Wilcoxon (Mann-Whitney)|||IL4||||0.057
71030776|NCT02373098|141569797|OTHER|||||||0.724|||||||Wilcoxon (Mann-Whitney)|||TNF alpha||||0.724
71030777|NCT02373098|141569797|OTHER|||||||0.662|||||||Wilcoxon (Mann-Whitney)|||IL22||||0.662
71030778|NCT02373098|141569798|OTHER|||||||0.256|||||||Wilcoxon (Mann-Whitney)|||CD3 abs||||0.256
71030779|NCT02373098|141569798|OTHER|||||||0.587|||||||Wilcoxon (Mann-Whitney)|||CD19 abs||||0.587
71030780|NCT02373098|141569798|OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||NK abs||||0.300
71030781|NCT02373098|141569798|OTHER|||||||0.096|||||||Wilcoxon (Mann-Whitney)|||NKT abs||||0.096
71030782|NCT02373098|141569798|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Hi CD16CD56 abs||||0.270
71030783|NCT02373098|141569798|OTHER|||||||0.902|||||||Wilcoxon (Mann-Whitney)|||CD4CD25||||0.902
71030784|NCT02373098|141569798|OTHER|||||||0.283|||||||Wilcoxon (Mann-Whitney)|||Hi CD4CD25||||0.283
71030785|NCT02373098|141569801|OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||CD3 %||||0.017
71030786|NCT02373098|141569801|OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||CD19 %||||0.300
71030787|NCT02373098|141569801|OTHER|||||||0.657|||||||Wilcoxon (Mann-Whitney)|||NK %||||0.657
71030788|NCT02373098|141569801|OTHER|||||||0.439|||||||Wilcoxon (Mann-Whitney)|||NKT %||||0.439
71030789|NCT02373098|141569801|OTHER|||||||0.449|||||||Wilcoxon (Mann-Whitney)|||Hi CD16CD56 %||||0.449
71030790|NCT02373098|141569801|OTHER|||||||0.356|||||||Wilcoxon (Mann-Whitney)|||CD3CD4||||0.356
71030791|NCT02373098|141569801|OTHER|||||||0.787|||||||Wilcoxon (Mann-Whitney)|||CD3CD8||||0.787
71030792|NCT02373098|141569801|OTHER|||||||0.121|||||||Wilcoxon (Mann-Whitney)|||CD3CD4||||0.121
71030793|NCT02373098|141569801|OTHER|||||||0.209|||||||Wilcoxon (Mann-Whitney)|||CD3CD8||||0.209
71030794|NCT02373098|141569801|OTHER|||||||0.069|||||||Wilcoxon (Mann-Whitney)|||CD4+IFNg+ (in CD4+)||||0.069
71030795|NCT02373098|141569801|OTHER|||||||0.402|||||||Wilcoxon (Mann-Whitney)|||CD4+IL17+ (in CD4+)||||0.402
71030796|NCT02373098|141569801|OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||CD8+IFNg+ (in CD8+)||||0.017
71030797|NCT02373098|141569801|OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||CD8+IL17+ (in CD8+)||||0.017
71030798|NCT02373098|141569801|OTHER|||||||0.026|||||||Wilcoxon (Mann-Whitney)|||IFNg+ (in CD4+CD25+)||||0.026
71030799|NCT02373098|141569801|OTHER|||||||0.168|||||||Wilcoxon (Mann-Whitney)|||IL17+ (in CD4+CD25+)||||0.168
71030800|NCT02373098|141569801|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||CD4+IL10+ (in CD4+)||||0.004
71030801|NCT02373098|141569801|OTHER|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||CD4+IL4+ (in CD4+)||||0.013
71030802|NCT02373098|141569801|OTHER|||||||0.171|||||||Wilcoxon (Mann-Whitney)|||CD4-CD8-IL4+ (in CD4-CD8-)||||0.171
71030803|NCT02373098|141569801|OTHER|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||CD8+IL10+ (in CD8+)||||0.013
71030804|NCT02373098|141569801|OTHER|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||CD8+IL4+ (in CD8+)||||0.013
71030805|NCT02373098|141569801|OTHER|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||IL10+ (in CD4+CD25+)||||0.007
71030806|NCT02373098|141569801|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||IL4+ (in CD4+CD25+)||||0.001
71030807|NCT02373098|141569801|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||CD4+TNFa+ (in CD4+)||||0.002
71030808|NCT02373098|141569801|OTHER|||||||0.107|||||||Wilcoxon (Mann-Whitney)|||CD4+IL9+ (in CD4+)||||0.107
71030809|NCT02373098|141569801|OTHER|||||||0|||||||Wilcoxon (Mann-Whitney)|||CD8+TNFa+ (in CD8+)||||0.000
71030810|NCT02373098|141569801|OTHER|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||CD8+IL9+ (in CD8+)||||0.022
71030811|NCT02373098|141569801|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||TNFa+ (in CD4+CD25+)||||0.001
71030812|NCT02373098|141569801|OTHER|||||||0.127|||||||Wilcoxon (Mann-Whitney)|||IL9+ (in CD4+CD25+)||||0.127
71030813|NCT04166032|141569804|OTHER|||||||0.21|||||||t-test, 2 sided|||||||0.210
71030814|NCT02008565|141569805|SUPERIORITY|||||||0.092||||||significance assessed at type 1 error alpha=0.05|Mixed Models Analysis|The models were adjusted for baseline Irritable Bowel Syndrome (IBS) status and clinical site.||||||0.092
71030815|NCT03435081|141569835|SUPERIORITY||Odds Ratio (OR)|4.6|||<|0.001|TWO_SIDED|95.0|2.31|9.15|||Regression, Logistic|||||9.15|2.31|<0.001
71030816|NCT03435081|141569836|SUPERIORITY||Odds Ratio (OR)|2.51||||0.033|TWO_SIDED|95.0|1.08|5.83|||Regression, Logistic|||||5.83|1.08|0.033
71030817|NCT03435081|141569836|SUPERIORITY||Odds Ratio (OR)|5.29|||<|0.001|TWO_SIDED|95.0|2.4|11.68|||Regression, Logistic|||||11.68|2.40|<0.001
71030818|NCT03435081|141569837|SUPERIORITY||Odds Ratio (OR)|1.71||||0.167|TWO_SIDED|95.0|0.8|3.63|||Regression, Logistic|||||3.63|0.80|0.167
71030819|NCT03435081|141569838|SUPERIORITY||Odds Ratio (OR)|2.23||||0.131|TWO_SIDED|95.0|0.79|6.31|||Regression, Logistic|||||6.31|0.79|0.131
71030820|NCT03435081|141569838|SUPERIORITY||Odds Ratio (OR)|6.73|||<|0.001|TWO_SIDED|95.0|2.63|17.19|||Regression, Logistic|||||17.19|2.63|<0.001
71030821|NCT03435081|141569839|SUPERIORITY||Mean Difference (Final Values)|-12.59|STANDARD_ERROR_OF_MEAN|7.079||0.077|TWO_SIDED|95.0|-26.54|1.36|||Mixed Models Analysis|||||1.36|-26.54|0.077
71030822|NCT03435081|141569839|SUPERIORITY||Mean Difference (Final Values)|-20.3|STANDARD_ERROR_OF_MEAN|6.875||0.004|TWO_SIDED|95.0|-33.85|-6.75|||Mixed Models Analysis|||||-6.75|-33.85|0.004
71030823|NCT03435081|141569840|SUPERIORITY||Odds Ratio (OR)|1.24||||0.733|TWO_SIDED|95.0|0.36|4.36|||Regression, Logistic|||||4.36|0.36|0.733
71030824|NCT03435081|141569840|SUPERIORITY||Odds Ratio (OR)|5.42||||0.002|TWO_SIDED|95.0|1.93|15.22|||Regression, Logistic|||||15.22|1.93|0.002
71030825|NCT03435081|141569841|SUPERIORITY||Odds Ratio (OR)|3.08||||0.012|TWO_SIDED|95.0|1.29|7.36|||Regression, Logistic|||||7.36|1.29|0.012
71030826|NCT03435081|141569841|SUPERIORITY||Odds Ratio (OR)|5.32|||<|0.001|TWO_SIDED|95.0|2.31|12.28|||Regression, Logistic|||||12.28|2.31|<0.001
71030827|NCT03435081|141569842|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.273||0.433|TWO_SIDED|95.0|-0.75|0.32|||Mixed Models Analysis|||||0.32|-0.75|0.433
71030828|NCT03435081|141569842|SUPERIORITY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.269||0.029|TWO_SIDED|95.0|-1.12|-0.06|||Mixed Models Analysis|||||-0.06|-1.12|0.029
71030829|NCT03435081|141569843|SUPERIORITY||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.441||0.012|TWO_SIDED|95.0|-1.99|-0.25|||Mixed Models Analysis|||||-0.25|-1.99|0.012
71030830|NCT03435081|141569843|SUPERIORITY||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|0.433||0.002|TWO_SIDED|95.0|-2.22|-0.51|||Mixed Models Analysis|||||-0.51|-2.22|0.002
71030831|NCT03435081|141569844|SUPERIORITY||Odds Ratio (OR)|1.69||||0.105|TWO_SIDED|95.0|0.9|3.2|||Regression, Logistic|||||3.20|0.90|0.105
71030832|NCT03435081|141569844|SUPERIORITY||Odds Ratio (OR)|3.67|||<|0.001|TWO_SIDED|95.0|2.02|6.68|||Regression, Logistic|||||6.68|2.02|<0.001
71030833|NCT03435081|141569845|SUPERIORITY||Odds Ratio (OR)|3.81||||0.144|TWO_SIDED|95.0|0.63|22.85|||Regression, Logistic|||||22.85|0.63|0.144
71030834|NCT03435081|141569845|SUPERIORITY||Odds Ratio (OR)|3.1||||0.227|TWO_SIDED|95.0|0.5|19.4|||Regression, Logistic|||||19.40|0.50|0.227
71030835|NCT03435081|141569846|SUPERIORITY||Mean Difference (Final Values)|-3.94|STANDARD_ERROR_OF_MEAN|3.921||0.316|TWO_SIDED|95.0|-11.67|3.79|||Mixed Models Analysis|||||3.79|-11.67|0.316
71030836|NCT03435081|141569846|SUPERIORITY||Mean Difference (Final Values)|-11.81|STANDARD_ERROR_OF_MEAN|3.758||0.002|TWO_SIDED|95.0|-19.23|-4.4|||Mixed Models Analysis|||||-4.40|-19.23|0.002
71030837|NCT03435081|141569847|SUPERIORITY||Odds Ratio (OR)|1.39||||0.683|TWO_SIDED|95.0|0.29|6.78|||Regression, Logistic|||||6.78|0.29|0.683
71030838|NCT03435081|141569847|SUPERIORITY||Odds Ratio (OR)|2.25||||0.277|TWO_SIDED|95.0|0.52|9.68|||Regression, Logistic|||||9.68|0.52|0.277
71030839|NCT03435081|141569848|SUPERIORITY||Mean Difference (Final Values)|-6.02|STANDARD_ERROR_OF_MEAN|2.996||0.046|TWO_SIDED|95.0|-11.93|-0.12|||Mixed Models Analysis|||||-0.12|-11.93|0.046
71030840|NCT03435081|141569848|SUPERIORITY||Mean Difference (Final Values)|-7.72|STANDARD_ERROR_OF_MEAN|2.911||0.009|TWO_SIDED|95.0|-13.46|-1.98|||Mixed Models Analysis|||||-1.98|-13.46|0.009
71030841|NCT03435081|141569849|SUPERIORITY|||||||0.598|||||||Fisher Exact|||||||0.598
71030842|NCT03435081|141569849|SUPERIORITY|||||||0.785|||||||Fisher Exact|||||||0.785
71030843|NCT03435081|141569850|SUPERIORITY||Mean Difference (Final Values)|-12.27|STANDARD_ERROR_OF_MEAN|6.562||0.063|TWO_SIDED|95.0|-25.21|0.66|||Mixed Models Analysis|||||0.66|-25.21|0.063
71030844|NCT03435081|141569850|SUPERIORITY||Mean Difference (Final Values)|-21.85|STANDARD_ERROR_OF_MEAN|6.437|<|0.001|TWO_SIDED|95.0|-34.54|-9.17|||Mixed Models Analysis|||||-9.17|-34.54|<0.001
71030845|NCT03435081|141569851|SUPERIORITY||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|1.536||0.217|TWO_SIDED|95.0|-4.93|1.12|||Mixed Models Analysis|||||1.12|-4.93|0.217
71030846|NCT03435081|141569851|SUPERIORITY||Mean Difference (Final Values)|-4.77|STANDARD_ERROR_OF_MEAN|1.487||0.002|TWO_SIDED|95.0|-7.7|-1.84|||Mixed Models Analysis|||||-1.84|-7.70|0.002
71030847|NCT03435081|141569852|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.178||0.155|TWO_SIDED|95.0|-0.6|0.1|||Mixed Models Analysis|||||0.10|-0.60|0.155
71030848|NCT03435081|141569852|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.174||0.017|TWO_SIDED|95.0|-0.76|-0.07|||Mixed Models Analysis|||||-0.07|-0.76|0.017
71030849|NCT03435081|141569853|SUPERIORITY||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|0.565||0.345|TWO_SIDED|95.0|-0.58|1.65|||Mixed Models Analysis|||Anxiety||1.65|-0.58|0.345
71030850|NCT03435081|141569853|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.543||0.336|TWO_SIDED|95.0|-1.59|0.55|||Mixed Models Analysis|||Anxiety||0.55|-1.59|0.336
71030851|NCT03435081|141569853|SUPERIORITY||Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.465||0.353|TWO_SIDED|95.0|-0.48|1.35|||Mixed Models Analysis|||Depression||1.35|-0.48|0.353
71030852|NCT03435081|141569853|SUPERIORITY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.446||0.34|TWO_SIDED|95.0|-1.31|0.45|||Mixed Models Analysis|||Depression||0.45|-1.31|0.340
71030853|NCT03435081|141569854|SUPERIORITY||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|1.228||0.224|TWO_SIDED|95.0|-3.92|0.92|||Mixed Models Analysis|||||0.92|-3.92|0.224
71030854|NCT03435081|141569854|SUPERIORITY||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|1.184||0.004|TWO_SIDED|95.0|-5.83|-1.16|||Mixed Models Analysis|||||-1.16|-5.83|0.004
71030855|NCT03435081|141569855|SUPERIORITY||Mean Difference (Final Values)|-3.36|STANDARD_ERROR_OF_MEAN|5.956||0.575|TWO_SIDED|95.0|-15.3|8.57|||Mixed Models Analysis|||Absenteeism Change from Baseline||8.57|-15.30|0.575
71030856|NCT03435081|141569855|SUPERIORITY||Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|5.664||0.851|TWO_SIDED|95.0|-12.43|10.3|||Mixed Models Analysis|||Absenteeism Change from Baseline||10.30|-12.43|0.851
71030857|NCT03435081|141569855|SUPERIORITY||Mean Difference (Final Values)|-11.75|STANDARD_ERROR_OF_MEAN|5.212||0.026|TWO_SIDED|95.0|-22.05|-1.45|||Mixed Models Analysis|||Presenteeism Change from Baseline||-1.45|-22.05|0.026
71030858|NCT03435081|141569855|SUPERIORITY||Mean Difference (Final Values)|-15.9|STANDARD_ERROR_OF_MEAN|5.056||0.002|TWO_SIDED|95.0|-25.89|-5.91|||Mixed Models Analysis|||Presenteeism Change from Baseline||-5.91|-25.89|0.002
71030859|NCT03435081|141569855|SUPERIORITY||Mean Difference (Final Values)|-12.85|STANDARD_ERROR_OF_MEAN|6.237||0.041|TWO_SIDED|95.0|-25.18|-0.51|||Mixed Models Analysis|||Overall Work Impairment Change from Baseline||-0.51|-25.18|0.041
71030860|NCT03435081|141569855|SUPERIORITY||Mean Difference (Final Values)|-16.27|STANDARD_ERROR_OF_MEAN|6.034||0.008|TWO_SIDED|95.0|-28.2|-4.34|||Mixed Models Analysis|||Overall Work Impairment Change from Baseline||-4.34|-28.20|0.008
71030861|NCT03435081|141569855|SUPERIORITY||Mean Difference (Final Values)|-9.64|STANDARD_ERROR_OF_MEAN|4.219||0.023|TWO_SIDED|95.0|-17.95|-1.32|||Mixed Models Analysis|||Activity Impairment Change from Baseline||-1.32|-17.95|0.023
71030862|NCT03435081|141569855|SUPERIORITY||Mean Difference (Final Values)|-13.29|STANDARD_ERROR_OF_MEAN|4.115||0.001|TWO_SIDED|95.0|-21.4|-5.17|||Mixed Models Analysis|||Activity Impairment Change from Baseline||-5.17|-21.40|0.001
71030863|NCT03435081|141569856|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.026||0.482|TWO_SIDED|95.0|-0.03|0.07|||Mixed Models Analysis|||Health State Index Score (US algorithm)||0.07|-0.03|0.482
71030864|NCT03435081|141569856|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.026||0.043|TWO_SIDED|95.0|0.0|0.1|||Mixed Models Analysis|||Health State Index Score (US algorithm)||0.10|0.00|0.043
71030865|NCT03435081|141569856|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.037||0.656|TWO_SIDED|95.0|-0.06|0.09|||Mixed Models Analysis|||Health State Index Score (UK algorithm)||0.09|-0.06|0.656
71030866|NCT03435081|141569856|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.036||0.057|TWO_SIDED|95.0|0.0|0.14|||Mixed Models Analysis|||Health State Index Score (UK algorithm)||0.14|-0.00|0.057
71030867|NCT03435081|141569857|SUPERIORITY||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|2.597||0.609|TWO_SIDED|95.0|-6.45|3.79|||Mixed Models Analysis|||||3.79|-6.45|0.609
71030868|NCT03435081|141569857|SUPERIORITY||Mean Difference (Final Values)|3.48|STANDARD_ERROR_OF_MEAN|2.503||0.166|TWO_SIDED|95.0|-1.46|8.41|||Mixed Models Analysis|||||8.41|-1.46|0.166
71030869|NCT03435081|141569858|SUPERIORITY||Odds Ratio (OR)|1.96||||0.258|TWO_SIDED|95.0|0.61|6.26|||Regression, Logistic|||||6.26|0.61|0.258
71030870|NCT03435081|141569858|SUPERIORITY||Odds Ratio (OR)|2.99||||0.052|TWO_SIDED|95.0|0.99|8.97|||Regression, Logistic|||||8.97|0.99|0.052
71030871|NCT00420238|141569859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.83||||0.019|TWO_SIDED|95.0|-16.5|-1.51|||ANCOVA||Least squares mean difference = mean difference final value.|Comparison of least squares means. Primary analysis: analysis of covariance (ANCOVA) with treatment as a factor and BASDAI baseline as a covariate.||-1.51|-16.5|0.019
71030872|NCT00420238|141569860|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.92||||0.098|TWO_SIDED|95.0|0.82|10.42|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors.||10.42|0.82|0.098
71030873|NCT00420238|141569860|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.02||||0.197|TWO_SIDED|95.0|0.69|5.88|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors.||5.88|0.69|0.197
71030874|NCT00420238|141569860|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3||||0.087|TWO_SIDED|95.0|0.89|5.95|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors.||5.95|0.89|0.087
71030875|NCT00420238|141569860|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.83||||0.031|TWO_SIDED|95.0|1.1|7.29|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors.||7.29|1.10|0.031
71030876|NCT00420238|141569861|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.31|TWO_SIDED|95.0|0.62|4.57|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||4.57|0.62|0.310
71030877|NCT00420238|141569861|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.309|TWO_SIDED|95.0|0.65|3.99|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||3.99|0.65|0.309
71030878|NCT00420238|141569861|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.61||||0.001|TWO_SIDED|95.0|1.81|11.74|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||11.74|1.81|0.001
71030879|NCT00420238|141569861|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.14||||0.003||95.0|1.65|10.42|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||10.42|1.65|0.003
71030880|NCT00420238|141569863|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13||||0.259|TWO_SIDED|95.0|0.57|7.94|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||7.94|0.57|0.259
71030881|NCT00420238|141569863|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.54||||0.44||95.0|0.51|4.64|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||4.64|0.51|0.440
71030882|NCT00420238|141569863|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.88||||0.046||95.0|1.02|8.16|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||8.16|1.02|0.046
71030883|NCT00420238|141569863|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.85||||0.014||95.0|1.31|11.32|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||11.32|1.31|0.014
71030884|NCT00420238|141569865|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.01||||0.204|TWO_SIDED|95.0|0.55|16.53|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||16.53|0.55|0.204
71030885|NCT00420238|141569865|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.48||||0.073||95.0|0.87|23.07|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||23.07|0.87|0.073
71030886|NCT00420238|141569865|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.73||||0.121||95.0|0.71|19.69|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||19.69|0.71|0.121
71030887|NCT00420238|141569865|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.36||||0.058||95.0|0.96|11.8|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||11.80|0.96|0.058
71153650|NCT03530124|141799877|OTHER|Average duration of apnea episodes between groups were compared using a mixed effects model with a random intercept for each infant with one or more events and study site and gestational age group as covariates to control for the randomization blocks.||||||0.36|||||||Mixed Effects Model|No adjustments were made to the alpha level (two-sided alpha=0.05) for the secondary objectives.||||||0.36
71030888|NCT00420238|141569867|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.5||||0.287|TWO_SIDED|95.0|0.35|35.14|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||35.14|0.35|0.287
71030889|NCT00420238|141569867|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.8||||0.169||95.0|0.51|44.94|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||44.94|0.51|0.169
71030890|NCT00420238|141569867|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.48||||0.073||95.0|0.87|23.07|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||23.07|0.87|0.073
71030891|NCT00420238|141569867|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.48||||0.073||95.0|0.87|23.07|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||23.07|0.87|0.073
71030892|NCT00420238|141569869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.95||||0.018|TWO_SIDED|95.0|-18.19|-1.72|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||-1.72|-18.19|0.018
71030893|NCT00420238|141569870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.54||||0.089|TWO_SIDED|95.0|-18.4|1.33|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||1.33|-18.40|0.089
71030894|NCT00420238|141569870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.02||||0.11||95.0|-17.89|1.85|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interactions as fixed factors, baseline value as a covariate, and patients as a random factor.||1.85|-17.89|0.110
71030895|NCT00420238|141569870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.73||||0.004||95.0|-24.6|-4.86|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interactions as fixed factors, baseline value as a covariate, and patients as a random factor.||-4.86|-24.60|0.004
71030896|NCT00420238|141569870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.27||||0.065||95.0|-19.14|0.59|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interactions as fixed factors, baseline value as a covariate, and patients as a random factor.||0.59|-19.14|0.065
71030897|NCT00420238|141569872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.99||||0.002|TWO_SIDED|95.0|-17.7|-4.28|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||-4.28|-17.70|0.002
71030898|NCT00420238|141569873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.33||||0.054|TWO_SIDED|95.0|-16.81|0.15|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||0.15|-16.81|0.054
71030899|NCT00420238|141569873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.02||||0.011||95.0|-19.5|-2.54|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-2.54|-19.50|0.011
71030900|NCT00420238|141569873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.75||||0.003||95.0|-21.23|-4.27|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-4.27|-21.23|0.003
71030901|NCT00420238|141569873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.29|||<|0.001||95.0|-23.7|-6.82|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-6.82|-23.7|<0.001
71030902|NCT00420238|141569875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.59||||0.039|TWO_SIDED|95.0|-18.69|-0.49|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||-0.49|-18.69|0.039
71030903|NCT00420238|141569876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.28||||0.254|TWO_SIDED|95.0|-17.13|4.57|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||4.57|-17.13|0.254
71030904|NCT00420238|141569876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.17||||0.348||95.0|-16.02|5.68|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||5.68|-16.02|0.348
71030905|NCT00420238|141569876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.72||||0.014||95.0|-24.57|-2.88|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-2.88|-24.57|0.014
71030906|NCT00420238|141569876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.69|||<|0.001||95.0|-30.54|-8.84|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-8.84|-30.54|<0.001
71030907|NCT00420238|141569878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.49||||0.071|TWO_SIDED|95.0|-17.73|0.75|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||0.75|-17.73|0.071
71030908|NCT00420238|141569879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.57||||0.511|TWO_SIDED|95.0|-14.31|7.17|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||7.17|-14.31|0.511
71030909|NCT00420238|141569879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.57||||0.401||95.0|-15.31|6.17|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||6.17|-15.31|0.401
71030910|NCT00420238|141569879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.45||||0.023||95.0|-23.19|-1.71|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-1.71|-23.19|0.023
71030911|NCT00420238|141569879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.25||||0.01||95.0|-24.99|-3.51|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-3.51|-24.99|0.010
71030912|NCT00420238|141569881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.25||||0.127|TWO_SIDED|95.0|-12.03|1.53|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline as a covariate.||1.53|-12.03|0.127
71030913|NCT00420238|141569882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.914|TWO_SIDED|95.0|-8.23|7.38|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||7.38|-8.23|0.914
71030914|NCT00420238|141569882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.544||95.0|-10.21|5.41|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||5.41|-10.21|0.544
71030915|NCT00420238|141569882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.21||||0.039||95.0|-16.02|-0.4|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-0.40|-16.02|0.039
71092004|NCT01155323|141690593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.21|0.23|||Mixed Models Analysis||Mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be superior to omafilcon A for comfort.||0.23|-0.21|
71030916|NCT00420238|141569882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.54||||0.004||95.0|-19.35|-3.73|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-3.73|-19.35|0.004
71030917|NCT00420238|141569885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.86||||0.122|TWO_SIDED|95.0|-15.57|1.85|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||1.85|-15.57|0.122
71030918|NCT00420238|141569885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.45||||0.145||95.0|-15.16|2.26|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||2.26|-15.16|0.145
71030919|NCT00420238|141569885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.55||||0.005||95.0|-21.26|-3.84|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-3.84|-21.26|0.005
71092005|NCT01155323|141690594|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.50|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.19|0.25|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be non-inferior to omafilcon A for vision.||0.25|-0.19|
71030920|NCT00420238|141569885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.95||||0.008||95.0|-20.66|-3.24|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-3.24|-20.66|0.008
71030921|NCT00420238|141569889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.94||||0.139|TWO_SIDED|95.0|-13.84|1.96|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||1.96|-13.84|0.139
71030922|NCT00420238|141569890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.857|TWO_SIDED|95.0|-8.88|10.67|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||10.67|-8.88|0.857
71030923|NCT00420238|141569890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1||||0.304||95.0|-14.88|4.67|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||4.67|-14.88|0.304
71030924|NCT00420238|141569890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.9||||0.047||95.0|-19.68|-0.13|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-0.13|-19.68|0.047
71030925|NCT00420238|141569890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.65||||0.007||95.0|-23.43|-3.88|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-3.88|-23.43|0.007
71030926|NCT00420238|141569893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.003|TWO_SIDED|95.0|0.06|0.31|||ANCOVA||Least squares mean difference = mean difference final value.|Vital Capacity: Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||0.31|0.06|0.003
71030927|NCT00420238|141569893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.006|TWO_SIDED|95.0|0.05|0.31|||ANCOVA||Least squares mean difference = mean difference final value.|Forced Vital Capacity: Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||0.31|0.05|0.006
71030928|NCT00420238|141569893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.205|TWO_SIDED|95.0|-0.04|0.17|||ANCOVA||Least squares mean difference = mean difference final value.|Forced Expitatory Volume in 1 second: Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||0.17|-0.04|0.205
71030929|NCT00420238|141569894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.59||||0.03|TWO_SIDED|95.0|-4.93|-0.26|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis oaf covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||-0.26|-4.93|0.030
71030930|NCT00420238|141569895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.035|TWO_SIDED|95.0|-0.45|-0.02|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as covariate.||-0.02|-0.45|0.035
71030931|NCT00420238|141569896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.515|TWO_SIDED|95.0|-0.38|0.19|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||0.19|-0.38|0.515
71030932|NCT00420238|141569896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.316||95.0|-0.43|0.14|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||0.14|-0.43|0.316
71030933|NCT00420238|141569896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.008||95.0|-0.67|-0.1|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||-0.10|-0.67|0.008
71030934|NCT00420238|141569896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.011||95.0|-0.65|-0.08|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||-0.08|-0.65|0.011
71030935|NCT00420238|141569908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.613|TWO_SIDED|95.0|-0.22|0.37|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||0.37|-0.22|0.613
71030936|NCT00420238|141569909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.744|TWO_SIDED|95.0|-0.34|0.47|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||0.47|-0.34|0.744
71030937|NCT00420238|141569909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.625||95.0|-0.5|0.3|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||0.30|-0.50|0.625
70970468|NCT02706873|141446956|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|31.5|||<|0.001|TWO_SIDED|95.0|24.5|38.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||38.5|24.5|<0.001
70970469|NCT02706873|141446957|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|21.6|||<|0.001|TWO_SIDED|95.0|14.3|28.8||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||28.8|14.3|<0.001
70970470|NCT02706873|141446957|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|22.9|||<|0.001|TWO_SIDED|95.0|15.7|30.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||30.1|15.7|<0.001
70970471|NCT02706873|141446958|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Least Squares (LS) Mean Difference|-0.53||||0.001|TWO_SIDED|95.0|-0.85|-0.2||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|Analysis of covariance (ANCOVA) model with treatment, geographic region as fixed factors and baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||-0.20|-0.85|0.001
70970472|NCT02706873|141446958|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|LS Mean Difference|-0.59|||<|0.001|TWO_SIDED|95.0|-0.91|-0.27||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||-0.27|-0.91|<0.001
70970473|NCT02706873|141446959|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|-0.88|||<|0.001|TWO_SIDED|95.0|-1.09|-0.67||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.||||-0.67|-1.09|<0.001
70970474|NCT02706873|141446959|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|-1.01|||<|0.001|TWO_SIDED|95.0|-1.21|-0.8||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.80|-1.21|<0.001
70970475|NCT02706873|141446960|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|-0.34|||<|0.001|TWO_SIDED|95.0|-0.44|-0.25||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.25|-0.44|<0.001
70970476|NCT02706873|141446960|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|-0.37|||<|0.001|TWO_SIDED|95.0|-0.47|-0.28||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.28|-0.47|<0.001
71030938|NCT00420238|141569909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.325||95.0|-0.2|0.6|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||0.60|-0.20|0.325
71030939|NCT00420238|141569909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.76||95.0|-0.34|0.46|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||0.46|-0.34|0.760
71030940|NCT00420238|141569911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.72||||0.49|TWO_SIDED|95.0|-18.35|8.91|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||8.91|-18.35|0.490
71030941|NCT00420238|141569911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.09||||0.651||95.0|-16.73|10.54|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||10.54|-16.73|0.651
71030942|NCT00420238|141569911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39||||0.84||95.0|-15.12|12.34|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||12.34|-15.12|0.840
71030943|NCT00420238|141569911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.02||||0.562||95.0|-17.81|9.77|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||9.77|-17.81|0.562
71030944|NCT00420238|141569913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.73|||<|0.0001|TWO_SIDED|95.0|-19.44|-10.03|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA)with treatment as a factor and baseline vlue as a covariate.||-10.03|-19.44|<0.0001
71030945|NCT00420238|141569914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.37|||<|0.0001|TWO_SIDED|95.0|-18.17|-6.58|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and atients as a random factor.||-6.58|-18.17|<0.0001
71030946|NCT00420238|141569914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.45|||<|0.0001||95.0|-23.25|-11.65|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||-11.65|-23.25|<0.0001
71030947|NCT00420238|141569914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.95|||<|0.0001||95.0|-22.75|-11.15|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||-11.15|-22.75|<0.0001
71030948|NCT00420238|141569914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.16|||<|0.0001||95.0|-23.96|-12.36|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||-12.36|-23.96|<0.0001
71030949|NCT00420238|141569916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.24|||<|0.0001|TWO_SIDED|95.0|-18.23|-8.25|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA), with treatment as a factor and baseline value as a covariate.||-8.25|-18.23|<0.0001
71030950|NCT00420238|141569917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.32|||<|0.0001|TWO_SIDED|95.0|-20.55|-8.1|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors, baseline as a covariate and patients as a random factor.||-8.10|-20.55|<0.0001
71030951|NCT00420238|141569917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.98|||<|0.0001||95.0|-21.2|-8.76|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors, baseline as a covariate and patients as a random factor.||-8.76|-21.20|<0.0001
71030952|NCT00420238|141569917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.19|||<|0.0001||95.0|-21.41|-8.96|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors, baseline as a covariate and patients as a random factor.||-8.96|-21.41|<0.0001
71030953|NCT00420238|141569917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.41|||<|0.0001||95.0|-20.63|-8.19|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors, baseline as a covariate and patients as a random factor.||-8.19|-20.63|<0.0001
71030954|NCT00420238|141569920|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87||||0.184|TWO_SIDED|95.0|0.74|4.7|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 2: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||4.70|0.74|0.184
71030955|NCT00420238|141569920|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.62||||0.036||95.0|1.06|6.46|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 4: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||6.46|1.06|0.036
71030956|NCT00420238|141569920|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.96||||0.001||95.0|1.89|13.03|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 8: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||13.03|1.89|0.001
71030957|NCT00420238|141569920|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38||||0.065||95.0|0.95|5.96|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 12: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||5.96|0.95|0.065
71030958|NCT00420238|141569922|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.57||||0.004|TWO_SIDED|95.0|1.64|12.74|||GEE model||Odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 2: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||12.74|1.64|0.004
71030959|NCT00420238|141569922|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.46||||0.054||95.0|0.99|6.12|||GEE model||Odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 4: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||6.12|0.99|0.054
71030960|NCT00420238|141569922|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.26|||<|0.001||95.0|2.27|17.31|||GEE model||Odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 8: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||17.31|2.27|<0.001
71030961|NCT00420238|141569922|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.88||||0.025||95.0|1.14|7.27|||GEE model||Odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 12: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||7.27|1.14|0.025
71030962|NCT04320849|141570001|OTHER||Slope|0.0675|||||ONE_SIDED|90.0||0.106||||||"The following set of hypotheses were used to evaluate the relationship between lead stiffness and curvature in the extravenous region:~H0: a ≥ 0 Ha: a \< 0 where a represents the coefficient for stiffness in the following model: log (curvature) = a\*stiffness + b + normally distributed error."||0.106||
71030963|NCT04320849|141570002|OTHER||Slope|0.199|||||ONE_SIDED|90.0||0.397||||||"The following set of hypotheses will be used to evaluate the relationship between lead stiffness and curvature in the intracardiac region:~H0: a ≥ 0 Ha: a \< 0 where a represents the coefficient for stiffness in the following model: log (curvature) = a\*stiffness + b + normally distributed error."||0.397||
71030964|NCT04320849|141570003|OTHER||Slope|-0.015|||||ONE_SIDED|90.0||0.0123||||||"The following set of hypotheses were used to evaluate the relationship between lead stiffness and curvature in the connector region:~H0: a ≥ 0 Ha: a \< 0 where a represents the coefficient for stiffness in the following model: log (curvature) = a\*stiffness + b + normally distributed error."||0.0123||
70909374|NCT02886728|141307201|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.4||0.029|TWO_SIDED|95.0|-6.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-6.0|0.029
71008712|NCT02055976|141525246|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.462|STANDARD_ERROR_OF_MEAN|1.434|<|0.001|TWO_SIDED|95.0|-10.311|-4.614|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-4.614|-10.311|<0.001
71030965|NCT03018249|141570011|SUPERIORITY|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
71030966|NCT03018249|141570012|SUPERIORITY||Mean Difference (Final Values)|2.7|||||TWO_SIDED|95.0|-25.0|30.0||||||||30|-25|
71030967|NCT03018249|141570013|SUPERIORITY||Mean Difference (Final Values)|21.8|||||TWO_SIDED|95.0|-16.7|45.3||||||||45.3|-16.7|
71030968|NCT03966365|141570043|OTHER|||||||0.706|||||||Wilcoxon (Mann-Whitney)|||||||0.706
71030969|NCT03966365|141570044|OTHER|||||||0.622|||||||Wilcoxon (Mann-Whitney)|||||||0.622
71030970|NCT03966365|141570045|OTHER|||||||0.081|||||||Chi-squared, Corrected|||Green lissamine treatment groups||||0.081
71030971|NCT03966365|141570045|OTHER|||||||0.49|||||||Chi-squared, Corrected|||Fluorescein treatment groups||||0.490
71030972|NCT03966365|141570046|OTHER|||||||0.253|||||||Wilcoxon (Mann-Whitney)|||||||0.253
71030973|NCT03966365|141570047|OTHER|||||||0.031|||||||Chi-squared, Corrected|||||||0.031
71030974|NCT03966365|141570049|OTHER|||||||0.651|||||||Wilcoxon (Mann-Whitney)|||||||0.651
71030975|NCT01523899|141570052|SUPERIORITY||Mean Difference (Final Values)|0.145|||||TWO_SIDED|95.0||||Pearson chi squared, Fisher exact, 2 sample t-tests||||||||
71030976|NCT01523899|141570053|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||>0.05
71030977|NCT00824265|141570055|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.67||||0.0032|TWO_SIDED|95.0|0.51|0.88|||Log Rank|||||0.88|0.51|0.0032
71030978|NCT00824265|141570056|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8||||0.1427|TWO_SIDED|95.0|0.59|1.09|||Log Rank|||||1.09|0.59|0.1427
71030979|NCT00824265|141570057|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.08||||0.449|TWO_SIDED|95.0|0.85|1.37|||Log Rank|||||1.37|0.85|0.4490
71030980|NCT00824265|141570058|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.0878|TWO_SIDED|95.0|0.56|1.05|||Log Rank|||||1.05|0.56|0.0878
71030981|NCT00824265|141570059|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.0036|TWO_SIDED|95.0|0.45|0.87|||Log Rank|||||0.87|0.45|0.0036
71030982|NCT00824265|141570060|SUPERIORITY_OR_OTHER_LEGACY|Participants in the ITT population|Hazard Ratio (HR)|0.77||||0.1143|TWO_SIDED|95.0|0.55|1.08|||Log Rank|||||1.08|0.55|0.1143
71030983|NCT00824265|141570060|SUPERIORITY_OR_OTHER_LEGACY|Participants who took anti-cancer therapies|Hazard Ratio (HR)|0.67||||0.0109|TWO_SIDED|95.0|0.48|0.94|||Log Rank|||||0.94|0.48|0.0109
71030984|NCT00824265|141570063|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||Cochran-Mantel-Haenszel|||||||0.0003
71030985|NCT00824265|141570064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0166|||||||Cochran-Mantel-Haenszel|||||||0.0166
71030986|NCT01402947|141570084|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean Ratio|1.013|||||TWO_SIDED|90.0|0.933|1.1|||ANOVA|||||1.100|0.933|
71030987|NCT01402947|141570085|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean Ratio|0.999|||||TWO_SIDED|90.0|0.893|1.117|||ANOVA|||||1.117|0.893|
71030988|NCT01108094|141570088|OTHER|||||||0.04|||||||t-test, 2 sided|||"Percent change in Ki67 tumor proliferation biomarker from baseline to 1 month, for Cohort A1 (vismodegib-naive patients, n = 8).~Paired analysis of tumors shows percent change between baseline (prior to treatment) and post-itraconazole treatment in individual patients.~% change was calculated from the difference between the mean of baseline Ki67 levels and the mean Ki67 levels after 1 month of treatment."||||0.04
71030989|NCT01108094|141570088|OTHER|||||||0.079|||||||t-test, 1 sided|||"Percent change in Ki67 tumor proliferation biomarker - baseline vs 1 month - Cohort A, vismodegib-naive (n = 8) vs control patients Unpaired analysis shows percent change between individual tumors from control patients and itraconazole treated patients.~% change was calculated from the difference between the mean of baseline Ki67 levels and the mean Ki67 levels after 1 month of treatment."||||0.079
71030990|NCT01108094|141570088|OTHER|||||||0.652|||||||t-test, 2 sided|||"Percent change in Ki67 tumor proliferation biomarker - baseline vs 1 month - control patients Paired analysis of tumors shows percent change between baseline and after 1 month in individual patients.~% change was calculated from the difference between the mean of baseline Ki67 levels and the mean Ki67 levels after 1 month."||||0.652
71030991|NCT01108094|141570089|OTHER|||||||0.028|||||||t-test, 2 sided|||"Percentage change in GLI1 messenger RNA (mRNA) expression Paired analysis of tumors shows percent change between baseline (prior to treatment) and post itraconazole treatment in individual patients.~% change was calculated from the difference between the mean of baseline Gli levels and the mean Gli level after 1 month of treatment."|Wilcoxon signed rank test|||0.028
71030992|NCT01108094|141570090|OTHER||Mean Difference (Final Values)|24.0|||||TWO_SIDED|95.0|18.2|30.0||||||Only tumors from 4 patients from cohort A (n = 42 BCCs) and all tumors from the 4 patients (n = 14 BCCs) in cohort B were observed for tumor size change. Percent change in tumor area from both cohorts (eight patients total with 57 tumors) was calculated only.||30|18.2|
71030993|NCT01108094|141570090|OTHER|||||||0.435|||||||t-test, 1 sided|||Average tumor size reductions were compared between Cohort A1 and Cohort B.||||0.435
71030994|NCT04349917|141570092|SUPERIORITY|||||||0.532|||||||t-test, 2 sided|||||||0.532
71008713|NCT02055976|141525246|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.693|STANDARD_ERROR_OF_MEAN|1.469|<|0.001|TWO_SIDED|95.0|-9.61|-3.776|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-3.776|-9.610|<0.001
71030995|NCT04349917|141570093|SUPERIORITY|||||||0.579|||||||t-test, 2 sided|||Analysis for GNG regular task||||0.579
71030996|NCT04349917|141570093|SUPERIORITY|||||||0.034|||||||t-test, 2 sided|||Analysis for GNG reward task||||0.034
71030997|NCT04349917|141570094|SUPERIORITY|||||||0.296|||||||t-test, 2 sided|||Analysis for reconfiguration between rest and GNG regular task||||0.296
71030998|NCT04349917|141570094|SUPERIORITY|||||||0.169|||||||t-test, 2 sided|||Analysis for reconfiguration between rest and GNG reward task||||0.169
71030999|NCT04349917|141570095|SUPERIORITY|||||||0.118|||||||Pearson correlation|||Change in rest modularity vs change in GNG regular commission rate||||0.118
71031000|NCT04349917|141570095|SUPERIORITY|||||||0.022|||||||Pearson correlation|||Change in rest modularity vs change in GNG regular omission rate||||0.022
71031001|NCT04349917|141570095|SUPERIORITY|||||||0.22|||||||Pearson correlation|||Change in rest modularity vs Change in GNG regular RT Variability||||0.220
71031002|NCT04349917|141570095|SUPERIORITY|||||||0.496|||||||Pearson correlation|||Change in rest modularity vs change in GNG reward commission rate||||0.496
71031003|NCT04349917|141570095|SUPERIORITY|||||||0.343|||||||Pearson correlation|||Change in rest modularity vs change in GNG reward omission rate||||0.343
71031004|NCT04349917|141570095|SUPERIORITY|||||||0.988|||||||Pearson correlation|||Change in rest modularity vs change in GNG reward RT variability||||0.988
71031005|NCT04349917|141570095|SUPERIORITY|||||||0.892|||||||Pearson correlation|||Change in GNG regular modularity vs change in GNG regular commission rate||||0.892
71031006|NCT04349917|141570095|SUPERIORITY|||||||0.473|||||||Pearson correlation|||Change in GNG regular modularity vs change in GNG regular omission rate||||0.473
71031007|NCT04349917|141570095|SUPERIORITY|||||||0.409|||||||Pearson correlation|||Change in GNG regular modularity vs Change in GNG regular RT Variability||||0.409
71031008|NCT04349917|141570095|SUPERIORITY|||||||0.351|||||||Pearson correlation|||Change in GNG reward modularity vs change in GNG reward commission rate||||0.351
71031009|NCT04349917|141570095|SUPERIORITY|||||||0.238|||||||Pearson correlation|||Change in GNG reward modularity vs change in GNG reward omission rate||||0.238
71031010|NCT04349917|141570095|SUPERIORITY|||||||0.909|||||||Pearson correlation|||Change in GNG reward modularity vs Change in GNG reward RT Variability||||0.909
71031011|NCT04349917|141570096|SUPERIORITY|||||||0.806|||||||t-test, 2 sided|||Analysis for GNG regular task||||0.806
71031012|NCT04349917|141570096|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||Analysis for GNG reward task||||0.003
71031013|NCT04349917|141570097|SUPERIORITY|||||||0.093|||||||t-test, 2 sided|||Analysis for GNG regular task||||0.093
71031014|NCT04349917|141570097|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||Analysis for GNG reward task||||0.0001
71031015|NCT04349917|141570098|SUPERIORITY|||||||0.075|||||||t-test, 2 sided|||Analysis for GNG regular task||||0.075
71031016|NCT04349917|141570098|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||Analysis for GNG reward task||||0.0001
71031017|NCT00705536|141570099|SUPERIORITY_OR_OTHER|||||||0.0006||||||Treatment comparison of Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0006
71031018|NCT00705536|141570099|SUPERIORITY_OR_OTHER|||||||0.0002||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0002
71031019|NCT00705536|141570100|SUPERIORITY_OR_OTHER|||||||0.0003||||||Treatment comparison of Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0003
71031020|NCT00705536|141570100|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||<0.0001
71031021|NCT00705536|141570101|SUPERIORITY_OR_OTHER|||||||0.0059||||||Treatment comparison of Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0059
71031022|NCT00705536|141570101|SUPERIORITY_OR_OTHER|||||||0.0105||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0105
71031023|NCT00705536|141570102|SUPERIORITY_OR_OTHER|||||||0.0002||||||Treatment comparison for Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0002
71031024|NCT00705536|141570102|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||<0.0001
71031025|NCT00705536|141570103|SUPERIORITY_OR_OTHER|||||||0.3019||||||Treatment comparison for Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.3019
71031026|NCT00705536|141570104|SUPERIORITY_OR_OTHER|||||||0.0401||||||Treatment comparison of Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0401
71031027|NCT00705536|141570104|SUPERIORITY_OR_OTHER|||||||0.0004||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0004
71031028|NCT00705536|141570105|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog alone and Humalog +rHuPH20 using a pairwise t-test.|ANOVA|||||||<0.0001
71031029|NCT00705536|141570105|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||<0.0001
71031030|NCT00705536|141570107|SUPERIORITY_OR_OTHER|||||||0.5589||||||Treatment comparison of Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.5589
71031031|NCT00705536|141570107|SUPERIORITY_OR_OTHER|||||||0.0067||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0067
71031032|NCT02289963|141570121|SUPERIORITY||Least Square (LS) Mean Difference|-63.4|||<|0.0001|TWO_SIDED|95.0|-71.6|-55.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/ Up to 150 mg Q2W vs. Placebo Q2W|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-55.2|-71.6|<0.0001
71031033|NCT02289963|141570122|SUPERIORITY||LS Mean Difference|-66.2|||<|0.0001|TWO_SIDED|95.0|-73.9|-58.4||Threshold for significance was at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-58.4|-73.9|<0.0001
71031034|NCT02289963|141570123|SUPERIORITY||LS Mean Difference|-62.5|||<|0.0001|TWO_SIDED|95.0|-68.8|-56.3||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-56.3|-68.8|<0.0001
71031035|NCT02289963|141570124|SUPERIORITY||LS Mean Difference|-63.1|||<|0.0001|TWO_SIDED|95.0|-69.2|-57.0||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-57.0|-69.2|<0.0001
71031036|NCT02289963|141570125|SUPERIORITY||LS Mean Difference|-46.3|||<|0.0001|TWO_SIDED|95.0|-53.0|-39.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-39.7|-53.0|<0.0001
71031037|NCT02289963|141570126|SUPERIORITY||LS Mean Difference|-49.2|||<|0.0001|TWO_SIDED|95.0|-55.3|-43.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-43.1|-55.3|<0.0001
71031038|NCT02289963|141570127|SUPERIORITY||LS Mean Difference|-51.5|||<|0.0001|TWO_SIDED|95.0|-58.4|-44.6||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-44.6|-58.4|<0.0001
71031039|NCT02289963|141570128|SUPERIORITY||LS Mean Difference|-54.2|||<|0.0001|TWO_SIDED|95.0|-60.6|-47.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-47.8|-60.6|<0.0001
71031040|NCT02289963|141570129|SUPERIORITY||LS Mean Difference|-35.2|||<|0.0001|TWO_SIDED|95.0|-40.3|-30.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-30.1|-40.3|<0.0001
71031041|NCT02289963|141570130|SUPERIORITY||LS Mean Difference|-46.1|||<|0.0001|TWO_SIDED|95.0|-51.2|-41.0||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-41.0|-51.2|<0.0001
71031042|NCT02289963|141570131|SUPERIORITY||LS Mean Difference|-51.2|||<|0.0001|TWO_SIDED|95.0|-56.4|-46.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-46.1|-56.4|<0.0001
71031043|NCT02289963|141570132|SUPERIORITY||LS Mean Difference|-35.8|||<|0.0001|TWO_SIDED|95.0|-39.7|-31.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant.||-31.9|-39.7|<0.0001
70909375|NCT02886728|141307201|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.4||0.01|TWO_SIDED|95.0|-6.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-6.0|0.010
70909376|NCT02886728|141307202|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|95.0|-15.0|-9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-9.0|-15.0|<0.001
70909377|NCT02886728|141307202|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-11.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-11.0|<0.001
70909378|NCT02886728|141307202|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-13.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-13.0|<0.001
70909379|NCT02886728|141307202|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-16.0|-10.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-10.0|-16.0|<0.001
70909380|NCT02886728|141307202|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.9|<|0.001|TWO_SIDED|95.0|-11.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-11.0|<0.001
70909381|NCT02886728|141307202|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.9|<|0.001|TWO_SIDED|95.0|-13.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-13.0|<0.001
70909382|NCT02886728|141307202|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-15.0|-8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.0|-15.0|<0.001
70909383|NCT02886728|141307202|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|2.1||0.019|TWO_SIDED|95.0|-9.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-9.0|0.019
70909384|NCT02886728|141307202|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|2.1||0.007|TWO_SIDED|95.0|-10.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-10.0|0.007
71031044|NCT02289963|141570133|SUPERIORITY||Odds Ratio (OR)|46.9|||<|0.0001|TWO_SIDED|95.0|18.4|119.4||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||119.4|18.4|<0.0001
70909385|NCT02886728|141307202|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-12.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-12.0|<0.001
71031045|NCT02289963|141570134|SUPERIORITY||Odds Ratio (OR)|70.0|||<|0.0001|TWO_SIDED|95.0|23.3|210.8||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model|Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||210.8|23.3|<0.0001
70909386|NCT02886728|141307202|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|2.0||0.13|TWO_SIDED|95.0|-7.0|1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.0|-7.0|0.13
70909387|NCT02886728|141307202|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|2.0||0.047|TWO_SIDED|95.0|-8.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-8.0|0.047
70909388|NCT02886728|141307202|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.8|<|0.001|TWO_SIDED|95.0|-11.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-11.0|<0.001
70909389|NCT02886728|141307202|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.1||0.34|TWO_SIDED|95.0|-6.0|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-6.0|0.34
70909390|NCT02886728|141307202|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.1||0.46|TWO_SIDED|95.0|-6.0|3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.0|-6.0|0.46
70909391|NCT02886728|141307202|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.8|<|0.001|TWO_SIDED|95.0|-12.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-12.0|<0.001
70909392|NCT02886728|141307202|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|2.2||0.03|TWO_SIDED|95.0|-9.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-9.0|0.030
70909393|NCT02886728|141307202|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|2.2|<|0.001|TWO_SIDED|95.0|-12.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-12.0|<0.001
70909394|NCT02886728|141307203|SUPERIORITY||Least Squares Mean Difference|-10.78|STANDARD_ERROR_OF_MEAN|0.983|<|0.001|TWO_SIDED|95.0|-12.71|-8.85||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.85|-12.71|<0.001
70909395|NCT02886728|141307203|SUPERIORITY||Least Squares Mean Difference|-8.76|STANDARD_ERROR_OF_MEAN|1.207|<|0.001|TWO_SIDED|95.0|-11.13|-6.39||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.39|-11.13|<0.001
70909396|NCT02886728|141307203|SUPERIORITY||Least Squares Mean Difference|-9.64|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-12.0|-7.29||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.29|-12.00|<0.001
70909397|NCT02886728|141307203|SUPERIORITY||Least Squares Mean Difference|-9.92|STANDARD_ERROR_OF_MEAN|0.884|<|0.001|TWO_SIDED|95.0|-11.65|-8.19||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.19|-11.65|<0.001
71031046|NCT02289963|141570135|SUPERIORITY||Adjusted Mean Difference|-33.611|||<|0.0001|TWO_SIDED|95.0|-41.883|-25.338||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-25.338|-41.883|<0.0001
70909398|NCT02886728|141307203|SUPERIORITY||Least Squares Mean Difference|-8.34|STANDARD_ERROR_OF_MEAN|1.086|<|0.001|TWO_SIDED|95.0|-10.47|-6.21||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.21|-10.47|<0.001
70909399|NCT02886728|141307203|SUPERIORITY||Least Squares Mean Difference|-7.33|STANDARD_ERROR_OF_MEAN|1.08|<|0.001|TWO_SIDED|95.0|-9.45|-5.21||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.21|-9.45|<0.001
70909400|NCT02886728|141307203|SUPERIORITY||Least Squares Mean Difference|-5.98|STANDARD_ERROR_OF_MEAN|0.808|<|0.001|TWO_SIDED|95.0|-7.56|-4.39||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.39|-7.56|<0.001
70909401|NCT02886728|141307203|SUPERIORITY||Least Squares Mean Difference|-4.21|STANDARD_ERROR_OF_MEAN|0.987|<|0.001|TWO_SIDED|95.0|-6.14|-2.27||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.27|-6.14|<0.001
70909402|NCT02886728|141307203|SUPERIORITY||Least Squares Mean Difference|-4.34|STANDARD_ERROR_OF_MEAN|0.993|<|0.001|TWO_SIDED|95.0|-6.29|-2.39||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.39|-6.29|<0.001
70909403|NCT02886728|141307203|SUPERIORITY||Least Squares Mean Difference|-5.27|STANDARD_ERROR_OF_MEAN|1.003|<|0.001|TWO_SIDED|95.0|-7.24|-3.31||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.31|-7.24|<0.001
70909404|NCT02886728|141307203|SUPERIORITY||Least Squares Mean Difference|-3.29|STANDARD_ERROR_OF_MEAN|1.222||0.007|TWO_SIDED|95.0|-5.68|-0.89||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.89|-5.68|0.007
70909405|NCT02886728|141307203|SUPERIORITY||Least Squares Mean Difference|-4.61|STANDARD_ERROR_OF_MEAN|1.229|<|0.001|TWO_SIDED|95.0|-7.02|-2.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.20|-7.02|<0.001
70909406|NCT02886728|141307203|SUPERIORITY||Least Squares Mean Difference|-3.44|STANDARD_ERROR_OF_MEAN|0.974|<|0.001|TWO_SIDED|95.0|-5.35|-1.53||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.53|-5.35|<0.001
70909407|NCT02886728|141307203|SUPERIORITY||Least Squares Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.18||0.004|TWO_SIDED|95.0|-5.72|-1.09||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.09|-5.72|0.004
70909408|NCT02886728|141307203|SUPERIORITY||Least Squares Mean Difference|-2.12|STANDARD_ERROR_OF_MEAN|1.18||0.072|TWO_SIDED|95.0|-4.44|0.19||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.19|-4.44|0.072
71031047|NCT02289963|141570136|SUPERIORITY||LS Mean Difference|7.5||||0.0029|TWO_SIDED|95.0|2.6|12.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||12.4|2.6|0.0029
71031048|NCT02289963|141570137|SUPERIORITY||LS Mean Difference|-4.515||||0.311|TWO_SIDED|95.0|-13.25|4.219||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||4.219|-13.250|0.3110
71031049|NCT00549718|141570190|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
71031050|NCT00549718|141570191|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
70909409|NCT02886728|141307203|SUPERIORITY||Least Squares Mean Difference|-4.79|STANDARD_ERROR_OF_MEAN|0.789|<|0.001|TWO_SIDED|95.0|-6.34|-3.24||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.24|-6.34|<0.001
70909410|NCT02886728|141307203|SUPERIORITY||Least Squares Mean Difference|-3.01|STANDARD_ERROR_OF_MEAN|0.957||0.002|TWO_SIDED|95.0|-4.88|-1.13||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.13|-4.88|0.002
70909411|NCT02886728|141307203|SUPERIORITY||Least Squares Mean Difference|-3.77|STANDARD_ERROR_OF_MEAN|0.957|<|0.001|TWO_SIDED|95.0|-5.65|-1.89||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.89|-5.65|<0.001
70909412|NCT02886728|141307204|SUPERIORITY||Difference in Response Rates|19.7|||<|0.001|TWO_SIDED|95.0|12.8|26.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2||26.7|12.8|<0.001
70909413|NCT02886728|141307204|SUPERIORITY||Difference in Response Rates|16.3|||<|0.001|TWO_SIDED|95.0|7.6|25.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2||25.0|7.6|<0.001
70909414|NCT02886728|141307204|SUPERIORITY||Difference in Response Rates|11.7||||0.004|TWO_SIDED|95.0|3.0|20.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2||20.4|3.0|0.004
70909415|NCT02886728|141307204|SUPERIORITY||Difference in Response Rates|18.5|||<|0.001|TWO_SIDED|95.0|11.7|25.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4||25.2|11.7|<0.001
70909416|NCT02886728|141307204|SUPERIORITY||Difference in Response Rates|7.1||||0.083|TWO_SIDED|95.0|-1.6|15.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4||15.8|-1.6|0.083
70909417|NCT02886728|141307204|SUPERIORITY||Difference in Response Rates|14.7|||<|0.001|TWO_SIDED|95.0|6.4|23.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4||23.1|6.4|<0.001
70909418|NCT02886728|141307204|SUPERIORITY||Difference in Response Rates|10.6|||<|0.001|TWO_SIDED|95.0|4.4|16.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12||16.7|4.4|<0.001
70909419|NCT02886728|141307204|SUPERIORITY||Difference in Response Rates|4.7||||0.22|TWO_SIDED|95.0|-3.1|12.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12||12.6|-3.1|0.22
70909420|NCT02886728|141307204|SUPERIORITY||Difference in Response Rates|4.3||||0.25|TWO_SIDED|95.0|-3.6|12.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12||12.1|-3.6|0.25
71031051|NCT01507051|141570196|SUPERIORITY_OR_OTHER||Geometric LS-Mean Ratio|2.793|||<|0.0001||90.0|2.633|2.962|||ANOVA|||||2.962|2.633|<0.0001
70909421|NCT02886728|141307204|SUPERIORITY||Difference in Response Rates|2.7||||0.35|TWO_SIDED|95.0|-3.5|8.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24||8.9|-3.5|0.35
70909422|NCT02886728|141307204|SUPERIORITY||Difference in Response Rates|4.6||||0.2|TWO_SIDED|95.0|-2.9|12.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24||12.1|-2.9|0.20
70909423|NCT02886728|141307204|SUPERIORITY||Difference in Response Rates|3.1||||0.36|TWO_SIDED|95.0|-4.5|10.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24||10.6|-4.5|0.36
70909424|NCT02886728|141307204|SUPERIORITY||Difference in Response Rates|6.3||||0.043|TWO_SIDED|95.0|-0.2|12.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36||12.8|-0.2|0.043
70909425|NCT02886728|141307204|SUPERIORITY||Difference in Response Rates|9.4||||0.015|TWO_SIDED|95.0|1.6|17.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36||17.2|1.6|0.015
70909426|NCT02886728|141307204|SUPERIORITY||Difference in Response Rates|6.5||||0.085|TWO_SIDED|95.0|-1.5|14.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36||14.4|-1.5|0.085
70909427|NCT02886728|141307204|SUPERIORITY||Difference in Response Rates|9.9||||0.002|TWO_SIDED|95.0|3.2|16.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52||16.6|3.2|0.002
71031052|NCT01507051|141570197|SUPERIORITY_OR_OTHER||Geometric LS-Mean Ratio|6.151|||<|0.0001||90.0|5.598|6.759|||ANOVA|||||6.759|5.598|<0.0001
71031053|NCT01507051|141570224|SUPERIORITY_OR_OTHER||Geometric LS-Mean Ratio (%)|95.17||||0.5008||95.0|82.2|110.2|||ANOVA|||||110.2|82.20|0.5008
71031054|NCT01507051|141570225|SUPERIORITY_OR_OTHER||Geometric LS-Mean Ratio (%)|99.46||||0.9429||95.0|85.47|115.7|||ANOVA|||||115.7|85.47|0.9429
70909428|NCT02886728|141307204|SUPERIORITY||Difference in Response Rates|10.5||||0.01|TWO_SIDED|95.0|2.3|18.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52||18.7|2.3|0.010
70970477|NCT02706873|141446961|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|Response Rate Difference|25.0|||<|0.001|TWO_SIDED|95.0|17.6|32.4||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||32.4|17.6|<0.001
70970478|NCT02706873|141446961|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|Response Rate Difference|26.4|||<|0.001|TWO_SIDED|95.0|19.0|33.9||The nominal p-value is reported|Chi-squared, Corrected|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|||Response Rate Difference = Upadacitinib - Methotrexate|33.9|19.0|<0.001
70970479|NCT02706873|141446962|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|4.25|||<|0.001|TWO_SIDED|95.0|3.0|5.5||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||5.50|3.00|<0.001
70970480|NCT02706873|141446962|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|4.34|||<|0.001|TWO_SIDED|95.0|3.09|5.59||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||5.59|3.09|<0.001
70970481|NCT02706873|141446963|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|-0.92|||<|0.001|TWO_SIDED|95.0|-1.12|-0.71||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.71|-1.12|<0.001
70970482|NCT02706873|141446963|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|-1.19|||<|0.001|TWO_SIDED|95.0|-1.4|-0.99||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.99|-1.40|<0.001
70970483|NCT02706873|141446964|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|-0.27|||<|0.001|TWO_SIDED|95.0|-0.37|-0.17||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.17|-0.37|<0.001
70970484|NCT02706873|141446964|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.41|-0.21||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.21|-0.41|<0.001
70970485|NCT02706873|141446965|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|26.8|||<|0.001|TWO_SIDED|95.0|19.3|34.3||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||34.3|19.3|<0.001
70970486|NCT02706873|141446965|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|32.2|||<|0.001|TWO_SIDED|95.0|24.8|39.6||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||39.6|24.8|<0.001
70970487|NCT02706873|141446966|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|27.8|||<|0.001|TWO_SIDED|95.0|20.3|35.2||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||35.2|20.3|<0.001
71008714|NCT02055976|141525246|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.755|STANDARD_ERROR_OF_MEAN|1.479|<|0.001|TWO_SIDED|95.0|-11.692|-5.817|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-5.817|-11.692|<0.001
71031055|NCT01507051|141570226|SUPERIORITY_OR_OTHER||Geometric LS-Mean Ratio (%)|100.4||||0.9525||95.0|88.0|114.5|||ANOVA|||||114.5|88.00|0.9525
70909429|NCT02886728|141307204|SUPERIORITY||Difference in Response Rates|9.6||||0.014|TWO_SIDED|95.0|1.4|17.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52||17.8|1.4|0.014
70909430|NCT02886728|141307205|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.9|-0.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.6|-0.9|<0.001
70909431|NCT02886728|141307205|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.7|-0.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.4|-0.7|<0.001
70909432|NCT02886728|141307205|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.9|-0.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.6|-0.9|<0.001
70909433|NCT02886728|141307205|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-1.1|-0.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.8|-1.1|<0.001
70909434|NCT02886728|141307205|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.9|-0.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.5|-0.9|<0.001
70909435|NCT02886728|141307205|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-1.0|-0.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.7|-1.0|<0.001
70909436|NCT02886728|141307205|SUPERIORITY||Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-1.0|-0.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.7|-1.0|<0.001
70909437|NCT02886728|141307205|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.8|-0.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.4|-0.8|<0.001
70909438|NCT02886728|141307205|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.9|-0.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.5|-0.9|<0.001
70909439|NCT02886728|141307205|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.9|-0.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.6|-0.9|<0.001
70909440|NCT02886728|141307205|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.7|-0.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.3|-0.7|<0.001
70909441|NCT02886728|141307205|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.7|-0.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.3|-0.7|<0.001
71031056|NCT01507051|141570227|SUPERIORITY_OR_OTHER||Geometric LS-Mean Ratio (%)|95.87||||0.4397||95.0|85.99|106.9|||ANOVA|||||106.9|85.99|0.4397
71031057|NCT00581139|141570273|SUPERIORITY|||||||0.02|||||||ANOVA|||||||.02
71031058|NCT00581139|141570275|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||.01
71031059|NCT00581139|141570276|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||.01
71031060|NCT00581139|141570277|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||.01
71031061|NCT00581139|141570278|SUPERIORITY|||||||0.02|||||||ANOVA|||||||.02
71031062|NCT00581139|141570279|SUPERIORITY|||||||0.04|||||||ANOVA|||||||.04
71031063|NCT00581139|141570280|SUPERIORITY|||||||0.04|||||||ANOVA|||||||.04
71031064|NCT01136382|141570288|SUPERIORITY_OR_OTHER||LS mean difference|13.6|STANDARD_ERROR_OF_MEAN|3.1|<|0.0001|TWO_SIDED|95.0|7.5|19.7||To address multiplicity, a step-down procedure was used. If the treatment difference for the primary variable, morning PEF, was statistically significant (p\<0.05), then the key secondary variable, FEV1, was tested at the 0.05 level of significance.|ANCOVA|||Change from baseline to treatment period average was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||19.7|7.5|<0.0001
71031065|NCT01136382|141570289|SUPERIORITY_OR_OTHER||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.022||0.0047|TWO_SIDED|95.0|0.02|0.11||To address multiplicity, a step-down procedure was used. If the treatment difference for the primary variable, morning PEF, was statistically significant (p\<0.05), then the key secondary variable, FEV1, was tested at the 0.05 level of significance.|ANCOVA|||Change from baseline to treatment period average was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||0.11|0.02|0.0047
70909442|NCT02886728|141307205|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.6|-0.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.3|-0.6|<0.001
71031066|NCT01136382|141570290|SUPERIORITY_OR_OTHER||LS mean difference|10.8|STANDARD_ERROR_OF_MEAN|3.0||0.0004|TWO_SIDED|95.0|4.9|16.7|||ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||16.7|4.9|0.0004
71031067|NCT01136382|141570291|SUPERIORITY_OR_OTHER||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.0673|TWO_SIDED|95.0|0.0|0.08|||ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||0.08|0.00|0.0673
71031068|NCT01136382|141570292|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.044||0.0216|TWO_SIDED|95.0|0.01|0.19|||ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||0.19|0.01|0.0216
71031069|NCT01136382|141570293|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.06||0.0004|TWO_SIDED|95.0|-0.31|-0.09||Analysis for change in daytime asthma symptom score from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-0.09|-0.31|0.0004
71031070|NCT01136382|141570293|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.11||0.0015|TWO_SIDED|95.0|-0.55|-0.13||Analysis for change in total asthma symptom score from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-0.13|-0.55|0.0015
71031071|NCT01136382|141570294|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.06||0.0079|TWO_SIDED|95.0|-0.26|-0.04|||ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-0.04|-0.26|0.0079
71031072|NCT01136382|141570295|SUPERIORITY_OR_OTHER||LS mean difference|-4.7|STANDARD_ERROR_OF_MEAN|1.78||0.0095|TWO_SIDED|95.0|-8.2|-1.1||Analysis for change in nighttime awakenings from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-1.1|-8.2|0.0095
71031073|NCT01136382|141570295|SUPERIORITY_OR_OTHER||LS mean difference|-3.9|STANDARD_ERROR_OF_MEAN|1.15||0.0007|TWO_SIDED|95.0|-6.2|-1.7||Analysis for change in nighttime awakenings with reliever medication use from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-1.7|-6.2|0.0007
71031074|NCT01136382|141570296|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.07||0.0001|TWO_SIDED|95.0|-0.4|-0.1||Analysis for change in daytime reliever medication use from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-0.1|-0.4|0.0001
71031075|NCT01136382|141570296|SUPERIORITY_OR_OTHER||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.7|-0.2||Analysis for change in total reliever medication use from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-0.2|-0.7|<0.0001
71031076|NCT01136382|141570297|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.3|-0.1|||ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-0.1|-0.3|<0.0001
71031077|NCT01136382|141570298|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Log Rank|||||||0.0004
71031078|NCT00963482|141570299|SUPERIORITY_OR_OTHER||||||=|0.111||95.0||||not adjusted for multiple comparisons due to only two groups p\<.05, two-tailed|Chi-squared|||"H0: EG is equal in smoking quit rates compared to CG. H1: EG is superior in smoking quit rates compared to CG"||||=.111
70909443|NCT02886728|141307205|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.033|TWO_SIDED|95.0|-0.4|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-0.4|0.033
70909444|NCT02886728|141307205|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.2|-0.6|<0.001
70909445|NCT02886728|141307205|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.8|-0.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.5|-0.8|<0.001
70909446|NCT02886728|141307205|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.2|-0.6|<0.001
70909447|NCT02886728|141307205|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.7|-0.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.3|-0.7|<0.001
70909448|NCT02886728|141307206|SUPERIORITY||Difference in Response Rates|18.8|||<|0.001|TWO_SIDED|95.0|13.1|24.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4||24.4|13.1|<0.001
70909449|NCT02886728|141307206|SUPERIORITY||Difference in Response Rates|11.7|||<|0.001|TWO_SIDED|95.0|4.7|18.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4||18.6|4.7|<0.001
70909450|NCT02886728|141307206|SUPERIORITY||Difference in Response Rates|19.9|||<|0.001|TWO_SIDED|95.0|12.5|27.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4||27.3|12.5|<0.001
70909451|NCT02886728|141307206|SUPERIORITY||Difference in Response Rates|27.2|||<|0.001|TWO_SIDED|95.0|20.5|33.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12||33.9|20.5|<0.001
70909452|NCT02886728|141307206|SUPERIORITY||Difference in Response Rates|21.6|||<|0.001|TWO_SIDED|95.0|13.2|30.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12||30.1|13.2|<0.001
70909453|NCT02886728|141307206|SUPERIORITY||Difference in Response Rates|19.5|||<|0.001|TWO_SIDED|95.0|11.1|27.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12||27.9|11.1|<0.001
70909454|NCT02886728|141307206|SUPERIORITY||Difference in Response Rates|22.6|||<|0.001|TWO_SIDED|95.0|15.8|29.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24||29.4|15.8|<0.001
70909455|NCT02886728|141307206|SUPERIORITY||Difference in Response Rates|16.6|||<|0.001|TWO_SIDED|95.0|8.1|25.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24||25.2|8.1|<0.001
70909456|NCT02886728|141307206|SUPERIORITY||Difference in Response Rates|13.8|||<|0.001|TWO_SIDED|95.0|5.3|22.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24||22.4|5.3|<0.001
70909457|NCT02886728|141307206|SUPERIORITY||Difference in Response Rates|21.4|||<|0.001|TWO_SIDED|95.0|14.6|28.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52||28.2|14.6|<0.001
71031079|NCT00485472|141570305|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.36||||0.5438||95.0|-5.3|10.02|||ANCOVA|||The ANCOVA analysis includes treatment and pooled site as factors and baseline score as covariate.||10.02|-5.30|0.5438
70909458|NCT02886728|141307206|SUPERIORITY||Difference in Response Rates|12.3||||0.003|TWO_SIDED|95.0|3.7|20.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52||20.9|3.7|0.003
70909459|NCT02886728|141307206|SUPERIORITY||Difference in Response Rates|18.1|||<|0.001|TWO_SIDED|95.0|9.7|26.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52||26.5|9.7|<0.001
70909460|NCT02886728|141307207|SUPERIORITY||Difference in Response Rates|6.3|||<|0.001|TWO_SIDED|95.0|3.4|9.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2||9.1|3.4|<0.001
71031080|NCT00485472|141570306|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.83||||0.2022||95.0|-2.62|12.28|||ANCOVA|||The ANCOVA analysis includes treatment and pooled site as factors and baseline score as covariate.||12.28|-2.62|0.2022
71031081|NCT00485472|141570307|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.79||||0.665||95.0|-6.36|9.93|||ANCOVA|||The ANCOVA analysis includes treatment and pooled site as factors and baseline score as covariate.||9.93|-6.36|0.6650
71031082|NCT00485472|141570308|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.74||||0.3445||95.0|-11.65|33.13|||ANCOVA|||The ANCOVA analysis includes treatment and pooled site as factors and baseline score as covariate.||33.13|-11.65|0.3445
71031083|NCT00485472|141570310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.488||||0.0418||95.0|0.245|0.974|||Likelihood ratio test|||Analysis of 'response' based on a likelihood ratio test with treatment and pooled site as factors.||0.974|0.245|0.0418
71031084|NCT00365300|141570344|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.004||||1|||||||Fisher Exact|||||||1.0
71031085|NCT01287013|141570356|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71031086|NCT01287013|141570357|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71031087|NCT01287013|141570358|OTHER||||||<|0.04|||||||t-test, 2 sided|||||||<0.04
71031088|NCT01287013|141570359|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71031089|NCT01287013|141570360|SUPERIORITY_OR_OTHER||||||=|0.67|||||||t-test, 2 sided|||||||=0.67
71031090|NCT01045096|141570361|SUPERIORITY_OR_OTHER|||||||0.809||90.0|||||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An analysis of variance with covariates (ANCOVA) model with weight as a covariate and regimen as a factor were fitted to Tmax. Pairwise comparisons between regimens were conducted.||||0.809
71031091|NCT01045096|141570362|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.2|||||TWO_SIDED|90.0|0.66|2.183|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized Cmax. Pairwise comparisons between regimens were conducted.||2.183|0.660|
71031092|NCT01045096|141570362|SUPERIORITY_OR_OTHER||Dose proportionality Point Estimate|1.06|||||TWO_SIDED|90.0|0.463|2.427|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized Cmax. Pairwise comparisons between regimens were conducted.||2.427|0.463|
71031093|NCT01045096|141570362|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|0.88|||||TWO_SIDED|90.0|0.493|1.579|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized Cmax. Pairwise comparisons between regimens were conducted.||1.579|0.493|
71031094|NCT01045096|141570363|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.13|||||TWO_SIDED|90.0|0.693|1.848|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC\[0-tlqc\]. Pairwise comparisons between regimens were conducted.||1.848|0.693|
71031095|NCT01045096|141570363|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.15|||||TWO_SIDED|90.0|0.584|2.276|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC\[0-tlqc\]. Pairwise comparisons between regimens were conducted.||2.276|0.584|
71031096|NCT01045096|141570363|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.02|||||TWO_SIDED|90.0|0.632|1.642|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC\[0-tlqc\]. Pairwise comparisons between regimens were conducted.||1.642|0.632|
71031097|NCT01045096|141570364|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.06|||||TWO_SIDED|90.0|0.692|1.636|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC\[0-24\]. Pairwise comparisons between regimens were conducted.||1.636|0.692|
71031098|NCT01045096|141570364|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.26|||||TWO_SIDED|90.0|0.691|2.314|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC\[0-24\]. Pairwise comparisons between regimens were conducted.||2.314|0.691|
70909461|NCT02886728|141307207|SUPERIORITY||Difference in Response Rates|3.4||||0.01|TWO_SIDED|95.0|0.1|6.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2||6.7|0.1|0.010
71031099|NCT01045096|141570364|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.19|||||TWO_SIDED|95.0|0.777|1.817|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC\[0-24\]. Pairwise comparisons between regimens were conducted.||1.817|0.777|
71092006|NCT01155323|141690595|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.50|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.22|0.22|||||The mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be non-inferior to omafilcon A for lens handling.||0.22|-0.22|
71092007|NCT01155323|141690596|NON_INFERIORITY_OR_EQUIVALENCE|Margin = +/-0.50|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.03|0.01|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be equivalent to omafilcon A for corneal staining.||0.01|-0.03|
70909462|NCT02886728|141307207|SUPERIORITY||Difference in Response Rates|9.0|||<|0.001|TWO_SIDED|95.0|4.5|13.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2||13.6|4.5|<0.001
70909463|NCT02886728|141307207|SUPERIORITY||Difference in Response Rates|11.8|||<|0.001|TWO_SIDED|95.0|7.4|16.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4||16.1|7.4|<0.001
70909464|NCT02886728|141307207|SUPERIORITY||Difference in Response Rates|10.2|||<|0.001|TWO_SIDED|95.0|4.5|15.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4||15.8|4.5|<0.001
70909465|NCT02886728|141307207|SUPERIORITY||Difference in Response Rates|14.7|||<|0.001|TWO_SIDED|95.0|8.6|20.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4||20.8|8.6|<0.001
70909466|NCT02886728|141307207|SUPERIORITY||Difference in Response Rates|22.6|||<|0.001|TWO_SIDED|95.0|16.4|28.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12||28.8|16.4|<0.001
70909467|NCT02886728|141307207|SUPERIORITY||Difference in Response Rates|14.8|||<|0.001|TWO_SIDED|95.0|7.1|22.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12||22.5|7.1|<0.001
70909468|NCT02886728|141307207|SUPERIORITY||Difference in Response Rates|12.5|||<|0.001|TWO_SIDED|95.0|4.9|20.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12||20.0|4.9|<0.001
70909469|NCT02886728|141307207|SUPERIORITY||Difference in Response Rates|18.3|||<|0.001|TWO_SIDED|95.0|11.4|25.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36||25.1|11.4|<0.001
70909470|NCT02886728|141307207|SUPERIORITY||Difference in Response Rates|7.7||||0.056|TWO_SIDED|95.0|-0.8|16.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36||16.1|-0.8|0.056
70909471|NCT02886728|141307207|SUPERIORITY||Difference in Response Rates|9.0||||0.023|TWO_SIDED|95.0|0.5|17.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36||17.4|0.5|0.023
70909472|NCT02886728|141307207|SUPERIORITY||Difference in Response Rates|21.9|||<|0.001|TWO_SIDED|95.0|15.1|28.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52||28.7|15.1|<0.001
70909473|NCT02886728|141307207|SUPERIORITY||Difference in Response Rates|11.5||||0.004|TWO_SIDED|95.0|3.1|20.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52||20.0|3.1|0.004
70909474|NCT02886728|141307207|SUPERIORITY||Difference in Response Rates|14.7|||<|0.001|TWO_SIDED|95.0|6.3|23.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52||23.1|6.3|<0.001
70909475|NCT02886728|141307210|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|0.82|<|0.001|TWO_SIDED|95.0|-7.3|-4.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.1|-7.3|<0.001
70909476|NCT02886728|141307210|SUPERIORITY||Least Squares Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|1.01|<|0.001|TWO_SIDED|95.0|-6.4|-2.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.4|-6.4|<0.001
70909477|NCT02886728|141307210|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|1.01|<|0.001|TWO_SIDED|95.0|-7.7|-3.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.7|-7.7|<0.001
70909478|NCT02886728|141307210|SUPERIORITY||Least Squares Mean Difference|-7.3|STANDARD_ERROR_OF_MEAN|0.83|<|0.001|TWO_SIDED|95.0|-8.9|-5.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.6|-8.9|<0.001
70909479|NCT02886728|141307210|SUPERIORITY||Least Squares Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|1.02|<|0.001|TWO_SIDED|95.0|-7.3|-3.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.3|-7.3|<0.001
70909480|NCT02886728|141307210|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|1.02|<|0.001|TWO_SIDED|95.0|-7.8|-3.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.7|-7.8|<0.001
70909481|NCT02886728|141307210|SUPERIORITY||Least Squares Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|0.72|<|0.001|TWO_SIDED|95.0|-7.3|-4.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.4|-7.3|<0.001
70909482|NCT02886728|141307210|SUPERIORITY||Least Squares Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|0.88|<|0.001|TWO_SIDED|95.0|-6.1|-2.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.7|-6.1|<0.001
70909483|NCT02886728|141307210|SUPERIORITY||Least Squares Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|0.88|<|0.001|TWO_SIDED|95.0|-6.8|-3.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.4|-6.8|<0.001
70909484|NCT02886728|141307210|SUPERIORITY||Least Squares Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|0.61|<|0.001|TWO_SIDED|95.0|-5.3|-2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.9|-5.3|<0.001
70909485|NCT02886728|141307210|SUPERIORITY||Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.75|<|0.001|TWO_SIDED|95.0|-4.3|-1.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.3|-4.3|<0.001
70909486|NCT02886728|141307210|SUPERIORITY||Least Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.75|<|0.001|TWO_SIDED|95.0|-4.4|-1.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.4|-4.4|<0.001
70909487|NCT02886728|141307210|SUPERIORITY||Least Squares Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|-3.4|-1.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.1|-3.4|<0.001
70909488|NCT02886728|141307210|SUPERIORITY||Least Squares Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.71||0.36|TWO_SIDED|95.0|-2.0|0.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.8|-2.0|0.36
70909489|NCT02886728|141307210|SUPERIORITY||Least Squares Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.72||0.009|TWO_SIDED|95.0|-3.3|-0.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.5|-3.3|0.009
70909490|NCT02886728|141307210|SUPERIORITY||Least Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|-4.5|-2.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.2|-4.5|<0.001
70909491|NCT02886728|141307210|SUPERIORITY||Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.69||0.042|TWO_SIDED|95.0|-2.7|-0.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.1|-2.7|0.042
70909492|NCT02886728|141307210|SUPERIORITY||Least Squares Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.69|<|0.001|TWO_SIDED|95.0|-3.7|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.7|<0.001
70909493|NCT02886728|141307211|SUPERIORITY||Least Squares Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|95.0|-8.5|-5.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.2|-8.5|<0.001
70909494|NCT02886728|141307211|SUPERIORITY||Least Squares Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-7.3|-3.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.3|-7.3|<0.001
70909495|NCT02886728|141307211|SUPERIORITY||Least Squares Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|1.03|<|0.001|TWO_SIDED|95.0|-8.8|-4.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.7|-8.8|<0.001
70909496|NCT02886728|141307211|SUPERIORITY||Least Squares Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|95.0|-9.9|-6.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.6|-9.9|<0.001
70909497|NCT02886728|141307211|SUPERIORITY||Least Squares Mean Difference|-6.2|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-8.2|-4.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.1|-8.2|<0.001
70909498|NCT02886728|141307211|SUPERIORITY||Least Squares Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-8.5|-4.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.5|-8.5|<0.001
70909499|NCT02886728|141307211|SUPERIORITY||Least Squares Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|0.74|<|0.001|TWO_SIDED|95.0|-8.0|-5.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.1|-8.0|<0.001
70909500|NCT02886728|141307211|SUPERIORITY||Least Squares Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-6.5|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-6.5|<0.001
70909501|NCT02886728|141307211|SUPERIORITY||Least Squares Mean Difference|-5.6|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-7.4|-3.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.8|-7.4|<0.001
70909502|NCT02886728|141307211|SUPERIORITY||Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-5.9|-3.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.4|-5.9|<0.001
70909503|NCT02886728|141307211|SUPERIORITY||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|0.78|<|0.001|TWO_SIDED|95.0|-4.6|-1.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.6|-4.6|<0.001
70909504|NCT02886728|141307211|SUPERIORITY||Least Squares Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.79|<|0.001|TWO_SIDED|95.0|-4.9|-1.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.9|-4.9|<0.001
70909505|NCT02886728|141307211|SUPERIORITY||Least Squares Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.61|<|0.001|TWO_SIDED|95.0|-3.8|-1.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.4|-3.8|<0.001
70909506|NCT02886728|141307211|SUPERIORITY||Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.74||0.23|TWO_SIDED|95.0|-2.4|0.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.6|-2.4|0.23
71031100|NCT01179048|141570368|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of liraglutide versus placebo was considered confirmed, if the upper limit of the two-sided 95% CI for the hazard ratio was below 1.3 or if the p-value for the one-sided test of H0: HR \>=1.3 against Ha: HR \<1.3 was less than 2.5% (or equivalent to 5% in two-sided test). If non-inferiority was established for the primary outcome, a test for superiority was to be performed.|Hazard Ratio (HR)|0.868|||<|0.001|TWO_SIDED|95.0|0.778|0.968||p-value is reported for one-sided (α-level 0.025) test for non-inferiority (hazard ratio \>=1.3).|Regression, Cox|||The primary endpoint was evaluated using the Cox regression model to estimate the hazard ratio (HR) (liraglutide/placebo) and the 2-sided 95% confidence interval (CI) including treatment group as factor. Non-inferiority of liraglutide versus placebo was considered confirmed, if the upper limit of the two-sided 95% CI for the hazard ratio was below 1.3 or if the p-value for the one-sided test of H0: HR \>=1.3 against Ha: HR \<1.3 was less than 2.5% (or equivalent to 5% in two-sided test).||0.968|0.778|<0.001
71031101|NCT01179048|141570368|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.868||||0.005|TWO_SIDED|95.0|0.778|0.968||p-value is reported for one-sided (α-level 0.025) test for superiority (hazard ratio\>=1.0).|Regression, Cox|||If non-inferiority was established for the primary outcome, a test for superiority was performed. Superiority of liraglutide versus placebo was considered confirmed, if the upper limit of the two-sided 95% CI for the hazard ratio was below 1.0 or equivalent if the p-value for the one-sided test of H0: HR \>=1.0 against Ha: HR \<1.0 was less than 2.5% (or equivalent to 5% in two-sided test).||0.968|0.778|0.005
71031102|NCT01179048|141570369|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.881|||||TWO_SIDED|95.0|0.807|0.962|||Regression, Cox|The analysis was done using a Cox regression model with treatment as a fixed factor including all randomised subjects.||||0.962|0.807|
71031103|NCT01179048|141570370|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.847|||||TWO_SIDED|95.0|0.739|0.971|||Regression, Cox|The analysis was done using a Cox regression model with treatment as a fixed factor including all randomised subjects.||||0.971|0.739|
71031104|NCT01179048|141570371|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.783|||||TWO_SIDED|95.0|0.656|0.934|||Regression, Cox|||Analysis for percentage of subjects experiencing cardiovascular death was done by Cox regression model with treatment as fixed factor.||0.934|0.656|
71031105|NCT01179048|141570371|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.894|||||TWO_SIDED|95.0|0.721|1.107|||Regression, Cox|||Analysis for percentage of subjects experiencing non-fatal stroke was done by Cox regression model with treatment as fixed factor||1.107|0.721|
71031106|NCT01179048|141570371|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.878|||||TWO_SIDED|95.0|0.747|1.031|||Regression, Cox|||Analysis for percentage of subjects experiencing non-fatal myocardial infarction was done by Cox regression model with treatment as fixed factor||1.031|0.747|
71031107|NCT01179048|141570371|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.763|1.258|||Regression, Cox|||Analysis for percentage of subjects experiencing hospitalisation for unstable angina pectoris was done by Cox regression model with treatment as fixed factor||1.258|0.763|
71031108|NCT01179048|141570371|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.912|||||TWO_SIDED|95.0|0.797|1.044|||Regression, Cox|||Analysis for percentage of subjects experiencing coronary revascularisation was done by Cox regression model with treatment as fixed factor||1.044|0.797|
71031109|NCT01179048|141570371|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.872|||||TWO_SIDED|95.0|0.727|1.046|||Regression, Cox|||Analysis for percentage of subjects experiencing hospitalisation for heart failure was done by Cox regression model with treatment as fixed factor||1.046|0.727|
71031110|NCT01179048|141570372|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.841|||||TWO_SIDED|95.0|0.73|0.969|||Regression, Cox|||Analysis for percentage of subjects experiencing a first microvascular event was done by Cox regression model with treatment as fixed factor.||0.969|0.730|
71031111|NCT01179048|141570373|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.782|||||TWO_SIDED|95.0|0.666|0.918|||Regression, Cox|||Analysis for percentage of subjects experiencing a composite nephropathy event was done by Cox regression model with treatment as fixed factor.||0.918|0.666|
71031112|NCT01179048|141570373|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.738|||||TWO_SIDED|95.0|0.602|0.905|||Regression, Cox|||Analysis for percentage of subjects experiencing a new onset of persistant macroalbuminaria event was done by Cox regression model with treatment as fixed factor.||0.905|0.602|
71031113|NCT01179048|141570373|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.667|1.189|||Regression, Cox|||Analysis for percentage of subjects experiencing persistent doubling of serum creatinine was done by Cox regression model with treatment as fixed factor.||1.189|0.667|
71031114|NCT01179048|141570373|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.869|||||TWO_SIDED|95.0|0.607|1.244|||Regression, Cox|||Analysis for percentage of subjects experiencing a need for continuous renal-replacement therapy was done by Cox regression model with treatment as fixed factor.||1.244|0.607|
71153651|NCT03530124|141799878|SUPERIORITY|The proportion of infants requiring an increase in respiratory support for each group were compared using a Mantel-Haenszel statistic in a stratified analysis by study site and gestational age group to control for the randomization blocks at the two-sided alpha 0.05 level and corresponding 95% confidence interval for the occurrence of apnea.|Odds Ratio (OR)|2.07||||0.3555|TWO_SIDED|95.0|0.59|7.23|||Mantel Haenszel||No adjustments were made to the alpha level (two-sided alpha=0.05) for the secondary objectives.|||7.23|0.59|0.3555
71031115|NCT01179048|141570373|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.593|||||TWO_SIDED|95.0|0.521|4.869|||Regression, Cox|||Analysis for percentage of subjects experiencing death due to renal disease was done by Cox regression model with treatment as fixed factor.||4.869|0.521|
71031116|NCT01179048|141570373|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.149|||||TWO_SIDED|95.0|0.869|1.519|||Regression, Cox|||Analysis for percentage of subjects experiencing composite retinopathy was done by Cox regression model with treatment as fixed factor.||1.519|0.869|
71031117|NCT01179048|141570373|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.159|||||TWO_SIDED|95.0|0.869|1.546|||Regression, Cox|||Analysis for percentage of subjects experiencing treatment with photocoagulation or intravitreal agents was done by Cox regression model with treatment as fixed factor.||1.546|0.869|
71031118|NCT01179048|141570373|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.335|||||TWO_SIDED|95.0|0.004|30.847|||Regression, Cox|||Analysis for percentage of subjects experiencing development of diabetes-related blindness was done by Cox regression model with treatment as fixed factor.||30.847|0.004|
71031119|NCT01179048|141570373|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.454|||||TWO_SIDED|95.0|0.845|2.502|||Regression, Cox|||Analysis for percentage of subjects experiencing vitreous haemorrhage was done by Cox regression model with treatment as fixed factor.||2.502|0.845|
70909507|NCT02886728|141307211|SUPERIORITY||Least Squares Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.75||0.005|TWO_SIDED|95.0|-3.6|-0.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.6|-3.6|0.005
70909508|NCT02886728|141307211|SUPERIORITY||Least Squares Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-5.0|-2.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.6|-5.0|<0.001
71031120|NCT03203447|141570380|SUPERIORITY||Difference in percentages|-7.1||||0.191|TWO_SIDED|95.0|-17.9|3.6||The a priori threshold for statistical significance was 0.050. Prior to evaluating the results of the CMH test, a Breslow-Day test with Tarone's adjustment was conducted to confirm the homogeneity of the odds ratios between RVO strata.|Cochran-Mantel-Haenszel|The CMH test was stratified by the type of retinal vein occlusion, i.e., branch vs. central.|Estimated value was calculated as the percentage of subjects in the Active arm meeting the primary endpoint minus the percentage of subjects in the Control arm meeting the primary endpoint.|Based on a Pearson chi-square test, a total sample size of approximately 460 subjects provided 90% power to detect a difference of 15% between the Active and Control arms assuming the Control arm showed a proportion of 0.50 at 8 weeks. The primary analysis was a test of superiority of the Active arm over the Control arm, and was based on a Cochran-Mantel-Haenszel chi-square test stratified by type of retinal vein occlusion.||3.6|-17.9|0.191
71031121|NCT00324168|141570383|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.009||||0.82|TWO_SIDED|95.0|-0.085|0.068|||Regression, Linear|Adjusted for enrollment BSCVA||||0.068|-0.085|0.82
71031122|NCT00324168|141570384|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06||||0.4|TWO_SIDED|95.0|-0.09|0.15|||Regression, Linear|||||0.15|-0.09|0.40
71031123|NCT00324168|141570385|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.873|TWO_SIDED|95.0|-0.07|0.08|||Regression, Linear|||||0.08|-0.07|0.873
71031124|NCT00324168|141570386|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.44|TWO_SIDED|95.0|0.76|1.12|||Regression, Cox|||||1.12|0.76|0.44
71031125|NCT00324168|141570387|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||||||>0.99
71031126|NCT00324168|141570388|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.39|TWO_SIDED|95.0|-0.12|0.05|||Regression, Linear|||||0.05|-0.12|0.39
71031127|NCT00324168|141570389|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.78||95.0|-0.09|0.07|||Regression, Linear|||||0.07|-0.09|0.78
71031128|NCT00324168|141570390|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12||||0.3|TWO_SIDED|95.0|-0.011|0.35|||Regression, Linear|||Nocardia spp||0.35|-.011|0.30
71031129|NCT00324168|141570390|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.86||95.0|-0.12|0.1|||Regression, Linear|||Streptococcus pneumoniae||0.10|-0.12|0.86
71031130|NCT00324168|141570390|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.65|TWO_SIDED|95.0|-0.34|0.55|||Regression, Linear|||Moraxella spp||0.55|-0.34|0.65
71031131|NCT00324168|141570390|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.67|TWO_SIDED|95.0|-0.2|0.13|||Regression, Linear|||Pseudomonas aeruginosa||0.13|-0.20|0.67
71031132|NCT00324168|141570391|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.33|TWO_SIDED|95.0|-0.08|0.25|||Regression, Linear|||\<20/40||0.25|-0.08|0.33
71031133|NCT00324168|141570391|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.85|TWO_SIDED|95.0|-0.09|0.11|||Regression, Linear|||20/40 to 20/800||0.11|-0.09|0.85
71031134|NCT00324168|141570391|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.03|TWO_SIDED|95.0|-0.31|-0.02|||Regression, Linear|||CF or worse||-0.02|-0.31|0.03
71031135|NCT00324168|141570392|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06||||0.31|TWO_SIDED|95.0|-0.05|0.17|||Regression, Linear|||\>0-33%||0.17|-0.05|0.31
71031136|NCT00324168|141570392|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.94|TWO_SIDED|95.0|-0.13|0.14|||Regression, Linear|||\>33%-67%||0.14|-0.13|0.94
71031137|NCT00324168|141570392|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.07|TWO_SIDED|95.0|-0.31|0.01|||Regression, Linear|||\>67%-100%||0.01|-0.31|0.07
71031138|NCT00324168|141570393|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.53|TWO_SIDED|95.0|-0.1|0.2|||Regression, Linear|||0-1.90 mm||0.20|-0.10|0.53
71031139|NCT00324168|141570393|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.95|TWO_SIDED|95.0|-0.15|0.16|||Regression, Linear|||1.91-2.70 mm||0.16|-0.15|0.95
71031140|NCT00324168|141570393|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.7|TWO_SIDED|95.0|-0.12|0.18|||Regression, Linear|||2.71-4.06 mm||0.18|-0.12|0.70
71031141|NCT00324168|141570393|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.07|TWO_SIDED|95.0|-0.31|0.01|||Regression, Linear|||4.07-8.90 mm||0.01|-0.31|0.07
71031142|NCT03497897|141570399|OTHER|The effects included in the model are: log transformed baseline inflammatory facial lesion count, treatment group, visit, treatment group by visit interaction, log transformed baseline inflammatory facial lesion count by visit interaction and type of center.|Posterior geometric mean ratio|0.93|||||TWO_SIDED|90.0|0.64|1.34|||Bayesian analysis|Bayesian mixed effect model with repeated measures|90% credible intervals are reported on the geometric means ratio|||1.34|0.64|
71031143|NCT03497897|141570399|OTHER|The effects included in the model are: log transformed baseline inflammatory facial lesion count, treatment group, visit, treatment group by visit interaction, log transformed baseline inflammatory facial lesion count by visit interaction and type of center.|P(Geometric Mean Ratio<1)|0.637|||||||||||Bayesian analysis|Bayesian mixed effect model with repeated measures|Posterior probability on geometric mean ratio is reported.|||||
71031144|NCT03497897|141570399|OTHER|The effects included in the model are: log transformed baseline inflammatory facial lesion count, treatment group, visit, treatment group by visit interaction, log transformed baseline inflammatory facial lesion count by visit interaction and type of center.|P(Geometric Mean Ratio<0.75)|0.171|||||||||||Bayesian analysis|Bayesian mixed effect model with repeated measures|Posterior probability on geometric mean ratio is reported.|||||
71031145|NCT02627924|141570402|OTHER||||||<|0.0001|||||||Paired t-test|The mean change was tested with a paired t-test without adjusting for baseline disease severity.||||||<0.0001
70909509|NCT02886728|141307211|SUPERIORITY||Least Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.73||0.021|TWO_SIDED|95.0|-3.1|-0.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.3|-3.1|0.021
70909510|NCT02886728|141307211|SUPERIORITY||Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.73|<|0.001|TWO_SIDED|95.0|-4.3|-1.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.4|-4.3|<0.001
70909511|NCT02886728|141307212|SUPERIORITY||Difference in Response Rates|7.6||||0.006|TWO_SIDED|95.0|2.2|12.9||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0.5||12.9|2.2|0.006
70909512|NCT02886728|141307212|SUPERIORITY||Difference in Response Rates|4.9||||0.16|TWO_SIDED|95.0|-1.8|11.6||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0.5||11.6|-1.8|0.16
70909513|NCT02886728|141307212|SUPERIORITY||Difference in Response Rates|7.6||||0.029|TWO_SIDED|95.0|1.1|14.1||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0.5||14.1|1.1|0.029
70909514|NCT02886728|141307212|SUPERIORITY||Difference in Response Rates|8.1||||0.015|TWO_SIDED|95.0|1.6|14.6||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0||14.6|1.6|0.015
70909515|NCT02886728|141307212|SUPERIORITY||Difference in Response Rates|4.2||||0.33|TWO_SIDED|95.0|-3.9|12.2||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0||12.2|-3.9|0.33
70909516|NCT02886728|141307212|SUPERIORITY||Difference in Response Rates|10.2||||0.013|TWO_SIDED|95.0|2.5|17.9||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0||17.9|2.5|0.013
70909517|NCT02886728|141307212|SUPERIORITY||Difference in Response Rates|3.6||||0.074|TWO_SIDED|95.0|-0.3|7.6||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= SDC (1.53)||7.6|-0.3|0.074
70909518|NCT02886728|141307212|SUPERIORITY||Difference in Response Rates|1.9||||0.49|TWO_SIDED|95.0|-3.1|6.9||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= SDC (1.53)||6.9|-3.1|0.49
70909519|NCT02886728|141307212|SUPERIORITY||Difference in Response Rates|4.4||||0.075|TWO_SIDED|95.0|-0.2|8.9||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24 for Change in mTSS \<= SDC (1.53)||8.9|-0.2|0.075
70909520|NCT02886728|141307212|SUPERIORITY||Difference in Response Rates|10.2|||<|0.001|TWO_SIDED|95.0|4.3|16.2||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0.5||16.2|4.3|<0.001
70909521|NCT02886728|141307212|SUPERIORITY||Difference in Response Rates|7.9||||0.045|TWO_SIDED|95.0|0.7|15.2||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0.5||15.2|0.7|0.045
70909522|NCT02886728|141307212|SUPERIORITY||Difference in Response Rates|6.5||||0.1|TWO_SIDED|95.0|-1.1|14.0||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0.5||14.0|-1.1|0.100
71031146|NCT02627924|141570403|OTHER||||||<|0.0001|||||||Paired t-test|The mean change was tested with a paired t-test without adjusting for baseline disease severity.||||||<0.0001
70909523|NCT02886728|141307212|SUPERIORITY||Difference in Response Rates|10.0||||0.004|TWO_SIDED|95.0|3.2|16.7||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0||16.7|3.2|0.004
70909524|NCT02886728|141307212|SUPERIORITY||Difference in Response Rates|5.5||||0.25|TWO_SIDED|95.0|-2.9|14.0||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0||14.0|-2.9|0.25
70909525|NCT02886728|141307212|SUPERIORITY||Difference in Response Rates|6.5||||0.14|TWO_SIDED|95.0|-2.0|15.0||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0||15.0|-2.0|0.14
71031147|NCT02627924|141570405|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Physical Component Score at Week 12||||<0.0001
71031148|NCT02627924|141570405|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Physical Component Score at Week 24||||<0.0001
71031149|NCT02627924|141570405|OTHER|||||||0.0001|||||||Paired t-test|||Change From Baseline in Mental Component Score at Week 12||||0.0001
71031150|NCT02627924|141570405|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Mental Component Score at Week 24||||<0.0001
71031151|NCT02627924|141570406|OTHER||||||<|0.0001|||||||Paired t-test|||Change from Baseline in EQ-5D-3L at 12 weeks||||<0.0001
71031152|NCT02627924|141570406|OTHER||||||<|0.0001|||||||Paired t-test|||Change from Baseline in EQ-5D-3L at 24 weeks||||<0.0001
71031153|NCT02627924|141570407|OTHER|||||||0.0098|||||||Paired t-test|||Change From Baseline in Overall Work Impairment at Week 12||||0.0098
71031154|NCT02627924|141570407|OTHER|||||||0.0015|||||||Paired t-test|||Change From Baseline in Overall Work Impairment at Week 24||||0.0015
71031155|NCT02627924|141570407|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Activity Impairment at Week 12||||<0.0001
71031156|NCT02627924|141570407|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Activity Impairment at Week 24||||<0.0001
71031157|NCT00528606|141570415|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||p-value based on Cochran-Mantel-Haenszel test comparing treatment groups, stratified by baseline severity group and joint type.||||<0.001
71031158|NCT00959660|141570429|SUPERIORITY||||||<|0.001||||||Main effects analysis with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||||||<0.001
71031159|NCT00959660|141570429|SUPERIORITY||||||<|0.001||||||Main effects analysis with Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||||||<0.001
71031160|NCT00959660|141570430|SUPERIORITY|||||||0.004||||||Main effects analyses with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||||||0.004
71031161|NCT00959660|141570430|SUPERIORITY|||||||0.43||||||Main effects analysis for Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||||||0.43
71031162|NCT00959660|141570431|SUPERIORITY||||||<|0.001||||||Main effects analyses with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Total Body Fat Mass||||<0.001
71031163|NCT00959660|141570431|SUPERIORITY|||||||0.001||||||Main effects analysis of Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Total Body Fat Mass||||0.001
71031164|NCT00959660|141570431|SUPERIORITY||||||<|0.001||||||Main effects analyses with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Total Non-Bone Lean Mass||||<0.001
71092008|NCT01155323|141690597|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.50|Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.15|0.29|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be non-inferior to omafilcon A for quality perceptions.||0.29|-0.15|
71153652|NCT03530124|141799879|SUPERIORITY|The proportion of infants with ≥1 cardiorespiratory event using a Mantel-Haenszel statistic in at the two-sided alpha 0.05 level and corresponding 95% confidence interval.|Odds Ratio (OR)|0.89||||1|TWO_SIDED|95.0|0.29|2.77|||Mantel Haenszel||No adjustments were made to the alpha level (two-sided alpha=0.05) for the secondary objectives.|Only Duke University had viable monitoring data to analyze this compound outcome objective.||2.77|0.29|1.0000
71031165|NCT00959660|141570431|SUPERIORITY|||||||0.25||||||Main effects analysis for Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Total Non-Bone Lean Mass||||0.25
71031166|NCT00959660|141570432|SUPERIORITY||||||<|0.001||||||Main effects analyses with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Thigh Subcutaneous Fat||||<0.001
71031167|NCT00959660|141570432|SUPERIORITY|||||||0.26||||||Main effects analysis for Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Thigh Subcutaneous Fat||||0.26
71031168|NCT00959660|141570432|SUPERIORITY||||||<|0.001||||||Main effects analyses with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Thigh Skeletal Muscle||||<0.001
71031169|NCT00959660|141570432|SUPERIORITY|||||||0.26||||||Main effects analysis of Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Thigh Skeletal Muscle||||0.26
71031170|NCT00050778|141570487|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.24||||0.0006|TWO_SIDED|95.0|0.11|0.545||An alpha-sharing approach was used to adjust for multiple treatment group comparisons, endpoints, and two pre-planned interim analyses, including a Lan-Demets error-spending function. Pre-specified threshold for statistical significance was 0.0165.|Cox Proportional Hazards Regression|||Cox proportional hazards (PH) regression model using treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country) as covariates was used.||0.545|0.110|0.0006
71031171|NCT00050778|141570487|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||0.0021|TWO_SIDED|95.0|0.151|0.658||An alpha-sharing approach was used to adjust for multiple treatment group comparisons, endpoints, and two pre-planned interim analyses, including a Lan-Demets error-spending function. Pre-specified threshold for statistical significance was 0.0165.|Cox Proportional Hazards Regression|||Cox PH regression model using treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country) as covariates was used.||0.658|0.151|0.0021
71031172|NCT00050778|141570487|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.152|0.515|||Cox Proportional Hazards Regression|||Cox PH regression model using treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country) as covariates was used.||0.515|0.152|<0.0001
70909526|NCT02886728|141307212|SUPERIORITY||Difference in Response Rates|7.5||||0.002|TWO_SIDED|95.0|2.8|12.3||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= SDC (1.77)||12.3|2.8|0.002
70909527|NCT02886728|141307212|SUPERIORITY||Difference in Response Rates|8.2||||0.008|TWO_SIDED|95.0|2.9|13.6||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= SDC (1.77)||13.6|2.9|0.008
70909528|NCT02886728|141307212|SUPERIORITY||Difference in Response Rates|2.5||||0.47|TWO_SIDED|95.0|-3.9|8.9||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52 for Change in mTSS \<= SDC (1.77)||8.9|-3.9|0.47
70909529|NCT02886728|141307214|SUPERIORITY||Least Squares Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|0.45|<|0.001|TWO_SIDED|95.0|2.4|4.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.1|2.4|<0.001
70909530|NCT02886728|141307214|SUPERIORITY||Least Squares Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.55||0.001|TWO_SIDED|95.0|0.7|2.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.8|0.7|0.001
70909531|NCT02886728|141307214|SUPERIORITY||Least Squares Mean Difference|2.3|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|1.3|3.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.4|1.3|<0.001
70909532|NCT02886728|141307214|SUPERIORITY||Least Squares Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|0.54|<|0.001|TWO_SIDED|95.0|2.7|4.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.8|2.7|<0.001
70909533|NCT02886728|141307214|SUPERIORITY||Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.66||0.008|TWO_SIDED|95.0|0.5|3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.0|0.5|0.008
71031173|NCT00050778|141570488|SUPERIORITY_OR_OTHER||Rate ratio|0.33|||<|0.0001|TWO_SIDED|95.0|0.196|0.552||An alpha-sharing approach was used to adjust for multiple treatment group comparisons, endpoints, and two pre-planned interim analyses, including a Lan-Demets error-spending function. Pre-specified threshold for statistical significance was 0.0040.|Andersen-Gill Model|||Treatment effects were estimated using an Anderson-Gill multiplicative intensity model with robust variance estimation. Covariates included treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country).||0.552|0.196|<0.0001
71031174|NCT00050778|141570488|SUPERIORITY_OR_OTHER||Rate ratio|0.23|||<|0.0001|TWO_SIDED|95.0|0.126|0.431||An alpha-sharing approach was used to adjust for multiple treatment group comparisons, endpoints, and two pre-planned interim analyses, including a Lan-Demets error-spending function. Pre-specified threshold for statistical significance was 0.0040.|Andersen-Gill Model|||Treatment effects were estimated using an Anderson-Gill multiplicative intensity model with robust variance estimation. Covariates included treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country).||0.431|0.126|<0.0001
70909534|NCT02886728|141307214|SUPERIORITY||Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.66||0.023|TWO_SIDED|95.0|0.2|2.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.8|0.2|0.023
70909535|NCT02886728|141307214|SUPERIORITY||Least Squares Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.59||0.003|TWO_SIDED|95.0|0.6|2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.9|0.6|0.003
70909536|NCT02886728|141307214|SUPERIORITY||Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.71||0.38|TWO_SIDED|95.0|-0.8|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-0.8|0.38
71031175|NCT00050778|141570488|SUPERIORITY_OR_OTHER||Rate ratio|0.28|||<|0.0001|TWO_SIDED|95.0|0.176|0.441|||Andersen-Gill Model|||Treatment effects were estimated using an Anderson-Gill multiplicative intensity model with robust variance estimation. Covariates included treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country).||0.441|0.176|<0.0001
71031176|NCT00050778|141570489|SUPERIORITY_OR_OTHER||Treatment effect|62.64||||0.0001|||||||Cox Proportional Hazards Regression|||Cox PH regression model with treatment group indicator, Baseline EDSS and country as covariates was used.||||0.0001
71031177|NCT00050778|141570489|SUPERIORITY_OR_OTHER||Treatment effect|76.71|||<|0.0001|||||||Cox Proportional Hazards Regression|||Cox PH regression model with treatment group indicator, Baseline EDSS and country as covariates was used.||||<0.0001
71031178|NCT00050778|141570489|SUPERIORITY_OR_OTHER||Treatment effect|70.13|||<|0.0001|||||||Cox Proportional Hazards Regression|||Cox PH regression model with treatment group indicator, Baseline EDSS and country as covariates was used.||||<0.0001
71031179|NCT00050778|141570490|SUPERIORITY_OR_OTHER|||||||0.0885|||||||ANCOVA|||Ranked analysis of covariance (ANCOVA) model using Baseline MRI-T1 brain volume, EDSS group, country, and treatment as covariates was used.||||0.0885
71031180|NCT00050778|141570490|SUPERIORITY_OR_OTHER|||||||0.0195|||||||ANCOVA|||Ranked ANCOVA model using Baseline MRI-T1 brain volume, EDSS group, country, and treatment as covariates was used.||||0.0195
71031181|NCT00050778|141570490|SUPERIORITY_OR_OTHER|||||||0.0215|||||||ANCOVA|||Ranked ANCOVA model using Baseline MRI-T1 brain volume, EDSS group, country, and treatment as covariates was used.||||0.0215
71031182|NCT00050778|141570491|SUPERIORITY_OR_OTHER|||||||0.3077|||||||ANCOVA|||Ranked ANCOVA model using Baseline MRI-T2 lesion volume, EDSS group, country, and treatment as covariates was used.||||0.3077
71031183|NCT00050778|141570491|SUPERIORITY_OR_OTHER|||||||0.3632|||||||ANCOVA|||Ranked ANCOVA model using Baseline MRI-T2 lesion volume, EDSS group, country, and treatment as covariates was used.||||0.3632
71031184|NCT00050778|141570491|SUPERIORITY_OR_OTHER|||||||0.2758|||||||ANCOVA|||Ranked ANCOVA model using Baseline MRI-T2 lesion volume, EDSS group, country, and treatment as covariates was used.||||0.2758
71031185|NCT00813293|141570512|SUPERIORITY|||||||0.794|||||||Wilcoxon (Mann-Whitney)|||Assuming the two trial arms were independent, the standard deviation was 0.5cm for both arms and a sample size of 16 evaluable patients (8 per arm), the study had an 84% power at a 5% (two-sided) significance level to detect 0.8cm difference in ablation zone size. In order to allow a 20% drop-out rate, a total of 20 subjects were accrued.||||.794
71031186|NCT01536405|141570531|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% confidence interval (CI) on the risk difference excluding a decrease \>= the prespecified criterion of 10 percentage points|Risk Difference (RD)|4.2|||<|0.001|TWO_SIDED|95.0|1.8|6.8|||Miettinen and Nurminen||RD = MMRV (AMP) - MMRV (2006 process)|||6.8|1.8|<0.001
71031187|NCT01536405|141570531|SUPERIORITY_OR_OTHER||Response rate|97.3|||<|0.001|TWO_SIDED|95.0|95.6|98.4|||One-sample binomial|||Acceptability of the antibody response rate was based on a lower bound of the 95% CI being \>76%||98.4|95.6|<0.001
71031188|NCT01536405|141570532|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease \>= the prespecified criterion of 5 percentage points|Risk Difference (RD)|-2.2||||0.003|TWO_SIDED|95.0|-4.0|-0.6|||Miettinen and Nurminen||RD = MMRV (AMP) - MMRV (2006 process)|||-0.6|-4.0|0.003
71031189|NCT01536405|141570532|SUPERIORITY_OR_OTHER||Response rate|96.7|||<|0.001|TWO_SIDED|95.0|94.9|97.9|||One-sample binomial|||Acceptability of the antibody response rate was based on a lower bound of the 95% CI being \>90%||97.9|94.9|<0.001
71031190|NCT01536405|141570533|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease \>= the prespecified criterion of 5 percentage points|Risk Difference (RD)|1.0|||<|0.001|TWO_SIDED|95.0|-0.7|2.8|||Miettinen and Nurminen||RD = MMRV (AMP) - MMRV (2006 process)|||2.8|-0.7|<0.001
71031191|NCT01536405|141570533|SUPERIORITY_OR_OTHER||Response rate|98.2|||<|0.001|TWO_SIDED|95.0|96.8|99.1|||One-sample binomial|||Acceptability of the antibody response rate was based on a lower bound of the 95% CI being \>90%||99.1|96.8|<0.001
71031192|NCT01536405|141570534|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease \>= the prespecified criterion of 5 percentage points|Risk Difference (RD)|-0.5|||<|0.001|TWO_SIDED|95.0|-1.8|0.7|||Miettinen and Nurminen||RD = MMRV (AMP) - MMRV (2006 process)|||0.7|-1.8|<0.001
71031193|NCT01536405|141570534|SUPERIORITY_OR_OTHER||Response rate|98.8|||<|0.001|TWO_SIDED|95.0|97.6|99.5|||One-sample binomial|||Acceptability of the antibody response rate was based on a lower bound of the 95% CI being \>90%||99.5|97.6|<0.001
71031194|NCT01536405|141570535|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the GMT ratio, excluding a decrease of \>=1.5 fold|GMT ratio|1.2|||<|0.001|TWO_SIDED|95.0|1.1|1.3|||t-test, 2 sided|Analysis was based on log-transformed titers|GMT ratio = MMRV (AMP) / MMRV (2006 process)|||1.3|1.1|<0.001
71031195|NCT01536405|141570536|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the GMT ratio, excluding a decrease of \>=1.5 fold|GMT ratio|0.9|||<|0.001|TWO_SIDED|95.0|0.8|1.0|||t-test, 2 sided|Analysis was based on log-transformed titers|GMT ratio = MMRV (AMP) / MMRV (2006 process)|||1.0|0.8|<0.001
71031196|NCT01536405|141570537|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the GMT ratio, excluding a decrease of \>=1.5 fold|GMT ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.9|1.1|||t-test, 2 sided|Analysis was based on log-transformed titers|GMT ratio = MMRV (AMP) / MMRV (2006 process)|||1.1|0.9|<0.001
71031197|NCT01536405|141570538|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the GMT ratio, excluding a decrease of \>=1.5 fold|GMT ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.9|1.1|||t-test, 2 sided|Analysis was based on log-transformed titers|GMT ratio = MMRV (AMP) / MMRV (2006 process)|||1.1|0.9|<0.001
71031198|NCT01536405|141570539|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.2|||<|0.001|TWO_SIDED|95.0|-1.0|1.3|||Miettinen and Nurminen||RD = MMRV (AMP) - MMRV (2006 process)|||1.3|-1.0|<0.001
70909537|NCT02886728|141307214|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.72||0.59|TWO_SIDED|95.0|-1.0|1.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.8|-1.0|0.59
70909538|NCT02886728|141307214|SUPERIORITY||Least Squares Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|1.6|4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.0|1.6|<0.001
70909539|NCT02886728|141307214|SUPERIORITY||Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.76||0.11|TWO_SIDED|95.0|-0.3|2.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.7|-0.3|0.11
70909540|NCT02886728|141307214|SUPERIORITY||Least Squares Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.76||0.071|TWO_SIDED|95.0|-0.17|2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.9|-0.17|0.071
70909541|NCT02886728|141307216|SUPERIORITY||Least Squares Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|95.0|1.6|3.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.8|1.6|<0.001
70909542|NCT02886728|141307216|SUPERIORITY||Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.7||0.032|TWO_SIDED|95.0|0.1|2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.9|0.1|0.032
70909543|NCT02886728|141307216|SUPERIORITY||Least Squares Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|1.0|3.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.8|1.0|<0.001
70909544|NCT02886728|141307216|SUPERIORITY||Least Squares Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.6||0.023|TWO_SIDED|95.0|0.2|2.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.6|0.2|0.023
70909545|NCT02886728|141307216|SUPERIORITY||Least Squares Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.74||0.065|TWO_SIDED|95.0|-0.1|2.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.8|-0.1|0.065
70909546|NCT02886728|141307216|SUPERIORITY||Least Squares Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.74||0.15|TWO_SIDED|95.0|-0.4|2.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.5|-0.4|0.15
70909547|NCT02886728|141307216|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.64||0.73|TWO_SIDED|95.0|-1.0|1.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.5|-1.0|0.73
70909548|NCT02886728|141307216|SUPERIORITY||Least Squares Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.78||0.37|TWO_SIDED|95.0|-0.8|2.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.2|-0.8|0.37
71092009|NCT01155323|141690598|NON_INFERIORITY_OR_EQUIVALENCE|Margin = +/- 0.50|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.01|0.06|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be equivalent to omafilcon A from limbal hyperemia.||0.06|-0.01|
70909549|NCT02886728|141307216|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.78||0.83|TWO_SIDED|95.0|-1.7|1.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.4|-1.7|0.83
70909550|NCT02886728|141307216|SUPERIORITY||Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.66||0.073|TWO_SIDED|95.0|-0.1|2.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.5|-0.1|0.073
70909551|NCT02886728|141307216|SUPERIORITY||Least Squares Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.8||0.09|TWO_SIDED|95.0|-0.2|2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.9|-0.2|0.090
70909552|NCT02886728|141307216|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.81||0.68|TWO_SIDED|95.0|-1.9|1.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.2|-1.9|0.68
70909553|NCT02886728|141307216|SUPERIORITY||Least Squares Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.67||0.3|TWO_SIDED|95.0|-0.6|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-0.6|0.30
70909554|NCT02886728|141307216|SUPERIORITY||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.82||0.69|TWO_SIDED|95.0|-1.3|1.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.9|-1.3|0.69
70909555|NCT02886728|141307216|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.82||0.95|TWO_SIDED|95.0|-1.7|1.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.5|-1.7|0.95
70909556|NCT02886728|141307218|SUPERIORITY||Least Squares Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|0.58|<|0.001|TWO_SIDED|95.0|2.1|4.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.4|2.1|<0.001
70909557|NCT02886728|141307218|SUPERIORITY||Least Squares Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|1.1|3.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.9|1.1|<0.001
70909558|NCT02886728|141307218|SUPERIORITY||Least Squares Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|0.71|<|0.001|TWO_SIDED|95.0|1.3|4.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.1|1.3|<0.001
71092010|NCT04154956|141690611|SUPERIORITY||Hazard Ratio (HR)|1.143||||0.8204|TWO_SIDED|95.0|0.864|1.512||One-sided significance level was 0.01|Log Rank||Hazard ratio and confidence intervals (CIs) were computed from a stratified Cox model according to stratification factors as per IRT.|||1.512|0.864|0.8204
70909559|NCT02886728|141307218|SUPERIORITY||Least Squares Mean Difference|2.2|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|1.0|3.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.5|1.0|<0.001
70909560|NCT02886728|141307218|SUPERIORITY||Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.78||0.13|TWO_SIDED|95.0|-0.4|2.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.7|-0.4|0.13
70909561|NCT02886728|141307218|SUPERIORITY||Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.79||0.032|TWO_SIDED|95.0|0.1|3.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.2|0.1|0.032
70909562|NCT02886728|141307218|SUPERIORITY||Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.67||0.028|TWO_SIDED|95.0|0.2|2.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.8|0.2|0.028
70909563|NCT02886728|141307218|SUPERIORITY||Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.81||0.15|TWO_SIDED|95.0|-0.4|2.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.7|-0.4|0.15
70909564|NCT02886728|141307218|SUPERIORITY||Least Squares Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.81||0.41|TWO_SIDED|95.0|-0.9|2.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.3|-0.9|0.41
70909565|NCT02886728|141307218|SUPERIORITY||Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.71||0.017|TWO_SIDED|95.0|0.3|3.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.1|0.3|0.017
70909566|NCT02886728|141307218|SUPERIORITY||Least Squares Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.86||0.27|TWO_SIDED|95.0|-0.7|2.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.6|-0.7|0.27
70909567|NCT02886728|141307218|SUPERIORITY||Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.87||0.15|TWO_SIDED|95.0|-0.5|2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.9|-0.5|0.15
70909568|NCT02886728|141307221|SUPERIORITY||Least Squares Mean Difference|9.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|6.0|12.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||12.0|6.0|<0.001
70909569|NCT02886728|141307221|SUPERIORITY||Least Squares Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|1.6||0.006|TWO_SIDED|95.0|1.0|8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||8.0|1.0|0.006
70909570|NCT02886728|141307221|SUPERIORITY||Least Squares Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|3.0|9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||9.0|3.0|<0.001
70909571|NCT02886728|141307221|SUPERIORITY||Least Squares Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|2.0|8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||8.0|2.0|<0.001
70909572|NCT02886728|141307221|SUPERIORITY||Least Squares Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|1.8||0.089|TWO_SIDED|95.0|0.0|7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||7.0|-0.0|0.089
70909573|NCT02886728|141307221|SUPERIORITY||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.9||0.18|TWO_SIDED|95.0|-1.0|6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||6.0|-1.0|0.18
71031199|NCT01371786|141570549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.92|||||TWO_SIDED|95.0|-21.76|-4.09||No formal statistical testing was conducted. Only descriptive statistics were calculated and presented.|||Difference calculated as Mometasone minus Ciclesonide|No formal null hypothesis was stated or tested.Descriptive statistics only were calculated and presented. The sample size was determined outside of statistical considerations. The sample size of 10 subjects was sufficient to provide approximately 80% power to detect a difference of 25% between the two treatment groups in the percentage of nasal deposition approximately 2 minutes post dose, assuming a two-sided test evaluated at a significance level of 0.05, with a SD of the difference of 23.17%.||-4.09|-21.76|
71031200|NCT02549092|141570554|SUPERIORITY||Least Squares (LS) Mean of Difference|-8.21|STANDARD_ERROR_OF_MEAN|9.91||0.41|TWO_SIDED|95.0|-27.98|11.55||P value is from the mixed model repeated measures (MMRM) with the model: change from Baseline=treatment, country, visit, Baseline, treatment-by-visit, and Baseline-by-visit. Unstructured variance-covariance structure was used in the MMRM analysis.|mixed model repeated measures|Adjusted for multiplicity using the Hochberg procedure to control the family-wise error rate at a pre-specified significance level (alpha = 0.05).|Difference of LCIG - OMT|||11.55|-27.98|0.410
71031201|NCT02549092|141570555|SUPERIORITY||LS Mean of Difference|1.57|STANDARD_ERROR_OF_MEAN|2.37||0.509|TWO_SIDED|95.0|-3.16|6.3||The P value is from the MMRM with the model: change from Baseline = treatment, country, visit, Baseline, treatment-by-visit, and Baseline-by-visit. The unstructured variance-covariance structure was used in the MMRM analysis.|mixed model repeated measures|Adjusted for multiplicity using the Hochberg procedure to control the family-wise error rate at a pre-specified significance level (alpha = 0.05).|Difference of LCIG - OMT|||6.30|-3.16|0.509
71031202|NCT02549092|141570556|SUPERIORITY||LS mean difference|-3.81|STANDARD_ERROR_OF_MEAN|3.59||0.291|TWO_SIDED|95.0|-10.96|3.34||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Statistical significance for the 3 key secondary efficacy endpoints (PDQ-8 index score, CGI-C score, and UPDRS Part II) could only be evaluated using the Hochberg procedure for multiplicity control if both primary endpoints had been statistically significant after multiplicity adjustment.||3.34|-10.96|0.291
71031203|NCT02549092|141570557|SUPERIORITY||LS Mean of Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.84|-1.82||Analysis of covariance (ANCOVA) model: FINAL = treatment, country.|ANCOVA||Difference of LCIG - OMT|Statistical significance for the 3 key secondary efficacy endpoints (PDQ-8 index score, CGI-C score, and UPDRS Part II) could only be evaluated using the Hochberg procedure for multiplicity control if both primary endpoints had been statistically significant after multiplicity adjustment.||-1.82|-2.84|< 0.001
71031204|NCT02549092|141570558|SUPERIORITY||LS mean difference|-2.79|STANDARD_ERROR_OF_MEAN|0.99||0.006|TWO_SIDED|95.0|-4.77|-0.81||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Statistical significance for the 3 key secondary efficacy endpoints (PDQ-8 index score, CGI-C score, and UPDRS Part II) could only be evaluated using the Hochberg procedure for multiplicity control if both primary endpoints had been statistically significant after multiplicity adjustment.||-0.81|-4.77|0.006
71031205|NCT02549092|141570559|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.99||0.933|TWO_SIDED|95.0|-1.89|2.06||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Cardiovascular including falls||2.06|-1.89|0.933
71031206|NCT02549092|141570559|SUPERIORITY||LS mean difference|1.05|STANDARD_ERROR_OF_MEAN|2.35||0.655|TWO_SIDED|95.0|-3.63|5.74||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Sleep/fatigue||5.74|-3.63|0.655
71031207|NCT02549092|141570559|SUPERIORITY||LS mean difference|-1.85|STANDARD_ERROR_OF_MEAN|3.67||0.616|TWO_SIDED|95.0|-9.18|5.48||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Mood/cognition||5.48|-9.18|0.616
71031208|NCT02549092|141570559|SUPERIORITY||LS mean difference|0.39|STANDARD_ERROR_OF_MEAN|0.84||0.645|TWO_SIDED|95.0|-1.3|2.08||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Perceptual problems/hallucinations||2.08|-1.30|0.645
71031209|NCT02549092|141570559|SUPERIORITY||LS mean difference|-0.94|STANDARD_ERROR_OF_MEAN|2.04||0.645|TWO_SIDED|95.0|-5.03|3.14||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Attention/memory||3.14|-5.03|0.645
71031210|NCT02549092|141570559|SUPERIORITY||LS mean difference|-2.58|STANDARD_ERROR_OF_MEAN|1.34||0.058|TWO_SIDED|95.0|-5.25|0.09||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Gastrointestinal tract||0.09|-5.25|0.058
71031211|NCT02549092|141570559|SUPERIORITY||LS mean difference|-1.18|STANDARD_ERROR_OF_MEAN|2.17||0.588|TWO_SIDED|95.0|-5.52|3.15||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Urinary||3.15|-5.52|0.588
71031212|NCT02549092|141570559|SUPERIORITY||LS mean difference|-0.78|STANDARD_ERROR_OF_MEAN|1.05||0.464|TWO_SIDED|95.0|-2.88|1.33||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Sexual function||1.33|-2.88|0.464
71092011|NCT04154956|141690612|SUPERIORITY||Hazard Ratio (HR)|0.846||||0.112|TWO_SIDED|95.0|0.644|1.109||One-sided significance level was 0.00174.|Log Rank||Hazard ratio and CIs were computed from a stratified Cox model according to stratification factors as per IRT.|||1.109|0.644|0.1120
70909574|NCT02886728|141307221|SUPERIORITY||Least Squares Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|1.5||0.003|TWO_SIDED|95.0|1.0|7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||7.0|1.0|0.003
70909575|NCT02886728|141307221|SUPERIORITY||Least Squares Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|1.8||0.049|TWO_SIDED|95.0|0.0|7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||7.0|0.0|0.049
70909576|NCT02886728|141307221|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.8||0.84|TWO_SIDED|95.0|-4.0|3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.0|-4.0|0.84
70909577|NCT02886728|141307221|SUPERIORITY||Least Squares Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|2.0|9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||9.0|2.0|<0.001
70909578|NCT02886728|141307221|SUPERIORITY||Least Squares Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|2.0||0.078|TWO_SIDED|95.0|0.0|7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||7.0|-0.0|0.078
70909579|NCT02886728|141307221|SUPERIORITY||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|2.0||0.39|TWO_SIDED|95.0|-2.0|6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||6.0|-2.0|0.39
70909580|NCT02886728|141307221|SUPERIORITY||Least Squares Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|1.7||0.004|TWO_SIDED|95.0|2.0|8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||8.0|2.0|0.004
70909581|NCT02886728|141307221|SUPERIORITY||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|2.1||0.45|TWO_SIDED|95.0|-3.0|6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||6.0|-3.0|0.45
70909582|NCT02886728|141307221|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|2.1||0.85|TWO_SIDED|95.0|-4.0|5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.0|-4.0|0.85
70909583|NCT02118714|141307241|OTHER||Percentage of Participants|23.5|||||TWO_SIDED|80.0|10.7|41.6||||||||41.6|10.7|
70909584|NCT02118714|141307241|OTHER||Percentage of Participants|23.5|||||TWO_SIDED|95.0|6.8|49.9||||||||49.9|6.8|
70909585|NCT02118714|141307242|OTHER||Percentage of Participants|11.8|||||TWO_SIDED|80.0|3.2|28.4||||||||28.4|3.2|
70909586|NCT02118714|141307242|OTHER||Percentage of Participants|11.8|||||TWO_SIDED|95.0|1.5|36.4||||||||36.4|1.5|
70909587|NCT04227340|141307265|OTHER|The count, percentage and confidence interval will be calculated for allogeneic HCT patients who receive PBM and develop Grade 3 mucositis|Odds Ratio (OR)|0.2|||||TWO_SIDED|95.0|0.091|0.356|||||Odds of grade 3 in Allogeneic group compared to historical rates. The study efficacy of mucositis reduction by 20% with an estimation of 51% developing grade 3 mucositis.|The count, percentage and confidence interval were calculated for allogeneic HCT participants who receive PBM and developed Grade 3 mucositis. Whether the percentage of the prospective sample is significantly different from the estimated rate of 71% was accessed.||0.356|0.091|
70909588|NCT04227340|141307266|SUPERIORITY|||||||0.03|||||||Wilcox Rank Sum|||||||0.03
70909589|NCT04227340|141307268|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
70909590|NCT04227340|141307270|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
70909591|NCT04227340|141307272|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||0.1
70909592|NCT04227340|141307274|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
70909593|NCT03486899|141307292|SUPERIORITY||Odds Ratio (OR)|2.65||||0.055|TWO_SIDED|95.0|0.88|8.52|||Cochran-Mantel-Haenszel|||||8.52|0.88|0.055
70909594|NCT03486899|141307292|SUPERIORITY||Odds Ratio (OR)|1.89||||0.245|TWO_SIDED|95.0|0.61|6.27|||Cochran-Mantel-Haenszel|||||6.27|0.61|0.245
70909595|NCT03486899|141307292|SUPERIORITY||Odds Ratio (OR)|2.17||||0.129|TWO_SIDED|95.0|0.71|7.1|||Cochran-Mantel-Haenszel|||||7.10|0.71|0.129
70909596|NCT03486899|141307293|SUPERIORITY||Odds Ratio (OR)|2.2||||0.214|TWO_SIDED|95.0|0.53|10.64|||Cochran-Mantel-Haenszel|||||10.64|0.53|0.214
70909597|NCT03486899|141307293|SUPERIORITY||Odds Ratio (OR)|1.83||||0.381|TWO_SIDED|95.0|0.43|9.1|||Cochran-Mantel-Haenszel|||||9.10|0.43|0.381
70909598|NCT03486899|141307293|SUPERIORITY||Odds Ratio (OR)|2.88||||0.079|TWO_SIDED|95.0|0.75|13.48|||Cochran-Mantel-Haenszel|||||13.48|0.75|0.079
70909599|NCT03486899|141307294|SUPERIORITY||Odds Ratio (OR)|2.07||||0.18|TWO_SIDED|95.0|0.63|7.47|||Cochran-Mantel-Haenszel|||||7.47|0.63|0.180
70909600|NCT03486899|141307294|SUPERIORITY||Odds Ratio (OR)|1.37||||0.612|TWO_SIDED|95.0|0.38|5.2|||Cochran-Mantel-Haenszel|||||5.20|0.38|0.612
70909601|NCT03486899|141307294|SUPERIORITY||Odds Ratio (OR)|2.59||||0.079|TWO_SIDED|95.0|0.81|9.1|||Cochran-Mantel-Haenszel|||||9.10|0.81|0.079
70909602|NCT03486899|141307295|SUPERIORITY||Odds Ratio (OR)|0.39||||0.038|TWO_SIDED|95.0|0.15|1.03|||Cochran-Mantel-Haenszel|||||1.03|0.15|0.038
70909603|NCT03486899|141307295|SUPERIORITY||Odds Ratio (OR)|0.6||||0.256|TWO_SIDED|95.0|0.22|1.57|||Cochran-Mantel-Haenszel|||||1.57|0.22|0.256
70909604|NCT03486899|141307295|SUPERIORITY||Odds Ratio (OR)|0.65||||0.296|TWO_SIDED|95.0|0.25|1.73|||Cochran-Mantel-Haenszel|||||1.73|0.25|0.296
70909605|NCT03486899|141307296|SUPERIORITY||Odds Ratio (OR)|1.36||||0.718|TWO_SIDED|95.0|0.22|9.8|||Cochran-Mantel-Haenszel|||||9.80|0.22|0.718
70909606|NCT03486899|141307296|SUPERIORITY||Odds Ratio (OR)|0.64||||0.632|TWO_SIDED|95.0|0.05|5.87|||Cochran-Mantel-Haenszel|||||5.87|0.05|0.632
70909607|NCT03486899|141307296|SUPERIORITY||Odds Ratio (OR)|0.32||||0.293|TWO_SIDED|95.0|0.01|4.19|||Cochran-Mantel-Haenszel|||||4.19|0.01|0.293
70909608|NCT03486899|141307297|SUPERIORITY||Odds Ratio (OR)|1.36||||0.718|TWO_SIDED|95.0|0.22|9.8|||Cochran-Mantel-Haenszel|||||9.80|0.22|0.718
70909609|NCT03486899|141307297|SUPERIORITY||Odds Ratio (OR)|0.64||||0.632|TWO_SIDED|95.0|0.05|5.87|||Cochran-Mantel-Haenszel|||||5.87|0.05|0.632
70909610|NCT03486899|141307297|SUPERIORITY||Odds Ratio (OR)|0.32||||0.293|TWO_SIDED|95.0|0.01|4.19|||Cochran-Mantel-Haenszel|||||4.19|0.01|0.293
70909611|NCT03486899|141307298|SUPERIORITY||Odds Ratio (OR)|2.55||||0.101|TWO_SIDED|95.0|0.73|10.12|||Cochran-Mantel-Haenszel|||||10.12|0.73|0.101
70909612|NCT03486899|141307298|SUPERIORITY||Odds Ratio (OR)|1.43||||0.587|TWO_SIDED|95.0|0.36|6.17|||Cochran-Mantel-Haenszel|||||6.17|0.36|0.587
70909613|NCT03486899|141307298|SUPERIORITY||Odds Ratio (OR)|1.72||||0.371|TWO_SIDED|95.0|0.45|7.2|||Cochran-Mantel-Haenszel|||||7.20|0.45|0.371
70909614|NCT03486899|141307299|SUPERIORITY||Odds Ratio (OR)|2.2||||0.214|TWO_SIDED|95.0|0.53|10.64|||Cochran-Mantel-Haenszel|||||10.64|0.53|0.214
70909615|NCT03486899|141307299|SUPERIORITY||Odds Ratio (OR)|1.83||||0.381|TWO_SIDED|95.0|0.43|9.1|||Cochran-Mantel-Haenszel|||||9.10|0.43|0.381
70909616|NCT03486899|141307299|SUPERIORITY||Odds Ratio (OR)|2.2||||0.214|TWO_SIDED|95.0|0.53|10.64|||Cochran-Mantel-Haenszel|||||10.64|0.53|0.214
70909617|NCT03486899|141307300|SUPERIORITY||Odds Ratio (OR)|2.85||||0.06|TWO_SIDED|95.0|0.83|11.21|||Cochran-Mantel-Haenszel|||||11.21|0.83|0.060
70909618|NCT03486899|141307300|SUPERIORITY||Odds Ratio (OR)|1.93||||0.276|TWO_SIDED|95.0|0.53|7.92|||Cochran-Mantel-Haenszel|||||7.92|0.53|0.276
70909619|NCT03486899|141307300|SUPERIORITY||Odds Ratio (OR)|1.72||||0.371|TWO_SIDED|95.0|0.45|7.2|||Cochran-Mantel-Haenszel|||||7.20|0.45|0.371
70909620|NCT03486899|141307301|SUPERIORITY||Odds Ratio (OR)|1.72||||0.242|TWO_SIDED|95.0|0.62|4.87|||Cochran-Mantel-Haenszel|||||4.87|0.62|0.242
70909621|NCT03486899|141307301|SUPERIORITY||Odds Ratio (OR)|1.1||||0.803|TWO_SIDED|95.0|0.37|3.26|||Cochran-Mantel-Haenszel|||||3.26|0.37|0.803
70909622|NCT03486899|141307301|SUPERIORITY||Odds Ratio (OR)|1.56||||0.35|TWO_SIDED|95.0|0.56|4.46|||Cochran-Mantel-Haenszel|||||4.46|0.56|0.350
70909623|NCT01782326|141307312|NON_INFERIORITY_OR_EQUIVALENCE|Study was designed to have \>95% power to rule out a 1.15-fold increase in the rate exacerbations for QVA149 vs. salmeterol/fluticasone.|Rate Ratio|0.89|||||TWO_SIDED|95.0|0.83|0.96|||Generalized linear model||If the upper limit of the confidence interval was \<1.15 then non-inferiority of QVA149 compared to SFC could be claimed|||0.96|0.83|
70909624|NCT01782326|141307312|SUPERIORITY_OR_OTHER||Rate Ratio|0.89||||0.003|TWO_SIDED|95.0|0.83|0.96|||Generalized linear method||If non-inferiority was demonstrated, superiority of QVA149A compared to SFC in reducing exacerbation rate could be claimed if the upper limit of the same CI was less than 1.|||0.96|0.83|0.003
70909625|NCT01782326|141307313|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84|||<|0.001|TWO_SIDED|95.0|0.78|0.91|||Regression, Cox|||||0.91|0.78|<0.001
70909626|NCT01782326|141307314|SUPERIORITY_OR_OTHER||Rate Ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.75|0.91|||Generalized linear model|||||0.91|0.75|<0.001
70909627|NCT01782326|141307315|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78|||<|0.001|TWO_SIDED|95.0|0.7|0.86|||Regression, Cox|||||0.86|0.70|<0.001
70909628|NCT01782326|141307320|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.256|TWO_SIDED|95.0|0.74|1.08|||Regression, Cox|||||1.08|0.74|0.256
70909629|NCT01782326|141307321|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.008|TWO_SIDED|95.0|0.69|0.95|||Regression, Cox|||||0.95|0.69|0.008
70909630|NCT01782326|141307322|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.046|TWO_SIDED|95.0|0.66|1.0|||Regression, Cox|||||1.00|0.66|0.046
70909631|NCT01782326|141307323|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.79|TWO_SIDED|95.0|0.38|2.1|||Regression, Cox|||||2.10|0.38|0.790
70909632|NCT04033991|141307351|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
70909633|NCT04033991|141307351|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
70909634|NCT04033991|141307352|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
70909635|NCT04033991|141307352|OTHER|||||||0.0068|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||0.0068
70909636|NCT04033991|141307354|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
70909637|NCT04033991|141307354|OTHER|||||||0.0004|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||0.0004
70909638|NCT04033991|141307355|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
70909639|NCT04033991|141307355|OTHER|||||||0.0014|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||0.0014
70909640|NCT04033991|141307360|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
70909641|NCT04033991|141307360|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
71031213|NCT02549092|141570559|SUPERIORITY||LS mean difference|-1.29|STANDARD_ERROR_OF_MEAN|1.76||0.468|TWO_SIDED|95.0|-4.8|2.23||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Miscellaneous||2.23|-4.80|0.468
71031214|NCT02549092|141570560|SUPERIORITY||LS Mean of Difference|-0.58|STANDARD_ERROR_OF_MEAN|1.26||0.643|TWO_SIDED|95.0|-3.09|1.92||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Motor symptoms at night||1.92|-3.09|0.643
71031215|NCT02549092|141570560|SUPERIORITY||LS Mean of Difference|0.24|STANDARD_ERROR_OF_MEAN|0.82||0.769|TWO_SIDED|95.0|-1.39|1.87||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|PD symptoms at night||1.87|-1.39|0.769
71031216|NCT02549092|141570560|SUPERIORITY||LS Mean of Difference|1.99|STANDARD_ERROR_OF_MEAN|0.84||0.02|TWO_SIDED|95.0|0.32|3.66||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Disturbed sleep||3.66|0.32|0.020
71031217|NCT02549092|141570561|SUPERIORITY||LS Mean of Difference|0.19|STANDARD_ERROR_OF_MEAN|0.46||0.672|TWO_SIDED|95.0|-0.72|1.1||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Part I score||1.10|-0.72|0.672
71031218|NCT02549092|141570561|SUPERIORITY||LS Mean of Difference|-2.22|STANDARD_ERROR_OF_MEAN|2.13||0.302|TWO_SIDED|95.0|-6.47|2.04||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Part III score||2.04|-6.47|0.302
71031219|NCT02549092|141570561|SUPERIORITY||LS Mean of Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.61||0.007|TWO_SIDED|95.0|-2.91|-0.48||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Part IV score||-0.48|-2.91|0.007
71031220|NCT02549092|141570562|SUPERIORITY||LS Mean of Difference|-1.54|STANDARD_ERROR_OF_MEAN|1.5||0.307|TWO_SIDED|95.0|-4.52|1.44||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|||1.44|-4.52|0.307
71031221|NCT02549092|141570563|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.46||0.868|TWO_SIDED|95.0|-0.99|0.84||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|||0.84|-0.99|0.868
71031222|NCT02549092|141570564|SUPERIORITY||LS Mean of Difference|-1.14|STANDARD_ERROR_OF_MEAN|3.28||0.728|TWO_SIDED|95.0|-7.68|5.39||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Total score||5.39|-7.68|0.728
70909642|NCT04033991|141307361|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
70909643|NCT04033991|141307361|OTHER|||||||0.0094|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||0.0094
70909644|NCT00738530|141307376|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.336|TWO_SIDED|95.0|0.76|1.1|||Log Rank|||||1.10|0.76|0.3360
70909645|NCT00738530|141307378|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.0004|TWO_SIDED|95.0|0.64|0.88|||Log Rank|||||0.88|0.64|0.0004
70909646|NCT00738530|141307379|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0002|TWO_SIDED|95.0|0.62|0.86|||Log Rank|||||0.86|0.62|0.0002
70909647|NCT00738530|141307381|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0023|TWO_SIDED|95.0|0.66|0.92|||Log Rank|||||0.92|0.66|0.0023
70909648|NCT00738530|141307382|SUPERIORITY_OR_OTHER||Difference in response rates|19.9|||<|0.0001|TWO_SIDED|95.0|13.2|26.6|||Chi-squared|||||26.6|13.2|<.0001
71031223|NCT02549092|141570564|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.71||0.916|TWO_SIDED|95.0|-1.5|1.35||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Musculoskeletal pain score||1.35|-1.50|0.916
71031224|NCT02549092|141570564|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.68||0.919|TWO_SIDED|95.0|-1.28|1.42||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Chronic pain score||1.42|-1.28|0.919
71031225|NCT02549092|141570564|SUPERIORITY||LS Mean of Difference|0.63|STANDARD_ERROR_OF_MEAN|1.53||0.68|TWO_SIDED|95.0|-2.42|3.68||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Fluctuation related pain score||3.68|-2.42|0.680
71031226|NCT02549092|141570564|SUPERIORITY||LS Mean of Difference|-0.37|STANDARD_ERROR_OF_MEAN|1.24||0.767|TWO_SIDED|95.0|-2.83|2.09||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Nocturnal pain score||2.09|-2.83|0.767
71031227|NCT02549092|141570564|SUPERIORITY||LS Mean of Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.51||0.804|TWO_SIDED|95.0|-1.15|0.9||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Orofacial pain score||0.90|-1.15|0.804
71031228|NCT02549092|141570564|SUPERIORITY||LS Mean of Difference|-1.81|STANDARD_ERROR_OF_MEAN|0.79||0.025|TWO_SIDED|95.0|-3.38|-0.23||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Discoloration and edema score||-0.23|-3.38|0.025
71031229|NCT02549092|141570564|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.47||0.93|TWO_SIDED|95.0|-0.99|0.9||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Radicular pain score||0.90|-0.99|0.930
71031230|NCT02549092|141570565|SUPERIORITY||LS Mean of Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.89|-1.87||ANCOVA model: FINAL = treatment, country.|ANCOVA||Difference of LCIG - OMT|||-1.87|-2.89|< 0.001
71031231|NCT02511782|141570566|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71031232|NCT02511782|141570567|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71031233|NCT03611608|141570582|SUPERIORITY||Mean Difference (Final Values)|263.54|||<|0.001|ONE_SIDED|90.0|207.86||||t-test, 1 sided||||||207.86|<0.001
71031234|NCT02158494|141570585|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||P-Value for Sensory Organization Test results at 2 weeks||||0.41
71031235|NCT02158494|141570585|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||P-Value for Sensory Organization Test results at 14 weeks||||0.47
71031236|NCT02158494|141570585|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||P-Value for Sensory Organization Test results at 26 weeks||||0.99
71031237|NCT04753437|141570638|EQUIVALENCE|Results were based on analysis of variance model with treatment as a fixed effect.|Geometric Least Squares (LS) Mean Ratio|1.3|||||TWO_SIDED|90.0|0.94|1.81||||||||1.81|0.94|
71031238|NCT04753437|141570639|EQUIVALENCE|Results were based on analysis of variance model with treatment as a fixed effect.|Geometric LS Mean Ratio|1.07|||||TWO_SIDED|90.0|0.82|1.4||||||||1.40|0.82|
71031239|NCT02653664|141570688|SUPERIORITY|||||||0.39||||||Statistical significance was set at p=.05|ANOVA|||Based on our prior work comparing similar interventions, assuming decreases in average pain intensity of 0.3 points (on a 0-10 scale) for ED, between 0.8 to 1.4 points for HYP, and between 0.6 to 1 for MM, with standard deviations (SD) ranging from 0.15 to 1, significance level of 0.05, and using ANOVA as the statistical method, we calculated that 80 participants per arm at immediate post-treatment would provide at least 80% power to detect between-groups differences as specified.||||.39
71031240|NCT02653664|141570689|SUPERIORITY|||||||0.05||||||Statistical significance was set at p=.05.|ANOVA|||||||.05
71031241|NCT02653664|141570690|SUPERIORITY||||||<|0.001||||||Statistical significance was set at p= .05|ANOVA|||||||<.001
71031242|NCT02058498|141570729|SUPERIORITY_OR_OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
71031243|NCT01643707|141570732|SUPERIORITY|A chi-square test was performed to determine a difference between Phase 1 and Phase 2.|||||<|1e-05|||||||Chi-squared|||||||<0.00001
71031244|NCT01643707|141570733|EQUIVALENCE|Chi-Square test used to show any difference between Phase 1 and Phase 2|||||<|0.0001|||||||Chi-squared|||||||<0.0001
71031245|NCT01643707|141570734|EQUIVALENCE|Chi-Square test used to show any difference between Phase 1 and Phase 2|||||<|0.0001||||||This endpoint was covered in primary objective 2, so this analysis is the same as previously reported.|Chi-squared||||See Primary Objectives for additional details.|||<0.0001
71031246|NCT01391793|141570739|SUPERIORITY|||||||0.16|||||||Regression, Logistic|The p-value is adjusted for the stratification variable, duration of fever, and for age at baseline (\<24 months, \>=24 months).||Null hypothesis: There is no difference between the two treatment arms regarding the proportion of children with renal scarring at the outcome DMSA renal scan.||||0.16
71031247|NCT01391793|141570740|SUPERIORITY|||||||0.25|||||||Test of equality - 2 Poisson parameters|The method used is a conditional test.||Null hypothesis: There is no difference between the two treatment arms regarding the proportion of children with severe renal scarring at the outcome DMSA renal scan.||||0.25
71031248|NCT01391793|141570741|SUPERIORITY|||||||0.07|||||||Generalized estimating equations|The p-value is adjusted for the stratification variable, duration of fever, and for age at baseline (\<24 months, \>=24 months).||Null hypothesis: There is no difference between the two treatment arms regarding the mean proportion of children with renal scarring at the outcome DMSA scan taken across the 3 radiologists.||||0.07
71031249|NCT02087904|141570747|SUPERIORITY||LS Mean Difference|-0.3||||0.834|TWO_SIDED|95.0|-3.13|2.53||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and Kellgren-Lawrence (K-L) grade as the main factors and baseline as a covariate.|ANCOVA|||||2.53|-3.13|0.834
71031250|NCT02087904|141570747|SUPERIORITY||LS Mean Difference|-2.9||||0.05|TWO_SIDED|95.0|-5.73|0.01||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.01|-5.73|0.05
71031251|NCT02087904|141570747|SUPERIORITY||LS Mean Difference|-1.2||||0.415|TWO_SIDED|95.0|-4.0|1.66||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||1.66|-4.00|0.415
71031252|NCT02087904|141570748|SUPERIORITY||LS Mean Difference|0.06||||0.145|TWO_SIDED|95.0|-0.021|0.141||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.141|-0.021|0.145
71031253|NCT02087904|141570748|SUPERIORITY||LS Mean Difference|-0.03||||0.52|TWO_SIDED|95.0|-0.11|0.056||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.056|-0.11|0.52
70909649|NCT04707391|141307392|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers between MenABCWY group and MenACWY group was above -10% for serogroup A.|Difference in percentage of participants|0.2|||||TWO_SIDED|0.95|-4.38|3.5||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups A at 1 month after the second MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||3.50|-4.38|
70909650|NCT04707391|141307392|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers between MenABCWY group and MenACWY group was above -10% for serogroup C.|Difference in percentage of participants|0.5|||||TWO_SIDED|0.95|-4.14|3.98||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups C at 1 month after the second MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||3.98|-4.14|
70909651|NCT04707391|141307392|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers between MenABCWY group and MenACWY group was above -10% for each serogroup W.|Difference in percentage of participants|1.6|||||TWO_SIDED|0.95|-2.73|4.89||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups W at 1 month after the second MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||4.89|-2.73|
70909652|NCT04707391|141307392|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers between MenABCWY group and MenACWY group was above -10% for each serogroup Y.|Difference in percentage of participants|0.6|||||TWO_SIDED|0.95|-3.93|3.91||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups Y at 1 month after the second MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||3.91|-3.93|
70909653|NCT04707391|141307393|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in the 4-fold rise in hSBA titers (p\_MenABCWY- p\_MenACWY) is above -10% for serogroup A.|Difference in percentage of participants|-2.5|||||TWO_SIDED|0.95|-5.59|0.47||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups A at 1 month after the first MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||0.47|-5.59|
70909654|NCT04707391|141307393|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers (p\_MenABCWY- p\_MenACWY) is above -10% for serogroup C.|Difference in percentage of participants|0.1|||||TWO_SIDED|0.95|-2.76|2.94||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups C at 1 month after the first MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||2.94|-2.76|
70909655|NCT04707391|141307393|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers (p\_MenABCWY- p\_MenACWY) is above -10% for serogroup W.|Difference in percentage of participants|0.4|||||TWO_SIDED|0.95|-2.41|3.25||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroupsW at 1 month after the first MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||3.25|-2.41|
70909656|NCT04707391|141307393|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers (p\_MenABCWY- p\_MenACWY) is above -10% for serogroup Y.|Difference in percentage of participants|-0.8|||||TWO_SIDED|0.95|-3.62|2.09||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups Y at 1 month after the first MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||2.09|-3.62|
70909657|NCT01438229|141307421|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
70909658|NCT01163149|141307450|SUPERIORITY|If p-values were less than 0.05 and the Hodges-Lehman-Sen estimate favored asfotase alfa (eg, it had a negative sign indicating the between-group differences in change from Baseline favored treated patients), then superiority over control was claimed.|Hodges-Lehman-Sen|-302.05||||0.0285|TWO_SIDED|95.0|-626.4|-59.2||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||PLP Change from Baseline to Week 24||-59.20|-626.40|0.0285
70909659|NCT01163149|141307451|SUPERIORITY|If p-values were less than 0.05 and the Hodges-Lehman-Sen estimate favored asfotase alfa (eg, it had a negative sign indicating the between-group differences in change from Baseline favored treated patients), then superiority over control was claimed.|Hodges-Lehman-Sen|-1.825||||0.0715|TWO_SIDED|95.0|-3.21|0.23||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum||Estimate and exact confidence interval are from Hodges-Lehmann-Sen method for location shift in distribution between the treatment group and the control group.|PPi Change from Baseline to Week 24||0.230|-3.210|0.0715
70909660|NCT01163149|141307453|SUPERIORITY||Hodges-Lehmann-Sen|-0.91||||0.3301|TWO_SIDED|95.0|-3.32|1.78||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||Hip Total BMC Change from Baseline to Week 24||1.780|-3.320|0.3301
70909661|NCT01163149|141307453|SUPERIORITY||Hodges-Lehmann-Sen|1.33||||0.3827|TWO_SIDED|95.0|-1.36|3.12||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||Lumbar Spine BMC Change from Baseline to Week 24||3.120|-1.360|0.3827
70909662|NCT01163149|141307453|SUPERIORITY||Hodges-Lehmann-Sen|-77.1||||0.0485|TWO_SIDED|95.0|-917.44|-1.74||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||Whole Body BMC Change from Baseline to Week 24||-1.740|-917.440|0.0485
70909663|NCT01163149|141307454|SUPERIORITY||Hodges-Lehmann-Sen|-0.0125||||0.7357|TWO_SIDED|95.0|-0.04|0.039||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||Hip Total Change from Baseline to Week 24||0.0390|-0.0400|0.7357
70909664|NCT01163149|141307454|SUPERIORITY||Hodges-Lehmann-Sen|0.0255||||0.2439|TWO_SIDED|95.0|-0.009|0.041||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||Lumbar Spine BMD Change from Baseline to Week 24||0.0410|-0.0090|0.2439
70909665|NCT01163149|141307454|SUPERIORITY||Hodges-Lehmann-Sen|-0.0315||||0.1222|TWO_SIDED|95.0|-0.059|0.012||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||Whole Body BMD Change from Baseline to Week 24||0.0120|-0.0590|0.1222
70909666|NCT01163149|141307455|SUPERIORITY||Hodges-Lehmann-Sen|44.0||||0.1303|TWO_SIDED|95.0|-73.0|114.0||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum||Estimate and exact confidence interval are from Hodges-Lehmann-Sen method for location shift in distribution between the treatment group and the control group|Week 24 Change from Baseline||114.0|-73.0|0.1303
70909667|NCT01923428|141307498|SUPERIORITY||Risk Difference (RD)|27.0|||<|0.001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
70909668|NCT02550873|141307499|SUPERIORITY||Mean Difference (Net)|2.3|STANDARD_ERROR_OF_MEAN|0.72||0.0014|TWO_SIDED|90.0|1.1|3.5||a priori threshold for statistical significance = 0.10|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||"The sample size calculation was based on the following assumptions:~Normal distribution Homogeneity of variance the same in both arms, and for both types of patients Randomization ratio PRM-151:placebo = 2:1 Expected value for patients on pirfenidone or nintedanib = -1.5 Expected value for patients on no other treatment = -3 Expected value for patients on PRM-151 ≥ 0.75 Standard deviation = 5 75% of patients on a stable dose of pirfenidone or nintedanib α=0.10 two-sided Power = 80%"||3.5|1.1|0.0014
70909669|NCT02550873|141307500|SUPERIORITY||Mean Difference (Net)|31.3|STANDARD_ERROR_OF_MEAN|8.42||0.0002|TWO_SIDED|90.0|17.4|45.1||This study was not powered to test hypothesis beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction.||||45.1|17.4|0.0002
70909670|NCT02550873|141307501|SUPERIORITY||Mean Difference (Net)|93.5|STANDARD_ERROR_OF_MEAN|72.98||0.2032|TWO_SIDED|90.0|-27.7|214.7||This study was not powered to test hypothesis beyond the primary endpoint.|Mixed Models Analysis|Random intercept and slope; dependent variable=raw values; explanatory variables=stratum, treatment, time and treatment by time interaction.||||214.7|-27.7|0.2032
70909671|NCT02550873|141307502|SUPERIORITY||Mean Difference (Net)|31.9|STANDARD_ERROR_OF_MEAN|46.33||0.4927|TWO_SIDED|90.0|-45.0|108.8||This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||108.8|-45.0|0.4927
70909672|NCT02550873|141307503|SUPERIORITY||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|1.96||0.5835|TWO_SIDED|90.0|-2.2|4.3||This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||4.3|-2.2|0.5835
70909673|NCT02550873|141307504|SUPERIORITY||Mean Difference (Net)|43.6|STANDARD_ERROR_OF_MEAN|102.28||0.6707|TWO_SIDED|90.0|-126.3|213.5||This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||213.5|-126.3|0.6707
70909674|NCT02550873|141307505|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|1.91||0.52|TWO_SIDED|90.0|-4.4|1.9||This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||1.9|-4.4|0.52
70909675|NCT02550873|141307506|OTHER|Correlation analysis||||||0.0001||||||This study was not powered to test hypotheses beyond the primary endpoint.|Pearson's correlation|||||||0.0001
70909676|NCT02550873|141307506|OTHER|Correlation analysis||||||0.0069|||||||Pearson's correlation|||This study was not powered to test hypotheses beyond the primary endpoint.||||0.0069
70909677|NCT02550873|141307507|SUPERIORITY|||||||0.4179||||||P-Value for decline in % Predicted FVC ≥ 5%. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.4179
70909678|NCT02550873|141307507|SUPERIORITY|||||||0.2184||||||P-Value for decline in % predicted FVC ≥ 10%. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.2184
70909679|NCT02550873|141307508|SUPERIORITY|||||||0.7773||||||P-Value for decline in FVC ≥ 100 mL. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.7773
70909680|NCT02550873|141307508|SUPERIORITY|||||||0.5976||||||P-Value for decline in FVC ≥ 200 mL. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.5976
70909681|NCT02550873|141307509|SUPERIORITY|||||||0.29||||||P-Value for increase in % predicted FVC ≥ 5%. P-Value for an increase in % predicted FVC ≥ 10% not reported. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.29
70909682|NCT02550873|141307510|SUPERIORITY|||||||0.0508||||||P-Value for increase in FVC ≥ 100 mL. P-Value for increase in FVC ≥ 200 mL not reported. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.0508
70909683|NCT02550873|141307511|SUPERIORITY|||||||0.6308||||||This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.6308
70909684|NCT02550873|141307512|SUPERIORITY|||||||0.1846||||||This study was not powered to test hypothesis beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.1846
70909685|NCT02550873|141307513|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|1.31||0.7424|TWO_SIDED|90.0|-2.6|1.7||This study was not powered to test hypothesis beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction.||||1.7|-2.6|0.7424
70909686|NCT02550873|141307523|SUPERIORITY||Mean Difference (Net)|114.6|STANDARD_DEVIATION|56.1||0.0416|TWO_SIDED|90.0|22.2|207.1||This study was not powered to test hypothesis beyond the primary endpoint.|Mixed Models Analysis|Random intercept and slope; dependent variable=raw values; explanatory variables=stratum, treatment, time and treatment by time interaction.||||207.1|22.2|0.0416
70909687|NCT04320615|141307530|OTHER||Median Difference (Final Values)|-1.0||||0.36|TWO_SIDED|95.0|-2.5|0.0|||Van Elteren Test|||||0.0|-2.5|0.3600
70909688|NCT04320615|141307531|OTHER||Hazard Ratio (HR)|1.448||||0.0443|TWO_SIDED|95.0|1.01|2.08|||Log Rank|||||2.08|1.01|0.0443
70909689|NCT04320615|141307532|OTHER||Hazard Ratio (HR)|1.263||||0.082|TWO_SIDED|95.0|0.97|1.64|||Log Rank|||||1.64|0.97|0.0820
70909690|NCT04320615|141307533|OTHER||Hazard Ratio (HR)|1.35||||0.037|TWO_SIDED|95.0|1.02|1.79|||Log Rank|||||1.79|1.02|0.0370
70909691|NCT04320615|141307534|OTHER||Weighted % difference|-6.2||||0.0996|TWO_SIDED|95.0|-13.8|1.4|||Cochran-Mantel-Haenszel|||||1.4|-13.8|0.0996
70909692|NCT04320615|141307534|OTHER||Weighted % difference|-8.9||||0.1355|TWO_SIDED|95.0|-20.7|3.0|||Cochran-Mantel-Haenszel|||||3.0|-20.7|0.1355
70909693|NCT04320615|141307535|OTHER||Median Difference (Final Values)|5.5||||0.3202|TWO_SIDED|95.0|-2.8|13.0|||Van Elteren test|||||13.0|-2.8|0.3202
70909694|NCT04320615|141307536|OTHER||Weighted % difference|-5.7||||0.1514|TWO_SIDED|95.0|-13.7|2.2|||Cochran-Mantel-Haenszel|||||2.2|-13.7|0.1514
70909695|NCT04320615|141307536|OTHER||Weighted % difference|-14.8||||0.029|TWO_SIDED|95.0|-28.6|-1.0|||Cochran-Mantel-Haenszel|||||-1.0|-28.6|0.0290
70909696|NCT04320615|141307537|OTHER||Median Difference (Final Values)|-5.8||||0.0454|TWO_SIDED|95.0|-15.0|2.9|||Van Elteren test|||||2.9|-15.0|0.0454
70909697|NCT04320615|141307538|OTHER||Median Difference (Final Values)|-1.0||||0.0548|TWO_SIDED|95.0|-2.0|0.5|||Van Elteren test|||||0.5|-2.0|0.0548
70909698|NCT04320615|141307539|OTHER||Hazard Ratio (HR)|0.79||||0.1627|TWO_SIDED|95.0|0.57|1.1|||Log Rank|||||1.10|0.57|0.1627
71031254|NCT02087904|141570748|SUPERIORITY||LS Mean Difference|0.06||||0.159|TWO_SIDED|95.0|-0.023|0.139||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.139|-0.023|0.159
70909699|NCT04320615|141307540|OTHER||Weighted % difference|0.3||||0.941|TWO_SIDED|95.0|-7.6|8.2|||Cochran-Mantel-Haenszel|||||8.2|-7.6|0.9410
70909700|NCT04320615|141307541|OTHER||Hazard Ratio (HR)|1.307||||0.0528|TWO_SIDED|95.0|1.0|1.72|||Log Rank|||||1.72|1.00|0.0528
70909701|NCT04320615|141307542|OTHER||Median Difference (Final Values)|-1.5||||0.0477|TWO_SIDED|95.0|-9.0|0.5|||Van Elteren test|||||0.5|-9.0|0.0477
70909702|NCT01449721|141307543|SUPERIORITY_OR_OTHER|||||||0.064|||||||2-sample z-test|z-test for differences in proportions||Null hypothesis: In patients with moderate severity sepsis, there is no change in the incidence of organ dysfunction within 72 hours associated with the use of an empiric fluid resuscitation algorithm.||||0.064
70909703|NCT03786094|141307566|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.445|TWO_SIDED|96.0|0.85|1.41|||t-test, 2 sided||HR and associated 2-sided 96% CI are estimated by a Cox proportional hazards model stratified for randomization stratification factors including a fixed effect term for treatment arm.|||1.41|0.85|0.4450
70909704|NCT03786094|141307567|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.6158|TWO_SIDED|96.0|0.81|1.41|||t-test, 2 sided||HR and associated 2-sided 96% CI are estimated by a Cox proportional hazards model stratified for randomization stratification factors including a fixed effect term for treatment arm.|||1.41|0.81|0.6158
70909705|NCT03786094|141307568|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.6126|TWO_SIDED|99.9|0.66|1.77|||t-test, 2 sided|||||1.77|0.66|0.6126
70909706|NCT02320721|141307572|NON_INFERIORITY|Non-inferiority of HOE901-U300 vs Lantus was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for the difference between groups was \<0.3%.|LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.056|||TWO_SIDED|95.0|-0.092|0.129||||||Analysis was performed using ANCOVA model including the fixed categorical effects of treatment group, randomization strata, as well as the continuous fixed covariates of baseline value and following multiple imputation procedure for missing data.||0.129|-0.092|
70909707|NCT02320721|141307573|SUPERIORITY_OR_OTHER_LEGACY|A hierarchical testing procedure was used to control type I error and handle multiple endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only if previous endpoint was statistically significant at 0.05 level.|Relative risk|1.01||||0.8415|TWO_SIDED|95.0|0.89|1.153||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was done by Cochran-Mantel-Haenszel method with randomization strata (screening HbA1c \[\<8.0%; ≥8.0%\], previous use of insulin \[naive, pre-treated\], use of sulfonylurea or meglitinides at screening \[yes, no\]), following multiple imputation procedure for missing data.||1.153|0.890|0.8415
70909708|NCT02036515|141307620|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.69|||<|0.001|TWO_SIDED|95.0|-0.87|-0.5|||Constrained longitudinal data analysis|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-0.50|-0.87|<0.001
70909709|NCT02036515|141307620|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.76|||<|0.001|TWO_SIDED|95.0|-0.95|-0.58|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-0.58|-0.95|<0.001
70909710|NCT02036515|141307621|SUPERIORITY_OR_OTHER||Difference in percentage|-5.7|||||TWO_SIDED|95.0|-16.5|5.2||||||||5.2|-16.5|
70909711|NCT02036515|141307621|SUPERIORITY_OR_OTHER||Difference in percentage|-3.3|||||TWO_SIDED|95.0|-14.1|7.6||||||||7.6|-14.1|
70909712|NCT02036515|141307622|SUPERIORITY_OR_OTHER||Difference in percentage|0.6|||||TWO_SIDED|95.0|-4.4|5.6||||||||5.6|-4.4|
70909713|NCT02036515|141307622|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-4.9|4.9||||||||4.9|-4.9|
70909714|NCT02036515|141307623|SUPERIORITY_OR_OTHER||Differenc in least squares means|-25.15|||<|0.001|TWO_SIDED|95.0|-32.76|-17.54|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-17.54|-32.76|<0.001
70909715|NCT02036515|141307623|SUPERIORITY_OR_OTHER||Difference in least squares means|-31.28|||<|0.001|TWO_SIDED|95.0|-38.9|-23.66|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-23.66|-38.90|<0.001
70909716|NCT02036515|141307624|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.03|||<|0.001|TWO_SIDED|95.0|-2.65|-1.4|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-1.40|-2.65|<0.001
70909717|NCT02036515|141307624|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.72|||<|0.001|TWO_SIDED|95.0|-2.35|-1.09|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-1.09|-2.35|<0.001
70909718|NCT02036515|141307625|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.16|||<|0.001|TWO_SIDED|95.0|1.74|5.72|||Regression, Logistic|Logistic regression model fitted with terms for treatment, baseline A1C, baseline eGFR and prior antihyperglycemic medication.||||5.72|1.74|<0.001
70909719|NCT02036515|141307625|SUPERIORITY_OR_OTHER||Difference in least squares means|4.43|||<|0.001|TWO_SIDED|95.0|2.44|8.02|||Regression, Logistic|Logistic regression model fitted with terms for treatment, baseline A1C, baseline eGFR and prior antihyperglycemic medication.||||8.02|2.44|<0.001
70909720|NCT02036515|141307626|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.93||||0.019|TWO_SIDED|95.0|-5.36|-0.49|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-0.49|-5.36|0.019
70909721|NCT02036515|141307626|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.94||||0.002|TWO_SIDED|95.0|-6.39|-1.5|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-1.50|-6.39|0.002
70909722|NCT02036515|141307627|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.76|||||TWO_SIDED|95.0|-0.98|-0.54||||||||-0.54|-0.98|
70909723|NCT02036515|141307627|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.83|||||TWO_SIDED|95.0|-1.05|-0.61||||||||-0.61|-1.05|
70909724|NCT02036515|141307628|SUPERIORITY_OR_OTHER||Difference in least squares means|-28.76|||||TWO_SIDED|95.0|-36.44|-21.09||||||||-21.09|-36.44|
70909725|NCT02036515|141307628|SUPERIORITY_OR_OTHER||Difference in least squares means|-29.58|||||TWO_SIDED|95.0|-37.3|-21.85||||||||-21.85|-37.30|
70909726|NCT02036515|141307629|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.51|||||TWO_SIDED|95.0|-3.43|-1.59||||||||-1.59|-3.43|
70909727|NCT02036515|141307629|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.88|||||TWO_SIDED|95.0|-2.81|-0.95||||||||-0.95|-2.81|
70909728|NCT02036515|141307630|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.63|||||TWO_SIDED|95.0|1.98|6.64||||||||6.64|1.98|
71031255|NCT02087904|141570749|SUPERIORITY||LS Mean Difference|0.22||||0.897|TWO_SIDED|95.0|-3.193|3.642||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||3.642|-3.193|0.897
70909729|NCT02036515|141307630|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.02|||||TWO_SIDED|95.0|2.22|7.28||||||||7.28|2.22|
70909730|NCT02036515|141307631|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.99|||||TWO_SIDED|95.0|-7.82|-2.15||||||||-2.15|-7.82|
70909731|NCT02036515|141307631|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.92|||||TWO_SIDED|95.0|-7.76|-2.07||||||||-2.07|-7.76|
70909732|NCT02036515|141307632|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.24|||||TWO_SIDED|95.0|-2.97|0.48||||||||0.48|-2.97|
70909733|NCT02036515|141307632|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.38|||||TWO_SIDED|95.0|-3.11|0.36||||||||0.36|-3.11|
70909734|NCT02036515|141307633|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.99|||||TWO_SIDED|95.0|-2.82|0.84||||||||0.84|-2.82|
70909735|NCT02036515|141307633|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.85|||||TWO_SIDED|95.0|-2.69|0.99||||||||0.99|-2.69|
70909736|NCT02036515|141307634|SUPERIORITY_OR_OTHER||Difference in percent|-15.1|||||TWO_SIDED|95.0|-21.9|-9.4||||||||-9.4|-21.9|
70909737|NCT02036515|141307634|SUPERIORITY_OR_OTHER||Difference in percent|-14.4|||||TWO_SIDED|95.0|-21.3|-8.5||||||||-8.5|-21.3|
70909738|NCT02036515|141307635|SUPERIORITY_OR_OTHER||Difference in percentage|-29.0|||||TWO_SIDED|95.0|-38.3|-19.4||||||||-19.4|-38.3|
70909739|NCT02036515|141307635|SUPERIORITY_OR_OTHER||Difference in percentage|-28.1|||||TWO_SIDED|95.0|-37.5|-18.4||||||||-18.4|-37.5|
70909740|NCT02036515|141307639|SUPERIORITY_OR_OTHER||Difference in least squares means|12.75|||||TWO_SIDED|95.0|6.83|18.68||||||||18.68|6.83|
70909741|NCT02036515|141307639|SUPERIORITY_OR_OTHER||Difference in least squares means|11.91|||||TWO_SIDED|95.0|5.94|17.88||||||||17.88|5.94|
70909742|NCT02036515|141307640|SUPERIORITY_OR_OTHER||Difference in least squares means|12.78|||||TWO_SIDED|95.0|6.54|19.03||||||||19.03|6.54|
70909743|NCT02036515|141307640|SUPERIORITY_OR_OTHER||Difference in least squares means|12.86|||||TWO_SIDED|95.0|6.54|19.18||||||||19.18|6.54|
70909744|NCT02036515|141307642|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.01|||||TWO_SIDED|95.0|-0.04|0.02||||||||0.02|-0.04|
70909745|NCT02036515|141307642|SUPERIORITY_OR_OTHER||Difference in least squares means|0.01|||||TWO_SIDED|95.0|-0.02|0.04||||||||0.04|-0.02|
70909746|NCT02036515|141307643|SUPERIORITY_OR_OTHER||Difference in least squares means|0.0|||||TWO_SIDED|95.0|-0.04|0.04||||||||0.04|-0.04|
70909747|NCT02036515|141307643|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.02|||||TWO_SIDED|95.0|-0.07|0.02||||||||0.02|-0.07|
70909748|NCT03317379|141307692|SUPERIORITY||estimate of fixed effects|0.03|STANDARD_ERROR_OF_MEAN|0.1||0.8|TWO_SIDED|95.0|-0.17|0.22||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||0.22|-0.17|.80
70909749|NCT03317379|141307692|SUPERIORITY||estimate of fixed effects|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.32|TWO_SIDED|95.0|-0.1|0.3||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||0.30|-0.10|.32
70909750|NCT03317379|141307693|SUPERIORITY||estimate of fixed effects|0.14|STANDARD_ERROR_OF_MEAN|0.05||0.01|TWO_SIDED|95.0|0.03|0.24||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||0.24|0.03|0.01
70909751|NCT03317379|141307693|SUPERIORITY||estimate of fixed effects|0.08|STANDARD_ERROR_OF_MEAN|0.07||0.28|TWO_SIDED|95.0|-0.07|0.23||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||0.23|-.07|0.28
70909752|NCT03317379|141307694|SUPERIORITY||estimate of fixed effects|0.61|STANDARD_ERROR_OF_MEAN|0.28||0.03|TWO_SIDED|95.0|0.06|1.16||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||1.16|0.06|0.03
70909753|NCT03317379|141307694|SUPERIORITY||estimate of fixed effects|0.68|STANDARD_ERROR_OF_MEAN|0.29||0.02|TWO_SIDED|95.0|0.09|1.27|||Mixed Models Analysis|||||1.27|0.09|0.02
70909754|NCT03317379|141307695|SUPERIORITY||estimate of fixed effects|0.2|STANDARD_ERROR_OF_MEAN|0.11||0.08|TWO_SIDED|95.0|-0.02|0.42||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||0.42|-0.02|0.08
70909755|NCT03317379|141307695|SUPERIORITY||estimate of fixed effects|0.18|STANDARD_ERROR_OF_MEAN|0.12||0.12|TWO_SIDED|95.0|-0.04|0.41||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||0.41|-0.04|0.12
70909756|NCT03317379|141307696|SUPERIORITY||estimate of fixed effects|0.03|STANDARD_ERROR_OF_MEAN|0.22||0.18|TWO_SIDED|95.0|-0.14|0.74||the a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||0.74|-0.14|0.18
70909757|NCT03317379|141307696|SUPERIORITY||estimate of fixed effects|0.16|STANDARD_ERROR_OF_MEAN|0.23||0.5|TWO_SIDED|95.0|-0.3|0.62||the a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||0.62|-0.30|0.50
70909758|NCT04445155|141307697|SUPERIORITY|||||||0.125|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||0.125
70909759|NCT04445155|141307699|SUPERIORITY|||||||0.011|||||||Paired t-test|||"Null Hypothesis: The means of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The means of the scores are different at baseline and immediately post-intervention."||||0.011
70909760|NCT04445155|141307700|SUPERIORITY|||||||0.002|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||0.002
70909761|NCT04445155|141307700|SUPERIORITY|||||||0.008|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||0.008
70909762|NCT04445155|141307701|SUPERIORITY||||||<|0.001|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||<0.001
70909763|NCT04445155|141307701|SUPERIORITY|||||||0.002|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||0.002
70909764|NCT04445155|141307702|SUPERIORITY||||||<|0.001|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||<0.001
70909765|NCT04445155|141307702|SUPERIORITY|||||||0.125|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||0.125
70909766|NCT00550173|141307706|SUPERIORITY_OR_OTHER|||||||0.003||||||If global test across 3 arms is significant at a 2-sided 0.2 level, then conduct 2-sided pairwise tests between combination and each single agent under the global model. Significance is claimed only if both the global and pairwise tests p\<0.05.|Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||Overall; Global null hypothesis was rejected at 2-sided 0.2 significance level.||||0.003
70909767|NCT00550173|141307706|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.002|TWO_SIDED|95.0|0.4|0.81||If global test across 3 arms is significant at a 2-sided 0.2 level, then conduct 2-sided pairwise tests between combination and each single agent under the global model. Significance is claimed only if both the global and pairwise tests p\<0.05.|Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||Primary Analysis; Global null hypothesis was rejected at 2-sided 0.2 significance level.||0.81|0.40|0.002
70909768|NCT00550173|141307706|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.005|TWO_SIDED|95.0|0.39|0.85||If global test across 3 arms is significant at a 2-sided 0.2 level, then conduct 2-sided pairwise tests between combination and each single agent under the global model. Significance is claimed only if both the global and pairwise tests p\<0.05.|Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||Primary Analysis; Global null hypothesis was rejected at 2-sided 0.2 significance level.||0.85|0.39|0.005
71031256|NCT02087904|141570749|SUPERIORITY||LS Mean Difference|-1.07||||0.542|TWO_SIDED|95.0|-4.515|2.377||P-value for test of difference between ABT-981 100 dose group and Placebo at each post-baseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||2.377|-4.515|0.542
70909769|NCT00550173|141307706|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.99||||0.959|TWO_SIDED|95.0|0.7|1.4||If global test across 3 arms is significant at a 2-sided 0.2 level, then conduct 2-sided pairwise tests between combination and each single agent under the global model. Significance is claimed only if both the global and pairwise tests p\<0.05.|Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||Secondary Analysis; Global null hypothesis was rejected at 2-sided 0.2 significance level.||1.40|0.70|0.959
70909770|NCT00550173|141307707|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||||<0.001
70909771|NCT00550173|141307707|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.09||||0.031|TWO_SIDED|95.0|1.07|4.09|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||4.09|1.07|0.031
70909772|NCT00550173|141307707|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.68|||<|0.001|TWO_SIDED|95.0|3.19|18.48|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||18.48|3.19|<0.001
70909773|NCT00550173|141307707|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.27||||0.004|TWO_SIDED|95.0|0.11|0.66|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||0.66|0.11|0.004
70909774|NCT00550173|141307708|SUPERIORITY_OR_OTHER|||||||0.194|||||||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||||0.194
70909775|NCT00550173|141307708|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.747|TWO_SIDED|95.0|0.69|1.67|||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||1.67|0.69|0.747
70909776|NCT00550173|141307708|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.168|TWO_SIDED|95.0|0.49|1.13|||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||1.13|0.49|0.168
70909777|NCT00550173|141307708|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.44||||0.094|TWO_SIDED|95.0|0.94|2.21|||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||2.21|0.94|0.094
70909778|NCT00550173|141307710|SUPERIORITY_OR_OTHER|||||||0.306|||||||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||||0.306
70909779|NCT00550173|141307710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.127|TWO_SIDED|95.0|0.87|3.18|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||3.18|0.87|0.127
70909780|NCT00550173|141307710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.318|TWO_SIDED|95.0|0.72|2.71|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||2.71|0.72|0.318
70909781|NCT00550173|141307710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.599|TWO_SIDED|95.0|0.63|2.22|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||2.22|0.63|0.599
70909782|NCT00550173|141307711|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||||0.013
70909783|NCT00550173|141307711|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59||||0.007|TWO_SIDED|95.0|0.41|0.87||Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.|Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||0.87|0.41|0.007
70909784|NCT00550173|141307711|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.7|TWO_SIDED|95.0|0.62|1.38|||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||1.38|0.62|0.700
70909785|NCT00550173|141307711|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.023|TWO_SIDED|95.0|0.44|0.94|||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||0.94|0.44|0.023
70909786|NCT00550173|141307712|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Regression, Cox|||||||0.040
70909787|NCT00550173|141307712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.241|TWO_SIDED|95.0|0.27|1.38|||Regression, Cox|||||1.38|0.27|0.241
70909788|NCT00550173|141307712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.32||||0.011|TWO_SIDED|95.0|0.14|0.78|||Regression, Cox|||||0.78|0.14|0.011
70909789|NCT00550173|141307712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.9||||0.128|TWO_SIDED|95.0|0.83|4.36|||Regression, Cox|||||4.36|0.83|0.128
70909790|NCT00802841|141307751|SUPERIORITY_OR_OTHER|||||||0.3106|TWO_SIDED||||||Fisher Exact|||||||0.3106
70909791|NCT00377741|141307777|SUPERIORITY_OR_OTHER||Mean exposure ratio for AUC(0-tau)|1.24|||||TWO_SIDED|90.0|0.98|1.55||||||||1.55|0.98|
70909792|NCT00377741|141307778|SUPERIORITY_OR_OTHER||Mean exposure ratio for Cmax|1.12|||||TWO_SIDED|90.0|0.88|1.42||||||||1.42|0.88|
70909793|NCT03531905|141307806|SUPERIORITY||Difference of Least Squares (LS) means|-39.6|STANDARD_ERROR_OF_MEAN|3.14|<|0.001|TWO_SIDED|95.0|-45.8|-33.4|||ANCOVA|||||-33.4|-45.8|<0.001
70909794|NCT03531905|141307806|SUPERIORITY||Difference of LS means|-19.5|STANDARD_ERROR_OF_MEAN|3.11|<|0.001|TWO_SIDED|95.0|-25.7|-13.4|||ANCOVA|||||-13.4|-25.7|<0.001
70909795|NCT03531905|141307806|SUPERIORITY||Difference of LS means|-20.1|STANDARD_ERROR_OF_MEAN|3.08|<|0.001|TWO_SIDED|95.0|-26.2|-14.0|||ANCOVA|||||-14.0|-26.2|<0.001
70909796|NCT03531905|141307807|SUPERIORITY||Difference of LS means|-20.1|STANDARD_ERROR_OF_MEAN|3.08|<|0.001|TWO_SIDED|95.0|-26.2|-14.0|||ANCOVA|||||-14.0|-26.2|<0.001
70909797|NCT03531905|141307808|SUPERIORITY||Location shift|-36.7|STANDARD_ERROR_OF_MEAN|9.77|<|0.001|TWO_SIDED|95.0|-55.97|-17.67|||Wilcoxon rank sum test|||||-17.67|-55.97|<0.001
70909798|NCT03531905|141307808|SUPERIORITY||Location shift|-29.2|STANDARD_ERROR_OF_MEAN|10.03||0.005|TWO_SIDED|95.0|-48.92|-9.62|||Wilcoxon rank sum test|||||-9.62|-48.92|0.005
70909799|NCT03531905|141307808|SUPERIORITY||Location shift|-7.5|STANDARD_ERROR_OF_MEAN|11.29||0.48|TWO_SIDED|95.0|-30.51|13.76|||Wilcoxon rank sum test|||||13.76|-30.51|0.480
70909800|NCT03531905|141307809|SUPERIORITY||Difference of LS means|-33.1|STANDARD_ERROR_OF_MEAN|2.81|<|0.001|TWO_SIDED|95.0|-38.6|-27.5|||ANCOVA|||||-27.5|-38.6|<0.001
70909801|NCT03531905|141307809|SUPERIORITY||Difference of LS means|-15.3|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-20.8|-9.7|||ANCOVA|||||-9.7|-20.8|<0.001
70909802|NCT03531905|141307809|SUPERIORITY||Difference of LS means|-17.8|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-23.3|-12.4|||ANCOVA|||||-12.4|-23.3|<0.001
70909803|NCT03531905|141307810|SUPERIORITY||Difference of LS means|-27.2|STANDARD_ERROR_OF_MEAN|2.25|<|0.001|TWO_SIDED|95.0|-31.7|-22.8|||ANCOVA|||||-22.8|-31.7|<0.001
70909804|NCT03531905|141307810|SUPERIORITY||Difference of LS means|-13.4|STANDARD_ERROR_OF_MEAN|2.24|<|0.001|TWO_SIDED|95.0|-17.8|-9.0|||ANCOVA|||||-9.0|-17.8|<0.001
70909805|NCT03531905|141307810|SUPERIORITY||Difference of LS means|-13.9|STANDARD_ERROR_OF_MEAN|2.21|<|0.001|TWO_SIDED|95.0|-18.2|-9.5|||ANCOVA|||||-9.5|-18.2|<0.001
70909806|NCT03531905|141307811|SUPERIORITY||Difference of LS means|-27.2|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|-32.6|-21.8|||ANCOVA|||||-21.8|-32.6|<0.001
70909807|NCT03531905|141307811|SUPERIORITY||Difference of LS means|-12.8|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED|95.0|-18.1|-7.4|||ANCOVA|||||-7.4|-18.1|<0.001
70909808|NCT03531905|141307811|SUPERIORITY||Difference of LS means|-14.4|STANDARD_ERROR_OF_MEAN|2.68|<|0.001|TWO_SIDED|95.0|-19.7|-9.1|||ANCOVA|||||-9.1|-19.7|<0.001
70909809|NCT03531905|141307812|SUPERIORITY||Location shift|-3.9|STANDARD_ERROR_OF_MEAN|5.44||0.457|TWO_SIDED|95.0|-14.55|6.79|||Wilcoxon rank sum test|||||6.79|-14.55|0.457
70909810|NCT03531905|141307812|SUPERIORITY||Difference of LS means|4.7|STANDARD_ERROR_OF_MEAN|5.25||0.351|TWO_SIDED|95.0|-4.93|15.63|||ANCOVA|||||15.63|-4.93|0.351
70909811|NCT03531905|141307812|SUPERIORITY||Difference of LS means|-9.2|STANDARD_ERROR_OF_MEAN|4.75||0.068|TWO_SIDED|95.0|-17.92|0.68|||ANCOVA|||||0.68|-17.92|0.068
70909812|NCT03531905|141307813|SUPERIORITY||Difference of LS means|-5.9|STANDARD_ERROR_OF_MEAN|2.14||0.007|TWO_SIDED|95.0|-10.1|-1.7|||ANCOVA|||||-1.7|-10.1|0.007
70909813|NCT03531905|141307813|SUPERIORITY||Difference of LS means|-7.3|STANDARD_ERROR_OF_MEAN|2.12|<|0.001|TWO_SIDED|95.0|-11.5|-3.1|||ANCOVA|||||-3.1|-11.5|<0.001
70909814|NCT03531905|141307813|SUPERIORITY||Difference of LS means|1.4|STANDARD_ERROR_OF_MEAN|2.11||0.517|TWO_SIDED|95.0|-2.8|5.5|||ANCOVA|||||5.5|-2.8|0.517
70909815|NCT03531905|141307814|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
70909816|NCT03531905|141307814|SUPERIORITY|||||||0.118|||||||Fisher Exact|||||||0.118
70909817|NCT03531905|141307814|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
70909818|NCT03531905|141307815|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
70909819|NCT03531905|141307815|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
70909820|NCT03531905|141307817|SUPERIORITY||Difference of LS means|-0.3|STANDARD_ERROR_OF_MEAN|1.83||0.877|TWO_SIDED|95.0|-3.9|3.3|||ANCOVA|||||3.3|-3.9|0.877
70909821|NCT03531905|141307817|SUPERIORITY||Difference of LS means|0.8|STANDARD_ERROR_OF_MEAN|1.83||0.669|TWO_SIDED|95.0|-2.8|4.4|||ANCOVA|||||4.4|-2.8|0.669
70909822|NCT03531905|141307817|SUPERIORITY||Difference of LS means|-1.1|STANDARD_ERROR_OF_MEAN|1.81||0.556|TWO_SIDED|95.0|-4.6|2.5|||ANCOVA|||||2.5|-4.6|0.556
70909823|NCT03531905|141307818|SUPERIORITY||Difference of LS means|2.5|STANDARD_ERROR_OF_MEAN|4.64||0.589|TWO_SIDED|95.0|-6.7|11.7|||ANCOVA|||||11.7|-6.7|0.589
70909824|NCT03531905|141307818|SUPERIORITY||Difference of LS means|0.6|STANDARD_ERROR_OF_MEAN|4.64||0.904|TWO_SIDED|95.0|-8.6|9.7|||ANCOVA|||||9.7|-8.6|0.904
70909825|NCT03531905|141307818|SUPERIORITY||Difference of LS means|2.0|STANDARD_ERROR_OF_MEAN|4.66||0.676|TWO_SIDED|95.0|-7.3|11.2|||ANCOVA|||||11.2|-7.3|0.676
70909826|NCT03531905|141307820|SUPERIORITY||Difference of LS means|-15.8|STANDARD_ERROR_OF_MEAN|13.95||0.258|TWO_SIDED|95.0|-43.4|11.7|||ANCOVA|||||11.7|-43.4|0.258
70909827|NCT03531905|141307820|SUPERIORITY||Difference of LS means|0.5|STANDARD_ERROR_OF_MEAN|13.79||0.972|TWO_SIDED|95.0|-26.8|27.7|||ANCOVA|||||27.7|-26.8|0.972
70909828|NCT03531905|141307820|SUPERIORITY||Difference of LS means|-16.3|STANDARD_ERROR_OF_MEAN|13.68||0.235|TWO_SIDED|95.0|-43.3|10.7|||ANCOVA|||||10.7|-43.3|0.235
71031257|NCT02087904|141570749|SUPERIORITY||LS Mean Difference|-1.52||||0.385|TWO_SIDED|95.0|-4.95|1.916||P-value for test of difference between ABT-981 200 dose group and Placebo at each post-baseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||1.916|-4.95|0.385
71031258|NCT02087904|141570750|SUPERIORITY||LS Mean Difference|-0.08||||0.384|TWO_SIDED|95.0|-0.249|0.096||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.096|-0.249|0.384
70909829|NCT01155726|141307822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.2|1.4||||||Unmasked minus masked||1.4|-2.2|
70909830|NCT01155726|141307822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-1.5|2.5||||||Unmasked minus masked||2.5|-1.5|
70909831|NCT01155726|141307822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|-0.1|2.2||||||Unmasked minus masked||2.2|-0.1|
70909832|NCT01155726|141307822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0|0.2|3.5||||||Unmasked minus masked||3.5|0.2|
70909833|NCT01155726|141307822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-3.3|1.2||||||Partial masked minus masked||1.2|-3.3|
70909834|NCT01155726|141307822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-1.9|1.1||||||Partial masked minus masked||1.1|-1.9|
70909835|NCT01155726|141307822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-2.9|2.7||||||Partial masked minus masked||2.7|-2.9|
70909836|NCT01155726|141307822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-1.1|1.9||||||Partial masked minus masked||1.9|-1.1|
70909837|NCT02724020|141307829|SUPERIORITY||Hazard Ratio (HR)|1.33|||=|0.388|TWO_SIDED|95.0|0.75|2.36|||Stratified Log-rank Test||HR obtained by stratified Cox proportion hazard model adjusted for prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category. A hazard ratio \< 1 indicated an advantage compared to Everolimus.|||2.36|0.75|=0.388
70909838|NCT02724020|141307829|SUPERIORITY||Hazard Ratio (HR)|1.37||||0.667|TWO_SIDED|95.0|0.75|2.52|||Stratified Log-rank Test||HR obtained by stratified Cox proportion hazard model adjusted for prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category. A hazard ratio \< 1 indicated an advantage compared to Everolimus.|||2.52|0.75|0.667
70909839|NCT02724020|141307831|SUPERIORITY||Hazard Ratio (HR)|1.76||||0.212|TWO_SIDED|95.0|0.89|3.49|||Stratified Log-rank Test||HR obtained by stratified Cox proportion hazard model adjusted for prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category. A hazard ratio \< 1 indicated an advantage compared to Everolimus.|||3.49|0.89|0.212
70909840|NCT02724020|141307831|SUPERIORITY||Hazard Ratio (HR)|1.51||||0.546|TWO_SIDED|95.0|0.77|2.98|||Stratified Log-rank Test||HR obtained by stratified Cox proportion hazard model adjusted for prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category. A hazard ratio \< 1 indicated an advantage compared to Everolimus.|||2.98|0.77|0.546
70909841|NCT02724020|141307832|SUPERIORITY||Hazard Ratio (HR)|1.57|||=|0.156|TWO_SIDED|95.0|0.81|3.05|||Log Rank||HR obtained by stratified Cox proportion hazard model adjusted for prior lines of therapy and the International Metastatic Renal Cell Carcinoma Database Consortium risk category. A hazard ratio \< 1 indicates an advantage compared to Everolimus.|||3.05|0.81|=0.156
70909842|NCT02724020|141307832|SUPERIORITY||Hazard Ratio (HR)|1.42||||0.667|TWO_SIDED|95.0|0.72|2.79|||Log Rank||HR obtained by stratified Cox proportion hazard model adjusted for prior lines of therapy and the International Metastatic Renal Cell Carcinoma Database Consortium risk category. A hazard ratio \< 1 indicates an advantage compared to Everolimus.|||2.79|0.72|0.667
70909843|NCT02724020|141307833|SUPERIORITY||Odds Ratio (OR)|0.41|||||TWO_SIDED|95.0|0.08|2.22|||||Odds ratio and 95% CI were obtained using a stratified CMH model with prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category.|As prespecified in the protocol, the statistical analysis was performed between arms - Arm A: Single-agent Everolimus 10 mg QD and Arm C: Combination of MLN0128 4 mg QD + MLN1117 200 mg QD only.|As prespecified in protocol, the statistical analysis was performed between arms - Arm A: Single-agent Everolimus 10 mg QD and Arm C: Combination of MLN0128 4 mg QD + MLN1117 200 mg QD only for this outcome measure.|2.22|0.08|
70909844|NCT02724020|141307834|SUPERIORITY||Odds Ratio (OR)|0.64|||||TWO_SIDED|95.0|0.24|1.69|||||Odds ratio and 95% CI was obtained using a stratified CMH model with prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category.|||1.69|0.24|
70909845|NCT02724020|141307834|SUPERIORITY||Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.28|2.21|||||Odds ratio and 95% CI was obtained using a stratified CMH model with prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category.|||2.21|0.28|
70909846|NCT02724020|141307835|SUPERIORITY||Odds Ratio (OR)|0.47|||||TWO_SIDED|95.0|0.16|1.38|||||Odds ratio and 95% CI was obtained using a stratified CMH model with prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category.|||1.38|0.16|
70909847|NCT02724020|141307835|SUPERIORITY||Odds Ratio (OR)|0.6|||||TWO_SIDED|95.0|0.2|1.8|||||Odds ratio and 95% CI was obtained using a stratified CMH model with prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category.|||1.80|0.20|
70909848|NCT00688259|141307837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Mixed Models Analysis|||||||.30
70909849|NCT00688259|141307838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09|||||||Mixed Models Analysis|||||||.09
70909850|NCT00688259|141307839|SUPERIORITY_OR_OTHER_LEGACY|||||||0.46|||||||Mixed Models Analysis|||||||.46
70909851|NCT00688259|141307840|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55|||||||Mixed Models Analysis|||||||.55
70909852|NCT00688259|141307841|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Mixed Models Analysis|||||||.50
70909853|NCT00688259|141307842|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|||||||Mixed Models Analysis|||||||.25
70909854|NCT02954575|141307843|OTHER||Poisson test estimate|2.13|||<|0.0001|TWO_SIDED|95.0|1.64|2.76||versus mean TABR \>29|Poisson test estimate|||A confirmative one-sided, one-sample Poisson test was used to test whether the mean annualized bleeding rate (ABR) in patients treated prophylactically with Wilate was below the threshold of 29 BEs per patient year (alpha = 2.5%). This threshold corresponds to 50% of the TABR reported in the GENA-01 study (NCT00989196), which observed 58.1 BEs per patient per year. A corresponding two-sided 95% CI for the TABR was also analyzed.||2.76|1.64|<0.0001
70909855|NCT02954575|141307844|OTHER||Poisson test estimate|1.53|||<|0.0001|TWO_SIDED|95.0|1.13|2.08||versus mean SABR \>19.1|Poisson test estimate|||A confirmative one-sided, one-sample Poisson test was used to test whether the mean SABR in patients treated prophylactically with Wilate was below the threshold of 19.1 BEs per patient year (alpha = 2.5%). This threshold corresponds to 50% of the SABR in the GENA-01 study (NCT00989196), which observed 38.2 spontaneous BEs per patient per year. A corresponding two-sided 95% CI for the SABR was also analyzed.||2.08|1.13|<0.0001
70909856|NCT02954575|141307845|OTHER||Generalized estimation equation|84.21||||0.0096|TWO_SIDED|95.0|72.13|92.52|||Confirmatory data analysis|||"Confirmatory statistical testing tested the null hypotheses that the percentage of success is ≤70% (alternative hypothesis: percentage \>70%); the test procedure based on the generalized estimation equation took into account several BEs in one patient as correlated repeated measurements (alpha = 2.5%). Thus, π denotes the proportion of success and the following pair of hypotheses was tested:~H0: π ≤ 0.7 vs. H1: π \> 0.7"||92.52|72.13|0.0096
70909857|NCT02954575|141307851|OTHER|||||||0.0346|||||||ANOVA|||||||0.0346
70909858|NCT02954575|141307852|OTHER|||||||0.4244|||||||ANOVA|||||||0.4244
70909859|NCT02954575|141307854|OTHER||Pearson-Copper|0.0|||||TWO_SIDED|95.0|0.0|16.11||||||||16.11|0|
70909860|NCT03890120|141307917|SUPERIORITY||Difference in Percentages|-1.4||||0.4186|TWO_SIDED|95.0|-15.2|12.3|||Mantel Haenszel||The difference of cilofexor and placebo,95% confidence interval(CI),and P value(1-sided)were obtained by the stratum-adjusted Mantel-Haenszel (MH) method,with baseline ursodeoxycholic acid(UDCA)use and Ludwig fibrosis stage as stratification factors.|||12.3|-15.2|0.4186
70909861|NCT03890120|141307922|SUPERIORITY||Difference in Least Squares Mean (LSM)|-4.0||||0.3884|TWO_SIDED|95.0|-28.0|21.0|||ANCOVA||The LSM,95% CI and P-value(1-sided) were obtained by an analysis of covariance(ANCOVA)model with change at Week 96 as dependent variable,baseline value of outcome measure,baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.|||21|-28|0.3884
70909862|NCT03890120|141307923|SUPERIORITY||Difference in LSM|-9.0||||0.039|TWO_SIDED|95.0|-20.0|1.0|||ANCOVA||The LSM, 95% CI and P-value (1-sided) were obtained by ANCOVA model to evaluate change at Week 96 as the dependent variable, baseline value of the outcome measure, baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.|||1|-20|0.0390
70909863|NCT03890120|141307924|SUPERIORITY||Difference in LSM|-2.6||||0.2845|TWO_SIDED|95.0|-11.6|6.4|||ANCOVA||The LSM, 95% CI and P-value (1-sided) were obtained by ANCOVA model to evaluate change at Week 96 as the dependent variable, baseline value of the outcome measure, baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.|||6.4|-11.6|0.2845
70909864|NCT03890120|141307925|SUPERIORITY||Difference in Percentages|4.1||||0.1978|TWO_SIDED|95.0|-5.3|13.5|||Mantel Haenszel||The difference between cilofexor and Placebo, 95% CI, and the p-value (1-sided) were obtained by the stratum-adjusted MH method, with baseline UDCA use and Ludwig fibrosis stage as stratification factors.|||13.5|-5.3|0.1978
70909865|NCT03890120|141307926|SUPERIORITY||Difference in Percentages|8.9||||0.0797|TWO_SIDED|95.0|-3.5|21.2|||Mantel Haenszel||The difference between cilofexor and Placebo, 95% CI, and the p-value (1-sided) were obtained by the stratum-adjusted MH method, with baseline UDCA use and Ludwig fibrosis stage as stratification factors.|||21.2|-3.5|0.0797
70909866|NCT03890120|141307927|SUPERIORITY||Difference in LSM|1.0||||0.7275|TWO_SIDED|95.0|-1.0|3.0|||ANCOVA||The LSM, 95% CI and P-value (1-sided) were obtained by ANCOVA model to evaluate change at Week 96 as the dependent variable, baseline value of the outcome measure, baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.|||3|-1|0.7275
70909867|NCT03890120|141307928|SUPERIORITY||Difference in LSM|-0.03||||0.3636|TWO_SIDED|95.0|-0.2|0.14|||ANCOVA||The LSM, 95% CI and P-value (1-sided) were obtained by ANCOVA model to evaluate change at Week 96 as the dependent variable, baseline value of the outcome measure, baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.|||0.14|-0.20|0.3636
70909868|NCT03890120|141307929|SUPERIORITY||Difference in LSM|-0.3||||0.3595|TWO_SIDED|95.0|-2.2|1.5|||ANCOVA||The LSM, 95% CI and P-value (1-sided) were obtained by ANCOVA model to evaluate change at Week 96 as the dependent variable, baseline value of the outcome measure, baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.|||1.5|-2.2|0.3595
70909869|NCT04081298|141307952|EQUIVALENCE|feasibility assessment|Mean Difference (Final Values)|0.24|STANDARD_DEVIATION|0.8||0.24|TWO_SIDED|||||The threshold for statistical significance is p=0.05. (feasibility assessment)|Paired sample t-test|||||||0.24
70909870|NCT04081298|141307953|EQUIVALENCE|feasibility assessment|Mean Difference (Final Values)|0.14|STANDARD_DEVIATION|0.78||0.43|TWO_SIDED|||||The threshold for statistical significance was p=0.5 (feasibility assessment)|paired t-test|||||||0.43
70909871|NCT04081298|141307954|EQUIVALENCE|McNemar's test evaluates equivalence between nominal groups. Power not calculated as this is a feasibility study with small sample size.||||||0.1|||||||McNemar|||Single arm pre-post comparison at baseline and 3-month follow-up (feasibility study)||||0.10
70909872|NCT04081298|141307955|EQUIVALENCE|feasibility assessment|Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|0.65||0.2|TWO_SIDED|||||The threshold for statistical significance was p=0.5 (feasibility assessment)|paired-sample t-test|||||||0.20
70909873|NCT04081298|141307956|EQUIVALENCE|paired sample t-test (feasibility assessment)|Mean Difference (Final Values)|0.06|STANDARD_DEVIATION|0.73||0.71|TWO_SIDED||||||paired sample t-test|||||||0.71
70909874|NCT04081298|141307957|EQUIVALENCE|The analysis is an equivalence analysis of change (H1) in mean value from baseline to 3 month follow-up. Power was not calculated for this analysis because this is a feasibility study. The sample size is not large enough to approach appropriate power.||||||0.94|||||||paired-sample t-test|||Single arm pre-post comparison at baseline and 3-month follow-up (feasibility study)||||0.94
70909875|NCT04081298|141307958|EQUIVALENCE|The analysis is an equivalence analysis of change (H1) in mean value from baseline to 3 month follow-up using a paired-sample t-test. Power was not calculated for this analysis because this is a feasibility study. The sample size is not large enough to approach appropriate power.||||||0.03|||||||paired-sample t-test|||||||0.03
70909876|NCT04081298|141307959|EQUIVALENCE|The analysis is an equivalence analysis of change (H1) in mean value from baseline to 3 month follow-up using a paired-sample t-test. Power was not calculated for this analysis because this is a feasibility study. The sample size is not large enough to approach appropriate power.||||||0.36|||||||paired-sample t-test|||||||0.36
70909877|NCT02059161|141307985|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for declaring non-inferiority was for the upper bound of the 95% CI to lie below 0.4%.|Difference in the Least Squares Means|0.04|||||TWO_SIDED|95.0|-0.11|0.19|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.19|-0.11|
70909878|NCT02059161|141307986|SUPERIORITY_OR_OTHER||Difference in the Percentages|-3.9|||||TWO_SIDED|95.0|-11.8|4.0|||||Miettinen \& Nurminen|||4.0|-11.8|
70909879|NCT02059161|141307987|SUPERIORITY_OR_OTHER||Difference in Percentages|-3.0|||||TWO_SIDED|95.0|-16.1|10.1|||||Miettinen \& Nurminen|||10.1|-16.1|
70909880|NCT02059161|141307990|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.02|||||TWO_SIDED|95.0|-0.18|0.14|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.14|-0.18|
70909881|NCT02059161|141307991|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-1.77|||||TWO_SIDED|95.0|-4.69|1.16|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||1.16|-4.69|
70909882|NCT02059161|141307992|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.02|||||TWO_SIDED|95.0|-0.06|0.01|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.01|-0.06|
71031259|NCT02087904|141570750|SUPERIORITY||LS Mean Difference|-0.15||||0.095|TWO_SIDED|95.0|-0.324|0.026||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.026|-0.324|0.095
70909883|NCT02059161|141307993|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|9.6|||||TWO_SIDED|95.0|-3.0|22.2|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||22.2|-3.0|
70909884|NCT02059161|141307994|SUPERIORITY_OR_OTHER||Differences in Percentages|-2.1|||||TWO_SIDED|95.0|-9.8|5.5|||||Miettinen \& Nurminen|||5.5|-9.8|
70909885|NCT02059161|141307995|SUPERIORITY_OR_OTHER||Difference in Percentages|0.8|||||TWO_SIDED|95.0|-12.8|14.3|||||Miettinen \& Nurminen|||14.3|-12.8|
70909886|NCT02059161|141307997|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.77|||||TWO_SIDED|95.0|-4.92|1.39|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||1.39|-4.92|
70909887|NCT02059161|141307998|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.02|||||TWO_SIDED|95.0|-0.05|0.02|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.02|-0.05|
70909888|NCT02059161|141307999|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-5.4|||||TWO_SIDED|95.0|-19.7|8.9|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||8.9|-19.7|
70909889|NCT02059161|141308001|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.4|||||TWO_SIDED|95.0|-8.9|8.2|||||Longitudinal data analysis model including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||8.2|-8.9|
70909890|NCT02059161|141308002|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-8.1|||||TWO_SIDED|95.0|-18.6|2.4|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||2.4|-18.6|
70909891|NCT02059161|141308003|SUPERIORITY_OR_OTHER||Adjusted Difference in %s (A1C < 7.0%)|-0.8|||||TWO_SIDED|95.0|-9.7|8.1|||||Miettinen and Nurminen, stratified by prior insulin status.|||8.1|-9.7|
70909892|NCT02059161|141308003|SUPERIORITY_OR_OTHER||Adjusted Difference in %s (A1C <6.5%)|-1.1|||||TWO_SIDED|95.0|-8.6|6.5|||||Miettinen and Nurminen, stratified by prior insulin status.|||6.5|-8.6|
70909893|NCT02059161|141308004|SUPERIORITY_OR_OTHER||Adjusted Difference (A1C < 7.0%)|0.2|||||TWO_SIDED|95.0|-8.7|9.1|||||Miettinen and Nurminen|||9.1|-8.7|
70909894|NCT02059161|141308004|SUPERIORITY_OR_OTHER||Adjusted Difference (A1C < 6.5%)|-4.4|||||TWO_SIDED|95.0|-11.5|2.8|||||Miettinen and Nurminen|||2.8|-11.5|
70909895|NCT02059161|141308005|SUPERIORITY_OR_OTHER||Difference in Least Means Squares|-0.42|||||TWO_SIDED|95.0|-2.33|1.48|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||1.48|-2.33|
70909896|NCT02059161|141308006|SUPERIORITY_OR_OTHER||Difference in Least Means Squares|0.0|||||TWO_SIDED|95.0|-0.02|0.02|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.02|-0.02|
70909897|NCT02059161|141308007|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-1.5|||||TWO_SIDED|95.0|-3.69|0.69|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.69|-3.69|
70909898|NCT02059161|141308008|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.02||||||95.0|-0.04|0.01|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.01|-0.04|
70909899|NCT02059161|141308009|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.74|||||TWO_SIDED|95.0|-2.52|1.04|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||1.04|-2.52|
70909900|NCT02059161|141308010|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.01|||||TWO_SIDED|95.0|-0.03|0.01|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.01|-0.03|
70909901|NCT02059161|141308011|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-1.25|||||TWO_SIDED|95.0|-3.34|0.83|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.83|-3.34|
70909902|NCT02059161|141308012|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.02|||||TWO_SIDED|95.0|-0.04|0.01|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.01|-0.04|
70909903|NCT01818700|141308028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.65|STANDARD_DEVIATION|1.96|<|0.05|TWO_SIDED|95.0|-10.0|10.0|||t-test, 2 sided|"The primary endpoint will be the actual reduction rate of pain intensity (0 -10) score at 8 weeks.~It will be analyzed by using paired t-test."||||10|-10|<0.05
70909904|NCT01852955|141308034|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.01
70909905|NCT01852955|141308035|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.04
70909906|NCT01852955|141308036|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.36
70909907|NCT01656759|141308086|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||t-test, 2 sided|||||||0.2
70909908|NCT01656759|141308087|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||t-test, 2 sided|||||||0.9
70909909|NCT01656759|141308089|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||t-test, 2 sided|||||||0.9
71008715|NCT02055976|141525246|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.072|STANDARD_ERROR_OF_MEAN|1.773||0.484|TWO_SIDED|95.0|-3.596|3.451|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||3.451|-3.596|0.484
70909910|NCT02923895|141308116|SUPERIORITY|All statistical analyses were conducted under the null hypothesis (H0) of no difference between treatments versus the alternate hypothesis (H1) of a difference between treatments.|Mean Difference (Net)|-1.31|||<|0.0001|TWO_SIDED|95.0|-1.5|-1.128||From ANCOVA model with change from baseline in Schiff Sensitivity Score as response and treatment as a factor and baseline Schiff sensitivity score as a covariate.|ANCOVA||Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|||-1.128|-1.500|<.0001
70909911|NCT03552978|141308122|SUPERIORITY||Odds Ratio (OR)|11.6|||<|0.001|TWO_SIDED||||||t-test, 2 sided|df - 63||||||<.001
70909912|NCT03552978|141308123|SUPERIORITY||Mean Difference (Final Values)|3.57|||<|0.001|TWO_SIDED||||||t-test, 2 sided|df = 59||||||<.001
70909913|NCT03552978|141308127|SUPERIORITY||Mean Difference (Final Values)|90.28||||0.39|TWO_SIDED||||||Mixed Models Analysis|df = 3, 152.11||We examined total Cigarettes smoked in the past 30 days using linear mixed models to account for non-independence (longitudinal data) and missing data. The null hypothesis was that the time by treatment group interaction would equal zero, indicating no difference in the change in cigarette use over time by treatment group.||||.39
70909914|NCT03552978|141308128|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.91|TWO_SIDED||||||Mixed Models Analysis|df = 3, 140.87||We examined days of e-cigarette use in the previous 30 days using linear mixed models to account for non-independence (longitudinal data) and missing data. The null hypothesis was that the time by treatment group interaction would equal zero, indicating no difference in the change in e-cigarette use over time by treatment group.||||.91
70909915|NCT03552978|141308129|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.66|TWO_SIDED||||||Mixed Models Analysis|df = 3,199||We examined days of chewing tobacco use in the previous 30 days using linear mixed models to account for non-independence (longitudinal data) and missing data. The null hypothesis was that the time by treatment group interaction would equal zero, indicating no difference in the change in chewing tobacco use over time by treatment group.||||.66
70909916|NCT03552978|141308130|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.76|TWO_SIDED||||||Mixed Models Analysis|df = 3, 102.04||We examined nicotine dependence using linear mixed models to account for non-independence (longitudinal data) and missing data. The null hypothesis was that the time by treatment group interaction would equal zero, indicating no difference in the change in nicotine dependence over time by treatment group.||||.76
70909917|NCT03552978|141308131|SUPERIORITY||Odds Ratio (OR)|1.99||||0.28|TWO_SIDED|||||Week 12|Chi-squared|df = 1||||||.28
70909918|NCT03552978|141308131|SUPERIORITY||Odds Ratio (OR)|2.3||||0.19|TWO_SIDED|||||Week 24|Chi-squared|df = 1||||||.19
71031260|NCT02087904|141570750|SUPERIORITY||LS Mean Difference|-0.14||||0.106|TWO_SIDED|95.0|-0.314|0.03||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.03|-0.314|0.106
70909919|NCT03552978|141308132|SUPERIORITY||Odds Ratio (OR)|1.68||||0.42|TWO_SIDED||||||Chi-squared|df = 1||Week 12||||.42
70909920|NCT03552978|141308132|SUPERIORITY||Odds Ratio (OR)|2.52||||0.17|TWO_SIDED||||||Chi-squared|df = 1||Week 24||||.17
70909921|NCT03552978|141308133|SUPERIORITY||Mean Difference (Final Values)|3.66||||0.58|TWO_SIDED||||||Mixed Models Analysis|df = 3, 100.51||We examined days of changes in PTSD symptoms using linear mixed models to account for non-independence (longitudinal data) and missing data. The null hypothesis was that the time by treatment group interaction would equal zero, indicating no difference in the change in PTSD symptoms over time by treatment group.||||.58
71031261|NCT02087904|141570751|SUPERIORITY||LS Mean Difference|-1.1||||0.818|TWO_SIDED|95.0|-10.22|8.08||P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||8.08|-10.22|0.818
71031262|NCT02087904|141570751|SUPERIORITY||LS Mean Difference|-7.6||||0.109|TWO_SIDED|95.0|-16.83|1.69||P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||1.69|-16.83|0.109
70909922|NCT01670500|141308142|OTHER||Risk Ratio (RR)|0.7|||||TWO_SIDED|90.0|0.39|1.2|||||The risk ratio is comparing cisplatin to doxorubicin-cyclophosphamide (AC)|||1.2|0.39|
70909923|NCT01670500|141308143|OTHER||Risk Ratio (RR)|0.73|||||TWO_SIDED|90.0|0.5|1.1|||||The risk ratio is comparing cisplatin to doxorubicin-cyclophosphamide (AC)|||1.1|.5|
70909924|NCT02711826|141308175|SUPERIORITY|||||||0.425|||||||Fisher Exact|||||||0.425
70909925|NCT02711826|141308176|SUPERIORITY|||||||0.7|||||||Kruskal-Wallis|||||||0.700
70909926|NCT02711826|141308177|SUPERIORITY|||||||0.201|||||||Kruskal-Wallis|||||||0.201
70909927|NCT04019561|141308220|SUPERIORITY||Mean Difference (Final Values)|-1.41||||0.439|TWO_SIDED|95.0|-5.02|2.2|||ANCOVA|||||2.20|-5.02|0.439
70909928|NCT04019561|141308220|SUPERIORITY||Mean Difference (Final Values)|-5.01||||0.006|TWO_SIDED|95.0|-8.54|-1.48|||ANCOVA|||||-1.48|-8.54|0.006
70909929|NCT04019561|141308221|SUPERIORITY||Mean Difference (Final Values)|-1.508||||0.695|TWO_SIDED|95.0|-9.191|6.174|||ANCOVA|||||6.174|-9.191|0.695
70909930|NCT04019561|141308221|SUPERIORITY||Mean Difference (Final Values)|-9.291||||0.016|TWO_SIDED|95.0|-16.76|-1.822|||ANCOVA|||||-1.822|-16.760|0.016
70909931|NCT04019561|141308222|SUPERIORITY||Mean Difference (Final Values)|-10.74||||0.468|TWO_SIDED|95.0|-40.174|18.695|||ANCOVA|||||18.695|-40.174|0.468
70909932|NCT04019561|141308222|SUPERIORITY||Mean Difference (Final Values)|-37.395||||0.012|TWO_SIDED|95.0|-66.38|-8.409|||ANCOVA|||||-8.409|-66.380|0.012
70909933|NCT04019561|141308223|SUPERIORITY||Mean Difference (Final Values)|6.26||||0.166|TWO_SIDED|95.0|-2.698|15.218|||ANCOVA|||||15.218|-2.698|0.166
70909934|NCT04019561|141308223|SUPERIORITY||Mean Difference (Final Values)|0.749||||0.856|TWO_SIDED|95.0|-7.537|9.035|||ANCOVA|||||9.035|-7.537|0.856
70909935|NCT04019561|141308224|SUPERIORITY||Mean Difference (Final Values)|-3.283||||0.302|TWO_SIDED|95.0|-9.641|3.076|||ANCOVA|||||3.076|-9.641|0.302
70909936|NCT04019561|141308224|SUPERIORITY||Mean Difference (Final Values)|-2.821||||0.304|TWO_SIDED|95.0|-8.316|2.675|||ANCOVA|||||2.675|-8.316|0.304
70909937|NCT04019561|141308225|SUPERIORITY||Mean Difference (Final Values)|1.038||||0.808|TWO_SIDED|95.0|-7.493|9.569|||ANCOVA|||||9.569|-7.493|0.808
70909938|NCT04019561|141308225|SUPERIORITY||Mean Difference (Final Values)|1.106||||0.786|TWO_SIDED|95.0|-7.043|9.255|||ANCOVA|||||9.255|-7.043|0.786
70909939|NCT04019561|141308226|SUPERIORITY||Mean Difference (Final Values)|3.448||||0.087|TWO_SIDED|95.0|-0.524|7.421|||ANCOVA|||||7.421|-0.524|0.087
70909940|NCT04019561|141308226|SUPERIORITY||Mean Difference (Final Values)|-0.387||||0.834|TWO_SIDED|95.0|-4.085|3.312|||ANCOVA|||||3.312|-4.085|0.834
70909941|NCT04019561|141308227|SUPERIORITY||Mean Difference (Final Values)|-0.386||||0.735|TWO_SIDED|95.0|-2.681|1.908|||ANCOVA|||||1.908|-2.681|0.735
70909942|NCT04019561|141308227|SUPERIORITY||Mean Difference (Final Values)|-1.091||||0.308|TWO_SIDED|95.0|-3.226|1.044|||ANCOVA|||||1.044|-3.226|0.308
70909943|NCT04019561|141308228|SUPERIORITY||Mean Difference (Final Values)|-19.277||||0.195|TWO_SIDED|95.0|-48.704|10.15|||ANCOVA|||||10.150|-48.704|0.195
70909944|NCT04019561|141308228|SUPERIORITY||Mean Difference (Final Values)|-24.328||||0.103|TWO_SIDED|95.0|-53.674|5.019|||ANCOVA|||||5.019|-53.674|0.103
70909945|NCT04019561|141308229|SUPERIORITY||Mean Difference (Final Values)|-10.39||||0.6|TWO_SIDED|95.0|-49.802|29.022|||ANCOVA|||||29.022|-49.802|0.600
70909946|NCT04019561|141308229|SUPERIORITY||Mean Difference (Final Values)|7.086||||0.72|TWO_SIDED|95.0|-32.163|46.336|||ANCOVA|||||46.336|-32.163|0.720
70909947|NCT04019561|141308230|SUPERIORITY||Mean Difference (Final Values)|-9.14||||0.485|TWO_SIDED|95.0|-35.134|16.854|||ANCOVA|||||16.854|-35.134|0.485
71031263|NCT02087904|141570751|SUPERIORITY||LS Mean Difference|-3.4||||0.465|TWO_SIDED|95.0|-12.58|5.76||P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||5.76|-12.58|0.465
70909948|NCT04019561|141308230|SUPERIORITY||Mean Difference (Final Values)|-19.645||||0.131|TWO_SIDED|95.0|-45.288|5.999|||ANCOVA|||||5.999|-45.288|0.131
70909949|NCT04019561|141308231|SUPERIORITY||Mean Difference (Final Values)|-0.719||||0.564|TWO_SIDED|95.0|-3.191|1.754|||ANCOVA|||||1.754|-3.191|0.564
70909950|NCT04019561|141308231|SUPERIORITY||Mean Difference (Final Values)|-2.366||||0.062|TWO_SIDED|95.0|-4.854|0.122|||ANCOVA|||||0.122|-4.854|0.062
70909951|NCT04019561|141308232|SUPERIORITY||Mean Difference (Final Values)|-0.084||||0.856|TWO_SIDED|95.0|-1.007|0.838|||ANCOVA|||||0.838|-1.007|0.856
70909952|NCT04019561|141308232|SUPERIORITY||Mean Difference (Final Values)|-0.777||||0.098|TWO_SIDED|95.0|-1.7|0.147|||ANCOVA|||||0.147|-1.700|0.098
70909953|NCT01778062|141308287|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
70909954|NCT01824472|141308291|SUPERIORITY||Mean difference compared across 3 groups|0.43||||0.8|TWO_SIDED||||||Kruskal-Wallis||"Kruskal-Wallis test implemented as PROC NPAR1WAY in Statistical Analysis System (SAS v9.4) for a single groupwise comparison. The mean difference (baseline to follow-up) was determined for each group, and this was compared across all 3 groups."|||||0.8
70909955|NCT01815736|141308297|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Null hypothesis: the E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.|Difference in percentages|2.7||||0.051|TWO_SIDED|95.01|-0.3|5.6||The p-value for the superiority test used a 2-sided Cochran-Mantel-Haenszel (CMH) test, stratified by prior treatment regimen.|Cochran-Mantel-Haenszel||The difference in percentages and its 95.01% confidence interval (CI) were calculated based on the Mantel-Haenszel (MH) proportion adjusted by the prior treatment regimen.|NDA Data Cut||5.6|-0.3|0.051
70909956|NCT01815736|141308297|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Null hypothesis: the E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.|Difference in percentages|4.1|||<|0.001|TWO_SIDED|95.0|1.6|6.7||The p-value for the superiority test used a 2-sided Cochran-Mantel-Haenszel (CMH) test, stratified by prior treatment regimen.|Cochran-Mantel-Haenszel||The difference in percentages and its 95% confidence interval (CI) were calculated based on the Mantel-Haenszel (MH) proportion adjusted by the prior treatment regimen.|All Participants||6.7|1.6|<0.001
70909957|NCT01815736|141308298|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|2.078|||<|0.001|TWO_SIDED|95.0|1.697|2.459||P-value was from the analysis of variance (ANOVA) model including study treatment and prior treatment regimen as fixed effects.|ANOVA||Difference in least squares means (LSM) and its 95% CI were from the ANOVA model including treatment and prior treatment regimen as fixed effects.|NDA Data Cut||2.459|1.697|<0.001
70909958|NCT01815736|141308298|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|1.807|||<|0.001|TWO_SIDED|95.0|1.488|2.126||P-value was from the analysis of variance (ANOVA) model including study treatment and prior treatment regimen as fixed effects.|ANOVA||Difference in least squares means and its 95% CI were from the ANOVA model including treatment and prior treatment regimen as fixed effects.|All Participants||2.126|1.488|<0.001
70909959|NCT01815736|141308299|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|1.97|||<|0.001|TWO_SIDED|95.0|1.551|2.39||P-value was from the analysis of variance (ANOVA) model including study treatment and prior treatment regimen as fixed effects.|ANOVA||Difference in least squares means (LSM) and its 95% CI were from the ANOVA model including treatment and prior treatment regimen as fixed effects.|NDA Data Cut||2.390|1.551|<0.001
70909960|NCT01815736|141308299|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|2.0|||<|0.001|TWO_SIDED|95.0|1.549|2.452||P-value was from the analysis of variance (ANOVA) model including study treatment and prior treatment regimen as fixed effects.|ANOVA||Difference in least squares means (LSM) and its 95% CI were from the ANOVA model including treatment and prior treatment regimen as fixed effects.|All Participants||2.452|1.549|<0.001
70909961|NCT01815736|141308300|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.05|||<|0.001|TWO_SIDED|95.0|-0.07|-0.03||P-value was from analysis of covariance (ANCOVA) model including study treatment and prior treatment as fixed effects and baseline serum creatinine as a covariate.|ANCOVA||Difference in least squares means (LSM) and its 95% CI were from the analysis of covariance (ANCOVA) model including study treatment and prior treatment regimen as fixed effects and baseline serum creatinine as a covariate.|NDA Data Cut||-0.03|-0.07|<0.001
70909962|NCT01815736|141308300|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.04|||<|0.001|TWO_SIDED|95.0|-0.05|-0.02||P-value was from analysis of covariance (ANCOVA) model including study treatment and prior treatment as fixed effects and baseline serum creatinine as a covariate.|ANCOVA||Difference in least squares means (LSM) and its 95% CI were from the analysis of covariance (ANCOVA) model including study treatment and prior treatment regimen as fixed effects and baseline serum creatinine as a covariate.|All Participants||-0.02|-0.05|<0.001
70909963|NCT01815736|141308301|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||The P-value comparing the 2 treatment groups was from the 2-sided Wilcoxon rank sum test.|Wilcoxon (Mann-Whitney)|||NDA Data Cut||||<0.001
70909964|NCT01815736|141308301|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||The P-value comparing the 2 treatment groups was from the 2-sided Wilcoxon rank sum test.|Wilcoxon (Mann-Whitney)|||All Participants||||<0.001
70909965|NCT01815736|141308302|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Null hypothesis: The E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.|Difference in percentages|3.7||||0.017|TWO_SIDED|95.0|0.4|7.0||P-value for the superiority test comparing the percentages of virologic success was from the CMH test stratified by the prior treatment regimen (STB, ATR, ATV/boosted+TVD).|Cochran-Mantel-Haenszel||The difference in percentages of virologic success and its 95% CI were calculated based on the MH proportion adjusted by the prior treatment regimen.|||7.0|0.4|0.017
70909966|NCT01815736|141308303|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Null hypothesis: The E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.|Difference in percentages|1.8||||0.29|TWO_SIDED|95.0|-1.7|5.3||P-value for the superiority test comparing the percentages of virologic success was from the CMH test stratified by the prior treatment regimen (STB, ATR, ATV/boosted+TVD).|Cochran-Mantel-Haenszel||Difference in percentages of virologic success and its 95% CI were calculated based on the MH proportion adjusted by the prior treatment regimen.|NDA Data Cut||5.3|-1.7|0.29
70909967|NCT01815736|141308303|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Null hypothesis: the E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.|Difference in percentages|3.2||||0.031|TWO_SIDED|95.0|0.1|6.3||P-value for the superiority test comparing the percentages of virologic success was from the CMH test stratified by the prior treatment regimen (STB, ATR, ATV/boosted+TVD).|Cochran-Mantel-Haenszel||Difference in percentages of virologic success and its 95% CI were calculated based on the MH proportion adjusted by the prior treatment regimen.|All Participants||6.3|0.1|0.031
70909968|NCT01815736|141308304|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Null hypothesis: the E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.|Difference in percentages|5.3||||0.003|TWO_SIDED|95.0|1.6|9.0||P-value for the superiority test comparing the percentages of virologic success was from the CMH test stratified by the prior treatment regimen (STB, ATR, ATV/boosted+TVD).|Cochran-Mantel-Haenszel||Difference in percentages of virologic success and its 95% CI were calculated based on the MH proportion adjusted by the prior treatment regimen.|||9.0|1.6|0.003
70909969|NCT01815736|141308305|SUPERIORITY||Difference in least squares means|6.0||||0.56|TWO_SIDED|95.0|-14.0|26.0||P-values were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs. SBR) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.|ANOVA||Difference in least squares means (Diff in LSM), and its 95% CI were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs. FTC/TDF+3rd Agent) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.|NDA Data Cut: Change at Week 48||26|-14|0.56
70909970|NCT01815736|141308305|SUPERIORITY||Difference in least squares means|11.0||||0.26|TWO_SIDED|95.0|-8.0|29.0||P-values were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs. SBR) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.|ANOVA||Difference in least squares means and its 95% CI were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs.SBR) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.|All Participants: Change at Week 48||29|-8|0.26
70909971|NCT01815736|141308306|SUPERIORITY||Difference in least squares means|18.0||||0.074|TWO_SIDED|95.0|-2.0|38.0||P-values were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs. SBR) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.|ANOVA||Difference in least squares means and its 95% CI were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs. SBR) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.|||38|-2|0.074
70909972|NCT01646320|141308365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.0964|<|0.0001|TWO_SIDED|95.0|-0.91|-0.53||Tested at alpha=0.05|Longitudinal Repeated Measures Analysis|||||-0.53|-0.91|<0.0001
70909973|NCT01646320|141308366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.5|STANDARD_ERROR_OF_MEAN|4.015|<|0.0001|TWO_SIDED|95.0|-35.4|-19.6||Secondary end points are tested following a sequential testing procedure at alpha=0.05|Longitudinal Repeated Measures Analysis|||||-19.6|-35.4|<0.0001
70909974|NCT01646320|141308367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.5|STANDARD_ERROR_OF_MEAN|5.493|<|0.0001|TWO_SIDED|95.0|-46.3|-24.7||Secondary end points are tested following a sequential testing procedure at alpha=0.05|Longitudinal Repeated Measures Analysis|||||-24.7|-46.3|<0.0001
70909975|NCT01646320|141308368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.3126|<|0.0001|TWO_SIDED|95.0|-2.12|-0.89||Secondary endpoints are tested following a sequential testing procedure at alpha=0.05|Longitudinal Repeated Measures Analysis|||||-0.89|-2.12|<0.0001
70909976|NCT01646320|141308369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.5|||<|0.0001|TWO_SIDED|95.0|16.7|34.4||Secondary end points are tested following a sequential testing procedure at alpha=0.05|Modified logistic regression|||||34.4|16.7|<0.0001
70909977|NCT02424344|141308374|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.125||||0.069|TWO_SIDED|95.0|-0.259|0.01|||ANCOVA|Adjusted by baseline and age as covariates, and treatment group, sex and smoking-status as fixed effect factors||||0.010|-0.259|0.069
70909978|NCT05257837|141308390|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
70909979|NCT05257837|141308391|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
70909980|NCT05257837|141308392|SUPERIORITY|||||||0.012|||||||t-test, 2 sided|||||||.012
70909981|NCT05257837|141308394|SUPERIORITY|||||||0.217|||||||t-test, 2 sided|||||||.217
70909982|NCT05257837|141308395|SUPERIORITY|||||||0.745|||||||t-test, 2 sided|||||||.745
70909983|NCT02037061|141308418|OTHER|||||||0.83|||||||t-test, 2 sided|||||||0.83
70909984|NCT02033993|141308439|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.31|TWO_SIDED|90.0|0.68|1.23||1-sided p-value|Log Rank|||||1.23|0.68|0.31
70909985|NCT02033993|141308440|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.4|TWO_SIDED|90.0|0.7|1.3||1-sided p-value|Log Rank|||||1.30|0.70|0.40
70909986|NCT02033993|141308441|SUPERIORITY||Odds Ratio (OR)|1.41||||0.28|TWO_SIDED|95.0|0.76|2.59|||Cochran-Mantel-Haenszel|||||2.59|0.76|0.28
70909987|NCT02033993|141308442|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.54|TWO_SIDED|95.0|0.46|1.51|||Log Rank|||||1.51|0.46|0.54
70909988|NCT01207934|141308446|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||ANOVA for reapeated measures was used to compare the three groups.|ANOVA|||The null hypothesis was that there would be no change in glucose disposal between the three groups (placebo, low dose leptin, and high dose leptin). Power calculations were done showing that 6 subjects in each arm was enough to detect a 35% between group difference in glucose disposal at the 0.05 level with 80% power.||||>0.05
70909989|NCT01207934|141308447|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||a priori threshold for significance was set at p = 0.05.|t-test, 2 sided|T-tests compared pre and post-treatment values.||The null hypothesis is that treatment would not effect plasma leptin levels.||||<0.01
70909990|NCT01207934|141308447|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||a priori threshold for significance was p = 0.05.|t-test, 2 sided|||null hypothesis was that plasma leptin levels would be equal after treatment in the placebo and high-dose leptin groups.||||<0.01
70909991|NCT01272011|141308529|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Two-way RMANOVA Student-Newman-Keuls|||Daily acute and cumulative Pre vs Post comparisons||||<0.001
70909992|NCT01272011|141308530|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||RMANOVA and Student-Neuman-Keuls|||Compared outcomes from Baseline versus Post-Day 10 IH for mean slope of AF vs. Resistance||||<0.05
70909993|NCT01272011|141308530|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||RMANOVA and Student-Neuman-Keuls|||Compared outcomes from Baseline versus Post-Day 10 IH for mean slope of of Pressure vs. Resistance||||<0.05
71031264|NCT02087904|141570752|SUPERIORITY||LS Mean Difference|-2.1||||0.666|TWO_SIDED|95.0|-11.76|7.52||P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||7.52|-11.76|0.666
70909994|NCT02013687|141308540|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significance of IgG values at study day 196 as compared to day 0 (pre-immune).|Wilcoxon (Mann-Whitney)|||||||<0.001
70909995|NCT02013687|141308540|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significance of IgG values at study day 196 as compared to day 0 (pre-immune).|Wilcoxon (Mann-Whitney)|||||||<0.001
70909996|NCT02013687|141308541|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
70909997|NCT02013687|141308541|SUPERIORITY_OR_OTHER|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.6
70909998|NCT02013687|141308542|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
70909999|NCT02013687|141308542|SUPERIORITY_OR_OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
70910000|NCT01657032|141308543|NON_INFERIORITY_OR_EQUIVALENCE|The differences between the study groups were considered significant when the P value was \<0.05.||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
70910001|NCT03633903|141308554|SUPERIORITY||Mean Difference (Final Values)|1.04|||<|0.05|TWO_SIDED|||||"The reported p-value was calculated and is not indicating a threshold for significance.~This applies to the change from row 1 to row 3 (e.g., baseline pre TSST-C versus follow-up timepoint pre TSST-C)"|Mixed Models Analysis|||||||<.05
70910002|NCT03633903|141308554|SUPERIORITY||Mean Difference (Final Values)|0.77|||<|0.05|TWO_SIDED|||||"The reported p-value was calculated and is not indicating a threshold for significance.~This is for the difference from row 1 to row 2 (baseline pre versus baseline post TSST-C)"|Mixed Models Analysis|||||||<.05
70910003|NCT03633903|141308554|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.4|TWO_SIDED|||||"The reported p-value was calculated and is not indicating a threshold for significance.~Comparing row 1 and row 4 (baseline pre TSST-C versus follow-up post TSST-C)."|Mixed Models Analysis|||||||0.40
70910004|NCT03633903|141308555|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.39|TWO_SIDED||||||Mixed Models Analysis|||Comparing group differences (CRP biomarker) in mindfulness versus control at baseline versus follow-up timepoints.||||.39
70910005|NCT03633903|141308555|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.95|TWO_SIDED||||||Mixed Models Analysis|||Comparing group differences (IL-6 biomarker) in mindfulness versus control at baseline versus follow-up timepoints.||||.95
70910006|NCT03633903|141308556|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.08|TWO_SIDED|||||the calculated p value.|Mixed Models Analysis|||Comparing group differences (symptoms of anxiety/depression) in mindfulness versus control at baseline versus follow-up timepoints.||||.08
70910007|NCT01925170|141308589|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison of the two groups for all densities, significant difference p ≤ 0.05.||||<0.001
70910008|NCT01925170|141308589|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||Comparison of two groups for all densities; significant difference p ≤ 0.05.||||0.004
70910009|NCT01925170|141308590|SUPERIORITY_OR_OTHER||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05||||<0.001
70910010|NCT01925170|141308590|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||McNemar|||Significant difference p ≤ 0.05||||<0.0001
70910011|NCT01925170|141308591|SUPERIORITY_OR_OTHER||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05||||< 0.001
70910012|NCT01925170|141308591|SUPERIORITY_OR_OTHER|||||||0.004|||||||McNemar|||Significant difference p ≤ 0.05||||0.004
70910013|NCT01925170|141308592|SUPERIORITY_OR_OTHER||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05||||< 0.001
70910014|NCT01925170|141308592|SUPERIORITY_OR_OTHER||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05||||<0.001
70910015|NCT01925170|141308593|SUPERIORITY_OR_OTHER||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05||||<0.001
70910016|NCT01925170|141308593|SUPERIORITY_OR_OTHER||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05||||<0.001
70910017|NCT00577720|141308604|SUPERIORITY_OR_OTHER||Ratio (LS Mean 35 mg DRFB/35 mg IRBB)|1.437|||||TWO_SIDED|90.0|1.091|1.964||||||For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.||1.964|1.091|
70910018|NCT00577720|141308604|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRBB/35 mg IRBB)|1.507|||||TWO_SIDED|90.0|1.139|2.066||||||For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.||2.066|1.139|
70910019|NCT00577720|141308604|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/35 mg IRBB)|1.535|||||TWO_SIDED|90.0|1.177|2.086||||||For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.||2.086|1.177|
70910020|NCT00577720|141308604|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/50 mg DRBB)|1.068|||||TWO_SIDED|90.0|0.867|1.321||||||For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.||1.321|0.867|
70910021|NCT00577720|141308604|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/50 mg DRBB)|1.018|||||TWO_SIDED|90.0|0.824|1.267||||||For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.||1.267|0.824|
70910022|NCT00577720|141308605|SUPERIORITY_OR_OTHER||Ratio (LS Mean 35 mg DRFB/35 mg IRBB)|1.208|||||TWO_SIDED|90.0|0.749|2.099||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||2.099|0.749|
70910023|NCT00577720|141308605|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRBB/35 mg IRBB)|1.132|||||TWO_SIDED|90.0|0.665|2.003||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||2.003|0.665|
70910024|NCT00577720|141308605|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/35 mg IRBB)|1.407|||||TWO_SIDED|90.0|0.913|2.404||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||2.404|0.913|
70910025|NCT00577720|141308605|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/35 mg DRFB)|1.165|||||TWO_SIDED|90.0|0.797|1.752||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||1.752|0.797|
70910026|NCT00577720|141308605|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/50 mg DRBB)|1.243|||||TWO_SIDED|90.0|0.828|1.99||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||1.990|0.828|
70910027|NCT00577720|141308606|SUPERIORITY_OR_OTHER||Ratio (LS Mean 35 mg DRFB/35 mg IRBB)|0.947|||||TWO_SIDED|90.0|0.316|2.993||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||2.993|0.316|
70910028|NCT00577720|141308606|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRBB/35 mg IRBB)|1.82|||||TWO_SIDED|90.0|0.929|5.429||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||5.429|0.929|
70910029|NCT00577720|141308606|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/35 mg IRBB)|1.58|||||TWO_SIDED|90.0|0.801|4.718||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||4.718|0.801|
70910030|NCT00577720|141308606|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/35 mg DRFB)|1.668|||||TWO_SIDED|90.0|0.856|4.668||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||4.668|0.856|
70910031|NCT00577720|141308606|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/50 mgDRBB)|0.868|||||TWO_SIDED|90.0|0.504|1.488||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||1.488|0.504|
70910032|NCT02531438|141308616|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|-1.6|||||TWO_SIDED|95.0|-7.1|3.8|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus moxifloxacin.|||3.8|-7.1|
70910033|NCT02531438|141308617|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|2.5|||||TWO_SIDED|95.0|-2.4|7.4|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus moxifloxacin.|||7.4|-2.4|
70910034|NCT02531438|141308618|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|2.5|||||TWO_SIDED|95.0|-1.7|6.8|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus moxifloxacin.|||6.8|-1.7|
70910035|NCT00162942|141308710|SUPERIORITY_OR_OTHER|||||||0.858|||||||Fisher Exact|||||||.858
70910036|NCT00162942|141308712|SUPERIORITY_OR_OTHER|||||||0.813||95.0|||||Student's t-test|||||||0.813
70910037|NCT00162942|141308713|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.000
70910038|NCT00162942|141308714|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||Student's t-test|||||||0.670
70910039|NCT00162942|141308715|SUPERIORITY_OR_OTHER|||||||0.977||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.977
70910040|NCT00162942|141308716|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.670
70910041|NCT00162942|141308717|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.170
70910042|NCT00162942|141308718|SUPERIORITY_OR_OTHER|||||||0.0773||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0773
70910043|NCT00162942|141308719|SUPERIORITY_OR_OTHER|||||||0.261||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.261
70910044|NCT00162942|141308720|SUPERIORITY_OR_OTHER|||||||0.379||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.379
70910045|NCT00162942|141308721|SUPERIORITY_OR_OTHER|||||||0.441||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.441
70910046|NCT00162942|141308722|SUPERIORITY_OR_OTHER|||||||0.759||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.759
70910047|NCT00162942|141308723|SUPERIORITY_OR_OTHER|||||||0.222||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.222
70910048|NCT00162942|141308724|SUPERIORITY_OR_OTHER|||||||0.256||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.256
70910049|NCT00162942|141308725|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.870
70910050|NCT00162942|141308726|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.350
70910051|NCT00162942|141308727|SUPERIORITY_OR_OTHER|||||||0.0632||95.0|||||Fisher Exact|||||||0.0632
70910052|NCT00162942|141308727|SUPERIORITY_OR_OTHER|||||||0.0504||95.0|||||Fisher Exact (Mid-P-Value)|||||||0.0504
70910053|NCT00162942|141308728|SUPERIORITY_OR_OTHER|||||||0.8265||95.0|||||Fisher Exact|||||||0.8265
70910054|NCT00162942|141308729|SUPERIORITY_OR_OTHER|||||||0.0676||95.0|||||Fisher Exact|||||||0.0676
70910055|NCT00162942|141308729|SUPERIORITY_OR_OTHER|||||||0.0506||95.0|||||Fisher Exact (Mid-P-Value)|||||||0.0506
70910056|NCT00162942|141308730|SUPERIORITY_OR_OTHER|||||||0.8721||95.0|||||Fisher Exact|||||||0.8721
71031265|NCT02087904|141570752|SUPERIORITY||LS Mean Difference|-9.2||||0.065|TWO_SIDED|95.0|-18.95|0.56||P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.56|-18.95|0.065
71031266|NCT02087904|141570752|SUPERIORITY||LS Mean Difference|-7.2||||0.145|TWO_SIDED|95.0|-16.84|2.49||P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||2.49|-16.84|0.145
70910057|NCT00162942|141308731|SUPERIORITY_OR_OTHER|||||||0.0289||95.0|||||Fisher Exact|||||||0.0289
70910058|NCT00162942|141308732|SUPERIORITY_OR_OTHER|||||||0.8618||95.0|||||Fisher Exact|||||||0.8618
70910059|NCT01253200|141308736|NON_INFERIORITY_OR_EQUIVALENCE|The Primary Safety Endpoint was evaluated using a one-sided, non-inferiority test for two binomial proportions at an alpha-level of 0.05. A 95% confidence interval based upon a score test of the difference of proportion of subjects in the Investigational and Control Groups free from a procedure-related complication seven days post-procedure was constructed. The upper bound of the confidence interval was compared to 10%.|Risk Difference (RD)|4.6|||||ONE_SIDED|95.0||9.78||||||Note that analysis of the primary outcome was conducted for Randomized subjects only as prespecified in the study protocol. This is consistent analysis publicly available in the Summary of Safety and Effectiveness Data (SSED).||9.78||
70910060|NCT03785340|141308748|SUPERIORITY|"The endpoints were tested in a fixed sequence, proceeding to the next endpoint until a p-value \>0.05 was found:~1. Change from baseline to 4 weeks (Day 28) in SANDE score~2. Change from baseline to 4 weeks (Day 28) in Lissamine Green conjunctival staining scores~3. Change from baseline to 2 weeks (Day 14) in SANDE score~4. Change from baseline to 2 weeks (Day 14) in Lissamine Green conjunctival staining scores"|Least squares mean difference|-0.844||||0.739|TWO_SIDED|95.0|-5.823|4.134|||Mixed Model Repeated Measures Analysis||Change from baseline to 4 weeks (Day 28) in SANDE score; OCU-310 vs. Placebo|Four endpoints (two primary and two secondary) were to be tested in a fixed sequence, proceeding to the next endpoint until a p-value \>0.05 was found. The analysis of the four outcomes employed a repeated measures mixed model with mean change from baseline score at the stated time point as the response with baseline score as a covariate and treatment, visit, and their interaction as fixed effects. The least squares mean difference (OCU 310 - placebo) at the stated time point was tested.||4.134|-5.823|0.739
70910061|NCT01253980|141308752|SUPERIORITY_OR_OTHER||Relative risk|0.6|||>|0.5|TWO_SIDED|95.0|0.11|3.37|||Fisher Exact|||||3.37|0.11|>0.50
70910062|NCT01700530|141308753|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
70910063|NCT04951479|141308795|SUPERIORITY|||||||0.00041|||||||t-test, 2 sided|||Paired t-test of KOOS Pain score pre and 6 months post embolization||||0.00041
70910064|NCT04951479|141308796|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||0.008
70910065|NCT04951479|141308797|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
70910066|NCT04951479|141308798|SUPERIORITY|||||||0.00797|||||||t-test, 2 sided|paired t-test||||||0.00797
70910067|NCT01682538|141308800|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the ratio was completely within the acceptance range (0.80-1.25)|Ratio of geometric means|0.858|||||TWO_SIDED|90.0|0.81|0.91|||ANOVA|||||0.91|0.81|
70910068|NCT01682538|141308801|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the ratio was completely within the acceptance range (0.80-1.25)|Ratio of geometric means|0.954|||||TWO_SIDED|90.0|0.85|1.07|||ANOVA|||||1.07|0.85|
70910069|NCT01682538|141308802|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence (no food effect) was established if the 90% confidence interval of the ratio was completely within the acceptance range (0.80 - 1.25).|Ratio of geometric means|1.013|||||TWO_SIDED|90.0|0.96|1.07|||ANOVA|||||1.07|0.96|
70910070|NCT01682538|141308803|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence (no food effect) was established if the 90% confidence interval of the ratio was completely within the acceptance range (0.80 - 1.25)|Ratio of geometric means|0.802|||||TWO_SIDED|90.0|0.71|0.9|||ANOVA|||||0.90|0.71|
70910071|NCT01268059|141308818|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.205||||0.027|TWO_SIDED|95.0|1.1|4.5|||Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by histology, disease stage, and ECOG performance status.|Hazard ratio and its 95 percent (%) confidence interval ( CIs) were calculated using the Cox proportional hazard model stratified by histology, disease stage, and Eastern Cooperative Oncology Group (ECOG) performance status.|||4.5|1.1|0.027
70910072|NCT01268059|141308820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.487||||||The 2-sided p-value was calculated by adjusting for the stratification factors histology, disease stage, and Eastern Cooperative Oncology Group (ECOG) performance status.|Cochran-Mantel-Haenszel|||Treatment effect Carboplatin/Paclitaxel + MEDI-575 versus Carboplatin/Paclitaxel.||||0.487
70910073|NCT01268059|141308820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.386||||||The 2-sided p-value was calculated by adjusting for the stratification factors histology, disease stage, and ECOG performance status.|Cochran-Mantel-Haenszel|||Treatment effect Carboplatin/Paclitaxel + MEDI-575 versus Carboplatin/Paclitaxel.||||0.386
71031267|NCT02087904|141570753|SUPERIORITY||LS Mean Difference|-3.2||||0.558|TWO_SIDED|95.0|-14.03|7.59||P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||7.59|-14.03|0.558
71031268|NCT02087904|141570753|SUPERIORITY||LS Mean Difference|-5.8||||0.295|TWO_SIDED|95.0|-16.77|5.11||P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||5.11|-16.77|0.295
71031269|NCT02087904|141570753|SUPERIORITY||LS Mean Difference|-6.8||||0.218|TWO_SIDED|95.0|-17.63|4.04||P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||4.04|-17.63|0.218
71031270|NCT02087904|141570754|SUPERIORITY||LS Mean Difference|-0.6||||0.664|TWO_SIDED|95.0|-3.58|2.28||P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||2.28|-3.58|0.664
71031271|NCT02087904|141570754|SUPERIORITY||LS Mean Difference|-2.7||||0.075|TWO_SIDED|95.0|-5.67|0.28||P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.28|-5.67|0.075
71031272|NCT02087904|141570754|SUPERIORITY||LS Mean Difference|-2.4||||0.107|TWO_SIDED|95.0|-5.33|0.52||P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.52|-5.33|0.107
71031273|NCT02087904|141570755|SUPERIORITY||LS Mean Difference|0.5||||0.5|TWO_SIDED|95.0|-4.26|2.08||P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||2.08|-4.26|0.5
71031274|NCT02087904|141570755|SUPERIORITY||LS Mean Difference|-2.2||||0.186|TWO_SIDED|95.0|-5.39|1.05||P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||1.05|-5.39|0.186
71031275|NCT02087904|141570755|SUPERIORITY||LS Mean Difference|-2.3||||0.157|TWO_SIDED|95.0|-5.46|0.88||P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.88|-5.46|0.157
70910074|NCT01268059|141308823|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|3.017|||||TWO_SIDED|95.0|1.2|7.4|||||The 95% confidence interval calculated using the Cox proportional hazard model stratified by histology, disease stage, and ECOG performance status.|||7.4|1.2|
71031276|NCT02087904|141570756|SUPERIORITY||LS Mean Difference|0.2||||0.319|TWO_SIDED|95.0|-0.23|0.69||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.69|-0.23|0.319
71031277|NCT02087904|141570756|SUPERIORITY||LS Mean Difference|-0.1||||0.564|TWO_SIDED|95.0|-0.6|0.33||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.33|-0.6|0.564
71031278|NCT02087904|141570756|SUPERIORITY||LS Mean Difference|0.0||||0.966|TWO_SIDED|95.0|-0.45|0.47||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.47|-0.45|0.966
71031279|NCT02087904|141570757|SUPERIORITY||LS Mean Difference|0.1||||0.602|TWO_SIDED|95.0|-0.41|0.7||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.7|-0.41|0.602
71031280|NCT02087904|141570757|SUPERIORITY||LS Mean Difference|0.0||||0.953|TWO_SIDED|95.0|-0.55|0.58||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.58|-0.55|0.953
71031281|NCT02087904|141570757|SUPERIORITY||LS Mean Difference|-0.1||||0.83|TWO_SIDED|95.0|-0.61|0.49||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.49|-0.61|0.83
71031282|NCT02087904|141570758|SUPERIORITY||LS Mean Difference|0.7||||0.804|TWO_SIDED|95.0|-4.91|6.33||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||6.33|-4.91|0.804
71031283|NCT02087904|141570758|SUPERIORITY||LS Mean Difference|-1.1||||0.699|TWO_SIDED|95.0|-6.9|4.63||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||4.63|-6.9|0.699
71031284|NCT02087904|141570758|SUPERIORITY||LS Mean Difference|1.4||||0.636|TWO_SIDED|95.0|-4.37|7.14||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||7.14|-4.37|0.636
71031285|NCT02087904|141570758|SUPERIORITY||LS Mean Difference|0.9||||0.756|TWO_SIDED|95.0|-4.91|6.76||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||6.76|-4.91|0.756
71031286|NCT02087904|141570758|SUPERIORITY||LS Mean Difference|-5.6||||0.068|TWO_SIDED|95.0|-11.55|0.42||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||0.42|-11.55|0.068
71031287|NCT02087904|141570758|SUPERIORITY||LS Mean Difference|-1.4||||0.649|TWO_SIDED|95.0|-7.34|4.58||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||4.58|-7.34|0.649
71031288|NCT02087904|141570759|SUPERIORITY||LS Mean Difference|-1.0||||0.75|TWO_SIDED|95.0|-7.14|5.14||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||5.14|-7.14|0.75
71031289|NCT02087904|141570759|SUPERIORITY||LS Mean Difference|-2.6||||0.409|TWO_SIDED|95.0|-8.82|3.6||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||3.6|-8.82|0.409
71031290|NCT02087904|141570759|SUPERIORITY||LS Mean Difference|-3.0||||0.338|TWO_SIDED|95.0|-9.24|3.18||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||3.18|-9.24|0.338
71031291|NCT02087904|141570759|SUPERIORITY||LS Mean Difference|0.7||||0.817|TWO_SIDED|95.0|-5.59|7.08||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||7.08|-5.59|0.817
71031292|NCT02087904|141570759|SUPERIORITY||LS Mean Difference|-2.0||||0.544|TWO_SIDED|95.0|-8.37|4.43||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||4.43|-8.37|0.544
71031293|NCT02087904|141570759|SUPERIORITY||LS Mean Difference|-2.5||||0.437|TWO_SIDED|95.0|-8.91|3.86||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||3.86|-8.91|0.437
71031294|NCT02087904|141570760|SUPERIORITY||LS Mean Difference|-2.2||||0.545|TWO_SIDED|95.0|-9.31|4.92||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||4.92|-9.31|0.545
71031295|NCT02087904|141570760|SUPERIORITY||LS Mean Difference|-0.4||||0.909|TWO_SIDED|95.0|-7.65|6.81||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||6.81|-7.65|0.909
71031296|NCT02087904|141570760|SUPERIORITY||LS Mean Difference|-4.0||||0.278|TWO_SIDED|95.0|-11.23|3.25||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||3.25|-11.23|0.278
71031297|NCT02087904|141570760|SUPERIORITY||LS Mean Difference|-1.2||||0.732|TWO_SIDED|95.0|-8.42|5.92||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||5.92|-8.42|0.732
71031298|NCT02087904|141570760|SUPERIORITY||LS Mean Difference|-4.6||||0.216|TWO_SIDED|95.0|-11.86|2.69||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||2.69|-11.86|0.216
71031299|NCT02087904|141570760|SUPERIORITY||LS Mean Difference|-9.2||||0.014|TWO_SIDED|95.0|-16.42|-1.88||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||-1.88|-16.42|0.014
71031300|NCT02087904|141570761|SUPERIORITY||LS Mean Difference|0.0||||0.874|TWO_SIDED|95.0|-0.56|0.66||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.66|-0.56|0.874
71031301|NCT02087904|141570761|SUPERIORITY||LS Mean Difference|-0.2||||0.451|TWO_SIDED|95.0|-0.86|0.38||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.38|-0.86|0.451
71031302|NCT02087904|141570761|SUPERIORITY||LS Mean Difference|0.3||||0.331|TWO_SIDED|95.0|-0.31|0.93||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.93|-0.31|0.331
71031303|NCT02087904|141570761|SUPERIORITY||LS Mean Difference|0.0||||0.932|TWO_SIDED|95.0|-0.73|0.67||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.67|-0.73|0.932
71031304|NCT02087904|141570761|SUPERIORITY||LS Mean Difference|-0.3||||0.344|TWO_SIDED|95.0|-1.07|0.37||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.37|-1.07|0.344
71031305|NCT02087904|141570761|SUPERIORITY||LS Mean Difference|0.3||||0.489|TWO_SIDED|95.0|-0.47|0.97||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.97|-0.47|0.489
71031306|NCT02087904|141570761|SUPERIORITY||LS Mean Difference|0.2||||0.498|TWO_SIDED|95.0|-0.42|0.85||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.85|-0.42|0.498
70910075|NCT01268059|141308823|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.134|||||TWO_SIDED|95.0|0.3|4.3|||||The 95% confidence interval calculated using the Cox proportional hazard model stratified by histology, disease stage, and ECOG performance status.|||4.3|0.3|
70910076|NCT01268059|141308824|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.315|||||TWO_SIDED|95.0|0.7|2.4|||||The 95% confidence interval calculated using the Cox proportional hazard model stratified by histology, disease stage, and ECOG performance status.|||2.4|0.7|
70910077|NCT01268059|141308824|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.083|||||TWO_SIDED|95.0|0.4|10.8|||||The 95% confidence interval calculated using the Cox proportional hazard model stratified by histology, disease stage, and ECOG performance status.|||10.8|0.4|
70910078|NCT02819479|141308837|OTHER||eta^2|0.37||||0.012|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(1,14) = 8.29||CHANGE IN VOLUME OF RADIATION NECROSIS: To explore durability of radiographic responses, we invoked a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn-Felt structure, and an unstructured covariance matrix (multivariate analysis of variance).||||0.012
70910079|NCT02819479|141308837|OTHER||eta^2|0.19||||0.09|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(1,14) = 3.29||CHANGE IN VOLUME OF CEREBRAL EDEMA: To explore durability of radiographic responses, we invoked a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn-Felt structure, and an unstructured covariance matrix (multivariate analysis of variance).||||0.09
70910080|NCT02819479|141308838|OTHER||eta^2|0.29||||0.02|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(5,34) = 2.74||To explore durability of clinical response, Migraine Disability Assessment (MIDAS) TOTAL SCORES were analyzed using a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn Felt structure, and an unstructured covariance matrix (multivariate analysis of variance)||||0.02
70910081|NCT02819479|141308839|OTHER||eta^2|0.37||||0.019|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(5,34) = 3.17||To explore durability of clinical response, Migraine Disability Assessment (MIDAS) DAYS OF HEADACHE were analyzed using a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn Felt structure, and an unstructured covariance matrix (multivariate analysis of variance).||||0.019
70910082|NCT02819479|141308840|OTHER||eta^2|0.3||||0.0006|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(5,35) = 3.96||To explore durability of clinical response, Migraine Disability Assessment (MIDAS) MIDAS PAIN LEVEL data were analyzed using a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn Felt structure, and an unstructured covariance matrix (multivariate analysis of variance).||||0.0006
70910083|NCT02819479|141308841|OTHER||eta^2|0.3||||0.02|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(5, 35) = 2.98||To explore durability of clinical response, Headache Impact Test (HIT-6™) scores were analyzed using a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn-Felt structure, and an unstructured covariance matrix (multivariate analysis of variance).||||0.02
70910084|NCT02819479|141308842|OTHER||eta^2|0.19||||0.23|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(2,14) = 1.62||To explore durability of clinical response, Karnofsky Performance Status Scale (KPS) data were analyzed using a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn-Felt structure, and an unstructured covariance matrix (multivariate analysis of variance).||||0.23
70910085|NCT02819479|141308843|OTHER||Pearson's r|-0.199||||0.374|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|Z = -0.889||Wilcoxon signed rank test (2-sided) was used to compare the total number of days on steroids in the 12 months prior versus the 12 months immediately following single dose IA Avastin (bevacizumab).||||0.374
70910086|NCT02819479|141308844|OTHER||partial eta^2|0.153||||0.66|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.451||DIGITS FORWARD: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the DIGITS FORWARD variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.660
70910087|NCT02819479|141308844|OTHER||partial eta^2|0.602||||0.1|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 3.78||DIGITS BACKWARD: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the DIGITS BACKWARD variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.100
70910088|NCT02819479|141308844|OTHER||partial eta^2|0.532||||0.149|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 2.847||NUMBERS \& LETTERS SPEED: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the NUMBERS \& LETTERS SPEED variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.149
70910089|NCT02819479|141308844|OTHER||partial eta^2|0.721||||0.041|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 6.470||NUMBERS \& LETTERS ERRORS: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the NUMBERS \& LETTERS ERRORS variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.041
71031307|NCT02087904|141570761|SUPERIORITY||LS Mean Difference|0.2||||0.637|TWO_SIDED|95.0|-0.8|0.49||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.49|-0.8|0.637
70910090|NCT02819479|141308844|OTHER||partial eta^2|0.566||||0.124|TWO_SIDED||||||One way Repeat Meas ANOVA|F (2,5) = 3.256||NUMBERS \& LETTERS EFFICIENCY: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the NUMBERS \& LETTERS EFFICIENCY variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.124
71031308|NCT02087904|141570761|SUPERIORITY||LS Mean Difference|0.3||||0.367|TWO_SIDED|95.0|-0.35|0.94||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.94|-0.35|0.367
71031309|NCT02087904|141570761|SUPERIORITY||LS Mean Difference|0.1||||0.67|TWO_SIDED|95.0|-0.51|0.79||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.79|-0.51|0.67
70910091|NCT02819479|141308844|OTHER||partial eta^2|0.042||||0.898|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.110||NAMING: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the NAMING variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.898
70910092|NCT02819479|141308844|OTHER||partial eta^2|0.107||||0.754|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.299||LIST LEARNING LIST IMMEDIATE RECALL: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the LIST LEARNING LIST IMMEDIATE RECALL variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.754
70910093|NCT02819479|141308844|OTHER||partial eta^2|0.751||||0.031|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 7.556||LIST LEARNING LIST LONG DELAYED RECALL: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the LIST LEARNING LIST LONG DELAYED RECALL variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.031
70910094|NCT02819479|141308844|OTHER||partial eta^2|0.289||||0.426|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 1.018||SHAPE LEARNING IMMEDIATE RECOGNITION: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the SHAPE LEARNING IMMEDIATE RECOGNITION variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.426
70910095|NCT02819479|141308844|OTHER||partial eta^2|0.361||||0.326|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 1.412||SHAPE LEARNING DELAYED RECOGNITION: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the SHAPE LEARNING DELAYED RECOGNITION variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.326
70910096|NCT02819479|141308844|OTHER||partial eta^2|0.09||||0.79|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.247||STORY LEARNING PHRASE UNIT IMMEDIATE RECALL: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the STORY LEARNING PHRASE UNIT IMMEDIATE RECALL variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.790
70910097|NCT02819479|141308844|OTHER||partial eta^2|0.239||||0.505|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.786||STORY LEARNING PHRASE UNIT DELAYED RECALL: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the STORY LEARNING PHRASE UNIT DELAYED RECALL variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.505
70910098|NCT02819479|141308844|OTHER||partial eta^2|0.636||||0.08|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 4.362||DESIGN CONSTRUCTION: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the DESIGN CONSTRUCTION variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.080
70910099|NCT02819479|141308844|OTHER||partial eta^2|0.693||||0.052|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 5.654||MAZES: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the MAZES variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.052
70910100|NCT02819479|141308844|OTHER||partial eta^2|0.013||||0.968|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.033||CATEGORIES: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the CATEGORIES variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.968
71031310|NCT02087904|141570761|SUPERIORITY||LS Mean Difference|-0.1||||0.776|TWO_SIDED|95.0|-0.76|0.57||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.57|-0.76|0.776
70910101|NCT02819479|141308844|OTHER||partial eta^2|0.261||||0.469|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.884||WORD GENERATION: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the WORD GENERATION variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.469
70910102|NCT05310084|141308853|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (coadministration group to separate-administration group) was greater than 0.67.|GMR|0.83|||||TWO_SIDED|95.0|0.77|0.89|||||GMRs and 95% CIs were calculated by exponentiating LSmeans difference of logarithms of concentrations (coadmin group-separate admin group), corresponding CIs based on analysis of log transformed assay results using a linear regression model.|||0.89|0.77|
71031311|NCT02087904|141570761|SUPERIORITY||LS Mean Difference|0.3||||0.387|TWO_SIDED|95.0|-0.37|0.96||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.96|-0.37|0.387
71031312|NCT02087904|141570762|SUPERIORITY||LS Mean Difference|-0.2||||0.661|TWO_SIDED|95.0|-0.86|0.54||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.54|-0.86|0.661
71031313|NCT02087904|141570762|SUPERIORITY||LS Mean Difference|-0.6||||0.122|TWO_SIDED|95.0|-1.26|0.15||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.15|-1.26|0.122
71031314|NCT02087904|141570762|SUPERIORITY||LS Mean Difference|-0.2||||0.507|TWO_SIDED|95.0|-0.94|0.47||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.47|-0.94|0.507
71031315|NCT02087904|141570762|SUPERIORITY||LS Mean Difference|-0.1||||0.892|TWO_SIDED|95.0|-0.85|0.74||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.74|-0.85|0.892
71031316|NCT02087904|141570762|SUPERIORITY||LS Mean Difference|-0.3||||0.433|TWO_SIDED|95.0|-1.12|0.48||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.48|-1.12|0.433
71031317|NCT02087904|141570762|SUPERIORITY||LS Mean Difference|0.0||||0.92|TWO_SIDED|95.0|-0.84|0.76||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.76|-0.84|0.92
71031318|NCT02087904|141570762|SUPERIORITY||LS Mean Difference|0.0||||0.957|TWO_SIDED|95.0|-0.68|0.71||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.71|-0.68|0.957
71031319|NCT02087904|141570762|SUPERIORITY||LS Mean Difference|-0.4||||0.222|TWO_SIDED|95.0|-1.13|0.26||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.26|-1.13|0.222
71031320|NCT02087904|141570762|SUPERIORITY||LS Mean Difference|-0.4||||0.209|TWO_SIDED|95.0|-1.15|0.25||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.25|-1.15|0.209
71031321|NCT02087904|141570762|SUPERIORITY||LS Mean Difference|0.1||||0.813|TWO_SIDED|95.0|-0.62|0.79||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.79|-0.62|0.813
71031322|NCT02087904|141570762|SUPERIORITY||LS Mean Difference|-0.5||||0.135|TWO_SIDED|95.0|-1.25|0.17||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.17|-1.25|0.135
71031323|NCT02087904|141570762|SUPERIORITY||LS Mean Difference|-0.1||||0.679|TWO_SIDED|95.0|-0.85|0.57||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.57|-0.85|0.679
71031324|NCT02087904|141570763|SUPERIORITY||LS Mean Difference|0.0||||0.978|TWO_SIDED|95.0|-0.76|0.79||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.79|-0.76|0.978
71031325|NCT02087904|141570763|SUPERIORITY||LS Mean Difference|0.0||||0.925|TWO_SIDED|95.0|-0.75|0.82||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.82|-0.75|0.925
71031326|NCT02087904|141570763|SUPERIORITY||LS Mean Difference|-0.2||||0.659|TWO_SIDED|95.0|-0.96|0.61||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.61|-0.96|0.659
71031327|NCT02087904|141570763|SUPERIORITY||LS Mean Difference|-0.2||||0.633|TWO_SIDED|95.0|-1.1|0.67||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.67|-1.1|0.633
71031328|NCT02087904|141570763|SUPERIORITY||LS Mean Difference|-0.3||||0.46|TWO_SIDED|95.0|-1.23|0.56||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.56|-1.23|0.46
71031329|NCT02087904|141570763|SUPERIORITY||LS Mean Difference|-0.2||||0.663|TWO_SIDED|95.0|-1.1|0.7||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.7|-1.1|0.663
71031330|NCT02087904|141570763|SUPERIORITY||LS Mean Difference|-0.1||||0.696|TWO_SIDED|95.0|-0.89|0.59||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.59|-0.89|0.696
71031331|NCT02087904|141570763|SUPERIORITY||LS Mean Difference|-0.4||||0.278|TWO_SIDED|95.0|-1.16|0.34||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.34|-1.16|0.278
71031332|NCT02087904|141570763|SUPERIORITY||LS Mean Difference|-0.4||||0.357|TWO_SIDED|95.0|-1.1|0.4||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.4|-1.1|0.357
71031333|NCT02087904|141570763|SUPERIORITY||LS Mean Difference|-0.1||||0.761|TWO_SIDED|95.0|-0.87|0.64||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.64|-0.87|0.761
71031334|NCT02087904|141570763|SUPERIORITY||LS Mean Difference|-0.5||||0.218|TWO_SIDED|95.0|-1.02|0.51||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.51|-1.02|0.218
71031335|NCT02087904|141570763|SUPERIORITY||LS Mean Difference|-0.3||||0.513|TWO_SIDED|95.0|-1.02|0.51||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.51|-1.02|0.513
71031336|NCT02087904|141570764|SUPERIORITY||LS Mean Difference|0.1||||0.728|TWO_SIDED|95.0|-0.52|0.75||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.75|-0.52|0.728
71031337|NCT02087904|141570764|SUPERIORITY||LS Mean Difference|-0.4||||0.219|TWO_SIDED|95.0|-1.06|0.24||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.24|-1.06|0.219
71031338|NCT02087904|141570764|SUPERIORITY||LS Mean Difference|-0.1||||0.673|TWO_SIDED|95.0|-0.79|0.51||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.51|-0.79|0.673
71031339|NCT02087904|141570765|SUPERIORITY||LS Mean Difference|0.0||||0.984|TWO_SIDED|95.0|-0.73|0.71||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.71|-0.73|0.984
71031340|NCT02087904|141570765|SUPERIORITY||LS Mean Difference|-0.5||||0.145|TWO_SIDED|95.0|-1.26|0.19||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.19|-1.26|0.145
71031341|NCT02087904|141570765|SUPERIORITY||LS Mean Difference|-0.2||||0.527|TWO_SIDED|95.0|-0.96|0.49||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.49|-0.96|0.527
71031342|NCT02087904|141570766|SUPERIORITY||LS Mean Difference|0.1||||0.836|TWO_SIDED|95.0|-0.71|0.87||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.87|-0.71|0.836
71031343|NCT02087904|141570766|SUPERIORITY||LS Mean Difference|-0.1||||0.738|TWO_SIDED|95.0|-0.94|0.66||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.66|-0.94|0.738
71031344|NCT02087904|141570766|SUPERIORITY||LS Mean Difference|-0.4||||0.3|TWO_SIDED|95.0|-1.22|0.38||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.38|-1.22|0.3
71031345|NCT02087904|141570767|SUPERIORITY||LS Mean Difference|0.5||||0.992|TWO_SIDED|95.0|-101.59|102.62||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||102.62|-101.59|0.992
71031346|NCT02087904|141570767|SUPERIORITY||LS Mean Difference|3.6||||0.948|TWO_SIDED|95.0|-103.95|111.1||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||111.10|-103.95|0.948
71031347|NCT02087904|141570767|SUPERIORITY||LS Mean Difference|-33.1||||0.523|TWO_SIDED|95.0|-134.76|68.65||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||68.65|-134.76|0.523
71031348|NCT02087904|141570767|SUPERIORITY||LS Mean Difference|4.2||||0.799|TWO_SIDED|95.0|-28.47|36.95||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||36.95|-28.47|0.799
71031349|NCT02087904|141570767|SUPERIORITY||LS Mean Difference|9.0||||0.609|TWO_SIDED|95.0|-25.62|43.64||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||43.64|-25.62|0.609
71031350|NCT02087904|141570767|SUPERIORITY||LS Mean Difference|1.6||||0.923|TWO_SIDED|95.0|-30.97|34.19||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||34.19|-30.97|0.923
70910103|NCT05310084|141308854|NON_INFERIORITY|Noninferiority was declared for an influenza strain if the lower bound of the 2-sided 95% CI for the GMR (coadministration group to separate administration group) was greater than 0.67|Geometric Mean Ratio|0.89|||||TWO_SIDED|95.0|0.77|1.04|||||GMRs and 95% CIs were calculated by exponentiating LSmeans difference of logarithms of titers (coadministration group-separate administration group), corresponding CIs based on analysis of log transformed assay results using a linear regression model|B/Austria||1.04|0.77|
70910104|NCT05310084|141308854|NON_INFERIORITY|Noninferiority was declared for an influenza strain if the lower bound of the 2-sided 95% CI for the GMR (coadministration group to separate administration group) was greater than 0.67.|GMR|1.0|||||TWO_SIDED|95.0|0.89|1.13|||||GMRs and 95% CIs were calculated by exponentiating LSmeans difference of logarithms of titers (coadministration group-separate administration group), corresponding CIs based on analysis of log transformed assay results using a linear regression model|B/Phuket||1.13|0.89|
70910105|NCT05310084|141308854|NON_INFERIORITY|Noninferiority was declared for an influenza strain if the lower bound of the 2-sided 95% CI for the GMR (coadministration group to separate administration group) was greater than 0.67.|GMR|0.95|||||TWO_SIDED|95.0|0.83|1.09|||||GMRs and 95% CIs were calculated by exponentiating LSmeans difference of logarithms of titers (coadministration group-separate administration group), corresponding CIs based on analysis of log transformed assay results using a linear regression model|H1N1 A/Victoria||1.09|0.83|
70910106|NCT05310084|141308854|NON_INFERIORITY|Noninferiority was declared for an influenza strain if the lower bound of the 2-sided 95% CI for the GMR (coadministration group to separate administration group) was greater than 0.67.|GMR|0.96|||||TWO_SIDED|95.0|0.85|1.09|||||GMRs and 95% CIs were calculated by exponentiating LSmeans difference of logarithms of titers (coadministration group-separate administration group), corresponding CIs based on analysis of log transformed assay results using a linear regression model|H3N2 A/Darwin||1.09|0.85|
70910107|NCT02941146|141308861|OTHER||sucess proportion|64.3|||||TWO_SIDED|95.0|35.1|87.2||||||||87.2|35.1|
70910108|NCT04731714|141308895|SUPERIORITY|||||||0.0104|||||||Mixed Models Analysis|See publication for details||||||0.0104
71031351|NCT02087904|141570767|SUPERIORITY||LS Mean Difference|2.1||||0.937|TWO_SIDED|95.0|-49.88|54.08||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||54.08|-49.88|0.937
71031352|NCT02087904|141570767|SUPERIORITY||LS Mean Difference|4.1||||0.882|TWO_SIDED|95.0|-50.68|58.95||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||58.95|-50.68|0.882
71031353|NCT02087904|141570767|SUPERIORITY||LS Mean Difference|13.8||||0.602|TWO_SIDED|95.0|-38.05|65.55||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||65.55|-38.05|0.602
71031354|NCT02087904|141570768|SUPERIORITY||LS Mean Difference|-41.7||||0.554|TWO_SIDED|95.0|-180.49|97.04||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||97.04|-180.49|0.554
71031355|NCT02087904|141570768|SUPERIORITY||LS Mean Difference|2.7||||0.97|TWO_SIDED|95.0|-140.86|146.31||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||146.31|-140.86|0.97
71031356|NCT02087904|141570768|SUPERIORITY||LS Mean Difference|-26.1||||0.713|TWO_SIDED|95.0|-165.47|113.32||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||113.32|-165.47|0.713
71031357|NCT02087904|141570768|SUPERIORITY||LS Mean Difference|-25.1||||0.272|TWO_SIDED|95.0|-70.12|19.88||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||19.88|-70.12|0.272
70910109|NCT04731714|141308896|SUPERIORITY|||||||0.079|||||||Mixed Models Analysis|See publication for details||||||0.079
70910110|NCT04731714|141308897|SUPERIORITY|||||||0.9222|||||||Mixed Models Analysis|See publication for details||||||0.9222
70910111|NCT04731714|141308898|SUPERIORITY|||||||0.7995|||||||Mixed Models Analysis|See publication for details||||||0.7995
70910112|NCT04731714|141308899|OTHER|||||||0.314||||||rhythmic days|Friedman Test|See publication for further details||||||0.3140
70910113|NCT04731714|141308899|OTHER|||||||0.239||||||arrhythmic days|Friedman Test|See publication for further details||||||0.239
70910114|NCT04731714|141308903|SUPERIORITY|||||||0.8844|||||||Mixed Models Analysis|See publication for details||||||0.8844
70910115|NCT04731714|141308905|OTHER|||||||0.73|||||||binomial|One-sided||||||0.73
70910116|NCT03019458|141308936|SUPERIORITY|||||||0.084||||||The p value was not adjusted for multiple comparisons but rather it is the priori threshold for statistical significance at p\<0.05.|Mixed Models Analysis|We adjusted for baseline Eating Assessment Tool-10 (EAT-10), MGH-Swallowing Screening Test (MGH-SST), and the Burkes-Fahn-Marsden Dysonia Scale (BFM).||||||0.084
70910117|NCT01561079|141308970|SUPERIORITY_OR_OTHER|||||||0.001||||||The p values were not adjusted for multiplicity The a priori threshold = .05|Hierarchical Linear Modeling|The p-value was calculated||||||0.001
70910118|NCT01561079|141308971|SUPERIORITY_OR_OTHER||||||<|0.002|||||||Hierarchical Linear Modeling|||||||<.002
70910119|NCT01561079|141308972|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Hierarchical Linear Modeling|||||||0.0001
71092012|NCT04154956|141690613|SUPERIORITY||Odds Ratio (OR)|0.88||||0.6972|TWO_SIDED|95.0|0.55|1.42||P-value is provided for information only, there is no statistical inference based on this P-value.|Cochran-Mantel-Haenszel||Odds ratio and its 2-sided CI were provided from a Cochran-Mantel-Haenszel (CMH) test stratified according to the stratification factors.|||1.42|0.55|0.6972
71092013|NCT04154956|141690614|SUPERIORITY||Hazard Ratio (HR)|0.729||||0.0157|TWO_SIDED|95.0|0.546|0.972||P-value is provided for information only, there is no statistical inference based on this P-value.|Log Rank||Hazard ratio and CIs were computed from a stratified Cox model according to stratification factors as per IRT.|||0.972|0.546|0.0157
70910120|NCT01561079|141308973|SUPERIORITY_OR_OTHER|||||||0.008|||||||Hierarchical Linear Modeling|The reported p-value was calculated||||||.008
70910121|NCT01561079|141308974|SUPERIORITY_OR_OTHER|||||||0.002|||||||Hierarchical Linear Modeling|||||||.002
70910122|NCT00367237|141308997|SUPERIORITY_OR_OTHER||Difference in percentages of respondents|19.61||||0.021||95.0|3.27|35.95||Comparison of treatments (IFX + MTX versus MTX)|Chi-squared||Difference in percentages of respondents is (percentage of respondents in IFX+MTX group minus percentage of respondents in MTX group)|||35.95|3.27|0.0210
70910123|NCT00367237|141308997|SUPERIORITY_OR_OTHER||Proportion of Responders|0.863||||||95.0||||||||||||
70910124|NCT00367237|141308997|SUPERIORITY_OR_OTHER||Proportion of Responders|0.667||||||95.0||||||||||||
70910125|NCT05677867|141309026|OTHER||Ratio of Adjusted Geometric Means|97.4|||||TWO_SIDED|90.0|92.92|102.08|||||The ratios (and 90% CIs) are expressed as percentages.|Natural log transformed AUCinf was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect. The adjusted mean differences and 90% Confidence Intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios. Formulation A was the Reference treatment while Formulation B was the Test treatment.||102.08|92.92|
70910126|NCT05677867|141309027|OTHER||Ratio of Geometric Adjusted Means|97.36|||||TWO_SIDED|90.0|92.77|102.17|||||The ratios (and 90% CIs) are expressed as percentages.|Natural log transformed AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios. Formulation A was the Reference treatment while Formulation B was the Test treatment.||102.17|92.77|
70970488|NCT02706873|141446966|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|32.8|||<|0.001|TWO_SIDED|95.0|25.4|40.2||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||40.2|25.4|<0.001
71092014|NCT04154956|141690615|SUPERIORITY||Hazard Ratio (HR)|0.544||||0.0002|TWO_SIDED|95.0|0.388|0.763||P-value is provided for information only, there is no statistical inference based on this P-value.|Log Rank||Hazard ratio and CIs were computed from a stratified Cox model according to stratification factors as per IRT.|||0.763|0.388|0.0002
70910127|NCT05677867|141309028|OTHER||Ratio of Adjusted Means|94.7|||||TWO_SIDED|90.0|81.4|110.18|||||The ratios (and 90% CIs) are expressed as percentages.|Natural log transformed Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios. Formulation A was the Reference treatment while Formulation B was the Test treatment.||110.18|81.40|
70910128|NCT00839982|141309033|SUPERIORITY|||||||0.03||||||Hypothesis: achieving CR provides an overall longer survival.|Chi-squared|||||||0.03
70910129|NCT01341080|141309041|OTHER||Cohen's d|0.15||||0.05|TWO_SIDED|95.0|-4.01|4.61|||Repeated measures analysis or variance|||Efficacy was measured as a change on the Berg Balance Scale (BBS) from baseline to the end of study after 8 weeks on drug. The BBS has a scale range of 0-56, with 56 indicating normal balance. To evaluate efficacy, repeated measures analysis of variance was run on BBS scores. The scale score was the dependent measure, time point (baseline or end of study) was the repeat measure, and treatment group (varenicline or sugar pill) was the independent measure. Significance was defined as alpha \<0.05.||4.61|-4.01|0.05
70910130|NCT01341080|141309042|OTHER||Cohen's d|0.16||||0.05|TWO_SIDED|95.0|-1.39|1.53|||Repeated measures analysis or variance|||Change in cognitive functioning was measured in part with the Frontal Assessment Battery (FAB) from Baseline to 8 weeks on drug. Repeated analysis of variance was run on the FAB scores. Scale cores was the dependent measure, time point (Baseline or end of study) was the repeated measure, and treatment group (varenicline or sugar pill) was the independent measure. Significant was defined as \<0.05.||1.53|-1.39|0.05
70910131|NCT01341080|141309043|OTHER||Cohen's d|0.81||||0.05|TWO_SIDED|95.0|-0.4|1.4|||Repeated measures analysis or variance|||Change in cognitive functioning was measured in part with the Mini Mental State Exam (MMSE) from Baseline to 8 weeks on drug. Repeated analysis of variance was run on the MMSE scores. Scale score was the dependent measure, time point (Baseline or end of study) was the repeated measure, and treatment group (varenicline or sugar pill) was the independent measure. Significant was defined as \<0.05.||1.40|-0.40|0.05
70910132|NCT03248440|141309066|SUPERIORITY|||||||0.579|||||||2-sided Pearson's chi-square|||||||0.579
70910133|NCT03248440|141309067|SUPERIORITY|||||||0.082|||||||2-sided Pearson's chi-square|||||||0.082
70910134|NCT01052662|141309068|SUPERIORITY_OR_OTHER||Slope|-0.00935|STANDARD_ERROR_OF_MEAN|0.00356|=|0.00874|TWO_SIDED||||||Mixed Models Analysis||Z = -2.62209|We modeled the mean proportion of weekly opioid use using a mixed-effect linear regression approach to assess the treatment effect, the time effect and the interaction of time x treatment effect while adjusting for the baseline mean proportion of weekly opioid use with baseline COWS, Addiction Severity Index (ASI) psychiatric and legal composite scores as covariates.||||=0.00874
70910135|NCT01052662|141309069|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.87||||0.64|TWO_SIDED||||||Log Rank|||||||0.64
70910136|NCT01052662|141309070|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|2.4||||1.2|TWO_SIDED|||||These results are using survival curve estimates to first positive urine toxicology for any opioid. The last observation carried forward (LOCF) was used to perform our survival event analyses.|Log Rank|||||||1.2
70970489|NCT02706873|141446967|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|3.72|||<|0.001|TWO_SIDED|95.0|2.42|5.03||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||5.03|2.42|<0.001
71031358|NCT02087904|141570768|SUPERIORITY||LS Mean Difference|11.1||||0.64|TWO_SIDED|95.0|-35.63|57.8||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||57.8|-35.63|0.64
71031359|NCT02087904|141570768|SUPERIORITY||LS Mean Difference|-11.8||||0.608|TWO_SIDED|95.0|-56.94|33.38||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||33.38|-56.94|0.608
71031360|NCT02087904|141570768|SUPERIORITY||LS Mean Difference|-40.3||||0.319|TWO_SIDED|95.0|-119.88|39.3||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||39.3|-119.88|0.319
71031361|NCT02087904|141570768|SUPERIORITY||LS Mean Difference|24.4||||0.56|TWO_SIDED|95.0|-58.05|106.91||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||106.91|-58.05|0.56
71031362|NCT02087904|141570768|SUPERIORITY||LS Mean Difference|-28.1||||0.489|TWO_SIDED|95.0|-107.97|51.82||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||51.82|-107.97|0.489
71031363|NCT02087904|141570769|SUPERIORITY||LS Mean Difference|0.0||||0.972|TWO_SIDED|95.0|-0.015|0.015||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||0.015|-0.015|0.972
71031364|NCT02087904|141570769|SUPERIORITY||LS Mean Difference|-0.001||||0.929|TWO_SIDED|95.0|-0.017|0.015||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||0.015|-0.017|0.929
71031365|NCT02087904|141570769|SUPERIORITY||LS Mean Difference|-0.005||||0.543|TWO_SIDED|95.0|-0.02|0.01||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||0.01|-0.02|0.543
71031366|NCT02087904|141570769|SUPERIORITY||LS Mean Difference|0.008||||0.752|TWO_SIDED|95.0|-0.043|0.059||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||0.059|-0.043|0.752
71031367|NCT02087904|141570769|SUPERIORITY||LS Mean Difference|0.011||||0.691|TWO_SIDED|95.0|-0.042|0.064||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||0.064|-0.042|0.691
71031368|NCT02087904|141570769|SUPERIORITY||LS Mean Difference|0.01||||0.71|TWO_SIDED|95.0|-0.041|0.06||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||0.06|-0.041|0.71
71031369|NCT02087904|141570769|SUPERIORITY||LS Mean Difference|0.0||||0.965|TWO_SIDED|95.0|-0.019|0.02||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||0.02|-0.019|0.965
71031370|NCT02087904|141570769|SUPERIORITY||LS Mean Difference|-0.002||||0.885|TWO_SIDED|95.0|-0.022|0.019||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||0.019|-0.022|0.885
71031371|NCT02087904|141570769|SUPERIORITY||LS Mean Difference|0.001||||0.887|TWO_SIDED|95.0|-0.018|0.021||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||0.021|-0.018|0.887
71031372|NCT02087904|141570770|SUPERIORITY||LS Mean Difference|-0.005||||0.619|TWO_SIDED|95.0|-0.024|0.014||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||0.014|-0.024|0.619
71031373|NCT02087904|141570770|SUPERIORITY||LS Mean Difference|-0.001||||0.952|TWO_SIDED|95.0|-0.02|0.019||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||0.019|-0.02|0.952
70970490|NCT02706873|141446967|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|4.42|||<|0.001|TWO_SIDED|95.0|3.12|5.72||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||5.72|3.12|<0.001
71031374|NCT02087904|141570770|SUPERIORITY||LS Mean Difference|-0.003||||0.765|TWO_SIDED|95.0|-0.022|0.016||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||0.016|-0.022|0.765
71031375|NCT02087904|141570770|SUPERIORITY||LS Mean Difference|-0.04||||0.258|TWO_SIDED|95.0|-0.11|0.03||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||0.03|-0.11|0.258
70910137|NCT00087490|141309098|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the Food and Drug Administration (FDA) suggested boundary of delta= -0.10.|Percent Difference|4.2||||0.249|TWO_SIDED|95.0|-3.0|11.5|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95 percent (%) confidence interval (CI).||11.5|-3.0|0.249
70910138|NCT00087490|141309099|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|3.9||||0.168|TWO_SIDED|95.0|-1.7|9.5|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||9.5|-1.7|0.168
70910139|NCT00087490|141309100|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|7.1||||0.048|TWO_SIDED|95.0|0.1|14.2|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||14.2|0.1|0.048
70910140|NCT00087490|141309101|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|4.8||||0.09|TWO_SIDED|95.0|-0.7|10.3|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||10.3|-0.7|0.090
70910141|NCT00087490|141309102|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|6.6||||0.127|TWO_SIDED|95.0|-1.9|15.0|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||15.0|-1.9|0.127
70910142|NCT00087490|141309103|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|16.6||||0|TWO_SIDED|95.0|9.0|24.2|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||24.2|9.0|0.000
70910143|NCT00087490|141309104|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|7.7||||0.051|TWO_SIDED|95.0|0.0|15.4|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||15.4|-0.0|0.051
70910144|NCT00087490|141309105|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|15.0||||0|TWO_SIDED|95.0|8.2|21.8|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||21.8|8.2|0.000
70970491|NCT02706873|141446968|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|9.8||||0.002|TWO_SIDED|95.0|3.5|16.2||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||16.2|3.5|0.002
70910145|NCT00087490|141309108|SUPERIORITY_OR_OTHER|||||||0.022|TWO_SIDED|||||Alpha = 0.05 was the level of significance if the null hypothesis was rejected.|Wilcoxon (Mann-Whitney)|||Null hypothesis was that there was no difference in the length of hospital stay between the treatment groups.||||0.022
70910146|NCT00087490|141309109|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED|||||Alpha = 0.05 was the level of significance if the null hypothesis was rejected.|Wilcoxon (Mann-Whitney)|||Null hypothesis was that there was no difference in the length of hospital stay between the treatment groups.||||0.016
70910147|NCT00087490|141309110|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||t-test, 2 sided|||||||0.000
70910148|NCT00087490|141309111|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||t-test, 2 sided|||||||0.000
70910149|NCT02300311|141309119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.849|STANDARD_ERROR_OF_MEAN|0.306|<|0.0001|TWO_SIDED|95.0|-2.454|-1.244||The model included the fixed, categorical effects of treatment, country, time and treatment-by-time interaction and the continuous covariate of baseline PI.|REML based repeated measures approach|restricted maximum likelihood (REML) based repeated measures approach|Differences between the treatment group effects (Finalgon® cream - placebo).|"PID8 utilised a restricted maximum likelihood (REML) based repeated measures approach, using all available longitudinal pain intensity observations at each post-baseline time up to 8 hours.~The statistical model was applied to the analysis of change from baseline in pain intensity at 0.5, 1, 2, 3, 4, 6 and 8 hours."||-1.244|-2.454|<0.0001
70910150|NCT02300311|141309120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.341|STANDARD_ERROR_OF_MEAN|0.248|<|0.0001|TWO_SIDED|95.0|-1.832|-0.851||The statistical model included the fixed, categorical effects of treatment, country, time and treatment-by-time interaction and the continuous covariate of baseline PI.|REML based repeated measures approach|restricted maximum likelihood (REML) based repeated measures approach|Differences between the treatment group effects (Finalgon® cream - placebo)|"PID4 utilised a restricted maximum likelihood (REML) based repeated measures approach, using all available longitudinal pain intensity observations at each post-baseline time up to 4 hours.~The statistical model was applied to the analysis of change from baseline in pain intensity at 0.5, 1, 2, 3, and 4 hours."||-0.851|-1.832|<0.0001
71031376|NCT02087904|141570770|SUPERIORITY||LS Mean Difference|0.023||||0.535|TWO_SIDED|95.0|-0.049|0.094||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||0.094|-0.049|0.535
71031377|NCT02087904|141570770|SUPERIORITY||LS Mean Difference|-0.006||||0.866|TWO_SIDED|95.0|-0.076|0.064||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||0.064|-0.076|0.866
71031378|NCT02087904|141570770|SUPERIORITY||LS Mean Difference|-0.012||||0.413|TWO_SIDED|95.0|-0.041|0.017||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||0.017|-0.041|0.413
71031379|NCT02087904|141570770|SUPERIORITY||LS Mean Difference|0.012||||0.445|TWO_SIDED|95.0|-0.018|0.042||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||0.042|-0.018|0.445
71031380|NCT02087904|141570770|SUPERIORITY||LS Mean Difference|-0.003||||0.835|TWO_SIDED|95.0|-0.032|0.026||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||0.026|-0.032|0.835
71031381|NCT02087904|141570771|SUPERIORITY||Response Rate Difference|7.0||||0.311|TWO_SIDED|95.0|-7.3|21.4||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||21.4|-7.3|0.311
71031382|NCT02087904|141570771|SUPERIORITY||Response Rate Difference|5.5||||0.435|TWO_SIDED|95.0|-8.9|19.9||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||19.9|-8.9|0.435
71031383|NCT02087904|141570771|SUPERIORITY||Response Rate Difference|5.5||||0.435|TWO_SIDED|95.0|-8.9|19.9||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||19.9|-8.9|0.435
71031384|NCT02087904|141570772|SUPERIORITY||Response Rate Difference|2.4||||0.744|TWO_SIDED|95.0|-11.9|16.8||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||16.8|-11.9|0.744
71031385|NCT02087904|141570772|SUPERIORITY||Response Rate Difference|4.3||||0.581|TWO_SIDED|95.0|-10.1|18.7||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||18.7|-10.1|0.581
71031386|NCT02087904|141570772|SUPERIORITY||Response Rate Difference|10.4||||0.146|TWO_SIDED|95.0|-3.5|24.3||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||24.3|-3.5|0.146
71031387|NCT02087904|141570773|SUPERIORITY||Response Rate Difference|-1.3||||0.824|TWO_SIDED|95.0|-14.9|12.4||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||12.4|-14.9|0.824
71031388|NCT02087904|141570773|SUPERIORITY||Response Rate Difference|0.8||||0.964|TWO_SIDED|95.0|-12.8|14.5||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||14.5|-12.8|0.964
71031389|NCT02087904|141570773|SUPERIORITY||Response Rate Difference|2.1||||0.763|TWO_SIDED|95.0|-11.3|15.6||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||15.6|-11.3|0.763
71031390|NCT01389102|141570780|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71031391|NCT01389102|141570780|SUPERIORITY_OR_OTHER|||||||0.0099||95.0|||||ANCOVA|||||||0.0099
71031392|NCT01389102|141570780|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||ANCOVA|||||||0.0004
71031393|NCT01389102|141570781|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71031394|NCT01389102|141570781|SUPERIORITY_OR_OTHER|||||||0.0406||95.0|||||ANCOVA|||||||0.0406
71031395|NCT01389102|141570781|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71031396|NCT00624065|141570827|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.968||||0.8822||95.0|0.63|1.49|||Regression, Logistic|||||1.49|0.63|0.8822
71031397|NCT00696020|141570829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.027||0.3791|TWO_SIDED|95.0|-0.029|0.076||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.076|-0.029|0.3791
71031398|NCT00696020|141570829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.027||0.2133|TWO_SIDED|95.0|-0.019|0.085||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.085|-0.019|0.2133
71031399|NCT00696020|141570829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.027||0.0337|TWO_SIDED|95.0|0.004|0.11||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.110|0.004|0.0337
71031400|NCT00696020|141570830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.026||0.1163|TWO_SIDED|95.0|-0.01|0.093||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.093|-0.010|0.1163
71031401|NCT00696020|141570830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.026||0.0224|TWO_SIDED|95.0|0.009|0.111||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.111|0.009|0.0224
71031402|NCT00696020|141570830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.055|STANDARD_ERROR_OF_MEAN|0.026||0.038|TWO_SIDED|95.0|0.003|0.107||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.107|0.003|0.0380
71031403|NCT00696020|141570831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.047||0.9573|TWO_SIDED|95.0|-0.089|0.094|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.094|-0.089|0.9573
71031404|NCT00696020|141570831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.046||0.0321|TWO_SIDED|95.0|0.009|0.189|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.189|0.009|0.0321
71031405|NCT00696020|141570831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.047||0.0125|TWO_SIDED|95.0|0.025|0.209|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.209|0.025|0.0125
71031406|NCT00696020|141570832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.03||0.0052|TWO_SIDED|95.0|0.026|0.145|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.145|0.026|0.0052
71031407|NCT00696020|141570832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.03||0.0086|TWO_SIDED|95.0|0.02|0.138|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.138|0.020|0.0086
71031408|NCT00696020|141570832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.066|0.185|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.185|0.066|<0.0001
71031409|NCT00696020|141570833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.116|STANDARD_ERROR_OF_MEAN|0.056||0.0384|TWO_SIDED|95.0|0.006|0.225|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.225|0.006|0.0384
71031410|NCT00696020|141570833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|STANDARD_ERROR_OF_MEAN|0.055||0.0009|TWO_SIDED|95.0|0.076|0.292|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.292|0.076|0.0009
71031411|NCT00696020|141570833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.239|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|0.13|0.349|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.349|0.130|<0.0001
70910151|NCT02300311|141309121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.958|STANDARD_ERROR_OF_MEAN|0.381|<|0.0001|TWO_SIDED|95.0|-3.712|-2.205|||ANCOVA|ANCOVA using the fixed, categorical effects of treatment and country as well as the continuous covariate of baseline PI.|Differences between the treatment group effects (Finalgon® cream - placebo)|The difference of average pain intensity from pre-dose baseline on the last individual treatment day was analysed using ANCOVA.||-2.205|-3.712|<0.0001
71031412|NCT00696020|141570834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.357|STANDARD_ERROR_OF_MEAN|6.76||0.001|TWO_SIDED|95.0|9.057|35.657|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||35.657|9.057|0.0010
71031413|NCT00696020|141570834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.769|STANDARD_ERROR_OF_MEAN|6.687||0.0053|TWO_SIDED|95.0|5.613|31.924|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||31.924|5.613|0.0053
71031414|NCT00696020|141570834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.954|STANDARD_ERROR_OF_MEAN|6.805|<|0.0001|TWO_SIDED|95.0|13.565|40.343|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||40.343|13.565|<0.0001
71031415|NCT00696020|141570835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.031||0.0048|TWO_SIDED|95.0|0.027|0.149|||ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.149|0.027|0.0048
71031416|NCT00696020|141570835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.031||0.0056|TWO_SIDED|95.0|0.025|0.146|||ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.146|0.025|0.0056
71031417|NCT00696020|141570835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001|TWO_SIDED|95.0|0.066|0.189|||ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.189|0.066|<0.0001
71008716|NCT02055976|141525246|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.701|STANDARD_ERROR_OF_MEAN|1.793||0.173|TWO_SIDED|95.0|-5.264|1.862|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.862|-5.264|0.173
71031418|NCT00696020|141570836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.056||0.0332|TWO_SIDED|95.0|0.01|0.23|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.230|0.010|0.0332
71031419|NCT00696020|141570836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|STANDARD_ERROR_OF_MEAN|0.055||0.0011|TWO_SIDED|95.0|0.074|0.292|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.292|0.074|0.0011
71031420|NCT00696020|141570836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|0.128|0.349|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.349|0.128|<0.0001
71031421|NCT00696020|141570837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.867|STANDARD_ERROR_OF_MEAN|6.813||0.0009|TWO_SIDED|95.0|9.462|36.272|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||36.272|9.462|0.0009
70910152|NCT02300311|141309122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.37|||<|0.0001|TWO_SIDED|95.0|5.342|24.199|||Regression, Logistic|Ordinal logistic regression models adjusting for the continuous covariate 'baseline PI' and the categorical variable 'country' was performed.|Odds ratio of (Finalgon® cream / placebo)|"For the analysis of the repeated multinomial efficacy endpoint 'patient assessment of efficacy' on the last individual treatment day, ordinal logistic regression models is used.~Only non-missing data is analysed in the statistical model."||24.199|5.342|<0.0001
71031422|NCT00696020|141570837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.743|STANDARD_ERROR_OF_MEAN|6.739||0.0036|TWO_SIDED|95.0|6.484|33.002|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||33.002|6.484|0.0036
71031423|NCT00696020|141570837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.793|STANDARD_ERROR_OF_MEAN|6.859|<|0.0001|TWO_SIDED|95.0|14.298|41.287|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||41.287|14.298|<0.0001
71031424|NCT00696020|141570838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.033||0.0079|TWO_SIDED|95.0|0.023|0.152|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.152|0.023|0.0079
71031425|NCT00696020|141570838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.032||0.012|TWO_SIDED|95.0|0.018|0.146|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.146|0.018|0.0120
71031426|NCT00696020|141570838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.08|0.209|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.209|0.080|<0.0001
71031427|NCT00696020|141570839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.06||0.0296|TWO_SIDED|95.0|0.013|0.249|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.249|0.013|0.0296
71031428|NCT00696020|141570839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.059||0.0007|TWO_SIDED|95.0|0.087|0.32|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.320|0.087|0.0007
71031429|NCT00696020|141570839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|0.147|0.383|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.383|0.147|<0.0001
71031430|NCT00696020|141570840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.414|STANDARD_ERROR_OF_MEAN|7.057||0.001|TWO_SIDED|95.0|9.529|37.3|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||37.300|9.529|0.0010
71031431|NCT00696020|141570840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.695|STANDARD_ERROR_OF_MEAN|6.981||0.0078|TWO_SIDED|95.0|4.961|32.43|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||32.430|4.961|0.0078
71031432|NCT00696020|141570840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.357|STANDARD_ERROR_OF_MEAN|7.105|<|0.0001|TWO_SIDED|95.0|15.379|43.335|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||43.335|15.379|<0.0001
71031433|NCT00696020|141570842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.048||0.3517|TWO_SIDED|95.0|-0.049|0.138|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.138|-0.049|0.3517
71031434|NCT00696020|141570842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.048||0.3171|TWO_SIDED|95.0|-0.046|0.143|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.143|-0.046|0.3171
71031435|NCT00696020|141570842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.048||0.4654|TWO_SIDED|95.0|-0.06|0.13|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.130|-0.060|0.4654
71031436|NCT00696020|141570843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.106|STANDARD_ERROR_OF_MEAN|7.704||0.0899|TWO_SIDED|95.0|-2.055|28.267|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||28.267|-2.055|0.0899
71031437|NCT00696020|141570843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.817|STANDARD_ERROR_OF_MEAN|7.759||0.0111|TWO_SIDED|95.0|4.549|35.084|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||35.084|4.549|0.0111
71031438|NCT00696020|141570843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.893|STANDARD_ERROR_OF_MEAN|7.844||0.0166|TWO_SIDED|95.0|3.458|34.329|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||34.329|3.458|0.0166
71031439|NCT01387022|141570856|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
71031440|NCT01387022|141570857|SUPERIORITY_OR_OTHER|||||||0.481|||||||Wilcoxon (Mann-Whitney)|||||||0.481
71031441|NCT01387022|141570859|SUPERIORITY_OR_OTHER|||||||0.267|||||||Fisher Exact|||||||0.267
71031442|NCT00904345|141570876|OTHER||||||||||||||||||Estimates of proportion event-free at 1 and 2 years calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals were calculated by the Greenwood method. All analyses were performed using SAS v9.4 software and R version 3.5.2.|||
71031443|NCT00904345|141570877|OTHER||||||||||||||||||Survival proportion estimates at 1 and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method. All analyses were performed using SAS v9.4 software and R version 3.5.2.|||
71031444|NCT00904345|141570881|OTHER||||||||||||||||||Estimates of proportion LRP event-free at 1 and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method. All analyses were performed using SAS v9.4 software and R version 3.5.2.|||
71031445|NCT02495467|141570882|SUPERIORITY||Mean Difference (Final Values)|1.03||||0.0132|TWO_SIDED|95.0|0.22|1.84|||Mixed Models Analysis|||||1.84|0.22|0.0132
70910153|NCT00811187|141309135|SUPERIORITY|\[Not Specified\]|Mean Difference (Net)|-2.03|||<|0.001|TWO_SIDED||||||Regression, Linear||Treatment pain difference= Lidocaine (0.97) - Placebo (3.00).|A sample size calculation and power analysis was conducted using PS Power and Sample Size Calculations 2.1.30 (Vanderbilt University, Department of Biostatistics, Nashville, TN) to determine necessary sample size.||||<.001
70910154|NCT00994279|141309228|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53|TWO_SIDED||||||Chi-squared|||Null hypothesis is that the two arms will not differ in retention at 14 weeks.||||.53
70910155|NCT00994279|141309229|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98|TWO_SIDED||||||Mixed Models Analysis|||Null hypothesis is that the two groups would not differ in fatigue at 10 weeks.||||.98
70910156|NCT04833855|141309230|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|2.2||0.99|TWO_SIDED|95.0|-4.3|4.4||Nominal p-value|Repeated measure model|Model parameters: stratification factor (prior anti-IgE status), baseline UAS7, treatment, study week, interaction between treatment and study week.|Tezepelumab 210 mg SC Q4W - Placebo|||4.4|-4.3|0.99
70910157|NCT04833855|141309230|SUPERIORITY||LSM difference|-1.1|STANDARD_ERROR_OF_MEAN|2.2||0.6|TWO_SIDED|95.0|-5.4|3.1||Nominal p-value|Repeated measure model|Model parameters: stratification factor (prior anti-IgE status), baseline UAS7, treatment, study week, interaction between treatment and study week.|Tezepelumab 420 mg SC Q2W - Placebo|||3.1|-5.4|0.60
70910158|NCT04883346|141309329|SUPERIORITY||Mean Difference (Final Values)|-3.2|STANDARD_DEVIATION|3.4|<|0.001|TWO_SIDED||||||t-test, 2 sided|Paired t-test, 32 degrees of freedom (one participant did not have baseline DEXA data so could not be included.||||||<0.001
70910159|NCT04883346|141309330|SUPERIORITY||Mean Difference (Final Values)|-1.7|STANDARD_DEVIATION|1.5|<|0.001|TWO_SIDED||||||t-test, 2 sided|Paired t-test, 33 degrees of freedom.||||||<0.001
70910160|NCT04883346|141309331|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_DEVIATION|0.1|<|0.001|TWO_SIDED||||||t-test, 2 sided|Paired t-test, 33 degrees of freedom||||||<0.001
71031446|NCT02495467|141570883|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.0122|TWO_SIDED|95.0|0.09|0.73|||Mixed Models Analysis|||||0.73|0.09|0.0122
71031447|NCT02495467|141570884|SUPERIORITY||Mean Difference (Final Values)|0.39|||<|0.0001|TWO_SIDED|95.0|0.21|0.57|||Mixed Models Analysis|||||0.57|0.21|<0.0001
70910161|NCT04883346|141309332|SUPERIORITY|Paired t-test.|Mean Difference (Final Values)|-4.4|STANDARD_DEVIATION|4.4|<|0.001|TWO_SIDED||||||t-test, 2 sided|Paired t-test, 33 degrees of freedom||||||<0.001
70910162|NCT04529538|141309341|OTHER||GMT Ratio|0.68|||||TWO_SIDED|95.0|0.252|1.838|||||GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.|Comparison of Type 1 neutralizing antibody GMT at Day 29||1.838|0.252|
70910163|NCT04529538|141309342|OTHER||GMT Ratio|1.26|||||TWO_SIDED|95.0|0.232|6.833|||||GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.|Comparison of type 1 neutralizing antibody GMT at Day 29||6.833|0.232|
70910164|NCT04529538|141309342|OTHER||GMT Ratio|1.98|||||TWO_SIDED|95.0|0.603|6.528|||||GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.|Comparison of type 1 neutralizing antibody GMT at Day 57||6.528|0.603|
70910165|NCT04529538|141309343|OTHER||GMT Ratio|1.56|||||TWO_SIDED|95.0|0.639|3.828|||||GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.|Comparison of type 3 neutralizing antibody GMT at Day 29||3.828|0.639|
70910166|NCT04529538|141309344|OTHER||GMT Ratio|1.79|||||TWO_SIDED|95.0|0.772|4.163|||||GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.|Comparison of type 3 neutralizing antibody GMT at Day 29||4.163|0.772|
70910167|NCT04529538|141309344|OTHER||GMT Ratio|2.51|||||TWO_SIDED|95.0|0.994|6.34|||||GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.|Comparison of type 3 neutralizing antibody GMT at Day 57||6.340|0.994|
70910168|NCT04529538|141309345|OTHER||Rate Difference|-4.0|||>|0.999|TWO_SIDED|95.0|-27.67|22.72|||Fisher Exact||Rate Difference = nOPV - mOPV|Between-Group Seroconversion Rate (4-fold rise) in Neutralizing Antibody Titers||22.72|-27.67|>0.999
70910169|NCT04529538|141309346|OTHER||Rate Difference|-2.8|||>|0.999|TWO_SIDED|95.0|-20.47|20.86|||Fisher Exact||Rate Difference = nOPV - mOPV|Between-group seroconversion rate (4-fold rise) in neutralizing antibody titers 28 days after first dose.||20.86|-20.47|>0.999
70910170|NCT04529538|141309346|OTHER||Rate Difference|8.3||||0.263|TWO_SIDED|95.0|-5.71|30.57|||Fisher Exact||Rate Difference = nOPV - mOPV|Between-group comparison of seroconversion rate (4-fold rise) in neutralizing antibody titers 28 days after 2nd dose.||30.57|-5.71|0.263
70910171|NCT04529538|141309347|OTHER||Rate Difference|14.3||||0.224|TWO_SIDED|95.0|-8.3|40.45|||Fisher Exact||Rate Difference = nOPV - mOPV|Between-group seroconversion rate (4-fold rise) in neutralizing antibody titers 28 days after vaccination||40.45|-8.30|0.224
70910172|NCT04529538|141309348|OTHER||Rate Difference|9.8||||0.275|TWO_SIDED|95.0|-7.29|35.19|||Fisher Exact||Rate Difference = nOPV - mOPV|Between-group comparison of seroconversion rate (4-fold rise) in neutralizing antibody titers 28 days after first dose.||35.19|-7.29|0.275
70910173|NCT04529538|141309348|OTHER||Rate Difference|17.9||||0.1|TWO_SIDED|95.0|-1.27|44.93|||Fisher Exact||Rate Difference = nOPV - mOPV|Between-group comparison of seroconversion rate (4-fold rise) in neutralizing antibody titers 28 days after 2nd dose.||44.93|-1.27|0.100
71031448|NCT02495467|141570885|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.0055|TWO_SIDED|95.0|0.12|0.69|||Mixed Models Analysis|||||0.69|0.12|0.0055
71031449|NCT02495467|141570886|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.001|TWO_SIDED|95.0|0.2|0.76|||Mixed Models Analysis|||||0.76|0.20|0.001
71031450|NCT02495467|141570887|SUPERIORITY||Means ratio|0.995||||0.7999|TWO_SIDED|95.0|0.96|1.032|||Generalized Linear Mixed Model|||||1.032|0.960|0.7999
71031451|NCT02495467|141570888|SUPERIORITY||Means ratio|0.989||||0.6746|TWO_SIDED|95.0|0.937|1.043|||Generalized Linear Mixed Model|||||1.043|0.937|0.6746
70910174|NCT02322775|141309357|SUPERIORITY_OR_OTHER||Difference of Least Square Means|0.08||||0.04|TWO_SIDED|95.0|0.0|0.15||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||The null hypothesis was: H0: Change from baseline in pre-bronchodilator FEV1 (L) at Week 12 (benralizumab vs placebo)=0.||0.15|0|0.040
70910175|NCT02322775|141309358|SUPERIORITY_OR_OTHER||Difference of Least Square Means|8.84||||0.233|TWO_SIDED|95.0|-5.74|23.42||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||||23.42|-5.74|0.233
70910176|NCT02322775|141309359|SUPERIORITY_OR_OTHER||Difference of Least Square Means|5.29||||0.456|TWO_SIDED|95.0|-8.67|19.25||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||||19.25|-8.67|0.456
70910177|NCT02322775|141309360|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-0.13||||0.266|TWO_SIDED|95.0|-0.35|0.1||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||||0.10|-0.35|0.266
70910178|NCT02322775|141309361|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-0.36||||0.2|TWO_SIDED|95.0|-0.91|0.19||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||||0.19|-0.91|0.200
70910179|NCT02322775|141309362|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-0.03||||0.38|TWO_SIDED|95.0|-0.08|0.03||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||||0.03|-0.08|0.380
70910180|NCT02322775|141309363|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-0.17||||0.114|TWO_SIDED|95.0|-0.39|0.04||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||||0.04|-0.39|0.114
70910181|NCT02322775|141309365|SUPERIORITY_OR_OTHER||Difference of Least Square Means|0.21||||0.055|TWO_SIDED|95.0|0.0|0.42||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|ANCOVA|||Parameter: Total score||0.42|0|0.055
70910182|NCT02322775|141309365|SUPERIORITY_OR_OTHER||Difference of Least Square Means|0.23||||0.063|TWO_SIDED|95.0|-0.01|0.47||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|ANCOVA|||Parameter: Symptoms score||0.47|-0.01|0.063
70910183|NCT02322775|141309365|SUPERIORITY_OR_OTHER||Difference of Least Square Means|0.2||||0.061|TWO_SIDED|95.0|-0.01|0.41||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|ANCOVA|||Parameter: Activity limitation score||0.41|-0.01|0.061
70910184|NCT02322775|141309365|SUPERIORITY_OR_OTHER||Difference of Least Square Means|0.19||||0.156|TWO_SIDED|95.0|-0.07|0.45||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|ANCOVA|||Parameter: Emotional function score||0.45|-0.07|0.156
70910185|NCT02322775|141309365|SUPERIORITY_OR_OTHER||Difference of Least Square Means|0.19||||0.135|TWO_SIDED|95.0|-0.06|0.44||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|ANCOVA|||Parameter: Environmental stimuli score||0.44|-0.06|0.135
70910186|NCT01641861|141309368|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.1|7.3||||||||7.3|0.1|
70910187|NCT01641861|141309369|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.5|||||TWO_SIDED|95.0|0.9|12.8||||||||12.8|0.9|
70910188|NCT01641861|141309371|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.001
70910189|NCT01641861|141309372|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.001
70910190|NCT05567952|141309373|SUPERIORITY||Least square (LS) mean difference|-0.705|||=|0.0004|TWO_SIDED|95.0|-1.093|-0.316|||MMRM|||Mixed model for repeated measures (MMRM) included fixed effects of treatment, geographic region, baseline SARS-CoV-2 RNA level, visit, and treatment-by-visit interaction; an unstructured (co) variance structure was used.||-0.316|-1.093|= 0.0004
70910191|NCT05567952|141309374|SUPERIORITY||Hazard Ratio (HR)|1.235|||=|0.0697|TWO_SIDED|95.0|0.983|1.551|||COX proportional hazard ratio|||Analysis was based on Cox proportional hazard (PH) model which included treatment, geographic region, baseline SARS-CoV-2 RNA level (\< 4 log10 copies/mL or \>= 4 log10 copies/mL) and time since the last vaccination (less than or equal to \[\<=6\] months, \> 6 months or unvaccinated) as appropriate.||1.551|0.983|= 0.0697
70910192|NCT05567952|141309375|SUPERIORITY||Hazard Ratio (HR)|1.084|||=|0.5202|TWO_SIDED|95.0|0.848|1.385|||COX proportional hazard ratio|||Analysis was based on Cox proportional hazard (PH) model which included treatment, geographic region, baseline SARS-CoV-2 RNA level (\< 4 log10 copies/mL or \>= 4 log10 copies/mL) and time since the last vaccination (\<=6 months, \> 6 months or unvaccinated) as appropriate.||1.385|0.848|= 0.5202
70910193|NCT00777803|141309377|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% Newcombe confidence interval for proportions (paired data) was applied. The lower bound of the Newcombe-Wilson confidence interval of the difference in response rates between groups was compared to the non-inferiority margin of -15%.|difference of response rates|0.7|||||TWO_SIDED|95.0|-3.2|7.1|||||Difference of response rates = response rate in IncobotulinumtoxinA (Xeomin®/Bocouture®) - response rate in OnabotulinumtoxinA (Vistabel®)|Null Hypothesis: Response rate of IncobotulinumtoxinA (Xeomin®/Bocouture®) minus the response rate of OnabotulinumtoxinA (Vistabel®) is lower or equal -15% (non-inferiority margin).||7.1|-3.2|
70910194|NCT04213846|141309391|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 1-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 1-Month Follow-Up.|Count/Rate Ratio|0.94||||0.34|TWO_SIDED|95.0|0.81|1.07|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 1-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.07|0.81|0.34
70910195|NCT04213846|141309391|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 6-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 6-Month Follow-Up.|Count/Rate Ratio|1.09||||0.37|TWO_SIDED|95.0|0.91|1.3|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 6-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.30|0.91|0.37
71031452|NCT02495467|141570889|SUPERIORITY||Means ratio|1.075||||0.0959|TWO_SIDED|95.0|0.987|1.17|||Generalized Linear Mixed Model|||||1.170|0.987|0.0959
71031453|NCT02495467|141570890|SUPERIORITY||Means ratio|1.522|||<|0.0001|TWO_SIDED|95.0|1.267|1.829|||Generalized Linear Mixed Model|||||1.829|1.267|<0.0001
70910196|NCT04213846|141309391|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 12-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 12-Month Follow-Up.|Count/Rate Ratio|1.02||||0.8|TWO_SIDED|95.0|0.85|1.23|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 12-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.23|0.85|0.80
70910197|NCT04213846|141309392|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 1-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 1-Month Follow-Up.|Count/Rate Ratio|1.02||||0.75|TWO_SIDED|95.0|0.88|1.2|||Generalized linear mixed model|Models controlled for sex, age, college type and used a Poisson error distribution. Peak eBAC multiplied by 100 and rounded up to the nearest integer.||Changes from Baseline to 1-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.20|0.88|0.75
70910198|NCT04213846|141309392|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 6-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 6-Month Follow-Up.|Count/Rate Ratio|1.04||||0.72|TWO_SIDED|95.0|0.86|1.25|||Generalized linear mixed model|Models controlled for sex, age, college type and used a Poisson error distribution. Peak eBAC multiplied by 100 and rounded up to the nearest integer.||Changes from Baseline to 6-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.25|0.86|0.72
70910199|NCT04213846|141309392|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 12-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 12-Month Follow-Up.|Count/Rate Ratio|1.01||||0.91|TWO_SIDED|95.0|0.85|1.21|||Generalized linear mixed model|Models controlled for sex, age, college type and used a Poisson error distribution. Peak eBAC multiplied by 100 and rounded up to the nearest integer.||Changes from Baseline to 12-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.21|0.85|0.91
70910200|NCT04213846|141309393|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 1-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 1-Month Follow-Up.|Count/Rate Ratio|0.83||||0.04|TWO_SIDED|95.0|0.69|0.99|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 1-Month Follow-Up for intervention versus assessment-only control reported in this section.||0.99|0.69|0.04
70910201|NCT04213846|141309393|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 6-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 6-Month Follow-Up.|Count/Rate Ratio|0.98||||0.84|TWO_SIDED|95.0|0.77|1.23|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 6-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.23|0.77|0.84
70910202|NCT04213846|141309393|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 12-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 12-Month Follow-Up.|Count/Rate Ratio|0.9||||0.34|TWO_SIDED|95.0|0.73|1.22|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 12-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.22|0.73|0.34
70910203|NCT04213846|141309394|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 1-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 1-Month Follow-Up.|Count/Rate Ratio|0.98||||0.78|TWO_SIDED|95.0|0.82|1.16|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 1-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.16|0.82|0.78
70910204|NCT04213846|141309394|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 6-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 6-Month Follow-Up.|Count/Rate Ratio|0.9||||0.27|TWO_SIDED|95.0|0.75|1.08|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 6-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.08|0.75|0.27
70910205|NCT04213846|141309394|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 12-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 12-Month Follow-Up.|Count/Rate Ratio|1.01||||0.95|TWO_SIDED|95.0|0.84|1.2|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 12-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.20|0.84|0.95
70910206|NCT04213846|141309395|SUPERIORITY|Generalized linear model was estimated using a sample of N=346.|Count/Rate Ratio|0.98||||0.69|TWO_SIDED|95.0|0.89|1.08|||Generalized linear mixed model|Model controlled for sex, age, and college type (2-year vs. 4-year) and used a negative binomial error distribution.||Changes from Baseline to 12-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.08|0.89|0.69
71031454|NCT02495467|141570891|SUPERIORITY||Means ratio|1.32||||0.0005|TWO_SIDED|95.0|1.128|1.545|||Generalized Linear Mixed Model|||||1.545|1.128|0.0005
71031455|NCT02495467|141570892|SUPERIORITY||||||<|0.0001|||||||Prescott Test (Exact)|||||||<0.0001
71031456|NCT02495467|141570893|SUPERIORITY|||||||0.0003|||||||Prescott Test (Exact)|||||||0.0003
70850182|NCT02785770|141188247|SUPERIORITY_OR_OTHER||LS mean difference|0.96||||0.454|TWO_SIDED|90.0|-1.15|3.07|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||3.07|-1.15|0.4540
70850183|NCT02785770|141188247|SUPERIORITY_OR_OTHER||LS mean difference|7.88|||<|0.0001|TWO_SIDED|90.0|5.77|9.99|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||9.99|5.77|< 0.0001
70850184|NCT02785770|141188247|SUPERIORITY_OR_OTHER||LS mean difference|11.33|||<|0.0001|TWO_SIDED|90.0|9.22|13.44|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||13.44|9.22|< 0.0001
70850185|NCT02785770|141188247|SUPERIORITY_OR_OTHER||LS mean difference|8.59|||<|0.0001|TWO_SIDED|90.0|6.48|10.7|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||10.70|6.48|< 0.0001
70850186|NCT02785770|141188247|SUPERIORITY_OR_OTHER||LS mean difference|8.96|||<|0.0001|TWO_SIDED|90.0|6.85|11.07|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||11.07|6.85|< 0.0001
70850187|NCT02785770|141188247|SUPERIORITY_OR_OTHER||LS mean difference|8.07|||<|0.0001|TWO_SIDED|90.0|5.96|10.18|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||10.18|5.96|< 0.0001
70910207|NCT05516342|141309438|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
70910208|NCT05516342|141309439|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
70910209|NCT05516342|141309440|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
70910210|NCT05516342|141309441|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
70910211|NCT05516342|141309442|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
70910212|NCT05516342|141309443|SUPERIORITY|||||||0.89|||||||ANOVA|||||||0.89
70910213|NCT05516342|141309444|SUPERIORITY|||||||0.27|||||||ANOVA|||||||0.27
70910214|NCT05516342|141309445|SUPERIORITY|||||||0.19|||||||ANOVA|||||||0.19
70910215|NCT05516342|141309446|SUPERIORITY|||||||0.1|||||||ANOVA|||||||0.10
70910216|NCT01115998|141309447|SUPERIORITY_OR_OTHER|||||||0.02||||||The a priori alpha level was \< 0.10 and was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Mobility functional skills~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.02
70910217|NCT01115998|141309447|SUPERIORITY_OR_OTHER|||||||0.52||||||The a priori alpha level was \<0.10 and was not adjusted for multiple comparisons|Wilcoxon Signed-Rank Test|||"Self-care functional skills~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.52
70910218|NCT01115998|141309447|SUPERIORITY_OR_OTHER|||||||0.38||||||The a priori alpha level was 0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Social function functional skills~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.38
70910219|NCT01115998|141309447|SUPERIORITY_OR_OTHER|||||||0.03||||||The a priori alpha level was 0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Mobility care giver assistance.~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.03
70910220|NCT01115998|141309447|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon Signed-Rank Test|The a priori alpha level was 0.10 and it was not adjusted for multiple comparisons.||"Self-care caregiver assistance~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||.006
70910221|NCT01115998|141309447|SUPERIORITY_OR_OTHER|||||||0.45||||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Social function caregiver assistance~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.45
70910222|NCT01115998|141309448|SUPERIORITY_OR_OTHER|||||||0.92||||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Adaptive total~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.92
71031457|NCT02193165|141570904|SUPERIORITY_OR_OTHER|||||||0.434|TWO_SIDED||||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. Baseline groups are balanced and baseline scores for each intervention group should not be significantly different. Significance will be determined by p\<0.5||||0.434
70910223|NCT01115998|141309448|SUPERIORITY_OR_OTHER|||||||0.38||||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Cognitive total~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.38
70910224|NCT01115998|141309448|SUPERIORITY_OR_OTHER|||||||0.42||90.0||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Communication total~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.42
70910225|NCT01115998|141309448|SUPERIORITY_OR_OTHER|||||||0.57||||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Motor total~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.57
70910226|NCT01115998|141309448|SUPERIORITY_OR_OTHER|||||||0.69||||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Personal-social total~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.69
70910227|NCT01115998|141309448|SUPERIORITY_OR_OTHER|||||||0.28||||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"BID total score~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.28
70910228|NCT01115998|141309449|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Wilcoxon Signed-Rank Test|||"Reactive scale~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||>0.10
70910229|NCT01115998|141309449|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Wilcoxon Signed-Rank Test|||"Self Initiated Scale~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||>0.10
70910230|NCT03850444|141309450|OTHER||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.38|1.0|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), and histology (squamous vs. non-squamous).|||1.00|0.38|
70910231|NCT03850444|141309451|OTHER||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.41|0.95|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).|||0.95|0.41|
70910232|NCT03850444|141309452|OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.45|0.94|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).|||0.94|0.45|
70910233|NCT03850444|141309453|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.57|1.28|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), and histology (squamous vs. non-squamous).|||1.28|0.57|
70910234|NCT03850444|141309454|OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.7|1.39|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).|||1.39|0.70|
70910235|NCT03850444|141309455|OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.74|1.35|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).|||1.35|0.74|
70910236|NCT03850444|141309456|OTHER||Difference in Percentage (DP)|17.2|||||TWO_SIDED|95.0|1.8|31.6|||Stratified Miettinen and Nurminen||DP for pembrolizumab vs. chemotherapy based on Miettinen \& Nurminen method stratified by ECOG PS (0 vs. 1) and histology (squamous vs. non-squamous).|||31.6|1.8|
70910237|NCT03850444|141309457|OTHER||Difference in Percentage (DP)|11.3|||||TWO_SIDED|95.0|-1.4|23.7|||||DP for pembrolizumab vs. chemotherapy based on Miettinen \& Nurminen method stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).|||23.7|-1.4|
70910238|NCT03850444|141309458|OTHER||Difference in Percentage (DP)|8.0|||||TWO_SIDED|95.0|-3.0|18.9|||||DP for pembrolizumab vs. chemotherapy based on Miettinen \& Nurminen method stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).|||18.9|-3.0|
70910239|NCT02107274|141309484|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value of less than 0.05 was considered as significant.|t-test, 1 sided|||"Sputum volume were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
70910240|NCT02107274|141309484|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value of less than 0.05 was considered significant.|t-test, 1 sided|||"Sputum volume were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
70910241|NCT02107274|141309485|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value of less than 0.05 was considered as significant.|t-test, 1 sided|||"SGRQ scores were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
70910242|NCT02107274|141309485|SUPERIORITY_OR_OTHER||||||<|0.01||||||p valu of less than 0.05 was considered significant.|t-test, 1 sided|||"SGRQ scores were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables"||||<0.01
70910243|NCT02107274|141309486|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value of less than 0.05 was considered as significant.|t-test, 1 sided|||"FEV1 values were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
70910244|NCT02107274|141309486|SUPERIORITY_OR_OTHER||||||<|0.01||||||p value of less than 0.05 was considered significant|t-test, 1 sided|||"FEV1 values were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
70910245|NCT02107274|141309487|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value of less than 0.05 was considered as significant.|t-test, 1 sided|||"FVC values were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
70910246|NCT02107274|141309487|SUPERIORITY_OR_OTHER||||||<|0.01||||||p value of less than 0.05 was considered significant.|t-test, 1 sided|||"FVC values were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
70910247|NCT03251144|141309513|OTHER||Mean Difference (Final Values)|20.0|STANDARD_ERROR_OF_MEAN|3.0|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
70910248|NCT05305040|141309515|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.049||0.5603|TWO_SIDED|95.0|-0.09|0.1||1-sided p-value|ANCOVA|||||0.10|-0.09|0.5603
70910249|NCT04365413|141309535|OTHER||Median Difference (Final Values)|0.069|||<|0.0001|TWO_SIDED||||||Paired t-test|||||||<0.0001
70910250|NCT04365413|141309536|OTHER||Median Difference (Final Values)|0.042|||<|0.0001|TWO_SIDED||||||Paired t-test|||||||<0.0001
70910251|NCT00519779|141309538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0033|STANDARD_ERROR_OF_MEAN|0.09||0.97|TWO_SIDED|95.0|-0.18|0.18|||Mixed Models Analysis|adjusted for baseline value, visit, gender, SAD||||0.18|-0.18|0.97
70910252|NCT00519779|141309539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.11||0.04|TWO_SIDED|95.0|-0.44|-0.011|||Mixed Models Analysis|||||-0.011|-0.44|0.04
70910253|NCT00519779|141309540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.076|STANDARD_ERROR_OF_MEAN|0.039||0.06|TWO_SIDED|95.0|-0.15|0.002|||Mixed Models Analysis|||||0.002|-0.15|0.06
70910254|NCT00519779|141309541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.072||0.04|TWO_SIDED|95.0|-0.3|-0.009|||Mixed Models Analysis|||||-0.009|-0.30|0.04
70910255|NCT00519779|141309542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.086||0.08|TWO_SIDED|95.0|-0.33|0.018|||Mixed Models Analysis|||||0.018|-0.33|0.08
70910256|NCT00519779|141309543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.14||0.93|TWO_SIDED|95.0|-0.26|0.29|||Mixed Models Analysis|||||0.29|-0.26|0.93
70910257|NCT04004208|141309578|NON_INFERIORITY|Non inferiority margin is 5%. Confidence interval actually refers to a credible interval based on the Bayesian analysis.|Difference in proportions|0.034|||||TWO_SIDED|90.0|-0.08|0.162||||||Bayesian analysis with non-informative prior distributions. Calculation of two-sided 90% credible interval for the treatment difference (aflibercept - laser photocoagulation).||0.162|-0.08|
70910258|NCT04004208|141309579|OTHER|Confidence interval actually refers to a credible interval based on the Bayesian analysis.|Difference in proportions|-0.023|||||TWO_SIDED|90.0|-0.11|0.046||||||Bayesian analysis with non-informative prior distributions. Calculation of two-sided 90% credible interval for the treatment difference (aflibercept - laser photocoagulation).||0.046|-0.11|
70910259|NCT04004208|141309580|OTHER|Confidence interval actually refers to a credible interval based on the Bayesian analysis.|Difference in proportions|0.096|||||TWO_SIDED|90.0|0.019|0.175||||||Bayesian analysis with non-informative prior distributions. Calculation of two-sided 90% credible interval for the treatment difference (aflibercept - laser photocoagulation).||0.175|0.019|
70910260|NCT02400307|141309593|EQUIVALENCE|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|Geometric Least-Square Mean (GLSM) Ratio|72.63|||||TWO_SIDED|90.0|48.8|108.1||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.||108.10|48.80|
70910261|NCT02400307|141309594|EQUIVALENCE|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|GLSM Ratio|99.29|||||TWO_SIDED|90.0|79.49|124.04||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.||124.04|79.49|
70910262|NCT02400307|141309595|EQUIVALENCE|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|GLSM Ratio|72.43|||||TWO_SIDED|90.0|48.54|108.07||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.||108.07|48.54|
70910263|NCT02400307|141309596|EQUIVALENCE|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|GLSM Ratio|99.02|||||TWO_SIDED|90.0|79.24|123.74||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.||123.74|79.24|
70910264|NCT02400307|141309597|EQUIVALENCE|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|GLSM Ratio|80.32|||||TWO_SIDED|90.0|59.56|108.3||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.||108.30|59.56|
71031458|NCT02193165|141570905|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between groups determined by P\<0.05||||<0.001
71031459|NCT02193165|141570906|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between groups will be determined at P\<0.05||||<0.001
71031460|NCT02193165|141570907|SUPERIORITY_OR_OTHER|||||||0.816|TWO_SIDED||||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups. Differences will be noted at P\<0.05. Baseline groups are balanced and baseline scores for each intervention group should not be significantly different||||0.816
71031461|NCT02193165|141570908|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between intervention groups will be determined @ P\<0.05||||<0.001
71031462|NCT02193165|141570909|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between intervention groups will be determined @ P\<0.05||||<0.001
71031463|NCT00678639|141570913|SUPERIORITY_OR_OTHER||Median cost difference|588.0|||||TWO_SIDED|95.0|336.0|811.0|||Hodges-Lehmann (median cost difference)|Distribution-free 95% CIs calculated using the method of Moses.|Results favored a reduced cost in the OU-CMR group.|H0: The median costs are not different among the study groups. HA: The median cost is different among groups. Power calculation was based on detecting a mean cost difference of $2000. Data was found to be non-normally distributed and therefore nonparametric comparisons were implemented.||811|336|
71092015|NCT04154956|141690616|SUPERIORITY||Hazard Ratio (HR)|0.735||||0.0305|TWO_SIDED|95.0|0.533|1.014||P-value is provided for information only, there is no statistical inference based on this P-value.|Log Rank||Hazard ratio and CIs were computed from a stratified Cox model according to stratification factors as per IRT.|||1.014|0.533|0.0305
71092016|NCT01953237|141690684|SUPERIORITY_OR_OTHER_LEGACY|||||||0.558|||||||Mixed Models Analysis|||||||0.5580
71092017|NCT02320396|141690685|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares (LS) Means|-0.83|||<|0.001|TWO_SIDED|95.0|-1.14|-0.51|||cLDA model|||The LS mean change from BL to post BL (average score of 2 weeks) in TNSS was estimated using a constrained longitudinal data analysis (cLDA) model, where both BL and post-BL measurements (average score of 2 weeks) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value.||-0.51|-1.14|<0.001
70910265|NCT02400307|141309598|EQUIVALENCE|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|GLSM Ratio|109.8|||||TWO_SIDED|90.0|87.46|137.85||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.||137.85|87.46|
70910266|NCT03688542|141309601|SUPERIORITY||Slope|-1.4|||<|0.05|TWO_SIDED|95.0|-3.8|1.0|||Regression, Linear|Dependant variable = follow-up value; adjusted for baseline value, canton, avg number of residents, mission||||1.0|-3.8|<0.05
70910267|NCT03688542|141309602|SUPERIORITY||Slope|-0.18|||<|0.05|TWO_SIDED|95.0|-0.39|0.03|||Regression, Linear|Dependant variable = number of PIM DDD at follow-up, adjusted for baseline value, canton, avg number of residents, mission||||0.03|-0.39|<0.05
70910268|NCT03688542|141309603|SUPERIORITY||Slope|-0.035|||<|0.05|TWO_SIDED|95.0|-0.095|0.025|||Regression, Linear|Dependant variable = number of PIM DDD at follow-up, adjusted for baseline value, canton, avg number of residents, mission||||0.025|-0.095|<0.05
70910269|NCT03688542|141309604|SUPERIORITY||Slope|-0.237|||<|0.05|TWO_SIDED|95.0|-0.435|-0.04|||Regression, Linear|Dependant variable = number of PIM DDD at follow-up, adjusted for baseline value, canton, avg number of residents, mission||||-0.040|-0.435|<0.05
70910270|NCT03688542|141309605|SUPERIORITY||Slope|1.55|||<|0.05|TWO_SIDED|95.0|0.164|2.938|||Regression, Linear|Dependent variable = follow-up value, adjusted for baseline value, canton, avg number of residents, interaction between mission and group.||||2.938|0.164|<0.05
70910271|NCT03688542|141309606|SUPERIORITY||Slope|-12.7|||<|0.05|TWO_SIDED|95.0|-21.5|-4.0|||Regression, Linear|Dependent variable = follow-up value, adjusted for baseline value, canton, avg number of residents, interaction between mission and group.||||-4.0|-21.5|<0.05
70910272|NCT03688542|141309607|SUPERIORITY||Slope|-0.165|||<|0.05|TWO_SIDED|95.0|-0.754|0.424|||Regression, Linear|Dependent variable = follow-up value, adjusted for baseline value, canton, avg number of residents||||0.424|-0.754|<0.05
71031464|NCT00678639|141570914|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||"H0: There is no difference in correct cardiovascular admission decisions among groups.~Ha: A difference exists among study groups. Sample size was based upon 47 analyzable participants per study arm were required to provide 88% power to detect a 30% difference in the outcome."||||<0.001
70910273|NCT03688542|141309608|SUPERIORITY||Slope|-4.2|||<|0.05|TWO_SIDED|95.0|-16.0|7.6|||Regression, Linear|Dependent variable = follow-up value, adjusted for baseline value, canton, avg number of residents||||7.6|-16.0|<0.05
70910274|NCT00083174|141309610|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.35||||0.002|TWO_SIDED|95.0|0.18|0.7|||Log Rank|||The null hypothesis was no difference between two groups. The sample size estimate was based on an assumption of annual invasive breast cancer rate of 0.60% in the placebo group and 0.21% in exemestane group, a relative reduction of 65% with exemestane. To detect this with a two-sided 5% level and 90% power, a total of 38 cases of invasive breast cancer were required, projected to occur when 4560 women were randomly assigned in a 3-year period and then followed for an additional 1.2 years.||0.70|0.18|0.002
70910275|NCT00083174|141309611|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.47||||0.004|TWO_SIDED|95.0|0.27|0.79|||Log Rank|||||0.79|0.27|0.004
70910276|NCT00083174|141309612|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.36||||0.07|TWO_SIDED|95.0|0.11|1.12|||Log Rank|||||1.12|0.11|0.07
70910277|NCT03582137|141309617|SUPERIORITY||Mean Difference (Net)|-1.8049||||0.3785|TWO_SIDED|95.0|-5.8839|2.2741|||Mixed Models Analysis|||||2.2741|-5.8839|0.3785
70910278|NCT03582137|141309621|SUPERIORITY||Mean Difference (Net)|-4.4254||||0.2712|TWO_SIDED|95.0|-12.4018|3.551|||Mixed Models Analysis|||||3.5510|-12.4018|0.2712
70910279|NCT03582137|141309622|SUPERIORITY||Mean Difference (Net)|0.3133||||0.8974|TWO_SIDED|95.0|-4.5414|5.168|||Mixed Models Analysis|||||5.1680|-4.5414|0.8974
70910280|NCT03582137|141309623|SUPERIORITY||Mean Difference (Net)|0.1505||||0.4643|TWO_SIDED|95.0|-0.2882|0.5892|||Mixed Models Analysis|||||0.5892|-0.2882|0.4643
70910281|NCT03582137|141309624|SUPERIORITY||Mean Difference (Net)|-0.1188||||0.6245|TWO_SIDED|95.0|-0.6019|0.3644|||Mixed Models Analysis|||||0.3644|-0.6019|0.6245
70910282|NCT03582137|141309630|SUPERIORITY||Mean Difference (Net)|-0.3341||||0.5921|TWO_SIDED|95.0|-1.5749|0.9068|||Mixed Models Analysis|||||0.9068|-1.5749|0.5921
70910283|NCT03582137|141309631|SUPERIORITY||Mean Difference (Net)|1.9352||||0.1016|TWO_SIDED|95.0|-0.4372|4.3076|||Mixed Models Analysis|||||4.3076|-0.4372|0.1016
70910284|NCT03582137|141309632|SUPERIORITY||Mean Difference (Net)|19.686||||0.0661|TWO_SIDED|95.0|-1.3733|40.7452|||Mixed Models Analysis|||||40.7452|-1.3733|0.0661
70910285|NCT03582137|141309633|SUPERIORITY||Mean Difference (Net)|-3.2214||||0.088|TWO_SIDED|95.0|-6.9381|0.4953|||Mixed Models Analysis|||||0.4953|-6.9381|0.0880
70910286|NCT03582137|141309634|SUPERIORITY||Mean Difference (Net)|-4.9836||||0.2827|TWO_SIDED|95.0|-14.2093|4.2421|||Mixed Models Analysis|||||4.2421|-14.2093|0.2827
70910287|NCT03582137|141309635|SUPERIORITY||Mean Difference (Net)|0.576||||0.7703|TWO_SIDED|95.0|-3.3697|4.5216|||Mixed Models Analysis|||||4.5216|-3.3697|0.7703
70910288|NCT03582137|141309636|SUPERIORITY||Mean Difference (Net)|-0.8834||||0.1874|TWO_SIDED|95.0|-2.2172|0.4504|||Mixed Models Analysis|||||0.4504|-2.2172|0.1874
70910289|NCT03582137|141309639|SUPERIORITY||Mean Difference (Net)|1.2993||||0.1646|TWO_SIDED|95.0|-0.5533|3.1519|||Mixed Models Analysis|||||3.1519|-0.5533|0.1646
70910290|NCT03582137|141309640|SUPERIORITY||Mean Difference (Net)|-1.7519||||0.1093|TWO_SIDED|95.0|-3.9082|0.4045|||Mixed Models Analysis|||||0.4045|-3.9082|0.1093
70910291|NCT03582137|141309641|SUPERIORITY||Mean Difference (Net)|1.3532||||0.1819|TWO_SIDED|95.0|-0.6511|3.3576|||Mixed Models Analysis|||||3.3576|-0.6511|0.1819
70910292|NCT03582137|141309642|SUPERIORITY||Mean Difference (Net)|0.9667||||0.2282|TWO_SIDED|95.0|-0.6287|2.5621|||Mixed Models Analysis|||||2.5621|-0.6287|0.2282
70910293|NCT03582137|141309643|SUPERIORITY||Mean Difference (Net)|-0.2614||||0.6167|TWO_SIDED|95.0|-1.3002|0.7775|||Mixed Models Analysis|||||0.7775|-1.3002|0.6167
70910294|NCT03582137|141309644|SUPERIORITY||Mean Difference (Net)|0.3067||||0.8378|TWO_SIDED|95.0|-2.6765|3.2899|||Mixed Models Analysis|||||3.2899|-2.6765|0.8378
70910295|NCT03582137|141309646|SUPERIORITY||Mean Difference (Net)|0.3237||||0.2103|TWO_SIDED|95.0|-0.188|0.8353|||Mixed Models Analysis|||||0.8353|-0.1880|0.2103
71031465|NCT00986245|141570919|NON_INFERIORITY_OR_EQUIVALENCE|80% power|Mean Difference (Net)|0.4|||<|0.05|||||||Sign test|||The UPDRS-part3 was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test.||||<0.05
70910296|NCT03582137|141309647|SUPERIORITY||Mean Difference (Net)|-0.504||||0.7197|TWO_SIDED|95.0|-3.3015|2.2934|||Mixed Models Analysis|||||2.2934|-3.3015|0.7197
71092018|NCT02320396|141690688|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.82|||<|0.001|TWO_SIDED|95.0|-1.14|-0.5|||cLDA model|||"Change from BL in TNSS at Week 1: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in TNSS was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.50|-1.14|<0.001
71092019|NCT02320396|141690688|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.84|||<|0.001|TWO_SIDED|95.0|-1.23|-0.46|||cLDA model|||"Change from BL in TNSS at Week 2: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in TNSS was estimated using a cLDA model, where both BL and post- BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.46|-1.23|<0.001
71092020|NCT02320396|141690689|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.14|||cLDA model|||"Change from BL to Week 1 in Sneezing: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Sneezing was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.14|-0.35|<0.001
71092021|NCT02320396|141690689|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.21|||<|0.001|TWO_SIDED|95.0|-0.32|-0.1|||cLDA model|||"Change from BL to Week 1 in Rhinorrhea: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Rhinorrhea was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.10|-0.32|<0.001
71092022|NCT02320396|141690689|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.09||||0.008|TWO_SIDED|95.0|-0.16|-0.02|||cLDA model|||"Change from BL to Week 1 in Nasal Congestion: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Nasal Congestion was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.02|-0.16|0.008
71092023|NCT02320396|141690689|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.27|||<|0.001|TWO_SIDED|95.0|-0.38|-0.15|||cLDA model|||"Change from BL to Week 1 in Nasal Itching: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Nasal Itching was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.15|-0.38|<0.001
71092024|NCT02320396|141690690|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.36|-0.13|||cLDA model|||"Change from BL to Week 2 in Sneezing: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Sneezing was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.13|-0.36|<0.001
71092025|NCT02320396|141690690|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.37|-0.12|||cLDA model|||"Change from BL to Week 2 in Rhinorrhea: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Rhinorrhea was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.12|-0.37|<0.001
71092026|NCT02320396|141690690|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.09||||0.037|TWO_SIDED|95.0|-0.18|-0.01|||cLDA model|||"Change from BL to Week 2 in Nasal Congestion: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Nasal Congestion was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.01|-0.18|0.037
71092027|NCT02320396|141690690|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.26|||<|0.001|TWO_SIDED|95.0|-0.4|-0.12|||cLDA model|||"Change from BL to Week 2 in Nasal Itching: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Nasal Itching was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.12|-0.40|<0.001
71092028|NCT02320396|141690691|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.14|||cLDA model|||"Change from BL in Sneezing During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Sneezing was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.14|-0.35|<0.001
71092029|NCT02320396|141690691|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.23|||<|0.001|TWO_SIDED|95.0|-0.33|-0.12|||cLDA model|||"Change from BL in Rhinorrhea During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Rhinorrhea was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.12|-0.33|<0.001
70910297|NCT03582137|141309648|SUPERIORITY||Mean Difference (Net)|2.6158||||0.0686|TWO_SIDED|95.0|-0.2058|5.4373|||Mixed Models Analysis|||||5.4373|-0.2058|0.0686
70910298|NCT03582137|141309649|SUPERIORITY||Mean Difference (Net)|2.7891||||0.2339|TWO_SIDED|95.0|-1.8523|7.4304|||Mixed Models Analysis|||||7.4304|-1.8523|0.2339
70910299|NCT03582137|141309650|SUPERIORITY||Mean Difference (Net)|0.9536||||0.7557|TWO_SIDED|95.0|-5.1655|7.0727|||Mixed Models Analysis|||||7.0727|-5.1655|0.7557
70910300|NCT03582137|141309652|SUPERIORITY||Mean Difference (Net)|0.05126||||0.915|TWO_SIDED|95.0|-0.9086|1.0111|||Mixed Models Analysis|||||1.0111|-0.9086|0.9150
70910301|NCT03582137|141309653|SUPERIORITY||Mean Difference (Net)|-0.6699||||0.6164|TWO_SIDED|95.0|-3.3316|1.9918|||Mixed Models Analysis|||||1.9918|-3.3316|0.6164
70910302|NCT03582137|141309654|SUPERIORITY||Mean Difference (Net)|-0.1358||||0.755|TWO_SIDED|95.0|-1.0028|0.7312|||Mixed Models Analysis|||||0.7312|-1.0028|0.7550
70910303|NCT03582137|141309655|SUPERIORITY||Mean Difference (Net)|-0.09605||||0.9016|TWO_SIDED|95.0|-1.6449|1.4528|||Mixed Models Analysis|||||1.4528|-1.6449|0.9016
70910304|NCT03582137|141309656|SUPERIORITY||Mean Difference (Net)|-0.3217||||0.9219|TWO_SIDED|95.0|-6.8584|6.2151|||Mixed Models Analysis|||||6.2151|-6.8584|0.9219
70910305|NCT03582137|141309657|SUPERIORITY||Mean Difference (Net)|0.02897||||0.3178|TWO_SIDED|95.0|-0.02857|0.08651|||Mixed Models Analysis|||||0.08651|-0.02857|0.3178
70910306|NCT03582137|141309662|SUPERIORITY||Mean Difference (Net)|0.2288||||0.7693|TWO_SIDED|95.0|-1.325|1.7825|||Mixed Models Analysis|||||1.7825|-1.3250|0.7693
70910307|NCT03582137|141309663|SUPERIORITY||Mean Difference (Net)|-0.8121||||0.5285|TWO_SIDED|95.0|-3.3743|1.7501|||Mixed Models Analysis|||||1.7501|-3.3743|0.5285
70910308|NCT03582137|141309664|SUPERIORITY||Mean Difference (Net)|-0.02525||||0.9463|TWO_SIDED|95.0|-0.7717|0.7212|||Mixed Models Analysis|||||0.7212|-0.7717|0.9463
70910309|NCT03582137|141309665|SUPERIORITY||Mean Difference (Net)|-0.3042||||0.4362|TWO_SIDED|95.0|-1.0817|0.4732|||Mixed Models Analysis|||||0.4732|-1.0817|0.4362
70910310|NCT03582137|141309666|SUPERIORITY||Mean Difference (Net)|-0.06489||||0.9327|TWO_SIDED|95.0|-1.5957|1.4659|||Mixed Models Analysis|||||1.4659|-1.5957|0.9327
70910311|NCT03582137|141309669|SUPERIORITY||Mean Difference (Net)|-0.2763||||0.4401|TWO_SIDED|95.0|-0.988|0.4354|||Mixed Models Analysis|||||0.4354|-0.9880|0.4401
70910312|NCT03582137|141309670|SUPERIORITY||Mean Difference (Net)|-0.8319||||0.8085|TWO_SIDED|95.0|-7.6835|6.0197|||Mixed Models Analysis|||||6.0197|-7.6835|0.8085
70910313|NCT03582137|141309672|SUPERIORITY||Mean Difference (Net)|0.02673||||0.9674|TWO_SIDED|95.0|-1.2757|1.3292|||Mixed Models Analysis|||||1.3292|-1.2757|0.9674
70910314|NCT03582137|141309674|SUPERIORITY||Mean Difference (Net)|-46.92||||0.1128|TWO_SIDED|95.0|-105.51|11.68|||Mixed Models Analysis|||||11.68|-105.51|0.1128
70910315|NCT02303574|141309681|OTHER|Dose proportionality was analyzed by power model. Slope parameter was obtained via linear least squares.|Slope|1.287|STANDARD_ERROR_OF_MEAN|0.05085|||TWO_SIDED|95.0|1.183|1.391||||||||1.391|1.183|
70910316|NCT02303574|141309681|OTHER|Effect of food analysis by linear mixed effects ANOVA model with fixed effect of fasting status.|Ratio (%)|90.72|||||TWO_SIDED|90.0|83.72|98.31||||||||98.31|83.72|
70910317|NCT02303574|141309682|OTHER|Time dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|159.4|||||TWO_SIDED|90.0|140.61|180.7||||||||180.70|140.61|
70910318|NCT02303574|141309682|OTHER|Time dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|151.82|||||TWO_SIDED|90.0|138.23|166.74||||||||166.74|138.23|
70910319|NCT02303574|141309682|OTHER|Time dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|158.68|||||TWO_SIDED|90.0|146.67|171.67||||||||171.67|146.67|
70910320|NCT02303574|141309683|OTHER|Dose proportionality was analyzed by power model. Slope parameter was obtained via linear least squares.|Slope|1.228|STANDARD_ERROR_OF_MEAN|0.1329|||TWO_SIDED|95.0|0.9513|1.504||||||||1.504|0.9513|
70910321|NCT02303574|141309683|OTHER|ime dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|159.4|||||TWO_SIDED|90.0|140.61|180.7||||||||180.70|140.61|
70910322|NCT02303574|141309683|OTHER|ime dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|151.82|||||TWO_SIDED|90.0|138.23|166.74||||||||166.74|138.23|
70910323|NCT02303574|141309683|OTHER|ime dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|158.68|||||TWO_SIDED|90.0|146.67|171.67||||||||171.67|146.67|
70910324|NCT02303574|141309684|OTHER||Slope|1.302|STANDARD_ERROR_OF_MEAN|0.05056|||TWO_SIDED|95.0|1.198|1.406||||||Dose proportionality was analyzed by power model. Slope parameter was obtained via linear least squares.||1.406|1.198|
70910325|NCT02303574|141309684|OTHER|Effect of food analysis by linear mixed effects ANOVA model with fixed effect of fasting status.|Ratio (%)|64.14|||||TWO_SIDED|90.0|55.07|74.7||||||||74.70|55.07|
70910326|NCT02303574|141309685|OTHER|Dose proportionality was analyzed by power model. Slope parameter was obtained via linear least squares.|Slope|1.157|STANDARD_ERROR_OF_MEAN|0.1098|||TWO_SIDED|95.0|0.9285|1.385||||||||1.385|0.9285|
70910327|NCT01606189|141309718|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.58||||0.005|TWO_SIDED|95.0|-0.98|-0.18|||ANOVA|||Box Scale-11 pain scores were compared between treatment groups using an analysis of variance (ANOVA). The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Box Scale-11 Pain Score = Patient + Treatment + Period||-0.18|-0.98|0.005
70910328|NCT01606189|141309718|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.64||||0.002|TWO_SIDED|95.0|-1.03|-0.24|||ANOVA|||Box Scale-11 pain scores were compared between treatment groups using an ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Box Scale-11 Pain Score = Patient + Treatment + Period||-0.24|-1.03|0.002
70910329|NCT01606189|141309719|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.2||||0.017|TWO_SIDED|95.0|-0.37|-0.04|||ANOVA|||Sleep disturbance scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Sleep disturbance Score = Patient + Treatment + Period||-0.04|-0.37|0.017
70850188|NCT02785770|141188247|SUPERIORITY_OR_OTHER||LS mean difference|5.53|||<|0.0001|TWO_SIDED|90.0|3.42|7.64|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||7.64|3.42|< 0.0001
70850189|NCT02785770|141188247|SUPERIORITY_OR_OTHER||LS mean difference|3.74||||0.0036|TWO_SIDED|90.0|1.64|5.85|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||5.85|1.64|0.0036
70850190|NCT02785770|141188248|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-0.29||||0.8195|TWO_SIDED|90.0|-2.38|1.8|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.80|-2.38|0.8195
70850191|NCT02785770|141188248|SUPERIORITY_OR_OTHER||LS Mean Difference|4.54||||0.0004|TWO_SIDED|90.0|2.44|6.64|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||6.64|2.44|0.0004
70850192|NCT02785770|141188249|SUPERIORITY_OR_OTHER||LS mean difference|0.14||||0.9146|TWO_SIDED|90.0|-1.95|2.22|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||2.22|-1.95|0.9146
70850193|NCT02785770|141188249|SUPERIORITY_OR_OTHER||LS mean difference|5.04|||<|0.0001|TWO_SIDED|90.0|2.95|7.14|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||7.14|2.95|<0.0001
70850194|NCT02785770|141188250|SUPERIORITY_OR_OTHER||LS mean difference|1.24||||0.3272|TWO_SIDED|90.0|-0.84|3.33|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||3.33|-0.84|0.3272
70850195|NCT02785770|141188250|SUPERIORITY_OR_OTHER||LS mean difference|4.26||||0.0009|TWO_SIDED|90.0|2.16|6.36|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||6.36|2.16|0.0009
70850196|NCT02785770|141188251|SUPERIORITY_OR_OTHER||LS mean difference|-0.48||||0.7024|TWO_SIDED|90.0|-2.57|1.6|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.60|-2.57|0.7024
70850197|NCT02785770|141188251|SUPERIORITY_OR_OTHER||LS mean difference|2.26||||0.0768|TWO_SIDED|90.0|0.16|4.36|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||4.36|0.16|0.0768
70850198|NCT02785770|141188252|SUPERIORITY_OR_OTHER||LS mean difference|-1.97||||0.1201|TWO_SIDED|90.0|-4.06|0.12|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.12|-4.06|0.1201
70850199|NCT02785770|141188252|SUPERIORITY_OR_OTHER||LS mean difference|1.21||||0.3424|TWO_SIDED|90.0|-0.89|3.31|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||3.31|-0.89|0.3424
70850200|NCT02785770|141188253|SUPERIORITY_OR_OTHER||LS mean difference|-1.35||||0.287|TWO_SIDED|90.0|-3.44|0.74|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.74|-3.44|0.2870
70850201|NCT02785770|141188253|SUPERIORITY_OR_OTHER||LS mean difference|-0.11||||0.9334|TWO_SIDED|90.0|-2.21|1.99|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.99|-2.21|0.9334
70850202|NCT02785770|141188254|SUPERIORITY_OR_OTHER||LS mean difference|-2.16||||0.0893|TWO_SIDED|90.0|-4.24|-0.07|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.07|-4.24|0.0893
70850203|NCT02785770|141188254|SUPERIORITY_OR_OTHER||LS mean difference|-2.61||||0.0412|TWO_SIDED|90.0|-4.71|-0.51|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.51|-4.71|0.0412
70850204|NCT02785770|141188255|SUPERIORITY_OR_OTHER||LS mean difference|-1.34||||0.2892|TWO_SIDED|90.0|-3.43|0.74|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.74|-3.43|0.2892
70850205|NCT02785770|141188255|SUPERIORITY_OR_OTHER||LS mean difference|-2.78||||0.0294|TWO_SIDED|90.0|-4.88|-0.68|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.68|-4.88|0.0294
70850206|NCT02785770|141188256|SUPERIORITY_OR_OTHER||LS mean difference|1.28||||0.16|TWO_SIDED|90.0|-0.22|2.78|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||2.78|-0.22|0.1600
71092030|NCT02320396|141690691|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.09||||0.009|TWO_SIDED|95.0|-0.16|-0.02|||cLDA model|||"Change from BL in Nasal Congestion During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Nasal Congestion was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.02|-0.16|0.009
71092031|NCT02320396|141690691|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.26|||<|0.001|TWO_SIDED|95.0|-0.38|-0.15|||cLDA model|||"Change from BL in Nasal Itching During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Nasal Itching was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value.~cLDA model"||-0.15|-0.38|<0.001
71092032|NCT02320396|141690692|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.15|||cLDA model|||"Change from BL to Week 1 in Eye Pruritus: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Eye Pruritus was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.15|-0.35|<0.001
71092033|NCT02320396|141690692|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.16|||<|0.001|TWO_SIDED|95.0|-0.24|-0.08|||cLDA model|||"Change from BL to Week 1 in Watering Eyes: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Watering Eyes was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.08|-0.24|<0.001
71092034|NCT02320396|141690692|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.15|||cLDA model|||"Change from BL to Week 1 in Worse of Pruritus or Watering Eyes: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in the worse symptom of Pruritus or Watering Eyes estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.15|-0.35|<0.001
71092035|NCT02320396|141690693|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.37|-0.12|||cLDA model|||"Change from BL to Week 2 in Eye Pruritus: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Eye Pruritus was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.12|-0.37|<0.001
71092036|NCT02320396|141690693|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.13||||0.01|TWO_SIDED|95.0|-0.24|-0.03|||cLDA model|||"Change from BL to Week 2 in Watering Eyes: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Watering Eyes was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.03|-0.24|0.010
71092037|NCT02320396|141690693|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.24|||<|0.001|TWO_SIDED|95.0|-0.37|-0.12|||cLDA model|||"Change from BL to Week 2 in Worse of Pruritus or Watering Eyes: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in the worse symptom of Pruritus or Watering Eyes estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.12|-0.37|<0.001
71092038|NCT02320396|141690694|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.14|||cLDA model|||"Change from BL in Eye Pruritus During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Eye Pruritus was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.14|-0.35|<0.001
71092039|NCT02320396|141690694|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.15|||<|0.001|TWO_SIDED|95.0|-0.23|-0.07|||cLDA model|||"Change from BL in Watering Eyes During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Watering Eyes was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.07|-0.23|<0.001
71092040|NCT02320396|141690694|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.15|||cLDA model|||The LS mean change from BL to post BL (average score of 2 weeks) in the worse of Pruritus or Watering Eyes was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1-Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value||-0.15|-0.35|<0.001
71092041|NCT02320396|141690695|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.16|||<|0.001|TWO_SIDED|95.0|-0.24|-0.07|||cLDA model|||"Change from BL to Week 1 in Interference with Daily Activities: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Interference with Daily Activities was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.07|-0.24|<0.001
71031466|NCT00986245|141570920|NON_INFERIORITY_OR_EQUIVALENCE|80% power|Mean Difference (Net)|0.0|||<|0.05|||||||Sign test|||The Hoehn and Yahr stage was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test.||||<0.05
70910330|NCT01606189|141309719|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.33|||<|0.001|TWO_SIDED|95.0|-0.49|-0.16|||ANOVA|||Sleep disturbance scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Sleep disturbance Score = Patient + Treatment + Period||-0.16|-0.49|<0.001
70910331|NCT01606189|141309720|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.55||||0.019|TWO_SIDED|95.0|0.09|1.01|||ANOVA|||Sleep quality scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Sleep Quality Score = Patient + Treatment + Period||1.01|0.09|0.019
70910332|NCT01606189|141309720|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.79||||0.001|TWO_SIDED|95.0|0.33|1.24|||ANOVA|||Sleep quality scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Sleep Quality Score = Patient + Treatment + Period||1.24|0.33|0.001
70910333|NCT01606189|141309721|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.55||||0.146|TWO_SIDED|95.0|-3.64|0.55|||ANOVA|||Total pain intensity scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Total Pain Intensity Score = Patient + Treatment + Period||0.55|-3.64|0.146
70910334|NCT01606189|141309721|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-2.2||||0.04|TWO_SIDED|95.0|-4.29|-0.1|||ANOVA|||Total pain intensity scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Total Pain Intensity Score = Patient + Treatment + Period||-0.10|-4.29|0.040
70910335|NCT01606189|141309722|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-7.28||||0.092|TWO_SIDED|95.0|-15.78|1.21|||ANOVA|||Intensity of Pain scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Intensity of Pain Score = Patient + Treatment + Period||1.21|-15.78|0.092
70910336|NCT01606189|141309722|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-8.99||||0.037|TWO_SIDED|95.0|-17.41|-0.57|||ANOVA|||Intensity of Pain scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Intensity of Pain Score = Patient + Treatment + Period||-0.57|-17.41|0.037
70910337|NCT01606189|141309723|SUPERIORITY_OR_OTHER_LEGACY||Mann-Whitney U statistic|1222.0||||0.328||95.0|||||Wilcoxon (Mann-Whitney)|||Pain at present was analysed using the Mann-Whitney test with a correction for ties. Results were presented in terms of the sums of the ranks for the two groups, the Mann-Whitney U statistic and the associated p-value.||||0.328
70910338|NCT01606189|141309723|SUPERIORITY_OR_OTHER_LEGACY||Mann-Whitney U statistic|1200.5||||0.56||95.0|||||Wilcoxon (Mann-Whitney)|||Pain at present was analysed using the Mann-Whitney test with a correction for ties. Results were presented in terms of the sums of the ranks for the two groups, the Mann-Whitney U statistic and the associated p-value.||||0.560
70910339|NCT01606189|141309724|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.75||||0.181|TWO_SIDED|95.0|-4.32|0.83|||ANOVA|||Pain Disability Index scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Pain Disability Index Score = Patient + Treatment + Period||0.83|-4.32|0.181
70910340|NCT01606189|141309724|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.43||||0.739|TWO_SIDED|95.0|-2.12|2.98|||ANOVA|||Pain Disability Index scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Pain Disability Index Score = Patient + Treatment + Period||2.98|-2.12|0.739
70910341|NCT01606189|141309725|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-2.23||||0.015|TWO_SIDED|95.0|-4.01|-0.45|||ANOVA|||12-Item General Health Questionnaire scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: 12-Item General Health Questionnaire Score = Patient + Treatment + Period||-0.45|-4.01|0.015
70910342|NCT01606189|141309725|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.21||||0.178|TWO_SIDED|95.0|-2.97|0.56|||ANOVA|||12-Item General Health Questionnaire scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: 12-Item General Health Questionnaire Score = Patient + Treatment + Period||0.56|-2.97|0.178
70910343|NCT01167023|141309733|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-11.26||||0.304||95.0||||Pain rate was analyzed using an analysis of covariance (ANCOVA) model, with baseline pain intensity, treatment group, and stratification variable sickle-cell genotype as explanatory variables.|ANCOVA||Least Squares (LS) Mean Difference is for 5 mg prasugrel minus placebo.|||||0.304
70910344|NCT01167023|141309735|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-24.051|||<|0.001||95.0||||A mixed-effects model repeated measures analysis with baseline measurement, stratification variable sickle cell genotype, treatment, time, and time\*treatment interaction as fixed effects, and participant as a random effect in the model was used.|Mixed Models Analysis||Least Squares Mean Difference is for 5 mg prasugrel minus placebo.|||||<0.001
71031467|NCT00986245|141570921|NON_INFERIORITY_OR_EQUIVALENCE|80% power|Mean Difference (Net)|0.3|||<|0.05|||||||Sign test|||"The Overall quality of sleep was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test."||||<0.05
70850207|NCT02785770|141188256|SUPERIORITY_OR_OTHER||LS mean difference|2.38||||0.0092|TWO_SIDED|90.0|0.88|3.87|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||3.87|0.88|0.0092
70850208|NCT02785770|141188256|SUPERIORITY_OR_OTHER||LS mean difference|0.91||||0.3174|TWO_SIDED|90.0|-0.59|2.41|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||2.41|-0.59|0.3174
70850209|NCT02785770|141188256|SUPERIORITY_OR_OTHER||LS mean difference|-0.31||||0.7344|TWO_SIDED|90.0|-1.81|1.19|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.19|-1.81|0.7344
70850210|NCT02785770|141188256|SUPERIORITY_OR_OTHER||LS mean difference|0.49||||0.5881|TWO_SIDED|90.0|-1.0|1.99|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.99|-1.00|0.5881
70850211|NCT02785770|141188256|SUPERIORITY_OR_OTHER||LS mean difference|-0.82||||0.368|TWO_SIDED|90.0|-2.32|0.68|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.68|-2.32|0.3680
70850212|NCT02785770|141188256|SUPERIORITY_OR_OTHER||LS mean difference|-0.73||||0.42|TWO_SIDED|90.0|-2.23|0.76|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.76|-2.23|0.4200
70850213|NCT02785770|141188256|SUPERIORITY_OR_OTHER||LS mean difference|-3.03||||0.0009|TWO_SIDED|90.0|-4.53|-1.53|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-1.53|-4.53|0.0009
70850214|NCT02785770|141188256|SUPERIORITY_OR_OTHER||LS mean difference|4.46|||<|0.0001|TWO_SIDED|90.0|2.96|5.97|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||5.97|2.96|< 0.0001
70850215|NCT02785770|141188256|SUPERIORITY_OR_OTHER||LS mean difference|5.83|||<|0.0001|TWO_SIDED|90.0|4.32|7.33|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||7.33|4.32|< 0.0001
70850216|NCT02785770|141188256|SUPERIORITY_OR_OTHER||LS mean difference|4.09|||<|0.0001|TWO_SIDED|90.0|2.58|5.59|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||5.59|2.58|< 0.0001
70850217|NCT02785770|141188256|SUPERIORITY_OR_OTHER||LS mean difference|2.53||||0.0059|TWO_SIDED|90.0|1.02|4.03|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||4.03|1.02|0.0059
70850218|NCT02785770|141188256|SUPERIORITY_OR_OTHER||LS mean difference|2.5||||0.0063|TWO_SIDED|90.0|1.0|4.01|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||4.01|1.00|0.0063
70850219|NCT02785770|141188256|SUPERIORITY_OR_OTHER||LS mean difference|1.45||||0.1138|TWO_SIDED|90.0|-0.06|2.95|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||2.95|-0.06|0.1138
70850220|NCT02785770|141188256|SUPERIORITY_OR_OTHER||LS mean difference|-0.36||||0.6976|TWO_SIDED|90.0|-1.86|1.15|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.15|-1.86|0.6976
70850221|NCT02785770|141188256|SUPERIORITY_OR_OTHER||LS mean difference|-2.12||||0.0208|TWO_SIDED|90.0|-3.62|-0.61|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.61|-3.62|0.0208
70850222|NCT02785770|141188257|SUPERIORITY_OR_OTHER||LS mean difference|-0.64||||0.576|TWO_SIDED|90.0|-2.53|1.25|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.25|-2.53|0.5760
70850223|NCT02785770|141188257|SUPERIORITY_OR_OTHER||LS mean difference|-0.94||||0.4126|TWO_SIDED|90.0|-2.83|0.95|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.95|-2.83|0.4126
70850224|NCT02785770|141188257|SUPERIORITY_OR_OTHER||LS mean difference|-1.17||||0.3085|TWO_SIDED|90.0|-3.06|0.72|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.72|-3.06|0.3085
70850225|NCT02785770|141188257|SUPERIORITY_OR_OTHER||LS mean difference|-0.99||||0.3889|TWO_SIDED|90.0|-2.88|0.9|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.90|-2.88|0.3889
71031468|NCT00986245|141570922|NON_INFERIORITY_OR_EQUIVALENCE|80% power|Mean Difference (Net)|0.2|||<|0.05|||||||Sign test|||"The Nocturnal off-symptoms was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test."||||<0.05
71031469|NCT00986245|141570923|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|||<|0.05||||||80% power|Sign test|||"The Early morning off symptoms was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test."||||<0.05
70850226|NCT02785770|141188257|SUPERIORITY_OR_OTHER||LS mean difference|-0.57||||0.6192|TWO_SIDED|90.0|-2.46|1.32|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.32|-2.46|0.6192
70850227|NCT02785770|141188257|SUPERIORITY_OR_OTHER||LS mean difference|-2.45||||0.0332|TWO_SIDED|90.0|-4.34|-0.56|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.56|-4.34|0.0332
70850228|NCT02785770|141188257|SUPERIORITY_OR_OTHER||LS mean difference|-0.41||||0.7224|TWO_SIDED|90.0|-2.3|1.48|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.48|-2.30|0.7224
70850229|NCT02785770|141188257|SUPERIORITY_OR_OTHER||LS mean difference|0.52||||0.6507|TWO_SIDED|90.0|-1.37|2.41|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||2.41|-1.37|0.6507
70850230|NCT02785770|141188257|SUPERIORITY_OR_OTHER||LS mean difference|-1.72||||0.1366|TWO_SIDED|90.0|-3.62|0.18|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.18|-3.62|0.1366
70850231|NCT02785770|141188257|SUPERIORITY_OR_OTHER||LS mean difference|-2.81||||0.0153|TWO_SIDED|90.0|-4.71|-0.91|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.91|-4.71|0.0153
70850232|NCT02785770|141188257|SUPERIORITY_OR_OTHER||LS mean difference|-1.88||||0.104|TWO_SIDED|90.0|-3.78|0.02|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.02|-3.78|0.1040
70850233|NCT02785770|141188257|SUPERIORITY_OR_OTHER||LS mean difference|-1.51||||0.1924|TWO_SIDED|90.0|-3.41|0.4|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.40|-3.41|0.1924
70850234|NCT02785770|141188257|SUPERIORITY_OR_OTHER||LS mean difference|-1.94||||0.0928|TWO_SIDED|90.0|-3.84|-0.04|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.04|-3.84|0.0928
70850235|NCT02785770|141188257|SUPERIORITY_OR_OTHER||LS mean difference|-2.06||||0.0745|TWO_SIDED|90.0|-3.96|-0.16|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.16|-3.96|0.0745
70850236|NCT02785770|141188257|SUPERIORITY_OR_OTHER||LS mean difference|-1.01||||0.3836|TWO_SIDED|90.0|-2.91|0.9|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.90|-2.91|0.3836
70850237|NCT02785770|141188257|SUPERIORITY_OR_OTHER||LS mean difference|-2.07||||0.0734|TWO_SIDED|90.0|-3.97|-0.17|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.17|-3.97|0.0734
70850238|NCT02785770|141188258|SUPERIORITY_OR_OTHER||LS mean difference|0.8||||0.2588|TWO_SIDED|90.0|-0.36|1.96|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.96|-0.36|0.2588
70850239|NCT02785770|141188258|SUPERIORITY_OR_OTHER||LS mean difference|0.14||||0.8465|TWO_SIDED|90.0|-1.03|1.3|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.30|-1.03|0.8465
70850240|NCT02785770|141188258|SUPERIORITY_OR_OTHER||LS mean difference|1.02||||0.1502|TWO_SIDED|90.0|-0.15|2.18|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||2.18|-0.15|0.1502
70850241|NCT02785770|141188258|SUPERIORITY_OR_OTHER||LS mean difference|-0.03||||0.97|TWO_SIDED|90.0|-1.19|1.14|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.14|-1.19|0.9700
70850242|NCT02785770|141188258|SUPERIORITY_OR_OTHER||LS mean difference|-1.18||||0.0947|TWO_SIDED|90.0|-2.34|-0.02|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.02|-2.34|0.0947
71092042|NCT02320396|141690695|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.19|||<|0.001|TWO_SIDED|95.0|-0.3|-0.09|||cLDA model|||"Change from BL to Week 2 in Interference with Daily Activities: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Interference with Daily Activities was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.09|-0.30|<0.001
71092043|NCT02320396|141690695|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.17|||<|0.001|TWO_SIDED|95.0|-0.26|-0.08|||cLDA model|||"Change from BL in Interference with Daily Activities During 2 Wks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Interference with Daily Activities estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1-Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo evaluated with the 95% confidence interval and P-value."||-0.08|-0.26|<0.001
71092044|NCT02320396|141690696|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.492||||0.071|TWO_SIDED|95.0|0.966|2.303|||Regression, Logistic|||"Impression Rate as Assessed by Investigator: Desloratadine 5 mg/Placebo Odds Ratio~Impression was evaluated using a logistic model with impression rate (percentage of assessments of Better + Much better) as a response variable and treatment and severity as factors. Odds ratio was estimated and tested. A point estimate of \>1 indicated that desloratadine 5mg was more effective than placebo."||2.303|0.966|0.071
71092045|NCT02320396|141690697|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.149|||<|0.001|TWO_SIDED|95.0|1.408|3.28|||Regression, Logistic|||"Impression Rate as Assessed by Participant: Desloratadine 5 mg/Placebo Odds Ratio~Impression was evaluated using a logistic model with impression rate (percentage of assessments of Better + Much better) as a response variable and treatment and severity as factors. Odds ratio was estimated and tested. A point estimate of \>1 indicated that desloratadine 5mg was more effective than placebo"||3.280|1.408|<0.001
71092046|NCT03331562|141690698|SUPERIORITY||Risk Ratio (RR)|0.0||||0.31|ONE_SIDED|95.0|0.0||||Fisher Exact||Lower bound cannot be estimated because there were 0 events in the comparison group.||||0|.31
71092047|NCT01719653|141690726|OTHER||||||<|0.005||||||Chicago BPS Total Score -- 1 was lower than 3,4,5; 2 was lower than 5. Modified Chicago BPS Total Score -- 1 were lower than 5. Chicago BPS Fluid Score -- 1 was dryer than 3,4,5; 2 was dryer than 3,4,5; 3 was wetter than 4,5.|t-test, 2 sided|||"All 5 arms were compared pair-wise.~1=G+PEG-306 2=G+PEG-357 3=G+PEG-Split 4=PEG+Asc-Split 5=SS-Split"||||<0.005
71092048|NCT01719653|141690727|OTHER||||||<|0.001||||||1 was lower than 4,5.|t-test, 2 sided|||"All 5 arms were compared pair-wise.~1=G+PEG-306 2=G+PEG-357 3=G+PEG-Split 4=PEG+Asc-Split 5=SS-Split"||||<0.001
71092049|NCT01719653|141690728|OTHER||||||>|0.005|||||||Chi-squared|||All 5 arms were compared pair-wise.||||>0.005
71092050|NCT01192178|141690736|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.971||||0.928|TWO_SIDED|95.0|0.519|1.819||Cox Proportional Hazards model adjusted for investigative center|Regression, Cox||The risk of having an asthma exacerbation during the treatment period was analyzed.|||1.819|0.519|0.928
71092051|NCT01155570|141690758|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 4||||<0.0001
71092052|NCT01155570|141690759|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 8||||<0.0001
71092053|NCT01155570|141690760|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 16||||<0.0001
71092054|NCT01155570|141690761|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 24||||<0.0001
71092055|NCT01155570|141690762|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 16||||<0.0001
71092056|NCT01155570|141690763|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 24||||<0.0001
71092057|NCT01155570|141690768|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 16||||<0.0001
70850243|NCT02785770|141188258|SUPERIORITY_OR_OTHER||LS mean difference|0.2||||0.7759|TWO_SIDED|90.0|-0.96|1.36|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.36|-0.96|0.7759
71092058|NCT01155570|141690769|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 24||||<0.0001
71092059|NCT01155570|141690770|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 4||||<0.0001
71092060|NCT01155570|141690771|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 16||||<0.0001
71092061|NCT01155570|141690773|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 24||||<0.0001
71092062|NCT01155570|141690774|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 4||||<0.0001
71092063|NCT01155570|141690775|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 16||||<0.0001
71092064|NCT01155570|141690776|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 24||||<0.0001
71092065|NCT01155570|141690777|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 4||||<0.0001
71092066|NCT01155570|141690778|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 16||||<0.0001
71092067|NCT01155570|141690779|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 24||||<0.0001
71092068|NCT00296517|141690780|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.2||||0.805||95.0|-1.6|2.0|||ANOVA|||Null Hypothesis: The population mean change from baseline on HAM-D total score at Week 12 of the placebo group is equal to the population mean change from baseline on HAMD total score at Week 12 of the Bupropion hydrochloride sustained release group.||2.0|-1.6|0.805
71092069|NCT00296517|141690790|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036|||||||Log Rank|||||||0.036
71092070|NCT03513952|141690798|SUPERIORITY|||||||0.428||||||A one-sided significance level of 0.10 will be considered for the test.|Cochran-Mantel-Haenszel||||Estimations were done separately in each treatment arm; the difference between treatments was not calculated.|||0.428
71092071|NCT03513952|141690799|EQUIVALENCE|"Two-sided Cochran-Mantel-Haenszel test for the CBR was performed, which is used for testing zero effect or equivalence between treatments. A two-sided significance level of 0.05 will be considered for the test."|Risk Difference (RD)|-6.0||||0.702|TWO_SIDED|95.0|-36.3|24.3|||Cochran-Mantel-Haenszel|||||24.3|-36.3|0.702
71092072|NCT01143324|141690811|SUPERIORITY_OR_OTHER||Mean|1.3|STANDARD_DEVIATION|0.5|||TWO_SIDED|95.0|1.2|1.3||||||||1.3|1.2|
71031470|NCT00986245|141570924|NON_INFERIORITY_OR_EQUIVALENCE|80% power|Mean Difference (Final Values)|0.1|||<|0.05|||||||Sign test|||"The Epworth sleep scale was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test."||||<0.05
71031471|NCT00986245|141570925|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|||<|0.05|||||||Sign test|||||||<0.05
71031472|NCT01629381|141570932|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-5.3||||0.03|TWO_SIDED|95.0|-11.3|-0.4|||Fisher Exact|||||-0.4|-11.3|0.03
71031473|NCT01629381|141570934|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-5.3||||0.03|TWO_SIDED|95.0|-11.7|-0.1|||Fisher Exact|||||-0.1|-11.7|0.03
71031474|NCT01629381|141570935|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-2.0||||0.53|TWO_SIDED|95.0|-8.0|3.7|||Fisher Exact|||||3.7|-8.0|0.53
71031475|NCT01214850|141570936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.185||||0.3828|TWO_SIDED|95.0|0.809|1.737|||Regression, Logistic|||Vaccine Group Odds Ratios for carriage of virulent ST strain of N. meningitidis group B in 4CMenB group as compared to the control group at 1 month after receiving the 2nd rMenB+OMV NZ vaccination||1.737|0.809|0.3828
71031476|NCT01214850|141570937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.555|1.273|||Regression, Logistic|||Vaccine Group Odds Ratios for carriage of combined N. meningitidis serogroups A, C, W, Y in the MenACWY-CRM group compared to Control group at 1 month after receiving 1 injection of MenACWY vaccine||1.273|0.555|
71031477|NCT00854308|141570974|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.086||||0.6873|TWO_SIDED|95.0|0.727|1.622|||Log Rank||The hazard ratio was estimated using Cox Regression and was stratified for smoking status, Eastern Cooperative Oncology Group (ECOG) performance status and histology. The hazard ratio is relative to Placebo + Erlotinib.|The null hypothesis is that there is no difference in PFS between MetMab + Erlotinib and Placebo + Erlotinib. The alternate hypothesis is that MetMab + Erlotinib would have prolonged PFS compared with Placebo + Erlotinib.||1.622|0.727|0.6873
71031478|NCT00854308|141570975|SUPERIORITY_OR_OTHER|||||||0.7101||95.0||||P-value was stratified for smoking status, ECOG performance status and histology.|Cochran-Mantel-Haenszel|||The null hypothesis is that there is no difference in Objective Response between MetMab + Erlotinib and Placebo + Erlotinib. The alternate hypothesis is that MetMab + Erlotinib would have better Objective Response compared with Placebo + Erlotinib.||||0.7101
71031479|NCT00854308|141570976|SUPERIORITY_OR_OTHER|||||||0.3671||95.0||||P-value was stratified for smoking status, ECOG performance status and histology.|Cochran-Mantel-Haenszel|||The null hypothesis is that there is no difference in Objective Response between MetMab + Erlotinib and Placebo + Erlotinib. The alternate hypothesis is that MetMab + Erlotinib would have better Objective Response compared with Placebo + Erlotinib||||0.3671
71031480|NCT00854308|141570977|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.529||||0.0418|TWO_SIDED|95.0|0.284|0.986|||Log Rank||The hazard ratio was estimated using Cox Regression and was stratified for smoking status, ECOG performance status and histology. The hazard ratio is relative to Placebo + Erlotinib.|The null hypothesis is that there is no difference in PFS between MetMab + Erlotinib and Placebo + Erlotinib. The alternate hypothesis is that MetMab + Erlotinib would have prolonged PFS compared with Placebo + Erlotinib.||0.986|0.284|0.0418
71031481|NCT03252353|141571024|SUPERIORITY|||||||0.0079|||||||Regression, Logistic|The adjusted proportion of responders is 58.16 for Octreotide Capsule Treatment Group vs. 19.42 for the Placebo||The proportion of \[IGF-1/GH\] responders was compared between treatment groups using an exact logistic regression model with categorical covariates for treatment group, prior SRL dose, and baseline \[IGF-1/GH\] level||||0.0079
71031482|NCT03252353|141571025|SUPERIORITY|||||||0.0007|||||||Regression, Logistic|The adjusted proportion of responders is 77.66 for Octreotide Capsule Treatment Group vs. 30.40 for the Placebo||The proportion of \[IGF-1/GH\] responders was compared between treatment groups using an exact logistic regression model with categorical covariates for treatment group, prior SRL dose, and baseline \[IGF-1/GH\] level||||0.0007
71031483|NCT03252353|141571026|SUPERIORITY|||||||0.0029|||||||Fisher Exact|||||||0.0029
71031484|NCT00048581|141571032|SUPERIORITY_OR_OTHER||Est. Weighted. Diff: Day 169 ACR 20|30.8|||<|0.001|TWO_SIDED|95.0|20.6|41.1||The a priori threshold for statistical significance was 5%. ACR 20 RR at 6 mos for PLA was expected to be \~25%. A sample of 256 in the ABA arm and 128 in PLA arm will yield a 96% power to detect a difference of 20% in ACR 20 at 5% significance level.|Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|The first coprimary endpoint efficacy analysis tested for differences in ACR 20 response rate (RR) between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving placebo plus background DMARDs on Day 169. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||41.1|20.6|<0.001
71092073|NCT01143324|141690812|SUPERIORITY_OR_OTHER||Difference from pre-op mean|-3.3|||<|0.0001|TWO_SIDED|95.0|-3.6|-2.9|||t-test, 2 sided|||||-2.9|-3.6|<0.0001
71092074|NCT01143324|141690813|SUPERIORITY_OR_OTHER||Difference from pre-op mean|-3.8|||<|0.0001|TWO_SIDED|95.0|-4.2|-3.3|||t-test, 2 sided|||||-3.3|-4.2|<0.0001
71092075|NCT01143324|141690814|SUPERIORITY_OR_OTHER||Difference from pre-op mean|0.35|||<|0.0001|TWO_SIDED|95.0|0.3|0.41|||t-test, 2 sided|||||0.41|0.30|<0.0001
71092076|NCT01143324|141690816|SUPERIORITY_OR_OTHER||Percentage|27.0|||||||||||||61/226 patients underwent a rehabilitation programs between 6 and 12 months follow up visit, making it 27.0 % of the total.|||||
71092077|NCT01143324|141690817|SUPERIORITY_OR_OTHER||Percentage|1.2|||||||||||||The rate of additional lumbar spinal surgeries at treated level was 1.2% (3/252) patients.|||||
71092078|NCT01143324|141690818|SUPERIORITY_OR_OTHER||Percentage|1.6|||||||||||||The rate of additional lumbar spinal surgeries at the same level was 1.6% (4/252) patients.|||||
71092079|NCT01143324|141690819|SUPERIORITY_OR_OTHER||Percentage at 12 months|47.6||||||||||||||||||
71092080|NCT01143324|141690821|SUPERIORITY_OR_OTHER||Difference from pre-op mean|-23.0|||<|0.0001|TWO_SIDED|95.0|-25.5|-20.5|||t-test, 2 sided|||||-20.5|-25.5|<0.0001
71092081|NCT01143324|141690822|SUPERIORITY_OR_OTHER||Percentage|42.7||||||||||||||||||
71092082|NCT01143324|141690823|SUPERIORITY_OR_OTHER||Mean|3.2|STANDARD_DEVIATION|2.0||||95.0|2.9|3.4||||||||3.4|2.9|
71092083|NCT01101178|141690839|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|110.0|||||TWO_SIDED|90.0|105.21|114.47|||ANOVA||Bioequivalence was established when 90% Confidence Interval fell within 80%-125%.|||114.47|105.21|
71092084|NCT01101178|141690840|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|94.7|||||TWO_SIDED|90.0|92.71|96.64|||ANOVA||Bioequivalence was established when 90% Confidence Interval fell within 80%-125%.|||96.64|92.71|
71092085|NCT01101178|141690841|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|94.9|||||TWO_SIDED|90.0|92.9|97.02|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||97.02|92.90|
71092086|NCT02774889|141690873|SUPERIORITY||Rate Ratio|0.72||||0.55|TWO_SIDED|95.0|0.27|2.57|||Fisher Exact|||||2.57|0.27|0.55
71092087|NCT02774889|141690874|SUPERIORITY||Mean Difference (Final Values)|-4.74||||0.001|TWO_SIDED|95.0|-6.61|-2.89|||Fisher Exact|||at 3 months||-2.89|-6.61|0.001
71092088|NCT02774889|141690874|SUPERIORITY||Mean Difference (Final Values)|-4.07||||0.001|TWO_SIDED|95.0|-6.47|-1.68|||Fisher Exact|||at 6 months||-1.68|-6.47|0.001
71092089|NCT02774889|141690875|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.05|TWO_SIDED|95.0|0.0|0.16|||Fisher Exact|||3 months||0.16|0.00|0.05
71092090|NCT02774889|141690875|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.0003|TWO_SIDED|95.0|0.07|0.22|||Fisher Exact|||6 months||0.22|0.07|0.0003
71092091|NCT02774889|141690876|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.88|TWO_SIDED|95.0|-0.4|0.44|||Fisher Exact|||3 months||0.44|-0.40|0.88
71092092|NCT02774889|141690876|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.83|TWO_SIDED|95.0|-0.48|0.37|||Fisher Exact|||6 months||0.37|-0.48|0.83
71092093|NCT02774889|141690877|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.36|TWO_SIDED|95.0|-0.2|0.54|||Fisher Exact|||3 months||0.54|-0.20|0.36
71092094|NCT02774889|141690877|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.14|TWO_SIDED|95.0|-0.11|0.77|||Fisher Exact|||6 months||0.77|-0.11|0.14
71092095|NCT02774889|141690878|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.52|TWO_SIDED|95.0|-0.43|0.85|||Fisher Exact|||3 months||0.85|-0.43|0.52
71092096|NCT02774889|141690878|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.36|TWO_SIDED|95.0|-0.31|0.85|||Fisher Exact|||6 months||0.85|-0.31|0.36
71092097|NCT02774889|141690879|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.43|TWO_SIDED|95.0|-0.58|1.32|||Fisher Exact|||3 months||1.32|-0.58|0.43
71092098|NCT02774889|141690879|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.26|TWO_SIDED|95.0|-0.42|1.49|||Fisher Exact|||6 months||1.49|-0.42|0.26
71092099|NCT02774889|141690880|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.16|TWO_SIDED|95.0|-0.09|0.61|||Fisher Exact|||3 months||0.61|-0.09|0.16
71092100|NCT02774889|141690880|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.29|TWO_SIDED|95.0|-0.55|0.17|||Fisher Exact|||6 months||0.17|-0.55|0.29
71092101|NCT02774889|141690882|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.91|TWO_SIDED|95.0|-2.66|2.4|||Fisher Exact|||3 months||2.40|-2.66|0.91
71092102|NCT02774889|141690882|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.8|TWO_SIDED|95.0|-2.79|2.15|||Fisher Exact|||6 months||2.15|-2.79|0.80
71092103|NCT02774889|141690883|SUPERIORITY||Mean Difference (Final Values)|0.63||||0.54|TWO_SIDED|95.0|-1.44|2.64|||Fisher Exact|||3 months||2.64|-1.44|0.54
71092104|NCT02774889|141690883|SUPERIORITY||Mean Difference (Final Values)|1.18||||0.38|TWO_SIDED|95.0|-1.49|3.81|||Fisher Exact|||6 months||3.81|-1.49|0.38
71092105|NCT02774889|141690885|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.04|TWO_SIDED|95.0|0.06|3.71|||Fisher Exact|||Inside Balance||3.71|0.06|0.04
71092106|NCT02774889|141690885|SUPERIORITY||Mean Difference (Final Values)|1.75||||0.05|TWO_SIDED|95.0|-0.02|3.51|||Fisher Exact|||Outside Balance||3.51|-0.02|0.05
71092107|NCT02774889|141690885|SUPERIORITY||Mean Difference (Final Values)|1.86||||0.06|TWO_SIDED|95.0|-0.08|3.81|||Fisher Exact|||Strength||3.81|-0.08|0.06
71092108|NCT02774889|141690886|SUPERIORITY||Mean Difference (Final Values)|1.63||||0.003|TWO_SIDED|95.0|0.54|2.17|||Fisher Exact|||Balance Exercises at 3 months||2.17|0.54|0.003
71092109|NCT02774889|141690886|SUPERIORITY||Mean Difference (Final Values)|1.01||||0.11|TWO_SIDED|95.0|-0.22|2.24|||Fisher Exact|||Balance Exercises at 6 Months||2.24|-0.22|0.11
71092110|NCT02774889|141690887|SUPERIORITY||Mean Difference (Final Values)|1.06||||0.01|TWO_SIDED|95.0|0.23|1.89|||Fisher Exact|||Strength Exercises at 3 months||1.89|0.23|0.01
71092111|NCT02774889|141690887|SUPERIORITY||Mean Difference (Final Values)|0.75||||0.11|TWO_SIDED|95.0|-0.16|1.67|||Fisher Exact|||Strength Exercises at 6 months||1.67|-0.16|0.11
71092112|NCT02774889|141690888|SUPERIORITY||Mean Difference (Final Values)|1.02||||0.38|TWO_SIDED|95.0|-1.3|3.3|||Fisher Exact|||3 months||3.30|-1.30|0.38
71092113|NCT02774889|141690888|SUPERIORITY||Mean Difference (Final Values)|2.6||||0.02|TWO_SIDED|95.0|0.43|4.73|||Fisher Exact|||6 months||4.73|0.43|0.02
71092114|NCT02774889|141690889|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.33|TWO_SIDED|95.0|-0.33|0.97|||Fisher Exact|||3 months||0.97|-0.33|0.33
71092115|NCT02774889|141690889|SUPERIORITY||Mean Difference (Final Values)|0.63||||0.06|TWO_SIDED|95.0|-0.02|1.27|||Fisher Exact|||6 months||1.27|-0.02|0.06
71092116|NCT02774889|141690890|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.06|TWO_SIDED|95.0|-0.03|1.28|||Fisher Exact|||3 months||1.28|-0.03|0.06
71092117|NCT02774889|141690890|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.59|TWO_SIDED|95.0|-0.45|0.81|||Fisher Exact|||||0.81|-0.45|0.59
71092118|NCT04901624|141690922|SUPERIORITY||Slope|1.19|STANDARD_ERROR_OF_MEAN|0.4||0.003|TWO_SIDED|95.0|0.42|1.97|||Mixed Models Analysis||Coefficient for mixed effects regression comparing Time 2 attendance to Time 1 attendance for Personal + Loss Protection relative to reference group (Personal + Lottery).|||1.97|0.42|0.003
71092119|NCT04901624|141690922|SUPERIORITY||Slope|1.46|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|0.68|2.24|||Mixed Models Analysis||Coefficient for mixed effects regression comparing Time 2 attendance to Time 1 attendance for Family + Loss Protection relative to reference group (Personal + Lottery).|||2.24|0.68|<0.001
71092120|NCT04901624|141690922|SUPERIORITY||Slope|1.11|STANDARD_ERROR_OF_MEAN|0.44||0.01|TWO_SIDED|95.0|0.26|1.96|||Mixed Models Analysis||Coefficient for mixed effects regression comparing Time 2 attendance to Time 1 attendance for Family + Lottery relative to reference group (Personal + Lottery).|||1.96|0.26|0.01
71092121|NCT04901624|141690923|SUPERIORITY||Slope|-0.29|STANDARD_ERROR_OF_MEAN|0.35||0.409|TWO_SIDED|95.0|-0.98|0.4|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who indicated that money was the biggest barrier to getting the vaccine.||0.4|-0.98|0.409
71092122|NCT04901624|141690923|SUPERIORITY||Slope|0.5|STANDARD_ERROR_OF_MEAN|0.3||0.098|TWO_SIDED|95.0|-0.09|1.1|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who indicated that money was the biggest barrier to getting the vaccine.||1.10|-0.09|0.098
71092123|NCT04901624|141690923|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.37||0.982|TWO_SIDED|95.0|-0.71|0.73|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who indicated that money was the biggest barrier to getting the vaccine.||0.73|-0.71|0.982
71092124|NCT04901624|141690923|SUPERIORITY||Slope|-0.27|STANDARD_ERROR_OF_MEAN|0.2||0.177|TWO_SIDED|95.0|-0.67|0.12|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who indicated that their medical provider was the most trusted source of COVID-19 information.||0.12|-0.67|0.177
71092125|NCT04901624|141690923|SUPERIORITY||Slope|0.33|STANDARD_ERROR_OF_MEAN|0.21||0.117|TWO_SIDED|95.0|-0.08|0.74|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who indicated that their medical provider was the most trusted source of COVID-19 information.||0.74|-0.08|0.117
71092126|NCT04901624|141690923|SUPERIORITY||Slope|0.05|STANDARD_ERROR_OF_MEAN|0.23||0.809|TWO_SIDED|95.0|-0.39|0.5|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who indicated that their medical provider was the most trusted source of COVID-19 information.||0.50|-0.39|0.809
71092127|NCT04901624|141690923|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.19||0.847|TWO_SIDED|95.0|-0.34|0.41|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who scored below or equal to 5 on the risk aversion scale (scale of 0-10, with 0 being more risk averse and 10 being more risk prone).||0.41|-0.34|0.847
71092128|NCT04901624|141690923|SUPERIORITY||Slope|-0.002|STANDARD_ERROR_OF_MEAN|0.2||0.993|TWO_SIDED|95.0|-0.39|0.38|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who scored below or equal to 5 on the risk aversion scale (scale of 0-10, with 0 being more risk averse and 10 being more risk prone).||0.38|-0.39|0.993
71092129|NCT04901624|141690923|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.22||0.671|TWO_SIDED|95.0|-0.51|0.33|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who scored below or equal to 5 on the risk aversion scale (scale of 0-10, with 0 being more risk averse and 10 being more risk prone).||0.33|-0.51|0.671
71092130|NCT00614393|141690942|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.41||||0.06|TWO_SIDED|95.0|0.99|2.0|||Regression, Cox|||||2.00|0.99|0.06
71092131|NCT00614393|141690942|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26||||0.18|TWO_SIDED|95.0|0.89|1.79|||Regression, Cox|||||1.79|0.89|0.18
71092132|NCT00614393|141690943|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.33||||0.07|TWO_SIDED|95.0|0.98|1.83|||Regression, Cox|||||1.83|0.98|0.07
71092133|NCT00614393|141690943|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.44|TWO_SIDED|95.0|0.83|1.55|||Regression, Cox|||||1.55|0.83|0.44
71092134|NCT02328105|141690949|SUPERIORITY|Assuming the true overall response rate is 0.20 under the null hypothesis, then this design will provide 81% power to detect a difference of 0.15 under the alternative hypothesis, assuming a one-sided alpha = 0.09 significance level. A three stage design with n=15, 30 and 45 subjects was determined with the following rejection regions: For n = 15, the rejection region in number of responses (CR or PR) is 0 - 2, for n = 30 it is 3 - 6, and for n = 45 it is 7 - 12.|Response Rate|0.364||||0.161|TWO_SIDED|95.0|0.109|0.692||This p-value is only based on partial enrollment of stage 1. As enrollment was halted early, this p-value is descriptive in nature and cannot determine the success/failure of the trial.|Fisher Exact||Confidence interval estimated using the Clopper Pearson method.|||0.692|0.109|0.161
71092135|NCT02328105|141690950|OTHER|Estimation only.|Disease Control Rate|0.818|||||TWO_SIDED|95.0|0.482|0.977|||||Confidence interval estimated using the Clopper Pearson method.|||0.977|0.482|
71092136|NCT02328105|141690951|OTHER|Estimation only.|Median|7.3|||||TWO_SIDED|95.0|2.2|13.0|||||The Kaplan Meier method was used to estimate the median PFS(in months) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||13.0|2.2|
71092137|NCT02328105|141690952|OTHER|Estimation only.|Median|30.0|||||TWO_SIDED|95.0|2.2||Upper limit of the confidence interval is not reached due to censoring rate.||||The Kaplan Meier method was used to estimate median OS(in months). The Greenwood method was used to estimate confidence limits of median overall survival.||||2.2|
71092138|NCT02328105|141690953|OTHER|Estimation only.|Median|10.8|||||TWO_SIDED|95.0|4.9|11.9|||||The Kaplan Meier method was used to estimate median duration of response (in months). The Greenwood method was used to estimate confidence limits of median duration of response.|||11.9|4.9|
71092139|NCT02328105|141690954|OTHER|Estimation only.|Median|7.3|||||TWO_SIDED|95.0|3.0|13.0|||||The Kaplan Meier method was used to estimate median duration of disease control (in months). The Greenwood method was used to estimate confidence limits of median disease control duration.|||13.0|3.0|
71092140|NCT00855582|141690955|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.3|STANDARD_ERROR_OF_MEAN|0.58|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0271 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71092141|NCT00855582|141690956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|0.66|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0271 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
70910345|NCT01167023|141309736|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.56||||0.244||95.0||||Average pain intensity was analyzed using an analysis of covariance (ANCOVA) model, with baseline intensity, treatment group and stratification variable sickle-cell genotype as explanatory variables.|ANCOVA||Least Squares (LS) Mean Difference is for 5 mg prasugrel minus placebo.|||||0.244
70910346|NCT01167023|141309737|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-128.3|||<|0.001||95.0||||A mixed-effects model repeated measures analysis with baseline measurement, stratification variable sickle cell genotype, treatment, time and time\*treatment interaction as fixed effects, and participant as a random effect in the model.|Mixed Models Analysis||Least Squares (LS) Mean Difference is for 5 mg prasugrel minus placebo.|||||<0.001
70910347|NCT00410384|141309738|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.54||||0.0167|TWO_SIDED|95.0|1.08|2.19||For the primary analysis of the primary efficacy endpoint, a step-down sequential testing procedure was used to control the type 1 error.|Regression, Logistic|Adjusted for baseline stratification factors (SELENA SLEDAI Score: ≤9 vs ≥10; proteinuria: \<2g vs ≥2g per 24hr; Race: African/indig-American vs Other)||||2.19|1.08|0.0167
70910348|NCT00410384|141309738|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.0889|TWO_SIDED|95.0|0.95|1.94||After superiority of 10 mg/kg vs placebo was established, the 1 mg/kg group was tested vs placebo (2-sided alpha=0.05)|Regression, Logistic|Adjusted for baseline stratification factors.||||1.94|0.95|0.0889
70910349|NCT00410384|141309739|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.1323|TWO_SIDED|95.0|0.92|1.87|||Regression, Logistic|Analysis was adjusted for baseline stratification factors.||||1.87|0.92|0.1323
70910350|NCT00410384|141309739|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.105|TWO_SIDED|95.0|0.94|1.91|||Regression, Logistic||Analysis was adjusted for baseline stratification factors.|||1.91|0.94|0.1050
70910351|NCT00410384|141309740|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63||||0.0063|TWO_SIDED|95.0|1.15|2.32|||Regression, Logistic|Adjusted for baseline stratification factors.||||2.32|1.15|0.0063
70910352|NCT00410384|141309740|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.074|TWO_SIDED|95.0|0.97|1.96|||Regression, Logistic|Adjusted for baseline stratification factors.||||1.96|0.97|0.0740
71092142|NCT00855582|141690957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.59||0.181||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0271 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.181
70910353|NCT00410384|141309741|SUPERIORITY_OR_OTHER|||||||0.7962|||||||ANCOVA|Adjusted for baseline PGA and baseline stratification factors.||||||0.7962
70910354|NCT00410384|141309741|SUPERIORITY_OR_OTHER|||||||0.9703|||||||ANCOVA|Adjusted for baseline PGA and baseline stratification factors.||||||0.9703
70970492|NCT02706873|141446968|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|11.6|||<|0.001|TWO_SIDED|95.0|5.4|17.8||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||17.8|5.4|<0.001
70910355|NCT00410384|141309742|SUPERIORITY_OR_OTHER|||||||0.6583|||||||ANCOVA|Analysis adjusted for baseline PCS and baseline stratification factors.||||||0.6583
70970493|NCT02706873|141446969|SUPERIORITY||Response Rate Difference|18.5|||<|0.001|TWO_SIDED|95.0|12.1|24.9||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||24.9|12.1|<0.001
70910356|NCT00410384|141309742|SUPERIORITY_OR_OTHER|||||||0.3762|||||||ANCOVA|Analysis adjusted for baseline PCS and baseline stratification factors.||||||0.3762
70910357|NCT00410384|141309743|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.4253|TWO_SIDED|95.0|0.65|2.74|||Regression, Logistic|Analysis was adjusted for baseline prednisone dose and baseline stratification factors.||||2.74|0.65|0.4253
70910358|NCT00410384|141309743|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.2081|TWO_SIDED|95.0|0.78|3.13|||Regression, Logistic|Analysis was adjusted for baseline prednisone dose and baseline stratification factors.||||3.13|0.78|0.2081
70910359|NCT02049437|141309747|SUPERIORITY||Risk Ratio (RR)|4.43||||0.07|TWO_SIDED|95.0|0.9|21.83|||Mixed Models Analysis|||||21.83|0.90|0.07
70910360|NCT02049437|141309748|SUPERIORITY||Mean Difference (Final Values)|-2036.8|||<|0.001|TWO_SIDED|95.0|-3490.32|-900.62|||Wilcoxon (Mann-Whitney)|||||-900.62|-3490.32|<0.001
70910361|NCT02049437|141309749|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.77|TWO_SIDED|95.0|-0.79|0.65|||Wilcoxon (Mann-Whitney)|||||0.65|-0.79|0.77
70910362|NCT03682536|141309804|SUPERIORITY||Odds Ratio (OR)|3.1|||<|0.0001|TWO_SIDED|95.0|2.0|4.8|||Cochran-Mantel-Haenszel|||||4.8|2.0|<.0001
70910363|NCT03682536|141309805|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0003|TWO_SIDED|95.0|1.4|3.7|||Cochran-Mantel-Haenszel|||||3.7|1.4|0.0003
70910364|NCT03682536|141309807|SUPERIORITY||Odds Ratio (OR)|2.8|||<|0.0001|TWO_SIDED|95.0|1.8|4.5|||Cochran-Mantel-Haenszel|||||4.5|1.8|<.0001
70910365|NCT03682536|141309809|SUPERIORITY||Odds Ratio (OR)|2.5|||<|0.0001|TWO_SIDED|95.0|1.6|4.0|||Cochran-Mantel-Haenszel|||||4.0|1.6|<.0001
70910366|NCT03682536|141309810|SUPERIORITY||Hazard Ratio (HR)|0.534||||0.0096|TWO_SIDED|95.0|0.33|0.864|||Log Rank||Calculated by Cox proportional hazard model|||0.864|0.330|0.0096
70910367|NCT03682536|141309814|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0007|TWO_SIDED|95.0|1.4|3.8|||Cochran-Mantel-Haenszel|||||3.8|1.4|0.0007
70910368|NCT03682536|141309815|SUPERIORITY||Odds Ratio (OR)|2.6|||<|0.0001|TWO_SIDED|95.0|1.6|4.3|||Cochran-Mantel-Haenszel|||||4.3|1.6|<.0001
70910369|NCT03298815|141309832|SUPERIORITY|||||||0.375|||||||McNemar|||||||0.375
70910370|NCT03298815|141309833|SUPERIORITY|||||||0.391|||||||Wilcoxon (Mann-Whitney)|||||||0.391
70910371|NCT03298815|141309834|SUPERIORITY|||||||0.267|||||||Wilcoxon (Mann-Whitney)|||||||0.267
70910372|NCT03298815|141309835|SUPERIORITY|||||||0.445|||||||Wilcoxon (Mann-Whitney)|||||||0.445
70910373|NCT03298815|141309836|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.250
71031485|NCT00048581|141571033|SUPERIORITY_OR_OTHER||Est. of Weighted Diff: Day 169 HAQ|24.0|||<|0.001|TWO_SIDED|95.0|13.8|34.2||If the ACR20 analysis was not significant (5% level), then the comparison for HAQ response was not undertaken. If ACR20 comparison was significant (5% level), then CMH Chi-square test compared HAQ response between groups (5% level).|Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|All comparisons of changes from baseline and construction of confidence intervals for continuous measures were based on an ANCOVA model with treatment as the main factor and baseline value as covariate.|The two primary efficacy analyses tested first for differences in ACR 20 followed by testing HAQ response rates between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs on Day 169. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||34.2|13.8|<0.001
70910374|NCT03298815|141309837|SUPERIORITY||||||<|1|||||||Wilcoxon (Mann-Whitney)|||||||<1.00
70910375|NCT03298815|141309838|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.500
70910376|NCT03298815|141309839|SUPERIORITY|||||||0.563|||||||Wilcoxon (Mann-Whitney)|||||||0.563
70910377|NCT03298815|141309840|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
70910378|NCT03298815|141309841|SUPERIORITY|||||||0.156|||||||Wilcoxon (Mann-Whitney)|||||||0.156
71031486|NCT00048581|141571034|SUPERIORITY_OR_OTHER||Est. of Diff: Day 15 ACR 20|12.3||||0.001|TWO_SIDED|95.0|4.6|20.0|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||20.0|4.6|0.001
71031487|NCT00048581|141571034|SUPERIORITY_OR_OTHER||Est. of Diff: Day 15 ACR 50|2.3||||0.001|TWO_SIDED|95.0|-0.8|5.5|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||5.5|-0.8|0.001
71031488|NCT00048581|141571034|SUPERIORITY_OR_OTHER||Est. of Diff: Day 15 ACR 70|0.8||||0.784|TWO_SIDED|95.0|-1.3|2.9|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||2.9|-1.3|0.784
71031489|NCT00048581|141571034|SUPERIORITY_OR_OTHER||Est. of Diff: Day 29 ACR 20|14.0||||0.005|TWO_SIDED|95.0|4.0|24.0|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||24.0|4.0|0.005
71031490|NCT00048581|141571034|SUPERIORITY_OR_OTHER||Est. of Diff: Day 29 ACR 50|5.6||||0.06|TWO_SIDED|95.0|-0.2|11.4|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||11.4|-0.2|0.06
71031491|NCT00048581|141571034|SUPERIORITY_OR_OTHER||Est. of Diff: Day 29 ACR 70|1.6||||0.473|TWO_SIDED|95.0|-1.8|4.9|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||4.9|-1.8|0.473
71031492|NCT00048581|141571034|SUPERIORITY_OR_OTHER||Est. of Diff: Day 57 ACR 20|22.0|||<|0.001|TWO_SIDED|95.0|11.3|32.8|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||32.8|11.3|<0.001
71031493|NCT00048581|141571034|SUPERIORITY_OR_OTHER||Est. of Diff: Day 57 ACR 50|6.5||||0.076|TWO_SIDED|95.0|-0.6|13.7|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||13.7|-0.6|0.076
70910379|NCT03298815|141309842|SUPERIORITY|||||||0.208|||||||Wilcoxon (Mann-Whitney)|||||||0.208
70910380|NCT03298815|141309843|SUPERIORITY|||||||0.594||||||30 day visit|Wilcoxon (Mann-Whitney)|||||||0.594
70910381|NCT03298815|141309843|SUPERIORITY|||||||0.469||||||60 day visit|Wilcoxon (Mann-Whitney)|||||||0.469
70910382|NCT03298815|141309843|SUPERIORITY|||||||0.75||||||100 day visit|Wilcoxon (Mann-Whitney)|||||||0.750
70910383|NCT03298815|141309844|SUPERIORITY|||||||0.063||||||30 day visit|Wilcoxon (Mann-Whitney)|||||||0.063
70910384|NCT03298815|141309844|SUPERIORITY||||||<|1||||||60 day visit|Wilcoxon (Mann-Whitney)|||||||<1.000
70910385|NCT03298815|141309844|SUPERIORITY|||||||0.25||||||100 day visit|Wilcoxon (Mann-Whitney)|||||||0.250
70910386|NCT02507219|141309857|SUPERIORITY||Slope|0.000055||||0.512|TWO_SIDED|95.0|-0.00011|0.00022|||Mixed Models Analysis||Slope is percent signal change per milligram of ibuprofen.|A linear mixed effects model was run for the left amygdala with contrast and percent signal change between faces and shapes as the dependent variable and ibuprofen dose as a continuous predictor. Each subject had up to 3 visits and each visit contained 3 contrasts (happy - shape, angry - shape, fearful - shape) so subject and drug were used as random effects. Drug was nested inside of subject.||0.00022|-0.00011|0.512
70910387|NCT02507219|141309857|SUPERIORITY||Slope|-0.00012||||0.221|TWO_SIDED|95.0|-0.0003|0.000067|||Mixed Models Analysis||Slope is the percent signal change per mg of ibuprofen.|A linear mixed effects model was run for the right amygdala with contrast and percent signal change between faces and shapes as the dependent variable and ibuprofen dose as a continuous predictor. Each subject had up to 3 visits and each visit contained 3 contrasts (happy - shape, angry - shape, fearful - shape) so subject and drug were used as random effects. Drug was nested inside of subject.||0.000067|-0.00030|0.221
70910388|NCT02753530|141310031|SUPERIORITY||Least Square (LS) Mean Difference|-0.99||||0.1146|TWO_SIDED|95.0|-2.23|0.24||Primary Estimand (Treatment Policy)|Mixed Models Analysis|||The baseline observation was the last observation recorded prior to the first dose of study medication. The change from baseline in IBMFRS total score was analyzed using a Mixed Models for Repeated Measures (MMRM) with treatment interacting with visit and trial site as factors. Baseline IBMFRS total score interacting with visit was further included as covariate. An unstructured covariance matrix was assumed.||0.24|-2.23|0.1146
70910389|NCT05160025|141310051|SUPERIORITY||||||<|0.001||||||"rmANOVA \< 0.001~post hoc paired t-tests or nonparametric equivalent with correction (x3) indicated the following: self-competition \> feedback (p \< 0.001) other-competition \> feedback (p \< 0.001) self-competition = other-competition (p \> 0.05)"|ANOVA|||||||<0.001
70910390|NCT05160025|141310054|SUPERIORITY|||||||0.111||||||"rmANOVA p = 0.111~post hoc paired t-tests not performed"|ANOVA|||||||0.111
70910391|NCT05160025|141310057|SUPERIORITY||||||<|0.001||||||"rmANOVA \< 0.001~post hoc paired t-tests or nonparametric equivalent corrected (x3) indicated the following: self-competition \> feedback (p = 0.003) other-competition \> feedback (p = 0.007) self-competition = other-competition (p \> 0.05)"|ANOVA|||||||<0.001
70910392|NCT05160025|141310060|SUPERIORITY||||||>|0.05||||||"rmANOVA p \> 0.05 with a partial eta squared effect size = 0.073~post hoc paired t-tests not performed"|ANOVA|||||||> 0.05
70910393|NCT05160025|141310065|SUPERIORITY|||||||0.004||||||"rmANOVA = 0.004~post hoc paired t-tests or nonparametric equivalent corrected (x3) indicated the following: self-competition \> feedback (p = 0.007) other-competition \> feedback (p = 0.002) self-competition = other-competition (p \> 0.05)"|ANOVA|||||||0.004
70910394|NCT05160025|141310073|SUPERIORITY||||||>|0.05||||||ranking compared to expected value for each condition and the p-value was adjusted for 3 comparisons for each condition: self-competition (p \> 0.05) other-competition (p \> 0.05) feedback (p \> 0.05)|Chi-squared|||||||> 0.05
70910395|NCT05160025|141310074|SUPERIORITY||||||>|0.05||||||ranking compared to expected value for each condition and the p-value was adjusted for 3 comparisons for each condition: self-competition (p \> 0.05) other-competition (p \> 0.05) feedback (p \> 0.05)|Chi-squared|||||||> 0.05
70910396|NCT02028884|141310099|SUPERIORITY||Hazard Ratio (HR)|0.38||||0.0184|TWO_SIDED|95.0|0.16|0.88|||Log Rank|||Stratified by Baseline annualized relapse rate (ARR: 1, \> 1) and geographic region (Asia, EU/Other).||0.88|0.16|0.0184
70910397|NCT02028884|141310100|SUPERIORITY||Mean Difference (Final Values)|6.376|STANDARD_ERROR_OF_MEAN|3.344||0.0602|TWO_SIDED|95.0|-0.28|13.033|||ANCOVA|ANCOVA model: treatment group as fixed effect and baseline measurements, prior therapy, most recent attack (first attack/relapse) as covariates.||||13.033|-0.280|0.0602
70910398|NCT02028884|141310101|SUPERIORITY||Mean Difference (Final Values)|-2.089|STANDARD_ERROR_OF_MEAN|1.338||0.1224|TWO_SIDED|95.0|-4.752|0.574|||ANCOVA|ANCOVA model: treatment group as fixed effect and baseline measurements, prior therapy, most recent attack (first attack/relapse) as covariates.||||0.574|-4.752|0.1224
70910399|NCT00354029|141310130|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||||||>0.05
70910400|NCT02403674|141310135|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 95% CI of the mean treatment difference was greater than -10.|Difference in percentages|3.537|||||TWO_SIDED|95.0|-1.951|9.026|||||The 95% CIs for difference in percentages were calculated using stratum-adjusted Mantel-Haenszel method for each stratum (HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|||9.026|-1.951|
70910401|NCT02403674|141310136|SUPERIORITY|Superiority was declared when the 1-sided p-value comparing treatment difference was \<0.02497.|Difference in percentages|-28.3|||<|0.001|TWO_SIDED|95.0|-34.0|-22.5||2-sided P-value|t-test, 2 sided||95% CIs were calculated using the Miettinen and Nurminen method.|Dizziness difference||-22.5|-34.0|<0.001
70910402|NCT02403674|141310136|SUPERIORITY|Superiority was declared when the 1-sided p-value comparing treatment difference was \<0.02497.|Difference in percentages|-13.5|||<|0.001|TWO_SIDED|95.0|-19.1|-7.9||2-sided P-value|t-test, 2 sided||95% CIs were calculated using the Miettinen and Nurminen method.|Sleep disorders and disturbances difference||-7.9|-19.1|<0.001
70910403|NCT02403674|141310136|SUPERIORITY|Superiority was declared when the 1-sided p-value comparing treatment difference was \<0.02497.|Difference in percentages|-3.8||||0.033|TWO_SIDED|95.0|-7.6|-0.3||2-sided P-value|t-test, 2 sided||95% CIs were calculated using the Miettinen and Nurminen method.|Altered sensorium difference||-0.3|-7.6|0.033
70910404|NCT02403674|141310137|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 95% CI of the mean treatment difference was greater than -10|Difference in percentages|3.815|||||TWO_SIDED|95.0|-2.412|10.042|||||The 95% CIs for difference in percentages were calculated using stratum-adjusted Mantel-Haenszel method for each stratum (HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|||10.042|-2.412|
71031494|NCT00048581|141571034|SUPERIORITY_OR_OTHER||Est. of Diff: Day 57 ACR 70|5.1||||0.019|TWO_SIDED|95.0|0.7|9.4|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||9.4|0.7|0.019
71031495|NCT00048581|141571034|SUPERIORITY_OR_OTHER||Est. of Diff: Day 85 ACR 20|28.0|||<|0.001|TWO_SIDED|95.0|17.4|38.7|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||38.7|17.4|<0.001
71031496|NCT00048581|141571034|SUPERIORITY_OR_OTHER||Est. of Diff: Day 85 ACR 50|12.0||||0.002|TWO_SIDED|95.0|4.1|19.8|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||19.8|4.1|0.002
71031497|NCT00048581|141571034|SUPERIORITY_OR_OTHER||Est. of Diff: Day 85 ACR 70|5.1||||0.033|TWO_SIDED|95.0|0.4|9.8|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||9.8|0.4|0.033
71031498|NCT00048581|141571034|SUPERIORITY_OR_OTHER||Est. of Diff: Day 113 ACR 20|25.9|||<|0.001|TWO_SIDED|95.0|15.1|36.8|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)||Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||36.8|15.1|<0.001
71092143|NCT00855582|141690958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4|STANDARD_ERROR_OF_MEAN|0.67|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0271 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71092144|NCT00855582|141690959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.7|STANDARD_ERROR_OF_MEAN|2.8|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0228 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71092145|NCT00855582|141690960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.26|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0228 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71092146|NCT00855582|141690961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.5|STANDARD_ERROR_OF_MEAN|2.85|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. Based on the results of prior tests under this procedure, the statistical significance of this hypothesis was not assessed.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71092147|NCT00855582|141690962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.26||0.156||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. Based on the results of prior tests under this procedure, the statistical significance of this hypothesis was not assessed.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.156
71092148|NCT00855582|141690963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.51||0.226||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.226
70910405|NCT02403674|141310138|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 95% CI of the mean treatment difference was greater than -10.|Difference in percentages|4.1|||||TWO_SIDED|95.0|-1.5|9.7|||||The 95% CIs for difference in percentages were calculated using stratum-adjusted Mantel-Haenszel method for each stratum (HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|||9.7|-1.5|
70910406|NCT02403674|141310139|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 95% CI of the mean treatment difference was greater than -10|Difference in percentages|3.268|||||TWO_SIDED|95.0|-3.057|9.593|||||The 95% CIs for difference in percentages were calculated using stratum-adjusted Mantel-Haenszel method for each stratum (HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|||9.593|-3.057|
70910407|NCT02403674|141310140|SUPERIORITY|Superiority was declared when group difference (MK-1439A-ATRIPLA®) was a positive value.|Difference in mean %change from baseline|10.1|||||TWO_SIDED|95.0|-16.1|36.3|||||95% CIs were calculated based on t-distribution.|||36.3|-16.1|
71031499|NCT00048581|141571034|SUPERIORITY_OR_OTHER||Est. of Diff: Day 113 ACR 50|14.2|||<|0.001|TWO_SIDED|95.0|6.6|21.9|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||21.9|6.6|<0.001
71031500|NCT00048581|141571034|SUPERIORITY_OR_OTHER||Est. of Diff: Day 113 ACR 70|7.8||||0.002|TWO_SIDED|95.0|2.6|13.0|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||13.0|2.6|0.002
71031501|NCT00048581|141571034|SUPERIORITY_OR_OTHER||Est. of Diff: Day 141 ACR 20|35.5|||<|0.001|TWO_SIDED|95.0|24.6|46.5|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||46.5|24.6|<0.001
71031502|NCT00048581|141571034|SUPERIORITY_OR_OTHER||Est. of Diff: Day 141 ACR 50|20.9|||<|0.001|TWO_SIDED|95.0|12.2|29.5|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||29.5|12.2|<0.001
70910408|NCT02403674|141310141|SUPERIORITY|Superiority was declared when group difference (MK-1439A-ATRIPLA) was a positive value|Diff in mean % change from baseline|14.7|||||TWO_SIDED|95.0|-18.7|48.2|||||The 95% CI for mean difference in CD4 change was based on t-distribution.|||48.2|-18.7|
71092149|NCT00855582|141690963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.5|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
70910409|NCT02403674|141310142|OTHER|Difference in percentage of participants with ≥1 AE(s)|Difference in percentages|-8.0|||||TWO_SIDED|95.0|-13.0|-3.1|||||95% CIs were calculated with the Miettinen \& Nurminen method.|||-3.1|-13.0|
70910410|NCT02403674|141310143|OTHER|Difference in percentage of participants with ≥1 AE(s)|Difference in percentages|-3.6|||||TWO_SIDED|95.0|-6.9|-0.5|||||95% CIs were calculated with the Miettinen \& Nurminen method.|||-0.5|-6.9|
70910411|NCT02403674|141310144|SUPERIORITY|Superiority was declared when the 1-sided p-value comparing treatment difference was \<0.02497.|Difference in percentages|-2.5|||<|0.001|TWO_SIDED|95.0|-5.9|0.8||2-sided P-value|t-test, 2 sided||95% CIs were calculated using the Miettinen and Nurminen method.|Depression and suicide/self-injury difference||0.8|-5.9|<0.001
70910412|NCT02403674|141310144|SUPERIORITY|Superiority was declared when the 1-sided p-value comparing treatment difference was \<0.02497.|Difference in percentages|-0.8|||<|0.001|TWO_SIDED|95.0|-2.5|0.5||2-sided P-value|t-test, 2 sided||95% CIs were calculated using the Miettinen and Nurminen method.|Psychosis and psychotic disorders difference||0.5|-2.5|<0.001
70910413|NCT02403674|141310145|SUPERIORITY||Difference in mean %change from baseline|-10.01|||<|0.0001|TWO_SIDED|95.0|-13.53|-6.49|||ANCOVA||95% CIs and 2-sided p-values for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.|||-6.49|-13.53|<0.0001
70910414|NCT02403674|141310146|SUPERIORITY||Difference in mean %change from baseline|-17.02|||<|0.0001|TWO_SIDED|95.0|-20.89|-13.16|||ANCOVA||95% CIs and 2-sided p-values for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.|||-13.16|-20.89|<0.0001
71092150|NCT00855582|141690964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.53||0.121||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.121
70910415|NCT02403674|141310147|SUPERIORITY||Difference in mean %change from baseline|-23.44|||||TWO_SIDED|95.0|-27.57|-19.32|||||95% CIs for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.|||-19.32|-27.57|
70910416|NCT02403674|141310148|SUPERIORITY||Difference in mean %change from baseline|-35.96|||||TWO_SIDED|95.0|-47.1|-24.82|||||95% CIs for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.|||-24.82|-47.10|
70910417|NCT02403674|141310149|SUPERIORITY||Difference in mean %change from baseline|-6.47|||||TWO_SIDED|95.0|-7.97|-4.96|||||95% CIs for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.|||-4.96|-7.97|
71031503|NCT00048581|141571034|SUPERIORITY_OR_OTHER||Est. of Diff: Day 141 ACR 70|10.2|||<|0.001|TWO_SIDED|95.0|4.4|16.0|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||16.0|4.4|<0.001
71031504|NCT00048581|141571034|SUPERIORITY_OR_OTHER||Est. of Diff: Day 169 ACR 20|30.8|||<|0.001|TWO_SIDED|95.0|20.0|41.7|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||41.7|20.0|<0.001
71031505|NCT00048581|141571034|SUPERIORITY_OR_OTHER||Est. of Diff: Day 169 ACR 50|16.6|||<|0.001|TWO_SIDED|95.0|8.6|24.5|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||24.5|8.6|<0.001
71031506|NCT00048581|141571034|SUPERIORITY_OR_OTHER||Est. of Diff: Day 169 ACR 70|8.7||||0.003|TWO_SIDED|95.0|2.7|14.6|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||14.6|2.7|0.003
71031507|NCT00048581|141571055|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 PCS|3.63|||<|0.001|TWO_SIDED|95.0|1.89|5.38|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||5.38|1.89|<0.001
71031508|NCT00048581|141571055|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 MCS|2.57||||0.017|TWO_SIDED|95.0|0.47|4.67|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||4.67|0.47|0.017
71092151|NCT00855582|141690964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.57||0.169||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.169
71092152|NCT00855582|141690964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|0.52|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71092153|NCT00855582|141690964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|0.56|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71092154|NCT00855582|141690965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|0.6|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71092155|NCT00855582|141690965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|0.71|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71092156|NCT00855582|141690965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|0.59|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
70910418|NCT00826280|141310168|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value is from the primary analysis using ANCOVA.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
70910419|NCT00826280|141310168|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
70910420|NCT00826280|141310168|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
70910421|NCT00826280|141310168|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9328||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.9328
70910422|NCT00826280|141310169|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011||95.0||||P-Value is from the primary analysis using ANCOVA.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.0011
70910423|NCT00826280|141310169|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0034||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.0034
70910424|NCT00826280|141310169|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
70910425|NCT00826280|141310169|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5902||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.5902
70910426|NCT00826280|141310170|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0037||95.0||||P-Value is from the primary analysis using ANCOVA.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.0037
70910427|NCT00826280|141310170|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0089||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.0089
70910428|NCT00826280|141310170|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0016||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.0016
70910429|NCT00826280|141310170|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5654||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.5654
70910430|NCT00826280|141310171|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value is from the primary analysis using ANCOVA.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
70910431|NCT00826280|141310171|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
70910432|NCT00826280|141310171|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
70910433|NCT00826280|141310171|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4246||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||.4246
70910434|NCT01276535|141310229|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||Comparison is made of the combined application of the Erchonia MLS and the Erchonia THL. Results are analyzed at 6 weeks relative to Baseline.||||<0.01
70910435|NCT01276535|141310230|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||Comparison is made of the combined application of the Erchonia MLS and the Erchonia THL. Results are analyzed at 6 weeks relative to Baseline.||||<0.01
70910436|NCT02478359|141310339|SUPERIORITY||Odds Ratio (OR)|1.09||||0.33|TWO_SIDED|95.0|0.92|1.28|||Regression, Logistic|||||1.28|0.92|0.33
70910437|NCT02478359|141310340|SUPERIORITY||Odds Ratio (OR)|1.02||||0.88|TWO_SIDED|95.0|0.77|1.36|||Regression, Logistic|||||1.36|0.77|0.88
70910438|NCT02478359|141310341|SUPERIORITY||Odds Ratio (OR)|1.05||||0.53|TWO_SIDED|95.0|0.89|1.24|||Regression, Logistic|||||1.24|0.89|0.53
70910439|NCT02478359|141310342|SUPERIORITY||Odds Ratio (OR)|1.03||||0.73|TWO_SIDED|95.0|0.88|1.2|||Regression, Logistic|||||1.20|0.88|0.73
70910440|NCT02478359|141310343|SUPERIORITY||Odds Ratio (OR)|1.13||||0.21|TWO_SIDED|95.0|0.93|1.37|||Regression, Logistic|||||1.37|0.93|0.21
70910441|NCT02478359|141310344|SUPERIORITY||Odds Ratio (OR)|1.1||||0.26|TWO_SIDED|95.0|0.93|1.31|||Regression, Logistic|||||1.31|0.93|0.26
70910442|NCT02478359|141310345|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
70910443|NCT02478359|141310346|SUPERIORITY|||||||0.55|||||||Regression, Linear|||||||0.55
70910444|NCT02478359|141310347|SUPERIORITY|||||||0.34||||||adjusted p values|Regression, Logistic|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.34
70910445|NCT02478359|141310348|SUPERIORITY|||||||0.6|||||||Regression, Linear|||||||0.60
70910446|NCT02478359|141310349|SUPERIORITY|||||||0.32|||||||Regression, Linear|||||||0.32
70910447|NCT02478359|141310350|SUPERIORITY|||||||0.47|||||||Regression, Linear|||||||0.47
70910448|NCT02478359|141310351|SUPERIORITY|||||||0.33|||||||Regression, Linear|||||||0.33
70910449|NCT02478359|141310352|SUPERIORITY|||||||0.87||||||Adjusted P value|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.87
71031509|NCT00048581|141571055|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Physical Function|1.7||||0.052|TWO_SIDED|95.0|-0.01|3.41|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||3.41|-0.01|0.052
71031510|NCT00048581|141571055|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Role-Physical|3.01||||0.007|TWO_SIDED|95.0|0.83|5.19|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||5.19|0.83|0.007
71031511|NCT00048581|141571055|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Bodily Pain|5.62|||<|0.001|TWO_SIDED|95.0|3.77|7.47|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||7.47|3.77|<0.001
71031512|NCT00048581|141571055|SUPERIORITY_OR_OTHER||Adj Diff: General Health|2.51||||0.001|TWO_SIDED|95.0|0.99|4.02|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||4.02|0.99|0.001
71031513|NCT00048581|141571055|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Vitality|3.17||||0.001|TWO_SIDED|95.0|1.24|5.1|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||5.10|1.24|0.001
71031514|NCT00048581|141571055|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Social Functioning|4.69|||<|0.001|TWO_SIDED|95.0|2.59|6.79|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||6.79|2.59|<0.001
71031515|NCT00048581|141571055|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Role Emotional|0.97||||0.494|TWO_SIDED|95.0|-1.82|3.77|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||3.77|-1.82|0.494
71031516|NCT00048581|141571055|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Mental Health|2.59||||0.009|TWO_SIDED|95.0|0.65|4.54|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||4.54|0.65|0.009
71031517|NCT00048581|141571057|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 PCS|5.46|||<|0.001|TWO_SIDED|95.0|3.64|7.29|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||7.29|3.64|<0.001
71031518|NCT00048581|141571057|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 MCS|3.04||||0.005|TWO_SIDED|95.0|0.91|5.17|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||5.17|0.91|0.005
71031519|NCT00048581|141571057|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 Physical Function|4.03|||<|0.001|TWO_SIDED|95.0|2.08|5.98|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||5.98|2.08|<0.001
71031520|NCT00048581|141571057|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 Role-Physical|5.22|||<|0.001|TWO_SIDED|95.0|3.1|7.35|||ANCOVA|||||7.35|3.10|<0.001
71031521|NCT00048581|141571057|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 Bodily Pain|6.24|||<|0.001|TWO_SIDED|95.0|4.37|8.11|||ANCOVA|||||8.11|4.37|<0.001
71031522|NCT00048581|141571057|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 General Health|3.27|||<|0.001|TWO_SIDED|95.0|1.64|4.9|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||4.90|1.64|<0.001
71031523|NCT00048581|141571057|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 Vitality|4.78|||<|0.001|TWO_SIDED|95.0|2.76|6.79|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||6.79|2.76|<0.001
70910450|NCT02478359|141310353|SUPERIORITY|||||||0.7||||||Adjusted P value|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.70
70910451|NCT02478359|141310354|SUPERIORITY|||||||0.35|||||||Regression, Linear|Adjusted P Values||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.35
70910452|NCT02478359|141310355|SUPERIORITY|||||||0.09||||||Adjusted P Values|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.09
70910453|NCT02478359|141310356|SUPERIORITY|||||||0.82||||||Adjusted P Values|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.82
70910454|NCT02478359|141310357|SUPERIORITY|||||||0.16||||||Adjusted P values|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.16
70910455|NCT02478359|141310358|SUPERIORITY|||||||0.86||||||Adjusted P values|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.86
70910456|NCT02478359|141310359|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||||||0.57
70910457|NCT02478359|141310360|SUPERIORITY||Odds Ratio (OR)|1.05||||0.69|TWO_SIDED|95.0|0.82|1.35|||Regression, Logistic|||||1.35|0.82|0.69
70910458|NCT02478359|141310361|SUPERIORITY||Odds Ratio (OR)|0.62||||0.11|TWO_SIDED|95.0|0.35|1.11|||Regression, Logistic|||||1.11|0.35|0.11
70910459|NCT02478359|141310362|SUPERIORITY||Odds Ratio (OR)|0.84||||0.21|TWO_SIDED|95.0|0.65|1.1|||Regression, Logistic|||||1.10|0.65|0.21
70910460|NCT02478359|141310363|SUPERIORITY||Odds Ratio (OR)|1.07||||0.6|TWO_SIDED|95.0|0.84|1.36|||Regression, Logistic|||||1.36|0.84|0.60
70910461|NCT02478359|141310364|SUPERIORITY||Odds Ratio (OR)|0.92||||0.63|TWO_SIDED|95.0|0.66|1.28|||Regression, Logistic|||||1.28|0.66|0.63
70910462|NCT02478359|141310365|SUPERIORITY||Odds Ratio (OR)|0.96||||0.8|TWO_SIDED|95.0|0.68|1.35|||Regression, Logistic|||||1.35|0.68|0.80
70910463|NCT02478359|141310366|SUPERIORITY|||||||0.06||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.06
70910464|NCT02478359|141310367|SUPERIORITY|||||||0.07||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.07
70910465|NCT02478359|141310368|SUPERIORITY|||||||0.67||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.67
70910466|NCT02478359|141310369|SUPERIORITY|||||||0.13||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.13
70910467|NCT02478359|141310370|SUPERIORITY|||||||0.34||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.34
70910468|NCT02478359|141310371|SUPERIORITY|||||||0.11||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.11
70910469|NCT02478359|141310372|SUPERIORITY|||||||0.83||||||Adjusted P value|Regression, Linear|||Covariated included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.83
70910470|NCT00562965|141310373|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.19||||0.0358|TWO_SIDED|95.0|0.04|1.02|||Cox proportional hazard regression model|A 2-sided 5% significance level on a stratified Cox proportional hazard regression model was used.|In this regression model, treatment arm was the covariate and the strata (number of prior regimens, investigator's choice of therapy and geographical region) over which participants were stratified prior to randomization were the variables.|To detect a hazard ratio of 0.77 with 85% power using a 2-sided log-rank test at the 5% significance level, it was planned that approximately 978 participants were needed to be randomized but due to premature termination only 29 participants were randomized.||1.02|0.04|0.0358
70910471|NCT00562965|141310374|SUPERIORITY_OR_OTHER|||||||0.0801|TWO_SIDED||||||Fisher Exact|||||||0.0801
70970494|NCT02706873|141446969|OTHER||Response Rate Difference|22.9|||<|0.001|TWO_SIDED|95.0|16.4|29.5||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||29.5|16.4|<0.001
70970495|NCT02706873|141446970|SUPERIORITY||Response Rate Difference|20.3|||<|0.001|TWO_SIDED|95.0|13.2|27.3||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||27.3|13.2|<0.001
70970496|NCT02706873|141446970|SUPERIORITY||Response Rate Difference|19.4|||<|0.001|TWO_SIDED|95.0|12.3|26.5||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||26.5|12.3|<0.001
70970497|NCT02706873|141446971|SUPERIORITY||Response Rate Difference|26.0|||<|0.001|TWO_SIDED|95.0|19.1|33.0||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||33.0|19.1|<0.001
70970498|NCT02706873|141446971|SUPERIORITY||Response Rate Difference|31.2|||<|0.001|TWO_SIDED|95.0|24.2|38.2||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||38.2|24.2|<0.001
70970499|NCT02706873|141446972|SUPERIORITY|For the Japan sub-study, no multiplicity adjustments were applied and only nominal p-values were provided for all efficacy analyses.|Response Rate Difference|28.3||||0.004|TWO_SIDED|95.0|7.7|48.9|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||48.9|7.7|0.004
70970500|NCT02706873|141446972|SUPERIORITY||Response Rate Difference|28.0||||0.022|TWO_SIDED|95.0|5.3|50.7|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||50.7|5.3|0.022
70970501|NCT02706873|141446972|SUPERIORITY||Response Rate Difference|21.4||||0.086|TWO_SIDED|95.0|-2.4|45.2|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||45.2|-2.4|0.086
70970502|NCT02706873|141446973|SUPERIORITY||Response Rate Difference|38.6|||<|0.001|TWO_SIDED|95.0|18.6|58.5|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||58.5|18.6|<0.001
70970503|NCT02706873|141446973|SUPERIORITY||Response Rate Difference|45.2|||<|0.001|TWO_SIDED|95.0|21.8|68.6|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||68.6|21.8|<0.001
70970504|NCT02706873|141446973|SUPERIORITY||Response Rate Difference|50.0|||<|0.001|TWO_SIDED|95.0|27.4|72.6|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||72.6|27.4|<0.001
70970505|NCT02706873|141446974|SUPERIORITY||Response Rate Difference|34.5|||<|0.001|TWO_SIDED|95.0|22.0|47.1|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||47.1|22.0|<0.001
70970506|NCT02706873|141446974|SUPERIORITY||Response Rate Difference|51.9|||<|0.001|TWO_SIDED|95.0|33.0|70.7|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||70.7|33.0|<0.001
70970507|NCT02706873|141446974|SUPERIORITY||Response Rate Difference|64.3|||<|0.001|TWO_SIDED|95.0|46.5|82.0|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||82.0|46.5|<0.001
70970508|NCT02706873|141446975|SUPERIORITY||LS Mean Difference|-1.43|||<|0.001|TWO_SIDED|95.0|-1.92|-0.95|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-0.95|-1.92|<0.001
70970509|NCT02706873|141446975|SUPERIORITY||LS Mean Difference|-1.86|||<|0.001|TWO_SIDED|95.0|-2.42|-1.3|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-1.30|-2.42|<0.001
70970510|NCT02706873|141446975|SUPERIORITY||LS Mean Difference|-1.92|||<|0.001|TWO_SIDED|95.0|-2.48|-1.36|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-1.36|-2.48|<0.001
70970511|NCT02706873|141446976|SUPERIORITY||LS Mean Difference|-0.54|||<|0.001|TWO_SIDED|95.0|-0.75|-0.34|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-0.34|-0.75|<0.001
70970512|NCT02706873|141446976|SUPERIORITY||LS Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-0.99|-0.51|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-0.51|-0.99|<0.001
70970513|NCT02706873|141446976|SUPERIORITY||LS Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-0.99|-0.51|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-0.51|-0.99|<0.001
70970514|NCT02706873|141446977|SUPERIORITY||LS Mean Difference|5.97|||<|0.001|TWO_SIDED|95.0|3.15|8.8|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||8.80|3.15|<0.001
70970515|NCT02706873|141446977|SUPERIORITY||LS Mean Difference|7.92|||<|0.001|TWO_SIDED|95.0|4.66|11.19|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||11.19|4.66|<0.001
70970516|NCT02706873|141446977|SUPERIORITY||LS Mean Difference|6.76|||<|0.001|TWO_SIDED|95.0|3.33|10.2|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||10.20|3.33|<0.001
70970517|NCT02706873|141446978|SUPERIORITY||Response Rate Difference|51.2|||<|0.001|TWO_SIDED|95.0|32.5|70.0|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||70.0|32.5|<0.001
70970518|NCT02706873|141446978|SUPERIORITY||Response Rate Difference|59.9|||<|0.001|TWO_SIDED|95.0|38.8|81.1|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||81.1|38.8|<0.001
70970519|NCT02706873|141446978|SUPERIORITY||Response Rate Difference|60.7|||<|0.001|TWO_SIDED|95.0|39.9|81.5|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||81.5|39.9|<0.001
70970520|NCT02706873|141446979|SUPERIORITY||Response Rate Difference|49.4|||<|0.001|TWO_SIDED|95.0|30.6|68.3|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||68.3|30.6|<0.001
70970521|NCT02706873|141446979|SUPERIORITY||Response Rate Difference|52.5|||<|0.001|TWO_SIDED|95.0|30.2|74.8|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||74.8|30.2|<0.001
71031524|NCT00048581|141571057|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 Social Functioning|4.92|||<|0.001|TWO_SIDED|95.0|2.71|7.12|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||7.12|2.71|<0.001
70910472|NCT00562965|141310375|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.1727|TWO_SIDED|95.0|0.05|1.81|||Cox proportional hazard regression model|Stratified Cox proportional hazard regression model was utilized.|In this regression model, treatment arm was the covariate and the strata (number of prior regimens, investigator's choice of therapy and geographical region) over which participants were stratified prior to randomization were the variables.|||1.81|0.05|0.1727
70910473|NCT00848211|141310399|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||ANOVA|||||||0.008
70910474|NCT00848211|141310401|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||ANOVA|||||||0.045
70970522|NCT02706873|141446979|SUPERIORITY||Response Rate Difference|64.3|||<|0.001|TWO_SIDED|95.0|44.2|84.3|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||84.3|44.2|<0.001
70970523|NCT02706873|141446980|SUPERIORITY||LS Mean Difference|-1.69||||0.063|TWO_SIDED|95.0|-3.47|0.09|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||0.09|-3.47|0.063
70970524|NCT02706873|141446980|SUPERIORITY||LS Mean Difference|-2.4||||0.022|TWO_SIDED|95.0|-4.45|-0.35|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-0.35|-4.45|0.022
70970525|NCT02706873|141446980|SUPERIORITY||LS Mean Difference|-2.45||||0.022|TWO_SIDED|95.0|-4.54|-0.35|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-0.35|-4.54|0.022
70970526|NCT02706873|141446981|SUPERIORITY||Response Rate Difference|36.2||||0.001|TWO_SIDED|95.0|14.4|58.0|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||58.0|14.4|0.001
70970527|NCT02706873|141446981|SUPERIORITY||Response Rate Difference|34.6||||0.01|TWO_SIDED|95.0|10.2|59.0|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||59.0|10.2|0.010
70970528|NCT02706873|141446981|SUPERIORITY||Response Rate Difference|33.0||||0.016|TWO_SIDED|95.0|7.9|58.1|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||58.1|7.9|0.016
70970529|NCT05051904|141446982|OTHER||Adjusted Hazard Ratio|0.5|||<|0.0001|TWO_SIDED|95.0|0.402|0.622|||Regression, Cox|Cox proportional hazard model with s-IPTW. 'Treatment' is the only Independent variable used to estimate the hazard ratios.|Hazard ratio \<1 favors Dabigatran.|||0.622|0.402|<0.0001
70970530|NCT05051904|141446982|OTHER||Adjusted Hazard Ratio|0.784||||0.0004|TWO_SIDED|95.0|0.686|0.896|||Regression, Cox|Cox proportional hazard model with s-IPTW. 'Treatment' is the only Independent variable used to estimate the hazard ratios.|Hazard ratio \<1 favors Rivaroxaban.|||0.896|0.686|0.0004
70970531|NCT05051904|141446982|OTHER||Adjusted Hazard Ratio|0.637|||<|0.0001|TWO_SIDED|95.0|0.514|0.791|||Regression, Cox|Cox proportional hazard model with s-IPTW. 'Treatment' is the only Independent variable used to estimate the hazard ratios.|Hazard ratio \<1 favors Dabigatran.|||0.791|0.514|<0.0001
70970532|NCT05051904|141446983|OTHER||Adjusted Hazard Ratio|0.78|||<|0.0001|TWO_SIDED|95.0|0.714|0.851|||Regression, Cox|Cox proportional hazard model with s-IPTW. 'Treatment' is the only Independent variable used to estimate the hazard ratios.|Hazard ratio \<1 favors Dabigatran.|||0.851|0.714|<0.0001
70970533|NCT05051904|141446983|OTHER||Adjusted Hazard Ratio|0.827|||<|0.0001|TWO_SIDED|95.0|0.777|0.88|||Regression, Cox|Cox proportional hazard model with s-IPTW. 'Treatment' is the only Independent variable used to estimate the hazard ratios.|Hazard ratio\<1 favors Rivaroxaban|||0.88|0.777|<0.0001
70970534|NCT02595723|141446999|OTHER|||||||0.003||||||Overall group difference adjusted for prior group, time, and baseline values.|Mixed Models Analysis|Model includes prior group, time, and baseline values to control for possible effects.||||||0.003
70970535|NCT00004259|141447000|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.36|TWO_SIDED|95.0|0.67|1.32|||Log Rank|||The hypothesized median survival time was 36 months for the RT+BCNU/CCNU arm and 54 months for the RT+TMZ arm, corresponding to a hazard ratio (HR) of 0.67. A sample size of 216 evaluable patients per arm would provide 90% power with a one-sided significance level of 0.05. The final analysis was planned after 155 deaths were observed. Interim efficacy analyses were planned after 52 and 104 deaths, with an interim futility analysis planned at 128 deaths.||1.32|0.67|0.36
70970536|NCT00004259|141447002|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.46|TWO_SIDED|95.0|0.55|1.16||2-sided|Gray's test||Reference level = RT + BCNU/CCNU|||1.16|0.55|0.46
70970537|NCT00004259|141447003|SUPERIORITY||||||<|0.001||||||2-sided|Chi-squared|||Overall toxicity||||<0.001
70970538|NCT00004259|141447003|SUPERIORITY|||||||0.76||||||2-sided|Chi-squared|||Non-hematologic toxicity||||0.76
70970539|NCT00004259|141447004|SUPERIORITY||Hazard Ratio (HR)|1.78||||0.08|TWO_SIDED|95.0|0.93|3.4|||Log Rank|Two-side significance level = 0.05|Reference level = Methylated MGMT|||3.40|0.93|0.08
70970540|NCT00004259|141447005|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.41|TWO_SIDED|95.0|0.7|2.35|||Log Rank|Two-sided confidence interval = 0.5|Reference level = Methylated|||2.35|0.70|0.41
70970541|NCT02076997|141447027|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
70970542|NCT02076997|141447033|OTHER|||||||||||||||||There was no statistical analysis performed for this aim as it was descriptive|There was no statistical analysis performed for this aim as it was descriptive|||
70970543|NCT02076997|141447034|OTHER||Odds Ratio (OR)|6.7|||||TWO_SIDED|95.0||||||||||||
70970544|NCT00531752|141447048|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.7947|STANDARD_ERROR_OF_MEAN|1.8848||0.6749|TWO_SIDED|80.0|-1.649|3.2383||P-values are not adjusted for multiple comparisons.|Mixed Models Analysis||Positive value for the LS mean difference indicates the estimate favors placebo.|Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.2383|-1.649|0.6749
70970545|NCT00531752|141447048|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4176|STANDARD_ERROR_OF_MEAN|2.0343||0.4886|TWO_SIDED|80.0|-1.218|4.0533||P-values are not adjusted for multiple comparisons.|Mixed Models Analysis||Positive value for the LS mean difference indicates the estimate favors placebo.|Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.0533|-1.218|0.4886
71031525|NCT00048581|141571057|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 Role Emotional|3.54||||0.013|TWO_SIDED|95.0|0.74|6.33|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||6.33|0.74|0.013
71031526|NCT00048581|141571057|SUPERIORITY_OR_OTHER||Adj Diff: Mental Health|2.7||||0.006|TWO_SIDED|95.0|0.79|4.6|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||4.60|0.79|0.006
71031527|NCT00048581|141571059|SUPERIORITY_OR_OTHER||Adj M Chg from BL: HAQ-DI|-0.34|||<|0.001|TWO_SIDED|95.0|-0.44|-0.23|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline = Adj M Chg From BL||-0.23|-0.44|<0.001
71031528|NCT00048581|141571059|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Dressing and Grooming|-0.32|||<|0.001|TWO_SIDED|95.0|-0.49|-0.14|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg From BL||-0.14|-0.49|<0.001
71031529|NCT00048581|141571059|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Arising|-0.32|||<|0.001|TWO_SIDED|95.0|-0.47|-0.16|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg From BL||-0.16|-0.47|<0.001
71031530|NCT00048581|141571059|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Eating|-0.48|||<|0.001|TWO_SIDED|95.0|-0.65|-0.3|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline = Adj M Chg From BL||-0.30|-0.65|<0.001
71031531|NCT00048581|141571059|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Walking|-0.26||||0.003|TWO_SIDED|95.0|-0.44|-0.09|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL||-0.09|-0.44|0.003
71031532|NCT00048581|141571059|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Hygiene|-0.22||||0.01|TWO_SIDED|95.0|-0.39|-0.05|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL||-0.05|-0.39|0.010
71031533|NCT00048581|141571059|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Reaching|-0.43|||<|0.001|TWO_SIDED|95.0|-0.61|-0.25|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL||-0.25|-0.61|<0.001
71031534|NCT00048581|141571059|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Gripping|-0.32|||<|0.001|TWO_SIDED|95.0|-0.49|-0.15|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL||-0.15|-0.49|<0.001
71031535|NCT00048581|141571059|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Activities|-0.4|||<|0.001|TWO_SIDED|95.0|-0.58|-0.22|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL||-0.22|-0.58|<0.001
71092157|NCT00855582|141690965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|0.71|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
70850244|NCT02785770|141188258|SUPERIORITY_OR_OTHER||LS mean difference|0.03||||0.9649|TWO_SIDED|90.0|-1.13|1.19|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.19|-1.13|0.9649
70910475|NCT02444143|141310421|OTHER|||||||0.29|||||||t-test, 2 sided|||||||0.29
70910476|NCT02444143|141310422|OTHER|||||||0.9|||||||t-test, 2 sided|||||||0.90
70910477|NCT00783718|141310449|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.7|||<|0.0001|TWO_SIDED|95.0|11.6|31.7|||Cochran-Mantel-Haenszel|||The primary comparison of the Induction Phase was tested using the Cochran-Mantel-Haenszel (CMH) chi-square test at a 5% significance level, with stratification according to the stratification factors (concomitant use of oral corticosteroids and previous exposure to tumor necrosis factor alpha (TNFα) antagonists or concomitant immunomodulator \[6-mercaptopurine or azathioprine\] use).||31.7|11.6|< 0.0001
70910478|NCT00783718|141310450|SUPERIORITY_OR_OTHER||Risk Difference (RD)|26.1|||<|0.0001|TWO_SIDED|95.0|14.9|37.2||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||The Hochberg method was applied to control the overall Type I error rate at a 5% significance level. If both P-values were ≤ 0.05, both dose regimens were to be declared significant. If 1 of the P-values for the 2 dose comparisons was \> 0.05, the other P-value was to be tested at the 0.025 level and declared significant only if the P-value was ≤ 0.025. If neither dose was declared significant for the primary endpoint, no further testing was to be conducted.||37.2|14.9|< 0.0001
70970546|NCT00531752|141447049|SUPERIORITY_OR_OTHER||LS Mean Difference|1.025|STANDARD_ERROR_OF_MEAN|1.7713||0.5643|TWO_SIDED|80.0|-1.262|3.3121|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.3121|-1.262|0.5643
70970547|NCT00531752|141447049|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9146|STANDARD_ERROR_OF_MEAN|1.8777||0.3107|TWO_SIDED|80.0|-0.51|4.3392|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.3392|-0.5100|0.3107
70970548|NCT00531752|141447049|SUPERIORITY_OR_OTHER||LS Mean Difference|2.3154|STANDARD_ERROR_OF_MEAN|1.4638||0.1196|TWO_SIDED|80.0|0.41601|4.2148|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.2148|0.41601|0.1196
70970549|NCT00531752|141447049|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3288|STANDARD_ERROR_OF_MEAN|1.524||0.3872|TWO_SIDED|80.0|-0.649|3.3065|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.3065|-0.6490|0.3872
70970550|NCT00531752|141447054|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1677|STANDARD_ERROR_OF_MEAN|1.0269||0.8708|TWO_SIDED|80.0|-1.162|1.4971|||Mixed Models Analysis|||Week 1 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.4971|-1.162|0.8708
70970551|NCT00531752|141447054|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8607|STANDARD_ERROR_OF_MEAN|1.0912||0.0927|TWO_SIDED|80.0|0.44874|3.2726|||Mixed Models Analysis|||Week 1 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.2726|0.44874|0.0927
70970552|NCT00531752|141447054|SUPERIORITY_OR_OTHER||LS Mean Difference|0.866|STANDARD_ERROR_OF_MEAN|0.9037||0.3405|TWO_SIDED|80.0|-0.3008|2.0329|||Mixed Models Analysis|||Week 1 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.0329|-0.3008|0.3405
70970553|NCT00531752|141447054|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1623|STANDARD_ERROR_OF_MEAN|0.9622||0.8665|TWO_SIDED|80.0|-1.08|1.4047|||Mixed Models Analysis|||Week 1 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.4047|-1.080|0.8665
70970554|NCT00531752|141447054|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3886|STANDARD_ERROR_OF_MEAN|0.9694||0.6901|TWO_SIDED|80.0|-0.8694|1.6466|||Mixed Models Analysis|||Week 2 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.6466|-0.8694|0.6901
70970555|NCT00531752|141447054|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3779|STANDARD_ERROR_OF_MEAN|1.0114||0.179|TWO_SIDED|80.0|0.06498|2.6908|||Mixed Models Analysis|||Week 2 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.6908|0.06498|0.1790
70970556|NCT00531752|141447054|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8759|STANDARD_ERROR_OF_MEAN|0.7508||0.0156|TWO_SIDED|80.0|0.90156|2.8502|||Mixed Models Analysis|||Week 2 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.8502|0.90156|0.0156
70970557|NCT00531752|141447054|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04217|STANDARD_ERROR_OF_MEAN|0.7842||0.9573|TWO_SIDED|80.0|-1.06|0.97559|||Mixed Models Analysis|||Week 2 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.97559|-1.060|0.9573
70970558|NCT00531752|141447054|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1602|STANDARD_ERROR_OF_MEAN|1.2517||0.8986|TWO_SIDED|80.0|-1.462|1.782|||Mixed Models Analysis|||Week 3 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.7820|-1.462|0.8986
70970559|NCT00531752|141447054|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6688|STANDARD_ERROR_OF_MEAN|1.3437||0.6204|TWO_SIDED|80.0|-1.071|2.4086|||Mixed Models Analysis|||Week 3 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.4086|-1.071|0.6204
70970560|NCT00531752|141447054|SUPERIORITY_OR_OTHER||LS Mean Difference|0.492|STANDARD_ERROR_OF_MEAN|0.8742||0.5759|TWO_SIDED|80.0|-0.6421|1.6261|||Mixed Models Analysis|||Week 3 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.6261|-0.6421|0.5759
70970561|NCT00531752|141447054|SUPERIORITY_OR_OTHER||LS Mean Difference|0.875|STANDARD_ERROR_OF_MEAN|0.9488||0.3603|TWO_SIDED|80.0|-0.3552|2.1051|||Mixed Models Analysis|||Week 3 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.1051|-0.3552|0.3603
71031536|NCT01059903|141571115|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of geometric LS-Means is included within 0.8-1.25, the patches are considered bioequivalent.|Ratio of geometric LS-Means|0.9028|||||TWO_SIDED|90.0|0.8411|0.969|||ANOVA|ANOVA for log-transformed values has been used as the basis for calculation of point estimates (LS-Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||0.9690|0.8411|
71031537|NCT01059903|141571116|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of geometric LS-Means is included within 0.8-1.25, the patches are considered bioequivalent.|Ratio of geometric LS-Means|0.9506|||||TWO_SIDED|90.0|0.8833|1.0231|||ANOVA|ANOVA for log-transformed values has been used as the basis for calculation of point estimates (LS-Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||1.0231|0.8833|
71031538|NCT01059903|141571117|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of geometric LS-Means is included within 0.8-1.25, the patches are considered bioequivalent.|Ratio of geometric LS-Means|0.9046|||||TWO_SIDED|90.0|0.8437|0.9699|||ANOVA|ANOVA for log-transformed values has been used as the basis for calculation of point estimates (LS-Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||0.9699|0.8437|
71031539|NCT02589808|141571270|OTHER|||||||0.0005|||||||Kappa|||||||0.0005
71031540|NCT01171690|141571276|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Matched pairs t test|||Matched pairs||||0.01
71031541|NCT00105196|141571301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.73|||<|0.001||95.0|-5.44|-2.02|||t-test, 2 sided|||The sample size for the study was based on the primary outcome measure. The study was powered at 90% to detect a treatment difference between adjunctive aripiprazole and adjunctive placebo of 3.75, assuming a standard deviation of 10.5 and a two-sided alpha level of 0.05. The null-hypothesis was the lack of a treatment difference.||-2.02|-5.44|<0.001
71031542|NCT00105196|141571302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.075||95.0|-0.88|0.04|||t-test, 2 sided|||To protect the overall (primary and key secondary efficacy analysis) alpha level of 0.05, for this key secondary endpoint a hierarchical testing procedure was followed such that formal testing would take place conditional on the primary efficacy analysis showing a statistically significant difference.||0.04|-0.88|0.075
70910479|NCT00783718|141310450|SUPERIORITY_OR_OTHER||Risk Difference (RD)|29.1|||<|0.0001|TWO_SIDED|95.0|17.9|40.4||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||The Hochberg method was applied to control the overall Type I error rate at a 5% significance level. If both P-values were ≤ 0.05, both dose regimens were to be declared significant. If 1 of the P-values for the 2 dose comparisons was \> 0.05, the other P-value was to be tested at the 0.025 level and declared significant only if the P-value was ≤ 0.025. If neither dose was declared significant for the primary endpoint, no further testing was to be conducted.||40.4|17.9|< 0.0001
70910480|NCT00783718|141310451|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.5||||0.0009|TWO_SIDED|95.0|4.7|18.3||P-value is based on the CMH chi-square test, with stratification according to: 1) concomitant use of oral corticosteroids (yes/no); and 2) previous exposure to TNFα antagonists or concomitant immunomodulator use (yes/no).|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially (closed sequential method). The first secondary endpoint was to be tested only if the primary comparison was significant and the second key secondary endpoint was to be tested only if the first secondary endpoint was significant for vedolizumab.||18.3|4.7|0.0009
70910481|NCT00783718|141310452|SUPERIORITY_OR_OTHER||Risk Difference (RD)|16.1||||0.0012||95.0|6.4|25.9||P-value is based on the CMH chi-square test, with stratification according to: 1) concomitant use of oral corticosteroids (yes/no); and 2) previous exposure to TNFα antagonists or concomitant immunomodulator use (yes/no).|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially (closed sequential method). The first secondary endpoint was to be tested only if the primary comparison was significant and the second key secondary endpoint was to be tested only if the first secondary endpoint was significant for vedolizumab.||25.9|6.4|0.0012
71031543|NCT00105196|141571303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.052||95.0|-1.06|0.0||No adjustment for multiple comparisons was implemented for this secondary endpoint.|t-test, 2 sided|||||0.00|-1.06|0.052
71031544|NCT00105196|141571304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.037||95.0|-1.1|-0.03||No adjustment for multiple comparisons was implemented for this secondary endpoint.|t-test, 2 sided|||||-0.03|-1.10|0.037
71092158|NCT00855582|141690966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.1|STANDARD_ERROR_OF_MEAN|3.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71031545|NCT00105196|141571305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.792||95.0|-0.67|0.51||No adjustment for multiple comparisons was implemented for this secondary endpoint.|t-test, 2 sided|||||0.51|-0.67|0.792
71031546|NCT00105196|141571306|SUPERIORITY_OR_OTHER||Ratio of response|1.74|||<|0.001||95.0|1.31|2.32||No adjustment for multiple comparisons was implemented for this secondary endpoint.|CMH General Association Test||aripiprazole/placebo|||2.32|1.31|<0.001
71031547|NCT00105196|141571307|SUPERIORITY_OR_OTHER||Ratio of response|1.43|||<|0.001||95.0|1.17|1.74||No adjustment for multiple comparisons was implemented for this secondary endpoint.|ANCOVA||aripiprazole/placebo|||1.74|1.17|<0.001
71031548|NCT00105196|141571308|SUPERIORITY_OR_OTHER||Ratio of remission|1.95|||<|0.001||95.0|1.36|2.8||No adjustment for multiple comparisons was implemented for this secondary endpoint.|CMH General Association Test||aripiprazole/placebo|||2.80|1.36|<0.001
71031549|NCT01382719|141571324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0215|STANDARD_DEVIATION|2.9|<|0.05|TWO_SIDED|95.0|0.0|1.0|||Van Elteren|||||1.0|0.0|<0.05
71031550|NCT01382719|141571324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0012|STANDARD_DEVIATION|0.0012|<|0.05|TWO_SIDED|95.0|0.0|0.06|||Van Elteren|||||0.06|0.00|<0.05
71031551|NCT01382719|141571325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0496|||<|0.05|||||||ANCOVA|||||||<0.05
71031552|NCT01382719|141571326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0079|||<|0.05|TWO_SIDED|95.0|0.0|1.0|||Van Elteren|||||1.00|0.00|<0.05
71031553|NCT01382719|141571327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0012|||<|0.05|||||||Van Elteren|||||||<0.05
71031554|NCT01382719|141571328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0013|||<|0.05|||||||Van Elteren|||||||<0.05
71031555|NCT01382719|141571329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1161|||<|0.05|||||||Van Elteren|||||||<0.05
71031556|NCT01382719|141571330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0133|||<|0.05|||||||ANCOVA|||||||<0.05
71031557|NCT02794974|141571432|SUPERIORITY|||||||0.236|||||||Fisher Exact|||||||0.236
71031558|NCT02794974|141571433|SUPERIORITY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||||||0.018
71031559|NCT02794974|141571434|SUPERIORITY||Odds Ratio|4.5||||0.209|TWO_SIDED|95.0|0.63|32.2|||Odds Ratio|||||32.2|0.63|0.209
71031560|NCT02794974|141571435|SUPERIORITY||Odds Ratio|2.5||||0.44|TWO_SIDED|95.0|0.49|12.77|||Odds Ratio|||||12.77|0.49|0.44
71031561|NCT02794974|141571436|SUPERIORITY||Odds Ratio|1.88||||0.695|TWO_SIDED|95.0|0.37|9.45|||Odds Ratio|||||9.45|0.37|0.695
71031562|NCT02996682|141571460|SUPERIORITY||||||<|0.001||||||P-value was from the 2-sided exact 1-sample binomial test for the superiority of each treatment group over pre-specified rate of 1%.|2-sided exact 1-sample binomial test|||A sample size of 50 participants in each treatment group would provide over 99% power to detect at least 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.025.||||<0.001
71031563|NCT02996682|141571460|SUPERIORITY||||||<|0.001||||||P-value was from the 2-sided exact 1-sample binomial test for the superiority of each treatment group over pre-specified rate of 1%.|2-sided exact 1-sample binomial test|||A sample size of 50 participants in each treatment group would provide over 99% power to detect at least 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.025.||||<0.001
71031564|NCT04274686|141571517|SUPERIORITY||Mean Difference (Final Values)|1.9||||0.667|TWO_SIDED|95.0|-7.0|10.7|||Paired t-test|||Null hypothesis: No difference in percent air leakage||10.7|-7.0|0.667
71031565|NCT04274686|141571518|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.218|TWO_SIDED|95.0|-0.7|2.9|||Paired t-test|||||2.90|-0.70|0.218
71031566|NCT04274686|141571519|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.455|TWO_SIDED|95.0|-0.5|0.2|||Paired t-test|||||0.2|-0.5|0.455
71031567|NCT00376623|141571520|OTHER|A one-sided exact binomial test with a 2.5 % significance level was used to detect the difference between BI 2536 and historical placebo with objective response rate = 0.9 % (two out of 211) with a 95 % confidence interval of 0.2 % to 3 %.||||||0.0548|||||||One-sided exact binomial test|Null hypothesis H0: p \<= 0.009 Alternative hypothesis HA: p \> 0.009||Efficacy of BI 2536 was evaluated by comparing the tumour response rate of the present trial with the tumour response rate published for patients with the same stage of disease treated with placebo. For this, treatment groups 'BI 2536 200 mg' and 'combination of treatment group 50 mg BI 2536 (day 1 - day 3) and 60 mg BI 2536 (day 1 - day 3)' were pooled together and compared to historical placebo.||||0.0548
71031568|NCT00376623|141571521|OTHER||Hazard Ratio (HR)|1.02||||0.92|TWO_SIDED|95.0|0.67|1.55|||Log Rank||"Hazard ratio calculated as Combination of 50 mg BI 2536 and 60 mg BI 2536 divided by 200 mg BI 2536"|Exploratory analysis. No formal hypotheses were tested.||1.55|0.67|0.92
71031569|NCT00376623|141571522|OTHER||Hazard Ratio (HR)|1.11||||0.65|TWO_SIDED|95.0|0.7|1.78|||Log Rank||"Hazard ratio calculated as Combination of 50 mg BI 2536 and 60 mg BI 2536 divided by 200 mg BI 2536"|Exploratory analysis. No formal hypotheses were tested.||1.78|0.7|0.65
71031570|NCT00376623|141571525|OTHER|Exploratory analysis. No formal hypotheses were tested.|Hazard Ratio (HR)|1.54|||||TWO_SIDED|95.0|0.94|2.51|||Regression, Cox||"Hazard ratio calculated as Combination of 50 mg BI 2536 and 60 mg BI 2536 divided by 200 mg BI 2536"|||2.51|0.94|
71031571|NCT00376623|141571526|OTHER|Exploratory analysis. No formal hypotheses were tested.|Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.59|1.49|||Regression, Cox||"Hazard ratio calculated as Combination of 50 mg BI 2536 and 60 mg BI 2536 divided by 200 mg BI 2536"|||1.49|0.59|
71031572|NCT00376623|141571527|OTHER|Exploratory analysis. No formal hypotheses were tested.|Hazard Ratio (HR)|1.27|||||TWO_SIDED|95.0|0.81|2.01|||Regression, Cox||"Hazard ratio calculated as Combination of 50 mg BI 2536 and 60 mg BI 2536 divided by 200 mg BI 2536"|||2.01|0.81|
71031573|NCT00286754|141571536|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||BP control and SBP were compared at 6 months across treatment arms using a Bonferroni adjustment of 1.25% for each of the 4 comparisons (SMI versus UC and HEI versus UC for BP control and SBP separately). This p-value is for comparison of SMI vs. UC|Wilcoxon (Mann-Whitney)|||The study was an effectiveness trial of 2 active interventions, each compared with an active standard of care control group. We expected that 54% of patients on BP-lowering therapy would be properly controlled with HEI and 43% with UC, whereas we expected SMI to increase this to 69% control in 6 months. BP control and SBP were compared at 6 months across treatment arms using a 2.5% type I error (Bonferroni adjustment), ie, 1.25% for each of the 4 comparisons.||||0.001
71031574|NCT00286754|141571536|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED|||||BP control and SBP were compared at 6 months across treatment arms using a Bonferroni adjustment of 1.25% for each of the 4 comparisons (SMI versus UC and HEI versus UC for BP control and SBP separately). This p-value is for comparison of HEI vs. UC|Wilcoxon (Mann-Whitney)|||||||0.108
71031575|NCT00286754|141571537|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED|||||BP control and SBP were compared at 6 months across treatment arms using a 2.5% type I error (Bonferroni adjustment), 1.25% for each of the 4 comparisons (SMI versus UC and HEI vs UC for BP control and SBP separately). This p-value is for SMI vs UC|Wilcoxon (Mann-Whitney)|||The study was designed as an effectiveness trial of 2 active interventions, each compared with an active standard of care control group. The study was not powered to test comparisons between the 2 active intervention arms.||||0.009
71092159|NCT00855582|141690966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.0|STANDARD_ERROR_OF_MEAN|3.0|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71092160|NCT00855582|141690966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.5|STANDARD_ERROR_OF_MEAN|3.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71092161|NCT00855582|141690966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.9|STANDARD_ERROR_OF_MEAN|2.9|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71092162|NCT00855582|141690967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.22||0.215||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.215
71092163|NCT00855582|141690967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.325||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.325
71092164|NCT00855582|141690967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71092165|NCT00855582|141690967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.23||0.011||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.011
71092166|NCT00855582|141690968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.38||0.23||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.230
71092167|NCT00855582|141690968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.37|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71092168|NCT00855582|141690969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.191||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.191
71092169|NCT00855582|141690969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.3|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71092170|NCT00855582|141690970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.763||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.763
71092171|NCT00855582|141690970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.075||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.075
71092172|NCT00855582|141690971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.384||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.384
71092173|NCT00855582|141690971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.082||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.082
71092174|NCT00855582|141690972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71092175|NCT00855582|141690972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71031576|NCT00286754|141571537|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED|||||BP control and SBP were compared at 6 months across treatment arms using a Bonferroni adjustment of 1.25% for each of the 4 comparisons (SMI versus UC and HEI vs UC for BP control and SBP separately). This p-value is for comparison of HEI vs. UC|Wilcoxon (Mann-Whitney)|||||||0.047
71031577|NCT00286754|141571538|SUPERIORITY_OR_OTHER||||||<|3e-06|TWO_SIDED|||||Change in BP control were compared by treatment arm using a 1.67% type I error (with Bonferroni adjustment), ie, 1.67% for each assessment of change in proportion with BP under control from baseline to 6 months by SMI, HEI or UC (3 tests).|McNemar|||||||<0.000003
71031578|NCT00286754|141571538|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||Change in BP control were compared by treatment arm using a 1.67% type I error (with Bonferroni adjustment), ie, 1.67% for each assessment of change in proportion with BP under control from baseline to 6 months by SMI, HEI or UC (3 tests).|McNemar|||||||0.012
71092176|NCT00855582|141690973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|0.3|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71092177|NCT00855582|141690973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.3|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71092178|NCT00855582|141690974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71092179|NCT00855582|141690974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71092180|NCT00855582|141690975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71092181|NCT00855582|141690975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71092182|NCT00855582|141690976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.1|STANDARD_ERROR_OF_MEAN|2.4|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71092183|NCT00855582|141690976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.8|STANDARD_ERROR_OF_MEAN|2.4|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71092184|NCT00855582|141690977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.9|STANDARD_ERROR_OF_MEAN|3.6|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71092185|NCT00855582|141690977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.7|STANDARD_ERROR_OF_MEAN|3.6|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71092186|NCT00855582|141690978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.8|STANDARD_ERROR_OF_MEAN|3.6|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71092187|NCT00855582|141690978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.4|STANDARD_ERROR_OF_MEAN|3.6|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71031579|NCT00286754|141571538|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED|||||Change in BP control were compared by treatment arm using a 1.67% type I error (with Bonferroni adjustment), ie, 1.67% for each assessment of change in proportion with BP under control from baseline to 6 months by SMI, HEI or UC (3 tests).|McNemar|||||||0.89
71031580|NCT00286754|141571539|SUPERIORITY_OR_OTHER||||||<|0.009|TWO_SIDED|||||Change in SBP were compared by treatment arm using a 1.67% type I error (Bonferroni adjustment), ie, 1.67% for each of the 3 comparisons by arm (6-month-baseline for SMI, HEI and UC separately).|Wilcoxon (Mann-Whitney)|||||||<0.009
71092188|NCT00855582|141690979|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for baseline LUTS severity.||||||<0.001
71092189|NCT00855582|141690979|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for baseline LUTS severity.||||||<0.001
71092190|NCT00855582|141690980|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for baseline LUTS severity.||||||0.006
71031581|NCT00286754|141571539|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||Change in SBP were compared by treatment arm using a 1.67% type I error (Bonferroni adjustment), ie, 1.67% for each of the 3 comparisons by arm (6-month-baseline for SMI, HEI and UC separately).|Wilcoxon (Mann-Whitney)|||||||0.008
71031582|NCT00286754|141571539|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED|||||Change in SBP were compared by treatment arm using a 1.67% type I error (Bonferroni adjustment), ie, 1.67% for each of the 3 comparisons by arm (6-month-baseline for SMI, HEI and UC separately).|Wilcoxon (Mann-Whitney)|||||||0.9
71031583|NCT00286754|141571540|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Wilcoxon (Mann-Whitney)|||||||0.880
71031584|NCT00286754|141571540|SUPERIORITY_OR_OTHER|||||||0.318|TWO_SIDED|||||Change in SBP were compared by treatment arm using a 1.67% type I error (Bonferroni adjustment), ie, 1.67% for each of the 3 comparisons by arm (6-month-baseline for SMI, HEI and UC separately).|Wilcoxon (Mann-Whitney)|||||||0.318
71092191|NCT00855582|141690980|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for baseline LUTS severity.||||||<0.001
70910482|NCT00783718|141310453|SUPERIORITY_OR_OTHER||Risk Difference (RD)|32.8|||<|0.0001|TWO_SIDED|95.0|20.8|44.7||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||44.7|20.8|< 0.0001
70910483|NCT00783718|141310453|SUPERIORITY_OR_OTHER||Risk Difference (RD)|28.5|||<|0.0001|TWO_SIDED|95.0|16.7|40.3||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||40.3|16.7|< 0.0001
70910484|NCT00783718|141310454|SUPERIORITY_OR_OTHER||Risk Difference (RD)|32.0|||<|0.0001|TWO_SIDED|95.0|20.3|43.8||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||43.8|20.3|< 0.0001
70910485|NCT00783718|141310454|SUPERIORITY_OR_OTHER||Risk Difference (RD)|36.3|||<|0.0001|TWO_SIDED|95.0|24.4|48.3||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||48.3|24.4|< 0.0001
71031585|NCT00286754|141571541|SUPERIORITY_OR_OTHER|||||||0.306|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Wilcoxon (Mann-Whitney)|||||||0.306
71031586|NCT00286754|141571541|SUPERIORITY_OR_OTHER|||||||0.205|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.205
71031587|NCT00286754|141571542|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared|||||||0.011
71031588|NCT00286754|141571542|SUPERIORITY_OR_OTHER|||||||0.638|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared|||||||0.638
71031589|NCT00286754|141571543|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared|||||||0.012
71031590|NCT00286754|141571543|SUPERIORITY_OR_OTHER|||||||0.333|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared|||||||0.333
71031591|NCT00286754|141571544|SUPERIORITY_OR_OTHER|||||||0.581|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared|||||||0.581
71031592|NCT00286754|141571544|SUPERIORITY_OR_OTHER|||||||0.502|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared|||||||0.502
71031593|NCT00910663|141571545|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|97.01||||||90.0|90.01|104.55|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.55|90.01|
71031594|NCT00910663|141571546|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|102.81||||||90.0|100.23|105.45|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.45|100.23|
71031595|NCT00910663|141571547|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|103.35||||||90.0|100.51|106.27|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.27|100.51|
71092192|NCT00855582|141690981|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for Question 1.|Regression, Logistic|Logistic regression model includes terms for treatment group, region and centered-baseline IIEF EF Domain score.||||||<0.001
71092193|NCT00855582|141690981|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for Question 2.|Regression, Logistic|Logistic regression model includes terms for treatment group, region and centered-baseline IIEF EF Domain score.||||||<0.001
70970562|NCT00531752|141447055|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5306|STANDARD_ERROR_OF_MEAN|1.6664||0.0392|TWO_SIDED|80.0|1.3659|5.6952|||Mixed Models Analysis|||Day 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.6952|1.3659|0.0392
70970563|NCT00531752|141447055|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9344|STANDARD_ERROR_OF_MEAN|1.7848||0.0003|TWO_SIDED|80.0|4.6177|9.2512|||Mixed Models Analysis|||Day 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||9.2512|4.6177|0.0003
70970564|NCT00531752|141447055|SUPERIORITY_OR_OTHER||LS Mean Difference|4.2888|STANDARD_ERROR_OF_MEAN|2.1861||0.0547|TWO_SIDED|80.0|1.4544|7.1232|||Mixed Models Analysis|||Day 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||7.1232|1.4544|0.0547
70970565|NCT00531752|141447055|SUPERIORITY_OR_OTHER||LS Mean Difference|5.6799|STANDARD_ERROR_OF_MEAN|2.3261||0.0176|TWO_SIDED|80.0|2.6655|8.6943|||Mixed Models Analysis|||Day 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||8.6943|2.6655|0.0176
70970566|NCT00531752|141447055|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7203|STANDARD_ERROR_OF_MEAN|2.5085||0.775|TWO_SIDED|80.0|-2.53|3.9704|||Mixed Models Analysis|||Day 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.9704|-2.530|0.7750
70970567|NCT00531752|141447055|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04276|STANDARD_ERROR_OF_MEAN|2.6874||0.9874|TWO_SIDED|80.0|-3.521|3.4357|||Mixed Models Analysis|||Day 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.4357|-3.521|0.9874
70970568|NCT00531752|141447055|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6252|STANDARD_ERROR_OF_MEAN|2.2268||0.7799|TWO_SIDED|80.0|-3.513|2.2629|||Mixed Models Analysis|||Day 4: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.2629|-3.513|0.7799
70970569|NCT00531752|141447055|SUPERIORITY_OR_OTHER||LS Mean Difference|3.1136|STANDARD_ERROR_OF_MEAN|2.3365||0.1881|TWO_SIDED|80.0|0.08338|6.1438|||Mixed Models Analysis|||Day 4: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.1438|0.08338|0.1881
70970570|NCT00531752|141447055|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6575|STANDARD_ERROR_OF_MEAN|1.9677||0.4032|TWO_SIDED|80.0|-0.8944|4.2094|||Mixed Models Analysis|||Day 5: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.2094|-0.8944|0.4032
70970571|NCT00531752|141447055|SUPERIORITY_OR_OTHER||LS Mean Difference|5.9254|STANDARD_ERROR_OF_MEAN|2.0796||0.0059|TWO_SIDED|80.0|3.2314|8.6193|||Mixed Models Analysis|||Day 5: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||8.6193|3.2314|0.0059
70970572|NCT00531752|141447055|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0921|STANDARD_ERROR_OF_MEAN|2.1098||0.6067|TWO_SIDED|80.0|-1.643|3.8273|||Mixed Models Analysis|||Day 6: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.8273|-1.643|0.6067
70970573|NCT00531752|141447055|SUPERIORITY_OR_OTHER||LS Mean Difference|4.2785|STANDARD_ERROR_OF_MEAN|2.2424||0.0614|TWO_SIDED|80.0|1.3709|7.186|||Mixed Models Analysis|||Day 6: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||7.1860|1.3709|0.0614
70970574|NCT00531752|141447055|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7149|STANDARD_ERROR_OF_MEAN|2.2086||0.7476|TWO_SIDED|80.0|-3.584|2.1546|||Mixed Models Analysis|||Day 7: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.1546|-3.584|0.7476
70970575|NCT00531752|141447055|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.3355|STANDARD_ERROR_OF_MEAN|2.4396||0.5863|TWO_SIDED|80.0|-4.499|1.8284|||Mixed Models Analysis|||Day 7: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.8284|-4.499|0.5863
70970576|NCT00531752|141447055|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1058|STANDARD_ERROR_OF_MEAN|2.0529||0.9591|TWO_SIDED|80.0|-2.771|2.5593|||Mixed Models Analysis|||Day 8: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.5593|-2.771|0.9591
70970577|NCT00531752|141447055|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4352|STANDARD_ERROR_OF_MEAN|2.2048||0.8442|TWO_SIDED|80.0|-3.294|2.4238|||Mixed Models Analysis|||Day 8: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.4238|-3.294|0.8442
70970578|NCT00531752|141447055|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6876|STANDARD_ERROR_OF_MEAN|2.0533||0.1977|TWO_SIDED|80.0|0.01391|5.3613|||Mixed Models Analysis|||Day 9: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.3613|0.01391|0.1977
70970579|NCT00531752|141447055|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8149|STANDARD_ERROR_OF_MEAN|2.2467||0.4235|TWO_SIDED|80.0|-1.108|4.7375|||Mixed Models Analysis|||Day 9: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.7375|-1.108|0.4235
70970580|NCT00531752|141447055|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6424|STANDARD_ERROR_OF_MEAN|1.9753||0.1882|TWO_SIDED|80.0|0.07015|5.2147|||Mixed Models Analysis|||Day 10: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.2147|0.07015|0.1882
71031596|NCT02865850|141571548|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.53|-0.1||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||-0.10|-0.53|
71031597|NCT02865850|141571549|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per Food and Drug Administration \[FDA\]) and 1.30 (per European Medicines Agency \[EMA\]).|Hazard Ratio (HR)|0.97|||=|0.995|TWO_SIDED|95.0|0.536|1.761|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0016 has been reported in this section.||1.761|0.536|=0.9950
71031598|NCT02865850|141571549|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96|||=|0.4877|TWO_SIDED|95.0|0.833|1.113|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 355 and 377 respectively; median time to first event (Q1, Q3) = 46.14 (24.71, 77.14) weeks versus 47.00 (22.43, 74.43) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.113|0.833|=0.4877
71031599|NCT02865850|141571550|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.134|||TWO_SIDED|95.0|-0.34|0.19||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||0.19|-0.34|
71031600|NCT02865850|141571551|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|1.04|||=|0.8871|TWO_SIDED|95.0|0.618|1.743|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0016 has been reported in this section.||1.743|0.618|=0.8871
71031601|NCT02865850|141571551|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96|||=|0.4096|TWO_SIDED|95.0|0.84|1.096|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first MACE plus hospitalization for heart failure or thromboembolic event Excluding vascular access thrombosis for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 420 and 449 respectively; median time to first event (Q1, Q3) = 42.07 (21.50, 71.14) weeks versus 45.29 (22.29, 72.43) weeks, respectively.||1.096|0.840|=0.4096
71031602|NCT02865850|141571552|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|1.36|||=|0.521|TWO_SIDED|95.0|0.67|2.771|||Gray's test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0016 has been reported in this section.||2.771|0.670|=0.5210
71031603|NCT02865850|141571552|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.95|||=|0.5007|TWO_SIDED|95.0|0.795|1.144|||Gray's test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first cardiovascular MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 225 and 242 respectively; median time to first event (Q1, Q3) = 43.29 (21.71, 77.14) weeks versus 45.79 (21.14, 73.86) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.144|0.795|=0.5007
71031604|NCT02865850|141571553|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|1.1|||=|0.9527|TWO_SIDED|95.0|0.452|2.666|||Gray's test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0016 has been reported in this section.||2.666|0.452|=0.9527
71031605|NCT02865850|141571553|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96|||=|0.6284|TWO_SIDED|95.0|0.766|1.195|||Gray's test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first cardiovascular death for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 150 and 160 respectively; median time to first event (Q1, Q3) = 43.71 (27.43, 77.14) weeks versus 49.29 (24.43, 74.07) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.195|0.766|=0.6284
71031606|NCT02865850|141571554|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.78|||=|0.5115|TWO_SIDED|95.0|0.388|1.555|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0016 has been reported in this section.||1.555|0.388|=0.5115
71031607|NCT02865850|141571554|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.95|||=|0.4878|TWO_SIDED|95.0|0.812|1.118|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first all-cause mortality for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 291 and 310 respectively; median time to first event (Q1, Q3) = 50.00 (29.71, 79.00) weeks versus 49.57 (25.86, 77.29) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.118|0.812|=0.4878
71031608|NCT02726581|141571565|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.62|1.3||||||||1.30|0.62|
71031609|NCT02726581|141571566|SUPERIORITY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.53|1.19||||||||1.19|0.53|
71031610|NCT02726581|141571567|SUPERIORITY||Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.39|1.46||||||||1.46|0.39|
71031611|NCT00552669|141571571|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||We used One way annalysis of a variance for means and standard deviation.||||<0.05
71031612|NCT00552669|141571572|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|||Based on our previous data the incidence of relevant clinical events was similar in both groups (ERACI III and ORAR II)||||0.05
71031613|NCT00552669|141571573|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||"power calculation 80% Hypothesis: No significant diferences between Target Vessel Revascularization (TVR) between both groups.~All events will be recorded and an independent blind for groups clinical events committee will adjudicate each one."||||<0.05
71031614|NCT01844375|141571574|EQUIVALENCE|equivalence analysis||||||0.75|||||||Kruskal-Wallis|||||||0.75
71031615|NCT03020615|141571595|SUPERIORITY|||||||0.033|||||||t-test, 2 sided|||||||0.033
71031616|NCT03020615|141571598|SUPERIORITY|||||||0.0005|||||||Exact Wilcoxon (Mann-Whitley), two-sided|||||||0.0005
71031617|NCT03020615|141571600|SUPERIORITY|||||||0.011|||||||Exact Wilcoxon (Mann-Whitney), two-sided|||||||0.011
70910486|NCT00783718|141310455|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.8||||0.0079|TWO_SIDED|95.0|3.1|20.5||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||20.5|3.1|0.0079
70910487|NCT00783718|141310455|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.3||||0.0009|TWO_SIDED|95.0|6.2|24.4||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||24.4|6.2|0.0009
70910488|NCT00783718|141310456|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.6||||0.012|TWO_SIDED|95.0|3.9|31.3||P-value based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||31.3|3.9|0.0120
70910489|NCT00783718|141310456|SUPERIORITY_OR_OTHER||Risk Difference (RD)|31.4|||<|0.0001|TWO_SIDED|95.0|16.6|46.2||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||46.2|16.6|< 0.0001
70910490|NCT03714022|141310518|EQUIVALENCE|Equivalence is concluded if the 90% CIs for the ratios of geometric means are contained within 0.8 to 1.25|Ratio of Geometric Means|0.998|||||TWO_SIDED|90.0|0.941|1.058|||||Cohort A vs Cohort B|||1.058|0.941|
70910491|NCT03714022|141310519|EQUIVALENCE|Equivalence is concluded if the 90% CIs for the ratios of geometric means are contained within 0.8 to 1.25|Ratio of Geometric Means|0.929|||||TWO_SIDED|90.0|0.884|0.976|||||Cohort A vs Cohort B|||0.976|0.884|
70910492|NCT03714022|141310521|EQUIVALENCE|Equivalence is concluded if the 90% CIs for the ratios of geometric means are contained within 0.8 to 1.25|Ratio of Geometric Means|0.936|||||TWO_SIDED|90.0|0.891|0.983|||||Cohort A vs Cohort B|||0.983|0.891|
70910493|NCT03714022|141310522|EQUIVALENCE|Equivalence is concluded if the 90% CIs for the ratios of geometric means are contained within 0.8 to 1.25|Ratio of Geometric Means|0.957|||||TWO_SIDED|90.0|0.915|1.001|||||Cohort A vs Cohort B|||1.001|0.915|
70910494|NCT04447820|141310569|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.3084|||||||Mixed Model for repeated measures (MMRM)|||||||0.3084
70910495|NCT04447820|141310569|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.593|||||||Mixed Model for repeated measures (MMRM)|||||||0.5930
70910496|NCT04447820|141310570|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.9788|||||||MMRM|||||||0.9788
70910497|NCT04447820|141310570|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.1314|||||||MMRM|||||||0.1314
70970581|NCT00531752|141447055|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2105|STANDARD_ERROR_OF_MEAN|2.0376||0.5555|TWO_SIDED|80.0|-1.44|3.8615|||Mixed Models Analysis|||Day 10: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.8615|-1.440|0.5555
71031618|NCT03020615|141571601|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.030
71031619|NCT03020615|141571604|SUPERIORITY|||||||0.0009|||||||Exact Wilcoxon (Mann-Whitney), two-sided|||||||0.0009
71092194|NCT00855582|141690981|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for Question 1.|Regression, Logistic|Logistic regression model includes terms for treatment group, region and centered-baseline IIEF EF Domain score.||||||<0.001
71092195|NCT00855582|141690981|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for Question 2.|Regression, Logistic|Logistic regression model includes terms for treatment group, region and centered-baseline IIEF EF Domain score.||||||<0.001
70910498|NCT04447820|141310571|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.884|||||||MMRM analysis|||||||0.8840
70910499|NCT04447820|141310571|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.1202|||||||MMRM analysis|||||||0.1202
70970582|NCT00531752|141447055|SUPERIORITY_OR_OTHER||LS Mean Difference|3.1804|STANDARD_ERROR_OF_MEAN|2.1934||0.1533|TWO_SIDED|80.0|0.33169|6.0292|||Mixed Models Analysis|||Day 11: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.0292|0.33169|0.1533
70970583|NCT00531752|141447055|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0511|STANDARD_ERROR_OF_MEAN|2.2662||0.3697|TWO_SIDED|80.0|-0.8912|4.9934|||Mixed Models Analysis|||Day 11: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.9934|-0.8912|0.3697
70970584|NCT00531752|141447055|SUPERIORITY_OR_OTHER||LS Mean Difference|1.764|STANDARD_ERROR_OF_MEAN|2.3939||0.4652|TWO_SIDED|80.0|-1.352|4.8801|||Mixed Models Analysis|||Day 12: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.8801|-1.352|0.4652
70970585|NCT00531752|141447055|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4377|STANDARD_ERROR_OF_MEAN|2.5148||0.8626|TWO_SIDED|80.0|-2.83|3.7058|||Mixed Models Analysis|||Day 12: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.7058|-2.830|0.8626
70970586|NCT00531752|141447055|SUPERIORITY_OR_OTHER||LS Mean Difference|3.7114|STANDARD_ERROR_OF_MEAN|1.6168||0.0261|TWO_SIDED|80.0|1.6105|5.8122|||Mixed Models Analysis|||Day 13: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.8122|1.6105|0.0261
70970587|NCT00531752|141447055|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2644|STANDARD_ERROR_OF_MEAN|1.7026||0.1895|TWO_SIDED|80.0|0.0533|4.4756|||Mixed Models Analysis|||Day 13: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.4756|0.05330|0.1895
70970588|NCT00531752|141447055|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1151|STANDARD_ERROR_OF_MEAN|3.0732||0.4994|TWO_SIDED|80.0|-1.961|6.1913|||Mixed Models Analysis|||Day 14: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.1913|-1.961|0.4994
70970589|NCT00531752|141447055|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5616|STANDARD_ERROR_OF_MEAN|3.3113||0.2945|TWO_SIDED|80.0|-0.8226|7.9458|||Mixed Models Analysis|||Day 14: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||7.9458|-0.8226|0.2945
70970590|NCT00531752|141447055|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7306|STANDARD_ERROR_OF_MEAN|2.9257||0.8056|TWO_SIDED|80.0|-4.622|3.1613|||Mixed Models Analysis|||Day 21: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.1613|-4.622|0.8056
70970591|NCT00531752|141447055|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3672|STANDARD_ERROR_OF_MEAN|3.8657||0.3922|TWO_SIDED|80.0|-1.725|8.4592|||Mixed Models Analysis|||Day 21: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||8.4592|-1.725|0.3922
70970592|NCT00531752|141447056|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5069|STANDARD_ERROR_OF_MEAN|0.8744||0.0913|TWO_SIDED|80.0|-2.643|-0.3705|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.3705|-2.643|0.0913
70970593|NCT00531752|141447056|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2078|STANDARD_ERROR_OF_MEAN|0.9165||0.8216|TWO_SIDED|80.0|-1.399|0.98326|||Mixed Models Analysis|||Day 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.98326|-1.399|0.8216
70970594|NCT00531752|141447057|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4181|STANDARD_ERROR_OF_MEAN|0.6887||0.5466|TWO_SIDED|80.0|-1.313|0.47668|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.47668|-1.313|0.5466
70970595|NCT00531752|141447057|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02518|STANDARD_ERROR_OF_MEAN|0.6772||0.9705|TWO_SIDED|80.0|-0.9035|0.85312|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.85312|-0.9035|0.9705
71031620|NCT03020615|141571606|SUPERIORITY|||||||0.0004|||||||Exact Wilcoxon (Mann-Whitney), two-sided|||||||0.0004
71031621|NCT03020615|141571608|SUPERIORITY|||||||0.75|||||||Exact Wilcoxon (Mann-Whitney), two-sided|||||||0.75
71031622|NCT03020615|141571610|SUPERIORITY|||||||0.0013|||||||Exact Wilcoxon (Mann-Whitney), two-sided|||||||0.0013
71031623|NCT03020615|141571611|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||||||0.013
71031624|NCT00252720|141571628|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.024||||0.8487|TWO_SIDED|95.0|0.8|1.312|||Log Rank|Generalized||||1.312|0.800|0.8487
71031625|NCT02514122|141571636|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.009|TWO_SIDED|95.0|0.29|1.9||The p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05.|t-test, 2 sided||Score was lower in the Ketamine group.|||1.9|0.29|0.009
71031626|NCT02514122|141571637|SUPERIORITY||Risk Difference (RD)|0.37|||<|0.001|TWO_SIDED|95.0|0.18|0.54|||Fisher Exact|||||.54|.18|<0.001
71031627|NCT03506386|141571705|OTHER||||||<|0.0001||||||Statistical differences among eligible performed, eligible not performed and not eligible participants were estimated by Log Rank test.|Log Rank|||||||< 0.0001
71031628|NCT01546545|141571750|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|No power calculation was performed. This was the first pilot and feasibility study. This data will be used to power future studies.||||||0.02|||||||t-test, 2 sided|||||||0.02
71031629|NCT01546545|141571751|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|No power calculation was performed. This was a pilot and feasibility study.||||||0.02|||||||t-test, 2 sided|||||||0.02
71031630|NCT01390844|141571756|SUPERIORITY_OR_OTHER||Difference in Percentage|34.63|||<|0.0001|TWO_SIDED|95.0|20.24|47.18|||Miettinen and Numinen|||Between-Group Comparison||47.18|20.24|<0.0001
71031631|NCT01390844|141571757|SUPERIORITY_OR_OTHER||Difference in Percentage|33.83||||0.0063|TWO_SIDED|95.0|10.15|52.18|||Miettinen and Numinen|||Between-Group Comparison||52.18|10.15|0.0063
71031632|NCT01390844|141571758|SUPERIORITY_OR_OTHER||Difference in Percentage|35.05|||<|0.0001|TWO_SIDED|95.0|20.51|47.72|||Miettinen and Numinen|||Between-Group Comparison||47.72|20.51|<0.0001
71031633|NCT01390844|141571759|SUPERIORITY_OR_OTHER||Difference in Percentage|33.18||||0.0086|TWO_SIDED|95.0|8.96|51.83|||Miettinen and Numinen|||Between-Group Comparison||51.83|8.96|0.0086
71031634|NCT01390844|141571760|SUPERIORITY_OR_OTHER||Difference in Percentage|29.08|||<|0.001|TWO_SIDED|95.0|15.26|42.22|||Miettinen and Nurminen|||Between-Group Comparison||42.22|15.26|<0.001
71031635|NCT01390844|141571761|SUPERIORITY_OR_OTHER||Difference in Percentage|36.13||||0.004|TWO_SIDED|95.0|12.12|55.01|||Mittienen and Nurminen|||Between-Group Comparison||55.01|12.12|0.004
71031636|NCT05093205|141571779|OTHER|0.15 mg LE \& 0.03 mg EE was the Reference treatment (Part B Period 1), PF-06882961 120 mg BID + 0.15 mg LE \& 0.03 mg EE was the Test treatment (Period 3).|Specified in comments|122.48|||||TWO_SIDED|90.0|106.96|140.25|||Mixed Models Analysis||A mixed effects model with treatment as a fixed effect and participant as a random effect was used was applied to calculate the ratio (Test/Reference) of adjusted means and 90% CIs for Ratio. The ratio (and 90% CI) is expressed as percentage.|||140.25|106.96|
71031637|NCT05093205|141571779|OTHER|0.15 mg LE \& 0.03 mg EE was the Reference treatment (Part B Period 1), PF-06882961 200 mg BID + 0.15 mg LE \& 0.03 mg EE was the Test treatment (Period 5).|Specified in comments|143.83|||||TWO_SIDED|90.0|122.64|168.68|||Mixed Models Analysis||A mixed effects model with treatment as a fixed effect and participant as a random effect was used was applied to calculate the ratio (Test/Reference) of adjusted means and 90% CIs for Ratio. The ratio (and 90% CI) is expressed as percentage.|||168.68|122.64|
71031638|NCT05093205|141571780|OTHER|0.15 mg LE \& 0.03 mg EE was the Reference treatment (Part B Period 1), PF-06882961 120 mg BID + 0.15 mg LE \& 0.03 mg EE was the Test treatment (Period 3).|Specified in comments|104.46|||||TWO_SIDED|90.0|92.56|117.89|||Mixed Models Analysis||A mixed effects model with treatment as a fixed effect and participant as a random effect was used was applied to calculate the ratio (Test/Reference) of adjusted means and 90% CIs for Ratio. The ratio (and 90% CI) is expressed as percentage.|||117.89|92.56|
71031639|NCT05093205|141571780|OTHER|0.15 mg LE \& 0.03 mg EE was the Reference treatment (Part B Period 1), PF-06882961 200 mg BID + 0.15 mg LE \& 0.03 mg EE was the Test treatment (Period 5).|Specified in comments|92.77|||||TWO_SIDED|90.0|81.05|106.19|||Mixed Models Analysis||A mixed effects model with treatment as a fixed effect and participant as a random effect was used was applied to calculate the ratio (Test/Reference) of adjusted means and 90% CIs for Ratio. The ratio (and 90% CI) is expressed as percentage.|||106.19|81.05|
71031640|NCT03693430|141571817|SUPERIORITY|Week 104 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline body weight as covariate. Missing observations were multiple (x1000) imputed from retrieved subjects of the same randomised treatment arm.|Treatment difference|-12.55|||<|0.0001|TWO_SIDED|95.0|-15.33|-9.77|||ANCOVA|||Treatment policy estimand||-9.77|-15.33|<.0001
71031641|NCT03693430|141571817|SUPERIORITY|All responses prior to first discontinuation of treatment (or initiation of other anti-obesity medication or bariatric surgery) were included in a mixed model for repeated measurements with randomised treatment as factor and baseline body weight as covariate, all nested within visit.|Treatment difference|-16.05|||<|0.0001|TWO_SIDED|95.0|-18.64|-13.45|||MMRM (Mixed model repeated measurement)|||Hypothetical estimand||-13.45|-18.64|<0.0001
71031642|NCT03693430|141571818|SUPERIORITY||Odds Ratio (OR)|4.99|||<|0.0001|TWO_SIDED|95.0|2.95|8.42|||Regression, Logistic|||Treatment policy estimand||8.42|2.95|<0.0001
71031643|NCT03693430|141571818|SUPERIORITY||Odds Ratio (OR)|18.06|||<|0.0001|TWO_SIDED|95.0|10.04|32.49|||MMRM|||Hypothetical estimand||32.49|10.04|<0.0001
71031644|NCT04185909|141571854|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<.0001
71031645|NCT03567174|141571912|SUPERIORITY||Mean Difference (Net)|-0.306||||0.125|TWO_SIDED|95.0|-0.697|0.085|||Mixed Models Analysis|||||0.085|-0.697|0.125
71031646|NCT00722124|141572015|SUPERIORITY_OR_OTHER|||||||0.615||95.0|||||Fisher Exact|1 sided||Data were compared between treatment groups using Fisher's Exact test.||||0.615
71031647|NCT00722124|141572015|SUPERIORITY_OR_OTHER|||||||0.826||95.0|||||Fisher Exact|1 sided||Data were compared between treatment groups using Fisher's Exact test.||||0.826
71031648|NCT00840632|141572016|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|93.26||||||90.0|83.39|104.31|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.31|83.39|
71092196|NCT00855582|141690982|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Ranked ANOVA|||||||0.027
71031649|NCT00840632|141572017|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|100.35||||||90.0|92.08|109.36|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109.36|92.08|
71031650|NCT00840632|141572018|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|99.17||||||90.0|92.71|106.08|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.08|92.71|
70910500|NCT04447820|141310572|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.9353|||||||MMRM|||||||0.9353
70910501|NCT04447820|141310572|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.3099|||||||MMRM|||||||0.3099
70910502|NCT04447820|141310573|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.2098|||||||MMRM|||||||0.2098
70910503|NCT04447820|141310573|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.3688|||||||MMRM|||||||0.3688
70910504|NCT04447820|141310574|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.5647|||||||MMRM|||||||0.5647
70910505|NCT04447820|141310574|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.217|||||||MMRM|||||||0.2170
70910506|NCT04447820|141310575|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.2562|||||||MMRM|||||||0.2562
70910507|NCT04447820|141310575|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.4268|||||||MMRM|||||||0.4268
70910508|NCT00235495|141310589|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.84|1.1||The generalized linear model with log link function is tested at the one-sided alpha level of 0.025.|Regression, Logistic|Adjustment is made for baseline NIHSS and Thrombolysis stratum.|Adjusted risk ratio greater than 1 indicates greater risk of good outcome in the Albumin treatment group, while adjusted risk ratio less than 1 indicates greater risk of good outcome in the Saline treatment group.|Test of null hypothesis (equal proportions of subjects with NIHSS 0-1 or mRS 0-1 or both at 90 days post-randomization in Albumin and Saline treatment arms) versus alternative hypothesis (greater proportion of subjects with NIHSS 0-1 or mRS 0-1 or both at 90 days post-randomization in Albumin treatment arm).||1.10|0.84|
70910509|NCT00235495|141310590|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.93|||||TWO_SIDED|99.0|0.8|1.09|||Regression, Logistic|||||1.09|0.80|
70910510|NCT00235495|141310591|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.99|||||TWO_SIDED|99.0|0.66|1.49|||Regression, Logistic|||||1.49|0.66|
71031651|NCT00840632|141572019|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|102.93||||||90.0|99.8|106.15|||||Informational Purposes Only|||106.15|99.80|
71031652|NCT00840632|141572020|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|100.24||||||90.0|98.11|102.43|||||Informational Purposes Only|||102.43|98.11|
71031653|NCT00840632|141572021|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|100.1||||||90.0|98.12|102.12|||||Informational Purposes Only|||102.12|98.12|
71031654|NCT02262377|141572062|SUPERIORITY|The ITT analysis was done for 21 week average pain.|Risk Ratio (RR)|1.03||||0.68|TWO_SIDED|95.0|0.92|1.15||Statistical significance was set at p\< 0.05.|Regression, Poisson|||Intention to Treat Analysis for average chronic pain.||1.15|0.92|0.68
70910511|NCT00235495|141310592|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.88|||||TWO_SIDED|99.0|0.71|1.1|||Regression, Logistic|||||1.10|0.71|
70910512|NCT00235495|141310593|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.03|||||TWO_SIDED|99.0|0.82|1.28|||Regression, Logistic|||||1.28|0.82|
70910513|NCT00235495|141310594|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.99|||||TWO_SIDED|99.0|0.85|1.13|||Regression, Logistic|||||1.13|0.85|
70910514|NCT00235495|141310595|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.98|||||TWO_SIDED|99.0|0.87|1.11|||Regression, Logistic|||||1.11|0.87|
70910515|NCT00235495|141310596|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.95|||||TWO_SIDED|99.0|0.83|1.1|||Regression, Logistic|||||1.10|0.83|
70910516|NCT00235495|141310597|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.99|||||TWO_SIDED|99.0|0.84|1.17|||Regression, Logistic|||||1.17|0.84|
70910517|NCT00235495|141310598|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.93|||||TWO_SIDED|99.0|0.84|1.02|||Regression, Logistic|||||1.02|0.84|
70910518|NCT00235495|141310599|SUPERIORITY_OR_OTHER_LEGACY||Rank Sum|73098.0||||0.913||95.0|||||Wilcoxon rank sum test, normal approx|||||||0.913
70910519|NCT00235495|141310600|SUPERIORITY_OR_OTHER_LEGACY||Rank Sum|44853.5||||0.923||95.0|||||Wilcoxon rank sum test, normal approx|||||||0.923
71031655|NCT02262377|141572062|SUPERIORITY|The ITT analysis was done for 21 week BPI Interference.|Risk Ratio (RR)|0.98||||0.36|TWO_SIDED|95.0|0.88|1.08||Statistical significance was set at p\< 0.05.|Regression, Poisson|||||1.08|0.88|0.36
71031656|NCT02262377|141572062|SUPERIORITY|The ITT analysis was done for 21 week BPI Severity.|Risk Ratio (RR)|1.0||||0.996|TWO_SIDED|95.0|0.86|1.16||Statistical significance was set at p\< 0.05.|Regression, Poisson|||||1.16|0.86|0.996
70910520|NCT00235495|141310601|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.18|||||TWO_SIDED|95.0|0.79|1.76|||Regression, Logistic|||||1.76|0.79|
70910521|NCT00235495|141310602|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.47|2.15|||Regression, Logistic|||||2.15|0.47|
70910522|NCT00235495|141310603|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.39|3.41|||Regression, Logistic|||||3.41|0.39|
70910523|NCT00235495|141310604|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.69|||||TWO_SIDED|95.0|0.98|2.94|||Regression, Logistic|||||2.94|0.98|
70910524|NCT00235495|141310605|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|10.8|||||TWO_SIDED|95.0|4.37|26.72|||Regression, Logistic|||||26.72|4.37|
70910525|NCT00235495|141310606|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.58|||||TWO_SIDED|95.0|1.09|6.12|||Regression, Logistic|||||6.12|1.09|
70910526|NCT00235495|141310607|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.42|||||TWO_SIDED|95.0|1.02|5.78|||Regression, Logistic|||||5.78|1.02|
70910527|NCT00235495|141310608|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.68|2.01|||Regression, Logistic|||||2.01|0.68|
71031657|NCT02262377|141572063|SUPERIORITY||Risk Ratio (RR)|1.17||||0.054|TWO_SIDED|95.0|0.99|1.37|||Regression, Poisson|||||1.37|0.99|0.054
70910528|NCT00235495|141310609|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.68|1.61|||Regression, Logistic|||||1.61|0.68|
70910529|NCT00235495|141310610|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.74|1.63|||Regression, Logistic|||||1.63|0.74|
70910530|NCT04996069|141310640|SUPERIORITY|No power calculation performed.||||||0.45||||||p value threshold is .05|t-test, 2 sided|||||||.45
70910531|NCT04060680|141310643|SUPERIORITY|The pre-specified Objective Performance Criterion (OPC) for the major complication free rate at 6 months is 0.79. If the lower confidence bound of two-sided 95% confidence interval for the freedom from the first major EV ICD System/procedure-related complication through 182 days post implant exceeds 0.79, the primary safety objective will be met. The freedom from the first major EV ICD System/procedure-related complication was estimated using the Kaplan-Meier method.|Major complication-free rate|92.6|||<|0.0001|TWO_SIDED|95.0|89.0|95.0||A priori threshold for statistical significance is 0.025|Kaplan-Meier method|||The primary safety objective is to demonstrate the freedom from major complications related to the EV ICD System and/or procedure at 6 months post-implant exceeds an OPC of 79%. H0: p ≤ 0.79 HA: p \> 0.79, where p denotes the 6-month (182 days) freedom from major EV ICD System/procedure-related complications rate.||95.0|89.0|<0.0001
70910532|NCT04060680|141310644|SUPERIORITY|The pre-specified OPC for the EV ICD defibrillation testing success at implant is 0.88. If the lower confidence bound of two-sided 95% confidence interval for the proportion of EV ICD patients achieving defibrillation testing success at implant exceeds 0.88, the primary efficacy objective will be met. The primary efficacy objective will be evaluated using a one-proportion binomial exact test along with a two-sided 95% Clopper-Pearson confidence bound.|Proportion|98.7|||<|0.0001|TWO_SIDED|95.0|96.6|99.6||A priori threshold for statistical significance is 0.025|One-proportion binomial exact test|||The primary efficacy is to demonstrate the EV ICD defibrillation testing success rate at implant is greater than an OPC of 88%. H0: p ≤ 0.88 HA: p \> 0.88, where p denotes the probability of EV ICD defibrillation success at implant.||99.6|96.6|<0.0001
70910533|NCT00935792|141310646|OTHER||||||||||||||||||Estimated maximum tolerated dose was 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.|||
70910534|NCT04739423|141310652|OTHER||Least Squares Mean|5.4822||||0.0479|TWO_SIDED|95.0|0.0575|10.9069|||Mixed Models Analysis|||Between treatment analysis for Accuracy for happiness - change from baseline to Day 14.||10.9069|0.0575|0.0479
70910535|NCT04739423|141310652|OTHER||Least Squares Mean|4.7954||||0.0161|TWO_SIDED|95.0|0.9843|8.6064|||Mixed Models Analysis|||Between treatment analysis for Accuracy for sadness - Change from baseline to Day 14||8.6064|0.9843|0.0161
70910536|NCT04739423|141310652|OTHER||Least Squares Mean|167.29||||0.0237|TWO_SIDED|95.0|25.36|309.23|||Mixed Models Analysis|||Between treatment analysis of Reaction time for anger - change from baseline to Day 7||309.23|25.36|0.0237
70910537|NCT04739423|141310652|OTHER||Least Squares Mean|-1.2761||||0.7188|TWO_SIDED|95.0|-9.2424|6.6902|||Mixed Models Analysis|||Between treatment analysis for Accuracy for happiness - change from baseline to Day 14||6.6902|-9.2424|0.7188
70910538|NCT04739423|141310652|OTHER||Least Squares Mean|1.8955||||0.5478|TWO_SIDED|95.0|-4.9026|8.6935|||Mixed Models Analysis|||Between treatment analysis for Accuracy for sadness - Change from baseline to Day 14||8.6935|-4.9026|0.5478
70910539|NCT04739423|141310652|OTHER||Least Squares Mean|-7.52||||0.951|TWO_SIDED|95.0|-291.21|276.17|||Mixed Models Analysis|||Between treatment analysis of Reaction time for anger - change from baseline to Day 7||276.17|-291.21|0.9510
71031658|NCT02262377|141572064|SUPERIORITY||Risk Ratio (RR)|1.0||||0.98|TWO_SIDED|95.0|0.89|1.13|||Regression, Poisson|||||1.13|0.89|0.98
71031659|NCT02262377|141572065|SUPERIORITY||Odds Ratio (OR)|0.42|||||TWO_SIDED|95.0|0.18|0.98|||Odds Ratio|||||0.98|0.18|
70910540|NCT04739423|141310654|OTHER||Least Squares Mean|0.68||||0.0737|TWO_SIDED|95.0|-0.066|1.432|||Mixed Models Analysis|||Between treatment analysis for Immediate Word Recall: number of words - Change from Baseline to Day 1, 4 hours post-dose||1.432|-0.066|0.0737
70910541|NCT04739423|141310654|OTHER||Least Squares Mean|1.12||||0.0033|TWO_SIDED|95.0|0.382|1.868|||Mixed Models Analysis|||Between treatment analysis for Immediate Word Recall: number of words - Change from Baseline to Day 14, 4 hours post-dose||1.868|0.382|0.0033
70910542|NCT04739423|141310654|OTHER||Least Squares Mean|1.72||||0.0029|TWO_SIDED|95.0|0.6|2.84|||Mixed Models Analysis|||Between treatment comparison for Delayed Word Recall: number of words - Change from Baseline to Day 1, 4 hours post-dose||2.840|0.600|0.0029
70910543|NCT04739423|141310654|OTHER||Least Squares Mean|1.29||||0.0247|TWO_SIDED|95.0|0.168|2.418|||Mixed Models Analysis|||Between treatment analysis for Delayed Word Recall: number of words - Change from Baseline to Day 7, 4 hours post-dose||2.418|0.168|0.0247
70910544|NCT04739423|141310654|OTHER||Least Squares Mean|1.69||||0.0016|TWO_SIDED|95.0|0.653|2.732|||Mixed Models Analysis|||Between treatment analysis for Delayed Word Recognition: number of words - Change from Baseline to Day 7, 4 hours post-dose||2.732|0.653|0.0016
70910545|NCT04739423|141310654|OTHER||Least Squares Mean|-0.06||||0.9126|TWO_SIDED|95.0|-1.127|1.009|||Mixed Models Analysis|||Between treatment analysis for Immediate Word recall: number of words - Change from Baseline to Day 1, 4 hours post-dose||1.009|-1.127|0.9126
70910546|NCT04739423|141310654|OTHER||Least Squares Mean|-0.24||||0.657|TWO_SIDED|95.0|-1.317|0.837|||Mixed Models Analysis|||Between treatment analysis for Immediate Word Recall: number of words - Change from Baseline to Day 14, 4 hours post-dose||0.837|-1.317|0.6570
70910547|NCT04739423|141310654|OTHER||Least Squares Mean|-0.06||||0.9458|TWO_SIDED|95.0|-1.787|1.669|||Mixed Models Analysis|||Between treatment comparison for Delayed Word Recall: number of words - Change from Baseline to Day 1, 4 hours post-dose||1.669|-1.787|0.9458
70910548|NCT04739423|141310654|OTHER||Least Squares Mean|0.97||||0.2327|TWO_SIDED|95.0|-0.642|2.579|||Mixed Models Analysis|||Between treatment analysis for Delayed Word Recall: number of words - Change from Baseline to Day 7, 4 hours post-dose||2.579|-0.642|0.2327
70910549|NCT04739423|141310654|OTHER||Least Squares Mean|0.84||||0.4154|TWO_SIDED|95.0|-1.208|2.879|||Mixed Models Analysis|||Between treatment analysis for Delayed Word Recognition: number of words - Change from Baseline to day 7, 4 hours post-dose||2.879|-1.208|0.4154
71031660|NCT02262377|141572066|SUPERIORITY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.9|1.14|||Odds Ratio|||||1.14|0.90|
71031661|NCT00723528|141572073|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Fisher's exact test (using Holm's method)|Fisher Exact|||||||<0.0001
70910550|NCT04739423|141310655|OTHER||Least Squares Mean|5.06|||<|0.0001|TWO_SIDED|95.0|3.956|6.16|||Mixed Models Analysis|||Between treatment analysis (active - placebo) for Sleeping Heart Rate change from baseline across periods||6.160|3.956|<0.0001
70910551|NCT04739423|141310656|OTHER||Least Squares Mean|1.0||||0.0017|TWO_SIDED|95.0|0.432|1.565|||Mixed Models Analysis|||Between treatment analysis (active - placebo) for sleeping HRV change from baseline across periods.||1.565|0.432|0.0017
70910552|NCT04739423|141310657|OTHER||Least Squares Mean|-10.22||||0.0049|TWO_SIDED|95.0|-16.867|-3.567|||Mixed Models Analysis|||Between treatment analysis (active - placebo) for sleeping HRV root mean square of successive differences change from baseline across periods||-3.567|-16.867|0.0049
70910553|NCT00901485|141310689|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To test for non-inferiority, a sample size of 36 (18 patients completing both arms of the crossover) was calculated to provide 80% power to detect a 2.5% drop in the primary outcome, mean overnight oxygen saturation (SpO2), with a SD of 3% at a significance level of 0.05|Median Difference (Final Values)|0.4||||0.13|TWO_SIDED|95.0|-0.2|1.0||a priori threshold for significance p\<0.05|Wilcoxon (Mann-Whitney)|||"We tested the hypothesis that iVAPS can ventilate a patient naive to NIV at least as effectively as standard PS.~Sleep and breathing parameters at the end of each treatment period were compared using Wilcoxon Signed Rank test. The median difference between treatments with 95% confidence intervals was then compared by related-samples Hodges-Lehman test"||1.0|-0.2|0.13
70910554|NCT00901485|141310690|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|PtcCO2 is compared as a secondary outcome resulting in CO2 elimination similar to that of standard PS ventilation (median difference (95% CI) of -0.04(- 0.03 to 0.4)kPa in mean overnight PtcCO2).|Median Difference (Final Values)|0.0||||0.54|TWO_SIDED|95.0|-0.3|0.4|||Wilcoxon (Mann-Whitney)|||Hypothesis: that we tested the hypothesis that iVAPS, with automated selection of ventilator settings, was non-inferior to standard pressure support (PS) ventilation, with settings determined by an experienced healthcare professional, for controlling nocturnal hypoventilation in patients naïve to NIV.||0.4|-0.3|0.54
70910555|NCT00901485|141310691|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|0.0||||0.94|TWO_SIDED|95.0|-0.5|0.5|||Wilcoxon (Mann-Whitney)|||||0.5|-0.5|0.94
71031662|NCT00723528|141572074|SUPERIORITY_OR_OTHER||||||<|0.0001||||||2-sample t-test (using Holm's method)|t-test, 2 sided|||||||<0.0001
71031663|NCT00723528|141572084|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Fisher's exact test (using Holm's method)|Fisher Exact|||||||<0.0001
70910556|NCT00901485|141310692|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|-1.0||||0.42|TWO_SIDED|95.0|-2.0|1.0|||Wilcoxon (Mann-Whitney)|||||1|-2|0.42
70910557|NCT00901485|141310693|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|0.0||||0.82||95.0|-8.0|4.0|||Wilcoxon (Mann-Whitney)|||||4|-8|0.82
70910558|NCT00901485|141310694|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|1.04||||0.0004|TWO_SIDED|95.0|0.27|1.44|||Wilcoxon (Mann-Whitney)|||||1.44|0.27|0.0004
70910559|NCT00901485|141310695|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Mean Difference (Net)|-0.2||||0.5|TWO_SIDED|95.0|-1.2|0.5|||Wilcoxon (Mann-Whitney)|||||0.5|-1.2|0.5
70910560|NCT00901485|141310696|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|-2.2||||0.001|TWO_SIDED|95.0|-4.5|0.3|||Wilcoxon (Mann-Whitney)|||||0.3|-4.5|0.001
71031664|NCT01993030|141572086|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED|||||Values of p \< 0.05 were considered to be significantly different.|Fisher Exact|||"Two-sided Fisher's exact test was performed to assess statistically significant differences of the data of the Number of Participants with Growth of Granulation Tissue between the group treated with the HQ® Matrix Medical Wound Dressing and that treated with the Sidaiyi® wound dressing.~This Statistical Analysis applies to the Participants with healthy granulation tissue and the Participants with unhealthy granulation tissue category."||||0.49
70910561|NCT00901485|141310697|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|-10.0||||0.47|TWO_SIDED|95.0|-54.0|23.0|||Wilcoxon (Mann-Whitney)|||||23|-54|0.47
70910562|NCT00901485|141310698|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|0.3||||0.41|TWO_SIDED|95.0|-0.7|2.2|||Wilcoxon (Mann-Whitney)|||||2.2|-0.7|0.41
70910563|NCT00901485|141310699|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|4.0||||0.36|TWO_SIDED|95.0|-5.0|12.0|||Wilcoxon (Mann-Whitney)|||||12|-5|0.36
70910564|NCT00901485|141310700|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|2.0||||0.59|TWO_SIDED|95.0|-5.0|14.0|||Wilcoxon (Mann-Whitney)|||||14|-5|0.59
70910565|NCT00901485|141310701|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|2.0||||0.59|TWO_SIDED|95.0|-5.0|14.0|||Wilcoxon (Mann-Whitney)|||||14|-5|0.59
70910566|NCT00901485|141310702|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|-1.0||||0.72|TWO_SIDED|95.0|-9.0|5.0|||Wilcoxon (Mann-Whitney)|||||5|-9|0.72
70910567|NCT01852162|141310705|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||An analysis of covariance (ANCOVA) method with a general linear model, using the corresponding baseline PD value as a covariate, was used to evaluate the comparisons between dabigatran and placebo at 7 days.|ANCOVA|||Assuming a 20% relative difference in TRAP induced MPA between dabigatran and placebo with a common standard deviation of 10%, 13 patients with available data needed to be randomized to obtain a 95% power and 2-sided alpha=0.05.||||<0.05
70910568|NCT01866475|141310711|NON_INFERIORITY|This study is designed to test the hypothesis that the IO device has no greater than a 4 percent infection rate. Equivalently, we define success as having at least a 96 percent infection free 48-hour placement.|||||||||||||||||The historical data for the device suggests an infection rate of 0.6 percent per 48 hours or a success rate of 99.4 percent. The formal objective in the design is to reject the one-sided null hypothesis that the success rate is no higher than 96 percent. The analysis will use the exact binomial test and will tolerate a Type I Error rate of 0.05 or less. If we assume a 99.4 percent success rate, the study will have 84 percent power with a sample size of 117 to reject the null hypothesis. If the null hypothesis is rejected, we conclude that the infection rate is less than 4 percent.|||
70910569|NCT00231179|141310729|NON_INFERIORITY_OR_EQUIVALENCE|Sample sizes were established when the trial was first developed. For all power calculations, we set alpha = .05 and beta = .20 and specified 2-tailed tests.|Mean Difference (Final Values)|0.81|STANDARD_DEVIATION|15.0||0.59|TWO_SIDED|95.0|0.31|2.13||Bonferroni corrections were made for multiple comparisons.|t-test, 2 sided|||We compared scores for verbal, performance, and full scale Intelligence Quotient (IQ).||2.13|0.31|0.59
70910570|NCT00231179|141310730|NON_INFERIORITY_OR_EQUIVALENCE|Please see earlier power calculation.|Hazard Ratio (HR)|10.0|STANDARD_ERROR_OF_MEAN|5.0||0.72|TWO_SIDED|95.0|||||Chi-squared|||||||0.72
70910571|NCT00231179|141310731|NON_INFERIORITY_OR_EQUIVALENCE|See previous.|Hazard Ratio (HR)|10.0|STANDARD_ERROR_OF_MEAN|5.0|<|0.01|TWO_SIDED|95.0|||||Chi-squared|||||||<0.01
70910572|NCT00231179|141310732|NON_INFERIORITY_OR_EQUIVALENCE|See previous.|Hazard Ratio (HR)|3.0|STANDARD_ERROR_OF_MEAN|3.0|<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
70910573|NCT00231179|141310733|NON_INFERIORITY_OR_EQUIVALENCE|See previous.|Hazard Ratio (HR)|3.0|STANDARD_ERROR_OF_MEAN|3.0||0.64|TWO_SIDED|95.0|||||Chi-squared|||||||0.64
70910574|NCT02892409|141310739|EQUIVALENCE|LS Mean Ratio (TAK-438/Lansoprazole), 95 percent (%) confidence interval (CI) of the ratio were obtained by taking the anti-log of the difference or confidence limits of difference between the LS means of test and reference on the natural logarithmic scale.|Least Square (LS) Mean Ratio|105.1|||||TWO_SIDED|95.0|66.051|167.183||||||||167.183|66.051|
70910575|NCT02892409|141310740|EQUIVALENCE|LS Mean Ratio (TAK-438/Lansoprazole), 95% CI of the ratio were obtained by taking the anti-log of the difference or confidence limits of difference between the LS means of test and reference on the natural logarithmic scale.|LS Mean Ratio|93.6|||||TWO_SIDED|95.0|67.137|130.569||||||||130.569|67.137|
70910576|NCT02331940|141310742|SUPERIORITY_OR_OTHER|||||||0.88||||||p\<0.05 was considered statistically significant|t-test, 1 sided|||||||0.88
70910577|NCT00951561|141310785|NON_INFERIORITY_OR_EQUIVALENCE|The sample size calculation is performed in nQuery version 5.0 with the following stipulations: alpha is 0.05; response for both ibuprofen and Vipon is 85%; delta is 10%; no difference in response rates is expected between the two treatment arms, and power is 80%. This calculation is performed for an equivalence/non-inferiority primary analysis.|Difference in % of Uses from Mixed Model|-1.6|||<|0.05||95.0|||||Mixed Models Analysis|||||||<0.05
70910578|NCT02092987|141310786|SUPERIORITY_OR_OTHER_LEGACY||interaction term|||||0.7|||||||Mixed Models Analysis|||Hypothesis testing in changes in mean from baseline to follow-up were were conducted primarily with mixed models. Sensitivity analyses were conducted using ANOVA.||||0.70
71092197|NCT00855582|141690982|SUPERIORITY_OR_OTHER|||||||0.186||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Ranked ANOVA|||||||0.186
70910579|NCT02092987|141310787|SUPERIORITY_OR_OTHER_LEGACY|||||||0.77||||||comparison of arms using mixed models|Mixed Models Analysis|||||||0.77
70910580|NCT02092987|141310788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.51|||||||Mixed Models Analysis|||||||0.51
70910581|NCT02092987|141310789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.51|||||||Mixed Models Analysis|||||||0.51
70910582|NCT02092987|141310790|SUPERIORITY_OR_OTHER_LEGACY|||||||0.76|||||||Mixed Models Analysis|||||||0.76
70910583|NCT02092987|141310791|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79|||||||Mixed Models Analysis|||||||0.79
70910584|NCT02092987|141310792|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62|||||||Mixed Models Analysis|||||||0.62
70910585|NCT02373813|141310803|SUPERIORITY||Risk Difference (RD)|20.8|STANDARD_ERROR_OF_MEAN|6.7||0.004|TWO_SIDED|95.0|7.6|33.9||The risk difference and its p-value were estimated from the chi-squared test with continuity correction.|Chi-squared, Corrected|||||33.9|7.6|0.004
70910586|NCT02373813|141310804|SUPERIORITY||Risk Difference (RD)|24.2|STANDARD_ERROR_OF_MEAN|8.3||0.006|TWO_SIDED|95.0|7.9|40.5||The risk difference and its p-value were estimated from the chi-squared test with continuity correction.|Chi-squared, Corrected|||||40.5|7.9|0.006
70910587|NCT02373813|141310805|SUPERIORITY||Treatment Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.19||0.58|TWO_SIDED|95.0|-0.48|0.27|||two sample t-test|||Baseline||0.27|-0.48|0.58
71092198|NCT01588509|141690987|SUPERIORITY||Percent Change from Baseline|2.13||||0.002|TWO_SIDED|90.0|1.05|3.2|||ANOVA|||||3.20|1.05|0.002
70910588|NCT02373813|141310805|SUPERIORITY||Treatment Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.17||0.85|TWO_SIDED|95.0|-0.37|0.31|||two sample t-test|||Baseline||0.31|-0.37|0.85
70910589|NCT02373813|141310805|SUPERIORITY||Treatment Difference|-2.61|STANDARD_ERROR_OF_MEAN|1.66||0.12|TWO_SIDED|95.0|-5.89|0.67|||two sample t-test|||Week 12||0.67|-5.89|0.12
70910590|NCT02373813|141310805|SUPERIORITY||Treatment Difference|-2.64|STANDARD_ERROR_OF_MEAN|1.26||0.037|TWO_SIDED|95.0|-5.12|-0.16|||two sample t-test|||Week 12||-0.16|-5.12|0.037
70910591|NCT02373813|141310805|SUPERIORITY||Treatment Difference|-2.33|STANDARD_ERROR_OF_MEAN|1.46||0.063|TWO_SIDED|95.0|-4.8|0.13|||two sample t-test|||Week 24||0.13|-4.80|0.063
70910592|NCT02373813|141310805|SUPERIORITY||Treatment Difference|-0.63|STANDARD_ERROR_OF_MEAN|1.34||0.64|TWO_SIDED|95.0|-3.27|2.01|||two sample t-test|||Week 24||2.01|-3.27|0.64
70910593|NCT02373813|141310805|SUPERIORITY||Treatment Difference|-1.62|STANDARD_ERROR_OF_MEAN|0.9||0.031|TWO_SIDED|95.0|-3.09|-0.15|||two sample t-test|||Week 36||-0.15|-3.09|0.031
70910594|NCT02373813|141310805|SUPERIORITY||Treatment Difference|-1.77|STANDARD_ERROR_OF_MEAN|0.71||0.015|TWO_SIDED|95.0|-3.2|-0.35|||two sample t-test|||Week 36||-0.35|-3.20|0.015
71031665|NCT01993030|141572087|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED|||||Values of p \< 0.05 were considered to be significantly different.|Fisher Exact|||"Two-sided Fisher's exact test was performed to assess statistically significant differences of the data of the Number of Participants with Inflammatory Reaction between the group treated with the HQ® Matrix Medical Wound Dressing and that treated with the Sidaiyi® wound dressing.~This Statistical Analysis applies to the Participants with Inflammatory Reaction and the Participants without Inflammatory Reaction category."||||0.36
70910595|NCT02373813|141310805|SUPERIORITY||Treatment Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.87||0.58|TWO_SIDED|95.0|-2.55|1.45|||two sample t-test|||Week 48||1.45|-2.55|0.58
70910596|NCT02373813|141310805|SUPERIORITY||Treatment Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.45||0.02|TWO_SIDED|95.0|-1.99|-0.17|||two sample t-test|||Week 48||-0.17|-1.99|0.020
70910597|NCT02373813|141310806|SUPERIORITY||Treatment Difference|-2.46|STANDARD_ERROR_OF_MEAN|1.63||0.13|TWO_SIDED|95.0|-5.68|0.77|||two sample t-test|||Change at Week 12||0.77|-5.68|0.13
70910598|NCT02373813|141310806|SUPERIORITY||Treatment Difference|-2.53|STANDARD_ERROR_OF_MEAN|1.25||0.045|TWO_SIDED|95.0|-4.99|-0.06|||two sample t-test|||Change at Week 12||-0.06|-4.99|0.045
70910599|NCT02373813|141310806|SUPERIORITY||Treatment Difference|-2.27|STANDARD_ERROR_OF_MEAN|1.45||0.071|TWO_SIDED|95.0|-4.75|0.2|||two sample t-test|||Change at Week 24||0.20|-4.75|0.071
71031666|NCT01993030|141572088|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED|||||Values of p \< 0.05 were considered to be significantly different.|t-test, 2 sided|||Two-sided t-test was performed to assess statistically significant differences of the data of the VAS score between the group treated with the HQ® Matrix Medical Wound Dressing and that treated with the Sidaiyi® wound dressing.||||0.11
70910600|NCT02373813|141310806|SUPERIORITY||Treatment Difference|-0.64|STANDARD_ERROR_OF_MEAN|1.34||0.63|TWO_SIDED|95.0|-3.28|2.0|||two sample t-test|||Change at Week 24||2.00|-3.28|0.63
70910601|NCT02373813|141310806|SUPERIORITY||Treatment Difference|-1.61|STANDARD_ERROR_OF_MEAN|0.91||0.037|TWO_SIDED|95.0|-3.11|-0.1|||two sample t-test|||Change at Week 36||-0.10|-3.11|0.037
71092199|NCT01588509|141690987|SUPERIORITY||Percent Change from Baseline|2.08||||0.002|TWO_SIDED|90.0|1.02|3.14|||ANOVA|||||3.14|1.02|0.002
71092200|NCT01588509|141690988|SUPERIORITY||Percent Change from Baseline|2.06|||<|0.001|TWO_SIDED|90.0|1.07|3.05|||ANOVA|||||3.05|1.07|<0.001
70910602|NCT02373813|141310806|SUPERIORITY||Treatment Difference|-1.84|STANDARD_ERROR_OF_MEAN|0.73||0.013|TWO_SIDED|95.0|-3.3|-0.39|||two sample t-test|||Change at Week 36||-0.39|-3.30|0.013
70910603|NCT02373813|141310806|SUPERIORITY||Treatment Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.88||0.62|TWO_SIDED|95.0|-2.54|1.53|||two sample t-test|||Change at Week 48||1.53|-2.54|0.62
70910604|NCT02373813|141310806|SUPERIORITY||Treatment Difference|-1.12|STANDARD_ERROR_OF_MEAN|0.45||0.015|TWO_SIDED|95.0|-2.02|-0.22|||two sample t-test|||Change at Week 48||-0.22|-2.02|0.015
70910605|NCT02373813|141310807|SUPERIORITY||Treatment Difference|0.04|STANDARD_ERROR_OF_MEAN|0.11||0.75|TWO_SIDED|95.0|-0.19|0.26|||two sample t-test|||Baseline||0.26|-0.19|0.75
70910606|NCT02373813|141310807|SUPERIORITY||Treatment Difference|0.08|STANDARD_ERROR_OF_MEAN|0.1||0.43|TWO_SIDED|95.0|-0.11|0.27|||two sample t-test|||Baseline||0.27|-0.11|0.43
70910607|NCT02373813|141310807|SUPERIORITY||Treatment Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.23||0.049|TWO_SIDED|95.0|-0.91|0.0|||two sample t-test|||Week 12||0.00|-0.91|0.049
70910608|NCT02373813|141310807|SUPERIORITY||Treatment Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.032|TWO_SIDED|95.0|-0.77|-0.04|||two sample t-test|||Week 12||-0.04|-0.77|0.032
70910609|NCT02373813|141310807|SUPERIORITY||Treatment Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.2||0.18|TWO_SIDED|95.0|-0.58|0.11|||two sample t-test|||Week 24||0.11|-0.58|0.18
70910610|NCT02373813|141310807|SUPERIORITY||Treatment Difference|0.14|STANDARD_ERROR_OF_MEAN|0.19||0.48|TWO_SIDED|95.0|-0.24|0.51|||two sample t-test|||Week 24||0.51|-0.24|0.48
70910611|NCT02373813|141310807|SUPERIORITY||Treatment Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.17||0.35|TWO_SIDED|95.0|-0.51|0.18|||two sample t-test|||Week 36||0.18|-0.51|0.35
70910612|NCT02373813|141310807|SUPERIORITY||Treatment Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.13||0.28|TWO_SIDED|95.0|-0.41|0.12|||two sample t-test|||Week 36||0.12|-0.41|0.28
70910613|NCT02373813|141310807|SUPERIORITY||Treatment Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.16||0.48|TWO_SIDED|95.0|-0.44|0.21|||two sample t-test|||Week 48||0.21|-0.44|0.48
70910614|NCT02373813|141310807|SUPERIORITY||Treatment Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.13||0.92|TWO_SIDED|95.0|-0.26|0.24|||two sample t-test|||Week 48||0.24|-0.26|0.92
70910615|NCT02373813|141310808|SUPERIORITY||Treatment Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.22||0.032|TWO_SIDED|95.0|-0.91|-0.04|||two sample t-test|||Change at Week 12||-0.04|-0.91|0.032
70910616|NCT02373813|141310808|SUPERIORITY||Treatment Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.16||0.005|TWO_SIDED|95.0|-0.78|-0.15|||two sample t-test|||Change at Week 12||-0.15|-0.78|0.005
70910617|NCT02373813|141310808|SUPERIORITY||Treatment Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.18||0.058|TWO_SIDED|95.0|-0.63|0.01|||two sample t-test|||Change at Week 24||0.01|-0.63|0.058
70910618|NCT02373813|141310808|SUPERIORITY||Treatment Difference|0.05|STANDARD_ERROR_OF_MEAN|0.17||0.78|TWO_SIDED|95.0|-0.29|0.38|||two sample t-test|||Change at Week 24||0.38|-0.29|0.78
71092201|NCT01588509|141690988|SUPERIORITY||Percent Change from Baseline|1.92||||0.002|TWO_SIDED|90.0|0.95|2.89|||ANOVA|||||2.89|0.95|0.002
70910619|NCT02373813|141310808|SUPERIORITY||Treatment Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.16||0.27|TWO_SIDED|95.0|-0.49|0.14|||two sample t-test|||Change at Week 36||0.14|-0.49|0.27
70910620|NCT02373813|141310808|SUPERIORITY||Treatment Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.12||0.078|TWO_SIDED|95.0|-0.47|0.03|||two sample t-test|||Change at Week 36||0.03|-0.47|0.078
70910621|NCT02373813|141310808|SUPERIORITY||Treatment Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.16||0.47|TWO_SIDED|95.0|-0.43|0.2|||two sample t-test|||Week 48||0.20|-0.43|0.47
70910622|NCT02373813|141310808|SUPERIORITY||Treatment Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.39|TWO_SIDED|95.0|-0.33|0.13|||two sample t-test|||Change at Week 48||0.13|-0.33|0.39
70910623|NCT02373813|141310809|SUPERIORITY||Treatment Difference|0.03|STANDARD_ERROR_OF_MEAN|0.06||0.6|TWO_SIDED|95.0|-0.09|0.15|||two sample t-test|||Baseline||0.15|-0.09|0.60
70910624|NCT02373813|141310809|SUPERIORITY||Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.97|TWO_SIDED|95.0|-0.1|0.1|||two sample t-test|||Baseline||0.10|-0.10|0.97
70910625|NCT02373813|141310809|SUPERIORITY||Treatment Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.2||0.044|TWO_SIDED|95.0|-0.82|-0.01|||two sample t-test|||Week 12||-0.01|-0.82|0.044
70910626|NCT02373813|141310809|SUPERIORITY||Treatment Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.16||0.004|TWO_SIDED|95.0|-0.76|-0.14|||two sample t-test|||Week 12||-0.14|-0.76|0.004
70910627|NCT02373813|141310809|SUPERIORITY||Treatment Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.17||0.009|TWO_SIDED|95.0|-0.66|-0.1|||two sample t-test|||Week 24||-0.10|-0.66|0.009
70910628|NCT02373813|141310809|SUPERIORITY||Treatment Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.16||0.34|TWO_SIDED|95.0|-0.46|0.16|||two sample t-test|||Week 24||0.16|-0.46|0.34
70910629|NCT02373813|141310809|SUPERIORITY||Treatment Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.13||0.046|TWO_SIDED|95.0|-0.47|0.0|||two sample t-test|||Week 36||0.00|-0.47|0.046
70910630|NCT02373813|141310809|SUPERIORITY||Treatment Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.1||0.006|TWO_SIDED|95.0|-0.49|-0.08|||two sample t-test|||Week 36||-0.08|-0.49|0.006
71031667|NCT01993030|141572089|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED|||||Values of p \< 0.05 were considered to be significantly different.|Fisher Exact|||"Two-sided Fisher's exact test was performed to assess statistically significant differences of the data of the Number of Participants with Exudation between the group treated with the HQ® Matrix Medical Wound Dressing and that treated with the Sidaiyi® wound dressing.~This Statistical Analysis applies to No exudation and Little exudation category."||||0.11
71031668|NCT01993030|141572090|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Values of p \< 0.05 were considered to be significantly different.|t-test, 2 sided|||Two-sided t-test was performed to assess statistically significant differences of the data of the Time to Wound Healing between the group treated with the HQ® Matrix Medical Wound Dressing and that treated with the Sidaiyi® wound dressing.||||0.02
71031669|NCT03785548|141572091|OTHER||Mean Difference (Final Values)|2.851|STANDARD_ERROR_OF_MEAN|2.576||0.27|TWO_SIDED|95.0|-2.241|7.944|||ANCOVA|F(1, 140)=1.225||||7.944|-2.241|0.270
70910631|NCT02373813|141310809|SUPERIORITY||Treatment Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.13||0.25|TWO_SIDED|95.0|-0.4|-0.1|||two sample t-test|||Week 48||-0.10|-0.40|0.25
70910632|NCT02373813|141310809|SUPERIORITY||Treatment Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.021|TWO_SIDED|95.0|-0.37|-0.03|||two sample t-test|||Week 48||-0.03|-0.37|0.021
70910633|NCT02373813|141310810|SUPERIORITY||Treatment Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.2||0.03|TWO_SIDED|95.0|-0.82|-0.04|||two sample t-test|||Change at Week 12||-0.04|-0.82|0.030
70910634|NCT02373813|141310810|SUPERIORITY||Treatment Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.15||0.005|TWO_SIDED|95.0|-0.72|-0.13|||two sample t-test|||Change at Week 12||-0.13|-0.72|0.005
70910635|NCT02373813|141310810|SUPERIORITY||Treatment Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.16||0.002|TWO_SIDED|95.0|-0.69|-0.15|||two sample t-test|||Change at Week 24||-0.15|-0.69|0.002
70910636|NCT02373813|141310810|SUPERIORITY||Treatment Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.16||0.34|TWO_SIDED|95.0|-0.46|0.16|||two sample t-test|||Change at Week 24||0.16|-0.46|0.34
70910637|NCT02373813|141310810|SUPERIORITY||Treatment Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.13||0.014|TWO_SIDED|95.0|-0.52|-0.06|||two sample t-test|||Change at Week 36||-0.06|-0.52|0.014
70910638|NCT02373813|141310810|SUPERIORITY||Treatment Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.004|TWO_SIDED|95.0|-0.51|-0.1|||two sample t-test|||Change at Week 36||-0.10|-0.51|0.004
70910639|NCT02373813|141310810|SUPERIORITY||Treatment Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.12||0.12|TWO_SIDED|95.0|-0.43|0.05|||two sample t-test|||Change at Week 48||0.05|-0.43|0.12
70910640|NCT02373813|141310810|SUPERIORITY||Treatment Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.08||0.01|TWO_SIDED|95.0|-0.37|-0.05|||two sample t-test|||Change at Week 48||-0.05|-0.37|0.010
70910641|NCT02373813|141310811|SUPERIORITY||Treatment Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.067|TWO_SIDED|95.0|-0.62|0.02|||two sample t-test|||Baseline||0.02|-0.62|0.067
70910642|NCT02373813|141310811|SUPERIORITY||Treatment Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.16||0.59|TWO_SIDED|95.0|-0.41|0.23|||two sample t-test|||Baseline||0.23|-0.41|0.59
70910643|NCT02373813|141310811|SUPERIORITY||Treatment Difference|-2.46|STANDARD_ERROR_OF_MEAN|1.62||0.13||95.0|-5.66|0.74|||two sample t-test|||Week 12||0.74|-5.66|0.13
70910644|NCT02373813|141310811|SUPERIORITY||Treatment Difference|-2.34|STANDARD_ERROR_OF_MEAN|1.23||0.059|TWO_SIDED|95.0|-4.76|0.09|||two sample t-test|||Week 12||0.09|-4.76|0.059
70910645|NCT02373813|141310811|SUPERIORITY||Treatment Difference|-2.72|STANDARD_ERROR_OF_MEAN|1.38||0.017|TWO_SIDED|95.0|-4.95|-0.5|||two sample t-test|||Week 24||-0.50|-4.95|0.017
70910646|NCT02373813|141310811|SUPERIORITY||Treatment Difference|-0.44|STANDARD_ERROR_OF_MEAN|1.32||0.74|TWO_SIDED|95.0|-3.04|2.15|||two sample t-test|||Week 24||2.15|-3.04|0.74
70910647|NCT02373813|141310811|SUPERIORITY||Treatment Difference|-1.56|STANDARD_ERROR_OF_MEAN|0.9||0.039|TWO_SIDED|95.0|-3.03|-0.08|||two sample t-test|||Week 36||-0.08|-3.03|0.039
70910648|NCT02373813|141310811|SUPERIORITY||Treatment Difference|-1.66|STANDARD_ERROR_OF_MEAN|0.72||0.023|TWO_SIDED|95.0|-3.1|-0.23|||two sample t-test|||Week 36||-0.23|-3.10|0.023
70910649|NCT02373813|141310811|SUPERIORITY||Treatment Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.85||0.65|TWO_SIDED|95.0|-2.43|1.52|||two sample t-test|||Week 48||1.52|-2.43|0.65
71031670|NCT03785548|141572092|OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|3.098||0.964|TWO_SIDED|95.0|-5.983|6.266|||ANCOVA|F(1, 140)=0.002||||6.266|-5.983|0.964
71092202|NCT01588509|141690989|SUPERIORITY||Percent Change from Baseline|1.38|||<|0.001|TWO_SIDED|90.0|0.81|1.95|||ANOVA|||||1.95|0.81|<0.001
70910650|NCT02373813|141310811|SUPERIORITY||Treatment Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.44||0.017|TWO_SIDED|95.0|-1.94|-0.19|||two sample t-test|||Week 48||-0.19|-1.94|0.017
70910651|NCT02373813|141310812|SUPERIORITY||Treatment Difference|-2.15|STANDARD_ERROR_OF_MEAN|1.59||0.18||95.0|-5.29|1.0|||two sample t-test|||Change at Week 12||1.00|-5.29|0.18
70910652|NCT02373813|141310812|SUPERIORITY||Treatment Difference|-2.24|STANDARD_ERROR_OF_MEAN|1.21||0.067|TWO_SIDED|95.0|-4.63|0.16|||two sample t-test|||Change at Week 12||0.16|-4.63|0.067
70910653|NCT02373813|141310812|SUPERIORITY||Treatment Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.37||0.035|TWO_SIDED|95.0|-4.62|-0.17|||two sample t-test|||Change at Week 24||-0.17|-4.62|0.035
70910654|NCT02373813|141310812|SUPERIORITY||Treatment Difference|-0.34|STANDARD_ERROR_OF_MEAN|1.3||0.79|TWO_SIDED|95.0|-2.91|2.23|||two sample t-test|||Change at Week 24||2.23|-2.91|0.79
70910655|NCT02373813|141310812|SUPERIORITY||Treatment Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.91||0.09|TWO_SIDED|95.0|-2.75|0.2|||two sample t-test|||Change at Week 36||0.20|-2.75|0.090
70910656|NCT02373813|141310812|SUPERIORITY||Treatment Difference|-1.61|STANDARD_ERROR_OF_MEAN|0.72||0.029|TWO_SIDED|95.0|-3.06|-0.17|||two sample t-test|||Change at Week 36||-0.17|-3.06|0.029
70910657|NCT02373813|141310812|SUPERIORITY||Treatment Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.84||0.86|TWO_SIDED|95.0|-2.15|1.81|||two sample t-test|||Change at Week 48||1.81|-2.15|0.86
70910658|NCT02373813|141310812|SUPERIORITY||Treatment Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.43||0.021|TWO_SIDED|95.0|-1.88|-0.16|||two sample t-test|||Change at Week 48||-0.16|-1.88|0.021
70910659|NCT02373813|141310813|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|3.4||1|TWO_SIDED|95.0|-6.5|6.6||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Baseline||6.6|-6.5|1.00
70910660|NCT02373813|141310813|SUPERIORITY||Risk Difference (RD)|-3.9|STANDARD_ERROR_OF_MEAN|3.3||0.38|TWO_SIDED|95.0|-10.4|2.6||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Baseline||2.6|-10.4|0.38
70910661|NCT02373813|141310813|SUPERIORITY||Risk Difference (RD)|24.5|STANDARD_ERROR_OF_MEAN|7.9||0.007|TWO_SIDED|95.0|9.0|40.0|||Chi-squared, Corrected|||Week 12||40.0|9.0|0.007
71031671|NCT01710657|141572093|SUPERIORITY_OR_OTHER||% Reduction over Placebo|39.6|||<|0.001|TWO_SIDED|95.0|30.5|47.6||Significant at the 0.05 level. This testing procedure is considered a closed testing procedure and no adjustment of the significance level was necessary.|ANCOVA|||"To avoid inflation of Type I error, hypothesis testing followed predefined hierarchical procedure starting LCM 400 mg/day treatment group versus the placebo group.~If the test was not statistically significant, the procedure stopped and no Groups were declared different from placebo. If the test was statistically significant, the treatment group was considered different from placebo and the procedure continued with the LCM 200 mg/day treatment group."||47.6|30.5|<0.001
71031672|NCT01710657|141572093|SUPERIORITY_OR_OTHER||% Reduction over Placebo|29.4|||<|0.001|TWO_SIDED|95.0|18.7|38.7||Significant at the 0.05 level. This testing procedure is considered a closed testing procedure and no adjustment of the significance level was necessary.|ANCOVA|||"To avoid inflation of Type I error, hypothesis testing followed predefined hierarchical procedure starting LCM 400 mg/day treatment group versus the placebo group.~If the test was not statistically significant, the procedure stopped and no Groups were declared different from placebo. If the test was statistically significant, the treatment group was considered different from placebo and the procedure continued with the LCM 200 mg/day treatment group."||38.7|18.7|< 0.001
71031673|NCT01591785|141572113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035|TWO_SIDED||||||Chi-squared|||||||0.035
70910662|NCT02373813|141310813|SUPERIORITY||Risk Difference (RD)|14.0|STANDARD_ERROR_OF_MEAN|6.9||0.063|TWO_SIDED|95.0|0.4|27.6||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 12||27.6|0.4|0.063
70910663|NCT02373813|141310813|SUPERIORITY||Risk Difference (RD)|23.2|STANDARD_ERROR_OF_MEAN|8.4||0.012|TWO_SIDED|95.0|6.7|39.8|||Chi-squared, Corrected|||Week 24||39.8|6.7|0.012
70910664|NCT02373813|141310813|SUPERIORITY||Risk Difference (RD)|17.8|STANDARD_ERROR_OF_MEAN|7.0||0.018|TWO_SIDED|95.0|4.1|31.5||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 24||31.5|4.1|0.018
70910665|NCT02373813|141310813|SUPERIORITY||Risk Difference (RD)|19.0|STANDARD_ERROR_OF_MEAN|8.6||0.044|TWO_SIDED|95.0|2.1|35.9|||Chi-squared, Corrected|||Week 36||35.9|2.1|0.044
70910666|NCT02373813|141310813|SUPERIORITY||Risk Difference (RD)|19.5|STANDARD_ERROR_OF_MEAN|7.0||0.01|TWO_SIDED|95.0|5.8|33.2|||Chi-squared, Corrected|||Week 36||33.2|5.8|0.010
70910667|NCT02373813|141310813|SUPERIORITY||Risk Difference (RD)|25.7|STANDARD_ERROR_OF_MEAN|8.6||0.005|TWO_SIDED|95.0|8.9|42.5||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 48||42.5|8.9|0.005
70910668|NCT02373813|141310813|SUPERIORITY||Risk Difference (RD)|21.6|STANDARD_ERROR_OF_MEAN|7.0||0.004|TWO_SIDED|95.0|7.9|35.2||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 48||35.2|7.9|0.004
70910669|NCT02373813|141310814|SUPERIORITY||Risk Difference (RD)|11.1|STANDARD_ERROR_OF_MEAN|8.4||0.25|TWO_SIDED|95.0|-5.4|27.6||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Baseline||27.6|-5.4|0.25
70910670|NCT02373813|141310814|SUPERIORITY||Risk Difference (RD)|0.7|STANDARD_ERROR_OF_MEAN|6.7||1|TWO_SIDED|95.0|-12.5|13.8||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Baseline||13.8|-12.5|1.00
70910671|NCT02373813|141310814|SUPERIORITY||Risk Difference (RD)|1.6|STANDARD_ERROR_OF_MEAN|6.8||0.98|TWO_SIDED|95.0|-11.6|14.9||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 12||14.9|-11.6|0.98
71031674|NCT01591785|141572114|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28|TWO_SIDED||||||Chi-squared|||||||0.28
71031675|NCT01591785|141572115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0495|TWO_SIDED||||||Chi-squared|||||||0.0495
70910672|NCT02373813|141310814|SUPERIORITY||Risk Difference (RD)|5.0|STANDARD_ERROR_OF_MEAN|5.7||0.48|TWO_SIDED|95.0|-6.2|16.2||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 12||16.2|-6.2|0.48
70910673|NCT02373813|141310814|SUPERIORITY||Risk Difference (RD)|11.3|STANDARD_ERROR_OF_MEAN|7.3||0.16|TWO_SIDED|95.0|-3.1|25.7||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 24||25.7|-3.1|0.16
70910674|NCT02373813|141310814|SUPERIORITY||Risk Difference (RD)|1.4|STANDARD_ERROR_OF_MEAN|5.3||0.94|TWO_SIDED|95.0|-9.0|11.9||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 24||11.9|-9.0|0.94
70910675|NCT02373813|141310814|SUPERIORITY||Risk Difference (RD)|12.5|STANDARD_ERROR_OF_MEAN|7.4||0.12|TWO_SIDED|95.0|-2.1|27.0||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 36||27.0|-2.1|0.12
70910676|NCT02373813|141310814|SUPERIORITY||Risk Difference (RD)|5.8|STANDARD_ERROR_OF_MEAN|5.6||0.4|TWO_SIDED|95.0|-5.2|16.8||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 36||16.8|-5.2|0.40
70910677|NCT02373813|141310814|SUPERIORITY||Risk Difference (RD)|5.3|STANDARD_ERROR_OF_MEAN|7.7||0.63|TWO_SIDED|95.0|-9.8|20.4||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 48||20.4|-9.8|0.63
70910678|NCT02373813|141310814|SUPERIORITY||Risk Difference (RD)|-6.9|STANDARD_ERROR_OF_MEAN|5.7||0.31|TWO_SIDED|95.0|-18.0|4.2||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 48||4.2|-18.0|0.31
70910679|NCT02373813|141310816|SUPERIORITY||||||<|0.001||||||P-value was based on the Log-rank test for overall difference on disease-worsening event between two groups.|Log Rank|||||||< 0.001
70910680|NCT02373813|141310816|SUPERIORITY||||||<|0.001||||||P-value was based on the Log-rank test for overall difference on disease-worsening event between two groups.|Log Rank|||||||< 0.001
70910681|NCT02373813|141310817|SUPERIORITY|||||||0.31||||||P-value was based on the Log-rank test for overall difference on disease-worsening event between two groups.|Log Rank|||||||0.31
70910682|NCT02373813|141310817|SUPERIORITY|||||||0.51||||||P-value was based on the Log-rank test for overall difference on disease-worsening event between two groups.|Log Rank|||||||0.51
70910683|NCT02373813|141310818|SUPERIORITY||Risk Difference (RD)|12.5|STANDARD_ERROR_OF_MEAN|14.1||0.58|TWO_SIDED|95.0|-15.2|40.2|||Chi-squared, Corrected|||||40.2|-15.2|0.58
70910684|NCT02688621|141310885|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||The study was designed to detect a 2.2-kg group weight loss difference between groups with a standard deviation of 5.8 kg,4,5 a 5% Type I error rate, and 80% power. To adjust for possible clustering effects in this nested design, the adjusted variance estimate was increased to 7.67, calculated using a conservative intraclass correlation coefficient of 0.05.||||<.01
70910685|NCT00180674|141310905|SUPERIORITY|||||||0.043|||||||Wilcoxon Signed Ranks test|||||||0.043
70910686|NCT01106976|141310907|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0012||||0.0009|TWO_SIDED||||||t-test, 1 sided|||Paired t-test. Hypothesis of significant cholinergic interval changes over the study interval period.||||0.0009
70910687|NCT02851511|141310918|SUPERIORITY|tDCS vs. sham superiority with cognitive training will be tested based on the 320 participants who are assigned to the two cognitive training arms. The effects of tDCS on changes in NIH Toolbox Fluid Cognition Composite Score (NIHTB FCC) from baseline to 3-month follow-up are estimated by linear regression models, with missing outcomes predicted by regression models that include demographic and baseline characteristics.|Slope|0.33|STANDARD_ERROR_OF_MEAN|0.63|<|0.05|TWO_SIDED|95.0|-0.91|1.56||Formal statistical inference of the tDCS effect was based on the inverse-normal combination of two p-values, one from the Phase I data (N=42) and the other from the Phase II data (N=292).|Regression, Linear|||"Null hypothesis: The combination of cognitive training (12 weeks) and active stimulation (over the dorsolateral prefrontal cortex) will not lead to beneficial changes on the NIH Toolbox Cognition Battery.~The study is designed to have at least 90% power to detect a difference of effect size 0.42 between cognitive training+tDCS and cognitive training+sham, using a normal inverse combination test at one-sided 0.025 level."||1.56|-0.91|<0.05
70910688|NCT04003974|141310924|OTHER|Mean DUX4 activity was derived for each participant at each time point (Baseline and post-Baseline) based on normalized gene expression values for the 6-gene panel. Changes from Baseline to post-Baseline were analyzed using an ANCOVA model.|Least square mean difference|0.4284||||0.5621|TWO_SIDED|95.0|-1.0376|1.8945|||ANCOVA||Results are expressed as difference in Least-Squares (LS) means of the changes from Baseline to post-Baseline in DUX4 activity for each group, losmapimod and placebo.|||1.8945|-1.0376|0.5621
70910689|NCT00335153|141310954|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70910690|NCT00335153|141310955|SUPERIORITY_OR_OTHER|||||||0.023|||||||t-test, 2 sided|||||||0.023
70910691|NCT00335153|141310956|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70910692|NCT00335153|141310957|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70910693|NCT00335153|141310958|SUPERIORITY_OR_OTHER|||||||0.974|||||||t-test, 2 sided|||||||0.974
70910694|NCT00335153|141310959|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70910695|NCT00335153|141310960|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70910696|NCT00335153|141310961|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70910697|NCT00335153|141310962|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70910698|NCT00335153|141310963|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70910699|NCT00335153|141310964|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70910700|NCT00335153|141310965|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70910701|NCT00335153|141310966|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70910702|NCT00335153|141310967|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70910703|NCT00335153|141310968|SUPERIORITY_OR_OTHER|||||||0.757|||||||t-test, 2 sided|||||||0.757
70910704|NCT00335153|141310969|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70910705|NCT00335153|141310970|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70910706|NCT00335153|141310971|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70910707|NCT00335153|141310972|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70910708|NCT00335153|141310973|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70910709|NCT00335153|141310974|SUPERIORITY_OR_OTHER|||||||0.824|||||||t-test, 2 sided|||||||0.824
70910710|NCT02240680|141310980|SUPERIORITY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.81|-0.46|||Mixed Models Analysis|Mixed model repeated measures(MMRM) included treatment, week and interaction as fixed effects, baseline HbA1c, daily basal insulin dose as covariates|Adjusted mean of all differences between HbA1c at baseline and after 24 weeks. It is based on all patients in the model (not only patients with a baseline and week 24 measurement).||MMRM including fixed effects treatment , week and treatment by week interaction linear covariates baseline HbA1c , baseline daily basal insulin and baseline HbA1c by week interaction and random effect for patient. Within-patient errors are modelled by unstructured covariance matrix. Adjusted mean is based on all patients in the model (not only patients with a baseline and week 24 measurement).|-0.46|-0.81|< 0.0001
70910711|NCT02240680|141310981|OTHER||Odds Ratio (OR)|1.464|STANDARD_ERROR_OF_MEAN|0.397||0.1594|TWO_SIDED|95.0|0.861|2.491|||Regression, Logistic|A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.|The dispersion value standard error of the mean is actually standard error for odds ratio.|For any hypoglycemia event accompanied by prespecified glucose value||2.491|0.861|0.1594
70910712|NCT02240680|141310981|OTHER||Odds Ratio (OR)|1.149|STANDARD_ERROR_OF_MEAN|0.377||0.672|TWO_SIDED|95.0|0.604|2.188|||Regression, Logistic|A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.|The dispersion value standard error of the mean is actually standard error for odds ratio.|For glucose value \< 54mg/dL according American Diabetes Association definition of clinically significant hypoglycaemia||2.188|0.604|0.6720
70910713|NCT02240680|141310982|OTHER||Odds Ratio (OR)|5.018|STANDARD_ERROR_OF_MEAN|1.818|<|0.0001|TWO_SIDED|95.0|2.468|10.206|||Regression, Logistic|A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.|The dispersion value standard error of the mean is actually standard error of odds ratio|||10.206|2.468|< 0.0001
70910714|NCT02240680|141310983|OTHER||Odds Ratio (OR)|4.689|STANDARD_ERROR_OF_MEAN|1.519|<|0.0001|TWO_SIDED|95.0|2.485|8.848|||Regression, Logistic|A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.|The dispersion value standard error of the mean is actually standard error of odds ratio|||8.848|2.485|< 0.0001
70910715|NCT02240680|141310984|OTHER||Odds Ratio (OR)|3.731|STANDARD_ERROR_OF_MEAN|0.92|<|0.0001|TWO_SIDED|95.0|2.302|6.048|||Regression, Logistic|A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.|The dispersion value standard error of the mean is actually standard error of odds ratio|||6.048|2.302|< 0.0001
70910716|NCT02240680|141310985|SUPERIORITY||Mean Difference (Final Values)|-11.5|STANDARD_ERROR_OF_MEAN|4.8||0.0178|TWO_SIDED|95.0|-21.0|-2.0|||Mixed Models Analysis|Mixed model repeated measures(MMRM) included treatment, week and interaction as fixed effects, baseline HbA1c, FPG, daily insulin dose as covariates|Adjusted mean of all differences between HbA1c at baseline and after 24 weeks. It is based on all patients in the model (not only patients with a baseline and week 24 measurement).||MMRM including fixed effects treatment, week and treatment by week interaction, linear covariates baseline HbA1c, baseline daily basal insulin, baseline FPG and baseline FPG by week interaction and random effect for patient. Within-patient errors are modelled by unstructured covariance matrix. Adjusted mean is based on all patients in the model (not only patients with a baseline and week 24 measurement).|-2.0|-21.0|0.0178
70910717|NCT00483262|141311005|SUPERIORITY_OR_OTHER||>= grade 3 adverse event proportion|0.9|||||TWO_SIDED|90.0|0.72|0.98|||||Estimated proportion of patients with a adverse event of grade 3 or higher.|Single Arm Study||.98|.72|
70910718|NCT00483262|141311005|SUPERIORITY_OR_OTHER||toxicity grade >=3 proportion|0.79|||||TWO_SIDED|90.0|0.66|0.89|||||No comparison. Estimate the proportion of patients with grade 3 or higher toxicity.|Phase II toxicity||.89|.66|
70910719|NCT00483262|141311006|SUPERIORITY_OR_OTHER||response rate of PR or better|0.1|||||TWO_SIDED|90.0|0.02|0.28|||||Response of PR or better|Phase I part of this phase I/II study||.28|.02|
70910720|NCT00483262|141311006|SUPERIORITY_OR_OTHER||response rate of PR or better|0.33|||||TWO_SIDED|90.0|0.21|0.47|||||Response of PR or better|Phase II part of this phase I/II study.||0.47|0.21|
70910721|NCT00819234|141311016|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.23|STANDARD_ERROR_OF_MEAN|2.863||0.0135|TWO_SIDED|95.0|-12.93|-1.54|||t-test, 2 sided|||Treatment comparisons between each active treatment and placebo. Statistical tests performed two-sided at a significance level of α = 0.05. The null hypothesis tested was that there is no difference between each active treatment and the placebo treatment. The primary analysis did not incorporate any adjustment for multiple comparisons.||-1.54|-12.93|0.0135
71031676|NCT01591785|141572116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27|TWO_SIDED||||||Chi-squared|||||||0.27
70910722|NCT00819234|141311016|SUPERIORITY_OR_OTHER||LS Mean|-6.55|STANDARD_ERROR_OF_MEAN|2.681||0.0168|TWO_SIDED|95.0|-11.89|-1.21|||t-test, 2 sided|||Treatment comparisons between each active treatment and placebo. Statistical tests performed two-sided at a significance level of α = 0.05. The null hypothesis tested was that there is no difference between each active treatment and the placebo treatment. The primary analysis did not incorporate any adjustment for multiple comparisons||-1.21|-11.89|0.0168
70910723|NCT00819234|141311016|SUPERIORITY_OR_OTHER||LS Mean|-5.52|STANDARD_ERROR_OF_MEAN|2.887||0.0595|TWO_SIDED|95.0|-11.27|0.23|||t-test, 2 sided|||Treatment comparisons between each active treatment and placebo. Statistical tests performed two-sided at a significance level of α = 0.05. The null hypothesis tested was that there is no difference between each active treatment and the placebo treatment. The primary analysis did not incorporate any adjustment for multiple comparisons||0.23|-11.27|0.0595
71031677|NCT00358449|141572125|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55||||0.865|TWO_SIDED|95.0|0.04|5.44|||Regression, Logistic|||||5.44|0.04|0.865
71031678|NCT00358449|141572125|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.21||||0.19|TWO_SIDED|95.0|0.01|2.07|||Regression, Logistic|||||2.07|0.01|0.190
71031679|NCT00358449|141572128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128||||0.551|TWO_SIDED|95.0|-0.303|0.56|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.560|-0.303|0.551
70910724|NCT05174065|141311036|SUPERIORITY||Adjusted Difference in Proportion|32.6|||<|0.0001|TWO_SIDED|95.0|18.7|46.5|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors of rounded PPPASI total score range (≤ 20/21 to 30/≥ 31) and focal infection status (yes/no) at baseline.|Based on the Cochran-Mantel-Haenszel method adjusting for the stratification factors. The adjusted difference in proportion was the weighted average of the treatment differences across strata.|||46.5|18.7|<0.0001
70910725|NCT05174065|141311037|SUPERIORITY||Difference in Least Squares Mean|-6.13|||<|0.0001|TWO_SIDED|95.0|-8.57|-3.69|||MMRM|With treatment group, visit time, treatment-by-time interaction, and stratification factors as fixed effect, and the baseline value as a covariate.|Apremilast - Placebo|||-3.69|-8.57|<0.0001
70910726|NCT05174065|141311038|SUPERIORITY||Difference in Least Squares Mean|-1.5|||<|0.0001|TWO_SIDED|95.0|-2.2|-0.9|||MMRM|With treatment group, visit time, treatment-by-time interaction, and stratification factors as fixed effect, and baseline value as covariate.|Apremilast - Placebo|||-0.9|-2.2|<0.0001
70910727|NCT05174065|141311039|SUPERIORITY||Difference in Least Squares Mean|-7.8||||0.033|TWO_SIDED|95.0|-14.9|-0.6|||MMRM|With treatment group, visit time, treatment-by-time interaction, and stratification factors as fixed effect, and the baseline value as a covariate.|Apremilast - Placebo|||-0.6|-14.9|0.0330
70910728|NCT05174065|141311040|SUPERIORITY||Difference in Least Squares Mean|-10.8||||0.0076|TWO_SIDED|95.0|-18.6|-2.9|||MMRM|With treatment group, visit time, treatment-by-time interaction, and stratification factors as fixed effect, and the baseline value as a covariate.|Apremilast - Placebo|||-2.9|-18.6|0.0076
70910729|NCT05174065|141311041|SUPERIORITY||Difference in Least Squares Mean|-1.4||||0.0036|TWO_SIDED|95.0|-2.4|-0.5|||MMRM|With treatment group, visit time, treatment-by-time interaction, and stratification factors as fixed effect, and the baseline value as a covariate.|Apremilast - Placebo|||-0.5|-2.4|0.0036
70910730|NCT00216320|141311043|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<.001
70910731|NCT00924560|141311047|NON_INFERIORITY_OR_EQUIVALENCE|91-day levonorgestrel OC was declared to be non-inferior to the untreated control group if the lower bound of the 2-sided 95% confidence interval (CI) was greater than -3%.|LS Mean Difference|-0.23|||||TWO_SIDED|95.0|-0.67|0.2|||||Difference = OC group minus the untreated control|The primary efficacy endpoint (percent change from baseline to 12 months in lumbar spine BMD) was analyzed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.20|-0.67|
70910732|NCT00924560|141311047|NON_INFERIORITY_OR_EQUIVALENCE|28-day levonorgestrel OC was declared to be non-inferior to the untreated control group if the lower bound of the 2-sided 95% confidence interval (CI) was greater than -3%.|LS Mean Difference|-1.05|||||TWO_SIDED|95.0|-1.49|-0.61|||||Difference = OC group minus the untreated control|The primary efficacy endpoint (percent change from baseline to 12 months in lumbar spine BMD) was analyzed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.61|-1.49|
70910733|NCT00924560|141311048|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|0.0|0.01||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.01|-0.00|
70910734|NCT00924560|141311048|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.00|-0.01|
70910735|NCT00924560|141311048|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.00|-0.01|
71031680|NCT00358449|141572128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.593||95.0|-0.331|0.572|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.572|-0.331|0.593
70910736|NCT00924560|141311048|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.02|-0.01||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.01|-0.02|
70910737|NCT00924560|141311049|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17|||||TWO_SIDED|95.0|-0.08|0.42||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.42|-0.08|
70910738|NCT00924560|141311049|SUPERIORITY_OR_OTHER||LS mean Difference|-0.43|||||TWO_SIDED|95.0|-0.68|-0.18||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.18|-0.68|
70910739|NCT00924560|141311049|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07|||||TWO_SIDED|95.0|-0.39|0.24||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.24|-0.39|
70910740|NCT00924560|141311049|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.74|||||TWO_SIDED|95.0|-1.05|-0.42||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.42|-1.05|
71031681|NCT00358449|141572128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.334||||0.239|TWO_SIDED|95.0|-0.232|0.901|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.901|-0.232|0.239
71031682|NCT00358449|141572128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.211||||0.488|TWO_SIDED|95.0|-0.401|0.823|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.823|-0.401|0.488
70910741|NCT00924560|141311050|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|0.0|0.01||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.01|0.00|
70910742|NCT00924560|141311050|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.00|-0.01|
71031683|NCT00358449|141572129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.356||||0.139|TWO_SIDED|95.0|-0.121|0.833|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.833|-0.121|0.139
71031684|NCT00358449|141572129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.371||||0.145||95.0|-0.133|0.874|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.874|-0.133|0.145
70910743|NCT00924560|141311050|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|||||TWO_SIDED|95.0|0.0|0.01||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.01|0.00|
70910744|NCT00924560|141311050|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|0.95|-0.01|0.0||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.00|-0.01|
70910745|NCT00924560|141311051|SUPERIORITY_OR_OTHER||LS mean Difference|0.13|||||TWO_SIDED|95.0|-0.03|0.28||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.28|-0.03|
70910746|NCT00924560|141311051|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|||||TWO_SIDED|95.0|-0.2|0.11||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.11|-0.20|
70910747|NCT00924560|141311051|SUPERIORITY_OR_OTHER||LS Mean Difference|0.16|||||TWO_SIDED|95.0|-0.01|0.34||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.34|-0.01|
70910748|NCT00924560|141311051|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|||||TWO_SIDED|95.0|-0.32|0.03||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.03|-0.32|
70910749|NCT00924560|141311052|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.00|-0.01|
70910750|NCT00924560|141311052|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.00|-0.01|
70910751|NCT00924560|141311052|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.00|-0.01|
70910752|NCT00924560|141311052|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.00|-0.01|
70910753|NCT00924560|141311053|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.48|||||TWO_SIDED|95.0|-23.57|12.61||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||12.61|-23.57|
70910754|NCT00924560|141311053|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.55|||||TWO_SIDED|95.0|-25.65|10.55||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||10.55|-25.65|
71031685|NCT00358449|141572129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.433||||0.095|TWO_SIDED|95.0|-0.08|0.946|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.946|-0.080|0.095
70910755|NCT00924560|141311053|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.09|||||TWO_SIDED|95.0|-34.99|10.81||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||10.81|-34.99|
70910756|NCT00924560|141311053|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.17|||||TWO_SIDED|95.0|-44.08|1.74||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||1.74|-44.08|
70910757|NCT02909101|141311100|SUPERIORITY|||||||0.039|||||||ANCOVA|ANCOVAs were 2 (Arm) by 2 (Time). Covariates were age, WTAR standard score, and number of games improved (as a proxy of intervention engagement).||Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.||||0.039
71031686|NCT00358449|141572129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.343||||0.219|TWO_SIDED|95.0|-0.214|0.899|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.899|-0.214|0.219
70910758|NCT02909101|141311101|SUPERIORITY|||||||0.054|||||||ANCOVA|ANCOVAs were 2 (Arm) by 2 (Time). Covariates were age, WTAR standard score, and number of games improved (as a proxy of intervention engagement).||Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.||||0.054
70910759|NCT02909101|141311102|OTHER|||||||0.744|||||||t-test, 2 sided|||To determine acceptability, we examined whether mean ratings for both arms were above 3.5, and we also examined whether there was any difference between arms.||||0.744
70910760|NCT02909101|141311103|OTHER|||||||0.719|||||||t-test, 2 sided|||To determine acceptability in terms of helpfulness, we examined whether mean ratings for both arms were above 3.5, and we also examined whether there was any difference between arms.||||0.719
70910761|NCT02909101|141311104|SUPERIORITY|||||||0.337|||||||ANCOVA|ANCOVAs were 2 (Arm) by 2 (Time). Covariates were age, WTAR standard score, and number of games improved (as a proxy of intervention engagement).||Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.||||0.337
70910762|NCT02909101|141311105|SUPERIORITY|||||||0.025|||||||ANCOVA|ANCOVAs were 2 (Arm) by 2 (Time). Covariates were age, WTAR standard score, and number of games improved (as a proxy of intervention engagement).||Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.||||0.025
70910763|NCT02909101|141311106|SUPERIORITY|||||||0.133|||||||ANCOVA|ANCOVAs were 2 (Arm) by 2 (Time). Covariates were age, WTAR standard score, and number of games improved (as a proxy of intervention engagement).||Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.||||0.133
70910764|NCT01125774|141311107|SUPERIORITY_OR_OTHER||Difference in percent incidence|-1.2|||||TWO_SIDED|95.0|-4.4|2.1|||Miettinen & Nurminen||Telcagepant percent incidence versus Placebo percent incidence|||2.1|-4.4|
70910765|NCT01125774|141311108|SUPERIORITY_OR_OTHER||Difference in percent incidence|-0.2|||||TWO_SIDED|95.0|-1.4|0.8|||Miettinen & Nurminen||Telcagepant percent incidence versus Placebo percent incidence|||0.8|-1.4|
71031687|NCT00358449|141572130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.59||||0.832|TWO_SIDED|95.0|-13.47|16.65|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||16.65|-13.47|0.832
70910766|NCT01125774|141311109|SUPERIORITY_OR_OTHER||Difference in percent incidence|0.6|||||TWO_SIDED|95.0|-0.5|1.6|||Miettinen & Nurminen||Telcagepant percent incidence versus Placebo percent incidence|||1.6|-0.5|
70910767|NCT01125774|141311111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.13|TWO_SIDED|95.0|-1.1|0.1||α=0.0499|Longitudinal data analysis (LDA)||Difference is Telcagepant 140 mg versus Placebo|This measure tests the primary hypothesis, that telcagepant 140 mg is superior to placebo as measured by mean monthly headache days in participants with MRM or PMM||0.1|-1.1|0.130
70910768|NCT01125774|141311112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.369|TWO_SIDED|95.0|-1.0|0.4||To control Type I error, formal significance of the test for treatment difference for this measure could only be achieved if the comparison corresponding to the primary hypothesis was significant at α=0.0499|LDA||Difference is Telcagepant 140 mg versus Placebo|||0.4|-1.0|0.369
70910769|NCT01125774|141311113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.5|-0.2||To control Type I error, formal significance of the test for treatment difference for this measure could only be achieved if the comparison corresponding to the primary hypothesis was significant at α=0.0499|LDA||Difference is Telcagepant 140 mg versus Placebo|||-0.2|-0.5|<0.001
70910770|NCT01125774|141311114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||<|0.001|TWO_SIDED|95.0|-0.5|-0.2||To control Type I error, formal significance of the test for treatment difference for this measure could only be achieved if the comparison corresponding to the primary hypothesis was significant at α=0.0499|LDA||Difference is Telcagepant 140 mg versus Placebo|||-0.2|-0.5|<0.001
70910771|NCT01125774|141311115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.393|TWO_SIDED|95.0|-0.4|0.2||To control Type I error, formal significance of the test for treatment difference for this measure could only be achieved if the comparison corresponding to the primary hypothesis was significant at α=0.0499|LDA||Difference is Telcagepant 140 mg versus Placebo|||0.2|-0.4|0.393
70910772|NCT02337361|141311145|OTHER||||||||||||||||||Generalized estimating equations (GEE)(Diggle et al. 2002) tested e-SBI efficacy, controlling for demographic differences between study condition and study sites. GEE models estimate population average or marginal models and account for within-subject nonindependence (clustering) of observations across multiple waves of data collection and use all available data in model estimation.|||
70910773|NCT02337361|141311145|OTHER||||||||||||||||||Generalized estimating equations tested e-SBI efficacy, controlling for demographic differences between study condition and study sites. GEE models estimate population average or marginal models and account for within-subject nonindependence (clustering) of observations across multiple waves of data collection and use all available data in model estimation|||
70910774|NCT02337361|141311146|OTHER||Odds Ratio (OR)|0.22|STANDARD_ERROR_OF_MEAN|0.12|<|0.01|TWO_SIDED||||||t-test, 2 sided||the e-SBI group was at reduced odds relative to the control group to report weekly or more frequent drinking at 6 month follow-up||Generalized estimating equations (GEE) tested e-SBI efficacy, controlling for demographic differences between study condition and study sites. GEE models estimate population average or marginal models and account for within-subject nonindependence (clustering) of observations across multiple waves of data collection and use all available data in model estimation.|||<.01
70910775|NCT02337361|141311147|OTHER||Odds Ratio (OR)|0.23|STANDARD_ERROR_OF_MEAN|0.14|<|0.05|TWO_SIDED||||||t-test, 2 sided||the e-SBI group was at reduced odds relative to the control group to report drinking a maximum quantity of 5 or more drinks in a day at 6 month follow-up|||||<.05
70910776|NCT02337361|141311148|OTHER||Odds Ratio (OR)|0.51|STANDARD_ERROR_OF_MEAN|0.2|<|0.1|TWO_SIDED||||||t-test, 2 sided||the e-SBI group was at reduced odds relative to the control group to report any tobacco use at 6 month follow-up||Generalized estimating equations (GEE) tested e-SBI efficacy, controlling for demographic differences between study condition and study sites. GEE models estimate population average or marginal models and account for within-subject nonindependence (clustering) of observations across multiple waves of data collection and use all available data in model estimation.|||<.10
70910777|NCT02337361|141311149|OTHER||Odds Ratio (OR)|0.26|STANDARD_ERROR_OF_MEAN|0.15|<|0.01|TWO_SIDED||||||t-test, 2 sided||the e-SBI group was at reduced odds relative to the control group to report significant depression at 6 month follow-up|||||<.01
70910778|NCT02337361|141311150|OTHER||||||||||||||||||Generalized estimating equations (GEE) tested DrinkWise's effects on changes in depression over time controlling for demographic differences between study condition and study sites.|||
70910779|NCT02427646|141311162|OTHER|"A linear mixed effects (LME) model via the maximized likelihood estimation was implemented using open-source statistical software, R (version 3.3.3). The effects of each clinical and kinematic outcome measures were examined for each participant group (ET and PD arms were separately analyzed thus no interaction effects were investigated) in separate LME models (lme4 package using lmer function)."|||||<|0.05|||||||Linear mixed effects model|||||||<0.05
70910780|NCT02427646|141311163|OTHER|"A linear mixed effects (LME) model via the maximized likelihood estimation was implemented using open-source statistical software, R (version 3.3.3). The effects of each clinical and kinematic outcome measures were examined for each participant group (ET and PD arms were separately analyzed thus no interaction effects were investigated) in separate LME models (lme4 package using lmer function)."|||||<|0.05|||||||Linear mixed effects model|a log-transformation ofthe RMS datasets was applied for statistical analysis||||||<0.05
70910781|NCT00929305|141311175|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
70910782|NCT00929305|141311178|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
70910783|NCT01796665|141311179|EQUIVALENCE|provides 85% power of success|Equivalence ratio|96.57|||||TWO_SIDED|90.0|92.5|105.2|||Fieller's method|||||105.2|92.5|
70910784|NCT01796665|141311180|EQUIVALENCE|provides 85% power of success|Equivalence ratio|99.96|||||TWO_SIDED|90.0|92.9|110.5|||Fieller's method|||||110.5|92.9|
70910785|NCT01796665|141311181|EQUIVALENCE|provides 85% power of success|Equivalence ratio|-1.14|||||TWO_SIDED|90.0|-13.23|-1.13|||Fieller's method|||||-1.13|-13.23|
70910786|NCT03660943|141311188|SUPERIORITY||Mean Difference (Final Values)|-2.07|STANDARD_ERROR_OF_MEAN|1.192||0.0833|TWO_SIDED|95.0|-4.42|0.27|||Mixed Models Analysis|||The MMRM analysis included the change from study baseline in scores as the dependent variable, with terms for treatment, pooled study center, study baseline K-L grade category for the index knee, study baseline BMI category, study baseline OA type (unilateral or bilateral knee OA), sex, study visit, treatment by visit interaction, and study baseline score as covariates, using an unstructured covariance structure.||0.27|-4.42|0.0833
70910787|NCT03660943|141311189|SUPERIORITY|The number of NPRS subjects differed from the WOMAC outcomes because of differences in missing data.|Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.251||0.0935|TWO_SIDED|95.0|-0.91|0.07|||Mixed Models Analysis|||The MMRM analysis included the change from study baseline in scores as the dependent variable, with terms for treatment, pooled study center, study baseline K-L grade category for the index knee, study baseline BMI category, study baseline OA type (unilateral or bilateral knee OA), sex, study visit, treatment by visit interaction, and study baseline score as covariates, using an unstructured covariance structure.||0.07|-0.91|0.0935
70910788|NCT03660943|141311190|SUPERIORITY||Mean Difference (Final Values)|-1.22|STANDARD_ERROR_OF_MEAN|0.506||0.0163|TWO_SIDED|95.0|-2.22|-0.23|||Mixed Models Analysis|||The MMRM analysis included the change from study baseline in scores as the dependent variable, with terms for treatment, pooled study center, study baseline K-L grade category for the index knee, study baseline BMI category, study baseline OA type (unilateral or bilateral knee OA), sex, study visit, treatment by visit interaction, and study baseline score as covariates, using an unstructured covariance structure.||-0.23|-2.22|0.0163
70910789|NCT03660943|141311191|SUPERIORITY||Mean Difference (Final Values)|-7.99|STANDARD_ERROR_OF_MEAN|4.076||0.0509|TWO_SIDED|95.0|-16.01|0.03|||Mixed Models Analysis|||The MMRM analysis included the change from study baseline in scores as the dependent variable, with terms for treatment, pooled study center, study baseline K-L grade category for the index knee, study baseline BMI category, study baseline OA type (unilateral or bilateral knee OA), sex, study visit, treatment by visit interaction, and study baseline score as covariates, using an unstructured covariance structure.||0.03|-16.01|0.0509
70910790|NCT01345292|141311271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.44|STANDARD_ERROR_OF_MEAN|1.556|<|0.001|TWO_SIDED|95.0|8.37|14.5||If Sensodyne is better than Crest Regular (p\<0.05), testing would proceed to comparison of Wk 2 Mean Tactile Sensitivity Scores between Sensodyne and Crest Regular. Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||14.50|8.37|<0.001
70910791|NCT01345292|141311271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.33|STANDARD_ERROR_OF_MEAN|1.566|<|0.001|TWO_SIDED|95.0|5.24|11.42||If Potassium Oxalate Mouth Rinse is better than Crest Regular (p\<0.05), testing would proceed to comparison of Wk 2 Mean Tactile Sensitivity Scores between Potassium Oxalate Mouth Rinse and Crest Regular. Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||11.42|5.24|<0.001
70910792|NCT01345292|141311272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.05|STANDARD_ERROR_OF_MEAN|0.812|<|0.001|TWO_SIDED|95.0|1.45|4.65||The significance threshold level was 0.05 (two-sided). Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||4.65|1.45|<0.001
70910793|NCT01345292|141311272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.41|STANDARD_ERROR_OF_MEAN|0.818||0.004|TWO_SIDED|95.0|0.8|4.02||The significance threshold level was 0.05 (two-sided). Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||4.02|0.80|0.004
70910794|NCT01345292|141311273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|STANDARD_ERROR_OF_MEAN|2.091||0.324|TWO_SIDED|95.0|-6.19|2.06||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.06|-6.19|0.324
71031688|NCT00358449|141572130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.92||||0.622|TWO_SIDED|95.0|-12.01|19.84|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||19.84|-12.01|0.622
71031689|NCT00358449|141572130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.83||||0.317|TWO_SIDED|95.0|-11.86|35.52|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||35.52|-11.86|0.317
70850245|NCT02785770|141188258|SUPERIORITY_OR_OTHER||LS mean difference|0.09||||0.9034|TWO_SIDED|90.0|-1.08|1.25|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.25|-1.08|0.9034
70910795|NCT01345292|141311273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.43|STANDARD_ERROR_OF_MEAN|2.093||0.035|TWO_SIDED|95.0|-8.56|-0.31||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.31|-8.56|0.035
70910796|NCT01345292|141311274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.55|STANDARD_ERROR_OF_MEAN|2.551|<|0.001|TWO_SIDED|95.0|-13.6|-3.52||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-3.52|-13.6|<0.001
71031690|NCT00358449|141572130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.1||||0.246|TWO_SIDED|95.0|-10.91|41.11|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||41.11|-10.91|0.246
71031691|NCT00358449|141572131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.28||||0.046|TWO_SIDED|95.0|0.39|38.18|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||38.18|0.39|0.046
71031692|NCT00358449|141572131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.21||||0.16|TWO_SIDED|95.0|-5.83|34.25|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||34.25|-5.83|0.160
71031693|NCT00358449|141572131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.69||||0.078|TWO_SIDED|95.0|-2.1|37.48|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||37.48|-2.10|0.078
71031694|NCT00358449|141572131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.11||||0.055|TWO_SIDED|95.0|-0.51|42.74|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||42.74|-0.51|0.055
71031695|NCT00358449|141572132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.324||||0.241|TWO_SIDED|95.0|-0.226|0.873|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.873|-0.226|0.241
71092203|NCT01588509|141690989|SUPERIORITY||Percent Change from Baseline|1.4|||<|0.001|TWO_SIDED|90.0|0.84|1.96|||ANOVA|||||1.96|0.84|<0.001
71092204|NCT03345004|141690995|SUPERIORITY||Estimated ratio|1.091|||=|0.5009|TWO_SIDED|95.0|0.845|1.408|||Mixed Models Analysis|||||1.408|0.845|= 0.5009
71092205|NCT03345004|141690995|SUPERIORITY||Estimated ratio|1.557|||=|0.0078|TWO_SIDED|95.0|1.126|2.153|||Mixed Models Analysis|||||2.153|1.126|= 0.0078
71092206|NCT01013753|141691016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.097|0.182|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.182|0.097|<0.0001
71092207|NCT01013753|141691016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.14|0.224|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.224|0.140|<0.0001
71092208|NCT01013753|141691016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.205|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.163|0.248|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.248|0.163|<0.0001
71092209|NCT01013753|141691016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.229|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.186|0.272|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.272|0.186|<0.0001
71092210|NCT01013753|141691016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.126|0.211|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.211|0.126|<0.0001
71092211|NCT01013753|141691017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.163|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.116|0.211|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.211|0.116|<0.0001
71092212|NCT01013753|141691017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.212|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.166|0.259|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.259|0.166|<0.0001
71092213|NCT01013753|141691017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.233|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.186|0.28|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.280|0.186|<0.0001
71092214|NCT01013753|141691017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.203|0.298|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.298|0.203|<0.0001
71092215|NCT01013753|141691017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.137|0.231|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.231|0.137|<0.0001
71092216|NCT01013753|141691018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.073|0.158|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.158|0.073|<0.0001
71031696|NCT00358449|141572132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.371|TWO_SIDED|95.0|-0.32|0.839|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.839|-0.320|0.371
71092217|NCT01013753|141691018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.11|0.193|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.193|0.110|<0.0001
71092218|NCT01013753|141691018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.177|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.135|0.219|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.219|0.135|<0.0001
71031697|NCT00358449|141572132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.353||||0.291|TWO_SIDED|95.0|-0.317|1.023|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||1.023|-0.317|0.291
71092219|NCT01013753|141691018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.164|0.25|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.250|0.164|<0.0001
71092220|NCT01013753|141691018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.11|0.194|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.194|0.110|<0.0001
71092221|NCT01013753|141691019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.056|0.148|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.148|0.056|<0.0001
71092222|NCT01013753|141691019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.09|0.18|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.180|0.090|<0.0001
70910797|NCT01345292|141311274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.2|STANDARD_ERROR_OF_MEAN|2.553|<|0.001|TWO_SIDED|95.0|-15.2|-5.13||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-5.13|-15.2|<0.001
70910798|NCT01345292|141311275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.91|STANDARD_ERROR_OF_MEAN|2.271||0.032|TWO_SIDED|95.0|-9.38|-0.43||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.43|-9.38|0.032
70910799|NCT01345292|141311275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.42|STANDARD_ERROR_OF_MEAN|2.288||0.136|TWO_SIDED|95.0|-7.93|1.09||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.09|-7.93|0.136
70910800|NCT01345292|141311276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.2|STANDARD_ERROR_OF_MEAN|2.508|<|0.001|TWO_SIDED|95.0|-16.1|-6.23||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-6.23|-16.1|<0.001
70910801|NCT01345292|141311276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.2|STANDARD_ERROR_OF_MEAN|2.527|<|0.001|TWO_SIDED|95.0|-15.2|-5.25||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-5.25|-15.2|<0.001
70910802|NCT01345292|141311277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|2.012||0.533|TWO_SIDED|95.0|-5.22|2.71||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.71|-5.22|0.533
70910803|NCT01345292|141311277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|2.023||0.522|TWO_SIDED|95.0|-5.29|2.69||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.69|-5.29|0.522
70910804|NCT01345292|141311278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.53|STANDARD_ERROR_OF_MEAN|2.331|<|0.001|TWO_SIDED|95.0|-13.1|-3.94||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-3.94|-13.1|<0.001
70910805|NCT01345292|141311278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.13|STANDARD_ERROR_OF_MEAN|2.344||0.01|TWO_SIDED|95.0|-10.8|-1.51||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-1.51|-10.8|0.010
70910806|NCT01033643|141311283|OTHER||Accumulation or Geometric Mean Ratio|2.36|||||||||||||Accumulation ratio or geometric mean ratio (GMR) was calculated as last day of multiple dosing of MK-3614 (Day 10) divided by the first day of multiple dosing of MK-3614 (Day 1).|||||
70910807|NCT01033643|141311284|OTHER||Accumulation or Geometric Mean Ratio|1.62|||||||||||||Accumulation ratio or GMR was calculated as last day of multiple dosing of MK-3614 (Day 13) divided by the first day of multiple dosing of MK-3614 (Day 4).|||||
70910808|NCT01033643|141311286|OTHER||Accumulation or Geometric Mean Ratio|1.9|||||||||||||Accumulation ratio or GMR was calculated as last day of multiple dosing of MK-3614 (Day 10) divided by the first day of multiple dosing of MK-3614 (Day 1).|||||
70910809|NCT01033643|141311286|OTHER||Accumulation or Geometric Mean Ratio|1.63|||||||||||||Accumulation ratio or GMR was calculated as last day of multiple dosing of MK-3614 (Day 10) divided by the first day of multiple dosing of MK-3614 (Day 1).|||||
70910810|NCT01033643|141311287|OTHER||Accumulation or Geometric Mean Ratio|1.91|||||||||||||Accumulation ratio or GMR was calculated as last day of multiple dosing of MK-3614 (Day 10) divided by the first day of multiple dosing of MK-3614 (Day 1).|||||
71092223|NCT01013753|141691019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.116|0.207|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.207|0.116|<0.0001
70910811|NCT01033643|141311288|OTHER||Accumulation or Geometric Mean Ratio|1.38|||||||||||||Accumulation ratio or GMR was calculated as last day of multiple dosing of MK-3614 (Day 13) divided by the first day of multiple dosing of MK-3614 (Day 4).|||||
70910812|NCT01033643|141311295|OTHER|Linear Model|Mean Difference from Placebo|-4.17|||||TWO_SIDED|90.0|-9.53|1.2||||||||1.20|-9.53|
70910813|NCT01033643|141311295|OTHER|Linear Model|Mean Difference from Placebo|4.78|||||TWO_SIDED|90.0|-1.41|10.97||||||||10.97|-1.41|
70910814|NCT01033643|141311295|OTHER|Linear Model|Mean Difference from Placebo|-3.47|||||TWO_SIDED|90.0|-8.37|1.42||||||||1.42|-8.37|
70910815|NCT01033643|141311295|OTHER|Linear Model|Mean Difference from Placebo|3.53|||||TWO_SIDED|90.0|-1.37|8.42||||||||8.42|-1.37|
70910816|NCT01033643|141311296|OTHER|Linear Model|Mean Difference from Placebo|0.23|||||TWO_SIDED|90.0|-6.91|7.36||||||||7.36|-6.91|
70910817|NCT01033643|141311296|OTHER|Linear Model|Mean Difference from Placebo|-1.66|||||TWO_SIDED|90.0|-8.79|5.47||||||||5.47|-8.79|
70910818|NCT01033643|141311296|OTHER|Linear Model|Mean Difference from Placebo|2.11|||||TWO_SIDED|90.0|-5.02|9.25||||||||9.25|-5.02|
70910819|NCT01033643|141311296|OTHER|Linear Model|Mean Difference from Placebo|-1.23|||||TWO_SIDED|90.0|-9.41|6.94||||||||6.94|-9.41|
70910820|NCT01033643|141311297|OTHER|Linear Model|Mean Difference from Placebo|-0.75|||||TWO_SIDED|90.0|-9.29|7.79||||||||7.79|-9.29|
70910821|NCT01033643|141311297|OTHER|Linear Model|Mean Difference from Placebo|-3.73|||||TWO_SIDED|90.0|-14.32|6.86||||||||6.86|-14.32|
70910822|NCT01033643|141311297|OTHER|Linear Model|Mean Difference from Placebo|0.66|||||TWO_SIDED|90.0|-7.88|9.2||||||||9.20|-7.88|
70910823|NCT01033643|141311297|OTHER|Linear Model|Mean Difference from Placebo|-9.92|||||TWO_SIDED|90.0|-19.54|-0.3||||||||-0.30|-19.54|
70910824|NCT01033643|141311298|OTHER|Linear Model|Mean Difference from Placebo|-1.02|||||TWO_SIDED|90.0|-9.36|7.32||||||||7.32|-9.36|
70910825|NCT01033643|141311298|OTHER|Linear Model|Mean Difference from Placebo|-2.12|||||TWO_SIDED|90.0|-12.47|8.22||||||||8.22|-12.47|
70910826|NCT01033643|141311298|OTHER|Linear Model|Mean Difference from Placebo|-0.53|||||TWO_SIDED|90.0|-8.87|7.81||||||||7.81|-8.87|
70910827|NCT01033643|141311298|OTHER|Linear Model|Mean Difference from Placebo|-10.44|||||TWO_SIDED|90.0|-19.83|-1.04||||||||-1.04|-19.83|
70910828|NCT01033643|141311299|OTHER|Linear Model|Mean Difference from Placebo|-1.73|||||TWO_SIDED|90.0|-6.5|3.04||||||||3.04|-6.50|
70910829|NCT01033643|141311299|OTHER|Linear Model|Mean Difference from Placebo|-4.23|||||TWO_SIDED|90.0|-9.0|0.54||||||||0.54|-9.00|
70910830|NCT01033643|141311299|OTHER|Linear Model|Mean Difference from Placebo|-1.05|||||TWO_SIDED|90.0|-5.82|3.72||||||||3.72|-5.82|
70910831|NCT01033643|141311299|OTHER|Linear Model|Mean Difference from Placebo|-2.0|||||TWO_SIDED|90.0|-3.46|7.46||||||||7.46|-3.46|
70910832|NCT01033643|141311300|OTHER|Linear Model|Mean Difference from Placebo|-3.87|||||TWO_SIDED|90.0|-9.37|1.64||||||||1.64|-9.37|
70910833|NCT01033643|141311300|OTHER|Linear Model|Mean Difference from Placebo|-7.2|||||TWO_SIDED|90.0|-14.03|-0.37||||||||-0.37|-14.03|
70910834|NCT01033643|141311300|OTHER|Linear Model|Mean Difference from Placebo|-1.33|||||TWO_SIDED|90.0|-6.83|4.18||||||||4.18|-6.83|
70910835|NCT01033643|141311300|OTHER|Linear Model|Mean Difference from Placebo|-2.24|||||TWO_SIDED|90.0|-8.45|3.96||||||||3.96|-8.45|
70910836|NCT01033643|141311301|OTHER|Linear Model|Mean Difference from Placebo|-2.74|||||TWO_SIDED|90.0|-7.92|2.43||||||||2.43|-7.92|
70910837|NCT01033643|141311301|OTHER|Linear Model|Mean Difference from Placebo|-6.67|||||TWO_SIDED|90.0|-13.09|-0.25||||||||-0.25|-13.09|
70910838|NCT01033643|141311301|OTHER|Linear Model|Mean Difference from Placebo|-0.74|||||TWO_SIDED|90.0|-5.91|4.44||||||||4.44|-5.91|
70910839|NCT01033643|141311301|OTHER|Linear Model|Mean Difference from Placebo|-2.81|||||TWO_SIDED|90.0|-8.64|3.02||||||||3.02|-8.64|
71031698|NCT00358449|141572132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.176||||0.653|TWO_SIDED|95.0|-0.965|0.614|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.614|-0.965|0.653
70910840|NCT01033643|141311302|OTHER|Linear Model|Geometric Mean Ratio (GMR)|0.94|||||TWO_SIDED|90.0|0.47|1.87|||||GMR was calculated as MK-3614 Dose divided by Placebo|||1.87|0.47|
70910841|NCT01033643|141311302|OTHER|Linear Model|Geometric Mean Ratio (GMR)|0.48|||||TWO_SIDED|90.0|0.26|0.87|||||GMR was calculated as MK-3614 Dose divided by Placebo|||0.87|0.26|
70910842|NCT01033643|141311302|OTHER|Linear Model|Geometric Mean Ratio (GMR)|0.95|||||TWO_SIDED|90.0|0.51|1.79|||||GMR was calculated as MK-3614 Dose divided by Placebo|||1.79|0.51|
70910843|NCT01161160|141311316|NON_INFERIORITY|Equivalence criteria were fulfilled if the 2-sided 95% confidence limits on the geometric mean titer (GMT) ratio was within the interval 0.5 to 2.0.|Adjusted GMT ratio|0.96|||||TWO_SIDED|95.0|0.73|1.26||||||To demonstrate the immunological equivalence of HA antigen adjuvanted with AS03B manufactured in Quebec (Arepanrix™) and HA antigen adjuvanted with AS03B manufactured in Dresden (Pandemrix™), 21 days after vaccination.||1.26|0.73|
70910844|NCT00495469|141311338|OTHER|Tukey's trend test for dose response||||||0.003||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05|ANCOVA|Change=Baseline+Treatment||||||0.003
70910845|NCT00495469|141311338|OTHER|Tukey's trend test for dose response||||||0.047||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05.|ANCOVA|Change=Baseline+Treatment||||||0.047
70910846|NCT00495469|141311338|OTHER|Tukey's trend test for dose response||||||0.006||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05.|ANCOVA|Change=Baseline+Treatment||||||0.006
70910847|NCT00495469|141311338|OTHER|Tukey's trend test for dose response||||||0.085||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05.|ANCOVA|Change=Baseline+Treatment||||||0.085
70910848|NCT00495469|141311338|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34||||0.085|TWO_SIDED|95.0|-0.73|0.05||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||0.05|-0.73|0.085
70910849|NCT00495469|141311338|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56||||0.006|TWO_SIDED|95.0|-0.95|-0.16||Pairwise comparison included for informational purposes and not controlled for multiplicity|ANCOVA|Change=Baseline+Treatment||||-0.16|-0.95|0.006
70910850|NCT00495469|141311338|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34||||0.084|TWO_SIDED|95.0|-0.73|0.05||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||0.05|-0.73|0.084
70910851|NCT00495469|141311338|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.66||||0.001|TWO_SIDED|95.0|-1.05|-0.28||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-0.28|-1.05|0.001
70910852|NCT00495469|141311338|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59||||0.003|TWO_SIDED|95.0|-0.97|-0.2||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-0.20|-0.97|0.003
70910853|NCT00495469|141311338|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19||||0.337|TWO_SIDED|95.0|-0.58|0.2||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||0.20|-0.58|0.337
70910854|NCT00495469|141311340|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.85||||0.039|TWO_SIDED|95.0|-1.67|-0.04||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-0.04|-1.67|0.039
70910855|NCT00495469|141311340|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.06||||0.013|TWO_SIDED|95.0|-1.89|-0.23||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-0.23|-1.89|0.013
71031699|NCT00358449|141572133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.06||||0.123|TWO_SIDED|95.0|-4.0|32.13|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||32.13|-4.00|0.123
70910856|NCT00495469|141311340|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64||||0.131|TWO_SIDED|95.0|-1.46|0.19||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||0.19|-1.46|0.131
70910857|NCT00495469|141311340|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.95||||0.023|TWO_SIDED|95.0|-1.77|-0.13||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-0.13|-1.77|0.023
70910858|NCT00495469|141311340|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.13||||0.007|TWO_SIDED|95.0|-1.95|-0.32||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-0.32|-1.95|0.007
70910859|NCT00495469|141311340|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51||||0.223|TWO_SIDED|95.0|-1.34|0.32||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||0.32|-1.34|0.223
70910860|NCT00495469|141311341|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.1||||0.005|TWO_SIDED|95.0|-40.9|-7.4||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-7.4|-40.9|0.005
70910861|NCT00495469|141311341|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-35.0|||<|0.001|TWO_SIDED|95.0|-52.5|-17.4||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-17.4|-52.5|<0.001
70910862|NCT00495469|141311341|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.8||||0.001|TWO_SIDED|95.0|-46.9|-12.7||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-12.7|-46.9|0.001
70910863|NCT00495469|141311341|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-36.5|||<|0.001|TWO_SIDED|95.0|-53.6|-19.5||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-19.5|-53.6|<0.001
70910864|NCT00495469|141311341|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.5||||0.001|TWO_SIDED|95.0|-46.3|-12.7||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-12.7|-46.3|0.001
70910865|NCT00495469|141311341|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.8||||0.114|TWO_SIDED|95.0|-31.0|3.4||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||3.4|-31.0|0.114
70910866|NCT00495469|141311342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.757|TWO_SIDED|95.0|0.27|6.06||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (\<=6.5%)||6.06|0.27|0.757
70910867|NCT00495469|141311342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.58|TWO_SIDED|95.0|0.31|8.01||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (\<=6.5%)||8.01|0.31|0.580
70910868|NCT00495469|141311342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13||||0.881|TWO_SIDED|95.0|0.22|5.73||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 500 mg QD: Responders (\<=6.5%)||5.73|0.22|0.881
70910869|NCT00495469|141311342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.95||||0.382|TWO_SIDED|95.0|0.44|8.75||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (\<=6.5%)||8.75|0.44|0.382
70910870|NCT00495469|141311342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9||||0.409|TWO_SIDED|95.0|0.42|8.68||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (\<=6.5%)||8.68|0.42|0.409
70910871|NCT00495469|141311342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.795|TWO_SIDED|95.0|0.24|6.29||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (\<=6.5%)||6.29|0.24|0.795
70910872|NCT00495469|141311342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.765|TWO_SIDED|95.0|0.36|3.95||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (\<7%)||3.95|0.36|0.765
70910873|NCT00495469|141311342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.74||||0.1|TWO_SIDED|95.0|0.82|9.09||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (\<7%)||9.09|0.82|0.100
70910874|NCT00495469|141311342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.687|TWO_SIDED|95.0|0.38|4.3||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 500 mg QD: Responders (\<7%)||4.30|0.38|0.687
70910875|NCT00495469|141311342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.409|TWO_SIDED|95.0|0.5|5.52||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (\<7%)||5.52|0.50|0.409
70910876|NCT00495469|141311342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.81||||0.086|TWO_SIDED|95.0|0.86|9.15||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (\<7%)||9.15|0.86|0.086
70910877|NCT00495469|141311342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.369|TWO_SIDED|95.0|0.52|5.88||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (\<7%)||5.88|0.52|0.369
70910878|NCT00495469|141311342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.16|TWO_SIDED|95.0|0.74|6.4||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (reduction\>=0.7%)||6.40|0.74|0.160
70910879|NCT00495469|141311342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.87||||0.014|TWO_SIDED|95.0|1.31|11.42||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (reduction\>=0.7%)||11.42|1.31|0.014
70910880|NCT00495469|141311342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.162|TWO_SIDED|95.0|0.73|6.44||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (reduction\>=0.7%)||6.44|0.73|0.162
70910881|NCT00495469|141311342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.09||||0.011|TWO_SIDED|95.0|1.38|12.17||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (reduction\>=0.7%)||12.17|1.38|0.011
70910882|NCT00495469|141311342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.31||||0.003|TWO_SIDED|95.0|1.79|15.73||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (reduction\>=0.7%)||15.73|1.79|0.003
70910883|NCT00495469|141311342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.86||||0.264|TWO_SIDED|95.0|0.63|5.49||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (reduction\>=0.7%)||5.49|0.63|0.264
70910884|NCT00495469|141311343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.48|TWO_SIDED|95.0|0.46|5.28||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (\<7 mmol/L)||5.28|0.46|0.480
71031700|NCT00358449|141572133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.62||||0.551|TWO_SIDED|95.0|-13.29|24.54|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||24.54|-13.29|0.551
71031701|NCT00358449|141572133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.04||||0.141|TWO_SIDED|95.0|-5.61|37.7|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||37.70|-5.61|0.141
71092224|NCT01013753|141691019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.134|0.226|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.226|0.134|<0.0001
71092225|NCT01013753|141691019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.12|0.211|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.211|0.120|<0.0001
71092226|NCT01013753|141691020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.058|0.148|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.148|0.058|<0.0001
71092227|NCT01013753|141691020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.088|0.177|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.177|0.088|<0.0001
71092228|NCT01013753|141691020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.124|0.214|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.214|0.124|<0.0001
71092229|NCT01013753|141691020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.199|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.153|0.244|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.244|0.153|<0.0001
71092230|NCT01013753|141691020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.058|0.147|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.147|0.058|<0.0001
71092231|NCT01013753|141691021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.052|0.154|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.154|0.052|<0.0001
71092232|NCT01013753|141691021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.106|0.207|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.207|0.106|<0.0001
71092233|NCT01013753|141691021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.091|0.192|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.192|0.091|<0.0001
71092234|NCT01013753|141691021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.118|0.221|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.221|0.118|<0.0001
71092235|NCT01013753|141691021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.051|0.153|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.153|0.051|<0.0001
71092236|NCT01013753|141691022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.024||0.0107||95.0|0.014|0.107|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.107|0.014|0.0107
71031702|NCT00358449|141572133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.42||||0.666|TWO_SIDED|95.0|-30.74|19.9|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||19.90|-30.74|0.666
71031703|NCT00358449|141572134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088||||0.572|TWO_SIDED|95.0|-0.224|0.4|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.400|-0.224|0.572
71092237|NCT01013753|141691022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.069|0.16|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.160|0.069|<0.0001
71092238|NCT01013753|141691022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.069|0.161|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.161|0.069|<0.0001
70850246|NCT02785770|141188258|SUPERIORITY_OR_OTHER||LS mean difference|-0.68||||0.3391|TWO_SIDED|90.0|-1.85|0.49|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.49|-1.85|0.3391
71031704|NCT00358449|141572134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012||||0.942|TWO_SIDED|95.0|-0.35|0.326|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.326|-0.350|0.942
71092239|NCT01013753|141691022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.098|0.191|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.191|0.098|<0.0001
71092240|NCT01013753|141691022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.024||0.0001||95.0|0.044|0.137|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.137|0.044|0.0001
71031705|NCT00358449|141572134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005||||0.96|TWO_SIDED|95.0|-0.188|0.197|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.197|-0.188|0.960
71031706|NCT00358449|141572134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105||||0.317|TWO_SIDED|95.0|-0.105|0.315|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.315|-0.105|0.317
71031707|NCT00358449|141572135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13||||0.666|TWO_SIDED|95.0|-6.39|4.12|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||4.12|-6.39|0.666
71031708|NCT00358449|141572135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.16||||0.45|TWO_SIDED|95.0|-7.87|3.56|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||3.56|-7.87|0.450
71031709|NCT00358449|141572135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6||||0.215|TWO_SIDED|95.0|-12.0|2.81|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||2.81|-12.00|0.215
71031710|NCT00358449|141572135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.898|TWO_SIDED|95.0|-8.61|7.58|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||7.58|-8.61|0.898
71031711|NCT00358449|141572136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038||||0.762|TWO_SIDED|95.0|-0.217|0.294|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.294|-0.217|0.762
71031712|NCT00358449|141572136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.159||||0.235|TWO_SIDED|95.0|-0.426|0.108|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.108|-0.426|0.235
71031713|NCT00358449|141572136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089||||0.607|TWO_SIDED|95.0|-0.259|0.436|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.436|-0.259|0.607
71031714|NCT00358449|141572136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068||||0.716|TWO_SIDED|95.0|-0.308|0.443|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.443|-0.308|0.716
71031715|NCT00358449|141572137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.691|TWO_SIDED|95.0|-0.365|0.545|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.545|-0.365|0.691
71031716|NCT00358449|141572137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.161||||0.5|TWO_SIDED|95.0|-0.639|0.317|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.317|-0.639|0.500
71031717|NCT00358449|141572137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.187||||0.568|TWO_SIDED|95.0|-0.474|0.849|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.849|-0.474|0.568
71031718|NCT00358449|141572137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.076||||0.832|TWO_SIDED|95.0|-0.643|0.794|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.794|-0.643|0.832
71031719|NCT00358449|141572138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||0.515|TWO_SIDED|95.0|-3.45|1.76|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||1.76|-3.45|0.515
71031720|NCT00358449|141572138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.496|TWO_SIDED|95.0|-1.74|3.54|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||3.54|-1.74|0.496
71031721|NCT00358449|141572138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05||||0.657|TWO_SIDED|95.0|-5.82|3.72|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||3.72|-5.82|0.657
71031722|NCT00358449|141572138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.691|TWO_SIDED|95.0|-6.11|4.09|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||4.09|-6.11|0.691
71031723|NCT00358449|141572139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.142|TWO_SIDED|95.0|-0.105|0.704|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.704|-0.105|0.142
71031724|NCT00358449|141572139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.354||||0.115|TWO_SIDED|95.0|-0.09|0.798|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.798|-0.090|0.115
71031725|NCT00358449|141572139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182||||0.465|TWO_SIDED|95.0|-0.319|0.683|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.683|-0.319|0.465
71031726|NCT00358449|141572139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121||||0.649|TWO_SIDED|95.0|-0.417|0.66|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.660|-0.417|0.649
70910885|NCT00495469|141311343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.87||||0.011|TWO_SIDED|95.0|1.44|16.46||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (\<7 mmol/L)||16.46|1.44|0.011
71031727|NCT00358449|141572140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.077|TWO_SIDED|95.0|-0.042|0.782|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.782|-0.042|0.077
71031728|NCT00358449|141572140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.356||||0.12|TWO_SIDED|95.0|-0.097|0.809|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.809|-0.097|0.120
71031729|NCT00358449|141572140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.345|TWO_SIDED|95.0|-0.326|0.906|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.906|-0.326|0.345
71031730|NCT00358449|141572140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128||||0.7|TWO_SIDED|95.0|-0.541|0.798|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.798|-0.541|0.700
71031731|NCT00358449|141572141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.79||||0.609|TWO_SIDED|95.0|-8.79|5.22|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||5.22|-8.79|0.609
71031732|NCT00358449|141572141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59||||0.882|TWO_SIDED|95.0|-8.55|7.38|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||7.38|-8.55|0.882
71031733|NCT00358449|141572141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.595|TWO_SIDED|95.0|-7.68|4.47|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||4.47|-7.68|0.595
71031734|NCT00358449|141572141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.895|TWO_SIDED|95.0|-7.34|6.44|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||6.44|-7.34|0.895
71031735|NCT00358449|141572142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.513||||0.062|TWO_SIDED|95.0|-0.028|1.055|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||1.055|-0.028|0.062
71031736|NCT00358449|141572142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.241||||0.425|TWO_SIDED|95.0|-0.369|0.852|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.852|-0.369|0.425
71031737|NCT00358449|141572142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71||||0.082|TWO_SIDED|95.0|-0.096|1.516|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||1.516|-0.096|0.082
71031738|NCT00358449|141572142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.564|TWO_SIDED|95.0|-0.631|1.132|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||1.132|-0.631|0.564
71031739|NCT00358449|141572143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.45||||0.27|TWO_SIDED|95.0|-7.77|26.67|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||26.67|-7.77|0.270
71031740|NCT00358449|141572143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.12||||0.664|TWO_SIDED|95.0|-15.11|23.36|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||23.36|-15.11|0.664
71031741|NCT00358449|141572143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.57||||0.381|TWO_SIDED|95.0|-13.81|34.94|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||34.94|-13.81|0.381
71031742|NCT00358449|141572143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.49||||0.672|TWO_SIDED|95.0|-20.87|31.86|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||31.86|-20.87|0.672
71031743|NCT00358449|141572144|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Cochran-Mantel-Haenszel|||||||0.400
71031744|NCT00358449|141572144|SUPERIORITY_OR_OTHER|||||||0.111||95.0|||||Cochran-Mantel-Haenszel|||||||0.111
71031745|NCT00358449|141572145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.3||||0.421|TWO_SIDED|95.0|-71.1|34.4|||van Elteren test||P-value, 95% CI, and Estimated value are presented for Change from Baseline at Week 12|||34.4|-71.1|0.421
71031746|NCT00358449|141572145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.633|TWO_SIDED|95.0|-44.6|40.5|||van Elteren test||P-value, 95% CI, and Estimated value are presented for Change from Baseline at Week 12|||40.5|-44.6|0.633
71031747|NCT00358449|141572145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3||||0.92|TWO_SIDED|95.0|-76.3|45.7|||van Elteren test||P-value, 95% CI, and Estimated value are presented for Change from Baseline at Week 24|||45.7|-76.3|0.920
71031748|NCT00358449|141572145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.8||||0.105|TWO_SIDED|95.0|-79.2|11.6|||van Elteren test||P-value, 95% CI, and Estimated value are presented for Change from Baseline at Week 24|||11.6|-79.2|0.105
70910886|NCT00495469|141311343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.92||||0.087|TWO_SIDED|95.0|0.85|9.96||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 500 mg QD: Responders (\<7 mmol/L)||9.96|0.85|0.087
70910887|NCT00495469|141311343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.92||||0.082|TWO_SIDED|95.0|0.87|9.78||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (\<7 mmol/L)||9.78|0.87|0.082
71031749|NCT00358449|141572146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.63||||0.747|TWO_SIDED|95.0|-20.68|15.41|||van Elteren test||P-value, 95% CI, and Estimated value are presented for change from baseline values at Week 12|||15.41|-20.68|0.747
71031750|NCT00358449|141572146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7||||0.352|TWO_SIDED|95.0|-24.41|11.01|||van Elteren test||P-value, 95% CI, and Estimated value are presented for change from baseline values at Week 12|||11.01|-24.41|0.352
71031751|NCT00358449|141572146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.25||||0.525|TWO_SIDED|95.0|-29.69|11.2|||van Elteren test||P-value, 95% CI, and Estimated value are presented for change from baseline values at Week 24|||11.20|-29.69|0.525
71031752|NCT00358449|141572146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.79||||0.071|TWO_SIDED|95.0|-35.21|-0.38|||Van Elteren test||P-value, 95% CI, and Estimated value are presented for change from baseline at week 24|||-0.38|-35.21|0.071
71031753|NCT01375660|141572172|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED||||||ANOVA|||||||0.026
71031754|NCT01375660|141572173|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||ANOVA|||||||0.6
71031755|NCT01375660|141572174|SUPERIORITY_OR_OTHER|||||||0.389|TWO_SIDED||||||ANOVA|||||||0.389
71031756|NCT01375660|141572175|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED|||||P Value for Insulinogenic Index-30 = 0.34|ANOVA|||||||0.34
71031757|NCT01375660|141572176|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||ANOVA|||||||0.22
71031758|NCT01375660|141572177|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Chi-squared|||||||0.13
71031759|NCT01375660|141572178|SUPERIORITY_OR_OTHER|||||||0.869|TWO_SIDED||||||Chi-squared|||||||0.869
71031760|NCT00909610|141572192|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|92.3|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125|||111|92.3|
71031761|NCT00909610|141572193|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Geometric Mean|106.0||||||90.0|101.0|112.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||112|101|
71031762|NCT00909610|141572194|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Geometric Mean|101.0||||||90.0|91.9|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111|91.9|
71031763|NCT00909610|141572195|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Geometric Mean|105.0||||||90.0|100.0|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111|100|
71031764|NCT00909610|141572196|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Mean|101.0||||||90.0|92.5|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111|92.5|
71031765|NCT00909610|141572197|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Mean|110.0||||||90.0|103.0|117.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||117|103|
71031766|NCT00909610|141572198|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Mean|101.0||||||90.0|92.2|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111|92.2|
71031767|NCT00909610|141572199|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Mean|107.0||||||90.0|100.0|115.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||115|100|
71031768|NCT03585790|141572200|NON_INFERIORITY|Margin acceptable mean difference (Single Vision - Multifocal) = -5 rating units (0-100 scale, 0 = optimal)||||||0.18|||||||t-test, 1 sided|||Ho: Single Vision - Multifocal \>= M vs. Ho: Single Vision - Multifocal \< M. Alpha = 0.05, two sided beta = 0.80||||0.18
71031769|NCT05327491|141572204|EQUIVALENCE|It was concluded that the test treatment is bioequivalent to the reference treatment if the 90% CI for the ratio of Geometric Least Squares Mean (GLSM) was completely contained within the predefined interval of (0.8000, 1.2500).|Ratio of GLSM|0.962|||||TWO_SIDED|90.0|0.88|1.053||||||||1.053|0.880|
71031770|NCT05327491|141572205|EQUIVALENCE|It was concluded that the test treatment is bioequivalent to the reference treatment if the 90% CI for the ratio of Geometric Least Squares Mean (GLSM) was completely contained within the predefined interval of (0.8000, 1.2500).|Ratio of GLSM|0.968|||||TWO_SIDED|90.0|0.907|1.033||||||||1.033|0.907|
71031771|NCT05327491|141572206|EQUIVALENCE|It was concluded that the test treatment is bioequivalent to the reference treatment if the 90% CI for the ratio of Geometric Least Squares Mean (GLSM) was completely contained within the predefined interval of (0.8000, 1.2500).|Ratio of GLSM|0.967|||||TWO_SIDED|90.0|0.908|1.029||||||||1.029|0.908|
71031772|NCT02163837|141572217|SUPERIORITY|the study was exploratory, the number of patients included was not calculated|||||<|0.05|||||||McNemar|||Mc Nemar symetry test for repeated measures and paired t-tests as appropriated||||<0.05
71031773|NCT00834743|141572254|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.49||||||90.0|90.65|109.18|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||109.18|90.65|
71031774|NCT00834743|141572255|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.0||||||90.0|91.44|107.19|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.19|91.44|
71031775|NCT00834743|141572256|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.05||||||90.0|90.57|108.32|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.32|90.57|
70910888|NCT00495469|141311343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0||||0.024|TWO_SIDED|95.0|1.2|13.27||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (\<7 mmol/L)||13.27|1.20|0.024
71031776|NCT02728102|141572286|SUPERIORITY||difference in the proportions|2.9||||0.3657|TWO_SIDED|80.0|-8.8|14.6||A one-sided significance level of 0.10 is used to assess whether the vaccine appears promising relative to control.|Z test|||The proportion of patients alive and in CR/sCR at 1 year post transplant will be described in the vaccine and no vaccine groups with 80% confidence intervals and compared between groups using a two-sample Z test comparing binomial proportions.||14.6|-8.8|0.3657
71031777|NCT02728102|141572286|EQUIVALENCE|The stratified odds ratio is estimated with 80% confidence intervals.|Odds Ratio (OR)|1.19||||0.7461|TWO_SIDED|80.0|0.7|2.03||P-value is provided by Breslow-Day Test for Homogeneity of the Odds Ratios.|Cochran-Mantel-Haenszel||The Cochran-Mantel-Haenszel Odds Ratio estimate is for the Stratification. Stratum 1 is sCR/CR at Randomization. Stratum 2 is VGPR/PR/Stable Response at Randomization.|A secondary analysis stratified on disease response prior to randomization between arms will be conducted using a Cochran-Mantel-Haenszel test, and a stratified odds ratio along with 80% confidence intervals will be estimated.||2.03|0.70|0.7461
71031778|NCT02728102|141572286|SUPERIORITY|The proportion of patients alive and in CR/sCR at 1 year post transplant will be compared in the vaccine arm to Lenalidomide/GM-CSF arm with 80% confidence intervals using a two-sample Z test comparing binomial proportions.|difference in the proportions|7.2||||0.2429|TWO_SIDED|80.0|-6.4|20.6|||Z test|||A secondary pairwise analysis of CR/sCR rates comparing the vaccine arm to Lenalidomide/GM-CSF arm at 1 year post transplant.||20.6|-6.4|0.2429
70910889|NCT00495469|141311343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.85||||0.012|TWO_SIDED|95.0|1.41|16.66||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (\<7 mmol/L)||16.66|1.41|0.012
70910890|NCT00495469|141311343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.27|TWO_SIDED|95.0|0.62|5.54||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (\<7.8 mmol/L)||5.54|0.62|0.270
71031779|NCT02728102|141572286|SUPERIORITY|The proportion of patients alive and in CR/sCR at 1 year post transplant will be compared in the vaccine arm to Lenalidomide alone arm with 80% confidence intervals using a two-sample Z test comparing binomial proportions.|difference in the proportions|-1.6||||0.4397|TWO_SIDED|80.0|-15.6|12.4|||Z test|||A secondary pairwise analysis of CR rates comparing the vaccine arm to Lenalidomide alone arm at 1 year post transplant.||12.4|-15.6|0.4397
71031780|NCT02728102|141572287|SUPERIORITY|||||||0.9376||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||The proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine and the combined non-vaccine arms at 6 months Post Transplant.||||0.9376
71031781|NCT02728102|141572287|SUPERIORITY|||||||0.4887||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide/GM-CSF arm at 6 months Post Transplant.||||0.4887
71031782|NCT02728102|141572287|SUPERIORITY|||||||0.5176||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide alone arm at 6 months Post Transplant.||||0.5176
71031783|NCT02728102|141572287|SUPERIORITY|||||||0.2461||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between lenalidomide/GM-CSF arm and lenalidomide alone arm at 6 months Post Transplant.||||0.2461
71031784|NCT02728102|141572287|SUPERIORITY|||||||0.253||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||The proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine and the combined non-vaccine arms at 1 year Post Transplant.||||0.2530
71092241|NCT01013753|141691023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.023||0.0005||95.0|0.036|0.128|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.128|0.036|0.0005
71092242|NCT01013753|141691023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.09|0.181|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.181|0.090|<0.0001
71092243|NCT01013753|141691023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.083|0.174|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.174|0.083|<0.0001
71092244|NCT01013753|141691023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.111|0.203|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.203|0.111|<0.0001
71092245|NCT01013753|141691023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.051|0.143|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.143|0.051|<0.0001
71092246|NCT01013753|141691024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.028||0.0952||95.0|-0.008|0.103|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.103|-0.008|0.0952
71092247|NCT01013753|141691024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.028||0.0003||95.0|0.048|0.158|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.158|0.048|0.0003
71092248|NCT01013753|141691024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.028||0.0016||95.0|0.034|0.145|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.145|0.034|0.0016
71092249|NCT01013753|141691024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.071|0.183|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.183|0.071|<0.0001
71092250|NCT01013753|141691024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.028||0.0096||95.0|0.018|0.129|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.129|0.018|0.0096
71092251|NCT01013753|141691025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|STANDARD_ERROR_OF_MEAN|0.026||0.147||95.0|-0.013|0.088|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.088|-0.013|0.1470
70850247|NCT02785770|141188258|SUPERIORITY_OR_OTHER||LS mean difference|-1.19||||0.0948|TWO_SIDED|90.0|-2.35|-0.02|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.02|-2.35|0.0948
71031785|NCT02728102|141572287|SUPERIORITY|||||||0.2213||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide/GM-CSF arm at 1 year Post Transplant.||||0.2213
71031786|NCT02728102|141572287|SUPERIORITY|||||||0.493||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide alone arm at 1 year Post Transplant.||||0.4930
71031787|NCT02728102|141572287|SUPERIORITY|||||||0.6591||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the lenalidomide/GM-CSF arm and lenalidomide alone arm at 1 year Post Transplant.||||0.6591
71031788|NCT02728102|141572287|SUPERIORITY|||||||0.679||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||The proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine and the combined non-vaccine arms at 2 years Post Transplant.||||0.6790
71031789|NCT02728102|141572287|SUPERIORITY|||||||0.3124||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide/GM-CSF arm at 2 years Post Transplant.||||0.3124
71092252|NCT01013753|141691025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.025||0.0003||95.0|0.042|0.141|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.141|0.042|0.0003
71092253|NCT01013753|141691025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001||95.0|0.06|0.16|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.160|0.060|<0.0001
71092254|NCT01013753|141691025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.078|0.179|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.179|0.078|<0.0001
71092255|NCT01013753|141691025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.051|STANDARD_ERROR_OF_MEAN|0.025||0.0448||95.0|0.001|0.101|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.101|0.001|0.0448
71092256|NCT01013753|141691026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.408|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001||95.0|0.277|0.539|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.539|0.277|<0.0001
71092257|NCT01013753|141691026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.566|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001||95.0|0.438|0.695|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.695|0.438|<0.0001
71092258|NCT01013753|141691026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.612|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001||95.0|0.482|0.743|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.743|0.482|<0.0001
71092259|NCT01013753|141691026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001||95.0|0.539|0.801|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.801|0.539|<0.0001
71092260|NCT01013753|141691026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.588|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001||95.0|0.457|0.718|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.718|0.457|<0.0001
71092261|NCT01013753|141691027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.337|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.213|0.461|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.461|0.213|<0.0001
71092262|NCT01013753|141691027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.485|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001||95.0|0.363|0.606|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.606|0.363|<0.0001
71092263|NCT01013753|141691027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.531|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.408|0.655|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.655|0.408|<0.0001
71092264|NCT01013753|141691027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.648|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.524|0.772|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.772|0.524|<0.0001
71092265|NCT01013753|141691027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.551|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.428|0.674|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.674|0.428|<0.0001
71092266|NCT01013753|141691028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.373|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.253|0.493|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.493|0.253|<0.0001
71092267|NCT01013753|141691028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.527|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|0.409|0.645|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.645|0.409|<0.0001
71092268|NCT01013753|141691028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.572|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.453|0.692|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.692|0.453|<0.0001
71092269|NCT01013753|141691028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.54|0.781|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.781|0.540|<0.0001
71092270|NCT01013753|141691028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.451|0.689|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.689|0.451|<0.0001
71092271|NCT01013753|141691029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.302|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.168|0.436|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.436|0.168|<0.0001
71092272|NCT01013753|141691029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.429|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001||95.0|0.297|0.561|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.561|0.297|<0.0001
71092273|NCT01013753|141691029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.466|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.333|0.599|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.599|0.333|<0.0001
71092274|NCT01013753|141691029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.534|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.4|0.669|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.669|0.400|<0.0001
70910891|NCT00495469|141311343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.18||||0.043|TWO_SIDED|95.0|1.04|9.72||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (\<7.8 mmol/L)||9.72|1.04|0.043
71092275|NCT01013753|141691029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.504|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.371|0.637|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.637|0.371|<0.0001
71092276|NCT01013753|141691030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.264|STANDARD_ERROR_OF_MEAN|0.07||0.0002||95.0|0.127|0.401|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.401|0.127|0.0002
71092277|NCT01013753|141691030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.468|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001||95.0|0.333|0.602|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.602|0.333|<0.0001
71092278|NCT01013753|141691030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.484|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001||95.0|0.348|0.62|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.620|0.348|<0.0001
71092279|NCT01013753|141691030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.624|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|0.487|0.761|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.761|0.487|<0.0001
71092280|NCT01013753|141691030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.447|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001||95.0|0.311|0.583|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.583|0.311|<0.0001
71092281|NCT01013753|141691031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.012|STANDARD_ERROR_OF_MEAN|3.671|<|0.0001||95.0|14.802|29.223|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||29.223|14.802|<0.0001
71092282|NCT01013753|141691031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.022|STANDARD_ERROR_OF_MEAN|3.61|<|0.0001||95.0|21.931|36.114|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||36.114|21.931|<0.0001
71092283|NCT01013753|141691031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.887|STANDARD_ERROR_OF_MEAN|3.631|<|0.0001||95.0|20.755|35.019|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||35.019|20.755|<0.0001
71092284|NCT01013753|141691031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.935|STANDARD_ERROR_OF_MEAN|3.668|<|0.0001||95.0|25.73|40.139|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||40.139|25.730|<0.0001
71092285|NCT01013753|141691031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.528|STANDARD_ERROR_OF_MEAN|3.644|<|0.0001||95.0|16.371|30.686|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||30.686|16.371|<0.0001
71092286|NCT01013753|141691032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.92|STANDARD_ERROR_OF_MEAN|3.64|<|0.0001||95.0|7.77|22.071|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||22.071|7.770|<0.0001
71092287|NCT01013753|141691032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.834|STANDARD_ERROR_OF_MEAN|3.58|<|0.0001||95.0|17.801|31.866|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||31.866|17.801|<0.0001
71092288|NCT01013753|141691032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.613|STANDARD_ERROR_OF_MEAN|3.601|<|0.0001||95.0|16.539|30.686|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||30.686|16.539|<0.0001
71092289|NCT01013753|141691032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.449|STANDARD_ERROR_OF_MEAN|3.637|<|0.0001||95.0|21.305|35.594|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||35.594|21.305|<0.0001
71092290|NCT01013753|141691032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.439|STANDARD_ERROR_OF_MEAN|3.614|<|0.0001||95.0|13.341|27.538|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||27.538|13.341|<0.0001
71092291|NCT01013753|141691033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.994|STANDARD_ERROR_OF_MEAN|0.507|<|0.0001||95.0|-2.989|-0.999|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||-0.999|-2.989|<0.0001
71092292|NCT01013753|141691033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.095|STANDARD_ERROR_OF_MEAN|0.498|<|0.0001||95.0|-3.073|-1.116|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||-1.116|-3.073|<0.0001
71153653|NCT03530124|141799880|SUPERIORITY||Odds Ratio (OR)|1.93||||1|TWO_SIDED|95.0|0.17|21.63|||Mantel Haenszel||No adjustments were made to the alpha level (two-sided alpha=0.05) for the secondary objectives.|The proportion of infants requiring positive pressure ventilation for each group were compared using a Mantel-Haenszel statistic in a stratified analysis by study site and gestational age group to control for the randomization blocks at the two-sided alpha 0.05 level and corresponding 95% confidence interval for the occurrence of apnea during the 48-hour monitoring period.||21.63|0.17|1.0000
70910892|NCT00495469|141311343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.169|TWO_SIDED|95.0|0.72|6.53||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 500 mg QD: Responders (\<7.8 mmol/L)||6.53|0.72|0.169
70850248|NCT02785770|141188258|SUPERIORITY_OR_OTHER||LS mean difference|-0.74||||0.2959|TWO_SIDED|90.0|-1.91|0.43|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.43|-1.91|0.2959
70850249|NCT02785770|141188258|SUPERIORITY_OR_OTHER||LS mean difference|-0.07||||0.9161|TWO_SIDED|90.0|-1.24|1.09|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.09|-1.24|0.9161
70850250|NCT02785770|141188258|SUPERIORITY_OR_OTHER||LS mean difference|-2.07||||0.0036|TWO_SIDED|90.0|-3.24|-0.91|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.91|-3.24|0.0036
70850251|NCT02785770|141188258|SUPERIORITY_OR_OTHER||LS mean difference|-0.73||||0.3063|TWO_SIDED|90.0|-1.89|0.44|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.44|-1.89|0.3063
70850252|NCT02785770|141188258|SUPERIORITY_OR_OTHER||LS mean difference|-0.49||||0.4918|TWO_SIDED|90.0|-1.65|0.68|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.68|-1.65|0.4918
70850253|NCT02785770|141188258|SUPERIORITY_OR_OTHER||LS mean difference|-0.61||||0.3862|TWO_SIDED|90.0|-1.78|0.55|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.55|-1.78|0.3862
70850254|NCT00505778|141188270|NON_INFERIORITY_OR_EQUIVALENCE|To establish non-inferiority for primary efficacy variable at 2-sided upper confidence bound of 95% with 90% power, 442 patients per treatment group were required to be analyzable for primary efficacy analysis. Assuming 10% enrolled would not be analyzable, 1000 patients would be enrolled. If the 95% confidence interval's upper bound interval for the difference between the Asacol BID and Asacol QD group is \<10%, then non-inferiority of Asacol QD is claimed.|BID-QD Difference in Remission Rates|1.3||||0.5016|TWO_SIDED|95.0|-2.3|4.9|||Cochran-Mantel-Haenszel|Stratified by prior Asacol dose Category||Assumed true remission rate is 70% with no difference in remission rates between QD and BID dosing.The non-inferiority margin used in hypothesis testing was set to 10%.||4.9|-2.3|0.5016
70850255|NCT00505778|141188271|NON_INFERIORITY_OR_EQUIVALENCE|To establish non-inferiority for primary efficacy variable at 2-sided upper confidence bound of 95% with 90% power, 442 patients per treatment group were required to be analyzable for primary efficacy analysis. Assuming 10% enrolled would not be analyzable, 1000 patients would be enrolled. If the 95% confidence interval's upper bound interval for the difference between the Asacol BID and Asacol QD group is \<10%, then non-inferiority of Asacol QD is claimed.|BID-QD Difference in Remission Rates|0.8||||0.5426|TWO_SIDED|95.0|-1.8|3.5|||Cochran-Mantel-Haenszel|Stratified by prior Asacol dose Category||Assumed true remission rate is 70% with no difference in remission rates between QD and BID dosing.The non-inferiority margin used in hypothesis testing was set to 10%.||3.5|-1.8|0.5426
70850256|NCT00505778|141188272|NON_INFERIORITY_OR_EQUIVALENCE|To establish non-inferiority for primary efficacy variable at 2-sided upper confidence bound of 95% with 90% power, 442 patients per treatment group were required to be analyzable for primary efficacy analysis. Assuming 10% enrolled would not be analyzable, 1000 patients would be enrolled. If the 95% confidence interval's upper bound interval for the difference between the Asacol BID and Asacol QD group is \<10%, then non-inferiority of Asacol QD is claimed.|BID-QD Difference in Remission Rates|0.0||||0.977|TWO_SIDED|95.0|-4.6|4.7|||Cochran-Mantel-Haenszel|Stratified by prior Asacol dose Category||Assumed true remission rate is 70% with no difference in remission rates between QD and BID dosing.The non-inferiority margin used in hypothesis testing was set to 10%.||4.7|-4.6|0.9770
70850257|NCT00505778|141188273|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.4726|TWO_SIDED|95.0|0.762|1.796|||Log Rank|Stratified by prior Asacol dose Category||||1.796|0.762|0.4726
70850258|NCT00505778|141188274|SUPERIORITY_OR_OTHER||Difference BID-QD in Least Square Mean|-0.45||||0.1753|TWO_SIDED|95.0|-1.09|0.2|||ANOVA|ANOVA with prior Asacol dose category as factor.||||0.20|-1.09|0.1753
70850259|NCT00505778|141188275|NON_INFERIORITY_OR_EQUIVALENCE|To establish non-inferiority for primary efficacy variable at 2-sided upper confidence bound of 95% with 90% power, 442 patients per treatment group were required to be analyzable for primary efficacy analysis. Assuming 10% enrolled would not be analyzable, 1000 patients would be enrolled. If the 95% confidence interval's upper bound interval for the difference between the Asacol BID and Asacol QD group is \<10%, then non-inferiority of Asacol QD is claimed.|Difference BID-QD Remission Rates|3.6||||0.1557|TWO_SIDED|95.0|-1.3|8.5|||Cochran-Mantel-Haenszel|Stratified by prior Asacol dose Category||Assumed true remission rate is 70% with no difference in remission rates between QD and BID dosing.The non-inferiority margin used in hypothesis testing was set to 10%.||8.5|-1.3|0.1557
70850260|NCT02136069|141188279|SUPERIORITY||Adjusted Difference in Remission Rates|-0.9||||0.8114||95.0|-8.7|6.83|||Cochran-Mantel-Haenszel|||||6.83|-8.70|0.8114
70850261|NCT02136069|141188280|NON_INFERIORITY|with margin -12.5%|Adjusted Difference in Remission Rates|-12.0||||0.1293|TWO_SIDED|95.0|-20.5|-3.26||p-values are not multiplicity adjusted|Cochran-Mantel-Haenszel|A Farrington-Manning non-inferiority test was used to determine the nominal p-value.||||-3.26|-20.50|0.1293
70850262|NCT02136069|141188281|SUPERIORITY||Adjusted Difference in Remission Rates|-3.4||||0.4056|TWO_SIDED|95.0|-11.53|4.74||p-values are not multiplicity adjusted|Cochran-Mantel-Haenszel|||||4.74|-11.53|0.4056
70850263|NCT02136069|141188282|SUPERIORITY||Adjusted Difference in Remission Rates|-2.4||||0.4591|TWO_SIDED|95.0|-8.88|4.14||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||4.14|-8.88|0.4591
70850264|NCT02136069|141188283|SUPERIORITY||Adjusted Difference in Remission Rates|5.3||||0.4196|TWO_SIDED|95.0|-7.54|18.13||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||18.13|-7.54|0.4196
70850265|NCT02136069|141188284|SUPERIORITY||Adjusted Difference in Response Rates|-12.4||||0.0118|TWO_SIDED|95.0|-21.84|-2.66||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||-2.66|-21.84|0.0118
70850266|NCT02136069|141188285|SUPERIORITY||Adjusted Difference in Response Rates|-4.9||||0.2845|TWO_SIDED|95.0|-13.76|4.12||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||4.12|-13.76|0.2845
70850267|NCT02136069|141188286|SUPERIORITY||Adjusted Difference in Response Rates|-6.3||||0.1234|TWO_SIDED|95.0|-14.3|1.84||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||1.84|-14.30|0.1234
70850268|NCT02136069|141188287|SUPERIORITY||Adjusted Difference in Remission Rates|-5.0||||0.2168|TWO_SIDED|95.0|-12.84|2.94||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||2.94|-12.84|0.2168
70850269|NCT02136069|141188288|SUPERIORITY||Adjusted Difference in Response Rates|-9.5||||0.0564|TWO_SIDED|95.0|-19.06|0.29||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||0.29|-19.06|0.0564
70850270|NCT02136069|141188289|SUPERIORITY||Adjusted Difference in Response Rates|-6.0||||0.1729|TWO_SIDED|95.0|-14.51|2.7||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||2.70|-14.51|0.1729
70850271|NCT02136069|141188290|SUPERIORITY||Adjusted Difference in Remission Rates|-0.8||||0.8941|TWO_SIDED|95.0|-12.01|10.68||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||10.68|-12.01|0.8941
70850272|NCT02136069|141188299|SUPERIORITY|Week 10|Difference in Adjusted Means|-3.1||||0.4106|TWO_SIDED|95.0|-10.6|4.3||p-value has not been adjusted for multiplicity|ANCOVA|||||4.3|-10.6|0.4106
70850273|NCT02136069|141188299|SUPERIORITY|Week 30|Difference in Adjusted Means|-5.7||||0.1434|TWO_SIDED|95.0|-13.3|1.9||p-value has not been adjusted for multiplicity|ANCOVA|||||1.9|-13.3|0.1434
70850274|NCT02136069|141188299|SUPERIORITY|Week 54|Difference in Adjusted Means|-6.1||||0.1103|TWO_SIDED|95.0|-13.6|1.4||p-value has not been adjusted for multiplicity|ANCOVA|||||1.4|-13.6|0.1103
70850275|NCT01667419|141188303|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.001|TWO_SIDED|95.0|0.37|0.78|||Log Rank|||||0.78|0.37|0.0010
70850276|NCT01667419|141188303|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.2598|TWO_SIDED|95.0|0.54|1.18|||Log Rank|||||1.18|0.54|0.2598
70850277|NCT01667419|141188304|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.0133|TWO_SIDED|95.0|0.37|0.9|||Log Rank|||||0.90|0.37|0.0133
70850278|NCT01667419|141188304|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.6815|TWO_SIDED|95.0|0.57|1.44|||Log Rank|||||1.44|0.57|0.6815
70850279|NCT01667419|141188305|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0274|TWO_SIDED|95.0|0.3|0.94|||Log Rank|||||.94|0.30|0.0274
70850280|NCT01667419|141188305|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.8597|TWO_SIDED|95.0|0.55|1.66|||Log Rank|||||1.66|0.55|0.8597
70850281|NCT03364270|141188309|OTHER||Mean Difference (Final Values)|0.58||||0.001|TWO_SIDED|95.0|0.33|0.84||Threshold p\<0.05|t-test, 2 sided|||Null hypothesis: There is no difference in mean 18F-RGD uptake (expressed as a target to background ratio) in the culprit artery (carotid artery implicated in stroke or transient ischemic attack \[TIA\]) when compared to mean 18F-RGD uptake in the contralateral carotid artery. A paired t-test was used to compare 18F-RGD uptake in culprit plaque to plaque in the contralateral artery.||0.84|0.33|.001
70850282|NCT04380519|141188323|SUPERIORITY||Risk Ratio (RR)|1.012||||0.434|ONE_SIDED|97.5|0.88|||Hochberg adjustment was applied for p-values|Maximal Likelihood Estimator (MLE) model||||||0.880|0.434
70850283|NCT04380519|141188323|SUPERIORITY||Risk Ratio (RR)|1.125||||0.073|ONE_SIDED|97.5|0.989|||Hochberg adjustment was applied for p-values|Maximal Likelihood Estimator (MLE) model||||||0.989|0.073
70850284|NCT04380519|141188325|SUPERIORITY||Risk Ratio (RR)|1.019||||0.393|ONE_SIDED|97.5|0.892|||unadjusted|Maximal Likelihood Estimator (MLE) model||||||0.892|0.393
70850285|NCT04380519|141188325|SUPERIORITY||Risk Ratio (RR)|1.098||||0.061|ONE_SIDED|97.5|0.975|||unadjusted|Maximal Likelihood Estimator (MLE) model||||||0.975|0.061
70850286|NCT04380519|141188326|SUPERIORITY||Risk Ratio (RR)|0.67|||||TWO_SIDED|95.0|0.31|1.44||||||||1.44|0.31|
70850287|NCT04380519|141188326|SUPERIORITY||Risk Ratio (RR)|0.33|||||TWO_SIDED|95.0|0.12|0.89||||||||0.89|0.12|
70850288|NCT04380519|141188326|SUPERIORITY||Odds Ratio (OR)|0.64|||||TWO_SIDED|95.0|0.28|1.49||||||||1.49|0.28|
70850289|NCT04380519|141188326|SUPERIORITY||Odds Ratio (OR)|0.31|||||TWO_SIDED|95.0|0.11|0.87||||||||0.87|0.11|
70850290|NCT04380519|141188327|SUPERIORITY||Risk Ratio (RR)|2.35|||||TWO_SIDED|95.0|0.93|5.92||||||||5.92|0.93|
70850291|NCT04380519|141188327|SUPERIORITY||Risk Ratio (RR)|1.5|||||TWO_SIDED|95.0|0.55|4.09||||||||4.09|0.55|
70850292|NCT04380519|141188327|SUPERIORITY||Odds Ratio (OR)|2.53|||||TWO_SIDED|95.0|0.94|6.81||||||||6.81|0.94|
70850293|NCT04380519|141188327|SUPERIORITY||Odds Ratio (OR)|1.54|||||TWO_SIDED|95.0|0.53|4.46||||||||4.46|0.53|
70850294|NCT04173494|141188328|SUPERIORITY||Stratified Cochran-Mantel-Haenszel|15.67||||0.0095|TWO_SIDED|95.0|5.54|25.81|||Cochran-Mantel-Haenszel|||||25.81|5.54|0.0095
70850295|NCT04173494|141188329|NON_INFERIORITY|If the lower bound of the confidence interval (CI) is greater than 0, MMB was to be declared non-inferior to DAN.|Non-inferiority difference|13.58||||0.0116|TWO_SIDED|95.0|1.86|25.3|||Cochran-Mantel-Haenszel||Non-inferiority difference, defined as p(MMB) - (0.8) \*p(DAN) where p(MMB) is percentage of participants with TI status in MMB arm and p(DAN) is percentage of participants with TI status in DAN arm.|||25.30|1.86|0.0116
70850296|NCT04173494|141188330|OTHER||Stratified Cochran-Mantel-Haenszel|33.05|||<|0.0001|TWO_SIDED|95.0|22.59|43.51|||Cochran-Mantel-Haenszel|||||43.51|22.59|< 0.0001
70850297|NCT04173494|141188331|OTHER||Least Squares Mean Difference|-6.22||||0.0014|TWO_SIDED|95.0|-10.0|-2.43|||mixed model for repeated measures (MMRM)|||||-2.43|-10.0|0.0014
70850298|NCT04173494|141188332|OTHER||Stratified Cochran-Mantel-Haenszel|18.18||||0.0011|TWO_SIDED|95.0|9.77|26.59|||Cochran-Mantel-Haenszel|||||26.59|9.77|0.0011
70850299|NCT04173494|141188333|OTHER||Stratified Cochran-Mantel-Haenszel|17.2||||0.0012|TWO_SIDED|95.0|7.99|26.4|||Cochran-Mantel-Haenszel|||||26.40|7.99|0.0012
70850300|NCT04173494|141188334|OTHER||Stratified Cochran-Mantel-Haenszel|10.62||||0.1133|TWO_SIDED|95.0|-2.4|23.64|||Cochran-Mantel-Haenszel|||||23.64|-2.40|0.1133
70850301|NCT04173494|141188337|OTHER||Hazard Ratio (HR)|0.556||||0.0006|TWO_SIDED|95.0|0.397|0.778|||Anderson & Gill proportional means model|||||0.778|0.397|0.0006
70850302|NCT04173494|141188338|OTHER||Stratified CMH|-8.26||||0.1602|TWO_SIDED|95.0|-20.18|3.66|||Cochran-Mantel-Haenszel|||||3.66|-20.18|0.1602
70850303|NCT04173494|141188339|OTHER||Stratified CMH|19.0||||0.0124|TWO_SIDED|95.0|4.68|33.32|||Cochran-Mantel-Haenszel||\>=1g/dL Increase in Hemoglobin response|||33.32|4.68|0.0124
70850304|NCT04173494|141188339|OTHER||Stratified CMH|15.68||||0.0282|TWO_SIDED|95.0|2.47|28.9|||Cochran-Mantel-Haenszel||\>=1.5g/dL Increase in Hemoglobin response|||28.90|2.47|0.0282
71031790|NCT02728102|141572287|SUPERIORITY|||||||0.7379||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide alone arm at 2 years Post Transplant.||||0.7379
71031791|NCT02728102|141572287|SUPERIORITY|||||||0.2379||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the lenalidomide/GM-CSF arm and lenalidomide alone arm at 2 years Post Transplant.||||0.2379
71031792|NCT02728102|141572287|SUPERIORITY|||||||0.5353||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||Proportion of participants achieving CR among the subset of participants who are not in CR at the time of randomization between the vaccine and the combined non-vaccine arms at 6 months Post Transplant.||||0.5353
71031793|NCT02728102|141572287|SUPERIORITY|||||||0.4417||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||Proportion of participants achieving CR among the subset of participants who are not in CR at the time of randomization between the vaccine and the combined non-vaccine arms at 12 months Post Transplant.||||0.4417
71031794|NCT02728102|141572287|SUPERIORITY|||||||0.945||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||Proportion of participants achieving CR among the subset of participants who are not in CR at the time of randomization between the vaccine and the combined non-vaccine arms at 24 months Post Transplant.||||0.9450
71092293|NCT01013753|141691033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.836|STANDARD_ERROR_OF_MEAN|0.503||0.0003||95.0|-2.824|-0.849|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||-0.849|-2.824|0.0003
71092294|NCT01013753|141691033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.789|STANDARD_ERROR_OF_MEAN|0.506||0.0004||95.0|-2.783|-0.795|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||-0.795|-2.783|0.0004
71092295|NCT01013753|141691033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.27|STANDARD_ERROR_OF_MEAN|0.503||0.0118||95.0|-2.258|-0.283|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||-0.283|-2.258|0.0118
71092296|NCT01013753|141691034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.025||0.0002||95.0|0.045|0.141|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.141|0.045|0.0002
71092297|NCT01013753|141691034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.081|0.176|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.176|0.081|<0.0001
71092298|NCT01013753|141691034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.087|0.183|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.183|0.087|<0.0001
71092299|NCT01013753|141691034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001||95.0|0.121|0.217|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.217|0.121|<0.0001
71092300|NCT01013753|141691034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.024||0.0001||95.0|0.045|0.141|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.141|0.045|0.0001
71092301|NCT01013753|141691035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.024||0.0362||95.0|0.003|0.097|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.097|0.003|0.0362
71092302|NCT01013753|141691035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.023||0.0006||95.0|0.035|0.127|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.127|0.035|0.0006
71092303|NCT01013753|141691035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.024||0.0002||95.0|0.042|0.135|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.135|0.042|0.0002
71092304|NCT01013753|141691035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.07|0.164|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.164|0.070|<0.0001
71092305|NCT01013753|141691035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.024||0.001||95.0|0.032|0.125|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.125|0.032|0.0010
71092306|NCT01013753|141691036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.526|STANDARD_ERROR_OF_MEAN|0.124|<|0.0001||95.0|-0.77|-0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||-0.282|-0.770|<0.0001
71092307|NCT01013753|141691036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.432|STANDARD_ERROR_OF_MEAN|0.122||0.0004||95.0|-0.671|-0.192|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||-0.192|-0.671|0.0004
71092308|NCT01013753|141691036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.478|STANDARD_ERROR_OF_MEAN|0.123||0.0001||95.0|-0.72|-0.237|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||-0.237|-0.720|0.0001
71092309|NCT01013753|141691036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.657|STANDARD_ERROR_OF_MEAN|0.124|<|0.0001||95.0|-0.901|-0.413|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||-0.413|-0.901|<0.0001
71092310|NCT01013753|141691036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.449|STANDARD_ERROR_OF_MEAN|0.123||0.0003||95.0|-0.691|-0.207|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||-0.207|-0.691|0.0003
71092311|NCT01013753|141691041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.289|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.178|0.4|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.400|0.178|<0.0001
71092312|NCT01013753|141691041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.056||0.0002||95.0|0.099|0.318|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.318|0.099|0.0002
71092313|NCT01013753|141691041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.262|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.151|0.374|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.374|0.151|<0.0001
71092314|NCT01013753|141691041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.317|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.205|0.429|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.429|0.205|<0.0001
71092315|NCT01013753|141691041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.315|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.203|0.426|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.426|0.203|<0.0001
71092316|NCT01013753|141691042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.321|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|-0.432|-0.21|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||-0.210|-0.432|<0.0001
71092317|NCT01013753|141691042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.293|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|-0.403|-0.184|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||-0.184|-0.403|<0.0001
71092318|NCT01013753|141691042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.326|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|-0.436|-0.215|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||-0.215|-0.436|<0.0001
71092319|NCT01013753|141691042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.394|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|-0.505|-0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||-0.282|-0.505|<0.0001
71092320|NCT01013753|141691042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.346|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|-0.457|-0.235|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||-0.235|-0.457|<0.0001
71092321|NCT01013753|141691043|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.996||||0.6187||95.0|0.981|1.011|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||1.011|0.981|0.6187
71092322|NCT01013753|141691043|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.996||||0.6022||95.0|0.981|1.011|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||1.011|0.981|0.6022
71092323|NCT01013753|141691043|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.999||||0.8641||95.0|0.984|1.014|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||1.014|0.984|0.8641
71092324|NCT01013753|141691043|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.998||||0.7664||95.0|0.983|1.013|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||1.013|0.983|0.7664
71092325|NCT01013753|141691043|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.003||||0.6757||95.0|0.988|1.018|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||1.018|0.988|0.6757
71092326|NCT01013753|141691044|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.993||||0.4423||95.0|0.975|1.011|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||1.011|0.975|0.4423
71092327|NCT01013753|141691044|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.979||||0.0218||95.0|0.962|0.997|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.997|0.962|0.0218
71092328|NCT01013753|141691044|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.977||||0.0109||95.0|0.96|0.995|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.995|0.960|0.0109
70970596|NCT00531752|141447058|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09953|STANDARD_ERROR_OF_MEAN|0.3001||0.7415|TWO_SIDED|80.0|-0.4892|0.29012|||Mixed Models Analysis|||Week 3 (CQoL): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.29012|-0.4892|0.7415
71092329|NCT01013753|141691044|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.98||||0.0283||95.0|0.962|0.998|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.998|0.962|0.0283
71092330|NCT01013753|141691044|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.991||||0.3085||95.0|0.973|1.009|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||1.009|0.973|0.3085
70850305|NCT04173494|141188339|OTHER||Stratified CMH|6.97||||0.2844|TWO_SIDED|95.0|-5.41|19.35|||Cochran-Mantel-Haenszel||\>=2g/dL Increase in Hemoglobin response|||19.35|-5.41|0.2844
70850306|NCT04173494|141188344|OTHER||Hazard Ratio (HR)|0.89||||0.6879|TWO_SIDED|95.0|0.504|1.572|||Log Rank|||||1.572|0.504|0.6879
70850307|NCT04173494|141188345|OTHER||Hazard Ratio (HR)|0.804||||0.432|TWO_SIDED|95.0|0.466|1.386|||Log Rank|||||1.386|0.466|0.4320
70850308|NCT04173494|141188346|OTHER||Least Squares Mean Difference|-0.71||||0.0513|TWO_SIDED|95.0|-1.42|0.0|||MMRM|||||0.00|-1.42|0.0513
70850309|NCT04173494|141188347|OTHER||Least Squares Mean Difference|-10.82||||0.0113|TWO_SIDED|95.0|-19.15|-2.48|||MMRM|||||-2.48|-19.15|0.0113
70850310|NCT04173494|141188348|OTHER||Least Squares Mean Difference|1.31||||0.357|TWO_SIDED|95.0|-1.49|4.11|||MMRM|||||4.11|-1.49|0.3570
70850311|NCT02474069|141188349|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.087|TWO_SIDED|95.0|0.39|1.07|||ANCOVA|||Logistic regression model: Logit (proportion) = treatment + PASI Score at baseline + PASI score at randomization + error||1.07|0.39|0.087
70850312|NCT02474069|141188350|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.281|TWO_SIDED|95.0|0.43|1.28|||ANCOVA|||Logistic regression model: Logit (proportion) = treatment + PASI Score at baseline + PASI score at randomization + error||1.28|0.43|0.281
70850313|NCT03656380|141188361|SUPERIORITY|||||||0.14|||||||ANCOVA|||||||0.14
70850314|NCT03656380|141188362|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
70850315|NCT03656380|141188363|SUPERIORITY|||||||0.2|||||||Chi-squared|||||||0.20
70850316|NCT03656380|141188364|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70850317|NCT03656380|141188365|SUPERIORITY||||||<|0.001|||||||Chi-squared|||\<15 eos/hpf||||<0.001
70850318|NCT03656380|141188365|SUPERIORITY|||||||0.02|||||||Chi-squared|||≤6 eos/hpf||||0.02
70850319|NCT03656380|141188365|SUPERIORITY|||||||0.27|||||||Chi-squared|||≤1 eos/hpf||||0.27
70850320|NCT03656380|141188366|SUPERIORITY|||||||0.03|||||||ANCOVA|||||||0.03
70850321|NCT03656380|141188367|SUPERIORITY|||||||0.44|||||||ANCOVA|||||||0.44
70850322|NCT01388335|141188383|SUPERIORITY_OR_OTHER_LEGACY||Ratio|0.81|||||TWO_SIDED|90.0|0.691|0.95|||||Ratio of Geometric LS mean is for S-warfarin.|||0.950|0.691|
70850323|NCT01388335|141188383|SUPERIORITY_OR_OTHER_LEGACY||Ratio|0.912|||||TWO_SIDED|90.0|0.815|1.02|||||Ratio of Geometric LS mean is for R-warfarin.|||1.02|0.815|
70850324|NCT01388335|141188384|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.98|||||TWO_SIDED|90.0|0.76|3.5|||||Median Difference (Final Values) is for S-warfarin.|||3.50|0.76|
70850325|NCT01388335|141188384|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|2.5|||||TWO_SIDED|90.0|-1.0|6.84|||||Median Difference (Final Values) is for R-warfarin.|||6.84|-1.00|
70850326|NCT01388335|141188385|SUPERIORITY_OR_OTHER_LEGACY||Ratio|1.28|||||TWO_SIDED|90.0|1.14|1.44|||||Ratio of Geometric LS mean is for S-warfarin.|||1.44|1.14|
70850327|NCT01388335|141188385|SUPERIORITY_OR_OTHER_LEGACY||Ratio|1.26|||||TWO_SIDED|90.0|1.08|1.47|||||Ratio of Geometric LS mean is for R-warfarin.|||1.47|1.08|
70850328|NCT01388335|141188390|SUPERIORITY_OR_OTHER_LEGACY||Ratio|0.92|||||TWO_SIDED|90.0|0.86|1.0|||||Ratio of Geometric LS mean.|||1.00|0.86|
70850329|NCT01388335|141188391|SUPERIORITY_OR_OTHER_LEGACY||Ratio|0.98|||||TWO_SIDED|90.0|0.95|1.02|||||Ratio of Geometric LS mean.|||1.02|0.95|
70850330|NCT01388335|141188394|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Geometric LS Mean|1.03||||||90.0|0.99|1.08|||||Ratio of Geometric LS mean for Period 2, Day 14, 0 hours.|||1.08|0.99|
70850331|NCT01388335|141188394|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Geometric LS Means|1.02|||||TWO_SIDED|90.0|0.98|1.06|||||Ratio of Geometric LS mean for Period 2, Day 14, 4 hours.|||1.06|0.98|
70850332|NCT04413617|141188403|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.163||0.0158|TWO_SIDED|90.0|-0.62|-0.08|||Mixed Model Repeated Measures|||The primary clinical hypothesis is that mean decrease at Week 12 in DAS28-CRP score in one or both combo arms exceeds the mean decrease in the reference (tofacitinib) treatment arm, regardless of occurrence of intercurrent events. The null hypothesis is that the mean decrease in DAS28-CRP score at Week 12 is identical in the control (tofacitinib arm) and combination arms.||-0.08|-0.62|0.0158
70850333|NCT04413617|141188403|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.164||0.3933|TWO_SIDED|90.0|-0.32|0.23|||Mixed Model Repeated Measures|||The primary clinical hypothesis is that mean decrease at Week 12 in DAS28-CRP score in one or both combo arms exceeds the mean decrease in the reference (tofacitinib) treatment arm, regardless of occurrence of intercurrent events. The null hypothesis is that the mean decrease in DAS28-CRP score at Week 12 is identical in the control (tofacitinib arm) and combination arms.||0.23|-0.32|0.3933
70850334|NCT02657408|141188413|EQUIVALENCE|confirmatory statistical hypothesis tested|Geometric mean ratio (%)|1.27||||0.3043|TWO_SIDED|90.0|0.86|1.87|||ANOVA|||The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.87|0.86|0.3043
70850335|NCT02657408|141188414|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|1.01|||||TWO_SIDED|90.0|0.88|1.16||||||The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.16|0.88|
70850336|NCT02657408|141188415|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|1.54|||||TWO_SIDED|90.0|0.59|4.03||||||The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||4.03|0.59|
70850337|NCT02657408|141188416|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|1.17|||||TWO_SIDED|90.0|0.49|2.85||||||The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||2.85|0.49|
71092331|NCT01013753|141691045|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.999||||0.9112||95.0|0.984|1.015|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||1.015|0.984|0.9112
71092332|NCT01013753|141691045|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.992||||0.2955||95.0|0.977|1.007|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||1.007|0.977|0.2955
70850338|NCT02657408|141188417|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|1.29|||||TWO_SIDED|90.0|0.91|1.83||||||The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.83|0.91|
71092333|NCT01013753|141691045|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.987||||0.1029||95.0|0.973|1.003|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||1.003|0.973|0.1029
71092334|NCT01013753|141691045|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.991||||0.2552||95.0|0.975|1.007|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||1.007|0.975|0.2552
71092335|NCT01013753|141691045|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.994||||0.4803||95.0|0.979|1.01|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||1.010|0.979|0.4803
71092336|NCT04757636|141691047|SUPERIORITY||Least Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|1.03||0.861409|TWO_SIDED|95.0|-2.2|1.84|||MMRM|||||1.84|-2.20|0.861409
71092337|NCT04757636|141691047|SUPERIORITY||Least Squares Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|1.029||0.416264|TWO_SIDED|95.0|-2.86|1.18|||MMRM|||||1.18|-2.86|0.416264
71092338|NCT04757636|141691048|SUPERIORITY||Risk Difference (RD)|0.1||||0.981348|TWO_SIDED|95.0|-7.5|7.7|||Mantel Haenszel||The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.|||7.7|-7.5|0.981348
71092339|NCT04757636|141691048|SUPERIORITY||Risk Difference (RD)|-0.7||||0.856|TWO_SIDED|95.0|-8.5|7.0|||Mantel Haenszel||The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.|||7.0|-8.5|0.856000
71092340|NCT04757636|141691049|SUPERIORITY||Risk Difference (RD)|-1.7||||0.655104|TWO_SIDED|95.0|-8.9|5.6|||Mantel Haenszel||The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.|||5.6|-8.9|0.655104
71092341|NCT04757636|141691049|SUPERIORITY||Risk Difference (RD)|-0.8||||0.821257|TWO_SIDED|95.0|-8.2|6.5|||Mantel Haenszel||The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.|||6.5|-8.2|0.821257
71092342|NCT04757636|141691050|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.234||0.199828|TWO_SIDED|95.0|-0.76|0.16|||MMRM|||||0.16|-0.76|0.199828
71092343|NCT04757636|141691050|SUPERIORITY||Least Squares Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.235||0.188725|TWO_SIDED|95.0|-0.77|0.15|||MMRM|||||0.15|-0.77|0.188725
71092344|NCT04757636|141691051|SUPERIORITY||Risk Difference (RD)|-0.5||||0.84781|TWO_SIDED|95.0|-5.6|4.6|||Mantel Haenszel||The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.|||4.6|-5.6|0.847810
71092345|NCT04757636|141691051|SUPERIORITY||Risk Difference (RD)|0.9||||0.718699|TWO_SIDED|95.0|-4.2|6.1|||Mantel Haenszel||The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.|||6.1|-4.2|0.718699
71092346|NCT01433913|141691063|OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||||||0.23
71092347|NCT01433913|141691064|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71092348|NCT01433913|141691065|OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
71092349|NCT01433913|141691066|OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||||||0.09
71092350|NCT01433913|141691067|OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
71092351|NCT01433913|141691071|OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
71092352|NCT01433913|141691072|OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
71092353|NCT01433913|141691073|OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
71092354|NCT01433913|141691074|OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
71092355|NCT01433913|141691075|OTHER|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
71092356|NCT03813654|141691099|OTHER|Mixed model analysis with post-hoc tests.|Mean Difference (Final Values)|90.0|STANDARD_DEVIATION|68.7|<|0.05|TWO_SIDED|||||A priori threshold was \<0.05.|Mixed Models Analysis||This is the difference between the control and 8-h Free Sleep Group.|||||<0.05
71092357|NCT03813654|141691104|SUPERIORITY|||||||0.09||||||The groups had unequal variances, so we adjusted for unequal variances when doing the t-test. The a priori threshold for statistical significance was p\<0.05.|t-test, 1 sided|Adjusted for unequal variances between the two groups.||We compared the PVT taken at the start of the final night shift between Group B and those in Group C who slept in the morning and had complete data. Our hypothesis was that Group B would have faster RTs.||||0.09
71092358|NCT01208051|141691115|SUPERIORITY|||||||0.26||||||p-value is stratified by randomization factors.|Log Rank|The conditional power was 7.8%, reaching the futility boundary of \<15%. Patients on the combination arm were then crossed over to cediranib alone.||||||0.26
71092359|NCT01208051|141691116|SUPERIORITY|||||||0.36|||||||Log Rank|||||||0.36
71092360|NCT01208051|141691118|SUPERIORITY|||||||0.8|||||||Log Rank|||||||0.80
71092361|NCT01208051|141691119|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||||||0.83
70970597|NCT00531752|141447058|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04804|STANDARD_ERROR_OF_MEAN|0.3227||0.8822|TWO_SIDED|80.0|-0.3703|0.4664|||Mixed Models Analysis|||Week 3 (CQoL): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.46640|-0.3703|0.8822
71092362|NCT00973973|141691123|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.107||0.0262|TWO_SIDED|95.0|-0.45|-0.03|||ANCOVA|Analysis of covariance (ANCOVA) model including baseline value as a covariate.||Comparison of Change from Baseline at Week 4||-0.03|-0.45|0.0262
71092363|NCT00973973|141691123|SUPERIORITY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.152|<|0.0001|TWO_SIDED|95.0|-1.06|-0.46|||ANCOVA|Analysis of covariance (ANCOVA) model, including baseline value as a covariate.||Comparison of change from baseline at week 8||-0.46|-1.06|< 0.0001
71092364|NCT00973973|141691125|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.086||0.0163|TWO_SIDED|95.0|-0.38|-0.04|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 4||-0.04|-0.38|0.0163
71092365|NCT00973973|141691125|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.101||0.0066|TWO_SIDED|95.0|-0.48|-0.08|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8||-0.08|-0.48|0.0066
71092366|NCT00973973|141691127|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.082||0.0089|TWO_SIDED|95.0|-0.38|-0.06|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 4||-0.06|-0.38|0.0089
71092367|NCT00973973|141691127|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.1||0.0011|TWO_SIDED|95.0|-0.53|-0.14|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8||-0.14|-0.53|0.0011
71092368|NCT00973973|141691129|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.127||0.036|TWO_SIDED|95.0|-0.52|-0.02|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change form baseline at week 4||-0.02|-0.52|0.0360
71092369|NCT00973973|141691129|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.137||0.007|TWO_SIDED|95.0|-0.65|-0.11|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8||-0.11|-0.65|0.0070
71092370|NCT00973973|141691135|SUPERIORITY||LS Mean Difference|-9.84|STANDARD_ERROR_OF_MEAN|3.939||0.0137|TWO_SIDED|95.0|-17.63|-2.05|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 4||-2.05|-17.63|0.0137
71092371|NCT00973973|141691135|SUPERIORITY||LS Mean Difference|-12.44|STANDARD_ERROR_OF_MEAN|3.913||0.0019|TWO_SIDED|95.0|-20.19|-4.7|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8||-4.70|-20.19|0.0019
71092372|NCT00973973|141691137|SUPERIORITY||LS Mean Difference|-6.21|STANDARD_ERROR_OF_MEAN|2.728||0.0244|TWO_SIDED|95.0|-11.61|-0.81|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 4||-0.81|-11.61|0.0244
71092373|NCT00973973|141691137|SUPERIORITY||LS Mean Difference|-6.35|STANDARD_ERROR_OF_MEAN|2.549||0.0141|TWO_SIDED|95.0|-11.39|-1.3|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8||-1.30|-11.39|0.0141
71092374|NCT00973973|141691139|SUPERIORITY||LS Mean Difference|-3.12|STANDARD_ERROR_OF_MEAN|1.821||0.0893|TWO_SIDED|95.0|-6.72|0.49|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 4||0.49|-6.72|0.0893
71092375|NCT00973973|141691139|SUPERIORITY||LS Mean Difference|-3.52|STANDARD_ERROR_OF_MEAN|1.938||0.072|TWO_SIDED|95.0|-7.35|0.32|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8||0.32|-7.35|0.0720
71092376|NCT00973973|141691141|SUPERIORITY||LS Mean Difference|-2.26|STANDARD_ERROR_OF_MEAN|0.505|<|0.0001|TWO_SIDED|95.0|-3.26|-1.26|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of the change from baseline in CPSSS total score||-1.26|-3.26|< 0.0001
71092377|NCT00973973|141691141|SUPERIORITY||LS Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.41|-0.69|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline in CPSSS component of dysmenorrhea score||-0.69|-1.41|< 0.0001
71092378|NCT00973973|141691141|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.143||0.0139|TWO_SIDED|95.0|-0.64|-0.07|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline in CPSSS component of non-menstrual pelvic pain score||-0.07|-0.64|0.0139
71092379|NCT00973973|141691141|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.173||0.1052|TWO_SIDED|95.0|-0.63|0.06|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline in CPSSS component of dyspareunia score||0.06|-0.63|0.1052
71092380|NCT00973973|141691141|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.143||0.0081|TWO_SIDED|95.0|-0.67|-0.1|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline in CPSSS component of pelvic tenderness score||-0.10|-0.67|0.0081
71092381|NCT00973973|141691141|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.125||0.024|TWO_SIDED|95.0|-0.53|-0.04|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline in CPSSS component of induration score||-0.04|-0.53|0.0240
71092382|NCT00973973|141691143|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.23||0.0012|TWO_SIDED|95.0|-1.2|-0.3|||ANOVA|||Comparison of Patient Global Impression of Change at week 4||-0.3|-1.2|0.0012
71092383|NCT00973973|141691143|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.26||0.0002|TWO_SIDED|95.0|-1.5|-0.5|||ANOVA|||Comparison of Patient Global Impression of Change at week 8||-0.5|-1.5|0.0002
71092384|NCT00973973|141691145|SUPERIORITY||Difference|19.4||||0.0136|TWO_SIDED|95.0|4.4|34.4|||Pearson chi-squared|||Comparison of response rates at week 4||34.4|4.4|0.0136
71092385|NCT00973973|141691145|SUPERIORITY||Difference|30.2||||0.0007|TWO_SIDED|95.0|13.6|46.7|||Pearson chi-squared|||Comparison of response rates at week 8||46.7|13.6|0.0007
70910893|NCT00495469|141311343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.12||||0.042|TWO_SIDED|95.0|1.04|9.36||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (\<7.8 mmol/L)||9.36|1.04|0.042
70910894|NCT00495469|141311343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.69||||0.02|TWO_SIDED|95.0|1.23|11.06||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (\<7.8 mmol/L)||11.06|1.23|0.020
70910895|NCT00495469|141311343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04||||0.211|TWO_SIDED|95.0|0.67|6.24||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (\<7.8 mmol/L)||6.24|0.67|0.211
70910896|NCT00495469|141311343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9||||0.179|TWO_SIDED|95.0|0.61|13.75||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (reduction \>=1.7 mmol/L)||13.75|0.61|0.179
70910897|NCT00495469|141311343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.93||||0.03|TWO_SIDED|95.0|1.17|20.87||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (reduction \>=1.7 mmol/L)||20.87|1.17|0.030
70910898|NCT00495469|141311343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.99||||0.142|TWO_SIDED|95.0|0.69|12.86||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 500 mg QD: Responders (reduction \>=1.7 mmol/L)||12.86|0.69|0.142
70910899|NCT00495469|141311343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.21||||0.012|TWO_SIDED|95.0|1.49|25.83||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (reduction \>=1.7 mmol/L)||25.83|1.49|0.012
70910900|NCT00495469|141311343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.01|||<|0.001|TWO_SIDED|95.0|3.14|54.0||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (reduction \>=1.7 mmol/L)||54.00|3.14|<0.001
71092386|NCT02832037|141691173|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.||||||0.0145||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0145
71153654|NCT02504216|141799953|SUPERIORITY||Hazard Ratio (HR)|0.85|||=|0.0043|TWO_SIDED|95.0|0.76|0.96|||Log Rank|P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.||IxRS: Interactive web/voice response system||0.96|0.76|=0.0043
71153655|NCT02504216|141799954|OTHER||Hazard Ratio (HR)|1.43|||=|0.0695|TWO_SIDED|95.0|0.97|2.1|||Log Rank|P-value (2-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.||||2.10|0.97|=0.0695
70910901|NCT00495469|141311343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.6||||0.01|TWO_SIDED|95.0|1.56|27.99||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (reduction \>=1.7 mmol/L)||27.99|1.56|0.010
70910902|NCT00495469|141311344|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.318|TWO_SIDED|95.0|-0.19|0.59||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.59|-0.19|0.318
70910903|NCT00495469|141311344|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32||||0.131|TWO_SIDED|95.0|-0.73|0.1||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.10|-0.73|0.131
70910904|NCT00495469|141311344|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.452|TWO_SIDED|95.0|-0.54|0.24||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.24|-0.54|0.452
70910905|NCT00495469|141311344|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.845|TWO_SIDED|95.0|-0.44|0.36||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.36|-0.44|0.845
70910906|NCT00495469|141311344|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.393|TWO_SIDED|95.0|-0.58|0.23||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.23|-0.58|0.393
70910907|NCT00495469|141311344|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.072|TWO_SIDED|95.0|-0.76|0.03||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.03|-0.76|0.072
70910908|NCT00495469|141311345|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.767|TWO_SIDED|95.0|-0.4|0.3||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.30|-0.40|0.767
70910909|NCT00495469|141311345|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.604|TWO_SIDED|95.0|-0.46|0.27||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.27|-0.46|0.604
70910910|NCT00495469|141311345|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13||||0.483|TWO_SIDED|95.0|-0.23|0.48||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.48|-0.23|0.483
70910911|NCT00495469|141311345|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.956|TWO_SIDED|95.0|-0.35|0.37||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.37|-0.35|0.956
70910912|NCT00495469|141311345|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24||||0.185|TWO_SIDED|95.0|-0.12|0.6||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.60|-0.12|0.185
70910913|NCT00495469|141311345|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.863|TWO_SIDED|95.0|-0.32|0.39||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.39|-0.32|0.863
70910914|NCT00495469|141311346|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.348|TWO_SIDED|95.0|-0.46|0.16||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.16|-0.46|0.348
70910915|NCT00495469|141311346|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.952|TWO_SIDED|95.0|-0.33|0.31||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.31|-0.33|0.952
70910916|NCT00495469|141311346|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.523|TWO_SIDED|95.0|-0.21|0.42||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.42|-0.21|0.523
70910917|NCT00495469|141311346|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.889|TWO_SIDED|95.0|-0.34|0.29||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.29|-0.34|0.889
70910918|NCT00495469|141311346|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25||||0.124|TWO_SIDED|95.0|-0.07|0.56||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.56|-0.07|0.124
70910919|NCT00495469|141311346|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.581|TWO_SIDED|95.0|-0.22|0.4||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.40|-0.22|0.581
70910920|NCT00495469|141311347|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.518|TWO_SIDED|95.0|-0.05|0.1||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.10|-0.05|0.518
70910921|NCT00495469|141311347|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.352|TWO_SIDED|95.0|-0.04|0.11||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.11|-0.04|0.352
70910922|NCT00495469|141311347|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.026|TWO_SIDED|95.0|0.01|0.16||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.16|0.01|0.026
70910923|NCT00495469|141311347|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.069|TWO_SIDED|95.0|-0.01|0.14||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.14|-0.01|0.069
70910924|NCT00495469|141311347|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06||||0.154|TWO_SIDED|95.0|-0.02|0.13||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.13|-0.02|0.154
71092387|NCT02832037|141691173|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.||||||0.0148||||||Adjusted for multiplicity.|MCP-Mod linear in log model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0148
70910925|NCT00495469|141311347|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.005|TWO_SIDED|95.0|0.03|0.18||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.18|0.03|0.005
70910926|NCT00495469|141311348|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.143|TWO_SIDED|95.0|-0.58|0.08||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.08|-0.58|0.143
70910927|NCT00495469|141311348|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.495|TWO_SIDED|95.0|-0.46|0.22||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.22|-0.46|0.495
70910928|NCT00495469|141311348|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19||||0.261|TWO_SIDED|95.0|-0.52|0.14||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.14|-0.52|0.261
70910929|NCT00495469|141311348|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.446|TWO_SIDED|95.0|-0.46|0.2||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.20|-0.46|0.446
71153656|NCT02504216|141799955|SUPERIORITY||Hazard Ratio (HR)|0.8|||=|0.0004|TWO_SIDED|95.0|0.71|0.91||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||0.91|0.71|=0.0004
70910930|NCT00495469|141311348|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.783|TWO_SIDED|95.0|-0.29|0.38||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.38|-0.29|0.783
70910931|NCT00495469|141311348|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.454|TWO_SIDED|95.0|-0.46|0.21||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.21|-0.46|0.454
70910932|NCT00495469|141311349|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19||||0.363|TWO_SIDED|95.0|-0.59|0.22||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.22|-0.59|0.363
70910933|NCT00495469|141311349|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34||||0.111|TWO_SIDED|95.0|-0.76|0.08||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.08|-0.76|0.111
70910934|NCT00495469|141311349|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.08|TWO_SIDED|95.0|-0.77|0.04||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.04|-0.77|0.080
70910935|NCT00495469|141311349|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.23||||0.267|TWO_SIDED|95.0|-0.64|0.18||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.18|-0.64|0.267
70910936|NCT00495469|141311349|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.549|TWO_SIDED|95.0|-0.54|0.29||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.29|-0.54|0.549
70910937|NCT00495469|141311349|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.056|TWO_SIDED|95.0|-0.81|0.01||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.01|-0.81|0.056
70910938|NCT00495469|141311350|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.396|TWO_SIDED|95.0|-1.65|0.66||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.66|-1.65|0.396
70910939|NCT00495469|141311350|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.51||||0.013|TWO_SIDED|95.0|-2.7|-0.33||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||-0.33|-2.70|0.013
70910940|NCT00495469|141311350|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.44||||0.017|TWO_SIDED|95.0|-2.61|-0.26||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||-0.26|-2.61|0.017
70910941|NCT00495469|141311350|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.45||||0.015|TWO_SIDED|95.0|-2.61|-0.28||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||-0.28|-2.61|0.015
70910942|NCT00495469|141311350|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09||||0.069|TWO_SIDED|95.0|-2.26|0.08||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.08|-2.26|0.069
70910943|NCT00495469|141311350|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.03||||0.086|TWO_SIDED|95.0|-0.15|2.2||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||2.20|-0.15|0.086
70910944|NCT01323660|141311363|SUPERIORITY_OR_OTHER||Least squares mean difference|25.0||||0.456|TWO_SIDED|95.0|-41.0|91.0||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 62.5 µg minus Placebo.|||91.0|-41.0|0.456
70910945|NCT01323660|141311363|SUPERIORITY_OR_OTHER||Least squares mean difference|74.7||||0.033|TWO_SIDED|95.0|6.0|143.4||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 125 µg minus Placebo.|||143.4|6.0|0.033
70910946|NCT01323660|141311363|SUPERIORITY_OR_OTHER||Least squares mean difference|30.6||||0.295|TWO_SIDED|95.0|-26.8|88.0||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=VI 25 µg minus Placebo.|||88.0|-26.8|0.295
70910947|NCT01323660|141311363|SUPERIORITY_OR_OTHER||Least squares mean difference|44.4||||0.188|TWO_SIDED|95.0|-21.8|110.6||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus UMEC 62.5 µg.|||110.6|-21.8|0.188
70910948|NCT01323660|141311363|SUPERIORITY_OR_OTHER||Least squares mean difference|38.8||||0.187|TWO_SIDED|95.0|-18.9|96.5||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus VI 25 µg.|||96.5|-18.9|0.187
70910949|NCT01323660|141311363|SUPERIORITY_OR_OTHER||Least squares mean difference|-8.9||||0.801|TWO_SIDED|95.0|-77.8|60.1||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus UMEC 125 µg|||60.1|-77.8|0.801
70910950|NCT01323660|141311363|SUPERIORITY_OR_OTHER||Least squares mean difference|35.2||||0.233|TWO_SIDED|95.0|-22.7|93.1||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus VI 25 µg.|||93.1|-22.7|0.233
70910951|NCT01323660|141311363|SUPERIORITY_OR_OTHER||Least squares mean difference|69.4||||0.003|TWO_SIDED|95.0|24.5|114.4|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||114.4|24.5|0.003
70910952|NCT01323660|141311363|SUPERIORITY_OR_OTHER||Least squares mean difference|65.8||||0.005|TWO_SIDED|95.0|20.3|111.3|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus Placebo.|||111.3|20.3|0.005
70910953|NCT01323660|141311364|SUPERIORITY_OR_OTHER||Least squares mean difference|0.144|||<|0.001|TWO_SIDED|95.0|0.086|0.203|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 62.5 µg minus Placebo.|||0.203|0.086|<0.001
70910954|NCT01323660|141311364|SUPERIORITY_OR_OTHER||Least squares mean difference|0.255|||<|0.001|TWO_SIDED|95.0|0.193|0.318|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 125 µg minus Placebo.|||0.318|0.193|<0.001
70910955|NCT01323660|141311364|SUPERIORITY_OR_OTHER||Least squares mean difference|0.112|||<|0.001||95.0|0.061|0.163|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=VI 25 µg minus Placebo.|||0.163|0.061|<0.001
70910956|NCT01323660|141311364|SUPERIORITY_OR_OTHER||Least squares mean difference|0.099|||<|0.001|TWO_SIDED|95.0|0.041|0.157|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus UMEC 62.5 µg.|||0.157|0.041|<0.001
70910957|NCT01323660|141311364|SUPERIORITY_OR_OTHER||Least squares mean difference|0.132|||<|0.001|TWO_SIDED|95.0|0.081|0.183|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus VI 25 µg.|||0.183|0.081|<0.001
70910958|NCT01323660|141311364|SUPERIORITY_OR_OTHER||Least squares mean difference|0.006||||0.849|TWO_SIDED|95.0|-0.055|0.067|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus UMEC 125 µg.|||0.067|-0.055|0.849
70910959|NCT01323660|141311364|SUPERIORITY_OR_OTHER||Least squares mean difference|0.15|||<|0.001|TWO_SIDED|95.0|0.098|0.201|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus VI 25 µg.|||0.201|0.098|<0.001
70910960|NCT01323660|141311364|SUPERIORITY_OR_OTHER||Least squares mean difference|0.243|||<|0.001|TWO_SIDED|95.0|0.202|0.284|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||0.284|0.202|<0.001
70910961|NCT01323660|141311364|SUPERIORITY_OR_OTHER||Least squares mean difference|0.261|||<|0.001|TWO_SIDED|95.0|0.22|0.303|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus Placebo.|||0.303|0.220|<0.001
71153657|NCT02504216|141799956|SUPERIORITY||Hazard Ratio (HR)|0.88|||=|0.014|TWO_SIDED|95.0|0.79|0.99||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||0.99|0.79|=0.0140
70910962|NCT02584790|141311398|OTHER|||||||0.004|||||||Chi-squared|||2x2 table of: Row: 1. NBI suspicious pattern 2. NBI non-suspicious pattern Category: 1. with residual disease 2. without residual disease||||0.004
70910963|NCT00372567|141311417|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.484|2.235|||Cox Proportional Hazards Model|Model stratified by previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||No hypothesis tested.||2.235|0.484|
70910964|NCT00372567|141311418|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.818|||||TWO_SIDED|95.0|0.64|12.41|||Cox Proportional Hazards Model|Model stratified by previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||||12.41|0.640|
70910965|NCT00372567|141311420|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.027|||||TWO_SIDED|95.0|0.505|2.088|||Cox Proportional Hazards Model|Model stratified by previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||||2.088|0.505|
70910966|NCT00372567|141311421|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.308|||||TWO_SIDED|95.0|0.4|13.0|||Cochran-Mantel-Haenszel|Stratified by previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||||13.0|0.4|
70910967|NCT00372567|141311424|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.434|||||TWO_SIDED|95.0|1.057|11.15|||Cox Proportional Hazards Model|Model stratified by previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||||11.15|1.057|
70910968|NCT00372567|141311425|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.379|||||TWO_SIDED|95.0|0.1|2.3|||Cochran-Mantel-Haenszel|Stratified for previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||||2.3|0.1|
70910969|NCT00372567|141311426|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.318|||||TWO_SIDED|95.0|0.5|3.8|||Cochran-Mantel-Haenszel|Stratified for previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||||3.8|0.5|
70910970|NCT00958009|141311475|SUPERIORITY_OR_OTHER||mean positive response|0.86|||||TWO_SIDED|95.0|0.8|0.93|||||Confidence Interval calculated from normal approximation to the binomial. The primary objective was met if the lower bound of the 95% confidence interval is \>0.50.|||0.93|0.80|
70910971|NCT00755755|141311477|SUPERIORITY_OR_OTHER||Difference in proportions|72.7|||<|0.001|TWO_SIDED|95.0|55.1|83.2||As comparison involved two doses of PGL4001 vs Placebo, Bonferroni correction used with p-values doubled (threshold was 0.05) and confidence intervals adjusted|Cochran-Mantel-Haenszel|Adjustment for randomization strata|Confidence intervals with the use of Newcombe-Wilson score method (uncorrected)|||83.2|55.1|<0.001
70910972|NCT00755755|141311477|SUPERIORITY_OR_OTHER||Difference in proportions|73.7|||<|0.001|TWO_SIDED|95.0|56.2|84.0||As comparison involved two doses of PGL4001 vs Placebo, Bonferroni correction used with p values doubled (threshold was 0.05) and confidence intervals adjusted|Cochran-Mantel-Haenszel|Adjustment for randomization strata|Confidence intervals with the use of Newcombe-Wilson score method (uncorrected)|||84.0|56.2|<0.001
70910973|NCT00755755|141311478|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-22.6||||0.002|TWO_SIDED|95.0|-36.1|-8.2||As comparison involved two doses of PGL4001 vs Placebo, Bonferroni correction used with p-values doubled (threshold was 0.05) and confidence intervals adjusted.|Wilcoxon (Mann-Whitney)|Use of the Van Elteren extension to the Wilcoxon rank-sum test with adjustment for randomization strata|Hodges-Lehmann point estimator with corresponding Moses confidence interval.|||-8.2|-36.1|0.002
70910974|NCT00755755|141311478|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-18.2||||0.006|TWO_SIDED|95.0|-33.0|-5.2||As comparison involved two doses of PGL4001 vs Placebo, Bonferroni correction used with p values doubled (threshold was 0.05) and confidence intervals adjusted.|Wilcoxon (Mann-Whitney)|Use of the Van Elteren extension to the Wilcoxon rank-sum test with adjustment for randomization strata|Hodges-Lehmann point estimator with corresponding Moses confidence interval.|||-5.2|-33.0|0.006
70910975|NCT00558753|141311479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.003||95.0|||||t-test, 2 sided|||||||0.003
70910976|NCT00558753|141311480|SUPERIORITY_OR_OTHER||Independence: Chi-squared|10.3||||0.0013||95.0|||||Chi-squared|||For 3 month followup on incidence of neuropathic pain.||||0.0013
70910977|NCT00558753|141311480|SUPERIORITY_OR_OTHER||Independence: Chi-squared|6.05||||0.0139|||||||Chi-squared|||For 6 month followup on incidence of neuropathic pain.||||0.0139
70910978|NCT00558753|141311481|SUPERIORITY_OR_OTHER||Slope|-4.2||||0.0133||95.0||||Test of condition(Placebo v Pregabalin) main effect.|Mixed Models Analysis|Mixed model with main effects and time by condition interaction.||Mixed model test of condition (Placebo v Pregabalin) main effect.||||0.0133
70910979|NCT00558753|141311481|SUPERIORITY_OR_OTHER||Interaction Slice F-value|1.04||||0.3097||95.0|||||Mixed Models Analysis|Mixed model test of Condition Effect (Placebo v Pregabalin) at the 1-day post surgery time point (Slice)||Test of Condition Effect (Placebo v Pregabalin) at the 1-day post surgery time point (Slice)||||0.3097
70910980|NCT00558753|141311481|SUPERIORITY_OR_OTHER||Interaction Slice F-value|5.1||||0.0247||95.0|||||Mixed Models Analysis|||Test of Condition Effect (Placebo v Pregabalin) at the 2-day post surgery time point (Slice)||||0.0247
70910981|NCT00558753|141311481|SUPERIORITY_OR_OTHER||Interaction Slice F-value|3.11||||0.0786||95.0|||||Mixed Models Analysis|||Test of Condition Effect (Placebo v Pregabalin) at the 3-day post surgery time point (Slice)||||0.0786
70910982|NCT00558753|141311481|SUPERIORITY_OR_OTHER||Interaction Slice F-value|5.04||||0.0254||95.0|||||Mixed Models Analysis|||Test of Condition Effect (Placebo v Pregabalin) at the 30-day post surgery time point (Slice)||||0.0254
70910983|NCT04668144|141311482|NON_INFERIORITY|Under the assumption of 0 difference in mean PRU between groups and a common standard deviation of 50 PRU, a sample size of 22 patients per group would allow for the 95%CI to stay within ± 45 PRU with a 90% power and alpha=0.05. In line with previously reported investigations, 45 PRU was chosen for the noninferiority margin for the upper 95%CI limit of the difference.|Mean Difference (Final Values)|130.0|||||TWO_SIDED|95.0|85.0|176.0||p-value was not calculated for noninferiority analysis|ANCOVA|||The primary hypothesis of our study was that in patients receiving concomitant administration of cangrelor and prasugrel (experimental arm), platelet inhibition as assessed by PRU would be noninferior to patients receiving prasugrel only (active control)||176|85|
70910984|NCT01027871|141311492|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|0.17||||0.433|TWO_SIDED|90.0|-0.18|0.52||The statistical significance level is 0.10.|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.52|-0.18|0.433
70910985|NCT01027871|141311493|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.2||||0.388|TWO_SIDED|90.0|-0.59|0.19||The statistical significance level is 0.10.|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.19|-0.59|0.388
70910986|NCT01027871|141311494|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.09||||0.197|TWO_SIDED|90.0|-0.21|0.03||The statistical significance level is 0.10.|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.03|-0.21|0.197
70910987|NCT01027871|141311495|SUPERIORITY_OR_OTHER|||||||0.609||95.0||||"The statistical significance level is 0.10.~P-value is for HbA1c \<7.0%"|Fisher Exact|||||||0.609
70910988|NCT01027871|141311495|SUPERIORITY_OR_OTHER|||||||0.314||95.0||||"The statistical significance level is 0.10.~P-value is for HbA1c ≤6.5%"|Fisher Exact|||||||0.314
70910989|NCT01027871|141311496|SUPERIORITY_OR_OTHER|||||||0.375||95.0||||"The statistical significance level is 0.10.~P-value is for HbA1c \<7.0%."|Fisher Exact|||||||0.375
70910990|NCT01027871|141311496|SUPERIORITY_OR_OTHER|||||||0.811||95.0||||"The statistical significance level is 0.10.~P- value is for HbA1c ≤6.5%"|Fisher Exact|||||||0.811
70910991|NCT01027871|141311497|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.43||||0.144|TWO_SIDED|90.0|-0.92|0.05||"The statistical significance level is 0.10.~P- value is for morning 2-hr postprandial BG"|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.05|-0.92|0.144
70910992|NCT01027871|141311497|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.25||||0.36|TWO_SIDED|90.0|-0.7|0.2||"The statistical significance level is 0.10.~P-value is for midday pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.20|-0.70|0.360
70910993|NCT01027871|141311497|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.26||||0.342|TWO_SIDED|90.0|-0.72|0.19||"The statistical significance level is 0.10.~P-value is for midday 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.19|-0.72|0.342
70910994|NCT01027871|141311497|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.12||||0.654|TWO_SIDED|90.0|-0.56|0.32||"The statistical significance level is 0.10.~P-value is for evening pre-meal BG"|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.32|-0.56|0.654
70910995|NCT01027871|141311497|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.25||||0.387|TWO_SIDED|90.0|-0.73|0.23||"The statistical significance level is 0.10.~P-value is for evening 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.23|-0.73|0.387
70910996|NCT01027871|141311497|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.29||||0.339|TWO_SIDED|90.0|-0.79|0.21||"The statistical significance level is 0.10.~P-value is for bed time BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.21|-0.79|0.339
70910997|NCT01027871|141311497|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|0.1||||0.676|TWO_SIDED|90.0|-0.3|0.5||"The statistical significance level is 0.10.~P-value is for 0300 hours BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.50|-0.30|0.676
70910998|NCT01027871|141311499|SUPERIORITY_OR_OTHER|||||||0.162||95.0||||The statistical significance level is 0.10.|Fisher Exact|||||||0.162
70910999|NCT01027871|141311500|SUPERIORITY_OR_OTHER|||||||0.804||95.0||||The statistical significance level is 0.10.|Negative Binomial Model|||||||0.804
70911000|NCT01027871|141311502|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.01||||0.937||90.0|-0.16|0.14||"The statistical significance level is 0.10.~P-value is for baseline."|ANOVA||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.14|-0.16|0.937
70911001|NCT01027871|141311502|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.03||||0.687|TWO_SIDED|90.0|-0.16|0.1||"The statistical significance level is 0.10.~P-value is for Week 12."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.10|-0.16|0.687
70911002|NCT01027871|141311504|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.4||||0.159|TWO_SIDED|90.0|-0.87|0.07||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.07|-0.87|0.159
70911003|NCT01027871|141311504|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.17||||0.542|TWO_SIDED|90.0|-0.62|0.29||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.29|-0.62|0.542
70911004|NCT01027871|141311505|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.01||||0.88|TWO_SIDED|90.0|-0.16|0.13||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.13|-0.16|0.880
70911005|NCT01027871|141311505|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.17||||0.045|TWO_SIDED|90.0|-0.32|-0.03||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||-0.03|-0.32|0.045
70911006|NCT01027871|141311506|SUPERIORITY_OR_OTHER|||||||0.273||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c \<7.0%."|Fisher Exact|||||||0.273
70911007|NCT01027871|141311506|SUPERIORITY_OR_OTHER|||||||0.287||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c ≤6.5%."|Fisher Exact|||||||0.287
70911008|NCT01027871|141311506|SUPERIORITY_OR_OTHER|||||||0.879||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c \<7.0%."|Fisher Exact|||||||0.879
70911009|NCT01027871|141311506|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c ≤6.5%."|Fisher Exact|||||||0.722
70911010|NCT01027871|141311507|SUPERIORITY_OR_OTHER|||||||0.139||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c \<7.0%."|Fisher Exact|||||||0.139
70911011|NCT01027871|141311507|SUPERIORITY_OR_OTHER|||||||0.569||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c ≤6.5%."|Fisher Exact|||||||0.569
71153658|NCT02504216|141799957|SUPERIORITY||Hazard Ratio (HR)|0.72|||<|0.0001|TWO_SIDED|95.0|0.62|0.85||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||0.85|0.62|<0.0001
70911012|NCT01027871|141311507|SUPERIORITY_OR_OTHER|||||||0.515||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c \<7.0%."|Fisher Exact|||||||0.515
70911013|NCT01027871|141311507|SUPERIORITY_OR_OTHER|||||||1||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c ≤6.5%."|Fisher Exact|||||||1.000
70911014|NCT01027871|141311508|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|0.26||||0.305|TWO_SIDED|90.0|-0.16|0.67||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for morning pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.67|-0.16|0.305
70911015|NCT01027871|141311508|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.14||||0.571|TWO_SIDED|90.0|-0.54|0.26||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for morning pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.26|-0.54|0.571
70911016|NCT01027871|141311508|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.26||||0.454||90.0|-0.85|0.32||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for morning 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.32|-0.85|0.454
70911017|NCT01027871|141311508|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.83||||0.016|TWO_SIDED|90.0|-1.4|-0.26||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for morning 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||-0.26|-1.40|0.016
70911018|NCT01027871|141311508|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.07||||0.838||90.0|-0.61|0.48||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for midday pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.48|-0.61|0.838
70911019|NCT01027871|141311508|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.69||||0.033|TWO_SIDED|90.0|-1.22|-0.16||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for midday pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||-0.16|-1.22|0.033
70911020|NCT01027871|141311508|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.4||||0.229|TWO_SIDED|90.0|-0.95|0.15||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for midday 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.15|-0.95|0.229
70911021|NCT01027871|141311508|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.27||||0.412|TWO_SIDED|90.0|-0.8|0.27||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for midday 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.27|-0.80|0.412
70911022|NCT01027871|141311508|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.15||||0.642|TWO_SIDED|90.0|-0.68|0.38||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for evening pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.38|-0.68|0.642
70911023|NCT01027871|141311508|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.16||||0.614|TWO_SIDED|90.0|-0.67|0.36||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for evening pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.36|-0.67|0.614
70911024|NCT01027871|141311508|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.5||||0.147|TWO_SIDED|90.0|-1.07|0.07||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for evening 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.07|-1.07|0.147
70911025|NCT01027871|141311508|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.42||||0.21|TWO_SIDED|90.0|-0.98|0.13||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for evening 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.13|-0.98|0.210
70911026|NCT01027871|141311508|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.28||||0.438|TWO_SIDED|90.0|-0.86|0.31||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for bed time BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.31|-0.86|0.438
70911027|NCT01027871|141311508|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.7||||0.043|TWO_SIDED|90.0|-1.28|-0.13||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for bed time BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||-0.13|-1.28|0.043
70970598|NCT00531752|141447058|SUPERIORITY_OR_OTHER||LS Mean Difference|0.125|STANDARD_ERROR_OF_MEAN|0.1302||0.3414|TWO_SIDED|80.0|-0.0439|0.29385|||Mixed Models Analysis|||Week 3 (GLI): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.29385|-0.0439|0.3414
70911028|NCT01027871|141311508|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|0.24||||0.403|TWO_SIDED|90.0|-0.23|0.72||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for 0300 hours BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.72|-0.23|0.403
70911029|NCT01027871|141311508|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.29||||0.314|TWO_SIDED|90.0|-0.75|0.18||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for 0300 hours BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.18|-0.75|0.314
70911030|NCT01027871|141311510|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Fisher Exact|||||||0.046
70911031|NCT01027871|141311510|SUPERIORITY_OR_OTHER|||||||0.224||95.0||||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Fisher Exact|||||||0.224
70911032|NCT01027871|141311511|SUPERIORITY_OR_OTHER|||||||0.561||95.0||||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Negative Binomial Model|||||||0.561
70911033|NCT01027871|141311511|SUPERIORITY_OR_OTHER|||||||0.518||95.0||||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Negative Binomial Model|||||||0.518
70911034|NCT01027871|141311512|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.01||||0.938|TWO_SIDED|90.0|-0.2|0.18||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for baseline."|ANOVA||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.18|-0.20|0.938
70911035|NCT01027871|141311512|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|0.0||||0.972|TWO_SIDED|90.0|-0.18|0.19||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for baseline."|ANOVA||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.19|-0.18|0.972
70911036|NCT01027871|141311512|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.01||||0.927|TWO_SIDED|90.0|-0.16|0.15||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for Week 12."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.15|-0.16|0.927
70911037|NCT01027871|141311512|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.1||||0.293|TWO_SIDED|90.0|-0.25|0.05||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for Week 12."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.05|-0.25|0.293
70911038|NCT02084082|141311525|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|100.37|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|90.0|96.562|104.326|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fasted/ L+M 1000 fasted)|||104.326|96.562|<0.0001
70911039|NCT02084082|141311525|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio (net)|94.7|STANDARD_ERROR_OF_MEAN|1.037||0.0004|TWO_SIDED|90.0|88.712|101.089|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000 Fed/ L+M 1000 Fed)|||101.089|88.712|0.0004
70911040|NCT02084082|141311526|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|108.09|STANDARD_ERROR_OF_MEAN|1.054||0.0038|TWO_SIDED|90.0|99.022|117.989|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fasted/ L+M 1000 fasted)|||117.989|99.022|0.0038
70911041|NCT02084082|141311526|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|98.24|STANDARD_ERROR_OF_MEAN|1.024|<|0.0001|TWO_SIDED|90.0|94.067|102.597|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fed / L+M 1000 fed)|||102.597|94.067|<0.0001
70911042|NCT02084082|141311527|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|99.99|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|TWO_SIDED|90.0|93.03|107.47|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fasted/ L+M 1000 fasted)|||107.47|93.03|<0.0001
70911043|NCT02084082|141311527|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|96.95|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|92.24|101.89|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fed / L+M 1000 fed)|||101.89|92.24|<0.0001
70911044|NCT02084082|141311528|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|99.77|STANDARD_ERROR_OF_MEAN|1.046|<|0.0001|TWO_SIDED|90.0|92.464|107.645|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fasted/ L+M 1000 fasted)|||107.645|92.464|<0.0001
71153659|NCT02504216|141799958|SUPERIORITY||Hazard Ratio (HR)|0.89|||=|0.0145|TWO_SIDED|95.0|0.79|0.99||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||0.99|0.79|=0.0145
70911045|NCT02084082|141311528|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|98.97|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|90.0|94.95|103.16|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fed / L+M 1000 fed)|||103.160|94.950|<0.0001
70911046|NCT02084082|141311529|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|99.72|STANDARD_ERROR_OF_MEAN|1.028|<|0.0001|TWO_SIDED|90.0|95.163|104.493|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fasted/ L+M 1000 fasted)|||104.493|95.163|<0.0001
70911047|NCT02084082|141311529|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|97.36|STANDARD_ERROR_OF_MEAN|1.132||0.0778|TWO_SIDED|90.0|77.082|122.963|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fed / L+M 1000 fed)|||122.963|77.082|0.0778
70911048|NCT02084082|141311530|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|99.11|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|TWO_SIDED|90.0|92.37|106.35|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fasted/ L+M 1000 fasted)|||106.35|92.37|<0.0001
70911049|NCT02084082|141311530|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|98.18|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|93.34|103.27|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fed / L+M 1000 fed)|||103.27|93.34|<0.0001
70911050|NCT04736056|141311543|OTHER||Cohen's d effect size|1.2|||||TWO_SIDED|95.0|0.73|1.66||||||0 to 12 weeks||1.66|0.73|
70911051|NCT04736056|141311543|OTHER||Cohen's d effect size|1.07|||||TWO_SIDED|95.0|0.61|1.51||||||0 to 16 weeks||1.51|0.61|
70911052|NCT04736056|141311544|OTHER||Cohen's d effect size|0.35|||||TWO_SIDED|95.0|-0.02|0.71||||||0 to 12 weeks||0.71|-0.02|
70911053|NCT04736056|141311544|OTHER||Cohen's d effect size|0.25|||||TWO_SIDED|95.0|-0.12|0.61||||||0 to 16 weeks||0.61|-0.12|
70911054|NCT04736056|141311545|OTHER||Cohen's d effect size|0.78|||||TWO_SIDED|95.0|0.38|1.18||||||0 to 12 weeks||1.18|0.38|
70911055|NCT04736056|141311545|OTHER||Cohen's d effect size|0.5|||||TWO_SIDED|95.0|0.11|0.87||||||0 to 16 weeks||0.87|0.11|
70911056|NCT04736056|141311546|OTHER||Cohen's d effect size|0.23|||||TWO_SIDED|95.0|-0.13|0.58||||||0 to 12 weeks||0.58|-0.13|
70911057|NCT04736056|141311546|OTHER||Cohen's d effect size|0.31|||||TWO_SIDED|95.0|-0.05|0.68||||||0 to 16 weeks||0.68|-0.05|
70911058|NCT04736056|141311547|OTHER||Cohen's d effect size|0.32|||||TWO_SIDED|95.0|-0.04|0.68||||||0 to 12 weeks||0.68|-0.04|
70911059|NCT04736056|141311547|OTHER||Cohen's d effect size|0.61|||||TWO_SIDED|95.0|0.22|1.0||||||0 to 16 weeks||1.00|0.22|
70911060|NCT04736056|141311548|OTHER||Cohen's d effect size|0.38|||||TWO_SIDED|95.0|0.01|0.74||||||0 to 12 weeks||0.74|0.01|
70911061|NCT04736056|141311548|OTHER||Cohen's d effect size|0.47|||||TWO_SIDED|95.0|0.09|0.85||||||0 to 16 weeks||0.85|0.09|
70911062|NCT04736056|141311549|OTHER||Cohen's d effect size|0.29|||||TWO_SIDED|95.0|-0.07|0.65||||||0 to 12 weeks||0.65|-0.07|
70911063|NCT04736056|141311549|OTHER||Cohen's d effect size|0.6|||||TWO_SIDED|95.0|0.21|0.99||||||||0.99|0.21|
70911064|NCT04736056|141311550|OTHER||Cohen's d effect size|0.54|||||TWO_SIDED|95.0|0.16|0.91||||||0 to 12 weeks||0.91|0.16|
70911065|NCT04736056|141311550|OTHER||Cohen's d effect size|0.51|||||TWO_SIDED|95.0|0.12|0.89||||||0 to 16 weeks||0.89|0.12|
70911066|NCT04736056|141311551|OTHER||Cohen's d effect size|0.89|||||TWO_SIDED|95.0|0.47|1.3||||||0 to 12 weeks||1.30|0.47|
70911067|NCT04736056|141311551|OTHER||Cohen's d effect size|0.66|||||TWO_SIDED|95.0|0.26|1.05||||||0 to 16 weeks||1.05|0.26|
70970599|NCT00531752|141447058|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1044|STANDARD_ERROR_OF_MEAN|0.1418||0.4642|TWO_SIDED|80.0|-0.0793|0.28814|||Mixed Models Analysis|||Week 3 (GLI): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.28814|-0.0793|0.4642
70911068|NCT04736056|141311552|OTHER||Cohen's d effect size|-0.4|||||TWO_SIDED|95.0|-0.76|-0.03||||||0 to 12 weeks||-0.03|-0.76|
70911069|NCT04736056|141311552|OTHER||Cohen's d effect size|-0.34|||||TWO_SIDED|95.0|-0.71|0.03||||||0 to 16 weeks||0.03|-0.71|
70911070|NCT04736056|141311553|OTHER||Cohen's d effect size|0.0|||||TWO_SIDED|95.0|-0.35|0.35||||||0 to 12 weeks||0.35|-0.35|
70911071|NCT04736056|141311553|OTHER||Cohen's d effect size|-0.28|||||TWO_SIDED|95.0|-0.64|0.09||||||0 to 16 weeks||0.09|-0.64|
70911072|NCT04736056|141311554|OTHER||Cohen's d effect size|0.1|||||TWO_SIDED|95.0|-0.45|0.26||||||||0.26|-0.45|
70911073|NCT04736056|141311554|OTHER||Cohen's d effect size|0.09|||||TWO_SIDED|95.0|-0.27|0.45||||||0 to 16 weeks||0.45|-0.27|
70911074|NCT04736056|141311555|OTHER||Cohen's d effect size|-0.035|||||TWO_SIDED|95.0|-0.71|0.01||||||0 to 12 weeks||0.01|-0.71|
70911075|NCT04736056|141311555|OTHER||Cohen's d effect size|-0.29|||||TWO_SIDED|95.0|-0.65|0.08||||||0 to 16 weeks||0.08|-0.65|
70911076|NCT04736056|141311556|OTHER||Cohen's d effect size|-0.34|||||TWO_SIDED|95.0|-0.7|0.03||||||0 to 12 weeks||0.03|-0.70|
70911077|NCT04736056|141311556|OTHER||Cohen's d effect size|-0.47|||||TWO_SIDED|95.0|-0.85|-0.09||||||0 to 16 weeks||-0.09|-0.85|
70911078|NCT03437668|141311561|SUPERIORITY|To test for a differential treatment effect, we fit a linear mixed with group, time, and a group by time interaction as the predictors and random intercepts to account for the correlations induced by the repeated measurements within subjects. Given the form of the trajectories and the small sample size, we chose to treat time as continuous to minimize the number of degrees of freedom and the risk of overfitting.|Slope|-0.22||||0.31|TWO_SIDED|||||p-value is for the interaction of time and treatment group in the mixed model|Mixed Models Analysis|||||||.31
70911079|NCT00615433|141311603|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||Improvements in PANSS ratings are estimated from 2 prior studies of lurasidone. Assuming lurasidone differs from placebo in change from baseline in PANSS by 6.8 and 10.0 for 40 and 120 mg, respectively, and assuming a standard deviation of 19.1, then n=120 subjects per group provides approximately 97% power (at α=0.05, two-sided) to reject the null hypothesis of no difference from placebo for at least 1 dose. This calculation uses Bonferroni's procedure for controlling pairwise differences.||||<0.05
70911080|NCT00615433|141311604|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Mixed Models Analysis|||||||<0.05
70911081|NCT03194776|141311606|SUPERIORITY||Mean Difference (Final Values)|-17.74|||=|0.2612|TWO_SIDED|80.0|-38.03|2.55||P-value of \<= 0.2 was considered significant.|two-sided test|||Statistical analysis was done by mixed effect model repeat measurement (MMRM) model analysis.||2.55|-38.03|= 0.2612
70911082|NCT01823341|141311623|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
70911083|NCT01823341|141311624|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||||||0.01
70911084|NCT01823341|141311624|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||0.04
70911085|NCT01823341|141311625|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
70911086|NCT01823341|141311625|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||t-test, 2 sided|||||||0.005
70911087|NCT01823341|141311626|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
70911088|NCT01823341|141311626|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||||||0.004
70911089|NCT01823341|141311627|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||t-test, 2 sided|||||||0.10
70911090|NCT01823341|141311627|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.50
70911091|NCT01823341|141311628|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||t-test, 2 sided|||||||0.18
70911092|NCT01823341|141311628|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||t-test, 2 sided|||||||0.77
70911093|NCT01823341|141311629|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
70911094|NCT01823341|141311629|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||t-test, 2 sided|||||||0.11
70911095|NCT01823341|141311630|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||t-test, 2 sided|||||||0.57
70911096|NCT01823341|141311630|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||t-test, 2 sided|||||||0.18
70911097|NCT01823341|141311631|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||t-test, 2 sided|||||||0.16
70911098|NCT01823341|141311631|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||t-test, 2 sided|||||||0.39
70911099|NCT01823341|141311632|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||t-test, 2 sided|||||||0.53
70911100|NCT01823341|141311632|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||t-test, 2 sided|||||||0.28
70911101|NCT01394991|141311657|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.018||||0.248|TWO_SIDED|95.0|-0.051|0.016|||Chi-squared|||The primary hypothesis was that the group of participants receiving epoetin alfa QW and the group of participants receiving epoetin alfa TIW would have similar incidence rate of participants with at least 1 clinically relevant and objectively confirmed TVE from randomization through Week 16.||0.016|-0.051|0.248
70911102|NCT01394991|141311657|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53||||0.254||95.0|0.18|1.58|||Regression, Logistic|||||1.58|0.18|0.254
70911103|NCT01394991|141311658|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.029||||0.08|TWO_SIDED|95.0|-0.065|0.007|||Chi-squared|||||0.007|-0.065|0.08
70911104|NCT01394991|141311659|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||0.073|TWO_SIDED|95.0|0.14|1.13|||Log Rank|The stratified log-rank test accounting for ECOG performance status (0 or 1 versus 2) was used to compare the difference between treatment groups.|The Cox regression model with covariates for treatment group and Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1 versus 2) was used for estimates of hazard ratio and its 95% confidence interval.|||1.13|0.14|0.073
70911105|NCT01394991|141311660|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.039||||0.059||95.0|-0.083|0.005|||Chi-squared|||||0.005|-0.083|0.059
70911106|NCT01394991|141311661|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.47||||0.054|TWO_SIDED|95.0|0.21|1.03|||Log Rank|The stratified log-rank test accounting for ECOG score status (0 or 1 versus 2) was used to compare the difference between treatment groups.|The Cox regression model including covariates for treatment group and the Eastern Cooperative Oncology Group (ECOG) score status (0 or 1 versus 2) was used for estimates of a hazard ratio and its 95% confidence interval.|||1.03|0.21|0.054
70911107|NCT01394991|141311662|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0041||||0.88||95.0|-0.0526|0.0608|||Chi-squared|||||0.0608|-0.0526|0.88
70911108|NCT01394991|141311663|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.026||||0.514|TWO_SIDED|95.0|-0.056|0.108|||Chi-squared|||||0.108|-0.056|0.514
70911109|NCT01394991|141311664|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.003||||0.92|TWO_SIDED|95.0|-0.071|0.065|||Chi-squared|||||0.065|-0.071|0.920
70911110|NCT01324882|141311674|OTHER|||||||1|||||||Fisher Exact|||||||1.00
70911111|NCT01290094|141311677|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED|||||P-value for percent change from baseline was from a paired samples t-test.|Paired t-test|||||||<0.0005
70911112|NCT01290094|141311678|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED|||||P-value for percent change from baseline was from a paired samples t-test.|Paired t-test|||||||<0.0005
70911113|NCT01290094|141311679|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value for percent change from baseline was from a paired samples t-test.|Paired t-test|||||||0.001
70911114|NCT01290094|141311680|SUPERIORITY_OR_OTHER|||||||0.056|TWO_SIDED|||||P-value for percent change from baseline was from a paired samples t-test.|Paired t-test|||||||0.056
70911115|NCT01290094|141311681|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED|||||Month 12: P-value for percent change from baseline was from a Wilcoxon signed rank test.|Wilcoxon signed rank test|||||||<0.0005
70911116|NCT01290094|141311681|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED|||||Month 24: P-value for percent change from baseline was from a Wilcoxon signed rank test.|Wilcoxon signed rank test|||||||<0.0005
70911117|NCT01290094|141311682|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED|||||Month 12: P-value for percent change from baseline was from a paired samples t-test.|Paired t-test|||||||<0.0005
70911118|NCT01290094|141311682|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED|||||Month 24: P-value for percent change from baseline was from a paired samples t-test.|Paired t-test|||||||0.027
70911119|NCT04949399|141311694|SUPERIORITY||Difference (%)|30.4|||<|0.0001|TWO_SIDED|95.0|23.5|37.2||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||37.2|23.5|<.0001
70911120|NCT04949399|141311695|SUPERIORITY||Difference (%)|39.8|||<|0.0001|TWO_SIDED|95.0|32.0|47.7||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||47.7|32.0|<0.0001
70911121|NCT04949399|141311696|SUPERIORITY||Difference (%)|41.6|||<|0.0001|TWO_SIDED|95.0|33.7|49.6||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||49.6|33.7|<0.0001
70911122|NCT04949399|141311699|SUPERIORITY||Difference (%)|54.8|||<|0.0001|TWO_SIDED|95.0|46.8|62.8||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||62.8|46.8|<.0001
70911123|NCT04949399|141311700|SUPERIORITY||Difference (%)|39.1|||<|0.0001|TWO_SIDED|95.0|30.5|47.8||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||47.8|30.5|<.0001
70911124|NCT04949399|141311701|SUPERIORITY||Difference (%)|44.6|||<|0.0001|TWO_SIDED|95.0|36.8|52.5||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||52.5|36.8|<.0001
70911125|NCT04949399|141311702|SUPERIORITY||Difference (SE)|-5.7|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|-6.7|-4.7||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||||-4.7|-6.7|<.0001
70911126|NCT04949399|141311705|SUPERIORITY||Difference (%)|46.1|||<|0.0001|TWO_SIDED|96.0|38.1|54.2||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||54.2|38.1|<0.0001
71153660|NCT02504216|141799959|SUPERIORITY||Hazard Ratio (HR)|0.86|||=|0.0051|TWO_SIDED|95.0|0.76|0.96||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||0.96|0.76|=0.0051
70911127|NCT04949399|141311706|SUPERIORITY||Difference (%)|51.9|||<|0.0001|TWO_SIDED|95.0|43.3|60.5||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||60.5|43.3|<0.0001
70911128|NCT04949399|141311707|SUPERIORITY||Difference (%)|40.1|||<|0.0001|TWO_SIDED|95.0|31.3|49.0||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||49.0|31.3|<0.0001
70911129|NCT04949399|141311708|SUPERIORITY||Difference (%)|45.2|||<|0.0001|TWO_SIDED|95.0|37.1|53.2||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||53.2|37.1|<0.0001
70911130|NCT04949399|141311709|SUPERIORITY||Difference (SE)|-5.7|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-6.8|-4.6||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||||-4.6|-6.8|<0.0001
70911131|NCT04949399|141311710|SUPERIORITY||Difference (SE)|-5.6|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|-6.7|-4.5||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||Day 30||-4.5|-6.7|<0.0001
70911132|NCT04949399|141311710|SUPERIORITY||Difference (SE)|-5.0|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-6.0|-3.9||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||Day 60||-3.9|-6.0|<0.0001
70911133|NCT04949399|141311710|SUPERIORITY||Difference (SE)|-3.9|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|-4.9|-2.8||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||Day 90||-2.8|-4.9|<0.0001
70911134|NCT04091672|141311724|NON_INFERIORITY|"The one-sided 97.5% confidence interval (97.5% CI) was calculated for the difference (Control-RECELL) in percentages of subjects with confirmed treatment area closure.~The calculation used the normal approximation taking correlation into account. In order for the null hypothesis to be rejected and the non-inferiority of RECELL to be established, the upper limit of the 97.5% CI had to be less than 10%."||||||0.005|||||||1-sided z-test of proportions|alpha=0.025||||||.005
70911135|NCT04091672|141311725|SUPERIORITY|A geometric mean ratio (GMR of ratios) 95% CI with a lower bound exceeding 1 would indicate superiority of RECELL over Control with respect to this endpoint.||||||0.001|||||||GMR of ratios|||||||0.001
70911136|NCT02401529|141311741|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||Chi-squared|||||||0.033
70911137|NCT02401529|141311742|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED||||||Chi-squared|||||||0.026
70911138|NCT02401529|141311743|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||Chi-squared|||||||0.016
70911139|NCT02401529|141311744|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||Chi-squared|||||||0.019
70911140|NCT02401529|141311745|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Chi-squared|||||||0.012
70911141|NCT02401529|141311746|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED||||||Chi-squared|||||||0.024
70911142|NCT02401529|141311747|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||||||0.02
70911143|NCT02401529|141311748|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED||||||Chi-squared|||||||0.017
70911144|NCT02401529|141311749|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED||||||Chi-squared|||||||0.026
70911145|NCT02401529|141311750|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||Chi-squared|||||||0.019
70911146|NCT00961805|141311754|SUPERIORITY_OR_OTHER||||||<|0.001||||||Differences in the behavior of the groups over time.|ANOVA|||"Sample size was calculated by visual analogue scale for pain (alpha error of 5%, beta error of 20% and standard deviation of 2). The sample was determined to contain 30 patients in each group. Ten additional patients were added to compensate possible losses.~Analysis was intention to treat using the LOCF technique."||||<0.001
70911147|NCT00961805|141311755|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||<0.001
70911148|NCT00961805|141311756|SUPERIORITY_OR_OTHER||||||<|0.003||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||<0.003
70911149|NCT00961805|141311757|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.146
70911150|NCT00961805|141311758|SUPERIORITY_OR_OTHER|||||||0.131||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.131
70911151|NCT00961805|141311759|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||<0.001
70911152|NCT00961805|141311760|SUPERIORITY_OR_OTHER|||||||0.58||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.580
70911153|NCT00961805|141311761|SUPERIORITY_OR_OTHER|||||||0.082||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.082
70911154|NCT00961805|141311762|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.055
70911155|NCT00961805|141311763|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.003
70911156|NCT00961805|141311764|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.021
70911157|NCT00961805|141311765|SUPERIORITY_OR_OTHER|||||||0.136||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.136
70911158|NCT00961805|141311766|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.009
70911159|NCT02949271|141311767|OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
70911160|NCT02949271|141311768|OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
70911161|NCT02949271|141311770|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
70911162|NCT02949271|141311771|OTHER|||||||0.28|||||||Chi-squared|||||||0.28
70911163|NCT02949271|141311772|OTHER|||||||0.85|||||||Chi-squared|||||||0.85
70911164|NCT02949271|141311773|OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
70911165|NCT02949271|141311774|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
70911166|NCT02949271|141311775|OTHER|||||||0.21|||||||Chi-squared|||||||0.21
70911167|NCT02949271|141311777|OTHER|||||||0.08|||||||Chi-squared|||||||0.08
70911168|NCT05458102|141311783|OTHER||Geometric Least-squares Mean Ratio|560.0|||||TWO_SIDED|90.0|414.0|757.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||757|414|
70911169|NCT05458102|141311783|OTHER||Geometric Least-squares Mean Ratio|137.0|||||TWO_SIDED|90.0|99.5|189.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||189|99.5|
70911170|NCT05458102|141311784|OTHER||Geometric Least-squares Mean Ratio|433.0|||||TWO_SIDED|90.0|347.0|540.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||540|347|
70911171|NCT05458102|141311784|OTHER||Geometric Least-squares Mean Ratio|118.0|||||TWO_SIDED|90.0|93.5|150.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||150|93.5|
70911172|NCT05458102|141311785|OTHER||Geometric Least-squares Mean Ratio|752.0|||||TWO_SIDED|90.0|525.0|1080.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||1080|525|
70911173|NCT05458102|141311785|OTHER||Geometric Least-squares Mean Ratio|118.0|||||TWO_SIDED|90.0|80.3|172.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||172|80.3|
70911174|NCT05458102|141311787|OTHER||Geometric Least-squares Mean Ratio|68.5|||||TWO_SIDED|90.0|45.5|103.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||103|45.5|
70911175|NCT05458102|141311787|OTHER||Geometric Least-squares Mean Ratio|65.4|||||TWO_SIDED|90.0|42.5|101.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||101|42.5|
70911176|NCT05458102|141311791|OTHER||Geometric Least-squares Mean Ratio|120.0|||||TWO_SIDED|90.0|104.0|138.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||138|104|
70911177|NCT05458102|141311791|OTHER||Geometric Least-squares Mean Ratio|111.0|||||TWO_SIDED|90.0|95.4|128.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||128|95.4|
70911178|NCT03371108|141311804|EQUIVALENCE|The determination of equivalence was defined by the US-FDA as a confidence interval that was contained within the equivalence limits of +/- 10.7.|Risk Difference (RD)|-2.1|STANDARD_ERROR_OF_MEAN|3.39|||TWO_SIDED|90.0|-7.6|3.5|||||The asymptotic standard error was planned and is reported above.|This is a two-arm study.||3.5|-7.6|
70911179|NCT02790606|141311819|SUPERIORITY|||||||0.0021|||||||Exact binomial test|||"The primary safety endpoint is evaluated against a PG of 88%, which was derived from safety event rates of PTA in published literature.~Hypothesis: The safety rate in subjects treated with the COVERA™ Vascular Covered Stent (following PTA) at 30 days post-index procedure is greater than that of the PG of 88%. 109 treated subjects \[104 evaluable\] will give 99% power with one-sided type I error = 0.05."||||0.0021
70911180|NCT02790606|141311820|SUPERIORITY||||||<|0.0001||||||The p-value is compared to the PG (40%) and computed using the exact binomial test.|Exact binomial test|||"The primary effectiveness endpoint is evaluated against a PG of 40%, which was derived from clinical literature as well as other pivotal and post-market studies of stent grafts at the graft-vein anastomosis of AV access patients dialyzing with an AV graft. 89% estimated power for primary endpoint.~Hypothesis: The proportion of subjects treated with the COVERA™ Vascular Covered Stent (following PTA) with respect to TLPP through 6 months post-index procedure is greater than that of the PG of 40%."||||<0.0001
70911181|NCT03929302|141311864|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.05|TWO_SIDED||||||Regression, Linear|||||||0.05
70911182|NCT03929302|141311864|SUPERIORITY||Mean Difference (Final Values)|1.57||||0.2|TWO_SIDED||||||Regression, Linear|||||||0.20
70911183|NCT03929302|141311864|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.642|TWO_SIDED||||||Regression, Linear|||||||0.642
70911184|NCT03815916|141311865|SUPERIORITY||Mean Difference (Final Values)|0.3865||||0.1077|TWO_SIDED||||||t-test, 2 sided|||The primary efficacy endpoint is the mean change in the average NAD+/NADH brain ratio from baseline to Week 12 using a partial volume coil 31P-MRS data on the Per Protocol Treatment Population. A paired t-test will be used to analyze the mean change from baseline.||||0.1077
70911185|NCT01072929|141311957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8||||0.0097|TWO_SIDED|95.0|-6.58|-0.92||All statistical tests were 2-tailed at the 0.05 level of significance.|mixed-model repeated measures (MMRM)|Treatment, visit, treatment-by-visit interaction, concurrent mood-stabilizing medication, and region of the world used as fixed factors.||||-0.92|-6.58|0.0097
70911186|NCT01072929|141311957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9||||0.0385|TWO_SIDED|95.0|-5.71|-0.16||All statistical tests were 2-tailed at the 0.05 level of significance.|mixed-model repeated measures (MMRM)|Treatment, visit, treatment-by-visit interaction, concurrent mood-stabilizing medication, and region of the world used as fixed factors.||||-0.16|-5.71|0.0385
70911187|NCT02783950|141312018|SUPERIORITY|||||||0.27|||||||Chi-squared|||||||0.27
70911188|NCT02783950|141312019|SUPERIORITY|||||||0.7|||||||Wilcoxon Rank Test p-value|||||||0.70
70911189|NCT02487446|141312044|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the lower limit (LL) of the 97.5% one -sided confidence interval (CI) \> -20 mL.|Mean Difference (Net)|-0.0115|STANDARD_ERROR_OF_MEAN|0.00778||0.139|TWO_SIDED|95.0|-0.0269|0.0038||p-value unadjusted|Linear Mixed Model|||Ho: QVA149 27.5/12.5 μg b.i.d. is inferior to umeclidinium/vilanterol 62.5/25 μg q.d; Ha: QVA149 27.5/12.5 μg b.i.d. is non-inferior to umeclidinium/vilanterol 62.5/25 μg q.d.||0.0038|-0.0269|0.139
70911190|NCT02487446|141312045|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0115|STANDARD_ERROR_OF_MEAN|0.00778|||TWO_SIDED|95.0|-0.0269|0.0038||||||Ho: QVA149 27.5/12.5 μg b.i.d. is inferior to umeclidinium/vilanterol 62.5/25 μg q.d; Ha: QVA149 27.5/12.5 μg b.i.d. is non-inferior to umeclidinium/vilanterol 62.5/25 μg q.d.||0.0038|-0.0269|
70911191|NCT02487446|141312046|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0153|STANDARD_ERROR_OF_MEAN|0.01062|||TWO_SIDED|95.0|-0.0361|0.0056||||||||0.0056|-0.0361|
70911192|NCT02487446|141312047|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0051|STANDARD_ERROR_OF_MEAN|0.00806|||TWO_SIDED|95.0|-0.0108|0.0209||||||||0.0209|-0.0108|
70911193|NCT04438785|141312053|SUPERIORITY||Mean Difference (Final Values)|2.58|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Evaluate if the Apnea Hypopnea Index from Baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||<0.001
70911194|NCT04438785|141312054|SUPERIORITY||Median Difference (Final Values)|-0.971||||0.003|TWO_SIDED||||||t-test, 2 sided|||Evaluate if the O2 desaturation index (ODI) from Baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.003
71153661|NCT02504216|141799960|SUPERIORITY||Hazard Ratio (HR)|1.08|||=|0.8322|TWO_SIDED|95.0|0.92|1.27||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||1.27|0.92|=0.8322
70911195|NCT04438785|141312055|SUPERIORITY||Mean Difference (Net)|-0.364||||0.001|ONE_SIDED||||||t-test, 2 sided|||Evaluate if the IOPI tongue score from baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.001
70911196|NCT04438785|141312056|SUPERIORITY||Median Difference (Final Values)|-1.131||||0.001|ONE_SIDED|95.0|||||t-test, 2 sided|||Evaluate if the IOPI lip score from the baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.001
70911197|NCT04438785|141312057|SUPERIORITY||Mean Difference (Final Values)|0.98||||0.92|ONE_SIDED|95.0|||||t-test, 2 sided|||Evaluate if the neck circumference from Baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.92
70911198|NCT04438785|141312058|SUPERIORITY||Mean Difference (Final Values)|0.98||||0.92|ONE_SIDED||||||t-test, 2 sided|||Evaluate if the waist circumference from baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.92
70911199|NCT04438785|141312059|SUPERIORITY||Mean Difference (Final Values)|0.97||||0.98|ONE_SIDED|95.0|||||t-test, 2 sided|||Evaluate if the BMI from Baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.98
70911200|NCT04438785|141312060|SUPERIORITY||Median Difference (Final Values)|-1.23||||0.001|ONE_SIDED|95.0|||||t-test, 2 sided|||Evaluate if the Epworth Sleepiness Scale from Baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.001
70911201|NCT04438785|141312061|SUPERIORITY||Mean Difference (Net)|0.98||||0.22|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Evaluate if the Pittsburgh sleep quality index from Baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.22
70911202|NCT04011033|141312062|OTHER||Hazard Ratio (HR)|0.32|||<|0.001|TWO_SIDED|95.0|0.16|0.63|||Log Rank|||||0.63|0.16|<0.001
70911203|NCT04011033|141312064|OTHER||||||=|0.003|||||||Fisher Exact|||||||=0.003
70911204|NCT04011033|141312065|OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
70911205|NCT04011033|141312067|OTHER||Hazard Ratio (HR)|0.37|||=|0.001|TWO_SIDED|95.0|0.19|0.71|||Log Rank|||||0.71|0.19|=0.001
70911206|NCT00689104|141312068|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41||||0.003|TWO_SIDED|95.0|-0.72|-0.09||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.09|-0.72|0.003
70911207|NCT00689104|141312068|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.29||||0.01|TWO_SIDED|95.0|-0.61|0.03||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||0.03|-0.61|0.010
71153662|NCT02504216|141799961|SUPERIORITY||Hazard Ratio (HR)|0.61|||=|0.0235|TWO_SIDED|95.0|0.37|1.0||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||1.00|0.37|=0.0235
71153663|NCT02504216|141799962|OTHER||Hazard Ratio (HR)|1.42|||=|0.0068|TWO_SIDED|95.0|1.1|1.84|||Log Rank|||||1.84|1.10|=0.0068
70911208|NCT00689104|141312068|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.11|TWO_SIDED|95.0|-0.42|0.21||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate||Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.||0.21|-0.42|0.11
70911209|NCT00689104|141312069|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6|||<|0.001|TWO_SIDED|95.0|-0.9|-0.29||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.29|-0.90|<0.001
70911210|NCT00689104|141312069|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44||||0.005|TWO_SIDED|95.0|-0.74|-0.13||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.13|-0.74|0.005
70911211|NCT00689104|141312069|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25||||0.11|TWO_SIDED|95.0|-0.55|0.06||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.||0.06|-0.55|0.11
70911212|NCT00689104|141312070|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.9|||<|0.001|TWO_SIDED|95.0|6.3|17.4||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||17.4|6.3|<0.001
70911213|NCT00689104|141312070|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|13.2|||<|0.001|TWO_SIDED|95.0|7.7|18.7||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||18.7|7.7|<0.001
70911214|NCT00689104|141312070|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|12.6|||<|0.001|TWO_SIDED|95.0|7.1|18.2||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.||18.2|7.1|<0.001
70911215|NCT00689104|141312071|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39||||0.002|TWO_SIDED|95.0|-0.71|-0.06||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.06|-0.71|0.002
70911216|NCT00689104|141312071|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.38||||0.002|TWO_SIDED|95.0|-0.71|-0.05||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.05|-0.71|0.002
70911217|NCT00689104|141312071|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-0.35||||0.019|TWO_SIDED|95.0|-0.68|-0.03||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.||-0.03|-0.68|0.019
70970600|NCT00531752|141447058|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06109|STANDARD_ERROR_OF_MEAN|0.09093||0.5049|TWO_SIDED|80.0|-0.0571|0.17926|||Mixed Models Analysis|||Week 3 (RTI): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.17926|-0.0571|0.5049
71092388|NCT02832037|141691173|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.||||||0.0089||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|Model assumption: 20% of the maximum effect is achieved at 2 mg of BI 425809 .||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0089
71092389|NCT02832037|141691173|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.||||||0.0038||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|Model assumption: 25% of the maximum effect is achieved at 5 mg and 75% of the maximum effect is achieved at 10 mg of BI 425809.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0038
71092390|NCT02832037|141691173|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.||||||0.0085||||||Adjusted for multiplicity.|MCP-Mod logistic model fit|Model assumption: 10% of the maximum effect is achieved at 5 mg and 50% of the maximum effect is achieved at 10 mg of BI 425809.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0085
71092391|NCT02832037|141691173|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.||||||0.228||||||Adjusted for multiplicity.|MCP-Mod beta model fit|Assumption:75% of maximum (max) effect at 2mg, 87.5% of max effect at 5mg,25% of max effect at 25mg,max effect at 10mg BI 425809, scalar parameter=26.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.2280
71092392|NCT02832037|141691173|OTHER|Mixed Model Repeated Measures included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.|Difference of adjusted means|0.28|STANDARD_ERROR_OF_MEAN|0.8205||0.733|TWO_SIDED|95.0|-1.332|1.892||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||1.892|-1.332|0.7330
71092393|NCT02832037|141691173|OTHER|Mixed Model Repeated Measures included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.|Difference of adjusted means|0.137|STANDARD_ERROR_OF_MEAN|0.8074||0.8655|TWO_SIDED|95.0|-1.45|1.724||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||1.724|-1.450|0.8655
71092394|NCT02832037|141691173|OTHER|Mixed Model Repeated Measures included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.|Difference of adjusted means|1.982|STANDARD_ERROR_OF_MEAN|0.7875||0.0122|TWO_SIDED|95.0|0.434|3.53||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||3.530|0.434|0.0122
71092395|NCT02832037|141691173|OTHER|Mixed Model Repeated Measures included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.|Difference of adjusted means|1.73|STANDARD_ERROR_OF_MEAN|0.7884||0.0287|TWO_SIDED|95.0|0.181|3.28||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||3.280|0.181|0.0287
71153664|NCT02504216|141799963|OTHER||Hazard Ratio (HR)|1.29|||=|0.0979|TWO_SIDED|95.0|0.95|1.76|||Log Rank|||||1.76|0.95|=0.0979
70911218|NCT00689104|141312072|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-0.4||||0.004|TWO_SIDED|95.0|-0.66|-0.13||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.13|-0.66|0.004
70911219|NCT00689104|141312072|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.79|-0.26||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.26|-0.79|<0.001
70911220|NCT00689104|141312072|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33||||0.016|TWO_SIDED|95.0|-0.6|-0.06||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.||-0.06|-0.60|0.016
70911221|NCT03253653|141312208|OTHER||z score|1.578||||0.115|TWO_SIDED||||||Wilcoxon signed-rank test||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in biomarker levels for the Charcoal-heated tobacco smoking session (n=50) significantly different from the pre-to-post change in biomarker levels for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||0.115
70911222|NCT03253653|141312209|OTHER||z|0.497||||0.619|TWO_SIDED||||||z||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in biomarker levels for the Charcoal-heated tobacco smoking session (n=50) significantly different from the pre-to-post change in biomarker levels for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||0.619
70911223|NCT03253653|141312210|OTHER||z|1.72||||0.085|TWO_SIDED||||||Wilcox and signed rank test||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in biomarker levels for the Charcoal-heated tobacco smoking session (n=50) significantly different from the pre-to-post change in biomarker levels for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||0.085
70911224|NCT03253653|141312211|OTHER||z|6.154|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in biomarker levels for the Charcoal-heated tobacco smoking session (n=50) significantly different from the pre-to-post change in biomarker levels for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||<0.001
70911225|NCT03253653|141312212|OTHER||z|-1.144||||0.253|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in systolic blood pressure for the Charcoal-heated tobacco smoking session (n=50) significantly different from the pre-to-post change in biomarker levels for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||0.253
70911226|NCT03253653|141312213|OTHER||z|-1.004||||0.315|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in diastolic blood pressure for the Charcoal-heated tobacco smoking session (n=50) significantly different from the pre-to-post change in diastolic blood pressure for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||0.315
70911227|NCT03253653|141312214|OTHER||z|3.089||||0.002|TWO_SIDED||||||Wilcox and signed rank test||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in heart rate for the Charcoal-heated tobacco smoking session (n=50) was significantly different from the pre-to-post change in heart rate for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||0.002
70911228|NCT03253653|141312215|OTHER||z|-7.024|||<|0.001|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the cotinine metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||<0.001
70911229|NCT03253653|141312216|OTHER||z|-4.541|||<|0.001|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the SPMA metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||<0.001
70911230|NCT03253653|141312217|OTHER||z|-2.569||||0.01|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the 1-HOP metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||.010
70911231|NCT03253653|141312218|OTHER||z|-7.03|||<|0.001|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the exhaled carbon monoxide after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||<0.001
70911232|NCT03253653|141312219|OTHER||z|-1.304||||0.192|TWO_SIDED||||||Mann-Whitney U test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the cotinine metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.192
70911233|NCT03253653|141312220|OTHER||z|-2.136||||0.033|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level diastolic blood pressure after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.033
70911234|NCT03253653|141312221|OTHER||z|-1.22||||0.223|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the heart rate after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.223
70911235|NCT03253653|141312222|OTHER||z|-7.024|||<|0.001|TWO_SIDED||||||Mann Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the cotinine metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||<0.001
70911236|NCT03253653|141312223|OTHER||z|-1.248||||0.212|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the SPMA metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.212
70911237|NCT03253653|141312224|OTHER||z|-2.721||||0.007|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the cotinine metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.007
70911238|NCT03253653|141312225|OTHER||z|2.778||||0.006|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of exhaled carbon monoxide after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.006
70911239|NCT03253653|141312226|OTHER||z|-0.832||||0.406|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of systolic blood pressure after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.406
70911240|NCT03253653|141312227|OTHER||z|-1.467||||0.142|TWO_SIDED||||||Mann-Whitney U ranksum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of diastolic blood pressure after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.142
70911241|NCT03253653|141312228|OTHER||z|-0.596||||0.551|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the heart rate after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.551
70911242|NCT03253653|141312229|OTHER||z|-0.787||||0.431|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.431
70911243|NCT03253653|141312230|OTHER||z|-0.652||||0.515|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.515
70911244|NCT03253653|141312231|OTHER||z|-2.394||||0.017|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0. 017
71153665|NCT02093819|141799993|SUPERIORITY_OR_OTHER||Slope|1.1313|STANDARD_ERROR_OF_MEAN|0.0633|||TWO_SIDED|90.0|1.0249|1.2376|||||Evaluation of dose proportionality - all dose groups. Number of subjects included in the analysis=44.|A power model was used to describe functional relationship between dose and Pk parameters. For the evaluation of dose proportionality,slope parameter (B), a two-sided 90% confidence interval of the slope was calculated. Perfect dose proportionality would correspond to a slope of 1.||1.2376|1.0249|
70911245|NCT03253653|141312232|OTHER||z|-1.286||||0.199|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.199
70911246|NCT03253653|141312233|OTHER||z|-3.091||||0.002|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.002
70911247|NCT03253653|141312234|OTHER||z|0.13||||0.896|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level pre the tobacco smoking session.|||0.896
70911248|NCT03253653|141312235|OTHER||z|-0.362||||0.717|TWO_SIDED||||||The Wilcoxon signed rank test||||We used the Wilcoxon signed rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level pre the tobacco smoking session.|||0.717
70911249|NCT03253653|141312236|OTHER||z|2.233||||0.026|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level pre the tobacco smoking session.|||0.026
70911250|NCT03253653|141312237|OTHER||z|0.383||||0.702|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level pre the tobacco smoking session.|||0.702
70911251|NCT03253653|141312238|OTHER||z|2.244||||0.025|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level pre the tobacco smoking session.|||0.025
70911252|NCT00662909|141312242|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34||||0.026|TWO_SIDED|95.0|-0.66|-0.03||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.03|-0.66|0.026
70911253|NCT00662909|141312242|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|||<|0.001|TWO_SIDED|95.0|-0.82|-0.18||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.18|-0.82|<0.001
70911254|NCT00662909|141312243|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61||||0.001|TWO_SIDED|95.0|-0.98|-0.24||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.24|-0.98|0.001
70911255|NCT00662909|141312243|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|||<|0.001|TWO_SIDED|95.0|-1.07|-0.33||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.33|-1.07|<0.001
70911256|NCT00662909|141312244|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.1||||0.001|TWO_SIDED|95.0|4.4|17.9||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||17.9|4.4|0.001
70911257|NCT00662909|141312244|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.0||||0.002|TWO_SIDED|95.0|4.2|17.7||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||17.7|4.2|0.002
70911258|NCT00662909|141312245|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48||||0.003|TWO_SIDED|95.0|-0.8|-0.15||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.15|-0.80|0.003
70911259|NCT00662909|141312245|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|||<|0.001|TWO_SIDED|95.0|-0.79|-0.13||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.13|-0.79|<0.001
70911260|NCT00662909|141312246|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.42||||0.022|TWO_SIDED|95.0|-0.77|-0.06||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.06|-0.77|0.022
70911261|NCT00662909|141312246|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.001|TWO_SIDED|95.0|-0.96|-0.24||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.24|-0.96|0.001
70911262|NCT04672460|141312355|OTHER||Ratio (Test/Reference) of Adjusted Means|105.16|||||TWO_SIDED|90.0|99.0|111.7|||Mixed Models Analysis|||Treatment A were reference; treatment B were test.||111.70|99.00|
70911263|NCT04672460|141312356|OTHER||Ratio (Test/Reference) of Adjusted Means|136.62|||||TWO_SIDED|90.0|125.05|149.27|||Mixed Models Analysis|||Treatment A were reference; treatment B were test.||149.27|125.05|
70911264|NCT04672460|141312357|OTHER||Ratio (Test/Reference) of Adjusted Means|87.97|||||TWO_SIDED|90.0|81.82|94.58|||Mixed Models Analysis|||Treatment B were reference; treatment C were test.||94.58|81.82|
70911265|NCT04672460|141312358|OTHER||Ratio (Test/Reference) of Adjusted Means|58.26|||||TWO_SIDED|90.0|51.55|65.84|||Mixed Models Analysis|||Treatment B were reference; treatment C were test.||65.84|51.55|
70911266|NCT03575962|141312366|OTHER||Ratio of geometric least square mean|1.1169|||||TWO_SIDED|90.0|0.99|1.27||||||||1.27|0.99|
70911267|NCT03575962|141312367|OTHER||Ratio of geometric least square mean|1.1556|||||TWO_SIDED|90.0|0.99|1.35||||||||1.35|0.99|
70911268|NCT02054247|141312411|SUPERIORITY|||||||0.442|||||||ANOVA|||||||0.442
70911269|NCT02054247|141312412|SUPERIORITY|||||||0.083|||||||ANOVA|||||||0.083
70911270|NCT02054247|141312413|SUPERIORITY|||||||0.125|||||||ANOVA|||||||0.125
71092396|NCT02832037|141691174|OTHER|Analysis of covariance (ANCOVA) model estimates were used as input for the MCP-Mod. ANCOVA included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.||||||0.066||||||P-value is considered nominal.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0660
71092397|NCT02832037|141691174|OTHER|Analysis of covariance (ANCOVA) model estimates were used as input for the MCP-Mod. ANCOVA included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.||||||0.1619||||||P-value is considered nominal.|MCP-Mod linear in log model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1619
71092398|NCT02832037|141691174|OTHER|Analysis of covariance (ANCOVA) model estimates were used as input for the MCP-Mod. ANCOVA included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.||||||0.0832||||||P-value is considered nominal.|MCP-Mod Emax model fit|Model assumption: 20% of the maximum effect is achieved at 2 mg of BI 425809.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0832
70911271|NCT02054247|141312414|SUPERIORITY|||||||0.146|||||||ANOVA|||||||0.146
70911272|NCT01195675|141312420|NON_INFERIORITY_OR_EQUIVALENCE|Empa vs placebo|Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|90.0|-0.69|1.87|||ANCOVA|Based on ANCOVA with terms for sequence, subjects within sequence, period, treatment and baseline.|Mean difference = Empa minus placebo|Non-inferiority margin: 10ms||1.87|-0.69|
70911273|NCT01195675|141312421|NON_INFERIORITY_OR_EQUIVALENCE|Empa vs placebo. Non-confirmatory testing.|Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|90.0|-0.38|1.71|||ANCOVA|Based on ANCOVA with terms for sequence, subjects within sequence, period, treatment and baseline.|Mean difference = Empa minus placebo|Non-inferiority margin: 10ms||1.71|-0.38|
70911274|NCT01195675|141312422|NON_INFERIORITY_OR_EQUIVALENCE|Empa vs placebo. Non-confirmatory testing.|Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|90.0|-1.23|0.93|||ANCOVA|Based on ANCOVA with terms for sequence, subjects within sequence, period, treatment and baseline.|Mean difference = Empa minus placebo|Non-inferiority margin: 10ms||0.93|-1.23|
70911275|NCT01195675|141312423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.42|STANDARD_ERROR_OF_MEAN|1.01|<|0.0001|TWO_SIDED|90.0|10.73|14.11|||ANCOVA|Based on ANCOVA with terms for treatment, period, treatment sequence, baseline and subject within sequence.|Non-confirmatory testing. Mean difference = Moxifloxacin minus placebo.|||14.11|10.73|<0.0001
70911276|NCT01195675|141312424|NON_INFERIORITY_OR_EQUIVALENCE|Empa vs placebo. Non-confirmatory testing.|Mean Difference (Final Values)|2.16|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-0.34|4.67|||Repeated measures analysis|Based on repeated measured analysis with terms for subject, baseline, period, treatment, time, baseline by time, period by time and treatment by time.|Mean difference = Empa minus placebo|Non-inferiority margin: 10ms||4.67|-0.34|
70911277|NCT01195675|141312425|NON_INFERIORITY_OR_EQUIVALENCE|Empa vs placebo. Non-confirmatory testing.|Mean Difference (Final Values)|1.59|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-0.35|3.53|||Repeated measures analysis|Based on repeated measured analysis with terms for subject, baseline, period, treatment, time, baseline by time, period by time and treatment by time.|Mean difference = Empa minus placebo|Non-inferiority margin: 10ms||3.53|-0.35|
70911278|NCT01195675|141312426|NON_INFERIORITY_OR_EQUIVALENCE|Empa vs placebo|Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|90.0|-1.39|0.94|||ANCOVA|Based on ANCOVA with terms for sequence, subjects within sequence, period, treatment and baseline.|Mean difference = Empa minus placebo|Non-inferiority margin: 10ms||0.94|-1.39|
70911279|NCT04730947|141312437|SUPERIORITY|||||||0.027|||||||t-test, 2 sided|||||||0.027
70911280|NCT04730947|141312438|SUPERIORITY|||||||0.029|||||||t-test, 2 sided|||||||0.029
70911281|NCT04730947|141312439|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||0.006
70911282|NCT04730947|141312440|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||||||0.12
70911283|NCT04730947|141312441|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
70911284|NCT04730947|141312442|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|||||||0.011
70911285|NCT04730947|141312443|SUPERIORITY|||||||0.088|||||||t-test, 2 sided|||||||0.088
70911286|NCT04730947|141312444|SUPERIORITY|||||||0.024|||||||t-test, 2 sided|||||||0.024
70911287|NCT04730947|141312445|SUPERIORITY|||||||0.136|||||||t-test, 2 sided|||||||0.136
70911288|NCT01450943|141312462|SUPERIORITY||Odds Ratio (OR)|2.712595||||0.0517|TWO_SIDED|95.0|0.9141|8.4839|||Fisher Exact|||||8.4839|0.9141|0.0517
70911289|NCT01450943|141312463|SUPERIORITY||Odds Ratio (OR)|0.812339||||0.7974|TWO_SIDED|95.0|0.2543|2.5224|||Fisher Exact|||||2.5224|0.2543|0.7974
70911290|NCT05153174|141312465|EQUIVALENCE|p \< 0.05 to reject null hypothesis of equivalence||||||0.931|||||||t-test, 2 sided|||||||0.931
70911291|NCT05153174|141312466|EQUIVALENCE|p \< 0.05 to reject null hypothesis of equivalence||||||0.224|||||||t-test, 2 sided|||||||0.224
70911292|NCT05176353|141312488|SUPERIORITY|||||||0.86|||||||Z-score test for person-time rates|||||||0.86
70911293|NCT05176353|141312489|SUPERIORITY|||||||0.05|||||||Z-score test for person-time rates|||||||0.05
70911294|NCT05176353|141312490|SUPERIORITY|||||||0.59|||||||Kruskal-Wallis|||||||0.59
70911295|NCT05176353|141312491|SUPERIORITY||||||<|0.01|||||||Z-score test for person-time rates|||||||<0.01
70911296|NCT05176353|141312492|SUPERIORITY|||||||0.2|||||||Z-score test for person-time rates|||||||0.20
70911297|NCT05176353|141312493|SUPERIORITY|||||||0.03|||||||Z-score test for person-time rates|||||||0.03
70911298|NCT05176353|141312494|SUPERIORITY||||||<|0.01|||||||Z-score test for person-time rates|||||||<0.01
70911299|NCT05176353|141312495|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||.05
70911300|NCT01764386|141312503|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.52|||<|0.0001|TWO_SIDED|95.0|-9.88|-7.15|||ANCOVA|||||-7.15|-9.88|<0.0001
70911301|NCT01764386|141312504|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|44.0|||<|0.0001|TWO_SIDED|95.0|16.6|116.3|||Regression, Logistic|||||116.3|16.6|<0.0001
70911302|NCT01764386|141312505|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.4|||<|0.0001|TWO_SIDED|95.0|6.0|76.7|||Regression, Logistic|||||76.7|6.0|<0.0001
70911303|NCT01764386|141312507|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.65|||<|0.0001|TWO_SIDED|95.0|-10.07|-7.24|||ANCOVA|||||-7.24|-10.07|<0.0001
70911304|NCT01764386|141312508|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.32|||<|0.0001|TWO_SIDED|95.0|-7.14|-3.5|||ANCOVA|||||-3.50|-7.14|<0.0001
70911305|NCT01764386|141312509|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.4||||0.0019|TWO_SIDED|95.0|-29.5|-3.3|||ANCOVA|||||-3.3|-29.5|0.0019
70911306|NCT01764386|141312510|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.9686|TWO_SIDED|95.0|-5.96|5.73|||ANCOVA|||||5.73|-5.96|0.9686
70911307|NCT01764386|141312511|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.0||||0.0001|TWO_SIDED|95.0|1.99|6.06|||ANCOVA|||||6.06|1.99|0.0001
70911308|NCT01764386|141312512|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.1706|TWO_SIDED|95.0|-4.9|0.9|||ANCOVA|||||0.9|-4.9|0.1706
70911309|NCT01764386|141312513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.716|TWO_SIDED|95.0|-2.6|1.8|||ANCOVA|||||1.8|-2.6|0.7160
70911310|NCT01764386|141312514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0||||0.0913|TWO_SIDED|95.0|-0.3|4.3|||ANCOVA|||||4.3|-0.3|0.0913
70911311|NCT01764386|141312515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.5||||0.0016|TWO_SIDED|95.0|-7.2|-1.7|||ANCOVA|||||-1.7|-7.2|0.0016
70911312|NCT01764386|141312516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1||||0.0004|TWO_SIDED|95.0|-6.2|-2.0|||ANCOVA|||||-2.0|-6.2|0.0004
70911313|NCT01764386|141312517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.0003|TWO_SIDED|95.0|-1.7|-0.7|||ANCOVA|||||-0.7|-1.7|0.0003
70911314|NCT01764386|141312518|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.9|||<|0.0001|TWO_SIDED|95.0|-9.8|-6.0|||ANCOVA|||||-6.0|-9.8|<0.0001
70911315|NCT01764386|141312519|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.1|||<|0.0001|TWO_SIDED|95.0|-3.1|-1.1|||ANCOVA|||||-1.1|-3.1|<0.0001
70911316|NCT01764386|141312520|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.4|||<|0.0001|TWO_SIDED|95.0|13.45|21.36|||ANCOVA|||||21.36|13.45|<0.0001
70911317|NCT05349084|141312576|EQUIVALENCE|A Fisher's exact test was performed to determine the association between coronary artery stenosis and PET myocardial blood flow (MBF) values during stress. The following myocardial segments were analyzed: left anterior descending (LAD), left circumflex (LCx), and right coronary artery (RCA). Coronary arteries were categorized as coronary arteries with a diameter stenosis ≥50% or \<50%. The MBF values during stress were categorized as normal or abnormal. Normal MBF is defined as \>1.8 mL/g/min.||||||0.2522||||||The threshold for statistical significance was p = 0.05.|Fisher Exact|||||||0.2522
70911318|NCT05349084|141312577|OTHER|A Pearson's Correlation test was performed between PET MFR during stress and CT-FFR by territory.||||||0.028||||||The threshold for statistical significance was p = 0.05.|Pearson's correlation test|A Pearson's Correlation test was performed between PET MFR during stress and CT-FFR by territory.||||||0.028
70911319|NCT01950260|141312611|SUPERIORITY|||||||0.23|||||||Fisher Exact|||||||0.23
70911320|NCT01950260|141312612|SUPERIORITY|||||||0.41|||||||Regression, Linear|||||||0.41
70911321|NCT01950260|141312613|SUPERIORITY|||||||0.33|||||||Regression, Linear|||||||0.33
70911322|NCT03283553|141312614|SUPERIORITY|||||||0.264||||||P-value represents interaction for differential changes between time point (9 months compared to baseline) and group assignment.|Regression, Logistic|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Complete illness understanding at 9 months was compared to baseline using logistic regression models estimated with generalized estimating equations (GEE) and an exchangeable correlation specification. Each model included group assignment, time (9 months versus baseline), their interaction, and covariates.||||0.264
70911323|NCT03283553|141312615|SUPERIORITY|||||||0.555||||||P-value represents the significance of the term for group assignment.|Regression, Linear|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Satisfaction with cancer care at 9 months was compared to baseline using linear regression models with the difference in the score as the outcome and a term for group assignment as the main independent variable.||||0.555
70911324|NCT03283553|141312616|SUPERIORITY|||||||0.619||||||P-value represents interaction for differential changes between time point (9 months vs baseline) and group assignment.|Regression, Logistic|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Symptoms of anxiety at 9 months were compared to baseline using logistic regression models estimated with generalized estimating equations (GEE) and an exchangeable correlation specification. Each model included group assignment, time (9 months versus baseline), their interaction, and covariates.||||0.619
70911325|NCT03283553|141312617|SUPERIORITY|||||||0.532||||||P-value represents interaction for differential changes between time point (9 months compared to baseline) and group assignment.|Regression, Logistic|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Complete illness understanding at 9 months was compared to baseline using logistic regression models estimated with generalized estimating equations (GEE) and an exchangeable correlation specification. Each model included group assignment, time (9 months versus baseline), their interaction, and covariates.||||0.532
70911326|NCT03283553|141312618|SUPERIORITY|||||||0.108||||||P-value represents the significance of the term for group assignment.|Regression, Linear|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Satisfaction with cancer care at 9 months was compared to baseline using linear regression models with the difference in the score as the outcome and a term for group assignment as the main independent variable.||||0.108
70911327|NCT03283553|141312619|SUPERIORITY|||||||0.405||||||P-value represents interaction for differential changes between time point (9 months vs baseline) and group assignment.|Regression, Logistic|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Symptoms of anxiety at 9 months were compared to baseline using logistic regression models estimated with generalized estimating equations (GEE) and an exchangeable correlation specification. Each model included group assignment, time (9 months versus baseline), their interaction, and covariates.||||0.405
70911328|NCT03283553|141312620|SUPERIORITY|||||||0.412||||||P-value represents the significance of the term for group assignment.|Regression, Linear|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Quality of communication at 9 months was compared to baseline using linear regression models with the difference in the score as the outcome and a term for group assignment as the main independent variable.||||0.412
70911329|NCT03283553|141312621|SUPERIORITY|||||||0.872||||||P-value represents the significance of the term for group assignment.|Regression, Linear|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Quality of communication at 9 months was compared to baseline using linear regression models with the difference in the score as the outcome and a term for group assignment as the main independent variable.||||0.872
70911330|NCT03283553|141312622|SUPERIORITY||||||<|0.001|||||||Fisher Exact|P-value assess between-group differences in proportion of participants who were registered during the 9-month follow up period.||||||<0.001
70911331|NCT03283553|141312623|SUPERIORITY|||||||0.003|||||||Fisher Exact|P-value assess between-group differences in proportion of participants who used a patient portal feature at least once during 9-month follow up.||||||0.003
70911332|NCT03283553|141312624|SUPERIORITY||||||<|0.001|||||||Fisher Exact|P-value assess between-group differences in proportion of participants who used a patient portal feature at least once during 9-month follow up.||||||<0.001
70911333|NCT03283553|141312625|SUPERIORITY|||||||0.128||||||P-value assess between-group differences in proportion of participants who used a patient portal feature at least once during 9-month follow up.|Fisher Exact|||||||0.128
70911334|NCT03283553|141312626|SUPERIORITY|||||||0.247||||||P-value assess between-group differences in proportion of participants who used a patient portal feature at least once during 9-month follow up.|Fisher Exact|||||||0.247
70911335|NCT03686683|141312627|SUPERIORITY||Odds Ratio (OR)|1.16||||0.4586|TWO_SIDED|95.0|0.78|1.74|||Cochran-Mantel-Haenszel|||||1.74|0.78|0.4586
71092399|NCT02832037|141691174|OTHER|Analysis of covariance (ANCOVA) model estimates were used as input for the MCP-Mod. ANCOVA included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.||||||0.0625||||||P-value is considered nominal.|MCP-Mod Sigmoid Emax model fit|Model assumption: 25% of the maximum effect is achieved at 5 mg and 75% of the maximum effect is achieved at 10 mg of BI 425809.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0625
71092400|NCT02832037|141691174|OTHER|Analysis of covariance (ANCOVA) model estimates were used as input for the MCP-Mod. ANCOVA included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.||||||0.0768||||||P-value is considered nominal.|MCP-Mod logistic model fit|Model assumption: 10% of the maximum effect is achieved at 5 mg and 50% of the maximum effect is achieved at 10 mg of BI 425809.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0768
71153666|NCT02093819|141799993|SUPERIORITY_OR_OTHER||Slope|0.9568|STANDARD_ERROR_OF_MEAN|0.1019|||TWO_SIDED|90.0|0.783|1.1307|||||Evaluation of dose proportionality - dose groups 50mg to 600mg. Number of subjects included in the analysis=28.|A power model was used to describe functional relationship between dose and Pk parameters. For the evaluation of dose proportionality,slope parameter (B), a two-sided 90% confidence interval of the slope was calculated. Perfect dose proportionality would correspond to a slope of 1.||1.1307|0.7830|
70911336|NCT00372060|141312632|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.1|<|0.001||95.0|-1.0|-0.6|||ANCOVA|Model terms: treatment, prior oral anti-hyperglycemic medication (except for pioglitazone), and baseline HbA1c.||||-0.6|-1.0|<0.001
70911337|NCT00372060|141312633|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|3.39|<|0.001||95.0|-23.4|-10.0|||ANCOVA|Model terms: treatment, prior oral anti-hyperglycemic medication (except for pioglitazone), and baseline fasting plasma glucose.||||-10.0|-23.4|<0.001
70911338|NCT00372060|141312634|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-49.2|STANDARD_ERROR_OF_MEAN|7.7|<|0.001||95.0|-64.5|-33.9|||ANCOVA|Model terms: treatment, prior oral anti-hyperglycemic medication (except for pioglitazone), and baseline 2-hour postprandial glucose.||||-33.9|-64.5|<0.001
70911339|NCT00647348|141312647|OTHER|intention-to-treat analysis||||||0.003|||||||BBSI=brain boundary shift integral|||||||0.003
70911340|NCT00647348|141312648|SUPERIORITY|||||||0.05||||||EDSS,mean score at 24 months was compared between treatment groups using an ANCOVA model adjusting for baseline score and minimisation variables.|ANCOVA|EDSS,mean score at 24 months was compared between treatment groups using an ANCOVA model adjusting for baseline score and minimisation variables.||||||0.05
70911341|NCT02987829|141312656|OTHER|||||||||||||||||Determination of the maximum tolerated dose.|One dose limiting toxicity occurred at 320 mg daily of grade 3 QTc prolongation therefore the 280 mg dose was determined to be the maximum tolerated dose and selected as the phase 2 dose.|||
70911342|NCT00797225|141312664|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.25||0.0464|TWO_SIDED|95.0|-0.98|-0.01|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.01|-0.98|0.0464
70911343|NCT00797225|141312664|SUPERIORITY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.24||0.008|TWO_SIDED|95.0|-1.13|-0.17|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.17|-1.13|0.0080
70911344|NCT00797225|141312664|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.24||0.0159|TWO_SIDED|95.0|-1.08|-0.11|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.11|-1.08|0.0159
70911345|NCT00797225|141312664|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.29||0.2563|TWO_SIDED|95.0|-0.89|0.24|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.24|-0.89|0.2563
71092401|NCT02832037|141691174|OTHER|Analysis of covariance (ANCOVA) model estimates were used as input for the MCP-Mod. ANCOVA included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.||||||0.7479||||||P-value is considered nominal.|MCP-Mod beta model fit|Assumption:75% of maximum (max) effect at 2mg, 87.5% of max effect at 5mg,25% of max effect at 25mg,max effect at 10mg BI 425809, scalar parameter=26.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.7479
70911346|NCT00797225|141312664|SUPERIORITY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.28||0.0239|TWO_SIDED|95.0|-1.21|-0.09|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.09|-1.21|0.0239
70911347|NCT00797225|141312664|SUPERIORITY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.28||0.028|TWO_SIDED|95.0|-1.19|-0.07|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.07|-1.19|0.0280
70911348|NCT00797225|141312664|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.29||0.6904|TWO_SIDED|95.0|-0.7|0.46|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.46|-0.70|0.6904
70970601|NCT00531752|141447058|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07917|STANDARD_ERROR_OF_MEAN|0.1002||0.4332|TWO_SIDED|80.0|-0.051|0.2093|||Mixed Models Analysis|||Week 3 (RTI): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.20930|-0.0510|0.4332
71092402|NCT02832037|141691174|OTHER||Difference of adjusted means|1.178|STANDARD_ERROR_OF_MEAN|0.7306||0.11|TWO_SIDED|95.0|-0.258|2.613||P-value is considered nominal.|ANCOVA|Analysis of covariance (ANCOVA) model included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||2.613|-0.258|0.11
71092403|NCT02832037|141691174|OTHER||Difference of adjusted means|-0.837|STANDARD_ERROR_OF_MEAN|0.7224||0.25|TWO_SIDED|95.0|-2.257|0.582||P-value is considered nominal.|ANCOVA|Analysis of covariance (ANCOVA) model included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||0.582|-2.257|0.25
70911349|NCT00797225|141312664|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.29||0.4022|TWO_SIDED|95.0|-0.83|0.33|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.33|-0.83|0.4022
70911350|NCT00797225|141312664|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.29||0.0451|TWO_SIDED|95.0|-1.17|-0.01|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.01|-1.17|0.0451
70911351|NCT00797225|141312665|SUPERIORITY||LS Mean Difference|-1.62|STANDARD_ERROR_OF_MEAN|0.48||0.0007|TWO_SIDED|95.0|-2.56|-0.69|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.69|-2.56|0.0007
71092404|NCT02832037|141691174|OTHER||Difference of adjusted means|-0.263|STANDARD_ERROR_OF_MEAN|0.7152||0.71|TWO_SIDED|95.0|-1.669|1.142||P-value is considered nominal.|ANCOVA|Analysis of covariance (ANCOVA) model included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||1.142|-1.669|0.71
70911352|NCT00797225|141312665|SUPERIORITY||LS Mean Difference|-1.63|STANDARD_ERROR_OF_MEAN|0.47||0.0006|TWO_SIDED|95.0|-2.56|-0.7|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.70|-2.56|0.0006
70911353|NCT00797225|141312665|SUPERIORITY||LS Mean Difference|-1.28|STANDARD_ERROR_OF_MEAN|0.47||0.0073|TWO_SIDED|95.0|-2.21|-0.35|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.35|-2.21|0.0073
71092405|NCT02832037|141691174|OTHER||Difference of adjusted means|-1.072|STANDARD_ERROR_OF_MEAN|0.7125||0.13|TWO_SIDED|95.0|-2.473|0.328||P-value is considered nominal.|ANCOVA|Analysis of covariance (ANCOVA) model included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||0.328|-2.473|0.13
71092406|NCT00770367|141691196|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence.|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.37|TWO_SIDED||||||t-test, 2 sided|||A twosample comparison of mean treatment differences conducted using a pre-determined significance level of alpha level \<0.05. 2 a comparison of means for NOx levels at 12 weeks b/w groups. 3 on the change F2-isoprostanes at 12 weeks b/w groups.||||.37
71092407|NCT00435942|141691198|NON_INFERIORITY_OR_EQUIVALENCE|The proportion of subjects in the Effectiveness sample who were free from major device-related AEs at 1-year post-procedure was compared against a performance goal of 0.80 using a 1-sided z-test (normal approximation to the binomial) at an alpha level of 0.025. Rejection of the null hypothesis would provide evidence that this performance goal (proportion-free greater than 0.80) was met.|Proportion free|0.97|||>|0.8|ONE_SIDED|97.5|0.93||||1-sided z-test|97.5% 1-sided confidence interval||The proportion of subjects in the Effectiveness sample who were free from major device-related AEs at 1-year post-procedure was compared against a performance goal of 0.80 using a 1-sided z-test (normal approximation to the binomial) at an alpha level of 0.025. Rejection of the null hypothesis would provide evidence that this performance goal (proportion-free greater than 0.80) was met.|||.93|>0.80
71092408|NCT00920816|141691200|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.767|||||TWO_SIDED|95.0|0.559|1.053||||||First-line participants: hazard ratio was stratified by eastern cooperative oncology group (ECOG) performance status (0 versus 1).||1.053|0.559|
71092409|NCT00920816|141691201|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.731|||||TWO_SIDED|95.0|0.506|1.058||||||Second-line participants: hazard ratio was stratified by eastern cooperative oncology group (ECOG) performance status (0 versus 1) and prior treatment (sunitinib versus cytokine-containing regimen).||1.058|0.506|
71092410|NCT03755076|141691227|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
71092411|NCT03755076|141691228|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
71092412|NCT04167462|141691229|SUPERIORITY||Odds Ratio (OR)|16.49|||<|0.0001|TWO_SIDED|95.0|6.33|42.98|||Cochran-Mantel-Haenszel|||||42.98|6.33|<0.0001
71092413|NCT04167462|141691230|SUPERIORITY||Odds Ratio (OR)|24.29|||<|0.0001|TWO_SIDED|95.0|9.6|61.46|||Cochran-Mantel-Haenszel|||||61.46|9.60|<0.0001
71092414|NCT04167462|141691231|SUPERIORITY||Odds Ratio (OR)|41.19|||<|0.0001|TWO_SIDED|95.0|5.82|291.26|||Cochran-Mantel-Haenszel|||||291.26|5.82|<0.0001
71092415|NCT04167462|141691235|SUPERIORITY||Odds Ratio (OR)|17.27|||<|0.0001|TWO_SIDED|95.0|6.06|49.25|||Cochran-Mantel-Haenszel|||||49.25|6.06|<0.0001
71092416|NCT04167462|141691236|SUPERIORITY||Odds Ratio (OR)|5.1|||<|0.0001|TWO_SIDED|95.0|2.19|11.91|||Cochran-Mantel-Haenszel|||||11.91|2.19|<0.0001
71092417|NCT04167462|141691237|SUPERIORITY||Odds Ratio (OR)|5.86||||0.0947|TWO_SIDED|95.0|0.64|53.28|||Cochran-Mantel-Haenszel|||||53.28|0.64|0.0947
71092418|NCT04167462|141691238|SUPERIORITY||Odds Ratio (OR)|4.11||||0.1741|TWO_SIDED|95.0|0.47|35.74|||Cochran-Mantel-Haenszel|||||35.74|0.47|0.1741
71092419|NCT05383209|141691308|OTHER||Difference in response percentage|-5.0|||||TWO_SIDED|95.0|-24.9|13.4||||||||13.4|-24.9|
71092420|NCT05383209|141691308|OTHER||Slope|-0.2|||||TWO_SIDED|95.0|-20.6|20.6||||||||20.6|-20.6|
71092421|NCT05383209|141691309|OTHER||Difference in response percentage|5.3|||||TWO_SIDED|95.0|-13.2|26.0||||||||26.0|-13.2|
71092422|NCT00149643|141691379|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANOVA|||Groups' categorical baseline measures were compared by chi-square analysis, corrected for continuity. Statistical analyses were completed on an intent to-treat study group basis. Outcome measures for depression and for cannabis use and alcohol use across treatment groups were compared by repeated measures analysis of variance. The last observation carried forward (LOCF)method was used for handling missing data in the data analyses.||||<0.05
71092423|NCT06525727|141691388|OTHER||Sensitivity|97.96|||||TWO_SIDED|95.0|89.15|99.95|||Diagnostic accuracy|Diagnostic performance was analyzed in terms of sensitivity, specificity, NPV, PPV and likelihood ratios, all reported with 95% confidence interval||The primary objective of the study was to assess the external validation of the Falls Decision Rule. In this evaluation, patients were categorized into two groups based on the rule: those for whom a CT scan was recommended and those for whom it was not.||99.95|89.15|
71092424|NCT06525727|141691388|OTHER||Specificity|31.96|||||TWO_SIDED|95.0|28.63|35.42|||Diagnostic accuracy|||||35.42|28.63|
71092425|NCT06525727|141691388|OTHER||Negative predictive value|99.59|||||TWO_SIDED|95.0|97.17|99.94|||Diagnostic accuracy|||||99.94|97.17|
71092426|NCT06525727|141691388|OTHER||Positive predictive value|8.59|||||TWO_SIDED|95.0|8.1|9.1|||Diagnostic accuracy|||||9.1|8.1|
71092427|NCT06525727|141691388|OTHER||Negative likelihood ratio|0.06|||||TWO_SIDED|95.0|0.01|0.42|||Diagnostic accuracy|||||0.42|0.01|
71092428|NCT06525727|141691388|OTHER||Positive likelihood ratio|1.44|||||TWO_SIDED|95.0|1.35|1.53|||Diagnostic accuracy|||||1.53|1.35|
71092429|NCT04666298|141691397|SUPERIORITY||Mean Difference (Net)|-56.6|STANDARD_ERROR_OF_MEAN|3.24|<|0.0001|TWO_SIDED|95.0|-64.2|-49.0||One-sided adjusted p-value for multiple comparisons using Dunnett´s multiple t-test|Mixed Models Analysis|||||-49.0|-64.2|<.0001
71092430|NCT04666298|141691397|SUPERIORITY||Mean Difference (Net)|-60.9|STANDARD_ERROR_OF_MEAN|2.84|<|0.0001|TWO_SIDED|95.0|-67.6|-54.3||One-sided adjusted p-value for multiple comparisons using Dunnett´s multiple t-test|Mixed Models Analysis|||||-54.3|-67.6|<.0001
71092431|NCT04666298|141691397|SUPERIORITY||Mean Difference (Net)|-65.3|STANDARD_ERROR_OF_MEAN|2.86|<|0.0001|TWO_SIDED|95.0|-72.0|-58.6||One-sided adjusted p-value for multiple comparisons using Dunnett´s multiple t-test|Mixed Models Analysis|||||-58.6|-72.0|<.0001
71092432|NCT00844519|141691413|SUPERIORITY_OR_OTHER|||||||0.17||||||significant at p\<0.05|t-test, 2 sided|||within-arm, pre-post change in FMD||||0.17
71092433|NCT00844519|141691413|SUPERIORITY_OR_OTHER|||||||0.9||||||significant at p\<0.05|t-test, 2 sided|||within-arm, pre-post change in FMD||||0.90
71092434|NCT01311661|141691417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.191|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.152|0.229|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.229|0.152|<0.0001
71092435|NCT01311661|141691417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.111|0.189|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.189|0.111|<0.0001
71092436|NCT01311661|141691417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.228|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.19|0.266|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.266|0.190|<0.0001
71092437|NCT01311661|141691417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.17|0.247|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.247|0.170|<0.0001
71092438|NCT01311661|141691418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.15|0.229|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.229|0.150|<0.0001
71092439|NCT01311661|141691418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.121|0.199|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.199|0.121|<0.0001
71092440|NCT01311661|141691418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.214|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.175|0.253|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.253|0.175|<0.0001
71092441|NCT01311661|141691418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.219|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.181|0.258|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.258|0.181|<0.0001
71092442|NCT01311661|141691419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.196|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.153|0.238|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.238|0.153|<0.0001
71092443|NCT01311661|141691419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.102|0.187|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.187|0.102|<0.0001
71092444|NCT01311661|141691419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.242|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.2|0.285|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.285|0.200|<0.0001
71092445|NCT01311661|141691419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.156|0.241|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.241|0.156|<0.0001
71092446|NCT01311661|141691420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.138|0.228|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.228|0.138|<0.0001
70911354|NCT00797225|141312665|SUPERIORITY||LS Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.48||0.0054|TWO_SIDED|95.0|-2.28|-0.4|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.40|-2.28|0.0054
70911355|NCT00797225|141312665|SUPERIORITY||LS Mean Difference|-2.07|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-3.01|-1.12|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-1.12|-3.01|< 0.0001
70911356|NCT00797225|141312665|SUPERIORITY||LS Mean Difference|-2.73|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-3.67|-1.79|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-1.79|-3.67|< 0.0001
70911357|NCT00797225|141312665|SUPERIORITY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.48||0.0509|TWO_SIDED|95.0|-1.89|0.0|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.00|-1.89|0.0509
70911358|NCT00797225|141312665|SUPERIORITY||LS mean Difference|-1.38|STANDARD_ERROR_OF_MEAN|0.48||0.0046|TWO_SIDED|95.0|-2.33|-0.43|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.43|-2.33|0.0046
70911359|NCT00797225|141312665|SUPERIORITY||LS Mean Difference|-2.32|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-3.26|-1.38|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-1.38|-3.26|< 0.0001
70911360|NCT00797225|141312666|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.0453|TWO_SIDED|95.0|-0.33|0.0|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.00|-0.33|0.0453
70911361|NCT00797225|141312666|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.08||0.0609|TWO_SIDED|95.0|-0.31|0.01|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.01|-0.31|0.0609
70911362|NCT00797225|141312666|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.0069|TWO_SIDED|95.0|-0.38|-0.06|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.06|-0.38|0.0069
70911363|NCT00797225|141312666|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.0556|TWO_SIDED|95.0|-0.32|0.0|||Mixed-effects Repeated Measures Model]|||Analysis at Week 8. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.00|-0.32|0.0556
70911364|NCT00797225|141312666|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.08||0.0387|TWO_SIDED|95.0|-0.33|-0.01|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.01|-0.33|0.0387
70911365|NCT00797225|141312666|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.08||0.0008|TWO_SIDED|95.0|-0.44|-0.12|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.12|-0.44|0.0008
70911366|NCT00797225|141312666|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.5879|TWO_SIDED|95.0|-0.21|0.12|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.12|-0.21|0.5879
70911367|NCT00797225|141312666|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.6122|TWO_SIDED|95.0|-0.2|0.12|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.12|-0.20|0.6122
70911368|NCT00797225|141312666|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.08||0.0023|TWO_SIDED|95.0|-0.41|-0.09|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.09|-0.41|0.0023
70911369|NCT00797225|141312667|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.69|-0.24|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.24|-0.69|< 0.0001
70911370|NCT00797225|141312667|SUPERIORITY||LS mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.73|-0.27|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.27|-0.73|< 0.0001
70911371|NCT00797225|141312667|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.71|-0.25|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.25|-0.71|< 0.0001
70911372|NCT00797225|141312667|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.69|-0.23|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.23|-0.69|< 0.0001
70911373|NCT00797225|141312667|SUPERIORITY||LS mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.87|-0.4|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.40|-0.87|< 0.0001
70911374|NCT00797225|141312667|SUPERIORITY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.04|-0.59|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.59|-1.04|< 0.0001
70911375|NCT00797225|141312667|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.12||0.0005|TWO_SIDED|95.0|-0.65|-0.18|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.18|-0.65|0.0005
70911376|NCT00797225|141312667|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.76|-0.29|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.29|-0.76|< 0.0001
70911377|NCT00797225|141312667|SUPERIORITY||LS Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.02|-0.56|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.56|-1.02|< 0.0001
70911378|NCT00797225|141312668|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.1||0.0011|TWO_SIDED|95.0|-0.51|-0.13|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.13|-0.51|0.0011
70911379|NCT00797225|141312668|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.51|-0.13|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.13|-0.51|0.0010
71092447|NCT01311661|141691420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.153|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.108|0.198|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.198|0.108|<0.0001
70911380|NCT00797225|141312668|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.57|-0.19|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.19|-0.57|< 0.0001
70911381|NCT00797225|141312668|SUPERIORITY||-0.33|-0.33|STANDARD_ERROR_OF_MEAN|0.1||0.0007|TWO_SIDED|95.0|-0.52|-0.14|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.14|-0.52|0.0007
70911382|NCT00797225|141312668|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.62|-0.24|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.24|-0.62|< 0.0001
70911383|NCT00797225|141312668|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.73|-0.35|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.35|-0.73|< 0.0001
70911384|NCT00797225|141312668|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.1||0.1319|TWO_SIDED|95.0|-0.34|0.04|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.04|-0.34|0.1319
70911385|NCT00797225|141312668|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.1||0.0222|TWO_SIDED|95.0|-0.42|-0.03|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.03|-0.42|0.0222
70911386|NCT00797225|141312668|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.66|-0.28|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.28|-0.66|< 0.0001
70911387|NCT01363479|141312693|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The null hypothesis was rejected (and non inferiority of oral palonosetron 0.50 mg versus I.V. palonosetron 0.25 mg demonstrated), if the lower limit of the 2 sided 99% CI for the difference in proportion of patients with CR (risk difference) was greater (i.e., closer to zero) than 15%.Study had 90% power.|Risk Difference (RD)|3.21|||||TWO_SIDED|99.0|-2.74|9.17|||||The risk difference and the 99% CI calculation were performed using a 2 sided stratum adjusted Cochran Mantel Haenszel (CMH) test including gender and region as strata.|||9.17|-2.74|
70911388|NCT05489224|141312696|EQUIVALENCE|Predefined margin: -0.6 to 0.5|Treatment difference and 90% CI|-0.1|||||TWO_SIDED|90.0|-0.3|0.1|||ANCOVA|ANCOVA with multiple imputation||||0.10|-0.30|
70911389|NCT04640571|141312700|EQUIVALENCE|Simple one-way t-test to assess if pravastatin AUC value is larger after metformin than after placebo.||||||0.02|||||||t-test, 1 sided|||||||0.02
70911390|NCT04640571|141312701|EQUIVALENCE|Simple one-way t-test to assess if pravastatin Cmax value is larger after metformin than after placebo|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
70911391|NCT04640571|141312702|EQUIVALENCE|Simple one-way t-test to assess if CDCA AUC value is reduced after metformin than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
70911392|NCT04640571|141312703|EQUIVALENCE|Simple one-way t-test to assess if CDCA Cmax value is reduced after metformin than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
70911393|NCT04640571|141312704|EQUIVALENCE|Simple one-way t-test to assess if acyclovir AUC value is reduced after polysorbate 80 than after placebo|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
70911394|NCT04640571|141312705|EQUIVALENCE|Simple one-way t-test to assess if acyclovir Cmax value is reduced after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
70911395|NCT04640571|141312706|EQUIVALENCE|Simple one-way t-test to assess if CDCA AUC value is reduced after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
70911396|NCT04640571|141312707|EQUIVALENCE|Simple one-way t-test to assess if CDCA Cmax value is reduced after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
70911397|NCT04640571|141312708|EQUIVALENCE|Simple one-way t-test to assess if enalaprilat AUC value is increased after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
70970602|NCT00531752|141447058|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2453|STANDARD_ERROR_OF_MEAN|0.1753||0.1678|TWO_SIDED|80.0|-0.473|-0.0177|||Mixed Models Analysis|||Week 3 (More GD than BD): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.0177|-0.4730|0.1678
71092448|NCT01311661|141691420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.222|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.177|0.267|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.267|0.177|<0.0001
70911398|NCT04640571|141312709|EQUIVALENCE|Simple one-way t-test to assess if enalaprilat Cmax value is increased after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
70911399|NCT04640571|141312710|EQUIVALENCE|For each of 15 endogenous bile acid, simple one-way t-test to assess if endogenous bile acid AUC value is larger after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
70911400|NCT04640571|141312711|EQUIVALENCE|For each of 15 endogenous bile acid, simple one-way t-test to assess if endogenous bile acid Cmax value is reduced after metformin than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
70911401|NCT04640571|141312712|EQUIVALENCE|For each of 15 endogenous bile acid, simple one-way t-test to assess if endogenous bile acid AUC value is reduced after metformin than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
70911402|NCT04640571|141312713|EQUIVALENCE|For each of 15 endogenous bile acid, simple one-way t-test to assess if endogenous bile acid Cmax value is larger after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
70911403|NCT04319094|141312742|SUPERIORITY||Mean Difference (Net)|-3.7|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|-4.77|-2.62||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 501|Score difference = Post-intervention - Baseline|Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-2.62|-4.77|<0.0001
70911404|NCT04319094|141312742|SUPERIORITY||Mean Difference (Net)|-2.53|STANDARD_ERROR_OF_MEAN|0.65||0.0001|TWO_SIDED|95.0|-3.81|-1.25||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 501|Score difference = 3-month - Baseline|Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-1.25|-3.81|0.0001
70911405|NCT04319094|141312742|SUPERIORITY||Median Difference (Net)|-2.83|STANDARD_ERROR_OF_MEAN|0.66|<|0.0001|TWO_SIDED|95.0|-4.13|-1.53||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 501|Score difference = 6-month - baseline|Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-1.53|-4.13|<0.0001
71092449|NCT01311661|141691420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.165|0.255|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.255|0.165|<0.0001
70911406|NCT04319094|141312742|SUPERIORITY||Mean Difference (Net)|-2.76|STANDARD_ERROR_OF_MEAN|0.65|<|0.0001|TWO_SIDED|95.0|-4.03|-1.49||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 501|Score difference = 9-month - baseline|Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-1.49|-4.03|<0.0001
70911407|NCT04319094|141312742|SUPERIORITY||Mean Difference (Net)|-2.56|STANDARD_ERROR_OF_MEAN|0.71||0.0003|TWO_SIDED|95.0|-3.95|-1.17||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 501|Score difference =12-month - baseline|Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-1.17|-3.95|0.0003
71092450|NCT01311661|141691421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.109|0.203|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.203|0.109|<0.0001
70911408|NCT04319094|141312742|SUPERIORITY|||||||0.4375|||||||Mixed Models Analysis|||Null hypothesis: There is no difference in the change of PHQ-9 over time between the control and PEERS participants.||||0.4375
71092451|NCT01311661|141691421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.054|0.148|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.148|0.054|<0.0001
71092452|NCT01311661|141691421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.196|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.149|0.243|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.243|0.149|<0.0001
70911409|NCT04319094|141312743|SUPERIORITY||Mean Difference (Net)|1.61|STANDARD_ERROR_OF_MEAN|2.42||0.51|TWO_SIDED|95.0|-3.15|6.37||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 364||Null hypothesis: there is no difference in the mean SF36 - Physical Functioning scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|6.37|-3.15|0.51
70911410|NCT04319094|141312743|SUPERIORITY||Mean Difference (Net)|4.57||||0.18|TWO_SIDED|95.0|-2.08|11.21||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 364||Null hypothesis: there is no difference in the mean SF36-physical function scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|11.21|-2.08|0.18
70911411|NCT04319094|141312743|SUPERIORITY||Mean Difference (Net)|1.57|STANDARD_ERROR_OF_MEAN|3.29||0.63|TWO_SIDED|95.0|-4.89|8.04||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 364||Null hypothesis: there is no difference in the mean SF36-physical function scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|8.04|-4.89|0.63
70911412|NCT04319094|141312743|SUPERIORITY||Mean Difference (Net)|-1.02|STANDARD_ERROR_OF_MEAN|3.01||0.74|TWO_SIDED|95.0|-6.94|4.91||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 364||Null hypothesis: there is no difference in the mean SF36-physical function scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|4.91|-6.94|0.74
70911413|NCT04319094|141312743|SUPERIORITY||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|3.83||0.85|TWO_SIDED|95.0|-6.82|8.23||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 364||Null hypothesis: there is no difference in the mean SF36-physical function scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|8.23|-6.82|0.85
70911414|NCT04319094|141312743|SUPERIORITY|||||||0.3988|||||||Mixed Models Analysis|||Null hypothesis: There is no difference in the change of physical functioning over time between the control and PEERS participants.||||0.3988
70911415|NCT04319094|141312744|SUPERIORITY||Mean Difference (Net)|5.08|STANDARD_ERROR_OF_MEAN|3.41||0.14|TWO_SIDED|95.0|-1.63|11.79||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 360||Null hypothesis: there is no difference in the mean SF36-social function scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|11.79|-1.63|0.14
71092453|NCT01311661|141691421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.125|0.219|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.219|0.125|<0.0001
70970603|NCT00531752|141447058|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07717|STANDARD_ERROR_OF_MEAN|0.1925||0.6901|TWO_SIDED|80.0|-0.1726|0.32695|||Mixed Models Analysis|||Week 3 (More GD than BD): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.32695|-0.1726|0.6901
70970604|NCT00531752|141447058|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1702|STANDARD_ERROR_OF_MEAN|1.354||0.9005|TWO_SIDED|80.0|-1.587|1.9274|||Mixed Models Analysis|||Week 3 (Living with ADHD): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.9274|-1.587|0.9005
71092454|NCT01311661|141691422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.091|0.18|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.180|0.091|<0.0001
71092455|NCT01311661|141691422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.122|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.078|0.167|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.167|0.078|<0.0001
70911416|NCT04319094|141312744|SUPERIORITY||Mean Difference (Net)|10.32|STANDARD_ERROR_OF_MEAN|4.0||0.01|TWO_SIDED|95.0|2.45|18.19||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 360||Null hypothesis: there is no difference in the mean SF36-social function scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|18.19|2.45|0.01
70911417|NCT04319094|141312744|SUPERIORITY||Mean Difference (Net)|10.25|STANDARD_ERROR_OF_MEAN|4.19||0.015|TWO_SIDED|95.0|2.01|18.5||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 360||Null hypothesis: there is no difference in the mean SF36-social function scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|18.5|2.01|0.015
70911418|NCT04319094|141312744|SUPERIORITY||Mean Difference (Net)|11.72|STANDARD_ERROR_OF_MEAN|4.07||0.004|TWO_SIDED|95.0|3.7|19.73||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|degrees of freedom: 360||Null hypothesis: there is no difference in the mean SF36-social function scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|19.73|3.7|0.004
70911419|NCT04319094|141312744|SUPERIORITY||Mean Difference (Net)|5.73|STANDARD_ERROR_OF_MEAN|4.49||0.2|TWO_SIDED|95.0|-3.09|14.55||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 360||Null hypothesis: there is no difference in the mean SF36-social function scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|14.55|-3.09|0.2
70911420|NCT04319094|141312744|SUPERIORITY|||||||0.8037|||||||Mixed Models Analysis|||Null hypothesis: There is no difference in the change of social functioning over time between the control and PEERS participants.||||0.8037
70911421|NCT04319094|141312745|SUPERIORITY||Median Difference (Net)|12.52|STANDARD_ERROR_OF_MEAN|5.01||0.0129|TWO_SIDED|95.0|2.67|22.37||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 366||Null hypothesis: there is no difference in the mean SF36-emotional functioning scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|22.37|2.67|0.0129
70911422|NCT04319094|141312745|SUPERIORITY||Mean Difference (Net)|19.84|STANDARD_ERROR_OF_MEAN|5.86||0.0008|TWO_SIDED|95.0|8.32|31.36||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 366||Null hypothesis: there is no difference in the mean SF36-emotional functioning scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|31.36|8.32|0.0008
71092456|NCT01311661|141691422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.098|0.186|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.186|0.098|<0.0001
71092457|NCT01311661|141691422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.103|0.191|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.191|0.103|<0.0001
71092458|NCT01311661|141691423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.11|0.206|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.206|0.110|<0.0001
71092459|NCT01311661|141691423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.09|0.185|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.185|0.090|<0.0001
71092460|NCT01311661|141691423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.123|0.218|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.218|0.123|<0.0001
70911423|NCT04319094|141312745|SUPERIORITY||Median Difference (Net)|17.99|STANDARD_ERROR_OF_MEAN|6.14||0.0036|TWO_SIDED|95.0|5.92|30.06||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 366||Null hypothesis: there is no difference in the mean SF36-emotional functioning scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|30.06|5.92|0.0036
70911424|NCT04319094|141312745|SUPERIORITY||Median Difference (Net)|16.24|STANDARD_ERROR_OF_MEAN|5.98||0.007|TWO_SIDED|95.0|4.47|28.01||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 366||Null hypothesis: there is no difference in the mean SF36-emotional functioning scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|28.01|4.47|0.007
70911425|NCT04319094|141312745|SUPERIORITY||Mean Difference (Net)|12.26|STANDARD_ERROR_OF_MEAN|6.58||0.065|TWO_SIDED|95.0|-0.68|25.19||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 366||Null hypothesis: there is no difference in the mean SF36-emotional functioning scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|25.19|-0.68|0.065
70911426|NCT04319094|141312745|SUPERIORITY|||||||0.881|||||||Mixed Models Analysis|||Null hypothesis: There is no difference in the change of emotional functioning over time between the control and PEERS participants.||||0.8810
70911427|NCT04319094|141312746|SUPERIORITY|||||||0.031||||||The a priori threshold for statistical significance is p=0.05.|F-test for overall significance|Degrees of freedom: 370||Null hypothesis: there is no difference in the change in probability of ER use from baseline to post-intervention between PEERS and control participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|||0.031
70911428|NCT04319094|141312751|SUPERIORITY||Mean Difference (Net)|-4.98|STANDARD_ERROR_OF_MEAN|1.42||0.0005|TWO_SIDED|95.0|-7.78|-2.18||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 414|Score difference: post-intervention - baseline|Null hypothesis: there is no difference in the mean UCLA Loneliness scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-2.18|-7.78|0.0005
70911429|NCT04319094|141312751|SUPERIORITY||Mean Difference (Net)|-7.38|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|-11.08|-3.69||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 414|Score difference: 3-month - baseline|Null hypothesis: there is no difference in the mean UCLA Loneliness scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-3.69|-11.08|<0.0001
70970605|NCT00531752|141447058|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4317|STANDARD_ERROR_OF_MEAN|1.4667||0.333|TWO_SIDED|80.0|-3.333|0.46937|||Mixed Models Analysis|||Week 3 (Living with ADHD): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.46937|-3.333|0.3330
71092461|NCT01311661|141691423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.087|0.182|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.182|0.087|<0.0001
71092462|NCT01311661|141691424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.102|0.188|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.188|0.102|<0.0001
71092463|NCT01311661|141691424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.085|0.171|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.171|0.085|<0.0001
71092464|NCT01311661|141691424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.113|0.198|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.198|0.113|<0.0001
70911430|NCT04319094|141312751|SUPERIORITY||Mean Difference (Net)|-7.63|STANDARD_ERROR_OF_MEAN|1.87|<|0.0001|TWO_SIDED|95.0|-11.3|-3.95||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 414|Score difference: 6-month - baseline|Null hypothesis: there is no difference in the mean UCLA Loneliness scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-3.95|-11.3|<0.0001
70911431|NCT04319094|141312751|SUPERIORITY||Mean Difference (Net)|-8.12|STANDARD_ERROR_OF_MEAN|1.74|<|0.0001|TWO_SIDED|95.0|-11.53|-4.7||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 414|Score difference: 9-month - baseline|Null hypothesis: there is no difference in the mean UCLA Loneliness scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-4.7|-11.53|<0.0001
70911432|NCT04319094|141312751|SUPERIORITY||Mean Difference (Net)|-8.26|STANDARD_ERROR_OF_MEAN|2.09|<|0.0001|TWO_SIDED|95.0|-12.37|-4.14||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 414|Score difference: 12-month - baseline|Null hypothesis: there is no difference in the mean UCLA Loneliness scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-4.14|-12.37|<0.0001
70911433|NCT04319094|141312751|SUPERIORITY|||||||0.6857|||||||Mixed Models Analysis|||Null hypothesis: there is no statistical difference in the change of UCLA Loneliness score over time between control and PEERS participants||||0.6857
70911434|NCT04319094|141312752|SUPERIORITY||Mean Difference (Net)|1.79|STANDARD_ERROR_OF_MEAN|0.54||0.001|TWO_SIDED|95.0|0.72|2.86|||Mixed Models Analysis|Degrees of freedom: 421|Score difference: post-intervention - baseline|Null hypothesis: there is no difference in the mean GSES scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|2.86|0.72|0.001
70911435|NCT04319094|141312752|SUPERIORITY||Mean Difference (Net)|0.93|STANDARD_ERROR_OF_MEAN|0.67||0.18|TWO_SIDED|95.0|-0.39|2.25||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 421|Score difference: 3-month - baseline|Null hypothesis: there is no difference in the mean GSES scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|2.25|-0.39|0.18
70911436|NCT04319094|141312752|SUPERIORITY||Mean Difference (Net)|1.11|STANDARD_ERROR_OF_MEAN|0.68||0.11|TWO_SIDED|95.0|-0.24|2.45||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 421|Score difference: 6-month - baseline|Null hypothesis: there is no difference in the mean GSES scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|2.45|-0.24|0.11
70970606|NCT00531752|141447058|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6537|STANDARD_ERROR_OF_MEAN|2.0857||0.7551|TWO_SIDED|80.0|-2.051|3.3584|||Mixed Models Analysis|||Week 3 (General well-being): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.3584|-2.051|0.7551
71092465|NCT01311661|141691424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.098|0.182|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.182|0.098|<0.0001
71092466|NCT01311661|141691425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.084|0.187|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.187|0.084|<0.0001
71092467|NCT01311661|141691425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.124|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.073|0.176|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.176|0.073|<0.0001
71092468|NCT01311661|141691425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.093|0.195|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.195|0.093|<0.0001
70911437|NCT04319094|141312752|SUPERIORITY||Mean Difference (Net)|2.26|STANDARD_ERROR_OF_MEAN|0.65||0.0006|TWO_SIDED|95.0|0.98|3.54||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 421|Score difference: 9-month - baseline|Null hypothesis: there is no difference in the mean GSES scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|3.54|0.98|0.0006
70911438|NCT04319094|141312752|SUPERIORITY||Mean Difference (Net)|2.48|STANDARD_ERROR_OF_MEAN|0.75||0.001|TWO_SIDED|95.0|1.01|3.95||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 421|Score difference: 12-month - baseline|Null hypothesis: there is no difference in the mean GSES scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|3.95|1.01|0.001
70911439|NCT04319094|141312752|SUPERIORITY|||||||0.1195|||||||Mixed Models Analysis|||Null hypothesis: There is no difference in the change of GSES scores over time between the control and PEERS participants.||||0.1195
70911440|NCT04319094|141312753|SUPERIORITY||Mean Difference (Net)|3.22|STANDARD_ERROR_OF_MEAN|0.77|<|0.0001|TWO_SIDED|95.0|1.71|4.73||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 361|Score difference: post-intervention - baseline|Null hypothesis: there is no difference in the mean Brief-COPE Adaptive Coping scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|4.73|1.71|<0.0001
70911441|NCT04319094|141312753|SUPERIORITY||Mean Difference (Net)|2.59|STANDARD_ERROR_OF_MEAN|1.03||0.0123|TWO_SIDED|95.0|0.57|4.62||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 361|Score difference: 3-month - baseline|Null hypothesis: there is no difference in the mean Brief-COPE Adaptive Coping scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|4.62|0.57|0.0123
70911442|NCT04319094|141312753|SUPERIORITY||Mean Difference (Net)|2.63|STANDARD_ERROR_OF_MEAN|1.02||0.01|TWO_SIDED|95.0|0.63|4.63||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 361|Score difference: 6-month - baseline|Null hypothesis: there is no difference in the mean Brief-COPE Adaptive Coping scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|4.63|0.63|0.01
70911443|NCT04319094|141312753|SUPERIORITY||Mean Difference (Net)|4.18|STANDARD_ERROR_OF_MEAN|0.95|<|0.0001|TWO_SIDED|95.0|2.32|6.04||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 361|Score difference: 9-month - baseline|Null hypothesis: there is no difference in the mean Brief-COPE Adaptive Coping scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|6.04|2.32|<0.0001
70911444|NCT04319094|141312753|SUPERIORITY||Mean Difference (Net)|3.14|STANDARD_ERROR_OF_MEAN|1.17||0.0078|TWO_SIDED|95.0|0.83|5.44||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 361|Score difference: 12-month - baseline|Null hypothesis: there is no difference in the mean Brief-COPE Adaptive Coping scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|5.44|0.83|0.0078
70911445|NCT04319094|141312753|SUPERIORITY|||||||0.1408|||||||Mixed Models Analysis|||Null hypothesis: there is no statistical difference in the change in adaptive coping over time between control and PEERS participants.||||0.1408
71092469|NCT01311661|141691425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.075|0.177|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.177|0.075|<0.0001
71092470|NCT01311661|141691426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.028||0.0001||95.0|0.055|0.165|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.165|0.055|0.0001
71092471|NCT01311661|141691426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.028||0.001||95.0|0.037|0.147|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.147|0.037|0.0010
71092472|NCT01311661|141691426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.063|0.172|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.172|0.063|<0.0001
71092473|NCT01311661|141691426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.057|0.166|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.166|0.057|<0.0001
71092474|NCT01311661|141691427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.629|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001||95.0|0.5|0.757|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.757|0.500|<0.0001
71092475|NCT01311661|141691427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.601|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001||95.0|0.473|0.73|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.730|0.473|<0.0001
71092476|NCT01311661|141691427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.631|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001||95.0|0.503|0.758|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.758|0.503|<0.0001
71092477|NCT01311661|141691427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.685|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001||95.0|0.558|0.813|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.813|0.558|<0.0001
71092478|NCT01311661|141691428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.665|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.532|0.799|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.799|0.532|<0.0001
71092479|NCT01311661|141691428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.564|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.431|0.698|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.698|0.431|<0.0001
71092480|NCT01311661|141691428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.702|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.569|0.835|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.835|0.569|<0.0001
71092481|NCT01311661|141691428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.599|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001||95.0|0.467|0.732|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.732|0.467|<0.0001
71092482|NCT01311661|141691429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.641|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.516|0.765|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.765|0.516|<0.0001
71092483|NCT01311661|141691429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.577|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.453|0.701|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.701|0.453|<0.0001
71092484|NCT01311661|141691429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.667|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.544|0.79|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.790|0.544|<0.0001
71092485|NCT01311661|141691429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.643|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.519|0.766|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.766|0.519|<0.0001
71092486|NCT01311661|141691430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.591|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001||95.0|0.436|0.746|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.746|0.436|<0.0001
71092487|NCT01311661|141691430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.522|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001||95.0|0.366|0.677|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.677|0.366|<0.0001
71092488|NCT01311661|141691430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.594|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001||95.0|0.439|0.749|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.749|0.439|<0.0001
71092489|NCT01311661|141691430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.623|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001||95.0|0.468|0.777|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.777|0.468|<0.0001
71092490|NCT01311661|141691431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.529|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.396|0.662|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.662|0.396|<0.0001
70911446|NCT04956692|141312754|NON_INFERIORITY|The non-inferiority margin with respect to the geometric means ratio (GMR) was 0.8|Geometric Mean Ratio (GMR)|1.04|||<|0.0001|TWO_SIDED|96.0|0.98|1.1||The one-sided p-value non-inferiority boundary is 0.02|t-test, 1 sided|Welch's unequal variances t-test. The null hypothesis was that GMR≤0.8.|Numerator Arm A/Denominator Arm B|||1.10|0.98|<0.0001
70911447|NCT04956692|141312755|NON_INFERIORITY|The non-inferiority margin with respect to the geometric means ratio (GMR) was 0.8|Geometric Mean Ratio (GMR)|1.85|||<|0.0001|TWO_SIDED|94.0|1.69|2.03||The one-sided p-value non-inferiority boundary is 0.03|t-test, 1 sided|Welch's unequal variances t-test. The null hypothesis was that GMR≤0.8.|Numerator Arm A/Denominator Arm B|||2.03|1.69|<0.0001
70911448|NCT01016353|141312770|SUPERIORITY|||||||0.06|||||||Log Rank|||||||0.06
70911449|NCT05780047|141312771|OTHER||||||<|0.05|||||||t-test, 1 sided|||||||<0.05
70911450|NCT05780047|141312772|OTHER||||||<|0.05|||||||paired samples t-test|||Paired samples t-tests were run to compare whether EHL knowledge, attitudes and behavior changed after the intervention. EHL scores were expected to increase between pre and post testing.||||<0.05
70911451|NCT04873817|141312773|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||< 0.0001
70911452|NCT00665561|141312775|SUPERIORITY||Risk Ratio (RR)|0.53|||||TWO_SIDED|95.0|0.42|0.67||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude risk ratio (RR) and CI.||0.67|0.42|
70911453|NCT00665561|141312776|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.12|5.88||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||5.88|0.12|
70911454|NCT00665561|141312777|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.66|1.33||||||All Malignancies: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||1.33|0.66|
70911455|NCT00665561|141312777|SUPERIORITY||Risk Ratio (RR)|0.62|||||TWO_SIDED|95.0|0.29|1.31||||||AIDS defining Malignancies: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||1.31|0.29|
70911456|NCT00665561|141312777|SUPERIORITY||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.71|1.58||||||Non-AIDS defining Malignancies: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||1.58|0.71|
70911457|NCT00665561|141312778|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.44|2.18||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||2.18|0.44|
70911458|NCT00665561|141312779|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.51|1.59||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||1.59|0.51|
70911459|NCT00665561|141312780|SUPERIORITY||Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.7|1.76||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||1.76|0.70|
70911460|NCT00665561|141312781|SUPERIORITY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.25|4.93||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||4.93|0.25|
70911461|NCT00665561|141312782|SUPERIORITY||Risk Ratio (RR)|0.66|||||TWO_SIDED|95.0|0.18|2.47||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||2.47|0.18|
70911462|NCT00665561|141312783|SUPERIORITY||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.57|1.08||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||1.08|0.57|
70911463|NCT00665561|141312784|SUPERIORITY||Risk Ratio (RR)|0.78|||||TWO_SIDED|95.0|0.61|0.99||||||Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||0.99|0.61|
70911464|NCT00665561|141312785|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.64|1.33||||||All malignancies: Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||1.33|0.64|
70911465|NCT00665561|141312785|SUPERIORITY||Risk Ratio (RR)|0.7|||||TWO_SIDED|95.0|0.32|1.52||||||AIDS defining malignancies: Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||1.52|0.32|
70911466|NCT00665561|141312785|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.66|1.52||||||Non-AIDS defining malignancies: Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||1.52|0.66|
70911467|NCT00665561|141312786|SUPERIORITY||Risk Ratio (RR)|0.62|||||TWO_SIDED|95.0|0.35|1.1||||||Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||1.10|0.35|
70911468|NCT00665561|141312787|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.59|1.52||||||Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||1.52|0.59|
70911469|NCT00665561|141312788|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.66|1.28||||||Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||1.28|0.66|
70911470|NCT00665561|141312789|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.6225|TWO_SIDED|95.0|0.66|1.28|||Regression, Cox|||||1.28|0.66|0.6225
70911471|NCT02081365|141312790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2|||<|0.05|TWO_SIDED|95.0|0.74|3.55|||ANCOVA|||Comparison of two groups at 1 month follow up with baseline value as the covariate||3.55|.74|<0.05
70911472|NCT02081365|141312791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.98|||<|0.05|TWO_SIDED|95.0|0.39|1.57|||ANCOVA|||Comparison of two groups at 1 month follow up with baseline value as the covariate||1.57|.39|<0.05
70911473|NCT02081365|141312792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.23|||<|0.05|TWO_SIDED|95.0|0.61|1.85|||ANCOVA|||Comparison of two groups at 1 month follow up with baseline value as the covariate||1.85|.61|<0.05
70911474|NCT02081365|141312793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|||<|0.05|TWO_SIDED|95.0|0.01|1.64|||ANCOVA|||Comparison of two groups at 1 month follow up with baseline value as the covariate||1.64|.01|<0.05
70911475|NCT03230006|141312810|SUPERIORITY||Partial eta squared|0.152||||0.002|TWO_SIDED|95.0|||||ANOVA||A two-way mixed ANOVA was conducted to investigate treatment group differences in change in mean number of drinks consumed from baseline to post-treatment, as indicated by the Time by Treatment Condition interaction effect.|||||0.002
70911476|NCT03230006|141312810|SUPERIORITY||Partial eta squared|0.342|||<|0.001|TWO_SIDED|95.0||||The threshold for significance is p \<.05.|ANOVA||This is the partial eta squared for the main effect of time.|||||<.001
70911477|NCT03230006|141312810|SUPERIORITY||Partial eta squared|0.018||||0.309|TWO_SIDED|95.0|||||ANOVA||This is the partial eta squared for the main effect of treatment condition.|||||.309
70911478|NCT03230006|141312810|OTHER||F|38.92|||<|0.001|TWO_SIDED|95.0||||The threshold for significance is p \<.05.|ANOVA|||After conducting the initial two-way mixed ANOVA, follow-up testing was conducted to determine the simple main effects of time (pre to post) on mean number of drinks per week within each treatment condition, which was examined using one-way repeated measures ANOVAs.||||<.001
70911479|NCT03230006|141312810|OTHER||F|5.43||||0.03|TWO_SIDED|95.0|||||ANOVA|||After conducting the initial two-way mixed ANOVA, follow-up testing was conducted to determine the simple main effects of time (pre to post) on mean number of drinks per week within each treatment condition, which was examined using one-way repeated measures ANOVAs.||||.030
70911480|NCT03230006|141312810|OTHER||F|1.15||||0.016|TWO_SIDED|95.0|||||ANOVA||This is the simple main effect of treatment condition on mean number of drinks consumed per week at baseline. For the UP, n=51; for the TC, n=24.|After conducting the initial two-way mixed ANOVA, the simple main effects for treatment condition on mean number of drinks consumed per week at each timepoint (pre and post) were examined using one-way ANOVAs.||||.016
70911481|NCT03230006|141312810|OTHER||F|7.78||||0.007|TWO_SIDED|95.0|||||ANOVA||This is the simple main effect of treatment condition on mean number of drinks consumed per week at post-treatment. For the UP, n=38; for the TC, n=21.|After conducting the initial two-way mixed ANOVA, the simple main effects for treatment condition on mean number of drinks consumed per week at each timepoint (pre and post) were examined using one-way ANOVAs.||||.007
71092491|NCT01311661|141691431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.277|0.543|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.543|0.277|<0.0001
71092492|NCT01311661|141691431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.603|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001||95.0|0.471|0.736|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.736|0.471|<0.0001
70911482|NCT01866917|141312818|SUPERIORITY|||||||0.574|||||||Chi-squared|||||||.574
70911483|NCT01866917|141312819|SUPERIORITY|Statistical analysis performed using SPSS software, version 15 (SPSS Inc., Chicago, IL). Data for quantitative variables reported as a median and interquartile range. The Mann Whitney and chi-square tests were used for the analysis of continuous and categorical variables.|Interquartile range (IQR)|3.0||||0.825|TWO_SIDED|||||Effect size was calculated for the numeric pain rating scale at the immediate post-operative period, 4-hour, 8-hour , 12-hour, and 24-hour time periods as a means to assess post-operative pain control.|Chi-squared|||TAP has been demonstrated to have a potential role in reducing pain, post-operative opioid requirement, and time to hospital discharge after abdominal hysterectomies and cesarean sections.||||.825
70911484|NCT01449929|141312825|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTG 50 mg and DRV+RTV at Week 48 can be concluded if the lower bound of a two-sided 95% confidence interval (CI) for the difference in percentages (DTG - DRV+RTV) is greater than -12%. If non-inferiority is established, superiority can be tested at the nominal 5% level based on a pre-specified testing procedure.|Difference in percentage|7.1||||0.025|TWO_SIDED|95.0|0.9|13.2||P-value is for test of superiority.|Cochran-Mantel-Haenszel|Stratified analysis|Analysis was adjusted for the Baseline (BL) stratification factors: Baseline plasma HIV-1 RNA (\<=100,000 c/mL vs \>100,000 c/mL) and Baseline background dual NRTI therapy (ABC/3TC vs TDF/FTC).|||13.2|0.9|0.025
70911485|NCT01871285|141312844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.182||||0.7942|TWO_SIDED|95.0|-1.6|1.24|||Mixed Models Analysis|||||1.24|-1.60|.7942
70911486|NCT01871285|141312844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.683||||0.6155|TWO_SIDED|95.0|-11.89|13.25|||Mixed Models Analysis|||||13.25|-11.89|.6155
71092493|NCT01311661|141691431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.481|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001||95.0|0.349|0.613|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.613|0.349|<0.0001
71092494|NCT01311661|141691432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.957|STANDARD_ERROR_OF_MEAN|3.18|<|0.0001||95.0|26.709|39.206|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||39.206|26.709|<0.0001
71092495|NCT01311661|141691432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.632|STANDARD_ERROR_OF_MEAN|3.167|<|0.0001||95.0|26.409|38.855|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||38.855|26.409|<0.0001
70911487|NCT01871285|141312845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.182||||0.7942|TWO_SIDED|95.0|-1.6|1.24|||Mixed Models Analysis|||||1.24|-1.60|.7942
71092496|NCT01311661|141691432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.66|STANDARD_ERROR_OF_MEAN|3.161|<|0.0001||95.0|25.448|37.872|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||37.872|25.448|<0.0001
71092497|NCT01311661|141691432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.895|STANDARD_ERROR_OF_MEAN|3.161|<|0.0001||95.0|22.683|35.107|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||35.107|22.683|<0.0001
70911488|NCT01871285|141312845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.683||||0.6155|TWO_SIDED|95.0|-11.89|13.25|||Mixed Models Analysis|||||13.25|-11.89|.6155
70911489|NCT01955382|141312853|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
70911490|NCT01251614|141312900|SUPERIORITY_OR_OTHER||Difference|-25.5||||0.027|TWO_SIDED|95.0|-47.2|-3.7|||Chi-squared|||"The a priori defined order of the statistical hypotheses was as follows:~1. Superiority of adalimumab 0.8 mg/kg versus MTX for the percentage of participants achieving a ≥ PASI 75 response at Week 16.~2. Superiority of adalimumab 0.8 mg/kg versus MTX, for the percentage of participants achieving a PGA cleared or minimal at Week 16.~This order was adhered to for confirmatory testing, all statistical tests were at a level of significance of 5% and the overall type I error was preserved."||-3.7|-47.2|0.027
70911491|NCT01251614|141312901|SUPERIORITY_OR_OTHER||Difference|-20.0||||0.083|TWO_SIDED|95.0|-42.2|2.2|||Chi-squared|||"The a priori defined order of the statistical hypotheses was as follows:~1. Superiority of adalimumab 0.8 mg/kg versus MTX for the percentage of participants achieving a ≥ PASI 75 response at Week 16.~2. Superiority of adalimumab 0.8 mg/kg versus MTX, for the percentage of participants achieving a PGA cleared or minimal at Week 16.~This order was adhered to for confirmatory testing, all statistical tests were at a level of significance of 5% and the overall type I error was preserved."||2.2|-42.2|0.083
70911492|NCT01251614|141312902|SUPERIORITY_OR_OTHER||Difference|-7.3||||0.466|TWO_SIDED|95.0|-26.9|12.3|||Chi-squared|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (p-value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.||12.3|-26.9|0.466
70911493|NCT01251614|141312903|SUPERIORITY_OR_OTHER||Difference|-15.7||||0.056|TWO_SIDED|95.0|-29.1|-2.3|||Fisher Exact|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (p-value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.||-2.3|-29.1|0.056
70911494|NCT01251614|141312904|SUPERIORITY_OR_OTHER||Difference|1.61||||0.304|TWO_SIDED|95.0|-1.48|4.7|||ANOVA|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (p-value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.||4.70|-1.48|0.304
70911495|NCT01251614|141312905|SUPERIORITY_OR_OTHER||Difference|-8.88||||0.005|TWO_SIDED|95.0|-14.94|-2.82|||ANOVA|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (p-value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.||-2.82|-14.94|0.005
70911496|NCT01251614|141312906|SUPERIORITY_OR_OTHER||Difference|-28.3||||0.113|TWO_SIDED|95.0|-60.6|4.0|||Chi-squared|||"The difference between the combined adalimumab 0.8 mg/kg + MTX groups versus the adalimumab 0.4 mg/kg group.~Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were to be 2-sided with the significance level of 5%. Statistically significant results (P value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank."||4.0|-60.6|0.113
70911497|NCT01251614|141312907|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||0.343|TWO_SIDED|95.0|0.66|3.17|||Log Rank|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (P value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.||3.17|0.66|0.343
70911498|NCT01251614|141312907|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51||||0.276|TWO_SIDED|95.0|0.71|3.21|||Log Rank|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (P value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.||3.21|0.71|0.276
70911499|NCT00886613|141312945|SUPERIORITY_OR_OTHER||kappa coefficient of agreement|0.85||||0.564|TWO_SIDED|90.0|0.72|0.99|||McNemar||The significance of the difference between the proportion of subjects with a positive skin test at 48 hours and the proportion of subjects with a positive skin test at 72 hours|||0.99|0.72|0.564
70911500|NCT00886613|141312947|SUPERIORITY_OR_OTHER||Difference in proportions|0.06||||0.343|TWO_SIDED|90.0|-0.17|0.28|||Chi-squared||Statistical analysis for dose 2|||0.28|-0.17|0.343
70911501|NCT01996644|141312950|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED||||||ANOVA|||||||.043
71092498|NCT01311661|141691433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.87|STANDARD_ERROR_OF_MEAN|3.046|<|0.0001||95.0|22.884|34.856|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||34.856|22.884|<0.0001
70911502|NCT03566680|141312970|EQUIVALENCE||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70911503|NCT03566680|141312971|EQUIVALENCE||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70911504|NCT03566680|141312972|EQUIVALENCE||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70911505|NCT03566680|141312973|EQUIVALENCE|||||||0.73|||||||t-test, 2 sided|||||||0.73
70911506|NCT03566680|141312974|EQUIVALENCE|||||||0.08|||||||t-test, 2 sided|||||||0.08
70911507|NCT03566680|141312975|EQUIVALENCE|||||||0.72|||||||t-test, 2 sided|||||||0.72
70911508|NCT01492309|141312987|SUPERIORITY|||||||0.003|||||||Fisher Exact|||This analysis is based on a mixed model that can handle missing data.||||0.003
70911509|NCT01492309|141312988|SUPERIORITY|||||||0.425|||||||Regression, Logistic|||This analysis is based on a mixed model that can handle missing data.||||0.425
70911510|NCT02374957|141312991|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|||"Null hypothesis: six-week change in EQ5D sum score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EQ5D than the other over initial six weeks (two-sided test)."||||0.26
71092499|NCT01311661|141691433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.056|STANDARD_ERROR_OF_MEAN|3.034|<|0.0001||95.0|26.094|38.018|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||38.018|26.094|<0.0001
71092500|NCT01311661|141691433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.816|STANDARD_ERROR_OF_MEAN|3.028|<|0.0001||95.0|25.864|37.767|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||37.767|25.864|<0.0001
71092501|NCT01311661|141691433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.327|STANDARD_ERROR_OF_MEAN|3.028|<|0.0001||95.0|27.375|39.278|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||39.278|27.375|<0.0001
71092502|NCT01311661|141691434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.581|STANDARD_ERROR_OF_MEAN|0.346|<|0.0001||95.0|-2.262|-0.9|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||-0.900|-2.262|<0.0001
71092503|NCT01311661|141691434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.426|STANDARD_ERROR_OF_MEAN|0.345|<|0.0001||95.0|-2.104|-0.748|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||-0.748|-2.104|<0.0001
71092504|NCT01311661|141691434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.738|STANDARD_ERROR_OF_MEAN|0.344|<|0.0001||95.0|-2.415|-1.062|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||-1.062|-2.415|<0.0001
71092505|NCT01311661|141691434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.689|STANDARD_ERROR_OF_MEAN|0.344||0.0458||95.0|-1.366|-0.013|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||-0.013|-1.366|0.0458
71092506|NCT01311661|141691435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|173.391|STANDARD_ERROR_OF_MEAN|19.484|<|0.0001||95.0|135.099|211.682|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||211.682|135.099|<0.0001
71092507|NCT01311661|141691435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|155.097|STANDARD_ERROR_OF_MEAN|19.406|<|0.0001||95.0|116.961|193.234|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||193.234|116.961|<0.0001
71092508|NCT01311661|141691435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|149.268|STANDARD_ERROR_OF_MEAN|19.369|<|0.0001||95.0|111.204|187.333|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||187.333|111.204|<0.0001
71092509|NCT01311661|141691435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|150.441|STANDARD_ERROR_OF_MEAN|19.369|<|0.0001||95.0|112.377|188.505|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||188.505|112.377|<0.0001
71092510|NCT01311661|141691436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|142.251|STANDARD_ERROR_OF_MEAN|18.997|<|0.0001||95.0|104.916|179.586|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||179.586|104.916|<0.0001
71092511|NCT01311661|141691436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|132.138|STANDARD_ERROR_OF_MEAN|18.92|<|0.0001||95.0|94.954|169.322|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||169.322|94.954|<0.0001
71092512|NCT01311661|141691436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|142.136|STANDARD_ERROR_OF_MEAN|18.885|<|0.0001||95.0|105.021|179.251|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||179.251|105.021|<0.0001
71092513|NCT01311661|141691436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|157.306|STANDARD_ERROR_OF_MEAN|18.885|<|0.0001||95.0|120.192|194.42|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||194.420|120.192|<0.0001
71092514|NCT01311661|141691437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.554|STANDARD_ERROR_OF_MEAN|0.115|<|0.0001||95.0|-0.78|-0.329|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||-0.329|-0.780|<0.0001
71092515|NCT01311661|141691437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.637|STANDARD_ERROR_OF_MEAN|0.114|<|0.0001||95.0|-0.862|-0.412|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||-0.412|-0.862|<0.0001
71092516|NCT01311661|141691437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.588|STANDARD_ERROR_OF_MEAN|0.114|<|0.0001||95.0|-0.813|-0.364|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||-0.364|-0.813|<0.0001
71092517|NCT01311661|141691437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.546|STANDARD_ERROR_OF_MEAN|0.114|<|0.0001||95.0|-0.77|-0.322|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||-0.322|-0.770|<0.0001
71092518|NCT01311661|141691442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.357|STANDARD_ERROR_OF_MEAN|0.053|<|0.0001||95.0|-0.461|-0.253|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||-0.253|-0.461|<0.0001
71092519|NCT01311661|141691442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.296|STANDARD_ERROR_OF_MEAN|0.053|<|0.0001||95.0|-0.4|-0.192|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||-0.192|-0.400|<0.0001
70911511|NCT02374957|141312992|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||"Null hypothesis: three-month change in EQ5D sum score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EQ5D than the other over three months (two-sided test)."||||0.17
70911512|NCT02374957|141312993|SUPERIORITY|||||||0.027|||||||t-test, 2 sided|||"Null hypothesis: six-week change in EQ5D visual analog score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EQ5D visual analog score than the other over initial six weeks (two-sided test)."||||0.027
70911513|NCT02374957|141312994|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||"Null hypothesis: three-month change in EQ5D visual analog score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EQ5D visual analog score than the other over three months (two-sided test)."||||0.014
70911514|NCT02374957|141312995|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||"Null hypothesis: six-week change in EACH Q sum score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EACH Q sum score than the other over initial six weeks (two-sided test)."||||0.82
70911515|NCT02374957|141312996|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||"Null hypothesis: three-month change in EACH Q sum score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EACH Q sum score than the other over three months (two-sided test)."||||0.61
70911516|NCT02374957|141312997|SUPERIORITY|||||||0.26|||||||Log Rank|||"Null hypothesis: time to patency-failure (graft occlusion) is the same between treatment arms.~Alternate hypothesis: one arm differs from the other in durability of graft patency (two-sided test)."||||0.26
70911517|NCT02334306|141313004|SUPERIORITY||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|1.3||0.262|TWO_SIDED|90.0|-3.6|0.7|||ANCOVA||Adjusted mean difference for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval and p-value.|||0.7|-3.6|0.262
70911518|NCT02334306|141313005|SUPERIORITY||Mean Difference (Net)|0.93|STANDARD_ERROR_OF_MEAN|0.33||0.82|TWO_SIDED|90.0|0.52|1.64|||ANCOVA||Adjusted Geometric mean ratio for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval, SE (log), and p-value.|For plasma cell levels||1.64|0.52|0.820
70911519|NCT02334306|141313005|SUPERIORITY||Median Difference (Net)|0.65|STANDARD_ERROR_OF_MEAN|0.4||0.291|TWO_SIDED|90.0|0.33|1.28|||ANCOVA||Adjusted Geometric mean ratio for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval, SE (log), and p-value.|For TFH cells||1.28|0.33|0.291
70911520|NCT02334306|141313006|SUPERIORITY||Mean Difference (Net)|0.87|STANDARD_ERROR_OF_MEAN|0.17||0.44|TWO_SIDED|90.0|0.65|1.18|||ANCOVA||Adjusted Geometric mean ratio for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval, SE (log), and p-value.|For total plasma cells||1.18|0.65|0.440
70911521|NCT02334306|141313006|SUPERIORITY||Median Difference (Net)|0.43|STANDARD_ERROR_OF_MEAN|0.28||0.008|TWO_SIDED|90.0|0.26|0.7|||ANCOVA||Adjusted Geometric mean ratio for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval, SE (log), and p-value.|For CD4/ICOS TFH cells||0.70|0.26|0.008
70911522|NCT02334306|141313006|SUPERIORITY||Median Difference (Net)|1.01|STANDARD_ERROR_OF_MEAN|0.26||0.972|TWO_SIDED|90.0|0.64|1.59|||ANCOVA||Adjusted Geometric mean ratio for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval, SE (log), and p-value.|For PD-1/ICOS TFH cells||1.59|0.64|0.972
70911523|NCT02334306|141313008|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.7||0.574|TWO_SIDED|90.0|-0.8|1.6|||ANCOVA||Adjusted mean difference for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval and p-value.|||1.6|-0.8|0.574
70911524|NCT02334306|141313009|SUPERIORITY||Difference in percentages|25.0||||0.252|TWO_SIDED|90.0|-3.1|50.9|||Fisher Exact|||ESSDAI \[3\]||50.9|-3.1|0.252
70911525|NCT02334306|141313009|SUPERIORITY||Difference in precentages|25.0||||0.252|TWO_SIDED|90.0|-3.1|50.9|||Fisher Exact|||ESSDAI\[4\]||50.9|-3.1|0.252
70911526|NCT02390557|141313034|SUPERIORITY||Mean Difference (Final Values)|10.7||||0.074|TWO_SIDED||||||Chi-squared, Corrected|||we had a prior hypothesis that the survey intervention would be associated with a larger increase in perceived quality of health care compared with control from Wave 1 to Wave 2||||0.074
70911527|NCT02390557|141313034|SUPERIORITY||Mean Difference (Final Values)|7.4||||0.069|TWO_SIDED||||||Chi-squared, Corrected|||We compared change in perception of quality of health care between Control v YES Health, wave 1 v Wave 2||||.069
70911528|NCT01360840|141313045|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.89|||||TWO_SIDED|95.0|0.57|1.39||||||||1.39|0.57|
70911529|NCT01360840|141313045|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.81|||||TWO_SIDED|95.0|0.52|1.26||||||||1.26|0.52|
70911530|NCT01360840|141313046|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.1|||||TWO_SIDED|95.0|0.52|2.31||||||||2.31|0.52|
70911531|NCT01360840|141313046|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.01|||||TWO_SIDED|95.0|0.47|2.15||||||||2.15|0.47|
70911532|NCT01360840|141313047|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.91|||||TWO_SIDED|95.0|0.58|1.44||||||||1.44|0.58|
70911533|NCT01360840|141313047|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.81|||||TWO_SIDED|95.0|0.52|1.27||||||||1.27|0.52|
70911534|NCT00293462|141313061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09||95.0|||||Fisher Exact|Two by two table was used. One cell had expected frequency test less than five, so Fisher's exact two-tailed test was used.||Fisher's exact two tailed test||||0.09
70911535|NCT00293462|141313062|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92|TWO_SIDED|95.0|||||Mantel Haenszel|Log rank, Breslow, Tarone-Ware test, but used mantel cox log rank for this analysis||Kaplan-Meier estimate of the survival curves used information from subjects who develop mucositis to the healing of the mucositis in three groups, Group GG, SS, and SG. In order to compare the three curves that were created, the Mantel-Haenszel log-rank statistic was used||||0.92
70911536|NCT00293462|141313063|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28||95.0||||0.28 (quadratic)|Mixed Models Analysis|Restricted Maximum Likelihood Methods with random intercepts was the only model used for the three groups and seven measurement time points.||Multilevel regression was used.||||0.28
70911537|NCT00293462|141313064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.78||95.0||||0.78 (quadratic)|Mixed Models Analysis|Restricted Maximum Likelihood Methods with random intercepts was the only model used for the three groups and seven measurement time points.||||||0.78
70911538|NCT00293462|141313065|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22||95.0||||0.22 (quadratic)|Mixed Models Analysis|Restricted Maximum Likelihood Methods with random intercepts was the only model used for the three groups and seven measurement time points.||||||0.22
70911539|NCT01579578|141313066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.0|STANDARD_ERROR_OF_MEAN|12.23||0.688|TWO_SIDED|95.0|-30.81|20.81||two sided p value|ANCOVA|ANCOVA model including covariates for baseline tumour size, for the time from the baseline scan to randomisation and with a term for HER2 status.|the difference in LS means is estimated|60 patients had been considered to detect a -20% difference in the estimated average percentage change in tumour size at 8 weeks for AZD8931 plus paclitaxel compared to paclitaxel alone at a one-sided significance level of 10% with 90% power. This is based on a standard deviation of 30% for tumour data (on an absolute scale)||20.81|-30.81|0.688
70911540|NCT00714233|141313074|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Paired t-test to analyze BMI at baseline and 24 weeks||||<0.05
70911541|NCT01813422|141313093|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-1.007|STANDARD_ERROR_OF_MEAN|0.187|<|0.0001|TWO_SIDED|95.0|-1.375|-0.64|||ANCOVA|ANCOVA model included terms for the treatment group, the geographic region stratification factor, and baseline PAV.|Treatment difference uses placebo as the reference.|||-0.640|-1.375|< 0.0001
70911542|NCT01813422|141313094|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-4.889|STANDARD_ERROR_OF_MEAN|1.201|<|0.0001|TWO_SIDED|95.0|-7.247|-2.531|||ANCOVA|ANCOVA model included terms for the treatment group, the geographic region stratification factor, and baseline TAV.|Treatment difference uses placebo as the reference.|||-2.531|-7.247|< 0.0001
70911543|NCT01813422|141313095|SUPERIORITY_OR_OTHER||Treatment Difference|17.0|||<|0.0001|TWO_SIDED|95.0|10.3|23.5|||Cochran-Mantel-Haenszel|Based on CMH test stratified by geographic region.|Treatment difference uses placebo as the reference.|||23.5|10.3|< 0.0001
70911544|NCT01813422|141313096|SUPERIORITY_OR_OTHER||Treatment Difference|12.5||||0.0002|TWO_SIDED|95.0|5.8|19.1|||Cochran-Mantel-Haenszel|Based on CMH test stratified by geographic region.|Treatment difference uses placebo as the reference.|||19.1|5.8|0.0002
70911545|NCT04889118|141313105|SUPERIORITY|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|0.55||||0.0013|TWO_SIDED|95.0|0.37|0.81||One-sided p-value based on log-rank test.|Log Rank||HR=Pembrolizumab + Lenvatinib vs. Pembrolizumab + Placebo|||0.81|0.37|0.0013
70911546|NCT04889118|141313106|SUPERIORITY|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|Hazard Ratio (HR)|0.93||||0.3728|TWO_SIDED|95.0|0.58|1.48||One-sided p-value based on log-rank test|Log Rank||HR=Pembrolizumab + Lenvatinib vs. Pembrolizumab + Placebo|||1.48|0.58|0.3728
70911547|NCT01928940|141313131|SUPERIORITY_OR_OTHER||Percentage|83.0|||<|0.0001|TWO_SIDED|95.0|35.9|99.6|||Exact binomial test||For Investigator Assessed ORR|||99.6|35.9|<0.0001
70911548|NCT01928940|141313131|SUPERIORITY_OR_OTHER||Percentage|83.0|||<|0.0001|TWO_SIDED|95.0|35.9|99.6|||Exact binomial test||BICR Assessed ORR|||99.6|35.9|<0.0001
70911549|NCT01928940|141313136|SUPERIORITY_OR_OTHER||Percentage|83.0|||<|0.0001|TWO_SIDED|95.0|35.9|99.6|||Exact binomial test||For Investigator Assessed ORR|||99.6|35.9|<0.0001
70911550|NCT01928940|141313136|SUPERIORITY_OR_OTHER||Percentage|50.0||||0.0158|TWO_SIDED|95.0|11.8|82.2|||Exact binomial test||BICR Assessed ORR|||82.2|11.8|0.0158
70911551|NCT01928940|141313137|SUPERIORITY_OR_OTHER||Percentage|83.0|||<|0.0001|TWO_SIDED|95.0|35.9|99.6|||Exact binomial test||For Investigator Assessed ORR|||99.6|35.9|<0.0001
70911552|NCT01928940|141313137|SUPERIORITY_OR_OTHER||Percentage|50.0||||0.0158|TWO_SIDED|95.0|11.8|88.2|||Exact binomial test||BICR Assessed ORR|||88.2|11.8|0.0158
70911553|NCT01928940|141313140|SUPERIORITY_OR_OTHER||Percentage|83.0|||<|0.0001|TWO_SIDED|95.0|35.9|99.6|||Exact binomial test||For Investigator Assessed ORR|||99.6|35.9|<0.0001
70911554|NCT01928940|141313140|SUPERIORITY_OR_OTHER||Percentage|83.0|||<|0.0001|TWO_SIDED|95.0|35.9|99.6|||Exact binomial test||BICR Assessed ORR|||99.6|35.9|<0.0001
70911555|NCT02408965|141313155|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.5
70911556|NCT02408965|141313156|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
70911557|NCT02408965|141313157|SUPERIORITY|||||||0.04|||||||Chi-squared|||||||0.04
70911558|NCT02408965|141313158|SUPERIORITY|||||||0.06|||||||Chi-squared|||||||0.06
70911559|NCT02408965|141313159|SUPERIORITY|||||||0.06|||||||Chi-squared|||||||0.06
70911560|NCT02408965|141313160|SUPERIORITY|||||||0.07|||||||Chi-squared|||||||0.07
70911561|NCT02408965|141313161|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
70911562|NCT02408965|141313162|SUPERIORITY|||||||0.03|||||||Chi-squared|||||||0.03
70911563|NCT02408965|141313163|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||0.02
70911564|NCT01352507|141313164|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilson Score method|||Null hypothesis (H0): The proportion of participants who chose tadalafil over sildenafil is equal to 0.5 (p = 0.5), versus alternative hypothesis (H1): p is not equal to 0.5 (2-sided test).||||<0.001
70911565|NCT01352507|141313166|SUPERIORITY_OR_OTHER||Least Squares (LS) mean difference|0.02||||0.793|TWO_SIDED|95.0|-0.11|0.15||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.15|-0.11|0.793
70911566|NCT01352507|141313167|SUPERIORITY_OR_OTHER||LS mean difference|0.01||||0.988|TWO_SIDED|95.0|-1.35|1.37||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||1.37|-1.35|0.988
70911567|NCT01352507|141313168|SUPERIORITY_OR_OTHER||LS mean difference|0.03||||0.102|TWO_SIDED|95.0|-0.01|0.08||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.08|-0.01|0.102
70911568|NCT01352507|141313170|SUPERIORITY_OR_OTHER||LS mean difference|-0.01||||0.861|TWO_SIDED|95.0|-0.22|0.19||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.19|-0.22|0.861
70911569|NCT01352507|141313171|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05||||0.495|TWO_SIDED|95.0|-0.19|0.09||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.09|-0.19|0.495
71092520|NCT01311661|141691442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.301|STANDARD_ERROR_OF_MEAN|0.053|<|0.0001||95.0|-0.405|-0.198|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||-0.198|-0.405|<0.0001
71092521|NCT01311661|141691442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.302|STANDARD_ERROR_OF_MEAN|0.053|<|0.0001||95.0|-0.405|-0.198|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||-0.198|-0.405|<0.0001
71092522|NCT00207740|141691444|SUPERIORITY_OR_OTHER|||||||0.802||||||When interpreting this p-value along with the other co-primary endpoint, Hochberg procedure was used.|ANCOVA|||The null hypothesis was that the endpoint for placebo is the same as that for combined 100 mg and 200 mg golimumab. Assuming a standard deviation of 23%, there is 86% power to detect a 10% difference at a 0.05 significance level.||||0.802
71092523|NCT00207740|141691444|SUPERIORITY_OR_OTHER|||||||0.945||||||The nominal p-value is for descriptive purpose only.|ANCOVA|||This is a secondary analysis.||||0.945
71092524|NCT00207740|141691444|SUPERIORITY_OR_OTHER|||||||0.717||||||The nominal p-value is for descriptive purpose only.|ANCOVA|||This is a secondary analysis.||||0.717
71092525|NCT00207740|141691444|SUPERIORITY_OR_OTHER|||||||0.357||||||The nominal p-value is for descriptive purpose only.|ANCOVA|||This is a secondary analysis.||||0.357
71092526|NCT00207740|141691445|SUPERIORITY_OR_OTHER|||||||0.286|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that the endpoint for placebo is the same as that in the combined 100 mg and 200 mg golimumab.||||0.286
71092527|NCT00207740|141691445|SUPERIORITY_OR_OTHER|||||||0.742|||||||Wilcoxon (Mann-Whitney)|||||||0.742
71092528|NCT00207740|141691445|SUPERIORITY_OR_OTHER|||||||0.128|||||||Wilcoxon (Mann-Whitney)|||||||0.128
71092529|NCT00207740|141691445|SUPERIORITY_OR_OTHER|||||||0.946|||||||Wilcoxon (Mann-Whitney)|||||||0.946
71092530|NCT00207740|141691446|SUPERIORITY_OR_OTHER|||||||0.718||||||When interpreting this p-value along with the other co-primary endpoint, Hochberg procedure was used.|Cochran-Mantel-Haenszel|||The null hypothesis was that the number of severe exacerbations per patient from baseline through week 24 for placebo is the same as that in the combined 100 mg and 200 mg golimumab. Assuming 1 severe exacerbation over 6 months per patient in the placebo group, there is 79% power to detect a 35% reduction in the combined 100 mg and 200 mg golimumab group at a 0.05 significance level.||||0.718
71092531|NCT00207740|141691446|SUPERIORITY_OR_OTHER|||||||0.779||||||The nominal p-value is for descriptive purpose only.|Cochran-Mantel-Haenszel|||This is a secondary analysis.||||0.779
71092532|NCT00207740|141691446|SUPERIORITY_OR_OTHER|||||||0.649||||||The nominal p-value is for descriptive purpose only.|Cochran-Mantel-Haenszel|||This is a secondary analysis.||||0.649
71092533|NCT00207740|141691446|SUPERIORITY_OR_OTHER|||||||0.256||||||The nominal p-value is for descriptive purpose only.|Cochran-Mantel-Haenszel|||This is a secondary analysis.||||0.256
71092534|NCT00207740|141691447|SUPERIORITY_OR_OTHER|||||||0.894|||||||Kruskal-Wallis|||The null hypothesis was that the endpoint for placebo is the same as that in the combined 100 mg and 200 mg golimumab.||||0.894
71092535|NCT00207740|141691447|SUPERIORITY_OR_OTHER|||||||0.572|||||||Kruskal-Wallis|||||||0.572
71092536|NCT00207740|141691447|SUPERIORITY_OR_OTHER|||||||0.731|||||||Kruskal-Wallis|||||||0.731
71092537|NCT00207740|141691447|SUPERIORITY_OR_OTHER|||||||0.856|||||||Kruskal-Wallis|||||||0.856
71092538|NCT00207740|141691448|SUPERIORITY_OR_OTHER|||||||0.273|||||||Cochran-Mantel-Haenszel|||The null hypothesis was that the endpoint for placebo is the same as that in the combined 100 mg and 200 mg golimumab.||||0.273
71092539|NCT00207740|141691448|SUPERIORITY_OR_OTHER|||||||0.382|||||||Cochran-Mantel-Haenszel|||||||0.382
71092540|NCT00207740|141691448|SUPERIORITY_OR_OTHER|||||||0.35|||||||Cochran-Mantel-Haenszel|||||||0.350
71092541|NCT00207740|141691448|SUPERIORITY_OR_OTHER|||||||0.341|||||||Cochran-Mantel-Haenszel|||||||0.341
71092542|NCT00207740|141691449|SUPERIORITY_OR_OTHER|||||||0.986|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that the endpoint for placebo is the same as that in the combined 100 mg and 200 mg golimumab.||||0.986
71092543|NCT00207740|141691449|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.820
71092544|NCT00207740|141691449|SUPERIORITY_OR_OTHER|||||||0.858|||||||Wilcoxon (Mann-Whitney)|||||||0.858
71092545|NCT00207740|141691449|SUPERIORITY_OR_OTHER|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
71092546|NCT00207740|141691450|SUPERIORITY_OR_OTHER|||||||0.833||95.0|||||ANOVA|||The null hypothesis was that the endpoint for placebo is the same as that in the combined 100 mg and 200 mg golimumab.||||0.833
71092547|NCT00207740|141691450|SUPERIORITY_OR_OTHER|||||||0.814||95.0|||||ANOVA|||||||0.814
71092548|NCT00207740|141691450|SUPERIORITY_OR_OTHER|||||||0.897||95.0|||||ANOVA|||||||0.897
71092549|NCT00207740|141691450|SUPERIORITY_OR_OTHER|||||||0.726||95.0|||||ANOVA|||||||0.726
71092550|NCT00770809|141691485|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|TWO_SIDED|||||Participants were stratified by clinical stage (II vs III) and hormone receptor status (positive/negative).|Log Rank|||||||0.13
71092551|NCT00770809|141691485|SUPERIORITY_OR_OTHER_LEGACY|||||||0.072|TWO_SIDED|||||Participants were stratified by clinical stage (II vs III) and hormone receptor status (positive/negative).|Log Rank|||||||0.072
71092552|NCT06023563|141691502|OTHER|The required sample size for medium effect size (f = 0.25) and power of 0.80 was calculated to be 6 participants in each group (n =12) (G\*power 3.1.9.7 software). Data were analyzed using IBM SPSS statistical package (version 29.0.1.0).|||||<|0.05|||||||Friedman's test|||A virtual reality active video gaming intervention will be more effective than traditional physical therapy based balance exercises, both based on motor learning principles, in improving static and dynamic balance in youth and young adults with ASD and these improvements will be retained at 4 weeks after the intervention.||||< 0.05
71092553|NCT06023563|141691503|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
71092554|NCT06023563|141691504|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
71092555|NCT06023563|141691505|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
71092556|NCT06023563|141691506|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
71092557|NCT06023563|141691507|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
70911570|NCT01352507|141313172|SUPERIORITY_OR_OTHER||LS mean difference|-0.01||||0.917|TWO_SIDED|95.0|-0.18|0.16||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.16|-0.18|0.917
70911571|NCT01352507|141313173|SUPERIORITY_OR_OTHER||LS mean difference|1.23||||0.391|TWO_SIDED|95.0|-1.58|4.04||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||4.04|-1.58|0.391
70911572|NCT01352507|141313174|SUPERIORITY_OR_OTHER||LS mean difference|0.13|||<|0.001|TWO_SIDED|95.0|0.09|0.18||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.18|0.09|<0.001
70911573|NCT01352507|141313175|SUPERIORITY_OR_OTHER||LS mean difference|-0.14|||<|0.001|TWO_SIDED|95.0|-0.19|-0.09||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||-0.09|-0.19|<0.001
70911574|NCT01352507|141313176|SUPERIORITY_OR_OTHER||LS mean difference|0.18||||0.364|TWO_SIDED|95.0|-0.2|0.55||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.55|-0.20|0.364
70911575|NCT04824131|141313231|OTHER||Exact CI for Proportions|0.0|||||TWO_SIDED|95.0|0.0|6.7|||||||Exact 95% Confidence Interval for Proportion for Participants who Discontinued Early due to Intolerability of Injection or Burden of Study Procedures|6.7|0|
70911576|NCT04824131|141313232|OTHER||Exact CI for Proportions|61.5|||||TWO_SIDED|95.0|47.0|74.7|||||||Exact 95% confidence interval for proportion for Participants who received at least one injection and preferred injectable PrEP at end of step 2.|74.7|47.0|
70911577|NCT04824131|141313235|OTHER||Exact CI for Proportions|94.3|||||TWO_SIDED|95.0|84.3|98.8|||||||The Exact 95% Confidence Interval for Proportion for Number of Participants with Grade 2 or above AEs during Injection Phase|98.8|84.3|
70911578|NCT04824131|141313236|OTHER||Exact CI for Proportions|100.0|||||TWO_SIDED|95.0|93.3|100.0|||||||Exact 95% Confidence Interval for Proportion for Participants who received at least one Injection who Completed All Scheduled Injections|100|93.3|
70911579|NCT04824131|141313237|OTHER||Mean Difference (Final Values)|-0.2728|STANDARD_ERROR_OF_MEAN|0.1704||0.1093|TWO_SIDED|95.0|-0.61|0.06||"GEE for Change in Sexual Behavior - Number of Sexual Partners - Visit as Continuous Variable.~Difference from baselines in the number of sex partners (vaginal or anal sex) reported in the past month"|poisson model||"GEE for Change in Sexual Behavior - Number of Sexual Partners - Visit as Continuous Variable.~Difference from baselines in the number of sex partners (vaginal or anal sex) reported in the past month"|Generalized estimating equations (GEE) with robust variance to model change in self-reported sexual behavior from enrollment (W0) to follow up visits (W4, W5, W9, W17, W25, W33, W+12, W+24, W+36, W+48), with an indicator variable for all on-study visits (i.e. enrollment visit = 0) to measure change in the outcome behavior. We will model count outcomes (number of sexual partners) using a poisson model.||0.06|-0.61|0.1093
70911580|NCT04824131|141313238|OTHER||Mean Difference (Final Values)|-0.5859|STANDARD_ERROR_OF_MEAN|0.2253||0.0093|TWO_SIDED|95.0|-1.03|-0.14||GEE for Change in Sexual Behavior - Number of Episodes of Vaginal Sex without a Condom - Visit as Continuous Variable. Difference from baselines in the number of vaginal sex without a condom reported in the past month|poisson model||GEE for Change in Sexual Behavior - Number of Episodes of Vaginal Sex without a Condom - Visit as Continuous Variable. Difference from baselines in the number of vaginal sex without a condom reported in the past month.|Generalized estimating equations (GEE) with robust variance to model change in self-reported sexual behavior from enrollment (W0) to follow up visits (W4, W5, W9, W17, W25, W33, W+12, W+24, W+36, W+48), with an indicator variable for all on-study visits (i.e. enrollment visit = 0) to measure change in the outcome behavior. We will model count outcomes (number of episodes of vaginal sex without a condom) using a poisson model.||-0.14|-1.03|0.0093
70911581|NCT04824131|141313238|OTHER||Mean Difference (Final Values)|-0.3087|STANDARD_ERROR_OF_MEAN|1.4036||0.8259|TWO_SIDED|95.0|-3.06|2.44||GEE for Change in Sexual Behavior - Number of Episodes of Anal Sex without a Condom - Visit as Continuous Variable. Difference from baselines in the number of anal sex without a condom reported in the past month|Regression, Logistic||GEE for Change in Sexual Behavior - Number of Episodes of Anal Sex without a Condom - Visit as Continuous Variable. Difference from baselines in the number of anal sex without a condom reported in the past month|Generalized estimating equations (GEE) with robust variance to model change in self-reported sexual behavior from enrollment (W0) to follow up visits (W4, W5, W9, W17, W25, W33, W+12, W+24, W+36, W+48), with an indicator variable for all on-study visits (i.e. enrollment visit = 0) to measure change in the outcome behavior. We will model binary outcomes (any episodes of anal sex without a condom) using a logistic model.||2.44|-3.06|0.8259
70911582|NCT04824131|141313239|OTHER||CI for Incidence rate, exact Poisson|0.0|||||TWO_SIDED|95.0|0.0|10.8|||||Person-years: 34.0||Incidence rate is calculated HIV infections per 100 person years. CI for Incidence rate is calculated using exact Poisson method|10.8|0.0|
70911583|NCT04939428|141313259|SUPERIORITY||Confidence Interval|-2.0|||=|0.0848|TWO_SIDED|95.0|-5.0|0.9|||Miettinen & Nurminen method|||Adjusted differences and the corresponding confidence intervals are based on Miettinen \& Nurminen method stratified by age and household size.||0.9|-5|= 0.0848
70911584|NCT04939428|141313260|OTHER|Estimated differences and confidence intervals are provided.|Confidence Interval|-1.4|||||TWO_SIDED|95.0|-4.8|2.0|||Miettinen & Nurminen method|||95% CIs (Tier 2 endpoints) was provided for between treatment differences in the percentage of participants with events; these analyses was performed using the Miettinen and Nurminen method.||2.0|-4.8|
71092558|NCT06023563|141691508|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
71092559|NCT06023563|141691509|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
71092560|NCT01932606|141691512|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||ANCOVA|||||||0.0003
71092561|NCT01932606|141691513|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in right atrial pressure.||||0.0003
71092562|NCT01932606|141691513|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in pulmonary artery systolic pressure.||||0.01
71092563|NCT01932606|141691513|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in mean pulmonary artery pressure.||||0.002
71092564|NCT01932606|141691513|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Comparison between the 2 arms for change in PCWP.||||<0.0001
71092565|NCT01932606|141691514|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||t-test, 2 sided|||||||0.15
71092566|NCT01932606|141691515|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in systolic blood pressure.||||0.11
71092567|NCT01932606|141691515|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in mean blood pressure.||||0.2
71092568|NCT01932606|141691516|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in PVR.||||0.7
71092569|NCT01932606|141691517|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in pulmonary artery compliance.||||0.1
71092570|NCT01932606|141691518|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in SVR.||||0.3
71092571|NCT01932606|141691519|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in LVSW.||||0.3
71092572|NCT01932606|141691520|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in VO\_2.||||0.8
71092573|NCT01932606|141691521|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for arteriovenous oxygen content difference.||||0.1
71092574|NCT01932606|141691522|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in cardiac output.||||0.4
71092575|NCT01932606|141691523|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in stroke volume.||||0.4
71092576|NCT01932606|141691524|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in right atrial pressure (exercise).||||0.0002
71092577|NCT01932606|141691524|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in pulmonary artery systolic pressure (exercise).||||0.01
71092578|NCT01932606|141691524|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in mean pulmonary artery pressure (exercise).||||0.0002
71092579|NCT01932606|141691524|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in PCWP (exercise).||||0.0002
71092580|NCT01932606|141691525|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in heart rate.||||0.3
71092581|NCT01932606|141691526|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in systolic blood pressure.||||0.2
71092582|NCT01932606|141691526|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in diastolic blood pressure.||||0.05
71092583|NCT01932606|141691527|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in PVR after study drug (exercise)||||0.3
71092584|NCT01932606|141691528|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in PA compliance after study drug (exercise)||||0.3
71092585|NCT01932606|141691529|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in SVR after study drug (exercise).||||0.007
71092586|NCT01932606|141691530|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in LVSW after study drug (exercise)||||0.0003
71092587|NCT01932606|141691531|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in oxygen consumption (VO\_2) after study drug (exercise).||||0.02
71092588|NCT01932606|141691532|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in arteriovenous oxygen difference after study drug (exercise).||||0.6
71092589|NCT01932606|141691533|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in cardiac output after study drug (exercise).||||0.002
71092590|NCT01932606|141691534|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in stroke volume after study drug (exercise).||||0.0002
71092591|NCT03329001|141691542|OTHER||Ratio of geometric least square mean|0.911|||||TWO_SIDED|90.0|0.855|0.9706|||||Relative bioavailability (AUC\[tablet\]/AUC\[capsule\]) was assessed using analysis of variance (ANOVA) model accounting for sequence, participants nested with sequences, period and treatment.|||0.9706|0.8550|
71092592|NCT03329001|141691543|OTHER||Ratio of geometric least square mean|0.9216|||||TWO_SIDED|90.0|0.8631|0.9841|||||Relative bioavailability (AUC\[tablet\]/AUC\[capsule\]) was assessed using ANOVA model accounting for sequence, participants nested with sequences, period and treatment.|||0.9841|0.8631|
71092593|NCT03329001|141691544|OTHER||Ratio of geometric least square mean|0.9483|||||TWO_SIDED|90.0|0.8489|1.0593|||||Relative bioavailability (Cmax\[tablet\]/Cmax\[capsule\]) was assessed using ANOVA model accounting for sequence, participants nested with sequences, period and treatment.|||1.0593|0.8489|
71092594|NCT03329001|141691549|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval of the ratio of geometric least-squares means of the test (tablet) to reference (capsule) product was within 0.80 - 1.25% for AUC0-t|Ratio of geometric least square mean|0.9594|||||TWO_SIDED|90.0|0.9199|1.0006|||||Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence. Ratio of geometric least square mean of niraparib tablet to niraparib capsule is presented.|||1.0006|0.9199|
71092595|NCT03329001|141691550|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval of the ratio of geometric least-squares means of the test (tablet) to reference (capsule) product was within 0.80 - 1.25% for AUC0-inf|Ratio of geometric least square mean|0.9566|||||TWO_SIDED|90.0|0.9164|0.9986|||||Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence. Ratio of geometric least square mean of niraparib tablet to niraparib capsule is presented.|||0.9986|0.9164|
70911585|NCT04939428|141313261|OTHER|Estimated differences and confidence intervals are provided|Confidence Interval|0.3|||||TWO_SIDED|95.0|-0.4|1.0|||Miettinen & Nurminen method.|||95% CIs (Tier 2 endpoints) was provided for between treatment differences in the percentage of participants with events; these analyses was performed using the Miettinen and Nurminen method.||1.0|-0.4|
70911586|NCT04939428|141313262|SUPERIORITY||Confidence Interval|-3.2|||=|0.0205|TWO_SIDED|95.0|-6.3|-0.1|||Miettinen & Nurminen method|||Adjusted differences and the corresponding confidence intervals are based on Miettinen \& Nurminen method stratified by age and household size.||-0.1|-6.3|= 0.0205
70911587|NCT04939428|141313263|OTHER|Adjusted differences and the corresponding confidence intervals.|Confidence Interval|-2.2|||||TWO_SIDED|95.0|-5.4|1.0|||Miettinen & Nurminen method|||Adjusted differences and the corresponding confidence intervals are based on Miettinen \& Nurminen method stratified by age and household size.||1.0|-5.4|
70911588|NCT04939428|141313264|OTHER|Adjusted differences and the corresponding confidence intervals|Confidence Interval|-3.0|||||TWO_SIDED|95.0|-6.9|0.8||||||Adjusted differences and the corresponding confidence intervals are based on Miettinen \& Nurminen method stratified by age and household size.||0.8|-6.9|
70911589|NCT04939428|141313265|OTHER|Adjusted differences and the corresponding confidence intervals.|Mean Difference (Final Values)|-10.5|||||TWO_SIDED|95.0|-22.7|2.0|||Miettinen & Nurminen method|||Adjusted differences and the corresponding confidence intervals are based on Miettinen \& Nurminen method stratified by age and household size.||2.0|-22.7|
70911590|NCT02696785|141313266|SUPERIORITY||Odds Ratio (OR)|2.73||||0.005|TWO_SIDED|95.0|1.35|5.52|||Regression, Logistic|||Overall Work Impairment Score||5.52|1.35|0.005
70911591|NCT02696785|141313266|SUPERIORITY||Odds Ratio (OR)|4.45|||<|0.001|TWO_SIDED|95.0|2.2|9.03|||Regression, Logistic|||Overall Work Impairment Score.||9.03|2.20|<0.001
70911592|NCT02696785|141313266|SUPERIORITY||Odds Ratio (OR)|5.09|||<|0.001|TWO_SIDED|95.0|2.52|10.28|||Regression, Logistic|||Overall Work Impairment Score.||10.28|2.52|<0.001
70911593|NCT02696785|141313266|SUPERIORITY||LSMean Difference|-7.0|STANDARD_ERROR_OF_MEAN|3.16|<|0.001|TWO_SIDED|95.0|-13.2|-0.7|||ANCOVA|||Percentage of Activity Impairment||-0.7|-13.2|<0.001
70911594|NCT02696785|141313266|SUPERIORITY||LSMean Difference|-9.3|STANDARD_ERROR_OF_MEAN|3.19|<|0.001|TWO_SIDED|95.0|-15.5|-3.0|||ANCOVA|||Percentage of Activity Impairment||-3.0|-15.5|<0.001
70911595|NCT02696785|141313266|SUPERIORITY||LSMean Difference|-8.9|STANDARD_ERROR_OF_MEAN|3.22|<|0.001|TWO_SIDED|95.0|-15.2|-2.5|||ANCOVA|||Percentage of Activity Impairment||-2.5|-15.2|<0.001
70911596|NCT02696785|141313267|SUPERIORITY||Odds Ratio (OR)|2.3||||0.007|TWO_SIDED|95.0|1.25|4.23|||Regression, Logistic|||||4.23|1.25|0.007
70911597|NCT02696785|141313267|SUPERIORITY||Odds Ratio (OR)|2.78||||0.001|TWO_SIDED|95.0|1.48|5.24|||Regression, Logistic|||||5.24|1.48|0.001
70911598|NCT02696785|141313267|SUPERIORITY||Odds Ratio (OR)|3.39|||<|0.001|TWO_SIDED|95.0|1.79|6.41|||Regression, Logistic|||||6.41|1.79|<0.001
70911599|NCT02696785|141313268|SUPERIORITY||LSMean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.137|<|0.001|TWO_SIDED|95.0|-1.11|-0.57|||Mixed Models Analysis|||||-0.57|-1.11|<0.001
70911600|NCT02696785|141313268|SUPERIORITY||LSMean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.141|<|0.001|TWO_SIDED|95.0|-1.25|-0.7|||Mixed Models Analysis|||||-0.70|-1.25|<0.001
70911601|NCT02696785|141313268|SUPERIORITY||LSMean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.18|-0.63|||Mixed Models Analysis|||||-0.63|-1.18|<0.001
70911602|NCT02696785|141313269|SUPERIORITY||Odds Ratio (OR)|2.53||||0.012|TWO_SIDED|95.0|1.23|5.21|||Regression, Logistic|||||5.21|1.23|0.012
70911603|NCT02696785|141313269|SUPERIORITY||Odds Ratio (OR)|3.74|||<|0.001|TWO_SIDED|95.0|1.82|7.7|||Regression, Logistic|||||7.70|1.82|<0.001
70911604|NCT02696785|141313269|SUPERIORITY||Odds Ratio (OR)|3.9|||<|0.001|TWO_SIDED|95.0|1.91|7.98|||Regression, Logistic|||||7.98|1.91|<0.001
70911605|NCT02696785|141313270|SUPERIORITY||LSMean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.299||0.001|TWO_SIDED|95.0|-1.56|-0.39|||Mixed Models Analysis|||||-0.39|-1.56|0.001
70911606|NCT02696785|141313270|SUPERIORITY||LSMean Difference|-1.22|STANDARD_ERROR_OF_MEAN|0.307|<|0.001|TWO_SIDED|95.0|-1.83|-0.62|||Mixed Models Analysis|||||-0.62|-1.83|<0.001
70911607|NCT02696785|141313270|SUPERIORITY||LSMean Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.304|<|0.001|TWO_SIDED|95.0|-1.86|-0.67|||Mixed Models Analysis|||||-0.67|-1.86|<0.001
70911608|NCT02696785|141313271|SUPERIORITY||LSMean Difference|7.62||||0.009|TWO_SIDED|95.0|1.67|34.68|||Regression, Logistic|||||34.68|1.67|0.009
70911609|NCT02696785|141313271|SUPERIORITY||Odds Ratio (OR)|8.03||||0.007|TWO_SIDED|95.0|1.75|36.83|||Regression, Logistic|||||36.83|1.75|0.007
70911610|NCT02696785|141313271|SUPERIORITY||Odds Ratio (OR)|5.13||||0.041|TWO_SIDED|95.0|1.07|24.49|||Regression, Logistic|||||24.49|1.07|0.041
70911611|NCT02696785|141313272|SUPERIORITY||LSMean Difference|-2.78|STANDARD_ERROR_OF_MEAN|0.447|<|0.001|TWO_SIDED|95.0|-3.7|-1.9|||ANCOVA|||||-1.9|-3.7|<0.001
70911612|NCT02696785|141313272|SUPERIORITY||LSMean Difference|-2.62|STANDARD_ERROR_OF_MEAN|0.45|<|0.001|TWO_SIDED|95.0|-3.5|-1.7|||ANCOVA|||||-1.7|-3.5|<0.001
70911613|NCT02696785|141313272|SUPERIORITY||LSMean Difference|-2.39|STANDARD_ERROR_OF_MEAN|0.452|<|0.001|TWO_SIDED|95.0|-3.3|-1.5|||ANCOVA|||||-1.5|-3.3|<0.001
70911614|NCT02696785|141313273|SUPERIORITY||LSMean Difference|3.2574|STANDARD_ERROR_OF_MEAN|1.0437||0.002|TWO_SIDED|95.0|1.2041|5.3106|||Mixed Models Analysis|||PCS||5.3106|1.2041|0.002
70911615|NCT02696785|141313273|SUPERIORITY||LSMean Difference|4.052|STANDARD_ERROR_OF_MEAN|1.072|<|0.001|TWO_SIDED|95.0|1.9432|6.1608|||Mixed Models Analysis|||PCS||6.1608|1.9432|<0.001
70911616|NCT02696785|141313273|SUPERIORITY||LSMean Difference|4.3254|STANDARD_ERROR_OF_MEAN|1.0641|<|0.001|TWO_SIDED|95.0|2.2321|6.4186|||Mixed Models Analysis|||PCS||6.4186|2.2321|<0.001
70911617|NCT02696785|141313273|SUPERIORITY||LSMean Difference|0.4321|STANDARD_ERROR_OF_MEAN|1.1718||0.713|TWO_SIDED|95.0|-1.8732|2.7373|||Mixed Models Analysis|||MCS||2.7373|-1.8732|0.713
70911618|NCT02696785|141313273|SUPERIORITY||LSMean Difference|0.6273|STANDARD_ERROR_OF_MEAN|1.2028||0.602|TWO_SIDED|95.0|-1.7387|2.9934|||Mixed Models Analysis|||MCS||2.9934|-1.7387|0.602
70911619|NCT02696785|141313273|SUPERIORITY||LSMean Difference|0.4467|STANDARD_ERROR_OF_MEAN|1.1978||0.709|TWO_SIDED|95.0|-1.9097|2.803|||Mixed Models Analysis|||MCS||2.8030|-1.9097|0.709
70911620|NCT02696785|141313274|SUPERIORITY||LSMean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.416||0.012|TWO_SIDED|95.0|-1.87|-0.23|||Mixed Models Analysis|||||-0.23|-1.87|0.012
70911621|NCT02696785|141313274|SUPERIORITY||LSMean Difference|-1.11|STANDARD_ERROR_OF_MEAN|0.428||0.01|TWO_SIDED|95.0|-1.95|-0.27|||Mixed Models Analysis|||||-0.27|-1.95|0.010
70911622|NCT02696785|141313274|SUPERIORITY||LSMean Difference|-1.49|STANDARD_ERROR_OF_MEAN|0.423|<|0.001|TWO_SIDED|95.0|-2.32|-0.66|||Mixed Models Analysis|||||-0.66|-2.32|<0.001
70911623|NCT02696785|141313275|SUPERIORITY||LSMean Difference|-8.628|STANDARD_ERROR_OF_MEAN|2.6724||0.001|TWO_SIDED|95.0|-13.885|-3.371|||Mixed Models Analysis|||||-3.371|-13.885|0.001
70911624|NCT02696785|141313275|SUPERIORITY||LSMean Difference|-6.635|STANDARD_ERROR_OF_MEAN|2.7438||0.016|TWO_SIDED|95.0|-12.033|-1.238|||Mixed Models Analysis|||||-1.238|-12.033|0.016
70911625|NCT02696785|141313275|SUPERIORITY||LSMean Difference|-7.991|STANDARD_ERROR_OF_MEAN|2.7248||0.004|TWO_SIDED|95.0|-13.351|-2.631|||Mixed Models Analysis|||||-2.631|-13.351|0.004
70911626|NCT02696785|141313276|SUPERIORITY||LSMean Difference|-0.367|STANDARD_ERROR_OF_MEAN|0.1143||0.001|TWO_SIDED|95.0|-0.592|-0.142|||Mixed Models Analysis|||||-0.142|-0.592|0.001
70911627|NCT02696785|141313276|SUPERIORITY||LSMean Difference|-0.422|STANDARD_ERROR_OF_MEAN|0.1184|<|0.001|TWO_SIDED|95.0|-0.655|-0.189|||Mixed Models Analysis|||||-0.189|-0.655|<0.001
70911628|NCT02696785|141313276|SUPERIORITY||LSMean Difference|-0.329|STANDARD_ERROR_OF_MEAN|0.1167||0.005|TWO_SIDED|95.0|-0.558|-0.099|||Mixed Models Analysis|||||-0.099|-0.558|0.005
70911629|NCT02696785|141313277|SUPERIORITY||LSMean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.211||0.003|TWO_SIDED|95.0|0.22|1.05|||Mixed Models Analysis|||||1.05|0.22|0.003
70911630|NCT02696785|141313277|SUPERIORITY||LSMean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.219||0.051|TWO_SIDED|95.0|0.0|0.86|||Mixed Models Analysis|||||0.86|-0.00|0.051
71092596|NCT03329001|141691551|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval of the ratio of geometric least-squares means of the test (tablet) to reference (capsule) product was within 0.80 - 1.25% for Cmax|Ratio of geometric least square mean|0.9619|||||TWO_SIDED|90.0|0.9124|1.014|||||Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence. Ratio of geometric least square mean of niraparib tablet to niraparib capsule is presented.|||1.0140|0.9124|
71092597|NCT03329001|141691556|OTHER||Ratio of geometric least square mean|1.3154|||||TWO_SIDED|90.0|1.1742|1.4735|||||Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence.|||1.4735|1.1742|
71092598|NCT03329001|141691557|OTHER||Ratio of geometric least square mean|1.2771|||||TWO_SIDED|90.0|1.1537|1.4137|||||Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence.|||1.4137|1.1537|
71092599|NCT03329001|141691558|OTHER||Ratio of geometric least square mean|1.1129|||||TWO_SIDED|90.0|0.9408|1.3164|||||Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence.|||1.3164|0.9408|
71092600|NCT02178956|141691572|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.8596|TWO_SIDED|95.0|0.86|1.02||two-sided|Log Rank|stratified log rank test stratified by region, time to progression on 1st line therapy and disease measurability.|HR is for napabucasin + Paclitaxel vs Placebo + Paclitaxel. Based on Cox Proportional hazards model stratified by actual stratification variables including region, time to progression on first line therapy and disease measurability.|||1.02|0.86|0.8596
71092601|NCT02178956|141691573|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9028|TWO_SIDED|95.0|0.85|1.19||two sided|Log Rank|stratified log rank test stratified by region, time to progression on 1st line therapy and disease measurability.|HR is for napabucuasin + Paclitaxel vs Placebo + Paclitaxel. Based on Cox Proportional hazards model stratified by actual stratification variables including region, time to progression on first line therapy and disease measurability.|||1.19|0.85|0.9028
70911631|NCT02696785|141313277|SUPERIORITY||LSMean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.215||0.005|TWO_SIDED|95.0|0.18|1.03|||Mixed Models Analysis|||||1.03|0.18|0.005
70911632|NCT02696785|141313278|SUPERIORITY||LSMean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.321||0.039|TWO_SIDED|95.0|-1.3|-0.03|||Mixed Models Analysis|||||-0.03|-1.30|0.039
70911633|NCT02696785|141313278|SUPERIORITY||LSMean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.33||0.057|TWO_SIDED|95.0|-1.28|0.02|||Mixed Models Analysis|||||0.02|-1.28|0.057
70911634|NCT02696785|141313278|SUPERIORITY||LSMean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.327||0.042|TWO_SIDED|95.0|-1.31|-0.03|||Mixed Models Analysis|||||-0.03|-1.31|0.042
70911635|NCT02696785|141313279|SUPERIORITY||LSMean Difference|-5.13|STANDARD_ERROR_OF_MEAN|0.806|<|0.001|TWO_SIDED|95.0|-6.7|-3.5|||ANCOVA|||||-3.5|-6.7|<0.001
70911636|NCT02696785|141313279|SUPERIORITY||LSMean Difference|-4.89|STANDARD_ERROR_OF_MEAN|0.812|<|0.001|TWO_SIDED|95.0|-6.5|-3.3|||ANCOVA|||||-3.3|-6.5|<0.001
70911637|NCT02696785|141313279|SUPERIORITY||LSMean Difference|-5.17|STANDARD_ERROR_OF_MEAN|0.816|<|0.001|TWO_SIDED|95.0|-6.8|-3.6|||ANCOVA|||||-3.6|-6.8|<0.001
70911638|NCT02696785|141313280|SUPERIORITY||LSMean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.48||0.317|TWO_SIDED|95.0|-1.4|0.5|||Mixed Models Analysis|||||0.5|-1.4|0.317
70911639|NCT02696785|141313280|SUPERIORITY||LSMean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.48||0.683|TWO_SIDED|95.0|-1.1|0.8|||Mixed Models Analysis|||||0.8|-1.1|0.683
70911640|NCT02696785|141313280|SUPERIORITY||LSMean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.48||0.5|TWO_SIDED|95.0|-1.3|0.6|||Mixed Models Analysis|||||0.6|-1.3|0.500
70911641|NCT02696785|141313281|SUPERIORITY||LSMean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.56||0.154|TWO_SIDED|95.0|-1.9|0.3|||Mixed Models Analysis|||||0.3|-1.9|0.154
70911642|NCT02696785|141313281|SUPERIORITY||LSMean Difference|0.255|STANDARD_ERROR_OF_MEAN|0.56||-0.6|TWO_SIDED|95.0|-1.8|0.5|||Mixed Models Analysis|||||0.5|-1.8|-0.6
70911643|NCT02696785|141313281|SUPERIORITY||LSMean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.58||0.398|TWO_SIDED|95.0|-1.6|0.7|||Mixed Models Analysis|||||0.7|-1.6|0.398
70911644|NCT02696785|141313282|SUPERIORITY||LSMean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.76||0.783|TWO_SIDED|95.0|-1.7|1.3|||Mixed Models Analysis|||||1.3|-1.7|0.783
70911645|NCT02696785|141313282|SUPERIORITY||LSMean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.78||0.55|TWO_SIDED|95.0|-2.0|1.1|||Mixed Models Analysis|||||1.1|-2.0|0.550
70911646|NCT02696785|141313282|SUPERIORITY||LSMean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.77||0.091|TWO_SIDED|95.0|-2.8|0.2|||Mixed Models Analysis|||||0.2|-2.8|0.091
70911647|NCT02696785|141313284|SUPERIORITY||LSMean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.32||0.027|TWO_SIDED|95.0|-1.3|-0.1|||Mixed Models Analysis|||||-0.1|-1.3|0.027
70911648|NCT02696785|141313284|SUPERIORITY||LSMean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.33||0.002|TWO_SIDED|95.0|-1.7|-0.4|||Mixed Models Analysis|||||-0.4|-1.7|0.002
70911649|NCT02696785|141313284|SUPERIORITY||LSMean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.33||0.035|TWO_SIDED|95.0|-1.3|0.0|||Mixed Models Analysis|||||-0.0|-1.3|0.035
70911650|NCT02696785|141313285|SUPERIORITY||LSMean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.57||0.041|TWO_SIDED|95.0|-2.3|0.0|||Mixed Models Analysis|||||-0.0|-2.3|0.041
70911651|NCT02696785|141313285|SUPERIORITY||LSMean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.59||0.125|TWO_SIDED|95.0|-2.1|0.3|||Mixed Models Analysis|||||0.3|-2.1|0.125
70911652|NCT02696785|141313285|SUPERIORITY||LSMean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.58||0.013|TWO_SIDED|95.0|-2.6|-0.3|||Mixed Models Analysis|||||-0.3|-2.6|0.013
70911653|NCT02696785|141313286|SUPERIORITY||LSMean Difference|0.04|STANDARD_ERROR_OF_MEAN|3.082||0.989|TWO_SIDED|95.0|-6.03|6.12|||Mixed Models Analysis|||||6.12|-6.03|0.989
70911654|NCT02696785|141313286|SUPERIORITY||LSMean Difference|2.5|STANDARD_ERROR_OF_MEAN|3.146||0.429|TWO_SIDED|95.0|-3.71|8.7|||Mixed Models Analysis|||||8.70|-3.71|0.429
70911655|NCT02696785|141313286|SUPERIORITY||LSMean Difference|-5.47|STANDARD_ERROR_OF_MEAN|3.27||0.096|TWO_SIDED|95.0|-11.92|0.98|||Mixed Models Analysis|||||0.98|-11.92|0.096
70911656|NCT02696785|141313290|SUPERIORITY||LSMean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.76||0.166|TWO_SIDED|95.0|-2.6|0.4|||Mixed Models Analysis|||||0.4|-2.6|0.166
70911657|NCT02696785|141313290|SUPERIORITY||LSMean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.73||0.011|TWO_SIDED|95.0|-3.4|-0.4|||Mixed Models Analysis|||||-0.4|-3.4|0.011
70911658|NCT02696785|141313290|SUPERIORITY||LSMean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.77||0.182|TWO_SIDED|95.0|-2.6|0.5|||Mixed Models Analysis|||||0.5|-2.6|0.182
70911659|NCT02696785|141313291|SUPERIORITY||LSMean Difference|-10.07|STANDARD_ERROR_OF_MEAN|1.588|<|0.001|TWO_SIDED|95.0|-13.2|-6.9|||ANCOVA|||||-6.9|-13.2|<0.001
70911660|NCT02696785|141313291|SUPERIORITY||LSMean Difference|-9.51|STANDARD_ERROR_OF_MEAN|1.591|<|0.001|TWO_SIDED|95.0|-12.6|-6.4|||ANCOVA|||||-6.4|-12.6|<0.001
70911661|NCT02696785|141313291|SUPERIORITY||LSMean Difference|-8.08|STANDARD_ERROR_OF_MEAN|1.603|<|0.001|TWO_SIDED|95.0|-11.2|-4.9|||ANCOVA|||||-4.9|-11.2|<0.001
70911662|NCT04863898|141313292|SUPERIORITY||Mean Difference (Net)|-6.1|||||TWO_SIDED|95.0|-7.0|-5.2|||||LME regression, random intercepts by individual and fixed effects of participant characteristics. Difference = endline - baseline.|Using the PASS software program, we estimated the power for comparisons of scores from pre- to post-intervention, assuming a p-value of 0.05 (two-sided) and a final sample size of 131 with both measurements. We would have 85% power to detect a small-to-medium sized effect based on standardized mean difference (d=0.32).||-5.2|-7|
70911663|NCT04863898|141313296|SUPERIORITY||Mean Difference (Net)|0.97|||||TWO_SIDED|95.0|0.86|1.09|||||Calculated using a linear mixed effect regression model with random intercepts by individual Difference = endline - baseline.|Using the PASS software program, we estimated the power for comparisons of scores from pre- to post-intervention, assuming a p-value of 0.05 (two-sided) and a final sample size of 131 with both measurements. We would have 85% power to detect a small-to-medium sized effect based on standardized mean difference (d=0.32).||1.09|0.86|
70911664|NCT04863898|141313297|SUPERIORITY||Mean Difference (Net)|-4.2|||||TWO_SIDED|95.0|-4.7|-3.6|||||LME regression, random intercepts by individual and fixed effects of participant characteristics. Difference = endline - baseline.|Using the PASS software program, we estimated the power for comparisons of scores from pre- to post-intervention, assuming a p-value of 0.05 (two-sided) and a final sample size of 131 with both measurements. We would have 85% power to detect a small-to-medium sized effect based on standardized mean difference (d=0.32).||-3.6|-4.7|
70911665|NCT00770211|141313298|SUPERIORITY_OR_OTHER||Difference response rate|0.48|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|0.4|0.56|||Fisher Exact|||The efficacy of the treatment was confirmed, if H0 was rejected at a given alpha of 5%, that means if the two sided p-value is ≤ 0.05. Power of 90%||0.56|0.40|<0.0001
70911666|NCT01822821|141313304|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was tested using a noninferiority margin of 1.15.|ratio of geometric means|0.89||||0.08|ONE_SIDED|90.0||1.06|||Regression, Linear||Ratio of geometric means (CI) for IV acetaminophen versus placebo was estimated as the exponentiated treatment effect parameter from a multivariable linear regression model on log opioid consumption adjusting for age and diabetes.|||1.06||0.08
70911667|NCT01822821|141313304|SUPERIORITY_OR_OTHER||ratio of geometric means|0.89||||0.28|ONE_SIDED|95.0||1.1|||Regression, Linear||Ratio of geometric means (CI) for IV acetaminophen versus placebo was estimated as the exponentiated treatment effect parameter from a multivariable linear regression model on log opioid consumption adjusting for age and diabetes.|||1.10||0.28
70911668|NCT01822821|141313305|NON_INFERIORITY_OR_EQUIVALENCE|We assessed whether IV acetaminophen is noninferior to placebo using a noninferiority margin of 1.0.|Median Difference (Final Values)|-0.9|||<|0.001|ONE_SIDED|90.0||-0.5|||Regression, Linear||Difference in overall postoperative pain score means based on a repeated measures linear regression model with an autoregressive correlation structure, adjusting for age, time, and diabetes.|||-0.5||< 0.001
70911669|NCT01822821|141313305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||<|0.001|ONE_SIDED|95.0||-0.42|||Regression, Linear||Difference in overall postoperative pain score means based on a repeated measures linear regression model with an autoregressive correlation structure, adjusting for age, time, and diabetes.|||-0.42||< 0.001
70911670|NCT01822821|141313306|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.76||||0.35|TWO_SIDED|99.4|0.34|1.7|||Regression, Logistic||Relative risk of PONV in IV acetaminophen versus placebo patients estimated from a multivariable logistic regression model using the log link and adjusting for age and diabetes.|||1.7|0.34|0.35
70911671|NCT01822821|141313307|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.13|TWO_SIDED|99.8|0.0|0.0|||Wilcoxon (Mann-Whitney)||Difference in medians of IV acetaminophen versus placebo patients based on Wilcoxon rank sum test and Hodges-Lehmann estimation of location shift.|Analysis at 8 hours after surgery.||0|0|0.13
70911672|NCT01822821|141313307|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.44|TWO_SIDED|99.8|0.0|0.0|||Wilcoxon (Mann-Whitney)||Difference in medians of IV acetaminophen versus placebo patients based on Wilcoxon rank sum test and Hodges-Lehmann estimation of location shift.|Analysis at 16 hours after surgery.||0|0|0.44
70911673|NCT01822821|141313307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.38|TWO_SIDED|99.8|0.0|0.0|||Wilcoxon (Mann-Whitney)||Difference in medians of IV acetaminophen versus placebo patients based on Wilcoxon rank sum test and Hodges-Lehmann estimation of location shift.|Analysis at 24 hours after surgery||0|0|0.38
70911674|NCT01822821|141313308|SUPERIORITY_OR_OTHER||ratio of geometric means|1.3||||0.46|TWO_SIDED|99.4|0.52|3.2|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on duration of mechanical ventilation was assessed by use of the ratio of geometric means from a multivariable logistic regression models adjusting for age and diabetes.|||3.20|0.52|0.46
70911675|NCT01822821|141313309|SUPERIORITY_OR_OTHER||ratio of geometric means|0.93||||0.38|TWO_SIDED|99.4|0.74|1.2|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on duration of ICU stay was assessed by use of the ratio of geometric means from a multivariable logistic regression models adjusting for age and diabetes.|||1.20|0.74|0.38
70911676|NCT01822821|141313310|SUPERIORITY_OR_OTHER||ratio of geometric means|1.1||||0.12|TWO_SIDED|99.4|0.94|1.2|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on duration of mechanical ventilation was assessed by use of the ratio of geometric means from a multivariable logistic regression models adjusting for age and diabetes.|||1.20|0.94|0.12
70911677|NCT01822821|141313311|SUPERIORITY_OR_OTHER||ratio of geometric means|1.1||||0.31|TWO_SIDED|99.4|0.9|1.2|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on ALT was assessed by use of the ratio of geometric means from a repeated measures multivariable logistic regression models adjusting for age and diabetes.|||1.2|0.9|0.31
70911678|NCT01822821|141313312|SUPERIORITY_OR_OTHER||ratio of geometric means|1.0||||0.98|TWO_SIDED|99.4|0.8|1.2|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on AST was assessed by use of the ratio of geometric means from a repeated measures multivariable logistic regression models adjusting for age and diabetes.|||1.2|0.8|0.98
70911679|NCT01822821|141313313|SUPERIORITY_OR_OTHER||ratio of geometric means|1.1||||0.4|TWO_SIDED|99.4|0.87|1.3|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on bilirubin was assessed by use of the ratio of geometric means from a repeated measures multivariable logistic regression models adjusting for age and diabetes.|||1.3|0.87|0.40
70911680|NCT00764868|141313316|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 2 sided|t-test of LDX at baseline and 52 weeks||||||<0.001
70911681|NCT00764868|141313318|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 2 sided|t-test of LDX at baseline and 52 weeks||||||<0.001
70911682|NCT03005288|141313321|SUPERIORITY||Mean Difference (Net)|-7.31|||<|0.001|TWO_SIDED|80.0|-8.48|-6.14|||Mixed-Effect Model Repeated Measure|||||-6.14|-8.48|<0.001
70911683|NCT03005288|141313322|SUPERIORITY||Mean Difference (Net)|-5.19|||<|0.001|TWO_SIDED|80.0|-6.01|-4.37|||Mixed-Effect Model Repeated Measure|||||-4.37|-6.01|<0.001
70911684|NCT03005288|141313323|SUPERIORITY||Mean Difference (Net)|-1.13|||<|0.001|TWO_SIDED|80.0|-1.42|-0.83|||Mixed Models Analysis|||week 24||-0.83|-1.42|<0.001
70911685|NCT03005288|141313323|SUPERIORITY||Mean Difference (Net)|-0.8||||0.005|TWO_SIDED|80.0|-1.2|-0.41|||Mixed Models Analysis|||week 48||-0.41|-1.20|0.005
70911686|NCT03005288|141313327|SUPERIORITY||Mean Difference (Net)|-1.33|||<|0.001|TWO_SIDED|80.0|-1.71|-0.95|||Mixed-Effect Model Repeated Measure|||week 24||-0.95|-1.71|<0.001
70911687|NCT03005288|141313327|SUPERIORITY||Mean Difference (Net)|-1.91|||<|0.001|TWO_SIDED|80.0|-2.48|-1.34|||Mixed-Effect Model Repeated Measure|||week 48||-1.34|-2.48|<0.001
70911688|NCT03005288|141313328|SUPERIORITY||Mean Difference (Net)|-3.43|||<|0.001|TWO_SIDED|80.0|-4.54|-2.31|||Mixed-Effect Model Repeated Measure|||week 24||-2.31|-4.54|<0.001
70911689|NCT03005288|141313328|SUPERIORITY||Mean Difference (Net)|-5.1|||<|0.001|TWO_SIDED|80.0|-6.74|-3.47|||Mixed-Effect Model Repeated Measure|||week 48||-3.47|-6.74|<0.001
70911690|NCT03005288|141313329|SUPERIORITY||Mean Difference (Net)|1.49||||0.003|TWO_SIDED|80.0|0.82|2.06|||Mixed-Effect Model Repeated Measure|||week 24||2.06|0.82|0.003
70911691|NCT03005288|141313329|SUPERIORITY||Mean Difference (Net)|2.14|||<|0.001|TWO_SIDED|80.0|1.36|2.93|||Mixed-Effect Model Repeated Measure|||week 48||2.93|1.36|<0.001
70911692|NCT03005288|141313330|SUPERIORITY||Mean Difference (Net)|-4.09|||<|0.001|TWO_SIDED|80.0|-5.26|-2.92|||Mixed-Effect Model Repeated Measure|||week 24||-2.92|-5.26|<0.001
70911693|NCT03005288|141313330|SUPERIORITY||Mean Difference (Net)|-9.46|||<|0.001|TWO_SIDED|80.0|-11.3|-7.64|||Mixed-Effect Model Repeated Measure|||week 52||-7.64|-11.3|<0.001
70911694|NCT03005288|141313331|SUPERIORITY||Mean Difference (Net)|-0.02||||0.062|TWO_SIDED|80.0|-0.03|0.0|||Mixed-Effect Model Repeated Measure|||week 24||-0.00|-0.03|0.062
70911695|NCT03005288|141313331|SUPERIORITY||Mean Difference (Net)|-0.06|||<|0.001|TWO_SIDED|80.0|-0.08|-0.04|||Mixed-Effect Model Repeated Measure|||week 52||-0.04|-0.08|<0.001
70911696|NCT03005288|141313332|SUPERIORITY||Mean Difference (Net)|-0.65||||0.028|TWO_SIDED|80.0|-1.03|-0.28|||Mixed-Effect Model Repeated Measure|||week 12||-0.28|-1.03|0.028
70911697|NCT03005288|141313332|SUPERIORITY||Mean Difference (Net)|-0.66||||0.081|TWO_SIDED|80.0|-1.14|-0.18|||Mixed-Effect Model Repeated Measure|||week 36||-0.18|-1.14|0.081
70911698|NCT03824236|141313334|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people (P-Fx Group) compared to unvaccinated people (Infectivity Control Group).|Vaccine efficacy rate|52.0||||0.003|TWO_SIDED|95.0|28.0|68.0|||Fisher Exact|||Efficacy analysis aimed at comparing P. falciparum parasitemia incidence after sporozoite challenge between P-Fx group and the Infectivity Control group.||68|28|0.003
70911699|NCT03824236|141313334|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people (NP-Fx Group) compared to unvaccinated people (Infectivity Control Group).|Vaccine efficacy rate|54.0||||0.002|TWO_SIDED|95.0|29.0|70.0|||Fisher Exact|||Efficacy analysis aimed at comparing P. falciparum parasitemia incidence after sporozoite challenge between NP-Fx group and the Infectivity Control group.||70|29|0.002
70911700|NCT02857283|141313374|SUPERIORITY|||||||0.46|||||||ANOVA|paired||||||0.46
70911701|NCT02857283|141313375|SUPERIORITY|||||||0.0481|||||||ANOVA|Paired||||||0.0481
70911702|NCT02857283|141313376|SUPERIORITY|||||||0.0179|||||||ANOVA|||||||0.0179
70911703|NCT02857283|141313377|SUPERIORITY|||||||0.1|||||||ANOVA|paired||||||0.10
70911704|NCT02857283|141313378|SUPERIORITY|||||||0.69|||||||ANOVA|paired||||||0.69
70911705|NCT02857283|141313379|SUPERIORITY|||||||0.27|||||||ANOVA|paired||||||0.27
70911706|NCT02857283|141313380|SUPERIORITY|||||||0.5|||||||ANOVA|paired||||||0.50
70911707|NCT02857283|141313381|SUPERIORITY|||||||0.54|||||||Wilcoxon signed rank test|||||||0.54
70911708|NCT02857283|141313382|SUPERIORITY|||||||0.9|||||||ANOVA|paired||||||0.90
70911709|NCT02857283|141313384|SUPERIORITY|||||||0.64|||||||Wilcoxon signed rank test|||||||0.64
70911710|NCT02857283|141313385|SUPERIORITY|||||||0.79|||||||Wilcoxon signed rank test|||||||0.79
70911711|NCT02857283|141313386|SUPERIORITY|||||||0.094|||||||ANOVA|||||||0.094
70911712|NCT01207908|141313387|SUPERIORITY||Mean Difference (Final Values)|-8.5||||0.53|TWO_SIDED|95.0|-37.1|20.1|||t-test, 2 sided|||||20.1|-37.1|0.53
70911713|NCT01207908|141313388|SUPERIORITY||Mean Difference (Final Values)|-2.66|||<|0.0001|TWO_SIDED|95.0|-3.78|-1.55|||t-test, 2 sided|||||-1.55|-3.78|<0.0001
70911714|NCT01207908|141313389|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.53|TWO_SIDED|95.0|-1.26|2.38|||t-test, 2 sided|||||2.38|-1.26|0.53
70911715|NCT05074498|141313430|OTHER||Least square mean difference|-0.35||||0.0838|TWO_SIDED|95.0|-0.741|0.047|||Mixed Models Analysis|||||0.047|-0.741|0.0838
70911716|NCT02967016|141313470|OTHER|||||||0.002|||||||Kruskal-Wallis|||Cumulative Steps 6 h||||0.002
70911717|NCT02967016|141313470|OTHER|||||||0.0002|||||||Kruskal-Wallis|||Cumulative steps 12 h||||.0002
70911718|NCT02967016|141313470|OTHER|||||||0.0006|||||||Kruskal-Wallis|||Cumulative steps 24 h||||.0006
70911719|NCT02967016|141313470|OTHER|||||||0.0006|||||||Kruskal-Wallis|||Cumulative steps 36 h||||0.0006
70911720|NCT02967016|141313470|OTHER|||||||0.03|||||||Kruskal-Wallis|||Cumulative steps 48 h||||0.03
70911721|NCT02967016|141313471|OTHER|||||||0.06|||||||Kruskal-Wallis|||Pain at rest 6 h||||0.06
70911722|NCT02967016|141313471|OTHER|||||||0.3|||||||Kruskal-Wallis|||Pain at rest 12 h||||.30
70911723|NCT02967016|141313471|OTHER|||||||0.002|||||||Kruskal-Wallis|||Pain at rest 24 h||||.002
70911724|NCT02967016|141313471|OTHER|||||||0.003|||||||Kruskal-Wallis|||Pain at rest 36 h||||0.003
70911725|NCT02967016|141313471|OTHER|||||||0.02|||||||Kruskal-Wallis|||Pain at rest at 48 h||||.02
70911726|NCT02967016|141313472|OTHER|||||||0.43|||||||Kruskal-Wallis|||Satisfaction with pain control 6 h||||.43
70911727|NCT02967016|141313472|OTHER|||||||0.24|||||||Kruskal-Wallis|||Satisfaction with pain control 12 h||||.24
70911728|NCT02967016|141313472|OTHER|||||||0.012|||||||Kruskal-Wallis|||Satisfaction with pain control 24 h||||.012
70911729|NCT02967016|141313472|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||Satisfaction with pain control 36 h||||<0.0001
70911730|NCT02967016|141313472|OTHER|||||||0.0005|||||||Kruskal-Wallis|||Satisfaction with pain control 48 h||||.0005
70911731|NCT04541186|141313505|SUPERIORITY||Median Percent Change Difference|-43.73|||<|0.001|TWO_SIDED|95.0|-57.08|-30.31||Significant level = 0.05|van Elteren test|Nonparametric analysis stratified by baseline TG level and background lipid therapy to test the treatment difference using pooled data.|The location shift and Hodges-Lehmann 95% confidence interval were based on Hodges-Lehman estimation. Placebo group is the reference group, and the comparison was performed in pooled pegozafermin treatment group vs. placebo pooled.|||-30.31|-57.08|<0.001
70911732|NCT04541186|141313506|SUPERIORITY||||||<|0.001||||||Significant level = 0.05|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by baseline TG level and lipid modifying therapy use.||||||<0.001
70911733|NCT04541186|141313507|SUPERIORITY||Least Squares Means Difference|-17.87|STANDARD_ERROR_OF_MEAN|6.425||0.007|TWO_SIDED|95.0|-30.67|-5.07||Significant level = 0.05|MMRM|||MMRM analysis of non-HDL-C comparison between pegozafermin pooled versus placebo pooled group.||-5.07|-30.67|0.007
70911734|NCT04541186|141313507|SUPERIORITY||Least Squares Means Difference|-11.75|STANDARD_ERROR_OF_MEAN|4.888||0.019|TWO_SIDED|95.0|-21.48|-2.01||Significant level of 0.05|MMRM|||MMRM analysis of ApoB comparison between pegozafermin pooled versus placebo pooled group.||-2.01|-21.48|0.019
70911735|NCT04541186|141313507|SUPERIORITY||Least Squares Means Difference|1.73|STANDARD_ERROR_OF_MEAN|10.519||0.87|TWO_SIDED|95.0|-19.21|22.68||Significant level = 0.05|MMRM|||MMRM analysis of LDL-C comparison between pegozafermin pooled versus placebo pooled group.||22.68|-19.21|0.870
70911736|NCT04541186|141313507|SUPERIORITY||Least Squares Means Difference|15.41|STANDARD_ERROR_OF_MEAN|8.182||0.064|TWO_SIDED|95.0|-0.89|31.7||Significant level = 0.05|MMRM|||MMRM analysis of HDL-C comparison between pegozafermin pooled versus placebo pooled group.||31.70|-0.89|0.064
70911737|NCT04541186|141313508|SUPERIORITY|||||||0.006||||||Significant level = 0.05|van Elteren Test|||Nonparametric analysis of VLDL-C comparison between pegozafermin pooled versus placebo pooled group.||||0.006
70911738|NCT04541186|141313508|SUPERIORITY|||||||0.002||||||Significant level of 0.05|van Elteren test|||Nonparametric analysis of VLDL-TG comparison between pegozafermin pooled versus placebo pooled group.||||0.002
70911739|NCT04541186|141313509|SUPERIORITY|||||||0.809||||||Significant level = 0.05|MMRM|||MMRM analysis of fasting plasma glucose comparison between pegozafermin pooled versus placebo pooled group.||||0.809
70911740|NCT04541186|141313509|SUPERIORITY||||||<|0.001||||||Significant level = 0.05|MMRM|||MMRM analysis of adiponectin comparison between pegozafermin pooled versus placebo pooled group.||||<0.001
70911741|NCT04541186|141313509|SUPERIORITY|||||||0.973||||||Significant level = 0.05|MMRM|||MMRM analysis of body weight comparison between pegozafermin pooled versus placebo pooled group.||||0.973
70911742|NCT04541186|141313510|SUPERIORITY|||||||0.012||||||Significant level = 0.05|ANCOVA|||||||0.012
70911743|NCT00058058|141313533|OTHER|Estimation of diagnostic yield|Binomial proportion|0.031|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.02|0.042||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 0, 4 or 5 based on Final BI-RADS||0.042|0.020|
71092602|NCT02178956|141691574|SUPERIORITY||Odds Ratio (OR)|0.93||||0.7359|TWO_SIDED|95.0|0.6|1.44||2-sided|Cochran-Mantel-Haenszel|Based on CMH test stratified by actual stratification variables at baseline including region, and time to progression on first-line therapy.|Odds ratio for napabucasin vs. Placebo. Based on Logistic Regression Model adjusting for actual Stratification variables at baseline including region, and time to progression on first-line therapy.|||1.44|0.60|0.7359
70911744|NCT00058058|141313533|OTHER||Binomial Proportion|0.031|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.021|0.044||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 4 or 5 based on initial MRI and subsequent work-up||0.044|0.021|
70911745|NCT00058058|141313533|OTHER||Binomial Proportion|0.031|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.02|0.042||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 4 or 5 based on initial MRI and subsequent work-up and a completed biopsy procedure||0.042|0.020|
70911746|NCT00058058|141313533|OTHER||Binomial proportion|0.031|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.02|0.042||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 0, 4 or 5 on the initial MRI scan||0.042|0.020|
70911747|NCT00058058|141313533|OTHER||Binomial Proportion|0.032|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.021|0.043||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 0, 3, 4 or 5 on the initial MRI scan||0.043|0.021|
70911748|NCT00058058|141313533|OTHER||Binomial Proportion|0.032|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.021|0.043||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 0, 3, 4 or 5 based on initial MRI and subsequent work-up||0.043|0.021|
70911749|NCT00058058|141313534|OTHER||Binomial Proportion|0.9091|STANDARD_ERROR_OF_MEAN|0.05004|||TWO_SIDED|95.0|0.7567|0.9809||||||"Sensitivity estimate - estimates the P(T+\|D+) where the MRI within 90 days of a negative mammogram is the test (T) and cancer in the contralateral breast is the Disease status(D)"||0.9809|0.7567|
70911750|NCT00058058|141313534|OTHER||Binomial Proportion|0.8782|STANDARD_ERROR_OF_MEAN|0.0107|||TWO_SIDED|95.0|0.8555|0.8985||||||"Specificity - estimates the P(T-\|D-) of MRI where the MRI within 90 days of a negative mammogram is the test (T) and cancer in the contralateral breast is the Disease status(D)"||0.8985|0.8555|
71092603|NCT02178956|141691575|SUPERIORITY||Odds Ratio (OR)|0.93||||0.6555|TWO_SIDED|95.0|0.66|1.3||2-sided|Cochran-Mantel-Haenszel|Based on CMH test stratified by actual stratification variables at baseline including region, and time to progression on first-line therapy.|Odds ratio for napabucasin vs. Placebo. Based on Logistic Regression Model adjusting for actual Stratification variables at baseline including region, and time to progression on first-line therapy.|||1.30|0.66|0.6555
71092604|NCT03769493|141691592|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||< .001
71092605|NCT03769493|141691593|SUPERIORITY|||||||0.875|||||||t-test, 2 sided|||||||.875
70911751|NCT00058058|141313534|OTHER||Binomial Proportion|0.2083|STANDARD_ERROR_OF_MEAN|0.0338|||TWO_SIDED|95.0|0.1452|0.2839||||||"PPV estimate - estimates the P(D+\|T+), where the MRI within 90 days of a negative mammogram is the test (T) and cancer in the contralateral breast is the Disease status(D)."||0.2839|0.1452|
70911752|NCT00058058|141313534|OTHER||Binomial Proportion|0.9964|STANDARD_ERROR_OF_MEAN|0.0021|||TWO_SIDED|95.0|0.9894|0.9993||||||"B. NPV Analysis for ALL Cases in Analysis Set NPV estimate - estimates the P(D-\|T-), where the MRI within 90 days of a negative mammogram is the test (T) and cancer in the contralateral breast is the Disease status(D)"||0.9993|0.9894|
71092606|NCT01900314|141691631|SUPERIORITY_OR_OTHER|||||||0.16|||||||ANCOVA|||Repeated measures ANCOVA at 4 weeks with baseline MADRS as co-variate||||0.16
71092607|NCT01900314|141691632|SUPERIORITY_OR_OTHER|||||||0.04|||||||ANCOVA|||Repeated measures ANCOVA with baseline MADRS as co-variate||||0.04
71092608|NCT01104766|141691635|SUPERIORITY||Mean Difference (Final Values)|-6.0||||0.0044|TWO_SIDED|95.0|-10.1|-1.9|||ANCOVA|||||-1.9|-10.1|0.0044
70911753|NCT00058058|141313534|OTHER||Binomial Proportion|0.031|STANDARD_ERROR_OF_MEAN|0.00556|||TWO_SIDED|95.0|0.021|0.044||||||B. Diagnostic Yield for ALL Cases in Analysis Set Diagnostic Yield - estimates the likelihood that the MRI within 90 days of a negative mammogram will provide the information needed to establish a diagnosis||0.044|0.021|
71092609|NCT01104766|141691635|SUPERIORITY||Mean Difference (Final Values)|-8.8|||<|0.0001|TWO_SIDED|95.0|-12.9|-4.7|||ANCOVA|||||-4.7|-12.9|<0.0001
71092610|NCT01104766|141691635|SUPERIORITY||Median Difference (Final Values)|-7.0||||0.0008|TWO_SIDED|95.0|-11.0|-2.9|||ANCOVA|||||-2.9|-11.0|0.0008
71092611|NCT01104766|141691636|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.0004|TWO_SIDED|95.0|-0.6|-0.2|||ANCOVA|||||-0.2|-0.6|0.0004
71092612|NCT01104766|141691636|SUPERIORITY||Median Difference (Final Values)|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.3|||ANCOVA|||||-0.3|-0.7|<0.0001
71092613|NCT01104766|141691636|SUPERIORITY||Median Difference (Final Values)|-0.4||||0.0001|TWO_SIDED|95.0|-0.6|-0.2|||ANCOVA|||||-0.2|-0.6|0.0001
71092614|NCT04225832|141691646|SUPERIORITY||Odds Ratio (OR)|2.51||||0.049|TWO_SIDED|95.0|1.01|6.26||a-priori threshold was p\<.05 for two-sided p-value Regression employed nonresponse weights to account for any bias associated with completing any follow-up survey.|Regression, Logistic|Regression results control for immigration status and length of time in U.S.|Odds ratio is for indicator of intervention arm||Regression results control for immigration status and length of time in U.S.|6.26|1.01|.049
71092615|NCT04225832|141691647|SUPERIORITY||Odds Ratio (OR)|1.06||||0.83|TWO_SIDED|95.0|0.62|1.81||a-priori threshold was p\<.05 for two-sided p-value Regression employed nonresponse weights to account for any bias associated with completing any follow-up survey.|Regression, Logistic|Regression results control for immigration status and length of time in U.S.|Odds ratio is for indicator of intervention arm|||1.81|0.62|.83
71092616|NCT04225832|141691648|SUPERIORITY||Slope|0.14|STANDARD_ERROR_OF_MEAN|0.09||0.14|TWO_SIDED|||||a-priori threshold was p\<.05 for two-sided p-value Regression employed nonresponse weights to account for any bias associated with completing any follow-up survey.|Regression, Linear|Regression results control for immigration status, length of time in U.S., and baseline value of the outcome|Slope is adjusted regression coefficient for indicator of intervention arm|"Unlike the observed at any FU primary outcomes which have a single value for each participant, for this outcome we employed a repeated measures style structure with one record for each of up to 3 FU observations. A sandwich estimator (SAS Proc Surveyreg) was employed to account for clustering of observations within participant."||||.14
70911754|NCT00058058|141313535|OTHER||ROC analysis|0.9355|||||TWO_SIDED|95.0|0.8956|0.9753|||||exact CI|ROC analysis - estimates the accuracy of MRI within 90 days of a negative mammogram to detect cancer in the contralateral breast||0.9753|0.8956|
70911755|NCT00790062|141313558|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.67|TWO_SIDED|95.0|0.63|1.59|||ANCOVA|||||1.59|0.63|0.670
70911756|NCT03432533|141313581|NON_INFERIORITY|Conclusions for the primary efficacy hypothesis of efficacy of self-administration of romosozumab by AI/Pen compared with HCP-administered romosozumab by PFS at lumbar spine BMD at Month 6 was made using a 1-sided test with type 1 error rate of 0.025 and noninferiority margin of -2.0%.|LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.6||0.84|TWO_SIDED|95.0|-1.3|1.0|||ANCOVA|||||1.0|-1.3|0.84
70911757|NCT01454362|141313609|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
70911758|NCT01454362|141313610|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||||||0.43
70911759|NCT01454362|141313611|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70911760|NCT01454362|141313612|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
70911761|NCT01454362|141313613|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
70911762|NCT01119703|141313623|SUPERIORITY_OR_OTHER||Coefficient of Determination %|-9.1|||||TWO_SIDED|95.0|-13.8|-0.7|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all baseline biomarkers as predictors.||-0.7|-13.8|
70911763|NCT01119703|141313624|SUPERIORITY_OR_OTHER||Coefficient of Determination %|17.6|||||TWO_SIDED|95.0|10.6|20.9|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all baseline biomarkers as predictors.||20.9|10.6|
70911764|NCT01119703|141313625|SUPERIORITY_OR_OTHER||Coefficient of Determination %|27.8|||||TWO_SIDED|95.0|19.6|32.4|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all baseline biomarkers as predictors.||32.4|19.6|
70911765|NCT01119703|141313626|SUPERIORITY_OR_OTHER||Coefficient of Determination %|3.3||||||95.0|-2.8|8.5|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all baseline biomarkers as predictors.||8.5|-2.8|
70911766|NCT01119703|141313627|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|-0.04||||0.66|TWO_SIDED|95.0|-0.2|0.13|||Fisher's Z-transformation||Within-participant rank correlation|Diphtheria versus Hepatitis B||0.13|-0.2|0.66
70911767|NCT01119703|141313627|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|0.1||||0.26|TWO_SIDED|95.0|-0.07|0.25|||Fisher's Z-transformation||Within-participant rank correlation|Diphtheria versus Cholera||0.25|-0.07|0.26
70911768|NCT01119703|141313627|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|0.4|||<|0.001|TWO_SIDED|95.0|0.26|0.53|||Fisher's Z-transformation||Within-participant rank correlation|Diphtheria versus Tetanus||0.53|0.26|<0.001
70911769|NCT01119703|141313627|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|-0.17||||0.04|TWO_SIDED|95.0|-0.32|-0.01|||Fisher's Z-transformation||Within-participant rank correlation|Hepatitis B versus Cholera||-0.01|-0.32|0.04
70911770|NCT01119703|141313627|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|-0.09||||0.3|TWO_SIDED|95.0|-0.25|0.08|||Fisher's Z-transformation||Within-participant rank correlation|Hepatitis B versus Tetanus||0.08|-0.25|0.30
70911771|NCT01119703|141313627|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|0.08||||0.36|TWO_SIDED|95.0|-0.09|0.24|||Fisher's Z-transformation||Within-participant rank correlation|Cholera versus Tetanus||0.24|-0.09|0.36
70911772|NCT01119703|141313628|SUPERIORITY_OR_OTHER||Coefficient of Determination %|-9.5|||||TWO_SIDED|95.0|-16.6|-2.7|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all Day 7 biomarkers as predictors.||-2.7|-16.6|
70911773|NCT01119703|141313629|SUPERIORITY_OR_OTHER||Coefficient of Determination %|23.7|||||TWO_SIDED|95.0|14.0|29.7|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all Day 7 biomarkers as predictors.||29.7|14.0|
70911774|NCT01119703|141313630|SUPERIORITY_OR_OTHER||Coefficient of Determination %|36.7|||||TWO_SIDED|95.0|28.7|41.5|||||Crossvalidated;negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all Day 7 biomarkers as predictors.||41.5|28.7|
70970607|NCT00531752|141447058|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.8639|STANDARD_ERROR_OF_MEAN|2.2354||0.0334|TWO_SIDED|80.0|-7.759|-1.968|||Mixed Models Analysis|||Week 3 (General well-being): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.968|-7.759|0.0334
70911775|NCT01119703|141313631|SUPERIORITY_OR_OTHER||Coefficient of Determination %|-2.2|||||TWO_SIDED|95.0|-7.8|4.4|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all Day 7 biomarkers as predictors.||4.4|-7.8|
70911776|NCT01112735|141313648|SUPERIORITY|||||||0.5621|||||||Wilcoxon (Mann-Whitney)|||||||0.5621
70911777|NCT01112735|141313649|SUPERIORITY|||||||0.3595|||||||Wilcoxon (Mann-Whitney)|||||||0.3595
70911778|NCT01112735|141313650|SUPERIORITY|||||||0.9417|||||||Wilcoxon (Mann-Whitney)|||Day 3||||0.9417
70911779|NCT01112735|141313650|SUPERIORITY|||||||0.5488|||||||Wilcoxon (Mann-Whitney)|||Day 7||||0.5488
70911780|NCT01112735|141313650|SUPERIORITY|||||||0.7107|||||||Wilcoxon (Mann-Whitney)|||Day 14||||0.7107
70911781|NCT01112735|141313650|SUPERIORITY|||||||0.8809|||||||Wilcoxon (Mann-Whitney)|||Day 28||||0.8809
70911782|NCT01112735|141313650|SUPERIORITY|||||||0.4598|||||||Wilcoxon (Mann-Whitney)|||Day 60||||0.4598
70911783|NCT01112735|141313650|SUPERIORITY|||||||0.3837|||||||Wilcoxon (Mann-Whitney)|||Day 90||||0.3837
70911784|NCT01112735|141313651|SUPERIORITY|||||||0.9699|||||||Wilcoxon (Mann-Whitney)|||Day 3||||0.9699
70911785|NCT01112735|141313651|SUPERIORITY|||||||0.4709|||||||Wilcoxon (Mann-Whitney)|||Day 7||||0.4709
70911786|NCT01112735|141313651|SUPERIORITY|||||||0.1406|||||||Wilcoxon (Mann-Whitney)|||Day 14||||0.1406
70911787|NCT01112735|141313651|SUPERIORITY|||||||0.4291|||||||Wilcoxon (Mann-Whitney)|||Day 28||||0.4291
70911788|NCT01112735|141313651|SUPERIORITY|||||||0.2704|||||||Wilcoxon (Mann-Whitney)|||Day 60||||0.2704
70911789|NCT01112735|141313651|SUPERIORITY|||||||0.7564|||||||Wilcoxon (Mann-Whitney)|||Day 90||||0.7564
70911790|NCT00916006|141313654|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
70911791|NCT00916006|141313655|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
70911792|NCT01222247|141313662|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.8||||0.02|TWO_SIDED|95.0|0.66|0.97|||Chi-squared|||Analysis for Primary Outcome composite||0.97|0.66|0.02
70911793|NCT01222247|141313662|SUPERIORITY||Risk Ratio (RR)|0.77||||0.01|TWO_SIDED|95.0|0.63|0.95|||Chi-squared|||Analysis for CPAP or high-flow nasal cannula||0.95|0.63|0.01
70911794|NCT01222247|141313662|SUPERIORITY||Risk Ratio (RR)|0.77||||0.17|TWO_SIDED|95.0|0.53|1.12|||Chi-squared|||Analysis for Fraction of inspired oxygen||1.12|0.53|0.17
70911795|NCT01222247|141313662|SUPERIORITY||Risk Ratio (RR)|0.78||||0.26|TWO_SIDED|95.0|0.5|1.21|||Chi-squared|||Analysis for mechanical ventilation||1.21|0.50|0.26
70911796|NCT01222247|141313663|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.67|||<|0.001|TWO_SIDED|95.0|0.53|0.84|||Chi-squared|||||0.84|0.53|<0.001
70911797|NCT01222247|141313664|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.78||||0.003|TWO_SIDED|95.0|0.66|0.92|||Chi-squared|||||0.92|0.66|0.003
70911798|NCT01222247|141313665|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.87||||0.36|TWO_SIDED|95.0|0.65|1.17|||Chi-squared|||||1.17|0.65|0.36
70911799|NCT01222247|141313666|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.68||||0.002|TWO_SIDED|95.0|0.53|0.87|||Chi-squared|||||0.87|0.53|0.002
70911800|NCT01222247|141313667|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.88||||0.57|TWO_SIDED|95.0|0.55|1.39|||Chi-squared|||||1.39|0.55|0.57
70911801|NCT01222247|141313668|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.22||||0.04|TWO_SIDED|95.0|0.02|0.92|||Chi-squared|||||0.92|0.02|0.04
70911802|NCT01222247|141313669|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.45||||0.1|TWO_SIDED|95.0|0.17|1.19|||Chi-squared|||||1.19|0.17|0.10
70911803|NCT01222247|141313670|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.59||||0.03|TWO_SIDED|95.0|0.37|0.96|||Chi-squared|||||0.96|0.37|0.03
70911804|NCT01222247|141313671|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.78||||0.004|TWO_SIDED|95.0|0.66|0.93|||Chi-squared|||||0.93|0.66|0.004
70911805|NCT01222247|141313672|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.82||||0.74|TWO_SIDED|95.0|0.25|2.68|||Chi-squared|||||2.68|0.25|0.74
70911806|NCT01222247|141313673|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Chi-squared|||||||0.50
70911807|NCT01222247|141313674|SUPERIORITY_OR_OTHER_LEGACY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
70911808|NCT01222247|141313675|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.14||||0.13|TWO_SIDED|95.0|0.96|1.34|||Chi-squared|||||1.34|0.96|0.13
70911809|NCT01222247|141313676|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1|||||||Chi-squared|||||||0.10
70911810|NCT01222247|141313678|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.8||||0.62|TWO_SIDED|95.0|0.33|1.93|||Chi-squared|||||1.93|0.33|0.62
70911811|NCT01222247|141313680|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.88||||0.4|TWO_SIDED|95.0|0.66|1.18|||Chi-squared|||||1.18|0.66|0.40
70911812|NCT01222247|141313681|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.6|||<|0.001|TWO_SIDED|95.0|1.37|1.87|||Chi-squared|||||1.87|1.37|<0.001
70911813|NCT01222247|141313682|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
70911814|NCT01222247|141313683|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.93||||0.4|TWO_SIDED|95.0|0.78|1.1|||Chi-squared|||||1.10|0.78|0.40
70911815|NCT01222247|141313684|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.17||||0.15|TWO_SIDED|95.0|0.95|1.4|||Chi-squared|||||1.40|0.95|0.15
70911816|NCT01222247|141313685|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.16||||0.24|TWO_SIDED|95.0|0.91|1.47|||Chi-squared|||||1.47|0.91|0.24
70911817|NCT01222247|141313686|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.93||||0.09|TWO_SIDED|95.0|0.85|1.01|||Chi-squared|||Analysis for NICU stay of any duration||1.01|0.85|0.09
70911818|NCT01222247|141313686|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.89||||0.03|TWO_SIDED|95.0|0.8|0.98|||Chi-squared|||Analysis for duration greater than or equal to 3 days||0.98|0.80|0.03
70911819|NCT01222247|141313687|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.20
70911820|NCT01222247|141313688|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.61||||0.08|TWO_SIDED|95.0|0.35|1.07|||Chi-squared|||Statistical analysis for chorioamnionitis||1.07|0.35|0.08
70911821|NCT01222247|141313688|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.98||||0.96|TWO_SIDED|95.0|0.49|1.95|||Chi-squared|||Analysis for Postpartum Endometritis||1.95|0.49|0.96
70911822|NCT01222247|141313688|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.03||||0.56|TWO_SIDED|95.0|0.93|1.15|||Chi-squared|||Statistical analysis for cesarean delivery||1.15|0.93|0.56
71092617|NCT00311168|141691649|SUPERIORITY|A target of an 80% reduction in percentage of ventricular pacing with VIP™ is proposed in this study. In order to achieve an 80% power of detecting an 80% reduction in the percentage of ventricular paced events and using a two group two-sided t-test of equal means, a minimum sample size of 39 patients per group was required. To account for possible withdrawal or loss to follow-up, this study targeted to enroll 100 patients (50 per group).|Mean Difference (Final Values)|-60.2|STANDARD_DEVIATION|19.0|<|0.0001|TWO_SIDED|95.0|-67.5|-52.9|||t-test, 2 sided||Mean difference in the percentage of intrinsic ventricular events is presented as, VIP Off - VIP On.|||-52.9|-67.5|<0.0001
70911823|NCT01222247|141313689|SUPERIORITY_OR_OTHER_LEGACY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Analysis for interval from randomization to delivery||||0.57
70911824|NCT01222247|141313690|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
70911825|NCT02042443|141313713|SUPERIORITY||Hazard Ratio (HR)|2.02||||0.05|TWO_SIDED|95.0|1.01|4.03|||Log Rank|||||4.03|1.01|0.05
70911826|NCT05550337|141313734|EQUIVALENCE|The 90% CI for the Test-to-Reference ratio of LS mean percent reduction from Baseline to Week 12/Day 84, in the inflammatory lesion counts to be contained within (0.80, 1.25).|Mean Difference (Net)|0.998|||||TWO_SIDED|90.0|0.927|1.076||||||||1.076|0.927|
70911827|NCT05550337|141313735|EQUIVALENCE|The 90% CI for the Test-to-Reference ratio of LS mean percent reduction from Baseline to Week 12/Day 84, in the non-inflammatory lesion counts to be contained within (0.80, 1.25).|Mean Difference (Net)|1.116|||||TWO_SIDED|90.0|1.017|1.228||||||||1.228|1.017|
70911828|NCT01140347|141313742|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.866||||0.1391|TWO_SIDED|95.0|0.717|1.046|||Log Rank||HR with 95% confidence interval (CI) was estimated using a stratified Cox proportional hazards regression model using the Interactive Web Response System (IWRS) stratification factors (geographical regions and etiology of liver disease).|||1.046|0.717|0.1391
70911829|NCT01140347|141313743|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.625|||<|0.0001|TWO_SIDED|95.0|0.522|0.75|||Log Rank||HR with 95% CI was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors (geographical regions and etiology of liver disease).|||0.750|0.522|<0.0001
70911830|NCT01140347|141313744|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) adjusted for geographic region and etiology liver disease||||||<0.0001
70911831|NCT01140347|141313745|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.593|||<|0.0001|TWO_SIDED|95.0|0.487|0.722|||Log Rank||HR with 95% CI was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors (geographical regions and etiology of liver disease).|||0.722|0.487|<0.0001
70911832|NCT02501811|141313756|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|1.05||0.993|TWO_SIDED|95.0|-2.19|2.023|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values|Confidence intervals based on t-test|||2.023|-2.190|0.993
70911833|NCT02501811|141313756|SUPERIORITY||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.96||0.499|TWO_SIDED|95.0|-1.229|2.635|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||2.635|-1.229|0.499
70911834|NCT02501811|141313756|SUPERIORITY||Mean Difference (Final Values)|1.38|STANDARD_ERROR_OF_MEAN|1.05||0.578|TWO_SIDED|95.0|-0.729|3.485|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||3.485|-0.729|0.578
70911835|NCT02501811|141313756|SUPERIORITY||Mean Difference (Final Values)|-1.46|STANDARD_ERROR_OF_MEAN|1.04||0.523|TWO_SIDED|95.0|-3.552|0.629|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||0.629|-3.552|0.523
70911836|NCT02501811|141313756|SUPERIORITY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.95||0.471|TWO_SIDED|95.0|-2.7|1.127|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||1.127|-2.7|0.471
70911837|NCT02501811|141313756|SUPERIORITY||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|0.95||0.485|TWO_SIDED|95.0|-1.24|2.59|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||2.590|-1.240|0.485
71092618|NCT03282097|141691684|SUPERIORITY|||||||0.4393|||||||ANCOVA|||||||0.4393
70911838|NCT02501811|141313757|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|1.05||0.942|TWO_SIDED|95.0|-2.406|1.887|||ANCOVA|The change in global circumferential strain was compared using ANCOVA analyses adjusting for baseline values|Confidence intervals based on t-test|||1.887|-2.406|0.942
70911839|NCT02501811|141313757|SUPERIORITY||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|1.17||0.282|TWO_SIDED|95.0|-1.815|2.975|||ANCOVA|The change in global circumferential strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||2.975|-1.815|0.282
70911840|NCT02501811|141313757|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.95||0.163|TWO_SIDED|95.0|-1.31|2.635|||ANCOVA|The change in global circumferential strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||2.635|-1.310|0.163
70911841|NCT02501811|141313757|SUPERIORITY||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.77||0.175|TWO_SIDED|95.0|-2.471|0.628|||ANCOVA|The change in global circumferential strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.628|-2.471|0.175
71092619|NCT03282097|141691685|SUPERIORITY|||||||0.2262|||||||ANCOVA|||||||.2262
71092620|NCT03282097|141691686|SUPERIORITY|||||||0.0023|||||||ANCOVA|||||||0.0023
70911842|NCT02501811|141313757|SUPERIORITY||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|1.03||0.329|TWO_SIDED|95.0|-2.932|1.254|||ANCOVA|The change in global circumferential strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.254|-2.932|0.329
70911843|NCT02501811|141313757|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.93||0.752|TWO_SIDED|95.0|-1.829|1.994|||ANCOVA|The change in global circumferential strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||1.994|-1.829|0.752
70911844|NCT02501811|141313758|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.75||0.733|TWO_SIDED|95.0|-1.118|1.927|||ANCOVA|The change in regional longitudinal strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||1.927|-1.118|0.733
71092621|NCT03282097|141691687|SUPERIORITY|||||||0.6075|||||||Regression, Logistic|||||||0.6075
70911845|NCT02501811|141313758|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.81||0.735|TWO_SIDED|95.0|-1.248|2.041|||ANCOVA|The change in regional longitudinal strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||2.041|-1.248|0.735
70911846|NCT02501811|141313758|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.8||0.794|TWO_SIDED|95.0|-1.464|1.767|||ANCOVA|The change in regional longitudinal strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.767|-1.464|0.794
70911847|NCT02501811|141313758|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.7||0.951|TWO_SIDED|95.0|-1.161|1.666|||ANCOVA|The change in regional longitudinal strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.666|-1.161|0.951
70911848|NCT02501811|141313758|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.71||0.962|TWO_SIDED|95.0|-1.441|1.457|||ANCOVA|The change in regional longitudinal strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.457|-1.441|0.962
70911849|NCT02501811|141313758|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.76||0.945|TWO_SIDED|95.0|-1.793|1.303|||ANCOVA|The change in regional longitudinal strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.303|-1.793|0.945
70911850|NCT02501811|141313759|SUPERIORITY||Mean Difference (Final Values)|-2.02|STANDARD_ERROR_OF_MEAN|3.85||0.602|TWO_SIDED|95.0|-9.754|5.711|||ANCOVA|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||5.711|-9.754|0.602
70911851|NCT02501811|141313759|SUPERIORITY||Mean Difference (Final Values)|-2.78|STANDARD_ERROR_OF_MEAN|3.39||0.443|TWO_SIDED|95.0|-9.609|4.044|||ANCOVA|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||4.044|-9.609|0.443
70911852|NCT02501811|141313759|SUPERIORITY||Mean Difference (Net)|-4.13|STANDARD_ERROR_OF_MEAN|3.42||0.348|TWO_SIDED|95.0|-11.011|2.76|||ANCOVA|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||2.760|-11.011|0.348
70911853|NCT02501811|141313759|SUPERIORITY||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|3.92||0.812|TWO_SIDED|95.0|-5.76|9.968|||ANCOVA|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||9.968|-5.760|0.812
70911854|NCT02501811|141313759|SUPERIORITY||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|3.89||0.9|TWO_SIDED|95.0|-7.052|8.574|||ANCOVA|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||8.574|-7.052|0.900
70911855|NCT02501811|141313759|SUPERIORITY||Mean Difference (Final Values)|-1.34|STANDARD_ERROR_OF_MEAN|3.47||0.848|TWO_SIDED|95.0|-8.321|5.635|||ANCOVA|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||5.635|-8.321|0.848
70911856|NCT02501811|141313760|SUPERIORITY||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|3.01||0.659|TWO_SIDED|95.0|-7.281|4.789|||ANCOVA|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||4.789|-7.281|0.659
70911857|NCT02501811|141313760|SUPERIORITY||Mean Difference (Final Values)|-2.46|STANDARD_ERROR_OF_MEAN|3.06||0.466|TWO_SIDED|95.0|-8.621|3.71|||ANCOVA|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||3.710|-8.621|0.466
70911858|NCT02501811|141313760|SUPERIORITY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|3.08||0.293|TWO_SIDED|95.0|-10.799|1.594|||ANCOVA|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.594|-10.799|0.293
70911859|NCT02501811|141313760|SUPERIORITY||Mean Difference (Final Values)|3.36|STANDARD_ERROR_OF_MEAN|3.06||0.53|TWO_SIDED|95.0|-2.795|9.508|||ANCOVA|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||9.508|-2.795|0.530
70911860|NCT02501811|141313760|SUPERIORITY||Mean Difference (Final Values)|1.21|STANDARD_ERROR_OF_MEAN|3.05||0.761|TWO_SIDED|95.0|-4.91|7.33|||ANCOVA|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||7.330|-4.910|0.761
70911861|NCT02501811|141313760|SUPERIORITY||Mean Difference (Final Values)|-2.15|STANDARD_ERROR_OF_MEAN|3.12||0.669|TWO_SIDED|95.0|-8.426|4.132|||ANCOVA|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||4.132|-8.426|0.669
70911862|NCT02501811|141313761|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.989|TWO_SIDED|95.0|-0.048|0.04|||ANCOVA|The change in left ventricular sphericity index was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.040|-0.048|0.989
70911863|NCT02501811|141313761|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.493|TWO_SIDED|95.0|-0.056|0.033|||ANCOVA|The change in left ventricular sphericity index was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.033|-0.056|0.493
70911864|NCT02501811|141313761|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.926|TWO_SIDED|95.0|-0.053|0.039|||ANCOVA|The change in left ventricular sphericity index was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.039|-0.053|0.926
70911865|NCT02501811|141313761|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.904|TWO_SIDED|95.0|-0.041|0.047|||ANCOVA|The change in left ventricular sphericity index was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.047|-0.041|0.904
70911866|NCT02501811|141313761|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.476|TWO_SIDED|95.0|-0.035|0.049|||ANCOVA|The change in left ventricular sphericity index was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.049|-0.035|0.476
70911867|NCT02501811|141313761|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.515|TWO_SIDED|95.0|-0.04|0.048|||ANCOVA|The change in left ventricular sphericity index was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.048|-0.040|0.515
71092622|NCT03282097|141691688|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<.0001
71092623|NCT03282097|141691689|SUPERIORITY||||||<|0.0001|||||||Regression, Logistic|||||||<0.0001
70911868|NCT02501811|141313762|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.85||0.569|TWO_SIDED|95.0|-1.77|1.687|||ANCOVA|The change in scar size percent was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.687|-1.770|0.569
70911869|NCT02501811|141313762|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.8||0.767|TWO_SIDED|95.0|-1.792|1.457|||ANCOVA|The change in scar size percent was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.457|-1.792|0.767
70911870|NCT02501811|141313762|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.71||0.261|TWO_SIDED|95.0|-1.965|0.921|||ANCOVA|The change in scar size percent was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.921|-1.965|0.261
70911871|NCT02501811|141313762|SUPERIORITY||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.86||0.587|TWO_SIDED|95.0|-1.261|2.222|||ANCOVA|The change in scar size percent was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||2.222|-1.261|0.587
70911872|NCT02501811|141313762|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.93||0.994|TWO_SIDED|95.0|-1.763|2.014|||ANCOVA|The change in scar size percent was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||2.014|-1.763|0.994
70911873|NCT02501811|141313762|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.81||0.639|TWO_SIDED|95.0|-1.993|1.283|||ANCOVA|The change in scar size percent was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.283|-1.993|0.639
70911874|NCT02501811|141313763|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|1.42||0.992|TWO_SIDED|95.0|-2.437|3.319|||ANCOVA|The change in scar tissue mass was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||3.319|-2.437|0.992
70911875|NCT02501811|141313763|SUPERIORITY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|1.22||0.862|TWO_SIDED|95.0|-2.278|2.643|||ANCOVA|The change in scar tissue mass was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||2.643|-2.278|0.862
70911876|NCT02501811|141313763|SUPERIORITY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|1.31||0.217|TWO_SIDED|95.0|-3.846|1.443|||ANCOVA|The change in scar tissue mass was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||1.443|-3.846|0.217
70911877|NCT02501811|141313763|SUPERIORITY||Mean Difference (Final Values)|1.64|STANDARD_ERROR_OF_MEAN|1.47||0.327|TWO_SIDED|95.0|-1.325|4.611|||ANCOVA|The change in scar tissue mass was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||4.611|-1.325|0.327
70911878|NCT02501811|141313763|SUPERIORITY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|1.39||0.859|TWO_SIDED|95.0|-2.551|3.068|||ANCOVA|The change in scar tissue mass was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||3.068|-2.551|0.859
70911879|NCT02501811|141313763|SUPERIORITY||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|1.27||0.338|TWO_SIDED|95.0|-3.952|1.184|||ANCOVA|The change in scar tissue mass was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||1.184|-3.952|0.338
70911880|NCT02501811|141313764|SUPERIORITY||Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.71||0.157|TWO_SIDED|95.0|-2.456|0.411|||ANCOVA|The change in peak VO2 was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.411|-2.456|0.157
70911881|NCT02501811|141313764|SUPERIORITY||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.9||0.428|TWO_SIDED|95.0|-2.798|0.859|||ANCOVA|The change in peak VO2 was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.859|-2.798|0.428
70911882|NCT02501811|141313764|SUPERIORITY||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.73||0.382|TWO_SIDED|95.0|-0.83|2.093|||ANCOVA|The change in peak VO2 was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||2.093|-0.83|0.382
70911883|NCT02501811|141313764|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|0.8||0.056|TWO_SIDED|95.0|-3.255|-0.052|||ANCOVA|The change in peak VO2 was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||-0.052|-3.255|0.056
71153667|NCT02093819|141799994|SUPERIORITY_OR_OTHER||Slope|1.0732|STANDARD_ERROR_OF_MEAN|0.0468|||TWO_SIDED|90.0|0.9946|1.1518|||||Evaluation of dose proportionality - all dose groups. Number of subjects included in the analysis=44.|A power model was used to describe functional relationship between dose and Pk parameters. For the evaluation of dose proportionality,slope parameter (B), a two-sided 90% confidence interval of the slope was calculated. Perfect dose proportionality would correspond to a slope of 1.||1.1518|0.9946|
70911884|NCT02501811|141313764|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.96||0.61|TWO_SIDED|95.0|-1.991|1.885|||ANCOVA|The change in peak VO2 was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.885|-1.991|0.610
70911885|NCT02501811|141313764|SUPERIORITY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|0.97||0.195|TWO_SIDED|95.0|-0.356|3.557|||ANCOVA|The change in peak VO2 was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||3.557|-0.356|0.195
70911886|NCT02501811|141313765|SUPERIORITY||Mean Difference (Final Values)|18.57|STANDARD_ERROR_OF_MEAN|19.01||0.348|TWO_SIDED|95.0|-19.537|56.687|||ANCOVA|The change in exercise tolerance was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||56.687|-19.537|0.348
70911887|NCT02501811|141313765|SUPERIORITY||Mean Difference (Final Values)|23.19|STANDARD_ERROR_OF_MEAN|17.88||0.23|TWO_SIDED|95.0|-12.759|59.134|||ANCOVA|The change in exercise tolerance was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||59.134|-12.759|0.230
70911888|NCT02501811|141313765|SUPERIORITY||Mean Difference (Final Values)|1.69|STANDARD_ERROR_OF_MEAN|16.21||0.905|TWO_SIDED|95.0|-30.974|34.361|||ANCOVA|The change in exercise tolerance was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||34.361|-30.974|0.905
70911889|NCT02501811|141313765|SUPERIORITY||Mean Difference (Final Values)|16.88|STANDARD_ERROR_OF_MEAN|15.98||0.335|TWO_SIDED|95.0|-15.267|49.03|||ANCOVA|The change in exercise tolerance was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||49.030|-15.267|0.335
70911890|NCT02501811|141313765|SUPERIORITY||Mean Difference (Final Values)|-4.61|STANDARD_ERROR_OF_MEAN|17.68||0.827|TWO_SIDED|95.0|-40.106|30.88|||ANCOVA|The change in exercise tolerance was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||30.880|-40.106|0.827
70911891|NCT02501811|141313765|SUPERIORITY||Mean Difference (Final Values)|-21.49|STANDARD_ERROR_OF_MEAN|14.63||0.163|TWO_SIDED|95.0|-50.989|8.001|||ANCOVA|The change in exercise tolerance was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||8.001|-50.989|0.163
70911892|NCT02501811|141313766|SUPERIORITY||Mean Difference (Final Values)|-9.64|STANDARD_ERROR_OF_MEAN|4.63||0.023|TWO_SIDED|95.0|-18.915|-0.357|||ANCOVA|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||-0.357|-18.915|0.023
70911893|NCT02501811|141313766|SUPERIORITY||Mean Difference (Final Values)|-15.09|STANDARD_ERROR_OF_MEAN|5.84||0.05|TWO_SIDED|95.0|-26.871|-3.319|||ANCOVA|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||-3.319|-26.871|0.050
70911894|NCT02501811|141313766|SUPERIORITY||Mean Difference (Final Values)|-2.97|STANDARD_ERROR_OF_MEAN|5.86||0.119|TWO_SIDED|95.0|-14.784|8.836|||ANCOVA|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||8.836|-14.784|0.119
70911895|NCT02501811|141313766|SUPERIORITY||Mean Difference (Final Values)|-6.66|STANDARD_ERROR_OF_MEAN|5.66||0.845|TWO_SIDED|95.0|-18.087|4.762|||ANCOVA|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||4.762|-18.087|0.845
70911896|NCT02501811|141313766|SUPERIORITY||Mean Difference (Final Values)|5.46|STANDARD_ERROR_OF_MEAN|5.64||0.976|TWO_SIDED|95.0|-5.931|16.848|||ANCOVA|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||16.848|-5.931|0.976
70911897|NCT02501811|141313766|SUPERIORITY||Mean Difference (Final Values)|12.12|STANDARD_ERROR_OF_MEAN|6.69||0.717|TWO_SIDED|95.0|-1.337|25.578|||ANCOVA|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||25.578|-1.337|0.717
70911898|NCT02501811|141313767|SUPERIORITY||Mean Difference (Final Values)|-1411.7|STANDARD_ERROR_OF_MEAN|840.6||0.11|TWO_SIDED|95.0|-3108.3|284.9|||ANCOVA|Change in NT-proBNP value compared using ANCOVA analyses adjusting for baseline values. Data log transformed, p-values obtained from transformed data|Confidence intervals based on t test|||284.9|-3108.3|0.110
70911899|NCT02501811|141313767|SUPERIORITY||Mean Difference (Final Values)|-634.6|STANDARD_ERROR_OF_MEAN|405.1||0.112|TWO_SIDED|95.0|-1460.7|191.4|||ANCOVA|Change in NT-proBNP value compared using ANCOVA analyses adjusting for baseline values. Data log transformed, p-values obtained from transformed data|Confidence intervals based on t test|||191.4|-1460.7|0.112
70911900|NCT02501811|141313767|SUPERIORITY||Mean Difference (Final Values)|-483.2|STANDARD_ERROR_OF_MEAN|400.7||0.891|TWO_SIDED|95.0|-1301.5|335.2|||ANCOVA|Change in NT-proBNP value compared using ANCOVA analyses adjusting for baseline values. Data log transformed, p-values obtained from transformed data|Confidence intervals based on t test|||335.2|-1301.5|0.891
70911901|NCT02501811|141313767|SUPERIORITY||Mean Difference (Final Values)|-928.6|STANDARD_ERROR_OF_MEAN|754.2||0.009|TWO_SIDED|95.0|-2470.7|613.6|||ANCOVA|Change in NT-proBNP value compared using ANCOVA analyses adjusting for baseline values. Data log transformed, p-values obtained from transformed data|Confidence intervals based on t test|||613.6|-2470.7|0.009
70911902|NCT02501811|141313767|SUPERIORITY||Mean Difference (Final Values)|-777.1|STANDARD_ERROR_OF_MEAN|756.5||0.661|TWO_SIDED|95.0|-2323.2|769.1|||ANCOVA|Change in NT-proBNP value compared using ANCOVA analyses adjusting for baseline values. Data log transformed, p-values obtained from transformed data|Confidence intervals based on t test|||769.1|-2323.2|0.661
70911903|NCT02501811|141313767|SUPERIORITY||Mean Difference (Final Values)|151.5|STANDARD_ERROR_OF_MEAN|162.2||0.015|TWO_SIDED|95.0|-175.4|478.4|||ANCOVA|Change in NT-proBNP value compared using ANCOVA analyses adjusting for baseline values. Data log transformed, p-values obtained from transformed data|Confidence intervals based on t test|||478.4|-175.4|0.015
70911904|NCT02501811|141313768|OTHER||slope of time|0.267|STANDARD_ERROR_OF_MEAN|0.241||0.269|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported||||0.269
70911905|NCT02501811|141313769|OTHER||slope of time|0.141|STANDARD_ERROR_OF_MEAN|0.153||0.361|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.361
70911906|NCT02501811|141313770|OTHER||slope of time|-0.267|STANDARD_ERROR_OF_MEAN|0.164||0.107|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.107
70850339|NCT02657408|141188418|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|1.03|||||TWO_SIDED|90.0|0.9|1.18||||||The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.18|0.90|
70911907|NCT02501811|141313771|OTHER||slope of time|1.395|STANDARD_ERROR_OF_MEAN|0.829||0.095|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.095
70911908|NCT02501811|141313772|OTHER||slope of time|0.603|STANDARD_ERROR_OF_MEAN|0.683||0.379|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.379
70911909|NCT02501811|141313773|OTHER||slope of time|0.003|STANDARD_ERROR_OF_MEAN|0.004||0.401|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.401
70911910|NCT02501811|141313774|OTHER||slope of time|-0.244|STANDARD_ERROR_OF_MEAN|0.158||0.126|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.126
71092624|NCT06001021|141691711|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008).~Lesaffre E. Superiority, equivalence, and non-inferiority trials. Bull NYU Hosp Jt Dis. 2008;66(2):150-4. PMID: 18537788."|Mean Difference (Final Values)|-35.55|STANDARD_DEVIATION|17.78||0|TWO_SIDED|90.0|-38.9|-32.19||The significance level is 0.10 with 90% confidence interval|ANCOVA|||||-32.19|-38.90|0.000
70911911|NCT02501811|141313775|OTHER||slope of time|-0.42|STANDARD_ERROR_OF_MEAN|0.281||0.139|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.139
70911912|NCT02501811|141313776|OTHER||slope of time|-0.133|STANDARD_ERROR_OF_MEAN|0.184||0.472|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.472
70911913|NCT02501811|141313777|OTHER||slope of time|6.544|STANDARD_ERROR_OF_MEAN|2.882||0.025|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.025
70911914|NCT02501811|141313778|OTHER||slope with interaction|-7.08|STANDARD_ERROR_OF_MEAN|3.3||0.037|TWO_SIDED||||||Regression, Linear|||Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. A time by treatment interaction was assessed.||||0.037
70911915|NCT02501811|141313778|OTHER||slope with interaction|-6.78|STANDARD_ERROR_OF_MEAN|3.18||0.035|TWO_SIDED||||||Regression, Linear|||Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. A time by treatment interaction was assessed.||||0.035
70911916|NCT02501811|141313779|OTHER||slope of time|84.557|STANDARD_ERROR_OF_MEAN|35.81||0.092|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.092
70911917|NCT01124162|141313828|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|108.14|||||TWO_SIDED|90.0|97.43|120.03|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||120.03|97.43|
70911918|NCT01124162|141313829|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|101.7|||||TWO_SIDED|90.0|98.57|104.93|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104.93|98.57|
70911919|NCT01124162|141313830|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|101.5|||||TWO_SIDED|90.0|98.41|104.68|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104.68|98.41|
70911920|NCT01124162|141313831|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|102.08|||||TWO_SIDED|90.0|98.24|106.06|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||106.06|98.24|
71092625|NCT06001021|141691712|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008). Lesaffre E. Superiority, equivalence, and non-inferiority trials. Bull NYU Hosp Jt Dis.~2008;66(2):150-4. PMID: 18537788"|Mean Difference (Final Values)|23.96|STANDARD_DEVIATION|23.14||0|TWO_SIDED|90.0|19.59|28.32||The significance level is 0.10 with 90% confidence interval|ANCOVA|||||28.32|19.59|0.000
70911921|NCT01124162|141313832|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|100.31|||||TWO_SIDED|90.0|97.84|102.84|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.84|97.84|
70911922|NCT01124162|141313833|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|100.25|||||TWO_SIDED|90.0|97.87|102.69|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.69|97.87|
70911923|NCT02680756|141313834|NON_INFERIORITY|A 2-sided CI for difference in the proportions of Hb responders (risk difference for ferric maltol - IV iron) between the two treatment groups, and comparing the LCL of this CI to the pre-specified non-inferiority margin of 20%. The CI was calculated using the Delta Method approach based on a logistic regression model, adjusted for treatment group, baseline Hb (below the observed median or at least the observed median), and IBD subgroup (UC or CD).|Risk Difference (RD)|-0.17||||0.298|TWO_SIDED|95.0|-0.28|-0.06|||t-test, 2 sided|||||-0.06|-0.28|0.298
70911924|NCT02680756|141313835|NON_INFERIORITY|A 2-sided CI for difference in the proportions of Hb responders (risk difference for ferric maltol - IV iron) between the two treatment groups, and comparing the LCL of this CI to the pre-specified non-inferiority margin of 20%. The CI was calculated using the Delta Method approach based on a logistic regression model, adjusted for treatment group, baseline Hb (below the observed median or at least the observed median), and IBD subgroup (UC or CD).|Risk Difference (RD)|-0.17||||0.341|TWO_SIDED|95.0|-0.3|-0.05|||t-test, 2 sided|||||-0.05|-0.30|0.341
70911925|NCT03613129|141313856|NON_INFERIORITY|Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS||||||0.011|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.011
70911926|NCT03613129|141313856|NON_INFERIORITY|Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS||||||0.136|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.136
70911927|NCT03613129|141313856|NON_INFERIORITY|Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS||||||0.009|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.009
70911928|NCT03613129|141313856|NON_INFERIORITY|Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS||||||0.451|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.451
70911929|NCT03613129|141313856|NON_INFERIORITY|Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS||||||0.24|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.240
70911930|NCT03613129|141313857|NON_INFERIORITY|Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)||||||0.039|||||||t-test, 2 sided|||||||0.039
70911931|NCT03613129|141313857|NON_INFERIORITY|Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)||||||0.191|||||||t-test, 2 sided|||||||0.191
70911932|NCT03613129|141313857|NON_INFERIORITY|Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)||||||0.016|||||||t-test, 2 sided|||||||0.016
70911933|NCT03613129|141313857|NON_INFERIORITY|Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)||||||0.053|||||||t-test, 2 sided|||||||0.053
70911934|NCT03613129|141313857|NON_INFERIORITY|Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)||||||0.06|||||||t-test, 2 sided|||||||0.060
70911935|NCT03613129|141313858|NON_INFERIORITY|Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)||||||0.587|||||||t-test, 2 sided|||||||0.587
70911936|NCT03613129|141313858|NON_INFERIORITY|Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)||||||0.618|||||||t-test, 2 sided|||||||0.618
71153668|NCT02093819|141799994|SUPERIORITY_OR_OTHER||Slope|0.9603|STANDARD_ERROR_OF_MEAN|0.0838|||TWO_SIDED|90.0|0.8174|1.1032|||||Evaluation of dose proportionality - dose groups 50 mg to 600 mg. Number of subjects included in the analysis 28.|A power model was used to describe functional relationship between dose and Pk parameters. For the evaluation of dose proportionality,slope parameter (B), a two-sided 90% confidence interval of the slope was calculated. Perfect dose proportionality would correspond to a slope of 1.||1.1032|0.8174|
70911937|NCT03613129|141313858|NON_INFERIORITY|Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)||||||0.634|||||||t-test, 2 sided|||||||0.634
70911938|NCT03613129|141313858|NON_INFERIORITY|Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)||||||0.355|||||||t-test, 2 sided|||||||0.355
70911939|NCT03613129|141313858|NON_INFERIORITY|Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)||||||0.417|||||||t-test, 2 sided|||||||0.417
70911940|NCT00938340|141313859|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0|||||Mixed Models Analysis|||||||0.012
70911941|NCT00938340|141313859|SUPERIORITY_OR_OTHER_LEGACY|||||||0.52||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.52
70911942|NCT00938340|141313859|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.011
70911943|NCT00938340|141313859|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.29
70911944|NCT00938340|141313859|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.002
70911945|NCT00938340|141313859|SUPERIORITY_OR_OTHER_LEGACY|||||||0.093||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.093
70911946|NCT00938340|141313859|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.12
70911947|NCT00938340|141313860|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
70911948|NCT00938340|141313860|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.15
70911949|NCT00938340|141313860|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.35
70911950|NCT00938340|141313860|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.011
70911951|NCT00938340|141313860|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.62
70911952|NCT00938340|141313860|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.0002
70911953|NCT00938340|141313860|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0013||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.0013
70911954|NCT00938340|141313861|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15||||||Main effect of treatment by timepoint|Mixed Models Analysis|||||||0.15
70911955|NCT00938340|141313862|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79|||||||Mixed Models Analysis|||||||0.79
70911956|NCT00938340|141313863|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||Mixed Models Analysis|||||||0.010
70911957|NCT00938340|141313863|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.98
70911958|NCT00938340|141313863|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.004
70911959|NCT00938340|141313863|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.11
70911960|NCT00938340|141313863|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.004
70911961|NCT00938340|141313863|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.11
70911962|NCT00938340|141313863|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.16
70911963|NCT00938340|141313864|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||Mixed Models Analysis|||||||0.007
70911964|NCT00938340|141313864|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.004
70911965|NCT00938340|141313864|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.62
70911966|NCT00938340|141313864|SUPERIORITY_OR_OTHER_LEGACY|||||||0.14||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.14
70911967|NCT00938340|141313864|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.002
70911968|NCT00938340|141313864|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.22
70850340|NCT02657408|141188419|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|1.18|||||TWO_SIDED|90.0|0.91|1.53||||||The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.53|0.91|
70911969|NCT00938340|141313864|SUPERIORITY_OR_OTHER_LEGACY|||||||0.074||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.074
70911970|NCT00938340|141313865|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53|||||||Mixed Models Analysis|||||||0.53
70911971|NCT00938340|141313866|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
70911972|NCT00938340|141313867|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
70911973|NCT00938340|141313868|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
70911974|NCT00938340|141313869|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
70911975|NCT00938340|141313870|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44|||||||Mixed Models Analysis|||||||0.44
70911976|NCT00938340|141313871|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62|||||||Mixed Models Analysis|||||||0.62
70911977|NCT00938340|141313872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011|||||||Mixed Models Analysis|||||||0.011
70911978|NCT00938340|141313872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.007
70911979|NCT00938340|141313872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.99
70911980|NCT00938340|141313872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.037||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.037
70911981|NCT00938340|141313872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0087||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.0087
70911982|NCT00938340|141313872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.64
70911983|NCT00938340|141313872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.043
70911984|NCT00938340|141313873|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
70911985|NCT00938340|141313873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.91||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.91
70911986|NCT00938340|141313873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.21
71153669|NCT02445794|141800029|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||.008
70911987|NCT00938340|141313873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.0011
70911988|NCT00938340|141313873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.0004
70911989|NCT00938340|141313873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.11
70911990|NCT00938340|141313873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.53
70911991|NCT00938340|141313873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.59||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.59
70911992|NCT00938340|141313873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.31
70911993|NCT00938340|141313873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.98
70911994|NCT00938340|141313873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.30
70911995|NCT00938340|141313873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.91||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.91
70911996|NCT00938340|141313873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.12
70911997|NCT00938340|141313873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.007
70911998|NCT00938340|141313873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0089||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.0089
70911999|NCT00938340|141313873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.28
70912000|NCT00938340|141313873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.62
70912001|NCT00938340|141313873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.48
70912002|NCT00938340|141313873|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||<0.0001
70912003|NCT00938340|141313873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.0003
70912004|NCT00938340|141313873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.57||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.57
70912005|NCT00938340|141313873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.99
70912006|NCT00938340|141313873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.71
70912007|NCT00938340|141313873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.62
70912008|NCT00938340|141313873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.33
70912009|NCT00938340|141313873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.65||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.65
70912010|NCT00938340|141313873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.66
70912011|NCT00938340|141313873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.30
70912012|NCT00938340|141313873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.0005
70912013|NCT00938340|141313873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0085||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.0085
70912014|NCT00938340|141313873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.92
71153670|NCT02758184|141800038|OTHER||Mean Difference (Final Values)|1031.2|STANDARD_ERROR_OF_MEAN|681.7||0.15|TWO_SIDED||||||ANOVA|||||||0.15
70912015|NCT01648283|141313905|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
70912016|NCT02775435|141313961|SUPERIORITY||Hazard Ratio (HR)|0.56|||<|0.0001|TWO_SIDED|95.0|0.45|0.7||Treatment comparison stratified by programmed cell death-ligand 1 (PD-L1) status (Tumor Proportion Score \[TPS\] ≥1% vs. \<1%), taxane chemotherapy (paclitaxel vs. nab-paclitaxel) \& geographic region (East Asia vs. non-East Asia)|Regression, Cox|||||0.70|0.45|<0.0001
70912017|NCT02775435|141313962|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.0008|TWO_SIDED|95.0|0.49|0.85||Treatment comparison stratified by programmed cell death-ligand 1 (PD-L1) status (Tumor Proportion Score \[TPS\] ≥1% vs. \<1%), taxane chemotherapy (paclitaxel vs. nab-paclitaxel) \& geographic region (East Asia vs. non-East Asia)|Regression, Cox|||||0.85|0.49|0.0008
70912018|NCT00097253|141313973|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||Regression, Linear|||Cortisol. Analyses consisted of repeated-measures linear models fit to each dependent variable.IVs assessed in each model were odor, time, gender, expectancy group (primed vs. blind), their interactions;baseline level of the DV was included as a covariate. Post hoc tests were used as appropriate. A two-sided significance level of alpha = 0.05 was used. Model controlled for Time 1 baseline.||||0.83
70912019|NCT00097253|141313973|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||Mixed Models Analysis|||Epinephrine. Analyses consisted of repeated-measures linear models fit to each dependent variable.IVs assessed in each model were odor, time, gender, expectancy group (primed vs. blind), their interactions;baseline level of the DV was included as a covariate. Post hoc tests were used as appropriate. A two-sided significance level of alpha = 0.05 was used. Model controlled for Time 1 baseline.||||0.16
70912020|NCT00097253|141313973|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||Mixed Models Analysis|||Norepinephrine. Model controlled for Time 1 baseline. Comparing timepoints 4 and 5 for pre versus post stressor, e.g. lemon versus water control; Citrus(5-4)-Water(5-4).||||0.017
70912021|NCT00097253|141313974|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Mixed Models Analysis|||IL-6. Mixed effect linear models were used to test the hypothesis. These models included the post-odor and post-stress dependent variable measurements with a covariate for the baseline pre-odor measurement. Base 10 logarithms were used for each dependent variable and baseline covariate.||||0.10
70912022|NCT00097253|141313974|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Mixed Models Analysis|||IL-10. Mixed effect linear models were used to test the hypothesis. These models included the post-odor and post-stress dependent variable measurements with a covariate for the baseline pre-odor measurement. Base 10 logarithms were used for each dependent variable and baseline covariate.||||0.50
70912023|NCT00097253|141313975|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Mixed Models Analysis|||Repeated-measures mixed effects models were used. Model was fit to the log-transformed data. Analysis applied to odor category, e.g. lavender / lemon / water.||||0.60
70912024|NCT00097253|141313976|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Regression, Linear|||The maximum DTH wheal of days 1-3 (24, 48, or 72 h) was used as the dependent variable for each subject at each visit. Visits for subjects with a maximum DTH wheal of 5mm or less were excluded. A repeated measures linear model was used to evaluate odor and placebo effects.||||0.014
70912025|NCT03124108|141313977|SUPERIORITY||Difference in percentage|-52.0|STANDARD_ERROR_OF_MEAN|5.4|<|0.001|TWO_SIDED|95.0|-62.5|-41.5|||ANCOVA|||||-41.5|-62.5|<0.001
70912026|NCT03124108|141313977|SUPERIORITY||Difference in percentage|-43.9|STANDARD_ERROR_OF_MEAN|6.0|<|0.001|TWO_SIDED|95.0|-55.7|-32.1|||ANCOVA|||||-32.1|-55.7|<0.001
70912027|NCT01219855|141314024|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Z-test cmpared 2 independ. proportions|||||||<0.0001
70912028|NCT01219855|141314025|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Mixed effect model|||||||<0.01
70912029|NCT01219855|141314026|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed effect model|||||||<0.0001
70912030|NCT01219855|141314026|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Mixed effect model|||||||<0.01
70912031|NCT01219855|141314027|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed effect model|||||||<0.0001
70912032|NCT01219855|141314028|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Z-test compared 2 independ. proportions|||||||<0.05
70912033|NCT01219855|141314029|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Z-test compared 2 independ. proportions|||The proportion of subjects achieving a ≥20% decrease in plasma iPTH at EOT was greater in the CTAP101 Capsules 60 and 90 μg groups compared to the corresponding placebo group.||||<0.001
70912034|NCT03852433|141314070|OTHER||Difference in percentages|34.0||||0.0003|TWO_SIDED|95.0|14.6|50.4|||Fisher Exact|||||50.4|14.6|0.0003
70912035|NCT03852433|141314070|OTHER||Difference in percentages|15.3||||0.2631|TWO_SIDED|95.0|-8.2|34.2|||Fisher Exact|||||34.2|-8.2|0.2631
70912036|NCT03852433|141314070|OTHER||Difference in percentages|29.3||||0.0197|TWO_SIDED|95.0|1.8|48.2|||Fisher Exact|||||48.2|1.8|0.0197
70912037|NCT03852433|141314070|OTHER||Difference in percentages|-4.7||||0.7186|TWO_SIDED|95.0|-26.3|11.8|||Fisher Exact|||||11.8|-26.3|0.7186
70912038|NCT03852433|141314070|OTHER||Difference in percentages|14.0||||0.2184|TWO_SIDED|95.0|-5.5|32.7|||Fisher Exact|||||32.7|-5.5|0.2184
70912039|NCT03852433|141314070|OTHER||Difference in percentages|-20.0||||0.0283|TWO_SIDED|95.0|-36.1|-3.5|||Fisher Exact|||||-3.5|-36.1|0.0283
70912040|NCT03852433|141314073|OTHER||Difference in percentages|26.0||||0.0134|TWO_SIDED|95.0|6.0|44.0|||Fisher Exact|||||44.0|6.0|0.0134
70912041|NCT03852433|141314074|OTHER||Difference in percentages|28.0||||0.0049|TWO_SIDED|95.0|8.2|45.1|||Fisher Exact|||||45.1|8.2|0.0049
70912042|NCT03852433|141314075|OTHER||Difference in percentages|34.0||||0.0003|TWO_SIDED|95.0|14.6|50.4|||Fisher Exact|||||50.4|14.6|0.0003
70912043|NCT03852433|141314075|OTHER||Difference in percentages|1.0||||1|TWO_SIDED|95.0|-22.8|21.4|||Fisher Exact|||||21.4|-22.8|1.0000
70912044|NCT03852433|141314075|OTHER||Difference in percentages|21.0||||0.1265|TWO_SIDED|95.0|-5.3|42.2|||Fisher Exact|||||42.2|-5.3|0.1265
70912045|NCT03852433|141314075|OTHER||Difference in percentages|-13.0||||0.1863|TWO_SIDED|95.0|-35.3|5.4|||Fisher Exact|||||5.4|-35.3|0.1863
70912046|NCT03852433|141314075|OTHER||Difference in percentages|20.0||||0.0601|TWO_SIDED|95.0|1.0|38.2|||Fisher Exact|||||38.2|1.0|0.0601
70912047|NCT03852433|141314075|OTHER||Difference in percentages|-14.0||||0.1247|TWO_SIDED|95.0|-29.9|1.7|||Fisher Exact|||||1.7|-29.9|0.1247
70912048|NCT03852433|141314076|OTHER||Difference in LS Mean|1.56||||0.0717|TWO_SIDED|95.0|-0.14|3.26|||MMRM|||||3.26|-0.14|0.0717
70912049|NCT03852433|141314076|OTHER||Difference in LS Mean|-1.84||||0.1563|TWO_SIDED|95.0|-4.39|0.71|||MMRM|||||0.71|-4.39|0.1563
70912050|NCT03852433|141314076|OTHER||Difference in LS Mean|-1.8||||0.1626|TWO_SIDED|95.0|-4.33|0.73|||MMRM|||||0.73|-4.33|0.1626
71092626|NCT06001021|141691713|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008).~Lesaffre E. Superiority, equivalence, and non-inferiority trials. Bull NYU Hosp Jt Dis. 2008;66(2):150-4. PMID: 18537788."|Mean Difference (Final Values)|86.89|STANDARD_DEVIATION|45.43||0|TWO_SIDED|90.0|78.33|95.46||The significance level is 0.10 with 90% confidence interval|ANCOVA|||||95.46|78.33|0.00
71092627|NCT06001021|141691714|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008).~Lesaffre E. Superiority, equivalence, and non-inferiority trials. Bull NYU Hosp Jt Dis. 2008;66(2):150-4. PMID: 18537788."|Mean Difference (Final Values)|22.26|STANDARD_DEVIATION|15.15||0|TWO_SIDED|90.0|19.41|25.12||The significance level is 0.10 with 90% confidence interval|ANCOVA|||||25.12|19.41|0.000
70912051|NCT03852433|141314076|OTHER||Difference in LS Mean|-3.34||||0.0099|TWO_SIDED|95.0|-5.87|-0.82|||MMRM|||||-0.82|-5.87|0.0099
70912052|NCT03852433|141314076|OTHER||Difference in LS Mean|0.07||||0.9384|TWO_SIDED|95.0|-1.67|1.81|||MMRM|||||1.81|-1.67|0.9384
70912053|NCT03852433|141314076|OTHER||Difference in LS Mean|-1.49||||0.0875|TWO_SIDED|95.0|-3.2|0.22|||MMRM|||||0.22|-3.20|0.0875
70912054|NCT03852433|141314077|OTHER||Difference in LS Mean|0.15||||0.8645|TWO_SIDED|95.0|-1.54|1.83|||MMRM|||||1.83|-1.54|0.8645
70912055|NCT03852433|141314077|OTHER||Difference in LS Mean|-0.33||||0.7033|TWO_SIDED|95.0|-2.06|1.39|||MMRM|||||1.39|-2.06|0.7033
70912056|NCT03852433|141314077|OTHER||Difference in LS Mean|-0.48||||0.5806|TWO_SIDED|95.0|-2.18|1.23|||MMRM|||||1.23|-2.18|0.5806
70912057|NCT03852433|141314078|OTHER||Difference in LS Mean|-1.68||||0.1103|TWO_SIDED|95.0|-3.75|0.39|||MMRM|||||0.39|-3.75|0.1103
70912058|NCT03852433|141314078|OTHER||Difference in LS Mean|-2.05||||0.1533|TWO_SIDED|95.0|-4.88|0.77|||MMRM|||||0.77|-4.88|0.1533
70912059|NCT03852433|141314078|OTHER||Difference in LS Mean|-2.22||||0.1129|TWO_SIDED|95.0|-4.98|0.53|||MMRM|||||0.53|-4.98|0.1129
70912060|NCT03852433|141314078|OTHER||Difference in LS Mean|-0.58||||0.6753|TWO_SIDED|95.0|-3.34|2.17|||MMRM|||||2.17|-3.34|0.6753
70912061|NCT03852433|141314078|OTHER||Difference in LS Mean|-0.12||||0.9124|TWO_SIDED|95.0|-2.28|2.04|||MMRM|||||2.04|-2.28|0.9124
70912062|NCT03852433|141314078|OTHER||Difference in LS Mean|1.56||||0.1526|TWO_SIDED|95.0|-0.59|3.7|||MMRM|||||3.70|-0.59|0.1526
70912063|NCT03643965|141314082|OTHER|Ratio of UPCR at 9 months compared to baseline for Nefecon compared to Placebo|Ratio of geometric LS means|0.73||||0.0003|TWO_SIDED|96.0|0.61|0.88|||MMRM model|||||0.88|0.61|0.0003
70912064|NCT03643965|141314083|OTHER|Time-weighted average of eGFR, Nefecon compared to Placebo|Ratio of geometric LS means|1.1|||<|0.0001|TWO_SIDED|95.0|1.06|1.15|||robust regression|||||1.15|1.06|<0.0001
70912065|NCT03643965|141314084|OTHER|Ratio of eGFR at 9 months comparison of Nefecon to Placebo|Ratio of geometric LS means|1.07||||0.0014|TWO_SIDED|95.0|1.03|1.13|||robust regression|||||1.13|1.03|0.0014
70912066|NCT03643965|141314085|OTHER|Ratio of eGFR at 12 months comparison of Nefecon to Placebo|Ratio of geometric LS means|1.07||||0.0106|TWO_SIDED|95.0|1.01|1.13|||robust regression|||||1.13|1.01|0.0106
70912067|NCT03643965|141314086|OTHER|Ratio of UACR at 9 months comparison of Nefecon to Placebo|Ratio of geometric LS means|0.69||||0.0005|TWO_SIDED|95.0|0.55|0.86|||MMRM model|||||0.86|0.55|0.0005
70912068|NCT03643965|141314087|OTHER|Time to 30% reduction in eGFR comparison Nefecon to Placebo|Hazard Ratio (HR)|0.45||||0.0028|TWO_SIDED|95.0|0.26|0.75|||Cox proportional hazards model|Cox proportional hazards model with individual patient censoring weighting.||||0.75|0.26|0.0028
70912069|NCT03643965|141314088|OTHER|Time to receiving rescue medication comparison Nefecon to Placebo|Hazard Ratio (HR)|0.68||||0.2647|TWO_SIDED|95.0|0.34|1.33|||Cox proportional hazards model|||||1.33|0.34|0.2647
70912070|NCT03643965|141314089|OTHER|Ratio of UPCR compared to baseline averaged over time points between 12 and 24 months, comparison Nefecon vs Placebo|Ratio of geometric LS means|0.59|||<|0.0001|TWO_SIDED|95.0|0.51|0.68|||MMRM model|||||0.68|0.51|<0.0001
70912071|NCT03643965|141314090|OTHER|Ratio of UACR compared to baseline averaged over time points between 12 and 24 months, Nefecon vs Placebo|Ratio of geometric LS means|0.54|||<|0.0001|TWO_SIDED|95.0|0.45|0.63|||MMRM model|||||0.63|0.45|<0.0001
70912072|NCT03643965|141314091|OTHER|Ratio of eGFR compared to baseline averaged over time points between 12 and 24 months, comparison Nefecon vs Placebo|Ratio of geometric LS means|1.11|||<|0.0001|TWO_SIDED|95.0|1.06|1.16|||robust regression|||||1.16|1.06|<0.0001
70912073|NCT03643965|141314092|OTHER|Proportion of patients without microhematuria, comparison Nefecon vs Placebo|Odds Ratio (OR)|2.5||||0.0001|TWO_SIDED|95.0|1.6|4.1|||Regression, Logistic|||||4.1|1.6|0.0001
70912074|NCT02820051|141314095|SUPERIORITY|||||||0.281||||||threshold for statistical significance: \< 0.05|Wilcoxon (Mann-Whitney)|||The sample was calculated with alpha 0.05, beta 0.20, standard deviation of 7.3,8 minimum PtcCO2 difference to detect of 5 mmHg, loss to follow-up estimated 0.20, and two-tails. According to the above, the sample size was 42 patients per group.|We tested normal distribution with the Kolmogorov-Smirnov test. Data are shown as means and standard deviations for variables with normal distribution and as medians and interquartile ranges for non-normal variables. We used the t-test, the Mann-Whitney U-test, ANOVA, or chi-square as indicated. We defined a statistically significant difference as a P value \< 0.05. The analysis was performed using SPSS version 18.0 for Windows (SPSS Inc., Chicago, IL).|||0.281
70912075|NCT02820051|141314096|SUPERIORITY|We used the t-test, the Mann-Whitney U-test, ANOVA, or chi-square as indicated. We defined a statistically significant difference as a P value \< 0.05.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70912076|NCT02820051|141314097|SUPERIORITY|T test|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70912077|NCT05302791|141314098|SUPERIORITY|||||||0.609|||||||ANOVA|time x condition ANOVA||||||.609
70912078|NCT05302791|141314099|SUPERIORITY|||||||0.858|||||||ANOVA|time x condition anova||||||.858
70912079|NCT05302791|141314100|SUPERIORITY|||||||0.633|||||||ANOVA|||||||.633
70912080|NCT05302791|141314101|SUPERIORITY|||||||0.076|||||||ANOVA|||||||.076
70912081|NCT05302791|141314102|SUPERIORITY|||||||0.151|||||||ANOVA|||||||.151
70912082|NCT05302791|141314103|SUPERIORITY|||||||0.385|||||||ANOVA|||||||.385
70912083|NCT05302791|141314104|SUPERIORITY|||||||0.665|||||||ANOVA|||||||.665
70912084|NCT05302791|141314105|SUPERIORITY|||||||0.078|||||||ANOVA|||||||.078
70912085|NCT05302791|141314106|SUPERIORITY|||||||0.773|||||||ANOVA|||||||.773
71092628|NCT06001021|141691715|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008)."|Mean Difference (Final Values)|16.44|STANDARD_DEVIATION|7.55||0|TWO_SIDED|90.0|15.02|17.87||The significance level is 0.10 with 90% confidence interval|ANCOVA|||Physical Domain of Quality of Life||17.87|15.02|0.000
71092629|NCT06001021|141691715|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008)."|Mean Difference (Final Values)|16.6|STANDARD_DEVIATION|7.62||0|TWO_SIDED|90.0|15.16|18.04||The significance level is 0.10 with 90% confidence interval.|ANCOVA|||Psychological Domain of Quality of Life||18.04|15.16|0.000
71092630|NCT06001021|141691715|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008)."|Mean Difference (Final Values)|8.26|STANDARD_DEVIATION|3.96||0|TWO_SIDED|90.0|7.52|9.01||The significance level is 0.10 with 90% confidence interval.|ANCOVA|||Social Domain of Quality of Life||9.01|7.52|0.000
71092631|NCT06001021|141691715|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008)."|Mean Difference (Final Values)|23.73|STANDARD_DEVIATION|11.07||0|TWO_SIDED|90.0|21.64|25.81||The significance level is 0.10 with 90% confidence interval.|ANCOVA|||||25.81|21.64|0.000
71092632|NCT05473039|141691736|SUPERIORITY|||||||0.2629|||||||Wilcoxon (Mann-Whitney)|||||||0.2629
71092633|NCT05473039|141691737|SUPERIORITY|||||||0.3582|||||||Wilcoxon (Mann-Whitney)|||||||0.3582
70912086|NCT05302791|141314107|SUPERIORITY|||||||0.118|||||||ANOVA|||||||.118
70912087|NCT05302791|141314108|SUPERIORITY||||||<|0.001|||||||ANOVA|Time x condition ANOVA||||||<0.001
71092634|NCT05473039|141691738|SUPERIORITY|||||||0.2187|||||||Wilcoxon (Mann-Whitney)|||||||0.2187
71092635|NCT05473039|141691739|SUPERIORITY|||||||0.3005|||||||Wilcoxon (Mann-Whitney)|||||||0.3005
70912088|NCT05302791|141314109|SUPERIORITY||||||<|0.001|||||||ANOVA|time x condition anova||||||<0.001
70912089|NCT00614744|141314122|SUPERIORITY|This trial estimated the probability that the intervention has no effect on the outcome (or conversely, the probability that it does), given the data obtained in the trial and any prior evidence.|Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.59|1.29|||Bayesian log binomial models|Bayesian log binomial models were used to analyze the primary outcome of death or moderate/severe disability.|In log binomial models used Normal (0, sd=0.35) neutral prior in the log RR scale. Estimation used Normal weakly informative priors. Reported posterior medians \& 95% credible intervals for the RR above instead of confidence intervals.|Whole-body Hypothermia vs. Normothermia (Normothermia is the comparison group)|"We fitted all Bayesian models via Markov chain Monte Carlo methods (MCMC) using JAGS (version 3.4) and OpenBUGS (3.2.3) in R (version 3.2.5). For each analysis we ran 3 MCMC chains with starting values randomly drawn from the estimated parameters from a frequentist log binomial model. A burn-in of 1,000 iterations was used, with sampling from a further 10,000 iterations for each chain. To monitor convergence, trace plots and the Gelman-Rubin convergence diagnostic (Rhat) were used for all parameters.~For all analyses, the trace plots show good mixing of the 3 chains with Rhat \< 1.01 for all parameters, indicating convergence."|1.29|0.59|
70912090|NCT02266329|141314174|SUPERIORITY||Mean Difference (Net)|-3.9|STANDARD_ERROR_OF_MEAN|1.6||0.034|TWO_SIDED|95.0|-6.9|-0.8||The significance of the study visit by treatment interaction with study visit coded as baseline, 4 weeks, 8 weeks, and 12 weeks.|Mixed Models Analysis|||Change from baseline in headache (HA) frequency (1. Primary Outcome Measure) is based on linear mixed effects regression of outcome on study visit by treatment interaction with study participant as a random effect.||-0.8|-6.9|0.034
70970608|NCT00531752|141447058|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6389|STANDARD_ERROR_OF_MEAN|3.6119||0.6519|TWO_SIDED|80.0|-3.05|6.3281|||Mixed Models Analysis|||Week 3 (PDF): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.3281|-3.050|0.6519
71092636|NCT05473039|141691740|SUPERIORITY|||||||0.0314|||||||Wilcoxon (Mann-Whitney)|||||||0.0314
71092637|NCT05473039|141691741|SUPERIORITY|||||||0.9214|||||||t-test, 2 sided|||||||0.9214
71092638|NCT05473039|141691741|SUPERIORITY|||||||0.042|||||||t-test, 2 sided|||Fasting glucose at the start of COH compared to baseline fasting glucose.||||0.042
71092639|NCT05473039|141691741|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Fasting glucose at the start of COH compared to baseline fasting glucose.||||<0.001
71092640|NCT05473039|141691742|SUPERIORITY|||||||0.59695|||||||t-test, 2 sided|||||||0.59695
71092641|NCT05473039|141691742|SUPERIORITY|||||||0.466503|||||||t-test, 2 sided|||AST at the start of COH compared to baseline AST.||||0.466503
71092642|NCT05473039|141691742|SUPERIORITY|||||||0.959877|||||||t-test, 2 sided|||AST at the start of COH compared to baseline AST.||||0.959877
71092643|NCT05473039|141691743|SUPERIORITY|||||||0.06281|||||||t-test, 2 sided|||||||0.062810
71092644|NCT05473039|141691743|SUPERIORITY|||||||0.417757|||||||t-test, 2 sided|||ALT at the start of COH compared to baseline ALT.||||0.417757
71092645|NCT05473039|141691743|SUPERIORITY|||||||0.968525|||||||t-test, 2 sided|||ALT at the start of COH compared to baseline ALT.||||0.968525
71092646|NCT05473039|141691744|SUPERIORITY|||||||0.686488|||||||t-test, 2 sided|||||||0.686488
71092647|NCT05473039|141691744|SUPERIORITY|||||||0.39512|||||||t-test, 2 sided|||Cholesterol at the start of COH compared to baseline cholesterol.||||0.395120
71092648|NCT05473039|141691744|SUPERIORITY|||||||0.127135|||||||t-test, 2 sided|||Cholesterol at the start of COH compared to baseline cholesterol.||||0.127135
71092649|NCT05473039|141691745|SUPERIORITY|||||||0.257496|||||||t-test, 2 sided|||||||0.257496
70912091|NCT03499600|141314204|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||||0.03|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. This linear regressions tested condition effects on caregiver perceptions of the extent to which the provider understood the caregivers' values or what is important to them.||||.03
70912092|NCT03499600|141314204|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||||0.68|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed.This linear regressions tested condition effects on caregiver satisfaction with the intake.||||.68
70912093|NCT03499600|141314204|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||||0.03|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed.This linear regressions tested condition effects on provider perceptions of the extent to which the provider understood the caregivers' values or what is important to them.||||.03
70912094|NCT03499600|141314204|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.|||||<|0.05|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. This linear regressions tested condition effects on provider satisfaction with the intake.||||<.05
70912095|NCT03499600|141314206|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||||0.93|||||||Regression, Linear|||Power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. Linear regressions tested condition effects on therapeutic alliance.||||.93
70912096|NCT03499600|141314206|SUPERIORITY|||||||0.9|||||||Regression, Linear|||Tested the moderation effects of language of service reception and condition on therapeutic alliance.||||.90
70912097|NCT03499600|141314207|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery. Baseline ECBI score was included as a covariate for the treatment response analyses.||||||0.171|||||||Regression, Logistic|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. A logistic regression tested condition effects on treatment response.||||.171
70912098|NCT03499600|141314207|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|||Testes the effects of the moderation of language of service delivery and condition on treatment response.||||<.05
70912099|NCT03499600|141314208|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||||0.38|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. Linear regressions tested condition effects on session attendance.||||.38
70912100|NCT03499600|141314208|SUPERIORITY|||||||0.01|||||||Regression, Linear|||Analyses tested the moderation of language of service delivery and condition on session attendance.||||.01
70912101|NCT03499600|141314208|SUPERIORITY|||||||0.56|||||||Regression, Linear|||Power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. linear regressions tested condition effects on homework completion. Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||.56
70912102|NCT03499600|141314208|SUPERIORITY||||||<|0.01|||||||Regression, Linear|||Analyses tested the moderation effect of language of service delivery and condition on homework completion.||||<.01
70912103|NCT03499600|141314208|SUPERIORITY|||||||0.4|||||||Regression, Logistic|||Power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. Logistic regressions tested condition effects on initial session attendance. Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||.40
70912104|NCT03499600|141314208|SUPERIORITY|||||||0.01|||||||Regression, Logistic|||Analyses tested the moderation of language of service delivery and condition on initial session attendance.||||.01
70912105|NCT03499600|141314208|SUPERIORITY|||||||0.03|||||||Regression, Logistic|||power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. A Logistic regression tested condition effects on completion of first treatment module. Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||.03
70912106|NCT03499600|141314208|SUPERIORITY|||||||0.03|||||||Regression, Logistic|||Analyses tested the moderation of language of service delivery and condition on completion of first treatment module.||||.03
70912107|NCT03499600|141314209|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||||0.854|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. linear regressions tested condition effects on treatment satisfaction.||||.854
70912108|NCT03499600|141314210|SUPERIORITY|||||||0.319|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. linear regressions tested change in ECBI score from baseline to post treatment.||||.319
70912109|NCT03425539|141314218|OTHER|An ANCOVA was applied to the change from baseline to Month 6 including the baseline value, the two stratification factors (sex and enzyme replacement therapy (ERT) treatment status), and the treatment group.|LS Mean difference vs. placebo|0.42||||0.3189|TWO_SIDED|95.0|-0.4|1.23|||ANCOVA|||||1.23|-0.4|0.3189
70912110|NCT03425539|141314219|OTHER|An ANCOVA was applied to the change from baseline to Month 6 including the baseline value, the two stratification factors (sex and ERT treatment status), and the treatment group.|LS Mean difference vs. placebo|-873.53|||<|0.0001|TWO_SIDED|95.0|-1097.53|-649.53|||ANCOVA|||||-649.53|-1097.53|<0.0001
70912111|NCT03425539|141314220|OTHER|An ANCOVA was applied to the change from baseline to Month 6 including the terms value, the two stratification factors (sex and ERT treatment status), and the treatment group.|LS Mean difference vs. placebo|0.31||||0.4676|TWO_SIDED|95.0|-0.53|1.16|||ANCOVA|||||1.16|-0.53|0.4676
70912112|NCT03425539|141314221|OTHER||Win ratio|1.0||||0.8986|TWO_SIDED|95.0|0.57|1.89|||ANCOVA|||The p-value was derived from a rank ANCOVA adjusted for the baseline value and stratified by sex and ERT treatment status.||1.89|0.57|0.8986
70912113|NCT02014558|141314228|OTHER||Slope|0.99|||||TWO_SIDED|90.0|0.788|1.19||||||Dose Proportionality (Single Dose / Day -2) was evaluated using the power model.||1.19|0.788|
70912114|NCT02014558|141314228|OTHER||Slope|1.22|||||TWO_SIDED|90.0|1.0|1.43||||||Dose Proportionality (Multiple Dose / Cycle 1 Day 15) was evaluated using the power model.||1.43|1.00|
70912115|NCT02014558|141314229|OTHER||Slope|0.808|||||TWO_SIDED|90.0|0.629|0.988||||||Dose Proportionality (Single Dose / Day -2) was evaluated using the power model.||0.988|0.629|
70912116|NCT02014558|141314229|OTHER||Slope|1.21|||||TWO_SIDED|90.0|1.02|1.41||||||Dose Proportionality (Multiple Dose / Cycle 1 Day 15) was evaluated using the power model.||1.41|1.02|
70912117|NCT02014558|141314267|OTHER||Geometric LS Mean Ratio|109.46|||||TWO_SIDED|90.0|49.82|240.48||||||Statistical Comparison of Midazolam Exposure after Administration of Midazolam Alone or Coadministered with Gilteritinib: The difference of least squares (LS) means of log-transformed pharmacokinetic parameters between midazolam alone and midazolam + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||240.48|49.82|
70912118|NCT02014558|141314268|OTHER||Geometric LS Mean Ratio|149.9||||||90.0|74.88|300.06||||||Statistical Comparison of Midazolam Exposure after Administration of Midazolam Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between 1-hydroxymidazolam alone and 1-hydroxymidazolam + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||300.06|74.88|
70912119|NCT02014558|141314269|OTHER||Geometric LS Mean Ratio|111.64|||||TWO_SIDED|90.0|69.54|179.25||||||Statistical Comparison of Midazolam Exposure after Administration of Midazolam Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between midazolam alone and midazolam + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||179.25|69.54|
70912120|NCT02014558|141314270|OTHER||Geometric LS Mean Ratio|123.47|||||TWO_SIDED|90.0|72.41|210.52||||||Statistical Comparison of Midazolam Exposure after Administration of Midazolam Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between 1-hydroxymidazolam/midazolam alone and 1-hydroxymidazolam/midazolam + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||210.52|72.41|
70912121|NCT02014558|141314275|OTHER||Geometric LS Mean Ratio|93.96|||||TWO_SIDED|90.0|75.29|117.26||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||117.26|75.29|
70912122|NCT02014558|141314276|OTHER||Geometric LS Mean Ratio|91.46|||||TWO_SIDED|90.0|74.6|112.12||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||112.12|74.60|
70912123|NCT02014558|141314277|OTHER||Geometric LS Mean Ratio|97.71|||||TWO_SIDED|90.0|74.19|128.7||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||128.70|74.19|
70912124|NCT02014558|141314280|OTHER||Geometric LS Mean Ratio|106.42|||||TWO_SIDED|90.0|85.28|132.81||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||132.81|85.28|
70912125|NCT02014558|141314282|OTHER||Geometric LS Mean Ratio|83.93|||||TWO_SIDED|90.0|46.53|151.39||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||151.39|46.53|
70912126|NCT02014558|141314284|OTHER||Geometric LS Mean Ratio|82.84|||||TWO_SIDED|90.0|40.25|170.48||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||170.48|40.25|
71092650|NCT02535312|141691750|OTHER|||||||0.08|||||||Log Rank|||||||0.08
71092651|NCT02535312|141691751|OTHER|||||||0.15|||||||Log Rank|||||||0.15
71092652|NCT03034967|141691774|OTHER|Emax|Median Posterior Difference|0.08|||||TWO_SIDED|90.0|0.0|0.66|||||Median posterior difference, 90 percent (%) credible interval for Placebo and Danirixin 5 mg has been presented.|4-parameter Emax model selected.||0.66|0.00|
70912127|NCT00672256|141314313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|||<|0.05||95.0|||||Paired t-test|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.05
71092653|NCT03034967|141691774|OTHER|Emax|Median Posterior Difference|0.61|||||TWO_SIDED|90.0|0.0|1.52|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|4-parameter Emax model||1.52|0.00|
70912128|NCT00672256|141314314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.104|||<|0.05||95.0|||||Paired t-test|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.05
70912129|NCT00672256|141314315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|||<|0.05||95.0|||||Paired t-test|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.05
70912130|NCT00672256|141314316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|||<|0.05||95.0|||||Paired t-test|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.05
70912131|NCT02072226|141314317|OTHER|Confidence Interval|Adjusted Risk Difference|-1.1|||||TWO_SIDED|95.0|-9.44|7.25||||||||7.25|-9.44|
70912132|NCT02072226|141314318|OTHER|Confidence Interval|Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.527|1.244||||||||1.244|0.527|
70912133|NCT02072226|141314319|OTHER|Confidence Interval|Odds Ratio (OR)|0.858|||||TWO_SIDED|95.0|0.529|1.393||||||||1.393|0.529|
70912134|NCT02072226|141314320|OTHER|Confidence Interval|difference in percentages|3.25|||||TWO_SIDED|95.0|0.75|7.38||||||||7.38|0.75|
70912135|NCT02072226|141314321|OTHER|Confidence Interval|difference in percentages|4.53|||||TWO_SIDED|95.0|-0.34|10.07||||||Any ICH within 36 hours reported by site||10.07|-0.34|
70912136|NCT02072226|141314321|OTHER|Confidence Interval|difference in percentages|3.87|||||TWO_SIDED|95.0|-1.23|9.49||||||Any ICH within 36 hours reported by central reader||9.49|-1.23|
70912137|NCT00810303|141314329|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe alone and free ezetimibe with single dose treatment of efavirenz.||||<0.05
70912138|NCT00810303|141314330|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe alone and free ezetimibe with single dose treatment of efavirenz.||||<0.05
70912139|NCT00810303|141314332|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz without chronic treatment of ezetimibe.||||<0.05
70912140|NCT00810303|141314333|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz with chronic treatment of ezetimibe.||||<0.05
70912141|NCT00810303|141314334|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz without chronic treatment of ezetimibe.||||<0.05
71092654|NCT03034967|141691774|OTHER|Emax|Median Posterior Difference|1.25|||||TWO_SIDED|90.0|0.43|1.97|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|4-parameter Emax model selected.||1.97|0.43|
70912142|NCT00810303|141314334|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz with chronic treatment of ezetimibe.||||<0.05
70912143|NCT00810303|141314335|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz without chronic treatment of ezetimibe.||||<0.05
70912144|NCT00810303|141314336|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetics of efavirenz with chronic treatment of ezetimibe.||||<0.05
70912145|NCT00810303|141314337|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz without chronic treatment of ezetimibe.||||<0.05
70912146|NCT00810303|141314337|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetics of efavirenz with chronic treatment of ezetimibe.||||<0.05
70912147|NCT00810303|141314338|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe alone and free ezetimibe with single dose treatment of efavirenz.||||<0.05
70912148|NCT00810303|141314338|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe alone.||||<0.05
70912149|NCT00810303|141314339|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe alone and free ezetimibe with single dose treatment of efavirenz.||||<0.05
70912150|NCT00810303|141314339|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe with single dose treatment of efavirenz.||||<0.05
70912151|NCT00810303|141314340|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe alone.||||<0.05
70912152|NCT00810303|141314340|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe with single dose treatment of efavirenz.||||<0.05
71092655|NCT03034967|141691774|OTHER|Emax|Median Posterior Difference|1.34|||||TWO_SIDED|90.0|0.72|2.03|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|4-parameter Emax model selected.||2.03|0.72|
71092656|NCT03034967|141691774|OTHER|Emax|Median Posterior Difference|1.38|||||TWO_SIDED|90.0|0.79|2.07|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|4-parameter Emax model selected.||2.07|0.79|
70912153|NCT00810303|141314341|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe alone.||||<0.05
70912154|NCT00810303|141314342|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe with single dose treatment of efavirenz.||||<0.05
70912155|NCT00810303|141314343|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe alone.||||<0.05
70912156|NCT00810303|141314343|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe with single dose treatment of efavirenz.||||<0.05
70912157|NCT03635112|141314346|SUPERIORITY||Least Square Mean Difference|-0.76||||0.97|TWO_SIDED|95.0|-40.62|39.11|||Mixed Model Repeated Measures Analysis|||||39.11|-40.62|0.970
70912158|NCT03635112|141314346|SUPERIORITY||Least Square Mean Difference|-13.13||||0.51|TWO_SIDED|95.0|-52.46|26.19|||Mixed Model Repeated Measures Analysis|||||26.19|-52.46|0.510
70912159|NCT03635112|141314347|SUPERIORITY||Difference in Proportion|-0.07||||0.5102|TWO_SIDED|95.0|-0.277|0.135|||Cochran-Mantel-Haenszel Chi-square Test|||||0.135|-0.277|0.5102
70912160|NCT03635112|141314347|SUPERIORITY||Difference in Proportion|0.02||||0.8591|TWO_SIDED|95.0|-0.181|0.218|||Cochran-Mantel-Haenszel Chi-square Test|||||0.218|-0.181|0.8591
70912161|NCT03635112|141314348|SUPERIORITY||Difference in Proportion|-0.13||||0.1805|TWO_SIDED|95.0|-0.322|0.061|||Cochran-Mantel-Haenszel Chi-square Test|||||0.061|-0.322|0.1805
70912162|NCT03635112|141314348|SUPERIORITY||Difference in Proportion|-0.01||||0.9215|TWO_SIDED|95.0|-0.204|0.184|||Cochran-Mantel-Haenszel Chi-square Test|||||0.184|-0.204|0.9215
70912163|NCT03635112|141314349|SUPERIORITY||Least Square Mean Difference|1.6||||0.316|TWO_SIDED|95.0|-1.6|4.8|||ANCOVA|||||4.8|-1.6|0.316
70912164|NCT03635112|141314349|SUPERIORITY||Least Square Mean Difference|0.0||||0.988|TWO_SIDED|95.0|-3.2|3.2|||ANCOVA|||||3.2|-3.2|0.988
70912165|NCT03635112|141314350|SUPERIORITY||Difference in Proportion|-0.11||||0.1828|TWO_SIDED|95.0|-0.27|0.059|||Cochran-Mantel-Haenszel Chi-square Test|||||0.059|-0.270|0.1828
70912166|NCT03635112|141314350|SUPERIORITY||Difference in Proportion|0.06||||0.5785|TWO_SIDED|95.0|-0.133|0.244|||Cochran-Mantel-Haenszel Chi-square Test|||||0.244|-0.133|0.5785
70912167|NCT03635112|141314351|SUPERIORITY||Difference in Proportion|-0.07||||0.3776|TWO_SIDED|95.0|-0.225|0.095|||Cochran-Mantel-Haenszel Chi-square Test|||||0.095|-0.225|0.3776
70912168|NCT03635112|141314351|SUPERIORITY||Difference in Proportion|-0.04||||0.6063|TWO_SIDED|95.0|-0.189|0.111|||Cochran-Mantel-Haenszel Chi-square Test|||||0.111|-0.189|0.6063
70912169|NCT03006341|141314357|OTHER||C-Statistic|0.81|||||||||||Regression, Logistic|Logistic regression with bleeding history or predisposition as dependent and treatment groups and claims based variables as the independent variables|The C-statistic can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|"The concordance statistic is equal to the area under a receiver operating characteristic (ROC) curve. The C-statistic (sometimes called the concordance statistic or C-index) is a measure of goodness of fit for binary outcomes in a logistic regression model."||||
70912170|NCT03006341|141314359|OTHER||Adjusted R squared statistic|0.02|||||||||||Regression, Linear|Logistic regression model with serum creatinine as the dependent variable and treatment groups and claims based variables as the independent variables|The adjusted R² statistic, or coefficient of determination, is the proportion of the variance in the (EMR) outcome that is predictable from the independent (claims) variables, adjusted for the number of predictors in the model.|R-squared is a statistical measure of how close the data are to the fitted regression line. 0% indicates that the model explains none of the variability of the response data around its mean. 100% indicates that the model explains all the variability of the response data around its mean.||||
70912171|NCT03006341|141314361|OTHER||Adjusted R squared statistic|0.04|||||||||||Regression, Linear|Linear regression model with duration of atrial fibrillation as dependent and treatment groups and claims based variables as independent variables|The adjusted R² statistic, or coefficient of determination, is the proportion of the variance in the (EMR) outcome that is predictable from the independent (claims) variables, adjusted for the number of predictors in the model.|R-squared is a statistical measure of how close the data are to the fitted regression line. 0% indicates that the model explains none of the variability of the response data around its mean. 100% indicates that the model explains all the variability of the response data around its mean.||||
70912172|NCT03006341|141314367|OTHER||C-Statistic|0.88|||||||||||Regression, Logistic|Logistic regression model with diabetes as the dependent variable and treatment groups and claims based variables as the independent variables.|The C-statistic can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|"The concordance statistic is equal to the area under a ROC curve. The C-statistic (sometimes called the concordance statistic or C-index) is a measure of goodness of fit for binary outcomes in a logistic regression model."||||
70912173|NCT03006341|141314368|OTHER||C-Statistic|0.69|||||||||||Regression, Logistic|Logistic regression model with hyperlipidemia as the dependent variable and treatment groups and claims based variables as the independent variables.|The C-statistic can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|"The concordance statistic is equal to the area under a ROC curve. The C-statistic (sometimes called the concordance statistic or C-index) is a measure of goodness of fit for binary outcomes in a logistic regression model."||||
70912174|NCT03006341|141314369|OTHER||Adjusted R squared statistic|0.34|||||||||||Regression, Linear|Linear regression model with HAS-BLED score as the dependent variable and treatment groups and claims based variables as the independent variables.|The adjusted R² statistic, or coefficient of determination, is the proportion of the variance in the (EMR) outcome that is predictable from the independent (claims) variables, adjusted for the number of predictors in the model.|R-squared is a statistical measure of how close the data are to the fitted regression line. 0% indicates that the model explains none of the variability of the response data around its mean. 100% indicates that the model explains all the variability of the response data around its mean.||||
70912175|NCT03101592|141314371|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|4.0|||||TWO_SIDED|95.0|-4.3|12.3|||||RD is for retention 3MD vs. SOC.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||12.3|-4.3|
70912176|NCT03101592|141314371|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|9.1|||||TWO_SIDED|95.0|0.9|17.2|||||RD is for retention 6MD vs. SOC.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||17.2|0.9|
70912177|NCT03101592|141314371|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|1.0|9.1|||||RD is for retention 6MD vs. 3MD.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||9.1|1|
70912178|NCT03101592|141314371|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-0.8|1.6|||||RD is for transfer 3MD vs. SOC.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||1.6|-0.8|
70912179|NCT03101592|141314371|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.9|0.8|||||RD is for transfer 6MD vs. SOC.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||0.8|-0.9|
70912180|NCT03101592|141314371|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|-0.5|||||TWO_SIDED|95.0|-1.7|0.7|||||RD is for transfer 6MD vs. 3MD.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||0.7|-1.7|
70912181|NCT03101592|141314371|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.4|0.2|||||RD is for death 3MD vs. SOC.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||0.2|-0.4|
70912182|NCT03101592|141314371|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.9|0.8|||||RD is for death 6MD vs. SOC.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||0.8|-0.9|
70970609|NCT00531752|141447058|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2007|STANDARD_ERROR_OF_MEAN|3.9647||0.7631|TWO_SIDED|80.0|-3.941|6.3423|||Mixed Models Analysis|||Week 3 (PDF): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.3423|-3.941|0.7631
71092657|NCT03034967|141691775|OTHER|Emax|Median Posterior Difference|0.09|||||TWO_SIDED|90.0|0.0|0.42|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 5 mg has been presented.|4-parameter Emax model selected.||0.42|0.00|
71092658|NCT03034967|141691775|OTHER|Emax|Median Posterior Difference|0.43|||||TWO_SIDED|90.0|0.0|0.87|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|4-parameter Emax model||0.87|0.00|
70912183|NCT03101592|141314371|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-0.3|0.3|||||RD is for death 6MD vs. 3MD.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||0.3|-0.3|
70912184|NCT01770860|141314375|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-values presented were for each of the bandage groups compared to no treatment group.|Mixed Models Analysis|P-value is from mixed model with Treatment (trt) as fix effect, and subject as random effect.||||||<0.0001
70912185|NCT01770860|141314376|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-values presented were for each of the bandage groups compared to no treatment group.|Mixed Models Analysis|P-value is from mixed model with treatment (trt) as fix effect, and subject as random effect.||||||<0.0001
70912186|NCT01770860|141314377|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-values presented were for each of the bandage groups compared to no treatment group.|Mixed Models Analysis|P-value is from mixed model with treatment (trt) as fix effect, and subject as random effect.||||||<0.0001
70912187|NCT01770860|141314378|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-values presented were for each of the bandage groups compared to no treatment group.|Mixed Models Analysis|P-value is from mixed model with treatment (trt) as fix effect, and subject as random effect.||||||<0.0001
70912188|NCT01770860|141314379|SUPERIORITY_OR_OTHER|||||||0.0476|||||||Mixed Models Analysis|P-value is from mixed model with treatment (trt) as fix effect, and subject as random effect||||||0.0476
70912189|NCT02341534|141314382|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.21|TWO_SIDED|95.0|0.64|1.1|||Log Rank|||||1.10|0.64|0.21
70912190|NCT00601640|141314400|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Fisher Exact|||||||0.022
70912191|NCT03419780|141314412|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70912192|NCT03419780|141314413|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
70912193|NCT03419780|141314414|SUPERIORITY|||||||0.89|||||||Chi-squared|||||||0.89
70912194|NCT03419780|141314415|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||||||0.34
70912195|NCT03419780|141314416|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
70912196|NCT03419780|141314417|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
70912197|NCT03419780|141314418|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.00
70912198|NCT01872611|141314419|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.2||0.671|TWO_SIDED|95.0|0.7|1.3|||Regression, Logistic||Parameter dispersion is the standard error for the odds ratio.|This endpoint was considered primary for United States (US) registration and secondary for European Union (EU) registration.||1.3|0.7|0.671
70912199|NCT01872611|141314420|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|0.2|0.7|||Regression, Logistic||Parameter dispersion is the standard error for the odds ratio.|This endpoint was considered primary for EU registration and secondary for US registration.||0.7|0.2|0.001
70912200|NCT05096117|141314463|SUPERIORITY||Least Square Mean Difference|0.178||||0.784|TWO_SIDED||||||ANCOVA|||||||0.784
70912201|NCT01446003|141314488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.02|||||TWO_SIDED|90.0|-0.52|4.56|||Linear mixed effect models|The model contained period and treatment as fixed effect, Day -1 baseline as a fixed continuous covariate, and participant as random effect.||If the upper limit of the 90% confidence interval lies below the bound 5 mmHg, the hypothesis that change from baseline in ambulatory 24-hour mean SBP in participants with mild to moderate hypertension following 10 days of multiple dosing of MK-8457 is similar to placebo will be supported.||4.56|-0.52|
70912202|NCT01446003|141314489|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.57|||||TWO_SIDED|90.0|0.19|2.96|||Linear mixed effects model|The model contained period and treatment as fixed effect, Day -1 baseline as a fixed continuous covariate, and participant as random effect.||||2.96|0.19|
70912203|NCT01446003|141314490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9|||||TWO_SIDED|90.0|2.44|13.35|||Linear mixed effects model|The model contained period and treatment as fixed effect, Day -1 baseline as a fixed continuous covariate, and participant as random effect.||Treatment comparison of maxMAΔ in SBP from baseline to Day 10 after AM dosing||13.35|2.44|
70912204|NCT01446003|141314490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|||||TWO_SIDED|90.0|-5.68|3.81|||Linear mixed effects model|The model contained period and treatment as fixed effect, Day -1 baseline as a fixed continuous covariate, and participant as random effect.||Treatment comparison of maxMAΔ in SBP from baseline to Day 10 after PM dosing||3.81|-5.68|
70912205|NCT01446003|141314490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.26|||||TWO_SIDED|90.0|0.81|9.71|||Linear mixed effects model|The model contained period and treatment as fixed effect, Day -1 baseline as a fixed continuous covariate, and participant as random effect.||Treatment comparison of maxMAΔ in DBP from baseline to Day 10 after AM dosing||9.71|0.81|
70912206|NCT01446003|141314490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69|||||TWO_SIDED|90.0|-4.55|1.17|||Linear mixed effects model|The model contained period and treatment as fixed effect, Day -1 baseline as a fixed continuous covariate, and participant as random effect.||Treatment comparison of maxMAΔ in DBP from baseline to Day 10 after PM dosing||1.17|-4.55|
70912207|NCT00318656|141314497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.02|STANDARD_ERROR_OF_MEAN|2.49||0.064||95.0|-0.32|10.36|||ANCOVA|Analysis of covariance (ANCOVA)|Mean Difference =(Rosiglitazone + Met) - (Glimepiride+Met)|Statistical analysis was based off of week 12 results.||10.36|-0.32|0.064
70912208|NCT00318656|141314498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|1.45||0.923||95.0|-3.37|2.85||P value von elteren (adjusted on sex)|ANCOVA||Mean Difference =(Rosiglitazone + Met) - (Glimepiride+Met)|Statistical analysis was based off of week 12 results.||2.85|-3.37|0.923
70912209|NCT02806895|141314553|SUPERIORITY|||||||0.0062|||||||ANOVA|||||||0.0062
70912210|NCT02806895|141314554|SUPERIORITY|||||||0.0432|||||||ANOVA|||||||0.0432
70912211|NCT02806895|141314555|SUPERIORITY|||||||0.0414|||||||McNemar|||||||0.0414
70912212|NCT02806895|141314556|SUPERIORITY|||||||0.0963|||||||McNemar|||||||0.0963
70912213|NCT02806895|141314557|SUPERIORITY|||||||0.1435|||||||McNemar|||||||0.1435
70912214|NCT02806895|141314558|SUPERIORITY|||||||0.1796|||||||McNemar|||||||0.1796
70912215|NCT02806895|141314559|SUPERIORITY|||||||0.1094|||||||McNemar|||||||0.1094
70912216|NCT02806895|141314560|SUPERIORITY|||||||0.4531|||||||McNemar|||||||0.4531
70912217|NCT02806895|141314561|SUPERIORITY|||||||0.3593|||||||McNemar|||||||0.3593
70912218|NCT02806895|141314562|SUPERIORITY|||||||0.6072|||||||McNemar|||||||0.6072
70912219|NCT02806895|141314563|SUPERIORITY|||||||0.7905|||||||McNemar|||||||0.7905
70912220|NCT02806895|141314564|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
70912221|NCT02806895|141314565|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
70912222|NCT02806895|141314566|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
70912223|NCT02806895|141314567|SUPERIORITY|||||||0.4116|||||||ANOVA|||||||0.4116
70912224|NCT02806895|141314568|SUPERIORITY|||||||0.1991|||||||ANOVA|||||||0.1991
70912225|NCT02806895|141314569|SUPERIORITY|||||||0.0806|||||||ANOVA|||||||0.0806
70912226|NCT02806895|141314570|SUPERIORITY|||||||0.9391|||||||ANOVA|||||||0.9391
70912227|NCT02806895|141314571|SUPERIORITY|||||||0.2116|||||||ANOVA|||||||0.2116
70912228|NCT02806895|141314572|SUPERIORITY|||||||0.1604|||||||ANOVA|||||||0.1604
70912229|NCT02806895|141314573|SUPERIORITY|||||||0.2144|||||||ANOVA|||||||0.2144
70912230|NCT02806895|141314574|SUPERIORITY|||||||0.0387|||||||ANOVA|||||||0.0387
70912231|NCT02806895|141314575|SUPERIORITY|||||||0.3426|||||||ANOVA|||||||0.3426
70912232|NCT02806895|141314576|SUPERIORITY|||||||0.1531|||||||ANOVA|||||||0.1531
70912233|NCT02806895|141314577|SUPERIORITY|||||||0.5603|||||||ANOVA|||||||0.5603
70912234|NCT02806895|141314578|SUPERIORITY|||||||0.4851|||||||ANOVA|||||||0.4851
70912235|NCT02806895|141314579|SUPERIORITY|||||||0.0241|||||||ANOVA|||||||0.0241
70912236|NCT00601965|141314583|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Log rank test = 32.67, df = 3||||||<.001
70912237|NCT00601965|141314584|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mixed Models Analysis|Beta = -0.48, 95% CI = -0.84 to -0.11||||||0.01
70912238|NCT02735187|141314585|SUPERIORITY|A paired t-test was applied to test the primary hypothesis. In case the requirements for normality were not met, a non-parametric analysis (Wilcoxon signed rank test) was performed.||||||0.6469||||||A probability (P-Value) above 0.05 is considered not to be statistical significant.|t-test, 2 sided|||||||0.6469
70912239|NCT05750745|141314632|SUPERIORITY||Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.096||0.0871|TWO_SIDED|95.0|-0.36|0.02|||Mixed Model with Repeated Measure (MMRM)||Adjusted mean difference was calculated as test minus negative control.|||0.02|-0.36|0.0871
70912240|NCT05750745|141314633|SUPERIORITY||Adjusted Mean Difference|6.21|STANDARD_ERROR_OF_MEAN|3.548||0.0972|TWO_SIDED|95.0|-0.78|13.2|||van Elteren Test|P-value was from the van Elteren test adjusted for Baseline Schiff sensitivity stratification factor.|Adjusted mean difference was calculated as test minus negative control.|||13.20|-0.78|0.0972
70912241|NCT05750745|141314634|SUPERIORITY||Adjusted Mean Difference|-5.81|STANDARD_ERROR_OF_MEAN|3.16||0.0671|TWO_SIDED|95.0|-12.04|0.41|||MMRM||Adjusted mean difference was calculated as test minus negative control.|||0.41|-12.04|0.0671
70912242|NCT05750745|141314635|SUPERIORITY||Adjusted Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.0673|TWO_SIDED|95.0|-0.27|0.01|||MMRM||Adjusted mean difference was calculated as test minus negative control.|||0.01|-0.27|0.0673
70912243|NCT05750745|141314636|SUPERIORITY||Adjusted Mean Difference|2.38|STANDARD_ERROR_OF_MEAN|2.446||0.405|TWO_SIDED|95.0|-2.44|7.2|||van Elteren Test|P-value was from the van Elteren test adjusted for Baseline Schiff sensitivity stratification factor.|Adjusted mean difference was calculated as test minus negative control.|||7.20|-2.44|0.4050
70912244|NCT05750745|141314637|SUPERIORITY||Adjusted Mean Difference|-5.64|STANDARD_ERROR_OF_MEAN|2.656||0.0346|TWO_SIDED|95.0|-10.88|-0.41|||MMRM||Adjusted mean difference was calculated as test minus negative control.|||-0.41|-10.88|0.0346
70912245|NCT05750745|141314638|SUPERIORITY||Adjusted Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.085||0.8256|TWO_SIDED|95.0|-0.15|0.19|||MMRM||Adjusted mean difference was calculated as positive control minus negative control.|Change from Baseline at Week 6||0.19|-0.15|0.8256
70912246|NCT05750745|141314638|SUPERIORITY||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.117||0.5314|TWO_SIDED|95.0|-0.16|0.3|||MMRM||Adjusted mean difference was calculated as positive control minus negative control.|Change from Baseline at Week 12||0.30|-0.16|0.5314
70912247|NCT05750745|141314639|SUPERIORITY||Adjusted Mean Difference|-2.59|STANDARD_ERROR_OF_MEAN|2.99||0.5575|TWO_SIDED|95.0|-8.48|3.3|||van Elteren Test|P-value was from the Van Elteren test adjusted for Baseline Schiff sensitivity stratification factor.|Adjusted mean difference was calculated as positive control minus negative control.|Change from Baseline at Week 6||3.30|-8.48|0.5575
70912248|NCT05750745|141314639|SUPERIORITY||Adjusted Mean Difference|-1.12|STANDARD_ERROR_OF_MEAN|4.308||0.7717|TWO_SIDED|95.0|-9.6|7.37|||van Elteren Test|P-value was from the van Elteren test adjusted for Baseline Schiff sensitivity stratification factor.|Adjusted mean difference was calculated as positive control minus negative control.|Change from Baseline at Week 12||7.37|-9.60|0.7717
70912249|NCT05750745|141314640|SUPERIORITY||Adjusted Mean Difference|0.75|STANDARD_ERROR_OF_MEAN|3.235||0.818|TWO_SIDED|95.0|-5.63|7.12|||MMRM||Adjusted mean difference was calculated as positive control minus negative control.|Change from Baseline at Week 6||7.12|-5.63|0.8180
70912250|NCT05750745|141314640|SUPERIORITY||Adjusted Mean Difference|3.73|STANDARD_ERROR_OF_MEAN|3.834||0.3322|TWO_SIDED|95.0|-3.83|11.28|||MMRM||Adjusted mean difference was calculated as positive control minus negative control.|Change from Baseline at Week 12||11.28|-3.83|0.3322
70912251|NCT00783692|141314659|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.8||||0.0206|TWO_SIDED|95.0|1.2|14.3||P-value is based on the Cochran-Mantel-Haenszel (CMH) chi-square test, with stratification according to: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no).|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|The Hochberg method was applied to control the overall Type I error rate at a 5% significance level for the multiple comparisons of the primary endpoints. If both p-values were ≤ 0.05, both primary endpoints were to be declared significant. If 1 of the p-values for the primary endpoints was \> 0.05, the other p-value was to be tested at the 0.025 level and declared significant only if the p-value was ≤ 0.025. If neither primary was declared significant, no further testing was to be conducted.||14.3|1.2|0.0206
70912252|NCT00783692|141314660|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.7||||0.2322|TWO_SIDED|95.0|-3.6|15.0||P-value is based on the Cochran-Mantel-Haenszel (CMH) chi-square test, with stratification according to: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no).|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|The Hochberg method was applied to control the overall Type I error rate at a 5% significance level for the multiple comparisons of the primary endpoints. If both p-values were ≤ 0.05, both primary endpoints were to be declared significant. If 1 of the p-values for the primary endpoints was \> 0.05, the other p-value was to be tested at the 0.025 level and declared significant only if the p-value was ≤ 0.025. If neither primary was declared significant, no further testing was to be conducted.||15.0|-3.6|0.2322
70912253|NCT00783692|141314661|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.4||||0.0007|TWO_SIDED|95.0|7.3|27.5||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|The Hochberg method was applied to control the overall Type I error rate at a 5% significance level. If both p-values were ≤ 0.05, both dose regimens were to be declared significant. If 1 of the p-values for the 2 dose comparisons was \> 0.05, the other p-value was to be tested at the 0.025 level and declared significant only if the p-value was ≤ 0.025. If neither dose was declared significant for the primary endpoint, no further testing was to be conducted.||27.5|7.3|0.0007
70912254|NCT00783692|141314661|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.7||||0.0042|TWO_SIDED|95.0|4.6|24.7||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|The Hochberg method was applied to control the overall Type I error rate at a 5% significance level. If both p-values were ≤ 0.05, both dose regimens were to be declared significant. If 1 of the p-values for the 2 dose comparisons was \> 0.05, the other p-value was to be tested at the 0.025 level and declared significant only if the p-value was ≤ 0.025. If neither dose was declared significant for the primary endpoint, no further testing was to be conducted.||24.7|4.6|0.0042
70912255|NCT00783692|141314662|SUPERIORITY_OR_OTHER|||||||0.9288||||||Wilcoxon Rank Sum test on the CRP change from baseline values (two-sided).|Wilcoxon (Mann-Whitney)|||If at least 1 of the primary endpoints was significant, the sequential Hochberg procedure was to be used to test the secondary endpoint for significance at the 0.05% level.||||0.9288
70912256|NCT00783692|141314663|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.4||||0.0132|TWO_SIDED|95.0|2.8|24.0||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.||24.0|2.8|0.0132
70912257|NCT00783692|141314663|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.3||||0.0053|TWO_SIDED|95.0|4.6|26.0||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.||26.0|4.6|0.0053
70912258|NCT00783692|141314664|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.9||||0.0154|TWO_SIDED|95.0|3.0|28.7||P-value is based on the CMH chi-square test, with stratification according to: 1) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 2) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.||28.7|3.0|0.0154
70912259|NCT00783692|141314664|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.9||||0.045|TWO_SIDED|95.0|0.3|25.5||P-value is based on the CMH chi-square test, with stratification according to: 1) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 2) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.||25.5|0.3|0.0450
70850341|NCT02657408|141188420|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|0.94|||||TWO_SIDED|90.0|0.8|1.09||||||The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.09|0.80|
71092659|NCT03034967|141691775|OTHER|Emax|Median Posterior Difference|0.68|||||TWO_SIDED|90.0|0.23|1.08|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|4-parameter Emax model selected.||1.08|0.23|
71092660|NCT03034967|141691775|OTHER|Emax|Median Posterior Difference|0.72|||||TWO_SIDED|90.0|0.37|1.1|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|4-parameter Emax model selected.||1.10|0.37|
71092661|NCT03034967|141691775|OTHER|Emax|Median Posterior Difference|0.73|||||TWO_SIDED|90.0|0.4|1.12|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|4-parameter Emax model selected.||1.12|0.40|
71092662|NCT03034967|141691776|OTHER|Emax|Median Posterior Difference|0.01|||||TWO_SIDED|90.0|0.0|0.16|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 5 mg has been presented.|4-parameter Emax model selected.||0.16|0.00|
71092663|NCT03034967|141691776|OTHER|Emax|Median Posterior Difference|0.12|||||TWO_SIDED|90.0|0.0|0.43|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|4-parameter Emax model||0.43|0.00|
71092664|NCT03034967|141691776|OTHER|Emax|Median Posterior Difference|0.38|||||TWO_SIDED|90.0|0.04|0.61|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|4-parameter Emax model selected.||0.61|0.04|
71092665|NCT03034967|141691776|OTHER|Emax|Median Posterior Difference|0.42|||||TWO_SIDED|90.0|0.21|0.64|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|4-parameter Emax model selected.||0.64|0.21|
71092666|NCT03034967|141691776|OTHER|Emax|Median Posterior Difference|0.45|||||TWO_SIDED|90.0|0.26|0.66|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|4-parameter Emax model selected.||0.66|0.26|
71092667|NCT03034967|141691777|OTHER|Log-linear|Median Posterior Difference|0.01|||||TWO_SIDED|90.0|-0.21|0.23|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 5 mg has been presented.|Log-linear model.||0.23|-0.21|
71092668|NCT03034967|141691777|OTHER|Log-linear|Median Posterior Difference|0.01|||||TWO_SIDED|90.0|-0.23|0.25|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|Log-linear model||0.25|-0.23|
71092669|NCT03034967|141691777|OTHER|Log-linear|Median Posterior Difference|0.01|||||TWO_SIDED|90.0|-0.27|0.29|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|Log-linear model||0.29|-0.27|
71092670|NCT03034967|141691777|OTHER|Log-linear|Median Posterior Difference|0.01|||||TWO_SIDED|90.0|-0.28|0.3|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|Log-linear model||0.30|-0.28|
71092671|NCT03034967|141691777|OTHER|Log-linear|Median Posterior Difference|0.01|||||TWO_SIDED|90.0|-0.29|0.31|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|Log-linear model||0.31|-0.29|
71092672|NCT03034967|141691784|OTHER||Odds Ratio (OR)|1.71||||0.089|TWO_SIDED|90.0|1.02|2.86||Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.|linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.|||2.86|1.02|0.089
71092673|NCT03034967|141691784|OTHER||Odds Ratio (OR)|1.05||||0.881|TWO_SIDED|90.0|0.62|1.79||Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.|linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|||1.79|0.62|0.881
70850342|NCT02657408|141188421|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|0.81|||||TWO_SIDED|90.0|0.51|1.28||||||The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.28|0.51|
71092674|NCT03034967|141691784|OTHER||Odds Ratio (OR)|0.87||||0.674|TWO_SIDED|90.0|0.51|1.48||Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.|linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|||1.48|0.51|0.674
71092675|NCT03034967|141691784|OTHER||Odds Ratio (OR)|0.92||||0.804|TWO_SIDED|90.0|0.54|1.58||Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.|linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|||1.58|0.54|0.804
71092676|NCT03034967|141691784|OTHER||Odds Ratio (OR)|1.01||||0.987|TWO_SIDED|90.0|0.59|1.71||Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.|linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|||1.71|0.59|0.987
71092677|NCT03034967|141691786|OTHER||Median Posterior Hazard Ratio|1.2|||||TWO_SIDED|90.0|0.5|2.6|||||Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.||DNX versus (vs.) Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted Forced Expiratory Volume in one second (FEV1)at Screening.|2.6|0.5|
71092678|NCT03034967|141691786|OTHER||Median Posterior Hazard Ratio|1.0|||||TWO_SIDED|90.0|0.4|2.4|||||Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|2.4|0.4|
71092679|NCT03034967|141691786|OTHER||Median Posterior Hazard Ratio|1.4|||||TWO_SIDED|90.0|0.6|3.2|||||Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|3.2|0.6|
70912260|NCT00783692|141314665|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.2||||0.1036|TWO_SIDED|95.0|-1.5|16.0||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.||16.0|-1.5|0.1036
70912261|NCT00783692|141314665|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.0||||0.6413|TWO_SIDED|95.0|-6.3|10.2||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.||10.2|-6.3|0.6413
70912262|NCT03568162|141314701|SUPERIORITY|The analysis was conducted using a mixed model for repeated measures (MMRM) model for percent change from baseline in EASI with the corresponding baseline value as covariate, and treatment group, region, disease severity, visit as fixed effect factors, and interactions of treatment-by-visit, baseline-by-visit|LS Mean Difference|-20.192|STANDARD_ERROR_OF_MEAN|7.4781|=|0.008|TWO_SIDED|95.0|-34.944|5.439|||Mixed Models Analysis||A linear contrast was used to estimate the treatment difference|||5.439|-34.944|= 0.008
70912263|NCT03568162|141314701|SUPERIORITY|The analysis was conducted using a MMRM model for percent change from baseline in EASI with the corresponding baseline value as covariate, and treatment group, region, disease severity, visit as fixed effect factors, and interactions of treatment-by-visit, baseline-by-visit.|LS Mean Difference|-14.439|STANDARD_ERROR_OF_MEAN|7.6622|=|0.061|TWO_SIDED|95.0|-29.552|0.674|||Mixed Models Analysis||A linear contrast was used to estimate the treatment difference|||0.674|-29.552|= 0.061
70912264|NCT03568162|141314701|SUPERIORITY|The analysis was conducted using a mixed MMRM model for percent change from baseline in EASI with the corresponding baseline value as covariate, and treatment group, region, disease severity, visit as fixed effect factors, and interactions of treatment-by-visit, baseline-by-visit.|LS Mean Difference|3.144|STANDARD_ERROR_OF_MEAN|7.8864|=|0.691|TWO_SIDED|95.0|-12.41|18.698|||Mixed Models Analysis||A linear contrast was used to estimate the treatment difference.|||18.698|-12.410|= 0.691
70912265|NCT03568162|141314701|SUPERIORITY||LS Mean Difference|-17.199|STANDARD_ERROR_OF_MEAN|6.409|=|0.008|TWO_SIDED|95.0|-29.895|-4.503|||Mixed Models Analysis||A linear contrast was used to estimate the treatment difference.|The analysis was conducted using a MMRM model for percent change from baseline in EASI with the corresponding baseline value as covariate, and treatment group, region, disease severity, visit as fixed effect factors, and interactions of treatment-by-visit, baseline-by-visit.||-4.503|-29.895|= 0.008
70912266|NCT02081391|141314752|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.02||0.0404|TWO_SIDED|95.0|-0.09|0.0|||ANOVA|||The endpoint was analyzed using an analysis of variance model. This included treatment, baseline age group, and the used SOAM as factors. For participants discontinuing treatment before 12 hours for any other reason than no further need of opioid analgesics or switch to exclusively oral opioid analgesics, cumulative SOAM use over the respective time period was based on the observed SOAM use up to the time of the participant's discontinuation.||0|-0.09|0.0404
70912267|NCT02081391|141314753|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.0154|TWO_SIDED|95.0|-0.18|-0.02|||ANOVA|||The endpoint was analyzed using an analysis of variance model. This included treatment, baseline age group, and the used supplemental opioid analgesic medication (SOAM) as factors. For participants discontinuing treatment before 24 hours for any other reason than no further need of SOAM or switch to exclusively oral opioid analgesics, cumulative SOAM use over the respective time period was based on the observed SOAM use up to the time of the participant's discontinuation.||-0.02|-0.18|0.0154
70912268|NCT00126113|141314778|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|Analysis for main effect of group||||||>0.05
70912269|NCT00126113|141314779|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Analysis for main effect of group|ANOVA|||||||>0.05
70912270|NCT00126113|141314780|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|Analysis for main effect of group||||||>0.05
70912271|NCT00126113|141314781|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|Analysis for main effect of group||||||>0.05
70912272|NCT03860077|141314787|SUPERIORITY|Average cigarettes per day was positively skewed, with a non-normal residual distribution in a mixed model analysis specifying a normal (Gaussian) outcome distribution. Therefore, this outcome was recoded to integers and modeled as a count with a negative binomial distribution and log link. The focal test is the difference in change from Baseline to Week 4 (i.e., Time) in the VLNC vs. NNC condition (i.e., Group), which is a cross-level interactive effect of Time and Group.|Risk Ratio (RR)|1.42|STANDARD_ERROR_OF_MEAN|0.21||0.111|TWO_SIDED|95.0|0.92|2.19|||Mixed Models Analysis||The reported value is the standard error of the mean for the non-exponentiated estimate = 0.35.|These are results of a 2-group (VLNC \& NNC) x 2 repeated measures (Baseline \& Week 4) mixed effects model to test the effect of the randomization group (VLNC vs. NNC) on change in cigarette use and alternative tobacco product (ATP) use from Baseline to Week 4. Group (VLNC vs. NNC) is a fixed, between-subjects focal predictor. Timepoint (Baseline vs. Week 4) is a fixed, within-subjects repeated measure. Subject is a random effect, accounting for variability in Baseline cigarette and ATP use.||2.19|0.92|.111
71092680|NCT03034967|141691786|OTHER||Median Posterior Hazard Ratio|2.0|||||TWO_SIDED|90.0|1.0|4.3|||||Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|4.3|1.0|
70912273|NCT03860077|141314788|SUPERIORITY||Odds Ratio (OR)|0.71|STANDARD_ERROR_OF_MEAN|0.93||0.721|TWO_SIDED|95.0|0.11|4.75|||Mixed Models Analysis||The reported value is the standard error of the mean for the non-exponentiated estimate = - 0.34.|This outcome was recoded as a dichotomous outcome with a binary distribution and log link. The focal test is the difference in change from Baseline to Week 4 (i.e., Time) in the VLNC vs. NNC condition (i.e., Group), which is a cross-level interactive effect of Time and Group.||4.75|.11|.721
70912274|NCT03860077|141314789|SUPERIORITY|Frequencies of non-combustible alternative product use (ATP) were bimodal with peaks at 0 (no use) and 7 (daily use). Therefore, this outcome was recoded as a dichotomous outcome with a binary distribution and log link. The focal test is the difference in change from Baseline to Week 4 (i.e., Time) in the VLNC vs. NNC condition (i.e., Group), which is a cross-level interactive effect of Time and Group.|Odds Ratio (OR)|0.57|STANDARD_ERROR_OF_MEAN|0.96||0.564|TWO_SIDED|95.0|0.08|3.99|||Mixed Models Analysis||The reported value is the standard error of the mean for the non-exponentiated estimate = - 0.56.|||3.99|.08|.564
70912275|NCT03860077|141314790|SUPERIORITY||Slope|0.25|STANDARD_ERROR_OF_MEAN|1.56||0.876|TWO_SIDED|95.0|-2.92|3.42|||Mixed Models Analysis|||The study cigarette outcome is modeled with a normal, Gaussian distribution. The focal test is the difference in change from Baseline to Week 4 (i.e., Time) in the VLNC vs. NNC condition (i.e., Group), which is a cross-level interactive effect of Time and Group. Baseline in this analysis is average number of usual brand cigarettes at baseline, prior to randomization.||3.42|-2.92|.876
70912276|NCT03860077|141314791|SUPERIORITY|The focal test is the difference in change from Baseline to Week 4 (i.e., Time) in the VLNC vs. NNC condition (i.e., Group), which is a cross-level interactive effect of Time and Group.|Slope|-2166.79|STANDARD_ERROR_OF_MEAN|1753.48||0.226|TWO_SIDED|95.0|-5743.04|1409.47|||Mixed Models Analysis|||||1409.47|-5743.04|.226
70912277|NCT00430677|141314800|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.1||||0.746|TWO_SIDED|95.0|0.6|2.03||The median time to confirmed CRR was not estimable due to the low number of events. However, the time to confirmed CRR was compared between the abatacept and placebo treatment regimens using a score test.|Regression, Cox||Point estimate, 95% CI and P-value (based on Score Test) for the hazard ratio is determined by a Cox proportional hazards model including treatment as a covariate and stratified by prior treatment status.|||2.03|0.60|0.746
70912278|NCT00430677|141314800|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.6||||0.118|TWO_SIDED|95.0|0.89|2.83||The median time to confirmed CRR was not estimable due to the low number of events. However, the time to confirmed CRR was compared between the abatacept and placebo treatment regimens using a score test.|Regression, Cox||Point estimate, 95% CI and P-value (based on Score Test) for the hazard ratio is determined by a Cox proportional hazards model including treatment as a covariate and stratified by prior treatment status.|||2.83|0.89|0.118
70912279|NCT00430677|141314803|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.3|||||TWO_SIDED|95.0|0.91|1.78|||||Point Estimate, 95% CI for the hazard ratio was determined by a Cox proportional hazards model including treatment as a covariate and stratified by prior treatment status.|||1.78|0.91|
70912280|NCT00430677|141314803|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.3|||||TWO_SIDED|95.0|0.91|1.77|||||Point Estimate, 95% CI for the hazard ratio was determined by a Cox proportional hazards model including treatment as a covariate and stratified by prior treatment status.|||1.77|0.91|
70912281|NCT00430677|141314809|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21|||||TWO_SIDED|95.0|0.68|21.3||||||||21.3|0.68|
70912282|NCT00430677|141314809|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.49|1.59||||||||1.59|0.49|
70912283|NCT00430677|141314811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-0.13|0.19|||ANCOVA||Adjustment based on ANCOVA model with treatment as factor and randomization strata (prior treatment status) and baseline measurements as covariates.|||0.19|-0.13|
70912284|NCT00430677|141314811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.18|0.14|||ANCOVA||Adjustment based on ANCOVA model with treatment as factor and randomization strata (prior treatment status) and baseline measurements as covariates.|||0.14|-0.18|
70912285|NCT00836810|141314851|SUPERIORITY||||||<|0.001||||||A priory test for statistical significance was P\<0.05|t-test, 2 sided|||||||<0.001
70912286|NCT00836810|141314851|SUPERIORITY||||||<|0.001||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||<0.001
70912287|NCT00836810|141314851|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||||||A priori statistical significance set as P\<0.05|t-test, 2 sided|||||||<0.01
70912288|NCT00836810|141314852|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|A priori statistical significance set at P\<0.05||||||<0.001
70912289|NCT00836810|141314852|SUPERIORITY||||||<|0.01||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||<0.01
70912290|NCT00836810|141314852|SUPERIORITY||||||<|0.01||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||<0.01
70912291|NCT00836810|141314853|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.023
70912292|NCT00836810|141314853|SUPERIORITY|||||||0.0906||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.0906
70912293|NCT00836810|141314853|SUPERIORITY|||||||0.044||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.044
70912294|NCT00836810|141314854|SUPERIORITY|||||||0.007||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.007
70912295|NCT00836810|141314854|SUPERIORITY|||||||0.002||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.002
70912296|NCT00836810|141314854|SUPERIORITY|||||||0.57||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.57
70912297|NCT00836810|141314855|SUPERIORITY|||||||0.022||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.022
70912298|NCT00836810|141314855|SUPERIORITY|||||||0.002||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.002
70912299|NCT00836810|141314855|SUPERIORITY|||||||0.51||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.51
70912300|NCT00836810|141314856|SUPERIORITY|||||||0.003||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||.003
70912301|NCT00836810|141314856|SUPERIORITY|||||||0.001||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||.001
70912302|NCT00836810|141314856|SUPERIORITY|||||||0.88||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.88
71153671|NCT00488683|141800054|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.06||||0.69||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup A||||0.69
70912303|NCT00389519|141314925|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||two-sided test|ANCOVA|test from contrast statement from full model||"Planned interim efficacy analysis: 80 placebo and 80 high-dose ramipril subjects provided 93% power, alpha=0.032, to detect 5 mmHg difference in primary outcome. SD of 8.5 mmHg assumed. Alpha of 0.032 required for the planned interim efficacy analysis.~If study continued: 450 total subjects would provide 90% power, alpha=0.027, to detect 3 mmHg difference between placebo and combined ramipril dose groups. Alpha of 0.027 required for the final analysis."||||0.044
70912304|NCT00389519|141314926|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||two-sided, unadjusted|ANCOVA|test from contrast statement from full model||||||0.006
70912305|NCT04159506|141315051|SUPERIORITY||Median Difference (Final Values)|0.63|||<|0.05|TWO_SIDED|||||This pilot study was designed mostly to determine feasibility and acceptability of TEE, AC, and study methods. Nonetheless, Paired Difference Signed Rank Tests were used to compare conditions given small sample and non-normal distribution of data.|Wilcoxon (Mann-Whitney)|No adjustments were made given this was a pilot study focused on feasibility and acceptability.||||||<0.05
70912306|NCT04159506|141315052|SUPERIORITY||Median Difference (Final Values)|0.31|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|No adjustments were made given this was a pilot study focused on feasibility and acceptability.||This pilot study was designed mostly to determine feasibility and acceptability of TEE, AC, and study methods. Nonetheless, Paired Difference Signed Rank Tests were used to compare conditions given small sample and non-normal distribution of data.||||<0.05
70912307|NCT04159506|141315053|SUPERIORITY||Median Difference (Final Values)|0.67|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|No adjustments were made given this was a pilot study focused on feasibility and acceptability.||This pilot study was designed mostly to determine feasibility and acceptability of TEE, AC, and study methods. Nonetheless, Paired Difference Signed Rank Tests were used to compare conditions given small sample and non-normal distribution of data.||||<0.05
70912308|NCT02449044|141315059|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Day 1.|Student's t-test|||||||<0.0001
70912309|NCT02449044|141315059|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Day 14.|Student's t-test|||||||<0.0001
70912310|NCT02449044|141315059|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Day 31.|Student's t-test|||||||<0.0001
70912311|NCT02449044|141315059|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 10.|Student's t-test|||||||<0.0001
70912312|NCT02449044|141315059|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 18.|Student's t-test|||||||<0.0001
70912313|NCT02449044|141315059|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 26.|Student's t-test|||||||<0.0001
70912314|NCT02449044|141315059|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 34.|Student's t-test|||||||<0.0001
70912315|NCT02449044|141315059|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 42.|Student's t-test|||||||<0.0001
70912316|NCT02449044|141315059|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 50.|Student's t-test|||||||<0.0001
70912317|NCT02449044|141315059|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 58.|Student's t-test|||||||<0.0001
70912318|NCT02449044|141315059|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 70.|Student's t-test|||||||<0.0001
70912319|NCT02449044|141315059|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 82.|Student's t-test|||||||<0.0001
70912320|NCT02449044|141315059|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 94.|Student's t-test|||||||<0.0001
70912321|NCT02449044|141315059|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 106.|Student's t-test|||||||<0.0001
70912322|NCT02449044|141315059|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 118.|Student's t-test|||||||<0.0001
70912323|NCT02449044|141315059|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 130.|Student's t-test|||||||<0.0001
70912324|NCT02449044|141315059|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 142.|Student's t-test|||||||<0.0001
70912325|NCT02449044|141315059|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 154.|Student's t-test|||||||<0.0001
70912326|NCT02449044|141315059|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 166.|Student's t-test|||||||<0.0001
70912327|NCT02449044|141315059|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 178.|Student's t-test|||||||<0.0001
70912328|NCT02449044|141315059|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 190.|Student's t-test|||||||<0.0001
70912329|NCT02449044|141315059|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 202.|Student's t-test|||||||<0.0001
70912330|NCT02449044|141315059|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 214.|Student's t-test|||||||<0.0001
70912331|NCT02449044|141315066|SUPERIORITY_OR_OTHER|||||||0.4922|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Day 31||||0.4922
70912332|NCT02449044|141315066|SUPERIORITY_OR_OTHER|||||||0.1054|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 10||||0.1054
70912333|NCT02449044|141315066|SUPERIORITY_OR_OTHER|||||||0.7656|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 18||||0.7656
70912334|NCT02449044|141315066|SUPERIORITY_OR_OTHER|||||||0.7084|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 26||||0.7084
70912335|NCT02449044|141315066|SUPERIORITY_OR_OTHER|||||||0.5138|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 34||||0.5138
71092681|NCT03034967|141691786|OTHER||Median Posterior Hazard Ratio|2.0|||||TWO_SIDED|90.0|0.9|4.5|||||Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|4.5|0.9|
71092682|NCT03034967|141691789|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.5|||||TWO_SIDED|90.0|1.0|2.2|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator %predicted FEV1 at Screening.|2.2|1.0|
71092683|NCT03034967|141691789|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.1|||||TWO_SIDED|90.0|0.8|1.7|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|1.7|0.8|
71092684|NCT03034967|141691789|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.1|||||TWO_SIDED|90.0|0.7|1.6|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|1.6|0.7|
71092685|NCT03034967|141691789|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.4|||||TWO_SIDED|90.0|1.0|2.1|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|2.1|1.0|
71092686|NCT03034967|141691789|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.6|||||TWO_SIDED|90.0|1.1|2.3|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|2.3|1.1|
71092687|NCT03034967|141691790|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.8|||||TWO_SIDED|90.0|0.7|5.5|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|5.5|0.7|
71092688|NCT03034967|141691790|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.9|||||TWO_SIDED|90.0|0.7|5.8|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|5.8|0.7|
71092689|NCT03034967|141691790|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.8|||||TWO_SIDED|90.0|0.7|5.6|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|5.6|0.7|
71092690|NCT03034967|141691790|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|2.3|||||TWO_SIDED|90.0|0.9|6.9|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|6.9|0.9|
71092691|NCT03034967|141691790|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|0.8|||||TWO_SIDED|90.0|0.2|2.7|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|2.7|0.2|
71092692|NCT03034967|141691793|OTHER||Odds Ratio (OR)|1.51||||0.208|TWO_SIDED|90.0|0.88|2.59||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.|||2.59|0.88|0.208
71092693|NCT03034967|141691793|OTHER||Odds Ratio (OR)|1.27||||0.482|TWO_SIDED|90.0|0.73|2.2||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|||2.20|0.73|0.482
71092694|NCT03034967|141691793|OTHER||Odds Ratio (OR)|1.47||||0.239|TWO_SIDED|90.0|0.86|2.53||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|||2.53|0.86|0.239
71092695|NCT03034967|141691793|OTHER||Odds Ratio (OR)|1.31||||0.426|TWO_SIDED|90.0|0.75|2.26||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|||2.26|0.75|0.426
71092696|NCT03034967|141691793|OTHER||Odds Ratio (OR)|0.9||||0.763|TWO_SIDED|90.0|0.52|1.58||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|||1.58|0.52|0.763
71092697|NCT03034967|141691795|OTHER||Odds Ratio (OR)|1.01||||0.973|TWO_SIDED|90.0|0.58|1.76||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.|||1.76|0.58|0.973
70912336|NCT02449044|141315066|SUPERIORITY_OR_OTHER|||||||0.7175|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 42||||0.7175
70912337|NCT02449044|141315066|SUPERIORITY_OR_OTHER|||||||0.354|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 50||||0.3540
70912338|NCT02449044|141315066|SUPERIORITY_OR_OTHER|||||||0.0852|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 58||||0.0852
70912339|NCT02449044|141315066|SUPERIORITY_OR_OTHER|||||||0.1923|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 70||||0.1923
70912340|NCT02449044|141315066|SUPERIORITY_OR_OTHER|||||||0.2335|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 82||||0.2335
70912341|NCT02449044|141315066|SUPERIORITY_OR_OTHER|||||||0.1346|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 94||||0.1346
70912342|NCT02449044|141315066|SUPERIORITY_OR_OTHER|||||||0.5237|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 106||||0.5237
70912343|NCT02449044|141315066|SUPERIORITY_OR_OTHER|||||||0.3476|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 118||||0.3476
71092698|NCT03034967|141691795|OTHER||Odds Ratio (OR)|0.93||||0.825|TWO_SIDED|90.0|0.53|1.63||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|||1.63|0.53|0.825
71092699|NCT03034967|141691795|OTHER||Odds Ratio (OR)|0.95||||0.887|TWO_SIDED|90.0|0.55|1.66||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|||1.66|0.55|0.887
70912344|NCT02449044|141315066|SUPERIORITY_OR_OTHER|||||||0.2488|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 130||||0.2488
70912345|NCT02449044|141315066|SUPERIORITY_OR_OTHER|||||||0.1598|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 142||||0.1598
70912346|NCT02449044|141315066|SUPERIORITY_OR_OTHER|||||||0.282|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 154||||0.2820
70912347|NCT02449044|141315066|SUPERIORITY_OR_OTHER|||||||0.3743|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 166||||0.3743
70912348|NCT02449044|141315066|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 178||||0.3600
70912349|NCT02449044|141315066|SUPERIORITY_OR_OTHER|||||||0.3101|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 190||||0.3101
70912350|NCT02449044|141315066|SUPERIORITY_OR_OTHER|||||||0.0269|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 202||||0.0269
70912351|NCT02449044|141315066|SUPERIORITY_OR_OTHER|||||||0.0944|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 214||||0.0944
70912352|NCT02449044|141315067|SUPERIORITY_OR_OTHER|||||||0.1739|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student t-test|||Statistical analysis at Day 14||||0.1739
70912353|NCT02449044|141315067|SUPERIORITY_OR_OTHER|||||||0.6095|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Day 31||||0.6095
70912354|NCT02449044|141315067|SUPERIORITY_OR_OTHER|||||||0.6902|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 10||||0.6902
70912355|NCT02449044|141315067|SUPERIORITY_OR_OTHER|||||||0.634|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 18||||0.6340
70912356|NCT02449044|141315067|SUPERIORITY_OR_OTHER|||||||0.321|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 26||||0.3210
70912357|NCT02449044|141315067|SUPERIORITY_OR_OTHER|||||||0.7787|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 34||||0.7787
70912358|NCT02449044|141315067|SUPERIORITY_OR_OTHER|||||||0.2198|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 42||||0.2198
70912359|NCT02449044|141315067|SUPERIORITY_OR_OTHER|||||||0.1926|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 50||||0.1926
70912360|NCT02449044|141315067|SUPERIORITY_OR_OTHER|||||||0.3109|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 58||||0.3109
70912361|NCT02449044|141315067|SUPERIORITY_OR_OTHER|||||||0.2269|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 70||||0.2269
70912362|NCT02449044|141315067|SUPERIORITY_OR_OTHER|||||||0.2749|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 82||||0.2749
71092700|NCT03034967|141691795|OTHER||Odds Ratio (OR)|1.21||||0.567|TWO_SIDED|90.0|0.69|2.13||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|||2.13|0.69|0.567
70912363|NCT02449044|141315067|SUPERIORITY_OR_OTHER|||||||0.0702|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 94||||0.0702
70912364|NCT02449044|141315067|SUPERIORITY_OR_OTHER|||||||0.0412|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 106||||0.0412
71092701|NCT03034967|141691795|OTHER||Odds Ratio (OR)|1.26||||0.501|TWO_SIDED|90.0|0.72|2.2||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|||2.20|0.72|0.501
71092702|NCT04279483|141691806|SUPERIORITY|Linear mixed effects|Slope|-0.64|STANDARD_ERROR_OF_MEAN|1.95||0.74|TWO_SIDED|||||Statistical significance was evaluated at α = 0.05.|Mixed Models Analysis|||Our hypothesis was that craving would be higher for those in the Tobacco retailer group, relative to the Nontobacco retailer group, during the intervention phase but not the baseline phase. We tested the interaction between study phase and experimental condition, in a model where the baseline was the reference study phase and Tobacco group was the reference experimental condition.||||0.74
71092703|NCT04279483|141691806|SUPERIORITY|Linear mixed effects|Slope|-0.84|STANDARD_ERROR_OF_MEAN|2.12||0.69|TWO_SIDED|||||Statistical significance was evaluated at α = 0.05.|Mixed Models Analysis|||Our hypothesis was that craving would be higher for those in the Tobacco retailer group, relative to the control group, during the intervention phase but not the baseline phase. We tested the interaction between study phase and experimental condition, in a model where the baseline was the reference study phase and Tobacco group was the reference experimental condition.||||0.69
71092704|NCT04279483|141691807|SUPERIORITY|Linear mixed effects|Slope|-0.37|STANDARD_ERROR_OF_MEAN|0.54||0.49|TWO_SIDED|||||Statistical significance was evaluated at α = 0.05.|Mixed Models Analysis|||Our hypothesis was that cigarettes smoked would be higher for those in the Tobacco retailer group, relative to the Nontobacco retailer group, during the intervention phase but not the baseline phase. We tested the interaction between study phase and experimental condition, in a model where the baseline was the reference study phase and Tobacco group was the reference experimental condition.||||0.49
71092705|NCT04279483|141691807|SUPERIORITY|Linear mixed effects|Slope|0.21|STANDARD_ERROR_OF_MEAN|0.59||0.72|TWO_SIDED|||||Statistical significance was evaluated at α = 0.05.|Mixed Models Analysis|||Our hypothesis was that craving would be higher for those in the Tobacco retailer group, relative to the control group, during the intervention phase but not the baseline phase. We tested the interaction between study phase and experimental condition, in a model where the baseline was the reference study phase and Tobacco group was the reference experimental condition.||||0.72
71092706|NCT00879658|141691854|SUPERIORITY||Negative binomial regression model|0.524||||0.148|TWO_SIDED|95.0|0.219|1.257||Pairwise comparison and p-values refer to ARR on active treatment compared to placebo. An ARR-ratio \<1 favors active treatment.|Mixed Models Analysis|Treatment compared to placebo based on negative binomial regression model, adjusted for treatment group and baseline number of relapses in prev 2 yrs.|||An ARR-ratio \<1 favors active treatment.|1.257|0.219|0.148
71092707|NCT00879658|141691854|SUPERIORITY||Negative binomial regression model|0.34||||0.041|TWO_SIDED|95.0|0.121|0.956||Pairwise comparison and p-values refer to ARR on active treatment compared to placebo. An ARR-ratio \<1 favors active treatment.|Mixed Models Analysis|Treatment compared to placebo based on negative binomial regression model, adjusted for treatment group and baseline number of relapses in prev 2 yrs.||||0.956|0.121|0.041
71092708|NCT00879658|141691854|SUPERIORITY||Negative binomial regression model|1.051||||0.899|TWO_SIDED|95.0|0.486|2.273||Pairwise comparison and p-values refer to ARR on active treatment compared to placebo. An ARR-ratio \<1 favors active treatment.|Mixed Models Analysis|Treatment compared to placebo based on negative binomial regression model, adjusted for treatment group and baseline number of relapses in prev 2 yrs.||||2.273|0.486|0.899
71092709|NCT00879658|141691855|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|0.915||||0.879|TWO_SIDED|95.0|0.288|2.925|||Regression, Logistic|"Proportions are estimated from the logistic regression model.~\- An odds ratio of \> 1 indicates an increased odds in favor of the active treatment."||||2.925|0.288|0.879
71092710|NCT00879658|141691855|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|1.745||||0.399|TWO_SIDED|95.0|0.484|7.167||"Proportions are estimated from the logistic regression model.~\- An odds ratio of \> 1 indicates an increased odds in favor of the active treatment."|Regression, Logistic|||||7.167|0.484|0.399
71092711|NCT00879658|141691855|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|1.697||||0.454|TWO_SIDED|95.0|0.438|8.296||"Proportions are estimated from the logistic regression model.~\- An odds ratio of \> 1 indicates an increased odds in favor of the active treatment."|Regression, Logistic|||||8.296|0.438|0.454
70912365|NCT02449044|141315067|SUPERIORITY_OR_OTHER|||||||0.4448|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 142||||0.4448
70912366|NCT02449044|141315067|SUPERIORITY_OR_OTHER|||||||0.6233|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 166||||0.6233
70912367|NCT02449044|141315067|SUPERIORITY_OR_OTHER|||||||0.1001|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 178||||0.1001
70912368|NCT02449044|141315067|SUPERIORITY_OR_OTHER|||||||0.3739|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 190||||0.3739
70912369|NCT02449044|141315067|SUPERIORITY_OR_OTHER|||||||0.3334|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 214||||0.3334
70912370|NCT02449044|141315068|SUPERIORITY_OR_OTHER|||||||0.2575|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student t-test|||Statistical analysis at Day 14||||0.2575
71092712|NCT00879658|141691855|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|0.509||||0.223|TWO_SIDED|95.0|0.166|1.511||"Proportions are estimated from the logistic regression model.~\- An odds ratio of \> 1 indicates an increased odds in favor of the active treatment."|Regression, Logistic|||||1.511|0.166|0.223
71092713|NCT00879658|141691855|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|0.785||||0.668|TWO_SIDED|95.0|0.253|2.392||"Proportions are estimated from the logistic regression model.~\- An odds ratio of \> 1 indicates an increased odds in favor of the active treatment."|Regression, Logistic|||||2.392|0.253|0.668
70912371|NCT02449044|141315068|SUPERIORITY_OR_OTHER|||||||0.2715|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Day 31||||0.2715
70912372|NCT02449044|141315068|SUPERIORITY_OR_OTHER|||||||0.686|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 10||||0.6860
70912373|NCT02449044|141315068|SUPERIORITY_OR_OTHER|||||||0.0224|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 18||||0.0224
70912374|NCT02449044|141315068|SUPERIORITY_OR_OTHER|||||||0.1871|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 26||||0.1871
70912375|NCT02449044|141315068|SUPERIORITY_OR_OTHER|||||||0.0039|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 34||||0.0039
70912376|NCT02449044|141315068|SUPERIORITY_OR_OTHER|||||||0.0325|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 42||||0.0325
70912377|NCT02449044|141315068|SUPERIORITY_OR_OTHER|||||||0.0631|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 50||||0.0631
70912378|NCT02449044|141315068|SUPERIORITY_OR_OTHER|||||||0.0277|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 58||||0.0277
70912379|NCT02449044|141315068|SUPERIORITY_OR_OTHER|||||||0.0128|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 70||||0.0128
70912380|NCT02449044|141315068|SUPERIORITY_OR_OTHER|||||||0.0164|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 82||||0.0164
70912381|NCT02449044|141315068|SUPERIORITY_OR_OTHER|||||||0.0119|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 94||||0.0119
70912382|NCT02449044|141315068|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 106||||0.0013
70912383|NCT02449044|141315068|SUPERIORITY_OR_OTHER|||||||0.6691|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 142||||0.6691
70912384|NCT02449044|141315068|SUPERIORITY_OR_OTHER|||||||0.6923|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 166||||0.6923
70912385|NCT02449044|141315068|SUPERIORITY_OR_OTHER|||||||0.9292|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 178||||0.9292
70912386|NCT02449044|141315068|SUPERIORITY_OR_OTHER|||||||0.4401|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 190||||0.4401
70912387|NCT02449044|141315068|SUPERIORITY_OR_OTHER|||||||0.3609|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 214||||0.3609
70912388|NCT02624778|141315070|SUPERIORITY||LS Mean|-0.071|STANDARD_ERROR_OF_MEAN|0.07||0.309|TWO_SIDED|95.0|-0.21|0.07|||Mixed Models Analysis|||||0.07|-0.21|0.309
70912389|NCT02624778|141315070|SUPERIORITY||LS Mean|-0.133|STANDARD_ERROR_OF_MEAN|0.07||0.061|TWO_SIDED|95.0|-0.27|0.01|||Mixed Models Analysis|||||0.01|-0.27|0.061
70912390|NCT02624778|141315070|SUPERIORITY||LS Mean|-0.205|STANDARD_ERROR_OF_MEAN|0.1||0.053|TWO_SIDED|95.0|-0.41|0.0|||Mixed Models Analysis|||||0.00|-0.41|0.053
70912391|NCT02624778|141315070|SUPERIORITY||LS Mean|-0.255|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.38|-0.13|||Mixed Models Analysis|||||-0.13|-0.38|<0.001
70912392|NCT02624778|141315070|SUPERIORITY||LS Mean|-0.369|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.51|-0.23|||Mixed Models Analysis|||||-0.23|-0.51|<0.001
70912393|NCT02624778|141315070|SUPERIORITY||LS Mean|-0.329|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.46|-0.2|||Mixed Models Analysis|||||-0.20|-0.46|<0.001
70912394|NCT01149681|141315145|SUPERIORITY|||||||0.2364|||||||Repeated measures analysis|||||||0.2364
70912395|NCT03710564|141315147|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.76||0.4537|TWO_SIDED|95.0|-2.1|0.9|||Pairwise ANOVA|||||0.9|-2.1|0.4537
70912396|NCT00930813|141315174|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||t-test, 2 sided|||The study required 100 subjects to provide 80% power to detect a clinically meaningful difference in late lumen loss of 15% of reference vessel diameter between treatment groups on the basis of a 2-sample Student t test with 2-sided alpha 0.05.||||0.016
70912397|NCT00315120|141315185|SUPERIORITY_OR_OTHER||Response ratio|2.0||||0.007|TWO_SIDED|95.0|1.2|3.2|||Chi-squared|||||3.2|1.2|0.007
71092714|NCT00879658|141691856|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|1.996||||0.178|TWO_SIDED|95.0|0.731|5.669|||Regression, Logistic|Proportions are estimated from the logistic regression model. - An odds ratio of \> 1 indicates an increased odds in favor of the active treatment.||||5.669|0.731|0.178
71092715|NCT00879658|141691856|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|4.12||||0.014|TWO_SIDED|95.0|1.328|14.681||Proportions are estimated from the logistic regression model. - An odds ratio of \> 1 indicates an increased odds in favor of the active treatment.|Regression, Logistic|||||14.681|1.328|0.014
71092716|NCT00879658|141691856|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|1.266||||0.642|TWO_SIDED|95.0|0.468|3.494||Proportions are estimated from the logistic regression model. - An odds ratio of \> 1 indicates an increased odds in favor of the active treatment.|Regression, Logistic|||||3.494|0.468|0.642
71092717|NCT00879658|141691857|SUPERIORITY||lesion ratio|0.138|||<|0.001|TWO_SIDED|95.0|0.047|0.408|||Regression, Logistic|new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model||Pairwise treatment comparison between different BAF312 dose groups and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.408|0.047|<0.001
71092718|NCT00879658|141691857|SUPERIORITY||lesion ratio|0.307||||0.012|TWO_SIDED|95.0|0.123|0.771||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.771|0.123|0.012
71092719|NCT00879658|141691857|SUPERIORITY||lesion ratio|0.113|||<|0.001|TWO_SIDED|95.0|0.036|0.358||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.358|0.036|<0.001
71092720|NCT00879658|141691857|SUPERIORITY||lesion ratio|0.375||||0.021|TWO_SIDED|95.0|0.163|0.86||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.860|0.163|0.021
71092721|NCT00879658|141691857|SUPERIORITY||lesion ratio|0.478||||0.062|TWO_SIDED|95.0|0.22|1.037||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||1.037|0.220|0.062
71092722|NCT00879658|141691858|SUPERIORITY|Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|Lesion ratio|0.154|||<|0.001|TWO_SIDED|95.0|0.063|0.376|||Regression, Logistic|new lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model||||0.376|0.063|<0.001
71092723|NCT00879658|141691858|SUPERIORITY||lesion ratio|0.228||||0.005|TWO_SIDED|95.0|0.081|0.641||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.641|0.081|0.005
71092724|NCT00879658|141691858|SUPERIORITY||lesion ratio|0.188|||<|0.001|TWO_SIDED|95.0|0.07|0.509||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.509|0.070|<0.001
71092725|NCT00879658|141691859|SUPERIORITY|Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|lesion ratio|0.279||||0.002|TWO_SIDED|95.0|0.124|0.628||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||||0.628|0.124|0.002
71153672|NCT00488683|141800054|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.14||||0.3||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup C||||0.30
71153673|NCT00488683|141800054|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.81|||<|0.0001||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup W-135||||<0.0001
71153674|NCT00488683|141800054|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.67||||0.001||95.0||||Values from Groups I, II and III were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup Y||||0.001
71153675|NCT00488683|141800054|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.08||||0.61||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup A||||0.61
70850343|NCT02657408|141188422|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|0.64|||||TWO_SIDED|90.0|0.43|0.97||||||The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||0.97|0.43|
70912398|NCT00315120|141315190|SUPERIORITY_OR_OTHER||Response ratio|1.1||||0.72|TWO_SIDED|95.0|0.7|1.7|||Chi-squared|||||1.7|0.7|0.72
71092726|NCT00879658|141691859|SUPERIORITY||lesion ratio|0.396||||0.019|TWO_SIDED|95.0|0.182|0.861||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.861|0.182|0.019
70912399|NCT02002819|141315211|SUPERIORITY||Mean Difference (Net)|0.07||||0.55|TWO_SIDED|95.0|-0.18|0.32|||ANOVA|||||0.32|-0.18|0.55
70912400|NCT02002819|141315212|SUPERIORITY||Mean Difference (Net)|2.9||||0.14|TWO_SIDED|95.0|-1.0|6.8|||ANOVA|||||6.8|-1.0|0.14
70912401|NCT02002819|141315213|SUPERIORITY||Mean Difference (Net)|-1.0||||0.43|TWO_SIDED|95.0|-3.4|1.5|||ANOVA|||||1.5|-3.4|.43
70912402|NCT02002819|141315214|SUPERIORITY||Mean Difference (Net)|0.1||||0.63|TWO_SIDED|95.0|-0.2|0.4|||ANOVA|||||0.4|-0.2|0.63
70912403|NCT02002819|141315215|SUPERIORITY||Mean Difference (Net)|0.1||||0.9|TWO_SIDED|95.0|-1.1|1.3|||ANOVA|||||1.3|-1.1|0.90
70912404|NCT02002819|141315216|SUPERIORITY||Mean Difference (Net)|0.0||||0.8|TWO_SIDED|95.0|-0.3|0.3|||ANOVA|||||0.3|-0.3|0.80
70912405|NCT02002819|141315217|SUPERIORITY||Mean Difference (Net)|-1.0||||0.46|TWO_SIDED|95.0|-3.6|1.7|||ANOVA|||||1.7|-3.6|0.46
70912406|NCT02002819|141315218|SUPERIORITY||Mean Difference (Net)|0.1||||0.4|TWO_SIDED|95.0|-0.9|1.1|||ANOVA|||||1.1|-0.9|0.40
70912407|NCT02002819|141315219|SUPERIORITY||Mean Difference (Net)|7.4||||0.046|TWO_SIDED|95.0|0.2|14.7|||ANOVA|||||14.7|0.2|0.046
70912408|NCT02002819|141315220|SUPERIORITY||Mean Difference (Net)|-2.5||||0.3|TWO_SIDED|95.0|-7.8|2.7|||ANOVA|||||2.7|-7.8|.30
70912409|NCT02002819|141315221|SUPERIORITY||Mean Difference (Net)|3.8||||0.52|TWO_SIDED|95.0|-8.5|16.0|||Cohen f|||||16.0|-8.5|0.52
70912410|NCT02002819|141315222|SUPERIORITY||Mean Difference (Net)|0.7||||0.4|TWO_SIDED|95.0|-1.0|2.4|||ANOVA|||||2.4|-1.0|0.40
70912411|NCT02002819|141315223|SUPERIORITY||Mean Difference (Net)|-0.2||||0.63|TWO_SIDED|95.0|-1.1|0.7|||ANOVA|||||0.7|-1.1|0.63
71092727|NCT00879658|141691859|SUPERIORITY||lesion ratio|0.154|||<|0.001|TWO_SIDED|95.0|0.059|0.4||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.400|0.059|<0.001
70912412|NCT02002819|141315225|SUPERIORITY||Mean Difference (Net)|0.8||||0.15|TWO_SIDED|95.0|-0.3|1.8|||ANOVA|||||1.8|-0.3|.15
70912413|NCT03055767|141315252|SUPERIORITY|||||||0.038|||||||Wilcoxon signed-rank test|||||||0.038
70912414|NCT03055767|141315253|SUPERIORITY|||||||0.047|||||||Wilcoxon signed-rank test)|||||||0.047
70912415|NCT03055767|141315254|SUPERIORITY|||||||0.148|||||||Wilcoxon signed-rank test)|||||||0.148
70912416|NCT03055767|141315255|SUPERIORITY|||||||0.047|||||||Wilcoxon signed-rank test)|||||||0.047
70912417|NCT03055767|141315256|SUPERIORITY|||||||0.002|||||||Wilcoxon signed-rank test)|||||||0.002
70912418|NCT03055767|141315257|SUPERIORITY|||||||0.82|||||||McNemar|||||||0.82
70912419|NCT03055767|141315258|SUPERIORITY|||||||0.006|||||||McNemar|||||||0.006
70912420|NCT03055767|141315259|SUPERIORITY|||||||0.039|||||||McNemar|||||||0.039
70912421|NCT03055767|141315260|SUPERIORITY|||||||0.016|||||||McNemar|||||||0.016
70912422|NCT03055767|141315261|SUPERIORITY|||||||0.18|||||||McNemar|||||||0.18
70912423|NCT03055767|141315262|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed-rank test)|||||||<0.001
70912424|NCT03055767|141315263|SUPERIORITY|||||||0.64|||||||Wilcoxon signed-rank test)|||||||0.64
70912425|NCT02661997|141315268|SUPERIORITY|||||||0.58||||||Between group differences|ANOVA|||||||0.58
70912426|NCT02661997|141315269|SUPERIORITY|||||||0.88|||||||ANOVA|||||||0.88
70912427|NCT02661997|141315270|SUPERIORITY|||||||0.17|||||||ANOVA|||||||0.17
70912428|NCT02661997|141315271|SUPERIORITY|||||||0.88|||||||ANOVA|||This is an analysis of pre to post-treatment changes on the Physical Health subscale of the PROMIS Global Health Scale||||0.88
70912429|NCT02661997|141315272|SUPERIORITY|||||||0.032||||||P-value for group by time interaction|ANOVA|||||||0.032
70912430|NCT02661997|141315273|SUPERIORITY|||||||0.006||||||P-value for group by time interaction|ANOVA|||||||0.006
70912431|NCT02661997|141315274|SUPERIORITY|||||||0.44||||||P-value for group by time interaction|ANOVA|||||||0.44
70912432|NCT02661997|141315275|SUPERIORITY|||||||0.36||||||P-value for group by time interaction|ANOVA|||||||0.36
70912433|NCT02661997|141315276|SUPERIORITY|||||||0.24|||||||ANOVA|||||||0.24
70912434|NCT02661997|141315277|SUPERIORITY|||||||0.55||||||P-value for group by time interaction|ANOVA|||||||0.55
70912435|NCT02661997|141315278|SUPERIORITY|||||||0.36||||||P-value for group by time interaction|ANOVA|||||||0.36
70912436|NCT02661997|141315279|SUPERIORITY|||||||0.73||||||P-value for group by time interaction|ANOVA|||||||0.73
70912437|NCT00742274|141315302|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
70912438|NCT02427737|141315304|SUPERIORITY||||||<|0.0001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Comparison among trained and untrained sites||||<0.0001
70912439|NCT02427737|141315304|SUPERIORITY|||||||0.3037||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Change in the average quarterly completion rate as compared to the baseline quarter||||0.3037
70912440|NCT02427737|141315304|SUPERIORITY||||||<|0.01||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Change in the average quarterly completion rate as compared to the baseline quarter||||<0.01
70912441|NCT02427737|141315305|SUPERIORITY||||||<|0.0001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Comparison among trained and untrained sites||||<0.0001
70912442|NCT02427737|141315305|SUPERIORITY|||||||0.201||||||Bonferroni-correction was not done since the corrected p-value would be have been greater than 1.|Chi-squared|||Change in the average quarterly completion rate as compared to the baseline quarter||||0.2010
70912443|NCT02427737|141315305|SUPERIORITY||||||<|0.001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared|||Change in the average quarterly completion rate as compared to the baseline quarter||||<0.001
70912444|NCT02427737|141315306|SUPERIORITY||||||<|0.0001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared|||Comparison among trained and untrained sites||||<0.0001
70912445|NCT02427737|141315306|SUPERIORITY|||||||0.303||||||"Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.~Chi-square analysis was used to assess equipment utilization at trained sites compared with untrained sites when stratifying by time (chi-square MH = 858.2)."|Chi-squared|||Change in the quarterly equipment utilization rate as compared to the baseline quarter Q4FY15 over time and at sites||||0.303
70912446|NCT02427737|141315306|SUPERIORITY||||||<|0.001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Change in the average quarterly completion rate as compared to the baseline quarter||||<0.001
70912447|NCT02427737|141315307|SUPERIORITY||||||<|0.0001||||||CMH test was used with time as a strata variable (rather than pooling all data together as in the regular chi-squared test). The CMH chi-squared value was 858.2, and the regular chi-squared value was 858.8.|Chi-squared, Corrected|Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.||||||<0.0001
70912448|NCT02427737|141315308|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
70912449|NCT02427737|141315310|SUPERIORITY|||||||0.2357||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Comparison among trained and untrained sites||||0.2357
70912450|NCT02427737|141315310|SUPERIORITY|||||||0.8523||||||No Bonferroni-correction|Chi-squared|||Change in the quarterly no-shows as compared to the baseline quarter||||0.8523
70912451|NCT02427737|141315310|SUPERIORITY|||||||0.5883||||||Bonferroni-correction was not done for this nonsignificant result since the corrected p-value would be have been greater than 1, which is not possible.|Chi-squared|||Change in the quarterly average no-show rate as compared to the baseline quarter at untrained sites||||0.5883
70912452|NCT02427737|141315311|SUPERIORITY|||||||0.0195||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Comparison among trained and untrained sites||||0.0195
70912453|NCT02427737|141315311|SUPERIORITY|||||||0.276||||||No Bonferroni-correction|Chi-squared|||Change in the quarterly no-shows compared to the baseline quarter||||0.276
70912454|NCT02427737|141315311|SUPERIORITY|||||||0.2764||||||No Bonferroni-correction|Chi-squared|||Change in the quarterly no-shows as compared to the baseline quarter at untrained sites||||0.2764
70912455|NCT02427737|141315312|SUPERIORITY||||||<|0.01||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Comparison among trained and untrained sites||||<0.01
70912456|NCT02427737|141315312|SUPERIORITY|||||||0.9012||||||Bonferroni-correction was not done since the corrected p-value would be have been greater than 1.|Chi-squared|||Change in the quarterly average no show rate as compared to the baseline quarter for trained sites||||0.9012
70912457|NCT02427737|141315312|SUPERIORITY|||||||0.9065||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Change in the quarterly average no-show rate as compared to the baseline quarter for untrained sites||||0.9065
71092728|NCT00879658|141691859|SUPERIORITY||lesion ratio|0.454||||0.035|TWO_SIDED|95.0|0.219|0.945||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.945|0.219|0.035
70912458|NCT02427737|141315313|SUPERIORITY||||||<|0.0001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|CMH test with time as a strata variable was 28.7; chi-square value with pooling all data together was 28.6||Comparison among trained and untrained sites over time||||<0.0001
70912459|NCT02427737|141315318|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71092729|NCT00879658|141691859|SUPERIORITY||lesion ratio|0.555||||0.087|TWO_SIDED|96.0|0.283|1.09||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||1.090|0.283|0.087
70912460|NCT02427737|141315319|SUPERIORITY|||||||0.2396|||||||Chi-squared|||||||0.2396
70912461|NCT02427737|141315320|SUPERIORITY|||||||0.5267|||||||Chi-squared|||||||0.5267
70912462|NCT02427737|141315321|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
70912463|NCT02427737|141315322|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
70912464|NCT00478556|141315323|SUPERIORITY_OR_OTHER||difference in proportions|62.0|||<|0.001|||||||Binomial test of proportion|tested if values were different from 50%||All individuals tasted both preparations and indicated preference. A binomial test of proportion was done to see if these values differed from 50%.||||<0.001
70912465|NCT00478556|141315324|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum test was used to assess differences in bowel opacification score between the two groups.||||0.270
70912466|NCT02974010|141315325|SUPERIORITY|||||||0.03||||||BDM LS difference overall|Mixed Models Analysis|BDM LS difference overall||||||.03
70912467|NCT00320489|141315331|SUPERIORITY_OR_OTHER|||||||0.612||95.0|||||Log Rank|||||||0.612
70912468|NCT00320489|141315332|SUPERIORITY_OR_OTHER|||||||0.649||95.0||||P-Value is for change from baseline at Week 104.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit Baseline.||||||0.649
70912469|NCT00320489|141315333|SUPERIORITY_OR_OTHER|||||||0.744||95.0||||P-value for change at Week 104 in Mental Score Detail.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.744
70912470|NCT00320489|141315333|SUPERIORITY_OR_OTHER|||||||0.653||95.0||||P-value for change at Week 104 in Physical Score Detail.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.653
70912471|NCT00320489|141315333|SUPERIORITY_OR_OTHER|||||||0.64||95.0||||P-value for change at Week 104 in Physical Functioning.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.640
70912472|NCT00320489|141315333|SUPERIORITY_OR_OTHER|||||||0.454||95.0||||P-value for change at Week 104 in Role-Physical.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.454
70912473|NCT00320489|141315333|SUPERIORITY_OR_OTHER|||||||0.135||95.0||||P-value for change at Week 104 in Bodily Pain.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.135
70912474|NCT00320489|141315333|SUPERIORITY_OR_OTHER|||||||0.229||95.0||||P-value for change at Week 104 in General Health.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.229
70912475|NCT00320489|141315333|SUPERIORITY_OR_OTHER|||||||0.594||95.0||||P-value for change at Week 104 in Vitality.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.594
70912476|NCT00320489|141315333|SUPERIORITY_OR_OTHER|||||||0.256||95.0||||P-value for change at Week 104 in Social Functioning.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.256
70912477|NCT00320489|141315333|SUPERIORITY_OR_OTHER|||||||0.775||95.0||||P-value for change at Week 104 in Role-Emotional.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.775
70912478|NCT00320489|141315333|SUPERIORITY_OR_OTHER|||||||0.781||95.0||||P-value for change at Week 104 in Mental Health.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.781
70912479|NCT00320489|141315334|SUPERIORITY_OR_OTHER|||||||0.465||95.0||||P-value is for change from baseline to Week 104.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.465
70912480|NCT00320489|141315335|SUPERIORITY_OR_OTHER|||||||0.581||95.0||||P-value is for change from baseline to Week 104.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.581
70912481|NCT00320489|141315338|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|P-value is type III p-value of ANOVA model: Total number of hospitalization days = Therapy.||||||0.020
70912482|NCT00320489|141315339|SUPERIORITY_OR_OTHER|||||||0.583||95.0||||P-value is for Total Score (Items 1-5) change to Week 104.|ANCOVA|Model: change = investigator, treatment, and baseline.||||||0.583
70912483|NCT00320489|141315339|SUPERIORITY_OR_OTHER|||||||0.747||95.0||||P-value is for Total Score (Items 1-4) change to Week 104.|ANCOVA|Model: change = investigator, treatment, and baseline.||||||0.747
70912484|NCT00320489|141315340|SUPERIORITY_OR_OTHER|||||||0.371||95.0||||P-value is for change from baseline to Week 104.|ANCOVA|Model: change = investigator, treatment, and baseline.||||||0.371
70912485|NCT00320489|141315341|SUPERIORITY_OR_OTHER|||||||0.681||95.0||||P-value is fro change from baseline to Week 104.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.681
70912486|NCT00320489|141315342|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||P-value is for overall satisfaction with current medication.|ANCOVA|Model: Actual Result = Therapy, Investigator, Visit, Therapy\*Visit.||||||0.60
70912487|NCT00320489|141315342|SUPERIORITY_OR_OTHER|||||||0.258||95.0||||P-value is for preference current/previous medication.|ANCOVA|Model: Actual Result = Therapy, Investigator, Visit, Therapy\*Visit||||||.258
70912488|NCT00320489|141315342|SUPERIORITY_OR_OTHER|||||||0.492||95.0||||P-value is for side effects - current vs previous medication.|ANCOVA|Model: Actual Result = Therapy, Investigator, Visit, Therapy\*Visit.||||||0.492
70912489|NCT00320489|141315343|SUPERIORITY_OR_OTHER|||||||0.854||95.0|||||ANCOVA|Model: Actual Result = Therapy, Investigator, Visit, Therapy\*Visit.||||||0.854
70912490|NCT00320489|141315344|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Fisher Exact|||||||0.600
70912491|NCT00320489|141315345|SUPERIORITY_OR_OTHER|||||||0.282||95.0|||||ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit Baseline.||||||0.282
70912492|NCT00320489|141315346|SUPERIORITY_OR_OTHER|||||||0.834||95.0||||P-value is for PANSS Total Score.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit Baseline.||||||0.834
70912493|NCT00320489|141315346|SUPERIORITY_OR_OTHER|||||||0.871||95.0||||P-value is for PANSS Positive Score.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit Baseline.||||||0.871
70912494|NCT00320489|141315346|SUPERIORITY_OR_OTHER|||||||0.692||95.0||||P-value is for PANSS Negative Score.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.692
70912495|NCT00320489|141315346|SUPERIORITY_OR_OTHER|||||||0.893||95.0||||P-value is for PANSS General Psychopathology Score.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.893
70912496|NCT00320489|141315347|SUPERIORITY_OR_OTHER|||||||0.585||95.0|||||Log Rank|||||||0.585
70912497|NCT00320489|141315348|SUPERIORITY_OR_OTHER|||||||0.659||95.0|||||Fisher Exact|||||||0.659
70912498|NCT00320489|141315349|SUPERIORITY_OR_OTHER|||||||0.952||95.0|||||ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit Baseline.||||||0.952
70912499|NCT00320489|141315351|SUPERIORITY_OR_OTHER|||||||0.777||95.0||||P-value is for change from baseline to Week 104.|ANCOVA|Model: change = baseline, treatment, and investigator.||||||0.777
70912500|NCT00320489|141315352|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Fisher Exact|||||||0.530
70912501|NCT00320489|141315353|SUPERIORITY_OR_OTHER|||||||0.258||95.0||||P-value for fasting glucose.|Fisher Exact|||||||0.258
70912502|NCT00320489|141315353|SUPERIORITY_OR_OTHER|||||||0.688||95.0||||P-value is for fasting total cholesterol.|Fisher Exact|||||||0.688
70912503|NCT00320489|141315353|SUPERIORITY_OR_OTHER|||||||0.908||95.0||||P-value is for fasting triglycerides.|Fisher Exact|||||||0.908
70912504|NCT00320489|141315354|SUPERIORITY_OR_OTHER|||||||0.835||95.0|||||Fisher Exact|||||||0.835
70912505|NCT00320489|141315355|SUPERIORITY_OR_OTHER|||||||0.834||95.0||||P-value is for ALT.|Fisher Exact|||||||0.834
70912506|NCT00320489|141315355|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||P-value is for AST.|Fisher Exact|||||||0.723
70912507|NCT00320489|141315355|SUPERIORITY_OR_OTHER|||||||0.247||95.0||||P-value is for total bilirubin.|Fisher Exact|||||||0.247
70912508|NCT00320489|141315356|SUPERIORITY_OR_OTHER|||||||0.885||95.0|||||Fisher Exact|||||||0.885
70912509|NCT03441984|141315357|OTHER||Ratio of geometric LS means|1.6946|||||TWO_SIDED|90.0|1.569|1.8373|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented|||1.8373|1.5690|
70912510|NCT03441984|141315357|OTHER||Ratio of geometric LS means|1.3512|||||TWO_SIDED|90.0|1.2465|1.4647|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.4647|1.2465|
70912511|NCT03441984|141315357|OTHER||Ratio of geometric LS means|1.2541|||||TWO_SIDED|90.0|1.1569|1.3595|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented|||1.3595|1.1569|
70912512|NCT03441984|141315358|OTHER||Ratio of geometric LS means|1.7001|||||TWO_SIDED|90.0|1.5685|1.8428|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.8428|1.5685|
70912513|NCT03441984|141315358|OTHER||Ratio of geometric LS means|1.3519|||||TWO_SIDED|90.0|1.2475|1.465|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.4650|1.2475|
70912514|NCT03441984|141315358|OTHER||Ratio of geometric LS means|1.2576|||||TWO_SIDED|90.0|1.1605|1.3629|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.3629|1.1605|
70912515|NCT03441984|141315359|OTHER||Ratio of geometric LS means|1.7382|||||TWO_SIDED|90.0|1.5983|1.8904|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.8904|1.5983|
70912516|NCT03441984|141315359|OTHER||Ratio of geometric LS means|1.3614|||||TWO_SIDED|90.0|1.2525|1.4798|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.4798|1.2525|
70912517|NCT03441984|141315359|OTHER||Ratio of geometric LS means|1.2768|||||TWO_SIDED|90.0|1.1746|1.3878|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.3878|1.1746|
70912518|NCT03441984|141315360|OTHER||Ratio of geometric LS means|1.0407|||||TWO_SIDED|90.0|1.0118|1.0704|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0704|1.0118|
70912519|NCT03441984|141315360|OTHER||Ratio of geometric LS means|1.0228|||||TWO_SIDED|90.0|0.9944|1.052|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0520|0.9944|
70912520|NCT03441984|141315360|OTHER||Ratio of geometric LS means|1.0175|||||TWO_SIDED|90.0|0.9893|1.0465|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.0465|0.9893|
71092730|NCT00879658|141691860|SUPERIORITY|Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|lesion ratio|0.095|||<|0.001|TWO_SIDED|95.0|0.033|0.273||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||||0.273|0.033|<0.001
71092731|NCT00879658|141691860|SUPERIORITY||lesion ratio|0.18|||<|0.001|TWO_SIDED|95.0|0.069|0.47||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.470|0.069|<0.001
70912521|NCT03441984|141315361|OTHER||Ratio of geometric LS means|1.041|||||TWO_SIDED|90.0|1.0121|1.0708|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0708|1.0121|
70912522|NCT03441984|141315361|OTHER||Ratio of geometric LS means|1.0232|||||TWO_SIDED|90.0|0.9948|1.0524|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0524|0.9948|
70912523|NCT03441984|141315361|OTHER||Ratio of geometric LS means|1.0174|||||TWO_SIDED|90.0|0.9892|1.0465|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.0465|0.9892|
70912524|NCT03441984|141315362|OTHER||Ratio of geometric LS means|1.0533|||||TWO_SIDED|90.0|0.9885|1.1223|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.1223|0.9885|
70912525|NCT03441984|141315362|OTHER||Ratio of geometric LS means|0.9766|||||TWO_SIDED|90.0|0.9167|1.0405|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0405|0.9167|
70912526|NCT03441984|141315362|OTHER||Ratio of geometric LS means|1.0785|||||TWO_SIDED|90.0|1.0123|1.149|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.1490|1.0123|
70912527|NCT03441984|141315363|OTHER||Ratio of geometric LS means|1.0|||||TWO_SIDED|90.0|0.9536|1.0486|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0486|0.9536|
70912528|NCT03441984|141315363|OTHER||Ratio of geometric LS means|0.9478|||||TWO_SIDED|90.0|0.9039|0.9939|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||0.9939|0.9039|
70912529|NCT03441984|141315363|OTHER||Ratio of geometric LS means|1.055|||||TWO_SIDED|90.0|1.0061|1.1063|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.1063|1.0061|
70912530|NCT03441984|141315364|OTHER||Ratio of geometric LS means|0.9994|||||TWO_SIDED|90.0|0.9525|1.0486|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0486|0.9525|
70912531|NCT03441984|141315364|OTHER||Ratio of geometric LS means|0.9432|||||TWO_SIDED|90.0|0.899|0.9896|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||0.9896|0.8990|
70912532|NCT03441984|141315364|OTHER||Ratio of geometric LS means|1.0596|||||TWO_SIDED|90.0|1.0099|1.1117|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.1117|1.0099|
70912533|NCT03441984|141315365|OTHER||Ratio of geometric LS means|0.9362|||||TWO_SIDED|90.0|0.8677|1.0101|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0101|0.8677|
70912534|NCT03441984|141315365|OTHER||Ratio of geometric LS means|0.9079|||||TWO_SIDED|90.0|0.8416|0.9795|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||0.9795|0.8416|
70912535|NCT03441984|141315365|OTHER||Ratio of geometric LS means|1.0312|||||TWO_SIDED|90.0|0.9558|1.1124|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.1124|0.9558|
70912536|NCT03441984|141315366|OTHER||Ratio of geometric LS means|1.6439|||||TWO_SIDED|90.0|1.4649|1.8449|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.|||1.8449|1.4649|
70912537|NCT03441984|141315366|OTHER||Ratio of geometric LS means|1.2698|||||TWO_SIDED|90.0|1.1315|1.425|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.4250|1.1315|
70912538|NCT03441984|141315366|OTHER||Ratio of geometric LS means|1.2946|||||TWO_SIDED|90.0|1.1536|1.4529|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.4529|1.1536|
70912539|NCT03441984|141315367|OTHER||Ratio of geometric LS means|1.6578|||||TWO_SIDED|90.0|1.4709|1.8685|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.|||1.8685|1.4709|
70912540|NCT03441984|141315367|OTHER||Ratio of geometric LS means|1.2755|||||TWO_SIDED|90.0|1.1317|1.4375|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.4375|1.1317|
70912541|NCT03441984|141315367|OTHER||Ratio of geometric LS means|1.2998|||||TWO_SIDED|90.0|1.1533|1.465|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.4650|1.1533|
70912542|NCT03441984|141315368|OTHER||Ratio of geometric LS means|1.9758|||||TWO_SIDED|90.0|1.7585|2.2201|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.|||2.2201|1.7585|
70912543|NCT03441984|141315368|OTHER||Ratio of geometric LS means|1.2873|||||TWO_SIDED|90.0|1.1457|1.4465|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.4465|1.1457|
70912544|NCT03441984|141315368|OTHER||Ratio of geometric LS means|1.5348|||||TWO_SIDED|90.0|1.366|1.7245|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.7245|1.3660|
70912545|NCT03441984|141315369|OTHER||Ratio of geometric LS means|0.9798|||||TWO_SIDED|90.0|0.9241|1.0389|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.|||1.0389|0.9241|
70912546|NCT03441984|141315369|OTHER||Ratio of geometric LS means|0.9605|||||TWO_SIDED|90.0|0.9059|1.0185|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.0185|0.9059|
70912547|NCT03441984|141315369|OTHER||Ratio of geometric LS means|1.0201|||||TWO_SIDED|90.0|0.9633|1.0802|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.0802|0.9633|
70912548|NCT03441984|141315370|OTHER||Ratio of geometric LS means|0.9831|||||TWO_SIDED|90.0|0.9243|1.0457|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.|||1.0457|0.9243|
70912549|NCT03441984|141315370|OTHER||Ratio of geometric LS means|0.9702|||||TWO_SIDED|90.0|0.9121|1.032|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.0320|0.9121|
71092732|NCT00879658|141691860|SUPERIORITY||lesion ratio|0.173|||<|0.001|TWO_SIDED|95.0|0.069|0.434||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.434|0.069|<0.001
70912550|NCT03441984|141315370|OTHER||Ratio of geometric LS means|1.0134|||||TWO_SIDED|90.0|0.9527|1.0779|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.0779|0.9527|
70912551|NCT03441984|141315371|OTHER||Ratio of geometric LS means|0.91|||||TWO_SIDED|90.0|0.8196|1.0102|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.|||1.0102|0.8196|
70912552|NCT03441984|141315371|OTHER||Ratio of geometric LS means|0.9198|||||TWO_SIDED|90.0|0.8285|1.0212|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.0212|0.8285|
70912553|NCT03441984|141315371|OTHER||Ratio of geometric LS means|0.9893|||||TWO_SIDED|90.0|0.8911|1.0983|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.0983|0.8911|
70912554|NCT03441984|141315377|OTHER||Ratio of geometric LS means|1.6503|||||TWO_SIDED|90.0|1.5131|1.8|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.8000|1.5131|
70912555|NCT03441984|141315377|OTHER||Ratio of geometric LS means|1.3501|||||TWO_SIDED|90.0|1.2381|1.4722|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.4722|1.2381|
70912556|NCT03441984|141315377|OTHER||Ratio of geometric LS means|1.2224|||||TWO_SIDED|90.0|1.121|1.333|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.3330|1.1210|
70912557|NCT03441984|141315386|OTHER||Ratio of geometric LS means|1.0251|||||TWO_SIDED|90.0|0.848|1.2392|||||Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, 1 conventional tablet) is presented|||1.2392|0.8480|
71092733|NCT00879658|141691861|SUPERIORITY|Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|lesion ratio|0.259||||0.005|TWO_SIDED|95.0|0.1|0.67||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||||0.670|0.100|0.005
70912558|NCT03441984|141315386|OTHER||Ratio of geometric LS means|0.9181|||||TWO_SIDED|90.0|0.7592|1.1103|||||Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, 1 conventional tablet) is presented|||1.1103|0.7592|
70912559|NCT03441984|141315386|OTHER||Ratio of geometric LS means|1.1165|||||TWO_SIDED|90.0|0.9376|1.3295|||||Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) is presented|||1.3295|0.9376|
70912560|NCT03441984|141315394|OTHER||Ratio of geometric LS means|1.0844|||||TWO_SIDED|90.0|0.9904|1.1873|||||Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, 1 conventional tablet) is presented|||1.1873|0.9904|
70912561|NCT03441984|141315394|OTHER||Ratio of geometric LS means|1.1311|||||TWO_SIDED|90.0|1.0334|1.2379|||||Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, 1 conventional tablet) is presented|||1.2379|1.0334|
70912562|NCT03441984|141315394|OTHER||Ratio of geometric LS means|0.9587|||||TWO_SIDED|90.0|0.876|1.0493|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.0493|0.8760|
70912563|NCT03441984|141315402|OTHER||Ratio of geometric LS means|1.5619|||||TWO_SIDED|90.0|1.3678|1.7835|||||Treatment comparison between Pediatric DTG/3TC (DTG 5 mg/3TC 30 mg, 10 dispersible tablets) and Adult DTG (50 mg, 1 conventional tablet) and adult 3TC (300 mg, 1 conventional tablet) is presented|||1.7835|1.3678|
70912564|NCT03441984|141315402|OTHER||Ratio of geometric LS means|1.253|||||TWO_SIDED|90.0|1.0973|1.4307|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.4307|1.0973|
71092734|NCT00879658|141691861|SUPERIORITY||lesion ratio|0.276||||0.005|TWO_SIDED|95.0|0.112|0.676||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.676|0.112|0.005
70912565|NCT03441984|141315402|OTHER||Ratio of geometric LS means|1.2466|||||TWO_SIDED|90.0|1.0917|1.4234|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.4234|1.0917|
70912566|NCT03441984|141315411|OTHER||Ratio of geometric LS means|1.0745|||||TWO_SIDED|90.0|0.9997|1.1549|||||Treatment comparison between Pediatric DTG/3TC (DTG 5 mg/3TC 30 mg, 10 dispersible tablets) and Adult DTG (50 mg, 1 conventional tablet) and adult 3TC (300 mg, 1 conventional tablet) is presented|||1.1549|0.9997|
70912567|NCT03441984|141315411|OTHER||Ratio of geometric LS means|1.0706|||||TWO_SIDED|90.0|0.9961|1.1507|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.1507|0.9961|
70912568|NCT03441984|141315411|OTHER||Ratio of geometric LS means|1.0036|||||TWO_SIDED|90.0|0.9338|1.0787|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.0787|0.9338|
70912569|NCT00580801|141315501|SUPERIORITY_OR_OTHER||Least square mean ratio|0.98||||||90.0|0.54|1.78|||||Day 1: The least square (LS) means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.|||1.78|0.54|
70912570|NCT00580801|141315501|SUPERIORITY_OR_OTHER||Least square mean ratio|1.33||||||90.0|1.03|1.72|||||Day 15: The LS means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.|||1.72|1.03|
70912571|NCT00580801|141315502|SUPERIORITY_OR_OTHER||Least square mean ratio|1.0||||||90.0|0.58|1.72|||||Day 1: The LS means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.|||1.72|0.58|
70912572|NCT00580801|141315502|SUPERIORITY_OR_OTHER||Least square mean ratio|1.32||||||90.0|1.05|1.66|||||Day 15: The LS means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.|||1.66|1.05|
70912573|NCT00580801|141315503|SUPERIORITY_OR_OTHER||Least square mean ratio|1.43||||||90.0|1.02|2.02|||||Day 15: The LS means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.|||2.02|1.02|
70912574|NCT00580801|141315504|SUPERIORITY_OR_OTHER||Least square mean ratio|1.24||||||90.0|0.88|1.74|||||Day 15: The LS means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.|||1.74|0.88|
70912575|NCT02107014|141315518|SUPERIORITY_OR_OTHER|||||||0.576|||||||Mixed Models Analysis|||||||.576
70912576|NCT02107014|141315519|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mixed Models Analysis|||||||0.010
70912577|NCT02107014|141315520|SUPERIORITY_OR_OTHER|||||||0.008|||||||Mixed Models Analysis|||||||.008
70912578|NCT02107014|141315521|SUPERIORITY_OR_OTHER|||||||0.015|||||||Mixed Models Analysis|||||||.015
70912579|NCT02107014|141315522|SUPERIORITY_OR_OTHER|||||||0.007|||||||Mixed Models Analysis|||||||.007
70912580|NCT02107014|141315523|SUPERIORITY_OR_OTHER|||||||0.016|||||||Mixed Models Analysis|||||||.016
70912581|NCT02107014|141315524|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70912582|NCT02107014|141315525|SUPERIORITY_OR_OTHER|||||||0.212|||||||Mixed Models Analysis|||||||0.212
70912583|NCT02107014|141315528|SUPERIORITY_OR_OTHER|||||||0.008|||||||Mixed Models Analysis|||||||0.008
70912584|NCT02107014|141315529|SUPERIORITY_OR_OTHER|||||||0.004|||||||Mixed Models Analysis|||||||0.004
70912585|NCT02107014|141315530|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70912586|NCT02107014|141315531|SUPERIORITY_OR_OTHER|||||||0.047|||||||Mixed Models Analysis|||||||0.047
70912587|NCT02107014|141315532|SUPERIORITY_OR_OTHER|||||||0.002|||||||Mixed Models Analysis|||||||0.002
70912588|NCT02107014|141315533|SUPERIORITY_OR_OTHER|||||||0.003|||||||Mixed Models Analysis|||||||0.003
70912589|NCT02107014|141315534|SUPERIORITY_OR_OTHER|||||||0.191|||||||Mixed Models Analysis|||||||0.191
70912590|NCT02107014|141315535|SUPERIORITY_OR_OTHER|||||||0.088|||||||Mixed Models Analysis|||||||0.088
70912591|NCT02107014|141315536|SUPERIORITY_OR_OTHER|||||||0.478|||||||Mixed Models Analysis|||||||0.478
70912592|NCT02107014|141315539|SUPERIORITY_OR_OTHER|||||||0.016|||||||Mixed Models Analysis|||||||0.016
70912593|NCT02107014|141315540|SUPERIORITY_OR_OTHER|||||||0.025|||||||Mixed Models Analysis|||||||0.025
70912594|NCT02107014|141315541|SUPERIORITY_OR_OTHER|||||||0.012|||||||Mixed Models Analysis|||||||0.012
70912595|NCT02107014|141315542|SUPERIORITY_OR_OTHER|||||||0.426|||||||Mixed Models Analysis|||||||0.426
70912596|NCT02107014|141315543|SUPERIORITY_OR_OTHER|||||||0.042|||||||Mixed Models Analysis|||||||0.042
70912597|NCT02107014|141315544|SUPERIORITY_OR_OTHER|||||||0.708|||||||Mixed Models Analysis|||||||0.708
70912598|NCT02107014|141315545|SUPERIORITY_OR_OTHER|||||||0.558|||||||Mixed Models Analysis|||||||0.558
70912599|NCT02107014|141315546|SUPERIORITY_OR_OTHER|||||||0.35|||||||Mixed Models Analysis|||||||0.350
70912600|NCT02107014|141315547|SUPERIORITY_OR_OTHER|||||||0.655|||||||Mixed Models Analysis|||||||0.655
70912601|NCT02107014|141315548|SUPERIORITY_OR_OTHER|||||||0.248|||||||Mixed Models Analysis|||||||0.248
70912602|NCT02107014|141315549|SUPERIORITY_OR_OTHER|||||||0.128|||||||Mixed Models Analysis|||||||0.128
70912603|NCT02107014|141315550|SUPERIORITY_OR_OTHER|||||||0.065|||||||Mixed Models Analysis|||||||0.065
70912604|NCT02107014|141315551|SUPERIORITY_OR_OTHER|||||||0.962|||||||Mixed Models Analysis|||||||0.962
70912605|NCT02107014|141315552|SUPERIORITY_OR_OTHER|||||||0.402|||||||Mixed Models Analysis|||||||0.402
70912606|NCT02107014|141315553|SUPERIORITY_OR_OTHER|||||||0.201|||||||Mixed Models Analysis|||||||0.201
70912607|NCT02107014|141315554|SUPERIORITY_OR_OTHER|||||||0.016|||||||Mixed Models Analysis|||||||0.016
70912608|NCT02107014|141315555|SUPERIORITY_OR_OTHER|||||||0.006|||||||Mixed Models Analysis|||||||0.006
70912609|NCT02107014|141315556|SUPERIORITY_OR_OTHER|||||||0.007|||||||Mixed Models Analysis|||||||0.007
70912610|NCT02107014|141315557|SUPERIORITY_OR_OTHER|||||||0.038|||||||Mixed Models Analysis|||||||0.038
70912611|NCT02107014|141315558|SUPERIORITY_OR_OTHER|||||||0.032|||||||Mixed Models Analysis|||||||0.032
70912612|NCT02107014|141315559|SUPERIORITY_OR_OTHER|||||||0.002|||||||Mixed Models Analysis|||||||0.002
70912613|NCT02107014|141315561|SUPERIORITY_OR_OTHER|||||||0.508|||||||Mixed Models Analysis|||||||0.508
70912614|NCT02107014|141315562|SUPERIORITY_OR_OTHER|||||||0.119|||||||Mixed Models Analysis|||||||0.119
70912615|NCT02107014|141315563|SUPERIORITY_OR_OTHER|||||||0.326|||||||Mixed Models Analysis|||||||0.326
70912616|NCT02107014|141315564|SUPERIORITY_OR_OTHER|||||||0.753|||||||Mixed Models Analysis|||||||0.753
70912617|NCT02107014|141315565|SUPERIORITY_OR_OTHER|||||||0.067|||||||Mixed Models Analysis|||||||0.067
70912618|NCT02107014|141315566|SUPERIORITY_OR_OTHER|||||||0.08|||||||Mixed Models Analysis|||||||0.080
70912619|NCT02107014|141315567|SUPERIORITY_OR_OTHER|||||||0.639|||||||Mixed Models Analysis|||||||0.639
70912620|NCT02107014|141315570|SUPERIORITY_OR_OTHER|||||||0.945|||||||Mixed Models Analysis|||||||0.945
70912621|NCT02107014|141315571|SUPERIORITY_OR_OTHER|||||||0.038|||||||Mixed Models Analysis|||||||0.038
70912622|NCT02107014|141315572|SUPERIORITY_OR_OTHER|||||||0.281|||||||Mixed Models Analysis|||||||0.281
70912623|NCT02107014|141315573|SUPERIORITY_OR_OTHER|||||||0.03|||||||Mixed Models Analysis|||||||0.030
70912624|NCT02107014|141315574|SUPERIORITY_OR_OTHER|||||||0.948|||||||Mixed Models Analysis|||||||0.948
70912625|NCT02107014|141315575|SUPERIORITY_OR_OTHER|||||||0.61|||||||Mixed Models Analysis|||||||0.610
70912626|NCT02107014|141315576|SUPERIORITY_OR_OTHER|||||||0.893|||||||Mixed Models Analysis|||||||0.893
70912627|NCT02107014|141315577|SUPERIORITY_OR_OTHER|||||||0.041|||||||Mixed Models Analysis|||||||0.041
70912628|NCT02107014|141315580|SUPERIORITY_OR_OTHER|||||||0.967|||||||Mixed Models Analysis|||||||0.967
70912629|NCT02107014|141315581|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70912630|NCT02107014|141315582|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70912631|NCT01639443|141315628|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||"We counted days containing at least one Fast-tracked participant as a Fast-tracked day for the sake of analysis at the clinic level. Our null hypothesis is that these days will not differ in terms of percentage of clinic capacity filled. We are powered to detect a 0.5 Standard Deviation (SD) difference in clinic capacity (Type I error rate = 5%; Power = 81%), with a equal ratio of Experimental and Control days."||||<0.0001
70912632|NCT01639443|141315629|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||We calculated this measure on the patient level. Our null hypothesis is that the lag time between scheduling and appointment, measured in days, will not differ between groups. We are powered to detect a 0.3 SD difference in lag time (Type I error rate = 5%; Power = 84%), accounting for the large sampling ratio (approximately 14:1).||||0.29
70912633|NCT01639443|141315630|SUPERIORITY_OR_OTHER|||||||0.49||||||We would have only expected 2 patients to be bumped in the Experimental Group, and observed 0.|Fisher Exact|||We did not explicitly power this study to detect differences in the number of service bumps, but we can compare them using Fisher's Exact Test||||0.49
70912634|NCT01639443|141315631|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||We calculated this measure on the patient level, but were hampered by a large sampling ratio (more than 50:1). Our null hypothesis is that the number of polyps detected will not differ between groups. We are powered to detect a 0.25 SD difference in polyp count per patient (Type I error rate = 5%; Power = 80%).||||0.05
70912635|NCT01639443|141315632|SUPERIORITY_OR_OTHER|||||||0.024|||||||t-test, 2 sided|||"We counted days containing at least one Fast-tracked participant as a Fast-tracked day for the sake of analysis at the clinic level. Our null hypothesis is that these days will not differ in terms of length of workday. We are powered to detect approximately 0.5 SD difference in workday length in hours (Type I error rate = 5%; Power = 81%), with a equal ratio of Experimental and Control days."||||0.024
70912636|NCT01639443|141315633|SUPERIORITY_OR_OTHER|||||||0.11|||||||t-test, 2 sided|||"We counted days containing at least one Fast-tracked participant as a Fast-tracked day for the sake of analysis at the clinic level. Our null hypothesis is that these days will not differ in terms of cost per day. We are powered to detect a 0.5 SD difference in clinic capacity (Type I error rate = 5%; Power = 81%), with a equal ratio of Experimental and Control days."||||0.11
70912637|NCT01649427|141315634|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority||||||0.0003|||||||ANCOVA|||||||0.0003
70912638|NCT02138916|141315640|SUPERIORITY||Rate ratio|0.96||||0.649|TWO_SIDED|95.0|0.8|1.15|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.15|0.8|0.6490
70912639|NCT02138916|141315640|SUPERIORITY||Risk Ratio (RR)|0.83||||0.0525|TWO_SIDED|95.0|0.69|1.0|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.00|0.69|0.0525
70912640|NCT02138916|141315641|SUPERIORITY||Risk Ratio (RR)|1.07||||0.5236|TWO_SIDED|95.0|0.86|1.34|||Negative binomial|Model includes treatment group, region, number of exacerbations in the previous year.||||1.34|0.86|0.5236
70912641|NCT02138916|141315641|SUPERIORITY||Risk Ratio (RR)|1.02||||0.8812|TWO_SIDED|95.0|0.82|1.27|||Negative binomial|Model includes treatment group, EOS cohort, region, number of exacerbations in the previous year.||||1.27|0.82|0.8812
70912642|NCT02138916|141315642|SUPERIORITY||Mean Difference (Final Values)|0.007||||0.755|TWO_SIDED|95.0|-0.035|0.048|||Mixed Models Analysis|Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.048|-0.035|0.7550
70912643|NCT02138916|141315642|SUPERIORITY||Mean Difference (Final Values)|0.021||||0.3285|TWO_SIDED|95.0|-0.021|0.062|||Mixed Models Analysis|Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.062|-0.021|0.3285
70912644|NCT02138916|141315643|SUPERIORITY||Mean Difference (Final Values)|-1.011||||0.2906|TWO_SIDED|95.0|-2.887|0.865|||Mixed Models Analysis|Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.865|-2.887|0.2906
70912645|NCT02138916|141315643|SUPERIORITY||Mean Difference (Final Values)|-2.136||||0.0264|TWO_SIDED|95.0|-4.02|-0.251|||Mixed Models Analysis|Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.251|-4.020|0.0264
70912646|NCT02138916|141315644|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.6782|TWO_SIDED|95.0|-1.08|0.7|||Mixed Models Analysis|Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.70|-1.08|0.6782
70912647|NCT02138916|141315644|SUPERIORITY||Mean Difference (Final Values)|-0.81||||0.0753|TWO_SIDED|95.0|-1.7|0.08|||Mixed Models Analysis|Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.08|-1.70|0.0753
70912648|NCT02138916|141315645|SUPERIORITY||Mean Difference (Final Values)|-0.585||||0.0889|TWO_SIDED|95.0|-1.26|0.089|||Mixed Models Analysis|Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.089|-1.260|0.0889
70912649|NCT02138916|141315645|SUPERIORITY||Mean Difference (Final Values)|-0.703||||0.0413|TWO_SIDED|95.0|-1.378|-0.028|||Mixed Models Analysis|Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.028|-1.378|0.0413
70912650|NCT02138916|141315646|SUPERIORITY||Mean Difference (Final Values)|-0.348||||0.0728|TWO_SIDED|95.0|-0.728|0.032|||Mixed Models Analysis|Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.032|-0.728|0.0728
70912651|NCT02138916|141315646|SUPERIORITY||Mean Difference (Final Values)|-0.487||||0.0121|TWO_SIDED|95.0|-0.868|-0.107|||Mixed Models Analysis|Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.107|-0.868|0.0121
70912652|NCT02138916|141315647|SUPERIORITY||Mean Difference (Final Values)|-0.041||||0.0235|TWO_SIDED|95.0|-0.077|-0.006|||Mixed Models Analysis|Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.006|-0.077|0.0235
70912653|NCT02138916|141315647|SUPERIORITY||Mean Difference (Final Values)|-0.044||||0.0158|TWO_SIDED|95.0|-0.08|-0.008|||Mixed Models Analysis|Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.008|-0.080|0.0158
70912654|NCT02138916|141315651|SUPERIORITY||Rate ratio|1.09||||0.408|TWO_SIDED|95.0|0.89|1.34|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.34|0.89|0.4080
70912655|NCT02138916|141315651|SUPERIORITY||Rate ratio|0.98||||0.8688|TWO_SIDED|95.0|0.8|1.21|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.21|0.80|0.8688
70912656|NCT02138916|141315652|SUPERIORITY||Odds Ratio (OR)|0.9||||0.485|TWO_SIDED|95.0|0.66|1.22|||Cochran-Mantel-Haenszel|CMH test controlling for EOS cohort, region, and background therapy.||Proportion of participants with \>=1 COPD exacerbation.||1.22|0.66|0.4850
70912657|NCT02138916|141315652|SUPERIORITY||Odds Ratio (OR)|0.89||||0.4489|TWO_SIDED|95.0|0.65|1.21|||Cochran-Mantel-Haenszel|CMH test controlling for EOS cohort, region, and background therapy.||Proportion of participants with \>=1 COPD exacerbation.||1.21|0.65|0.4489
70912658|NCT02138916|141315654|SUPERIORITY||Rate ratio|1.06||||0.7733|TWO_SIDED|95.0|0.73|1.53|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).||||1.53|0.73|0.7733
70912659|NCT02138916|141315654|SUPERIORITY||Rate ratio|0.58||||0.0114|TWO_SIDED|95.0|0.39|0.89|||Nagative binomial|Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).||||0.89|0.39|0.0114
70912660|NCT05822440|141315665|OTHER||Ratio of Adjusted Geometric Means|124.35|||||TWO_SIDED|90.0|100.22|154.29||||||Ratio was between test to reference, where test is PF-07817883 + Itraconazole arm and reference is PF-07817883 arm. Natural log transformed Cmax of PF-07817883 were analyzed using a mixed effect model with treatment as fixed effect and participant as a random effect. The ratios (and 90% CIs) were expressed as percentages.||154.29|100.22|
70912661|NCT05822440|141315666|OTHER||Ratio of Adjusted Geometric Means|212.83||||||90.0|183.76|246.5||||||Ratio was between test to reference, where test is PF-07817883 + Itraconazole arm and reference is PF-07817883 arm. Natural log transformed Cmax of PF-07817883 were analyzed using a mixed effect model with treatment as fixed effect and participant as a random effect. The ratios (and 90% CIs) were expressed as percentages.||246.50|183.76|
70912662|NCT02387749|141315685|SUPERIORITY|||||||0.005|||||||Chi-squared, Corrected|||||||0.005
70912663|NCT04927975|141315702|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-7.6||||0.304|TWO_SIDED|95.0|-22.18|6.97|||Mixed-Effect Model Repeat Measurement|||Upa 6 mg Period 1 versus Placebo Period 1||6.97|-22.18|0.304
70912664|NCT04927975|141315702|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-21.27||||0.005|TWO_SIDED|95.0|-36.02|-6.52|||Mixed-Effect Model Repeat Measurement|||Upa 11 mg Period 1 versus Placebo Period 1||-6.52|-36.02|0.005
70912665|NCT04927975|141315702|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-19.6||||0.013|TWO_SIDED|95.0|-35.04|-4.16|||Mixed-Effect Model Repeat Measurement|||Upa 22 mg Period 1 versus Placebo Period 1||-4.16|-35.04|0.013
70912666|NCT04927975|141315703|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|6.9||||0.1|TWO_SIDED|95.0|-1.3|15.2|||Cochran-Mantel-Haenszel|||Upa 6 mg Period 1 versus Placebo Period 1||15.2|-1.3|0.100
70912667|NCT04927975|141315703|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|17.8||||0.002|TWO_SIDED|95.0|6.5|29.0|||Cochran-Mantel-Haenszel|||Upa 11 mg Period 1 versus Placebo Period 1||29.0|6.5|0.002
70912668|NCT04927975|141315703|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|11.7||||0.026|TWO_SIDED|95.0|1.4|21.9|||Cochran-Mantel-Haenszel|||Upa 22 mg Period 1 versus Placebo Period 1||21.9|1.4|0.026
70912669|NCT04927975|141315704|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|6.6||||0.327|TWO_SIDED|95.0|-6.6|19.7|||Cochran-Mantel-Haenszel|||Upa 6 mg Period 1 versus Placebo Period 1||19.7|-6.6|0.327
70912670|NCT04927975|141315704|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|29.3|||<|0.001|TWO_SIDED|95.0|13.8|44.9|||Cochran-Mantel-Haenszel|||Upa 11 mg Period 1 versus Placebo Period 1||44.9|13.8|<0.001
71092735|NCT00879658|141691861|SUPERIORITY||lesion ratio|0.118|||<|0.001|TWO_SIDED|95.0|0.034|0.409||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.409|0.034|<0.001
70912671|NCT04927975|141315704|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|28.7|||<|0.001|TWO_SIDED|95.0|12.6|44.7|||Cochran-Mantel-Haenszel|||Upa 22 mg Period 1 versus Placebo Period 1||44.7|12.6|<0.001
71092736|NCT00879658|141691861|SUPERIORITY||lesion ratio|0.683||||0.485|TWO_SIDED|95.0|0.234|1.991||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||1.991|0.234|0.485
71092737|NCT00879658|141691861|SUPERIORITY||lesion ratio|0.591||||0.142|TWO_SIDED|95.0|0.292|1.193||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||1.193|0.292|0.142
70912672|NCT04927975|141315705|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|3.7||||0.34|TWO_SIDED|95.0|-3.9|11.2|||Cochran-Mantel-Haenszel|||Upa 6 mg Period 1 versus Placebo Period 1||11.2|-3.9|0.340
70912673|NCT04927975|141315705|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|3.8||||0.358|TWO_SIDED|95.0|-4.3|11.8|||Cochran-Mantel-Haenszel|||Upa 11 mg Period 1 versus Placebo Period 1||11.8|-4.3|0.358
70912674|NCT04927975|141315705|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|9.1||||0.027|TWO_SIDED|95.0|1.0|17.2|||Cochran-Mantel-Haenszel|||Upa 22 mg Period 1 versus Placebo Period 1||17.2|1.0|0.027
70912675|NCT04927975|141315706|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-7.45||||0.12|TWO_SIDED|95.0|-16.86|1.96|||Mixed-Effect Model Repeat Measurement|||Upa 6 mg Period 1 versus Placebo Period 1||1.96|-16.86|0.120
70912676|NCT04927975|141315706|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-10.84||||0.026|TWO_SIDED|95.0|-20.37|-1.32|||Mixed-Effect Model Repeat Measurement|||Upa 11 mg Period 1 versus Placebo Period 1||-1.32|-20.37|0.026
70912677|NCT04927975|141315706|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-14.27||||0.005|TWO_SIDED|95.0|-24.24|-4.3|||Mixed-Effect Model Repeat Measurement|||Upa 22 mg Period 1 versus Placebo Period 1||-4.30|-24.24|0.005
70912678|NCT04927975|141315707|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-1.9||||0.545|TWO_SIDED|95.0|-8.3|4.4|||Mixed-Effect Model Repeat Measurement|||Upa 6 mg Period 1 versus Placebo Period 1||4.4|-8.3|0.545
70912679|NCT04927975|141315707|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|1.9||||0.565|TWO_SIDED|95.0|-4.5|8.3|||Mixed-Effect Model Repeat Measurement|||Upa 11 mg Period 1 versus Placebo Period 1||8.3|-4.5|0.565
70912680|NCT04927975|141315707|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-1.1||||0.754|TWO_SIDED|95.0|-7.8|5.6|||Mixed-Effect Model Repeat Measurement|||Upa 22 mg Period 1 versus Placebo Period 1||5.6|-7.8|0.754
70912681|NCT03184428|141315788|OTHER||||||<|0.05|||||||Spearman's rank-order correlation|Bonferroni adjustment in addition||||||<0.05
70912682|NCT02926937|141315811|SUPERIORITY||Difference in Least Squares (LS) Mean|-0.69|||<|0.0001|TWO_SIDED|95.0|-0.975|-0.415|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||-0.415|-0.975|<0.0001
70912683|NCT02926937|141315812|SUPERIORITY||Difference in LS Mean|-0.565||||0.0141|TWO_SIDED|95.0|-1.0166|-0.114|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, country, treatment-by-country as fixed effects, and baseline HbA1c as a covariate.||-0.1140|-1.0166|0.0141
71092738|NCT00879658|141691862|SUPERIORITY|Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|lesion ratio|0.161|||<|0.001|TWO_SIDED|95.0|0.062|0.421||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||||0.421|0.062|<0.001
70912684|NCT02926937|141315813|SUPERIORITY||Difference in LS Mean|-0.346||||0.2081|TWO_SIDED|95.0|-0.8853|0.1928|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups under Amendment 1 randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, country, treatment-by-country as fixed effects, and baseline HbA1c as a covariate.||0.1928|-0.8853|0.2081
70912685|NCT02926937|141315814|SUPERIORITY||Difference in LS Mean|-1.556|||<|0.0001|TWO_SIDED|95.0|-2.1876|-0.9234|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥ 130mmHg) at screening, and country as fixed effects, and baseline fasting plasma glucose as a covariate.||-0.9234|-2.1876|<0.0001
70912686|NCT02926937|141315815|SUPERIORITY||Difference in LS Mean|-3.5||||0.168|TWO_SIDED|95.0|-8.478|1.476|||ANCOVA|||The change from baseline to Week 12 is analyzed using analysis ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening and country as fixed effects, and baseline SBP as a covariate.||1.476|-8.478|0.1680
70912687|NCT02926937|141315816|SUPERIORITY||Difference in LS Mean|-0.78||||0.5467|TWO_SIDED|95.0|-3.311|1.753|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline SBP as a covariate.||1.753|-3.311|0.5467
71092739|NCT00879658|141691862|SUPERIORITY||lesion ratio|0.197||||0.001|TWO_SIDED|95.0|0.074|0.527||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.527|0.074|0.001
71092740|NCT00879658|141691862|SUPERIORITY||lesion ratio|0.416||||0.139|TWO_SIDED|95.0|0.13|1.331||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||1.331|0.130|0.139
71092741|NCT00879658|141691863|SUPERIORITY|||||||0.227||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.227
71153676|NCT00488683|141800054|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.31||||0.02||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup C||||0.02
71153677|NCT00488683|141800054|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.45||||0.002||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup W-135||||0.002
71153678|NCT00488683|141800054|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.4||||0.08||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup Y||||0.08
71153679|NCT00488683|141800054|SUPERIORITY_OR_OTHER||R-square|0.004||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup A||||
71092742|NCT00879658|141691863|SUPERIORITY|||||||0.02||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.020
71153680|NCT00488683|141800054|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup C||||
71153681|NCT00488683|141800054|SUPERIORITY_OR_OTHER||R-square|0.66||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup W-135||||
71153682|NCT00488683|141800054|SUPERIORITY_OR_OTHER||R-square|0.45||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup Y||||
71153683|NCT00488683|141800055|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.07||||0.7||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup A||||0.70
71153684|NCT00488683|141800055|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.13||||0.37||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup C||||0.37
71153685|NCT00488683|141800055|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.66|||<|0.0001||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup W-135||||<0.0001
71153686|NCT00488683|141800055|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.9|||<|0.0001||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup Y||||<0.0001
71153687|NCT00488683|141800055|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.01||||0.94||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup A||||0.94
70912688|NCT02926937|141315817|SUPERIORITY||Difference in LS Mean|-3.19||||0.0193|TWO_SIDED|95.0|-5.869|-0.518|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline SBP as a covariate.||-0.518|-5.869|0.0193
70912689|NCT02926937|141315818|SUPERIORITY||Difference in LS Mean|-1.54||||0.0005|TWO_SIDED|95.0|-2.404|-0.676|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline weight as a covariate.||-0.676|-2.404|0.0005
70912690|NCT02926937|141315819|SUPERIORITY||Difference in LS Mean|-1.17||||0.0406|TWO_SIDED|95.0|-2.281|-0.05|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130mmHg) at screening, and country as fixed effects, and baseline weight as a covariate.||-0.050|-2.281|0.0406
70912691|NCT02926937|141315820|SUPERIORITY||Percentage Difference|12.6||||0.0037|TWO_SIDED|95.0|4.18|21.02|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups from each stratum (randomization strata of HbA1c (\<=8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, \>=130 mmHg) at screening) using Cochran-Mantel-Haenszel weights.||21.02|4.18|0.0037
70912692|NCT02926937|141315821|SUPERIORITY||Percentage Difference|19.2||||0.0007|TWO_SIDED|95.0|8.39|30.0|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups from each stratum (randomization strata of HbA1c (\<=8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, \>=130 mmHg) at screening) using Cochran-Mantel-Haenszel weights.||30.00|8.39|0.0007
70912693|NCT02926937|141315822|SUPERIORITY||Difference in LS Mean|-0.67|||<|0.0001|TWO_SIDED|95.0|-0.989|-0.354|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||-0.354|-0.989|<0.0001
70912694|NCT00561574|141315827|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
70912695|NCT00561574|141315827|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
70912696|NCT00561574|141315828|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
70912697|NCT00561574|141315828|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
70912698|NCT00561574|141315829|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
70912699|NCT00561574|141315829|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
70912700|NCT00561574|141315830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3129||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||0.3129
70912701|NCT00561574|141315830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3154||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||0.3154
70912702|NCT00561574|141315831|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
70912703|NCT00561574|141315831|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
70912704|NCT00561574|141315832|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
71092743|NCT00879658|141691863|SUPERIORITY|||||||0.001||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.001
70912705|NCT00561574|141315832|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
70912706|NCT00561574|141315833|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
70912707|NCT00561574|141315833|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||0.0001
70912708|NCT00561574|141315834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0116||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||0.0116
70912709|NCT00561574|141315834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||0.0004
70912710|NCT05541497|141315968|SUPERIORITY||Risk Ratio (RR)|1.51|||||TWO_SIDED|95.0|0.68|3.37||||||||3.37|0.68|
70912711|NCT05541497|141315969|SUPERIORITY||Risk Ratio (RR)|1.36|||||TWO_SIDED|95.0|0.59|3.13||||||||3.13|0.59|
70912712|NCT00587288|141315972|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.194||0.0541|TWO_SIDED|95.0|-0.76|0.01||The p-value for the treatment comparison is based on the ANCOVA with adjustment for stratification factor and for variable at baseline.|ANCOVA|||||0.01|-0.76|0.0541
70912713|NCT00587288|141315973|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01||||0.0848|TWO_SIDED|95.0|0.91|4.46||The p-value for the treatment comparison was based on logistic regression with adjustment for stratification factor.|Regression, Logistic|||||4.46|0.91|0.0848
70912714|NCT00587288|141315974|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.077||0.0023|TWO_SIDED|95.0|0.088|0.392||The p-value for the treatment comparison was based on the ANCOVA with adjustment for stratification factor and for variable at baseline.|ANCOVA|||||0.392|0.088|0.0023
70912715|NCT00587288|141315975|SUPERIORITY_OR_OTHER||Adjusted mean difference|7.98|STANDARD_ERROR_OF_MEAN|2.36||0.001|TWO_SIDED|95.0|3.3|12.65||The p-value for the treatment comparison was based on the ANCOVA with adjustment for stratification factor and for variable at baseline.|ANCOVA|||||12.65|3.30|0.0010
70912716|NCT00587288|141315976|SUPERIORITY_OR_OTHER||Adjusted mean difference|-125.29|STANDARD_ERROR_OF_MEAN|44.885||0.0068|TWO_SIDED|95.0|-214.81|-35.77||The p-value for the treatment comparison was based on the ANCOVA with adjustment for stratification factor and for variable at baseline. The difference between reslizumab 3.0 mg/kg and placebo groups was from comparison of the least square means.|ANCOVA|||||-35.77|-214.81|0.0068
70912717|NCT00587288|141315977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.33||||0.0833|TWO_SIDED|95.0|0.1|1.15||The p-value for the treatment comparison was based on logistic regression with adjustment for stratification factor.|Regression, Logistic|||||1.15|0.10|0.0833
70912718|NCT00587288|141315977|SUPERIORITY_OR_OTHER|||||||0.0809|||||||Log Rank|The p value for the treatment comparison was based on log rank test adjusting for stratification factor (ie, ACQ score ≤2 and \>2).||"Kaplan-Meier estimate of time to first CAE. (First quartile, median and third quartile survival times with 95% confidence intervals (ie, time to first CAE) could not be estimated since the proportion of patients experiencing CAE was too low. Therefore, the only number presented in regard to the Kaplan-Meier analysis is the p-value of the log-rank test, below. )"||||0.0809
70912719|NCT00531479|141315986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.74||||0.0434|TWO_SIDED|95.0|-18.99|1.51||P-value based on a 1-sided test and tested against a 1-sided alpha of 0.025 to determine statistical significance.|Z test for difference in proportions||The 95% CI was based on using Greenwood's formula for the variance of the KM estimator.|All-cause mortality calculated using the Kaplan-Meier (KM) product limit estimator on Day 42 (Week 6) within each stratum and weighted by the harmonic mean of the sample sizes in the strata. Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables were site of infection and host factors.||1.51|-18.99|0.0434
70912720|NCT00531479|141315987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.23|||||TWO_SIDED|95.0|-21.6|1.15||P-value for global response was to be reported only if Week 6 mortality was significant.|||95% confidence interval based on the difference in success rates using the normal approximation to the binoial distribution.|Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables: site of infection and host factors.||1.15|-21.6|
70912721|NCT00531479|141315988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.2611|TWO_SIDED|95.0|-10.77|5.56||P-Value based on a 1-sided test and tested against a 1-sided alpha of 0.025 to determine statistical significance.|Z test for difference in proportions||95% confidence interval based on using Greenwood's formula for the variance of the Kaplan Meier estimator.|Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables: site of infection and host factors.||5.56|-10.77|0.2611
70912722|NCT00531479|141315989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.18||||0.0383|TWO_SIDED|95.0|-21.44|1.09||P-Value based on a 1-sided test and tested against a 1-sided alpha of 0.025 to determine statistical significance.|Z test for difference in proportions||95% confidence intervalbased on using Greenwood's formula for the variance of the Kaplan Meier estimator.|Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables: site of infection and host factors.||1.09|-21.44|0.0383
70912723|NCT00531479|141315990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.24||||0.1029|TWO_SIDED|95.0|-15.9|3.42||P-Value based on a one-sided test and tested against a 1-sided alpha of 0.025 to determine statistical significance.|Z test for difference in proportions||95% confidence interval based on Greenwood's formula for the variance of the Kaplan Meier estimator.|Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables: site of infection and host factors.||3.42|-15.9|0.1029
70912724|NCT00531479|141315991|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.696||||0.083|TWO_SIDED|95.0|0.46|1.04|||Cox proportional hazards model|||Hazard Ratio: hazard of death in the Voriconazole/Anidulafungin arm relative to the Voriconazole/Placebo arm, adjusted for host factor status and site of infection. Participants who died beyond Day 84 were censored.||1.04|0.46|0.083
70912725|NCT00531479|141315992|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.687||||0.164|TWO_SIDED|95.0|0.4|1.16|||Cox proportional hazards model||95% confidence interval based on Greenwood's formula.|Analysis based on Cox proportional hazards model. Participants who died beyond day 84 were censored.||1.16|0.40|0.164
70912726|NCT01743729|141315993|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|0.03||||0.6186|TWO_SIDED|95.0|-0.1|0.17|||ANCOVA|||||0.17|-0.10|0.6186
70912727|NCT01743729|141315994|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|12.61|||<|0.0001|TWO_SIDED|95.0|8.51|16.7|||ANCOVA|||||16.70|8.51|<0.0001
70912728|NCT05642000|141315995|SUPERIORITY||Odds Ratio, log|0.187|STANDARD_ERROR_OF_MEAN|0.136|||TWO_SIDED|95.0|-0.079|0.454|||Mixed Models Analysis|||||0.454|-0.079|
70912729|NCT01474538|141316032|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 95% confidence interval (CI) was below 0.4%, lispro was declared non-inferior to aspart.|LS Mean difference|0.1|||||TWO_SIDED|95.0|-0.002|0.21|||Mixed Models Analysis|||||0.210|-0.002|
71092744|NCT00879658|141691863|SUPERIORITY|||||||0.122||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.122
70912730|NCT01474538|141316033|SUPERIORITY_OR_OTHER||LS Mean difference|-0.28|||||TWO_SIDED|95.0|-2.92|2.35|||Mixed Models Analysis|||||2.35|-2.92|
70912731|NCT01474538|141316034|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.94||||0.522|||||||Negative binomial|||||||0.522
70912732|NCT01474538|141316035|SUPERIORITY_OR_OTHER||LS Mean difference|-0.58||||0.216|||||||Grizzle Model|||||||0.216
70912733|NCT01474538|141316036|SUPERIORITY_OR_OTHER|||||||0.471|||||||Prescott test|||||||0.471
70912734|NCT02501629|141316049|SUPERIORITY||Odds Ratio (OR)|1.23||||0.468|TWO_SIDED|95.0|0.702|2.157||Significance at 0.05.|proportional odds model|factors for treatment group and randomization strata (age and OCS dose); baseline OCS dose and duration of OCS use prior to study were covariates.||The proportional odds ratio (reslizumab/placebo) was estimated from this model, representing the ratio of the odds of a patient outcome being in a higher OCS dose reduction category for reslizumab compared to placebo.||2.157|0.702|0.468
70912735|NCT02501629|141316050|SUPERIORITY||Odds Ratio (OR)|1.45||||0.234|TWO_SIDED|95.0|0.786|2.683||significance at 0.05.|Regression, Logistic|logistic regression model adjusted for treatment, stratification factors (age group and OCS dose group), duration of OCS use, and baseline value.||As the analysis of the primary efficacy endpoint did not meet criteria for statistical significance (p≤0.05), the secondary efficacy endpoints were not interpreted inferentially according to the pre-defined hierarchy. P-values are nominal, meaning they were obtained from the analysis without adjustments to protect family-wise errors and should be interpreted with caution. Nominal p-values do not indicate treatment differences.||2.683|0.786|0.234
70970610|NCT00531752|141447058|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9211|STANDARD_ERROR_OF_MEAN|2.8206||0.3034|TWO_SIDED|80.0|-0.7227|6.5648|||Mixed Models Analysis|||Week 3 (R/C): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.5648|-0.7227|0.3034
70912736|NCT02501629|141316051|SUPERIORITY||Odds Ratio (OR)|1.19||||0.596|TWO_SIDED|95.0|0.631|2.229||significance at 0.05.|Regression, Logistic|logistic regression model adjusted for treatment, stratification factors (age group and OCS dose group), duration of OCS use, and baseline value.||As the analysis of the primary efficacy endpoint did not meet criteria for statistical significance (p≤0.05), the secondary efficacy endpoints were not interpreted inferentially according to the pre-defined hierarchy. P-values are nominal, meaning they were obtained from the analysis without adjustments to protect family-wise errors and should be interpreted with caution. Nominal p-values do not indicate treatment differences.||2.229|0.631|0.596
70912737|NCT02501629|141316052|SUPERIORITY||Mean Difference (Final Values)|-17.75|STANDARD_ERROR_OF_MEAN|10.759||0.101|TWO_SIDED|95.0|-38.986|3.494|||mixed model repeated measures (MMRM)||Reslizumab - Placebo|Mixed model repeated measures (MMRM) with fixed effects for treatment, visit, treatment by visit interaction, age group, and OCS dose group, duration of OCS use and baseline value as covariates, and patient as a random effect. Unstructured covariance was assumed for the repeated measures.||3.494|-38.986|0.101
70912738|NCT02501629|141316053|SUPERIORITY||Odds Ratio (OR)|1.36||||0.341|TWO_SIDED|95.0|0.722|2.562||significance at 0.05.|Regression, Logistic|logistic regression model adjusted for treatment, stratification factors (age group and OCS dose group), duration of OCS use, and baseline value.||As the analysis of the primary efficacy endpoint did not meet criteria for statistical significance (p≤0.05), the secondary efficacy endpoints were not interpreted inferentially according to the pre-defined hierarchy. P-values are nominal, meaning they were obtained from the analysis without adjustments to protect family-wise errors and should be interpreted with caution. Nominal p-values do not indicate treatment differences.||2.562|0.722|0.341
70912739|NCT02501629|141316054|SUPERIORITY||CAE rate ratio|0.82||||0.407|TWO_SIDED|95.0|0.504|1.321|||Negative binomial regression model|Negative binomial regression model adjusted for stratification factors (OCS dose group), age, number of prior exacerbations, and an offset variable.|reslizumab vs placebo|||1.321|0.504|0.407
70912740|NCT02501629|141316055|SUPERIORITY||Odds Ratio (OR)|0.82||||0.628|TWO_SIDED|95.0|0.371|1.818||significance at 0.05.|Regression, Logistic|logistic regression model adjusted for treatment, stratification factors (age group and OCS dose group), duration of OCS use, and baseline value.||As the analysis of the primary efficacy endpoint did not meet criteria for statistical significance (p≤0.05), the secondary efficacy endpoints were not interpreted inferentially according to the pre-defined hierarchy. P-values are nominal, meaning they were obtained from the analysis without adjustments to protect family-wise errors and should be interpreted with caution. Nominal p-values do not indicate treatment differences.||1.818|0.371|0.628
70912741|NCT02004613|141316060|SUPERIORITY||Risk Ratio (RR)|0.91||||0.34|TWO_SIDED|97.8|0.72|1.15|||Regression, Logistic|||Hypothesis: dexmedetomidine would reduce the incidence of postoperative atrial arrhythmias.||1.15|0.72|0.34
70912742|NCT02004613|141316061|SUPERIORITY||Risk Ratio (RR)|1.48||||0.026|TWO_SIDED|97.8|0.99|2.23|||Regression, Logistic|||hypothesis: Dexmedetomidine may reduce the incidence of postoperative delirium.||2.23|0.99|0.026
70912743|NCT02004613|141316062|SUPERIORITY||Risk Ratio (RR)|1.4||||0.14|TWO_SIDED|97.5|0.84|2.34|||Regression, Logistic|||||2.34|0.84|0.14
71092745|NCT00879658|141691863|SUPERIORITY|||||||0.034||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.034
70912744|NCT02004613|141316063|OTHER||Risk Ratio (RR)|0.87||||0.29|TWO_SIDED|97.5|0.65|1.16|||Regression, Logistic|||||1.16|0.65|0.29
70912745|NCT05349864|141316103|EQUIVALENCE|Using data from Treatment A and Treatment B, natural log transformed AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model, and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios.|ratio of adjusted geometric means|120.25|||||TWO_SIDED|90.0|109.76|131.75||||||||131.75|109.76|
70912746|NCT05349864|141316104|EQUIVALENCE|Using data from Treatment A and Treatment B, natural log transformed AUCinf was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model, and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios.|ratio of adjusted geometric means|116.22|||||TWO_SIDED|90.0|97.91|137.95||||||||137.95|97.91|
70912747|NCT05349864|141316105|EQUIVALENCE|Using data from Treatment A and Treatment B, natural log transformed Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model, and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios.|ratio of adjusted geometric means|206.91|||||TWO_SIDED|90.0|171.14|250.15||||||||250.15|171.14|
70912748|NCT05349864|141316106|EQUIVALENCE|Using data from Treatment A and Treatment C, natural log transformed AUClast was analyzed using a mixed effect model with treatment and sequence as a fixed effect and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model, and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios.|ratio of adjusted geometric means|135.77|||||TWO_SIDED|90.0|114.36|161.19||||||||161.19|114.36|
71092746|NCT00879658|141691864|SUPERIORITY|||||||0.335||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.335
71092747|NCT00879658|141691864|SUPERIORITY|||||||0.022||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.022
71092748|NCT00879658|141691864|SUPERIORITY|||||||0.124||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.124
70912749|NCT05349864|141316107|EQUIVALENCE|Using data from Treatment A and Treatment C, natural log transformed AUCinf was analyzed using a mixed effect model with treatment and sequence as a fixed effect and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model, and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios.|ratio of adjusted geometric means|138.36|||||TWO_SIDED|90.0|106.11|180.41||||||||180.41|106.11|
70912750|NCT05349864|141316108|EQUIVALENCE|Using data from Treatment A and Treatment C, natural log transformed Cmax was analyzed using a mixed effect model with treatment and sequence as a fixed effect and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model, and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios.|ratio of adjusted geometric means|236.58|||||TWO_SIDED|90.0|190.12|294.38||||||||294.38|190.12|
70912751|NCT00984282|141316117|SUPERIORITY_OR_OTHER||||||<|0.0001||||||stratified by age group (\< 60 years, \>= 60 years) and region (Europe, North-America, Asia)|Log Rank|||The two treatment groups were compared using a stratified one-sided log rank test with an overall alpha of 0.01 stratified by age group and region. The null hypothesis that both treatment arms have the same PFS distribution will be tested against the alternative hypothesis that the distribution of PFS times in the sorafenib arm is different from the control arm according to the Lehmann alternative, which is equivalent to the assumption of proportional hazards of the treatment arms.||||<0.0001
70912752|NCT00984282|141316117|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.587|||||TWO_SIDED|95.0|0.454|0.758|||Regression, Cox|stratified by age group and region||||0.758|0.454|
70912753|NCT00984282|141316118|SUPERIORITY_OR_OTHER|||||||0.2892|||||||Log Rank|stratified by age group and region||||||0.2892
70912754|NCT00984282|141316118|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.928|||||TWO_SIDED|95.0|0.713|1.208|||Regression, Cox|stratified by age group and region||||1.208|0.713|
70912755|NCT00984282|141316119|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|stratified by age group and region||||||<0.0001
70912756|NCT00984282|141316119|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.557|||||TWO_SIDED|95.0|0.429|0.724|||Regression, Cox|stratified by age group and region||||0.724|0.429|
70912757|NCT00984282|141316120|SUPERIORITY_OR_OTHER||Difference of response rates|11.7||||0.0015|TWO_SIDED|95.0|3.9|19.4||stratified by age group and region|Cochran-Mantel-Haenszel||Difference of disease control rates sorafenib minus placebo. Cochran-Mantel-Haenszel confidence interval stratified by age group and region|||19.4|3.9|0.0015
70912758|NCT00984282|141316121|SUPERIORITY_OR_OTHER||Difference in response rate|11.8|||<|0.0001|TWO_SIDED|95.0|7.0|16.5||stratified by age group and region|Cochran-Mantel-Haenszel||Difference of response rates sorafenib minus placebo. Cochran-Mantel-Haenszel confidence interval stratified by age group and region|||16.5|7.0|<0.0001
70912759|NCT02359435|141316135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.016|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
70912760|NCT01549314|141316142|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||Change from baseline to 24 months in cortical volumentric bone mineral density was determined and compared between subjects with CF taking ivacaftor and subjects with CF not taking ivacaftor.||||0.77
70912761|NCT01549314|141316142|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||Change from baseline to 24 months in cortical volumentric bone mineral density was determined and compared between subjects with CF not taking ivacaftor and healthy subjects.||||0.82
70912762|NCT01549314|141316143|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||Change from baseline to 24 months in DXA PA spine bone mineral density was determined and compared between subjects with CF taking ivacaftor and subjects with CF not taking ivacaftor.||||0.64
70912763|NCT01549314|141316143|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||Change from baseline to 24 months in DXA PA spine bone mineral density was determined and compared between subjects with CF not taking ivacaftor and healthy subjects.||||0.78
70912764|NCT01549314|141316144|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|||Change from baseline to 24 months in osteocalcin was determined and compared between subjects with CF taking ivacaftor and subjects with CF not taking ivacaftor.||||0.86
70912765|NCT01549314|141316144|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||Change from baseline to 24 months in osteocalcin was determined and compared between subjects with CF not taking ivacaftor and healthy subjects.||||0.99
70912766|NCT01289119|141316150|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58|||<|0.001|TWO_SIDED|95.0|-0.78|-0.37|||ANCOVA|ANCOVA model with treatment as a fixed effect, and baseline HbA1c as a covariate.||The analysis was conducted at the 2-sided 5% significance level without a multiplicity adjustment.||-0.37|-0.78|<0.001
70912767|NCT01289119|141316150|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.69|||<|0.001|TWO_SIDED|95.0|-0.87|-0.51||ANCOVA model with treatment as a fixed effect, and baseline HbA1c with baseline metformin dose as covariates.|ANCOVA|||The analysis was conducted at the 2-sided 5% significance level without a multiplicity adjustment.||-0.51|-0.87|<0.001
70912768|NCT01289119|141316150|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.75|-0.28|||ANCOVA|ANCOVA model with treatment as a fixed effect, and baseline HbA1c with baseline metformin therapy status and baseline pioglitazone dose as covariates.||The analysis was conducted at the 2-sided 5% significance level without a multiplicity adjustment.||-0.28|-0.75|<0.001
70912769|NCT01704846|141316162|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|100.47|||||TWO_SIDED|90.0|95.9|105.25|||||Ratio calculated as Test product divided by reference product|||105.25|95.90|
70912770|NCT01704846|141316163|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|102.99|||||TWO_SIDED|90.0|95.57|110.98|||||Ratio calculated as Test product divided by reference product|||110.98|95.57|
70912771|NCT01704846|141316164|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|100.54|||||TWO_SIDED|90.0|96.1|105.18|||||Ratio calculated as Test product divided by reference product|||105.18|96.10|
70912772|NCT01704846|141316165|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the adjusted mean ratio was 80 to 125%.|Adjusted Mean Ratio (%)|97.66|||||TWO_SIDED|90.0|91.54|103.78|||||Ratio calculated as Test product divided by reference product|||103.78|91.54|
70912773|NCT01704846|141316166|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|100.34|||||TWO_SIDED|90.0|98.51|102.2|||||Ratio calculated as Test product divided by reference product|||102.20|98.51|
70912774|NCT01704846|141316167|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|99.66|||||TWO_SIDED|90.0|97.85|101.51|||||Ratio calculated as Test product divided by reference product|||101.51|97.85|
70912775|NCT01704846|141316168|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|100.2|||||TWO_SIDED|90.0|98.1|102.34|||||Ratio calculated as Test product divided by reference product|||102.34|98.10|
70912776|NCT00530335|141316170|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in Total ADHD Symptoms Score (endpoint - baseline).|t-test, 2 sided|||||||<0.001
70912777|NCT00530335|141316170|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in Inattentive Subscale scores (endpoint - baseline).|t-test, 2 sided|||||||<0.001
70912778|NCT00530335|141316170|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in Hyperactivity/Impulsive Subscale scores (endpoint - baseline).|t-test, 2 sided|||||||<0.001
70912779|NCT00530335|141316170|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in ADHD Index Subscale scores (endpoint - baseline).|t-test, 2 sided|||||||<0.001
70912780|NCT00530335|141316171|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in Total ADHD Symptoms Score (endpoint - baseline).|t-test, 2 sided|||||||<0.001
70912781|NCT00530335|141316171|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in Inattentive Subscale scores (endpoint - baseline).|t-test, 2 sided|||||||<0.001
70912782|NCT00530335|141316171|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in Hyperactive/Impulsive Subscale scores (endpoint - baseline).|t-test, 2 sided|||||||<0.001
70912783|NCT00530335|141316171|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in ADHD Index Subscale scores (endpoint - baseline).|t-test, 2 sided|||||||<0.001
70912784|NCT00530335|141316172|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
70912785|NCT00530335|141316173|SUPERIORITY_OR_OTHER|||||||0.749||95.0|||||t-test, 2 sided|||||||0.749
70912786|NCT00530335|141316174|SUPERIORITY_OR_OTHER|||||||0.886||95.0|||||t-test, 2 sided|||||||0.886
70912787|NCT00530335|141316176|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for comparing differences in Word Test number of correct responses (endpoint - baseline).|t-test, 2 sided|||||||0.005
70912788|NCT00530335|141316176|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for comparing differences in Color Test number of correct responses (endpoint - baseline).|t-test, 2 sided|||||||<0.001
70912789|NCT00530335|141316176|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for comparing differences in Color-Word Test number of correct responses (endpoint - baseline).|t-test, 2 sided|||||||0.003
70912790|NCT01268891|141316217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.35||0.3257|TWO_SIDED|90.0|-0.93|0.23||The threshold for statistical significance in showing a trend for this study is 0.10.|ANCOVA|||The power for this study, which is designed to show a trend, that is, to show a clinical difference in the primary outcome measure, is 72%.||0.23|-0.93|0.3257
70912791|NCT01268891|141316218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.0946|TWO_SIDED|95.0|-0.65|0.05|||ANCOVA|||||0.05|-0.65|0.0946
70912792|NCT01268891|141316219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.57||0.2258|TWO_SIDED|95.0|-1.84|0.44|||ANCOVA|||||0.44|-1.84|0.2258
70912793|NCT01268891|141316220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|0.98||0.17|TWO_SIDED|95.0|-3.29|0.59|||ANCOVA|||||0.59|-3.29|0.1700
70912794|NCT00991276|141316221|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-27.1|STANDARD_ERROR_OF_MEAN|4.38|<|0.0001|TWO_SIDED|95.0|-35.78|-18.42||This analysis was step 1 in a step-down procedure (if p-value \< 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The least squares (LS) means and standard errors (SE) were used to test for a treatment difference and construct 2-sided 95% confidence intervals (CIs). The hypothesis test was 2-sided and conducted at the 5% level of significance.||-18.42|-35.78|<0.0001
70912795|NCT00991276|141316221|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-26.93|STANDARD_ERROR_OF_MEAN|4.35|<|0.0001|TWO_SIDED|95.0|-35.54|-18.32||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-18.32|-35.54|<0.0001
70912796|NCT00991276|141316221|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|4.32||0.9684|TWO_SIDED|95.0|-8.72|8.38||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||8.38|-8.72|0.9684
71153688|NCT00488683|141800055|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.05||||0.7||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup C||||0.70
70912797|NCT00991276|141316222|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.68|STANDARD_ERROR_OF_MEAN|0.89|<|0.0001|TWO_SIDED|95.0|-5.44|-1.92||This analysis was step 2 in a step-down procedure (if p-value \< 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.92|-5.44|<0.0001
70912798|NCT00991276|141316222|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.26|STANDARD_ERROR_OF_MEAN|0.88||0.1541|TWO_SIDED|95.0|-0.48|3.01||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||3.01|-0.48|0.1541
70912799|NCT00991276|141316222|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.94|STANDARD_ERROR_OF_MEAN|0.88|<|0.0001|TWO_SIDED|95.0|-6.68|-3.21||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-3.21|-6.68|<0.0001
70912800|NCT00991276|141316223|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|30.81|STANDARD_ERROR_OF_MEAN|7.42|<|0.0001|TWO_SIDED|95.0|16.14|45.49||This analysis was step 3 in a step-down procedure (if p-value \< 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||45.49|16.14|<0.0001
70912801|NCT00991276|141316223|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|26.79|STANDARD_ERROR_OF_MEAN|7.34||0.0004|TWO_SIDED|95.0|12.26|41.32||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||41.32|12.26|0.0004
70912802|NCT00991276|141316223|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.03|STANDARD_ERROR_OF_MEAN|7.27||0.5807|TWO_SIDED|95.0|-10.36|18.41||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||18.41|-10.36|0.5807
70912803|NCT00991276|141316224|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.67|STANDARD_ERROR_OF_MEAN|2.09||0.0076|TWO_SIDED|95.0|-9.8|-1.54||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N1 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.54|-9.80|0.0076
70912804|NCT00991276|141316224|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-10.32|STANDARD_ERROR_OF_MEAN|2.08|<|0.0001|TWO_SIDED|95.0|-14.43|-6.21||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N1 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-6.21|-14.43|<0.0001
70912805|NCT00991276|141316224|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.65|STANDARD_ERROR_OF_MEAN|2.06||0.0257|TWO_SIDED|95.0|0.58|8.73||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N1 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||8.73|0.58|0.0257
70912806|NCT00991276|141316224|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|22.7|STANDARD_ERROR_OF_MEAN|6.05||0.0003|TWO_SIDED|95.0|10.74|34.67||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N2 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||34.67|10.74|0.0003
70970611|NCT00531752|141447058|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.0968|STANDARD_ERROR_OF_MEAN|3.0022||0.0933|TWO_SIDED|80.0|-8.975|-1.218|||Mixed Models Analysis|||Week 3 (R/C): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.218|-8.975|0.0933
71153689|NCT00488683|141800055|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.3||||0.04||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup W-135||||0.04
71092749|NCT00879658|141691865|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.129||||0.006|TWO_SIDED|95.0|0.03|0.561||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||0.561|0.030|0.006
71153690|NCT00488683|141800055|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.46||||0.004||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup Y||||0.004
71153691|NCT00488683|141800055|SUPERIORITY_OR_OTHER||R-square|0.005||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup A||||
71153692|NCT00488683|141800055|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup C||||
71153693|NCT00488683|141800055|SUPERIORITY_OR_OTHER||R-square|0.43||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup W-135||||
71092750|NCT00879658|141691865|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.159||||0.005|TWO_SIDED|95.0|0.044|0.578||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||0.578|0.044|0.005
71092751|NCT00879658|141691865|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.052||||0.005|TWO_SIDED|95.0|0.007|0.405||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||0.405|0.007|0.005
71092752|NCT00879658|141691865|SUPERIORITY||lesion ratio|0.271||||0.019|TWO_SIDED|95.0|0.091|0.807||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.||0.807|0.091|0.019
71092753|NCT00879658|141691865|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.504||||0.169|TWO_SIDED|95.0|0.19|1.337||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||1.337|0.190|0.169
71092754|NCT00879658|141691866|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.214|||<|0.001|TWO_SIDED|95.0|0.091|0.499||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||0.499|0.091|<0.001
71092755|NCT00879658|141691866|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.24||||0.018|TWO_SIDED|95.0|0.074|0.779||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||0.779|0.074|0.018
71092756|NCT00879658|141691866|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.231||||0.006|TWO_SIDED|95.0|0.081|0.653||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||0.653|0.081|0.006
71153694|NCT00488683|141800055|SUPERIORITY_OR_OTHER||R-square|0.82||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup Y||||
71153695|NCT00488683|141800055|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.05||||0.68||95.0||||Values from Group 1, 2 and 2 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup A||||0.68
71153696|NCT00488683|141800055|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.08||||0.46||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup C||||0.46
71153697|NCT00488683|141800055|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.2||||0.08||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||0.08
71153698|NCT00488683|141800055|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.45|||<|0.001||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||<0.001
70912807|NCT00991276|141316224|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-14.47|STANDARD_ERROR_OF_MEAN|6.0||0.0174|TWO_SIDED|95.0|-26.35|-2.59||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N2 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-2.59|-26.35|0.0174
70912808|NCT00991276|141316224|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|37.17|STANDARD_ERROR_OF_MEAN|5.96|<|0.0001|TWO_SIDED|95.0|25.38|48.96||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N2 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||48.96|25.38|<0.0001
70912809|NCT00991276|141316224|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|20.93|STANDARD_ERROR_OF_MEAN|4.2|<|0.0001|TWO_SIDED|95.0|12.61|29.25||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N3 sleep/SWS: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||29.25|12.61|<0.0001
70912810|NCT00991276|141316224|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|32.1|STANDARD_ERROR_OF_MEAN|4.18|<|0.0001|TWO_SIDED|95.0|23.83|40.36||This analysis was step 4 in a step-down procedure (if p-value \< 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||Stage N3 sleep/SWS: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||40.36|23.83|<0.0001
70912811|NCT00991276|141316224|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-11.17|STANDARD_ERROR_OF_MEAN|4.14||0.008|TWO_SIDED|95.0|-19.37|-2.97||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N3 sleep/SWS: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-2.97|-19.37|0.0080
70912812|NCT00991276|141316224|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.97|STANDARD_ERROR_OF_MEAN|2.85||0.0834|TWO_SIDED|95.0|-10.61|0.67||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage R sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.67|-10.61|0.0834
70912813|NCT00991276|141316224|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|18.59|STANDARD_ERROR_OF_MEAN|2.83|<|0.0001|TWO_SIDED|95.0|12.99|24.19||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage R sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||24.19|12.99|<0.0001
70912814|NCT00991276|141316224|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-23.56|STANDARD_ERROR_OF_MEAN|2.81|<|0.0001|TWO_SIDED|95.0|-29.12|-18.01||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage R sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-18.01|-29.12|<0.0001
70912815|NCT00991276|141316225|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.67|STANDARD_ERROR_OF_MEAN|0.99||0.0077|TWO_SIDED|95.0|-4.63|-0.72||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.72|-4.63|0.0077
70912816|NCT00991276|141316225|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.87|STANDARD_ERROR_OF_MEAN|0.98|<|0.0001|TWO_SIDED|95.0|-9.81|-5.93||This analysis was step 5 in a step-down procedure (if p-value \< 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-5.93|-9.81|<0.0001
71092757|NCT04530344|141691920|SUPERIORITY||Hazard Ratio (HR)|0.422||||0.0414|TWO_SIDED|95.0|0.18|0.99|||Log Rank|The p-value was based on the log-rank test stratified by randomization stratification factor between treatment and vehicle.||Cox regression model stratified by stratification factor (treatment assignment in the parent studies) was conducted to compare the difference in hazard rate between treatment and vehicle.||0.990|0.180|0.0414
70912817|NCT00991276|141316225|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.2|STANDARD_ERROR_OF_MEAN|0.97|<|0.0001|TWO_SIDED|95.0|3.27|7.12||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||7.12|3.27|<0.0001
70912818|NCT00991276|141316226|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.35|STANDARD_ERROR_OF_MEAN|2.57||0.0396|TWO_SIDED|95.0|-10.44|-0.26||This analysis was step 6 in a step-down procedure (if p-value \< 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.26|-10.44|0.0396
70912819|NCT00991276|141316226|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|2.55||0.0568|TWO_SIDED|95.0|-9.95|0.14||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.14|-9.95|0.0568
70912820|NCT00991276|141316226|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|2.52||0.8589|TWO_SIDED|95.0|-5.44|4.54||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||4.54|-5.44|0.8589
70912821|NCT00991276|141316227|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-14.5|STANDARD_ERROR_OF_MEAN|2.91|<|0.0001|TWO_SIDED|95.0|-20.26|-8.74||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-8.74|-20.26|<0.0001
70912822|NCT00991276|141316227|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.35|STANDARD_ERROR_OF_MEAN|2.88||0.0001|TWO_SIDED|95.0|5.65|17.04||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||17.04|5.65|0.0001
70912823|NCT00991276|141316227|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.84|STANDARD_ERROR_OF_MEAN|2.86|<|0.0001|TWO_SIDED|95.0|-31.51|-20.17||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-20.17|-31.51|<0.0001
70912824|NCT00991276|141316228|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-14.53|STANDARD_ERROR_OF_MEAN|3.19|<|0.0001|TWO_SIDED|95.0|-20.84|-8.22||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-8.22|-20.84|<0.0001
70912825|NCT00991276|141316228|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|14.42|STANDARD_ERROR_OF_MEAN|3.15|<|0.0001|TWO_SIDED|95.0|8.18|20.67||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||20.67|8.18|<0.0001
70970612|NCT00531752|141447058|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.0675|STANDARD_ERROR_OF_MEAN|2.9778||0.0949|TWO_SIDED|80.0|-8.934|-1.201|||Mixed Models Analysis|||Week 3 (IS-B/C): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.201|-8.934|0.0949
71092758|NCT04530344|141691921|SUPERIORITY||Hazard Ratio (HR)|0.316||||0.0003|TWO_SIDED|95.0|0.165|0.606|||Log Rank|The p-value was based on the log-rank test stratified by randomization stratification factor between treatment and vehicle.||Cox regression model stratified by stratification factor (treatment assignment in the parent studies) was conducted to compare the difference in hazard rate between treatment and vehicle.||0.606|0.165|0.0003
71153699|NCT00488683|141800055|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.04||||0.75||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup A||||0.75
70912826|NCT00991276|141316228|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.95|STANDARD_ERROR_OF_MEAN|3.14|<|0.0001|TWO_SIDED|95.0|-35.16|-22.74||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-22.74|-35.16|<0.0001
70912827|NCT00991276|141316229|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.86|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-3.93|-1.8||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.80|-3.93|<0.0001
70912828|NCT00991276|141316229|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.71|STANDARD_ERROR_OF_MEAN|0.53|<|0.0001|TWO_SIDED|95.0|-5.76|-3.65||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-3.65|-5.76|<0.0001
70912829|NCT00991276|141316229|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.84|STANDARD_ERROR_OF_MEAN|0.53||0.0007|TWO_SIDED|95.0|0.79|2.89||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||2.89|0.79|0.0007
70912830|NCT00991276|141316230|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.45|STANDARD_ERROR_OF_MEAN|1.3||0.0617|TWO_SIDED|95.0|-5.02|0.12||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.12|-5.02|0.0617
70912831|NCT00991276|141316230|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.35|STANDARD_ERROR_OF_MEAN|1.29|<|0.0001|TWO_SIDED|95.0|-8.91|-3.8||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-3.80|-8.91|<0.0001
71092759|NCT05523297|141691984|NON_INFERIORITY|The test for non-inferiority was one-sided Farrington-Manning score test with non-inferiority margin 10% at a significance level of 2.5%. If the 95% CI for treatment effect not only lay above -10% (the non-inferiority margin) but also above 0, then there was evidence of superiority.|percent difference|17.55|||<|0.0001|TWO_SIDED|95.0|8.7|26.4|||Two-sided Farrington-Manning score test.||Difference between Octaplex and FP arms for effectiveness|||26.4|8.7|<0.0001
71092760|NCT05523297|141691985|OTHER||Odds Ratio (OR)|1.91||||0.0022|TWO_SIDED|95.0|1.26|2.88|||Regression, Logistic|||||2.88|1.26|0.0022
71092761|NCT05523297|141691986|OTHER||Least Squares Mean Difference|-170.73|||<|0.0001|TWO_SIDED|95.0|-250.24|-91.22|||ANOVA|||12 hours after chest closure||-91.22|-250.24|<0.0001
71092762|NCT05523297|141691986|OTHER||Least Squares Mean Difference|-231.92|||<|0.0001|TWO_SIDED|95.0|-338.17|-125.67|||ANOVA|||24 hours after chest closure||-125.67|-338.17|<0.0001
71092763|NCT05523297|141691987|OTHER||Odds Ratio (OR)|3.19|||<|0.0001|TWO_SIDED|95.0|1.97|5.15|||Regression, Logistic|||Within 24 hours after IMP start||5.15|1.97|<0.0001
71153700|NCT00488683|141800055|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.11||||0.27||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup C||||0.27
71092764|NCT05523297|141691987|OTHER||Odds Ratio (OR)|2.88|||<|0.0001|TWO_SIDED|95.0|1.83|4.52|||Regression, Logistic|||Within 24 hours after surgery start||4.52|1.83|<0.0001
71092765|NCT05523297|141691987|OTHER||Odds Ratio (OR)|3.19|||<|0.0001|TWO_SIDED|95.0|1.97|5.15|||Regression, Logistic|||Within 24 hours after CPB end||5.15|1.97|<0.0001
71092766|NCT05523297|141691988|OTHER||Mean ratio|0.48|||<|0.0001|TWO_SIDED|95.0|0.41|0.57|||Counting regression|||||0.57|0.41|<0.0001
71092767|NCT05523297|141691989|OTHER||Mean ratio|0.71||||0.0015|TWO_SIDED|95.0|0.57|0.88|||Counting regression|||||0.88|0.57|0.0015
71092768|NCT05523297|141691990|OTHER||Mean ratio|0.61||||0.001|TWO_SIDED|95.0|0.46|0.82|||Counting regression|||During the first 24 hours after IMP start||0.82|0.46|0.0010
71092769|NCT05523297|141691990|OTHER||Mean ratio|0.59|||<|0.0001|TWO_SIDED|95.0|0.45|0.76|||Counting regression|||During the first 7 days after IMP start||0.76|0.45|<0.0001
71092770|NCT05523297|141691991|OTHER||Mean ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.03|0.06|||Negative binomial regression|||FP including IMP (During the first 24 hours after IMP start)||0.06|0.03|<0.0001
71092771|NCT05523297|141691991|OTHER||Mean ratio|0.85||||0.8522|TWO_SIDED|95.0|0.15|4.82|||Negative binomial regression|||FP excluding IMP (During the first 24 hours after IMP start)||4.82|0.15|0.8522
71092772|NCT05523297|141691991|OTHER||Mean ratio|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.68|||Negative binomial regression|||RBCs (During the first 24 hours after IMP start)||0.68|0.40|<0.0001
71092773|NCT05523297|141691991|OTHER||Mean ratio|0.65||||0.0169|TWO_SIDED|95.0|0.45|0.92|||Negative binomial regression|||Platelets (During the first 24 hours after IMP start)||0.92|0.45|0.0169
70912832|NCT00991276|141316230|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|1.28||0.0028|TWO_SIDED|95.0|1.37|6.44||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||6.44|1.37|0.0028
71153701|NCT00488683|141800055|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.2||||0.07||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||0.07
71153702|NCT00488683|141800055|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.23||||0.06||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||0.06
71153703|NCT00488683|141800055|SUPERIORITY_OR_OTHER||R-square|0.0029||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup A||||
71153704|NCT00488683|141800055|SUPERIORITY_OR_OTHER||R-square|0.0059||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup C||||
71153705|NCT00488683|141800055|SUPERIORITY_OR_OTHER||R-square|0.04||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||
71153706|NCT00488683|141800055|SUPERIORITY_OR_OTHER||R-square|0.21||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||
71153707|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.26||||0.46||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A||||0.46
71153708|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.14||||0.59||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A||||0.59
71153709|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.006||||0.98||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C||||0.98
71153710|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.24||||0.2||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C||||0.20
71153711|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.43||||0.08||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135||||0.08
71153712|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.08||||0.68||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135||||0.68
71153713|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.77||||0.006||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y||||0.006
71153714|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.16||||0.48||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y||||0.48
71153715|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.26||||0.46||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A||||0.46
71153716|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.21||||0.4||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A||||0.40
71153717|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.12||||0.6||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C||||0.60
71153718|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.4||||0.03||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C||||0.03
71153719|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.72||||0.001||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135||||0.001
71153720|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.0||||1||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135||||1.00
70912833|NCT00991276|141316231|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.24||0.0056|TWO_SIDED|95.0|-1.17|-0.21||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.21|-1.17|0.0056
70912834|NCT00991276|141316231|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.9|-0.95||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.95|-1.90|<0.0001
70912835|NCT00991276|141316231|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.74|STANDARD_ERROR_OF_MEAN|0.24||0.0026|TWO_SIDED|95.0|0.26|1.21||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.21|0.26|0.0026
70912836|NCT00991276|141316232|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|1.01|<|0.0001|TWO_SIDED|95.0|-8.1|-4.09||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-4.09|-8.10|<0.0001
70912837|NCT00991276|141316232|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.07|STANDARD_ERROR_OF_MEAN|1.01||0.0029|TWO_SIDED|95.0|-5.07|-1.07||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.07|-5.07|0.0029
70912838|NCT00991276|141316232|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.03|STANDARD_ERROR_OF_MEAN|1.01||0.0032|TWO_SIDED|95.0|-5.02|-1.04||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.04|-5.02|0.0032
70912839|NCT00991276|141316234|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|10.69|STANDARD_ERROR_OF_MEAN|7.71||0.1677|TWO_SIDED|95.0|-4.56|25.95||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||25.95|-4.56|0.1677
70912840|NCT00991276|141316234|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-35.77|STANDARD_ERROR_OF_MEAN|7.63|<|0.0001|TWO_SIDED|95.0|-50.88|-20.66||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-20.66|-50.88|<0.0001
70912841|NCT00991276|141316234|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|46.47|STANDARD_ERROR_OF_MEAN|7.59|<|0.0001|TWO_SIDED|95.0|31.45|61.48||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||61.48|31.45|<0.0001
70970613|NCT00531752|141447058|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.3274|STANDARD_ERROR_OF_MEAN|3.2552||0.0283|TWO_SIDED|80.0|-11.55|-3.106|||Mixed Models Analysis|||Week 3 (IS-B/C): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-3.106|-11.55|0.0283
71092774|NCT05523297|141691991|OTHER||Mean ratio|0.57||||0.3288|TWO_SIDED|95.0|0.18|1.76|||Negative binomial regression|||Cryoprecipitate (During the first 24 hours after IMP start)||1.76|0.18|0.3288
71092775|NCT05523297|141691991|OTHER||Mean ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.04|0.06|||Negative binomial regression|||FP including IMP (During the first 7 days after IMP start)||0.06|0.04|<0.0001
71092776|NCT05523297|141691991|OTHER||Mean ratio|0.63||||0.5439|TWO_SIDED|95.0|0.14|2.84|||Negative binomial regression|||FP excluding IMP (During the first 7 days after IMP start)||2.84|0.14|0.5439
71092777|NCT05523297|141691991|OTHER||Mean ratio|0.59|||<|0.0001|TWO_SIDED|95.0|0.47|0.74|||Negative binomial regression|||Red blood cells (During the first 7 days after IMP start)||0.74|0.47|<0.0001
71092778|NCT05523297|141691991|OTHER||Mean ratio|0.58||||0.0042|TWO_SIDED|95.0|0.4|0.84|||Negative binomial regression|||Platelets (During the first 7 days after IMP start)||0.84|0.40|0.0042
70912842|NCT00991276|141316235|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.73|STANDARD_ERROR_OF_MEAN|4.72||0.104|TWO_SIDED|95.0|-17.07|1.61||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.61|-17.07|0.1040
70912843|NCT00991276|141316235|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|4.68||0.9325|TWO_SIDED|95.0|-9.67|8.87||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||8.87|-9.67|0.9325
70912844|NCT00991276|141316235|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.33|STANDARD_ERROR_OF_MEAN|4.65||0.1175|TWO_SIDED|95.0|-16.54|1.87||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.87|-16.54|0.1175
70912845|NCT00991276|141316236|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-23.98|STANDARD_ERROR_OF_MEAN|4.45|<|0.0001|TWO_SIDED|95.0|-32.78|-15.18||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-15.18|-32.78|<0.0001
70912846|NCT00991276|141316236|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-24.74|STANDARD_ERROR_OF_MEAN|4.41|<|0.0001|TWO_SIDED|95.0|-33.46|-16.02||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-16.02|-33.46|<0.0001
70912847|NCT00991276|141316236|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.76|STANDARD_ERROR_OF_MEAN|4.38||0.8622|TWO_SIDED|95.0|-7.9|9.43||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||9.43|-7.90|0.8622
70912848|NCT00991276|141316237|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|1.87||0.08|TWO_SIDED|95.0|-7.0|0.4||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.40|-7.00|0.0800
70912849|NCT00991276|141316237|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.28|STANDARD_ERROR_OF_MEAN|1.86||0.2209|TWO_SIDED|95.0|-5.95|1.39||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.39|-5.95|0.2209
70912850|NCT00991276|141316237|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.02|STANDARD_ERROR_OF_MEAN|1.84||0.5815|TWO_SIDED|95.0|-4.66|2.63||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||2.63|-4.66|0.5815
70912851|NCT00991276|141316238|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|32.72|STANDARD_ERROR_OF_MEAN|5.41|<|0.0001|TWO_SIDED|95.0|22.02|43.42||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||43.42|22.02|<0.0001
70970614|NCT00531752|141447058|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1505|STANDARD_ERROR_OF_MEAN|1.5974||0.1852|TWO_SIDED|80.0|-4.229|-0.0719|||Mixed Models Analysis|||Week 3 (IS-I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.0719|-4.229|0.1852
71092779|NCT05523297|141691991|OTHER||Mean ratio|0.49||||0.2241|TWO_SIDED|95.0|0.15|1.56|||Negative binomial regression|||Cryoprecipitate (During the first 7 days after IMP start)||1.56|0.15|0.2241
71092780|NCT05523297|141691992|OTHER||Odds Ratio (OR)|0.9||||0.8364|TWO_SIDED|95.0|0.32|2.52|||Regression, Logistic|||FP excluding IMP (Within 24 hours after IMP start)||2.52|0.32|0.8364
70912852|NCT00991276|141316238|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|25.86|STANDARD_ERROR_OF_MEAN|5.37|<|0.0001|TWO_SIDED|95.0|15.22|36.49||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||36.49|15.22|<0.0001
70912853|NCT00991276|141316238|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.86|STANDARD_ERROR_OF_MEAN|5.33||0.2005|TWO_SIDED|95.0|-3.69|17.42||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||17.42|-3.69|0.2005
70912854|NCT00991276|141316239|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.8|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|4.57|9.02||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||9.02|4.57|<0.0001
70912855|NCT00991276|141316239|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.24|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|3.02|7.45||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||7.45|3.02|<0.0001
70912856|NCT00991276|141316239|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.56|STANDARD_ERROR_OF_MEAN|1.11||0.1622|TWO_SIDED|95.0|-0.64|3.75||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||3.75|-0.64|0.1622
70912857|NCT00991276|141316246|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.18|-0.47||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.47|-1.18|<0.0001
70912858|NCT00991276|141316246|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.31|-0.6||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.60|-1.31|<0.0001
70912859|NCT00991276|141316246|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.18||0.4677|TWO_SIDED|95.0|-0.22|0.48||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.48|-0.22|0.4677
70912860|NCT00991276|141316247|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.32|STANDARD_ERROR_OF_MEAN|5.31|<|0.0001|TWO_SIDED|95.0|-35.83|-14.8||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-14.80|-35.83|<0.0001
70912861|NCT00991276|141316247|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.45|STANDARD_ERROR_OF_MEAN|5.27|<|0.0001|TWO_SIDED|95.0|-38.89|-18.02||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-18.02|-38.89|<0.0001
70912862|NCT00991276|141316247|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.14|STANDARD_ERROR_OF_MEAN|5.19||0.5461|TWO_SIDED|95.0|-7.13|13.4||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||13.40|-7.13|0.5461
70912863|NCT00991276|141316248|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.04|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|0.63|1.45||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.45|0.63|<0.0001
70912864|NCT00991276|141316248|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.05|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|0.65|1.46||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.46|0.65|<0.0001
70912865|NCT00991276|141316248|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.2||0.9403|TWO_SIDED|95.0|-0.42|0.39||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.39|-0.42|0.9403
70912866|NCT00991276|141316249|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.58|STANDARD_ERROR_OF_MEAN|3.26||0.0215|TWO_SIDED|95.0|-14.03|-1.14||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.14|-14.03|0.0215
70912867|NCT00991276|141316249|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|3.23||0.5569|TWO_SIDED|95.0|-4.49|8.29||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||8.29|-4.49|0.5569
70912868|NCT00991276|141316249|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-9.48|STANDARD_ERROR_OF_MEAN|3.2||0.0036|TWO_SIDED|95.0|-15.81|-3.16||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-3.16|-15.81|0.0036
70912869|NCT00991276|141316250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.71|STANDARD_ERROR_OF_MEAN|1.8||0.6947|TWO_SIDED|95.0|-2.85|4.27||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Awaken Short of Breath/with Headache: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||4.27|-2.85|0.6947
70912870|NCT00991276|141316250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.52|STANDARD_ERROR_OF_MEAN|1.79||0.398|TWO_SIDED|95.0|-5.06|2.02||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Awaken Short of Breath/with Headache: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||2.02|-5.06|0.3980
70912871|NCT00991276|141316250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.23|STANDARD_ERROR_OF_MEAN|1.78||0.2144|TWO_SIDED|95.0|-1.3|5.76||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Awaken Short of Breath/with Headache: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||5.76|-1.30|0.2144
71092781|NCT05523297|141691992|OTHER||Odds Ratio (OR)|2.11||||0.0002|TWO_SIDED|95.0|1.42|3.11|||Regression, Logistic|||RBCs (Within 24 hours after IMP start)||3.11|1.42|0.0002
71092782|NCT05523297|141691992|OTHER||Odds Ratio (OR)|1.31||||0.1742|TWO_SIDED|95.0|0.89|1.91|||Regression, Logistic|||Platelets (Within 24 hours after IMP start)||1.91|0.89|0.1742
71092783|NCT05523297|141691992|OTHER||Odds Ratio (OR)|1.4||||0.4618|TWO_SIDED|95.0|0.58|3.38|||Regression, Logistic|||Cryoprecipitate (Within 24 hours after IMP start)||3.38|0.58|0.4618
71092784|NCT05523297|141691992|OTHER||Odds Ratio (OR)|1.69||||0.0129|TWO_SIDED|95.0|1.12|2.55|||Regression, Logistic|||Any individual ABP (Within 24 hours after IMP start)||2.55|1.12|0.0129
71092785|NCT05523297|141691992|OTHER||Odds Ratio (OR)|1.58||||0.3297|TWO_SIDED|95.0|0.63|3.94|||Regression, Logistic|||FP excluding IMP (Within 7 days after IMP start)||3.94|0.63|0.3297
71092786|NCT05523297|141691992|OTHER||Odds Ratio (OR)|1.82||||0.0049|TWO_SIDED|95.0|1.2|2.76|||Regression, Logistic|||RBCs (Within 7 days after IMP start)||2.76|1.20|0.0049
71092787|NCT05523297|141691992|OTHER||Odds Ratio (OR)|1.26||||0.2417|TWO_SIDED|95.0|0.86|1.84|||Regression, Logistic|||Platelets (Within 7 days after IMP start)||1.84|0.86|0.2417
70912872|NCT00991276|141316250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|14.17|STANDARD_ERROR_OF_MEAN|4.0||0.0006|TWO_SIDED|95.0|6.25|22.08||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Adequacy: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||22.08|6.25|0.0006
70912873|NCT00991276|141316250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.07|STANDARD_ERROR_OF_MEAN|3.97||0.0061|TWO_SIDED|95.0|3.22|18.92||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Adequacy: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||18.92|3.22|0.0061
70970615|NCT00531752|141447058|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5178|STANDARD_ERROR_OF_MEAN|1.7732||0.1623|TWO_SIDED|80.0|-4.823|-0.2127|||Mixed Models Analysis|||Week 3 (IS-I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.2127|-4.823|0.1623
71092788|NCT05523297|141691992|OTHER||Odds Ratio (OR)|1.4||||0.4618|TWO_SIDED|95.0|0.58|3.38|||Regression, Logistic|||Cryoprecipitate (Within 7 days after IMP start)||3.38|0.58|0.4618
71092789|NCT05523297|141691992|OTHER||Odds Ratio (OR)|1.56||||0.0564|TWO_SIDED|95.0|0.99|2.47|||Regression, Logistic|||Any individual ABP (Within 7 days after IMP start)||2.47|0.99|0.0564
71092790|NCT05523297|141691993|OTHER||Odds Ratio (OR)|1.1||||0.6956|TWO_SIDED|95.0|0.69|1.73|||Regression, Logistic|||Fibrinogen concentrate (Within 24 hours after IMP start)||1.73|0.69|0.6956
71153721|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.39||||0.24||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y||||0.24
71153722|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.22||||0.34||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for the analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y||||0.34
71153723|NCT00488683|141800056|SUPERIORITY_OR_OTHER||R-square|0.07||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A||||
71153724|NCT00488683|141800056|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A||||
71153725|NCT00488683|141800056|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C||||
71153726|NCT00488683|141800056|SUPERIORITY_OR_OTHER||R-square|0.06||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C||||
71092791|NCT05523297|141691993|OTHER||Odds Ratio (OR)|5.337||||0.0317|TWO_SIDED|95.0|1.12|50.7|||Regression, Logistic|||||50.70|1.12|0.0317
71092792|NCT05523297|141691993|OTHER||Odds Ratio (OR)|18.88|||<|0.0001|TWO_SIDED|95.0|2.9|796.37|||Regression, Logistic|||PCC excluding IMP (Within 24 hours after IMP start)||796.37|2.90|<0.0001
71092793|NCT05523297|141691993|OTHER||Odds Ratio (OR)|1.334||||0.1981|TWO_SIDED|95.0|0.86|2.07|||Regression, Logistic|||Any coagulation factor product (Within 24 hours after IMP start)||2.07|0.86|0.1981
71092794|NCT05523297|141691993|OTHER||Odds Ratio (OR)|1.187||||0.4599|TWO_SIDED|95.0|0.75|1.87|||Regression, Logistic|||Fibrinogen concentrate (Within 7 days after IMP start)||1.87|0.75|0.4599
71092795|NCT05523297|141691993|OTHER||Odds Ratio (OR)|5.337||||0.0317|TWO_SIDED|95.0|1.12|50.7|||Regression, Logistic|||rFVIIa (Within 7 days after IMP start)||50.70|1.12|0.0317
71092796|NCT05523297|141691993|OTHER||Odds Ratio (OR)|18.88|||<|0.0001|TWO_SIDED|95.0|2.9|796.37|||Regression, Logistic|||PCC excluding IMP (Within 7 days after IMP start)||796.37|2.90|<0.0001
71092797|NCT05523297|141691993|OTHER||Odds Ratio (OR)|1.431||||0.1073|TWO_SIDED|95.0|0.93|2.21|||Regression, Logistic|||Any coagulation factor product (Within 7 days after IMP start)||2.21|0.93|0.1073
71092798|NCT05523297|141691996|OTHER||Odds Ratio (OR)|1.435||||0.3782|TWO_SIDED|95.0|0.6429|3.2013|||Regression, Logistic|||Within 24 hours after CPB end||3.2013|0.6429|0.3782
71092799|NCT05523297|141691996|OTHER||Odds Ratio (OR)|1.435||||0.3782|TWO_SIDED|95.0|0.6429|3.2013|||Regression, Logistic|||Within 24 hours after IMP start||3.2013|0.6429|0.3782
71092800|NCT05523297|141691996|OTHER||Odds Ratio (OR)|1.332||||0.4899|TWO_SIDED|95.0|0.5902|3.0062|||Regression, Logistic|||Within 24 hours after surgery start||3.0062|0.5902|0.4899
71092801|NCT05523297|141691997|OTHER||Least Squares Mean Difference|-0.15||||0.0081|TWO_SIDED|95.0|-0.26|-0.04|||ANOVA|||||-0.04|-0.26|0.0081
71092802|NCT05523297|141691998|OTHER||Least Squares Mean Difference|-9.63||||0.6735|TWO_SIDED|95.0|-60.45|41.18|||ANOVA|||||41.18|-60.45|0.6735
71153727|NCT00488683|141800056|SUPERIORITY_OR_OTHER||R-square|0.19||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135||||
71153728|NCT00488683|141800056|SUPERIORITY_OR_OTHER||R-square|0.007||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135||||
71153729|NCT00488683|141800056|SUPERIORITY_OR_OTHER||R-square|0.59||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y||||
70912874|NCT00991276|141316250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|3.95||0.4342|TWO_SIDED|95.0|-4.72|10.93||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Adequacy: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||10.93|-4.72|0.4342
70912875|NCT00991276|141316250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.43|STANDARD_ERROR_OF_MEAN|2.07||0.242|TWO_SIDED|95.0|-6.53|1.66||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Somnolence: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.66|-6.53|0.2420
70912876|NCT00991276|141316250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|2.05||0.981|TWO_SIDED|95.0|-4.12|4.02||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Somnolence: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||4.02|-4.12|0.9810
70912877|NCT00991276|141316250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.38|STANDARD_ERROR_OF_MEAN|2.05||0.2468|TWO_SIDED|95.0|-6.44|1.67||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Somnolence: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.67|-6.44|0.2468
70912878|NCT00991276|141316250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.32||0.1496|TWO_SIDED|95.0|-0.17|1.09||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Quantity: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.09|-0.17|0.1496
70912879|NCT00991276|141316250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.31||0.8184|TWO_SIDED|95.0|-0.69|0.55||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Quantity: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.55|-0.69|0.8184
70912880|NCT00991276|141316250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.31||0.0918|TWO_SIDED|95.0|-0.09|1.15||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Quantity: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.15|-0.09|0.0918
70912881|NCT00991276|141316250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-9.89|STANDARD_ERROR_OF_MEAN|2.48||0.0001|TWO_SIDED|95.0|-14.8|-4.99||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||6-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-4.99|-14.80|0.0001
70912882|NCT00991276|141316250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.54|STANDARD_ERROR_OF_MEAN|2.46||0.0089|TWO_SIDED|95.0|-11.42|-1.67||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||6-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.67|-11.42|0.0089
70912883|NCT00991276|141316250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.35|STANDARD_ERROR_OF_MEAN|2.45||0.1746|TWO_SIDED|95.0|-8.21|1.51||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||6-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.51|-8.21|0.1746
70970616|NCT00531752|141447059|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.5791|STANDARD_ERROR_OF_MEAN|18.0449||0.5241|TWO_SIDED|80.0|-35.02|11.86|||Mixed Models Analysis|||Week 3 (Life productivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||11.860|-35.02|0.5241
71092803|NCT05523297|141691999|OTHER||Least Squares Mean Difference|-17.93||||0.9033|TWO_SIDED|95.0|-450.13|414.28|||ANOVA|||||414.28|-450.13|0.9033
71092804|NCT05523297|141692000|OTHER||Least Squares Mean Difference|-0.41||||0.1808|TWO_SIDED|95.0|-1.1|0.29|||ANOVA|||||0.29|-1.10|0.1808
70912884|NCT00991276|141316250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-10.14|STANDARD_ERROR_OF_MEAN|2.44|<|0.0001|TWO_SIDED|95.0|-14.96|-5.32||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||9-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-5.32|-14.96|<0.0001
70912885|NCT00991276|141316250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.13|STANDARD_ERROR_OF_MEAN|2.42||0.0359|TWO_SIDED|95.0|-9.91|-0.34||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||9-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.34|-9.91|0.0359
70912886|NCT00991276|141316250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.01|STANDARD_ERROR_OF_MEAN|2.41||0.0395|TWO_SIDED|95.0|-9.78|-0.24||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||9-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.24|-9.78|0.0395
70912887|NCT00991276|141316250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.06||0.0278|TWO_SIDED|95.0|0.02|0.27||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Optimal Sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.27|0.02|0.0278
70912888|NCT00991276|141316250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.06||0.2||95.0|-0.04|0.2||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Optimal Sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.20|-0.04|0.2000
70912889|NCT00991276|141316250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.06||0.3396|TWO_SIDED|95.0|-0.06|0.18||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Optimal Sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.18|-0.06|0.3396
70912890|NCT00991276|141316250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-14.56|STANDARD_ERROR_OF_MEAN|3.22|<|0.0001|TWO_SIDED|95.0|-20.93|-8.19||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Disturbance: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-8.19|-20.93|<0.0001
70912891|NCT00991276|141316250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.11|STANDARD_ERROR_OF_MEAN|3.2||0.0584|TWO_SIDED|95.0|-12.43|0.22||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Disturbance: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.22|-12.43|0.0584
70912892|NCT00991276|141316250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-8.45|STANDARD_ERROR_OF_MEAN|3.19||0.009|TWO_SIDED|95.0|-14.76|-2.15||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Disturbance: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-2.15|-14.76|0.0090
70912893|NCT00991276|141316250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.69|STANDARD_ERROR_OF_MEAN|2.28||0.2405|TWO_SIDED|95.0|-7.2|1.82||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Snoring: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.82|-7.20|0.2405
71092805|NCT05523297|141692001|OTHER||Least Squares Mean Difference|0.28||||0.9698|TWO_SIDED|95.0|-14.78|15.34|||ANOVA|||||15.34|-14.78|0.9698
71092806|NCT05523297|141692002|OTHER||Least Squares Mean Difference|-3.1||||0.3363|TWO_SIDED|95.0|-9.61|3.42|||ANOVA|||||3.42|-9.61|0.3363
71092807|NCT05523297|141692003|OTHER||Least Squares Mean Difference|2.42||||0.5736|TWO_SIDED|95.0|-6.33|11.16|||ANOVA|||||11.16|-6.33|0.5736
71092808|NCT05523297|141692004|OTHER||Least Squares Mean Difference|-13.19||||0.2667|TWO_SIDED|95.0|-37.05|10.67|||ANOVA|||||10.67|-37.05|0.2667
71092809|NCT05523297|141692005|OTHER||Least Squares Mean Difference|12.25||||0.0658|TWO_SIDED|95.0|-0.87|25.38|||ANOVA|||||25.38|-0.87|0.0658
70912894|NCT00991276|141316250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.26||0.7565|TWO_SIDED|95.0|-5.18|3.77||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Snoring: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||3.77|-5.18|0.7565
70912895|NCT00991276|141316250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.98|STANDARD_ERROR_OF_MEAN|2.25||0.3792|TWO_SIDED|95.0|-6.43|2.47||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Snoring: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||2.47|-6.43|0.3792
70912896|NCT00991276|141316251|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.27|STANDARD_ERROR_OF_MEAN|1.66||0.0019|TWO_SIDED|95.0|1.98|8.55||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||8.55|1.98|0.0019
70912897|NCT00991276|141316251|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.25|STANDARD_ERROR_OF_MEAN|1.65||0.0506|TWO_SIDED|95.0|-0.01|6.51||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||6.51|-0.01|0.0506
70912898|NCT00991276|141316251|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.01|STANDARD_ERROR_OF_MEAN|1.64||0.2222|TWO_SIDED|95.0|-1.24|5.26||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||5.26|-1.24|0.2222
70912899|NCT01720043|141316254|SUPERIORITY|||||||0.181|||||||t-test, 2 sided|||Collagen.5.g.ml, 24 hrs||||0.181
70912900|NCT01720043|141316254|SUPERIORITY|||||||0.164|||||||t-test, 2 sided|||Collagen.2.g.ml||||.164
70912901|NCT01720043|141316254|SUPERIORITY|||||||0.132|||||||t-test, 2 sided|||ADP.10.M, 24 hrs||||.132
70912902|NCT01720043|141316254|SUPERIORITY|||||||0.066|||||||t-test, 2 sided|||ADP.5.M||||.066
70912903|NCT01720043|141316254|SUPERIORITY|||||||0.268|||||||t-test, 2 sided|||ADP.3.M, 24 hrs||||0.268
70912904|NCT01720043|141316254|SUPERIORITY|||||||0.106|||||||t-test, 2 sided|||Arach.Acid.0.5.mg.ml||||0.106
70912905|NCT01720043|141316254|SUPERIORITY|||||||0.625|||||||t-test, 2 sided|||Ristocetin.1.5.mg.ml||||0.625
70912906|NCT01720043|141316254|SUPERIORITY|||||||0.381|||||||t-test, 2 sided|||Ristocetin.0.5.mg.ml||||0.381
70912907|NCT01720043|141316254|SUPERIORITY|||||||0.549|||||||t-test, 2 sided|||Collagen.5.g.ml, 48 hrs||||0.549
70912908|NCT01720043|141316254|SUPERIORITY|||||||0.838|||||||t-test, 2 sided|||Collagen.2.g.ml, 48 hrs||||.838
70912909|NCT01720043|141316254|SUPERIORITY|||||||0.245|||||||t-test, 2 sided|||ADP.10.M||||0.245
70912910|NCT01720043|141316254|SUPERIORITY|||||||0.417|||||||t-test, 2 sided|||ADP.5.M||||0.417
70912911|NCT01720043|141316254|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||ADP.3.M, 48 hrs||||0.770
70912912|NCT01720043|141316254|SUPERIORITY|||||||0.614|||||||t-test, 2 sided|||Arach.Acid.0.5.mg.ml, 48 hrs||||0.614
70912913|NCT01720043|141316254|SUPERIORITY|||||||0.969|||||||t-test, 2 sided|||Ristochetin.1.5.mg.ml||||0.969
70912914|NCT01720043|141316254|SUPERIORITY|||||||0.238|||||||t-test, 2 sided|||Ristocetin.0.5.mg.ml, 48 hrs||||0.238
70912915|NCT02022462|141316260|SUPERIORITY|||||||0.073|||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change of z-scores.||||.073
70912916|NCT02022462|141316260|SUPERIORITY||Mean Difference (Net)|0.19|STANDARD_DEVIATION|0.91||0.066|TWO_SIDED||||||t-test, 2 sided|||Within-group mean z-score change from 6 months to 12-months (post-intervention) for the immediate treatment group only.||||.066
70912917|NCT02022462|141316261|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.983|TWO_SIDED||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.983
70912918|NCT02022462|141316261|SUPERIORITY||Mean Difference (Net)|0.17|STANDARD_DEVIATION|1.95||0.533|TWO_SIDED||||||t-test, 2 sided|||Within-group mean change from 6 months to 12-months (post-intervention) for the immediate treatment group only.||||.533
70912919|NCT02022462|141316262|SUPERIORITY|||||||0.731|||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.731
71092810|NCT05523297|141692006|OTHER||Least Squares Mean Difference|-0.19||||0.0726|TWO_SIDED|95.0|-0.4|0.02|||ANOVA|||||0.02|-0.40|0.0726
70912920|NCT02022462|141316262|SUPERIORITY||Mean Difference (Final Values)|0.29|STANDARD_DEVIATION|1.67||0.211|TWO_SIDED||||||t-test, 2 sided|||Within-group mean change from 6 months to 12-months (post-intervention) for the immediate treatment group only.||||.211
70912921|NCT02022462|141316263|SUPERIORITY||Mean Difference (Net)|0.04||||0.244|TWO_SIDED||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.244
70912922|NCT02022462|141316263|SUPERIORITY||Mean Difference (Net)|0.13|STANDARD_DEVIATION|0.35||0.016|TWO_SIDED||||||t-test, 2 sided|||||||.016
71092811|NCT05523297|141692011|OTHER||Odds Ratio (OR)|1.183||||0.7497|TWO_SIDED|95.0|0.4211|3.3235|||Regression, Logistic|||||3.3235|0.4211|0.7497
71092812|NCT04133909|141692068|SUPERIORITY||Rate ratio (Mepolizumab 100 mg/Placebo)|0.79||||0.011|TWO_SIDED|95.0|0.66|0.94|||Negative binomial model|||Analysis performed using a negative binomial model with covariates of treatment group, geographic region, number of moderate/severe exacerbations in previous year (less than or equal to \[\<=\]2, 3, \>=4 as ordinal), baseline percent (%) predicted Forced expiratory volume in one second (FEV1) and smoking status (current vs. former smoker), and with logarithm (time on- and off-treatment) as an offset variable.||0.94|0.66|0.011
70912923|NCT02022462|141316264|SUPERIORITY||Mean Difference (Net)|0.4||||0.019|TWO_SIDED||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.019
70912924|NCT02022462|141316264|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.66||0.609|TWO_SIDED||||||t-test, 2 sided|||||||.609
70912925|NCT02022462|141316265|SUPERIORITY|||||||0.203|||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.203
70912926|NCT02022462|141316265|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_DEVIATION|0.59||0.48|TWO_SIDED||||||t-test, 2 sided|||||||.480
70912927|NCT02022462|141316266|SUPERIORITY||Mean Difference (Net)|0.01||||0.897|TWO_SIDED||||||t-test, 2 sided|||||||.897
70912928|NCT02022462|141316266|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.48||0.903|TWO_SIDED||||||t-test, 2 sided|||||||.903
70912929|NCT02022462|141316267|SUPERIORITY||Mean Difference (Net)|-0.787||||0.433|TWO_SIDED||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.433
70912930|NCT02022462|141316267|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.52||0.936|TWO_SIDED||||||t-test, 2 sided|||||||.936
70912931|NCT02022462|141316268|SUPERIORITY|||||||0.228|||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change in z-scores of diet.||||.228
70912932|NCT02022462|141316268|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_DEVIATION|1.03||0.617|TWO_SIDED||||||t-test, 2 sided|||||||.617
70912933|NCT02022462|141316269|SUPERIORITY||Mean Difference (Net)|0.01||||0.894|TWO_SIDED||||||t-test, 2 sided|||||||.894
70912934|NCT02022462|141316269|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.46||0.93|TWO_SIDED||||||t-test, 2 sided|||||||.930
70912935|NCT02022462|141316270|SUPERIORITY||Mean Difference (Net)|0.15||||0.53|TWO_SIDED||||||t-test, 2 sided|||||||.530
71092813|NCT04133909|141692069|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.009|TWO_SIDED|95.0|0.64|0.93|||Cox Proportional Hazards Model|||Estimated from a Cox Proportional Hazards Model with covariates of treatment group, geographic region, number of moderate or severe exacerbations in previous year \<=2, 3, \>=4 as ordinal), baseline % predicted FEV1 and smoking status (current vs former).||0.93|0.64|0.009
70912936|NCT02022462|141316270|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_DEVIATION|1.27||0.458|TWO_SIDED||||||t-test, 2 sided|||||||.458
70912937|NCT02022462|141316271|SUPERIORITY||Mean Difference (Net)|0.31||||0.036|TWO_SIDED||||||t-test, 2 sided|||||||.036
70912938|NCT02022462|141316271|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_DEVIATION|1.0||0.892|TWO_SIDED||||||t-test, 2 sided|||||||.892
70912939|NCT02022462|141316272|SUPERIORITY||Mean Difference (Net)|0.41||||0.931|TWO_SIDED||||||t-test, 2 sided|||||||.931
70912940|NCT02022462|141316272|SUPERIORITY||Mean Difference (Net)|-6.43|STANDARD_DEVIATION|24.34||0.058|TWO_SIDED||||||t-test, 2 sided|||||||.058
70912941|NCT02022462|141316273|SUPERIORITY||Mean Difference (Net)|0.4||||0.576|TWO_SIDED||||||t-test, 2 sided|||||||.576
70912942|NCT02022462|141316273|SUPERIORITY||Mean Difference (Net)|-1.06|STANDARD_DEVIATION|33.89||0.829|TWO_SIDED||||||t-test, 2 sided|||||||.829
71092814|NCT04133909|141692070|SUPERIORITY||Odds Ratio (OR)|0.81||||0.161|TWO_SIDED|95.0|0.6|1.09|||Regression, Logistic|||A logistic regression model was used to compare the proportion of responders between the mepolizumab and placebo arms in the mITT and mITT2 populations. The model includes fixed categorical covariates (treatment group, smoking status, geographic region) and a fixed continuous covariate (baseline score).||1.09|0.60|0.161
70912943|NCT02022462|141316274|SUPERIORITY|||||||0.792|||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.792
70912944|NCT02022462|141316274|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_DEVIATION|0.55||0.622|TWO_SIDED||||||t-test, 2 sided|||||||.622
70912945|NCT02022462|141316275|SUPERIORITY||Mean Difference (Net)|1.986||||0.049|TWO_SIDED||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.049
70912946|NCT02022462|141316275|SUPERIORITY||Mean Difference (Net)|0.29|STANDARD_DEVIATION|1.67||0.211|TWO_SIDED||||||t-test, 2 sided|||||||.211
70912947|NCT02796092|141316284|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Assuming that both methods were equally effective, we did not use this primary outcome to calculate sample size. It was determined using our own retrospective data of patients from the year 2013, comparing the means of the procedure total time with both methods (41.20±4.66 vs 34.99±4.43 minutes). Ten patients in each group were considered enough to detect the above-mentioned differences with a α-error of 0.05 and 80% power, using a two-sided test.||||>0.999
70912948|NCT02796092|141316285|SUPERIORITY_OR_OTHER|||||||0.3|||||||Fisher Exact|||||||0.3
70912949|NCT02796092|141316286|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
70912950|NCT02796092|141316287|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
70912951|NCT02796092|141316288|SUPERIORITY_OR_OTHER|||||||0.061|||||||Wilcoxon (Mann-Whitney)|||||||0.061
70912952|NCT02796092|141316289|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70912953|NCT02796092|141316290|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70912954|NCT02796092|141316291|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70912955|NCT02796092|141316292|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70912956|NCT02796092|141316293|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70912957|NCT02796092|141316294|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70912958|NCT02796092|141316295|SUPERIORITY_OR_OTHER|||||||0.0499|||||||Chi-squared|||||||0.0499
70912959|NCT02796092|141316297|SUPERIORITY_OR_OTHER|||||||0.095|||||||Fisher Exact|||||||0.095
70912960|NCT02534896|141316298|SUPERIORITY|||||||0.018|||||||Hochberg and Gatekeeping|||||||0.018
70912961|NCT02534896|141316298|SUPERIORITY|||||||0.007|||||||Hochberg and Gatekeeping|||||||0.007
70912962|NCT02534896|141316299|SUPERIORITY|||||||0.028|||||||Hochberg and Gatekeeping|||||||0.028
70912963|NCT02534896|141316299|SUPERIORITY|||||||0.003|||||||Hochberg and Gatekeeping|||||||0.003
70912964|NCT02534896|141316300|SUPERIORITY|||||||0.96|||||||Hochberg and Gatekeeping|||||||0.960
70912965|NCT02534896|141316300|SUPERIORITY|||||||0.339|||||||Hochberg and Gatekeeping|||||||0.339
70912966|NCT02534896|141316301|SUPERIORITY|||||||0.573|||||||Hochberg and Gatekeeping|||||||0.573
70912967|NCT02534896|141316301|SUPERIORITY|||||||0.374|||||||Hochberg and Gatekeeping|||||||0.374
70912968|NCT01107626|141316302|SUPERIORITY|||||||0.12|||||||Log Rank|Stratified logrank test||||||0.12
70912969|NCT01107626|141316302|SUPERIORITY|||||||0.28|||||||Log Rank|Stratified logrank test||||||0.28
70912970|NCT00711646|141316310|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.517||||0.048|TWO_SIDED|95.0|-1.029|-0.004|||ANCOVA|||The change in mean 11-point Numerical Rating Scale spasticity score was compared between treatment groups using analysis of covariance (ANCOVA). The model included treatment and centre as factors and baseline 11-point Numerical Rating Scale spasticity score as a covariate.||-0.004|-1.029|0.048
70912971|NCT00711646|141316311|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.11||||0.218|TWO_SIDED|95.0|-0.29|0.07|||ANCOVA|||The change in mean Ashworth Scale score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Ashworth Scale score as a covariate.||0.07|-0.29|0.218
70912972|NCT00711646|141316312|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.17||||0.141|TWO_SIDED|95.0|-0.39|0.06|||ANCOVA|||The change in mean spasm frequency score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline spasm frequency score as a covariate.||0.06|-0.39|0.141
70912973|NCT00711646|141316313|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|1.3||||0.766|TWO_SIDED|95.0|-7.47|10.07|||ANCOVA|||The change in mean Motricity Index score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Motricity Index score as a covariate.||10.07|-7.47|0.766
70912974|NCT00711646|141316314|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|8.46||||0.349|TWO_SIDED|95.0|-6.74|23.66|||Fisher Exact|||The proportion of subjects who considered their condition 'Very Much Improved', 'Much Improved' or 'Minimally Improved' was compared between treatment groups using Fisher's Exact Test.||23.66|-6.74|0.349
70912975|NCT00711646|141316316|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|3.86||||0.054|TWO_SIDED|95.0|-0.06|7.78|||ANCOVA|||The change in mean Motricity Index score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Motricity Index score as a covariate.||7.78|-0.06|0.054
70912976|NCT04310579|141316330|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.22|ONE_SIDED|95.0||2.5||To demonstrate an effect of oxycodone with midazolam compared to oxycodone alone, it is necessary that the upper bound of the one-sided 95% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone with midazolam compared to oxycodone alone.|Part 1 is powered with consideration to both the effect of oxycodone versus placebo and oxycodone plus midazolam versus oxycodone. Assuming a -4 L/min effect size on VE55 and standard deviation of 5 L/min, there is greater than 90% power at a one-sided 0.05 significance level for a sample size of 20 subjects.||2.5||0.22
70912977|NCT04310579|141316331|SUPERIORITY||Mean Difference (Final Values)|-4.9||||0.01|ONE_SIDED|97.5||-0.6||To demonstrate an effect of oxycodone with paroxetine compared to oxycodone alone, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Sample size and power were calculated based on 2 primary outcomes (day 1 and day 5) with adjustment for multiplicity (α=.025). The assessments with paroxetine or quetiapine were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-0.6||0.01
70912978|NCT04310579|141316331|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.28|ONE_SIDED|97.5||2.8||To demonstrate an effect of oxycodone with quetiapine compared to oxycodone alone, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and quetiapine compared to oxycodone and placebo.|Sample size and power were calculated based on 2 primary outcomes (day 1 and day 5) with adjustment for multiplicity (α=.025). The assessments with paroxetine or quetiapine were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||2.8||0.28
70912979|NCT04310579|141316332|SUPERIORITY||Mean Difference (Final Values)|-10.2|||<|0.001|ONE_SIDED|97.5||-6.3||To demonstrate an effect of oxycodone with paroxetine compared to oxycodone alone, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Sample size and power were calculated based on 2 primary outcomes (day 1 and day 5) with adjustment for multiplicity (α=.025). The assessments with paroxetine or quetiapine were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-6.3||<0.001
71092815|NCT04133909|141692071|SUPERIORITY||Odds Ratio (OR)|1.17||||0.291|TWO_SIDED|95.0|0.87|1.57|||Regression, Logistic|||A logistic regression model was used to compare the proportion of responders between the mepolizumab and placebo arms in the mITT and mITT2 populations. The model includes fixed categorical covariates (treatment group, smoking status, geographic region) and a fixed continuous covariate (baseline score).||1.57|0.87|0.291
71153730|NCT00488683|141800056|SUPERIORITY_OR_OTHER||R-square|0.03||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y||||
70912980|NCT04310579|141316332|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.37|ONE_SIDED|97.5||3.2||To demonstrate an effect of oxycodone with quetiapine compared to oxycodone alone, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and quetiapine compared to oxycodone and placebo.|Sample size and power were calculated based on 2 primary outcomes (day 1 and day 5) with adjustment for multiplicity (α=.025). The assessments with paroxetine or quetiapine were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||3.2||0.37
70912981|NCT04310579|141316333|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.005|ONE_SIDED|95.0||-2.5||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of oxycodone compared to placebo, it is necessary that the upper bound of the one-sided 95% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone compared to placebo.|Part 1 is powered with consideration to both the effect of oxycodone versus placebo and oxycodone plus midazolam versus oxycodone. Assuming a -4 L/min effect size on VE55 and standard deviation of 5 L/min, there is greater than 90% power at a one-sided 0.05 significance level for a sample size of 20 subjects.||-2.5||0.005
70912982|NCT04310579|141316333|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.37|ONE_SIDED|95.0||3.7||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of midazolam compared to placebo, it is necessary that the upper bound of the one-sided 95% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of midazolam compared to placebo.|Part 1 is powered with consideration to both the effect of oxycodone versus placebo and oxycodone plus midazolam versus oxycodone. Assuming a -4 L/min effect size on VE55 and standard deviation of 5 L/min, there is greater than 90% power at a one-sided 0.05 significance level for a sample size of 20 subjects.||3.7||0.37
70912983|NCT04310579|141316334|SUPERIORITY||Mean Difference (Final Values)|-9.3|||<|0.001|ONE_SIDED|97.5||-3.9||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of paroxetine compared to placebo, it is necessary that the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of paroxetine compared to placebo.|Sample size and power were calculated based on 2 primary outcomes (day 1 and day 5) with adjustment for multiplicity (α=.025). The assessments with paroxetine or quetiapine were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-3.9||<0.001
70912984|NCT04310579|141316334|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.67|ONE_SIDED|97.5||6.4||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of quetiapine compared to placebo, it is necessary that the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of quetiapine compared to placebo.|Sample size and power were calculated based on 2 primary outcomes (day 1 and day 5) with adjustment for multiplicity (α=.025). The assessments with paroxetine or quetiapine were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||6.4||0.67
70912985|NCT04310579|141316336|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.06||||0.33|TWO_SIDED|90.0|0.96|1.17||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Maximum oxycodone concentration was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 1 with treatment as a categorical variable and participant as a random effect||1.17|0.96|0.33
70912986|NCT04310579|141316336|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.25|||<|0.001|TWO_SIDED|90.0|1.14|1.37||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and quetiapine compared to oxycodone and placebo.|Maximum oxycodone concentration was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 1 with treatment as a categorical variable and participant as a random effect||1.37|1.14|<0.001
70912987|NCT04310579|141316337|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.3|||<|0.001|TWO_SIDED|90.0|1.19|1.43||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Maximum oxycodone concentration was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 5 with treatment as a categorical variable and participant as a random effect||1.43|1.19|<0.001
70912988|NCT04310579|141316337|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.39|||<|0.001|TWO_SIDED|90.0|1.22|1.57||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and quetiapine compared to oxycodone and placebo.|Maximum oxycodone concentration was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 5 with treatment as a categorical variable and participant as a random effect||1.57|1.22|<0.001
71153731|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.77||||0.0002||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A||||0.0002
71153732|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.03||||0.9||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A||||0.90
71153733|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.47||||0.02||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C||||0.02
71153734|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.29||||0.12||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C||||0.12
71153735|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.31||||0.22||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135||||0.22
71153736|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.81|||<|0.0001||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135||||<0.0001
71153737|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.15||||0.82||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y||||0.82
71153738|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.15||||0.66||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y||||0.66
71153739|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.51||||0.03||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A||||0.03
71153740|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.14||||0.53||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A||||0.53
71153741|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.2||||0.35||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C||||0.35
71153742|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.47||||0.09||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C||||0.09
71153743|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.51||||0.04||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135||||0.04
71153744|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.35||||0.1||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135||||0.10
71153745|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.35||||0.56||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y||||0.56
71153746|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.07||||0.84||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y||||0.84
71153747|NCT00488683|141800056|SUPERIORITY_OR_OTHER||R-square|0.59||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A||||
71153748|NCT00488683|141800056|SUPERIORITY_OR_OTHER||R-square|0.001||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A||||
71153749|NCT00488683|141800056|SUPERIORITY_OR_OTHER||R-square|0.22||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C||||
71153750|NCT00488683|141800056|SUPERIORITY_OR_OTHER||R-square|0.08||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C||||
71153751|NCT00488683|141800056|SUPERIORITY_OR_OTHER||R-square|0.1||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135||||
71153752|NCT00488683|141800056|SUPERIORITY_OR_OTHER||R-square|0.66||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135||||
71153753|NCT00488683|141800056|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y||||
70912989|NCT04310579|141316339|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.03||||0.64|TWO_SIDED|90.0|0.91|1.17||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Area under the curve was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 1 with treatment as a categorical variable and participant as a random effect||1.17|0.91|0.64
70912990|NCT04310579|141316339|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.06||||0.24|TWO_SIDED|90.0|0.98|1.15||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and quetiapine compared to oxycodone and placebo.|Area under the curve was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 1 with treatment as a categorical variable and participant as a random effect||1.15|0.98|0.24
70912991|NCT04310579|141316340|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.1||||0.05|TWO_SIDED|90.0|1.02|1.19||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Area under the curve was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 5 with treatment as a categorical variable and participant as a random effect||1.19|1.02|0.05
70912992|NCT04310579|141316340|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.27|||<|0.001|TWO_SIDED|90.0|1.19|1.36||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and quetiapine compared to oxycodone and placebo.|Area under the curve was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 5 with treatment as a categorical variable and participant as a random effect||1.36|1.19|<0.001
70912993|NCT03722446|141316388|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
70912994|NCT03722446|141316389|SUPERIORITY|||||||0.0102|||||||t-test, 1 sided|||||||0.01020
70912995|NCT03722446|141316390|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0000
70912996|NCT03722446|141316391|SUPERIORITY|||||||0.3753|||||||Chi-squared|||||||0.3753
70912997|NCT03722446|141316392|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0000
70912998|NCT03722446|141316393|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
70912999|NCT01779375|141316394|SUPERIORITY||||||>|0.05||||||All analyses were conducted with values on a log scale and re-exponentiated for presentation.|Regression, Linear|Measures of ß-cell response were modeled simultaneously with insulin sensitivity (M/I) using 2-df seemingly unrelated regression models.||Seemingly unrelated regression was used to compare treatment arms on the combination of insulin sensitivity (M/I as calculated from the hyperglycemic clamp) and insulin secretion (steady-state C-peptide and ACPRmax as co-primary; ACPRg as major secondary,). See statistical analysis plan for further details and R code.||||>0.05
70913000|NCT01779375|141316395|SUPERIORITY||||||>|0.05|||||||Regression, Linear|||Analyses were completed on a log scale and re-exponentiated for presentation.||||>0.05
70913001|NCT01779375|141316397|SUPERIORITY||||||>|0.05|||||||Regression, Linear|||Analyses were completed on a log scale and re-exponentiated for display.||||>0.05
71153754|NCT00488683|141800056|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y||||
70913002|NCT00946192|141316426|OTHER|Least square means||||||0.039|||||||Mixed Models Analysis|||||||0.039
70913003|NCT00946192|141316427|OTHER|||||||0.018|||||||Mixed Models Analysis|||||||0.018
70913004|NCT02467491|141316537|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||t-test, 2 sided|||The Short Physical Performance Battery (SPPB) score at baseline was compared with the SPPB scored after 4 weeks of physical activity intervention with a paired t-test||||0.04
70913005|NCT02467491|141316538|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||The Short Physical Performance Battery (SPPB) score after 4 weeks of physical activity intervention was compared with the SPPB score after 2 to 3 months from the completion of the physical activity intervention with a paired t-test||||0.02
70913006|NCT03107611|141316543|SUPERIORITY|||||||0.0817|||||||Fisher Exact|||||||0.0817
70913007|NCT03107611|141316543|SUPERIORITY|||||||0.2874|||||||Fisher Exact|||||||0.2874
70913008|NCT03107611|141316544|EQUIVALENCE|Equivalence margin: -0.20, +0.20|Difference in proportions|-0.03|||||TWO_SIDED|90.0|-0.12|0.06||||||||0.06|-0.12|
70913009|NCT02145182|141316547|SUPERIORITY||Odds Ratio (OR)|0.81||||0.3983|TWO_SIDED|95.0|0.49|1.33|||Regression, Logistic|Logistic regression results for the DGF composite, the effect of treatment adjusted for preservation type, donor type, and Irish score.|Calculated using the logistic regression model.|Analysis of DGF composite||1.33|0.49|0.3983
70913010|NCT03102710|141316563|SUPERIORITY|Covariates included 1) age, 2) cream randomization, and 3) the difference in ERS for lidocaine before and after expectancy manipulation (which represented how well the expectancy was modulated) in Session 2.|Mean Difference (Final Values)|0.4||||0.03|TWO_SIDED|||||The threshold for significance was \<0.05.|ANCOVA||The mean difference between anodal vs. sham was 0.4, between cathodal vs. sham was 1.2, and between anodal vs. cathodal was -0.8.|To assess the modulation effects of tDCS on placebo, we first performed an analysis of covariance (ANCOVA) with placebo as the dependent variable and group (i.e., anodal, cathodal, and sham tDCS) as the fixed factor.||||0.03
70970617|NCT00531752|141447059|SUPERIORITY_OR_OTHER||LS Mean Difference|-20.3367|STANDARD_ERROR_OF_MEAN|19.6995||0.3065|TWO_SIDED|80.0|-45.89|5.2183|||Mixed Models Analysis|||Week 3 (Life productivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.2183|-45.89|0.3065
70970618|NCT00531752|141447059|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.7878|STANDARD_ERROR_OF_MEAN|13.4438||0.3831|TWO_SIDED|80.0|-29.15|5.5793|||Mixed Models Analysis|||Week 3 (Psychological health): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.5793|-29.15|0.3831
71153755|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.29||||0.08||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.08
71153756|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.05||||0.74||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.74
71153757|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.01||||0.94||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.94
71153758|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.09||||0.51||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.51
71153759|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.27||||0.12||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.12
71153760|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.25||||0.09||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.09
71153761|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.05||||0.81||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.81
71153762|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.28||||0.07||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.07
71153763|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.36||||0.02||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.02
71153764|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.08||||0.59||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.59
71153765|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.1||||0.51||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.51
71153766|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.02||||0.9||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.9
71153767|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.39||||0.02||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.02
71153768|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.19||||0.2||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.20
71153769|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.18||||0.34||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.34
71153770|NCT00488683|141800056|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.33||||0.04||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.04
71153771|NCT00488683|141800056|SUPERIORITY_OR_OTHER||R-square|0.08||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||
71153772|NCT00488683|141800056|SUPERIORITY_OR_OTHER||R-square|0.0027||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||
71153773|NCT00488683|141800056|SUPERIORITY_OR_OTHER||R-square|0.0002||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||
71153774|NCT00488683|141800056|SUPERIORITY_OR_OTHER||R-square|0.0077||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||
71153775|NCT00488683|141800056|SUPERIORITY_OR_OTHER||R-square|0.07||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||
71153776|NCT00488683|141800056|SUPERIORITY_OR_OTHER||R-square|0.06||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||
71153777|NCT00488683|141800056|SUPERIORITY_OR_OTHER||R-square|0.0023||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||
71153778|NCT00488683|141800056|SUPERIORITY_OR_OTHER||R-square|0.08||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||
71153779|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.25||||0.59||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A||||0.59
71153780|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.12||||0.68||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A||||0.68
71153781|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.36||||0.12||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C||||0.12
71153782|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.22||||0.26||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C||||0.26
71153783|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.43||||0.08||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.08
71153784|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.17||||0.42||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.42
70913011|NCT03102710|141316563|SUPERIORITY|Covariates included 1) age, 2) cream randomization, and 3) the difference in ERS for capsaicin before and after expectancy manipulation (which represented how well the expectancy was modulated) in Session 2. In addition, we added the STAI state and trait anxiety scores as covariates when assessing the modulation effects of tDCS on the nocebo effect, as previous studies have suggested that anxiety level could affect nocebo hyperalgesia.|Mean Difference (Final Values)|1.3||||0.04|TWO_SIDED|||||The threshold for significance was \<0.05.|ANCOVA||The mean difference between anodal vs. sham was 1.4, between cathodal vs. sham was 1.0, and between anodal vs. cathodal was -0.3.|To assess the modulation effects of tDCS on nocebo, we first performed an analysis of covariance (ANCOVA) with nocebo as the dependent variable and group (i.e., anodal, cathodal, and sham tDCS) as the fixed factor.||||0.04
71153785|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.77||||0.02||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.02
71153786|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.12||||0.65||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.65
71153787|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.25||||0.58||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A||||0.58
71153788|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.19||||-0.51||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A||||-0.51
71153789|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.28||||0.24||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C||||0.24
71153790|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.36||||0.06||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C||||0.06
71153791|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.72||||0.001||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.001
71153792|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.32||||0.12||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.12
71153793|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.49||||0.18||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.18
71092816|NCT04133909|141692072|SUPERIORITY||Odds Ratio (OR)|0.82||||0.209|TWO_SIDED|95.0|0.6|1.12|||Regression, Logistic|||A logistic regression model was used to compare the proportion of responders between the mepolizumab and placebo arms in the mITT and mITT2 populations. The model includes fixed categorical covariates (treatment group, smoking status, geographic region) and a fixed continuous covariate (baseline score).||1.12|0.60|0.209
71092817|NCT04133909|141692073|SUPERIORITY||Rate ratio (Mepolizumab 100/Placebo)|0.65||||0.032|TWO_SIDED|95.0|0.43|0.96|||Negative binomial model|||Analysis performed using a negative binomial model with covariates of treatment group, geographic region, number of moderate/severe exacerbations in previous year (\<=2, 3, \>=4 as ordinal), baseline % predicted FEV1 and smoking status (current vs. former smoker), and with logarithm (time on- and off-treatment) as an offset variable. Estimates based on weighting applied to each level of class variable determined from observed proportions.||0.96|0.43|0.032
71092818|NCT01299909|141692075|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.35|TWO_SIDED|95.0|0.67|3.51|||Regression, Logistic|||||3.51|0.67|0.35
71092819|NCT01299909|141692076|SUPERIORITY||Mean Difference (Final Values)|4.81||||0.03|TWO_SIDED||||||ANOVA|df=(1,57)||||||0.03
71092820|NCT01299909|141692077|SUPERIORITY||Mean Difference (Final Values)|6.09||||0.02|TWO_SIDED||||||ANOVA|df=(1,57)||||||0.02
71092821|NCT01299909|141692078|SUPERIORITY||Mean Difference (Final Values)|4.96||||0.03|TWO_SIDED||||||ANOVA|df=(1,57)||||||0.03
71092822|NCT05399485|141692149|SUPERIORITY||[Difference in Least square (LS) Mean]|-1.1||||0.0021|TWO_SIDED|95.0|-1.73|-0.38|||Mixed Models Analysis|||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as a covariate, treatment group, randomization stratum (stable prophylactic migraine medication use throughout randomization), month, and month-by treatment group interaction as fixed effects.||-0.38|-1.73|0.0021
71092823|NCT05399485|141692150|SUPERIORITY||Difference in Percentage|7.3||||0.0989|TWO_SIDED|95.0|-1.4|15.9||P-value \>0.05; therefore, all secondary outcome measures listed after this outcome measure in the hierarchy were not tested.|Mantel Haenszel|||The percentages of participants with reductions were compared between treatment groups using Mantel-Haenszel risk estimation with stratification by randomization stratum (stable prophylactic migraine medication use throughout randomization; yes, no).||15.9|-1.4|0.0989
71092824|NCT02469233|141692202|SUPERIORITY||Time by treatment interaction coeff.|-3.18||||0.025|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.025
71092825|NCT02469233|141692202|SUPERIORITY||Time by treatment interaction coeff.|-1.52||||0.28|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.28
70913012|NCT01101165|141316568|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|96.6|||||TWO_SIDED|90.0|92.8|100.56|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||100.56|92.80|
70913013|NCT01101165|141316569|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|94.8|||||TWO_SIDED|90.0|92.42|97.24|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||97.24|92.42|
70913014|NCT01101165|141316570|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|95.5|||||TWO_SIDED|90.0|92.93|98.18|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||98.18|92.93|
71092826|NCT02469233|141692203|SUPERIORITY||time by treatment interaction coeff.|-5.88||||0.001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.001
71092827|NCT02469233|141692203|SUPERIORITY||maximum likelihood estimation|-3.9||||0.03|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.03
71092828|NCT02469233|141692204|SUPERIORITY||time by treatment interaction coeff.|-5.55|||<|0.0001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||<0.0001
71092829|NCT02469233|141692204|SUPERIORITY||Time by treatment interaction coeff.|-4.92|||<|0.0001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||<0.0001
71092830|NCT02469233|141692205|SUPERIORITY||Time by treatment interaction coeff.|-9.14|||<|0.0001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||<0.0001
71092831|NCT02469233|141692205|SUPERIORITY||Time by treatment interaction coeff.|-5.37||||0.027|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.027
71092832|NCT02469233|141692206|SUPERIORITY||Time by treatment interaction coeff.|-0.95||||0.32|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.32
70913015|NCT00335556|141316571|OTHER||Log Rank Test Statistic|5.419||||0.0199|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients with Stage II-IV diffuse anaplastic Wilms' tumor on AREN0321 and NWTS-5 (NCT00002610) were compared using the log-rank test.||||.0199
70913016|NCT00335556|141316572|OTHER||Log Rank Test Statistic|0.8814||||0.3478|TWO_SIDED|95.0|||||Log Rank|||The overall survival distributions of patients with Stage I-IV malignant rhabdoid tumors on AREN0321 and National Wilms Tumor Study-5 -- Treatment of Relapsed Patients, A National Wilms Tumor Study Group Phase III Study (NCT00002610) were compared using the log-rank test.||||.3478
70913017|NCT00335556|141316574|OTHER||Log Rank Test Statistic|3.6216||||0.057|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients with Stage I focal and diffuse anaplastic Wilms tumors on AREN0321 and National Wilms Tumor Study-5 -- Treatment of Relapsed Patients, A National Wilms Tumor Study Group Phase III Study (NCT00002610) were compared using the log-rank test.||||.0570
70913018|NCT03404843|141316594|OTHER|||||||0.97|||||||ANOVA|||Within group comparison of treatment||||0.97
70913019|NCT03404843|141316594|OTHER||||||<|0.05|||||||ANOVA|||Within group comparison of treatment||||<0.05
70913020|NCT03404843|141316595|OTHER||||||<|0.05|||||||ANOVA|||Within group comparison of treatment||||<0.05
70913021|NCT03404843|141316595|OTHER||||||<|0.05|||||||ANOVA|||Within group comparison of treatment||||<0.05
70913022|NCT03404843|141316596|OTHER|||||||0.28|||||||ANOVA|||Within group comparison of treatment||||0.28
70913023|NCT03404843|141316596|OTHER|||||||0.37|||||||ANOVA|||Within group comparison of treatment||||0.37
70913024|NCT03404843|141316597|OTHER|||||||0.89|||||||ANOVA|||Within group comparison of treatment||||0.89
70913025|NCT03404843|141316597|OTHER|||||||0.3|||||||ANOVA|||Within group comparison of treatment||||0.30
70913026|NCT03404843|141316598|OTHER|||||||0.08|||||||ANOVA|||Within group comparison of treatment||||0.08
70913027|NCT03404843|141316598|OTHER|||||||0.05|||||||ANOVA|||Within group comparison of treatment||||0.05
70913028|NCT00567164|141316600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.85|STANDARD_DEVIATION|30.356||0.0001||95.0|-16.3|-7.394|||t-test, 2 sided|||||-7.394|-16.3|0.0001
70913029|NCT01664104|141316736|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value was calculated between baseline versus change at Month 3.|Wilcoxon test|||||||<0.0001
70913030|NCT01664104|141316736|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value was calculated between baseline versus change at Month 6.|Wilcoxon test|||||||<0.0001
70913031|NCT01664104|141316737|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value was calculated between baseline versus change at Month 3.|Wilcoxon test|||||||<0.0001
70913032|NCT01664104|141316737|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon test|P-value was calculated between baseline versus change at Month 6.||||||<0.0001
70913033|NCT01664104|141316738|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon test|P-value was calculated between baseline versus change at Month 3.||||||<0.0001
70913034|NCT01664104|141316738|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon test|P-value was calculated between baseline versus change at Month 6.||||||<0.0001
70913035|NCT01664104|141316758|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value was calculated between baseline versus change at Month 3.|Wilcoxon test|||||||<0.0001
70913036|NCT01664104|141316758|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value was calculated between baseline versus change at Month 6.|Wilcoxon test|||||||<0.0001
70913037|NCT01664104|141316759|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value was calculated between baseline versus change at Month 3.|Wilcoxon test|||||||<0.0001
70913038|NCT01664104|141316759|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value was calculated between baseline versus change at Month 6.|Wilcoxon test|||||||<0.0001
70913039|NCT01664104|141316760|SUPERIORITY_OR_OTHER|||||||0.6904|||||||t-test|P-value signifies CRP at the start of TCZ treatment by remission status using DAS28-CRP (remission versus no remission).||||||0.6904
70913040|NCT01664104|141316760|SUPERIORITY_OR_OTHER|||||||0.6032|||||||t-test|P-value signifies the CRP at the start of TCZ treatment by remission status using SDAI (remission versus no remission).||||||0.6032
70913041|NCT01664104|141316760|SUPERIORITY_OR_OTHER|||||||0.6146|||||||t-test|P-value signifies the CRP at the start of TCZ treatment by remission status using CDAI (remission versus no remission).||||||0.6146
70913042|NCT01664104|141316761|SUPERIORITY_OR_OTHER|||||||0.0018|||||||t-test|P-value signifies the BMI at the start of TCZ treatment by remission status using DAS28-CRP (remission versus no remission).||||||0.0018
70913043|NCT01664104|141316761|SUPERIORITY_OR_OTHER|||||||0.1617|||||||t-test|P-value signifies the BMI at the start of TCZ treatment by remission status using SDAI (remission versus no remission).||||||0.1617
70913044|NCT01664104|141316761|SUPERIORITY_OR_OTHER|||||||0.1296|||||||t-test|P-value signifies the BMI at the start of TCZ treatment by remission status using CDAI (remission versus no remission).||||||0.1296
70913045|NCT01664104|141316764|SUPERIORITY_OR_OTHER|||||||0.5332|||||||t-test|P-value signifies the CRP at the start of TCZ treatment using the morning stiffness ( ≤ 30 minutes versus \> 30 minutes).||||||0.5332
70913046|NCT01664104|141316765|SUPERIORITY_OR_OTHER|||||||0.6159|||||||t-test|P-value signifies the BMI at the start of TCZ treatment using the morning stiffness ( ≤ 30 minutes versus \> 30 minutes).||||||0.6159
70913047|NCT01664104|141316766|SUPERIORITY_OR_OTHER|||||||0.237|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient between CRP at the start of TCZ treatment versus HAQ-DI (0-3) at Month 6.||||||0.2370
70913048|NCT01664104|141316766|SUPERIORITY_OR_OTHER|||||||0.8033|||||||Spearman Correlation|P-value was calculated from Spearman correlation coefficient between CRP at the start of TCZ treatment versus HAQ-D1 (0-3) at Month 6.||||||0.8033
70913049|NCT01664104|141316767|SUPERIORITY_OR_OTHER|||||||0.0306|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient for change from baseline in CRP versus change from baseline in HAQ-DI (0-3) at Month 6.||||||0.0306
70913050|NCT01664104|141316767|SUPERIORITY_OR_OTHER|||||||0.0749|||||||Spearman Correlation|P-value was calculated from Spearman correlation coefficient for change from baseline in CRP versus change from baseline in HAQ-DI (0-3) at Month 6.||||||0.0749
70913051|NCT01664104|141316768|SUPERIORITY_OR_OTHER|||||||0.4854|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient between CRP at the start of TCZ treatment versus VAS fatigue at Month 6.||||||0.4854
70913052|NCT01664104|141316768|SUPERIORITY_OR_OTHER|||||||0.325|||||||S|P-value was calculated from Spearman correlation coefficient between CRP at the start of TCZ treatment versus VAS fatigue at Month 6.||||||0.3250
70913053|NCT01664104|141316769|SUPERIORITY_OR_OTHER|||||||0.0011|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient between change from baseline in CRP versus change from baseline in VAS fatigue at Month 6.||||||0.0011
70913054|NCT01664104|141316769|SUPERIORITY_OR_OTHER|||||||0.0013|||||||Spearman Correlation|P-value calculated from Spearman correlation coefficient between change from baseline in CRP versus change from baseline in VAS fatigue at Month 6.||||||0.0013
70913055|NCT01664104|141316770|SUPERIORITY_OR_OTHER|||||||0.5655|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient between BMI at the start of TCZ treatment versus HAQ-DI (0-3) at Month 6.||||||0.5655
70913056|NCT01664104|141316770|SUPERIORITY_OR_OTHER|||||||0.3977|||||||Spearman Correlation|P-value was calculated from Spearman correlation coefficient between BMI at the start of TCZ treatment versus HAQ-DI (0-3) at Month 6.||||||0.3977
70913057|NCT01664104|141316771|SUPERIORITY_OR_OTHER|||||||0.0123|||||||Pearson correlation|P-value obtained from Pearson correlation coefficient between change from baseline in CRP versus change from baseline in morning stiffness at Month 6.||||||0.0123
70913058|NCT01664104|141316771|SUPERIORITY_OR_OTHER|||||||0.0151|||||||Spearman Correlation|P-value obtained from Spearman correlation coefficient between change from baseline in CRP versus change from baseline in morning stiffness at Month 6||||||0.0151
70913059|NCT01664104|141316772|SUPERIORITY_OR_OTHER|||||||0.9909|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient between BMI at the start of TCZ treatment versus VAS fatigue at Month 6.||||||0.9909
70913060|NCT01664104|141316772|SUPERIORITY_OR_OTHER|||||||0.6482|||||||Spearman Correlation|P-value was calculated from Spearman correlation coefficient between BMI at the start of TCZ treatment versus VAS fatigue at Month 6.||||||0.6482
70913061|NCT03582956|141316816|SUPERIORITY|||||||0.525|||||||t-test, 2 sided|||||||0.525
70913062|NCT03582956|141316817|SUPERIORITY|||||||0.607|||||||t-test, 2 sided|||||||0.607
70913063|NCT03582956|141316818|SUPERIORITY|||||||0.466|||||||t-test, 2 sided|||||||0.466
70913064|NCT03582956|141316819|SUPERIORITY|||||||0.414|||||||t-test, 2 sided|||||||0.414
70913065|NCT00517933|141316845|SUPERIORITY_OR_OTHER|||||||0.39|||||||Chi-squared|||||||0.39
70913066|NCT00517933|141316847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.7||||0.11|TWO_SIDED|95.0|-3.9|37.3|||Regression, Linear|||||37.3|-3.9|0.11
70913067|NCT00517933|141316848|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Log Rank|||||||0.41
70913068|NCT00517933|141316849|SUPERIORITY_OR_OTHER||Slope|-6.58|STANDARD_ERROR_OF_MEAN|2.3||0.006|TWO_SIDED|95.0|-11.25|-1.92|||Mixed Models Analysis|||||-1.92|-11.25|0.006
70913069|NCT00517933|141316851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.7|TWO_SIDED|95.0|-0.05|0.07|||Mixed Models Analysis|||||0.07|-0.05|0.70
70913070|NCT00517933|141316853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.04|TWO_SIDED|95.0|0.1|3.0|||Mixed Models Analysis|||||3.0|0.1|0.04
70913071|NCT00517933|141316855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.16|TWO_SIDED|95.0|-0.81|0.14|||Regression, Linear|||||0.14|-0.81|0.16
70913072|NCT00517933|141316857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1||||0.01|TWO_SIDED|95.0|-7.3|-0.9|||Regression, Linear|||||-0.9|-7.3|0.01
70913073|NCT00517933|141316859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.02|TWO_SIDED|95.0|-10.6|-0.9|||Regression, Linear|||||-0.9|-10.6|0.02
70913074|NCT00517933|141316861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.04|TWO_SIDED|95.0|-7.2|-0.1|||Regression, Linear|||||-0.1|-7.2|0.04
70913075|NCT00517933|141316863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7||||0.07|TWO_SIDED|95.0|-7.8|0.4|||Regression, Logistic|||||0.4|-7.8|0.07
70913076|NCT00517933|141316865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.18|TWO_SIDED|95.0|-0.01|0.06|||Regression, Linear|||||0.06|-0.01|0.18
70913077|NCT00517933|141316867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3||||0.37|TWO_SIDED|95.0|-2.8|7.3|||Regression, Linear|||||7.3|-2.8|0.37
70913078|NCT00517933|141316871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9||||0.008|TWO_SIDED|95.0|0.8|5.0|||Regression, Linear|||||5.0|0.8|0.008
70913079|NCT00517933|141316873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.86|TWO_SIDED|95.0|-2.1|1.7|||Regression, Linear|||||1.7|-2.1|0.86
70913080|NCT04807517|141316886|OTHER|Within-group test for 16-week change|||||<|0.001|||||||Regression, Linear|Repeated measures linear regression||||||<0.001
70913081|NCT01018511|141316902|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Overall power was 90% power for non-inferiority vs placebo for total IPSS. Only the FDC(s) that succeeded in stage 1 were evaluated in stage 2 for total IPSS. If both FDCs succeeded in stage 1, then both FDCs proceeded to stage 2 and the Hochberg procedure was implemented at one-sided alpha = 0.025. If one FDC succeeded in stage 1, then only this FDC proceeded to stage 2 and the FDC vs. TOCAS alone for non-inferiority was assessed at one-sided alpha = 0.025/2 = 0.0125.|Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.41||0.001|TWO_SIDED|97.5|-1.73|0.11||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The non-inferiority of FDC vs TOCAS on the change from baseline to end of treatment in total IPSS. A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS.||0.11|-1.73|0.001
70925904|NCT03637660|141345676|NON_INFERIORITY|The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.|Difference of proportion of participants|-0.05||||0.022|TWO_SIDED|90.0|-0.17|0.07||P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) in HIV-infected participants by Farrington-Manning method with a 10% margin.|Farrington-Manning|||The number and proportion of participants with serological response by month 6 among participants with HIV infection and the 95% confidence interval (CI) were summarized overall and by treatment status. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis was that the difference in serological response rate between the three-dose and one-dose groups was at least 10%.||0.07|-0.17|0.022
71092833|NCT02469233|141692206|SUPERIORITY||Time by treatment interaction coeff.|-1.67||||0.08|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.08
70913082|NCT01018511|141316902|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Only the FDC(s) that succeeded in stage 1 were evaluated in stage 2 for total IPSS. If both FDCs succeeded in stage 1, then both FDCs proceeded to stage 2 and the Hochberg procedure was implemented at one-sided alpha = 0.025. If one FDC succeeded in stage 1, then only this FDC proceeded to stage 2 and the FDC vs. TOCAS alone for non-inferiority was assessed at one-sided alpha = 0.025/2 = 0.0125.|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.41||0.028|TWO_SIDED|97.5|-1.22|0.64||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The non-inferiority of FDC vs. TOCAS on the change from baseline to end of treatment in total IPSS. A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS.||0.64|-1.22|0.028
70913083|NCT01018511|141316902|SUPERIORITY_OR_OTHER_LEGACY|||||||0.048|TWO_SIDED|||||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of FDC vs. TOCAS on the change from baseline to end of treatment in total IPSS.||||0.048
70913084|NCT01018511|141316902|SUPERIORITY_OR_OTHER_LEGACY|||||||0.483|TWO_SIDED|||||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of FDC vs. TOCAS on the change from baseline to end of treatment in total IPSS.||||0.483
70913085|NCT01018511|141316902|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.4|-0.9||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of the FDC vs placebo on the change from baseline to end of treatment in total IPSS. A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS.||-0.9|-2.4|<0.001
70913086|NCT01018511|141316902|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.41||0.006|TWO_SIDED|95.0|-1.9|-0.3||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of the FDC vs. placebo on the change from baseline to end of treatment in total IPSS. A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS.||-0.3|-1.9|0.006
70913087|NCT01018511|141316902|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.41||0.039|TWO_SIDED|95.0|-1.6|0.0||No adjustments for multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of TOCAS vs. placebo on the change from baseline to end of treatment in total IPSS. With a sample size of 274 participants per arm, the overall power to meet this outcome measure was 97% power for superiority vs placebo for total IPSS.||-0.0|-1.6|0.039
71092834|NCT02469233|141692207|SUPERIORITY||Time by treatment interaction coeff.|-0.09||||0.72|TWO_SIDED||||||intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.72
71092835|NCT02469233|141692207|SUPERIORITY||Time by treatment interaction coeff.|-0.08||||0.74|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.74
71092836|NCT02469233|141692208|SUPERIORITY||Time by treatment interaction coeff.|-2.46||||0.73|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.73
71092837|NCT02469233|141692208|SUPERIORITY||Time by treatment interaction coeff.|-17.52||||0.02|TWO_SIDED||||||intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.02
71092838|NCT02469233|141692209|SUPERIORITY||Time by treatment interaction coeff.|5.68||||0.03|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||SE mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.03
71092839|NCT02469233|141692209|SUPERIORITY||Time by treatment interaction coeff.|5.89||||0.03|TWO_SIDED||||||intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||SE mean (min): Treatment effect on change from pre to 6-month follow-up.||||0.03
70913088|NCT01018511|141316903|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.64||0.025|TWO_SIDED|97.5|-2.9|0.0||The primary analysis was adjusted for multiplicity for TUS using the Hochberg procedure.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of FDC 0.4 mg/6 mg vs. TOCAS in the change from baseline to end of treatment in TUS. A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS.||0.0|-2.9|0.025
70913089|NCT01018511|141316903|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.64||0.162|TWO_SIDED|97.5|-2.3|0.5||The primary analysis was adjusted for multiplicity for TUS using the Hochberg procedure.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of FDC 0.4 mg/6 mg vs. TOCAS in the change from baseline to end of treatment in TUS. A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS.||0.5|-2.3|0.162
70970619|NCT00531752|141447059|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.1401|STANDARD_ERROR_OF_MEAN|14.4478||0.3657|TWO_SIDED|80.0|-31.8|5.5241|||Mixed Models Analysis|||Week 3 (Psychological health): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.5241|-31.80|0.3657
70970620|NCT00531752|141447059|SUPERIORITY_OR_OTHER||LS Mean Difference|2.666|STANDARD_ERROR_OF_MEAN|11.5818||0.8188|TWO_SIDED|80.0|-12.36|17.69|||Mixed Models Analysis|||Week 3 (Life outlook): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||17.690|-12.36|0.8188
70970621|NCT00531752|141447059|SUPERIORITY_OR_OTHER||LS Mean Difference|24.1011|STANDARD_ERROR_OF_MEAN|12.405||0.0566|TWO_SIDED|80.0|8.0305|40.172|||Mixed Models Analysis|||Week 3 (Life outlook): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||40.172|8.0305|0.0566
70970622|NCT00531752|141447059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7559|STANDARD_ERROR_OF_MEAN|8.7164||0.9312|TWO_SIDED|80.0|-10.55|12.057|||Mixed Models Analysis|||Week 3 (Relationships): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||12.057|-10.55|0.9312
70970623|NCT00531752|141447059|SUPERIORITY_OR_OTHER||LS Mean Difference|6.1138|STANDARD_ERROR_OF_MEAN|9.4361||0.5194|TWO_SIDED|80.0|-6.108|18.336|||Mixed Models Analysis|||Week 3 (Relationships): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||18.336|-6.108|0.5194
70970624|NCT00531752|141447060|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3255|STANDARD_ERROR_OF_MEAN|0.332||0.332|TWO_SIDED|80.0|-0.7573|0.10622|||Mixed Models Analysis|||Week 3 (Work/school): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.10622|-0.7573|0.3320
70970625|NCT00531752|141447060|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4255|STANDARD_ERROR_OF_MEAN|0.3871||0.2767|TWO_SIDED|80.0|-0.0769|0.92804|||Mixed Models Analysis|||Week 3 (Work/school): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.92804|-0.0769|0.2767
70970626|NCT00531752|141447060|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3661|STANDARD_ERROR_OF_MEAN|0.4028||0.3675|TWO_SIDED|80.0|-0.8887|0.1566|||Mixed Models Analysis|||Week 3 (Social life): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.15660|-0.8887|0.3675
70970627|NCT00531752|141447060|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1033|STANDARD_ERROR_OF_MEAN|0.4372||0.8141|TWO_SIDED|80.0|-0.67|0.46345|||Mixed Models Analysis|||Week 3 (Social life): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.46345|-0.6700|0.8141
70970628|NCT00531752|141447060|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1854|STANDARD_ERROR_OF_MEAN|0.3702||0.6186|TWO_SIDED|80.0|-0.6657|0.29495|||Mixed Models Analysis|||Week 3 (Family life/home): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.29495|-0.6657|0.6186
70970629|NCT00531752|141447060|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3623|STANDARD_ERROR_OF_MEAN|0.4028||0.372|TWO_SIDED|80.0|-0.1597|0.88432|||Mixed Models Analysis|||Week 3 (Family life/home): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.88432|-0.1597|0.3720
70970630|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|25.0781|STANDARD_ERROR_OF_MEAN|5.0238|<|0.0001|TWO_SIDED|80.0|18.565|31.591|||Mixed Models Analysis|||Week 1 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||31.591|18.565|<0.0001
70970631|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|15.6481|STANDARD_ERROR_OF_MEAN|5.3551||0.0049|TWO_SIDED|80.0|8.711|22.585|||Mixed Models Analysis|||Week 1 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||22.585|8.7110|0.0049
70970632|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.627|STANDARD_ERROR_OF_MEAN|3.5248||0.3078|TWO_SIDED|80.0|-8.196|0.94237|||Mixed Models Analysis|||Week 1 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.94237|-8.196|0.3078
70970633|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|7.1594|STANDARD_ERROR_OF_MEAN|3.8022||0.0644|TWO_SIDED|80.0|2.2344|12.084|||Mixed Models Analysis|||Week 1 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||12.084|2.2344|0.0644
71092840|NCT02469233|141692209|SUPERIORITY||Time by treatment interaction coeff.|-1.45||||0.43|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||SE variability (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.43
70913090|NCT01018511|141316903|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|-4.9|-2.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of FDC 0.4 mg/6 mg vs. placebo on the change from baseline to end of treatment in TUS.||-2.5|-4.9|<0.001
70913091|NCT01018511|141316903|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-3.2|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|-4.4|-1.9||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of FDC 0.4 mg/9 mg vs. placebo on the change from baseline to end of treatment in TUS.||-1.9|-4.4|<0.001
70913092|NCT01018511|141316903|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-3.5|-1.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of TOCAS vs. placebo on the change from baseline to end of treatment in TUS.||-1.0|-3.5|<0.001
70913093|NCT01018511|141316904|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.0|-0.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||-0.3|-1.0|<0.001
70913094|NCT01018511|141316904|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.223|TWO_SIDED|95.0|-0.6|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.1|-0.6|0.223
70913095|NCT01018511|141316904|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.5|-0.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.8|-1.5|< 0.001
70913096|NCT01018511|141316904|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.1|-0.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs placebo.||-0.4|-1.1|< 0.001
70913097|NCT01018511|141316904|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.002|TWO_SIDED|95.0|-0.9|-0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.2|-0.9|0.002
70913098|NCT01018511|141316905|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|23.1|STANDARD_ERROR_OF_MEAN|3.33|<|0.001|TWO_SIDED|95.0|16.6|29.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||29.6|16.6|< 0.001
70913099|NCT01018511|141316905|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|23.2|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|16.6|29.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||29.8|16.6|< 0.001
70913100|NCT01018511|141316905|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|27.4|STANDARD_ERROR_OF_MEAN|3.27|<|0.001|TWO_SIDED|95.0|21.0|33.9||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||33.9|21.0|< 0.001
70913101|NCT01018511|141316905|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|27.6|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|21.1|34.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||34.1|21.1|< 0.001
70913102|NCT01018511|141316905|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.4|STANDARD_ERROR_OF_MEAN|3.32||0.189|TWO_SIDED|95.0|-2.2|10.9||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs placebo.||10.9|-2.2|0.189
70913103|NCT01018511|141316906|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|14.5|STANDARD_ERROR_OF_MEAN|7.51||0.053|TWO_SIDED|95.0|-0.2|29.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||29.3|-0.2|0.053
70913104|NCT01018511|141316906|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|14.7|STANDARD_ERROR_OF_MEAN|7.59||0.053|TWO_SIDED|95.0|-0.2|29.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||29.6|-0.2|0.053
70913105|NCT01018511|141316906|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|18.5|STANDARD_ERROR_OF_MEAN|7.37||0.012|TWO_SIDED|95.0|4.1|33.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||33.0|4.1|0.012
71153794|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.25||||0.34||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.34
70913106|NCT01018511|141316906|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|18.7|STANDARD_ERROR_OF_MEAN|7.45||0.012|TWO_SIDED|95.0|4.1|33.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||33.4|4.1|0.012
70913107|NCT01018511|141316906|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.0|STANDARD_ERROR_OF_MEAN|7.49||0.591|TWO_SIDED|95.0|-10.7|18.7||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||18.7|-10.7|0.591
70913108|NCT01018511|141316907|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.25||0.616|TWO_SIDED|95.0|-0.6|0.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.4|-0.6|0.616
70913109|NCT01018511|141316907|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.25||0.319|TWO_SIDED|95.0|-0.7|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.2|-0.7|0.319
70913110|NCT01018511|141316907|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.5|-0.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.6|-1.5|< 0.001
70913111|NCT01018511|141316907|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.7|-0.7||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.7|-1.7|< 0.001
70913112|NCT01018511|141316907|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.4|-0.4||No adjustments to multiplicity were made|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.4|-1.4|< 0.001
70913113|NCT01018511|141316908|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.22||0.591|TWO_SIDED|95.0|-0.3|0.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.5|-0.3|0.591
70913114|NCT01018511|141316908|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.102|TWO_SIDED|95.0|-0.1|0.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.8|-0.1|0.102
70913115|NCT01018511|141316908|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.204|TWO_SIDED|95.0|-0.6|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.1|-0.6|0.204
70913116|NCT01018511|141316908|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.19||0.936|TWO_SIDED|95.0|-0.4|0.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.4|-0.4|0.936
70913117|NCT01018511|141316908|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.081|TWO_SIDED|95.0|-0.8|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.0|-0.8|0.081
70913118|NCT01018511|141316909|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.24||0.511|TWO_SIDED|95.0|-0.3|0.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.6|-0.3|0.511
70913119|NCT01018511|141316909|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.24||0.182|TWO_SIDED|95.0|-0.2|0.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.8|-0.2|0.182
70913120|NCT01018511|141316909|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.22||0.552|TWO_SIDED|95.0|-0.6|0.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.3|-0.6|0.552
70913121|NCT01018511|141316909|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.22||0.891|TWO_SIDED|95.0|-0.4|0.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo||0.5|-0.4|0.891
70913122|NCT01018511|141316909|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.23||0.215|TWO_SIDED|95.0|-0.8|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.2|-0.8|0.215
70913123|NCT01018511|141316910|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.383|TWO_SIDED|95.0|-0.2|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs TOCAS.||0.1|-0.2|0.383
70913124|NCT01018511|141316910|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.08||0.402|TWO_SIDED|95.0|-0.1|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.2|-0.1|0.402
70913125|NCT01018511|141316910|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.021|TWO_SIDED|95.0|-0.3|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.0|-0.3|0.021
70913126|NCT01018511|141316910|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.584|TWO_SIDED|95.0|-0.2|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.1|-0.2|0.584
70913127|NCT01018511|141316910|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.166|TWO_SIDED|95.0|-0.3|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.0|-0.3|0.166
70913128|NCT01018511|141316911|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.187|TWO_SIDED|95.0|-1.0|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.2|-1.0|0.187
70913129|NCT01018511|141316911|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.31||0.203|TWO_SIDED|95.0|-1.0|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.2|-1.0|0.203
70913130|NCT01018511|141316911|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.29||0.09|TWO_SIDED|95.0|-1.1|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.1|-1.1|0.090
70913131|NCT01018511|141316911|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.29||0.098|TWO_SIDED|95.0|-1.1|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.1|-1.1|0.098
70913132|NCT01018511|141316911|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.31||0.772|TWO_SIDED|95.0|-0.7|0.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.5|-0.7|0.772
70913133|NCT01018511|141316912|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.27||0.21|TWO_SIDED|95.0|-0.9|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.2|-0.9|0.210
70913134|NCT01018511|141316912|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.28||0.775|TWO_SIDED|95.0|-0.5|0.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.6|-0.5|0.775
70913135|NCT01018511|141316912|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.27||0.01|TWO_SIDED|95.0|-1.2|-0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.2|-1.2|0.010
70913136|NCT01018511|141316912|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.27||0.317|TWO_SIDED|95.0|-0.8|0.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.3|-0.8|0.317
70913137|NCT01018511|141316912|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.27||0.196|TWO_SIDED|95.0|-0.9|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.2|-0.9|0.196
70913138|NCT01018511|141316913|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.009|TWO_SIDED|95.0|-0.9|-0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||-0.1|-0.9|0.009
71092841|NCT02469233|141692209|SUPERIORITY||Time by treatment interaction coeff.|-1.55||||0.4|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||SE variability (min): Treatment effect on change from pre to 6-month follow-up.||||0.40
70913139|NCT01018511|141316913|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.045|TWO_SIDED|95.0|-0.8|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||-0.0|-0.8|0.045
70913140|NCT01018511|141316913|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.4|-0.7||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.7|-1.4|< 0.001
70913141|NCT01018511|141316913|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.011|TWO_SIDED|95.0|-0.9|-0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.1|-0.9|0.011
70913142|NCT01018511|141316913|SUPERIORITY_OR_OTHER_LEGACY||Least squares men difference|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.3|-0.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.5|-1.3|< 0.001
70913143|NCT01018511|141316914|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.008|TWO_SIDED|95.0|-0.5|-0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||-0.1|-0.5|0.008
70970634|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|4.5601|STANDARD_ERROR_OF_MEAN|3.1318||0.1517|TWO_SIDED|80.0|0.49198|8.6281|||Mixed Models Analysis|||Week 1 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||8.6281|0.49198|0.1517
71092842|NCT02469233|141692210|SUPERIORITY||Time by treatment interaction coeff.|-12.68||||0.59|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TST mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.59
70970635|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7384|STANDARD_ERROR_OF_MEAN|3.3281||0.8252|TWO_SIDED|80.0|-5.056|3.5789|||Mixed Models Analysis|||Week 1 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.5789|-5.056|0.8252
70970636|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6228|STANDARD_ERROR_OF_MEAN|0.2203||0.0063|TWO_SIDED|80.0|-0.9082|-0.3375|||Mixed Models Analysis|||Week 1 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.3375|-0.9082|0.0063
71092843|NCT02469233|141692210|SUPERIORITY||Time by treatment interaction coeff.|-28.33||||0.22|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TST mean (min): Treatment effect on change from pre to 6-month follow-up.||||0.22
71092844|NCT02469233|141692210|SUPERIORITY||Time by treatment interaction coeff.|4.65||||0.8|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TST variability (min) : Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.80
71092845|NCT02469233|141692210|SUPERIORITY||Time by treatment interaction coeff.|-7.57||||0.68|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TST variability (min): Treatment effect on change from pre to 6-month follow-up.||||0.68
71092846|NCT02469233|141692211|SUPERIORITY||Time by treatment interaction coeff.|-76.85||||0.34|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Waking activity count mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.34
71092847|NCT02469233|141692211|SUPERIORITY||Time by treatment interaction coeff.|-87.15||||0.28|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Waking activity count mean (min): Treatment effect on change from pre to 6-month follow-up.||||0.28
71092848|NCT02469233|141692211|SUPERIORITY||Time by treatment interaction coeff.|-0.15||||0.18|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Waking activity count variability (min) : Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.18
71092849|NCT02469233|141692211|SUPERIORITY||Time by treatment interaction coeff.|-0.27||||0.02|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Waking activity count variability (min): Treatment effect on change from pre to 6-month follow-up.||||0.02
71092850|NCT02469233|141692212|SUPERIORITY||Time by treatment interaction coeff.|-7.19||||0.09|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.09
71092851|NCT02469233|141692212|SUPERIORITY||Time by treatment interaction coeff.|-1.13||||0.79|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcome.||Treatment effect on change from pre to 6-month follow-up||||0.79
71092852|NCT02469233|141692213|SUPERIORITY||Time by treatment interaction coeff.|0.16||||0.46|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcome,||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.46
71092853|NCT02469233|141692213|SUPERIORITY||Time by treatment interaction coeff.|-0.34||||0.1|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.10
71092854|NCT02469233|141692214|SUPERIORITY||Time by treatment interaction coeff.|0.91||||0.002|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.002
71092855|NCT02469233|141692214|SUPERIORITY||Time by treatment interaction coeff.|0.64||||0.03|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up.||||0.03
71092856|NCT02469233|141692215|SUPERIORITY||Time by treatment interaction coeff.|24.85||||0.23|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Means of Total sleep time: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.23
71092857|NCT02469233|141692215|SUPERIORITY||Time by treatment interaction coeff.|34.31||||0.09|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Means of total sleep time: Treatment effect on change from pre to 6-month follow-up||||0.09
70913144|NCT01018511|141316914|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.021|TWO_SIDED|95.0|-0.4|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||-0.0|-0.4|0.021
70913145|NCT01018511|141316914|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.2|-0.6|< 0.001
70913146|NCT01018511|141316914|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.2|-0.6|< 0.001
70913147|NCT01018511|141316914|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.139|TWO_SIDED|95.0|-0.3|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.0|-0.3|0.139
70913148|NCT01018511|141316916|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-2.1|STANDARD_ERROR_OF_MEAN|1.14||0.068|TWO_SIDED|95.0|-4.3|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.2|-4.3|0.068
70913149|NCT01018511|141316916|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-2.7|STANDARD_DEVIATION|1.15||0.02|TWO_SIDED|95.0|-4.9|-0.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||-0.4|-4.9|0.020
70913150|NCT01018511|141316916|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-4.7|STANDARD_ERROR_OF_MEAN|1.12|<|0.001|TWO_SIDED|95.0|-6.9|-2.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-2.5|-6.9|< 0.001
70913151|NCT01018511|141316916|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-5.3|STANDARD_ERROR_OF_MEAN|1.13|<|0.001|TWO_SIDED|95.0|-7.5|-3.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs placebo.||-3.1|-7.5|< 0.001
70913152|NCT01018511|141316916|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-2.6|STANDARD_ERROR_OF_MEAN|1.14||0.022|TWO_SIDED|95.0|-4.8|0.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.4|-4.8|0.022
70913153|NCT01018511|141316917|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|3.0|STANDARD_ERROR_OF_MEAN|1.16||0.011|TWO_SIDED|95.0|0.7|5.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs TOCAS.||5.2|0.7|0.011
70913154|NCT01018511|141316917|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.5|STANDARD_ERROR_OF_MEAN|1.17||0.035|TWO_SIDED|95.0|0.2|4.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||4.8|0.2|0.035
70913155|NCT01018511|141316917|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|5.1|STANDARD_ERROR_OF_MEAN|1.14|<|0.001|TWO_SIDED|95.0|2.8|7.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||7.3|2.8|< 0.001
70913156|NCT01018511|141316917|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.6|STANDARD_ERROR_OF_MEAN|1.15|<|0.001|TWO_SIDED|95.0|2.3|6.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||6.8|2.3|< 0.001
70913157|NCT01018511|141316917|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.1|STANDARD_ERROR_OF_MEAN|1.16||0.068|TWO_SIDED|95.0|-0.2|4.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||4.4|-0.2|0.068
70913158|NCT01018511|141316918|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.6|STANDARD_ERROR_OF_MEAN|1.07||0.013|TWO_SIDED|95.0|0.5|4.7||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||4.7|0.5|0.013
70913159|NCT01018511|141316918|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.2|STANDARD_ERROR_OF_MEAN|1.08||0.043|TWO_SIDED|95.0|0.1|4.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||4.3|0.1|0.043
70913160|NCT01018511|141316918|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.4|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED|95.0|2.4|6.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||6.5|2.4|< 0.001
70970637|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2301|STANDARD_ERROR_OF_MEAN|0.2303||0.3217|TWO_SIDED|80.0|-0.5283|0.06822|||Mixed Models Analysis|||Week 1 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.06822|-0.5283|0.3217
70913161|NCT01018511|141316918|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.0|STANDARD_ERROR_OF_MEAN|1.06|<|0.001|TWO_SIDED|95.0|1.9|6.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||6.1|1.9|< 0.001
70913162|NCT01018511|141316918|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.8|STANDARD_ERROR_OF_MEAN|1.06||0.092|TWO_SIDED|95.0|-0.3|3.9||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||3.9|-0.3|0.092
70913163|NCT01018511|141316919|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|3.1|STANDARD_ERROR_OF_MEAN|1.21||0.011|TWO_SIDED|95.0|0.7|5.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||5.5|0.7|0.011
70913164|NCT01018511|141316919|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.2|STANDARD_ERROR_OF_MEAN|1.23||0.314|TWO_SIDED|95.0|-1.2|3.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||3.6|-1.2|0.314
70913165|NCT01018511|141316919|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|3.6|STANDARD_ERROR_OF_MEAN|1.19||0.003|TWO_SIDED|95.0|1.2|5.9||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||5.9|1.2|0.003
70913166|NCT01018511|141316919|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.7|STANDARD_ERROR_OF_MEAN|1.21||0.161|TWO_SIDED|95.0|-0.7|4.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||4.1|-0.7|0.161
70913167|NCT01018511|141316919|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.5|STANDARD_ERROR_OF_MEAN|1.21||0.708|TWO_SIDED|95.0|-1.9|2.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||2.8|-1.9|0.708
70913168|NCT01018511|141316920|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.7|STANDARD_ERROR_OF_MEAN|0.83||0.043|TWO_SIDED|95.0|0.1|3.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||3.3|0.1|0.043
70913169|NCT01018511|141316920|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.3|STANDARD_ERROR_OF_MEAN|0.84||0.12|TWO_SIDED|95.0|-0.3|3.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||3.0|-0.3|0.120
70913170|NCT01018511|141316920|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.4|STANDARD_ERROR_OF_MEAN|0.82||0.003|TWO_SIDED|95.0|0.8|4.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||4.0|0.8|0.003
70913171|NCT01018511|141316920|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.0|STANDARD_ERROR_OF_MEAN|0.83||0.014|TWO_SIDED|95.0|0.4|3.7||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs placebo.||3.7|0.4|0.014
70913172|NCT01018511|141316920|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.83||0.384|TWO_SIDED|95.0|-0.9|2.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||2.4|-0.9|0.384
70913173|NCT01018511|141316921|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.6|STANDARD_ERROR_OF_MEAN|0.92||0.004|TWO_SIDED|95.0|0.8|4.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||4.4|0.8|0.004
70913174|NCT01018511|141316921|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.0|STANDARD_ERROR_OF_MEAN|0.93||0.035|TWO_SIDED|95.0|0.1|3.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||3.8|0.1|0.035
70913175|NCT01018511|141316921|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.0|STANDARD_ERROR_OF_MEAN|0.91|<|0.001|TWO_SIDED|95.0|2.2|5.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||5.8|2.2|< 0.001
70913176|NCT01018511|141316921|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|3.3|STANDARD_ERROR_OF_MEAN|0.92|<|0.001|TWO_SIDED|95.0|1.5|5.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||5.1|1.5|< 0.001
70970638|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1291|STANDARD_ERROR_OF_MEAN|0.1065||0.2307|TWO_SIDED|80.0|-0.0091|0.26716|||Mixed Models Analysis|||Week 1 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.26716|-0.0091|0.2307
70913177|NCT01018511|141316921|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.4|STANDARD_ERROR_OF_MEAN|0.92||0.142|TWO_SIDED|95.0|-0.5|3.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||3.2|-0.5|0.142
70913178|NCT01018511|141316922|SUPERIORITY_OR_OTHER_LEGACY|||||||0.874|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS (superiority test).||||0.874
70913179|NCT01018511|141316922|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS (superiority test).||||0.240
70913180|NCT01018511|141316922|SUPERIORITY_OR_OTHER_LEGACY|||||||0.324|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo (superiority test).||||0.324
70913181|NCT01018511|141316922|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo (superiority test).||||0.043
71153795|NCT00488683|141800057|SUPERIORITY_OR_OTHER||R-square|0.06||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A||||
70913182|NCT01018511|141316922|SUPERIORITY_OR_OTHER_LEGACY|||||||0.407|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo (superiority test).||||0.407
70913183|NCT01018511|141316929|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.||||<.001
70913184|NCT01018511|141316929|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.||||<.001
70913185|NCT01018511|141316929|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||<.001
70913186|NCT01018511|141316929|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||<.001
70913187|NCT01018511|141316929|SUPERIORITY_OR_OTHER_LEGACY|||||||0.058|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||0.058
70913188|NCT01018511|141316930|SUPERIORITY_OR_OTHER_LEGACY|||||||0.053|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.||||0.053
70913189|NCT01018511|141316930|SUPERIORITY_OR_OTHER_LEGACY|||||||0.031|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.||||0.031
70970639|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08114|STANDARD_ERROR_OF_MEAN|0.1087||0.4585|TWO_SIDED|80.0|-0.0598|0.22209|||Mixed Models Analysis|||Week 1 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.22209|-0.0598|0.4585
70913190|NCT01018511|141316930|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||<.001
70913191|NCT01018511|141316930|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||<.001
70913192|NCT01018511|141316930|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||0.018
70913193|NCT01018511|141316931|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.||||0.110
70970640|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.6629|STANDARD_ERROR_OF_MEAN|3.8642||0.3477|TWO_SIDED|80.0|-8.681|1.3549|||Mixed Models Analysis|||Week 1 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.3549|-8.681|0.3477
70970641|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.8688|STANDARD_ERROR_OF_MEAN|4.0842||0.1565|TWO_SIDED|80.0|-11.17|-0.5693|||Mixed Models Analysis|||Week 1 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.5693|-11.17|0.1565
70970642|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.4319|STANDARD_ERROR_OF_MEAN|3.9541||0.1088|TWO_SIDED|80.0|-11.55|-1.311|||Mixed Models Analysis|||Week 1 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.311|-11.55|0.1088
70970643|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7208|STANDARD_ERROR_OF_MEAN|4.1517||0.8627|TWO_SIDED|80.0|-4.654|6.0952|||Mixed Models Analysis|||Week 1 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.0952|-4.654|0.8627
70970644|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|56.631|STANDARD_ERROR_OF_MEAN|17.8056||0.0024|TWO_SIDED|80.0|33.532|79.73|||Mixed Models Analysis|||Week 1 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||79.730|33.532|0.0024
70970645|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|49.1543|STANDARD_ERROR_OF_MEAN|18.7622||0.0112|TWO_SIDED|80.0|24.831|73.478|||Mixed Models Analysis|||Week 1 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||73.478|24.831|0.0112
70970646|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|10.9197|STANDARD_ERROR_OF_MEAN|3.0912||0.0008|TWO_SIDED|80.0|6.9105|14.929|||Mixed Models Analysis|||Week 1 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||14.929|6.9105|0.0008
70970647|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|8.4691|STANDARD_ERROR_OF_MEAN|3.3037||0.0129|TWO_SIDED|80.0|4.1876|12.751|||Mixed Models Analysis|||Week 1 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||12.751|4.1876|0.0129
70970648|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|14.1078|STANDARD_ERROR_OF_MEAN|4.3667||0.002|TWO_SIDED|80.0|8.4492|19.766|||Mixed Models Analysis|||Week 2 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||19.766|8.4492|0.0020
70970649|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|14.3485|STANDARD_ERROR_OF_MEAN|4.5692||0.0026|TWO_SIDED|80.0|8.4275|20.27|||Mixed Models Analysis|||Week 2 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||20.270|8.4275|0.0026
70970650|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2989|STANDARD_ERROR_OF_MEAN|3.4103||0.9305|TWO_SIDED|80.0|-4.729|4.1309|||Mixed Models Analysis|||Week 2 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.1309|-4.729|0.9305
70970651|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.7062|STANDARD_ERROR_OF_MEAN|3.5839||0.1178|TWO_SIDED|80.0|-10.36|-1.05|||Mixed Models Analysis|||Week 2 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.050|-10.36|0.1178
71092858|NCT02469233|141692215|SUPERIORITY||Time by treatment interaction coeff.|-19.9||||0.19|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Variability of Total sleep time: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.19
70913194|NCT01018511|141316931|SUPERIORITY_OR_OTHER_LEGACY|||||||0.071|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.||||0.071
70913195|NCT01018511|141316931|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||<.001
70913196|NCT01018511|141316931|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||<.001
70913197|NCT01018511|141316931|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||0.019
70913198|NCT04888585|141316971|SUPERIORITY||Response Rate Difference|21.2|||<|0.001|TWO_SIDED|95.0|11.5|31.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||31.0|11.5|<0.001
70913199|NCT04888585|141316971|SUPERIORITY||Response Rate Difference|26.6|||<|0.001|TWO_SIDED|95.0|16.5|36.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||36.7|16.5|<0.001
70913200|NCT04888585|141316971|SUPERIORITY||Response Rate Difference|37.7|||<|0.001|TWO_SIDED|95.0|27.4|48.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||48.1|27.4|<0.001
70913201|NCT04888585|141316971|SUPERIORITY||Response Rate Difference|23.2|||<|0.001|TWO_SIDED|95.0|13.8|32.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||32.6|13.8|<0.001
70913202|NCT04888585|141316972|SUPERIORITY||Least Squares (LS) Mean Difference|-0.51||||0.007|TWO_SIDED|95.0|-0.87|-0.14|||Mixed Models Analysis|MMRM includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 40mg - Placebo|||-0.14|-0.87|0.007
70913203|NCT04888585|141316972|SUPERIORITY||Least Squares (LS) Mean Difference|-1.01|||<|0.001|TWO_SIDED|95.0|-1.38|-0.64|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||-0.64|-1.38|<0.001
70913204|NCT04888585|141316972|SUPERIORITY||Least Squares (LS) Mean Difference|-1.42|||<|0.001|TWO_SIDED|95.0|-1.8|-1.05|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||-1.05|-1.80|<0.001
70913205|NCT04888585|141316972|SUPERIORITY||Least Squares (LS) Mean Difference|-0.62|||<|0.001|TWO_SIDED|95.0|-0.99|-0.26|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 340 E4W - Placebo|||-0.26|-0.99|<0.001
70913206|NCT04888585|141316973|SUPERIORITY||Least Squares (LS) Mean Difference|-4.56||||0.014|TWO_SIDED|95.0|-8.21|-0.92|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||-0.92|-8.21|0.014
70913207|NCT04888585|141316973|SUPERIORITY||Least Squares (LS) Mean Difference|-8.01|||<|0.001|TWO_SIDED|95.0|-11.7|-4.31|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||-4.31|-11.70|<0.001
70913208|NCT04888585|141316973|SUPERIORITY||Least Squares (LS) Mean Difference|-11.41|||<|0.001|TWO_SIDED|95.0|-15.1|-7.73|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||-7.73|-15.10|<0.001
70913209|NCT04888585|141316973|SUPERIORITY||Least Squares (LS) Mean Difference|-5.29||||0.004|TWO_SIDED|95.0|-8.89|-1.69|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||-1.69|-8.89|0.004
70913210|NCT04888585|141316974|SUPERIORITY||Response Rate Difference|24.7|||<|0.001|TWO_SIDED|95.0|12.1|37.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||37.3|12.1|<0.001
70970652|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4586|STANDARD_ERROR_OF_MEAN|2.5231||0.3339|TWO_SIDED|80.0|-0.8124|5.7295|||Mixed Models Analysis|||Week 2 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.7295|-0.8124|0.3339
70970653|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|4.859|STANDARD_ERROR_OF_MEAN|2.63||0.0698|TWO_SIDED|80.0|1.4493|8.2686|||Mixed Models Analysis|||Week 2 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||8.2686|1.4493|0.0698
70913211|NCT04888585|141316974|SUPERIORITY||Response Rate Difference|30.2|||<|0.001|TWO_SIDED|95.0|17.4|42.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||42.9|17.4|<0.001
70913212|NCT04888585|141316974|SUPERIORITY||Response Rate Difference|45.4|||<|0.001|TWO_SIDED|95.0|33.5|57.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||57.4|33.5|<0.001
70913213|NCT04888585|141316974|SUPERIORITY||Response Rate Difference|24.6|||<|0.001|TWO_SIDED|95.0|11.9|37.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||37.3|11.9|<0.001
71153796|NCT00488683|141800057|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A||||
70913214|NCT04888585|141316975|SUPERIORITY||Response Rate Difference|6.5||||0.031|TWO_SIDED|95.0|0.6|12.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||12.4|0.6|0.031
70913215|NCT04888585|141316975|SUPERIORITY||Response Rate Difference|9.8||||0.007|TWO_SIDED|95.0|2.7|17.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||17.0|2.7|0.007
70913216|NCT04888585|141316975|SUPERIORITY||Response Rate Difference|10.9||||0.004|TWO_SIDED|95.0|3.6|18.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||18.2|3.6|0.004
70913217|NCT04888585|141316975|SUPERIORITY||Response Rate Difference|0.9||||0.709|TWO_SIDED|95.0|-4.0|5.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||5.9|-4.0|0.709
70913218|NCT04888585|141316976|SUPERIORITY||Response Rate Difference|16.9||||0.006|TWO_SIDED|95.0|4.9|28.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||28.9|4.9|0.006
70913219|NCT04888585|141316976|SUPERIORITY||Response Rate Difference|25.8|||<|0.001|TWO_SIDED|95.0|13.5|38.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||38.1|13.5|<0.001
70913220|NCT04888585|141316976|SUPERIORITY||Response Rate Difference|31.5|||<|0.001|TWO_SIDED|95.0|18.9|44.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||44.2|18.9|<0.001
70913221|NCT04888585|141316976|SUPERIORITY||Response Rate Difference|23.2|||<|0.001|TWO_SIDED|95.0|11.0|35.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||35.4|11.0|<0.001
70913222|NCT04888585|141316977|SUPERIORITY||Response Rate Difference|14.1||||0.022|TWO_SIDED|95.0|2.0|26.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||26.2|2.0|0.022
70913223|NCT04888585|141316977|SUPERIORITY||Response Rate Difference|22.8|||<|0.001|TWO_SIDED|95.0|10.0|35.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||35.5|10.0|<0.001
70913224|NCT04888585|141316977|SUPERIORITY||Response Rate Difference|24.3|||<|0.001|TWO_SIDED|95.0|11.6|37.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||37.0|11.6|<0.001
70913225|NCT04888585|141316977|SUPERIORITY||Response Rate Difference|12.6||||0.042|TWO_SIDED|95.0|0.5|24.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||24.7|0.5|0.042
70913226|NCT04888585|141316978|SUPERIORITY||Response Rate Difference|5.1||||0.296|TWO_SIDED|95.0|-4.4|14.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||14.6|-4.4|0.296
70913227|NCT04888585|141316978|SUPERIORITY||Response Rate Difference|19.5|||<|0.001|TWO_SIDED|95.0|8.7|30.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||30.2|8.7|<0.001
70913228|NCT04888585|141316978|SUPERIORITY||Response Rate Difference|25.5|||<|0.001|TWO_SIDED|95.0|14.3|36.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||36.7|14.3|<0.001
70913229|NCT04888585|141316978|SUPERIORITY||Response Rate Difference|14.1||||0.007|TWO_SIDED|95.0|3.8|24.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||24.5|3.8|0.007
70913230|NCT04888585|141316979|SUPERIORITY||Response Rate Difference|7.1||||0.017|TWO_SIDED|95.0|1.3|13.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||13.0|1.3|0.017
70913231|NCT04888585|141316979|SUPERIORITY||Response Rate Difference|2.0||||0.424|TWO_SIDED|95.0|-2.8|6.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||6.8|-2.8|0.424
70913232|NCT04888585|141316979|SUPERIORITY||Response Rate Difference|2.6||||0.303|TWO_SIDED|95.0|-2.3|7.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||7.5|-2.3|0.303
70913233|NCT04888585|141316979|SUPERIORITY||Response Rate Difference|1.3||||0.551|TWO_SIDED|95.0|-2.9|5.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340 E4W - Placebo|||5.4|-2.9|0.551
70913234|NCT04888585|141316980|SUPERIORITY||Least Squares (LS) Mean Difference|-0.18||||0.022|TWO_SIDED|95.0|-0.33|-0.03|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|ABBV-154 40mg EOW - Placebo|||-0.03|-0.33|0.022
70913235|NCT04888585|141316980|SUPERIORITY||Least Squares (LS) Mean Difference|-0.25||||0.001|TWO_SIDED|95.0|-0.41|-0.1|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||-0.10|-0.41|0.001
70913236|NCT04888585|141316980|SUPERIORITY||Least Squares (LS) Mean Difference|-0.32|||<|0.001|TWO_SIDED|95.0|-0.48|-0.17|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||-0.17|-0.48|<0.001
71153797|NCT00488683|141800057|SUPERIORITY_OR_OTHER||R-square|0.13||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C||||
70913237|NCT04888585|141316980|SUPERIORITY||Least Squares (LS) Mean Difference|-0.21||||0.007|TWO_SIDED|95.0|-0.36|-0.06|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||-0.06|-0.36|0.007
70913238|NCT01391013|141317010|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.08
70913239|NCT01391013|141317011|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.88
70913240|NCT01391013|141317012|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.31
70913241|NCT01391013|141317013|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.37
70913242|NCT01391013|141317014|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.66
70913243|NCT01391013|141317015|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.02
70913244|NCT01391013|141317016|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.12
70913245|NCT01391013|141317017|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.71
70913246|NCT01391013|141317018|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.83
70913247|NCT01391013|141317019|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.66
70913248|NCT01391013|141317020|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.76
70913249|NCT01391013|141317021|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.56
70913250|NCT01391013|141317022|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.11
70913251|NCT01391013|141317023|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.18
70913252|NCT01391013|141317024|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.03
70913253|NCT01391013|141317025|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.04
70913254|NCT00299702|141317029|SUPERIORITY_OR_OTHER|||||||0.684||||||Hochberg procedure was used for adjusting multiple endpoint comparisons|Log Rank|Insufficient number of subjects who had an event for median estimation.||Null hypothesis: there is no difference in time to relapse||||0.684
70913255|NCT00299702|141317030|SUPERIORITY_OR_OTHER|||||||0.646||||||Hochberg procedure was used for adjusting multiple endpoint comparisons|Wilcoxon (Mann-Whitney)|||Null hypothesis: there is no difference in time in remission between the two treatment groups||||0.646
70913256|NCT05460663|141317035|EQUIVALENCE|Paired Wilcoxon signed ranks tests were used to compare changes at 12-week, 18-week, or 24-week follow-ups from the baseline scores for all measurements in each training modality separately and combined. Comparisons were made with participants who had data at both baseline and the follow-up. Difference-in-difference comparison of changes between two training modalities at each follow-up from the baseline were made to assess differences between CBT and in-person training.||||||0.083||||||The reported P-value is for differences between groups at 24-weeks post-intervention.The Benjamini \& Hochberg adjustment was applied to control for the false-discovery rate among all pairwise pre-post comparisons.|Wilcoxon (Mann-Whitney)|||||||.083
70913257|NCT05273801|141317039|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||How frequently clinician ask about RPE/HR during session||||0.73
70913258|NCT05273801|141317039|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||How frequently education provided regarding HR/RPE during session||||0.05
70913259|NCT05273801|141317039|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||How frequently HR/RPE target is mentioned in session||||0.007
70913260|NCT05273801|141317039|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||How frequently clinician modifies session/task to reach HR/RPE target||||0.005
70913261|NCT05273801|141317039|SUPERIORITY|||||||1e-05|||||||t-test, 2 sided|||How frequently clinicians monitor HR/RPE during session||||0.00001
70913262|NCT03820986|141317041|SUPERIORITY|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by BRAF mutation positive (Yes vs. No).|Hazard Ratio (HR)|0.83||||0.0295||95.0|0.69|1.0|||Log Rank|One-sided p-value based on log-rank test and stratified by BRAF mutation positive (Yes vs. No).|HR=Pembrolizumab + Lenvatinib vs. Pembrolizumab + Placebo|||1.00|0.69|0.0295
70913263|NCT03820986|141317042|SUPERIORITY|HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by BRAF mutation positive (Yes vs. No).|Hazard Ratio (HR)|1.2||||0.9521|TWO_SIDED|95.0|0.97|1.48|||Log Rank|One-sided p-value based on log-rank test and stratified by BRAF mutation positive (Yes vs. No).|HR=Pembrolizumab + Lenvatinib vs. Pembrolizumab + Placebo|||1.48|0.97|0.9521
70913264|NCT03820986|141317047|OTHER||Difference in LS means|-3.69||||0.0345|TWO_SIDED|95.0|-7.1|-0.27|||cLDA model||Difference in LS means=Pembrolizumab + Lenvatinib vs. Pembrolizumab + Placebo|Based on a constrained longitudinal data analysis (cLDA) model with GHS/QoL as the response variable, with covariates for treatment by time interaction, stratification factor BRAF mutation status as covariate.||-0.27|-7.10|0.0345
70913265|NCT03820986|141317048|OTHER||Difference in LS means|-5.49||||0.0004|TWO_SIDED|95.0|-8.53|-2.45|||cLDA model||Difference in LS means=Pembrolizumab + Lenvatinib vs. Pembrolizumab + Placebo|Based on a cLDA model with PF as the response variable, with covariates for treatment by time interaction, stratification factor BRAF mutation status as covariate.||-2.45|-8.53|0.0004
70913266|NCT03820986|141317049|OTHER||Hazard Ratio (HR)|1.58||||0.0001|TWO_SIDED|95.0|1.25|2.0|||Log Rank||HR=Lenvatinib + Pembrolizumab vs. Placebo + Pembrolizumab|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by BRAF mutation status (positive vs wild type or unknown)||2.00|1.25|0.0001
70913267|NCT03820986|141317050|OTHER||Hazard Ratio (HR)|1.95||||0.0001|TWO_SIDED|95.0|1.52|2.5|||Log Rank||HR=Lenvatinib + Pembrolizumab vs. Placebo + Pembrolizumab|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by BRAF mutation status (positive vs wild type or unknown).||2.50|1.52|.0001
70913268|NCT01729819|141317051|SUPERIORITY|The change in mean nocturnal voids from baseline as the dependent variable, baseline mean nocturnal voids as a covariate, and treatments and visit (Month 1, Month 2, and Month 3) as factors, was considered for the analysis. Longitudinal analysis based on repeated measures using analysis of covariance with subject as random effect. Missing values post-baseline were not imputed.|Mean Difference (Final Values)|-0.34||||0.112|TWO_SIDED|95.0|-0.77|0.08|||ANCOVA|Change in mean nocturnal voids as the dependent variable and baseline mean nocturnal voids as a covariate, treatment and visit as factors.|Longitudinal analysis based on repeated measures using analysis of covariance with subject as random effect. The estimated value represents the contrast of combination - tolterodine.|Combination versus tolterodine (i.e. effect in combination group minus effect in tolterodine group) is presented. The trial was to be declared positive if a statistically significant (two-sided, p \< 0.05) positive effect for combining tolterodine and desmopressin compared to tolterodine monotherapy on the primary endpoint had been demonstrated.||0.08|-0.77|0.112
70913269|NCT01729819|141317052|SUPERIORITY||Mean Difference (Final Values)|18.0||||0.385|TWO_SIDED|95.0|-22.96|58.96|||ANCOVA|Change in mean time to first void as dependent variable and baseline mean time to first void as a covariate, and treatment and visit as factors.|The estimated value represents the contrast of combination - tolterodine.|Combination versus tolterodine (i.e. effect in combination group minus effect in tolterodine group) is presented.||58.96|-22.96|0.385
70913270|NCT01729819|141317053|SUPERIORITY||Mean Difference (Final Values)|-64.16||||0.103|TWO_SIDED|95.0|-141.46|13.14|||ANCOVA|Change in mean nocturnal volume as the dependent variable and baseline mean nocturnal volume as a covariate, and treatment and visit as factors.|The estimated value represents the contrast of combination - tolterodine.|Combination versus tolterodine (i.e. effect in combination group minus effect in tolterodine group) is presented||13.14|-141.46|0.103
70913271|NCT01729819|141317054|SUPERIORITY||Odds Ratio (OR)|1.36||||0.352|TWO_SIDED|95.0|0.71|2.62||33% responder status as dependent variable, baseline mean nocturnal voids as covariate, treatment, and visit as factors.|Generalized Estimating Equation|||Combination versus tolterodine (i.e. odds of being responder in combination group versus odds of being responder in tolterodine group) is presented. The proportion of responders during three months of treatment was analysed (i.e. the odds ratio of the odds of being a responder) longitudinally using Generalised Estimating Equation (GEE) for a repeated logistic regression.||2.62|0.71|0.352
70913272|NCT01729819|141317055|SUPERIORITY|Estimated contrast (Combination - tolterodine) from longitudinal analysis including a treatment-by visit interaction term||||||0.443||||||Adjusted treatment difference (Combination-tolterodine) in mean number of nocturnal voids at Month 1|ANCOVA|||Treatment difference (Combination-tolterodine) at Month 1||||0.443
70913273|NCT01729819|141317055|SUPERIORITY|Estimated contrast (Combination - tolterodine) from longitudinal analysis including a treatment-by visit interaction term||||||0.086||||||Adjusted treatment difference in mean number of nocturnal voids (Combination-tolterodine) at Month 2|ANCOVA|||Treatment difference (Combination-tolterodine) at Month 2||||0.086
70913274|NCT01729819|141317055|SUPERIORITY|Estimated contrast (Combination - tolterodine) from longitudinal analysis including a treatment-by visit interaction term||||||0.055||||||Adjusted treatment difference (Combination-tolterodine) in mean number of nocturnal voids at Month 3|ANCOVA|||Treatment difference (Combination-tolterodine) at Month 3||||0.055
70913275|NCT01729819|141317055|SUPERIORITY|Estimated contrast (Combination - tolterodine) from longitudinal analysis including a treatment-by visit interaction term||||||0.106||||||Adjusted treatment difference (Combination-tolterodine) in mean number of nocturnal voids for the duration of 3 months|ANCOVA|||Treatment difference (Combination-tolterodine) for the duration of 3 months||||0.106
71092859|NCT02469233|141692215|SUPERIORITY||Time by treatment interaction coeff.|-1.76||||0.91|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Variability of Total sleep time: Treatment effect on change from pre to 6-month follow-up||||0.91
71092860|NCT02469233|141692216|SUPERIORITY||Time by treatment interaction coeff.|-39.33||||0.04|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.04
71092861|NCT02469233|141692216|SUPERIORITY||Time by treatment interaction coeff.|-28.56||||0.13|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT mean (min): Treatment effect on change from pre to 6-month follow-up.||||0.13
71153798|NCT00488683|141800057|SUPERIORITY_OR_OTHER||R-square|0.05||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C||||
70913276|NCT01729819|141317056|SUPERIORITY||Mean Difference (Final Values)|0.42||||0.178|TWO_SIDED|95.0|-0.2|1.05|||ANCOVA|Quality of sleep rating score as dependent variable, baseline quality of sleep rating scale value as a covariate, and responder status as a factor.|Estimated contrast (Combination - tolterodine) from longitudinal analysis of covariance|"Combination versus tolterodine (i.e. score on scale in combination group versus score on scale in tolterodine group) is presented.Statistical analysis for from very tired to wide awake, how do you feel now"||1.05|-0.20|0.178
70913277|NCT01729819|141317056|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.257|TWO_SIDED|95.0|-0.26|0.94|||ANCOVA|Quality of sleep rating score as dependent variable, baseline quality of sleep rating scale value as a covariate, and responder status as a factor.|Estimated contrast (Combination - tolterodine) from longitudinal analysis of covariance|"Combination versus tolterodine (i.e. score on scale in combination group versus score on scale in tolterodine group) is presented. Statistical analysis for Rate how refreshed you feel now"||0.94|-0.26|0.257
70913278|NCT01729819|141317056|SUPERIORITY|Quality of sleep rating score as dependent variable, baseline quality of sleep rating scale value as a covariate, and responder status as a factor.|Mean Difference (Final Values)|0.28||||0.36|TWO_SIDED|95.0|-0.32|0.88|||ANCOVA|Longitudinal analysis of covariance on change from baseline with baseline as a covariate, and treatment and visit as factors.|Estimated contrast (Combination - tolterodine) from longitudinal analysis of covariance|"Combination versus tolterodine (i.e. score on scale in combination group versus score on scale in tolterodine group) is presented. Statistical analysis for Rate the quality of your sleep last night"||0.88|-0.32|0.360
70913279|NCT01020838|141317088|SUPERIORITY_OR_OTHER||Sensitivity|0.774|||||TWO_SIDED|95.0|0.654|0.894|||||Point estimate of sensitivity was calculated by the method of Rao and Scott. Variance for sensitivity is based on subjects that contribute at least one brain region, which is amyloid positive according to the SoT|"For the primary analysis, point estimates together with normal-approximated, two sided 95% confidence intervals, were given for sensitivity in beta-amyloid detection based on the majority read.~The following hypothesis was formulated for sensitivity:~H0,sens: sensitivity ≤ 0.6 vs. H1, sens: sensitivity \> 0.6 H0,sens was to be rejected if the lower bound of the two-sided 95% CI is larger than 0.6"||0.894|0.654|
70913280|NCT01020838|141317088|SUPERIORITY_OR_OTHER||Specificity|0.942|||||TWO_SIDED|95.0|0.886|0.998|||||Point estimate of specificity was calculated using the method of Rao and Scott. Variance for specificity is based on subjects that contribute at least one brain region, which is amyloid negative according to the SoT|"For the primary analysis, point estimates together with normal-approximated, two sided 95% confidence intervals, were given for specificity in amyloid detection based on the majority read.~The following hypothesis was formulated for specificity:~H0,spec: specificity ≤ 0.8 vs. H1, spec: specificity \> 0.8 H0,spec was to be rejected if the lower bound of the two-sided 95% CI is larger than 0.8"||0.998|0.886|
70913281|NCT01167426|141317094|SUPERIORITY_OR_OTHER||Difference in mean ranks|79.6|||<|0.0001||95.0|||||Wilcoxon Signed-Rank||Difference in mean ranks between Week 2 and Week 6|Comparison of Week 2 (20 mg/1.0 mL utilizing autoject 2 for glass syringe) to Week 6 (20 mg/0.5 mL utilizing the autoject 2 20 mg/0.5 mL).||||<0.0001
70913282|NCT01167426|141317095|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Goodness-of-fit p-value comparing overall preference to expected frequencies of 33.3% in each category. That is, no preference across the full sample of patients in the study.|Chi-squared|||||||<0.0001
70913283|NCT00558363|141317126|SUPERIORITY_OR_OTHER||Relative Risk (Hazard Ratio)|0.34|||<|0.001|TWO_SIDED|95.0|0.23|0.5||Comparing 24-month survival curves (includes time to PSA doubling as well as time to censoring); stratified by site cluster and previous therapy|Log Rank||Relative risk of dutasteride compared to placebo, derived from Cox Proportional Hazard model stratified by site cluster and previous therapy|||0.50|0.23|<0.001
70913284|NCT00558363|141317136|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparing percentages of participants with PSA doubling: 57% versus 28%|Mantel-Haenszel Chi-Square|||||||<0.001
70913285|NCT00558363|141317137|SUPERIORITY_OR_OTHER||Relative Risk (Hazard Ratio)|0.25|||<|0.001||95.0|0.14|0.45||Comparing 12-month survival curves (includes time to PSA doubling as well as time to censoring); stratified by site cluster and previous therapy|Log Rank||Relative risk of dutasteride compared to placebo, derived from Cox proportional hazard model stratified by site cluster and previous therapy|||0.45|0.14|<0.001
70913286|NCT00558363|141317138|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparing percentages of participants with PSA doubling: 35% versus 10%|Mantel-Haenszel Chi-Square|||||||<0.001
70913287|NCT02219490|141317168|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
70913288|NCT02219490|141317168|SUPERIORITY||Cox Proportional Hazard Ratio|0.126|||<|0.001|TWO_SIDED|95.0|0.044|0.358|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.358|0.044|<0.001
70913289|NCT02219490|141317169|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
70913290|NCT02219490|141317169|SUPERIORITY||Cox Proportional Hazard Ratio|0.031||||0.007|TWO_SIDED|95.0|0.003|0.38|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.380|0.003|0.007
70913291|NCT02219490|141317170|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
70913292|NCT02219490|141317170|SUPERIORITY||Cox Proportional Hazard Ratio|0.038|||<|0.001|TWO_SIDED|95.0|0.009|0.156|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.156|0.009|<0.001
70913293|NCT02219490|141317171|SUPERIORITY|||||||0.86|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||0.860
70970654|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3364|STANDARD_ERROR_OF_MEAN|0.1859||0.0762|TWO_SIDED|80.0|-0.5777|-0.095|||Mixed Models Analysis|||Week 2 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.0950|-0.5777|0.0762
71153799|NCT00488683|141800057|SUPERIORITY_OR_OTHER||R-square|0.19||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135||||
70913294|NCT02219490|141317171|SUPERIORITY|||||||0.997||||||The Hazard Ratio for experiencing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to those who did not achieve SVR12 is infinite and the CI is not bounded due to zero events in one of the groups.|Cox proportional hazards model|||A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||||0.997
70913295|NCT02219490|141317172|SUPERIORITY|||||||0.608|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||0.608
70913296|NCT02219490|141317172|SUPERIORITY|||||||0.992||||||The Hazard Ratio for experiencing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to those who did not achieve SVR12 is infinite and the CI is not bounded due to zero events in one of the groups.|Cox proportional hazards model|||A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||||0.992
70913297|NCT02219490|141317173|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
70913298|NCT02219490|141317173|SUPERIORITY||Cox Proportional Hazard Ratio|0.133|||<|0.001|TWO_SIDED|95.0|0.057|0.313|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.313|0.057|<0.001
70913299|NCT02219490|141317174|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.7||0.151|TWO_SIDED|95.0|-0.37|2.37|||ANCOVA||Difference = with SVR12 minus without SVR12|"Final Treatment Visit~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||2.37|-0.37|0.151
70913300|NCT02219490|141317174|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.78||0.878|TWO_SIDED|95.0|-1.64|1.4|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 12~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||1.4|-1.64|0.878
70913301|NCT02219490|141317174|SUPERIORITY||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.72|=|0.199|TWO_SIDED|95.0|-2.33|0.48|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 24~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||0.48|-2.33|=0.199
70913302|NCT02219490|141317174|SUPERIORITY||LS Mean Difference|-2.16|STANDARD_ERROR_OF_MEAN|0.93||0.021|TWO_SIDED|95.0|-4.0|-0.33|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 52~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||-0.33|-4|0.021
70913303|NCT02219490|141317174|SUPERIORITY||LS Mean Difference|-2.47|STANDARD_ERROR_OF_MEAN|0.89||0.006|TWO_SIDED|95.0|-4.22|-0.71|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 104~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||-0.71|-4.22|0.006
70913304|NCT02219490|141317174|SUPERIORITY||LS Mean Difference|-2.58|STANDARD_ERROR_OF_MEAN|0.92||0.005|TWO_SIDED|95.0|-4.38|-0.79|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 156~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||-0.79|-4.38|0.005
70913305|NCT02219490|141317174|SUPERIORITY||LS Mean Difference|-1.36|STANDARD_ERROR_OF_MEAN|1.0||0.172|TWO_SIDED|95.0|-3.32|0.59|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 208~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||0.59|-3.32|0.172
70970655|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1591|STANDARD_ERROR_OF_MEAN|0.1913||0.4096|TWO_SIDED|80.0|-0.4075|0.08935|||Mixed Models Analysis|||Week 2 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.08935|-0.4075|0.4096
70970656|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2115|STANDARD_ERROR_OF_MEAN|0.1033||0.0455|TWO_SIDED|80.0|0.07751|0.3455|||Mixed Models Analysis|||Week 2 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.34550|0.07751|0.0455
71092862|NCT02469233|141692216|SUPERIORITY||Time by treatment interaction coeff.|-17.57||||0.21|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT variability (min) : Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.21
71092863|NCT02469233|141692216|SUPERIORITY||Time by treatment interaction coeff.|-16.05||||0.25|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT variability (min): Treatment effect on change from pre to 6-month follow-up.||||0.25
70913306|NCT02219490|141317174|SUPERIORITY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|1.14||0.322|TWO_SIDED|95.0|-3.35|1.1|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 260~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||1.1|-3.35|0.322
70913307|NCT03879642|141317194|SUPERIORITY||partial eta squared|0.117|||||TWO_SIDED||||||ANOVA|||||||
70913308|NCT03879642|141317195|SUPERIORITY||partial eta squared|0.005|||||TWO_SIDED||||||repeated measures ANOVA|||||||
70913309|NCT01879371|141317211|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|107.85|||||TWO_SIDED|90.0|105.334|110.431|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen acid film-coated tablet '.|"The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect.~The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested."||110.431|105.334|
70913310|NCT01879371|141317211|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|109.48|||||TWO_SIDED|90.0|107.072|111.936|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen lysinate film-coated tablet '.|The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.||111.936|107.072|
70913311|NCT01879371|141317212|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|99.65|||||TWO_SIDED|90.0|93.874|105.776|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen acid film-coated tablet '.|The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.||105.776|93.874|
70913312|NCT01879371|141317212|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|70.42|||||TWO_SIDED|90.0|67.087|73.928|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen lysinate film-coated tablet '.|The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.||73.928|67.087|
70913313|NCT01879371|141317213|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|106.5|||||TWO_SIDED|90.0|104.05|109.004|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen acid film-coated tablet '.|The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.||109.004|104.050|
70913314|NCT01879371|141317213|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|108.59|||||TWO_SIDED|90.0|106.185|111.054|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen lysinate film-coated tablet '.|The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.||111.054|106.185|
70913315|NCT03068611|141317217|SUPERIORITY|||||||0.9|||||||Chi-squared|||||||.90
70913316|NCT03068611|141317218|SUPERIORITY|||||||0.54|||||||Chi-squared|||||||.54
70913317|NCT03068611|141317219|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|Data were log-transformed transformed due to positive skewness||||||.36
70913318|NCT03068611|141317220|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|Data were log-transformed to correct positive skewness||||||.92
70913319|NCT04391309|141317283|SUPERIORITY|||||||0.435|||||||Log Rank|||||||0.435
70913320|NCT04391309|141317284|SUPERIORITY|||||||1|||||||Fisher Exact|||All categories included in the analysis||||1
70913321|NCT04391309|141317285|SUPERIORITY|||||||0.391|||||||Wilcoxon (Mann-Whitney)|||||||0.391
70913322|NCT04391309|141317286|SUPERIORITY|||||||0.895|||||||Wilcoxon (Mann-Whitney)|||||||0.895
70913323|NCT04391309|141317287|SUPERIORITY|||||||0.702|||||||Wilcoxon (Mann-Whitney)|||||||0.702
70913324|NCT04391309|141317288|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the analysis.||||1
70913325|NCT04391309|141317289|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the analysis||||1
71153800|NCT00488683|141800057|SUPERIORITY_OR_OTHER||R-square|0.03||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135||||
70913326|NCT04391309|141317290|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the anlysis.||||1
70913327|NCT04391309|141317291|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the analysis.||||1
70913328|NCT04391309|141317292|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the analysis.||||1
70913329|NCT04391309|141317293|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the analysis.||||1
70913330|NCT04391309|141317294|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the analysis.||||1
70913331|NCT05824351|141317313|EQUIVALENCE|Equivalence is defined as an average difference of \< or = 2|Mean of paired differences|-0.2571|STANDARD_DEVIATION|0.7|<|0.0001|TWO_SIDED||||||t-test, 1 sided|One-sided lower t-test||Draize scores for erythema/eschar and edema were summed for analysis (range of 0 to 8, where a higher score indicated greater irritation).||||<0.0001
70913332|NCT05824351|141317313|EQUIVALENCE|Equivalence is defined as an average difference of \< or = 2|Mean of paired differences|0.0294|STANDARD_DEVIATION|0.79||0.0003|TWO_SIDED||||||t-test, 1 sided|One-sided upper t-test||Draize scores for erythema/eschar and edema were summed for analysis (range of 0 to 8, where a higher score indicated greater irritation).||||0.0003
70913333|NCT02929069|141317387|SUPERIORITY||Risk Ratio (RR)|0.88||||0.52|TWO_SIDED|95.0|0.52|1.25|||Regression, Logistic|||||1.25|.52|0.52
70913334|NCT00813488|141317447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.09||0.0004|TWO_SIDED|95.0|0.06|0.2|||Mixed effects ANOVA crossover model|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID15 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.20|0.06|0.0004
70913335|NCT00813488|141317448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.2242|TWO_SIDED|95.0|-0.01|0.05||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID5 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||.05|-0.01|0.2242
70913336|NCT00813488|141317449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.05||0.0106|TWO_SIDED|95.0|0.01|0.11||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID10 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||.11|0.01|0.0106
70913337|NCT00813488|141317450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|0.21|0.4||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID30 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||.40|.21|<0.0001
70913338|NCT00813488|141317451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|0.18|0.37||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID45 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||.37|0.18|<0.0001
70970657|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08114|STANDARD_ERROR_OF_MEAN|0.1087||0.4585|TWO_SIDED|80.0|-0.0598|0.22209|||Mixed Models Analysis|||Week 2 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.22209|-0.0598|0.4585
70970658|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5433|STANDARD_ERROR_OF_MEAN|4.6662||0.9078|TWO_SIDED|80.0|-5.513|6.5995|||Mixed Models Analysis|||Week 2 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.5995|-5.513|0.9078
70913339|NCT00813488|141317452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.15||0.0002|TWO_SIDED|95.0|0.08|0.27||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID60 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.27|0.08|0.0002
70913340|NCT00813488|141317459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|||<|0.0001|TWO_SIDED|95.0|0.25|0.5|||ANOVA|||||0.50|0.25|<0.0001
70913341|NCT00813488|141317460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|||<|0.0001|TWO_SIDED|95.0|0.55|1.1|||ANOVA|||||1.10|.55|<0.0001
70913342|NCT00813488|141317461|SUPERIORITY_OR_OTHER|||||||0.5575|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.5575
70913343|NCT00813488|141317462|SUPERIORITY_OR_OTHER|||||||0.0981|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0981
70913344|NCT00813488|141317463|SUPERIORITY_OR_OTHER|||||||0.0443|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0443
70913345|NCT00813488|141317464|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0004
70913346|NCT00813488|141317465|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0001
70913347|NCT00813488|141317466|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0018
70913348|NCT00813488|141317467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|0.58|0.9||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||||0.90|0.58|<0.0001
70913349|NCT00813488|141317469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1464||||0.7012|TWO_SIDED|95.0|0.6|2.3|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||2.3|0.6|0.7012
70913350|NCT00813488|141317470|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0704||||0.6545|TWO_SIDED|95.0|0.8|1.4|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.4|0.8|0.6545
70913351|NCT00813488|141317471|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2544||||0.0407|TWO_SIDED|95.0|1.0|1.6|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.6|1.0|0.0407
70970659|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1848|STANDARD_ERROR_OF_MEAN|4.7892||0.6502|TWO_SIDED|80.0|-8.403|4.0338|||Mixed Models Analysis|||Week 2 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.0338|-8.403|0.6502
70970660|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9029|STANDARD_ERROR_OF_MEAN|3.7234||0.809|TWO_SIDED|80.0|-5.716|3.9101|||Mixed Models Analysis|||Week 2 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.9101|-5.716|0.8090
70970661|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4351|STANDARD_ERROR_OF_MEAN|3.8429||0.5282|TWO_SIDED|80.0|-2.532|7.4025|||Mixed Models Analysis|||Week 2 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||7.4025|-2.532|0.5282
70970662|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|25.3231|STANDARD_ERROR_OF_MEAN|18.8604||0.1848|TWO_SIDED|80.0|0.86393|49.782|||Mixed Models Analysis|||Week 2 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||49.782|0.86393|0.1848
70970663|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|50.4054|STANDARD_ERROR_OF_MEAN|19.481||0.0124|TWO_SIDED|80.0|25.134|75.677|||Mixed Models Analysis|||Week 2 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||75.677|25.134|0.0124
70913352|NCT00813488|141317472|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5745||||0.0007|TWO_SIDED|95.0|1.2|2.0|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||2.0|1.2|0.0007
70913353|NCT00813488|141317473|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5828||||0.0372|TWO_SIDED|95.0|1.0|2.4|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||2.4|1.0|0.0372
70913354|NCT00813488|141317474|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3722||||0.3099|TWO_SIDED|95.0|0.7|2.5|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||2.5|0.7|0.3099
70913355|NCT00813488|141317475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8434||||0.5777|TWO_SIDED|95.0|0.5|1.5|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.5|.5|0.5777
71092864|NCT02469233|141692217|SUPERIORITY||Time by treatment interaction coeff.|-0.55||||0.1|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Bedtime (BT) mean: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.10
70913356|NCT00813488|141317476|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.986||||0.9567|TWO_SIDED|95.0|0.6|1.6|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.6|0.6|0.9567
70913357|NCT00813488|141317477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1366||||0.4253|TWO_SIDED|95.0|0.8|1.6|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.6|0.8|0.4253
70913358|NCT00813488|141317478|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4269||||0.0038|TWO_SIDED|95.0|1.1|1.8|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.8|1.1|0.0038
70913359|NCT00813488|141317479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5118||||0.0012||95.0|1.2|1.9|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.9|1.2|0.0012
70913360|NCT00813488|141317480|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5826||||0.0074|TWO_SIDED|95.0|1.1|2.2|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||2.2|1.1|0.0074
70913361|NCT00813488|141317481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.059||||0.8444|TWO_SIDED|95.0|0.6|1.9|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.9|0.6|0.8444
70913362|NCT00813488|141317482|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6033|||<|0.0001|TWO_SIDED|95.0|1.4|1.8|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A cumulative logit link function and independent working correlation were applied in this model. Treatment differences for each time point were measured across all categories of responses.||1.8|1.4|<0.0001
70913363|NCT00813488|141317483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3334|||<|0.0001|TWO_SIDED|95.0|1.2|1.5|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A cumulative logit link function and independent working correlation were applied in this model. Treatment differences for each time point were measured across all categories of responses.||1.5|1.2|<0.0001
70913364|NCT00635817|141317520|SUPERIORITY_OR_OTHER|||||||0.099||||||There were no adjustments for multiple comparisons.|t-test, 2 sided|||Summary statistics were calculated and tests of significance of the change versus no change were performed.||||0.099
70913365|NCT00635817|141317520|SUPERIORITY_OR_OTHER|||||||0.074||||||There were no adjustments for multiple comparisons.|t-test, 2 sided|||Summary statistics were calculated and tests of significance of the change versus no change were performed.||||0.074
70913366|NCT00635817|141317520|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||There were no adjustments for multiple comparisons.|t-test, 2 sided|||Summary statistics were calculated and tests of significance of the change versus no change were performed.||||0.026
70913367|NCT00635817|141317520|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||There were no adjustments for multiple comparisons.|t-test, 2 sided|||Summary statistics were calculated and tests of significance of the change versus no change were performed.||||0.102
70913368|NCT00635817|141317521|SUPERIORITY_OR_OTHER|||||||0.008||||||There were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Summary statistics were calculated and tests of significance of the ratio versus 1 were performed. All analyses and summaries were conducted separately for the 2 treatment groups (subjects who received leuprolide acetate depot 11.25 mg and 30 mg).||||0.008
70913369|NCT00635817|141317521|SUPERIORITY_OR_OTHER|||||||0.002||||||There were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Summary statistics were calculated and tests of significance of the ratio versus 1 were performed. All analyses and summaries were conducted separately for the 2 treatment groups (subjects who received leuprolide acetate depot 11.25 mg and 30 mg).||||0.002
70913370|NCT00635817|141317521|SUPERIORITY_OR_OTHER|||||||0.347||||||There were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Summary statistics were calculated and tests of significance of the ratio versus 1 were performed. All analyses and summaries were conducted separately for the 2 treatment groups (subjects who received leuprolide acetate depot 11.25 mg and 30 mg).||||0.347
70913371|NCT00635817|141317521|SUPERIORITY_OR_OTHER|||||||0.15||95.0||||There were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Summary statistics were calculated and tests of significance of the ratio versus 1 were performed. All analyses and summaries were conducted separately for the 2 treatment groups (subjects who received leuprolide acetate depot 11.25 mg and 30 mg).||||0.150
70913372|NCT00470626|141317572|SUPERIORITY_OR_OTHER||Probability of Successful Retrieval|0.9||||||95.0|||||||Probability of successful retrieval is from Kaplan-Meier analysis.|||||
70970664|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|6.8658|STANDARD_ERROR_OF_MEAN|3.0205||0.0267|TWO_SIDED|80.0|2.9504|10.781|||Mixed Models Analysis|||Week 2 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||10.781|2.9504|0.0267
70970665|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|8.0855|STANDARD_ERROR_OF_MEAN|3.1677||0.0134|TWO_SIDED|80.0|3.9787|12.192|||Mixed Models Analysis|||Week 2 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||12.192|3.9787|0.0134
71153801|NCT00488683|141800057|SUPERIORITY_OR_OTHER||R-square|0.6||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y||||
70913373|NCT01720446|141317647|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of semaglutide versus placebo was considered to be confirmed if the upper limit of the two-sided 95% CI for the HR was below 1.8 or equivalent if the p-value for the one-sided test of: H0: HR ≥ 1.8 against Ha: HR \<1.8 was less than 2.5% (or equivalent to 5% for a two-sided test).|Hazard Ratio (HR)|0.74|||<|0.0001|TWO_SIDED|95.0|0.58|0.95||The 'p-value' is for the two-sided Wald test of non-inferiority with limit 1.8.|Regression, Cox||Semaglutide/Placebo|The primary endpoint was analysed using a stratified Cox proportional hazards model with treatment group (semaglutide, placebo) as fixed factor. Assuming the same population MACE risk for the semaglutide and placebo groups (i.e., the population hazards ratio \[HR\] equals 1), a total minimum of 122 events were needed in order to have at least 90% power to ascertain that the upper two-sided 95% confidence limit for the HR was less than 1.8.||0.95|0.58|<0.0001
70913374|NCT01720446|141317647|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.0167|TWO_SIDED|95.0|0.58|0.95||The 'p-value' is for the two-sided Wald test of no difference.|Regression, Cox||Semaglutide/Placebo|A post hoc analysis of superiority of semaglutide versus placebo was performed based on the pre-specified Cox proportional hazard analysis using the two-sided Wald test of no difference, with treatment (semaglutide, placebo) as fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||0.95|0.58|0.0167
70913375|NCT01720446|141317648|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.0016|TWO_SIDED|95.0|0.62|0.89|||Regression, Cox||Semaglutide/Placebo|Analysis was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||0.89|0.62|0.0016
70913376|NCT01720446|141317649|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.9181|TWO_SIDED|95.0|0.65|1.48|||Regression, Cox||Semaglutide/Placebo|Analysis for CV death was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||1.48|0.65|0.9181
70913377|NCT01720446|141317649|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.1194|TWO_SIDED|95.0|0.51|1.08|||Regression, Cox||Semaglutide/Placebo|Analysis for non-fatal myocardial infarction was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||1.08|0.51|0.1194
70913378|NCT01720446|141317649|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.0438|TWO_SIDED|95.0|0.38|0.99|||Regression, Cox||Semaglutide/Placebo|Analysis for non-fatal stroke was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||0.99|0.38|0.0438
70913379|NCT01720446|141317649|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.0027|TWO_SIDED|95.0|0.5|0.86|||Regression, Cox||Semaglutide/Placebo|Analysis for revascularisation was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||0.86|0.50|0.0027
70913380|NCT01720446|141317649|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.4914|TWO_SIDED|95.0|0.47|1.44|||Regression, Cox||Semaglutide/Placebo|Analysis for 'unstable angina requiring hospitalisation' was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||1.44|0.47|0.4914
70913381|NCT01720446|141317649|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.5735|TWO_SIDED|95.0|0.77|1.61|||Regression, Cox||Semaglutide/Placcbo|Analysis for hospitalisation for heart failure was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||1.61|0.77|0.5735
70913382|NCT01720446|141317650|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.0292|TWO_SIDED|95.0|0.61|0.97|||Regression, Cox||Semaglutide/Placebo|Analysis for all-cause death, non-fatal MI or non-fatal stroke was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||0.97|0.61|0.0292
70913383|NCT01720446|141317651|SUPERIORITY_OR_OTHER||Treatment difference|-0.66|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.52|||Mixed Models Analysis||Sema 0.5 mg - Placebo 0.5 mg|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-0.52|-0.80|<0.0001
70913384|NCT01720446|141317651|SUPERIORITY_OR_OTHER||Treatment difference|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.19|-0.91|||Mixed Models Analysis||Sema 1.0 mg - Placebo 1.0 mg|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-0.91|-1.19|<0.0001
70913385|NCT01720446|141317652|SUPERIORITY_OR_OTHER||Treatment difference|-0.72|||<|0.0001|TWO_SIDED|95.0|-1.06|-0.38|||Mixed Models Analysis||Sema 0.5 mg - Placebo 0.5 mg|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-0.38|-1.06|<0.0001
70913386|NCT01720446|141317652|SUPERIORITY_OR_OTHER||Treatment difference|-1.22|||<|0.0001|TWO_SIDED|95.0|-1.56|-0.88|||Mixed Models Analysis||Sema 1.0 mg - Placebo 1.0 mg|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-0.88|-1.56|<0.0001
70913387|NCT01720446|141317653|SUPERIORITY_OR_OTHER||Treatment difference|-2.95|||<|0.0001|TWO_SIDED|95.0|-3.47|-2.44|||Mixed Models Analysis||Sema 0.5 mg - Placebo|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-2.44|-3.47|<0.0001
71092865|NCT02469233|141692217|SUPERIORITY||Time by treatment interaction coeff.|-0.71||||0.04|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||BT mean: Treatment effect on change from pre to 6-month follow-up.||||0.04
70913388|NCT01720446|141317653|SUPERIORITY_OR_OTHER||Treatment difference|-4.27|||<|0.0001|TWO_SIDED|95.0|-4.78|-3.75|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-3.75|-4.78|<0.0001
70913389|NCT01720446|141317654|SUPERIORITY_OR_OTHER||Treatment ratio|0.97||||0.0149|TWO_SIDED|95.0|0.95|1.0|||Mixed Models Analysis||Semaglutide 0.5 mg/Placebo 0.5 mg|Analysis for total cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit. The response and its baseline value were log-transformed before analysis.||1.00|0.95|0.0149
70913390|NCT01720446|141317654|SUPERIORITY_OR_OTHER||Treatment ratio|0.99||||0.258|TWO_SIDED|95.0|0.97|1.01|||Mixed Models Analysis||Semaglutide 1.0 mg/Placebo 1.0 mg|Analysis for total cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit. The response and its baseline value were log-transformed before analysis.||1.01|0.97|0.2580
70913391|NCT01720446|141317654|SUPERIORITY_OR_OTHER||Treatment ratio|1.0||||0.8106|TWO_SIDED|95.0|0.99|1.02|||Mixed Models Analysis||Semaglutide 0.5 mg/Placebo 0.5 mg|Analysis for HDL-cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.02|0.99|0.8106
70913392|NCT01720446|141317654|SUPERIORITY_OR_OTHER||Treatment ratio|1.04|||<|0.0001|TWO_SIDED|95.0|1.02|1.06|||Mixed Models Analysis||Semaglutide 1.0 mg/Placebo 1.0 mg|Analysis for HDL-cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.06|1.02|<0.0001
70913393|NCT01720446|141317654|SUPERIORITY_OR_OTHER||Treatment ratio|0.96||||0.0185|TWO_SIDED|95.0|0.93|0.99|||Mixed Models Analysis||Semaglutide 0.5 mg/Placebo 0.5 mg|Analysis for LDL-cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.99|0.93|0.0185
70913394|NCT01720446|141317654|SUPERIORITY_OR_OTHER||Treatment ratio|0.99||||0.5996|TWO_SIDED|95.0|0.96|1.03|||Mixed Models Analysis||Semaglutide 1.0 mg/Placebo 1.0 mg|Analysis for LDL-cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.03|0.96|0.5996
70913395|NCT01720446|141317654|SUPERIORITY_OR_OTHER||Treatment ratio|0.97||||0.1833|TWO_SIDED|95.0|0.93|1.01|||Mixed Models Analysis||Semaglutide 0.5 mg/Placebo 0.5 mg|Analysis for triglycerides was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.01|0.93|0.1833
70913396|NCT01720446|141317654|SUPERIORITY_OR_OTHER||Treatment ratio|0.93||||0.0009|TWO_SIDED|95.0|0.89|0.97|||Mixed Models Analysis||Semaglutide 1.0 mg/Placebo 1.0 mg|Analysis for triglycerides was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.97|0.89|0.0009
70913397|NCT01720446|141317655|SUPERIORITY_OR_OTHER||Treatment ratio|0.78||||0.0003|TWO_SIDED|95.0|0.68|0.89|||Mixed Models Analysis||Sema 0.5 mg / Placebo 0.5 mg|Analysis for urinary albumin to creatinine ration was donne using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit. The response and its baseline value were log-transformed before analysis.||0.89|0.68|0.0003
70913398|NCT01720446|141317655|SUPERIORITY_OR_OTHER||Treatment ratio|0.71|||<|0.0001|TWO_SIDED|95.0|0.62|0.81|||Mixed Models Analysis||Sema 1.0 mg / Placebo 1.0 mg|Analysis for urinary albumin to creatinine ration was donne using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.81|0.62|<0.0001
70913399|NCT01720446|141317656|SUPERIORITY_OR_OTHER||Treatment difference|0.04||||0.9205|TWO_SIDED|95.0|-0.83|0.92|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for diastolic blood pressure was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.92|-0.83|0.9205
70913400|NCT01720446|141317656|SUPERIORITY_OR_OTHER||Treatment difference|0.14||||0.7477|TWO_SIDED|95.0|-0.74|1.03|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for diastolic blood pressure was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.03|-0.74|0.7477
71092866|NCT02469233|141692217|SUPERIORITY||Time by treatment interaction coeff.|-0.31||||0.2|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||BT variability: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.20
71092867|NCT02469233|141692217|SUPERIORITY||Time by treatment interaction coeff.|-0.45||||0.07|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||BT variability: Treatment effect on change from pre to 6-month follow-up.||||0.07
70913401|NCT01720446|141317656|SUPERIORITY_OR_OTHER||Treatment difference|-1.27||||0.0976|TWO_SIDED|95.0|-2.77|0.23|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for systolic blood pressure was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.23|-2.77|0.0976
70913402|NCT01720446|141317656|SUPERIORITY_OR_OTHER||Treatment difference|-2.59||||0.0008|TWO_SIDED|95.0|-4.09|-1.08|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for systolic blood pressure was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-1.08|-4.09|0.0008
70913403|NCT01720446|141317660|SUPERIORITY_OR_OTHER||Treatment difference|0.5||||0.3171|TWO_SIDED|95.0|-0.48|1.47|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for bodily pain was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.47|-0.48|0.3171
70913404|NCT01720446|141317660|SUPERIORITY_OR_OTHER||Treatment difference|1.47||||0.0031|TWO_SIDED|95.0|0.5|2.45|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for bodily pain was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.45|0.50|0.0031
70913405|NCT01720446|141317660|SUPERIORITY_OR_OTHER||Treatment difference|0.87||||0.035|TWO_SIDED|95.0|0.06|1.69|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for general health was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.69|0.06|0.0350
70913406|NCT01720446|141317660|SUPERIORITY_OR_OTHER||Treatment difference|1.42||||0.0007|TWO_SIDED|95.0|0.6|2.24|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for general health was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.24|0.60|0.0007
70913407|NCT01720446|141317660|SUPERIORITY_OR_OTHER||Treatment difference|0.17||||0.7277|TWO_SIDED|95.0|-0.79|1.13|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for mental component summary was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.13|-0.79|0.7277
70913408|NCT01720446|141317660|SUPERIORITY_OR_OTHER||Treatment difference|0.97||||0.0489|TWO_SIDED|95.0|0.0|1.94|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for mental component summary was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.94|0.00|0.0489
70913409|NCT01720446|141317660|SUPERIORITY_OR_OTHER||Treatment Difference|0.61||||0.186|TWO_SIDED|95.0|-0.3|1.53|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for mental health was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.53|-0.30|0.1860
70913410|NCT01720446|141317660|SUPERIORITY_OR_OTHER||Treatment difference|1.39||||0.0029|TWO_SIDED|95.0|0.48|2.31|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for mental health was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.31|0.48|0.0029
70913411|NCT01720446|141317660|SUPERIORITY_OR_OTHER||Treatment difference|0.68||||0.0833|TWO_SIDED|95.0|-0.09|1.45|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for physical component summary was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.45|-0.09|0.0833
70913412|NCT01720446|141317660|SUPERIORITY_OR_OTHER||Treatment difference|1.4||||0.0004|TWO_SIDED|95.0|0.62|2.17|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for physical component summary was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.17|0.62|0.0004
70913413|NCT01720446|141317660|SUPERIORITY_OR_OTHER||Treatment difference|0.8||||0.0799|TWO_SIDED|95.0|-0.1|1.69|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for physical functioning was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.69|-0.10|0.0799
70913414|NCT01720446|141317660|SUPERIORITY_OR_OTHER||Treatment difference|1.5||||0.0011|TWO_SIDED|95.0|0.6|2.4|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for physical functioning was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.40|0.60|0.0011
70913415|NCT01720446|141317660|SUPERIORITY_OR_OTHER||Treatment difference|0.53||||0.3717|TWO_SIDED|95.0|-0.63|1.68|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for role emotional was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.68|-0.63|0.3717
70913416|NCT01720446|141317660|SUPERIORITY_OR_OTHER||Treatment difference|0.94||||0.1136|TWO_SIDED|95.0|-0.22|2.1|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for role emotional was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.10|-0.22|0.1136
70913417|NCT01720446|141317660|SUPERIORITY_OR_OTHER||Treatment difference|0.72||||0.1431|TWO_SIDED|95.0|-0.24|1.67|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for role physical was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.67|-0.24|0.1431
70970666|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|9.5242|STANDARD_ERROR_OF_MEAN|3.7993||0.0152|TWO_SIDED|80.0|4.5949|14.453|||Mixed Models Analysis|||Week 3 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||14.453|4.5949|0.0152
70970667|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|19.9806|STANDARD_ERROR_OF_MEAN|4.1501|<|0.0001|TWO_SIDED|80.0|14.602|25.359|||Mixed Models Analysis|||Week 3 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||25.359|14.602|<.0001
70970668|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7667|STANDARD_ERROR_OF_MEAN|2.9402||0.3516|TWO_SIDED|80.0|-6.59|1.0562|||Mixed Models Analysis|||Week 3 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.0562|-6.590|0.3516
70970669|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0838|STANDARD_ERROR_OF_MEAN|3.2323||0.3448|TWO_SIDED|80.0|-1.116|7.2838|||Mixed Models Analysis|||Week 3 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||7.2838|-1.116|0.3448
70970670|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5882|STANDARD_ERROR_OF_MEAN|4.3902||0.5583|TWO_SIDED|80.0|-8.294|3.1175|||Mixed Models Analysis|||Week 3 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.1175|-8.294|0.5583
70913418|NCT01720446|141317660|SUPERIORITY_OR_OTHER||Treatment difference|1.14||||0.0197|TWO_SIDED|95.0|0.18|2.11|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for role physical was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.11|0.18|0.0197
70913419|NCT01720446|141317660|SUPERIORITY_OR_OTHER||Treatment difference|-0.05||||0.9223|TWO_SIDED|95.0|-1.03|0.93|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for social functioning was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.93|-1.03|0.9223
70913420|NCT01720446|141317660|SUPERIORITY_OR_OTHER||Treatment difference|1.14||||0.0237|TWO_SIDED|95.0|0.15|2.13|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for social functioning was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.13|0.15|0.0237
70913421|NCT01720446|141317660|SUPERIORITY_OR_OTHER||Treatment difference|0.33||||0.4523|TWO_SIDED|95.0|-0.53|1.19|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for vitality was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.19|-0.53|0.4523
70913422|NCT01720446|141317660|SUPERIORITY_OR_OTHER||Treatment difference|1.2||||0.0064|TWO_SIDED|95.0|0.34|2.07|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for vitality was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.07|0.34|0.0064
70913423|NCT01720446|141317661|SUPERIORITY_OR_OTHER||Treatment ratio|0.99||||0.7796|TWO_SIDED|95.0|0.95|1.04|||Mixed Models Analysis||Semaglutide 0.5 mg/Placebo 0.5 mg|Analysis for free fatty acids was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.04|0.95|0.7796
70913424|NCT01720446|141317661|SUPERIORITY_OR_OTHER||Treatment ratio|0.92||||0.0003|TWO_SIDED|95.0|0.88|0.96|||Mixed Models Analysis||Semaglutide 1.0 mg/Placebo 1.0 mg|Analysis for free fatty acids was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.96|0.88|0.0003
70913425|NCT01720446|141317662|SUPERIORITY_OR_OTHER||Treatment difference|2.02|||<|0.0001|TWO_SIDED|95.0|1.07|2.98|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for pulse rate was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.98|1.07|<0.0001
70913426|NCT01720446|141317662|SUPERIORITY_OR_OTHER||Treatment difference|2.47|||<|0.0001|TWO_SIDED|95.0|1.52|3.43|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for pulse rate was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||3.43|1.52|<0.0001
70913427|NCT02175212|141317663|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.88||||0.01|TWO_SIDED|95.0|1.12|3.15|||Regression, Cox|||||3.15|1.12|0.01
70913428|NCT02175212|141317664|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.31||||0.01|TWO_SIDED|95.0|1.23|3.85|||Regression, Cox|||||3.85|1.23|0.01
70913429|NCT02175212|141317665|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.48||||0.009|TWO_SIDED|95.0|1.31|4.68|||Regression, Cox|||||4.68|1.31|0.009
70913430|NCT00606580|141317690|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Chi-squared|||H01: There is no difference in the final clinical cure rate between WR 279,396 and Vehicle AND there is no difference in the final clinical cure rate between Paromomycin Alone and Vehicle.||||0.0001
70913431|NCT00606580|141317690|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||H01: There is no difference in the final clinical cure rate between WR 279,396 and Vehicle AND there is no difference in the final clinical cure rate between Paromomycin Alone and Vehicle.||||<0.0001
70913432|NCT00606580|141317690|NON_INFERIORITY_OR_EQUIVALENCE|Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.871|||||||Chi-squared|||H02: There is no difference in clinical cure between WR 279,396 and Paromomycin Alone. Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||0.871
70913433|NCT00606580|141317691|SUPERIORITY_OR_OTHER|||||||0.0006|||||||Chi-squared|||||||0.0006
70913434|NCT00606580|141317691|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Chi-squared|||||||0.0002
70913435|NCT00606580|141317691|NON_INFERIORITY_OR_EQUIVALENCE|Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.767|||||||Chi-squared|||||||0.767
70913436|NCT00606580|141317692|SUPERIORITY_OR_OTHER|||||||0.33|||||||Log Rank|Mantel-Cox (log-rank) grouped failure time test using proportion re-epithelialized at each of the scheduled assessments through Day 42 without relapse||||||0.330
70913437|NCT00606580|141317692|SUPERIORITY_OR_OTHER|||||||0.275|||||||Log Rank|||||||0.275
70913438|NCT00606580|141317692|NON_INFERIORITY_OR_EQUIVALENCE|The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.83|||||||Log Rank|||||||0.830
70913439|NCT00606580|141317697|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Chi-squared|||||||0.0001
70913440|NCT00606580|141317697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
70913441|NCT00606580|141317697|NON_INFERIORITY_OR_EQUIVALENCE|Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.725|||||||Chi-squared|||||||0.725
70913442|NCT00606580|141317698|SUPERIORITY_OR_OTHER|||||||0.005|||||||Chi-squared|||||||0.005
70913443|NCT00606580|141317698|SUPERIORITY_OR_OTHER|||||||0.005|||||||Chi-squared|||||||0.005
70913444|NCT00606580|141317698|NON_INFERIORITY_OR_EQUIVALENCE|Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||1|||||||Chi-squared|||||||1.000
70913445|NCT00606580|141317699|SUPERIORITY_OR_OTHER|||||||0.003|||||||Chi-squared|||||||0.003
70913446|NCT00606580|141317699|SUPERIORITY_OR_OTHER|||||||0.002|||||||Chi-squared|||||||0.002
70913447|NCT00606580|141317699|NON_INFERIORITY_OR_EQUIVALENCE|Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.893|||||||Chi-squared|||||||0.893
70913448|NCT00606580|141317700|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
70913449|NCT00606580|141317700|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
70913450|NCT00606580|141317700|NON_INFERIORITY_OR_EQUIVALENCE|The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.247|||||||Chi-squared|||||||0.247
70913451|NCT00606580|141317701|SUPERIORITY_OR_OTHER|||||||0.409|||||||Chi-squared|||||||0.409
70913452|NCT00606580|141317701|SUPERIORITY_OR_OTHER|||||||0.651|||||||Chi-squared|||||||0.651
71092868|NCT02469233|141692218|SUPERIORITY||Time by treatment interaction coeff.|-0.33||||0.39|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||WT mean: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.39
70913453|NCT00606580|141317701|NON_INFERIORITY_OR_EQUIVALENCE|The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.701|||||||Chi-squared|||||||0.701
70913454|NCT01859312|141317733|OTHER|||||||0.021|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.021
70913455|NCT01859312|141317735|OTHER|||||||0.027|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.027
70913456|NCT01859312|141317737|OTHER|||||||0.008|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.008
70913457|NCT01859312|141317739|OTHER|||||||0.012|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.012
70913458|NCT01859312|141317741|OTHER|||||||0.157|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.157
70913459|NCT01859312|141317743|OTHER|||||||0.015|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.015
70913460|NCT01859312|141317745|OTHER|||||||0.009|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.009
70913461|NCT01859312|141317747|OTHER|||||||0.008|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.008
70913462|NCT01859312|141317749|OTHER|||||||0.009|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.009
70913463|NCT01859312|141317751|OTHER|||||||0.043|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.043
71092869|NCT02469233|141692218|SUPERIORITY||Time by treatment interaction coeff.|-0.02||||0.96|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||WT mean: Treatment effect on change from pre to 6-month follow-up.||||0.96
71092870|NCT02469233|141692218|SUPERIORITY||Time by treatment interaction coeff.|-0.39||||0.047|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||WT variability: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.047
70913464|NCT01859312|141317753|OTHER|||||||0.024|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.024
70913465|NCT01859312|141317755|OTHER|||||||0.031|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.031
70913466|NCT01859312|141317757|OTHER|||||||0.005|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.005
70913467|NCT01859312|141317759|OTHER|||||||0.004|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.004
70913468|NCT01859312|141317761|OTHER|||||||0.524|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.524
70913469|NCT01859312|141317763|OTHER|||||||0.007|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.|Comparison of hormone levels on conventional glucocorticoid therapy at baseline and following 6 months of CSHI.|||0.007
70913470|NCT01859312|141317765|OTHER|||||||0.084|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.084
70913471|NCT01859312|141317767|OTHER|||||||0.057|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.057
70913472|NCT01859312|141317769|OTHER|||||||0.103|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.103
70913473|NCT01859312|141317771|OTHER|||||||0.07|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.070
70913474|NCT00843193|141317776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.1955|TWO_SIDED|95.0|-0.27|0.06|||ANCOVA|||Comparison between GSK679586 10 mg/kg and Placebo at Week 2||0.06|-0.27|0.1955
70913475|NCT00843193|141317776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.0193|TWO_SIDED|95.0|-0.34|-0.03|||Mixed Model Repeated Measures analysis|||Comparison between GSK679586 10 mg/kg and Placebo at Week 4||-0.03|-0.34|0.0193
70913476|NCT00843193|141317776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.6156|TWO_SIDED|95.0|-0.23|0.14|||Mixed Model Repeated Measures analysis|||Comparison between GSK679586 10 mg/kg and Placebo at Week 8||0.14|-0.23|0.6156
70913477|NCT00843193|141317776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.4672|TWO_SIDED|95.0|-0.31|0.14|||ANCOVA|||Comparison between GSK679586 120 mg/kg and Placebo at Week 12||0.14|-0.31|0.4672
70913478|NCT00843193|141317779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.7693|TWO_SIDED|95.0|-0.08|0.06|||ANCOVA|||Comparison between GSK679586 10 mg/kg and Placebo at Week 2||0.06|-0.08|0.7693
70913479|NCT00843193|141317779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.8987|TWO_SIDED|95.0|-0.08|0.09|||Mixed Model Repeated Measures analysis|||Comparison between GSK679586 10 mg/kg and Placebo at Week 4||0.09|-0.08|0.8987
70970671|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|7.6547|STANDARD_ERROR_OF_MEAN|4.7652||0.1141|TWO_SIDED|80.0|1.4717|13.838|||Mixed Models Analysis|||Week 3 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||13.838|1.4717|0.1141
70913480|NCT00843193|141317779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.4231|TWO_SIDED|95.0|-0.12|0.05|||Mixed Model Repeated Measures analysis|||Comparison between GSK679586 10 mg/kg and Placebo at Week 8||0.05|-0.12|0.4231
70913481|NCT00843193|141317779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.0537|TWO_SIDED|95.0|-0.19|0.0|||Mixed Model Repeated Measures analysis|||Comparison between GSK679586 10 mg/kg and Placebo at Week 12||0.00|-0.19|0.0537
70913482|NCT02512042|141317806|EQUIVALENCE|The limits of each two-sided 95% confidence interval of the treatment difference (test-reference) for mean IOP of both eyes at approximately 8:00 (hours 0, before the morning drop) at the Day 14 visit should be within +/-1.5mm Hg, and should be within +/-1.0mm Hg for majority of time points using the PP population.|Mean Difference (Net)|-0.36|||||TWO_SIDED|95.0|-0.69|-0.03||||||||-0.03|-0.69|
70913483|NCT02512042|141317806|EQUIVALENCE|The limits of each two-sided 95% confidence interval of the treatment difference (test-reference) for mean IOP of both eyes at approximately 8:00 hour on Day 42 should be within +/-1.5mm Hg, and should be within +/- 1.0mm Hg for majority of time points using the PP population.|Mean Difference (Net)|-0.11|||||TWO_SIDED|95.0|-0.43|0.22||||||||0.22|-0.43|
70913484|NCT02512042|141317806|EQUIVALENCE|The limits of each two-sided 95% confidence interval of the treatment difference (test-reference) for mean IOP of both eyes at approximately 10:00 hour on Day 14 should be within +/-1.5mm Hg, and should be within +/-1.0mm Hg for majority of time points using the PP population.|Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-0.71|-0.09||||||||-0.09|-0.71|
71092871|NCT02469233|141692218|SUPERIORITY||Time by treatment interaction coeff.|0.2||||0.3|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||WT variability: Treatment effect on change from pre to 6-month follow-up.||||0.30
71092872|NCT02469233|141692219|SUPERIORITY||Time by treatment interaction coeff.|-4.42||||0.66|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.66
71092873|NCT02469233|141692219|SUPERIORITY||Time by treatment interaction coeff.|-13.34||||0.19|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT mean (min): Treatment effect on change from pre to 6-month follow-up.||||0.19
71092874|NCT02469233|141692219|SUPERIORITY||Time by treatment interaction coeff.|-0.05||||0.77|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT variability (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.77
71092875|NCT02469233|141692219|SUPERIORITY||Time by treatment interaction coeff.|-0.22||||0.2|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT variability (min): Treatment effect on change from pre to 6-month follow-up.||||0.20
71092876|NCT03474107|141692239|SUPERIORITY||Stratified Hazard Ratio|0.702||||0.00142|TWO_SIDED|95.0|0.556|0.886||Stratification factors were ECOG PS, geographic region and liver metastasis. P-value was based on log-rank test. P-value of overall survival is ≤ the predetermined 1-sided significance level of 0.00679 based on the number of observed deaths.|Stratified Log rank||Cox proportional hazards model with treatment, ECOG PS, geographic region and liver metastasis as the explanatory variables.|||0.886|0.556|0.00142
71092877|NCT03474107|141692240|SUPERIORITY||Stratified Hazard Ratio|0.615|||<|1e-05|TWO_SIDED|95.0|0.505|0.748||Stratification factors were ECOG PS, geographic region and liver metastasis. P-value was based on log-rank test. P value of PFS is ≤ the predetermined 1-sided significance level of 0.02189 based on the number of observed PFS events.|Stratified Log Rank||Cox proportional hazards model with treatment, ECOG PS, geographic region and liver metastasis as the explanatory variables.|||0.748|0.505|<0.00001
71092878|NCT03474107|141692241|SUPERIORITY||||||<|0.001||||||"Stratification factors were ECOG PS, Region and Liver Metastasis."|Stratified Cochran-Mantel-Haenszel|||||||<0.001
70913485|NCT02512042|141317806|EQUIVALENCE|The limits of each two-sided 95% confidence interval of the treatment difference (test-reference) for mean IOP of both eyes at approximately 10:00 hour on Day 42 should be within +/-1.5mm Hg, and should be within +/-1.0mm Hg for majority of time points using the PP population|Mean Difference (Net)|-0.19|||||TWO_SIDED|95.0|-0.5|0.13||||||||0.13|-0.50|
70913486|NCT01467700|141317864|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.28||0.518|TWO_SIDED|98.0|-2.9|3.1||P-values were from an MMRM model with baseline\*week, pooled center, week, treatment, baseline, and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||3.1|-2.9|0.518
70913487|NCT01467700|141317864|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.29||0.979|TWO_SIDED|98.0|-0.4|5.7||P-values were from an MMRM model with baseline\*week, pooled center, week, treatment, baseline, and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||5.7|-0.4|0.979
70913488|NCT01467700|141317864|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.29||0.4|TWO_SIDED|99.0|-3.7|3.0||P-values were from an MMRM model with baseline\*week, pooled center, week, treatment, baseline, and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||3.0|-3.7|0.400
70913489|NCT01467700|141317865|SUPERIORITY_OR_OTHER||LS Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|2.22||0.017|TWO_SIDED|98.0|-0.5|9.9||P-values were from an MMRM model with baseline\*week, pooled center, week, treatment, baseline, and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||9.9|-0.5|0.017
70913490|NCT01467700|141317865|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|2.25||0.361|TWO_SIDED|98.0|-4.5|6.1||P-values were from an MMRM model with baseline\*week, pooled center, week, treatment, baseline, and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||6.1|-4.5|0.361
70913491|NCT01467700|141317865|SUPERIORITY_OR_OTHER||LS Mean Difference|6.4|STANDARD_ERROR_OF_MEAN|2.23||0.002|TWO_SIDED|99.0|0.6|12.1||P-values were from an MMRM model with baseline\*week, pooled center, week, treatment, baseline, and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||12.1|0.6|0.002
70913492|NCT03593070|141317899|OTHER|Analyses compared changes in total scores for the MM-CGI from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT).|Slope|0.646|STANDARD_DEVIATION|0.622||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||||||0.001
70913493|NCT03593070|141317900|OTHER||Slope|0.444|STANDARD_DEVIATION|0.105||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||Analyses compared changes in total scores for the CESD from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT).||||0.001
70913494|NCT03593070|141317901|OTHER|Analyses compared changes in total State Trait Anxiety Inventory (STAI) scores from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT).|Slope|0.514|STANDARD_DEVIATION|0.102||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||||||0.001
70913495|NCT03593070|141317902|OTHER|Analyses compared changes in total positive state of mind scale (PSOMS) scores from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT).|Slope|0.653|STANDARD_DEVIATION|0.093||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||||||0.001
70913496|NCT03593070|141317903|OTHER|Analyses compared changes in conflict scores (based on FPCR) from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT)|Slope|0.609|STANDARD_DEVIATION|0.07||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||||||0.001
70913497|NCT03593070|141317904|OTHER|Analyses compared changes in total scores for satisfaction with care measure (FPCT) from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT)|Slope|0.731|STANDARD_DEVIATION|0.074||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||||||0.001
70913498|NCT03593070|141317905|OTHER|Analyses compared changes in total Family Knowledge of Alzheimer's Test (FKAT) scores from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT)|Slope|0.687|STANDARD_DEVIATION|0.084||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||||||0.001
70913499|NCT03593070|141317906|OTHER||Slope|0.527|STANDARD_DEVIATION|0.088||0.001|TWO_SIDED|||||A prior alpha=0.05.|Regression, Linear|||Analyses compared changes in caregiver sense of loss, guilt, and role captivity scores from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT). This measure uses 51 items of the FPCR measure.||||0.001
70913500|NCT01656304|141317912|SUPERIORITY_OR_OTHER||Rate|0.333|STANDARD_ERROR_OF_MEAN|0.1217|||TWO_SIDED|80.0|0.2|0.5||||||||.50|.20|
70913501|NCT02908620|141317918|SUPERIORITY||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|2.74||0.322|TWO_SIDED|95.0|-3.06|8.69|||ANOVA||Least squares mean (marginal mean)|||8.69|-3.06|0.322
70913502|NCT02908620|141317919|SUPERIORITY||Mean Difference (Final Values)|-8.7|STANDARD_ERROR_OF_MEAN|5.48||0.134|TWO_SIDED|95.0|-20.38|2.99|||ANOVA||Least squares mean (marginal mean)|||2.99|-20.38|0.134
70913503|NCT02908620|141317920|SUPERIORITY||Mean Difference (Final Values)|4.1|STANDARD_ERROR_OF_MEAN|4.92||0.442|TWO_SIDED|95.0|-6.48|14.62|||ANOVA||Least squares mean (marginal mean)|||14.62|-6.48|0.442
70913504|NCT02908620|141317921|SUPERIORITY||Mean Difference (Final Values)|6.8|STANDARD_ERROR_OF_MEAN|4.78||0.172|TWO_SIDED|95.0|-3.27|16.9|||ANOVA||Least squares mean (marginal mean)|||16.90|-3.27|0.172
70913505|NCT04548622|141317928|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
70913506|NCT04548622|141317929|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
70913507|NCT04548622|141317930|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
70913508|NCT00762463|141317956|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|LS mean difference calculated as LS mean change for Celecoxib 200 mg once daily minus LS mean change for Diclofenac SR 75 mg once daily. Non-inferiority was declared if the upper bound of the 95% confidence interval was \<10 mm.|LS Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|2.79||0.0085|TWO_SIDED|95.0|-2.2|8.8|||ANCOVA|Analysis of covariance (ANCOVA); factors: treatment group and study center; covariate: baseline Patient's Assessment of Global Pain Intensity score.||"Null hypothesis: Least Squares (LS) mean difference between Celecoxib 200 mg once daily versus Diclofenac SR 75 mg once daily on change in Global Pain Intensity from baseline to Week 6 was at least 10 mm. Corresponding alternative hypothesis: This difference was \<10 mm.~For the non-inferiority test, power was 80% and significance level was 0.025 (1-sided)."||8.8|-2.2|0.0085
70913509|NCT00762463|141317958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.5||0.7849|TWO_SIDED|95.0|-5.6|4.2|||ANCOVA|Change from baseline analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||4.2|-5.6|0.7849
70913510|NCT00762463|141317958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|2.62||0.3223|TWO_SIDED|95.0|-2.6|7.8|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||7.8|-2.6|0.3223
70913511|NCT00762463|141317960|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.8938|TWO_SIDED|95.0|-0.15|0.17|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.17|-0.15|0.8938
70913512|NCT00762463|141317960|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.08||0.0426|TWO_SIDED|95.0|0.01|0.31|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.31|0.01|0.0426
70913513|NCT00762463|141317960|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.09||0.1502|TWO_SIDED|95.0|-0.05|0.29|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.29|-0.05|0.1502
70913514|NCT00762463|141317962|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.5945|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.1|-0.2|0.5945
70913515|NCT00762463|141317962|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.3427|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.2|-0.1|0.3427
70913516|NCT00762463|141317962|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.6522|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.2|-0.1|0.6522
70913517|NCT00762463|141317964|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.18||0.9358|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.4|-0.3|0.9358
70913518|NCT00762463|141317964|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.5916|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.5|-0.3|0.5916
70913519|NCT00762463|141317964|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.179|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.7|-0.1|0.1790
70913520|NCT00762463|141317966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.6335|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.5|-0.3|0.6335
70913521|NCT00762463|141317966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.21||0.2729|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.6|-0.2|0.2729
70913522|NCT00762463|141317966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1559|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.8|-0.1|0.1559
70913523|NCT00762463|141317969|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.3|STANDARD_ERROR_OF_MEAN|2.67||0.1111|TWO_SIDED|95.0|-1.0|9.5|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||9.5|-1.0|0.1111
70913524|NCT00762463|141317969|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|2.74||0.3574|TWO_SIDED|95.0|-2.9|7.9|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||7.9|-2.9|0.3574
70913525|NCT00762463|141317969|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|2.76||0.1464|TWO_SIDED|95.0|-1.4|9.5|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||9.5|-1.4|0.1464
70913526|NCT00762463|141317971|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.87||0.9641|TWO_SIDED|95.0|-1.7|1.8|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||1.8|-1.7|0.9641
71092879|NCT03474107|141692242|SUPERIORITY||||||<|0.001||||||Stratification factors were ECOG PS, Region and Liver Metastasis.|Stratified Cochran-Mantel-Haenszel|||||||<0.001
70913527|NCT00762463|141317971|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.98||0.7749|TWO_SIDED|95.0|-1.6|2.2|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||2.2|-1.6|0.7749
70913528|NCT00762463|141317971|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.95||0.7529|TWO_SIDED|95.0|-1.6|2.2|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||2.2|-1.6|0.7529
70913529|NCT00762463|141317973|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.11||0.878|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.2|-0.2|0.8780
70913530|NCT00762463|141317973|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.13||0.2202|TWO_SIDED|95.0|-0.1|0.4|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.4|-0.1|0.2202
70913531|NCT00762463|141317973|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.534|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.4|-0.2|0.5340
70913532|NCT00762463|141317975|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.81||0.7003|TWO_SIDED|95.0|-4.3|2.9|||ANCOVA|Change from baseline analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||2.9|-4.3|0.7003
70913533|NCT00762463|141317977|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|2.221||0.5183|TWO_SIDED|95.0|-5.82|2.94|||ANCOVA|Change from baseline analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||2.94|-5.82|0.5183
70913534|NCT01306331|141317982|NON_INFERIORITY|If the upper bound for the confidence interval of the difference was \< 5.5, then the null hypothesis would be rejected.|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-2.2|3.2||||||The primary hypothesis test was performed using 95% confidence interval for the difference in cumulative pregnancy rates between the treatment arms. If the upper bound for the confidence interval of the difference was \< 5.5, then the null hypothesis would be rejected.||3.2|-2.2|
71153802|NCT00488683|141800057|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y||||
71153803|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.83||||0.001||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A||||0.001
71153804|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.14||||0.57||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A||||0.57
70913535|NCT01677936|141318004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.0|||=|0.024||||||Compared to snacks, raisins reduced percent post-prandial glucose levels by 23%, which met the a priori threshold for statistical significance.|t-test, 2 sided|||||||=0.024
70913536|NCT01677936|141318005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.7|||=|0.035||||||Compared with snacks, the 8.8 mmHg reduction with raisins met the a priori threshold for statistical significance.|t-test, 2 sided|||||||=0.035
70913537|NCT04358549|141318006|SUPERIORITY||Median Difference (Final Values)|14.0||||0.0415|TWO_SIDED|90.0|||||Log Rank|||||||0.0415
70913538|NCT04358549|141318007|SUPERIORITY||Odds Ratio (OR)|0.653|||||TWO_SIDED|90.0|0.19|2.24||||||||2.240|0.190|
70913539|NCT04358549|141318008|SUPERIORITY||Median Difference (Final Values)|3.0||||0.9879|TWO_SIDED|90.0|||||Log Rank|||||||0.9879
70913540|NCT02085356|141318016|OTHER||Odds Ratio (OR)|1.12|||||TWO_SIDED|||||||||||||
70913541|NCT02085356|141318017|OTHER||Odds Ratio (OR)|0.32|||||TWO_SIDED|||||||||||||
70913542|NCT02085356|141318018|OTHER|||||||0.605|||||||Mixed Models Analysis|||||||0.605
70913543|NCT02085356|141318019|OTHER|||||||0.902|||||||Chi-squared|||Attendance records could not be retrieved for most participants. However, this analysis was still conducted among those participants who had data.||||0.902
70913544|NCT02085356|141318020|OTHER|||||||0.869|||||||Mixed Models Analysis|||||||0.869
70913545|NCT02085356|141318020|OTHER||Odds Ratio (OR)|0.32||||0.982|TWO_SIDED||||||Mixed Models Analysis|||||||0.982
70913546|NCT00157014|141318046|SUPERIORITY_OR_OTHER|||||||0.4725||95.0||||No adjustments for multiple comparisons were performed.|Wilcoxon (Mann-Whitney)|||||||0.4725
70913547|NCT00157014|141318057|SUPERIORITY_OR_OTHER|||||||0.8373||95.0||||No adjustments for multiple comparisons were performed.|Wilcoxon (Mann-Whitney)|||||||0.8373
70913548|NCT01257503|141318073|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Regression, Linear|generalized estimating equations used to account for multiple doses in same participant||change in runny nose||||.86
70913549|NCT01257503|141318073|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||Regression, Linear|generalized estimating equations used to account for multiple doses in single participant||change in sneeze||||.89
71153805|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.65||||0.001||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C||||0.001
71153806|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.31||||0.11||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C||||0.11
71153807|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.02||||0.94||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.94
70913550|NCT01257503|141318073|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||Regression, Linear|generalized estimating equations used to account for multiple doses in single participant||change in cough||||.45
70913551|NCT01257503|141318073|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||Regression, Linear|generalized estimating equations used to account for multiple doses in single participant||change in congestion||||.82
70913552|NCT01257503|141318074|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Regression, Linear|Generalized estimating equations used to account for multiple doses in single participant.||change in irritability||||.61
70913553|NCT01257503|141318074|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Regression, Linear|Generalized estimating equations used to account for multiple doses in single participant.||change in lethargy||||.97
70913554|NCT01257503|141318074|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||Regression, Linear|Generalized estimating equations used to account for multiple doses in single participant.||change in fussiness||||.79
70913555|NCT01257503|141318074|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||Regression, Linear|Generalized estimating equations used to account for multiple doses in single participant.||change in appetite||||.81
70913556|NCT01257503|141318075|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||functional status day 1||||.16
70913557|NCT01257503|141318075|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||functional status day 2||||.70
70913558|NCT01257503|141318075|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||functional status day 3||||.77
70913559|NCT01257503|141318075|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||functional status at 7-10 day follow-up||||.41
70913560|NCT01257503|141318076|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||health status day 1||||.10
70913561|NCT01257503|141318076|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||health status day 2||||.28
70913562|NCT01257503|141318076|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||health status day 3||||.26
70913563|NCT01257503|141318076|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||health status at follow-up||||.88
70913564|NCT01257503|141318077|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||cold score day 1 assessment 1||||.02
70913565|NCT01257503|141318077|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||cold score day 1 assessment 2||||.01
70913566|NCT01257503|141318077|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||day 2 assessment 1||||.25
70913567|NCT01257503|141318077|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||cold score day 2 assessment 2||||.15
70913568|NCT01257503|141318077|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||cold score day 3 assessment 1||||.88
70913569|NCT01257503|141318077|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||cold score day 3 assessment 2||||.35
70913570|NCT01257503|141318077|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||cold score at 7-10 day follow-up||||.36
70913571|NCT02380742|141318107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.87|STANDARD_ERROR_OF_MEAN|0.47||0.02|TWO_SIDED||||||ANCOVA|||The null hypothesis was that patients' pain scores at removal were the same between the lidocaine and placebo groups after controlling for baseline pain.||||.02
70913572|NCT02380742|141318108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.96|STANDARD_ERROR_OF_MEAN|0.87||0.03|TWO_SIDED||||||ANCOVA|||The null hypothesis was that patients' pain scores at removal were the same between the lidocaine and placebo groups after controlling for investigator training and pessary type.||||.03
70913573|NCT02380742|141318109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.811|STANDARD_ERROR_OF_MEAN|0.83||0.03|TWO_SIDED||||||ANCOVA|||The null hypothesis was that patients' pain scores at removal were the same between the lidocaine and placebo groups after controlling for baseline pain and patient age.||||.03
70913574|NCT02380742|141318110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|0.63||0.09|TWO_SIDED||||||ANCOVA|||The null hypothesis was that patients' pain scores at insertion were the same between the lidocaine and placebo groups after controlling for baseline pain.||||.09
70913575|NCT00151996|141318111|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Change from baseline in ADHD-RS-IV total score||||<0.0001
70913576|NCT00151996|141318111|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Change from baseline in ADHD-RS-IV total score||||<0.0001
70913577|NCT00151996|141318113|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Change from baseline in CPRS-R total score||||<0.0001
70913578|NCT00151996|141318113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0|||||t-test, 2 sided|||Change from baseline in CPRS-R total score||||0.0002
70913579|NCT00151996|141318115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7004||95.0|||||t-test, 2 sided|||Change in physical summary score||||0.7004
70913580|NCT00151996|141318115|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Change in psychosocial summary score||||<0.0001
70913581|NCT00151996|141318115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9257||95.0|||||t-test, 2 sided|||Change in physical summary score||||0.9257
70913582|NCT00151996|141318115|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Change in psychosocial summary score||||<0.0001
70913583|NCT03686813|141318138|OTHER|||||||0.317|||||||McNemar|||||||0.317
70913584|NCT03686813|141318139|OTHER|||||||0.317|||||||McNemar|||||||0.317
70913585|NCT03686813|141318140|OTHER||||||>|0.999|||||||McNemar|||||||>0.999
70913586|NCT03686813|141318141|OTHER|||||||0.18|||||||McNemar|||||||0.18
70913587|NCT03686813|141318142|OTHER|||||||0.29|||||||McNemar|||||||0.29
70913588|NCT02131324|141318143|EQUIVALENCE|Two-sided hypothesis testing was conducted for all the tests. Resulting p-values less than 0.05 were considered statistically significant unless noted otherwise. No adjustments of p values were made for multiple comparisons.||||||0.086|||||||ANOVA|||Two-sided hypothesis testing was conducted for all the tests. Resulting p-values less than 0.05 were considered statistically significant unless noted otherwise. No adjustments of p values were made for multiple comparisons.||||0.086
70913589|NCT00420316|141318160|SUPERIORITY_OR_OTHER||Percent reduction|34.3||||0.691|TWO_SIDED|95.0|-348.7|88.9|||Fisher Exact|||Vaccine efficacy with respect to any rotavirus gastroenteritis (RV GE) caused by the circulating wild-type rotavirus strain. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.||88.9|-348.7|0.691
70913590|NCT00420316|141318161|SUPERIORITY_OR_OTHER||Percent reduction|50.7||||0.551|TWO_SIDED|95.0|-3769.6|99.4|||Fisher Exact|||Vaccine efficacy with respect to severe rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain was assessed. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who have received placebo.||99.4|-3769.6|0.551
70913591|NCT00420316|141318163|SUPERIORITY_OR_OTHER||Percent reduction|100.0||||0.33|TWO_SIDED|95.0|-1822.5|100.0|||Fisher Exact|||Vaccine efficacy with respect to severe rotavirus gastroenteritis (RVGE) caused by the wild-type rotavirus strain of serotype G1. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.||100|-1822.5|0.33
70913592|NCT00420316|141318164|SUPERIORITY_OR_OTHER||Percent reduction|-97.2||||1|TWO_SIDED|95.0|-9610.8|80.5|||Fisher Exact|||Vaccine efficacy with respect to any rotavirus gastroenteritis (RVGE) caused by the wild-type rotavirus strain of non-G1 serotype. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.||80.5|-9610.8|1
70913593|NCT00420316|141318165|SUPERIORITY_OR_OTHER||Percent reduction|0.0||||1|TWO_SIDED|95.0|0.0|98.7|||Fisher Exact|||Vaccine efficacy with respect to severe rotavirus gastroenteritis (RVGE) caused by the wild-type rotavirus strain of non-G1 serotype was assessed. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.||98.7|0|1
70913594|NCT00420316|141318166|SUPERIORITY_OR_OTHER||Percent reduction|-23.2||||0.817|TWO_SIDED|95.0|-287.7|54.8|||Fisher Exact|||Vaccine efficacy with respect to severe gastroenteritis (GE) was assessed. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.||54.8|-287.7|0.817
70913595|NCT05419557|141318196|SUPERIORITY||Odds Ratio (OR)|8.5||||0.02|TWO_SIDED|95.0|1.3|54.6|||Regression, Logistic|||||54.6|1.3|0.02
70913596|NCT05419557|141318197|SUPERIORITY||Odds Ratio (OR)|9.98||||0.015|TWO_SIDED|95.0|1.55|64.25|||Regression, Logistic|||||64.25|1.55|0.015
70913597|NCT04304534|141318215|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.052|||=|0.8439|TWO_SIDED|90.0|0.687|1.612|||Log Rank|||Comparison of the Asundexian 20 mg group and 50 mg group versus Placebo group||1.612|0.687|= 0.8439
70913598|NCT04304534|141318215|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.096|||=|0.7562|TWO_SIDED|90.0|0.674|1.781|||Log Rank|||Comparison of the Asundexian 20 mg group versus Placebo group||1.781|0.674|= 0.7562
70913599|NCT04304534|141318215|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.008|||=|0.978|TWO_SIDED|90.0|0.614|1.656|||Log Rank|||Comparison of the Asundexian 50 mg group versus Placebo group||1.656|0.614|= 0.978
70913600|NCT04304534|141318216|OTHER|HR was only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups.|Hazard Ratio (HR)|0.98|||=|0.9158|TWO_SIDED|90.0|0.713|1.347|||Log Rank|||Comparison of the Pooled Asundexian group versus Placebo group||1.347|0.713|= 0.9158
70913601|NCT04304534|141318216|OTHER|HR was only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups.|Hazard Ratio (HR)|0.867|||=|0.5633|TWO_SIDED|90.0|0.577|1.302|||Log Rank|||Comparison of the Asundexian 10 mg group versus Placebo group||1.302|0.577|= 0.5633
70913602|NCT04304534|141318216|OTHER|HR was only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups.|Hazard Ratio (HR)|0.875|||=|0.584|TWO_SIDED|90.0|0.587|1.306|||Log Rank|||Comparison of the Asundexian 20 mg group versus Placebo group||1.306|0.587|= 0.584
70913603|NCT04304534|141318216|OTHER|HR was only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups.|Hazard Ratio (HR)|1.202|||=|0.417|TWO_SIDED|90.0|0.828|1.747|||Log Rank|||Comparison of the Asundexian 50 mg group versus Placebo group||1.747|0.828|= 0.417
70913604|NCT04304534|141318217|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.275|||||TWO_SIDED|90.0|0.322|5.05||||||Comparison of the Asundexian 20 mg group and Asundexian 50 mg group versus Placebo group||5.050|0.322|
70913605|NCT04304534|141318217|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.991|||||TWO_SIDED|90.0|0.479|8.273||||||Comparison of the Asundexian 50 mg group versus Placebo group||8.273|0.479|
70913606|NCT04304534|141318218|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.125|||||TWO_SIDED|90.0|0.696|1.819||||||Comparison of the Asundexian 20 mg group and Asundexian 50 mg versus Placebo group||1.819|0.696|
70913607|NCT04304534|141318218|OTHER||Cox Proportional Hazard|1.181|||||TWO_SIDED|90.0|0.686|2.031||||||Comparison of the Asundexian 20 mg group versus Placebo group||2.031|0.686|
70913608|NCT04304534|141318218|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.07|||||TWO_SIDED|90.0|0.613|1.866||||||Comparison of the Asundexian 50 mg group versus Placebo group||1.866|0.613|
70913609|NCT04304534|141318221|OTHER|For all-cause mortality there is no competing event.|Cox Proportional Hazard|1.266|||=|0.6016|TWO_SIDED|90.0|0.603|2.658|||Log Rank|||Comparison of the Asundexian 20 mg group and Asundexian 50 mg group versus Placebo group||2.658|0.603|= 0.6016
70913610|NCT04304534|141318221|OTHER||Cox Proportional Hazard|0.996|||=|0.9945|TWO_SIDED|90.0|0.414|2.401|||Log Rank|||Comparison of the Asundexian 20 mg group versus Placebo group||2.401|0.414|= 0.9945
70913611|NCT04304534|141318221|OTHER||Cox Proportional Hazard|1.506|||=|0.4085|TWO_SIDED|90.0|0.667|3.405|||Log Rank|||Comparison of the Asundexian 50 mg group versus Placebo group||3.405|0.667|= 0.4085
70913612|NCT00667693|141318254|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35|||<|0.001|TWO_SIDED|95.0|0.23|0.55|||Regression, Cox|||||0.55|0.23|<0.001
70913613|NCT02020018|141318259|SUPERIORITY|||||||0.55|||||||Fisher Exact|||||||0.55
70913614|NCT04044664|141318262|OTHER|||||||0.1728|||||||t-test, 1 sided|||CAPS-5 Total Score||||0.1728
70913615|NCT04044664|141318262|OTHER|||||||0.0962|||||||t-test, 1 sided|||Cognition and Mood sub-score||||0.0962
70913616|NCT04044664|141318262|OTHER|||||||0.0191|||||||t-test, 1 sided|||Arousal and Reactivity sub-score||||0.0191
70913617|NCT04044664|141318268|OTHER|||||||0.0452|||||||t-test, 1 sided|||||||0.0452
70913618|NCT04044664|141318268|OTHER|||||||0.0614|||||||t-test, 1 sided|||||||0.0614
70913619|NCT04044664|141318269|OTHER|||||||0.0182|||||||t-test, 1 sided|||greater than or equal to 30% decrease from baseline||||0.0182
70913620|NCT04044664|141318269|OTHER|||||||0.0705|||||||t-test, 1 sided|||greater than or equal to 50% decrease from baseline||||0.0705
70913621|NCT03736785|141318273|EQUIVALENCE|Equivalence margin is zero.|||||<|0.001||||||P-value reported is within group comparison between Week 32 and baseline.|Mixed Models Analysis|||||||<0.001
70913622|NCT03736785|141318273|EQUIVALENCE|Equivalence margin is zero.|||||<|0.001||||||P-value reported is within group comparison between Week 32 and baseline.|Mixed Models Analysis|||||||<0.001
70913623|NCT03736785|141318273|EQUIVALENCE|Equivalence margin is zero.|||||<|0.001||||||P-value reported is within group comparison between Week 32 and baseline.|Mixed Models Analysis|||||||<0.001
70913624|NCT03736785|141318274|NON_INFERIORITY|Non-inferiority margin is 0.4%|LSMean Difference|0.08|||||TWO_SIDED|90.0|-0.11|0.28|||Mixed Models Analysis|||||0.28|-0.11|
70913625|NCT03736785|141318274|NON_INFERIORITY|Non-inferiority margin is 0.4%|LSMean Difference|0.09|||||TWO_SIDED|90.0|-0.1|0.29|||Mixed Models Analysis|||||0.29|-0.10|
70913626|NCT00300456|141318287|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect a 24% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%||||<0.001
70913627|NCT00300456|141318287|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect 24% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%||||<0.001
70913628|NCT00300456|141318288|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide 98% power to detect a 9% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
70913629|NCT00300456|141318288|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide 98% power to detect a 9% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
70913630|NCT00300456|141318289|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect an 11% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
70913631|NCT00300456|141318289|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect an 11% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
70913632|NCT04511650|141318314|SUPERIORITY|||||||0.4795|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by disease severity.||Pooled Razuprotafib comparison to Placebo. All results are summarized descriptively by treatment arm and expressed as proportions, along with corresponding 95% confidence intervals (CIs) of the difference between response rates, and p-values.||||0.4795
70913633|NCT00964119|141318325|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|90.0||||P-value \< .05 is the computed p-value for this measurement.|t-test, 2 sided|||PI and lead author left the institution before publishing data. Study has been closed and data files archived.||||<.05
70913634|NCT03727854|141318326|SUPERIORITY|||||||0.933|||||||t-test, 2 sided|||||||0.933
70913635|NCT03727854|141318327|SUPERIORITY|||||||0.971|||||||t-test, 2 sided|||||||0.971
70913636|NCT03727854|141318328|SUPERIORITY|||||||0.608|||||||t-test, 2 sided|||||||0.608
70913637|NCT03727854|141318329|SUPERIORITY|||||||0.617|||||||t-test, 2 sided|||||||0.617
70913638|NCT03727854|141318330|SUPERIORITY|||||||0.823|||||||t-test, 2 sided|||||||0.823
70913639|NCT03727854|141318331|SUPERIORITY|||||||0.74|||||||t-test, 2 sided|||||||0.740
70913640|NCT03727854|141318332|SUPERIORITY|||||||0.551|||||||t-test, 2 sided|||||||0.551
70913641|NCT03727854|141318333|SUPERIORITY|||||||0.652|||||||t-test, 2 sided|||||||0.652
70913642|NCT03727854|141318334|SUPERIORITY|||||||0.639|||||||t-test, 2 sided|||||||0.639
70913643|NCT01078246|141318335|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|2.282||||0.002|TWO_SIDED|95.0|1.344|3.875|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||AIDS-defining malignancies||3.875|1.344|0.002
70913644|NCT01078246|141318335|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.84|||<|0.05|TWO_SIDED|95.0|1.621|4.977|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||AIDS-defining malignancies||4.977|1.621|<0.05
70913645|NCT01078246|141318335|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.871||||0.005|TWO_SIDED|95.0|1.207|2.899|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||AIDS-defining malignancies||2.899|1.207|0.005
70913646|NCT01078246|141318335|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.879||||0.004|TWO_SIDED|95.0|1.227|2.879|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||AIDS-defining malignancies||2.879|1.227|0.004
70913647|NCT01078246|141318335|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.943||||0.008|TWO_SIDED|95.0|1.191|3.168|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||Non-AIDS-defining malignancies||3.168|1.191|0.008
70913648|NCT01078246|141318335|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.459||||0.001|TWO_SIDED|95.0|1.454|4.159|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||Non-AIDS-defining malignancies||4.159|1.454|0.001
70913649|NCT01078246|141318335|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.776||||0.004|TWO_SIDED|95.0|1.199|2.631|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||Non-AIDS-defining malignancies||2.631|1.199|0.004
70913650|NCT01078246|141318335|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.86||||0.001|TWO_SIDED|95.0|1.274|2.717|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||Non-AIDS-defining malignancies||2.717|1.274|0.001
70913651|NCT01078246|141318336|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.807||||0.255|TWO_SIDED|95.0|0.557|1.168|||Poisson regression|The analysis included adjustments for raltegravir exposure, propensity score, treatment regimen (1st, 2nd, 3rd+), and Hepatitis B/C status.||||1.168|0.557|0.255
70913652|NCT01078246|141318336|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.907||||0.646|TWO_SIDED|95.0|0.597|1.376|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, treatment regimen (1st, 2nd, 3rd+), and Hepatitis B/C status.||||1.376|0.597|0.646
70913653|NCT01078246|141318336|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.268||||0.182|TWO_SIDED|95.0|0.895|1.795|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, treatment regimen (1st, 2nd, 3rd+), and Hepatitis B/C status.||||1.795|0.895|0.182
70970672|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5882|STANDARD_ERROR_OF_MEAN|0.1903||0.0034|TWO_SIDED|80.0|-0.8356|-0.3408|||Mixed Models Analysis|||Week 3 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.3408|-0.8356|0.0034
70970673|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1722|STANDARD_ERROR_OF_MEAN|0.2064||0.4083|TWO_SIDED|80.0|-0.4403|0.09599|||Mixed Models Analysis|||Week 3 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.09599|-0.4403|0.4083
70913654|NCT01078246|141318336|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.257||||0.188|TWO_SIDED|95.0|0.894|1.768|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, treatment regimen (1st, 2nd, 3rd+), and Hepatitis B/C status.||||1.768|0.894|0.188
70913655|NCT01078246|141318337|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.016||||0.897|TWO_SIDED|95.0|0.796|1.297|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.297|0.796|0.897
70913656|NCT01078246|141318337|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.287||||0.07|TWO_SIDED|95.0|0.98|1.69|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.690|0.980|0.070
70913657|NCT01078246|141318337|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.067||||0.575|TWO_SIDED|95.0|0.85|1.339|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.339|0.850|0.575
70913658|NCT01078246|141318337|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.057||||0.626|TWO_SIDED|95.0|0.847|1.319|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.319|0.847|0.626
70913659|NCT01078246|141318339|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.389|||<|0.0001|TWO_SIDED|95.0|0.274|0.551|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||0.551|0.274|<0.0001
70913660|NCT01078246|141318339|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.471|||<|0.05|TWO_SIDED|95.0|0.314|0.707|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||0.707|0.314|<0.05
70913661|NCT01078246|141318339|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.65||||0.015|TWO_SIDED|95.0|1.102|2.47|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||2.470|1.102|0.015
70913662|NCT01078246|141318339|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.622||||0.018|TWO_SIDED|95.0|1.085|2.425|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||2.425|1.085|0.018
70913663|NCT01078246|141318340|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.75||||0.423|TWO_SIDED|95.0|0.37|1.517|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.517|0.370|0.423
70913664|NCT01078246|141318340|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.208||||0.631|TWO_SIDED|95.0|0.559|2.612|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||2.612|0.559|0.631
70913665|NCT01078246|141318340|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.845||||0.592|TWO_SIDED|95.0|0.458|1.561|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.561|0.458|0.592
70913666|NCT01078246|141318340|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.022||||0.943|TWO_SIDED|95.0|0.565|1.85|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.850|0.565|0.943
70913667|NCT01078246|141318341|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.708||||0.109|TWO_SIDED|95.0|0.464|1.08|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.080|0.464|0.109
70913668|NCT01078246|141318341|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.794||||0.356|TWO_SIDED|95.0|0.486|1.296|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.296|0.486|0.356
70913669|NCT01078246|141318341|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.556||||0.039|TWO_SIDED|95.0|1.022|2.37|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||2.370|1.022|0.039
70913670|NCT01078246|141318341|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.564||||0.033|TWO_SIDED|95.0|1.036|2.361|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||2.361|1.036|0.033
70913671|NCT01078246|141318341|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.72||||0.125|TWO_SIDED|95.0|0.861|3.437|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, and propensity score, and was stratified by the 1st treatment regimen.||||3.437|0.861|0.125
70913672|NCT01078246|141318341|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.056||||0.881|TWO_SIDED|95.0|0.517|2.155|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, and propensity score, and was stratified by the 2nd treatment regimen.||||2.155|0.517|0.881
70913673|NCT01078246|141318341|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.077||||0.107|TWO_SIDED|95.0|0.854|5.05|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, and propensity score, and was stratified by the 3rd+ treatment regimen.||||5.05|0.854|0.107
70913674|NCT01081145|141318342|SUPERIORITY_OR_OTHER_LEGACY||Difference in treatment failures|-15.6||||0.006|TWO_SIDED|95.0|-26.6|-4.5|||Cochran-Mantel-Haenszel|||||-4.5|-26.6|0.006
70913675|NCT01081145|141318343|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||Log Rank|||||||0.003
70913676|NCT01081145|141318344|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-6.24|||<|0.001|TWO_SIDED|95.0|-9.01|-3.48||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-3.48|-9.01|<0.001
70913677|NCT01081145|141318345|SUPERIORITY_OR_OTHER_LEGACY||Difference in percent of subjects|17.5||||0.001|TWO_SIDED|95.0|6.6|28.5||Nominal p-value uncorrected for multiplicity.|Cochran-Mantel-Haenszel|||||28.5|6.6|0.001
70913678|NCT01081145|141318346|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.06||||0.118|TWO_SIDED|95.0|-0.14|0.02||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.02|-0.14|0.118
70913679|NCT01081145|141318349|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Nominal p-value uncorrected for multiplicity.|t-test, 2 sided|||||||<0.001
70913680|NCT01081145|141318353|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Nominal p-value uncorrected for multiplicity.|t-test, 2 sided|||||||<0.001
70913681|NCT02197234|141318356|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CIs being within 70% to 143%.|Geometric mean ratio|77.08|||||TWO_SIDED|90.0|63.41|93.7|||||Simvastatin + AZD9291 / Simvastatin alone. Based on linear mixed-effects model with treatment as fixed effect and patient as a random effect.|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AUC9291 being within 70-143% was 90% (95% for each parameter). Within patient CV assumed to be 45%. No change in exposure was also assumed.||93.70|63.41|
70913682|NCT02197234|141318357|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CIs being within 70% to 143%.|Geometric mean ratio|91.46|||||TWO_SIDED|90.0|77.16|108.41|||||Simvastatin + AZD9291 / Simvastatin alone. Based on linear mixed-effects model with treatment as fixed effect and patient as a random effect.|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AUC9291 being within 70-143% was 90% (95% for each parameter). Within patient CV assumed to be 45%. No change in exposure was also assumed.||108.41|77.16|
70913683|NCT05826431|141318367|OTHER||Mean Difference (Final Values)|18.65||||0.153|TWO_SIDED||||||Paired samples t-test|||Study analyses were conducted using IBM SPSS Statistics Version 29. Frequencies and descriptive data were tabulated to describe the sample and quantify device use, satisfaction, and perceived impact. Qualitative responses regarding usability and feasibility were summarized based on the themes of the responses.||||0.153
70913684|NCT05826431|141318368|OTHER||Mean Difference (Final Values)|0.61||||0.103|TWO_SIDED||||||Paired samples t-test|||||||0.103
70913685|NCT05826431|141318370|OTHER|Single group, frequencies, and descriptive data|Mean Difference (Final Values)|4.22||||0.083|TWO_SIDED||||||Paired samples t-test|||||||.083
70913686|NCT05826431|141318371|OTHER||Mean Difference (Final Values)|-0.26||||441|TWO_SIDED||||||Paired samples t-test|||||||0441
70913687|NCT05826431|141318372|OTHER||Mean Difference (Final Values)|2.61||||0.095|TWO_SIDED||||||Paired samples t-test|||||||0.095
70913688|NCT05826431|141318373|OTHER||Mean Difference (Final Values)|0.03||||0.487|TWO_SIDED||||||Paired samples t-test|||||||0.487
70913689|NCT05826431|141318374|OTHER||Mean Difference (Final Values)|-0.06||||0.483|TWO_SIDED||||||Paired samples t-test|||||||0.483
70913690|NCT05826431|141318375|OTHER||Mean Difference (Final Values)|-2.82||||0.0483|TWO_SIDED||||||Paired samples t-test|||||||.0483
70913691|NCT05826431|141318376|OTHER||Mean Difference (Final Values)|-0.42||||0.123|TWO_SIDED||||||Paired samples t-test|||||||0.123
70913692|NCT04771273|141318377|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|3.47||||0.001|TWO_SIDED|95.0|1.66|7.25||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 2.4 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type and Baseline Fibrosis Score. Firth's penalized regression was used.||7.25|1.66|0.0010
70913693|NCT04771273|141318377|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|9.52|||<|0.0001|TWO_SIDED|95.0|4.35|20.85||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 4.8 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type and Baseline Fibrosis Score. Firth's penalized regression was used.||20.85|4.35|<0.0001
70913694|NCT04771273|141318377|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|7.07|||<|0.0001|TWO_SIDED|95.0|3.1|16.16||The p-value reported is considered nominal.|Regression, Logistic|||The logistic regression model included actual treatment, presence of diabetes of any type and Baseline Fibrosis Score. Firth's penalized regression was used.||16.16|3.10|<.0001
70913695|NCT04771273|141318377|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod linear model fit|Linear model fit assumption||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
70913696|NCT04771273|141318377|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod exponential-1 model fit|Model assumption: 25% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
70913697|NCT04771273|141318377|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."||||||0.0008|||||||MCP-Mod exponential -2 model fit|Model assumption: 5% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||0.0008
70913698|NCT04771273|141318377|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax1 model fit|Model assumption: 50% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
70913699|NCT04771273|141318377|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax2 model fit|Model assumption: 80% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
70913700|NCT04771273|141318377|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod quadratic model fit|Model assumption: Maximum effect is achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
70913701|NCT04771273|141318378|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|5.49|||<|0.0001|TWO_SIDED|95.0|2.46|12.28||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 2.4 mg vs. Placebo|The logistic regression model includes planned treatment, presence of diabetes of any type and Baseline Fibrosis Score. Firth's penalized regression was used.||12.28|2.46|<.0001
70913702|NCT04771273|141318378|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|10.14|||<|0.0001|TWO_SIDED|95.0|4.49|22.87||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 4.8 mg vs. Placebo|The logistic regression model includes planned treatment, presence of diabetes of any type and Baseline Fibrosis Score. Firth's penalized regression was used.||22.87|4.49|<.0001
70913703|NCT04771273|141318378|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|4.87||||0.0001|TWO_SIDED|95.0|2.18|10.91||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 6.0 mg vs. Placebo|The logistic regression model includes planned treatment, presence of diabetes of any type and Baseline Fibrosis Score. Firth's penalized regression was used.||10.91|2.18|0.0001
70913704|NCT04771273|141318378|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."||||||0.0001|||||||MCPMod linear model fit|linear model fit assumption||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||0.0001
70913705|NCT04771273|141318378|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."||||||0.0115|||||||MCPMod exponential-1 model fit|Model assumption: 25% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||0.0115
70913706|NCT04771273|141318378|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."||||||0.2204|||||||MCP-Mod exponential-2 model fit|Model assumption: 5% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||0.2204
70913707|NCT04771273|141318378|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax1 model fit|Model assumption: 50% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
70913708|NCT04771273|141318378|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax2|Model assumption: 80% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
70913709|NCT04771273|141318378|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod quadratic model fit|Model assumption: Maximum effect is achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
70913710|NCT04771273|141318379|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|5.07|||<|0.0001|TWO_SIDED|95.0|2.47|10.4||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 2.4 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type, baseline liver fat content and baseline fibrosis score. Firth's penalized regression was used.||10.40|2.47|<.0001
70913711|NCT04771273|141318379|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|9.46|||<|0.0001|TWO_SIDED|95.0|4.36|20.51||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 4.8 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type, baseline liver fat content and baseline fibrosis score. Firth's penalized regression was used.||20.51|4.36|<.0001
70913712|NCT04771273|141318379|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|16.09|||<|0.0001|TWO_SIDED|95.0|6.69|38.73||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 6.0 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type, baseline liver fat content and baseline fibrosis score. Firth's penalized regression was used.||38.73|6.69|<.0001
70970674|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2744|STANDARD_ERROR_OF_MEAN|0.1055||0.012|TWO_SIDED|80.0|0.13746|0.41127|||Mixed Models Analysis|||Week 3 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.41127|0.13746|0.0120
70913713|NCT04771273|141318379|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod linear model fit|Linear model fit assumption||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
70913714|NCT04771273|141318379|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod exponential-1 model fit|Model assumption: 25% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
70913715|NCT04771273|141318379|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod exponential-2 model fit|Model assumption: 5% of maximum effect achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
70913716|NCT04771273|141318379|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax1 model fit|Model assumption: 50% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
70913717|NCT04771273|141318379|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax2 model fit|Model assumption: 80% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
70913718|NCT04771273|141318379|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod quadratic model fit|Model assumption: Maximum effect is achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
70913719|NCT04771273|141318380|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|10.39|||<|0.0001|TWO_SIDED|95.0|4.6|23.45||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 2.4 mg vs. Placebo|The logistic regression model included planned treatment, presence of diabetes of any type, baseline liver fat content and baseline fibrosis score. Firth's penalized regression was used.||23.45|4.60|<.0001
70913720|NCT04771273|141318380|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|12.06|||<|0.0001|TWO_SIDED|95.0|5.3|27.45||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 4.8 mg vs. Placebo|The logistic regression model included planned treatment, presence of diabetes of any type, baseline liver fat content and baseline fibrosis score. Firth's penalized regression was used.||27.45|5.30|<.0001
70913721|NCT04771273|141318380|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|8.22|||<|0.0001|TWO_SIDED|95.0|3.66|18.5||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 6.0 mg vs. Placebo|The logistic regression model included planned treatment, presence of diabetes of any type, baseline liver fat content and baseline fibrosis score. Firth's penalized regression was used.||18.50|3.66|<.0001
70913722|NCT04771273|141318380|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod linear model fit|Linear model fit assumption.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
70913723|NCT04771273|141318380|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."||||||0.0031|||||||MCP-Mod exponential-1 model fit|Model assumption: 25% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||0.0031
70913724|NCT04771273|141318380|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."||||||0.0925|||||||MCP-Mod exponential-2 model fit|Model assumption: 5% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||0.0925
70913725|NCT04771273|141318380|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax1 model fit|Model assumption: 50% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
70913726|NCT04771273|141318380|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax2 model fit|Model assumption: 80% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
70913727|NCT04771273|141318380|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod quadratic model fit|Model assumption: Maximum effect is achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
70913728|NCT04771273|141318381|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-8.59|||<|0.0001|TWO_SIDED|95.0|-10.59|-6.6||The p-value reported is considered nominal.|MMRM||"Survodutide 2.4 mg - Placebo."|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-6.60|-10.59|<.0001
70970675|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1016|STANDARD_ERROR_OF_MEAN|0.1136||0.375|TWO_SIDED|80.0|-0.0457|0.24881|||Mixed Models Analysis|||Week 3 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.24881|-0.0457|0.3750
70970676|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4367|STANDARD_ERROR_OF_MEAN|3.9301||0.9119|TWO_SIDED|80.0|-4.665|5.5387|||Mixed Models Analysis|||Week 3 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.5387|-4.665|0.9119
70913729|NCT04771273|141318381|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-10.91|||<|0.0001|TWO_SIDED|95.0|-12.96|-8.86||The p-value reported is considered nominal.|MMRM||"Survodutide 4.8 mg - Placebo."|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-8.86|-12.96|<.0001
70913730|NCT04771273|141318381|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-11.07|||<|0.0001|TWO_SIDED|95.0|-13.23|-8.92||The p-value reported is considered nominal.|MMRM||"Survodutide 6.0 mg - Placebo."|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-8.92|-13.23|<.0001
70913731|NCT04771273|141318382|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-9.12|||<|0.0001|TWO_SIDED|95.0|-11.21|-7.03||The p-value reported is considered nominal.|MMRM||"Survodutide 2.4 mg - Placebo."|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-7.03|-11.21|<.0001
70913732|NCT04771273|141318382|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-10.79|||<|0.0001|TWO_SIDED|95.0|-12.85|-8.73||The p-value reported is considered nominal.|MMRM||"Survodutide 4.8 mg - Placebo."|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-8.73|-12.85|<.0001
70913733|NCT04771273|141318382|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-10.86|||<|0.0001|TWO_SIDED|95.0|-13.0|-8.73||The p-value reported is considered nominal.|MMRM||"Survodutide 6.0 mg - Placebo."|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-8.73|-13.00|<.0001
70913734|NCT04771273|141318383|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-43.64|||<|0.0001|TWO_SIDED|95.0|-53.49|-33.79||The p-value reported is considered nominal.|MMRM||"Survodutide 2.4 mg - Placebo"|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-33.79|-53.49|<.0001
70913735|NCT04771273|141318383|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-55.52|||<|0.0001|TWO_SIDED|95.0|-65.61|-45.42||The p-value reported is considered nominal.|MMRM||"Survodutide 4.8 mg - Placebo"|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-45.42|-65.61|<.0001
70913736|NCT04771273|141318383|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-57.02|||<|0.0001|TWO_SIDED|95.0|-67.66|-46.39||The p-value reported is considered nominal.|MMRM||"Survodutide 6.0 mg-Placebo"|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-46.39|-67.66|<.0001
70913737|NCT04771273|141318384|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-46.49|||<|0.0001|TWO_SIDED|95.0|-56.74|-36.25||The p-value reported is considered nominal.|MMRM||"Survodutide 2.4 mg - Placebo"|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-36.25|-56.74|<.0001
70913738|NCT04771273|141318384|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-55.11|||<|0.0001|TWO_SIDED|95.0|-65.25|-44.98||The p-value reported is considered nominal.|MMRM||"Survodutide 4.8 mg - Placebo"|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-44.98|-65.25|<.0001
70913739|NCT04771273|141318384|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-56.26|||<|0.0001|TWO_SIDED|95.0|-66.76|-45.77||The p-value reported is considered nominal.|MMRM||"Survodutide 6.0 mg-Placebo"|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-45.77|-66.76|<.0001
70913740|NCT04771273|141318385|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|1.61||||0.1894|TWO_SIDED|95.0|0.79|3.26||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 2.4 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type and baseline fibrosis score. Firth's penalized regression was used.||3.26|0.79|0.1894
70913741|NCT04771273|141318385|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|2.0||||0.0685|TWO_SIDED|95.0|0.95|4.2||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 4.8 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type and baseline fibrosis score. Firth's penalized regression was used.||4.20|0.95|0.0685
71092880|NCT01787838|141692248|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|||<|0.0001|TWO_SIDED|95.0|1.65|1.96|||Chi-squared|||Prospective data from 12 months were compared to data that had been collected for the previous 12 month period to determine statistical significance and trended outcomes for comparative periods. Patients were screened for eligibility during the first 12 months, and staff and patients received the interventions during the second 12 month period.||1.96|1.65|<.0001
71092881|NCT01431976|141692254|SUPERIORITY_OR_OTHER||percentage of participants|35.0|||||TWO_SIDED|95.0|15.39|59.22||||||||59.22|15.39|
70913742|NCT04771273|141318385|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|3.37||||0.0028|TWO_SIDED|95.0|1.52|7.45||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 6.0 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type and baseline fibrosis score. Firth's penalized regression was used.||7.45|1.52|0.0028
70913743|NCT04771273|141318386|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|2.02||||0.0663|TWO_SIDED|95.0|0.95|4.27||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 2.4 mg vs. Placebo|The logistic regression model included planned treatment, presence of diabetes of any type and baseline fibrosis score. Firth's penalized regression was used.||4.27|0.95|0.0663
70913744|NCT04771273|141318386|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|2.01||||0.0672|TWO_SIDED|95.0|0.95|4.23||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 4.8 mg vs. Placebo|The logistic regression model included planned treatment, presence of diabetes of any type and baseline fibrosis score. Firth's penalized regression was used.||4.23|0.95|0.0672
70913745|NCT04771273|141318386|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|2.11||||0.0512|TWO_SIDED|95.0|1.0|4.46||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 6.0 mg vs. Placebo|The logistic regression model included planned treatment, presence of diabetes of any type and baseline fibrosis score. Firth's penalized regression was used.||4.46|1.00|0.0512
70913746|NCT01543685|141318389|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|441.8|STANDARD_ERROR_OF_MEAN|129.6|<|0.001|TWO_SIDED|95.0|187.1|696.5|||ANCOVA|||||696.5|187.1|<0.001
70913747|NCT01543685|141318389|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|260.2|STANDARD_ERROR_OF_MEAN|130.3||0.046|TWO_SIDED|95.0|4.1|516.3|||ANCOVA|||||516.3|4.1|0.046
70913748|NCT01543685|141318389|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|312.7|STANDARD_ERROR_OF_MEAN|130.4||0.017|TWO_SIDED|95.0|56.6|568.9|||ANCOVA|||||568.9|56.6|0.017
70913749|NCT01543685|141318389|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|211.6|STANDARD_ERROR_OF_MEAN|129.6||0.103|TWO_SIDED|95.0|-43.1|466.2|||ANCOVA|||||466.2|-43.1|0.103
70913750|NCT01543685|141318390|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||t-test, 2 sided|||||||0.013
70913751|NCT01543685|141318390|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||t-test, 2 sided|||||||0.014
70913752|NCT01543685|141318390|SUPERIORITY_OR_OTHER|||||||0.211||95.0|||||t-test, 2 sided|||||||0.211
70913753|NCT01543685|141318390|SUPERIORITY_OR_OTHER|||||||0.098||95.0|||||t-test, 2 sided|||||||0.098
70913754|NCT01543685|141318391|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||||||0.001
70913755|NCT01543685|141318391|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
70913756|NCT01543685|141318391|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||t-test, 2 sided|||||||0.017
70913757|NCT01543685|141318391|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||t-test, 2 sided|||||||0.028
70913758|NCT01543685|141318392|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
70913759|NCT01543685|141318392|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
70913760|NCT01543685|141318392|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
70913761|NCT01543685|141318392|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||t-test, 2 sided|||||||0.015
70913762|NCT01543685|141318393|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
70913763|NCT01543685|141318393|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||t-test, 2 sided|||||||0.022
70913764|NCT01543685|141318393|SUPERIORITY_OR_OTHER|||||||0.146||95.0|||||t-test, 2 sided|||||||0.146
70913765|NCT01543685|141318393|SUPERIORITY_OR_OTHER|||||||0.071||95.0|||||t-test, 2 sided|||||||0.071
70913766|NCT01543685|141318394|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
70913767|NCT01543685|141318394|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||t-test, 2 sided|||||||0.008
70913768|NCT01543685|141318394|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||||||0.010
70913769|NCT01543685|141318394|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||t-test, 2 sided|||||||0.016
70913770|NCT01543685|141318395|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
70913771|NCT01543685|141318395|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||t-test, 2 sided|||||||0.008
70913772|NCT01543685|141318395|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||||||0.005
70913773|NCT01543685|141318395|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||t-test, 2 sided|||||||0.017
70913774|NCT01543685|141318396|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71092882|NCT00055237|141692262|SUPERIORITY_OR_OTHER||proportion estimate,binomial exact 95%CI|31.0|STANDARD_DEVIATION|11.6|||TWO_SIDED|95.0|11.0|58.7|||sample estimate with 95% CI||As stated in the Outcome statistical Analysis 1. Section, the confidence interval was calculated using binomial exact statistics. The standard deviation is based on that calculation.|||58.7|11|
71092883|NCT02127671|141692277|SUPERIORITY||Mean Difference (Net)|-12.7|||||TWO_SIDED|95.0|-22.9|-2.5||||||||-2.5|-22.9|
70913775|NCT01543685|141318396|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||||||0.020
70913776|NCT01543685|141318396|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||t-test, 2 sided|||||||0.012
70913777|NCT01543685|141318396|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||t-test, 2 sided|||||||0.029
70913778|NCT01304147|141318429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.6|||<|0.001|TWO_SIDED|95.0|3.9|11.3|||Paired t-test, 2 sided|||within-subject crossover design||11.3|3.9|<0.001
70913779|NCT00708097|141318431|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.98||||0.5757|TWO_SIDED|95.0|-5.0|8.97||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||8.97|-5.00|0.5757
70913780|NCT00708097|141318432|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.17||||0.5387|TWO_SIDED|95.0|-4.79|9.14||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||9.14|-4.79|0.5387
70913781|NCT00708097|141318432|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.79||||0.4306|TWO_SIDED|95.0|-4.18|9.77||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||9.77|-4.18|0.4306
70913782|NCT00708097|141318432|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-25.07|||<|0.0001|TWO_SIDED|95.0|-32.09|-18.06||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||-18.06|-32.09|<0.0001
70913783|NCT00708097|141318432|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.19||||0.9567|TWO_SIDED|95.0|-6.71|7.09||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||7.09|-6.71|0.9567
70913784|NCT00708097|141318432|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.81||||0.8188|TWO_SIDED|95.0|-6.14|7.76||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||7.76|-6.14|0.8188
70913785|NCT00708097|141318432|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.06|||<|0.0001|TWO_SIDED|95.0|-34.03|-20.08||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||-20.08|-34.03|<0.0001
70913786|NCT00708097|141318432|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.62||||0.8599|TWO_SIDED|95.0|-6.28|7.51||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||7.51|-6.28|0.8599
70913787|NCT00708097|141318432|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.25|||<|0.0001|TWO_SIDED|95.0|-34.2|-20.3||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||-20.30|-34.20|<0.0001
70913788|NCT00708097|141318432|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.87|||<|0.0001|TWO_SIDED|95.0|-34.84|-20.89||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||-20.89|-34.84|<0.0001
70913789|NCT00708097|141318433|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.45||||0.5451|TWO_SIDED|95.0|-6.15|3.26||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||3.26|-6.15|0.5451
70913790|NCT00708097|141318433|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.5||||0.1433|TWO_SIDED|95.0|-1.2|8.19||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||8.19|-1.20|0.1433
70913791|NCT00708097|141318433|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.47||||0.002|TWO_SIDED|95.0|2.78|12.16||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||12.16|2.78|0.0020
70913792|NCT00708097|141318433|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|23.52|||<|0.0001|TWO_SIDED|95.0|18.79|28.25||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||28.25|18.79|<0.0001
70913793|NCT00708097|141318433|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.94||||0.0373|TWO_SIDED|95.0|0.29|9.59||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||9.59|0.29|0.0373
70913794|NCT00708097|141318433|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.92||||0.0002|TWO_SIDED|95.0|4.24|13.59||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||13.59|4.24|0.0002
70913795|NCT00708097|141318433|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|24.97|||<|0.0001|TWO_SIDED|95.0|20.27|29.66||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||29.66|20.27|<0.0001
70913796|NCT00708097|141318433|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.98||||0.0925|TWO_SIDED|95.0|-0.66|8.61||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||8.61|-0.66|0.0925
70913797|NCT00708097|141318433|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|20.03|||<|0.0001|TWO_SIDED|95.0|15.35|24.7||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||24.70|15.35|<0.0001
70913798|NCT00708097|141318433|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|16.05|||<|0.0001|TWO_SIDED|95.0|11.36|20.74||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||20.74|11.36|<0.0001
70913799|NCT00708097|141318434|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.01||||0.9697|TWO_SIDED|95.0|-106.34|102.32||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||102.32|-106.34|0.9697
70913800|NCT00708097|141318434|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|106.9||||0.044|TWO_SIDED|95.0|2.92|210.87||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||210.87|2.92|0.0440
70913801|NCT00708097|141318434|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|160.92||||0.0026|TWO_SIDED|95.0|56.96|264.88||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||264.88|56.96|0.0026
70913802|NCT00708097|141318434|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|222.47|||<|0.0001|TWO_SIDED|95.0|117.58|327.36||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||327.36|117.58|<0.0001
70913803|NCT00708097|141318434|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|108.91||||0.0382|TWO_SIDED|95.0|5.98|211.83||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||211.83|5.98|0.0382
70913804|NCT00708097|141318434|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|162.93||||0.0021|TWO_SIDED|95.0|59.68|266.18||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||266.18|59.68|0.0021
70913805|NCT00708097|141318434|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|224.48|||<|0.0001|TWO_SIDED|95.0|120.51|328.46||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||328.46|120.51|<0.0001
70913806|NCT00708097|141318434|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|54.03||||0.3003|TWO_SIDED|95.0|-48.56|156.61||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||156.61|-48.56|0.3003
70913807|NCT00708097|141318434|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|61.55||||0.2432|TWO_SIDED|95.0|-42.14|165.24||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||165.24|-42.14|0.2432
70913808|NCT00708097|141318434|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|115.58||||0.0289|TWO_SIDED|95.0|12.02|219.13||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||219.13|12.02|0.0289
70913809|NCT00708097|141318435|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-13.9||||0.9293|TWO_SIDED|95.0|-322.47|294.66||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||294.66|-322.47|0.9293
70913810|NCT00708097|141318435|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|575.71||||0.0003|TWO_SIDED|95.0|268.24|883.17||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||883.17|268.24|0.0003
70913811|NCT00708097|141318435|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|637.67|||<|0.0001|TWO_SIDED|95.0|330.3|945.03||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||945.03|330.30|<0.0001
70913812|NCT00708097|141318435|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1813.29|||<|0.0001|TWO_SIDED|95.0|1503.03|2123.54||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||2123.54|1503.03|<0.0001
70913813|NCT00708097|141318435|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|589.61||||0.0002|TWO_SIDED|95.0|285.31|893.92|||ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||893.92|285.31|0.0002
70913814|NCT00708097|141318435|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|651.57|||<|0.0001|TWO_SIDED|95.0|346.44|956.7||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||956.70|346.44|<0.0001
71092884|NCT02127671|141692279|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.7|0.9||||||||0.9|-0.7|
70913815|NCT00708097|141318435|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1827.19|||<|0.0001|TWO_SIDED|95.0|1519.78|2134.6||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||2134.60|1519.78|<0.0001
70913816|NCT00708097|141318435|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|61.96||||0.6874|TWO_SIDED|95.0|-241.25|365.17||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||365.17|-241.25|0.6874
70913817|NCT00708097|141318435|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1237.58|||<|0.0001|TWO_SIDED|95.0|931.46|1543.7|||ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||1543.70|931.46|<0.0001
70913818|NCT00708097|141318435|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1175.62|||<|0.0001|TWO_SIDED|95.0|869.15|1482.1||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||1482.10|869.15|<0.0001
70913819|NCT01278862|141318445|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2423|||||||Fisher Exact|||null hypothesis no difference in color match||||0.2423
70913820|NCT01278862|141318445|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||null hypothesis no difference in margin discoloration||||>0.999
70913821|NCT01278862|141318445|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||null hypothesis no difference in crown fracture||||>0.999
70913822|NCT01278862|141318445|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999|||||||Fisher Exact|||Null hypothesis no difference in Proximal Contact - Mesial||||>0.999
70913823|NCT01278862|141318445|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999|||||||Fisher Exact|||Null hypothesis no difference in proximal contact - distal||||>0.999
70913824|NCT01278862|141318446|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||null hypothesis no difference in gingival index||||>0.999
70913825|NCT01278862|141318446|SUPERIORITY|||||||0.524|||||||Fisher Exact|||null hypothesis no difference in plaque index||||0.5240
70913826|NCT04520165|141318447|EQUIVALENCE|if p\<0.05 than the null hypothesis was considered as wrong and groups differed for the analysed parameter.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||The baseline parameters in each group were compared with Mann-Whitney U test was performed.||||<0.05
70913827|NCT04520165|141318449|EQUIVALENCE|if p\<0.05 than the null hypothesis was considered as wrong and groups differed for the analysed parameter.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||The baseline parameters in each group were compared with Mann-Whitney U test was performed.||||<0.05
70913828|NCT04520165|141318450|EQUIVALENCE|if p\<0.05 than the null hypothesis was considered as wrong and groups differed for the analysed parameter.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||The baseline parameters in each group were compared with Mann-Whitney U test was performed.||||<0.05
70913829|NCT00798265|141318503|OTHER|||||||0.002||||||The reported p-value is representative of the changes in HPV-16 at 7 months in Cohort 1.|Spearman correlation (non-parametric)|||||||0.0020
70913830|NCT00798265|141318503|OTHER||||||<|0.0001||||||The reported p-value is representative of the changes in HPV-18 at 7 months in Cohort 1.|Spearman correlation (non-parametric)|||||||<.0001
70913831|NCT00798265|141318503|OTHER|||||||0.0002||||||The reported p-value is representative of the changes in HPV-16 at 7 months in Cohort 2.|Spearman correlation (non-parametric)|||||||0.0002
70913832|NCT00798265|141318503|OTHER||||||<|0.0001||||||The reported p-value is representative of the changes in HPV-18 at 7 months in Cohort 2.|Spearman correlation (non-parametric)|||||||<.0001
70913833|NCT02162446|141318512|OTHER|||||||0.016|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in total tissues between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.016
70913834|NCT02162446|141318512|OTHER|||||||0.004|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in total tissues between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.004
70913835|NCT02162446|141318512|OTHER|||||||0.012|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.012
70913836|NCT02162446|141318512|OTHER|||||||0.004|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.004
70913837|NCT02162446|141318512|OTHER|||||||0.5|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.500
70913838|NCT02162446|141318512|OTHER|||||||1|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||1.000
70913839|NCT02162446|141318514|OTHER|||||||0.25|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.250
70913840|NCT02162446|141318514|OTHER|||||||0.004|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.004
70913841|NCT02162446|141318514|OTHER|||||||0.688|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.688
70913842|NCT02162446|141318514|OTHER|||||||0.578|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.578
70913843|NCT02162446|141318515|OTHER|||||||0.027|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in liver between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.027
70913844|NCT02162446|141318515|OTHER|||||||0.219|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in lymph node between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.219
70913845|NCT02162446|141318516|OTHER|||||||0.064|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.064
71153808|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.0003||||1||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135||||1.00
70913846|NCT02162446|141318516|OTHER|||||||0.339|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.339
70913847|NCT02162446|141318516|OTHER|||||||0.001|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.001
70913848|NCT02162446|141318516|OTHER|||||||0|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.000
70913849|NCT02162446|141318516|OTHER|||||||0.297|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.297
70913850|NCT02162446|141318516|OTHER|||||||1|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||1.000
70913851|NCT02162446|141318517|OTHER|||||||0.47|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in muscle between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.470
70913852|NCT02162446|141318517|OTHER|||||||0.233|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in liver between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.233
70913853|NCT02162446|141318517|OTHER|||||||0.375|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in lymph node between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.375
70913854|NCT02162446|141318518|OTHER|||||||0.004|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.004
70913855|NCT02162446|141318518|OTHER|||||||0.004|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.004
70913856|NCT02162446|141318518|OTHER|||||||0.426|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.426
70913857|NCT02162446|141318518|OTHER|||||||0.098|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.098
70913858|NCT02162446|141318518|OTHER|||||||0.813|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.813
70913859|NCT02162446|141318518|OTHER|||||||0.813|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.813
70913860|NCT02162446|141318518|OTHER|||||||0.297|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.297
70913861|NCT02162446|141318518|OTHER|||||||0.469|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.469
70913862|NCT02162446|141318519|OTHER|||||||0.91|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as liver between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.910
70913863|NCT02162446|141318519|OTHER|||||||0.039|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as muscle between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.039
70913864|NCT02162446|141318519|OTHER|||||||0.375|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as lymph node between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.375
70913865|NCT02162446|141318519|OTHER|||||||0.219|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as muscle between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.219
70913866|NCT00739102|141318524|SUPERIORITY_OR_OTHER||Proportion - 12-month patency rate|0.665|STANDARD_ERROR_OF_MEAN|0.032||0.437|TWO_SIDED|95.0|0.6|0.725||The observed rate of primary patency at 12 month was 66.5% (143/215) with a lower 95% confidence interval of 60.0%.|Agresti-Coull method||The 95% confidence intervals and the standard error were calculated using the Agresti-Coull method|The null hypothesis to be tested was Ho: P = 0.66 against Ha: P \> 0.66, where 0.66 was the Objective Performance Criteria (OPC). A sample size of 212 subjects was required to achieve 90% power to reject the 66% 12-months patency rate at a one-sided 2.5% significance level when the unknown true patency is at 76%.||0.725|0.6|0.437
70913867|NCT00739102|141318526|SUPERIORITY_OR_OTHER||Death Rate (%)|2.1|||||TWO_SIDED|95.0|0.7|4.9||||||||4.9|0.7|
70913868|NCT00739102|141318527|SUPERIORITY_OR_OTHER||Index Limb Amputation Rate (%)|0.0|||||TWO_SIDED|95.0|0.0|1.5||||||||1.5|0.0|
70913869|NCT00739102|141318528|SUPERIORITY_OR_OTHER||Clinically Driven TVR Rate (%)|0.0|||||TWO_SIDED|95.0|0.0|1.5||||||||1.5|0.0|
70913870|NCT00739102|141318529|SUPERIORITY_OR_OTHER||Clinically Driven TVR Rate (%)|13.6|||||TWO_SIDED|95.0|9.5|18.6||||||||18.6|9.5|
70913871|NCT00739102|141318530|SUPERIORITY_OR_OTHER||Stent Fracture Rate (%)|1.5|||||TWO_SIDED|95.0|0.3|4.4||||||||4.4|0.3|
70913872|NCT00739102|141318531|SUPERIORITY_OR_OTHER||Index Limb Ischemia Rate (%)|5.6||||||95.0||||||||||||
70913873|NCT00739102|141318532|SUPERIORITY_OR_OTHER||Primary safety endpoint rate (%)|100.0|||<|0.001|TWO_SIDED|95.0|98.2|100.0|||Agresti-Coull method|||The null hypothesis to be tested was Ho: P = 0.88 against Ha: P \> 0.88, where 0.88 was the Objective Performance Criteria (OPC).||100|98.2|<0.001
70913874|NCT00739102|141318533|SUPERIORITY_OR_OTHER||Index Limb Ischemia Rate (%)|8.4||||||95.0||||||||||||
70913875|NCT00739102|141318536|SUPERIORITY_OR_OTHER||Major adverse event rate (%)|14.4|||||TWO_SIDED|95.0|10.2|19.5||||||||19.5|10.2|
70913876|NCT01090024|141318543|SUPERIORITY|One-sided p-value testing superiority of BI 671800 vs placebo with 2.5% alpha.|Adjusted means difference|0.083|STANDARD_ERROR_OF_MEAN|0.624||0.4473|TWO_SIDED|95.0|-1.147|1.313|||Mixed effect model||Adjusted means difference of BI 671800 200 mg BID (D) vs Placebo (A).|Restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM) with terms for baseline, treatment and period as fixed effects and patient as a random effect was used. A compound symmetry covariance structure was used.||1.313|-1.147|0.4473
70913877|NCT01090024|141318543|SUPERIORITY|One-sided p-value testing superiority of BI 671800 vs placebo with 2.5% alpha.|Adjusted means difference|0.67|STANDARD_ERROR_OF_MEAN|0.625||0.1426|TWO_SIDED|95.0|-0.563|1.903|||Mixed effect model||Adjusted means difference of BI 671800 400 mg PM QD (C) vs Placebo (A).|Restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM) with terms for baseline, treatment and period as fixed effects and patient as a random effect was used. A compound symmetry covariance structure was used.||1.903|-0.563|0.1426
70913878|NCT01090024|141318543|SUPERIORITY|One-sided p-value testing superiority of BI 671800 vs placebo with 2.5% alpha.|Adjusted means difference|0.281|STANDARD_ERROR_OF_MEAN|0.611||0.3231|TWO_SIDED|95.0|-0.924|1.486|||Mixed effect model||Adjusted means difference of BI 671800 400 mg AM QD (B) vs Placebo (A).|Restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM) with terms for baseline, treatment and period as fixed effects and patient as a random effect was used. A compound symmetry covariance structure was used.||1.486|-0.924|0.3231
70913879|NCT01090024|141318544|SUPERIORITY|One-sided p-value testing superiority of BI 671800 vs placebo with 2.5% alpha.|Adjusted means difference|-0.056|STANDARD_ERROR_OF_MEAN|0.063||0.1879|TWO_SIDED|95.0|-0.18|0.068|||Mixed effect model||Adjusted means difference of BI 671800 200 mg BID (D) vs Placebo (A).|Restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM) with terms for baseline, treatment and period as fixed effects and patient as a random effect was used. A autoregressive covariance structure was used.||0.068|-0.180|0.1879
70913880|NCT01090024|141318544|SUPERIORITY|One-sided p-value testing superiority of BI 671800 vs placebo with 2.5% alpha.|Adjusted means difference|-0.026|STANDARD_ERROR_OF_MEAN|0.063||0.3384|TWO_SIDED|95.0|-0.151|0.098|||Mixed effect model||Adjusted means difference of BI 671800 400 mg PM QD (C) vs Placebo (A).|Restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM) with terms for baseline, treatment and period as fixed effects and patient as a random effect was used. A autoregressive covariance structure was used.||0.098|-0.151|0.3384
70913881|NCT01090024|141318544|SUPERIORITY|One-sided p-value testing superiority of BI 671800 vs placebo with 2.5% alpha.|Adjusted means difference|-0.093|STANDARD_ERROR_OF_MEAN|0.062||0.067|TWO_SIDED|95.0|-0.214|0.029|||Mixed effect model||Adjusted means difference of BI 671800 400 mg AM QD (B) vs Placebo (A).|Restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM) with terms for baseline, treatment and period as fixed effects and patient as a random effect was used. A autoregressive covariance structure was used.||0.029|-0.214|0.0670
70913882|NCT00920686|141318565|SUPERIORITY_OR_OTHER|||||||0.6407|||||||Log Rank|||||||0.6407
70913883|NCT01444287|141318583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.636|STANDARD_ERROR_OF_MEAN|0.2093||0.0035||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: No Lenses (control) - narafilcon B (test) = 0. Ha: No Lenses (control) - narafilcon B (test) ≠ 0.||||0.0035
70913884|NCT01444287|141318583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.743|STANDARD_ERROR_OF_MEAN|0.2093||0||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control - Test.|Ho: Polymacon (+ control) - Narafilcon B (test) = 0. Ha: Polymacon (+ control) - Narafilcon B (test) ≠ 0.||||0.0000
70913885|NCT01444287|141318583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0275|STANDARD_ERROR_OF_MEAN|0.2093||0.8957||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: lotrafilcon A (control) - narafilcon B (test) = 0. Ha: lotrafilcon A (control) - narafilcon B (test) ≠ 0.||||0.8957
70913886|NCT01444287|141318584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0057|STANDARD_ERROR_OF_MEAN|0.0031||0.0692||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: No Lenses (control) - narafilcon B (test) = 0. Ha: No Lenses (control) - narafilcon B (test) ≠ 0.||||0.0692
70970677|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.3429|STANDARD_ERROR_OF_MEAN|4.1977||0.1367|TWO_SIDED|80.0|-11.79|-0.896|||Mixed Models Analysis|||Week 3 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.8960|-11.79|0.1367
71153809|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.004||||1||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y||||1.00
71153810|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.3||||0.37||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.37
71153811|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.52||||0.09||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A||||0.09
71153812|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.21||||0.4||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A||||0.40
71153813|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.28||||0.2||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C||||0.20
71153814|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.41||||0.03||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C||||0.03
71153815|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.48||||0.07||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.07
71153816|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.22||||0.3||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.30
71153817|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.26||||0.74||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.74
71153818|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.378||||0.25||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.25
71153819|NCT00488683|141800057|SUPERIORITY_OR_OTHER||R-square|0.69||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A||||
71153820|NCT00488683|141800057|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A||||
71153821|NCT00488683|141800057|SUPERIORITY_OR_OTHER||R-square|0.42||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C||||
71153822|NCT00488683|141800057|SUPERIORITY_OR_OTHER||R-square|0.1||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C||||
71092885|NCT02127671|141692283|SUPERIORITY||Mean Difference (Net)|-7.6|||||TWO_SIDED|95.0|-17.6|2.4||||||||2.4|-17.6|
71092886|NCT02127671|141692284|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.3|0.2||||||||0.2|-0.3|
71153823|NCT00488683|141800057|SUPERIORITY_OR_OTHER||R-square|0.0004||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135||||
71153824|NCT00488683|141800057|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135||||
71153825|NCT00488683|141800057|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y||||
71153826|NCT00488683|141800057|SUPERIORITY_OR_OTHER||R-square|0.9||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y||||
71153827|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.04||||0.86||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.86
71153828|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.08||||0.7||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.7
70913887|NCT01444287|141318584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0011|STANDARD_ERROR_OF_MEAN|0.0032||0.7301||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: Polymacon (+ control) - Narafilcon B (test) = 0. Ha: Polymacon (+ control) - Narafilcon B (test) ≠ 0.||||0.7301
70913888|NCT01444287|141318584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0008|STANDARD_ERROR_OF_MEAN|0.0032||0.8055||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: lotrafilcon A (control) - narafilcon B (test) = 0. Ha: lotrafilcon A (control) - narafilcon B (test) ≠ 0.||||0.8055
70913889|NCT01444287|141318585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0122|STANDARD_ERROR_OF_MEAN|0.1111||0.9127||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: No Lenses (control) - narafilcon B (test) = 0. Ha: No Lenses (control) - narafilcon B (test) ≠ 0.||||0.9127
70913890|NCT01444287|141318585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6864|STANDARD_ERROR_OF_MEAN|0.1098||0||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: Polymacon (+ control) - Narafilcon B (test) = 0. Ha: Polymacon (+ control) - Narafilcon B (test) ≠ 0.||||0.0000
70913891|NCT01444287|141318585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1705|STANDARD_ERROR_OF_MEAN|0.1098||0.1256||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: lotrafilcon A (control) - narafilcon B (test) = 0. Ha: lotrafilcon A (control) - narafilcon B (test) ≠ 0.||||0.1256
70913892|NCT01444287|141318586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0688|STANDARD_ERROR_OF_MEAN|5.044||0.9892||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: No Lenses (control) - narafilcon B (test) = 0. Ha: No Lenses (control) - narafilcon B (test) ≠ 0.||||0.9892
70913893|NCT01444287|141318586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.75|STANDARD_ERROR_OF_MEAN|4.984||0.0007||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: Polymacon (+ control) - Narafilcon B (test) = 0. Ha: Polymacon (+ control) - Narafilcon B (test) ≠ 0.||||0.0007
70913894|NCT01444287|141318586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.37|STANDARD_ERROR_OF_MEAN|4.984||0.003||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: lotrafilcon A (control) - narafilcon B (test) = 0. Ha: lotrafilcon A (control) - narafilcon B (test) ≠ 0.||||0.0030
70913895|NCT01651949|141318706|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.11|||<|0.001|TWO_SIDED|95.0|1.02|1.21|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used.||Anti-HPV Type 6||1.21|1.02|<0.001
70913896|NCT01651949|141318706|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|1.0|1.19|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 11||1.19|1.00|<0.001
70913897|NCT01651949|141318706|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.2|||<|0.001|TWO_SIDED|95.0|1.1|1.3|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 16||1.30|1.10|<0.001
70913898|NCT01651949|141318706|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.19|||<|0.001|TWO_SIDED|95.0|1.08|1.31|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 18||1.31|1.08|<0.001
70913899|NCT01651949|141318706|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.24|||<|0.001|TWO_SIDED|95.0|1.13|1.37|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 31||1.37|1.13|<0.001
70913900|NCT01651949|141318706|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.19|||<|0.001|TWO_SIDED|95.0|1.1|1.3|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 33||1.30|1.10|<0.001
70913901|NCT01651949|141318706|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.27|||<|0.001|TWO_SIDED|95.0|1.14|1.41|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 45||1.41|1.14|<0.001
70913902|NCT01651949|141318706|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.15|||<|0.001|TWO_SIDED|95.0|1.05|1.26|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 52||1.26|1.05|<0.001
70913903|NCT01651949|141318706|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.25|||<|0.001|TWO_SIDED|95.0|1.14|1.36|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 58||1.36|1.14|<0.001
70913904|NCT01651949|141318707|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-11.5|||<|0.001|TWO_SIDED|95.0|-15.0|-8.0|||Miettinen & Nurminen||The incidence of AEs of injection-site erythema reported on the Vaccination Report Card was compared between heterosexual / MSM male participants and female participants|Injection-site Erythema||-8.0|-15.0|<0.001
70913905|NCT01651949|141318707|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-19.1|||<|0.001|TWO_SIDED|95.0|-22.5|-15.7|||Miettinen & Nurminen||The incidence of AEs of injection-site erythema reported on the Vaccination Report Card was compared between heterosexual / MSM male participants and female participants|Injection-site Pain||-15.7|-22.5|<0.001
70913906|NCT01651949|141318707|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-17.3|||<|0.001|TWO_SIDED|95.0|-20.8|-13.7|||Miettinen & Nurminen||The incidence of AEs of injection-site erythema reported on the Vaccination Report Card was compared between heterosexual / MSM male participants and female participants|Injection-site Swelling||-13.7|-20.8|<0.001
70913907|NCT01651949|141318708|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.5||||0.091|TWO_SIDED|95.0|-3.4|0.2|||Miettinen & Nurminen||The incidence of maximum body temperature \>=37.8° C reported on the Vaccination Report Card was compared between heterosexual / MSM male participants and female participants|Elevated Body Temperature||0.2|-3.4|0.091
70913908|NCT01651949|141318709|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.1|||<|0.001|TWO_SIDED|95.0|-0.7|0.9|||Miettinen & Nurminen|||Anti-HPV Type 6||0.9|-0.7|<0.001
70913909|NCT01651949|141318709|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.1|||<|0.001|TWO_SIDED|95.0|-0.3|0.8|||Miettinen & Nurminen|||Anti-HPV Type 11||0.8|-0.3|<0.001
70913910|NCT01651949|141318709|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.1|||<|0.001|TWO_SIDED|95.0|-0.3|0.7|||Miettinen & Nurminen|||Anti-HPV Type 16||0.7|-0.3|<0.001
70913911|NCT01651949|141318709|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.1|||<|0.001|TWO_SIDED|95.0|-0.4|0.8|||Miettinen & Nurminen|||Anti-HPV Type 18||0.8|-0.4|<0.001
70913912|NCT01651949|141318709|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.0|||<|0.001|TWO_SIDED|95.0|-0.4|0.5|||Miettinen & Nurminen|||Anti-HPV Type 31||0.5|-0.4|<0.001
70913913|NCT01651949|141318709|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.1|||<|0.001|TWO_SIDED|95.0|-0.3|0.7|||Miettinen & Nurminen|||Anti-HPV Type 33||0.7|-0.3|<0.001
70913914|NCT01651949|141318709|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.2|||<|0.001|TWO_SIDED|95.0|-0.4|1.0|||Miettinen & Nurminen|||Anti-HPV Type 45||1.0|-0.4|<0.001
70913915|NCT01651949|141318709|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.2|||<|0.001|TWO_SIDED|95.0|-0.2|0.9|||Miettinen & Nurminen|||Anti-HPV Type 52||0.9|-0.2|<0.001
70913916|NCT01651949|141318709|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.2|||<|0.001|TWO_SIDED|95.0|-0.2|0.9|||Miettinen & Nurminen|||Anti-HPV Type 58||0.9|-0.2|<0.001
70913917|NCT01806714|141318712|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.3|||<|0.04|TWO_SIDED|95.0|1.0|1.6|||clustered stratified Proportional Hazard||We determined hazard ratios using a clustered stratified Cox model with the Efron method to handle tied events and the Huber/White variance estimator that clustered on primary care provider and stratified on practice.|||1.6|1.0|<0.04
70913918|NCT02469064|141318715|OTHER||Hazard Ratio (HR)|0.82||||0.84|TWO_SIDED|95.0|0.55|1.2|||Mann Whitneey||Univariate analysis of the probability of extubation was performed using Kaplan-Meir survival analysis and the logrank test.The multivariate analysis was performed by cox regression, a simple model was performed and a final model.|||1.20|0.55|0.84
70913919|NCT02469064|141318716|OTHER||Slope|0.46||||0.48|TWO_SIDED|95.0|-3.75|4.78|||t-test, 2 sided||The slope shows the difference between the means of the change in the MIP of the group that received the experimental treatment and the group that received the conventional treatment|||4.78|-3.75|0.48
70913920|NCT00678795|141318717|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.11||||0.569|TWO_SIDED|95.0|-0.47|0.26|||ANCOVA|||The primary endpoint, the change in the number of incontinence episodes per day, was compared between treatment groups using analysis of covariance (ANCOVA). The model included treatment and centre as factors and baseline number of incontinence episodes per day as a covariate.||0.26|-0.47|0.569
70913921|NCT00678795|141318718|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.76||||0.071|TWO_SIDED|95.0|-1.58|0.07|||ANCOVA|||The change in the number of urgency episodes per day was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline number of urgency episodes per day as a covariate.||0.07|-1.58|0.071
70913922|NCT00678795|141318719|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.28||||0.01|TWO_SIDED|95.0|-0.5|-0.07|||ANCOVA|||The change in the number of nocturia episodes per day was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline number of nocturia episodes per day as a covariate.||-0.07|-0.50|0.010
70913923|NCT00678795|141318720|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.08||||0.74|TWO_SIDED|95.0|-0.57|0.41|||ANCOVA|||The change in the number of incontinence pads used per day was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline number of number of incontinence pads used per day as a covariate.||0.41|-0.57|0.74
70913924|NCT00678795|141318721|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|3.9||||0.166|TWO_SIDED|95.0|-1.65|9.46|||ANCOVA|||The change from baseline in the I-QOL score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline I-QOL score as a covariate.||9.46|-1.65|0.166
70970678|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.0062|STANDARD_ERROR_OF_MEAN|3.1094||0.0595|TWO_SIDED|80.0|-10.05|-1.964|||Mixed Models Analysis|||Week 3 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.964|-10.05|0.0595
70913925|NCT00678795|141318722|SUPERIORITY_OR_OTHER_LEGACY||Slope|-1.16||||0.001|TWO_SIDED|95.0|-1.82|-0.51|||ANCOVA|||The change from baseline in the overall bladder condition Numerical Rating Scale score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline overall bladder condition Numerical Rating Scale score as a covariate.||-0.51|-1.82|0.001
70913926|NCT00678795|141318723|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|25.4||||0.002|TWO_SIDED|95.0|10.37|40.42|||Fisher Exact|||For Patient Global Impression of Change, the proportions of subjects who considered their condition 'Very Much Improved', 'Much Improved' or 'Minimally Improved' were compared between treatment groups using Fisher's Exact Test.||40.42|10.37|0.002
70913927|NCT00678795|141318724|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.85||||0.007|TWO_SIDED|95.0|-1.47|-0.23|||ANCOVA|||The change in the number of voids per day was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline number of voids per day as a covariate.||-0.23|-1.47|0.007
70913928|NCT00404079|141318734|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.5|STANDARD_DEVIATION|4.0||0.05|||||||Mixed Models Analysis|||Null hypothesis was glucosamine sulfate is not superior to placebo to reduce pain and disability associated with chronic low back pain. Power calculation was based on a 3 point difference between the groups with the primary outcome. Data was analysed with linear mixed models||||0.05
70913929|NCT00404079|141318734|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Mixed Models Analysis|||||||0.05
70913930|NCT01120275|141318737|SUPERIORITY_OR_OTHER||6-month PFS|0.09|||||TWO_SIDED|95.0|0.02|0.22||||||6-month progression free survival (PFS) was estimated using the method of Kaplan-Meier and confidence intervals were calculated using the log-log transformation.||0.22|0.02|
70913931|NCT01120275|141318738|SUPERIORITY_OR_OTHER||1-year OS|0.5|||||TWO_SIDED|95.0|0.32|0.66||||||1-year overall survival (OS) was estimated using the method of Kaplan-Meier and confidence intervals were calculated using the log-log transformation.||0.66|0.32|
70913932|NCT02595398|141318741|SUPERIORITY||Difference in percentages|31.25|||<|0.001|TWO_SIDED|95.0|15.5|45.9||The a priori threshold for statistical significance was 0.050. Prior to evaluating the results of the CMH test, a Breslow-Day test with Tarone's adjustment was conducted to confirm the homogeneity of the odds ratios between country strata.|Cochran-Mantel-Haenszel|The CMH test was stratified by the country, i.e., US+Israel and India.|Estimated value was calculated as the percentage of subjects in the Active arm meeting the primary endpoint minus the percentage of subjects in the Control arm meeting the primary endpoint.|A total sample size of 150 subjects in a 3:2 randomization had 90% power to detect a difference between treatments in the proportion of subjects showing improvement is 0.60 for treated and 0.34 for sham. The primary analysis was a test of superiority of the CLS-TA arm over the sham arm, and was based on a Cochran-Mantel-Haenszel chi-square test stratified by country.||45.9|15.5|<0.001
70913933|NCT02982213|141318771|SUPERIORITY||Mean Difference (Net)|0.025||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.001
70913934|NCT02982213|141318775|EQUIVALENCE|Sample size of 5 per group to achieve 80% power to detect a change in the log odds ration of 1.0 at a .05 significance level using a two sided Mann Whitney U test.||||||0.001|TWO_SIDED|95.0|||||McNemar|||||||.001
70913935|NCT01549652|141318776|SUPERIORITY_OR_OTHER|||||||0.87||||||Students' t-tests for paired samples with Bonferroni correction for multiple comparisons were used to compare differences between the outcome measures for crossover treatment arms (placebo vs. ondansetron).|t-test, 2 sided|||For the purposes of our post-hoc power calculation we considered a 30% treatment effect clinically significant. Based on the mean observed OOWS score during withdrawal during the placebo session and the variance of that mean score and assuming a paired data analysis and an alpha of 0.05, we found that we had 80% power to detect a treatment effect as low as 25% reduction in OOWS.||||0.87
70913936|NCT01549652|141318777|SUPERIORITY_OR_OTHER|||||||0.92|||||||t-test, 2 sided|||||||0.92
70913937|NCT01549652|141318778|SUPERIORITY_OR_OTHER|||||||0.47|||||||t-test, 2 sided|||||||0.47
70913938|NCT01549652|141318779|SUPERIORITY_OR_OTHER|||||||0.91|||||||t-test, 2 sided|||||||0.91
70913939|NCT01549652|141318780|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70913940|NCT01549652|141318781|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
70913941|NCT01549652|141318782|SUPERIORITY_OR_OTHER|||||||0.6||||||Students' t-test for paired samples were used to compare differences between the outcome measures for treatment groups (placebo vs. ondansetron).|t-test, 2 sided|||We aimed for a 20% change in OOWS score to show the treatment effect with a power of 80% and an alpha of 0.05, yielding a target of 23 patients per treatment group.||||0.6
70913942|NCT01549652|141318783|SUPERIORITY_OR_OTHER|||||||0.2|||||||t-test, 2 sided|||||||0.20
70913943|NCT01549652|141318784|SUPERIORITY_OR_OTHER|||||||0.34|||||||t-test, 2 sided|||||||0.34
70913944|NCT01549652|141318785|SUPERIORITY_OR_OTHER|||||||0.4|||||||t-test, 2 sided|||||||0.40
70913945|NCT01549652|141318786|SUPERIORITY_OR_OTHER|||||||0.84|||||||t-test, 2 sided|||||||0.84
70913946|NCT01549652|141318787|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
70913947|NCT01972152|141318789|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||Mixed Models Analysis|Data were log transformed for analysis.||||||0.24
70913948|NCT01972152|141318790|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED|||||Data were log transformed for analysis.|Mixed Models Analysis|||||||0.34
70913949|NCT01972152|141318790|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||Data were log transformed for analysis.|Mixed Models Analysis|||||||0.01
70913950|NCT01972152|141318791|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||Mixed Models Analysis|||||||0.95
70913951|NCT01972152|141318792|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Mixed Models Analysis|||||||0.76
70913952|NCT01972152|141318793|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||Mixed Models Analysis|||||||0.68
70913953|NCT01972152|141318793|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|||||||0.02
70913954|NCT01972152|141318794|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Mixed Models Analysis|Data were log transformed for analysis||||||0.16
70913955|NCT01972152|141318795|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Data were log transformed for analysis||||||<0.001
70913956|NCT01972152|141318795|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Data were log transformed for analysis||||||<0.001
70913957|NCT01972152|141318796|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Data were log transformed for analysis||||||<0.001
71092887|NCT02127671|141692285|SUPERIORITY||Mean Difference (Net)|-10.5|||||TWO_SIDED|95.0|-18.4|-2.6||||||||-2.6|-18.4|
71153829|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.11||||0.58||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.58
71153830|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.13||||0.44||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.44
71153831|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.07||||0.75||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.75
71153832|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.04||||0.84||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.84
71153833|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.11||||0.67||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.67
71153834|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.002||||0.99||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.99
71153835|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.11||||0.62||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.62
71153836|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.17||||0.36||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.36
71153837|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.003||||0.99||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.99
71153838|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.2||||0.24||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.24
71153839|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.11||||0.62||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.62
71153840|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.08||||0.69||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for the analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.69
71153841|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.13||||0.6||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.60
71153842|NCT00488683|141800057|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.01||||0.95||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.95
71153843|NCT00488683|141800057|SUPERIORITY_OR_OTHER||R-square|0.0015||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||
71153844|NCT00488683|141800057|SUPERIORITY_OR_OTHER||R-square|0.0057||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||
70913958|NCT01972152|141318796|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Data were log transformed for analysis.|Mixed Models Analysis|||||||<0.001
71153845|NCT00488683|141800057|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||
71153846|NCT00488683|141800057|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear||Values from Groups 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||
70913959|NCT01972152|141318797|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
70913960|NCT01972152|141318797|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71153847|NCT00488683|141800057|SUPERIORITY_OR_OTHER||R-square|0.0048||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||
70913961|NCT00414648|141318804|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||The model included the time since enrollment, the treatment assignment, and the interaction between time and treatment.|Regression, Linear|Mixed model with the use of the Kenward-Roger correction without imputation of missing data.||FEV1 slope||||<0.001
70913962|NCT00414648|141318805|OTHER|||||||0.441|||||||Chi-squared|||||||.441
70913963|NCT00414648|141318806|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Regression, Linear|GLM adjusted for baseline||||||0.001
70913964|NCT00414648|141318807|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17|TWO_SIDED|95.0|||||Regression, Linear|GLM adjusted for baseline||||||0.17
70913965|NCT00414648|141318808|SUPERIORITY|||||||0.34|||||||Regression, Linear|GLM adjusted for baseline||||||0.34
70913966|NCT00414648|141318809|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88|||||||Regression, Linear|GLM adjusted for baseline||||||0.88
70913967|NCT00414648|141318810|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Regression, Linear|GLM adjusted for baseline||||||0.001
70913968|NCT01194258|141318811|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin was set at 0.40.|LS Mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.041||0.3876|TWO_SIDED|95.0|-0.12|0.05|||Mixed Models Analysis|||Approximately 110 participants were planned to be enrolled to allow approximately 88 participants to complete both treatment periods. Assuming a dropout rate of ≤20%, an intra-participant correlation of 0.80, a standard deviation of 1.2, and a true difference of 0, the study would have \>90% power to show that either Lispro-PH20 or Aspart-PH20 (each tested separately) was non-inferior to insulin lispro alone with respect to the change from baseline in A1C at the end of each treatment period.||0.05|-0.12|0.3876
70913969|NCT01726023|141318824|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority would be concluded if the lower limit of the 95% confidence interval (CI; corresponding to a 97.5% 1 sided lower bound) was greater than -12.5% for the primary outcome variable.|Risk Difference (RD)|-0.2|||<|0.001|TWO_SIDED|95.0|-5.53|4.97||P-value for 1-sided test at test of cure (TOC) with a -12.5% non-inferiority margin, i.e. H0: diff ≤ -12.5%.|% Risk Difference (RD)|RD is CAZ AVI clinical cure rate minus Meropenem clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|units for RD are %|The Primary objective of this study was to assess the non inferiority (based on a 12.5% margin) of CAZ AVI plus metronidazole compared to meropenem alone with respect to clinical cure at the TOC visit in patients who were CE.||4.97|-5.53|<0.001
70913970|NCT01726023|141318857|SUPERIORITY_OR_OTHER||Difference in median time (days)|0.5||||0.773|||||||Log Rank|||||||0.773
70913971|NCT01726023|141318858|SUPERIORITY_OR_OTHER||Difference in median time (days)|1.0||||0.598|||||||Log Rank|||||||0.598
70913972|NCT00816829|141318865|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.048
70913973|NCT00816829|141318866|SUPERIORITY_OR_OTHER|||||||0.203||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.203
70913974|NCT00816829|141318867|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between groups was performed using Wilcoxon Test on data at one month after the start of the treatment.||||0.007
70913975|NCT00816829|141318868|SUPERIORITY_OR_OTHER|||||||0.199||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.199
70913976|NCT00816829|141318869|SUPERIORITY_OR_OTHER|||||||0.114||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.114
70913977|NCT00816829|141318870|SUPERIORITY_OR_OTHER|||||||0.533||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.533
70913978|NCT00816829|141318871|SUPERIORITY_OR_OTHER|||||||0.521||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.521
70913979|NCT00816829|141318872|SUPERIORITY_OR_OTHER|||||||0.333||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.333
70913980|NCT00816829|141318873|SUPERIORITY_OR_OTHER|||||||0.264||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.264
70913981|NCT00816829|141318874|SUPERIORITY_OR_OTHER|||||||0.401||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.401
70913982|NCT03368001|141318908|OTHER|We used structural equation modeling (SEM), as implemented in Mplus 8.7, as a framework for testing all primary hypotheses. We accounted for any non-independence of observations due to cohort membership by obtaining cluster-robust standard errors using robust maximum likelihood estimation (MLR in Mplus) in tandem with the Type = Complex option available in Mplus, treating cohorts as clusters. All models were structurally saturated, so model fit was necessarily perfect.||||||0.039||||||IFM Posttest.|Structural Equation Modeling|We used structural equation modeling (SEM), as implemented in Mplus 8.7, as a framework for testing all primary hypotheses.||Population models were specified using parameter values derived from past research in tandem with minimal expected effect sizes for the effects of most interest. These models were used to generate 5000 samples for a given N, the models were fit to each sample, and the significance (or not) of key effects was noted. This process was repeated until the target power of at least .80 was reached indicating with 216 participants we would have .82 power.||||.039
70913983|NCT03368001|141318908|OTHER|The residuals associated with the mediator and outcome were allowed to covary with the lag and pretest scores associated with the outcome, and the residual associated with the outcome was allowed to covary with the lag and pretest scores associated with the mediator.|Structural Equation Model (SEM)|0.064|||<|0.05|TWO_SIDED|90.0|0.014|0.118||One-tailed significance test|Structural Equation Model (SEM)|Controlling for Verbal Expressiveness at Pretest and the interval between Pretest and the Followup assessments.|Estimation parameter represents indirect effect (axb)|The indirect effect of SENSE Theatre® vs. TTT through post-test IFM on follow-up Vocal Expressiveness. We adjusted standard errors for cohort, controlled the mediator for individual differences in lag between pretest and posttest for the a path and controlled the outcome for individual differences in lag between pretest to follow-up for the b and c' paths.||0.118|0.014|<0.05
71092888|NCT02127671|141692286|SUPERIORITY||Mean Difference (Net)|-1.8|||||TWO_SIDED|95.0|-5.1|1.5||||||systolic||1.5|-5.1|
71092889|NCT02127671|141692286|SUPERIORITY||Mean Difference (Net)|-1.7|||||TWO_SIDED|95.0|-3.8|0.5||||||diastolic||0.5|-3.8|
70913984|NCT03368001|141318908|OTHER|The residual associated with the mediator was allowed to covary with the lag and pretest scores associated with the outcome, and the residual associated with the outcome was allowed to covary with the lag and pretest scores associated with the mediator, yielding a saturated model.|Structural Equation Model (SEM)|0.032|||<|0.05|TWO_SIDED|90.0|0.002|0.087||One-sided hypothesis test.|Structural Equation Model (SEM)|Controlling for Rapport at Pretest and the interval between Pretest and the Followup assessments.|Estimation parameter represents indirect effect (axb)|The partially standardized indirect effect of treatment on follow-up Quality of Rapport through posttest Incidental Face Memory. We adjusted standard errors for cohort, controlled the mediator for individual differences in lag (pretest to posttest) and baseline mediator, and controlled the outcome for individual differences in lag (pretest to follow-up) and baseline outcome.||0.087|0.002|<0.05
70913985|NCT03368001|141318908|OTHER|The residuals associated with the mediator and outcome were allowed to covary with the lag and pretest scores associated with the outcome, and the residual associated with the outcome was allowed to covary with the lag and pretest scores associated with the mediator, yielding a saturated model.|Structural Equation Model (SEM)|0.005|||>|0.05|TWO_SIDED|90.0|-0.015|0.059||One-sided hypothesis test|Structural Equation Model (SEM)|Controlling for Social Anxiety at Pretest and the interval between Pretest and the Followup assessments.|Estimation parameter represents indirect effect (axb)|The partially standardized indirect effect of treatment on follow-up Social Anxiety through posttest IFM. Adjusted standard errors for cohort, controlled the mediator for individual differences in lag between pretest and posttest for the a path and controlled the outcome for individual differences in lag between pretest to follow-up for the b and c' paths.||0.059|-0.015|>0.05
70913986|NCT03368001|141318908|OTHER|The residuals associated with the mediator and outcome were allowed to covary with the lag and pretest scores associated with the outcome, and the residual associated with the outcome was allowed to covary with the lag and pretest scores associated with the mediator, yielding a saturated model.|Structural Equation Model (SEM)|-0.0002|||>|0.05|TWO_SIDED|90.0|-0.054|0.061||One-sided hypothesis test|Structural Equation Model (SEM)|Controlling for SRS-2 Social Communication at Pretest and the interval between Pretest and the Followup assessments.|Estimation parameter represents indirect effect (axb)|The partially standardized indirect effect of treatment on follow-up SRS Communication. We adjusted standard errors for cohort, controlled the mediator for individual differences in lag between pretest and posttest for the a path and controlled the outcome for individual differences in lag between pretest to follow-up for the b and c' paths.||0.061|-0.054|>0.05
70913987|NCT03368001|141318909|OTHER|||||||0.49||||||SRS Communication Posttest.|Structural Equation Modeling|We used structural equation modeling (SEM), as implemented in Mplus 8.7, as a framework for testing all primary hypotheses.||||||.490
70913988|NCT03368001|141318910|OTHER|Posttest ANCOVA controlling for pre-test scores||||||0.704|||||||ANCOVA|||||||0.704
70913989|NCT03368001|141318910|OTHER|Followup ANCOVA controlling for pretest values||||||0.406|||||||ANCOVA|||||||0.406
70913990|NCT03368001|141318911|OTHER|||||||0.217|||||||Structural Equation Modeling|We used structural equation modeling (SEM), as implemented in Mplus 8.7, as a framework for testing all primary hypotheses.||Vocal Expressiveness Posttest.||||.217
70913991|NCT03368001|141318911|OTHER|||||||0.448|||||||Structural Equation Modeling|We used structural equation modeling (SEM), as implemented in Mplus 8.7, as a framework for testing all primary hypotheses||Quality of Rapport Posttest.||||.448
70913992|NCT03368001|141318911|OTHER|||||||0.15|||||||Structural Equation Modeling|We used structural equation modeling (SEM), as implemented in Mplus 8.7, as a framework for testing all primary hypotheses||Social Anxiety Posttest.||||.150
70913993|NCT03368001|141318912|OTHER|Posttest ANCOVA controlling for pre-test values||||||0.169|||||||ANCOVA|||||||0.169
70913994|NCT03368001|141318912|OTHER|Followup ANCOVA controlling for pretest values.||||||0.555|||||||ANCOVA|||||||0.555
70913995|NCT02317016|141318935|NON_INFERIORITY_OR_EQUIVALENCE|No effect on the PK of rosuvastatin after co-administration of AZD9291 was concluded if the 2-sided 90% confidence intervals (CIs) for the ratios of rosuvastatin AUC and Cmax were within the range of 70% to 143%.|Geometric least-squares (LS) mean ratio|171.92|||||TWO_SIDED|90.0|145.94|202.53|||||AZD9291+ rosuvastatin / rosuvastatin alone (Day 32 versus Day 1).|Natural log-transformed Cmax values were compared between treatments using a mixed effects analysis of variance (ANOVA) with treatment as a fixed effect and patient as a random effect. It was assumed the within-patient coefficient of variation for rosuvastatin in both area under the plasma concentration-time curve (AUC) and Cmax was 41%. No change in the exposure for rosuvastatin when given with AZD9291 was also assumed.||202.53|145.94|
70913996|NCT02317016|141318936|NON_INFERIORITY_OR_EQUIVALENCE|No effect on the PK of rosuvastatin after co-administration of AZD9291 was concluded if the 2-sided 90% CIs for the ratios of rosuvastatin AUC and Cmax were within the range of 70% to 143%.|Geometric LS Mean Ratio|134.63|||||TWO_SIDED|90.0|115.41|157.07|||||AZD9291+ rosuvastatin / rosuvastatin alone (Day 32 versus Day 1).|Natural log-transformed AUC values were compared between treatments using a mixed effects ANOVA with treatment as a fixed effect and patient as a random effect. It was assumed the within-patient coefficient of variation for rosuvastatin in both AUC and Cmax was 41%. No change in the exposure for rosuvastatin when given with AZD9291 was also assumed.||157.07|115.41|
70913997|NCT00536380|141318949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.721||95.0|||||ANCOVA|||||||0.721
70913998|NCT03693742|141318952|SUPERIORITY||||||<|0.001||||||A P value of less than 0.05 was considered significant.|Mixed Models Analysis|||"Null hypothesis is that there was no difference in uptake of F18-DCFPyL between the MSG and placebo groups.~A sample size of 10 achieves 100% power to detect a mean of paired differences of 5.0 (33%) with an estimated standard deviation of differences of 1.0 and with a significance level (alpha) of 0.05 using a one-sided paired t-test. If the estimated standard deviation of differences is 5.0, a sample size of 10 achieves 90% power to detect a mean difference of 5.0 with an alpha of 0.05."||||<0.001
70913999|NCT02931396|141318956|SUPERIORITY||Mean Difference (Net)|2.3||||0.768|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.768
70970679|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|5.0362|STANDARD_ERROR_OF_MEAN|3.3182||0.1356|TWO_SIDED|80.0|0.72505|9.3473|||Mixed Models Analysis|||Week 3 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||9.3473|0.72505|0.1356
70970680|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|5.1569|STANDARD_ERROR_OF_MEAN|16.2884||0.7528|TWO_SIDED|80.0|-15.99|26.303|||Mixed Models Analysis|||Week 3 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||26.303|-15.99|0.7528
71092890|NCT02127671|141692288|SUPERIORITY||Mean Difference (Net)|-4.3|||||TWO_SIDED|95.0|-13.3|4.7||||||||4.7|-13.3|
71092891|NCT02127671|141692289|SUPERIORITY||Mean Difference (Net)|-5.4|||||TWO_SIDED|95.0|-12.7|2.0||||||||2.0|-12.7|
70914000|NCT02931396|141318957|SUPERIORITY||Mean Difference (Net)|25.5||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1
70914001|NCT02931396|141318958|SUPERIORITY||Mean Difference (Net)|2.7||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.03
70914002|NCT04341298|141319008|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
70914003|NCT04341298|141319009|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||||||0.87
70914004|NCT04341298|141319010|SUPERIORITY|||||||0.66|||||||Mantel Haenszel|Subjects were stratified based on baseline pain score (6-7 vs. 8-10) prior to analysis using Cochran-Mantel-Haenszel test||Each subject was stratified by baseline pain score for the first severe headache that they experienced (score of 6-7 vs. 8-10). The total number of subjects, and the number of subjects with a pain score of 3 or less after 2 hours, were tabulated within each stratum. A Cochran-Mantel-Haenszel test was conducted to test the hypothesis of lack of association between the proportion of subjects reporting mild or no symptoms after 2 hours and the type of device, across all strata.||||0.66
70914005|NCT04341298|141319011|SUPERIORITY|||||||0.59|||||||Mantel Haenszel|Subjects were stratified based on baseline pain score (6-7 vs. 8-10) prior to analysis using Cochran-Mantel-Haenszel test||Each subject was stratified by baseline pain score for the first severe headache that they experienced (score of 6-7 vs. 8-10). The total number of subjects, and the number of subjects requiring abortive medication within 8 hours were tabulated within each stratum. A Cochran-Mantel-Haenszel test was conducted to test the hypothesis of lack of association between the proportion of subjects requiring abortive medication within 8 hours and the type of device, across all strata.||||0.59
70914006|NCT04341298|141319012|SUPERIORITY|||||||0.19|||||||Mantel Haenszel|Subjects were stratified based on baseline pain score (6-7 vs. 8-10) prior to analysis using Cochran-Mantel-Haenszel test||Each subject was stratified by baseline pain score for the first severe headache that they experienced (score of 6-7 vs. 8-10). The total number of subjects, and the number of subjects experiencing light sensitivity after 2 hours, were tabulated within each stratum. A Cochran-Mantel-Haenszel test was conducted to test the hypothesis of lack of association between the proportion of subjects reporting light sensitivity after 2 hours and the type of device, across all strata.||||0.19
70914007|NCT04341298|141319013|SUPERIORITY|||||||1|||||||Mantel Haenszel|Subjects were stratified based on baseline pain score (6-7 vs. 8-10) prior to analysis using Cochran-Mantel-Haenszel test||Each subject was stratified by baseline pain score for the first severe headache that they experienced (score of 6-7 vs. 8-10). The total number of subjects, and the number of subjects experiencing light sensitivity after 4 hours, were tabulated within each stratum. A Cochran-Mantel-Haenszel test was conducted to test the hypothesis of lack of association between the proportion of subjects reporting light sensitivity after 4 hours and the type of device, across all strata.||||1.0
70914008|NCT04341298|141319014|SUPERIORITY|||||||0.021|||||||Mixed Models Analysis|Pain score difference after 2 hours modeled as a function of study arm, baseline pain score and headache medication use.||Null hypothesis is that 2 hour difference in pain score is equivalent between study arms, after adjusting for baseline pain score and headache medication use.||||0.021
70914009|NCT04341298|141319015|SUPERIORITY|||||||0.019|||||||Mixed Models Analysis|Pain score difference after 4 hours modeled as a function of study arm, baseline pain score and headache medication use.||Null hypothesis is that 4 hour difference in pain score is equivalent between study arms, after adjusting for baseline pain score and headache medication use.||||0.019
70914010|NCT04341298|141319016|SUPERIORITY|Null hypothesis is that proportion of headaches with light sensitivity experienced after 2 hours is equivalent between study arms, after adjusting for baseline pain score and headache medication use.||||||0.028|||||||Mixed Models Analysis|Proportion of headaches with light sensitivity after 2 hours modeled as a function of study arm, baseline pain score and headache medication use.||||||0.028
70914011|NCT04341298|141319017|SUPERIORITY|||||||0.46|||||||Mixed Models Analysis|Proportion of headaches with light sensitivity after 4 hours modeled as a function of study arm, baseline pain score and headache medication use.||Null hypothesis is that proportion of headaches with light sensitivity experienced after 4 hours is equivalent between study arms, after adjusting for baseline pain score and headache medication use.||||0.46
70914012|NCT00646451|141319111|SUPERIORITY_OR_OTHER_LEGACY|||||||0.162|||||||ANOVA|||"Outcome on study completers was assessed via ANOVA models using a 2 × 2 Latin-square crossover design including sequence, period, and treatment effects. A significant carryover effect was excluded. Analyses were performed using Stata IC version 10.0 for Windows.~Unfortunately the small sample size of our study limits the possibility of a meaningful post-hoc analysis targeted to these variables."|The Quest rates patient perception of health status as influenced by tremor across 5 domains, physical, psychosocial, communication, hobbies/leisure, and work/finance. HAM-A rates severity of anxiety symptomatology across 14 parameters. Scores of 14-17 correspond to mild anxiety, scores of 18-24 is moderate anxiety and 25-30 severe anxiety. HD-16 rates insomnia-related QoL across 5 domains: physical symptoms, energy \& motivation, concentration, interpersonal relations and psychological symptoms. These scales were scored per published guidelines.|||0.162
70914013|NCT01362491|141319112|SUPERIORITY_OR_OTHER||Least-Square (LS) mean difference|6.11|||<|0.001|TWO_SIDED|95.0|4.49|7.73||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms.|ANOVA|||Treatment difference (Ibuprofen sodium-placebo) and 95 percent (%) confidence interval (CI): based on LS means from analysis of variance (ANOVA). Type I error was controlled at 0.05 significance level (2-sided) by declaring pair wise comparisons significant only if overall treatment effect among 3 treatment groups was significant and testing in a sequential order Ibuprofen sodium versus (vs.) placebo for SPRID 0-3 then Ibuprofen sodium vs. Ibuprofen (Motrin IB) for time to meaningful relief.||7.73|4.49|<0.001
71092892|NCT02127671|141692290|SUPERIORITY||Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|-1.8|3.8||||||||3.8|-1.8|
71092893|NCT02127671|141692291|SUPERIORITY||Mean Difference (Net)|8.1|||||TWO_SIDED|95.0|-13.4|29.6||||||||29.6|-13.4|
71092894|NCT03834168|141692303|OTHER|||||||0.003|||||||Regression (Cosinor Fit)|||||||0.003
71092895|NCT03834168|141692303|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||||||<0.001
71092896|NCT00782067|141692306|OTHER|Single arm study|||||<|0.001|TWO_SIDED|95.0||||Null hypothesis: ORR \<= 30% Alternative hypothesis: ORR \>= 50%|Exact Binomial Test||||Exact Binomial 95% Confidence Interval|||<0.001
71092897|NCT03556683|141692313|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Effect immediately following hypertonic saline treatment.||||<0.001
71092898|NCT03556683|141692314|SUPERIORITY|||||||0.99|||||||Mixed Models Analysis|||Effect of hypertonic saline 4 hours after treatment.||||0.99
71092899|NCT00764517|141692319|OTHER||Hazard Ratio (HR)|0.33||||0.002|TWO_SIDED|95.0|0.16|0.69|||Log Rank|||||0.69|0.16|0.002
71092900|NCT00764517|141692320|OTHER||Hazard Ratio (HR)|0.42||||0.011|TWO_SIDED|95.0|0.21|0.84|||Log Rank|||||0.84|0.21|0.011
71092901|NCT00621530|141692338|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.94|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Power calculation assumed that all subjects would have an area of hypersensitivity surrounding the wound at 48 hours. We found that only 1 subject in the placebo group and 3 subjects in the ketorolac group had non-zero areas of hypersensitivity.||||=0.94
71092902|NCT00621530|141692339|SUPERIORITY||||||=|0.78|||||||ANOVA|Repeated measures ANOVA||||||=0.78
71092903|NCT00621530|141692340|SUPERIORITY||||||=|0.87|||||||ANOVA|Repeated measures ANOVA||||||=0.87
71092904|NCT00621530|141692341|SUPERIORITY||||||=|0.66|||||||ANOVA|Repeated measures ANOVA||||||=0.66
71092905|NCT00621530|141692342|SUPERIORITY||||||=|0.83|||||||ANOVA|Repeated measures ANOVA||||||=0.83
71092906|NCT00671060|141692350|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.682|||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||Rates of success were compared across study arms. The study was a separate, non-comparative efficacy study. In order to have 80% power (alpha=.05) to demonstrate that each misoprostol regimen was 95%, ± 5%, effective, we enrolled 73 women in each arm of the study, or 146 women total. The sample size also provided 80% power (alpha=.05) to detect a significant difference between treatments should 200μg prove 98% effective and 100μg prove 88% effective.||||<0.05
71092907|NCT02107898|141692359|SUPERIORITY_OR_OTHER||LS Mean Difference|-64.1|||<|0.0001|TWO_SIDED|95.0|-68.5|-59.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-59.8|-68.5|<0.0001
71092908|NCT02107898|141692360|SUPERIORITY_OR_OTHER||LS Mean Difference|-65.3|||<|0.0001|TWO_SIDED|95.0|-69.4|-61.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-61.3|-69.4|<0.0001
71092909|NCT02107898|141692361|SUPERIORITY_OR_OTHER||LS Mean Difference|-61.5|||<|0.0001|TWO_SIDED|95.0|-65.3|-57.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-57.7|-65.3|<0.0001
71092910|NCT02107898|141692362|SUPERIORITY_OR_OTHER||LS Mean Difference|-62.1|||<|0.0001|TWO_SIDED|95.0|-65.8|-58.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-58.3|-65.8|<0.0001
71092911|NCT02107898|141692363|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.3|||<|0.0001|TWO_SIDED|95.0|-57.5|-49.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-49.1|-57.5|<0.0001
71092912|NCT02107898|141692364|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.8|||<|0.0001|TWO_SIDED|95.0|-57.8|-49.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-49.8|-57.8|<0.0001
71092913|NCT02107898|141692365|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.5|||<|0.0001|TWO_SIDED|95.0|-61.5|-53.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-53.5|-61.5|<0.0001
71092914|NCT02107898|141692366|SUPERIORITY_OR_OTHER||LS Mean Difference|-58.6|||<|0.0001|TWO_SIDED|95.0|-62.3|-54.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-54.8|-62.3|<0.0001
71092915|NCT02107898|141692367|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.5|||<|0.0001|TWO_SIDED|95.0|-44.6|-38.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-38.4|-44.6|<0.0001
71092916|NCT02107898|141692368|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.2|||<|0.0001|TWO_SIDED|95.0|-54.9|-47.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-47.6|-54.9|<0.0001
71092917|NCT02107898|141692369|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.5|||<|0.0001|TWO_SIDED|95.0|-57.9|-51.1|||Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-51.1|-57.9|<0.0001
71092918|NCT02107898|141692370|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.0|||<|0.0001|TWO_SIDED|95.0|-41.7|-36.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-36.4|-41.7|<0.0001
71092919|NCT02107898|141692371|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|552.1|||<|0.0001|TWO_SIDED|95.0|105.6|2886.8||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||2886.8|105.6|<0.0001
71092920|NCT02107898|141692372|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1367.8|||<|0.0001|TWO_SIDED|95.0|137.8|13578.3||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||13578.3|137.8|<0.0001
71153848|NCT00488683|141800057|SUPERIORITY_OR_OTHER||R-square|0.0018||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||
70914014|NCT01362491|141319113|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.253|TWO_SIDED|95.0|0.88|1.65||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms.|Proportional hazards model|||Hazard Ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model. Type I error was controlled at 0.05 significance level (2-sided) by declaring pair wise comparisons significant only if overall treatment effect among 3 treatment groups was significant and testing in a sequential order Ibuprofen sodium vs. placebo for SPRID 0-3 then Ibuprofen sodium vs. Ibuprofen (Motrin IB) for time to meaningful relief.||1.65|0.88|0.253
70914015|NCT01362491|141319114|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.38|||<|0.001|TWO_SIDED|95.0|2.69|7.14||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||7.14|2.69|<0.001
71153849|NCT00488683|141800057|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||
70914016|NCT01362491|141319114|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.64|||<|0.001|TWO_SIDED|95.0|2.23|5.94||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||5.94|2.23|<0.001
70914017|NCT01362491|141319115|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.68|||<|0.001|TWO_SIDED|95.0|2.87|7.64||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||7.64|2.87|<0.001
70914018|NCT01362491|141319115|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.88|||<|0.001|TWO_SIDED|95.0|2.38|6.34||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||6.34|2.38|<0.001
70914019|NCT01362491|141319115|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||0.247|TWO_SIDED|95.0|0.88|1.66||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.66|0.88|0.247
70914020|NCT01362491|141319116|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.26|||<|0.001|TWO_SIDED|95.0|0.92|1.59||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.59|0.92|<0.001
70914021|NCT01362491|141319116|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.27|||<|0.001|TWO_SIDED|95.0|0.93|1.61||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.61|0.93|< 0.001
70914022|NCT01362491|141319116|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.01||||0.943|TWO_SIDED|95.0|-0.29|0.27||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.27|-0.29|0.943
70914023|NCT01362491|141319116|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.25|||<|0.001|TWO_SIDED|95.0|0.89|1.62||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.62|0.89|<0.001
70914024|NCT01362491|141319116|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.22|||<|0.001|TWO_SIDED|95.0|0.85|1.59||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.59|0.85|<0.001
70914025|NCT01362491|141319116|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.03||||0.847|TWO_SIDED|95.0|-0.27|0.33||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.33|-0.27|0.847
70914026|NCT01362491|141319116|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.59|||<|0.001|TWO_SIDED|95.0|1.14|2.05||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.05|1.14|<0.001
70914027|NCT01362491|141319116|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.68|||<|0.001|TWO_SIDED|95.0|1.22|2.13||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.13|1.22|<0.001
70914028|NCT01362491|141319116|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.08||||0.663|TWO_SIDED|95.0|-0.46|0.29||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - (Ibuprofen IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.29|-0.46|0.663
70970681|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|67.7022|STANDARD_ERROR_OF_MEAN|17.4066||0.0003|TWO_SIDED|80.0|45.114|90.29|||Mixed Models Analysis|||Week 3 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||90.290|45.114|0.0003
70914029|NCT01362491|141319117|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.54|||<|0.001|TWO_SIDED|95.0|0.37|0.72||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.72|0.37|<0.001
70914030|NCT01362491|141319117|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.51|||<|0.001|TWO_SIDED|95.0|0.33|0.69||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.69|0.33|<0.001
70914031|NCT01362491|141319117|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.03||||0.651|TWO_SIDED|95.0|-0.11|0.18||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.18|-0.11|0.651
70914032|NCT01362491|141319117|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.62|||<|0.001|TWO_SIDED|95.0|0.42|0.81||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.81|0.42|<0.001
70914033|NCT01362491|141319117|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.65|||<|0.001|TWO_SIDED|95.0|0.46|0.85||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.85|0.46|<0.001
70914034|NCT01362491|141319117|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.03||||0.669|TWO_SIDED|95.0|-0.19|0.13||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.13|-0.19|0.669
70914035|NCT01362491|141319117|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.84|||<|0.001|TWO_SIDED|95.0|0.57|1.11||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.11|0.57|<0.001
70914036|NCT01362491|141319117|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.94|||<|0.001|TWO_SIDED|95.0|0.67|1.21||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.21|0.67|<0.001
70914037|NCT01362491|141319117|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.1||||0.396|TWO_SIDED|95.0|-0.32|0.13||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.13|-0.32|0.396
70970682|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|2.8582|STANDARD_ERROR_OF_MEAN|2.6389||0.2837|TWO_SIDED|80.0|-0.567|6.2835|||Mixed Models Analysis|||Week 3 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.2835|-0.5670|0.2837
70914038|NCT01362491|141319118|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.8|||<|0.001|TWO_SIDED|95.0|1.3|2.3||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.30|1.30|<0.001
70914039|NCT01362491|141319118|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.78|||<|0.001|TWO_SIDED|95.0|1.28|2.28||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.28|1.28|<0.001
70914040|NCT01362491|141319118|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.02||||0.911|TWO_SIDED|95.0|-0.39|0.43||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.43|-0.39|0.911
70914041|NCT01362491|141319118|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.87|||<|0.001|TWO_SIDED|95.0|1.33|2.41||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.41|1.33|<0.001
70914042|NCT01362491|141319118|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.88|||<|0.001|TWO_SIDED|95.0|1.34|2.42||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.42|1.34|<0.001
70914043|NCT01362491|141319118|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.0||||0.982|TWO_SIDED|95.0|-0.45|0.44||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.44|-0.45|0.982
70970683|NCT00531752|141447061|SUPERIORITY_OR_OTHER||LS Mean Difference|12.9251|STANDARD_ERROR_OF_MEAN|2.8913|<|0.0001|TWO_SIDED|80.0|9.1761|16.674|||Mixed Models Analysis|||Week 3 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||16.674|9.1761|<0.0001
70970684|NCT00531752|141447062|SUPERIORITY_OR_OTHER||LS Mean Difference|26.8615|STANDARD_ERROR_OF_MEAN|3.9167|<|0.0001|TWO_SIDED|80.0|21.777|31.946|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||31.946|21.777|<0.0001
70970685|NCT00531752|141447062|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3455|STANDARD_ERROR_OF_MEAN|4.1817||0.3034|TWO_SIDED|80.0|-1.08|9.7713|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||9.7713|-1.080|0.3034
70914044|NCT01362491|141319118|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|2.44|||<|0.001|TWO_SIDED|95.0|1.72|3.15||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.15|1.72|<0.001
70914045|NCT01362491|141319118|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|2.61|||<|0.001|TWO_SIDED|95.0|1.9|3.33||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.33|1.90|<0.001
70914046|NCT01362491|141319118|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.18||||0.547|TWO_SIDED|95.0|-0.77|0.41||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.41|-0.77|0.547
70914047|NCT01362491|141319119|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.16|||<|0.001|TWO_SIDED|95.0|0.83|1.5||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.50|0.83|<0.001
70914048|NCT01362491|141319119|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.17|||<|0.001|TWO_SIDED|95.0|0.83|1.5||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.50|0.83|<0.001
70914049|NCT01362491|141319119|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.0||||0.992|TWO_SIDED|95.0|-0.28|0.27||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.27|-0.28|0.992
70914050|NCT01362491|141319119|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|2.01|||<|0.001|TWO_SIDED|95.0|1.43|2.58||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.58|1.43|<0.001
70970686|NCT00531752|141447062|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9558|STANDARD_ERROR_OF_MEAN|2.9408||0.0223|TWO_SIDED|80.0|3.132|10.78|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||10.780|3.1320|0.0223
70914051|NCT01362491|141319119|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|2.1|||<|0.001|TWO_SIDED|95.0|1.53|2.68||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.68|1.53|<0.001
70914052|NCT01362491|141319119|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.1||||0.684|TWO_SIDED|95.0|-0.57|0.38||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.38|-0.57|0.684
70914053|NCT01362491|141319120|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|2.51|||<|0.001|TWO_SIDED|95.0|1.85|3.17||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Ibuprofen Sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.17|1.85|<0.001
70914054|NCT01362491|141319120|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|2.49|||<|0.001|TWO_SIDED|95.0|1.83|3.15||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference \[Ibuprofen (Motrin IB) - Placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.15|1.83|<0.001
70914055|NCT01362491|141319120|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.02||||0.943|TWO_SIDED|95.0|-0.52|0.56||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.56|-0.52|0.943
70914056|NCT01362491|141319120|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|4.1|||<|0.001|TWO_SIDED|95.0|3.03|5.18||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Ibuprofen Sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||5.18|3.03|<0.001
70914057|NCT01362491|141319120|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|4.17|||<|0.001|TWO_SIDED|95.0|3.09|5.24||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference \[Ibuprofen (Motrin IB) - Placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||5.24|3.09|<0.001
71092921|NCT02107898|141692373|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-42.0|||<|0.0001|TWO_SIDED|95.0|-48.0|-36.0||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-36.0|-48.0|<0.0001
70914058|NCT01362491|141319120|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.06||||0.888|TWO_SIDED|95.0|-0.95|0.82||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.82|-0.95|0.888
70914059|NCT01362491|141319121|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|3.67|||<|0.001|TWO_SIDED|95.0|2.71|4.64||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Ibuprofen Sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.64|2.71|<0.001
70914060|NCT01362491|141319121|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|3.66|||<|0.001|TWO_SIDED|95.0|2.68|4.63||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.63|2.68|<0.001
70914061|NCT01362491|141319121|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.02||||0.964|TWO_SIDED|95.0|-0.78|0.82||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.82|-0.78|0.964
70914062|NCT01362491|141319121|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|6.27|||<|0.001|TWO_SIDED|95.0|4.65|7.89||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||7.89|4.65|<0.001
70914063|NCT01362491|141319121|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.16||||0.812|TWO_SIDED|95.0|-1.49|1.17||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.17|-1.49|0.812
70914064|NCT01362491|141319122|SUPERIORITY_OR_OTHER||Difference in proportion|12.02||||0.015|TWO_SIDED|95.0|5.27|18.77||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.77|5.27|0.015
70914065|NCT01362491|141319122|SUPERIORITY_OR_OTHER||Difference in proportion|4.5||||0.146|TWO_SIDED|95.0|0.13|8.88||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.88|0.13|0.146
70914066|NCT01362491|141319122|SUPERIORITY_OR_OTHER||Difference in proportion|7.62||||0.064|TWO_SIDED|95.0|-0.38|15.63||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.63|-0.38|0.064
70914067|NCT01362491|141319122|SUPERIORITY_OR_OTHER||Difference in proportion|58.58|||<|0.001|TWO_SIDED|95.0|44.96|72.21||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||72.21|44.96|<0.001
70914068|NCT01362491|141319122|SUPERIORITY_OR_OTHER||Difference in proportion|52.31|||<|0.001|TWO_SIDED|95.0|38.2|66.41||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||66.41|38.20|<0.001
70914069|NCT01362491|141319122|SUPERIORITY_OR_OTHER||Difference in proportion|6.4||||0.357|TWO_SIDED|95.0|-7.27|20.07||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.07|-7.27|0.357
70914070|NCT01362491|141319122|SUPERIORITY_OR_OTHER||Difference in proportion|46.68|||<|0.001|TWO_SIDED|95.0|30.43|62.93||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||62.93|30.43|<0.001
70914071|NCT01362491|141319122|SUPERIORITY_OR_OTHER||Difference in proportion|47.59|||<|0.001|TWO_SIDED|95.0|31.35|63.83||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||63.83|31.35|<0.001
70914072|NCT01362491|141319122|SUPERIORITY_OR_OTHER||Difference in proportion|-0.72||||0.889|TWO_SIDED|95.0|-10.89|9.45||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.45|-10.89|0.889
70914073|NCT01362491|141319122|SUPERIORITY_OR_OTHER||Difference in proportion|40.26|||<|0.001|TWO_SIDED|95.0|23.85|56.68||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||56.68|23.85|<0.001
70914074|NCT01362491|141319122|SUPERIORITY_OR_OTHER||Difference in proportion|41.19|||<|0.001|TWO_SIDED|95.0|24.78|57.59||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||57.59|24.78|<0.001
70914075|NCT01362491|141319122|SUPERIORITY_OR_OTHER||Difference in proportion|-0.72||||0.889|TWO_SIDED|95.0|-10.89|9.45||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.45|-10.89|0.889
70914076|NCT01362491|141319123|SUPERIORITY_OR_OTHER||Difference in proportion|18.58||||0.002|TWO_SIDED|95.0|10.43|26.73||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||26.73|10.43|0.002
70914077|NCT01362491|141319123|SUPERIORITY_OR_OTHER||Difference in proportion|7.8||||0.055|TWO_SIDED|95.0|2.14|13.46||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.46|2.14|0.055
70914078|NCT01362491|141319123|SUPERIORITY_OR_OTHER||Difference in proportion|10.91||||0.033|TWO_SIDED|95.0|0.98|20.83||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.83|0.98|0.033
70914079|NCT01362491|141319123|SUPERIORITY_OR_OTHER||Difference in proportion|62.03|||<|0.001|TWO_SIDED|95.0|48.65|75.41||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||75.41|48.65|<0.001
70914080|NCT01362491|141319123|SUPERIORITY_OR_OTHER||Difference in proportion|59.44|||<|0.001|TWO_SIDED|95.0|45.69|73.19||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||73.19|45.69|<0.001
70914081|NCT01362491|141319123|SUPERIORITY_OR_OTHER||Difference in proportion|2.96||||0.642|TWO_SIDED|95.0|-9.52|15.44||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.44|-9.52|0.642
70914082|NCT01362491|141319123|SUPERIORITY_OR_OTHER||Difference in proportion|40.26|||<|0.001|TWO_SIDED|95.0|23.85|56.68||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||56.68|23.85|<0.001
70914083|NCT01362491|141319123|SUPERIORITY_OR_OTHER||Difference in proportion|41.19|||<|0.001|TWO_SIDED|95.0|24.78|57.59||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||57.59|24.78|<0.001
71092922|NCT02107898|141692374|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-22.0|||<|0.0001|TWO_SIDED|95.0|-30.9|-13.1||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-13.1|-30.9|<0.0001
70914084|NCT01362491|141319123|SUPERIORITY_OR_OTHER||Difference in proportion|-0.72||||0.889|TWO_SIDED|95.0|-10.89|9.45||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.45|-10.89|0.889
70914085|NCT01362491|141319123|SUPERIORITY_OR_OTHER||Difference in proportion|40.26|||<|0.001|TWO_SIDED|95.0|23.85|56.68||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||56.68|23.85|<0.001
70914086|NCT01362491|141319123|SUPERIORITY_OR_OTHER||Difference in proportion|41.19|||<|0.001|TWO_SIDED|95.0|24.78|57.59||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||57.59|24.78|<0.001
70914087|NCT01362491|141319123|SUPERIORITY_OR_OTHER||Difference in proportion|-0.72||||0.889|TWO_SIDED|95.0|-10.89|9.45||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.45|-10.89|0.889
70914088|NCT01362491|141319126|SUPERIORITY_OR_OTHER||Difference in proportion|3.21||||0.389|TWO_SIDED|95.0|-3.12|9.55||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen Sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.55|-3.12|0.389
70914089|NCT01362491|141319126|SUPERIORITY_OR_OTHER||Difference in proportion|2.35||||0.49|TWO_SIDED|95.0|-3.69|8.39||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.39|-3.69|0.490
70914090|NCT01362491|141319126|SUPERIORITY_OR_OTHER||Difference in proportion|0.98||||0.764|TWO_SIDED|95.0|-5.45|7.41||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||7.41|-5.45|0.764
70914091|NCT01362491|141319126|SUPERIORITY_OR_OTHER||Difference in proportion|28.71|||<|0.001|TWO_SIDED|95.0|15.72|41.7||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen Sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||41.70|15.72|<0.001
70914092|NCT01362491|141319126|SUPERIORITY_OR_OTHER||Difference in proportion|29.37|||<|0.001|TWO_SIDED|95.0|16.19|42.56||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||42.56|16.19|<0.001
70914093|NCT01362491|141319126|SUPERIORITY_OR_OTHER||Difference in proportion|-0.93||||0.898|TWO_SIDED|95.0|-15.22|13.36||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.36|-15.22|0.898
70914094|NCT01249092|141319134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-57.3|STANDARD_DEVIATION|62.1||0.001|TWO_SIDED|95.0|-88.2|-26.4||This study tested the hypothesis that treatment with pentoxifylline would result in a statistically significant change from baseline in the level of alkaline phosphatase.|Paired t-test|||A p-value \< 0.05 was considered statistically significant and all analyses were carried out using SAS version 9.2 (The SAS Institute, Cary, NC). Matched pairs t-test was used to compare the change in alkaline phosphatase from baseline. The efficacy of therapy was measured based on improvement in AP levels after therapy with PTX. AP levels at end of the study were compared with values at baseline by matched pairs t-test.||-26.4|-88.2|0.001
71092923|NCT02107898|141692375|SUPERIORITY_OR_OTHER||LS Mean Difference|5.8||||0.002|TWO_SIDED|95.0|2.1|9.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||9.4|2.1|0.0020
70914095|NCT01249092|141319135|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.69|STANDARD_ERROR_OF_MEAN|8.66||0.5|TWO_SIDED|95.0|-24.14|8.68||Hypothesis tested if TIMP-1 levels after therapy with pentoxifylline changed significantly from baseline from baseline.|Paired t-test.|||Change from baseline in TIMP-1 levels was assessed by paired-t test. Distribution the variable values was assessed using normal probability plots. Matched pairs t-test was used to compare the change from baseline.||8.68|-24.14|0.5
70914096|NCT00954707|141319148|SUPERIORITY_OR_OTHER||Rate of TLF at 12-month (%)|6.4|||||TWO_SIDED|95.0|5.5|7.5||||||||7.5|5.5|
70914097|NCT00954707|141319149|SUPERIORITY_OR_OTHER||Rate of device success (%)|98.0|||||TWO_SIDED|95.0|97.4|98.4||||||||98.4|97.4|
70914098|NCT00954707|141319150|SUPERIORITY_OR_OTHER||Rate of lesion success (%)|99.8|||||TWO_SIDED|95.0|99.6|99.9||||||||99.9|99.6|
70914099|NCT00954707|141319151|SUPERIORITY_OR_OTHER||Rate of procedure success (%)|97.7|||||TWO_SIDED|95.0|97.0|98.2||||||||98.2|97.0|
70914100|NCT00954707|141319152|SUPERIORITY_OR_OTHER||Rate of Clinically-driven TLR (%)|4.2|||||TWO_SIDED|95.0|3.45|5.13||||||||5.13|3.45|
70914101|NCT00954707|141319153|SUPERIORITY_OR_OTHER||Rate of Clinically-driven TVR (%)|5.8|||||TWO_SIDED|95.0|4.87|6.81||||||||6.81|4.87|
70914102|NCT00954707|141319154|SUPERIORITY_OR_OTHER||Rate of Target vessel failure (%)|7.92|||||TWO_SIDED|95.0|6.85|9.09||||||||9.09|6.85|
70914103|NCT00954707|141319155|SUPERIORITY_OR_OTHER||Rate of MACE (%)|7.41|||||TWO_SIDED|95.0|6.37|8.55||||||||8.55|6.37|
70914104|NCT00954707|141319156|SUPERIORITY_OR_OTHER||Rate of protocol defined ST (%)|0.91|||||TWO_SIDED|95.0|0.56|1.38||||||||1.38|0.56|
70914105|NCT00954707|141319157|SUPERIORITY_OR_OTHER||Rate of ARC defined ST (%)|1.12|||||TWO_SIDED|95.0|0.74|1.64||||||||1.64|0.74|
70914106|NCT00954707|141319158|SUPERIORITY_OR_OTHER||Rate of major bleeding complications (%)|3.07|||||TWO_SIDED|95.0|2.4|3.85||||||||3.85|2.40|
70914107|NCT00954707|141319159|SUPERIORITY_OR_OTHER||Rate of cardiac death (%)|0.78|||||TWO_SIDED|95.0|0.46|1.23||||||||1.23|0.46|
70914108|NCT00954707|141319160|SUPERIORITY_OR_OTHER||Rate of non-cardiac death (%)|0.69|||||TWO_SIDED|95.0|0.4|1.12||||||||1.12|0.40|
70914109|NCT00516503|141319161|SUPERIORITY_OR_OTHER|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.90
70914110|NCT00516503|141319162|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.50
70914111|NCT00516503|141319163|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.50
70914112|NCT02987543|141319168|SUPERIORITY||Odds Ratio (OR)|20.86|||<|0.0001|TWO_SIDED|95.0|4.18|379.18|||Regression, Logistic|||||379.18|4.18|<0.0001
70914113|NCT02987543|141319169|SUPERIORITY||Hazard Ratio (HR)|0.49|||<|0.0001|TWO_SIDED|95.0|0.38|0.63|||Regression, Cox|||||0.63|0.38|<0.0001
70914114|NCT02987543|141319170|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.0192|TWO_SIDED|95.0|0.22|0.91|||Regression, Cox|||||0.91|0.22|0.0192
70914115|NCT02987543|141319171|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0175|TWO_SIDED|95.0|0.5|0.97||2-sided p-value|Regression, Cox|||||0.97|0.50|0.0175
70914116|NCT02987543|141319172|SUPERIORITY||Hazard Ratio (HR)|0.34|||<|0.0001|TWO_SIDED|95.0|0.25|0.47|||Regression, Cox|||||0.47|0.25|<0.0001
70914117|NCT00309452|141319173|SUPERIORITY_OR_OTHER|||||||0.018|||||||Chi-squared, Corrected|||Between groups comparison for hospitalization rates, adjusted for pretreatment hospitalization||||0.018
70914118|NCT00309452|141319177|SUPERIORITY_OR_OTHER|||||||0.002|||||||Chi-squared, Corrected|||Between groups comparison for vocational engagement, adjusted for pretreatment vocational engagement||||0.002
70914119|NCT01451814|141319191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.22|TWO_SIDED|95.0|0.67|5.48|||Chi-squared|||||5.48|0.67|.22
70914120|NCT01451814|141319192|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.3||||0.06|TWO_SIDED|95.0|0.84|22.1|||Chi-squared|||||22.1|0.84|.06
70914121|NCT01451814|141319193|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.0||||0.18|TWO_SIDED|95.0|0.56|16.11|||Chi-squared|||||16.11|0.56|.18
70914122|NCT01280591|141319197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-70.3|STANDARD_ERROR_OF_MEAN|13.17||0.0002|TWO_SIDED|95.0|-106.8|-33.7|||ANCOVA|||||-33.7|-106.8|0.0002
70914123|NCT01280591|141319198|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
70914124|NCT01280591|141319199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|70.4|STANDARD_ERROR_OF_MEAN|12.85||0.0001|TWO_SIDED|95.0|28.1|112.7|||ANCOVA|||||112.7|28.1|0.0001
70914125|NCT01280591|141319200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7|STANDARD_ERROR_OF_MEAN|2.14||0.0007|TWO_SIDED|95.0|3.7|19.7|||ANCOVA|||||19.7|3.7|0.0007
70914126|NCT01280591|141319201|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70914127|NCT01280591|141319202|SUPERIORITY_OR_OTHER|||||||0.0027|||||||Cochran-Mantel-Haenszel|||||||0.0027
70914128|NCT01280591|141319203|SUPERIORITY_OR_OTHER|||||||0.0321|||||||Cochran-Mantel-Haenszel|||||||0.0321
70914129|NCT01280591|141319204|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Cochran-Mantel-Haenszel|||||||0.0019
70914130|NCT01280591|141319205|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70914131|NCT01280591|141319206|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Cochran-Mantel-Haenszel|||||||>0.05
70914132|NCT01280591|141319207|SUPERIORITY_OR_OTHER|||||||0.0012|||||||Cochran-Mantel-Haenszel|||||||0.0012
70914133|NCT01280591|141319208|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70914134|NCT01280591|141319209|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70914135|NCT01280591|141319210|SUPERIORITY_OR_OTHER|||||||0.0016|||||||Cochran-Mantel-Haenszel|||||||0.0016
70914136|NCT01280591|141319211|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Cochran-Mantel-Haenszel|||||||>0.05
70914137|NCT01280591|141319212|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70914138|NCT01280591|141319213|SUPERIORITY_OR_OTHER|||||||0.0064|||||||ANCOVA|||||||0.0064
70914139|NCT01280591|141319214|SUPERIORITY_OR_OTHER|||||||0.0047|||||||Cochran-Mantel-Haenszel|||||||0.0047
70914140|NCT01280591|141319215|SUPERIORITY_OR_OTHER|||||||0.0053|||||||Log Rank|||||||0.0053
70914141|NCT01280591|141319217|SUPERIORITY_OR_OTHER|||||||0.2734|||||||Cochran-Mantel-Haenszel|||||||0.2734
70914142|NCT01368406|141319297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.055|TWO_SIDED|95.0|-0.65|1.13|||t-test, 2 sided|t test for independent samples||||1.13|-0.65|0.055
70914143|NCT01368406|141319297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48||||0.055|TWO_SIDED|95.0|0.13|0.83|||t-test, 2 sided|||||0.83|0.13|0.055
71092924|NCT02107898|141692376|SUPERIORITY_OR_OTHER||LS Mean Difference|4.0||||0.0382|TWO_SIDED|95.0|0.2|7.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||7.9|0.2|0.0382
71092925|NCT02107898|141692377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-41.4|||<|0.0001|TWO_SIDED|95.0|-47.0|-35.7||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-35.7|-47.0|<0.0001
70914144|NCT01466881|141319302|SUPERIORITY_OR_OTHER|||||||0.2316|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided alpha level of 0.05||The null hypothesis is that there is no significant difference in Aurora kinase A expression between responders and non-responders.||||0.2316
70914145|NCT01970943|141319311|OTHER||Mean Difference (Final Values)|0.6078||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
70914146|NCT01970943|141319313|OTHER||Mean Difference (Final Values)|0.037786||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||.05
70914147|NCT01710514|141319316|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis (H0) was tested against the alternative (Ha) by constructing two-sided 95%CI for the difference. The non-inferiority limit for the difference was pre-specified to -10.0% (absolute). If the lower limit of the two-sided 95%CI was greater than the non-inferiority limit (-10.0%) for both the FAS and per protocol set, the null hypothesis was to be rejected. In that case it would be claimed that the rate observed in this trial was non-inferior to the rate observed in the CS08 trial|Difference of % to historical control|-0.9|||||TWO_SIDED|95.0|-3.6|1.8||||||To verify sufficient supplementation of luteal hormone, the proportion of subjects with blood progesterone concentration ≥ 10 ng/mL on Day 5 was compared to the result from a historical control, trial CS08 (NCT number: 00884221). The corresponding proportion of subjects in trial CS08 was 99.8% (95%CI: 99.1;100.0, 631/632 subjects). The non-inferiority hypothesis tested for this primary endpoint was: H0: P(000072)-P(CS08) ≤ -10.0% against the alternative Ha: P(000072)-P(CS08) \> -10.0%.||1.8|-3.6|
70914148|NCT02155829|141319324|SUPERIORITY|||||||0.442|||||||ANCOVA|ANCOVA covariate included site.||||||0.442
70914149|NCT02155829|141319325|SUPERIORITY|||||||0.994|||||||ANCOVA|ANCOVA covariate included site.||||||0.994
70914150|NCT02155829|141319326|SUPERIORITY|||||||0.684|||||||ANCOVA|ANCOVA covariate included site.||||||0.684
70914151|NCT02155829|141319327|SUPERIORITY|||||||0.913|||||||ANCOVA|ANCOVA covariate included site.||||||0.913
70914152|NCT02155829|141319328|SUPERIORITY|||||||0.746|||||||ANCOVA|ANCOVA covariate included site.||||||0.746
70914153|NCT02155829|141319329|SUPERIORITY|||||||0.057|||||||ANCOVA|ANCOVA covariate included site.||||||0.057
70914154|NCT02155829|141319330|SUPERIORITY|||||||0.0496|||||||ANCOVA|ANCOVA covariate included site.||||||0.0496
70914155|NCT04897737|141319366|SUPERIORITY||Risk Ratio (RR)|1.83|||<|0.001|TWO_SIDED|95.0|1.19|2.82|||Mixed Models Analysis|||All analyses were by intention-to-treat. In the case of missing outcomes for participants who did not return for the follow-up visit, we assigned outcome values of the following: poor PrEP adherence (TFV undetected) and partner not tested for HIV. We constructed univariate Poisson regression models with robust standard errors to examine the predictors of outcomes of interests. Model results are presented as crude risk ratios (RRs) and risk differences (RDs) with 95% CIs.||2.82|1.19|<0.001
70914156|NCT04897737|141319367|SUPERIORITY||Risk Ratio (RR)|3.89|||<|0.001|TWO_SIDED|95.0|2.08|7.27|||Regression, Linear|||All analyses were by intention-to-treat. In the case of missing outcomes for participants who did not return for the follow-up visit, we assigned outcome values of the following: poor PrEP adherence (TFV undetected) and partner not tested for HIV. We constructed univariate Poisson regression models with robust standard errors to examine the predictors of outcomes of interests. Model results are presented as crude risk ratios (RRs) and 95% CIs.|RD=49.1% (95% CI=32.8, 65.3), p\<0.001|7.27|2.08|<0.001
70914157|NCT00434018|141319369|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||ANOVA|||||||0.001
70914158|NCT01235949|141319384|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.62|||||TWO_SIDED|98.25|-4.52|3.17||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 1.||3.17|-4.52|
70914159|NCT01235949|141319384|NON_INFERIORITY|Criterion for evaluation of non-inferiority: the upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.06|||||TWO_SIDED|98.25|-3.94|4.38||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococcal serotype 4.||4.38|-3.94|
70914160|NCT01235949|141319384|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.64|||||TWO_SIDED|98.25|-4.63|3.19||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 5.||3.19|-4.63|
70914161|NCT01235949|141319384|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.69|||||TWO_SIDED|98.25|-9.4|10.99||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 6B.||10.99|-9.4|
70914162|NCT01235949|141319384|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.65|||||TWO_SIDED|98.25|-2.7|4.71||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 7F.||4.71|-2.7|
70914163|NCT01235949|141319384|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.58|||||TWO_SIDED|98.25|-5.05|3.82||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 9V.||3.82|-5.05|
70914164|NCT01235949|141319384|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.65|||||TWO_SIDED|98.25|-4.68|3.15||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 14.||3.15|-4.68|
70914165|NCT01235949|141319384|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.58|||||TWO_SIDED|98.25|-5.04|3.85||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 18C.||3.85|-5.04|
70914166|NCT01235949|141319384|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.63|||||TWO_SIDED|98.25|-4.6|3.14||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 19F.||3.14|-4.6|
70914167|NCT01235949|141319384|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.08||||||98.25|-7.66|8.1||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 23F.||8.1|-7.66|
70914168|NCT01235949|141319384|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.62|||||TWO_SIDED|98.25|-4.52|2.91||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 1.||2.91|-4.52|
70914169|NCT01235949|141319384|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.63|||||TWO_SIDED|98.25|-4.57|2.91||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 4.||2.91|-4.57|
70914170|NCT01235949|141319384|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.64|||||TWO_SIDED|98.25|-4.63|2.92||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 5.||2.92|-4.63|
70914171|NCT01235949|141319384|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-2.38|||||TWO_SIDED|98.25|-12.02|7.22||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 6B.||7.22|-12.02|
70970687|NCT00531752|141447062|SUPERIORITY_OR_OTHER||LS Mean Difference|3.7518|STANDARD_ERROR_OF_MEAN|3.0743||0.2284|TWO_SIDED|80.0|-0.2442|7.7479|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||7.7479|-0.2442|0.2284
70914172|NCT01235949|141319384|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.0|||||TWO_SIDED|98.25|-3.34|3.48||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 7F.||3.48|-3.34|
70914173|NCT01235949|141319384|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-1.27|||||TWO_SIDED|98.25|-5.66|2.32||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 9V.||2.32|-5.66|
70914174|NCT01235949|141319384|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.0|||||TWO_SIDED|98.25|-4.08|4.12||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 14.||4.12|-4.08|
70914175|NCT01235949|141319384|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.62|||||TWO_SIDED|98.25|-5.08|3.54||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 18C.||3.54|-5.08|
70914176|NCT01235949|141319384|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.67|||||TWO_SIDED|98.25|-3.4|5.2||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 19F.||5.2|-3.4|
70914177|NCT01235949|141319384|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|2.73|||||TWO_SIDED|98.25|-5.3|11.04||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 23F.||11.04|-5.3|
70914178|NCT01235949|141319385|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.96|||||TWO_SIDED|99.8|0.71|1.29||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 1.||1.29|0.71|
70914179|NCT01235949|141319385|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.02|||||TWO_SIDED|99.8|0.77|1.35||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 4.||1.35|0.77|
70914180|NCT01235949|141319385|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.06|||||TWO_SIDED|99.8|0.8|1.41||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 5.||1.41|0.8|
70914181|NCT01235949|141319385|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.12|||||TWO_SIDED|99.8|0.72|1.74||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 6B.||1.74|0.72|
70914182|NCT01235949|141319385|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.04|||||TWO_SIDED|99.8|0.79|1.35||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 7F.||1.35|0.79|
71092926|NCT02107898|141692378|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-15.5||||0.0007|TWO_SIDED|95.0|-24.4|-6.6||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-6.6|-24.4|0.0007
71092927|NCT02107898|141692379|SUPERIORITY_OR_OTHER||LS Mean Difference|6.5|||<|0.0001|TWO_SIDED|95.0|3.7|9.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||9.3|3.7|<0.0001
71153850|NCT00488683|141800057|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||
70914183|NCT01235949|141319385|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.96|||||TWO_SIDED|99.8|0.7|1.31||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 9V.||1.31|0.7|
70914184|NCT01235949|141319385|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.0|||||TWO_SIDED|99.8|0.71|1.4||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 14.||1.4|0.71|
70914185|NCT01235949|141319385|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.89|||||TWO_SIDED|99.8|0.6|1.31||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 18C.||1.31|0.6|
70914186|NCT01235949|141319385|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.23|||||TWO_SIDED|99.8|0.87|1.75||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 19F.||1.75|0.87|
70914187|NCT01235949|141319385|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.97|||||TWO_SIDED|99.8|0.66|1.44||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 23F.||1.44|0.66|
70914188|NCT01235949|141319385|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.9|||||TWO_SIDED|99.8|0.67|1.21||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 1.||1.21|0.67|
70914189|NCT01235949|141319385|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.0|||||TWO_SIDED|99.8|0.76|1.32||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 4.||1.32|0.76|
70914190|NCT01235949|141319385|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.86|||||TWO_SIDED|99.8|0.66|1.14||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 5.||1.14|0.66|
70914191|NCT01235949|141319385|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.28|||||TWO_SIDED|99.8|0.83|1.97||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 6B.||1.97|0.83|
70914192|NCT01235949|141319385|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.02|||||TWO_SIDED|99.8|0.8|1.31||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 7F.||1.31|0.8|
70914193|NCT01235949|141319385|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.92|||||TWO_SIDED|99.8|0.69|1.22||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 9V.||1.22|0.69|
70914194|NCT01235949|141319385|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.95|||||TWO_SIDED|99.8|0.68|1.32||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 14.||1.32|0.68|
70914195|NCT01235949|141319385|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.88|||||TWO_SIDED|99.8|0.6|1.27||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 18C.||1.27|0.6|
70970688|NCT00531752|141447062|SUPERIORITY_OR_OTHER||LS Mean Difference|8.5752|STANDARD_ERROR_OF_MEAN|3.5848||0.0201|TWO_SIDED|80.0|3.9265|13.224|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||13.224|3.9265|0.0201
71153851|NCT00488683|141800058|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.14||||0.68||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup A||||0.68
70970689|NCT00531752|141447062|SUPERIORITY_OR_OTHER||LS Mean Difference|5.0229|STANDARD_ERROR_OF_MEAN|3.8154||0.1931|TWO_SIDED|80.0|0.07753|9.9683|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||9.9683|0.07753|0.1931
71153852|NCT00488683|141800058|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.44||||0.09||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup C||||0.09
71153853|NCT00488683|141800058|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.11||||0.69||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup W-135||||0.69
71153854|NCT00488683|141800058|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.38||||0.2||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup Y||||0.20
71153855|NCT00488683|141800058|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.05||||0.88||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup A||||0.88
71153856|NCT00488683|141800058|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.41||||0.12||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup C||||0.12
71153857|NCT00488683|141800058|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.25||||0.37||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup W-135||||0.37
71153858|NCT00488683|141800058|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.28||||0.36||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup Y||||0.36
71153859|NCT00488683|141800058|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup A||||
71153860|NCT00488683|141800058|SUPERIORITY_OR_OTHER||R-square|0.2||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup C||||
71153861|NCT00488683|141800058|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup W-135||||
71153862|NCT00488683|141800058|SUPERIORITY_OR_OTHER||R-square|0.15||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup Y||||
71153863|NCT00488683|141800058|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|1.0||||||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup C||||
71153864|NCT00488683|141800058|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|1.0||||||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup C||||
71153865|NCT00488683|141800058|SUPERIORITY_OR_OTHER||R-square|1.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup C||||
71153866|NCT00488683|141800058|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup W-135||||
71153867|NCT00488683|141800058|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup Y||||
71153868|NCT00488683|141800058|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.08||||0.79||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup A||||0.79
71153869|NCT00488683|141800058|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.35||||0.16||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup C||||0.16
71153870|NCT00488683|141800058|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.48||||0.1||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup W-135||||0.10
71153871|NCT00488683|141800058|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.98||||0.003||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup Y||||0.003
71153872|NCT00488683|141800058|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.03||||0.91||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup A||||0.91
71153873|NCT00488683|141800058|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.57||||0.01||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup C||||0.01
71153874|NCT00488683|141800058|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.39||||0.19||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup W-135||||0.19
70914196|NCT01235949|141319385|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.02|||||TWO_SIDED|99.8|0.72|1.44||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 19F.||1.44|0.72|
70914197|NCT01235949|141319385|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.86|||||TWO_SIDED|99.8|0.58|1.27||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 23F.||1.27|0.58|
70914198|NCT01235949|141319386|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for protein D.|GMC ratio|0.94|||||TWO_SIDED|99.8|0.69|1.28||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-Protein D (anti-PD) antibody.||1.28|0.69|
70914199|NCT01235949|141319386|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for protein D.|GMC ratio|0.87|||||TWO_SIDED|99.8|0.64|1.17||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-Protein D (anti-PD) antibody.||1.17|0.64|
70914200|NCT04173572|141319409|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-13.47|STANDARD_DEVIATION|48.09|||TWO_SIDED|||||||||Posttreatment - Baseline: 10 participants analyzed (had data at both time points)||||
70914201|NCT04173572|141319409|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|1.7|STANDARD_DEVIATION|52.743|||TWO_SIDED|||||||||Posttreatment - Baseline: 9 participants analyzed (had data at both time points)||||
70914202|NCT04173572|141319410|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|22.133|STANDARD_DEVIATION|79.938|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
70914203|NCT04173572|141319410|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|7.8|STANDARD_DEVIATION|99.645|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
70914204|NCT04173572|141319411|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|13.642|STANDARD_DEVIATION|4213.837|||TWO_SIDED|||||||||Posttreatment - Baseline: 14 participants analyzed (had data at both time points)||||
70914205|NCT04173572|141319411|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-483.4|STANDARD_DEVIATION|2497.312|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
70914206|NCT04173572|141319412|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-0.8|STANDARD_DEVIATION|4.229|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
70914207|NCT04173572|141319412|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|1.563|STANDARD_DEVIATION|8.695|||TWO_SIDED|||||||||Posttreatment - Baseline: 16 participants analyzed (had data at both time points)||||
70914208|NCT04173572|141319413|OTHER|Single group mean difference between baseline and post-treatment assessments.|Median Difference (Net)|-9.333|STANDARD_DEVIATION|14.166|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
70914209|NCT04173572|141319413|OTHER|Single group mean difference between baseline and post-treatment assessments.|Median Difference (Net)|0.625|STANDARD_DEVIATION|9.664|||TWO_SIDED|||||||||Posttreatment - Baseline: 16 participants analyzed (had data at both time points)||||
70914210|NCT04173572|141319414|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-0.392|STANDARD_DEVIATION|1.148|||TWO_SIDED|||||||||Posttreatment - Baseline: 13 participants analyzed (had data at both time points)||||
71153875|NCT00488683|141800058|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.89||||0.04||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup Y||||0.04
70914211|NCT04173572|141319414|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|0.113|STANDARD_DEVIATION|1.401|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
70914212|NCT04173572|141319415|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|2.2|STANDARD_DEVIATION|20.11|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
70914213|NCT04173572|141319415|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|0.49|STANDARD_DEVIATION|8.91|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
70914214|NCT04173572|141319416|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-0.39|STANDARD_DEVIATION|4.67|||TWO_SIDED|||||||||Posttreatment - Baseline: 11 participants analyzed (had data at both time points)||||
70914215|NCT04173572|141319416|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|3.43|STANDARD_DEVIATION|9.4|||TWO_SIDED|||||||||Posttreatment - Baseline: 11 participants analyzed (had data at both time points)||||
70914216|NCT04173572|141319417|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-3.667|STANDARD_DEVIATION|9.067|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
70914217|NCT04173572|141319417|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-2.071|STANDARD_DEVIATION|12.25|||TWO_SIDED|||||||||Posttreatment - Baseline: 14 participants analyzed (had data at both time points)||||
70914218|NCT04173572|141319418|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-0.8|STANDARD_DEVIATION|9.9|||TWO_SIDED|||||||||Posttreatment - Baseline: 14 participants analyzed (had data at both time points)||||
70914219|NCT04173572|141319418|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|0.714|STANDARD_DEVIATION|11.717|||TWO_SIDED|||||||||Posttreatment - Baseline: 14 participants analyzed (had data at both time points)||||
70914220|NCT04173572|141319419|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|3.071|STANDARD_DEVIATION|10.737|||TWO_SIDED|||||||||Posttreatment - Baseline: 14 participants analyzed (had data at both time points)||||
70914221|NCT04173572|141319419|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|5.571|STANDARD_DEVIATION|9.288|||TWO_SIDED|||||||||Posttreatment - Baseline: 14 participants analyzed (had data at both time points)||||
70914222|NCT01199237|141319495|SUPERIORITY_OR_OTHER|||||||0.11||||||Significant at p\<0.05|Chi-squared|||||||0.11
70914223|NCT00556543|141319501|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation performed.||||||0.19||95.0|||||Fisher Exact|||Fisher's Exact Test with the null hypothesis that the proportion with adverse events was the same in both groups.||||0.190
70914224|NCT01838551|141319512|SUPERIORITY|Under the null hypothesis of at most 20% UFC responders, 90 subjects in the ITT population would provide 90% power, with two-sided type 1 error of 0.05, assuming an observed response of 35%.||||||0.0154||||||One-sided p-value is based on a null hypothesis that true response proportion is ≤ 0.20.|Mixed Models Analysis|The Generalized Linear Model described above was used to generate the p-value.||The least squares mean (LSMEAN) estimate of the UFC response after 6 months of treatment in the Maintenance Phase alongside its 95% Wald CI is presented. Supportive to the 95% CI, the p-value corresponding to the null hypothesis that the response rate is ≤ 20% is presented (1-sided test).||||0.0154
70914225|NCT01875250|141319549|SUPERIORITY|||||||0.74|||||||Wilcoxon rank sum tests|||||||0.74
70914226|NCT03068468|141319561|SUPERIORITY||Difference|-0.2||||0.8483|TWO_SIDED|95.0|-2.0|1.6|||Mixed model for repeated measures (MMRM)|||28-item:Adjusted mean for each treatment group, difference with Placebo,95% confidence interval and p-value at each time point were based on a mixed model for repeated measures model (MMRM), with change from baseline in 28-item PSPRS total score as dependent variable and with fixed effects of treatment group, time(categorical), treatment group-by-time interaction, baseline 28-item PSPRS, baseline 28-item PSPRS by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||1.6|-2.0|0.8483
70914227|NCT03068468|141319561|SUPERIORITY||Difference|-0.28||||0.6503|TWO_SIDED|95.0|-1.5|0.94|||MMRM|||15-items:Adjusted mean for each treatment group, difference with Placebo,95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in 15-item PSPRS total score as dependent variable and with fixed effects of treatment group, time(categorical), treatment groupby-time interaction, baseline 15-item PSPRS, baseline 15-item PSPRS by time interaction, baseline Color Trails 2 test(\<=170 or \>170 seconds) and region.||0.94|-1.50|0.6503
70914228|NCT03068468|141319563|SUPERIORITY||Difference|0.4||||0.6031|TWO_SIDED|95.0|-1.0|1.7|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MDS-UPDRS as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline MDS-UPDRS, baseline MDS-UPDRS by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||1.7|-1.0|0.6031
70914229|NCT03068468|141319564|SUPERIORITY||Difference|0.0||||0.7743|TWO_SIDED|95.0|-0.2|0.1|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with CGI-C as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline CGI-S, baseline CGI-S by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.1|-0.2|0.7743
70914230|NCT03068468|141319565|SUPERIORITY||Difference|0.038||||0.318|TWO_SIDED|95.0|-0.036|0.112|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in PSP-cognitive composite battery as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline PSP-cognitive composite battery, baseline PSP-cognitive composite battery by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.112|-0.036|0.3180
70914231|NCT03068468|141319566|SUPERIORITY||Difference|-0.2||||0.827|TWO_SIDED|95.0|-1.8|1.4|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in RBANS as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline RBANS , baseline RBANS by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds and region.||1.4|-1.8|0.8270
70914232|NCT03068468|141319567|SUPERIORITY||Difference|-0.2||||0.9304|TWO_SIDED|95.0|-3.6|3.3|||MMRM|||Physical scale score: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in PSP-QoL as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for PSP-QoL, baseline PSP-QoL by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||3.3|-3.6|0.9304
70914233|NCT03068468|141319567|SUPERIORITY||Difference|0.5||||0.7859|TWO_SIDED|95.0|-2.8|3.7|||MMRM|||Mental scale score: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in PSPQoL as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-bytime interaction, baseline for PSP-QoL, baseline PSP-QoL by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||3.7|-2.8|0.7859
70914234|NCT03068468|141319567|SUPERIORITY||Difference|-1.7||||0.4297|TWO_SIDED|95.0|-5.8|2.5|||MMRM|||Satisfaction With Your Life Today: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in PSPQoL as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-bytime interaction, baseline for PSP-QoL, baseline PSP-QoL by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||2.5|-5.8|0.4297
71153876|NCT00488683|141800058|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup A||||
70914235|NCT03068468|141319568|SUPERIORITY||Difference|2.0||||0.2084|TWO_SIDED|95.0|-1.1|5.2|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in SEADL as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for SEADL , baseline SEADL by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||5.2|-1.1|0.2084
70914236|NCT03068468|141319569|SUPERIORITY||Difference|0.0||||0.5701|TWO_SIDED|95.0|-0.2|0.1|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in CGI-S as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for CGI-S, baseline CGI-S by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.1|-0.2|0.5701
70914237|NCT03068468|141319570|SUPERIORITY||Difference|0.9||||0.0517|TWO_SIDED|95.0|0.0|1.8|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in Phonemic Fluency Test as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline Phonemic Fluency Test, baseline Phonemic Fluency Test by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||1.8|-0.0|0.0517
70914238|NCT03068468|141319571|SUPERIORITY||Difference|0.9||||0.0387|TWO_SIDED|95.0|0.0|1.7|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in Letter Number Sequence as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline Letter Number Sequence, baseline Letter Number Sequence by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||1.7|0.0|0.0387
70914239|NCT03068468|141319572|SUPERIORITY||Difference|0.1||||0.9815|TWO_SIDED|95.0|-8.1|8.3|||MMRM|||Color Trails Test 1: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in Color trails Test 1 as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for Color Trails Test 1, baseline Color Trails Test 1 by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||8.3|-8.1|0.9815
70914240|NCT03068468|141319572|SUPERIORITY||Difference|0.0||||0.9869|TWO_SIDED|95.0|-5.7|5.6|||MMRM|||Color Trails Test 2: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in Color Trails Test 2 as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for Color Trails Test 2, baseline Color Trails Test 2 by time interaction, and region.||5.6|-5.7|0.9869
70914241|NCT03068468|141319573|SUPERIORITY||Difference|0.5||||0.1763|TWO_SIDED|95.0|-0.2|1.2|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MoCA as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MoCA, baseline MoCA by time interaction,baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||1.2|-0.2|0.1763
70914242|NCT03068468|141319575|SUPERIORITY||Difference|-0.021||||0.9527|TWO_SIDED|95.0|-0.726|0.684|||MMRM|||Ventricles Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.684|-0.726|0.9527
70914243|NCT03068468|141319575|SUPERIORITY||Difference|-0.514||||0.7357|TWO_SIDED|95.0|-3.506|2.478|||MMRM|||Whole Brain Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||2.478|-3.506|0.7357
70914244|NCT03068468|141319575|SUPERIORITY||Difference|-0.004||||0.6439|TWO_SIDED|95.0|-0.023|0.014|||MMRM|||Midbrain Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.014|-0.023|0.6439
70914245|NCT03068468|141319575|SUPERIORITY||Difference|0.0||||0.9864|TWO_SIDED|95.0|-0.039|0.04|||MMRM|||Pons Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.040|-0.039|0.9864
70914246|NCT03068468|141319575|SUPERIORITY||Difference|0.001||||0.7529|TWO_SIDED|95.0|-0.004|0.006|||MMRM|||Cerebellar Peduncle Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.006|-0.004|0.7529
71153877|NCT00488683|141800058|SUPERIORITY_OR_OTHER||R-square|0.12||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup C||||
71153878|NCT00488683|141800058|SUPERIORITY_OR_OTHER||R-square|0.23||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup W-135||||
70914247|NCT03068468|141319575|SUPERIORITY||Difference|0.006||||0.685|TWO_SIDED|95.0|-0.025|0.038|||MMRM|||Third Ventricle Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.038|-0.025|0.6850
70914248|NCT03068468|141319575|SUPERIORITY||Difference|-0.041||||0.9|TWO_SIDED|95.0|-0.68|0.598|||MMRM|||Frontal Lobe Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.598|-0.680|0.9000
70914249|NCT03720990|141319632|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|||||||0.011
70914250|NCT02657629|141319636|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
70914251|NCT02281318|141319672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.7|||<|0.001|TWO_SIDED|95.0|-10.5|-4.9|||Mixed model repeated measures analysis|||||-4.9|-10.5|<0.001
70914252|NCT02281318|141319673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|120.0||||0.001|TWO_SIDED|95.0|47.0|192.0|||Mixed model repeated measures analysis|||||192|47|0.001
70914253|NCT02281318|141319674|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.23|||<|0.001|TWO_SIDED|95.0|1.55|3.22|||Regression, Logistic|||||3.22|1.55|<0.001
70914254|NCT02281318|141319675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.58|-0.22|||Mixed model repeated measures analysis|||||-0.22|-0.58|<0.001
70914255|NCT00812877|141319676|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.35||||0.046|TWO_SIDED|95.0|1.19|4.66||A clustered permutation test with 10,000 random permutations based on the log rank test statistic was used for the primary treatment comparison to account for censoring and to ensure proper test size given the number of practices.|Log Rank||A confirmatory analysis, adjusted for patient, dentist, and tooth characteristics, and follow-up time, was performed using marginal proportional hazards regression with robust standard error estimates accounting for clustering by practice.|||4.66|1.19|.046
70914256|NCT02228408|141319686|SUPERIORITY|||||||0.04|||||||poisson|||||||0.04
70914257|NCT02228408|141319687|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||||||0.19
70914258|NCT02228408|141319688|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|||||||0.34
70914259|NCT02228408|141319692|SUPERIORITY|||||||0.62|||||||t-test, 2 sided|||||||0.62
70914260|NCT03670602|141319715|SUPERIORITY|||||||0.0035||||||This is for the treatment group x time effect, or if treatment influenced improvements in delay discounting across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Treatment group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate.||||0.0035
70914261|NCT03670602|141319715|SUPERIORITY||||||<|0.001||||||This is for the time effect, or if delay discounting improved across all three timepoints, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Treatment group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||<0.001
70914262|NCT03670602|141319716|SUPERIORITY|||||||0.85||||||This is for the treatment group x time effect, or if treatment differentially influenced weight across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.85
70914263|NCT03670602|141319716|SUPERIORITY||||||<|0.001||||||This is for the time effect, or if time influenced changes in weight, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||<0.001
70914264|NCT03670602|141319717|SUPERIORITY|||||||0.79||||||This is for the treatment group x time effect, or if treatment group influenced change in hBa1c across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.79
70914265|NCT03670602|141319717|SUPERIORITY||||||<|0.001||||||This is for the time effect, or if hBa1c changed across timepoints, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||<0.001
70914266|NCT03670602|141319718|SUPERIORITY|||||||0.201||||||This is for the treatment group x time effect, or if treatment differentially influenced medication adherence across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.201
70970690|NCT00531752|141447063|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6766|STANDARD_ERROR_OF_MEAN|0.1759||0.0003|TWO_SIDED|80.0|-0.9046|-0.4487|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.4487|-0.9046|0.0003
70970691|NCT00531752|141447063|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3075|STANDARD_ERROR_OF_MEAN|0.1871||0.1055|TWO_SIDED|80.0|-0.5499|-0.065|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.0650|-0.5499|0.1055
71153879|NCT00488683|141800058|SUPERIORITY_OR_OTHER||R-square|0.96||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup Y||||
71153880|NCT00488683|141800058|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.18||||0.46||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup A||||0.46
71153881|NCT00488683|141800058|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.03||||0.9||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup C||||0.90
71153882|NCT00488683|141800058|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.51||||0.008||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup W-135||||0.008
71153883|NCT00488683|141800058|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.42||||0.08||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup Y||||0.08
71153884|NCT00488683|141800058|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.15||||0.52||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup A||||0.52
71153885|NCT00488683|141800058|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.27||||0.18||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup C||||0.18
71153886|NCT00488683|141800058|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.37||||0.07||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup W-135||||0.07
71153887|NCT00488683|141800058|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.14||||0.55||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup Y||||0.55
71153888|NCT00488683|141800058|SUPERIORITY_OR_OTHER||R-square|0.03||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup A||||
71153889|NCT00488683|141800058|SUPERIORITY_OR_OTHER||R-square|0.0007||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup C||||
71153890|NCT00488683|141800058|SUPERIORITY_OR_OTHER||R-square|0.27||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup W-135||||
71153891|NCT00488683|141800058|SUPERIORITY_OR_OTHER||R-square|0.17||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup Y||||
71153892|NCT00488683|141800059|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.45||||0.0006||95.0|||||Parametric correlation||Values from Group 1, 2 and 3 were combined for this analysis.|Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells at 12 months of age||||0.0006
71153893|NCT00488683|141800059|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.41||||0.0021||95.0|||||Non-parametric correlation||Values from Group 1, 2 and 3 were combined for this analysis.|Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells at 12 months of age||||0.0021
71153894|NCT00488683|141800059|SUPERIORITY_OR_OTHER||R-square|0.21||||||95.0|||||Regression, Linear||Values from Group 1, 2 and 3 were combined for this analysis.|Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells at 12 months of age||||
70914267|NCT03670602|141319718|SUPERIORITY|||||||0.315||||||This is for the time effect, or if timepoint influenced medication adherence across all timepoints, independent of treatment group. The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.315
70914268|NCT03670602|141319719|SUPERIORITY|A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||||0.345||||||This is for the treatment group x time effect, or if treatment group influenced change in percent of time engaged in moderate-to-vigorous physical activity (MVPA) across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||||||0.345
71153895|NCT00488683|141800059|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.15||||0.53||95.0|||||Parametric correlation|||Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells 1 month after booster vaccination||||0.53
71153896|NCT00488683|141800059|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.21||||0.26||95.0|||||Parametric correlation||Values from Groups 1, 2 and 3 were combined for this analysis.|Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination||||0.26
71153897|NCT00488683|141800059|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.05||||0.84||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination||||0.84
70914269|NCT03670602|141319719|SUPERIORITY|||||||0.0003||||||This is for the time effect, or if percent of time engaged in moderate-to-vigorous physical activity (MVPA) changed across timepoints, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.0003
70914270|NCT03670602|141319720|SUPERIORITY|||||||0.007||||||This is for the treatment group x time effect, or if treatment differentially influenced changes in calorie intake across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.007
70914271|NCT03670602|141319720|SUPERIORITY||||||<|0.0001||||||This is for the time effect, or if time influenced changes in calorie intake, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||<0.0001
70914272|NCT03670602|141319721|SUPERIORITY|||||||0.774||||||This is for the treatment group x time effect, or if treatment differentially influenced changes in working memory across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.774
70914273|NCT03670602|141319721|SUPERIORITY|||||||0.019||||||This is for the time effect, or if time influenced changes in working memory, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.019
70914274|NCT03670602|141319722|SUPERIORITY|||||||0.65||||||This is for the treatment group x time effect, or if treatment differentially influenced relative reinforcing efficacy of unhealthy food across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.650
70914275|NCT03670602|141319722|SUPERIORITY||||||<|0.0001||||||This is for the time effect, or if time influenced changes in relative reinforcing efficacy of unhealthy food, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||<0.0001
70914276|NCT01456936|141319723|SUPERIORITY_OR_OTHER|||||||0.0652||||||An interaction between treatment and cohort was considered significant at 10% level. No multiplicity adjustments were utilized.|Regression, Linear|A generalized linear regression analysis based on the safety analysis set was used to evaluate incidence of NPS AE as the primary analysis.||The reduced (final) statistical model included treatment group, cohort and region, plus the 2-way interaction of treatment by cohort. Other interactions not included due to lack of significance. Region reduced to 2-level to address event sparseness issue.||||0.0652
70914277|NCT01456936|141319724|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.28|||||TWO_SIDED|95.0|-2.4|-0.15|||Regression, Linear||Risk difference for varenicline versus placebo from estimation model.|Non-psychiatric cohort||-0.15|-2.40|
70914278|NCT01456936|141319724|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.08|||||TWO_SIDED|95.0|-1.37|1.21|||Regression, Linear||Risk difference for bupropion 150 mg BID versus placebo from estimation model.|Non-psychiatric cohort||1.21|-1.37|
70914279|NCT01456936|141319724|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.21|||||TWO_SIDED|95.0|-1.54|1.12|||Regression, Linear||Risk difference for NRT versus placebo from estimation model.|Non-psychiatric cohort||1.12|-1.54|
70914280|NCT01456936|141319724|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.59|||||TWO_SIDED|95.0|-0.42|3.59|||Regression, Linear||Risk difference for varenicline versus placebo from estimation model|Psychiatric cohort||3.59|-0.42|
70914281|NCT01456936|141319724|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.78|||||TWO_SIDED|95.0|-0.24|3.81|||Regression, Linear||Risk difference for bupropion 150 mg BID versus placebo from estimation model.|Psychiatric cohort||3.81|-0.24|
70914282|NCT01456936|141319724|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.37|||||TWO_SIDED|95.0|-1.53|2.26|||Regression, Linear||Risk difference for NRT versus placebo from estimation model.|Psychiatric cohort||2.26|-1.53|
70914283|NCT01456936|141319739|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0|||<|0.0001|TWO_SIDED|95.0|3.2|5.0||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||5.00|3.20|<0.0001
70914284|NCT01456936|141319739|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.26|||<|0.0001|TWO_SIDED|95.0|1.8|2.85||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.85|1.80|<0.0001
70914285|NCT01456936|141319739|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.0001|TWO_SIDED|95.0|1.83|2.9||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.90|1.83|<0.0001
70914286|NCT01456936|141319740|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.24|||<|0.0001|TWO_SIDED|95.0|2.56|4.11||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||4.11|2.56|<0.0001
70914287|NCT01456936|141319740|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87|||<|0.0001|TWO_SIDED|95.0|1.46|2.39||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.39|1.46|<0.0001
70914288|NCT01456936|141319740|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0|||<|0.0001|TWO_SIDED|95.0|1.56|2.55||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.55|1.56|<0.0001
70914289|NCT01456936|141319741|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.61|||<|0.0001|TWO_SIDED|95.0|3.07|4.24||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.||4.24|3.07|<0.0001
70914290|NCT01456936|141319741|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.07|||<|0.0001|TWO_SIDED|95.0|1.75|2.45||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.||2.45|1.75|<0.0001
70914291|NCT01456936|141319741|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.15|||<|0.0001|TWO_SIDED|95.0|1.82|2.54||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.||2.54|1.82|<0.0001
70914292|NCT01456936|141319742|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.99|||<|0.0001|TWO_SIDED|95.0|2.33|3.83||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||3.83|2.33|<0.0001
70914293|NCT01456936|141319742|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0|||<|0.0001|TWO_SIDED|95.0|1.54|2.59||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.59|1.54|<0.0001
70914294|NCT01456936|141319742|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96|||<|0.0001|TWO_SIDED|95.0|1.51|2.54||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.54|1.51|<0.0001
70914295|NCT01456936|141319743|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5|||<|0.0001|TWO_SIDED|95.0|1.9|3.29||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||3.29|1.90|<0.0001
70914296|NCT01456936|141319743|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77|||<|0.0001|TWO_SIDED|95.0|1.33|2.36||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.36|1.33|<0.0001
70914297|NCT01456936|141319743|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65|||<|0.0001|TWO_SIDED|95.0|1.24|2.2||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.20|1.24|<0.0001
70914298|NCT01456936|141319744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.74|||<|0.0001|TWO_SIDED|95.0|2.28|3.3||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.||3.30|2.28|<0.0001
70914299|NCT01456936|141319744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.89|||<|0.0001|TWO_SIDED|95.0|1.56|2.29||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.||2.29|1.56|<0.0001
70914300|NCT01456936|141319744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81|||<|0.0001|TWO_SIDED|95.0|1.49|2.19||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.||2.19|1.49|<0.0001
70914301|NCT00543725|141319748|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|3.7|||<|0.0001||95.0|-1.6|9.0||Significance level was set at 2.5% (one-sided). No adjustment of p-value for multiple comparisons, since there was only single comparison for the primary endpoint.|Regression, Logistic|Logistic regression model included treatment arm and background NRTI regimen as factors, and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|Assuming a response rate of 75% at 48 weeks for both treatment groups, 340 subjects were needed per treatment (TMC278 or EFV) to establish non-inferiority of TMC278 versus EFV with a maximum allowable difference of 12% and a 1-sided significance level of 2.5%, to yield 95% power.||9.0|-1.6|<0.0001
70914302|NCT00543725|141319749|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|3.9|||<|0.0001||95.0|-1.9|9.6|||Regression, Logistic|Logistic regression model included treatment arm and background NRTI regimen as factors, and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|||9.6|-1.9|<0.0001
71153898|NCT00488683|141800059|SUPERIORITY_OR_OTHER||Spearman Correlation Coefficient|0.22||||0.26||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination||||0.26
71153899|NCT00488683|141800059|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear|||Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination||||
70914303|NCT00543725|141319750|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|2.4|||<|0.0001||95.0|-3.6|8.4||Significance level was set at 2.5% (one-sided). No adjustment of p-value for multiple comparisons, since there was only single comparison for the primary endpoint.|Regression, Logistic|Logistic regression model included treatment arm and background NRTI regimen as factors, and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|Assuming a response rate of 75% at 48 weeks for both treatment groups, 340 subjects were needed per treatment (TMC278 or EFV) to establish non-inferiority of TMC278 versus EFV with a maximum allowable difference of 12% and a 1-sided significance level of 2.5%, to yield 95% power.||8.4|-3.6|<0.0001
70914304|NCT00543725|141319751|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|0.7|||<|0.0001||95.0|-5.6|7.0|||Regression, Logistic|Logistic regression model included treatment arm and background NRTI regimen as factors, and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|||7.0|-5.6|<0.0001
70914305|NCT00906698|141319766|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|126.2|||||TWO_SIDED|90.0|69.549|229.012|||ANOVA|||||229.012|69.549|
70914306|NCT00906698|141319767|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|75.58|||||TWO_SIDED|90.0|65.037|87.837|||ANOVA|||||87.837|65.037|
71153900|NCT00488683|141800059|SUPERIORITY_OR_OTHER||R-square|0.05||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination||||
70914307|NCT00906698|141319768|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|132.8|||||TWO_SIDED|90.0|72.305|243.917|||ANOVA|||||243.917|72.305|
70914308|NCT00906698|141319769|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|83.8|||||TWO_SIDED|90.0|61.156|114.823|||ANOVA|||||114.823|61.156|
70914309|NCT00906698|141319772|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|90.21|||||TWO_SIDED|90.0|76.071|106.978|||ANOVA|||||106.978|76.071|
70914310|NCT00906698|141319773|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|76.75|||||TWO_SIDED|90.0|56.71|103.871|||ANOVA|||||103.871|56.710|
70914311|NCT00906698|141319774|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|83.86|||||TWO_SIDED|95.0|66.369|105.966|||ANOVA|||||105.966|66.369|
70914312|NCT00906698|141319775|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|81.7|||||TWO_SIDED|90.0|60.47|110.369|||ANOVA|||||110.369|60.470|
70914313|NCT03383887|141319785|SUPERIORITY||Median Difference (Final Values)|2.7||||0.56|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.56
70914314|NCT03383887|141319786|SUPERIORITY|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||||||0.027
70914315|NCT01585038|141319792|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.54||||0.3|TWO_SIDED|95.0|-1.56|2.64|||t-test, 1 sided|||||2.64|-1.56|0.30
70914316|NCT01585038|141319793|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.21||||0.35|TWO_SIDED|95.0|-4.71|2.3|||t-test, 2 sided|||||2.30|-4.71|0.35
70914317|NCT01585038|141319794|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.7||||0.41|TWO_SIDED|95.0|-62.49|75.89|||t-test, 2 sided|||||75.89|-62.49|0.41
70914318|NCT01585038|141319795|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-194.1||||0.02|TWO_SIDED|95.0|-353.7|-34.6|||t-test, 2 sided|||||-34.6|-353.7|0.02
70914319|NCT01335932|141319797|OTHER|||||||0.0001|||||||Fisher Exact|||||||.0001
70914320|NCT01335932|141319798|OTHER|||||||0.31|||||||t-test, 2 sided|||||||0.31
70914321|NCT01335932|141319804|OTHER|||||||0.006|||||||Fisher Exact|||||||0.006
70914322|NCT01335932|141319805|OTHER|||||||0.14|||||||Fisher Exact|||||||0.14
70914323|NCT01335932|141319806|OTHER|||||||0.1|||||||Fisher Exact|||||||0.10
70914324|NCT01335932|141319807|OTHER|||||||0.002|||||||t-test, 2 sided|||||||0.002
70914325|NCT01335932|141319808|OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.03
70914326|NCT01335932|141319809|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70914327|NCT01335932|141319810|OTHER|||||||0.73|||||||t-test, 2 sided|||||||0.73
70914328|NCT01335932|141319811|OTHER|||||||0.33|||||||t-test, 2 sided|||||||0.33
70914329|NCT01335932|141319812|OTHER|||||||0.31|||||||t-test, 2 sided|||||||0.31
70914330|NCT01335932|141319813|OTHER|||||||0.96|||||||t-test, 2 sided|||||||0.96
70914331|NCT01335932|141319814|OTHER|||||||0.63|||||||t-test, 2 sided|||||||0.63
70914332|NCT01335932|141319815|OTHER|||||||0.51|||||||t-test, 2 sided|||||||0.51
70914333|NCT01335932|141319816|OTHER|||||||0.12|||||||t-test, 2 sided|||||||0.12
70914334|NCT01335932|141319817|OTHER|||||||0.13|||||||t-test, 2 sided|||||||0.13
70914335|NCT01335932|141319818|OTHER|||||||0.008|||||||t-test, 2 sided|||||||0.008
70914336|NCT01335932|141319819|OTHER|||||||0.64|||||||t-test, 2 sided|||||||0.64
70914337|NCT01335932|141319820|OTHER|||||||0.24|||||||t-test, 2 sided|||||||0.24
70914338|NCT01335932|141319821|OTHER|||||||0.76|||||||t-test, 2 sided|||||||0.76
70914339|NCT01335932|141319822|OTHER|||||||0.45|||||||t-test, 2 sided|||||||0.45
70914340|NCT01335932|141319823|OTHER|||||||0.92|||||||t-test, 2 sided|||||||0.92
70914341|NCT01335932|141319824|OTHER|||||||0.94|||||||t-test, 2 sided|||||||0.94
70914342|NCT01335932|141319825|OTHER|||||||0.37|||||||t-test, 2 sided|||||||0.37
70914343|NCT01335932|141319826|OTHER|||||||0.8|||||||t-test, 2 sided|||||||0.80
70914344|NCT01335932|141319827|OTHER|||||||0.93|||||||t-test, 2 sided|||||||0.93
70914345|NCT01335932|141319828|OTHER|||||||0.93|||||||t-test, 2 sided|||||||0.93
70914346|NCT01335932|141319829|OTHER|||||||0.45|||||||t-test, 2 sided|||||||0.45
70914347|NCT00952718|141319863|SUPERIORITY|||||||0.005||||||p-value for MIP was adjusted by linear regression model.|Regression, Linear|||||||0.005
70914348|NCT00952718|141319863|SUPERIORITY|||||||0.038||||||adjusted p for MEP by linear regression|Regression, Linear|||||||0.038
70914349|NCT00952718|141319864|SUPERIORITY|||||||0.063|||||||Regression, Linear|||||||0.063
70914350|NCT00952718|141319865|SUPERIORITY|||||||0.269|||||||Regression, Linear|||||||0.269
70914351|NCT02476890|141319870|OTHER||Mean Difference (Final Values)|0.01||||0.9666|TWO_SIDED|95.0|-0.6|0.7|||Mixed Models Analysis|||C2 Response/Healthy||0.7|-0.6|0.9666
70914352|NCT02476890|141319870|OTHER||Mean Difference (Final Values)|-0.22||||0.5993|TWO_SIDED|95.0|-1.1|0.6|||Mixed Models Analysis|||C5 Response/Healthy||0.6|-1.1|0.5993
70914353|NCT02476890|141319870|OTHER||Mean Difference (Final Values)|0.32||||0.2823|TWO_SIDED|95.0|-0.3|0.9|||Mixed Models Analysis|||C2 Response/Chronic Cough||0.9|-0.3|0.2823
70914354|NCT02476890|141319870|OTHER||Mean Difference (Final Values)|0.25||||0.4287|TWO_SIDED|95.0|-0.4|0.9|||Mixed Models Analysis|||C5 Response/Chronic Cough||0.9|-0.4|0.4287
70914355|NCT02476890|141319871|OTHER||Mean Difference (Final Values)|0.56||||0.1771|TWO_SIDED|95.0|-0.3|1.4|||Mixed Models Analysis|||C2 Response/Healthy||1.4|-0.3|0.1771
70914356|NCT02476890|141319871|OTHER||Mean Difference (Final Values)|0.3||||0.5473|TWO_SIDED|95.0|-0.7|1.3|||Mixed Models Analysis|||C5 Response/Healthy||1.3|-0.7|0.5473
70914357|NCT02476890|141319871|OTHER||Mean Difference (Final Values)|0.23||||0.5169|TWO_SIDED|95.0|-0.5|1.0|||Mixed Models Analysis|||C2 Response/Chronic Cough||1.0|-0.5|0.5169
70914358|NCT02476890|141319871|OTHER||Mean Difference (Final Values)|0.28||||0.4243|TWO_SIDED|95.0|-0.4|1.0|||Mixed Models Analysis|||C5 Response/Chronic Cough||1.0|-0.4|0.4243
70914359|NCT02476890|141319872|OTHER||Mean Difference (Final Values)|0.89||||0.1125|TWO_SIDED|95.0|-0.2|2.0|||Mixed Models Analysis|||C2 Response/Healthy||2.0|-0.2|0.1125
70914360|NCT02476890|141319872|OTHER||Mean Difference (Final Values)|0.88||||0.0029|TWO_SIDED|95.0|0.4|1.4|||Mixed Models Analysis|||C5 Response/Healthy||1.4|0.4|0.0029
70914361|NCT02476890|141319872|OTHER||Mean Difference (Final Values)|1.54||||0.0006|TWO_SIDED|95.0|0.7|2.4|||Mixed Models Analysis|||C2 Response/Chronic Cough||2.4|0.7|0.0006
70914362|NCT02476890|141319872|OTHER||Mean Difference (Final Values)|1.3||||0.0067|TWO_SIDED|95.0|0.4|2.2|||Mixed Models Analysis|||C5 Response/Chronic Cough||2.2|0.4|0.0067
70914363|NCT02476890|141319873|OTHER||Mean Difference (Final Values)|0.38|||<|0.0001|TWO_SIDED|95.0|0.2|0.5|||Mixed Models Analysis|||C2 Response/Healthy||0.5|0.2|< 0.0001
70914364|NCT02476890|141319873|OTHER||Mean Difference (Final Values)|0.23||||0.1798|TWO_SIDED|95.0|-0.1|0.6|||Mixed Models Analysis|||C5 Response/Healthy||0.6|-0.1|0.1798
70914365|NCT02476890|141319873|OTHER||Mean Difference (Final Values)|0.3||||0.0011|TWO_SIDED|95.0|0.1|0.5|||Mixed Models Analysis|||C2 Response/Chronic Cough||0.5|0.1|0.0011
70914366|NCT02476890|141319873|OTHER||Mean Difference (Final Values)|0.28||||0.0023|TWO_SIDED|95.0|0.1|0.4|||Mixed Models Analysis|||C5 Response/Chronic Cough||0.4|0.1|0.0023
70914367|NCT02476890|141319874|OTHER||Mean Difference (Final Values)|-18.0||||0.0037|TWO_SIDED|95.0|-29.8|-6.2|||Mixed Models Analysis|||Cough Severity VAS Analysis||-6.2|-29.8|0.0037
70914368|NCT02476890|141319875|OTHER||Mean Difference (Final Values)|-18.0||||0.002|TWO_SIDED|95.0|-29.1|-7.0|||Mixed Models Analysis|||Urge to Cough VAS Analysis||-7.0|-29.1|0.0020
70914369|NCT02476890|141319876|OTHER||Mean Difference (Final Values)|-3.6||||0.0075|TWO_SIDED|95.0|-6.2|-1.0|||Mixed Models Analysis|||Cough Frequency Analysis||-1.0|-6.2|0.0075
70914370|NCT00835380|141319879|SUPERIORITY_OR_OTHER||Seroconversion Rate|99.0||||||95.0|89.0|99.0||||||||99|89|
70914371|NCT03247543|141319881|SUPERIORITY||Least Square Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|2.05||0.0038|TWO_SIDED|95.0|-10.0|-1.9|||Mixed Models for Repeated Measures|||||-1.9|-10.0|0.0038
70914372|NCT03247543|141319881|SUPERIORITY||Least Square Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|2.11||0.0063|TWO_SIDED|95.0|-9.9|-1.7|||Mixed Models for Repeated Measures|||||-1.7|-9.9|0.0063
70914373|NCT03247543|141319882|SUPERIORITY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.0028|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.2|-0.8|0.0028
70914374|NCT03247543|141319882|SUPERIORITY||Least Square Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0099|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.1|-0.8|0.0099
70914375|NCT03247543|141319883|SUPERIORITY||Least Square Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|1.39||0.0064|TWO_SIDED|95.0|-6.5|-1.1|||ANCOVA|||||-1.1|-6.5|0.0064
70914376|NCT03247543|141319883|SUPERIORITY||Least Square Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|1.46||0.0917|TWO_SIDED|95.0|-5.3|0.4|||ANCOVA|||||0.4|-5.3|0.0917
70914377|NCT03247543|141319884|SUPERIORITY||Least Square Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.059||0.0651|TWO_SIDED|95.0|-0.22|0.01|||ANCOVA|||||0.01|-0.22|0.0651
70914378|NCT03247543|141319884|SUPERIORITY||Least Square Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.061||0.168|TWO_SIDED|95.0|-0.2|0.04|||ANCOVA|||||0.04|-0.20|0.1680
70914379|NCT03247543|141319885|SUPERIORITY||Risk Difference (RD)|10.1||||0.1316|TWO_SIDED|95.0|-2.9|23.1|||Regression, Logistic|||||23.1|-2.9|0.1316
70914380|NCT03247543|141319885|SUPERIORITY||Risk Difference (RD)|15.4||||0.0276|TWO_SIDED|95.0|2.0|28.9|||Regression, Logistic|||||28.9|2.0|0.0276
70914381|NCT03247543|141319886|SUPERIORITY||Least Square Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|2.7||0.2128|TWO_SIDED|95.0|-8.7|1.9|||ANCOVA|||||1.9|-8.7|0.2128
70914382|NCT03247543|141319886|SUPERIORITY||Least Square Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|2.83||0.0409|TWO_SIDED|95.0|-11.3|-0.2|||ANCOVA|||||-0.2|-11.3|0.0409
70914383|NCT03247543|141319887|SUPERIORITY||Least Square Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|1.07||0.002|TWO_SIDED|95.0|-5.4|-1.2|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-1.2|-5.4|0.0020
70914384|NCT03247543|141319887|SUPERIORITY||Least Square Mean Difference|-3.2|STANDARD_ERROR_OF_MEAN|1.09||0.0039|TWO_SIDED|95.0|-5.3|-1.0|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-1.0|-5.3|0.0039
70914385|NCT03247543|141319887|SUPERIORITY||Least Square Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|1.05||0.0087|TWO_SIDED|95.0|-4.8|-0.7|||ANCOVA|||This analysis pertains to the Inattention subscale score||-0.7|-4.8|0.0087
70914386|NCT03247543|141319887|SUPERIORITY||Least Square Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.09||0.0248|TWO_SIDED|95.0|-4.6|-0.3|||ANCOVA|||This analysis pertains to the Inattention subscale score||-0.3|-4.6|0.0248
70914387|NCT03247543|141319888|SUPERIORITY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.43||0.7003|TWO_SIDED|95.0|-3.3|2.2|||ANCOVA|||||2.2|-3.3|0.7003
70914388|NCT03247543|141319888|SUPERIORITY||Least Square Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.45||0.1602|TWO_SIDED|95.0|-4.9|0.8|||ANCOVA|||||0.8|-4.9|0.1602
70914389|NCT03247543|141319889|SUPERIORITY|||||||0.0236|||||||Chi-squared|||This analysis pertains to Week 1 of treatment.||||0.0236
70914390|NCT03247543|141319889|SUPERIORITY|||||||0.0505|||||||Chi-squared|||This analysis pertains to Week 2 of treatment.||||0.0505
70914391|NCT03247543|141319889|SUPERIORITY|||||||0.1225|||||||Chi-squared|||This analysis pertains to Week 3 of treatment.||||0.1225
70914392|NCT03247543|141319889|SUPERIORITY|||||||0.0254|||||||Chi-squared|||This analysis pertains to Week 4 of treatment.||||0.0254
70914393|NCT03247543|141319889|SUPERIORITY|||||||0.0261|||||||Chi-squared|||This analysis pertains to Week 5 of treatment.||||0.0261
70914394|NCT03247543|141319889|SUPERIORITY|||||||0.0037|||||||Chi-squared|||This analysis pertains to Week 6 of treatment.||||0.0037
70914395|NCT03247543|141319889|SUPERIORITY|||||||0.0385|||||||Chi-squared|||This analysis pertains to Week 7 of treatment.||||0.0385
70914396|NCT03247543|141319889|SUPERIORITY|||||||0.0956|||||||Chi-squared|||This analysis pertains to Week 8 of treatment.||||0.0956
70914397|NCT03247543|141319889|SUPERIORITY|||||||0.0962|||||||Chi-squared|||This analysis pertains to Week 1 of treatment.||||0.0962
70914398|NCT03247543|141319889|SUPERIORITY|||||||0.0744|||||||Chi-squared|||This analysis pertains to Week 2 of treatment.||||0.0744
70914399|NCT03247543|141319889|SUPERIORITY|||||||0.0218|||||||Chi-squared|||This analysis pertains to Week 3 of treatment.||||0.0218
70914400|NCT03247543|141319889|SUPERIORITY|||||||0.115|||||||Chi-squared|||This analysis pertains to Week 4 of treatment.||||0.1150
70914401|NCT03247543|141319889|SUPERIORITY|||||||0.1086|||||||Chi-squared|||This analysis pertains to Week 5 of treatment.||||0.1086
70914402|NCT03247543|141319889|SUPERIORITY|||||||0.0082|||||||Chi-squared|||This analysis pertains to Week 6 of treatment.||||0.0082
70914403|NCT03247543|141319889|SUPERIORITY|||||||0.2326|||||||Chi-squared|||This analysis pertains to Week 7 of treatment.||||0.2326
70914404|NCT03247543|141319889|SUPERIORITY|||||||0.0883|||||||Chi-squared|||This analysis pertains to Week 8 of treatment.||||0.0883
70914405|NCT01097343|141319890|SUPERIORITY_OR_OTHER||||||=|0.02|TWO_SIDED|95.0|||||Chi-squared|||A sample of size of 50 patients for the cross-over study was chosen because it provided 80% power to detect a decrease in the rate of high on-clopidogrel platelet reactivity (HPR, defined as \>230 PRU) from 75% to 46% with high dose clopidogrel, with a two-sided alpha of 0.05||||=0.02
70914406|NCT02059980|141319891|SUPERIORITY||||||=|0.56|||||||Mixed Models Analysis|||It was calculated that 30 participants rnadomized in a 1:1 fashion between the 2 arms would have .90 power to detect a large effect (f=.40), but is somewhat underpowered to detect a medium effect (f=.25) between the two groups. Sample size was determined using a repeated-measures ANOVA test (α = .05, a correlation of .5 among repeated measures, and a nonsphericity correction of .6), considering the design effect and potential patient attrition (=25%).||||= 0.56
70914407|NCT02059980|141319892|SUPERIORITY||||||=|0.98|||||||Mixed Models Analysis|||It was calculated that 30 participants randomized in a 1:1 fashion between the 2 arms would have .90 power to detect a large effect (f=.40), but is somewhat underpowered to detect a medium effect (f=.25) between the two groups. Sample size was determined using a repeated-measures ANOVA test (α = .05, a correlation of .5 among repeated measures, and a nonsphericity correction of .6), considering the design effect and potential patient attrition (=25%).||||=.98
70914408|NCT00414206|141319961|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANCOVA|||||||>0.05
70914409|NCT01227707|141319962|SUPERIORITY_OR_OTHER|||||||1|||||||one sample binomial test|||||||1.00
70914410|NCT03028363|141319980|OTHER|||||||0.343|||||||ANCOVA|Ranked ANCOVA, Markov Chain Monte Carlo (MCMC) Multiple Imputation||||||0.3430
70914411|NCT03028363|141319981|OTHER|||||||0.126|||||||ANCOVA|Ranked ANCOVA, Markov Chain Monte Carlo (MCMC) Multiple Imputation||||||0.1260
70914412|NCT03028363|141319982|OTHER|||||||0.5247|||||||Regression, Logistic|Logistic Regression (Firth's Penalized Likelihood), MCMC Multiple Imputation||||||0.5247
70914413|NCT00605033|141320033|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was defined as a lower bound of the two-sided 95% confidence interval of the proportion difference greater than -0.15.|Proportion difference|-0.054|||||TWO_SIDED|95.0|-0.142|0.034|||Binomial approximation|||||0.034|-0.142|
70914414|NCT05298111|141320125|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
70914415|NCT05298111|141320126|SUPERIORITY||||||<|0.001|||||||Paired t-test|||||||< 0.001
70914416|NCT05298111|141320127|SUPERIORITY||||||<|0.001|||||||Sign test|||||||< 0.001
70914417|NCT05298111|141320128|SUPERIORITY|||||||0.001|||||||Sign test|||||||0.001
70914418|NCT05298111|141320129|SUPERIORITY|||||||0.894|||||||Paired t-test|||||||0.894
70914419|NCT05298111|141320130|SUPERIORITY|||||||0.629|||||||Paired t-test|||||||0.629
70914420|NCT05298111|141320131|SUPERIORITY|||||||0.653|||||||Paired t-test|||||||0.653
70914421|NCT05298111|141320132|SUPERIORITY|||||||0.624|||||||Paired t-test|||||||0.624
70914422|NCT05298111|141320133|SUPERIORITY|||||||0.414|||||||Paired t-test|||||||0.414
70914423|NCT05298111|141320134|SUPERIORITY|||||||0.105|||||||Paired t-test|||||||0.105
70914424|NCT01185522|141320157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.235|TWO_SIDED|95.0|0.45|1.22|||Univariate logistic regression model|||Comparison between genders: women and men.||1.22|0.45|0.235
70914425|NCT01185522|141320157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.331|TWO_SIDED|95.0|0.55|1.22|||Univariate logistic regression model|||Comparison between Age: \<= 55 years and \> 55 years||1.22|0.55|0.331
70914426|NCT01185522|141320157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.05|TWO_SIDED|95.0|1.0|2.23|||Univariate logistic regression model|||Comparison between time since initial diagnosis: \>= 10 years and \< 10 years||2.23|1.00|0.050
70914427|NCT01185522|141320157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.144|TWO_SIDED|95.0|0.88|2.46|||Univariate logistic regression model|||Comparison between participants without erosive rheumatoid arthritis (RA) and participants with erosive RA||2.46|0.88|0.144
70914428|NCT01185522|141320157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74||||0.01|TWO_SIDED|95.0|1.14|2.65|||Univariate logistic regression model|||Comparison between DAS-28 score: \<= 5.1 and DAS-28 \>5.1||2.65|1.14|0.010
70914429|NCT01185522|141320157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.119|TWO_SIDED|95.0|0.92|2.1|||Univariate logistic regression model|||Comparison between ESR: \<= 28 mm/h and \> 28 mm/h||2.10|0.92|0.119
70914430|NCT01185522|141320157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.265|TWO_SIDED|95.0|0.81|2.13|||Univariate logistic regression model|||Comparison between number of participants without anemia and number of participants with anemia||2.13|0.81|0.265
70914431|NCT01185522|141320157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.511|TWO_SIDED|95.0|0.77|1.71|||Univariate logistic regression model|||Comparison between dose of corticosteroids: \<= 5 mg and \> 5 mg||1.71|0.77|0.511
70914432|NCT01185522|141320157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.153|TWO_SIDED|95.0|0.9|2.0|||Univariate logistic regression model|||Comparison between HAQ score: \<= 1.5 and \> 1.5||2.00|0.90|0.153
70914433|NCT01185522|141320157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19|||<|0.001|TWO_SIDED|95.0|1.45|3.31|||Univariate logistic regression model|||Comparison between VAS patient: fatigue \<= 66 and \> 66||3.31|1.45|<0.001
70914434|NCT01185522|141320157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04|||<|0.001|TWO_SIDED|95.0|1.35|3.08|||Univariate logistic regression model|||Comparison between VAS patient: pain \<= 66 and \> 66||3.08|1.35|<0.001
70914435|NCT01185522|141320157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.54||||0.261|TWO_SIDED|95.0|0.86|2.75|||Univariate logistic regression model|||Comparison between VAS patient (quality of sleep) score: \<=30 score and 30 - 59 score||2.75|0.86|0.261
70914436|NCT01185522|141320157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.261|TWO_SIDED|95.0|0.67|2.05|||Univariate logistic regression model|||Comparison between VAS patient (quality of sleep) score: \<= 30 and 59 - 77||2.05|0.67|0.261
70914437|NCT01185522|141320157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.261|TWO_SIDED|95.0|0.95|2.89|||Univariate logistic regression model|||Comparison between VAS patient (quality of sleep) score: \<= 30 and \> 77||2.89|0.95|0.261
70914438|NCT01185522|141320157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.08|||<|0.001|TWO_SIDED|95.0|1.38|3.14|||Univariate logistic regression model|||Comparison between VAS patient: global assessment score: \<= 67 and \> 67||3.14|1.38|<0.001
70914439|NCT01185522|141320157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.28|||<|0.001|TWO_SIDED|95.0|1.5|3.47|||Univariate logistic regression model|||Comparison between SF36 vitality score: \> 33 and \<= 33||3.47|1.50|< 0.001
70914440|NCT01185522|141320157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.399|TWO_SIDED|95.0|0.6|1.93|||Univariate logistic regression model|||Comparison between HADS score: Anxiety (No case) and HADS score: Anxiety (Doubtful case)||1.93|0.60|0.399
70914441|NCT01185522|141320157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.399|TWO_SIDED|95.0|0.48|1.26|||Univariate logistic regression model|||Comparison between HADS score: Anxiety (No case) and HADS score: Anxiety (Certain case)||1.26|0.48|0.399
70914442|NCT01185522|141320157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.858|TWO_SIDED|95.0|0.65|1.81|||Univariate logistic regression model|||Comparison between HADS score: Depression (No Case) and HADS score: Depression (Doubtful case)||1.81|0.65|0.858
70914443|NCT01185522|141320157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.858|TWO_SIDED|95.0|0.57|1.52|||Univariate logistic regression model|||Comparison between HADS score: Depression (No Case) and HADS score: Depression (Certain case)||1.52|0.57|0.858
70914444|NCT01185522|141320157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63||||0.036|TWO_SIDED|95.0|1.03|2.58|||Multivariate logistic regression model|||Comparison between time since initial diagnosis: \>= 10 years and \< 10 years||2.58|1.03|0.036
70914445|NCT01185522|141320158|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.004|TWO_SIDED|95.0|1.05|1.28|||Univariate logistic regression model|||Predictive factor: C-Reactive Protein||1.28|1.05|0.004
70914446|NCT01185522|141320158|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.013|TWO_SIDED|95.0|1.03|1.27|||Multivariate logistic regression model|||Predictive factor: C-Reactive Protein||1.27|1.03|0.013
70914447|NCT01185522|141320159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.253|TWO_SIDED|95.0|0.99|1.05|||Univariate logistic regression model|||Predictive factor: Tender joint||1.05|0.99|0.253
70914448|NCT01185522|141320159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.021|TWO_SIDED|95.0|1.01|1.09|||Univariate logistic regression model|||Predictive factor : Swollen joint||1.09|1.01|0.021
70914449|NCT01803646|141320183|SUPERIORITY||Mean Difference (Net)|-0.17||||0.32|TWO_SIDED|95.0|-0.51|0.17|||Mixed Models Analysis|||||0.17|-0.51|0.32
70914450|NCT01803646|141320184|SUPERIORITY||Mean Difference (Net)|-0.79||||0.63|TWO_SIDED|95.0|-4.0|2.4|||Mixed Models Analysis|||||2.4|-4|0.63
70914451|NCT01803646|141320185|SUPERIORITY|||||||0.821|||||||Fisher Exact|||Analysis for air conduction||||0.821
70914452|NCT01803646|141320185|SUPERIORITY|||||||1|||||||Fisher Exact|||Analysis for bone conduction||||1.0
70914453|NCT03923491|141320195|SUPERIORITY||Slope|-0.55|STANDARD_ERROR_OF_MEAN|4.69||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 total score controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
70914454|NCT03923491|141320195|SUPERIORITY||Slope|-0.35|STANDARD_ERROR_OF_MEAN|0.49||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 total vegetable component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
70914455|NCT03923491|141320195|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.88||0.2|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 greens and beans component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||0.20
70914456|NCT03923491|141320195|SUPERIORITY||Slope|1.71|STANDARD_ERROR_OF_MEAN|0.67||0.2|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 total fruit component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||0.20
70970692|NCT00531752|141447063|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4684|STANDARD_ERROR_OF_MEAN|0.1791||0.0119|TWO_SIDED|80.0|-0.7012|-0.2356|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.2356|-0.7012|0.0119
71092928|NCT02107898|141692380|SUPERIORITY_OR_OTHER||LS Mean Difference|6.3|||<|0.0001|TWO_SIDED|95.0|3.6|9.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||9.0|3.6|<0.0001
70914457|NCT03923491|141320195|SUPERIORITY||Slope|2.14|STANDARD_ERROR_OF_MEAN|0.83||0.19|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 whole fruit component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||0.19
70914458|NCT03923491|141320195|SUPERIORITY||Slope|0.83|STANDARD_ERROR_OF_MEAN|1.1||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 whole grain component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.0
70914459|NCT03923491|141320195|SUPERIORITY||Slope|-0.9|STANDARD_ERROR_OF_MEAN|0.85||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 total dairy component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.0
70914460|NCT03923491|141320195|SUPERIORITY||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.42||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 total protein foods component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
70914461|NCT03923491|141320195|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.85||-0.12|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 seafood and plant protein component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||-0.12
70914462|NCT03923491|141320195|SUPERIORITY||Slope|-0.31|STANDARD_ERROR_OF_MEAN|1.12||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 fatty acid component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
70914463|NCT03923491|141320195|SUPERIORITY||Slope|-2.09|STANDARD_ERROR_OF_MEAN|0.97||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 sodium component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
70914464|NCT03923491|141320195|SUPERIORITY||Slope|-0.8|STANDARD_ERROR_OF_MEAN|1.16||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 refined grains component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
70914465|NCT03923491|141320195|SUPERIORITY||Slope|-0.28|STANDARD_ERROR_OF_MEAN|1.13||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 added sugar component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
70914466|NCT03923491|141320195|SUPERIORITY||Slope|-0.52|STANDARD_ERROR_OF_MEAN|0.86||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||||||1.00
70914467|NCT02174562|141320198|SUPERIORITY||Risk Ratio (RR)|1.21||||0.31|TWO_SIDED|95.0|0.84|1.75||0.05 was the a priori level of significance.|Poisson regression with robust SEs||PC-OT is the numerator, Enhanced Usual care is the denominator|Null hypothesis is that the Relative Risk of reduction of HbA1C \>=0.5 for PCOT vs EUC is 1.||1.75|0.84|0.31
70914468|NCT02174562|141320199|SUPERIORITY|||||||0.87|||||||Mixed Models Analysis|P-value is for comparison of least squares means for period 2 (months 4-6).||Mixed effects linear regression was used to model the percentage of doses taken each month. Fixed effects were period (1-3 months, 4-6 months, 7-9 months, 10-12 months), randomization group, randomization by period interaction, stratification group, age, and run-in percentage doses taken. The outcome was transformed using the arcsin-square root transformation prior to analysis. A first-order autoregressive correlation structure was assumed.||||0.87
70914469|NCT03095508|141320239|SUPERIORITY|||||||0.446|||||||Fisher Exact|||||||0.446
70914470|NCT03095508|141320241|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
70914471|NCT03095508|141320242|SUPERIORITY|||||||0.145|||||||t-test, 2 sided|||||||0.145
70914472|NCT03095508|141320243|SUPERIORITY|||||||0.188|||||||Wilcoxon (Mann-Whitney)|||||||0.188
70914473|NCT03095508|141320244|NON_INFERIORITY|non-inferiority margin 14.5% absolute difference between percentages in group A and B|Risk Difference (RD)|0.14||||1e-05|TWO_SIDED|95.0|0.03|0.24||p- value for superiority: 0.021|Fisher Exact|||p1=proportion of patients without sore throat at Day 4 in Arm A p2=proportion of patients without sore throat at Day 4 in Arm B Н0: p1 - p2 ≤ -0.145||0.24|0.03|0.00001
70914474|NCT00545844|141320256|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71092929|NCT01401166|141692408|SUPERIORITY_OR_OTHER||Estimated Proportion|0.957|||||TWO_SIDED|95.0|0.903|0.986|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding exact binomial confidence interval (CI) were determined.|||0.986|0.903|
70914475|NCT00545844|141320257|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70914476|NCT00545844|141320258|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||McNemar-Bowker|||McNemar-Bowker test is McNemar chi-squared statistic for binary matched pairs, with Bowker chi-squared fit test of symmetry model (tests all rows of data) (cf. Agresti, 2007)||||<0.001
70914477|NCT00545844|141320259|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||McNemar-Bowker|||McNemar-Bowker test is McNemar chi-squared statistic for binary matched pairs, with Bowker chi-squared fit test of symmetry model (tests all rows of data) (cf. Agresti, 2007)||||<0.001
70914478|NCT00545844|141320260|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||McNemar-Bowker|||McNemar-Bowker test is McNemar chi-squared statistic for binary matched pairs, with Bowker chi-squared fit test of symmetry model (tests all rows of data) (cf. Agresti, 2007)||||<0.001
70914479|NCT00094809|141320300|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.19|||<|0.0001||95.0|0.1|0.37|||Mantel Haenszel|Adjusted for chemotherapy regimen|Common odds ratio of the pegfilgrastim group compared to the placebo group|||0.37|0.10|<0.0001
70914480|NCT00094809|141320301|SUPERIORITY_OR_OTHER||Treatment difference|-18.0|||<|0.0001||95.0|-26.2|-9.8|||Mantel Haenszel|Adjusted for chemotherapy regimen|Treatment difference in percentage of participants (pegfilgrastim group - placebo group)|||-9.8|-26.2|<0.0001
70914481|NCT00094809|141320302|SUPERIORITY_OR_OTHER||Treatment difference|-12.0||||0.0646||95.0|-23.7|0.5|||Mantel Haenszel|Adjusted for chemotherapy regimen|Treatment difference in percentage of participants (pegfilgrastim group - placebo group)|||0.5|-23.7|0.0646
70914482|NCT00094809|141320303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||0.0384||95.0|0.07|1.0|||Mantel Haenszel|Adjusted for chemotherapy regimen|Common odds ratio of pegfilgrastim group compared to placebo group|||1.00|0.07|0.0384
70914483|NCT00094809|141320304|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.5514||95.0|0.26|2.04|||Mantel Haenszel|Adjusted for chemotherapy regimen|Common odds ratio for pegfilgrastim group compared to placebo group|||2.04|0.26|0.5514
70914484|NCT00094809|141320306|SUPERIORITY_OR_OTHER||Treatment difference|-3.5||||0.5434||95.0|-14.8|7.8|||Mantel Haenszel|Adjusted for chemotherapy regimen|Treatment difference (pegfilgrastim group - placebo group) in the percentage of participants with a complete or partial response|||7.8|-14.8|0.5434
70914485|NCT00094809|141320307|SUPERIORITY_OR_OTHER||Treatment difference|-12.1||||||95.0|-28.1|4.0|||||Kaplan-Meier estimates of the difference in percent mortality for the pegfilgrastim group - placebo group. Median survival time was not reached for the pegfilgrastim group.|||4.0|-28.1|
70914486|NCT00094809|141320308|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.23||||0.0457||95.0|0.05|1.09|||Mantel Haenszel|Adjusted for chemotherapy regimen|Common odds ratio for pegfilgrastim group compared to placebo group|||1.09|0.05|0.0457
70914487|NCT00094809|141320309|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.3792||95.0|0.32|1.53|||Mantel Haenszel|Adjusted for chemotherapy regimen|Common odds ratio of the pegfilgrastim group compared to the placebo group|||1.53|0.32|0.3792
70914488|NCT01156116|141320365|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Mixed Models Analysis|Analyses were adjusted for age, body mass index, and ethnicity-based diabetes risk.||||||0.03
70914489|NCT01156116|141320366|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Mixed Models Analysis|Analyses were adjusted for age, body mass index, and ethnicity-based diabetes risk.||||||0.04
70914490|NCT01156116|141320367|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||Mixed Models Analysis|Analyses were adjusted for age, body mass index, and ethnicity-based diabetes risk.||||||0.009
70914491|NCT01156116|141320368|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Analyses were adjusted for age, body mass index, and ethnicity-based diabetes risk.||||||<0.001
70914492|NCT02057718|141320373|OTHER|Null hypothesis (H0): mean change from baseline to Week 13 is zero. The null hypothesis was tested for each of the 2 PFIC subgroups and overall; the change in the overall population is presented here.|Mean Difference (Net)|-23.304|STANDARD_DEVIATION|160.9748|||TWO_SIDED|95.0|-82.35|35.742||||||This analysis shows the change from baseline to Week 13 in sBA levels for the overall Modified Intent-to-treat Population. Even though a comparison of PFIC1 vs PFIC2 (overall) is noted, the results are the change from baseline for all participants and is not comparative.||35.742|-82.35|
70914493|NCT02503202|141320379|EQUIVALENCE|Lot consistency requires the 95% confidence interval of the GMT ratio of \>0.5 and ≤2.0 for the primary analysis and \>0.67 and ≤1.5 for the secondary analysis.|GMT ratio (Lot A / Lot B)|0.94|||<|0.001|TWO_SIDED|95.0|0.77|1.14||Primary analysis: a p-value \<0.025 supported the conclusion of equivalence. If equivalence was established for the 3 pairwise comparisons, the lots would be considered to be consistent.|ANOVA|||||1.14|0.77|<0.001
70914494|NCT02503202|141320379|EQUIVALENCE|Lot consistency requires the 95% confidence interval of the GMT ratio of \>0.5 and ≤2.0 for the primary analysis and \>0.67 and ≤1.5 for the secondary analysis.|GMT ratio (Lot A / Lot C)|0.88|||<|0.001|TWO_SIDED|95.0|0.71|1.09||Primary analysis: a p-value \<0.025 supported the conclusion of equivalence. If equivalence was established for the 3 pairwise comparisons, the lots would be considered to be consistent.|ANOVA|||||1.09|0.71|<0.001
70914495|NCT02503202|141320379|EQUIVALENCE|Lot consistency requires the 95% confidence interval of the GMT ratio of \>0.5 and ≤2.0 for the primary analysis and \>0.67 and ≤1.5 for the secondary analysis.|GMT ratio (Lot B / Lot C)|0.94|||<|0.001|TWO_SIDED|95.0|0.77|1.15||Primary analysis: a p-value \<0.025 supported the conclusion of equivalence. If equivalence was established for the 3 pairwise comparisons, the lots would be considered to be consistent.|ANOVA|||||1.15|0.77|<0.001
70914496|NCT02503202|141320380|OTHER||Risk Difference (RD)|1.1||||0.368|TWO_SIDED|95.0|-1.5|4.0|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|||4.0|-1.5|0.368
70914497|NCT02503202|141320380|OTHER||Risk Difference (RD)|0.0||||0.989|TWO_SIDED|95.0|-3.1|3.0|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|||3.0|-3.1|0.989
71092930|NCT01401166|141692408|SUPERIORITY_OR_OTHER||Estimated Proportion|0.964|||||TWO_SIDED|95.0|0.908|0.986|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding CI were determined using logistic regression with factors of previous Herceptin status and treatment.|||0.986|0.908|
71153901|NCT00488683|141800059|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.33|||<|0.001||95.0|||||Parametric correlation||Values from Group 1, 2 and 3 were combined for this analysis.|Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration at 12 months of age||||<0.001
70914498|NCT02503202|141320380|OTHER||Risk Difference (RD)|-1.1||||0.361|TWO_SIDED|95.0|-4.1|1.5|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|||1.5|-4.1|0.361
70914499|NCT02503202|141320380|OTHER||Risk Difference (RD)|1.2||||0.214|TWO_SIDED|95.0|-1.7|3.3|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|||3.3|-1.7|0.214
70914500|NCT02503202|141320381|OTHER||Risk Difference (RD)|4.1||||0.16|TWO_SIDED|95.0|-1.6|9.9|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|Injection site erythema||9.9|-1.6|0.160
70914501|NCT02503202|141320381|OTHER||Risk Difference (RD)|-0.1||||0.971|TWO_SIDED|95.0|-6.2|6.0|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|Injection site erythema||6.0|-6.2|0.971
70914502|NCT02503202|141320381|OTHER||Risk Difference (RD)|-4.2||||0.151|TWO_SIDED|95.0|-10.0|1.5|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|Injection site erythema||1.5|-10.0|0.151
70914503|NCT02503202|141320381|OTHER||Risk Difference (RD)|5.8||||0.016|TWO_SIDED|95.0|1.4|9.9|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|Injection site erythema||9.9|1.4|0.016
70914504|NCT02503202|141320381|OTHER||Risk Difference (RD)|-6.2||||0.12|TWO_SIDED|95.0|-14.0|1.6|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|Injection site pain||1.6|-14.0|0.120
70914505|NCT02503202|141320381|OTHER||Risk Difference (RD)|-3.5||||0.38|TWO_SIDED|94.0|-11.4|4.4|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|Injection site pain||4.4|-11.4|0.380
70914506|NCT02503202|141320381|OTHER||Risk Difference (RD)|2.7||||0.499|TWO_SIDED|95.0|-5.1|10.4|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|Injection site pain||10.4|-5.1|0.499
71092931|NCT01401166|141692408|SUPERIORITY_OR_OTHER||Estimated Proportion|0.874|||||TWO_SIDED|95.0|0.801|0.928|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding exact binomial CI were determined.|||0.928|0.801|
70914507|NCT02503202|141320381|OTHER||Risk Difference (RD)|54.9|||<|0.001|TWO_SIDED|95.0|46.2|62.3|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|Injection site pain||62.3|46.2|<0.001
70914508|NCT02503202|141320381|OTHER||Risk Difference (RD)|4.0||||0.202|TWO_SIDED|95.0|-2.2|10.3|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|Injection site swelling||10.3|-2.2|0.202
70914509|NCT02503202|141320381|OTHER||Risk Difference (RD)|-0.5||||0.878|TWO_SIDED|95.0|-7.1|6.1|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|Injection site swelling||6.1|-7.1|0.878
70914510|NCT02503202|141320381|OTHER||Risk Difference (RD)|-4.6||||0.154|TWO_SIDED|95.0|-10.9|1.7|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|Injection site swelling||1.7|-10.9|0.154
70914511|NCT02503202|141320381|OTHER||Risk Difference (RD)|13.1|||<|0.001|TWO_SIDED|95.0|7.4|18.6|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|Injection site swelling||18.6|7.4|<0.001
70914512|NCT02503202|141320382|OTHER||Risk Difference (RD)|4.6||||0.176|TWO_SIDED|95.0|-2.1|11.4|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|||11.4|-2.1|0.176
70914513|NCT02503202|141320382|OTHER||Risk Difference (RD)|-1.1||||0.769|TWO_SIDED|95.0|-8.2|6.0|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|||6.0|-8.2|0.769
70914514|NCT02503202|141320382|OTHER||Risk Difference (RD)|-5.7||||0.1|TWO_SIDED|95.0|-12.5|1.1|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|||1.1|-12.5|0.100
70914515|NCT02503202|141320382|OTHER||Risk Difference (RD)|31.4|||<|0.001|TWO_SIDED|95.0|25.6|37.5|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|||37.5|25.6|<0.001
70914516|NCT02503202|141320383|OTHER||Risk Difference (RD)|0.0||||0.983|TWO_SIDED|95.0|-4.2|4.1|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|Arthralgia||4.1|-4.2|0.983
70914517|NCT02503202|141320383|OTHER||Risk Difference (RD)|-0.8||||0.699|TWO_SIDED|95.0|-5.1|3.4|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|Arthralgia||3.4|-5.1|0.699
70914518|NCT02503202|141320383|OTHER||Risk Difference (RD)|-0.8||||0.716|TWO_SIDED|95.0|-5.1|3.5|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|Arthralgia||3.5|-5.1|0.716
70914519|NCT02503202|141320383|OTHER||Risk Difference (RD)|6.2||||0.012|TWO_SIDED|95.0|1.8|10.4|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|Arthralgia||10.4|1.8|0.012
70914520|NCT02503202|141320383|OTHER||Risk Difference (RD)|0.7||||0.677|TWO_SIDED|95.0|-2.9|4.4|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|Arthritis||4.4|-2.9|0.677
70914521|NCT02503202|141320383|OTHER||Risk Difference (RD)|1.9||||0.25|TWO_SIDED|95.0|-1.4|5.4|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|Arthritis||5.4|-1.4|0.250
70914522|NCT02503202|141320383|OTHER||Risk Difference (RD)|1.1||||0.46|TWO_SIDED|95.0|-2.1|4.5|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|Arthritis||4.5|-2.1|0.460
70914523|NCT02503202|141320383|OTHER||Risk Difference (RD)|3.1||||0.041|TWO_SIDED|95.0|0.2|6.0|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|Arthritis||6.0|0.2|0.041
70914524|NCT02503202|141320384|OTHER||Risk Difference (RD)|-1.5||||0.353|TWO_SIDED|95.0|-5.1|1.9|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|||1.9|-5.1|0.353
70914525|NCT02503202|141320384|OTHER||Risk Difference (RD)|-0.8||||0.62|TWO_SIDED|95.0|-4.2|2.5|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|||2.5|-4.2|0.620
70914526|NCT02503202|141320384|OTHER||Risk Difference (RD)|0.8||||0.663|TWO_SIDED|95.0|-2.9|4.5|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|||4.5|-2.9|0.663
70914527|NCT02503202|141320384|OTHER||Risk Difference (RD)|2.3||||0.202|TWO_SIDED|95.0|-1.8|5.7|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|||5.7|-1.8|0.202
70914528|NCT02503202|141320385|OTHER||Risk Difference (RD)|0.7||||0.483|TWO_SIDED|95.0|-1.6|3.3|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|||3.3|-1.6|0.483
70914529|NCT02503202|141320385|OTHER||Risk Difference (RD)|0.4||||0.746|TWO_SIDED|95.0|-2.2|3.0|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|||3.0|-2.2|0.746
70914530|NCT02503202|141320385|OTHER||Risk Difference (RD)|-0.4||||0.704|TWO_SIDED|95.0|-2.8|2.0|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|||2.0|-2.8|0.704
70914531|NCT02503202|141320385|OTHER||Risk Difference (RD)|1.5||||0.151|TWO_SIDED|95.0|-1.3|3.9|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|||3.9|-1.3|0.151
70914532|NCT01245439|141320408|SUPERIORITY_OR_OTHER|||||||0.929|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 1 to Visit 2||||0.929
70914533|NCT01245439|141320408|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 2 to 3||||<0.001
71092932|NCT01401166|141692408|SUPERIORITY_OR_OTHER||Estimated Proportion|0.892|||||TWO_SIDED|95.0|0.804|0.943|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding CI were determined using logistic regression with factors of previous Herceptin status and treatment.|||0.943|0.804|
70914534|NCT01245439|141320408|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 3 to Visit 4||||<0.001
70914535|NCT01245439|141320408|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 4 to Visit 5||||0.050
70914536|NCT01245439|141320408|SUPERIORITY_OR_OTHER|||||||0.165|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 5 to Visit 6||||0.165
70914537|NCT01245439|141320408|SUPERIORITY_OR_OTHER|||||||0.133|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 6 to Visit 7||||0.133
70914538|NCT01245439|141320408|SUPERIORITY_OR_OTHER|||||||0.217|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 7 to Visit 8||||0.217
70914539|NCT01245439|141320408|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 2 to Visit 8||||<0.001
70914540|NCT01245439|141320411|SUPERIORITY_OR_OTHER|||||||0.169|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 1 to Visit 2||||0.169
70914541|NCT01245439|141320411|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 2 to Visit 3||||<0.001
70914542|NCT01245439|141320411|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 3 to Visit 4||||0.053
70914543|NCT01245439|141320411|SUPERIORITY_OR_OTHER|||||||0.514|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 4 to Visit 5||||0.514
70914544|NCT01245439|141320411|SUPERIORITY_OR_OTHER|||||||0.064|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 5 to Visit 6||||0.064
70914545|NCT01245439|141320411|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 6 to Visit 7||||0.038
70914546|NCT01245439|141320411|SUPERIORITY_OR_OTHER|||||||0.064|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 7 to Visit 8||||0.064
71092933|NCT01401166|141692408|SUPERIORITY_OR_OTHER||Estimated Proportion|0.839|||||TWO_SIDED|95.0|0.76|0.9|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding exact binomial CI were determined.|||0.900|0.760|
70914547|NCT01245439|141320411|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 2 to Visit 8||||<0.001
70914548|NCT01245439|141320412|SUPERIORITY_OR_OTHER|||||||0.981|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 1 to Visit 2||||0.981
70914549|NCT01245439|141320412|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 2 to Visit 3||||<0.001
70914550|NCT01245439|141320412|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 3 to Visit 4||||0.005
70914551|NCT01245439|141320412|SUPERIORITY_OR_OTHER|||||||0.566|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 4 to Visit 5||||0.566
70914552|NCT01245439|141320412|SUPERIORITY_OR_OTHER|||||||0.264|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 5 to Visit 6||||0.264
71092934|NCT01401166|141692408|SUPERIORITY_OR_OTHER||Estimated Proportion|0.874|||||TWO_SIDED|95.0|0.776|0.933|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding CI were determined using logistic regression with factors of previous Herceptin status and treatment.|||0.933|0.776|
70914553|NCT01245439|141320412|SUPERIORITY_OR_OTHER|||||||0.126|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 6 to Visit 7||||0.126
70914554|NCT01245439|141320412|SUPERIORITY_OR_OTHER|||||||0.779|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 7 to Visit 8||||0.779
70914555|NCT01245439|141320412|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||||||<0.001
70914556|NCT01245439|141320413|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints Visit 1 to Visit 2||||0.410
70914557|NCT01245439|141320413|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 2 to Visit 3||||<0.001
70914558|NCT01245439|141320413|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 3 to Visit 4||||<0.001
70914559|NCT01245439|141320413|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 4 to Visit 5||||0.021
70914560|NCT01245439|141320413|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 5 to Visit 6||||0.003
70914561|NCT01245439|141320413|SUPERIORITY_OR_OTHER|||||||0.827|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 6 to Visit7||||0.827
70914562|NCT01245439|141320413|SUPERIORITY_OR_OTHER|||||||0.093|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 7 to Visit 8||||0.093
70914563|NCT01245439|141320413|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 2 to Visit 8||||<0.001
70914564|NCT01245439|141320413|SUPERIORITY_OR_OTHER|||||||0.792|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 1 to Visit 2||||0.792
70914565|NCT01245439|141320413|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 2 to Visit 3||||<0.001
70914566|NCT01245439|141320413|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 3 to Visit 4||||0.002
70914567|NCT01245439|141320413|SUPERIORITY_OR_OTHER|||||||0.374|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 4 to Visit 5||||0.374
70914568|NCT01245439|141320413|SUPERIORITY_OR_OTHER|||||||0.518|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 5 to Visit 6||||0.518
70914569|NCT01245439|141320413|SUPERIORITY_OR_OTHER|||||||0.744|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 6 to Visit 7||||0.744
70914570|NCT01245439|141320413|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 7 to Visit 8||||0.048
70914571|NCT01245439|141320413|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 2 to Visit 8||||<0.001
70914572|NCT01245439|141320414|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 2 to Visit 3||||<0.001
70914573|NCT01245439|141320414|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 3 to Visit 4||||<0.001
71092935|NCT01401166|141692408|SUPERIORITY_OR_OTHER||Estimated Proportion|0.885|||||TWO_SIDED|95.0|0.811|0.937|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding exact binomial CI were determined.|||0.937|0.811|
70914574|NCT01245439|141320414|SUPERIORITY_OR_OTHER|||||||0.075|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 4 to Visit 5||||0.075
70914575|NCT01245439|141320414|SUPERIORITY_OR_OTHER|||||||0.119|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 5 to Visit 6||||0.119
70914576|NCT01245439|141320414|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 6 to Visit 7||||0.007
70914577|NCT01245439|141320414|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 7 to Visit 8||||0.047
70914578|NCT01245439|141320414|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 2 to Visit 8||||<0.001
70914579|NCT01245439|141320414|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 2 to Visit 3||||<0.001
70914580|NCT01245439|141320414|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 3 to Visit 4||||<0.001
70914581|NCT01245439|141320414|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 4 to Visit 5||||0.001
70914582|NCT01245439|141320414|SUPERIORITY_OR_OTHER|||||||0.084|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 5 to Visit 6||||0.084
70914583|NCT01245439|141320414|SUPERIORITY_OR_OTHER|||||||0.272|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 6 to Visit 7||||0.272
70914584|NCT01245439|141320414|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 7 to Visit 8||||0.020
70914585|NCT01245439|141320414|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 2 to Visit 8||||<0.001
70914586|NCT01245439|141320415|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 2 to Visit 3||||<0.001
70914587|NCT01245439|141320415|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 3 to Visit 4||||<0.001
70914588|NCT01245439|141320415|SUPERIORITY_OR_OTHER|||||||0.254|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 4 to Visit 5||||0.254
70914589|NCT01245439|141320415|SUPERIORITY_OR_OTHER|||||||0.138|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 5 to Visit 6||||0.138
70914590|NCT01245439|141320415|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 6 to Visit 7||||0.002
70914591|NCT01245439|141320415|SUPERIORITY_OR_OTHER|||||||0.104|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 7 to Visit 8||||0.104
70914592|NCT01245439|141320415|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 2 to Visit 8||||<0.001
70914593|NCT01245439|141320416|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 2 to Visit 3||||<0.001
70914594|NCT01245439|141320416|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 3 to Visit 4||||0.002
70914595|NCT01245439|141320416|SUPERIORITY_OR_OTHER|||||||0.078|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 4 to Visit 5||||0.078
70914596|NCT01245439|141320416|SUPERIORITY_OR_OTHER|||||||0.349|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 5 to Visit 6||||0.349
70914597|NCT01245439|141320416|SUPERIORITY_OR_OTHER|||||||0.722|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 6 to Visit 7||||0.722
70914598|NCT01245439|141320416|SUPERIORITY_OR_OTHER|||||||0.224|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 7 to Visit 8||||0.224
70914599|NCT03525119|141320424|NON_INFERIORITY|As per predefined criteria in protocol the non-inferiority was established only between group 1 and group 3. Non-inferiority of HAV+TDV to HAV was established if the upper bound of the 95% CI was less than 10%.|Seroprotection Rate Difference|-1.68|||||TWO_SIDED|95.0|-8.91|4.28||||||||4.28|-8.91|
70914600|NCT00383188|141320453|SUPERIORITY||Difference in percentage|8.05|STANDARD_ERROR_OF_MEAN|7.97||0.3131|TWO_SIDED|95.0|-7.565|23.664|||Chi-squared|||||23.664|-7.565|0.3131
70914601|NCT00383188|141320453|SUPERIORITY||Difference in percentage|10.81|STANDARD_ERROR_OF_MEAN|7.86||0.1719|TWO_SIDED|95.0|-4.602|26.224|||Chi-squared|||||26.224|-4.602|0.1719
70914602|NCT00383188|141320453|SUPERIORITY||Difference in percentage|9.83|STANDARD_ERROR_OF_MEAN|9.16||0.2783|TWO_SIDED|95.0|-8.123|27.799|||Chi-squared|||||27.799|-8.123|0.2783
70914603|NCT00383188|141320453|SUPERIORITY||Difference in percentage|8.92|STANDARD_ERROR_OF_MEAN|9.43||0.3381|TWO_SIDED|95.0|-9.566|27.404|||Chi-squared|||||27.404|-9.566|0.3381
70914604|NCT00383188|141320454|SUPERIORITY||Difference in percentage|1.04|STANDARD_ERROR_OF_MEAN|5.96||0.8619|TWO_SIDED|90.0|-8.733|10.845|||Chi-squared|||Week 1||10.845|-8.733|0.8619
70914605|NCT00383188|141320454|SUPERIORITY||Difference in percentage|7.24|STANDARD_ERROR_OF_MEAN|6.33||0.2546|TWO_SIDED|90.0|-3.176|17.651|||Chi-squared|||Week 1||17.651|-3.176|0.2546
70914606|NCT00383188|141320454|SUPERIORITY||Difference in percentage|14.02|STANDARD_ERROR_OF_MEAN|7.96||0.0644|TWO_SIDED|90.0|0.921|27.115|||Chi-squared|||Week 1||27.115|0.921|0.0644
70914607|NCT00383188|141320454|SUPERIORITY||Difference in percentage|1.5|STANDARD_ERROR_OF_MEAN|7.07||0.8304|TWO_SIDED|90.0|-10.13|13.125|||Chi-squared|||Week 1||13.125|-10.13|0.8304
70914608|NCT00383188|141320454|SUPERIORITY||Difference in percentage|6.11|STANDARD_ERROR_OF_MEAN|7.45||0.4123|TWO_SIDED|90.0|-6.15|18.371|||Chi-squared|||Week 2||18.371|-6.150|0.4123
70914609|NCT00383188|141320454|SUPERIORITY||Difference in percentage|5.41|STANDARD_ERROR_OF_MEAN|7.29||0.4591|TWO_SIDED|90.0|-6.581|17.392|||Chi-squared|||Week 2||17.392|-6.581|0.4591
70914610|NCT00383188|141320454|SUPERIORITY||Difference in percentage|16.58|STANDARD_ERROR_OF_MEAN|8.93||0.0585|TWO_SIDED|90.0|1.89|31.28|||Chi-squared|||Week 2||31.280|1.890|0.0585
70914611|NCT00383188|141320454|SUPERIORITY||Difference in percentage|15.68|STANDARD_ERROR_OF_MEAN|9.21||0.0808|TWO_SIDED|90.0|0.522|30.829|||Chi-squared|||Week 2||30.829|0.522|0.0808
70914612|NCT00383188|141320454|SUPERIORITY||Difference in percentage|4.86|STANDARD_ERROR_OF_MEAN|7.62||0.524|TWO_SIDED|90.0|-7.684|17.398|||Chi-squared|||Week 4||17.398|-7.684|0.5240
70914613|NCT00383188|141320454|SUPERIORITY||Difference in percentage|14.86|STANDARD_ERROR_OF_MEAN|7.72||0.0571|TWO_SIDED|90.0|2.172|27.588|||Chi-squared|||Week 4||27.588|2.172|0.0571
70914614|NCT00383188|141320454|SUPERIORITY||Difference in percentage|16.15|STANDARD_ERROR_OF_MEAN|9.08||0.0712|TWO_SIDED|90.0|1.222|31.087|||Chi-squared|||Week 4||31.087|1.222|0.0712
70914615|NCT00383188|141320454|SUPERIORITY||Difference in percentage|20.47|STANDARD_ERROR_OF_MEAN|9.43||0.0279|TWO_SIDED|90.0|4.956|35.99|||Chi-squared|||Week 4||35.990|4.956|0.0279
70914616|NCT00383188|141320454|SUPERIORITY||Difference in Percentage|-2.1|STANDARD_ERROR_OF_MEAN|7.67||0.7848|TWO_SIDED|90.0|-14.71|10.515|||Chi-squared|||Week 8||10.515|-14.71|0.7848
70914617|NCT00383188|141320454|SUPERIORITY||Difference in percentage|14.86|STANDARD_ERROR_OF_MEAN|7.91||0.0632|TWO_SIDED|90.0|1.86|27.869|||Chi-squared|||Week 8||27.869|1.860|0.0632
70914618|NCT00383188|141320454|SUPERIORITY||Difference in percentage|9.83|STANDARD_ERROR_OF_MEAN|9.16||0.2783|TWO_SIDED|90.0|-5.237|24.893|||Chi-squared|||Week 8||24.893|-5.237|0.2783
70914619|NCT00383188|141320454|SUPERIORITY||Difference in percentage|16.42|STANDARD_ERROR_OF_MEAN|9.55||0.0828|TWO_SIDED|90.0|0.703|32.135|||Chi-squared|||Week 8||32.135|0.703|0.0828
70914620|NCT00383188|141320454|SUPERIORITY||Difference in percentage|-2.72|STANDARD_ERROR_OF_MEAN|8.54||0.7505|TWO_SIDED|90.0|-16.77|11.328|||Chi-squared|||Week 16||11.328|-16.77|0.7505
70914621|NCT00383188|141320454|SUPERIORITY||Difference in percentage|1.43|STANDARD_ERROR_OF_MEAN|8.35||0.8641|TWO_SIDED|90.0|-12.3|15.156|||Chi-squared|||Week 16||15.156|-12.30|0.8641
70914622|NCT00383188|141320454|SUPERIORITY||Difference in percentage|3.31|STANDARD_ERROR_OF_MEAN|9.99||0.7399|TWO_SIDED|90.0|-13.12|19.734|||Chi-squared|||Week 16||19.734|-13.12|0.7399
70914623|NCT00383188|141320454|SUPERIORITY||Difference in percentage|-12.48|STANDARD_ERROR_OF_MEAN|9.42||0.1996|TWO_SIDED|90.0|-27.98|3.018|||Chi-squared|||Week 16||3.018|-27.98|0.1996
70914624|NCT00383188|141320455|SUPERIORITY||Difference in percentage|1.49|STANDARD_ERROR_OF_MEAN|1.48||0.2982|TWO_SIDED|90.0|-0.944|3.929|||Chi-squared|||Week 1||3.929|-0.944|0.2982
70914625|NCT00383188|141320455|SUPERIORITY||Difference in percentage|1.41|STANDARD_ERROR_OF_MEAN|1.4||0.3122|TWO_SIDED|90.0|-0.892|3.709|||Chi-squared|||Week 1||3.709|-0.892|0.3122
70914626|NCT00383188|141320455|SUPERIORITY||Difference in percentage|4.65|STANDARD_ERROR_OF_MEAN|3.21||0.0649|TWO_SIDED|90.0|-0.631|9.934|||Chi-squared|||Week 1||9.934|-0.631|0.0649
70914627|NCT00383188|141320455|SUPERIORITY||Difference in percentage|5.13|STANDARD_ERROR_OF_MEAN|3.53||0.0525|TWO_SIDED|90.0|-0.681|10.938|||Chi-squared|||Week 1||10.938|-0.681|0.0525
70914628|NCT00383188|141320455|SUPERIORITY||Difference in percentage|4.45|STANDARD_ERROR_OF_MEAN|3.12||0.1481|TWO_SIDED|90.0|-0.681|9.573|||Chi-squared|||Week 2||9.573|-0.681|0.1481
70914629|NCT00383188|141320455|SUPERIORITY||Difference in percentage|8.11|STANDARD_ERROR_OF_MEAN|3.66||0.0292|TWO_SIDED|90.0|2.093|14.124|||Chi-squared|||Week 2||14.124|2.093|0.0292
70914630|NCT00383188|141320455|SUPERIORITY||Difference in percentage|10.01|STANDARD_ERROR_OF_MEAN|4.97||0.0167|TWO_SIDED|90.0|1.839|18.186|||Chi-squared|||Week 2||18.186|1.839|0.0167
71092936|NCT01401166|141692408|SUPERIORITY_OR_OTHER||Estimated Proportion|0.911|||||TWO_SIDED|95.0|0.827|0.956|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding CI were determined using logistic regression with factors of previous Herceptin status and treatment.|||0.956|0.827|
70914631|NCT00383188|141320455|SUPERIORITY||Difference in percentage|11.15|STANDARD_ERROR_OF_MEAN|5.4||0.011|TWO_SIDED|90.0|2.269|20.029|||Chi-squared|||Week 2||20.029|2.269|0.0110
70914632|NCT00383188|141320455|SUPERIORITY||Difference in percentage|-2.51|STANDARD_ERROR_OF_MEAN|3.31||0.455|TWO_SIDED|90.0|-7.959|2.946|||Chi-squared|||Week 4||2.946|-7.959|0.4550
70914633|NCT00383188|141320455|SUPERIORITY||Difference in percentage|8.11|STANDARD_ERROR_OF_MEAN|4.76||0.0919|TWO_SIDED|90.0|0.271|15.946|||Chi-squared|||Week 4||15.946|0.271|0.0919
70914634|NCT00383188|141320455|SUPERIORITY||Difference in percentage|12.78|STANDARD_ERROR_OF_MEAN|6.38||0.0264|TWO_SIDED|90.0|2.28|23.272|||Chi-squared|||Week 4||23.272|2.280|0.0264
70914635|NCT00383188|141320455|SUPERIORITY||Difference in percentage|12.09|STANDARD_ERROR_OF_MEAN|6.56||0.0369|TWO_SIDED|90.0|1.308|22.881|||Chi-squared|||Week 4||22.881|1.308|0.0369
70914636|NCT00383188|141320455|SUPERIORITY||Difference in percentage|-9.17|STANDARD_ERROR_OF_MEAN|4.67||0.0568|TWO_SIDED|90.0|-16.85|-1.482|||Chi-squared|||Week 8||-1.482|-16.85|0.0568
70914637|NCT00383188|141320455|SUPERIORITY||Difference in percentage|4.05|STANDARD_ERROR_OF_MEAN|5.95||0.4961|TWO_SIDED|90.0|-5.727|13.835|||Chi-squared|||Week 8||13.835|-5.727|0.4961
70914638|NCT00383188|141320455|SUPERIORITY||Difference in percentage|6.94|STANDARD_ERROR_OF_MEAN|7.26||0.3212|TWO_SIDED|90.0|-5.008|18.89|||Chi-squared|||Week 8||18.890|-5.008|0.3212
70914639|NCT00383188|141320455|SUPERIORITY||Difference in percentage|1.49|STANDARD_ERROR_OF_MEAN|6.9||0.8274|TWO_SIDED|90.0|-9.87|12.843|||Chi-squared|||Week 8||12.843|-9.870|0.8274
70914640|NCT00383188|141320455|SUPERIORITY||Difference in percentage|5.23|STANDARD_ERROR_OF_MEAN|5.94||0.3774|TWO_SIDED|90.0|-4.538|14.996|||Chi-squared|||Week 12||14.996|-4.538|0.3774
70914641|NCT00383188|141320455|SUPERIORITY||Difference in percentage|9.46|STANDARD_ERROR_OF_MEAN|6.11||0.1246|TWO_SIDED|90.0|-0.591|19.51|||Chi-squared|||Week 12||19.510|-0.591|0.1246
70914642|NCT00383188|141320455|SUPERIORITY||Difference in percentage|8.29|STANDARD_ERROR_OF_MEAN|7.17||0.2257|TWO_SIDED|90.0|-3.502|20.087|||Chi-squared|||Week 12||20.087|-3.502|0.2257
70914643|NCT00383188|141320455|SUPERIORITY||Difference in percentage|5.34|STANDARD_ERROR_OF_MEAN|7.11||0.4336|TWO_SIDED|90.0|-6.355|17.03|||Chi-squared|||Week 12||17.030|-6.355|0.4336
70914644|NCT00383188|141320455|SUPERIORITY||Difference in percentage|-2.07|STANDARD_ERROR_OF_MEAN|7.02||0.7682|TWO_SIDED|90.0|-13.61|9.467|||Chi-squared|||Week 16||9.467|-13.61|0.7682
70914645|NCT00383188|141320455|SUPERIORITY||Difference in percentage|-2.86|STANDARD_ERROR_OF_MEAN|6.76||0.6726|TWO_SIDED|90.0|-13.97|8.257|||Chi-squared|||Week 16||8.257|-13.97|0.6726
70914646|NCT00383188|141320455|SUPERIORITY||Difference in percentage|-5.64|STANDARD_ERROR_OF_MEAN|7.68||0.4795|TWO_SIDED|90.0|-18.28|7.0|||Chi-squared|||Week 16||7.000|-18.28|0.4795
70914647|NCT00383188|141320455|SUPERIORITY||Difference in percentage|-16.17|STANDARD_ERROR_OF_MEAN|6.1||0.0276|TWO_SIDED|90.0|-26.19|-6.137|||Chi-squared|||Week 16||-6.137|-26.19|0.0276
70914648|NCT00383188|141320456|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|0.0||0|TWO_SIDED|90.0|0.0|0.0|||Chi-squared|||Week 1||0.00|0.00|0.000
70914649|NCT00383188|141320456|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|0.0||0|TWO_SIDED|90.0|0.0|0.0|||Chi-squared|||Week 1||0.00|0.00|0.000
70914650|NCT00383188|141320456|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|0.0||0|TWO_SIDED|90.0|0.0|0.0|||Chi-squared|||Week 1||0.00|0.00|0.000
70914651|NCT00383188|141320456|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|0.0||0|TWO_SIDED|90.0|0.0|0.0|||Chi-squared|||Week 1||0.00|0.00|0.000
71092937|NCT03483103|141692430|SUPERIORITY||||||<|0.0001||||||One sided P-value is calculated based on the null hypothesis ORR \<= 50.2%|Exact binomial test|||||||<.0001
71153902|NCT00488683|141800059|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.46|||<|0.001||95.0|||||Non-parametric correlation||Values from Group 1, 2 and 3 were combined for this analysis.|Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration at 12 months of age||||<0.001
70914652|NCT00383188|141320456|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|0.0||0|TWO_SIDED|90.0|0.0|0.0|||Chi-squared|||Week 2||0.00|0.00|0.000
70914653|NCT00383188|141320456|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|0.0||0|TWO_SIDED|90.0|0.0|0.0|||Chi-squared|||Week 2||0.00|0.00|0.000
70914654|NCT00383188|141320456|SUPERIORITY||Difference in percentage|2.27|STANDARD_ERROR_OF_MEAN|2.25||0.1928|TWO_SIDED|90.0|-1.423|5.968|||Chi-squared|||Week 2||5.968|-1.423|0.1928
70914655|NCT00383188|141320456|SUPERIORITY||Difference in percentage|2.5|STANDARD_ERROR_OF_MEAN|2.47||0.1719|TWO_SIDED|90.0|-1.56|6.56|||Chi-squared|||Week 2||6.560|-1.560|0.1719
70914656|NCT00383188|141320456|SUPERIORITY||Difference in percentage|0.1|STANDARD_ERROR_OF_MEAN|1.97||0.9603|TWO_SIDED|90.0|-3.138|3.334|||Chi-squared|||Week 4||3.334|-3.138|0.9603
70914657|NCT00383188|141320456|SUPERIORITY||Difference in percentage|-1.35|STANDARD_ERROR_OF_MEAN|1.34||0.3157|TWO_SIDED|90.0|-3.559|0.856|||Chi-squared|||Week 4||0.856|-3.559|0.3157
70914658|NCT00383188|141320456|SUPERIORITY||Difference in percentage|5.47|STANDARD_ERROR_OF_MEAN|4.03||0.1125|TWO_SIDED|90.0|-1.162|12.096|||Chi-squared|||Week 4||12.096|-1.162|0.1125
70914659|NCT00383188|141320456|SUPERIORITY||Difference in percentage|3.65|STANDARD_ERROR_OF_MEAN|3.7||0.2455|TWO_SIDED|90.0|-2.434|9.732|||Chi-squared|||Week 4||9.732|-2.434|0.2455
70914660|NCT00383188|141320456|SUPERIORITY||Difference in percentage|-2.6|STANDARD_ERROR_OF_MEAN|2.71||0.3452|TWO_SIDED|90.0|-7.057|1.847|||Chi-squared|||Week 8||1.847|-7.057|0.3452
70914661|NCT00383188|141320456|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|3.24||1|TWO_SIDED|90.0|-5.333|5.333|||Chi-squared|||Week 8||5.333|-5.333|1.0000
70914662|NCT00383188|141320456|SUPERIORITY||Difference in percentage|7.31|STANDARD_ERROR_OF_MEAN|5.31||0.1267|TWO_SIDED|90.0|-1.417|16.036|||Chi-squared|||Week 8||16.036|-1.417|0.1267
70914663|NCT00383188|141320456|SUPERIORITY||Difference in percentage|5.95|STANDARD_ERROR_OF_MEAN|5.27||0.2069|TWO_SIDED|90.0|-2.72|14.612|||Chi-squared|||Week 8||14.612|-2.720|0.2069
70914664|NCT00383188|141320456|SUPERIORITY||Difference in percentage|1.84|STANDARD_ERROR_OF_MEAN|4.08||0.6506|TWO_SIDED|90.0|-4.871|8.553|||Chi-squared|||Week 12||8.553|-4.871|0.6506
70914665|NCT00383188|141320456|SUPERIORITY||Difference in percentage|2.7|STANDARD_ERROR_OF_MEAN|4.12||0.5125|TWO_SIDED|90.0|-4.075|9.48|||Chi-squared|||Week 12||9.480|-4.075|0.5125
70914666|NCT00383188|141320456|SUPERIORITY||Difference in percentage|3.69|STANDARD_ERROR_OF_MEAN|5.07||0.4412|TWO_SIDED|90.0|-4.652|12.023|||Chi-squared|||Week 12||12.023|-4.652|0.4412
70914667|NCT00383188|141320456|SUPERIORITY||Difference in percentage|2.09|STANDARD_ERROR_OF_MEAN|4.92||0.6566|TWO_SIDED|90.0|-6.006|10.195|||Chi-squared|||Week 12||10.195|-6.006|0.6566
70914668|NCT00383188|141320456|SUPERIORITY||Difference in percentage|-5.16|STANDARD_ERROR_OF_MEAN|4.5||0.2634|TWO_SIDED|90.0|-12.57|2.247|||Chi-squared|||Week 16||2.247|-12.57|0.2634
70914669|NCT00383188|141320456|SUPERIORITY||Difference in percentage|-2.86|STANDARD_ERROR_OF_MEAN|4.73||0.546|TWO_SIDED|90.0|-10.63|4.916|||Chi-squared|||Week 16||4.916|-10.63|0.5460
70914670|NCT00383188|141320456|SUPERIORITY||Difference in percentage|-7.37|STANDARD_ERROR_OF_MEAN|4.43||0.1626|TWO_SIDED|90.0|-14.65|-0.086|||Chi-squared|||Week 16||-0.086|-14.65|0.1626
70914671|NCT00383188|141320456|SUPERIORITY||Difference in percentage|-7.37|STANDARD_ERROR_OF_MEAN|4.43||0.1626|TWO_SIDED|90.0|-14.65|-0.086|||Chi-squared|||Week 16||-0.086|-14.65|0.1626
70914672|NCT00383188|141320457|SUPERIORITY||Least Square Mean (LSM) Difference|-0.388|STANDARD_ERROR_OF_MEAN|1.025||0.7053|TWO_SIDED|95.0|-2.4|1.624|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.624|-2.400|0.7053
70914673|NCT00383188|141320457|SUPERIORITY||LSM Difference|-1.312|STANDARD_ERROR_OF_MEAN|1.009||0.1938|TWO_SIDED|95.0|-3.291|0.668|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.668|-3.291|0.1938
70914674|NCT00383188|141320457|SUPERIORITY||LSM Difference|-2.187|STANDARD_ERROR_OF_MEAN|1.174||0.0627|TWO_SIDED|95.0|-4.491|0.116|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.116|-4.491|0.0627
70914675|NCT00383188|141320457|SUPERIORITY||LSM Difference|-0.851|STANDARD_ERROR_OF_MEAN|1.206||0.4809|TWO_SIDED|95.0|-3.218|1.517|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.517|-3.218|0.4809
70914676|NCT00383188|141320457|SUPERIORITY||LSM Difference|-1.289|STANDARD_ERROR_OF_MEAN|1.017||0.2057|TWO_SIDED|95.0|-3.286|0.709|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.709|-3.286|0.2057
70914677|NCT00383188|141320457|SUPERIORITY||LSM Difference|-1.331|STANDARD_ERROR_OF_MEAN|0.999||0.1833|TWO_SIDED|95.0|-3.293|0.631|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.631|-3.293|0.1833
70914678|NCT00383188|141320457|SUPERIORITY||LSM Difference|-2.748|STANDARD_ERROR_OF_MEAN|1.166||0.0187|TWO_SIDED|95.0|-5.037|-0.459|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||-0.459|-5.037|0.0187
71153903|NCT00488683|141800059|SUPERIORITY_OR_OTHER||R-square|0.11|||<|0.001||95.0|||||Regression, Linear||Values from Group 1, 2 and 3 were combined for this analysis.|Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration at 12 months of age||||<0.001
70914679|NCT00383188|141320457|SUPERIORITY||LSM Difference|-1.345|STANDARD_ERROR_OF_MEAN|1.197||0.2615|TWO_SIDED|95.0|-3.695|1.005|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.005|-3.695|0.2615
70914680|NCT00383188|141320457|SUPERIORITY||LSM Difference|-1.764|STANDARD_ERROR_OF_MEAN|1.017||0.0832|TWO_SIDED|95.0|-3.761|0.233|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.233|-3.761|0.0832
70914681|NCT00383188|141320457|SUPERIORITY||LSM Difference|-1.615|STANDARD_ERROR_OF_MEAN|0.999||0.1066|TWO_SIDED|95.0|-3.576|0.347|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.347|-3.576|0.1066
70914682|NCT00383188|141320457|SUPERIORITY||LSM Difference|-2.406|STANDARD_ERROR_OF_MEAN|1.166||0.0394|TWO_SIDED|95.0|-4.695|-0.118|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||-0.118|-4.695|0.0394
70914683|NCT00383188|141320457|SUPERIORITY||LSM Difference|-1.355|STANDARD_ERROR_OF_MEAN|1.197||0.258|TWO_SIDED|95.0|-3.705|0.995|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.995|-3.705|0.2580
70914684|NCT00383188|141320457|SUPERIORITY||LSM Difference|-0.758|STANDARD_ERROR_OF_MEAN|1.017||0.456|TWO_SIDED|95.0|-2.754|1.238|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.238|-2.754|0.4560
70914685|NCT00383188|141320457|SUPERIORITY||LSM Difference|-2.021|STANDARD_ERROR_OF_MEAN|0.999||0.0434|TWO_SIDED|95.0|-3.982|-0.06|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||-0.060|-3.982|0.0434
70914686|NCT00383188|141320457|SUPERIORITY||LSM Difference|-1.728|STANDARD_ERROR_OF_MEAN|1.165||0.1386|TWO_SIDED|95.0|-4.016|0.56|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.560|-4.016|0.1386
70914687|NCT00383188|141320457|SUPERIORITY||LSM Difference|-1.154|STANDARD_ERROR_OF_MEAN|1.197||0.3353|TWO_SIDED|95.0|-3.503|1.196|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.196|-3.503|0.3353
70914688|NCT00383188|141320457|SUPERIORITY||LSM Difference|-2.08|STANDARD_ERROR_OF_MEAN|1.016||0.041|TWO_SIDED|95.0|-4.075|-0.085|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||-0.085|-4.075|0.0410
70914689|NCT00383188|141320457|SUPERIORITY||LSM Difference|-2.234|STANDARD_ERROR_OF_MEAN|0.998||0.0255|TWO_SIDED|95.0|-4.194|-0.274|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||-0.274|-4.194|0.0255
71092938|NCT02239328|141692467|OTHER|Multilevel random coefficient models estimated the mean score of each PROMIS domain as a function of time elapsed between date of surgery and assessment (in years), and patient comorbidity. Statistical significance of estimated fixed effects were assessed by the F-test statistic for type 3 tests, p \< 0.05.|||||<|0.05|||||||ANOVA|||||||<0.05
70914690|NCT00383188|141320457|SUPERIORITY||LSM Difference|-2.384|STANDARD_ERROR_OF_MEAN|1.165||0.041|TWO_SIDED|95.0|-4.671|-0.097|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||-0.097|-4.671|0.0410
70914691|NCT00383188|141320457|SUPERIORITY||LSM Difference|-1.911|STANDARD_ERROR_OF_MEAN|1.196||0.1106|TWO_SIDED|95.0|-4.259|0.438|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.438|-4.259|0.1106
70914692|NCT00383188|141320457|SUPERIORITY||LSM Difference|-0.251|STANDARD_ERROR_OF_MEAN|1.048||0.8107|TWO_SIDED|95.0|-2.307|1.805|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.805|-2.307|0.8107
70914693|NCT00383188|141320457|SUPERIORITY||LSM Difference|0.272|STANDARD_ERROR_OF_MEAN|1.017||0.7895|TWO_SIDED|95.0|-1.726|2.269|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||2.269|-1.726|0.7895
70970693|NCT00531752|141447063|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1263|STANDARD_ERROR_OF_MEAN|0.1866||0.5016|TWO_SIDED|80.0|-0.3687|0.11608|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.11608|-0.3687|0.5016
71092939|NCT03881371|141692486|SUPERIORITY||Least-Square Mean|-1.1|STANDARD_ERROR_OF_MEAN|0.277|<|0.0001|TWO_SIDED|95.0|-1.643|-0.555||"Analysis was based on a covariance model (ANCOVA) with treatment and centre as independent factors, baseline mean total daily OFF time measurement as covariate and change from baseline as dependent variable."|ANCOVA|||Treatment difference (Safinamide - Placebo)||-0.555|-1.643|<.0001
70914694|NCT00383188|141320457|SUPERIORITY||LSM Difference|-0.306|STANDARD_ERROR_OF_MEAN|1.206||0.7996|TWO_SIDED|95.0|-2.673|2.06|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||2.060|-2.673|0.7996
70914695|NCT00383188|141320457|SUPERIORITY||LSM Difference|0.185|STANDARD_ERROR_OF_MEAN|1.235||0.8811|TWO_SIDED|95.0|-2.24|2.61|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||2.610|-2.240|0.8811
70914696|NCT00383188|141320458|SUPERIORITY||LSM Difference|-0.687|STANDARD_ERROR_OF_MEAN|0.886||0.4385|TWO_SIDED|95.0|-2.427|1.053|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.053|-2.427|0.4385
70914697|NCT00383188|141320458|SUPERIORITY||LSM Difference|-1.085|STANDARD_ERROR_OF_MEAN|0.87||0.2131|TWO_SIDED|95.0|-2.794|0.624|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.624|-2.794|0.2131
70914698|NCT00383188|141320458|SUPERIORITY||LSM Difference|-1.57|STANDARD_ERROR_OF_MEAN|1.013||0.1216|TWO_SIDED|95.0|-3.559|0.419|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.419|-3.559|0.1216
70914699|NCT00383188|141320458|SUPERIORITY||LSM Difference|-0.675|STANDARD_ERROR_OF_MEAN|1.046||0.519|TWO_SIDED|95.0|-2.728|1.378|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.378|-2.728|0.5190
70914700|NCT00383188|141320458|SUPERIORITY||LSM Difference|-1.464|STANDARD_ERROR_OF_MEAN|0.88||0.0967|TWO_SIDED|95.0|-3.193|0.264|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.264|-3.193|0.0967
71153904|NCT00488683|141800059|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.24||||0.06||95.0|||||Parametric correlation|||Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination||||0.06
70914701|NCT00383188|141320458|SUPERIORITY||LSM Difference|-1.027|STANDARD_ERROR_OF_MEAN|0.863||0.2346|TWO_SIDED|95.0|-2.721|0.668|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.668|-2.721|0.2346
70914702|NCT00383188|141320458|SUPERIORITY||LSM Difference|-1.658|STANDARD_ERROR_OF_MEAN|1.007||0.1|TWO_SIDED|95.0|-3.635|0.318|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.318|-3.635|0.1000
70914703|NCT00383188|141320458|SUPERIORITY||LSM Difference|-0.805|STANDARD_ERROR_OF_MEAN|1.038||0.4385|TWO_SIDED|95.0|-2.844|1.234|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||1.234|-2.844|0.4385
70914704|NCT00383188|141320458|SUPERIORITY||LSM Difference|-1.599|STANDARD_ERROR_OF_MEAN|0.88||0.0696|TWO_SIDED|95.0|-3.327|0.128|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.128|-3.327|0.0696
70914705|NCT00383188|141320458|SUPERIORITY||LSM Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.863||0.0642|TWO_SIDED|95.0|-3.294|0.094|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.094|-3.294|0.0642
70914706|NCT00383188|141320458|SUPERIORITY||LSM Difference|-1.83|STANDARD_ERROR_OF_MEAN|1.007||0.0695|TWO_SIDED|95.0|-3.807|0.146|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.146|-3.807|0.0695
70914707|NCT00383188|141320458|SUPERIORITY||LSM Difference|-0.493|STANDARD_ERROR_OF_MEAN|1.038||0.6349|TWO_SIDED|95.0|-2.532|1.545|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||1.545|-2.532|0.6349
70914708|NCT00383188|141320458|SUPERIORITY||LSM Difference|-1.176|STANDARD_ERROR_OF_MEAN|0.88||0.1818|TWO_SIDED|95.0|-2.903|0.551|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.551|-2.903|0.1818
70914709|NCT00383188|141320458|SUPERIORITY||LSM Difference|-1.268|STANDARD_ERROR_OF_MEAN|0.862||0.1421|TWO_SIDED|95.0|-2.961|0.426|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.426|-2.961|0.1421
71153905|NCT00488683|141800059|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.5|||<|0.001||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination||||<0.001
70914710|NCT00383188|141320458|SUPERIORITY||LSM Difference|-0.898|STANDARD_ERROR_OF_MEAN|1.006||0.3726|TWO_SIDED|95.0|-2.874|1.078|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||1.078|-2.874|0.3726
70914711|NCT00383188|141320458|SUPERIORITY||LSM Difference|-0.701|STANDARD_ERROR_OF_MEAN|1.038||0.4995|TWO_SIDED|95.0|-2.739|1.337|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||1.337|-2.739|0.4995
70914712|NCT00383188|141320458|SUPERIORITY||LSM Difference|-1.601|STANDARD_ERROR_OF_MEAN|0.879||0.0691|TWO_SIDED|95.0|-3.327|0.126|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.126|-3.327|0.0691
70914713|NCT00383188|141320458|SUPERIORITY||LSM Difference|-1.086|STANDARD_ERROR_OF_MEAN|0.862||0.2083|TWO_SIDED|95.0|-2.778|0.607|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.607|-2.778|0.2083
70914714|NCT00383188|141320458|SUPERIORITY||LSM Difference|-0.836|STANDARD_ERROR_OF_MEAN|1.006||0.4063|TWO_SIDED|95.0|-2.811|1.139|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||1.139|-2.811|0.4063
70914715|NCT00383188|141320458|SUPERIORITY||LSM Difference|-0.196|STANDARD_ERROR_OF_MEAN|1.038||0.8501|TWO_SIDED|95.0|-2.234|1.841|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||1.841|-2.234|0.8501
70914716|NCT00383188|141320458|SUPERIORITY||LSM Difference|0.376|STANDARD_ERROR_OF_MEAN|0.904||0.6778|TWO_SIDED|95.0|-1.399|2.15|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||2.150|-1.399|0.6778
70914717|NCT00383188|141320458|SUPERIORITY||LSM Difference|0.508|STANDARD_ERROR_OF_MEAN|0.877||0.5627|TWO_SIDED|95.0|-1.214|2.23|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||2.230|-1.214|0.5627
70914718|NCT00383188|141320458|SUPERIORITY||LSM Difference|0.537|STANDARD_ERROR_OF_MEAN|1.038||0.6049|TWO_SIDED|95.0|-1.501|2.576|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||2.576|-1.501|0.6049
70914719|NCT00383188|141320458|SUPERIORITY||LSM Difference|0.51|STANDARD_ERROR_OF_MEAN|1.068||0.6332|TWO_SIDED|95.0|-1.587|2.608|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||2.608|-1.587|0.6332
70914720|NCT00383188|141320459|SUPERIORITY||LSM Difference|-2.802|STANDARD_ERROR_OF_MEAN|4.098||0.4943|TWO_SIDED|95.0|-10.85|5.243|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||5.243|-10.85|0.4943
70914721|NCT00383188|141320459|SUPERIORITY||LSM Difference|-10.19|STANDARD_ERROR_OF_MEAN|4.026||0.0116|TWO_SIDED|95.0|-18.09|-2.283|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-2.283|-18.09|0.0116
71092940|NCT03881371|141692487|SUPERIORITY||Least-Square Mean|-0.03|STANDARD_ERROR_OF_MEAN|0.21||0.8901|TWO_SIDED|95.0|-0.44|0.382||ANCOVA with treatment and centre as independent factors, baseline NRS measurement as covariate and change from baseline as dependent variable.|ANCOVA|||Treatment difference (Safinamide - Placebo)||0.382|-0.440|0.8901
70914722|NCT00383188|141320459|SUPERIORITY||LSM Difference|-12.73|STANDARD_ERROR_OF_MEAN|4.71||0.007|TWO_SIDED|95.0|-21.98|-3.485|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-3.485|-21.98|0.0070
70914723|NCT00383188|141320459|SUPERIORITY||LSM Difference|-11.14|STANDARD_ERROR_OF_MEAN|4.812||0.0209|TWO_SIDED|95.0|-20.58|-1.688|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-1.688|-20.58|0.0209
70914724|NCT00383188|141320459|SUPERIORITY||LSM Difference|-7.439|STANDARD_ERROR_OF_MEAN|4.056||0.0671|TWO_SIDED|95.0|-15.4|0.524|||ANCOVA|||Week 2:Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||0.524|-15.40|0.0671
70914725|NCT00383188|141320459|SUPERIORITY||LSM Difference|-10.46|STANDARD_ERROR_OF_MEAN|3.986||0.0089|TWO_SIDED|95.0|-18.28|-2.632|||ANCOVA|||Week 2:Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-2.632|-18.28|0.0089
71153906|NCT00488683|141800059|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.31||||0.01||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination||||0.01
70914726|NCT00383188|141320459|SUPERIORITY||LSM Difference|-14.1|STANDARD_ERROR_OF_MEAN|4.657||0.0025|TWO_SIDED|95.0|-23.24|-4.959|||ANCOVA|||Week 2:Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-4.959|-23.24|0.0025
70914727|NCT00383188|141320459|SUPERIORITY||LSM Difference|-7.876|STANDARD_ERROR_OF_MEAN|4.774||0.0994|TWO_SIDED|95.0|-17.25|1.496|||ANCOVA|||Week 2:Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||1.496|-17.25|0.0994
70914728|NCT00383188|141320459|SUPERIORITY||LSM Difference|-1.964|STANDARD_ERROR_OF_MEAN|4.056||0.6284|TWO_SIDED|95.0|-9.926|5.999|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||5.999|-9.926|0.6284
70914729|NCT00383188|141320459|SUPERIORITY||LSM Difference|-9.934|STANDARD_ERROR_OF_MEAN|3.986||0.0129|TWO_SIDED|95.0|-17.76|-2.109|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-2.109|-17.76|0.0129
70914730|NCT00383188|141320459|SUPERIORITY||LSM Difference|-8.097|STANDARD_ERROR_OF_MEAN|4.656||0.0825|TWO_SIDED|95.0|-17.24|1.044|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||1.044|-17.24|0.0825
70914731|NCT00383188|141320459|SUPERIORITY||LSM Difference|-1.907|STANDARD_ERROR_OF_MEAN|4.774||0.6897|TWO_SIDED|95.0|-11.28|7.465|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||7.465|-11.28|0.6897
70914732|NCT00383188|141320459|SUPERIORITY||LSM Difference|1.861|STANDARD_ERROR_OF_MEAN|4.055||0.6465|TWO_SIDED|95.0|-6.1|9.821|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||9.821|-6.100|0.6465
70914733|NCT00383188|141320459|SUPERIORITY||LSM Difference|-10.65|STANDARD_ERROR_OF_MEAN|3.985||0.0077|TWO_SIDED|95.0|-18.47|-2.824|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-2.824|-18.47|0.0077
70914734|NCT00383188|141320459|SUPERIORITY||LSM Difference|-7.927|STANDARD_ERROR_OF_MEAN|4.655||0.089|TWO_SIDED|95.0|-17.07|1.213|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||1.213|-17.07|0.0890
70914735|NCT00383188|141320459|SUPERIORITY||LSM Difference|-5.964|STANDARD_ERROR_OF_MEAN|4.773||0.2119|TWO_SIDED|95.0|-15.33|3.406|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||3.406|-15.33|0.2119
70914736|NCT00383188|141320459|SUPERIORITY||LSM Difference|-4.766|STANDARD_ERROR_OF_MEAN|4.053||0.2401|TWO_SIDED|95.0|-12.72|3.191|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||3.191|-12.72|0.2401
70914737|NCT00383188|141320459|SUPERIORITY||LSM Difference|-11.07|STANDARD_ERROR_OF_MEAN|3.983||0.0056|TWO_SIDED|95.0|-18.89|-3.251|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-3.251|-18.89|0.0056
70914738|NCT00383188|141320459|SUPERIORITY||LSM Difference|-8.885|STANDARD_ERROR_OF_MEAN|4.654||0.0566|TWO_SIDED|95.0|-18.02|0.251|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||0.251|-18.02|0.0566
70970694|NCT00531752|141447063|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3451|STANDARD_ERROR_OF_MEAN|0.1738||0.0531|TWO_SIDED|80.0|-0.5711|-0.1191|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.1191|-0.5711|0.0531
71092941|NCT03881371|141692488|SUPERIORITY||Least-Square Mean|0.89|STANDARD_ERROR_OF_MEAN|0.315||0.0049|TWO_SIDED|95.0|0.274|1.515||"ANCOVA with treatment and centre as independent factors, baseline mean total daily ON time measurement as covariate and change from baseline as dependent variable."|ANCOVA|||Treatment difference (Safinamide - Placebo)||1.515|0.274|0.0049
70914739|NCT00383188|141320459|SUPERIORITY||LSM Difference|-10.09|STANDARD_ERROR_OF_MEAN|4.772||0.0348|TWO_SIDED|95.0|-19.45|-0.72|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-0.720|-19.45|0.0348
70914740|NCT00383188|141320459|SUPERIORITY||LSM Difference|4.89|STANDARD_ERROR_OF_MEAN|4.191||0.2436|TWO_SIDED|95.0|-3.336|13.116|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||13.116|-3.336|0.2436
70914741|NCT00383188|141320459|SUPERIORITY||LSM Difference|-1.781|STANDARD_ERROR_OF_MEAN|4.066||0.6616|TWO_SIDED|95.0|-9.762|6.201|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||6.201|-9.762|0.6616
70914742|NCT00383188|141320459|SUPERIORITY||LSM Difference|3.907|STANDARD_ERROR_OF_MEAN|4.83||0.4189|TWO_SIDED|95.0|-5.574|13.388|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||13.388|-5.574|0.4189
70914743|NCT00383188|141320459|SUPERIORITY||LSM Difference|4.395|STANDARD_ERROR_OF_MEAN|4.942||0.3741|TWO_SIDED|95.0|-5.305|14.096|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||14.096|-5.305|0.3741
70914744|NCT00383188|141320460|SUPERIORITY||LSM Difference|-2.996|STANDARD_ERROR_OF_MEAN|3.958||0.4493|TWO_SIDED|95.0|-10.77|4.773|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||4.773|-10.77|0.4493
70914745|NCT00383188|141320460|SUPERIORITY||LSM Difference|-14.45|STANDARD_ERROR_OF_MEAN|3.891||0.0002|TWO_SIDED|95.0|-22.08|-6.807|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-6.807|-22.08|0.0002
70914746|NCT00383188|141320460|SUPERIORITY||LSM Difference|-11.54|STANDARD_ERROR_OF_MEAN|4.522||0.0109|TWO_SIDED|95.0|-20.42|-2.661|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-2.661|-20.42|0.0109
70914747|NCT00383188|141320460|SUPERIORITY||LSM Difference|-7.364|STANDARD_ERROR_OF_MEAN|4.651||0.1137|TWO_SIDED|95.0|-16.49|1.765|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||1.765|-16.49|0.1137
70914748|NCT00383188|141320460|SUPERIORITY||LSM Difference|-3.989|STANDARD_ERROR_OF_MEAN|3.915||0.3086|TWO_SIDED|95.0|-11.68|3.697|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||3.697|-11.68|0.3086
70914749|NCT00383188|141320460|SUPERIORITY||LSM Difference|-8.357|STANDARD_ERROR_OF_MEAN|3.85||0.0303|TWO_SIDED|95.0|-15.92|-0.799|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-0.799|-15.92|0.0303
70914750|NCT00383188|141320460|SUPERIORITY||LSM Difference|-10.66|STANDARD_ERROR_OF_MEAN|4.489||0.0178|TWO_SIDED|95.0|-19.47|-1.845|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-1.845|-19.47|0.0178
70914751|NCT00383188|141320460|SUPERIORITY||LSM Difference|-5.325|STANDARD_ERROR_OF_MEAN|4.612||0.2486|TWO_SIDED|95.0|-14.38|3.729|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||3.729|-14.38|0.2486
70914752|NCT00383188|141320460|SUPERIORITY||LSM Difference|-2.965|STANDARD_ERROR_OF_MEAN|3.915||0.4491|TWO_SIDED|95.0|-10.65|4.72|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||4.720|-10.65|0.4491
70914753|NCT00383188|141320460|SUPERIORITY||LSM Difference|-10.23|STANDARD_ERROR_OF_MEAN|3.85||0.0081|TWO_SIDED|95.0|-17.79|-2.671|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-2.671|-17.79|0.0081
70914754|NCT00383188|141320460|SUPERIORITY||LSM Difference|-9.291|STANDARD_ERROR_OF_MEAN|4.488||0.0388|TWO_SIDED|95.0|-18.1|-0.48|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-0.480|-18.10|0.0388
70914755|NCT00383188|141320460|SUPERIORITY||LSM Difference|-2.5|STANDARD_ERROR_OF_MEAN|4.611||0.588|TWO_SIDED|95.0|-11.55|6.553|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||6.553|-11.55|0.5880
70914756|NCT00383188|141320460|SUPERIORITY||LSM Difference|3.78|STANDARD_ERROR_OF_MEAN|3.914||0.3345|TWO_SIDED|95.0|-3.904|11.464|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||11.464|-3.904|0.3345
70970695|NCT00531752|141447063|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4137|STANDARD_ERROR_OF_MEAN|0.1856||0.0306|TWO_SIDED|80.0|-0.6549|-0.1725|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.1725|-0.6549|0.0306
70914757|NCT00383188|141320460|SUPERIORITY||LSM Difference|-9.019|STANDARD_ERROR_OF_MEAN|3.849||0.0194|TWO_SIDED|95.0|-16.58|-1.463|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-1.463|-16.58|0.0194
70914758|NCT00383188|141320460|SUPERIORITY||LSM Difference|-5.946|STANDARD_ERROR_OF_MEAN|4.488||0.1855|TWO_SIDED|95.0|-14.76|2.863|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||2.863|-14.76|0.1855
70914759|NCT00383188|141320460|SUPERIORITY||LSM Difference|-5.249|STANDARD_ERROR_OF_MEAN|4.611||0.2553|TWO_SIDED|95.0|-14.3|3.803|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||3.803|-14.30|0.2553
70914760|NCT00383188|141320460|SUPERIORITY||LSM Difference|-4.041|STANDARD_ERROR_OF_MEAN|3.912||0.302|TWO_SIDED|95.0|-11.72|3.639|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||3.639|-11.72|0.3020
70914761|NCT00383188|141320460|SUPERIORITY||LSM Difference|-10.27|STANDARD_ERROR_OF_MEAN|3.847||0.0078|TWO_SIDED|95.0|-17.82|-2.715|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-2.715|-17.82|0.0078
70914762|NCT00383188|141320460|SUPERIORITY||LSM Difference|-8.522|STANDARD_ERROR_OF_MEAN|4.486||0.0578|TWO_SIDED|95.0|-17.33|0.284|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||0.284|-17.33|0.0578
70914763|NCT00383188|141320460|SUPERIORITY||LSM Difference|-7.042|STANDARD_ERROR_OF_MEAN|4.61||0.127|TWO_SIDED|95.0|-16.09|2.007|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||2.007|-16.09|0.1270
70914764|NCT00383188|141320460|SUPERIORITY||LSM Difference|5.927|STANDARD_ERROR_OF_MEAN|4.051||0.1438|TWO_SIDED|95.0|-2.023|13.877|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||13.877|-2.023|0.1438
70914765|NCT00383188|141320460|SUPERIORITY||LSM Difference|-1.979|STANDARD_ERROR_OF_MEAN|3.931||0.6149|TWO_SIDED|95.0|-9.696|5.738|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||5.738|-9.696|0.6149
70914766|NCT00383188|141320460|SUPERIORITY||LSM Difference|6.545|STANDARD_ERROR_OF_MEAN|4.664||0.1609|TWO_SIDED|95.0|-2.61|15.7|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||15.700|-2.610|0.1609
70914767|NCT00383188|141320460|SUPERIORITY||LSM Difference|6.579|STANDARD_ERROR_OF_MEAN|4.78||0.1691|TWO_SIDED|95.0|-2.804|15.961|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||15.961|-2.804|0.1691
70914768|NCT00383188|141320461|SUPERIORITY||LSM Difference|-1.409|STANDARD_ERROR_OF_MEAN|3.341||0.6733|TWO_SIDED|95.0|-7.967|5.149|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||5.149|-7.967|0.6733
70914769|NCT00383188|141320461|SUPERIORITY||LSM Difference|-5.629|STANDARD_ERROR_OF_MEAN|3.274||0.0859|TWO_SIDED|95.0|-12.05|0.797|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||0.797|-12.05|0.0859
70914770|NCT00383188|141320461|SUPERIORITY||LSM Difference|-9.718|STANDARD_ERROR_OF_MEAN|3.8||0.0107|TWO_SIDED|95.0|-17.18|-2.259|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-2.259|-17.18|0.0107
70914771|NCT00383188|141320461|SUPERIORITY||LSM Difference|-3.695|STANDARD_ERROR_OF_MEAN|3.921||0.3463|TWO_SIDED|95.0|-11.39|4.002|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||4.002|-11.39|0.3463
70914772|NCT00383188|141320461|SUPERIORITY||LSM Difference|-5.185|STANDARD_ERROR_OF_MEAN|3.312||0.1178|TWO_SIDED|95.0|-11.69|1.316|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||1.316|-11.69|0.1178
70970696|NCT00531752|141447064|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7671|STANDARD_ERROR_OF_MEAN|0.1731|<|0.0001|TWO_SIDED|80.0|0.5426|0.99157|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.99157|0.54260|<0.0001
70914773|NCT00383188|141320461|SUPERIORITY||LSM Difference|-7.107|STANDARD_ERROR_OF_MEAN|3.245||0.0288|TWO_SIDED|95.0|-13.48|-0.737|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-0.737|-13.48|0.0288
70914774|NCT00383188|141320461|SUPERIORITY||LSM Difference|-9.743|STANDARD_ERROR_OF_MEAN|3.772||0.01|TWO_SIDED|95.0|-17.15|-2.34|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-2.340|-17.15|0.0100
70914775|NCT00383188|141320461|SUPERIORITY||LSM Difference|-5.468|STANDARD_ERROR_OF_MEAN|3.888||0.16|TWO_SIDED|95.0|-13.1|2.164|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||2.164|-13.10|0.1600
70914776|NCT00383188|141320461|SUPERIORITY||LSM Difference|-0.4|STANDARD_ERROR_OF_MEAN|3.312||0.904|TWO_SIDED|95.0|-6.9|6.101|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||6.101|-6.900|0.9040
70914777|NCT00383188|141320461|SUPERIORITY||LSM Difference|-6.895|STANDARD_ERROR_OF_MEAN|3.245||0.0339|TWO_SIDED|95.0|-13.26|-0.524|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-0.524|-13.26|0.0339
70914778|NCT00383188|141320461|SUPERIORITY||LSM Difference|-8.891|STANDARD_ERROR_OF_MEAN|3.771||0.0186|TWO_SIDED|95.0|-16.29|-1.488|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-1.488|-16.29|0.0186
70914779|NCT00383188|141320461|SUPERIORITY||LSM Difference|-2.714|STANDARD_ERROR_OF_MEAN|3.888||0.4854|TWO_SIDED|95.0|-10.35|4.918|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||4.918|-10.35|0.4854
70914780|NCT00383188|141320461|SUPERIORITY||LSM Difference|-1.387|STANDARD_ERROR_OF_MEAN|3.311||0.6753|TWO_SIDED|95.0|-7.886|5.112|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||5.112|-7.886|0.6753
71092942|NCT03881371|141692489|SUPERIORITY||Least-Square Mean|1.07|STANDARD_ERROR_OF_MEAN|0.345||0.0021|TWO_SIDED|95.0|0.392|1.753||"ANCOVA with treatment and centre as independent factors, baseline mean total daily ON time with no/non-troublesome Dyskinesia measurement as covariate and change from baseline as dependent variable."|ANCOVA|||||1.753|0.392|0.0021
70914781|NCT00383188|141320461|SUPERIORITY||LSM Difference|-11.09|STANDARD_ERROR_OF_MEAN|3.244||0.0007|TWO_SIDED|95.0|-17.46|-4.724|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-4.724|-17.46|0.0007
70914782|NCT00383188|141320461|SUPERIORITY||LSM Difference|-9.535|STANDARD_ERROR_OF_MEAN|3.771||0.0116|TWO_SIDED|95.0|-16.94|-2.134|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-2.134|-16.94|0.0116
70914783|NCT00383188|141320461|SUPERIORITY||LSM Difference|-8.322|STANDARD_ERROR_OF_MEAN|3.888||0.0326|TWO_SIDED|95.0|-15.95|-0.691|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-0.691|-15.95|0.0326
70914784|NCT00383188|141320461|SUPERIORITY||LSM Difference|-3.624|STANDARD_ERROR_OF_MEAN|3.309||0.2738|TWO_SIDED|95.0|-10.12|2.872|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||2.872|-10.12|0.2738
70914785|NCT00383188|141320461|SUPERIORITY||LSM Difference|-9.778|STANDARD_ERROR_OF_MEAN|3.243||0.0026|TWO_SIDED|95.0|-16.14|-3.412|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-3.412|-16.14|0.0026
70914786|NCT00383188|141320461|SUPERIORITY||LSM Difference|-9.339|STANDARD_ERROR_OF_MEAN|3.769||0.0134|TWO_SIDED|95.0|-16.74|-1.941|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-1.941|-16.74|0.0134
70914787|NCT00383188|141320461|SUPERIORITY||LSM Difference|-5.528|STANDARD_ERROR_OF_MEAN|3.886||0.1553|TWO_SIDED|95.0|-13.16|2.101|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||2.101|-13.16|0.1553
71092943|NCT03881371|141692490|SUPERIORITY||Least-Square Mean|-5.99|STANDARD_ERROR_OF_MEAN|1.447|<|0.0001|TWO_SIDED|95.0|-8.842|-3.141||ANCOVA with treatment and centre as independent factors, baseline UPDRS score as covariate and change from baseline as dependent variable.|ANCOVA|||Treatment difference (Safinamide - Placebo)||-3.141|-8.842|<.0001
70914788|NCT00383188|141320461|SUPERIORITY||LSM Difference|-0.118|STANDARD_ERROR_OF_MEAN|3.444||0.9726|TWO_SIDED|95.0|-6.878|6.641|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||6.641|-6.878|0.9726
70914789|NCT00383188|141320461|SUPERIORITY||LSM Difference|1.409|STANDARD_ERROR_OF_MEAN|3.321||0.6714|TWO_SIDED|95.0|-5.109|7.928|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||7.928|-5.109|0.6714
70914790|NCT00383188|141320461|SUPERIORITY||LSM Difference|0.646|STANDARD_ERROR_OF_MEAN|3.925||0.8693|TWO_SIDED|95.0|-7.058|8.351|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||8.351|-7.058|0.8693
70914791|NCT00383188|141320461|SUPERIORITY||LSM Difference|1.289|STANDARD_ERROR_OF_MEAN|4.035||0.7495|TWO_SIDED|95.0|-6.631|9.208|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||9.208|-6.631|0.7495
70914792|NCT00383188|141320462|SUPERIORITY||LSM Difference|-8.983|STANDARD_ERROR_OF_MEAN|4.469||0.0447|TWO_SIDED|95.0|-17.75|-0.214|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||-0.214|-17.75|0.0447
70914793|NCT00383188|141320462|SUPERIORITY||LSM Difference|-15.12|STANDARD_ERROR_OF_MEAN|4.345||0.0005|TWO_SIDED|95.0|-23.65|-6.596|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||-6.596|-23.65|0.0005
70914794|NCT00383188|141320462|SUPERIORITY||LSM Difference|-17.07|STANDARD_ERROR_OF_MEAN|4.981||0.0006|TWO_SIDED|95.0|-26.84|-7.296|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||-7.296|-26.84|0.0006
70914795|NCT00383188|141320462|SUPERIORITY||LSM Difference|-16.26|STANDARD_ERROR_OF_MEAN|5.218||0.0019|TWO_SIDED|95.0|-26.49|-6.018|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||-6.018|-26.49|0.0019
70914796|NCT00383188|141320462|SUPERIORITY||LSM Difference|-3.841|STANDARD_ERROR_OF_MEAN|4.366||0.3792|TWO_SIDED|95.0|-12.41|4.726|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||4.726|-12.41|0.3792
70914797|NCT00383188|141320462|SUPERIORITY||LSM Difference|-9.345|STANDARD_ERROR_OF_MEAN|4.237||0.0276|TWO_SIDED|95.0|-17.66|-1.031|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||-1.031|-17.66|0.0276
70914798|NCT00383188|141320462|SUPERIORITY||LSM Difference|-12.69|STANDARD_ERROR_OF_MEAN|4.873||0.0093|TWO_SIDED|95.0|-22.25|-3.128|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||-3.128|-22.25|0.0093
70914799|NCT00383188|141320462|SUPERIORITY||LSM Difference|-9.599|STANDARD_ERROR_OF_MEAN|5.03||0.0566|TWO_SIDED|95.0|-19.47|0.271|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||0.271|-19.47|0.0566
70914800|NCT00383188|141320462|SUPERIORITY||LSM Difference|0.803|STANDARD_ERROR_OF_MEAN|4.366||0.854|TWO_SIDED|95.0|-7.764|9.37|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||9.370|-7.764|0.8540
70914801|NCT00383188|141320462|SUPERIORITY||LSM Difference|-2.364|STANDARD_ERROR_OF_MEAN|4.237||0.577|TWO_SIDED|95.0|-10.68|5.95|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||5.950|-10.68|0.5770
70914802|NCT00383188|141320462|SUPERIORITY||LSM Difference|-6.33|STANDARD_ERROR_OF_MEAN|4.873||0.1942|TWO_SIDED|95.0|-15.89|3.232|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||3.232|-15.89|0.1942
70914803|NCT00383188|141320462|SUPERIORITY||LSM Difference|1.494|STANDARD_ERROR_OF_MEAN|5.03||0.7665|TWO_SIDED|95.0|-8.376|11.364|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||11.364|-8.376|0.7665
70914804|NCT00383188|141320462|SUPERIORITY||LSM Difference|3.291|STANDARD_ERROR_OF_MEAN|4.366||0.4512|TWO_SIDED|95.0|-5.276|11.858|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||11.858|-5.276|0.4512
70914805|NCT00383188|141320462|SUPERIORITY||LSM Difference|-0.095|STANDARD_ERROR_OF_MEAN|4.237||0.9822|TWO_SIDED|95.0|-8.409|8.22|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||8.220|-8.409|0.9822
70914806|NCT00383188|141320462|SUPERIORITY||LSM Difference|-5.148|STANDARD_ERROR_OF_MEAN|4.873||0.291|TWO_SIDED|95.0|-14.71|4.414|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||4.414|-14.71|0.2910
70914807|NCT00383188|141320462|SUPERIORITY||LSM Difference|2.828|STANDARD_ERROR_OF_MEAN|5.03||0.5741|TWO_SIDED|95.0|-7.042|12.698|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||12.698|-7.042|0.5741
70914808|NCT00383188|141320462|SUPERIORITY||LSM Difference|3.107|STANDARD_ERROR_OF_MEAN|4.366||0.4768|TWO_SIDED|95.0|-5.46|11.674|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||11.674|-5.460|0.4768
70914809|NCT00383188|141320462|SUPERIORITY||LSM Difference|-2.256|STANDARD_ERROR_OF_MEAN|4.237||0.5945|TWO_SIDED|95.0|-10.57|6.058|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||6.058|-10.57|0.5945
70914810|NCT00383188|141320462|SUPERIORITY||LSM Difference|0.609|STANDARD_ERROR_OF_MEAN|4.873||0.9006|TWO_SIDED|95.0|-8.953|10.171|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||10.171|-8.953|0.9006
70914811|NCT00383188|141320462|SUPERIORITY||LSM Difference|9.224|STANDARD_ERROR_OF_MEAN|5.03||0.067|TWO_SIDED|95.0|-0.646|19.094|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||19.094|-0.646|0.0670
70914812|NCT00383188|141320462|SUPERIORITY||LSM Difference|8.261|STANDARD_ERROR_OF_MEAN|4.647||0.0757|TWO_SIDED|95.0|-0.857|17.379|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||17.379|-0.857|0.0757
70914813|NCT00383188|141320462|SUPERIORITY||LSM Difference|5.357|STANDARD_ERROR_OF_MEAN|4.427||0.2265|TWO_SIDED|95.0|-3.329|14.043|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||14.043|-3.329|0.2265
70914814|NCT00383188|141320462|SUPERIORITY||LSM Difference|1.642|STANDARD_ERROR_OF_MEAN|5.178||0.7512|TWO_SIDED|95.0|-8.517|11.801|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||11.801|-8.517|0.7512
70914815|NCT00383188|141320462|SUPERIORITY||LSM Difference|2.888|STANDARD_ERROR_OF_MEAN|5.323||0.5876|TWO_SIDED|95.0|-7.557|13.332|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||13.332|-7.557|0.5876
70914816|NCT00383188|141320463|SUPERIORITY||LSM Difference|-0.269|STANDARD_ERROR_OF_MEAN|0.188||0.154|TWO_SIDED|95.0|-0.638|0.101|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.101|-0.638|0.1540
70914817|NCT00383188|141320463|SUPERIORITY||LSM Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.182||0.0011|TWO_SIDED|95.0|-0.958|-0.242|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.242|-0.958|0.0011
70914818|NCT00383188|141320463|SUPERIORITY||LSM Difference|-0.691|STANDARD_ERROR_OF_MEAN|0.211||0.0011|TWO_SIDED|95.0|-1.105|-0.277|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.277|-1.105|0.0011
70914819|NCT00383188|141320463|SUPERIORITY||LSM Difference|-0.554|STANDARD_ERROR_OF_MEAN|0.219||0.0115|TWO_SIDED|95.0|-0.983|-0.125|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.125|-0.983|0.0115
70914820|NCT00383188|141320463|SUPERIORITY||LSM Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.185||0.094|TWO_SIDED|95.0|-0.673|0.053|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.053|-0.673|0.0940
70914821|NCT00383188|141320463|SUPERIORITY||LSM Difference|-0.459|STANDARD_ERROR_OF_MEAN|0.18||0.0109|TWO_SIDED|95.0|-0.811|-0.106|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.106|-0.811|0.0109
70914822|NCT00383188|141320463|SUPERIORITY||LSM Difference|-0.667|STANDARD_ERROR_OF_MEAN|0.208||0.0014|TWO_SIDED|95.0|-1.075|-0.259|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.259|-1.075|0.0014
70914823|NCT00383188|141320463|SUPERIORITY||LSM Difference|-0.447|STANDARD_ERROR_OF_MEAN|0.213||0.0364|TWO_SIDED|95.0|-0.867|-0.028|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.028|-0.867|0.0364
70914824|NCT00383188|141320463|SUPERIORITY||LSM Difference|-0.271|STANDARD_ERROR_OF_MEAN|0.185||0.1436|TWO_SIDED|95.0|-0.634|0.092|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.092|-0.634|0.1436
70914825|NCT00383188|141320463|SUPERIORITY||LSM Difference|-0.404|STANDARD_ERROR_OF_MEAN|0.18||0.0246|TWO_SIDED|95.0|-0.757|-0.052|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.052|-0.757|0.0246
70914826|NCT00383188|141320463|SUPERIORITY||LSM Difference|-0.546|STANDARD_ERROR_OF_MEAN|0.208||0.0088|TWO_SIDED|95.0|-0.954|-0.138|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.138|-0.954|0.0088
70914827|NCT00383188|141320463|SUPERIORITY||LSM Difference|-0.267|STANDARD_ERROR_OF_MEAN|0.213||0.2121|TWO_SIDED|95.0|-0.686|0.152|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.152|-0.686|0.2121
70914828|NCT00383188|141320463|SUPERIORITY||LSM Difference|-0.098|STANDARD_ERROR_OF_MEAN|0.185||0.5975|TWO_SIDED|95.0|-0.461|0.265|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.265|-0.461|0.5975
70914829|NCT00383188|141320463|SUPERIORITY||LSM Difference|-0.464|STANDARD_ERROR_OF_MEAN|0.18||0.0099|TWO_SIDED|95.0|-0.817|-0.112|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.112|-0.817|0.0099
70914830|NCT00383188|141320463|SUPERIORITY||LSM Difference|-0.445|STANDARD_ERROR_OF_MEAN|0.208||0.0328|TWO_SIDED|95.0|-0.853|-0.037|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.037|-0.853|0.0328
70914831|NCT00383188|141320463|SUPERIORITY||LSM Difference|-0.214|STANDARD_ERROR_OF_MEAN|0.213||0.3162|TWO_SIDED|95.0|-0.633|0.205|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.205|-0.633|0.3162
70914832|NCT00383188|141320463|SUPERIORITY||LSM Difference|-0.353|STANDARD_ERROR_OF_MEAN|0.185||0.0569|TWO_SIDED|95.0|-0.716|0.01|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.010|-0.716|0.0569
70914833|NCT00383188|141320463|SUPERIORITY||LSM Difference|-0.449|STANDARD_ERROR_OF_MEAN|0.18||0.0126|TWO_SIDED|95.0|-0.801|-0.096|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.096|-0.801|0.0126
70914834|NCT00383188|141320463|SUPERIORITY||LSM Difference|-0.515|STANDARD_ERROR_OF_MEAN|0.208||0.0135|TWO_SIDED|95.0|-0.923|-0.107|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.107|-0.923|0.0135
70914835|NCT00383188|141320463|SUPERIORITY||LSM Difference|-0.145|STANDARD_ERROR_OF_MEAN|0.213||0.4979|TWO_SIDED|95.0|-0.564|0.274|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.274|-0.564|0.4979
70914836|NCT00383188|141320463|SUPERIORITY||LSM Difference|0.271|STANDARD_ERROR_OF_MEAN|0.195||0.1643|TWO_SIDED|95.0|-0.111|0.653|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.653|-0.111|0.1643
70914837|NCT00383188|141320463|SUPERIORITY||LSM Difference|0.081|STANDARD_ERROR_OF_MEAN|0.185||0.6611|TWO_SIDED|95.0|-0.282|0.445|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.445|-0.282|0.6611
70914838|NCT00383188|141320463|SUPERIORITY||LSM Difference|0.097|STANDARD_ERROR_OF_MEAN|0.219||0.6587|TWO_SIDED|95.0|-0.333|0.526|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.526|-0.333|0.6587
70914839|NCT00383188|141320463|SUPERIORITY||LSM Difference|0.154|STANDARD_ERROR_OF_MEAN|0.223||0.4903|TWO_SIDED|95.0|-0.284|0.592|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.592|-0.284|0.4903
70914840|NCT00383188|141320465|SUPERIORITY||LSM Difference|-0.119|STANDARD_ERROR_OF_MEAN|0.09||0.1857|TWO_SIDED|95.0|-0.296|0.057|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.057|-0.296|0.1857
70914841|NCT00383188|141320465|SUPERIORITY||LSM Difference|-0.277|STANDARD_ERROR_OF_MEAN|0.089||0.0019|TWO_SIDED|95.0|-0.451|-0.103|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.103|-0.451|0.0019
70914842|NCT00383188|141320465|SUPERIORITY||LSM Difference|-0.244|STANDARD_ERROR_OF_MEAN|0.103||0.0178|TWO_SIDED|95.0|-0.446|-0.042|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.042|-0.446|0.0178
70914843|NCT00383188|141320465|SUPERIORITY||LSM Difference|-0.098|STANDARD_ERROR_OF_MEAN|0.106||0.3547|TWO_SIDED|95.0|-0.305|0.11|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.110|-0.305|0.3547
70914844|NCT00383188|141320465|SUPERIORITY||LSM Difference|-0.135|STANDARD_ERROR_OF_MEAN|0.089||0.1301|TWO_SIDED|95.0|-0.31|0.04|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.040|-0.310|0.1301
70914845|NCT00383188|141320465|SUPERIORITY||LSM Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.088||0.0313|TWO_SIDED|95.0|-0.363|-0.017|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.017|-0.363|0.0313
70914846|NCT00383188|141320465|SUPERIORITY||LSM Difference|-0.219|STANDARD_ERROR_OF_MEAN|0.102||0.0323|TWO_SIDED|95.0|-0.42|-0.019|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.019|-0.420|0.0323
70914847|NCT00383188|141320465|SUPERIORITY||LSM Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.105||0.6318|TWO_SIDED|95.0|-0.256|0.156|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.156|-0.256|0.6318
70914848|NCT00383188|141320465|SUPERIORITY||LSM Difference|-0.055|STANDARD_ERROR_OF_MEAN|0.089||0.5388|TWO_SIDED|95.0|-0.23|0.12|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.120|-0.230|0.5388
70914849|NCT00383188|141320465|SUPERIORITY||LSM Difference|-0.157|STANDARD_ERROR_OF_MEAN|0.088||0.0755|TWO_SIDED|95.0|-0.329|0.016|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.016|-0.329|0.0755
70914850|NCT00383188|141320465|SUPERIORITY||LSM Difference|-0.219|STANDARD_ERROR_OF_MEAN|0.102||0.0323|TWO_SIDED|95.0|-0.42|-0.019|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.019|-0.420|0.0323
70914851|NCT00383188|141320465|SUPERIORITY||LSM Difference|-0.072|STANDARD_ERROR_OF_MEAN|0.105||0.4948|TWO_SIDED|95.0|-0.277|0.134|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.134|-0.277|0.4948
70914852|NCT00383188|141320465|SUPERIORITY||LSM Difference|0.06|STANDARD_ERROR_OF_MEAN|0.089||0.5022|TWO_SIDED|95.0|-0.115|0.235|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.235|-0.115|0.5022
70914853|NCT00383188|141320465|SUPERIORITY||LSM Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.088||0.0307|TWO_SIDED|95.0|-0.363|-0.018|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.018|-0.363|0.0307
70914854|NCT00383188|141320465|SUPERIORITY||LSM Difference|-0.172|STANDARD_ERROR_OF_MEAN|0.102||0.0933|TWO_SIDED|95.0|-0.372|0.029|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.029|-0.372|0.0933
70914855|NCT00383188|141320465|SUPERIORITY||LSM Difference|0.027|STANDARD_ERROR_OF_MEAN|0.105||0.7967|TWO_SIDED|95.0|-0.179|0.233|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.233|-0.179|0.7967
71092944|NCT03881371|141692491|SUPERIORITY||Least-Square Mean|-1.52|STANDARD_ERROR_OF_MEAN|0.51||0.0033|TWO_SIDED|95.0|-2.521|-0.511||ANCOVA with treatment and centre as independent factors, baseline UPDRS part II (ADL) score as covariate and change from baseline as dependent variable.|ANCOVA|||Treatment difference (Safinamide - Placebo)||-0.511|-2.521|0.0033
70914856|NCT00383188|141320465|SUPERIORITY||LSM Difference|-0.034|STANDARD_ERROR_OF_MEAN|0.089||0.7059|TWO_SIDED|95.0|-0.208|0.141|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.141|-0.208|0.7059
70970697|NCT00531752|141447064|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5285|STANDARD_ERROR_OF_MEAN|0.1847||0.0059|TWO_SIDED|80.0|0.28911|0.76798|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.76798|0.28911|0.0059
71092945|NCT03881371|141692492|SUPERIORITY||Least-Square Mean|-3.8|STANDARD_ERROR_OF_MEAN|0.988||0.0002|TWO_SIDED|95.0|-5.749|-1.856||ANCOVA with treatment and centre as independent factors, baseline UPDRS part III (motor function) score as covariate and change from baseline as dependent variable.|ANCOVA|||Treatment difference (Safinamide - Placebo)||-1.856|-5.749|0.0002
70914857|NCT00383188|141320465|SUPERIORITY||LSM Difference|-0.213|STANDARD_ERROR_OF_MEAN|0.088||0.0154|TWO_SIDED|95.0|-0.386|-0.041|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.041|-0.386|0.0154
70914858|NCT00383188|141320465|SUPERIORITY||LSM Difference|-0.136|STANDARD_ERROR_OF_MEAN|0.102||0.1836|TWO_SIDED|95.0|-0.336|0.065|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.065|-0.336|0.1836
70914859|NCT00383188|141320465|SUPERIORITY||LSM Difference|0.078|STANDARD_ERROR_OF_MEAN|0.105||0.4577|TWO_SIDED|95.0|-0.128|0.284|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.284|-0.128|0.4577
70914860|NCT00383188|141320465|SUPERIORITY||LSM Difference|0.082|STANDARD_ERROR_OF_MEAN|0.092||0.3692|TWO_SIDED|95.0|-0.098|0.262|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.262|-0.098|0.3692
70914861|NCT00383188|141320465|SUPERIORITY||LSM Difference|0.065|STANDARD_ERROR_OF_MEAN|0.09||0.4677|TWO_SIDED|95.0|-0.111|0.241|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.241|-0.111|0.4677
70914862|NCT00383188|141320465|SUPERIORITY||LSM Difference|0.1|STANDARD_ERROR_OF_MEAN|0.106||0.3427|TWO_SIDED|95.0|-0.107|0.307|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.307|-0.107|0.3427
70914863|NCT00383188|141320465|SUPERIORITY||LSM Difference|0.135|STANDARD_ERROR_OF_MEAN|0.108||0.212|TWO_SIDED|95.0|-0.077|0.347|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.347|-0.077|0.2120
70914864|NCT00383188|141320466|SUPERIORITY||LSM Difference|-0.587|STANDARD_ERROR_OF_MEAN|0.337||0.0815|TWO_SIDED|95.0|-1.248|0.074|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.074|-1.248|0.0815
70914865|NCT00383188|141320466|SUPERIORITY||LSM Difference|-1.057|STANDARD_ERROR_OF_MEAN|0.331||0.0015|TWO_SIDED|95.0|-1.707|-0.407|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.407|-1.707|0.0015
70914866|NCT00383188|141320466|SUPERIORITY||LSM Difference|-1.107|STANDARD_ERROR_OF_MEAN|0.385||0.0042|TWO_SIDED|95.0|-1.863|-0.351|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.351|-1.863|0.0042
70914867|NCT00383188|141320466|SUPERIORITY||LSM Difference|-0.842|STANDARD_ERROR_OF_MEAN|0.398||0.0348|TWO_SIDED|95.0|-1.624|-0.06|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.060|-1.624|0.0348
70914868|NCT00383188|141320466|SUPERIORITY||LSM Difference|-0.442|STANDARD_ERROR_OF_MEAN|0.332||0.1843|TWO_SIDED|95.0|-1.095|0.211|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.211|-1.095|0.1843
70914869|NCT00383188|141320466|SUPERIORITY||LSM Difference|-0.582|STANDARD_ERROR_OF_MEAN|0.327||0.076|TWO_SIDED|95.0|-1.225|0.061|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.061|-1.225|0.0760
70914870|NCT00383188|141320466|SUPERIORITY||LSM Difference|-1.019|STANDARD_ERROR_OF_MEAN|0.382||0.0078|TWO_SIDED|95.0|-1.769|-0.27|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.270|-1.769|0.0078
70914871|NCT00383188|141320466|SUPERIORITY||LSM Difference|-0.517|STANDARD_ERROR_OF_MEAN|0.395||0.1905|TWO_SIDED|95.0|-1.292|0.258|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.258|-1.292|0.1905
70914872|NCT00383188|141320466|SUPERIORITY||LSM Difference|-0.149|STANDARD_ERROR_OF_MEAN|0.332||0.6552|TWO_SIDED|95.0|-0.801|0.504|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.504|-0.801|0.6552
70914873|NCT00383188|141320466|SUPERIORITY||LSM Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.327||0.0281|TWO_SIDED|95.0|-1.363|-0.078|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.078|-1.363|0.0281
70970698|NCT00531752|141447064|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1526|STANDARD_ERROR_OF_MEAN|0.1431||0.2921|TWO_SIDED|80.0|-0.0336|0.33878|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.33878|-0.0336|0.2921
70914874|NCT00383188|141320466|SUPERIORITY||LSM Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.382||0.0263|TWO_SIDED|95.0|-1.599|-0.1|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.100|-1.599|0.0263
70914875|NCT00383188|141320466|SUPERIORITY||LSM Difference|-0.429|STANDARD_ERROR_OF_MEAN|0.395||0.2772|TWO_SIDED|95.0|-1.204|0.346|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.346|-1.204|0.2772
70914876|NCT00383188|141320466|SUPERIORITY||LSM Difference|-0.024|STANDARD_ERROR_OF_MEAN|0.332||0.9433|TWO_SIDED|95.0|-0.676|0.629|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.629|-0.676|0.9433
70914877|NCT00383188|141320466|SUPERIORITY||LSM Difference|-0.768|STANDARD_ERROR_OF_MEAN|0.327||0.193|TWO_SIDED|95.0|-1.41|-0.125|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.125|-1.410|0.193
70914878|NCT00383188|141320466|SUPERIORITY||LSM Difference|-0.763|STANDARD_ERROR_OF_MEAN|0.382||0.461|TWO_SIDED|95.0|-1.512|-0.013|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.013|-1.512|0.461
70914879|NCT00383188|141320466|SUPERIORITY||LSM Difference|-0.254|STANDARD_ERROR_OF_MEAN|0.395||0.52|TWO_SIDED|95.0|-1.029|0.521|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.521|-1.029|0.5200
70914880|NCT00383188|141320466|SUPERIORITY||LSM Difference|-0.476|STANDARD_ERROR_OF_MEAN|0.332||0.1526|TWO_SIDED|95.0|-1.129|0.177|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.177|-1.129|0.1526
70914881|NCT00383188|141320466|SUPERIORITY||LSM Difference|-1.095|STANDARD_ERROR_OF_MEAN|0.327||0.0009|TWO_SIDED|95.0|-1.738|-0.453|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.453|-1.738|0.0009
70914882|NCT00383188|141320466|SUPERIORITY||LSM Difference|-0.523|STANDARD_ERROR_OF_MEAN|0.382||0.1711|TWO_SIDED|95.0|-1.273|0.227|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.227|-1.273|0.1711
70914883|NCT00383188|141320466|SUPERIORITY||LSM Difference|-0.563|STANDARD_ERROR_OF_MEAN|0.395||0.1539|TWO_SIDED|95.0|-1.338|0.211|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.211|-1.338|0.1539
70914884|NCT00383188|141320466|SUPERIORITY||LSM Difference|-0.512|STANDARD_ERROR_OF_MEAN|0.36||0.1554|TWO_SIDED|95.0|-1.219|0.195|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.195|-1.219|0.1554
70914885|NCT00383188|141320466|SUPERIORITY||LSM Difference|-0.889|STANDARD_ERROR_OF_MEAN|0.354||0.0124|TWO_SIDED|95.0|-1.585|-0.193|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.193|-1.585|0.0124
70914886|NCT00383188|141320466|SUPERIORITY||LSM Difference|-0.914|STANDARD_ERROR_OF_MEAN|0.412||0.0268|TWO_SIDED|95.0|-1.723|-0.106|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.106|-1.723|0.0268
70914887|NCT00383188|141320466|SUPERIORITY||LSM Difference|-0.681|STANDARD_ERROR_OF_MEAN|0.427||0.1113|TWO_SIDED|95.0|-1.519|0.158|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.158|-1.519|0.1113
70914888|NCT00383188|141320466|SUPERIORITY||LSM Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.356||0.1305|TWO_SIDED|95.0|-1.24|0.16|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.160|-1.240|0.1305
70914889|NCT00383188|141320466|SUPERIORITY||LSM Difference|-0.571|STANDARD_ERROR_OF_MEAN|0.351||0.1043|TWO_SIDED|95.0|-1.261|0.118|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.118|-1.261|0.1043
70914890|NCT00383188|141320466|SUPERIORITY||LSM Difference|-1.017|STANDARD_ERROR_OF_MEAN|0.409||0.0131|TWO_SIDED|95.0|-1.82|-0.214|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.214|-1.820|0.0131
70914891|NCT00383188|141320466|SUPERIORITY||LSM Difference|-0.492|STANDARD_ERROR_OF_MEAN|0.424||0.2459|TWO_SIDED|95.0|-1.324|0.34|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.340|-1.324|0.2459
70914892|NCT00383188|141320466|SUPERIORITY||LSM Difference|-0.221|STANDARD_ERROR_OF_MEAN|0.356||0.536|TWO_SIDED|95.0|-0.921|0.479|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.479|-0.921|0.5360
71092946|NCT03881371|141692493|SUPERIORITY||Median|0.0||||0.015|TWO_SIDED|95.0|0.0|0.0||Analysis was based on the Wilcoxon-Mann-Whitney test stratified by centre.|Wilcoxon (Mann-Whitney)||Non-parametric 95% confidence interval was presented for the treatment difference in CGI-S at each post-baseline visit as reported by the Hodges-Lehmann estimator.|Treatment difference (Safinamide - Placebo)||0.000|0.000|0.0150
70914893|NCT00383188|141320466|SUPERIORITY||LSM Difference|-0.465|STANDARD_ERROR_OF_MEAN|0.351||0.1858|TWO_SIDED|95.0|-1.155|0.225|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.225|-1.155|0.1858
70914894|NCT00383188|141320466|SUPERIORITY||LSM Difference|-0.821|STANDARD_ERROR_OF_MEAN|0.409||0.0451|TWO_SIDED|95.0|-1.624|-0.018|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.018|-1.624|0.0451
70914895|NCT00383188|141320466|SUPERIORITY||LSM Difference|-0.189|STANDARD_ERROR_OF_MEAN|0.424||0.6551|TWO_SIDED|95.0|-1.021|0.643|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.643|-1.021|0.6551
70914896|NCT00383188|141320466|SUPERIORITY||LSM Difference|0.018|STANDARD_ERROR_OF_MEAN|0.356||0.9602|TWO_SIDED|95.0|-0.682|0.718|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.718|-0.682|0.9602
70914897|NCT00383188|141320466|SUPERIORITY||LSM Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.351||0.0198|TWO_SIDED|95.0|-1.51|-0.131|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.131|-1.510|0.0198
70914898|NCT00383188|141320466|SUPERIORITY||LSM Difference|-0.948|STANDARD_ERROR_OF_MEAN|0.409||0.0208|TWO_SIDED|95.0|-1.751|-0.145|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.145|-1.751|0.0208
70914899|NCT00383188|141320466|SUPERIORITY||LSM Difference|-0.433|STANDARD_ERROR_OF_MEAN|0.424||0.3077|TWO_SIDED|95.0|-1.265|0.4|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.400|-1.265|0.3077
70914900|NCT00383188|141320466|SUPERIORITY||LSM Difference|-0.211|STANDARD_ERROR_OF_MEAN|0.356||0.555|TWO_SIDED|95.0|-0.911|0.49|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.490|-0.911|0.5550
70914901|NCT00383188|141320466|SUPERIORITY||LSM Difference|-0.795|STANDARD_ERROR_OF_MEAN|0.351||0.0239|TWO_SIDED|95.0|-1.485|-0.106|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.106|-1.485|0.0239
70914902|NCT00383188|141320466|SUPERIORITY||LSM Difference|-0.613|STANDARD_ERROR_OF_MEAN|0.409||0.1342|TWO_SIDED|95.0|-1.416|0.19|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.190|-1.416|0.1342
70914903|NCT00383188|141320466|SUPERIORITY||LSM Difference|-0.367|STANDARD_ERROR_OF_MEAN|0.424||0.3868|TWO_SIDED|95.0|-1.199|0.465|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.465|-1.199|0.3868
70914904|NCT00383188|141320467|SUPERIORITY||LSM Difference|0.792|STANDARD_ERROR_OF_MEAN|1.093||0.4693|TWO_SIDED|95.0|-1.357|2.941|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||2.941|-1.357|0.4693
70914905|NCT00383188|141320467|SUPERIORITY||LSM Difference|1.927|STANDARD_ERROR_OF_MEAN|1.077||0.0743|TWO_SIDED|95.0|-0.19|4.044|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||4.044|-0.190|0.0743
71092947|NCT03881371|141692494|SUPERIORITY||Median|0.5||||0.0007|TWO_SIDED|95.0|0.0|1.0||Analysis was based on the Wilcoxon-Mann-Whitney test stratified by centre.|Wilcoxon (Mann-Whitney)||Non-parametric 95% confidence interval was presented for the treatment difference in CGI-C score at each post-baseline visit as reported by the Hodges-Lehmann estimator.|Treatment difference (Safinamide - Placebo)||1.000|0.000|0.0007
70914906|NCT00383188|141320467|SUPERIORITY||LSM Difference|4.196|STANDARD_ERROR_OF_MEAN|1.286||0.0012|TWO_SIDED|95.0|1.668|6.723|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||6.723|1.668|0.0012
70914907|NCT00383188|141320467|SUPERIORITY||LSM Difference|1.236|STANDARD_ERROR_OF_MEAN|1.308||0.3452|TWO_SIDED|95.0|-1.335|3.807|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||3.807|-1.335|0.3452
70914908|NCT00383188|141320467|SUPERIORITY||LSM Difference|1.095|STANDARD_ERROR_OF_MEAN|1.091||0.3162|TWO_SIDED|95.0|-1.05|3.239|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||3.239|-1.050|0.3162
70914909|NCT00383188|141320467|SUPERIORITY||LSM Difference|2.514|STANDARD_ERROR_OF_MEAN|1.072||0.0195|TWO_SIDED|95.0|0.406|4.622|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||4.622|0.406|0.0195
70914910|NCT00383188|141320467|SUPERIORITY||LSM Difference|2.762|STANDARD_ERROR_OF_MEAN|1.283||0.032|TWO_SIDED|95.0|0.239|5.285|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||5.285|0.239|0.0320
70914911|NCT00383188|141320467|SUPERIORITY||LSM Difference|0.268|STANDARD_ERROR_OF_MEAN|1.29||0.8356|TWO_SIDED|95.0|-2.268|2.804|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||2.804|-2.268|0.8356
70914912|NCT00383188|141320467|SUPERIORITY||LSM Difference|-0.904|STANDARD_ERROR_OF_MEAN|1.626||0.5787|TWO_SIDED|95.0|-4.101|2.293|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||2.293|-4.101|0.5787
70914913|NCT00383188|141320467|SUPERIORITY||LSM Difference|1.291|STANDARD_ERROR_OF_MEAN|1.6||0.4203|TWO_SIDED|95.0|-1.854|4.436|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||4.436|-1.854|0.4203
70914914|NCT00383188|141320467|SUPERIORITY||LSM Difference|2.318|STANDARD_ERROR_OF_MEAN|1.916||0.2272|TWO_SIDED|95.0|-1.449|6.084|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||6.084|-1.449|0.2272
70914915|NCT00383188|141320467|SUPERIORITY||LSM Difference|0.829|STANDARD_ERROR_OF_MEAN|1.947||0.6707|TWO_SIDED|95.0|-2.998|4.655|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||4.655|-2.998|0.6707
70914916|NCT00383188|141320467|SUPERIORITY||LSM Difference|0.425|STANDARD_ERROR_OF_MEAN|1.622||0.7935|TWO_SIDED|95.0|-2.764|3.613|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||3.613|-2.764|0.7935
70914917|NCT00383188|141320467|SUPERIORITY||LSM Difference|2.525|STANDARD_ERROR_OF_MEAN|1.592||0.1135|TWO_SIDED|95.0|-0.605|5.655|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||5.655|-0.605|0.1135
70914918|NCT00383188|141320467|SUPERIORITY||LSM Difference|2.63|STANDARD_ERROR_OF_MEAN|1.912||0.1697|TWO_SIDED|95.0|-1.128|6.388|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||6.388|-1.128|0.1697
70914919|NCT00383188|141320467|SUPERIORITY||LSM Difference|2.21|STANDARD_ERROR_OF_MEAN|1.918||0.25|TWO_SIDED|95.0|-1.561|5.981|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||5.981|-1.561|0.2500
71092948|NCT03881371|141692495|SUPERIORITY||Least-Square Mean|-3.36|STANDARD_ERROR_OF_MEAN|1.132||0.0033|TWO_SIDED|95.0|-5.589|-1.128||ANCOVA with treatment and centre as independent factor, baseline Summary Index score as covariate and change from baseline as dependent variable.|ANCOVA|||Treatment difference (Safinamide - Placebo)||-1.128|-5.589|0.0033
70914920|NCT01093534|141320476|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.169||||0.095|TWO_SIDED|95.0|-0.368|0.03||Hochberg Method for controlling the overall risk of type I error of 5% was used to adjust for using two co-primary endpoints.|ANCOVA|ANCOVA model with fixed effects for treatment and region and Baseline of least squares mean BWT as a covariate.||The null hypothesis was that the mean change from Baseline in BWT in the pooled solifenacin group and placebo was the same. Estimated as two-sided contrast with 95% confidence interval. Power was planned for 80% (assumption: mean difference = 0.5 mm, standard deviation=1.65, 314 and 157 participants, bonferroni adjustment for alpha =0.025)||0.030|-0.368|0.095
70970699|NCT00531752|141447064|SUPERIORITY_OR_OTHER||LS Mean Difference|0.198|STANDARD_ERROR_OF_MEAN|0.1498||0.1929|TWO_SIDED|80.0|0.00319|0.39272|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.39272|0.00319|0.1929
71092949|NCT00933933|141692497|SUPERIORITY_OR_OTHER||Clinical Specificity|99.77|||||TWO_SIDED|95.0|99.62|99.88|||Exact binomial|||||99.88|99.62|
71092950|NCT00933933|141692498|SUPERIORITY_OR_OTHER||Clinical Sensitivity|100.0|||||TWO_SIDED|95.0|94.31|100.0|||Exact binomial|||||100.00|94.31|
70914921|NCT01093534|141320477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25||||||Hochberg Method for controlling the overall risk of type I error of 5% was used to adjust for using two co-primary endpoints.|Wilcoxon (Mann-Whitney)|Nonparametric Wilcoxon rank-sum test does not adjust for other factors.||The null hypothesis for the co-primary treatment comparison was that the mean free (neutralized) uNGF/Cr value in the pooled solifenacin group and placebo was the same. Wilcoxon rank-sum test was used instead of a contrast from analysis of covariance (ANCOVA), because data was not normally distributed. Power was planned for 80% (assumption: mean difference = 0.74 pg/μmol, standard deviation=2.0, 220 and 110 participants, bonferroni adjustment for alpha =0.025).||||0.250
70914922|NCT00281918|141320501|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||||||<.0001
70914923|NCT00281918|141320502|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||||||<.0001
70914924|NCT00281918|141320503|SUPERIORITY_OR_OTHER|||||||0.0427||95.0|||||Log Rank|||||||0.0427
70914925|NCT00281918|141320504|SUPERIORITY_OR_OTHER|||||||0.7882||95.0|||||Log Rank|||||||0.7882
70914926|NCT00281918|141320505|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.48|0.67|||Log Rank|||||0.67|0.48|<.0001
70914927|NCT00281918|141320506|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.001|TWO_SIDED|95.0|0.54|0.86|||Log Rank|||||0.86|0.54|0.0010
70914928|NCT00281918|141320507|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57|||<|0.0001||95.0|0.48|0.67|||Log Rank|||||0.67|0.48|<.0001
70914929|NCT00281918|141320508|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0523|TWO_SIDED|95.0|0.52|1.02|||Log Rank|||||1.02|0.52|0.0523
70914930|NCT00281918|141320509|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.48|0.71|||Log Rank|||||0.71|0.48|<.0001
70914931|NCT00281918|141320510|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.0001|TWO_SIDED|95.0|1.62|3.28|||Chi-squared|||||3.28|1.62|<.0001
70914932|NCT00281918|141320511|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.49|0.72|||Log Rank|||||0.72|0.49|<.0001
70914933|NCT01670110|141320525|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.001
70914934|NCT01670110|141320526|SUPERIORITY|||||||0.003|||||||ANCOVA|||||||0.003
70914935|NCT01670110|141320527|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.79
71092951|NCT00933933|141692498|SUPERIORITY_OR_OTHER||Clinical Sensitivity|100.0|||||TWO_SIDED|95.0|99.63|100.0|||Exact binomial|||||100.00|99.63|
70914936|NCT01670110|141320528|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.79
70914937|NCT01670110|141320529|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
70914938|NCT01670110|141320530|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
70914939|NCT01670110|141320531|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||||||0.73
71092952|NCT00933933|141692498|SUPERIORITY_OR_OTHER||Clinical Sensitivity|100.0|||||TWO_SIDED|95.0|98.18|100.0|||Exact binomial|||||100.00|98.18|
70914940|NCT01670110|141320532|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||Physical functioning||||0.31
70914941|NCT01670110|141320532|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||Physical role||||0.48
70914942|NCT01670110|141320532|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||Bodily pain||||0.89
70914943|NCT01670110|141320532|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||General health||||0.18
70914944|NCT01670110|141320532|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||Vitality||||0.28
70914945|NCT01670110|141320532|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||Social functioning||||0.66
70914946|NCT01670110|141320532|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||Role emotional||||0.43
70914947|NCT01670110|141320532|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||Mental health||||0.51
70914948|NCT03418324|141320537|OTHER|Binomial proportion (Clopper-Pearson exact confidence interval) for each arm|Binomial proportion|50.0|||||TWO_SIDED|95.0|1.3|98.7|||||Estimated values reflects the percentage of participants with overall clinical benefit.|For this study, we are not comparing outcome measures between the two arms||98.7|1.3|
70914949|NCT03418324|141320537|OTHER|Binomial proportion (Clopper-Pearson exact confidence interval) for each arm|Binomial proportion|66.7|||||TWO_SIDED|95.0|22.3|95.7|||||Estimated values reflects the percentage of participants with overall clinical benefit|For this study, we are not comparing outcome measures between the two groups.||95.7|22.3|
70914950|NCT03418324|141320540|OTHER|Binomial proportion (Clopper-Pearson exact confidence interval) for each arm.|Binomial proportion|50.0|||||TWO_SIDED|95.0|1.3|98.7||||||For this study, we are not comparing outcome measures between the two arms||98.7|1.3|
70914951|NCT03418324|141320540|OTHER|Binomial proportion (Clopper-Pearson exact confidence interval) for each arm.|Binomial proportion|66.7|||||TWO_SIDED|95.0|22.3|95.7||||||For this study, we are not comparing outcome measures between the two arms.||95.7|22.3|
70914952|NCT03418324|141320541|OTHER|Binomial proportion (Clopper-Pearson exact confidence interval) for each arm.|Binomial proportion|50.0|||||TWO_SIDED|95.0|1.3|98.7||||||For this study, we are not comparing outcome measures between the two arms.||98.7|1.3|
70914953|NCT03418324|141320541|OTHER|Binomial proportion (Clopper-Pearson exact confidence interval) for each arm.|Binomial proportion|50.0|||||TWO_SIDED|95.0|11.8|88.2||||||For this study, we are not comparing outcome measures between the two arms.||88.2|11.8|
70914954|NCT01768676|141320544|NON_INFERIORITY_OR_EQUIVALENCE|The difference in percentage of subjects with a \>/= 50% reduction from baseline to Week 26 in sperm concentration between treatment arms was analyzed using Cochran-Mantel-Haenszel method to account for the randomization stratification by baseline sperm concentration. If upper limit of 95% CI \< 20% then avanafil is considered non-inferior to placebo.|Risk Difference (RD)|-12.93|STANDARD_ERROR_OF_MEAN|4.41|||TWO_SIDED|95.0|-21.56|-4.29|||||Confidence interval was only calculated for primary endpoint of the difference between avanafil and placebo, not for each individual arm.|||-4.29|-21.56|
70914955|NCT01768676|141320545|NON_INFERIORITY_OR_EQUIVALENCE|If upper limit of 95% CI \< 20% then avanafil is considered non-inferior to placebo.|Risk Difference (RD)|-11.4|STANDARD_ERROR_OF_MEAN|6.2|||TWO_SIDED|95.0|-23.5|0.7|||||Confidence interval was only calculated for primary endpoint of the difference between avanafil and placebo, not for each individual arm.|||0.7|-23.5|
71092953|NCT00933933|141692499|SUPERIORITY_OR_OTHER||Clinical Specificity|100.0|||||TWO_SIDED|95.0|99.18|100.0|||Exact binomial|||||100.00|99.18|
71092954|NCT00933933|141692499|SUPERIORITY_OR_OTHER||Clinical Sensitivity|100.0|||||TWO_SIDED|95.0|94.48|100.0|||Exact binomial|||||100.00|94.48|
71092955|NCT00933933|141692500|SUPERIORITY_OR_OTHER||Clinical Specificity|99.83|||||TWO_SIDED|95.0|99.06|100.0|||Exact binomial|||||100.00|99.06|
70914956|NCT01768676|141320546|NON_INFERIORITY_OR_EQUIVALENCE|If upper limit of 95% CI \< 20% then avanafil is considered non-inferior to placebo.|Risk Difference (RD)|-1.4|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|-4.2|1.3|||||Confidence interval was only calculated for primary endpoint of the difference between avanafil and placebo, not for each individual arm.|||1.3|-4.2|
70914957|NCT01768676|141320547|NON_INFERIORITY_OR_EQUIVALENCE|If upper limit of 95% CI \< 20% then avanafil is considered non-inferior to placebo.|Risk Difference (RD)|-2.9|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|-6.8|1.1|||||Confidence interval was only calculated for primary endpoint of the difference between avanafil and placebo, not for each individual arm.|||1.1|-6.8|
70914958|NCT01768676|141320548|NON_INFERIORITY_OR_EQUIVALENCE|If upper limit of 95% CI \< 20% then avanafil is considered non-inferior to placebo.|Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|0.0|||TWO_SIDED|95.0|0.0|0.0|||||Confidence interval was only calculated for primary endpoint of the difference between avanafil and placebo, not for each individual arm.|||0|0|
70914959|NCT00771667|141320588|SUPERIORITY_OR_OTHER|||||||0.005||||||A fixed sequence testing procedure was employed to control the type I error rate at 0.05 level for the primary endpoint, beginning with the highest dose.|Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.005
70914960|NCT00771667|141320588|SUPERIORITY_OR_OTHER|||||||0.057||||||A fixed sequence testing procedure was employed to control the type I error rate at 0.05 level for the primary endpoint, beginning with the highest dose.|Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.057
70914961|NCT00771667|141320588|SUPERIORITY_OR_OTHER|||||||0.021||||||A fixed sequence testing procedure was employed to control the type I error rate at 0.05 level for the primary endpoint, beginning with the highest dose.|Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.021
70914962|NCT00771667|141320589|SUPERIORITY_OR_OTHER|||||||0.682|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.682
70914963|NCT00771667|141320589|SUPERIORITY_OR_OTHER|||||||0.206|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.206
70914964|NCT00771667|141320589|SUPERIORITY_OR_OTHER|||||||0.196|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.196
70914965|NCT00771667|141320590|SUPERIORITY_OR_OTHER|||||||0.008|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.008
70914966|NCT00771667|141320590|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||<0.001
70914967|NCT00771667|141320590|SUPERIORITY_OR_OTHER|||||||0.035|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.035
71092956|NCT00933933|141692500|SUPERIORITY_OR_OTHER||Clinical Sensitivity|100.0|||||TWO_SIDED|95.0|94.4|100.0|||Exact binomial|||||100.00|94.40|
70914968|NCT00771667|141320591|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||<0.001
70914969|NCT00771667|141320591|SUPERIORITY_OR_OTHER|||||||0.007|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.007
70914970|NCT00771667|141320591|SUPERIORITY_OR_OTHER|||||||0.006|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.006
70914971|NCT00771667|141320592|SUPERIORITY_OR_OTHER|||||||0.074|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.074
70914972|NCT00771667|141320592|SUPERIORITY_OR_OTHER|||||||0.081|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.081
70914973|NCT00771667|141320592|SUPERIORITY_OR_OTHER|||||||0.105|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.105
70914974|NCT00771667|141320593|SUPERIORITY_OR_OTHER|||||||0.029||||||Testing for Week-22 clinical remission was performed if the comparison of 6-mg/kg ustekinumab with placebo was positive for the primary endpoint.|Cochran-Mantel-Haenszel|The CMH test chi-square test, stratified by IV induction dose and clinical remission status at Week 6.||||||0.029
71092957|NCT05850494|141692535|NON_INFERIORITY|Non-inferiority margin of -0.200 L at a one-sided significance level of 0.025.|Mean Difference (Net)|-0.009|STANDARD_ERROR_OF_MEAN|0.0136|||TWO_SIDED|95.0|-0.037|0.018||P-Value not applicable since a non-inferiority test was used for the analysis.|Mixed Models Analysis|||||0.018|-0.037|
70914975|NCT00771667|141320594|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for induction dose and clinical remission status at Week 6.||||||<0.001
70914976|NCT04059237|141320700|OTHER||||||<|0.001||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||<0.001
71092958|NCT00695019|141692620|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61||95.0|||||Chi-squared|||||||0.61
70914977|NCT04059237|141320701|OTHER||||||<|0.001||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||<.001
70914978|NCT04059237|141320702|OTHER||||||<|0.001||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||<0.001
70914979|NCT04059237|141320703|OTHER|||||||0.1||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||0.10
70914980|NCT04059237|141320704|OTHER|||||||0.01||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||.01
70914981|NCT04059237|141320705|OTHER|||||||0.59||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||0.59
70914982|NCT04059237|141320706|OTHER|||||||0.02||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||0.02
70914983|NCT04059237|141320707|OTHER|||||||0.52||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||0.52
70914984|NCT04059237|141320708|OTHER|||||||0.08||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||0.08
70914985|NCT01460342|141320727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-2.4|-0.6|||Mixed Models Analysis|||||-0.6|-2.4|<0.001
70914986|NCT01460342|141320728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.0|-0.5||The p-value is for the change from baseline in the IPSS Total Score at Week 4.|Mixed Models Analysis|||||-0.5|-2.0|<0.001
70914987|NCT01460342|141320728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.4||0.003|TWO_SIDED|95.0|-2.0|-0.4||The p-value is for the change from baseline in the IPSS Total Score at Week 8.|Mixed Models Analysis|||||-0.4|-2.0|0.003
71092959|NCT00695019|141692621|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48||95.0|||||Chi-squared|||||||0.48
70914988|NCT01460342|141320729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.09|TWO_SIDED|95.0|-0.6|0.0||The p-value was for the change from baseline in the IPSS Storage (Irritative) Subscore at Week 4.|Mixed Models Analysis|||||0.0|-0.6|0.090
70914989|NCT01460342|141320729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.011|TWO_SIDED|95.0|-0.8|-0.1||The p-value was for the change from baseline in the IPSS Storage (Irritative) Subscore at Week 8.|Mixed Models Analysis|||||-0.1|-0.8|0.011
70914990|NCT01460342|141320729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.002|TWO_SIDED|95.0|-0.9|-0.2||The p-value was for the change from baseline in the IPSS Storage (Irritative) Subscore at Week 12.|Mixed Models Analysis|||||-0.2|-0.9|0.002
70914991|NCT01460342|141320730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.5|-0.4||The p-value was for the change from baseline in the IPSS Voiding (Obstructive) Subscore at Week 4.|Mixed Models Analysis|||||-0.4|-1.5|<0.001
70914992|NCT01460342|141320730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.3||0.007|TWO_SIDED|95.0|-1.3|-0.2||The p-value was for the change from baseline in the IPSS Voiding (Obstructive) Subscore at Week 8.|Mixed Models Analysis|||||-0.2|-1.3|0.007
70914993|NCT01460342|141320730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.3||0.002|TWO_SIDED|95.0|-1.5|-0.3||The p-value was for the change from baseline in the IPSS Voiding (Obstructive) Subscore at Week 12.|Mixed Models Analysis|||||-0.3|-1.5|0.002
70914994|NCT01460342|141320731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.277|TWO_SIDED|95.0|-0.2|0.1||The p-value was for the change from baseline in the IPSS QoL Index Score at Week 4.|Mixed Models Analysis|||||0.1|-0.2|0.277
70914995|NCT01460342|141320731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.17|TWO_SIDED|95.0|-0.3|0.1||The p-value was for the change from baseline in the IPSS QoL Index Score at Week 8.|Mixed Models Analysis|||||0.1|-0.3|0.170
70914996|NCT01460342|141320731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.038|TWO_SIDED|95.0|-0.4|0.0||The p-value was for the change from baseline in the IPSS QoL Index Score at Week 12.|Mixed Models Analysis|||||-0.0|-0.4|0.038
70914997|NCT01460342|141320732|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value was from the Cochran-Mantel-Haenszel test adjusted for baseline severity of benign prostatic hyperplasia lower urinary tract symptoms (BPH-LUTS) and previous alpha-blocker therapy.|Cochran-Mantel-Haenszel|||||||<0.001
70914998|NCT01460342|141320733|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value was from the Cochran-Mantel-Haenszel test adjusted for baseline severity of benign prostatic hyperplasia lower urinary tract symptoms (BPH-LUTS) and previous alpha-blocker therapy.|Cochran-Mantel-Haenszel|||||||<0.001
70914999|NCT01460342|141320734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.06|TWO_SIDED|95.0|-1.2|0.0|||ANCOVA|||||0.0|-1.2|0.060
70915000|NCT01689519|141320735|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51||||0.0001|TWO_SIDED|95.0|0.39|0.68||The analysis was stratified by geographic region and metastasis classification (disease stage).|Log Rank|||Primary Analysis 9 May 2014||0.68|0.39|0.0001
70915001|NCT01689519|141320735|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.46|0.72||The analysis was stratified by geographic region and metastasis classification (disease stage).|Log Rank|||Post hoc Efficacy Analysis: 16 January 2015||0.72|0.46|<0.0001
70915002|NCT01689519|141320735|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.53|0.79||The analysis was stratified by geographic region and metastasis classification (disease stage).|Log Rank|||Extended 5-Year Analysis: 21 July 2019||0.79|0.53|<0.0001
70915003|NCT01689519|141320736|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.645||||0.0463|TWO_SIDED|95.0|0.42|1.0||The analysis was stratified by geographic region and metastasis classification (disease stage).|Log Rank|||Primary Analysis 9 May 2014||1.00|0.42|0.0463
70915004|NCT01689519|141320736|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.65||||0.0034|TWO_SIDED|95.0|0.49|0.87||The analysis was stratified by geographic region and metastasis classification (disease stage).|Log Rank|||Post hoc Analysis 16 January 2015||0.87|0.49|0.0034
70915005|NCT01689519|141320736|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7||||0.005|TWO_SIDED|95.0|0.55|0.9||The analysis was stratified by geographic region and metastasis classification (disease stage).|Log Rank|||Final Analysis 28 August 2015||0.90|0.55|0.0050
70915006|NCT01689519|141320737|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|22.85|||<|0.0001|TWO_SIDED|95.0|14.13|31.58|||Chi-squared|||Primary Analysis: 9 May 2014||31.58|14.13|<0.0001
70915007|NCT01689519|141320737|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.6|||<|0.0001|TWO_SIDED|95.0|11.0|28.3|||Chi-squared|||Post hoc Efficacy Analysis: 16 January 2015||28.3|11.0|<0.0001
70915008|NCT01689519|141320737|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|20.0|||<|0.0001|TWO_SIDED|95.0|11.4|28.7|||Chi-squared|||Extended 5-Year Analysis: 21 July 2019||28.70|11.40|<0.0001
70915009|NCT02613364|141320750|NON_INFERIORITY|Non-inferiority is established if the difference in mean change on the ISI between YOCAS©® and CBT-I is less than 1.15. Using ANCOVA to estimate differences in mean change between YOCAS©® and CBT-I, a correlation of 0.576 (from our prior study), and a sample of 168 subjects per group, we will have sufficient (80%) power to detect non-inferiority using a margin of 1.15 at p = 0.025.|Mean Difference (Final Values)|3.52|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|2.66|4.37||The p-value shown above is from the Least Squares Mean between YOCAS - CBT-I from the Mixed Model.|Mixed Models Analysis||The comparison is YOCAS - CBT-I|Constructed a 95% confidence interval on the mean change of ISI from baseline between the arms (YOCAS - CBT-I). If the lower bound of the interval is less than 1.5 then we conclude that YOCAS is non-inferior.||4.37|2.66|<.0001
70970700|NCT00531752|141447064|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3433|STANDARD_ERROR_OF_MEAN|0.1565||0.0332|TWO_SIDED|80.0|0.13988|0.54663|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.54663|0.13988|0.0332
71092960|NCT00695019|141692622|SUPERIORITY_OR_OTHER_LEGACY|||||||0.77||95.0|||||Kruskal-Wallis|||||||0.77
71092961|NCT00695019|141692623|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3||95.0|||||Kruskal-Wallis|||||||0.30
71092962|NCT00695019|141692624|SUPERIORITY_OR_OTHER_LEGACY|||||||0.72||95.0|||||Chi-squared|||||||0.72
70915010|NCT02613364|141320751|SUPERIORITY|Using ANCOVA to estimate differences in mean change between YOCAS and health education, a correlation of 0.576 (from our prior study), and a sample size of 168 evaluable subjects per group, we will have sufficient power to detect differences on the ISI of at least 1.3, 1.5 and 1.6 (all larger than our 1.15 non-inferiority margin) at 80%, 90%, and 95% power, respectively|Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.42||0.0009|TWO_SIDED|95.0|-2.23|-0.58||the comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the ISI Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||-0.58|-2.23|0.0009
70915011|NCT02613364|141320752|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.26||0.07|TWO_SIDED|95.0|-0.98|0.04||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the ISI Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||0.04|-0.98|0.0700
70915012|NCT02613364|141320753|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|2.23|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|1.7|2.75||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - CBT-I) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the ISI Least Squares Mean difference (YOCAS - CBT-I) generated from the Mixed Model.|The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha.||2.75|1.70|<.0001
70915013|NCT02613364|141320754|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|19.73|STANDARD_ERROR_OF_MEAN|7.03||0.0052|TWO_SIDED|95.0|5.91|33.54||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||33.54|5.91|0.0052
70915014|NCT02613364|141320755|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|15.94|STANDARD_ERROR_OF_MEAN|7.12||0.0258|TWO_SIDED|95.0|1.93|29.94||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - CBT-I) generated from the Mixed Model.|Mixed Models Analysis|||||29.94|1.93|0.0258
70915015|NCT02613364|141320756|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.025||0.92|TWO_SIDED|95.0|-0.053|0.048||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|||0.048|-0.053|0.92
70915016|NCT02613364|141320757|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.026||0.07|TWO_SIDED|95.0|-0.004|0.098||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - CBT-I) generated from the Mixed Model.|The comparison of YOCAS to the CBT-I control is a traditional null hypothesis of no difference with a two-sided alpha.||0.098|-0.004|0.07
70915017|NCT02613364|141320758|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|2.27|STANDARD_ERROR_OF_MEAN|1.11||0.04|TWO_SIDED|95.0|0.09|4.44||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||4.44|0.09|0.04
70915018|NCT02613364|141320759|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|1.12||0.49|TWO_SIDED|95.0|-2.97|1.43||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - CBT-I) generated from the Mixed Model.|The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha.||1.43|-2.97|0.49
70915019|NCT02613364|141320760|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.05||0.43|TWO_SIDED|95.0|-0.13|0.05||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||0.05|-0.13|0.43
70970701|NCT00531752|141447064|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4184|STANDARD_ERROR_OF_MEAN|0.1681||0.0162|TWO_SIDED|80.0|0.20006|0.63674|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.63674|0.20006|0.0162
70915020|NCT02613364|141320761|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.7|TWO_SIDED|95.0|-0.07|0.11||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - CBT-I) generated from the Mixed Model.|The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha.||0.11|-0.07|0.70
70915021|NCT02613364|141320762|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|-1.57|STANDARD_ERROR_OF_MEAN|0.55||0.0041|TWO_SIDED|95.0|-2.65|-0.5||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||-0.50|-2.65|0.0041
70915022|NCT02613364|141320763|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|2.71|STANDARD_ERROR_OF_MEAN|0.56|<|0.0001|TWO_SIDED|95.0|1.61|3.81||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - CBT-I) generated from the Mixed Model.|The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha.||3.81|1.61|<.0001
70915023|NCT02613364|141320764|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|-1.57|STANDARD_ERROR_OF_MEAN|0.62||0.0108|TWO_SIDED|95.0|-2.78|-0.36||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||-0.36|-2.78|0.0108
70915024|NCT02613364|141320765|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|2.78|STANDARD_ERROR_OF_MEAN|0.63|<|0.0001|TWO_SIDED|95.0|1.54|4.02||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - CBT-I) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - CBT-I) generated from the Mixed Model.|The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha.||4.02|1.54|<.0001
70915025|NCT00972504|141320777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-1.2|-0.1||||||||-0.1|-1.2|
70915026|NCT00972504|141320777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-1.8|-0.8||||||||-0.8|-1.8|
70915027|NCT00972504|141320777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-1.9|-0.8||||||||-0.8|-1.9|
70915028|NCT00972504|141320778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|0.0|0.3|||||Comparison of Nasal Blockage between Placebo and GSK1004723 1000 µg once daily.|||0.3|-0.0|
70915029|NCT00972504|141320778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.4|-0.1|||||Comparison of Nasal Blockage between Placebo and GSK835726 10 mg once daily.|||-0.1|-0.4|
70915030|NCT00972504|141320778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.4|-0.1|||||Comparison of Nasal Blockage between Placebo and Cetirizine 10 mg once daily.|||-0.1|-0.4|
70970702|NCT00531752|141447065|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5103|STANDARD_ERROR_OF_MEAN|0.1103|<|0.0001|TWO_SIDED|80.0|0.36707|0.65345|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.65345|0.36707|<0.0001
70915031|NCT00972504|141320778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.4|-0.1|||||Comparison of Rhinorrhoea between Placebo and GSK1004723 1000 µg once daily.|||-0.1|-0.4|
70915032|NCT00972504|141320778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.6|-0.2|||||Comparison of Rhinorrhoea between Placebo and GSK835726 10 mg once daily.|||-0.2|-0.6|
70915033|NCT00972504|141320778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.6|-0.3|||||Comparison of Rhinorrhoea between Placebo and Cetirizine 10 mg once daily.|||-0.3|-0.6|
70915034|NCT00972504|141320778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.4|-0.1|||||Comparison of Nasal Itching between Placebo and GSK1004723 1000 µg once daily.|||-0.1|-0.4|
70915035|NCT00972504|141320778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.5|-0.2|||||Comparison of Nasal Itching between Placebo and GSK835726 10 mg once daily.|||-0.2|-0.5|
70915036|NCT00972504|141320778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.5|-0.2|||||Comparison of Nasal Itching between Placebo and Cetirizine 10 mg once daily.|||-0.2|-0.5|
70915037|NCT00972504|141320778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|95.0|-0.5|-0.2|||||Comparison of Sneezing between Placebo and GSK1004723 1000 µg once daily.|||-0.2|-0.5|
70915038|NCT00972504|141320778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|95.0|-0.4|-0.2|||||Comparison of Sneezing between Placebo and GSK835726 10mg once daily.|||-0.2|-0.4|
70915039|NCT00972504|141320778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|95.0|-0.5|-0.2|||||Comparison of Sneezing between Placebo and Cetirizine 10mg once daily.|||-0.2|-0.5|
70915040|NCT00972504|141320779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.041|STANDARD_ERROR_OF_MEAN|0.4194|||TWO_SIDED|95.0|-1.87|-0.212||||||||-0.212|-1.870|
71092963|NCT00695019|141692625|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0023||95.0||||Analysis not adjusted to account for baseline differences between the groups.|Kruskal-Wallis|||||||0.0023
70915041|NCT00972504|141320779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.76|STANDARD_ERROR_OF_MEAN|0.4172|||TWO_SIDED|95.0|-2.584|-0.936||||||||-0.936|-2.584|
70915042|NCT00972504|141320779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.792|STANDARD_ERROR_OF_MEAN|0.4224|||TWO_SIDED|95.0|-3.626|-1.957||||||||-1.957|-3.626|
70915043|NCT00972504|141320780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.306|||TWO_SIDED|95.0|-0.28|0.93||||||||0.93|-0.28|
70915044|NCT00972504|141320780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.305|||TWO_SIDED|95.0|-1.65|-0.45||||||||-0.45|-1.65|
70915045|NCT00972504|141320780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|0.308||||95.0|-1.68|-0.46||||||||-0.46|-1.68|
70915046|NCT04246762|141320784|OTHER||geometric LS mean ratio of AUC (0-inf))|70.46|||||TWO_SIDED|90.0|60.62|81.91|||||Results based on a linear mixed model for the log-transformed values of PK parameters of midazolam with a fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (midazolam (as part of a 4-drug oral cocktail) after OKZ administration compared to midazolam (as part of a 4-drug oral cocktail) administrated alone) and its corresponding 90% confidence interval (CI) were calculated. The mean difference and the CI were back transformed to the original scale to obtain estimates of the geometric mean ratio and the associated 90% CI.||81.91|60.62|
70915047|NCT04246762|141320784|OTHER||geometric LS mean ratio of AUC (0-inf))|67.87|||||TWO_SIDED|90.0|56.73|81.21|||||Results based on a linear mixed model for the log-transformed values of PK parameters of omeprazole with a fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (omeprazole (as part of a 4-drug oral cocktail) after OKZ administration compared to omeprazole (as part of a 4-drug oral cocktail) administrated alone) and its corresponding 90% confidence interval (CI) were calculated. The mean difference and the CI were back transformed to the original scale to obtain estimates of the geometric mean ratio and the associated 90% CI.||81.21|56.73|
70915048|NCT04246762|141320784|OTHER||geometric LS mean ratio of AUC (0-inf))|122.92|||||TWO_SIDED|90.0|107.98|139.93|||||Results based on a linear mixed model for the log-transformed values of baseline-adjusted PK parameters of caffeine with a with fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (caffeine (as part of a 4-drug oral cocktail) after OKZ administration compared to caffeine (as part of a 4-drug oral cocktail) administrated alone) and its corresponding 90% confidence interval (CI) were calculated. The mean difference and the CI were back transformed to the original scale to obtain estimates of the geometric mean ratio and the associated 90% CI.||139.93|107.98|
70915049|NCT04246762|141320785|OTHER||geometric LS mean ratio of AUC (0-last))|90.83|||||TWO_SIDED|90.0|86.72|95.13|||||Results based on a linear mixed model for the log-transformed values of PK parameters of S-warfarin with a fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (S-warfarin (as part of a 4-drug oral cocktail) after OKZ administration compared to initial S-warfarin administrated alone (as part of a 4-drug oral cocktail)) and its corresponding 90% confidence interval (CI) was calculated. The mean difference and the CI were back transformed to the original scale to obtain estimate of the geometric mean ratio and the associated 90% CI.||95.13|86.72|
70915050|NCT04246762|141320786|OTHER||geometric LS mean ratio of Cmax|68.5|||||TWO_SIDED|90.0|59.46|78.92|||||Results based on a linear mixed model for the log-transformed values of PK parameters of midazolam with a fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (midazolam (as part of a 4-drug oral cocktail) after OKZ administration compared to midazolam (as part of a 4-drug oral cocktail) administrated alone) and its corresponding 90% confidence interval (CI) were calculated. The mean difference and the CI were back transformed to the original scale to obtain estimates of the geometric mean ratio and the associated 90% CI.||78.92|59.46|
70915051|NCT04246762|141320786|OTHER||geometric LS mean ratio of Cmax|73.54|||||TWO_SIDED|90.0|64.18|84.27|||||Results based on a linear mixed model for the log-transformed values of PK parameters of omeprazole with a fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (omeprazole (as part of a 4-drug oral cocktail) after OKZ administration compared to omeprazole (as part of a 4-drug oral cocktail) administrated alone) and its corresponding 90% confidence interval (CI) were calculated. The mean difference and the CI were back transformed to the original scale to obtain estimates of the geometric mean ratio and the associated 90% CI.||84.27|64.18|
70915052|NCT04246762|141320786|OTHER||geometric LS mean ratio of Cmax|97.99|||||TWO_SIDED|90.0|91.36|105.09|||||Results based on a linear mixed model for the log-transformed values of baseline-adjusted PK parameters of caffeine with a with fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (caffeine (as part of a 4-drug oral cocktail) after OKZ administration compared to caffeine (as part of a 4-drug oral cocktail) administrated alone) and its corresponding 90% confidence interval (CI) were calculated. The mean difference and the CI were back transformed to the original scale to obtain estimates of the geometric mean ratio and the associated 90% CI.||105.09|91.36|
70970703|NCT00531752|141447065|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3643|STANDARD_ERROR_OF_MEAN|0.1174||0.0031|TWO_SIDED|80.0|0.21189|0.51664|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.51664|0.21189|0.0031
70970704|NCT00531752|141447065|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1362|STANDARD_ERROR_OF_MEAN|0.09408||0.1553|TWO_SIDED|80.0|0.01366|0.25882|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.25882|0.01366|0.1553
70970705|NCT00531752|141447065|SUPERIORITY_OR_OTHER||LS Mean Difference|0.107|STANDARD_ERROR_OF_MEAN|0.09797||0.2809|TWO_SIDED|80.0|-0.0205|0.23458|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.23458|-0.0205|0.2809
70970706|NCT00531752|141447065|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2195|STANDARD_ERROR_OF_MEAN|0.1146||0.0603|TWO_SIDED|80.0|0.07101|0.36803|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.36803|0.07101|0.0603
70915053|NCT04246762|141320786|OTHER||geometric LS mean ratio of Cmax|102.3|||||TWO_SIDED|90.0|94.8|110.39|||||Results based on a linear mixed model for the log-transformed values of PK parameters of S-warfarin with a fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (S-warfarin (as part of a 4-drug oral cocktail) after OKZ administration compared to initial S-warfarin administrated alone (as part of a 4-drug oral cocktail)) and its corresponding 90% confidence interval (CI) was calculated. The mean difference and the CI were back transformed to the original scale to obtain estimate of the geometric mean ratio and the associated 90% CI. The sample size computation was based on results reported for sirukumab.||110.39|94.80|
70915054|NCT04495634|141320814|EQUIVALENCE|The equivalence margin was defined through power calculations based on sample size, power of 0.90 and alpha of 0.05 resulting in a margin of +/- 0.26.|||||<|0.0001|||||||ANOVA|||||||<0.0001
70915055|NCT04495634|141320815|EQUIVALENCE|The equivalence margin was defined through power calculations based on sample size, power of 0.90 and alpha of 0.05 resulting in a margin of +/- 0.26.||||||0.41|||||||ANOVA|||||||0.41
70915056|NCT04495634|141320816|EQUIVALENCE|The equivalence margin was defined through power calculations based on sample size, power of 0.90 and alpha of 0.05 resulting in a margin of +/- 0.26.||||||0.0001|||||||ANOVA|||||||0.0001
70915057|NCT04495634|141320817|EQUIVALENCE|The equivalence margin was defined through power calculations based on sample size, power of 0.90 and alpha of 0.05 resulting in a margin of +/- 0.26.||||||0.0001|||||||ANOVA|||||||0.0001
70915058|NCT00768651|141320825|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||The sample size of 8 was determined to provide a 95% confidence interval expected width of 0.62 for the proportion of subjects who become insulin independent with treatment. Four of eight subjects (50%) would have to achieve insulin independence in order to reject the null hypothesis with 85% power and one sided alpha of 0.025. Statistical significance was set at 5%. Mean values were computed using Student's t-test while medians were compared using Wilcoxon's test.||||< 0.05
70915059|NCT02124460|141320850|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.3928|TWO_SIDED|95.0|-0.08|0.03|||Linear repeated measures|Multiple imputation was used for missing follow-up data.|Health Coaching group compared to Enhanced Primary Care|||0.03|-0.08|0.3928
70915060|NCT02124460|141320851|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.89||||0.2306|TWO_SIDED|95.0|-0.56|2.33|||Linear repeated measures|Multiple imputation used for missing data at follow-up|Health Coaching group compared to Enhanced Primary Care|||2.33|-0.56|0.2306
70915061|NCT02124460|141320852|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.14|TWO_SIDED|95.0|-0.02|0.16|||Linear repeated measures|Multiple imputation used for missing data at follow-up|Health Coaching group compared to Enhanced Primary Care.|||0.16|-0.02|.14
70915062|NCT02124460|141320853|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.0016|TWO_SIDED|95.0|-0.81|-0.19|||Linear repeated measures|Multiple imputation used for missing data at follow-up.||||-0.19|-0.81|0.0016
70915063|NCT02124460|141320854|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.42|||<|0.0001|TWO_SIDED|95.0|0.22|0.62||Multiple imputation used for missing data at follow-up.|Linear repeated measures|||||0.62|0.22|<.0001
70915064|NCT02124460|141320855|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18||||0.3043|TWO_SIDED|95.0|-0.16|0.53|||Linear repeated measures|Multiple imputation used for missing data at follow-up.||||0.53|-0.16|0.3043
70915065|NCT02124460|141320856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32||||0.0113|TWO_SIDED|95.0|0.07|0.56|||Linear repeated measures|Multiple imputation used for missing data at follow-up.||||0.56|0.07|0.0113
70915066|NCT02124460|141320857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21||||0.0792|TWO_SIDED|95.0|-0.45|0.03|||Linear repeated measures|Multiple imputation used for missing data at follow-up.||||0.03|-0.45|0.0792
70915067|NCT00392678|141320885|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
70915068|NCT03008915|141320892|OTHER|Paired t-test for participants with measures on both aspirin and placebo.||||||0.692|||||||t-test, 2 sided|||The null hypothesis is that there is no difference between measures on aspirin and placebo.||||0.692
70915069|NCT00712166|141320899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.433|TWO_SIDED|95.0|-2.83|6.44||"The primary endpoint analysis was based on a two-sided test with an 0.05 a priori threshold for statistical significance.~A gate-keeper approach was established a priori to control the type 1 error rate, however, the primary endpoint was not met."|ANCOVA|ANCOVA included: treatment, baseline CFQ-R RSS, age group (\<18, \>=18 years). Denominator degrees of freedom computed with Satterthwaite approximation.||"Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in CFQ-R RSS score at Day 28.~At the 5% significance level (i.e., α = 0.05) using a two-sided significance test, a sample size of 70 participants per treatment group provided at least 90% power to detect a 10 point difference between groups in the mean change from baseline at Day 28 in the CFQ-R RSS score, assuming a common standard deviation (SD) of 17.5."||6.44|-2.83|0.433
70970707|NCT00531752|141447065|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4278|STANDARD_ERROR_OF_MEAN|0.1212||0.0008|TWO_SIDED|80.0|0.27079|0.58479|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.58479|0.27079|0.0008
70970708|NCT00531752|141447066|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.3264|STANDARD_ERROR_OF_MEAN|2.6944|<|0.0001|TWO_SIDED|80.0|-16.83|-9.828|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-9.828|-16.83|<0.0001
70970709|NCT00531752|141447066|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.126|STANDARD_ERROR_OF_MEAN|2.8841||0.0068|TWO_SIDED|80.0|-11.87|-4.382|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-4.382|-11.87|0.0068
70970710|NCT00531752|141447066|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.5341|STANDARD_ERROR_OF_MEAN|2.3172||0.1346|TWO_SIDED|80.0|-6.551|-0.5175|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.5175|-6.551|0.1346
70970711|NCT00531752|141447066|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0911|STANDARD_ERROR_OF_MEAN|2.4268||0.6552|TWO_SIDED|80.0|-2.067|4.2494|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.2494|-2.067|0.6552
70915070|NCT00712166|141320900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.37||||0.133|TWO_SIDED|95.0|-1.04|7.78||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA included terms: treatment, baseline CFQ-R RSS, age group (\<18, \>=18 years). Treatment differences were calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in the CFQ-R RSS score at Day 14.||7.78|-1.04|0.133
70915071|NCT00712166|141320901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.965|TWO_SIDED|95.0|-4.56|4.76||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included terms for treatment, baseline CFQ-R RSS and age group (\<18 years, \>=18 years). Treatment differences calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in the CFQ-R RSS score at Day 42.||4.76|-4.56|0.965
70915072|NCT00712166|141320902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.47||||0.256||95.0|-1.81|6.76||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA included: treatment, baseline CFQ-R Physical Function Domain score and age (\<18, \>=18 years). Treatment differences calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in the CFQ-R physical functioning domain score at Day 28.||6.76|-1.81|0.256
70915073|NCT00712166|141320903|SUPERIORITY_OR_OTHER||||||>|0.999||0.0||||No adjustments were made for multiple comparisons.|Fisher Exact|A participant with multiple usage was counted only once.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in number of participants using additional (nonprotocol-specified) antipseudomonal antibiotics during study.||||>0.999
70915074|NCT00712166|141320904|SUPERIORITY_OR_OTHER|||||||0.122||||||No adjustments were made for multiple comparisons.|Fisher Exact|A participant with multiple hospitalizations was counted only once.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in proportion of participants hospitalized.||||0.122
70915075|NCT00712166|141320907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.016|TWO_SIDED|95.0|-2.2|-0.23||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, baseline log10 CFU, and age group (\<18, \>=18 years). Treatment differences were calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in the log10 CFU at Day 28.||-0.23|-2.20|0.016
70915076|NCT00712166|141320908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.73||||0.021|TWO_SIDED|95.0|0.42|5.04||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model includes treatment, baseline FEV1 % predicted, and age group (\<18, \>=18 years). Treatment differences were calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in % change from baseline in FEV1 % predicted at Day 28.||5.04|0.42|0.021
70915077|NCT01264718|141320914|OTHER|The Intervention Cost-Effectiveness Ratio (ICER) is the difference in total costs between the intervention group and controls was divided by the intergroup difference in the proportion of insured children.|ICER|6.0|||||TWO_SIDED||||||||The estimated value is the savings per child per year insured.|||||
70915078|NCT01264718|141320914|OTHER|The Intervention Cost-Effectiveness Ratio (ICER) is the difference in total costs between the intervention group and controls was divided by the intergroup difference in the proportion of insured children.|ICER|4.0|||||TWO_SIDED||||||||The estimated value is the savings for each percent increase in children obtaining insurance per year.|||||
70915079|NCT01144182|141320936|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED|||||For this pilot study, significance level was set at p\<0.05|Wilcoxon (Mann-Whitney)|||||||.56
70915080|NCT01144182|141320937|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.22
70915081|NCT01144182|141320938|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.05
70915082|NCT01144182|141320939|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.34
70915083|NCT01144182|141320940|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.008
71092964|NCT00695019|141692626|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21||95.0|||||Kruskal-Wallis|||Fibrotest provides an estimate of liver fibrosis based on the values of 5 serum markers. Scores range from 0 to 1 with higher scores indicating a greater level of liver fibrosis. A negative change in Fibrotest score is therefore deemed to indicate improvement (reduction in fibrosis), while a positive change indicates worsening condition.||||0.21
70915084|NCT01144182|141320941|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.30
70915085|NCT01144182|141320942|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.15
70915086|NCT01144182|141320943|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.55
70915087|NCT01144182|141320944|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.56
70915088|NCT01144182|141320945|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.05
70915089|NCT01144182|141320946|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.15
70915090|NCT01144182|141320947|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.26
70915091|NCT01144182|141320948|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.36
70915092|NCT03772964|141320950|SUPERIORITY|Comparisons between samples and sample groups (beta-diversity), were evaluated with ADONIS (aka PERMANOVA) comparisons of differences between sample groups.|R2|0.071435|||<|0.01|TWO_SIDED||||||ADONISBeta Diversity|Comparisons between samples and sample groups (beta-diversity) were evaluated with ADONIS (aka PERMANOVA)|R2 values estimate the amount of variation explained by each variable.|Beta Diversity - Differences between Samples and Sample groups||||<0.01
70915093|NCT03772964|141320951|SUPERIORITY|||||||0.6057|||||||ANOVA|||||||0.6057
70915094|NCT03772964|141320953|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
70915095|NCT03772964|141320954|SUPERIORITY|||||||0.69|||||||ANOVA|||||||0.69
71092965|NCT00695019|141692627|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0|||||Chi-squared|||||||0.03
71092966|NCT00695019|141692627|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0|||||Chi-squared|||||||0.005
71092967|NCT05845619|141692705|SUPERIORITY|There was no power calculation because this was a pilot study.|Odds Ratio (OR)|1.21||||0.33|TWO_SIDED|95.0|0.83|1.76|||Regression, Logistic||Numerator: pilot; denominator: prospective controls|In this pilot study, we hypothesized that pilot participants would have a reduced risk of viremia 6 months after the intervention compared to controls.||1.76|0.83|0.33
71092968|NCT05845619|141692705|SUPERIORITY|No power calculation, pilot study.|Odds Ratio (OR)|1.25||||0.41|TWO_SIDED|95.0|0.73|2.14|||Regression, Logistic|||||2.14|0.73|0.41
71092969|NCT04153864|141692736|NON_INFERIORITY|The Non-Inferiority Margin (NIM) was defined as 10% of the mean EPDS score in the Specialist group (8.91), which corresponded to a value of 0.89. This predetermined NIM of 10% aligns with noninferiority guidelines and ensures clinically meaningful conclusions.|Mean Difference (Final Values)|0.36|||<|0.05|ONE_SIDED|95.0||0.86|||t-test, 1 sided|||Behavioral Activation (BA) delivered by Non-Specialists will be non-inferior to BA delivered by Specialists if the upper limit of the 95% confidence interval for the estimated mean difference in EPDS scores is less than the pre-specified 10% non-inferiority margin (NIM).||0.86||<0.05
70915096|NCT03538054|141320962|SUPERIORITY||Slope|-5.065||||0.146|TWO_SIDED|||||The clinical threshold was p \< 0.05, with no corrections for multiple comparisons.|GEE|Outcome scores were mean-centered by participant, allowing analyses to reflect within-person changes rather than between-person differences.||||||0.146
70915097|NCT03538054|141320963|SUPERIORITY||Slope|4.221||||0.052|TWO_SIDED|||||The clinical threshold was p \< 0.05, with no corrections for multiple comparisons.|GEE|Outcome scores were mean-centered by participant, allowing analyses to reflect within-person changes rather than between-person differences.||||||0.052
70915098|NCT03254394|141320965|SUPERIORITY||Mean Difference (Final Values)|6.88||||0.318|TWO_SIDED|95.0|-7.09|20.85||p-value was not adjusted for any parameter.|t-test, 2 sided|||Null hypothesis: Average AUC of cold pain score over 14 days of a chemotherapy cycle in the Control group is equal or lower than that of the experimental group. The comparison is for average AUC values over 7 cycles of chemotherapy per patient||20.85|-7.09|0.318
70915099|NCT03254394|141320965|SUPERIORITY||Mean Difference (Final Values)|7.67||||0.466|TWO_SIDED|95.0|-13.76|29.1||p-value was not adjusted for any parameter.|t-test, 2 sided|||Null hypothesis: Cold hypersensitivity counted as unpleasantness score for 14 days after cycle (AUC) in the Control group is less than that of the experimental group. The difference was calculated for the Cycle 6 visit.||29.10|-13.76|0.466
70915100|NCT03254394|141320966|SUPERIORITY||Median Difference (Final Values)|20.0||||0.338|TWO_SIDED|||||p-value was not adjusted for any parameter.|Wilcoxon (Mann-Whitney)|||the null hypothesis is EORTC QLQ-CIPN20 sensory score change in the Control group is equal to or less than that of the experimental group for the last follow-up study visit.||||0.338
70915101|NCT03254394|141320966|SUPERIORITY||Median Difference (Final Values)|2.0||||0.759|TWO_SIDED|||||p-value was not adjusted for any parameter.|Wilcoxon (Mann-Whitney)|||The null hypothesis is EORTC QLQ-CIPN20 sensory score change in the Control group is equal to or less than that of the experimental group for the cycle 6 (12 weeks) follow-up study visit.||||0.759
70915102|NCT03254394|141320967|SUPERIORITY||Median Difference (Final Values)|0.0||||0.581|TWO_SIDED|||||p-value was not adjusted for any parameter.|Wilcoxon (Mann-Whitney)|||The null hypothesis is NPSI total score in the Control group is equal to or less than that of the experimental group for the C3 (6 weeks) study visit.||||0.581
70915103|NCT03254394|141320967|SUPERIORITY||Median Difference (Final Values)|0.0||||0.962|TWO_SIDED|||||p-value was not adjusted for any parameter.|Wilcoxon (Mann-Whitney)|||The null hypothesis is NPSI total score in the Control group is equal to or less than that of the experimental group for the C6 (12 weeks) study visit.||||0.962
70915104|NCT03254394|141320967|SUPERIORITY||Median Difference (Final Values)|10.5||||0.365|TWO_SIDED|||||p-value was not adjusted for any parameter.|Wilcoxon (Mann-Whitney)|||The null hypothesis is NPSI total score in the Control group is equal to or less than that of the experimental group for the last follow-up study visit.||||0.365
70915105|NCT03254394|141320968|SUPERIORITY||Mean Difference (Final Values)|57.68||||0.73|TWO_SIDED|95.0|-1771.0|1886.0|||t-test, 2 sided|||The null hypothesis is Oxaliplatin cumulative dose in the Control group is equal to or higher than that of the experimental group.||1886|-1771|0.730
70915106|NCT03360396|141320969|OTHER|Study was closed early in all regions except for France. Statistical Analysis plan was updated to include descriptive statistics only. Sites in France remain open and all subjects in France will be followed through 36 months.||||||||||||Study was closed early in all regions except for France. Statistical Analysis plan was updated to include descriptive statistics only. Sites in France remain open and all subjects in France will be followed through 36 months.||Study was closed early in all regions except for France. SAP was updated to include descriptive statistics only. French sites remain open.||Study was closed early in all regions except for France. Statistical Analysis plan was updated to include descriptive statistics only. Sites in France remain open and all subjects in France will be followed through 36 months.|Study was closed early in all regions except for France. Statistical Analysis plan was updated to include descriptive statistics only. Sites in France remain open and all subjects in France will be followed through 36 months.|||
70915107|NCT03360396|141320970|OTHER|Study was terminated early, and Statistical Analysis plan was updated to include descriptive statistics only.||||||||||||Study was terminated early, and Statistical Analysis plan was updated to include descriptive statistics only.||Study was terminated early, and Statistical Analysis plan was updated to include descriptive statistics only.||Study was terminated early, and Statistical Analysis plan was updated to include descriptive statistics only.|Study was terminated early, and Statistical Analysis plan was updated to include descriptive statistics only.|||
70915108|NCT01867580|141321000|SUPERIORITY|||||||0.677|||||||Regression, Logistic|||||||0.6770
70915109|NCT01867580|141321001|SUPERIORITY|||||||0.0202|||||||Wilcoxon (Mann-Whitney)|||||||0.0202
70915110|NCT01867580|141321002|SUPERIORITY|||||||0.0142|||||||Regression, Logistic|||||||0.0142
70915111|NCT03425643|141321006|SUPERIORITY||Hazard Ratio (HR)|0.59|||<|1e-05|TWO_SIDED|95.0|0.48|0.72||One-sided p-value based on log-rank test stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|Log Rank||Stratified Cox model with Efron's tie handling method with treatment as a covariate stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|||0.72|0.48|<0.00001
70970712|NCT00531752|141447066|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.2001|STANDARD_ERROR_OF_MEAN|1.7614||0.0765|TWO_SIDED|80.0|-5.494|-0.9063|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.9063|-5.494|0.0765
71153907|NCT00488683|141800059|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.2||||0.1||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination||||0.10
70915112|NCT03425643|141321007|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.00517|TWO_SIDED|95.0|0.56|0.93||One-sided p-value based on log-rank test stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|Log Rank||Stratified Cox model with Efron's tie handling method with treatment as a covariate stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|||0.93|0.56|0.00517
70915113|NCT03425643|141321008|OTHER|Based on Miettinen \& Nurminen method stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|Difference in Percentage|19.2|||<|1e-05|TWO_SIDED|95.0|13.9|24.7|||Stratified Miettinen and Nurminen|||||24.7|13.9|<0.00001
70915114|NCT03425643|141321009|OTHER|Based on Miettinen \& Nurminen method stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|Difference in Pertentage|14.2|||<|1e-05|TWO_SIDED|95.0|10.1|18.7|||Stratified Miettinen and Nurminen|||||18.7|10.1|<0.00001
70915115|NCT03425643|141321010|OTHER|Based on a constrained longitudinal data analysis (cLDA) model with the scores as the response variable with covariates for treatment by visit interaction and stratification factors (Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|Difference in Least Square Means|1.43||||0.3611|TWO_SIDED|95.0|-1.64|4.49|||t-test, 2 sided|||||4.49|-1.64|0.3611
70915116|NCT03425643|141321011|OTHER|Based on a constrained longitudinal data analysis (cLDA) model with the scores as the response variable with covariates for treatment by visit interaction and stratification factors (Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|Difference in Least Square Means|2.22||||0.1197|TWO_SIDED|95.0|-0.58|5.02|||t-test, 2 sided|||||5.02|-0.58|0.1197
70915117|NCT03224299|141321066|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.44|0.69||||||"Abdomen 10 minutes~Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||0.69|-0.44|
70915118|NCT03224299|141321066|SUPERIORITY||Mean Difference (Final Values)|1.93|||||TWO_SIDED|95.0|1.36|2.49||||||Abdomen 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.49|1.36|
70915119|NCT03224299|141321066|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.18|||||TWO_SIDED|95.0|-0.73|0.36||||||Abdomen 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.36|-0.73|
70915120|NCT03224299|141321066|SUPERIORITY||Mean Difference (Final Values)|2.23|||||TWO_SIDED|95.0|1.69|2.78||||||Abdomen 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.78|1.69|
70915121|NCT03224299|141321066|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-0.9|0.31||||||Groin 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.31|-0.90|
70915122|NCT03224299|141321066|SUPERIORITY||Mean Difference (Final Values)|2.6|||||TWO_SIDED|95.0|1.98|3.22||||||Groin 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||3.22|1.98|
70915123|NCT03224299|141321066|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.61|0.57||||||Groin 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.57|-0.61|
70915124|NCT03224299|141321066|SUPERIORITY||Mean Difference (Final Values)|2.33|||||TWO_SIDED|95.0|1.72|2.93||||||Groin 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.93|1.72|
70915125|NCT03224299|141321066|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.35|||||TWO_SIDED|95.0|-0.91|0.22||||||Abdomen 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.22|-0.91|
70915126|NCT03224299|141321066|SUPERIORITY||Mean Difference (Final Values)|2.45|||||TWO_SIDED|95.0|1.88|3.01||||||Abdomen 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||3.01|1.88|
70915127|NCT03224299|141321066|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.31|||||TWO_SIDED|95.0|-0.85|0.24||||||Abdomen 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.24|-0.85|
70915128|NCT03224299|141321066|SUPERIORITY||Mean Difference (Final Values)|2.41|||||TWO_SIDED|95.0|1.87|2.95||||||Abdomen 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.95|1.87|
70915129|NCT03224299|141321066|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.14|||||TWO_SIDED|95.0|-0.67|0.4||||||Groin 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.40|-0.67|
70915130|NCT03224299|141321066|SUPERIORITY||Mean Difference (Final Values)|2.25|||||TWO_SIDED|95.0|1.7|2.8||||||Groin 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.80|1.70|
70915131|NCT03224299|141321066|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.56|0.48||||||Groin 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.48|-0.56|
70915132|NCT03224299|141321066|SUPERIORITY||Mean Difference (Final Values)|2.15|||||TWO_SIDED|95.0|1.62|2.68||||||Groin 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.68|1.62|
70915133|NCT00959920|141321074|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.8||||0.42|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis is that patients for whom indwelling foley catheterization was employed will have their time to delivery interval reduced by 30 minutes.||||.42
70915134|NCT02628093|141321076|OTHER|Because this was a pilot (exploratory) randomized study, no formal sample size calculation was required.||||||0.214||||||P value threshold \<0.05|Wilcoxon (Mann-Whitney)|||Because this was a pilot (exploratory) randomized study, no formal sample size calculation was required. Demographic, preoperative, and postoperative variables and the primary outcome were compared between groups (THUNDERBEAT and LigaSure) by the Wilcoxon rank-sum test for continuous variables and the chi-square test/Fisher's exact test for categorical variables, as appropriate. All p-values are two-sided with statistical significance evaluated at the 0.05 alpha level.||||0.214
70915135|NCT02628093|141321077|OTHER|||||||0.007||||||P value threshold \<0.05|Wilcoxon (Mann-Whitney)|||compared between groups by the Wilcoxon rank-sum test||||0.007
70915136|NCT02628093|141321081|OTHER|||||||1||||||P value threshold \<0.05|Fisher Exact|||||||1.0
70915137|NCT02715258|141321100|SUPERIORITY||mixed-effects repeated measures|-0.41||||0.0012|TWO_SIDED|95.0|-0.66|-0.16||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|Mixed Models Analysis|||Analysis of change from baseline in HbA1c (%) at Week 24||-0.16|-0.66|0.0012
70915138|NCT02715258|141321100|SUPERIORITY||mixed-effects repeated measures|-0.41||||0.0021|TWO_SIDED|95.0|-0.68|-0.15||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 1: Multiple imputation for change from baseline in HbA1c (%) including observations obtained after rescue medication||-0.15|-0.68|0.0021
70915139|NCT02715258|141321100|SUPERIORITY||mixed-effects repeated measures|-0.55|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.3||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|Mixed Models Analysis|||Sensitivity Analysis 2: Multiple imputation for change from baseline in HbA1c (%) excluding observations obtained after rescue medication||-0.30|-0.80|<0.0001
70915140|NCT02715258|141321100|SUPERIORITY||mixed-effects repeated measures|-0.4||||0.0009|TWO_SIDED|95.0|-0.64|-0.17||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 3: LOCF for change from baseline in HbA1c (%) including observations obtained after rescue medication||-0.17|-0.64|0.0009
70915141|NCT02715258|141321101|SUPERIORITY||mixed-effects repeated measures|-2.14||||0.234|TWO_SIDED|95.0|-5.66|1.39||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Analysis of change from baseline in SBP (mm Hg) at Week 24||1.39|-5.66|0.2340
70970713|NCT00531752|141447066|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.8781|STANDARD_ERROR_OF_MEAN|1.8976||0.0473|TWO_SIDED|80.0|-6.349|-1.407|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.407|-6.349|0.0473
70970714|NCT03152019|141447116|SUPERIORITY||percentages|0.77|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
70970715|NCT00609791|141447158|SUPERIORITY||Slope|0.011|STANDARD_ERROR_OF_MEAN|0.0057||0.055|TWO_SIDED||||||Regression, Linear|||Linear regression of ln AUC24 on age in years||||0.055
70970716|NCT00609791|141447158|SUPERIORITY||Slope|1.17|STANDARD_ERROR_OF_MEAN|0.45||0.013|TWO_SIDED||||||Regression, Linear|||Linear regression of ln AUC24 on chemotherapy toxicity risk score||||0.013
71153908|NCT00488683|141800059|SUPERIORITY_OR_OTHER||R-square|0.06||||||95.0|||||Regression, Linear|||Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination||||
70915142|NCT02715258|141321101|SUPERIORITY||mixed-effects repeated measures|-1.91||||0.2937|TWO_SIDED|95.0|-5.48|1.66||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 1: Multiple imputation for change from baseline in SBP (mm Hg) including observations obtained after rescue medication||1.66|-5.48|0.2937
70915143|NCT02715258|141321101|SUPERIORITY||mixed-effects repeated measures|-1.72||||0.403|TWO_SIDED|95.0|-5.75|2.32||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 2: Multiple imputation for change from baseline in SBP (mm Hg) excluding observations obtained after rescue medication||2.32|-5.75|0.4030
70915144|NCT02715258|141321101|SUPERIORITY||mixed-effects repeated measures|-2.09||||0.216|TWO_SIDED|95.0|-5.41|1.23||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||||1.23|-5.41|0.2160
70915145|NCT02715258|141321102|SUPERIORITY||mixed-effects repeated measures|-0.79||||0.1222|TWO_SIDED|95.0|-1.8|0.21||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Analysis of change from baseline in body weight (kg) at Week 24 for subjects with BMI greater than or equal to 25 kg/m2||0.21|-1.80|0.1222
70915146|NCT02715258|141321102|SUPERIORITY||mixed-effects repeated measures|-0.65||||0.2014|TWO_SIDED|95.0|-1.65|0.35||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 1: Multiple imputation for change from baseline in body weight (kg) for subjects with BMI greater than or equal to 25 kg/m2 including observations obtained after rescue medication||0.35|-1.65|0.2014
70915147|NCT02715258|141321102|SUPERIORITY||mixed-effects repeated measures|-0.91||||0.0638|TWO_SIDED|95.0|-1.88|0.05||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 2: Multiple imputation for change from baseline in body weight (kg) for subjects with BMI greater than or equal to 25 kg/m2 excluding observations obtained after rescue medication||0.05|-1.88|0.0638
70915148|NCT02715258|141321102|SUPERIORITY||mixed-effects repeated measures|-0.69||||0.1456|TWO_SIDED|95.0|-1.63|0.24||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 3: LOCF for change from baseline in body weight (kg) for subjects with BMI greater than or equal to 25 kg/m2 including observations obtained after rescue medication||0.24|-1.63|0.1456
70915149|NCT02715258|141321103|SUPERIORITY||mixed-effects repeated measures|-1.5|||<|0.0001|TWO_SIDED|95.0|-1.92|-1.09||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Analysis of change from baseline in FPG (mmol/L) over time across 24 weeks||-1.09|-1.92|<0.0001
70915150|NCT02715258|141321104|SUPERIORITY||mixed-effects repeated measures|-0.61|||<|0.0001|TWO_SIDED|95.0|-0.79|-0.43||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Change from baseline in HbA1c (%) at Week 6||-0.43|-0.79|<0.0001
70915151|NCT02715258|141321104|SUPERIORITY||mixed-effects repeated measures|-0.71|||<|0.0001|TWO_SIDED|95.0|-0.92|-0.5||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Change from baseline in HbA1c (%) at Week 12||-0.50|-0.92|<0.0001
70970717|NCT00609791|141447159|SUPERIORITY||Slope|-0.0074|STANDARD_ERROR_OF_MEAN|0.0063||0.25|TWO_SIDED||||||Regression, Linear|||Linear regression of ln CL on age in years||||0.25
70915152|NCT02715258|141321104|SUPERIORITY||mixed-effects repeated measures|-0.57|||<|0.0001|TWO_SIDED|95.0|-0.78|-0.36||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Change from baseline in HbA1c (%) at Week 18||-0.36|-0.78|<0.0001
70915153|NCT02715258|141321104|SUPERIORITY||mixed-effects repeated measures|-0.41||||0.0012|TWO_SIDED|95.0|-0.66|-0.16||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Change from baseline in HbA1c (%) at Week 24||-0.16|-0.66|0.0012
70915154|NCT02715258|141321104|SUPERIORITY||mixed-effects repeated measures|-0.58|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.39||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Change from baseline in HbA1c (%) across 24 weeks||-0.39|-0.76|<0.0001
70970718|NCT00609791|141447159|SUPERIORITY||Slope|-0.96|STANDARD_ERROR_OF_MEAN|0.44||0.04|TWO_SIDED||||||Regression, Linear|||Linear regression of ln CL versus chemotherapy toxicity risk score||||0.04
70970719|NCT00609791|141447160|OTHER|||||||0.041|||||||Fisher Exact|||||||0.041
70970720|NCT00609791|141447163|SUPERIORITY||Mean Difference (Final Values)|-4.89||||0.38|TWO_SIDED|95.0|-16.5|6.7|||t-test, 2 sided|||Difference in age based on whether there was need for a dose reduction.||6.7|-16.5|.38
70970721|NCT00609791|141447163|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.76|TWO_SIDED|95.0|-0.33|0.44|||t-test, 2 sided|||Difference in AUC24 based on the need of a dose reduction.||0.44|-0.33|0.76
70970722|NCT00609791|141447163|SUPERIORITY||Mean Difference (Final Values)|-0.063||||0.75|TWO_SIDED|95.0|-0.49|0.36|||t-test, 2 sided|||Difference in clearance based on whether there was a need for dose reduction.||0.36|-0.49|0.75
70915155|NCT02715258|141321105|SUPERIORITY||Odds Ratio (OR)|3.39||||0.0006|TWO_SIDED|95.0|1.69|6.8||The logistic regression includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Model-Adjusted proportion of subjects with HbA1c \<7% across 24 weeks||6.80|1.69|0.0006
70915156|NCT02814643|141321106|OTHER||Geometric least-square mean ratio|0.87|||||TWO_SIDED|90.0|0.56|1.35|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza A H1N1||1.35|0.56|
70915157|NCT02814643|141321106|OTHER||Geometric least-square mean ratio|1.19|||||TWO_SIDED|90.0|0.82|1.71|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza A H3N2||1.71|0.82|
70915158|NCT02814643|141321106|OTHER||Geometric least-square mean ratio|0.93|||||TWO_SIDED|90.0|0.67|1.29|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza B Yamagata lineage||1.29|0.67|
70915159|NCT02814643|141321106|OTHER||Geometric least-square mean ratio|0.8|||||TWO_SIDED|90.0|0.54|1.19|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza B Victoria lineage||1.19|0.54|
70915160|NCT02814643|141321107|OTHER||Geometric least-square mean ratio|1.0|||||TWO_SIDED|90.0|0.76|1.31|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza A H1N1||1.31|0.76|
70915161|NCT02814643|141321107|OTHER||Geometric least-square mean ratio|1.28|||||TWO_SIDED|90.0|0.93|1.77|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza A H3N2||1.77|0.93|
70915162|NCT02814643|141321107|OTHER||Geometric least-square mean ratio|1.03||||||90.0|0.79|1.34|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza B Yamagata lineage||1.34|0.79|
70915163|NCT02814643|141321107|OTHER||Geometric least-square mean ratio|1.26||||||90.0|0.93|1.7|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza B Victoria lineage||1.70|0.93|
70915164|NCT02263508|141321116|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.13|TWO_SIDED|95.0|0.71|1.04|||Stratified log-rank test|Stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|Cox proportional hazards model stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|||1.04|0.71|0.13
70915165|NCT02263508|141321117|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.77|TWO_SIDED|95.0|0.77|1.21|||Stratified log-rank test|Stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|Cox proportional hazards model stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|||1.21|0.77|0.77
70915166|NCT02263508|141321125|OTHER||Odds Ratio (OR)|1.88||||0.012|TWO_SIDED|95.0|1.15|3.07|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||3.07|1.15|0.012
70915167|NCT02263508|141321126|OTHER||Hazard Ratio (HR)|1.05||||0.14|TWO_SIDED|95.0|0.82|1.34|||Stratified log-rank test|Stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|Cox proportional hazards model stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|||1.34|0.82|0.14
70915168|NCT02263508|141321127|OTHER||Hazard Ratio (HR)|0.88||||0.47|TWO_SIDED|95.0|0.63|1.24|||Stratified log-rank test|Stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|Cox proportional hazards model stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|||1.24|0.63|0.47
70915169|NCT02263508|141321128|OTHER||Odds Ratio (OR)|1.32||||0.081|TWO_SIDED|95.0|0.97|1.79|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||1.79|0.97|0.081
70915170|NCT02263508|141321130|OTHER||Odds Ratio (OR)|1.39||||0.039|TWO_SIDED|95.0|1.02|1.9|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||1.90|1.02|0.039
70915171|NCT02263508|141321132|OTHER||Odds Ratio (OR)|1.28||||0.11|TWO_SIDED|95.0|0.94|1.75|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||1.75|0.94|0.11
70915172|NCT02263508|141321133|OTHER||Odds Ratio (OR)|1.44||||0.02|TWO_SIDED|95.0|1.06|1.96|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||1.96|1.06|0.020
70915173|NCT02263508|141321135|OTHER||Odds Ratio (OR)|1.59||||0.004|TWO_SIDED|95.0|1.16|2.17|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||2.17|1.16|0.004
70915174|NCT02263508|141321137|OTHER||Odds Ratio (OR)|1.35||||0.058|TWO_SIDED|95.0|0.99|1.85|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||1.85|0.99|0.058
70970723|NCT00609791|141447164|SUPERIORITY||Mean Difference (Final Values)|5.81||||0.15|TWO_SIDED|95.0|-2.3|13.9|||t-test, 2 sided|||Difference in age based on whether there was need for a dose omission.||13.9|-2.3|0.15
70915175|NCT02263508|141321138|OTHER||Difference|0.19|STANDARD_ERROR_OF_MEAN|0.95||0.84|TWO_SIDED|95.0|-1.67|2.05|||Mixed Model for Repeated Measures|||Mixed Model for Repeated Measures include the fixed and categorical effects of treatment, visit and treatment-by-visit interaction, the fixed and continuous covariates of baseline HRQL score, randomization stratification factors (stage of disease and prior BRAF inhibitor therapy per IVRS) and baseline PD-L1 status (positive and not positive). Random subject effect was modeled using within subject-error correlation structure.||2.05|-1.67|0.84
70915176|NCT00531518|141321140|SUPERIORITY_OR_OTHER|||||||0.0034|TWO_SIDED|||||The final analysis included adjstment for site and baseline sum psychotic symptom score.|Mixed Models Analysis|||The analysis used regression discontinuity methods, in which the baseline sum scores were adjusted and centered to an equalize control and experimental conditions.||||.0034
70915177|NCT03265210|141321141|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.39|TWO_SIDED|95.0|-4.95|1.95|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Baseline||1.95|-4.95|0.39
70915178|NCT03265210|141321141|SUPERIORITY||Mean Difference (Final Values)|-3.79||||0.03|TWO_SIDED|95.0|-7.19|-0.39|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|6 weeks||-0.39|-7.19|0.03
70915179|NCT03265210|141321141|SUPERIORITY||Mean Difference (Final Values)|-1.56||||0.42|TWO_SIDED|95.0|-5.38|2.26|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|9 weeks||2.26|-5.38|0.42
70915180|NCT03265210|141321141|SUPERIORITY||Mean Difference (Final Values)|-3.37||||0.07|TWO_SIDED|95.0|-7.02|0.28|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|12 weeks||0.28|-7.02|0.07
70915181|NCT03265210|141321142|SUPERIORITY||Mean Difference (Final Values)|-0.74||||0.17|TWO_SIDED|95.0|-1.81|0.33|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 1, Baseline||0.33|-1.81|0.17
70915182|NCT03265210|141321142|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.25|TWO_SIDED|95.0|-1.68|0.44|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 1, 6 weeks||0.44|-1.68|0.25
70915183|NCT03265210|141321142|SUPERIORITY||Mean Difference (Final Values)|-1.06||||0.09|TWO_SIDED|95.0|-2.29|0.17|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 1, 9 weeks||0.17|-2.29|0.09
70915184|NCT03265210|141321142|SUPERIORITY||Mean Difference (Final Values)|-1.09||||0.05|TWO_SIDED|95.0|-2.19|0.01|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 1, 12 weeks||0.01|-2.19|0.05
70970724|NCT00609791|141447164|SUPERIORITY||Mean Difference (Final Values)|-0.079||||0.61|TWO_SIDED|95.0|-0.39|0.23|||t-test, 2 sided|||Difference in AUC24 based on whether there was need for a dose omission.||0.23|-0.39|0.61
70915185|NCT03265210|141321142|SUPERIORITY||Mean Difference (Final Values)|-3.19||||0.02|TWO_SIDED|95.0|-5.9|-0.48|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 2, Baseline||-0.48|-5.90|0.02
70915186|NCT03265210|141321142|SUPERIORITY||Mean Difference (Final Values)|-4.3||||0.003|TWO_SIDED|95.0|-7.06|-1.54|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 2, 6 weeks||-1.54|-7.06|0.003
70915187|NCT03265210|141321142|SUPERIORITY||Mean Difference (Final Values)|-5.95||||0.0001|TWO_SIDED|95.0|-8.85|-3.05|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 2, 9 weeks||-3.05|-8.85|0.0001
70915188|NCT03265210|141321142|SUPERIORITY||Mean Difference (Final Values)|-4.35||||0.007|TWO_SIDED|95.0|-7.46|-1.24|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 2, 12 weeks||-1.24|-7.46|0.007
70915189|NCT03265210|141321143|SUPERIORITY||Mean Difference (Final Values)|1.11||||0.0003|TWO_SIDED|95.0|0.53|1.69|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 1||1.69|0.53|0.0003
70915190|NCT03265210|141321143|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.001|TWO_SIDED|95.0|0.21|0.83|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 2||0.83|0.21|0.001
70915191|NCT03265210|141321143|SUPERIORITY||Mean Difference (Final Values)|0.96||||0.002|TWO_SIDED|95.0|0.36|1.56|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 3||1.56|0.36|0.002
70915192|NCT03546907|141321155|SUPERIORITY||Risk Ratio (RR)|0.808||||0.1296|TWO_SIDED|95.0|0.613|1.065|||Negative binomial regression model|||Analysis was performed using negative binomial regression model with total number of events occurring during observation duration as response variable, treatment, baseline eosinophil strata, region, number of severe COPD exacerbations experienced in previous year(0 vs. 1+) at baseline, smoking history(current vs. former smoker), post-BD FEV1 percent(%) predicted (less than\[\<\] 50% vs greater than equal\[\>=\]50%) at baseline as covariates, and log-transformed observation duration as offset variable.||1.065|0.613|0.1296
70915193|NCT03110458|141321188|SUPERIORITY|||||||0.8466|||||||ANCOVA|||||||0.8466
70915194|NCT03110458|141321189|SUPERIORITY|||||||0.9538|||||||ANCOVA|||||||0.9538
70915195|NCT03110458|141321190|SUPERIORITY|||||||0.3166|||||||ANCOVA|||||||0.3166
70915196|NCT03110458|141321191|SUPERIORITY|||||||0.393|||||||ANCOVA|||||||0.393
70915197|NCT03110458|141321194|SUPERIORITY|||||||0.5324|||||||ANCOVA|||||||0.5324
70915198|NCT00286741|141321205|SUPERIORITY_OR_OTHER|||||||0.15|||||||Mixed Models Analysis|||||||0.15
70915199|NCT00286741|141321206|SUPERIORITY_OR_OTHER|||||||0.03|||||||Mixed Models Analysis|||||||0.03
70915200|NCT02633358|141321208|SUPERIORITY|Therapeutic hypothermia need to have superiority in the survival rate after 90 days|Risk Ratio (RR)|0.58|||<|0.001|TWO_SIDED|95.0|0.41|0.82||P-value less than 0.05 means significant data|Chi-squared|Test method for proportional data||Therapeutic hypothermia group compare with control group||0.82|0.41|<0.001
70915201|NCT02633358|141321209|SUPERIORITY|Therapeutic hypothermia nee to have superiority in neurological outcome in the 90 days after enrollment.|Risk Ratio (RR)|0.8||||0.04|TWO_SIDED|95.0|0.66|0.98||P value less than 0.05 means significant date|Chi-squared|Test method for proportional data||Therapeutic hypothermia group compare with control group||0.98|0.66|0.04
70915202|NCT02633358|141321210|SUPERIORITY||||||<|0.05||||||P-value less than 0.05 is statistical significance.|t-test, 2 sided|||||||<0.05
70915203|NCT02633358|141321211|SUPERIORITY||||||<|0.05||||||P-value less than 0.05 is statistical significance.|t-test, 2 sided|||||||<0.05
70915204|NCT02633358|141321212|SUPERIORITY||||||<|0.05||||||P-value less then 0.05 is statistical significance.|t-test, 2 sided|||||||<0.05
70970725|NCT00609791|141447164|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.51|TWO_SIDED|95.0|-0.22|0.42|||t-test, 2 sided|||Difference in clearance based on whether there was a need for a dose omission.||0.42|-0.22|0.51
70915205|NCT00957658|141321213|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 6%|||||<|0.0001|||||||Asymptotic WALD test|||Literature control = 96% with no aseptic loosening, intraop femoral fracture or thigh pain at 2 years||||<.0001
70915206|NCT00957658|141321216|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Improvement from preop to 2 year and preop to 5 year||||<.0001
70915207|NCT00957658|141321217|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Compare Pre-op SF-12 Physical Score preop to 2 year and preop to 5 year||||<.0001
70915208|NCT00957658|141321217|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in SF-12 Mental Score preop to 2 years||||<.0001
70915209|NCT00957658|141321217|SUPERIORITY_OR_OTHER|||||||0.0004|||||||t-test, 2 sided|||Compare SF-12 Mental Score preop to 5 years||||.0004
70915210|NCT00957658|141321218|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Compare LEAS score preop to 2 years and preop to 5 years||||<.0001
70915211|NCT00957658|141321221|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Compare to historical control (n=94 hips): mean wear 5 years = 0.134 (0.078)||||<.0001
70915212|NCT00957658|141321222|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Sign test|||Compare Wrist DXA T-score preop to 5 years||||.0002
70915213|NCT01193153|141321228|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.49|||<|0.001|TWO_SIDED|95.0|1.55|3.99|||Log Rank|||All participants: p-value was calculated using log-rank test.||3.99|1.55|<0.001
70915214|NCT01193153|141321228|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.38||||0.002|TWO_SIDED|95.0|1.57|7.28|||Regression, Cox|||Monotherapy subset: Hazard ratio and corresponding p-value, and 95% Confidence Interval (CI) were calculated from Cox proportional hazard regression model.||7.28|1.57|0.002
70915215|NCT01193153|141321228|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.03||||0.021|TWO_SIDED|95.0|1.11|3.68|||Regression, Cox|||Adjunct therapy subset: Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.||3.68|1.11|0.021
70915216|NCT01193153|141321228|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.82|||<|0.001|TWO_SIDED|95.0|1.7|4.67|||Regression, Cox|||Psychotic Symptoms: Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.||4.67|1.70|<0.001
70915217|NCT01193153|141321228|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.93|||<|0.001|TWO_SIDED|95.0|1.7|5.04|||Regression, Cox|||Mood Symptoms (Any Mood Symptoms):Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.||5.04|1.70|<0.001
70915218|NCT01193153|141321228|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.62||||0.012|TWO_SIDED|95.0|1.32|9.89|||Regression, Cox|||Mood Symptoms (Manic): Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.||9.89|1.32|0.012
70915219|NCT01193153|141321228|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.12||||0.006|TWO_SIDED|95.0|1.39|6.98|||Regression, Cox|||Mood Symptoms (Depressive): Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.||6.98|1.39|0.006
70915220|NCT01193153|141321228|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.93||||0.238|TWO_SIDED|95.0|0.65|5.78|||Regression, Cox|||Mood Symptoms (Mixed): Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.||5.78|0.65|0.238
70915221|NCT01193153|141321229|SUPERIORITY_OR_OTHER||Least Square Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|1.33||0.014|TWO_SIDED|95.0|0.68|5.95||P-value based on change from DB baseline in PSP score and was analyzed using mixed-model repeated measures analysis of covariance based on observed data; within-participant repeated measures were modeled using an unstructured covariance matrix.|MMRM ANCOVA|||The null hypothesis is that there is no difference in the mean of the PSP total score between the two treatment groups.||5.95|0.68|0.014
70915222|NCT01193153|141321231|SUPERIORITY_OR_OTHER||Least Square Mean Difference|4.5|||<|0.001|TWO_SIDED|95.0|1.94|7.15||Change at Endpoint (Week 64/LOCF)|ANCOVA|||||7.15|1.94|<0.001
70915223|NCT03621761|141321245|SUPERIORITY||Slope|1.774||||0.3451|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of CBT monotherapy vs. combination therapy (reference) on total MFIS score, in linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline MFIS score. Output reflects models that were imputed for missing data.||||0.3451
70915224|NCT03621761|141321245|SUPERIORITY||Slope|1.3094||||0.4834|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of modafinil monotherapy vs. combination therapy (reference) on total MFIS score, in linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline MFIS score. Output reflects models that were imputed for missing data.||||0.4834
70915225|NCT03621761|141321246|SUPERIORITY||Slope|0.4077||||0.257|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of CBT monotherapy vs. combination therapy (reference) on change in EMA fatigue intensity NRS score, in complete case linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline EMA fatigue intensity score.||||0.2570
70915226|NCT03621761|141321246|SUPERIORITY||Slope|-0.2452||||0.5017|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of modafinil monotherapy vs. combination therapy (reference) on change in EMA fatigue intensity NRS score, in complete case linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline EMA fatigue intensity score.||||0.5017
70915227|NCT03621761|141321247|SUPERIORITY||Slope|0.095||||0.154|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of CBT monotherapy vs. combination therapy (reference) on change in EMA fatigue interference NRS score, in complete case linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline EMA fatigue interference score.||||0.154
70915228|NCT03621761|141321247|SUPERIORITY||Slope|0.034||||0.61|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of modafinil monotherapy vs. combination therapy (reference) on change in EMA fatigue interference NRS score, in complete case linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline EMA fatigue interference score.||||0.610
70915229|NCT03621761|141321248|SUPERIORITY||Slope|0.00427||||0.4955|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of CBT monotherapy vs. combination therapy (reference) on change in fatigability score, in complete case linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline fatigability score.||||0.4955
70915230|NCT03621761|141321248|SUPERIORITY||Slope|-0.00948||||0.1333|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of modafinil monotherapy vs. combination therapy (reference) on change in fatigability score, in complete case linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline fatigability score.||||0.1333
70915231|NCT05046132|141321249|OTHER||Mean of Placebo-corrected CHFB|3.7|STANDARD_ERROR_OF_MEAN|1.48|||TWO_SIDED|90.0|1.23|6.17||||||"The C-QTc analysis was performed with a non-linear model.~The mean of placebo-corrected CHFB in QTcF at maximum concentration (Cmax) geometric mean of therapeutic dose (3 mg QD) was estimated with bias-corrected 90% CI by nonparametric bootstrap methods."||6.17|1.23|
70915232|NCT05046132|141321250|OTHER||Mean of Placebo-corrected CHFB|4.67|||||TWO_SIDED|90.0|1.7|7.64||||||The C-QTc analysis was performed with a non-linear model. The mean of placebo-corrected CHFB in QTcF at Cmax geometric mean of therapeutic dose (7 mg QD) was estimated with bias-corrected 90% CI by nonparametric bootstrap methods.||7.64|1.70|
70915233|NCT05046132|141321251|OTHER||LS Mean|2.5|||||TWO_SIDED|90.0|-0.6|5.6||||||Pre-dose||5.6|-0.6|
70915234|NCT05046132|141321251|OTHER||LS Mean|0.1|||||TWO_SIDED|90.0|-3.0|3.1||||||0.5 hr Post dose||3.1|-3.0|
70915235|NCT05046132|141321251|OTHER||LS Mean|0.1|||||TWO_SIDED|90.0|-2.8|3.0||||||1 hr Post dose||3.0|-2.8|
70915236|NCT05046132|141321251|OTHER||LS Mean|1.6|||||TWO_SIDED|90.0|-1.8|5.1||||||1.5 hr Post dose||5.1|-1.8|
70915237|NCT05046132|141321251|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-2.8|4.1||||||2 hr Post dose||4.1|-2.8|
70915238|NCT05046132|141321251|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-2.9|3.4||||||2.5 hr Post dose||3.4|-2.9|
70915239|NCT05046132|141321251|OTHER||LS Mean|2.2|||||TWO_SIDED|90.0|-1.4|5.7||||||3 hr Post dose||5.7|-1.4|
70915240|NCT05046132|141321251|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-2.9|2.7||||||4 hr Post dose||2.7|-2.9|
70915241|NCT05046132|141321251|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-3.1|2.7||||||5 hr Post dose||2.7|-3.1|
70915242|NCT05046132|141321251|OTHER||LS Mean|-0.8|||||TWO_SIDED|90.0|-3.8|2.3||||||6 hr Post dose||2.3|-3.8|
70915243|NCT05046132|141321251|OTHER||LS Mean|-2.8|||||TWO_SIDED|90.0|-5.5|-0.1||||||7 hr Post dose||-0.1|-5.5|
70915244|NCT05046132|141321251|OTHER||LS Mean|-1.6|||||TWO_SIDED|90.0|-4.5|1.3||||||8 hr Post dose||1.3|-4.5|
70915245|NCT05046132|141321251|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-2.5|3.0||||||9 hr Post dose||3.0|-2.5|
70915246|NCT05046132|141321251|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-2.3|2.7||||||10 hr Post dose||2.7|-2.3|
70915247|NCT05046132|141321251|OTHER||LS Mean|-3.0|||||TWO_SIDED|90.0|-5.9|-0.1||||||12 hr Post dose||-0.1|-5.9|
70915248|NCT05046132|141321251|OTHER||LS Mean|-2.0|||||TWO_SIDED|90.0|-5.1|1.0||||||16 hr Post dose||1.0|-5.1|
70915249|NCT05046132|141321251|OTHER||LS Mean|1.1|||||TWO_SIDED|90.0|-1.6|3.8||||||24 hr Post dose||3.8|-1.6|
70915250|NCT05046132|141321251|OTHER||LS Mean|1.4|||||TWO_SIDED|90.0|-1.7|4.5||||||Pre-dose||4.5|-1.7|
70915251|NCT05046132|141321251|OTHER||LS Mean|1.7|||||TWO_SIDED|90.0|-1.4|4.7||||||0.5 hr Post dose||4.7|-1.4|
70915252|NCT05046132|141321251|OTHER||LS Mean|1.9|||||TWO_SIDED|90.0|-1.0|4.8||||||1 hr Post dose||4.8|-1.0|
70915253|NCT05046132|141321251|OTHER||LS Mean|2.6|||||TWO_SIDED|90.0|-0.9|6.0||||||1.5 hr Post dose||6.0|-0.9|
70915254|NCT05046132|141321251|OTHER||LS Mean|1.3|||||TWO_SIDED|90.0|-2.1|4.8||||||2 hr Post dose||4.8|-2.1|
70915255|NCT05046132|141321251|OTHER||LS Mean|1.7|||||TWO_SIDED|90.0|-1.4|4.9||||||2.5 hr Post dose||4.9|-1.4|
70915256|NCT05046132|141321251|OTHER||LS Mean|1.6|||||TWO_SIDED|90.0|-1.9|5.1||||||3 hr Post dose||5.1|-1.9|
70915257|NCT05046132|141321251|OTHER||LS Mean|1.4|||||TWO_SIDED|90.0|-1.4|4.2||||||4 hr Post dose||4.2|-1.4|
70915258|NCT05046132|141321251|OTHER||LS Mean|2.7|||||TWO_SIDED|90.0|-0.2|5.7||||||5 hr Post dose||5.7|-0.2|
70915259|NCT05046132|141321251|OTHER||LS Mean|4.4|||||TWO_SIDED|90.0|1.4|7.5||||||6 hr Post dose||7.5|1.4|
70915260|NCT05046132|141321251|OTHER||LS Mean|2.8|||||TWO_SIDED|90.0|0.1|5.5||||||7 hr Post dose||5.5|0.1|
70915261|NCT05046132|141321251|OTHER||LS Mean|4.1|||||TWO_SIDED|90.0|1.2|7.0||||||8 hr Post dose||7.0|1.2|
70915262|NCT05046132|141321251|OTHER||LS Mean|3.6|||||TWO_SIDED|90.0|0.8|6.3||||||9 hr Post dose||6.3|0.8|
70915263|NCT05046132|141321251|OTHER||LS Mean|3.3|||||TWO_SIDED|90.0|0.8|5.8||||||10 hr Post dose||5.8|0.8|
70915264|NCT05046132|141321251|OTHER||LS Mean|2.6|||||TWO_SIDED|90.0|-0.3|5.5||||||12 hr Post dose||5.5|-0.3|
70915265|NCT05046132|141321251|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-2.7|3.4||||||16 hr Post dose||3.4|-2.7|
70915266|NCT05046132|141321251|OTHER||LS Mean|1.7|||||TWO_SIDED|90.0|-1.0|4.4||||||24 hr Post dose||4.4|-1.0|
70915267|NCT05046132|141321252|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-2.8|3.4||||||Pre dose||3.4|-2.8|
70915268|NCT05046132|141321252|OTHER||LS Mean|-2.1|||||TWO_SIDED|90.0|-5.3|1.0||||||0.5 hr Post dose||1.0|-5.3|
70915269|NCT05046132|141321252|OTHER||LS Mean|-1.6|||||TWO_SIDED|90.0|-4.7|1.4||||||1 hr Post dose||1.4|-4.7|
70915270|NCT05046132|141321252|OTHER||LS Mean|-2.2|||||TWO_SIDED|90.0|-5.3|1.0||||||1.5 hr Post dose||1.0|-5.3|
70915271|NCT05046132|141321252|OTHER||LS Mean|-3.3|||||TWO_SIDED|90.0|-6.3|-0.3||||||2 hr Post dose||-0.3|-6.3|
70915272|NCT05046132|141321252|OTHER||LS Mean|-1.2|||||TWO_SIDED|90.0|-4.1|1.7||||||2.5 hr Post dose||1.7|-4.1|
70915273|NCT05046132|141321252|OTHER||LS Mean|-1.3|||||TWO_SIDED|90.0|-4.2|1.7||||||3 hr Post dose||1.7|-4.2|
70915274|NCT05046132|141321252|OTHER||LS Mean|-0.6|||||TWO_SIDED|90.0|-3.6|2.5||||||4 hr Post dose||2.5|-3.6|
70915275|NCT05046132|141321252|OTHER||LS Mean|-1.0|||||TWO_SIDED|95.0|-4.1|2.1||||||5 hr Post dose||2.1|-4.1|
70915276|NCT05046132|141321252|OTHER||LS Mean|0.4|||||TWO_SIDED|90.0|-2.7|3.5||||||6 hr Post dose||3.5|-2.7|
70915277|NCT05046132|141321252|OTHER||LS Mean|-2.5|||||TWO_SIDED|90.0|-5.5|0.5||||||7 hr Post dose||0.5|-5.5|
70915278|NCT05046132|141321252|OTHER||LS Mean|-2.2|||||TWO_SIDED|90.0|-5.2|0.8||||||8 hr Post dose||0.8|-5.2|
70915279|NCT05046132|141321252|OTHER||LS Mean|-0.9|||||TWO_SIDED|90.0|-4.3|2.6||||||9 hr Post dose||2.6|-4.3|
70915280|NCT05046132|141321252|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-3.6|3.2||||||10 hr Post dose||3.2|-3.6|
70915281|NCT05046132|141321252|OTHER||LS Mean|-2.2|||||TWO_SIDED|90.0|-5.5|1.0||||||12 hr Post dose||1.0|-5.5|
70915282|NCT05046132|141321252|OTHER||LS Mean|-1.9|||||TWO_SIDED|90.0|-5.4|1.7||||||16 hr Post dose||1.7|-5.4|
70915283|NCT05046132|141321252|OTHER||LS Mean|2.6|||||TWO_SIDED|90.0|-1.2|6.3||||||24 hr Post dose||6.3|-1.2|
70915284|NCT05046132|141321252|OTHER||LS Mean|-2.1|||||TWO_SIDED|90.0|-5.1|0.8||||||Pre-dose||0.8|-5.1|
70915285|NCT05046132|141321252|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-3.1|3.0||||||0.5 hr Post dose||3.0|-3.1|
70915286|NCT05046132|141321252|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-3.0|2.9||||||1 hr Post dose||2.9|-3.0|
70915287|NCT05046132|141321252|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-3.1|3.0||||||1.5 hr Post dose||3.0|-3.1|
70915288|NCT05046132|141321252|OTHER||LS Mean|-0.9|||||TWO_SIDED|90.0|-3.8|2.0||||||2 hr Post dose||2.0|-3.8|
70915289|NCT05046132|141321252|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-2.5|3.0||||||2.5 hr Post dose||3.0|-2.5|
70915290|NCT05046132|141321252|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-1.9|3.7||||||3 hr Post dose||3.7|-1.9|
70915291|NCT05046132|141321252|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-2.2|3.7||||||4 hr Post dose||3.7|-2.2|
70915292|NCT05046132|141321252|OTHER||LS Mean|0.1|||||TWO_SIDED|90.0|-2.8|3.1||||||5 hr Post dose||3.1|-2.8|
70915293|NCT05046132|141321252|OTHER||LS Mean|-0.9|||||TWO_SIDED|90.0|-3.9|2.0||||||6 hr Post dose||2.0|-3.9|
70915294|NCT05046132|141321252|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-3.1|2.7||||||7 hr Post dose||2.7|-3.1|
70915295|NCT05046132|141321252|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-2.7|3.1||||||8 hr Post dose||3.1|-2.7|
70915296|NCT05046132|141321252|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-2.7|4.0||||||9 hr Post dose||4.0|-2.7|
70915297|NCT05046132|141321252|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-2.3|4.1||||||10 hr Post dose||4.1|-2.3|
70915298|NCT05046132|141321252|OTHER||LS Mean|-0.4|||||TWO_SIDED|90.0|-3.5|2.8||||||12 hr Post dose||2.8|-3.5|
70915299|NCT05046132|141321252|OTHER||LS Mean|-0.4|||||TWO_SIDED|90.0|-3.8|3.0||||||16 hr Post dose||3.0|-3.8|
70915300|NCT05046132|141321252|OTHER||LS Mean|-1.6|||||TWO_SIDED|90.0|-5.1|2.0||||||24 hr Post dose||2.0|-5.1|
70915301|NCT05046132|141321253|OTHER||LS Mean|3.5|||||TWO_SIDED|90.0|0.1|6.8||||||Pre dose||6.8|0.1|
70915302|NCT05046132|141321253|OTHER||LS Mean|0.8|||||TWO_SIDED|90.0|-3.0|4.6||||||0.5 hr Post dose||4.6|-3.0|
70915303|NCT05046132|141321253|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-4.1|3.9||||||1 hr Post dose||3.9|-4.1|
70915304|NCT05046132|141321253|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-2.7|4.4||||||1.5 hr Post dose||4.4|-2.7|
70915305|NCT05046132|141321253|OTHER||LS Mean|3.0|||||TWO_SIDED|90.0|-0.6|6.6||||||2 hr Post dose||6.6|-0.6|
70915306|NCT05046132|141321253|OTHER||LS Mean|3.5|||||TWO_SIDED|90.0|-0.3|7.4||||||2.5 hr Post dose||7.4|-0.3|
70915307|NCT05046132|141321253|OTHER||LS Mean|4.6|||||TWO_SIDED|90.0|1.2|8.1||||||3 hr Post dose||8.1|1.2|
70915308|NCT05046132|141321253|OTHER||LS Mean|5.2|||||TWO_SIDED|90.0|1.5|8.9||||||4 hr Post dose||8.9|1.5|
70915309|NCT05046132|141321253|OTHER||LS Mean|2.0|||||TWO_SIDED|90.0|-1.7|5.8||||||5 hr Post dose||5.8|-1.7|
70915310|NCT05046132|141321253|OTHER||LS Mean|1.7|||||TWO_SIDED|90.0|-1.6|5.1||||||6 hr Post dose||5.1|-1.6|
70915311|NCT05046132|141321253|OTHER||LS Mean|2.3|||||TWO_SIDED|90.0|-1.1|5.7||||||7 hr Post dose||5.7|-1.1|
70915312|NCT05046132|141321253|OTHER||LS Mean|2.4|||||TWO_SIDED|90.0|-1.4|6.2||||||8 hr Post dose||6.2|-1.4|
70915313|NCT05046132|141321253|OTHER||LS Mean|4.4|||||TWO_SIDED|90.0|0.9|7.8||||||9 hr Post dose||7.8|0.9|
70915314|NCT05046132|141321253|OTHER||LS Mean|3.8|||||TWO_SIDED|90.0|0.3|7.4||||||10 hr Post dose||7.4|0.3|
70915315|NCT05046132|141321253|OTHER||LS Mean|-0.8|||||TWO_SIDED|90.0|-4.2|2.7||||||12 hr Post dose||2.7|-4.2|
70915316|NCT05046132|141321253|OTHER||LS Mean|3.6|||||TWO_SIDED|90.0|0.1|7.0||||||16 hr Post dose||7.0|0.1|
70915317|NCT05046132|141321253|OTHER||LS Mean|-1.5|||||TWO_SIDED|90.0|-5.7|2.8||||||24 hr Post dose||2.8|-5.7|
70915318|NCT05046132|141321253|OTHER||LS Mean|2.3|||||TWO_SIDED|90.0|-1.0|5.6||||||Pre dose||5.6|-1.0|
70915319|NCT05046132|141321253|OTHER||LS Mean|-1.6|||||TWO_SIDED|90.0|-5.4|2.2||||||0.5 hr Post dose||2.2|-5.4|
70915320|NCT05046132|141321253|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-3.8|4.3||||||1 hr Post dose||4.3|-3.8|
70915321|NCT05046132|141321253|OTHER||LS Mean|4.0|||||TWO_SIDED|90.0|0.4|7.6||||||1.5 hr Post dose||7.6|0.4|
70915322|NCT05046132|141321253|OTHER||LS Mean|6.3|||||TWO_SIDED|90.0|2.7|10.0||||||2 hr Post dose||10.0|2.7|
70915323|NCT05046132|141321253|OTHER||LS Mean|6.4|||||TWO_SIDED|90.0|2.6|10.2||||||2.5 hr Post dose||10.2|2.6|
70915324|NCT05046132|141321253|OTHER||LS Mean|8.5|||||TWO_SIDED|90.0|5.0|12.0||||||3 hr Post dose||12.0|5.0|
70915325|NCT05046132|141321253|OTHER||LS Mean|10.1|||||TWO_SIDED|90.0|6.4|13.8||||||4 hr Post dose||13.8|6.4|
70915326|NCT05046132|141321253|OTHER||LS Mean|7.8|||||TWO_SIDED|90.0|4.1|11.6||||||5 hr Post dose||11.6|4.1|
70915327|NCT05046132|141321253|OTHER||LS Mean|7.8|||||TWO_SIDED|90.0|4.4|11.2||||||6 hr Post dose||11.2|4.4|
70915328|NCT05046132|141321253|OTHER||LS Mean|6.8|||||TWO_SIDED|90.0|3.4|10.2||||||7 hr Post dose||10.2|3.4|
70915329|NCT05046132|141321253|OTHER||LS Mean|4.5|||||TWO_SIDED|90.0|0.6|8.3||||||8 hr Post dose||8.3|0.6|
70915330|NCT05046132|141321253|OTHER||LS Mean|6.5|||||TWO_SIDED|90.0|3.1|10.0||||||9 hr Post dose||10.0|3.1|
70915331|NCT05046132|141321253|OTHER||LS Mean|6.6|||||TWO_SIDED|90.0|3.0|10.1||||||10 hr Post dose||10.1|3.0|
70915332|NCT05046132|141321253|OTHER||LS Mean|5.3|||||TWO_SIDED|90.0|1.8|8.8||||||12 hr Post dose||8.8|1.8|
70915333|NCT05046132|141321253|OTHER||LS Mean|7.2|||||TWO_SIDED|90.0|3.7|10.6||||||16 hr Post dose||10.6|3.7|
70915334|NCT05046132|141321253|OTHER||LS Mean|3.3|||||TWO_SIDED|90.0|-1.0|7.5||||||24 hr Post dose||7.5|-1.0|
70915335|NCT05046132|141321254|OTHER||LS Mean|7.8|||||TWO_SIDED|90.0|3.7|11.8||||||Pre dose||11.8|3.7|
70915336|NCT05046132|141321254|OTHER||LS Mean|6.5|||||TWO_SIDED|90.0|3.3|9.8||||||0.5 hr Post dose||9.8|3.3|
70915337|NCT05046132|141321254|OTHER||LS Mean|4.6|||||TWO_SIDED|90.0|0.6|8.6||||||1 hr Post dose||8.6|0.6|
70915338|NCT05046132|141321254|OTHER||LS Mean|4.6|||||TWO_SIDED|90.0|0.6|8.6||||||1.5 hr Post dose||8.6|0.6|
70915339|NCT05046132|141321254|OTHER||LS Mean|3.8|||||TWO_SIDED|90.0|-0.4|8.0||||||2 hr Post dose||8.0|-0.4|
70915340|NCT05046132|141321254|OTHER||LS Mean|6.1|||||TWO_SIDED|90.0|1.8|10.4||||||2.5 hr Post dose||10.4|1.8|
70915341|NCT05046132|141321254|OTHER||LS Mean|5.7|||||TWO_SIDED|90.0|1.7|9.8||||||3 hr Post dose||9.8|1.7|
70915342|NCT05046132|141321254|OTHER||LS Mean|6.2|||||TWO_SIDED|90.0|2.5|9.8||||||4 hr Post dose||9.8|2.5|
70915343|NCT05046132|141321254|OTHER||LS Mean|5.7|||||TWO_SIDED|90.0|1.6|9.8||||||5 hr Post dose||9.8|1.6|
70915344|NCT05046132|141321254|OTHER||LS Mean|4.8|||||TWO_SIDED|90.0|1.1|8.4||||||6 hr Post dose||8.4|1.1|
70915345|NCT05046132|141321254|OTHER||LS Mean|3.0|||||TWO_SIDED|90.0|-0.9|7.0||||||7 hr Post dose||7.0|-0.9|
70915346|NCT05046132|141321254|OTHER||LS Mean|5.0|||||TWO_SIDED|90.0|1.3|8.8||||||8 hr Post dose||8.8|1.3|
70915347|NCT05046132|141321254|OTHER||LS Mean|6.5|||||TWO_SIDED|90.0|2.5|10.6||||||9 hr Post dose||10.6|2.5|
70915348|NCT05046132|141321254|OTHER||LS Mean|8.6|||||TWO_SIDED|90.0|4.8|12.3||||||10 hr Post dose||12.3|4.8|
70915349|NCT05046132|141321254|OTHER||LS Mean|7.9|||||TWO_SIDED|90.0|4.4|11.4||||||12 hr Post dose||11.4|4.4|
70915350|NCT05046132|141321254|OTHER||LS Mean|4.9|||||TWO_SIDED|90.0|0.9|8.9||||||16 hr Post dose||8.9|0.9|
70915351|NCT05046132|141321254|OTHER||LS Mean|7.8|||||TWO_SIDED|90.0|3.6|12.0||||||24 hr Post dose||12.0|3.6|
70915352|NCT05046132|141321254|OTHER||LS Mean|2.1|||||TWO_SIDED|90.0|-1.8|6.0||||||Pre dose||6.0|-1.8|
70915353|NCT05046132|141321254|OTHER||LS Mean|3.1|||||TWO_SIDED|90.0|0.0|6.2||||||0.5 hr Post dose||6.2|-0.0|
70915354|NCT05046132|141321254|OTHER||LS Mean|1.9|||||TWO_SIDED|90.0|-1.9|5.7||||||1 hr Post dose||5.7|-1.9|
70915355|NCT05046132|141321254|OTHER||LS Mean|6.5|||||TWO_SIDED|90.0|2.6|10.4||||||1.5 hr Post dose||10.4|2.6|
70915356|NCT05046132|141321254|OTHER||LS Mean|5.3|||||TWO_SIDED|90.0|1.3|9.3||||||2 hr Post dose||9.3|1.3|
70915357|NCT05046132|141321254|OTHER||LS Mean|11.1|||||TWO_SIDED|90.0|7.0|15.1||||||2.5 hr Post dose||15.1|7.0|
70915358|NCT05046132|141321254|OTHER||LS Mean|9.8|||||TWO_SIDED|90.0|5.9|13.6||||||3 hr Post dose||13.6|5.9|
71153909|NCT00488683|141800059|SUPERIORITY_OR_OTHER||R-square|0.25||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination||||
70915359|NCT05046132|141321254|OTHER||LS Mean|10.7|||||TWO_SIDED|90.0|7.2|14.2||||||4 hr Post dose||14.2|7.2|
70915360|NCT05046132|141321254|OTHER||LS Mean|8.8|||||TWO_SIDED|90.0|4.9|12.7||||||5 hr Post dose||12.7|4.9|
70915361|NCT05046132|141321254|OTHER||LS Mean|11.0|||||TWO_SIDED|90.0|7.5|14.5||||||6 hr Post dose||14.5|7.5|
70915362|NCT05046132|141321254|OTHER||LS Mean|10.8|||||TWO_SIDED|90.0|7.1|14.6||||||7 hr Post dose||14.6|7.1|
70915363|NCT05046132|141321254|OTHER||LS Mean|11.3|||||TWO_SIDED|90.0|7.6|14.9||||||8 hr Post dose||14.9|7.6|
70915364|NCT05046132|141321254|OTHER||LS Mean|9.8|||||TWO_SIDED|90.0|5.9|13.7||||||9 hr Post dose||13.7|5.9|
70915365|NCT05046132|141321254|OTHER||LS Mean|10.5|||||TWO_SIDED|90.0|6.9|14.1||||||10 hr Post dose||14.1|6.9|
70915366|NCT05046132|141321254|OTHER||LS Mean|11.8|||||TWO_SIDED|90.0|8.4|15.2||||||12 hr Post dose||15.2|8.4|
70915367|NCT05046132|141321254|OTHER||LS Mean|9.4|||||TWO_SIDED|90.0|5.6|13.3||||||16 hr Post dose||13.3|5.6|
70915368|NCT05046132|141321254|OTHER||LS Mean|10.8|||||TWO_SIDED|90.0|6.8|14.9||||||24 hr Post dose||14.9|6.8|
70915369|NCT05046132|141321255|OTHER||LS Mean|-5.3|||||TWO_SIDED|90.0|-8.4|-2.2||||||Pre dose||-2.2|-8.4|
70915370|NCT05046132|141321255|OTHER||LS Mean|-2.7|||||TWO_SIDED|90.0|-5.9|0.5||||||0.5 hr Post dose||0.5|-5.9|
70915371|NCT05046132|141321255|OTHER||LS Mean|-3.2|||||TWO_SIDED|90.0|-5.7|-0.7||||||1 hr Post dose||-0.7|-5.7|
70915372|NCT05046132|141321255|OTHER||LS Mean|-0.9|||||TWO_SIDED|90.0|-3.7|1.9||||||1.5 hr Post dose||1.9|-3.7|
70915373|NCT05046132|141321255|OTHER||LS Mean|-2.9|||||TWO_SIDED|90.0|-5.7|-0.2||||||2 hr Post dose||-0.2|-5.7|
70915374|NCT05046132|141321255|OTHER||LS Mean|-4.0|||||TWO_SIDED|90.0|-6.5|-1.5||||||2.5 hr Post dose||-1.5|-6.5|
70915375|NCT05046132|141321255|OTHER||LS Mean|-4.2|||||TWO_SIDED|90.0|-7.1|-1.3||||||3 hr Post dose||-1.3|-7.1|
70915376|NCT05046132|141321255|OTHER||LS Mean|-4.1|||||TWO_SIDED|90.0|-7.4|-0.8||||||4 hr Post dose||-0.8|-7.4|
70915377|NCT05046132|141321255|OTHER||LS Mean|-0.8|||||TWO_SIDED|90.0|-3.7|2.1||||||5 hr Post dose||2.1|-3.7|
70915378|NCT05046132|141321255|OTHER||LS Mean|-3.3|||||TWO_SIDED|90.0|-6.3|-0.4||||||6 hr Post dose||-0.4|-6.3|
70915379|NCT05046132|141321255|OTHER||LS Mean|-3.3|||||TWO_SIDED|90.0|-6.0|-0.5||||||7 hr Post dose||-0.5|-6.0|
70915380|NCT05046132|141321255|OTHER||LS Mean|-1.6|||||TWO_SIDED|90.0|-4.7|1.5||||||8 hr Post dose||1.5|-4.7|
70915381|NCT05046132|141321255|OTHER||LS Mean|-4.0|||||TWO_SIDED|90.0|-6.9|-1.2||||||9 hr Post dose||-1.2|-6.9|
70915382|NCT05046132|141321255|OTHER||LS Mean|-4.3|||||TWO_SIDED|90.0|-7.6|-1.0||||||10 hr Post dose||-1.0|-7.6|
70915383|NCT05046132|141321255|OTHER||LS Mean|-5.4|||||TWO_SIDED|90.0|-8.7|-2.1||||||12 hr Post dose||-2.1|-8.7|
70915384|NCT05046132|141321255|OTHER||LS Mean|-4.1|||||TWO_SIDED|90.0|-7.4|-0.8||||||16 hr Post dose||-0.8|-7.4|
70915385|NCT05046132|141321255|OTHER||LS Mean|-7.1|||||TWO_SIDED|90.0|-10.1|-4.2||||||24 hr Post dose||-4.2|-10.1|
70915386|NCT05046132|141321255|OTHER||LS Mean|1.1|||||TWO_SIDED|90.0|-2.0|4.2||||||Pre dose||4.2|-2.0|
70915387|NCT05046132|141321255|OTHER||LS Mean|3.1|||||TWO_SIDED|90.0|-0.1|6.3||||||0.5 hr Post dose||6.3|-0.1|
70915388|NCT05046132|141321255|OTHER||LS Mean|2.4|||||TWO_SIDED|90.0|-0.1|4.9||||||1 hr Post dose||4.9|-0.1|
70915389|NCT05046132|141321255|OTHER||LS Mean|3.0|||||TWO_SIDED|90.0|0.2|5.8||||||1.5 hr Post dose||5.8|0.2|
70915390|NCT05046132|141321255|OTHER||LS Mean|1.8|||||TWO_SIDED|90.0|-1.0|4.6||||||2 hr Post dose||4.6|-1.0|
70915391|NCT05046132|141321255|OTHER||LS Mean|0.6|||||TWO_SIDED|90.0|-1.9|3.1||||||2.5 hr Post dose||3.1|-1.9|
70915392|NCT05046132|141321255|OTHER||LS Mean|1.9|||||TWO_SIDED|90.0|-1.0|4.8||||||3 hr Post dose||4.8|-1.0|
70915393|NCT05046132|141321255|OTHER||LS Mean|-0.3|||||TWO_SIDED|90.0|-3.5|3.0||||||4 hr Post dose||3.0|-3.5|
70915394|NCT05046132|141321255|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-2.6|3.2||||||5 hr Post dose||3.2|-2.6|
70915395|NCT05046132|141321255|OTHER||LS Mean|-1.9|||||TWO_SIDED|90.0|-4.8|1.1||||||6 hr Post dose||1.1|-4.8|
70915396|NCT05046132|141321255|OTHER||LS Mean|-1.1|||||TWO_SIDED|90.0|-3.8|1.7||||||7 hr Post dose||1.7|-3.8|
70915397|NCT05046132|141321255|OTHER||LS Mean|-0.5|||||TWO_SIDED|90.0|-3.6|2.6||||||8 hr Post dose||2.6|-3.6|
70915398|NCT05046132|141321255|OTHER||LS Mean|-2.7|||||TWO_SIDED|90.0|-5.6|0.2||||||9 hr Post dose||0.2|-5.6|
70915399|NCT05046132|141321255|OTHER||LS Mean|-3.5|||||TWO_SIDED|90.0|-6.8|-0.2||||||10 hr Post dose||-0.2|-6.8|
70915400|NCT05046132|141321255|OTHER||LS Mean|-3.3|||||TWO_SIDED|90.0|-6.6|0.1||||||12 hr Post dose||0.1|-6.6|
70915401|NCT05046132|141321255|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-3.0|3.6||||||16 hr Post dose||3.6|-3.0|
70915402|NCT05046132|141321255|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-3.0|2.9||||||24 hr Post dose||2.9|-3.0|
70915403|NCT05046132|141321256|OTHER||LS Mean|-6.6|||||TWO_SIDED|90.0|-10.3|-3.0||||||Pre dose||-3.0|-10.3|
70915404|NCT05046132|141321256|OTHER||LS Mean|-7.3|||||TWO_SIDED|90.0|-10.5|-4.0||||||0.5 hr Post dose||-4.0|-10.5|
70915405|NCT05046132|141321256|OTHER||LS Mean|-5.0|||||TWO_SIDED|90.0|-8.8|-1.2||||||1 hr Post dose||-1.2|-8.8|
70915406|NCT05046132|141321256|OTHER||LS Mean|-5.0|||||TWO_SIDED|90.0|-8.4|-1.6||||||1.5 hr Post dose||-1.6|-8.4|
70915407|NCT05046132|141321256|OTHER||LS Mean|-3.5|||||TWO_SIDED|90.0|-6.6|-0.3||||||2 hr Post dose||-0.3|-6.6|
70915408|NCT05046132|141321256|OTHER||LS Mean|-2.9|||||TWO_SIDED|90.0|-6.1|0.3||||||2.5 hr Post dose||0.3|-6.1|
70915409|NCT05046132|141321256|OTHER||LS Mean|-4.6|||||TWO_SIDED|90.0|-7.7|-1.5||||||3 hr Post dose||-1.5|-7.7|
70915410|NCT05046132|141321256|OTHER||LS Mean|-7.1|||||TWO_SIDED|90.0|-10.3|-3.8||||||4 hr Post dose||-3.8|-10.3|
70915411|NCT05046132|141321256|OTHER||LS Mean|-3.2|||||TWO_SIDED|90.0|-6.9|0.6||||||5 hr Post dose||0.6|-6.9|
70915412|NCT05046132|141321256|OTHER||LS Mean|-4.2|||||TWO_SIDED|90.0|-7.8|-0.6||||||6 hr Post dose||-0.6|-7.8|
70915413|NCT05046132|141321256|OTHER||LS Mean|-4.8|||||TWO_SIDED|90.0|-8.1|-1.6||||||7 hr Post dose||-1.6|-8.1|
70915414|NCT05046132|141321256|OTHER||LS Mean|-4.4|||||TWO_SIDED|90.0|-7.8|-1.1||||||8 hr Post dose||-1.1|-7.8|
70915415|NCT05046132|141321256|OTHER||LS Mean|-5.9|||||TWO_SIDED|90.0|-9.3|-2.6||||||9 hr Post dose||-2.6|-9.3|
70915416|NCT05046132|141321256|OTHER||LS Mean|-4.4|||||TWO_SIDED|90.0|-7.8|-1.1||||||10 hr Post dose||-1.1|-7.8|
70915417|NCT05046132|141321256|OTHER||LS Mean|-4.2|||||TWO_SIDED|90.0|-7.3|-1.1||||||12 hr Post dose||-1.1|-7.3|
70915418|NCT05046132|141321256|OTHER||LS Mean|-5.8|||||TWO_SIDED|90.0|-9.7|-2.0||||||16 hr Post dose||-2.0|-9.7|
70915419|NCT05046132|141321256|OTHER||LS Mean|-8.2|||||TWO_SIDED|90.0|-12.5|-3.8||||||24 hr Post dose||-3.8|-12.5|
70915420|NCT05046132|141321256|OTHER||LS Mean|2.4|||||TWO_SIDED|90.0|-1.2|5.9||||||Pre dose||5.9|-1.2|
70915421|NCT05046132|141321256|OTHER||LS Mean|-1.4|||||TWO_SIDED|90.0|-4.5|1.8||||||0.5 hr Post dose||1.8|-4.5|
70915422|NCT05046132|141321256|OTHER||LS Mean|-0.4|||||TWO_SIDED|90.0|-4.0|3.3||||||1 hr Post dose||3.3|-4.0|
70915423|NCT05046132|141321256|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-3.0|3.6||||||1.5 hr Post dose||3.6|-3.0|
70915424|NCT05046132|141321256|OTHER||LS Mean|-1.0|||||TWO_SIDED|90.0|-4.0|2.0||||||2 hr Post dose||2.0|-4.0|
70915425|NCT05046132|141321256|OTHER||LS Mean|0.5|||||TWO_SIDED|90.0|-2.6|3.6||||||2.5 hr Post dose||3.6|-2.6|
70915426|NCT05046132|141321256|OTHER||LS Mean|-0.7|||||TWO_SIDED|90.0|-3.7|2.3||||||3 hr Post dose||2.3|-3.7|
70915427|NCT05046132|141321256|OTHER||LS Mean|-2.3|||||TWO_SIDED|90.0|-5.4|0.9||||||4 hr Post dose||0.9|-5.4|
70915428|NCT05046132|141321256|OTHER||LS Mean|1.1|||||TWO_SIDED|90.0|-2.5|4.6||||||5 hr Post dose||4.6|-2.5|
70915429|NCT05046132|141321256|OTHER||LS Mean|-0.7|||||TWO_SIDED|90.0|-4.1|2.8||||||6 hr Post dose||2.8|-4.1|
70915430|NCT05046132|141321256|OTHER||LS Mean|-1.9|||||TWO_SIDED|90.0|-5.0|1.3||||||7 hr Post dose||1.3|-5.0|
70915431|NCT05046132|141321256|OTHER||LS Mean|-0.5|||||TWO_SIDED|90.0|-3.7|2.8||||||8 hr Post dose||2.8|-3.7|
70915432|NCT05046132|141321256|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-3.4|3.1||||||9 hr Post dose||3.1|-3.4|
70915433|NCT05046132|141321256|OTHER||LS Mean|0.4|||||TWO_SIDED|90.0|-2.8|3.7||||||10 hr Post dose||3.7|-2.8|
70915434|NCT05046132|141321256|OTHER||LS Mean|0.1|||||TWO_SIDED|90.0|-2.9|3.1||||||12 hr Post dose||3.1|-2.9|
70915435|NCT05046132|141321256|OTHER||LS Mean|0.6|||||TWO_SIDED|90.0|-3.1|4.3||||||16 hr Post dose||4.3|-3.1|
70915436|NCT05046132|141321256|OTHER||LS Mean|1.7|||||TWO_SIDED|90.0|-2.5|5.9||||||24 hr Post dose||5.9|-2.5|
70915437|NCT05046132|141321257|OTHER||LS Mean|-0.7|||||TWO_SIDED|90.0|-2.6|1.2||||||Pre dose||1.2|-2.6|
70915438|NCT05046132|141321257|OTHER||LS Mean|-0.9|||||TWO_SIDED|90.0|-2.6|0.7||||||0.5 hr post dose||0.7|-2.6|
70915439|NCT05046132|141321257|OTHER||LS Mean|0.6|||||TWO_SIDED|90.0|-1.1|2.3||||||1 hr post dose||2.3|-1.1|
70915440|NCT05046132|141321257|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-1.5|1.3||||||1.5 hr post dose||1.3|-1.5|
70915441|NCT05046132|141321257|OTHER||LS Mean|0.8|||||TWO_SIDED|90.0|-0.8|2.4||||||2 hr post dose||2.4|-0.8|
70915442|NCT05046132|141321257|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-1.0|2.4||||||2.5 hr post dose||2.4|-1.0|
70915443|NCT05046132|141321257|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-1.6|2.0||||||3 hr post dose||2.0|-1.6|
70915444|NCT05046132|141321257|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-0.9|2.3||||||4 hr post dose||2.3|-0.9|
70915445|NCT05046132|141321257|OTHER||LS Mean|0.5|||||TWO_SIDED|90.0|-1.2|2.1||||||5 hr post dose||2.1|-1.2|
70915446|NCT05046132|141321257|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-0.7|2.4||||||6 hr post dose||2.4|-0.7|
70915447|NCT05046132|141321257|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-0.6|2.4||||||7 hr post dose||2.4|-0.6|
70915448|NCT05046132|141321257|OTHER||LS Mean|0.6|||||TWO_SIDED|90.0|-1.0|2.2||||||8 hr post dose||2.2|-1.0|
70915449|NCT05046132|141321257|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-1.6|1.3||||||9 hr post dose||1.3|-1.6|
70915450|NCT05046132|141321257|OTHER||LS Mean|0.0|||||TWO_SIDED|90.0|-1.5|1.6||||||10 hr post dose||1.6|-1.5|
70915451|NCT05046132|141321257|OTHER||LS Mean|1.4|||||TWO_SIDED|90.0|-0.2|3.0||||||12 hr post dose||3.0|-0.2|
70915452|NCT05046132|141321257|OTHER||LS Mean|1.5|||||TWO_SIDED|90.0|-0.3|3.4||||||16 hr post dose||3.4|-0.3|
70915453|NCT05046132|141321257|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-2.1|1.6||||||24 hr post dose||1.6|-2.1|
70915454|NCT05046132|141321257|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-1.2|2.6||||||Pre dose||2.6|-1.2|
70915455|NCT05046132|141321257|OTHER||LS Mean|-0.3|||||TWO_SIDED|90.0|-1.9|1.4||||||0.5 hr post dose||1.4|-1.9|
70915456|NCT05046132|141321257|OTHER||LS Mean|0.5|||||TWO_SIDED|90.0|-1.2|2.2||||||1 hr post dose||2.2|-1.2|
70915457|NCT05046132|141321257|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-0.7|2.1||||||1.5 hr post dose||2.1|-0.7|
70915458|NCT05046132|141321257|OTHER||LS Mean|0.6|||||TWO_SIDED|90.0|-1.1|2.2||||||2 hr post dose||2.2|-1.1|
70915459|NCT05046132|141321257|OTHER||LS Mean|0.8|||||TWO_SIDED|90.0|-0.9|2.5||||||2.5 hr post dose||2.5|-0.9|
70915460|NCT05046132|141321257|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-1.5|2.1||||||3 hr post dose||2.1|-1.5|
70915461|NCT05046132|141321257|OTHER||LS Mean|-0.5|||||TWO_SIDED|90.0|-2.1|1.1||||||4 hr post dose||1.1|-2.1|
70915462|NCT05046132|141321257|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-1.5|1.9||||||5 hr post dose||1.9|-1.5|
70915463|NCT05046132|141321257|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-1.7|1.4||||||6 hr post dose||1.4|-1.7|
70915464|NCT05046132|141321257|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-1.6|1.4||||||7 hr post dose||1.4|-1.6|
70915465|NCT05046132|141321257|OTHER||LS Mean|0.8|||||TWO_SIDED|90.0|-0.7|2.4||||||8 hr post dose||2.4|-0.7|
70915466|NCT05046132|141321257|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-1.6|1.3||||||9 hr post dose||1.3|-1.6|
70915467|NCT05046132|141321257|OTHER||LS Mean|0.1|||||TWO_SIDED|90.0|-1.4|1.6||||||10 hr post dose||1.6|-1.4|
70915468|NCT05046132|141321257|OTHER||LS Mean|1.5|||||TWO_SIDED|90.0|-0.1|3.1||||||12 hr post dose||3.1|-0.1|
70915469|NCT05046132|141321257|OTHER||LS Mean|1.2|||||TWO_SIDED|90.0|-0.7|3.0||||||16 hr post dose||3.0|-0.7|
70915470|NCT05046132|141321257|OTHER||LS Mean|1.5|||||TWO_SIDED|90.0|-0.3|3.4||||||24 hr post dose||3.4|-0.3|
70915471|NCT05046132|141321258|OTHER||LS Mean|0.8|||||TWO_SIDED|90.0|-1.3|2.9||||||Pre dose||2.9|-1.3|
70915472|NCT05046132|141321258|OTHER||LS Mean|-0.3|||||TWO_SIDED|90.0|-1.8|1.2||||||0.5 hr post dose||1.2|-1.8|
70915473|NCT05046132|141321258|OTHER||LS Mean|1.2|||||TWO_SIDED|90.0|-1.4|3.8||||||1 hr post dose||3.8|-1.4|
70915474|NCT05046132|141321258|OTHER||LS Mean|0.0|||||TWO_SIDED|90.0|-1.8|1.8||||||1.5 hr post dose||1.8|-1.8|
70915475|NCT05046132|141321258|OTHER||LS Mean|-1.4|||||TWO_SIDED|90.0|-3.0|0.3||||||2 hr post dose||0.3|-3.0|
70915476|NCT05046132|141321258|OTHER||LS Mean|1.6|||||TWO_SIDED|90.0|0.0|3.1||||||2.5 hr post dose||3.1|-0.0|
70915477|NCT05046132|141321258|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-1.7|1.5||||||3 hr post dose||1.5|-1.7|
70915478|NCT05046132|141321258|OTHER||LS Mean|1.3|||||TWO_SIDED|90.0|-0.3|2.9||||||4 hr post dose||2.9|-0.3|
70915479|NCT05046132|141321258|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-2.2|2.0||||||5 hr post dose||2.0|-2.2|
70915480|NCT05046132|141321258|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-0.8|2.3||||||6 hr post dose||2.3|-0.8|
70915481|NCT05046132|141321258|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-0.8|2.7||||||7 hr post dose||2.7|-0.8|
70915482|NCT05046132|141321258|OTHER||LS Mean|1.0|||||TWO_SIDED|90.0|-0.3|2.4||||||8 hr post dose||2.4|-0.3|
70915483|NCT05046132|141321258|OTHER||LS Mean|1.1|||||TWO_SIDED|90.0|-0.7|2.9||||||9 hr post dose||2.9|-0.7|
70915484|NCT05046132|141321258|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-1.4|1.9||||||10 hr post dose||1.9|-1.4|
70915485|NCT05046132|141321258|OTHER||LS Mean|1.3|||||TWO_SIDED|90.0|-0.6|3.2||||||12 hr post dose||3.2|-0.6|
70915486|NCT05046132|141321258|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-1.0|2.4||||||16 hr post dose||2.4|-1.0|
70915487|NCT05046132|141321258|OTHER||LS Mean|1.6|||||TWO_SIDED|90.0|-1.0|4.2||||||24 hr post dose||4.2|-1.0|
70915488|NCT05046132|141321258|OTHER||LS Mean|-0.3|||||TWO_SIDED|90.0|-2.3|1.7||||||Pre dose||1.7|-2.3|
70915489|NCT05046132|141321258|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-1.6|1.3||||||0.5 hr post dose||1.3|-1.6|
70915490|NCT05046132|141321258|OTHER||LS Mean|-1.3|||||TWO_SIDED|90.0|-3.8|1.2||||||1 hr post dose||1.2|-3.8|
70915491|NCT05046132|141321258|OTHER||LS Mean|0.1|||||TWO_SIDED|90.0|-1.7|1.8||||||1.5 hr post dose||1.8|-1.7|
70915492|NCT05046132|141321258|OTHER||LS Mean|-1.1|||||TWO_SIDED|90.0|-2.7|0.5||||||2 hr post dose||0.5|-2.7|
70915493|NCT05046132|141321258|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-0.8|2.3||||||2.5 hr post dose||2.3|-0.8|
70915494|NCT05046132|141321258|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-1.3|1.8||||||3 hr post dose||1.8|-1.3|
70915495|NCT05046132|141321258|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-1.2|1.9||||||4 hr post dose||1.9|-1.2|
70915496|NCT05046132|141321258|OTHER||LS Mean|-1.5|||||TWO_SIDED|90.0|-3.5|0.5||||||5 hr post dose||0.5|-3.5|
70915497|NCT05046132|141321258|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-0.6|2.3||||||6 hr post dose||2.3|-0.6|
70915498|NCT05046132|141321258|OTHER||LS Mean|0.4|||||TWO_SIDED|90.0|-1.3|2.1||||||7 hr post dose||2.1|-1.3|
70915499|NCT05046132|141321258|OTHER||LS Mean|1.3|||||TWO_SIDED|90.0|0.0|2.6||||||8 hr post dose||2.6|-0.0|
70915500|NCT05046132|141321258|OTHER||LS Mean|0.4|||||TWO_SIDED|90.0|-1.3|2.2||||||9 hr post dose||2.2|-1.3|
70915501|NCT05046132|141321258|OTHER||LS Mean|-1.1|||||TWO_SIDED|90.0|-2.7|0.5||||||10 hr post dose||0.5|-2.7|
70915502|NCT05046132|141321258|OTHER||LS Mean|-0.3|||||TWO_SIDED|90.0|-2.1|1.5||||||12 hr post dose||1.5|-2.1|
70915503|NCT05046132|141321258|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-1.9|1.4||||||16 hr post dose||1.4|-1.9|
70915504|NCT05046132|141321258|OTHER||LS Mean|2.3|||||TWO_SIDED|90.0|-0.2|4.9||||||24 hr post dose||4.9|-0.2|
70915505|NCT00208507|141321272|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This was a non-inferiority test of the Harris Hip Score means at 24+ months with a 5 point non-inferiority margin.|Mean Difference (Final Values)|0.61||||0.001|ONE_SIDED|95.0|-1.56||||ANCOVA|Preoperative Harris Hip score was included in the ANCOVA model as the only covariate.|||||-1.56|0.001
70915506|NCT00982033|141321276|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANCOVA|||||||0.90
70915507|NCT01183780|141321278|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.844||||0.0219|TWO_SIDED|95.0|0.73|0.976|||Log Rank|The analysis was performed on stratified data.|The estimation was performed on stratified data.|||0.976|0.730|0.0219
70915508|NCT01183780|141321279|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.793||||0.0005|TWO_SIDED|95.0|0.697|0.903|||Log Rank|Analysis was performed on stratified data.|Analysis was performed on stratified data.|||0.903|0.697|0.0005
70915509|NCT01183780|141321280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6336|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.6336
70915510|NCT04567888|141321339|SUPERIORITY||Slope|-1.41|||<|0.001|TWO_SIDED|95.0|-1.88|-0.95||Threshold for statistical significance set to .050.|Repeated-measures Multilevel Models|||||-0.95|-1.88|<.001
70915511|NCT04567888|141321340|SUPERIORITY||Slope|-0.54|||<|0.001|TWO_SIDED|95.0|-0.78|-0.3||Threshold for statistical significance was set to .050.|Repeated-measures Multilevel Models|||||-0.30|-0.78|< .001
70915512|NCT00371566|141321351|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7|STANDARD_DEVIATION|1.93||0.394||95.0|-5.5|2.19|||ANCOVA|Null hypothesis or reject it in favor of the two sided alternative hypothesis||The study was designed to provide evidence to support the null hypothesis: Delta equals 0% or reject it in favor of the two sided alternative hypothesis: Delta does not equal 0%, where Delta was the difference in the true response rate for the two treatment groups.||2.19|-5.50|.394
70915513|NCT01544062|141321412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.7||||0.024|TWO_SIDED|95.0|2.3|31.1|||t-test, 2 sided|||||31.1|2.3|0.024
70915514|NCT01544062|141321412|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.013
70915515|NCT01544062|141321413|SUPERIORITY_OR_OTHER|||||||0.059|TWO_SIDED||||||t-test, 2 sided|||||||0.059
70915516|NCT01544062|141321413|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.020
70915517|NCT01544062|141321414|SUPERIORITY_OR_OTHER|||||||0.724|TWO_SIDED||||||t-test, 2 sided|||||||0.724
70915518|NCT01544062|141321414|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.510
70915519|NCT01544062|141321415|SUPERIORITY_OR_OTHER|||||||0.397|TWO_SIDED||||||t-test, 2 sided|||||||0.397
70915520|NCT01544062|141321415|SUPERIORITY_OR_OTHER|||||||0.458|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.458
70915521|NCT01544062|141321416|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||t-test, 2 sided|||||||0.600
70915522|NCT01544062|141321416|SUPERIORITY_OR_OTHER|||||||0.509|TWO_SIDED||||||ANCOVA|controlling for age, sex and body mass index||||||0.509
70915523|NCT01544062|141321417|SUPERIORITY_OR_OTHER|||||||0.399|TWO_SIDED||||||t-test, 2 sided|||||||0.399
70915524|NCT01544062|141321417|SUPERIORITY_OR_OTHER|||||||0.395|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.395
70915525|NCT01544062|141321418|SUPERIORITY_OR_OTHER|||||||0.771|TWO_SIDED||||||t-test, 2 sided|||||||0.771
70915526|NCT01544062|141321418|SUPERIORITY_OR_OTHER|||||||0.927|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.927
70915527|NCT01544062|141321419|SUPERIORITY_OR_OTHER|||||||0.644|TWO_SIDED||||||t-test, 2 sided|||||||0.644
70915528|NCT01544062|141321419|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.160
70915529|NCT01544062|141321420|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||t-test, 2 sided|||||||0.710
70915530|NCT01544062|141321420|SUPERIORITY_OR_OTHER|||||||0.475|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.475
70915531|NCT01544062|141321421|SUPERIORITY_OR_OTHER|||||||0.508|TWO_SIDED||||||t-test, 2 sided|||||||0.508
70915532|NCT01544062|141321421|SUPERIORITY_OR_OTHER|||||||0.905|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.905
70915533|NCT01544062|141321422|SUPERIORITY_OR_OTHER|||||||0.104|TWO_SIDED||||||t-test, 2 sided|||||||0.104
70915534|NCT01544062|141321423|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Fisher Exact|||||||0.580
70915535|NCT01544062|141321424|SUPERIORITY_OR_OTHER|||||||0.619|TWO_SIDED||||||Fisher Exact|||||||0.619
70915536|NCT01544062|141321425|SUPERIORITY_OR_OTHER|||||||0.511|TWO_SIDED||||||Fisher Exact|||||||0.511
70915537|NCT01544062|141321426|SUPERIORITY_OR_OTHER|||||||0.501|TWO_SIDED||||||Fisher Exact|||||||0.501
70915538|NCT01544062|141321427|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.000
70915539|NCT01544062|141321428|SUPERIORITY_OR_OTHER|||||||0.299|TWO_SIDED||||||Fisher Exact|||||||0.299
70915540|NCT01544062|141321429|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.000
70915541|NCT01544062|141321430|SUPERIORITY_OR_OTHER|||||||0.492|TWO_SIDED||||||Fisher Exact|||||||0.492
70915542|NCT01544062|141321431|SUPERIORITY_OR_OTHER|||||||0.455|TWO_SIDED||||||Fisher Exact|||||||0.455
70915543|NCT01544062|141321432|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.000
70915544|NCT01123083|141321533|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.051|TWO_SIDED|95.0|-0.17|0.0|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline C-peptide AUC. Confidence Interval, not adjusted for multiple comparisons.|||0.00|-0.17|0.051
70915545|NCT01123083|141321534|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.022|TWO_SIDED|95.0|-0.18|-0.02|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline C-peptide AUC. Confidence Interval, not adjusted for multiple comparisons.|Week 12||-0.02|-0.18|0.022
70915546|NCT01123083|141321534|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.191|TWO_SIDED|95.0|-0.15|0.03|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline C-peptide AUC. Confidence Interval, not adjusted for multiple comparisons.|Month 6||0.03|-0.15|0.191
70915547|NCT01123083|141321536|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.912|TWO_SIDED|95.0|0.5|3.37|||GEE Model||Estimated treatment group difference, adjusted for age, region and Baseline HbA1c/Insulin Use Response. Confidence Interval, not adjusted for multiple comparisons.|Week 12||3.37|0.50|0.912
70915548|NCT01123083|141321536|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.912|TWO_SIDED|95.0|0.37|2.42|||GEE Model||Estimated treatment group difference, adjusted for age, region and Baseline HbA1c/Insulin Use Response. Confidence Interval, not adjusted for multiple comparisons.|Month 6||2.42|0.37|0.912
70915549|NCT01123083|141321536|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.412|TWO_SIDED|95.0|0.54|4.52|||GEE Model||Estimated treatment group difference, adjusted for age, region and Baseline HbA1c/Insulin Use Response. Confidence Interval, not adjusted for multiple comparisons.|Month 12||4.52|0.54|0.412
70915550|NCT01123083|141321537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.21|TWO_SIDED|95.0|-0.08|0.02|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline Mean Daily Insulin Use. Confidence Interval, not adjusted for multiple comparisons.|Week 12||0.02|-0.08|0.210
70915551|NCT01123083|141321537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.21|TWO_SIDED|95.0|-0.11|0.02|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline Mean Daily Insulin Use. Confidence Interval, not adjusted for multiple comparisons.|Month 6||0.02|-0.11|0.210
70915552|NCT01123083|141321537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.402|TWO_SIDED|95.0|-0.05|0.13|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline Mean Daily Insulin Use. Confidence Interval, not adjusted for multiple comparisons.|Month 12||0.13|-0.05|0.402
70915553|NCT01123083|141321538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.582|TWO_SIDED|95.0|-0.52|0.16|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and baseline HbA1c. Confidence Interval, not adjusted for multiple comparisons.|Week 12||0.16|-0.52|0.582
70915554|NCT01123083|141321538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.987|TWO_SIDED|95.0|-0.46|0.45|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and baseline HbA1c. Confidence Interval, not adjusted for multiple comparisons.|Month 6||0.45|-0.46|0.987
70915555|NCT01123083|141321538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13||||0.572|TWO_SIDED|95.0|-0.33|0.59|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and baseline HbA1c. Confidence Interval, not adjusted for multiple comparisons.|Month 12||0.59|-0.33|0.572
70915556|NCT01123083|141321541|SUPERIORITY_OR_OTHER|||||||0.452|||||||Hochberg-adjusted p-value|||Month 6||||0.452
70915557|NCT01123083|141321541|SUPERIORITY_OR_OTHER|||||||0.452|||||||Hochberg-adjusted p-value|||Month 12||||0.452
70915558|NCT01123083|141321542|SUPERIORITY_OR_OTHER|||||||0.123|||||||Hochberg-adjusted p-value|||Month 6||||0.123
70915559|NCT01123083|141321542|SUPERIORITY_OR_OTHER|||||||0.373|||||||Hochberg-adjusted p-value|||Month 12||||0.373
70915560|NCT02729701|141321544|OTHER|||||||0.017||||||a priori threshold for statistical significance \<0.05|Wilcoxon (Mann-Whitney)|||Test for within-group change by paired two-sample non-parametric test||||0.017
70915561|NCT02729701|141321545|OTHER|||||||0.043||||||a priori threshold for statistical significance \<0.05|Wilcoxon (Mann-Whitney)|2-sided||Test for within-group change via paired, two-sample non-parametric test||||0.043
70915562|NCT02729701|141321546|OTHER|||||||0.088||||||a priori threshold for statistical significance \< 0.05|Wilcoxon (Mann-Whitney)|||Test for within-group change using paired two-sample non-parametric etst||||0.088
70915563|NCT01616654|141321620|SUPERIORITY||Percentage difference|13.115||||0.096|TWO_SIDED|95.0|-3.266|29.495|||Cochran-Mantel-Haenszel|||The 95% confidence interval on the difference between Vehicle and the specified treatment group success rates was based on normal approximation with continuity correction.||29.495|-3.266|0.096
70915564|NCT01616654|141321620|SUPERIORITY||Percentage difference|16.393||||0.04|TWO_SIDED|95.0|-0.249|33.036|||Cochran-Mantel-Haenszel|||The 95% confidence interval on the difference between Vehicle and the specified treatment group success rates was based on normal approximation with continuity correction||33.036|-0.249|0.040
70915565|NCT01616654|141321620|SUPERIORITY||Percentage difference|10.273||||0.184|TWO_SIDED|95.0|-5.923|26.47|||Cochran-Mantel-Haenszel|||The 95% confidence interval on the difference between Vehicle and the specified treatment group success rates was based on normal approximation with continuity correction.||26.470|-5.923|0.184
70915566|NCT01616654|141321620|SUPERIORITY||Percentage difference|16.393||||0.041|TWO_SIDED|95.0|-0.249|33.036|||Cochran-Mantel-Haenszel|||The 95% confidence interval on the difference between Vehicle and the specified treatment group success rates was based on normal approximation with continuity correction.||33.036|-0.249|0.041
70915567|NCT01616654|141321621|SUPERIORITY||Percentage difference|-6.74||||0.108|TWO_SIDED|95.0|-14.96|1.48|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) with terms for treatment, stratum, and Baseline lesion count as covariate.||1.48|-14.96|0.108
70915568|NCT01616654|141321621|SUPERIORITY||Percentage difference|-7.88||||0.06|TWO_SIDED|95.0|-16.11|0.34|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) with terms for treatment, stratum, and Baseline lesion count as covariate.||0.34|-16.11|0.060
70915569|NCT01616654|141321621|SUPERIORITY||Percentage difference|-8.11||||0.054|TWO_SIDED|95.0|-16.35|0.13|||ANCOVA|||Analysis was performed using ANCOVA with terms for treatment, stratum, treatment stratum, and with Baseline lesion count as covariate.||0.13|-16.35|0.054
70915570|NCT01616654|141321621|SUPERIORITY||Percentage difference|-12.97||||0.002|TWO_SIDED|95.0|-21.18|-4.76|||ANCOVA|||Analysis was performed using ANCOVA with terms for treatment, stratum, treatment stratum, and with Baseline lesion count as covariate.||-4.76|-21.18|0.002
70915571|NCT01616654|141321622|SUPERIORITY|||||||0.067|||||||Cochran-Mantel-Haenszel|||||||0.067
70915572|NCT01616654|141321622|SUPERIORITY|||||||0.054|||||||Cochran-Mantel-Haenszel|||||||0.054
70915573|NCT01616654|141321622|SUPERIORITY|||||||0.038|||||||Cochran-Mantel-Haenszel|||||||0.038
70915574|NCT01616654|141321622|SUPERIORITY|||||||0.003|||||||Cochran-Mantel-Haenszel|||||||0.003
70915575|NCT02057692|141321626|SUPERIORITY||LS mean difference|-0.889|STANDARD_ERROR_OF_MEAN|0.3969||0.0321|TWO_SIDED|95.0|-1.698|0.081|||ANCOVA|||The primary analysis of change from baseline to endpoint (Week 13/ET) average daily ItchRO(Obs) was evaluated by analysis of covariance (ANCOVA) using a PROC MIXED procedure. Least-squares (LS) mean change from baseline to Endpoint (Week 13/ET), along with associated 95% confidence interval (CI) for the LS mean, and pair-wise treatment P-values were calculated for each treatment group.||0.081|-1.698|0.0321
70915576|NCT02057692|141321626|SUPERIORITY||LS mean difference|-0.906|STANDARD_ERROR_OF_MEAN|0.3503||0.0145|TWO_SIDED|95.0|-1.62|-0.192|||ANCOVA|||The primary analysis of change from baseline to endpoint (Week 13/ET) average daily ItchRO(Obs) was evaluated by ANCOVA using a PROC MIXED procedure. LS mean change from baseline to Endpoint (Week 13/ET), along with associated 95% CI for the LS mean, and pair-wise treatment P-values were calculated for each treatment group.||-0.192|-1.620|0.0145
70915577|NCT02057692|141321626|SUPERIORITY||LS mean difference|-0.039|STANDARD_ERROR_OF_MEAN|0.4431||0.9298|TWO_SIDED|95.0|-0.942|0.863|||ANCOVA|||The primary analysis of change from baseline to endpoint (Week 13/ET) average daily ItchRO(Obs) was evaluated by ANCOVA using a PROC MIXED procedure. LS mean change from baseline to Endpoint (Week 13/ET), along with associated 95% confidence interval (CI) for the LS mean, and pair-wise treatment P-values were calculated for each treatment group.||0.863|-0.942|0.9298
70915578|NCT00864682|141321631|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Kruskal-Wallis|||Hypothesis: Lidocaine / propofol admixture would be superior to lidocaine pretreatment for attenuating propofol-induced injection pain. Sample size calculated to detect a difference of at least 2 VPS points; beta 0.8.||||<0.0001
70915579|NCT00864682|141321632|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.008||95.0|||||Chi-squared|Fisher's exact test after chi-squared||||||<0.008
70915580|NCT05372094|141321634|OTHER|||||||0.007|||||||Mixed Models Analysis|||Fixed factor of program and random intercept of participant||||0.007
70915581|NCT05372094|141321634|OTHER||||||<|0.05|||||||Mixed Models Analysis|||Follow up comparison between noise reduction setting OFF and noise reduction setting STRONG||||< 0.05
70915582|NCT05372094|141321634|OTHER||||||<|0.01|||||||Mixed Models Analysis|||Follow up comparison between noise reduction setting STRONG and noise reduction setting WEAK||||<0.01
70915583|NCT05372094|141321634|OTHER||||||>|0.05|||||||Mixed Models Analysis|||"Follow up comparison between ratings of effort with OFF and WEAK"||||>.05
70915584|NCT05372094|141321635|OTHER|||||||0.283|||||||Mixed Models Analysis|||||||0.283
70915585|NCT05372094|141321636|OTHER|||||||0.145|||||||Mixed Models Analysis|||Analysis was done only between NR OFF and NR at a custom or preferred setting.||||0.145
70915586|NCT05372094|141321637|OTHER|||||||0.3018|||||||Exact Binomial test|||An exact binomial test was performed to evaluate if the majority of teens and pre-teens with mild to severe hearing loss preferred NR setting (i.e., either weak or strong) to the NR setting OFF.||||0.3018
70915587|NCT05372094|141321638|OTHER|||||||0.1796|||||||Exact Binomial test|||Exact binomial test was done to evaluate if the majority (\>50%) of teens and pre-teens prefer to use Tap Control to access Bluetooth streaming, compared to using the HA push button or phone controls.||||0.1796
70970726|NCT00609791|141447165|SUPERIORITY||Mean Difference (Final Values)|1.68||||0.75|TWO_SIDED|95.0|-9.3|12.7|||t-test, 2 sided|||Difference in age based on whether a participant experienced grade 3 toxicity.||12.7|-9.3|0.75
70915588|NCT02393716|141321640|OTHER|Single arm study with a hypothesis test comparing to performance goal|Percentage|2.9|||<|0.001|ONE_SIDED|97.5||7.2|||Based on exact binomial distribution|||"The primary safety endpoint was tested against a predetermined safety Performance Goal (PG) using the following statistical hypotheses:~H0: p ≥ 20% vs. H1: p \< 20% where p is the proportion of subjects experiencing a MAE within 30 days of the index procedure in the target population of subjects treated with the Endurant Evo AAA Stent graft system and 20% is the safety PG."||7.2||<0.001
70915589|NCT02393716|141321641|OTHER|Single-arm study with a hypothesis test comparing to performance goal|Percentage|95.8|||<|0.001|ONE_SIDED|97.5|90.4||||Based on exact binomial distribution|||"The primary effectiveness endpoint was tested against a predetermined effectiveness PG using following statistical hypotheses:~H0: q ≤ 80% vs. H1: q \> 80% where q is the proportion of subjects who have a successful aneurysm treatment in the target population of subjects treated with the Endurant Evo AAA Stent graft system and 80% is the effectiveness PG."|||90.4|<0.001
70915590|NCT00470106|141321722|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Not corrected for multiple comparisons because it is primary.|mixed model|same analysis as for secondary outcome variable.||||||<.001
70915591|NCT00470106|141321723|SUPERIORITY_OR_OTHER||||||<|0.1||||||A priori threshold for significance was P \< .05|mixed model|Same as for the primary variable.||||||<.10
70915592|NCT00758602|141321725|SUPERIORITY_OR_OTHER||LS Mean difference|0.6581||||0.0813|TWO_SIDED|95.0|-0.08|1.4||p-value, least squares (LS) mean difference, and 95% confidence interval (CI) based on analysis of covariance (ANCOVA) model with treatment, center, and the treatment-by-center interaction as fixed effects, and the donor age as a covariate.|ANCOVA|||||1.40|-0.08|0.0813
70915593|NCT00758602|141321726|SUPERIORITY_OR_OTHER||LS Mean difference|-1.5977||||0.7949|TWO_SIDED|95.0|-13.77|10.58||p-value, LS mean difference, and 95% CI based on ANCOVA model with treatment, center, and the treatment-by-center interaction as fixed effects, and the donor age as a covariate.|ANCOVA|||||10.58|-13.77|0.7949
70915594|NCT00758602|141321727|SUPERIORITY_OR_OTHER|||||||0.6812|||||||Fisher Exact|||Acute rejection, 6 months post-transplant||||0.6812
70915595|NCT00758602|141321727|SUPERIORITY_OR_OTHER|||||||0.6812|||||||Fisher Exact|||Acute rejection, 12 months post-transplant||||0.6812
70915596|NCT00758602|141321727|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Death, 12 months post-transplant||||1.0000
70915597|NCT00758602|141321729|SUPERIORITY_OR_OTHER|||||||1|||||||Log Rank|||||||1.0000
70915598|NCT00758602|141321730|SUPERIORITY_OR_OTHER|||||||0.4586|||||||Fisher Exact|||||||0.4586
70915599|NCT00758602|141321731|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
70915600|NCT04365400|141321770|SUPERIORITY||Hodges Lehmann Median|8.24||||0.1148124|TWO_SIDED|95.0|-2.01|18.19|||Wilcoxon (Mann-Whitney)|||||18.19|-2.01|0.1148124
70915601|NCT04365400|141321770|SUPERIORITY||Hodges Lehmann Median|-0.82||||0.8668467|TWO_SIDED|95.0|-10.16|7.96|||Wilcoxon (Mann-Whitney)|||||7.96|-10.16|0.8668467
70915602|NCT04365400|141321771|SUPERIORITY||Difference in Change in HbA1c (%)|0.02516||||0.8658|TWO_SIDED|95.0|-0.26658|0.316897|||ANCOVA|||||0.316897|-0.26658|0.8658
70915603|NCT04365400|141321771|SUPERIORITY||Difference in Change in HbA1c (%)|-0.07333||||0.65|TWO_SIDED|95.0|-0.39012|0.243455|||ANCOVA|||||0.243455|-0.39012|0.6500
70915604|NCT02371746|141321786|SUPERIORITY||Change from baseline|30.4|STANDARD_DEVIATION|1.84|<|0.001|TWO_SIDED|95.0|-1.8|36.6|||ANCOVA|||estimatCohort 1 all Groups: Non-study eye: TRAVANTAN Z Cohort 1 - Group 1: Study Eye: 28.2 ug travoprost Cohort 1 - Group 2: Study Eye: 42.3 ug travoprost Cohort 1 - Group 3: Study Eye: 42 .5 ug travoprost Cohort 1 - Group 4: Study Eye: 85.0 ug travoprost||36.6|-1.8|<0.001
70915605|NCT01490580|141321813|SUPERIORITY||Risk Difference (RD)|-6.4||||0.38|TWO_SIDED|95.0|-21.0|8.1|||Mixed Models Analysis|||||8.1|-21.0|0.38
70915606|NCT02950558|141321911|OTHER|||||||0.1269|||||||Wilcoxon (Mann-Whitney)|||||||0.1269
70915607|NCT02950558|141321912|OTHER|||||||0.8808|||||||Wilcoxon (Mann-Whitney)|||||||0.8808
70915608|NCT02950558|141321913|OTHER|||||||0.0382|||||||Wilcoxon (Mann-Whitney)|||||||0.0382
70915609|NCT02950558|141321914|OTHER|||||||0.4696|||||||Wilcoxon (Mann-Whitney)|||||||0.4696
70915610|NCT02950558|141321915|OTHER|||||||0.1818|||||||Fisher Exact|||||||0.1818
70915611|NCT02914522|141321923|SUPERIORITY||Difference in Percentages|10.8||||0.0157|TWO_SIDED|95.0|2.1|19.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH) test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and immunomodulators (Yes/No) at Day 1.||||19.5|2.1|0.0157
70915612|NCT02914522|141321923|SUPERIORITY||Difference in Percentages|3.8||||0.3379|TWO_SIDED|95.0|-4.3|12.0|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||12.0|-4.3|0.3379
70915613|NCT02914522|141321923|SUPERIORITY||Difference in Percentages|7.2||||0.0103|TWO_SIDED|95.0|1.6|12.8|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||12.8|1.6|0.0103
70915614|NCT02914522|141321923|SUPERIORITY||Difference in Percentages|5.2||||0.0645|TWO_SIDED|95.0|0.0|10.5|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||10.5|-0.0|0.0645
70915615|NCT02914522|141321924|SUPERIORITY||Difference in Percentages|26.0|||<|0.0001|TWO_SIDED|95.0|16.0|35.9|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||35.9|16.0|< 0.0001
70915616|NCT02914522|141321924|SUPERIORITY||Difference in Percentages|10.4||||0.042|TWO_SIDED|95.0|0.0|20.7|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||20.7|-0.0|0.0420
70915617|NCT02914522|141321925|SUPERIORITY||Difference in Percentages|12.1||||0.0053|TWO_SIDED|95.0|3.8|20.4|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||20.4|3.8|0.0053
70915618|NCT02914522|141321925|SUPERIORITY||Difference in Percentages|4.6||||0.2295|TWO_SIDED|95.0|-3.1|12.2|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||12.2|-3.1|0.2295
70970727|NCT00609791|141447165|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.13|TWO_SIDED|95.0|-0.12|0.81|||t-test, 2 sided|||Difference in AUC based on whether a participant experienced grade 3 toxicity.||0.81|-0.12|0.13
70915619|NCT02914522|141321925|SUPERIORITY||Difference in Percentages|5.3||||0.0393|TWO_SIDED|95.0|-0.1|10.7|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||10.7|-0.1|0.0393
70915620|NCT02914522|141321925|SUPERIORITY||Difference in Percentages|1.7||||0.5308|TWO_SIDED|95.0|-3.1|6.6|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||6.6|-3.1|0.5308
70915621|NCT02914522|141321926|SUPERIORITY||Difference in Percentages|8.6||||0.0047|TWO_SIDED|95.0|2.9|14.3|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||14.3|2.9|0.0047
70915622|NCT02914522|141321926|SUPERIORITY||Difference in Percentages|2.1||||0.3495|TWO_SIDED|95.0|-2.6|6.8|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||6.8|-2.6|0.3495
70915623|NCT02914522|141321926|SUPERIORITY||Difference in Percentages|1.3||||0.4269|TWO_SIDED|95.0|-2.5|5.1|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||5.1|-2.5|0.4269
70915624|NCT02914522|141321926|SUPERIORITY||Difference in Percentages|0.0||||0.9987|TWO_SIDED|95.0|-3.4|3.4|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||3.4|-3.4|0.9987
71092970|NCT04153864|141692736|NON_INFERIORITY|The NIM was defined as 13% of the mean EPDS score in the In-Person group (8.92), which corresponded to a value of 1.16. This predetermined NIM of 13% aligns with noninferiority guidelines and ensures clinically meaningful conclusions.|Mean Difference (Final Values)|0.23|||<|0.05|ONE_SIDED|95.0||0.77|||t-test, 1 sided|||Behavioral Activation (BA) delivered via Telemedicine will be non-inferior to BA delivered In-Person if the upper limit of the 95% confidence interval for the estimated mean difference in EPDS scores is less than the pre-specified 13% non-inferiority margin (NIM). Please note, this presents the Intention to Treat (ITT) analysis.||0.77||<0.05
70915625|NCT02914522|141321927|SUPERIORITY||Difference in Percentages|19.0|||<|0.0001|TWO_SIDED|95.0|9.9|28.2|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||28.2|9.9|<0.0001
70915626|NCT02914522|141321927|SUPERIORITY||Difference in Percentages|7.8||||0.0672|TWO_SIDED|95.0|-0.7|16.2|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||16.2|-0.7|0.0672
70915627|NCT02914522|141321927|SUPERIORITY||Difference in Percentages|11.4||||0.0019|TWO_SIDED|95.0|4.2|18.6|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||18.6|4.2|0.0019
70915628|NCT02914522|141321927|SUPERIORITY||Difference in Percentages|5.2||||0.1286|TWO_SIDED|95.0|-1.4|11.8|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||11.8|-1.4|0.1286
70915629|NCT02914522|141321928|SUPERIORITY||Difference in Percentages|7.9||||0.0105|TWO_SIDED|95.0|1.9|13.8|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1||||13.8|1.9|0.0105
71153910|NCT00488683|141800065|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.04||||0.7||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup A||||0.70
70915630|NCT02914522|141321928|SUPERIORITY||Difference in Percentages|4.3||||0.1062|TWO_SIDED|95.0|-1.0|9.6|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1||||9.6|-1.0|0.1062
70915631|NCT02914522|141321928|SUPERIORITY||Difference in Percentages|1.7||||0.3084|TWO_SIDED|95.0|-2.2|5.6|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||5.6|-2.2|0.3084
70915632|NCT02914522|141321928|SUPERIORITY||Difference in Percentages|0.0||||0.9109|TWO_SIDED|95.0|-3.4|3.4|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||3.4|-3.4|0.9109
70915633|NCT02914522|141321934|SUPERIORITY||Difference in Percentages|25.5|||<|0.0001|TWO_SIDED|95.0|16.0|35.0|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||35.0|16.0|<0.0001
70915634|NCT02914522|141321934|SUPERIORITY||Difference in Percentages|9.2||||0.0658|TWO_SIDED|95.0|-1.1|19.5|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||19.5|-1.1|0.0658
70915635|NCT02914522|141321935|SUPERIORITY||Difference in Percentages|13.0||||0.0024|TWO_SIDED|95.0|5.3|20.6|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||20.6|5.3|0.0024
70915636|NCT02914522|141321935|SUPERIORITY||Difference in Percentages|0.9||||0.7951|TWO_SIDED|95.0|-7.0|8.7|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||8.7|-7.0|0.7951
70915637|NCT02914522|141321936|SUPERIORITY||Difference in Percentages|20.8||||0.0055|TWO_SIDED|95.0|7.7|33.9|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||33.9|7.7|0.0055
70915638|NCT02914522|141321936|SUPERIORITY||Difference in Percentages|8.2||||0.1265|TWO_SIDED|95.0|-4.2|20.6|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||20.6|-4.2|0.1265
70915639|NCT02914522|141321937|SUPERIORITY||Difference in Percentages|9.5||||0.0157|TWO_SIDED|95.0|1.8|17.1|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||17.1|1.8|0.0157
70915640|NCT02914522|141321937|SUPERIORITY||Difference in Percentages|5.5||||0.1808|TWO_SIDED|95.0|-2.9|13.9|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||13.9|-2.9|0.1808
70915641|NCT02914522|141321938|SUPERIORITY||Difference in Percentages|24.9|||<|0.0001|TWO_SIDED|95.0|14.6|35.2|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||35.2|14.6|<0.0001
70915642|NCT02914522|141321938|SUPERIORITY||Difference in Percentages|9.9||||0.0521|TWO_SIDED|95.0|-1.3|21.2|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||21.2|-1.3|0.0521
70915643|NCT02914522|141321939|SUPERIORITY||Difference in Percentages|16.0||||0.0005|TWO_SIDED|95.0|7.8|24.2|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||24.2|7.8|0.0005
70915644|NCT02914522|141321939|SUPERIORITY||Difference in Percentages|4.3||||0.2946|TWO_SIDED|95.0|-3.9|12.6|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||12.6|-3.9|0.2946
70915645|NCT05382104|141321956|EQUIVALENCE|A linear mixed-effects model was applied to natural log (ln)-transformed Cmax with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90 percent (%) confidence intervals (CIs) was constructed for the differences between Treatment B versus Treatment A. The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment B versus Treatment A.|Geometric Mean Ratio (%)|76.62|||||TWO_SIDED|90.0|71.78|81.78|||||Geometric mean ratio (%) was calculated as 100\*(Treatment B / Treatment A).|||81.78|71.78|
70915646|NCT05382104|141321956|EQUIVALENCE|A linear mixed-effects model was applied to ln-transformed Cmax with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs was constructed for differences between Treatment C versus Treatment A. The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment C versus Treatment A.|Geometric Mean Ratio (%)|71.61|||||TWO_SIDED|90.0|67.14|76.37|||||Geometric mean ratio (%) was calculated as 100\*(Treatment C / Treatment A).|||76.37|67.14|
70915647|NCT05382104|141321957|EQUIVALENCE|A linear mixed-effects model was applied to ln-transformed AUClast with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs was constructed for the differences between Treatment B versus Treatment A. The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment B versus Treatment A.|Geometric Mean Ratio (%)|84.13|||||TWO_SIDED|90.0|80.74|87.66|||||Geometric mean ratio (%) was calculated as 100\*(Treatment B / Treatment A).|||87.66|80.74|
70915648|NCT05382104|141321957|EQUIVALENCE|A linear mixed-effects model was applied to ln-transformed AUClast with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs was constructed for differences between Treatment C versus Treatment A. The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment C versus Treatment A.|Geometric Mean Ratio (%)|87.35|||||TWO_SIDED|90.0|83.87|90.96|||||Geometric mean ratio (%) was calculated as 100\*(Treatment C / Treatment A).|||90.96|83.87|
70915649|NCT05382104|141321958|EQUIVALENCE|A linear mixed-effects model was applied to ln-transformed AUC0-infinity with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs was constructed for the differences between Treatment B versus Treatment A. The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment B versus Treatment A.|Geometric Mean Ratio (%)|84.74|||||TWO_SIDED|90.0|81.28|88.34|||||Geometric mean ratio (%) was calculated as 100\*(Treatment B / Treatment A).|||88.34|81.28|
70915650|NCT05382104|141321958|EQUIVALENCE|A linear mixed-effects model was applied to ln-transformed AUC0-infinity with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs was constructed for differences between Treatment C versus Treatment A. The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment C versus Treatment A.|Geometric Mean Ratio (%)|87.84|||||TWO_SIDED|90.0|84.3|91.53|||||Geometric mean ratio (%) was calculated as 100\*(Treatment C / Treatment A).|||91.53|84.30|
70915651|NCT03506880|141321964|SUPERIORITY||Mean Difference (Final Values)|0.17|||>|0.05|TWO_SIDED||||||Tukey's Post-Hoc||Estimation parameter used to determine significance between mean values in MADD, SG, and AC group.|It was hypothesized that drinking would increase from baseline to 12-month follow-up for those in the AC, but not for those in the SG and MADD conditions.||||>0.05
70970728|NCT00609791|141447165|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.34|TWO_SIDED|95.0|-0.67|0.25|||t-test, 2 sided|||Difference in clearance based on whether a participant experienced grade 3 toxicity.||0.25|-0.67|0.34
70915652|NCT03506880|141321965|SUPERIORITY||Mean Difference (Final Values)|0.16|||<|0.01|TWO_SIDED||||||Tukey's Post-Hoc||Estimation parameter used to determine significance between mean values in MADD, SG, and AC group.|It was also hypothesized that teens in the SG and MADD conditions would report significantly more declining rides with impaired drivers than those in the AC group.||||<0.01
70915653|NCT03506880|141321966|SUPERIORITY||Mean Difference (Final Values)|0.06|||>|0.01|TWO_SIDED||||||Tukey's Post-Hoc||Estimation parameter used to determine significance between mean values in MADD, SG, and AC group.|It was hypothesized that participants in the MADD and SG groups would be significantly less willing to ride in a car with an impaired driver than those in the AC group.||||>0.01
70970729|NCT02484911|141447166|SUPERIORITY_OR_OTHER|||||||0.397|||||||Chi-squared|||||||0.397
70970730|NCT02484911|141447167|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.0
70970731|NCT02484911|141447169|SUPERIORITY_OR_OTHER|||||||0.397|||||||Chi-squared|||||||0.397
70970732|NCT02484911|141447170|SUPERIORITY_OR_OTHER|||||||0.02|||||||Chi-squared|||||||0.02
70915654|NCT00361283|141321989|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-111.0|STANDARD_ERROR_OF_MEAN|76.7||0.15|TWO_SIDED|95.0|-264.0|42.0||No confounders were controlled for as each person is his/her own control.|t-test, 2 sided|||The study in healthy volunteers was to compare levels at baseline to 16 weeks in ENA-78, a cytokine. The one sample t-test was used to obtain the result.||42|-264|0.15
70915655|NCT00482729|141322022|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|||<|0.001||95.0|-0.78|-0.43|||ANCOVA|Model terms: treatment, baseline A1C||||-0.43|-0.78|<0.001
70915656|NCT00482729|141322023|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.07|||<|0.001||95.0|1.6|2.69||Based on a test of the odds ratio = 1, comparing the odds of having A1C \<7.0% at Week 18 in the Sita/Met FDC group vs. the Metformin group.|ANCOVA|Model terms: treatment, baseline A1C|This parameter estimate and 95% confidence interval correspond to the odds of having A1C \<7.0% at Week 18 in the Sita/Met FDC group vs. the Metformin group.|||2.69|1.60|<0.001
70915657|NCT00482729|141322024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.7|||<|0.001||95.0|-22.4|-9.0|||ANCOVA|Model terms: treatment, baseline A1C||||-9.0|-22.4|<0.001
70915658|NCT00482729|141322025|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48||||||95.0|-0.67|-0.3|||||This is a difference in least squares means, based on an ANCOVA model with terms for treatment and baseline (i.e., Week 0) A1C.|||-0.30|-0.67|
70915659|NCT00482729|141322026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.11||||||95.0|1.63|2.73|||||This parameter estimate and 95% confidence interval correspond to the odds of having A1C \<7.0% at Week 44 in the Sita/Met FDC group vs. the Metformin group, based on a logistic regression model with terms for treatment and baseline (i.e., Week 0) A1C|||2.73|1.63|
70915660|NCT01606124|141322027|SUPERIORITY|||||||0.5631|||||||Wilcoxon (Mann-Whitney)|||||||0.5631
70915661|NCT01606124|141322028|SUPERIORITY|||||||0.1439|||||||Wilcoxon (Mann-Whitney)|||||||0.1439
70915662|NCT02525796|141322086|SUPERIORITY||Median Difference (Net)|3.2||||0.84|TWO_SIDED||||||ANOVA|||ANOVA comparing the change in PTH over 4 weeks between eplerenone monotherapy and placebo||||0.84
70915663|NCT02525796|141322086|SUPERIORITY||Median Difference (Net)|4.5||||0.54|TWO_SIDED||||||ANOVA|||ANOVA comparing the change in PTH over 4 weeks between amiloride monotherapy and placebo||||0.54
70915664|NCT02525796|141322086|SUPERIORITY||Median Difference (Net)|7.6||||0.58|TWO_SIDED||||||ANOVA|||ANOVA comparing the change in PTH over 4 weeks between eplerenone monotherapy and amiloride monotherapy||||0.58
70915665|NCT02525796|141322087|SUPERIORITY||Median Difference (Net)|0.0||||0.82|TWO_SIDED||||||ANOVA|||ANOVA comparing the change in serum calcium over 4 weeks between eplerenone monotherapy and placebo||||0.82
70915666|NCT02525796|141322087|SUPERIORITY||Median Difference (Net)|0.1||||0.21|TWO_SIDED||||||ANOVA|||ANOVA comparing the change in serum calcium over 4 weeks between amiloride monotherapy and placebo||||0.21
70915667|NCT02525796|141322087|SUPERIORITY||Median Difference (Net)|0.1||||0.12|TWO_SIDED||||||ANOVA|||ANOVA comparing the change in serum calcium over 4 weeks between eplerenone monotherapy and amiloride monotherapy||||0.12
70915668|NCT00955825|141322097|SUPERIORITY_OR_OTHER||LS Mean difference vs. Placebo|-0.126||||0.0003||95.0|-0.194|-0.058|||ANCOVA||Relative LS Means difference (%) = - 28.24|||-0.058|-0.194|0.0003
70915669|NCT01499134|141322098|SUPERIORITY_OR_OTHER|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
70915670|NCT01499134|141322099|SUPERIORITY_OR_OTHER|||||||0.585|||||||Wilcoxon (Mann-Whitney)|||||||0.585
70915671|NCT01499134|141322100|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||This p-value is correct, confirmed with report from statistician.|Wilcoxon (Mann-Whitney)|||||||1.000
70915672|NCT01499134|141322101|SUPERIORITY_OR_OTHER|||||||0.363|||||||Wilcoxon (Mann-Whitney)|||||||0.363
70915673|NCT01499134|141322102|SUPERIORITY_OR_OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||||||0.017
70915674|NCT01499134|141322103|SUPERIORITY_OR_OTHER|||||||0.476|||||||Wilcoxon (Mann-Whitney)|||||||0.476
70915675|NCT01499134|141322104|SUPERIORITY_OR_OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.170
70915676|NCT01499134|141322105|SUPERIORITY_OR_OTHER|||||||0.595|||||||Wilcoxon (Mann-Whitney)|||||||0.595
70915677|NCT01198275|141322111|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.441|||<|0.05|TWO_SIDED|95.0|0.292|0.666|||Kaplan Meyer analysis|The time to first AF recurrence was analyzed with the Kaplan-Meier method and compared with the log-rank test.|Hazard ratios between n-3 PUFA and Placebo together with confidence intervals were estimated using the Cox proportional regression model.|Give a relapse rate ranging from 40% to 60% on ACE-I/ARB and amiodarone therapy, considering the high risk of relapses in our study population we conservatively assumed a 50% relapse rate. We calculated that a total of 180 patients would yield 80% power to detect a clinically relevant difference of about 20% in AF recurrence with the addition of n-3 PUFAs at a log-rank test, with a significance level of 0.05.||0.666|0.292|< 0.05
70915678|NCT00970307|141322130|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: the upper limit of Standardised asymptotic 95% confidence interval lower or equal to 10% .|Difference in percentage|-0.76|||||TWO_SIDED|95.0|-4.21|2.22||||||||2.22|-4.21|
70915679|NCT00970307|141322131|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: the upper limit of Standardized asymptotic 95% confidence interval lower or equal to 10% .|Difference in percentage|-0.72|||||TWO_SIDED|95.0|-5.19|3.57||||||||3.57|-5.19|
70915680|NCT00738699|141322181|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.13||||0.836|TWO_SIDED|95.0|0.88|1.46||One-sided log rank test stratified by route of administration for primary chemotherapy (intraperitoneal vs intravenous) and geographic region (North America, Europe, and other participating countries).|Log Rank||Stratified as described above.|||1.46|0.88|0.8360
70915681|NCT00738699|141322182|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.11||||0.7568|TWO_SIDED|95.0|0.83|1.48||One-sided log rank test stratified by route of administration for primary chemotherapy and geographic region.|Log Rank||Stratified as described above|||1.48|0.83|0.7568
70915682|NCT00738699|141322183|SUPERIORITY_OR_OTHER||Difference|-7.4||||0.0399|TWO_SIDED|95.0|-14.1|-0.7||Compared the ratio of complete or partial responders in the two arms. Stratified by route of administration for first line therapy and geographic region as specified at baseline.|Cochran-Mantel-Haenszel||(FAR + Paclitaxel) minus (Placebo + Paclitaxel). Confidence interval based on a normal approximation to the binomial distribution.|||-0.7|-14.1|0.0399
70970733|NCT02484911|141447171|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.0
70970734|NCT02484911|141447172|SUPERIORITY_OR_OTHER|||||||0.005|||||||Chi-squared|||||||0.005
70970735|NCT02484911|141447174|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.0
70970736|NCT02484911|141447175|SUPERIORITY_OR_OTHER|||||||0.283|||||||Chi-squared|||||||0.283
70970737|NCT02484911|141447176|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.0
70915683|NCT01192542|141322194|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin of 0.05 (1/2 LogMAR line) was used.|Least-square mean difference|-0.009|STANDARD_ERROR_OF_MEAN|0.0064|||TWO_SIDED|95.0|-0.022|0.003|||Mixed Models Analysis|Comparisons between two lenses were carried out using 95% confidence intervals (CI) constructed for least-square mean differences.|The mean difference is calculated as: Test lens - Control lens.|The alternative hypothesis is the monocular visual acuity of the galyfilcon A prototype lens is non-inferior to that of the enfilcon A lens.||0.003|-0.022|
70915684|NCT01192542|141322197|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin of 0.05 (1/2 LogMAR line) was used.|Least-square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.0091|||TWO_SIDED|95.0|-0.018|0.018|||Mixed Models Analysis|Comparisons between two lenses were carried out using 95% confidence intervals (CI) constructed for least-square mean differences.||The alternative hypothesis is the binocular visual acuity of the galyfilcon A prototype lens is non-inferior to that of the enfilcon A lens.||0.018|-0.018|
70915685|NCT00355914|141322198|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|95.0||||Results were considered statistically significant if the P value was less than 0.05.|t-test, 2 sided|||compared baseline, 3, 6, 12, 18, and 24 months between groups||||>0.05
70915686|NCT00355914|141322199|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Results were considered statistically significant if the P value was less than 0.05.|t-test, 2 sided|||baseline, 3, 6, 12, 18, and 24 months between groups||||>0.05
70915687|NCT00964366|141322248|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Dunn's Multiple Comparisons Test|||||||> 0.05
70915688|NCT00964366|141322250|SUPERIORITY_OR_OTHER||||||<|0.05||||||Dapsone versus Clindamycin/BPO gel.|Dunn's Multiple Comparisons Test|||||||< 0.05
70915689|NCT00964366|141322251|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
70915690|NCT00964366|141322252|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
70915691|NCT02957539|141322260|SUPERIORITY||Mean Difference (Net)|-4.5|||||TWO_SIDED|97.5|-10.7|1.6|||||Change in weight from baseline to week 32 in the financial rewards arm minus the change in weight from baseline to week 32 in the no rewards arm.|||1.6|-10.7|
70915692|NCT02957539|141322260|SUPERIORITY||Mean Difference (Net)|-5.0|||<|0.025|TWO_SIDED|97.5|-11.1|1.0|||t-test, 2 sided||Change in weight from baseline to week 32 in the non-financial arm minus the change in weight from baseline to week 32 in the no rewards arm|||1|-11.1|<0.025
70915693|NCT02957539|141322261|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|97.5|-0.5|1.8|||||Change in Self Efficacy score from baseline to week 16 in the financial rewards arm minus the change in Self Efficacy score from baseline to week 16 in the no rewards arm.|||1.8|-0.5|
70915694|NCT02957539|141322261|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|97.5|-0.8|1.5|||||Change in Self Efficacy score from baseline to week 16 in the nonfinancial rewards arm minus the change in Self Efficacy score from baseline to week 16 in the no rewards arm.|||1.5|-0.8|
70915695|NCT02957539|141322262|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|97.5|-1.2|1.4|||||The change in self efficacy from baseline to week 32 in the financial incentive arm minus the change in self efficacy from baseline to week 32 in the no rewards arm|||1.4|-1.2|
70915696|NCT02957539|141322262|SUPERIORITY||Mean Difference (Net)|0.5|||||TWO_SIDED|97.5|-0.9|1.8|||||The change in self efficacy from baseline to week 32 in the nonfinancial incentive arm minus the change in self efficacy from baseline to week 32 in the no rewards arm|||1.8|-.9|
70915697|NCT02957539|141322263|SUPERIORITY||Mean Difference (Net)|1.5|||||TWO_SIDED|97.5|0.2|2.8|||||The change in self efficacy from baseline to week 52 in the financial incentive arm minus the change in self efficacy from baseline to week 52 in the no rewards arm|||2.8|0.2|
70915698|NCT02957539|141322263|SUPERIORITY||Mean Difference (Net)|1.2|||||TWO_SIDED|97.5|0.0|2.3|||||The change in self efficacy from baseline to week 52 in the nonfinancial incentive arm minus the change in self efficacy from baseline to week 52 in the no rewards arm|||2.3|0.0|
70915699|NCT02957539|141322264|SUPERIORITY||Mean Difference (Net)|0.2|||||TWO_SIDED|97.5|-0.4|0.9|||||Change in intrinsic motivation score from baseline to week 16 in the financial rewards arm minus the change in intrinsic motivation score from baseline to week 16 in the no rewards arm.|||0.9|-0.4|
70915700|NCT02957539|141322264|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|97.5|-0.6|0.7|||||Change in intrinsic motivation score from baseline to week 16 in the nonfinancial rewards arm minus the change in intrinsic motivation score from baseline to week 16 in the no rewards arm.|||0.7|-0.6|
70915701|NCT02957539|141322265|SUPERIORITY||Mean Difference (Net)|0.5|||||TWO_SIDED|97.5|-0.2|1.3|||||The change in intrinsic motivation from baseline to week 32 in the financial incentive arm minus the change in intrinsic motivation from baseline to week 32 in the no rewards arm|||1.3|-0.2|
70915702|NCT02957539|141322265|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|97.5|-0.3|1.6|||||The change in intrinsic motivation from baseline to week 32 in the nonfinancial incentive arm minus the change in intrinsic motivation from baseline to week 32 in the no rewards arm|||1.6|-0.3|
70915703|NCT02957539|141322266|SUPERIORITY||Mean Difference (Final Values)|0.5|||||TWO_SIDED|97.5|-0.5|1.5|||||The change in intrinsic motivation from baseline to week 52 in the financial incentive arm minus the change in intrinsic motivation from baseline to week 52 in the no rewards arm|||1.5|-0.5|
70915704|NCT02957539|141322266|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|97.5|-0.8|1.6|||||Incentive Group minus usual care|||1.6|-0.8|
70915705|NCT02957539|141322267|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|97.5|-2.0|2.6|||||Change in PHQ-8 score from baseline to week 16 in the financial rewards arm minus the change in PHQ-8 score from baseline to week 16 in the no rewards arm.|||2.6|-2.0|
70915706|NCT02957539|141322267|SUPERIORITY||Mean Difference (Net)|0.7|||||TWO_SIDED|97.5|-1.5|2.9|||||Change in PHQ-9 from week baseline to week 16 in the non-financial incentive group minus the change from week baseline to week 16 in the no rewards group|||2.9|-1.5|
70915707|NCT02957539|141322268|SUPERIORITY||Mean Difference (Net)|1.4|||||TWO_SIDED|97.5|-1.7|4.5|||||The change in PHQ-8 from baseline to week 32 in the financial incentive arm minus the change in PHQ-8 from baseline to week 32 in the no rewards arm|||4.5|-1.7|
70915708|NCT02957539|141322268|SUPERIORITY||Mean Difference (Net)|2.2|||||TWO_SIDED|97.5|-0.7|5.0|||||The change in PHQ-8 from baseline to week 32 in the nonfinancial incentive arm minus the change in PHQ-8 from baseline to week 32 in the no rewards arm|||5.0|-0.7|
70915709|NCT02957539|141322269|SUPERIORITY||Mean Difference (Net)|-1.1|||||TWO_SIDED|97.5|-4.9|2.8|||||Change in PHQ-8 score from baseline to week 52 in the financial rewards arm minus the change in PHQ-8 score from baseline to week 52 in the no rewards arm.|||2.8|-4.9|
70970738|NCT02484911|141447177|SUPERIORITY_OR_OTHER|||||||0.246|||||||Chi-squared|||||||0.246
70915710|NCT02957539|141322269|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|97.5|-2.9|3.6|||||The change in PHQ-8 from baseline to week 52 in the nonfinancial incentive arm minus the change in PHQ-8 from baseline to week 52 in the no rewards arm|||3.6|-2.9|
70915711|NCT02957539|141322270|SUPERIORITY||Mean Difference (Net)|-3.2|||||TWO_SIDED|97.5|-7.4|1.0|||||Change in weight from baseline to week 16 in the financial rewards arm minus the change in weight from baseline to week 16 in the no rewards arm.|||1|-7.4|
70915712|NCT02957539|141322270|SUPERIORITY||Mean Difference (Net)|-4.6|||||TWO_SIDED|97.5|-8.7|-0.4|||||Change in weight from baseline to week 16 in the nonfinancial rewards arm minus the change in weight from baseline to week 32 in the no rewards arm.|||-0.4|-8.7|
70915713|NCT02957539|141322271|SUPERIORITY||Mean Difference (Net)|2.4|||||TWO_SIDED|97.5|-6.0|10.7|||||Change in weight from baseline to week 52 in the financial rewards arm minus the change in weight from baseline to week 52 in the no rewards arm.|||10.7|-6|
70915714|NCT02957539|141322271|SUPERIORITY||Mean Difference (Net)|-3.6|||||TWO_SIDED|97.5|-11.2|4.1|||||Change in weight from baseline to week 52 in the nonfinancial rewards arm minus the change in weight from baseline to week 52 in the no rewards arm.|||4.1|-11.2|
70915715|NCT00855465|141322344|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Prespecified significance level for all significance tests was 5%. Primary analysis, due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|Test was stratified by region.||Missing values for participants who withdrew/died before 16 weeks were imputed with a worst value of 0m in case of death/clinical worsening without termination visit and with the last observed value otherwise. Comparison was done using analysis of covariance (ANCOVA), with baseline 6MWD as a covariate and treatment group and region as main effects. The primary statistical method was the stratified Wilcoxon test if the Shapiro-Wilk test for normality of residuals was statistically significant.||||<0.0001
70915716|NCT00855465|141322344|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|45.69|||<|0.0001|TWO_SIDED|95.0|24.74|66.63||Additional analysis, due to result of Shapiro-Wilk test.|ANCOVA|||||66.63|24.74|<0.0001
70915717|NCT00855465|141322344|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
70915718|NCT00855465|141322345|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|||Missing values at week 16 were imputed using the last available post-baseline observation. Same analysis method as for primary efficacy parameter.||||<0.0001
71092971|NCT04153864|141692736|NON_INFERIORITY|The NIM was defined as 13% of the mean EPDS score in the In-Person group (8.81), which corresponded to a value of 1.15. This predetermined NIM of 13% aligns with noninferiority guidelines and ensures clinically meaningful conclusions.|Mean Difference (Final Values)|0.36|||<|0.05|ONE_SIDED|95.0||0.91|||t-test, 1 sided|||Behavioral Activation (BA) delivered via Telemedicine will be non-inferior to BA delivered In-Person if the upper limit of the 95% confidence interval for the estimated mean difference in EPDS scores is less than the pre-specified 13% non-inferiority margin (NIM). Please note, this is per protocol analysis. Due to institutional pandemic-related restrictions, 21 participants were switched from In-Person to Telemedicine and met criteria for the per protocol analyses.||0.91||<0.05
70915719|NCT00855465|141322345|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-246.43|||<|0.0001|TWO_SIDED|95.0|-303.33|-189.53||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-189.53|-303.33|<0.0001
70915720|NCT00855465|141322345|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
70915721|NCT00855465|141322346|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|||Missing values at week 16 were imputed using the last available post-baseline observation. Same analysis method as for primary efficacy parameter.||||<0.0001
70915722|NCT00855465|141322346|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-443.99||||0.0293|TWO_SIDED|95.0|-842.95|-45.03||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-45.03|-842.95|0.0293
70915723|NCT00855465|141322346|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
70915724|NCT00855465|141322347|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0026||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.|Wilcoxon (Mann-Whitney)|Test was stratified by region.||Missing values for participants who withdrew or died before 16 weeks were imputed with a worst value of IV in case of clinical worsening without termination visit or measurement at that termination visit and with a worst value of V in case of death and with the last observed value otherwise.||||0.0026
70915725|NCT00855465|141322348|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-3.37||||0.1724|TWO_SIDED|95.0|-8.72|1.99||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.|Log Rank|Test was stratified by region.|Based on Mantel-Haenszel estimate stratified by region.|"Test for difference of occurence of Any event."||1.99|-8.72|0.1724
70915726|NCT00855465|141322349|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0035||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH. Nominally significant only due to hierarchical testing.|Wilcoxon (Mann-Whitney)|Test was stratified by region.||Missing values for participants who withdrew or died before 16 weeks were imputed with a worst value of 10 in case of death or clinical worsening without termination visit and with the last observed value otherwise.||||0.0035
70970739|NCT04129528|141447179|SUPERIORITY||Ratio of geometric means CFZ533/placebo|1.173||||0.1817|TWO_SIDED|80.0|0.94|1.47||one-sided P-value|Mixed model repeated measure analysis|||||1.47|0.94|0.1817
70970740|NCT01964352|141447196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.331|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.293|0.369|||Mixed Effects Model for Repeated Measure|||||0.369|0.293|<0.0001
71153911|NCT00488683|141800065|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.04||||0.63||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup C||||0.63
70915727|NCT00855465|141322350|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO FC, TTCW, Borg scale, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.Nominally significant only due to hierarchical testing.|Wilcoxon (Mann-Whitney)|||Missing values at baseline were imputed using last available observation prior to start of study treatment. Missing values for participants who withdrew or died before 16 weeks were imputed with a worst value of -0.594 in case of death or clinical worsening without termination visit and with the last observed value otherwise.||||<0.0001
70915728|NCT00855465|141322350|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13||||0.0002|TWO_SIDED|95.0|0.06|0.21||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||0.21|0.06|0.0002
70915729|NCT00855465|141322350|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
70915730|NCT00855465|141322351|SUPERIORITY_OR_OTHER_LEGACY|||||||0.122||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg Dyspnea Score, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|||Missing values at baseline were imputed using last available observation prior to start of study treatment. Missing values for participants who withdrew or died before 16 weeks were imputed with a worst value of 105 in case of death or clinical worsening without termination visit and with the last observed value otherwise.||||0.1220
70915731|NCT00855465|141322351|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.76||||0.0165|TWO_SIDED|95.0|-10.45|-1.06||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-1.06|-10.45|0.0165
70915732|NCT00855465|141322351|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
70915733|NCT00855465|141322353|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Exploratory testing. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|||Missing values at week 16 were imputed using the last available post-baseline observation. Same analysis as for primary efficacy parameter.||||<0.0001
70915734|NCT00855465|141322353|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.96|||<|0.0001|TWO_SIDED|95.0|-6.75|-3.16||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-3.16|-6.75|<0.0001
70915735|NCT00855465|141322353|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0231|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0231
70915736|NCT00855465|141322354|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.47|||<|0.0001|TWO_SIDED|95.0|0.33|0.62||Exploratory testing. Primary analysis due to result of Shapiro-Wilk test.|ANCOVA|||Missing values at week 16 were imputed using the last available post-baseline observation. Same analysis as for primary efficacy parameter.||0.62|0.33|<0.0001
70915737|NCT00855465|141322354|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Additional analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|||||||<0.0001
70915738|NCT00855465|141322354|SUPERIORITY_OR_OTHER_LEGACY|||||||0.116|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.1160
70915739|NCT01157182|141322390|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.94|||||TWO_SIDED|90.0|97.63|108.55|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.55|97.63|
70915740|NCT01157182|141322391|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.4|||||TWO_SIDED|90.0|95.15|101.76|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.76|95.15|
70915741|NCT01157182|141322392|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.73|||||TWO_SIDED|90.0|95.33|102.26|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||102.26|95.33|
70915742|NCT01157182|141322393|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|92.51|||||TWO_SIDED|90.0|88.64|96.55|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||96.55|88.64|
70915743|NCT01157182|141322394|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.66|||||TWO_SIDED|90.0|92.6|98.81|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||98.81|92.60|
70970741|NCT01964352|141447196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.075|0.148|||Mixed Effects Model for Repeated Measure|||||0.148|0.075|<0.0001
70970742|NCT01964352|141447196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.262|0.337|||Mixed Effects Model for Repeated Measure|||||0.337|0.262|<0.0001
71092972|NCT04153864|141692738|NON_INFERIORITY|The NIM was defined as 10% of the mean GAD-7 score for the Specialist group (6.36), which corresponded to a value of 0.64. This predetermined NIM of 10% aligns with noninferiority guidelines and ensures clinically meaningful conclusions.|Mean Difference (Final Values)|0.08|||<|0.05|ONE_SIDED|95.0||0.57|||t-test, 1 sided|||Behavioral Activation (BA) delivered by Non-Specialists will be non-inferior to BA delivered by Specialists if the upper limit of the 95% confidence interval for the estimated mean difference in GAD-7 scores is less than the pre-specified 10% non-inferiority margin (NIM).This analysis was performed on 3-months post-randomization scores.||0.57||<0.05
70915744|NCT01157182|141322395|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.71|||||TWO_SIDED|90.0|92.62|98.91|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||98.91|92.62|
70915745|NCT01157182|141322396|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|92.41|||||TWO_SIDED|90.0|88.65|96.33|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||96.33|88.65|
70915746|NCT01157182|141322397|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.67|||||TWO_SIDED|90.0|92.68|98.77|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||98.77|92.68|
70915747|NCT01157182|141322398|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.73|||||TWO_SIDED|90.0|92.68|98.88|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||98.88|92.68|
70915748|NCT01157182|141322399|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|91.21|||||TWO_SIDED|90.0|84.62|98.31|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||98.31|84.62|
70915749|NCT01157182|141322400|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|94.11|||||TWO_SIDED|90.0|89.04|99.47|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||99.47|89.04|
70915750|NCT01157182|141322401|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.48|||||TWO_SIDED|90.0|90.7|104.76|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||104.76|90.70|
71092973|NCT04153864|141692738|NON_INFERIORITY|The NIM was defined as 13% of the mean GAD-7 score in the In-Person group (6.29), which corresponded to a value of 0.82. This predetermined NIM of 13% aligns with noninferiority guidelines and ensures clinically meaningful conclusions.|Mean Difference (Final Values)|0.14|||<|0.05|ONE_SIDED|95.0||0.73|||t-test, 1 sided|||Behavioral Activation (BA) delivered via Telemedicine will be non-inferior to BA delivered In-Person if the upper limit of the 95% confidence interval for the estimated mean difference in GAD-7 scores is less than the pre-specified 13% non-inferiority margin (NIM). Please note, this presents the Intention to Treat (ITT) analysis.||0.73||<0.05
70915751|NCT01157182|141322402|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|94.19|||||TWO_SIDED|90.0|89.78|98.81|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||98.81|89.78|
71092974|NCT00724945|141692740|SUPERIORITY_OR_OTHER||Least Square Mean|-0.08591|STANDARD_ERROR_OF_MEAN|0.008816||||95.0|-0.08591|-0.06857|||Mixed Models Analysis|||Alternative hypothesis: senofilcon A multifocal would be better than or equal to 0.1 logMAR units.||-0.06857|-0.08591|
70915752|NCT01157182|141322403|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.99|||||TWO_SIDED|90.0|92.73|99.36|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||99.36|92.73|
70915753|NCT01157182|141322404|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.22|||||TWO_SIDED|90.0|93.62|100.96|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||100.96|93.62|
70915754|NCT01157182|141322405|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|91.73|||||TWO_SIDED|90.0|84.46|99.62|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||99.62|84.46|
70915755|NCT01157182|141322406|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.47|||||TWO_SIDED|90.0|88.37|103.14|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||103.14|88.37|
70915756|NCT01157182|141322407|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.63|||||TWO_SIDED|90.0|88.1|103.81|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||103.81|88.10|
70915757|NCT01157182|141322408|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|94.15|||||TWO_SIDED|90.0|89.56|98.98|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||98.98|89.56|
70915758|NCT01157182|141322409|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.01|||||TWO_SIDED|90.0|92.14|100.04|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||100.04|92.14|
70915759|NCT01157182|141322410|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.75|||||TWO_SIDED|90.0|92.75|100.93|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||100.93|92.75|
70915760|NCT00716144|141322411|SUPERIORITY_OR_OTHER|||||||0.884|||||||Cochran-Armitage Trend Test|||||||0.884
70915761|NCT00716144|141322412|SUPERIORITY_OR_OTHER|||||||1|||||||Cochran-Armitage Trend Test|||At Visit 3||||1.000
71092975|NCT00724945|141692741|SUPERIORITY_OR_OTHER||Least Square Mean|0.02711|STANDARD_ERROR_OF_MEAN|0.008816||||97.5|0.02711|0.04445|||Mixed Models Analysis|||Alternative hypothesis: senofilcon A multifocal lens would be better than or equal to 0.17 logMAR units.||0.04445|0.02711|
71092976|NCT00724945|141692742|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is -0.5.|Mean Difference (Final Values)|0.07407|STANDARD_ERROR_OF_MEAN|0.1279||||97.5|-0.1797|0.07407|||Mixed Models Analysis||Mean difference was calculated as senofilcon A multifocal minus balafilcon A multifocal.|Alternative hypothesis: senofilcon A multifocal lens will have subjective vision that is non-inferior to balafilcon A multifocal.||0.07407|-0.1797|
70915762|NCT00716144|141322412|SUPERIORITY_OR_OTHER|||||||0.604|||||||Cochran-Armitage Trend Test|||At Visit 4||||0.604
70915763|NCT00716144|141322412|SUPERIORITY_OR_OTHER|||||||0.463|||||||Cochran-Armitage Trend Test|||At Visit 5||||0.463
70915764|NCT00716144|141322412|SUPERIORITY_OR_OTHER|||||||0.042|||||||Cochran-Armitage Trend Test|||At Visit 6||||0.042
70915765|NCT00716144|141322412|SUPERIORITY_OR_OTHER|||||||0.034|||||||Cochran-Armitage Trend Test|||At Visit 7||||0.034
70915766|NCT00716144|141322412|SUPERIORITY_OR_OTHER|||||||0.019|||||||Cochran-Armitage Trend Test|||At Visit 8||||0.019
70915767|NCT00716144|141322414|SUPERIORITY_OR_OTHER|||||||1|||||||Cochran-Armitage Trend Test|||At Visit 3||||1.000
70915768|NCT00716144|141322414|SUPERIORITY_OR_OTHER|||||||0.673|||||||Cochran-Armitage Trend Test|||At Visit 4||||0.673
70915769|NCT00716144|141322414|SUPERIORITY_OR_OTHER|||||||0.55|||||||Cochran-Armitage Trend Test|||At Visit 5||||0.550
70915770|NCT00716144|141322414|SUPERIORITY_OR_OTHER|||||||0.721|||||||Cochran-Armitage Trend Test|||At Visit 7||||0.721
70915771|NCT00716144|141322414|SUPERIORITY_OR_OTHER|||||||0.03|||||||Cochran-Armitage Trend Test|||At Visit 8||||0.030
70915772|NCT00367055|141322426|SUPERIORITY_OR_OTHER|||||||0.376||95.0||||p value is for Total AUC(0-10 min)|Van Elteren|||||||0.376
71092977|NCT05352763|141692802|OTHER|No statistical analysis performed|||||||||||||||||The classical summary of count and percentages will be provided for basic safety tabulations and dispositions as appropriate. All data will be presented in by-subject data listings. No inferential statistics will be produced.|||
71092978|NCT01970371|141692865|SUPERIORITY|The 2-sided 90% confidence interval (CI) for the difference between groups in Cohort 1 (colistin minus plazomicin) is based on the unconditional exact method.|Difference Estimate|26.5|||||TWO_SIDED|90.0|-0.7|51.2|||1-sided Fisher's exact test|||||51.2|-0.7|
70915773|NCT00367055|141322426|SUPERIORITY_OR_OTHER|||||||0.99||95.0||||p value is for Incremental AUC(0-10 min)|Van Elteren|||||||0.990
70915774|NCT02459899|141322436|SUPERIORITY||Least squares mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.139||0.07|TWO_SIDED|95.0|-0.53|0.02||Threshold for significance \< 0.05|MMRM|||Analysis was performed using MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline A1C-by-time interaction as a covariate.||0.02|-0.53|0.07
70915775|NCT02459899|141322436|SUPERIORITY||Least squares mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.135|<|0.001|TWO_SIDED|95.0|-0.75|-0.22||Threshold for significance \< 0.05|MMRM|||Analysis was performed using MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline A1C-by-time interaction as a covariate.||-0.22|-0.75|<0.001
70915776|NCT02459899|141322436|SUPERIORITY||Least squares mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.136||0.006|TWO_SIDED|95.0|-0.65|-0.11||Threshold for significance \< 0.05|MMRM|||Analysis was performed using MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline A1C-by-time interaction as a covariate.||-0.11|-0.65|0.006
70915777|NCT04470193|141322445|SUPERIORITY|We approached 62 subjects to get a sample size of 50 participants, allowing up to 16% attrition, to estimate the proportions of patients satisfying dropout of 0.13 to within margins of error (half-widths of 90% Cis). The 50 evaluable subjects were used to estimate the SD of QoL, with a margin of error of ∼20%. The sample size also allowed us to provide provisional estimates of the effect size for the QoL outcome to within a margin of error of ±7.1 points, assuming a true SD of 15 points.|||||>|0.05|||||||generalized estimating equation model|||We used a generalized estimating equation model for repeated assessments, with a common unstructured residual covariance matrix to account for correlation in repeated measurements in the same patient, to compare QoL total score at baseline, 1 month, and 3 months between the groups. We hypothesized that MyChildCMC users would have better outcomes for the child (higher QoL, fewer ED and/or hospital use and hospital days) and parent (higher satisfaction with child's care).||||>0.05
70915778|NCT04470193|141322446|SUPERIORITY||Risk Ratio (RR)|1.05||||0.882|TWO_SIDED|95.0|0.58|1.88|||Mixed Models Analysis|||||1.88|0.58|0.882
70915779|NCT04470193|141322447|SUPERIORITY||Risk Ratio (RR)|0.49|||<|0.001|TWO_SIDED|95.0|0.39|0.62|||Mixed Models Analysis|||||0.62|0.39|<0.001
70915780|NCT04470193|141322448|SUPERIORITY||Risk Ratio (RR)|1.11||||0.035|TWO_SIDED|95.0|1.01|1.22|||Mixed Models Analysis|||||1.22|1.01|0.035
70915781|NCT03612804|141322462|SUPERIORITY||Odds Ratio (OR)|1.05||||0.83|TWO_SIDED|95.0|0.67|1.64||P-value not adjusted for multiple comparisons. A priori threshold for statistical significance was 0.05.|Regression, Logistic|Logistic regression model with random intercept for provider and main effect term for study site.|Proactive care arm represents numerator of odds ratio, unstructured care arm represents denominator of odds ratio.|||1.64|0.67|0.83
70915782|NCT03105128|141322470|SUPERIORITY||Adjusted Risk Difference|20.7|||<|0.001|TWO_SIDED|95.0|12.4|29.0|||Cochran-Mantel-Haenszel|||||29.0|12.4|<0.001
70915783|NCT03105128|141322470|SUPERIORITY||Adjusted Risk Difference|16.7|||<|0.001|TWO_SIDED|95.0|8.5|24.9|||Cochran-Mantel-Haenszel|||||24.9|8.5|<0.001
71092979|NCT01970371|141692866|SUPERIORITY|The 2-sided 90% confidence interval (CI) for the difference between groups in Cohort 1 (colistin minus plazomicin) is based on the unconditional exact method.|Difference Estimate|28.2|||||TWO_SIDED|90.0|0.7|52.5|||1-sided Fisher's exact test|||||52.5|0.7|
70915784|NCT03105128|141322471|SUPERIORITY||Adjusted Risk Difference|28.3|||<|0.001|TWO_SIDED|95.0|21.2|35.4|||Cochran-Mantel-Haenszel|||||35.4|21.2|<0.001
70915785|NCT03105128|141322471|SUPERIORITY||Adjusted Risk Difference|20.3|||<|0.001|TWO_SIDED|95.0|13.6|27.1|||Cochran-Mantel-Haenszel|||||27.1|13.6|<0.001
71092980|NCT01970371|141692867|SUPERIORITY|The 2-sided 90% confidence interval (CI) for the difference in clinical cure percentage at the TOC visit between groups in Cohort 1 (colistin minus plazomicin) is based on the unconditional exact method.|Difference Estimate|-0.3|||||TWO_SIDED|90.0|-26.9|26.8|||1-sided Fisher's exact test|||||26.8|-26.9|
70915786|NCT03105128|141322472|SUPERIORITY||Adjusted Risk Difference|21.9|||<|0.001|TWO_SIDED|95.0|13.8|29.9|||Cochran-Mantel-Haenszel|||||29.9|13.8|<0.001
71092981|NCT01970371|141692868|SUPERIORITY|The 2-sided 90% confidence interval (CI) for the unadjusted hazard ratio between groups in Cohort 1 (colistin:plazomicin) is based on a Cox proportional hazards regression model.|Hazard Ratio (HR)|3.97|||||TWO_SIDED|90.0|1.08|14.61|||1-sided logrank test|||||14.61|1.08|
70915787|NCT03105128|141322472|SUPERIORITY||Adjusted Risk Difference|18.8|||<|0.001|TWO_SIDED|95.0|10.8|26.8|||Cochran-Mantel-Haenszel|||||26.8|10.8|<0.001
70915788|NCT03105128|141322473|SUPERIORITY||Adjusted Risk Difference|28.3|||<|0.001|TWO_SIDED|95.0|21.2|35.4|||Cochran-Mantel-Haenszel|||||35.4|21.2|<0.001
70915789|NCT03105128|141322473|SUPERIORITY||Adjusted Risk Difference|20.3|||<|0.001|TWO_SIDED|95.0|13.6|27.1|||Cochran-Mantel-Haenszel|||||27.1|13.6|<0.001
70915790|NCT03105128|141322474|SUPERIORITY||Risk Difference (RD)|21.9|||<|0.001|TWO_SIDED|95.0|13.8|29.9|||Cochran-Mantel-Haenszel|||||29.9|13.8|<0.001
70915791|NCT03105128|141322474|SUPERIORITY||Adjusted Risk Difference|18.8|||<|0.001|TWO_SIDED|95.0|10.8|26.8|||Cochran-Mantel-Haenszel|||||26.8|10.8|<0.001
70915792|NCT03105128|141322475|SUPERIORITY||Adjusted Risk Difference|15.4|||<|0.001|TWO_SIDED|95.0|7.2|23.7|||Cochran-Mantel-Haenszel|||||23.7|7.2|<0.001
70915793|NCT03105128|141322475|SUPERIORITY||Adjusted Risk Difference|11.2||||0.007|TWO_SIDED|95.0|3.1|19.2|||Cochran-Mantel-Haenszel|||||19.2|3.1|0.007
70915794|NCT03105128|141322476|SUPERIORITY||Adjusted Risk Difference|23.1|||<|0.001|TWO_SIDED|95.0|14.2|31.9|||Cochran-Mantel-Haenszel|||||31.9|14.2|<0.001
71092982|NCT01970371|141692869|SUPERIORITY|The two-sided 90% confidence interval for the difference between groups in Cohort 1 (colistin minus plazomicin) is based on the unconditional exact method.|Difference Estimate|14.1|||||TWO_SIDED|90.0|-13.0|40.3|||1-sided Fisher's exact test|||||40.3|-13|
70915795|NCT03105128|141322476|SUPERIORITY||Adjusted Risk Difference|27.7|||<|0.001|TWO_SIDED|95.0|19.0|36.4|||Cochran-Mantel-Haenszel|||||36.4|19.0|<0.001
70915796|NCT03105128|141322477|SUPERIORITY||Adjusted Risk Difference|5.2|||<|0.001|TWO_SIDED|95.0|3.2|7.2|||Cochran-Mantel-Haenszel|||||7.2|3.2|<0.001
70915797|NCT03105128|141322477|SUPERIORITY||Adjusted Risk Difference|4.1|||<|0.001|TWO_SIDED|95.0|2.1|6.1|||Cochran-Mantel-Haenszel|||||6.1|2.1|<0.001
70915798|NCT03105128|141322478|SUPERIORITY||Adjusted Risk Difference|7.6||||0.015|TWO_SIDED|95.0|1.5|13.7|||Cochran-Mantel-Haenszel|||||13.7|1.5|0.015
70915799|NCT03105128|141322478|SUPERIORITY||Adjusted Risk Difference|8.4||||0.007|TWO_SIDED|95.0|2.3|14.6|||Cochran-Mantel-Haenszel|||||14.6|2.3|0.007
70915800|NCT03105128|141322479|SUPERIORITY||Adjusted Risk Difference|24.5|||<|0.001|TWO_SIDED|95.0|18.5|30.5|||Cochran-Mantel-Haenszel|||||30.5|18.5|<0.001
70915801|NCT03105128|141322479|SUPERIORITY||Adjusted Risk Difference|17.3|||<|0.001|TWO_SIDED|95.0|11.8|22.9|||Cochran-Mantel-Haenszel|||||22.9|11.8|<0.001
70915802|NCT03105128|141322480|SUPERIORITY||Adjusted Risk Difference|24.2|||<|0.001|TWO_SIDED|95.0|15.7|32.7|||Cochran-Mantel-Haenszel|||||32.7|15.7|<0.001
70915803|NCT03105128|141322480|SUPERIORITY||Adjusted Risk Difference|23.6|||<|0.001|TWO_SIDED|95.0|15.1|32.1|||Cochran-Mantel-Haenszel|||||32.1|15.1|<0.001
70915804|NCT03105128|141322481|SUPERIORITY||Adjusted Risk Difference|21.2|||<|0.001|TWO_SIDED|95.0|12.4|30.0|||Cochran-Mantel-Haenszel|||||30.0|12.4|<0.001
70915805|NCT03105128|141322481|SUPERIORITY||Adjusted Risk Difference|19.0|||<|0.001|TWO_SIDED|95.0|10.1|27.8|||Cochran-Mantel-Haenszel|||||27.8|10.1|<0.001
70915806|NCT03105128|141322482|SUPERIORITY||Adjusted Risk Difference|15.1|||<|0.001|TWO_SIDED|95.0|9.0|21.2|||Cochran-Mantel-Haenszel|||||21.2|9.0|<0.001
71092983|NCT01348269|141692875|OTHER|T-test (with MITT, omitting outlier value of one patient in placebo group)|||||=|0.006|||||||t-test, 2 sided|||||||=0.006
70915807|NCT03105128|141322482|SUPERIORITY||Adjusted Risk Difference|15.4|||<|0.001|TWO_SIDED|95.0|9.4|21.4|||Cochran-Mantel-Haenszel|||||21.4|9.4|<0.001
70915808|NCT03105128|141322483|SUPERIORITY||Adjusted Risk Difference|14.9||||0.001|TWO_SIDED|95.0|6.2|23.5|||Cochran-Mantel-Haenszel|||||23.5|6.2|0.001
70915809|NCT03105128|141322483|SUPERIORITY||Adjusted Risk Difference|11.8||||0.007|TWO_SIDED|95.0|3.2|20.3|||Cochran-Mantel-Haenszel|||||20.3|3.2|0.007
70915810|NCT03105128|141322484|SUPERIORITY||Adjusted Risk Difference|13.7|||<|0.001|TWO_SIDED|95.0|7.9|19.5|||Cochran-Mantel-Haenszel|||||19.5|7.9|<0.001
70915811|NCT03105128|141322484|SUPERIORITY||Adjusted Risk Difference|9.1||||0.001|TWO_SIDED|95.0|3.7|14.5|||Cochran-Mantel-Haenszel|||||14.5|3.7|0.001
70915812|NCT03105128|141322485|SUPERIORITY||Adjusted Risk Difference|21.0|||<|0.001|TWO_SIDED|95.0|12.2|29.9|||Cochran-Mantel-Haenszel|||||29.9|12.2|<0.001
70915813|NCT03105128|141322485|SUPERIORITY||Adjusted Risk Difference|21.6|||<|0.001|TWO_SIDED|95.0|12.8|30.4|||Cochran-Mantel-Haenszel|||||30.4|12.8|<0.001
71092984|NCT01348269|141692875|OTHER|Mann-Whitney-Test|||||=|0.015|||||||Wilcoxon (Mann-Whitney)|||||||=0.015
70915814|NCT03105128|141322486|SUPERIORITY||Adjusted Risk Difference|14.6||||0.022|TWO_SIDED|95.0|2.1|27.0|||Cochran-Mantel-Haenszel|||||27.0|2.1|0.022
70915815|NCT03105128|141322486|SUPERIORITY||Adjusted Risk Difference|23.7|||<|0.001|TWO_SIDED|95.0|11.1|36.3|||Cochran-Mantel-Haenszel|||||36.3|11.1|<0.001
70915816|NCT03105128|141322487|SUPERIORITY||Risk Difference (RD)|-8.7|||<|0.001|TWO_SIDED|95.0|-13.9|-3.5|||Chi-squared|||||-3.5|-13.9|<0.001
70915817|NCT03105128|141322487|SUPERIORITY||Risk Difference (RD)|-10.2|||<|0.001|TWO_SIDED|95.0|-15.2|-5.2|||Chi-squared|||||-5.2|-15.2|<0.001
70915818|NCT03105128|141322488|SUPERIORITY||Risk Difference (RD)|5.6||||1|TWO_SIDED|95.0|-28.6|39.7|||Chi-squared|||||39.7|-28.6|1.00
70915819|NCT03105128|141322488|SUPERIORITY||Risk Difference (RD)|6.9||||1|TWO_SIDED|25.0|-25.7|39.6|||Chi-squared|||||39.6|-25.7|1.000
70915820|NCT03105128|141322489|SUPERIORITY||Adjusted Risk Difference|20.7|||<|0.001|TWO_SIDED|95.0|12.4|29.0|||Cochran-Mantel-Haenszel|||||29.0|12.4|<0.001
70915821|NCT03105128|141322489|SUPERIORITY||Adjusted Risk Difference|16.7|||<|0.001|TWO_SIDED|95.0|8.5|24.9|||Cochran-Mantel-Haenszel|||||24.9|8.5|<0.001
70915822|NCT03105128|141322490|SUPERIORITY||Adjusted Risk Difference|15.4|||<|0.001|TWO_SIDED|95.0|7.2|23.7|||Cochran-Mantel-Haenszel|||||23.7|7.2|<0.001
70915823|NCT03105128|141322490|SUPERIORITY||Adjusted Risk Difference|11.2||||0.007|TWO_SIDED|95.0|3.1|19.2|||Cochran-Mantel-Haenszel|||||19.2|3.1|0.007
70915824|NCT03105128|141322491|SUPERIORITY||Adjusted Risk Difference|11.5|||<|0.001|TWO_SIDED|95.0|5.4|17.5|||Cochran-Mantel-Haenszel|||||17.5|5.4|<0.001
70915825|NCT03105128|141322491|SUPERIORITY||Adjusted Risk Difference|11.7|||<|0.001|TWO_SIDED|95.0|5.7|17.8|||Cochran-Mantel-Haenszel|||||17.8|5.7|<0.001
70915826|NCT03105128|141322492|SUPERIORITY||Adjusted Risk Difference|23.1|||<|0.001|TWO_SIDED|95.0|14.2|31.9|||Cochran-Mantel-Haenszel|||||31.9|14.2|<0.001
70915827|NCT03105128|141322492|SUPERIORITY||Adjusted Risk Difference|27.7|||<|0.001|TWO_SIDED|95.0|19.0|36.4|||Cochran-Mantel-Haenszel|||||36.4|19.0|<0.001
70915828|NCT03105128|141322493|SUPERIORITY||LS Mean Difference|5.2|||<|0.001|TWO_SIDED|95.0|3.2|7.2|||Mixed-Effect Model Repeat Measurement|||||7.2|3.2|<0.001
70915829|NCT03105128|141322493|SUPERIORITY||LS Mean Difference|4.1|||<|0.001|TWO_SIDED|95.0|2.1|6.1|||Mixed-Effect Model Repeat Measurement|||||6.1|2.1|<0.001
70915830|NCT03105128|141322494|SUPERIORITY||LS Mean Difference|20.7|||<|0.001|TWO_SIDED|95.0|14.3|27.1|||Mixed-Effect Model Repeat Measurement|||||27.1|14.3|<0.001
70915831|NCT03105128|141322494|SUPERIORITY||LS Mean Difference|19.4|||<|0.001|TWO_SIDED|95.0|13.1|25.8|||Mixed-Effect Model Repeat Measurement|||||25.8|13.1|<0.001
70915832|NCT03105128|141322495|SUPERIORITY||Adjusted Risk Difference|23.2|||<|0.001|TWO_SIDED|95.0|16.8|29.6|||Cochran-Mantel-Haenszel|||||29.6|16.8|<0.001
71092985|NCT02313155|141692971|SUPERIORITY_OR_OTHER||Difference|-6.6|||||TWO_SIDED|95.0|-24.858|11.592|||||Seroconversion rate difference between treatment groups was obtained by subtracting the value of TAK-850 I.M. from TAK-850 S.C.|A/H1N1 Strain||11.592|-24.858|
71092986|NCT02313155|141692971|SUPERIORITY_OR_OTHER||Difference|-15.5|||||TWO_SIDED|95.0|-33.779|2.87|||||Seroconversion rate difference between treatment groups was obtained by subtracting the value of TAK-850 I.M. from TAK-850 S.C.|A/H3N2 Strain||2.870|-33.779|
71092987|NCT02313155|141692971|SUPERIORITY_OR_OTHER||Difference|-11.8|||||TWO_SIDED|95.0|-30.048|6.547|||||Seroconversion rate difference between treatment groups was obtained by subtracting the value of TAK-850 I.M. from TAK-850 S.C.|B Strain||6.547|-30.048|
71092988|NCT00689936|141692990|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72||||6e-05|TWO_SIDED|95.0|0.61|0.85||The p-value is based on the unstratified log-rank test.|Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|||0.85|0.61|0.00006
70915833|NCT03105128|141322495|SUPERIORITY||Adjusted Risk Difference|15.2|||<|0.001|TWO_SIDED|95.0|9.3|21.2|||Cochran-Mantel-Haenszel|||||21.2|9.3|<0.001
70915834|NCT03105128|141322496|SUPERIORITY||Adjusted Risk Difference|15.1|||<|0.001|TWO_SIDED|95.0|9.0|21.2|||Cochran-Mantel-Haenszel|||||21.2|9.0|<0.001
70915835|NCT03105128|141322496|SUPERIORITY||Adjusted Risk Difference|15.4|||<|0.001|TWO_SIDED|95.0|9.4|21.4|||Cochran-Mantel-Haenszel|||||21.4|9.4|<0.001
70915836|NCT03105128|141322497|SUPERIORITY||Adjusted Risk Difference|14.9||||0.001|TWO_SIDED|95.0|6.2|23.5|||Cochran-Mantel-Haenszel|||||23.5|6.2|0.001
70915837|NCT03105128|141322497|SUPERIORITY||Adjusted Risk Difference|11.8||||0.007|TWO_SIDED|95.0|3.2|20.3|||Cochran-Mantel-Haenszel|||||20.3|3.2|0.007
70915838|NCT03105128|141322498|SUPERIORITY||Adjusted Risk Difference|13.7|||<|0.001|TWO_SIDED|95.0|7.9|19.5|||Cochran-Mantel-Haenszel|||||19.5|7.9|<0.001
70915839|NCT03105128|141322498|SUPERIORITY||Adjusted Risk Difference|9.1||||0.001|TWO_SIDED|95.0|3.7|14.5|||Cochran-Mantel-Haenszel|||||14.5|3.7|0.001
70915840|NCT03105128|141322499|SUPERIORITY||Adjusted Risk Difference|21.0|||<|0.001|TWO_SIDED|95.0|12.2|29.9|||Cochran-Mantel-Haenszel|||||29.9|12.2|<0.001
70915841|NCT03105128|141322499|SUPERIORITY||Adjusted Risk Difference|21.6|||<|0.001|TWO_SIDED|95.0|12.8|30.4|||Cochran-Mantel-Haenszel|||||30.4|12.8|<0.001
70915842|NCT03105128|141322500|SUPERIORITY||Adjusted Risk Difference|14.6||||0.022|TWO_SIDED|95.0|2.1|27.0|||Cochran-Mantel-Haenszel|||||27.0|2.1|0.022
70915843|NCT03105128|141322500|SUPERIORITY||Adjusted Risk Difference|23.7|||<|0.001|TWO_SIDED|95.0|11.1|36.3|||Cochran-Mantel-Haenszel|||||36.3|11.1|<0.001
70915844|NCT03105128|141322501|SUPERIORITY||LS Mean Difference|-8.7|||<|0.001|TWO_SIDED|95.0|-13.9|-3.5|||Mixed-Effect Model Repeat Measurement|||||-3.5|-13.9|<0.001
70915845|NCT03105128|141322501|SUPERIORITY||LS Mean Difference|-10.2|||<|0.001|TWO_SIDED|95.0|-15.2|-5.2|||Mixed-Effect Model Repeat Measurement|||||-5.2|-15.2|<0.001
70915846|NCT03105128|141322502|SUPERIORITY||LS Mean Difference|5.6||||1|TWO_SIDED|95.0|-28.6|39.7|||Mixed-Effect Model Repeat Measurement|||||39.7|-28.6|1.000
70915847|NCT03105128|141322502|SUPERIORITY||LS Mean Difference|6.9||||1|TWO_SIDED|95.0|-25.7|39.6|||Mixed-Effect Model Repeat Measurement|||||39.6|-25.7|1.000
70915848|NCT03105128|141322503|SUPERIORITY||LS Mean Difference|-9.586||||0.024|TWO_SIDED|95.0|-17.89|-1.282|||Mixed-Effect Model Repeat Measurement|||||-1.282|-17.890|0.024
70915849|NCT03105128|141322503|SUPERIORITY||LS Mean Difference|-12.141||||0.004|TWO_SIDED|95.0|-20.39|-3.892|||Mixed-Effect Model Repeat Measurement|||||-3.892|-20.390|0.004
70915850|NCT03105128|141322504|SUPERIORITY||LS Mean Difference|2.913|||<|0.001|TWO_SIDED|95.0|1.512|4.313|||Mixed-Effect Model Repeat Measurement|||||4.313|1.512|<0.001
70915851|NCT03105128|141322504|SUPERIORITY||LS Mean Difference|3.275|||<|0.001|TWO_SIDED|95.0|1.877|4.672|||Mixed-Effect Model Repeat Measurement|||||4.672|1.877|<0.001
70915852|NCT00038103|141322522|SUPERIORITY_OR_OTHER||Clinical Benefit Rate|49.0||||||95.0|34.4|63.7|||||Number of subjects showing clinical benefits out of the number of subjects in the evaluable set.|||63.7|34.4|
70915853|NCT00038103|141322522|SUPERIORITY_OR_OTHER||Clinical Benefit Rate|47.1||||||95.0|32.9|61.5|||||Number of subjects showing clinical benefits out of the number of subjects in the evaluable set.|||61.5|32.9|
71092989|NCT00689936|141692990|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7||||1e-05|TWO_SIDED|95.0|0.6|0.82||The p-value is based on the unstratified log-rank test.|Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|||0.82|0.60|0.00001
71092990|NCT00689936|141692990|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.03||||0.70349|TWO_SIDED|95.0|0.89|1.2||The p-value is based on the unstratified log-rank test.|Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|||1.20|0.89|0.70349
70915854|NCT00038103|141322523|SUPERIORITY_OR_OTHER||Objective Response Rate|22.4||||||95.0|11.8|36.6|||||Number of subjects showing objective response out of the number of subjects in the evaluable set.|||36.6|11.8|
70915855|NCT00038103|141322523|SUPERIORITY_OR_OTHER||Objective Response Rate|23.5||||||95.0|12.8|37.5|||||Number of subjects showing objective response out of the number of subjects in the evaluable set.|||37.5|12.8|
70915856|NCT00387465|141322541|OTHER|The maximum tolerated dose (MTD) was derived from the number of participants experiencing dose-limiting toxicities in the Phase I arms. The MTD was the dose at which ≤30% of patients experienced DLTs during cycle 1 up to a pre-specified maximal dose of 40 mg/m2 of azacitidine.|Maximum Tolerated Dose|40.0|||||TWO_SIDED||||||||MTD of Azacitidine measured in mg/m\^2|||||
70915857|NCT05012644|141322552|OTHER||Odds Ratio (OR)|1.266|||||TWO_SIDED|95.0|0.715|2.241||||||||2.241|0.715|
70915858|NCT05012644|141322553|OTHER||Odds Ratio (OR)|1.508|||||TWO_SIDED|95.0|0.819|2.774||||||||2.774|0.819|
70915859|NCT01212757|141322561|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|13.4||||0.006|TWO_SIDED|95.0|4.0|22.7|||Cochran-Mantel-Haenszel|2-sided p-value is based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline disease modifying antirheumatic drug (DMARD) use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% confidence interval (CI) is based on a normal approximation to the weighted average.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||22.7|4.0|0.0060
71092991|NCT00689936|141692991|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69|||<|1e-05|TWO_SIDED|95.0|0.59|0.79||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.79|0.59|<0.00001
71092992|NCT00689936|141692991|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||<|1e-05|TWO_SIDED|95.0|0.6|0.81||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.81|0.60|<0.00001
71092993|NCT00689936|141692991|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99||||0.91161|TWO_SIDED|95.0|0.86|1.14||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||1.14|0.86|0.91161
70915860|NCT01212757|141322561|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|18.7||||0.0002|TWO_SIDED|95.0|9.1|28.2|||Cochran-Mantel-Haenszel|2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||28.2|9.1|0.0002
70915861|NCT01212757|141322562|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14||||0.0042|TWO_SIDED|95.0|-0.236|-0.045|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.045|-0.236|0.0042
70915862|NCT01212757|141322562|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.104||||0.032|TWO_SIDED|95.0|-0.199|-0.009|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.009|-0.199|0.0320
70915863|NCT01212757|141322563|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|9.2||||0.0394|TWO_SIDED|95.0|0.5|17.8||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||17.8|0.5|0.0394
70915864|NCT01212757|141322563|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|15.7||||0.0009|TWO_SIDED|95.0|6.7|24.7||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||24.7|6.7|0.0009
70915865|NCT01212757|141322564|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.121||||0.0191|TWO_SIDED|95.0|-0.222|-0.02|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||-0.020|-0.222|0.0191
70915866|NCT01212757|141322564|SUPERIORITY||LS Mean Difference|-0.08||||0.1179|TWO_SIDED|95.0|-0.18|0.02|||ANCOVA||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||0.020|-0.180|0.1179
70915867|NCT01212757|141322565|SUPERIORITY||LS Mean Difference|2.1||||0.0237|TWO_SIDED|95.0|0.28|3.92|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above||3.92|0.28|0.0237
70915868|NCT01212757|141322565|SUPERIORITY||LS Mean Difference|1.36||||0.1388|TWO_SIDED|95.0|-0.44|3.15|||ANCOVA||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above||3.15|-0.44|0.1388
70915869|NCT01212757|141322566|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|14.9||||0.0065|TWO_SIDED|95.0|4.3|25.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||25.5|4.3|0.0065
70915870|NCT01212757|141322566|SUPERIORITY||Adjusted Difference|14.7||||0.0071|TWO_SIDED|95.0|4.1|25.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||25.2|4.1|0.0071
71092994|NCT00689936|141692992|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78||||0.00234|TWO_SIDED|95.0|0.67|0.92||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.92|0.67|0.00234
71092995|NCT00689936|141692992|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.02||||0.82903|TWO_SIDED|95.0|0.86|1.2||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||1.20|0.86|0.82903
70915871|NCT01212757|141322567|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.9||||0.0648|TWO_SIDED|95.0|-10.0|0.3|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.3|-10.0|0.0648
70915872|NCT01212757|141322567|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.5||||0.0347|TWO_SIDED|95.0|-10.6|-0.4|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.4|-10.6|0.0347
70915873|NCT01212757|141322568|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.3496|TWO_SIDED|95.0|-1.2|0.4|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.4|-1.2|0.3496
70915874|NCT01212757|141322568|SUPERIORITY||LS Mean Difference|0.1||||0.8874|TWO_SIDED|95.0|-0.7|0.8|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.8|-0.7|0.8874
70915875|NCT01212757|141322569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.5438|TWO_SIDED|95.0|-1.0|0.5|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.5|-1.0|0.5438
70915876|NCT01212757|141322569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.3759|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||1.0|-0.4|0.3759
70915877|NCT01212757|141322570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.51||||0.0035|TWO_SIDED|95.0|-5.86|-1.16|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-1.16|-5.86|0.0035
70915878|NCT01212757|141322570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.45||||0.0002|TWO_SIDED|95.0|-6.76|-2.14|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-2.14|-6.76|0.0002
70915879|NCT01212757|141322571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.0004|TWO_SIDED|95.0|-0.61|-0.18|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.18|-0.61|0.0004
70915880|NCT01212757|141322571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|||<|0.0001|TWO_SIDED|95.0|-0.68|-0.25|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.25|-0.68|<0.0001
70915881|NCT01212757|141322572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.12||||0.0318|TWO_SIDED|95.0|0.19|4.06|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||4.06|0.19|0.0318
70915882|NCT01212757|141322572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.27||||0.7803|TWO_SIDED|95.0|-1.65|2.2|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||2.20|-1.65|0.7803
70915883|NCT01212757|141322573|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.86||||0.0473|TWO_SIDED|95.0|0.02|3.7|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||3.70|0.02|0.0473
71092996|NCT00689936|141692992|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.00119|TWO_SIDED|95.0|0.66|0.9||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.90|0.66|0.00119
70915884|NCT01212757|141322573|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.53||||0.0997|TWO_SIDED|95.0|-0.29|3.35|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||3.35|-0.29|0.0997
70915885|NCT01212757|141322574|SUPERIORITY||Adjusted Difference|7.8||||0.1195|TWO_SIDED|95.0|-1.9|17.5||The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Cochran-Mantel-Haenszel||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||17.5|-1.9|0.1195
70915886|NCT01212757|141322574|SUPERIORITY||Adjusted Difference|15.5||||0.0026|TWO_SIDED|95.0|5.6|25.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||25.5|5.6|0.0026
70915887|NCT01212757|141322575|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.7||||0.5067|TWO_SIDED|95.0|-6.8|3.4|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||3.4|-6.8|0.5067
70915888|NCT01212757|141322575|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-3.5||||0.1762|TWO_SIDED|95.0|-8.5|1.6|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||1.6|-8.5|0.1762
70915889|NCT01212757|141322576|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.2719|TWO_SIDED|95.0|-1.2|0.3|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.3|-1.2|0.2719
70915890|NCT01212757|141322576|SUPERIORITY||LS Mean Difference|0.0||||0.9727|TWO_SIDED|95.0|-0.8|0.7|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.7|-0.8|0.9727
70915891|NCT01212757|141322577|SUPERIORITY||LS Mean Difference|-0.3||||0.3705|TWO_SIDED|95.0|-1.0|0.4|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.4|-1.0|0.3705
71092997|NCT00689936|141692993|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.83|||<|1e-05|TWO_SIDED|95.0|1.41|2.37|||Fisher Exact|||||2.37|1.41|<0.00001
71092998|NCT00689936|141692993|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.1||||0.53065|TWO_SIDED|95.0|0.83|1.44|||Fisher Exact|||||1.44|0.83|0.53065
71092999|NCT00689936|141692993|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.67||||0.0001|TWO_SIDED|95.0|1.29|2.15|||Fisher Exact|||||2.15|1.29|0.00010
71093000|NCT00689936|141692994|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.02|||<|1e-05|TWO_SIDED|95.0|1.53|2.68|||Fisher Exact|||||2.68|1.53|<0.00001
70915892|NCT01212757|141322577|SUPERIORITY||LS Mean Difference|0.1||||0.6777|TWO_SIDED|95.0|-0.6|0.8|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.8|-0.6|0.6777
70915893|NCT01212757|141322578|SUPERIORITY||LS Mean Difference|-3.14||||0.0097|TWO_SIDED|95.0|-5.52|-0.76|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.76|-5.52|0.0097
70915894|NCT01212757|141322578|SUPERIORITY||LS Mean Difference|-4.5||||0.0002|TWO_SIDED|95.0|-6.85|-2.16|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-2.16|-6.85|0.0002
70915895|NCT01212757|141322579|SUPERIORITY||LS Mean Difference|-0.38||||0.0011|TWO_SIDED|95.0|-0.6|-0.15|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.15|-0.60|0.0011
70915896|NCT01212757|141322579|SUPERIORITY||LS Mean Difference|-0.45||||0.0001|TWO_SIDED|95.0|-0.68|-0.23|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.23|-0.68|0.0001
70915897|NCT01212757|141322580|SUPERIORITY||LS Mean Difference|2.14||||0.0303|TWO_SIDED|95.0|0.2|4.07|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||4.07|0.20|0.0303
70915898|NCT01212757|141322580|SUPERIORITY||LS mean Difference|0.16||||0.8704|TWO_SIDED|95.0|-1.76|2.08|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||2.08|-1.76|0.8704
70915899|NCT01212757|141322581|SUPERIORITY||Adjusted Difference|3.6||||0.6022|TWO_SIDED|95.0|-9.9|17.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights.|||17.2|-9.9|0.6022
71093001|NCT00689936|141692994|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.14||||0.405|TWO_SIDED|95.0|0.85|1.54|||Fisher Exact|||||1.54|0.85|0.40500
70915900|NCT01212757|141322581|SUPERIORITY||Adjusted Difference|1.3||||0.8462|TWO_SIDED|95.0|-12.1|14.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights.|||14.7|-12.1|0.8462
70915901|NCT01212757|141322582|SUPERIORITY||Adjusted Difference|2.8||||0.7337|TWO_SIDED|95.0|-13.3|18.9|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||18.9|-13.3|0.7337
70915902|NCT01212757|141322582|SUPERIORITY||Adjusted Difference|3.3||||0.6881|TWO_SIDED|95.0|-12.7|19.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||19.3|-12.7|0.6881
70915903|NCT01212757|141322583|SUPERIORITY||Adjusted Difference|17.5||||0.0014|TWO_SIDED|95.0|7.0|27.9|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||27.9|7.0|0.0014
70915904|NCT01212757|141322583|SUPERIORITY||Adjusted Difference|22.1||||0.0001|TWO_SIDED|95.0|11.7|32.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||32.5|11.7|0.0001
70915905|NCT01212757|141322584|SUPERIORITY||Adjusted Difference|6.6||||0.3376|TWO_SIDED|95.0|-6.8|20.0|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||20.0|-6.8|0.3376
70915906|NCT01212757|141322584|SUPERIORITY||Adjusted Difference|6.1||||0.3756|TWO_SIDED|95.0|-7.2|19.4|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||19.4|-7.2|0.3756
70915907|NCT01212757|141322585|SUPERIORITY||Adjusted Difference|6.8||||0.3959|TWO_SIDED|95.0|-8.7|22.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||22.2|-8.7|0.3959
70970743|NCT01964352|141447196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.044|0.116|||Mixed Effects Model for Repeated Measure|||||0.116|0.044|<0.0001
71093002|NCT00689936|141692994|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.77||||4e-05|TWO_SIDED|95.0|1.35|2.32|||Fisher Exact|||||2.32|1.35|0.00004
71093003|NCT00689936|141692995|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||<|1e-05|TWO_SIDED|95.0|0.51|0.76||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.|||0.76|0.51|<0.00001
71093004|NCT00689936|141692995|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||<|1e-05|TWO_SIDED|95.0|0.5|0.72||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.|||0.72|0.50|<0.00001
71093005|NCT00689936|141692995|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.03||||0.7674|TWO_SIDED|95.0|0.86|1.23||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.|||1.23|0.86|0.76740
71093006|NCT00689936|141692996|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.61|||<|1e-05|TWO_SIDED|95.0|0.51|0.72||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.72|0.51|<0.00001
70915908|NCT01212757|141322585|SUPERIORITY||Adjusted Difference|6.8||||0.3941|TWO_SIDED|95.0|-8.7|22.4|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||22.4|-8.7|0.3941
70915909|NCT01212757|141322586|SUPERIORITY||Adjusted Difference|12.1||||0.0142|TWO_SIDED|95.0|2.6|21.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||21.7|2.6|0.0142
70915910|NCT01212757|141322586|SUPERIORITY||Adjusted Difference|20.5||||0.0001|TWO_SIDED|95.0|10.8|30.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||30.3|10.8|0.0001
70915911|NCT01212757|141322587|SUPERIORITY||Adjusted Difference|5.6||||0.0589|TWO_SIDED|95.0|-0.2|11.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||11.3|-0.2|0.0589
70915912|NCT01212757|141322587|SUPERIORITY||Adjusted Difference|9.8||||0.0034|TWO_SIDED|95.0|3.4|16.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||16.1|3.4|0.0034
70915913|NCT01212757|141322588|SUPERIORITY||Adjusted Difference|0.6||||0.562|TWO_SIDED|95.0|-1.5|2.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||2.7|-1.5|0.5620
70915914|NCT01212757|141322588|SUPERIORITY||Adjusted Difference|3.1||||0.057|TWO_SIDED|95.0|0.0|6.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||6.2|-0.0|0.0570
70915915|NCT01212757|141322589|SUPERIORITY||Adjusted Difference|3.1||||0.3629|TWO_SIDED|95.0|-3.5|9.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||9.6|-3.5|0.3629
70915916|NCT01212757|141322589|SUPERIORITY||Adjusted Difference|5.4||||0.1323|TWO_SIDED|95.0|-1.5|12.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||12.3|-1.5|0.1323
70915917|NCT01212757|141322590|SUPERIORITY||Adjusted Difference|-0.6||||0.7273|TWO_SIDED|95.0|-4.3|3.0|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||3.0|-4.3|0.7273
70915918|NCT01212757|141322590|SUPERIORITY||Adjusted Difference|2.4||||0.2929|TWO_SIDED|95.0|-2.0|6.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||6.8|-2.0|0.2929
70915919|NCT01212757|141322591|SUPERIORITY||Adjusted Difference|-2.2||||0.7023|TWO_SIDED|95.0|-13.5|9.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||9.1|-13.5|0.7023
70915920|NCT01212757|141322591|SUPERIORITY||Adjusted Difference|5.9||||0.3305|TWO_SIDED|95.0|-5.9|17.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||17.7|-5.9|0.3305
70915921|NCT01212757|141322592|SUPERIORITY||Adjusted Difference|0.3||||0.9698|TWO_SIDED|95.0|-16.0|16.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||16.6|-16.0|0.9698
70915922|NCT01212757|141322592|SUPERIORITY||Adjusted Difference|1.9||||0.8205|TWO_SIDED|95.0|-14.3|18.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||18.1|-14.3|0.8205
70915923|NCT01212757|141322593|SUPERIORITY||Adjusted Difference|-1.2||||0.8424|TWO_SIDED|95.0|-12.7|10.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||10.3|-12.7|0.8424
70915924|NCT01212757|141322593|SUPERIORITY||Adjusted Difference|5.9||||0.3395|TWO_SIDED|95.0|-6.0|17.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||17.8|-6.0|0.3395
70915925|NCT01212757|141322594|SUPERIORITY||Adjusted Difference|5.9||||0.4811|TWO_SIDED|95.0|-10.3|22.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||22.1|-10.3|0.4811
70915926|NCT01212757|141322594|SUPERIORITY||Adjusted Difference|3.3||||0.6965|TWO_SIDED|95.0|-13.3|19.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||19.5|-13.3|0.6965
70915927|NCT00831272|141322620|SUPERIORITY_OR_OTHER|||||||0.32|||||||Generalized Estimating Equation|||||||0.32
70915928|NCT00516386|141322629|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|543.0|STANDARD_ERROR_OF_MEAN|41.0|<|0.05|||||||Paired t-test|||We used paired t-tests to assess changes in levels of IGF-1 from baseline levels in girls with AN receiving rhIGF-1. Our hypothesis was that rhIGF-1 administration would be associated with a significant increase in IGF-1 levels.||||<0.05
70915929|NCT00516386|141322630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|39.3|STANDARD_ERROR_OF_MEAN|9.3|<|0.05||95.0|||||Paired t-test|||We used a paired t-test to determine the change in P1NP from baseline to 7-10 days following administration of rhIGF-1||||<0.05
70915930|NCT00818454|141322631|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||MMRM ANCOVA|||||||<0.0001
70915931|NCT00818454|141322632|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||MMRM ANCOVA|||||||<0.0001
70915932|NCT00818454|141322633|SUPERIORITY_OR_OTHER|||||||0.159|||||||MMRM ANCOVA|||||||0.159
70915933|NCT00818454|141322634|SUPERIORITY_OR_OTHER|||||||0.8278|||||||MMRM ANCOVA|||||||0.8278
70915934|NCT00818454|141322635|SUPERIORITY_OR_OTHER|||||||0.5098|||||||MMRM ANCOVA|||||||0.5098
70915935|NCT00818454|141322636|SUPERIORITY_OR_OTHER|||||||0.6591|||||||MMRM ANCOVA|||||||0.6591
70915936|NCT00818454|141322637|SUPERIORITY_OR_OTHER|||||||0.3631|||||||MMRM ANCOVA|||||||0.3631
70915937|NCT00818454|141322638|NON_INFERIORITY_OR_EQUIVALENCE|Enter additional comments here, if non-inferiority or equivalence analysis||||||0.6787|||||||MMRM ANCOVA|||||||0.6787
70915938|NCT00818454|141322639|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Mixed Models Analysis|Adjusted for baseline, period, week, and treatment by week interaction||||||0.0001
70915939|NCT00818454|141322640|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||Mixed Models Analysis|Adjusted for baseline, period, week, and treatment by week interaction||||||0.0003
70915940|NCT00549848|141322687|SUPERIORITY|||||||0.778|||||||Cochran-Mantel-Haenszel|||||||0.778
70915941|NCT03262935|141322703|SUPERIORITY||Hazard Ratio (HR)|0.6401|||=|0.002|TWO_SIDED|95.0|0.4885|0.8389||P-value from stratified log-rank test for median estimate of PFS: stratified according to the randomization stratification factors.|Log Rank|||A stratified Cox regression analysis was used to estimate the hazard ratio of PFS, along with 95% CIs. Stratification factors assigned at randomization were world region (Europe, Singapore, and North America), number of prior treatment lines for locally advanced or metastatic breast cancer (excluding hormone therapy) (1 to 2, \>2), and prior treatment with pertuzumab (yes, no).||0.8389|0.4885|=0.002
70915942|NCT03262935|141322704|SUPERIORITY||Hazard Ratio (HR)|0.868|||=|0.236|TWO_SIDED|95.0|0.676|1.1145||P-value from stratified log-rank test for Kaplan-Meier estimate of median OS: stratified according to the randomization stratification factors.|Log Rank|||A stratified Cox regression analysis was used to estimate the hazard ratio of OS, along with 95% CIs. Stratification factors assigned at randomization were world region (Europe, Singapore, and North America), number of prior treatment lines for locally advanced or metastatic breast cancer (excluding hormone therapy) (1 to 2, \>2), and prior treatment with pertuzumab (yes, no).||1.1145|0.676|=0.236
70915943|NCT03262935|141322705|SUPERIORITY||||||=|0.732||||||P-value from Cochran-Mantel-Haenszel test including the randomization stratification factors.|Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel test (strata based on the baseline stratification factors) was used to compare the two treatment groups with respect to the ORR at two-sided 5% level of significance.||||=0.732
70915944|NCT03262935|141322706|SUPERIORITY||Hazard Ratio (HR)|0.5995|||<|0.001|TWO_SIDED|95.0|0.4666|0.7703||P-value from stratified log-rank test for median estimate of PFS: stratified according to the randomization stratification factors.|Log Rank|||A stratified Cox regression analysis was used to estimate the HR of PFS, along with the 95% CI. The treatment groups were compared using the 2-sided stratified log-rank test.||0.7703|0.4666|<0.001
70915945|NCT03262935|141322707|SUPERIORITY|||||||0.473|||||||MMRM|||The change from baseline in the global health status/QoL scale transformed score was analyzed using a mixed model repeated measurement (MMRM) approach.||||0.473
70915946|NCT01811706|141322708|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis is that there was no difference in change of T25FW between Dalfampridine and Placebo. The test was performed with a significant level of 0.05 (two-sided).||||>0.05
70915947|NCT01811706|141322709|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis is that there was no difference in change of SARA score between Dalfampridine and Placebo. The test was performed with a significant level of 0.05 (two-sided).||||>0.05
70915948|NCT01811706|141322710|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis is that there was no difference in change of Stride Length on BAG between Dalfampridine and Placebo. The test was performed with a significant level of 0.05 (two-sided).||||>0.05
70915949|NCT03951649|141322732|SUPERIORITY|||||||0.3|||||||Chi-squared|||||||0.30
70915950|NCT03951649|141322733|SUPERIORITY||||||>|0.99||||||The p-value was calculated using a 2 sided Wilcoxon rank sum test.|Wilcoxon (Mann-Whitney)|||||||>0.99
70915951|NCT03951649|141322734|SUPERIORITY|||||||0.19|||||||Chi-squared|||||||0.19
70915952|NCT03951649|141322735|SUPERIORITY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
70915953|NCT03951649|141322736|SUPERIORITY|||||||1||||||P-value was calculated|Fisher Exact|||||||1.00
70915954|NCT03951649|141322737|SUPERIORITY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||||||0.61
70915955|NCT03951649|141322738|SUPERIORITY|||||||0.43|||||||Fisher Exact|||||||0.43
70915956|NCT03951649|141322740|SUPERIORITY|||||||0.19|||||||Fisher Exact|||||||0.19
70915957|NCT03951649|141322741|SUPERIORITY|||||||0.18|||||||Fisher Exact|||||||0.18
70915958|NCT03951649|141322742|SUPERIORITY|||||||0.92|||||||Fisher Exact|||||||0.92
70915959|NCT03951649|141322743|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
70915960|NCT03951649|141322744|SUPERIORITY|||||||0.14|||||||Fisher Exact|||||||0.14
70915961|NCT03951649|141322745|SUPERIORITY|||||||0.23|||||||Fisher Exact|||||||0.23
70915962|NCT01596504|141322746|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-6.01|STANDARD_ERROR_OF_MEAN|1.06|<|0.0001|ONE_SIDED|95.0|-7.77|||p-values ordered(p1≤p2) as per rules:if p2≤0.05: lixisenatide superior to liraglutide (both doses);if p2\>0.05 \& p1≤0.025:lixisenatide superior to dose of liraglutide associated with p1;if p2\>0.05 \& p1\>0.025:no comparison as statistically significant.|Linear fixed effects model|The threshold for significance at 0.05 level.|Lixisenatide vs Liraglutide 1.2 mg|Analysis was performed using linear fixed effects model with treatment groups and stratification factors (HbA1c levels on Day -7 \[\<8% and \>=8%\], use of metformin at screening \[yes or no\]) and the study site) as fixed effects and baseline plasma glucose AUC from 0.5 to 4.5 hours as covariate. To address multiplicity issue and ensure overall 1-sided level of 5%, Hochberg method was used for testing procedure of comparison between lixisenatide vs liraglutide 1.2 mg or 1.8 mg.|||-7.77|<0.0001
70915963|NCT01596504|141322746|SUPERIORITY_OR_OTHER||LS mean difference|-4.61|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|ONE_SIDED|95.0|-6.34|||p-values ordered(p1≤p2) as per rules:if p2≤0.05:lixisenatide superior to liraglutide (both doses);if p2\>0.05 \& p1≤0.025:lixisenatide superior to dose of liraglutide associated with p1;if p2\>0.05 \& p1\>0.025: no comparison as statistically significant.|Linear fixed effects model|The threshold for significance at 0.05 level.|Lixisenatide vs Liraglutide 1. 8 mg|Analysis was performed using linear mixed effects model with treatment groups and stratification factors (HbA1c levels on Day -7 \[\<8% and \>=8%\], use of metformin at screening \[yes or no\]), and the study site) as fixed effects and baseline plasma glucose AUC from 0.5 to 4.5 hours as covariate. To address multiplicity issue and ensure overall 1-sided level of 5%, Hochberg method was used for testing procedure of comparison between lixisenatide vs liraglutide 1.2 mg or 1.8 mg.|||-6.34|<0.0001
70915964|NCT01901276|141322763|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71|||||||t-test, 2 sided|||Within-individual differences in Shannon indices were tested using paired t tests (normally distributed data).||||0.71
70915965|NCT04347954|141322764|OTHER||Mean Difference (Net)|-0.349|||||TWO_SIDED|95.0|-1.584|0.886||||||Analysis of change in mean Ct values incorporating baseline, hour 1, and day 3 values.||0.886|-1.584|
70915966|NCT04347954|141322764|OTHER||Mean Difference (Net)|-1.059|||||TWO_SIDED|95.0|-2.318|0.201||||||Analysis of change in mean Ct values incorporating baseline, hour 1, and day 3 values.||0.201|-2.318|
70915967|NCT00761930|141322775|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
70915968|NCT00761930|141322776|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
70915969|NCT00761930|141322777|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
70915970|NCT03257813|141322778|NON_INFERIORITY|it will be considered not inferior if they keep the IOP goal with differences of no more than 1.5 mmHg||||||0.013||||||Baseline|t-test, 2 sided|||||||0.013
70915971|NCT03257813|141322778|NON_INFERIORITY|it will be considered not inferior if they keep the IOP goal with differences of no more than 1.5 mmHg||||||0.001||||||CrossOver|t-test, 2 sided|||||||0.001
70915972|NCT03257813|141322778|NON_INFERIORITY|it will be considered not inferior if they keep the IOP goal with differences of no more than 1.5 mmHg||||||0.05||||||Final Visit|t-test, 2 sided|||||||0.050
70915973|NCT03257813|141322779|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 2 points on the snellen scale||||||0.823||||||Baseline|t-test, 2 sided|||||||0.823
70915974|NCT03257813|141322779|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 2 points on the snellen scale||||||0.507||||||CrossOver|t-test, 2 sided|||||||0.507
70915975|NCT03257813|141322779|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 2 points on the snellen scale||||||0.495||||||Final Visit|t-test, 2 sided|||||||0.495
70915976|NCT03257813|141322780|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.085|||||||Chi-squared|||||||0.085
70915977|NCT03257813|141322781|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.001||||||Baseline|Fisher Exact|||||||0.001
70915978|NCT03257813|141322781|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.148||||||CrossOver|Fisher Exact|||||||0.148
70915979|NCT03257813|141322781|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.212||||||Final Visit|Fisher Exact|||||||0.212
70915980|NCT03257813|141322782|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.497||||||Baseline|Chi-squared, Corrected|||||||0.497
70915981|NCT03257813|141322782|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.497||||||CrossOver|Chi-squared, Corrected|||||||0.497
70915982|NCT03257813|141322782|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0||||||"Final Visit~No statistic will be calculated because Final Chemosis is a constant"|Chi-squared, Corrected|||||||0
70915983|NCT03257813|141322783|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||1||||||baseline|Chi-squared|||||||1.000
70915984|NCT03257813|141322783|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.391||||||Cross Over|Chi-squared|||||||0.391
70915985|NCT03257813|141322783|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.534||||||Final Visit|Chi-squared|||||||0.534
70915986|NCT03257813|141322784|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.023||||||Baseline|Chi-squared, Corrected|||||||0.023
70915987|NCT03257813|141322784|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||1||||||CrossOver|Chi-squared|||||||1.000
70915988|NCT03257813|141322784|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.793||||||Final Visit|Chi-squared|||||||0.793
70915989|NCT03257813|141322785|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.825||||||Baseline|Chi-squared|||||||0.825
70915990|NCT03257813|141322785|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||1||||||CrossOver|Chi-squared|||||||1.000
70915991|NCT03257813|141322785|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.765|||||||Chi-squared|||||||0.765
70915992|NCT02878330|141322786|SUPERIORITY||Relative Risk Reduction|70.1|||<|0.0001|TWO_SIDED|95.0|52.3|81.2|||Poisson regression|||||81.2|52.3|<0.0001
70915993|NCT02878330|141322787|SUPERIORITY||Relative Risk Reduction|78.4||||0.0002|TWO_SIDED|95.0|51.9|90.3|||Poisson regression|||||90.3|51.9|0.0002
70915994|NCT02954848|141322797|SUPERIORITY||Median Difference (Final Values)|3.8||||0.0643|TWO_SIDED|95.0|0.0|10.6|||Wilcoxon Rank-Sum Test||The point estimate of the median difference between the treatment groups was calculated using the Hodges-Lehmann estimation.|||10.600|0.000|0.0643
70915995|NCT02954848|141322798|SUPERIORITY|||||||0.0003|||||||Log Rank|||||||0.0003
70915996|NCT02954848|141322799|SUPERIORITY||Median Difference (Final Values)|-0.11||||0.0826|TWO_SIDED|95.0|-0.24|0.01|||Wilcoxon Rank-Sum Test|||||0.0100|-0.2400|0.0826
70915997|NCT02954848|141322800|SUPERIORITY||Median Difference (Final Values)|3.3||||0.0478|TWO_SIDED|95.0|0.0|5.3|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 1, improved response||5.300|0.000|0.0478
70915998|NCT02954848|141322800|SUPERIORITY||Median Difference (Final Values)|0.0||||0.8963|TWO_SIDED|95.0|-6.1|6.0|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 1, not improved response||6.000|-6.100|0.8963
70915999|NCT02954848|141322800|SUPERIORITY||Median Difference (Final Values)|5.2||||0.012|TWO_SIDED|95.0|0.0|10.7|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 2, improved response||10.700|0.000|0.0120
70916000|NCT02954848|141322800|SUPERIORITY||Median Difference (Final Values)|-4.7||||0.0871|TWO_SIDED|95.0|-17.4|0.0|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 2, not improved response||0.000|-17.400|0.0871
70916001|NCT02954848|141322801|SUPERIORITY|||||||0.0025|||||||Log Rank|||||||0.0025
70916002|NCT02954848|141322802|SUPERIORITY|||||||0.1059|||||||Log Rank|||||||0.1059
70916003|NCT02954848|141322803|SUPERIORITY|||||||0.0004|||||||Log Rank|||||||0.0004
71093007|NCT00689936|141692996|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.61|||<|1e-05|TWO_SIDED|95.0|0.52|0.72||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.72|0.52|<0.00001
70916004|NCT02954848|141322804|SUPERIORITY|||||||0.5393|||||||Log Rank|||||||0.5393
70916005|NCT02954848|141322805|SUPERIORITY||Median Difference (Final Values)|-0.1||||0.0505|TWO_SIDED|95.0|-0.21|0.0|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 1, improved response||0.0000|-0.2100|0.0505
70916006|NCT02954848|141322805|SUPERIORITY||Median Difference (Final Values)|0.02||||0.8138|TWO_SIDED|95.0|-0.12|0.15|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 1, not improved response||0.1500|-0.1200|0.8138
70916007|NCT02954848|141322805|SUPERIORITY||Median Difference (Final Values)|-0.15||||0.0129|TWO_SIDED|95.0|-0.28|-0.03|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 2, improved response||-0.0300|-0.2800|0.0129
70916008|NCT02954848|141322805|SUPERIORITY||Median Difference (Final Values)|0.17||||0.0765|TWO_SIDED|95.0|-0.01|0.36|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 2, not improved response||0.3600|-0.0100|0.0765
70916009|NCT02954848|141322806|SUPERIORITY||Median Difference (Final Values)|6.5||||0.149|TWO_SIDED|95.0|-1.9|15.3|||Wilcoxon Rank-Sum Test|||Statistical analysis for Grade N of endoscopic findings||15.300|-1.900|0.1490
70916010|NCT02954848|141322806|SUPERIORITY||Median Difference (Final Values)|3.6||||0.2146|TWO_SIDED|95.0|-1.4|10.7|||Wilcoxon Rank-Sum Test|||Statistical analysis for Grade M of endoscopic findings||10.700|-1.400|0.2146
70916011|NCT02954848|141322807|SUPERIORITY|||||||0.0059|||||||Log Rank|||||||0.0059
70916012|NCT02954848|141322808|SUPERIORITY|||||||0.0153|||||||Log Rank|||||||0.0153
70916013|NCT02954848|141322809|SUPERIORITY||Median Difference (Final Values)|-0.18||||0.0757|TWO_SIDED|95.0|-0.43|0.02|||Wilcoxon Rank-Sum Test|||Statistical analysis for Grade N of endoscopic findings||0.0200|-0.4300|0.0757
70916014|NCT02954848|141322809|SUPERIORITY||Median Difference (Final Values)|-0.07||||0.3837|TWO_SIDED|95.0|-0.22|0.09|||Wilcoxon Rank-Sum Test|||Statistical analysis for Grade M of endoscopic findings||0.0900|-0.2200|0.3837
70916015|NCT02954848|141322810|SUPERIORITY||Median Difference (Final Values)|0.0||||0.6631|TWO_SIDED|95.0|-5.0|3.5|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade N and improved response||3.500|-5.000|0.6631
70916016|NCT02954848|141322810|SUPERIORITY||Median Difference (Final Values)|3.2||||0.5627|TWO_SIDED|95.0|-7.1|13.9|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade N and not improved response||13.900|-7.100|0.5627
70916017|NCT02954848|141322810|SUPERIORITY||Median Difference (Final Values)|3.7||||0.0042|TWO_SIDED|95.0|0.0|8.0|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade M and improved response||8.000|0.000|0.0042
70916018|NCT02954848|141322810|SUPERIORITY||Median Difference (Final Values)|-0.7||||0.6452|TWO_SIDED|95.0|-9.4|6.4|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade M and not improved response||6.400|-9.400|0.6452
70916019|NCT02954848|141322810|SUPERIORITY||Median Difference (Final Values)|7.4||||0.0376|TWO_SIDED|95.0|0.0|17.8|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade N and improved response||17.800|0.000|0.0376
70916020|NCT02954848|141322810|SUPERIORITY||Median Difference (Final Values)|-13.0||||0.16|TWO_SIDED|95.0|-35.7|3.6|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade N and not improved response||3.600|-35.700|0.1600
70916021|NCT02954848|141322810|SUPERIORITY||Median Difference (Final Values)|3.6||||0.1032|TWO_SIDED|95.0|0.0|10.7|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade M and improved response||10.700|0.000|0.1032
70916022|NCT02954848|141322810|SUPERIORITY||Median Difference (Final Values)|-3.3||||0.2613|TWO_SIDED|95.0|-14.3|0.2|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade M and not improved response||0.200|-14.300|0.2613
70916023|NCT02954848|141322811|SUPERIORITY|||||||0.997|||||||Log Rank|||||||0.9970
70916024|NCT02954848|141322812|SUPERIORITY|||||||0.0125|||||||Log Rank|||||||0.0125
70916025|NCT02954848|141322813|SUPERIORITY|||||||0.0004|||||||Log Rank|||||||0.0004
70916026|NCT02954848|141322814|SUPERIORITY|||||||0.7999|||||||Log Rank|||||||0.7999
70916027|NCT02954848|141322815|SUPERIORITY|||||||0.0059|||||||Log Rank|||||||0.0059
70916028|NCT02954848|141322816|SUPERIORITY|||||||0.552|||||||Log Rank|||||||0.5520
70916029|NCT02954848|141322817|SUPERIORITY|||||||0.0175|||||||Log Rank|||||||0.0175
70916030|NCT02954848|141322818|SUPERIORITY|||||||0.7505|||||||Log Rank|||||||0.7505
70916031|NCT02954848|141322819|SUPERIORITY||Median Difference (Final Values)|-0.03||||0.7845|TWO_SIDED|95.0|-0.23|0.16|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade N and improved response||0.1600|-0.2300|0.7845
70916032|NCT02954848|141322819|SUPERIORITY||Wilcoxon Rank-Sum Test|-0.11||||0.4456|TWO_SIDED|95.0|-0.33|0.17|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade N and not improved response||0.1700|-0.3300|0.4456
70916033|NCT02954848|141322819|SUPERIORITY||Median Difference (Final Values)|-0.15||||0.02|TWO_SIDED|95.0|-0.29|-0.02|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade M and improved response||-0.0200|-0.2900|0.0200
70916034|NCT02954848|141322819|SUPERIORITY||Median Difference (Final Values)|0.06||||0.4673|TWO_SIDED|95.0|-0.1|0.22|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade M and not improved response||0.2200|-0.1000|0.4673
70916035|NCT02954848|141322819|SUPERIORITY||Median Difference (Final Values)|-0.29||||0.0095|TWO_SIDED|95.0|-0.53|-0.07|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade N and improved response||-0.0700|-0.5300|0.0095
70916036|NCT02954848|141322819|SUPERIORITY||Median Difference (Final Values)|0.31||||0.165|TWO_SIDED|95.0|-0.16|0.71|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade N and not improved response||0.7100|-0.1600|0.1650
70916037|NCT02954848|141322819|SUPERIORITY||Median Difference (Final Values)|-0.08||||0.2475|TWO_SIDED|95.0|-0.24|0.07|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade M and improved response||0.0700|-0.2400|0.2475
70916038|NCT02954848|141322819|SUPERIORITY||Median Difference (Final Values)|0.13||||0.2367|TWO_SIDED|95.0|-0.09|0.32|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade M and not improved||0.3200|-0.0900|0.2367
70916039|NCT02954848|141322820|SUPERIORITY||Median Difference (Final Values)|5.5||||0.1885|TWO_SIDED|95.0|-2.7|14.3|||Wilcoxon Rank-Sum Test|||Statistical analysis for improved response||14.300|-2.700|0.1885
70916040|NCT02954848|141322820|SUPERIORITY||Wilcoxon Rank-Sum Test|25.6||||0.2337|TWO_SIDED|95.0|-19.2|75.0|||Wilcoxon Rank-Sum Test|||Statistical analysis for not improved response||75.000|-19.200|0.2337
70916041|NCT02954848|141322821|SUPERIORITY|||||||0.0811|||||||Log Rank|||||||0.0811
70916042|NCT02954848|141322822|SUPERIORITY|||||||0.0288|||||||Log Rank|||||||0.0288
70916043|NCT02954848|141322823|SUPERIORITY||Median Difference (Final Values)|-0.17||||0.1488|TWO_SIDED|95.0|-0.42|0.04|||Wilcoxon Rank-Sum Test|||Statistical analysis for improved response||0.0400|-0.4200|0.1488
70916044|NCT02954848|141322823|SUPERIORITY||Wilcoxon Rank-Sum Test|-0.44||||0.3778|TWO_SIDED|95.0|-1.57|0.69|||Wilcoxon Rank-Sum Test|||Statistical analysis for not improved response||0.6900|-1.5700|0.3778
70916045|NCT00922207|141322832|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.6853|TWO_SIDED|95.0|0.46|1.75|||Cochran-Mantel-Haenszel|||||1.75|0.46|0.6853
70916046|NCT00922207|141322832|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.1977|TWO_SIDED|95.0|0.35|1.26|||Cochran-Mantel-Haenszel|||||1.26|0.35|0.1977
70916047|NCT00922207|141322832|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.2916|TWO_SIDED|95.0|0.39|1.38|||Cochran-Mantel-Haenszel|||||1.38|0.39|0.2916
70916048|NCT00922207|141322833|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.34||||0.0353|TWO_SIDED|95.0|0.02|0.66|||ANCOVA|||Baseline||0.66|0.02|0.0353
70916049|NCT00922207|141322833|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.1114|TWO_SIDED|95.0|-0.05|0.52|||ANCOVA|||Baseline||0.52|-0.05|0.1114
70916050|NCT00922207|141322833|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.515|TWO_SIDED|95.0|-0.42|0.21|||ANCOVA|||Baseline||0.21|-0.42|0.5150
70916051|NCT00922207|141322833|SUPERIORITY_OR_OTHER||LS Mean Difference|0.62|||<|0.001|TWO_SIDED|95.0|0.34|0.89|||ANCOVA|||Change at Week 4||0.89|0.34|<0.001
70916052|NCT00922207|141322833|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.92|||<|0.001|TWO_SIDED|95.0|-2.19|-1.65|||ANCOVA|||Change at Week 4||-1.65|-2.19|<0.001
70916053|NCT00922207|141322833|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.54|||<|0.001|TWO_SIDED|95.0|-2.81|-2.27|||ANCOVA|||Change at Week 4||-2.27|-2.81|<0.001
70916054|NCT00922207|141322833|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7|||<|0.001|TWO_SIDED|95.0|1.34|2.06|||ANCOVA|||Change at Week 8||2.06|1.34|<0.001
70916055|NCT00922207|141322833|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.55||||0.0071|TWO_SIDED|95.0|-0.95|-0.15|||ANCOVA|||Change at Week 8||-0.15|-0.95|0.0071
70916056|NCT00922207|141322833|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.26|||<|0.001|TWO_SIDED|95.0|-2.61|-1.9|||ANCOVA|||Change at Week 8||-1.90|-2.61|<0.001
70916057|NCT00922207|141322833|SUPERIORITY_OR_OTHER||LS Mean Difference|1.62|||<|0.001|TWO_SIDED|95.0|1.16|2.08|||ANCOVA|||Change at Week 16||2.08|1.16|<0.001
70916058|NCT00922207|141322833|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.9557|TWO_SIDED|95.0|-0.56|0.53|||ANCOVA|||Change at Week 16||0.53|-0.56|0.9557
70916059|NCT00922207|141322833|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.65|||<|0.001|TWO_SIDED|95.0|-2.15|-1.14|||ANCOVA|||Change at Week 16||-1.14|-2.15|<0.001
70916060|NCT00922207|141322833|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73||||0.0094|TWO_SIDED|95.0|0.18|1.27|||ANCOVA|||Change at Week 28||1.27|0.18|0.0094
70916061|NCT00922207|141322833|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51||||0.0943|TWO_SIDED|95.0|-0.09|1.11|||ANCOVA|||Change at Week 28||1.11|-0.09|0.0943
70916062|NCT00922207|141322833|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.23||||0.4354|TWO_SIDED|95.0|-0.82|0.35|||ANCOVA|||Change at Week 28||0.35|-0.82|0.4354
70916063|NCT00922207|141322833|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36||||0.2509|TWO_SIDED|95.0|-0.26|0.98|||ANCOVA|||Change at Week 40||0.98|-0.26|0.2509
70916064|NCT00922207|141322833|SUPERIORITY_OR_OTHER||LS Mean Difference|0.67||||0.0429|TWO_SIDED|95.0|0.02|1.31|||ANCOVA|||Change at Week 40||1.31|0.02|0.0429
70916065|NCT00922207|141322833|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.3585|TWO_SIDED|95.0|-0.34|0.93|||ANCOVA|||Change at Week 40||0.93|-0.34|0.3585
70916066|NCT00922207|141322833|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04||||0.9014|TWO_SIDED|95.0|-0.65|0.74|||ANCOVA|||Change at Week 52||0.74|-0.65|0.9014
71093008|NCT00689936|141692996|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0||||0.99537|TWO_SIDED|95.0|0.85|1.17||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||1.17|0.85|0.99537
70916067|NCT00922207|141322833|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.1122|TWO_SIDED|95.0|-0.13|1.28|||ANCOVA|||Change at Week 52||1.28|-0.13|0.1122
70916068|NCT00922207|141322833|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51||||0.1602|TWO_SIDED|95.0|-0.2|1.23|||ANCOVA|||Change at Week 52||1.23|-0.20|0.1602
70916069|NCT00922207|141322833|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.49||||0.1599|TWO_SIDED|95.0|-1.17|0.19|||ANCOVA|||Change at Week 64||0.19|-1.17|0.1599
70916070|NCT00922207|141322833|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.5045|TWO_SIDED|95.0|-0.45|0.92|||ANCOVA|||Change at Week 64||0.92|-0.45|0.5045
70916071|NCT00922207|141322833|SUPERIORITY_OR_OTHER||LS Mean Difference|0.72||||0.0412|TWO_SIDED|95.0|0.03|1.41|||ANCOVA|||Change at Week 64||1.41|0.03|0.0412
70916072|NCT00922207|141322833|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54||||0.1347|TWO_SIDED|95.0|-1.24|0.17|||ANCOVA|||Change at Week 76||0.17|-1.24|0.1347
70916073|NCT00922207|141322833|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.4027|TWO_SIDED|95.0|-0.41|1.01|||ANCOVA|||Change at Week 76||1.01|-0.41|0.4027
70916074|NCT00922207|141322833|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81||||0.0311|TWO_SIDED|95.0|0.07|1.55|||ANCOVA|||Change at Week 76||1.55|0.07|0.0311
70916075|NCT00922207|141322833|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.36||||0.3183|TWO_SIDED|95.0|-1.07|0.35|||ANCOVA|||Change at Week 88||0.35|-1.07|0.3183
70916076|NCT00922207|141322833|SUPERIORITY_OR_OTHER||LS Mean Difference|0.52||||0.1371|TWO_SIDED|95.0|-0.17|1.22|||ANCOVA|||Change at Week 88||1.22|-0.17|0.1371
70916077|NCT00922207|141322833|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9||||0.0113|TWO_SIDED|95.0|0.21|1.6|||ANCOVA|||Change at Week 88||1.60|0.21|0.0113
70916078|NCT00922207|141322833|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21||||0.5608|TWO_SIDED|95.0|-0.92|0.5|||ANCOVA|||Change at Week 100||0.50|-0.92|0.5608
70916079|NCT00922207|141322833|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17||||0.6323|TWO_SIDED|95.0|-0.53|0.88|||ANCOVA|||Change at Week 100||0.88|-0.53|0.6323
70916080|NCT00922207|141322833|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.2752|TWO_SIDED|95.0|-0.32|1.11|||ANCOVA|||Change at Week 100||1.11|-0.32|0.2752
70916081|NCT00922207|141322834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.6107|TWO_SIDED|95.0|0.26|9.71|||Cochran-Mantel-Haenszel|||Baseline||9.71|0.26|0.6107
70916082|NCT00922207|141322834|SUPERIORITY_OR_OTHER|||||||0.0788|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Baseline||||0.0788
70916083|NCT00922207|141322834|SUPERIORITY_OR_OTHER|||||||0.1761|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Baseline||||0.1761
70916084|NCT00922207|141322834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.7044|TWO_SIDED|95.0|0.34|5.09|||Cochran-Mantel-Haenszel|||Week 4||5.09|0.34|0.7044
70916085|NCT00922207|141322834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.35||||0.0927|TWO_SIDED|95.0|0.61|46.76|||Cochran-Mantel-Haenszel|||Week 4||46.76|0.61|0.0927
70916086|NCT00922207|141322834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.04||||0.1858|TWO_SIDED|95.0|0.44|36.89|||Cochran-Mantel-Haenszel|||Week 4||36.89|0.44|0.1858
70916087|NCT00922207|141322834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.9385|TWO_SIDED|95.0|0.33|3.38|||Cochran-Mantel-Haenszel|||Week 8||3.38|0.33|0.9385
70916088|NCT00922207|141322834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57||||0.5068|TWO_SIDED|95.0|0.43|5.77|||Cochran-Mantel-Haenszel|||Week 8||5.77|0.43|0.5068
70916089|NCT00922207|141322834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.5544|TWO_SIDED|95.0|0.41|5.5|||Cochran-Mantel-Haenszel|||Week 8||5.50|0.41|0.5544
70916090|NCT00922207|141322834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.651|TWO_SIDED|95.0|0.26|2.31|||Cochran-Mantel-Haenszel|||Week 16||2.31|0.26|0.6510
70916091|NCT00922207|141322834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.3192|TWO_SIDED|95.0|0.2|1.69|||Cochran-Mantel-Haenszel|||Week 16||1.69|0.20|0.3192
70916092|NCT00922207|141322834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.5818|TWO_SIDED|95.0|0.29|2.03|||Cochran-Mantel-Haenszel|||Week 16||2.03|0.29|0.5818
70916093|NCT00922207|141322834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.8796|TWO_SIDED|95.0|0.41|2.66|||Cochran-Mantel-Haenszel|||Week 28||2.66|0.41|0.8796
70916094|NCT00922207|141322834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.305|TWO_SIDED|95.0|0.27|1.52|||Cochran-Mantel-Haenszel|||Week 28||1.52|0.27|0.3050
70916095|NCT00922207|141322834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61||||0.2414|TWO_SIDED|95.0|0.26|1.44|||Cochran-Mantel-Haenszel|||Week 28||1.44|0.26|0.2414
70916096|NCT00922207|141322834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.8502|TWO_SIDED|95.0|0.5|2.22|||Cochran-Mantel-Haenszel|||Week 40||2.22|0.50|0.8502
70916097|NCT00922207|141322834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.5|TWO_SIDED|95.0|0.38|1.61|||Cochran-Mantel-Haenszel|||Week 40||1.61|0.38|0.5000
70916098|NCT00922207|141322834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.3882|TWO_SIDED|95.0|0.36|1.53|||Cochran-Mantel-Haenszel|||Week 40||1.53|0.36|0.3882
70916099|NCT00922207|141322834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.9584|TWO_SIDED|95.0|0.5|1.99|||Cochran-Mantel-Haenszel|||Week 52||1.99|0.50|0.9584
70916100|NCT00922207|141322834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.2576|TWO_SIDED|95.0|0.35|1.34|||Cochran-Mantel-Haenszel|||Week 52||1.34|0.35|0.2576
70916101|NCT00922207|141322834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.2362|TWO_SIDED|95.0|0.36|1.34|||Cochran-Mantel-Haenszel|||Week 52||1.34|0.36|0.2362
70916102|NCT00922207|141322834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.9861|TWO_SIDED|95.0|0.49|1.9|||Cochran-Mantel-Haenszel|||Week 64||1.90|0.49|0.9861
70916103|NCT00922207|141322834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.2919|TWO_SIDED|95.0|0.37|1.35|||Cochran-Mantel-Haenszel|||Week 64||1.35|0.37|0.2919
70916104|NCT00922207|141322834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.2674|TWO_SIDED|95.0|0.38|1.38|||Cochran-Mantel-Haenszel|||Week 64||1.38|0.38|0.2674
70916105|NCT00922207|141322834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.6148|TWO_SIDED|95.0|0.43|1.64|||Cochran-Mantel-Haenszel|||Week 76||1.64|0.43|0.6148
70916106|NCT00922207|141322834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.57||||0.0904|TWO_SIDED|95.0|0.3|1.08|||Cochran-Mantel-Haenszel|||Week 76||1.08|0.30|0.0904
71093009|NCT00689936|141692997|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||||||<0.00001
71093010|NCT00689936|141692997|SUPERIORITY_OR_OTHER_LEGACY|||||||0.46672|||||||Wilcoxon (Mann-Whitney)|||||||0.46672
70916107|NCT00922207|141322834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||0.2073|TWO_SIDED|95.0|0.36|1.27|||Cochran-Mantel-Haenszel|||Week 76||1.27|0.36|0.2073
70916108|NCT00922207|141322834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.998|TWO_SIDED|95.0|0.52|1.98|||Cochran-Mantel-Haenszel|||Week 88||1.98|0.52|0.9980
70916109|NCT00922207|141322834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.3489|TWO_SIDED|95.0|0.39|1.4|||Cochran-Mantel-Haenszel|||Week 88||1.40|0.39|0.3489
70916110|NCT00922207|141322834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.2847|TWO_SIDED|95.0|0.38|1.38|||Cochran-Mantel-Haenszel|||Week 88||1.38|0.38|0.2847
70916111|NCT00922207|141322834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.5596|TWO_SIDED|95.0|0.44|1.62|||Cochran-Mantel-Haenszel|||Week 100||1.62|0.44|0.5596
70916112|NCT00922207|141322834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.2112|TWO_SIDED|95.0|0.36|1.27|||Cochran-Mantel-Haenszel|||Week 100||1.27|0.36|0.2112
70916113|NCT00922207|141322834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.4066|TWO_SIDED|95.0|0.43|1.48|||Cochran-Mantel-Haenszel|||Week 100||1.48|0.43|0.4066
70916114|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.6921|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Baseline||||0.6921
70916115|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.11||||0.3939|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Baseline||||0.3939
70916116|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.6818|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Baseline||||0.6818
70916117|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.7582|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 6||||0.7582
70916118|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.5381|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 6||||0.5381
70916119|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.7747|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 6||||0.7747
70916120|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.8034|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||0.8034
70916121|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.6306|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||0.6306
70916122|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.4574|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||0.4574
70916123|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.5824|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16||||0.5824
70916124|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.9321|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16||||0.9321
70916125|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.5263|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16||||0.5263
70916126|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.2025|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 22||||0.2025
70916127|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.6702|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 22||||0.6702
70916128|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77||||0.0818|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 22||||0.0818
70916129|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.6214|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||0.6214
70916130|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.6774|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||0.6774
70916131|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.3154|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||0.3154
70916132|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.2709|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 34||||0.2709
70916133|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.3804|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 34||||0.3804
70916134|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.7645|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 34||||0.7645
70916135|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.182|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 40||||0.1820
70916136|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.7167|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 40||||0.7167
70916137|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.3104|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 40||||0.3104
70916138|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.091|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 46||||0.0910
70916139|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.6094|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 46||||0.6094
70916140|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.2166|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 46||||0.2166
70916141|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.901|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 52||||0.9010
70916142|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.906|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 52||||0.9060
70916143|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.7268|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 52||||0.7268
70916144|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.5372|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 64||||0.5372
70916145|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.1588|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 64||||0.1588
70916146|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.4268|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 64||||0.4268
70916147|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.4389|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 76||||0.4389
70916148|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.6708|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 76||||0.6708
70916149|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.2145|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 76||||0.2145
70916150|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.8608|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 88||||0.8608
70916151|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52||||0.0283|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 88||||0.0283
70916152|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53||||0.0369|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 88||||0.0369
70916153|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.4606|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 100||||0.4606
70916154|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||0.0832|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 100||||0.0832
71093011|NCT00689936|141692997|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||||||<0.00001
70916155|NCT00922207|141322836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.2655|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 100||||0.2655
70916156|NCT00922207|141322837|SUPERIORITY_OR_OTHER||LS Mean Difference|0.21||||0.0649|TWO_SIDED|95.0|-0.01|0.43|||ANCOVA|||Baseline||0.43|-0.01|0.0649
70916157|NCT00922207|141322837|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.1867|TWO_SIDED|95.0|-0.06|0.33|||ANCOVA|||Baseline||0.33|-0.06|0.1867
70916158|NCT00922207|141322837|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.5003|TWO_SIDED|95.0|-0.3|0.15|||ANCOVA|||Baseline||0.15|-0.30|0.5003
70916159|NCT00922207|141322837|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.2259|TWO_SIDED|95.0|-0.22|0.05|||ANCOVA|||Change at Week 4||0.05|-0.22|0.2259
70916160|NCT00922207|141322837|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|||<|0.001|TWO_SIDED|95.0|-0.36|-0.11|||ANCOVA|||Change at Week 4||-0.11|-0.36|<0.001
70916161|NCT00922207|141322837|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.15||||0.0085|TWO_SIDED|95.0|-0.27|-0.04|||ANCOVA|||Change at Week 4||-0.04|-0.27|0.0085
70916162|NCT00922207|141322837|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.816|TWO_SIDED|95.0|-0.22|0.18|||ANCOVA|||Change at Week 8||0.18|-0.22|0.8160
70916163|NCT00922207|141322837|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.4393|TWO_SIDED|95.0|-0.27|0.12|||ANCOVA|||Change at Week 8||0.12|-0.27|0.4393
70916164|NCT00922207|141322837|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06||||0.489|TWO_SIDED|95.0|-0.22|0.11|||ANCOVA|||Change at Week 8||0.11|-0.22|0.4890
70916165|NCT00922207|141322837|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08||||0.4656|TWO_SIDED|95.0|-0.14|0.3|||ANCOVA|||Change at Week 16||0.30|-0.14|0.4656
70916166|NCT00922207|141322837|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08||||0.5016|TWO_SIDED|95.0|-0.15|0.31|||ANCOVA|||Change at Week 16||0.31|-0.15|0.5016
70916167|NCT00922207|141322837|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01||||0.9582|TWO_SIDED|95.0|-0.23|0.22|||ANCOVA|||Change at Week 16||0.22|-0.23|0.9582
70916168|NCT00922207|141322837|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07||||0.6214|TWO_SIDED|95.0|-0.21|0.36|||ANCOVA|||Change at Week 28||0.36|-0.21|0.6214
70916169|NCT00922207|141322837|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.5493|TWO_SIDED|95.0|-0.21|0.39|||ANCOVA|||Change at Week 28||0.39|-0.21|0.5493
70916170|NCT00922207|141322837|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.8881|TWO_SIDED|95.0|-0.28|0.32|||ANCOVA|||Change at Week 28||0.32|-0.28|0.8881
70916171|NCT00922207|141322837|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.7912|TWO_SIDED|95.0|-0.36|0.27|||ANCOVA|||Change at Week 40||0.27|-0.36|0.7912
70916172|NCT00922207|141322837|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.5427|TWO_SIDED|95.0|-0.24|0.46|||ANCOVA|||Change at Week 40||0.46|-0.24|0.5427
70916173|NCT00922207|141322837|SUPERIORITY_OR_OTHER||LS Mean Difference|0.15||||0.3788|TWO_SIDED|95.0|-0.19|0.49|||ANCOVA|||Change at Week 40||0.49|-0.19|0.3788
71093012|NCT00689936|141692998|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||||||<0.00001
70916174|NCT00922207|141322837|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09||||0.6172|TWO_SIDED|95.0|-0.44|0.26|||ANCOVA|||Change at Week 52||0.26|-0.44|0.6172
70916175|NCT00922207|141322837|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.6002|TWO_SIDED|95.0|-0.29|0.5|||ANCOVA|||Change at Week 52||0.50|-0.29|0.6002
70916176|NCT00922207|141322837|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19||||0.3101|TWO_SIDED|95.0|-0.18|0.56|||ANCOVA|||Change at Week 52||0.56|-0.18|0.3101
70916177|NCT00922207|141322837|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14||||0.4256|TWO_SIDED|95.0|-0.47|0.2|||ANCOVA|||Change at Week 64||0.20|-0.47|0.4256
70916178|NCT00922207|141322837|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01||||0.9762|TWO_SIDED|95.0|-0.35|0.36|||ANCOVA|||Change at Week 64||0.36|-0.35|0.9762
70916179|NCT00922207|141322837|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.4504|TWO_SIDED|95.0|-0.21|0.47|||ANCOVA|||Change at Week 64||0.47|-0.21|0.4504
70916180|NCT00922207|141322837|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.12||||0.4076|TWO_SIDED|95.0|-0.42|0.17|||ANCOVA|||Change at Week 76||0.17|-0.42|0.4076
70916181|NCT00922207|141322837|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05||||0.7591|TWO_SIDED|95.0|-0.37|0.27|||ANCOVA|||Change at Week 76||0.27|-0.37|0.7591
70916182|NCT00922207|141322837|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08||||0.6449|TWO_SIDED|95.0|-0.25|0.4|||ANCOVA|||Change at Week 76||0.40|-0.25|0.6449
70916183|NCT00922207|141322837|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06||||0.7108|TWO_SIDED|95.0|-0.36|0.25|||ANCOVA|||Change at Week 88||0.25|-0.36|0.7108
70916184|NCT00922207|141322837|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12||||0.4725|TWO_SIDED|95.0|-0.22|0.47|||ANCOVA|||Change at Week 88||0.47|-0.22|0.4725
70916185|NCT00922207|141322837|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19||||0.2439|TWO_SIDED|95.0|-0.13|0.5|||ANCOVA|||Change at Week 88||0.50|-0.13|0.2439
70916186|NCT00922207|141322837|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.1862|TWO_SIDED|95.0|-0.1|0.5|||ANCOVA|||Change at Week 100||0.50|-0.10|0.1862
70916187|NCT00922207|141322837|SUPERIORITY_OR_OTHER||LS Mean Difference|0.15||||0.3057|TWO_SIDED|95.0|-0.14|0.43|||ANCOVA|||Change at Week 100||0.43|-0.14|0.3057
70916188|NCT00922207|141322837|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.8002|TWO_SIDED|95.0|-0.38|0.29|||ANCOVA|||Change at Week 100||0.29|-0.38|0.8002
70916189|NCT02326649|141322845|OTHER|||||||0.47|||||||paired t-test|||||||0.47
70916190|NCT02326649|141322845|OTHER||Mean Difference (Final Values)|6.561|STANDARD_ERROR_OF_MEAN|5.528||0.255|TWO_SIDED|95.0|-5.295|18.417|||Regression, Linear|||Intercept for multilinear regression for difference in stroke volume controlling for difference in heart rate and blood pressure||18.417|-5.295|0.255
70916191|NCT02326649|141322845|OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.417||0.25|TWO_SIDED|95.0|-0.395|1.395|||Regression, Linear|||Heart rate delta for multilinear regression for difference in stroke volume controlling for difference in heart rate and blood pressure||1.395|-0.395|0.250
71093013|NCT00689936|141692998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.46987|||||||Wilcoxon (Mann-Whitney)|||||||0.46987
71093014|NCT00689936|141692998|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||||||<0.00001
71093015|NCT00689936|141692999|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.00012|TWO_SIDED|95.0|0.68|0.88||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.88|0.68|0.00012
71093016|NCT00689936|141692999|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81||||0.00187|TWO_SIDED|95.0|0.71|0.93||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.93|0.71|0.00187
70916192|NCT02326649|141322845|OTHER||Mean Difference (Final Values)|-0.427|STANDARD_ERROR_OF_MEAN|0.305||0.183|TWO_SIDED|95.0|-1.081|0.227|||Regression, Linear|||Diastolic BP delta for multilinear regression for difference in stroke volume controlling for difference in heart rate and blood pressure||0.227|-1.081|0.183
70916193|NCT02326649|141322845|OTHER||Mean Difference (Final Values)|0.557|STANDARD_ERROR_OF_MEAN|0.452||0.238|TWO_SIDED|95.0|-0.411|1.526|||Regression, Linear|||Systolic BP delta for multilinear regression for difference in stroke volume controlling for difference in heart rate and blood pressure||1.526|-0.411|0.238
70916194|NCT03698708|141322848|SUPERIORITY||cohen's d|0.88|||||TWO_SIDED||||||repeated measures ANOVA|||||||
70916195|NCT03698708|141322849|SUPERIORITY||cohen's d|0.22|||||TWO_SIDED||||||repeated measures ANOVA|||||||
70916196|NCT03698708|141322850|SUPERIORITY||cohen's d|0.05|||||TWO_SIDED||||||repeated measures ANOVA|||||||
70916197|NCT03698708|141322851|SUPERIORITY||cohen's d|0.14|||||TWO_SIDED||||||repeated measures ANOVA|||||||
70916198|NCT03698708|141322852|SUPERIORITY||cohen's d|0.09|||||TWO_SIDED||||||repeated measures ANOVA|||||||
70916199|NCT03698708|141322853|SUPERIORITY||Mean Difference (Final Values)|-4.16|||||TWO_SIDED|95.0|-10.07|1.74|||ANOVA|||||1.74|-10.07|
70916200|NCT03495713|141322857|OTHER||||||||||||||||||Descriptive analysis only based limited enrollments.|||
70916201|NCT04001517|141322858|SUPERIORITY||Mean Difference (Net)|0.175||||0.049|TWO_SIDED|95.0|0.001|0.345||The comparison is of neflamapimod 40mg TID to placebo. The p-value was not adjusted for multiple comparisons.|Mixed Models Analysis||The comparison is of neflamapimod 40mg TID to placebo. The positive value represents a better outcome with neflamapimod 40mg treatment vs. placebo.|This was an exploratory trial and no explicit a priori hypothesis was established and contained in the protocol. As such, no formal power calculations were conducted. The primary objective of the study was to evaluate the effects of neflamapimod on cognition, and accordingly the primary endpoint was change in combined z-score of the six tests in the NTB, analyzed by Linear Mixed Effects (LME) model for repeated measures.||0.345|0.001|0.049
70916202|NCT04001517|141322858|SUPERIORITY|Comparison of combined neflamapimod groups vs. placebo.|||||>|0.2|||||||Mixed Models Analysis|||||||>0.2
70916203|NCT04001517|141322859|SUPERIORITY|Comparison of combined neflamapimod 40mg TID vs. placebo. The p-value is not adjusted for multiple comparisons.|Mean Difference (Net)|-0.56||||0.007|TWO_SIDED|95.0|-0.96|-0.16||Comparison of combined neflamapimod dose groups vs. placebo utilizing mixed model for repeated measures with baseline as a covariate. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis||The comparison is of neflamapimod 40mg TID to placebo. A negative value indicates improvement compared to placebo.|||-0.16|-0.96|0.007
71093017|NCT00689936|141692999|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.95||||0.45973|TWO_SIDED|95.0|0.84|1.08||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||1.08|0.84|0.45973
70916204|NCT04001517|141322859|SUPERIORITY||Mean Difference (Net)|-0.45||||0.023|TWO_SIDED|95.0|-0.83|-0.06||Mixed model for repeated measures with baseline as a covariate. The p-value was not adjusted for multiple comparisons|Mixed Models Analysis||Comparison of combined neflamapimod dose groups vs. placebo. Negative values represents a better outcome with neflamapimod relative to placebo.|A secondary analysis was conducted comparing the combined neflamapimod dose groups vs. placebo.||-0.06|-0.83|0.023
70916205|NCT04001517|141322860|SUPERIORITY||||||>|0.2|||||||Mixed Models Analysis|||||||>0.2
70916206|NCT04001517|141322861|OTHER||Mean Difference (Net)|-1.53||||0.15|TWO_SIDED|95.0|-3.61|0.55|||Mixed Models Analysis|||||.55|-3.61|0.15
70916207|NCT04001517|141322861|SUPERIORITY||Mean Difference (Net)|-1.31||||0.077|TWO_SIDED|95.0|-5.03|2.34|||Mixed Models Analysis|||Comparison of combined neflamapimod groups (i.e., all neflamapimod) vs. placebo||2.34|-5.03|0.077
70916208|NCT04001517|141322862|SUPERIORITY||Mean Difference (Net)|0.32|||>|0.2|TWO_SIDED|95.0|-1.27|1.91|||Mixed Models Analysis||Comparison of change from baseline over course of study for NFMD 40mg TID vs. placebo.|||1.91|-1.27|>0.2
70916209|NCT04001517|141322863|OTHER||Mean Difference (Net)|-1.4||||0.024|TWO_SIDED|95.0|-2.6|-0.2|||Mixed Models Analysis||Mean difference for the comparison of 40 mg TID vs. placebo is reported.|||-0.2|-2.6|0.024
70916210|NCT04001517|141322863|SUPERIORITY|Comparison of combined neflamapimod dose groups vs. placebo.|Mean Difference (Net)|-1.36||||0.044|TWO_SIDED|95.0|-2.69|-0.04|||Mixed Models Analysis|||||-0.04|-2.69|0.044
70916211|NCT02194933|141322877|SUPERIORITY_OR_OTHER|||||||0.3992||||||Test for Baseline vs. Week 6|Mixed Models Analysis|||||||0.3992
70916212|NCT02194933|141322878|SUPERIORITY_OR_OTHER|||||||0.0053||||||Test for Baseline vs. Week 6|Mixed Models Analysis|||||||0.0053
70916213|NCT02194933|141322880|SUPERIORITY_OR_OTHER|||||||0.1559|||||||Mixed Models Analysis|||||||0.1559
70916214|NCT02194933|141322880|SUPERIORITY_OR_OTHER|||||||0.6201|||||||Mixed Models Analysis|||||||0.6201
70916215|NCT02194933|141322881|SUPERIORITY_OR_OTHER|||||||0.1642|||||||Mixed Models Analysis|||||||0.1642
71093018|NCT00689936|141693000|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||2e-05|TWO_SIDED|95.0|0.67|0.86||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.86|0.67|0.00002
70916216|NCT02194933|141322881|SUPERIORITY_OR_OTHER|||||||0.1873|||||||Mixed Models Analysis|||||||0.1873
70916217|NCT02194933|141322884|SUPERIORITY_OR_OTHER|||||||0.2061|||||||Mixed Models Analysis|||||||0.2061
70916218|NCT02194933|141322884|SUPERIORITY_OR_OTHER|||||||0.1778|||||||Mixed Models Analysis|||||||0.1778
70916219|NCT02194933|141322885|SUPERIORITY_OR_OTHER|||||||0.4138|||||||Mixed Models Analysis|||||||0.4138
70916220|NCT02194933|141322885|SUPERIORITY_OR_OTHER|||||||0.3375|||||||Mixed Models Analysis|||||||0.3375
70916221|NCT02194933|141322888|SUPERIORITY_OR_OTHER|||||||0.8437|||||||Mixed Models Analysis|||||||0.8437
70916222|NCT02194933|141322888|SUPERIORITY_OR_OTHER|||||||0.8318|||||||Mixed Models Analysis|||||||0.8318
70916223|NCT02194933|141322889|SUPERIORITY_OR_OTHER|||||||0.6697|||||||Mixed Models Analysis|||||||0.6697
70916224|NCT02194933|141322889|SUPERIORITY_OR_OTHER|||||||0.8829|||||||Mixed Models Analysis|||||||0.8829
71093019|NCT00689936|141693000|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81||||0.00126|TWO_SIDED|95.0|0.72|0.92||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.92|0.72|0.00126
70916225|NCT02194933|141322890|SUPERIORITY_OR_OTHER|||||||0.2301|||||||Mixed Models Analysis|||||||0.2301
70916226|NCT02194933|141322890|SUPERIORITY_OR_OTHER|||||||0.0599|||||||Mixed Models Analysis|||||||0.0599
70916227|NCT02194933|141322891|SUPERIORITY_OR_OTHER|||||||0.1595|||||||Mixed Models Analysis|||||||0.1595
70916228|NCT02194933|141322891|SUPERIORITY_OR_OTHER|||||||0.1211|||||||Mixed Models Analysis|||||||0.1211
70916229|NCT02194933|141322892|SUPERIORITY_OR_OTHER|||||||0.1322|||||||Mixed Models Analysis|||||||0.1322
70916230|NCT02194933|141322892|SUPERIORITY_OR_OTHER|||||||0.2113|||||||Mixed Models Analysis|||||||0.2113
70916231|NCT02194933|141322893|SUPERIORITY_OR_OTHER|||||||0.0578|||||||Mixed Models Analysis|||||||0.0578
70916232|NCT02194933|141322893|SUPERIORITY_OR_OTHER|||||||0.0588|||||||Mixed Models Analysis|||||||0.0588
70916233|NCT02194933|141322894|SUPERIORITY_OR_OTHER|||||||0.1666|||||||Mixed Models Analysis|||||||0.1666
70916234|NCT02194933|141322894|SUPERIORITY_OR_OTHER|||||||0.767|||||||Mixed Models Analysis|||||||0.7670
70916235|NCT02194933|141322895|SUPERIORITY_OR_OTHER|||||||0.7178|||||||Mixed Models Analysis|||||||0.7178
70916236|NCT02194933|141322895|SUPERIORITY_OR_OTHER|||||||0.2336|||||||Mixed Models Analysis|||||||0.2336
70916237|NCT02194933|141322896|SUPERIORITY_OR_OTHER|||||||0.6558|||||||Mixed Models Analysis|||||||0.6558
70916238|NCT02194933|141322896|SUPERIORITY_OR_OTHER|||||||0.9058|||||||Mixed Models Analysis|||||||0.9058
70916239|NCT02194933|141322897|SUPERIORITY_OR_OTHER|||||||0.0078|||||||Mixed Models Analysis|||||||0.0078
70916240|NCT02194933|141322897|SUPERIORITY_OR_OTHER|||||||0.4272|||||||Mixed Models Analysis|||||||0.4272
70916241|NCT02045836|141322910|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|1.03|||||TWO_SIDED|95.0|0.81|1.31|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-1.||1.31|0.81|
70916242|NCT02045836|141322910|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.96|||||TWO_SIDED|95.0|0.8|1.16|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-3||1.16|0.8|
70916243|NCT02045836|141322910|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|1.13|||||TWO_SIDED|95.0|0.92|1.4|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-4||1.4|0.92|
70916244|NCT02045836|141322910|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.96|||||TWO_SIDED|95.0|0.75|1.21|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-5||1.21|0.75|
70916245|NCT02045836|141322910|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.92|||||TWO_SIDED|95.0|0.73|1.16|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-6B||1.16|0.73|
70916246|NCT02045836|141322910|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|1.07|||||TWO_SIDED|95.0|0.89|1.29|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-7F||1.29|0.89|
70916247|NCT02045836|141322910|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.97|||||TWO_SIDED|95.0|0.79|1.19|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-9V||1.19|0.79|
70916248|NCT02045836|141322910|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.97|||||TWO_SIDED|95.0|0.81|1.18|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-14||1.18|0.81|
70916249|NCT02045836|141322910|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.95|||||TWO_SIDED|95.0|0.77|1.16|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-18C||1.16|0.77|
70916250|NCT02045836|141322910|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|1.15|||||TWO_SIDED|95.0|0.95|1.4|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-19A||1.4|0.95|
70916251|NCT02045836|141322910|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|1.03|||||TWO_SIDED|95.0|0.84|1.25|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-19F||1.25|0.84|
71093020|NCT00689936|141693000|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.27704|TWO_SIDED|95.0|0.83|1.06||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||1.06|0.83|0.27704
70916252|NCT02045836|141322910|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.89|||||TWO_SIDED|95.0|0.7|1.12|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-23F||1.12|0.7|
70916253|NCT02045836|141322911|NON_INFERIORITY|Non Inferiority criterion used: UL of the 95% CI for the anti-gE antibodies GMC ratio between the Control group and the Co-Ad group had to be below 1.5|Adjusted GMC|1.02|||||TWO_SIDED|95.0|0.93|1.11|||ANCOVA|Ancova model: adjustment for baseline concentration and age - pooled variance|Adjusted ratios of GMCs between groups (Control group and Co-Ad group)|Adjusted ratios of GMCs between groups (Control group and Co-Ad group) for anti-gE antibody ELISA concentrations||1.11|0.93|
70916254|NCT03399370|141322978|SUPERIORITY|LS Mean Difference (95% CI) from Placebo|Mean Difference (Final Values)|-57.64|||<|0.0001|TWO_SIDED|95.0|-60.86|-54.43||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-54.43|-60.86|<.0001
70916255|NCT03399370|141322979|SUPERIORITY|LS Mean Difference (95% CI) from Placebo|Mean Difference (Final Values)|-53.78|||<|0.0001|TWO_SIDED|95.0|-56.23|-51.33||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-51.33|-56.23|<0.0001
70916256|NCT03399370|141322980|SUPERIORITY|LS Mean Difference (95% CI) from Placebo|Mean Difference (Final Values)|-54.12|||<|0.0001|TWO_SIDED|95.0|-57.37|-50.88||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-50.88|-57.37|<0.0001
70916257|NCT03399370|141322981|SUPERIORITY||Mean Difference (Final Values)|-53.28|||<|0.0001|TWO_SIDED|95.0|-55.75|-50.8||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-50.80|-55.75|<0.0001
70916258|NCT03399370|141322982|SUPERIORITY||Mean Difference (Final Values)|-83.8|||<|0.0001|TWO_SIDED|95.0|-89.25|-77.34||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-77.34|-89.25|<0.0001
70916259|NCT03399370|141322983|SUPERIORITY||Mean Difference (Final Values)|-33.13|||<|0.0001|TWO_SIDED|95.0|-35.3|-30.97||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-30.97|-35.30|<0.0001
70916260|NCT03399370|141322984|SUPERIORITY||Mean Difference (Final Values)|-43.09|||<|0.0001|TWO_SIDED|95.0|-45.5|-40.67||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-40.67|-45.50|<.0001
70916261|NCT03399370|141322985|SUPERIORITY||Mean Difference (Final Values)|-47.36|||<|0.0001|TWO_SIDED|95.0|-50.25|-44.47||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-44.47|-50.25|<0.0001
70916262|NCT02498769|141322986|OTHER||Hazard Ratio (HR)|0.69||||0.18|TWO_SIDED|95.0|0.41|1.19|||Regression, Cox|||||1.19|0.41|0.18
70916263|NCT02498769|141322987|OTHER||Odds Ratio (OR)|0.63||||0.19|TWO_SIDED|95.0|0.31|1.27|||Regression, Logistic|||||1.27|0.31|0.19
70916264|NCT02498769|141322988|OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||ICU length of stay hours||||.16
70916265|NCT02498769|141322988|OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Hospital LOS||||.51
70916266|NCT02498769|141322989|OTHER|||||||0.97|||||||Chi-squared|||||||.97
70916267|NCT02739035|141322990|SUPERIORITY|A difference of 10 degrees in total mean range of motion between the control and the treatment group was considered a clinically significant improvement.||||||0.23||||||Using a standard alpha value of 0.05, p values below 0.05 were considered statistically significant.|t-test, 2 sided|||"Outcomes were compared between the two study groups using two-sample t-tests. T-tests were two-sided and the standard alpha value of 0.05 was the threshold for statistical significance.~The null hypothesis was that there were no significant differences between control group of MUA alone and the treatment group of MUA with dexamethasone and celecoxib."||||0.23
70916268|NCT02739035|141322991|SUPERIORITY|A difference of 10 degrees in total mean range of motion (ROM) between the control and the treatment group was considered a clinically significant improvement. To detect this difference, a previous study's mean and standard deviation were referenced in order to predict the variation of results. 54 patients per arm were required to have 90% power with a two-sided t-test and a type I error rate of 5%. 130 patients were targeted for recruitment to account for up to a 20% dropout rate.||||||0.81||||||Using a standard alpha value of 0.05, p values below 0.05 were considered statistically significant.|t-test, 2 sided|||"Outcomes were compared between the two study groups using two-sample t-tests. T-tests were two-sided and the standard alpha value of 0.05 was the threshold for statistical significance.~The null hypothesis was that there were no significant differences between control group of MUA alone and the treatment group of MUA with dexamethasone and celecoxib."||||0.81
70916269|NCT05819190|141323010|SUPERIORITY|||||||0.0192|||||||Wilcoxon (Mann-Whitney)|||Comparison of the mean AUC of WURSS-21 scores assessed during the first 8 days of the study between both groups - FAS set||||0.0192
70916270|NCT05819190|141323011|SUPERIORITY|||||||0.0296|||||||Wilcoxon (Mann-Whitney)|||Comparison of the mean AUC of WURSS-21 scores assessed during the first 8 days of the study between both groups - PP set||||0.0296
70916271|NCT05819190|141323012|SUPERIORITY|||||||0.0085|||||||Wilcoxon (Mann-Whitney)|||||||0.0085
70916272|NCT05819190|141323013|SUPERIORITY|||||||0.0081|||||||Wilcoxon (Mann-Whitney)|||||||0.0081
70916273|NCT05819190|141323014|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.0050
70916274|NCT05819190|141323015|SUPERIORITY|||||||0.0107|||||||Wilcoxon (Mann-Whitney)|||||||0.0107
70916275|NCT05819190|141323016|SUPERIORITY|||||||0.0424|||||||Wilcoxon (Mann-Whitney)|||||||0.0424
70916276|NCT05819190|141323017|SUPERIORITY|||||||0.43||||||one sided test|Wilcoxon (Mann-Whitney)|||0.05 global significance level (type I error rate)||||0.430
70916277|NCT05819190|141323018|SUPERIORITY|||||||0.339|||||||Wilcoxon (Mann-Whitney)|one sided test||0.05 global significance level (type I error rate)||||0.339
70916278|NCT05819190|141323019|SUPERIORITY|||||||0.704|||||||Wilcoxon (Mann-Whitney)|one sided test||0.05 global significance level (type I error rate)||||0.704
70916279|NCT05819190|141323020|SUPERIORITY|||||||0.298|||||||Wilcoxon (Mann-Whitney)|One sided test||0.05 global significance level (type I error rate)||||0.298
70916280|NCT05819190|141323021|SUPERIORITY|||||||0.906|||||||Wilcoxon (Mann-Whitney)|one sided test||0.05 global significance level (type I error rate)||||0.906
70916281|NCT05819190|141323022|SUPERIORITY|||||||0.582|||||||Wilcoxon (Mann-Whitney)|one sided test||0.05 global significance level (type I error rate)||||0.582
70916282|NCT05819190|141323023|SUPERIORITY|||||||0.743|||||||Wilcoxon (Mann-Whitney)|one sided test||0.05 global significance level (type I error rate)||||0.743
70916283|NCT05819190|141323024|SUPERIORITY|||||||0.605|||||||Fisher Exact|One sided test||0.05 global significance level (type I error rate)||||0.605
70916284|NCT05819190|141323025|SUPERIORITY|||||||1|||||||Fisher Exact|one sided test||0.05 global significance level (type I error rate)||||1.000
70916285|NCT05819190|141323026|SUPERIORITY|||||||0.988|||||||Fisher Exact|One sided test||0.05 global significance level (type I error rate)||||0.988
70916286|NCT05819190|141323027|SUPERIORITY|||||||0.483|||||||Fisher Exact|one sided test||0.05 global significance level (type I error rate)||||0.483
70916287|NCT02517307|141323028|OTHER|||||||0.136|||||||Mixed Models Analysis|||We compared the effects of intralipid on Rd in controls subjects versus subjects with a FAOD by mixed-effect models. Factors were group (control or FAOD) treatment (glycerol or intralipid) and the interaction of those factors. The hypothesis was intralipid would decrease Rd in controls but not in subjects with an FAOD.||||0.136
70916288|NCT02517307|141323029|OTHER|We analyzed the data with a mixed model looking at the effect of group (control vs FAOD) and treatment (glycerol vs intralipid) and their interaction.||||||0.011|||||||Mixed Models Analysis|||We tested if intralipid did not suppress endogenous glucose production or Ra as much as glycerol in controls compared to subjects with an FAOD.||||0.011
70916289|NCT00667745|141323084|SUPERIORITY||F value, main effect|0.94||||0.33|TWO_SIDED||||||Mixed Models Analysis|||||||0.33
70916290|NCT00667745|141323085|SUPERIORITY||Chi-squared|0.0||||0.967|TWO_SIDED||||||Chi-squared|||||||0.967
70916291|NCT00667745|141323086|SUPERIORITY||Mean Difference (Net)|0.45||||0.5|TWO_SIDED||||||Mixed Models Analysis|||||||0.50
70916292|NCT00667745|141323087|SUPERIORITY||Mean Difference (Net)|0.02||||0.88|TWO_SIDED||||||Mixed Models Analysis|||||||0.88
70916293|NCT00667745|141323088|SUPERIORITY||Mean Difference (Net)|0.92||||0.49|TWO_SIDED|||||Value shown above describes emergent suicidal ideation for participants with baseline MSSI = 0. P=.36 describes exacerbation of baseline suicidal ideation for those with baseline MSSI \> 0.|Mixed Models Analysis|||||||.49
70916294|NCT04493242|141323092|OTHER|log-rank test||||||0.1343|||||||Chi-squared|||||||0.1343
70916295|NCT01942707|141323098|SUPERIORITY||Mean Difference (Final Values)|179.0|STANDARD_DEVIATION|222.0||0.003|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.003
70916296|NCT01942707|141323099|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_DEVIATION|1.9||0.012|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.012
70916297|NCT01942707|141323100|SUPERIORITY||Mean Difference (Final Values)|4.8|STANDARD_DEVIATION|40.7||0.809|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.809
70916298|NCT05147233|141323127|SUPERIORITY||Difference in Percentages|33.2|||<|0.0001|TWO_SIDED|95.0|21.5|44.9|||Wald test|||||44.9|21.5|<0.0001
70916299|NCT05147233|141323128|SUPERIORITY||Difference in Percentages|23.5|||<|0.0001|TWO_SIDED|95.0|11.7|35.3|||Wald test|||||35.3|11.7|<0.0001
70916300|NCT04517864|141323136|SUPERIORITY||Least Squares Mean Difference|0.021|STANDARD_ERROR_OF_MEAN|0.0382|||TWO_SIDED|95.0|-0.056|0.097||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear Mixed-effects Model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||||0.097|-0.056|
70916301|NCT04517864|141323137|SUPERIORITY||Least Squares Mean Difference|0.009|STANDARD_ERROR_OF_MEAN|0.0307|||TWO_SIDED|95.0|-0.052|0.07||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear mixed-effects model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||||0.070|-0.052|
70916302|NCT04517864|141323138|SUPERIORITY||Least Squares Mean Difference|-0.006|STANDARD_ERROR_OF_MEAN|0.0297|||TWO_SIDED|95.0|-0.065|0.053||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear Mixed-effects Model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||||0.053|-0.065|
70916303|NCT04517864|141323140|SUPERIORITY||Least Squares Mean Difference|0.042|STANDARD_ERROR_OF_MEAN|0.0235|||TWO_SIDED|95.0|-0.005|0.088||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear mixed-effects model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||||0.088|-0.005|
70916304|NCT04517864|141323146|SUPERIORITY||Least Squares Mean Difference|-0.015|STANDARD_ERROR_OF_MEAN|0.0224|||TWO_SIDED|95.0|-0.059|0.03||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear mixed-effects model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||Month 6||0.030|-0.059|
70916305|NCT04517864|141323146|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.0236|||TWO_SIDED|95.0|-0.107|-0.012||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear mixed-effects model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||Month 9||-0.012|-0.107|
70916306|NCT04517864|141323148|SUPERIORITY||Least Squares Mean Difference|-0.028|STANDARD_ERROR_OF_MEAN|0.0242|||TWO_SIDED|95.0|-0.076|0.02||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear mixed-effects model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||Month 6||0.020|-0.076|
70916307|NCT04517864|141323148|SUPERIORITY||Least Squares Mean Difference|0.003|STANDARD_ERROR_OF_MEAN|0.0261|||TWO_SIDED|95.0|-0.049|0.056||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear mixed-effects model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||Month 9||0.056|-0.049|
70970744|NCT01964352|141447196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.219|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.181|0.258|||Mixed Effects Model for Repeated Measure|||||0.258|0.181|<0.0001
70916308|NCT01049503|141323193|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||"The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov and Smirnov and Bartlett tests, respectively.~Data were analyzed by 2-way RM-ANOVA after logarithmic transformation and Bonferroni's test."||||<0.05
70916309|NCT01049503|141323194|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Kruskal-Wallis|||The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively. Data from the clinical exams were evaluated by Kruskal-Wallis' test.||||<0.05
70916310|NCT01049503|141323195|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Kruskal-Wallis|||The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively.Data from the clinical exams were evaluated by Kruskal-Wallis' test.||||<0.05
70916311|NCT01049503|141323196|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||"The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov and Smirnov and Bartlett tests, respectively.~Data were analyzed by One-way ANOVA after logarithmic transformation and Tukey's test."||||<0.05
70916312|NCT01049503|141323197|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Kruskal-Wallis|||The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively. Data from fluorescence loss were evaluated by Kruskal-Wallis and Dunn's tests.||||<0.05
70916313|NCT01049503|141323198|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively. Data from lesion area were evaluated by ANOVA after logarithmic transformation and Tukey's test.||||<0.05
70916314|NCT01049503|141323199|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Kruskal-Wallis|||GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively.Data from the clinical exams were evaluated by Kruskal-Wallis' test.||||<0.05
70916315|NCT00726596|141323200|SUPERIORITY|||||||0.6789|||||||t-test, 1 sided|||||||.6789
70916316|NCT02974634|141323212|SUPERIORITY||Slope|1.04|STANDARD_ERROR_OF_MEAN|2.32||0.06|TWO_SIDED|95.0|-3.5|5.6||Comparison of intervention and usual care at 6 month follow up|t-test, 2 sided||Interaction coefficient (slope) of arm by time period (6 months follow up vs baseline) from mixed linear model|||5.6|-3.5|0.06
70916317|NCT02974634|141323213|SUPERIORITY||Slope|0.34|STANDARD_ERROR_OF_MEAN|0.29||0.68|TWO_SIDED|95.0|-0.24|0.91||Comparison of intervention and usual care at 6 month follow up|t-test, 2 sided||Interaction coefficient (slope) of arm by time period (6 months follow up vs baseline) from mixed linear model|||0.91|-0.24|0.68
70916318|NCT02962674|141323225|SUPERIORITY|||||||0.004|||||||t-test, 1 sided|||"The null and alternative hypotheses associated with this objective was written as:~H0: μ ΔIPSS ≤ 6.5 points HA: μ ΔIPSS \> 6.5 points where μ ΔIPSS was the true underlying value of mean ΔIPSS following a treatment at the 3-month follow-up visit and 6.5 points was an objective performance goal (OPG). The objective was met at a given time point by rejecting the null hypothesis in a one-sided t-test at the 5% significance level."||||0.004
70916319|NCT01124188|141323250|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.63|1.8||||||||1.80|0.63|
70916320|NCT01124188|141323251|SUPERIORITY_OR_OTHER|||||||0.49|||||||Mixed Models Analysis|||||||.49
70916321|NCT01124188|141323252|SUPERIORITY_OR_OTHER|||||||0.88|||||||Mixed Models Analysis|||||||0.88
70916322|NCT01324453|141323304|SUPERIORITY|||||||0.9|||||||Kruskal-Wallis|||||||0.90
70916323|NCT01324453|141323305|SUPERIORITY|||||||0.81|||||||Kruskal-Wallis|||||||0.81
70916324|NCT01324453|141323306|SUPERIORITY|||||||0.45|||||||Chi-squared|||||||0.45
70916325|NCT01324453|141323307|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
70916326|NCT01324453|141323308|SUPERIORITY|||||||0.86|||||||Kruskal-Wallis|||||||0.86
70916327|NCT01324453|141323309|SUPERIORITY|||||||1|||||||Kruskal-Wallis|||||||1.00
70916328|NCT01324453|141323310|SUPERIORITY|||||||0.58|||||||Kruskal-Wallis|||||||0.58
70916329|NCT01324453|141323311|SUPERIORITY|||||||0.77|||||||Kruskal-Wallis|||||||0.77
70916330|NCT01227278|141323334|SUPERIORITY_OR_OTHER||Rate ratio|1.03||||0.941|TWO_SIDED|95.0|0.67|1.58|||Van Elteren Test|Day 1 to 393: Van Elteren test was used to compare the two arms.|95 percent (%) confidence interval (CI) for rate ratio was based on normal approximation assuming rate with Poisson distribution.|||1.58|0.67|0.941
70916331|NCT04035668|141323356|SUPERIORITY||Mean Difference (Final Values)|-2.86||||0.002|TWO_SIDED|95.0|-4.71|-1.01||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|||-1.01|-4.71|0.002
70916332|NCT04035668|141323356|OTHER||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-3.24|1.25|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|||1.25|-3.24|
70916333|NCT04035668|141323357|SUPERIORITY||Mean Difference (Final Values)|-0.99||||0.065|TWO_SIDED|95.0|-2.29|0.3||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 2||0.30|-2.29|0.065
70916334|NCT04035668|141323357|SUPERIORITY||Mean Difference (Final Values)|-1.76||||0.01|TWO_SIDED|95.0|-3.24|-0.29||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 4||-0.29|-3.24|0.010
70916335|NCT04035668|141323357|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.289|TWO_SIDED|95.0|-2.17|1.22||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 8||1.22|-2.17|0.289
70916336|NCT04035668|141323357|SUPERIORITY||Mean Difference (Final Values)|-1.19||||0.093|TWO_SIDED|95.0|-2.97|0.59||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 12||0.59|-2.97|0.093
70916337|NCT04035668|141323357|SUPERIORITY||Mean Difference (Final Values)|-1.13||||0.094|TWO_SIDED|95.0|-2.84|0.57||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 16||0.57|-2.84|0.094
70916338|NCT04035668|141323357|SUPERIORITY||Mean Difference (Final Values)|-1.99||||0.012|TWO_SIDED|95.0|-3.71|-0.28||one-sided p-value|MMRM|||Week 20|Difference (Any remibrutinib - Placebo)|-0.28|-3.71|0.012
70916339|NCT04035668|141323357|OTHER||Mean Difference (Final Values)|-0.63|||||TWO_SIDED|95.0|-2.1|0.84|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 2||0.84|-2.10|
70916340|NCT04035668|141323357|OTHER||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-1.75|1.69|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 4||1.69|-1.75|
70916341|NCT04035668|141323357|OTHER||Mean Difference (Final Values)|0.19|||||TWO_SIDED|95.0|-1.83|2.21|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 8||2.21|-1.83|
70916342|NCT04035668|141323357|OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-3.2|1.01|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 12||1.01|-3.20|
70916343|NCT04035668|141323357|OTHER||Mean Difference (Final Values)|-1.45|||||TWO_SIDED|95.0|-3.5|0.6|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 16||0.60|-3.50|
70916344|NCT04035668|141323357|OTHER||Mean Difference (Final Values)|-1.14|||||TWO_SIDED|95.0|-3.22|0.95|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 20||0.95|-3.22|
70916345|NCT04035668|141323358|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.46|TWO_SIDED|95.0|-0.69|0.62||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 2||0.62|-0.69|0.460
70916346|NCT04035668|141323358|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.418|TWO_SIDED|95.0|-0.82|0.66||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 4||0.66|-0.82|0.418
70916347|NCT04035668|141323358|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.466|TWO_SIDED|95.0|-0.76|0.7||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 8||0.70|-0.76|0.466
70916348|NCT04035668|141323358|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.56|TWO_SIDED|95.0|-0.67|0.79||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 12||0.79|-0.67|0.560
70916349|NCT04035668|141323358|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.616|TWO_SIDED|95.0|-0.73|0.99||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 16||0.99|-0.73|0.616
70916350|NCT04035668|141323358|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.581|TWO_SIDED|95.0|-0.81|0.99||one-sided p-value|MMRM|||Week 20|Difference (Any remibrutinib - Placebo)|0.99|-0.81|0.581
70916351|NCT04035668|141323358|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.663|TWO_SIDED|95.0|-0.62|0.96||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 24||0.96|-0.62|0.663
70916352|NCT04035668|141323358|OTHER||Mean Difference (Final Values)|-0.62|||||TWO_SIDED|95.0|-1.35|0.11|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 2||0.11|-1.35|
70916353|NCT04035668|141323358|OTHER||Mean Difference (Final Values)|-0.58|||||TWO_SIDED|95.0|-1.42|0.26|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 4||0.26|-1.42|
70916354|NCT04035668|141323358|OTHER||Mean Difference (Final Values)|-0.45|||||TWO_SIDED|95.0|-1.31|0.42|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 8||0.42|-1.31|
70916355|NCT04035668|141323358|OTHER||Mean Difference (Final Values)|-0.57|||||TWO_SIDED|95.0|-1.44|0.31|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 12||0.31|-1.44|
70916356|NCT04035668|141323358|OTHER||Mean Difference (Final Values)|-0.37|||||TWO_SIDED|95.0|-1.39|0.65|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 16||0.65|-1.39|
70916357|NCT04035668|141323358|OTHER||Mean Difference (Final Values)|-0.37|||||TWO_SIDED|95.0|-1.39|0.65|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 20||0.65|-1.39|
70916358|NCT04035668|141323358|OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-1.37|0.57|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 24||0.57|-1.37|
70916359|NCT04035668|141323359|SUPERIORITY||Mean Difference (Final Values)|-2.73||||0.94|TWO_SIDED|95.0|-6.18|0.73||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 2||0.73|-6.18|0.940
70916360|NCT04035668|141323359|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.322|TWO_SIDED|95.0|-2.95|4.74||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 4||4.74|-2.95|0.322
70916361|NCT04035668|141323359|SUPERIORITY||Mean Difference (Final Values)|-1.36||||0.753|TWO_SIDED|95.0|-5.32|2.59||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 8||2.59|-5.32|0.753
70916362|NCT04035668|141323359|SUPERIORITY||Mean Difference (Final Values)|-2.74||||0.891|TWO_SIDED|95.0|-7.13|1.66||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 12||1.66|-7.13|0.891
70916363|NCT04035668|141323359|SUPERIORITY||Mean Difference (Final Values)|-3.88||||0.941|TWO_SIDED|95.0|-8.77|1.01||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 16||1.01|-8.77|0.941
70916364|NCT04035668|141323359|SUPERIORITY||Mean Difference (Final Values)|1.39||||0.304|TWO_SIDED|95.0|-4.01|6.79||one-sided p-value|MMRM|||Week 20|Difference (Any remibrutinib - Placebo)|6.79|-4.01|0.304
70916365|NCT04035668|141323359|SUPERIORITY||Mean Difference (Final Values)|-1.05||||0.64|TWO_SIDED|95.0|-6.89|4.79||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 24||4.79|-6.89|0.640
70916366|NCT04035668|141323359|OTHER||Mean Difference (Final Values)|2.32|||||TWO_SIDED|95.0|-1.44|6.07|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 2||6.07|-1.44|
70916367|NCT04035668|141323359|OTHER||Mean Difference (Final Values)|0.86|||||TWO_SIDED|95.0|-3.46|5.18|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 4||5.18|-3.46|
70916368|NCT04035668|141323359|OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-4.43|4.83|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 8||4.83|-4.43|
70916369|NCT04035668|141323359|OTHER||Mean Difference (Final Values)|0.63|||||TWO_SIDED|95.0|-4.53|5.78|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 12||5.78|-4.53|
70916370|NCT04035668|141323359|OTHER||Mean Difference (Final Values)|1.11|||||TWO_SIDED|95.0|-4.6|6.82|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 16||6.82|-4.60|
70916371|NCT04035668|141323359|OTHER||Mean Difference (Final Values)|5.69|||||TWO_SIDED|95.0|-0.66|12.04|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 20||12.04|-0.66|
70916372|NCT04035668|141323359|OTHER||Mean Difference (Final Values)|3.53|||||TWO_SIDED|95.0|-3.53|10.59|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 24||10.59|-3.53|
70916373|NCT04035668|141323360|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.494|TWO_SIDED|95.0|-7.84|7.96||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 2||7.96|-7.84|0.494
70916374|NCT04035668|141323360|SUPERIORITY||Mean Difference (Final Values)|-3.87||||0.866|TWO_SIDED|95.0|-10.81|3.06||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 4||3.06|-10.81|0.866
70916375|NCT04035668|141323360|SUPERIORITY||Mean Difference (Final Values)|-1.82||||0.684|TWO_SIDED|95.0|-9.37|5.73||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 8||5.73|-9.37|0.684
70916376|NCT04035668|141323360|SUPERIORITY||Mean Difference (Final Values)|-4.39||||0.908|TWO_SIDED|95.0|-10.93|2.14||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 12||2.14|-10.93|0.908
70916377|NCT04035668|141323360|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.487|TWO_SIDED|95.0|-8.0|8.26||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 16||8.26|-8.00|0.487
70916378|NCT04035668|141323360|SUPERIORITY||Mean Difference (Final Values)|-3.06||||0.79|TWO_SIDED|95.0|-10.61|4.49||one-sided p-value|MMRM|||Week 20|Difference (Any remibrutinib - Placebo)|4.49|-10.61|0.790
70916379|NCT04035668|141323360|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.34|TWO_SIDED|95.0|-6.48|9.88||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 24||9.88|-6.48|0.340
70916380|NCT04035668|141323360|OTHER||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-9.06|8.68|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 2||8.68|-9.06|
70916381|NCT04035668|141323360|OTHER||Mean Difference (Final Values)|-1.71|||||TWO_SIDED|95.0|-9.59|6.17|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 4||6.17|-9.59|
70916382|NCT04035668|141323360|OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-9.34|8.74|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 8||8.74|-9.34|
70916383|NCT04035668|141323360|OTHER||Mean Difference (Final Values)|-3.94|||||TWO_SIDED|95.0|-11.74|3.86|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 12||3.86|-11.74|
70916384|NCT04035668|141323360|OTHER||Mean Difference (Final Values)|-4.71|||||TWO_SIDED|95.0|-14.34|4.93|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 16||4.93|-14.34|
70916385|NCT04035668|141323360|OTHER||Mean Difference (Final Values)|-6.29|||||TWO_SIDED|95.0|-15.44|2.87|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 20||2.87|-15.44|
70916386|NCT04035668|141323360|OTHER||Mean Difference (Final Values)|-3.92|||||TWO_SIDED|95.0|-14.01|6.16|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 24||6.16|-14.01|
70916387|NCT04035668|141323361|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.575|TWO_SIDED|95.0|-6.75|8.16||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 2||8.16|-6.75|0.575
70916388|NCT04035668|141323361|SUPERIORITY||Mean Difference (Final Values)|-1.98||||0.294|TWO_SIDED|95.0|-9.22|5.27||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 4||5.27|-9.22|0.294
70916389|NCT04035668|141323361|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.45|TWO_SIDED|95.0|-8.4|7.41||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 8||7.41|-8.40|0.450
70916390|NCT04035668|141323361|SUPERIORITY||Mean Difference (Final Values)|6.02||||0.913|TWO_SIDED|95.0|-2.74|14.78||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 12||14.78|-2.74|0.913
70916391|NCT04035668|141323361|SUPERIORITY||Mean Difference (Final Values)|2.59||||0.722|TWO_SIDED|95.0|-6.16|11.34||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 16||11.34|-6.16|0.722
70916392|NCT04035668|141323361|SUPERIORITY||Mean Difference (Final Values)|-2.86||||0.241|TWO_SIDED|95.0|-10.96|5.24||one-sided p-value|MMRM|||Week 20|Difference (Any remibrutinib - Placebo)|5.24|-10.96|0.241
70916393|NCT04035668|141323361|SUPERIORITY||Mean Difference (Final Values)|2.95||||0.742|TWO_SIDED|95.0|-6.09|11.99||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 24||11.99|-6.09|0.742
70916394|NCT04035668|141323361|OTHER||Mean Difference (Final Values)|-0.18|||||TWO_SIDED|95.0|-8.28|7.91|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 2||7.91|-8.28|
70916395|NCT04035668|141323361|OTHER||Mean Difference (Final Values)|-0.65|||||TWO_SIDED|95.0|-8.87|7.58|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 4||7.58|-8.87|
70916396|NCT04035668|141323361|OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-9.28|9.48|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 8||9.48|-9.28|
70916397|NCT04035668|141323361|OTHER||Mean Difference (Final Values)|-4.4|||||TWO_SIDED|95.0|-14.71|5.9|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 12||5.90|-14.71|
70916398|NCT04035668|141323361|OTHER||Mean Difference (Final Values)|-12.1|||||TWO_SIDED|95.0|-22.47|-1.77|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 16||-1.77|-22.47|
70916399|NCT04035668|141323361|OTHER||Mean Difference (Final Values)|-6.25|||||TWO_SIDED|95.0|-16.0|3.5|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 20||3.50|-16.00|
70916400|NCT04035668|141323361|OTHER||Mean Difference (Final Values)|-8.1|||||TWO_SIDED|95.0|-19.16|2.96|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 24||2.96|-19.16|
70916401|NCT00465816|141323388|NON_INFERIORITY|The lower limit of the two-sided 95% CI on the ratio of rSBA-MenA GMTs between Nimenrix + Twinrix group and (over) Nimenrix group was ≥ 0.5.|Adjusted GMT ratio|0.99|||||TWO_SIDED|95.0|0.8|1.22|||ANCOVA|||To assess the Non-inferiority in term of rSBA-MenA GMT of the Nimenrix + Twinrix group compared to Nimenrix one, two-sided 95% confidence interval (CI) from ANCOVA model on the GMTs ratio (Nimenrix+Twinrix group over Nimenrix group) was computed. The model was adjusted for age strata and baseline titre.||1.22|0.8|
70916402|NCT00465816|141323388|NON_INFERIORITY|The lower limit of the two-sided 95% CI on the ratio of rSBA-MenC GMTs between Nimenrix + Twinrix group and (over) Nimenrix group was ≥ 0.5.|Adjusted GMT ratio|0.91|||||TWO_SIDED|95.0|0.68|1.21|||ANCOVA|||To assess the Non-inferiority in term of rSBA-MenC GMT of the Nimenrix+Twinrix group compared to Nimenrix one, Two-sided 95% CI from ANCOVA model on the GMTs ratio (Nimenrix+Twinrix group over Nimenrix group) was computed. The model was adjusted for age strata and baseline titre.||1.21|0.68|
70916403|NCT00465816|141323388|NON_INFERIORITY|The lower limit of the two-sided 95% CI on the ratio of rSBA-MenW-135 GMTs between Nimenrix + Twinrix group and (over) Nimenrix group was ≥ 0.5.|Adjusted GMT ratio|1.02|||||TWO_SIDED|95.0|0.87|1.19|||ANCOVA|||To assess the Non-inferiority in term of rSBA-MenW-135 GMT of the Nimenrix+Twinrixg roup compared to Nimenrix one, Two-sided 95% CI from ANCOVA model on the GMTs ratio (Nimenrix+Twinrix group over Nimenrix group) was computed. The model was adjusted for age strata and baseline titre.||1.19|0.87|
70970745|NCT01964352|141447196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.018||0.0872|TWO_SIDED|95.0|-0.005|0.067|||Mixed Effects Model for Repeated Measure|||||0.067|-0.005|0.0872
70970746|NCT01964352|141447197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.0124|0.2|||Mixed Effects Model for Repeated Measure|||||0.200|0.0124|<0.0001
70916404|NCT00465816|141323388|NON_INFERIORITY|The lower limit of the two-sided 95% CI on the ratio of rSBA-MenY GMTs between Nimenrix + Twinrix group and (over) Nimenrix group was ≥ 0.5.|Adjusted GMT ratio|1.01|||||TWO_SIDED|95.0|0.85|1.19|||ANCOVA|||To assess the Non-inferiority in term of rSBA-MenY GMT of the Nimenrix+Twinrix group compared to Nimenrix one, Two-sided 95% CI from ANCOVA model on the GMTs ratio (Nimenrix+Twinrix group over Nimenrix group) was computed. The model was adjusted for age strata and baseline titre.||1.19|0.85|
70916405|NCT00465816|141323389|NON_INFERIORITY|The lower limit of the two-sided standardised asymptotic 95% CI for group difference (Nimenrix+Twinrix group minus Twinrix group) in the percentage of subjects with vaccine seroconversion was ≥ pre-defined clinical limit of -10%.|Percentage difference|0.0|||||TWO_SIDED|95.0|-1.19|3.9||||||To assess the Non-inferiority of the Nimenrix+Twinrix group compared to Twinrix one, two-sided standardized asymptotic 95% CI for the difference in seroconversion rates for hepatitis A (Nimenrix+Twinrix group minus Twinrix group) was computed.||3.9|-1.19|
70916406|NCT00465816|141323390|NON_INFERIORITY|The lower limit of the two-sided standardised asymptotic 95% CI for group difference (Nimenrix+Twinrix group minus Twinrix group) in the percentage of subjects with vaccine seroconversion was ≥ pre-defined clinical limit of -10%.|Percentage difference|-0.91|||||TWO_SIDED|95.0|-2.64|2.92||||||To assess the Non-inferiority of the Nimenrix+Twinrix group compared to the Twinrix one, two-sided standardized asymptotic 95% CI for the difference in seroprotection rates for hepatitis B (Nimenrix+Twinrix group minus Twinrix group) was computed.||2.92|-2.64|
70916407|NCT02477670|141323429|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.79||||0.073|TWO_SIDED|95.0|-3.75|0.17|||Mixed Models Analysis|||Sequential Parallel Comparison Design (SPCD) Weighted Ordinary Least Squares (OLS) z-statistic. Treatment differences in each stage were estimated by the Mixed Model Repeated Measures (MMRM).||0.17|-3.75|0.073
70916408|NCT02477670|141323430|SUPERIORITY||SPCD Weighted OLS z-statistic|-2.25||||0.025|TWO_SIDED|95.0|-4.21|-0.29|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||-0.29|-4.21|0.025
71093021|NCT00689936|141693001|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.66|||<|1e-05|TWO_SIDED|95.0|0.56|0.78||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.78|0.56|<0.00001
71093022|NCT00689936|141693001|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.00067|TWO_SIDED|95.0|0.63|0.88||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.88|0.63|0.00067
70916409|NCT02477670|141323431|SUPERIORITY||SPCD Weighted OLS z-statistic|-2.2||||0.027|TWO_SIDED|95.0|-4.16|-0.24|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||-0.24|-4.16|0.027
70916410|NCT02477670|141323432|SUPERIORITY||SPCD Weighted OLS z-statistic|-2.26||||0.024|TWO_SIDED|95.0|-4.22|-0.3|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||-0.3|-4.22|0.024
70916411|NCT02477670|141323433|SUPERIORITY||SPCD Weighted OLS z-statistic|-2.6||||0.009|TWO_SIDED|95.0|-4.56|-0.64|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||-0.64|-4.56|0.009
70916412|NCT02477670|141323434|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.39||||0.7|TWO_SIDED|95.0|-2.35|1.57|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||1.57|-2.35|0.700
70916413|NCT02477670|141323435|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.93||||0.054|TWO_SIDED|95.0|-3.89|0.03|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||0.03|-3.89|0.054
70916414|NCT02477670|141323436|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.35||||0.723|TWO_SIDED|95.0|-2.31|1.61|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||1.61|-2.31|0.723
70916415|NCT02477670|141323437|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.85||||0.064|TWO_SIDED|95.0|-3.81|0.11|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||0.11|-3.81|0.064
70916416|NCT02477670|141323438|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.64||||0.1|TWO_SIDED|95.0|-3.6|0.32|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||0.32|-3.6|0.100
70916417|NCT02477670|141323439|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.86||||0.388|TWO_SIDED|95.0|-2.82|1.1|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||1.1|-2.82|0.388
70916418|NCT02477670|141323440|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.9||||0.367|TWO_SIDED|95.0|-2.86|1.06|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||1.06|-2.86|0.367
70916419|NCT02477670|141323441|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.76||||0.447|TWO_SIDED|95.0|-2.72|1.2|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||1.2|-2.72|0.447
70916420|NCT02477670|141323442|SUPERIORITY||SPCD Weighted OLS z-statistic|-2.23||||0.026|TWO_SIDED|95.0|-4.19|-0.27|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||-0.27|-4.19|0.026
70916421|NCT02477670|141323443|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.62||||0.106|TWO_SIDED|95.0|-3.58|0.34|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||0.34|-3.58|0.106
70916422|NCT02477670|141323444|SUPERIORITY||SPCD Weighted OLS z-statistic|1.78||||0.074|TWO_SIDED|95.0|-0.18|3.74|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||3.74|-0.18|0.074
71093023|NCT00689936|141693001|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.12333|TWO_SIDED|95.0|0.75|1.03||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||1.03|0.75|0.12333
70916423|NCT02477670|141323445|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.79||||0.427|TWO_SIDED|95.0|-2.75|1.17|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||1.17|-2.75|0.427
70916424|NCT02477670|141323446|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.91||||0.0566|TWO_SIDED|95.0|-3.87|0.05|||McNemar|||Treatment differences in each stage were estimated by the MMRM.||0.05|-3.87|0.0566
70916425|NCT02477670|141323447|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.37||||0.17|TWO_SIDED|95.0|-3.33|0.59|||ANCOVA|||||0.59|-3.33|0.1700
71093024|NCT00689936|141693002|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||<|1e-05|TWO_SIDED|95.0|0.54|0.73||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.|||.73|0.54|<0.00001
71093025|NCT00689936|141693002|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||1e-05|TWO_SIDED|95.0|0.61|0.83||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.|||0.83|0.61|0.00001
70916426|NCT02477670|141323448|SUPERIORITY||SPCD Weighted OLS z-statistic|0.53||||0.595|TWO_SIDED|95.0|-1.43|2.49|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||2.49|-1.43|0.595
70916427|NCT02477670|141323449|SUPERIORITY||SPCD Weighted OLS z-statistic|2.284||||0.022|TWO_SIDED|95.0|0.324|4.244|||ANCOVA|||||4.244|0.324|0.022
70916428|NCT02477670|141323450|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.17||||0.862|TWO_SIDED|95.0|-2.13|1.79|||ANCOVA|||||1.79|-2.13|0.862
70916429|NCT02477670|141323451|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.149||||0.251|TWO_SIDED|95.0|-3.109|0.811|||ANCOVA|||||0.811|-3.109|0.251
70916430|NCT02477670|141323452|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.159||||0.246|TWO_SIDED|95.0|-3.119|0.801|||ANCOVA|||||0.801|-3.119|0.246
70916431|NCT02477670|141323453|SUPERIORITY||SPCD Weighted OLS z-statistic|0.231||||0.818|TWO_SIDED|95.0|-1.729|2.191|||ANCOVA|||||2.191|-1.729|0.818
70916432|NCT02477670|141323454|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.04||||0.968|TWO_SIDED|95.0|-2.0|1.92|||ANCOVA|||||1.92|-2.00|0.968
70916433|NCT02477670|141323455|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.306||||0.76|TWO_SIDED|95.0|-2.266|1.654|||ANCOVA|||||1.654|-2.266|0.760
70916434|NCT02477670|141323456|SUPERIORITY||SPCD Weighted OLS z-statistic|1.243||||0.214|TWO_SIDED|95.0|-0.717|3.203|||ANCOVA|||||3.203|-0.717|0.214
70916435|NCT02477670|141323457|SUPERIORITY|||||||0.071|||||||SPCD 1 degree of freedom score test|||||||0.071
70916436|NCT02477670|141323458|SUPERIORITY||SPCD Weighted OLS z-statistic|0.951||||-0.06|TWO_SIDED|95.0|-1.009|2.911|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||2.911|-1.009|-0.06
70916437|NCT02694978|141323502|NON_INFERIORITY|The non-inferiority margin of 2.64% was used for the primary endpoint statistical analysis.|Treatment difference|-0.1||||0.0001|TWO_SIDED|95.0|-0.8|0.61|||Wald|The p-value was calculated using the Wald large sample assumption.||"Statistical analysis was only performed on composite reaction data (that is, the Any TE moderate to severe hypersensitivity rxn row in the data table)."||0.61|-0.80|0.0001
70916438|NCT02680457|141323591|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.630
70916439|NCT02680457|141323592|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
70916440|NCT01924767|141323612|SUPERIORITY_OR_OTHER||Geometric Mean of ratio|43.661|||||TWO_SIDED|95.0|27.52|69.269|||Regression, Linear|||This was non-confirmatory testing, dose proportionality of dose from 2.5mg to 100mg for Cmax (single dose) was analysed.||69.269|27.520|
70916441|NCT01924767|141323612|SUPERIORITY_OR_OTHER||Geometric Mean of ratio|31.234|||||TWO_SIDED|95.0|12.193|80.011|||Regression, Linear|||This was non-confirmatory testing, dose proportionality of dose from 2.5mg to 100mg for Cmax,ss (Multiple dose) was analysed.||80.011|12.193|
70916442|NCT01924767|141323613|SUPERIORITY_OR_OTHER||Geometric mean of ratio|49.707|||||TWO_SIDED|95.0|33.49|73.776|||Regression, Linear|||This was non-confirmatory testing, dose proportionality of dose from 2.5mg to 100mg for AUC (0-infinity, single dose) was analysed.||73.776|33.490|
70916443|NCT01924767|141323613|SUPERIORITY_OR_OTHER||Geometric mean of ratio|37.632|||||TWO_SIDED|95.0|15.429|91.789|||Regression, Linear|||This was non confirmatory testing, dose proportionality of dose from 2.5mg to 100mg for AUC (0-infinity, at steady state, day 9) was analysed.||91.789|15.429|
70916444|NCT01924767|141323624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37645.43||||0.0067|TWO_SIDED|95.0|11021.57|64269.3||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.||The mean change from baseline (day -2) to day 8 and comparisons to placebo for Urine Glucose Excretion (AE(0-24)).||64269.30|11021.57|0.0067
70916445|NCT01924767|141323624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|82898.2|||<|0.0001|TWO_SIDED|95.0|55344.83|110451.6||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo is calculated.|The mean change from baseline (day -2) to day 8 and comparisons to placebo for Urine Glucose Excretion (AE(0-24)).||110451.6|55344.83|<0.0001
70916446|NCT01924767|141323624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|79982.89|||<|0.0001|TWO_SIDED|95.0|53087.22|106878.6||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean Difference to placebo is calculated.|The mean change from baseline (day -2) to day 8 and comparisons to placebo for Urine Glucose Excretion (AE(0-24)).||106878.6|53087.22|<0.0001
70916447|NCT01924767|141323624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|91306.96|||<|0.0001|TWO_SIDED|95.0|64685.41|117928.5||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean Difference to placebo was calculated|The mean change from baseline (day -2) to day 8 and comparisons to placebo for Urine Glucose Excretion (AE(0-24)).||117928.5|64685.41|<0.0001
70916448|NCT01924767|141323625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.456||||0.0449|TWO_SIDED|95.0|-30.543|-0.369||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent decrease in Mean daily glucose from baseline with treatment compared with placebo from baseline -2 to day 8||-0.369|-30.543|0.0449
70916449|NCT01924767|141323625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.467||||0.0042|TWO_SIDED|95.0|-39.085|-7.848||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent decrease in Mean daily glucose from baseline with treatment compared with placebo from baseline -2 to day 8||-7.848|-39.085|0.0042
70916450|NCT01924767|141323625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.956||||0.0521|TWO_SIDED|95.0|-30.057|0.145||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent decrease in Mean daily glucose from baseline with treatment compared with placebo from baseline -2 to day 8||0.145|-30.057|0.0521
70916451|NCT01924767|141323625|SUPERIORITY_OR_OTHER||Difference to placebo|-10.602||||0.1676|TWO_SIDED|95.0|-25.848|4.644||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated|The mean percent decrease in Mean daily glucose from baseline with treatment compared with placebo from baseline -2 to day 8||4.644|-25.848|0.1676
70916452|NCT01924767|141323626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.269||||0.2239|TWO_SIDED|95.0|-19.162|4.624||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent change in Fasting Plasma Glucose from baseline with treatment compared with placebo from baseline -2 to day 8||4.624|-19.162|0.2239
71093026|NCT00689936|141693002|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.05821|TWO_SIDED|95.0|0.76|1.0||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.|||1.00|0.76|0.05821
70916453|NCT01924767|141323626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.844||||0.0421||95.0|-25.205|-0.484||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated|The mean percent change in Fasting Plasma Glucose from baseline with treatment compared with placebo from baseline -2 to day 8||-0.484|-25.205|0.0421
70916454|NCT01924767|141323626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.719||||0.6527|TWO_SIDED|95.0|-14.842|9.403||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent change in Fasting Plasma Glucose from baseline with treatment compared with placebo from baseline -2 to day 8||9.403|-14.842|0.6527
70916455|NCT01924767|141323626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.998||||0.1318|TWO_SIDED|95.0|-20.818|2.822||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent change in Fasting Plasma Glucose from baseline with treatment compared with placebo from baseline -2 to day 8||2.822|-20.818|0.1318
70916456|NCT01678196|141323629|SUPERIORITY_OR_OTHER|||||||0.927|TWO_SIDED||||||Chi-squared|||||||0.927
70916457|NCT01678196|141323630|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||ANCOVA|ANCOVA reflects change from Time 1 scores (entered as covariate) to Time 2 Scores.||||||0.67
70916458|NCT01678196|141323631|SUPERIORITY_OR_OTHER|||||||0.743|TWO_SIDED||||||ANCOVA|ANCOVA results include Time 1 scores as a covariate, thus reflecting change over time||||||0.743
70916459|NCT01678196|141323632|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|ANCOVA reflects change for Time 1 values (entered as the covariate) to Time 2 values (entered as the DV)||||||<.001
70916460|NCT01256034|141323646|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|||||||<0.05
70916461|NCT03987451|141323663|SUPERIORITY||Odds Ratio (OR)|0.28||||0.0867|TWO_SIDED|95.0|0.06|1.24|||Cochran-Mantel-Haenszel|||The common odds ratio between semaglutide and placebo adjusting for baseline diabetes was estimated along with exact 95% confidence interval based on conditioning on the marginal 2×2 tables.||1.24|0.06|0.0867
70916462|NCT00004124|141323743|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.7|TWO_SIDED|95.0|0.79|1.43|||Regression, Cox|||||1.43|0.79|0.70
70916463|NCT00004124|141323744|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.94|TWO_SIDED|95.0|0.8|1.27|||Regression, Cox|||||1.27|0.80|0.94
70916464|NCT02296424|141323748|EQUIVALENCE|nominal 2.5% two-sided significance level was expected to have 90% powe to detect a difference between the Null Hypothesis proportion of patients who remain at their dose level.||||||0.0001|||||||exact binomial test|||||||0.0001
70916465|NCT04956575|141323755|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.82|||||TWO_SIDED|95.0|1.27|2.61|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||2.61|1.27|
70916466|NCT04956575|141323755|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|2.57|||||TWO_SIDED|95.0|1.79|3.7|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||3.70|1.79|
70916467|NCT04956575|141323755|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|2.7|||||TWO_SIDED|95.0|1.88|3.88|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||3.88|1.88|
70916468|NCT04956575|141323755|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.79|||||TWO_SIDED|95.0|1.29|2.5|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||2.50|1.29|
70916469|NCT04956575|141323755|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|2.19|||||TWO_SIDED|95.0|1.57|3.05|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||3.05|1.57|
70916470|NCT04956575|141323755|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|2.52|||||TWO_SIDED|95.0|1.81|3.5|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||3.50|1.81|
70916471|NCT04956575|141323755|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.68|||||TWO_SIDED|95.0|0.54|0.87|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||0.87|0.54|
70916472|NCT04956575|141323755|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.88|||||TWO_SIDED|95.0|0.69|1.12|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||1.12|0.69|
71093027|NCT00689936|141693003|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.02||||0.93824|TWO_SIDED|95.0|0.75|1.38|||Fisher Exact|||||1.38|0.75|0.93824
70916473|NCT04956575|141323755|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.84|||||TWO_SIDED|95.0|0.66|1.06|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||1.06|0.66|
71093028|NCT00689936|141693003|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.76||||0.08836|TWO_SIDED|95.0|0.56|1.03|||Fisher Exact|||||1.03|0.56|0.08836
71093029|NCT00689936|141693003|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.34||||0.04974|TWO_SIDED|95.0|1.01|1.79|||Fisher Exact|||||1.79|1.01|0.04974
71093030|NCT00689936|141693004|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.68||||0.02134|TWO_SIDED|95.0|1.08|2.59|||Fisher Exact|||||2.59|1.08|0.02134
70916474|NCT04956575|141323755|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.11|||||TWO_SIDED|95.0|0.86|1.44|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||1.44|0.86|
70916475|NCT04956575|141323755|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.19|||||TWO_SIDED|95.0|0.93|1.54|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||1.54|0.93|
70916476|NCT04956575|141323755|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.2|||||TWO_SIDED|95.0|0.93|1.55|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||1.55|0.93|
70916477|NCT04956575|141323756|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.9|||||TWO_SIDED|95.0|0.57|1.44|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||1.44|0.57|
70916478|NCT04956575|141323756|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.25|||||TWO_SIDED|95.0|0.78|2.0|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||2.00|0.78|
70916479|NCT04956575|141323756|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.86|||||TWO_SIDED|95.0|1.16|2.99|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent. against H1N1 at Day 29.||2.99|1.16|
70916480|NCT04956575|141323756|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.41|||||TWO_SIDED|95.0|0.91|2.21|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||2.21|0.91|
70916481|NCT04956575|141323756|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.89|||||TWO_SIDED|95.0|1.21|2.97|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||2.97|1.21|
70916482|NCT04956575|141323756|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|2.64|||||TWO_SIDED|95.0|1.68|4.14|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||4.14|1.68|
70916483|NCT04956575|141323756|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.36|||||TWO_SIDED|95.0|0.26|0.5|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||0.50|0.26|
70916484|NCT04956575|141323756|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.46|||||TWO_SIDED|95.0|0.33|0.64|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||0.64|0.33|
70916485|NCT04956575|141323756|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.54|||||TWO_SIDED|95.0|0.38|0.76|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||0.76|0.38|
70916486|NCT04956575|141323756|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.62|||||TWO_SIDED|95.0|0.43|0.9|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||0.90|0.43|
70916487|NCT04956575|141323756|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.92|||||TWO_SIDED|95.0|0.63|1.35|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||1.35|0.63|
70916488|NCT04956575|141323756|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.75|||||TWO_SIDED|95.0|0.51|1.09|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||1.09|0.51|
70916489|NCT04956575|141323759|OTHER||Percent difference|12.61|||||TWO_SIDED|95.0|-2.0|27.93|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||27.93|-2.00|
70916490|NCT04956575|141323759|OTHER||Percent difference|25.17|||||TWO_SIDED|95.0|11.18|39.89|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||39.89|11.18|
70916491|NCT04956575|141323759|OTHER||Percent Difference|26.2|||||TWO_SIDED|95.0|12.33|40.84|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||40.84|12.33|
70916492|NCT04956575|141323759|OTHER||Percent Difference|25.59|||||TWO_SIDED|95.0|9.82|40.13|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||40.13|9.82|
70916493|NCT04956575|141323759|OTHER||Percent Difference|31.35|||||TWO_SIDED|95.0|15.66|45.73|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||45.73|15.66|
70916494|NCT04956575|141323759|OTHER||Percent Difference|38.34|||||TWO_SIDED|95.0|22.98|52.3|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||52.30|22.98|
70916495|NCT04956575|141323759|OTHER||Percent Difference|-9.78|||||TWO_SIDED|95.0|-24.83|3.79|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||3.79|-24.83|
70916496|NCT04956575|141323759|OTHER||Percent Difference|0.64|||||TWO_SIDED|95.0|-14.91|14.73|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||14.73|-14.91|
70916497|NCT04956575|141323759|OTHER||Percent Difference|4.45|||||TWO_SIDED|95.0|-11.19|18.59|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||18.59|-11.19|
70916498|NCT04956575|141323759|OTHER||Percent Difference|8.97|||||TWO_SIDED|95.0|-6.72|23.09|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||23.09|-6.72|
70916499|NCT04956575|141323759|OTHER||Percent Difference|15.13|||||TWO_SIDED|95.0|-0.74|29.37|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||29.37|-0.74|
70916500|NCT04956575|141323759|OTHER||Percent Difference|19.08|||||TWO_SIDED|95.0|3.22|33.22|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent. against Yamagata-lineage at Day 29.||33.22|3.22|
70916501|NCT04956575|141323760|OTHER||Percent Difference|9.18|||||TWO_SIDED|95.0|-10.62|28.31|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||28.31|-10.62|
70916502|NCT04956575|141323760|OTHER||Percent Difference|18.09|||||TWO_SIDED|95.0|-1.81|36.61|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||36.61|-1.81|
70916503|NCT04956575|141323760|OTHER||Percent Difference|23.91|||||TWO_SIDED|95.0|4.2|41.86|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||41.86|4.20|
70916504|NCT04956575|141323760|OTHER||Percent Difference|1.15|||||TWO_SIDED|95.0|-18.41|20.6|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||20.60|-18.41|
70916505|NCT04956575|141323760|OTHER||Percent Difference|22.21|||||TWO_SIDED|95.0|2.09|40.6|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||40.60|2.09|
70916506|NCT04956575|141323760|OTHER||Percent Difference|36.68|||||TWO_SIDED|95.0|17.38|53.36|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||53.36|17.38|
70916507|NCT04956575|141323760|OTHER||Percent Difference|-37.71|||||TWO_SIDED|95.0|-53.36|-20.45|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||-20.45|-53.36|
70916508|NCT04956575|141323760|OTHER||Treatment Difference|-26.18|||||TWO_SIDED|95.0|-43.66|-6.9|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||-6.90|-43.66|
70916509|NCT04956575|141323760|OTHER||Percent Difference|-19.66|||||TWO_SIDED|95.0|-37.95|0.11|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||0.11|-37.95|
70916510|NCT04956575|141323760|OTHER||Percent Difference|-23.43|||||TWO_SIDED|95.0|-41.09|-4.26|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||-4.26|-41.09|
70916511|NCT04956575|141323760|OTHER||Percent Difference|-4.44|||||TWO_SIDED|95.0|-24.09|15.59|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of against Afluria Quadrivalent Yamagata-lineage at Day 29.||15.59|-24.09|
70916512|NCT04956575|141323760|OTHER||Percent Difference|-8.79|||||TWO_SIDED|95.0|-28.13|11.27|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||11.27|-28.13|
70916513|NCT03593876|141323766|OTHER||||||||||||||||||The a priori analysis plan was to defer statistical or hypothesis testing due to the focus on feasibility, and rather to assess mean participant-therapist communication scores across intervention sessions. The mean and standard deviation of these scores was 3.00 (1.00). The a priori criterion for feasibility was a mean score of 2.0 or greater.|||
70916514|NCT03593876|141323767|OTHER||Mean Difference (Net)|51.71|STANDARD_DEVIATION|21.04|||TWO_SIDED|||||||||The a priori analysis plan was to defer statistical or hypothesis testing due to the focus on feasibility, and rather to assess change scores and effect size of the change scores to compare with previously published clinical trials.|The repeated measures effect size of change was Cohen's d(rm)=3.08.|||
70916515|NCT03593876|141323768|OTHER||Mean Difference (Net)|11.02|STANDARD_DEVIATION|7.24|||TWO_SIDED|||||||||The a priori analysis plan was to defer statistical or hypothesis testing due to the focus on feasibility, and rather to assess change scores and effect size of the change scores to compare with previously published clinical trials.|The repeated measures effect size of change, Cohen's d(rm)=1.70|||
70916516|NCT00432458|141323776|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Log Rank|Model was stratified by beta-2 microglobulin (high vs low), lytic bone lesions (present vs not) and bone marrow labeling index (high vs low)||||||0.02
70916517|NCT00432458|141323777|SUPERIORITY_OR_OTHER|||||||0.0048||95.0|||||Chi-squared|||||||0.0048
70916518|NCT00432458|141323778|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
70916519|NCT03823300|141323783|NON_INFERIORITY|If the lower bound of a two-sided 95.03% confidence interval (CI) for the difference in adjusted means of the two treatments (faricimab minus aflibercept) is greater than -4 letters (the non-inferiority margin), then faricimab is considered non-inferior to aflibercept.|Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|-1.7|1.8|||||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|The null hypothesis, H0: μ(faricimab) - μ(aflibercept) ≤-4 letters; the alternative hypothesis, Ha: μ(faricimab) - μ(aflibercept) \>-4 letters. A sample size of approximately 320 participants in each arm provided greater than 90% power to show non-inferiority of faricimab to aflibercept in the change from baseline BCVA averaged over Weeks 40, 44, and 48 in the ITT population, using a non-inferiority margin of 4 letters at the one-sided 0.02485 significance level.||1.8|-1.7|
70916520|NCT03823300|141323784|OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.93|||TWO_SIDED|95.0|-2.4|1.3|||||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|Treatment Difference in Adjusted Means at Weeks 52-60||1.3|-2.4|
70916521|NCT03823300|141323786|OTHER||Difference in CMH Weighted Percentage|-2.0|||||TWO_SIDED|95.0|-8.3|4.3|||||The treatment difference in CMH weighted percentage of participants gaining ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥15 Letters: Treatment Difference at Weeks 40-48||4.3|-8.3|
70916522|NCT03823300|141323786|OTHER||Difference in CMH Weighted Percentage|3.4|||||TWO_SIDED|95.0|-3.9|10.7|||||The treatment difference in CMH weighted percentage of participants gaining ≥10 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥10 Letters: Treatment Difference at Weeks 40-48||10.7|-3.9|
70916523|NCT03823300|141323786|OTHER||Difference in CMH Weighted Percentage|1.0|||||TWO_SIDED|95.0|-6.6|8.6|||||The treatment difference in CMH weighted percentage of participants gaining ≥5 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥5 Letters: Treatment Difference at Weeks 40-48||8.6|-6.6|
70916524|NCT03823300|141323786|OTHER||Difference in CMH Weighted Percentage|3.1|||||TWO_SIDED|95.0|-3.1|9.3|||||The treatment difference in CMH weighted percentage of participants gaining ≥0 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥0 Letters: Treatment Difference at Weeks 40-48||9.3|-3.1|
70916525|NCT03823300|141323787|OTHER||Difference in CMH Weighted Percentage|-1.2|||||TWO_SIDED|95.0|-7.7|5.3|||||The treatment difference in CMH weighted percentage of participants gaining ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 52-60||5.3|-7.7|
70916526|NCT03823300|141323792|OTHER||Difference in CMH Weighted Percentage|-1.5|||||TWO_SIDED|95.0|-4.4|1.3|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Avoiding a Loss of ≥15 Letters: Treatment Difference at Weeks 40-48||1.3|-4.4|
70916527|NCT03823300|141323792|OTHER||Difference in CMH Weighted Percentage|-0.9|||||TWO_SIDED|95.0|-4.5|2.8|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥10 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Avoiding a Loss of ≥10 Letters: Treatment Difference at Weeks 40-48||2.8|-4.5|
70916528|NCT03823300|141323792|OTHER||Difference in CMH Weighted Percentage|2.6|||||TWO_SIDED|95.0|-2.1|7.3|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥5 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Avoiding a Loss of ≥5 Letters: Treatment Difference at Weeks 40-48||7.3|-2.1|
70916529|NCT03823300|141323793|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-2.6|3.3|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 52-60||3.3|-2.6|
70916530|NCT03823300|141323797|OTHER||Difference in CMH Weighted Percentage|-1.7|||||TWO_SIDED|95.0|-8.5|5.1|||||The treatment difference in CMH weighted percentage of participants gaining ≥15 letters or achieving BCVA ≥84 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 40-48||5.1|-8.5|
70916531|NCT03823300|141323799|OTHER||Difference in CMH Weighted Percentage|5.7|||||TWO_SIDED|95.0|-1.4|12.9|||||The treatment difference in CMH weighted percentage of participants achieving BCVA ≥69 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 40-48||12.9|-1.4|
70916532|NCT03823300|141323801|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-3.6|4.4|||||The treatment difference in CMH weighted percentage of participants with BCVA ≤38 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 40-48||4.4|-3.6|
70916533|NCT03823300|141323809|OTHER||Adjusted mean difference|-6.4|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-14.8|2.1|||||The treatment difference in adjusted means of change from baseline CST is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|Treatment Difference in Adjusted Means at Weeks 40-48||2.1|-14.8|
70916534|NCT03823300|141323810|OTHER||Adjusted mean difference|1.4|STANDARD_ERROR_OF_MEAN|4.05|||TWO_SIDED|95.0|-6.6|9.3|||||The treatment difference in adjusted means of change from baseline CST is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|Treatment Difference in Adjusted Means at Weeks 52-60||9.3|-6.6|
70916535|NCT01786564|141323836|OTHER|This is cross-sectional analysis in a single group.|Regression Coefficient|-0.075||||0.13|TWO_SIDED|95.0|-0.173|0.023||Unadjusted association. A priori p value of .05 was selected for statistical significance.|Regression, Linear|||The cross-sectional association between habitual sleep duration and oral disposition index was analyzed.||.023|-.173|.13
70916536|NCT01786564|141323836|OTHER|This is cross-sectional analysis|Regression Coefficient|0.12||||0.83|TWO_SIDED|95.0|-0.95|1.19||Unadjusted association. P value of .05 was selected a priori as statistical significance|Regression, Linear|Unadjusted.||The cross-sectional association between habitual sleep quality (sleep percentage) and oral disposition index was analyzed.||1.19|-0.95|.83
70916537|NCT01786564|141323836|OTHER|This is cross-sectional analysis in a single group.|Regression Coefficient|-0.05||||0.39|TWO_SIDED|95.0|-0.166|0.66||Unadjusted association. A priori p value of .05 was selected for statistical significance.|Regression, Linear|Unadjusted||The cross-sectional association between amount of Stage 3 sleep and oral disposition index was analyzed.||0.66|-.166|.39
70916538|NCT01786564|141323836|OTHER|Unadjusted association. P value of .05 was selected a priori as statistical significance|Regression Coefficient|-0.058||||0.11|TWO_SIDED|95.0|-0.129|0.014||Unadjusted association. P value of .05 was selected a priori as statistical significance|Regression, Linear|Unadjusted association.||The cross-sectional association between amount of REM sleep and oral disposition index was analyzed.||.014|-.129|.11
70916539|NCT01290224|141323838|NON_INFERIORITY_OR_EQUIVALENCE|A one-sided McNemar's test of the primary endpoint with 10 patients will have 86% power at 5% Type I error rate to detect a 60% difference in the percentage of at least 50% reduction in the scrambler and sham procedure, based on the assumption that the proportion of discordant pairs is at 70%.||||||0.763||95.0|||||McNemar|||McNemar's test was used to test for a difference between Scrambler and Sham procedure in their success rate.||||0.7630
70916540|NCT00346333|141323845|SUPERIORITY_OR_OTHER|||||||0.66||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Longitudinal regression analysis|||"Primary Analysis:Proc mixed of the Statistical Analysis System (SAS) was used to compare annual rates of change by treatment group over 4 years.~Power Calculation:240 patients were estimated to be needed to provide sufficient power (i.e. alpha=0.05;beta=0.10)to observe a statistically significant difference between mean change in the 2 groups on the HFA 30-2 total point score over a 4-year interval."||||0.66
70916541|NCT00346333|141323845|SUPERIORITY_OR_OTHER|||||||0.52||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Clustered Wilcoxon|||Secondary Analysis: As change distribution was non-normal, slope for each eye was calculated with least squares regression and converted to ranks. The Clustered Wilcoxon test was used to compare slope distributions between groups accounting for correlation between slopes for eyes within individuals.||||0.52
70916542|NCT00346333|141323846|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Longitudinal regression analysis|||Primary Analysis: Proc Mixed of SAS was used to compare annual rates of change by treatment group over four years.The unit of analysis was the eye. Each patient contributed 2, 1, or 0 eyes with non-missing data.||||0.05
70916543|NCT00346333|141323846|SUPERIORITY_OR_OTHER|||||||0.03||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Clustered Wilcoxon|||Secondary Analysis: As change distribution was non-normal, slope for each eye was calculated with least squares regression and converted to ranks. The Clustered Wilcoxon test was used to compare slope distributions between groups accounting for correlation between slopes for eyes within individuals.||||0.03
70916544|NCT00346333|141323847|SUPERIORITY_OR_OTHER|||||||0.24||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Longitudinal regression analysis|||Primary analysis:Proc Mixed of SAS was used to compare annual rates of change by treatment group over four years.The unit of analysis was the eye.Each patient contributed 2,1,or 0 eyes with non-missing data.||||0.24
70916545|NCT00346333|141323847|SUPERIORITY_OR_OTHER|||||||0.2||||||Apriori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Clustered Wilcoxon|||Secondary Analysis: As change distribution was non-normal, slope for each eye was calculated with least squares regression and converted to ranks. The Clustered Wilcoxon test was used to compare slope distributions between groups accounting for correlation between slopes for eyes within individuals.||||0.20
70916546|NCT00346333|141323848|SUPERIORITY_OR_OTHER|||||||0.59||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Longitudinal regression analysis|||Proc MIXED of SAS was used to compare annual rates of change over four years between the treatment groups.||||0.59
70916547|NCT00346333|141323849|SUPERIORITY_OR_OTHER|||||||0.8||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Longitudinal regression analysis|||Proc MIXED of SAS was used to compare annual rates of change over 4 years between the 2 groups.||||0.80
71093031|NCT00689936|141693004|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01||||1|TWO_SIDED|95.0|0.64|1.59|||Fisher Exact|||||1.59|0.64|1.00000
71093032|NCT00689936|141693004|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.65||||0.02374|TWO_SIDED|95.0|1.08|2.53|||Fisher Exact|||||2.53|1.08|0.02374
71093033|NCT00689936|141693005|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.7||||0.11152|TWO_SIDED|95.0|0.91|3.21|||Fisher Exact|||||3.21|0.91|0.11152
71093034|NCT00689936|141693005|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.93||||0.86336|TWO_SIDED|95.0|0.47|1.83|||Fisher Exact|||||1.83|0.47|0.86336
71093035|NCT00689936|141693005|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.84||||0.07321|TWO_SIDED|95.0|0.96|3.55|||Fisher Exact|||||3.55|0.96|0.07321
70916548|NCT00723450|141323850|SUPERIORITY_OR_OTHER|||||||0.0717||95.0|||||Log Rank|A stratified log rank test was performed where the stratification factor was the index mood state at Screen visit.||||||0.0717
70916549|NCT00612586|141323890|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8956||||||One sided|Log Rank|||||||0.8956
70916550|NCT00612586|141323891|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9865||||||One-sided|Log Rank|||||||0.9865
70916551|NCT01194154|141323900|SUPERIORITY_OR_OTHER||treatment effect|2.21||||0.657|TWO_SIDED|95.0|-0.35|4.78|||Wilcoxon (Mann-Whitney)||An analysis of covariance (ANCOVA) model with adjustment for baseline eGFR was used to obtain an estimate of the treatment difference.|||4.78|-0.35|0.657
70916552|NCT01194154|141323901|SUPERIORITY_OR_OTHER||treatment effect|2.24||||0.709|TWO_SIDED|95.0|-0.54|5.01|||Wilcoxon (Mann-Whitney)||ANCOVA model with adjustment for baseline eGFR was used to obtain an estimate of the treatment difference.|||5.01|-0.54|0.709
70916553|NCT02314117|141323934|SUPERIORITY||Hazard Ratio (HR)|0.753|||||TWO_SIDED|95.0|0.607|0.935||||||||0.935|0.607|
70916554|NCT02314117|141323935|SUPERIORITY||Hazard Ratio (HR)|0.962|||||TWO_SIDED|95.0|0.801|1.156||||||||1.156|0.801|
70916555|NCT02314117|141323936|SUPERIORITY||Hazard Ratio (HR)|0.926|||||TWO_SIDED|95.0|0.774|1.108||||||||1.108|0.774|
70916556|NCT02314117|141323939|SUPERIORITY||Hazard Ratio (HR)|0.699|||||TWO_SIDED|95.0|0.569|0.859||||||||0.859|0.569|
70916557|NCT02314117|141323940|SUPERIORITY||Hazard Ratio (HR)|0.657|||||TWO_SIDED|95.0|0.499|0.866||||||||0.866|0.499|
70916558|NCT02314117|141323941|SUPERIORITY||Hazard Ratio (HR)|1.013|||||TWO_SIDED|95.0|0.77|1.332||||||||1.332|0.770|
70916559|NCT02314117|141323943|SUPERIORITY||Hazard Ratio (HR)|1.117|||||TWO_SIDED|95.0|0.79|1.58||||||||1.580|0.790|
70916560|NCT02026258|141323947|OTHER||Mean Difference (Final Values)|0.52|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Based on previous findings, it takes approximately 117 ± 46 days for complete alignment of the mandibular anterior teeth in subjects with severe crowding treated without extractions. For a clinically significant 40% faster alignment in the piezotome-corticision group compared to the control group at an alpha-level (p = 0.05) and desired power of 80%, a sample size of 28 subjects (14 per group) was required. Twenty subjects per group assuming an overall attrition rate of 28%.||||<0.05
70916561|NCT02026258|141323948|OTHER||Mean Difference (Final Values)|0.3|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VAS T0||||<0.05
71093036|NCT00689936|141693006|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.62||||0.00043|TWO_SIDED|95.0|1.55|4.45|||Fisher Exact|||||4.45|1.55|0.00043
70916562|NCT02026258|141323948|OTHER||Mean Difference (Final Values)|0.19|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VAS T1||||<0.05
70916563|NCT02026258|141323948|OTHER||Mean Difference (Final Values)|0.19|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VAS T2||||<0.05
70916564|NCT02026258|141323948|OTHER||Mean Difference (Final Values)|0.76|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VAS T3||||<0.05
70916565|NCT02026258|141323949|OTHER||Mean Difference (Final Values)|0.87|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Ease of Procedure||||<0.05
70916566|NCT02026258|141323949|OTHER||Mean Difference (Final Values)|0.69|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Satisfaction with procedure||||<0.05
70916567|NCT02026258|141323950|OTHER||Fisher chi square|0.71|||<|0.05|TWO_SIDED||||||Fisher Exact|Use of Medications||||||<0.05
70916568|NCT02026258|141323950|OTHER||Fisher chi square|0.99|||<|0.05|TWO_SIDED||||||Fisher Exact|||Undergo procedure again||||<0.05
70916569|NCT02026258|141323950|OTHER||Fisher chi square|0.49|||<|0.05|TWO_SIDED||||||Fisher Exact|||Recommend procedure to a friend||||<0.05
70916570|NCT05565391|141323956|OTHER||Risk Ratio (RR)|1.95|||<|0.0001|TWO_SIDED|95.0|1.54|2.47|||Log-binomial regression model||Unweighted RRs were estimated using a log-binomial regression model with Wald confidence intervals.|||2.47|1.54|<.0001
70916571|NCT05565391|141323956|OTHER||Risk Ratio (RR)|2.01|||<|0.0001|TWO_SIDED|95.0|1.52|2.67|||Log-binomial regression model||Unweighted RRs were estimated using a log-binomial regression model with Wald confidence intervals.|||2.67|1.52|<.0001
70916572|NCT05565391|141323957|OTHER||Risk Ratio (RR)|2.22|||<|0.0001|TWO_SIDED|95.0|1.69|2.9|||Log-binomial regression model||Risk ratio was estimated using a log-binomial regression model and confidence interval was estimated using robust error variance.|||2.90|1.69|<.0001
70916573|NCT05565391|141323958|OTHER||Risk Ratio (RR)|1.79||||0.0447|TWO_SIDED|95.0|1.01|3.15|||Log-binomial regression model||Risk ratio was estimated using a log-binomial regression model and confidence interval was estimated using robust error variance.|||3.15|1.01|0.0447
70916574|NCT05565391|141323959|OTHER|||||||0.4241|||||||Quantile regression|||||||0.4241
70916575|NCT05565391|141323959|OTHER|||||||0.0281|||||||Quantile regression|||||||0.0281
70916576|NCT05565391|141323960|OTHER|||||||0.7682|||||||Quantile regression|||||||0.7682
70916577|NCT05565391|141323961|OTHER|||||||0.0326|||||||Quantile regression|||||||0.0326
70916578|NCT05565391|141323962|OTHER||Hazard Ratio (HR)|0.17|||<|0.0001|TWO_SIDED|95.0|0.09|0.31|||Cox proportional hazard model||Hazard ratio was estimated using unadjusted Cox proportional hazard model.|||0.31|0.09|<.0001
70916579|NCT05565391|141323962|OTHER||Hazard Ratio (HR)|0.22|||<|0.0001|TWO_SIDED|95.0|0.11|0.43|||Cox proportional hazard model||Hazard ratio was estimated using unadjusted Cox proportional hazard model.|||0.43|0.11|<.0001
70916580|NCT05565391|141323963|OTHER||Hazard Ratio (HR)|0.11|||<|0.0001|TWO_SIDED|95.0|0.06|0.22|||Cox proportional hazard model||Hazard ratio was estimated using weighted Cox proportional hazard model and confidence interval was estimated using robust error variance.|||0.22|0.06|<.0001
70916581|NCT05565391|141323964|OTHER||Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.1|0.45|||Weighted Cox proportional hazard model||Hazard ratio was estimated using weighted Cox proportional hazard model and confidence interval was estimated using robust error variance.|||0.45|0.10|<.0001
70916582|NCT02716324|141323965|SUPERIORITY||Beta Coefficient|0.001||||0.871|TWO_SIDED|95.0|-0.01|0.012|||GLS random-effects model|||Random effects models regressed VPRS scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. We examined intervention X time interaction term for statistical significance.||0.012|-0.010|.871
71093037|NCT00689936|141693006|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.38||||0.31274|TWO_SIDED|95.0|0.78|2.43|||Fisher Exact|||||2.43|0.78|0.31274
71093038|NCT00689936|141693006|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.01936|TWO_SIDED|95.0|1.13|3.19|||Fisher Exact|||||3.19|1.13|0.01936
71093039|NCT00689936|141693007|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.13||||0.82128|TWO_SIDED|95.0|0.46|2.8|||Fisher Exact|||||2.80|0.46|0.82128
70916583|NCT02716324|141323966|SUPERIORITY||Beta coefficient|0.001||||0.499|TWO_SIDED|95.0|-0.002|0.004|||Random effects model|||Random effects models regressed GAS scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. We examined intervention X time interaction term for statistical significance.||0.004|-0.002|0.499
70916584|NCT02716324|141323967|SUPERIORITY|||||||0.718|||||||Chi-squared|||Differences in proportions between the two groups in use of any services were assessed using the Chi-square Test.||||0.718
70916585|NCT02716324|141323967|SUPERIORITY|||||||0.903|||||||Chi-squared|||Differences in proportions between the two groups in use of ambulatory mental health services were assessed using the Chi-square Test.||||0.903
70916586|NCT02716324|141323967|SUPERIORITY|||||||0.915|||||||Chi-squared|||Differences in proportions between the two groups in use of any inpatient mental health services were assessed using the Chi-square Test.||||0.915
70916587|NCT02716324|141323968|SUPERIORITY|||||||0.31|||||||Chi-squared|||Differences in proportions between the two groups in use of any mental health services during the study period were assessed using the Chi-square Test.||||0.310
70916588|NCT02716324|141323968|SUPERIORITY|||||||0.251|||||||Chi-squared|||Differences in proportions between the two groups in use of ambulatory mental health services during the study period were assessed using the Chi-square Test.||||0.251
70916589|NCT02716324|141323968|SUPERIORITY|||||||1|||||||Chi-squared|||Differences in proportions between the two groups in use of inpatient mental health services during the study period were assessed using the Chi-square Test.||||1.00
70916590|NCT02716324|141323969|SUPERIORITY||Beta coefficient|0.0||||0.662|TWO_SIDED|95.0|-0.001|0.001|||Random effects model|||Random effects models regressed Parent-reported PRO School Performance Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.662
70916591|NCT02716324|141323969|SUPERIORITY||Beta coefficient|0.001||||0.075|TWO_SIDED|95.0|0.0|0.002|||Random effects model|||Random effects models regressed Child PRO School Performance Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.002|0.000|0.075
70916592|NCT02716324|141323970|SUPERIORITY||Beta coefficient|0.0||||0.707|TWO_SIDED|95.0|-0.001|0.001|||Random effects model|||Random effects models regressed Parent-reported PRO Student Engagement Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.707
70916593|NCT02716324|141323970|SUPERIORITY||Beta coefficient|0.0||||0.735|TWO_SIDED|95.0|-0.001|0.001|||Random effects model|||Random effects models regressed Child PRO Student Engagement Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.735
70916594|NCT02716324|141323971|SUPERIORITY||Beta coefficient|0.0||||0.735|TWO_SIDED|95.0|-0.001|0.001||Random effects models regressed Child Patient Reported Outcomes Teacher Connectedness Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. The threshold for statistical significance was p\<0.05.|Random effects model|||Random effects models regressed Child PRO Teacher Connectedness Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.735
70916595|NCT02716324|141323972|SUPERIORITY||Beta coefficient|0.0||||0.873|TWO_SIDED|95.0|-0.001|0.001||Random effects models regressed Parent Patient Reported Outcomes Peer Relationships Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. The threshold for statistical significance was p\<0.05.|Random effects model|||Random effects models regressed Parent-reported PRO Peer Relationship Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.873
70916596|NCT02716324|141323972|SUPERIORITY||Beta coefficient|0.0||||0.888|TWO_SIDED|95.0|-0.001|0.001||Random effects models regressed Child Patient Reported Outcomes Peer Relationships Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. The threshold for statistical significance was p\<0.05.|Random effects model|||Random effects models regressed Child-reported PRO Peer Relationship Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.888
70916597|NCT02716324|141323973|SUPERIORITY||Beta coefficient|0.0||||0.679|TWO_SIDED|95.0|-0.001|0.001||Random effects models regressed Child Patient Reported Outcomes Family Relationships Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. The threshold for statistical significance was p\<0.05.|Random effects model|||Random effects models regressed Child-reported PRO Family Relationship Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.679
70916598|NCT02716324|141323974|SUPERIORITY||Beta coefficient|0.074||||0.495|TWO_SIDED|95.0|-0.164|0.311|||Random effects model|||Random effects models regressed Access Engagement Scores Scores on intervention status adjusted for season and clustered by doctor's office.||0.311|-0.164|0.495
71093040|NCT00689936|141693007|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.46||||0.11041|TWO_SIDED|95.0|0.19|1.14|||Fisher Exact|||||1.14|0.19|0.11041
71093041|NCT00689936|141693007|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.44||||0.07302|TWO_SIDED|95.0|1.01|5.91|||Fisher Exact|||||5.91|1.01|0.07302
71093042|NCT01532089|141693035|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.39|TWO_SIDED|95.0|0.5|1.31|||Log Rank|Comparisons of PFS between arms were conducted using a stratified log-rank test.||||1.31|0.50|0.39
71093043|NCT01532089|141693036|SUPERIORITY||Hazard Ratio (HR)|1.41||||0.33|TWO_SIDED|95.0|0.71|2.81|||Log Rank|||||2.81|0.71|0.33
71093044|NCT01532089|141693037|SUPERIORITY|||||||0.81|||||||Chi-squared|||||||0.81
71093045|NCT01995201|141693050|OTHER|||||||0.5231|||||||Chi-squared|||||||0.5231
71093046|NCT00622518|141693093|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|95.0||||P value is based on rating\*group interaction term|linear mixed model|||||||.002
71093047|NCT06001866|141693231|SUPERIORITY||||||<|0.0001|||||||LSD test|||||||<0.0001
70916599|NCT02716324|141323974|SUPERIORITY||Beta coefficient|-0.013||||0.885|TWO_SIDED|95.0|-0.217|0.191|||Random effects model|||Random effects models regressed Patient Family Centered Care Engagement Scores Scores on intervention status adjusted for season and clustered by doctor's office.||0.191|-0.217|0.885
70916600|NCT02716324|141323974|SUPERIORITY||Beta coefficient|0.073||||0.527|TWO_SIDED|95.0|-0.182|0.328|||Random effects model|||Random effects models regressed Communication Engagement Scores Scores on intervention status adjusted for season and clustered by doctor's office.||0.328|-0.182|0.527
70916601|NCT02716324|141323974|SUPERIORITY||Beta coefficient|0.136||||0.285|TWO_SIDED|95.0|-0.138|0.41|||Random effects model|||Random effects models regressed Understanding Engagement Scores Scores on intervention status adjusted for season and clustered by doctor's office.||0.410|-0.138|0.285
70916602|NCT00530842|141323975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.087|STANDARD_ERROR_OF_MEAN|0.044||0.0482|TWO_SIDED|95.0|-0.174|-0.001|||ANOVA|ANOVA with fixed terms for sequence, treatment, and period and random term for subject within sequence.||||-0.001|-0.174|0.0482
70916603|NCT00530842|141323976|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.0||||0.3407|TWO_SIDED|95.0|-9.5|27.5|||Wilcoxon signed-rank test||The confidence interval was determined by Hodges-Lehmann method.|||27.5|-9.5|0.3407
70916604|NCT02534350|141324034|SUPERIORITY||Treatment Difference|0.1||||0.72|TWO_SIDED|95.0|-0.43|0.63|||ANCOVA|||||0.63|-0.43|0.72
70916605|NCT02534350|141324035|SUPERIORITY||Treatment Difference|-0.12||||0.76|TWO_SIDED|95.0|-0.94|0.69|||ANCOVA|||||0.69|-0.94|0.76
70916606|NCT02534350|141324036|SUPERIORITY||Treatment Difference|0.01||||0.86|TWO_SIDED|95.0|-0.12|0.15|||ANCOVA|||||0.15|-0.12|0.86
70916607|NCT02534350|141324037|SUPERIORITY||Treatment Difference|-3.25||||0.6|TWO_SIDED|95.0|-15.58|9.08|||ANCOVA|||||9.08|-15.58|0.60
70916608|NCT04673851|141324038|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|-0.86|STANDARD_DEVIATION|5.44|||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
70916609|NCT04673851|141324038|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.16|||||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
70916610|NCT04673851|141324038|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-2.65|STANDARD_DEVIATION|5.61|||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
70916611|NCT04673851|141324038|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.47|||||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
70916612|NCT04673851|141324038|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|-1.97|STANDARD_DEVIATION|7.19|||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
70916613|NCT04673851|141324038|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.27|||||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
70916614|NCT04673851|141324038|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-4.15|STANDARD_DEVIATION|7.93|||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
70916615|NCT04673851|141324038|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.52|||||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
70916616|NCT04673851|141324039|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|-1.52|STANDARD_DEVIATION|8.95|||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
70916617|NCT04673851|141324039|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.17|||||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
70916618|NCT04673851|141324039|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|1.15|STANDARD_DEVIATION|5.8|||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
70916619|NCT04673851|141324039|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.2|||||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
70916620|NCT04673851|141324039|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|0.67|STANDARD_DEVIATION|10.29|||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
70916621|NCT04673851|141324039|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.07|||||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
70916622|NCT04673851|141324039|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|2.07|STANDARD_DEVIATION|9.47|||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
70916623|NCT04673851|141324039|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.22|||||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
70916624|NCT04673851|141324040|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|-0.05|STANDARD_DEVIATION|7.08|||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
70916625|NCT04673851|141324040|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.01|||||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
70916626|NCT04673851|141324040|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-2.35|STANDARD_DEVIATION|7.53|||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
70916627|NCT04673851|141324040|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.31|||||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
70916628|NCT04673851|141324040|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|0.9|STANDARD_DEVIATION|9.95|||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
71093048|NCT06001866|141693231|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
70916629|NCT04673851|141324040|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.09|||||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
70916630|NCT04673851|141324040|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-2.56|STANDARD_DEVIATION|9.6|||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
70916631|NCT04673851|141324040|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.27|||||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
70916632|NCT04673851|141324041|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|-0.29|STANDARD_DEVIATION|8.27|||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
70916633|NCT04673851|141324041|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.04|||||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
70916634|NCT04673851|141324041|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|2.6|STANDARD_DEVIATION|7.86|||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
70916635|NCT04673851|141324041|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.33|||||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
70916636|NCT04673851|141324041|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|2.17|STANDARD_DEVIATION|7.84|||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
70916637|NCT04673851|141324041|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.28|||||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
70916638|NCT04673851|141324041|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|6.48|STANDARD_DEVIATION|8.5|||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
70916639|NCT04673851|141324041|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.76|||||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
70916640|NCT04673851|141324042|OTHER|Single group mean difference between mid-treatment and post-treatment assessments.|Mean Difference (Net)|4.11|STANDARD_DEVIATION|6.86|||TWO_SIDED|||||||||Posttreatment - Midtreatment: 19 participants analyzed (had data at both timepoints)||||
70916641|NCT04673851|141324042|OTHER|Effect size of single group mean difference between mid-treatment and post-treatment assessments.|Cohen's d|0.6|||||TWO_SIDED|||||||||Posttreatment - Midtreatment: 19 participants analyzed (had data at both timepoints)||||
70916642|NCT04673851|141324042|OTHER|Single group mean difference between 1.5 month and mid-treatment assessments.|Mean Difference (Net)|0.77|STANDARD_DEVIATION|6.88|||TWO_SIDED|||||||||Midtreatment - 1.5 Months: 30 participants analyzed (had data at both timepoints)||||
70916643|NCT04673851|141324042|OTHER|Effect size of single group mean difference between 1.5 month and mid-treatment assessments.|Cohen's d|0.11|||||TWO_SIDED|||||||||Midtreatment - 1.5 Months: 30 participants analyzed (had data at both timepoints)||||
70916644|NCT04673851|141324042|OTHER|Single group mean difference between 1.5 month and 4.5 month assessments.|Mean Difference (Net)|-0.15|STANDARD_DEVIATION|5.78|||TWO_SIDED|||||||||4.5 Months - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
70916645|NCT04673851|141324042|OTHER|Effect size of single group mean difference between 1.5 month and 4.5 month assessments.|Cohen's d|0.03|||||TWO_SIDED|||||||||4.5 Months - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
70916646|NCT04673851|141324042|OTHER|Single group mean difference between 1.5 month and post-treatment assessments.|Mean Difference (Net)|-2.63|STANDARD_DEVIATION|7.95|||TWO_SIDED|||||||||Posttreatment - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
70916647|NCT04673851|141324042|OTHER|Effect size of single group mean difference between 1.5 month and post-treatment assessments.|Cohen's d|0.33|||||TWO_SIDED|||||||||Posttreatment - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
70916648|NCT04673851|141324043|OTHER|Single group mean difference between mid-treatment and post-treatment assessments.|Mean Difference (Net)|1.68|STANDARD_DEVIATION|3.76|||TWO_SIDED|||||||||Posttreatment - Midtreatment: 19 participants analyzed (had data at both timepoints)||||
70916649|NCT04673851|141324043|OTHER|Effect size of single group mean difference between mid-treatment and post-treatment assessments.|Cohen's d|0.45|||||TWO_SIDED|||||||||Posttreatment - Midtreatment: 19 participants analyzed (had data at both timepoints)||||
70916650|NCT04673851|141324043|OTHER|Single group mean difference between 1.5 month and mid-treatment assessments.|Mean Difference (Net)|-0.07|STANDARD_DEVIATION|2.73|||TWO_SIDED|||||||||Midtreatment - 1.5 Months: 30 participants analyzed (had data at both timepoints)||||
70916651|NCT04673851|141324043|OTHER|Effect size of single group mean difference between 1.5 month and mid-treatment assessments.|Cohen's d|0.02|||||TWO_SIDED|||||||||Midtreatment - 1.5 Months: 30 participants analyzed (had data at both timepoints)||||
70916652|NCT04673851|141324043|OTHER|Single group mean difference between 1.5 month and 4.5 month assessments.|Mean Difference (Net)|-0.56|STANDARD_DEVIATION|2.44|||TWO_SIDED|||||||||4.5 Months - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
70916653|NCT04673851|141324043|OTHER|Effect size of single group mean difference between 1.5 month and 4.5 month assessments.|Cohen's d|0.23|||||TWO_SIDED|||||||||4.5 Months - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
70916654|NCT04673851|141324043|OTHER|Single group mean difference between 1.5 month and post-treatment assessments.|Mean Difference (Net)|-0.59|STANDARD_DEVIATION|3.15|||TWO_SIDED|||||||||Posttreatment - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
70916655|NCT04673851|141324043|OTHER|Effect size of single group mean difference between 1.5 month and post-treatment assessments.|Cohen's d|0.19|||||TWO_SIDED|||||||||Posttreatment - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
70916656|NCT04673851|141324044|OTHER|Single group mean difference between mid-treatment and post-treatment assessments.|Mean Difference (Net)|2.42|STANDARD_DEVIATION|4.48|||TWO_SIDED|||||||||Posttreatment - Midtreatment: 19 participants analyzed (had data at both timepoints)||||
70916657|NCT04673851|141324044|OTHER|Effect size of single group mean difference between mid-treatment and post-treatment assessments.|Cohen's d|0.54|||||TWO_SIDED|||||||||Posttreatment - Midtreatment: 19 participants analyzed (had data at both timepoints)||||
71093049|NCT06001866|141693232|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
70916658|NCT04673851|141324044|OTHER|Single group mean difference between 1.5 month and mid-treatment assessments.|Mean Difference (Net)|0.83|STANDARD_DEVIATION|5.05|||TWO_SIDED|||||||||Midtreatment - 1.5 Months: 30 participants analyzed (had data at both timepoints)||||
70916659|NCT04673851|141324044|OTHER|Effect size of single group mean difference between 1.5 month and mid-treatment assessments.|Cohen's d|0.17|||||TWO_SIDED|||||||||Midtreatment - 1.5 Months: 30 participants analyzed (had data at both timepoints)||||
70916660|NCT04673851|141324044|OTHER|Single group mean difference between 1.5 month and 4.5 month assessments.|Mean Difference (Net)|0.41|STANDARD_DEVIATION|4.55|||TWO_SIDED|||||||||4.5 Months - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
70916661|NCT04673851|141324044|OTHER|Effect size of single group mean difference between 1.5 month and 4.5 month assessments.|Cohen's d|0.09|||||TWO_SIDED|||||||||4.5 Months - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
70916662|NCT04673851|141324044|OTHER|Single group mean difference between 1.5 month and post-treatment assessments.|Mean Difference (Net)|-2.04|STANDARD_DEVIATION|6.12|||TWO_SIDED|||||||||Posttreatment - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
70916663|NCT04673851|141324044|OTHER|Effect size of single group mean difference between 1.5 month and post-treatment assessments.|Cohen's d|0.33|||||TWO_SIDED|||||||||Posttreatment - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
70916664|NCT00880048|141324074|SUPERIORITY||Mean Difference (Net)|-1.6||||0.0133|TWO_SIDED|95.0|-2.87|-0.34|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 1||-0.34|-2.87|0.0133
70916665|NCT00880048|141324074|SUPERIORITY||Mean Difference (Net)|-2.26||||0.0006|TWO_SIDED|95.0|-3.54|-0.98|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 1||-0.98|-3.54|0.0006
70916666|NCT00880048|141324074|SUPERIORITY||Mean Difference (Net)|-1.57||||0.0394|TWO_SIDED|95.0|-3.06|-0.08|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2||-0.08|-3.06|0.0394
70916667|NCT00880048|141324074|SUPERIORITY||Mean Difference (Net)|-1.65||||0.0332|TWO_SIDED|95.0|-3.16|-0.13|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 2||-0.13|-3.16|0.0332
70916668|NCT00880048|141324074|SUPERIORITY||Mean Difference (Net)|-1.82||||0.0601|TWO_SIDED|95.0|-3.71|0.08|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 4||0.08|-3.71|0.0601
70916669|NCT00880048|141324074|SUPERIORITY||Mean Difference (Net)|-2.03||||0.0369|TWO_SIDED|95.0|-3.94|-0.12|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 4||-0.12|-3.94|0.0369
70916670|NCT00880048|141324074|SUPERIORITY||Mean Difference (Net)|-1.67||||0.1122|TWO_SIDED|95.0|-3.73|0.39|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 6||0.39|-3.73|0.1122
70916671|NCT00880048|141324074|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.76||||0.4713|TWO_SIDED|95.0|-2.85|1.32|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 6||1.32|-2.85|0.4713
70916672|NCT00880048|141324075|SUPERIORITY||Odds Ratio (OR)|2.15||||0.2232|TWO_SIDED|95.0|0.63|7.39|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 1||7.39|0.63|0.2232
70916673|NCT00880048|141324075|SUPERIORITY||Odds Ratio (OR)|3.15||||0.0559|TWO_SIDED|95.0|0.97|10.2|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 1||10.2|0.97|0.0559
70916674|NCT00880048|141324075|SUPERIORITY||Odds Ratio (OR)|1.52||||0.3395|TWO_SIDED|95.0|0.64|3.61|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 2||3.61|0.64|0.3395
70916675|NCT00880048|141324075|SUPERIORITY||Odds Ratio (OR)|1.44||||0.4256|TWO_SIDED|95.0|0.59|3.5|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 2||3.50|0.59|0.4256
71093050|NCT06001866|141693232|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
70916676|NCT00880048|141324075|SUPERIORITY||Odds Ratio (OR)|1.35||||0.379|TWO_SIDED|95.0|0.69|2.64|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 4||2.64|0.69|0.3790
70916677|NCT00880048|141324075|SUPERIORITY||Odds Ratio (OR)|1.47||||0.2554|TWO_SIDED|95.0|0.76|2.86|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 4||2.86|0.76|0.2554
70916678|NCT00880048|141324075|SUPERIORITY||Odds Ratio (OR)|1.53||||0.1961|TWO_SIDED|95.0|0.8|2.91|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 6||2.91|0.80|0.1961
70916679|NCT00880048|141324075|SUPERIORITY||Odds Ratio (OR)|1.15||||0.6916|TWO_SIDED|95.0|0.58|2.25|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 6||2.25|0.58|0.6916
70916680|NCT00880048|141324076|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.61|TWO_SIDED|95.0|0.5|1.95|||Log Rank|||||1.95|0.50|0.61
70916681|NCT00880048|141324076|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.35|TWO_SIDED|95.0|0.36|1.54|||Log Rank|||||1.54|0.36|0.35
70916682|NCT00880048|141324077|SUPERIORITY||Mean Difference (Net)|-0.69||||0.0362|TWO_SIDED|95.0|-1.34|-0.04|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 1||-0.04|-1.34|0.0362
70916683|NCT00880048|141324077|SUPERIORITY||Mean Difference (Net)|-0.81||||0.0155|TWO_SIDED|95.0|-1.46|-0.16|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 1||-0.16|-1.46|0.0155
70916684|NCT00880048|141324077|SUPERIORITY||Mean Difference (Net)|-0.46||||0.2593|TWO_SIDED|95.0|-1.27|0.34|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 2||0.34|-1.27|0.2593
70916685|NCT00880048|141324077|SUPERIORITY||Mean Difference (Net)|-0.62||||0.1407|TWO_SIDED|95.0|-1.44|0.2|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 2||0.20|-1.44|0.1407
70916686|NCT00880048|141324077|SUPERIORITY||Mean Difference (Net)|-0.67||||0.1933|TWO_SIDED|95.0|-1.67|0.34|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 4||0.34|-1.67|0.1933
70916687|NCT00880048|141324077|SUPERIORITY||Mean Difference (Net)|-0.74||||0.15|TWO_SIDED|95.0|-1.76|0.27|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 4||0.27|-1.76|0.1500
70916688|NCT00880048|141324077|SUPERIORITY||Mean Difference (Net)|-1.09||||0.055|TWO_SIDED|95.0|-2.21|0.02|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 6||0.02|-2.21|0.0550
70916689|NCT00880048|141324077|SUPERIORITY||Mean Difference (Net)|-0.52||||0.3627|TWO_SIDED|95.0|-1.65|0.61|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 6||0.61|-1.65|0.3627
71093051|NCT06001866|141693233|SUPERIORITY||||||=|0.78|||||||LSD test|||||||=0.78
71093052|NCT06001866|141693233|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<.00001
71093053|NCT06001866|141693234|SUPERIORITY||||||=|1|||||||LSD test|||||||=1.00
71093054|NCT06001866|141693234|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
71093055|NCT06001866|141693235|SUPERIORITY||||||=|0.75|||||||LSD test|||||||=0.75
71093056|NCT06001866|141693235|SUPERIORITY||||||<|0.01|||||||LSD test|||||||<0.01
71093057|NCT06001866|141693236|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
70916690|NCT00880048|141324078|SUPERIORITY||Mean Difference (Net)|-1.03||||0.0616|TWO_SIDED|95.0|-2.11|0.05|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 1||0.05|-2.11|0.0616
70916691|NCT00880048|141324078|SUPERIORITY||Mean Difference (Net)|-2.28|||<|0.0001|TWO_SIDED|95.0|-3.36|-1.19|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 1||-1.19|-3.36|<0.0001
70916692|NCT00880048|141324078|SUPERIORITY||Mean Difference (Net)|-1.44||||0.0239|TWO_SIDED|95.0|-2.68|-0.19|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 2||-0.19|-2.68|0.0239
70916693|NCT00880048|141324078|SUPERIORITY||Mean Difference (Net)|-1.84||||0.0048|TWO_SIDED|95.0|-3.12|-0.57|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 2||-0.57|-3.12|0.0048
70916694|NCT00880048|141324078|SUPERIORITY||Mean Difference (Net)|-1.58||||0.027|TWO_SIDED|95.0|-2.97|-0.18|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 4||-0.18|-2.97|0.0270
70916695|NCT00880048|141324078|SUPERIORITY||Mean Difference (Net)|-1.86||||0.0103|TWO_SIDED|95.0|-3.27|-0.44|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 4||-0.44|-3.27|0.0103
70916696|NCT00880048|141324078|SUPERIORITY||Mean Difference (Net)|-1.53||||0.0497|TWO_SIDED|95.0|-3.06|0.0|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 6||-0.00|-3.06|0.0497
70916697|NCT00880048|141324078|SUPERIORITY||Mean Difference (Net)|-1.41||||0.0794|TWO_SIDED|95.0|-2.98|0.17|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 6||0.17|-2.98|0.0794
70916698|NCT00880048|141324079|SUPERIORITY||Mean Difference (Net)|-0.28||||0.24|TWO_SIDED|95.0|-0.75|0.19|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 1||0.19|-0.75|0.2400
70916699|NCT00880048|141324079|SUPERIORITY||Mean Difference (Net)|-0.76||||0.002|TWO_SIDED|95.0|-1.23|-0.28|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 1||-0.28|-1.23|0.0020
70916700|NCT00880048|141324079|SUPERIORITY||Mean Difference (Net)|-0.15||||0.5605|TWO_SIDED|95.0|-0.67|0.36|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 2||0.36|-0.67|0.5605
70916701|NCT00880048|141324079|SUPERIORITY||Mean Difference (Net)|-0.33||||0.2215|TWO_SIDED|95.0|-0.86|0.2|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 2||0.20|-0.86|0.2215
70916702|NCT00880048|141324079|SUPERIORITY||Mean Difference (Net)|-0.35||||0.287|TWO_SIDED|95.0|-1.01|0.3|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 4||0.30|-1.01|0.2870
70916703|NCT00880048|141324079|SUPERIORITY||Mean Difference (Net)|-0.67||||0.0465|TWO_SIDED|95.0|-1.33|-0.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 4||-0.01|-1.33|0.0465
70916704|NCT00880048|141324079|SUPERIORITY||Mean Difference (Net)|-0.32||||0.3399|TWO_SIDED|95.0|-0.99|0.34|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 6||0.34|-0.99|0.3399
70916705|NCT00880048|141324079|SUPERIORITY||Mean Difference (Net)|-0.18||||0.5931|TWO_SIDED|95.0|-0.86|0.49|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 6||0.49|-0.86|0.5931
70916706|NCT00880048|141324080|SUPERIORITY||Odds Ratio (OR)|2.83||||0.0562|TWO_SIDED|95.0|0.97|8.22|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 1||8.22|0.97|0.0562
70916707|NCT00880048|141324080|SUPERIORITY||Odds Ratio (OR)|2.22||||0.1596|TWO_SIDED|95.0|0.73|6.73|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 1||6.73|0.73|0.1596
70916708|NCT00880048|141324080|SUPERIORITY||Odds Ratio (OR)|2.91||||0.0067|TWO_SIDED|95.0|1.34|6.3|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 2||6.30|1.34|0.0067
70916709|NCT00880048|141324080|SUPERIORITY||Odds Ratio (OR)|1.93||||0.1154|TWO_SIDED|95.0|0.85|4.36|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 2||4.36|0.85|0.1154
70916710|NCT00880048|141324080|SUPERIORITY||Odds Ratio (OR)|1.13||||0.6895|TWO_SIDED|95.0|0.62|2.07|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 4||2.07|0.62|0.6895
70916711|NCT00880048|141324080|SUPERIORITY||Odds Ratio (OR)|1.32||||0.3654|TWO_SIDED|95.0|0.72|2.41|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 4||2.41|0.72|0.3654
70916712|NCT00880048|141324080|SUPERIORITY||Odds Ratio (OR)|1.44||||0.2408|TWO_SIDED|95.0|0.78|2.65|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 6||2.65|0.78|0.2408
70916713|NCT00880048|141324080|SUPERIORITY||Odds Ratio (OR)|1.39||||0.3066|TWO_SIDED|95.0|0.74|2.6|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 6||2.60|0.74|0.3066
70916714|NCT00880048|141324081|SUPERIORITY||Mean Difference (Net)|-0.15||||0.1472|TWO_SIDED|95.0|-0.36|0.05|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 1||0.05|-0.36|0.1472
70916715|NCT00880048|141324081|SUPERIORITY||Mean Difference (Net)|-0.27||||0.0107|TWO_SIDED|95.0|-0.48|-0.06|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 1||-0.06|-0.48|0.0107
70916716|NCT00880048|141324081|SUPERIORITY||Mean Difference (Net)|-0.25||||0.0603|TWO_SIDED|95.0|-0.51|0.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 2||0.01|-0.51|0.0603
70916717|NCT00880048|141324081|SUPERIORITY||Mean Difference (Net)|-0.2||||0.1458|TWO_SIDED|95.0|-0.46|0.07|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 2||0.07|-0.46|0.1458
70916718|NCT00880048|141324081|SUPERIORITY||Mean Difference (Net)|-0.27||||0.0941|TWO_SIDED|95.0|-0.58|0.05|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 4||0.05|-0.58|0.0941
70916719|NCT00880048|141324081|SUPERIORITY||Mean Difference (Net)|-0.27||||0.088|TWO_SIDED|95.0|-0.59|0.04|||Mixed Models Repeated Measures||Placebo vs GW823296 60mg: Week 4|||0.04|-0.59|0.0880
70916720|NCT00880048|141324081|SUPERIORITY||Mean Difference (Net)|-0.38||||0.0313|TWO_SIDED|95.0|-0.73|-0.03|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 6||-0.03|-0.73|0.0313
70916721|NCT00880048|141324081|SUPERIORITY||Mean Difference (Net)|-0.2||||0.2639|TWO_SIDED|95.0|-0.55|0.15|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 6||0.15|-0.55|0.2639
70916722|NCT00880048|141324082|SUPERIORITY||Mean Difference (Net)|-1.57||||0.0421|TWO_SIDED|95.0|-3.08|-0.06|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1||-0.06|-3.08|0.0421
70916723|NCT00880048|141324082|SUPERIORITY||Mean Difference (Net)|-0.74||||0.3394|TWO_SIDED|95.0|-2.27|0.78|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1||0.78|-2.27|0.3394
70916724|NCT00880048|141324082|SUPERIORITY||Mean Difference (Net)|-1.4||||0.0963|TWO_SIDED|95.0|-3.05|0.25|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2||0.25|-3.05|0.0963
70916725|NCT00880048|141324082|SUPERIORITY||Mean Difference (Net)|-1.94||||0.0235|TWO_SIDED|95.0|-3.62|-0.26|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2||-0.26|-3.62|0.0235
70916726|NCT00880048|141324082|SUPERIORITY||Mean Difference (Net)|-0.77||||0.3956|TWO_SIDED|95.0|-2.54|1.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4||1.01|-2.54|0.3956
71093058|NCT06001866|141693236|SUPERIORITY||||||=|0.62|||||||LSD test|||||||=0.62
70916727|NCT00880048|141324082|SUPERIORITY||Mean Difference (Net)|-0.73||||0.4273|TWO_SIDED|95.0|-2.53|1.07|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4||1.07|-2.53|0.4273
70916728|NCT00880048|141324082|SUPERIORITY||Mean Difference (Net)|-0.94||||0.3429|TWO_SIDED|95.0|-2.89|1.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6||1.01|-2.89|0.3429
70916729|NCT00880048|141324082|SUPERIORITY||Mean Difference (Net)|-1.19||||0.2403|TWO_SIDED|95.0|-3.18|0.8|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6||0.80|-3.18|0.2403
70916730|NCT00880048|141324083|SUPERIORITY||Mixed effects repeated measures model|22.52||||0.103|TWO_SIDED|95.0|-4.58|49.61|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1, total sleep time||49.61|-4.58|0.1030
70916731|NCT00880048|141324083|SUPERIORITY||Mean Difference (Net)|33.21||||0.0179|TWO_SIDED|95.0|5.76|60.65|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1, total sleep time||60.65|5.76|0.0179
70916732|NCT00880048|141324083|SUPERIORITY||Mean Difference (Net)|7.62||||0.5773|TWO_SIDED|95.0|-19.25|34.49|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2, total sleep time||34.49|-19.25|0.5773
70916733|NCT00880048|141324083|SUPERIORITY||Mean Difference (Net)|21.4||||0.125|TWO_SIDED|95.0|-5.97|48.76|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2, total sleep time||48.76|-5.97|0.1250
70916734|NCT00880048|141324083|SUPERIORITY||Mean Difference (Net)|30.87||||0.0344|TWO_SIDED|95.0|2.29|59.45|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4, total sleep time||59.45|2.29|0.0344
70916735|NCT00880048|141324083|SUPERIORITY||Mean Difference (Net)|36.52||||0.0131|TWO_SIDED|95.0|7.72|65.32|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4, total sleep time||65.32|7.72|0.0131
70916736|NCT00880048|141324083|SUPERIORITY||Mean Difference (Net)|2.18||||0.8794|TWO_SIDED|95.0|-26.1|30.46|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6, total sleep time||30.46|-26.10|0.8794
70916737|NCT00880048|141324083|SUPERIORITY||Mean Difference (Net)|28.4||||0.0556|TWO_SIDED|95.0|-0.69|57.5|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6, total sleep time||57.50|-0.69|0.0556
70916738|NCT00880048|141324083|SUPERIORITY||Mean Difference (Net)|-23.9||||0.0078|TWO_SIDED|95.0|-41.46|-6.33|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1, sleep onset latency||-6.33|-41.46|0.0078
70916739|NCT00880048|141324083|SUPERIORITY||Mean Difference (Net)|-25.49||||0.0052|TWO_SIDED|95.0|-43.3|-7.68|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1, sleep onset latency||-7.68|-43.30|0.0052
70916740|NCT00880048|141324083|SUPERIORITY||Mean Difference (Net)|-12.45||||0.2373|TWO_SIDED|95.0|-33.14|8.24|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2, sleep onset latency||8.24|-33.14|0.2373
70916741|NCT00880048|141324083|SUPERIORITY||Mean Difference (Net)|1.75||||0.8707|TWO_SIDED|95.0|-19.38|22.87|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2, sleep onset latency||22.87|-19.38|0.8707
70916742|NCT00880048|141324083|SUPERIORITY||Mean Difference (Net)|-12.92||||0.1933|TWO_SIDED|95.0|-32.43|6.59|||Mixed Models Repeated Measures|||Placebo va GW823296 30 mg: Week 4, sleep onset latency||6.59|-32.43|0.1933
70916743|NCT00880048|141324083|SUPERIORITY||Mean Difference (Net)|-10.55||||0.2933|TWO_SIDED|95.0|-30.26|9.17|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4, sleep onset latency||9.17|-30.26|0.2933
70916744|NCT00880048|141324083|SUPERIORITY||Mean Difference (Net)|-28.58||||0.0177|TWO_SIDED|95.0|-52.15|-5.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6, sleep onset latency||-5.01|-52.15|0.0177
70916745|NCT00880048|141324083|SUPERIORITY||Mean Difference (Net)|-30.07||||0.0152|TWO_SIDED|95.0|-54.29|-5.84|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6, sleep onset latency||-5.84|-54.29|0.0152
70916746|NCT00880048|141324083|SUPERIORITY||Mean Difference (Net)|-17.19||||0.0108|TWO_SIDED|95.0|-30.36|-4.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1, wake time after sleep onset||-4.01|-30.36|0.0108
70916747|NCT00880048|141324083|SUPERIORITY||Mean Difference (Net)|-16.15||||0.019|TWO_SIDED|95.0|-29.61|-2.68|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1, wake time after sleep onset||-2.68|-29.61|0.0190
70916748|NCT00880048|141324083|SUPERIORITY||Mean Difference (Net)|1.89||||0.8195|TWO_SIDED|95.0|-14.43|18.21|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2, wake time after sleep onset||18.21|-14.43|0.8195
70916749|NCT00880048|141324083|SUPERIORITY||Mean Difference (Net)|5.27||||0.5327|TWO_SIDED|95.0|-11.35|21.89|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2, wake time after sleep onset||21.89|-11.35|0.5327
70916750|NCT00880048|141324083|SUPERIORITY||Mean Difference (Net)|-2.5||||0.7387|TWO_SIDED|95.0|-17.24|12.25|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4, wake time after sleep onset||12.25|-17.24|0.7387
70916751|NCT00880048|141324083|SUPERIORITY||Mean Difference (Net)|-9.44||||0.2134|TWO_SIDED|95.0|-24.35|5.48|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4, wake time after sleep onset||5.48|-24.35|0.2134
70916752|NCT00880048|141324083|SUPERIORITY||Mean Difference (Net)|-14.51||||0.1561|TWO_SIDED|95.0|-34.61|5.6|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6, wake time after sleep onset||5.60|-34.61|0.1561
70916753|NCT00880048|141324083|SUPERIORITY||Mean Difference (Net)|-17.1||||0.1054|TWO_SIDED|95.0|-37.84|3.64|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6, wake time after sleep onset||3.64|-37.84|0.1054
70916754|NCT00880048|141324084|SUPERIORITY||Mean Difference (Net)|-0.57||||0.0024|TWO_SIDED|95.0|-0.94|-0.21|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1||-0.21|-0.94|0.0024
70916755|NCT00880048|141324084|SUPERIORITY||Mean Difference (Net)|-0.1||||0.6146|TWO_SIDED|95.0|-0.47|0.28|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1||0.28|-0.47|0.6146
70916756|NCT00880048|141324084|SUPERIORITY||Mean Difference (Net)|-0.25||||0.1442|TWO_SIDED|95.0|-0.59|0.09|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2||0.09|-0.59|0.1442
70916757|NCT00880048|141324084|SUPERIORITY||Mean Difference (Net)|0.04||||0.8001|TWO_SIDED|95.0|-0.3|0.39|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2||0.39|-0.30|0.8001
70916758|NCT00880048|141324084|SUPERIORITY||Mean Difference (Net)|-0.05||||0.8439|TWO_SIDED|95.0|-0.55|0.45|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4||0.45|-0.55|0.8439
70916759|NCT00880048|141324084|SUPERIORITY||Mean Difference (Net)|-0.4||||0.1259|TWO_SIDED|95.0|-0.91|0.11|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4||0.11|-0.91|0.1259
70916760|NCT00880048|141324084|SUPERIORITY||Mean Difference (Net)|0.2||||0.3709|TWO_SIDED|95.0|-0.24|0.64|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6||0.64|-0.24|0.3709
70916761|NCT00880048|141324084|SUPERIORITY||Mean Difference (Net)|-0.24||||0.2993|TWO_SIDED|95.0|-0.7|0.22|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6||0.22|-0.70|0.2993
70916762|NCT00880048|141324085|SUPERIORITY||Mean Difference (Net)|0.59||||0.0344|TWO_SIDED|95.0|0.04|1.14|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1, sleep quality||1.14|0.04|0.0344
70916763|NCT00880048|141324085|SUPERIORITY||Mean Difference (Net)|0.72||||0.0111|TWO_SIDED|95.0|0.17|1.27|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1, sleep quality||1.27|0.17|0.0111
70916764|NCT00880048|141324085|SUPERIORITY||Mean Difference (Net)|0.42||||0.1443|TWO_SIDED|95.0|-0.15|0.99|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2, sleep quality||0.99|-0.15|0.1443
70916765|NCT00880048|141324085|SUPERIORITY||Mean Difference (Net)|0.5||||0.0873|TWO_SIDED|95.0|-0.07|1.08|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2, sleep quality||1.08|-0.07|0.0873
70916766|NCT00880048|141324085|SUPERIORITY||Mean Difference (Net)|0.73||||0.017|TWO_SIDED|95.0|0.13|1.33|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4, sleep quality||1.33|0.13|0.0170
70916767|NCT00880048|141324085|SUPERIORITY||Mean Difference (Net)|0.42||||0.1675|TWO_SIDED|95.0|-0.18|1.02|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4, sleep quality||1.02|-0.18|0.1675
70916768|NCT00880048|141324085|SUPERIORITY||Mean Difference (Net)|0.56||||0.0956|TWO_SIDED|95.0|-0.1|1.23|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6, sleep quality||1.23|-0.10|0.0956
70916769|NCT00880048|141324085|SUPERIORITY||Mean Difference (Net)|0.32||||0.3503|TWO_SIDED|95.0|-0.35|1.0|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6, sleep quality||1.00|-0.35|0.3503
70916770|NCT00880048|141324085|SUPERIORITY||Mean Difference (Net)|0.34||||0.2147|TWO_SIDED|95.0|-0.2|0.88|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1, refreshing value of sleep||0.88|-0.20|0.2147
70916771|NCT00880048|141324085|SUPERIORITY||Mean Difference (Net)|0.63||||0.0233|TWO_SIDED|95.0|0.09|1.17|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1, refreshing value of sleep||1.17|0.09|0.0233
70916772|NCT00880048|141324085|SUPERIORITY||Mean Difference (Net)|0.33||||0.2404|TWO_SIDED|95.0|-0.22|0.89|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2, refreshing value of sleep||0.89|-0.22|0.2404
70916773|NCT00880048|141324085|SUPERIORITY||Mean Difference (Net)|0.65||||0.0247|TWO_SIDED|95.0|0.08|1.22|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2, refreshing value of sleep||1.22|0.08|0.0247
70916774|NCT00880048|141324085|SUPERIORITY||Mean Difference (Net)|0.69||||0.0271|TWO_SIDED|95.0|0.08|1.29|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4, refreshing value of sleep||1.29|0.08|0.0271
70916775|NCT00880048|141324085|SUPERIORITY||Mean Difference (Net)|0.39||||0.2129|TWO_SIDED|95.0|-0.22|1.0|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4, refreshing value of sleep||1.00|-0.22|0.2129
71093059|NCT06001866|141693237|SUPERIORITY||||||=|0.16|||||||LSD test|||||||=0.16
70916776|NCT00880048|141324085|SUPERIORITY||Mean Difference (Net)|0.37||||0.2874|TWO_SIDED|95.0|-0.31|1.06|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6, refreshing value of sleep||1.06|-0.31|0.2874
70916777|NCT00880048|141324085|SUPERIORITY||Mean Difference (Net)|0.71||||0.0472|TWO_SIDED|95.0|0.01|1.41|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6, refreshing value of sleep||1.41|0.01|0.0472
70916778|NCT00880048|141324086|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9824|TWO_SIDED|95.0|0.13|7.09|||Regression, Logistic|||Placebo vs GW823296 30 mg: Week 1||7.09|0.13|0.9824
70916779|NCT00880048|141324086|SUPERIORITY||Odds Ratio (OR)|0.54||||0.6227|TWO_SIDED|95.0|0.05|6.13|||Regression, Logistic|||Placebo vs GW823296 60 mg: Week 1||6.13|0.05|0.6227
70916780|NCT00880048|141324086|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9967|TWO_SIDED|95.0|0.2|5.07|||Regression, Logistic|||Placebo vs GW823296 30 mg: Week 2||5.07|0.20|0.9967
70916781|NCT00880048|141324086|SUPERIORITY||Odds Ratio (OR)|2.0||||0.355|TWO_SIDED|95.0|0.46|8.63|||Regression, Logistic|||Placebo vs GW823296 60 mg: Week 2||8.63|0.46|0.3550
70916782|NCT00880048|141324086|SUPERIORITY||Odds Ratio (OR)|2.35||||0.1009|TWO_SIDED|95.0|0.85|6.49|||Regression, Logistic|||Placebo vs GW823296 30 mg: Week 4||6.49|0.85|0.1009
70916783|NCT00880048|141324086|SUPERIORITY||Odds Ratio (OR)|2.8||||0.0455|TWO_SIDED|95.0|1.02|7.68|||Regression, Logistic|||Placebo vs GW823296 60 mg: Week 4||7.68|1.02|0.0455
70916784|NCT00880048|141324086|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0507|TWO_SIDED|95.0|1.0|5.32|||Regression, Logistic|||Placebo vs GW823296 30 mg: Week 6||5.32|1.00|0.0507
70916785|NCT00880048|141324086|SUPERIORITY||Odds Ratio (OR)|1.38||||0.4962|TWO_SIDED|95.0|0.55|3.45|||Regression, Logistic|||Placebo vs GW823296 60 mg: Week 6||3.45|0.55|0.4962
70916786|NCT00880048|141324089|SUPERIORITY||Mean Difference (Net)|1.03||||0.3241|TWO_SIDED|95.0|-1.03|3.1|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1||3.10|-1.03|0.3241
70916787|NCT00880048|141324089|SUPERIORITY||Mean Difference (Net)|-0.56||||0.602|TWO_SIDED|95.0|-2.66|1.55|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1||1.55|-2.66|0.6020
70916788|NCT00880048|141324089|SUPERIORITY||Mean Difference (Net)|2.44||||0.0594|TWO_SIDED|95.0|-0.1|4.99|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2||4.99|-0.10|0.0594
70916789|NCT00880048|141324089|SUPERIORITY||Mean Difference (Net)|0.92||||0.4828|TWO_SIDED|95.0|-1.67|3.5|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2||3.50|-1.67|0.4828
70916790|NCT00880048|141324089|SUPERIORITY||Mean Difference (Net)|0.19||||0.9008|TWO_SIDED|95.0|-2.8|3.18|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4||3.18|-2.80|0.9008
70916791|NCT00880048|141324089|SUPERIORITY||Mean Difference (Net)|-0.71||||0.6428|TWO_SIDED|95.0|-3.74|2.32|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4||2.32|-3.74|0.6428
70916792|NCT00880048|141324089|SUPERIORITY||Mean Difference (Net)|-0.68||||0.6911|TWO_SIDED|95.0|-4.06|2.7|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6||2.70|-4.06|0.6911
70916793|NCT00880048|141324089|SUPERIORITY||Odds Ratio (OR)|-0.67||||0.7026|TWO_SIDED|95.0|-4.14|2.8|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6||2.80|-4.14|0.7026
70916794|NCT00880048|141324090|SUPERIORITY||Mean Difference (Net)|-0.97||||0.1301|TWO_SIDED|95.0|-2.24|0.29|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1||0.29|-2.24|0.1301
71093060|NCT06001866|141693237|SUPERIORITY||||||=|0.33|||||||LSD test|||||||=0.33
71093061|NCT06001866|141693238|SUPERIORITY||||||=|0.54|||||||t-test, 2 sided|||||||=.54
71093062|NCT06001866|141693239|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
70916795|NCT00880048|141324090|SUPERIORITY||Mean Difference (Net)|0.47||||0.4644|TWO_SIDED|95.0|-0.79|1.73|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1||1.73|-0.79|0.4644
70916796|NCT00880048|141324090|SUPERIORITY||Mean Difference (Net)|-0.76||||0.3382|TWO_SIDED|95.0|-2.33|0.8|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2||0.80|-2.33|0.3382
70916797|NCT00880048|141324090|SUPERIORITY||Mean Difference (Net)|0.94||||0.241|TWO_SIDED|95.0|-0.63|2.51|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2||2.51|-0.63|0.2410
70916798|NCT00880048|141324090|SUPERIORITY||Mean Difference (Net)|-0.98||||0.2768|TWO_SIDED|95.0|-2.75|0.79|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4||0.79|-2.75|0.2768
70916799|NCT00880048|141324090|SUPERIORITY||Mean Difference (Net)|0.06||||0.9434|TWO_SIDED|95.0|-1.7|1.83|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4||1.83|-1.70|0.9434
70916800|NCT00880048|141324090|SUPERIORITY||Mean Difference (Net)|-0.55||||0.5796|TWO_SIDED|95.0|-2.49|1.4|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6||1.40|-2.49|0.5796
70916801|NCT00880048|141324090|SUPERIORITY||Mean Difference (Net)|0.71||||0.4753|TWO_SIDED|95.0|-1.24|2.66|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6||2.66|-1.24|0.4753
70916802|NCT00346151|141324092|SUPERIORITY_OR_OTHER||Incidence Rate|60.0||||||95.0|15.0|95.0|||95% exact binomial CI of proportion|||Proportion of participant's cumulative incidence of acute rejection at 24 weeks with 95% exact binomial confidence interval. Local biopsy reads were used in determining primary endpoint.||95|15|
70916803|NCT00346151|141324093|SUPERIORITY_OR_OTHER||Incidence Rate|100.0||||||95.0|40.0|100.0|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||100|40|
71093063|NCT02903914|141693247|OTHER|||||||0.0731|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.0731
71153912|NCT00488683|141800065|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.03||||0.74||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup W-135||||0.74
70916804|NCT00346151|141324094|SUPERIORITY_OR_OTHER||Incidence rate|80.0||||||95.0|28.0|99.0|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||99|28|
70916805|NCT00346151|141324097|SUPERIORITY_OR_OTHER||Incidence Rate|100.0||||||95.0|40.0|100.0|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||100|40|
70916806|NCT00346151|141324099|SUPERIORITY_OR_OTHER||Incidence Rate|0.0||||||95.0|0.0|52.2|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||52.2|0|
70916807|NCT00346151|141324100|SUPERIORITY_OR_OTHER||Incidence Rate|80.0||||||95.0|28.0|99.0|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||99|28|
70916808|NCT00346151|141324101|SUPERIORITY_OR_OTHER||Incidence Rate|0.0||||||95.0|0.0|52.2|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||52.2|0|
70916809|NCT00346151|141324102|SUPERIORITY_OR_OTHER||Incidence Rate|0.0||||||95.0|0.0|52.2|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||52.2|0|
70916810|NCT00346151|141324103|SUPERIORITY_OR_OTHER||Incidence Rate|100.0||||||95.0|47.8|100.0|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||100|47.8|
70916811|NCT00346151|141324104|SUPERIORITY_OR_OTHER||Incidence Rate|0.0||||||95.0|0.0|52.2|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||52.2|0|
71153913|NCT00488683|141800065|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.03||||0.74||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup Y||||0.74
70916812|NCT00346151|141324105|SUPERIORITY_OR_OTHER||Incidence Rate|0.0||||||95.0|0.0|52.2|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||52.2|0|
70916813|NCT00346151|141324106|SUPERIORITY_OR_OTHER||Incidence Rate|20.0||||||95.0|0.5|71.6|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||71.6|0.5|
70916814|NCT03684265|141324115|EQUIVALENCE|Bioequivalence acceptance range for the ratio of geometric means was 80- 125%|Geometric mean ratio T/R, %|92.74|STANDARD_ERROR_OF_MEAN|8.66|||TWO_SIDED|95.0|89.02|96.62|||||Standard error of the mean is actually intra individual coefficient of variation.|Relative bioavailability comparison of Movalis® capsules (T) with Movalis® tablets (R) for AUC0-t. The analysis of variance (ANOVA) model in the log scale was used. This model included the sequence, period and type of therapy as fixed effects and the effect study subjects grouped within the sequence was considered random||96.62|89.02|
70916815|NCT03684265|141324116|EQUIVALENCE|Bioequivalence acceptance range for the ratio of geometric means was 80- 125%|Geometric mean ratio T/R, %|78.94|STANDARD_ERROR_OF_MEAN|14.57|||TWO_SIDED|90.0|73.7|84.56|||||Standard error of the mean is actually intra individual coefficient of variation.|Relative bioavailability comparison of Movalis® capsules (T) with Movalis® tablets (R) for Cmax. The analysis of variance (ANOVA) model in the log scale was used. This model included the sequence, period and type of therapy as fixed effects and the effect study subjects grouped within the sequence was considered random||84.56|73.70|
70916816|NCT03684265|141324117|EQUIVALENCE|Bioequivalence acceptance range for the ratio of geometric means was 80- 125%|Geometric mean ratio T/R, %|97.04|STANDARD_ERROR_OF_MEAN|9.96|||TWO_SIDED|90.0|92.57|101.72|||||Standard error of the mean is actually intra individual coefficient of variation.|Relative bioavailability comparison of Movalis® capsules (T) with Movalis® tablets (R) for AUC0-∞. The analysis of variance (ANOVA) model in the log scale was used. This model included the sequence, period and type of therapy as fixed effects and the effect study subjects grouped within the sequence was considered random||101.72|92.57|
70916817|NCT01215695|141324169|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70916818|NCT01215695|141324170|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70916819|NCT01215695|141324171|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
70916820|NCT01215695|141324172|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
70916821|NCT01215695|141324173|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71093064|NCT02903914|141693247|OTHER||pairwise geometric mean ratio (GMR)|0.933|||||TWO_SIDED|90.0|0.784|1.11||||||||1.110|0.784|
71093065|NCT02903914|141693247|OTHER||pairwise GMR|1.074|||||TWO_SIDED|90.0|0.908|1.271||||||||1.271|0.908|
70916822|NCT01378065|141324254|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
71093066|NCT02903914|141693247|OTHER||pairwise GMR|1.23|||||TWO_SIDED|90.0|1.034|1.463||||||||1.463|1.034|
71093067|NCT02903914|141693248|OTHER|||||||0.1496|||||||Kruskal-Wallis|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.1496
71093068|NCT02903914|141693249|OTHER|||||||0.2867|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.2867
70916823|NCT01378065|141324255|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
70916824|NCT01378065|141324256|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
70916825|NCT01378065|141324257|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
70916826|NCT01378065|141324258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.202|TWO_SIDED||||||t-test, 2 sided|||||||0.202
70916827|NCT01378065|141324259|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
70916828|NCT01378065|141324260|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||||||0.004
70916829|NCT01378065|141324261|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034|TWO_SIDED||||||t-test, 2 sided|||||||0.034
70916830|NCT01378065|141324262|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||Analysis baseline to 6 weeks.||||0.001
70916831|NCT01378065|141324263|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||Analysis baseline to 3 months.||||0.004
70916832|NCT01378065|141324264|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Analysis baseline to 6 months.||||<.001
70916833|NCT01378065|141324265|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Analysis baseline to 12 months.||||<.001
70916834|NCT00094575|141324300|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.81|TWO_SIDED|95.0|0.77|1.22|||Log Rank||The HR was estimated by comparing Endovascular repair arm vs the Open repair arm.|The primary outcome was long-term, all-cause mortality. The sample size would provide 80% power to detect a 25% relative reduction in mortality at a two-sided alpha level of 0.05. The primary comparison was the main effects of Endovascular repair vs Open repair of AAA.||1.22|0.77|0.81
70916835|NCT00094575|141324301|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Chi-squared|||||||0.12
70916836|NCT00094575|141324302|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||Mixed Models Analysis|||||||0.81
70916837|NCT00094575|141324303|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||0.80
70916838|NCT00094575|141324304|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Mixed Models Analysis|||||||0.78
70916839|NCT00094575|141324305|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Mixed Models Analysis|||Note: Since this is measuring change over time since baseline, values could be below 0.||||0.58
70916840|NCT00094575|141324306|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Mixed Models Analysis|||||||0.37
70916841|NCT00094575|141324307|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||Mixed Models Analysis|||||||0.68
70916842|NCT00430300|141324309|SUPERIORITY_OR_OTHER||NDLM estimate difference|-0.0087||||0.0284|TWO_SIDED|95.0|-0.0943|0.0774|||Bayesian NDLM model|||The Bayesian normal dynamic linear model (NDLM) was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of 0.075 liter from placebo.||0.0774|-0.0943|0.0284
70916843|NCT00430300|141324309|SUPERIORITY_OR_OTHER||NDLM estimate difference|-0.0389||||0.0056|TWO_SIDED|95.0|-0.1299|0.0471|||Bayesian NDLM model|||The Bayesian normal dynamic linear model (NDLM) was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of 0.075 liter from placebo.||0.0471|-0.1299|0.0056
70916844|NCT00430300|141324309|SUPERIORITY_OR_OTHER||NDLM estimate difference|-0.051||||0.0009|TWO_SIDED|95.0|-0.1298|0.029|||Bayesian NDLM model|||The Bayesian normal dynamic linear model (NDLM) was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of 0.075 liter from placebo.||0.0290|-0.1298|0.0009
70916845|NCT00430300|141324310|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.5849|ONE_SIDED|95.0|-0.09||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.09|0.5849
70916846|NCT00430300|141324310|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.9737|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.9737
70916847|NCT00430300|141324310|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.387|ONE_SIDED|95.0|-0.06||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.06|0.3870
70916848|NCT00430300|141324310|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.8612|ONE_SIDED|95.0|-0.15||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.15|0.8612
70970747|NCT01964352|141447197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028|STANDARD_ERROR_OF_MEAN|0.019||0.1381|TWO_SIDED|95.0|-0.009|0.066|||Mixed Effects Model for Repeated Measure|||||0.066|-0.009|0.1381
71093069|NCT02903914|141693249|OTHER||pairwise GMR|1.007|||||TWO_SIDED|90.0|0.825|1.23||||||||1.230|0.825|
71093070|NCT02903914|141693249|OTHER||pairwise GMR|1.081|||||TWO_SIDED|90.0|0.892|1.311||||||||1.311|0.892|
71093071|NCT02903914|141693249|OTHER||pairwise GMR|1.234|||||TWO_SIDED|90.0|1.011|1.507||||||||1.507|1.011|
71093072|NCT02903914|141693250|OTHER|||||||0.6167|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.6167
71093073|NCT02903914|141693250|OTHER||pairwise GMR|1.014|||||TWO_SIDED|90.0|0.82|1.255||||||||1.255|0.820|
71093074|NCT02903914|141693250|OTHER||pairwise GMR|1.043|||||TWO_SIDED|90.0|0.849|1.281||||||||1.281|0.849|
71093075|NCT02903914|141693250|OTHER||pairwise GMR|1.17|||||TWO_SIDED|90.0|0.945|1.447||||||||1.447|0.945|
70916849|NCT00430300|141324310|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.05||0.7499|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.7499
70916850|NCT00430300|141324310|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.5134|ONE_SIDED|95.0|-0.08||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.08|0.5134
70916851|NCT00430300|141324310|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.07||0.1244|ONE_SIDED|95.0|-0.04||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.04|0.1244
70916852|NCT00430300|141324310|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.53|ONE_SIDED|95.0|-0.12||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.12|0.5300
70916853|NCT00430300|141324310|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.06||0.055|ONE_SIDED|95.0|0.0||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.00|0.0550
70916854|NCT00430300|141324311|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.7444|ONE_SIDED|95.0|-0.16||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.16|0.7444
70916855|NCT00430300|141324311|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.9134|ONE_SIDED|95.0|-0.21||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.21|0.9134
70916856|NCT00430300|141324311|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.6841|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.6841
70916857|NCT00430300|141324311|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.9283|ONE_SIDED|95.0|-0.23||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.23|0.9283
71153914|NCT00488683|141800065|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.18||||0.05||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup A||||0.05
70916858|NCT00430300|141324311|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.07||0.2991|ONE_SIDED|95.0|-0.08||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.08|0.2991
70916859|NCT00430300|141324311|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.06||0.7403|ONE_SIDED|95.0|-0.15||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.15|0.7403
70916860|NCT00430300|141324311|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.09||0.3499|ONE_SIDED|95.0|-0.11||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.11|0.3499
70916861|NCT00430300|141324311|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.08||0.2734|ONE_SIDED|95.0|-0.09||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.09|0.2734
70916862|NCT00430300|141324311|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.5806|ONE_SIDED|95.0|-0.14||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.14|0.5806
70916863|NCT00430300|141324311|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.11||0.054|ONE_SIDED|95.0|0.0||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.00|0.0540
70916864|NCT00430300|141324311|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.1||0.2616|ONE_SIDED|95.0|-0.11||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.11|0.2616
70916865|NCT00430300|141324311|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.09||0.0724|ONE_SIDED|95.0|-0.02||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.02|0.0724
70916866|NCT00430300|141324312|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.1||0.9362|ONE_SIDED|95.0|-0.32||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.32|0.9362
70970748|NCT01964352|141447197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.113|0.188|||Mixed Effects Model for Repeated Measure|||||0.188|0.113|<0.0001
71093076|NCT02903914|141693254|OTHER|||||||0.0745|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.0745
70916867|NCT00430300|141324312|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.9469|ONE_SIDED|95.0|-0.33||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.33|0.9469
70916868|NCT00430300|141324312|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.09||0.9153|ONE_SIDED|95.0|-0.27||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.27|0.9153
70916869|NCT00430300|141324312|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.9686|ONE_SIDED|95.0|-0.36||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.36|0.9686
70916870|NCT00430300|141324312|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1548|ONE_SIDED|95.0|-0.06||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.06|0.1548
70916871|NCT00430300|141324312|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.09||0.7973|ONE_SIDED|95.0|-0.22||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.22|0.7973
70916872|NCT00430300|141324312|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.11||0.6348|ONE_SIDED|95.0|-0.22||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.22|0.6348
70916873|NCT00430300|141324312|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.1||0.5742|ONE_SIDED|95.0|-0.19||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.19|0.5742
70916874|NCT00430300|141324312|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.09||0.6719|ONE_SIDED|95.0|-0.19||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.19|0.6719
70916875|NCT00430300|141324312|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.13||0.0881|ONE_SIDED|95.0|-0.04||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.04|0.0881
70916876|NCT00430300|141324312|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.12||0.2772|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.2772
70916877|NCT00430300|141324312|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.11||0.1363|ONE_SIDED|95.0|-0.06||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.06|0.1363
70916878|NCT00430300|141324313|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.1||0.0938|ONE_SIDED|95.0|-0.03||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.03|0.0938
70916879|NCT00430300|141324313|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.1||0.2149|ONE_SIDED|95.0|-0.09||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.09|0.2149
70916880|NCT00430300|141324313|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.09||0.1682|ONE_SIDED|95.0|-0.06||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.06|0.1682
70916881|NCT00430300|141324313|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.1||0.4492|ONE_SIDED|95.0|-0.16||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.16|0.4492
70916882|NCT00430300|141324313|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.1||0.2539|ONE_SIDED|95.0|-0.1||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.10|0.2539
70916883|NCT00430300|141324313|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.09||0.8168|ONE_SIDED|95.0|-0.22||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.22|0.8168
70970749|NCT01964352|141447197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.017|STANDARD_ERROR_OF_MEAN|0.019||0.3872|TWO_SIDED|95.0|-0.021|0.054|||Mixed Effects Model for Repeated Measure|||||0.054|-0.021|0.3872
71093077|NCT02903914|141693254|OTHER||pairwise GMR|1.127|||||TWO_SIDED|90.0|0.947|1.341||||||||1.341|0.947|
71093078|NCT02903914|141693254|OTHER||pairwise GMR|0.991|||||TWO_SIDED|90.0|0.833|1.18||||||||1.180|0.833|
71093079|NCT02903914|141693254|OTHER||pairwise GMR|1.258|||||TWO_SIDED|90.0|1.064|1.486||||||||1.486|1.064|
71093080|NCT02903914|141693255|OTHER|||||||0.0518|||||||Kruskal-Wallis|||||||0.0518
71093081|NCT02903914|141693256|OTHER|||||||0.1723|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.1723
71093082|NCT02903914|141693256|OTHER||pairwise GMR|1.156|||||TWO_SIDED|90.0|0.941|1.42||||||||1.420|0.941|
71093083|NCT02903914|141693256|OTHER||pairwise GMR|0.976|||||TWO_SIDED|90.0|0.794|1.198||||||||1.198|0.794|
70916884|NCT00430300|141324313|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.3248|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.3248
70916885|NCT00430300|141324313|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.3148|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.3148
70916886|NCT00430300|141324313|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.09||0.6563|ONE_SIDED|95.0|-0.2||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.20|0.6563
70916887|NCT00430300|141324313|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.12||0.1735|ONE_SIDED|95.0|-0.09||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.09|0.1735
70916888|NCT00430300|141324313|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.12||0.1237|ONE_SIDED|95.0|-0.06||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.06|0.1237
70916889|NCT00430300|141324313|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.11||0.6113|ONE_SIDED|95.0|-0.21||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.21|0.6113
70916890|NCT00430300|141324314|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.5549|ONE_SIDED|95.0|-0.09||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.09|0.5549
70916891|NCT00430300|141324314|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.05||0.988|ONE_SIDED|95.0|-0.2||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.20|0.9880
70916892|NCT00430300|141324314|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.8572|ONE_SIDED|95.0|-0.12||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.12|0.8572
70916893|NCT00430300|141324314|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.8402|ONE_SIDED|95.0|-0.14||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.14|0.8402
70916894|NCT00430300|141324314|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.6562|ONE_SIDED|95.0|-0.1||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.10|0.6562
70916895|NCT00430300|141324314|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.5632|ONE_SIDED|95.0|-0.08||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.08|0.5632
70916896|NCT00430300|141324314|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.637|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.6370
70916897|NCT00430300|141324314|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.4686|ONE_SIDED|95.0|-0.1||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.10|0.4686
70916898|NCT00430300|141324314|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.06||0.6164|ONE_SIDED|95.0|-0.11||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.11|0.6164
70916899|NCT00430300|141324322|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.6||0.9885|ONE_SIDED|95.0|-2.4||||Mixed Models Analysis|||TDI at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-2.4|0.9885
70916900|NCT00430300|141324322|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.6||0.8055|ONE_SIDED|95.0|-1.5||||Mixed Models Analysis|||TDI at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.5|0.8055
70916901|NCT00430300|141324322|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.5||0.9759|ONE_SIDED|95.0|-2.0||||Mixed Models Analysis|||TDI at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-2.0|0.9759
70916902|NCT00430300|141324322|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.7||0.4401|ONE_SIDED|95.0|-1.1||||Mixed Models Analysis|||TDI at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.1|0.4401
70916903|NCT00430300|141324322|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.7||0.5957|ONE_SIDED|95.0|-1.4||||Mixed Models Analysis|||TDI at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.4|0.5957
70916904|NCT00430300|141324322|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.6||0.8302|ONE_SIDED|95.0|-1.7||||Mixed Models Analysis|||TDI at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.7|0.8302
70916905|NCT00430300|141324322|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.9||0.9657|ONE_SIDED|95.0|-3.1||||Mixed Models Analysis|||TDI at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-3.1|0.9657
70916906|NCT00430300|141324322|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.9||0.6378|ONE_SIDED|95.0|-1.7||||Mixed Models Analysis|||TDI at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.7|0.6378
70916907|NCT00430300|141324322|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.8||0.899|ONE_SIDED|95.0|-2.2||||Mixed Models Analysis|||TDI at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-2.2|0.8990
70916908|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.15||0.8757|ONE_SIDED|95.0|-0.42||||Mixed Models Analysis|||Cough, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.42|0.8757
70916909|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.15||0.6334|ONE_SIDED|95.0|-0.3||||Mixed Models Analysis|||Cough, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.30|0.6334
70916910|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.13||0.5448|ONE_SIDED|95.0|-0.23||||Mixed Models Analysis|||Cough, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.23|0.5448
70916911|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.16||0.6986|ONE_SIDED|95.0|-0.34||||Mixed Models Analysis|||Cough, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.34|0.6986
70916912|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.16||0.3151|ONE_SIDED|95.0|-0.18||||Mixed Models Analysis|||Cough, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.18|0.3151
70916913|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.14||0.1802|ONE_SIDED|95.0|-0.1||||Mixed Models Analysis|||Cough, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.10|0.1802
71093084|NCT02903914|141693256|OTHER||pairwise GMR|1.233|||||TWO_SIDED|90.0|1.012|1.503||||||||1.503|1.012|
70916914|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.16||0.9102|ONE_SIDED|95.0|-0.49||||Mixed Models Analysis|||Cough, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.49|0.9102
70916915|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.16||0.6391|ONE_SIDED|95.0|-0.32||||Mixed Models Analysis|||Cough, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.32|0.6391
70916916|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.6838|ONE_SIDED|95.0|-0.3||||Mixed Models Analysis|||Cough, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.30|0.6838
70916917|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.14||0.9648|ONE_SIDED|95.0|-0.49||||Mixed Models Analysis|||Cough, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.49|0.9648
70916918|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.8961|ONE_SIDED|95.0|-0.4||||Mixed Models Analysis|||Cough, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.40|0.8961
70916919|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.12||0.9534|ONE_SIDED|95.0|-0.41||||Mixed Models Analysis|||Cough, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.41|0.9534
70916920|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.18||0.7726|ONE_SIDED|95.0|-0.45||||Mixed Models Analysis|||Cough, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.45|0.7726
70916921|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.18||0.5665|ONE_SIDED|95.0|-0.33||||Mixed Models Analysis|||Cough, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.33|0.5665
71093085|NCT02903914|141693257|OTHER|||||||0.1705|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.1705
71093086|NCT02903914|141693257|OTHER||pairwise GMR|1.083|||||TWO_SIDED|90.0|0.863|1.359||||||||1.359|0.863|
71093087|NCT02903914|141693257|OTHER||pairwise GMR|0.902|||||TWO_SIDED|90.0|0.719|1.132||||||||1.132|0.719|
71093088|NCT02903914|141693257|OTHER||pairwise GMR|1.212|||||TWO_SIDED|90.0|0.945|1.554||||||||1.554|0.945|
70916922|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.16||0.2684|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Cough, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.2684
70916923|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.19||0.6485|ONE_SIDED|95.0|-0.39||||Mixed Models Analysis|||Cough, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.39|0.6485
70916924|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.19||0.4821|ONE_SIDED|95.0|-0.3||||Mixed Models Analysis|||Cough, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.30|0.4821
70916925|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.16||0.2557|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Cough, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.2557
70916926|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.17||0.9031|ONE_SIDED|95.0|-0.52||||Mixed Models Analysis|||Cough, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.52|0.9031
70916927|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.17||0.8634|ONE_SIDED|95.0|-0.47||||Mixed Models Analysis|||Cough, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.47|0.8634
70916928|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.15||0.6375|ONE_SIDED|95.0|-0.3||||Mixed Models Analysis|||Cough, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.30|0.6375
70916929|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.18||0.8775|ONE_SIDED|95.0|-0.51||||Mixed Models Analysis|||Cough, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.51|0.8775
70916930|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.7191|ONE_SIDED|95.0|-0.4||||Mixed Models Analysis|||Cough, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.40|0.7191
70916931|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.16||0.8677|ONE_SIDED|95.0|-0.44||||Mixed Models Analysis|||Cough, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.44|0.8677
70916932|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.11||0.9838|ONE_SIDED|95.0|-0.42||||Mixed Models Analysis|||Breathlessness, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.42|0.9838
70916933|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.8106|ONE_SIDED|95.0|-0.28||||Mixed Models Analysis|||Breathlessness, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.28|0.8106
70916934|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.1||0.775|ONE_SIDED|95.0|-0.23||||Mixed Models Analysis|||Breathlessness, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.23|0.7750
70916935|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.8082|ONE_SIDED|95.0|-0.33||||Mixed Models Analysis|||Breathlessness, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.33|0.8082
70916936|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.13||0.7678|ONE_SIDED|95.0|-0.31||||Mixed Models Analysis|||Breathlessness, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.31|0.7678
70916937|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.11||0.5373|ONE_SIDED|95.0|-0.2||||Mixed Models Analysis|||Breathlessness, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.20|0.5373
70916938|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.14||0.9548|ONE_SIDED|95.0|-0.47||||Mixed Models Analysis|||Breathlessness, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.47|0.9548
70916939|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.14||0.9743|ONE_SIDED|95.0|-0.49||||Mixed Models Analysis|||Breathlessness, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.49|0.9743
71093089|NCT02903914|141693261|OTHER||pairwise GMR|1.057||||0.7702|TWO_SIDED|90.0|0.753|1.483|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.483|0.753|0.7702
71093090|NCT02903914|141693261|OTHER||pairwise GMR|1.012||||0.9384|TWO_SIDED|90.0|0.762|1.346|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.346|0.762|0.9384
70916940|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.12||0.8408|ONE_SIDED|95.0|-0.32||||Mixed Models Analysis|||Breathlessness, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.32|0.8408
70916941|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.14||0.9887|ONE_SIDED|95.0|-0.55||||Mixed Models Analysis|||Breathlessness, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.55|0.9887
70916942|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.13||0.9918|ONE_SIDED|95.0|-0.55||||Mixed Models Analysis|||Breathlessness, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.55|0.9918
70916943|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.12||0.9833|ONE_SIDED|95.0|-0.46||||Mixed Models Analysis|||Breathlessness, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.46|0.9833
70916944|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.14||0.9619|ONE_SIDED|95.0|-0.5||||Mixed Models Analysis|||Breathlessness, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.50|0.9619
70916945|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.14||0.9917|ONE_SIDED|95.0|-0.58||||Mixed Models Analysis|||Breathlessness, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.58|0.9917
70916946|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.12||0.9376|ONE_SIDED|95.0|-0.4||||Mixed Models Analysis|||Breathlessness, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.40|0.9376
70916947|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.16||0.9084|ONE_SIDED|95.0|-0.47||||Mixed Models Analysis|||Breathlessness, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.47|0.9084
70916948|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.15||0.7906|ONE_SIDED|95.0|-0.38||||Mixed Models Analysis|||Breathlessness, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.38|0.7906
70916949|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.14||0.8765|ONE_SIDED|95.0|-0.38||||Mixed Models Analysis|||Breathlessness, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.38|0.8765
70916950|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.14||0.8469|ONE_SIDED|95.0|-0.38||||Mixed Models Analysis|||Breathlessness, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.38|0.8469
70916951|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.14||0.9717|ONE_SIDED|95.0|-0.5||||Mixed Models Analysis|||Breathlessness, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.50|0.9717
70916952|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.12||0.7591|ONE_SIDED|95.0|-0.29||||Mixed Models Analysis|||Breathlessness, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.29|0.7591
70916953|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.7141|ONE_SIDED|95.0|-0.38||||Mixed Models Analysis|||Breathlessness, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.38|0.7141
70916954|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.17||0.8104|ONE_SIDED|95.0|-0.42||||Mixed Models Analysis|||Breathlessness, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.42|0.8104
70916955|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.15||0.7664|ONE_SIDED|95.0|-0.35||||Mixed Models Analysis|||Breathlessness, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.35|0.7664
70916956|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.7888|ONE_SIDED|95.0|-0.31||||Mixed Models Analysis|||Sputum, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.31|0.7888
70916957|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.12||0.393|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Sputum, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.3930
70916958|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.11||0.4785|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Sputum, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.4785
71093091|NCT02903914|141693261|OTHER||pairwise GMR|1.07||||0.6733|TWO_SIDED|90.0|0.809|1.415|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.415|0.809|0.6733
70916959|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.16||0.6756|ONE_SIDED|95.0|-0.34||||Mixed Models Analysis|||Sputum, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.34|0.6756
70916960|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.16||0.2627|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Sputum, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.2627
70916961|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.14||0.2281|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Sputum, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.2281
70916962|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.16||0.7656|ONE_SIDED|95.0|-0.38||||Mixed Models Analysis|||Sputum, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.38|0.7656
70916963|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.16||0.2105|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Sputum, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.2105
70916964|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.14||0.2221|ONE_SIDED|95.0|-0.12||||Mixed Models Analysis|||Sputum, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.12|0.2221
70916965|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.16||0.4396|ONE_SIDED|95.0|-0.23||||Mixed Models Analysis|||Sputum, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.23|0.4396
70916966|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.15||0.2243|ONE_SIDED|95.0|-0.14||||Mixed Models Analysis|||Sputum, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.14|0.2243
70916967|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.13||0.3597|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Sputum, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.3597
70916968|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.14||0.203|ONE_SIDED|95.0|-0.12||||Mixed Models Analysis|||Sputum, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.12|0.2030
70916969|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.14||0.1207|ONE_SIDED|95.0|-0.07||||Mixed Models Analysis|||Sputum, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.07|0.1207
70916970|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.12||0.1836|ONE_SIDED|95.0|-0.09||||Mixed Models Analysis|||Sputum, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.09|0.1836
70916971|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.17||0.2359|ONE_SIDED|95.0|-0.16||||Mixed Models Analysis|||Sputum, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.16|0.2359
70916972|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.17||0.2861|ONE_SIDED|95.0|-0.18||||Mixed Models Analysis|||Sputum, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.18|0.2861
70916973|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.15||0.2151|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Sputum, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.2151
70916974|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.3545|ONE_SIDED|95.0|-0.21||||Mixed Models Analysis|||Sputum, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.21|0.3545
70916975|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.16||0.7102|ONE_SIDED|95.0|-0.35||||Mixed Models Analysis|||Sputum, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.35|0.7102
71093092|NCT02903914|141693261|OTHER||pairwise GMR|1.238||||0.3456|TWO_SIDED|90.0|0.83|1.847|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.847|0.830|0.3456
71093093|NCT02903914|141693262|OTHER|||||||0.0441|||||||Wilcoxon (Mann-Whitney)|||Fed versus Fasted||||0.0441
71093094|NCT02903914|141693262|OTHER|||||||0.4092|||||||Wilcoxon (Mann-Whitney)|||Fed versus Fasted||||0.4092
71093095|NCT02903914|141693262|OTHER|||||||0.7748|||||||Wilcoxon (Mann-Whitney)|||Fed versus Fasted||||0.7748
71093096|NCT02903914|141693262|OTHER|||||||0.1948|||||||Wilcoxon (Mann-Whitney)|||Fed versus Fasted||||0.1948
70916976|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.14||0.3883|ONE_SIDED|95.0|-0.19||||Mixed Models Analysis|||Sputum, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.19|0.3883
70916977|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.16||0.2228|ONE_SIDED|95.0|-0.14||||Mixed Models Analysis|||Sputum, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.14|0.2228
70916978|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.16||0.6342|ONE_SIDED|95.0|-0.32||||Mixed Models Analysis|||Sputum, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.32|0.6342
70916979|NCT00430300|141324323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.14||0.3141|ONE_SIDED|95.0|-0.16||||Mixed Models Analysis|||Sputum, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.16|0.3141
70916980|NCT00430300|141324324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.27||0.27|ONE_SIDED|95.0|-0.28||||Mixed Models Analysis|||Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.28|0.2700
70916981|NCT00430300|141324324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.26||0.1831|ONE_SIDED|95.0|-0.2||||Mixed Models Analysis|||Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.20|0.1831
70916982|NCT00430300|141324324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.23||0.1796|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.1796
70916983|NCT00430300|141324324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.31||0.8136|ONE_SIDED|95.0|-0.79||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.79|0.8136
70916984|NCT00430300|141324324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.3||0.6877|ONE_SIDED|95.0|-0.66||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.66|0.6877
70916985|NCT00430300|141324324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.27||0.6382|ONE_SIDED|95.0|-0.54||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.54|0.6382
70916986|NCT00430300|141324324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.36||0.766|ONE_SIDED|95.0|-0.87||||Mixed Models Analysis|||Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.87|0.7660
70916987|NCT00430300|141324324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.35||0.7226|ONE_SIDED|95.0|-0.8||||Mixed Models Analysis|||Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.80|0.7226
70916988|NCT00430300|141324324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.31||0.6634|ONE_SIDED|95.0|-0.65||||Mixed Models Analysis|||Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.65|0.6634
70916989|NCT00430300|141324324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.35||0.7598|ONE_SIDED|95.0|-0.83||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.83|0.7598
70916990|NCT00430300|141324324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.34||0.53|ONE_SIDED|95.0|-0.59||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.59|0.5300
70916991|NCT00430300|141324324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.3||0.7054|ONE_SIDED|95.0|-0.66||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.66|0.7054
70916992|NCT00430300|141324324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.45||0.8851|ONE_SIDED|95.0|-1.3||||Mixed Models Analysis|||Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.30|0.8851
70916993|NCT00430300|141324324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.44||0.7575|ONE_SIDED|95.0|-1.05||||Mixed Models Analysis|||Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.05|0.7575
70916994|NCT00430300|141324324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.39||0.4325|ONE_SIDED|95.0|-0.58||||Mixed Models Analysis|||Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.58|0.4325
70916995|NCT00430300|141324324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.48||0.8934|ONE_SIDED|95.0|-1.41||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.41|0.8934
70916996|NCT00430300|141324324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.47||0.5283|ONE_SIDED|95.0|-0.82||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.82|0.5283
70916997|NCT00430300|141324324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.41||0.49|ONE_SIDED|95.0|-0.68||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.68|0.4900
70916998|NCT00430300|141324324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.51||0.7465|ONE_SIDED|95.0|-1.2||||Mixed Models Analysis|||Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.20|0.7465
70916999|NCT00430300|141324324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.51||0.5848|ONE_SIDED|95.0|-0.95||||Mixed Models Analysis|||Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.95|0.5848
70917000|NCT00430300|141324324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.44||0.3178|ONE_SIDED|95.0|-0.53||||Mixed Models Analysis|||Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.53|0.3178
70917001|NCT00430300|141324324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.52||0.8169|ONE_SIDED|95.0|-1.34||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.34|0.8169
70917002|NCT00430300|141324324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.51||0.6727|ONE_SIDED|95.0|-1.08||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.08|0.6727
70917003|NCT00430300|141324324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.45||0.5014|ONE_SIDED|95.0|-0.75||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.75|0.5014
70917004|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|6.3||0.7292|ONE_SIDED|95.0|-14.3||||Mixed Models Analysis|||Morning PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-14.3|0.7292
70917005|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|6.2||0.2768|ONE_SIDED|95.0|-6.6||||Mixed Models Analysis|||Morning PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-6.6|0.2768
71093097|NCT02903914|141693263|OTHER||pairwise GMR|0.92||||0.705|TWO_SIDED|90.0|0.62|1.363|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.363|0.620|0.7050
71093098|NCT02903914|141693263|OTHER||pairwise GMR|0.929||||0.703|TWO_SIDED|90.0|0.658|1.31|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.310|0.658|0.7030
71093099|NCT02903914|141693263|OTHER||pairwise GMR|0.999||||0.9952|TWO_SIDED|90.0|0.725|1.377|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.377|0.725|0.9952
71093100|NCT02903914|141693263|OTHER||pairwise GMR|0.742||||0.4012|TWO_SIDED|90.0|0.394|1.397|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.397|0.394|0.4012
70917006|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|5.4||0.3795|ONE_SIDED|95.0|-7.4||||Mixed Models Analysis|||Morning PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-7.4|0.3795
70917007|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|7.7||0.7374|ONE_SIDED|95.0|-17.7||||Mixed Models Analysis|||Morning PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-17.7|0.7374
70917008|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.4|STANDARD_ERROR_OF_MEAN|7.6||0.7615|ONE_SIDED|95.0|-18.1||||Mixed Models Analysis|||Morning PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-18.1|0.7615
70917009|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|6.6||0.5811|ONE_SIDED|95.0|-12.4||||Mixed Models Analysis|||Morning PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-12.4|0.5811
70917010|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-10.9|STANDARD_ERROR_OF_MEAN|8.6||0.8939|ONE_SIDED|95.0|-25.3||||Mixed Models Analysis|||Morning PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-25.3|0.8939
71093101|NCT02903914|141693264|OTHER||pairwise GMR|0.992||||0.9623|TWO_SIDED|90.0|0.729|1.349|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = formulation)||Tablet (test) versus Capsule (reference)||1.349|0.729|0.9623
71093102|NCT02903914|141693265|OTHER|||||||0.754|||||||Wilcoxon (Mann-Whitney)|||Tablet (test) versus Capsule (reference)||||0.7540
71093103|NCT02903914|141693266|OTHER||pairwise GMR|0.951||||0.7514|TWO_SIDED|90.0|0.718|1.261|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||Tablet (test) versus Capsule (reference)||1.261|0.718|0.7514
71093104|NCT02903914|141693267|OTHER||pairwise GMR|0.954||||0.7707|TWO_SIDED|90.0|0.712|1.277|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = formulation)||Tablet (test) versus Capsule (reference)||1.277|0.712|0.7707
70917011|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|8.4||0.8117|ONE_SIDED|95.0|-21.6||||Mixed Models Analysis|||Morning PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-21.6|0.8117
70917012|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|7.4||0.4393|ONE_SIDED|95.0|-11.2||||Mixed Models Analysis|||Morning PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-11.2|0.4393
70917013|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.5|STANDARD_ERROR_OF_MEAN|9.8||0.8055|ONE_SIDED|95.0|-24.7||||Mixed Models Analysis|||Morning PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-24.7|0.8055
70917014|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|9.5||0.6767|ONE_SIDED|95.0|-20.2||||Mixed Models Analysis|||Morning PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-20.2|0.6767
70917015|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|8.4||0.407|ONE_SIDED|95.0|-12.0||||Mixed Models Analysis|||Morning PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-12.0|0.4070
70917016|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-18.6|STANDARD_ERROR_OF_MEAN|9.7||0.9705|ONE_SIDED|95.0|-34.7||||Mixed Models Analysis|||Morning PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-34.7|0.9705
70917017|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.9|STANDARD_ERROR_OF_MEAN|9.4||0.8249|ONE_SIDED|95.0|-24.6||||Mixed Models Analysis|||Morning PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-24.6|0.8249
70917018|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-12.7|STANDARD_ERROR_OF_MEAN|8.3||0.9345|ONE_SIDED|95.0|-26.6||||Mixed Models Analysis|||Morning PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-26.6|0.9345
70917019|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|11.0||0.7384|ONE_SIDED|95.0|-25.3||||Mixed Models Analysis|||Morning PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-25.3|0.7384
70917020|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|10.7||0.5239|ONE_SIDED|95.0|-18.4||||Mixed Models Analysis|||Morning PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-18.4|0.5239
70917021|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|9.4||0.417|ONE_SIDED|95.0|-13.7||||Mixed Models Analysis|||Morning PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-13.7|0.4170
70917022|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|10.3||0.7695|ONE_SIDED|95.0|-24.8||||Mixed Models Analysis|||Morning PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-24.8|0.7695
70917023|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|10.1||0.4566|ONE_SIDED|95.0|-15.6||||Mixed Models Analysis|||Morning PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-15.6|0.4566
70917024|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|8.9||0.3535|ONE_SIDED|95.0|-11.4||||Mixed Models Analysis|||Morning PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-11.4|0.3535
70917025|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-12.1|STANDARD_ERROR_OF_MEAN|11.1||0.8598|ONE_SIDED|95.0|-30.7||||Mixed Models Analysis|||Morning PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-30.7|0.8598
70917026|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-9.2|STANDARD_ERROR_OF_MEAN|10.9||0.8005|ONE_SIDED|95.0|-27.4||||Mixed Models Analysis|||Morning PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-27.4|0.8005
70917027|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|9.6||0.3441|ONE_SIDED|95.0|-12.2||||Mixed Models Analysis|||Morning PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-12.2|0.3441
70917028|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|6.9||0.4436|ONE_SIDED|95.0|-10.5||||Mixed Models Analysis|||Evening PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-10.5|0.4436
70917029|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|6.8||0.7238|ONE_SIDED|95.0|-15.5||||Mixed Models Analysis|||Evening PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-15.5|0.7238
71093105|NCT04725188|141693273|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.091|TWO_SIDED|95.0|0.53|1.13|||Regression, Cox|||||1.13|0.53|0.0910
70917030|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|6.0||0.5743|ONE_SIDED|95.0|-11.1||||Mixed Models Analysis|||Evening PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-11.1|0.5743
70917031|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|9.8||0.619|ONE_SIDED|95.0|-19.3||||Mixed Models Analysis|||Evening PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-19.3|0.6190
70917032|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-15.9|STANDARD_ERROR_OF_MEAN|9.7||0.9473|ONE_SIDED|95.0|-32.1||||Mixed Models Analysis|||Evening PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-32.1|0.9473
70917033|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.3|STANDARD_ERROR_OF_MEAN|8.5||0.8014|ONE_SIDED|95.0|-21.4||||Mixed Models Analysis|||Evening PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-21.4|0.8014
70917034|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.1|STANDARD_ERROR_OF_MEAN|8.6||0.7929|ONE_SIDED|95.0|-21.5||||Mixed Models Analysis|||Evening PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-21.5|0.7929
70917035|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-23.2|STANDARD_ERROR_OF_MEAN|8.4||0.9963|ONE_SIDED|95.0|-37.3||||Mixed Models Analysis|||Evening PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-37.3|0.9963
70917036|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|7.4||0.7387|ONE_SIDED|95.0|-17.1||||Mixed Models Analysis|||Evening PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-17.1|0.7387
70917037|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|8.4||0.6286|ONE_SIDED|95.0|-16.8||||Mixed Models Analysis|||Evening PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-16.8|0.6286
70917038|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-14.1|STANDARD_ERROR_OF_MEAN|8.3||0.9538|ONE_SIDED|95.0|-27.8||||Mixed Models Analysis|||Evening PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-27.8|0.9538
70917039|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|7.3||0.5701|ONE_SIDED|95.0|-13.4||||Mixed Models Analysis|||Evening PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-13.4|0.5701
70917040|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-14.5|STANDARD_ERROR_OF_MEAN|10.0||0.9242|ONE_SIDED|95.0|-31.3||||Mixed Models Analysis|||Evening PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-31.3|0.9242
71093106|NCT04725188|141693273|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.9622|TWO_SIDED|95.0|0.96|2.02|||Regression, Cox|||||2.02|0.96|0.9622
71093107|NCT04725188|141693274|SUPERIORITY||Difference in percentage|14.7||||0.0113|TWO_SIDED|95.0|2.1|26.9|||Miettinen & Nurminen method|||||26.9|2.1|0.0113
71093108|NCT04725188|141693274|SUPERIORITY||Difference in percentage|-9.4||||0.975|TWO_SIDED|95.0|-19.6|0.0|||Miettinen & Nurminen method|||||0.0|-19.6|0.9750
70917041|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-22.4|STANDARD_ERROR_OF_MEAN|9.8||0.9876|ONE_SIDED|95.0|-38.8||||Mixed Models Analysis|||Evening PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-38.8|0.9876
70917042|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-18.1|STANDARD_ERROR_OF_MEAN|8.7||0.9802|ONE_SIDED|95.0|-32.5||||Mixed Models Analysis|||Evening PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-32.5|0.9802
70917043|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|10.6||0.5705|ONE_SIDED|95.0|-19.5||||Mixed Models Analysis|||Evening PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-19.5|0.5705
70917044|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|10.3||0.8063|ONE_SIDED|95.0|-26.1||||Mixed Models Analysis|||Evening PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-26.1|0.8063
70917045|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|9.1||0.6667|ONE_SIDED|95.0|-19.1||||Mixed Models Analysis|||Evening PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-19.1|0.6667
71093109|NCT04725188|141693275|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0943|TWO_SIDED|95.0|0.5|1.15|||Regression, Cox|||||1.15|0.50|0.0943
71093110|NCT04725188|141693275|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.5974|TWO_SIDED|95.0|0.7|1.58|||Regression, Cox|||||1.58|0.70|0.5974
71093111|NCT02320175|141693343|OTHER|We compared percent top-box experience ratings pre- vs. post-intervention using a GEE chi-squared test for binary outcomes, clustered by site. Top-box score was calculated as the percentage of participants that gave the top-most response for the given survey item (e.g., 5=Extremely; 5=Excellent). Missing data was accounted for through use of multiple imputations appropriate for missing data in clustered studies.|||||<|0.05|||||||GEE chi-squared test for binary outcomes|||||||<.05
71093112|NCT03116230|141693382|OTHER|||||||0.005|||||||t-test, 2 sided|Treatment A vs Control||||||0.005
70917046|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|10.4||0.464|ONE_SIDED|95.0|-16.4||||Mixed Models Analysis|||Evening PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-16.4|0.4640
70917047|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-12.2|STANDARD_ERROR_OF_MEAN|10.2||0.8821|ONE_SIDED|95.0|-29.3||||Mixed Models Analysis|||Evening PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-29.3|0.8821
70917048|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|9.0||0.7591|ONE_SIDED|95.0|-21.4||||Mixed Models Analysis|||Evening PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-21.4|0.7591
70917049|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|11.0||0.4001|ONE_SIDED|95.0|-15.6||||Mixed Models Analysis|||Evening PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-15.6|0.4001
70917050|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-12.3|STANDARD_ERROR_OF_MEAN|10.8||0.8707|ONE_SIDED|95.0|-30.3||||Mixed Models Analysis|||Evening PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-30.3|0.8707
70917051|NCT00430300|141324325|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|9.6||0.4629|ONE_SIDED|95.0|-15.0||||Mixed Models Analysis|||Evening PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-15.0|0.4629
70917052|NCT00430300|141324326|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6428|||||TWO_SIDED|95.0|0.2023|2.0419||||||A proportional odds model was fitted using Proc Logistic in Statistical Analysis System (SAS), using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.||2.0419|0.2023|
70917053|NCT00430300|141324326|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5574|||||TWO_SIDED|95.0|0.1505|2.0647||||||A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.||2.0647|0.1505|
70917054|NCT00430300|141324326|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.327|||||TWO_SIDED|95.0|0.083|1.2879||||||A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.||1.2879|0.0830|
70917055|NCT00430300|141324327|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5709|||||TWO_SIDED|95.0|0.179|1.8204||||||A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.||1.8204|0.1790|
70917056|NCT00430300|141324327|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6416|||||TWO_SIDED|95.0|0.1736|2.3715||||||A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.||2.3715|0.1736|
70917057|NCT00430300|141324327|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5877|||||TWO_SIDED|95.0|0.1516|2.2777||||||A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.||2.2777|0.1516|
70917058|NCT00546871|141324361|SUPERIORITY_OR_OTHER_LEGACY||Poisson|0.067|||||ONE_SIDED|99.0||0.134||||||||0.134||
70917059|NCT01359371|141324409|SUPERIORITY||||||<|0.01|||||||Fisher Exact|||Bivariate relationships between a patient's participation in the program and smoking status were calculated.||||<.01
70917060|NCT01359371|141324410|OTHER|T-tests, chi squares and Fishers exact tests were used to compare groups.|||||<|0.05||||||This was just a sample description, so there was not adjustment for multiple comparisons.|Chi-squared||||T-tests, chi squares and Fishers exact tests were used to compare groups.|||<.05
70917061|NCT01359371|141324410|OTHER||||||<|0.05|||||||Chi-squared|||T-tests, chi squares and Fishers exact tests were used to compare groups.||||<.05
70917062|NCT04541303|141324435|SUPERIORITY|||||||0.028|||||||None specified|||||||.028
70917063|NCT03538041|141324453|SUPERIORITY|||||||0.2815|||||||ANOVA|||Week 2||||0.2815
70917064|NCT03538041|141324454|SUPERIORITY|||||||0.2921|||||||Kruskal-Wallis|||Week 2||||0.2921
70917065|NCT03538041|141324455|SUPERIORITY|||||||0.1267|||||||ANOVA|||Week 2||||0.1267
70917066|NCT03538041|141324456|SUPERIORITY|||||||0.2676|||||||ANOVA|||Week 2||||0.2676
70917067|NCT00807144|141324476|SUPERIORITY|||||||0.26|||||||Log Rank|||||||0.26
70917068|NCT00807144|141324477|SUPERIORITY|||||||0.48|||||||Log Rank|||Year 1||||0.48
70917069|NCT00807144|141324477|SUPERIORITY|||||||0.75|||||||Log Rank|||Year 2||||0.75
70917070|NCT00854906|141324561|NON_INFERIORITY_OR_EQUIVALENCE|This was a pilot study. Therefore, no formal power analyses were performed.|Mean Difference (Final Values)|0.666|STANDARD_DEVIATION|3.6||0.074|TWO_SIDED|95.0|-0.069|1.401|||t-test, 2 sided|||The paired T-test was used to compare mean KTBUT and mean FTBUT.||1.401|-0.069|0.074
70917071|NCT00854906|141324562|NON_INFERIORITY_OR_EQUIVALENCE|The analysis will evaluate the association between OSDI with KTBUT.|Pearson's Correlation, r|-0.34||||0.093|ONE_SIDED||||||Pearson's correlation|||A correlation was performed between ODSI questionnaire results and each participant's KTBUT.||||0.093
70917072|NCT00854906|141324562|SUPERIORITY_OR_OTHER||Pearson's Correlation, r|-0.26||||0.216|||||||Pearson's Correlation|||A correlation was performed between ODSI questionnaire results and each participant's FTBUT.||||0.216
71093113|NCT03116230|141693382|OTHER|||||||0.64|||||||t-test, 2 sided|Treatment B vs Control||||||0.64
71093114|NCT01933932|141693386|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.4355|TWO_SIDED|95.0|0.77|1.12|||Log Rank|Analysis stratified by WHO performance status at randomisation.||||1.12|0.77|0.4355
70917073|NCT03034915|141324634|OTHER||Mean Difference (Net)|0.066|STANDARD_ERROR_OF_MEAN|0.0118|<|0.001|TWO_SIDED|95.0|0.043|0.089|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 24.|||0.089|0.043|<0.001
70917074|NCT03034915|141324634|OTHER||Mean Difference (Net)|0.141|STANDARD_ERROR_OF_MEAN|0.0117|<|0.001|TWO_SIDED|95.0|0.118|0.164|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 24.|||0.164|0.118|<0.001
70917075|NCT03034915|141324634|OTHER||Mean Difference (Net)|0.075|STANDARD_ERROR_OF_MEAN|0.0119|<|0.001|TWO_SIDED|95.0|0.051|0.098|||Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 24.|||0.098|0.051|<0.001
70917076|NCT03034915|141324635|OTHER||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|0.157||0.018|TWO_SIDED|95.0|0.06|0.68|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 24.|||0.68|0.06|0.018
70917077|NCT03034915|141324635|OTHER||Mean Difference (Net)|0.45|STANDARD_ERROR_OF_MEAN|0.155||0.004|TWO_SIDED|95.0|0.15|0.76|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 24.|||0.76|0.15|0.004
70917078|NCT03034915|141324635|OTHER||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.159||0.61|TWO_SIDED|95.0|-0.23|0.39|||Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 24|||0.39|-0.23|0.610
70917079|NCT03034915|141324636|OTHER||Odds Ratio (OR)|1.43|||<|0.001|TWO_SIDED|95.0|1.17|1.75|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI vs UMEC at Week 24|||1.75|1.17|<0.001
70917080|NCT03034915|141324636|OTHER||Odds Ratio (OR)|1.48|||<|0.001|TWO_SIDED|95.0|1.21|1.81|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus salmeterol at Week 24|||1.81|1.21|<0.001
70917081|NCT03034915|141324636|OTHER||Odds Ratio (OR)|1.03||||0.755|TWO_SIDED|95.0|0.84|1.27|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC versus salmeterol at Week 24.|||1.27|0.84|0.755
70917082|NCT03034915|141324637|OTHER||Mean Difference (Net)|-0.53|STANDARD_ERROR_OF_MEAN|0.213||0.013|TWO_SIDED|95.0|-0.95|-0.11|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 21 to Week 24|||-0.11|-0.95|0.013
70917083|NCT03034915|141324637|OTHER||Mean Difference (Net)|-0.83|STANDARD_ERROR_OF_MEAN|0.211|<|0.001|TWO_SIDED|95.0|-1.25|-0.42|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 21 to Week 24..|||-0.42|-1.25|<0.001
70917084|NCT03034915|141324637|OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.214||0.159|TWO_SIDED|95.0|-0.72|0.12|||Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 21 to Week 24|||0.12|-0.72|0.159
71093115|NCT01933932|141693387|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.05||||0.6431|TWO_SIDED|95.0|0.85|1.3|||Log Rank|Analysis stratified by WHO performance status at randomisation.||||1.30|0.85|0.6431
70917085|NCT03034915|141324638|OTHER||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.114||0.016|TWO_SIDED|95.0|-0.5|-0.05||E-RS Breathlessness Score|Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 21 to Week 24.|||-0.05|-0.50|0.016
70917086|NCT03034915|141324638|OTHER||Mean Difference (Net)|-0.46|STANDARD_ERROR_OF_MEAN|0.113|<|0.001|TWO_SIDED|95.0|-0.68|-0.23||E-RS Breathlessness Score|Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 21 to Week 24.|||-0.23|-0.68|<0.001
70917087|NCT03034915|141324638|OTHER||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|0.115||0.115|TWO_SIDED|95.0|-0.41|0.04||E-RS Breathlessness Score|Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 21 to Week 24.|||0.04|-0.41|0.115
70917088|NCT03034915|141324638|OTHER||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.063||0.247|TWO_SIDED|95.0|-0.2|0.05||E-RS Cough and Sputum Score|Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 21 to Week 24.|||0.05|-0.20|0.247
70917089|NCT03034915|141324638|OTHER||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.063||0.042|TWO_SIDED|95.0|-0.25|0.0||E-RS Cough and Sputum Score|Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 21 to Week 24.|||0.00|-0.25|0.042
70917090|NCT03034915|141324638|OTHER||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.063||0.391|TWO_SIDED|95.0|-0.18|0.07||E-RS Cough and Sputum Score|Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 21 to Week 24.|||0.07|-0.18|0.391
70917091|NCT03034915|141324638|OTHER||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.014|TWO_SIDED|95.0|-0.31|-0.04||E-RS Chest Symptoms Score|Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 21 to Week 24|||-0.04|-0.31|0.014
70917092|NCT03034915|141324638|OTHER||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.069|<|0.001|TWO_SIDED|95.0|-0.37|-0.1||E-RS Chest Symptoms Score|Mixed model repeated measures||LS Mean difference comapring UMEC/VI versus salmeterol at Week 21 to Week 24.|||-0.10|-0.37|<0.001
70917093|NCT03034915|141324638|OTHER||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.07||0.34|TWO_SIDED|95.0|-0.2|0.07||E-RS Chest Symptoms Score|Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 21 to Week 24.|||0.07|-0.20|0.340
70917094|NCT03034915|141324639|OTHER||Odds Ratio (OR)|1.52|||<|0.001|TWO_SIDED|95.0|1.22|1.89|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI vs UMEC at Week 21 to Week 24|||1.89|1.22|<0.001
70917095|NCT03034915|141324639|OTHER||Odds Ratio (OR)|1.53|||<|0.001|TWO_SIDED|95.0|1.23|1.9|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus salmeterol at Week 21 to Week 24.|||1.90|1.23|<0.001
70917096|NCT03034915|141324639|OTHER||Odds Ratio (OR)|1.0||||0.969|TWO_SIDED|95.0|0.8|1.26|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC versus salmeterol at Week 21 to Week 24.|||1.26|0.80|0.969
70917097|NCT03034915|141324640|OTHER||Mean Difference (Net)|0.25|STANDARD_ERROR_OF_MEAN|0.672||0.709|TWO_SIDED|95.0|-1.07|1.57|||mixed model repeated measure||LS Mean difference comparing UMEC/VI versus UMEC at Week 24.|||1.57|-1.07|0.709
70917098|NCT03034915|141324640|OTHER||Mean Difference (Net)|-1.69|STANDARD_ERROR_OF_MEAN|0.665||0.011|TWO_SIDED|95.0|-2.99|-0.39|||mixed model repeated measure||LS Mean difference comparing UMEC/VI versus salmeterol at Week 24.|||-0.39|-2.99|0.011
70970750|NCT01964352|141447197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.096|0.172|||Mixed Effects Model for Repeated Measure|||||0.172|0.096|<0.0001
71093116|NCT01933932|141693388|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.61||||0.0515|TWO_SIDED|95.0|1.0|2.62|||Regression, Logistic|Analysis stratified by WHO performance status at randomisation||||2.62|1.00|0.0515
71093117|NCT01933932|141693390|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17||||0.5007|TWO_SIDED|95.0|0.74|1.86|||Regression, Logistic|Analysis stratified by WHO performance status at randomisation||||1.86|0.74|0.5007
70917099|NCT03034915|141324640|OTHER||Mean Difference (Net)|-1.94|STANDARD_ERROR_OF_MEAN|0.678||0.004|TWO_SIDED|95.0|-3.27|-0.61|||mixed model repeated measure||LS Mean difference comparing UMEC versus salmeterol at Week 24.|||-0.61|-3.27|0.004
70917100|NCT03034915|141324641|OTHER||Odds Ratio (OR)|1.21||||0.063|TWO_SIDED|95.0|0.99|1.48|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus UMEC at Week 24.|||1.48|0.99|0.063
70917101|NCT03034915|141324641|OTHER||Odds Ratio (OR)|1.49|||<|0.001|TWO_SIDED|95.0|1.22|1.83|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus salmeterol at Week 24.|||1.83|1.22|<0.001
70917102|NCT03034915|141324641|OTHER||Odds Ratio (OR)|1.23||||0.045|TWO_SIDED|95.0|1.0|1.51|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC versus salmeterol at Week 24.|||1.51|1.00|0.045
70917103|NCT03034915|141324642|OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.891|TWO_SIDED|95.0|-0.6|0.6|||mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 24.|||0.6|-0.6|0.891
70917104|NCT03034915|141324642|OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.074|TWO_SIDED|95.0|-1.1|0.1|||mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 24.|||0.1|-1.1|0.074
70917105|NCT03034915|141324642|OTHER||Odds Ratio (OR)|-0.5|STANDARD_ERROR_OF_MEAN|0.31||0.107|TWO_SIDED|95.0|-1.1|0.1|||mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 24.|||0.1|-1.1|0.107
70917106|NCT03034915|141324643|OTHER||Odds Ratio (OR)|1.35||||0.003|TWO_SIDED|95.0|1.11|1.65|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus UMEC at Week 24.|||1.65|1.11|0.003
70917107|NCT03034915|141324643|OTHER||Odds Ratio (OR)|1.23||||0.037|TWO_SIDED|95.0|1.01|1.5|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus salmeterol at Week 24.|||1.50|1.01|0.037
70917108|NCT03034915|141324643|OTHER||Odds Ratio (OR)|0.91||||0.363|TWO_SIDED|95.0|0.75|1.11|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC versus salmeterol at Week 24.|||1.11|0.75|0.363
70917109|NCT03861767|141324645|SUPERIORITY||Odds Ratio (OR)|1.14|||||TWO_SIDED|95.0|0.67|1.97||||||Low dose groups collapsed and compared to placebo||1.97|0.67|
70917110|NCT03861767|141324645|SUPERIORITY||Odds Ratio (OR)|0.72|||||TWO_SIDED|95.0|0.42|1.25||||||Intermediate dose groups were collapsed and compared to placebo||1.25|0.42|
70917111|NCT03861767|141324645|SUPERIORITY||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.61|1.84||||||High dose groups were collapsed and compared to placebo||1.84|0.61|
70917112|NCT03861767|141324646|SUPERIORITY||Odds Ratio (OR)|1.03||||0.92|TWO_SIDED|95.0|0.52|2.03|||Regression, Logistic|||All intervention groups were grouped together and compared to placebo||2.03|0.52|0.92
70917113|NCT03861767|141324647|SUPERIORITY||Odds Ratio (OR)|1.08||||0.8|TWO_SIDED|95.0|0.52|2.0|||Regression, Logistic|||All intervention groups were grouped together and compared to placebo||2.00|0.52|0.80
70917114|NCT03861767|141324648|SUPERIORITY||Odds Ratio (OR)|1.23||||0.65|TWO_SIDED|95.0|0.49|3.11|||Regression, Logistic|||All intervention groups were grouped together and compared to placebo||3.11|0.49|0.65
70917115|NCT03861767|141324649|SUPERIORITY||Odds Ratio (OR)|1.62||||0.23|TWO_SIDED|95.0|0.73|3.62|||Regression, Logistic|||All intervention groups were grouped together and compared to placebo||3.62|0.73|0.23
70917116|NCT03861767|141324650|SUPERIORITY||Odds Ratio (OR)|1.42||||0.31|TWO_SIDED|95.0|0.71|2.86|||Regression, Logistic|||All intervention groups were grouped together and compared to placebo||2.86|0.71|0.31
70917117|NCT03861767|141324651|SUPERIORITY||Beta-coefficient|0.0011|STANDARD_ERROR_OF_MEAN|0.042||0.97|TWO_SIDED||||||Regression, Linear|||All intervention groups were grouped together and compared to placebo||||0.97
70917118|NCT03861767|141324652|SUPERIORITY||Beta-coefficient|-0.76|STANDARD_ERROR_OF_MEAN|0.74||0.3|TWO_SIDED||||||Regression, Linear|||All intervention groups were grouped together and compared to placebo||||0.30
71093118|NCT01933932|141693391|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.3438|TWO_SIDED|95.0|0.74|1.11|||Log Rank|Analysis stratified by WHO performance status at randomisation.||||1.11|0.74|0.3438
70917119|NCT03861767|141324653|SUPERIORITY||Beta-coefficient|0.27|STANDARD_ERROR_OF_MEAN|0.59||0.65|TWO_SIDED||||||Regression, Linear|||All intervention groups were grouped together and compared to placebo||||0.65
70917120|NCT03861767|141324655|SUPERIORITY||Odds Ratio (OR)|1.45||||0.27|TWO_SIDED|95.0|0.74|2.86|||Regression, Logistic|||||2.86|0.74|0.27
70917121|NCT03861767|141324656|SUPERIORITY||Odds Ratio (OR)|2.98||||0.01|TWO_SIDED|95.0|1.19|7.44|||Regression, Logistic|||All intervention groups were collapsed and compared to placebo||7.44|1.19|0.01
70917122|NCT03861767|141324657|SUPERIORITY||Odds Ratio (OR)|2.67|||<|0.01|TWO_SIDED|95.0|1.34|5.3|||Regression, Logistic|||All intervention groups were collapsed and compared to placebo||5.30|1.34|<0.01
70917123|NCT03861767|141324658|SUPERIORITY||Odds Ratio (OR)|0.9||||0.72|TWO_SIDED|95.0|0.52|1.56|||Regression, Logistic|||All intervention groups were collapsed into one group and compared with placebo. Patients were compared whether they were discharged home or other.||1.56|0.52|0.72
70917124|NCT01087762|141324660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.3|||=|0.004|TWO_SIDED|95.0|6.3|32.4||Difference of Certolizumab Pegol 200 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|Wald test and Confidence Interval (CI) calculation were performed without continuity correction.||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||32.4|6.3|=0.004
70970751|NCT01964352|141447197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.019||0.5333|TWO_SIDED|95.0|-0.025|0.049|||Mixed Effects Model for Repeated Measure|||||0.049|-0.025|0.5333
71093119|NCT04235374|141693425|SUPERIORITY||Mean Difference (Final Values)|0.06|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<.05
71093120|NCT04235374|141693426|SUPERIORITY||Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<.05
70917125|NCT01087762|141324660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.2|||<|0.001|TWO_SIDED|95.0|12.3|38.2||Difference of Certolizumab Pegol 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|Wald test and Confidence Interval (CI) calculation were performed without continuity correction.||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||38.2|12.3|<0.001
70917126|NCT01087762|141324661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.7|||<|0.001|TWO_SIDED|95.0|25.4|50.0||Difference of Certolizumab Pegol 200 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|Wald test and Confidence Interval (CI) calculation were performed without continuity correction.||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||50.0|25.4|<0.001
70917127|NCT01087762|141324661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.1|||<|0.001|TWO_SIDED|95.0|28.9|53.3||Difference of Certolizumab Pegol 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|Wald test and Confidence Interval (CI) calculation were performed without continuity correction.||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||53.3|28.9|<0.001
70917128|NCT01087762|141324662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.49|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.96|-1.01||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASFI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-1.01|-1.96|<0.001
70917129|NCT01087762|141324663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-2.38|-1.38||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASFI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-1.38|-2.38|<0.001
70917130|NCT01087762|141324664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.07|-1.12||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASDAI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-1.12|-2.07|<0.001
70917131|NCT01087762|141324665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-2.49|-1.5||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASDAI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-1.50|-2.49|<0.001
70917132|NCT01087762|141324666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.2||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASMI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-0.20|-0.60|<0.001
70970752|NCT01964352|141447198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.894|STANDARD_ERROR_OF_MEAN|1.024|<|0.0001|TWO_SIDED|95.0|-6.904|-2.884|||Mixed Effects Model for Repeated Measure|||||-2.884|-6.904|<0.0001
71093121|NCT04235374|141693427|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||.05
71153915|NCT00488683|141800065|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.07||||0.36||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup C||||0.36
71153916|NCT00488683|141800065|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.11||||0.18||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup W-135||||0.18
70917133|NCT01087762|141324667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.66|-0.23||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASMI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-0.23|-0.66|<0.001
70917134|NCT01188499|141324673|SUPERIORITY_OR_OTHER||Percent|100.0|||||TWO_SIDED||||||||Primary objective of safety and tolerability measured by percent participants experiencing at least one adverse event. No formal statistics performed.|||||
70917135|NCT01188499|141324674|SUPERIORITY_OR_OTHER||Percent|10.0|||||TWO_SIDED||||||||Percent patients overall across all five arms demonstrating complete or partial response by RECIST. No formal statistics performed.|||||
70917136|NCT00424762|141324676|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||powered to detect at least 33% difference between groups||||>0.05
70917137|NCT00424762|141324677|SUPERIORITY_OR_OTHER|||||||0.26|||||||t-test, 2 sided|||powered to detect difference of at least 10% between groups||||0.26
70917138|NCT00424762|141324678|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Chi-squared|||comparative incidence||||0.03
70917139|NCT02311972|141324679|SUPERIORITY|Mean axillary admission temperature||||||0.7294|||||||t-test, 2 sided|||||||0.7294
70917140|NCT02311972|141324680|SUPERIORITY|||||||0.236|||||||t-test, 2 sided|||||||0.2360
70917141|NCT02311972|141324681|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
70917142|NCT02311972|141324682|SUPERIORITY|||||||0.1089|||||||t-test, 2 sided|||||||0.1089
70970753|NCT01964352|141447198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.493|STANDARD_ERROR_OF_MEAN|1.009||0.0136|TWO_SIDED|95.0|-4.473|-0.513|||Mixed Effects Model for Repeated Measure|||||-0.513|-4.473|0.0136
71093122|NCT04235374|141693428|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||.05
70917143|NCT02311972|141324683|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
70917144|NCT02311972|141324684|SUPERIORITY|||||||0.4947|||||||t-test, 2 sided|||||||0.4947
70917145|NCT02311972|141324685|SUPERIORITY|Infant 007|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70917146|NCT02311972|141324685|SUPERIORITY|Infant 010|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70917147|NCT02311972|141324685|SUPERIORITY|Infant 015|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70917148|NCT02311972|141324685|SUPERIORITY|Infant 039|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70917149|NCT02311972|141324685|SUPERIORITY|Infant 040||||||0.3947|||||||t-test, 2 sided|||||||0.3947
70917150|NCT01391130|141324730|SUPERIORITY||Hazard Ratio (HR)|1.2149||||0.4318|TWO_SIDED|95.0|0.7462|1.9779|||Log Rank|||||1.9779|0.7462|0.4318
70917151|NCT03478696|141324735|NON_INFERIORITY|Non-inferiority was to be demonstrated, if the lower bound of the two-sided 95 percentage (%) confidence interval around the (FF/UMEC/VI versus BUD/FOR+TIO) treatment difference was above -50 milliliter.|Mean Difference (Net)|0.011|STANDARD_ERROR_OF_MEAN|0.0154|||TWO_SIDED|95.0|-0.02|0.041|||||The primary treatment effect estimated (hypothetical effect) excluded data following intercurrent events: discontinuation of treatment, taking wrong treatment, taking prohibited medication, unblinding, noncompliance, COPD exacerbation or pneumonia.|||0.041|-0.020|
70917152|NCT03478696|141324736|SUPERIORITY||Mean Difference (Net)|0.026|STANDARD_ERROR_OF_MEAN|0.0122||0.037|TWO_SIDED|95.0|0.002|0.049||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 2 using p-values.|Mixed model repeated measures||Day 2|||0.049|0.002|0.037
70917153|NCT03478696|141324736|SUPERIORITY||Mean Difference (Net)|0.063|STANDARD_ERROR_OF_MEAN|0.0134|<|0.001|TWO_SIDED|95.0|0.036|0.089||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 28 using p-values.|Mixed model repeated measures||Day 28|||0.089|0.036|<0.001
70917154|NCT03478696|141324736|SUPERIORITY||Mean Difference (Net)|0.054|STANDARD_ERROR_OF_MEAN|0.0144|<|0.001|TWO_SIDED|95.0|0.026|0.083||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 84 using p-values.|Mixed model repeated measures||Day 84|||0.083|0.026|<0.001
70917155|NCT03478696|141324736|SUPERIORITY||Mean Difference (Net)|0.051|STANDARD_ERROR_OF_MEAN|0.0157||0.001|TWO_SIDED|95.0|0.021|0.082||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 85 using p-values.|Mixed model repeated measures||Day 85|||0.082|0.021|0.001
70917156|NCT03478696|141324737|SUPERIORITY||Mean Difference (Net)|0.004|STANDARD_ERROR_OF_MEAN|0.0098||0.702|TWO_SIDED|95.0|-0.016|0.023||Only if superiority is achieved on the primary study endpoint, then inferences can be made on weighted mean change from Baseline in FEV1 over 0-24 hours on Day 1 using p-values.|Mixed model repeated measures||The treatment effect to be estimated was hypothetical effect if all participants stayed on their randomized study treatment. Only on treatment data was included in analysis.|||0.023|-0.016|0.702
70970754|NCT01964352|141447198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.122|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|95.0|-6.129|-2.114|||Mixed Effects Model for Repeated Measure|||||-2.114|-6.129|<0.0001
70970755|NCT01964352|141447198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.721|STANDARD_ERROR_OF_MEAN|1.008||0.088|TWO_SIDED|95.0|-3.698|0.256|||Mixed Effects Model for Repeated Measure|||||0.256|-3.698|0.0880
70970756|NCT01964352|141447198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.401|STANDARD_ERROR_OF_MEAN|1.029||0.0198|TWO_SIDED|95.0|-4.419|-0.382|||Mixed Effects Model for Repeated Measure|||||-0.382|-4.419|0.0198
71093123|NCT04235374|141693429|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||.05
71093124|NCT05495997|141693430|SUPERIORITY|||||||0.015|||||||ANCOVA|||Mental Imagery Group (PD-MI) compared to Psychoeducation Control Group (PD-Con) at 6 weeks compared to baseline (group-by-time interaction)||||0.015
70917157|NCT03478696|141324738|SUPERIORITY||Mean Difference (Net)|0.016|STANDARD_ERROR_OF_MEAN|0.0141||0.244|TWO_SIDED|95.0|-0.011|0.044||The analysis was performed using mixed model repeated measures analysis, which included covariates of Baseline FEV1, geographical region, treatment, visit, visit by treatment and visit by Baseline interaction.|Mixed model repeated measures||The treatment effect to be estimated was hypothetical effect if all participants stayed on their randomized study treatment. Only on treatment data was included in analysis.|||0.044|-0.011|0.244
70917158|NCT03615924|141324739|SUPERIORITY||Incidence rate ratio|1.06||||0.7597|TWO_SIDED|95.0|0.75|1.5|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||1.50|0.75|0.7597
70917159|NCT03615924|141324740|SUPERIORITY||Incidence rate ratio|1.02||||0.9037|TWO_SIDED|95.0|0.72|1.45|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||1.45|0.72|0.9037
70917160|NCT03615924|141324741|SUPERIORITY||Incidence rate ratio|0.76||||0.7136|TWO_SIDED|95.0|0.17|3.3|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||3.30|0.17|0.7136
70917161|NCT03615924|141324742|SUPERIORITY||Incidence rate ratio|0.84||||0.497|TWO_SIDED|95.0|0.5|1.4|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||1.40|0.50|0.4970
70917162|NCT03615924|141324743|SUPERIORITY||Incidence rate ratio|1.43||||0.1636|TWO_SIDED|95.0|0.87|2.36|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||2.36|0.87|0.1636
70917163|NCT03615924|141324744|SUPERIORITY||Incidence rate ratio|1.68||||0.2011|TWO_SIDED|95.0|0.76|3.75|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||3.75|0.76|0.2011
70917164|NCT03615924|141324746|SUPERIORITY||Incidence rate ratio|0.0||||0.994|TWO_SIDED|95.0|0.0||Upper limit of confidence interval was not calculable due to 0 events in Ticagrelor 15/30/45 mg bd reporting group.||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.|||0.00|0.9940
70917165|NCT03615924|141324747|SUPERIORITY||Incidence rate ratio|0.77||||0.4822|TWO_SIDED|95.0|0.38|1.58|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||1.58|0.38|0.4822
70917166|NCT04141917|141324758|SUPERIORITY||Risk Ratio, log|1.33|||||TWO_SIDED|95.0|0.35|5.02||||||The number of influenza-positive tests was analyzed using a generalized linear mixed model following a Poisson distribution with a log link and robust variance. The model is adjusted for calendar time and an exposure time variable based on shelter capacity. This model includes symptomatic individuals who tested throughout Year 1 of the study (November 15, 2019 - March 31, 2020).||5.02|0.35|
70917167|NCT01184508|141324772|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference (Net)|-1.03||||0.085|TWO_SIDED|90.0|-2.02|-0.05||The comparison between LY2300559 and placebo for the LS mean change from baseline to Month 3 in the number of migraine attacks was conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed-effects model repeated-measures|Fixed effects: pooled investigator, treatment (tx) group, month, tx group\*month, baseline, baseline\*month; Random effect: pts; Repeated effect: month.||||-0.05|-2.02|0.085
70970757|NCT01964352|141447198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.772|STANDARD_ERROR_OF_MEAN|1.003||0.4415|TWO_SIDED|95.0|-2.741|1.196|||Mixed Effects Model for Repeated Measure|||||1.196|-2.741|0.4415
71093125|NCT05495997|141693431|SUPERIORITY|||||||0.993|||||||ANCOVA|||Mental Imagery Group (PD-MI) compared to Psychoeducation Control Group (PD-Con) at 18 weeks compared to baseline (group-by-time interaction)||||0.993
70917168|NCT01184508|141324774|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|1.75||||0.77|TWO_SIDED|90.0|-8.27|11.76||The p-value is for the change from baseline to Month 3 in average duration of photophobia.|Mixed-effects model repeated-measures|Fixed effects: pooled investigator, treatment (tx) group, month, tx group\*month, baseline, baseline\*month; Random effect: pts; Repeated effect: month.||||11.76|-8.27|0.770
70917169|NCT01184508|141324774|SUPERIORITY_OR_OTHER||LS mean difference|7.3||||0.276|TWO_SIDED|90.0|-3.91|18.52||The p-value is for the change from baseline to Month 3 in average duration of phonophobia.|Mixed-effects model repeated-measures|Fixed effects: pooled investigator, tx group, month, tx group\*month, baseline, baseline\*month; Random effect: pts; Repeated effect: month.||||18.52|-3.91|0.276
70917170|NCT01184508|141324774|SUPERIORITY_OR_OTHER||LS mean difference|-2.7||||0.606|TWO_SIDED|90.0|-11.51|6.1||The p-value is for the change from baseline to Month 3 in average duration of nausea.|Mixed-effects model repeated-measures|Fixed effects: pooled investigator, tx group, month, tx group\*month, baseline, baseline\*month; Random effect: pts; Repeated effect: month.||||6.10|-11.51|0.606
70917171|NCT01184508|141324775|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-1.57||||0.174|TWO_SIDED|90.0|-3.48|0.34||The p-value is for the mean change from baseline to Month 3 in the number of migraine days.|Mixed-effects model repeated-measures|Fixed effects: pooled investigator, treatment (tx) group, month, tx group\*month, baseline, baseline\*month; Random effect: pts; Repeated effect: month.||||0.34|-3.48|0.174
70917172|NCT01184508|141324778|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.27||||0.963|TWO_SIDED|90.0|-9.76|9.23||The p-value is for the change from baseline to Week 12 in MSQ restrictive function score.|ANCOVA|Fixed effects: investigator (pooled site), treatment group, visit, treatment group\*visit, baseline and baseline\*visit.||||9.23|-9.76|0.963
70970758|NCT01964352|141447199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.157|0.282|||Mixed Effects Model for Repeated Measure|||||0.282|0.157|<0.0001
70970759|NCT01964352|141447199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.032||0.5052|TWO_SIDED|95.0|-0.041|0.084|||Mixed Effects Model for Repeated Measure|||||0.084|-0.041|0.5052
70917173|NCT01184508|141324778|SUPERIORITY_OR_OTHER||LS mean difference|-2.17||||0.591|TWO_SIDED|90.0|-8.85|4.5||The p-value is for the change from baseline to Week 12 in MSQ preventive function score.|ANCOVA|Fixed effects: investigator (pooled site), treatment group, visit, treatment group\*visit, baseline and baseline\*visit.||||4.50|-8.85|0.591
70917174|NCT01184508|141324778|SUPERIORITY_OR_OTHER||LS mean difference|1.89||||0.72|TWO_SIDED|90.0|-6.81|10.58||The p-value is for the change from baseline to Week 12 in MSQ emotional function score.|ANCOVA|Fixed effects: investigator (pooled site), treatment group, visit, treatment group\*visit, baseline and baseline\*visit.||||10.58|-6.81|0.720
70917175|NCT01184508|141324779|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.25||||0.688|TWO_SIDED|90.0|-1.3|0.8||The p-value is for the change from baseline to Week 12 in MIBS-4 overall weighted score.|ANCOVA|Fixed effects: pooled investigator, treatment group, and baseline.||||0.80|-1.30|0.688
70917176|NCT01184508|141324781|SUPERIORITY_OR_OTHER|||||||0.607||95.0||||The p-value is for the percentage of participants using breakthrough medication at Month 3.|Fisher Exact|||||||0.607
70917177|NCT04707313|141324790|SUPERIORITY||Difference to placebo|-5.6|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|90.0|-7.41|-3.74|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-3.74|-7.41|<.0001
70917178|NCT04707313|141324790|SUPERIORITY||Difference to placebo|-5.0|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|90.0|-6.8|-3.16|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-3.16|-6.80|<.0001
70917179|NCT04707313|141324790|SUPERIORITY||Difference to Placebo|-9.1|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|90.0|-10.89|-7.28|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-7.28|-10.89|<.0001
70917180|NCT04707313|141324790|SUPERIORITY||Difference to Placebo|-6.6|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|90.0|-8.75|-4.39|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-4.39|-8.75|<.0001
70917181|NCT04707313|141324790|SUPERIORITY||Difference to Placebo|-9.52|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|90.0|-11.43|-7.56|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-7.56|-11.43|<.0001
71093126|NCT05495997|141693432|SUPERIORITY|||||||0.517|||||||ANCOVA|||Mental Imagery Group (PD-MI) compared to Psychoeducation Control Group (PD-Con) at 6 weeks compared to baseline (group-by-time interaction)||||0.517
71093127|NCT05495997|141693433|SUPERIORITY|||||||0.817|||||||ANCOVA|||Mental Imagery Group (PD-MI) compared to Psychoeducation Control Group (PD-Con) at 18 weeks compared to baseline (group-by-time interaction)||||0.817
71093128|NCT02296125|141693466|SUPERIORITY||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.37|0.57|||Log Rank|||||0.57|0.37|<0.0001
71093129|NCT02296125|141693466|OTHER|The china cohort was not powered for superiority|Hazard Ratio (HR)|0.56||||0.0065|TWO_SIDED|95.0|0.37|0.85|||Log Rank|||||0.85|0.37|0.0065
71093130|NCT02296125|141693468|SUPERIORITY||Odds Ratio (OR)|1.51||||0.036|TWO_SIDED|95.0|1.03|2.22|||Regression, Logistic|||||2.22|1.03|0.036
71093131|NCT02296125|141693468|OTHER|The china cohort was not powered for superiority|Odds Ratio (OR)|1.31||||0.485|TWO_SIDED|95.0|0.61|2.84|||Regression, Logistic|||||2.84|0.61|0.485
71093132|NCT02296125|141693469|OTHER|The china cohort was not powered for superiority|Mean Difference (Final Values)|2.48||||0.0133|TWO_SIDED|95.0|1.21|5.09|||Regression, Linear|||||5.09|1.21|0.0133
71093133|NCT02296125|141693469|SUPERIORITY||Mean Difference (Final Values)|2.27|||<|0.0001|TWO_SIDED|95.0|1.68|3.08|||Regression, Linear|||||3.08|1.68|<0.0001
71093134|NCT02296125|141693470|SUPERIORITY||Odds Ratio (OR)|2.78||||0.011|TWO_SIDED|95.0|1.25|6.78|||Regression, Logistic||An odds ratio \> 1 favours osimertinib|||6.78|1.25|0.0110
71093135|NCT02296125|141693470|OTHER|The china cohort was not powered for superiority|Odds Ratio (OR)|1.67||||0.5772|TWO_SIDED|95.0|0.27|12.98|||Regression, Logistic||An odds ratio \>1 favours osimertinib|||12.98|0.27|0.5772
71093136|NCT02296125|141693471|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.0025|TWO_SIDED|95.0|-11.205|-2.403|||Regression, Linear|||||-2.403|-11.205|0.0025
71093137|NCT02296125|141693471|OTHER|The china cohort was not powered for superiority|Mean Difference (Final Values)|-6.59||||0.1348|TWO_SIDED|95.0|-15.246|2.072|||Regression, Linear|||||2.072|-15.246|0.1348
70917182|NCT04707313|141324790|SUPERIORITY||Difference to Placebo|-7.12|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|90.0|-9.41|-4.78|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-4.78|-9.41|<.0001
70917183|NCT04707313|141324790|SUPERIORITY||Difference to Placebo|-9.12|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|90.0|-11.11|-7.08|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-7.08|-11.11|<.0001
70917184|NCT04707313|141324790|SUPERIORITY||Difference to Placebo|-7.18|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|90.0|-9.32|-4.99|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-4.99|-9.32|<.0001
70917185|NCT04707313|141324791|SUPERIORITY||Difference to Placebo|-8.21|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|90.0|-11.66|-4.63|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-4.63|-11.66|<.0001
70917186|NCT04707313|141324791|SUPERIORITY||Difference to placebo|-8.44|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|90.0|-11.83|-4.92|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-4.92|-11.83|<.0001
70917187|NCT04707313|141324791|SUPERIORITY||Difference to Placebo|-12.87|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|90.0|-16.15|-9.47|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-9.47|-16.15|<.0001
70917188|NCT04707313|141324804|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|7.37|||||TWO_SIDED|90.0|2.81|19.3||||||||19.30|2.81|
70917189|NCT04707313|141324804|SUPERIORITY||Odds Ratio (OR)|6.58|||||TWO_SIDED|90.0|2.62|16.53||||||Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.||16.53|2.62|
70917190|NCT04707313|141324804|SUPERIORITY||Odds Ratio (OR)|16.33|||||TWO_SIDED|90.0|6.47|41.24||||||Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.||41.24|6.47|
70917191|NCT04707313|141324804|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|14.24|||||TWO_SIDED|90.0|5.39|37.66||||||||37.66|5.39|
70917192|NCT04707313|141324804|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|30.17|||||TWO_SIDED|90.0|11.35|80.2||||||||80.20|11.35|
70917193|NCT04707313|141324804|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|9.88|||||TWO_SIDED|90.0|2.91|33.53||||||||33.53|2.91|
70917194|NCT04707313|141324804|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|24.41|||||TWO_SIDED|90.0|8.28|71.95||||||||71.95|8.28|
70917195|NCT04707313|141324804|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|12.65|||||TWO_SIDED|90.0|4.56|35.08||||||||35.08|4.56|
70917196|NCT04707313|141324805|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|33.43|||||TWO_SIDED|90.0|3.05|366.64||||||||366.64|3.05|
70970760|NCT01964352|141447199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.208|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.146|0.271|||Mixed Effects Model for Repeated Measure|||||0.271|0.146|<0.0001
71093138|NCT02296125|141693472|SUPERIORITY||Hazard Ratio (HR)|0.799||||0.0462|TWO_SIDED|95.0|0.6409|0.9963|||Log Rank|||||0.9963|0.6409|0.0462
70917197|NCT04707313|141324805|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|34.04|||||TWO_SIDED|90.0|3.1|373.85||||||||373.85|3.10|
70917198|NCT04707313|141324805|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|127.21|||||TWO_SIDED|90.0|10.55|1533.46||||||||1533.46|10.55|
70917199|NCT03165175|141324816|SUPERIORITY|||||||0.72||||||This p-value is the for the group by time (group: intervention/control, by time: baseline/1 month) interaction.|ANOVA|||||||.72
70917200|NCT03165175|141324817|SUPERIORITY|||||||0.598||||||This p-value is the for the group by time (group: intervention/control, by time: baseline/1 month) interaction.|ANOVA|||||||.598
70917201|NCT03165175|141324818|SUPERIORITY|||||||0.954||||||This p-value is the for the group by time (group: intervention/control, by time: baseline/1 month) interaction.|ANOVA|||||||.954
70917202|NCT03165175|141324819|SUPERIORITY|||||||0.167||||||This p-value is the for the group by time (group: intervention/control, by time: baseline/1 month) interaction.|ANOVA|||||||.167
70917203|NCT03165175|141324820|SUPERIORITY|||||||0.022||||||This p-value is the for the group by time (group: intervention/control, by time: baseline/1 month) interaction.|ANOVA|||||||.022
70917204|NCT00762619|141324894|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917205|NCT00762619|141324895|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70970761|NCT01964352|141447199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.032||0.7566|TWO_SIDED|95.0|-0.052|0.072|||Mixed Effects Model for Repeated Measure|||||0.072|-0.052|0.7566
70970762|NCT01964352|141447199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.136|0.261|||Mixed Effects Model for Repeated Measure|||||0.261|0.136|<0.0001
70917206|NCT00762619|141324896|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917207|NCT00762619|141324897|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917208|NCT00762619|141324898|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917209|NCT00762619|141324899|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917210|NCT00762619|141324900|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917211|NCT00762619|141324901|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917212|NCT00762619|141324902|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917213|NCT00762619|141324903|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917214|NCT00762619|141324904|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917215|NCT00762619|141324905|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917216|NCT00762619|141324906|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70970763|NCT01964352|141447199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.032||0.7199|TWO_SIDED|95.0|-0.051|0.073|||Mixed Effects Model for Repeated Measure|||||0.073|-0.051|0.7199
70917217|NCT00762619|141324907|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917218|NCT00762619|141324908|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917219|NCT00762619|141324909|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917220|NCT00762619|141324910|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917221|NCT00762619|141324911|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917222|NCT00762619|141324912|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917223|NCT00762619|141324913|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917224|NCT00762619|141324914|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917225|NCT00762619|141324915|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917226|NCT00762619|141324916|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917227|NCT00762619|141324917|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917228|NCT00762619|141324918|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917229|NCT00762619|141324919|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917230|NCT00762619|141324920|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917231|NCT00762619|141324921|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917232|NCT00762619|141324922|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917233|NCT00762619|141324923|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917234|NCT00762619|141324924|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917235|NCT00762619|141324925|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917236|NCT00762619|141324926|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917237|NCT00762619|141324927|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917238|NCT00762619|141324928|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917239|NCT00762619|141324929|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917240|NCT00762619|141324930|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917241|NCT00762619|141324931|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917242|NCT00762619|141324932|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917243|NCT00762619|141324933|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70970764|NCT01964352|141447200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.052|STANDARD_ERROR_OF_MEAN|0.273|<|0.0001|TWO_SIDED|95.0|1.516|2.588|||Mixed Effects Model for Repeated Measure|||||2.588|1.516|<0.0001
70970765|NCT01964352|141447200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.607|STANDARD_ERROR_OF_MEAN|0.27||0.0246|TWO_SIDED|95.0|0.078|1.137|||Mixed Effects Model for Repeated Measure|||||1.137|0.078|0.0246
70917244|NCT00762619|141324934|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917245|NCT00762619|141324935|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917246|NCT00762619|141324936|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917247|NCT00762619|141324937|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917248|NCT00762619|141324938|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917249|NCT00762619|141324939|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917250|NCT00762619|141324940|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917251|NCT00762619|141324941|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917252|NCT00762619|141324942|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917253|NCT00762619|141324943|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917254|NCT00762619|141324944|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917255|NCT00762619|141324945|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71093139|NCT02296125|141693472|OTHER|The china cohort was not powered for superiority|Hazard Ratio (HR)|0.848||||0.4416|TWO_SIDED|95.0|0.5568|1.291|||Log Rank|||||1.2910|0.5568|0.4416
71153917|NCT00488683|141800065|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.02||||0.82||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup Y||||0.82
70917256|NCT00762619|141324946|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917257|NCT00762619|141324947|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917258|NCT00762619|141324948|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917259|NCT00762619|141324949|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917260|NCT00762619|141324950|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917261|NCT00762619|141324951|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917262|NCT00762619|141324952|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917263|NCT00762619|141324953|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917264|NCT00762619|141324954|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917265|NCT00762619|141324955|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917266|NCT00762619|141324956|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917267|NCT00762619|141324957|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917268|NCT00762619|141324958|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917269|NCT00762619|141324959|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917270|NCT00762619|141324960|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917271|NCT00762619|141324961|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70917272|NCT00961636|141324962|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The closed ordered testing procedure was applied to the efficacy hypotheses. If statistical significance was achieved for the primary hypothesis, then the secondary hypothesis was tested. All tests were performed at significance level 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test was stratified by country||||||<0.001
70917273|NCT00961636|141324963|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The closed ordered testing procedure was applied to the efficacy hypotheses. If statistical significance was achieved for the primary hypothesis, then the secondary hypothesis was tested. All tests were performed at significance level 0.05.|Unconditional Miettinen and Nurminen|||||||<0.001
70917274|NCT02023125|141324982|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|270.0|||||TWO_SIDED|90.0|228.0|320.0|||||The reported values are percentages of geometric least square mean ratio.|Analysis of variance (ANOVA) was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and confidence intervals (CIs).||320|228|
70917275|NCT02023125|141324983|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|116.0|||||TWO_SIDED|90.0|103.0|132.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.||132|103|
70917276|NCT02023125|141324984|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|292.0|||||TWO_SIDED|90.0|258.0|329.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.||329|258|
70917277|NCT02023125|141324985|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|122.0|||||TWO_SIDED|90.0|109.0|136.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.||136|109|
70917278|NCT02023125|141324986|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|377.0|||||TWO_SIDED|90.0|303.0|468.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.||468|303|
70917279|NCT02023125|141324987|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|102.0|||||TWO_SIDED|90.0|87.0|119.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.||119|87.0|
70917280|NCT02023125|141324988|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|328.0|||||TWO_SIDED|90.0|276.0|389.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.||389|276|
70917281|NCT02023125|141324989|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|110.0|||||TWO_SIDED|90.0|96.3|126.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.||126|96.3|
70917282|NCT02023125|141324992|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|306.0|||||TWO_SIDED|90.0|269.0|348.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.||348|269|
70917283|NCT02023125|141324993|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|122.0|||||TWO_SIDED|90.0|110.0|136.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.||136|110|
70917284|NCT02023125|141324994|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|349.0|||||TWO_SIDED|90.0|288.0|422.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.||422|288|
70917285|NCT02023125|141324995|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|109.0|||||TWO_SIDED|90.0|95.3|126.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.||126|95.3|
70917286|NCT02666742|141325008|SUPERIORITY|Continuous variables were compared by two-sample t-tests and categorical variables by chi-square test. All tests were two-tailed, and a P value less than 0.05 was considered to indicate statistical significance. Bonferroni correction was not performed due to prespecified outcomes in the trial. Analyses were performed using GraphPad 6||||||0.001|||||||Chi-squared|||Due to lack of precedent robust clinical data, we performed exploratory study to evaluate safety and efficacy of DOAC vs. Aspirin (ASA) in patients undergoing left ventricular arrhythmia (LVA) ablation; therefore, sample size calculation was not undertaken.||||0.001
70917287|NCT01063517|141325040|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|80.0|0.62|1.03|||||The numerator of the hazard ratio is hazards of progression in olaparib+paclitaxel group and denominator is hazards of progression in placebo+paclitaxel group. Confidence intervals are calculated using the profile-likelihood method.|The analysis was performed using a Cox proportional hazards model with factors for treatment group, ATM status and gastrectomy (full, partial, none).||1.03|0.62|
70917288|NCT01063517|141325041|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|80.0|0.51|1.08|||||The numerator of the hazard ratio is hazards of progression in olaparib+paclitaxel group and denominator is hazards of progression in placebo+paclitaxel group. Confidence intervals are calculated using the profile-likelihood method.|The analysis was performed using a Cox proportional hazards model with factors for treatment group and gastrectomy (full, partial, none).||1.08|0.51|
70917289|NCT01063517|141325042|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.56|||||TWO_SIDED|80.0|0.41|0.75|||||The numerator of the hazard ratio is hazards of death in olaparib+paclitaxel group and denominator is hazards of death in placebo+paclitaxel group. Confidence intervals are calculated using the profile-likelihood method.|The analysis was performed using a Cox proportional hazards model with factors for treatment group, ATM status and gastrectomy (full, partial, none).||0.75|0.41|
71153918|NCT00488683|141800065|SUPERIORITY_OR_OTHER||R-square|0.0013||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup A||||
70917290|NCT01063517|141325043|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.35|||||TWO_SIDED|80.0|0.22|0.56|||||The numerator of the hazard ratio is hazards of death in olaparib+paclitaxel group and denominator is hazards of death in placebo+paclitaxel group. Confidence intervals are calculated using the profile-likelihood method.|The analysis was performed using a Cox proportional hazards model with factors for treatment group and gastrectomy (full, partial, none).||0.56|0.22|
70917291|NCT01350804|141325057|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.79||||0.0458|TWO_SIDED|95.0|1.0|3.2|||Regression, Logistic|||||3.2|1.0|0.0458
70917292|NCT01350804|141325057|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.02||||0.0152|TWO_SIDED|95.0|1.1|3.5|||Regression, Logistic|||||3.5|1.1|0.0152
70917293|NCT01713946|141325069|SUPERIORITY||Odds Ratio (OR)|2.21||||0.008|TWO_SIDED|95.0|1.16|4.2|||Bonferroni-Holm|||||4.20|1.16|0.008
70917294|NCT01713946|141325069|SUPERIORITY||Odds Ratio (OR)|3.93|||<|0.001|TWO_SIDED|95.0|2.1|7.32|||Bonferroni-Holm|||||7.32|2.10|<0.001
70917295|NCT01713946|141325070|SUPERIORITY||Median Difference (Final Values)|15.96||||0.003|TWO_SIDED|95.0|1.98|31.68|||Bonferroni-Holm|||||31.68|1.98|0.003
70917296|NCT01713946|141325070|SUPERIORITY||Odds Ratio (OR)|27.46|||<|0.001|TWO_SIDED|95.0|16.36|43.36|||Bonferroni-Holm|||||43.36|16.36|<0.001
70917297|NCT01713946|141325071|SUPERIORITY||Odds Ratio (OR)|6.55|||||TWO_SIDED|95.0|0.77|55.73||||||||55.73|0.77|
70917298|NCT01713946|141325071|SUPERIORITY||Odds Ratio (OR)|4.99|||||TWO_SIDED|95.0|0.57|44.03||||||||44.03|0.57|
70917299|NCT01713946|141325072|SUPERIORITY||Odds Ratio (OR)|1.77|||||TWO_SIDED|95.0|1.05|2.97||||||||2.97|1.05|
70917300|NCT01713946|141325072|SUPERIORITY||Odds Ratio (OR)|3.82|||||TWO_SIDED|95.0|2.25|6.48||||||||6.48|2.25|
70917301|NCT01713946|141325074|SUPERIORITY||Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-0.4|3.1||||||||3.1|-0.4|
70917302|NCT01713946|141325074|SUPERIORITY||Mean Difference (Final Values)|4.2|||||TWO_SIDED|95.0|2.5|5.9||||||||5.9|2.5|
70917303|NCT01713946|141325075|SUPERIORITY||Hazard Ratio (HR)|1.27|||||TWO_SIDED|95.0|0.77|2.07||||||||2.07|0.77|
70917304|NCT01713946|141325075|SUPERIORITY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.74|1.96||||||||1.96|0.74|
70917305|NCT01713946|141325076|SUPERIORITY||Difference in least square means|-1.1|||||TWO_SIDED|95.0|-4.4|2.1||||||||2.1|-4.4|
70917306|NCT01713946|141325076|SUPERIORITY||Difference in least square means|1.0|||||TWO_SIDED|95.0|-2.2|4.3||||||||4.3|-2.2|
70917307|NCT01713946|141325077|SUPERIORITY||Difference in least square means|-2.1|||||TWO_SIDED|95.0|-10.5|6.2||||||||6.2|-10.5|
71153919|NCT00488683|141800065|SUPERIORITY_OR_OTHER||R-square|0.0014||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup C||||
70917308|NCT01713946|141325077|SUPERIORITY||Difference in least square means|0.4|||||TWO_SIDED|95.0|-7.8|8.6||||||||8.6|-7.8|
70917309|NCT01713946|141325078|SUPERIORITY||Difference in least square means|-2.8|||||TWO_SIDED|95.0|-17.9|12.3||||||||12.3|-17.9|
70917310|NCT01713946|141325078|SUPERIORITY||Difference in least square means|-7.7|||||TWO_SIDED|95.0|-22.0|6.6||||||||6.6|-22.0|
70917311|NCT04411082|141325092|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
70917312|NCT04411082|141325093|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
70917313|NCT04411082|141325094|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
70917314|NCT04411082|141325095|SUPERIORITY||||||>|0.4839|||||||Fisher Exact|||||||>0.4839
70917315|NCT04411082|141325096|SUPERIORITY|||||||0.2065|||||||Fisher Exact|||||||0.2065
70917316|NCT04411082|141325097|SUPERIORITY|||||||0.4839|||||||Fisher Exact|||||||0.4839
70917317|NCT04411082|141325098|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
70917318|NCT04411082|141325099|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
70917319|NCT03622580|141325114|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in adjusted means for the faricimab 6 mg Q8W and the active comparator (aflibercept 2 mg Q8W) arms was greater than -4 letters, then faricimab 6 mg Q8W was considered non-inferior to aflibercept 2 mg Q8W. Non-inferiority was tested one-sided at a significance level of α = 0.0248.|Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.79|||TWO_SIDED|97.5|-2.0|1.6|||||The difference in adjusted means was calculated as Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the non-inferiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||1.6|-2.0|
70917320|NCT03622580|141325114|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in adjusted means for the faricimab 6 mg PTI and the active comparator (aflibercept 2 mg Q8W) arms was greater than -4 letters, then faricimab 6 mg PTI was considered non-inferior to aflibercept 2 mg Q8W. Non-inferiority was tested one-sided at a significance level of α = 0.0248.|Adjusted mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.79|||TWO_SIDED|97.5|-1.1|2.5|||||The difference in adjusted means was calculated as Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the non-inferiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||2.5|-1.1|
70917321|NCT03622580|141325114|SUPERIORITY||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.95||0.4699|TWO_SIDED|97.5|-2.8|1.4||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||1.4|-2.8|0.4699
70917322|NCT03622580|141325114|SUPERIORITY||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.94||0.965|TWO_SIDED|97.5|-2.1|2.2||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||2.2|-2.1|0.9650
70917323|NCT03622580|141325114|SUPERIORITY||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.79||0.7967|TWO_SIDED|97.5|-2.0|1.6||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||1.6|-2.0|0.7967
70917324|NCT03622580|141325114|SUPERIORITY||Adjusted mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.79||0.3772|TWO_SIDED|97.5|-1.1|2.5||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||2.5|-1.1|0.3772
71153920|NCT00488683|141800065|SUPERIORITY_OR_OTHER||R-square|0.0008||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup W-135||||
71153921|NCT00488683|141800065|SUPERIORITY_OR_OTHER||R-square|0.0009||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup Y||||
70917325|NCT03622580|141325115|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in CMH weighted percentages of participants for the faricimab 6 mg Q8W and the active comparator (aflibercept 2 mg Q8W) arms was greater than -10%, then faricimab 6 mg Q8W was considered non-inferior to aflibercept 2 mg Q8W.|Difference in CMH Weighted Percentage|10.2|||||TWO_SIDED|97.5|0.3|20.0||||||The analysis presented here is for the non-inferiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||20.0|0.3|
70917326|NCT03622580|141325115|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in CMH weighted percentages of participants for the faricimab 6 mg PTI and the active comparator (aflibercept 2 mg Q8W) arms was greater than -10%, then faricimab 6 mg PTI was considered non-inferior to aflibercept 2 mg Q8W.|Difference in CMH Weighted Percentage|6.1|||||TWO_SIDED|97.5|-3.6|15.8||||||The analysis presented here is for the non-inferiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||15.8|-3.6|
70917327|NCT03622580|141325115|SUPERIORITY||Difference in CMH Weighted Percentage|7.2||||0.1761|TWO_SIDED|97.5|-4.6|18.9||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||The analysis presented here is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||18.9|-4.6|0.1761
70917328|NCT03622580|141325115|SUPERIORITY||Difference in CMH Weighted Percentage|4.8||||0.3539|TWO_SIDED|97.5|-6.7|16.3||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||The analysis presented here is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||16.3|-6.7|0.3539
70917329|NCT03622580|141325115|SUPERIORITY||Difference in CMH Weighted Percentage|10.2||||0.0237|TWO_SIDED|97.5|0.3|20.0||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||The analysis presented here is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||20.0|0.3|0.0237
70917330|NCT03622580|141325115|SUPERIORITY||Difference in CMH Weighted Percentage|6.1||||0.1677|TWO_SIDED|97.5|-3.6|15.8||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||The analysis presented here is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||15.8|-3.6|0.1677
70917331|NCT03622580|141325118|OTHER||Difference in CMH Weighted Percentage|-2.6|||||TWO_SIDED|95.0|-10.0|4.9||||||This is the difference in percentage of participants gaining ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||4.9|-10.0|
70917332|NCT03622580|141325118|OTHER||Difference in CMH Weighted Percentage|3.5|||||TWO_SIDED|95.0|-4.0|11.1||||||This is the difference in percentage of participants gaining ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||11.1|-4.0|
70917333|NCT03622580|141325118|OTHER||Difference in CMH Weighted Percentage|-0.4|||||TWO_SIDED|95.0|-8.6|7.9||||||This is the difference in percentage of participants gaining ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||7.9|-8.6|
70917334|NCT03622580|141325118|OTHER||Difference in CMH Weighted Percentage|0.7|||||TWO_SIDED|95.0|-7.4|8.8||||||This is the difference in percentage of participants gaining ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||8.8|-7.4|
71093140|NCT00157755|141693479|SUPERIORITY_OR_OTHER|||||||0.215||||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in the frequency of weekly vomiting episodes from when stimulation was turned OFF to when stimulation was turned ON, µ = 0;~Alternative hypothesis: There was a change in frequency of weekly vomiting episodes from when stimulation was turned OFF to when stimulation was turned ON, µ ≠ 0"||||0.215
70917335|NCT03622580|141325118|OTHER||Difference in CMH Weighted Percentage|-2.5|||||TWO_SIDED|95.0|-9.1|4.1||||||This is the difference in percentage of participants gaining ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||4.1|-9.1|
70917336|NCT03622580|141325118|OTHER||Difference in CMH Weighted Percentage|-2.0|||||TWO_SIDED|95.0|-8.5|4.5||||||This is the difference in percentage of participants gaining ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||4.5|-8.5|
70917337|NCT03622580|141325118|OTHER||Difference in CMH Weighted Percentage|0.1|||||TWO_SIDED|95.0|-4.6|4.8||||||This is the difference in percentage of participants gaining ≥0 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||4.8|-4.6|
70917338|NCT03622580|141325118|OTHER||Difference in CMH Weighted Percentage|3.3|||||TWO_SIDED|95.0|-1.0|7.5||||||This is the difference in percentage of participants gaining ≥0 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||7.5|-1.0|
70917339|NCT03622580|141325123|OTHER||Difference in CMH Weighted Percentage|-5.2|||||TWO_SIDED|95.0|-14.0|3.5||||||This is the difference in percentage of participants gaining ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||3.5|-14.0|
70917340|NCT03622580|141325123|OTHER||Difference in CMH Weighted Percentage|1.7|||||TWO_SIDED|95.0|-7.0|10.3||||||This is the difference in percentage of participants gaining ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||10.3|-7.0|
70917341|NCT03622580|141325123|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-9.5|9.5||||||This is the difference in percentage of participants gaining ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||9.5|-9.5|
70917342|NCT03622580|141325123|OTHER||Difference in CMH Weighted Percentage|2.1|||||TWO_SIDED|95.0|-7.1|11.3||||||This is the difference in percentage of participants gaining ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||11.3|-7.1|
70917343|NCT03622580|141325123|OTHER||Difference in CMH Weighted Percentage|-4.5|||||TWO_SIDED|95.0|-11.9|2.9||||||This is the difference in percentage of participants gaining ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.9|-11.9|
70917344|NCT03622580|141325123|OTHER||Difference in CMH Weighted Percentage|-7.2|||||TWO_SIDED|95.0|-14.6|0.2||||||This is the difference in percentage of participants gaining ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||0.2|-14.6|
70917345|NCT03622580|141325123|OTHER||Difference in CMH Weighted Percentage|-0.2|||||TWO_SIDED|95.0|-5.5|5.2||||||This is the difference in percentage of participants gaining ≥0 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||5.2|-5.5|
70917346|NCT03622580|141325123|OTHER||Difference in CMH Weighted Percentage|2.0|||||TWO_SIDED|95.0|-3.0|7.0||||||This is the difference in percentage of participants gaining ≥0 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||7.0|-3.0|
71093141|NCT00157755|141693479|SUPERIORITY_OR_OTHER|||||||1||||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in the frequency of weekly vomiting episodes from when stimulation was turned OFF to when stimulation was turned ON, µ = 0;~Alternative hypothesis: There was a change in frequency of weekly vomiting episodes from when stimulation was turned OFF to when stimulation was turned ON, µ ≠ 0"||||1.0
70917347|NCT03622580|141325128|OTHER||Difference in CMH Weighted Percentage|-0.8|||||TWO_SIDED|95.0|-2.8|1.3||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||1.3|-2.8|
70917348|NCT03622580|141325128|OTHER||Difference in CMH Weighted Percentage|-0.3|||||TWO_SIDED|95.0|-2.2|1.5||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||1.5|-2.2|
70917349|NCT03622580|141325128|OTHER||Difference in CMH Weighted Percentage|-1.8|||||TWO_SIDED|95.0|-4.6|0.9||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||0.9|-4.6|
70917350|NCT03622580|141325128|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-2.2|2.2||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||2.2|-2.2|
70917351|NCT03622580|141325128|OTHER||Difference in CMH Weighted Percentage|-1.1|||||TWO_SIDED|95.0|-4.5|2.2||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.2|-4.5|
70917352|NCT03622580|141325128|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-2.6|3.4||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||3.4|-2.6|
70917353|NCT03622580|141325132|OTHER||Difference in CMH Weighted Percentage|-1.1|||||TWO_SIDED|95.0|-3.5|1.3||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||1.3|-3.5|
70917354|NCT03622580|141325132|OTHER||Difference in CMH Weighted Percentage|-0.9|||||TWO_SIDED|95.0|-3.1|1.3||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||1.3|-3.1|
70917355|NCT03622580|141325132|OTHER||Difference in CMH Weighted Percentage|-2.1|||||TWO_SIDED|95.0|-5.1|0.9||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||0.9|-5.1|
70917356|NCT03622580|141325132|OTHER||Difference in CMH Weighted Percentage|-0.9|||||TWO_SIDED|95.0|-3.5|1.6||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||1.6|-3.5|
70917357|NCT03622580|141325132|OTHER||Difference in CMH Weighted Percentage|-1.2|||||TWO_SIDED|95.0|-5.2|2.8||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.8|-5.2|
70917358|NCT03622580|141325132|OTHER||Difference in CMH Weighted Percentage|-0.4|||||TWO_SIDED|95.0|-4.1|3.3||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||3.3|-4.1|
70917359|NCT03622580|141325136|OTHER||Difference in CMH Weighted Percentage|-4.9|||||TWO_SIDED|95.0|-12.6|2.9||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||2.9|-12.6|
70917360|NCT03622580|141325136|OTHER||Difference in CMH Weighted Percentage|2.0|||||TWO_SIDED|95.0|-5.9|9.8||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||9.8|-5.9|
70917361|NCT03622580|141325136|OTHER||Difference in CMH Weighted Percentage|-8.6|||||TWO_SIDED|95.0|-17.8|0.5||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.5|-17.8|
70917362|NCT03622580|141325136|OTHER||Difference in CMH Weighted Percentage|-0.9|||||TWO_SIDED|95.0|-9.9|8.2||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||8.2|-9.9|
71153922|NCT00488683|141800066|SUPERIORITY_OR_OTHER||R-square|0.34||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup A||||
70917363|NCT03622580|141325139|OTHER||Difference in CMH Weighted Percentage|-3.2|||||TWO_SIDED|95.0|-10.2|3.8||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||3.8|-10.2|
70917364|NCT03622580|141325139|OTHER||Difference in CMH Weighted Percentage|2.4|||||TWO_SIDED|95.0|-4.3|9.2||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||9.2|-4.3|
70917365|NCT03622580|141325139|OTHER||Difference in CMH Weighted Percentage|-4.7|||||TWO_SIDED|95.0|-12.6|3.1||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||3.1|-12.6|
70917366|NCT03622580|141325139|OTHER||Difference in CMH Weighted Percentage|-1.3|||||TWO_SIDED|95.0|-8.9|6.4||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||6.4|-8.9|
70917367|NCT03622580|141325142|OTHER||Difference in CMH Weighted Percentage|0.6|||||TWO_SIDED|95.0|-1.8|2.9||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||2.9|-1.8|
70917368|NCT03622580|141325142|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-2.2|2.3||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||2.3|-2.2|
70917369|NCT03622580|141325142|OTHER||Difference in CMH Weighted Percentage|0.8|||||TWO_SIDED|95.0|-2.0|3.6||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||3.6|-2.0|
70917370|NCT03622580|141325142|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-2.6|2.5||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||2.5|-2.6|
70917371|NCT03622580|141325151|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-1.1|2.0||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||2.0|-1.1|
70917372|NCT03622580|141325151|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-1.1|2.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||2.0|-1.1|
70917373|NCT03622580|141325151|OTHER||Difference in CMH Weighted Percentage|-0.6|||||TWO_SIDED|95.0|-1.9|0.6||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.6|-1.9|
70917374|NCT03622580|141325151|OTHER||Difference in CMH Weighted Percentage|0.5|||||TWO_SIDED|95.0|-1.5|2.5||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||2.5|-1.5|
70917375|NCT03622580|141325152|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-0.4|1.2||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||1.2|-0.4|
70917376|NCT03622580|141325152|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||0.0|0.0|
70917377|NCT03622580|141325152|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.0|0.0|
70917378|NCT03622580|141325152|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.0|0.0|
70917379|NCT03622580|141325159|OTHER||Adjusted mean difference|-36.2|STANDARD_ERROR_OF_MEAN|5.88|||TWO_SIDED|95.0|-47.8|-24.7||||||This is the adjusted mean difference for Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.||-24.7|-47.8|
70917380|NCT03622580|141325159|OTHER||Adjusted mean difference|-26.2|STANDARD_ERROR_OF_MEAN|5.86|||TWO_SIDED|95.0|-37.7|-14.7||||||This is the adjusted mean difference for Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.||-14.7|-37.7|
70970766|NCT01964352|141447200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.952|STANDARD_ERROR_OF_MEAN|0.272|<|0.0001|TWO_SIDED|95.0|1.417|2.487|||Mixed Effects Model for Repeated Measure|||||2.487|1.417|<0.0001
71093142|NCT00157755|141693480|SUPERIORITY_OR_OTHER|||||||0.903||||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in total symptom score from when stimulation was turned OFF to when stimulation was turned ON, µ = 0;~Alternative hypothesis: There was a change in total symptom score from when stimulation was turned OFF to when stimulation was turned ON, µ ≠ 0"||||0.903
70917381|NCT03622580|141325159|OTHER||Adjusted mean difference|-31.1|STANDARD_ERROR_OF_MEAN|6.35|||TWO_SIDED|95.0|-43.6|-18.6||||||This is the adjusted mean difference for Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||-18.6|-43.6|
70917382|NCT03622580|141325159|OTHER||Adjusted mean difference|-23.9|STANDARD_ERROR_OF_MEAN|6.28|||TWO_SIDED|95.0|-36.2|-11.6||||||This is the adjusted mean difference for Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||-11.6|-36.2|
70917383|NCT03622580|141325162|OTHER||Difference in CMH Weighted Percentage|16.0|||||TWO_SIDED|95.0|8.9|23.1||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||23.1|8.9|
70917384|NCT03622580|141325162|OTHER||Difference in CMH Weighted Percentage|12.7|||||TWO_SIDED|95.0|5.4|20.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||20.0|5.4|
70917385|NCT03622580|141325162|OTHER||Difference in CMH Weighted Percentage|15.2|||||TWO_SIDED|95.0|7.3|23.2||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||23.2|7.3|
70917386|NCT03622580|141325162|OTHER||Difference in CMH Weighted Percentage|12.5|||||TWO_SIDED|95.0|4.4|20.6||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||20.6|4.4|
70917387|NCT01930045|141325180|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (GMR)|0.4||||0.507|TWO_SIDED|90.0|0.31|0.52|||Hochberg step-up procedure||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|The hypothesis is that the true Raltegravir C 12 hrs geometric mean ratio (GMR) is not less than 0.4||0.52|0.31|0.507
70917388|NCT01930045|141325180|SUPERIORITY_OR_OTHER||GMR|0.38||||0.624|TWO_SIDED|90.0|0.3|0.49|||Hochberg step-up procedure||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|The hypothesis is that the true Raltegravir C 12 hrs GMR is not less than 0.4||0.49|0.30|0.624
70917389|NCT01930045|141325181|SUPERIORITY_OR_OTHER||GMR|0.81|||||TWO_SIDED|90.0|0.63|1.05|||||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.05|0.63|
70917390|NCT01930045|141325181|SUPERIORITY_OR_OTHER||GMR|0.68|||||TWO_SIDED|90.0|0.5|0.92|||||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||0.92|0.50|
70917391|NCT01930045|141325182|SUPERIORITY_OR_OTHER||GMR|0.78|||||TWO_SIDED|90.0|0.55|1.1|||||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.10|0.55|
70917392|NCT01930045|141325182|SUPERIORITY_OR_OTHER||GMR|0.7|||||TWO_SIDED|90.0|0.48|1.04|||||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.04|0.48|
70970767|NCT01964352|141447200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.507|STANDARD_ERROR_OF_MEAN|0.269||0.0599|TWO_SIDED|95.0|-0.021|1.035|||Mixed Effects Model for Repeated Measure|||||1.035|-0.021|0.0599
70970768|NCT01964352|141447200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.445|STANDARD_ERROR_OF_MEAN|0.274|<|0.0001|TWO_SIDED|95.0|0.907|1.983|||Mixed Effects Model for Repeated Measure|||||1.983|0.907|<0.0001
70917393|NCT01930045|141325183|SUPERIORITY_OR_OTHER||GMR|0.5|||||TWO_SIDED|90.0|0.39|0.65|||||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|The hypothesis is that the true Raltegravir C 12 hrs GMR is not less than 0.4||0.65|0.39|
70917394|NCT01930045|141325183|SUPERIORITY_OR_OTHER||GMR|0.51|||||TWO_SIDED|90.0|0.4|0.64|||||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|The hypothesis is that the true Raltegravir C 12 hrs GMR is not less than 0.4||0.64|0.40|
70917395|NCT01930045|141325184|SUPERIORITY_OR_OTHER||GMR|0.87|||||TWO_SIDED|90.0|0.64|1.18|||||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.18|0.64|
70917396|NCT01930045|141325184|SUPERIORITY_OR_OTHER||GMR|0.89|||||TWO_SIDED|90.0|0.64|1.22|||||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.22|0.64|
70917397|NCT01930045|141325185|SUPERIORITY_OR_OTHER||GMR|0.9|||||TWO_SIDED|90.0|0.58|1.4|||||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.40|0.58|
70917398|NCT01930045|141325185|SUPERIORITY_OR_OTHER||GMR|0.9|||||TWO_SIDED|90.0|0.58|1.41|||||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.41|0.58|
70917399|NCT02138006|141325186|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Log Rank|||||||0.30
70917400|NCT03557658|141325196|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate|106.22|||||TWO_SIDED|90.0|78.34|144.02|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with hepatic function group as a fixed effect, and the subject as a random effect.|Geometric LS Mean was used as PK parameters for total bexagliflozin by hepatic function group.||144.02|78.34|
70917401|NCT03557658|141325196|EQUIVALENCE|The acceptance range for bioequivalence is 80.00 - 125.00%.|Point Estimate|110.84|||||TWO_SIDED|90.0|75.34|163.06|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with hepatic function group as a fixed effect, and the subject as a random effect.|Geometric LS Mean was used as PK parameters for unbound bexagliflozin by hepatic function group||163.06|75.34|
70917402|NCT03557658|141325199|EQUIVALENCE|The acceptance range for bioequivalence is 80.00 - 125.00%.|Point Estimate|128.34|||||TWO_SIDED|90.0|99.98|164.73|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with hepatic function group as a fixed effect, and the subject as a random effect.|Geometric LS Mean was used as PK parameters for total bexagliflozin by hepatic function group||164.73|99.98|
70917403|NCT03557658|141325199|EQUIVALENCE|The acceptance range for bioequivalence is 80.00 - 125.00%.|Point Estimate|132.16|||||TWO_SIDED|90.0|96.46|181.08|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with hepatic function group as a fixed effect, and the subject as a random effect.|Geometric LS Mean was used as PK parameters for unbound bexagliflozin by hepatic function group||181.08|96.46|
71093143|NCT00157755|141693480|SUPERIORITY_OR_OTHER|||||||0.932||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in total symptom score from when stimulation was turned OFF to when stimulation was turned ON, µ = 0;~Alternative hypothesis: There was a change in total symptom score from when stimulation was turned OFF to when stimulation was turned ON, µ ≠ 0"||||0.932
70917404|NCT00463788|141325226|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.126||||0.1109|TWO_SIDED|95.0|0.809|5.591|||Cochran-Mantel-Haenszel|Randomization strata: first- or second line according to Interactive Voice Response System (IVRS).||||5.591|0.809|0.1109
71093144|NCT00157755|141693481|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change from baseline in the long-term frequency of weekly vomiting episodes, µ = 0;~Alternative hypothesis: There was a change from baseline in the long-term frequency of weekly vomiting episodes, µ ≠ 0"||||<0.001
70917405|NCT00463788|141325227|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.675||||0.0324|TWO_SIDED|95.0|0.47|0.969|||Log Rank|||||0.969|0.470|0.0324
70917406|NCT00463788|141325228|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.821||||0.3121|TWO_SIDED|95.0|0.561|1.204|||Log Rank|||||1.204|0.561|0.3121
70917407|NCT00463788|141325229|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.754||||0.5993|TWO_SIDED|95.0|0.262|2.17|||Log Rank|||||2.170|0.262|0.5993
70917408|NCT00360698|141325231|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.68||||0.0499||95.0|0.01|28.37|||Chi-squared||Difference in percentage between groups: Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride group - Insulin Glargine+Metformin+Glimepiride group|The null-hypothesis stated no differences between the 2 treatment groups regarding the percentage of patients with Glycosylated Haemoglobin (HbA1c) level \<7%. A sample size of 98 randomized (49/arm) patients would allow to demonstrate with 80% power that 40 % of patients in the Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride group would achieve a HbA1c level \< 7 % compared to 15 % of patients in the Insulin Glargine+Metformin+Glimepiride group(5% alpha risk, 2-sided test).||28.37|0.01|0.0499
70917409|NCT00360698|141325233|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.116||0.029||95.0|-0.49|-0.03||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|ANCOVA|The analysis is an ANCOVA analysis on the change with group as fixed effect and baseline HbA1c as covariate|Difference between groups: Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride group - Insulin Glargine+Metformin+Glimepiride group|The null-hypothesis stated no difference between the 2 treatment groups regarding the adjusted mean change from baseline in Glycosylated Haemoglobin (HbA1c) at the end of treatment.||-0.03|-0.49|0.029
70917410|NCT00360698|141325235|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.94|STANDARD_ERROR_OF_MEAN|4.987||0.0109||95.0|-22.83|-3.04||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|ANCOVA|The analysis is an ANCOVA analysis on the change with group as fixed effect and baseline daily mean plasma glucose as covariate|Difference between groups: Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride group - Insulin Glargine+Metformin+Glimepiride group|The null-hypothesis stated no differences between the 2 treatment groups regarding the adjusted mean change from baseline in daily mean plasma glucose at the end of treatment.||-3.04|-22.83|0.0109
70917411|NCT00360698|141325236|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.431||0.5762||95.0|-0.61|1.1||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|ANCOVA|The analysis is an ANCOVA analysis on the change with group as fixed effect and baseline weight as covariate|Difference between groups: Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride group - Insulin Glargine+Metformin+Glimepiride group|The null-hypothesis stated no differences between the 2 treatment groups regarding the adjusted mean change from baseline in weight at the end of treatment.||1.1|-0.61|0.5762
70917412|NCT00360698|141325239|SUPERIORITY_OR_OTHER|||||||0.958||95.0||||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|Wilcoxon (Mann-Whitney)|||The null-hypothesis stated no difference between the 2 treatment groups regarding the rate of symptomatic hypoglycemia with plasma glucose \<70 mg/dL during the treatment period.||||0.958
70917413|NCT00360698|141325240|SUPERIORITY_OR_OTHER|||||||0.302||95.0||||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|Wilcoxon (Mann-Whitney)|||The null-hypothesis stated no difference between the 2 treatment groups regarding the rate of nocturnal symptomatic hypoglycemia with plasma glucose \<70 mg/dL during the treatment period.||||0.302
70917414|NCT00360698|141325241|SUPERIORITY_OR_OTHER|||||||0.192||95.0||||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|Wilcoxon (Mann-Whitney)|||The null-hypothesis stated no difference between the 2 treatment groups regarding the rate of severe symptomatic hypoglycemia during the treatment period.||||0.192
70917415|NCT01667796|141325252|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||univariate generalized estimating equati|||||||0.001
70917416|NCT01667796|141325252|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||Adjusted for adherence, body mass index, and oral contraceptive use|Generalized estimating equation|||||||0.008
70917417|NCT02547922|141325257|SUPERIORITY||Geometric Mean Ratio|1.031||||0.9052|TWO_SIDED|95.0|0.621|1.713||The p-values presented are unadjusted and was compared with the respective adjusted significance level (α). If α is not displayed, no formal testing can be performed and the corresponding p-value was nominal.|Mixed Models Analysis||Geometric mean ratio \>1 favours placebo.|The model includes fixed effects for treatment group, visit, stratification factors, log-transformed 24-hour UPCR at baseline, and treatment-by-visit interaction. All data up to and including the date of discontinuation of study treatment were included in the analysis.||1.713|0.621|0.9052
70917418|NCT02547922|141325258|SUPERIORITY||Difference in estimates|-0.08||||0.9929|TWO_SIDED|95.0|-16.92|16.76||At Week 52, the p-values presented are unadjusted and will be compared to the respective adjusted significance level (α). If α is not displayed no formal testing can be performed and the corresponding p-value is nominal.|Cochran-Mantel-Haenszel|||The statistical analysis represents the estimated percentage of responders. The responder/non-responder rates (percentages), the difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach.||16.76|-16.92|0.9929
70917419|NCT02336438|141325269|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.99
70917420|NCT02336438|141325270|SUPERIORITY_OR_OTHER|||||||0.4922|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.4922
70917421|NCT02336438|141325271|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.77
71093145|NCT00157755|141693481|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change from baseline in the long-term frequency of weekly vomiting episodes, µ = 0;~Alternative hypothesis: There was a change from baseline in the long-term frequency of weekly vomiting episodes, µ ≠ 0"||||<0.001
71153923|NCT00488683|141800066|SUPERIORITY_OR_OTHER||R-square|0.14||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup A||||
71153924|NCT00488683|141800066|SUPERIORITY_OR_OTHER||R-square|0.09||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells at 5 months of age and hSBA titers at 12 months of age after a 2, 4-month course of MenACWY-CRM vaccination for the serogroup C||||
70917422|NCT02336438|141325272|SUPERIORITY_OR_OTHER|||||||0.0156|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.0156
70917423|NCT02336438|141325273|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.020
70917424|NCT02336438|141325274|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.13
70917425|NCT04975308|141325299|SUPERIORITY||Hazard Ratio (HR)|0.867||||0.1158|TWO_SIDED|95.0|0.724|1.039|||Log Rank|||||1.039|0.724|0.1158
70917426|NCT04975308|141325300|SUPERIORITY||Hazard Ratio (HR)|0.569|||<|0.0001|TWO_SIDED|95.0|0.441|0.733|||Log Rank|||||0.733|0.441|<0.0001
70917427|NCT04975308|141325301|SUPERIORITY||Hazard Ratio (HR)|0.617||||0.0008|TWO_SIDED|95.0|0.464|0.821|||Log Rank|||||0.821|0.464|0.0008
70917428|NCT02709655|141325320|OTHER||Mean Difference (Final Values)|-2.09|STANDARD_ERROR_OF_MEAN|1.24||0.0937|TWO_SIDED|95.0|-4.54|0.36|||Mixed Models Analysis|||Analysis was performed using an REML-based MMRM approach with freely varying mean and covariance structure and with country, treatment (vortioxetine 10 mg/day, vortioxetine 20 mg/day, fluoxetine, and placebo), and Week as fixed factors and Baseline CDRS-R total score as a continuous covariate, the treatment-by-week interaction, and Baseline CDRS-R-by-Week interaction.||0.36|-4.54|0.0937
70917429|NCT02709655|141325320|OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|1.44||0.2336|TWO_SIDED|95.0|-4.56|1.11|||Mixed Models Analysis|||Analysis was performed using an REML-based MMRM approach with freely varying mean and covariance structure and with country, treatment (vortioxetine 10 mg/day, vortioxetine 20 mg/day, fluoxetine, and placebo), and Week as fixed factors and Baseline CDRS-R total score as a continuous covariate, the treatment-by-week interaction, and Baseline CDRS-R-by-Week interaction.||1.11|-4.56|0.2336
70917430|NCT02709655|141325320|OTHER||Mean Difference (Final Values)|-2.46|STANDARD_ERROR_OF_MEAN|1.44||0.0879|TWO_SIDED|95.0|-5.29|0.37|||Mixed Models Analysis|||Analysis was performed using an REML-based MMRM approach with freely varying mean and covariance structure and with country, treatment (vortioxetine 10 mg/day, vortioxetine 20 mg/day, fluoxetine, and placebo), and Week as fixed factors and Baseline CDRS-R total score as a continuous covariate, the treatment-by-week interaction, and Baseline CDRS-R-by-Week interaction.||0.37|-5.29|0.0879
70970769|NCT01964352|141447200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.268||0.7081|TWO_SIDED|95.0|-0.425|0.626|||Mixed Effects Model for Repeated Measure|||||0.626|-0.425|0.7081
70917431|NCT02709655|141325320|OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|1.7||0.0531|TWO_SIDED|95.0|-6.65|0.04|||Mixed Models Analysis|||Analysis was performed using an REML-based MMRM approach with freely varying mean and covariance structure and with country, treatment (vortioxetine 10 mg/day, vortioxetine 20 mg/day, fluoxetine, and placebo), and Week as fixed factors and Baseline CDRS-R total score as a continuous covariate, the treatment-by-week interaction, and Baseline CDRS-R-by-Week interaction.||0.04|-6.65|0.0531
70917432|NCT00102063|141325341|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||||||0.05
70917433|NCT00102063|141325341|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|||||||0.007
70917434|NCT05190419|141325367|SUPERIORITY||Mean Difference (Net)|-35.4|STANDARD_ERROR_OF_MEAN|9.83|<|0.001|TWO_SIDED|95.0|-54.7|-16.0||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo.|ANCOVA|p-value is calculated by analysis of covariance with treatment group as factor and baseline PASI as covariate.||||-16.0|-54.7|<0.001
70917435|NCT05190419|141325367|SUPERIORITY||Mean Difference (Net)|-43.9|STANDARD_ERROR_OF_MEAN|9.75|<|0.001|TWO_SIDED|95.0|-63.1|-24.8||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo.|ANCOVA|p-value is calculated by analysis of covariance with treatment group as factor and baseline PASI as covariate.||||-24.8|-63.1|<0.001
70917436|NCT05190419|141325367|SUPERIORITY||Mean Difference (Net)|-46.4|STANDARD_ERROR_OF_MEAN|9.75|<|0.001|TWO_SIDED|95.0|-65.6|-27.3||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo.|ANCOVA|p-value is calculated by analysis of covariance with treatment group as factor and baseline PASI as covariate.||||-27.3|-65.6|<0.001
70917437|NCT05061693|141325386|SUPERIORITY||Odds Ratio (OR)|7.1||||0.0061|TWO_SIDED|95.0|1.6|45.4|||Regression, Logistic|Exact Logistic regression: (response at Week 16 = treatment + stratification factor \[Day 1 Investigator's Global Assessment score (3 or 4)\])||||45.4|1.6|0.0061
70917438|NCT05061693|141325386|SUPERIORITY||difference in response rate|28.0|STANDARD_ERROR_OF_MEAN|9.18|||TWO_SIDED|95.0|||||||The standard error of the difference between response rates was from normal approximation.|||||
70917439|NCT05061693|141325386|SUPERIORITY||Odds Ratio (OR)|10.2||||0.0005|TWO_SIDED|95.0|2.3|65.6|||Regression, Logistic|Exact Logistic regression: (response at Week 16 = treatment + stratification factor \[Day 1 Investigator's Global Assessment score (3 or 4)\])||||65.6|2.3|0.0005
70917440|NCT05061693|141325386|SUPERIORITY||difference in response rate|36.3|STANDARD_ERROR_OF_MEAN|9.42|||TWO_SIDED|95.0|||||||The standard error of the difference between response rates was from normal approximation.|||||
70917441|NCT05061693|141325386|SUPERIORITY||Odds Ratio (OR)|16.8|||<|0.0001|TWO_SIDED|95.0|3.9|107.5|||Regression, Logistic|Exact Logistic regression: (response at Week 16 = treatment + stratification factor \[Day 1 Investigator's Global Assessment score (3 or 4)\])||||107.5|3.9|<0.0001
70917442|NCT05061693|141325386|SUPERIORITY||difference in response rate|48.6|STANDARD_ERROR_OF_MEAN|9.3|||TWO_SIDED|95.0|||||||The standard error of the difference between response rates was from normal approximation.|||||
70917443|NCT01152190|141325393|SUPERIORITY_OR_OTHER||Difference in LS Means|0.01|STANDARD_ERROR_OF_MEAN|0.009||0.121||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 between the tadalafil and placebo treatment groups was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.121
70917444|NCT01152190|141325394|SUPERIORITY_OR_OTHER||Difference in LS Means|0.01|STANDARD_ERROR_OF_MEAN|0.008||0.226||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 between the tadalafil and placebo treatment groups was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.226
70917445|NCT01152190|141325395|SUPERIORITY_OR_OTHER||Difference in LS Means|0.01|STANDARD_ERROR_OF_MEAN|0.009||0.208||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 in the prostate peripheral zone RI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.208
70917446|NCT01152190|141325395|SUPERIORITY_OR_OTHER||Difference in LS Means|0.02|STANDARD_ERROR_OF_MEAN|0.009||0.066||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 in the prostate peripheral zone RI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.066
70917447|NCT01152190|141325395|SUPERIORITY_OR_OTHER||Difference in LS Means|0.02|STANDARD_ERROR_OF_MEAN|0.017||0.195||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 in bladder neck RI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.195
70917448|NCT01152190|141325395|SUPERIORITY_OR_OTHER||Difference in LS Means|0.01|STANDARD_ERROR_OF_MEAN|0.022||0.625||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 in bladder neck RI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.625
70917449|NCT01152190|141325396|SUPERIORITY_OR_OTHER||Difference in LS Means|2.63|STANDARD_ERROR_OF_MEAN|3.38||0.439||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 in the prostate transition zone CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.439
70917450|NCT01152190|141325396|SUPERIORITY_OR_OTHER||Difference in LS Means|0.51|STANDARD_ERROR_OF_MEAN|2.867||0.86||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 in the prostate transition zone CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.860
70917451|NCT01152190|141325396|SUPERIORITY_OR_OTHER||Difference in LS Means|3.47|STANDARD_ERROR_OF_MEAN|2.937||0.24||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 in the prostate peripheral zone CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.240
70917452|NCT01152190|141325396|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.55|STANDARD_ERROR_OF_MEAN|2.729||0.839||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 in the prostate peripheral zone CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.839
70970770|NCT01964352|141447201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.457|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.39|0.524|||Mixed Effects Model for Repeated Measure|||||0.524|0.390|<0.0001
70917453|NCT01152190|141325396|SUPERIORITY_OR_OTHER||Difference in LS Means|-4.2|STANDARD_ERROR_OF_MEAN|5.77||0.468||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 in the bladder neck CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.468
70917454|NCT01152190|141325396|SUPERIORITY_OR_OTHER||Difference in LS Means|7.93|STANDARD_ERROR_OF_MEAN|5.199||0.131||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 in the bladder neck CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.131
70917455|NCT00442117|141325414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.074||||0.4982|TWO_SIDED|95.0|-4.196|2.049|||ANOVA|||||2.049|-4.196|0.4982
70917456|NCT00442117|141325415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7601||||0.6544|TWO_SIDED|95.0|-2.585|4.106|||ANOVA|||||4.106|-2.585|0.6544
70917457|NCT00442117|141325416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.704||||0.3796|TWO_SIDED|95.0|-5.528|2.115|||ANOVA|||||2.115|-5.528|0.3796
70917458|NCT00442117|141325417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.432||||0.9622|TWO_SIDED|95.0|-17.56|18.24|||ANOVA|||||18.240|-17.560|0.9622
70917459|NCT00385801|141325454|SUPERIORITY_OR_OTHER|||||||0.86||||||The effect of treatment on intensity of craving was assessed and the threshold for statistical significance was p \< 0.05|Mixed Models Analysis|F=0.03||Intensity of craving||||0.86
70917460|NCT05328297|141325465|SUPERIORITY||Least Square Mean difference|-0.3|STANDARD_ERROR_OF_MEAN|1.96|=|0.438|TWO_SIDED|80.0|-2.84|2.23|||Mixed Model for Repeated Measures (MMRM)|||||2.23|-2.84|=0.438
70917461|NCT03622593|141325536|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in adjusted means for the faricimab 6 mg Q8W and the active comparator (aflibercept 2 mg Q8W) arms was greater than -4 letters, then faricimab 6 mg Q8W was considered non-inferior to aflibercept 2 mg Q8W. Non-inferiority was tested one-sided at a significance level of α = 0.0248.|Adjusted mean difference|1.5|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|97.5|-0.1|3.2|||||The difference in adjusted means was calculated as Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the non-inferiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||3.2|-0.1|
70917462|NCT03622593|141325536|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in adjusted means for the faricimab 6 mg PTI and the active comparator (aflibercept 2 mg Q8W) arms was greater than -4 letters, then faricimab 6 mg PTI was considered non-inferior to aflibercept 2 mg Q8W. Non-inferiority was tested one-sided at a significance level of α = 0.0248.|Adjusted mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|97.5|-1.1|2.1|||||The difference in adjusted means was calculated as Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the non-inferiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||2.1|-1.1|
71093146|NCT00157755|141693482|SUPERIORITY_OR_OTHER|||||||0.014||||||A one-sided significance level of 0.025 was applied to the test. No adjustments were made for multiple comparisons.|binomial, 1 sided|||"Null hypothesis: The percentage of responders was less than or equal to 50%;~Alternative hypothesis: The percentage of responders was greater than 50%"||||0.014
70917463|NCT03622593|141325536|SUPERIORITY||Adjusted mean difference|1.1|STANDARD_ERROR_OF_MEAN|0.83||0.1718|TWO_SIDED|97.5|-0.7|3.0||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||3.0|-0.7|0.1718
71093147|NCT00157755|141693482|SUPERIORITY_OR_OTHER||||||<|0.001||||||A one-sided significance level of 0.025 was applied to the test. No adjustments were made for multiple comparisons.|binomial, 1 sided|||"Null hypothesis: The percentage of responders was less than or equal to 50%;~Alternative hypothesis: The percentage of responders was greater than 50%"||||<0.001
71153925|NCT00488683|141800066|SUPERIORITY_OR_OTHER||R-square|0.16||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup C||||
70917464|NCT03622593|141325536|SUPERIORITY||Adjusted mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.82||0.4602|TWO_SIDED|97.5|-1.2|2.4||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||2.4|-1.2|0.4602
70917465|NCT03622593|141325536|SUPERIORITY||Adjusted mean difference|1.5|STANDARD_ERROR_OF_MEAN|0.73||0.0361|TWO_SIDED|97.5|-0.1|3.2||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||3.2|-0.1|0.0361
70917466|NCT03622593|141325536|SUPERIORITY||Adjusted mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.73||0.493|TWO_SIDED|97.5|-1.1|2.1||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||2.1|-1.1|0.4930
71093148|NCT00157755|141693483|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in total symptom score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in total symptom score from baseline to 12 months, µ ≠ 0"||||<0.001
70917467|NCT03622593|141325537|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in CMH weighted percentages of participants for the faricimab Q8W and the active comparator (aflibercept Q8W) arms was greater than -10%, then faricimab Q8W was considered non-inferior to aflibercept.|Difference in CMH Weighted Percentage|-2.6|||||TWO_SIDED|97.5|-12.6|7.4||||||This analysis is for the non-inferiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||7.4|-12.6|
70917468|NCT03622593|141325537|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in CMH weighted percentages of participants for the faricimab PTI and the active comparator (aflibercept Q8W) arms was greater than -10%, then faricimab PTI was considered non-inferior to aflibercept.|Difference in CMH Weighted Percentage|-3.5|||||TWO_SIDED|97.5|-13.4|6.3||||||This analysis is for the non-inferiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||6.3|-13.4|
70917469|NCT03622593|141325537|SUPERIORITY||Difference in CMH Weighted Percentage|-5.4||||0.3009|TWO_SIDED|97.5|-16.9|6.1||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||This analysis is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||6.1|-16.9|0.3009
70917470|NCT03622593|141325537|SUPERIORITY||Difference in CMH Weighted Percentage|-6.9||||0.1735|TWO_SIDED|97.5|-18.3|4.4||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||This analysis is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||4.4|-18.3|0.1735
70917471|NCT03622593|141325537|SUPERIORITY||Difference in CMH Weighted Percentage|-2.6||||0.5757|TWO_SIDED|97.5|-12.6|7.4||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||This analysis is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||7.4|-12.6|0.5757
70917472|NCT03622593|141325537|SUPERIORITY||Difference in CMH Weighted Percentage|-3.5||||0.4293|TWO_SIDED|97.5|-13.4|6.3||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||This analysis is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||6.3|-13.4|0.4293
70917473|NCT03622593|141325540|OTHER||Difference in CMH Weighted Percentage|3.5|||||TWO_SIDED|95.0|-4.0|11.1||||||This is the difference in percentage of participants gaining ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||11.1|-4.0|
70917474|NCT03622593|141325540|OTHER||Difference in CMH Weighted Percentage|-2.0|||||TWO_SIDED|95.0|-9.1|5.2||||||This is the difference in percentage of participants gaining ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||5.2|-9.1|
70917475|NCT03622593|141325540|OTHER||Difference in CMH Weighted Percentage|5.4|||||TWO_SIDED|95.0|-2.5|13.4||||||This is the difference in percentage of participants gaining ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||13.4|-2.5|
70917476|NCT03622593|141325540|OTHER||Difference in CMH Weighted Percentage|-1.1|||||TWO_SIDED|95.0|-8.9|6.8||||||This is the difference in percentage of participants gaining ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||6.8|-8.9|
70917477|NCT03622593|141325540|OTHER||Difference in CMH Weighted Percentage|3.8|||||TWO_SIDED|95.0|-2.7|10.3||||||This is the difference in percentage of participants gaining ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||10.3|-2.7|
70917478|NCT03622593|141325540|OTHER||Difference in CMH Weighted Percentage|-0.7|||||TWO_SIDED|95.0|-7.3|5.9||||||This is the difference in percentage of participants gaining ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||5.9|-7.3|
70917479|NCT03622593|141325540|OTHER||Difference in CMH Weighted Percentage|0.7|||||TWO_SIDED|95.0|-3.8|5.2||||||This is the difference in percentage of participants gaining ≥0 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||5.2|-3.8|
70917480|NCT03622593|141325540|OTHER||Difference in CMH Weighted Percentage|-0.3|||||TWO_SIDED|95.0|-4.9|4.2||||||This is the difference in percentage of participants gaining ≥0 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||4.2|-4.9|
70917481|NCT03622593|141325545|OTHER||Difference in CMH Weighted Percentage|0.2|||||TWO_SIDED|95.0|-8.5|8.9||||||This is the difference in percentage of participants gaining ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||8.9|-8.5|
70917482|NCT03622593|141325545|OTHER||Difference in CMH Weighted Percentage|-3.5|||||TWO_SIDED|95.0|-11.8|4.8||||||This is the difference in percentage of participants gaining ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||4.8|-11.8|
70917483|NCT03622593|141325545|OTHER||Difference in CMH Weighted Percentage|2.2|||||TWO_SIDED|95.0|-6.9|11.4||||||This is the difference in percentage of participants gaining ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||11.4|-6.9|
70917484|NCT03622593|141325545|OTHER||Difference in CMH Weighted Percentage|-0.8|||||TWO_SIDED|95.0|-9.8|8.1||||||This is the difference in percentage of participants gaining ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||8.1|-9.8|
70917485|NCT03622593|141325545|OTHER||Difference in CMH Weighted Percentage|1.2|||||TWO_SIDED|95.0|-6.2|8.5||||||This is the difference in percentage of participants gaining ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||8.5|-6.2|
70917486|NCT03622593|141325545|OTHER||Difference in CMH Weighted Percentage|-1.1|||||TWO_SIDED|95.0|-8.3|6.2||||||This is the difference in percentage of participants gaining ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||6.2|-8.3|
70917487|NCT03622593|141325545|OTHER||Difference in CMH Weighted Percentage|1.2|||||TWO_SIDED|95.0|-3.8|6.2||||||This is the difference in percentage of participants gaining ≥0 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||6.2|-3.8|
70917488|NCT03622593|141325545|OTHER||Difference in CMH Weighted Percentage|0.2|||||TWO_SIDED|95.0|-4.8|5.2||||||This is the difference in percentage of participants gaining ≥0 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||5.2|-4.8|
71153926|NCT00488683|141800066|SUPERIORITY_OR_OTHER||R-square|0.22||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup W-135||||
70917489|NCT03622593|141325550|OTHER||Difference in CMH Weighted Percentage|0.3|||||TWO_SIDED|95.0|-1.6|2.1||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.1|-1.6|
70917490|NCT03622593|141325550|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-1.8|1.9||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||1.9|-1.8|
70917491|NCT03622593|141325550|OTHER||Difference in CMH Weighted Percentage|-0.1|||||TWO_SIDED|95.0|-2.3|2.1||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.1|-2.3|
70917492|NCT03622593|141325550|OTHER||Difference in CMH Weighted Percentage|-0.3|||||TWO_SIDED|95.0|-2.4|1.9||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||1.9|-2.4|
70917493|NCT03622593|141325550|OTHER||Difference in CMH Weighted Percentage|1.3|||||TWO_SIDED|95.0|-1.9|4.5||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||4.5|-1.9|
70917494|NCT03622593|141325550|OTHER||Difference in CMH Weighted Percentage|1.6|||||TWO_SIDED|95.0|-1.5|4.6||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||4.6|-1.5|
70917495|NCT03622593|141325554|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-2.3|2.2||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.2|-2.3|
70917496|NCT03622593|141325554|OTHER||Difference in CMH Weighted Percentage|0.1|||||TWO_SIDED|95.0|-2.0|2.2||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||2.2|-2.0|
70917497|NCT03622593|141325554|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-2.7|2.6||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.6|-2.7|
70917498|NCT03622593|141325554|OTHER||Difference in CMH Weighted Percentage|-0.3|||||TWO_SIDED|95.0|-2.9|2.3||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||2.3|-2.9|
71153927|NCT00488683|141800066|SUPERIORITY_OR_OTHER||R-square|0.33||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup W-135||||
70917499|NCT03622593|141325554|OTHER||Difference in CMH Weighted Percentage|1.3|||||TWO_SIDED|95.0|-2.0|4.7||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||4.7|-2.0|
70917500|NCT03622593|141325554|OTHER||Difference in CMH Weighted Percentage|1.2|||||TWO_SIDED|95.0|-2.1|4.4||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||4.4|-2.1|
70917501|NCT03622593|141325558|OTHER||Difference in CMH Weighted Percentage|4.8|||||TWO_SIDED|95.0|-3.1|12.7||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||12.7|-3.1|
70917502|NCT03622593|141325558|OTHER||Difference in CMH Weighted Percentage|-1.3|||||TWO_SIDED|95.0|-8.8|6.2||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||6.2|-8.8|
70917503|NCT03622593|141325558|OTHER||Difference in CMH Weighted Percentage|2.6|||||TWO_SIDED|95.0|-6.5|11.6||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||11.6|-6.5|
70917504|NCT03622593|141325558|OTHER||Difference in CMH Weighted Percentage|-1.3|||||TWO_SIDED|95.0|-10.0|7.4||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||7.4|-10.0|
70917505|NCT03622593|141325561|OTHER||Difference in CMH Weighted Percentage|4.7|||||TWO_SIDED|95.0|-2.4|11.8||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||11.8|-2.4|
70917506|NCT03622593|141325561|OTHER||Difference in CMH Weighted Percentage|2.8|||||TWO_SIDED|95.0|-4.1|9.8||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||9.8|-4.1|
70917507|NCT03622593|141325561|OTHER||Difference in CMH Weighted Percentage|1.5|||||TWO_SIDED|95.0|-6.5|9.4||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||9.4|-6.5|
70917508|NCT03622593|141325561|OTHER||Difference in CMH Weighted Percentage|1.7|||||TWO_SIDED|95.0|-6.0|9.3||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||9.3|-6.0|
70917509|NCT03622593|141325564|OTHER||Difference in CMH Weighted Percentage|0.1|||||TWO_SIDED|95.0|-1.4|1.5||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||1.5|-1.4|
70917510|NCT03622593|141325564|OTHER||Difference in CMH Weighted Percentage|-0.7|||||TWO_SIDED|95.0|-1.6|0.2||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||0.2|-1.6|
70917511|NCT03622593|141325564|OTHER||Difference in CMH Weighted Percentage|0.5|||||TWO_SIDED|95.0|-1.1|2.1||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||2.1|-1.1|
70917512|NCT03622593|141325564|OTHER||Difference in CMH Weighted Percentage|-0.5|||||TWO_SIDED|95.0|-1.4|0.4||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.4|-1.4|
70917513|NCT03622593|141325573|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-1.0|1.8||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||1.8|-1.0|
70917514|NCT03622593|141325573|OTHER||Difference in CMH Weighted Percentage|0.5|||||TWO_SIDED|95.0|-1.0|2.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||2.0|-1.0|
70917515|NCT03622593|141325573|OTHER||Difference in CMH Weighted Percentage|0.6|||||TWO_SIDED|95.0|-0.6|1.8||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||1.8|-0.6|
70917516|NCT03622593|141325573|OTHER||Difference in CMH Weighted Percentage|1.2|||||TWO_SIDED|95.0|-0.4|2.8||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||2.8|-0.4|
70917517|NCT03622593|141325574|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||0.0|0.0|
70917518|NCT03622593|141325574|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||0.0|0.0|
70917519|NCT03622593|141325574|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.0|0.0|
70917520|NCT03622593|141325574|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.0|0.0|
70917521|NCT03622593|141325581|OTHER||Adjusted mean difference|-25.7|STANDARD_ERROR_OF_MEAN|5.95|||TWO_SIDED|95.0|-37.4|-14.0||||||This is the adjusted mean difference for Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.||-14.0|-37.4|
70917522|NCT03622593|141325581|OTHER||Adjusted mean difference|-17.6|STANDARD_ERROR_OF_MEAN|5.88|||TWO_SIDED|95.0|-29.2|-6.0||||||This is the adjusted mean difference for Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.||-6.0|-29.2|
70917523|NCT03622593|141325581|OTHER||Adjusted mean difference|-20.0|STANDARD_ERROR_OF_MEAN|6.59|||TWO_SIDED|95.0|-32.9|-7.0||||||This is the adjusted mean difference for Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||-7.0|-32.9|
70917524|NCT03622593|141325581|OTHER||Adjusted mean difference|-14.3|STANDARD_ERROR_OF_MEAN|6.51|||TWO_SIDED|95.0|-27.1|-1.5||||||This is the adjusted mean difference for Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||-1.5|-27.1|
70917525|NCT03622593|141325584|OTHER||Difference in CMH Weighted Percentage|12.3|||||TWO_SIDED|95.0|5.7|18.9||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||18.9|5.7|
70917526|NCT03622593|141325584|OTHER||Difference in CMH Weighted Percentage|8.2|||||TWO_SIDED|95.0|1.5|14.9||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||14.9|1.5|
70917527|NCT03622593|141325584|OTHER||Difference in CMH Weighted Percentage|9.0|||||TWO_SIDED|95.0|1.6|16.3||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||16.3|1.6|
71093149|NCT00157755|141693483|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in total symptom score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in total symptom score from baseline to 12 months, µ ≠ 0"||||<0.001
70917528|NCT03622593|141325584|OTHER||Difference in CMH Weighted Percentage|6.2|||||TWO_SIDED|95.0|-1.2|13.6||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||13.6|-1.2|
70917529|NCT03762668|141325596|NON_INFERIORITY|Noninferiority in VA was declared if the Upper Confidence Limit was less than 0.05.|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.005|||ONE_SIDED|95.0||0.01|||mixed effects repeated measures model||test minus control|||0.01||
70917530|NCT02544152|141325602|OTHER||||||=|0.987|||||||Cochran-Mantel-Haenszel|||P-value is from a Cochran-Mantel-Haenszel (CMH) test stratified by sex and baseline stool consistency||||=0.9870
70917531|NCT00516321|141325620|SUPERIORITY_OR_OTHER||Percentage difference in SVR|7.9||||0.0064|TWO_SIDED|95.0|2.4|13.4||Stratified Cochran-Mantel-Haenszel (CMH) chi-square test adjusted for the randomization strata|Cochran-Mantel-Haenszel||The estimated value reflects the percentage of participants with SVR in the eltrombopag group minus the percentage of participants with SVR in the placebo group. Adjusted for the actual strata: HCV genotype, baseline platelet count, and HCV RNA.|||13.4|2.4|0.0064
70917532|NCT02027558|141325644|SUPERIORITY||Mean Difference (Net)|-3.21|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-4.58|-1.83|||Mixed Models Analysis||The parameter estimate is the improvement in the outcome from baseline to 3-months for the treatment group versus the same improvement in respect to the control group.|||-1.83|-4.58|<.001
70917533|NCT02027558|141325645|SUPERIORITY||Mean Difference (Net)|-16.23|STANDARD_ERROR_OF_MEAN|6.52||0.013|TWO_SIDED|95.0|-29.02|-2.49|||Mixed Models Analysis||The parameter estimate is the improvement in the outcome from baseline to 3-months for the treatment group versus the same improvement in respect to the control group.|||-2.49|-29.02|0.013
70917534|NCT02027558|141325646|SUPERIORITY||Mean Difference (Net)|-20.46|STANDARD_ERROR_OF_MEAN|8.75||0.019|TWO_SIDED|95.0|-37.63|-3.29|||Mixed Models Analysis||The parameter estimate is the improvement in the outcome from baseline to 3-months for the treatment group versus the same improvement in respect to the control group.|||-3.29|-37.63|0.019
70917535|NCT02027558|141325647|SUPERIORITY||Mean Difference (Net)|10.49|STANDARD_ERROR_OF_MEAN|3.04||0.001|TWO_SIDED|95.0|4.53|16.44|||Mixed Models Analysis||The parameter estimate is the improvement in the outcome from baseline to 3-months for the treatment group versus the same improvement in respect to the control group.|||16.44|4.53|0.001
70917536|NCT02027558|141325648|SUPERIORITY||Mean Difference (Net)|4.35|STANDARD_ERROR_OF_MEAN|1.26||0.001|TWO_SIDED|95.0|1.87|6.83|||Mixed Models Analysis||The parameter estimate is the improvement in the outcome from baseline to 3-months for the treatment group versus the same improvement in respect to the control group.|||6.83|1.87|0.001
70917537|NCT02027558|141325649|SUPERIORITY||Mean Difference (Final Values)|-17.42|STANDARD_ERROR_OF_MEAN|4.99||0.0007|TWO_SIDED|95.0|-27.29|-7.55|||t-test, 2 sided|||||-7.55|-27.29|0.0007
70970771|NCT01964352|141447201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.095|0.225|||Mixed Effects Model for Repeated Measure|||||0.225|0.095|<0.0001
70917538|NCT02139046|141325650|SUPERIORITY_OR_OTHER||Difference in Proportions|25.6|||<|0.001|TWO_SIDED|95.0|20.4|30.9||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the Cui, Hung, and Wang (CHW) Z-test which accounts for the interim analysis.||||30.9|20.4|<0.001
70917539|NCT02139046|141325650|SUPERIORITY_OR_OTHER||Difference in Proportions|49.8|||<|0.001|TWO_SIDED|95.0|43.9|55.8||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||55.8|43.9|<0.001
70917540|NCT02139046|141325650|SUPERIORITY_OR_OTHER||Difference in Proportions|10.2||||0.001|TWO_SIDED|95.0|3.5|17.0||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||17.0|3.5|0.001
70917541|NCT02139046|141325650|SUPERIORITY_OR_OTHER||Difference in Proportions|7.5||||0.043|TWO_SIDED|95.0|-0.8|15.9||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||15.9|-0.8|0.043
70917542|NCT02139046|141325651|SUPERIORITY_OR_OTHER||Difference in Proportions|2.1||||0.503|TWO_SIDED|95.0|-4.9|9.0||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||9.0|-4.9|0.503
71093150|NCT00157755|141693484|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in PCS score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in PCS score from baseline to 12 months, µ ≠ 0"||||<0.001
71093151|NCT00157755|141693484|SUPERIORITY_OR_OTHER|||||||0.043||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in PCS score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in PCS score from baseline to 12 months, µ ≠ 0"||||0.043
71093152|NCT00157755|141693485|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in MCS score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in MCS score from baseline to 12 months, µ ≠ 0"||||0.009
70917543|NCT02139046|141325651|SUPERIORITY_OR_OTHER||Difference in Proportions|5.9||||0.064|TWO_SIDED|95.0|-1.2|13.0||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||13.0|-1.2|0.064
70917544|NCT02139046|141325651|SUPERIORITY_OR_OTHER||Difference in Proportions|1.8||||0.561|TWO_SIDED|95.0|-5.1|8.7||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||8.7|-5.1|0.561
70917545|NCT02139046|141325651|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.5||||0.869|TWO_SIDED|95.0|-8.0|6.9||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||6.9|-8.0|0.869
70917546|NCT02139046|141325652|SUPERIORITY_OR_OTHER||Difference in Proportions|47.6|||<|0.001|TWO_SIDED|95.0|41.6|53.6||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||53.6|41.6|<0.001
70917547|NCT02139046|141325652|SUPERIORITY_OR_OTHER||Difference in Proportions|60.5|||<|0.001|TWO_SIDED|95.0|54.6|66.3||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||66.3|54.6|<0.001
70917548|NCT02139046|141325652|SUPERIORITY_OR_OTHER||Difference in Proportions|7.8||||0.036|TWO_SIDED|95.0|-0.5|16.1||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||16.1|-0.5|0.036
70917549|NCT02139046|141325652|SUPERIORITY_OR_OTHER||Difference in Proportions|3.3||||0.364|TWO_SIDED|95.0|-4.9|11.6||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||11.6|-4.9|0.364
70917550|NCT00186186|141325718|SUPERIORITY_OR_OTHER||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||||||<0.00001
70917551|NCT00186186|141325719|SUPERIORITY_OR_OTHER||Percentage|54.0|||||TWO_SIDED|||||||||||||
71153928|NCT00488683|141800066|SUPERIORITY_OR_OTHER||R-square|0.74||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup Y||||
70917552|NCT03959241|141325731|SUPERIORITY||Hazard Ratio (HR)|0.641||||0.001|TWO_SIDED|95.0|0.492|0.835||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of GRFS hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies.||0.835|0.492|0.001
70917553|NCT03959241|141325732|SUPERIORITY|||||||0.995||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||This is the unadjusted analysis. The null hypothesis is that there is no difference of grade II-IV acute GVHD post-transplantation between the treatment groups.||||0.995
70917554|NCT03959241|141325732|SUPERIORITY|||||||0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||This is the unadjusted analysis. The null hypothesis is that there is no difference of grade III-IV acute GVHD post-transplantation between the treatment groups||||0.001
70917555|NCT03959241|141325732|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.879|TWO_SIDED|95.0|0.758|1.267||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of grade II-IV acute GVHD post-transplantation between the treatment groups using a Cox regression model for the cause-specific hazard of aGVHD||1.267|0.758|0.879
70917556|NCT03959241|141325732|SUPERIORITY||Hazard Ratio (HR)|0.386||||0.001|TWO_SIDED|95.0|0.215|0.691||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of grade III-IV aGVHD hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies.||0.691|0.215|0.001
70917557|NCT03959241|141325736|SUPERIORITY|||||||0.005||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||This is the unadjusted analysis. The null hypothesis is that there is no difference of chronic GVHD post-transplantation between the treatment groups||||0.005
70917558|NCT03959241|141325736|SUPERIORITY||Hazard Ratio (HR)|0.556||||0.002|TWO_SIDED|95.0|0.381|0.813||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of the chronic GVHD hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies||0.813|0.381|0.002
70917559|NCT03959241|141325739|SUPERIORITY|||||||0.038||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||The null hypothesis is that there is no difference of Immunosuppression-Free Survival between the treatment groups||||0.038
70917560|NCT03959241|141325740|SUPERIORITY|||||||0.032||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Neutrophil Recovery between the treatment groups||||0.032
70917561|NCT03959241|141325741|SUPERIORITY||||||<|0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Platelet Recovery greater than or equal to 20,000/mm\^3 between the treatment groups||||<0.001
70917562|NCT03959241|141325741|SUPERIORITY||||||<|0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Platelet Recovery greater than or equal to 50,000/mm\^3 between the treatment groups||||<0.001
70917563|NCT03959241|141325742|SUPERIORITY||||||<|0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Lymphocyte Recovery between the treatment groups||||<0.001
70917564|NCT03959241|141325743|SUPERIORITY|||||||0.919||||||Statistical significance was determined using a pre-specified threshold of 0.05|Fisher Exact|||The null hypothesis is that there is no difference of Donor Cell Engraftment at Day 28 after transplantation between the treatment groups||||0.919
70917565|NCT03959241|141325743|SUPERIORITY|||||||0.198||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Fisher Exact|||The null hypothesis is that there is no difference of Donor Cell Engraftment at Day 100 after transplantation between the treatment groups||||0.198
70917566|NCT03959241|141325744|SUPERIORITY|||||||0.67||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference of quantitative donor chimerism at Day 28 after transplantation between the treatment groups||||0.670
70917567|NCT03959241|141325744|SUPERIORITY|||||||0.607||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference of quantitative donor chimerism at Day 100 after transplantation between the treatment groups||||0.607
70917568|NCT03959241|141325745|SUPERIORITY|||||||0.906||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||This is the unadjusted analysis. The null hypothesis is that there is no difference of Disease Relapse between the treatment groups||||0.906
70917569|NCT03959241|141325745|SUPERIORITY||Hazard Ratio (HR)|0.985||||0.947|TWO_SIDED|95.0|0.641|1.515||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of Disease Relapse hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies||1.515|0.641|0.947
70970772|NCT01964352|141447201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.398|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.331|0.465|||Mixed Effects Model for Repeated Measure|||||0.465|0.331|<0.0001
70917570|NCT03959241|141325746|SUPERIORITY|||||||0.167||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||This is the unadjusted analysis. The null hypothesis is that there is no difference of Treatment-related Mortality between the treatment groups||||0.167
70917571|NCT03959241|141325746|SUPERIORITY||Hazard Ratio (HR)|0.675||||0.133|TWO_SIDED|95.0|0.404|1.127||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of Treatment-related Mortality hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies||1.127|0.404|0.133
70917572|NCT03959241|141325750|SUPERIORITY|||||||0.018||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Grade 2 and 3 infections between the treatment groups||||0.018
70917573|NCT03959241|141325751|SUPERIORITY|||||||0.825||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of CMV between the treatment groups||||0. 825
70917574|NCT03959241|141325752|SUPERIORITY|||||||0.351||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||This is the unadjusted analysis. The null hypothesis is that there is no difference of Disease-Free Survival between the treatment groups||||0.351
70917575|NCT03959241|141325752|SUPERIORITY||Hazard Ratio (HR)|0.847||||0.32|TWO_SIDED|95.0|0.61|1.176||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of Disease-Free Survival hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies||1.176|0.610|0.320
70917576|NCT03959241|141325753|SUPERIORITY|||||||0.335||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||This is the unadjusted analysis. The null hypothesis is that there is no difference of Overall Survival between the treatment groups||||0.335
70917577|NCT03959241|141325753|SUPERIORITY||Hazard Ratio (HR)|0.797||||0.252|TWO_SIDED|95.0|0.541|1.175||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of the Overall Survival hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies||1.175|0.541|0.252
70917578|NCT03691428|141325774|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
70917579|NCT03691428|141325775|SUPERIORITY|A multivariate dyadic linear growth curve model was used to predict the trajectories of psychological well-being (Raudenbush, Brennan, \& Barnett, 1995).|||||<|0.05|||||||Mixed Models Analysis|||||||<.05
70917580|NCT03691428|141325776|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
70917581|NCT03691428|141325777|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
71093153|NCT00157755|141693485|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in MCS score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in MCS score from baseline to 12 months, µ ≠ 0"||||0.001
70917582|NCT03691428|141325778|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
70917583|NCT02527148|141325779|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Improvement from preoperative to 6 weeks for the control cases||||<0.0001
70917584|NCT02527148|141325779|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Improvement from preoperative to 6 weeks for the Shapematch cases||||<0.0001
70917585|NCT02527148|141325779|SUPERIORITY|||||||0.0004|||||||t-test, 2 sided|||To compare improvement of OKS from preoperative to 6 weeks between both groups.||||0.0004
70917586|NCT02527148|141325779|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Improvement from preoperative to 6 months for Control cases.||||<0.0001
70917587|NCT02527148|141325779|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Improvement form preoperative to 6 months for Shapematch cases.||||<0.0001
70917588|NCT02527148|141325779|SUPERIORITY|||||||0.3894|||||||t-test, 2 sided|||To compare improvement of OKS from preoperative to 6 months between both groups.||||0.3894
70917589|NCT02527148|141325779|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Improvement from preoperative to 12 months for the Control cases||||<0.0001
70917590|NCT02527148|141325779|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Improvement from preoperative to 12 months for the Shapematch cases||||<0.0001
70917591|NCT02527148|141325779|SUPERIORITY|||||||0.4387|||||||t-test, 2 sided|p-values from repeated ANOVA with change from preoperative variable/scores as dependent variable.||To compare improvement of OKS from preoperative to 12 months between both groups.||||0.4387
70917592|NCT02527148|141325779|SUPERIORITY|||||||0.261|||||||t-test, 2 sided|||To compare improvement of OKS from preoperative to 2 years between both groups.||||0.2610
70917593|NCT02527148|141325779|SUPERIORITY|||||||0.8458|||||||t-test, 2 sided|||To compare improvement of OKS from preoperative to 5 years between both groups.||||0.8458
70917594|NCT02527148|141325780|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||To compare mean duration of surgery between both groups.||||0.10
70917595|NCT02527148|141325781|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||To compare wound length between both groups.||||0.05
70917596|NCT02527148|141325783|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||To compare average length of hospital stay between both groups.||||0.07
70917597|NCT02527148|141325784|SUPERIORITY||Mean Difference (Final Values)|-0.023||||0.55|TWO_SIDED||||||t-test, 2 sided|||Comparison of baseline differences||||0.55
70917598|NCT02527148|141325784|SUPERIORITY||Mean Difference (Final Values)|-0.043||||0.23|TWO_SIDED||||||t-test, 2 sided|||Analysis of QALY between each instrument platform at 12-months||||0.23
70917599|NCT02527148|141325785|EQUIVALENCE|To determine equivalence in baseline characteristics between the control and intervention group.||||||0.724|||||||t-test, 2 sided|||To compare VAS rest preoperatively between both groups.||||0.7240
70917600|NCT02527148|141325785|EQUIVALENCE|To determine equivalence in baseline characteristics between the control and intervention group.||||||0.7545|||||||t-test, 2 sided|||To compare VAS mobilisation preoperatively between both groups.||||0.7545
70917601|NCT02527148|141325785|NON_INFERIORITY|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.6921|||||||t-test, 2 sided|||To compare VAS rest at 6 weeks between both groups.||||0.6921
70917602|NCT02527148|141325785|NON_INFERIORITY|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.9601|||||||t-test, 2 sided|||To compare VAS mobilisation at 6 weeks between both groups.||||0.9601
70917603|NCT02527148|141325785|NON_INFERIORITY|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.0697|||||||t-test, 2 sided|||To compare VAS rest at 6 months between both groups.||||0.0697
70917604|NCT02527148|141325785|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.0342|||||||t-test, 2 sided|||To compare VAS mobilisation at 6 months between both groups.||||0.0342
70917605|NCT02527148|141325785|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.3487|||||||t-test, 2 sided|||To compare VAS rest at 12 months between both groups.||||0.3487
70917606|NCT02527148|141325785|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.2201|||||||t-test, 2 sided|||To compare VAS mobilisation at 1 year between both groups.||||0.2201
70917607|NCT02527148|141325785|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.2291|||||||t-test, 2 sided|||To compare VAS rest at 2 years between both groups.||||0.2291
70917608|NCT02527148|141325785|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.6436|||||||t-test, 2 sided|||To compare VAS mobilisation at 2 years between both groups.||||0.6436
70917609|NCT02527148|141325785|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.4344|||||||t-test, 2 sided|||To compare VAS rest at 5 years between both groups.||||0.4344
70917610|NCT02527148|141325785|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.8732|||||||t-test, 2 sided|||To compare VAS mobilisation at 5 years between both groups.||||0.8732
71093154|NCT00157755|141693486|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in 2-hour gastric emptying from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in 2-hour gastric emptying from baseline to 12 months, µ ≠ 0"||||<0.001
71093155|NCT00157755|141693486|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in 2-hour gastric emptying from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in 2-hour gastric emptying from baseline to 12 months, µ ≠ 0"||||<0.001
71093156|NCT00157755|141693487|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in 4-hour gastric emptying from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in 4-hour gastric emptying from baseline to 12 months, µ ≠ 0"||||0.016
71153929|NCT00488683|141800066|SUPERIORITY_OR_OTHER||R-square|0.53||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup Y||||
70917611|NCT02527148|141325786|SUPERIORITY|||||||0.911|||||||t-test, 2 sided|||To compare WOMAC preoperatively between both groups.||||0.911
70917612|NCT02527148|141325786|SUPERIORITY|||||||0.588|||||||t-test, 2 sided|||To compare WOMAC at 6-weeks between both groups.||||0.588
70917613|NCT02527148|141325786|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||To compare WOMAC at 6-months between both groups.||||0.030
70917614|NCT02527148|141325786|SUPERIORITY|||||||0.131|||||||t-test, 2 sided|||To compare WOMAC at 1-year between both groups.||||0.131
70917615|NCT02527148|141325786|SUPERIORITY|||||||0.347|||||||t-test, 2 sided|||To compare WOMAC at 2-years between both groups.||||0.347
70917616|NCT02527148|141325786|SUPERIORITY|||||||0.341|||||||t-test, 2 sided|||To compare WOMAC at 5-years between both groups.||||0.341
70917617|NCT02527148|141325787|SUPERIORITY|||||||0.452|||||||t-test, 2 sided|||To compare EQ-5D index preoperatively between both groups.||||0.452
70917618|NCT02527148|141325787|SUPERIORITY|||||||0.201|||||||t-test, 2 sided|||To compare EQ-5D VAS preoperatively between both groups.||||0.201
70917619|NCT02527148|141325787|SUPERIORITY|||||||0.741|||||||t-test, 2 sided|||To compare EQ-5D index at 6-weeks between both groups.||||0.741
70917620|NCT02527148|141325787|SUPERIORITY|||||||0.794|||||||t-test, 2 sided|||To compare EQ-5D VAS at 6-weeks between both groups.||||0.794
70917621|NCT02527148|141325787|SUPERIORITY|||||||0.232|||||||t-test, 2 sided|||To compare EQ-5D index at 6-months between both groups.||||0.232
70917622|NCT02527148|141325787|SUPERIORITY|||||||0.513|||||||t-test, 2 sided|||To compare EQ-5D VAS at 6-months between both groups.||||0.513
70917623|NCT02527148|141325787|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||To compare EQ-5D index at 1-year between both groups.||||0.180
70917624|NCT02527148|141325787|SUPERIORITY|||||||0.864|||||||t-test, 2 sided|||To compare EQ-5D VAS at 1-year between both groups.||||0.864
70917625|NCT02527148|141325787|SUPERIORITY|||||||0.223|||||||t-test, 2 sided|||To compare EQ-5D index at 2-year between both groups.||||0.223
70917626|NCT02527148|141325787|SUPERIORITY|||||||0.355|||||||t-test, 2 sided|||To compare EQ-5D VAS at 2-year between both groups.||||0.355
70917627|NCT02527148|141325787|SUPERIORITY|||||||0.314|||||||t-test, 2 sided|||To compare EQ-5D index at 5-year between both groups.||||0.314
70917628|NCT02527148|141325787|SUPERIORITY|||||||0.914|||||||t-test, 2 sided|||To compare EQ-5D VAS at 5-year between both groups.||||0.914
70917629|NCT02527148|141325788|SUPERIORITY|||||||0.523|||||||t-test, 2 sided|||To compare FJS at 6-weeks between both groups.||||0.523
70917630|NCT02527148|141325788|SUPERIORITY|||||||0.932|||||||t-test, 2 sided|||To compare FJS at 6-months between both groups.||||0.932
70917631|NCT02527148|141325788|SUPERIORITY|||||||0.934|||||||t-test, 2 sided|||To compare FJS at 1-year between both groups.||||0.934
70917632|NCT02527148|141325788|SUPERIORITY|||||||0.566|||||||t-test, 2 sided|||To compare FJS at 2-year between both groups.||||0.566
70917633|NCT02527148|141325788|SUPERIORITY|||||||0.263|||||||t-test, 2 sided|||To compare FJS at 5-year between both groups.||||0.263
70917634|NCT02527148|141325789|SUPERIORITY|||||||0.3768|||||||t-test, 2 sided|||To compare IKSS Pain preoperatively between both groups.||||0.3768
70917635|NCT02527148|141325789|SUPERIORITY|||||||0.6425|||||||t-test, 2 sided|||To compare IKSS Function preoperatively between both groups.||||0.6425
70917636|NCT02527148|141325789|SUPERIORITY|||||||0.5041|||||||t-test, 2 sided|||To compare IKSS ROM preoperatively between both groups.||||0.5041
70917637|NCT02527148|141325789|SUPERIORITY|||||||0.223|||||||t-test, 2 sided|||To compare IKSS Pain at 6-weeks between both groups.||||0.2230
70917638|NCT02527148|141325789|SUPERIORITY|||||||0.8209|||||||t-test, 2 sided|||To compare IKSS Function at 6-weeks between both groups.||||0.8209
70917639|NCT02527148|141325789|SUPERIORITY|||||||0.6958|||||||t-test, 2 sided|||To compare IKSS ROM at 6-weeks between both groups.||||0.6958
70917640|NCT02527148|141325789|SUPERIORITY|||||||0.0548|||||||t-test, 2 sided|||To compare IKSS Pain at 6-months between both groups.||||0.0548
71093157|NCT00157755|141693487|SUPERIORITY_OR_OTHER|||||||0.236||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in 4-hour gastric emptying from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in 4-hour gastric emptying from baseline to 12 months, µ ≠ 0"||||0.236
71093158|NCT03785366|141693511|OTHER|"For the primary analysis, a ANOVA model with treatment as a fixed effect and subject as a random effect was used to analyze the uncorrected PK parameters Cmax, Cmean, and AUC0-56 days.~Analysis methodology for the secondary analysis mirrored the approach for the primary analysis applied to the baseline-corrected PK parameters."|test to Reference geometric mean ratio|0.93|||||TWO_SIDED|90.0|0.8|1.25|||ANCOVA|||||1.25|0.80|
70917641|NCT02527148|141325789|SUPERIORITY|||||||0.1958|||||||t-test, 2 sided|||To compare IKSS Function at 6-months between both groups.||||0.1958
70917642|NCT02527148|141325789|SUPERIORITY|||||||0.2786|||||||t-test, 2 sided|||To compare IKSS ROM at 6-months between both groups.||||0.2786
70917643|NCT02527148|141325789|SUPERIORITY|||||||0.2399|||||||t-test, 2 sided|||To compare IKSS Pain at 1-year between both groups.||||0.2399
70917644|NCT02527148|141325789|SUPERIORITY|||||||0.4135|||||||t-test, 2 sided|||To compare IKSS Function at 1-year between both groups.||||0.4135
70917645|NCT02527148|141325789|SUPERIORITY|||||||0.5278|||||||t-test, 2 sided|||To compare IKSS ROM at 1-year between both groups.||||0.5278
70917646|NCT02527148|141325789|SUPERIORITY|||||||0.2992|||||||t-test, 2 sided|||To compare IKSS Pain at 2-year between both groups.||||0.2992
70917647|NCT02527148|141325789|SUPERIORITY|||||||0.5462|||||||t-test, 2 sided|||To compare IKSS Function at 2-year between both groups.||||0.5462
70917648|NCT02527148|141325789|SUPERIORITY|||||||0.5765|||||||t-test, 2 sided|||To compare IKSS ROM at 2-year between both groups.||||0.5765
70917649|NCT02527148|141325789|SUPERIORITY|||||||0.5493|||||||t-test, 2 sided|||To compare IKSS Pain at 5-year between both groups.||||0.5493
70917650|NCT02527148|141325789|SUPERIORITY|||||||0.1705|||||||t-test, 2 sided|||To compare IKSS Function at 5-year between both groups.||||0.1705
70917651|NCT02527148|141325789|SUPERIORITY|||||||0.2918|||||||t-test, 2 sided|||To compare IKSS ROM at 5-year between both groups.||||0.2918
70917652|NCT02527148|141325790|OTHER|||||||0.6|||||||t-test, 2 sided|||Comparison of coronal mechanical axis:hip knee ankle angle between both groups.||||0.6
70917653|NCT02527148|141325790|OTHER|||||||0.002|||||||t-test, 2 sided|||Comparison of coronal angle fem comp and mech axis femur between both groups.||||0.002
70917654|NCT02527148|141325790|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison of coronal angle tibial comp and mech axis tibia between both groups.||||<0.001
70917655|NCT02527148|141325790|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison of sagital tibial component slope between both groups.||||<0.001
70917656|NCT02527148|141325790|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison of Fem comp rotation relative to surg epicond axis+=ER between both groups.||||<0.001
70917657|NCT00891930|141325881|SUPERIORITY|||||||0.013|||||||Regression, Cox|||||||0.0130
70917658|NCT01574807|141325898|SUPERIORITY||Percentage difference|0.0||||1|TWO_SIDED|||||Multiple McNemar tests corrected with Step-down Bonferroni method of Holm. A priori threshold for significance was 0.05.|McNemar|||||||1.00
70917659|NCT00392054|141325903|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.56||||0.0016|TWO_SIDED|95.0|0.35|0.9||Cox regression analysis, stratified by clinical site, was performed and presented as hazard ratios with 95% confidence intervals and a two-sided p-value testing of less than or equal to 0.05 (two-sided) for the Wald test.|Regression, Cox|||Event rates were plotted over time using Kaplan-Meier methodology. Only events occurring after the 90-day treatment period were included in the final analysis. Treatment groups were analyzed on an intention-to-treat basis.||0.90|0.35|0.0016
70917660|NCT00392054|141325905|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.56||||0.03|TWO_SIDED|95.0|0.33|0.95|||Regression, Cox|||||0.95|0.33|0.03
70917661|NCT00392054|141325906|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.52||||0.017|TWO_SIDED|95.0|0.3|0.89|||Regression, Cox|||||0.89|0.3|0.017
70917662|NCT00392054|141325907|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.33|||<|0.0001|TWO_SIDED|95.0|0.28|0.4|||Regression, Cox|||||0.4|0.28|<0.0001
70917663|NCT00392054|141325908|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.66|TWO_SIDED|95.0|0.42|1.72|||Regression, Cox|||||1.72|0.42|0.66
70917664|NCT00857649|141325925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.23|STANDARD_ERROR_OF_MEAN|1.52||0.418|TWO_SIDED|95.0|-1.75|4.21|||ANCOVA|Centre and treatment as factors and baseline score as covariate. Estimate based on Least Squares.||||4.21|-1.75|0.418
70917665|NCT00857649|141325926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.92||0.603|TWO_SIDED|95.0|-2.3|1.34|||ANCOVA|Centre and treatment as factors and baseline score as covariate. Estimate based on Least Squares.||||1.34|-2.30|0.603
70917666|NCT00857649|141325927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.13||0.734|TWO_SIDED|95.0|-0.22|0.31|||ANCOVA|Centre and treatment as factors and baseline score as covariate. Estimate based on Least Squares.||||0.31|-0.22|0.734
70917667|NCT00857649|141325928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.75||0.017|TWO_SIDED|95.0|-3.29|-0.32|||ANCOVA|Centre and treatment as factors and baseline score as covariate. Estimate based on Least Squares.||||-0.32|-3.29|0.017
70917668|NCT00857649|141325929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.98||0.36|TWO_SIDED|95.0|-1.03|2.83|||ANCOVA|Centre and treatment as factors and baseline score as covariate. Estimate based on Least Squares.||||2.83|-1.03|0.360
70917669|NCT03603717|141325967|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
70917670|NCT03603717|141325968|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
70917671|NCT03603717|141325969|SUPERIORITY|||||||0.84|||||||Mixed Models Analysis|||||||0.84
70917672|NCT03603717|141325970|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
70917673|NCT01904071|141326002|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||||||<.0001
70917674|NCT01904071|141326003|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<.05
70917675|NCT01904071|141326004|SUPERIORITY_OR_OTHER||||||<|0.005|||||||ANOVA|||||||<.005
70917676|NCT01904071|141326005|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<.001
71153930|NCT00488683|141800066|SUPERIORITY_OR_OTHER||R-square|0.37||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup A||||
70917677|NCT01904071|141326006|SUPERIORITY_OR_OTHER|||||||0.342|||||||ANOVA|||||||0.342
71153931|NCT00488683|141800066|SUPERIORITY_OR_OTHER||R-square|0.14||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup A||||
70917678|NCT03675581|141326020|OTHER|Relative systemic exposure|Ratio of the geometric means (T/R) %|101.36|STANDARD_DEVIATION|13.7|||TWO_SIDED|90.0|92.83|110.67|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||110.67|92.83|
70917679|NCT03675581|141326021|OTHER|Relative systemic exposure|Ratio of the geometric means (T/R) %|96.4|STANDARD_DEVIATION|8.2|||TWO_SIDED|90.0|91.48|101.58|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T = Test, R = Reference|||101.58|91.48|
70917680|NCT03675581|141326022|OTHER|Relative systemic exposure|Ratio of the geometric means (T/R) %|116.69|STANDARD_DEVIATION|12.6|||TWO_SIDED|90.0|107.63|126.51|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||126.51|107.63|
70917681|NCT03675581|141326023|OTHER|Relative systemic exposure|Ratio of the geometric means (T/R) %|100.89|STANDARD_DEVIATION|18.1|||TWO_SIDED|90.0|89.9|113.23|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||113.23|89.90|
70917682|NCT03675581|141326024|OTHER|Relative systemic exposure|Ratio of the geometric means (T/R) %|101.24|STANDARD_DEVIATION|11.7|||TWO_SIDED|90.0|93.95|109.1|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||109.10|93.95|
70917683|NCT03675581|141326025|OTHER|Relative systemic exposure|Ratio of the geometric means (T/R) %|88.09|STANDARD_DEVIATION|15.0|||TWO_SIDED|90.0|80.03|96.96|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||96.96|80.03|
70917684|NCT01113931|141326030|SUPERIORITY_OR_OTHER||Difference in Percent Cure Rates|0.3|||||TWO_SIDED|95.0|-4.6|5.1||||||The planned sample size of 480 randomized subjects ensured that approximately 200 subjects per group were included in the primary efficacy analyses. The 20% rate of exclusion was to account for subjects who had a negative test for urogenital C. trachomatis at the Baseline visit.||5.1|-4.6|
70917685|NCT01113931|141326033|SUPERIORITY_OR_OTHER||Difference in Percent Cure Rates|0.2|||||TWO_SIDED|95.0|-4.6|5.1||||||The planned sample size of 480 randomized subjects ensured that approximately 200 subjects per group were included in the primary efficacy analyses. The 20% rate of exclusion was to account for subjects who had a negative test for urogenital C. trachomatis at the Baseline visit.||5.1|-4.6|
70917686|NCT01424397|141326038|SUPERIORITY_OR_OTHER||||||||||||||||||Bayesian analysis: The posterior probability of a reduction in TNSS with FP alone compared to Placebo using Mixed Models Analysis was 1.0000|||
70917687|NCT01424397|141326038|SUPERIORITY_OR_OTHER||||||||||||||||||Bayesian analysis: The posterior probability of a reduction in TNSS with SB-705498 alone compared to Placebo using Mixed Models Analysis was 0.7127|||
70917688|NCT01424397|141326038|SUPERIORITY_OR_OTHER||||||||||||||||||Bayesian analysis: The posterior probability of a reduction in TNSS with SB-705498 + FP compared to Placebo using Mixed Models Analysis was 1.0000|||
70917689|NCT01424397|141326038|SUPERIORITY_OR_OTHER||||||||||||||||||Bayesian analysis: The posterior probability of a reduction in TNSS with SB-705498 + FP compared to FP alone using Mixed Models Analysis was 0.0160|||
70917690|NCT01424397|141326040|SUPERIORITY_OR_OTHER||Mean Difference (Net)|81.35|STANDARD_ERROR_OF_MEAN|12.56|||TWO_SIDED|90.0|60.54|102.15||||||Placebo versus FP 200 μg,Nasal Airflow resistance Total WM,0-4 hr||102.15|60.54|
70917691|NCT01424397|141326040|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.31|STANDARD_ERROR_OF_MEAN|19.548|||TWO_SIDED|90.0|-39.7|25.05||||||Placebo versus FP 12 mg SB-705498 , Nasal Airflow resistance Total WM, 0-4 hr||25.05|-39.7|
70917692|NCT01424397|141326040|SUPERIORITY_OR_OTHER||Mean Difference (Net)|72.4|STANDARD_ERROR_OF_MEAN|14.567|||TWO_SIDED|90.0|48.28|96.52||||||Placebo versus SB-705498 + FP 12 mg, Nasal Airflow resistance Total WM, 0-4 hr||96.52|48.28|
71153932|NCT00488683|141800066|SUPERIORITY_OR_OTHER||R-square|0.13||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup C||||
70917693|NCT01424397|141326040|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.95|STANDARD_ERROR_OF_MEAN|14.592|||TWO_SIDED|90.0|-33.1|15.22||||||FP 200 μg versus SB-705498 + FP 12 mg, Nasal Airflow resistance Total WM, 0-4 hr||15.22|-33.1|
70917694|NCT01424397|141326041|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.68|STANDARD_ERROR_OF_MEAN|0.113|||TWO_SIDED|90.0|-0.87|-0.49||||||||-0.49|-0.87|
70917695|NCT01424397|141326041|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.173|||TWO_SIDED|90.0|-0.3|0.27||||||||0.27|-0.30|
70917696|NCT01424397|141326041|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.74|-0.31||||||||-0.31|-0.74|
70917697|NCT01424397|141326041|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.06|0.37||||||||0.37|-0.06|
70917698|NCT00666276|141326067|SUPERIORITY_OR_OTHER||||||=|0.712|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the incidence rate of ADRs."||||=0.712
70917699|NCT00666276|141326068|SUPERIORITY_OR_OTHER||||||=|0.257|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between over 65 and less than 65 in the incidence rate of ADRs."||||=0.257
70917700|NCT00666276|141326069|SUPERIORITY_OR_OTHER||||||=|0.082|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hepatic dysfunctions. The null hypothesis is there is no difference between with Hepatic dysfunction and without Hepatic dysfunction in the incidence rate of ADRs."||||=0.082
70917701|NCT00666276|141326070|SUPERIORITY_OR_OTHER||||||=|0.462|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal dysfunctions. The null hypothesis is there is no difference between with Renal dysfunction and without Renal dysfunction in the incidence rate of ADRs."||||=0.462
70917702|NCT00666276|141326071|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Duration of drug administration. The null hypothesis is there is no difference between over 15 days and less than 15 days in the incidence rate of ADRs."||||<0.001
70917703|NCT00666276|141326072|SUPERIORITY_OR_OTHER||||||=|0.018|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Route of administration. The null hypothesis is there is no difference between oral, injection and switch in the incidence rate of ADRs."||||=0.018
70917704|NCT00666276|141326073|SUPERIORITY_OR_OTHER||||||=|0.311|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Weight. The null hypothesis is there is no difference between over 40kg and less than 40kg in the incidence rate of ADRs."||||=0.311
71153933|NCT00488683|141800066|SUPERIORITY_OR_OTHER||R-square|0.17||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup C||||
70917705|NCT00666276|141326074|SUPERIORITY_OR_OTHER||||||=|0.044|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Concomitant drugs. The null hypothesis is there is no difference between with Concomitant drug and without Concomitant drug in the incidence rate of ADRs."||||=0.044
70917706|NCT00666276|141326075|SUPERIORITY_OR_OTHER||||||=|0.008|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Non-drug therapies. The null hypothesis is there is no difference between with Non-drug therapies and without Non-drug therapies in the incidence rate of ADRs."||||=0.008
70917707|NCT03299816|141326076|SUPERIORITY|||||||0.17||||||The a priori threshold for statistical significance was \<0.05|Mixed effects regression|Urinary albumin-to-creatinine ratio (ACR) was not normally distributed and was natural log transformed for analyses||||||0.17
70917708|NCT03299816|141326077|SUPERIORITY|||||||0.36||||||The a priori threshold for statistical significance was \<0.05|Mixed effects regression|||||||0.36
70917709|NCT03299816|141326078|SUPERIORITY|||||||0.33||||||The a priori threshold for statistical significance was \<0.05|Mixed effects regression|||||||0.33
70917710|NCT03299816|141326079|SUPERIORITY|||||||0.61||||||The a priori threshold for statistical significance was \<0.05|Mixed effects regression|Urinary albumin-to-creatinine ratio (ACR) was not normally distributed and was natural log transformed for analyses||||||0.61
70917711|NCT03299816|141326080|SUPERIORITY|||||||0.73||||||The a priori threshold for statistical significance was \<0.05|Mixed effects regression|Urinary albumin-to-creatinine ratio (ACR) was not normally distributed and was natural log transformed for analyses||||||0.73
70917712|NCT03299816|141326081|SUPERIORITY|||||||0.75||||||The a priori threshold for statistical significance was \<0.05|Mixed effects regression|||||||0.75
70917713|NCT03520413|141326082|EQUIVALENCE|Difference between groups at 12months|Mean Difference (Final Values)|-0.61||||0.02|TWO_SIDED|95.0|-1.12|-0.11|||Mixed Models Analysis|||||-0.11|-1.12|0.02
70917714|NCT03520413|141326083|EQUIVALENCE|Difference between groups at 12months|Mean Difference (Final Values)|-0.25||||0.007|TWO_SIDED|95.0|-0.42|-0.07|||Mixed Models Analysis|||||-0.07|-0.42|0.007
70917715|NCT03520413|141326084|EQUIVALENCE|Difference between groups at 12months|Mean Difference (Final Values)|0.51||||0.0002|TWO_SIDED|95.0|0.25|0.78|||Mixed Models Analysis|||||0.78|0.25|0.0002
70917716|NCT03520413|141326085|EQUIVALENCE|Difference between groups at 12months|Mean Difference (Final Values)|0.39||||0.02|TWO_SIDED|95.0|0.07|0.71|||Mixed Models Analysis|||||0.71|0.07|0.02
70917717|NCT03520413|141326086|EQUIVALENCE|Difference between groups at 6months|Mean Difference (Final Values)|0.19||||0.39|TWO_SIDED|95.0|-0.24|0.62|||Mixed Models Analysis|||||0.62|-0.24|0.39
70917718|NCT03520413|141326087|EQUIVALENCE|Difference between groups at 12months|Mean Difference (Final Values)|-1.16||||0.1|TWO_SIDED|95.0|-2.53|0.21|||Mixed Models Analysis|||||0.21|-2.53|0.10
70917719|NCT02311907|141326088|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||ANOVA|||Generalized linear models (repeated measures analysis of variance \[ANOVA\]) will be used to compare the CIPN between GSH and placebo arms.||||0.21
70917720|NCT02311907|141326089|SUPERIORITY_OR_OTHER|||||||0.63|||||||Log Rank|||||||0.63
70917721|NCT04303156|141326098|OTHER||GMR|2.2|||||TWO_SIDED|90.0|1.68|2.88|||||Severe Renal Impairment / Healthy|Geometric mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|2.88|1.68|
70917722|NCT04303156|141326099|OTHER||GMR|1.93|||||TWO_SIDED|90.0|1.46|2.55|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|2.55|1.46|
71153934|NCT00488683|141800066|SUPERIORITY_OR_OTHER||R-square|0.9||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup W-135||||
70917723|NCT04303156|141326100|OTHER||GMR|1.03|||||TWO_SIDED|90.0|0.67|1.57|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.57|0.67|
70917724|NCT04303156|141326103|OTHER||GMR|0.46|||||TWO_SIDED|90.0|0.35|0.6|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|0.60|0.35|
70917725|NCT04303156|141326104|OTHER||GMR|0.8|||||TWO_SIDED|90.0|0.56|1.14|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.14|0.56|
70917726|NCT04303156|141326105|OTHER||GMR|1.48|||||TWO_SIDED|90.0|1.03|2.14|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|2.14|1.03|
70917727|NCT04303156|141326106|OTHER||GMR|1.38|||||TWO_SIDED|90.0|0.98|1.93|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.93|0.98|
70917728|NCT04303156|141326107|OTHER||GMR|0.94|||||TWO_SIDED|90.0|0.64|1.39|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.39|0.64|
70917729|NCT04303156|141326109|OTHER||GMR|0.97|||||TWO_SIDED|90.0|0.69|1.35|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.35|0.69|
70917730|NCT04303156|141326110|OTHER||GMR|1.82|||||TWO_SIDED|90.0|0.55|6.02|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|6.02|0.55|
70917731|NCT04303156|141326111|OTHER||GMR|2.69|||||TWO_SIDED|90.0|1.51|4.8|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|4.80|1.51|
70917732|NCT04283552|141326146|SUPERIORITY|||||||0.001|||||||Two-tailed Wildoxon signed-rank test|||This statistical analysis is for Reader 1.||||0.001
70917733|NCT04283552|141326146|SUPERIORITY|||||||0.28|||||||Two-tailed Wilcoxon signed-rank test|||This statistical analysis is for Reader 2.||||0.28
70970773|NCT01964352|141447201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.033||0.0023|TWO_SIDED|95.0|0.036|0.165|||Mixed Effects Model for Repeated Measure|||||0.165|0.036|0.0023
71153935|NCT00488683|141800066|SUPERIORITY_OR_OTHER||R-square|0.78||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup W-135||||
70917734|NCT04283552|141326147|SUPERIORITY|||||||0.22|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 1.||||0.22
70917735|NCT04283552|141326147|SUPERIORITY||||||>|0.05|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 2.||||>0.05
70917736|NCT04283552|141326148|SUPERIORITY|||||||0.009|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 1.||||0.009
70917737|NCT04283552|141326148|SUPERIORITY||||||>|0.05|||||||Two-tailed Wilcoxon signed-rank test.|||This statistical analysis is for Reader 2.||||>0.05
70917738|NCT04283552|141326149|SUPERIORITY||||||<|0.001|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 1.||||<0.001
70917739|NCT04283552|141326149|SUPERIORITY|||||||0.02|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 2.||||0.02
70917740|NCT04283552|141326150|SUPERIORITY||||||<|0.001|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 1.||||<0.001
70917741|NCT04283552|141326150|SUPERIORITY|||||||0.02|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 2.||||0.02
70917742|NCT04283552|141326153|SUPERIORITY||||||<|0.001|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis comparing PS-Early Reader 1 to PS-Late Reader 1.||||<0.001
70917743|NCT04283552|141326153|SUPERIORITY||||||<|0.001|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis comparing PS-Early Reader 2 and PS-Late Reader 2.||||<0.001
70917744|NCT02200770|141326171|SUPERIORITY||Hazard Ratio (HR)|0.272|||<|0.0001|TWO_SIDED|95.0|0.1496|0.4961|||Regression, Cox|||||0.4961|0.1496|<0.0001
70917745|NCT02200770|141326172|SUPERIORITY||Odds Ratio (OR)|0.352||||0.0033|TWO_SIDED|95.0|0.1755|0.7059|||Regression, Logistic|||||0.7059|0.1755|0.0033
70917746|NCT02200770|141326173|SUPERIORITY||Mean Difference (Net)|0.134|STANDARD_ERROR_OF_MEAN|1.096||0.9026|TWO_SIDED|95.0|-2.0254|2.2941|||ANCOVA|||||2.2941|-2.0254|0.9026
70917747|NCT02200770|141326174|SUPERIORITY||Rate Ratio|0.566||||0.0034|TWO_SIDED|95.0|0.3866|0.8279|||Negative Binomial Regression|||||0.8279|0.3866|0.0034
70917748|NCT02200770|141326175|SUPERIORITY||Rate Ratio|0.317||||0.0146|TWO_SIDED|95.0|0.1257|0.7972|||Negative Binomial Regression|||||0.7972|0.1257|0.0146
70917749|NCT03401112|141326210|SUPERIORITY|||||||0.0686|||||||Log Rank|||||||0.0686
70917750|NCT03401112|141326210|SUPERIORITY|||||||0.0294|||||||Log Rank|||||||0.0294
70917751|NCT03475316|141326211|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|95.0|-1.14|1.49|||||The estimate parameter is the difference in change at post intervention from pre between dance and treadmill group.|Linear mixed effects model were used to compare changes in the composite score pre and post intervention.||1.49|-1.14|
70970774|NCT01964352|141447201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.297|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|0.229|0.365|||Mixed Effects Model for Repeated Measure|||||0.365|0.229|<0.0001
70970775|NCT01964352|141447201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.033||0.0701|TWO_SIDED|95.0|-0.005|0.123|||Mixed Effects Model for Repeated Measure|||||0.123|-0.005|0.0701
70970776|NCT00477165|141447202|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.59|TWO_SIDED|95.0|0.687|1.196||p\<0.05 for statistical significance|t-test, 2 sided||Repeated-measures logistic regression model, assuming the citalopram effect builds linearly over time starting at week 3.|Null hypothesis: number of patients achieving adequate relief is the same in both Citalopram and Placebo groups||1.196|0.687|0.59
70917752|NCT03475316|141326212|SUPERIORITY||Mean Difference (Net)|166.16|STANDARD_ERROR_OF_MEAN|-202.7|||TWO_SIDED|95.0|-231.12|563.44|||||The estimate parameter reflects change in functional activation/deactivation pattern from pre to post intervention as a function intervention (social dancing vs. treadmill walking).|Estimates with standard errors (SE) are from linear mixed effect models used to examine the difference in change in functional activation/deactivation covariance patterns during the Digit Symbol Substitution test at post intervention from pre intervention between the social dancing and treadmill walking group.||563.44|-231.12|
70917753|NCT03475316|141326212|SUPERIORITY||Mean Difference (Net)|24.6|STANDARD_ERROR_OF_MEAN|28.47|||TWO_SIDED|95.0|-31.2|80.4|||||The estimate parameter reflects change in functional activation/deactivation pattern from pre to post intervention as a function intervention (social dancing vs. treadmill walking).|Estimates with standard errors (SE) and p-values are from linear mixed effect models used to examine the difference in change in functional activation/deactivation covariance patterns during the Flanker interference test at post intervention from pre intervention between the social dancing and treadmill walking group.||80.40|-31.20|
70917754|NCT03475316|141326212|SUPERIORITY||Mean Difference (Net)|58.22|STANDARD_ERROR_OF_MEAN|51.2|||TWO_SIDED|95.0|-42.14|158.58|||||The estimate parameter reflects change in functional activation/deactivation pattern from pre to post intervention as a function intervention (social dancing vs. treadmill walking).|Estimates with standard errors (SE) are from linear mixed effect models used to examine the difference in functional activation/deactivation covariance patterns during the Imagery of Walking-While Talking task at post intervention from pre intervention between the social dancing and treadmill walking group.||158.58|-42.14|
70917755|NCT03475316|141326213|SUPERIORITY||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-5.1|6.64|||||The Estimation Parameter is the difference in change at post from pre between dance and treadmill group.|Linear mixed effects model were used to compare changes in the CHAMPS scores pre and post intervention.||6.64|-5.10|
70917756|NCT03475316|141326214|SUPERIORITY||Mean Difference (Final Values)|7.27|STANDARD_ERROR_OF_MEAN|8.57|||TWO_SIDED|95.0|-11.6|26.14|||||The estimate parameter is the difference in change at post intervention from pre between dance and treadmill group.|Linear mixed effects model were used to compare changes in gait speed pre and post intervention.||26.14|-11.60|
70917757|NCT03475316|141326215|SUPERIORITY||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|5.91|||TWO_SIDED|95.0|-13.4|14.55|||||The estimate parameter is the difference in change at post intervention from pre between dance and treadmill group.|Linear mixed effects model were used to compare changes in unipedal stance time pre and post intervention.||14.55|-13.40|
70917758|NCT03475316|141326217|SUPERIORITY||Mean Difference (Final Values)|1.08|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|95.0|-1.3|3.46|||||The estimate parameter is the difference in change at post intervention from pre between dance and treadmill group.|Linear mixed effects model were used to compare changes in the geriatric depression scale pre and post intervention.||3.46|-1.30|
70917759|NCT05323734|141326358|OTHER||Median Difference (Final Values)|-14.53||||0.0904|TWO_SIDED|95.0|-32.04|2.48|||Wilcoxon Rank-Sum|Wilcoxon Rank-Sum statistic is applied using a 2-sided significance level of 0.05.|The Hodges-Lehmann approach is applied for estimating 95% confidence interval.|||2.48|-32.04|0.0904
71008717|NCT02055976|141525246|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.953|STANDARD_ERROR_OF_MEAN|1.761||0.135|TWO_SIDED|95.0|-5.452|1.546|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.546|-5.452|0.135
71153936|NCT00488683|141800066|SUPERIORITY_OR_OTHER||R-square|0.94||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup Y||||
70917760|NCT05323734|141326359|OTHER||Difference in percentage|6.4||||0.3407|TWO_SIDED|95.0|-6.4|20.1|||Fisher Exact|||||20.1|-6.4|0.3407
70917761|NCT05323734|141326360|OTHER||Odds Ratio (OR)|0.88||||0.7069|TWO_SIDED|95.0|0.46|1.7|||Regression, Logistic||The estimated odds ratio of the ganaxolone group compared to the placebo group based on proportional odds logistic regression with treatment as a factor.|||1.70|0.46|0.7069
70917762|NCT05323734|141326361|OTHER||Odds Ratio (OR)|0.85||||0.6434|TWO_SIDED|95.0|0.42|1.72|||Regression, Logistic||The estimated odds ratio of the ganaxolone group compared to the placebo group based on proportional odds logistic regression with treatment as a factor.|||1.72|0.42|0.6434
70917763|NCT02486718|141326362|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.848||||0.0683|TWO_SIDED|95.0|0.71|1.013|||Log Rank|||||1.013|0.710|0.0683
70917764|NCT02486718|141326363|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.691|0.998||||||||0.998|0.691|
70917765|NCT02486718|141326364|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.704|||||TWO_SIDED|95.0|0.545|0.91||||||||0.910|0.545|
70917766|NCT02486718|141326366|SUPERIORITY||Difference in event-free rates|5.98|||||TWO_SIDED|95.0|-0.28|12.23||||||||12.23|-0.28|
70917767|NCT02486718|141326367|SUPERIORITY||Difference in event-free rates|6.65|||||TWO_SIDED|95.0|-0.06|13.36||||||||13.36|-0.06|
70917768|NCT02486718|141326368|SUPERIORITY||Difference in event-free rates|10.67|||||TWO_SIDED|95.0|1.56|19.79||||||||19.79|1.56|
70917769|NCT02486718|141326369|SUPERIORITY||Difference in event-free rates|5.48|||||TWO_SIDED|95.0|-0.94|11.9||||||||11.90|-0.94|
70917770|NCT02486718|141326370|SUPERIORITY||Difference in event-free rates|4.88|||||TWO_SIDED|95.0|-1.94|11.7||||||||11.70|-1.94|
70917771|NCT02486718|141326371|SUPERIORITY||Difference in event-free rates|10.46|||||TWO_SIDED|95.0|1.16|19.76||||||||19.76|1.16|
70917772|NCT02486718|141326372|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.503|||||TWO_SIDED|95.0|0.332|0.761||||||||0.761|0.332|
70917773|NCT02248480|141326377|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
70917774|NCT01579916|141326437|NON_INFERIORITY_OR_EQUIVALENCE|H0 (null): Rate difference greater than or equal to 5 percentage points. This corresponds to a null hypothesis of: HA (alternative): rate difference \< 5 percentage points.|Rate difference|-1.7|||||TWO_SIDED|95.0|-8.9|0.6|||Score statistic|||Comparison of the rate of fever between the 2 treatment groups was based on the upper limit of the two-sided 95% exact confidence intervals (CIs) for the rate increase (trivalent influenza virus vaccine minus placebo) evaluated against the prespecified equivalence criterion of 5 percentage points||0.6|-8.9|
71153937|NCT00488683|141800066|SUPERIORITY_OR_OTHER||R-square|0.85||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup Y||||
70917775|NCT00732381|141326461|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0|||||ANCOVA|||||||0.006
70917776|NCT00732381|141326462|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||||||<.001
70917777|NCT04090190|141326463|SUPERIORITY|||||||0.6497|||||||Wilcoxon (Mann-Whitney)|||T-test of Wilcoxon rank sum was used to test this non-normal data. Null hypothesis is that the concentration of urine inflammatory markers is the same at baseline and follow-up. This p-value is the probability that the difference in the CRP Calc. Conc. (pg/ml) between baseline and follow-up.||||0.6497
70917778|NCT04090190|141326463|SUPERIORITY|||||||0.4281|||||||Wilcoxon (Mann-Whitney)|||T-test of Wilcoxon rank sum was used to test this non-normal data. Null hypothesis is that the concentration of urine inflammatory markers is the same at baseline and follow-up. This p-value is the probability that the difference in the IL-12/IL-23p40 Calc. Conc. (pg/ml) between baseline and follow-up.||||0.4281
70917779|NCT04090190|141326463|SUPERIORITY|||||||0.3157|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that the baseline and follow-up levels of the urine inflammatory markers are due to chance. This p-value represents the probability that the difference between the baseline and follow-up levels of MCP-1 Calc. Conc. (pg/ml) is due to chance.||||0.3157
70917780|NCT04090190|141326463|SUPERIORITY|||||||0.1463|||||||Wilcoxon (Mann-Whitney)|||This p-value represents the probability that the difference between baseline and follow-up levels of GM-CSF Calc. Conc. (pg/ml) is due to chance.||||0.1463
70917781|NCT04090190|141326463|SUPERIORITY|||||||0.6091|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that the baseline and follow-up levels of the urine inflammatory markers are due to chance. This p-value represents the probability that the difference between the baseline and follow-up levels of IL-1β Calc. Conc. (pg/ml) is due to chance.||||0.6091
70917782|NCT04090190|141326463|SUPERIORITY|||||||0.3011|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that the baseline and follow-up levels of the urine inflammatory markers are due to chance. This p-value represents the probability that the difference between the baseline and follow-up levels of IL-6 Calc. Conc. (pg/ml) is due to chance.||||0.3011
70917783|NCT04090190|141326463|SUPERIORITY|||||||0.5009|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that the baseline and follow-up levels of the urine inflammatory markers are due to chance. This p-value represents the probability that the difference between the baseline and follow-up levels of IL-8 Calc. Conc. (pg/ml) is due to chance.||||0.5009
70917784|NCT00457691|141326466|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.095||||0.8072|TWO_SIDED|95.0|0.892|1.344||p-value from 1-sided log-rank test, stratified by Eastern Cooperative Oncology Group (ECOG) performance status, organ sites with disease, primary tumor site, prior adjuvant treatment|Log Rank|||||1.344|0.892|0.8072
70917785|NCT00457691|141326467|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.171||||0.9163|TWO_SIDED|95.0|0.936|1.466||p-value from 1-sided log-rank test, stratified by ECOG performance status, organ sites with disease, primary tumor site, prior adjuvant treatment|Log Rank|||||1.466|0.936|0.9163
70917786|NCT00028093|141326475|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||Wilcoxon (Mann-Whitney)|||Null hypothesis: there is no difference in the outcome between the two groups||||0.54
70917787|NCT05219253|141326489|SUPERIORITY|The superiority was to be concluded if the lower limit (LL) of the 95% confidence interval (CI) of the adjusted GMC ratio between the HZ/su Group and Placebo Group for anti-gE antibody concentrations was equal to or above (\>=) 3.|GMC Ratio|19.8|||||TWO_SIDED|95.0|14.09|27.82|||ANOVA|||To demonstrate the immunogenicity of HZ/su vaccine compared to Placebo, in terms of anti-gE GMCs, at 1 month post-Dose 2 of study intervention administration (Month 3).||27.82|14.09|
70917788|NCT03086369|141326501|SUPERIORITY||Hazard Ratio (HR)|1.054||||0.7902|TWO_SIDED|95.0|0.728|1.527|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|||1.527|0.728|0.7902
70917789|NCT03086369|141326505|SUPERIORITY||Hazard Ratio (HR)|1.192||||0.3771|TWO_SIDED|95.0|0.806|1.764|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|||1.764|0.806|0.3771
70917790|NCT03086369|141326508|SUPERIORITY||Hazard Ratio (HR)|0.39||||0.017|TWO_SIDED|95.0|0.175|0.872|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).||||0.872|0.175|0.017
70917791|NCT03086369|141326509|SUPERIORITY||Hazard Ratio (HR)|0.718||||0.288|TWO_SIDED|95.0|0.392|1.317|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Appetite loss||1.317|0.392|0.288
70917792|NCT03086369|141326509|SUPERIORITY||Hazard Ratio (HR)|0.788||||0.442|TWO_SIDED|95.0|0.423|1.468|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Constipation||1.468|0.423|0.442
70917793|NCT03086369|141326509|SUPERIORITY||Hazard Ratio (HR)|1.037||||0.883|TWO_SIDED|95.0|0.612|1.755|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Diarrhoea||1.755|0.612|0.883
70917794|NCT03086369|141326509|SUPERIORITY||Hazard Ratio (HR)|0.933||||0.803|TWO_SIDED|95.0|0.532|1.636|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Dyspnoea||1.636|0.532|0.803
70917795|NCT03086369|141326509|SUPERIORITY||Hazard Ratio (HR)|1.053||||0.805|TWO_SIDED|95.0|0.675|1.645|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Fatigue||1.645|0.675|0.805
71153938|NCT00488683|141800066|SUPERIORITY_OR_OTHER||R-square|0.03||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup A||||
70917796|NCT03086369|141326509|SUPERIORITY||Hazard Ratio (HR)|0.784||||0.465|TWO_SIDED|95.0|0.42|1.464|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Financial difficulties||1.464|0.420|0.465
70917797|NCT03086369|141326509|SUPERIORITY||Hazard Ratio (HR)|1.457||||0.231|TWO_SIDED|95.0|0.787|2.698|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Insomnia||2.698|0.787|0.231
70917798|NCT03086369|141326509|SUPERIORITY||Hazard Ratio (HR)|0.914||||0.748|TWO_SIDED|95.0|0.532|1.57|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Nausea and vomiting||1.570|0.532|0.748
70917799|NCT03086369|141326509|SUPERIORITY||Hazard Ratio (HR)|0.947||||0.875|TWO_SIDED|95.0|0.491|1.827|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Pain||1.827|0.491|0.875
70917800|NCT04603924|141326523|OTHER||||||||||||||||||"For the analysis of this efficacy endpoint, missing scores of the WHO Ordinal Scale for Clinical Improvement will be assumed to be \> 2 (i.e., no hospital discharge). Median time-to-clinical improvement and corresponding 95% confidence interval were estimated from the Kaplan-Meier curves. In some cases the 95% confidence interval was Not Evaluable (NE) by this method."|||
70917801|NCT04603924|141326524|OTHER||||||||||||||||||"For the analysis of this efficacy endpoint, missing scores of the WHO Ordinal Scale for Clinical Improvement were be assumed to be \> 2 (i.e., no hospital discharge). Median number of days to a 2-point improvement and corresponding 95% confidence interval were estimated from the Kaplan-Meier curves.~In some cases the 95% confidence interval was Not Evaluable (NE) by this method."|||
70917802|NCT01765543|141326538|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.614|||||TWO_SIDED|90.0|0.484|0.78||||||Analysis of variance (ANOVA) was applied to the log-transformed PK parameters, and then back transformed to provide geometric mean ratio (Period C/Period A) and confidence intervals.||0.780|0.484|
70917803|NCT01765543|141326539|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.596|||||TWO_SIDED|90.0|0.469|0.759||||||ANOVA was applied to the log-transformed PK parameters, and then back transformed to provide geometric mean ratio (Period C/Period A) and confidence intervals.||0.759|0.469|
70917804|NCT01765543|141326540|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.11|||||TWO_SIDED|90.0|0.908|1.36||||||ANOVA was applied to the log-transformed PK parameters, and then back transformed to provide geometric mean ratio (Period C/Period A) and confidence intervals.||1.36|0.908|
70917805|NCT00071799|141326555|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|TWO_SIDED|95.0|||||Log Rank|The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification.||"A 95% CI range value of 'does not exist' is not accommodated in the results table, so all the 95% CI range values are offered here.~Azacitidine: low range of 17.9 months and high range of 'does not exist'.~Conventional Care: low range of 9.8 and high range of 17.0 months."||||0.0001
70970777|NCT00105443|141447206|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6931||||0.00583||95.0|0.5549|0.8658||According to the pre-specified O'Brien-Fleming alpha spending function, the alpha value for this second interim analysis was 0.0073 (corresponding to a nominal value of 0.0077 after taking into account the first interim analysis).|Log Rank||This is the sorafenib to placebo hazard ratio.|"The 2 arms were compared using a 1-sided log-rank test with an overall alpha of 0.02 stratified by region, ECOG PS and tumor burden. In addition to the final analysis at the end of the study, 2 formal interim analyses of overall survival were planned. An alpha spending function was used to ensure that the false positive rate is less than or equal to 0.02 (1-sided). The study was stopped at the second interim analysis, the results of which are reported here."||0.8658|0.5549|0.00583
70917806|NCT00071799|141326555|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.58||||0.0002|TWO_SIDED|95.0|0.43|0.77|||Regression, Cox||Cox proportional hazards model stratified on the randomization factors of FAB and IPSS with model term of treatment.|||0.77|0.43|0.0002
70917807|NCT00071799|141326556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3973||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"Age \< 65 years The Kaplan-Meier median time to death was not reached due to a small number of events, so the KM 25th percentile survival time is presented.~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 7.1 months and high range of 15.6 months.~Conventional Care: low range of 4.4 and high range of 12.4 months."||||0.3973
70917808|NCT00071799|141326556|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"Age \>= 65 years~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 17.1 months and high range of 34.7 months.~Conventional Care: low range of 8.8 and high range of 16.4 months."||||<0.0001
70917809|NCT00071799|141326556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0707||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"Age \>= 75 years. The Kaplan-Meier median time to death was not reached due to a small number of events, so the KM 25th percentile survival time is presented.~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 1.7 months and high range of 15.0 months.~Conventional Care: low range of 4.1 and high range of 7.6 months."||||0.0707
70917810|NCT00071799|141326556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0042||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"Gender: Male~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 17.9 months and high range of 'does not exist'.~Conventional Care: low range of 10.8 and high range of 17.2 months."||||0.0042
70917811|NCT00071799|141326556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0469||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"Gender: Female~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 13.0 months and high range of 'does not exist'.~Conventional Care: low range of 8.2 and high range of 17.6 months."||||0.0469
70917812|NCT00071799|141326556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||95.0||||"95% CI ranges are added here.~Azacitidine: low range of 21.1 months and high range of 'does not exist'.~Conventional Care: low range of 9.3 and high range of 21.9 months."|Log Rank|The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification.||FAB: Refractory anemia with excess blasts (RAEB). All patients were stratified at randomization by FAB classification and IPSS score as determined by the investigator using centrally read bone marrow and cytogenetic data. Subsequently, the FAB classifications and IPSS scores were reviewed by an Independent Review Committee (IRC). The subgroup analyses presented by FAB and IPSS represent the FAB classification and IPSS scores as determined by the IRC.||||0.0056
70917813|NCT00071799|141326556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0322||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"FAB: RAEB in transformation~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 11.7 months and high range of 'does not exist'.~Conventional Care: low range of 9.4 and high range of 17.0 months."||||0.0322
70917814|NCT00071799|141326556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1679||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"WHO: RAEB 1. The Kaplan-Meier median time to death was not reached due to a small number of events, so the KM 25th percentile survival time is presented.~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 6.6 months and high range of 'does not exist'.~Conventional Care: low range of 1.8 and high range of 9.8 months."||||0.1679
70917815|NCT00071799|141326556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0692||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"WHO: RAEB-2~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 15.9 months and high range of 'does not exist'.~Conventional Care: low range of 8.8 and high range of 19.4 months."||||0.0692
70917816|NCT00071799|141326556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"WHO: Other~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 15.6 months and high range of 'does not exist'.~Conventional Care: low range of 11.1 and high range of 17.5 months."||||0.0017
70917817|NCT00071799|141326556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.103||95.0||||"95% CI ranges are added here.~Azacitidine: low range of 17.1 months and high range of 'does not exist'.~Conventional Care: low range of 8.7 and high range of 24.1 months."|Log Rank|The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification.||IPSS: Intermediate 2 All patients were stratified at randomization by FAB classification and IPSS score as determined by the investigator using centrally read bone marrow and cytogenetic data. Subsequently, the FAB classifications and IPSS scores were reviewed by an Independent Review Committee (IRC). The subgroup analyses presented by FAB and IPSS represent the FAB classification and IPSS scores as determined by the IRC.||||0.1030
70917818|NCT00071799|141326556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"95% CI ranges are added here.~Azacitidine: low range of 15.0 months and high range of 'does not exist'.~Conventional Care: low range of 9.0 and high range of 17.0 months."|Log Rank|The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification||IPSS: High All patients were stratified at randomization by FAB classification and IPSS score as determined by the investigator using centrally read bone marrow and cytogenetic data. Subsequently, the FAB classifications and IPSS scores were reviewed by an Independent Review Committee (IRC). The subgroup analyses presented by FAB and IPSS represent the FAB classification and IPSS scores as determined by the IRC.||||0.0020
70917819|NCT00071799|141326557|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0025||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification.|Log Rank|||||||0.0025
70917820|NCT00071799|141326557|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.68||||0.0027|TWO_SIDED|95.0|0.53|0.87|||Regression, Cox||Cox proportional hazards model stratified on the randomization factors of FAB and IPSS with model term of treatment.|||0.87|0.53|0.0027
70917821|NCT00071799|141326558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2555||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||||||0.2555
70917822|NCT00071799|141326558|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.83||||0.2562|TWO_SIDED|95.0|0.6|1.15|||Regression, Cox||Cox proportional hazards model stratified on the randomization factors of FAB and IPSS with model term of treatment.|||1.15|0.60|0.2562
70917823|NCT00071799|141326559|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Fisher Exact|||The p value is from Fisher's exact test comparing the difference in the azacitidine group and the combined group of CCR regimens among patients who were transfusion dependent at baseline and transfusion independent during the on-treatment period.||||<0.0001
70917824|NCT00071799|141326560|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||95.0|||||Fisher Exact|||The p value is from Fisher's exact test comparing the difference in the azacitidine group and the combined group of CCR regimens among patients who were transfusion independent at baseline and remained transfusion independent during the on-treatment period.||||0.0005
70917825|NCT00071799|141326561|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Fisher Exact|||The p value is from Fisher's exact test comparing the difference in the azacitidine group and the combined group of CCR regimens among patients who were transfusion dependent at baseline and transfusion independent during the on-treatment period||||1.000
70917826|NCT00071799|141326562|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Fisher Exact|||The p value is from Fisher's exact test comparing the difference in the azacitidine group and the combined group of CCR regimens among patients who were transfusion independent at baseline and remained transfusion independent during the on-treatment period.||||<0.0001
70917827|NCT00071799|141326563|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||Fisher Exact|||Overall (Complete + Partial Remission)||||0.0001
70917828|NCT00071799|141326563|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||95.0|||||Fisher Exact|||Complete remission||||0.0150
70917829|NCT00071799|141326563|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0094||95.0|||||Fisher Exact|||Partial Remission||||0.0094
70917830|NCT00071799|141326563|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3297||95.0|||||Fisher Exact|||Stable Disease||||0.3297
70917831|NCT00071799|141326564|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Fisher Exact|||Any Improvement||||<0.0001
70917832|NCT00071799|141326564|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Fisher Exact|||Erythroid Response - Major||||<0.0001
70917833|NCT00071799|141326564|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6203||95.0|||||Fisher Exact|||Erythroid Response - Minor||||0.6203
70917834|NCT00071799|141326564|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0|||||Fisher Exact|||Platelet Response - Major||||0.0003
70917835|NCT00071799|141326564|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7514||95.0|||||Fisher Exact|||Platelet Response - Minor||||0.7514
70917836|NCT00071799|141326564|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8695||95.0|||||Fisher Exact|||Neutrophil Response - Major||||0.8695
70917837|NCT00071799|141326564|SUPERIORITY_OR_OTHER_LEGACY|||||||0.176||95.0|||||Fisher Exact|||Neutrophil Response - Minor||||0.1760
71153939|NCT00488683|141800066|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup A||||
70917838|NCT00071799|141326565|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0466||95.0||||The p value is two-sided from the log rank test which compares whether the azacitidine and control group follow the same duration curve.|Log Rank|||||||0.0466
70917839|NCT00071799|141326565|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.0474|TWO_SIDED|95.0|0.53|1.0|||Regression, Cox|||||1.00|0.53|0.0474
70917840|NCT00071799|141326566|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0||||The p value is two-sided from the log rank test which compares whether the azacitidine and control group follow the same duration curve.|Log Rank|||||||0.0002
70917841|NCT00071799|141326567|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.67||||0.1327|TWO_SIDED|95.0|0.35|1.2|||exact binomial|||||1.20|0.35|0.1327
70917842|NCT00071799|141326569|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||||||<0.0001
70917843|NCT00071799|141326569|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.35|0.7|||Regression, Cox||Cox proportional hazards model stratified on the randomization factors of FAB and IPSS with model term of treatment.|||0.70|0.35|<0.0001
70917844|NCT03593213|141326578|SUPERIORITY||Hazard Ratio (HR)|0.56|||=|0.1576|TWO_SIDED|95.0|0.25|1.29||The significance level was 0.05 using the log rank test.|Log Rank||Hazard ratio (cariprazine 3.0 or 4.5 mg/day vs. placebo) was based on Cox proportional hazards regression model, with treatment group as an explanatory variable.|||1.29|0.25|=0.1576
70917845|NCT03593213|141326578|SUPERIORITY||Hazard Ratio (HR)|0.61|||=|0.2066|TWO_SIDED|95.0|0.26|1.45||The significance level was 0.05 using the log rank test.|Log Rank||Hazard ratio (cariprazine 3.0 or 4.5 mg/day vs. placebo) was based on Cox proportional hazards regression model, with treatment group as an explanatory variable.|||1.45|0.26|=0.2066
70917846|NCT01254019|141326581|SUPERIORITY||Mean Difference (Net)|10.334||||0.415|TWO_SIDED|95.0|-14.645|35.312||Statistical significance was assessed at the 5% level.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||35.312|-14.645|0.415
70917847|NCT01254019|141326582|SUPERIORITY||Mean Difference (Net)|-0.53||||0.757|TWO_SIDED|95.0|-3.95|2.88||Statistical significance (SS) was only to be assessed if a statistically significant difference was observed for the primary and any secondary endpoints higher in the pre-defined hierarchy. Hence conclusions with regards to SS should not be made.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||2.88|-3.95|0.757
70917848|NCT01254019|141326583|SUPERIORITY||Mean Difference (Net)|-0.021||||0.718|TWO_SIDED|95.0|-0.137|0.095||SS was only to be assessed if a statistically significant difference was observed for the primary and any secondary endpoints higher in the pre-defined hierarchy. Hence conclusions with regards to SS should not be made.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||0.095|-0.137|0.718
70917849|NCT01254019|141326584|SUPERIORITY||Mean Difference (Net)|-0.009||||0.881|TWO_SIDED|95.0|-0.129|0.111||SS was only to be assessed if a statistically significant difference was observed for the primary and any secondary endpoints higher in the pre-defined hierarchy. Hence conclusions with regards to SS should not be made.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||0.111|-0.129|0.881
70917850|NCT01254019|141326585|SUPERIORITY||Mean Difference (Net)|-1.115||||0.658|TWO_SIDED|95.0|-6.097|3.866||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||3.866|-6.097|0.658
70917851|NCT01254019|141326586|SUPERIORITY||Mean Difference (Net)|0.041||||0.513|TWO_SIDED|95.0|-0.082|0.164||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||0.164|-0.082|0.513
71153940|NCT00488683|141800066|SUPERIORITY_OR_OTHER||R-square|0.007||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup C||||
70917852|NCT01254019|141326587|SUPERIORITY||Mean Difference (Net)|-0.965||||0.769|TWO_SIDED|95.0|-7.446|5.516||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||5.516|-7.446|0.769
70917853|NCT01254019|141326590|SUPERIORITY||Mean Difference (Net)|-4044.99||||0|TWO_SIDED|95.0|-5232.21|-2857.77||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||-2857.77|-5232.21|0.000
70917854|NCT01254019|141326596|SUPERIORITY||Mean Difference (Net)|0.0288||||0.207|TWO_SIDED|95.0|-0.0161|0.0738||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo, HUI2 at Week 48||0.0738|-0.0161|0.207
70917855|NCT01254019|141326596|SUPERIORITY||Mean Difference (Net)|0.0048||||0.88|TWO_SIDED|95.0|-0.058|0.0676||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo, HUI3 at Week 48||0.0676|-0.0580|0.880
70917856|NCT01240330|141326633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.9|STANDARD_DEVIATION|7.46|<|0.0001|TWO_SIDED|95.0|16.3|21.59|||t-test, 1 sided|||The femoral venous peak flow velocity (PFV) compared to the subject's own resting baseline PFV.||21.59|16.30|<0.0001
70917857|NCT03260140|141326636|SUPERIORITY||Mean Difference (Final Values)|-1.93||||0.001|TWO_SIDED|97.5|-3.24|-0.61|||Mixed Models Analysis|Difference in average weight at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average 12-month weight between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||-0.61|-3.24|0.001
70917858|NCT03260140|141326637|SUPERIORITY||Mean Difference (Final Values)|0.69||||0.388|TWO_SIDED|97.5|-1.11|2.49|||Mixed Models Analysis|Difference in average SF-12 PCS score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the 12-month SF-12 PCS between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||2.49|-1.11|0.388
70917859|NCT03260140|141326638|SUPERIORITY||Sign test|1.76||||0.308|TWO_SIDED|95.0|0.85|3.66|||F test-ratio of 2 McNemar's Chi-Squares|||Group-specific McNemar's Chi-Square tests were applied to examine the change from baseline to follow-up in dichotomized IPAQ (\>=150 vs \<150) minutes of physical activity per week. To compare intervention vs. control at 12 months, we applied an F test. The intervention effect was an odds ratio of the ratios of discordant pairs in the intervention vs the control group.||3.66|0.85|0.308
70917860|NCT03260140|141326639|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.396|TWO_SIDED|95.0|-0.61|0.24|||Mixed Models Analysis|Difference in average weight at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average 12-month score between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||0.24|-0.61|0.396
70917861|NCT03260140|141326640|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.657|TWO_SIDED|95.0|-1.02|1.61|||Mixed Models Analysis|Difference in average score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average 12-month score between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||1.61|-1.02|0.657
70917862|NCT03260140|141326641|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.281|TWO_SIDED|95.0|-2.33|0.68|||Mixed Models Analysis|Difference in average score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average 12-month score between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||0.68|-2.33|0.281
71153941|NCT00488683|141800066|SUPERIORITY_OR_OTHER||R-square|0.04||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup C||||
70917863|NCT03260140|141326642|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.483|TWO_SIDED|95.0|-0.11|0.23|||Mixed Models Analysis|Difference in average score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rodgers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average score between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||0.23|-0.11|0.483
71153942|NCT00488683|141800066|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||
70917864|NCT03260140|141326643|SUPERIORITY||Mean percent change in HbA1c|0.02||||0.985|TWO_SIDED|95.0|-2.57|2.69|||Mixed Models Analysis|Difference in average HbA1c at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis on log-transformed HbA1c comparing the average HbA1c between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||2.69|-2.57|0.985
70917865|NCT03260140|141326644|SUPERIORITY||Mean Difference (Net)|-0.22||||0.806|TWO_SIDED|95.0|-1.99|1.55|||Mixed Models Analysis|Difference in average SF-12 MCS score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average 12-month MCS between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||1.55|-1.99|0.806
70917866|NCT03260140|141326645|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.62|TWO_SIDED|95.0|-1.77|1.05|||Mixed Models Analysis|Difference in average DBP at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average 12-month DBP between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||1.05|-1.77|0.620
70917867|NCT03260140|141326646|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.987|TWO_SIDED|95.0|-2.32|2.28|||Mixed Models Analysis|Difference in average SPB at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average SBP between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||2.28|-2.32|0.987
70917868|NCT01444417|141326647|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.0497||||0.0018|TWO_SIDED|95.0|1.896|43.199|||Cochran-Mantel-Haenszel|P-value from Cochran-Mantel-Haenszel test stratified by baseline age group.||The incidence of durable platelet response was compared by the Cochran-Mantel-Haenszel test stratified by the baseline age group. The Mantel-Haenszel common odds ratio (romiplostim vs placebo) was estimated along with its 95% confidence interval.||43.199|1.896|0.0018
70917869|NCT01444417|141326648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.0443||||0.0002|TWO_SIDED|95.0|2.535|32.265|||Cochran-Mantel-Haenszel|P-value from Cochran-Mantel-Haenszel test stratified by baseline age group.||The incidence of overall platelet response was compared by the Cochran-Mantel-Haenszel test stratified by the baseline age group. The Mantel-Haenszel common odds ratio (romiplostim vs placebo) was estimated along with its 95% confidence interval.||32.265|2.535|0.0002
70917870|NCT01444417|141326649|SUPERIORITY_OR_OTHER|||||||0.0004|||||||ANOVA|P-value from Analysis of Variance with main effects (treatment and age group) model after testing for non-significant interaction (p-value ≥ 0.10).||||||0.0004
70917871|NCT01444417|141326650|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.813||||0.7103|TWO_SIDED|95.0|0.277|2.391|||Cochran-Mantel-Haenszel|P-value from Cochran-Mantel-Haenszel test stratified by baseline age group||||2.391|0.277|0.7103
70917872|NCT01214824|141326664|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.3||||0.014||95.0|||||Wilcoxon signed rank test|||Comparison is HbA1c at 6 months versus Baseline||||0.014
70917873|NCT01214824|141326666|SUPERIORITY_OR_OTHER|||||||0.5304||95.0|||||Paired t-test|||Comparison is masked phase 2 versus masked phase 1||||0.5304
70917874|NCT03505099|141326716|SUPERIORITY||Difference of Proportion|76.5|||<|0.0001|TWO_SIDED|95.0|50.95|92.21|||Fisher Exact||||Data for the current study were compared to historical control data (Finkel et al, 2014 - PubMed 25080519) where 19 out of 81 participants (23.46%) with 3 copies of SMN2 achieved standing alone for at least 3 seconds.|92.21|50.95|<0.0001
70917875|NCT03505099|141326717|SUPERIORITY||Difference of Proportion|73.9|||<|0.0001|TWO_SIDED|95.0|44.67|91.61|||Fisher Exact||||Data for the current study were compared to historical control data (Finkel et al 2014 - PubMed 25080519) where 6 out of 23 participants (26.09%) with 2 copies of SMN2 were alive and did not require permanent ventilation.|91.61|44.67|<0.0001
70917876|NCT03505099|141326719|SUPERIORITY||Difference of Proportion|72.3|||<|0.0001|TWO_SIDED|95.0|44.9|90.11|||Fisher Exact||||Data for the current study were compared to historical control data (Finkel et al, 2014 - PubMed 25080519) where 17 out of 81 participants (20.99%) with 3 copies of SMN2 achieved the ability to walk alone.|90.11|44.90|<0.0001
70917877|NCT00696618|141326733|SUPERIORITY_OR_OTHER||||||<|0.05||||||Adjusted for multiple comparisons.|multi-level|||Nine research participants provided the ability to detect an effect size of 1.25 standard deviation units relative to the mean with 80% power using two-sided, 5% alpha in a paired analysis. The Baseline condition (no intervention) was assigned a value of 1 and geometric mean ratios with 95% confidence intervals for each intervention were calculated relative to baseline.||||<.05
70917878|NCT00696618|141326734|SUPERIORITY_OR_OTHER||||||<|0.05|||||||multi-level|||||||<.05
70917879|NCT00696618|141326735|SUPERIORITY_OR_OTHER||||||<|0.05|||||||mulit-level analysis|||||||<.05
70917880|NCT00688519|141326736|SUPERIORITY_OR_OTHER|||||||0.058|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.058
70917881|NCT00688519|141326736|SUPERIORITY_OR_OTHER|||||||0.313|||||||Breslow-Day Test|Breslow-Day test of the homogeneity of the odds ratio using a 0.1 significance level.||Consistency of results across investigative centers was verified using the Breslow-Day test of homogeneity the odds ration using a significance level of 0.1||||0.313
70917882|NCT00688519|141326737|SUPERIORITY_OR_OTHER|||||||0.029|||||||Cochran-Mantel-Haenszel|||These P-values are provided for information purposes only; they are considered non-significant (per the statistical analysis plan) because the analysis of the primary end point did not reach statistical significance.||||0.029
70917883|NCT00688519|141326738|SUPERIORITY_OR_OTHER|||||||0.013|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||These P-values are provided for information purposes only; they are considered non-significant (per the statistical analysis plan) because the analysis of the primary end point did not reach statistical significance.||||0.013
70917884|NCT00688519|141326739|SUPERIORITY_OR_OTHER|||||||0.008|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||These P-values are provided for information purposes only; they are considered non-significant (per the statistical analysis plan) because the analysis of the primary end point did not reach statistical significance.||||0.008
70917885|NCT00688519|141326740|SUPERIORITY_OR_OTHER|||||||0.018|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||These P-values are provided for information purposes only; they are considered non-significant (per the statistical analysis plan) because the analysis of the primary end point did not reach statistical significance.||||0.018
70917886|NCT00688519|141326741|SUPERIORITY_OR_OTHER|||||||0.167|||||||Cochran-Mantel-Haenszel|stratified by pooled center||Comparison of calcipotriene foam and vehicle foam for patients who had mild disease at baseline||||0.167
70917887|NCT00688519|141326741|SUPERIORITY_OR_OTHER|||||||0.009|||||||Cochran-Mantel-Haenszel|stratified by pooled center||Comparison of calcipotriene foam and vehicle foam for patients who had moderate disease at baseline||||0.009
70917888|NCT00940537|141326743|SUPERIORITY_OR_OTHER|||||||0.097||95.0||||a priori threshhold for significance was set at p\<0.05.|t-test, 2 sided|this was a paired t-test||As there was no a priori reason for the level of IHTG to impact this measurement we compared the pre and post-prandial results for all subjects whose data were of sufficient quality (N=12). These results are comparing the two categories of fasting and post-prandial. Null hypothesis was that there would be no difference in IHTG before and after a high fat, high carbohydrate meal.||||.097
70917889|NCT00940537|141326744|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||This p-value compares the low IHTG (\<5%) subjects to those with medium levels of IHTG (5 - 10%). The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||null hypothesis was that the T2 ratio would not depend on level of intrahepatic triglyceride (IHTG) and would be equal for the low and medium IHTG categories.||||0.006
70917890|NCT00940537|141326744|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||null hypothesis was that the T2 ratio would not depend on level of intra-hepatic triglyceride (IHTG) and would be equal for the low (\<5%) and high (\>10%) IHTG categories.||||<0.0001
70917891|NCT00940537|141326744|SUPERIORITY_OR_OTHER|||||||0.93||95.0||||The a priori threshold for statistical significance was set at p\<0.05.|t-test, 2 sided|||The null hypothesis was that there would be no difference in T2 relaxation ratios for varying levels of intra-hepatic triglyceride (IHTG). Thus the medium (5 - 10%) and high (\<10%) IHTG groups would not be statistically different with regard to average T2 ratio.||||.93
70970778|NCT00105443|141447207|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0764||||0.7676||95.0|0.8837|1.311|||Log Rank||This is the sorafenib to placebo hazard ratio.|"The 2 arms were compared using a 1-sided log-rank test with an overall alpha of 0.005 stratified by region, ECOG PS and tumor burden. This was a co-primary endpoint with overall survival. No alpha-spending adjustments were necessary as it was only to be analyzed at the end of study."||1.3110|0.8837|0.7676
70970779|NCT00105443|141447208|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5764||||7e-06||95.0|0.4484|0.741|||Log Rank||This is the sorafenib to placebo hazard ratio.|"In the analysis of TTP, based on independent radiological review performed to review data up to 12 May 2006, the 2 treatment groups were compared using a 1-sided log rank test with an alpha of 0.025, stratified by region, ECOG PS, and tumor burden."||0.7410|0.4484|0.000007
70917892|NCT04036058|141326775|SUPERIORITY|||||||0.611|||||||t-test, 2 sided|||||||0.611
70917893|NCT04036058|141326776|SUPERIORITY|||||||0.0435|||||||t-test, 2 sided|||||||0.0435
70917894|NCT04036058|141326777|SUPERIORITY|||||||0.1158|||||||t-test, 2 sided|||||||0.1158
70917895|NCT04036058|141326778|SUPERIORITY|||||||0.0898|||||||t-test, 2 sided|||||||0.0898
70917896|NCT04036058|141326779|SUPERIORITY|||||||0.114|||||||t-test, 2 sided|||||||0.114
70917897|NCT02999477|141326786|EQUIVALENCE|The null hypothesis is no change in the amount of PD-L1 expression from baseline to after a two-week run in of nabpaclitaxel. The test was using one-sided alpha (type I error) of 0.05. The margin is zero.||||||1|||||||McNemar|||||||1.0
70917898|NCT02999477|141326786|EQUIVALENCE|The null hypothesis is no change in the amount of PD-L1 expression from baseline to after a two-week run in of nabpaclitaxel or pembrolizumab. The test was using one-sided alpha (type I error) of 0.05.||||||1|||||||McNemar|||||||1.0
70917899|NCT03351075|141326802|SUPERIORITY||Mean Difference (Net)|-1.31||||0.5163|TWO_SIDED|95.0|-5.28|2.65||No corrections for multiple testing were performed.|Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||The sample size was based on comparing the changes for the primary outcome measure (PDI-DLV) at 12 months after surgery. The calculation was based on comparing the values at 12 months. Assuming a coefficient of variation (CV) equal to 0.5, 87 participants per group were needed based on a two-sample pooled t-test of a mean ratio with lognormal data and α=0.05 to detect with 80% power a difference of 20% in PDI. To anticipate a drop-out ratio of 5%, a total of 184 subjects were needed.||2.65|-5.28|0.5163
70917900|NCT03351075|141326803|SUPERIORITY||Mean Difference (Net)|-0.97||||0.5655|TWO_SIDED|95.0|-4.26|2.33||No corrections for multiple testing were performed.|multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain-related disability from baseline to 4 months||2.33|-4.26|0.5655
70917901|NCT03351075|141326803|SUPERIORITY||Mean Difference (Net)|-1.07||||0.5592|TWO_SIDED|95.0|-4.64|2.51||P\<.05 was considered significant. No corrections for multiple testing were performed.|multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain-related disability from baseline to 1.5 years||2.51|-4.64|0.5592
70917902|NCT03351075|141326804|SUPERIORITY||Mean Difference (Net)|-2.23||||0.563|TWO_SIDED|95.0|-9.84|5.37||No corrections for multiple testing were performed.|Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain intensity from baseline to 4 months||5.37|-9.84|0.5630
70917903|NCT03351075|141326804|SUPERIORITY||Mean Difference (Net)|-4.3||||0.2524|TWO_SIDED|95.0|-11.68|3.09||No corrections for multiple testing were performed.|Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain intensity from baseline to 12 months||3.09|-11.68|0.2524
70917904|NCT03351075|141326804|SUPERIORITY||Mean Difference (Net)|-4.8||||0.2315|TWO_SIDED|95.0|-12.69|3.09|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain intensity from baseline to 1.5 years||3.09|-12.69|0.2315
70917905|NCT03351075|141326805|SUPERIORITY||Mean Difference (Net)|0.47||||0.7494|TWO_SIDED|95.0|-2.39|3.32||No corrections for multiple testing were performed.|Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported central sensitisation symptoms from baseline to 4 months.||3.32|-2.39|0.7494
70917906|NCT03351075|141326805|SUPERIORITY||Mean Difference (Net)|-0.25||||0.8617|TWO_SIDED|95.0|-3.09|2.58|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||The difference in change in self-reported central sensitisation symptoms from baseline to 12 months.||2.58|-3.09|0.8617
70917907|NCT03351075|141326805|SUPERIORITY||Mean Difference (Net)|-0.29||||0.8454|TWO_SIDED|95.0|-3.16|2.59|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported central sensitisation symptoms from baseline to 1.5 years||2.59|-3.16|0.8454
70917908|NCT03351075|141326806|SUPERIORITY||Mean Difference (Net)|1.35||||0.3463|TWO_SIDED|95.0|0.72|2.51|||multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in mechanical detection sensitivity at the arm from baseline to 4 months||2.51|0.72|0.3463
70917909|NCT03351075|141326806|SUPERIORITY||Mean Difference (Net)|0.86||||0.6613|TWO_SIDED|95.0|0.451|1.66|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in mechanical detection sensitivity at the arm from baseline to 1 year||1.66|0.451|0.6613
70917910|NCT03351075|141326806|SUPERIORITY||Mean Difference (Net)|1.26||||0.4908|TWO_SIDED|95.0|0.65|2.42|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in mechanical detection sensitivity at the arm from baseline to 1.5 years||2.42|0.65|0.4908
70917911|NCT03351075|141326807|SUPERIORITY||Mean Difference (Net)|0.22||||0.7708|TWO_SIDED|95.0|-1.25|1.69|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in warmth detection sensitivity from baseline to 4 months||1.69|-1.25|0.7708
70970780|NCT00105443|141447209|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-11.95||||0.001641||95.0|-19.56|-4.35|||Cochran-Mantel-Haenszel||Sorafenib minus placebo difference|"Disease control rates were compared between treatment groups using the Cochran Mantel Haenszel (CMH) test with a 1-sided alpha of 0.025, adjusting for region, ECOG PS, and tumor burden."||-4.35|-19.56|0.001641
70917912|NCT03351075|141326807|SUPERIORITY||Mean Difference (Net)|0.29||||0.706|TWO_SIDED|95.0|-1.23|1.81|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in warmth detection sensitivity from baseline to 1 year||1.81|-1.23|0.7060
70917913|NCT03351075|141326807|SUPERIORITY||Mean Difference (Net)|0.02||||0.9806|TWO_SIDED|95.0|-1.38|1.42|||Multivariate linear model|||Difference in change in warmth detection sensitivity from baseline to 1.5 years||1.42|-1.38|0.9806
70917914|NCT03351075|141326808|SUPERIORITY||Mean Difference (Net)|0.74||||0.0284|TWO_SIDED|95.0|0.08|1.4|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome||Difference in change in wind-up from baseline to 4 months||1.40|0.08|0.0284
70917915|NCT03351075|141326808|SUPERIORITY||Mean Difference (Net)|0.09||||0.7776|TWO_SIDED|95.0|-0.55|0.73|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome||Difference in change in wind-up from baseline to 1 year||0.73|-0.55|0.7776
70917916|NCT03351075|141326808|SUPERIORITY||Mean Difference (Net)|0.31||||0.3829|TWO_SIDED|95.0|-0.39|1.01|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome||Difference in change in wind-up from baseline to 1.5 years||1.01|-0.39|0.3829
70917917|NCT03351075|141326809|SUPERIORITY||Mean Difference (Net)|0.31||||0.1948|TWO_SIDED|95.0|-0.16|0.77|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in conditioned pain modulation from baseline to 4 months||0.77|-0.16|0.1948
70917918|NCT03351075|141326809|SUPERIORITY||Mean Difference (Net)|0.17||||0.4937|TWO_SIDED|95.0|-0.31|0.65|||Multivariate linear model|||Difference in change in conditioned pain modulation from baseline to 1 year||0.65|-0.31|0.4937
70917919|NCT03351075|141326809|SUPERIORITY||Mean Difference (Net)|0.23||||0.369|TWO_SIDED|95.0|-0.27|0.73|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in conditioned pain modulation from baseline to 1.5 years||0.73|-0.27|0.3690
70917920|NCT03351075|141326810|SUPERIORITY||Mean Difference (Net)|2.24||||0.2915|TWO_SIDED|95.0|-1.94|6.43|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported upper limb function from baseline to 4 months||6.43|-1.94|0.2915
70917921|NCT03351075|141326810|SUPERIORITY||Mean Difference (Net)|-1.63||||0.4632|TWO_SIDED|95.0|-6.02|2.75|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported upper limb function from baseline to 1 year||2.75|-6.02|0.4632
71093159|NCT00569127|141693521|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.55|TWO_SIDED|95.0|0.73|1.18||Central-review based progression-free survival was analyzed using the stratified log rank test (which is the score test from the stratified Cox-model) using stratification factors as defined in Section 6.0.|Regression, Cox||The reported hazard ratio estimate is for the comparison of the Octreotide, Bevacizumab arm to the Octreotide, Interferon Alpha-2b arm.|According to the intent-to-treat principle, all eligible patients were included in the analysis according to the randomized treatment assignment, regardless of actual treatments received.||1.18|0.73|0.55
70917922|NCT03351075|141326810|SUPERIORITY||Mean Difference (Net)|-3.16||||0.1944|TWO_SIDED|95.0|-7.94|1.63|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported upper limb function from baseline to 1,5 years||1.63|-7.94|0.1944
70917923|NCT03351075|141326811|SUPERIORITY||Mean Difference (Net)|-293.0||||0.5332|TWO_SIDED|95.0|-1218.0|632.0|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in step count from baseline to 4 months||632|-1218|0.5332
70917924|NCT03351075|141326811|SUPERIORITY||Mean Difference (Net)|839.0||||0.1201|TWO_SIDED|95.0|-221.0|1900.0|||Multivariate linear model|||Difference in change in step count from baseline to 1 year||1900|-221|0.1201
70917925|NCT03351075|141326812|SUPERIORITY||Mean Difference (Net)|0.831||||0.359|TWO_SIDED|95.0|0.561|1.233|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain catastrophizing from baseline to 4 months||1.233|0.561|0.3590
70917926|NCT03351075|141326812|SUPERIORITY||Mean Difference (Net)|0.839||||0.3744|TWO_SIDED|95.0|0.57|1.236|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain catastrophizing from baseline to 1 year||1.236|0.570|0.3744
70917927|NCT03351075|141326812|SUPERIORITY||Median Difference (Net)|0.848||||0.4533|TWO_SIDED|95.0|0.522|1.304|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain catastrophizing from baseline to 1.5 years||1.304|0.522|0.4533
70917928|NCT03351075|141326813|SUPERIORITY||Mean Difference (Net)|0.862||||0.5018|TWO_SIDED|95.0|0.558|1.33|||MUltivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported depression from baseline to 4 months||1.330|0.558|0.5018
70917929|NCT03351075|141326813|SUPERIORITY||Mean Difference (Net)|0.808||||0.3362|TWO_SIDED|95.0|0.522|1.248|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported depression from baseline to 1 year||1.248|0.522|0.3362
70917930|NCT03351075|141326813|SUPERIORITY||Mean Difference (Net)|0.958||||0.8375|TWO_SIDED|95.0|0.633|1.449|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported depression from baseline to 1.5 years||1.449|0.633|0.8375
71093160|NCT06442800|141693526|SUPERIORITY||Mean Difference (Final Values)|1.31|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Multiple cancers vs. Control||||<0.001
70917931|NCT03351075|141326814|SUPERIORITY||Mean Difference (Net)|-0.32||||0.1745|TWO_SIDED|95.0|-0.78|0.14|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported health-related quality of life from baseline to 4 months||0.14|-0.78|0.1745
70917932|NCT03351075|141326814|SUPERIORITY||Mean Difference (Net)|0.18||||0.5025|TWO_SIDED|95.0|-0.35|0.71|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported health-related quality of life from baseline to 1 year||0.71|-0.35|0.5025
70917933|NCT03351075|141326814|SUPERIORITY||Mean Difference (Net)|0.45||||0.1363|TWO_SIDED|95.0|-0.14|1.05|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported health-related quality of life from baseline to 1,5 years||1.05|-0.14|0.1363
70917934|NCT03351075|141326815|SUPERIORITY||Percentage|-0.184||||0.074|TWO_SIDED|95.0|-0.358|0.008|||Fisher Exact|||Difference in proportion of working participants at 1 year||0.008|-0.358|0.074
70917935|NCT03351075|141326815|SUPERIORITY||Percentage|-0.09||||0.352|TWO_SIDED|95.0|-0.26|0.078|||Fisher Exact|||Difference in proportion of working participants at 1,5 years||0.078|-0.26|0.352
70917936|NCT03351075|141326816|SUPERIORITY||Mean Difference (Net)|0.23||||0.8497|TWO_SIDED|95.0|-2.17|2.64|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in cold detection sensitivity from baseline to 4 months||2.64|-2.17|0.8497
70917937|NCT03351075|141326816|SUPERIORITY||Mean Difference (Net)|0.81||||0.4971|TWO_SIDED|95.0|-1.52|3.14|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in cold detection sensitivity from baseline to 1 year||3.14|-1.52|0.4971
70917938|NCT03351075|141326816|SUPERIORITY||Mean Difference (Net)|0.45||||0.6831|TWO_SIDED|95.0|-1.72|2.62|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in cold detection sensitivity from baseline to 1.5 years||2.62|-1.72|0.6831
70917939|NCT03351075|141326817|SUPERIORITY||Mean Difference (Net)|4.78||||0.8584|TWO_SIDED|95.0|-47.72|57.28|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in mechanical pain sensitivity at the arm from baseline to 4 months||57.28|-47.72|0.8584
71093161|NCT06442800|141693526|SUPERIORITY||Mean Difference (Final Values)|1.19|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Dementia vs. Control||||<0.001
71093162|NCT06442800|141693526|SUPERIORITY||Mean Difference (Final Values)|1.17|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Colorectal cancer vs. Control||||<0.001
71093163|NCT06442800|141693526|SUPERIORITY||Mean Difference (Final Values)|1.15|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Liver cancer vs. Control||||<0.001
70917940|NCT03351075|141326817|SUPERIORITY||Mean Difference (Net)|-57.25||||0.0353|TWO_SIDED|95.0|-110.57|-3.93|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in mechanical pain sensitivity at the arm from baseline to 1 year||-3.93|-110.57|0.0353
70917941|NCT03351075|141326817|SUPERIORITY||Mean Difference (Net)|-20.1||||0.4865|TWO_SIDED|95.0|-76.72|36.52|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in mechanical pain sensitivity at the arm from baseline to 1.5 years||36.52|-76.72|0.4865
70917942|NCT03351075|141326818|SUPERIORITY||Mean Difference (Net)|1.11||||0.1278|TWO_SIDED|95.0|0.97|1.27|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in pressure pain sensitivity at the pectoral region from baseline to 4 months||1.27|0.97|0.1278
70917943|NCT03351075|141326818|SUPERIORITY||Mean Difference (Net)|1.11||||0.1875|TWO_SIDED|95.0|0.95|1.3|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in pressure pain sensitivity at the pectoral region from baseline to 1 year||1.30|0.95|0.1875
70917944|NCT03351075|141326818|SUPERIORITY||Mean Difference (Net)|1.05||||0.5612|TWO_SIDED|95.0|0.89|1.23|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in pressure pain sensitivity at the pectoral region from baseline to 1.5 years||1.23|0.89|0.5612
70917945|NCT03351075|141326819|SUPERIORITY||Mean Difference (Net)|1.089||||0.7902|TWO_SIDED|95.0|0.693|1.62|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported anxiety from baseline to 4 months||1.620|0.693|0.7902
70917946|NCT03351075|141326819|SUPERIORITY||Mean Difference (Net)|0.934||||0.7578|TWO_SIDED|95.0|0.604|1.443|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported anxiety from baseline to 1 year||1.443|0.604|0.7578
70917947|NCT03351075|141326819|SUPERIORITY||Mean Difference (Net)|1.01||||0.96|TWO_SIDED|95.0|0.679|1.504|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported anxiety from baseline to 1.5 years||1.504|0.679|0.9600
70917948|NCT03351075|141326820|SUPERIORITY||Mean Difference (Net)|1.068||||0.7619|TWO_SIDED|95.0|0.696|1.639|||Multivariate linear model|multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported stress from baseline to 4 months||1.639|0.696|0.7619
70917949|NCT03351075|141326820|SUPERIORITY||Mean Difference (Net)|1.087||||0.7169|TWO_SIDED|95.0|0.702|1.673|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported stress from baseline to 1 year||1.673|0.702|0.7169
70917950|NCT03351075|141326820|SUPERIORITY||Mean Difference (Net)|0.987||||0.9535|TWO_SIDED|95.0|0.639|1.525|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported stress from baseline to 1.5 years||1.525|0.639|0.9535
70917951|NCT02396316|141326828|SUPERIORITY_OR_OTHER||Difference of LS mean change|-4.9||||0.0644|TWO_SIDED|95.0|-10.2|0.3|||ANCOVA|||Point estimate, 95% CI and P-value were based on treatment difference of the LS mean changes using an ANCOVA model with treatment group and stage of NVG for randomization as fixed effects, baseline value as covariate. The superiority of aflibercept injection to sham injection was to be established if the upper limit of the two-sided 95% confidence interval for the difference (the aflibercept group minus the sham group) is less than 0.||0.3|-10.2|0.0644
70917952|NCT02396316|141326829|SUPERIORITY_OR_OTHER||MH adjusted difference|59.1|||||TWO_SIDED|95.0|37.0|81.2|||Mantel Haenszel|||The point estimate of the treatment difference (the aflibercept group minus the sham group) at Week 1 and its two-sided 95% confidence interval stratified by stage of NVG (as randomized) using Mantel-Haenszel weights.||81.2|37.0|
70917953|NCT00566735|141326831|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 1 sided|Degrees of freedom = 28||Independent t-test to assess differences between the placebo and galantamine groups in regard to pre- and post-ECT scores on the Delayed Memory Index (DMI).||||<0.05
70917954|NCT00925587|141326834|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin -0.5 g/dL|Mean Difference (Final Values)|-0.188|STANDARD_ERROR_OF_MEAN|0.122|||TWO_SIDED|95.0|-0.427|0.052|||||Darbepoetin alfa QM - Darbepoetin alfa Q2W|Power = 90% at sample size calculation||0.052|-0.427|
70917955|NCT04532528|141326916|OTHER|No formal hypotheses were tested.||||||0.9701|||||||Chi-squared|||||||0.9701
70917956|NCT04532528|141326917|OTHER|No formal hypotheses were tested.||||||0.7376|||||||Chi-squared|||At 3 months only||||0.7376
70970781|NCT01157078|141447230|SUPERIORITY_OR_OTHER||LS mean|-1.0|STANDARD_ERROR_OF_MEAN|1.08||0.349|TWO_SIDED|95.0|-3.14|1.11||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.11|-3.14|0.349
70970782|NCT01157078|141447231|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|STANDARD_ERROR_OF_MEAN|0.29||0.444|TWO_SIDED|95.0|0.75|1.92|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.92|0.75|0.444
71093164|NCT06442800|141693526|SUPERIORITY||Mean Difference (Final Values)|1.14|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Throat and mouth cancer vs. Control||||<0.001
71093165|NCT06442800|141693526|SUPERIORITY||Mean Difference (Final Values)|1.11|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Liver disease vs. Control||||<0.001
70917957|NCT04532528|141326917|OTHER|No formal hypotheses were tested.||||||0.1356|||||||Chi-squared|||At 6 months only||||0.1356
70917958|NCT04532528|141326917|OTHER|No formal hypotheses were tested.||||||0.68|||||||Chi-squared|||At 9 months only||||0.6800
70917959|NCT04532528|141326918|OTHER|No formal hypotheses were tested.||||||0.5777|||||||Chi-squared|||At 3 months only||||0.5777
70917960|NCT04532528|141326918|OTHER|No formal hypotheses were tested.||||||0.3313|||||||Chi-squared|||At 6 months only||||0.3313
70917961|NCT04532528|141326918|OTHER|No formal hypotheses was tested.||||||0.5697|||||||Chi-squared|||At 9 months only||||0.5697
70917962|NCT04532528|141326918|OTHER|No formal hypotheses were tested.||||||0.5135|||||||Chi-squared|||At 12 months only||||0.5135
70917963|NCT04532528|141326919|OTHER|No formal hypotheses were tested.||||||0.8509|||||||Chi-squared|||At 3 months only||||0.8509
70917964|NCT04532528|141326919|OTHER|No formal hypotheses were tested.||||||0.3302|||||||Chi-squared|||At 6 months only||||0.3302
70917965|NCT04532528|141326919|OTHER|No formal hypotheses was tested.||||||0.9005|||||||Chi-squared|||At 9 months only||||0.9005
70917966|NCT04532528|141326919|OTHER|No formal hypotheses were tested.||||||0.2789|||||||Chi-squared|||At 12 months only||||0.2789
70917967|NCT04532528|141326920|OTHER|No formal hypotheses were tested.||||||0.667|||||||Wilcoxon (Mann-Whitney)|||At 3 months only||||0.6670
71093166|NCT06442800|141693526|SUPERIORITY||Mean Difference (Final Values)|0.98|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Hypertension vs. Control||||<0.001
70917968|NCT04532528|141326920|OTHER|||||||0.1285|||||||Wilcoxon (Mann-Whitney)|||At 6 months only||||0.1285
70917969|NCT04532528|141326920|OTHER|No formal hypotheses was tested.||||||0.7151|||||||Wilcoxon (Mann-Whitney)|||At 9 months only||||0.7151
70917970|NCT04532528|141326920|OTHER|No formal hypotheses were tested||||||0.803|||||||Wilcoxon (Mann-Whitney)|||At 12 months only||||0.8030
70917971|NCT04589689|141326924|OTHER|||||||0.777||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3 months.||||0.777
70917972|NCT04589689|141326924|OTHER|||||||0.247||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month.||||0.247
70917973|NCT04589689|141326925|OTHER|||||||0.16||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3-month follow-up.||||0.160
70917974|NCT04589689|141326925|OTHER|||||||0.275||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.275
70917975|NCT04589689|141326926|OTHER|||||||0.509||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3-month follow-up.||||0.509
70917976|NCT04589689|141326926|OTHER|||||||0.61||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.610
70917977|NCT04589689|141326927|OTHER|||||||0.807||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3-month follow-up.||||0.807
70917978|NCT04589689|141326927|OTHER|||||||0.826||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.826
70917979|NCT04589689|141326928|OTHER|||||||0.076||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3-month follow-up.||||0.076
70917980|NCT04589689|141326928|OTHER|||||||0.747||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.747
70917981|NCT04589689|141326929|OTHER|||||||0.154||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3-month follow-up.||||0.154
70917982|NCT04589689|141326929|OTHER|||||||0.107||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.107
70917983|NCT04589689|141326930|OTHER|||||||0.445||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3-month follow-up.||||0.445
70917984|NCT04589689|141326930|OTHER|||||||0.543||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.543
70917985|NCT04589689|141326931|OTHER|||||||0.157||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.157
70917986|NCT03061474|141326932|SUPERIORITY|||||||0.6096|||||||ANCOVA|||||||0.6096
70917987|NCT03061474|141326942|SUPERIORITY|||||||0.648|||||||ANCOVA|||||||0.648
70917988|NCT03061474|141326943|SUPERIORITY|||||||0.6833|||||||ANCOVA|||||||0.6833
70917989|NCT03061474|141326944|SUPERIORITY|||||||0.4438|||||||ANCOVA|||||||0.4438
70917990|NCT03061474|141326945|SUPERIORITY|||||||0.7158|||||||ANCOVA|||||||0.7158
70917991|NCT03061474|141326946|SUPERIORITY|||||||0.93428359|||||||ANCOVA|||||||0.93428359
70917992|NCT03061474|141326947|SUPERIORITY|||||||0.9931|||||||ANCOVA|||||||0.9931
70917993|NCT03061474|141326948|SUPERIORITY|||||||0.3233|||||||Mixed Models Analysis|||||||0.3233
70917994|NCT03061474|141326949|SUPERIORITY|||||||0.1008|||||||Mixed Models Analysis|||||||0.1008
70917995|NCT03061474|141326950|SUPERIORITY|||||||0.0323|||||||Mixed Models Analysis|||||||0.0323
70917996|NCT00189202|141326977|EQUIVALENCE|Equivalence margin 8% plus or minus 4.||||||0.28|||||||Mantel Haenszel|||||||0.28
70917997|NCT00189202|141326978|OTHER|||||||0.7|||||||Kaplan-Meier|||||||0.70
70917998|NCT01039688|141326984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.14||0.0014|TWO_SIDED|95.0|-0.73|-0.18||A stepdown procedure was used to control for multiple comparisons. In order for the comparison of CP-690,550 5 mg to be statistically significant versus MTX, the comparison of CP-690,550 10 mg versus MTX had to be statistically significant.|ANCOVA|||||-0.18|-0.73|0.0014
70917999|NCT01039688|141326984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.14||0.0004|TWO_SIDED|95.0|-0.77|-0.23||A stepdown procedure was used to control for multiple comparisons. In order for the comparison of CP-690,550 5 mg to be statistically significant versus MTX, the comparison of CP-690,550 10 mg versus MTX had to be statistically significant.|ANCOVA|||||-0.23|-0.77|0.0004
70918000|NCT01039688|141326985|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.32|||<|0.0001|TWO_SIDED|95.0|6.81|19.82||A stepdown procedure was used to control for multiple comparisons. For comparison of 5 mg to be statistically significant, comparison of 10 mg to MTX in ACR70 and comparison of 5 mg to MTX in change from BL in mTSS had to be statistically significant|Normal approximation|||||19.82|6.81|<0.0001
71093167|NCT06442800|141693526|SUPERIORITY||Mean Difference (Final Values)|0.81|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Current warning vs. Control||||<0.001
70918001|NCT01039688|141326985|SUPERIORITY_OR_OTHER||Risk Difference (RD)|25.25|||<|0.0001|TWO_SIDED|95.0|18.51|31.99||A stepdown procedure was used to control for multiple comparisons. For comparison of 10 mg to MTX in ACR70 to be statistically significant, comparison of 10 mg to MTX in change from BL in mTSS had to be statistically significant|Normal approximation|||||31.99|18.51|<0.0001
70918002|NCT03844269|141327090|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||EEG data excluded if excessive noise (rejection of more than 30% of target trials due to voltage fluctuations greater than ± 100 μV deflections within an epoch) at the pre- or post-intervention assessment||||<0.05
70918003|NCT02384070|141327164|SUPERIORITY_OR_OTHER|||||||1||||||Analysis of the variance was used and Chi-square test for categorical variables. A sample size was calculated for a 95% confidence level and a power of 80%, assuming a 10% difference between groups.|ANOVA|||||||1
70918004|NCT02384070|141327164|SUPERIORITY_OR_OTHER|||||||1||||||The prior threshold for statistical significance was P \< 0.05|ANOVA|||||||1
70918005|NCT01755949|141327173|SUPERIORITY|||||||0.038|||||||t-test, 2 sided|||Baseline C-reactive protein vs day 28 C-reactive protein||||0.038
70918006|NCT01755949|141327173|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|||Baseline C-reactive protein vs day 28 C-reactive protein||||0.98
70918007|NCT01755949|141327173|SUPERIORITY|||||||0.072|||||||t-test, 2 sided|||difference between placebo and colchicine levels at day 28||||0.072
70918008|NCT01755949|141327174|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||placebo vs colchicine||||0.08
70918009|NCT05082935|141327184|SUPERIORITY||Mean Difference (Final Values)|0.048||||0.09|TWO_SIDED|95.0|-0.008|0.104|||ANCOVA|||||0.104|-0.008|0.09
70918010|NCT05082935|141327185|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.02|TWO_SIDED|95.0|0.02|0.29|||ANCOVA|||||0.29|0.02|0.02
70918011|NCT05082935|141327186|SUPERIORITY||Ratio of Means|-0.076||||0.03|TWO_SIDED|95.0|-0.145|-0.007|||ANCOVA|||||-0.007|-0.145|0.03
70918012|NCT05082935|141327187|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.38|TWO_SIDED|95.0|-0.04|0.09|||ANCOVA|||||0.09|-0.04|0.38
70918013|NCT05082935|141327188|SUPERIORITY||Mean Difference (Final Values)|0.096||||0.002|TWO_SIDED|95.0|0.04|0.16|||ANCOVA|||||0.16|0.04|0.002
70918014|NCT00566527|141327213|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -5. Values are shown as percentages.|Measles Response Rate (Arm 2 - Arm 3)|-0.91|||||TWO_SIDED|95.0|-2.82|0.87||||||Measles difference||0.87|-2.82|
71093168|NCT06442800|141693526|SUPERIORITY||Mean Difference (Final Values)|0.58|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Guidelines vs. Control||||<0.001
70918015|NCT00566527|141327213|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -5. Values are shown as percentages.|Mumps Response Rate (Arm 2 - Arm 3)|0.03|||||TWO_SIDED|95.0|-1.2|1.32||||||Mumps difference||1.32|-1.20|
70918016|NCT00566527|141327213|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -5. Values are shown as percentages.|Rubella Response Rate (Arm 2 - Arm 3)|-0.22|||||TWO_SIDED|95.0|-1.55|1.03||||||Rubella difference||1.03|-1.55|
70918017|NCT00566527|141327213|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -10. Values are shown as percentages.|Varicella Response Rate (Arm 2 - Arm 3)|0.0|||||TWO_SIDED|95.0|-1.28|1.1||||||Varicella difference||1.10|-1.28|
70918018|NCT00566527|141327214|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -5. Values are shown as percentages.|Measles Response Rate (Arm 1 - Arm 3)|-3.97|||||TWO_SIDED|95.0|-6.44|-1.87||||||Measles difference||-1.87|-6.44|
70918019|NCT00566527|141327214|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -5. Values are shown as percentages.|Mumps Response Rate (Arm 1 - Arm 3)|-0.35|||||TWO_SIDED|95.0|-1.71|1.01||||||Mumps difference||1.01|-1.71|
70918020|NCT00566527|141327214|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -5. Values are shown as percentages.|Rubella Response Rate (Arm 1 - Arm 3)|-0.15|||||TWO_SIDED|95.0|-1.34|1.09||||||Rubella difference||1.09|-1.34|
70918021|NCT00566527|141327214|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -10. Values are shown as percentages.|Varicella Response Rate (Arm 1 - Arm 3)|0.0|||||TWO_SIDED|95.0|-1.83|1.1||||||Varicella difference||1.10|-1.83|
70918022|NCT00457743|141327235|SUPERIORITY_OR_OTHER||Disease control Rate (percentage)|56.7||||||95.0|37.4|74.5|||||The disease control rate, defined as the percentage of subjects confirmed with CR, PR, and SD \>=10 weeks on study according to RECIST.|||74.5|37.4|
70918023|NCT00457743|141327237|SUPERIORITY_OR_OTHER||Objective Response Rate(percentage)|13.3||||||95.0|3.8|30.7|||||The subjects confirmed with complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).|||30.7|3.8|
70918024|NCT00457743|141327246|SUPERIORITY_OR_OTHER||CBR rate (percentage)|40.0||||||95.0|22.7|59.4|||||The clinical benefit response (CBR) rate, defined as the percentage of the subjects confirmed with CR, PR, or SD\>=22 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST).|||59.4|22.7|
70918025|NCT02079844|141327299|SUPERIORITY_OR_OTHER||LS Mean Difference|0.232|STANDARD_ERROR_OF_MEAN|0.7313||0.753|TWO_SIDED|95.0|-1.269|1.733||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA|||||1.733|-1.269|0.753
70918026|NCT02079844|141327299|SUPERIORITY_OR_OTHER||LS Mean Difference|0.133|STANDARD_ERROR_OF_MEAN|0.7417||0.859|TWO_SIDED|95.0|-1.389|1.655||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA|||||1.655|-1.389|0.859
70918027|NCT02079844|141327300|SUPERIORITY_OR_OTHER||LS Mean Difference|1.938|STANDARD_ERROR_OF_MEAN|1.2436||0.131|TWO_SIDED|95.0|-0.614|4.49||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA|||||4.490|-0.614|0.131
70918028|NCT02079844|141327300|SUPERIORITY_OR_OTHER||LS Mean Difference|2.377|STANDARD_ERROR_OF_MEAN|1.2545||0.069|TWO_SIDED|95.0|-0.198|4.951||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA|||||4.951|-0.198|0.069
71093169|NCT06442800|141693527|SUPERIORITY||Mean Difference (Final Values)|1.75|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Multiple cancers vs. Control||||<0.001
71093170|NCT06442800|141693527|SUPERIORITY||Mean Difference (Final Values)|1.59|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Dementia vs. Control||||<0.001
70918029|NCT02079844|141327301|SUPERIORITY_OR_OTHER||LS Mean Difference|0.076|STANDARD_ERROR_OF_MEAN|0.1757||0.671|TWO_SIDED|95.0|-0.739|0.106||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA|||||0.106|-0.739|0.671
70918030|NCT02079844|141327301|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.171|STANDARD_ERROR_OF_MEAN|0.1757||0.345|TWO_SIDED|95.0|-1.193|0.571||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA|||||0.571|-1.193|0.345
70918031|NCT01420549|141327316|NON_INFERIORITY|The non-inferiority assessment was analyzed by the bilateral confidence interval (95%) for the ratio of the mean LDLfinal/LDLbaseline of the R/E combination, compared to the mean LDLfinal/LDLbaseline of the S/E combination and the bilateral confidence interval (95%) for the difference between the two means of the percentage variation of LDL-C in the treatments (\[(LDLfinal - LDLbaseline)/LDLbaseline))\*100)R+E\] - \[(LDLfinal - LDLbaseline)/LDLbaseline))\*100)S+E\].|Median Difference (Final Values)|-10.32|STANDARD_ERROR_OF_MEAN|3.33||0.0013|TWO_SIDED|95.0|-16.94|-3.7|||ANCOVA|Estimates for treatment effect and their 95% confidence intervals were exponentiated to produce estimates of percentage change.|Mean Percentage Change LDL- C (%)|Rosuvastatin + Ezetimibe versus Simvastatin + Ezetimibe||-3.70|-16.94|0.0013
70918032|NCT01040689|141327390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.145|0.224|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.224|0.145|<0.0001
70918033|NCT01040689|141327390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.167|0.246|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.246|0.167|<0.0001
70918034|NCT01040689|141327390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.133|0.212|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.212|0.133|<0.0001
70918035|NCT01040689|141327391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.09|0.173|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.173|0.090|<0.0001
70918036|NCT01040689|141327391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.136|0.219|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.219|0.136|<0.0001
70918037|NCT01040689|141327391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.081|0.164|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.164|0.081|<0.0001
70918038|NCT01040689|141327392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.121|0.196|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.196|0.121|<0.0001
70918039|NCT01040689|141327392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.155|0.23|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.230|0.155|<0.0001
70918040|NCT01040689|141327392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.11|0.185|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.185|0.110|<0.0001
70918041|NCT01040689|141327393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.147|0.216|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.216|0.147|<0.0001
71093171|NCT06442800|141693527|SUPERIORITY||Mean Difference (Final Values)|1.54|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Colorectal cancer vs. Control||||<0.001
70918042|NCT01040689|141327393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.178|0.247|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.247|0.178|<0.0001
70918043|NCT01040689|141327393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.097|0.167|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.167|0.097|<0.0001
70918044|NCT01040689|141327394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.17|0.243|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.243|0.170|<0.0001
70918045|NCT01040689|141327394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.179|0.252|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.252|0.179|<0.0001
70918046|NCT01040689|141327394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.146|0.219|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.219|0.146|<0.0001
71093172|NCT06442800|141693527|SUPERIORITY||Mean Difference (Final Values)|1.6|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Liver cancer vs. Control||||<0.001
71093173|NCT06442800|141693527|SUPERIORITY||Mean Difference (Final Values)|1.66|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Throat and mouth cancer vs. Control||||<0.001
70918047|NCT01040689|141327395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.177|0.249|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.249|0.177|<0.0001
70918048|NCT01040689|141327395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.239|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.203|0.275|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.275|0.203|<0.0001
70918049|NCT01040689|141327395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.125|0.197|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.197|0.125|<0.0001
70918050|NCT01040689|141327396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.168|0.258|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.258|0.168|<0.0001
70918051|NCT01040689|141327396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.234|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.189|0.279|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.279|0.189|<0.0001
70918052|NCT01040689|141327396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.201|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.156|0.246|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.246|0.156|<0.0001
70918053|NCT01040689|141327397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.096|0.17|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.170|0.096|<0.0001
70918054|NCT01040689|141327397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.11|0.184|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.184|0.110|<0.0001
70918055|NCT01040689|141327397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.06|0.134|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.134|0.060|<0.0001
70918056|NCT01040689|141327398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.282|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.216|0.348|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.348|0.216|<0.0001
71093174|NCT06442800|141693527|SUPERIORITY||Mean Difference (Final Values)|1.52|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Liver disease vs. Control||||<0.001
70918057|NCT01040689|141327398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.303|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.237|0.368|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.368|0.237|<0.0001
71153943|NCT00488683|141800066|SUPERIORITY_OR_OTHER||R-square|0.08||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||
70918058|NCT01040689|141327398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.276|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.21|0.342|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.342|0.210|<0.0001
70918059|NCT01040689|141327399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.196|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.131|0.262|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.262|0.131|<0.0001
70918060|NCT01040689|141327399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.252|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.187|0.318|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.318|0.187|<0.0001
70918061|NCT01040689|141327399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.118|0.249|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.249|0.118|<0.0001
70918062|NCT01040689|141327400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.178|0.301|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.301|0.178|<0.0001
70918063|NCT01040689|141327400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.216|0.339|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.339|0.216|<0.0001
71093175|NCT06442800|141693527|SUPERIORITY||Mean Difference (Final Values)|1.45|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Hypertension vs. Control||||<0.001
71093176|NCT06442800|141693527|SUPERIORITY||Mean Difference (Final Values)|1.52|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Current warning vs. Control||||<0.001
71093177|NCT06442800|141693527|SUPERIORITY||Mean Difference (Final Values)|0.93|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Guidelines vs. Control||||<0.001
71153944|NCT00488683|141800066|SUPERIORITY_OR_OTHER||R-square|0.13||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||
70918064|NCT01040689|141327400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.168|0.291|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.291|0.168|<0.0001
70918065|NCT01040689|141327401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.268|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.207|0.33|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.330|0.207|<0.0001
70918066|NCT01040689|141327401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.312|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.251|0.374|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.374|0.251|<0.0001
70918067|NCT01040689|141327401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.153|0.277|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.277|0.153|<0.0001
70918068|NCT01040689|141327402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.317|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.246|0.388|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.388|0.246|<0.0001
70918069|NCT01040689|141327402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.318|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.247|0.388|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.388|0.247|<0.0001
70918070|NCT01040689|141327402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.302|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.231|0.373|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.373|0.231|<0.0001
70918071|NCT01040689|141327403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.222|0.378|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.378|0.222|<0.0001
70918072|NCT01040689|141327403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.297|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.22|0.375|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.375|0.220|<0.0001
70918073|NCT01040689|141327403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.295|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.217|0.373|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.373|0.217|<0.0001
70918074|NCT01040689|141327404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.115|0.255|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.255|0.115|<0.0001
70918075|NCT01040689|141327404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.212|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.143|0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.282|0.143|<0.0001
71093178|NCT06442800|141693528|SUPERIORITY||Difference in predicted proportions|0.38|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Multiple cancers vs. Control||||<0.001
70918076|NCT01040689|141327404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.036||0.0003||95.0|0.059|0.199|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.199|0.059|0.0003
70918077|NCT01185561|141327406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.89|STANDARD_ERROR_OF_MEAN|2.43||0.001|TWO_SIDED|95.0|4.03|13.76|||t-test, 2 sided|||The null hypothesis is that there is no difference in CES-D score between those assigned to the psychoeducational intervention and those assigned to usual medical care six months after randomization.||13.76|4.03|.001
70918078|NCT01185561|141327407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.82|STANDARD_ERROR_OF_MEAN|3.27||0.02|TWO_SIDED|95.0|1.29|14.37|||t-test, 2 sided|||The null hypothesis is that there is no difference in the State Anxiety Sub-test score between those assigned to the psychoeducational intervention and those assigned to usual medical care six months after randomization.||14.37|1.29|.02
70918079|NCT01185561|141327408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.48|STANDARD_ERROR_OF_MEAN|2.91||0.005|TWO_SIDED|95.0|2.64|14.31|||t-test, 2 sided|||The null hypothesis is that there is no difference in the State Trait Anxiety Sub-test score between those assigned to the psychoeducational intervention and those assigned to usual medical care six months after randomization.||14.31|2.64|.005
70918080|NCT01185561|141327409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73|STANDARD_ERROR_OF_MEAN|3.75||0.85|TWO_SIDED|95.0|-6.77|8.24|||t-test, 2 sided|||The null hypothesis is that there is no difference in the State Trait Anger Expression Sub-test score between those assigned to the psychoeducational intervention and those assigned to usual medical care six months after randomization.||8.24|-6.77|.85
70918081|NCT01599793|141327439|EQUIVALENCE|Testing if the change of ktrans between 2 weeks and baseline = 0 (i.e testing if the difference of means between 2 weeks and baseline =0)||||||0.0016|||||||Mixed Models Analysis|||The least square means of ktrans at different time points (baseline, 2 weeks, 12 weeks, 24 weeks) are estimated by a linear mixed model. Comparison of means at different time points were performed. The primary result reported below is for the difference of means between 2 weeks and baseline.||||0.0016
71093179|NCT06442800|141693528|SUPERIORITY||Difference in predicted proportions|0.34|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Dementia vs. Control||||<0.001
71093180|NCT06442800|141693528|SUPERIORITY||Difference in predicted proportions|0.4|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Colorectal cancer vs. Control||||<0.001
71093181|NCT06442800|141693528|SUPERIORITY||Difference in predicted proportions|0.14|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Liver cancer vs. Control||||<0.001
71093182|NCT06442800|141693528|SUPERIORITY||Difference in predicted proportions|0.37|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Throat and mouth cancer vs. Control||||<0.001
71093183|NCT06442800|141693528|SUPERIORITY||Difference in predicted proportions|0.11|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Liver disease vs. Control||||<0.001
71093184|NCT06442800|141693528|SUPERIORITY||Difference in predicted proportions|0.25|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Hypertension vs. Control||||<0.001
71093185|NCT06442800|141693528|SUPERIORITY||Difference in predicted proportions|0.04||||0.02|TWO_SIDED||||||Mixed Models Analysis|||Current warning vs. Control||||0.02
71093186|NCT06442800|141693528|SUPERIORITY||Difference in predicted proportions|0.14|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Guidelines vs. Control||||<0.001
71093187|NCT02452190|141693536|SUPERIORITY|A fixed-sequence multiple testing procedure was implemented to test the primary and secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.|CAE rate ratio (reslizumab vs placebo)|0.79||||0.194|TWO_SIDED|95.0|0.562|1.124||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group, randomization stratification factors, and number of prior exacerbations as model factors and the logarithm of treatment duration excluding the summed duration of exacerbations in the treatment period as an offset variable.||1.124|0.562|0.194
70918082|NCT01599793|141327441|OTHER|We calculated Spearman Correlation Coefficient between the percent change in Ktrans (from week 0 to 12) and the bone scan response change. We tested if the coefficient = 0|Spearman Correlation Coefficients|0.36853||||0.3291|TWO_SIDED||||||t-test, 2 sided|||||||0.3291
70918083|NCT01599793|141327443|OTHER|We calculated Spearman Correlation Coefficient between the percent change in Ktrans (from week 0 to 12) and the PSA change. We tested if the coefficient = 0|Spearman Correlation Coefficients|-0.41818||||0.2006|TWO_SIDED||||||t-test, 2 sided|||||||0.2006
70918084|NCT01599793|141327445|OTHER|We calculated Spearman Correlation Coefficient between the percent change in Ktrans (from week 0 to 12) and the Change in pain scale. We tested if the coefficient = 0|Spearman Correlation Coefficients|0.17669||||0.5828|TWO_SIDED||||||t-test, 2 sided|||||||0.5828
70918085|NCT02755805|141327474|SUPERIORITY_OR_OTHER||Cohen's d effect size at month 6|1.11||||0.007|TWO_SIDED|||||a priori threshold set at p\<0.05|Mixed Models Analysis|"F(3,74)=4.37~P-values were calculated using mixed model analyses and controlled for stoke severity as a covariate."|Effect size was calculated using mean change scores (baseline to month 6) and standard error of change (baseline to month 6) for each group.|All analyses were performed using the intent-to-treat principle so that comparisons were made according to the assigned intervention group regardless of study completion.||||0.007
70918086|NCT02755805|141327475|SUPERIORITY_OR_OTHER||Cohen's d effect size at month 6|0.76||||0.09|TWO_SIDED|||||a priori threshold set at p\<0.05|Mixed Models Analysis|F(2,34)=2.55|Effect size was calculated using mean change scores (baseline to month 6) and standard error of change (baseline to month 6) for each group.|All analyses were performed using the intent-to-treat principle so that comparisons were made according to the assigned intervention group regardless of study completion.||||0.09
70918087|NCT02755805|141327476|SUPERIORITY_OR_OTHER||Cohen's d effect size at month 6|1.23||||0.002|TWO_SIDED|||||a priori threshold set at p\<0.05|Mixed Models Analysis|F(2,34)=7.83|Effect size was calculated using mean change scores (baseline to month 6) and standard error of change (baseline to month 6) for each group.|All analyses were performed using the intent-to-treat principle so that comparisons were made according to assigned intervention group regardless of study completion.||||.002
70970783|NCT01157078|141447232|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52|STANDARD_ERROR_OF_MEAN|0.42||0.13|TWO_SIDED|95.0|0.88|2.61|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.61|0.88|0.130
71093188|NCT03112603|141693572|OTHER||Odds Ratio (OR)|2.99|||<|0.0001|TWO_SIDED|95.0|1.86|4.8|||Cochran-Mantel-Haenszel|||||4.80|1.86|<0.0001
71093189|NCT03112603|141693574|OTHER||Hazard Ratio (HR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.268|0.51||The p-value was derived from a 1-sided stratified log-rank test.|Log Rank||The hazard ratio was obtained from a stratified Cox model using cGvHD severity at randomization as strata.|||0.510|0.268|<0.0001
71093190|NCT03112603|141693575|OTHER||Hazard Ratio (HR)|0.361|||||TWO_SIDED|95.0|0.268|0.485|||||The hazard ratio was obtained from a stratified Cox model using cGvHD severity at randomization as strata.|||0.485|0.268|
71093191|NCT03112603|141693576|OTHER||Odds Ratio (OR)|2.17||||0.0011|TWO_SIDED|95.0|1.34|3.52||The one-sided p-value was calculated using a stratified Cochran-Mantel-Haenszel test.|Cochran-Mantel-Haenszel||The odds ratio and 95% confidence interval (CI) were calculated using a stratified Cochran-Mantel-Haenszel test.|||3.52|1.34|0.0011
71093192|NCT03112603|141693578|OTHER||Odds Ratio (OR)|2.77|||<|0.0001|TWO_SIDED|95.0|1.75|4.39||The one-sided p-value was calculated using a stratified Cochran-Mantel-Haenszel (CMH) test.|Cochran-Mantel-Haenszel||The odds ratio and 95% CI were calculated using a stratified CMH test.|||4.39|1.75|<0.0001
71093193|NCT03112603|141693580|OTHER||Hazard Ratio (HR)|0.851||||0.2396|TWO_SIDED|95.0|0.544|1.331||The p-value was derived from a 1-sided stratified log-rank test.|Log Rank||The hazard ratio was obtained from a stratified Cox model using cGvHD severity at randomization as strata.|||1.331|0.544|0.2396
71093194|NCT03806296|141693623|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.018|TWO_SIDED|95.0|-0.77|-0.07|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||-0.07|-0.77|0.018
71093195|NCT03806296|141693623|SUPERIORITY||Time X Group interaction|0.67||||0.001|TWO_SIDED|95.0|0.28|1.07|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoints, and sex.||1.07|0.28|0.001
70918088|NCT02755805|141327477|SUPERIORITY_OR_OTHER||Cohen's d effect size at month 6|0.7||||0.04|TWO_SIDED|||||a priori threshold set at \<0.05|repeated measures fixed effects model|F(2,28)=3.61|Effect size was calculated using mean change scores (baseline to month 6) and standard error of change (baseline to month 6) for each group.|All analyses were performed using the intent-to-treat principle so that comparisons were made according to the assigned intervention group regardless of study completion.||||.04
70918089|NCT02252042|141327487|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0316|TWO_SIDED|95.0|0.67|1.01|||Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||1.01|0.67|0.03160
70918090|NCT02252042|141327488|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.01605|TWO_SIDED|95.0|0.65|0.98||Nominal p-value|Log Rank||Nominal HR. Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||0.98|0.65|0.01605
70918091|NCT02252042|141327489|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.00493|TWO_SIDED|95.0|0.58|0.93|||Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||0.93|0.58|0.00493
70918092|NCT02252042|141327490|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.32504|TWO_SIDED|95.0|0.79|1.16|||Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||1.16|0.79|0.32504
70918093|NCT02252042|141327491|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.07736|TWO_SIDED|95.0|0.69|1.06|||Log Rank||Cox regression model with treatment as a single covariate|||1.06|0.69|0.07736
70918094|NCT02252042|141327492|SUPERIORITY||Difference in percentages|4.6||||0.061|TWO_SIDED|95.0|-1.2|10.6|||Log Rank|H0: difference in %=0; H1: difference in %\>0|Stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||10.6|-1.2|0.0610
70918095|NCT02252042|141327493|SUPERIORITY||Difference in percentages|7.5||||0.0171|TWO_SIDED|95.0|0.6|14.6|||Log Rank|H0: difference in %=0; H1: difference in %\>0|Stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||14.6|0.6|0.0171
70918096|NCT02252042|141327496|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.14545|TWO_SIDED|95.0|0.7|1.12||p-value stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||1.12|0.70|0.14545
70918097|NCT02252042|141327497|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.05851|TWO_SIDED|95.0|0.62|1.06||p-value stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||1.06|0.62|0.05851
70918098|NCT02252042|141327498|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.65759|TWO_SIDED|95.0|0.86|1.27|||Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||1.27|0.86|0.65759
70918099|NCT02252042|141327499|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.51982|TWO_SIDED|95.0|0.81|1.26|||Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||1.26|0.81|0.51982
70918100|NCT02658240|141327504|SUPERIORITY|||||||0.05|||||||ANOVA|||The study was powered to detect a mean difference of 1.5 in pain scores in favor of patients undergoing SFICB procedure assuming a standard deviation of 2.5. With a two sided alpha level of 0.05, a total of 52 patients would be needed to have 80% power using a repeated measures ANOVA F test with 6 observations on each subject. Correlation on the repeat observations was assumed to be 0.5. Assuming a 14% loss to follow-up, 60 patients were enrolled at 1:1 ratio.||||0.05
70918101|NCT02658240|141327505|SUPERIORITY|||||||0.05|||||||ANOVA|||||||0.05
70918102|NCT02658240|141327506|SUPERIORITY|||||||0.149|TWO_SIDED|80.0|||||t-test, 2 sided|||||||0.149
70918103|NCT02658240|141327507|SUPERIORITY|||||||0.584|TWO_SIDED|80.0|||||Wilcoxon (Mann-Whitney)|||||||0.584
70918104|NCT00475319|141327543|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||versus placebo|t-test, 2 sided|a general linear model||||||0.001
70918105|NCT00475319|141327544|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||versus placebo|t-test, 2 sided|a general linear model||||||0.001
70918106|NCT02755116|141327556|SUPERIORITY||Adjusted relative risk|0.76||||0.003|TWO_SIDED|95.0|0.48|1.2|||log-binomial regression|||||1.20|0.48|0.003
70918107|NCT02214160|141327565|SUPERIORITY|||||||0.0347|||||||Paired T-test|||||||0.0347
70918108|NCT02214160|141327566|SUPERIORITY|||||||0.0343|||||||Wilcoxon Signed Rank Test|||||||0.0343
70918109|NCT02423798|141327582|OTHER||Mean|9.13|||||TWO_SIDED|||||||||||||
70918110|NCT01063972|141327585|SUPERIORITY|||||||0.46|||||||Chi-squared|||||||0.46
70918111|NCT01063972|141327586|SUPERIORITY|||||||0.22|||||||Chi-squared|||||||0.22
70918112|NCT01063972|141327587|SUPERIORITY|||||||0.56|||||||Chi-squared|||||||0.56
70918113|NCT01063972|141327588|SUPERIORITY|||||||0.48|||||||Chi-squared|||||||0.48
70918114|NCT02476409|141327606|SUPERIORITY|||||||0.094|||||||Kruskal-Wallis|||||||0.094
70918115|NCT02476409|141327607|SUPERIORITY|||||||0.166|||||||Kruskal-Wallis|||||||0.166
70918116|NCT02476409|141327607|SUPERIORITY|||||||0.491|||||||Kruskal-Wallis|||||||0.491
70918117|NCT02476409|141327608|SUPERIORITY|||||||0.543|||||||Kruskal-Wallis|||P-value for Change in Dyspnea VAS - Baseline to Day 3 Tolvaptan versus placebo.||||0.543
70918118|NCT02476409|141327609|SUPERIORITY|||||||0.05|||||||Kruskal-Wallis|||||||0.050
70918119|NCT02476409|141327610|SUPERIORITY|||||||0.092|||||||Fisher Exact|||||||0.092
70918120|NCT02476409|141327611|SUPERIORITY|||||||0.034|||||||Kruskal-Wallis|||||||0.034
70918121|NCT02476409|141327612|SUPERIORITY|||||||0.643|||||||Kruskal-Wallis|||||||0.643
70918122|NCT00275392|141327613|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||Interaction effect|RM ANOVA|||||||0.026
70918123|NCT00275392|141327613|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||main effect of time|RM ANOVA|||||||<.001
70918124|NCT00275392|141327613|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||main effect of group|RM ANOVA|||||||>.05
70918125|NCT00275392|141327614|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Interaction effect|RM ANOVA|||||||> 0.05
70918126|NCT00275392|141327614|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED|||||main effect of time|RM ANOVA|||||||.016
70918127|NCT00275392|141327614|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Main effect of Group|RM ANOVA|||||||>.05
70918128|NCT00468052|141327615|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Null hypothesis is not significantly different from group D and F.|Wilcoxon (Mann-Whitney)|||Sixty subjects were required per group to determine that with Dex would decrease the incidence of severe EA after surgery by 50% with 80% power (0.05)in comparison with the control group.60 subjects were required by group to show the that intraoperative rescue fentanyl and rescue morphine in the PACU would be 50% lower in subjects receiving dex.||||.001
70918129|NCT00468052|141327615|NON_INFERIORITY_OR_EQUIVALENCE|Treatment with Dex would reduce the incidence of severe agitation be 50% with an 80% power (alpha 0.05)||||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Null hypothesis dexmedetomidine would be a safe and effective substitute to opiates in reducing pain and the incidence of severe EA||||.001
70918130|NCT00468052|141327616|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.004
70918131|NCT00468052|141327618|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Fisher Exact|||||||0.03
70918132|NCT00468052|141327619|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Fisher Exact|||||||0.02
70918133|NCT02928224|141327647|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
70918134|NCT02928224|141327648|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
70918135|NCT02928224|141327649|OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
70918136|NCT02928224|141327658|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
70970784|NCT01157078|141447233|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75|STANDARD_ERROR_OF_MEAN|0.96||0.307|TWO_SIDED|95.0|0.6|5.14|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||5.14|0.60|0.307
70918137|NCT02928224|141327659|OTHER|||||||0.5958|||||||Stratified Log-rank|||||||0.5958
70918138|NCT02928224|141327660|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
70918139|NCT02928224|141327661|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
70918140|NCT02928224|141327662|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
70918141|NCT02928224|141327663|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
70918142|NCT02928224|141327664|OTHER|||||||0.1004|||||||Stratified Log-rank|||||||0.1004
70918143|NCT02928224|141327665|OTHER|||||||0.3724|||||||Stratified Log-rank|||||||0.3724
70918144|NCT02928224|141327666|OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
70918145|NCT02928224|141327667|OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
70918146|NCT02928224|141327668|OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
70918147|NCT02928224|141327669|OTHER|||||||0.1928|||||||Cochran-Mantel-Haenszel|||||||0.1928
70918148|NCT02928224|141327670|OTHER|||||||0.0357|||||||Cochran-Mantel-Haenszel|||||||0.0357
70918149|NCT00468910|141327713|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The study was powered to detect an attributable change in the aspirin group of 50% relative to baseline values - an approximate 50% increase in spectral slope.||||0.11
70918150|NCT00468910|141327714|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.17
70918151|NCT01943799|141327765|SUPERIORITY||LS Mean Difference|-0.001||||0.976|TWO_SIDED|95.0|-0.061|0.059|||MMRM|||Each null hypothesis was tested against the 2-sided alternative that the mean change from baseline in serum HBsAg (log10 IU/mL) titers in the respective GS-4774 group was not equal to that of the OAV group. Estimated least squares means (LSM) of treatment effects and estimated differences in treatment effects between GS-4774 treatment groups and the OAV group at Week 24 were calculated with 95% confidence intervals (CIs) and unadjusted p-values.||0.059|-0.061|0.976
70918152|NCT01943799|141327765|SUPERIORITY||LS Mean Difference|-0.007||||0.828|TWO_SIDED|95.0|-0.067|0.053|||MMRM|||Each null hypothesis was tested against the 2-sided alternative that the mean change from baseline in serum HBsAg (log10 IU/mL) titers in the respective GS-4774 group was not equal to that of the OAV group. Estimated least squares means (LSM) of treatment effects and estimated differences in treatment effects between GS-4774 treatment groups and the OAV group at Week 24 were calculated with 95% confidence intervals (CIs) and unadjusted p-values.||0.053|-0.067|0.828
70918153|NCT01943799|141327765|SUPERIORITY||LS Mean Difference|-0.029||||0.343|TWO_SIDED|95.0|-0.089|0.031|||MMRM|||Each null hypothesis was tested against the 2-sided alternative that the mean change from baseline in serum HBsAg (log10 IU/mL) titers in the respective GS-4774 group was not equal to that of the OAV group. Estimated least squares means (LSM) of treatment effects and estimated differences in treatment effects between GS-4774 treatment groups and the OAV group at Week 24 were calculated with 95% confidence intervals (CIs) and unadjusted p-values.||0.031|-0.089|0.343
70918154|NCT03811574|141327776|SUPERIORITY||Treatment difference|-7.52|||<|0.0001|TWO_SIDED|95.0|-9.62|-5.43|||ANCOVA|||Treatment policy estimand||-5.43|-9.62|<.0001
70918155|NCT03811574|141327776|SUPERIORITY||Treatment difference|-11.06|||<|0.0001|TWO_SIDED|95.0|-12.88|-9.24|||ANCOVA|||Treatment policy estimand||-9.24|-12.88|<.0001
70918156|NCT03811574|141327777|SUPERIORITY||Odds Ratio (OR)|11.08|||<|0.0001|TWO_SIDED|95.0|5.53|22.22|||Regression, Logistic|||Treatment policy estimand||22.22|5.53|<.0001
70918157|NCT03811574|141327777|SUPERIORITY||Odds Ratio (OR)|21.72|||<|0.0001|TWO_SIDED|95.0|11.27|41.86|||Regression, Logistic|||Treatment policy estimand||41.86|11.27|<.0001
70918158|NCT00958633|141327822|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.12|TWO_SIDED|95.0|0.43|1.1|||Log Rank||The hazard ratio for time to any mood episode in the 52-week group relative to the 8-week group was 0.68 (95% confidence interval \[CI\], 0.43 to 1.10; P = 0.12 by log-rank test).|||1.10|0.43|0.12
70918159|NCT00958633|141327823|SUPERIORITY||Hazard Ratio (HR)|2.28|||||TWO_SIDED|95.0|0.86|6.08||||||Manic or Hypomanic events||6.08|.86|
70918160|NCT00958633|141327823|SUPERIORITY||Hazard Ratio (HR)|0.43|||||TWO_SIDED|95.0|0.25|0.75||||||Depressive Events||0.75|0.25|
70918161|NCT02601170|141327826|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70970785|NCT01157078|141447234|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44|STANDARD_ERROR_OF_MEAN|0.52||0.313|TWO_SIDED|95.0|0.71|2.94|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.94|0.71|0.313
70970786|NCT01157078|141447235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77|STANDARD_ERROR_OF_MEAN|0.79||0.201|TWO_SIDED|95.0|0.74|4.24|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||4.24|0.74|0.201
70918162|NCT01415349|141327840|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Point estimates and 90% confidence intervals were assessed against the currently accepted bioequivalence criteria for log-transformed data (0.80, 1.25).|Ratio of Geometric LS Means|1.03|||||TWO_SIDED|90.0|0.966|1.09|||Mixed Models Analysis|||||1.09|0.966|
70918163|NCT01415349|141327841|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Point estimates and 90% confidence intervals were assessed against the currently accepted bioequivalence criteria for log-transformed data (0.80, 1.25).|Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|0.998|1.08|||Mixed Models Analysis|||||1.08|0.998|
70918164|NCT01616459|141327842|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =1.51 in the 11Pn Group and N= 203 and Adjusted GMC= 1.36 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.9|||||TWO_SIDED|95.9|0.75|1.07||||||ANTI-1 serotype test :to demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.07|0.75|
70918165|NCT01616459|141327842|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =1.77 in the 11Pn Group and N= 203 and Adjusted GMC= 1.66 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.94|||||TWO_SIDED|95.9|0.77|1.14||||||ANTI-4 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.14|0.77|
70918166|NCT01616459|141327842|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC = 2.46 in the 11Pn Group and N= 201 and Adjusted GMC= 2.16 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.88|||||TWO_SIDED|95.9|0.75|1.03||||||ANTI-5 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.03|0.75|
70918167|NCT01616459|141327842|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =0.51 in the 11Pn Group and N= 200 and Adjusted GMC= 0.47 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.93|||||TWO_SIDED|95.9|0.71|1.23||||||ANTI-6B serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.23|0.71|
70918168|NCT01616459|141327842|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=219 and Adjusted GMC =2.30 in the 11Pn Group and N= 202 and Adjusted GMC= 2.17 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.94|||||TWO_SIDED|95.9|0.81|1.1||||||ANTI-7F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.10|0.81|
70918169|NCT01616459|141327842|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =1.56 in the 11Pn Group and N= 200 and Adjusted GMC= 1.40 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.89|||||TWO_SIDED|95.9|0.76|1.06||||||ANTI-9V serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.06|0.76|
70970787|NCT01157078|141447236|SUPERIORITY_OR_OTHER||LS mean|-0.5|STANDARD_ERROR_OF_MEAN|0.82||0.552|TWO_SIDED|95.0|-2.1|1.12|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.12|-2.10|0.552
70918170|NCT01616459|141327842|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC = 4.22 in the 11Pn Group and N= 201 and Adjusted GMC= 4.06 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.96|||||TWO_SIDED|95.9|0.81|1.15||||||ANTI-14 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.15|0.81|
70918171|NCT01616459|141327842|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =2.81 in the 11Pn Group and N= 201 and Adjusted GMC= 2.57 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.92|||||TWO_SIDED|95.9|0.74|1.14||||||ANTI-18C serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.14|0.74|
70918172|NCT01616459|141327842|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC = 3.70 in the 11Pn Group and N= 202 and Adjusted GMC= 3.68 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|1.0|||||TWO_SIDED|95.9|0.81|1.23||||||ANTI-19F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.23|0.81|
70918173|NCT01616459|141327842|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC = 0.62 in the 11Pn Group and N= 199 and Adjusted GMC= 0.71 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|1.15|||||TWO_SIDED|95.9|0.89|1.48||||||ANTI-23F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.48|0.89|
70918174|NCT01616459|141327842|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations/titres, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=217 and Adjusted GMC =1.61 in the 11Pn Group and N= 206 and Adjusted GMC= 2.75 for the Prevnar13 Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|1.71|||||TWO_SIDED|95.9|1.44|2.03||||||ANTI-19A serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||2.03|1.44|
70918175|NCT01616459|141327842|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=207 and Adj. GMC =1.58 in 12Pn Group and N= 203 and Adj. GMC= 1.35 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.86||||||95.8|0.72|1.02||||||ANTI-1 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.02|0.72|
70918176|NCT01616459|141327842|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =1.94 in 12Pn Group and N= 203 and Adj. GMC= 1.66 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.86||||||95.8|0.7|1.05||||||ANTI-4 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.05|0.70|
70918177|NCT01616459|141327842|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =2.37 in 12Pn Group and N= 201 and Adj. GMC= 2.16 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.91|||||TWO_SIDED|95.8|0.78|1.07||||||ANTI-5 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.07|0.78|
70918178|NCT01616459|141327842|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =0.56 in 12Pn Group and N= 200 and Adj. GMC= 0.47 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.84||||||95.8|0.64|1.11||||||ANTI-6B serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.11|0.64|
70918179|NCT01616459|141327842|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=211 and Adj. GMC =2.42 in 12Pn Group and N= 202 and Adj. GMC= 2.17 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.9|||||TWO_SIDED|95.8|0.76|1.06||||||ANTI-7F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.06|0.76|
70918180|NCT01616459|141327842|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =1.78 in 12Pn Group and N= 200 and Adj. GMC= 1.40 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.79|||||TWO_SIDED|95.8|0.67|0.93||||||ANTI-9V serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||0.93|0.67|
70918181|NCT01616459|141327842|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=209 and Adj. GMC =4.48 in 12Pn Group and N= 201 and Adj. GMC= 4.10 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.91|||||TWO_SIDED|95.8|0.77|1.09||||||ANTI-14 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.09|0.77|
70918182|NCT01616459|141327842|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=209 and Adj. GMC =2.55 in 12Pn Group and N= 201 and Adj. GMC= 2.57 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|1.01|||||TWO_SIDED|95.8|0.81|1.26||||||ANTI-18C serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.26|0.81|
71093196|NCT03806296|141693624|SUPERIORITY||Mean Difference (Final Values)|1.1|||<|0.001|TWO_SIDED|95.0|0.61|1.59|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||1.59|0.61|<0.001
71093197|NCT03806296|141693624|SUPERIORITY||Time X Group interaction|-0.76|||<|0.001|TWO_SIDED|95.0|-1.09|-0.43|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoints, and sex.||-0.43|-1.09|<0.001
71153945|NCT00488683|141800066|SUPERIORITY_OR_OTHER||R-square|0.28||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||
70918183|NCT01616459|141327842|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=211 and Adj. GMC =3.29 in 12Pn Group and N= 202 and Adj. GMC= 3.67 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|1.12|||||TWO_SIDED|95.8|0.9|1.38||||||ANTI-19F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.38|0.90|
70918184|NCT01616459|141327842|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =0.68 in 12Pn Group and N= 199 and Adj. GMC= 0.71 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI..|Adjusted GMCs ratio|1.05|||||TWO_SIDED|95.8|0.81|1.37||||||ANTI-23F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.37|0.81|
70918185|NCT01616459|141327842|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=210 and Adj. GMC =1.09 in 12Pn Group and N= 214 and Adj. GMC= 2.07 for Prevnar13 Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|1.9|||||TWO_SIDED|95.8|1.51|2.39||||||ANTI-6A serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A\&19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||2.39|1.51|
70918186|NCT01616459|141327842|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =1.19 in 12Pn Group and N= 206 and Adj. GMC= 2.76 for Prevnar13 Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|2.32|||||TWO_SIDED|95.8|1.94|2.77||||||ANTI-19A serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A\&19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||2.77|1.94|
70918187|NCT01616459|141327843|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.98|||||TWO_SIDED|95.9|-3.89|1.36||||||ANTI-1 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||1.36|-3.89|
70918188|NCT01616459|141327843|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9% Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-1.08|||||TWO_SIDED|95.9|-4.94|2.45||||||ANTI-4 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||2.45|-4.94|
70918189|NCT01616459|141327843|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.48|||||TWO_SIDED|95.9|-2.82|1.38||||||ANTI-5 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||1.38|-2.82|
71153946|NCT00488683|141800066|SUPERIORITY_OR_OTHER||R-square|0.3||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup A||||
70970788|NCT01157078|141447237|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.803||95.0|-0.31|0.24|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.24|-0.31|0.803
70918190|NCT01616459|141327843|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-2.24|||||TWO_SIDED|95.9|-10.65|6.13||||||ANTI-6B serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||6.13|-10.65|
70918191|NCT01616459|141327843|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.03|||||TWO_SIDED|95.9|-2.39|2.21||||||ANTI-7F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||2.21|-2.39|
70918192|NCT01616459|141327843|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|0.4|||||TWO_SIDED|95.9|-2.36|3.22||||||ANTI-9V serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||3.22|-2.36|
70918193|NCT01616459|141327843|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|0.45|||||TWO_SIDED|95.9|-1.51|2.66||||||ANTI-14 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||2.66|-1.51|
70918194|NCT01616459|141327843|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-1.0|||||TWO_SIDED|95.9|-4.18|1.7||||||ANTI-18C serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||1.70|-4.18|
70918195|NCT01616459|141327843|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-2.38|||||TWO_SIDED|95.9|-5.64|-0.52||||||ANTI-19F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||-0.52|-5.64|
70970789|NCT01157078|141447238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|STANDARD_ERROR_OF_MEAN|0.28||0.44|TWO_SIDED|95.0|0.75|1.91|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||1.91|0.75|0.440
70970790|NCT01157078|141447239|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.55||0.768|TWO_SIDED|95.0|-0.91|1.23||Analysis for change in MADRS total score from randomization to Week 9.|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.23|-0.91|0.768
70918196|NCT01616459|141327843|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|2.73|||||TWO_SIDED|95.9|-4.84|10.25||||||ANTI-23F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||10.25|-4.84|
70918197|NCT01616459|141327844|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|0.89|||||TWO_SIDED|95.9|-1.46|3.66||||||ANTI-19A serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||3.66|-1.46|
70918198|NCT01616459|141327845|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.49|||||TWO_SIDED|95.8|-3.44|2.22||||||ANTI-1 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||2.22|-3.44|
70918199|NCT01616459|141327845|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.06|||||TWO_SIDED|95.8|-4.03|3.86||||||ANTI-4 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||3.86|-4.03|
70918200|NCT01616459|141327845|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.01|||||TWO_SIDED|95.8|-2.37|2.3||||||ANTI-5 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||2.30|-2.37|
70918201|NCT01616459|141327845|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-4.67|||||TWO_SIDED|95.8|-12.94|3.6||||||ANTI-6B serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||3.60|-12.94|
70918202|NCT01616459|141327845|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|0.46|||||TWO_SIDED|95.8|-1.93|3.06||||||ANTI-7F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||3.06|-1.93|
70918203|NCT01616459|141327845|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.02|||||TWO_SIDED|95.8|-2.72|2.64||||||ANTI-9V serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||2.64|-2.72|
70918204|NCT01616459|141327845|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|0.0|||||TWO_SIDED|95.8|-1.94|1.9||||||ANTI-14 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||1.90|-1.94|
70918205|NCT01616459|141327845|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.5|||||TWO_SIDED|95.8|-3.72|2.52||||||ANTI-18C serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||2.52|-3.72|
70918206|NCT01616459|141327845|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.98|||||TWO_SIDED|95.8|-4.38|2.1||||||ANTI-19F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||2.10|-4.38|
70918207|NCT01616459|141327845|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|2.5|||||TWO_SIDED|95.8|-5.07|10.06||||||ANTI-23F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||10.06|-5.07|
70918208|NCT01616459|141327846|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|11.22|||||TWO_SIDED|95.8|7.22|16.49||||||ANTI-6A serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \<10% for at least 10 out of 12 vaccine pneumococcal serotypes.||16.49|7.22|
71031795|NCT02728102|141572287|SUPERIORITY|||||||0.1599||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||A pairwise analysis of proportion of participants achieving CR among the subset of participants who are not in CR at the time of randomization between the vaccine arm and lenalidomide/GM-CSF arm is conducted at 1 year post transplant.||||0.1599
71031796|NCT02728102|141572287|SUPERIORITY|||||||0.8984||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||A pairwise analysis of proportion of participants achieving CR among the subset of participants who are not in CR at the time of randomization between the vaccine arm and lenalidomide alone arm is conducted at 1 year post transplant.||||0.8984
70918209|NCT01616459|141327846|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|3.75|||||TWO_SIDED|95.8|1.03|7.57||||||ANTI-19A serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \<10% for at least 10 out of 12 vaccine pneumococcal serotypes.||7.57|1.03|
70918210|NCT00304031|141327874|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.03||||0.63|TWO_SIDED|95.0|0.88|1.2||One-sided|Log Rank||Reference level = Conventional adjuvant TMZ|This study was looking for a 20% reduction in hazard rate: null hypothesis (conventional arm): Median survival time (MST) = 14.0 mo.; alternative hypothesis (dose-dense arm): MST= 17.5 mo. A one-sided log-rank test at a significance level of 0.025 would have 80% power to detect this difference with a sample size of 750 patients (647 deaths were required for the final analysis).||1.20|0.88|0.63
70918211|NCT00304031|141327875|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.06|TWO_SIDED|95.0|0.75|1.0||Two-side significance level = 0.05|Log Rank||Reference level = Conventional adjuvant TMZ|||1.00|0.75|0.06
70918212|NCT00304031|141327876|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.44|TWO_SIDED|95.0|0.82|1.19||One-sided significance level = 0.05|Log Rank||Reference level = Conventional adjuvant TMZ|Unmethylated MGMT||1.19|0.82|0.44
70918213|NCT00304031|141327876|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.86|TWO_SIDED|95.0|0.87|1.62||One-sided significance level = 0.05|Log Rank||Reference level = Conventional adjuvant TMZ|Methylated MGMT||1.62|0.87|0.86
70918214|NCT00304031|141327877|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.15|TWO_SIDED|95.0|0.73|1.05||One-sided significance level = 0.05|Log Rank||Reference level = Conventional adjuvant TMZ|Unmethylated MGMT||1.05|0.73|0.15
70918215|NCT00304031|141327877|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.33|TWO_SIDED|95.0|0.66|1.15||One-sided significance level = 0.05|Log Rank||Reference level = Conventional adjuvant TMZ|Methylated MGMT||1.15|0.66|0.33
70918216|NCT00304031|141327878|SUPERIORITY|||||||0.012||||||Two-sided significance level of 0.05|Chi-squared|||||||0.012
70918217|NCT00304031|141327879|SUPERIORITY||||||<|0.001|||||||Chi-squared|Two-sided significance level of 0.05||||||<0.001
70918218|NCT00304031|141327880|SUPERIORITY||||||<|0.001||||||Two-sided test|Log Rank|||||||<0.001
70918219|NCT00304031|141327881|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.96
70918220|NCT00304031|141327882|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||||||0.73
70918221|NCT00304031|141327883|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||||||0.57
70918222|NCT00304031|141327884|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||||||0.78
70918223|NCT00304031|141327885|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
70918224|NCT00304031|141327886|SUPERIORITY|||||||0.74|||||||t-test, 2 sided|||||||0.74
70918225|NCT00304031|141327887|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.79
70918226|NCT00304031|141327888|SUPERIORITY|||||||0.2184|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with EORTC QLQ-C30 Global Health Status Score (baseline, 10,12, 22, 24, and 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. Treatment arm is reported here.||||0.2184
70918227|NCT00304031|141327888|SUPERIORITY|||||||0.0763|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with EORTC QLQ-C30 Global Health Status Score (baseline, 10,12, 22, 24, and 46 weeks) as the outcome of interest. Treatment arm, RPA class, MGMT status, and time were included in the model. RPA class is reported here.||||0.0763
70918228|NCT00304031|141327888|SUPERIORITY|||||||0.5235|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with EORTC QLQ-C30 Global Health Status Score (baseline, 10,12, 22, 24, and 46 weeks) as the outcome of interest. Treatment arm, RPA class, MGMT status, and time were included in the model. MGMT status is reported here.||||0.5235
70918229|NCT00304031|141327889|SUPERIORITY|||||||0.03|||||||Z-test of two proportions|||||||0.03
70918230|NCT00304031|141327890|SUPERIORITY|||||||0.03|||||||Z-test of two proportions|||||||0.03
70918231|NCT00304031|141327891|SUPERIORITY|||||||0.0002|||||||Chi-squared|Two-sided test||||||0.0002
70918232|NCT00304031|141327892|SUPERIORITY|||||||0.005|||||||Fisher Exact|Two-sided test||||||0.005
70918233|NCT00304031|141327893|SUPERIORITY|||||||0.018|||||||Fisher Exact|Two-sided test||||||0.018
70918234|NCT00304031|141327894|SUPERIORITY|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||||||0.1702|||||||Mixed Models Analysis|||A mixed effects model was run with MDASI Symptom Severity Score (baseline, 10, 12, 22, 24, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. Treatment arm is reported here.||||0.1702
70918235|NCT00304031|141327894|SUPERIORITY|||||||0.8159|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with EORTC QLQ-C30 Global Health Status Score (baseline, 10, 12, 22, 24, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. RPA is reported here.||||0.8159
70918236|NCT00304031|141327894|SUPERIORITY|||||||0.2174|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with EORTC QLQ-C30 Global Health Status Score (baseline, 10, 12, 22, 24, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. MGMT status is reported here.||||0.2174
70970791|NCT01157078|141447240|SUPERIORITY_OR_OTHER||LS mean|0.7|STANDARD_ERROR_OF_MEAN|0.78||0.373|TWO_SIDED|95.0|-0.84|2.24|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.24|-0.84|0.373
71093198|NCT03806296|141693625|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.365|TWO_SIDED|95.0|-0.64|0.24|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||0.24|-0.64|0.365
71093199|NCT03806296|141693625|SUPERIORITY||Time X Group interaction|-0.43||||0.067|TWO_SIDED|95.0|-0.88|0.03|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoints, and sex.||0.03|-0.88|0.067
70918237|NCT00304031|141327895|OTHER|||||||0.023|||||||Regression, Cox|||A Cox proportional hazards model was run with overall survival as the outcome of interest and baseline scores as continuous covariates. The final model was determined from stepwise selection. EORTC physical functioning, EORTC role functioning, standardized HVLT-R recognition, standardized HVLT-R recall, and standardized COWA were included in the initial model. EORTC physical functioning is reported here.||||0.023
70918238|NCT00304031|141327895|OTHER|||||||0.043|||||||Regression, Cox|||A Cox proportional hazards model was run with overall survival as the outcome of interest and baseline scores as continuous covariates. The final model was determined from stepwise selection. EORTC physical functioning, EORTC role functioning, standardized HVLT-R recognition, standardized HVLT-R recall, and standardized COWA were included in the initial model. Standardized HVLT-R recognition is reported here.||||0.043
70918239|NCT00304031|141327895|OTHER|||||||0.021|||||||Regression, Cox|||A Cox proportional hazards model was run with overall survival as the outcome of interest and baseline scores as continuous covariates. The final model was determined from stepwise selection. EORTC physical functioning, EORTC role functioning, standardized HVLT-R recognition, standardized HVLT-R recall, and standardized COWA were included in the initial model. Standardized COWA is reported here.||||0.021
70918240|NCT00304031|141327896|SUPERIORITY|||||||0.2357|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with NCF Composite Score (baseline, 10, 22, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. Treatment arm is reported here.||||0.2357
70918241|NCT00304031|141327896|SUPERIORITY|||||||0.0147|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with NCF Composite Score (baseline, 10, 22, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. RPA is reported here.||||0.0147
70918242|NCT00304031|141327896|SUPERIORITY|||||||0.457|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with NCF Composite Score (baseline, 10, 22, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. MGMT Status is reported here.||||0.457
70918243|NCT00304031|141327897|SUPERIORITY|||||||0.02|||||||Chi-squared|Two-sided test||||||0.02
70918244|NCT00304031|141327898|SUPERIORITY|||||||0.99|||||||Fisher Exact|Two-sided test||||||0.99
70918245|NCT00304031|141327899|SUPERIORITY|||||||0.33|||||||Fisher Exact|Two-sided test||||||0.33
70918246|NCT02189252|141327923|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|160.05||||0.2702|TWO_SIDED|95.0|64.71|395.82||The closed sequential testing procedure stopped at this step as the P Value is greater than 0.05.|Mixed Models Analysis|||In order to address the issue of multiple testing while maintaining overall type I error, a closed testing sequence was used involving 4 analyses stated in the primary objective of this study. In total, 4 statistical tests, each at a significance level of 5%, were carried along the fixed sequence until the first statistically non-significant treatment difference was observed (i.e. p-value\>0.05). This is the first test in the fixed testing sequence.||395.82|64.71|0.2702
70918247|NCT02189252|141327923|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|121.61||||0.6367|TWO_SIDED|95.0|49.17|300.76||The p-value was only interpreted descriptively|Mixed Models Analysis|||In order to address the issue of multiple testing while maintaining overall type I error, a closed testing sequence was used involving 4 analyses stated in the primary objective of this study. In total, 4 statistical tests, each at a significance level of 5%, were carried along the fixed sequence until the first statistically non-significant treatment difference was observed (i.e. p-value\>0.05). This is the second test in the fixed testing sequence.||300.76|49.17|0.6367
70918248|NCT02189252|141327924|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|193.91||||0.0511|TWO_SIDED|95.0|99.61|377.47||The p-value was only interpreted descriptively|Mixed Models Analysis|||In order to address the issue of multiple testing while maintaining overall type I error, a closed testing sequence was used involving 4 analyses stated in the primary objective of this study. In total, 4 statistical tests, each at a significance level of 5%, were carried along the fixed sequence until the first statistically non-significant treatment difference was observed (i.e. p-value\>0.05). This is the third test in the fixed testing sequence.||377.47|99.61|0.0511
70918249|NCT02189252|141327924|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|133.32||||0.3543|TWO_SIDED|95.0|68.49|259.52||The p-value was only interpreted descriptively|Mixed Models Analysis|||In order to address the issue of multiple testing while maintaining overall type I error, a closed testing sequence was used involving 4 analyses stated in the primary objective of this study. In total, 4 statistical tests, each at a significance level of 5%, were carried along the fixed sequence until the first statistically non-significant treatment difference was observed (i.e. p-value\>0.05). This is the fourth test in the fixed testing sequence.||259.52|68.49|0.3543
70918250|NCT02189252|141327925|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|259.19||||0.021|TWO_SIDED|95.0|119.75|560.99|||Mixed Models Analysis|||||560.99|119.75|0.0210
70918251|NCT02189252|141327925|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|177.95||||0.1256|TWO_SIDED|95.0|82.22|385.16|||Mixed Models Analysis|||||385.16|82.22|0.1256
70918252|NCT02189252|141327926|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|298.91||||0.0025|TWO_SIDED|95.0|164.32|543.74||The p-value was only interpreted descriptively|Mixed Models Analysis|||||543.74|164.32|0.0025
70918253|NCT02189252|141327926|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|187.28||||0.0418|TWO_SIDED|95.0|102.95|340.66||The p-value was only interpreted descriptively|Mixed Models Analysis|||||340.66|102.95|0.0418
70918254|NCT02189252|141327927|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|79.36||||0.6833|TWO_SIDED|95.0|22.95|274.45|||Mixed Models Analysis|||||274.45|22.95|0.6833
70918255|NCT02189252|141327927|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|69.39||||0.522|TWO_SIDED|95.0|20.07|239.98|||Mixed Models Analysis|||||239.98|20.07|0.5220
70918256|NCT02189252|141327928|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|104.78||||0.9034|TWO_SIDED|95.0|44.92|244.41|||Mixed Models Analysis|||||244.41|44.92|0.9034
70918257|NCT02189252|141327928|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|80.58||||0.5782||95.0|34.55|187.95|||Mixed Models Analysis|||||187.95|34.55|0.5782
70918258|NCT02189252|141327929|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|753.75||||0.0391|TWO_SIDED|95.0|112.03|5071.6|||Mixed Models Analysis|||||5071.6|112.03|0.0391
70918259|NCT02189252|141327929|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|104.98||||0.9578|TWO_SIDED|95.0|15.6|706.33|||Mixed Models Analysis|||||706.33|15.60|0.9578
70918260|NCT02189252|141327930|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|376.64||||0.0186|TWO_SIDED|95.0|128.55|1103.5|||Mixed Models Analysis|||||1103.5|128.55|0.0186
70918261|NCT02189252|141327930|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|131.74||||0.5955|TWO_SIDED|95.0|44.97|386.0|||Mixed Models Analysis|||||386.00|44.97|0.5955
70918262|NCT01391832|141327936|SUPERIORITY|Comparison of differences between rTMS+CPT and sham+CPT groups in change Clinical Administered Post-Traumatic Scale Total Severity Scores from baseline to 1-month follow-up.|t-value on group differences in change|-1.51|||>|0.05|ONE_SIDED|||||Predicted effects on symptom reduction were evaluated with α = 0.05 for one-tailed t-distributions, recommended for designs examining efficacy of therapeutic interventions (Overall, 1991).|Mixed Models Analysis|Restricted maximum likelihood estimators of variance components for fixed effects; Satterthwaite estimates of effective degrees of freedom.|degrees of freedom = 327|Restricted maximum likelihood estimators (ReML) of the variance components were used to compute the maximum likelihood estimators of the fixed effects parameters (i.e., group, time, therapist, all two-way interaction terms, and the three-way interaction term). Thus, we did not exclude participants with missing time points.||||>0.05
70918263|NCT01391832|141327936|SUPERIORITY|Comparison of differences between rTMS+CPT and sham+CPT groups in change Clinical Administered Post-Traumatic Scale Total Severity Scores from baseline to 3-month follow-up.|t-value on group differences in change|-2.05|||<|0.05|ONE_SIDED|||||Predicted effects on symptom reduction were evaluated with α = 0.05 for one-tailed t-distributions, recommended for designs examining efficacy of therapeutic interventions (Overall, 1991).|Mixed Models Analysis|Restricted maximum likelihood estimators of variance components for fixed effects; Satterthwaite estimates of effective degrees of freedom.|degrees of freedom = 327|Restricted maximum likelihood estimators (ReML) of the variance components were used to compute the maximum likelihood estimators of the fixed effects parameters (i.e., group, time, therapist, all two-way interaction terms, and the three-way interaction term). Thus, we did not exclude participants with missing time points.||||<0.05
70918264|NCT01391832|141327936|SUPERIORITY|Comparison of differences between rTMS+CPT and sham+CPT groups in change Clinical Administered Post-Traumatic Scale Total Severity Scores from baseline to 6-month follow-up.|t-value on group differences in change|-2.01|||<|0.05|ONE_SIDED|||||Predicted effects on symptom reduction were evaluated with α = 0.05 for one-tailed t-distributions, recommended for designs examining efficacy of therapeutic interventions (Overall, 1991).|Mixed Models Analysis|Restricted maximum likelihood estimators of variance components for fixed effects; Satterthwaite estimates of effective degrees of freedom.|degrees of freedom = 327|Restricted maximum likelihood estimators (ReML) of the variance components were used to compute the maximum likelihood estimators of the fixed effects parameters (i.e., group, time, therapist, all two-way interaction terms, and the three-way interaction term). Thus, we did not exclude participants with missing time points.||||<0.05
71093200|NCT03806296|141693626|SUPERIORITY||Mean Difference (Final Values)|3.32||||0.234|TWO_SIDED|95.0|-2.18|8.82|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||8.82|-2.18|0.234
70918265|NCT01391832|141327937|SUPERIORITY||Mean Difference (Final Values)|-0.666|STANDARD_DEVIATION|0.7101||0.3422|TWO_SIDED|1.422|-0.7548|2.088||It is not adjusted for multiple comparisons.|t-test, 2 sided|degrees of freedom = 58|mean change from baseline to 6-month follow-up, rTMS Active - rTMS Sham|Null hypothesis test of differences in N2 micro-volt change from baseline to 6-month followup.||2.088|-0.7548|.3422
70918266|NCT01391832|141327937|OTHER|The analysis examined correlations in change in N2 and PTSD symptoms.|Slope|-0.3||||0.02|TWO_SIDED|||||Not adjusted|Regression, Linear|||The analysis examined the association between change in PTSD symptoms from baseline to 6-month follow-up and the change in N2 amplitude to the threatening stimulus from baseline to 6-month follow-up.|Correlations for the individual groups were active rTMS r(28)=-.373 and sham rTMS r(32)=-.296.|||0.02
70970792|NCT01157078|141447241|SUPERIORITY_OR_OTHER||LS mean|-0.7|STANDARD_ERROR_OF_MEAN|0.9||0.435|TWO_SIDED|95.0|-2.47|1.07|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.07|-2.47|0.435
70918267|NCT01154985|141327938|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Cochran-Armitage trend test|||Proportion of responders in the EPA-E 1800 mg and 2700 mg groups compared to the proportion of responders in the placebo group compared using the Cochran-Armitage trend test in the Efficacy Evaluable analysis set. P-value less than 5% 1-sided. A total sample size of 210 (70 per arm) was planned to give 80% power for detecting a positive dose-response slope among the 3 treatment arms at 12 months.||||0.57
70918268|NCT01154985|141327939|SUPERIORITY_OR_OTHER|||||||0.0137|TWO_SIDED|||||Two-sided p-values testing for significance was performed within treatment group change from baseline and comparisons between treatment groups. Multiple comparison techniques were not applied.|ANCOVA|||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 1,800 mg/day EPA-E treatment group compared to placebo.||||0.0137
70918269|NCT01154985|141327939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.2|||||TWO_SIDED|95.0|3.4|29.1||||||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 1,800 mg/day EPA-E treatment group compared to placebo.||29.1|3.4|
70918270|NCT01154985|141327939|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||Two-sided p-values testing for significance was performed within treatment group change from baseline and comparisons between treatment groups. Multiple comparison techniques were not applied.|ANCOVA|||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 2,700 mg/day EPA-E treatment group compared to placebo.||||0.0006
70918271|NCT01154985|141327939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.0|||||TWO_SIDED|95.0|9.6|34.4||||||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 2,700 mg/day EPA-E treatment group compared to placebo.||34.4|9.6|
70918272|NCT01154985|141327940|SUPERIORITY_OR_OTHER|||||||0.1592|TWO_SIDED|||||Two-sided p-values testing for significance was performed within treatment group change from baseline and comparisons between treatment groups. Multiple comparison techniques were not applied.|ANCOVA|||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 1,800 mg/day EPA-E treatment group compared to placebo.||||0.1592
70918273|NCT01154985|141327940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.6|||||TWO_SIDED|95.0|-3.8|23.0||||||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 1,800 mg/day EPA-E treatment group compared to placebo.||23.0|-3.8|
70918274|NCT01154985|141327940|SUPERIORITY_OR_OTHER|||||||0.0153|TWO_SIDED|||||Two-sided p-values testing for significance was performed within treatment group change from baseline and comparisons between treatment groups. Multiple comparison techniques were not applied.|ANCOVA|||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 2,700 mg/day EPA-E treatment group compared to placebo.||||0.0153
70918275|NCT01154985|141327940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.0|||||TWO_SIDED|95.0|3.1|28.9||||||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 2,700 mg/day EPA-E treatment group compared to placebo.||28.9|3.1|
70918276|NCT00722046|141327974|SUPERIORITY||Least Squares (LS) Mean Difference|1.38|STANDARD_ERROR_OF_MEAN|3.04||0.6504|TWO_SIDED|90.0|-3.68|6.45|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||6.45|-3.68|0.6504
70918277|NCT00722046|141327974|SUPERIORITY||LS Mean Difference|2.02|STANDARD_ERROR_OF_MEAN|3.13||0.5213|TWO_SIDED|90.0|-3.2|7.23|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||7.23|-3.20|0.5213
70918278|NCT00722046|141327974|SUPERIORITY||LS Mean Difference|2.27|STANDARD_ERROR_OF_MEAN|3.13||0.4698|TWO_SIDED|90.0|-2.94|7.48|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||7.48|-2.94|0.4698
70918279|NCT00722046|141327974|SUPERIORITY||LS Mean Difference|1.73|STANDARD_ERROR_OF_MEAN|2.66||0.5183|TWO_SIDED|90.0|-2.71|6.17|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||6.17|-2.71|0.5183
70918280|NCT00722046|141327974|SUPERIORITY||LS Mean Difference|0.85|STANDARD_ERROR_OF_MEAN|2.7||0.7529|TWO_SIDED|90.0|-3.65|5.35|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||5.35|-3.65|0.7529
70918281|NCT00722046|141327976|SUPERIORITY||LS Mean Difference|-4.07|STANDARD_ERROR_OF_MEAN|5.59||0.4688|TWO_SIDED|90.0|-13.38|5.24|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||5.24|-13.38|0.4688
70918282|NCT00722046|141327976|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|5.64||0.9743|TWO_SIDED|90.0|-9.59|9.22|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||9.22|-9.59|0.9743
70918283|NCT00722046|141327976|SUPERIORITY||LS Mean Difference|0.84|STANDARD_ERROR_OF_MEAN|5.65||0.8824|TWO_SIDED|90.0|-8.57|10.25|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||10.25|-8.57|0.8824
71093201|NCT03806296|141693626|SUPERIORITY||Time X Group interaction|-6.15||||0.018|TWO_SIDED|95.0|-11.25|-1.06|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoint, and sex.||-1.06|-11.25|0.018
70918284|NCT00722046|141327976|SUPERIORITY||LS Mean Difference|-4.09|STANDARD_ERROR_OF_MEAN|5.81||0.4831|TWO_SIDED|90.0|-13.77|5.58|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||5.58|-13.77|0.4831
70918285|NCT00722046|141327976|SUPERIORITY||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|5.88||0.9562|TWO_SIDED|90.0|-9.48|10.13|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||10.13|-9.48|0.9562
70918286|NCT02164240|141327987|OTHER||Clinical Benefit Rate|0.0|||||TWO_SIDED|95.0|0.0|24.7||descriptive statistics only||||Clinical benefit rate of at least 30% at 16 weeks for the entire, combined population, was considered worthy of further study.||24.7|0|
70918287|NCT02731755|141327995|SUPERIORITY|||||||0.5|||||||Mixed Models Analysis|||Between time points and treatments, calculated p value||||0.5
70918288|NCT02731755|141327996|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||Ach-iAUC||||0.04
70918289|NCT02731755|141327996|SUPERIORITY|||||||0.007|||||||Mixed Models Analysis|||SNP-IAUC||||0.007
70918290|NCT02731755|141327996|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||Ach - AUC||||0.02
70918291|NCT02731755|141327997|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|||||||0.9
70918292|NCT02731755|141327999|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|||||||0.7
71093202|NCT03806296|141693627|SUPERIORITY||Mean Difference (Final Values)|0.51||||0.024|TWO_SIDED|95.0|0.07|0.94|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||0.94|0.07|0.024
70918293|NCT00414544|141328007|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority was tested.|Mean Difference (Final Values)|-0.13|STANDARD_DEVIATION|0.6|||TWO_SIDED|90.0|-2.0|1.0|||Confidence interval|The 90% lower confidence bound of the difference between CosmetaLife and Restylane were computed.|The confidence interval is built around the mean difference of the two reporting groups.|The a priori hypothesis for statistical analysis was based on predetermined clinical relevance being set to a difference score between CosmetaLife and Control (Restylane) of -0.5. This clinical relevance was set to -0.5 because the observation scale used is not accurate below 0.5 differences. That is CosmetaLife needed to be greater than 0.5 less than Control (Restylane) in the treatment difference scores to be considered inferior.||1.0|-2.0|
70918294|NCT00373386|141328010|SUPERIORITY_OR_OTHER|||||||0.644|||||||t-test, 2 sided|||compared with baseline||||0.644
70918295|NCT00373386|141328011|SUPERIORITY_OR_OTHER|||||||0.018||||||Versus baseline|t-test, 2 sided|paired||Compared with baseline||||0.018
70918296|NCT00373386|141328012|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||Comparison to baseline||||0.04
70918297|NCT00373386|141328013|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||Comparison with baseline||||0.004
70918298|NCT00373386|141328014|SUPERIORITY_OR_OTHER|||||||0.804|||||||t-test, 2 sided|||Comparison with baseline||||0.804
70918299|NCT00373386|141328015|SUPERIORITY_OR_OTHER|||||||0.095|||||||t-test, 2 sided|||Comparison with baseline||||0.095
70918300|NCT00373386|141328016|SUPERIORITY_OR_OTHER|||||||0.648|||||||t-test, 2 sided|||Comparison with baseline||||0.648
70918301|NCT01925469|141328048|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|Differences in the median change in pain scores were assessed using Wilcoxon rank sum test.||An a priori sample size calculation determined at least 28 patients were needed to detect a clinically significant 13 mm difference in pain score (α=0.05, power =0.80) with a standard deviation of 12 mm. Intention to treat analysis was performed.||||0.43
70918302|NCT01925469|141328049|SUPERIORITY_OR_OTHER|||||||0.4|||||||Fisher Exact|||Fisher exact test was used to assess differences in satisfaction scores by treatment group. Correlation between pain and satisfaction scores was assessed by Spearman's correlation coefficient.||||0.4
70918303|NCT01925469|141328050|SUPERIORITY_OR_OTHER|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
70918304|NCT00773370|141328051|SUPERIORITY_OR_OTHER||difference between slopes|8.43|STANDARD_DEVIATION|7.17|<|0.25|TWO_SIDED|||||Random effects ANOVA with random intercept and random slope compared the time course (slopes) of change in our outcome measures across three time points: baseline, three, and six-months in our two experimental groups--APA-stroke and Sittercise.|ANOVA|||||||<0.25
70918305|NCT00773370|141328051|SUPERIORITY_OR_OTHER||Slope|14.95|STANDARD_DEVIATION|4.92|<|0.004|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time||||<0.004
70918306|NCT00773370|141328051|SUPERIORITY_OR_OTHER||Slope|6.52|STANDARD_DEVIATION|5.13||0.218|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time||||.218
70918307|NCT00773370|141328052|SUPERIORITY_OR_OTHER||Difference between slopes|0.186|STANDARD_DEVIATION|0.256||0.47|TWO_SIDED|||||Random effects ANOVA with random intercept and random slope compared the time course (slopes) of change in our outcome measures across three time points: baseline, three, and six-months in our two experimental groups--APA-stroke and Sittercise.|ANOVA|||||||.47
70918308|NCT00773370|141328052|SUPERIORITY_OR_OTHER||Slope|0.215|STANDARD_DEVIATION|0.175||0.225|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time||||.225
70918309|NCT00773370|141328052|SUPERIORITY_OR_OTHER||Slope|0.029|STANDARD_DEVIATION|0.187||0.88|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time||||.88
70918310|NCT00773370|141328053|SUPERIORITY_OR_OTHER||Difference between slopes|0.002|STANDARD_DEVIATION|0.078||0.98|TWO_SIDED|||||Random effects ANOVA with random intercept and random slope compared the time course (slopes) of change in our outcome measures across three time points: baseline, three, and six-months in our two experimental groups--APA-stroke and Sittercise.|ANOVA|||||||.98
70918311|NCT00773370|141328053|SUPERIORITY_OR_OTHER||Slope|0.033|STANDARD_DEVIATION|0.054||0.54|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time||||.54
70918312|NCT00773370|141328053|SUPERIORITY_OR_OTHER||Slope|0.031|STANDARD_DEVIATION|0.057||0.59|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time||||.59
70918313|NCT00773370|141328054|SUPERIORITY_OR_OTHER||Slope|0.296|STANDARD_DEVIATION|9.77||0.98|TWO_SIDED||||||ANOVA|||Random effects ANOVA with random intercept and random slope was used to compare the time course of change in our outcome measures across three time points: baseline, three, and six-months in our two experimental groups--APA-stroke and Sittercise.||||.98
70918314|NCT00773370|141328054|SUPERIORITY_OR_OTHER||Slope|15.49|STANDARD_DEVIATION|6.19||0.02|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||||||.02
70918315|NCT00773370|141328054|SUPERIORITY_OR_OTHER||Slope|15.193|STANDARD_DEVIATION|7.553||0.051|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||||||.051
70918316|NCT01308567|141328057|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.975||||0.7574|TWO_SIDED|95.0|0.819|1.16||P-value from two-sided stratified log-rank test, stratified for ECOG PS score at baseline, measurable disease at baseline and region with commercial availability of cabazitaxel at time of randomization. Threshold for statistical significance = 0.0479|Log Rank||Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by Eastern Cooperative Oncology Group performance status (ECOG PS) score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.16|0.819|0.7574
71093203|NCT03806296|141693627|SUPERIORITY||Time X Group interaction|-0.1||||0.66|TWO_SIDED|95.0|-0.55|0.35|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoint, and sex.||0.35|-0.55|0.660
70918317|NCT01308567|141328057|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.009||||0.9967|TWO_SIDED|95.0|0.85|1.197||P-value from two-sided stratified log-rank test, stratified for ECOG PS score at baseline, measurable disease at baseline and region with commercial availability of cabazitaxel at time of randomization. Threshold for statistical significance = 0.0479|Log Rank||Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.197|0.85|0.9967
70918318|NCT01308567|141328058|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.989|||||TWO_SIDED|95.0|0.849|1.152|||||Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.152|0.849|
70918319|NCT01308567|141328058|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.063|||||TWO_SIDED|95.0|0.913|1.236|||||Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.236|0.913|
70918320|NCT01308567|141328059|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.958|||||TWO_SIDED|95.0|0.785|1.17|||||Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.17|0.785|
70918321|NCT01308567|141328059|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.916|||||TWO_SIDED|95.0|0.75|1.118|||||Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.118|0.75|
70918322|NCT01308567|141328061|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.948|||||TWO_SIDED|95.0|0.8|1.123|||||Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.123|0.8|
70918323|NCT01308567|141328061|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.047|||||TWO_SIDED|95.0|0.886|1.238|||||Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.238|0.886|
70918324|NCT01308567|141328063|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.189|||||TWO_SIDED|95.0|0.986|1.434|||||Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.434|0.986|
70918325|NCT01308567|141328063|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.189|||||TWO_SIDED|95.0|0.985|1.435|||||Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.435|0.985|
70918326|NCT01308567|141328065|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.121|||||TWO_SIDED|95.0|0.886|1.417|||||Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.417|0.886|
70918327|NCT01308567|141328065|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.014|||||TWO_SIDED|95.0|0.798|1.288|||||Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.288|0.798|
70918328|NCT01112670|141328080|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||ANOVA|||||||0.83
70918329|NCT01112670|141328081|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||ANOVA|||||||0.67
70918330|NCT01112670|141328082|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||ANOVA|||||||0.90
70918331|NCT01112670|141328083|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||ANOVA|||||||0.56
70918332|NCT01112670|141328084|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||ANOVA|||||||0.97
70918333|NCT01112670|141328085|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||ANOVA|||||||0.86
70918334|NCT01112670|141328086|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||ANOVA|||||||0.21
70918335|NCT01112670|141328087|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANOVA|||||||0.22
71093204|NCT03806296|141693628|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.592|TWO_SIDED|95.0|-0.03|0.06|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||0.06|-0.03|0.592
70918336|NCT01112670|141328088|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||||||0.14
70918337|NCT01112670|141328089|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||ANOVA|||||||0.29
70918338|NCT01112670|141328090|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||ANOVA|||||||0.43
70918339|NCT00779870|141328093|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
70918340|NCT00779870|141328093|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
71093205|NCT03806296|141693628|SUPERIORITY||Time X Group interaction|-0.03||||0.55|TWO_SIDED|95.0|-0.11|0.06|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoint, and sex.||0.06|-0.11|0.550
70918341|NCT01149369|141328095|NON_INFERIORITY_OR_EQUIVALENCE|P-values, relative risk ratios, and 95% confidence limits (CI) for the primary ITT were calculated using the Cochran-Mantel-Haenszel chi-square test, stratified by clinic.|Risk Ratio (RR)|1.2||||0.43|TWO_SIDED|95.0|0.8|1.7|||Cochran-Mantel-Haenszel|Stratified by clinic||Either 1) improvement in mean of available nausea VAS scores over 28-day treatment period compared to means of VAS during the 7-day baseline (BL) period being ≤ -25 mm, or 2) mean VAS after 28-days of treatment was \< 25 mm.||1.7|0.8|0.43
70918342|NCT01149369|141328096|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-1.5||||0.03|TWO_SIDED|95.0|-2.8|-0.1|||ANCOVA|||||-0.1|-2.8|0.03
70918343|NCT01149369|141328097|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.01||||0.94|TWO_SIDED|95.0|-0.3|0.3|||ANCOVA|||||0.3|-0.3|0.94
70918344|NCT01149369|141328098|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.1||||0.73|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||||0.6|-0.4|0.73
70918345|NCT01149369|141328099|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.2||||0.22|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.22
70918346|NCT01149369|141328100|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.06|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||0.0|-0.6|0.06
70918347|NCT01149369|141328101|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.1||||0.24|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||||0.1|-0.3|0.24
70918348|NCT01149369|141328102|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.01|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|||||-0.1|-0.7|0.01
70918349|NCT01149369|141328103|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.2||||0.22|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.22
70918350|NCT01149369|141328104|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.03||||0.51|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||||0.1|-0.1|0.51
70918351|NCT01149369|141328105|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.2||||0.12|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|0.12
70918352|NCT01149369|141328106|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.02|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|||||-0.1|-0.6|0.02
70918353|NCT01149369|141328107|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.3||||0.17|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||||0.7|-0.1|0.17
70918354|NCT01149369|141328108|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|2.6||||0.59|TWO_SIDED|95.0|-7.0|12.2|||ANCOVA|||||12.2|-7.0|0.59
70918355|NCT01149369|141328109|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|2.1||||0.61|TWO_SIDED|95.0|-5.9|10.0|||ANCOVA|||||10.0|-5.9|0.61
71153947|NCT00488683|141800066|SUPERIORITY_OR_OTHER||R-square|0.1||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup A||||
70918356|NCT01149369|141328110|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.1||||0.23|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|||||0.2|-0.1|0.23
70918357|NCT01149369|141328111|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.97|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||||0.5|-0.5|0.97
70918358|NCT01149369|141328112|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|3.1||||0.77|TWO_SIDED|95.0|-18.0|24.2|||ANCOVA|||||24.2|-18.0|0.77
71153948|NCT00488683|141800066|SUPERIORITY_OR_OTHER||R-square|0.11||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup C||||
70918359|NCT01149369|141328113|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.1||||0.46|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.46
70918360|NCT01149369|141328114|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.1||||0.44|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|||||0.4|-0.2|0.44
70918361|NCT01149369|141328115|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.1||||0.77|TWO_SIDED|95.0|-0.7|0.9|||ANCOVA|||||0.9|-0.7|0.77
70918362|NCT01149369|141328116|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.1||||0.8|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||||0.5|-0.6|0.80
70918363|NCT01149369|141328117|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.88|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||||0.1|-0.1|0.88
70918364|NCT01149369|141328118|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-10.9||||0.17|TWO_SIDED|95.0|-26.5|4.7|||ANCOVA|||||4.7|-26.5|0.17
70918365|NCT01149369|141328119|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.7||||0.07|TWO_SIDED|95.0|-1.5|0.0|||ANCOVA|||||0.0|-1.5|0.07
70918366|NCT01149369|141328120|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.3||||0.53|TWO_SIDED|95.0|-0.7|1.3|||ANCOVA|||||1.3|-0.7|0.53
70918367|NCT01149369|141328121|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.93|TWO_SIDED|95.0|-0.9|1.0|||ANCOVA|||||1.0|-0.9|0.93
70918368|NCT01149369|141328122|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.52|TWO_SIDED|95.0|-1.0|0.2|||ANCOVA|||||0.2|-1.0|0.52
70918369|NCT01149369|141328123|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.76|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||||0.1|-0.1|0.76
70918370|NCT01149369|141328124|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.45|TWO_SIDED|95.0|-2.0|0.9|||ANCOVA|||||0.9|-2.0|0.45
70918371|NCT01149369|141328125|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.18|TWO_SIDED|95.0|0.0|0.1|||ANCOVA|||||0.1|0.0|0.18
70918372|NCT01149369|141328126|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.1||||0.008|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA|||||-0|-0.2|0.008
70918373|NCT01149369|141328127|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.6||||0.001|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|||||-0.3|-0.9|0.001
70918374|NCT01149369|141328128|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.2|-0.4|||ANCOVA|||||-0.4|-1.2|<0.001
70918375|NCT01149369|141328129|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.13|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||||0.1|-0.7|0.13
70918376|NCT01149369|141328130|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.6||||0.004|TWO_SIDED|95.0|-1.2|-0.2|||ANCOVA|||||-0.2|-1.2|0.004
70918377|NCT01149369|141328131|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.08|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||||0.1|-0.9|0.08
70918378|NCT01149369|141328132|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.007|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|||||-0.1|-0.8|0.007
70918379|NCT01149369|141328133|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.7||||0.005|TWO_SIDED|95.0|-1.3|-0.2|||ANCOVA|||||-0.2|-1.3|0.005
70918380|NCT01149369|141328134|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.7||||0.001|TWO_SIDED|95.0|-1.1|-0.3|||ANCOVA|||||-0.3|-1.1|0.001
70918381|NCT01149369|141328135|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.8||||0.003|TWO_SIDED|95.0|-2.3|-0.3|||ANCOVA|||||-0.3|-2.3|0.003
70918382|NCT01149369|141328136|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.03|TWO_SIDED|95.0|-1.0|-0.1|||ANCOVA|||||-0.1|-1.0|0.03
70918383|NCT01149369|141328137|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.16|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||||0.1|-0.8|0.16
70918384|NCT01149369|141328138|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.05|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||||0.0|-0.9|0.05
70918385|NCT01149369|141328139|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.1||||0.72|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||||0.6|-0.4|0.72
70918386|NCT01149369|141328140|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.8||||0.001|TWO_SIDED|95.0|-1.2|-0.3|||ANCOVA|||||-0.3|-1.2|0.001
70918387|NCT01149369|141328141|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.04|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||||0.0|-0.9|0.04
70918388|NCT01149369|141328142|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.14|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||||0.1|-0.9|0.14
70918389|NCT01149369|141328143|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.07|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|||||0.0|-1.0|0.07
70918390|NCT01149369|141328144|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.19|TWO_SIDED|95.0|-0.8|0.2|||ANCOVA|||||0.2|-0.8|0.19
70918391|NCT01149369|141328145|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.04|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||||-0.0|-0.9|0.04
70918392|NCT01149369|141328146|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.02|TWO_SIDED|95.0|-1.0|-0.1|||ANCOVA|||||-0.1|-1.0|0.02
70918393|NCT01149369|141328147|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.06|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||||0.0|-0.9|0.06
70918394|NCT01149369|141328148|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.09|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||||0.1|-0.8|0.09
70918395|NCT01149369|141328149|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.17|TWO_SIDED|95.0|-7.0|0.1|||ANCOVA|||||0.1|-7|0.17
70918396|NCT01149369|141328150|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.6||||0.009|TWO_SIDED|95.0|-1.1|-0.2|||ANCOVA|||||-0.2|-1.1|0.009
70918397|NCT01149369|141328151|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.7||||0.004|TWO_SIDED|95.0|-1.2|-0.2|||ANCOVA|||||-0.2|-1.2|0.004
70918398|NCT01149369|141328152|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.1|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||||0.1|-0.8|0.10
70918399|NCT01149369|141328153|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.13|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||||0.1|-0.9|0.13
70918400|NCT01149369|141328154|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.01||||0.98|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|||||0.4|-0.5|0.98
70918401|NCT01149369|141328155|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.007|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||||0.1|-0.7|0.007
70918402|NCT01149369|141328156|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.06|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||||0.0|-0.9|0.06
70918403|NCT01149369|141328157|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.6||||0.001|TWO_SIDED|95.0|-1.0|-0.2|||ANCOVA|||||-0.2|-1.0|0.001
70918404|NCT01149369|141328158|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.2||||0.28|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||||0.2|-0.6|0.28
70918405|NCT01149369|141328159|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.05|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|||||0.0|-1.0|0.05
70918406|NCT01149369|141328160|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.08|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||||0.1|-0.9|0.08
70918407|NCT01149369|141328161|SUPERIORITY|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.53|TWO_SIDED|95.0|-1.1|0.6|||ANCOVA|||||0.6|-1.1|0.53
70918408|NCT01149369|141328162|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.38|TWO_SIDED|95.0|-1.3|0.5|||ANCOVA|||||0.5|-1.3|0.38
70918409|NCT01149369|141328163|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-2.2||||0.09|TWO_SIDED|95.0|-4.7|0.4|||ANCOVA|||||0.4|-4.7|0.09
70918410|NCT01149369|141328164|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-1.8||||0.28|TWO_SIDED|95.0|-5.2|1.5|||ANCOVA|||||1.5|-5.2|0.28
70918411|NCT01149369|141328165|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-1.6||||0.3|TWO_SIDED|95.0|-4.6|1.4|||ANCOVA|||||1.4|-4.6|0.30
70918412|NCT01149369|141328166|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-21.2||||0.4|TWO_SIDED|95.0|-70.5|28.1|||ANCOVA|||||28.1|-70.5|0.40
70918413|NCT01149369|141328167|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-4.2||||0.28|TWO_SIDED|95.0|-12.0|3.5|||ANCOVA|||||3.5|-12.0|0.28
70918414|NCT01149369|141328168|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|2.4||||0.47|TWO_SIDED|95.0|-4.1|8.9|||ANCOVA|||||8.9|-4.1|0.47
71093206|NCT03806296|141693629|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.55|TWO_SIDED|95.0|-0.07|0.04|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||0.04|-0.07|0.550
70918415|NCT01149369|141328169|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|1.2||||0.68|TWO_SIDED|95.0|-4.5|6.9|||ANCOVA|||||6.9|-4.5|0.68
70918416|NCT01149369|141328170|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|2.0||||0.48|TWO_SIDED|95.0|-3.6|7.6|||ANCOVA|||||7.6|-3.6|0.48
70918417|NCT01149369|141328171|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|1.5||||0.43|TWO_SIDED|95.0|-2.2|5.1|||ANCOVA|||||5.1|-2.2|0.43
70918418|NCT01149369|141328172|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-4.8||||0.01|TWO_SIDED|95.0|-8.5|-1.2|||ANCOVA|||||-1.2|-8.5|0.01
70918419|NCT01149369|141328173|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|1.4||||0.57|TWO_SIDED|95.0|-3.4|6.1|||ANCOVA|||||6.1|-3.4|0.57
70918420|NCT01149369|141328174|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.84||||0.34|TWO_SIDED|95.0|-2.6|1.0|||ANCOVA|||||1.0|-2.6|0.34
70918421|NCT01636687|141328180|SUPERIORITY_OR_OTHER||Risk Difference (RD)|53.3|||<|0.0001|TWO_SIDED|95.0|36.6|67.7|||Fisher Exact|||Response criterion: IGA 0/1||67.7|36.6|<0.0001
70918422|NCT01636687|141328180|SUPERIORITY_OR_OTHER||Risk Difference (RD)|73.3|||<|0.0001|TWO_SIDED|95.0|58.8|83.9|||Fisher Exact|||Response Criterion: IGA 0/1||83.9|58.8|<0.0001
70918423|NCT01636687|141328180|SUPERIORITY_OR_OTHER||Risk Difference (RD)|68.4|||<|0.0001|TWO_SIDED|95.0|53.1|79.8|||Fisher Exact|||Response criterion: PASI 75||79.8|53.1|<0.0001
70918424|NCT01636687|141328180|SUPERIORITY_OR_OTHER||Risk Difference (RD)|83.4|||<|0.0001|TWO_SIDED|95.0|70.7|91.7|||Fisher Exact|||Response criterion: PASI 75||91.7|70.7|<0.0001
70918425|NCT03482011|141328216|SUPERIORITY||Risk Difference (RD)|63.0|||<|0.001|TWO_SIDED|95.0|56.5|69.4|||Cochran-Mantel-Haenszel|||||69.4|56.5|<0.001
70918426|NCT03482011|141328217|SUPERIORITY||Risk Difference (RD)|57.8|||<|0.001|TWO_SIDED|95.0|51.3|64.4|||Cochran-Mantel-Haenszel|||||64.4|51.3|<0.001
70918427|NCT03482011|141328218|SUPERIORITY||Risk Difference (RD)|15.6|||<|0.001|TWO_SIDED|95.0|11.6|19.7|||Cochran-Mantel-Haenszel|||||19.7|11.6|<0.001
70918428|NCT03482011|141328219|SUPERIORITY||Risk Difference (RD)|73.6|||<|0.001|TWO_SIDED|95.0|67.1|80.1|||Cochran-Mantel-Haenszel|||||80.1|67.1|<0.001
70918429|NCT03482011|141328220|SUPERIORITY||Risk Difference (RD)|30.8|||<|0.001|TWO_SIDED|95.0|26.0|35.7|||Cochran-Mantel-Haenszel|||||35.7|26.0|<0.001
70918430|NCT03482011|141328221|SUPERIORITY||Risk Difference (RD)|48.1|||<|0.001|TWO_SIDED|95.0|42.9|53.2|||Cochran-Mantel-Haenszel|||||53.2|42.9|<0.001
70918431|NCT03482011|141328222|SUPERIORITY||Risk Difference (RD)|18.3|||<|0.001|TWO_SIDED|95.0|14.5|22.1|||Cochran-Mantel-Haenszel|||||22.1|14.5|<0.001
70918432|NCT03482011|141328223|SUPERIORITY||Risk Difference (RD)|49.6|||<|0.001|TWO_SIDED|95.0|42.8|56.4|||Cochran-Mantel-Haenszel|||||56.4|42.8|<0.001
70918433|NCT03482011|141328224|SUPERIORITY||Risk Difference (RD)|66.7|||<|0.001|TWO_SIDED|95.0|56.0|77.5|||Cochran-Mantel-Haenszel|||||77.5|56.0|<0.001
70918434|NCT03482011|141328224|SUPERIORITY||Risk Difference (RD)|65.9|||<|0.001|TWO_SIDED|95.0|54.9|77.0|||Cochran-Mantel-Haenszel|||||77.0|54.9|<0.001
70918435|NCT03482011|141328225|SUPERIORITY||Mean Difference (Net)|-4.7|STANDARD_ERROR_OF_MEAN|1.32|<|0.001|TWO_SIDED|95.0|-7.31|-2.1|||Mixed Models Analysis|||||-2.10|-7.31|<0.001
70918436|NCT03482011|141328226|SUPERIORITY||Mean Difference (Net)|-17.33|STANDARD_ERROR_OF_MEAN|0.99|<|0.001|TWO_SIDED|95.0|-19.28|-15.39|||Mixed Models Analysis|||||-15.39|-19.28|<0.001
70918437|NCT03482011|141328227|SUPERIORITY||Mean Difference (Net)|-6.98|STANDARD_ERROR_OF_MEAN|1.73|<|0.001|TWO_SIDED|95.0|-10.37|-3.58|||Mixed Models Analysis|||||-3.58|-10.37|<0.001
70918438|NCT03482011|141328228|SUPERIORITY||Mean Difference (Net)|4.86|STANDARD_ERROR_OF_MEAN|0.69|<|0.001|TWO_SIDED|95.0|3.5|6.22|||ANCOVA|||||6.22|3.50|<0.001
70918439|NCT03482011|141328229|SUPERIORITY||Mean Difference (Net)|4.78|STANDARD_ERROR_OF_MEAN|0.74|<|0.001|TWO_SIDED|95.0|3.33|6.23|||ANCOVA|||||6.23|3.33|<0.001
70918440|NCT03482011|141328230|SUPERIORITY||Risk Difference (RD)|68.1|||<|0.001|TWO_SIDED|95.0|63.2|72.9|||Cochran-Mantel-Haenszel|||||72.9|63.2|<0.001
70918441|NCT03482011|141328231|SUPERIORITY||Mean Difference (Net)|-3.68|STANDARD_ERROR_OF_MEAN|1.84||0.002|TWO_SIDED|95.0|-7.3|-0.06|||ANOVA|||Absenteeism||-0.06|-7.30|0.002
70918442|NCT03482011|141328231|SUPERIORITY||Mean Difference (Net)|-20.24|STANDARD_ERROR_OF_MEAN|2.37|<|0.001|TWO_SIDED|95.0|-24.89|-15.6|||ANCOVA|||Presenteeism||-15.60|-24.89|<0.001
70918443|NCT03482011|141328231|SUPERIORITY||Mean Difference (Net)|-21.09|STANDARD_ERROR_OF_MEAN|2.78|<|0.001|TWO_SIDED|95.0|-26.56|-15.62|||ANCOVA|||Overall Absenteeism and Presenteeism||-15.62|-26.56|<0.001
70918444|NCT03482011|141328231|SUPERIORITY||Mean Difference (Net)|-22.91|STANDARD_ERROR_OF_MEAN|2.28|<|0.001|TWO_SIDED|95.0|-27.39|-18.43|||ANCOVA|||Impairment in Activities Performed Outside of Work||-18.43|-27.39|<0.001
70918445|NCT03482011|141328232|SUPERIORITY||Mean Difference (Net)|0.53|STANDARD_ERROR_OF_MEAN|1.79||0.004|TWO_SIDED|95.0|-3.08|4.14|||ANCOVA|||||4.14|-3.08|0.004
70918446|NCT03482011|141328233|SUPERIORITY||Risk Difference (RD)|48.8|||<|0.001|TWO_SIDED|95.0|41.6|55.9|||Cochran-Mantel-Haenszel|||||55.9|41.6|<0.001
70918447|NCT06243796|141328264|SUPERIORITY||||||<|0.005|||||||t-test, 2 sided|||||||<0.005
70918448|NCT06243796|141328265|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
70970793|NCT01157078|141447242|SUPERIORITY_OR_OTHER||LS mean|-0.7|STANDARD_ERROR_OF_MEAN|0.97||0.501|TWO_SIDED|95.0|-2.56|1.25|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects the model; pooled center is a random effect.||1.25|-2.56|0.501
71093207|NCT03806296|141693629|SUPERIORITY||Time X Group interaction|-0.02||||0.556|TWO_SIDED|95.0|-0.1|0.06|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoint, and sex.||0.06|-0.10|0.556
70970794|NCT01157078|141447243|SUPERIORITY_OR_OTHER||LS mean|-0.62|STANDARD_ERROR_OF_MEAN|0.771||0.424|TWO_SIDED|95.0|-2.134|0.901||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.901|-2.134|0.424
70970795|NCT01157078|141447244|SUPERIORITY_OR_OTHER||LS mean|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.214|TWO_SIDED|95.0|-0.96|0.22||Analysis for change in SDS work/school domain score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.22|-0.96|0.214
70970796|NCT01157078|141447245|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.29||0.931|TWO_SIDED|95.0|-0.59|0.54|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.54|-0.59|0.931
70970797|NCT01157078|141447246|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.755|TWO_SIDED|95.0|-0.6|0.44|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.44|-0.60|0.755
70970798|NCT01157078|141447247|SUPERIORITY_OR_OTHER||LS mean|0.82|STANDARD_ERROR_OF_MEAN|1.789||0.646|TWO_SIDED|95.0|-2.699|4.346|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||4.346|-2.699|0.646
70918454|NCT00262730|141328280|NON_INFERIORITY_OR_EQUIVALENCE|study design has 85% power to detect 25% deduction in hazard rate compared to EORTC Phase 3 results.|Hazard Ratio (HR)|0.8|STANDARD_DEVIATION|0.025|>|0.1|TWO_SIDED|95.0|0.8|0.85|||Log Rank|||||0.85|0.8|>.1
70918455|NCT05714696|141328290|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||.007
70918456|NCT05714696|141328291|SUPERIORITY|||||||0.049|||||||t-test, 2 sided|||||||.049
70918457|NCT05714696|141328292|SUPERIORITY|||||||0.029|||||||t-test, 2 sided|||||||.029
70918458|NCT05714696|141328293|SUPERIORITY|||||||0.163|||||||t-test, 2 sided|||||||.163
70918459|NCT05714696|141328294|SUPERIORITY|||||||0.442|||||||t-test, 2 sided|||||||.442
70918460|NCT05714696|141328296|SUPERIORITY|||||||0.527|||||||t-test, 2 sided|||||||.527
70918461|NCT05714696|141328297|SUPERIORITY|||||||0.311|||||||t-test, 2 sided|||||||.311
70918462|NCT05714696|141328298|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||.004
70918463|NCT05714696|141328299|SUPERIORITY|||||||0.005|||||||Chi-squared|||||||.005
70918464|NCT01641198|141328340|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.115|<|0.05|TWO_SIDED|95.0|-0.59|0.01||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SW estimated with the mixed linear model (mean±SE, 95% CI)||0.01|-0.59|<0.05
70918465|NCT01641198|141328340|SUPERIORITY||Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED|95.0|0.09|0.69||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SC estimated with the mixed linear model (mean±SE, 95% CI)||0.69|0.09|<0.05
70918466|NCT01641198|141328340|SUPERIORITY||Mean Difference (Final Values)|-0.685|STANDARD_ERROR_OF_MEAN|0.115|<|0.05|TWO_SIDED|95.0|-0.98|-0.39||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between SW and SC estimated with the mixed linear model (mean±SE, 95% CI)||-0.39|-0.98|<0.05
70918467|NCT01641198|141328341|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.135|<|0.05|TWO_SIDED|95.0|-0.47|0.13||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SW estimated with the mixed linear model (mean±SE, 95% CI)||0.13|-0.47|<0.05
70970799|NCT01157078|141447248|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.446|TWO_SIDED|95.0|-0.31|0.14|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.14|-0.31|0.446
70970800|NCT01157078|141447249|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.178|TWO_SIDED|95.0|-0.06|0.33|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.33|-0.06|0.178
71153949|NCT00488683|141800066|SUPERIORITY_OR_OTHER||R-square|0.06||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup C||||
70918468|NCT01641198|141328341|SUPERIORITY||Mean Difference (Final Values)|0.56|STANDARD_ERROR_OF_MEAN|0.13|<|0.05|TWO_SIDED|95.0|0.26|0.85||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SC estimated with the mixed linear model (mean±SE, 95% CI)||0.85|0.26|<0.05
70918469|NCT01641198|141328341|SUPERIORITY||Mean Difference (Final Values)|-0.725|STANDARD_ERROR_OF_MEAN|0.135|<|0.05|TWO_SIDED|95.0|-1.02|-0.43||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between SW and SC estimated with the mixed linear model (mean±SE, 95% CI)||-0.43|-1.02|<0.05
70918470|NCT01641198|141328342|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.05|TWO_SIDED|95.0|-0.19|0.59||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SW estimated with the mixed linear model (mean±SE, 95% CI)||0.59|-0.19|<0.05
70918471|NCT01641198|141328342|SUPERIORITY||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.2|<|0.05|TWO_SIDED|95.0|0.45|1.22||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SC estimated with the mixed linear model (mean±SE, 95% CI)||1.22|0.45|<0.05
70918472|NCT01641198|141328342|SUPERIORITY||Mean Difference (Final Values)|-0.635|STANDARD_ERROR_OF_MEAN|0.2|<|0.05|TWO_SIDED|95.0|-1.01|-0.26||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between SW and SC estimated with the mixed linear model (mean±SE, 95% CI).||-0.26|-1.01|<0.05
70918473|NCT02594735|141328350|OTHER|||||||0.002|||||||t-test, 2 sided|||||||0.002
70918474|NCT02594735|141328351|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70918475|NCT02594735|141328352|OTHER|||||||0.004|||||||t-test, 2 sided|||||||0.004
70918476|NCT02594735|141328353|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70918477|NCT02594735|141328354|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70918478|NCT02594735|141328355|OTHER|||||||0.375|||||||t-test, 2 sided|||||||0.375
70918479|NCT02594735|141328356|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70918480|NCT02594735|141328357|OTHER|||||||0.044|||||||Sign test|Data was not normally distributed||||||0.044
70918481|NCT02594735|141328358|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
70918482|NCT01075217|141328397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|STANDARD_DEVIATION|2.45|<|0.0001|TWO_SIDED|95.0|1.4|3.5||P-value provided is for the difference in pain assessment between Isovue and Visipaque in Group 1, i.e., pain was not assessed separately from heat.|t-test, 2 sided|||||3.5|1.4|<0.0001
70918483|NCT01075217|141328397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_DEVIATION|1.94||0.3244|TWO_SIDED|95.0|-0.5|1.4||P-value provided is for the difference in pain assessment between Isovue and Visipaque in Group 2, i.e., pain was assessed separately from heat.|t-test, 2 sided|||||1.4|-0.5|0.3244
70918484|NCT01075217|141328398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|STANDARD_DEVIATION|2.35||0.0059|TWO_SIDED|95.0|0.5|2.7|||t-test, 2 sided|||||2.7|0.5|0.0059
70918485|NCT01068743|141328430|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% confidence intervals (CIs) for the test-to-reference ratios (B/A) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of saxagliptin.|Ratio (%) of Geometric LS Means|101.45|||||TWO_SIDED|90.0|98.17|104.84|||||Ratio=Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries. LS=Least Squares.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 98% and 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf, respectively. If there was a 5% difference, then 20 participants would have provided 93% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||104.84|98.17|
70918486|NCT01068743|141328430|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of saxagliptin.|Ratio (%) of Geometric LS Means|102.43|||||TWO_SIDED|90.0|99.53|105.42|||||Ratio=Treatment D/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 98% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively. If there was a 5% difference, then 20 participants would have provided 93% and 99% power to conclude BE with respect to Cmax and AUC0-inf,respectively.||105.42|99.53|
70918487|NCT01068743|141328430|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|49.23||||||||||||||Geometric least squares means for Treatment A.||||
70918488|NCT01068743|141328430|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|49.94||||||||||||||Geometric least squares means for Treatment B.||||
70918489|NCT01068743|141328430|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|52.71||||||||||||||Geometric least squares means for Treatment C.||||
70918490|NCT01068743|141328430|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|53.99||||||||||||||Geometric least squares means for Treatment D.||||
70970801|NCT01157078|141447250|SUPERIORITY_OR_OTHER||LS Mean|-1.1|STANDARD_ERROR_OF_MEAN|1.61||0.515|TWO_SIDED|95.0|-4.22|2.12|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SIS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.12|-4.22|0.515
71093208|NCT03806296|141693630|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.124|TWO_SIDED|95.0|-0.01|0.06|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||0.06|-0.01|0.124
71093209|NCT03806296|141693630|SUPERIORITY||Time X Group interaction|0.0||||0.925|TWO_SIDED|95.0|-0.05|0.06|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoint, and sex.||0.06|-0.05|0.925
71093210|NCT03806296|141693631|SUPERIORITY||Risk Ratio (RR)|0.752||||0.42|TWO_SIDED|95.0|0.374|1.513|||Poisson GLM with robust standard error||Early/Middle Sleep group was the reference group (lower RR indicates less likelihood of cannabis use in the Late Sleep group)|For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a Poisson generalized linear model (GLM) to test the effect of group (Early/Mid vs Late) on a binary cannabis use outcome (yes/no in the past 3 months), accounting for age and sex.||1.513|0.374|0.42
71093211|NCT03806296|141693632|SUPERIORITY||Risk Ratio (RR)|1.236||||0.461|TWO_SIDED|95.0|0.704|2.171|||Poisson GLM with robust standard error||Early/Middle Sleep group was the reference group (higher RR indicates higher likelihood of alcohol use in the Late Sleep group)|For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a Poisson generalized linear model (GLM) to test the effect of group (Early/Mid vs Late) on a binary alcohol use outcome (yes/no in the past 3 months), accounting for age and sex.||2.171|0.704|0.461
71093212|NCT03806296|141693632|SUPERIORITY||Incident Rate Ratio|3.29||||0.007|TWO_SIDED|95.0|1.36|7.9|||negative binomial glm||Early/Middle Sleep group was the reference group (higher IRR indicates greater days of alcohol use in the Late Sleep group than in the Early/Middle Sleep group).|For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a negative binomial GLM to test the effect of group (Early/Mid vs Late) on days of alcohol use, accounting for age and sex.||7.90|1.36|0.007
71093213|NCT00876343|141693633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.006|TWO_SIDED|95.0|-3.7|-0.6|||ANCOVA|||||-0.6|-3.7|0.006
71093214|NCT00876343|141693633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|||<|0.001|TWO_SIDED|95.0|-4.6|-1.5|||ANCOVA|||||-1.5|-4.6|<0.001
71093215|NCT04896385|141693637|OTHER|||||||0.004|||||||repeated measures correlation|||F-VASI||||0.004
70918491|NCT01068743|141328433|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (B/A) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of saxagliptin.|Ratio (%) of Geometric LS Means|102.46|||||TWO_SIDED|90.0|94.68|110.88|||||Ratio=Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 98% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively. If there was a 5% difference, then 20 participants would have provided 93% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||110.88|94.68|
71093216|NCT04896385|141693637|OTHER|||||||0.41|||||||repeated measures correlation|||F-VASI||||0.41
70918492|NCT01068743|141328433|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of saxagliptin.|Ratio (%) of Geometric LS Means|106.24|||||TWO_SIDED|90.0|98.43|114.66|||||Ratio=Treatment D/Treatment C. Geometric least squares means values presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 98% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively. If there was a 5% difference, then 20 participants would have provided 93% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||114.66|98.43|
70918493|NCT01068743|141328433|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|9.73||||||||||||||Geometric least squares means for Treatment A.||||
71093217|NCT04896385|141693637|OTHER|||||||0.0002|||||||repeated measures correlation|||T-VASI||||0.0002
71093218|NCT04896385|141693637|OTHER|||||||0.91|||||||repeated measures correlation|||T-VASI||||0.91
71093219|NCT05258721|141693642|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71093220|NCT05258721|141693643|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p =0.05|Kruskal-Wallis|||||||<0.001
71093221|NCT05258721|141693644|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
71093222|NCT00230737|141693663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3594.0|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71093223|NCT00848185|141693664|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||ANOVA for three groups||||<0.001
71093224|NCT00790036|141693724|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.276|TWO_SIDED|95.0|0.69|1.22||P-value was obtained from the one-sided unstratified log rank test.|Log Rank|||||1.22|0.69|0.276
71093225|NCT00790036|141693725|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.52|1.09||There was no formal testing of the OS between treatment since the primary endpoint was not statistically significant.||||||1.09|0.52|
71093226|NCT00790036|141693726|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.41|1.07||||||||1.07|0.41|
71153950|NCT00488683|141800066|SUPERIORITY_OR_OTHER||R-square|0.17||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||
70918494|NCT01068743|141328433|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|9.97||||||||||||||Geometric least squares means for Treatment B.||||
70918495|NCT01068743|141328433|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|10.33||||||||||||||Geometric least squares means for Treatment C.||||
70918496|NCT01068743|141328433|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|10.97||||||||||||||Geometric least squares means for Treatment D.||||
70918497|NCT01068743|141328434|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (B/A) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of metformin.|Ratio (%) of Geometric LS Means|102.1|||||TWO_SIDED|90.0|97.26|107.18|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 99% power to conclude BE with respect to each of Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would provide 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||107.18|97.26|
70918498|NCT01068743|141328434|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (B/A) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of metformin.|Ratio (%) of Geometric LS Means|99.17|||||TWO_SIDED|90.0|96.23|102.21|||||Ratio=Treatment D/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 99% power to conclude BE with respect to each of Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would provide 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||102.21|96.23|
70918499|NCT01068743|141328434|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|11998.0||||||||||||||Geometric least squares mean for Treatment A.||||
70918500|NCT01068743|141328434|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|12250.0||||||||||||||Geometric least squares means for Treatment B.||||
70918501|NCT01068743|141328434|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|12036.0||||||||||||||Geometric least squares means for Treatment C.||||
70918502|NCT01068743|141328434|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|11937.0||||||||||||||Geometric least squares means for Treatment D.||||
70918503|NCT01068743|141328435|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (B/A) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of metformin.|Ratio (%) of Geometric LS Means|99.5|||||TWO_SIDED|90.0|90.41|109.5|||||Ratio=Treatment B/Treatment A. Geometric least squares means values presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 99% power to conclude BE with respect to each of Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would provide 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||109.5|90.41|
70918504|NCT01068743|141328435|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of metformin.|Ratio (%) of Geometric LS Means|98.22|||||TWO_SIDED|90.0|94.28|102.32|||||Ratio=Treatment D/Treatment C. Geometric least squares means values presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 99% power to conclude BE with respect to each of Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would provide 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||102.32|94.28|
70918505|NCT01068743|141328435|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL|1724.4||||||||||||||Geometric least squares means for Treatment A.||||
70918506|NCT01068743|141328435|SUPERIORITY_OR_OTHER||Geometric Least Square Means (ng/mL)|1715.8||||||||||||||Geometric least squares means for Treatment B.||||
70918507|NCT01068743|141328435|SUPERIORITY_OR_OTHER||Geometric Least Square Mean (ng/mL)|1581.4||||||||||||||Geometric least squares means for Treatment C.||||
70918508|NCT01068743|141328435|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|1553.2||||||||||||||Geometric least squares means for Treatment D.||||
70918509|NCT01068743|141328440|SUPERIORITY_OR_OTHER||Ratio (%) of Geometric LS Means|101.43|||||TWO_SIDED|90.0|98.07|104.9|||||Ratio=Treatment B/Treatment A. Geometric least squares means values presented in other statistical analysis entries.|||104.90|98.07|
70918510|NCT01068743|141328440|SUPERIORITY_OR_OTHER||Ratio (%) of Geometric LS Means|102.52|||||TWO_SIDED|90.0|99.56|105.57|||||Ratio=Treatment D/Treatment C. Geometric least squares means values presented in other statistical analysis entries.|||105.57|99.56|
70918511|NCT01068743|141328440|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|47.15|||||||||||||Geometric least squares means for Treatment A.|||||
70918512|NCT01068743|141328440|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|47.83|||||||||||||Geometric least squares means for Treatment B.|||||
70918513|NCT01068743|141328440|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|50.89|||||||||||||Geometric least squares means for Treatment C.|||||
70918514|NCT01068743|141328440|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|52.17|||||||||||||Geometric least squares means for Treatment D.|||||
70918515|NCT01068743|141328443|SUPERIORITY_OR_OTHER||Ratio (%) of Geometric LS Means|100.41|||||TWO_SIDED|90.0|95.4|105.68|||||Ratio=Treatment B/Treatment A. Geometric least squares means values presented in other statistical analysis entries.|||105.68|95.40|
70918516|NCT01068743|141328443|SUPERIORITY_OR_OTHER||Ratio (%) of Geometric LS Means|99.06|||||TWO_SIDED|90.0|96.19|102.02|||||Ratio=Treatment D/Treatment C. Geometric least squares means values presented in other statistical analysis entries.|||102.02|96.19|
70918517|NCT01068743|141328443|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|11827.0|||||||||||||Geometric least squares means for Treatment A.|||||
70918518|NCT01068743|141328443|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|11875.0|||||||||||||Geometric least squares means for Treatment B.|||||
70918519|NCT01068743|141328443|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|11845.0|||||||||||||Geometric least squares means for Treatment C.|||||
70918520|NCT01068743|141328443|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|11734.0|||||||||||||Geometric least squares means for Treatment D.|||||
70918521|NCT00364013|141328447|SUPERIORITY_OR_OTHER_LEGACY||Normal score|-2.27||||0.0234||||||P-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).|Stratified log-rank test||A normal score \<0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer progression-free survival time.|PFS in the Wild-type KRAS Efficacy Analysis Set was compared at a significance level of 5%.||||0.0234
70918522|NCT00364013|141328447|SUPERIORITY_OR_OTHER_LEGACY||Normal score|2.28||||0.0227||||||P-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).|Stratified log-rank test||A normal score \<0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer progression-free survival time.|PFS in the Mutant KRAS Efficacy Analysis Set was compared at a significance level of 5% conditional on first demonstrating a significant treatment effect in PFS in the Wild-type KRAS Efficacy Analysis Set.||||0.0227
70918523|NCT00364013|141328448|SUPERIORITY_OR_OTHER_LEGACY||Normal score|-1.8||||0.0723||||||cP-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).|Stratified log-rank test||A normal score \<0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer overall survival time.|Overall survival comparisons in the wild-type KRAS Efficacy Analysis Set was performed at a significance level of 4.99% conditional on a statistically significant difference for PFS in the Wild-type KRAS Efficacy Analysis Set.||||0.0723
70918524|NCT00364013|141328448|SUPERIORITY_OR_OTHER_LEGACY||Normal score|1.83||||0.0678||||||P-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).|Stratified log-rank test||A normal score \<0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer overall survival time.|Overall survival comparisons in the mutant KRAS Efficacy Analysis Set was performed at an significance level of 4.99% conditional on a statistically significant difference for PFS in the Mutant KRAS Efficacy Analysis Set.||||0.0678
70918525|NCT00364013|141328449|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.35||||0.0684|TWO_SIDED|95.0|0.98|1.87|||Stratified exact test|Adjusted for geographic region and ECOG score.|The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFOX alone arm.|||1.87|0.98|0.0684
70918526|NCT00364013|141328449|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.98||||0.9822|TWO_SIDED|95.0|0.65|1.47|||Stratified exact test|Adjusted for geographic region and ECOG score|The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFOX alone arm.|||1.47|0.65|0.9822
70918527|NCT01499654|141328555|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.001
70918528|NCT01499654|141328555|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.67
70918529|NCT01499654|141328556|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70918530|NCT01499654|141328556|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.002
70918531|NCT01499654|141328557|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70918532|NCT01499654|141328557|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.08
70918533|NCT01499654|141328558|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.006
70918534|NCT01499654|141328558|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.44
70918535|NCT01395758|141328579|SUPERIORITY|||||||0.5017|||||||Log Rank|||||||0.5017
70918536|NCT01395758|141328580|SUPERIORITY|||||||0.4356|||||||Log Rank|||||||0.4356
70918537|NCT00357097|141328583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6|||<|0.001||95.0|-5.6|-1.6|||ANCOVA||Mean difference = Ropinirole minus Placebo. Used adjusted change from baseline.|||-1.6|-5.6|<0.001
70918538|NCT02528188|141328670|SUPERIORITY||Risk Difference (RD)|2.39||||0.0123|TWO_SIDED|95.0|0.58|4.68|||Exact methods for risk difference|||||4.68|0.58|0.0123
70918539|NCT02528188|141328670|SUPERIORITY||Risk Difference (RD)|5.61|||<|0.0001|TWO_SIDED|95.0|3.55|8.14|||Exact methods for risk difference|||||8.14|3.55|<0.0001
70918540|NCT02528188|141328671|SUPERIORITY||Rate Difference|23.5||||0.0012|TWO_SIDED|95.0|9.3|37.7|||Poisson model for rate difference|||||37.7|9.3|0.0012
70918541|NCT02528188|141328671|SUPERIORITY||Rate Difference|56.7|||<|0.0001|TWO_SIDED|95.0|38.4|74.9|||Poisson model for rate difference|||||74.9|38.4|<0.0001
70918542|NCT02528188|141328672|SUPERIORITY|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (\>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.11||0.0148|TWO_SIDED|95.0|-0.46|-0.05||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.46|0.0148
70918543|NCT02528188|141328672|SUPERIORITY|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (\>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.11||0.1597|TWO_SIDED|95.0|-0.36|0.06||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. Analysis of covariance (ANCOVA) model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.06|-0.36|0.1597
70918544|NCT02528188|141328673|SUPERIORITY|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (\>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.1||0.003|TWO_SIDED|95.0|-0.52|-0.11||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.11|-0.52|0.0030
70918545|NCT02528188|141328673|SUPERIORITY|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (\>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.11||0.0691|TWO_SIDED|95.0|-0.4|0.02||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.02|-0.40|0.0691
70918546|NCT02528188|141328674|SUPERIORITY|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (\>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.04||0.3431|TWO_SIDED|95.0|-0.11|0.04||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.04|-0.11|0.3431
70918547|NCT02528188|141328674|SUPERIORITY|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (\>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.6332|TWO_SIDED|95.0|-0.09|0.06||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.06|-0.09|0.6332
70918548|NCT02528188|141328675|SUPERIORITY||Risk Difference (RD)|0.5||||0.4082|TWO_SIDED|95.0|-0.75|2.28|||Exact methods for risk difference|||||2.28|-0.75|0.4082
70918549|NCT02528188|141328675|SUPERIORITY||Risk Difference (RD)|1.7||||0.0238|TWO_SIDED|95.0|0.31|3.63|||Exact methods for risk difference|||||3.63|0.31|0.0238
70918550|NCT02528188|141328676|SUPERIORITY||Rate Difference|4.8||||0.2035|TWO_SIDED|95.0|-2.6|12.2|||Poisson model for rate difference|||||12.2|-2.6|0.2035
70918551|NCT02528188|141328676|SUPERIORITY||Rate Difference|16.9||||0.001|TWO_SIDED|95.0|6.8|27.0|||Poisson model for rate difference|||||27.0|6.8|0.0010
70918552|NCT02528188|141328677|SUPERIORITY||Risk Difference|1.99||||0.0248|TWO_SIDED|95.0|0.31|4.17|||Exact methods for risk difference|||Rapidly progressive OA Type 1 or 2||4.17|0.31|0.0248
70918553|NCT02528188|141328677|SUPERIORITY||Risk difference|5.11|||<|0.0001|TWO_SIDED|95.0|3.16|7.54|||Exact methods for risk difference|||Rapidly Progressive OA Type 1 or 2||7.54|3.16|<0.0001
70918554|NCT02528188|141328677|SUPERIORITY||Risk difference|1.79||||0.0366|TWO_SIDED|95.0|0.16|3.92|||Exact methods for risk difference|||Rapidly Progressive OA Type 1||3.92|0.16|0.0366
70918555|NCT02528188|141328677|SUPERIORITY||Risk difference|3.81||||0.0001|TWO_SIDED|95.0|1.99|6.12|||Exact methods for risk difference|||Rapidly Progressive OA Type 1||6.12|1.99|0.0001
70918556|NCT02528188|141328677|SUPERIORITY||Risk difference|0.2||||0.6168|TWO_SIDED|95.0|-0.76|1.71|||Exact methods for risk difference|||Rapidly Progressive OA Type 2||1.71|-0.76|0.6168
70918557|NCT02528188|141328677|SUPERIORITY||Risk difference|1.3||||0.0388|TWO_SIDED|95.0|0.17|2.97|||Exact methods for risk difference|||Rapidly Progressive OA Type 2||2.97|0.17|0.0388
70918558|NCT02528188|141328677|SUPERIORITY||Risk difference|0.1||||0.7245|TWO_SIDED|95.0|-0.74|1.51|||Exact methods for risk difference|||Primary osteonecrosis||1.51|-0.74|0.7245
70918559|NCT02528188|141328677|SUPERIORITY||Risk difference|0.1||||0.7182|TWO_SIDED|95.0|-0.74|1.52|||Exact methods for risk difference|||Primary osteonecrosis||1.52|-0.74|0.7182
70918560|NCT02528188|141328677|SUPERIORITY||Risk difference|0.2||||0.6824|TWO_SIDED|95.0|-0.96|1.9|||Exact methods for risk difference|||Subchondral insufficiency fracture||1.90|-0.96|0.6824
70918561|NCT02528188|141328677|SUPERIORITY||Risk difference|0.3||||0.5632|TWO_SIDED|95.0|-0.86|2.03|||Exact methods for risk difference|||Subchondral insufficiency fracture||2.03|-0.86|0.5632
70918562|NCT02528188|141328678|SUPERIORITY||Rate Difference|19.56||||0.0027|TWO_SIDED|95.0|6.78|32.35|||Poisson model for rate difference|||Rapidly Progressive OA Type 1 or 2||32.35|6.78|0.0027
70918563|NCT02528188|141328678|SUPERIORITY||Rate Difference|51.48|||<|0.0001|TWO_SIDED|95.0|34.47|68.5|||Poisson model for rate difference|||Rapidly Progressive OA Type 1 or 2||68.50|34.47|<0.0001
70918564|NCT02528188|141328678|SUPERIORITY||Rate Difference|17.58||||0.0047|TWO_SIDED|95.0|5.39|29.76|||Poisson model for rate difference|||Rapidly Progressive OA Type 1||29.76|5.39|0.0047
70918565|NCT02528188|141328678|SUPERIORITY||Rate Difference|38.22|||<|0.0001|TWO_SIDED|95.0|23.05|53.4|||Poisson model for rate difference|||Rapidly Progressive OA Type 1||53.40|23.05|<0.0001
70970802|NCT01157078|141447251|SUPERIORITY_OR_OTHER||LS mean|0.024|STANDARD_ERROR_OF_MEAN|0.0226||0.298|TWO_SIDED|95.0|-0.0209|0.068||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0680|-0.0209|0.298
70918566|NCT02528188|141328678|SUPERIORITY||Rate Difference|1.94||||0.3214|TWO_SIDED|95.0|-1.89|5.76|||Poisson model for rate difference|||Rapidly Progressive OA Type 2||5.76|-1.89|0.3214
70918567|NCT02528188|141328678|SUPERIORITY||Rate Difference|12.88||||0.0008|TWO_SIDED|95.0|5.36|20.39|||Poisson model for rate difference|||Rapidly Progressive OA Type 2||20.39|5.36|0.0008
70918568|NCT02528188|141328678|SUPERIORITY||Rate Difference|1.9||||0.5394|TWO_SIDED|95.0|-4.17|7.96|||Poisson model for rate difference|||Subchondral Insufficiency Fracture||7.96|-4.17|0.5394
70918569|NCT02528188|141328678|SUPERIORITY||Rate Difference|2.98||||0.3636|TWO_SIDED|95.0|-3.44|9.39|||Poisson model for rate difference|||Subchondral Insufficiency Fracture||9.39|-3.44|0.3636
70918570|NCT02528188|141328678|SUPERIORITY||Poisson model for rate difference|1.0|||||||||||||95% CI was not estimable since there were less number of participants with events.|Primary osteonecrosis||||
70918571|NCT02528188|141328678|SUPERIORITY||Rate Difference|1.0|||||||||||||95% CI was not estimable since there were less number of participants with events.|Primary osteonecrosis||||
70918572|NCT02528188|141328679|SUPERIORITY||Risk Difference (RD)|4.87||||0.0002|TWO_SIDED|95.0|2.43|7.74||The event of adjudicated primary osteonecrosis in the tanezumab 2.5 mg treatment group is not included in this analysis. Conclusions for this analysis do not change as the comparison to NSAID is already statistically significant in favor of NSAID.|Exact methods for risk difference|||||7.74|2.43|0.0002
70918573|NCT02528188|141328679|SUPERIORITY||Risk Difference (RD)|9.41|||<|0.0001|TWO_SIDED|95.0|6.73|12.52|||Exact methods for risk difference|||||12.52|6.73|<0.0001
70918574|NCT02528188|141328680|SUPERIORITY||Rate Difference|48.25|||<|0.0001|TWO_SIDED|95.0|26.76|69.74||The event of adjudicated primary osteonecrosis in the tanezumab 2.5 mg treatment group is not included in this analysis. Conclusions for this analysis do not change as the comparison to NSAID is already statistically significant in favor of NSAID.|Poisson model for rate difference|||||69.74|26.76|<0.0001
70970803|NCT01157078|141447251|SUPERIORITY_OR_OTHER||LS mean|1.6|STANDARD_ERROR_OF_MEAN|2.34||0.484|TWO_SIDED|95.0|-2.98|6.26||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||6.26|-2.98|0.484
70918575|NCT02528188|141328680|SUPERIORITY||Rate Difference|95.83|||<|0.0001|TWO_SIDED|95.0|70.25|121.42|||Poisson model for rate difference|||||121.42|70.25|<0.0001
70918576|NCT02528188|141328681|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.04||0.0979|TWO_SIDED|95.0|-0.15|0.01|||ANCOVA|||Change in medial JSW width at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.01|-0.15|0.0979
70918577|NCT02528188|141328681|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.24|-0.08|||ANCOVA|||Change in medial JSW at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||-0.08|-0.24|<0.0001
70918578|NCT02528188|141328681|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.1162|TWO_SIDED|95.0|-0.17|0.02|||ANCOVA|||Change in medial JSW at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.02|-0.17|0.1162
70918579|NCT02528188|141328681|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0128|TWO_SIDED|95.0|-0.22|-0.03|||ANCOVA|||Change in medial JSW at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||-0.03|-0.22|0.0128
70918580|NCT02528188|141328681|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.09||0.8885|TWO_SIDED|95.0|-0.17|0.2|||ANCOVA|||Change in lateral JSW at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.20|-0.17|0.8885
70918581|NCT02528188|141328681|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.1||0.6345|TWO_SIDED|95.0|-0.24|0.15|||ANCOVA|||Change in lateral JSW at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.15|-0.24|0.6345
70918582|NCT02528188|141328681|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.12||0.4406|TWO_SIDED|95.0|-0.32|0.14|||ANCOVA|||Change in lateral JSW at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.14|-0.32|0.4406
70918583|NCT02528188|141328681|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.12||0.7109|TWO_SIDED|95.0|-0.19|0.28|||ANCOVA|||Change in lateral JSW at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.28|-0.19|0.7109
70918584|NCT02528188|141328682|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.08||0.102|TWO_SIDED|95.0|-0.3|0.03|||ANCOVA|||Change at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.03|-0.30|0.1020
70918585|NCT02528188|141328682|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.08||0.023|TWO_SIDED|95.0|-0.35|-0.03|||ANCOVA|||Change at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||-0.03|-0.35|0.0230
70918586|NCT02528188|141328682|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.1||0.0645|TWO_SIDED|95.0|-0.37|0.01|||ANCOVA|||Change at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.01|-0.37|0.0645
70918587|NCT02528188|141328682|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.1||0.5005|TWO_SIDED|95.0|-0.26|0.13|||ANCOVA|||Change at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.13|-0.26|0.5005
70918588|NCT02528188|141328683|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0358|TWO_SIDED|95.0|1.04|3.29|||Regression, Logistic|||Decrease in medial JSW at Week 56: Logistic regression model included treatment, and baseline JSW as covariate.||3.29|1.04|0.0358
70970804|NCT03187769|141447252|SUPERIORITY||Least Squares Mean Difference|-1.87||||0.012|TWO_SIDED|95.0|-3.33|-0.41|||ANCOVA|||||-.41|-3.33|.012
70918589|NCT02528188|141328683|SUPERIORITY||Odds Ratio (OR)|2.37||||0.0021|TWO_SIDED|95.0|1.37|4.12|||Regression, Logistic|||Decrease in medial JSW at Week 56: Logistic regression model included treatment, and baseline JSW as covariate.||4.12|1.37|0.0021
70918590|NCT02528188|141328683|SUPERIORITY||Odds Ratio (OR)|2.01||||0.0301|TWO_SIDED|95.0|1.07|3.77|||Regression, Logistic|||Decrease in medial JSW at Week 80: Logistic regression model included treatment, and baseline JSW as covariate.||3.77|1.07|0.0301
70918591|NCT02528188|141328683|SUPERIORITY||Odds Ratio (OR)|2.65||||0.0016|TWO_SIDED|95.0|1.45|4.85|||Regression, Logistic|||Decrease in medial JSW at Week 80: Logistic regression model included treatment, and baseline JSW as covariate.||4.85|1.45|0.0016
70918592|NCT02528188|141328683|SUPERIORITY||Odds Ratio (OR)|0.55||||0.3002|TWO_SIDED|95.0|0.18|1.7|||Regression, Logistic|||Decrease in lateral JSW at Week 56: Logistic regression model included treatment, and baseline JSW as covariate.||1.70|0.18|0.3002
70918593|NCT02528188|141328683|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8997|TWO_SIDED|95.0|0.39|2.89|||Regression, Logistic|||Decrease in lateral JSW at Week 56: Logistic regression model included treatment, and baseline JSW as covariate.||2.89|0.39|0.8997
70918594|NCT02528188|141328683|SUPERIORITY||Odds Ratio (OR)|1.48||||0.4559|TWO_SIDED|95.0|0.53|4.18|||Regression, Logistic|||Decrease in lateral JSW at Week 80: Logistic regression model included treatment, and baseline JSW as covariate.||4.18|0.53|0.4559
70918595|NCT02528188|141328683|SUPERIORITY||Odds Ratio (OR)|0.71||||0.5996|TWO_SIDED|95.0|0.2|2.54|||Regression, Logistic|||Decrease in lateral JSW at Week 80: Logistic regression model included treatment, and baseline JSW as covariate.||2.54|0.20|0.5996
70918596|NCT02528188|141328684|SUPERIORITY||Odds Ratio (OR)|3.37||||0.0714|TWO_SIDED|95.0|0.9|12.65|||Regression, Logistic|||Decrease at Week 56: Logistic regression model included treatment, and baseline JSW as covariate||12.65|0.90|0.0714
70918597|NCT02528188|141328684|SUPERIORITY||Odds Ratio (OR)|3.42||||0.0681|TWO_SIDED|95.0|0.91|12.84|||Regression, Logistic|||Decrease at Week 56: Logistic regression model included treatment, and baseline JSW as covariate||12.84|0.91|0.0681
70918598|NCT02528188|141328684|SUPERIORITY||Odds Ratio (OR)|3.12||||0.0967|TWO_SIDED|95.0|0.81|11.95|||Regression, Logistic|||Decrease at Week 80: Logistic regression model included treatment, and baseline JSW as covariate||11.95|0.81|0.0967
70918599|NCT02528188|141328684|SUPERIORITY||Odds Ratio (OR)|3.11||||0.0976|TWO_SIDED|95.0|0.81|11.9|||Regression, Logistic|||Decrease at Week 80: Logistic regression model included treatment, and baseline JSW as covariate||11.90|0.81|0.0976
70918600|NCT02528188|141328685|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.2212|TWO_SIDED|95.0|-0.27|0.06|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.06|-0.27|0.2212
70918601|NCT02528188|141328685|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.08||0.4557|TWO_SIDED|95.0|-0.1|0.23|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.23|-0.10|0.4557
70918602|NCT02528188|141328685|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.09||0.0029|TWO_SIDED|95.0|-0.45|-0.09|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.09|-0.45|0.0029
70918603|NCT02528188|141328685|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.09||0.0005|TWO_SIDED|95.0|-0.5|-0.14|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.14|-0.50|0.0005
70918604|NCT02528188|141328685|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.09||0.1273|TWO_SIDED|95.0|-0.33|0.04|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.04|-0.33|0.1273
70918605|NCT02528188|141328685|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.57|-0.2|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.20|-0.57|<0.0001
70918606|NCT02528188|141328685|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.13||0.6349|TWO_SIDED|95.0|-0.31|0.19|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.19|-0.31|0.6349
70970805|NCT00879229|141447271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.0|STANDARD_ERROR_OF_MEAN|67.0||0.696|TWO_SIDED|95.0|-54.0|17.0||This is an exact Wilcoxon rank sum test p-value for testing equality of ambrisentan and placebo distributions.|Wilcoxon (Mann-Whitney)|||||17|-54|0.696
70970806|NCT01097746|141447282|SUPERIORITY||Hazard Ratio (HR)|1.71||||0.33|TWO_SIDED|95.0|0.58|4.98|||t-test, 2 sided|||Participants for optimal ≤ 1 cm||4.98|0.58|0.33
70918607|NCT02528188|141328685|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.13||0.1339|TWO_SIDED|95.0|-0.44|0.06|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.06|-0.44|0.1339
70918608|NCT02528188|141328685|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.13||0.6237|TWO_SIDED|95.0|-0.33|0.2|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.20|-0.33|0.6237
70918609|NCT02528188|141328685|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.4224|TWO_SIDED|95.0|-0.37|0.16|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.16|-0.37|0.4224
70918610|NCT02528188|141328685|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7526|TWO_SIDED|95.0|-0.31|0.22|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.22|-0.31|0.7526
70918611|NCT02528188|141328685|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.13||0.7328|TWO_SIDED|95.0|-0.31|0.22|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.22|-0.31|0.7328
70918612|NCT02528188|141328685|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.13||0.5888|TWO_SIDED|95.0|-0.33|0.19|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.19|-0.33|0.5888
70918613|NCT02528188|141328685|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.14||0.9345|TWO_SIDED|95.0|-0.28|0.26|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.26|-0.28|0.9345
71093227|NCT00088153|141693737|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||After controlling for baseline age and weight changes|t-test, 2 sided|We also used a mixed model analysis of variance (PROC MIXED), to analyze longitudinal data.||Power analysis: We have previously demonstrated that normal female adolescents gain bone density at the rate of 0.039 +/- 0.0507 per year. The pooled SD in that study was 0.046. Based on these data, with a sample size of 110 girls with anorexia nervosa (AN), half of whom are randomized to receive estrogen and half placebo (with a 10% drop-out rate), there will be an 80% chance that we will detect an increase in bone density to 75% of normal in the girls who receive estrogen.||||<0.05
70918614|NCT02528188|141328685|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.14||0.8782|TWO_SIDED|95.0|-0.29|0.25|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.25|-0.29|0.8782
70918615|NCT02528188|141328685|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.7076|TWO_SIDED|95.0|-0.22|0.32|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.32|-0.22|0.7076
70918616|NCT02528188|141328687|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.08||0.015|TWO_SIDED|95.0|-0.37|-0.04|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.04|-0.37|0.0150
70918617|NCT02528188|141328687|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.08||0.3286|TWO_SIDED|95.0|-0.25|0.08|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.08|-0.25|0.3286
70918618|NCT02528188|141328687|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.09||0.0004|TWO_SIDED|95.0|-0.5|-0.15|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.15|-0.50|0.0004
70970807|NCT01097746|141447282|SUPERIORITY||Hazard Ratio (HR)|3.75||||0.04|TWO_SIDED|95.0|1.05|13.34|||t-test, 2 sided|||suboptimal \> 1 cm||13.34|1.05|0.04
70918619|NCT02528188|141328687|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.09||0.0001|TWO_SIDED|95.0|-0.53|-0.17|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.17|-0.53|0.0001
70918620|NCT02528188|141328687|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.09||0.0517|TWO_SIDED|95.0|-0.37|0.0|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.00|-0.37|0.0517
70918621|NCT02528188|141328687|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.61|-0.23|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.23|-0.61|<0.0001
70918622|NCT02528188|141328687|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.13||0.3621|TWO_SIDED|95.0|-0.37|0.13|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.13|-0.37|0.3621
70918623|NCT02528188|141328687|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.13||0.0832|TWO_SIDED|95.0|-0.47|0.03|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.03|-0.47|0.0832
70918624|NCT02528188|141328687|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.4072|TWO_SIDED|95.0|-0.38|0.15|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.15|-0.38|0.4072
70918625|NCT02528188|141328687|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.13||0.3404|TWO_SIDED|95.0|-0.39|0.13|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.13|-0.39|0.3404
70918626|NCT02528188|141328687|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.6344|TWO_SIDED|95.0|-0.34|0.2|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.20|-0.34|0.6344
70918627|NCT02528188|141328687|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.5756|TWO_SIDED|95.0|-0.35|0.19|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.19|-0.35|0.5756
70918628|NCT02528188|141328687|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.14||0.4394|TWO_SIDED|95.0|-0.38|0.16|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.16|-0.38|0.4394
70918629|NCT02528188|141328687|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7747|TWO_SIDED|95.0|-0.31|0.23|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.23|-0.31|0.7747
71093228|NCT00088153|141693738|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||t-test, 2 sided|||The null hypothesis was that there would be no differences between the groups for changes in P1NP levels over time||||>0.05
71093229|NCT00088153|141693739|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||The p value was adjusted for age and weight changes|t-test, 2 sided|||The null hypothesis was that the groups would not differ for changes in spine bone density z-scores over the study duration||||<0.05
71093230|NCT04426656|141693742|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||The comparison was made using the outcome variable measured at Week 12.||||0.85
71093231|NCT04426656|141693743|SUPERIORITY|||||||0.72|||||||Chi-squared|||||||0.72
71093232|NCT04426656|141693744|SUPERIORITY|||||||0.318|||||||Fisher Exact|||||||0.318
71093233|NCT04426656|141693745|SUPERIORITY|||||||0.527|||||||Fisher Exact|||||||0.527
71093234|NCT04426656|141693746|SUPERIORITY|||||||0.928|||||||Fisher Exact|||||||0.928
71093235|NCT04426656|141693747|SUPERIORITY|||||||0.678|||||||Fisher Exact|||||||0.678
71093236|NCT04426656|141693748|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||The comparison test was made using the outcome variable measured at Week 12.||||0.26
71093237|NCT04426656|141693749|SUPERIORITY|||||||0.08|||||||Fisher Exact|||The comparison was made using data measured at Week 12.||||0.08
70918630|NCT02528188|141328687|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.14||0.7305|TWO_SIDED|95.0|-0.32|0.22|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.22|-0.32|0.7305
70918631|NCT02528188|141328687|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.733|TWO_SIDED|95.0|-0.22|0.32|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.32|-0.22|0.7330
70918632|NCT02528188|141328689|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.03||0.2159|TWO_SIDED|95.0|-0.1|0.02|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.02|-0.10|0.2159
70918633|NCT02528188|141328689|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.03||0.2049|TWO_SIDED|95.0|-0.1|0.02|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.02|-0.10|0.2049
70918634|NCT02528188|141328689|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.03||0.0002|TWO_SIDED|95.0|-0.19|-0.06|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||-0.06|-0.19|0.0002
71153951|NCT00488683|141800066|SUPERIORITY_OR_OTHER||R-square|0.21||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||
70918635|NCT02528188|141328689|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|-0.21|-0.08|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||-0.08|-0.21|<0.0001
70970808|NCT00631371|141447306|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.8|TWO_SIDED|95.0|0.9|1.3|||Log Rank|||P value was based on 1-sided stratified log-rank test (stratification factors: prior nephrectomy \[yes/no\] and Memorial Sloan Kettering Cancer Center \[MSKCC\] risk factors \[good/intermediate/poor\] at time of randomization). The hazard ratio and corresponding 95 percent (%) confidence interval (CI) from the stratified cox proportional hazard model were also presented.||1.3|0.9|0.8
70970809|NCT00631371|141447307|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.9|TWO_SIDED|95.0|1.0|1.4|||Log Rank|||P-value was based on 1-sided stratified log-rank test (stratification factors: prior nephrectomy \[yes/no\] and MSKCC risk factors \[good/intermediate/poor\] at time of randomization). The hazard ratio and corresponding 95% CI from the stratified cox proportional hazard model were also presented.||1.4|1.0|0.9
70970810|NCT00631371|141447308|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|0.8|1.3|||Cochran-Mantel-Haenszel|||P-value (2-sided), risk ratio and associated 95% CI were based on Cochran-Mantel-Haenszel test stratified by prior nephrectomy and MSKCC risk group as randomized.||1.3|0.8|1.0
70970811|NCT00631371|141447309|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.6|TWO_SIDED|95.0|0.9|1.3|||Log Rank|||P value was based on 1-sided stratified log-rank test (stratification factors: prior nephrectomy \[yes/no\] and MSKCC risk factors \[good/intermediate/poor\] at time of randomization). The hazard ratio and corresponding 95% CI from the stratified cox proportional hazard model were also presented.||1.3|0.9|0.6
71093238|NCT04426656|141693750|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||The comparison was made using data measured at Week 12.||||0.03
71093239|NCT04426656|141693751|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||This comparison was made using data at Week 12.||||0.58
71093240|NCT04426656|141693752|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||The comparison was made using data measured at Week 12.||||0.85
71093241|NCT04357795|141693754|OTHER|Single group analysis|||||<|0.0001|||||||Paired t-test|||||||<0.0001
71093242|NCT04357795|141693755|OTHER|Single group analysis|||||<|0.0001|||||||Paired t-test|||||||<0.0001
71093243|NCT04357795|141693756|OTHER|Single group analysis|||||<|0.0001|||||||Paired t-test|||||||<0.0001
71093244|NCT04357795|141693757|OTHER|Single group analysis|||||<|0.0001|||||||Paired t-test|||||||<0.0001
71093245|NCT04357795|141693758|OTHER|Single group analysis||||||0.0323|||||||Paired t-test|OD- Right eye p value||||||0.0323
71093246|NCT04357795|141693758|OTHER|Single group analysis||||||0.3447||||||OS: P-Value|Paired t-test|||||||0.3447
71093247|NCT04357795|141693759|OTHER|Single group analysis|||||<|0.0001|||||||Paired t-test|||||||<0.0001
71093248|NCT04357795|141693760|OTHER|Single group analysis||||||0.0029|||||||Paired t-test|||||||0.0029
71153952|NCT00488683|141800066|SUPERIORITY_OR_OTHER||R-square|0.39||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||
70970812|NCT03962439|141447312|OTHER|Null-hypothesis significance testing|F-value|1.61||||0.211|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|ANCOVA|Adjusted for baseline age, sex, and education.||Repeated measures ANCOVA testing whether change in episodic memory from baseline to 16 weeks interacted with condition (Time x Condition).||||.211
70970813|NCT03962439|141447314|OTHER|Null hypothesis significance testing|F-value|1.66||||0.203|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|ANCOVA|Adjusted for baseline age, sex, and education.||Repeated measures ANCOVA testing whether change in speed of processing from baseline to 16 weeks interacted with condition (Time x Condition).||||.203
70970814|NCT03962439|141447316|OTHER|Null hypothesis significance testing|F-value|0.28||||0.76|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|ANCOVA|Adjusted for baseline age, sex, and education.||Repeated measures ANCOVA testing whether change in reasoning from baseline to week 16 interacted with condition (Time x Condition).||||.760
70970815|NCT00812214|141447333|SUPERIORITY|For the purpose of the power calculation, it was assumed that the difference in total sleep time between the treatment groups is 40 minutes, with a standard deviation of 60. The pilot nature of the study allowed the use of alpha = 0.05 and beta = 0.2, with two-sided comparison, generating a required sample size of 37 subjects per arm.||||||0.33|||||||t-test, 2 sided|two-tailed student's t-test for independent samples||The null hypothesis is that there is no difference in the 6 week average total sleep time||||0.33
70970816|NCT00812214|141447334|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||The null hypothesis is that there is no difference between the eszopiclone and placebo groups in the number of awakenings/night at 6 weeks.||||0.03
70970817|NCT00812214|141447336|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||Null hypothesis is that there is no difference between Eszopiclone and placebo groups in sleep quality averaged over 6 weeks of treatment.||||0.1
70970818|NCT00812214|141447336|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||Null hypothesis is that there is no difference between Eszopiclone and placebo groups in daytime alertness averaged over 6 weeks of treatment.||||0.29
70970819|NCT00812214|141447336|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||Null hypothesis is that there is no difference between Eszopiclone and placebo groups in daytime fatigue averaged over 6 weeks of treatment.||||0.05
70970820|NCT00812214|141447336|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||Null hypothesis is that there is no difference between Eszopiclone and placebo groups in daytime functioning averaged over 6 weeks of treatment.||||0.76
70970821|NCT00812214|141447338|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||The null hypothesis is that there is no difference in average days/week between eszopiclone and placebo groups at 6 weeks.||||0.89
70970822|NCT00812214|141447339|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|||The null hypothesis is that there is no difference in headache duration between eszopiclone and placebo groups at 6 weeks.||||0.98
70970823|NCT00812214|141447340|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||The null hypothesis is that there is no difference in headache intensity between eszopiclone and placebo groups at 6 weeks.||||0.82
70970824|NCT01192022|141447345|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.87|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|2.55|9.29||Logistic regression model with treatment and pooled center as factors.|Regression, Logistic|||||9.29|2.55|<0.001
70970825|NCT00129766|141447349|NON_INFERIORITY_OR_EQUIVALENCE|Confidence interval and relative risk adjusted for the stratification factor of presence or absence of CLD of prematurity as specified on the CRF.|Risk Ratio (RR)|0.74|||||TWO_SIDED|95.0|0.503|1.083|||t-test, 2 sided||Relative risk was calculated as (Pn/Ps) where Pn is the proportion of patients with RSV hospitalization in the motavizumab group and Ps is the proportion of patients with RSV hospitalization in the palivizumab group.|ITT population||1.083|0.503|
70970826|NCT00129766|141447358|NON_INFERIORITY_OR_EQUIVALENCE|A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.||||||0.11||95.0||||Test stratified by presence or absence of CLD of prematurity specified on the CRF|Cochran-Mantel-Haenszel|||||||0.110
70970827|NCT00129766|141447359|NON_INFERIORITY_OR_EQUIVALENCE|A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.||||||0.005||95.0||||No adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The CMH test was stratified by presence or absence of CLD of prematurity as specified on the CRF||||||0.005
70970828|NCT00129766|141447360|NON_INFERIORITY_OR_EQUIVALENCE|A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.||||||0.476||95.0|||||Van Eleteren test|Test stratified by presence or absence of CLD of prematurity specified on the CRF||P-value is for overall incidence||||0.476
70970829|NCT00129766|141447361|NON_INFERIORITY_OR_EQUIVALENCE|A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.||||||0.493||95.0||||Test stratified by presence or absence of CLD of prematurity specified on the CRF|Van Eleteren test|||||||0.493
70970830|NCT00129766|141447362|NON_INFERIORITY_OR_EQUIVALENCE|A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.||||||0.652||95.0||||Test stratified by presence or absence of CLD of prematurity specified on the CRF|Van Eleteren test|||||||0.652
70970831|NCT01515787|141447392|NON_INFERIORITY|Disease recurrence or death in order to have 85% power to reject the null hypothesis. Noninferiority of the intervention could be claimed if the upper limit of the two-sided 90.2% confidence interval of the hazard ratio for disease recurrence or death did not exceed the 1.29 noninferiority margin.|Hazard Ratio (HR)|0.92||||0.005|TWO_SIDED|90.2|0.74|1.14|||kaplan meier|||||1.14|0.74|0.005
70970832|NCT01515787|141447394|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.74|1.44||||||||1.44|0.74|
70970833|NCT01515787|141447396|SUPERIORITY||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.44|3.16||||||||3.16|0.44|
70970834|NCT03776175|141447414|SUPERIORITY||Difference in LS mean|-44.52||||0|TWO_SIDED|90.0|-54.97|-31.65|||ANCOVA||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 90% CI was calculated on difference in least square (LS) mean between groups||-31.65|-54.97|0.0000
71093249|NCT05168800|141693787|SUPERIORITY|||||||0.99||||||To achieve a group-wise 95% confidence for the primary outcome, each of the three tests were evaluated with acceptance based on a 98.4% confidence interval, or greater than 2.15 standard deviations of the mean for the superiority analyses.|Groupwise binomial comparison|||||||0.99
70970835|NCT03776175|141447414|SUPERIORITY||Difference in LS Mean|-35.4||||0.0007|TWO_SIDED|90.0|-47.4|-20.68|||ANCOVA||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 90% CI was calculated on difference LS mean between groups.||-20.68|-47.40|0.0007
70970836|NCT03776175|141447414|SUPERIORITY||Difference in LS Mean|-44.64||||0|TWO_SIDED|90.0|-54.8|-32.19|||ANCOVA||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 90% CI was calculated on difference in LS mean between groups.||-32.19|-54.80|0.0000
70970837|NCT03776175|141447414|SUPERIORITY||Difference in LS Mean|-0.21||||0.9836|TWO_SIDED|90.0|-15.66|18.08|||ANCOVA||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 90% CI was calculated on difference in LS mean between groups.||18.08|-15.66|0.9836
70970838|NCT03776175|141447414|SUPERIORITY||Difference in LS Mean|-14.3||||0.1233|TWO_SIDED|90.0|-27.32|1.06|||ANCOVA||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 90% CI was calculated on difference in LS mean between groups.||1.06|-27.32|0.1233
70970839|NCT03776175|141447414|SUPERIORITY||Difference in LS Mean|-0.21|||||TWO_SIDED|50.0|-6.82|6.87|||||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 50% CI was calculated on difference in LS mean between groups.||6.87|-6.82|
70970840|NCT03776175|141447414|SUPERIORITY||Difference in LS Mean|-14.3|||||TWO_SIDED|50.0|-19.86|-8.35|||||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 50% CI was calculated on difference in LS mean between groups.||-8.35|-19.86|
70970841|NCT04852848|141447440|EQUIVALENCE|In our original power calculation, we expected to randomly assign 200 individuals to the Connect2Test (n = 100) and control conditions (n = 100). Power calculations were conducted using G\*Power assuming a two-tailed test with alpha = .05, power = .80, and an estimated COVID-19 testing rate in the Connect2Test condition of 20%. With these assumptions, the minimum detectable effect size (odds ratio) is 2.46, which corresponds to a moderate Cohen's d (0.49).|Odds Ratio (OR)|1.18||||0.6298|TWO_SIDED|95.0|0.61|2.27|||Chi-squared||The control condition was the reference category (Connect2Test intervention = 1, Control = 0).|||2.27|0.61|.6298
70970842|NCT05525533|141447497|SUPERIORITY||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-1.87|2.24|||Regression, Linear|||||2.24|-1.87|
70970843|NCT05525533|141447497|SUPERIORITY||Mean Difference (Final Values)|1.55|||||TWO_SIDED|95.0|-0.73|3.82|||Regression, Linear|||||3.82|-0.73|
70970844|NCT05525533|141447499|SUPERIORITY||Mean Difference (Final Values)|7.58|||||TWO_SIDED|95.0|-2.92|18.0|||Regression, Linear|||||18|-2.92|
70970845|NCT05525533|141447499|SUPERIORITY||Mean Difference (Final Values)|16.0|||||TWO_SIDED|95.0|0.64|31.0|||Regression, Linear|||||31|0.64|
70970846|NCT05525533|141447501|SUPERIORITY||Mean Difference (Final Values)|47.0|||||TWO_SIDED|95.0|-18.0|113.0|||Regression, Linear|||||113|-18|
70970847|NCT05525533|141447501|SUPERIORITY||Mean Difference (Final Values)|113.0|||||TWO_SIDED|95.0|38.0|189.0|||Regression, Linear|||||189|38|
70970848|NCT05525533|141447502|SUPERIORITY||Mean Difference (Final Values)|3.63|||||TWO_SIDED|95.0|-1.37|8.63|||Regression, Linear|||||8.63|-1.37|
70970849|NCT05525533|141447502|SUPERIORITY||Mean Difference (Final Values)|1.5|||||TWO_SIDED|95.0|-1.5|4.5|||Regression, Linear|||||4.50|-1.50|
70970850|NCT05525533|141447503|SUPERIORITY||Mean Difference (Final Values)|1.32|||||TWO_SIDED|95.0|-0.36|7.3|||Regression, Linear|||||7.30|-0.36|
70970851|NCT05525533|141447503|SUPERIORITY||Mean Difference (Final Values)|3.38|||||TWO_SIDED|95.0|-0.54|7.3|||Regression, Linear|||||7.30|-0.54|
70970852|NCT05525533|141447504|SUPERIORITY||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-3.38|3.72|||Regression, Linear|||||3.72|-3.38|
70970853|NCT05525533|141447504|SUPERIORITY||Mean Difference (Final Values)|7.57|||||TWO_SIDED|95.0|0.42|15.0|||Regression, Linear|||||15|0.42|
70970854|NCT05525533|141447505|SUPERIORITY||Mean Difference (Final Values)|2.46|||||TWO_SIDED|95.0|-0.11|5.02|||Regression, Linear|||||5.02|-0.11|
70970855|NCT05525533|141447505|SUPERIORITY||Mean Difference (Final Values)|3.29|||||TWO_SIDED|95.0|0.33|6.25|||Regression, Linear|||||6.25|0.33|
70970856|NCT02915523|141447510|OTHER||Hazard Ratio (HR)|0.899|||||TWO_SIDED|95.0|0.581|1.393|||||Stratified HR estimated from a stratified univeriate Cox proportional hazards model. Avelumab + placebo was the reference treatment group.|||1.393|0.581|
70970857|NCT00930761|141447524|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.22||||0.06||95.0|0.99|1.51|||Chi-squared|||Null hypothesis: Music therapy does not increase the rate of maternal breastfeeding. Sample size: considering 75% as the expected rate at the time of the infant hospital discharge and an absolute difference of 30% between groups, 95% confidence level (5% alpha error) and 80% power (20% beta error), 94 subjects would need to be enrolled (47 in each study arm). Expecting a 7.5% loss after randomization, 101 was the total number of subjects considered necessary to conduct the study.||1.51|0.99|0.06
70970858|NCT00930761|141447525|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.21||||0.13||95.0|0.73|5.66|||Chi-squared|||||5.66|0.73|0.13
71031797|NCT02728102|141572287|SUPERIORITY|||||||0.1757||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||A pairwise analysis of proportion of participants achieving CR among the subset of participants who are not in CR at the time of randomization between lenalidomide/GM-CSF arm and lenalidomide alone arm is conducted at 1 year post transplant.||||0.1757
70970859|NCT00930761|141447526|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.26||||0.03||95.0|1.01|1.57|||Chi-squared|||Null hypothesis: Music therapy does not increase the rate of maternal breastfeeding. Sample size: considering 75% as the expected rate at the time of the first follow-up visit and an absolute difference of 30% between groups, 95% confidence level (5% alpha error) and 80% power (20% beta error), 94 subjects would need to be enrolled (47 in each study arm). Expecting a 7.5% loss after randomization, 101 was the total number of subjects considered necessary to conduct the study.||1.57|1.01|0.03
70970860|NCT00930761|141447527|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.28||||0.09||95.0|0.95|1.71|||Chi-squared|||||1.71|0.95|0.09
70970861|NCT04677959|141447555|OTHER||Odds Ratio (OR)|1.35|||||TWO_SIDED|95.0||||||||The 95% credible intervals of the odds ratio from the posterior distributions were calculated and presented.||||
70970862|NCT01970995|141447574|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|13.49|||<|0.001|TWO_SIDED|95.0|10.96|16.6||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the biomarker of exposure (BoExp) was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||16.60|10.96|<.001
70970863|NCT01970995|141447575|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|50.67|||<|0.001|TWO_SIDED|95.0|44.88|57.2||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on 3-HPMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||57.20|44.88|<.001
70970864|NCT01970995|141447576|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|10.97|||<|0.001|TWO_SIDED|95.0|9.26|12.99||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on S-PMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||12.99|9.26|<.001
70970865|NCT01970995|141447577|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|44.94|||<|0.001|TWO_SIDED|95.0|42.11|47.97||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on COHb levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||47.97|42.11|<.001
70970866|NCT01970995|141447578|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|23.25|||<|0.001|TWO_SIDED|95.0|17.38|31.11||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on Total NNAL levels with product, sex, cigarette consumption, and baseline value as covariates|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 90 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 90 for mTHS 2.2 and mCC respectively."||31.11|17.38|<.001
70970867|NCT04442230|141447587|SUPERIORITY|||||||0.6602|||||||Fisher Exact|||The p-values from significance tests were obtained at a one-sided significance level of 0.025.||||0.6602
70970868|NCT02599961|141447591|SUPERIORITY||LS Mean|-82.73|STANDARD_ERROR_OF_MEAN|11.363|<|0.0001|TWO_SIDED|95.0|-105.0|-60.46||From the GEE model which includes the reduction from baseline for each visit period as the response variable, baseline as covariates, visit period as a factor, identity link function and exchangeable within subject working correlation matrix.|generalized estimating equation (GEE)|||Month 0-3||-60.46|-105.00|< 0.0001
70970869|NCT02599961|141447591|SUPERIORITY||LS mean|-54.91|STANDARD_ERROR_OF_MEAN|16.097||0.0006|TWO_SIDED|95.0|-86.46|-23.36||From the GEE model which includes the reduction from baseline for each visit period as the response variable, baseline as covariates, visit period as a factor, identity link function and exchangeable within subject working correlation matrix.|GEE model|||Month 4-6||-23.36|-86.46|0.0006
71153953|NCT00488683|141800066|SUPERIORITY_OR_OTHER||R-square|0.33||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||
71153954|NCT00488683|141800067|SUPERIORITY_OR_OTHER||R-square|0.24||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup A||||
70970870|NCT02599961|141447591|SUPERIORITY||LS Mean|-52.53|STANDARD_ERROR_OF_MEAN|16.882||0.0019|TWO_SIDED|95.0|-85.62|-19.45||From the GEE model which includes the reduction from baseline for each visit period as the response variable, baseline as covariates, visit period as a factor, identity link function and exchangeable within subject working correlation matrix.|GEE model|||Month 7-9||-19.45|-85.62|0.0019
70970871|NCT02599961|141447591|SUPERIORITY||LS Mean|-82.65|STANDARD_ERROR_OF_MEAN|15.55|<|0.0001|TWO_SIDED|95.0|-113.13|-52.17||From the GEE model which includes the reduction from baseline for each visit period as the response variable, baseline as covariates, visit period as a factor, identity link function and exchangeable within subject working correlation matrix.|GEE model|||Month 10-12||-52.17|-113.13|< 0.0001
70970872|NCT03341962|141447601|SUPERIORITY||Odds Ratio (OR)|1.0188||||0.5836|TWO_SIDED||||||Cochran-Mantel-Haenszel|1-sided exact test adjusted for stratification factors (prior use of any biologics and concurrent use of corticosteroids), α=0.097||||||0.5836
70970873|NCT00385255|141447668|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% confidence interval (CI) for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentages of subjects with anti-D antibody concentrations ≥ 0.1 IU/mL, being ≥ - 10%.|Difference in percentage|1.06|||||TWO_SIDED|95.0|-1.36|3.56||||||Difference in seroprotection rates against diphteria toxoid: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of seroprotection rates for anti-D antibody, one month post-Boostrix® vaccination.||3.56|-1.36|
70970874|NCT00385255|141447668|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+ Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-T antibody concentrations ≥ 0.1 IU/mL, being ≥ - 10%.|Difference in percentage|-1.67|||||TWO_SIDED|95.0|-2.96|-0.74||||||Difference in seroprotection rates against tetanus toxoid: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of seroprotection rates for anti-T antibody, one month post-Boostrix® vaccination.||-0.74|-2.96|
70970875|NCT00385255|141447669|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-T antibody concentrations ≥ 1.0 IU/mL, being ≥ - 10%.|Difference in percentage|1.4|||||TWO_SIDED|95.0|-0.77|3.68||||||Difference in seropositivity rates against tetanus toxoid: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of seropositivity rates for anti-T antibody, one month post-Boostrix® vaccination.||3.68|-0.77|
70970876|NCT00385255|141447670|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for GMC ratios of antibodies against the pertussis toxoid (PT) antigens between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group) being ≥ 0.67.|Adjusted GMC ratio|0.74|||||TWO_SIDED|95.0|0.67|0.82|||ANCOVA|||Difference in adjusted GMC ratios for anti-PT antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of geometric mean concentrations (GMCs) for anti-PT antibody, one month post-Boostrix® vaccination.||0.82|0.67|
71093250|NCT05168800|141693787|SUPERIORITY|||||||0.98||||||To achieve a group-wise 95% confidence for the primary outcome, each of the three tests were evaluated with acceptance based on a 98.4% confidence interval, or greater than 2.15 standard deviations of the mean for the superiority analyses.|Groupwise binomial comparison|||||||0.98
70970877|NCT00385255|141447670|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for GMC ratios of antibodies against the filamentous hemagglutinin (FHA) antigens between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group) being ≥ 0.67.|Adjusted GMC ratio|0.71|||||TWO_SIDED|95.0|0.64|0.79|||ANCOVA|||Difference in adjusted GMC ratio for anti-FHA antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of geometric mean concentrations (GMCs) for anti-FHA antibody, one month post-Boostrix® vaccination.||0.79|0.64|
70970878|NCT00385255|141447670|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for GMC ratios of antibodies against the pertactin (PRN) antigens between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group) being ≥ 0.67.|Adjusted GMC ratio|0.7|||||TWO_SIDED|95.0|0.6|0.81|||ANCOVA|||Difference in adjusted GMC ratio for anti-PRN antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of geometric mean concentrations (GMCs) for anti-PRN antibody, one month post-Boostrix® vaccination.||0.81|0.60|
70970879|NCT00385255|141447671|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-H1N1 antibody titers ≥ 1:40 being ≥ -10%.|Difference in percentage|-1.17|||||TWO_SIDED|95.0|-3.58|1.23||||||Difference in percentage of subjects with anti-H1N1 antibody titers ≥ 1:40: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-H1N1 antibody titers ≥ 1:40, one month post-Fluarix® vaccination.||1.23|-3.58|
71153955|NCT00488683|141800067|SUPERIORITY_OR_OTHER||R-square|0.19||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup A||||
71153956|NCT00488683|141800067|SUPERIORITY_OR_OTHER||R-square|0.52||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup C||||
70970880|NCT00385255|141447671|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-H3N2 antibody titers ≥ 1:40 being ≥ -10%.|Difference in percentage|-0.61|||||TWO_SIDED|95.0|-2.22|0.96||||||Difference in percentage of subjects with anti-H3N2 antibody titers ≥ 1:40: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-H3N2 antibody titers ≥ 1:40, one month post-Fluarix® vaccination.||0.96|-2.22|
70970881|NCT00385255|141447671|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-B antibody titers ≥ 1:40 being ≥ -10%.|Difference in percentage|-0.55|||||TWO_SIDED|95.0|-2.52|1.42||||||Difference in percentage of subjects with anti-B antibody titers ≥ 1:40: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-B antibody titers ≥ 1:40, one month post-Fluarix® vaccination.||1.42|-2.52|
70970882|NCT00385255|141447672|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with ≥ 4-fold increase in anti-H1N1 antibody titers (seroconversion) being ≥ -10%.|Difference in seroconversion rate|2.37|||||TWO_SIDED|95.0|-2.84|7.58||||||Difference in seroconversion rates for anti-H1N1 antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of seroconversion rates for anti-H1N1 antibody, one month post-Fluarix® vaccination.||7.58|-2.84|
70970883|NCT00385255|141447672|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with ≥ 4-fold increase in anti-H3N2 antibody titers (seroconversion) being ≥ -10%.|Difference in seroconversion rate|5.58|||||TWO_SIDED|95.0|1.1|10.07||||||Difference in seroconversion rates for anti-H3N2 antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of seroconversion rates for anti-H3N2 antibody, one month post-Fluarix® vaccination.||10.07|1.10|
70970884|NCT00385255|141447672|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with ≥ 4-fold increase anti-B antibody titers (seroconversion) being ≥ -10%.|Difference in seroconversion rate|2.15|||||TWO_SIDED|95.0|-2.9|7.2||||||Difference in seroconversion rates for anti-B antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of seroconversion rates for anti-B antibody, one month post-Fluarix® vaccination.||7.20|-2.90|
70970885|NCT02079987|141447699|SUPERIORITY|||||||0.49|||||||difference-in-difference analysis|A propensity weighted difference-in-difference approach was taken to account for imbalances in assignment and loss to follow-up.||||||0.49
70970886|NCT02079987|141447700|SUPERIORITY|||||||0.23|||||||difference-in-difference analysis|A propensity weighted difference-in-difference approach was taken to account for imbalances in assignment and loss to follow-up.||||||0.23
70970887|NCT02079987|141447701|SUPERIORITY|||||||0.25||||||A propensity weighted difference-in-difference approach was taken to account for imbalances in assignment and loss to follow-up.|difference-in-difference analysis|||||||0.25
70970888|NCT02079987|141447702|SUPERIORITY|||||||0.03|||||||Chi-squared|||||||0.03
70970889|NCT02079987|141447703|SUPERIORITY|||||||0.57|||||||Chi-squared|||||||0.57
70970890|NCT02079987|141447704|SUPERIORITY|||||||0.87|||||||Chi-squared|||||||0.87
70970891|NCT01445951|141447706|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with 0.4 margin|Mean Difference (Net)|0.19|STANDARD_ERROR_OF_MEAN|0.086|||TWO_SIDED|95.0|0.02|0.36||||||MMRM (mixed model repeated measures) model with auto-regression (1): HbA1c = Baseline HbA1c + region + basal insulin stratum + visit + treatment + (visit\*treatment)||0.36|0.02|
70970892|NCT01445951|141447707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.016|||TWO_SIDED|95.0|-0.02|0.04|||||Mixed Model Repeated Measure (MMRM): FEV1 = Baseline FEV1 + Age + Gender + Race + Baseline Height + Visit + Treatment + (Visit\*Treatment)|||0.04|-0.02|
70970893|NCT01445951|141447708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-35.42|STANDARD_ERROR_OF_MEAN|10.622|||TWO_SIDED|95.0|-56.25|-14.59|||||MMRM: FPG = Baseline FPG + Region + Basal insulin stratum + Visit + Treatment + (Visit\*Treatment)|||-14.59|-56.25|
70970894|NCT01445951|141447711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32|STANDARD_ERROR_OF_MEAN|0.512||0.0102|TWO_SIDED|95.0|-2.33|-0.31|||ANCOVA|ANCOVA: Weight change from baseline = Baseline weight + Change from baseline in HbA1c + Region + Basal insulin stratum + Treatment|ANCOVA: Weight change from baseline = Baseline weight + Change from baseline in HbA1c + Region + Basal insulin stratum + Treatment|||-0.31|-2.33|0.0102
70970895|NCT01445951|141447711|SUPERIORITY_OR_OTHER|||||||0.4955|||||||t-test, 2 sided|||Within treatment analysis of change from Baseline comparing if change was different from zero||||0.4955
70970896|NCT01445951|141447711|SUPERIORITY_OR_OTHER|||||||0.6807|||||||t-test, 2 sided|||Within treatment analysis of change from Baseline comparing if change was different from zero||||0.6807
70970897|NCT01445951|141447711|SUPERIORITY_OR_OTHER|||||||0.0079|||||||t-test, 2 sided|||Within treatment analysis of change from Baseline comparing if change was different from zero||||0.0079
70970898|NCT01445951|141447713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5328||||0.0156|TWO_SIDED|95.0|0.3198|0.8877|||Regression, Logistic|Logistic model with affects for Region, Basal insulin stratum, and Treatment||||0.8877|0.3198|0.0156
70970899|NCT01445951|141447714|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Negative Binomial Regression|Model: Region + Basal Insulin Stratum + Treatment + Exposure Time||||||<0.0001
70970900|NCT01445951|141447715|SUPERIORITY_OR_OTHER|||||||0.1022|||||||Negative Binomial Regression|Model: Region + Basal Insulin Stratum + Treatment + Exposure Time||||||0.1022
70970901|NCT01445951|141447716|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.449||||0.0158|TWO_SIDED|95.0|0.23|0.86|||Regression, Logistic|Model: Treatment + Basal insulin stratum + Region + Baseline HbA1c|Gen2 in the numerator, Aspart in the denominator|||0.86|0.23|0.0158
70970902|NCT03817775|141447719|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
70970903|NCT03817775|141447720|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
70970904|NCT03817775|141447721|OTHER|||||||0.7215|||||||Wilcoxon (Mann-Whitney)|||||||0.7215
70970905|NCT03817775|141447722|OTHER|||||||0.5675|||||||Wilcoxon (Mann-Whitney)|||||||0.5675
70970906|NCT03817775|141447723|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
70970907|NCT00350142|141447729|SUPERIORITY_OR_OTHER||proportion|0.75|||||TWO_SIDED|||||||||||||
70970908|NCT00610987|141447739|SUPERIORITY_OR_OTHER||||||=|0.12|TWO_SIDED||||||t-test, 1 sided|||||||=0.12
71153957|NCT00488683|141800067|SUPERIORITY_OR_OTHER||R-square|0.07||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup C||||
70970909|NCT00254501|141447740|SUPERIORITY_OR_OTHER|||||||0.0757||||||Adjusted for baseline Hemoglobin A-1C.|ANCOVA|||"Null hypothesis is mean change in usual care group equals mean change in Empower group.~Power calculation required 150 per group assuming 25% would withdraw prior to 12 months."||||0.0757
70970910|NCT00254501|141447741|SUPERIORITY_OR_OTHER|||||||0.44|||||||ANCOVA|||Comparison of change in LDL from baseline to 12 months between groups.||||0.44
70970911|NCT00254501|141447741|SUPERIORITY_OR_OTHER|||||||0.16|||||||ANCOVA|||Comparison of change in HDL from baseline to 12 months between groups.||||0.16
70970912|NCT00254501|141447741|SUPERIORITY_OR_OTHER|||||||0.14|||||||ANCOVA|||Comparison of change in total cholesterol from baseline to 12 months between groups.||||0.14
70970913|NCT00254501|141447741|SUPERIORITY_OR_OTHER|||||||0.92|||||||ANCOVA|||Comparison of change in triglycerides from baseline to 12 months between groups.||||0.92
70970914|NCT00254501|141447742|SUPERIORITY_OR_OTHER|||||||0.3856|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in cost of total health care from baseline to 12 months between groups. Analyses not adjusted for other variables.||||.3856
70970915|NCT00254501|141447742|SUPERIORITY_OR_OTHER|||||||0.6413|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in cost of diabetes medications from baseline to 12 months between groups. Analyses not adjusted for other variables.||||.6413
70970916|NCT00254501|141447742|SUPERIORITY_OR_OTHER|||||||0.4303|||||||Wilcoxon (Mann-Whitney)|||Analyses not adjusted for other variables.||||.4303
70970917|NCT00254501|141447743|SUPERIORITY_OR_OTHER|||||||0.785|||||||ANCOVA|||Comparison of change in Diabetes Empowerment Scale from baseline to 12 months between groups.||||0.785
70970918|NCT00254501|141447743|SUPERIORITY_OR_OTHER|||||||0.302|||||||ANCOVA|||Comparison of change in Adherence Starts with Knowledge (ASK-20) from baseline to 12 months between groups.||||0.302
70970919|NCT00254501|141447743|SUPERIORITY_OR_OTHER|||||||0.0024|||||||ANCOVA|||Comparison of change in Understanding of Diabetes from baseline to 12 months between groups.||||0.0024
70970920|NCT00781456|141447804|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.02|STANDARD_ERROR_OF_MEAN|0.43||0.954|TWO_SIDED|95.0|-0.82|0.87|||Regression, Logistic|Logistic regression model with terms of treatment, weekly baseline migraine frequency, and center included in the model.|91-day Levonogestrel Oral Contraceptive versus placebo. Treatment Difference was estimated using logistic regression for the proportion of participants with \>=50% reduction in migraine frequency during the treatment period.|||0.87|-0.82|0.954
70970921|NCT00781456|141447805|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.31|STANDARD_ERROR_OF_MEAN|0.44||0.479|TWO_SIDED|95.0|-0.55|1.17||No adjustment for multiple comparisons was performed.|Regression, Logistic|Logistic regression model with terms of treatment, baseline weekly migraine frequency and center included in the model.|91-day Levonogestrel Oral Contraceptive versus placebo. Treatment Difference was estimated using logistic regression for the proportion of participants with \>=50% reduction in migraine frequency during the treatment period.|Comparison of percentage of participants with a reduction of 50% or more in migraine frequency during the first month of treatment.||1.17|-0.55|0.479
70970922|NCT00781456|141447805|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.5|STANDARD_ERROR_OF_MEAN|0.44||0.256|TWO_SIDED|95.0|-0.36|1.37||No adjustment for multiple comparisons was performed.|Regression, Logistic|Logistic regression model with terms of treatment, baseline weekly migraine frequency and center included in the model.|91-day Levonogestrel Oral Contraceptive versus placebo. Treatment Difference was estimated using logistic regression for the proportion of participants with \>=50% reduction in migraine frequency during the treatment period.|Comparison of percentage of participants with a reduction of 50% or more in migraine frequency during the second month of treatment||1.37|-0.36|0.256
70970923|NCT00781456|141447805|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.14|STANDARD_ERROR_OF_MEAN|0.52||0.788|TWO_SIDED|95.0|-1.16|0.88||No adjustment for multiple comparisons was performed.|Regression, Logistic|Logistic regression model with terms of treatment, baseline weekly migraine frequency and center included in the model.|91-day Levonogestrel Oral Contraceptive versus placebo. Treatment Difference was estimated using logistic regression for the proportion of participants with \>=50% reduction in migraine frequency during the treatment period.|Comparison of percentage of participants with a reduction of 50% or more in migraine frequency during the third month of treatment.||0.88|-1.16|0.788
70970924|NCT00781456|141447806|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.19||||0.182|TWO_SIDED|95.0|-0.47|0.09|||ANCOVA|Treatment comparison was performed using an analysis of covariance model with baseline average migraine severity and center as covariates.|91-day Levonogestrel Oral Contraceptive versus placebo.|Comparison of change from Baseline in migraine severity during the 91-day treatment period.||0.09|-0.47|0.182
70970925|NCT00781456|141447806|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.04||||0.853|TWO_SIDED|95.0|-0.71|0.19|||ANCOVA|Treatment comparison was performed using an analysis of covariance model with baseline average migraine severity and center as covariates.|91-day Levonogestrel Oral Contraceptive versus placebo.|Comparison of change from Baseline in migraine severity during the first month of treatment||0.19|-0.71|0.853
70970926|NCT00781456|141447806|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.26||||0.249|TWO_SIDED|95.0|-0.71|0.19|||ANCOVA|Treatment comparison was performed using an analysis of covariance model with baseline average migraine severity and center as covariates.|91-day Levonogestrel Oral Contraceptive versus placebo.|Comparison of change from Baseline in migraine severity during the second month of treatment||0.19|-0.71|0.249
70970927|NCT00781456|141447806|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.4||||0.119|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|Treatment comparison was performed using an analysis of covariance model with baseline average migraine severity and center as covariates.|91-day Levonogestrel Oral Contraceptive versus placebo.|Comparison of change from Baseline in migraine severity during the third month of treatment||0.10|-0.90|0.119
70970928|NCT00781456|141447807|SUPERIORITY_OR_OTHER|||||||0.457|||||||Cochran-Mantel-Haenszel|||Comparison of percentage of participants requiring rescue medication during the first month of treatment.||||0.457
70970929|NCT00781456|141447807|SUPERIORITY_OR_OTHER|||||||0.361|||||||Cochran-Mantel-Haenszel|||Comparison of percentage of participants requiring rescue medication during the second month of treatment.||||0.361
70970930|NCT00781456|141447807|SUPERIORITY_OR_OTHER|||||||0.018|||||||Cochran-Mantel-Haenszel|||Comparison of percentage of participants requiring rescue medication during the third month of treatment.||||0.018
70970931|NCT00781456|141447807|SUPERIORITY_OR_OTHER|||||||0.709|||||||Cochran-Mantel-Haenszel|||Comparison of percentage of participants requiring rescue medication during the 91-day treatment period.||||0.709
70970932|NCT00783094|141447813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.201|TWO_SIDED|95.0|-1.8|0.4|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no), and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo|||0.4|-1.8|0.201
70970933|NCT00783094|141447813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.6||0.062|TWO_SIDED|95.0|-2.2|0.1|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 5 mg - Placebo.|||0.1|-2.2|0.062
70970934|NCT00783094|141447814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.356|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo.|||0.2|-0.7|0.356
70970935|NCT00783094|141447814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.487|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 5 mg - Placebo.|||0.3|-0.6|0.487
70970936|NCT00783094|141447815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.228|TWO_SIDED|95.0|-1.3|0.3|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo|||0.3|-1.3|0.228
70970937|NCT00783094|141447815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.4||0.033|TWO_SIDED|95.0|-1.7|-0.1|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 5 mg - Placebo.|||-0.1|-1.7|0.033
70970938|NCT00783094|141447816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.249|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|With effects for treatment,BPH severity (moderate/severe), prior alpha blocker use (yes/no), and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo.|||0.1|-0.4|0.249
70970939|NCT00783094|141447816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.022|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|With effects for treatment,BPH severity (moderate/severe), prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 5 mg - Placebo.|||-0.0|-0.6|0.022
70970940|NCT00783094|141447817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.904|TWO_SIDED|95.0|-0.4|0.3|||ANCOVA|with effects for treatment,BPH severity (moderate/severe), prior alpha blocker use (yes/no), and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo.|||0.3|-0.4|0.904
70970941|NCT00783094|141447817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.8|TWO_SIDED|95.0|-0.4|0.3|||ANCOVA|With effects for treatment, BPH severity(moderate/severe), prior alpha blocker use (yes/no), and baseline value.||||0.3|-0.4|0.800
70970942|NCT00783094|141447818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.4||0.147|TWO_SIDED|95.0|-1.5|0.2|||ANCOVA|With effects for treatment, BPH severity (moderate/severe), prior alpha blocker use (yes/no), and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo.|||0.2|-1.5|0.147
71153958|NCT00488683|141800067|SUPERIORITY_OR_OTHER||R-square|1.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup W-135||||
70970943|NCT00783094|141447818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.4||0.094|TWO_SIDED|95.0|-1.6|0.1|||ANCOVA|With effects for treatment, BPH severity (moderate/severe), prior alpha blocker use (yes/no), and baseline value.|Least Squares Mean Difference = Tadalafil 5 mg - Placebo.|||0.1|-1.6|0.094
70970944|NCT00783094|141447821|SUPERIORITY_OR_OTHER|||||||0.342||95.0||||P-Value for systolic blood pressure.|Wilcoxin rank-sum test|||||||0.342
70970945|NCT00783094|141447821|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||P-Value for systolic blood pressure.|Wilcoxin rank sum test|||||||0.127
70970946|NCT00783094|141447821|SUPERIORITY_OR_OTHER|||||||0.705||95.0||||P-Value for diastolic blood pressure.|Wilcoxin rank-sum test|||||||0.705
71153959|NCT00488683|141800067|SUPERIORITY_OR_OTHER||R-square|0.29||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup W-135||||
70970947|NCT00783094|141447821|SUPERIORITY_OR_OTHER|||||||0.173||95.0||||P-Value for diastolic blood pressure.|Wilcoxin rank-sum test|||||||0.173
70970948|NCT00783094|141447822|SUPERIORITY_OR_OTHER|||||||0.606||95.0|||||Wilcoxin rank-sum test|||||||0.606
70970949|NCT00783094|141447822|SUPERIORITY_OR_OTHER|||||||0.149||95.0|||||Wilcoxin rank-sum test|||||||0.149
70970950|NCT00783094|141447823|SUPERIORITY_OR_OTHER|||||||0.428||95.0|||||Wilcoxin rank-sum test|||||||0.428
70970951|NCT00783094|141447823|SUPERIORITY_OR_OTHER|||||||0.426||95.0|||||Wilcoxin rank-sum test|||||||0.426
71093251|NCT05168800|141693787|EQUIVALENCE|A sample size of 1800 LTCWs (600 per arm) was identified to provide 80% power to detect an 8% difference in the rate of individuals reporting vaccine confidence between arms with 95% confidence. This sample size was sufficient to retain 80% power to detect a 10% difference after 40% attrition. Per study design, the equivalence margin is +/- 10% with anticipated attrition using the binomial confidence interval.||||||0.85||||||To achieve a group-wise 95% confidence for the primary outcome, each of the three tests were evaluated with acceptance based on a 98.4% confidence interval, or +/- 2.45 standard deviations of the mean for the equivalency test.|Groupwise binomial comparison|||||||0.85
70970952|NCT00783094|141447824|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Wilcoxin rank-sum|||||||0.060
70970953|NCT00783094|141447824|SUPERIORITY_OR_OTHER|||||||0.212||95.0|||||Wilcoxin rank-sum|||||||0.212
70970954|NCT00876187|141447838|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.21||0.113|TWO_SIDED|95.0|-0.74|0.08|||ANCOVA|||Treatment difference and 95 percent (%) confidence interval (CI) was based on least squares (LS) mean. Analysis of Covariance (ANCOVA) was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.08|-0.74|0.113
70970955|NCT00876187|141447838|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.19|-0.42|||ANCOVA|||Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.42|-1.19|<0.001
70970956|NCT00876187|141447838|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.31|-0.54|||ANCOVA|||Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.54|-1.31|<0.001
70970957|NCT00876187|141447838|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.2||0.688|TWO_SIDED|95.0|-0.31|0.47|||ANCOVA|||Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.47|-0.31|0.688
70970958|NCT00876187|141447838|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.19||0.035|TWO_SIDED|95.0|-0.76|-0.03|||ANCOVA|||Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.03|-0.76|0.035
70970959|NCT00876187|141447838|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.19||0.006|TWO_SIDED|95.0|-0.88|-0.15|||ANCOVA|||Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.15|-0.88|0.006
70970960|NCT00876187|141447841|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.18||0.221|TWO_SIDED|95.0|-0.57|0.13|||ANCOVA|||Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.13|-0.57|0.221
70970961|NCT00876187|141447841|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-0.9|-0.24|||ANCOVA|||Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.24|-0.90|<0.001
70970962|NCT00876187|141447841|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.17||0.027|TWO_SIDED|95.0|-0.7|-0.04|||ANCOVA|||Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.04|-0.70|0.027
70970963|NCT00876187|141447841|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.17||0.082|TWO_SIDED|95.0|-0.04|0.62|||ANCOVA|||Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.62|-0.04|0.082
70970964|NCT00876187|141447841|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.16||0.703|TWO_SIDED|95.0|-0.37|0.25|||ANCOVA|||Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.25|-0.37|0.703
70970965|NCT00876187|141447841|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.16||0.379|TWO_SIDED|95.0|-0.17|0.45|||ANCOVA|||Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.45|-0.17|0.379
70970966|NCT00876187|141447841|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.19||0.012|TWO_SIDED|95.0|-0.87|-0.11|||ANCOVA|||Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.11|-0.87|0.012
70970967|NCT00876187|141447841|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.39|-0.67|||ANCOVA|||Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.67|-1.39|<0.001
70970968|NCT00876187|141447841|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.31|-0.58|||ANCOVA|||Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.58|-1.31|<0.001
70970969|NCT00876187|141447841|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.18||0.862|TWO_SIDED|95.0|-0.33|0.39|||ANCOVA|||Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.39|-0.33|0.862
70970970|NCT00876187|141447841|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.17||0.003|TWO_SIDED|95.0|-0.85|-0.17|||ANCOVA|||Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.17|-0.85|0.003
70970971|NCT00876187|141447841|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.17||0.014|TWO_SIDED|95.0|-0.76|-0.09|||ANCOVA|||Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.09|-0.76|0.014
70970972|NCT00876187|141447841|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.2||0.019|TWO_SIDED|95.0|-0.86|-0.08|||ANCOVA|||Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.08|-0.86|0.019
70970973|NCT00876187|141447841|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.25|-0.51|||ANCOVA|||Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.51|-1.25|<0.001
70970974|NCT00876187|141447841|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.29|-0.56|||ANCOVA|||Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.56|-1.29|<0.001
70970975|NCT00876187|141447841|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.19||0.668|TWO_SIDED|95.0|-0.45|0.29|||ANCOVA|||Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.29|-0.45|0.668
70970976|NCT00876187|141447841|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.18||0.005|TWO_SIDED|95.0|-0.84|-0.15|||ANCOVA|||Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.15|-0.84|0.005
70970977|NCT00876187|141447841|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.18||0.002|TWO_SIDED|95.0|-0.88|-0.19|||ANCOVA|||Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.19|-0.88|0.002
70970978|NCT00876187|141447841|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.22||0.032|TWO_SIDED|95.0|-0.89|-0.04|||ANCOVA|||Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.04|-0.89|0.032
70970979|NCT00876187|141447841|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.21|-0.41|||ANCOVA|||Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.41|-1.21|<0.001
70970980|NCT00876187|141447841|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.28|-0.48|||ANCOVA|||Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.48|-1.28|<0.001
71093252|NCT05168800|141693788|SUPERIORITY|||||||0.93|||||||Fisher Exact|||||||0.93
70970981|NCT00876187|141447841|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.2||0.773|TWO_SIDED|95.0|-0.46|0.34|||ANCOVA|||Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.34|-0.46|0.773
70970982|NCT00876187|141447841|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.035|TWO_SIDED|95.0|-0.78|-0.03|||ANCOVA|||Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.03|-0.78|0.035
70970983|NCT00876187|141447841|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.19||0.014|TWO_SIDED|95.0|-0.85|-0.1|||ANCOVA|||Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.10|-0.85|0.014
70970984|NCT02429414|141447888|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70970985|NCT02429414|141447889|SUPERIORITY|||||||0.0209|||||||t-test, 2 sided|||||||0.0209
70970986|NCT02429414|141447890|SUPERIORITY|||||||0.078|||||||t-test, 2 sided|||||||0.078
70970987|NCT00794677|141447927|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.252|STANDARD_ERROR_OF_MEAN|0.112||0.03||95.0|||||ANOVA|||Statistical significance was determined for a standard two-period crossover design using JMP software (Version 5.0, SAS Institute. Cary, NC).||||0.03
70970988|NCT00794677|141447928|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.273|STANDARD_ERROR_OF_MEAN|0.102||0.01||95.0|||||ANOVA|||||||0.01
70970989|NCT00794677|141447929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.048|STANDARD_ERROR_OF_MEAN|0.089||0.6||95.0|||||ANOVA|||||||0.60
70970990|NCT00794677|141447930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.47||0.67||95.0|||||ANOVA|||||||0.67
70970991|NCT00794677|141447931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.14||0.3||95.0|||||ANOVA|||||||0.30
70970992|NCT00794677|141447932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-15.412|STANDARD_ERROR_OF_MEAN|1.569|<|0.0001|TWO_SIDED|95.0|||||ANOVA|||||||<0.0001
70970993|NCT00794677|141447933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-21.846|STANDARD_ERROR_OF_MEAN|2.866|<|1e-07|TWO_SIDED|95.0|||||ANOVA|||||||<0.0000001
70970994|NCT00794677|141447934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.397|STANDARD_ERROR_OF_MEAN|1.893||0.009|TWO_SIDED|95.0|||||ANOVA|||||||0.009
70970995|NCT00794677|141447935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-21.353|STANDARD_ERROR_OF_MEAN|2.22|<|1e-07|TWO_SIDED|95.0|||||ANOVA|||||||<0.0000001
71031798|NCT02728102|141572288|SUPERIORITY|||||||0.161||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Myeloma Progression between vaccine vs. non- vaccine arms.||||0.161
71031799|NCT02728102|141572289|SUPERIORITY|||||||0.116||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Myeloma Progression between the vaccine arm and lenalidomide/GM-CSF arm.||||0.116
71031800|NCT02728102|141572289|SUPERIORITY|||||||0.519||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Myeloma Progression between the vaccine arm and lenalidomide alone arm.||||0.519
71093253|NCT05168800|141693788|SUPERIORITY|||||||0.9|||||||Fisher Exact|||||||0.90
70970996|NCT03015259|141447953|EQUIVALENCE|To show the clinical equivalence, an analysis of covariance model was fit on the participants from the test budesonide/formoterol fumarate and Symbicort groups, with the endpoint as outcome and treatment, study site and treatment by site interaction as fixed effects and FEV1 baseline value as covariate.|Test/Referece LS Mean Ratio|1.04|||||TWO_SIDED|90.0|0.958|1.13|||||Fieller's formula was applied|Only Treatments 1 and 2 were compared for equivalence. Treatment 3 (placebo) was subtracted from both Treatments 1 and 2, as this primary endpoint was baseline adjusted.||1.130|0.958|
70970997|NCT03015259|141447954|EQUIVALENCE|To show the clinical equivalence, an ANCOVA model was fit with the endpoint as outcome and treatment, study site and treatment-by site interaction as fixed effects and FEV1 baseline value as covariate.|Test/Reference LS Mean Ratio|1.004|||||TWO_SIDED|90.0|0.889|1.14|||||Fieller's formula was applied|Treatments 1 and 2 were baseline adjusted by subtracting Treatment 3 (placebo) from each.||1.140|0.889|
70970998|NCT03015259|141447955|OTHER|||||||||||||||||Comparison of means, no formal statistical comparison|no statistical significance applied|||
70970999|NCT00143312|141447991|SUPERIORITY_OR_OTHER||Crude IFI Rate (percent) at 12 months|7.0||||||95.0|2.0|19.0||||||||19|2|
70971000|NCT00143312|141447991|SUPERIORITY_OR_OTHER||IFI Rate (percent) at 12 months|10.0||||||95.0|2.0|27.0||||||||27|2|
70971001|NCT00143312|141447992|SUPERIORITY_OR_OTHER||IFI Rate (percent) at 6 months|8.82||||||95.0|2.0|24.0|||||Exact 95% Confidence Interval For Proportion; Expressed as a percentage|||24|2|
70971002|NCT00143312|141447993|SUPERIORITY_OR_OTHER||IFI Rate (percent) at End of Prophylaxis|8.82||||||95.0|2.0|24.0|||||Exact 95% Confidence Interval For Proportion; Expressed as a percentage|||24|2|
70971003|NCT00143312|141447997|SUPERIORITY_OR_OTHER||survive free of IFI (percent): 6 months|79.0||||||95.0|64.0|91.0|||||Exact 95% Confidence Interval For Proportion; Expressed as a percentage|||91|64|
70971004|NCT00143312|141447997|SUPERIORITY_OR_OTHER||survive free of IFI (percent): 12 months|69.0||||||95.0|52.0|83.0|||||Exact 95% Confidence Interval For Proportion; Expressed as a percentage|||83|52|
70971005|NCT02500628|141448005|OTHER|||||||0.77|||||||t-test, 2 sided|||comparison between fibromyalgia and non-fibromyalgia group||||0.77
70971006|NCT02500628|141448006|OTHER|||||||0.27|||||||t-test, 2 sided|||||||0.27
70971007|NCT02500628|141448007|OTHER|||||||0.92|||||||t-test, 2 sided|||difference between fibromyalgia and non-fibromyalgia patients.||||0.92
70971008|NCT01627860|141448013|SUPERIORITY_OR_OTHER||Difference in Seizure free rate|23.57||||0.0759|TWO_SIDED|95.0|-4.21|49.0|||ANOVA||Difference in Seizure free rate (Monotherapy minus Add on therapy)|||49.00|-4.21|0.0759
70971009|NCT01627860|141448014|SUPERIORITY_OR_OTHER||Difference in mean percent change|18.3||||0.7102|TWO_SIDED|95.0|-81.0|117.7|||ANCOVA||Difference in mean percent change of seizure frequency (Monotherapy minus Add on therapy)|||117.7|-81.0|0.7102
70971010|NCT04770389|141448027|SUPERIORITY||Least Squares (LS) Mean|-44.92|STANDARD_ERROR_OF_MEAN|5.183|<|0.0001|TWO_SIDED|95.0|-55.2|-34.63|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-34.63|-55.20|<0.0001
70971011|NCT04770389|141448028|SUPERIORITY||Least Squares (LS) Mean|-44.92|STANDARD_ERROR_OF_MEAN|5.183|<|0.0001|TWO_SIDED|95.0|-55.2|-34.63|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-34.63|-55.20|<0.0001
70971012|NCT04770389|141448029|SUPERIORITY||Least Squares (LS) Mean|-44.92|STANDARD_ERROR_OF_MEAN|5.183|<|0.0001|TWO_SIDED|95.0|-55.2|-34.63|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-34.63|-55.20|<0.0001
70971013|NCT04770389|141448030|SUPERIORITY||Least Squares (LS) Mean|-43.33|STANDARD_ERROR_OF_MEAN|5.517|<|0.0001|TWO_SIDED|95.0|-54.29|-32.36|||ANCOVA|||||-32.36|-54.29|<0.0001
70971014|NCT04770389|141448031|SUPERIORITY||Least Squares (LS) Mean|-43.33|STANDARD_ERROR_OF_MEAN|5.517|<|0.0001|TWO_SIDED|95.0|-54.29|-32.36|||ANCOVA|||||-32.36|-54.29|<0.0001
70971015|NCT04770389|141448032|SUPERIORITY||Least Squares (LS) Mean|-43.33|STANDARD_ERROR_OF_MEAN|5.517|<|0.0001|TWO_SIDED|95.0|-54.29|-32.36|||ANCOVA|||||-32.36|-54.29|<0.0001
70971016|NCT04770389|141448033|SUPERIORITY||Least Squares (LS) Means|-33.36|STANDARD_ERROR_OF_MEAN|5.176|<|0.0001|TWO_SIDED|95.0|-43.63|-23.09|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-23.09|-43.63|<0.0001
70971017|NCT04770389|141448034|SUPERIORITY||Least Squares (LS) Mean|-33.36|STANDARD_ERROR_OF_MEAN|5.176|<|0.0001|TWO_SIDED|95.0|-43.63|-23.09|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-23.09|-43.63|<0.0001
71093254|NCT05168800|141693788|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.83|||||||Fisher Exact|||||||0.83
71093255|NCT05168800|141693789|SUPERIORITY|||||||0.22|||||||Fisher Exact|||||||0.22
70971018|NCT04770389|141448035|SUPERIORITY||Least Squares (LS) Mean|-33.36|STANDARD_ERROR_OF_MEAN|5.176|<|0.0001|TWO_SIDED|95.0|-43.63|-23.09|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-23.09|-43.63|<0.0001
70971019|NCT04770389|141448036|SUPERIORITY||Least Squares (LS) Mean|-28.2|STANDARD_ERROR_OF_MEAN|5.596|<|0.0001|TWO_SIDED|95.0|-39.32|-17.08|||ANCOVA|||||-17.08|-39.32|<0.0001
70971020|NCT04770389|141448037|SUPERIORITY||Least Squares (LS) Mean|-28.2|STANDARD_ERROR_OF_MEAN|5.596|<|0.0001|TWO_SIDED|95.0|-39.32|-17.08|||ANCOVA|||||-17.08|-39.32|<0.0001
70971021|NCT04770389|141448038|SUPERIORITY||Least Squares (LS) Mean|-28.2|STANDARD_ERROR_OF_MEAN|5.596|<|0.0001|TWO_SIDED|95.0|-39.32|-17.08|||ANCOVA|||||-17.08|-39.32|<0.0001
70971022|NCT04770389|141448039|SUPERIORITY||Least Squares (LS) Means|-29.62|STANDARD_ERROR_OF_MEAN|3.78|<|0.0001|TWO_SIDED|95.0|-37.12|-22.12|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-22.12|-37.12|<0.0001
70971023|NCT04770389|141448040|SUPERIORITY||Least Squares (LS) Mean|-29.62|STANDARD_ERROR_OF_MEAN|3.78|<|0.0001|TWO_SIDED|95.0|-37.12|-22.12|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-22.12|-37.12|<0.0001
70971024|NCT04770389|141448041|SUPERIORITY||Least Squares (LS) Means|-29.62|STANDARD_ERROR_OF_MEAN|3.78|<|0.0001|TWO_SIDED|95.0|-37.12|-22.12|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-22.12|-37.12|<0.0001
71093256|NCT05168800|141693789|SUPERIORITY|||||||0.43|||||||Fisher Exact|||||||0.43
71093257|NCT05168800|141693789|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.61|||||||Fisher Exact|||||||0.61
71093258|NCT05168800|141693790|SUPERIORITY|||||||0.65|||||||Fisher Exact|||||||0.65
71093259|NCT05168800|141693790|SUPERIORITY|||||||0.34|||||||Fisher Exact|||||||0.34
71093260|NCT05168800|141693790|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.48|||||||Fisher Exact|||||||0.48
70971025|NCT04770389|141448042|SUPERIORITY||Least Squares (LS) Mean|-22.36|STANDARD_ERROR_OF_MEAN|3.768|<|0.0001|TWO_SIDED|95.0|-29.83|-14.88|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.88|-29.83|<0.0001
70971026|NCT04770389|141448043|SUPERIORITY||Least Squares (LS) Mean|-22.36|STANDARD_ERROR_OF_MEAN|3.768|<|0.0001|TWO_SIDED|95.0|-29.83|-14.88|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.88|-29.83|<0.0001
70971027|NCT04770389|141448044|SUPERIORITY||Least Squares (LS) Mean|-22.36|STANDARD_ERROR_OF_MEAN|3.768|<|0.0001|TWO_SIDED|95.0|-29.83|-14.88|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.88|-29.83|<0.0001
70971028|NCT04770389|141448045|SUPERIORITY||Least Squares (LS) Means|-30.13|STANDARD_ERROR_OF_MEAN|5.254|<|0.0001|TWO_SIDED|95.0|-40.55|-19.71|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-19.71|-40.55|<0.0001
70971029|NCT04770389|141448046|SUPERIORITY||Least Squares (LS) Mean|-30.13|STANDARD_ERROR_OF_MEAN|5.254|<|0.0001|TWO_SIDED|95.0|-40.55|-19.71|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-19.71|-40.55|<0.0001
70971030|NCT04770389|141448047|SUPERIORITY||Least Squares (LS) Mean|-30.13|STANDARD_ERROR_OF_MEAN|5.254|<|0.0001|TWO_SIDED|95.0|-40.55|-19.71|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-19.71|-40.55|<0.0001
70971031|NCT04770389|141448048|SUPERIORITY||Least Squares (LS) Means|-18.58|STANDARD_ERROR_OF_MEAN|5.196||0.0005|TWO_SIDED|95.0|-28.88|-8.27|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-8.27|-28.88|0.0005
70971032|NCT04770389|141448049|SUPERIORITY||Least Squares (LS) Mean|-18.58|STANDARD_ERROR_OF_MEAN|5.196||0.0005|TWO_SIDED|95.0|-28.88|-8.27|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-8.27|-28.88|0.0005
70971033|NCT04770389|141448050|SUPERIORITY||Least Squares (LS) Mean|-18.58|STANDARD_ERROR_OF_MEAN|5.196||0.0005|TWO_SIDED|95.0|-28.88|-8.27|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-8.27|-28.88|0.0005
70971034|NCT04770389|141448051|SUPERIORITY||Least Squares (LS) Means|-14.79|STANDARD_ERROR_OF_MEAN|5.165||0.0051|TWO_SIDED|95.0|-25.03|-4.54|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-4.54|-25.03|0.0051
70971035|NCT04770389|141448052|SUPERIORITY||Least Squares (LS) Mean|-14.79|STANDARD_ERROR_OF_MEAN|5.165||0.0051|TWO_SIDED|95.0|-25.03|-4.54|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-4.54|-25.03|0.0051
70971036|NCT04770389|141448053|SUPERIORITY||Least Squares (LS) Mean|-14.79|STANDARD_ERROR_OF_MEAN|5.165||0.0051|TWO_SIDED|95.0|-25.03|-4.54|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-4.54|-25.03|0.0051
70971037|NCT04770389|141448054|SUPERIORITY||Least Squares (LS) Mean|-12.77|STANDARD_ERROR_OF_MEAN|5.58||0.0245|TWO_SIDED|95.0|-23.86|-1.68|||ANCOVA|||||-1.68|-23.86|0.0245
70971038|NCT04770389|141448055|SUPERIORITY||Least Squares (LS) Mean|-12.77|STANDARD_ERROR_OF_MEAN|5.58||0.0245|TWO_SIDED|95.0|-23.86|-1.68|||ANCOVA|||||-1.68|-23.86|0.0245
70971039|NCT04770389|141448056|SUPERIORITY||Least Squares (LS) Mean|-12.77|STANDARD_ERROR_OF_MEAN|5.58||0.0245|TWO_SIDED|95.0|-23.86|-1.68|||ANCOVA|||||-1.68|-23.86|0.0245
70971040|NCT04770389|141448057|SUPERIORITY||Least Squares (LS) Mean|-20.81|STANDARD_ERROR_OF_MEAN|3.822|<|0.0001|TWO_SIDED|95.0|-28.39|-13.22|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-13.22|-28.39|<0.0001
70971041|NCT04770389|141448058|SUPERIORITY||Least Squares (LS) Mean|-20.81|STANDARD_ERROR_OF_MEAN|3.822|<|0.0001|TWO_SIDED|95.0|-28.39|-13.22|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-13.22|-28.39|<0.0001
70971042|NCT04770389|141448059|SUPERIORITY||Least Squares (LS) Mean|-20.81|STANDARD_ERROR_OF_MEAN|3.822|<|0.0001|TWO_SIDED|95.0|-28.39|-13.22|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-13.22|-28.39|<0.0001
70971043|NCT02249143|141448061|SUPERIORITY||Mean Difference (Net)|6.62|||<|0.05|TWO_SIDED|95.0|0.02|13.22|||Regression, Linear|||FRC values over time were modeled using linear mixed effects regression with treatment group vs. time interaction and repeated measures for the randomization, 2 week, and discharge time points. Compound symmetric covariance structures were used to account for the correlation of FRC values within each patient. We compared outcomes between the two treatment groups and included adjustments for gender, twin gestation, and weight at randomization.||13.22|0.02|<0.05
70971044|NCT02249143|141448062|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71093261|NCT05168800|141693791|SUPERIORITY|||||||0.88|||||||Adjusted Wald test|||||||0.88
71093262|NCT05168800|141693791|SUPERIORITY|||||||0.97|||||||Adjusted Wald test|||||||0.97
71093263|NCT05168800|141693791|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.48|||||||Adjusted Wald test|||||||0.48
71093264|NCT05168800|141693792|SUPERIORITY|||||||0.95|||||||Adjusted Wald test|||||||0.95
70971045|NCT02249143|141448062|SUPERIORITY|||||||||||||||||Group differences in the secondary outcomes were tested at randomization, two weeks, and discharge using independent samples t-tests.||||
70971046|NCT01783080|141448074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.4||||0.005|TWO_SIDED||||||Regression, Linear|||||||0.005
70971047|NCT01783080|141448076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.11|TWO_SIDED||||||Regression, Linear|||||||0.11
70971048|NCT02533063|141448080|SUPERIORITY|||||||0.217|||||||ANOVA|||||||0.217
70971049|NCT02533063|141448081|SUPERIORITY|||||||0.501|||||||ANOVA|||||||0.501
70971050|NCT02533063|141448082|SUPERIORITY|||||||0.151|||||||ANOVA|||||||0.151
70971051|NCT02533063|141448083|SUPERIORITY|||||||0.45|||||||ANOVA|||||||0.450
70971052|NCT02533063|141448084|SUPERIORITY|||||||0.678|||||||ANOVA|||||||0.678
70971053|NCT02533063|141448085|SUPERIORITY|||||||0.06|||||||ANOVA|||||||0.060
70971054|NCT02533063|141448088|SUPERIORITY|||||||0.483|||||||ANOVA|||||||0.483
70971055|NCT00802204|141448109|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|describe.....||Baseline outcome measurements are compared between lean and obese. Baseline and post outcome measurements are compared for the obese who completed VLCD||||<0.05
71093265|NCT05168800|141693792|SUPERIORITY|||||||0.98|||||||Adjusted Wald test|||||||0.98
71093266|NCT05168800|141693792|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.66|||||||Adjusted Wald test|||||||0.66
71093267|NCT05168800|141693793|SUPERIORITY|||||||0.08|||||||Fisher Exact|||||||0.08
70971056|NCT00802204|141448109|OTHER||||||<|0.05|||||||t-test, 2 sided|||Paired t-test to compare baseline and post-diet outcome measures||||<0.05
70971057|NCT02701387|141448150|SUPERIORITY_OR_OTHER||||||<|0.01||||||"A 2-factor (implant type x time interval) nonparametric analysis for longitudinal data (Brunner et al. 2002) was used to compare test and control implants across time (baseline + four intervals). The R package nparLD was used (Noguchi et al. 2012)."|nonparametric for longitudinal|||Comparison of ISQ over time. Due to the high number of intervals (T0-T8) relative to the number of observations, data were combined for analysis purposes into 5 comparable intervals as follows: Baseline (T0, unchanged); Tr1=Average of follow-up weeks T1 and T2, Tr2=Average of follow-up weeks T3 and T4; Tr3=Average of follow-up weeks T5 and T6; Tr4=Average of follow-up weeks T7 and T8||||<0.01
70971058|NCT02043548|141448151|SUPERIORITY|||||||0.86|||||||GEE|||||||0.86
70971059|NCT02043548|141448152|SUPERIORITY|||||||0.77|||||||Log Rank|||||||0.77
70971060|NCT02043548|141448153|SUPERIORITY|||||||0.4|||||||binomial test|||||||0.40
70971061|NCT02043548|141448154|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.40
70971062|NCT02043548|141448155|SUPERIORITY|||||||0.78|||||||GEE|||||||0.78
70971063|NCT02043548|141448155|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||||||0.19
70971064|NCT01500759|141448176|OTHER||Odds Ratio (OR)|1.9|||||TWO_SIDED|95.0||||||||||||
70971065|NCT01500759|141448177|OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0||||||||||||
70971066|NCT01500759|141448178|OTHER||Odds Ratio (OR)|0.92|||||TWO_SIDED|||||||||||||
70971067|NCT01500759|141448179|OTHER||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0||||||||||||
70971068|NCT01290874|141448182|SUPERIORITY|||||||0.31|||||||Log Rank|||||||0.31
70971069|NCT03829657|141448202|SUPERIORITY||Odds Ratio (OR)|0.6||||0.196|TWO_SIDED|95.0|0.27|1.29|||Regression, Logistic|||||1.29|0.27|0.196
70971070|NCT04749459|141448282|OTHER|A minimum of 10 valid results was defined as the number required to produce mean study product (or control standard) SPF with 95% confidence interval (CI) within +/- 17% of the measured mean SPF of the study product (or control standard).|||||||||||||||||CSM Classic: CIs +/- 13.7% P2 Control Standard (vs. CSM Classic) CIs +/- 16.4%|||
70971071|NCT04749459|141448282|OTHER|A minimum of 10 valid results was defined as the number required to produce mean study product (or control standard) SPF with 95% confidence interval (CI) within +/- 17% of the measured mean SPF of the study product (or control standard).|||||||||||||||||CSM Strawberry Flavor: CIs +/- 16.6% P2 Control Standard (vs CSM Strawberry Flavour): CIs +/- 16.0%|||
70971072|NCT05098041|141448283|OTHER|Linear mixed-effects model was used for analysis. The model included treatment as a fixed effect and participant as a random effect. The point estimates and 90 percent (%) confidence intervals (CIs) for the Geometric Mean Ratio (GMR) of Cmax for Soticlestat and Rifampin versus Soticlestat alone were calculated using the exponentiation of the point estimates of the difference between treatment regimen and the corresponding 90% CIs from the analyses on the natural-log (ln)-transformed Cmax.|Geometric Mean Ratio (%)|13.15|||||TWO_SIDED|90.0|9.73|17.79|||||GMR (%) was calculated as 100\*(Soticlestat + Rifampin/Soticlestat Alone).|||17.79|9.73|
70971073|NCT05098041|141448284|OTHER|Linear mixed-effects model was used for analysis. The model included treatment as a fixed effect and participant as a random effect. The point estimates and 90% CIs for the GMR of AUC∞ for Soticlestat and Rifampin versus Soticlestat alone were calculated using the exponentiation of the point estimates of the difference between treatment regimen and the corresponding 90% CIs from the analyses on the ln-transformed AUC∞.|Geometric Mean Ratio (%)|16.42|||||TWO_SIDED|90.0|12.53|21.5|||||GMR (%) was calculated as 100\*(Soticlestat + Rifampin/Soticlestat Alone).|||21.50|12.53|
70971074|NCT05098041|141448285|OTHER|Linear mixed-effects model was used for analysis. The model included treatment as a fixed effect and participant as a random effect. The point estimates and 90% CIs for the GMR of AUClast for Soticlestat and Rifampin versus Soticlestat alone were calculated using the exponentiation of the point estimates of the difference between treatment regimen and the corresponding 90% CIs from the analyses on the ln-transformed AUClast.|Geometric Mean Ratio (%)|14.92|||||TWO_SIDED|90.0|11.94|18.64|||||GMR (%) was calculated as 100\*(Soticlestat + Rifampin/Soticlestat Alone).|||18.64|11.94|
70971075|NCT05098041|141448286|OTHER||Median Difference (Final Values)|-0.117|||=|0.0791|TWO_SIDED|90.0|-0.202|0.0|||Wilcoxon Signed-Rank Test||Difference was calculated as (Soticlestat + Rifampin) - Soticlestat Alone. The difference of medians (treatment effect) and the corresponding 90% CI was estimated using the Hodges-Lehmann method and Walsh Averages.|||0.000|-0.202|=0.07910
70971076|NCT00382993|141448301|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.63|||<|0.001||95.0|2.76|11.49|||ANOVA|||||11.49|2.76|<0.001
70971077|NCT02970292|141448344|SUPERIORITY||Difference in MMRM LSMs|-2.1|STANDARD_ERROR_OF_MEAN|1.24||0.094|TWO_SIDED|95.0|-4.5|0.4|||mixed-effects model for repeated measure|||||0.4|-4.5|0.0940
71153960|NCT00488683|141800067|SUPERIORITY_OR_OTHER||R-square|0.19||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup Y||||
70971078|NCT00814775|141448353|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.72|TWO_SIDED|95.0|0.55|2.37|||Regression, Cox||CTrach vs. Fastrach|||2.37|0.55|0.72
70971079|NCT00814775|141448354|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.76||||0.45|TWO_SIDED|95.0|0.38|1.54|||Regression, Cox||CTrach vs. Fastrach|||1.54|0.38|0.45
70971080|NCT00513500|141448356|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|5.32||||||95.0|2.19|8.94||||||||8.94|2.19|
70971081|NCT00513500|141448357|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.23||||||95.0|0.14|0.38||||||||0.38|0.14|
70971082|NCT00513500|141448358|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.44||||||95.0|0.21|0.93||||||||0.93|0.21|
70971083|NCT00749996|141448363|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.61||||0.228|TWO_SIDED|95.0|-1.59|0.38|||t-test, 2 sided|||The null-hypothesis: Ho: Δ VAS DIAM = Δ VAS Control will be tested against the alternative hypothesis:HA: Δ VAS DIAM ≠ Δ VAS Control.Where Δ is the average decrease in VAS score (baseline - 6 months). A minimal sample size of 240 analyzable patients is required to demonstrate with 80% power a difference in back pain reduction that is significant at the 95% level, comparing DIAM and Control groups. 268 patients will be enroll to allow of up to 10% attrition.||0.38|-1.59|0.228
70971084|NCT00749996|141448364|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.36||||0.719|TWO_SIDED|95.0|-8.8|6.08|||t-test, 2 sided|||The null-hypothesis(Ho: Δ ODI DIAM = Δ ODI Control) will be tested against the alternative hypothesis (HA: Δ ODI DIAM ≠ Δ ODI Control). Δ ODI DIAM = average change in the ODI (12 months - baseline) in the DIAM treated patient group and Δ VAS Control =average change in the ODI in the Control group.||6.08|-8.80|0.719
71093268|NCT05168800|141693793|SUPERIORITY|||||||0.64|||||||Fisher Exact|||||||0.64
71153961|NCT00488683|141800067|SUPERIORITY_OR_OTHER||R-square|0.05||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup Y||||
70918636|NCT02528188|141328689|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.7799|TWO_SIDED|95.0|-0.08|0.06|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.06|-0.08|0.7799
70918637|NCT02528188|141328689|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.03||0.0061|TWO_SIDED|95.0|-0.16|-0.03|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||-0.03|-0.16|0.0061
70918638|NCT02528188|141328689|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.9718|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.10|-0.10|0.9718
70918639|NCT02528188|141328689|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.3292|TWO_SIDED|95.0|-0.14|0.05|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.05|-0.14|0.3292
70918640|NCT02528188|141328689|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.983|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.10|-0.10|0.9830
70918641|NCT02528188|141328689|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.9137|TWO_SIDED|95.0|-0.09|0.11|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.11|-0.09|0.9137
70918642|NCT02528188|141328689|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.8784|TWO_SIDED|95.0|-0.11|0.09|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.09|-0.11|0.8784
70918643|NCT02528188|141328689|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.9995|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.10|-0.10|0.9995
70918644|NCT02528188|141328689|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.6648|TWO_SIDED|95.0|-0.13|0.08|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.08|-0.13|0.6648
70918645|NCT02528188|141328689|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.728|TWO_SIDED|95.0|-0.09|0.12|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.12|-0.09|0.7280
70918646|NCT02528188|141328689|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.8856|TWO_SIDED|95.0|-0.09|0.11|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.11|-0.09|0.8856
70971085|NCT00606086|141448379|SUPERIORITY_OR_OTHER|||||||1|||||||Cochran-Mantel-Haenszel test|||||||1.000
70971086|NCT02692495|141448383|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71093269|NCT05168800|141693793|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.09|||||||Fisher Exact|||||||0.09
71093270|NCT05168800|141693794|SUPERIORITY|||||||0.13|||||||Fisher Exact|||||||0.13
71093271|NCT05168800|141693794|SUPERIORITY|||||||0.73|||||||Fisher Exact|||||||0.73
71093272|NCT05168800|141693794|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.1|||||||Fisher Exact|||||||0.10
71093273|NCT05168800|141693795|SUPERIORITY|||||||0.37|||||||Fisher Exact|||||||0.37
71093274|NCT05168800|141693795|SUPERIORITY|||||||0.45|||||||Fisher Exact|||||||0.45
71153962|NCT00488683|141800067|SUPERIORITY_OR_OTHER||R-square|0.7||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup A||||
70971087|NCT00708123|141448407|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.97||||0.0265|TWO_SIDED|95.0|0.47|7.48||No adjustment was made for multiple comparisons as primary comparisons were pre-defined.|ANOVA|The analysis included factors treatment, period and subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||7.48|0.47|0.0265
70971088|NCT00708123|141448407|SUPERIORITY_OR_OTHER||Adjusted mean difference|5.66||||0.0017|TWO_SIDED|95.0|2.15|9.18||No adjustment was made for multiple comparisons as primary comparisons were pre-defined.|ANOVA|The analysis included factors as treatment, period and subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||9.18|2.15|0.0017
70971089|NCT00708123|141448408|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|-1.69||||0.3413|TWO_SIDED|95.0|-5.19|1.8||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||1.80|-5.19|0.3413
70971090|NCT00708123|141448408|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.26|||<|0.0001|TWO_SIDED|95.0|6.76|13.76||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||13.76|6.76|<0.0001
70971091|NCT00708123|141448408|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|13.19|||<|0.0001|TWO_SIDED|95.0|9.69|16.68||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||16.68|9.69|<0.0001
70971092|NCT00708123|141448408|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.57|||<|0.0001|TWO_SIDED|95.0|5.09|12.05||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||12.05|5.09|<0.0001
70971093|NCT00708123|141448408|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.5|||<|0.0001|TWO_SIDED|95.0|8.01|14.98||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||14.98|8.01|<0.0001
70971094|NCT00708123|141448408|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.59||||0.0104|TWO_SIDED|95.0|-8.1|-1.09||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||-1.09|-8.10|0.0104
70971095|NCT00708123|141448408|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.52|||<|0.0001|TWO_SIDED|95.0|4.04|11.01||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||11.01|4.04|<0.0001
70971096|NCT00708123|141448408|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|2.93||||0.0986|TWO_SIDED|95.0|-0.55|6.41||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||6.41|-0.55|0.0986
70971097|NCT00708123|141448409|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|196.74||||0.0148|TWO_SIDED|95.0|38.89|354.6||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided at 5% significance level.||354.60|38.89|0.0148
70971098|NCT00708123|141448409|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|246.7||||0.0024|TWO_SIDED|95.0|88.3|405.1||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||405.10|88.30|0.0024
70971099|NCT00708123|141448409|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-49.96||||0.5328|TWO_SIDED|95.0|-207.62|107.71||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||107.71|-207.62|0.5328
71031801|NCT02728102|141572289|SUPERIORITY|||||||0.387||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Myeloma Progression between the lenalidomide/GM-CSF arm and lenalidomide alone arm.||||0.387
70971100|NCT00708123|141448409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-406.19|||<|0.0001|TWO_SIDED|95.0|-564.0|-248.37||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||-248.37|-564.00|<0.0001
70971101|NCT00708123|141448409|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|602.93|||<|0.0001|TWO_SIDED|95.0|445.97|759.9||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||759.90|445.97|<0.0001
70971102|NCT00708123|141448409|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|652.89|||<|0.0001|TWO_SIDED|95.0|495.05|810.72||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||810.72|495.05|<0.0001
70971103|NCT00708123|141448409|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|847.55|||<|0.0001|TWO_SIDED|95.0|690.54|1004.55||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||1004.55|690.54|<0.0001
70971104|NCT00708123|141448409|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|897.5|||<|0.0001|TWO_SIDED|95.0|739.92|1055.08||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors treatment, period and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||1055.08|739.92|<0.0001
70971105|NCT00708123|141448409|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|650.8|||<|0.0001|TWO_SIDED|95.0|493.61|808.0||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||808.00|493.61|<0.0001
70971106|NCT00708123|141448409|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|244.62||||0.0024|TWO_SIDED|95.0|87.62|401.61||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||401.61|87.62|0.0024
70971107|NCT00533442|141448438|SUPERIORITY|||||||0.01|||||||Log Rank|||Biopsy-Proven Acute Rejection of the Kidney (logrank test).||||0.01
70971108|NCT00533442|141448438|SUPERIORITY|||||||0.01|||||||Log Rank|||Biopsy-Proven Acute Rejection of the Pancreas (logrank test).||||0.01
70971109|NCT00533442|141448438|SUPERIORITY|||||||0.16|||||||Log Rank|||Death-Censored Kidney Graft Failure (logrank test).||||0.16
70971110|NCT00533442|141448438|SUPERIORITY|||||||0.12|||||||Log Rank|||Death-Censored Pancreas Graft Failure (logrank test).||||0.12
70971111|NCT00533442|141448438|SUPERIORITY|||||||0.96|||||||Log Rank|||Death-Uncensored (Kidney \& Pancreas) Graft Survival (logrank test).||||0.96
70971112|NCT00533442|141448438|SUPERIORITY||||||>|0.99||||||Patient Death (logrank test).|Log Rank|||||||>0.99
70971113|NCT00533442|141448439|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||Comparison of Mean eGFR at 12 Months Post-Transplant (t-test).||||0.21
70971114|NCT00533442|141448439|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||Comparison of Mean eGFR at 36 Months Post-Transplant (t-test).||||0.71
70971115|NCT00533442|141448439|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||Comparison of Mean eGFR at 60 Months Post-Transplant (t-test).||||0.33
70971116|NCT00533442|141448440|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||Comparison of Mean Log {C-Peptide Level} at 12 Months Post-Transplant (t-test).||||.47
70971117|NCT00533442|141448440|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||Comparison of Mean Log {C-Peptide Level} at 36 Months Post-Transplant (t-test).||||0.97
70971118|NCT00533442|141448440|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||Comparison of Mean Log {C-Peptide Level} at 60 Months Post-Transplant (t-test).||||0.75
70971119|NCT01119248|141448447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|0.62|<|0.001|TWO_SIDED|95.0|-0.48|-0.25|||t-test, 2 sided|||||-0.25|-0.48|<.001
70971120|NCT01119248|141448448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.0001|TWO_SIDED|95.0|-0.95|-0.43|||t-test, 2 sided|||pre- MRI body temperature was associated with change in body temperature after MRI by bivariate analysis. The values presented are adjusted for body surface area, type of MRI, room temperature and duration of MRI||-0.43|-0.95|0.0001
70971121|NCT01119248|141448449|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
70971122|NCT00562354|141448454|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.6|||||TWO_SIDED|95.0|0.39|0.84|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 1: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.84|0.39|
70971123|NCT00562354|141448454|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.7|||||TWO_SIDED|95.0|0.54|1.01|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 3: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.01|0.54|
70971124|NCT00562354|141448454|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.7|||||TWO_SIDED|95.0|0.5|1.11|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 4: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.11|0.50|
70971125|NCT00562354|141448454|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.6|||||TWO_SIDED|95.0|0.38|0.9|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 5: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.90|0.38|
70971126|NCT00562354|141448454|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.5|||||TWO_SIDED|95.0|0.37|0.74|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 6A: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.74|0.37|
70971127|NCT00562354|141448454|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.7|||||TWO_SIDED|95.0|0.52|1.02|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 6B: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.02|0.52|
70971128|NCT00562354|141448454|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.7|||||TWO_SIDED|95.0|0.46|0.95|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 7F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.95|0.46|
70971129|NCT00562354|141448454|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.7|||||TWO_SIDED|95.0|0.45|1.25|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 9V: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.25|0.45|
70971130|NCT00562354|141448454|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.7|||||TWO_SIDED|95.0|0.54|1.02|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 14: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.02|0.54|
71153963|NCT00488683|141800067|SUPERIORITY_OR_OTHER||R-square|0.21||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup A||||
70971131|NCT00562354|141448454|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.5|||||TWO_SIDED|95.0|0.35|0.79|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 18C: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.79|0.35|
70971132|NCT00562354|141448454|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.5|||||TWO_SIDED|95.0|0.34|0.67|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 19A: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.67|0.34|
70971133|NCT00562354|141448454|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.6|||||TWO_SIDED|95.0|0.37|0.88|||||Confidence intervals for the ratio are back transformation of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 19F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.88|0.37|
70971134|NCT00562354|141448454|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.5|||||TWO_SIDED|95.0|0.3|0.79|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 23F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.79|0.30|
71031802|NCT02728102|141572291|SUPERIORITY|||||||0.168||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of Progression-Free Survival between vaccine vs. non- vaccine arms.||||0.168
71031803|NCT02728102|141572292|SUPERIORITY|||||||0.12||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of Progression-Free Survival between the vaccine arm and lenalidomide/GM-CSF arm.||||0.120
71031804|NCT02728102|141572292|SUPERIORITY|||||||0.519||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of Progression-Free Survival between the vaccine arm and lenalidomide alone arm.||||0.519
71031805|NCT02728102|141572292|SUPERIORITY|||||||0.387||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of Progression-Free Survival between the lenalidomide/GM-CSF arm and lenalidomide alone arm.||||0.387
71031806|NCT02728102|141572293|SUPERIORITY|||||||0.563||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of overall Survival between vaccine vs. non- vaccine arms.||||0.563
71031807|NCT02728102|141572294|SUPERIORITY|||||||0.308||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of overall Survival between the vaccine arm and lenalidomide/GM-CSF arm.||||0.308
70971135|NCT00562354|141448457|SUPERIORITY_OR_OTHER||difference in proportions|-4.9|||||TWO_SIDED|95.0|-12.1|2.0||||||Serotype 1: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.0|-12.1|
70971136|NCT00562354|141448457|SUPERIORITY_OR_OTHER||difference in proportions|-3.9|||||TWO_SIDED|95.0|-11.6|3.5||||||Serotype 3: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||3.5|-11.6|
70971137|NCT00562354|141448457|SUPERIORITY_OR_OTHER||difference in proportions|-3.4|||||TWO_SIDED|95.0|-9.6|2.2||||||Serotype 4: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.2|-9.6|
70971138|NCT00562354|141448457|SUPERIORITY_OR_OTHER||difference in proportions|-5.5|||||TWO_SIDED|95.0|-13.7|2.5||||||Serotype 5: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.5|-13.7|
70971139|NCT00562354|141448457|SUPERIORITY_OR_OTHER||difference in proportions|-1.5|||||TWO_SIDED|95.0|-5.7|2.1||||||Serotype 6A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.1|-5.7|
70971140|NCT00562354|141448457|SUPERIORITY_OR_OTHER||difference in proportions|-1.6|||||TWO_SIDED|95.0|-5.9|2.1||||||Serotype 6B: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.1|-5.9|
70971141|NCT00562354|141448457|SUPERIORITY_OR_OTHER||difference in proportions|-5.3|||||TWO_SIDED|95.0|-10.8|-0.9||||||Serotype 7F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-0.9|-10.8|
70971142|NCT00562354|141448457|SUPERIORITY_OR_OTHER||difference in proportions|-0.8|||||TWO_SIDED|95.0|-8.7|6.9||||||Serotype 9V: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||6.9|-8.7|
70971143|NCT00562354|141448457|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-4.0|4.1||||||Serotype 14: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||4.1|-4.0|
70971144|NCT00562354|141448457|SUPERIORITY_OR_OTHER||difference in proportions|-2.3|||||TWO_SIDED|95.0|-7.6|2.5||||||Serotype 18C: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.5|-7.6|
70971145|NCT00562354|141448457|SUPERIORITY_OR_OTHER||difference in proportions|0.8|||||TWO_SIDED|95.0|-2.8|4.7||||||Serotype 19A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||4.7|-2.8|
70971146|NCT00562354|141448457|SUPERIORITY_OR_OTHER||difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.8|3.7||||||Serotype 19F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||3.7|-8.8|
70971147|NCT00562354|141448457|SUPERIORITY_OR_OTHER||difference in proportions|-6.2|||||TWO_SIDED|95.0|-14.1|1.5||||||Serotype 23F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||1.5|-14.1|
71153964|NCT00488683|141800067|SUPERIORITY_OR_OTHER||R-square|0.5||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup C||||
70971148|NCT00562354|141448460|SUPERIORITY_OR_OTHER||difference in proportions|-7.2|||||TWO_SIDED|95.0|-15.1|0.3||||||Serotype 1: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||0.3|-15.1|
70971149|NCT00562354|141448460|SUPERIORITY_OR_OTHER||difference in proportions|-5.4|||||TWO_SIDED|95.0|-14.5|3.5||||||Serotype 3: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||3.5|-14.5|
70971150|NCT00562354|141448460|SUPERIORITY_OR_OTHER||difference in proportions|-11.2|||||TWO_SIDED|95.0|-21.4|-1.0||||||Serotype 4: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-1.0|-21.4|
70971151|NCT00562354|141448460|SUPERIORITY_OR_OTHER||difference in proportions|-4.7|||||TWO_SIDED|95.0|-13.5|3.9||||||Serotype 5: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||3.9|-13.5|
70971152|NCT00562354|141448460|SUPERIORITY_OR_OTHER||difference in proportions|-5.1|||||TWO_SIDED|95.0|-14.3|4.0||||||Serotype 6A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||4.0|-14.3|
70971153|NCT00562354|141448460|SUPERIORITY_OR_OTHER||difference in proportions|-12.9|||||TWO_SIDED|95.0|-24.6|-0.8||||||Serotype 6B: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-0.8|-24.6|
70971154|NCT00562354|141448460|SUPERIORITY_OR_OTHER||difference in proportions|-7.3|||||TWO_SIDED|95.0|-16.3|1.5||||||Serotype 7F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||1.5|-16.3|
70971155|NCT00562354|141448460|SUPERIORITY_OR_OTHER||difference in proportions|-17.5|||||TWO_SIDED|95.0|-29.5|-5.0||||||Serotype 9V: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-5.0|-29.5|
70971156|NCT00562354|141448460|SUPERIORITY_OR_OTHER||difference in proportions|-9.6|||||TWO_SIDED|95.0|-21.4|2.4||||||Serotype 14: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.4|-21.4|
70971157|NCT00562354|141448460|SUPERIORITY_OR_OTHER||difference in proportions|-10.5|||||TWO_SIDED|95.0|-19.3|-1.3||||||Serotype 18C: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-1.3|-19.3|
70971158|NCT00562354|141448460|SUPERIORITY_OR_OTHER||difference in proportions|0.8|||||TWO_SIDED|95.0|-6.2|7.9||||||Serotype 19A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||7.9|-6.2|
70971159|NCT00562354|141448460|SUPERIORITY_OR_OTHER||difference in proportions|-3.8|||||TWO_SIDED|95.0|-12.2|4.5||||||Serotype 19F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||4.5|-12.2|
70971160|NCT00562354|141448460|SUPERIORITY_OR_OTHER||difference in proportions|-2.5|||||TWO_SIDED|95.0|-12.5|7.3||||||Serotype 23F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||7.3|-12.5|
70971161|NCT00562354|141448463|SUPERIORITY_OR_OTHER||difference in proportions|-5.7|||||TWO_SIDED|95.0|-13.8|2.1||||||Serotype 1: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.1|-13.8|
70971162|NCT00562354|141448463|SUPERIORITY_OR_OTHER||difference in proportions|-5.5|||||TWO_SIDED|95.0|-15.9|5.0||||||Serotype 3: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||5.0|-15.9|
70971163|NCT00562354|141448463|SUPERIORITY_OR_OTHER||difference in proportions|-18.3|||||TWO_SIDED|95.0|-30.1|-5.9||||||Serotype 4: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-5.9|-30.1|
70971164|NCT00562354|141448463|SUPERIORITY_OR_OTHER||difference in proportions|-2.3|||||TWO_SIDED|95.0|-11.6|6.9||||||Serotype 5: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||6.9|-11.6|
70971165|NCT00562354|141448463|SUPERIORITY_OR_OTHER||difference in proportions|-11.9|||||TWO_SIDED|95.0|-22.6|-1.2||||||Serotype 6A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-1.2|-22.6|
70971166|NCT00562354|141448463|SUPERIORITY_OR_OTHER||difference in proportions|-11.0|||||TWO_SIDED|95.0|-23.8|1.9||||||Serotype 6B: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||1.9|-23.8|
70971167|NCT00562354|141448463|SUPERIORITY_OR_OTHER||difference in proportions|-9.5|||||TWO_SIDED|95.0|-19.3|0.4||||||Serotype 7F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||0.4|-19.3|
71093275|NCT05168800|141693795|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.88|||||||Fisher Exact|||||||0.88
70971168|NCT00562354|141448463|SUPERIORITY_OR_OTHER||difference in proportions|-26.9|||||TWO_SIDED|95.0|-39.0|-14.1||||||Serotype 9V: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-14.1|-39.0|
70971169|NCT00562354|141448463|SUPERIORITY_OR_OTHER||difference in proportions|-6.4|||||TWO_SIDED|95.0|-18.7|6.1||||||Serotype 14: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||6.1|-18.7|
70971170|NCT00562354|141448463|SUPERIORITY_OR_OTHER||difference in proportions|-12.2|||||TWO_SIDED|95.0|-22.6|-1.7||||||Serotype 18C: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-1.7|-22.6|
70971171|NCT00562354|141448463|SUPERIORITY_OR_OTHER||difference in proportions|-0.8|||||TWO_SIDED|95.0|-9.8|8.1||||||Serotype 19A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||8.1|-9.8|
71153965|NCT00488683|141800067|SUPERIORITY_OR_OTHER||R-square|0.16||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup C||||
70971172|NCT00562354|141448463|SUPERIORITY_OR_OTHER||difference in proportions|-11.4|||||TWO_SIDED|95.0|-21.7|-1.2||||||Serotype 19F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-1.2|-21.7|
70971173|NCT00562354|141448463|SUPERIORITY_OR_OTHER||difference in proportions|-7.7|||||TWO_SIDED|95.0|-18.5|3.4||||||Serotype 23F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||3.4|-18.5|
70971174|NCT00562354|141448466|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.6|||||TWO_SIDED|95.0|0.43|0.86|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 1: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.86|0.43|
71093276|NCT05168800|141693796|SUPERIORITY|||||||0.92|||||||Adjusted Wald test|||||||0.92
71093277|NCT05168800|141693796|SUPERIORITY|||||||0.97|||||||Adjusted Wald test|||||||0.97
71093278|NCT05168800|141693796|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.83|||||||Adjusted Wald test|||||||0.83
70971175|NCT00562354|141448466|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.8|||||TWO_SIDED|95.0|0.63|1.0|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 3: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.00|0.63|
70971176|NCT00562354|141448466|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.66|||||TWO_SIDED|95.0|0.48|0.91|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 4: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.91|0.48|
70971177|NCT00562354|141448466|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.65|||||TWO_SIDED|95.0|0.5|0.85|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 5: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.85|0.50|
70971178|NCT00562354|141448466|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.71|||||TWO_SIDED|95.0|0.52|0.97|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 6A: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.97|0.52|
70971179|NCT00562354|141448466|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.65|||||TWO_SIDED|95.0|0.48|0.9|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 6B: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.90|0.48|
70971180|NCT00562354|141448466|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.74|||||TWO_SIDED|95.0|0.56|0.97|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 7F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.97|0.56|
70971181|NCT00562354|141448466|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.46|||||TWO_SIDED|95.0|0.35|0.61|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 9V: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.61|0.35|
70971182|NCT00562354|141448466|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.76|||||TWO_SIDED|95.0|0.56|1.03|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 14: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.03|0.56|
70971183|NCT00562354|141448466|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.57|||||TWO_SIDED|95.0|0.43|0.74|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 18C: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.74|0.43|
70971184|NCT00562354|141448466|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.5|||||TWO_SIDED|95.0|0.38|0.66|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 19A: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.66|0.38|
70971185|NCT00562354|141448466|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.42|||||TWO_SIDED|95.0|0.29|0.6|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 19F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.60|0.29|
70971186|NCT00562354|141448466|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.59|||||TWO_SIDED|95.0|0.42|0.82|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 23F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.82|0.42|
70971187|NCT01508702|141448491|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.19|0.37|||Cochran-Mantel-Haenszel|||||0.37|0.19|<0.0001
70971188|NCT01883635|141448496|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||t-test, 2 sided|degrees of freedom=40||||||0.14
70971189|NCT01883635|141448497|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||t-test, 2 sided|degrees of freedom=40||||||0.65
70971190|NCT01883635|141448498|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||t-test, 2 sided|degrees of freedom=40||||||0.51
70971191|NCT01187953|141448499|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.|||||>|0.999|TWO_SIDED|||||Endpoint: Death|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||>0.999
71031808|NCT02728102|141572294|SUPERIORITY|||||||0.99||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of overall Survival between the vaccine arm and lenalidomide alone arm.||||0.990
70971192|NCT01187953|141448499|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.||||||0.821|TWO_SIDED|||||Endpoint: Graft Failure|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||0.821
70971193|NCT01187953|141448499|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.||||||0.9|TWO_SIDED|||||Endpoint: BPAR|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||0.900
70971194|NCT01187953|141448499|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.|||||>|0.999|TWO_SIDED|||||Endpoint: Lost to follow up|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||>0.999
70971195|NCT01187953|141448500|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.||||||0.835|TWO_SIDED|||||Endpoint: Death|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||0.835
70971196|NCT01187953|141448500|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.||||||0.548|TWO_SIDED|||||Endpoint: Graft Failure|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||0.548
70971197|NCT01187953|141448500|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.||||||0.822|TWO_SIDED|||||Endpoint: BPAR|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||0.822
70971198|NCT01187953|141448500|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.||||||0.383|TWO_SIDED|||||Endpoint: Lost to follow up|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||0.383
70971199|NCT02572752|141448501|SUPERIORITY_OR_OTHER||gMean Ratio|97.478|STANDARD_ERROR_OF_MEAN|11.57|<|0.0001|TWO_SIDED|90.0|94.545|100.502|||ANOVA||Relative bioavailability was estimated by the ratios of the gMean of nin Test treatment (T) divided by nin Reference treatment (R1 \& R2). Standard Error of the mean is actually the intra individual geometric coefficient variation (gCV).|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment (without differentiation between R1 and R2). This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. For the two 1-sided t-test procedure, the effect 'subjects within sequences' was considered to be random, whereas the other effects were considered to be fixed||100.502|94.545|<0.0001
70971200|NCT02572752|141448502|SUPERIORITY_OR_OTHER||gMean Ratio|97.004|STANDARD_ERROR_OF_MEAN|20.77|<|0.0001|TWO_SIDED|90.0|90.948|103.463|||ANOVA||Relative bioavailability was estimated by the ratios of the gMean of nin Test treatment (T) divided by nin Reference treatment (R1 \& R2). Standard Error of the mean is actually the intra individual geometric coefficient variation (gCV).|An ANOVA model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment (without differentiation between R1 and R2). This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. For the two 1-sided t-test procedure, the effect 'subjects within sequences' was considered to be random, whereas the other effects were considered to be fixed.||103.463|90.948|<0.0001
70971201|NCT02572752|141448503|SUPERIORITY_OR_OTHER||gMean Ratio|97.149|STANDARD_DEVIATION|11.4|<|0.0001|TWO_SIDED|90.0|94.223|100.166|||ANOVA||Relative bioavailability was estimated by the ratios of the gMean of nin Test treatment (T) divided by nin Reference treatment (R1 \& R2). Standard Error of the mean is actually the intra individual geometric coefficient variation (gCV).|An ANOVA model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment (without differentiation between R1 and R2). This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. For the two 1-sided t-test procedure, the effect 'subjects within sequences' was considered to be random, whereas the other effects were considered to be fixed||100.166|94.223|<0.0001
70971202|NCT01464307|141448504|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.0||||0.777|TWO_SIDED|95.0|-0.1|0.2|||Mixed-Model Repeated Measures|||The number of subjects included in the MMRM analysis was only 286 because a covariate was missing for 3 subjects.||0.2|-0.1|0.777
71093279|NCT05168800|141693797|SUPERIORITY|||||||0.88|||||||Adjusted Wald test|||||||0.88
71093280|NCT05168800|141693797|SUPERIORITY|||||||0.49|||||||Adjusted Wald test|||||||0.49
71093281|NCT05168800|141693797|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.23|||||||Adjusted Wald test|||||||0.23
70918647|NCT02528188|141328689|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.05||0.2814|TWO_SIDED|95.0|-0.05|0.16|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.16|-0.05|0.2814
71093282|NCT05168800|141693798|SUPERIORITY|||||||0.9|||||||Adjusted Wald test|||||||0.90
71153966|NCT00488683|141800067|SUPERIORITY_OR_OTHER||R-square|1.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup W-135||||
70918648|NCT02528188|141328691|SUPERIORITY||Odds Ratio (OR)|1.07||||0.4691|TWO_SIDED|95.0|0.89|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2||1.28|0.89|0.4691
70918649|NCT02528188|141328691|SUPERIORITY||Odds Ratio (OR)|0.95||||0.5451|TWO_SIDED|95.0|0.79|1.13|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2||1.13|0.79|0.5451
70918650|NCT02528188|141328691|SUPERIORITY||Odds Ratio (OR)|1.29||||0.0059|TWO_SIDED|95.0|1.08|1.54|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4||1.54|1.08|0.0059
70918651|NCT02528188|141328691|SUPERIORITY||Odds Ratio (OR)|1.29||||0.0057|TWO_SIDED|95.0|1.08|1.55|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4||1.55|1.08|0.0057
70918652|NCT02528188|141328691|SUPERIORITY||Odds Ratio (OR)|1.14||||0.1584|TWO_SIDED|95.0|0.95|1.38|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8||1.38|0.95|0.1584
70918653|NCT02528188|141328691|SUPERIORITY||Odds Ratio (OR)|1.3||||0.006||95.0|1.08|1.58|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8||1.58|1.08|0.0060
70918654|NCT02528188|141328691|SUPERIORITY||Odds Ratio (OR)|1.18||||0.1117|TWO_SIDED|95.0|0.96|1.46|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16||1.46|0.96|0.1117
70918655|NCT02528188|141328691|SUPERIORITY||Odds Ratio (OR)|1.19||||0.1004|TWO_SIDED|95.0|0.97|1.47|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16||1.47|0.97|0.1004
70971203|NCT01464307|141448505|SUPERIORITY_OR_OTHER|||||||0.804||||||worst-case analysis.|Wilcoxon's Rank-Sum Test|||The statistical analysis provided was for all categories of this outcome measure.||||0.804
70971204|NCT01464307|141448506|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.845|TWO_SIDED|95.0|0.63|1.74||observed cases analysis.|Regression, Logistic|||Week 4. Number of subjects included in analysis was three less than the observed cases because of a missing covariate for the logistic regression analysis, that is, n=283 for week 4.||1.74|0.63|0.845
70971205|NCT01464307|141448506|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.437|TWO_SIDED|95.0|0.73|2.04||observed cases analysis.|Regression, Logistic|||Week 8. Number of subjects included in analysis was three less than the observed cases because of a missing covariate for the logistic regression analysis, that is, n=279 for week 8.||2.04|0.73|0.437
70971206|NCT01464307|141448506|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.698|TWO_SIDED|95.0|0.59|2.21||observed cases analysis.|Regression, Logistic|||Week 12. Number of subjects included in analysis was three less than the observed cases because of a missing covariate for the logistic regression analysis, that is, n=273 for week 12.||2.21|0.59|0.698
70918656|NCT02528188|141328691|SUPERIORITY||Odds Ratio (OR)|1.05||||0.6258|TWO_SIDED|95.0|0.87|1.25|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24||1.25|0.87|0.6258
70971207|NCT02997904|141448515|SUPERIORITY||Least Squares Mean Difference|1.0058|STANDARD_ERROR_OF_MEAN|0.2131|<|0.0001|TWO_SIDED|95.0|0.5829|1.4288|||ANOVA|||Ho: Total Number of lice and eggs removed with Resultz® ≤ Total number of lice and eggs removed with sham control Ha: Total Number of lice and eggs removed with Resultz® \> Total Number of lice and eggs removed with sham control||1.4288|0.5829|<0.0001
70971208|NCT02997904|141448516|SUPERIORITY||Least Squares Mean Difference|1.2084|STANDARD_ERROR_OF_MEAN|0.0467|<|0.0001|TWO_SIDED|95.0|1.1157|1.3011||The P-Values were \<0.0001 in both comparison groups; total number lice removed and total number of eggs removed|GLIMMX|||Comparison of total number of lice removed and total number of eggs removed were analyzed separately||1.3011|1.1157|<0.0001
70971209|NCT02997904|141448516|SUPERIORITY||Least Squares Mean Difference|0.7899|STANDARD_ERROR_OF_MEAN|0.04565|<|0.0001|TWO_SIDED|95.0|0.6993|0.8805|||GLIMMX|||||0.8805|0.6993|<0.0001
71093283|NCT05168800|141693798|SUPERIORITY|||||||0.94|||||||Adjusted Wald test|||||||0.94
71093284|NCT05168800|141693798|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.86|||||||Adjusted Wald test|||||||0.86
71093285|NCT05168800|141693799|SUPERIORITY|||||||1|||||||Two-sample z test|||||||1.00
71093286|NCT05168800|141693799|SUPERIORITY|||||||1|||||||Two-sample z test|||||||1.0
71093287|NCT05168800|141693799|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.49|||||||Two-sample z test|||||||0.49
71093288|NCT05168800|141693800|SUPERIORITY|||||||0.88|||||||Two-sample z test|||||||0.88
70971210|NCT00159861|141448536|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier estimate|0.095|||||TWO_SIDED|95.0|0.059|0.132||||||1 Year: Proportion of participants who died.||0.132|0.059|
70971211|NCT00159861|141448536|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier estimate|0.194|||||TWO_SIDED|95.0|0.144|0.243||||||2 Years: Proportion of participants who died.||0.243|0.144|
70971212|NCT00159861|141448536|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier estimate|0.26|||||TWO_SIDED|95.0|0.205|0.315||||||3 Years: Proportion of participants who died.||0.315|0.205|
70971213|NCT00159861|141448536|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier estimate|0.291|||||TWO_SIDED|95.0|0.234|0.348||||||4 Years: Proportion of participants who died.||0.348|0.234|
70971214|NCT00159861|141448536|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier estimate|0.369|||||TWO_SIDED|95.0|0.302|0.437||||||5 Years: Proportion of participants who died.||0.437|0.302|
70971215|NCT00631748|141448546|SUPERIORITY_OR_OTHER||||||<|0.25|TWO_SIDED|95.0|||||ANCOVA|We compared TLFB at baseline and at end of study.||We used a repeated-measures ANCOVA to compare cocaine usage between the two groups. This incorporated the multiple administrations of the Timeline Followback measure.||||<0.25
70971216|NCT00631748|141448547|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Regression, Cox|||End-of-trial abstinence was defined as a negative urine drug screen (for cocaine) for three consecutive weeks at the end of the study.||||.65
70971217|NCT00623480|141448623|SUPERIORITY_OR_OTHER||Ratio (On-Demand vs. Prophylaxis)|14.7|||<|0.0001|TWO_SIDED|95.0|8.1|26.5|||Negative Binomial Regression Model|Adjusted for time of follow-up||||26.5|8.1|<0.0001
70971218|NCT00623480|141448624|SUPERIORITY_OR_OTHER||estimated diff (prohylaxis vs. OD)|-0.17||||0.6614|TWO_SIDED|95.0|-0.92|0.59|||Based on cLDA model|Adjusted for presence/absence of target joint and prior 6 month bleeding frequency||||0.59|-0.92|0.6614
70971219|NCT00623480|141448625|SUPERIORITY_OR_OTHER||estimated diff (prohylaxis vs. OD)|-0.94||||0.0072|TWO_SIDED|95.0|-1.61|-0.26|||Based on cLDA model|Adjusted for presence/absence of target joint and prior 6 month bleeding frequency||||-0.26|-1.61|0.0072
70971220|NCT00623480|141448626|SUPERIORITY_OR_OTHER||estimated diff (prohylaxis vs. OD)|13.15|||||TWO_SIDED|95.0|5.23|21.08||no p-values computed|Based on cLDA model|Adjusted for presence/absence of target joint and prior 6 month bleeding frequency||||21.08|5.23|
70971221|NCT01877187|141448628|OTHER|||||||0.06||||||Statistical significance defined as p \<= .05. Result is for Day 30 timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||.06
70971222|NCT01877187|141448628|OTHER|||||||0.09||||||Statistical significance defined as p \<= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||.09
70971223|NCT01877187|141448628|OTHER|||||||0.034||||||Statistical significance defined as p \<= 0.05. Data for 180 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.034
70971224|NCT01877187|141448630|OTHER|||||||0.19||||||Statistical significance defined as p \<= 0.05. Data for 30 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.19
70971225|NCT01877187|141448630|OTHER|||||||0.011||||||Statistical significance defined as p \<= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.011
70971226|NCT01877187|141448630|OTHER|||||||0.94||||||Statistical significance defined as p \<= 0.05. Data for 180 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.94
70971227|NCT01877187|141448632|OTHER|||||||0.06||||||Statistical significance defined as p \<= 0.05. Data for 30 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.06
70971228|NCT01877187|141448632|OTHER|||||||0.017||||||Statistical significance defined as p \<= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.017
70971229|NCT01877187|141448632|OTHER|||||||0.08||||||Statistical significance defined as p \<= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.08
70971230|NCT01877187|141448634|OTHER|||||||0.02||||||Statistical significance defined as p \<= 0.05. Data for 30 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.020
70971231|NCT01877187|141448634|OTHER|||||||0.029||||||Statistical significance defined as p \<= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.029
70971232|NCT01877187|141448634|OTHER|||||||0.94||||||Statistical significance defined as p \<= 0.05. Data for 180 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.94
71093289|NCT05168800|141693800|SUPERIORITY|||||||1|||||||Two-sample z test|||||||1.00
71093290|NCT05168800|141693800|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.02|||||||Two-sample z test|||||||0.02
71093291|NCT05168800|141693801|SUPERIORITY|||||||0.82|||||||Two-sample z test|||||||0.82
70918657|NCT02528188|141328691|SUPERIORITY||Odds Ratio (OR)|1.16||||0.1154|TWO_SIDED|95.0|0.96|1.39|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24||1.39|0.96|0.1154
70918658|NCT02528188|141328691|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8018|TWO_SIDED|95.0|0.86|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32||1.22|0.86|0.8018
70918659|NCT02528188|141328691|SUPERIORITY||Odds Ratio (OR)|1.05||||0.5697|TWO_SIDED|95.0|0.88|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32||1.26|0.88|0.5697
70918660|NCT02528188|141328691|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9557|TWO_SIDED|95.0|0.84|1.2|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40||1.20|0.84|0.9557
70918661|NCT02528188|141328691|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8553|TWO_SIDED|95.0|0.85|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40||1.22|0.85|0.8553
70918662|NCT02528188|141328691|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9901|TWO_SIDED|95.0|0.84|1.2|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48||1.20|0.84|0.9901
70918663|NCT02528188|141328691|SUPERIORITY||Odds Ratio (OR)|0.95||||0.587|TWO_SIDED|95.0|0.8|1.14|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48||1.14|0.80|0.5870
70918664|NCT02528188|141328691|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8302|TWO_SIDED|95.0|0.85|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56||1.22|0.85|0.8302
70918665|NCT02528188|141328691|SUPERIORITY||Odds Ratio (OR)|0.94||||0.4823|TWO_SIDED|95.0|0.79|1.12|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56||1.12|0.79|0.4823
70918666|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.11||||0.2938|TWO_SIDED|95.0|0.92|1.33|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=30% reduction||1.33|0.92|0.2938
70918667|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|0.91||||0.3146|TWO_SIDED|95.0|0.75|1.1|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=30% reduction||1.10|0.75|0.3146
71153967|NCT00488683|141800067|SUPERIORITY_OR_OTHER||R-square|0.3||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup W-135||||
70918668|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.24||||0.0748|TWO_SIDED|95.0|0.98|1.58|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=50% reduction||1.58|0.98|0.0748
70918669|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.14||||0.3|TWO_SIDED|95.0|0.89|1.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=50% reduction||1.45|0.89|0.3000
70918670|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.23||||0.255|TWO_SIDED|95.0|0.86|1.74|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=70% reduction||1.74|0.86|0.2550
70918671|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.14||||0.478|TWO_SIDED|95.0|0.8|1.62|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=70% reduction||1.62|0.80|0.4780
70918672|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.3||||0.4006|TWO_SIDED|95.0|0.7|2.42|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=90% reduction||2.42|0.70|0.4006
70918673|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.38||||0.3089|TWO_SIDED|95.0|0.74|2.54|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=90% reduction||2.54|0.74|0.3089
71093292|NCT05168800|141693801|SUPERIORITY|||||||0.97|||||||Two-sample z test|||||||0.97
71093293|NCT05168800|141693801|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.18|||||||Two-sample z test|||||||0.18
70971233|NCT01877187|141448636|OTHER|||||||0.06||||||Statistical significance defined as p \<= 0.05. Data for 30 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.06
70971234|NCT01877187|141448636|OTHER|||||||0.013||||||Statistical significance defined as p \<= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.013
70971235|NCT01877187|141448636|OTHER|||||||0.67||||||Statistical significance defined as p \<= 0.05. Data for 180 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.67
70971236|NCT03716869|141448651|SUPERIORITY||Odds Ratio (OR)|2.07|||<|0.001|TWO_SIDED|95.0|1.39|3.1|||Regression, Logistic|||Statistical analysis was conducted using the intent-to-treat principle. Analysis for primary and secondary outcomes that compared universal to targeted screening was conducted using mixed effects logistic regression.||3.10|1.39|<0.001
70971237|NCT03716869|141448652|SUPERIORITY||Odds Ratio (OR)|5.92|||<|0.001|TWO_SIDED|95.0|5.07|6.93|||Regression, Logistic|||||6.93|5.07|<0.001
70971238|NCT03716869|141448654|SUPERIORITY||Odds Ratio (OR)|3.3|||<|0.001|TWO_SIDED|95.0|2.49|4.38|||Regression, Logistic|||||4.38|2.49|<0.001
70971239|NCT03716869|141448660|SUPERIORITY||Odds Ratio (OR)|8.42|||<|0.001|TWO_SIDED|95.0|6.71|10.58|||Regression, Logistic||Test of interaction terms from mixed-effects logistic regression for subgroup analyses. Information above is sex x rand group interaction for identification of MDD symptoms among females. For males, OR 4.05 (95% CI 3.26-5.03).||"Sex x rand group interaction p=0.005 for SAP confirmation of need for follow-up.~Females 4.73 (3.19-7.02) Males 2.09 (1.38-3.16)~Sex x rand group interaction p=0.37 for treatment initiation. OR is not reported due to p\>0.05."|10.58|6.71|<0.001
70971240|NCT03716869|141448660|SUPERIORITY||Odds Ratio (OR)|8.65|||<|0.001|TWO_SIDED|95.0|6.58|11.35|||Regression, Logistic||Information above is for race/ethnicity x rand group interaction for identification of MDD symptoms for non-Hispanic white students. For non-Hispanic Black students OR 2.55 (95% CI 1.97-3.31), Hispanic 7.45 (4.98-11.17), other 12.41 (7.34-21.00).||"Race/ethnicity x rand group p=0.007 for SAP confirmation of need for follow-up. non-Hispanic white 2.24 (1.59-3.15) non-Hispanic Black 4.19 (2.03-8.65) Hispanic 10.15 (4.06-25.36) Other 12.22 (1.59-94.12)~Race/ethnicity x rand group interaction p=0.15 for treatment initiation. OR is not reported due to p\>0.05."|11.35|6.58|<0.001
70971241|NCT03716869|141448660|SUPERIORITY||Odds Ratio (OR)|5.47||||0.006|TWO_SIDED|95.0|4.65|6.44|||Regression, Logistic||Information above is location x rand group interaction for identification of MDD symptoms among urban students. For rural students and identification of depressive symptoms OR 13.60 (95% CI 7.28-25.42).||"Location x rand group interaction p=0.27 for SAP confirmation of need for follow-up. OR is not reported due to p\>0.05.~Location x rand group interaction p=0.36 for treatment initiation. OR is not reported due to p\>0.05."|6.44|4.65|0.006
70971242|NCT01789814|141448663|SUPERIORITY_OR_OTHER|||||||0.001||||||Prasugrel treatment when compared to Clopidogrel was associated with significant reduction in platelets aggregation for all plateles agonist (ADD, SFFFLRN, AYPGKF) at all measured time points.|t-test, 2 sided|||Each patient will have paired samples representing their baseline as well as an on-drug sample. The magnitude of platelet inhibition for each studied agonist will be performed utilizing mean maximal change from baseline in light transmission aggregometry. The paired samples will be analyzed using a two-tailed student's t-test. Statistical significance will be assumed to occur when p\<0.05.||||0.001
70971243|NCT01289015|141448693|SUPERIORITY_OR_OTHER||p-value|0.001|||<|0.025||95.0|||||Cochran-Mantel-Haenszel|The CMH test statistic after stratification was used to compare subjects with complete cure between NAFT-600 and placebo.||"In order to compare complete cure rate in the NAFT-600 group with that of the placebo group, the following one-sided hypothesis test was carried out:~H0 (null): p1\<=p0 versus Ha (alternate): p1\>p0, where p0 and p1 are the proportions of subjects with complete cure in the proportions of subjects with complete cure in the placebo and NAFT-600 treatment groups respectively."||||<0.025
70971244|NCT00428974|141448695|SUPERIORITY|||||||0.031|||||||t-test, 1 sided|||12 weeks, 2mg CF101 vs. Placebo||||0.031
70971245|NCT00428974|141448696|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||||||<0.05
70971246|NCT02797808|141448698|SUPERIORITY||||||<|0.0083||||||Independent-sample t tests were used to compare the RSFC metrics between groups at baseline and 12 weeks. Bonferroni correction was applied to the alpha level (2-tailed, p\<.05/6= .0083) for multiple testing.|ANOVA|||||||<0.0083
70971247|NCT01425203|141448718|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Percentages|29.2|||<|0.0001|TWO_SIDED|95.0|16.4|41.5||Multiplicity adjustment for controlling type 1 error for the primary comparison was based on the step-down approach.|Miettinen and Nurminen Method||The difference, 95% CI and p-value are adjusted by stratification factors of IL-28B genotype and previous treatment, based on the Miettinen \& Nurminen method.|The primary statistical comparison was conducted on the FAS using the stratified Miettinen and Nurminen method at alpha level of 0.050 adjusted for stratification factors, including IL28B genotype and previous treatment as specified at the time of randomization.||41.5|16.4|<0.0001
70971248|NCT01425203|141448719|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Percentages|30.2|||<|0.0001|TWO_SIDED|95.0|17.3|42.5||Multiplicity adjustment for controlling type 1 error for key secondary comparison based on a step-down approach. Key-secondary comparison was tested only if statistical significance of primary comparison was met at alpha level of 0.050.|Miettinen and Nurminen Method||The difference, 95% CI and p-value are adjusted by stratification factors of IL-28B genotype and previous treatment, based on the Miettinen \& Nurminen method.|The key secondary statistical comparison was conducted on the mITT using the stratified Miettinen and Nurminen method at alpha level of 0.050 adjusted for stratification factors.||42.5|17.3|<0.0001
71153968|NCT00488683|141800067|SUPERIORITY_OR_OTHER||R-square|0.21||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup Y||||
70918674|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.26||||0.0114|TWO_SIDED|95.0|1.05|1.5|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=30% reduction||1.50|1.05|0.0114
70918675|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.23||||0.0239|TWO_SIDED|95.0|1.03|1.47|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=30% reduction||1.47|1.03|0.0239
70918676|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.31||||0.0079|TWO_SIDED|95.0|1.07|1.6|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=50% reduction||1.60|1.07|0.0079
70918677|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.32||||0.0068|TWO_SIDED|95.0|1.08|1.6|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=50% reduction||1.60|1.08|0.0068
70918678|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.24||||0.1037|TWO_SIDED|95.0|0.96|1.62|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=70% reduction||1.62|0.96|0.1037
70918679|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0046|TWO_SIDED|95.0|1.12|1.88|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=70% reduction||1.88|1.12|0.0046
70918680|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.36||||0.1971|TWO_SIDED|95.0|0.85|2.19|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=90% reduction||2.19|0.85|0.1971
70918681|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.59||||0.048|TWO_SIDED|95.0|1.0|2.52|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=90% reduction||2.52|1.00|0.0480
70918682|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.07||||0.4744|TWO_SIDED|95.0|0.89|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=30% reduction||1.28|0.89|0.4744
70918683|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.21||||0.0336|TWO_SIDED|95.0|1.02|1.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=30% reduction||1.45|1.02|0.0336
70918684|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.2||||0.0559|TWO_SIDED|95.0|1.0|1.44|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=50% reduction||1.44|1.00|0.0559
70918685|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.34||||0.0021|TWO_SIDED|95.0|1.11|1.61|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=50% reduction||1.61|1.11|0.0021
70918686|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.26||||0.0535|TWO_SIDED|95.0|1.0|1.59|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=70% reduction||1.59|1.00|0.0535
70918687|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.53||||0.0003|TWO_SIDED|95.0|1.22|1.92|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=70% reduction||1.92|1.22|0.0003
70918688|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.11||||0.6421|TWO_SIDED|95.0|0.72|1.7|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=90% reduction||1.70|0.72|0.6421
70918689|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0207|TWO_SIDED|95.0|1.07|2.38|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=90% reduction||2.38|1.07|0.0207
70918690|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.15||||0.1635|TWO_SIDED|95.0|0.95|1.39|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=30% reduction||1.39|0.95|0.1635
70918691|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.21||||0.0529|TWO_SIDED|95.0|1.0|1.47|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=30% reduction||1.47|1.00|0.0529
70918692|NCT02528188|141328692|SUPERIORITY|The two key secondary comparisons for 'Participants with \>=50% reduction from baseline in WOMAC Pain at Week 16' (tanezumab 2.5 mg treatment group versus NSAID and tanezumab 5 mg treatment group versus NSAID) could not be considered significant since preceding tests in the graphical testing procedure were not significant.|Odds Ratio (OR)|1.15||||0.1322|TWO_SIDED|95.0|0.96|1.37|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=50% reduction||1.37|0.96|0.1322
70918693|NCT02528188|141328692|SUPERIORITY|The two key secondary comparisons for 'Participants with \>=50% reduction from baseline in WOMAC Pain at Week 16' (tanezumab 2.5 mg treatment group versus NSAID and tanezumab 5 mg treatment group versus NSAID) could not be considered significant since preceding tests in the graphical testing procedure were not significant.|Odds Ratio (OR)|1.22||||0.0262|TWO_SIDED|95.0|1.02|1.46|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=50% reduction||1.46|1.02|0.0262
70918694|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9805|TWO_SIDED|95.0|0.83|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=70% reduction||1.22|0.83|0.9805
70918695|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.33||||0.0033|TWO_SIDED|95.0|1.1|1.61|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=70% reduction||1.61|1.10|0.0033
70918696|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.24||||0.159|TWO_SIDED|95.0|0.92|1.69|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=90% reduction||1.69|0.92|0.1590
70918697|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.57||||0.0024|TWO_SIDED|95.0|1.17|2.11|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=90% reduction||2.11|1.17|0.0024
70918698|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9932|TWO_SIDED|95.0|0.83|1.2|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=30% reduction||1.20|0.83|0.9932
70918699|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.07||||0.4374|TWO_SIDED|95.0|0.9|1.29|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=30% reduction||1.29|0.90|0.4374
70918700|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.07||||0.4406|TWO_SIDED|95.0|0.9|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=50% reduction||1.28|0.90|0.4406
70918701|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.08||||0.4078|TWO_SIDED|95.0|0.9|1.29|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=50% reduction||1.29|0.90|0.4078
70918702|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.08||||0.4071|TWO_SIDED|95.0|0.89|1.31|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=70% reduction||1.31|0.89|0.4071
70918703|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.24||||0.0248|TWO_SIDED|95.0|1.03|1.5|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=70% reduction||1.50|1.03|0.0248
70918704|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|0.88||||0.3641|TWO_SIDED|95.0|0.66|1.16|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=90% reduction||1.16|0.66|0.3641
70918705|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.17||||0.2497|TWO_SIDED|95.0|0.89|1.53|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=90% reduction||1.53|0.89|0.2497
70918706|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8682|TWO_SIDED|95.0|0.85|1.21|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=30% reduction||1.21|0.85|0.8682
70918707|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|0.97||||0.7317|TWO_SIDED|95.0|0.81|1.16|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=30% reduction||1.16|0.81|0.7317
71153969|NCT00488683|141800067|SUPERIORITY_OR_OTHER||R-square|0.12||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup Y||||
71093294|NCT02629159|141693829|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|Response Rate Difference|34.1|||<|0.001|TWO_SIDED|95.0|29.0|39.2||This comparison was the primary analysis for US/FDA regulatory purposes, and a ranked key secondary endpoint for EU/EMA regulatory purposes.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo|||39.2|29.0|<0.001
71093295|NCT02629159|141693829|SUPERIORITY||Response Rate Difference|7.5||||0.018|TWO_SIDED|95.0|1.2|13.8||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Adalimumab|||13.8|1.2|0.018
71093296|NCT02629159|141693830|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|Response Rate Difference|22.6|||<|0.001|TWO_SIDED|95.0|18.6|26.5||This comparison was the primary analysis for EU/EMA regulatory purposes, and a ranked key secondary endpoint for US/FDA regulatory purposes.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo|||26.5|18.6|<0.001
70971249|NCT01425203|141448720|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Percentages|45.6|||<|0.0001|TWO_SIDED|95.0|33.2|57.0|||Miettinen and Nurminen Method||The difference, 95% CI and p-value are adjusted by stratification factors of IL-28B genotype and previous treatment, based on the Miettinen \& Nurminen method.|The percentage of participants achieving EVR at TW8 was compared using the stratified Miettinen and Nurminen method at alpha level of 0.050 adjusted for stratification factors in the FAS population.||57.0|33.2|<0.0001
71093297|NCT02629159|141693830|SUPERIORITY||Response Rate Difference|10.7|||<|0.001|TWO_SIDED|95.0|5.3|16.1||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Adalimumab|||16.1|5.3|<0.001
70971250|NCT00535132|141448725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_DEVIATION|1.4|<|0.001||||||p-value based on a paired t-test for a within-group comparison.|t-test, 2 sided|||Sample size for this study was based on changes in the MSQ scores within subjects from baseline to endpoint using a one-sample paired t-test. A sample size of 97 subjects was shown to have 90% power at endpoint to detect a mean change from baseline of 0.5 units on the MSQ score, with a standard deviation of 1.5. Allowing for extra variability from subjects with prior generic risperidone (instead of branded risperidone) use, this number was increased to 150 subjects.||||<0.001
70971251|NCT00535132|141448726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8|STANDARD_DEVIATION|1.4|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
70971252|NCT00535132|141448727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_DEVIATION|1.4|<|0.001|||||||t-test, 2 sided|||||||<0.001
70971253|NCT00535132|141448728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|STANDARD_DEVIATION|1.3|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
70971254|NCT00535132|141448729|SUPERIORITY_OR_OTHER|||||||0.002|||||||Fisher Exact|P-values for the study group comparisons using dichotomized categories are based on Fisher's Exact Test.||||||0.002
70971255|NCT00535132|141448730|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Fisher Exact|P-values for the study group comparisons using dichotomized categories are based on Fisher's Exact Test.||||||0.033
71093298|NCT02629159|141693831|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-1.33|||<|0.001|TWO_SIDED|95.0|-1.469|-1.194||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|ANCOVA|Analysis of covariance (ANCOVA) model with treatment, prior biological DMARD use, and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-1.194|-1.469|<0.001
70971256|NCT00535132|141448731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.9|STANDARD_DEVIATION|13.1|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
70971257|NCT00535132|141448732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_DEVIATION|0.9|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
70971258|NCT00535132|141448733|SUPERIORITY_OR_OTHER|||||||0.123||95.0||||P-values for the study group comparisons using dichotomized categories are based on Fisher's Exact Test.|Fisher Exact|||||||0.123
70971259|NCT00535132|141448734|SUPERIORITY_OR_OTHER|||||||0.125||95.0|||||Fisher Exact|P-values for the study group comparisons using dichotomized categories are based on Fisher's Exact Test.||||||0.125
70971260|NCT00535132|141448735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.3|STANDARD_DEVIATION|23.1|<|0.001||||||p-value for within-group comparison based on a paired t-test.|t-test, 2 sided|||||||<0.001
70971261|NCT00535132|141448736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|STANDARD_DEVIATION|7.5||0.009|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||0.009
70971262|NCT00535132|141448737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|STANDARD_DEVIATION|10.4|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
70971263|NCT00535132|141448738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3|STANDARD_DEVIATION|4.3|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
70971264|NCT00535132|141448739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_DEVIATION|3.0|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
70971265|NCT00983983|141448758|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Mixed Models Analysis|||Change over time in the ALSFRS-R was analyzed using random-slopes models||||0.07
70971266|NCT00983983|141448760|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Fisher Exact|||||||0.06
70971267|NCT00983983|141448761|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Fisher Exact|||||||0.0005
70971268|NCT00983983|141448762|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Fisher Exact|||||||0.03
70971269|NCT03759665|141448764|SUPERIORITY||Hodges-Lehmann Estimator|0.75||||0.044|TWO_SIDED|90.0|0.0|1.5|||1-sided Wilcoxon signed-rank test|||||1.50|0.00|0.044
70971270|NCT03759665|141448766|SUPERIORITY||Hodges-Lehmann Estimator|0.13||||0.206|TWO_SIDED|90.0|-0.13|0.25|||1-sided Wilcoxon signed-rank test|||||0.25|-0.13|0.206
70971271|NCT03759665|141448769|SUPERIORITY||Hodges-Lehmann Estimator|0.0327||||0.21|TWO_SIDED|90.0|-0.0327|0.104|||1-sided Wilcoxon signed-rank test|||Treatment With IB1001||0.1040|-0.0327|0.210
70971272|NCT03759665|141448769|SUPERIORITY||Hodges-Lehmann Estimator|-0.0291||||0.212|TWO_SIDED|90.0|-0.0863|0.0262|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||0.0262|-0.0863|0.212
71093299|NCT02629159|141693831|SUPERIORITY||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.638|-0.295||This comparison was not part of the pre-specified multiplicity testing sequence.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Adalimumab|||-0.295|-0.638|<0.001
70971273|NCT03759665|141448770|SUPERIORITY||Hodges-Lehmann Estimator|-1.25|||<|0.001|TWO_SIDED|90.0|-1.75|-0.75|||1-sided Wilcoxon signed-rank test|||Treatment With IB1001||-0.75|-1.75|<0.001
71153970|NCT00488683|141800067|SUPERIORITY_OR_OTHER||R-square|0.0015||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup A||||
70971274|NCT03759665|141448770|SUPERIORITY||Hodges-Lehmann Estimator|1.25||||0.001|TWO_SIDED|90.0|0.5|2.0|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||2.00|0.50|0.001
70971275|NCT03759665|141448772|SUPERIORITY||Hodges-Lehmann Estimator|-0.031||||0.02|TWO_SIDED|90.0|-0.063|0.0|||1-sided Wilcoxon signed-rank test|||Treatment with IB1001||0.000|-0.063|0.020
70971276|NCT03759665|141448772|SUPERIORITY||Hodges-Lehmann Estimator|0.042|||<|0.001|TWO_SIDED|90.0|0.021|0.063|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||0.063|0.021|<0.001
70971277|NCT03759665|141448773|SUPERIORITY||Hodges-Lehmann Estimator|3.0|||<|0.001|TWO_SIDED|90.0|3.0|3.5|||1-sided Wilcoxon signed-rank test|||Treatment With IB1001||3.5|3.0|<0.001
70971278|NCT03759665|141448773|SUPERIORITY||Hodges-Lehmann Estimator|5.0|||<|0.001|TWO_SIDED|90.0|4.5|5.0|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||5.0|4.5|<0.001
70971279|NCT01857869|141448777|OTHER||1-Relative Risk|86.7|||<|0.0001|TWO_SIDED|95.0|66.8|94.6||Two-sided Fisher Exact test was used for the comparison of malaria incidence after first/second CHMI between the compared groups.|Mantel Haenszel|||Vaccine efficacy (VE) was defined as 100\*(1-Relative Risk \[RR\]).||94.6|66.8|<0.0001
70971280|NCT01857869|141448777|OTHER||1-Relative Risk|62.5||||0.0009|TWO_SIDED|95.0|29.4|80.1||Two-sided Fisher Exact test was used for the comparison of malaria incidence after first/second CHMI between the compared groups.|Mantel Haenszel|||Vaccine efficacy (VE) was defined as 100\*(1-Relative Risk \[RR\]).||80.1|29.4|0.0009
70971281|NCT03988335|141448799|OTHER|The primary endpoints were first tested at alpha of 10% (2-sided). If the larger p-value was less than 10% (2-sided), both primary endpoints were to be declared statistically significant. If the larger p-value was greater than 10%, but the smaller p-value was less than 5% (2-sided), then the primary endpoint with the smaller p-value was to be declared statistically significant.||||||0.24|||||||Hochberg's method|||||||0.24
70971282|NCT03988335|141448800|OTHER|The primary endpoints were first tested at alpha of 10% (2-sided). If the larger p-value was less than 10% (2sided), both primary endpoints were to be declared statistically significant. If the larger p-value was greater than 10%, but the smaller p-value was less than 5% (2-sided), then the primary endpoint with the smaller p-value was to be declared statistically significant.||||||0.804|||||||Hochberg's method|||||||0.804
70971283|NCT03016325|141448821|SUPERIORITY|Part I, clinically relevant hypotension - relative risk|Relative risk from placebo|2.45|||||TWO_SIDED|95.0|0.83|14.53||||||||14.53|0.83|
70971284|NCT03016325|141448821|SUPERIORITY|Part I, clinically relevant hypotension - relative difference|Relative difference from placebo|0.12|||||TWO_SIDED|95.0|-0.02|0.28||||||||0.28|-0.02|
70971285|NCT03016325|141448821|SUPERIORITY|Part I, symptoms of hypotension - relative risk|Relative risk from placebo|2.94|||||TWO_SIDED|95.0|0.31|75.47||||||||75.47|0.31|
70971286|NCT03016325|141448821|SUPERIORITY|Part I, symptoms of hypotension - relative difference|Relative difference from placebo|0.04|||||TWO_SIDED|95.0|-0.06|0.15||||||||0.15|-0.06|
70971287|NCT03016325|141448821|SUPERIORITY|Part I, confirmed SBP \< 90 mmHg - relative risk|Relative risk from placebo|3.27|||||TWO_SIDED|95.0|1.01|14.66||||||||14.66|1.01|
70971288|NCT03016325|141448821|SUPERIORITY|Part I, confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.14|||||TWO_SIDED|95.0|0.0|0.29||||||||0.29|0.00|
70971289|NCT03016325|141448821|SUPERIORITY|Part II (low dose), clinically relevant hypotension - relative risk|Relative risk from placebo|1.15|||||TWO_SIDED|95.0|0.58|2.43||||||||2.43|0.58|
70971290|NCT03016325|141448821|SUPERIORITY|Part II (low dose), clinically relevant hypotension - relative difference|Relative difference from placebo|0.03|||||TWO_SIDED|95.0|-0.11|0.16||||||||0.16|-0.11|
70971291|NCT03016325|141448821|SUPERIORITY|Part II (low dose), symptoms of hypotension - relative risk|Relative risk from placebo|2.0|||||TWO_SIDED|95.0|0.18|54.35||||||||54.35|0.18|
70971292|NCT03016325|141448821|SUPERIORITY|Part II (low dose), symptoms of hypotension - relative difference|Relative difference from placebo|0.01|||||TWO_SIDED|95.0|-0.05|0.09||||||||0.09|-0.05|
70971293|NCT03016325|141448821|SUPERIORITY|Part II (low dose), confirmed SBP \< 90 mmHg - relative risk|Relative risk from placebo|1.15|||||TWO_SIDED|95.0|0.58|2.43||||||||2.43|0.58|
70971294|NCT03016325|141448821|SUPERIORITY|Part II (low dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.03|||||TWO_SIDED|95.0|-0.11|0.16||||||||0.16|-0.11|
70971295|NCT03016325|141448821|SUPERIORITY|Part II (high dose), clinically relevant hypotension - relative risk|Relative risk from placebo|1.9|||||TWO_SIDED|95.0|1.04|3.59||||||||3.59|1.04|
70971296|NCT03016325|141448821|SUPERIORITY|Part II (high dose), clinically relevant hypotension - relative difference|Relative difference from placebo|0.16|||||TWO_SIDED|95.0|0.01|0.31||||||||0.31|0.01|
70918708|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.04||||0.6493|TWO_SIDED|95.0|0.87|1.24|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=50% reduction||1.24|0.87|0.6493
71153971|NCT00488683|141800067|SUPERIORITY_OR_OTHER||R-square|0.0057||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup A||||
71153972|NCT00488683|141800067|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup C||||
70918709|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|0.98||||0.7973|TWO_SIDED|95.0|0.82|1.17|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=50% reduction||1.17|0.82|0.7973
70918710|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.19||||0.0757|TWO_SIDED|95.0|0.98|1.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=70% reduction||1.45|0.98|0.0757
70918711|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.21||||0.0578|TWO_SIDED|95.0|0.99|1.47|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=70% reduction||1.47|0.99|0.0578
70918712|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.02||||0.901|TWO_SIDED|95.0|0.76|1.37|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=90% reduction||1.37|0.76|0.9010
70918713|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.32||||0.0548|TWO_SIDED|95.0|0.99|1.74|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=90% reduction||1.74|0.99|0.0548
70918714|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7331|TWO_SIDED|95.0|0.86|1.23|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=30% reduction||1.23|0.86|0.7331
70918715|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|0.98||||0.8632|TWO_SIDED|95.0|0.82|1.18|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=30% reduction||1.18|0.82|0.8632
70918716|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.04||||0.6262|TWO_SIDED|95.0|0.88|1.25|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=50% reduction||1.25|0.88|0.6262
70918717|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|0.96||||0.6817|TWO_SIDED|95.0|0.81|1.15|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=50% reduction||1.15|0.81|0.6817
70918718|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.03||||0.799|TWO_SIDED|95.0|0.85|1.24|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=70% reduction||1.24|0.85|0.7990
70918719|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.04||||0.6786|TWO_SIDED|95.0|0.86|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=70% reduction||1.26|0.86|0.6786
70918720|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.04||||0.8069|TWO_SIDED|95.0|0.78|1.38|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=90% reduction||1.38|0.78|0.8069
70918721|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.16||||0.2951|TWO_SIDED|95.0|0.88|1.54|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=90% reduction||1.54|0.88|0.2951
70918722|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9093|TWO_SIDED|95.0|0.85|1.21|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=30% reduction||1.21|0.85|0.9093
70918723|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|0.94||||0.5032|TWO_SIDED|95.0|0.79|1.12|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=30% reduction||1.12|0.79|0.5032
70971297|NCT03016325|141448821|SUPERIORITY|Part II (high dose), symptoms of hypotension - relative risk|Relative risk from placebo|5.92|||||TWO_SIDED|95.0|0.91|149.72||||||||149.72|0.91|
70971298|NCT03016325|141448821|SUPERIORITY|Part II (high dose), symptoms of hypotension - relative difference|Relative difference from placebo|0.07|||||TWO_SIDED|95.0|-0.01|0.16||||||||0.16|-0.01|
70971299|NCT03016325|141448821|SUPERIORITY|Part II (high dose), confirmed SBP \< 90 mmHg - relative risk|Relative risk from placebo|1.59|||||TWO_SIDED|95.0|0.87|3.21||||||||3.21|0.87|
70971300|NCT03016325|141448821|SUPERIORITY|Part II (high dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.11|||||TWO_SIDED|95.0|-0.04|0.25||||||||0.25|-0.04|
70971301|NCT03016325|141448821|SUPERIORITY|Part II-Japan (low dose), clinically relevant hypotension - relative difference|Relative difference from placebo|0.33|||||TWO_SIDED|95.0|-0.17|0.78||||||||0.78|-0.17|
70971302|NCT03016325|141448821|SUPERIORITY|Part II-Japan (low dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.33|||||TWO_SIDED|95.0|-0.17|0.78||||||||0.78|-0.17|
70971303|NCT03016325|141448821|SUPERIORITY|Part II-Japan (high dose), clinically relevant hypotension - relative difference|Relative difference from placebo|0.5|||||TWO_SIDED|95.0|-0.04|0.88||||||||0.88|-0.04|
70971304|NCT03016325|141448821|SUPERIORITY|Part II-Japan (high dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.5|||||TWO_SIDED|95.0|-0.04|0.88||||||||0.88|-0.04|
70971305|NCT03016325|141448824|SUPERIORITY|Part I, symptoms of hypotension - relative risk|Relative risk from placebo|2.94|||||TWO_SIDED|95.0|0.31|75.47||||||||75.47|0.31|
70971306|NCT03016325|141448824|SUPERIORITY|Part I, symptoms of hypotension - relative difference|Relative difference from placebo|0.04|||||TWO_SIDED|95.0|-0.06|0.15||||||||0.15|-0.06|
70971307|NCT03016325|141448824|SUPERIORITY|Part II (low dose), symptoms of hypotension - relative risk|Relative risk from placebo|2.0|||||TWO_SIDED|95.0|0.18|54.35||||||||54.35|0.18|
70971308|NCT03016325|141448824|SUPERIORITY|Part II (low dose), symptoms of hypotension - relative difference|Relative difference from placebo|0.01|||||TWO_SIDED|95.0|-0.05|0.09||||||||0.09|-0.05|
71153973|NCT00488683|141800067|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup C||||
70971309|NCT03016325|141448824|SUPERIORITY|Part II (high dose), symptoms of hypotension - relative risk|Relative risk from placebo|5.92|||||TWO_SIDED|95.0|0.91|149.72||||||||149.72|0.91|
70971310|NCT03016325|141448824|SUPERIORITY|Part II (high dose), symptoms of hypotension - relative difference|Relative difference from placebo|0.07|||||TWO_SIDED|95.0|-0.01|0.16||||||||0.16|-0.01|
70971311|NCT03016325|141448825|SUPERIORITY|Part I, confirmed SBP \< 90 mmHg - relative risk|Relative risk from placebo|3.27|||||TWO_SIDED|95.0|1.01|14.66||||||||14.66|1.01|
70971312|NCT03016325|141448825|SUPERIORITY|Part I, confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.14|||||TWO_SIDED|95.0|0.0|0.29||||||||0.29|0.00|
70971313|NCT03016325|141448825|SUPERIORITY|Part II (low dose), confirmed SBP \< 90 mmHg - relative risk|Relative risk from placebo|1.15|||||TWO_SIDED|95.0|0.58|2.43||||||||2.43|0.58|
70971314|NCT03016325|141448825|SUPERIORITY|Part II (low dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.03|||||TWO_SIDED|95.0|-0.11|0.16||||||||0.16|-0.11|
70971315|NCT03016325|141448825|SUPERIORITY|Part II (high dose), confirmed SBP \< 90 mmHg - relative risk|Relative risk from placebo|1.59|||||TWO_SIDED|95.0|0.87|3.21||||||||3.21|0.87|
70971316|NCT03016325|141448825|SUPERIORITY|Part II (high dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.11|||||TWO_SIDED|95.0|-0.04|0.25||||||||0.25|-0.04|
70971317|NCT03016325|141448825|SUPERIORITY|Part II-Japan (low dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.33|||||TWO_SIDED|95.0|-0.17|0.78||||||||0.78|-0.17|
70971318|NCT03016325|141448825|SUPERIORITY|Part II-Japan (high dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.5|||||TWO_SIDED|95.0|-0.04|0.88||||||||0.88|-0.04|
70971319|NCT01902290|141448857|SUPERIORITY||Difference|-0.05||||0.5219|TWO_SIDED|95.0|-0.203|0.103|||Mixed-effect model|The model included fixed effects of treatment group, time, interaction of treatment group by time, stratification variables, and baseline ACQ score.|Difference = Brodalumab - Placebo|||0.103|-0.203|0.5219
70971320|NCT01902290|141448858|SUPERIORITY||Rate Ratio|1.41||||0.102|TWO_SIDED|95.0|0.93|2.12|||Generalized linear model|Generalized linear model under a negative binomial distribution assumption adjusting for stratification factors.|Rate ratio = Brodalumab : Placebo|||2.12|0.93|0.102
70971321|NCT01902290|141448859|SUPERIORITY||Difference|-0.038||||0.6632|TWO_SIDED|95.0|-0.21|0.134|||Mixed-effect model|The model included fixed effects of treatment group, time, interaction of treatment group by time, stratification factors, and baseline ACQ score.|Difference = Brodalumab - Placebo|||0.134|-0.210|0.6632
70971322|NCT01902290|141448860|SUPERIORITY||Rate Ratio|1.45||||0.096|TWO_SIDED|95.0|0.94|2.24|||Generalized linear model|Generalized linear model under a negative binomial distribution assumption adjusting for stratification factors.|Rate ratio = Brodalumab : Placebo|||2.24|0.94|0.096
70971323|NCT01902290|141448861|SUPERIORITY||Difference|-0.046||||0.329|TWO_SIDED|95.0|-0.137|0.046|||Mixed-effect model|The model included fixed effects of treatment group, time, interaction of treatment group by time, stratification variables, and baseline score.|Difference = Brodalumab - Placebo|||0.046|-0.137|0.3290
70971324|NCT01902290|141448862|SUPERIORITY||Difference|0.03||||0.4549||95.0|-0.049|0.109|||Mixed-effect model|Model includes treatment, time, stratification factors, treatment by time and baseline value of age, gender, pooled race group, height and FEV1.|Difference = Brodalumab - Placebo|||0.109|-0.049|0.4549
70971325|NCT01902290|141448863|SUPERIORITY||Difference|0.128||||0.6317||95.0|-0.396|0.653|||Mixed-effect model|The model included fixed effects of treatment group, time, interaction of treatment group by time, stratification variables, and baseline value.|Difference = Brodalumab - Placebo|||0.653|-0.396|0.6317
70971326|NCT01902290|141448864|SUPERIORITY||Hazard Ratio (HR)|1.277||||0.238|TWO_SIDED|95.0|0.843|1.936|||Log Rank|Log rank test stratified for baseline stratification factors.||||1.936|0.843|0.238
70971327|NCT01902290|141448865|SUPERIORITY||Odds Ratio (OR)|1.25||||0.351||95.0|0.78|2.01|||Regression, Logistic|Logistic regression adjusted for stratification factors.||||2.01|0.78|0.351
70971328|NCT01902290|141448866|SUPERIORITY||Difference|-0.001||||0.987||95.0|-0.174|0.171|||Mixed-effects model|The model included fixed effects of treatment group, time, interaction of treatment group by time, stratification variables, and baseline AQLQ score.|Difference = Brodalumab - Placebo|||0.171|-0.174|0.9870
70971329|NCT01902290|141448867|SUPERIORITY||Difference|0.635||||0.9053|TWO_SIDED|95.0|-9.82|11.089|||Mixed-effect model|Model includes treatment, time, stratification factors, treatment by time and baseline value of age, gender, pooled race group, height and AM PEFR.|Difference = Brodalumab - Placebo|Analysis of morning peak flow||11.089|-9.820|0.9053
70971330|NCT01902290|141448867|SUPERIORITY||Difference|5.92||||0.2661|TWO_SIDED|95.0|-4.515|16.354|||Mixed-effects model|Model includes treatment, time, stratification factors, treatment by time and baseline value of age, gender, pooled race group, height and PM PEFR.|Difference = Brodalumab - Placebo|Analysis of evening peak flow||16.354|-4.515|0.2661
70971331|NCT01902290|141448868|SUPERIORITY||Difference|-4.021||||0.0871|TWO_SIDED|95.0|-8.627|0.586|||Mixed-effect model|Model includes treatment, time, stratification factors, treatment by time and baseline value of age, gender, race group, height and PEFR variation.|Difference = Brodalumab - Placebo|||0.586|-8.627|0.0871
70971332|NCT03389854|141448876|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Control group vs Penile Traction Therapy Group at 3 months||||0.001
70971333|NCT03389854|141448876|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Control group vs Penile Traction Therapy Group at 6 months||||0.90
70971334|NCT03389854|141448877|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Control group vs Penile Traction Therapy Group at 3 months||||0.001
70971335|NCT03389854|141448877|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Control group vs. Penile Traction Therapy Group at 6 months||||0.40
70971336|NCT03389854|141448878|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Control group vs Penile Traction Therapy Group at 3 months||||0.01
70971337|NCT03389854|141448878|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Control group vs. Penile Traction Therapy Group at 6 months||||0.64
70971338|NCT03389854|141448879|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Control group vs Penile Traction Therapy Group at 3 months||||0.06
70971339|NCT03389854|141448879|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Control group vs Penile Traction Therapy Group at 6 months||||0.66
70971340|NCT03389854|141448880|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||||||0.09
70971341|NCT03389854|141448881|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.26
70971342|NCT03389854|141448882|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
70971343|NCT01618214|141448913|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.4%.|Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.08||||95.0|-0.19|0.14|||Regression, Linear|||FAS||0.14|-0.19|
70971344|NCT00391222|141448918|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED|95.0||||As defined in the protocol, the olanzapine arm was not included in the primary outcome comparison. Data on the olanzapine arm are presented in outcome measure 7.|Log Rank|||Comparison between risperidone LAI and placebo was performed using a log-rank test controlling for patient type at screening (acute or non-acute) and for geographic region. As recurrence rates at 9 months were assumed to be 45% for risperidone LAI and 68% for placebo, the study would have approximately 90% power to detect a clinically meaningful difference of 23% in recurrence rates of a mood episode if in Period III 100 patients were randomized to each of the 2 relevant treatment arms.||||0.057
70971345|NCT00391222|141448919|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|95.0|||||Log Rank|||The time-to-event data were evaluated by the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.||||0.005
70971346|NCT00391222|141448919|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||The time-to-event data were evaluated by the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.||||<0.0001
70971347|NCT00391222|141448920|SUPERIORITY_OR_OTHER|||||||0.655|TWO_SIDED|95.0|||||Log Rank|||The time-to-event data were evaluated by means of the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.||||0.655
70971348|NCT00391222|141448920|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|95.0|||||Log Rank|||The time-to-event data were evaluated by means of the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.||||0.011
70971349|NCT00391222|141448921|SUPERIORITY_OR_OTHER|||||||0.2882|TWO_SIDED|95.0|||||Log Rank|||The time-to-event data were evaluated by means of the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.||||0.2882
70971350|NCT00391222|141448921|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Log Rank|||The time-to-event data were evaluated by means of the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.||||<0.0001
70971351|NCT00391222|141448922|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||ANCOVA|||An ANCOVA model was applied to the change from baseline of Period III at each time point in Period III, with treatment, patient type at screening, and geographic region as factors and baseline YMRS total score as covariate. The comparison between active treatment and placebo was performed based on the LS means obtained from the ANCOVA model. The difference in LS means between treatment arms was estimated, as was the 95% confidence interval for the difference.||||<0.001
70971352|NCT00391222|141448922|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||ANCOVA|||An ANCOVA model was applied to the change from baseline of Period III at each time point in Period III, with treatment, patient type at screening, and geographic region as factors and baseline YMRS total score as covariate. The comparison between active treatment and placebo was performed based on the LS means obtained from the ANCOVA model. The difference in LS means between treatment arms was estimated, as was the 95% confidence interval for the difference.||||<0.001
71031809|NCT02728102|141572294|SUPERIORITY|||||||0.303||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of overall Survival between the lenalidomide/GM-CSF arm and lenalidomide alone arm.||||0.303
71031810|NCT02728102|141572296|SUPERIORITY|||||||0.189||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||The null hypothesis is that there is no difference of proportions of patients With Grade ≥ 3 Toxicities between vaccine vs. non- vaccine arms.||||0.189
70971353|NCT00391222|141448923|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|95.0|||||ANCOVA|||An ANCOVA model was applied to the change from baseline of Period III at each time point in Period III, with treatment, patient type at screening, and geographic region as factors and baseline MADRS total score as covariate. The comparison between active treatment and placebo was performed based on the LS means obtained from the ANCOVA model. The difference in LS means between treatment arms was estimated, as was the 95% confidence interval for the difference.||||0.480
71093300|NCT02629159|141693832|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-0.67|||<|0.001|TWO_SIDED|95.0|-0.97|-0.37||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.37|-0.97|<0.001
71093301|NCT02629159|141693832|SUPERIORITY||LS Mean Difference|0.14||||0.448|TWO_SIDED|95.0|-0.23|0.51||This comparison was not part of the pre-specified multiplicity testing sequence.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Adalimumab|||0.51|-0.23|0.448
71093302|NCT02629159|141693833|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.372|-0.253||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.253|-0.372|<0.001
71093303|NCT02629159|141693833|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-0.11||||0.004|TWO_SIDED|95.0|-0.184|-0.036||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA only.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Adalimumab|||-0.036|-0.184|0.004
71093304|NCT02629159|141693834|NON_INFERIORITY|A non-inferiority test of upadacitinib versus adalimumab was evaluated using the lower bound of the 95% confidence interval (CI) of the treatment difference against a non-inferiority margin of 10%. This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA only.|Response Rate Difference|16.1|||||TWO_SIDED|95.0|9.9|22.3|||||Response Rate Difference = Upadacitinib - Adalimumab|||22.3|9.9|
70918724|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.07||||0.4382|TWO_SIDED|95.0|0.9|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=50% reduction||1.28|0.90|0.4382
70971354|NCT00391222|141448923|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|95.0|||||ANCOVA|||An ANCOVA model was applied to the change from baseline of Period III at each time point in Period III, with treatment, patient type at screening, and geographic region as factors and baseline MADRS total score as covariate. The comparison between active treatment and placebo was performed based on the LS means obtained from the ANCOVA model. The difference in LS means between treatment arms was estimated, as was the 95% confidence interval for the difference.||||0.001
70971355|NCT00652366|141448932|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26||||0.2026|TWO_SIDED|95.0|0.88|1.8|||Log Rank|||||1.80|0.88|0.2026
71093305|NCT02629159|141693834|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|||||<|0.001||||||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA only.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use.||||||<0.001
71093306|NCT02629159|141693834|SUPERIORITY||Response Rate Difference|30.3|||<|0.001|TWO_SIDED|95.0|25.6|35.0||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo|||35.0|25.6|<0.001
71093307|NCT02629159|141693835|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|4.33|||<|0.001|TWO_SIDED|95.0|3.52|5.15||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||5.15|3.52|<0.001
70918725|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|0.95||||0.5638|TWO_SIDED|95.0|0.79|1.13|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=50% reduction||1.13|0.79|0.5638
70971356|NCT00652366|141448934|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.6298|TWO_SIDED|95.0|0.77|1.54|||Log Rank|||||1.54|0.77|0.6298
70971357|NCT00652366|141448935|SUPERIORITY_OR_OTHER||Difference in Response Rates|-6.1||||0.2543|TWO_SIDED|95.0|-17.2|5.0|||Chi-squared||Approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.|||5.0|-17.2|0.2543
70971358|NCT00652366|141448935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55|||||TWO_SIDED|95.0|0.19|1.56||||||||1.56|0.19|
70971359|NCT00652366|141448937|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|-15.52||||0.0603|TWO_SIDED|95.0|-32.4|1.3|||Chi-squared||Approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.|||1.3|-32.4|0.0603
70971360|NCT00652366|141448939|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.2678|TWO_SIDED|95.0|0.6|1.15|||Log Rank|||||1.15|0.60|0.2678
70971361|NCT00652366|141448939|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.8449|TWO_SIDED|95.0|0.74|1.43|||Log Rank|||||1.43|0.74|0.8449
70971362|NCT00652366|141448941|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.0217|TWO_SIDED|95.0|0.51|0.95|||Log Rank|||||0.95|0.51|0.0217
70971363|NCT00652366|141448941|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.1596|TWO_SIDED|95.0|0.57|1.1|||Log Rank|||||1.10|0.57|0.1596
70971364|NCT01890642|141448942|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Kruskal-Wallis|||||||0.01
70971365|NCT01890642|141448943|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Kruskal-Wallis|||||||0.80
70971366|NCT01890642|141448944|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||Kruskal-Wallis|||||||0.004
70971367|NCT01890642|141448945|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Kruskal-Wallis|||||||0.0001
70971368|NCT01890642|141448946|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Kruskal-Wallis|||||||0.37
70971369|NCT00137111|141448975|SUPERIORITY_OR_OTHER_LEGACY||Binomial proportion|79.27|||||TWO_SIDED|95.0|75.69|82.85|||Binomial proportion|||Of the 498 eligible patients, 492 were successfully evaluated with day 46 MRD measurement.||82.85|75.69|
70971370|NCT00137111|141448976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0062||||||p-value from t-test after stratified for lineage and ploidy|t-test, 2 sided|||t-test stratified for lineage and ploidy||||.0062
70971371|NCT00137111|141448977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15||||||p-value from t-test after adjusted for lineage and ploidy|t-test, 2 sided|||t-test adjusting for lineage and ploidy||||.15
71153974|NCT00488683|141800067|SUPERIORITY_OR_OTHER||R-square|0.0048||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup W-135||||
70971372|NCT00137111|141448978|SUPERIORITY_OR_OTHER_LEGACY|||||||9.5e-07|||||||Wilcoxon (Mann-Whitney)|||||||0.00000095
70971373|NCT00137111|141448979|SUPERIORITY_OR_OTHER_LEGACY|||||||7e-07|||||||Wilcoxon (Mann-Whitney)|||||||0.0000007
71093308|NCT02629159|141693835|SUPERIORITY||LS Mean Difference|1.62||||0.002|TWO_SIDED|95.0|0.62|2.62||This comparison was not part of the pre-specified multiplicity testing sequence.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||2.62|0.62|0.002
70971374|NCT04703075|141448983|SUPERIORITY||Risk Difference (RD)|5.5||||0.07|TWO_SIDED||||||Chi-squared, Corrected|||||||0.07
70971375|NCT02425826|141448985|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-39.84|||<|0.0001|TWO_SIDED|95.0|-54.39|-25.3|||ANCOVA|Based on 2-way ANCOVA with treatment and site as factors and baseline value as covariate.||||-25.30|-54.39|<0.0001
70971376|NCT02425826|141448986|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.5||||0.0008|TWO_SIDED|95.0|-3.9|-1.0|||ANCOVA|Based on 2-way ANCOVA with treatment and site as factors and baseline value as covariate.||||-1.0|-3.9|0.0008
70971377|NCT02425826|141448987|SUPERIORITY_OR_OTHER_LEGACY||Difference|21.0|||<|0.0001|TWO_SIDED|95.0|11.0|31.1||Two-sided p-value is based on the Cochran-Mantel-Haenszel test stratified by sites.|Cochran-Mantel-Haenszel||Two-sided 95% confidence intervals (CI) is based on normal approximation|||31.1|11.0|<0.0001
70971378|NCT02425826|141448988|SUPERIORITY_OR_OTHER_LEGACY||Difference|13.7||||0.0365|TWO_SIDED|95.0|1.7|25.7|||Cochran-Mantel-Haenszel|2-sided p-value is calculated based on Cochran-Mantel-Haenszel test stratified by sites.|Two-sided 95% CI is based on normal approximation|||25.7|1.7|0.0365
70971379|NCT02425826|141448989|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-11.6||||0.0016|TWO_SIDED|95.0|-18.8|-4.5|||ANCOVA|Based on 2-way ANCOVA with treatment and site as factors and baseline value as covariate.||The treatment comparison was only done for Week 16; End of Phase||-4.5|-18.8|0.0016
70971380|NCT02425826|141448990|SUPERIORITY_OR_OTHER_LEGACY||Difference|11.8||||0.0463|TWO_SIDED|95.0|-4.0|27.6|||Cochran-Mantel-Haenszel|p-value was based on 2-sided CMH tests stratified by sites.|Two-sided 95% CI is based on normal approximation.|||27.6|-4.0|0.0463
70971381|NCT02425826|141448991|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|17.8|||<|0.0001|TWO_SIDED|95.0|10.36|25.24|||ANOVA|Based on 2-way ANOVA with treatment and site as factors.||TSQM-Effectiveness||25.24|10.36|<0.0001
70971382|NCT02425826|141448991|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.0||||0.3433|TWO_SIDED|95.0|-5.4|15.4|||ANOVA|Based on 2-way ANOVA with treatment and site as factors.||TSQM - Side Effects||15.40|-5.40|0.3433
70971383|NCT02425826|141448991|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.4||||0.625|TWO_SIDED|95.0|-4.25|7.06|||ANOVA|Based on 2-way ANOVA with treatment and site as factors.||TSMQ-Convenience||7.06|-4.25|0.6250
70971384|NCT02425826|141448991|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.07|||<|0.0001|TWO_SIDED|95.0|7.16|20.97|||ANOVA|||TSQM-Global Satisfaction||20.97|7.16|<0.0001
70971385|NCT02425826|141448993|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-37.0|||<|0.0001|TWO_SIDED|95.0|-54.08|-19.91|||ANCOVA|Based on 2-way ANCOVA with treatment and site as factors and baseline value as covariate||||-19.91|-54.08|<0.0001
70971386|NCT02425826|141448994|SUPERIORITY_OR_OTHER_LEGACY||Difference|29.1|||<|0.0001|TWO_SIDED|95.0|16.3|41.8|||Cochran-Mantel-Haenszel|2-sided p-value is calculated based on Cochran-Mantel-Haenszel test stratified by sites.|Two-sided 95% CI is based on normal approximation|||41.8|16.3|<0.0001
70971387|NCT02425826|141448995|SUPERIORITY_OR_OTHER_LEGACY||Difference|13.5||||0.0136|TWO_SIDED|95.0|4.4|22.7|||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel test stratified by sites.|2-sided 95% CI is based on normal approximation.|||22.7|4.4|0.0136
70971388|NCT00853671|141449001|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Pearson Correlation|||||||<0.0001
70971389|NCT00853671|141449003|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Pearson Correlation|||Pearson Correlation||||<0.0001
70971390|NCT00507559|141449016|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||This is compared to a historical control group, in which 11.1% of subjects experienced one or more MAE within 30 days.||||<0.001
70971391|NCT00562588|141449047|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.067||||0.683||95.0|0.78|1.461|||Regression, Logistic|||The primary endpoint tele-mRS on day 90 was available in 527 of 543 treated patients (97.1%).||1.461|0.78|0.683
71093309|NCT02629159|141693836|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|Response Rate Difference|31.2|||<|0.001|TWO_SIDED|95.0|26.5|35.8||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo|||35.8|26.5|<0.001
71093310|NCT02629159|141693836|NON_INFERIORITY|A non-inferiority test of upadacitinib versus adalimumab was evaluated using the lower bound of the 95% confidence interval (CI) of the treatment difference against a non-inferiority margin of 10%. This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for EU/EMA only.|Response Rate Difference|16.3|||||TWO_SIDED|95.0|10.0|22.5|||||Response Rate Difference = Upadacitinib - Adalimumab|||22.5|10.0|
71093311|NCT02629159|141693836|SUPERIORITY||||||<|0.001||||||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use||||||<0.001
71093312|NCT02629159|141693837|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|Response Rate Difference|24.1|||<|0.001|TWO_SIDED|95.0|19.4|28.8||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use.|Response Rate Difference = Upadacitinib - Placebo|||28.8|19.4|<0.001
71093313|NCT02629159|141693837|SUPERIORITY||Response Rate Difference|10.4||||0.001|TWO_SIDED|95.0|4.2|16.7||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Adalimumab|||16.7|4.2|0.001
71093314|NCT02629159|141693838|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-44.04|||<|0.001|TWO_SIDED|95.0|-55.39|-32.69||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-32.69|-55.39|<0.001
70918726|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.05||||0.6436|TWO_SIDED|95.0|0.86|1.27|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=70% reduction||1.27|0.86|0.6436
70918727|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.04||||0.706|TWO_SIDED|95.0|0.85|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=70% reduction||1.26|0.85|0.7060
70918728|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|0.96||||0.7729|TWO_SIDED|95.0|0.72|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=90% reduction||1.28|0.72|0.7729
70918729|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.07||||0.6405|TWO_SIDED|95.0|0.81|1.42|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=90% reduction||1.42|0.81|0.6405
70918730|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9046|TWO_SIDED|95.0|0.85|1.21|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=30% reduction||1.21|0.85|0.9046
71093315|NCT02629159|141693838|SUPERIORITY||LS Mean Difference|-9.92||||0.164|TWO_SIDED|95.0|-23.89|4.05||This comparison was not part of the pre-specified multiplicity testing sequence.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||4.05|-23.89|0.164
70918731|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|0.93||||0.4491|TWO_SIDED|95.0|0.78|1.11|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=30% reduction||1.11|0.78|0.4491
70918732|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7429|TWO_SIDED|95.0|0.86|1.23|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=50% reduction||1.23|0.86|0.7429
70918733|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|0.92||||0.3467|TWO_SIDED|95.0|0.77|1.1|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=50% reduction||1.10|0.77|0.3467
71153975|NCT00488683|141800067|SUPERIORITY_OR_OTHER||R-square|0.0018||||||95.0|||||Regression, Linear||Values from Groups 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup W-135||||
70971392|NCT00562588|141449048|SUPERIORITY_OR_OTHER|||||||0.607||95.0|||||ANCOVA|ANCOVA with factors for treatment, age, weight, baseline SBP, diabetes, previous stroke and baseline NIHSS||Early treatment initiation (immediately after the index event) with Aggrenox was compared to late initiation of Aggrenox after 7 days of treatment with ASA mono||||0.607
70971393|NCT00562588|141449049|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.725||||0.202||95.0|0.442|1.189|||Cox proportional hazards model|||Early treatment initiation (immediately after the index event) with Aggrenox was compared to late initiation of Aggrenox after 7 days of treatment with ASA mono||1.189|0.442|0.202
70971394|NCT05032157|141449064|SUPERIORITY||Mean Difference (Final Values)|-7.68|STANDARD_ERROR_OF_MEAN|1.136|<|0.001|TWO_SIDED|95.0|-9.91|-5.46|||Mixed Models Analysis||MMRM adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, week, baseline score and both interaction of treatment by week and interaction of baseline score by week.|UAS7 at Week 12 (Scenario 1 with UAS7 as primary efficacy endpoint)||-5.46|-9.91|< 0.001
70971395|NCT05032157|141449065|SUPERIORITY||Mean Difference (Final Values)|-3.23|STANDARD_ERROR_OF_MEAN|0.545|<|0.001|TWO_SIDED|95.0|-4.29|-2.16|||Mixed Models Analysis||MMRM adjusting for treatment arm, geographical region, prior exposure to anti- IgE, biologics, week, baseline score, and both interaction of treatment by week and interaction of baseline score by week.|ISS7 at Week 12 (Scenario 2 with ISS7 and HSS7 as co-primary efficacy endpoints)||-2.16|-4.29|<0.001
70971396|NCT05032157|141449066|SUPERIORITY||Mean Difference (Final Values)|-4.47|STANDARD_ERROR_OF_MEAN|0.634|<|0.001|TWO_SIDED|95.0|-5.71|-3.23|||Mixed Models Analysis||MMRM adjusting for treatment arm, geographical region, prior exposure to anti- IgE biologics, week, baseline score and both interaction of treatment by week and interaction of baseline score by week.|HSS7 at Week 12 (Scenario 2 with ISS7 and HSS7 as co-primary efficacy endpoints)||-3.23|-5.71|< 0.001
70971397|NCT05032157|141449067|SUPERIORITY||Odds Ratio (OR)|3.84|||<|0.001|TWO_SIDED|95.0|2.39|6.18|||Regression, Logistic||Logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, and baseline UAS7 score.|Disease activity control (UAS7 =\< 6) at Week 12||6.18|2.39|< 0.001
70971398|NCT05032157|141449068|SUPERIORITY||Odds Ratio (OR)|5.78|||<|0.001|TWO_SIDED|95.0|2.83|11.78|||Regression, Logistic||Logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, and baseline UAS7 score.|Complete absence of hives and itch (UAS7 = 0) at Week 12||11.78|2.83|< 0.001
70971399|NCT05032157|141449069|SUPERIORITY||Odds Ratio (OR)|7.92|||<|0.001|TWO_SIDED|95.0|3.72|16.85|||Regression, Logistic||Logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, and baseline UAS7 score.|Early onset of disease activity control (UAS7 =\< 6) at Week 2||16.85|3.72|< 0.001
70971400|NCT05032157|141449070|SUPERIORITY||Odds Ratio (OR)|2.75|||<|0.001|TWO_SIDED|95.0|1.65|4.58|||Regression, Logistic||Logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics and baseline DLQI score.|Dermatology Life Quality Index (DLQI) = 0-1 at Week 12||4.58|1.65|< 0.001
70971401|NCT05032157|141449071|SUPERIORITY||Rate ratio|3.26|||<|0.001|TWO_SIDED|95.0|2.26|4.71|||Regression, Linear||Negative binomial regression with log link includes treatment arm as fixed effect, geographical region, prior exposure to anti-IgE biologics as covariates. A rate ratio \>1 favors LOU064 25 mg b.i.d.|Disease activity control (UAS7 =\< 6) up to Week 12||4.71|2.26|< 0.001
70918734|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7624|TWO_SIDED|95.0|0.85|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=70% reduction||1.26|0.85|0.7624
70971402|NCT05032157|141449072|SUPERIORITY||Rate ratio|1.32|||<|0.001|TWO_SIDED|95.0|1.17|1.49|||Regression, Linear||Negative binomial regression with log link included treatment arm as fixed effect, geographical region, prior exposure to anti-IgE biologics, baseline AAS7 = 0 response as covariates. A rate ratio \> 1 favors LOU064 25 mg b.i.d.|Angioedema occurrence-free weeks (AAS7 = 0 response) up to Week 12||1.49|1.17|< 0.001
71093316|NCT02629159|141693839|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|4.15|||<|0.001|TWO_SIDED|95.0|3.13|5.16||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate|Treatment Difference = Upadacitinib - Placebo|||5.16|3.13|<0.001
70971403|NCT00150592|141449074|SUPERIORITY_OR_OTHER_LEGACY|||||||0.844||95.0|||||ANCOVA|||||||0.844
70971404|NCT00150592|141449075|SUPERIORITY_OR_OTHER_LEGACY|||||||0.274||95.0|||||ANCOVA|Mean reaction time (adjusted) for each randomized treatment group at endpoint.||||||0.274
70971405|NCT00150592|141449077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.307||95.0|||||ANCOVA|||Between errors||||0.307
70971406|NCT00150592|141449077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.552||95.0|||||ANCOVA|||Within errors||||0.552
70971407|NCT00150592|141449077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.917||95.0|||||ANCOVA|||Double errors||||0.917
71153976|NCT00488683|141800067|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup Y||||
70918735|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|0.97||||0.7686|TWO_SIDED|95.0|0.8|1.18|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=70% reduction||1.18|0.80|0.7686
70971408|NCT00150592|141449077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.068||95.0|||||ANCOVA|||Strategy||||0.068
70971409|NCT00150592|141449078|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||ANCOVA|||||||0.001
70971410|NCT00150592|141449079|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0|||||Cochran-Mantel-Haenszel|||||||0.007
70971411|NCT00150592|141449080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||ANCOVA|||||||0.02
70971412|NCT00150592|141449081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.231||95.0|||||ANCOVA|||||||0.231
71093317|NCT02629159|141693839|SUPERIORITY||LS Mean Difference|1.51||||0.017|TWO_SIDED|95.0|0.27|2.76||This comparison was not part of the pre-specified multiplicity testing sequence.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||2.76|0.27|0.017
70918736|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9384|TWO_SIDED|95.0|0.74|1.33|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=90% reduction||1.33|0.74|0.9384
70918737|NCT02528188|141328692|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8495|TWO_SIDED|95.0|0.77|1.38|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=90% reduction||1.38|0.77|0.8495
70918738|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.19||||0.0651|TWO_SIDED|95.0|0.99|1.44|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=30% reduction||1.44|0.99|0.0651
70918739|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9032|TWO_SIDED|95.0|0.84|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=30% reduction||1.22|0.84|0.9032
70918740|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.36||||0.01|TWO_SIDED|95.0|1.08|1.72|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=50% reduction||1.72|1.08|0.0100
70918741|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.12||||0.3728|TWO_SIDED|95.0|0.88|1.42|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=50% reduction||1.42|0.88|0.3728
70918742|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.44||||0.0434|TWO_SIDED|95.0|1.01|2.04|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=70% reduction||2.04|1.01|0.0434
70918743|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.44||||0.0425|TWO_SIDED|95.0|1.01|2.04|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=70% reduction||2.04|1.01|0.0425
70918744|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.22||||0.5442|TWO_SIDED|95.0|0.64|2.34|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=90% reduction||2.34|0.64|0.5442
70918745|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0349|TWO_SIDED|95.0|1.05|3.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=90% reduction||3.45|1.05|0.0349
70918746|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.26||||0.0108|TWO_SIDED|95.0|1.05|1.51|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=30% reduction||1.51|1.05|0.0108
70918747|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.27||||0.008|TWO_SIDED|95.0|1.07|1.52|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=30% reduction||1.52|1.07|0.0080
70918748|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.5|||<|0.0001|TWO_SIDED|95.0|1.22|1.83|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=50% reduction||1.83|1.22|<0.0001
70918749|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.51|||<|0.0001|TWO_SIDED|95.0|1.24|1.85|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=50% reduction||1.85|1.24|<0.0001
70918750|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.45||||0.006|TWO_SIDED|95.0|1.11|1.88|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=70% reduction||1.88|1.11|0.0060
70971413|NCT02227693|141449086|OTHER||Difference of responder rate vs. placebo|19.5||||0.146|TWO_SIDED|95.0|-18.1|57.0|||Shirley-Williams test|P-value is based on Shirley-Williams test at a one-sided significance level of α = 0.025.|Difference of responder rate vs. placebo = responder rate for avatrombopag - responder rate for placebo; 95% CI is calculated based on normal approximation.|||57.0|-18.1|0.146
71153977|NCT00488683|141800067|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup Y||||
70918751|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.49||||0.0031|TWO_SIDED|95.0|1.14|1.93|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=70% reduction||1.93|1.14|0.0031
70918752|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0235|TWO_SIDED|95.0|1.08|2.88|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=90% reduction||2.88|1.08|0.0235
70918753|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|2.12||||0.0021|TWO_SIDED|95.0|1.31|3.42|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=90% reduction||3.42|1.31|0.0021
70918754|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7613|TWO_SIDED|95.0|0.86|1.23|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=30% reduction||1.23|0.86|0.7613
70918755|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.19||||0.0548|TWO_SIDED|95.0|1.0|1.43|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=30% reduction||1.43|1.00|0.0548
70918756|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.25||||0.0196|TWO_SIDED|95.0|1.04|1.51|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=50% reduction||1.51|1.04|0.0196
70918757|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.45|||<|0.0001|TWO_SIDED|95.0|1.2|1.75|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=50% reduction||1.75|1.20|<0.0001
70918758|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.39||||0.0077||95.0|1.09|1.77|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=70% reduction||1.77|1.09|0.0077
70918759|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.65|||<|0.0001|TWO_SIDED|95.0|1.3|2.09|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=70% reduction||2.09|1.30|<0.0001
70918760|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.31||||0.1942|TWO_SIDED|95.0|0.87|1.96|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=90% reduction||1.96|0.87|0.1942
70918761|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0122|TWO_SIDED|95.0|1.11|2.43|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=90% reduction||2.43|1.11|0.0122
70918762|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.18||||0.0977|TWO_SIDED|95.0|0.97|1.43|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=30% reduction||1.43|0.97|0.0977
70918763|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.19||||0.0806|TWO_SIDED|95.0|0.98|1.44|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=30% reduction||1.44|0.98|0.0806
71031811|NCT02728102|141572298|SUPERIORITY|||||||0.82||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Participants with Grade 2 and 3 infections between vaccine vs. non- vaccine arms.||||0.82
71031812|NCT02728102|141572299|SUPERIORITY|||||||0.21||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Participants with Grade 2 and 3 infections between the vaccine arm and lenalidomide/GM-CSF arm.||||0.21
71031813|NCT02728102|141572299|SUPERIORITY|||||||0.4||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Participants with Grade 2 and 3 infections between the vaccine arm and lenalidomide alone arm.||||0.40
71031814|NCT02728102|141572299|SUPERIORITY|||||||0.08||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Participants with Grade 2 and 3 infections between the lenalidomide/GM-CSF arm and lenalidomide alone arm.||||0.08
71031815|NCT02728102|141572300|SUPERIORITY|||||||0.8||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||The null hypothesis is that there is no difference of proportions of patients without Minimal Residual Disease between vaccine vs. non- vaccine arms||||0.80
71031816|NCT02924883|141572305|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.3332||95.0|0.55|1.23|||Log Rank|The 2-sided log-rank test, was stratified by world region (Western Europe vs U.S. vs Rest of World) and PD-L1 status (IC 0 vs IC 1/2/3).||||1.23|0.55|0.3332
71153978|NCT00488683|141800067|SUPERIORITY_OR_OTHER||R-square|0.27||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup A||||
70971414|NCT02227693|141449086|OTHER||Difference of responder rate vs. placebo|54.5||||0.004|TWO_SIDED|95.0|21.4|87.7|||Shirley-Williams test|P-value is based on Shirley-Williams test at a one-sided significance level of α = 0.025.|Difference of responder rate vs. placebo = responder rate for avatrombopag - responder rate for placebo; 95% CI is calculated based on normal approximation.|||87.7|21.4|0.004
70971415|NCT02227693|141449086|OTHER||Difference of responder rate vs. placebo|30.9||||0.024|TWO_SIDED|95.0|-3.9|65.7|||Shirley-Williams test|P-value is based on Shirley-Williams test at a one-sided significance level of α = 0.025.|Difference of responder rate vs. placebo = responder rate for avatrombopag - responder rate for placebo; 95% CI is calculated based on normal approximation.|||65.7|-3.9|0.024
70971416|NCT02227693|141449087|OTHER||Difference of proportion vs. placebo|14.3||||0.388|TWO_SIDED|95.0|-11.6|40.2||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 3 (Day 4 or Day 5)||40.2|-11.6|0.388
70971417|NCT02227693|141449087|OTHER||Difference of proportion vs. placebo|27.3||||0.214|TWO_SIDED|95.0|1.0|53.6||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 3 (Day 4 or Day 5)||53.6|1.0|0.214
70971418|NCT02227693|141449087|OTHER||Difference of proportion vs. placebo|62.3||||0.012|TWO_SIDED|95.0|24.8|99.9||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 4 (Day 10)||99.9|24.8|0.012
70971419|NCT02227693|141449087|OTHER||Difference of proportion vs. placebo|72.7||||0.001|TWO_SIDED|95.0|44.3|100.0||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 4 (Day 10)||100.0|44.3|0.001
70971420|NCT02227693|141449087|OTHER||Difference of proportion vs. placebo|40.9||||0.063|TWO_SIDED|95.0|5.6|76.2||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 4 (Day 10)||76.2|5.6|0.063
70971421|NCT02227693|141449087|OTHER||Difference of proportion vs. placebo|-27.3||||0.245|TWO_SIDED|95.0|-53.6|-1.0||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 5 (Day 17)||-1.0|-53.6|0.245
70971422|NCT02227693|141449087|OTHER||Difference of proportion vs. placebo|27.3||||0.386|TWO_SIDED|95.0|-12.2|66.8||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 5 (Day 17)||66.8|-12.2|0.386
70971423|NCT02227693|141449087|OTHER||Difference of proportion vs. placebo|-7.3||||1|TWO_SIDED|95.0|-43.4|28.9||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 5 (Day 17)||28.9|-43.4|1.000
70971424|NCT02227693|141449087|OTHER||Difference of proportion vs. placebo|-18.2||||0.496|TWO_SIDED|95.0|-41.0|4.6||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 6 (Day 35)||4.6|-41.0|0.496
70971425|NCT02227693|141449087|OTHER||Difference of proportion vs. placebo|-9.1||||1|TWO_SIDED|95.0|-37.5|19.3||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 6 (Day 35)||19.3|-37.5|1.000
70971426|NCT02227693|141449087|OTHER||Difference of proportion vs. placebo|-18.2||||0.476|TWO_SIDED|95.0|-41.0|4.6||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 6 (Day 35)||4.6|-41.0|0.476
70971427|NCT02227693|141449088|OTHER||Difference of proportion vs. placebo|63.6||||0.003|TWO_SIDED|95.0|35.2|92.1||P-value is based on Fisher's exact test at a two-sided significance level of α= 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 4 (Day 10)||92.1|35.2|0.003
70971428|NCT02227693|141449088|OTHER||Difference of proportion vs. placebo|30.0||||0.09|TWO_SIDED|95.0|1.6|58.4||P-value is based on Fisher's exact test at a two-sided significance level of α= 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 4 (Day 10)||58.4|1.6|0.090
71031817|NCT02924883|141572307|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.2934||95.0|0.42|1.3|||Log Rank|The 2-sided log-rank test was stratified by world region (Western Europe vs U.S. vs Rest of World) and PD-L1 status (IC 0 vs IC 1/2/3).||||1.30|0.42|0.2934
71031818|NCT02924883|141572309|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.6099||95.0|0.52|3.03|||Log Rank|Stratified Cox proportional hazards model was stratified by world region (Western Europe, U.S., Rest of World) and PD-L1 status (IC 0, IC 1/2/3).||||3.03|0.52|0.6099
71031819|NCT02605395|141572323|EQUIVALENCE|The confidence intervals of logarithmically transformed ratio (Idiazole/Pariet) for Cmax to be within 80-125% to prove equivalency.|Ratio of means|95.71|||||TWO_SIDED|90.0|90.12|101.65||||||||101.65|90.12|
70971429|NCT02227693|141449088|OTHER||Difference of proportion vs. placebo|10.0||||0.476|TWO_SIDED|95.0|-8.6|28.6||P-value is based on Fisher's exact test at a two-sided significance level of α= 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 5 (Day 17)||28.6|-8.6|0.476
70971430|NCT02227693|141449091|OTHER|||||||0.296||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 3 (Day 4 or Day 5)||||0.296
70971431|NCT02227693|141449091|OTHER|||||||0.07||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 3 (Day 4 or Day 5)||||0.070
70971432|NCT02227693|141449091|OTHER|||||||0.138||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 3 (Day 4 or Day 5)||||0.138
70971433|NCT02227693|141449091|OTHER|||||||0.012||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 4 (Day 10)||||0.012
70971434|NCT02227693|141449091|OTHER|||||||0.001||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 4 (Day 10)||||0.001
70971435|NCT02227693|141449091|OTHER|||||||0.001||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 4 (Day 10)||||0.001
70971436|NCT02227693|141449091|OTHER|||||||0.624||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 5 (Day 17)||||0.624
70971437|NCT02227693|141449091|OTHER|||||||0.009||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 5 (Day 17)||||0.009
70971438|NCT02227693|141449091|OTHER|||||||0.01||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 5 (Day 17)||||0.010
70971439|NCT02227693|141449091|OTHER|||||||0.154||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 6 (Day 35)||||0.154
70971440|NCT02227693|141449091|OTHER|||||||0.216||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 6 (Day 35)||||0.216
70971441|NCT02227693|141449091|OTHER|||||||0.901||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 6 (Day 35)||||0.901
70971442|NCT00874120|141449098|SUPERIORITY_OR_OTHER||residual error term from the ANOVA|-0.5||||0.548|TWO_SIDED|95.0|-2.0|1.1||P-value is based on an ANOVA model including sequence, subject within sequence, period and treatment as factors.|ANOVA|||||1.1|-2.0|0.5480
70971443|NCT02164981|141449104|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.57|TWO_SIDED|||||No adjustment for multiple comparisons, as there was only one primary outcome variable.|ANCOVA|||Given the sequential parallel comparison design (SPCD), we used a two-stage test (weighted z-test, Tamura approach: CHANGE\_score = BASELINE\_value + GROUP (i.e., SNP vs. placebo)) to combine the data on treatment effects from phases 1 and 2 (weighted equally). Assessments were on Day -1 (phase 1 baseline), Day 13 (phase 1 outcome, phase 2 baseline) and Day 28 (phase 2 outcome). Only participants who at least started the infusion were included in analysis (i.e., modified intent to treat).||||0.57
70971444|NCT02164981|141449104|SUPERIORITY||Mean Difference (Final Values)|-1.09||||0.54|TWO_SIDED|||||No adjustment for multiple comparisons, as there was only one primary outcome variable.|ANCOVA|||The same analysis as in Analysis 1 was conducted, except that CLOZAPINE (i.e., patient used clozapine vs. other antipsychotic) was added as a covariate.||||0.54
70971445|NCT02164981|141449105|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.35|TWO_SIDED|||||Exploratory efficacy outcome, hence no adjustment for multiple comparison.|ANCOVA|||||||0.35
70971446|NCT02164981|141449105|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.37|TWO_SIDED|||||Exploratory efficacy outcome, hence no adjustment for multiple comparisons|ANCOVA|||||||0.37
70971447|NCT02164981|141449106|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.85|TWO_SIDED||||||ANCOVA|||||||0.85
70971448|NCT02164981|141449106|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.88|TWO_SIDED||||||ANCOVA|||||||0.88
70971449|NCT02164981|141449107|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.86|TWO_SIDED||||||ANCOVA|||||||0.86
70971450|NCT02164981|141449107|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.83|TWO_SIDED||||||ANCOVA|||||||0.83
70971451|NCT02164981|141449113|SUPERIORITY||Mean Difference (Final Values)|1.12||||0.33|TWO_SIDED||||||ANCOVA|||||||0.33
70971452|NCT02164981|141449113|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.34|TWO_SIDED||||||ANCOVA|||||||0.34
70971453|NCT02164981|141449116|SUPERIORITY||Mean Difference (Final Values)|1.11||||0.34|TWO_SIDED||||||ANCOVA|||||||0.34
70971454|NCT02164981|141449116|SUPERIORITY||Mean Difference (Final Values)|2.05||||0.36|TWO_SIDED||||||ANCOVA|||||||0.36
70971455|NCT02404103|141449129|EQUIVALENCE|The primary goal of the current study is to determine the effects of Aerospan on lung function in children with small airway obstruction with two doses.||||||0.148|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used||||||.148
70971456|NCT02404103|141449129|EQUIVALENCE|A goal was to evaluate whether flunisolide HFA 320 mcg when compared to flunisolide 160 mcg lead to significantly better improvement in the same outcome measures over time.||||||0.74|||||||Mixed Models Analysis|||||||.740
70971457|NCT02404103|141449129|EQUIVALENCE|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used||||||0.921|||||||Mixed Models Analysis|||||||.921
70971458|NCT02404103|141449130|EQUIVALENCE|The primary goal of the current study is to determine the effects of Aerospan on lung function in children with small airway obstruction.||||||0.872|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used||||||.872
70971459|NCT02404103|141449130|EQUIVALENCE|secondary goal was to evaluate whether flunisolide HFA 320 mcg when compared to flunisolide 160 mcg lead to significantly better improvement in the same outcome measures over time.||||||0.82|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used||||||0.820
70971460|NCT02404103|141449130|EQUIVALENCE|A goal was to evaluate whether flunisolide HFA 320 mcg when compared to flunisolide 160 mcg lead to significantly better improvement in the same outcome measures over time.||||||0.582|||||||Mixed Models Analysis|||||||0.582
70971461|NCT02404103|141449131|EQUIVALENCE|The primary aim is to compare the average change in spirometric values (FEV1 and FEF25-75%) and AX from baseline to Week 6 from participants randomized flunisolide HFA 1 inhalation BID and to flunisolide HFA 2 inhalations BID.||||||0.782|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used.||||||.782
70971462|NCT02404103|141449131|EQUIVALENCE|The primary aim is to compare the average change in spirometric values (FEV1 and FEF25-75%) and AX from baseline to Week 6 from participants randomized flunisolide HFA 1 inhalation BID and to flunisolide HFA 2 inhalations BID.||||||0.906|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used.||||||.906
71093318|NCT02629159|141693840|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-6.45|||<|0.001|TWO_SIDED|95.0|-9.63|-3.27||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA only.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||-3.27|-9.63|<0.001
71093319|NCT02629159|141693840|SUPERIORITY||LS Mean Difference|-16.3|||<|0.001|TWO_SIDED|95.0|-18.89|-13.71||This comparison was not part of the pre-specified multiplicity testing sequence.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-13.71|-18.89|<0.001
71093320|NCT02629159|141693841|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|Response Rate Difference|7.5|||<|0.001|TWO_SIDED|95.0|3.0|12.1||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for EU/EMA only.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo|||12.1|3.0|<0.001
70918764|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.12||||0.2097|TWO_SIDED|95.0|0.94|1.34|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=50% reduction||1.34|0.94|0.2097
70918765|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.25||||0.0135|TWO_SIDED|95.0|1.05|1.49|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=50% reduction||1.49|1.05|0.0135
70918766|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.1||||0.3571|TWO_SIDED|95.0|0.9|1.33|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=70% reduction||1.33|0.90|0.3571
70971463|NCT02404103|141449131|EQUIVALENCE|The primary aim is to compare the average change in spirometric values (FEV1 and FEF25-75%) and AX from baseline to Week 6 from participants randomized flunisolide HFA 1 inhalation BID and to flunisolide HFA 2 inhalations BID.||||||0.102|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used.||||||.102
71093321|NCT02629159|141693841|SUPERIORITY||Response Rate Difference|-3.4||||0.187|TWO_SIDED|95.0|-8.2|1.5||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use.|Response Rate Difference = Upadacitinib - Adalimumab|||1.5|-8.2|0.187
71093322|NCT02629159|141693842|SUPERIORITY||Response Rate Difference|20.0|||<|0.001|TWO_SIDED|95.0|16.3|23.7||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo|||23.7|16.3|<0.001
71153979|NCT00488683|141800067|SUPERIORITY_OR_OTHER||R-square|0.19||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup A||||
70971464|NCT02404103|141449132|EQUIVALENCE|To assess the impact of flunisolide on small airway parameters using spirometry and impulse oscillometry and determine whether there is a dose-related difference (320 mcg vs 160 mcg) with flunisolide HFA in pediatric patients who have evidence of small airway obstruction.||||||0.62|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used.||||||.620
70971465|NCT02404103|141449132|EQUIVALENCE|To assess the impact of flunisolide on small airway parameters using spirometry and impulse oscillometry and determine whether there is a dose-related difference (320 mcg vs 160 mcg) with flunisolide HFA in pediatric patients who have evidence of small airway obstruction.||||||0.543|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used||||||.543
71093323|NCT02629159|141693842|SUPERIORITY||Response Rate Difference|11.4|||<|0.001|TWO_SIDED|95.0|6.5|16.4||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Adalimumab|||16.4|6.5|<0.001
70918767|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.34||||0.0025|TWO_SIDED|95.0|1.11|1.63|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=70% reduction||1.63|1.11|0.0025
70918768|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.11||||0.4658|TWO_SIDED|95.0|0.83|1.49|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=90% reduction||1.49|0.83|0.4658
70918769|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.44||||0.0108|TWO_SIDED|95.0|1.09|1.9|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=90% reduction||1.90|1.09|0.0108
70918770|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8393|TWO_SIDED|95.0|0.85|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=30% reduction||1.22|0.85|0.8393
70971466|NCT02404103|141449132|EQUIVALENCE|To assess the impact of flunisolide on small airway parameters using spirometry and impulse oscillometry and determine whether there is a dose-related difference (320 mcg vs 160 mcg) with flunisolide HFA in pediatric patients who have evidence of small airway obstruction.||||||0.6|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used||||||.6
70971467|NCT00328627|141449133|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54|||<|0.001|TWO_SIDED|95.0|-0.67|-0.41||For the primary analysis, the overall average HbA1c response of the Alogliptin/pioglitazone combination groups was compared with that of the pioglitazone alone groups at the 2-sided 0.05 significance level with no adjustment for multiple comparisons.|ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||The null hypothesis was that the doses of alogliptin do not have any additive effect on glycemic control (HbA1c) in addition to the effect produced by pioglitazone alone. The alternative hypothesis was that at least the higher dose of alogliptin would have an additive effect on glycemic control (HbA1c) in addition to the effect produced by pioglitazone alone.||-0.41|-0.67|<0.001
70971468|NCT00328627|141449133|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.53|||<|0.001|TWO_SIDED|95.0|-0.66|-0.41|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.41|-0.66|<0.001
70971469|NCT00328627|141449165|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|||<|0.001|TWO_SIDED|95.0|-0.93|-0.48||As a supportive analysis, each of the individual combination treatment groups was compared with the component treatment groups receiving aloliptin alone and pioglitazone alone at the 2-sided 0.05 significance level with no multiplicity adjustment.|ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.48|-0.93|<0.001
70971470|NCT00328627|141449165|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.59|||<|0.001|TWO_SIDED|95.0|-0.81|-0.38|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.38|-0.81|<0.001
71093324|NCT03033355|141693868|OTHER|||||||0.0012||||||Threshold for statistical significance used P-value \<0.05|Student t-Test|||Right Cingulate Body||||0.0012
70918771|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.1||||0.2977|TWO_SIDED|95.0|0.92|1.32|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=30% reduction||1.32|0.92|0.2977
70918772|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.12||||0.1944|TWO_SIDED|95.0|0.94|1.34|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=50% reduction||1.34|0.94|0.1944
70971471|NCT00328627|141449165|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.37||||0.001|TWO_SIDED|95.0|-0.59|-0.15|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.15|-0.59|0.001
70971472|NCT00328627|141449165|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.74|-0.3|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.30|-0.74|<0.001
70971473|NCT00328627|141449165|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.76|||<|0.001|TWO_SIDED|95.0|-0.98|-0.53|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.53|-0.98|<0.001
70971474|NCT00328627|141449165|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.7|-0.25|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.25|-0.70|<0.001
70971475|NCT00328627|141449165|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.49|||<|0.001|TWO_SIDED|95.0|-0.71|-0.27|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.27|-0.71|<0.001
70971476|NCT00328627|141449165|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.7|-0.25|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.25|-0.70|<0.001
70971477|NCT00328627|141449165|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.91|||<|0.001|TWO_SIDED|95.0|-1.13|-0.68|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.68|-1.13|<0.001
71093325|NCT03033355|141693868|OTHER|||||||0.02||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Left Posterior Cingulate||||0.02
71093326|NCT03033355|141693868|OTHER|||||||0.0015||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Left Anterior Cingulate||||0.0015
71093327|NCT03033355|141693868|OTHER|||||||0.0015||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Right Prefrontal Cortex||||0.0015
71093328|NCT03033355|141693868|OTHER|||||||0.0138||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Left Insula||||0.0138
71093329|NCT03033355|141693868|OTHER|||||||0.049||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Pons Micturition Center||||0.049
71093330|NCT03033355|141693868|OTHER|||||||0.001||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Left Cerebellum||||0.001
71093331|NCT03033355|141693868|OTHER|||||||0.026||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Left Lentiform Nucleus||||0.026
71093332|NCT03033355|141693868|OTHER|||||||0.026||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Right Lentiform Nucleus||||0.026
71153980|NCT00488683|141800067|SUPERIORITY_OR_OTHER||R-square|0.08||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup C||||
70918773|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.05||||0.5714|TWO_SIDED|95.0|0.88|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=50% reduction||1.26|0.88|0.5714
70918774|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.12||||0.2472|TWO_SIDED|95.0|0.92|1.36|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=70% reduction||1.36|0.92|0.2472
70918775|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.25||||0.0235|TWO_SIDED|95.0|1.03|1.51|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=70% reduction||1.51|1.03|0.0235
70918776|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.13||||0.4074|TWO_SIDED|95.0|0.85|1.51|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=90% reduction||1.51|0.85|0.4074
70918777|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.37||||0.0296|TWO_SIDED|95.0|1.03|1.81|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=90% reduction||1.81|1.03|0.0296
70918778|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7607|TWO_SIDED|95.0|0.86|1.23|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=30% reduction||1.23|0.86|0.7607
70971478|NCT00328627|141449165|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.55|||<|0.001|TWO_SIDED|95.0|-0.77|-0.33|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.33|-0.77|<0.001
70971479|NCT00328627|141449165|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|||<|0.001|TWO_SIDED|95.0|-0.92|-0.48|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.48|-0.92|<0.001
70971480|NCT00328627|141449165|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.61|||<|0.001|TWO_SIDED|95.0|-0.83|-0.39|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.39|-0.83|<0.001
70971481|NCT01137773|141449291|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||||||0.49
71093333|NCT03033355|141693868|OTHER|||||||0.015||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Left Amygdala/parahippocampal Gyrus||||0.015
71093334|NCT04717557|141693875|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
70971482|NCT01137773|141449292|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||.70
71093335|NCT04717557|141693875|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
71093336|NCT04717557|141693876|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
71093337|NCT04717557|141693877|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
71093338|NCT04717557|141693878|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|t-test, 2 sided|||||||>0.5
71093339|NCT04717557|141693879|SUPERIORITY||||||>|0.5|||||||Cochran-Mantel-Haenszel|||Underpowered - no statistically significant difference.||||>0.5
71093340|NCT04717557|141693880|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
71093341|NCT04717557|141693881|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
71093342|NCT04717557|141693882|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
71093343|NCT04717557|141693883|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
71093344|NCT02685735|141693948|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without gabapentin treatment group. A statistically significant result is interpreted as evidence to support that the gabapentin treatment impacts some element of change after surgery (i.e, intercept or slope).||||||0.882||||||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the gabapentin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, age, sex, pupil diameter, and catastophizing-optimism construct.||||0.882
71093345|NCT02685735|141693954|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without gabapentin treatment group. A statistically significant result is interpreted as evidence to support that the gabapentin treatment impacts some element of change after surgery (i.e, intercept or slope).||||||0.137||||||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the gabapentin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, age, sex, pupil diameter, and catastrophizing-optimism construct.||||0.137
71093346|NCT02685735|141693955|SUPERIORITY||||||<|0.0001|||||||Chi-squared|14 degrees of freedom||The null hypothesis (H0) is that modeled trajectory of change in pain intensity report after total hip or total knee arthroplasty does not differ between oral gabapentin and placebo in a manner dependent on its interaction with preferred cognitive style and pre-surgery pupil resting diameter . The alternative hypothesis (H1) is that there is a difference between the two groups which is dependent on these interactions.|A likelihood ratio test was conducted to compare these two models, conditional on the difference in the degrees of freedom in both models. A statistically significant likelihood ratio test would be interpreted as evidence that the three mechanistic predictors (Catastrophising-Optimism construct, Study Group, resting Pupil diameter) impact some aspect of the change in pain that occurs after surgery. If a statistically significant effect is observed, the individual interaction parameters will be interpreted.|||<0.0001
71093347|NCT05965427|141693956|SUPERIORITY|||||||0.097|||||||Chi-squared|||||||0.097
71093348|NCT05965427|141693957|SUPERIORITY|||||||0.005|||||||Chi-squared|||"Statistical analysis of Any of the specified clinical complications measure"||||0.005
71093349|NCT05965427|141693958|SUPERIORITY|||||||0.011|||||||Chi-squared|||||||0.011
71093350|NCT05965427|141693960|SUPERIORITY|||||||0.002|||||||Chi-squared|||"Statistical analysis relates to not presenting with skin lesions measure"||||0.002
71093351|NCT05965427|141693964|SUPERIORITY|||||||0.114|||||||Chi-squared|||"Statistical analysis relates to any drug treatment for mpox measure"||||0.114
71093352|NCT05965427|141693965|SUPERIORITY||||||<|0.001|||||||Chi-squared|||"Statistical analysis relates to any drug for complications measure"||||<0.001
71093353|NCT05965427|141693966|SUPERIORITY|"Statistical analysis relates to lesion onset measure"|||||<|0.001|||||||Chi-squared|||||||<0.001
71093354|NCT02101788|141693980|SUPERIORITY||Hazard Ratio (HR)|0.55|||||TWO_SIDED|95.0|0.28|1.07|||||Estimation of treatment effect; Trametinib vs. SOC among patients with a mutation.|||1.07|0.28|
71093355|NCT02101788|141693980|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.39|1.03|||||Estimation of treatment effect; Trametinib vs. SOC among wild-type patients.|||1.03|0.39|
71093356|NCT02101788|141693980|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.0929|TWO_SIDED|95.0|0.34|1.08|||Chi-squared||Estimation of mutation effect; mutant vs. wild-type in the SOC group.|Prognostic effect of the mutation status among patients in the SOC arm.||1.08|0.34|0.0929
71093357|NCT02101788|141693980|SUPERIORITY|||||||0.7195|||||||Chi-squared|||Predictive effect biomarker p-value||||0.7195
71093358|NCT00927472|141693987|SUPERIORITY_OR_OTHER|||||||0.0386|||||||t-test, 2 sided|||||||0.0386
71093359|NCT00927472|141693988|SUPERIORITY_OR_OTHER|||||||0.3675|||||||t-test, 2 sided|||||||0.3675
71093360|NCT00927472|141693989|SUPERIORITY_OR_OTHER|||||||0.049|||||||t-test, 2 sided|||||||0.0490
70918779|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.02||||0.7979|TWO_SIDED|95.0|0.86|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=30% reduction||1.22|0.86|0.7979
70918780|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.1||||0.2964|TWO_SIDED|95.0|0.92|1.31|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=50% reduction||1.31|0.92|0.2964
70918781|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.04||||0.695|TWO_SIDED|95.0|0.87|1.24|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=50% reduction||1.24|0.87|0.6950
71093361|NCT00927472|141693990|SUPERIORITY_OR_OTHER|||||||0.0002|||||||t-test, 2 sided|||||||0.0002
71093362|NCT00927472|141693991|SUPERIORITY_OR_OTHER|||||||0.0003|||||||t-test, 2 sided|||||||0.0003
71093363|NCT00927472|141693992|SUPERIORITY_OR_OTHER|||||||0.0012|||||||t-test, 2 sided|||||||0.0012
71093364|NCT00927472|141693993|SUPERIORITY_OR_OTHER|||||||0.3817|||||||t-test, 2 sided|||||||0.3817
71093365|NCT00927472|141693994|SUPERIORITY_OR_OTHER|||||||0.1059|||||||t-test, 2 sided|||||||0.1059
71093366|NCT00927472|141693995|SUPERIORITY_OR_OTHER|||||||0.1088|||||||t-test, 2 sided|||||||0.1088
71093367|NCT00927472|141693996|SUPERIORITY_OR_OTHER|||||||0.1527|||||||t-test, 2 sided|||||||0.1527
71093368|NCT04556097|141693997|SUPERIORITY||Rate Ratio|0.61|STANDARD_ERROR_OF_MEAN|0.35||0.05|TWO_SIDED|95.0|0.31|1.2|||Difference in differences|Difference in differences model with a negative binomial distribution and log link that provides rate ratio estimate of the relative difference.|The rate ratio is estimated for intervention patients as compared to controls.|||1.20|0.31|0.05
71093369|NCT04556097|141693998|SUPERIORITY||Mean Difference (Net)|-2.7|STANDARD_ERROR_OF_MEAN|1.95||0.05|TWO_SIDED|95.0|-6.53|1.12|||Difference in differences|Difference in differences model with a Gaussian distribution and identity link that provides linear estimate of the relative point difference.||||1.12|-6.53|0.05
71093370|NCT02516241|141694001|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0751|TWO_SIDED|98.66|0.688|1.063||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.063|0.688|0.0751
71153981|NCT00488683|141800067|SUPERIORITY_OR_OTHER||R-square|0.08||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup C||||
70918782|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.14||||0.1985|TWO_SIDED|95.0|0.93|1.38|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=70% reduction||1.38|0.93|0.1985
70918783|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.17||||0.1239|TWO_SIDED|95.0|0.96|1.42|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=70% reduction||1.42|0.96|0.1239
70918784|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.18||||0.2762|TWO_SIDED|95.0|0.88|1.58|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=90% reduction||1.58|0.88|0.2762
71031820|NCT02605395|141572324|EQUIVALENCE|The confidence intervals of logarithmically transformed ratio (Idiazole/Pariet) for AUC(0-t) to be within 80-125% to prove equivalency.|Ratio of means|96.5|||||TWO_SIDED|90.0|90.02|103.44||||||||103.44|90.02|
71031821|NCT02605395|141572325|EQUIVALENCE|The confidence intervals of logarithmically transformed ratio (Idiazole/Pariet) for AUC (0 to infinity) to be within 80-125% to prove equivalency.|Ratio of means|95.69|||||TWO_SIDED|90.0|87.06|105.17||||||||105.17|87.06|
71031822|NCT01054586|141572347|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|6.1||||0.02||95.0|1.26|29.46||Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for ART naïve. Not ART naïve is the reference group."|||29.46|1.26|0.02
71031823|NCT01054586|141572348|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.12||||0.05||95.0|1.03|16.5||Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||16.50|1.03|0.05
71031824|NCT01054586|141572348|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.62||||0.68||95.0|0.16|16.27||Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||16.27|0.16|0.68
71031825|NCT01054586|141572349|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.83||||0.17||95.0|0.65|12.36||Only variables showing an imbalance between the treatment groups (when possible) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||12.36|0.65|0.17
71031826|NCT01054586|141572349|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26||||0.85||95.0|0.12|13.33||Only variables showing an imbalance between the treatment groups (when possible) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||13.33|0.12|0.85
71031827|NCT01054586|141572350|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.2||||0.06||95.0|0.94|10.82||Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||10.82|0.94|0.06
71031828|NCT01054586|141572350|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.96||95.0|0.11|9.83||Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||9.83|0.11|0.96
71031829|NCT01054586|141572351|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||0.57||95.0|0.52|3.31||Variables showing imbalance between treatments (when possible and besides APRI score) were included. Gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin were also included, but p\>0.05.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||3.31|0.52|0.57
71031830|NCT01054586|141572351|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.28||||0.22||95.0|0.04|2.14||Variables showing imbalance between treatments (when possible and besides APRI score) were included. Gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin were also included, but p\>0.05.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||2.14|0.04|0.22
71031831|NCT01054586|141572351|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.86||||0.47||95.0|0.35|9.91||Variables showing imbalance between treatments (when possible and besides APRI score) were included. Gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin were also included, but p\>0.05.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV, Other. LPV is the reference group."|||9.91|0.35|0.47
71031832|NCT01054586|141572352|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.48||95.0|0.55|3.55||Only variables showing imbalance between treatments (when possible) were included. The following were also included, but p \> 0.05: gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||3.55|0.55|0.48
71031833|NCT01054586|141572352|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26||||0.23||95.0|0.03|2.18||Only variables showing imbalance between treatments (when possible) were included. The following were also included, but p \> 0.05: gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||2.18|0.03|0.23
70971483|NCT03548051|141449297|SUPERIORITY||Difference in Proportions|0.05|||>|0.999|TWO_SIDED|95.0|-0.58|0.65||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Fisher Exact|||The null hypothesis is that there is no difference in proportions between study arms, with a two-sided alternative.||0.65|-0.58|>0.999
70971484|NCT03548051|141449300|SUPERIORITY||Difference in Proportions|0.05|||>|0.999|TWO_SIDED|95.0|-0.58|0.65||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Fisher Exact|||The null hypothesis is that there is no difference in proportions between study arms, with a two-sided alternative.||0.65|-0.58|>0.999
70971485|NCT03548051|141449301|SUPERIORITY||||||>|0.999||||||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Log Rank|||A Log-Rank permutation test for small samples was used to test the null hypothesis that there is no difference in the time to first CDAD recurrence between treatment arms.||||>0.999
70971486|NCT02684981|141449321|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis||Statistical analysis for median change in PACT-Q2 scores from V1 to V2||||< 0.0001
70971487|NCT02684981|141449321|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis||Statistical analysis for median change in convenience PACT-Q2 scores from V1 to V3||||< 0.0001
70971488|NCT02684981|141449322|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis||Statistical analysis for median change in satisfaction PACT-Q2 scores from V1 to V2||||< 0.0001
70971489|NCT02684981|141449322|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis||Statistical analysis for median change in satisfaction PACT-Q2 scores from V1 to V3||||< 0.0001
70971490|NCT02684981|141449323|OTHER||Mean Difference (Net)|18.377|STANDARD_ERROR_OF_MEAN|0.514|<|0.001|||||||Mixed Models Analysis||The primary analysis of PACT-Q2 scores was based on the random intercept model, where the matched group is considered as a random effect, the treatment as a fixed effect and the score as the response variable.|Mean change in convenience PACT-Q2 scores between VKA and Pradaxa therapy at initiation stage (V2)||||< 0.001
71093371|NCT02516241|141694002|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.3039|TWO_SIDED|96.99|0.695|1.139||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.139|0.695|0.3039
71093372|NCT02516241|141694003|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.8637|TWO_SIDED|95.0|0.83|1.169||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.169|0.830|0.8637
71093373|NCT02516241|141694004|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0091|TWO_SIDED|95.0|0.589|0.928||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||0.928|0.589|0.0091
71093374|NCT02516241|141694005|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.7599|TWO_SIDED|95.0|0.799|1.359||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.359|0.799|0.7599
70971491|NCT02684981|141449323|OTHER||Mean Difference (Net)|23.341|STANDARD_ERROR_OF_MEAN|0.509|<|0.001|||||||Mixed Models Analysis||The primary analysis of PACT-Q2 scores was based on the random intercept model, where the matched group is considered as a random effect, the treatment as a fixed effect and the score as the response variable.|Mean change in convenience PACT-Q2 scores between VKA and Pradaxa therapy at continuation stage (V3)||||< 0.001
70971492|NCT02684981|141449324|OTHER||Mean Difference (Net)|15.884|STANDARD_ERROR_OF_MEAN|0.388|<|0.001|||||||Mixed Models Analysis||The primary analysis of PACT-Q2 scores was based on the random intercept model, where the matched group is considered as a random effect, the treatment as a fixed effect and the score as the response variable.|Mean change in satisfaction PACT-Q2 scores between VKA and Pradaxa therapy at initiation stage (V2)||||< 0.001
70971493|NCT02684981|141449324|OTHER||Mean Difference (Net)|19.011|STANDARD_ERROR_OF_MEAN|0.408|<|0.001|||||||Mixed Models Analysis||The primary analysis of PACT-Q2 scores was based on the random intercept model, where the matched group is considered as a random effect, the treatment as a fixed effect and the score as the response variable.|Mean change in satisfaction PACT-Q2 scores between VKA and Pradaxa therapy at continuation stage (V3)||||< 0.001
70971494|NCT02684981|141449332|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis||Median convenience and satisfaction PACT-Q2 scores at last assessment compared to second assessment||||< 0.001
71093375|NCT02516241|141694005|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.4424|TWO_SIDED|95.0|0.692|1.175||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|monotherapy as reference.||1.175|0.692|0.4424
71153982|NCT00488683|141800067|SUPERIORITY_OR_OTHER||R-square|0.45||||0.0436||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup W-135||||0.0436
70971495|NCT00179309|141449361|SUPERIORITY_OR_OTHER|||||||0.12|ONE_SIDED|95.0||||Multiple comparisons were not done.|Log Rank|||48 evaluable pts will be randomized in a 1:1 ratio between two arms (24 evaluable pts per arm). Using standard formulae (e.g. nQuery Advisor v5), this number was selected to provide 80% power to detect a difference between 4.2 month median progression free survival (PFS) on the docetaxel alone arm and 8 month median PFS on the arm receiving PANVAC plus docetaxel, with a one-tailed alpha=0.10,assuming 36 months accrual and an additional 12 months of follow-up after the last pt has been enrolled.||||0.12
70971496|NCT01709149|141449367|SUPERIORITY||Least squares mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.366||0.114|TWO_SIDED|95.0|-1.3|0.14|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||0.14|-1.30|0.1140
70971497|NCT01709149|141449368|SUPERIORITY||Least squares mean difference|0.48|STANDARD_ERROR_OF_MEAN|1.963||0.8083|TWO_SIDED|95.0|-3.38|4.34|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||4.34|-3.38|0.8083
70971498|NCT01709149|141449369|SUPERIORITY||Least squares mean difference|-3.4|STANDARD_ERROR_OF_MEAN|1.627||0.0372|TWO_SIDED|95.0|-6.6|-0.2|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||-0.20|-6.60|0.0372
70971499|NCT01709149|141449370|SUPERIORITY||Least squares mean difference|4.25|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|95.0|2.23|6.28|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||6.28|2.23|<0.0001
70971500|NCT01709149|141449371|SUPERIORITY||Least squares mean difference|0.75|STANDARD_ERROR_OF_MEAN|0.956||0.4328|TWO_SIDED|95.0|-1.13|2.63|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||2.63|-1.13|0.4328
70971501|NCT01709149|141449372|SUPERIORITY||Least squares mean difference|0.25|STANDARD_ERROR_OF_MEAN|4.399||0.9546|TWO_SIDED|95.0|-8.4|8.9|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||8.90|-8.40|0.9546
70971502|NCT01709149|141449373|SUPERIORITY||Least squares mean difference|1.61|STANDARD_ERROR_OF_MEAN|3.207||0.6166|TWO_SIDED|95.0|-4.7|7.91|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||7.91|-4.70|0.6166
70971503|NCT00689572|141449390|EQUIVALENCE|Mixed-effects linear regression model|Mean Difference (Final Values)|-0.09||||0.972|TWO_SIDED|95.0|-5.43|5.25|||Regression, Linear|Mixed-effects linear regression model included random intercept and slope (for temporal trend)||Difference between ondansetron and placebo groups regarding percentage of cocaine-free days (PCFD)||5.25|-5.43|0.972
70971504|NCT00689572|141449391|EQUIVALENCE|Mixed-effects linear regression model|Mean Difference (Final Values)|0.44||||0.909|TWO_SIDED|95.0|-7.08|7.95|||Regression, Linear|Mixed-effects linear regression model included random intercept and slope (for temporal trend)||Difference between ondansetron and placebo groups regarding percentage of cocaine free urines (PCFU)||7.95|-7.08|0.909
71093376|NCT02516241|141694009|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.2579|TWO_SIDED|95.0|0.931|1.304||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.304|0.931|0.2579
70971505|NCT03594227|141449413|SUPERIORITY||Mean Difference (Net)|-19.26|STANDARD_ERROR_OF_MEAN|5.02||0.011|TWO_SIDED|95.0|-33.98|-4.54||All statistical testing was two-sided and performed using a significance (alpha) level of 0.05.|Mixed Models Analysis|||The planned sample size is approximately 95 enrolled subjects with approximately 45 subjects enrolled with AT or AU. Because the primary efficacy analysis of mean percent reduction in hair loss using SALT scores is expected to be more sensitive than the SALT50 responder analysis, the power for the primary analysis is also expected to be no less than 80%.||-4.54|-33.98|0.011
70971506|NCT03594227|141449413|SUPERIORITY||Mean Difference (Final Values)|-24.08|STANDARD_ERROR_OF_MEAN|5.02||0.001|TWO_SIDED|95.0|-38.8|-9.36||All statistical testing was two-sided and performed using a significance (alpha) level of 0.05.|Mixed Models Analysis|||The planned sample size is approximately 95 enrolled subjects with approximately 45 subjects enrolled with AT or AU. Because the primary efficacy analysis of mean percent reduction in hair loss using SALT scores is expected to be more sensitive than the SALT50 responder analysis, the power for the primary analysis is also expected to be no less than 80%.||-9.36|-38.80|0.001
70971507|NCT03594227|141449413|SUPERIORITY||Mean Difference (Final Values)|-19.54|STANDARD_ERROR_OF_MEAN|5.133||0.01|TWO_SIDED|95.0|-34.41|-4.67||All statistical testing was two-sided and performed using a significance (alpha) level of 0.05.|Mixed Models Analysis|||The planned sample size is approximately 95 enrolled subjects with approximately 45 subjects enrolled with AT or AU. Because the primary efficacy analysis of mean percent reduction in hair loss using SALT scores is expected to be more sensitive than the SALT50 responder analysis, the power for the primary analysis is also expected to be no less than 80%.||-4.67|-34.41|0.010
70971508|NCT03594227|141449414|SUPERIORITY||Mean Difference (Final Values)|-19.17|STANDARD_ERROR_OF_MEAN|5.165||0.013|TWO_SIDED|95.0|-34.33|-4.02|||Mixed Models Analysis|||||-4.02|-34.33|0.013
70971509|NCT03594227|141449414|SUPERIORITY||Mean Difference (Net)|-24.53|STANDARD_ERROR_OF_MEAN|5.165||0.002|TWO_SIDED|95.0|-39.69|-9.38|||Mixed Models Analysis|||||-9.38|-39.69|0.002
71153983|NCT00488683|141800067|SUPERIORITY_OR_OTHER||R-square|0.17||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup W-135||||
70971510|NCT03594227|141449414|SUPERIORITY||Mean Difference (Net)|-19.17|STANDARD_ERROR_OF_MEAN|5.281||0.014|TWO_SIDED|95.0|-34.48|-3.86|||Mixed Models Analysis|||||-3.86|-34.48|0.014
70971511|NCT03594227|141449415|SUPERIORITY||Mean Difference (Net)|-11.29|STANDARD_ERROR_OF_MEAN|3.359||0.025|TWO_SIDED|95.0|-21.14|-1.45|||Mixed Models Analysis|||||-1.45|-21.14|0.025
70971512|NCT03594227|141449415|SUPERIORITY||Mean Difference (Net)|-15.25|STANDARD_ERROR_OF_MEAN|3.359||0.003|TWO_SIDED|95.0|-25.1|-5.4|||Mixed Models Analysis|||||-5.40|-25.10|0.003
70971513|NCT03594227|141449415|SUPERIORITY||Mean Difference (Net)|-17.55|STANDARD_ERROR_OF_MEAN|3.434|<|0.001|TWO_SIDED|95.0|-27.49|-7.6|||Mixed Models Analysis|||||-7.60|-27.49|<0.001
70971514|NCT03594227|141449416|SUPERIORITY||Mean Difference (Net)|-14.4|STANDARD_ERROR_OF_MEAN|3.599||0.008|TWO_SIDED|95.0|-24.95|-3.84|||Mixed Models Analysis|||||-3.84|-24.95|0.008
70971515|NCT03594227|141449416|SUPERIORITY||Mean Difference (Net)|-19.01|STANDARD_ERROR_OF_MEAN|3.599|<|0.001|TWO_SIDED|95.0|-29.56|-8.45|||Mixed Models Analysis|||||-8.45|-29.56|<0.001
70971516|NCT03594227|141449416|SUPERIORITY||Mean Difference (Net)|-17.52|STANDARD_ERROR_OF_MEAN|3.679||0.001|TWO_SIDED|95.0|-28.18|-6.86|||Mixed Models Analysis|||||-6.86|-28.18|0.001
70971517|NCT03594227|141449417|SUPERIORITY||Odds Ratio (OR)|4.6||||0.124|TWO_SIDED|95.0|0.7|31.8|||Mixed Models Analysis|||||31.8|0.7|0.124
71093377|NCT02516241|141694009|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.0008|TWO_SIDED|95.0|1.124|1.567||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.567|1.124|0.0008
71093378|NCT02516241|141694010|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.2395|TWO_SIDED|95.0|0.705|1.091||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.091|0.705|0.2395
71093379|NCT02516241|141694010|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.2431|TWO_SIDED|95.0|0.917|1.406||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.406|0.917|0.2431
71093380|NCT02516241|141694011|SUPERIORITY||Hazard Ratio (HR)|1.53||||0.0014|TWO_SIDED|95.0|1.177|1.99||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.990|1.177|0.0014
71093381|NCT02516241|141694011|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.6236|TWO_SIDED|95.0|0.729|1.209||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|monotherapy as reference.||1.209|0.729|0.6236
71093382|NCT02516241|141694015|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0477|TWO_SIDED|95.0|0.683|0.998||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||0.998|0.683|0.0477
71093383|NCT02516241|141694015|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.7885|TWO_SIDED|95.0|0.809|1.175||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.175|0.809|0.7885
71093384|NCT02516241|141694016|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0053|TWO_SIDED|95.0|0.549|0.901||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||0.901|0.549|0.0053
71093385|NCT02516241|141694016|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.1336|TWO_SIDED|95.0|0.651|1.059||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.059|0.651|0.1336
71093386|NCT02516241|141694017|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.8148|TWO_SIDED|95.0|0.772|1.391||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.391|0.772|0.8148
71093387|NCT02516241|141694017|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.2684|TWO_SIDED|95.0|0.636|1.134||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|monotherapy as reference.||1.134|0.636|0.2684
70918785|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.44||||0.0121|TWO_SIDED|95.0|1.08|1.91|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=90% reduction||1.91|1.08|0.0121
70918786|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8443|TWO_SIDED|95.0|0.85|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=30% reduction||1.22|0.85|0.8443
71093388|NCT02516241|141694018|SUPERIORITY||Odds Ratio (OR)|0.58||||0.0005|TWO_SIDED|95.0|0.422|0.788||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|||0.788|0.422|0.0005
71153984|NCT00488683|141800067|SUPERIORITY_OR_OTHER||R-square|0.37||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup Y||||
70918787|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8472|TWO_SIDED|95.0|0.85|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=30% reduction||1.22|0.85|0.8472
71093389|NCT02516241|141694018|SUPERIORITY||Odds Ratio (OR)|0.35|||<|0.0001|TWO_SIDED|95.0|0.253|0.485||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|||0.485|0.253|<0.0001
71093390|NCT02516241|141694019|SUPERIORITY||Odds Ratio (OR)|0.94||||0.7708|TWO_SIDED|95.0|0.639|1.394||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||1.394|0.639|0.7708
71093391|NCT02516241|141694019|SUPERIORITY||Odds Ratio (OR)|0.41|||<|0.0001|TWO_SIDED|95.0|0.268|0.61||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||0.610|0.268|<0.0001
71093392|NCT02516241|141694020|SUPERIORITY||Odds Ratio (OR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.135|0.406||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||0.406|0.135|<0.0001
71093393|NCT02516241|141694020|SUPERIORITY||Odds Ratio (OR)|0.86||||0.6195|TWO_SIDED|95.0|0.469|1.566||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|monotherapy as reference.||1.566|0.469|0.6195
71093394|NCT02516241|141694022|SUPERIORITY||Odds Ratio (OR)|0.56||||0.0002|TWO_SIDED|95.0|0.41|0.759||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|||0.759|0.410|0.0002
71093395|NCT02516241|141694022|SUPERIORITY||Odds Ratio (OR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.267|0.5||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|||0.500|0.267|<0.0001
71093396|NCT02516241|141694023|SUPERIORITY||Odds Ratio (OR)|0.87||||0.4959|TWO_SIDED|95.0|0.59|1.291||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||1.291|0.590|0.4959
71093397|NCT02516241|141694023|SUPERIORITY||Odds Ratio (OR)|0.46||||0.0001|TWO_SIDED|95.0|0.305|0.679||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||0.679|0.305|0.0001
71093398|NCT02516241|141694024|SUPERIORITY||Odds Ratio (OR)|0.27|||<|0.0001|TWO_SIDED|95.0|0.16|0.448||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||0.448|0.160|<0.0001
71153985|NCT00488683|141800067|SUPERIORITY_OR_OTHER||R-square|0.07||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup Y||||
70918788|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.01||||0.898|TWO_SIDED|95.0|0.85|1.21|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=50% reduction||1.21|0.85|0.8980
70918789|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9385|TWO_SIDED|95.0|0.83|1.19|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=50% reduction||1.19|0.83|0.9385
70971518|NCT03594227|141449417|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.079|TWO_SIDED|95.0|0.8|38.3|||Mixed Models Analysis|||||38.3|0.8|0.079
70971519|NCT03594227|141449417|SUPERIORITY||Mean Difference (Final Values)|3.9||||0.177|TWO_SIDED|95.0|0.5|27.7|||Mixed Models Analysis|||||27.7|0.5|0.177
71093399|NCT02516241|141694024|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8074|TWO_SIDED|95.0|0.623|1.836||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|monotherapy as reference.||1.836|0.623|0.8074
71093400|NCT02516241|141694025|SUPERIORITY||Odds Ratio (OR)|0.59||||0.0008|TWO_SIDED|95.0|0.432|0.802||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|||0.802|0.432|0.0008
70971520|NCT03594227|141449418|SUPERIORITY||Odds Ratio (OR)|4.6||||0.124|TWO_SIDED|95.0|0.7|31.8|||Mixed Models Analysis|||||31.8|0.7|0.124
70971521|NCT03594227|141449418|SUPERIORITY||Odds Ratio (OR)|5.6||||0.079|TWO_SIDED|95.0|0.8|38.3|||Mixed Models Analysis|||||38.3|0.8|0.079
71093401|NCT02516241|141694025|SUPERIORITY||Odds Ratio (OR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.27|0.512||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|||0.512|0.270|<0.0001
71093402|NCT02516241|141694026|SUPERIORITY||Odds Ratio (OR)|0.94||||0.7717|TWO_SIDED|95.0|0.639|1.394||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||1.394|0.639|0.7717
71093403|NCT02516241|141694026|SUPERIORITY||Odds Ratio (OR)|0.46||||0.0001|TWO_SIDED|95.0|0.303|0.682||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||0.682|0.303|0.0001
71093404|NCT02516241|141694027|SUPERIORITY||Odds Ratio (OR)|0.26|||<|0.0001|TWO_SIDED|95.0|0.151|0.439||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||0.439|0.151|<0.0001
71093405|NCT02516241|141694027|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9692|TWO_SIDED|95.0|0.556|1.759||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|monotherapy as reference.||1.759|0.556|0.9692
71093406|NCT02516241|141694035|SUPERIORITY||Mean Difference (Final Values)|1.5||||0.1617|TWO_SIDED|95.0|-0.6|3.59||MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||NFBLSI- 18 score (Average overall visits)||3.59|-0.6|0.1617
71093407|NCT02516241|141694035|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.0578|TWO_SIDED|95.0|-0.07|4.29||MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||NFBLSI- 18 score (Average overall visits)||4.29|-0.07|0.0578
71093408|NCT02516241|141694035|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.2003|TWO_SIDED|95.0|-0.91|4.32||MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL TOI (Average overall visits)||4.32|-0.91|0.2003
71093409|NCT02516241|141694035|SUPERIORITY||Mean Difference (Final Values)|3.3||||0.0178|TWO_SIDED|95.0|0.57|6.0||MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL TOI (Average overall visits)||6.00|0.57|0.0178
71153986|NCT01274338|141800086|SUPERIORITY|||||||0.065||||||This design provides at least 80% power at a one sided type I error rate of 0.003.|Log Rank|Stratified logrank test||This study has a two-step hierarchical approach. In the first step, the low-dose Ipi (LIP) will be compared with HDI. If the low-dose Ipi is significantly better than HDI, then the high-dose Ipi will be compared with HDI as a second step. When comparing the two investigational treatment groups, the primary comparison will be an intent to treat analysis of recurrence free survival (RFS; First Co-primary Endpoint) and overall survival (OS; Second Co-primary Endpoint).||||0.065
70971522|NCT03594227|141449418|SUPERIORITY||Odds Ratio (OR)|3.9||||0.177|TWO_SIDED|95.0|0.5|27.7|||Mixed Models Analysis|||||27.7|0.5|0.177
70971523|NCT03594227|141449419|SUPERIORITY|||||||0.471|||||||Wilcoxon (Mann-Whitney)|||||||0.471
70971524|NCT03594227|141449419|SUPERIORITY|||||||0.457|||||||Wilcoxon (Mann-Whitney)|||||||0.457
70971525|NCT03594227|141449419|SUPERIORITY|||||||0.367|||||||Wilcoxon (Mann-Whitney)|||||||0.367
70971526|NCT03594227|141449420|SUPERIORITY|||||||0.187|||||||Wilcoxon (Mann-Whitney)|||||||0.187
70971527|NCT03594227|141449420|SUPERIORITY|||||||0.375|||||||Wilcoxon (Mann-Whitney)|||||||0.375
70971528|NCT03594227|141449420|SUPERIORITY|||||||0.581|||||||Wilcoxon (Mann-Whitney)|||||||0.581
70971529|NCT03594227|141449421|SUPERIORITY|||||||0.444|||||||Wilcoxon (Mann-Whitney)|||||||0.444
71093410|NCT02516241|141694035|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.3765|TWO_SIDED|95.0|-1.96|5.17||MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL Total score (Average overall visits)||5.17|-1.96|0.3765
71093411|NCT02516241|141694035|SUPERIORITY||Mean Difference (Final Values)|4.1||||0.03|TWO_SIDED|95.0|0.4|7.81||MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL Total score (Average overall visits)||7.81|0.40|0.0300
70971530|NCT03594227|141449421|SUPERIORITY|||||||0.861|||||||Wilcoxon (Mann-Whitney)|||||||0.861
70971531|NCT03594227|141449421|SUPERIORITY|||||||0.182|||||||Wilcoxon (Mann-Whitney)|||||||0.182
70971532|NCT03594227|141449422|SUPERIORITY|||||||0.258|||||||Wilcoxon (Mann-Whitney)|||||||0.258
70971533|NCT03594227|141449422|SUPERIORITY|||||||0.263|||||||Wilcoxon (Mann-Whitney)|||||||0.263
70971534|NCT03594227|141449422|SUPERIORITY|||||||0.101|||||||Wilcoxon (Mann-Whitney)|||||||0.101
70971535|NCT03594227|141449423|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||||||>0.999
70971536|NCT03594227|141449423|SUPERIORITY|||||||0.277|||||||Wilcoxon (Mann-Whitney)|||||||0.277
70971537|NCT03594227|141449423|SUPERIORITY|||||||0.159|||||||Wilcoxon (Mann-Whitney)|||||||0.159
70971538|NCT03594227|141449424|SUPERIORITY|||||||0.407|||||||Wilcoxon (Mann-Whitney)|||||||0.407
71093412|NCT02516241|141694036|SUPERIORITY||Mean Difference (Final Values)|1.9||||0.1373|TWO_SIDED|95.0|-0.6|4.36||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||NFBLSI- 18 score (Average overall visits)||4.36|-0.6|0.1373
70971539|NCT03594227|141449424|SUPERIORITY|||||||0.894|||||||Wilcoxon (Mann-Whitney)|||||||0.894
70971540|NCT03594227|141449424|SUPERIORITY|||||||0.179|||||||Wilcoxon (Mann-Whitney)|||||||0.179
70971541|NCT03594227|141449425|SUPERIORITY|||||||0.691|||||||Wilcoxon (Mann-Whitney)|||||||0.691
70971542|NCT03594227|141449425|SUPERIORITY|||||||0.521|||||||Wilcoxon (Mann-Whitney)|||||||0.521
70971543|NCT03594227|141449425|SUPERIORITY|||||||0.262|||||||Wilcoxon (Mann-Whitney)|||||||0.262
70971544|NCT03594227|141449426|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
70971545|NCT03594227|141449426|SUPERIORITY|||||||0.154|||||||Wilcoxon (Mann-Whitney)|||||||0.154
71093413|NCT02516241|141694036|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.0034|TWO_SIDED|95.0|1.26|6.27||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||NFBLSI- 18 score (Average overall visits)||6.27|1.26|0.0034
71093414|NCT02516241|141694036|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.1774|TWO_SIDED|95.0|-1.0|5.39||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL TOI (Average overall visits)||5.39|-1.00|0.1774
71093415|NCT02516241|141694036|SUPERIORITY||Mean Difference (Final Values)|5.4||||0.0011|TWO_SIDED|95.0|2.19|8.65||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL TOI (Average overall visits)||8.65|2.19|0.0011
71093416|NCT02516241|141694036|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.3494|TWO_SIDED|95.0|-2.27|6.38||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL Total score (Average overall visits)||6.38|-2.27|0.3494
70971546|NCT03594227|141449426|SUPERIORITY|||||||0.289|||||||Wilcoxon (Mann-Whitney)|||||||0.289
70971547|NCT03594227|141449427|SUPERIORITY|||||||0.073|||||||Wilcoxon (Mann-Whitney)|||||||0.073
70971548|NCT03594227|141449427|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||0.660
70971549|NCT03594227|141449427|SUPERIORITY|||||||0.704|||||||Wilcoxon (Mann-Whitney)|||||||0.704
70971550|NCT03594227|141449428|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||||||>0.999
71093417|NCT02516241|141694036|SUPERIORITY||Mean Difference (Final Values)|7.3||||0.0011|TWO_SIDED|95.0|2.96|11.71||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL Total score (Average overall visits)||11.71|2.96|0.0011
71093418|NCT02516241|141694037|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.3865|TWO_SIDED|95.0|-4.35|1.69||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||NFBLSI- 18 score (Average overall visits)||1.69|-4.35|0.3865
70971551|NCT03594227|141449428|SUPERIORITY|||||||0.911|||||||Wilcoxon (Mann-Whitney)|||||||0.911
70971552|NCT03594227|141449428|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.110
70971553|NCT03594227|141449429|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.430
70971554|NCT03594227|141449429|SUPERIORITY|||||||0.288|||||||Wilcoxon (Mann-Whitney)|||||||0.288
70971555|NCT03594227|141449429|SUPERIORITY|||||||0.582|||||||Wilcoxon (Mann-Whitney)|||||||0.582
70971556|NCT03594227|141449430|SUPERIORITY|||||||0.194|||||||Wilcoxon (Mann-Whitney)|||||||0.194
70971557|NCT03594227|141449430|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||||||>0.999
70971558|NCT03594227|141449430|SUPERIORITY|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
70971559|NCT03594227|141449431|SUPERIORITY|||||||0.248|||||||Wilcoxon (Mann-Whitney)|||||||0.248
70971560|NCT03594227|141449431|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.150
70971561|NCT03594227|141449431|SUPERIORITY|||||||0.546|||||||Wilcoxon (Mann-Whitney)|||||||0.546
70971562|NCT03594227|141449432|SUPERIORITY|||||||0.341|||||||Wilcoxon (Mann-Whitney)|||||||0.341
70971563|NCT03594227|141449432|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||||||>0.999
70971564|NCT03594227|141449432|SUPERIORITY|||||||0.068|||||||Wilcoxon (Mann-Whitney)|||||||0.068
70971565|NCT03594227|141449434|SUPERIORITY|||||||0.098|||||||Wilcoxon (Mann-Whitney)|||||||0.098
70971566|NCT03594227|141449434|SUPERIORITY|||||||0.082|||||||Wilcoxon (Mann-Whitney)|||||||0.082
70971567|NCT03594227|141449434|SUPERIORITY|||||||0.313|||||||Wilcoxon (Mann-Whitney)|||||||0.313
70971568|NCT03594227|141449435|SUPERIORITY|||||||0.883|||||||Wilcoxon (Mann-Whitney)|||||||0.883
70971569|NCT03594227|141449435|SUPERIORITY|||||||0.954|||||||Wilcoxon (Mann-Whitney)|||||||0.954
70971570|NCT03594227|141449435|SUPERIORITY|||||||0.295|||||||Wilcoxon (Mann-Whitney)|||||||0.295
70971571|NCT03594227|141449436|SUPERIORITY|||||||0.361|||||||Wilcoxon (Mann-Whitney)|||||||0.361
70971572|NCT03594227|141449436|SUPERIORITY|||||||0.182|||||||Wilcoxon (Mann-Whitney)|||||||0.182
70971573|NCT03594227|141449436|SUPERIORITY|||||||0.815|||||||Wilcoxon (Mann-Whitney)|||||||0.815
70971574|NCT03594227|141449437|SUPERIORITY|||||||0.522|||||||Wilcoxon (Mann-Whitney)|||||||0.522
70971575|NCT03594227|141449437|SUPERIORITY|||||||0.104|||||||Wilcoxon (Mann-Whitney)|||||||0.104
70971576|NCT03594227|141449437|SUPERIORITY|||||||0.414|||||||Wilcoxon (Mann-Whitney)|||||||0.414
70971577|NCT03594227|141449438|SUPERIORITY||Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.93||0.882|TWO_SIDED|95.0|-2.53|2.94|||Mixed Models Analysis|||||2.94|-2.53|0.882
70971578|NCT03594227|141449438|SUPERIORITY||Mean Difference (Net)|-3.58|STANDARD_ERROR_OF_MEAN|0.93||0.011|TWO_SIDED|95.0|-6.31|-0.84|||Mixed Models Analysis|||||-0.84|-6.31|0.011
70971579|NCT03594227|141449438|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.951||0.999|TWO_SIDED|95.0|-2.76|2.76|||Mixed Models Analysis|||||2.76|-2.76|0.999
70971580|NCT03594227|141449439|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.270
71093419|NCT02516241|141694037|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.284|TWO_SIDED|95.0|-5.05|1.49||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||NFBLSI- 18 score (Average overall visits)||1.49|-5.05|0.2840
71093420|NCT02516241|141694037|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.297|TWO_SIDED|95.0|-5.41|1.66||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL TOI (Average overall visits)||1.66|-5.41|0.2970
71093421|NCT02516241|141694037|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.3026|TWO_SIDED|95.0|-5.85|1.83||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL TOI (Average overall visits)||1.83|-5.85|0.3026
71093422|NCT02516241|141694037|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.3168|TWO_SIDED|95.0|-7.29|2.38||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL Total score (Average overall visits)||2.38|-7.29|0.3168
71093423|NCT02516241|141694037|SUPERIORITY||Mean Difference (Final Values)|-3.3||||0.2179|TWO_SIDED|95.0|-8.51|1.96||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL Total score (Average overall visits)||1.96|-8.51|0.2179
71093424|NCT02516241|141694038|SUPERIORITY||Odds Ratio (OR)|1.4||||0.2419|TWO_SIDED|95.0|0.8|2.6||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood|Patients with improvement in fatigue||2.6|0.8|0.2419
71093425|NCT02516241|141694038|SUPERIORITY||Odds Ratio (OR)|1.5||||0.1553|TWO_SIDED|95.0|0.9|2.8||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patients with improvement in fatigue||2.8|0.9|0.1553
71093426|NCT02516241|141694038|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0003|TWO_SIDED|95.0|1.4|2.8||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patient with deterioration in pain||2.8|1.4|0.0003
71093427|NCT02516241|141694038|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0148|TWO_SIDED|95.0|1.1|2.3||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patient with deterioration in pain||2.3|1.1|0.0148
71093428|NCT02516241|141694039|SUPERIORITY||Odds Ratio (OR)|1.6||||0.2473|TWO_SIDED|95.0|0.7|3.4||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patients with improvement in fatigue||3.4|0.7|0.2473
71093429|NCT02516241|141694039|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0148|TWO_SIDED|95.0|0.8|3.8||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patients with improvement in fatigue||3.8|0.8|0.0148
71093430|NCT02516241|141694039|SUPERIORITY||Odds Ratio (OR)|1.9||||0.009|TWO_SIDED|95.0|1.2|3.0||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood|Patient with deterioration in pain||3.0|1.2|0.0090
70971581|NCT03594227|141449439|SUPERIORITY|||||||0.319|||||||Wilcoxon (Mann-Whitney)|||||||0.319
70971582|NCT03594227|141449439|SUPERIORITY|||||||0.094|||||||Wilcoxon (Mann-Whitney)|||||||0.094
70971583|NCT03594227|141449440|SUPERIORITY|||||||0.584|||||||Wilcoxon (Mann-Whitney)|||||||0.584
70971584|NCT03594227|141449440|SUPERIORITY|||||||0.287|||||||Wilcoxon (Mann-Whitney)|||||||0.287
70971585|NCT03594227|141449440|SUPERIORITY|||||||0.144|||||||Wilcoxon (Mann-Whitney)|||||||0.144
70971586|NCT03594227|141449441|SUPERIORITY|||||||0.341|||||||Wilcoxon (Mann-Whitney)|||||||0.341
70971587|NCT03594227|141449441|SUPERIORITY|||||||0.203|||||||Wilcoxon (Mann-Whitney)|||||||0.203
70971588|NCT03594227|141449441|SUPERIORITY|||||||0.327|||||||Wilcoxon (Mann-Whitney)|||||||0.327
70971589|NCT03594227|141449442|SUPERIORITY|||||||0.827|||||||Wilcoxon (Mann-Whitney)|||||||0.827
71093431|NCT02516241|141694039|SUPERIORITY||Odds Ratio (OR)|1.4||||0.151|TWO_SIDED|95.0|0.9|2.3||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patient with deterioration in pain||2.3|0.9|0.1510
70918790|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.08||||0.4261|TWO_SIDED|95.0|0.89|1.32|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=70% reduction||1.32|0.89|0.4261
70918791|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.07||||0.525|TWO_SIDED|95.0|0.88|1.3|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=70% reduction||1.30|0.88|0.5250
70918792|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.08||||0.6273|TWO_SIDED|95.0|0.8|1.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=90% reduction||1.45|0.80|0.6273
70918793|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.43||||0.0132|TWO_SIDED|95.0|1.08|1.9|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=90% reduction||1.90|1.08|0.0132
70918794|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9095|TWO_SIDED|95.0|0.83|1.18|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=30% reduction||1.18|0.83|0.9095
70918795|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|0.94||||0.5098|TWO_SIDED|95.0|0.79|1.12|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=30% reduction||1.12|0.79|0.5098
70918796|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.07||||0.4488|TWO_SIDED|95.0|0.9|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=50% reduction||1.28|0.90|0.4488
70918797|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9757|TWO_SIDED|95.0|0.83|1.19|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=50% reduction||1.19|0.83|0.9757
70918798|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.14||||0.1843|TWO_SIDED|95.0|0.94|1.39|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=70% reduction||1.39|0.94|0.1843
70918799|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.08||||0.4356|TWO_SIDED|95.0|0.89|1.32|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=70% reduction||1.32|0.89|0.4356
70918800|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.08||||0.6342|TWO_SIDED|95.0|0.8|1.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=90% reduction||1.45|0.80|0.6342
70918801|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.29||||0.081|TWO_SIDED|95.0|0.97|1.73|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=90% reduction||1.73|0.97|0.0810
70918802|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|0.96||||0.6527|TWO_SIDED|95.0|0.8|1.15|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=30% reduction||1.15|0.80|0.6527
70971590|NCT03594227|141449442|SUPERIORITY|||||||0.742|||||||Wilcoxon (Mann-Whitney)|||||||0.742
70918803|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|0.92||||0.3857|TWO_SIDED|95.0|0.77|1.1|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=30% reduction||1.10|0.77|0.3857
70918804|NCT02528188|141328694|SUPERIORITY||Odds Ratio, log|1.06||||0.528|TWO_SIDED|95.0|0.89|1.27|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=50% reduction||1.27|0.89|0.5280
70971591|NCT03594227|141449442|SUPERIORITY|||||||0.462|||||||Wilcoxon (Mann-Whitney)|||||||0.462
70971592|NCT03594227|141449443|SUPERIORITY|||||||0.836|||||||Wilcoxon (Mann-Whitney)|||||||0.836
70971593|NCT03594227|141449443|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.540
71093432|NCT02516241|141694040|SUPERIORITY||Odds Ratio (OR)|1.2||||0.6763|TWO_SIDED|95.0|0.5|3.2||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patients with improvement in fatigue||3.2|0.5|0.6763
70918805|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|0.94||||0.5355|TWO_SIDED|95.0|0.79|1.13|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=50% reduction||1.13|0.79|0.5355
70918806|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7732|TWO_SIDED|95.0|0.84|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=70% reduction||1.26|0.84|0.7732
70918807|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9397|TWO_SIDED|95.0|0.82|1.23|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=70% reduction||1.23|0.82|0.9397
70918808|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9044|TWO_SIDED|95.0|0.75|1.39|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=90% reduction||1.39|0.75|0.9044
70918809|NCT02528188|141328694|SUPERIORITY||Odds Ratio (OR)|1.16||||0.3193|TWO_SIDED|95.0|0.86|1.57|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=90% reduction||1.57|0.86|0.3193
70918810|NCT02528188|141328696|SUPERIORITY||Odds Ratio (OR)|1.22||||0.1772|TWO_SIDED|95.0|0.91|1.62|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.62|0.91|0.1772
70918811|NCT02528188|141328696|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0154|TWO_SIDED|95.0|1.07|1.89|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.89|1.07|0.0154
70918812|NCT02528188|141328696|SUPERIORITY||Odds Ratio (OR)|1.4||||0.0105|TWO_SIDED|95.0|1.08|1.81|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.81|1.08|0.0105
70918813|NCT02528188|141328696|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0002|TWO_SIDED|95.0|1.26|2.1|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||2.10|1.26|0.0002
70918814|NCT02528188|141328696|SUPERIORITY||Odds Ratio (OR)|1.11||||0.4007|TWO_SIDED|95.0|0.87|1.43|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.43|0.87|0.4007
70918815|NCT02528188|141328696|SUPERIORITY||Odds Ratio (OR)|1.37||||0.0116|TWO_SIDED|95.0|1.07|1.75|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.75|1.07|0.0116
70918816|NCT02528188|141328696|SUPERIORITY||Odds Ratio (OR)|0.95||||0.6279|TWO_SIDED|95.0|0.76|1.18|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.18|0.76|0.6279
70918817|NCT02528188|141328696|SUPERIORITY||Odds Ratio (OR)|1.09||||0.4674|TWO_SIDED|95.0|0.87|1.35|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.35|0.87|0.4674
70918818|NCT02528188|141328696|SUPERIORITY||Odds Ratio (OR)|0.89||||0.3135|TWO_SIDED|95.0|0.71|1.12|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.12|0.71|0.3135
70918819|NCT02528188|141328696|SUPERIORITY||Odds Ratio (OR)|1.04||||0.7581|TWO_SIDED|95.0|0.83|1.3|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.30|0.83|0.7581
70918820|NCT02528188|141328696|SUPERIORITY||Odds Ratio (OR)|0.92||||0.4504|TWO_SIDED|95.0|0.73|1.15|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.15|0.73|0.4504
70918821|NCT02528188|141328696|SUPERIORITY||Odds Ratio (OR)|0.88||||0.2629|TWO_SIDED|95.0|0.7|1.1|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.10|0.70|0.2629
70971594|NCT03594227|141449443|SUPERIORITY|||||||0.672|||||||Wilcoxon (Mann-Whitney)|||||||0.672
70971595|NCT03594227|141449444|SUPERIORITY|||||||0.469|||||||Wilcoxon (Mann-Whitney)|||||||0.469
70971596|NCT03594227|141449444|SUPERIORITY|||||||0.219|||||||Wilcoxon (Mann-Whitney)|||||||0.219
70971597|NCT03594227|141449444|SUPERIORITY|||||||0.196|||||||Wilcoxon (Mann-Whitney)|||||||0.196
70971598|NCT00790907|141449445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.267|TWO_SIDED|95.0|0.54|1.19|||Regression, Logistic|||||1.19|0.54|0.267
70971599|NCT01888640|141449453|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.008|TWO_SIDED|95.0|-1.8|-0.2||To account for multiple tests involving pairwise treatment group comparisons, p-values were adjusted using Bonferroni's method|Linear mixed models for repeated measure|||Visit 2-Visit 3||-0.2|-1.8|0.008
70971600|NCT01888640|141449453|SUPERIORITY||Mean Difference (Final Values)|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-1.0|-2.6|<0.0001
70971601|NCT01888640|141449454|SUPERIORITY||Mean Difference (Net)|-1.3||||0.002|TWO_SIDED|95.0|-2.2|-0.4|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.4|-2.2|0.002
70971602|NCT01888640|141449454|SUPERIORITY||Mean Difference (Final Values)|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.8|-1.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-1.0|-2.8|<0.0001
70971603|NCT01888640|141449455|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.0006|TWO_SIDED|95.0|-2.1|-0.4|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.4|-2.1|0.0006
70971604|NCT01888640|141449455|SUPERIORITY||Mean Difference (Final Values)|-1.4|||<|0.0001|TWO_SIDED|95.0|-2.2|-0.6|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.6|-2.2|<0.0001
70971605|NCT01888640|141449456|SUPERIORITY||Mean Difference (Final Values)|-1.4||||0.001|TWO_SIDED|95.0|-2.4|-0.4|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.4|-2.4|0.001
70971606|NCT01888640|141449456|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.9|-0.9|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.9|-2.9|<0.0001
70971607|NCT01888640|141449457|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.011|TWO_SIDED|95.0|-2.2|-0.2|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.2|-2.2|0.011
70971608|NCT01888640|141449457|SUPERIORITY||Mean Difference (Final Values)|-2.0|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-1.0|-3.0|<0.0001
70971609|NCT01888640|141449458|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.016|TWO_SIDED|95.0|-2.2|-0.1|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.1|-2.2|0.016
70971610|NCT01888640|141449458|SUPERIORITY||Mean Difference (Final Values)|-1.57||||0.0002|TWO_SIDED|95.0|-2.6|-0.6|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.6|-2.6|0.0002
70971611|NCT01888640|141449459|SUPERIORITY||Mean Difference (Final Values)|-5.0||||0.074|TWO_SIDED|95.0|-10.4|0.3|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||0.3|-10.4|0.074
70971612|NCT01888640|141449459|SUPERIORITY||Mean Difference (Final Values)|-7.1||||0.005|TWO_SIDED|95.0|-12.4|-1.8|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-1.8|-12.4|0.005
70971613|NCT01888640|141449460|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.018|TWO_SIDED|95.0|-1.7|-0.1|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.1|-1.7|0.018
70971614|NCT01888640|141449460|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.0006|TWO_SIDED|95.0|-1.9|-0.4|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.4|-1.9|0.0006
70971615|NCT01888640|141449461|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.043|TWO_SIDED|95.0|-1.3|-0.01|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.01|-1.3|0.043
70971616|NCT01888640|141449461|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.048|TWO_SIDED|95.0|-1.3|0.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.0|-1.3|0.048
70971617|NCT01888640|141449462|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.036|TWO_SIDED|95.0|-1.0|0.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.0|-1.0|0.036
70971618|NCT01888640|141449462|SUPERIORITY||Mean Difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.4|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.4|-1.4|<0.0001
70971619|NCT01888640|141449463|SUPERIORITY||Mean Difference (Final Values)|-0.4|||>|0.99|TWO_SIDED|95.0|-2.3|1.5|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||1.5|-2.3|>0.99
70971620|NCT01888640|141449463|SUPERIORITY||Mean Difference (Final Values)|-0.6|||>|0.99|TWO_SIDED|95.0|-2.4|1.3|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||1.3|-2.4|>0.99
70971621|NCT01888640|141449464|SUPERIORITY||Mean Difference (Final Values)|1.1|||>|0.99|TWO_SIDED|95.0|-1.9|4.1|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||4.1|-1.9|>0.99
70971622|NCT01888640|141449464|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.17|TWO_SIDED|95.0|-0.6|5.3|||Linear mixed models for repeated measure|||||5.3|-0.6|0.17
70971623|NCT01888640|141449465|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.36|TWO_SIDED|95.0|-0.7|3.1|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||3.1|-0.7|0.36
70971624|NCT01888640|141449465|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.58|TWO_SIDED|95.0|-0.8|2.8|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||2.8|-0.8|0.58
70971625|NCT01888640|141449466|SUPERIORITY||Mean Difference (Final Values)|19.0|||>|0.99|TWO_SIDED|95.0|-58.0|96.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||96|-58|>0.99
70971626|NCT01888640|141449466|SUPERIORITY||Mean Difference (Final Values)|42.0|||>|0.99|TWO_SIDED|95.0|-34.0|117.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||117|-34|>0.99
70971627|NCT01888640|141449467|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.96|TWO_SIDED|95.0|-0.2|0.7|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||0.7|-0.2|0.96
70971628|NCT01888640|141449467|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.008|TWO_SIDED|95.0|0.1|1.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||1.0|0.1|0.008
70971629|NCT01888640|141449468|SUPERIORITY||||||>|0.99|||||||Linear mixed models for repeated measure|||Visit 2 to Visit 3||||>0.99
70971630|NCT01888640|141449468|SUPERIORITY||||||>|0.99|||||||Linear mixed models for repeated measure|||Visit 2 to Visit 3||||>0.99
70971631|NCT00960843|141449495|SUPERIORITY_OR_OTHER|||||||0.052||95.0|||||t-test, 2 sided|||Null hypothesis was no difference between arms. Original power calculation specified 24 per group and this was achieved under initial randomization. However, due to failure to follow protocol specified adjustment criteria, pressure and weight data from one site had to be excluded.||||0.0520
70971632|NCT00960843|141449496|SUPERIORITY_OR_OTHER|||||||0.0225||95.0|||||t-test, 2 sided|||||||0.0225
70971633|NCT00960843|141449497|SUPERIORITY_OR_OTHER|||||||0.0193||95.0|||||t-test, 2 sided|||||||0.0193
70918822|NCT02528188|141328696|SUPERIORITY||Odds Ratio (OR)|0.95||||0.6763|TWO_SIDED|95.0|0.75|1.2|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.20|0.75|0.6763
70918823|NCT02528188|141328696|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9456|TWO_SIDED|95.0|0.8|1.27|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.27|0.80|0.9456
70918824|NCT02528188|141328696|SUPERIORITY||Odds Ratio (OR)|0.96||||0.752|TWO_SIDED|95.0|0.76|1.22|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.22|0.76|0.7520
70918825|NCT02528188|141328696|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9981|TWO_SIDED|95.0|0.79|1.26|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.26|0.79|0.9981
70918826|NCT02528188|141328696|SUPERIORITY||Odds Ratio (OR)|0.93||||0.5284|TWO_SIDED|95.0|0.74|1.17|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.17|0.74|0.5284
70918827|NCT02528188|141328696|SUPERIORITY||Odds Ratio (OR)|0.89||||0.322|TWO_SIDED|95.0|0.7|1.12|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.12|0.70|0.3220
70918828|NCT02528188|141328697|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.06||0.112|TWO_SIDED|95.0|-0.02|0.2|||ANCOVA|||Week 1: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.20|-0.02|0.1120
70918829|NCT02528188|141328697|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.9686|TWO_SIDED|95.0|-0.11|0.11|||ANCOVA|||Week 1: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.11|-0.11|0.9686
70918830|NCT02528188|141328697|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.08||0.1589|TWO_SIDED|95.0|-0.25|0.04|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.04|-0.25|0.1589
70918831|NCT02528188|141328697|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.08||0.472|TWO_SIDED|95.0|-0.2|0.09|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.09|-0.20|0.4720
70918832|NCT02528188|141328697|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.08||0.032|TWO_SIDED|95.0|-0.33|-0.01|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.01|-0.33|0.0320
70918833|NCT02528188|141328697|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.08||0.3336|TWO_SIDED|95.0|-0.24|0.08|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.08|-0.24|0.3336
70918834|NCT02528188|141328697|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.09||0.0005|TWO_SIDED|95.0|-0.47|-0.13|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.13|-0.47|0.0005
70918835|NCT02528188|141328697|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.09||0.0001|TWO_SIDED|95.0|-0.5|-0.16|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.16|-0.50|0.0001
70971634|NCT01181011|141449508|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|gMean Ratio|109.22|STANDARD_ERROR_OF_MEAN|1.06||0.0107||90.0|99.45|119.95||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA|||||119.95|99.45|0.0107
71153987|NCT01274338|141800087|SUPERIORITY|This design will provide 80% power to detect the difference between the two arms at a one-sided type I error rate of 0.022.||||||0.044|||||||Log Rank|Stratified logrank test||This study has a two-step hierarchical approach. In the first step, the low-dose Ipi (LIP) will be compared with HDI. If the low-dose Ipi is significantly better than HDI, then the high-dose Ipi will be compared with HDI as a second step. When comparing the two investigational treatment groups, the primary comparison will be an intent to treat analysis of recurrence free survival (RFS; First Co-primary Endpoint) and overall survival (OS; Second Co-primary Endpoint).||||0.044
70971635|NCT01181011|141449509|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|gMean Ratio|109.84|STANDARD_ERROR_OF_MEAN|1.06||0.0139|TWO_SIDED|90.0|99.96|120.71||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA|||||120.71|99.96|0.0139
70971636|NCT01181011|141449510|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|gMean Ratio|97.57|STANDARD_ERROR_OF_MEAN|1.09||0.0126|TWO_SIDED|90.0|84.643|112.472||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA|||||112.472|84.643|0.0126
70971637|NCT01181011|141449511|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|gMean Ratio|109.7|STANDARD_ERROR_OF_MEAN|1.04||0.0011|TWO_SIDED|90.0|102.87|117.07||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA|||||117.07|102.87|0.0011
70971638|NCT01181011|141449512|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|gMean Ratio|108.8|STANDARD_ERROR_OF_MEAN|1.04||0.0006|TWO_SIDED|95.0|102.1|116.0||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA|||||116.0|102.1|0.0006
70971639|NCT01181011|141449513|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|gMean Ratio|106.7|STANDARD_ERROR_OF_MEAN|1.03||0|TWO_SIDED|90.0|100.9|112.9||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA|||||112.9|100.9|0.000
70971640|NCT01223703|141449550|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|The analysis was done following an intention-to-treat approach by means of the unpaired student t test or Wilcoxon rank sum test as appropriated.||"null hypothesis is no difference n3 PUFA administration and placebo. To demonstrate an effect size of 0.5 in LVEF, a sample of 65 patients in each group was calculated to have 80% power to detect such 0.5 effect size with alpha=0.05 (2-tailed) at the Student t test.~for unpaired data."||||< 0.05
70971641|NCT01223703|141449551|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|The analysis was done following an intention-to-treat approach by means of the unpaired student t test or Wilcoxon rank sum test as appropriated.||||||< 0.05
70971642|NCT00784654|141449554|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||< 0.001
70971643|NCT00784654|141449555|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
70971644|NCT00784654|141449556|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.6|||<|0.001|TWO_SIDED|95.0|-15.4|-9.8|||ANCOVA|||||-9.8|-15.4|<0.001
70971645|NCT00784654|141449559|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
70971646|NCT00784654|141449563|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 1 sided|||||||<0.001
70971647|NCT00784654|141449564|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.5|||<|0.001|TWO_SIDED|95.0|3.5|9.5|||ANCOVA|||||9.5|3.5|<0.001
70971648|NCT00784654|141449565|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 1 sided|||||||<0.001
70971649|NCT00784654|141449566|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|||<|0.001|TWO_SIDED|95.0|-0.26|-0.11|||ANCOVA|||||-0.11|-0.26|<0.001
70971650|NCT00784654|141449569|SUPERIORITY_OR_OTHER_LEGACY|||||||0.726||95.0|||||Cochran-Mantel-Haenszel|||||||0.726
70971651|NCT01180660|141449572|SUPERIORITY_OR_OTHER||Median Difference (Net)|19.0||||0.01|TWO_SIDED|95.0|3.0|27.0|||Regression, Linear|||A sample size of 22 subjects per group was estimated to achieve 90% power to detect a 16 point difference in the aggregated Qor-40 score for the two study groups to be compared assuming an overall standard deviation of 16 points similar to what was observed in a previous investigation.||27|3|.01
70971652|NCT00844753|141449574|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||Chi-squared|||||||0.47
70971653|NCT00844753|141449575|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||Chi-squared|||||||0.95
70971654|NCT00852995|141449582|SUPERIORITY_OR_OTHER|||||||0.00028|TWO_SIDED||||||t-test, 2 sided|||||||0.00028
70971655|NCT00852995|141449582|SUPERIORITY_OR_OTHER|||||||0.0899|TWO_SIDED||||||t-test, 2 sided|||||||0.0899
70971656|NCT00852995|141449582|SUPERIORITY_OR_OTHER|||||||0.1586|TWO_SIDED||||||t-test, 2 sided|||||||0.1586
70971657|NCT00852995|141449582|SUPERIORITY_OR_OTHER|||||||0.0295|TWO_SIDED||||||t-test, 2 sided|||||||0.0295
70971658|NCT00852995|141449584|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED|||||Treatment Week 01|ANCOVA|||||||.037
70971659|NCT00852995|141449584|SUPERIORITY_OR_OTHER|||||||0.064|TWO_SIDED|||||Treatment Week 02|ANCOVA|||||||.064
70971660|NCT00852995|141449584|SUPERIORITY_OR_OTHER|||||||0.161|TWO_SIDED|||||Treatment Week 03|ANCOVA|||||||.161
70971661|NCT00852995|141449584|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED|||||Treatment Week 04|ANCOVA|||||||.39
70971662|NCT00852995|141449584|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED|||||Treatment Week 05|ANCOVA|||||||.079
70971663|NCT00852995|141449584|SUPERIORITY_OR_OTHER|||||||0.069|TWO_SIDED|||||Treatment Week 06|ANCOVA|||||||.069
70971664|NCT00852995|141449584|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||Treatment Week 07|ANCOVA|||||||.026
70971665|NCT00852995|141449584|SUPERIORITY_OR_OTHER|||||||0.133|TWO_SIDED|||||Treatment Week 08|ANCOVA|||||||.133
70971666|NCT00852995|141449584|SUPERIORITY_OR_OTHER|||||||0.089|TWO_SIDED|||||Treatment Week 09|ANCOVA|||||||.089
70971667|NCT00852995|141449584|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED|||||Treatment Week 10|ANCOVA|||||||.057
70971668|NCT00852995|141449584|SUPERIORITY_OR_OTHER|||||||0.127|TWO_SIDED|||||Treatment Week 11|ANCOVA|||||||.127
70971669|NCT00852995|141449584|SUPERIORITY_OR_OTHER|||||||0.395|TWO_SIDED|||||Treatment Week 12|ANCOVA|||||||0.395
70971670|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.0133|TWO_SIDED|||||Visit 02|Cochran-Mantel-Haenszel|||||||0.0133
70971671|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.3839|TWO_SIDED|||||Visit 02|Cochran-Mantel-Haenszel|||||||0.3839
70971672|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.5721|TWO_SIDED|||||Visit 02|Cochran-Mantel-Haenszel|||||||0.5721
70971673|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.232|TWO_SIDED|||||Visit 02|Cochran-Mantel-Haenszel|||||||0.232
70971674|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.0787|TWO_SIDED|||||Visit 03|Cochran-Mantel-Haenszel|||||||0.0787
70971675|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.7919|TWO_SIDED|||||Visit 03|Cochran-Mantel-Haenszel|||||||0.7919
70971676|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.6881|TWO_SIDED|||||Visit 03|Cochran-Mantel-Haenszel|||||||0.6881
70971677|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.9832|TWO_SIDED|||||Visit 03|Cochran-Mantel-Haenszel|||||||0.9832
70971678|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.0466|TWO_SIDED|||||Visit 04|Cochran-Mantel-Haenszel|||||||0.0466
70971679|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.8435|TWO_SIDED|||||Visit 04|Cochran-Mantel-Haenszel|||||||0.8435
70971680|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.8743|TWO_SIDED|||||Visit 04|Cochran-Mantel-Haenszel|||||||0.8743
71093433|NCT02516241|141694040|SUPERIORITY||Odds Ratio (OR)|1.2||||0.6539|TWO_SIDED|95.0|0.5|3.3||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patients with improvement in fatigue||3.3|0.5|0.6539
71093434|NCT02516241|141694040|SUPERIORITY||Odds Ratio (OR)|2.2||||0.0092|TWO_SIDED|95.0|1.2|4.0||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood|Patient with deterioration in pain||4.0|1.2|0.0092
71093435|NCT02516241|141694040|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0324|TWO_SIDED|95.0|1.1|3.5||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patient with deterioration in pain||3.5|1.1|0.0324
71093436|NCT04070703|141694046|SUPERIORITY|The co-primary outcome data were analyzed via a Group by Time mixed-effects model with repeated measures on the second factor (i.e., outcome measures assessed at baseline and 6 months. In the presence of a Group by Time interaction effect, pre-specified follow-up pair-wise comparisons were performed to determine between-group differences.|Mean Difference (Final Values)|2.8||||0.0125|TWO_SIDED|98.75|2.1|3.6|||Mixed Models Analysis|||||3.6|2.1|0.0125
71093437|NCT04070703|141694046|SUPERIORITY||Mean Difference (Final Values)|1.5||||0.0125|TWO_SIDED|98.75|0.07|2.2|||Mixed Models Analysis|||||2.2|.07|.0125
71093438|NCT04070703|141694047|SUPERIORITY||Mean Difference (Final Values)|9.9||||0.0125|TWO_SIDED|98.75|2.8|16.6|||Mixed Models Analysis|||||16.6|2.8|.0125
71093439|NCT04070703|141694047|SUPERIORITY||Mean Difference (Final Values)|22.0||||0.0125|TWO_SIDED|98.75|12.6|31.2|||Mixed Models Analysis|||||31.2|12.6|.0125
71093440|NCT04070703|141694048|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.05|TWO_SIDED|95.0|-0.5|-0.1|||Mixed Models Analysis|||||-.1|-.5|0.05
70918836|NCT02528188|141328697|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.55|-0.18|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.18|-0.55|<0.0001
70918837|NCT02528188|141328697|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.66|-0.3|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.30|-0.66|<0.0001
70918838|NCT02528188|141328697|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.09||0.0115|TWO_SIDED|95.0|-0.42|-0.05|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.05|-0.42|0.0115
70971681|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.2884|TWO_SIDED|||||Visit 04|Cochran-Mantel-Haenszel|||||||0.2884
70971682|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.0387|TWO_SIDED|||||Visit 05|Cochran-Mantel-Haenszel|||||||0.0387
71093441|NCT04070703|141694048|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.05|TWO_SIDED|95.0|-0.7|-0.3|||Mixed Models Analysis|||||-.3|-.7|.05
71093442|NCT04070703|141694049|SUPERIORITY||Mean Difference (Final Values)|-14.1||||0.05|TWO_SIDED|95.0|-20.0|-8.0|||Mixed Models Analysis|||||-8|-20|.05
71093443|NCT04070703|141694049|SUPERIORITY||Mean Difference (Final Values)|-22.0||||0.05|TWO_SIDED|95.0|-28.0|-16.0|||Mixed Models Analysis|||||-16|-28|.05
71093444|NCT04070703|141694050|SUPERIORITY||Mean Difference (Final Values)|0.1|||<|0.05|TWO_SIDED|95.0|-0.4|0.1|||Mixed Models Analysis|||||.1|-.4|<.05
71093445|NCT04070703|141694050|SUPERIORITY||Mean Difference (Final Values)|0.8|||<|0.05|TWO_SIDED|95.0|0.4|1.2|||Mixed Models Analysis|||||1.2|.4|<.05
71093446|NCT04070703|141694051|SUPERIORITY||Mean Difference (Final Values)|1.1|||<|0.05|TWO_SIDED|95.0|0.5|1.6|||Mixed Models Analysis|||||1.6|.5|<.05
71093447|NCT04070703|141694051|SUPERIORITY||Mean Difference (Final Values)|2.2|||<|0.05|TWO_SIDED|95.0|1.6|2.7|||Mixed Models Analysis|||||2.7|1.6|<.05
71093448|NCT04070703|141694052|SUPERIORITY||Mean Difference (Final Values)|0.9|||<|0.05|TWO_SIDED|95.0|-0.4|2.1|||Mixed Models Analysis|||||2.1|-.4|<.05
71093449|NCT04070703|141694052|SUPERIORITY||Mean Difference (Final Values)|4.4|||<|0.05|TWO_SIDED|95.0|3.1|5.0|||Mixed Models Analysis|||||5|3.1|<.05
71093450|NCT04070703|141694053|SUPERIORITY||Mean Difference (Final Values)|0.3|||<|0.05|TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|||||.7|-.3|<.05
71093451|NCT04070703|141694053|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.05|TWO_SIDED|95.0|-2.4|-1.4|||Mixed Models Analysis|||||-1.4|-2.4|<.05
71093452|NCT04070703|141694054|SUPERIORITY||Mean Difference (Final Values)|-0.4|||<|0.05|TWO_SIDED|95.0|-1.4|0.4|||Mixed Models Analysis|||||.4|-1.4|<.05
71093453|NCT04070703|141694054|SUPERIORITY||Mean Difference (Final Values)|1.7|||<|0.05|TWO_SIDED|95.0|0.8|2.3|||Mixed Models Analysis|||||2.3|.8|<.05
71093454|NCT04070703|141694055|SUPERIORITY||Mean Difference (Final Values)|0.5|||<|0.05|TWO_SIDED|95.0|-0.1|1.1|||Mixed Models Analysis|||||1.1|-.1|<.05
71093455|NCT04070703|141694055|SUPERIORITY||Mean Difference (Final Values)|2.2|||<|0.05|TWO_SIDED|95.0|1.6|2.8|||Mixed Models Analysis|||||2.8|1.6|<.05
71093456|NCT04070703|141694056|SUPERIORITY||Mean Difference (Final Values)|0.1|||<|0.05|TWO_SIDED|95.0|-0.7|0.8|||Mixed Models Analysis|||||.8|-.7|<.05
71093457|NCT04070703|141694056|SUPERIORITY||Mean Difference (Final Values)|-2.2|||<|0.05|TWO_SIDED|95.0|-3.1|-1.3|||Mixed Models Analysis|||||-1.3|-3.1|<.05
71093458|NCT04070703|141694057|SUPERIORITY||Mean Difference (Final Values)|0.5|||<|0.05|TWO_SIDED|95.0|-0.3|1.2|||Mixed Models Analysis|||||1.2|-.3|<.05
71093459|NCT04070703|141694057|SUPERIORITY||Mean Difference (Final Values)|-1.0|||<|0.05|TWO_SIDED|95.0|-1.8|-0.2|||Mixed Models Analysis|||||-.2|-1.8|<.05
71153988|NCT01274338|141800089|SUPERIORITY|||||||0.289||||||If low dose Ipi (LIP) vs. HDI is significant for OS at the 2.2% level, then we will compare high dose Ipi (HIP) vs. HDI at the 2.2% level.|Log Rank|Stratified logrank test||This study has a two-step hierarchical approach. In the first step, the low-dose Ipi (LIP) will be compared with HDI. If the low-dose Ipi is significantly better than HDI, then the high-dose Ipi will be compared with HDI as a second step. When comparing the two investigational treatment groups, the primary comparison will be an intent to treat analysis of recurrence free survival (RFS; First Co-primary Endpoint) and overall survival (OS; Second Co-primary Endpoint).||||0.289
70918839|NCT02528188|141328697|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.63|-0.26|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.26|-0.63|<0.0001
70918840|NCT02528188|141328697|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.1||0.0002|TWO_SIDED|95.0|-0.56|-0.17|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.17|-0.56|0.0002
70918841|NCT02528188|141328697|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.67|-0.28|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.28|-0.67|<0.0001
70918842|NCT02528188|141328697|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.1||0.0002|TWO_SIDED|95.0|-0.57|-0.18|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.18|-0.57|0.0002
70918843|NCT02528188|141328697|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.64|-0.25|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.25|-0.64|<0.0001
70918844|NCT02528188|141328697|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.1||0.0238|TWO_SIDED|95.0|-0.44|-0.03|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.03|-0.44|0.0238
71093460|NCT04070703|141694058|SUPERIORITY||Mean Difference (Final Values)|1.4|||<|0.05|TWO_SIDED|95.0|-0.4|2.0|||Mixed Models Analysis|||||2|-.4|<.05
71093461|NCT04070703|141694058|SUPERIORITY||Mean Difference (Final Values)|5.7|||<|0.05|TWO_SIDED|95.0|3.1|7.9|||Mixed Models Analysis|||||7.9|3.1|<.05
71093462|NCT04070703|141694059|SUPERIORITY||Mean Difference (Final Values)|0.0|||<|0.05|TWO_SIDED|95.0|-0.04|0.03|||Mixed Models Analysis|||||.03|-.04|<.05
71093463|NCT04070703|141694059|SUPERIORITY||Mean Difference (Final Values)|0.07|||<|0.05|TWO_SIDED|95.0|0.03|0.11|||Mixed Models Analysis|||||.11|.03|<.05
71093464|NCT04070703|141694060|SUPERIORITY||Mean Difference (Final Values)|4.0|||<|0.05|TWO_SIDED|95.0|-2.0|6.0|||Mixed Models Analysis|||||6|-2|<.05
71093465|NCT04070703|141694060|SUPERIORITY||Mean Difference (Final Values)|125.5|||<|0.05|TWO_SIDED|95.0|84.0|166.0|||Mixed Models Analysis|||||166|84|<.05
71093466|NCT04070703|141694061|SUPERIORITY||Mean Difference (Final Values)|-0.2|||<|0.05|TWO_SIDED|95.0|-0.3|-0.1|||Mixed Models Analysis|||||-.1|-.3|<.05
71093467|NCT04070703|141694061|SUPERIORITY||Mean Difference (Final Values)|-0.5|||<|0.05|TWO_SIDED|95.0|-0.7|-0.4|||Mixed Models Analysis|||||-.4|-.7|<.05
71093468|NCT01081951|141694112|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51||||0.0012|TWO_SIDED|95.0|0.34|0.77||The use of a one-sided 10% significance level test will be used to assess the statistical significance of the analyses of PFS.|Log Rank|Stratified by number of prior platinum treatment lines (1 or \>1) and time to progression following previous platinum therapy (\>6 to ≤12 vs \>12 months)|A hazard ratio of \< 1 favours olaparib.|The null hypothesis for all efficacy analyses in this study is that there is no difference in treatment effects between olaparib in combination with carboplatin/paclitaxel compared with carboplatin/paclitaxel alone.||0.77|0.34|0.0012
71093469|NCT01081951|141694113|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17||||0.4379|TWO_SIDED|95.0|0.79|1.73||Two sided|Log Rank|Stratified by number of prior platinum treatment lines (1 or \>1) and time to progression following previous platinum therapy (\>6 to ≤12 vs \>12 months)|A hazard ratio \< 1 favours favours olaparib.|The null hypothesis for all efficacy analyses in this study is that there is no difference in treatment effects between olaparib in combination with carboplatin/paclitaxel compared with carboplatin/paclitaxel alone.||1.73|0.79|0.4379
71153989|NCT05472038|141800131|SUPERIORITY|Superiority based on GMR was declared if the lower limit of the 2-sided 95% CI for the GMR was greater than 1.|Model-Based GMR|2.91|||||TWO_SIDED|95.0|2.45|3.44||||||||3.44|2.45|
71153990|NCT05472038|141800132|NON_INFERIORITY|Noninferiority based on seroresponse was declared if the lower limit of the 2-sided 95% CI for the difference in percentages of participants with seroresponse is \>-5%.|Adjusted Difference in Percentages|26.77|||||TWO_SIDED|95.0|19.59|33.95|||||Adjusted difference and 2-Sided CI based on the Miettinen and Nurminen method stratified by baseline NT category (\< median,\>= median) for difference in proportions. The median of baseline NT was calculated based on pooled data in 2 comparator groups.|||33.95|19.59|
70918845|NCT02528188|141328697|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.11||0.0011|TWO_SIDED|95.0|-0.55|-0.14|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.14|-0.55|0.0011
70918846|NCT02528188|141328697|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.11||0.0064|TWO_SIDED|95.0|-0.51|-0.08|||ANCOVA|||Week 20: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.08|-0.51|0.0064
70918847|NCT02528188|141328697|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.11||0.0025|TWO_SIDED|95.0|-0.54|-0.12|||ANCOVA|||Week 20: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.12|-0.54|0.0025
70971683|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.8461|TWO_SIDED|||||Visit 05|Cochran-Mantel-Haenszel|||||||0.8461
70918848|NCT02528188|141328697|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.12||0.0589|TWO_SIDED|95.0|-0.48|0.01|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.01|-0.48|0.0589
70918849|NCT02528188|141328697|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.12||0.018|TWO_SIDED|95.0|-0.53|-0.05|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.05|-0.53|0.0180
70918850|NCT02528188|141328697|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.13||0.0944|TWO_SIDED|95.0|-0.47|0.04|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.04|-0.47|0.0944
70971684|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.9574|TWO_SIDED|||||Visit 05|Cochran-Mantel-Haenszel|||||||0.9574
70971685|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.2994|TWO_SIDED|||||Visit 05|Cochran-Mantel-Haenszel|||||||0.2994
70971686|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.1024|TWO_SIDED|||||Visit 06|Cochran-Mantel-Haenszel|||||||0.1024
70971687|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.8759|TWO_SIDED|||||Visit 06|Cochran-Mantel-Haenszel|||||||0.8759
70971688|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.9008|TWO_SIDED|||||Visit 06|Cochran-Mantel-Haenszel|||||||0.9008
70971689|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.4618|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.4618
70971690|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.2439|TWO_SIDED|||||Visit 07|Cochran-Mantel-Haenszel|||||||0.2439
70971691|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.749|TWO_SIDED|||||Visit 07|Cochran-Mantel-Haenszel|||||||0.749
70971692|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.3749|TWO_SIDED|||||Visit 07|Cochran-Mantel-Haenszel|||||||0.3749
70971693|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED|||||Visit 07|Cochran-Mantel-Haenszel|||||||0.015
70971694|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.0078|TWO_SIDED|||||Visit 08|Cochran-Mantel-Haenszel|||||||0.0078
70971695|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||Visit 08|Cochran-Mantel-Haenszel|||||||0.07
70971696|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.208|TWO_SIDED|||||Visit 08|Cochran-Mantel-Haenszel|||||||0.208
70971697|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.0413|TWO_SIDED|||||Visit 08|Cochran-Mantel-Haenszel|||||||0.0413
70971698|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.0054|TWO_SIDED|||||Visit 09|Cochran-Mantel-Haenszel|||||||0.0054
70971699|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.2031|TWO_SIDED|||||Visit 09|Cochran-Mantel-Haenszel|||||||0.2031
70971700|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.0894|TWO_SIDED|||||Visit 09|Cochran-Mantel-Haenszel|||||||0.0894
70971701|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.0288|TWO_SIDED|||||Visit 09|Cochran-Mantel-Haenszel|||||||0.0288
70971702|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.6964|TWO_SIDED|||||Visit 10|Cochran-Mantel-Haenszel|||||||0.6964
70971703|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|||||Visit 10|Cochran-Mantel-Haenszel|||||||0.59
70971704|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.7146|TWO_SIDED|||||Visit 10|Cochran-Mantel-Haenszel|||||||0.7146
70971705|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.5008|TWO_SIDED|||||Visit 10|Cochran-Mantel-Haenszel|||||||0.5008
70971706|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.1235|TWO_SIDED|||||Visit 11|Cochran-Mantel-Haenszel|||||||0.1235
70971707|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.5488|TWO_SIDED|||||Visit 11|Cochran-Mantel-Haenszel|||||||0.5488
70971708|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.4343|TWO_SIDED|||||Visit 11|Cochran-Mantel-Haenszel|||||||0.4343
70971709|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.1114|TWO_SIDED|||||Visit 11|Cochran-Mantel-Haenszel|||||||0.1114
71093470|NCT00975923|141694159|SUPERIORITY_OR_OTHER||infection rates per device days|2.0|STANDARD_ERROR_OF_MEAN|0.05|<|0.05|TWO_SIDED|95.0|1.0|3.0||p-value and confidence intervals|Regression, Linear|||Infection rates were analyzed using hierarchical negative binomial regression models to model infection rate changes over time and account for clustering of ICUs within hospitals and adjusting for baseline covariates. Power was calculated a priori with a 1-tailed alpha of 0.05 and group size of 30; a 50% decrease in infection rates in the Collaborative group and 15% for the Tool Kit group, yielding power ranging from 82% to 91% for testing group differences.||3.0|1.0|<.05
71093471|NCT00975923|141694160|SUPERIORITY_OR_OTHER||percentages|10.0|||<|5|TWO_SIDED|95.0|||||Chi-squared||Power calculation used alpha = .05 and group size = 30.The estimated effect was a 50% decrease in infection rates for the Collaborative Group and from 10% to 15% decrease in the Tool Kit group.Power ranged from 82%-91% for testing group differences.|It was hypothesized that the Collaborative group would engage in more processes and tools than the Tool Kit group. Power was based on infection rates.||||<05
71093472|NCT02612155|141694173|OTHER|||||||0.06|||||||Fisher Exact|||||||0.06
71093473|NCT04435626|141694180|SUPERIORITY||Rate ratio|0.84||||0.0072|TWO_SIDED|95.0|0.74|0.95||Two-sided p-value; p-value threshold =0.04967;|stratified Andersen-Gill model|stratified Andersen-Gill model with robust sandwich estimate for the covariance matrix of recurrent events|stratified Andersen-Gill model with robust sandwich estimate for the covariance matrix of recurrent events|Rate Ratio (Finerenone/Placebo)||0.95|0.74|0.0072
71093474|NCT04435626|141694182|SUPERIORITY||Rate ratio|0.82||||0.0062|TWO_SIDED|95.0|0.71|0.94||Two-sided p-value; p-value threshold=0.04967;|Stratified Andersen-Gill model|stratified Andersen-Gill model with robust sandwich estimate for the covariance matrix of recurrent events|stratified Andersen-Gill model with robust sandwich estimate for the covariance matrix of recurrent events|Rate Ratio (Finerenone/Placebo)||0.94|0.71|0.0062
71093475|NCT04435626|141694184|OTHER|mixed-effects model for repeated measures (MMRM)|Difference in LS Mean|1.56|||<|0.0001|TWO_SIDED|95.0|0.79|2.34||Two-sided p-value;|Mixed Models Analysis|The analysis was performed using mixed-effects model for repeated measures (MMRM)||Difference in LS Mean||2.34|0.79|<.0001
71093476|NCT04435626|141694185|OTHER|Logistic regression analysis|Odds Ratio (OR)|1.01||||0.9295|TWO_SIDED|95.0|0.88|1.15||Two-sided p-value|Regression, Logistic|||Odds ratio (finerenone /placebo)||1.15|0.88|0.9295
71093477|NCT04435626|141694186|OTHER|Stratified log-rank test|Cause-specific Hazard Ratio|1.33||||0.1071|TWO_SIDED|95.0|0.94|1.89||two-sided p-value|Stratified log-rank test||stratified Cox proportional hazards model|Cause-specific Hazard Ratio||1.89|0.94|0.1071
70971710|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.2119|TWO_SIDED|||||Visit 12|Cochran-Mantel-Haenszel|||||||0.2119
71093478|NCT04435626|141694187|OTHER|Stratified log-rank test|cause-specific hazard ratio|0.93||||0.2794|TWO_SIDED|95.0|0.83|1.06||two-sided p-value|stratified log-rank||stratified Cox proportional hazards model|Hazard Ratio||1.06|0.83|0.2794
71093479|NCT02595892|141694188|OTHER||Hazard Ratio (HR)|0.57||||0.044|TWO_SIDED|90.0|0.33|0.98|||Log Rank|||||.98|.33|0.044
71093480|NCT02595892|141694191|OTHER|||||||0.44|||||||Fisher Exact|Two-Sided Fisher's exact test.||||||0.44
70971711|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.0194|TWO_SIDED|||||Visit 12|Cochran-Mantel-Haenszel|||||||0.0194
71093481|NCT05252702|141694215|SUPERIORITY|"The primary safety endpoint hypothesis at 3 months was formally expressed as:~H0: CFR ≤ 78% vs. H1: CFR \> 78%~where 78% was the performance goal (PG)."|binomial proportion|90.3|||<|0.0001|ONE_SIDED|97.5|87.0|||The CFR was estimated as a binomial proportion and a one-sided 97.5% lower confidence bound of the CFR was calculated using the normal approximation. The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the PG|one-sided Z-test|The p-value from a one-sided Z-test for the binomial proportion was calculated and compared to the 0.025 significance level.|||||87|<0.0001
71093482|NCT05252702|141694216|SUPERIORITY|"The primary safety endpoint hypothesis at 12 months was formally expressed as:~H0: CFR ≤ 76.5% vs. H1: CFR \> 76.5%~where 76.5% is the performance goal. The CFR was estimated using a Kaplan-Meier survival analysis and the 97.5% lower confidence bound of CFR was calculated using the Greenwood variance estimates."|Kaplan-Meier|88.6|||<|0.0001|ONE_SIDED|97.5|84.5|||The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the Performance Goal (PG) of 76.5%.|one-sided Z-test|The p-value for the one-sided Z-test was calculated and compared to the 2.5% significance level.|||||84.5|<0.0001
71093483|NCT05252702|141694217|SUPERIORITY||binomial proportion|90.8|||<|0.0001|ONE_SIDED|97.5|87.5|||The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the PG of 82.5%.|one-sided Z-test|The p-value for the one-sided Z-test was to be calculated and compared to the 2.5% significance level.||"The primary effectiveness endpoint #1 hypothesis at 3 month was formally expressed as:~H0: Rate ≤ 82.5% vs. H1: Rate \> 82.5%~where 82.5% was the performance goal (PG)."|||87.5|<0.0001
71093484|NCT05252702|141694218|SUPERIORITY||binomial proportion|92.8|||<|0.0001|ONE_SIDED|97.5|89.7|||The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the PG of 80%.|one-sided Z-test|The p-value for the one-sided Z-test was to be calculated and compared to the 2.5% significance level.|The Rate at 12 months was estimated as a binomial proportion and the one-sided 97.5% LCB of the Rate was calculated using the normal approximation.|"The primary effectiveness endpoint #1 hypothesis at 12 months was formally expressed as:~H0: Rate ≤ 80% vs. H1: Rate \> 80%~where 80% was the performance goal (PG)."|||89.7|<0.0001
70971712|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.506|TWO_SIDED|||||Visit 12|Cochran-Mantel-Haenszel|||||||0.506
70971713|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.2317|TWO_SIDED|||||Visit 12|Cochran-Mantel-Haenszel|||||||0.2317
70971714|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.1144|TWO_SIDED|||||Visit 13|Cochran-Mantel-Haenszel|||||||0.1144
70971715|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.6786|TWO_SIDED|||||Visit 13|Cochran-Mantel-Haenszel|||||||0.6786
70971716|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.7735|TWO_SIDED|||||Visit 13|Cochran-Mantel-Haenszel|||||||0.7735
70971717|NCT00852995|141449585|SUPERIORITY_OR_OTHER|||||||0.758|TWO_SIDED|||||Visit 13|Cochran-Mantel-Haenszel|||||||0.758
70971718|NCT00852995|141449586|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|||||Week 04|Cochran-Mantel-Haenszel|||||||0.017
71093485|NCT05252702|141694219|SUPERIORITY||binomial proportion|98.2|||<|0.0001|ONE_SIDED|97.5|96.6|||The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the PG of 83%.|one-sided Z-test|The p-value for the one-sided Z-test was to be calculated and compared to the 2.5% significance level.||"The primary effectiveness endpoint #2 hypothesis was formally expressed as:~H0: RateAV ≤ 83% vs. H1: RateAV \> 83%~where 83% is the performance goal."|||96.6|<0.0001
71093486|NCT05252702|141694220|SUPERIORITY||binomial proportion|91.3||||0.0003|ONE_SIDED|97.5|88.1|||The null hypothesis was to be rejected at the 2.5% significance level if the lower confidence bound exceeded the Performance Goal (PG) of 84%.|one-sided Z-test|The p-value from a one-sided Z-test for the binomial proportion was to be calculated and compared to the 0.025 significance level.||"The secondary safety endpoint hypothesis at 3 months was formally expressed as:~H0: CFRA ≤ 84% vs. H1: CFRA \> 84%~where 84% was the performance goal."|||88.1|0.0003
71153991|NCT05472038|141800133|NON_INFERIORITY|Noninferiority based on the GMR was declared if the lower limit of the 2-sided 95% CI for the GMR is greater than 0.67 (1.5-fold criterion) and the point estimate of the GMR was \>=0.8.|Model-Based GMR|0.98|||||TWO_SIDED|95.0|0.83|1.16|||||GMR and 2-sided 95% CIs were calculated by exponentiating the difference of LS means and corresponding CIs based on the regression model included terms for baseline neutralizing titer and comparison group.|||1.16|0.83|
70918851|NCT02528188|141328697|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1198|TWO_SIDED|95.0|-0.45|0.05|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.05|-0.45|0.1198
70918852|NCT02528188|141328697|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.13||0.1837|TWO_SIDED|95.0|-0.43|0.08|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.08|-0.43|0.1837
70918853|NCT02528188|141328697|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.13||0.317|TWO_SIDED|95.0|-0.39|0.13|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.13|-0.39|0.3170
70918854|NCT02528188|141328697|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.13||0.1873|TWO_SIDED|95.0|-0.43|0.08|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.08|-0.43|0.1873
70918855|NCT02528188|141328697|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.13||0.5719|TWO_SIDED|95.0|-0.33|0.18|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.18|-0.33|0.5719
70918856|NCT02528188|141328697|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.13||0.3571|TWO_SIDED|95.0|-0.39|0.14|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.14|-0.39|0.3571
70918857|NCT02528188|141328697|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.14||0.9072|TWO_SIDED|95.0|-0.25|0.28|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.28|-0.25|0.9072
70918858|NCT02528188|141328699|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.09||0.0004|TWO_SIDED|95.0|-0.49|-0.14|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.14|-0.49|0.0004
70918859|NCT02528188|141328699|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.09||0.0134|TWO_SIDED|95.0|-0.4|-0.05|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.40|0.0134
70971719|NCT00852995|141449586|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED|||||Week 04|Cochran-Mantel-Haenszel|||||||.041
70971720|NCT00852995|141449586|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|||||Week 05|Cochran-Mantel-Haenszel|||||||.017
70971721|NCT00852995|141449586|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|||||Week 06|Cochran-Mantel-Haenszel|||||||.011
71153992|NCT05472038|141800134|NON_INFERIORITY|Noninferiority based on seroresponse was declared if the lower limit of the 2-sided 95% CI for the difference in percentages of participants with seroresponse is \>-10%.|Adjusted Difference in Percentages|-3.03|||||TWO_SIDED|95.0|-9.68|3.63|||||2-Sided CI based on Miettinen and Nurminen method stratified by baseline NT category(\< median,\>= median)for difference in percentage(seroresponse rate).Median of baseline neutralizing titers was calculated based on pooled data in 2 comparator groups.|||3.63|-9.68|
70971722|NCT00852995|141449586|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED|||||Week 07|Cochran-Mantel-Haenszel|||||||.014
70971723|NCT00852995|141449586|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED|||||Week 08|Cochran-Mantel-Haenszel|||||||.029
70918860|NCT02528188|141328699|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.56|-0.19|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.19|-0.56|<0.0001
70918861|NCT02528188|141328699|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.67|-0.29|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.29|-0.67|<0.0001
70918862|NCT02528188|141328699|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.1||0.0031|TWO_SIDED|95.0|-0.49|-0.1|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.10|-0.49|0.0031
70918863|NCT02528188|141328699|SUPERIORITY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.82|-0.43|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.43|-0.82|<0.0001
70918864|NCT02528188|141328699|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.0425|TWO_SIDED|95.0|-0.43|-0.01|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.01|-0.43|0.0425
70918865|NCT02528188|141328699|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.65|-0.23|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.23|-0.65|<0.0001
70918866|NCT02528188|141328699|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.13||0.298|TWO_SIDED|95.0|-0.4|0.12|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.12|-0.40|0.2980
70918867|NCT02528188|141328699|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.13||0.0179|TWO_SIDED|95.0|-0.58|-0.05|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.58|0.0179
70918868|NCT02528188|141328699|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.13||0.2328|TWO_SIDED|95.0|-0.42|0.1|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.10|-0.42|0.2328
70918869|NCT02528188|141328699|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.14||0.1019|TWO_SIDED|95.0|-0.49|0.04|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.04|-0.49|0.1019
70918870|NCT02528188|141328699|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.14||0.4002|TWO_SIDED|95.0|-0.38|0.15|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.15|-0.38|0.4002
70918871|NCT02528188|141328699|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.2149|TWO_SIDED|95.0|-0.45|0.1|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.10|-0.45|0.2149
70971724|NCT00852995|141449586|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED|||||Week 09|Cochran-Mantel-Haenszel|||||||.021
70971725|NCT00852995|141449586|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED|||||Week 10|Cochran-Mantel-Haenszel|||||||.041
70971726|NCT00852995|141449586|SUPERIORITY_OR_OTHER|||||||0.044|TWO_SIDED|||||Week 10|Cochran-Mantel-Haenszel|||||||.044
70971727|NCT00852995|141449586|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||Week 11|Cochran-Mantel-Haenszel|||||||.013
70971728|NCT00852995|141449586|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED|||||Week 11|Cochran-Mantel-Haenszel|||||||.024
70971729|NCT00852995|141449586|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED|||||Week 12|Cochran-Mantel-Haenszel|||||||.027
70971730|NCT00852995|141449588|SUPERIORITY_OR_OTHER|||||||0.0211|TWO_SIDED|||||P-value for Kaplan-Meier Days to Closure|ANCOVA|||||||0.0211
71093487|NCT05252702|141694221|SUPERIORITY||Kaplan-Meier|91.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|ONE_SIDED|97.5|87.1|||The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the Performance Goal (PG) of 82%.|one-sided Z-test|The p-value for the one-sided Z-test was to be calculated and compared to the 2.5% significance level.|The 97.5% lower confidence bound (LCB) of CFRA was calculated using the Greenwood variance estimates.|"The secondary safety endpoint hypothesis at 12 months was formally expressed as:~H0: CFRA ≤ 82% vs. H1: CFRA \> 82%~where 82% is the performance goal."|||87.1|<0.0001
71093488|NCT05252702|141694222|OTHER||mixed effects model for repeated measure|0.91|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|0.78|1.04|||t-test, 1 sided|Two one-sided t-tests (TOST), with an alpha level of 0.025, and n-1 degrees of freedom.||"An analysis of these data provided an estimate of the 95% confidence interval for the mean slope across analyzable subjects, which had a pre-specified success criterion requiring that this confidence interval must fall between slopes of 65% and 135%. The following hypothesis was evaluated:~H0: Mean Slope \< 0.65 or Mean Slope \> 1.35~H1: 0.65 ≤ Mean Slope ≤ 1.35"||1.04|0.78|<0.001
71093489|NCT00373672|141694332|SUPERIORITY||||||<|0.016|||||||t-test, 2 sided|||Treatment effects were analyzed using a repeated measures analysis of variance model with time (baseline, 6 weeks) as the within-subjects factor and treatment group (armodafinil, placebo) as the between-subjects factor.||||<0.016
71093490|NCT04871074|141694333|SUPERIORITY|||||||0.74|||||||DeLong's Test|||||||.74
71093491|NCT04871074|141694334|SUPERIORITY|||||||0.66|||||||DeLong's Test|||||||.66
71093492|NCT04871074|141694335|SUPERIORITY|||||||0.135|||||||Mixed Models Analysis|Linear mixed effects model, fixed effects coefficient test with a Wald test||||||.135
71093493|NCT04871074|141694339|SUPERIORITY|||||||0.39|||||||Mixed Models Analysis|Fixed effects estimate, Wald test||||||.39
71093494|NCT00098475|141694352|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The low-dose response would be considered unacceptable if the difference in response rates was 15% or greater (the upper confidence limit exceeds the 15% acceptable difference) regardless of a decrease in toxicity rate.|Difference in response rate between arms|0.107|||||TWO_SIDED|80.0|0.052|0.162||||||The study was designed to determine if a reduced dose of dexamethasone in combination with CC-5013 reduced toxicity rate without reducing response rate. The standard-dose response was expected to be 70%. The low dose would be deemed unacceptable if the difference in response rate between arms was \>=15%. The null hypothesis was that response rates were equal and the alternative was that the low-dose response was no worse than 55%. The design had a 1-sided 0.10 type I error rate and 95% power.||0.162|0.052|
71093495|NCT02512419|141694359|SUPERIORITY||regression parameter (median diff)|37.52|STANDARD_ERROR_OF_MEAN|18.01||0.04|TWO_SIDED||||||quantile regression|Models regressed outcome at 6 months on treatment assigned, baseline value of the outcome and actigraph wear time. Effect sizes reported are adjusted|Effects are unstandardized regression coefficients. They represent difference in median outcome between conditions at 6m controlling for baseline and covariates.|To examine potential intervention effects on the primary outcome (MVPA at 6 months), we used a series of quantile regression models which model median outcome at follow-up as a function of baseline value of the outcome (MVPA), treatment condition and covariates. Note that the adjusted difference in median MVPA between conditions at follow-up will not equal the difference in median minutes as seen in the unadjusted tables as these estimates are adjusted||||.04
71093496|NCT02512419|141694360|SUPERIORITY||Median Difference (Final Values)|42.36|STANDARD_ERROR_OF_MEAN|38.83||0.1|TWO_SIDED||||||quantile regression|||Quantile regression was used.||||0.10
71093497|NCT03976375|141694412|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.4342|TWO_SIDED|95.0|0.78|1.23||Stratified by Baseline ECOG performance status (0 versus 1), anti-PD-1/PD-L1 mAb (immediate prior therapy versus not the immediate prior therapy), and Baseline PD-L1 Status (\<50% versus \>=50)|Log Rank||Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status|||1.23|0.78|0.4342
71153993|NCT05472038|141800139|NON_INFERIORITY|Noninferiority based on the GMR was declared if the lower limit of the 2-sided 95% CI for the GMR is greater than 0.67 (1.5-fold criterion) and the point estimate of the GMR was \>=0.8.|Model-Based GMR|1.38|||||TWO_SIDED|95.0|1.22|1.56|||||GMR and 2-sided 95% CIs were calculated by exponentiating the difference of LS means and corresponding CIs based on the regression model included terms for baseline neutralizing titer and comparison group.|||1.56|1.22|
70971731|NCT00852995|141449588|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.83||||0.0212|TWO_SIDED|95.0|1.09|3.04|||Regression, Cox|||||3.04|1.09|.0212
71093498|NCT03976375|141694413|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.1563|TWO_SIDED|95.0|0.7|1.12||Stratified by Baseline ECOG performance status (0 versus 1), anti-PD-1/PD-L1 mAb (immediate prior therapy versus not the immediate prior therapy), and Baseline PD-L1 Status (\<50% versus \>=50)|Log Rank||Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|||1.12|0.70|0.1563
71093499|NCT03976375|141694414|SUPERIORITY||Difference in Percentage vs Docetaxel|8.4||||0.01818|TWO_SIDED|95.0|0.5|16.3||One-sided p-value for testing. H0: difference in % =0 versus H1: difference in % \> 0.|Miettinen and Nurminen method||Based on Miettinen \& Nurminen method stratified by Baseline ECOG performance status (0 versus 1), anti-PD-1/PD-L1 mAb (immediate prior therapy versus not the immediate prior therapy), and Baseline PD-L1 Status (\<50% versus \>=50%)|||16.3|0.5|0.01818
71093500|NCT03976375|141694415|SUPERIORITY||Difference in Percentage vs Lenvatinib|10.2||||0.06009|TWO_SIDED|95.0|-3.1|19.9||One-sided p-value for testing. H0: difference in % =0 versus H1: difference in % \> 0.|Miettinen & Nurminen method|||||19.9|-3.1|0.06009
71093501|NCT03976375|141694419|OTHER||Difference in least squares means|-1.36||||0.4998|TWO_SIDED|95.0|-5.32|2.6|||t-test, 2 sided||Based on cLDA model with covariates for treatment by time interaction, stratification factors of baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and baseline PD-L1 Status|||2.60|-5.32|0.4998
71093502|NCT03976375|141694420|OTHER||Difference in Least Squares Mean|-3.86||||0.1531|TWO_SIDED|95.0|-9.16|1.44|||t-test, 2 sided||Based on cLDA model with covariates for treatment by time interaction, stratification factors of baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and baseline PD-L1 Status|||1.44|-9.16|0.1531
70971732|NCT00852995|141449588|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||ANCOVA|||||||0.59
70971733|NCT00852995|141449588|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.53|TWO_SIDED|95.0|0.69|2.05||This is the P-value for the Cox Hazard Ratio|Regression, Cox|||||2.05|.69|0.53
71093503|NCT03976375|141694421|OTHER||Difference in Least Squares Means|2.48||||0.3084|TWO_SIDED|95.0|-2.31|7.27|||t-test, 2 sided||Based on cLDA model with covariates for treatment by time interaction, stratification factors of baseline ECOG performance status, timing of anti-PD-1/PD-L1 mAb therapy, and baseline PD-L1 Status|||7.27|-2.31|0.3084
71093504|NCT03976375|141694422|OTHER||Difference in Least Squares Means|-8.04||||0.0058|TWO_SIDED|95.0|-13.73|-2.35|||t-test, 2 sided||Based on cLDA model with covariates for treatment by time interaction, stratification factors of baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and baseline PD-L1 Status|||-2.35|-13.73|0.0058
71093505|NCT03976375|141694423|OTHER||Difference in Least Squares Means|2.89||||0.1681|TWO_SIDED|95.0|-1.23|7.01|||t-test, 2 sided||Based on cLDA model with covariates for treatment by time interaction, stratification factors of baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and baseline PD-L1 Status|||7.01|-1.23|0.1681
71093506|NCT03976375|141694424|OTHER||Hazard Ratio (HR)|0.91||||0.6145|TWO_SIDED|95.0|0.63|1.31||stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|Log Rank||Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|||1.31|0.63|0.6145
71093507|NCT03976375|141694425|OTHER||Hazard Ratio (HR)|0.61||||0.0398|TWO_SIDED|95.0|0.38|0.98|||Log Rank|Stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|||0.98|0.38|0.0398
71093508|NCT03976375|141694426|OTHER||Hazard Ratio (HR)|1.05||||0.8724|TWO_SIDED|95.0|0.59|1.85|||Log Rank|Stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status|||1.85|0.59|0.8724
71093509|NCT03976375|141694427|OTHER||Hazard Ratio (HR)|0.75||||0.1944|TWO_SIDED|95.0|0.49|1.16||Stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|Log Rank||Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|||1.16|0.49|0.1944
71093510|NCT03976375|141694428|OTHER||Hazard Ratio (HR)|1.0||||0.9837|TWO_SIDED|95.0|0.71|1.41|||Log Rank|Stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|||1.41|0.71|0.9837
71093511|NCT03976375|141694429|OTHER||Hazard Ratio (HR)|0.84||||0.2903|TWO_SIDED|95.0|0.6|1.16|||Log Rank|Stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|||1.16|0.60|0.2903
71093512|NCT04635423|141694430|SUPERIORITY||Observed Efficacy (%)|89.3|||<|0.001|TWO_SIDED|95.0|55.4|98.2||one-sided p-value based on exact binomial method proposed by Chan and Bohidar|Exact Binomial Method Chan and Bohidar||The statistical criterion for success requires that the lower bound of the 2-sided 95% confidence interval (CI) for vaccine efficacy (VE) against the primary efficacy endpoint is greater than 0%.|||98.2|55.4|<0.001
70918872|NCT02528188|141328699|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.14||0.2442|TWO_SIDED|95.0|-0.43|0.11|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.11|-0.43|0.2442
70918873|NCT02528188|141328699|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.4609|TWO_SIDED|95.0|-0.37|0.17|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.17|-0.37|0.4609
71093513|NCT04635423|141694431|OTHER||Difference in Percentages|40.1|||||TWO_SIDED|95.0|34.5|45.5|||Miettinen & Nurminen method||Difference in percentages calculated as % V503 minus % Placebo.|||45.5|34.5|
71093514|NCT04635423|141694432|OTHER||Difference in Percentage|0.4|||||TWO_SIDED|95.0|-4.4|5.2|||Miettinen & Nurminen method||Difference in percentages calculated as % V503 minus % Placebo.|||5.2|-4.4|
71093515|NCT04635423|141694435|SUPERIORITY||Observed Efficacy (%)|63.5||||0.023|TWO_SIDED|95.0|2.7|86.0||one-sided p-value based on exact binomial method proposed by Chan and Bohidar|Exact Binomial Method Chan and Bohidar||The statistical criterion for success requires that the lower bound of the 2-sided 95% confidence interval (CI) for vaccine efficacy (VE) against the primary efficacy endpoint is greater than 0%.|||86.0|2.7|0.023
71093516|NCT05119569|141694483|SUPERIORITY||Rate Ratio|0.313||||0.0022|TWO_SIDED|95.0|0.149|0.658|||Negative Binomial Regression Model|||||0.658|0.149|0.0022
71093517|NCT05119569|141694484|SUPERIORITY||Rate Ratio|0.265||||0.0004|TWO_SIDED|95.0|0.128|0.55|||Negative Binomial Regression Model|||||0.550|0.128|0.0004
71093518|NCT05119569|141694485|SUPERIORITY||Odds Ratio (OR)|4.005||||0.0117|TWO_SIDED|95.0|1.317|13.078|||Logistic Regression Model|||||13.078|1.317|0.0117
71093519|NCT05119569|141694490|SUPERIORITY||Rate Ratio|0.78||||0.5889|TWO_SIDED|95.0|0.316|1.922|||Negative Binomial Regression Model|||||1.922|0.316|0.5889
71093520|NCT05119569|141694491|SUPERIORITY||Rate Ratio|0.076||||0.0011|TWO_SIDED|95.0|0.016|0.355|||Negative Binomial Regression Model|||||0.355|0.016|0.0011
71093521|NCT05119569|141694492|SUPERIORITY||Rate Ratio|0.104||||0.0038|TWO_SIDED|95.0|0.022|0.481|||Negative Binomial Regression Model|||||0.481|0.022|0.0038
70971734|NCT00852995|141449588|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||ANCOVA|Kaplan-Meier Days to Closure||||||0.26
71093522|NCT05119569|141694493|SUPERIORITY||Rate Ratio|0.512||||0.0958|TWO_SIDED|95.0|0.233|1.126|||Negative Binomial Regression Model|||||1.126|0.233|0.0958
70918874|NCT02528188|141328699|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8129|TWO_SIDED|95.0|-0.31|0.24|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.24|-0.31|0.8129
70918875|NCT02528188|141328699|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7883|TWO_SIDED|95.0|-0.32|0.24|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.24|-0.32|0.7883
71093523|NCT05119569|141694494|SUPERIORITY||Rate Ratio|0.105|||<|0.0001|TWO_SIDED|95.0|0.039|0.283|||Negative Binomial Regression Model|||||0.283|0.039|<0.0001
70918876|NCT02528188|141328701|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.08||0.0119|TWO_SIDED|95.0|-0.37|-0.05|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.37|0.0119
70918877|NCT02528188|141328701|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.08||0.3073|TWO_SIDED|95.0|-0.24|0.08|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.08|-0.24|0.3073
70918878|NCT02528188|141328701|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.09||0.0002|TWO_SIDED|95.0|-0.5|-0.15|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.15|-0.50|0.0002
70918879|NCT02528188|141328701|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.56|-0.22|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.22|-0.56|<0.0001
70918880|NCT02528188|141328701|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.09||0.0251|TWO_SIDED|95.0|-0.39|-0.03|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.03|-0.39|0.0251
70918881|NCT02528188|141328701|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.66|-0.3|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.30|-0.66|<0.0001
70918882|NCT02528188|141328701|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.0625|TWO_SIDED|95.0|-0.39|0.01|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.01|-0.39|0.0625
70918883|NCT02528188|141328701|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.54|-0.14|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.14|-0.54|0.0010
70918884|NCT02528188|141328701|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.4005|TWO_SIDED|95.0|-0.36|0.14|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.14|-0.36|0.4005
70918885|NCT02528188|141328701|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.13||0.053|TWO_SIDED|95.0|-0.5|0.0|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.00|-0.50|0.0530
71093524|NCT05119569|141694495|SUPERIORITY||Rate Ratio|0.053||||0.0001|TWO_SIDED|95.0|0.012|0.233|||Negative Binomial Regression Model|||||0.233|0.012|0.0001
71093525|NCT00434434|141694506|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13||95.0|||||Wilcoxon (Mann-Whitney)|exact Wilcoxon-Mann-Whitney||||||0.13
71093526|NCT00434434|141694506|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0133||95.0|||||Wilcoxon (Mann-Whitney)|exact Wilcoxon-Mann-Whitney||||||0.0133
71093527|NCT00434434|141694507|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09||95.0|||||Wilcoxon (Mann-Whitney)|exact Wilcoxon-Mann-Whitney||||||0.09
71093528|NCT00434434|141694507|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0028||95.0|||||Wilcoxon (Mann-Whitney)|exact Wilcoxon-Mann-Whitney||||||0.0028
70918886|NCT02528188|141328701|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.4074|TWO_SIDED|95.0|-0.37|0.15|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.15|-0.37|0.4074
70918887|NCT02528188|141328701|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.13||0.2629|TWO_SIDED|95.0|-0.41|0.11|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.11|-0.41|0.2629
70918888|NCT02528188|141328701|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.13||0.5582|TWO_SIDED|95.0|-0.34|0.18|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.18|-0.34|0.5582
70918889|NCT02528188|141328701|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.13||0.4907|TWO_SIDED|95.0|-0.35|0.17|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.17|-0.35|0.4907
70918890|NCT02528188|141328701|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.14||0.4043|TWO_SIDED|95.0|-0.38|0.15|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.15|-0.38|0.4043
70918891|NCT02528188|141328701|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7663|TWO_SIDED|95.0|-0.31|0.23|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.23|-0.31|0.7663
70918892|NCT02528188|141328701|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7415|TWO_SIDED|95.0|-0.31|0.22|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.22|-0.31|0.7415
70918893|NCT02528188|141328701|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.13||0.8688|TWO_SIDED|95.0|-0.24|0.29|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.29|-0.24|0.8688
70918894|NCT02528188|141328703|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.09||0.3622|TWO_SIDED|95.0|-0.25|0.09|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.09|-0.25|0.3622
70918895|NCT02528188|141328703|SUPERIORITY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.09||0.3894|TWO_SIDED|95.0|-0.09|0.24|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.24|-0.09|0.3894
70918896|NCT02528188|141328703|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.09||0.0137|TWO_SIDED|95.0|-0.42|-0.05|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.42|0.0137
71093529|NCT01922934|141694508|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
70918897|NCT02528188|141328703|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.09||0.0106|TWO_SIDED|95.0|-0.43|-0.06|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.06|-0.43|0.0106
70971735|NCT00852995|141449588|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.43||||0.19|TWO_SIDED|95.0|0.84|2.44||This is the P-value for the Cox Proportional Hazard Ratio|Regression, Cox|||||2.44|0.84|0.19
71153994|NCT04934722|141800203|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.24|2.34|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||2.34|0.24|
71153995|NCT04934722|141800204|OTHER||Hazard Ratio (HR)|1.35|||||TWO_SIDED|95.0|0.3|6.01|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||6.01|0.30|
71093530|NCT02290184|141694513|SUPERIORITY_OR_OTHER|A multi-level regression was employed to test differences between the 2 arm's change trajectories of their estimated simple slopes. Bootstrapped full information maximum likelihood models were estimated to obtain nonparametric, bias-corrected confidence interval (CI).|cross-level interaction|-2.0|||||TWO_SIDED|0.05|-3.0|-1.1|||||"Multilevel regression analysis was used. The primary test of between-group change effect is also called the cross-level interaction between time and group. Simple slopes were also tested to determine if the change was significant within each group."|Hypothesis: the intervention group will have a significantly greater reduction in weight (kg) compared to the active control from baseline to 3-months.||-1.1|-3.0|
71093531|NCT02290184|141694514|SUPERIORITY|Multi-level regression was used to test differences between the 2 arm's change trajectories of their estimated simple slopes. Bootstrapped full information maximum likelihood models were estimated to obtain nonparametric, bias-corrected CI.|cross-level interaction|-2.6|||||TWO_SIDED|0.05|-3.9|-1.4|||||"Multilevel regression was used. The primary test of between group change effect is also called the cross-level interaction between time and group. Simple slopes were also tested to determine if the change was significant within each group."|Hypothesis: Intervention group will have a significantly greater reduction in % weight change compared to the active control from baseline to 3-months||-1.4|-3.9|
71093532|NCT02290184|141694515|SUPERIORITY|A multi-level regression was used to test differences between the 2 arm's change trajectories of their estimated simple slopes. Bootstrapped full information maximum likelihood models were estimated to obtain nonparametric, bias-corrected CI.|cross-level interaction|-2.7|||||TWO_SIDED|95.0|-4.5|-0.91|||||"Multilevel regression was used. The primary test of between -group change effect is also called the cross-level interaction between time and group. Simple slopes were also tested to determine if the change was significant within each group."|Hypothesis: Intervention group will have a significantly greater reduction in waist-circumference (cm) compared to the Active Control from baseline to 3-months||-.91|-4.5|
71093533|NCT02354118|141694520|NON_INFERIORITY|10% non-inferiority margin||||||1|||||||Chi-squared|||||||1.0
71093534|NCT01069939|141694521|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.09|||<|0.001|TWO_SIDED|96.65|0.02|0.41||An interim analysis was done so that the significance level was adjusted using the Pocock-like alpha-spending function with Lan-DeMets approach. The adjusted significance level was the two-sided 3.35%.|Log Rank|||The above two groups were compared.||0.41|0.02|<0.001
71093535|NCT01017250|141694561|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.04
71093536|NCT01017250|141694562|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.002
71093537|NCT01017250|141694563|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.02
71093538|NCT01017250|141694564|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.0005
71093539|NCT01017250|141694565|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.53
71093540|NCT01017250|141694566|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.002
71153996|NCT04934722|141800205|OTHER||Hazard Ratio (HR)|1.35|||||TWO_SIDED|95.0|0.5|3.63|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||3.63|0.50|
70971736|NCT00852995|141449588|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED|||||P-value for Kaplan Meier Days to Closure|ANCOVA|||||||0.10
71093541|NCT01017250|141694567|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.76
71093542|NCT01017250|141694568|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.34
71093543|NCT02112916|141694585|SUPERIORITY||Hazard Ratio (HR)|0.782||||0.074|TWO_SIDED|95.0|0.561|1.091|||Log Rank||Hazard ratio = hazard rate for Arm B/hazard rate for Arm A|To compare the EFS of the randomized patients (T-ALL+T-LLy) on Arm A vs Arm B. Study was designed to accrue 1200 eligible, evaluable randomized patients (to provide 90.5% power to detect an improvement in 4-year EFS from 85% to 90% with an alpha of 0.05 (one-sided log-rank test) (Hazard Ratio (HR)=0.6483). Study was closed to accrual early due to results from AALL0434 for nelarabine.||1.091|0.561|0.074
71093544|NCT04835441|141694597|SUPERIORITY|||||||0.107|||||||Cochran-Mantel-Haenszel|||||||0.107
71093545|NCT04835441|141694598|SUPERIORITY|||||||0.308|||||||Cochran-Mantel-Haenszel|||||||0.308
71093546|NCT04835441|141694599|SUPERIORITY|||||||0.442|||||||ANOVA|||||||0.442
71093547|NCT04835441|141694600|SUPERIORITY|||||||0.788|||||||Kaplan-Meier methods|||||||0.788
71093548|NCT04835441|141694601|SUPERIORITY|||||||0.792|||||||Cochran-Mantel-Haenszel|||||||0.792
71093549|NCT04835441|141694602|SUPERIORITY|||||||0.302|||||||Mixed models for repeated measures|||||||0.302
71093550|NCT04835441|141694603|SUPERIORITY|||||||0.506|||||||ANOVA|||||||0.506
71093551|NCT04835441|141694604|SUPERIORITY|||||||0.659|||||||Fisher Exact|||||||0.659
71093552|NCT03323502|141694626|SUPERIORITY||Incidence Rate Ratio (IRR)|0.94|STANDARD_ERROR_OF_MEAN|0.062||0.3164|TWO_SIDED|95.0|0.83|1.06|||Poisson Regression|||||1.06|0.83|0.3164
71093553|NCT03323502|141694627|SUPERIORITY||Odds Ratio (OR)|0.94||||0.4828|TWO_SIDED|95.0|0.8|1.11|||Regression, Logistic|||||1.11|0.80|0.4828
71093554|NCT03323502|141694628|SUPERIORITY||Odds Ratio (OR)|1.13||||0.3946|TWO_SIDED|95.0|0.85|1.49|||Regression, Logistic|||||1.49|0.85|0.3946
71093555|NCT06354257|141694671|EQUIVALENCE|The 90% CI for each ratio was compared to 0.8 and 1.25.|Geometric mean ratio|0.88|||||TWO_SIDED|90.0|0.55|1.41|||Mixed Models Analysis|Analysis was performed using linear mixed effect models with treatment as a fixed effect and subject as a random effect.|One-sided tests (alpha=0.05) were used. 90% CIs for each ratio were compared to 0.8-1.25. No drug interaction is shown if CIs for AUC(0-inf) and Cmax of EE and LNG fall within 0.8-1.25.|A confirmatory hypothesis testing to test the effect of GSK3036656 on the AUC(0-inf) of EE.||1.41|0.55|
71153997|NCT04934722|141800207|OTHER||Hazard Ratio (HR)|3.15|||||TWO_SIDED|95.0|0.33|30.29|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||30.29|0.33|
71093556|NCT06354257|141694671|EQUIVALENCE|The 90% CI for each ratio was compared to 0.8 and 1.25.|Geometric mean ratio|1.1|||||TWO_SIDED|90.0|0.98|1.23|||Mixed Models Analysis|Analysis was performed using linear mixed effect models with treatment as a fixed effect and subject as a random effect.|One-sided tests (alpha=0.05) were used. 90% CIs for each ratio were compared to 0.8-1.25. No drug interaction is shown if CIs for AUC(0-inf) and Cmax of EE and LNG fall within 0.8-1.25.|A confirmatory hypothesis testing to test the effect of GSK3036656 on the AUC(0-inf) of LNG.||1.23|0.98|
71093557|NCT06354257|141694672|EQUIVALENCE|The 90% CI for each ratio was compared to 0.8 and 1.25.|Geometric mean ratio|0.96|||||TWO_SIDED|90.0|0.85|1.09|||Mixed Models Analysis|Analysis was performed using linear mixed effect models with treatment as a fixed effect and subject as a random effect.|One-sided tests (alpha=0.05) were used. 90% CIs for each ratio were compared to 0.8-1.25. No drug interaction is shown if CIs for AUC(0-inf) and Cmax of EE and LNG fall within 0.8-1.25.|A confirmatory hypothesis testing to test the effect of GSK3036656 on the Cmax of EE.||1.09|0.85|
71093558|NCT06354257|141694672|EQUIVALENCE|The 90% CI for each ratio was compared to 0.8 and 1.25.|Geometric mean ratio|1.08|||||TWO_SIDED|90.0|0.97|1.19|||Mixed Models Analysis|Analysis was performed using linear mixed effect models with treatment as a fixed effect and subject as a random effect.|One-sided tests (alpha=0.05) were used. 90% CIs for each ratio were compared to 0.8-1.25. No drug interaction is shown if CIs for AUC(0-inf) and Cmax of EE and LNG fall within 0.8-1.25.|A confirmatory hypothesis testing to test the effect of GSK3036656 on the Cmax of LNG.||1.19|0.97|
71093559|NCT04738487|141694708|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.6712|TWO_SIDED|95.0|0.83|1.35||One-sided p-value based on log-rank test.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.35|0.83|0.6712
71093560|NCT04738487|141694709|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.332|TWO_SIDED|95.0|0.82|1.13||One-sided p-value based on log-rank test.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.13|0.82|0.3320
71153998|NCT04934722|141800208|OTHER||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.11|4.07|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||4.07|0.11|
70918898|NCT02528188|141328703|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.1||0.7179|TWO_SIDED|95.0|-0.23|0.16|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.16|-0.23|0.7179
70918899|NCT02528188|141328703|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.1||0.012|TWO_SIDED|95.0|-0.44|-0.05|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.44|0.0120
70918900|NCT02528188|141328703|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.11||0.5372|TWO_SIDED|95.0|-0.28|0.15|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.15|-0.28|0.5372
70918901|NCT02528188|141328703|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.11||0.0899|TWO_SIDED|95.0|-0.4|0.03|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.03|-0.40|0.0899
70918902|NCT02528188|141328703|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.13||0.7646|TWO_SIDED|95.0|-0.3|0.22|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.22|-0.30|0.7646
70918903|NCT02528188|141328703|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.13||0.2547|TWO_SIDED|95.0|-0.41|0.11|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.11|-0.41|0.2547
71093561|NCT04738487|141694710|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.1646|TWO_SIDED|95.0|0.72|1.11||One-sided p-value based on log-rank test.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.11|0.72|0.1646
71093562|NCT03824158|141694796|SUPERIORITY|||||||0.0014|||||||Mixed Models Analysis|||||||0.0014
71093563|NCT03824158|141694797|SUPERIORITY|||||||0.76|||||||Regression, Logistic|||||||0.76
71093564|NCT03824158|141694798|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||||||0.13
71153999|NCT04934722|141800209|OTHER||Hazard Ratio (HR)|1.45|||||TWO_SIDED|95.0|0.73|2.9|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||2.90|0.73|
70971737|NCT00852995|141449588|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.64||||0.06|TWO_SIDED|95.0|0.97|2.77||P-value for Cox Proportional Hazard Ratio|Regression, Cox|||||2.77|0.97|0.06
71093565|NCT03824158|141694799|SUPERIORITY|||||||0.008|||||||Mixed Models Analysis|||||||0.008
71093566|NCT03824158|141694800|SUPERIORITY|||||||0.002|||||||Chi-squared|||Advance directive or living will||||0.002
71093567|NCT03824158|141694800|SUPERIORITY|||||||0.02|||||||Fisher Exact|||POLST||||0.02
71093568|NCT03824158|141694800|SUPERIORITY|||||||0.78|||||||Chi-squared|||Code Status||||0.78
71093569|NCT03824158|141694800|SUPERIORITY|||||||0.61|||||||Chi-squared|||Goals of Care discussion||||0.61
71093570|NCT03824158|141694801|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||||||0.17
71093571|NCT03824158|141694802|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||||||0.11
71093572|NCT01260948|141694862|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.72|||||TWO_SIDED|90.0|94.13|103.53|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||103.53|94.13|
71093573|NCT01260948|141694863|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|94.81|||||TWO_SIDED|90.0|91.3|98.47|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||98.47|91.30|
71093574|NCT01706328|141694922|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.025||||0.137|TWO_SIDED|95.0|-0.008|0.059|||ANCOVA|||||0.059|-0.008|0.137
71093575|NCT03160170|141694925|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.96
71093576|NCT03160170|141694926|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
71093577|NCT03160170|141694927|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
71093578|NCT03018938|141694928|NON_INFERIORITY|If Lower limit (L) \>-0.4%, the Non-inferiority (NI) of basal insulin analog QD to insulin analog mid mixture BID is established; If Upper limit (U) \<0.4%, the NI of insulin analog mid mixture BID to basal insulin analog QD is established|LS Mean Difference (Final Values)|-0.158|STANDARD_ERROR_OF_MEAN|0.0959||0.1009|TWO_SIDED|95.0|-0.346|0.031|||ANCOVA|||||0.031|-0.346|0.1009
71093579|NCT03018938|141694929|SUPERIORITY||LS Mean Difference (Final Values)|-0.201|STANDARD_ERROR_OF_MEAN|0.0891||0.0246|TWO_SIDED|95.0|-0.376|-0.026|||ANCOVA|||||-0.026|-0.376|0.0246
71093580|NCT03018938|141694930|SUPERIORITY||Odds Ratio (OR)|1.34||||0.0941|TWO_SIDED|95.0|0.95|1.87|||Regression, Logistic|||||1.87|0.95|0.0941
71093581|NCT03018938|141694931|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8592|TWO_SIDED|95.0|0.72|1.49|||Regression, Logistic|||||1.49|0.72|0.8592
71093582|NCT03018938|141694932|SUPERIORITY||LS Mean Difference (Final Values)|0.423|STANDARD_ERROR_OF_MEAN|0.2152||0.0497|TWO_SIDED|95.0|0.0|0.846|||ANCOVA|||||0.846|0.000|0.0497
71093583|NCT03018938|141694933|SUPERIORITY||LS Mean Difference (Final Values)|0.647|STANDARD_ERROR_OF_MEAN|0.1955||0.001|TWO_SIDED|95.0|0.263|1.031|||ANCOVA|||||1.031|0.263|0.0010
71093584|NCT03018938|141694934|SUPERIORITY||LS Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.2191||0.2193|TWO_SIDED|95.0|-0.161|0.7|||ANCOVA|||FBG||0.700|-0.161|0.2193
71093585|NCT03018938|141694934|SUPERIORITY||LS Mean Difference (Final Values)|-0.084|STANDARD_ERROR_OF_MEAN|0.3331||0.8014|TWO_SIDED|95.0|-0.739|0.571|||ANCOVA|||PPG||0.571|-0.739|0.8014
71093586|NCT03018938|141694935|SUPERIORITY||LS Mean Difference (Final Values)|0.491|STANDARD_ERROR_OF_MEAN|0.2033||0.016|TWO_SIDED|95.0|0.092|0.891|||ANCOVA|||FBG||0.891|0.092|0.0160
71093587|NCT03018938|141694935|SUPERIORITY||LS Mean Difference (Final Values)|-0.013|STANDARD_ERROR_OF_MEAN|0.3028||0.9661|TWO_SIDED|95.0|-0.608|0.582|||ANCOVA|||PPG||0.582|-0.608|0.9661
71093588|NCT03018938|141694937|SUPERIORITY||LS Mean Difference|0.667|STANDARD_ERROR_OF_MEAN|0.2776||0.0166|TWO_SIDED|95.0|0.122|1.211|||ANCOVA|||||1.211|0.122|0.0166
71093589|NCT03018938|141694938|SUPERIORITY||LS Mean Difference (Final Values)|0.754|STANDARD_ERROR_OF_MEAN|0.2864||0.0086|TWO_SIDED|95.0|0.192|1.316|||ANCOVA|||||1.316|0.192|0.0086
71093590|NCT03018938|141694941|SUPERIORITY||Odds Ratio (OR)|1.25||||0.2009|TWO_SIDED|95.0|0.89|1.77|||Regression, Logistic|||||1.77|0.89|0.2009
71093591|NCT03018938|141694942|SUPERIORITY||Odds Ratio (OR)|1.05||||0.8054|TWO_SIDED|95.0|0.72|1.53|||Regression, Logistic|||||1.53|0.72|0.8054
71093592|NCT03018938|141694943|SUPERIORITY||LS Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.33||0.7553|TWO_SIDED|95.0|-0.8|0.5|||Mixed Models Analysis|||||0.5|-0.8|0.7553
71093593|NCT00191100|141694944|SUPERIORITY_OR_OTHER||PFS Probability Difference at 3 Years|0.095||||0.029||95.0|0.01|0.179||The p-value is two-sided and was tested at the 0.05 significance level.|Z Statistic||Difference in progression-free survival probability between Gem/Cis/Rad and Cis/Rad. The difference in PFS probability between the two treatment arms can also be presented as a percentage (ie, PFS at 3 years was 9.5% better in the Gem/Cis/Rad arm).|||0.179|0.010|0.029
71093594|NCT00191100|141694945|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||Log Rank|||||||0.0008
71093595|NCT00191100|141694946|SUPERIORITY_OR_OTHER|||||||0.096||95.0||||The p-value is two-sided and was tested at the 0.05 significance level.|Fisher Exact|||"Note: There were 2 patients with unknown site of progressive disease; these patients were counted as a Local failure.~Note: There was 1 patient with both local and distant failure; this patient was counted as a Local failure."||||0.096
71093596|NCT00191100|141694947|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||The p-value is two-sided and was tested at the 0.05 significance level.|Fisher Exact|||||||0.250
71093597|NCT00191100|141694948|SUPERIORITY_OR_OTHER|||||||0.0224||95.0|||||Log Rank|||||||0.0224
71093598|NCT00191100|141694949|SUPERIORITY_OR_OTHER|||||||0.0227||95.0|||||Log Rank|||||||0.0227
71093599|NCT01769586|141694950|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.38|||<|0.001|TWO_SIDED|95.0|0.24|0.5|||Chi-squared|||||.50|.24|<0.001
71093600|NCT02811159|141694951|OTHER|||||||0.1797|||||||Chi-Square Test|||||||0.1797
71093601|NCT02811159|141694952|OTHER|||||||0.125|||||||Wilcoxon Signed-Rank Test|||||||0.1250
71093602|NCT02811159|141694953|OTHER|||||||0.25|||||||Wilcoxon Signed-Rank Test|||||||0.2500
71093603|NCT02811159|141694954|OTHER|||||||0.5|||||||Wilcoxon Signed-Rank Test|||||||0.5000
71093604|NCT02811159|141694955|OTHER|||||||0.25|||||||Wilcoxon Signed-Rank Test|||||||0.2500
71093605|NCT02811159|141694956|OTHER|||||||1|||||||Wilcoxon Signed-Rank Test|||||||1.0000
71093606|NCT02811159|141694957|OTHER|||||||0.875|||||||Wilcoxon Signed-Rank Test|||||||0.8750
71093607|NCT02811159|141694958|OTHER|||||||0.5|||||||Wilcoxon Signed-Rank Test|||||||0.5000
71093608|NCT02811159|141694959|OTHER|||||||0.5|||||||Wilcoxon Signed-Rank Test|||||||0.5000
71093609|NCT02811159|141694960|OTHER|||||||0.25|||||||Wilcoxon Signed-Rank Test|||||||0.2500
71093610|NCT02811159|141694961|OTHER|||||||0.0645|||||||Wilcoxon Signed-Rank Test|||||||0.0645
71093611|NCT01525589|141694971|SUPERIORITY|||||||0.0909|||||||Log Rank|||||||0.0909
71093612|NCT01525589|141694975|SUPERIORITY|||||||0.002|||||||Log Rank|||||||0.002
71093613|NCT01525589|141694979|SUPERIORITY|||||||0.0561|||||||Log Rank|||||||0.0561
71093614|NCT04253626|141694997|OTHER||||||<|0.001||||||The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||||||< 0.001
70918904|NCT02528188|141328703|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.14||0.8806|TWO_SIDED|95.0|-0.29|0.25|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.25|-0.29|0.8806
71093615|NCT04253626|141695001|OTHER|||||||0.88||||||The a priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||Between-group analysis of change at week 4||||0.88
71093616|NCT04253626|141695002|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|The a priori threshold for statistical significance was \< 0.05.||Between-group analysis of change at week 4||||0.27
71093617|NCT04253626|141695003|OTHER|||||||0.72||||||The a priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||Between-group analysis of change at week 4||||0.72
71093618|NCT04253626|141695004|OTHER|||||||0.009||||||The a priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||Between-group analysis of change at week 4||||0.009
71093619|NCT05763875|141695007|SUPERIORITY||LS Mean Difference|-35.37|||<|0.0001|TWO_SIDED|95.0|-40.88|-29.86|||ANCOVA|||Treatment Policy Estimand||-29.86|-40.88|<0.0001
71093620|NCT05763875|141695007|SUPERIORITY||LS Mean Difference|-47.91|||<|0.0001|TWO_SIDED|95.0|-53.62|-42.2|||ANCOVA|||Treatment Policy Estimand||-42.20|-53.62|<0.0001
71093621|NCT05763875|141695007|SUPERIORITY||LS Mean Difference|-37.44|||<|0.0001|TWO_SIDED|95.0|-42.63|-32.26|||ANCOVA|||Monotherapy Estimand||-32.26|-42.63|<0.0001
71093622|NCT05763875|141695007|SUPERIORITY||LS Mean Difference|-50.9|||<|0.0001|TWO_SIDED|95.0|-56.51|-45.28|||ANCOVA|||Monotherapy Estimand||-45.28|-56.51|<0.0001
71093623|NCT05763875|141695008|SUPERIORITY||LS Mean Difference|-47.37|||<|0.0001|TWO_SIDED|95.0|-53.91|-40.72|||ANCOVA|||Treatment Policy Estimand||-40.72|-53.91|<0.0001
71093624|NCT05763875|141695008|SUPERIORITY||LS Mean Difference|-63.57|||<|0.0001|TWO_SIDED|95.0|-70.28|-56.87|||ANCOVA|||Treatment Policy Estimand||-56.87|-70.28|<0.0001
71093625|NCT05763875|141695008|SUPERIORITY||LS Mean Difference|-50.05|||<|0.0001|TWO_SIDED|95.0|-56.16|-43.94|||ANCOVA|||Monotherapy Estimand||-43.94|-56.16|<0.0001
71093626|NCT05763875|141695008|SUPERIORITY||LS Mean Difference|-67.51|||<|0.0001|TWO_SIDED|95.0|-74.09|-60.92|||ANCOVA|||Monotherapy Estimand||-60.92|-74.09|<0.0001
71093627|NCT05763875|141695009|SUPERIORITY||LS Mean Difference|-73.16|||<|0.0001|TWO_SIDED|95.0|-81.76|-64.56|||ANCOVA|||Treatment Policy Estimand||-64.56|-81.76|<0.0001
71093628|NCT05763875|141695009|SUPERIORITY||LS Mean Difference|-74.94|||<|0.0001|TWO_SIDED|95.0|-84.51|-65.37|||ANCOVA|||Treatment Policy Estimand||-65.37|-84.51|<0.0001
71093629|NCT05763875|141695009|SUPERIORITY||LS Mean Difference|-76.87|||<|0.0001|TWO_SIDED|95.0|-85.12|-68.62|||ANCOVA|||Monotherapy Estimand||-68.62|-85.12|<0.0001
71093630|NCT05763875|141695009|SUPERIORITY||LS Mean Difference|-79.47|||<|0.0001|TWO_SIDED|95.0|-88.77|-70.17|||ANCOVA|||Monotherapy Estimand||-70.17|-88.77|<0.0001
71093631|NCT05763875|141695010|SUPERIORITY||LS Mean Difference|-30.48|||<|0.0001|TWO_SIDED|95.0|-34.98|-25.98|||ANCOVA|||Treatment Policy Estimand||-25.98|-34.98|<0.0001
71093632|NCT05763875|141695010|SUPERIORITY||LS Mean Difference|-42.32|||<|0.0001|TWO_SIDED|95.0|-47.83|-36.82|||ANCOVA|||Treatment Policy Estimand||-36.82|-47.83|<0.0001
71093633|NCT05763875|141695010|SUPERIORITY||LS Mean Difference|-31.98|||<|0.0001|TWO_SIDED|95.0|-36.07|-27.89|||ANCOVA|||Monotherapy Estimand||-27.89|-36.07|<0.0001
71093634|NCT05763875|141695010|SUPERIORITY||LS Mean Difference|-44.86|||<|0.0001|TWO_SIDED|95.0|-50.28|-39.44|||ANCOVA|||Monotherapy Estimand||-39.44|-50.28|<0.0001
71093635|NCT05763875|141695011|SUPERIORITY||LS Mean Difference|-24.84|||<|0.0001|TWO_SIDED|95.0|-30.32|-19.36|||ANCOVA|||Treatment Policy Estimand||-19.36|-30.32|<0.0001
71093636|NCT05763875|141695011|SUPERIORITY||LS Mean Difference|-33.85|||<|0.0001|TWO_SIDED|95.0|-41.27|-26.44|||ANCOVA|||Treatment Policy Estimand||-26.44|-41.27|<0.0001
71093637|NCT05763875|141695011|SUPERIORITY||LS Mean Difference|-26.58|||<|0.0001|TWO_SIDED|95.0|-32.07|-21.09|||ANCOVA|||Monotherapy Estimand||-21.09|-32.07|<0.0001
71093638|NCT05763875|141695011|SUPERIORITY||LS Mean Difference|-36.06|||<|0.0001|TWO_SIDED|95.0|-43.46|-28.67|||ANCOVA|||Monotherapy Estimand||-28.67|-43.46|<0.0001
71093639|NCT05763875|141695012|SUPERIORITY||LS Mean Difference|-28.98|||<|0.0001|TWO_SIDED|95.0|-33.3|-24.65|||ANCOVA|||Treatment Policy Estimand||-24.65|-33.30|<0.0001
71093640|NCT05763875|141695012|SUPERIORITY||LS Mean Difference|-36.66|||<|0.0001|TWO_SIDED|95.0|-41.1|-32.22|||ANCOVA|||Treatment Policy Estimand||-32.22|-41.10|<0.0001
71093641|NCT05763875|141695012|SUPERIORITY||LS Mean Difference|-30.16|||<|0.0001|TWO_SIDED|95.0|-34.08|-26.23|||ANCOVA|||Monotherapy Estimand||-26.23|-34.08|<0.0001
71093642|NCT05763875|141695012|SUPERIORITY||LS Mean Difference|-38.78|||<|0.0001|TWO_SIDED|95.0|-43.12|-34.43|||ANCOVA|||Monotherapy Estimand||-34.43|-43.12|<0.0001
71093643|NCT05763875|141695013|SUPERIORITY||LS Mean Difference|-30.24|||<|0.0001|TWO_SIDED|95.0|-36.92|-23.57|||ANCOVA|||Treatment Policy Estimand||-23.57|-36.92|<0.0001
71093644|NCT05763875|141695013|SUPERIORITY||LS Mean Difference|-35.15|||<|0.0001|TWO_SIDED|95.0|-41.18|-29.12|||ANCOVA|||Treatment Policy Estimand||-29.12|-41.18|<0.0001
71093645|NCT05763875|141695013|SUPERIORITY||LS Mean Difference|-32.34|||<|0.0001|TWO_SIDED|95.0|-39.1|-25.59|||ANCOVA|||Monotherapy Estimand||-25.59|-39.10|<0.0001
71093646|NCT05763875|141695013|SUPERIORITY||LS Mean Difference|-37.38|||<|0.0001|TWO_SIDED|95.0|-43.44|-31.31|||ANCOVA|||Monotherapy Estimand||-31.31|-43.44|<0.0001
71093647|NCT05763875|141695014|SUPERIORITY||Ratio of Geometric Mean|0.757||||0.0002|TWO_SIDED|95.0|0.65|0.882|||ANCOVA|||Treatment Policy Estimand||0.882|0.650|0.0002
70971738|NCT03649061|141449589|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||To compare the two randomization groups, a linear mixed model with DAS28-CRP as outcome (Bell et al. 2014), including random intercepts per patient, adjusted for baseline DAS28-CRP, randomization timepoint, and RF and/or ACPA seropositivity was used.||||<0.05
70971739|NCT03649061|141449590|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||A binomial generalized linear mixed effect model for repeated measures of remission from randomization up until 28 weeks after was carried out, with adjustment for baseline DAS28-CRP, moment of randomization, and RF and/or ACPA seropositivity.||||<0.05
70971740|NCT01314716|141449613|SUPERIORITY_OR_OTHER||Differences in least squares mean|4.6||||0.011|TWO_SIDED|95.0|1.1|8.2||P-value was based on T-test from mixed-effect model repeated measures (MMRM).|MMRM|||||8.2|1.1|0.011
70971741|NCT01314716|141449614|SUPERIORITY_OR_OTHER||Difference in least squares mean|1.1||||0.56|TWO_SIDED|95.0|-2.7|5.0||P-value was based on T-test from mixed-effect model repeated measures (MMRM).|MMRM|||||5.0|-2.7|0.56
70971742|NCT00313209|141449632|SUPERIORITY_OR_OTHER||Mean Difference (Net)|49.0|STANDARD_ERROR_OF_MEAN|11.0|<|0.0001|TWO_SIDED|95.0|27.0|71.0||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||71|27|<0.0001
70971743|NCT00313209|141449633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|60.0|STANDARD_ERROR_OF_MEAN|11.0|<|0.0001|TWO_SIDED|95.0|38.0|82.0||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||82|38|<0.0001
70971744|NCT00313209|141449634|SUPERIORITY_OR_OTHER||Rate ratio|0.79|STANDARD_ERROR_OF_MEAN|0.12||0.1408|TWO_SIDED|95.0|0.58|1.08||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|Poisson regression|||||1.08|0.58|0.1408
70971745|NCT00313209|141449635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.4654|TWO_SIDED|95.0|-0.2|0.4||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||0.4|-0.2|0.4654
70971746|NCT00313209|141449636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|0.9||0.5457|TWO_SIDED|95.0|-1.2|2.2||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||2.2|-1.2|0.5457
70971747|NCT03784079|141449741|OTHER||Emax|-1.937|||||TWO_SIDED|95.0|-2.484|-1.389||||||||-1.389|-2.484|
70971748|NCT03784079|141449741|OTHER||EC50|7.094|||||TWO_SIDED|95.0|0.585|13.602||||||||13.602|0.585|
70971749|NCT03784079|141449741|OTHER||s2e|0.137|||||TWO_SIDED|95.0|0.062|0.212||||||||0.212|0.062|
71154000|NCT04934722|141800210|OTHER||Hazard Ratio (HR)|1.75|||||TWO_SIDED|95.0|0.42|7.34|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||7.34|0.42|
70971750|NCT03784079|141449742|OTHER||Emax|-1.929|||||TWO_SIDED|95.0|-2.479|-1.379||||||||-1.379|-2.479|
70971751|NCT03784079|141449742|OTHER||EC50|0.446|||||TWO_SIDED|95.0|0.03|0.861||||||||0.861|0.030|
70971752|NCT03784079|141449742|OTHER||s2e|0.139|||||TWO_SIDED|95.0|0.063|0.216||||||||0.216|0.063|
70971753|NCT03784079|141449743|OTHER||Emax|-1.926|||||TWO_SIDED|95.0|-2.498|-1.354||||||||-1.354|-2.498|
70971754|NCT03784079|141449743|OTHER||EC50|0.197|||||TWO_SIDED|95.0|0.007|0.386||||||||0.386|0.007|
70971755|NCT03784079|141449743|OTHER||s2e|0.144|||||TWO_SIDED|95.0|0.065|0.222||||||||0.222|0.065|
70971756|NCT04099251|141449752|SUPERIORITY||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.3|0.59|||Regression, Cox|||||0.59|0.30|< 0.0001
70971757|NCT02049944|141449780|OTHER|we used t-test on the regression coefficient for the group indicator to test for differences in means categorical variables were evaluated using fisher's exact test of association linear regression for log transformed start adipose concentrations were calculated by dose specific group|Median Difference (Final Values)|80.0|||||TWO_SIDED|95.0|||||Fisher Exact|||To detect the number of subjects who obtained a minimal inhibitory concentration (\>4mg/ml) following increased 3g dose of cefazolin. Compare this number to the historical cohort who had received 2g of cefazolin (standard dosing)||||
70971758|NCT01765673|141449781|OTHER|||||||0.218|||||||paired t test|||||||0.218
70971759|NCT01765673|141449782|OTHER|||||||0.017|||||||paired t test|||||||0.017
70971760|NCT01765673|141449783|OTHER|||||||0.022|||||||paired t test|||||||0.022
70971761|NCT01765673|141449784|OTHER|||||||0.719|||||||paired t test|||||||0.719
70971762|NCT01765673|141449785|OTHER|||||||0.418|||||||paired t test|||||||0.418
70971763|NCT01765673|141449786|OTHER|||||||0.038|||||||paired t test|||||||0.038
70971764|NCT01765673|141449787|OTHER|||||||0.086|||||||paired t test|||||||0.086
70971765|NCT01765673|141449788|OTHER|||||||0.16|||||||paired t test|||||||0.16
70971766|NCT01765673|141449789|OTHER|||||||0.052|||||||paired t test|||||||0.052
70971767|NCT01765673|141449790|OTHER|||||||0.827|||||||paired t test|||||||0.827
70971768|NCT01765673|141449791|OTHER|||||||0.088|||||||paired t test|||||||0.088
70971769|NCT01765673|141449792|OTHER|||||||0.152|||||||paired t test|||||||0.152
70971770|NCT01765673|141449793|OTHER|||||||0.229|||||||paired t test|||||||0.229
70971771|NCT01765673|141449794|OTHER|||||||0.121|||||||paired t test|||||||0.121
70971772|NCT01765673|141449795|OTHER|||||||0.239|||||||paired t test|||||||0.239
70971773|NCT01765673|141449796|OTHER|||||||0.03|||||||paired t test|||||||0.03
70971774|NCT01765673|141449797|OTHER|||||||0.067|||||||paired t test|||||||0.067
70971775|NCT01765673|141449798|OTHER|||||||0.396|||||||paired t test|||||||0.396
70971776|NCT01765673|141449799|OTHER|||||||0.373|||||||paired t test|||||||0.373
70971777|NCT01765673|141449800|OTHER|||||||0.744|||||||paired t test|||||||0.744
71008718|NCT02055976|141525246|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.447|STANDARD_ERROR_OF_MEAN|2.406||0.034|TWO_SIDED|95.0|-9.23|0.335|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||0.335|-9.230|0.034
70918905|NCT02528188|141328703|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8416|TWO_SIDED|95.0|-0.3|0.24|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.24|-0.30|0.8416
70918906|NCT02528188|141328703|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.9981|TWO_SIDED|95.0|-0.28|0.28|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.28|-0.28|0.9981
71031834|NCT01054586|141572352|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.67||||0.56||95.0|0.29|9.47||Only variables showing imbalance between treatments (when possible) were included. The following were also included, but p \> 0.05: gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV, Other. LPV is the reference group."|||9.47|0.29|0.56
71031835|NCT01054586|141572354|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.72||95.0|0.51|2.66||Only variables showing an imbalance between treatment groups were included: gender, mode of HIV transmission, ART naive, use of non-ARV drug, baseline bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||2.66|0.51|0.72
71031836|NCT01054586|141572354|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.27||||0.21||95.0|0.03|2.08||Only variables showing an imbalance between treatment groups were included: gender, mode of HIV transmission, ART naive, use of non-ARV drug, baseline bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||2.08|0.03|0.21
71031837|NCT01054586|141572354|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.26||||0.15||95.0|0.74|6.97|||Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV, other. LPV is the reference group."|Only variables showing an imbalance between treatment groups were included: gender, mode of HIV transmission, ART naive, use of non-ARV drug, baseline bilirubin.||6.97|0.74|0.15
71031838|NCT01054586|141572360|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.77||||0.1||95.0|0.79|18.05|||Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||18.05|0.79|0.10
71031839|NCT01054586|141572361|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.53||||0.02||95.0|1.16|5.54||Only variables showing an imbalance between the treatment groups were included, but p \> .05: gender, mode of HIV transmission, ART naive, APRI score, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||5.54|1.16|0.02
71031840|NCT01054586|141572361|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.17||||0.05||95.0|1.54|11.27||Only variables showing an imbalance between the treatment groups were included, but p \> .05: gender, mode of HIV transmission, ART naive, APRI score, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||11.27|1.54|0.05
71031841|NCT01054586|141572361|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.67||||0.06||95.0|0.97|13.9||Only variables showing an imbalance between the treatment groups were included, but p \> .05: gender, mode of HIV transmission, ART naive, APRI score, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV, other. LPV is the reference group."|||13.90|0.97|0.06
71031842|NCT01054586|141572362|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.68||||0.01||95.0|1.21|5.9||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||5.9|1.21|0.01
71031843|NCT01054586|141572362|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.42||||0.0004||95.0|1.61|12.08||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||12.08|1.61|0.0004
71031844|NCT01054586|141572362|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.07||||0.11||95.0|0.78|12.03||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV, other. LPV is the reference group."|||12.03|0.78|0.11
71031845|NCT01054586|141572363|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.09||||0.03||95.0|1.06|4.15||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, APRI-score, baseline use of non-ARV drug and baseline bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||4.15|1.06|0.03
71031846|NCT01054586|141572363|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.61||||0.05||95.0|1.48|8.81||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, APRI-score, baseline use of non-ARV drug and baseline bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||8.81|1.48|0.05
71031847|NCT01054586|141572363|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.31||||0.1||95.0|0.85|6.32||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, APRI-score, baseline use of non-ARV drug and baseline bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV, other. LPV is the reference group."|||6.32|0.85|0.10
71031848|NCT01054586|141572364|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.12||||0.03||95.0|1.19|22.02|||Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||22.02|1.19|0.03
70918907|NCT02528188|141328703|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.14||0.6485|TWO_SIDED|95.0|-0.21|0.34|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.34|-0.21|0.6485
70918908|NCT02528188|141328703|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8317|TWO_SIDED|95.0|-0.3|0.24|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.24|-0.30|0.8317
70918909|NCT02528188|141328703|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.14||0.5819|TWO_SIDED|95.0|-0.19|0.35|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.35|-0.19|0.5819
70918910|NCT02528188|141328703|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8538|TWO_SIDED|95.0|-0.26|0.31|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.31|-0.26|0.8538
70918911|NCT02528188|141328703|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.15||0.1981|TWO_SIDED|95.0|-0.1|0.47|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.47|-0.10|0.1981
70918912|NCT02528188|141328705|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.0846|TWO_SIDED|95.0|-0.33|0.02|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.02|-0.33|0.0846
70918913|NCT02528188|141328705|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.9749|TWO_SIDED|95.0|-0.18|0.17|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.17|-0.18|0.9749
70918914|NCT02528188|141328705|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.1||0.0076|TWO_SIDED|95.0|-0.45|-0.07|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.07|-0.45|0.0076
70918915|NCT02528188|141328705|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.1||0.0003|TWO_SIDED|95.0|-0.54|-0.16|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.16|-0.54|0.0003
70918916|NCT02528188|141328705|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.1||0.4402|TWO_SIDED|95.0|-0.27|0.12|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.12|-0.27|0.4402
70918917|NCT02528188|141328705|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.61|-0.21|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.21|-0.61|<0.0001
70918918|NCT02528188|141328705|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.11||0.1543|TWO_SIDED|95.0|-0.38|0.06|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.06|-0.38|0.1543
71008719|NCT02055976|141525246|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.764|STANDARD_ERROR_OF_MEAN|2.442||0.003|TWO_SIDED|95.0|-11.617|-1.91|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.910|-11.617|0.003
71093648|NCT05763875|141695014|SUPERIORITY||Ratio of Geometric Mean|0.748||||0.001|TWO_SIDED|95.0|0.622|0.898|||ANCOVA|||Treatment Policy Estimand||0.898|0.622|0.0010
71093649|NCT05763875|141695014|SUPERIORITY||Ratio of Geometric Mean|0.753|||<|0.0001|TWO_SIDED|95.0|0.652|0.871|||ANCOVA|||Monotherapy Estimand||0.871|0.652|<0.0001
71093650|NCT05763875|141695014|SUPERIORITY||Ratio of Geometric Mean|0.746||||0.0008|TWO_SIDED|95.0|0.622|0.893|||ANCOVA|||Monotherapy Estimand||0.893|0.622|0.0008
71093651|NCT00217737|141695016|SUPERIORITY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.63|1.11|||||Hazard ratio: Arm B/Arm A|||1.11|0.63|
71093652|NCT04132050|141695020|SUPERIORITY||Difference in Percent of Participants|36.4||||0.03|TWO_SIDED|95.0|3.1|59.3|||Fisher Exact||"The difference in the achievement rate of Stable platelet response (= platelet count of ≥ 50000/μL at 4 or more of the 6 visits from Weeks 14 to 24) between two groups and its two-sided 95% CI were calculated."|||59.3|3.1|0.030
71093653|NCT00843882|141695033|SUPERIORITY|||||||0.004|||||||Fisher Exact|||||||0.004
71093654|NCT00843882|141695042|SUPERIORITY|||||||0.0002|||||||Wilcoxon (Mann-Whitney)|||||||0.0002
71093655|NCT05317546|141695046|SUPERIORITY|We used linear mixed effects models containing the main effect of medication (CBD vs. placebo), visit (visit 1 vs. visit 2), and sequence (CBD/placebo vs. placebo/CBD) with random intercepts. For 1H-MRS models, brain tissue composition \[Gray Matter: Brain Matter or GM:BM defined as GM/(GM+WM)\] was included as a covariate.||||||0.33||||||alpha \< 0.05|Mixed Models Analysis|Adjusted for brain tissue composition||An a priori power analysis was conducted to ensure power to detect differences in neurometabolite levels in the dACC. Due to type of modeling, participants were included even if they did not complete the second medication allocation.||||0.33
71093656|NCT05317546|141695047|SUPERIORITY|We used linear mixed effects models containing the main effect of medication (CBD vs. placebo), visit (visit 1 vs. visit 2), and sequence (CBD/placebo vs. placebo/CBD) with random intercepts. For 1H-MRS models, brain tissue composition \[Gray Matter: Brain Matter or GM:BM defined as GM/(GM+WM)\] was included as a covariate.||||||0.75||||||alpha \<0.05|Mixed Models Analysis|Adjusted for brain tissue composition||Due to type of modeling, participants were included even if they did not complete the second medication allocation.||||0.75
71093657|NCT05317546|141695048|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Several studies have demonstrated that CBD can modulate resting-state or task-based BOLD signal under similar study design (acute dosing, 600 mg CBD) with sample sizes smaller than our sample. Due to the modeling, only participants with usable data from both medication allocation visits were included. Contrast of interest was alcohol beverages vs. non-alcohol beverages.||||>0.05
71093658|NCT05317546|141695049|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||We were not able to complete a power calculation for this task. We used linear mixed effects models, containing the main effect of medication (CBD vs. placebo), visit (visit 1 vs. visit 2), and sequence (CBD/placebo vs. placebo/CBD) and cue-by-medication interaction terms. Random intercepts were included to account for individual differences.||||0.82
71154001|NCT04934722|141800211|OTHER||Percent Difference|-5.5|||||TWO_SIDED|95.0|-12.6|0.0|||||Percent difference and associated 95% CI were calculated using Miettinen \& Nurminen method.|||0.0|-12.6|
70918919|NCT02528188|141328705|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.11||0.0053|TWO_SIDED|95.0|-0.53|-0.09|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.09|-0.53|0.0053
70918920|NCT02528188|141328705|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.14||0.6445|TWO_SIDED|95.0|-0.33|0.2|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.20|-0.33|0.6445
71093659|NCT05317546|141695050|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||We were not able to complete a power calculation for this task. We used linear mixed effects models, containing the main effect of medication (CBD vs. placebo), visit (visit 1 vs. visit 2), and sequence (CBD/placebo vs. placebo/CBD) and cue-by-medication interaction terms. Random intercepts were included to account for individual differences.||||0.21
71093660|NCT04590963|141695055|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.989|TWO_SIDED|95.0|0.66|1.537|||Log Rank|P-value was calculated using stratified log-rank test, adjusted for WHO/ECOG PS (0/1) and number of prior lines of therapy in R/M setting.|HR and CIs were calculated using a stratified Cox proportional hazards model, adjusted for WHO/ECOG PS, and number of lines of prior therapy in R/M setting.|||1.537|0.660|0.989
71093661|NCT04590963|141695056|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.891|TWO_SIDED|95.0|0.704|1.528|||Log Rank|P-value was calculated using stratified log-rank test, adjusted for HPV status, WHO/ECOG PS (0/1) and number of prior lines of therapy in R/M setting.|HR and CIs were calculated using a stratified Cox proportional hazards model, adjusted for HPV status, WHO/ECOG PS, and number of lines of prior therapy in R/M setting.|||1.528|0.704|0.891
71093662|NCT04590963|141695057|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.574|TWO_SIDED|95.0|0.79|1.568|||Log Rank|P-value was calculated using stratified log-rank test, adjusted for WHO/ECOG PS (0/1) and number of prior lines of therapy in R/M setting.|HR and CIs were calculated using a stratified Cox proportional hazards model, adjusted for WHO/ECOG PS, and number of lines of prior therapy in R/M setting.|||1.568|0.790|0.574
71093663|NCT04590963|141695058|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.53|TWO_SIDED|95.0|0.818|1.512|||Log Rank|P-value was calculated using stratified log-rank test, adjusted for HPV status, WHO/ECOG PS (0/1) and number of prior lines of therapy in R/M setting.|HR and CIs were calculated using a stratified Cox proportional hazards model, adjusted for HPV status, WHO/ECOG PS, and number of lines of prior therapy in R/M setting.|||1.512|0.818|0.530
71093664|NCT04590963|141695059|SUPERIORITY||Odds Ratio (OR)|0.56||||0.115|TWO_SIDED|95.0|0.274|1.154|||Regression, Logistic|P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|The analysis was performed using a logistic regression model, with treatment as a covariate and adjusting for WHO/ECOG PS, and number of lines of prior therapy in the R/M setting with 95% CI calculated by profile likelihood.|||1.154|0.274|0.115
71154002|NCT04934722|141800212|OTHER||Percent difference|-0.7|||||TWO_SIDED|95.0|-15.0|13.7|||||Percent difference and associated 95% CI were calculated using Miettinen \& Nurminen method.|||13.7|-15.0|
70971778|NCT00621504|141449830|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% Confidence Interval (CI) for the observed difference in the primary outcome measure (clinical cure rate) between the ceftaroline group and the ceftriaxone group was calculated based on each of the CE and the MITTE Populations at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10% for each of the CE and MITTE Populations.|Risk Difference (RD)|6.2|||||TWO_SIDED|95.0|-0.2|12.6|||||Risk difference corresponds to Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The confidence interval was calculated using the Miettinen and Nurminen method without adjustment.|The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared to that for ceftriaxone at TOC in the CE and MITTE Populations in adult subjects with CABP.||12.6|-0.2|
70971779|NCT03257267|141449853|SUPERIORITY||Hazard Ratio (HR)|0.665|||<|1e-05|TWO_SIDED|95.0|0.555|0.796||One-sided p-value|Stratified Log-rank Test|||||0.796|0.555|<0.00001
70971780|NCT03257267|141449854|SUPERIORITY||Hazard Ratio (HR)|0.741||||0.00031|TWO_SIDED|95.0|0.623|0.882|||Stratified Log-rank Test|||||0.882|0.623|0.00031
70971781|NCT03257267|141449855|SUPERIORITY||Odds Ratio (OR)|3.136||||2e-05|TWO_SIDED|95.0|1.798|5.468|||Stratified Cochran-Mantel-Haenszel test|||||5.468|1.798|0.00002
70971782|NCT03257267|141449860|SUPERIORITY||Hazard Ratio (HR)|0.698||||0.00024|TWO_SIDED|95.0|0.57|0.855||One-sided p-value|Stratified Log-rank Test|||||0.855|0.570|0.00024
70971783|NCT01979523|141449861|OTHER|||||||0.74|||||||Log Rank|||||||0.74
70971784|NCT03657368|141449874|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.042|TWO_SIDED|97.5|-0.4|7.3|||Regression, Linear|||||7.3|-0.4|0.042
70971785|NCT03657368|141449874|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.966|TWO_SIDED|97.5|-3.9|3.7|||Regression, Linear|||||3.7|-3.9|0.966
70971786|NCT03657368|141449875|SUPERIORITY||Odds Ratio (OR)|0.93||||0.519|TWO_SIDED|99.2|0.68|1.27|||Regression, Logistic|||||1.27|0.68|0.519
70971787|NCT03657368|141449875|SUPERIORITY||Odds Ratio (OR)|0.87||||0.232|TWO_SIDED|99.2|0.63|1.19|||Regression, Logistic|||||1.19|0.63|0.232
70971788|NCT03657368|141449876|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.217|TWO_SIDED|99.2|-6.5|2.4|||Regression, Linear|||||2.4|-6.5|0.217
70918921|NCT02528188|141328705|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1439|TWO_SIDED|95.0|-0.47|0.07|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.07|-0.47|0.1439
70971789|NCT03657368|141449876|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.66|TWO_SIDED|99.2|-3.7|5.2|||Regression, Linear|||||5.2|-3.7|0.660
70971790|NCT03657368|141449877|SUPERIORITY||mean ratio|1.03||||0.143|TWO_SIDED|99.2|0.97|1.1|||Mixed Models Analysis|||||1.10|0.97|0.143
70971791|NCT03657368|141449877|SUPERIORITY||mean ratio|0.99||||0.649|TWO_SIDED|99.2|0.93|1.05|||Regression, Logistic|||||1.05|0.93|0.649
70971792|NCT01623271|141449880|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
70971793|NCT01982292|141449887|SUPERIORITY_OR_OTHER||Difference in percentage|0.5|||>|0.9999|TWO_SIDED|90.0|-9.38|10.38|||Fisher Exact|||Difference in percentage of patients with positive antibody status||10.38|-9.38|>0.9999
70971794|NCT01982292|141449887|SUPERIORITY_OR_OTHER||Difference in percentage|-0.5|||||TWO_SIDED|90.0|-10.38|9.38||||||Difference in percentage of patients with negative antibody status||9.38|-10.38|
70971795|NCT01745146|141449912|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.047||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for STAXI-2 Trait Anger. Missing outcomes reported at non-responders.||||0.047
70971796|NCT01745146|141449912|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.549||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for STAXI-2 Anger Expression-Out. Missing outcomes reported at non-responders.||||0.549
70971797|NCT01745146|141449912|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.511||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for BAAQ. Missing outcomes reported at non-responders.||||0.511
70971798|NCT01745146|141449912|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.031||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for STAXI-2 Trait Anger. Missing outcomes excluded for this analysis.||||0.031
71008720|NCT02055976|141525246|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.951|STANDARD_ERROR_OF_MEAN|2.458||0.009|TWO_SIDED|95.0|-10.836|-1.066|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.066|-10.836|0.009
70918922|NCT02528188|141328705|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8402|TWO_SIDED|95.0|-0.3|0.25|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.25|-0.30|0.8402
70971799|NCT01745146|141449912|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.483||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for STAXI-2 Anger Expression-Out. Missing outcomes excluded for this analysis.||||0.483
70918923|NCT02528188|141328705|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.14||0.4439|TWO_SIDED|95.0|-0.38|0.17|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.17|-0.38|0.4439
70918924|NCT02528188|141328705|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.14||0.9376|TWO_SIDED|95.0|-0.27|0.29|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.29|-0.27|0.9376
70918925|NCT02528188|141328705|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7614|TWO_SIDED|95.0|-0.33|0.24|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.24|-0.33|0.7614
70918926|NCT02528188|141328705|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.15||0.8081|TWO_SIDED|95.0|-0.32|0.25|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.25|-0.32|0.8081
70918927|NCT02528188|141328705|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.15||0.8078|TWO_SIDED|95.0|-0.25|0.33|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.33|-0.25|0.8078
70918928|NCT02528188|141328705|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.15||0.9705|TWO_SIDED|95.0|-0.28|0.29|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.29|-0.28|0.9705
70971800|NCT01745146|141449912|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.53||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for BAAQ. Missing outcomes excluded for this analysis.||||0.530
70971801|NCT01745146|141449912|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.421||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's Chi-squared||Significance of difference in overall post-treatment response rate. Missing outcomes included as non-responders.||||0.421
70971802|NCT01745146|141449912|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.332||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's Chi-squared||Significance of difference in overall post-treatment response rate. Missing outcomes excluded for this analysis.||||0.332
70971803|NCT04623242|141449913|SUPERIORITY||Ratio|1.063|STANDARD_DEVIATION|0.059|||TWO_SIDED|||||A priori threshold for statistical significance||||||||
70971804|NCT04623242|141449913|SUPERIORITY||Ratio|1.255|STANDARD_DEVIATION|0.061|||TWO_SIDED|||||A priori threshold for statistical significance||||||||
70971805|NCT04623242|141449914|OTHER||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|1.094||0.805|TWO_SIDED|95.0|-2.46|1.92|||t-test, 2 sided|||||1.92|-2.46|0.805
71154003|NCT04934722|141800213|OTHER||Percent difference|7.8|||||TWO_SIDED|95.0|-12.5|27.1|||||Percent difference and associated 95% CI were calculated using Miettinen \& Nurminen method.|||27.1|-12.5|
71093665|NCT04590963|141695060|SUPERIORITY||Odds Ratio (OR)|0.6||||0.162|TWO_SIDED|95.0|0.297|1.231|||Regression, Logistic|P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|The analysis was performed using a logistic regression model, with treatment as a covariate and adjusting for HPV Status, WHO/ECOG PS, and number of lines of prior therapy in the R/M setting with 95% CI calculated by profile likelihood.|||1.231|0.297|0.162
71093666|NCT01063114|141695067|OTHER||3-Year Cumulative incidence|26.0|||||TWO_SIDED|95.0|16.0|37.0||||||||37|16|
70971806|NCT04623242|141449915|OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|1.823||0.512|TWO_SIDED|95.0|-4.83|2.43|||t-test, 2 sided|||Test of equality (any treatment difference)||2.43|-4.83|0.512
70971807|NCT04623242|141449916|OTHER|Test of equality (any treatment difference)|Median Difference (Final Values)|-0.641|STANDARD_ERROR_OF_MEAN|0.1115|<|0.001|TWO_SIDED|95.0|-0.864|-0.417|||t-test, 2 sided|||||-0.417|-0.864|<0.001
70971808|NCT04623242|141449917|OTHER|Test of equality (any difference in the proportion of increase in the endpoint)|Ratio|0.3443||||0.5573|TWO_SIDED||||||Chi-squared|||||||0.5573
70971809|NCT04623242|141449918|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|1.092||0.707|TWO_SIDED|95.0|-1.77|2.6|||t-test, 2 sided|||||2.60|-1.77|0.707
70971810|NCT04623242|141449919|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.44||0.283|TWO_SIDED|95.0|-1.35|0.4|||t-test, 2 sided|||||0.40|-1.35|0.283
70971811|NCT04623242|141449920|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.859||0.674|TWO_SIDED|95.0|-1.34|2.07|||t-test, 2 sided|||||2.07|-1.34|0.674
70971812|NCT04623242|141449921|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1.22|STANDARD_ERROR_OF_MEAN|1.828||0.507|TWO_SIDED|95.0|-4.86|2.42|||t-test, 2 sided|||||2.42|-4.86|0.507
70971813|NCT04623242|141449922|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|1.706||0.553|TWO_SIDED|95.0|-4.41|2.38|||t-test, 2 sided|||||2.38|-4.41|0.553
70971814|NCT04623242|141449923|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.596||0.098|TWO_SIDED|95.0|-2.18|0.19|||t-test, 2 sided|||||0.19|-2.18|0.098
70971815|NCT04623242|141449924|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|2.73|STANDARD_ERROR_OF_MEAN|1.98||0.173|TWO_SIDED|95.0|-1.22|6.68|||t-test, 2 sided|||||6.68|-1.22|0.173
71154004|NCT06072170|141800223|OTHER|Proportionality analysis was done using a power model.|Slope|0.829|||||TWO_SIDED|90.0|0.659|0.998||||||Statistical Analysis for Dose-Proportionality of Mitragynine Pharmacokinetic Parameters (Pharmacokinetic Population)||0.998|0.659|
70971816|NCT04623242|141449925|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|3.998||0.94|TWO_SIDED|95.0|-8.1|8.71|||t-test, 2 sided|||||8.71|-8.10|0.940
70971817|NCT04623242|141449926|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|3.07|STANDARD_ERROR_OF_MEAN|16.524||0.854|TWO_SIDED|95.0|-30.49|36.62|||t-test, 2 sided|||||36.62|-30.49|0.854
70971818|NCT04623242|141449927|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|4.88|STANDARD_ERROR_OF_MEAN|17.448||0.781|TWO_SIDED|95.0|-30.0|39.75|||t-test, 2 sided|||||39.75|-30.00|0.781
70971819|NCT04623242|141449928|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1.69|STANDARD_ERROR_OF_MEAN|4.21||0.689|TWO_SIDED|95.0|-10.05|6.67|||t-test, 2 sided|||||6.67|-10.05|0.689
70971820|NCT04623242|141449929|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.689||0.474|TWO_SIDED|95.0|-1.86|0.87|||t-test, 2 sided|||||0.87|-1.86|0.474
70971821|NCT04623242|141449930|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.637||0.886|TWO_SIDED|95.0|-1.36|1.17|||t-test, 2 sided|||||1.17|-1.36|0.886
70971822|NCT04623242|141449931|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.556||0.873|TWO_SIDED|95.0|-1.03|1.2|||t-test, 2 sided|||||1.20|-1.03|0.873
70971823|NCT04623242|141449932|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1.42|STANDARD_ERROR_OF_MEAN|1.66||0.394|TWO_SIDED|95.0|-4.71|1.87|||t-test, 2 sided|||||1.87|-4.71|0.394
70971824|NCT04623242|141449933|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|1.063||0.776|TWO_SIDED|95.0|-2.41|1.81|||t-test, 2 sided|||||1.81|-2.41|0.776
70971825|NCT04623242|141449934|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.909||0.283|TWO_SIDED|95.0|-2.78|0.82|||t-test, 2 sided|||||0.82|-2.78|0.283
70971826|NCT04623242|141449935|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.947||0.634|TWO_SIDED|95.0|-2.33|1.42|||t-test, 2 sided|||||1.42|-2.33|0.634
70971827|NCT04623242|141449936|SUPERIORITY||Ratio|1.155|STANDARD_DEVIATION|0.074|||TWO_SIDED|||||A priori threshold for statistical significance||||||||
70971828|NCT04623242|141449937|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.0562||0.726|TWO_SIDED|95.0|-0.093|0.132|||t-test, 2 sided|||||0.132|-0.093|0.726
70971829|NCT04623242|141449938|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.1056||0.439|TWO_SIDED|95.0|-0.13|0.295|||t-test, 2 sided|||||0.295|-0.130|0.439
70971830|NCT04623242|141449939|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.0168||0.967|TWO_SIDED|95.0|-0.034|0.033|||t-test, 2 sided|||||0.033|-0.034|0.967
70971831|NCT04623242|141449940|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.0377||0.669|TWO_SIDED|95.0|-0.059|0.092|||t-test, 2 sided|||||0.092|-0.059|0.669
71093667|NCT01063114|141695067|OTHER||5-Year Cumulative incidence|27.0|||||TWO_SIDED|95.0|17.0|38.0||||||||38|17|
71093668|NCT01063114|141695068|OTHER||3-Year Cumulative incidence|46.0|||||TWO_SIDED|95.0|34.0|57.0||||||||57|34|
71093669|NCT01063114|141695068|OTHER||5-Year Cumulative incidence|67.0|||||TWO_SIDED|95.0|54.0|77.0||||||||77|54|
71093670|NCT01063114|141695069|OTHER||Mean Difference (Net)|-11.0||||0.01024|TWO_SIDED|95.0|-19.2|-2.9|||t-test, 2 sided|Paired t test||||-2.9|-19.2|0.01024
71093671|NCT01063114|141695070|OTHER||3-Year Survival Probability|83.2|||||TWO_SIDED|95.0|75.8|91.3||||||||91.3|75.8|
71093672|NCT01063114|141695070|OTHER||5-Year Survival Probability|79.6|||||TWO_SIDED|95.0|71.7|88.5||||||||88.5|71.7|
71093673|NCT03409367|141695104|EQUIVALENCE|The risk ratio is equal to 1.|Risk Ratio (RR)|0.84||||0.019|TWO_SIDED|95.0|0.73|0.97|||Regression, log-binomial||Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations.|The null hypothesis is that the cumulative incidence of atopic dermatitis does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio is equal to 1.||0.97|0.73|0.019
70971832|NCT04623242|141449941|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-34.46|STANDARD_ERROR_OF_MEAN|116.419||0.768|TWO_SIDED|95.0|-264.14|195.22|||t-test, 2 sided|||||195.22|-264.14|0.768
70971833|NCT04623242|141449943|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-2737.62|STANDARD_ERROR_OF_MEAN|6558.467||0.677|TWO_SIDED|95.0|-15678.06|10202.81|||t-test, 2 sided|||||10202.81|-15678.06|0.677
70971834|NCT04623242|141449944|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1078.32|STANDARD_ERROR_OF_MEAN|1788.474||0.547|TWO_SIDED|95.0|-4603.28|2446.64|||t-test, 2 sided|||||2446.64|-4603.28|0.547
70971835|NCT04623242|141449945|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1935.91|STANDARD_ERROR_OF_MEAN|385.538|<|0.001|TWO_SIDED|95.0|-2717.64|-1154.18|||t-test, 2 sided|||||-1154.18|-2717.64|<0.001
70971836|NCT04623242|141449946|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-77.12|STANDARD_ERROR_OF_MEAN|23.014||0.003|TWO_SIDED|95.0|-124.56|-29.68|||t-test, 2 sided|||||-29.68|-124.56|0.003
70971837|NCT04623242|141449947|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|30.89|STANDARD_ERROR_OF_MEAN|35.54||0.388|TWO_SIDED|95.0|-40.04|101.83|||t-test, 2 sided|||||101.83|-40.04|0.388
70971838|NCT04623242|141449948|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|6.624||0.909|TWO_SIDED|95.0|-13.97|12.45|||t-test, 2 sided|||||12.45|-13.97|0.909
70971839|NCT04623242|141449949|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.0593||0.004|TWO_SIDED|95.0|0.059|0.296|||t-test, 2 sided|||||0.296|0.059|0.004
70971840|NCT04623242|141449950|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|1.355||0.754|TWO_SIDED|95.0|-3.21|2.35|||t-test, 2 sided|||||2.35|-3.21|0.754
70971841|NCT04623242|141449952|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|229362.3|STANDARD_ERROR_OF_MEAN|14863.08|<|0.001|TWO_SIDED|95.0|199264.32|259460.27|||t-test, 2 sided|||||259460.27|199264.32|<0.001
70971842|NCT04623242|141449953|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|32906.6|STANDARD_ERROR_OF_MEAN|1697.541|<|0.001|TWO_SIDED|95.0|29406.49|36406.72|||t-test, 2 sided|||||36406.72|29406.49|<0.001
70971843|NCT04623242|141449954|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|1286.35|STANDARD_ERROR_OF_MEAN|140.692|<|0.001|TWO_SIDED|95.0|1002.79|1569.9|||t-test, 2 sided|||||1569.90|1002.79|<0.001
70971844|NCT04623242|141449955|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|9867.26|STANDARD_ERROR_OF_MEAN|1212.232|<|0.001|TWO_SIDED|95.0|7419.38|12315.15|||t-test, 2 sided|||||12315.15|7419.38|<0.001
70971845|NCT01968460|141449960|SUPERIORITY||Mean Difference (Net)|-4.67|STANDARD_ERROR_OF_MEAN|1.28||0.0004|TWO_SIDED|95.0|-7.2|-2.13||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|MMRM|||||-2.13|-7.20|0.0004
70971846|NCT01968460|141449960|SUPERIORITY||Mean Difference (Net)|-3.84|STANDARD_ERROR_OF_MEAN|1.25||0.0027|TWO_SIDED|95.0|-6.32|-1.36||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|MMRM|||||-1.36|-6.32|0.0027
70971847|NCT01968460|141449961|SUPERIORITY||Mean Difference (Net)|-1.85|STANDARD_ERROR_OF_MEAN|0.51||0.0004|TWO_SIDED|95.0|-2.86|-0.84||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|MMRM|||||-0.84|-2.86|0.0004
70971848|NCT01968460|141449961|SUPERIORITY||Mean Difference (Net)|-1.42|STANDARD_ERROR_OF_MEAN|0.01||0.005|TWO_SIDED|95.0|-2.41|0.44||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|MMRM|||||0.44|-2.41|0.005
70971849|NCT01968460|141449962|SUPERIORITY||Odds Ratio (OR)|8.1||||0.0165|TWO_SIDED|95.0|1.47|44.77||The overall significance level for this study was 5% using two-tailed tests.|Regression, Logistic|||A subject will be defined as a treatment responder in case that the improvement from baseline to the Week12 / Last Observed Value (LOV) in the CGI-S will be of 1 point or more. Baseline adjusted logistic regression (SAS® LOGISTIC procedure) stratified by GeoSite using the STRATA sub-command with the following effects: treatment group and baseline CGI-S measurement was used to test the between the active groups and placebo contrasts.||44.77|1.47|0.0165
71093674|NCT03409367|141695105|EQUIVALENCE|The risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.76||||0.002|TWO_SIDED|95.0|0.65|0.9|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations.||The null hypothesis is that the cumulative incidence of parent-reported AD does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||0.90|0.65|0.002
71154005|NCT06072170|141800223|OTHER|Proportionality analysis was done using a power model.|Slope|0.843|||||TWO_SIDED|90.0|0.713|0.973||||||Statistical Analysis for Dose-Proportionality of 7-Hydroxy-Mitragynine Pharmacokinetic Parameters (Pharmacokinetic Population)||0.973|0.713|
70971850|NCT01968460|141449962|SUPERIORITY||Odds Ratio (OR)|4.23|STANDARD_ERROR_OF_MEAN|0.9||0.111|TWO_SIDED|95.0|0.72|24.9||The overall significance level for this study will be 5% using two-tailed tests.|Regression, Logistic|||||24.90|0.72|0.111
70971851|NCT01968460|141449963|SUPERIORITY||Mean Difference (Net)|-2.81|STANDARD_ERROR_OF_MEAN|1.0||0.0058|TWO_SIDED|95.0|-4.8|-0.83||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|MMRM|||||-0.83|-4.80|0.0058
70971852|NCT01968460|141449963|SUPERIORITY||Mean Difference (Net)|-2.32|STANDARD_ERROR_OF_MEAN|0.98||0.0191|TWO_SIDED|95.0|-4.26|-0.39||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|MMRM|||||-0.39|-4.26|0.0191
71093675|NCT03409367|141695106|EQUIVALENCE|Risk ratio is equal to 1.|Risk Ratio (RR)|0.86||||0.323|TWO_SIDED|95.0|0.65|1.15||Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations.|Regression, log-binomial|||The null hypothesis is that the cumulative incidence of AD by modified UK Working Party criteria does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||1.15|0.65|0.323
71093676|NCT03409367|141695107|EQUIVALENCE|Risk ratio is equal to 1.|Risk Ratio (RR)|0.83||||0.044|TWO_SIDED|95.0|0.7|0.99|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations.||The null hypothesis is that the cumulative incidence of AD by CEQ does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||0.99|0.70|0.044
71093677|NCT03409367|141695108|EQUIVALENCE|The risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.68||||0.0004|TWO_SIDED|95.0|0.55|0.84|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations.||The null hypothesis is that the cumulative incidence of AD with prescription or OTC therapies in the health record does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||0.84|0.55|0.0004
71093678|NCT03409367|141695109|EQUIVALENCE|The odds ratio (OR) is equal to 1. An OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD, as operationalized here by the type of recommended treatment.|Odds Ratio (OR)|0.7||||0.004|TWO_SIDED|95.0|0.55|0.89||Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations of 199 missing outcomes.|Regression, proportional odds|||The null hypothesis is that the odds of belonging to the next higher category of severity are equal in the Daily Emollient and Natural Skin arms.||0.89|0.55|0.004
71093679|NCT03409367|141695110|EQUIVALENCE|Odds ratio (OR) is equal to 1. An OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD, as operationalized here by the type of treatment.|Odds Ratio (OR)|0.72||||0.013|TWO_SIDED|95.0|0.56|0.93|||Regression, proportional odds|Adjusted for family history of atopy (stratified randomization) and primary care site.||The null hypothesis is that the odds of belonging to the next higher category of severity are equal in the Daily Emollient and Natural Skin arms.||0.93|0.56|0.013
71093680|NCT03409367|141695111|EQUIVALENCE|The risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.92||||0.509|TWO_SIDED|95.0|0.73|1.17|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site.||The null hypothesis is that the cumulative incidence of skin infections in the health record does not differ between the Daily Emollient and Natural Skin arms.||1.17|0.73|0.509
71093681|NCT03409367|141695112|EQUIVALENCE|The risk ratio is equal to 1.|Risk Ratio (RR)|1.05||||0.9|TWO_SIDED|95.0|0.5|2.18|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site.||The null hypothesis is that the cumulative incidence of asthma in the health record does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||2.18|0.50|0.900
71093682|NCT03409367|141695113|EQUIVALENCE|An ordinal OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD symptoms among those diagnosed with AD.|Odds Ratio (OR)|1.47||||0.064|TWO_SIDED|95.0|0.98|2.21|||Regression, proportional odds|Adjusted for family history of atopy (stratified randomization).|The daily emollient is in the numerator and the natural skin is in the denominator.|The null hypothesis is that the odds of belonging to the next higher category of severity are equal in the Daily Emollient and Natural Skin arms, or that the ordinal odds ratio (OR) is equal to 1.||2.21|0.98|0.064
71093683|NCT03409367|141695114|EQUIVALENCE|An ordinal OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD symptoms among those diagnosed with AD.|Odds Ratio (OR)|1.62||||0.007|TWO_SIDED|95.0|1.14|2.3|||Regression, proportional odds|Adjusted for family history of atopy (stratified randomization).|Daily emollient in the numerator and natural skin in the denominator.|The null hypothesis is that the odds of belonging to the next higher category of severity are equal in the Daily Emollient and Natural Skin arms, or that the ordinal odds ratio (OR) is equal to 1.||2.30|1.14|0.007
70918929|NCT02528188|141328705|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.15||0.5785|TWO_SIDED|95.0|-0.21|0.38|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.38|-0.21|0.5785
70918930|NCT02528188|141328707|SUPERIORITY||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.74||0.4303|TWO_SIDED|95.0|-0.87|2.04|||ANCOVA|||Week 16: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.04|-0.87|0.4303
70918931|NCT02528188|141328707|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.75||0.5656|TWO_SIDED|95.0|-1.9|1.04|||ANCOVA|||Week 16: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.04|-1.90|0.5656
70918932|NCT02528188|141328707|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.92||0.976|TWO_SIDED|95.0|-1.78|1.83|||ANCOVA|||Week 24: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.83|-1.78|0.9760
71093684|NCT03409367|141695115|EQUIVALENCE|The ordinal odds ratio (OR) is equal to 1. An OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD symptoms among those diagnosed with AD.|Odds Ratio (OR)|1.45||||0.07|TWO_SIDED|95.0|0.97|2.18|||Regression, proportional odds|Adjusted for family history of atopy (stratified randomization).|Daily moisturizer is the numerator and natural skin is the denominator.|The null hypothesis is that the odds of belonging to the next higher category of severity are equal in the Daily Emollient and Natural Skin arms, or that the ordinal odds ratio (OR) is equal to 1.||2.18|0.97|0.070
71093685|NCT03409367|141695116|EQUIVALENCE|Odds ratio (OR) is equal to 1. An OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD symptoms among those diagnosed with AD.|Odds Ratio (OR)|1.36||||0.085|TWO_SIDED|95.0|0.96|1.91|||Regression, proportional odds|Adjusted for family history of atopy (stratified randomization).||The null hypothesis is that the odds of belonging to the next higher category of severity are equal in the Daily Emollient and Natural Skin arms, or that the odds ratio (OR) is equal to 1. An OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD symptoms among those diagnosed with AD.||1.91|0.96|0.085
71093686|NCT03409367|141695117|EQUIVALENCE|The risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.75||||0.079|TWO_SIDED|95.0|0.55|1.03|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site.||The null hypothesis is that the cumulative incidence of immediate food allergy reactions does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||1.03|0.55|0.079
71093687|NCT03409367|141695118|EQUIVALENCE|Risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.87||||0.669|TWO_SIDED|95.0|0.45|1.66|||Regression, log-binomial|||The null hypothesis is that the cumulative incidence of food allergies does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||1.66|0.45|0.669
71093688|NCT03409367|141695119|EQUIVALENCE|Risk ratio (RR) is equal to 1. Alternatively, a RR \< 1 could be considered evidence that daily emollient is associated with lower incidence of AD.|Risk Ratio (RR)|0.77||||0.013|TWO_SIDED|95.0|0.62|0.95|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site.||The null hypothesis is that the cumulative incidence of AD does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1. Alternatively, a RR \< 1 could be considered evidence that daily emollient is associated with lower incidence of AD.||0.95|0.62|0.013
71093689|NCT03409367|141695120|EQUIVALENCE|Risk ratio (RR) is equal to 1. Alternatively, a RR \< 1 could be considered evidence that daily emollient is associated with lower incidence of AD.|Risk Ratio (RR)|0.8||||0.009|TWO_SIDED|95.0|0.67|0.94|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site.||The null hypothesis is that the cumulative incidence of AD does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1. Alternatively, a RR \< 1 could be considered evidence that daily emollient is associated with lower incidence of AD.||0.94|0.67|0.009
71093690|NCT03409367|141695121|EQUIVALENCE|Risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.77||||0.012|TWO_SIDED|95.0|0.63|0.94|||Regression, log-binomial|Adjusted for primary care site. Adjusted for multiple imputations of 121 missing outcomes.||The null hypothesis is that the cumulative incidence of AD does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||0.94|0.63|0.012
71093691|NCT03409367|141695122|EQUIVALENCE|Risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.9||||0.303|TWO_SIDED|95.0|0.73|1.1|||Regression, log-binomial|Adjusted for primary care site. Adjusted for multiple imputations of 78 missing outcomes.||The null hypothesis is that the cumulative incidence of AD does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||1.10|0.73|0.303
71093692|NCT03459846|141695174|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.789|TWO_SIDED|95.0|0.641|1.387|||Regression, Cox|||||1.387|0.641|0.789
71093693|NCT03459846|141695175|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.728|TWO_SIDED|95.0|0.719|1.606|||Regression, Cox|||||1.606|0.719|0.728
71093694|NCT03459846|141695176|SUPERIORITY||Odds Ratio (OR)|1.76||||0.142|TWO_SIDED|95.0|0.821|3.778|||Regression, Logistic|||||3.778|0.821|0.142
71093695|NCT02141113|141695198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.779|||||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These changed scores show the total change in ADHD symptoms over the course of the trial. Higher values indiicate improved functioning at the end of the trial compared to the beginning.||||.779
71093696|NCT02141113|141695199|SUPERIORITY|||||||0.834|||||||ANOVA|||||||.834
71093697|NCT02141113|141695200|SUPERIORITY_OR_OTHER_LEGACY|||||||0.705|TWO_SIDED||||||ANOVA|||||||.705
71093698|NCT02141113|141695201|SUPERIORITY_OR_OTHER_LEGACY|||||||0.322|TWO_SIDED||||||ANOVA|||||||.322
71093699|NCT02141113|141695202|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043|TWO_SIDED||||||ANOVA|||||||.043
71093700|NCT02141113|141695203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.212|TWO_SIDED||||||ANOVA|||||||.212
71093701|NCT02266576|141695214|OTHER|||||||0.04||||||The linear regression model was used, adjusted for within cohort correlation, within participant correlation, and gender.|Regression, Linear|||Baseline vs month 6||||0.04
71093702|NCT02266576|141695214|OTHER|||||||0.02|||||||Regression, Linear|The linear regression model was used, adjusted for within cohort correlation, within participant correlation, and gender.||Baseline vs month 12||||0.02
71093703|NCT02266576|141695215|OTHER|||||||0.004|||||||Regression, Linear|The linear regression model was used, adjusted for within cohort correlation, within participant correlation, and gender.||Baseline vs month 6 in physical component score||||0.004
71093704|NCT02266576|141695215|OTHER|||||||0.01|||||||Regression, Linear|The linear regression model was used, adjusted for within cohort correlation, within participant correlation, and gender.||Baseline vs month 12 in physical component score||||0.01
71093705|NCT03488524|141695288|SUPERIORITY||Mean Difference (Final Values)|4.23|STANDARD_ERROR_OF_MEAN|1.87||0.0239|TWO_SIDED|95.0|0.56|7.9||Significance testing was 2-tailed and considered statistically significant if the calculated p-value was ≤0.05.|Mixed Models Analysis|Random-slope, shared-baseline, linear mixed model was adjusted for age and prebaseline ALSFRS-R slope.||Participants who did not enter the open-label extension (OLE) were included in this analysis.||7.90|0.56|0.0239
71093706|NCT03488524|141695289|SUPERIORITY||Hazard Ratio (HR)|0.644||||0.0475|TWO_SIDED|95.0|0.416|0.995|||Hazard ratio|||Cox Proportional Hazards analysis||0.995|0.416|0.0475
71093707|NCT03488524|141695290|SUPERIORITY||Hazard Ratio (HR)|0.621||||0.0308|TWO_SIDED|95.0|0.403|0.957|||Hazard Ratio|||||0.957|0.403|0.0308
71093708|NCT03488524|141695291|SUPERIORITY||Mean Difference (Final Values)|7.77|STANDARD_ERROR_OF_MEAN|3.55||0.0291|TWO_SIDED|95.0|0.8|14.75|||Mixed Models Analysis|||||14.75|0.80|0.0291
71093709|NCT03488524|141695292|SUPERIORITY||Mean Difference (Final Values)|4.76|STANDARD_ERROR_OF_MEAN|3.923||0.2261|TWO_SIDED|95.0|-2.95|12.47|||Mixed Models Analysis|||||12.47|-2.95|0.2261
71093710|NCT03488524|141695293|SUPERIORITY||Mean Difference (Final Values)|10.66|STANDARD_ERROR_OF_MEAN|5.103||0.0372|TWO_SIDED|95.0|0.63|20.69||Nominal p-value|Mixed Models Analysis|||||20.69|0.63|0.0372
71154006|NCT06072170|141800223|OTHER|Proportionality analysis was done using a power model.|Slope|0.811|||||TWO_SIDED|90.0|0.637|0.984||||||Statistical Analysis for Dose-Proportionality of Paynantheine Pharmacokinetic Parameters (Pharmacokinetic Population)||0.984|0.637|
70918933|NCT02528188|141328707|SUPERIORITY||LS Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.93||0.5678|TWO_SIDED|95.0|-1.3|2.36|||ANCOVA|||Week 24: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.36|-1.30|0.5678
70971853|NCT01968460|141449964|SUPERIORITY||Mean Difference (Net)|-3.27|STANDARD_ERROR_OF_MEAN|1.24||0.0097|TWO_SIDED|95.0|-5.72|-0.8||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|Mixed Models Analysis|||||-0.80|-5.72|0.0097
70971854|NCT01968460|141449964|SUPERIORITY||Mean Difference (Net)|-2.45|STANDARD_ERROR_OF_MEAN|1.24||0.0509|TWO_SIDED|95.0|-4.91|-0.012||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|Mixed Models Analysis|||||-0.012|-4.91|0.0509
70971855|NCT01780831|141449982|OTHER|Point and 90% CI estimates of percentage Cohort 1 infants who died or had grade 3/4 AE through 6 weeks of life.|Clopper-Pearson Confidence Interval (CI)|25.0|||||TWO_SIDED|90.0|9.0|48.4||||||||48.4|9|
70971856|NCT01780831|141449982|OTHER|Point and 90% CI estimates of percentage Cohort 2 infants who died or had grade 3/4 AE through 6 weeks of life.|Clopper-Pearson Confidence Interval (CI)|31.0|||||TWO_SIDED|90.0|18.7|46.6||||||||46.6|18.7|
70971857|NCT01780831|141449989|OTHER|Point and 90% CI estimates of percentage Cohort 1 infants who died or had grade 3/4 AE through 24 weeks of life.|Clopper-Pearson Confidence Interval (CI)|25.0|||||TWO_SIDED|90.0|9.0|48.4||||||||48.4|9|
70971858|NCT01780831|141449989|OTHER|Point and 90% CI estimates of percentage Cohort 2 infants who died or had grade 3/4 AE through 24 weeks of life.|Clopper-Pearson Confidence Interval (CI)|43.0|||||TWO_SIDED|90.0|28.6|58.1||||||||58.1|28.6|
70971859|NCT01780831|141449990|OTHER|Point and 90% CI estimates of percentage Cohort 1 infants who died or had SADR of Grade 3 or 4 through 6 weeks of life.|Clopper-Pearson Confidence Interval (CI|6.0|||||TWO_SIDED|90.0|0.3|26.4||||||||26.4|0.3|
70971860|NCT01780831|141449990|OTHER|Point and 90% CI estimates of percentage Cohort 2 infants who died or had SADR of Grade 3 or 4 through 6 weeks of life.|Clopper-Pearson Confidence Interval (CI)|0.0|||||TWO_SIDED||||||||CI is not provided since the estimation parameter is 0.|||||
70971861|NCT01780831|141449991|OTHER|Point and 90% CI estimates of percentage Cohort 1 infants who died or had SADR of Grade 3 or 4 through 24 weeks of life.|Clopper-Pearson Confidence Interval (CI)|6.0|||||TWO_SIDED|90.0|0.3|26.4||||||||26.4|0.3|
70971862|NCT01780831|141449991|OTHER|Point and 90% CI estimates of percentage Cohort 2 infants who died or had SADR of Grade 3 or 4 through 24 weeks of life.|Clopper-Pearson Confidence Interval (CI)|0.0|||||TWO_SIDED||||||||CI is not provided since the estimation parameter is 0.|||||
70971863|NCT01780831|141449992|OTHER|||||||0.298|||||||Wilcoxon (Mann-Whitney)|||||||0.298
70971864|NCT01780831|141449993|OTHER|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
70971865|NCT01780831|141449994|OTHER|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||||||0.98
70971866|NCT02264990|141449999|SUPERIORITY|A fixed sequence testing procedure was used for analyses of the primary and secondary efficacy endpoints to control for the familywise error rate. If veliparib plus C/P treatment was not statistically significantly better compared to the investigators' choice of standard therapy for the primary efficacy endpoint of OS in LSP+ participants, then statistical significance would not be declared for any of the secondary efficacy endpoints.|Hazard Ratio (HR)|0.644||||0.113|TWO_SIDED|95.0|0.396|1.048||Statistical significance was determined by a two-sided P value ≤ 0.05.|Log Rank|Log rank test stratified by ECOG performance status, investigators' preferred platinum therapy, and gender.|Hazard ratio obtained using the covariate adjusted Cox Proportional Hazard Model with covariates being ECOG performance status, investigators' preferred platinum therapy, and gender.|||1.048|0.396|0.113
70971867|NCT02264990|141450000|OTHER||Hazard Ratio (HR)|0.647||||0.26|TWO_SIDED|95.0|0.388|1.08|||Log Rank|Log-rank test stratified by investigator's preferred platinum therapy, gender, and ECOG performance status.|The hazard ratio was obtained using the covariate adjusted Cox Proportional Hazard Model with covariates of ECOG performance status, investigators' preferred platinum therapy, and gender.|||1.080|0.388|0.260
70971868|NCT02264990|141450001|OTHER||Odds Ratio (OR)|0.66||||0.455|TWO_SIDED|95.0|0.23|1.9|||Regression, Logistic|Logistic regression adjusted for the covariates of ECOG performance status, investigators' preferred platinum therapy, and gender.|Odds ratio is from covariate adjusted logistic regression with the covariates being ECOG performance status, investigators' preferred platinum therapy, and gender.|||1.90|0.23|0.455
70971869|NCT02264990|141450002|OTHER||Hazard Ratio (HR)|0.986||||0.846|TWO_SIDED|95.0|0.827|1.176|||Log Rank|Log rank test stratified by LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.|The hazard ratio was obtained using the covariate adjusted Cox Proportional Hazard Model with covariates of LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.|||1.176|0.827|0.846
70971870|NCT02264990|141450003|OTHER||Hazard Ratio (HR)|1.035||||0.473|TWO_SIDED|95.0|0.867|1.235|||Log Rank|Log rank test stratified by LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.|The hazard ratio was obtained using the covariate adjusted Cox Proportional Hazard Model with covariates of LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.|||1.235|0.867|0.473
70971871|NCT02264990|141450004|OTHER||Odds Ratio (OR)|0.86||||0.409|TWO_SIDED|95.0|0.59|1.24|||Regression, Logistic|Logistic regression adjusted for the covariates of LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.|Odds ratio is from covariate adjusted logistic regression with the covariates being LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.|||1.24|0.59|0.409
70918934|NCT02528188|141328707|SUPERIORITY||LS Mean Difference|0.68|STANDARD_ERROR_OF_MEAN|1.76||0.6974|TWO_SIDED|95.0|-2.77|4.14|||ANCOVA|||Week 56: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||4.14|-2.77|0.6974
70971872|NCT00267748|141450005|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.089||||0.86|TWO_SIDED|95.0|0.423|2.803|||Log Rank|||For High risk factor, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median TTP was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||2.803|0.423|0.860
70971873|NCT00267748|141450005|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.902||||0.583|TWO_SIDED|95.0|0.623|1.306|||Log Rank|||For intermediate risk factor, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median TTP was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||1.306|0.623|0.583
70971874|NCT00267748|141450005|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.556||||0.075|TWO_SIDED|95.0|0.288|1.074|||Log Rank|||For low risk factor, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median TTP was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||1.074|0.288|0.075
70971875|NCT00267748|141450005|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.827||||0.22|TWO_SIDED|95.0|0.609|1.124|||Log Rank|||For overall stratified analysis, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median TTP was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||1.124|0.609|0.220
70971876|NCT00267748|141450005|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.773||||0.09|TWO_SIDED|95.0|0.572|1.044|||Log Rank|||For overall unstratified analysis, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model. Two-sided unstratified Log rank method was used to calculate p value.||1.044|0.572|0.090
70971877|NCT00267748|141450006|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.11||||0.444|TWO_SIDED|95.0|-6.4|14.6|||Chi-squared|||Response rate was estimated for each treatment group, 95% Confidence Interval (CI) on the difference in response rate between the 2 treatments was computed. P-value was calculated from a Pearson chi-square test.||14.6|-6.4|0.444
70971878|NCT00267748|141450008|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.071||||0.866|TWO_SIDED|95.0|0.481|2.387|||Log Rank|||For high risk factor, the hazard ratio of OS was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median OS was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||2.387|0.481|0.866
70971879|NCT00267748|141450008|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.169||||0.439|TWO_SIDED|95.0|0.785|1.741|||Log Rank|||For intermediate risk factor,the hazard ratio of OS was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median OS was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||1.741|0.785|0.439
70971880|NCT00267748|141450008|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.238||||0.614|TWO_SIDED|95.0|0.538|2.851|||Log Rank|||For low risk factor, the hazard ratio of OS was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median OS was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||2.851|0.538|0.614
70971881|NCT00267748|141450008|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.162||||0.365|TWO_SIDED|95.0|0.838|1.612|||Log Rank|||For overall stratified analysis, the hazard ratio of OS was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median OS was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||1.612|0.838|0.365
70971882|NCT00267748|141450009|SUPERIORITY_OR_OTHER|||||||0.6737|TWO_SIDED||||||t-test, 2 sided|||P value was calculated using sample t-test.||||0.6737
70971883|NCT00267748|141450010|SUPERIORITY_OR_OTHER|||||||0.1967|TWO_SIDED||||||t-test, 2 sided|||P value was calculated using sample t-test.||||0.1967
70971884|NCT01294800|141450011|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.7||||0.0564|TWO_SIDED|95.0|-1.37|0.02|||Constrained longitudinal data analysis|||||0.02|-1.37|0.0564
70971885|NCT01294800|141450011|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.5||||0.1844|TWO_SIDED|95.0|-1.16|0.22|||Constrained longitudinal data analysis|||||0.22|-1.16|0.1844
70971886|NCT01294800|141450011|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.3||||0.3386|TWO_SIDED|95.0|-1.04|0.36|||Constrained longitudinal data analysis|||||0.36|-1.04|0.3386
70971887|NCT01294800|141450012|SUPERIORITY_OR_OTHER||Difference in proportions of responders|5.7||||0.404|TWO_SIDED|95.0|-7.75|19.0|||A generalized linear mixed model|||||19.00|-7.75|0.404
70971888|NCT01294800|141450012|SUPERIORITY_OR_OTHER||Difference in proportions of responders|5.7||||0.39|TWO_SIDED|95.0|-7.73|18.81|||A generalized linear mixed model|||||18.81|-7.73|0.390
70971889|NCT01294800|141450012|SUPERIORITY_OR_OTHER||Difference in proportions of responders|-4.9||||0.508|TWO_SIDED|95.0|-17.78|7.97|||A generalized linear mixed model|||||7.97|-17.78|0.508
70971890|NCT01294800|141450013|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|0.7||||0.0509|TWO_SIDED|95.0|0.0|1.43|||Constrained longitudinal data analysis|||||1.43|-0.00|0.0509
70971891|NCT01294800|141450013|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|0.5||||0.1847|TWO_SIDED|95.0|-0.23|1.19|||Constrained longitudinal data analysis|||||1.19|-0.23|0.1847
70971892|NCT01294800|141450013|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|0.5||||0.2021|TWO_SIDED|95.0|-0.25|1.19|||Constrained longitudinal data analysis|||||1.19|-0.25|0.2021
70971893|NCT01849172|141450016|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
70971894|NCT01857713|141450032|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that the study would be successful if the mean % reduction is significantly greater than 25%. Assuming a 35% reduction in RSI, a power of 80%, one-sided significance level of 0.05, 85 subjects are required for the study. It was decided to recruit up to 100 subjects for this study.|||||<|0.05|||||||t-test, 1 sided|||The sample size was based on the primary effectiveness variable (% reduction in RSI from Baseline to Week 4). It was assumed that the study would be successful if the mean % reduction is significantly greater than 25%. Assuming a 35% reduction in RSI, a power of 80%, one-sided significance level of 0.05, 85 subjects are required for the study. It was decided to recruit up to 100 subjects for this study.||||<0.05
70971895|NCT00797732|141450048|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||.17
71093711|NCT03488524|141695294|SUPERIORITY|||||||0.0503||||||Nominal p-value|Mixed Models Analysis|||||||0.0503
71093712|NCT03279458|141695345|OTHER|least square regression analysis|correlation coefficient (R)|0.94|||<|0.05|TWO_SIDED|95.0|0.88|0.97|||Regression, Linear|||||0.97|0.88|<0.05
71093713|NCT01913353|141695346|NON_INFERIORITY|The non-inferiority margin to show that Group 1 (after 2 doses of MVA-BN) is non-inferior to Group 2 (after 1 dose of ACAM2000) in terms of PRNT GMTs at the respective peak visit (Week 6 in Group 1 / Week 4 in Group 2) was predefined as '1/2 (i.e. 0.5)' for the GMT ratio (Group 1 / Group 2).|GMT Ratio (Group 1 / Group 2)|1.935|||||TWO_SIDED|95.0|1.562|2.397||||||||2.397|1.562|
71093714|NCT01913353|141695347|SUPERIORITY|Predefined threshold of clinical relevance for the area attenuation ratio (AAR): 40%|Area attenuation ratio (AAR)|97.9|||||TWO_SIDED|95.0|96.6|98.3|||||The AAR, i.e. the reduction in MLA \[1 - MLA ratio (Group 1/Group 2)\] after scarification was to be significantly above 40%. The MLA ratio and the corresponding 95% CI were based on the Hodges-Lehmann estimate of the shift for log-transformed MLAs.|||98.3|96.6|
71093715|NCT01147458|141695378|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56|STANDARD_ERROR_OF_MEAN|0.374||0.067|TWO_SIDED|80.0|0.08|1.04|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||1.04|0.08|0.067
71093716|NCT01147458|141695378|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.369||0.701|TWO_SIDED|80.0|-0.67|0.28|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.28|-0.67|0.701
71093717|NCT01147458|141695379|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56|STANDARD_ERROR_OF_MEAN|0.374||0.067|TWO_SIDED|80.0|0.08|1.04|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||1.04|0.08|0.067
71093718|NCT01147458|141695379|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.369||0.701|TWO_SIDED|80.0|-0.67|0.28|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.28|-0.67|0.701
71093719|NCT01147458|141695380|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.172|||TWO_SIDED|80.0|-0.15|0.29|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.29|-0.15|
71093720|NCT01147458|141695380|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|80.0|-0.09|0.35|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.35|-0.09|
71093721|NCT01147458|141695381|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.26|STANDARD_ERROR_OF_MEAN|1.239|||TWO_SIDED|80.0|-0.34|2.85|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||2.85|-0.34|
71093722|NCT01147458|141695381|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|1.252|||TWO_SIDED|80.0|-1.95|1.28|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||1.28|-1.95|
71093723|NCT01147458|141695382|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.06|STANDARD_ERROR_OF_MEAN|1.699|||TWO_SIDED|80.0|-0.13|4.25|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||4.25|-0.13|
71093724|NCT01147458|141695382|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|1.709|||TWO_SIDED|80.0|-2.53|1.88|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||1.88|-2.53|
71093725|NCT01147458|141695383|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77|STANDARD_ERROR_OF_MEAN|0.624|||TWO_SIDED|80.0|-0.03|1.58|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||1.58|-0.03|
71093726|NCT01147458|141695383|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.628|||TWO_SIDED|80.0|-0.97|0.65|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.65|-0.97|
71093727|NCT01147458|141695384|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|80.0|-0.18|0.2|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.20|-0.18|
71093728|NCT01147458|141695384|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.147|||TWO_SIDED|80.0|-0.07|0.31|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.31|-0.07|
71093729|NCT01147458|141695385|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.168|||TWO_SIDED|80.0|-0.12|0.31|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.31|-0.12|
71093730|NCT01147458|141695385|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.162|||TWO_SIDED|80.0|-0.11|0.31|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.31|-0.11|
71093731|NCT02555878|141695392|SUPERIORITY||Hazard Ratio (HR)|0.66|||=|0.101|TWO_SIDED|95.0|0.4|1.09|||Log Rank|||Statistical analysis for primary efficacy composite endpoint.||1.09|0.40|= 0.101
71093732|NCT02555878|141695392|SUPERIORITY||Hazard Ratio (HR)|1.12|||=|0.814|TWO_SIDED|95.0|0.43|2.91|||Log Rank|||Statistical analysis for Symptomatic lower extremity proximal DVT.||2.91|0.43|= 0.814
71154007|NCT06072170|141800223|OTHER|Proportionality analysis was done using a power model.|Slope|0.814|||||TWO_SIDED|90.0|0.633|0.994||||||Statistical Analysis for Dose-Proportionality of Speciogynine Pharmacokinetic Parameters (Pharmacokinetic Population)||0.994|0.633|
70971896|NCT02275338|141450063|OTHER|||||||0.0055||||||The expected proportion of responders using Lanreotide was 50%, 1 sided test, 2.5% significance level alpha and power of 80% using Z-test for binomial proportion.|Binomial test|||One sided binomial test to compare percentage of responding subjects to theoretical proportion of 30%.||||0.0055
70971897|NCT01827670|141450081|SUPERIORITY_OR_OTHER||Adjusted Mean|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.53|-1.06|||ANCOVA|From ANCOVA model: Treatment as fixed factor \& baseline Schiff score as covariate.|Difference was 0.454% stannous fluoride minus 0.76% sodium monofluorophosphate such that a negative difference favours first named treatment.|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments"||-1.06|-1.53|<0.0001
70971898|NCT01827670|141450082|SUPERIORITY_OR_OTHER||Adjusted Mean|-0.81|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.62|||ANCOVA|From ANCOVA model: Treatment as fixed factor \& baseline Schiff score as covariate.|Difference was 0.454% Stannous Fluoride minus 0.76% Sodium MonoFluorophosphate such that a negative difference favored first named treatment|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments"||-0.62|-1.00|<0.0001
70971899|NCT01827670|141450083|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|27.2|||<|0.0001|TWO_SIDED|95.0|19.4|35.1|||ANCOVA|From ANCOVA model: Treatment and baseline Schiff stratification value as fixed factor and baseline tactile threshold as covariate|Difference was 0.454% Stannous Fluoride minus 0.76% Sodium MonoFluorophosphate such that a positive difference favours first named treatment.|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments"||35.1|19.4|<0.0001
70971900|NCT01827670|141450084|SUPERIORITY_OR_OTHER||Adjusted Mean|7.5||||0.0138|TWO_SIDED|95.0|1.6|13.4|||ANCOVA|From ANCOVA model: Treatment and baseline Schiff stratification value as fixed factor and baseline tactile threshold as covariate|Difference was 0.454% Stannous Fluoride minus 0.76% Sodium MonoFluorophosphate such that a positive difference favours first named treatment.|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments"||13.4|1.6|0.0138
70971901|NCT01827670|141450085|SUPERIORITY_OR_OTHER||Adjusted Mean|-12.14||||0.0003|TWO_SIDED|95.0|-18.51|-5.77|||ANCOVA|From ANCOVA model: Treatment and baseline Schiff stratification value as fixed factor and baseline VAS as covariate.|Difference was 0.454% Stannous Fluoride minus 0.76% Sodium MonoFluorophosphate such that a negative difference favored first named treatment|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments"||-5.77|-18.51|0.0003
70971902|NCT01827670|141450086|SUPERIORITY_OR_OTHER||Adjusted Mean|-21.82|||<|0.0001|TWO_SIDED|95.0|-29.55|-14.09|||ANCOVA|From ANCOVA model: Treatment and baseline Schiff stratification value as fixed factor and baseline VAS as covariate.|Difference was 0.454% Stannous Fluoride minus 0.76% Sodium MonoFluorophosphate such that a negative difference favored first named treatment|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments."||-14.09|-29.55|<0.0001
70971903|NCT03603496|141450097|SUPERIORITY||Risk Ratio (RR)|1.18||||0.19|TWO_SIDED|95.0|0.92|1.5|||Chi-squared||Comparing TTCM as numerator, QL as denominator (reference group)|Two-stage multiple imputation techniques were used to estimate the missing smoking outcomes. 1st stage: we imputed missing data from surveys. 2nd stage: we imputed missing data from biochemical sample collection. Null hypothesis was no difference between arms in biochemically-validated past 7-day abstinence from cigarettes and other conventional tobacco products at 6-months. Sample of 1350 (675/group) was planned to detect a 6.5% difference (23.0% vs. 16.5%) with 84% power and 2-sided p\<0.05.||1.50|0.92|.19
70971904|NCT03603496|141450098|SUPERIORITY||Risk Ratio (RR)|1.22||||0.002|TWO_SIDED|95.0|1.08|1.35|||Chi-squared||Numerator is TTCM, denominator (reference group) is QL|Multiple imputation techniques were used to estimate the missing smoking outcomes. The null hypothesis was no difference between study arms.||1.35|1.08|.002
70971905|NCT03603496|141450099|SUPERIORITY||Risk Ratio (RR)|1.23||||0.001|TWO_SIDED|95.0|1.09|1.37|||Chi-squared||Numerator is TTCM, denominator (reference group) is QL|Multiple imputation techniques were used to estimate the missing smoking outcomes. The null hypothesis was no difference between study arms.||1.37|1.09|.001
70971906|NCT03603496|141450100|SUPERIORITY||Risk Ratio (RR)|1.13||||0.079|TWO_SIDED|95.0|0.98|1.29|||Chi-squared||Numerator is TTCM, denominator (reference group) is QL|Multiple imputation techniques were used to estimate the missing smoking outcomes. The null hypothesis was no difference between study arms.||1.29|0.98|.079
70971907|NCT03603496|141450101|SUPERIORITY||Risk Ratio (RR)|1.32|||<|0.0001|TWO_SIDED|95.0|1.21|1.44|||Chi-squared|||Participants lost to follow-up or with missing data are counted as having received no treatment. The null hypothesis was no difference between study arms.||1.44|1.21|<.0001
70971908|NCT03603496|141450102|SUPERIORITY||Risk Ratio (RR)|1.35|||<|0.0001|TWO_SIDED|95.0|1.23|1.5|||Chi-squared|||Participants lost to follow-up or with missing data are counted as having received no treatment. The null hypothesis was no difference between study arms.||1.50|1.23|<.0001
70971909|NCT03603496|141450103|SUPERIORITY||Risk Ratio (RR)|1.31||||0.033|TWO_SIDED|95.0|1.02|1.66|||Chi-squared||Numerator is TTCM, denominator (reference group) is QL|Multiple imputation techniques were used to estimate the missing smoking outcomes. The null hypothesis was no difference between study arms.||1.66|1.02|.033
70971910|NCT00774345|141450104|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.276|TWO_SIDED|95.0|0.61|1.15||The p-value is based on a stratified log-rank test.|Log Rank||Based on the stratified cox proportional hazards model comparing the hazard functions associated with the treatment groups.|||1.15|0.61|0.276
70971911|NCT00684788|141450171|SUPERIORITY||Odds Ratio (OR)|5.68|||=|0.008|TWO_SIDED|95.0|1.61|20.02|||General Estimating Equation (GEE)|||||20.02|1.61|=0.008
70971912|NCT00684788|141450172|SUPERIORITY|||||||0.0033|||||||t-test, 2 sided|||||||0.0033
70971913|NCT00684788|141450175|SUPERIORITY||Odds Ratio (OR)|1.05||||0.939|TWO_SIDED|95.0|0.32|3.42|||General Estimating Equation (GEE)|||||3.42|0.32|0.939
70971914|NCT00684788|141450177|SUPERIORITY||Odds Ratio (OR)|1.074||||0.959|TWO_SIDED|95.0|0.071|16.245|||General Estimating Equation (GEE)|||||16.245|0.071|0.959
70971915|NCT00623428|141450178|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.4557|TWO_SIDED|95.0|0.45|1.43|||Cochran-Mantel-Haenszel|Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).|"The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.~(second column)."|In order to detect an improvement in SVR rate across all strata equivalent to an odds ratio of 2 (i.e. an increase in SVR by 15 to 16 percentage points at a power of 80% and a two-sided significance level of 0.05, 160 patients per treatment group (320 patients in total) were required.||1.43|0.45|0.4557
70971916|NCT00623428|141450179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.0788|TWO_SIDED|95.0|0.33|1.06|||Cochran-Mantel-Haenszel|Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).|The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.|||1.06|0.33|0.0788
71093733|NCT02555878|141695392|SUPERIORITY||Hazard Ratio (HR)|0.4|||=|0.26|TWO_SIDED|95.0|0.08|2.07|||Log Rank|||Statistical analysis for symptomatic lower extremity distal DVT.||2.07|0.08|= 0.260
71093734|NCT02555878|141695392|SUPERIORITY||Hazard Ratio (HR)|0.67|||=|0.538|TWO_SIDED|95.0|0.19|2.39|||Log Rank|||Statistical analysis for symptomatic upper extremity DVT.||2.39|0.19|= 0.538
71154008|NCT06072170|141800223|OTHER|Proportionality analysis was done using a power model.|Slope|0.88|||||TWO_SIDED|90.0|0.72|1.039||||||Statistical Analysis for Dose-Proportionality of Speciociliatine Dose Adjusted Pharmacokinetic Parameters (Pharmacokinetic Population)||1.039|0.720|
70971917|NCT00623428|141450180|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.5654|TWO_SIDED|95.0|0.48|3.87|||Cochran-Mantel-Haenszel|Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).|The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.|||3.87|0.48|0.5654
70971918|NCT00623428|141450182|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||0.1934|TWO_SIDED|95.0|0.38|1.21|||Cochran-Mantel-Haenszel|Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).|The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.|||1.21|0.38|0.1934
70971919|NCT00623428|141450183|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||0.1934|TWO_SIDED|95.0|0.38|1.21|||Cochran-Mantel-Haenszel|Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).|The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.|||1.21|0.38|0.1934
70971920|NCT02342015|141450186|OTHER||||||<|0.05|||||||wilcoxon signed-rank test|||||||<0.05
70971921|NCT02342015|141450187|OTHER||||||<|0.05|||||||paired Student's t-test|||||||<0.05
70971922|NCT01692301|141450189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.66|STANDARD_ERROR_OF_MEAN|1.42||0.01|TWO_SIDED|95.0|-6.45|-0.87|||ANCOVA|||||-0.87|-6.45|0.010
71031849|NCT04239872|141572413|SUPERIORITY||Mean Difference (Net)|-0.00778||||0.8412|TWO_SIDED|95.0|-0.09209|0.07653||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 11 pairs of data, DF=10|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.07653|-0.09209|0.8412
71031850|NCT04239872|141572414|SUPERIORITY||Mean Difference (Net)|-0.06907||||0.6504|TWO_SIDED|95.0|-0.3955|0.2573||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 12 pairs of data, DF=11|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.2573|-0.3955|0.6504
71031851|NCT04239872|141572415|SUPERIORITY||Mean Difference (Net)|0.5307||||0.0024|TWO_SIDED|95.0|0.2372|0.8243||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 11 pairs of data, DF=10|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.8243|0.2372|0.0024
71031852|NCT04239872|141572416|SUPERIORITY||Mean Difference (Net)|0.5643||||0.0013|TWO_SIDED|95.0|0.2938|0.8348||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 9 pairs of data, DF=8|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.8348|0.2938|0.0013
71031853|NCT04239872|141572417|SUPERIORITY||Mean Difference (Net)|-0.1135||||0.2041|TWO_SIDED|95.0|-0.2964|0.06929||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 15 pairs of data, DF=14|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.06929|-0.2964|0.2041
71093735|NCT02555878|141695392|SUPERIORITY||Hazard Ratio (HR)|1.02|||=|0.977|TWO_SIDED|95.0|0.29|3.52|||Log Rank|||Statistical analysis for symptomatic non-fatal PE.||3.52|0.29|= 0.977
71093736|NCT02555878|141695392|SUPERIORITY||Hazard Ratio (HR)|0.35|||=|0.063|TWO_SIDED|95.0|0.11|1.11|||Log Rank|||Statistical analysis for asymptomatic lower extremity proximal DVT.||1.11|0.11|= 0.063
71093737|NCT02555878|141695392|SUPERIORITY||Hazard Ratio (HR)|0.59|||=|0.301|TWO_SIDED|95.0|0.21|1.62|||Log Rank|||Statistical analysis for incidental PE.||1.62|0.21|= 0.301
71093738|NCT02555878|141695392|SUPERIORITY||Hazard Ratio (HR)|0.33|||=|0.314|TWO_SIDED|95.0|0.03|3.18|||Log Rank|||Statistical analysis for VTE-related death.||3.18|0.03|= 0.314
71093739|NCT02555878|141695393|SUPERIORITY||Hazard Ratio (HR)|1.96|||=|0.265|TWO_SIDED|95.0|0.59|6.49|||Log Rank|||||6.49|0.59|= 0.265
71093740|NCT00768053|141695423|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||F test for H0: ICC = 0|F test|||Intraclass correlation coefficient (ICC)||||0.000
71093741|NCT00768053|141695423|SUPERIORITY_OR_OTHER||standard error of measurement|0.65|||||TWO_SIDED|95.0|0.57|0.75||||||Standardized response mean: standard error of measurement||0.75|0.57|
71093742|NCT00768053|141695425|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test for the Pearson correlation|||Week 4||||<0.001
70918935|NCT02528188|141328707|SUPERIORITY||LS Mean Difference|2.64|STANDARD_ERROR_OF_MEAN|1.72||0.1261|TWO_SIDED|95.0|-0.75|6.04|||ANCOVA|||Week 56: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||6.04|-0.75|0.1261
71093743|NCT00768053|141695426|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test for the Pearson correlation|||Week 12||||<0.001
71093744|NCT00768053|141695427|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test for the Pearson correlation|||Time-normalized average||||<0.001
71093745|NCT00768053|141695428|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test for the Pearson correlation|||Week 4||||<0.001
71093746|NCT00768053|141695429|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test for the Pearson correlation|||Week 12||||<0.001
71093747|NCT00768053|141695430|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test for the Pearson correlation|||Time-normalized average||||<0.001
71093748|NCT00768053|141695431|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Pain NRS value||||<0.001
71093749|NCT00768053|141695431|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Functional disability NRS value||||<0.001
71093750|NCT00768053|141695431|SUPERIORITY_OR_OTHER|||||||0.837|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Fatigue NRS value||||0.837
71154009|NCT06072170|141800225|OTHER|Proportionality analysis was done using a power model.|Slope|0.946|||||TWO_SIDED|90.0|0.768|1.123||||||Statistical Analysis for Dose-Proportionality of Mitragynine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.123|0.768|
71154010|NCT06072170|141800225|OTHER|Proportionality analysis was done using a power model.|Slope|0.978|||||TWO_SIDED|90.0|0.821|1.134||||||Statistical Analysis for Dose-Proportionality of 7-Hydroxy-Mitragynine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.134|0.821|
70918936|NCT02528188|141328707|SUPERIORITY||LS Mean Difference|-1.48|STANDARD_ERROR_OF_MEAN|1.78||0.406|TWO_SIDED|95.0|-4.96|2.01|||ANCOVA|||Week 16: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.01|-4.96|0.4060
71093751|NCT00768053|141695431|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Sleep NRS value||||0.035
71093752|NCT00768053|141695431|SUPERIORITY_OR_OTHER|||||||0.351|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Physical well-being NRS value||||0.351
71093753|NCT00768053|141695431|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Emotional well-being NRS value||||0.025
71093754|NCT00768053|141695431|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Coping NRS value||||<0.001
71093755|NCT00768053|141695432|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Pain NRS value||||<0.001
71093756|NCT00768053|141695432|SUPERIORITY_OR_OTHER|||||||0.052|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Functional disability NRS value||||0.052
71093757|NCT00768053|141695432|SUPERIORITY_OR_OTHER|||||||0.895|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Fatigue NRS value||||0.895
71093758|NCT00768053|141695432|SUPERIORITY_OR_OTHER|||||||0.153|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Sleep NRS value||||0.153
71093759|NCT00768053|141695432|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Physical well-being NRS value||||0.029
71093760|NCT00768053|141695432|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Emotional well-being NRS value||||0.043
71093761|NCT00768053|141695432|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Coping NRS value||||<0.001
71093762|NCT01164475|141695449|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.395|TWO_SIDED|95.0|0.44|9.17|||Regression, Logistic|||The comparison was done using the logistic regression model, adjusted for country and baseline PB CD34+ cell count.||9.17|0.44|0.395
71093763|NCT04603066|141695462|SUPERIORITY||Mean Difference (Final Values)|0.0204257||||0.8651|TWO_SIDED|95.0|-0.2624635|0.2216122|||t-test, 2 sided|||||0.2216122|-0.2624635|0.8651
71093764|NCT04603066|141695463|SUPERIORITY||Mean Difference (Net)|0.01727052||||0.056|TWO_SIDED|95.0|-0.0005895|0.03513063|||t-test, 2 sided|||||0.03513063|-0.0005895|0.056
71093765|NCT04937387|141695468|OTHER||Least Squares Mean Difference|0.059|STANDARD_ERROR_OF_MEAN|0.0449|||TWO_SIDED|95.0|-0.03|0.147|||||||Analysis performed using mixed effect model for repeated measures with covariates of treatment, age, sex, eCRF-reported pre-study ICS dosage at screening (med, high), baseline trough FEV1 value, visit, and interaction terms for baseline trough FEV1-by-visit and treatment-by-visit, covariance structure = unstructured.|0.147|-0.030|
71093766|NCT04937387|141695468|OTHER||Posterior Mean|0.076|||||TWO_SIDED|90.0|0.025|0.115|||||Analysis was conducted in the Bayesian paradigm using the pre-specified mixture prior distribution, which was updated with the treatment difference between FF/UMEC/VI 100/62.5/25 and FF/VI 100/25 estimated in the MMRM analysis.|||0.115|0.025|
71093767|NCT04937387|141695468|OTHER||Posterior Median|0.079|||||TWO_SIDED|95.0|0.005|0.123|||||Analysis was conducted in the Bayesian paradigm using the pre-specified mixture prior distribution, which was updated with the treatment difference between FF/UMEC/VI 100/62.5/25 and FF/VI 100/25 estimated in the MMRM analysis.|||0.123|0.005|
71093768|NCT04937387|141695469|OTHER||Least Squares Mean Difference|-0.005|STANDARD_ERROR_OF_MEAN|0.0455|||TWO_SIDED|95.0|-0.094|0.084|||||||Analysis performed using mixed effect model for repeated measures with covariates of treatment, age, sex, eCRF-reported pre-study ICS dosage at screening (med, high), baseline trough FEV1 value, visit, and interaction terms for baseline trough FEV1-by-visit and treatment-by-visit, covariance structure = unstructured.|0.084|-0.094|
71093769|NCT04937387|141695469|OTHER||Posterior Mean|0.023|||||TWO_SIDED|90.0|-0.071|0.103|||||Analysis was conducted in the Bayesian paradigm using the pre-specified mixture prior distribution, which was updated with the treatment difference between FF/UMEC/VI 200/62.5/25 and FF/VI 200/25 estimated in the MMRM analysis.|||0.103|-0.071|
71093770|NCT04937387|141695469|OTHER||Posterior Median|0.023||||||95.0|-0.086|0.11|||||Analysis was conducted in the Bayesian paradigm using the pre-specified mixture prior distribution, which was updated with the treatment difference between FF/UMEC/VI 200/62.5/25 and FF/VI 200/25 estimated in the MMRM analysis.|||0.110|-0.086|
71154011|NCT06072170|141800225|OTHER|Proportionality analysis was done using a power model.|Slope|1.075|||||TWO_SIDED|90.0|0.901|1.249||||||Statistical Analysis for Dose-Proportionality of Paynantheine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.249|0.901|
70971923|NCT02109484|141450205|EQUIVALENCE|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.||||||0.0165|||||||Wilcoxon (Mann-Whitney)|||||||0.0165
70971924|NCT02109484|141450205|EQUIVALENCE|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.||||<0.0001
70971925|NCT02109484|141450205|EQUIVALENCE|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
70971926|NCT02109484|141450206|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Pair-wise comparisons between Cohort B Placebo group and the active vaccination groups were peformed||||<0.0001
70971927|NCT02109484|141450206|EQUIVALENCE|Pair-wise comparisons between Cohort B Placebo group and the active vaccination groups were performed|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71093771|NCT04937387|141695470|OTHER||Least Squares Mean Difference|-0.028|STANDARD_ERROR_OF_MEAN|0.0823|||TWO_SIDED|95.0|-0.19|0.134|||||||Analysis performed using mixed effect model for repeated measures with covariates of treatment, age, sex, eCRF-reported pre-study ICS dosage at screening (med, high), baseline ACQ-7 total score, visit, and interaction terms for baseline ACQ-7 total score-by-visit and treatment-by-visit, covariance structure = unstructured.|0.134|-0.190|
71093772|NCT04937387|141695470|OTHER||Least Squares Mean Difference|0.112|STANDARD_ERROR_OF_MEAN|0.0832|||TWO_SIDED|95.0|-0.052|0.276|||||||Analysis performed using mixed effect model for repeated measures with covariates of treatment, age, sex, eCRF-reported pre-study ICS dosage at screening (med, high), baseline ACQ-7 total score, visit, and interaction terms for baseline ACQ-7 total score-by-visit and treatment-by-visit, covariance structure = unstructured.|0.276|-0.052|
71093773|NCT03244189|141695523|OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.77|1.2||||||||1.20|0.77|
71093774|NCT03244189|141695524|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.72|1.37||||||||1.37|0.72|
71093775|NCT03244189|141695525|OTHER||Odds Ratio (OR)|1.44|||||TWO_SIDED|95.0|0.91|2.29||||||||2.29|0.91|
71093776|NCT00884065|141695584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|4.08|>|0.05|TWO_SIDED|95.0|-9.93|6.49|||t-test, 2 sided|||||6.49|-9.93|>0.05
71093777|NCT00884065|141695585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.4|STANDARD_ERROR_OF_MEAN|2.83|<|0.01||95.0|5.72|17.08|||t-test, 2 sided|||||17.08|5.72|<0.01
71093778|NCT00884065|141695586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.24|STANDARD_ERROR_OF_MEAN|2.59|<|0.01|TWO_SIDED|95.0|2.03|12.45|||t-test, 2 sided|||||12.45|2.03|<0.01
71093779|NCT00884065|141695587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.92|STANDARD_ERROR_OF_MEAN|1.72|>|0.05|TWO_SIDED|95.0|-1.53|5.37|||t-test, 2 sided|||||5.37|-1.53|>0.05
71093780|NCT00884065|141695588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|2.18|>|0.05|TWO_SIDED|95.0|-3.81|5.01|||t-test, 2 sided|||||5.01|-3.81|>0.05
70918937|NCT02528188|141328707|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|1.78||0.848|TWO_SIDED|95.0|-3.84|3.15|||ANCOVA|||Week 16: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.15|-3.84|0.8480
71154012|NCT06072170|141800225|OTHER|Proportionality analysis was done using a power model.|Slope|1.046|||||TWO_SIDED|90.0|0.87|1.222||||||Statistical Analysis for Dose-Proportionality of Speciogynine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.222|0.870|
70971928|NCT02109484|141450206|EQUIVALENCE|Pair-wise comparisons between Cohort B Placebo group and the active vaccination groups were performed||||||0.0006|||||||Wilcoxon (Mann-Whitney)|||||||0.0006
70971929|NCT02109484|141450207|EQUIVALENCE|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.||||||0.0004|||||||Wilcoxon (Mann-Whitney)|||A pair wise comparison between the Adjusted Seroresponses in the placebo group and the Group B 10 mcg P2-VP8 was performed.||||0.0004
70971930|NCT02109484|141450207|EQUIVALENCE|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||A pair wise comparison between the Adjusted Seroresponses in the placebo group and the Cohort B 30 mcg P2-VP8 vaccine group was performed.||||<0.0001
70971931|NCT02109484|141450207|EQUIVALENCE|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||A pair-wise comparison between the Adjusted Seroresponses in Cohort B Placebo group and the Cohort B P2-VP8 group was performed.||||<0.0001
70971932|NCT02171611|141450217|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|175.14|STANDARD_ERROR_OF_MEAN|50.7|||TWO_SIDED|90.0|141.904|216.149|||||Relative bioavailability was estimated by the ratio of the gMeans of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual coefficient variation (gCV).|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||216.149|141.904|
70971933|NCT02171611|141450217|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|154.84|STANDARD_ERROR_OF_MEAN|46.6|||TWO_SIDED|90.0|127.425|188.161|||||Relative bioavailability was estimated by the ratio of the geometric means (gMeans) of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment (T2) vs. the Reference treatment (R). This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||188.161|127.425|
70971934|NCT02171611|141450218|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|175.4|STANDARD_ERROR_OF_MEAN|51.1|||TWO_SIDED|90.0|141.924|216.772|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||216.772|141.924|
70971935|NCT02171611|141450218|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|158.12|STANDARD_ERROR_OF_MEAN|46.7|||TWO_SIDED|90.0|130.052|192.255|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||192.255|130.052|
70971936|NCT02171611|141450219|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|186.94|STANDARD_ERROR_OF_MEAN|57.7|||TWO_SIDED|90.0|147.659|236.665|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||236.665|147.659|
71008721|NCT02055976|141525246|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.07|STANDARD_ERROR_OF_MEAN|1.915||0.056|TWO_SIDED|95.0|-6.876|0.736|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||0.736|-6.876|0.056
71093781|NCT00884065|141695589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.08|STANDARD_ERROR_OF_MEAN|1.49|<|0.01|TWO_SIDED|95.0|0.08|6.09|||t-test, 2 sided|||||6.09|0.08|<0.01
71093782|NCT04615507|141695609|SUPERIORITY|The superiority of the Test lens will be concluded if the upper confidence limit of the mean is below the predefined threshold +0.00 logMAR for Distance.|Mean estimate|-0.132|STANDARD_ERROR_OF_MEAN|0.0201|||TWO_SIDED|95.0|-0.18|-0.083|||Linear Mixed Model|Kenward and Roger Method was used for denominator degrees of freedom.||||-0.083|-0.180|
71093783|NCT04615507|141695609|SUPERIORITY|The superiority of the Test lens will be concluded if the upper confidence limit of the mean is below the predefined threshold +0.17 logMAR for Intermediate.|Mean estimate|-0.066|STANDARD_ERROR_OF_MEAN|0.0202|||TWO_SIDED|95.0|-0.115|-0.017|||Linear Mixed Model|Kenward and Roger Method was used for denominator degrees of freedom.||||-0.017|-0.115|
71093784|NCT04615507|141695609|SUPERIORITY|The superiority of the Test lens will be concluded if the upper confidence limit of the mean is below the predefined threshold +0.17 logMAR for Near.|Mean estimate|0.072|STANDARD_ERROR_OF_MEAN|0.0217|||TWO_SIDED|95.0|0.022|0.121|||Linear Mixed Model|Kenward and Roger Method was used for denominator degrees of freedom.||||0.121|0.022|
71093785|NCT04615507|141695610|SUPERIORITY|The superiority of the Test lens will be concluded if the lower confidence limit of the LSM is above the predefined threshold 32 points.|Least-square mean|59.6|STANDARD_ERROR_OF_MEAN|3.05|||TWO_SIDED|95.0|52.3|66.8|||Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom||||66.8|52.3|
71093786|NCT04615507|141695610|NON_INFERIORITY|The non-Inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above -5 points.|Least-square mean difference|5.5|STANDARD_ERROR_OF_MEAN|2.36|||TWO_SIDED|95.0|0.9|10.2|||Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom|LSM difference was calculated as Test minus Control|||10.2|0.9|
71093787|NCT04950686|141695611|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.002|STANDARD_ERROR_OF_MEAN|0.08||0.983|TWO_SIDED||||||Mixed Models Analysis|||||||0.983
71093788|NCT04950686|141695611|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.09||0.465|TWO_SIDED||||||Mixed Models Analysis|||||||0.465
71093789|NCT04950686|141695612|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.09||0.579|TWO_SIDED||||||Mixed Models Analysis|||||||0.579
70918938|NCT02528188|141328707|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|1.94||0.923|TWO_SIDED|95.0|-4.0|3.63|||ANCOVA|||Week 24: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.63|-4.00|0.9230
71093790|NCT04950686|141695612|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Median Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.12||0.536|TWO_SIDED||||||Mixed Models Analysis|||||||0.536
71093791|NCT04950686|141695613|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.11||0.745|TWO_SIDED||||||Mixed Models Analysis|||||||0.745
70918939|NCT02528188|141328707|SUPERIORITY||LS Mean Difference|-1.51|STANDARD_ERROR_OF_MEAN|1.96||0.4421|TWO_SIDED|95.0|-5.36|2.34|||ANCOVA|||Week 24: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.34|-5.36|0.4421
71093792|NCT04950686|141695613|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.005|STANDARD_ERROR_OF_MEAN|0.14||0.972|TWO_SIDED||||||Mixed Models Analysis|||||||0.972
71093793|NCT04950686|141695614|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.12||||0.682|TWO_SIDED|95.0|0.24|5.25|||Mixed Models Analysis|||||5.25|0.24|0.682
71093794|NCT04950686|141695614|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.15||||0.63|TWO_SIDED|95.0|0.28|4.69|||Mixed Models Analysis|||||4.69|0.28|0.630
71093795|NCT04950686|141695615|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.26||||0.418|TWO_SIDED|95.0|0.12|12.82|||Mixed Models Analysis|||||12.82|0.12|0.418
71093796|NCT04950686|141695615|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.47||||0.194|TWO_SIDED|95.0|0.13|17.29|||Mixed Models Analysis|||||17.29|0.13|0.194
71093797|NCT04950686|141695616|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.91||||0.731|TWO_SIDED|95.0|0.1|8.07|||Mixed Models Analysis|||||8.07|0.10|0.731
71093798|NCT04950686|141695616|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.08||||0.786|TWO_SIDED|95.0|0.16|7.34|||Mixed Models Analysis|||||7.34|0.16|0.786
71093799|NCT04950686|141695617|SUPERIORITY|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.11||||0.71|TWO_SIDED|95.0|0.16|7.49|||Mixed Models Analysis|||||7.49|0.16|0.710
71093800|NCT04950686|141695617|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.16||||0.61|TWO_SIDED|95.0|0.16|8.73|||Mixed Models Analysis|||||8.73|0.16|0.610
71093801|NCT04950686|141695618|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.37||||0.27|TWO_SIDED|95.0|0.09|20.33|||Mixed Models Analysis|||||20.33|.09|0.270
71093802|NCT04950686|141695618|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.25||||0.465|TWO_SIDED|95.0|0.08|18.57|||Mixed Models Analysis|||||18.57|0.08|0.465
71093803|NCT04950686|141695619|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.91||||0.702|TWO_SIDED|95.0|0.07|11.95|||Mixed Models Analysis|||||11.95|0.07|0.702
71093804|NCT04950686|141695619|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.21||||0.538|TWO_SIDED|95.0|0.19|7.56|||Mixed Models Analysis|||||7.56|0.19|0.538
71093805|NCT04950686|141695620|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.04||0.084|TWO_SIDED||||||Mixed Models Analysis|||||||0.084
71093806|NCT04950686|141695620|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.04||0.501|TWO_SIDED||||||Mixed Models Analysis|||||||0.501
71154013|NCT06072170|141800225|OTHER|Proportionality analysis was done using a power model.|Slope|1.011|||||TWO_SIDED|90.0|0.844|1.178||||||Statistical Analysis for Dose-Proportionality of Speciociliatine Dose Adjusted Pharmacokinetic Parameters (Pharmacokinetic Population)||1.178|0.844|
70971937|NCT02171611|141450219|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|166.59|STANDARD_ERROR_OF_MEAN|54.3|||TWO_SIDED|90.0|133.221|208.326|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||208.326|133.221|
71008722|NCT02055976|141525246|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.557|STANDARD_ERROR_OF_MEAN|1.937||0.095|TWO_SIDED|95.0|-6.408|1.293|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.293|-6.408|0.095
71093807|NCT04950686|141695621|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.03||0.614|TWO_SIDED||||||Mixed Models Analysis|||||||0.614
71093808|NCT04950686|141695621|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.854|TWO_SIDED||||||Mixed Models Analysis|||||||0.854
71093809|NCT04950686|141695622|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.03||0.499|TWO_SIDED||||||Mixed Models Analysis|||||||0.499
71093810|NCT04950686|141695622|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.04||0.623|TWO_SIDED||||||Mixed Models Analysis|||||||0.623
71093811|NCT04950686|141695623|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.84||||0.618|TWO_SIDED|95.0|0.14|5.15|||Mixed Models Analysis|||||5.15|0.14|0.618
71093812|NCT04950686|141695623|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.19||||0.626|TWO_SIDED|95.0|0.1|14.13|||Mixed Models Analysis|||||14.13|0.10|0.626
71093813|NCT04950686|141695624|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.47||||0.232|TWO_SIDED|95.0|0.23|9.18|||Mixed Models Analysis|||||9.18|0.23|.232
71093814|NCT04950686|141695624|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.08||||0.811|TWO_SIDED|95.0|0.22|5.38|||Mixed Models Analysis|||||5.38|0.22|0.811
71093815|NCT04950686|141695625|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.26||||0.427|TWO_SIDED|95.0|0.16|9.94|||Mixed Models Analysis|||||9.94|0.16|0.427
71093816|NCT04950686|141695625|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.39||||0.337|TWO_SIDED|95.0|0.25|7.68|||Mixed Models Analysis|||||7.68|0.25|0.337
71093817|NCT04950686|141695626|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.11||0.419|TWO_SIDED||||||Mixed Models Analysis|||||||0.419
71093818|NCT04950686|141695626|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.12||0.808|TWO_SIDED||||||Mixed Models Analysis|||||||0.808
71093819|NCT04950686|141695627|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.12||0.616|TWO_SIDED||||||Mixed Models Analysis|||||||0.616
71093820|NCT04950686|141695627|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.12||0.486|TWO_SIDED||||||Mixed Models Analysis|||||||0.486
71093821|NCT04950686|141695628|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.12||0.638|TWO_SIDED||||||Mixed Models Analysis|||||||0.638
71093822|NCT04950686|141695628|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.226|TWO_SIDED||||||Mixed Models Analysis|||||||0.226
71093823|NCT04950686|141695629|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.14||0.63|TWO_SIDED||||||Mixed Models Analysis|||||||0.630
71093824|NCT04950686|141695629|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.15||0.88|TWO_SIDED||||||Mixed Models Analysis|||||||0.880
71093825|NCT04950686|141695630|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.11||0.569|TWO_SIDED||||||Mixed Models Analysis|||||||0.569
71093826|NCT04950686|141695630|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.003|STANDARD_ERROR_OF_MEAN|0.12||0.98|TWO_SIDED||||||Mixed Models Analysis|||||||0.980
71093827|NCT04950686|141695631|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.466|TWO_SIDED||||||Mixed Models Analysis|||||||0.466
71093828|NCT04950686|141695631|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.13||0.99|TWO_SIDED||||||Mixed Models Analysis|||||||0.990
71154014|NCT06072170|141800226|OTHER|Proportionality analysis was done using a power model.|Slope|0.959|||||TWO_SIDED|90.0|0.775|1.143||||||Statistical Analysis for Dose-Proportionality of Mitragynine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.143|0.775|
71093829|NCT04950686|141695632|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.002|STANDARD_ERROR_OF_MEAN|0.14||0.989|TWO_SIDED||||||Mixed Models Analysis|||||||0.989
71093830|NCT04950686|141695632|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.16||0.678|TWO_SIDED||||||Mixed Models Analysis|||||||0.678
71093831|NCT04950686|141695633|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.14||0.075|TWO_SIDED||||||Mixed Models Analysis|||||||0.075
71093832|NCT04950686|141695633|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.35|STANDARD_ERROR_OF_MEAN|0.15||0.024|TWO_SIDED||||||Mixed Models Analysis|||||||0.024
71093833|NCT04950686|141695634|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.16||0.301|TWO_SIDED||||||Mixed Models Analysis|||||||0.301
71093834|NCT04950686|141695634|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.17||0.702|TWO_SIDED||||||Mixed Models Analysis|||||||0.702
71093835|NCT04950686|141695635|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.76||||0.352|TWO_SIDED|95.0|0.1|6.13|||Mixed Models Analysis|||||6.13|0.10|0.352
70971938|NCT02171611|141450220|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|181.6|STANDARD_ERROR_OF_MEAN|53.9|||TWO_SIDED|90.0|145.428|226.776|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||226.776|145.428|
71093836|NCT04950686|141695635|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.82||||0.445|TWO_SIDED|95.0|0.11|6.16|||Mixed Models Analysis|||||6.16|0.11|0.445
71093837|NCT04950686|141695636|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.55||||0.039|TWO_SIDED|95.0|0.12|2.6|||Mixed Models Analysis|||||2.60|0.12|0.039
71031854|NCT04239872|141572418|SUPERIORITY||Mean Difference (Net)|1.095|||<|0.0001|TWO_SIDED|95.0|0.7736|1.416||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 13 pairs of data, DF=12|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.416|0.7736|<0.0001
71031855|NCT04239872|141572419|SUPERIORITY||Mean Difference (Net)|1.469|||<|0.0001|TWO_SIDED|95.0|1.112|1.825||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 13 pairs of data, DF=12|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.825|1.112|<0.0001
71093838|NCT04950686|141695636|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.59||||0.073|TWO_SIDED|95.0|0.17|2.12|||Mixed Models Analysis|||||2.12|0.17|0.073
71093839|NCT04950686|141695637|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.62||||0.11|TWO_SIDED|95.0|0.13|2.93|||Mixed Models Analysis|||||2.93|0.13|0.110
71093840|NCT04950686|141695637|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.65||||0.174|TWO_SIDED|95.0|0.11|3.78|||Mixed Models Analysis|||||3.78|0.11|0.174
71093841|NCT04950686|141695638|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.39|STANDARD_ERROR_OF_MEAN|0.31||0.208|TWO_SIDED||||||Mixed Models Analysis|||||||0.208
71008723|NCT02055976|141525246|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.271|STANDARD_ERROR_OF_MEAN|1.913||0.004|TWO_SIDED|95.0|-9.074|-1.469|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.469|-9.074|0.004
71093842|NCT04950686|141695638|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.37|STANDARD_ERROR_OF_MEAN|0.35||0.302|TWO_SIDED||||||Mixed Models Analysis|||||||0.302
71093843|NCT04950686|141695639|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.35||0.483|TWO_SIDED||||||Mixed Models Analysis|||||||0.483
71093844|NCT04950686|141695639|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.3||0.933|TWO_SIDED||||||Mixed Models Analysis|||||||0.933
71093845|NCT04950686|141695640|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.32||0.877|TWO_SIDED||||||Mixed Models Analysis|||||||0.877
71093846|NCT04950686|141695640|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.32||0.418|TWO_SIDED||||||Mixed Models Analysis|||||||0.418
71093847|NCT04950686|141695641|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|2.23||||0.22|TWO_SIDED|95.0|0.05|98.76|||Mixed Models Analysis|||||98.76|0.05|0.220
71093848|NCT04950686|141695641|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.1|11.3||||||||11.30|0.10|
71093849|NCT04950686|141695642|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.48||||0.506|TWO_SIDED|95.0|0.03|63.29|||Mixed Models Analysis|||||63.29|0.03|0.506
71093850|NCT04950686|141695642|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.04|36.32||||||||36.32|0.04|
71093851|NCT04950686|141695643|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.09||||0.877|TWO_SIDED|95.0|0.04|28.37|||Mixed Models Analysis|||||28.37|0.04|0.877
71093852|NCT04950686|141695643|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.02|26.92||||||||26.92|0.02|
71093853|NCT04950686|141695644|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.04||0.005|TWO_SIDED||||||Mixed Models Analysis|||||||0.005
71093854|NCT04950686|141695644|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.05||1e-05|TWO_SIDED||||||Mixed Models Analysis|||||||0.00001
71093855|NCT04950686|141695645|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.314|TWO_SIDED||||||Mixed Models Analysis|||||||0.314
71093856|NCT04950686|141695645|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.06||0.176|TWO_SIDED||||||Mixed Models Analysis|||||||0.176
71093857|NCT04950686|141695646|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.05||0.009|TWO_SIDED||||||Mixed Models Analysis|||||||0.009
71154015|NCT06072170|141800226|OTHER|Proportionality analysis was done using a power model.|Slope|0.974|||||TWO_SIDED|90.0|0.815|1.134||||||Statistical Analysis for Dose-Proportionality of 7-Hydroxy-Mitragynine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.134|0.815|
71093858|NCT04950686|141695646|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.008|TWO_SIDED||||||Mixed Models Analysis|||||||0.008
71093859|NCT04950686|141695647|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.132|TWO_SIDED||||||Mixed Models Analysis|||||||0.132
71093860|NCT04950686|141695647|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.04||0.008|TWO_SIDED||||||Mixed Models Analysis|||||||0.008
71093861|NCT04950686|141695648|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.003|STANDARD_ERROR_OF_MEAN|0.05||0.941|TWO_SIDED||||||Mixed Models Analysis|||||||0.941
71093862|NCT04950686|141695648|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.05||0.569|TWO_SIDED||||||Mixed Models Analysis|||||||0.569
71093863|NCT04950686|141695649|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.04||0.354|TWO_SIDED||||||Mixed Models Analysis|||||||0.354
71093864|NCT04950686|141695649|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.05||0.038|TWO_SIDED||||||Mixed Models Analysis|||||||0.038
71093865|NCT04950686|141695650|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.05||0.501|TWO_SIDED||||||Mixed Models Analysis|||||||0.501
71093866|NCT04950686|141695650|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.06||0.385|TWO_SIDED||||||Mixed Models Analysis|||||||0.385
71093867|NCT04950686|141695651|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.095|TWO_SIDED||||||Mixed Models Analysis|||||||0.095
70918940|NCT02528188|141328707|SUPERIORITY||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|2.44||0.2049|TWO_SIDED|95.0|-1.7|7.91|||ANCOVA|||Week 56: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||7.91|-1.70|0.2049
71093868|NCT04950686|141695651|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.349|TWO_SIDED||||||Mixed Models Analysis|||||||0.349
71093869|NCT04950686|141695652|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.846|TWO_SIDED||||||Mixed Models Analysis|||||||0.846
71093870|NCT04950686|141695652|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.103|TWO_SIDED||||||Mixed Models Analysis|||||||0.103
71093871|NCT04950686|141695653|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.864|TWO_SIDED||||||Mixed Models Analysis|||||||0.864
71093872|NCT04950686|141695653|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.06||0.054|TWO_SIDED||||||Mixed Models Analysis|||||||0.054
70918941|NCT02528188|141328707|SUPERIORITY||LS Mean Difference|4.68|STANDARD_ERROR_OF_MEAN|2.4||0.0527|TWO_SIDED|95.0|-0.05|9.41|||ANCOVA|||Week 56: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||9.41|-0.05|0.0527
71093873|NCT04950686|141695654|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.05||0.168|TWO_SIDED||||||Mixed Models Analysis|||||||0.168
71093874|NCT04950686|141695654|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.06||0.063|TWO_SIDED||||||Mixed Models Analysis|||||||0.063
71093875|NCT04950686|141695655|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.819|TWO_SIDED||||||Mixed Models Analysis|||||||0.819
71093876|NCT04950686|141695655|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.06||0.775|TWO_SIDED||||||Mixed Models Analysis|||||||0.775
71093877|NCT04950686|141695656|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.034|TWO_SIDED||||||Mixed Models Analysis|||||||0.034
71093878|NCT04950686|141695656|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.579|TWO_SIDED||||||Mixed Models Analysis|||||||0.579
71093879|NCT04950686|141695657|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.04||0.485|TWO_SIDED||||||Mixed Models Analysis|||||||0.485
71093880|NCT04950686|141695657|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.911|TWO_SIDED||||||Mixed Models Analysis|||||||0.911
71093881|NCT04950686|141695658|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.04||0.583|TWO_SIDED||||||Mixed Models Analysis|||||||0.583
71093882|NCT04950686|141695658|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.04||0.971|TWO_SIDED||||||Mixed Models Analysis|||||||0.971
71093883|NCT04950686|141695659|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.04||0.602|TWO_SIDED||||||Mixed Models Analysis|||||||0.602
71093884|NCT04950686|141695659|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.003|STANDARD_ERROR_OF_MEAN|0.04||0.948|TWO_SIDED||||||Mixed Models Analysis|||||||0.948
71093885|NCT04950686|141695660|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.763|TWO_SIDED||||||Mixed Models Analysis|||||||0.763
71093886|NCT04950686|141695660|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.04||0.578|TWO_SIDED||||||Mixed Models Analysis|||||||0.578
71093887|NCT04950686|141695661|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.863|TWO_SIDED||||||Mixed Models Analysis|||||||0.863
71093888|NCT04950686|141695661|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.04||0.538|TWO_SIDED||||||Mixed Models Analysis|||||||0.538
71093889|NCT04950686|141695662|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.62|STANDARD_ERROR_OF_MEAN|1.41||0.662|TWO_SIDED||||||Mixed Models Analysis|||||||0.662
71154016|NCT06072170|141800226|OTHER|Proportionality analysis was done using a power model.|Slope|1.036|||||TWO_SIDED|90.0|0.866|1.207||||||Statistical Analysis for Dose-Proportionality of Paynantheine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.207|0.866|
70918942|NCT02528188|141328707|SUPERIORITY||LS Mean Difference|-1.63|STANDARD_ERROR_OF_MEAN|1.82||0.3699|TWO_SIDED|95.0|-5.21|1.94|||ANCOVA|||Week 16: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.94|-5.21|0.3699
70918943|NCT02528188|141328707|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|1.83||0.7945|TWO_SIDED|95.0|-4.06|3.11|||ANCOVA|||Week 16: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.11|-4.06|0.7945
70918944|NCT02528188|141328707|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|2.03||0.941|TWO_SIDED|95.0|-4.13|3.83|||ANCOVA|||Week 24: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.83|-4.13|0.9410
70918945|NCT02528188|141328707|SUPERIORITY||LS Mean Difference|-1.43|STANDARD_ERROR_OF_MEAN|2.05||0.486|TWO_SIDED|95.0|-5.44|2.59|||ANCOVA|||Week 24: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.59|-5.44|0.4860
70918946|NCT02528188|141328707|SUPERIORITY||LS Mean Difference|3.05|STANDARD_ERROR_OF_MEAN|2.62||0.2448|TWO_SIDED|95.0|-2.1|8.2|||ANCOVA|||Week 56: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||8.20|-2.10|0.2448
70918947|NCT02528188|141328707|SUPERIORITY||LS Mean Difference|4.96|STANDARD_ERROR_OF_MEAN|2.58||0.0551|TWO_SIDED|95.0|-0.11|10.04|||ANCOVA|||Week 56: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||10.04|-0.11|0.0551
70918948|NCT02528188|141328707|SUPERIORITY||LS Mean Difference|-1.21|STANDARD_ERROR_OF_MEAN|1.05||0.247|TWO_SIDED|95.0|-3.26|0.84|||ANCOVA|||Week 16: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||0.84|-3.26|0.2470
70918949|NCT02528188|141328707|SUPERIORITY||LS Mean Difference|-1.98|STANDARD_ERROR_OF_MEAN|1.04||0.057|TWO_SIDED|95.0|-4.01|0.06|||ANCOVA|||Week 16: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||0.06|-4.01|0.0570
70918950|NCT02528188|141328707|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|1.14||0.917|TWO_SIDED|95.0|-2.36|2.12|||ANCOVA|||Week 24: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.12|-2.36|0.9170
71093890|NCT04950686|141695662|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-1.51|STANDARD_ERROR_OF_MEAN|1.81||0.406|TWO_SIDED||||||Mixed Models Analysis|||||||0.406
71093891|NCT04950686|141695663|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-2.66|STANDARD_ERROR_OF_MEAN|1.64||0.105|TWO_SIDED||||||Mixed Models Analysis|||||||0.105
71093892|NCT04950686|141695663|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-1.33|STANDARD_ERROR_OF_MEAN|1.91||0.487|TWO_SIDED||||||Mixed Models Analysis|||||||0.487
71093893|NCT04950686|141695664|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-2.3|STANDARD_ERROR_OF_MEAN|1.68||0.171|TWO_SIDED||||||Mixed Models Analysis|||||||0.171
71093894|NCT04950686|141695664|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-2.06|STANDARD_ERROR_OF_MEAN|1.9||0.278|TWO_SIDED||||||Mixed Models Analysis|||||||0.278
71093895|NCT04950686|141695665|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.04||0.283|TWO_SIDED||||||Mixed Models Analysis|||||||0.283
71093896|NCT04950686|141695665|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.824|TWO_SIDED||||||Mixed Models Analysis|||||||0.824
71093897|NCT04950686|141695666|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.04||0.965|TWO_SIDED||||||Mixed Models Analysis|||||||0.965
70971939|NCT02171611|141450220|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|166.83|STANDARD_ERROR_OF_MEAN|52.6|||TWO_SIDED|90.0|134.25|207.328|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual geometric coefficient variation (gCV).|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||207.328|134.25|
70971940|NCT02171611|141450221|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|182.17|STANDARD_ERROR_OF_MEAN|56.1|||TWO_SIDED|90.0|144.727|229.297|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||229.297|144.727|
70971941|NCT02171611|141450221|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|160.74|STANDARD_ERROR_OF_MEAN|52.0|||TWO_SIDED|90.0|129.633|199.306|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||199.306|129.633|
70971942|NCT02171611|141450222|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|182.25|STANDARD_ERROR_OF_MEAN|55.7|||TWO_SIDED|90.0|144.993|229.075|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||229.075|144.993|
70971943|NCT02171611|141450222|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|164.01|STANDARD_ERROR_OF_MEAN|51.7|||TWO_SIDED|90.0|132.421|203.14|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||203.14|132.421|
70971944|NCT04249687|141450240|SUPERIORITY|||||||0.05|||||||Cochran-Mantel-Haenszel|||||||0.05
70971945|NCT04249687|141450241|SUPERIORITY|||||||0.05|||||||Cochran-Mantel-Haenszel|||||||0.05
70971946|NCT04036968|141450242|SUPERIORITY|Comparison of three drug conditions with cannabidiol to control groups placebo+placebo and hydromorphone+placebo||||||0.195|||||||ANOVA|||||||0.195
70971947|NCT04036968|141450243|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
70971948|NCT04036968|141450244|SUPERIORITY|||||||0.074|||||||ANOVA|||||||0.074
70971949|NCT01110200|141450274|SUPERIORITY_OR_OTHER||Treatment comparison ratio|0.917||||0.71|TWO_SIDED|95.0|0.581|1.447|||Negative bionomial regression model||Annualized rate estimates, the treatment comparison ratio, the confidence interval, and the p-value are from a negative binomial regression model with terms for treatment, country, randomization stratum, baseline severity, and time on treatment.|||1.447|0.581|0.710
71031856|NCT04239872|141572420|SUPERIORITY||Mean Difference (Net)|1.549|||<|0.0001|TWO_SIDED|95.0|1.081|2.017||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 14 pairs of data, DF=13|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||2.017|1.081|<0.0001
71154017|NCT06072170|141800226|OTHER|Proportionality analysis was done using a power model.|Slope|0.967|||||TWO_SIDED|90.0|0.79|1.145||||||Statistical Analysis for Dose-Proportionality of Speciogynine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.145|0.790|
70971950|NCT01332357|141450290|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.96|||<|0.0001|TWO_SIDED|95.0|1.56|2.46||The unadjusted risk of experiencing a recurrent event associated with not initiating a controller medication at index event discharge|Regression, Cox|||||2.46|1.56|<0.0001
70971951|NCT01332357|141450290|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.79|||<|0.0001|TWO_SIDED|95.0|1.42|2.25||The adjusted risk of experiencing a recurrent event associated with not initiating a controller medication at index event discharge|Regression, Cox|Covariates included demographics, IP or ED index event, primary asthma diagnosis, Charlson score, and pre-index medication||||2.25|1.42|<0.0001
70971952|NCT01332357|141450290|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.008|||<|0.0001|TWO_SIDED|95.0|1.005|1.011||The risk of experiencing a recurrent event associated with not initiating a controller medication at index event discharge by time interaction|Regression, Cox|Evaluates the impact of each day treatment with a controller was delayed||||1.011|1.005|<0.0001
70971953|NCT04311502|141450291|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.21|TWO_SIDED|90.0|0.82|1.79|||Regression, Cox|Adjusted for HIV-1 status (positive/negative) and TB Disease at Screening (Advanced/Not Advanced).|Arm 1 vs Arm 2|This comparison is adjusting for HIV-1 status (positive/negative) and TB Disease at Screening (Advanced/Not Advanced).||1.79|0.82|0.21
70971954|NCT04311502|141450292|SUPERIORITY||Risk Difference (RD)|0.3|||<|0.01|TWO_SIDED|90.0|0.14|0.45|||Wald chi-square test||Difference in cumulative proportions (Arm 1 - Arm 2)|"The point estimate and 90% two-sided confidence intervals for the difference in cumulative proportions of participants experiencing a Grade 3 or higher AE that is at least one-grade increase from baseline at any time during the 65-week study period was compared between Arm 1 and Arm 2.~This outcome measure is limited to data obtained up to September 25, 2023."||0.45|0.14|<0.01
70918951|NCT02528188|141328707|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|1.14||0.4991|TWO_SIDED|95.0|-3.0|1.46|||ANCOVA|||Week 24: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.46|-3.00|0.4991
70918952|NCT02528188|141328707|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|1.44||0.2377|TWO_SIDED|95.0|-1.12|4.52|||ANCOVA|||Week 56: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||4.52|-1.12|0.2377
70918953|NCT02528188|141328707|SUPERIORITY||LS Mean Difference|3.26|STANDARD_ERROR_OF_MEAN|1.44||0.0238|TWO_SIDED|95.0|0.43|6.08|||ANCOVA|||Week 56: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||6.08|0.43|0.0238
70918954|NCT02528188|141328715|SUPERIORITY||LS Mean Difference|2.66|STANDARD_ERROR_OF_MEAN|1.08||0.0142|TWO_SIDED|95.0|0.53|4.78|||ANCOVA|||TSQM Effectiveness; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||4.78|0.53|0.0142
70918955|NCT02528188|141328715|SUPERIORITY||LS Mean Difference|4.67|STANDARD_ERROR_OF_MEAN|1.08|<|0.0001|TWO_SIDED|95.0|2.56|6.78|||ANCOVA|||TSQM Effectiveness; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||6.78|2.56|<0.0001
70918956|NCT02528188|141328715|SUPERIORITY||LS Mean Difference|2.15|STANDARD_ERROR_OF_MEAN|1.45||0.1371|TWO_SIDED|95.0|-0.69|4.99|||ANCOVA|||TSQM Effectiveness; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||4.99|-0.69|0.1371
70918957|NCT02528188|141328715|SUPERIORITY||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|1.46||0.8524|TWO_SIDED|95.0|-2.6|3.14|||ANCOVA|||TSQM Effectiveness; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||3.14|-2.60|0.8524
70918958|NCT02528188|141328715|SUPERIORITY||LS Mean Difference|-2.42|STANDARD_ERROR_OF_MEAN|3.8||0.5253|TWO_SIDED|95.0|-9.93|5.09|||ANCOVA|||TSQM Side Effects; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||5.09|-9.93|0.5253
70918959|NCT02528188|141328715|SUPERIORITY||LS Mean Difference|2.29|STANDARD_ERROR_OF_MEAN|3.71||0.5381|TWO_SIDED|95.0|-5.04|9.62|||ANCOVA|||TSQM Side Effects; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||9.62|-5.04|0.5381
70918960|NCT02528188|141328715|SUPERIORITY||LS Mean Difference|7.27|STANDARD_ERROR_OF_MEAN|6.44||0.2694|TWO_SIDED|95.0|-5.99|20.54|||ANCOVA|||TSQM Side Effects; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||20.54|-5.99|0.2694
70918961|NCT02528188|141328715|SUPERIORITY||LS Mean Difference|-9.34|STANDARD_ERROR_OF_MEAN|6.05||0.1349|TWO_SIDED|95.0|-21.8|3.11|||ANCOVA|||TSQM Side Effects; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||3.11|-21.80|0.1349
70918962|NCT02528188|141328715|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.81||0.0264|TWO_SIDED|95.0|0.21|3.38|||ANCOVA|||TSQM Convenience; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||3.38|0.21|0.0264
70918963|NCT02528188|141328715|SUPERIORITY||LS Mean Difference|2.07|STANDARD_ERROR_OF_MEAN|0.8||0.0098|TWO_SIDED|95.0|0.5|3.65|||ANCOVA|||TSQM Convenience; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||3.65|0.50|0.0098
71031857|NCT04239872|141572421|SUPERIORITY||Mean Difference (Net)|-115.6||||0.5543|TWO_SIDED|95.0|-584.8|353.6||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 6 pairs of data, DF=5|Treatment difference = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups.||353.6|-584.8|0.5543
70918964|NCT02528188|141328715|SUPERIORITY||LS Mean Difference|1.85|STANDARD_ERROR_OF_MEAN|1.1||0.0937|TWO_SIDED|95.0|-0.31|4.01|||ANCOVA|||TSQM Convenience; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||4.01|-0.31|0.0937
70918965|NCT02528188|141328715|SUPERIORITY||LS Mean Difference|1.48|STANDARD_ERROR_OF_MEAN|1.11||0.1838|TWO_SIDED|95.0|-0.7|3.67|||ANCOVA|||TSQM Convenience; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||3.67|-0.70|0.1838
70918966|NCT02528188|141328715|SUPERIORITY||LS Mean Difference|3.18|STANDARD_ERROR_OF_MEAN|1.05||0.0025|TWO_SIDED|95.0|1.12|5.25|||ANCOVA|||TSQM Global Satisfaction; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||5.25|1.12|0.0025
71154018|NCT06072170|141800226|OTHER|Proportionality analysis was done using a power model.|Slope|1.025|||||TWO_SIDED|90.0|0.859|1.191||||||Statistical Analysis for Dose-Proportionality of Speciociliatine Dose Adjusted Pharmacokinetic Parameters (Pharmacokinetic Population)||1.191|0.859|
70971955|NCT04311502|141450292|SUPERIORITY||Risk Difference (RD)|0.28|||<|0.01|TWO_SIDED|90.0|0.11|0.44|||Wald chi-square test||Difference in cumulative proportions (Arm 1 - Arm 2)|"The point estimate and 90% two-sided confidence intervals for the difference in cumulative proportions of participants experiencing a Grade 3 or higher AE that is at least one-grade increase from baseline at any time during the 65-week study period was compared between Arm 1 and Arm 2.~All data through week 65."||0.44|0.11|<0.01
70918967|NCT02528188|141328715|SUPERIORITY||LS Mean Difference|3.55|STANDARD_ERROR_OF_MEAN|1.04||0.0007|TWO_SIDED|95.0|1.51|5.6|||ANCOVA|||TSQM Global Satisfaction; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||5.60|1.51|0.0007
70918968|NCT02528188|141328715|SUPERIORITY||LS Mean Difference|1.94|STANDARD_ERROR_OF_MEAN|1.31||0.1373|TWO_SIDED|95.0|-0.62|4.51|||ANCOVA|||TSQM Global Satisfaction; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||4.51|-0.62|0.1373
70918969|NCT02528188|141328715|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|1.32||0.996|TWO_SIDED|95.0|-2.59|2.6|||ANCOVA|||TSQM Global Satisfaction; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||2.60|-2.59|0.9960
70918970|NCT02528188|141328717|SUPERIORITY|||||||0.0823|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.0823
70918971|NCT02528188|141328717|SUPERIORITY|||||||0.0049|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.0049
70918972|NCT02528188|141328717|SUPERIORITY|||||||0.0718|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.0718
70918973|NCT02528188|141328717|SUPERIORITY|||||||0.1947|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.1947
70918974|NCT02528188|141328718|SUPERIORITY|||||||0.0229|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.0229
70918975|NCT02528188|141328718|SUPERIORITY|||||||0.0029|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.0029
70918976|NCT02528188|141328718|SUPERIORITY|||||||0.0266|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.0266
70918977|NCT02528188|141328718|SUPERIORITY|||||||0.1835|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.1835
70918978|NCT02528188|141328719|SUPERIORITY||Odds Ratio (OR)|0.63||||0.0076|TWO_SIDED|95.0|0.45|0.88|||Regression, Logistic|||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline diary average pain, baseline WOMAC pain score, classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||0.88|0.45|0.0076
70918979|NCT02528188|141328719|SUPERIORITY||Odds Ratio (OR)|0.67||||0.0187|TWO_SIDED|95.0|0.48|0.94|||Regression, Logistic|||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline diary average pain, baseline WOMAC pain score, classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||0.94|0.48|0.0187
70918980|NCT02528188|141328720|SUPERIORITY|||||||0.0074|||||||Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.0074
70971956|NCT04311502|141450293|SUPERIORITY||Risk Difference (RD)|-0.26||||0.01|TWO_SIDED|95.0|-0.47|-0.06|||Wald chi-square test||Difference in cumulative proportions (Arm 1 - Arm 2)|The point estimate and 95% two-sided confidence interval for the difference in cumulative proportions of participants experiencing a favorable outcome through week 65 was compared between Arm 1 and Arm 2.||-0.06|-0.47|0.01
70918981|NCT02528188|141328720|SUPERIORITY|||||||0.0162|||||||Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.0162
70918982|NCT02528188|141328721|SUPERIORITY||Odds Ratio (OR)|1.15||||0.1136|TWO_SIDED|95.0|0.97|1.38|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.38|0.97|0.1136
70918983|NCT02528188|141328721|SUPERIORITY||Odds Ratio (OR)|1.08||||0.391|TWO_SIDED|95.0|0.9|1.29|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.29|0.90|0.3910
70918984|NCT02528188|141328721|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7691|TWO_SIDED|95.0|0.86|1.22|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.22|0.86|0.7691
70971957|NCT04311502|141450294|SUPERIORITY||Risk Difference (RD)|-0.25||||0.02|TWO_SIDED|95.0|-0.46|-0.04|||Wald chi-square||Difference in cumulative proportions (Arm 1 - Arm 2)|The point estimate and 95% two-sided confidence interval for the difference in cumulative proportions of participants experiencing a favorable outcome through week 65 was compared between Arm 1 and Arm 2.||-0.04|-0.46|0.02
71154019|NCT06072170|141800230|SUPERIORITY||Least-Square Mean|18.5|STANDARD_ERROR_OF_MEAN|6.06|||TWO_SIDED|95.0|6.16|30.78||||||||30.78|6.16|
71093898|NCT04950686|141695666|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.902|TWO_SIDED||||||Mixed Models Analysis|||||||0.902
71093899|NCT04950686|141695667|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.04||0.074|TWO_SIDED||||||Mixed Models Analysis|||||||0.074
71093900|NCT04950686|141695667|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.828|TWO_SIDED||||||Mixed Models Analysis|||||||0.828
70918985|NCT02528188|141328721|SUPERIORITY||Odds Ratio (OR)|0.88||||0.143|TWO_SIDED|95.0|0.73|1.05|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.05|0.73|0.1430
70918986|NCT02528188|141328721|SUPERIORITY||Odds Ratio (OR)|1.04||||0.6454|TWO_SIDED|95.0|0.87|1.25|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.25|0.87|0.6454
70918987|NCT02528188|141328721|SUPERIORITY||Odds Ratio (OR)|0.84||||0.0561|TWO_SIDED|95.0|0.7|1.0|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.00|0.70|0.0561
70918988|NCT02528188|141328721|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9056|TWO_SIDED|95.0|0.82|1.19|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.19|0.82|0.9056
70918989|NCT02528188|141328721|SUPERIORITY||Odds Ratio (OR)|0.9||||0.2919|TWO_SIDED|95.0|0.75|1.09|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.09|0.75|0.2919
70918990|NCT02528188|141328721|SUPERIORITY||Odds Ratio (OR)|0.94||||0.4976|TWO_SIDED|95.0|0.78|1.13|||Regression, Logistic|||Week 24: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.13|0.78|0.4976
70918991|NCT02528188|141328721|SUPERIORITY||Odds Ratio (OR)|0.9||||0.2425|TWO_SIDED|95.0|0.75|1.08|||Regression, Logistic|||Week 24: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.08|0.75|0.2425
70918992|NCT02528188|141328721|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9242|TWO_SIDED|95.0|0.83|1.19|||Regression, Logistic|||Week 32: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.19|0.83|0.9242
70918993|NCT02528188|141328721|SUPERIORITY||Odds Ratio (OR)|0.96||||0.6621|TWO_SIDED|95.0|0.8|1.15|||Regression, Logistic|||Week 32: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.15|0.80|0.6621
70918994|NCT02528188|141328721|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9977|TWO_SIDED|95.0|0.83|1.2|||Regression, Logistic|||Week 40: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.20|0.83|0.9977
70918995|NCT02528188|141328721|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9762|TWO_SIDED|95.0|0.84|1.2|||Regression, Logistic|||Week 40: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.20|0.84|0.9762
70918996|NCT02528188|141328721|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9718|TWO_SIDED|95.0|0.83|1.19|||Regression, Logistic|||Week 48: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.19|0.83|0.9718
71093901|NCT04950686|141695668|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.25||0.336|TWO_SIDED||||||Mixed Models Analysis|||||||0.336
71093902|NCT04950686|141695668|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.28||0.902|TWO_SIDED||||||Mixed Models Analysis|||||||0.902
71154020|NCT06072170|141800233|SUPERIORITY||Least-Squared Mean|45.9|STANDARD_ERROR_OF_MEAN|7.74|<|0.001|TWO_SIDED|95.0|30.2|61.67|||ANOVA|||Statistical Analysis for High Visual Analog Scale (Emax)||61.67|30.20|<0.001
71093903|NCT04950686|141695669|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.24||0.629|TWO_SIDED||||||Mixed Models Analysis|||||||0.629
71093904|NCT04950686|141695669|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.29||0.318|TWO_SIDED||||||Mixed Models Analysis|||||||0.318
71093905|NCT04950686|141695670|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.24||0.863|TWO_SIDED||||||Mixed Models Analysis|||||||0.863
71093906|NCT04950686|141695670|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.29||0.299|TWO_SIDED||||||Mixed Models Analysis|||||||0.299
71093907|NCT04950686|141695671|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.010
70918997|NCT02528188|141328721|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8219|TWO_SIDED|95.0|0.85|1.22|||Regression, Logistic|||Week 48: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.22|0.85|0.8219
71031858|NCT04239872|141572422|SUPERIORITY||Mean Difference (Net)|1.328||||0.0003|TWO_SIDED|95.0|0.842|1.814||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 8 pairs of data, DF=7|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.814|0.8420|0.0003
71031859|NCT04239872|141572423|SUPERIORITY||Mean Difference (Net)|-0.09023||||0.2824|TWO_SIDED|95.0|-0.2613|0.08082||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 19 pairs of data, DF=18|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.08082|-0.2613|0.2824
71031860|NCT04239872|141572424|SUPERIORITY||Mean Difference (Net)|0.6269||||0.0002|TWO_SIDED|95.0|0.3488|0.905||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 17 pairs of data, DF=16|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.9050|0.3488|0.0002
71031861|NCT04239872|141572425|SUPERIORITY||Mean Difference (Net)|0.8946|||<|0.0001|TWO_SIDED|95.0|0.6671|1.122||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 17 pairs of data, DF=16|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.122|0.6671|<0.0001
71031862|NCT04239872|141572426|SUPERIORITY||Mean Difference (Net)|0.973|||<|0.0001|TWO_SIDED|95.0|0.7597|1.186||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 18 pairs of data, DF=17|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.186|0.7597|<0.0001
71031863|NCT04239872|141572427|SUPERIORITY||Mean Difference (Net)|0.9827|||<|0.0001|TWO_SIDED|95.0|0.7758|1.19||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 18 pairs of data, DF=17|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.19|0.7758|<0.0001
71031864|NCT04239872|141572428|SUPERIORITY||Mean Difference (Net)|0.9181|||<|0.0001|TWO_SIDED|95.0|0.6573|1.179||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 19 pairs of data, DF=18|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.179|0.6573|<0.0001
71031865|NCT04239872|141572433|SUPERIORITY||Mean Difference (Net)|-0.05652||||0.3283|TWO_SIDED|95.0|-0.1762|0.06829||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 15 pairs of data, DF=14|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.06829|-0.1762|0.3283
71031866|NCT04239872|141572434|SUPERIORITY||Mean Difference (Net)|0.3411||||0.0058|TWO_SIDED|95.0|0.1189|0.5633||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 13 pairs of data, DF=12|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.5633|0.1189|0.0058
71093908|NCT04950686|141695671|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.05||0.119|TWO_SIDED||||||Mixed Models Analysis|||||||0.119
71093909|NCT04950686|141695672|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.04||0.161|TWO_SIDED||||||Mixed Models Analysis|||||||0.161
71093910|NCT04950686|141695672|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.087|TWO_SIDED||||||Mixed Models Analysis|||||||0.087
71093911|NCT04950686|141695673|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.81|TWO_SIDED||||||Mixed Models Analysis|||||||0.810
71093912|NCT04950686|141695673|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.901|TWO_SIDED||||||Mixed Models Analysis|||||||0.901
71093913|NCT04950686|141695674|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.145|TWO_SIDED||||||Mixed Models Analysis|||||||0.145
71093914|NCT04950686|141695674|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.096|TWO_SIDED||||||Mixed Models Analysis|||||||0.096
71093915|NCT04950686|141695675|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.08||0.272|TWO_SIDED||||||Mixed Models Analysis|||||||0.272
71093916|NCT04950686|141695675|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.08||0.689|TWO_SIDED||||||Mixed Models Analysis|||||||0.689
71093917|NCT04950686|141695676|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.08||0.824|TWO_SIDED||||||Mixed Models Analysis|||||||0.824
71093918|NCT04950686|141695676|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.271|TWO_SIDED||||||Mixed Models Analysis|||||||0.271
71093919|NCT04950686|141695677|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.04||0.391|TWO_SIDED||||||Mixed Models Analysis|||||||0.391
71093920|NCT04950686|141695677|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.04||0.952|TWO_SIDED||||||Mixed Models Analysis|||||||0.952
71093921|NCT04950686|141695678|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.004|STANDARD_ERROR_OF_MEAN|0.04||0.925|TWO_SIDED||||||Mixed Models Analysis|||||||0.925
71093922|NCT04950686|141695678|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.05||0.153|TWO_SIDED||||||Mixed Models Analysis|||||||0.153
71093923|NCT04950686|141695679|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.495|TWO_SIDED||||||Mixed Models Analysis|||||||0.495
71093924|NCT04950686|141695679|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.06||0.229|TWO_SIDED||||||Mixed Models Analysis|||||||0.229
70918998|NCT02528188|141328721|SUPERIORITY||Odds Ratio (OR)|0.96||||0.6936|TWO_SIDED|95.0|0.8|1.16|||Regression, Logistic|||Week 56: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.16|0.80|0.6936
70918999|NCT02528188|141328721|SUPERIORITY||Odds Ratio (OR)|1.05||||0.5769|TWO_SIDED|95.0|0.88|1.26|||Regression, Logistic|||Week 56: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.26|0.88|0.5769
70919000|NCT02528188|141328723|SUPERIORITY||LS Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.07||0.7746|TWO_SIDED|95.0|0.89|1.16|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.16|0.89|0.7746
70919001|NCT02528188|141328723|SUPERIORITY||LS Mean Ratio|1.01|STANDARD_ERROR_OF_MEAN|0.07||0.8441|TWO_SIDED|95.0|0.89|1.16|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.16|0.89|0.8441
71031867|NCT04239872|141572435|SUPERIORITY||Mean Difference (Net)|0.2976||||0.0213|TWO_SIDED|95.0|0.05266|0.5426||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 13 pairs of data, DF=12|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.5426|0.05266|0.0213
71031868|NCT04239872|141572436|SUPERIORITY||Mean Difference (Net)|0.312||||0.014|TWO_SIDED|95.0|0.07454|0.5495||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 14 pairs of data, DF=13|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.5495|0.07454|0.014
71031869|NCT04239872|141572437|SUPERIORITY||Mean Difference (Net)|0.2524||||0.1393|TWO_SIDED|95.0|-0.09153|0.5962||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 17 pairs of data, DF=16|Treatment difference = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups.||0.5962|-0.09153|0.1393
71031870|NCT04239872|141572438|SUPERIORITY||Mean Difference (Net)|0.2921||||0.0009|TWO_SIDED|95.0|0.1414|0.4427||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 16 pairs of data, DF=15|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.4427|0.1414|0.0009
71031871|NCT04239872|141572439|SUPERIORITY||Mean Difference (Net)|0.2433||||0.0008|TWO_SIDED|95.0|0.1195|0.3671||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 16 pairs of data, DF=15|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.3671|0.1195|0.0008
71031872|NCT04239872|141572440|SUPERIORITY||Mean Difference (Net)|0.3306||||0.1515|TWO_SIDED|95.0|-0.1356|0.7969||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 16 pairs of data, DF=15|Treatment difference = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups.||0.7969|-0.1356|0.1515
71031873|NCT04239872|141572441|SUPERIORITY||Mean Difference (Net)|0.04851||||0.1712|TWO_SIDED|95.0|-0.02327|0.1203||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 17 pairs of data, DF=16|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.1203|-0.02327|0.1712
71031874|NCT04239872|141572442|SUPERIORITY||Mean Difference (Net)|0.2789||||0.1188|TWO_SIDED|95.0|-0.07934|0.6371||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 18 pairs of data, DF=17|Treatment difference = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups.||0.6371|-0.07934|0.1188
71031875|NCT04239872|141572443|SUPERIORITY||Mean Difference (Net)|0.8956|||<|0.0001|TWO_SIDED|95.0|0.7205|1.071||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 14 pairs of data, DF=13|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.071|0.7205|<0.0001
71031876|NCT04239872|141572445|SUPERIORITY||Mean Difference (Net)|0.3199||||0.0475|TWO_SIDED|95.0|0.004686|0.6351||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 8 pairs of data, DF=7|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.6351|0.004686|0.0475
71031877|NCT04239872|141572446|SUPERIORITY||Mean Difference (Net)|50.38||||0.0004|TWO_SIDED|95.0|27.46|73.3||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 13 pairs of data, DF=12|Treatment difference = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups.||73.30|27.46|0.0004
71031878|NCT02819323|141572447|NON_INFERIORITY|Non-inferiority margin = 10%||||||0.003|||||||Cochran-Mantel-Haenszel|||||||0.003
71031879|NCT02819323|141572447|NON_INFERIORITY|Non-inferiority margin = 10%||||||0.003|||||||Cochran-Mantel-Haenszel|||||||0.003
71031880|NCT02819323|141572447|SUPERIORITY|||||||0.046|||||||Cochran-Mantel-Haenszel|||||||0.046
71031881|NCT02819323|141572447|SUPERIORITY|||||||0.089|||||||Cochran-Mantel-Haenszel|||||||0.089
71031882|NCT00854100|141572479|SUPERIORITY||Least Squares Mean Difference|0.5||||0.746|TWO_SIDED|95.0|-2.4|3.4|||ANCOVA|||||3.4|-2.4|0.746
71093925|NCT04950686|141695680|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.753|TWO_SIDED||||||Mixed Models Analysis|||||||0.753
71093926|NCT04950686|141695680|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.35|TWO_SIDED||||||Mixed Models Analysis|||||||0.350
71093927|NCT04950686|141695681|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.05||0.541|TWO_SIDED||||||Mixed Models Analysis|||||||0.541
71093928|NCT04950686|141695681|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.887|TWO_SIDED||||||Mixed Models Analysis|||||||0.887
71093929|NCT04950686|141695682|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.05||0.375|TWO_SIDED||||||Mixed Models Analysis|||||||0.375
71093930|NCT04950686|141695682|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.06||0.293|TWO_SIDED||||||Mixed Models Analysis|||||||0.293
71093931|NCT04950686|141695683|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-5.97|STANDARD_ERROR_OF_MEAN|1.89||0.002|TWO_SIDED||||||Mixed Models Analysis|||||||0.002
71093932|NCT04950686|141695683|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.08|STANDARD_ERROR_OF_MEAN|2.21||0.163|TWO_SIDED||||||Mixed Models Analysis|||||||0.163
71093933|NCT04950686|141695684|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-5.09|STANDARD_ERROR_OF_MEAN|1.99||0.011|TWO_SIDED||||||Mixed Models Analysis|||||||0.011
71093934|NCT04950686|141695684|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.21|STANDARD_ERROR_OF_MEAN|2.27||0.159|TWO_SIDED||||||Mixed Models Analysis|||||||0.159
71093935|NCT04950686|141695685|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.83|STANDARD_ERROR_OF_MEAN|2.06||0.064|TWO_SIDED||||||Mixed Models Analysis|||||||0.064
71093936|NCT04950686|141695685|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.37|STANDARD_ERROR_OF_MEAN|2.27||0.137|TWO_SIDED||||||Mixed Models Analysis|||||||0.137
71093937|NCT04950686|141695686|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-5.05|STANDARD_ERROR_OF_MEAN|1.52||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||0.001
71093938|NCT04950686|141695686|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.25|STANDARD_ERROR_OF_MEAN|1.76||0.065|TWO_SIDED||||||Mixed Models Analysis|||||||0.065
71093939|NCT04950686|141695687|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.67|STANDARD_ERROR_OF_MEAN|1.51||0.015|TWO_SIDED||||||Mixed Models Analysis|||||||0.015
71093940|NCT04950686|141695687|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-2.56|STANDARD_ERROR_OF_MEAN|1.78||0.152|TWO_SIDED||||||Mixed Models Analysis|||||||0.152
71093941|NCT04950686|141695688|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.78|STANDARD_ERROR_OF_MEAN|1.78||0.034|TWO_SIDED||||||Mixed Models Analysis|||||||0.034
71093942|NCT04950686|141695688|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.13|STANDARD_ERROR_OF_MEAN|1.84||0.09|TWO_SIDED||||||Mixed Models Analysis|||||||0.090
71093943|NCT04950686|141695689|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.04||0.282|TWO_SIDED||||||Mixed Models Analysis|||||||0.282
71093944|NCT04950686|141695689|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.532|TWO_SIDED||||||Mixed Models Analysis|||||||0.532
70919002|NCT02528188|141328723|SUPERIORITY||LS Mean Ratio|0.97|STANDARD_ERROR_OF_MEAN|0.08||0.658|TWO_SIDED|95.0|0.83|1.13|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.13|0.83|0.6580
70919003|NCT02528188|141328723|SUPERIORITY||LS Mean Ratio|0.91|STANDARD_ERROR_OF_MEAN|0.07||0.2279|TWO_SIDED|95.0|0.78|1.06|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.06|0.78|0.2279
70919004|NCT02528188|141328723|SUPERIORITY||LS Mean Ratio|1.0|STANDARD_ERROR_OF_MEAN|0.09||0.9986|TWO_SIDED|95.0|0.84|1.18|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.18|0.84|0.9986
70919005|NCT02528188|141328723|SUPERIORITY||LS Mean Ratio|0.86|STANDARD_ERROR_OF_MEAN|0.07||0.0771|TWO_SIDED|95.0|0.72|1.02|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.02|0.72|0.0771
70919006|NCT02528188|141328723|SUPERIORITY||LS Mean Ratio|0.93|STANDARD_ERROR_OF_MEAN|0.09||0.4485|TWO_SIDED|95.0|0.77|1.13|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.13|0.77|0.4485
70919007|NCT02528188|141328723|SUPERIORITY||LS Mean Ratio|0.9|STANDARD_ERROR_OF_MEAN|0.09||0.2817|TWO_SIDED|95.0|0.74|1.09|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.09|0.74|0.2817
70919008|NCT02528188|141328723|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.09||0.5426|TWO_SIDED|95.0|0.79|1.13|||Negative binomial model|||Week 24: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.13|0.79|0.5426
70919009|NCT02528188|141328723|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.09||0.5385|TWO_SIDED|95.0|0.79|1.13|||Negative binomial model|||Week 24: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.13|0.79|0.5385
70919010|NCT02528188|141328723|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.09||0.5041|TWO_SIDED|95.0|0.79|1.12|||Negative binomial model|||Week 32: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.12|0.79|0.5041
70919011|NCT02528188|141328723|SUPERIORITY||LS Mean Ratio|0.93|STANDARD_ERROR_OF_MEAN|0.08||0.441|TWO_SIDED|95.0|0.78|1.11|||Negative binomial model|||Week 32: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.11|0.78|0.4410
70919012|NCT02528188|141328723|SUPERIORITY||LS Mean Ratio|0.97|STANDARD_ERROR_OF_MEAN|0.09||0.7426|TWO_SIDED|95.0|0.81|1.16|||Negative binomial model|||Week 40: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.16|0.81|0.7426
70919013|NCT02528188|141328723|SUPERIORITY||LS Mean Ratio|0.97|STANDARD_ERROR_OF_MEAN|0.09||0.7469|TWO_SIDED|95.0|0.81|1.16|||Negative binomial model|||Week 40: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.16|0.81|0.7469
70919014|NCT02528188|141328723|SUPERIORITY||LS Mean Ratio|0.96|STANDARD_ERROR_OF_MEAN|0.09||0.6784|TWO_SIDED|95.0|0.81|1.15|||Negative binomial model|||Week 48: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.15|0.81|0.6784
70919015|NCT02528188|141328723|SUPERIORITY||LS Mean Ratio|1.01|STANDARD_ERROR_OF_MEAN|0.09||0.8822|TWO_SIDED|95.0|0.85|1.21|||Negative binomial model|||Week 48: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.21|0.85|0.8822
70971958|NCT04311502|141450295|SUPERIORITY|Fisher's exact test was used to test for a difference in proportions|Risk Difference (RD)|-0.06||||0.35|TWO_SIDED|95.0|-0.22|0.05|||Fisher Exact||Difference in proportions (Arm 1 - Arm 2); exact confidence interval|||0.05|-0.22|0.35
71154021|NCT00861705|141800287|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0018|||||||Chi-squared|Reported p-values are unadjusted and 1-sided||The study was designed to detect an increase in the incidence of pCR from 35% in the control arm to 55% in the experimental arm using a 1-sided chi square test of proportions. With a target sample of 362 patients and assuming a 10% dropout rate, an overall assessable sample size of 326 patients resulted in \> 95% power.||||0.0018
70971959|NCT04311502|141450297|SUPERIORITY||GEE|24.04|||<|0.01|TWO_SIDED|95.0|15.13|32.94|||Regression, Linear|||||32.94|15.13|<0.01
70971960|NCT04311502|141450299|SUPERIORITY||Odds Ratio (OR)|7.15|||<|0.01|TWO_SIDED|95.0|2.4|21.3|||Regression, Logistic|||Compares the odds of participants having maximum occurrence of QTcF change from baseline of ≥30 ms and \<60 ms, or ≥60 ms between Arm 1 and Arm 2 in the safety set using the proportional odds model.||21.30|2.40|<0.01
70971961|NCT04311502|141450299|SUPERIORITY||Risk Difference (RD)|0.41|||<|0.01|TWO_SIDED|95.0|0.17|0.58|||exact unconditional||Arm 1 - Arm 2|Proportion of Participants with Worst Changes in QTcF from Screening \>= 30 ms over visits at Weeks 2, 8, 13||0.58|0.17|<0.01
70971962|NCT04311502|141450300|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.18|TWO_SIDED|90.0|0.84|1.8||One-sided p-value|Regression, Cox|Adjusted for HIV status (positive/negative) and TB disease according to chest X-ray (advanced/not advanced)|Arm 1 vs. Arm 2|||1.80|0.84|0.18
70971963|NCT04311502|141450301|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.25|TWO_SIDED|90.0|0.8|1.71||One-sided p-value|Regression, Cox|||This comparison is adjusting for HIV-1 status (positive/negative) and TB Disease at Screening (Advanced/Not Advanced).||1.71|0.80|0.25
70971964|NCT04311502|141450302|SUPERIORITY||Risk Difference (RD)|0.13||||0.23|TWO_SIDED|95.0|-0.07|0.35|||Fisher Exact|||||0.35|-0.07|0.23
70971965|NCT04311502|141450303|SUPERIORITY||Risk Difference (RD)|0.05||||0.56|TWO_SIDED|95.0|-0.11|0.24|||Fisher Exact|||||0.24|-0.11|0.56
70971966|NCT04311502|141450304|SUPERIORITY||Risk Difference (RD)|0.07||||0.27|TWO_SIDED|90.0|-0.04|0.18|||Wald chi-square test||Difference in cumulative proportions (Arm 1 - Arm 2)|The point estimate and 90% two-sided confidence intervals for the difference in cumulative proportions of participants experiencing an SAE through week 65 was compared between Arm 1 and Arm 2.||0.18|-0.04|0.27
70971967|NCT04311502|141450305|SUPERIORITY|Fisher's exact test was used to test for a difference in proportions|Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-0.1|0.13|||Fisher Exact||Difference in proportions (Arm 1 - Arm 2); exact confidence interval|||0.13|-0.10|1
70971968|NCT04311502|141450306|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.597|TWO_SIDED|95.0|0.57|1.39|||Regression, Cox|||Time point: Screening||1.39|0.57|0.597
70971969|NCT04311502|141450306|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.7|TWO_SIDED|95.0|0.58|1.44|||Regression, Cox|||Time point: Entry||1.44|0.58|0.70
70971970|NCT04311502|141450306|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.07|TWO_SIDED|95.0|0.4|1.03|||Regression, Cox|||Time point: Week 2||1.03|0.40|0.07
70971971|NCT04311502|141450306|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.04|TWO_SIDED|95.0|0.34|0.98|||Regression, Cox|||Time point: Week 4||0.98|0.34|0.04
70971972|NCT04311502|141450306|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.6|TWO_SIDED|95.0|0.41|1.67|||Regression, Cox|||Time point: Week 6||1.67|0.41|0.60
70971973|NCT04311502|141450306|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.595|TWO_SIDED|95.0|0.33|1.88|||Regression, Cox|||Time point: Week 8||1.88|0.33|0.595
70971974|NCT04311502|141450306|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.66|TWO_SIDED|95.0|0.25|2.44|||Regression, Cox|||Time point: Week 10||2.44|0.25|0.66
70971975|NCT04311502|141450306|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.86|TWO_SIDED|95.0|0.21|6.39|||Regression, Cox|||Time point: Week 12||6.39|0.21|0.86
70971976|NCT04311502|141450307|SUPERIORITY||Slope|20.43|||<|0.01|TWO_SIDED|95.0|5.71|35.16|||Regression, Linear|||This comparison is adjusting for HIV-1 status (positive/negative) and TB Disease at Screening (Advanced/Not Advanced).||35.16|5.71|<0.01
70971977|NCT03040999|141450319|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.1997|TWO_SIDED|95.0|0.71|1.15|||Log Rank|One-sided p-value based on log-rank test stratified by human papilloma virus (HPV) status and overall cancer stage.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by HPV status and overall cancer stage.|||1.15|0.71|0.1997
71154022|NCT00861705|141800288|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0089|||||||Chi-squared|Reported p-values are unadjusted and 1-sided||The study was designed to detect an increase in the incidence of pCR from 35% in the control arm to 55% in the experimental arm using a 1-sided chi square test of proportions. With a target sample of 362 patients and assuming a 10% dropout rate, an overall assessable sample size of 326 patients resulted in \> 95% power.||||0.0089
70971978|NCT03040999|141450322|OTHER||Difference in Least squares mean|-4.24||||0.0015|TWO_SIDED|95.0|-6.85|-1.63|||cLDA||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment, time, treatment by time interaction, and stratification factors of HPV status and overall cancer stage.|Difference in Least Squares Mean||-1.63|-6.85|0.0015
70971979|NCT03040999|141450323|OTHER||Difference in Least squares mean|-0.51||||0.7719|TWO_SIDED|95.0|-3.98|2.96|||cLDA||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment, time, treatment by time interaction, and stratification factors of HPV status and overall cancer stage.|Difference in Least Squares Mean||2.96|-3.98|0.7719
70971980|NCT03040999|141450324|OTHER||Difference in Least squares mean|-1.29||||0.45|TWO_SIDED|95.0|-4.64|2.06|||cLDA||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment, time, treatment by time interaction, and stratification factors of HPV status and overall cancer stage.|Difference in Least Squares Mean||2.06|-4.64|0.4500
70971981|NCT03040999|141450325|OTHER||Difference in Least squares mean|1.29||||0.3524|TWO_SIDED|95.0|-1.43|4.02|||cLDA||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment, time, treatment by time interaction, and stratification factors of HPV status and overall cancer stage.|Difference in Least Squares Mean||4.02|-1.43|0.3524
70971982|NCT03040999|141450326|OTHER||Difference in Least squares mean|-2.05||||0.0963|TWO_SIDED|95.0|-4.47|0.37|||cLDA||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment, time, treatment by time interaction, and stratification factors of HPV status and overall cancer stage.|Difference in Least Squares Mean||0.37|-4.47|0.0963
70971983|NCT03040999|141450327|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0429|TWO_SIDED|95.0|0.68|1.03||P-value crossing boundary of 0.0242 required for statistical significance.|Log Rank|One-sided p-value based on log-rank test stratified by human papilloma virus (HPV) status and overall cancer stage.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by HPV status and overall cancer stage.|||1.03|0.68|0.0429
71031883|NCT00854100|141572479|SUPERIORITY||Least Squares Mean Difference|-1.8||||0.227|TWO_SIDED|95.0|-4.8|1.1|||ANCOVA|||||1.1|-4.8|0.227
71031884|NCT00854100|141572480|SUPERIORITY||Least Squares Mean Difference|0.0||||0.918|TWO_SIDED|95.0|-0.3|0.3|||ANCOVA|||||0.3|-0.3|0.918
70919016|NCT02528188|141328723|SUPERIORITY||LS Mean Ratio|0.99|STANDARD_ERROR_OF_MEAN|0.09||0.9119|TWO_SIDED|95.0|0.83|1.18|||Negative binomial model|||Week 56: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.18|0.83|0.9119
70919017|NCT02528188|141328723|SUPERIORITY||LS Mean Ratio|1.06|STANDARD_ERROR_OF_MEAN|0.09||0.5148|TWO_SIDED|95.0|0.89|1.26|||Negative binomial model|||Week 56: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.26|0.89|0.5148
70919018|NCT02528188|141328725|SUPERIORITY||LS Mean Ratio|0.87|STANDARD_ERROR_OF_MEAN|0.13||0.3348|TWO_SIDED|95.0|0.66|1.15|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.15|0.66|0.3348
70919019|NCT02528188|141328725|SUPERIORITY||LS Mean Ratio|0.88|STANDARD_ERROR_OF_MEAN|0.13||0.3595|TWO_SIDED|95.0|0.66|1.16|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.16|0.66|0.3595
70919020|NCT02528188|141328725|SUPERIORITY||LS Mean Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.13||0.0854|TWO_SIDED|95.0|0.54|1.04|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.04|0.54|0.0854
70919021|NCT02528188|141328725|SUPERIORITY||LS Mean Ratio|0.69|STANDARD_ERROR_OF_MEAN|0.12||0.0281|TWO_SIDED|95.0|0.5|0.96|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||0.96|0.50|0.0281
70919022|NCT02528188|141328725|SUPERIORITY||LS Mean Ratio|0.7|STANDARD_ERROR_OF_MEAN|0.13||0.0595|TWO_SIDED|95.0|0.49|1.01|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.01|0.49|0.0595
70919023|NCT02528188|141328725|SUPERIORITY||LS Mean Ratio|0.57|STANDARD_ERROR_OF_MEAN|0.11||0.003|TWO_SIDED|95.0|0.4|0.83|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||0.83|0.40|0.0030
70919024|NCT02528188|141328725|SUPERIORITY||LS Mean Ratio|0.73|STANDARD_ERROR_OF_MEAN|0.15||0.1389|TWO_SIDED|95.0|0.48|1.11|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.11|0.48|0.1389
70919025|NCT02528188|141328725|SUPERIORITY||LS Mean Ratio|0.68|STANDARD_ERROR_OF_MEAN|0.14||0.0709|TWO_SIDED|95.0|0.45|1.03|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.03|0.45|0.0709
70919026|NCT02528188|141328734|SUPERIORITY|||||||0.6037|||||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.6037
70919027|NCT02528188|141328734|SUPERIORITY|||||||0.1928|||||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.1928
70919028|NCT02528188|141328734|SUPERIORITY|||||||0.7204|||||||Cochran-Mantel-Haenszel|||Week 8: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.7204
70919029|NCT02528188|141328734|SUPERIORITY|||||||0.7969|||||||Cochran-Mantel-Haenszel|||Week 8: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.7969
70919030|NCT02528188|141328734|SUPERIORITY|||||||0.7857|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.7857
70919031|NCT02528188|141328734|SUPERIORITY|||||||0.6627|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.6627
70919032|NCT02528188|141328734|SUPERIORITY|||||||0.9867|||||||Cochran-Mantel-Haenszel|||Week 24: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.9867
70919033|NCT02528188|141328734|SUPERIORITY|||||||0.819|||||||Cochran-Mantel-Haenszel|||Week 24: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.8190
70919034|NCT02528188|141328734|SUPERIORITY|||||||0.7284|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.7284
70919035|NCT02528188|141328734|SUPERIORITY|||||||0.1545|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.1545
70919036|NCT03887650|141328758|SUPERIORITY|||||||0.127|||||||Wilcoxon (Mann-Whitney)|||||||0.127
70919037|NCT03887650|141328759|SUPERIORITY|||||||0.975|||||||Wilcoxon (Mann-Whitney)|||||||.975
70919038|NCT03887650|141328760|SUPERIORITY|||||||0.852||||||PACU pain scores|Wilcoxon (Mann-Whitney)|||||||.852
70919039|NCT03887650|141328760|SUPERIORITY|||||||0.661||||||For (PACU-24) minimum pain scores|Wilcoxon (Mann-Whitney)|||||||.661
71031885|NCT00854100|141572480|SUPERIORITY||Least Squares Mean Difference|-0.2||||0.167|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||||0.1|-0.6|0.167
71154023|NCT00861705|141800289|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0029|||||||Chi-squared|Reported p-values are unadjusted and 1-sided||||||0.0029
70919040|NCT03887650|141328760|SUPERIORITY|||||||0.747||||||For (PACU-24 hr.) maximum pain score|Wilcoxon (Mann-Whitney)|||||||.747
70919041|NCT03887650|141328760|SUPERIORITY|||||||0.604||||||For (PACU-24 hr) average pain scores|Wilcoxon (Mann-Whitney)|||||||.604
70919042|NCT03887650|141328760|SUPERIORITY|||||||0.002||||||(24-48 hr) minimum pain scores|Wilcoxon (Mann-Whitney)|||||||.002
70919043|NCT03887650|141328760|SUPERIORITY||||||<|0.01||||||For (24-48 hr) maximum pain scores|Wilcoxon (Mann-Whitney)|||||||<0.01
70919044|NCT03887650|141328760|SUPERIORITY||||||<|0.01||||||For (24-48 hr) average pain scores|Wilcoxon (Mann-Whitney)|||||||<0.01
70919045|NCT03887650|141328760|SUPERIORITY|||||||0.011||||||(48-72 hr) minimum pain scores|Wilcoxon (Mann-Whitney)|||||||.011
70919046|NCT03887650|141328760|SUPERIORITY|||||||0.001||||||(48-72 hr) maximum pain scores|Wilcoxon (Mann-Whitney)|||||||.001
70919047|NCT03887650|141328760|SUPERIORITY|||||||0.003||||||(48-72 hr) average pain scores|Wilcoxon (Mann-Whitney)|||||||.003
70919048|NCT03887650|141328760|SUPERIORITY|||||||0.23||||||For (72-96 hr) minimum pain scores|Wilcoxon (Mann-Whitney)|||||||.230
70919049|NCT03887650|141328760|SUPERIORITY|||||||0.007||||||For (72-96 hr) maximum pain scores|Wilcoxon (Mann-Whitney)|||||||.007
70919050|NCT03887650|141328760|SUPERIORITY|||||||0.011||||||For (72-96 hr) average pain scores|Wilcoxon (Mann-Whitney)|||||||.011
70919051|NCT03887650|141328760|SUPERIORITY|||||||0.378||||||For (postoperative day 60) minimum pain scores|Wilcoxon (Mann-Whitney)|||||||.378
70919052|NCT03887650|141328760|SUPERIORITY|||||||0.001||||||For (postoperative day 60) maximum pain scores|Wilcoxon (Mann-Whitney)|||||||.001
70919053|NCT03887650|141328760|SUPERIORITY|||||||0.403||||||For (postoperative day 60) average pain scores|Wilcoxon (Mann-Whitney)|||||||.403
70919054|NCT03887650|141328761|SUPERIORITY|||||||0.112|||||||Wilcoxon (Mann-Whitney)|||||||.112
70919055|NCT03887650|141328762|SUPERIORITY|||||||0.096||||||P-Value for POD4|Fisher Exact|Fisher's Exact for POD4||||||0.096
70919056|NCT03887650|141328762|SUPERIORITY|||||||1||||||For POD60|Chi-squared|Chi-squared for POD60||||||1.0
70919057|NCT03887650|141328763|SUPERIORITY|||||||1||||||Any distress on PACU|Chi-squared|||||||1.0
70919058|NCT03887650|141328763|SUPERIORITY|||||||0.947||||||Postoperative day 2|Chi-squared|||||||.947
70919059|NCT03887650|141328764|SUPERIORITY|||||||0.441||||||Full sensation|Fishers Freeman Halton|||||||.441
70919060|NCT03887650|141328764|SUPERIORITY|||||||0.691||||||First sensation|Fishers Freeman Halton|||||||.691
70919061|NCT03887650|141328765|SUPERIORITY|||||||0.876|||||||Wilcoxon (Mann-Whitney)|||||||.876
70919062|NCT03887650|141328766|SUPERIORITY|||||||0.011||||||Any movement|Fisher' Freeman Halton|||||||.011
70919063|NCT03887650|141328766|SUPERIORITY|||||||0.536||||||Full movement|Fishers Freeman Halton|||||||.536
70919064|NCT03887650|141328767|SUPERIORITY|||||||0.648||||||MME 0-24|Wilcoxon (Mann-Whitney)|||||||.648
70919065|NCT03887650|141328767|SUPERIORITY|||||||0.285||||||MME24-48|Wilcoxon (Mann-Whitney)|||||||.285
70919066|NCT03887650|141328767|SUPERIORITY|||||||0.122||||||MME48-72|Wilcoxon (Mann-Whitney)|||||||.122
70919067|NCT03887650|141328767|SUPERIORITY|||||||0.367||||||MME 72-120|Wilcoxon (Mann-Whitney)|||||||.367
70919068|NCT01503749|141328769|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>0.05
70919069|NCT00736853|141328773|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.377||||0.0001|TWO_SIDED|95.0|0.221|0.641|||Log Rank|Stratified Log-rank test with the target disease as the stratification factor||||0.641|0.221|0.0001
70919070|NCT01199705|141328800|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||1.39||||||||1.390||
70919071|NCT01199705|141328800|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||0.953||||||||0.953||
70919072|NCT01199705|141328800|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||0.914||||||||0.914||
70919073|NCT01199705|141328802|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||1.204||||||||1.204||
70919074|NCT01199705|141328802|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||0.834||||||||0.834||
70919075|NCT01199705|141328802|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||0.802||||||||0.802||
70919076|NCT02515305|141328839|EQUIVALENCE|provides 85% power of success|equivalence ratio|97.54|||||TWO_SIDED|90.0|94.6|104.7||No p-value calculated, just a T/R ratio and 90% confidence interval for the bioequivalence analysis|Fieller's method|||||104.7|94.6|
70919077|NCT02515305|141328840|EQUIVALENCE|provides 85% power of success|Equivalence ratio|100.1|||||TWO_SIDED|90.0|96.0|109.3|||Fieller's method|||||109.3|96|
70925905|NCT03637660|141345676|NON_INFERIORITY|The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.|Difference of proportion of participants|-0.06||||0.037|TWO_SIDED|90.0|-0.22|0.09||P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) among HIV-uninfected participants by Farrington-Manning method with a 10% margin.|Farrington-Manning|||The number and proportion of participants with serological response by month 6 among participants without HIV infection and the 95% confidence interval (CI) were summarized overall and by treatment status. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis was that the difference in serological response rate between the three-dose and one-dose groups was at least 10%.||0.09|-0.22|0.037
70925906|NCT03637660|141345677|NON_INFERIORITY|The alternative hypothesis was that the difference in response rates was less than 10%. The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.|Difference of proportion of participants|-0.05||||0.002|TWO_SIDED|90.0|-0.14|0.04||P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) by Farrington-Manning method with a 10% margin.|Farrington-Manning||The 2-sided 90% CI are calculated based on the noninferiority analysis for the -sproportion difference (one-dose group is non-inferior to three-dose group) by Farrington-Manning method with a 10% margin.|The number and proportion of participants with a serological response by Month 12 and the 95% confidence interval (CI) were summarized overall and by treatment. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis was that the difference in serological response rate between the three-dose and one-dose groups was at least 10%.||0.04|-0.14|0.002
71154024|NCT00861705|141800290|SUPERIORITY_OR_OTHER_LEGACY|||||||0.057|||||||Chi-squared|Reported p-values are unadjusted and 1-sided||||||0.057
71093945|NCT04950686|141695690|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.675|TWO_SIDED||||||Mixed Models Analysis|||||||0.675
71093946|NCT04950686|141695690|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.443|TWO_SIDED||||||Mixed Models Analysis|||||||0.443
71093947|NCT04950686|141695691|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.685|TWO_SIDED||||||Mixed Models Analysis|||||||0.685
71093948|NCT04950686|141695691|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.06||0.726|TWO_SIDED||||||Mixed Models Analysis|||||||0.726
70919078|NCT03215927|141328843|SUPERIORITY||Median Difference (Net)|-2.55|STANDARD_ERROR_OF_MEAN|3.34|<|0.05|TWO_SIDED|95.0|-9.36|4.26|||Mixed Models Analysis|Adjustments are for baseline FVC, age, and gender, with a repeated measures effect of participant.|The comparison difference value is µABT - µPlacebo.|The null hypothesis for the change outcomes is µABT - µPlacebo = 0.||4.26|-9.36|<0.05
70919079|NCT03215927|141328844|SUPERIORITY||Hazard Ratio (HR)|0.66|STANDARD_ERROR_OF_MEAN|0.73|<|0.05|TWO_SIDED|95.0|0.16|2.77|||Regression, Cox||ABT is the numerator and Placebo is the denominator for the hazard ratios. The dispersion value given is the SE of the estimate on the natural log scale.|The null hypothesis for the time to event outcomes is exp(bABT) / exp(bPlacebo) = 1.||2.77|0.16|<0.05
70919080|NCT03215927|141328845|SUPERIORITY||Mean Difference (Net)|7.51|STANDARD_ERROR_OF_MEAN|8.12|<|0.05|TWO_SIDED|95.0|-8.8|23.83|||Mixed Models Analysis|Adjustments are for baseline FVC, age, and gender, with a repeated measures effect of participant.|The comparison difference value is µABT - µPlacebo.|The null hypothesis for the change outcomes is µABT - µPlacebo = 0.||23.83|-8.80|<0.05
70919081|NCT03215927|141328846|SUPERIORITY||Hazard Ratio (HR)|0.42|STANDARD_ERROR_OF_MEAN|1.16|<|0.05|TWO_SIDED|95.0|0.04|4.02|||Regression, Cox||ABT is the numerator and Placebo is the denominator for the hazard ratios. The dispersion value given is the SE of the estimate on the natural log scale.|The null hypothesis for the time to event outcomes is exp(bABT) / exp(bPlacebo) = 1.||4.02|0.04|<0.05
70919082|NCT02582593|141328847|SUPERIORITY||Cohen's D|0.27||||0.575|TWO_SIDED|||||t = .581, only 1 comparison (2 groups) and thus multiple comparison correction not needed|t-test, 2 sided|||An independent sample t-test was used to examine difference in Pre-post intervention change scores for the Active and Sham groups;. Cohen's d was calculated to determine effect size.||||.575
70919083|NCT02582593|141328848|SUPERIORITY||Cohen's D|1.06||||0.16|TWO_SIDED|||||t = 1.574; only two comparisons, thus not necessary to adjust|t-test, 2 sided|||independent t-test, cohen's d effect size||||.160
70919084|NCT02582593|141328849|SUPERIORITY||Cohen's D|0.27||||0.424|TWO_SIDED||||||t-test, 2 sided|||independent t-test, Cohen's d effect size||||.424
70919085|NCT02582593|141328850|SUPERIORITY||Cohen's D|-1.03||||0.099|TWO_SIDED|||||no adjustment necessary, only 1 comparison|t-test, 2 sided|||independent sample t-test, Cohen's d effect size||||0.099
70971984|NCT01408147|141450399|SUPERIORITY||Mean Difference (Final Values)|2.3|||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||To test the primary hypothesis, a generalized linear mixed effect model was used (intervention group as a fixed effect and clinic and subject as random effects). A group x time interaction term (fixed effect) tested if the change in weight over time differed significantly. The model included participant-level covariates (i.e., ethnicity, weeks postpartum at study entry, lactation, and age).||||<0.0001
71093949|NCT04950686|141695692|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.04||0.282|TWO_SIDED||||||Mixed Models Analysis|||||||0.282
71093950|NCT04950686|141695692|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.591|TWO_SIDED||||||Mixed Models Analysis|||||||0.591
71154025|NCT00861705|141800294|SUPERIORITY||Cox Proportional Hazard|1.19|||||TWO_SIDED|95.0|0.67|2.1||||||||2.10|0.67|
71154026|NCT00861705|141800294|SUPERIORITY||Cox Proportional Hazard|1.43|||||TWO_SIDED|95.0|0.82|2.47||||||||2.47|0.82|
71154027|NCT00861705|141800294|SUPERIORITY||Cox Proportional Hazard|0.82|||||TWO_SIDED|95.0|0.49|1.37||||||||1.37|0.49|
70919086|NCT03073941|141328854|NON_INFERIORITY|A non-Inferiority analysis was performed once the 1 year OKS of the first 216 patients were collected. A one-sided T-test, 90% power, SD=10 and with a non-inferiority margin of 4 OKS was used and the analysis was based on the difference of average OKS between Persona and NexGen 1 year postoperatively.|||||<|0.05|||||||t-test, 1 sided|90% power, SD=10 and with a non-inferiority margin of 4 OKS||||||<0.05
70919087|NCT04250883|141328864|SUPERIORITY|||||||0.54|||||||Chi-squared, Corrected|for age||||||0.54
70919088|NCT04250883|141328865|SUPERIORITY|||||||0.97|||||||Chi-squared, Corrected|for age||||||0.97
70919089|NCT04250883|141328867|SUPERIORITY|||||||0.64||||||At 12 days postoperative|Chi-squared, Corrected|for age||||||0.64
70919090|NCT04250883|141328867|SUPERIORITY|||||||0.38||||||At 3 months postoperative|Chi-squared, Corrected|for age||||||0.38
70919091|NCT04250883|141328868|SUPERIORITY|||||||0.84|||||||Chi-squared, Corrected|For age||Count of patients with or without pain at 3 months postoperative||||0.84
70919092|NCT04250883|141328868|SUPERIORITY|||||||0.89|||||||ANCOVA|Correction for age||Number of Words Chosen||||0.89
70919093|NCT04250883|141328868|SUPERIORITY|||||||0.98|||||||ANCOVA|Correction for age||Pain Rating index||||0.98
70919094|NCT04250883|141328869|SUPERIORITY|||||||0.9|||||||ANCOVA|Correction for age||||||0.9
71093951|NCT04950686|141695693|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.675|TWO_SIDED||||||Mixed Models Analysis|||||||0.675
71093952|NCT04950686|141695693|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.359|TWO_SIDED||||||Mixed Models Analysis|||||||0.359
71093953|NCT04950686|141695694|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.rt-type scale from 1 (strongly disagree) to 4 (strongly agree); higher scores indicate greater self-efficacy to use a dental dam; range = 1-4|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.685|TWO_SIDED||||||Mixed Models Analysis|||||||0.685
71093954|NCT04950686|141695694|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.198|TWO_SIDED||||||Mixed Models Analysis|||||||0.198
71093955|NCT04950686|141695695|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.-type scale from 1 (strongly disagree) to 4 (strongly agree); higher scores indicate greater self-efficacy to use a dental dam; range = 1-4|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.06||0.46|TWO_SIDED||||||Mixed Models Analysis|||||||0.460
71093956|NCT04950686|141695695|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.822|TWO_SIDED||||||Mixed Models Analysis|||||||0.822
71093957|NCT04950686|141695696|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.06||0.671|TWO_SIDED||||||Mixed Models Analysis|||||||0.671
71093958|NCT04950686|141695696|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.07||0.939|TWO_SIDED||||||Mixed Models Analysis|||||||0.939
71154028|NCT00861705|141800295|SUPERIORITY||Cox Proportional Hazard|1.08|||||TWO_SIDED|95.0|0.66|1.75||||||||1.75|0.66|
71031886|NCT03979079|141572505|OTHER||Hazard Ratio (HR)|0.21|||||TWO_SIDED|95.0|0.14|0.3||Estimation was performed using a Bayesian approach. As such, p-values are not estimated.|Two-stage model.||||Two-stage model within a Bayesian framework to assess the role of the prostate-specific antigens profile on clinical failure while accounting for a secondary treatment prescribed by indication. Prostatespecific antigens modeled using a hierarchical piecewise linear trajectory with a random changepoint. Residual prostate-specific antigens variability was expressed as a function of prostate-specific antigens concentration. Covariates in the survival model included hormone therapy, baseline characteristics, and individual predictions of the prostate-specific antigens nadir and timing and prostate-specific antigens slopes before and after the nadir as provided by the longitudinal process.|0.30|0.14|
71031887|NCT02883452|141572507|NON_INFERIORITY|The non-inferiority of CT-P13 SC to CT-P13 IV was to be concluded if the lower bound of two-sided 90% CI for the ratio of geometric least square means was higher than 80%.|Ratio of Geometric LS means|1154.17|||||TWO_SIDED|90.0|786.37|1694.0|||||The geometric lease square (LS) means, ratio of geometric LS means (CT-P13 SC 120/240 mg to CT-P13 IV 5 mg/kg), and 2-sided 90% CI were obtained from the ANCOVA model.|Primary PK analysis was analyzed using an ANCOVA with treatment as fixed effect and current use of treatment with azathioprine (AZA) or 6-mercaptopurine (6-MP) or methotrexate (MTX) (used or not used), disease (CD or UC), clinical response at Week 6 (responder or non-responder by Clinical Disease Activity Index \[CDAI\]-70 for CD or partial Mayo score for UC), body weight at Week 6 (\<80 kg or ≥80 kg) fitted as covariates.||1694.00|786.37|
71031888|NCT00830206|141572531|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on the pharmacokinetic parameters using SAS® Software.|Geometric Test/Ref Ratio x 100|102.62||||||90.0|94.84|111.05|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111.05|94.84|
71031889|NCT00830206|141572532|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on the pharmacokinetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|100.85||||||90.0|94.48|107.65|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107.65|94.48|
71031890|NCT00830206|141572533|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on the pharmacokimetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|101.92||||||90.0|95.18|109.14|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109.14|95.18|
71031891|NCT01171989|141572538|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: the upper limit of Standardised asymptotic 95% confidence interval lower or equal to 10%|Difference in percentage|0.0|||||TWO_SIDED|95.0|-3.27|2.84||||||Difference in percentage anti-PRP ≥ 0.15 μg/mL||2.84|-3.27|
71031892|NCT01171989|141572539|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: the upper limit of Standardised asymptotic 95% confidence interval lower or equal to 10%|Difference in percentage|0.0|||||TWO_SIDED|95.0|-3.27|2.86||||||Difference between groups for rSBA-MenC ≥1:8||2.86|-3.27|
71031893|NCT01171989|141572539|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: the upper limit of Standardised asymptotic 95% confidence interval lower or equal to 10%|Difference in percentage|0.0|||||TWO_SIDED|95.0|-3.02|2.86||||||Difference between groups for rSBA-MenC ≥1:8||2.86|-3.02|
71154029|NCT00861705|141800295|SUPERIORITY||Cox Proportional Hazard|1.2|||||TWO_SIDED|95.0|0.74|1.92||||||||1.92|0.74|
70971985|NCT01662440|141450401|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of accelerated schedule of the Rabies vaccine considered non-inferior to the conventional schedule if the lower bound of the two-sided 97.5% Confidence Intervals (CI) of the difference in the percentages of subjects with RVNA titer ≥0.5 IU/mL measured 7 days after last active vaccination is greater than -5.|Difference in percentages of subjects|0.0|||||TWO_SIDED|97.5|-2.8|2.8||||||To establish non-inferiority of the immune response of Rabies vaccine (administered concomitantly with JE vaccine) accelerated schedule as compared to conventional schedule at 7 days after last active vaccination.||2.8|-2.8|
70971986|NCT01662440|141450402|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of accelerated schedule of the JE vaccine is considered non-inferior to the conventional schedule if the lower bound of the two-sided 97.5% CI of the difference in the percentages of subjects with PRNT50 titer ≥1:10 measured 28 days after last active vaccination is greater than -10.|Difference in percentages of subjects|-1.0|||||TWO_SIDED|97.5|-4.8|7.9||||||Non-inferiority of the immune response of JE vaccine (administered concomitantly with Rabies vaccine) accelerated schedule as compared to conventional schedule at 28 day after last active vaccination||7.9|-4.8|
70971987|NCT01662440|141450403|NON_INFERIORITY_OR_EQUIVALENCE|The conventional schedule of Rabies vaccine co-administered with JE vaccine considered non inferior to the conventional schedule of Rabies vaccine administered alone if the lower bound of the two-sided 95% CI of the ratio of GMCs measured 28 days after last active vaccination is greater than 0.667.|Between groups ratio of GMCs|1.07|||||TWO_SIDED|95.0|0.86|1.32||||||Non-inferiority of the immune response of Rabies vaccine (administered concomitantly with JE vaccine) as compared to Rabies vaccines (administered alone) as given according to conventional schedule at 28day after last active vaccination||1.32|0.86|
70971988|NCT01662440|141450404|NON_INFERIORITY_OR_EQUIVALENCE|The conventional schedule of JE vaccine co-administered with Rabies vaccine considered non inferior to the conventional schedule of JE vaccine administered alone if the lower bound of the two-sided 95% CI of the ratio of GMTs measured 28 days after last active vaccination is greater than 0.5.|Ratio of GMTs|0.88|||||TWO_SIDED|95.0|0.68|1.13||||||Non-inferiority of the immune response of JE vaccine (administered concomitantly with Rabies vaccine) as compared to JE vaccine (administered alone) as given according to conventional schedule at day 28 after last active vaccination.||1.13|0.68|
70971989|NCT01662440|141450405|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of accelerated schedule of the Rabies vaccine is considered non-inferior to the Rabies vaccine conventional schedule if the lower bound of the two-sided 95% CI of the difference in the percentages of subjects with RVNA titer ≥0.5 IU/mL measured 28 days after last active vaccine administration is greater than -5.|Difference in percentages of subjects|-1.0|||||TWO_SIDED|95.0|-3.8|1.4||||||Non-inferiority of the Rabies immune response (administered concomitantly with JE vaccine) as given according to an accelerated schedule as compared Rabies vaccine (administered alone) as given to a conventional schedule at day 28 after last active vaccination||1.4|-3.8|
70971990|NCT01662440|141450406|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of accelerated schedule of the JE vaccine considered non-inferior to the conventional schedule if the lower bound of the two-sided 95% CI of the difference in the percentages of subjects with PRNT50 titer ≥1:10 measured 7 days after last active vaccine administration is greater than -10.|Difference in percentages of subjects|-1.0|||||TWO_SIDED|95.0|-4.1|6.2||||||Non-inferiority of the immune response of JE vaccine (administered concomitantly with Rabies vaccine) as given according to an accelerated schedule as compared to JE vaccine (administered alone) as given according to a conventional schedule at 7day after last active vaccine administration.||6.2|-4.1|
70971991|NCT02600507|141450420|SUPERIORITY||Least Squares Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.03||0.021|TWO_SIDED|95.0|-4.42|-0.37|||Mixed Effects Model for Repeated Measure|||||-0.37|-4.42|0.021
70971992|NCT02600507|141450420|SUPERIORITY||Least Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|1.01||0.099|TWO_SIDED|95.0|-3.65|0.32|||Mixed Effects Model for Repeated Measure|||||0.32|-3.65|0.099
70971993|NCT02600507|141450421|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.008|TWO_SIDED|95.0|-0.59|-0.09|||Mixed Effects Model for Repeated Measure|||||-0.09|-0.59|0.008
71093959|NCT04950686|141695697|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.655|TWO_SIDED||||||Mixed Models Analysis|||||||0.655
70971994|NCT02600507|141450421|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.04|TWO_SIDED|95.0|-0.5|-0.01|||Mixed Effects Model for Repeated Measure|||||-0.01|-0.50|0.040
70971995|NCT05048719|141450434|SUPERIORITY||LS Mean Difference|-0.77|||<|0.001|TWO_SIDED|95.0|-1.13|-0.4|||Mixed Models Analysis|||||-0.40|-1.13|<0.001
70971996|NCT05048719|141450434|SUPERIORITY||LS Mean Difference|-1.49|||<|0.001|TWO_SIDED|95.0|-1.85|-1.12|||Mixed Models Analysis|||||-1.12|-1.85|<0.001
70971997|NCT05048719|141450434|SUPERIORITY||LS Mean Difference|-1.36|||<|0.001|TWO_SIDED|95.0|-1.75|-0.98|||Mixed Models Analysis|||||-0.98|-1.75|<0.001
70971998|NCT05048719|141450434|SUPERIORITY||LS Mean Difference|-1.6|||<|0.001|TWO_SIDED|95.0|-1.96|-1.25|||Mixed Models Analysis|||||-1.25|-1.96|<0.001
70971999|NCT05048719|141450434|SUPERIORITY||LS Mean Difference|-1.67|||<|0.001|TWO_SIDED|95.0|-2.02|-1.32|||Mixed Models Analysis|||||-1.32|-2.02|<0.001
71093960|NCT04950686|141695697|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.07||0.315|TWO_SIDED||||||Mixed Models Analysis|||||||0.315
70972000|NCT05048719|141450435|SUPERIORITY||LS Mean Difference|-0.09||||0.626|TWO_SIDED|95.0|-0.47|0.28|||Mixed Models Analysis|||||0.28|-0.47|0.626
70972001|NCT05048719|141450435|SUPERIORITY||LS Mean Difference|-0.81|||<|0.001|TWO_SIDED|95.0|-1.18|-0.44|||Mixed Models Analysis|||||-0.44|-1.18|<0.001
70972002|NCT05048719|141450435|SUPERIORITY||LS Mean Difference|-0.69|||<|0.001|TWO_SIDED|95.0|-1.08|-0.3|||Mixed Models Analysis|||||-0.30|-1.08|<0.001
70972003|NCT05048719|141450435|SUPERIORITY||LS Mean Difference|-0.93|||<|0.001|TWO_SIDED|95.0|-1.29|-0.57|||Mixed Models Analysis|||||-0.57|-1.29|<0.001
70972004|NCT05048719|141450435|SUPERIORITY||LS Mean Difference|-1.0|||<|0.001|TWO_SIDED|95.0|-1.36|-0.64|||Mixed Models Analysis|||||-0.64|-1.36|<0.001
70972005|NCT05048719|141450436|OTHER||Odds Ratio (OR)|6.77|||<|0.001|TWO_SIDED|95.0|2.21|20.75|||Regression, Logistic|||||20.75|2.21|<0.001
71093961|NCT04950686|141695698|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.002|STANDARD_ERROR_OF_MEAN|0.04||0.966|TWO_SIDED||||||Mixed Models Analysis|||||||0.966
71154030|NCT00861705|141800295|SUPERIORITY||Cox Proportional Hazard|0.82|||||TWO_SIDED|95.0|0.49|1.37||||||||1.37|0.49|
70919095|NCT04250883|141328870|SUPERIORITY|||||||0.68|||||||ANCOVA|Correction for age||At 1 hour||||0.68
70919096|NCT04250883|141328870|SUPERIORITY|||||||0.91|||||||ANCOVA|Correction for age||At 6 hours||||0.91
70919097|NCT04250883|141328870|SUPERIORITY|||||||0.73|||||||ANCOVA|Correction for age||||||0.73
70919098|NCT04250883|141328870|SUPERIORITY|||||||0.77|||||||ANCOVA|Correction for age||||||0.77
70919099|NCT04250883|141328871|SUPERIORITY|||||||0.63|||||||ANCOVA|Correction for age||At 1 hour||||0.63
70919100|NCT04250883|141328871|SUPERIORITY|||||||0.19|||||||ANCOVA|Correction for age||At postoperative day 1||||0.19
70919101|NCT04250883|141328872|SUPERIORITY|||||||0.89|||||||ANCOVA|Correction for age||At 1 hour||||0.89
70919102|NCT04250883|141328872|SUPERIORITY|||||||0.49|||||||ANCOVA|Correction for age||At postoperative day 1||||0.49
70919103|NCT04250883|141328873|SUPERIORITY|||||||0.42|||||||ANCOVA|Correction for age||||||0.42
70919104|NCT04250883|141328874|SUPERIORITY|||||||0.92|||||||ANCOVA|Correction for age||Of Total complications within 30 days postoperative||||0.92
70919105|NCT04250883|141328875|SUPERIORITY|||||||0.098|||||||ANCOVA|correction for age||Time to maximal intensity||||0.098
71093962|NCT04950686|141695698|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.708|TWO_SIDED||||||Mixed Models Analysis|||||||0.708
70919106|NCT04250883|141328875|SUPERIORITY|||||||0.008|||||||ANCOVA|correction for age||Angle from minimal to maximal intensity||||0.008
70919107|NCT04250883|141328875|SUPERIORITY|||||||0.042|||||||ANCOVA|correction for age||Delta between minimal and maximal intensity||||0.042
70919108|NCT04250883|141328876|SUPERIORITY|||||||0.35|||||||ANCOVA|Correction for age||postoperative day 1||||0.35
70919109|NCT04250883|141328876|SUPERIORITY|||||||0.52|||||||ANCOVA|Correction for age||at postoperative day 12||||0.52
70919110|NCT04250883|141328877|SUPERIORITY|||||||0.99|||||||ANCOVA|correction for age||at postoperative day 1||||0.99
70919111|NCT04250883|141328877|SUPERIORITY|||||||0.3|||||||ANCOVA|Correction for age||At postoperative day 12||||0.30
70919112|NCT04250883|141328878|SUPERIORITY|||||||0.42|||||||ANCOVA|Correction for age||||||0.42
71154031|NCT00861705|141800296|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.66|2.03||||||||2.03|0.66|
71154032|NCT00861705|141800296|SUPERIORITY||Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|0.72|2.16||||||||2.16|0.72|
70919113|NCT04250883|141328879|SUPERIORITY|||||||0.3|||||||ANCOVA|Correction for age||||||0.3
70919114|NCT04250883|141328880|SUPERIORITY|||||||0.33|||||||ANCOVA|Correction for age||||||0.33
70919115|NCT04250883|141328881|SUPERIORITY|||||||0.018|||||||ANCOVA|Correction for age||||||0.018
70919116|NCT04425629|141328898|SUPERIORITY||LS Mean|-0.33|STANDARD_ERROR_OF_MEAN|0.1|=|0.0006|TWO_SIDED|95.0|-0.52|-0.14|||ANCOVA|||||-0.14|-0.52|= 0.0006
70919117|NCT04425629|141328898|SUPERIORITY||LS Mean|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.56|-0.19|||ANCOVA|||||-0.19|-0.56|< 0.0001
70919118|NCT04425629|141328899|SUPERIORITY||||||=|0.0024|||||||Cochran-Mantel-Haenszel|||||||= 0.0024
70919119|NCT04425629|141328900|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||< 0.0001
70919120|NCT04425629|141328906|SUPERIORITY||||||=|0.1903|||||||Mixed Models Analysis|||||||= 0.1903
70919121|NCT04425629|141328906|SUPERIORITY||||||=|0.8431|||||||Mixed Models Analysis|||||||= 0.8431
70919122|NCT04425629|141328962|SUPERIORITY||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.06|16.12||||||||16.12|0.06|
70919123|NCT04425629|141328963|SUPERIORITY||Hazard Ratio (HR)|0.33|||||TWO_SIDED|95.0|0.03|3.13||||||||3.13|0.03|
70919124|NCT03538717|141328990|SUPERIORITY|||||||0.113|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.113
70919125|NCT03538717|141328991|SUPERIORITY|||||||0.228|||||||Fisher Exact|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.228
70919126|NCT03538717|141328992|SUPERIORITY|||||||0.02|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.020
70919127|NCT03538717|141328993|SUPERIORITY|||||||0.138|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.138
70919128|NCT03538717|141328994|SUPERIORITY|||||||0.524|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.524
70919129|NCT03538717|141328995|SUPERIORITY|||||||0.265|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.265
70919130|NCT03538717|141328996|SUPERIORITY|||||||0.035|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.035
70919131|NCT03538717|141328997|SUPERIORITY|||||||0.123|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.123
70919132|NCT03538717|141328998|SUPERIORITY|||||||0.327|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.327
70919133|NCT03538717|141328999|SUPERIORITY|||||||0.419|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.419
70919134|NCT03538717|141329000|SUPERIORITY|||||||0.01|||||||Fisher Exact|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.010
70919135|NCT03538717|141329001|SUPERIORITY|||||||0.446|||||||Chi-squared|||100% clear cells||||0.446
70972006|NCT05048719|141450436|OTHER||Odds Ratio (OR)|34.09|||<|0.001|TWO_SIDED|95.0|9.92|117.16|||Regression, Logistic|||||117.16|9.92|<0.001
70972007|NCT05048719|141450436|OTHER||Odds Ratio (OR)|48.33|||<|0.001|TWO_SIDED|95.0|11.9|196.24|||Regression, Logistic|||||196.24|11.90|<0.001
70972008|NCT05048719|141450436|OTHER||Odds Ratio (OR)|45.72|||<|0.001|TWO_SIDED|95.0|13.61|153.64|||Regression, Logistic|||||153.64|13.61|<0.001
71093963|NCT04950686|141695699|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.006|STANDARD_ERROR_OF_MEAN|0.04||0.887|TWO_SIDED||||||Mixed Models Analysis|||||||0.887
70972009|NCT05048719|141450436|OTHER||Odds Ratio (OR)|77.23|||<|0.001|TWO_SIDED|95.0|20.26|294.48|||Regression, Logistic|||||294.48|20.26|<0.001
71093964|NCT04950686|141695699|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.077|TWO_SIDED||||||Mixed Models Analysis|||||||0.077
70972010|NCT05048719|141450436|OTHER||Odds Ratio (OR)|1.22||||0.678|TWO_SIDED|95.0|0.48|3.13|||Regression, Logistic|||||3.13|0.48|0.678
70972011|NCT05048719|141450436|OTHER||Odds Ratio (OR)|6.15|||<|0.001|TWO_SIDED|95.0|2.19|17.24|||Regression, Logistic|||||17.24|2.19|<0.001
70972012|NCT05048719|141450436|OTHER||Odds Ratio (OR)|8.71|||<|0.001|TWO_SIDED|95.0|2.55|29.79|||Regression, Logistic|||||29.79|2.55|<0.001
70972013|NCT05048719|141450436|OTHER||Odds Ratio (OR)|8.24|||<|0.001|TWO_SIDED|95.0|3.05|22.3|||Regression, Logistic|||||22.30|3.05|<0.001
71031894|NCT01015625|141572581|SUPERIORITY|A two-sided significance level of 5% was used.|Cox Proportional Hazard|1.77||||0.042|TWO_SIDED|95.0|1.01|3.09|||Log Rank||From the Cox Proportional hazard model with surgery vs no surgery fitted as a covariate. A hazard ratio \> 1.0 indicates a higher average event rate and a shorter overall survival time for surgery relative to no surgery.|To determine the effect of local therapy (surgery, Arm A) compared to systemic therapy only (Arm B) in synchronous metastasized breast cancer patients in terms of overall survival. Overall survival is defined as the time from randomization to death from any cause. Participants last known to be alive were censored at their last contact date or at the data cut-off date whichever came first.||3.09|1.01|0.042
71093965|NCT04950686|141695700|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.217|TWO_SIDED||||||Mixed Models Analysis|||||||0.217
71093966|NCT04950686|141695700|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.879|TWO_SIDED||||||Mixed Models Analysis|||||||0.879
71093967|NCT04950686|141695701|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.866|TWO_SIDED||||||Mixed Models Analysis|||||||0.866
71093968|NCT04950686|141695701|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.06||0.695|TWO_SIDED||||||Mixed Models Analysis|||||||0.695
71093969|NCT04950686|141695702|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.004|STANDARD_ERROR_OF_MEAN|0.06||0.94|TWO_SIDED||||||Mixed Models Analysis|||||||0.940
71093970|NCT04950686|141695702|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.06||0.451|TWO_SIDED||||||Mixed Models Analysis|||||||0.451
71093971|NCT04950686|141695703|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.06||0.442|TWO_SIDED||||||Mixed Models Analysis|||||||0.442
71093972|NCT04950686|141695703|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.082|TWO_SIDED||||||Mixed Models Analysis|||||||0.082
71093973|NCT04950686|141695704|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.06||0.236|TWO_SIDED||||||Mixed Models Analysis|||||||0.236
71093974|NCT04950686|141695704|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.08||0.674|TWO_SIDED||||||Mixed Models Analysis|||||||0.674
71093975|NCT04950686|141695705|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.08||0.135|TWO_SIDED||||||Mixed Models Analysis|||||||0.135
71154033|NCT00861705|141800296|SUPERIORITY||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.53|1.7||||||||1.70|0.53|
71093976|NCT04950686|141695705|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.08||0.5|TWO_SIDED||||||Mixed Models Analysis|||||||0.500
71093977|NCT04950686|141695706|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.005|STANDARD_ERROR_OF_MEAN|0.09||0.956|TWO_SIDED||||||Mixed Models Analysis|||||||0.956
71154034|NCT03653507|141800302|SUPERIORITY||Hazard Ratio (HR)|0.689||||0.0005|TWO_SIDED|95.0|0.552|0.86|||Log Rank||Log-rank test stratified by:\* Region (Asia vs Non-Asia), \* Number of organs with metastatic sites (0 to 2 vs \>= 3), \* Prior gastrectomy (Yes or No)|||0.860|0.552|0.0005
70919136|NCT03538717|141329001|SUPERIORITY|||||||0.596|||||||Chi-squared|||100% non-clear cells||||0.596
70919137|NCT03538717|141329001|SUPERIORITY|||||||0.578|||||||Chi-squared|||Majority component of clear cells||||0.578
70919138|NCT03538717|141329001|SUPERIORITY|||||||0.706|||||||Fisher Exact|||Majority component of non-clear cells||||0.706
70919139|NCT03538717|141329002|SUPERIORITY|||||||0.074|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.074
70919140|NCT03538717|141329003|SUPERIORITY|||||||0.07|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.070
70919141|NCT03538717|141329004|SUPERIORITY|||||||0.091|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.091
70919142|NCT03538717|141329005|SUPERIORITY|||||||0.046|||||||Chi-squared|||Lymph nodes||||0.046
70919143|NCT03538717|141329005|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||CNS||||>0.999
70919144|NCT03538717|141329005|SUPERIORITY|||||||0.026|||||||Chi-squared|||Hepatic||||0.026
70919145|NCT03538717|141329005|SUPERIORITY|||||||0.327|||||||Chi-squared|||Pulmonary||||0.327
70919146|NCT03538717|141329005|SUPERIORITY|||||||0.024|||||||Chi-squared|||Bone||||0.024
70919147|NCT03538717|141329005|SUPERIORITY|||||||0.045|||||||Chi-squared|||Another site of metastasis||||0.045
70919148|NCT03538717|141329006|SUPERIORITY|||||||0.555|||||||Chi-squared|||LDH level \>1.5\*ULN||||0.555
70919149|NCT03538717|141329006|SUPERIORITY||||||<|0.001|||||||Chi-squared|||Hgb levels \<=LLN||||<0.001
70919150|NCT03538717|141329006|SUPERIORITY|||||||0.344|||||||Chi-squared|||Corrected Ca levels \>10 mg/dL||||0.344
70919151|NCT03538717|141329006|SUPERIORITY||||||>|0.999|||||||Chi-squared|||Neutrophil levels \>ULN||||>0.999
70919152|NCT03538717|141329006|SUPERIORITY|||||||0.795|||||||Chi-squared|||Platelet levels \>ULN||||0.795
70919153|NCT03538717|141329006|SUPERIORITY|||||||0.184|||||||Chi-squared|||Neutrophil-to-lymphocyte ratio \<=3||||0.184
70919154|NCT03538717|141329007|SUPERIORITY|||||||0.235|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.235
70919155|NCT02918279|141329032|SUPERIORITY||Treatment difference|-0.22||||0.0022|TWO_SIDED|95.0|-0.37|-0.08|||ANCOVA||Liraglutide 3.0 mg - Placebo|Analysis of in-trial data with missing observations was imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Responses at week 56 were analysed using an analysis of covariance model with treatment, sex, region, baseline glycaemic category, stratification factor for Tanner stage and interaction between baseline glycaemic category and stratification factor for Tanner stage as fixed effects, baseline BMI SDS, age as covariates.||-0.08|-0.37|0.0022
70919156|NCT02706717|141329102|SUPERIORITY||Mean Difference (Net)|-51.3||||0.6|TWO_SIDED|95.0|-246.0|143.9|||t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Visbiome ES mean minus placebo mean.|||143.9|-246|0.60
70919157|NCT02706717|141329108|SUPERIORITY||Mean Difference (Net)|0.042||||0.51|TWO_SIDED|95.0|-0.09|0.17|||t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Visbiome ES mean minus placebo mean.|||0.17|-0.09|0.51
70919158|NCT02706717|141329109|SUPERIORITY||Mean Difference (Net)|28.4||||0.09|TWO_SIDED|95.0|-3.6|71.0|||t-test, 2 sided|2-sample t-test with equal variance|"The estimation parameter is the percent difference between the geometric mean fold changes.~With d-dimer data log10 transformed, this is (exp(Visbiome ES mean minus placebo mean) - 1)\*100."|||71.0|-3.6|0.09
70919159|NCT02706717|141329112|SUPERIORITY||Mean Difference (Net)|-32.7||||0.29|TWO_SIDED|95.0|-93.5|28.2|||t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Visbiome ES mean minus placebo mean.|||28.2|-93.5|0.29
70919160|NCT02706717|141329113|SUPERIORITY||Mean Difference (Net)|-0.02||||0.41|TWO_SIDED|95.0|-0.08|0.04|||t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Visbiome ES mean minus placebo mean.|||0.04|-0.08|0.41
70919161|NCT02706717|141329130|SUPERIORITY|||||||0.15|||||||Kruskal-Wallis|||||||0.15
70919162|NCT01911169|141329132|OTHER||Cohen's d|0.68|||||TWO_SIDED|||||||||Effect size of primary outcome was calculated||||
70919163|NCT01911169|141329132|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||This study was conducted to determine the effect size for in change in FMD at 16 weeks with 25(OH) therapy. For change in FMD at 16 weeks with 25(OH)D repletion, based on this effect size, to detect significant differences between 2 groups, assuming 1) normally distributed data, 2) the same effect size, 3) alpha= 0.05, and 4) a power of 0.8, 35 patients in each group would be required. Therefore, this was designed as a pilot to determine effect size.||||> 0.05
70919164|NCT02512965|141329134|SUPERIORITY||Odds Ratio (OR)|3.46||||0.0002|TWO_SIDED|95.0|1.79|6.69||2-sided, adjusted for stratification factors at randomization.|Cochran-Mantel-Haenszel||Mantel-Haenszel estimate stratified by stratification factor at randomization.|||6.69|1.79|0.0002
70919165|NCT02512965|141329135|SUPERIORITY||Odds Ratio (OR)|2.56||||0.0036|TWO_SIDED|95.0|1.35|4.85|||Cochran-Mantel-Haenszel||Mantel-Haenszel estimate stratified by stratification factors at randomization.|||4.85|1.35|0.0036
70919166|NCT02512965|141329136|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.26|TWO_SIDED|95.0|0.46|1.24|||Log Rank|2-sided p-value adjusted for stratification factors at randomization.|Estimate adjusted for stratification factors at randopmization.|||1.24|0.46|0.26
70919167|NCT02512965|141329137|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.47|TWO_SIDED|95.0|0.48|1.4||2-sided p-value adjusted for stratification factors at randomization.|Log Rank|||||1.40|0.48|0.47
71093978|NCT04950686|141695706|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.09||0.214|TWO_SIDED||||||Mixed Models Analysis|||||||0.214
71154035|NCT03653507|141800303|SUPERIORITY||Hazard Ratio (HR)|0.763||||0.0047|TWO_SIDED|95.0|0.622|0.936|||Log Rank||Log-rank test stratified by:\* Region (Asia vs Non-Asia), \* Number of organs with metastatic sites (0 to 2 vs \>= 3), \* Prior gastrectomy (Yes or No)|||0.936|0.622|0.0047
70919168|NCT01185782|141329161|NON_INFERIORITY_OR_EQUIVALENCE|"The primary endpoint was to determine whether or not SJ-0021 is inferior to u-hFSH in inducing ovulation. The criterion for non-inferiority was that the lower limit of the two-sided 95% CI (= one-sided 97.5% CI) had to be greater than -15% for SJ-0021 to be considered not inferior to u-hFSH.)"|Delta|-3.51|||||TWO_SIDED|95.0|-13.05|6.04|||Chi-squared|||||6.04|-13.05|
70919169|NCT01185782|141329162|SUPERIORITY_OR_OTHER|||||||0.214||95.0|||||Chi-squared|||||||0.214
70919170|NCT01185782|141329163|SUPERIORITY_OR_OTHER|||||||0.087||95.0|||||t-test, 2 sided|||||||0.087
70919171|NCT01185782|141329164|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||t-test, 2 sided|||||||0.069
70919172|NCT01185782|141329165|SUPERIORITY_OR_OTHER|||||||0.852||95.0|||||Chi-squared|||||||0.852
70919173|NCT01185782|141329166|SUPERIORITY_OR_OTHER|||||||0.102||95.0|||||Chi-squared|||||||0.102
70919174|NCT01185782|141329167|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Chi-squared|||||||0.560
70919175|NCT01185782|141329168|SUPERIORITY_OR_OTHER|||||||0.555||95.0|||||Chi-squared|||||||0.555
70919176|NCT01185782|141329169|SUPERIORITY_OR_OTHER|||||||0.416||95.0|||||Chi-squared|||||||0.416
70919177|NCT02507752|141329173|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Physical component score at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA).||||< 0.001
70919178|NCT02507752|141329173|SUPERIORITY_OR_OTHER||||||=|0.014|TWO_SIDED||||||ANOVA|||Mental component score at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA).||||= 0.014
70919179|NCT02507752|141329175|SUPERIORITY_OR_OTHER||||||=|0.021|TWO_SIDED||||||ANOVA|||Mean change from Baseline in ESR at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.021
71093979|NCT04950686|141695707|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.06||0.337|TWO_SIDED||||||Mixed Models Analysis|||||||0.337
71093980|NCT04950686|141695707|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.004|STANDARD_ERROR_OF_MEAN|0.07||0.957|TWO_SIDED||||||Mixed Models Analysis|||||||0.957
70919180|NCT02507752|141329175|SUPERIORITY_OR_OTHER||||||=|0.003|TWO_SIDED||||||ANOVA|||Mean change from Baseline in ESR at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.003
70919181|NCT02507752|141329176|SUPERIORITY_OR_OTHER||||||=|0.744|TWO_SIDED||||||ANOVA|||Mean change from Baseline in CRP at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.744
70919182|NCT02507752|141329176|SUPERIORITY_OR_OTHER||||||=|0.646|TWO_SIDED||||||ANOVA|||Mean change from Baseline in CRP at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.646
70919183|NCT02507752|141329177|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in SJC at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
70919184|NCT02507752|141329177|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in SJC at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
70919185|NCT02507752|141329178|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in TJC at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
70919186|NCT02507752|141329178|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in TJC at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
70919187|NCT02507752|141329179|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in DAS28 at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
70919188|NCT02507752|141329179|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in DAS28 at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
70919189|NCT02507752|141329180|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in patient global assessment at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
70919190|NCT02507752|141329180|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in patient global assessment at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
70919191|NCT02507752|141329181|SUPERIORITY_OR_OTHER||||||=|0.011|TWO_SIDED||||||ANOVA|||Change in HAQ score from screening to Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.011
70919192|NCT02507752|141329181|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||ANOVA|||Change in HAQ score from screening to Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.001
70919193|NCT02507752|141329182|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change in pain scale from screening to Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
70919194|NCT02507752|141329182|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change in pain scale from screening to Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
70919195|NCT02507752|141329183|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||ANOVA|||Physical component score at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.001
70919196|NCT02507752|141329183|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||ANOVA|||Mental component score at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.001
70919197|NCT02507752|141329184|SUPERIORITY_OR_OTHER||||||=|0.102|TWO_SIDED||||||ANOVA|||Physical functioning domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.102
70919198|NCT02507752|141329184|SUPERIORITY_OR_OTHER||||||=|0.008|TWO_SIDED||||||ANOVA|||Physical functioning domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.008
70919199|NCT02507752|141329184|SUPERIORITY_OR_OTHER||||||=|0.008|TWO_SIDED||||||ANOVA|||Role physical domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.008
70919200|NCT02507752|141329184|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Role physical domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
70919201|NCT02507752|141329184|SUPERIORITY_OR_OTHER||||||=|0.002|TWO_SIDED||||||ANOVA|||Bodily pain domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.002
70919202|NCT02507752|141329184|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Bodily pain domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
70919203|NCT02507752|141329184|SUPERIORITY_OR_OTHER||||||=|0.077|TWO_SIDED||||||ANOVA|||General health domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.077
70919204|NCT02507752|141329184|SUPERIORITY_OR_OTHER||||||=|0.068|TWO_SIDED||||||ANOVA|||General health domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.068
70919205|NCT02507752|141329184|SUPERIORITY_OR_OTHER||||||=|0.018|TWO_SIDED||||||ANOVA|||Vitality domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.018
70919206|NCT02507752|141329184|SUPERIORITY_OR_OTHER||||||=|0.053|TWO_SIDED||||||ANOVA|||Vitality domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.053
70919207|NCT02507752|141329184|SUPERIORITY_OR_OTHER||||||=|0.002|TWO_SIDED||||||ANOVA|||Social functioning domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.002
70919208|NCT02507752|141329184|SUPERIORITY_OR_OTHER||||||=|0.003|TWO_SIDED||||||ANOVA|||Social functioning domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.003
70919209|NCT02507752|141329184|SUPERIORITY_OR_OTHER||||||=|0.015|TWO_SIDED||||||ANOVA|||Role emotional domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.015
70919210|NCT02507752|141329184|SUPERIORITY_OR_OTHER||||||=|0.154|TWO_SIDED||||||ANOVA|||Role emotional domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.154
70919211|NCT02507752|141329184|SUPERIORITY_OR_OTHER||||||=|0.024|TWO_SIDED||||||ANOVA|||Mental health domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.024
70919212|NCT02507752|141329184|SUPERIORITY_OR_OTHER||||||=|0.029|TWO_SIDED||||||ANOVA|||Mental health domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.029
70919213|NCT01061151|141329188|SUPERIORITY||Risk Difference (RD)|-1.3|||||TWO_SIDED|96.5|-2.1|-0.4|||||The combination of Arm B and Arm C minus Arm A, based on a repeated confidence interval (Lan-DeMets approach with an O'Brien-Fleming type I error spending function to preserve an experiment-wise type I error rate of 5%).|Arm B and Arm C were combined and compared to Arm A. This comparison was an a priori planned comparison.||-0.4|-2.1|
70919214|NCT01061151|141329189|SUPERIORITY|||||||0.008|||||||Fisher Exact|||Periods 1 and 2||||0.008
70919215|NCT01061151|141329189|SUPERIORITY|||||||0.77|||||||Fisher Exact|||Period 2||||0.77
70919216|NCT01061151|141329189|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||Period 2||||>0.99
70919217|NCT01061151|141329190|SUPERIORITY|||||||0.3|||||||Fisher Exact|||Periods 1 and 2||||0.30
70919218|NCT01061151|141329190|SUPERIORITY|||||||0.64|||||||Fisher Exact|||Period 2||||0.64
70919219|NCT01061151|141329190|SUPERIORITY|||||||0.06|||||||Fisher Exact|||Period 2||||0.06
70919220|NCT01061151|141329191|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||Periods 1 and 2||||<0.001
70919221|NCT01061151|141329191|SUPERIORITY|||||||0.04|||||||Fisher Exact|||Period 2||||0.04
70919222|NCT01061151|141329191|SUPERIORITY|||||||0.46|||||||Fisher Exact|||Period 2||||0.46
70919223|NCT01061151|141329192|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|96.0|0.3|3.1|||||The confidence interval was based on a repeated confidence interval.|||3.1|0.3|
70919224|NCT01061151|141329193|SUPERIORITY|||||||0.98|||||||Log Rank|||||||0.98
70919225|NCT01061151|141329194|SUPERIORITY||Hazard Ratio (HR)|0.55||||0.37|TWO_SIDED|95.0|0.14|2.08|||Log Rank||The hazard ratio compares Arm A relative to Arm B.|||2.08|0.14|0.37
70919226|NCT01061151|141329196|SUPERIORITY|||||||0.16|||||||Two-sided Z test|||Overall survival||||0.16
70919227|NCT01061151|141329196|SUPERIORITY|||||||0.0156|||||||Two-sided Z test|||Overall survival, period 2 group||||0.0156
70919228|NCT01061151|141329196|SUPERIORITY|||||||0.31|||||||Two-sided Z test|||Overall survival, period 2 group||||0.31
70919229|NCT01061151|141329196|SUPERIORITY|||||||0.0022|||||||Two-sided Z test|||Overall survival, period 2 group||||0.0022
70919230|NCT01061151|141329196|SUPERIORITY|||||||0.13|||||||Two-sided Z test|||HIV-free survival||||0.13
70919231|NCT01061151|141329196|SUPERIORITY|||||||0.44|||||||Two-sided Z test|||HIV-free survival, period 2 group||||0.44
70919232|NCT01061151|141329196|SUPERIORITY|||||||0.24|||||||Two-sided Z test|||HIV-free survival, period 2 group||||0.24
70919233|NCT01061151|141329196|SUPERIORITY|||||||0.26|||||||Two-sided Z test|||HIV-free survival, group 2||||0.26
70919234|NCT03740009|141329225|NON_INFERIORITY|For analyses the researchers used a paired T-test to compare baseline and post-treatment mean activation values across 3 regions of interest (ROIs): the caudate, putamen and nucleus accumbens.||||||0.53|||||||t-test, 2 sided|||\[Ho\]: TSEC has no meaningful effect on activity within key nodes of the frontostriate in response to reward.||||0.53
70919235|NCT03740009|141329226|NON_INFERIORITY|Analysis included MASQ-AD scores from all visits to characterize the change in scores from baseline to post-treatment.|GLM|-5.8|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|||||Mixed models of 3 week TSEC administration for MASQ-AD scores assessed at each study visit from baseline to post-treatment.|GLM||F value=13.26|\[Ho\] No change in depressive symptoms from baseline throughout 3 weeks of TSEC administration||||<0.001
70919236|NCT03926039|141329227|EQUIVALENCE|Equivalence Analysis||||||0.05|||||||ANOVA|||Both group of average difference (95% CI) in intervention group and control group||||0.05
70919237|NCT00933400|141329285|EQUIVALENCE|equivalence margin = 0|Percent Difference|0.02|||||TWO_SIDED|95.0|-5.6|5.7||||||Difference in AMI rate. NULL: equal rates of AMI in both Groups.||5.7|-5.6|
70919238|NCT00933400|141329286|EQUIVALENCE|equivalence margin = 0|Difference (rates)|26.8|||||TWO_SIDED|95.0|21.4|32.2||||||Difference in Discharge rates. H0: equal rates of Discharge in both Groups.||32.2|21.4|
70919239|NCT00933400|141329286|EQUIVALENCE|equivalence margin = 0|Difference (percents)|5.6|||||TWO_SIDED|95.0|0.0|11.2|||||exact procedures were used to estimate and compare rates of detection for significant coronary disease|Difference in diagnosis rate of Significant coronary disease at index visit. H0: equal rates in both Groups.||11.2|0.0|
70919240|NCT00933400|141329288|SUPERIORITY||binomial proportion|26.8|||||TWO_SIDED|95.0|21.4|32.2|||||Exact confidence intervals for the difference in proportions|H0: no difference in Patient disposition (Discharge) rates between arms||32.2|21.4|
70919241|NCT00933400|141329290|EQUIVALENCE|The trial was powered to test the principal hypothesis that the major adverse cardiac event (MACE, including myocardial infarction and cardiac death) rate among patients found not to have significant CAD on CCTA exceeds 1%|binomial proportion|-0.4|||||TWO_SIDED|95.0|-6.0|5.2|||||Exact confidence intervals for the difference in proportions|Compare all cause mortality between groups||5.2|-6.0|
70919242|NCT00933400|141329290|EQUIVALENCE|The trial was powered to test the principal hypothesis that the major adverse cardiac event (MACE, including myocardial infarction and cardiac death) rate among patients found not to have significant CAD on CCTA exceeds 1%|binomial proportion|0.1|||||TWO_SIDED|95.0|-5.5|5.7|||||Exact confidence intervals for the difference in proportions|Compare Cardiac Death between groups||5.7|-5.5|
70919243|NCT00933400|141329290|EQUIVALENCE|The trial was powered to test the principal hypothesis that the major adverse cardiac event (MACE, including myocardial infarction and cardiac death) rate among patients found not to have significant CAD on CCTA exceeds 1%|binomial proportion|0.1|||||TWO_SIDED|95.0|-5.6|5.9|||||Exact confidence intervals for the difference in proportions|Compare AMI between groups||5.9|-5.6|
70919244|NCT00933400|141329290|EQUIVALENCE|The trial was powered to test the principal hypothesis that the major adverse cardiac event (MACE, including myocardial infarction and cardiac death) rate among patients found not to have significant CAD on CCTA exceeds 1%|binomial proportion|3.0|||||TWO_SIDED|95.0|-5.5|6.0|||||Exact confidence intervals for the difference in proportions|Compare MACE between groups||6.0|-5.5|
70972014|NCT05048719|141450436|OTHER||Odds Ratio (OR)|13.93|||<|0.001|TWO_SIDED|95.0|4.51|43.01|||Regression, Logistic|||||43.01|4.51|<0.001
70919245|NCT00933400|141329290|EQUIVALENCE|The trial was powered to test the principal hypothesis that the major adverse cardiac event (MACE, including myocardial infarction and cardiac death) rate among patients found not to have significant CAD on CCTA exceeds 1%|binomial proportion|1.3|||||TWO_SIDED|95.0|-4.4|7.0|||||Exact confidence intervals for the difference in proportions|Compare Revascularization between groups||7.0|-4.4|
70919246|NCT02299375|141329309|SUPERIORITY_OR_OTHER||Adjusted median|1.04|STANDARD_DEVIATION|0.28|||TWO_SIDED|95.0|0.63|1.73|||||Data presented above are for 95% equal-tailed credible intervals. The estimated posterior probability that the true ratio losmapimod/placebo is \<1 assuming noninformative priors is 0.44.The estimated posterior probability that the true ratio losmapi|||1.73|0.63|
70919247|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.026||||0.371|TWO_SIDED|95.0|-0.031|0.084||Analysis performed using a Mixed-effect Model Repeated Measures (MMRM) with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 2|||0.084|-0.031|0.371
70919248|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.035||||0.244|TWO_SIDED|95.0|-0.024|0.093||Analysis performed using a Mixed-effect Repeated Measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 4|||0.093|-0.024|0.244
70919249|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.059||||0.05|TWO_SIDED|95.0|0.0|0.119||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 8|||0.119|-0.000|0.050
71093981|NCT04950686|141695708|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.08||0.086|TWO_SIDED||||||Mixed Models Analysis|||||||0.086
70972015|NCT05048719|141450437|OTHER||Odds Ratio (OR)|8.19|||<|0.001|TWO_SIDED|95.0|2.93|22.9|||Regression, Logistic|||||22.90|2.93|<0.001
70972016|NCT05048719|141450437|OTHER||Odds Ratio (OR)|25.02|||<|0.001|TWO_SIDED|95.0|7.57|82.69|||Regression, Logistic|||||82.69|7.57|<0.001
70972017|NCT05048719|141450437|OTHER||Odds Ratio (OR)|62.31|||<|0.001|TWO_SIDED|95.0|12.26|316.63|||Regression, Logistic|||||316.63|12.26|<0.001
70972018|NCT05048719|141450437|OTHER||Odds Ratio (OR)|67.57|||<|0.001|TWO_SIDED|95.0|17.56|259.97|||Regression, Logistic|||||259.97|17.56|<0.001
70972019|NCT05048719|141450437|OTHER||Odds Ratio (OR)|129.55|||<|0.001|TWO_SIDED|95.0|26.72|628.09|||Regression, Logistic|||||628.09|26.72|<0.001
70972020|NCT05048719|141450437|OTHER||Odds Ratio (OR)|1.13||||0.802|TWO_SIDED|95.0|0.43|2.96|||Regression, Logistic|||||2.96|0.43|0.802
70972021|NCT05048719|141450437|OTHER||Odds Ratio (OR)|3.46||||0.026|TWO_SIDED|95.0|1.16|10.31|||Regression, Logistic|||||10.31|1.16|0.026
70972022|NCT05048719|141450437|OTHER||Odds Ratio (OR)|8.61||||0.006|TWO_SIDED|95.0|1.83|40.51|||Regression, Logistic|||||40.51|1.83|0.006
70972023|NCT05048719|141450437|OTHER||Odds Ratio (OR)|9.34|||<|0.001|TWO_SIDED|95.0|2.67|32.71|||Regression, Logistic|||||32.71|2.67|<0.001
70972024|NCT05048719|141450437|OTHER||Odds Ratio (OR)|17.9|||<|0.001|TWO_SIDED|95.0|4.02|79.7|||Regression, Logistic|||||79.70|4.02|<0.001
70972025|NCT05048719|141450438|OTHER||LS Mean Difference|-21.5|||<|0.001|TWO_SIDED|95.0|-32.7|-10.3|||Mixed Models Analysis|||||-10.3|-32.7|<0.001
70972026|NCT05048719|141450438|OTHER||LS Mean Difference|-42.5|||<|0.001|TWO_SIDED|95.0|-53.4|-31.7|||Mixed Models Analysis|||||-31.7|-53.4|<0.001
70972027|NCT05048719|141450438|OTHER||LS Mean Difference|-41.0|||<|0.001|TWO_SIDED|95.0|-52.7|-29.3|||Mixed Models Analysis|||||-29.3|-52.7|<0.001
70972028|NCT05048719|141450438|OTHER||LS Mean Difference|-42.7|||<|0.001|TWO_SIDED|95.0|-53.5|-32.0|||Mixed Models Analysis|||||-32.0|-53.5|<0.001
70972029|NCT05048719|141450438|OTHER||LS Mean Difference|-44.7|||<|0.001|TWO_SIDED|95.0|-55.3|-34.2|||Mixed Models Analysis|||||-34.2|-55.3|<0.001
70972030|NCT05048719|141450438|OTHER||LS Mean Difference|0.6|||<|0.001|TWO_SIDED|95.0|-10.6|11.8|||Mixed Models Analysis|||||11.8|-10.6|<0.001
70972031|NCT05048719|141450438|OTHER||LS Mean Difference|-20.5|||<|0.001|TWO_SIDED|95.0|-31.4|-9.5|||Mixed Models Analysis|||||-9.5|-31.4|<0.001
70972032|NCT05048719|141450438|OTHER||LS Mean Difference|-19.0||||0.002|TWO_SIDED|95.0|-30.7|-7.2|||Mixed Models Analysis|||||-7.2|-30.7|0.002
71093982|NCT04950686|141695708|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.08||0.515|TWO_SIDED||||||Mixed Models Analysis|||||||0.515
70972033|NCT05048719|141450438|OTHER||LS Mean Difference|-20.7|||<|0.001|TWO_SIDED|95.0|-31.4|-9.9|||Mixed Models Analysis|||||-9.9|-31.4|<0.001
70972034|NCT05048719|141450438|OTHER||LS Mean Difference|-22.7|||<|0.001|TWO_SIDED|95.0|-33.2|-12.1|||Mixed Models Analysis|||||-12.1|-33.2|<0.001
70972035|NCT05048719|141450439|OTHER||LS Mean Difference|-1.6||||0.153|TWO_SIDED|95.0|-3.7|0.6|||Mixed Models Analysis|||||0.6|-3.7|0.153
70972036|NCT05048719|141450439|OTHER||LS Mean Difference|-4.3|||<|0.001|TWO_SIDED|95.0|-6.4|-2.2|||Mixed Models Analysis|||||-2.2|-6.4|<0.001
70972037|NCT05048719|141450439|OTHER||LS Mean Difference|-7.6|||<|0.001|TWO_SIDED|95.0|-9.8|-5.3|||Mixed Models Analysis|||||-5.3|-9.8|<0.001
70972038|NCT05048719|141450439|OTHER||LS Mean Difference|-7.4|||<|0.001|TWO_SIDED|95.0|-9.4|-5.3|||Mixed Models Analysis|||||-5.3|-9.4|<0.001
70972039|NCT05048719|141450439|OTHER||LS Mean Difference|-7.9|||<|0.001|TWO_SIDED|95.0|-9.9|-5.9|||Mixed Models Analysis|||||-5.9|-9.9|<0.001
70972040|NCT05048719|141450439|OTHER||LS Mean Difference|0.1||||0.914|TWO_SIDED|95.0|-2.0|2.3|||Mixed Models Analysis|||||2.3|-2.0|0.914
70972041|NCT05048719|141450439|OTHER||LS Mean Difference|-2.6||||0.015|TWO_SIDED|95.0|-4.7|-0.5|||Mixed Models Analysis|||||-0.5|-4.7|0.015
70972042|NCT05048719|141450439|OTHER||LS Mean Difference|-5.9|||<|0.001|TWO_SIDED|95.0|-8.1|-3.6|||Mixed Models Analysis|||||-3.6|-8.1|<0.001
70972043|NCT05048719|141450439|OTHER||LS Mean Difference|-5.7|||<|0.001|TWO_SIDED|95.0|-7.8|-3.6|||Mixed Models Analysis|||||-3.6|-7.8|<0.001
70972044|NCT05048719|141450439|OTHER||LS Mean Difference|-6.2|||<|0.001|TWO_SIDED|95.0|-8.3|-4.2|||Mixed Models Analysis|||||-4.2|-8.3|<0.001
70972045|NCT02229552|141450451|OTHER|Repeated measures analysis of variance with zbmi for each year as the repeated dependent measure.|Mean Difference (Final Values)|3.0||||0.051|TWO_SIDED||||||ANOVA|||||||0.051
70972046|NCT04872101|141450452|SUPERIORITY||Risk Difference (RD)|22.2|||<|0.001|TWO_SIDED|95.0|15.8|28.5||5% significance level (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||28.5|15.8|<0.001
70972047|NCT04872101|141450453|SUPERIORITY||Risk Difference (RD)|22.9|||<|0.001|TWO_SIDED|95.0|16.0|29.8||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||29.8|16.0|<0.001
70972048|NCT04872101|141450454|SUPERIORITY||Risk Difference (RD)|6.5||||0.043|TWO_SIDED|95.0|0.8|12.3||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||12.3|0.8|0.043
70972049|NCT04872101|141450455|SUPERIORITY||Risk Difference (RD)|27.4|||<|0.001|TWO_SIDED|95.0|19.0|35.8||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||35.8|19.0|<0.001
71154036|NCT03653507|141800304|SUPERIORITY||Hazard Ratio (HR)|1.012||||0.4654|TWO_SIDED|95.0|0.772|1.328|||Log Rank||Log-rank test stratified by:\* Region (Asia vs Non-Asia), \* Number of organs with metastatic sites (0 to 2 vs \>= 3), \* Prior gastrectomy (Yes or No)|||1.328|0.772|0.4654
70972050|NCT04872101|141450456|SUPERIORITY||Risk Difference (RD)|23.7|||<|0.001|TWO_SIDED|95.0|15.1|32.2||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||32.2|15.1|<0.001
70972051|NCT04872101|141450457|SUPERIORITY||Risk Difference (RD)|29.0|||<|0.001|TWO_SIDED|95.0|21.3|36.7||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||36.7|21.3|<0.001
70972052|NCT04872101|141450458|SUPERIORITY||Risk Difference (RD)|18.3|||<|0.001|TWO_SIDED|95.0|11.0|25.6||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||25.6|11.0|<0.001
70972053|NCT04872101|141450459|SUPERIORITY||Risk Difference (RD)|6.6||||0.031|TWO_SIDED|95.0|1.1|12.0||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||12.0|1.1|0.031
70972054|NCT04872101|141450460|SUPERIORITY||Risk Difference (RD)|25.0|||<|0.001|TWO_SIDED|95.0|17.5|32.5||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||32.5|17.5|<0.001
70972055|NCT04872101|141450461|SUPERIORITY||Risk Difference (RD)|16.9|||<|0.001|TWO_SIDED|95.0|10.2|23.7||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||23.7|10.2|<0.001
70972056|NCT04872101|141450462|SUPERIORITY||Risk Difference (RD)|26.0|||<|0.001|TWO_SIDED|95.0|17.0|35.1||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||35.1|17.0|<0.001
70972057|NCT04872101|141450463|SUPERIORITY||Risk Difference (RD)|29.6|||<|0.001|TWO_SIDED|95.0|21.7|37.4||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||37.4|21.7|<0.001
70972058|NCT04872101|141450464|SUPERIORITY||Risk Difference (RD)|20.5|||<|0.001|TWO_SIDED|95.0|13.1|27.8||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||27.8|13.1|<0.001
70972059|NCT04872101|141450465|SUPERIORITY||Risk Difference (RD)|22.2|||<|0.001|TWO_SIDED|95.0|15.4|29.0||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||29.0|15.4|<0.001
71093983|NCT04950686|141695709|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.597|TWO_SIDED||||||Mixed Models Analysis|||||||0.597
71154037|NCT03653507|141800305|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.4478|TWO_SIDED|95.0|0.673|1.577|||Log Rank||Log-rank test stratified by:\* Region (Asia vs Non-Asia), \* Number of organs with metastatic sites (0 to 2 vs \>= 3), \* Prior gastrectomy (Yes or No)|||1.577|0.673|0.4478
70919250|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.002||||0.942|TWO_SIDED|95.0|-0.063|0.058||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 12|||0.058|-0.063|0.942
70919251|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.127|TWO_SIDED|95.0|-0.014|0.114||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 18|||0.114|-0.014|0.127
70919252|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.079||||0.024|TWO_SIDED|95.0|0.011|0.148||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 26|||0.148|0.011|0.024
70919253|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.086||||0.057|TWO_SIDED|95.0|-0.003|0.174||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 39|||0.174|-0.003|0.057
70919254|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.481|TWO_SIDED|95.0|-0.09|0.191||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 52|||0.191|-0.090|0.481
70919255|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.014||||0.521|TWO_SIDED|95.0|-0.03|0.059||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 2|||0.059|-0.030|0.521
70919256|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.084|TWO_SIDED|95.0|-0.005|0.086||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 4|||0.086|-0.005|0.084
70919257|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.033||||0.266|TWO_SIDED|95.0|-0.025|0.09||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 8|||0.090|-0.025|0.266
70919258|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.012||||0.665|TWO_SIDED|95.0|-0.066|0.042||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 12|||0.042|-0.066|0.665
70919259|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.023||||0.489|TWO_SIDED|95.0|-0.043|0.09||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 18|||0.090|-0.043|0.489
70919260|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.099||||0.007|TWO_SIDED|95.0|0.028|0.17||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 26|||0.170|0.028|0.007
70919261|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.055||||0.248|TWO_SIDED|95.0|-0.039|0.148||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 39|||0.148|-0.039|0.248
70972060|NCT04872101|141450466|SUPERIORITY||Risk Difference (RD)|31.3|||<|0.001|TWO_SIDED|95.0|23.1|39.5||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||39.5|23.1|<0.001
70972061|NCT04872101|141450467|SUPERIORITY||Risk Difference (RD)|31.0|||<|0.001|TWO_SIDED|95.0|22.7|39.3||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||39.3|22.7|<0.001
71093984|NCT04950686|141695709|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.09||0.551|TWO_SIDED||||||Mixed Models Analysis|||||||0.551
70919262|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.043||||0.506|TWO_SIDED|95.0|-0.087|0.172||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 52|||0.172|-0.087|0.506
70919263|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.051||||0.223|TWO_SIDED|95.0|-0.032|0.134||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 2|||0.134|-0.032|0.223
71093985|NCT04950686|141695710|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.634|TWO_SIDED||||||Mixed Models Analysis|||||||0.634
70972062|NCT04872101|141450468|SUPERIORITY||Mean Difference (Net)|-45.5|||<|0.001|TWO_SIDED|95.0|-56.4|-34.6||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HECSI score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-34.6|-56.4|<0.001
70972063|NCT04872101|141450469|SUPERIORITY||Mean Difference (Net)|-3.9|||<|0.001|TWO_SIDED|95.0|-5.0|-2.8||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline DLQI score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-2.8|-5.0|<0.001
70972064|NCT04872101|141450470|SUPERIORITY||Mean Difference (Net)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.4|-1.4||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HESD score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-1.4|-2.4|<0.001
70972065|NCT04872101|141450471|SUPERIORITY||Median Difference (Net)|-2.0|||<|0.001|TWO_SIDED|95.0|-2.5|-1.4||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HESD itch score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-1.4|-2.5|<0.001
70972066|NCT04872101|141450472|SUPERIORITY||Mean Difference (Net)|-2.0|||<|0.001|TWO_SIDED|95.0|-2.6|-1.5||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HESD pain score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-1.5|-2.6|<0.001
70972067|NCT04872101|141450473|SUPERIORITY||Median Difference (Net)|-0.81|||<|0.001|TWO_SIDED|95.0|-0.99|-0.62||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HEIS score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-0.62|-0.99|<0.001
70972068|NCT04872101|141450474|SUPERIORITY||Mean Difference (Net)|-0.82|||<|0.001|TWO_SIDED|95.0|-1.01|-0.62||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HEIS PDAL score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-0.62|-1.01|<0.001
70972069|NCT04872101|141450475|SUPERIORITY||Risk Difference (RD)|26.4|||<|0.001|TWO_SIDED|95.0|17.0|35.9||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||35.9|17.0|<0.001
70972070|NCT03354663|141450481|OTHER|Single arm trial|Proportion|0.047|||<|0.0001|ONE_SIDED|95.0||0.0864|||Binomial Exact Test|||"The hypothesis is formally expressed as:~H0: P ≥ 16.2% Ha: P \< 16.2%, where P is the percentage of subjects with a primary safety endpoint event. The hypothesis will be tested based on a one-sided exact test of binomial proportions at the one-sided 0.05 alpha level."||0.0864||<0.0001
70972071|NCT03354663|141450482|OTHER|"The hypothesis is formally expressed as:~H0: P \< 90% Ha: P ≥ 90%, where P is the percentage of subjects with acute success. The hypothesis will be tested based on a one-sided exact test of binomial proportions at the one-sided 0.05 alpha level. Rejection of the null hypothesis will indicate study success."|Proportion|0.98||||0.0001|ONE_SIDED|95.0|0.9495||||Binomial Exact Test||||||0.9495|0.0001
70972072|NCT03354663|141450487|OTHER||Kaplan-Meier Survival Estimate|82.2|||||TWO_SIDED|95.0|74.7|87.6|||||Kaplan-Meier estimate of freedom from recurrence at 1-year|Kaplan Meier Estimate of freedom from recurrence.||87.6|74.7|
70972073|NCT03354663|141450488|OTHER||Kaplan-Meier survival estimate|68.2|||||TWO_SIDED|95.0|59.9|75.1||||||Kaplan-Meier estimate of freedom from recurrence or need for anti-arrhythmic medication||75.1|59.9|
71154038|NCT03653507|141800306|SUPERIORITY||Hazard Ratio (HR)|0.869||||0.167|TWO_SIDED|95.0|0.655|1.153|||Log Rank||Log-rank test stratified by:\* Region (Asia vs Non-Asia), \* Number of organs with metastatic sites (0 to 2 vs \>= 3), \* Prior gastrectomy (Yes or No)|||1.153|0.655|0.1670
70919264|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.046||||0.276|TWO_SIDED|95.0|-0.037|0.129||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 4|||0.129|-0.037|0.276
70919265|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.075||||0.131|TWO_SIDED|95.0|-0.023|0.173||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 8|||0.173|-0.023|0.131
70919266|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.003||||0.949|TWO_SIDED|95.0|-0.084|0.09||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 12|||0.090|-0.084|0.949
70919267|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.059||||0.259|TWO_SIDED|95.0|-0.044|0.163||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 18|||0.163|-0.044|0.259
70919268|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.073||||0.152|TWO_SIDED|95.0|-0.027|0.172||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 26|||0.172|-0.027|0.152
70919269|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.114||||0.076|TWO_SIDED|95.0|-0.012|0.241||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 39|||0.241|-0.012|0.076
70919270|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.171||||0.107|TWO_SIDED|95.0|-0.038|0.381||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 52|||0.381|-0.038|0.107
70919271|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.025||||0.484|TWO_SIDED|95.0|-0.046|0.097||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 2|||0.097|-0.046|0.484
70919272|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.037||||0.256|TWO_SIDED|95.0|-0.027|0.1||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 4|||0.100|-0.027|0.256
70919273|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.052||||0.184|TWO_SIDED|95.0|-0.025|0.128||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 8|||0.128|-0.025|0.184
70919274|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.001||||0.97|TWO_SIDED|95.0|-0.077|0.074||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 12|||0.074|-0.077|0.970
70919275|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.025||||0.608|TWO_SIDED|95.0|-0.07|0.12||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 18|||0.120|-0.070|0.608
70919276|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.084||||0.071|TWO_SIDED|95.0|-0.007|0.175||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 26|||0.175|-0.007|0.071
70919277|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.028||||0.622|TWO_SIDED|95.0|-0.085|0.141||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 39|||0.141|-0.085|0.622
70919278|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.102||||0.277|TWO_SIDED|95.0|-0.086|0.291||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 52|||0.291|-0.086|0.277
70972074|NCT03691974|141450502|SUPERIORITY||Least Square (LS) Mean Difference|0.4||||0.4192|TWO_SIDED|95.0|-0.55|1.32||Analyses are based on Mixed Model for Repeated Measures (MMRM) model with terms for baseline nerve conduction test score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|Mixed Model for Repeated Measures (MMRM)|||||1.32|-0.55|0.4192
71154039|NCT03653507|141800307|SUPERIORITY|||||||0.2219||||||Based on 1-sided Cochran-Mantel-Haenszel (CMH) test. Stratification factors were Region, Number of Metastatic Sites and Prior Gastrectomy.|Cochran-Mantel-Haenszel|||||||0.2219
70919279|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.056||||0.241|TWO_SIDED|95.0|-0.038|0.15||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 2|||0.150|-0.038|0.241
70919280|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.045||||0.348|TWO_SIDED|95.0|-0.049|0.14|||MMRM||FVC Pre-dose, Week 4|||0.140|-0.049|0.348
70919281|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.073||||0.138|TWO_SIDED|95.0|-0.024|0.169||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 8|||0.169|-0.024|0.138
71093986|NCT04950686|141695710|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.308|TWO_SIDED||||||Mixed Models Analysis|||||||0.308
71093987|NCT04950686|141695711|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.06||0.415|TWO_SIDED||||||Mixed Models Analysis|||||||0.415
70972075|NCT03691974|141450503|SUPERIORITY||LS Mean Difference|0.4||||0.0521|TWO_SIDED|95.0|0.0|0.8||Analyses are based on MMRM model with terms for baseline nerve conduction test score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||0.80|-0.00|0.0521
70972076|NCT03691974|141450504|SUPERIORITY||LS Mean Difference|1.3||||0.1593|TWO_SIDED|95.0|-0.52|3.15||Analyses are based on MMRM model with terms for baseline nerve conduction test score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||3.15|-0.52|0.1593
70972077|NCT03691974|141450505|SUPERIORITY||LS Mean Difference|-0.2||||0.7757|TWO_SIDED|95.0|-1.59|1.19||Analyses are based on MMRM model with terms for baseline nerve conduction test score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||1.19|-1.59|0.7757
70972078|NCT03691974|141450506|SUPERIORITY||LS Mean Difference|-0.4||||0.6063|TWO_SIDED|95.0|-1.87|1.09||Analyses are based on MMRM model with terms for baseline nerve conduction test score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||1.09|-1.87|0.6063
70972079|NCT03691974|141450507|SUPERIORITY||LS Mean Difference|-1.0||||0.4203|TWO_SIDED|95.0|-3.3|1.39||Analyses are based on MMRM model with terms for baseline nerve conduction test score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||1.39|-3.30|0.4203
70972080|NCT03691974|141450508|SUPERIORITY||LS Mean Difference|-1.33||||0.001|TWO_SIDED|95.0|-2.123|-0.538||Analyses are based on multiple imputation with MMRM model with terms for baseline WOMAC subscale score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||-0.538|-2.123|0.0010
70972081|NCT03691974|141450509|SUPERIORITY||LS Mean Difference|-1.42||||0.0005|TWO_SIDED|95.0|-2.212|-0.625||Analyses were based on multiple imputation with MMRM model with terms for baseline WOMAC subscale score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||-0.625|-2.212|0.0005
70972082|NCT01661140|141450528|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority if the difference between treatments is statistically significant and the lower limit of the 95% confidence interval (CI) is greater than 0.9.|Odds Ratio (OR)|1.803||||0.036|TWO_SIDED|95.0|1.037|3.133|||Analysis by logistic regression|||Comparison was Tapering MTX : MTX maintenance. Last post-baseline EULAR response recorded used for participants with a missing result at Week 60.||3.133|1.037|0.036
71093988|NCT04950686|141695711|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.06||0.721|TWO_SIDED||||||Mixed Models Analysis|||||||0.721
70972083|NCT00746252|141450546|OTHER|||||||0.495||||||Threshold of significance is p\<.05|t-test, 2 sided|||Comparison of mean weight gain between groups.||||.495
70972084|NCT01870401|141450559|NON_INFERIORITY|The protocol identified a non-inferiority bound equal to 0.12 (12%).|||||<|0.025|||||||Farrington and Manning|||The primary safety hypothesis is as follows: H0: pControl - pDCB ≥ and H1: pControl (alpha) pDCB \< where p is the success rate in each arm and (alpha) is the non-inferiority bound.||||<0.025
70972085|NCT01870401|141450560|SUPERIORITY|||||||0.0222|||||||Wald Test|One-sided Wald test based on model estimate of DCB treatment effect and subject as a random effect.||||||0.0222
70972086|NCT01602692|141450586|OTHER|||||||0.24|||||||ANOVA|||End of PACU Mean Pain Level p-value between arms||||0.24
70972087|NCT01602692|141450586|OTHER|||||||0.76|||||||ANOVA|||First 24 hrs Post-op Mean Current Pain p-value between arms||||0.76
70972088|NCT01602692|141450586|OTHER|||||||0.78|||||||ANOVA|||First 24 hrs Post-op Mean Worst Pain p-value between arms||||0.78
70972089|NCT01602692|141450586|OTHER|||||||0.41|||||||ANOVA|||First 24 hrs Post-op Mean Least Pain p-value between arms||||0.41
70972090|NCT01602692|141450587|OTHER|||||||0.1|||||||ANOVA|||PACU IV hydromorphone p-value between arms||||0.10
70972091|NCT01602692|141450587|OTHER|||||||0.71|||||||ANOVA|||First 24 hr Post-op oxycodone p-value between arms||||0.71
70972092|NCT00493870|141450610|OTHER|||||||0.05|||||||Log Rank|||||||0.05
71093989|NCT04950686|141695712|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.06||0.261|TWO_SIDED||||||Mixed Models Analysis|||||||0.261
71093990|NCT04950686|141695712|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.369|TWO_SIDED||||||Mixed Models Analysis|||||||0.369
71154040|NCT03653507|141800308|SUPERIORITY||Hazard Ratio (HR)|0.781||||0.0826|TWO_SIDED|95.0|0.552|1.105|||Log Rank||Log-rank test stratified by:\* Region (Asia vs Non-Asia), \* Number of organs with metastatic sites (0 to 2 vs \>= 3), \* Prior gastrectomy (Yes or No)|||1.105|0.552|0.0826
70972093|NCT03605680|141450620|SUPERIORITY||Least Squares (LS ) Mean Difference|-3.15|||=|0.0193|TWO_SIDED|95.0|-5.79|-0.51|||MMRM||||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|-0.51|-5.79|=0.0193
70972094|NCT03605680|141450620|SUPERIORITY||LS Mean Difference|-2.74|||=|0.0392|TWO_SIDED|95.0|-5.35|-0.14|||MMRM|||||-0.14|-5.35|=0.0392
70972095|NCT03605680|141450621|SUPERIORITY||LS Mean Difference|-0.27|||=|0.0232|TWO_SIDED|95.0|-0.5|-0.04|||MMRM||||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|-0.04|-0.50|=0.0232
71093991|NCT04950686|141695713|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.06||0.124|TWO_SIDED||||||Mixed Models Analysis|||||||0.124
71154041|NCT04401267|141800340|SUPERIORITY|||||||0.7139|||||||Fisher Exact|||||||0.7139
70972096|NCT03605680|141450621|SUPERIORITY||LS Mean Difference|-0.28|||=|0.0162|TWO_SIDED|95.0|-0.51|-0.05|||MMRM||||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|-0.05|-0.51|=0.0162
70972097|NCT00883337|141450641|SUPERIORITY_OR_OTHER|||||||0.5953||95.0||||"Hochberg testing procedure:~* a-priori threshold for statistical significance ≤0.05 for the largest p-value of the 2 pair-wise comparisons~* a-priori threshold for statistical significance ≤0.025 for the other p-value if the largest p-value \>0.05"|Log Rank|Two-sided Log Rank test with the region of enrollment and baseline EDSS stratum as stratification factors||"The study was sized to detect a difference between Teriflunomide and Rebif groups in the time to failure at a significance level of 0.025 with a power of 81%.~Null hypothesis:~* H1: No difference between Teriflunomide 14 mg and Rebif~* H2: No difference between Teriflunomide 7 mg and Rebif"||||0.5953
70972098|NCT00883337|141450641|SUPERIORITY_OR_OTHER|||||||0.519||95.0||||"Hochberg testing procedure:~* a-priori threshold for statistical significance ≤0.05 for the largest p-value of the 2 pair-wise comparisons~* a-priori threshold for statistical significance ≤0.025 for the other p-value if the largest p-value \>0.05"|Log Rank|Two-sided Log Rank test with the region of enrollment and baseline EDSS stratum as stratification factors||"Null hypothesis:~* H1: No difference between Teriflunomide 14 mg and Rebif~* H2: No difference between Teriflunomide 7 mg and Rebif"||||0.5190
70972099|NCT00527605|141450648|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-14.23|||<|0.0001||95.0|-20.23|-8.22|||t-test, 2 sided||Dutasteride arm minus placebo arm.|||-8.22|-20.23|<0.0001
70972100|NCT01008280|141450690|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||Wald Chi-squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed time effects for the number of drinking days.||||<0.01
70972101|NCT01008280|141450690|SUPERIORITY_OR_OTHER||||||>|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group effects for the number of drinking days.||||>0.01
70972102|NCT01008280|141450690|SUPERIORITY_OR_OTHER||||||>|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed time by group effects for the number of drinking days.||||>0.01
70972103|NCT01008280|141450691|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed time effects for the number of drinks.||||<0.01
70972104|NCT01008280|141450691|SUPERIORITY_OR_OTHER||||||>|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group effects for the number of drinks.||||>0.01
70972105|NCT01008280|141450691|SUPERIORITY_OR_OTHER||||||>|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group by time effects for the number of drinks.||||>0.01
70972106|NCT01008280|141450692|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed time effects for the number of heavy drinking days.||||<0.01
70972107|NCT01008280|141450692|SUPERIORITY_OR_OTHER||||||>|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group effects for the number of heavy drinking days.||||>0.01
70972108|NCT01008280|141450692|SUPERIORITY_OR_OTHER||||||>|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group by time effects for the number of heavy drinking days.||||>0.01
71093992|NCT04950686|141695713|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.06||0.794|TWO_SIDED||||||Mixed Models Analysis|||||||0.794
71093993|NCT04950686|141695714|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.011|TWO_SIDED||||||Mixed Models Analysis|||||||0.011
71154042|NCT05230433|141800439|OTHER||Percent Consumed|86.0||||0.15|TWO_SIDED|||||p-value was not adjusted for multiple comparisons|Chi-squared|||High fat agents were weighed pre- and post- providing the shake to the participant. All containers were tared to take into account straw, lid, and glass weight. Percentage of high-fat challenge consumed was calculated by post-shake weight / pre-shake weight. 13 out of 15 partcipants drank \>75% of the shake.||||0.15
70919282|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.012||||0.813|TWO_SIDED|95.0|-0.111|0.087||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 12|||0.087|-0.111|0.813
70919283|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.073||||0.172|TWO_SIDED|95.0|-0.032|0.177||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 18|||0.177|-0.032|0.172
70919284|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.067||||0.242|TWO_SIDED|95.0|-0.045|0.18||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 26|||0.180|-0.045|0.242
70919285|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.082||||0.267|TWO_SIDED|95.0|-0.063|0.228||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 39|||0.228|-0.063|0.267
70919286|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.083||||0.471|TWO_SIDED|95.0|-0.143|0.309||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 52|||0.309|-0.143|0.471
70919287|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.045||||0.315|TWO_SIDED|95.0|-0.043|0.132||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 2|||0.132|-0.043|0.315
70919288|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.054||||0.143|TWO_SIDED|95.0|-0.018|0.126||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 4|||0.126|-0.018|0.143
70919289|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.072||||0.111|TWO_SIDED|95.0|-0.017|0.16||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 8|||0.160|-0.017|0.111
71008724|NCT02055976|141525247|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-31.88|STANDARD_ERROR_OF_MEAN|7.071|<|0.001|TWO_SIDED|95.0|-45.925|-17.836|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-17.836|-45.925|<0.001
70919290|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.012||||0.783|TWO_SIDED|95.0|-0.075|0.1||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 12|||0.100|-0.075|0.783
70919291|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.059||||0.283|TWO_SIDED|95.0|-0.049|0.167||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 18|||0.167|-0.049|0.283
70919292|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.138||||0.038|TWO_SIDED|95.0|0.008|0.267||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 26|||0.267|0.008|0.038
70919293|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.048||||0.467|TWO_SIDED|95.0|-0.083|0.18||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 39|||0.180|-0.083|0.467
70919294|NCT02299375|141329312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.042||||0.64|TWO_SIDED|95.0|-0.138|0.222||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 52|||0.222|-0.138|0.640
70919295|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.661|TWO_SIDED|95.0|-2.08|3.27||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 2|||3.27|-2.08|0.661
70919296|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.44||||0.074|TWO_SIDED|95.0|-0.24|5.12||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 6|||5.12|-0.24|0.074
70919297|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.52||||0.21|TWO_SIDED|95.0|-1.43|6.46||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 8|||6.46|-1.43|0.210
70919298|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.933|TWO_SIDED|95.0|-3.4|3.12||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 12|||3.12|-3.40|0.933
71093994|NCT04950686|141695714|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.068|TWO_SIDED||||||Mixed Models Analysis|||||||0.068
71093995|NCT04950686|141695715|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.585|TWO_SIDED||||||Mixed Models Analysis|||||||0.585
71093996|NCT04950686|141695715|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.08||0.338|TWO_SIDED||||||Mixed Models Analysis|||||||0.338
71093997|NCT04950686|141695716|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.259|TWO_SIDED||||||Mixed Models Analysis|||||||0.259
71093998|NCT04950686|141695716|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.003|STANDARD_ERROR_OF_MEAN|0.05||0.95|TWO_SIDED||||||Mixed Models Analysis|||||||0.950
71093999|NCT04950686|141695717|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.05||0.411|TWO_SIDED||||||Mixed Models Analysis|||||||0.411
71094000|NCT04950686|141695717|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.05||0.491|TWO_SIDED||||||Mixed Models Analysis|||||||0.491
71094001|NCT04950686|141695718|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.498|TWO_SIDED||||||Mixed Models Analysis|||||||0.498
71094002|NCT04950686|141695718|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.573|TWO_SIDED||||||Mixed Models Analysis|||||||0.573
71094003|NCT04950686|141695719|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.06||0.128|TWO_SIDED||||||Mixed Models Analysis|||||||0.128
71094004|NCT04950686|141695719|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.08||0.013|TWO_SIDED||||||Mixed Models Analysis|||||||0.013
71094005|NCT04950686|141695720|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.0001|STANDARD_ERROR_OF_MEAN|0.07||0.999|TWO_SIDED||||||Mixed Models Analysis|||||||0.999
71094006|NCT04950686|141695720|EQUIVALENCE|This arm will receive Health Aware for Young Adults in between the pretest and posttest questionnaire. Health Aware for Young Adults is a web-based sexual and relationship health promotion program. The program contains the same health content as Media Aware for Young Adults but without the media literacy education components. The program is self-paced and includes four modules.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.08||0.638|TWO_SIDED||||||Mixed Models Analysis|||||||0.638
71094007|NCT04950686|141695721|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.07||0.841|TWO_SIDED||||||Mixed Models Analysis|||||||0.841
71094008|NCT04950686|141695721|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.08||0.27|TWO_SIDED||||||Mixed Models Analysis|||||||0.270
71094009|NCT04950686|141695722|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.08||0.94|TWO_SIDED||||||Mixed Models Analysis|||||||0.940
71094010|NCT04950686|141695722|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.001|STANDARD_ERROR_OF_MEAN|0.09||0.992|TWO_SIDED||||||Mixed Models Analysis|||||||0.992
71094011|NCT04950686|141695723|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.06||0.47|TWO_SIDED||||||Mixed Models Analysis|||||||0.470
71094012|NCT04950686|141695723|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.06||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.130
71094013|NCT04950686|141695724|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.931|TWO_SIDED||||||Mixed Models Analysis|||||||0.931
71094014|NCT04950686|141695724|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.666|TWO_SIDED||||||Mixed Models Analysis|||||||0.666
71094015|NCT04950686|141695725|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.822|TWO_SIDED||||||Mixed Models Analysis|||||||0.822
70919299|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.7||||0.091|TWO_SIDED|95.0|-0.43|5.82||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 18|||5.82|-0.43|0.091
70919300|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.69||||0.018|TWO_SIDED|95.0|0.82|8.56||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 26|||8.56|0.82|0.018
70919301|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.3||||0.103|TWO_SIDED|95.0|-0.69|7.29||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 39|||7.29|-0.69|0.103
70919302|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.16||||0.448|TWO_SIDED|95.0|-3.5|7.82||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 52|||7.82|-3.50|0.448
70919303|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.75||||0.089|TWO_SIDED|95.0|-0.27|3.77||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 2|||3.77|-0.27|0.089
70919304|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.76||||0.095|TWO_SIDED|95.0|-0.31|3.84||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 4|||3.84|-0.31|0.095
71094016|NCT04950686|141695725|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.721|TWO_SIDED||||||Mixed Models Analysis|||||||0.721
71094017|NCT04950686|141695726|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.54|TWO_SIDED||||||Mixed Models Analysis|||||||0.540
70919305|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.19||||0.073|TWO_SIDED|95.0|-0.2|4.58||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 8|||4.58|-0.20|0.073
70919306|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22||||0.853|TWO_SIDED|95.0|-2.08|2.51||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 12|||2.51|-2.08|0.853
70919307|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.37||||0.334|TWO_SIDED|95.0|-1.43|4.17||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 18|||4.17|-1.43|0.334
70919308|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.33||||0.017|TWO_SIDED|95.0|0.61|6.05||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 26|||6.05|0.61|0.017
70919309|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.13||||0.077|TWO_SIDED|95.0|-0.34|6.59||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 39|||6.59|-0.34|0.077
70972109|NCT01485627|141450699|SUPERIORITY||Adjusted mean difference in difference|0.34||||0.05|TWO_SIDED|95.0|0.06|0.62|||Mixed Models Analysis||Models included fixed-effects terms for phase (pre- vs postrandomization), study arm, and the Phase\*Arm interaction. Estimated effect is the between-arm difference in adjusted mean difference from prerandomization to postrandomization samples.|The primary outcome was a composite of 4 prespecified communication measures matched to the goals of communication training, as follows: Active Patient Participation Coding \[APPC\], Verona VR-CoDES, Prognostic and Treatment Choices \[PTCC\] Informing subscale, and PTCC Balanced Framing subscale. The 4 measures were z-score transformed and averaged to produce the composite measure.||0.62|0.06|0.05
70972110|NCT01485627|141450700|SUPERIORITY|||||||0.214|||||||Mixed Models Analysis|||||||0.214
70972111|NCT01485627|141450701|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.05|TWO_SIDED|95.0|-0.56|0.37|||Mixed Models Analysis|||||0.37|-0.56|0.05
70972112|NCT01485627|141450703|SUPERIORITY|||||||0.677|||||||Mixed Models Analysis|||||||0.677
70972113|NCT01485627|141450704|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|||||||0.19
70972114|NCT01142726|141450716|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01|STANDARD_ERROR_OF_MEAN|0.55||0.01|TWO_SIDED|95.0|1.18|3.43|||Regression, Logistic|Statistical testing of the 2 coprimary efficacy endpoints was conducted in a hierarchical fashion to maintain the overall Type I error rate at 5%.|At Month 12|Power estimate assumed 2-sided alpha level of 5% and that 60% of abatacept (ABA)+methotrexate (MX) patients (pts) would be in DAS28-CRP remission at Month 12 compared with 38% of MX monotherapy pts. Also assumed that 48% of ABA monotherapy pts would be in DAS28-CRP remission at Month 12, yielding an expected treatment difference from MX of 10% in favor of ABA monotherapy; 116 pts randomized to ABA monotherapy would yield a half-length of the 95% CI around that 10% treatment difference of 13.5%.||3.43|1.18|0.010
70972115|NCT01142726|141450716|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.51|STANDARD_ERROR_OF_MEAN|1.15||0.045|TWO_SIDED|95.0|1.02|6.18|||Regression, Logistic|Statistical testing of the 2 coprimary efficacy endpoints was conducted in a hierarchical fashion to maintain the overall Type I error rate at 5%.|At Months 12 and 18|Conditional on statistical significance of the 1st coprimary efficacy analysis (CEA), a sample of 116 patients per arm would provide 98% power for the 2nd CEA comparison of the percentage of patients in DAS28-CRP remission at Months 12 and 18 between the abatacept (ABA)+methotrexate (MTX) arm and the MTX monotherapy arm for intent-to treat population. This sample size calculation assumed 30% remission in the ABA+MTX arm and 8% in the monotherapy arm at Month 18 and a 2-sided alpha level of 5%.||6.18|1.02|0.045
70972116|NCT01142726|141450717|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|95.0|0.55|1.57|||||At Month 12|||1.57|0.55|
70972117|NCT01142726|141450717|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|0.81|5.14|||||At Months 12 and 18|||5.14|0.81|
70972118|NCT02111993|141450737|SUPERIORITY_OR_OTHER|||||||0.02||||||This p-value correlates to Δ4 hr cTnT|t-test, 2 sided|||||||0.02
70972119|NCT02111993|141450737|SUPERIORITY_OR_OTHER|||||||0.03||||||This p-value correlates to Δ8 hr cTnT.|t-test, 2 sided|||||||0.03
70972120|NCT02111993|141450737|SUPERIORITY_OR_OTHER|||||||0.16||||||This p-value correlates to Δ20 hr cTnT|t-test, 2 sided|||||||0.16
70972121|NCT02111993|141450738|SUPERIORITY_OR_OTHER|||||||0.04||||||This p-value correlates to Δ4 hr cTnT|t-test, 2 sided|||||||0.04
70972122|NCT02111993|141450738|SUPERIORITY_OR_OTHER|||||||0.06||||||This p-value correlates to Δ8 hr cTnT|t-test, 2 sided|||||||0.06
70972123|NCT02111993|141450738|SUPERIORITY_OR_OTHER|||||||0.16||||||This p-value correlates to Δ20 hr cTnT|t-test, 2 sided|||||||0.16
70972124|NCT02111993|141450739|SUPERIORITY_OR_OTHER|||||||0.17||||||This p-value correlates to Δ4 hr cTnT|t-test, 2 sided|||||||0.17
70972125|NCT02111993|141450739|SUPERIORITY_OR_OTHER|||||||0.19||||||This p-value correlates to Δ8 hr cTnT|t-test, 2 sided|||||||0.19
70972126|NCT02111993|141450739|SUPERIORITY_OR_OTHER|||||||0.38||||||This p-value correlates to Δ20 hr cTnT|t-test, 2 sided|||||||0.38
70972127|NCT00419380|141450745|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Chi-squared|||Two by two contingency table was used to compare our outcome, tube patency yes/no, by our two independent variables, dornase alfa (Pulmozyme®) and Ofloxin.||||.36
70972128|NCT00419380|141450746|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED|||||Two by two contingency table was used to compare our outcome, presence/absence of ear drainage, by our two independent variables, dornase alfa (Pulmozyme®) and Ofloxin.|Chi-squared|||||||.26
70972129|NCT04074928|141450751|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 1.5 for the Day 29/57 GMT ratio (adjusted analysis).|GMT ratio|0.73|||||TWO_SIDED|95.0|0.645|0.836||||||"Non-inferiority, A/H1N1, GMT ratio, Day 29/57~Non-inferiority of the Day 29/57 immune response to the A/H1N1 vaccine strain calculated by GMT ratio (Comparator QIV GMT divided by QIVc GMT)"||0.836|0.645|
70972130|NCT04074928|141450751|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 1.5 for the Day 29/57 GMT ratio (adjusted analysis).|GMT ratio|0.73|||||TWO_SIDED|95.0|0.656|0.809||||||"Non-inferiority, B/Yamagata, GMT ratio, Day 29/57~Non-inferiority of the Day 29/57 immune response to the B/Yamagata vaccine strain calculated by GMT ratio (Comparator QIV GMT divided by QIVc GMT)"||0.809|0.656|
70972131|NCT04074928|141450751|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 1.5 for the Day 29/57 GMT ratio (adjusted analysis).|GMT ratio|0.88|||||TWO_SIDED|95.0|0.791|0.972||||||"Non-inferiority, B/Victoria, GMT ratio, Day 29/57~Non-inferiority of the Day 29/57 immune response to the B/Victoria vaccine strain calculated by GMT ratio (Comparator QIV GMT divided by QIVc GMT)"||0.972|0.791|
70972132|NCT04074928|141450752|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 10% for the Day 29/57 SCR difference.|SCR difference|-11.46|||||TWO_SIDED|95.0|-16.447|-6.423||||||"Non-inferiority, A/H1N1, SCR difference, Day 29/57~Non-inferiority of the immune response to the A/H1N1 vaccine strain by SCR difference (Comparator QIV SCR minus QIVc SCR)"||-6.423|-16.447|
71094018|NCT04950686|141695726|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.003|STANDARD_ERROR_OF_MEAN|0.06||0.956|TWO_SIDED||||||Mixed Models Analysis|||||||0.956
71094019|NCT04950686|141695727|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.06||0.175|TWO_SIDED||||||Mixed Models Analysis|||||||0.175
70919310|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.34||||0.355|TWO_SIDED|95.0|-2.7|7.38||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 52|||7.38|-2.70|0.355
70919311|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.82||||0.044|TWO_SIDED|95.0|0.08|5.55||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 2|||5.55|0.08|0.044
70919312|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.87||||0.032|TWO_SIDED|95.0|0.25|5.49||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 4|||5.49|0.25|0.032
70919313|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.75||||0.025|TWO_SIDED|95.0|0.49|7.01||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 8|||7.01|0.49|0.025
70919314|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.785|TWO_SIDED|95.0|-2.5|3.29||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 12|||3.29|-2.50|0.785
70919315|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.34||||0.052|TWO_SIDED|95.0|-0.03|6.7||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 18|||6.70|-0.03|0.052
70919316|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.53||||0.041|TWO_SIDED|95.0|0.14|6.92||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 26|||6.92|0.14|0.041
70919317|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.19||||0.043|TWO_SIDED|95.0|0.13|8.25||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 39|||8.25|0.13|0.043
70919318|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.67||||0.562|TWO_SIDED|95.0|-6.58|11.92||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 52|||11.92|-6.58|0.562
70919319|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21||||0.746|TWO_SIDED|95.0|-1.09|1.52||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 2|||1.52|-1.09|0.746
70919320|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13||||0.878|TWO_SIDED|95.0|-1.53|1.79||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 4|||1.79|-1.53|0.878
70919321|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.35||||0.644|TWO_SIDED|95.0|-1.15|1.85||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 8|||1.85|-1.15|0.644
70919322|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29||||0.715|TWO_SIDED|95.0|-1.86|1.28||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 12|||1.28|-1.86|0.715
70919323|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24||||0.803|TWO_SIDED|95.0|-1.62|2.1||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 18|||2.10|-1.62|0.803
70919324|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.32||||0.184|TWO_SIDED|95.0|-0.63|3.27||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 26|||3.27|-0.63|0.184
70919325|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.05||||0.102|TWO_SIDED|95.0|-0.42|4.52||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 39|||4.52|-0.42|0.102
71094020|NCT04950686|141695727|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.06||0.136|TWO_SIDED||||||Mixed Models Analysis|||||||0.136
70919326|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.44||||0.383|TWO_SIDED|95.0|-1.85|4.73||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 52|||4.73|-1.85|0.383
70919327|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.43||||0.607|TWO_SIDED|95.0|-1.2|2.06||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 2|||2.06|-1.20|0.607
70919328|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.67||||0.348|TWO_SIDED|95.0|-0.74|2.08||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 4|||2.08|-0.74|0.348
70919329|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.826|TWO_SIDED|95.0|-1.32|1.65||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 8|||1.65|-1.32|0.826
70919330|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.46||||0.588|TWO_SIDED|95.0|-2.13|1.21||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 12|||1.21|-2.13|0.588
70919331|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41||||0.585|TWO_SIDED|95.0|-1.08|1.91||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 18|||1.91|-1.08|0.585
70919332|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.82||||0.231|TWO_SIDED|95.0|-2.48|10.12||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 26|||10.12|-2.48|0.231
70919333|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.45||||0.24|TWO_SIDED|95.0|-0.99|3.89||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 39|||3.89|-0.99|0.240
70919334|NCT02299375|141329313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.17||||0.517|TWO_SIDED|95.0|-2.49|4.84||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 52|||4.84|-2.49|0.517
70919335|NCT02299375|141329320|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.67||||0.706|TWO_SIDED|95.0|-4.2|2.85||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Total, Week 12|||2.85|-4.20|0.706
70919336|NCT02299375|141329320|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.89||||0.694|TWO_SIDED|95.0|-3.58|5.36||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Total, Week 26|||5.36|-3.58|0.694
70919337|NCT02299375|141329320|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.83||||0.382|TWO_SIDED|95.0|-9.23|3.58||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Total, Week 39|||3.58|-9.23|0.382
70919338|NCT02299375|141329320|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49||||0.903|TWO_SIDED|95.0|-8.54|7.57||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Total, Week 52|||7.57|-8.54|0.903
70919339|NCT02299375|141329320|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.67||||0.481|TWO_SIDED|95.0|-6.33|2.99||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Symptoms, Week 12|||2.99|-6.33|0.481
70919340|NCT02299375|141329320|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.73||||0.793|TWO_SIDED|95.0|-4.79|6.25||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Symptoms, Week 26|||6.25|-4.79|0.793
70919341|NCT02299375|141329320|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.6||||0.421|TWO_SIDED|95.0|-12.45|5.26||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Symptoms, Week 39|||5.26|-12.45|0.421
70919342|NCT02299375|141329320|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.98||||0.162|TWO_SIDED|95.0|-19.35|3.4||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Symptoms, Week 52|||3.40|-19.35|0.162
70919343|NCT02299375|141329320|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.23||||0.592|TWO_SIDED|95.0|-3.31|5.78||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Activity, Week 12|||5.78|-3.31|0.592
70919344|NCT02299375|141329320|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.03||||0.704|TWO_SIDED|95.0|-4.31|6.36||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Activity, Week 26|||6.36|-4.31|0.704
70919345|NCT02299375|141329320|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.41||||0.546|TWO_SIDED|95.0|-10.32|5.5||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Activity, Week 39|||5.50|-10.32|0.546
70919346|NCT02299375|141329320|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.39||||0.35|TWO_SIDED|95.0|-5.06|13.84||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Activity, Week 52|||13.84|-5.06|0.350
70972133|NCT04074928|141450752|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 10% for the Day 29/57 SCR difference.|SCR difference|-14.87|||||TWO_SIDED|95.0|-19.61|-9.983||||||"Non-inferiority, B/Yamagata, SCR difference, Day 29/57~Non-inferiority of the immune response to the B/Yamagata vaccine strain by SCR difference (Comparator QIV SCR minus QIVc SCR)"||-9.983|-19.610|
70972134|NCT04074928|141450752|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 10% for the Day 29/57 SCR difference.|SCR difference|-5.96|||||TWO_SIDED|95.0|-10.327|-1.44||||||"Non-inferiority, B/Victoria, SCR difference, Day 29/57~Non-inferiority of the immune response to the B/Victoria vaccine strain by SCR difference (Comparator QIV SCR minus QIVc SCR)"||-1.440|-10.327|
70972135|NCT04074928|141450753|NON_INFERIORITY|The noninferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified noninferiority margin of 1.5 for the Day 29/57 GMT ratio (adjusted analysis).|GMT ratio|1.04|||||TWO_SIDED|95.0|0.927|1.16||||||"Non-inferiority, A/H3N2, GMT ratio, Day 29/57~Non-inferiority of the Day 29/57 immune response to the A/H3N2 vaccine strain calculated by GMT ratio (Comparator QIV GMT divided by QIVc GMT)"||1.160|0.927|
70972136|NCT04074928|141450754|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 10% for the Day 29/57 SCR difference.|SCR difference|3.13|||||TWO_SIDED|95.0|-1.443|7.812||||||"Non-inferiority, A/H3N2, SCR difference, Day 29/57~Non-inferiority of the immune response to the A/H3N2 vaccine strain by SCR difference (Comparator QIV SCR minus QIVc SCR)"||7.812|-1.443|
70972137|NCT04074928|141450755|OTHER|No formal statistical testing was planned for this secondary outcome measure.|GMT ratio|0.9|||||TWO_SIDED|95.0|0.79|1.024||||||A/H1N1, GMT ratio, Day 29/57||1.024|0.790|
71094021|NCT04950686|141695728|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.829|TWO_SIDED||||||Mixed Models Analysis|||||||0.829
70972138|NCT04074928|141450755|OTHER|No formal statistical testing was planned for this secondary outcome measure.|GMT ratio|1.08|||||TWO_SIDED|95.0|0.968|1.195||||||B/Yamagata, GMT ratio, Day 29/57||1.195|0.968|
70919347|NCT02299375|141329320|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.69||||0.411|TWO_SIDED|95.0|-5.75|2.37||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Impact, Week 12|||2.37|-5.75|0.411
70972139|NCT04074928|141450755|OTHER|No formal statistical testing was planned for this secondary outcome measure.|GMT ratio|1.09|||||TWO_SIDED|95.0|0.986|1.202||||||B/Victoria, GMT ratio, Day 29/57||1.202|0.986|
70972140|NCT04074928|141450756|OTHER|No formal statistical testing was planned for this secondary outcome measure.|SCR difference|-2.52|||||TWO_SIDED|95.0|-7.526|2.461||||||A/H1N1, SCR difference, Day 29/57||2.461|-7.526|
70972141|NCT04074928|141450756|OTHER|No formal statistical testing was planned for this secondary outcome measure.|SCR difference|-0.04|||||TWO_SIDED|95.0|-4.912|4.911||||||B/Yamagata, SCR difference, Day 29/57||4.911|-4.912|
70972142|NCT04074928|141450756|OTHER|No formal statistical testing was planned for this secondary outcome measure.|SCR difference|1.18|||||TWO_SIDED|95.0|-2.805|5.353||||||B/Victoria, SCR difference, Day 29/57||5.353|-2.805|
70972143|NCT04074928|141450757|OTHER|No formal statistical testing was planned for this secondary outcome measure.|GMT ratio|1.03|||||TWO_SIDED|95.0|0.914|1.165||||||A/H3N2, GMT ratio, Day 29/57||1.165|0.914|
70972144|NCT04074928|141450758|OTHER|No formal statistical testing was planned for this secondary outcome measure.|SCR difference|1.89|||||TWO_SIDED|95.0|-3.006|6.856||||||A/H3N2, SCR difference, Day 29/57||6.856|-3.006|
70972145|NCT02685709|141450766|NON_INFERIORITY|An assessment of NI was made by comparing the lower bound of the two-sided 95% confidence interval (CI) for the difference in biochemical control (octreotide capsules - SRLs) to a NI margin of -20%.|95% CI Stratified Miettinen & Nurminen|-19.9|||||TWO_SIDED|95.0|-19.9|0.5|||Stratified Miettinen & Nurminen (M&N)|||||0.5|-19.9|
70972146|NCT02685709|141450767|OTHER|||||||||||||||||"Secondary endpoints were analyzed without adjustment for multiplicity or predefined noninferiority margins and therefore were interpreted as exploratory.~This endpoint is descriptive with no formal statistical hypothesis testing."|The statistical analysis was based on the stratified Miettinen \& Nurminen (M\&N) method.|||
70972147|NCT02685709|141450768|OTHER||||||||||||||Clopper-Pearson method|||"Secondary endpoints were analyzed without adjustment for multiplicity or predefined noninferiority margins and therefore were interpreted as exploratory.~This endpoint is descriptive with no formal statistical hypothesis testing."|The statistical analysis was based on the stratified Miettinen \& Nurminen (M\&N) method.|||
70972148|NCT02685709|141450769|OTHER|||||||||||||Confidence interval was applied||||"Secondary endpoints were analyzed without adjustment for multiplicity or predefined noninferiority margins and therefore were interpreted as exploratory.~This endpoint is descriptive with no formal statistical hypothesis testing."|The statistical analysis was based on the stratified Miettinen \& Nurminen (M\&N) method.|||
70972149|NCT02685709|141450770|OTHER||||||||||||||Clopper-Pearson method|||Secondary endpoints were analyzed without adjustment for multiplicity or predefined noninferiority margins and therefore were interpreted as exploratory.|Based on this analysis 63.0% of patients in the octreotide capsule group and 51.4% of patients in the SRL injection group entered the Study Extension phase.|||
70972150|NCT02685709|141450771|OTHER|||||||||||||||||"Secondary endpoints were analyzed without adjustment for multiplicity or predefined noninferiority margins and therefore were interpreted as exploratory.~This endpoint is descriptive with no formal statistical hypothesis testing."|The mean change in IGF-1 from RCT Baseline to the end of the RCT phase was calculated using the Last Observation Carried Forward (LOCF) approach.|||
70972151|NCT02685709|141450772|OTHER|||||||||||||||||"Secondary endpoints were analyzed without adjustment for multiplicity or predefined noninferiority margins and therefore were interpreted as exploratory.~This endpoint is descriptive with no formal statistical hypothesis testing."|Estimates were obtained from an analysis of covariance (ANCOVA) for the mean integrated growth hormone (GH) change from baseline with explanatory factors of treatment group and baseline value.|||
70972152|NCT02685709|141450773|OTHER|||||||||||||||||This endpoint is descriptive with no formal statistical hypothesis testing|The week 26 value was used as the baseline value for the RCT phase. The denominator for the percentage was the number of subjects at each visit.|||
70972153|NCT02685709|141450774|OTHER|||||||||||||||||This endpoint is descriptive with no formal statistical hypothesis testing.|The week 26 value is used as the baseline value for the RCT phase. The denominator for the percentage was the number of subjects at each visit.|||
70972154|NCT02685709|141450775|OTHER|||||||||||||||||This endpoints is descriptive with no formal statistical hypothesis testing.|This sensitivity analysis was using the Full analysis set (FAS), where any patient who discontinued treatment early was imputed as non-responder.|||
70972155|NCT02685709|141450776|OTHER|||||||||||||||||This endpoints is descriptive with no formal statistical hypothesis testing|This sensitivity analysis was using the Full analysis set (FAS), where patient who were biochemically controlled at the RCT Baseline (week 26), and who discontinued treatment early was imputed as non-responder.|||
70972156|NCT02685709|141450777|OTHER||Proportion of patients|64.4|||||TWO_SIDED|95.0|56.0|72.1|||||Confidence Interval estimated using the Clopper-Pearson (Exact) method.||The proportion of patients biochemically controlled at the end of the Run-in phase was defined as IGF-1 \< 1.3 times ULN \[based on the average of week 24 and week 26\])|72.1|56|
70972157|NCT02685709|141450778|OTHER||Proportion of patients|66.4|||||TWO_SIDED|95.0|58.5|74.1||||||||74.1|58.5|
70972158|NCT02685709|141450779|OTHER||Proportion of patients|48.9|||||TWO_SIDED|95.0|38.7|59.1||||||||59.1|38.7|
70972159|NCT02685709|141450783|OTHER||||||||||||||||||The LSM change from baseline estimates are from a mixed model for repeated measures.|||
70972160|NCT04417894|141450812|SUPERIORITY||||||=|0.003|||||||Cochran-Mantel-Haenszel|||||||=0.0030
70972161|NCT04417894|141450813|SUPERIORITY||Difference|38.6|||<|0.0001|TWO_SIDED|95.0|24.06|53.15|||Mantel Haenszel|||||53.15|24.06|<0.0001
70972162|NCT00262873|141450834|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
70972163|NCT00262873|141450835|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
70972164|NCT00262873|141450836|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
70972165|NCT03440814|141450840|SUPERIORITY||Mean Difference (Final Values)|-1.67|STANDARD_ERROR_OF_MEAN|1.294||0.1983|TWO_SIDED|95.0|-4.24|0.89|||Mixed Models Analysis|MMRM analysis adjusted for baseline growth hormone use and HQ-CT total score. All available subject data were used with no imputation of missing data.|alpha=0.05 level of significance|||0.89|-4.24|0.1983
70972166|NCT03440814|141450841|SUPERIORITY|||||||0.0294|||||||Cochran-Mantel-Haenszel|Treatment groups were compared using CMH mean score test with modified ridit scores, stratified by the randomization stratification variables.||||||0.0294
70972167|NCT03440814|141450842|SUPERIORITY|||||||0.4089|||||||Cochran-Mantel-Haenszel|Treatment groups were compared using CMH mean score test with modified ridit scores, stratified by the randomization stratification variables.||||||0.4089
70972168|NCT03440814|141450843|SUPERIORITY||Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.458||0.0225|TWO_SIDED|95.0|-1.95|-0.15|||ANCOVA|ANCOVA adjusted for baseline body fat mass value as a covariate, and randomization stratification variables (as randomized) as factors.||||-0.15|-1.95|0.0225
70972169|NCT03440814|141450844|SUPERIORITY||Mean Difference (Final Values)|-3.13|STANDARD_ERROR_OF_MEAN|1.481||0.0369|TWO_SIDED|95.0|-6.06|-0.19|||Mixed Models Analysis|Linear mixed model for repeated measurements was used. All available data collected before the March 1, 2020 cutoff from each subject were included.|alpha=0.05 level of significance|||-0.19|-6.06|0.0369
70972170|NCT01318109|141450860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.751|||||TWO_SIDED|95.0|-0.923|-0.579||||||||-0.579|-0.923|
70972171|NCT01318109|141450860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.858|||||TWO_SIDED|95.0|-1.019|-0.697||||||||-0.697|-1.019|
70972172|NCT01318109|141450861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.191|||||TWO_SIDED|95.0|-0.247|-0.135||||||||-0.135|-0.247|
70972173|NCT01318109|141450861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.192|||||TWO_SIDED|95.0|-0.242|-0.143||||||||-0.143|-0.242|
70972174|NCT01318109|141450862|SUPERIORITY_OR_OTHER||Hazard Ratio, log|-0.386|||||TWO_SIDED|95.0|-0.469|-0.303||||||||-0.303|-0.469|
70972175|NCT01318109|141450862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.403|||||TWO_SIDED|95.0|-0.484|-0.323||||||||-0.323|-0.484|
70972176|NCT01318109|141450863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.621|||||TWO_SIDED|95.0|-0.757|-0.486||||||||-0.486|-0.757|
70972177|NCT01318109|141450863|SUPERIORITY_OR_OTHER||Hazard Ratio, log|-0.692|||||TWO_SIDED|95.0|-0.814|-0.569||||||||-0.569|-0.814|
70972178|NCT01318109|141450864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.26|||||TWO_SIDED|95.0|-26.12|-12.4||||||||-12.40|-26.12|
70972179|NCT01318109|141450864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.27|||||TWO_SIDED|95.0|-30.43|-16.12||||||||-16.12|-30.43|
70972180|NCT01318109|141450865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.6|||||TWO_SIDED|95.0|-24.54|-10.66||||||||-10.66|-24.54|
70972181|NCT01318109|141450865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.35|||||TWO_SIDED|95.0|-28.32|-14.39||||||||-14.39|-28.32|
71094022|NCT04950686|141695728|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.748|TWO_SIDED||||||Mixed Models Analysis|||||||0.748
70972182|NCT01318109|141450866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.87|||||TWO_SIDED|95.0|-25.95|-11.79||||||||-11.79|-25.95|
71094023|NCT04950686|141695729|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.12||0.49|TWO_SIDED||||||Mixed Models Analysis|||||||0.490
70972183|NCT01318109|141450866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.16|||||TWO_SIDED|95.0|-25.43|-10.9||||||||-10.90|-25.43|
70972184|NCT01318109|141450867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.24|||||TWO_SIDED|95.0|-26.32|-10.16||||||||-10.16|-26.32|
70972185|NCT01318109|141450867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.38|||||TWO_SIDED|95.0|-30.87|-13.88||||||||-13.88|-30.87|
70972186|NCT01318109|141450868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.89|||||TWO_SIDED|95.0|-20.14|2.37||||||||2.37|-20.14|
70972187|NCT01318109|141450868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.41|||||TWO_SIDED|95.0|-16.34|3.52||||||||3.52|-16.34|
70972188|NCT01411085|141450876|SUPERIORITY||Mean Difference (Final Values)|7.0||||0.317|TWO_SIDED||||||t-test, 2 sided|||The assessment was between baseline and values for last 8 weeks.||||0.317
70972189|NCT02193074|141450877|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentages|50.68|||<|0.0001|TWO_SIDED|95.0|31.81|66.48|||Fisher Exact||exact unconditional confidence interval|||66.48|31.81|< 0.0001
70972190|NCT02193074|141450878|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0046|||||||Log Rank|Based on log-rank test stratified by disease duration.||||||0.0046
70972191|NCT02193074|141450878|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.53||||0.0164|TWO_SIDED|95.0|0.3156|0.8902|||Cox proportional hazards model|Based on Cox proportional hazards model adjusted for each subject's disease duration at screening.||||0.8902|0.3156|0.0164
70972192|NCT02193074|141450879|SUPERIORITY_OR_OTHER_LEGACY||DIfference in percentages|68.53|||<|0.0001|TWO_SIDED|95.0|51.27|81.99|||Fisher Exact|||||81.99|51.27|< 0.0001
70972193|NCT02193074|141450880|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0041|||||||Log Rank|Based on log-rank test stratified by disease duration (primary analysis).||||||0.0041
70972194|NCT02193074|141450880|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.372||||0.0082|TWO_SIDED|95.0|0.1787|0.7745|||Cox proportional hazards|Based on Cox proportional hazards model adjusted for each subject's disease duration at screening (sensitivity analysis).||||0.7745|0.1787|0.0082
70972195|NCT02193074|141450882|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentages|30.21||||0.0004|TWO_SIDED|95.0|10.35|48.09|||Fisher Exact|||||48.09|10.35|0.0004
70972196|NCT02193074|141450883|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||Log Rank|||||||0.0003
70972197|NCT02193074|141450883|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.24||||0.0014|TWO_SIDED|95.0|0.1002|0.5753|||Cox proportional hazards|Based on Cox proportional hazards model adjusted for each subject's disease duration at screening.||||0.5753|0.1002|0.0014
70972198|NCT02193074|141450884|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3953|||||||Log Rank|||||||0.3953
71094024|NCT04950686|141695729|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.13||0.831|TWO_SIDED||||||Mixed Models Analysis|||||||0.831
70972199|NCT02193074|141450884|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.844||||0.6268|TWO_SIDED|95.0|0.427|1.6698|||Cox proportional hazards|Based on Cox proportional hazards model adjusted for each subject's disease duration at screening.||||1.6698|0.4270|0.6268
70972200|NCT01534533|141450891|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori threshold for statistical significance was 0.05 (two sides)|Chi-squared|||"The null hypothesis was no group difference"||||>0.05
70972201|NCT01534533|141450892|SUPERIORITY_OR_OTHER|||||||0.992||95.0||||The a priori threshold for statistical significance was 0.05 (two sides)|ANOVA|||"The null hypothesis was no group difference"||||0.992
70972202|NCT01534533|141450893|SUPERIORITY_OR_OTHER|||||||0.672||95.0||||The a priori threshold for statistical significance was 0.05 (two sides)|ANOVA|||"The null hypothesis was no group difference"||||0.672
70972203|NCT01534533|141450894|SUPERIORITY_OR_OTHER|||||||0.402||95.0||||The a priori threshold for statistical significance was 0.05 (two sides)|ANOVA|||"The null hypothesis was no group difference"||||0.402
70972204|NCT01534533|141450895|SUPERIORITY_OR_OTHER|||||||0.636||95.0||||The a priori threshold for statistical significance was 0.05 (two sides)|ANOVA|||"The null hypothesis was no group difference"||||0.636
70972205|NCT03036293|141450899|SUPERIORITY||Mean Difference (Final Values)|1.56||||0.0055|TWO_SIDED|98.33|0.217|2.91|||ANCOVA|Baseline score used as covariate||Mean score differences (begin-end) were compared||2.91|0.217|0.0055
70972206|NCT03036293|141450899|SUPERIORITY||Mean Difference (Final Values)|2.56|||<|0.0001|TWO_SIDED|98.33|1.1|3.96|||ANCOVA|Baseline score used as covariate. Yeo-Johnson transformation with λ=1,09 was applied. Statistical inference performed for transformed values.|estimate and CL are backtransformed|Mean score differences (begin-end) were compared||3.96|1.1|<0.0001
70972207|NCT03036293|141450899|EQUIVALENCE|equivalence limits were prespecified as \[-2.763; 2.763\]|Mean Difference (Net)|0.89||||0.0008|TWO_SIDED|98.33|-0.64|2.33|||ANCOVA|Baseline score used as covariate||Mean score differences (begin-end) were compared||2.33|-0.64|0.0008
70972208|NCT03036293|141450900|SUPERIORITY||Mean Difference (Net)|0.6||||0.08|TWO_SIDED|95.0|-0.08|1.54|||ANCOVA|Baseline score used as covariate||Mean score differences (begin-end) were compared||1.54|-0.08|0.08
70972209|NCT03036293|141450900|SUPERIORITY||Mean Difference (Net)|0.76||||0.044|TWO_SIDED|95.0|0.02|1.66|||ANCOVA|Baseline score used as covariate||Mean score differences (begin-end) were compared||1.66|0.02|0.044
70972210|NCT03036293|141450901|SUPERIORITY||Mean Difference (Net)|0.69||||0.21|TWO_SIDED|95.0|-0.4|1.78|||ANCOVA|Baseline score used as covariate||Mean score differences (begin-end) were compared||1.78|-0.4|0.21
70972211|NCT03036293|141450901|SUPERIORITY||Mean Difference (Net)|1.19||||0.027|TWO_SIDED|95.0|0.14|2.26|||ANCOVA|Baseline score used as covariate||Mean score differences (begin-end) were compared||2.26|0.14|0.027
70972212|NCT03036293|141450902|SUPERIORITY||Odds Ratio (OR)|1.36||||0.065|TWO_SIDED|95.0|0.98|1.89|||Cochran-Mantel-Haenszel||Bigger OR is better|Common OR of event analysis||1.89|0.98|0.065
70972213|NCT03036293|141450902|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0015|TWO_SIDED|95.0|1.22|2.33|||Cochran-Mantel-Haenszel||Bigger OR is better|Common OR of event analysis||2.33|1.22|0.0015
70972214|NCT03036293|141450902|SUPERIORITY|||||||0.7|||||||Fisher Exact|||Week 4 frequencies comparison||||0.7
70972215|NCT03036293|141450902|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 8 frequencies comparison||||1
70972216|NCT03036293|141450902|SUPERIORITY|||||||0.01|||||||Fisher Exact|||Week 12 frequencies comparison||||0.01
70972217|NCT03036293|141450902|SUPERIORITY|||||||0.57|||||||Fisher Exact|||Week 4 frequencies comparison||||0.57
70972218|NCT03036293|141450902|SUPERIORITY|||||||0.25|||||||Fisher Exact|||Week 8 frequencies comparison||||0.25
70972219|NCT03036293|141450902|SUPERIORITY|||||||0.001|||||||Fisher Exact|||Week 12 frequencies comparison||||0.001
70972220|NCT03036293|141450903|SUPERIORITY||Odds Ratio (OR)|0.88||||0.46|TWO_SIDED|95.0|0.64|1.23|||Cochran-Mantel-Haenszel||Bigger OR is better|Common OR of event analysis||1.23|0.64|0.46
70972221|NCT03036293|141450903|SUPERIORITY||Odds Ratio (OR)|1.27||||0.17|TWO_SIDED|95.0|0.9|1.79|||Cochran-Mantel-Haenszel||Bigger OR is better|Common OR of event analysis||1.79|0.9|0.17
70972222|NCT03036293|141450903|SUPERIORITY|||||||0.38|||||||Fisher Exact|||Week 4 frequencies comparison||||0.38
71094025|NCT04950686|141695730|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.1||0.35|TWO_SIDED||||||Mixed Models Analysis|||||||0.350
70972223|NCT03036293|141450903|SUPERIORITY|||||||0.67|||||||Fisher Exact|||Week 8 frequencies comparison||||0.67
71094026|NCT04950686|141695730|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.1||0.235|TWO_SIDED||||||Mixed Models Analysis|||||||0.235
70972224|NCT03036293|141450903|SUPERIORITY|||||||0.85|||||||Fisher Exact|||Week 12 frequencies comparison||||0.85
70972225|NCT03036293|141450903|SUPERIORITY|||||||0.71|||||||Fisher Exact|||Week 4 frequencies comparison||||0.71
70972226|NCT03036293|141450903|SUPERIORITY|||||||0.29|||||||Fisher Exact|||Week 8 frequencies comparison||||0.29
70972227|NCT03036293|141450903|SUPERIORITY|||||||0.007|||||||Fisher Exact|||Week 12 frequencies comparison||||0.007
70972228|NCT03036293|141450904|SUPERIORITY||Median Difference (Net)|0.00002||||0.314|TWO_SIDED|95.0|-0.00002|0.33|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimator for location difference provided|Median changes (begin-end) within groups are compared||0.33|-0.00002|0.314
70972229|NCT03036293|141450904|SUPERIORITY||Median Difference (Net)|0.0||||0.031|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimator for location difference provided|Median changes (begin-end) within groups are compared||1|0|0.031
70972230|NCT03036293|141450905|SUPERIORITY||Median Difference (Net)|-0.00001||||0.0021|TWO_SIDED|95.0|-3.0|-0.00001|||Wilcoxon (Mann-Whitney)||Lower is better|||-0.00001|-3|0.0021
70972231|NCT03036293|141450905|SUPERIORITY||Median Difference (Net)|-0.00002||||0.0056|TWO_SIDED|95.0|-1.0|-0.00002|||Wilcoxon (Mann-Whitney)||Lower is better|||-0.00002|-1|0.0056
70972232|NCT00691483|141450906|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.03|||<|0.0001|TWO_SIDED|95.0|3.8|9.56||To preserve the type I family-wise error rate of 0.05, a step-down procedure to be used for the analysis of CA for Week 9 through Week 12 and the CA for Week 9 through Week 24.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Sample size to be based on a continuity-corrected Chi-square 2-sided test with a 0.05 significance level and a 3:1 randomization ratio of Varenicline to placebo. 652 subjects to provide \>=90% power to detect Varenicline versus placebo differences in primary and key secondary efficacy endpoints (assuming placebo CA rates of 0.24 \[Weeks 9-12\] and 0.18 \[Weeks 9-24\] and Varenicline CA rates of 0.46 \[Weeks 9-12\] and 0.31 \[Weeks 9-24\]) (odds ratio of \>=2.67 \[Weeks 9-12\] and \>=2.10 \[Weeks 9-24\]).||9.56|3.80|<0.0001
70972233|NCT00691483|141450907|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.45|||<|0.0001|TWO_SIDED|95.0|2.62|7.55||To preserve the type I family-wise error rate of 0.05, a step-down procedure to be used for the analysis of CA for Week 9 through Week 12 and the CA for Week 9 through Week 24.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Sample size to be based on a continuity-corrected Chi-square 2-sided test with a 0.05 significance level and a 3:1 randomization ratio of Varenicline to placebo. 652 subjects to provide \>=90% power to detect Varenicline versus placebo differences in primary and key secondary efficacy endpoints (assuming placebo CA rates of 0.24 \[Weeks 9-12\] and 0.18 \[Weeks 9-24\] and Varenicline CA rates of 0.46 \[Weeks 9-12\] and 0.31 \[Weeks 9-24\]) (odds ratio of \>=2.67 \[Weeks 9-12\] and \>=2.10 \[Weeks 9-24\]).||7.55|2.62|<0.0001
70972234|NCT00691483|141450908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.91|||<|0.0001|TWO_SIDED|95.0|2.96|8.13||A 0.05 level of significance without adjustment for multiplicity.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Statistical testing to be 2-sided and use a 0.05 level of significance. Confidence intervals to have a 95% confidence level. Statistical significance to be declared unless a p-value \>0.05 was obtained.||8.13|2.96|<0.0001
70972235|NCT00691483|141450909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.66|||<|0.0001|TWO_SIDED|95.0|3.66|8.75||A 0.05 level of significance without adjustment for multiplicity.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Week 12. Statistical testing to be 2-sided and use a 0.05 level of significance. Confidence intervals to have a 95% confidence level. Statistical significance to be declared unless a p-value \>0.05 was obtained.||8.75|3.66|<0.0001
70972236|NCT00691483|141450909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.12|||<|0.0001|TWO_SIDED|95.0|2.58|6.58||A 0.05 level of significance without adjustment for multiplicity.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Week 24. Statistical testing to be 2-sided and use a 0.05 level of significance. Confidence intervals to have a 95% confidence level. Statistical significance to be declared unless a p-value \>0.05 was obtained.||6.58|2.58|<0.0001
70972237|NCT00691483|141450910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.14|||<|0.0001|TWO_SIDED|95.0|2.58|6.67||A 0.05 level of significance without adjustment for multiplicity.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Statistical testing to be 2-sided and use a 0.05 level of significance. Confidence intervals to have a 95% confidence level. Statistical significance to be declared unless a p-value \>0.05 was obtained.||6.67|2.58|<0.0001
70972238|NCT00439946|141450912|SUPERIORITY_OR_OTHER_LEGACY|||||||0.84||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.84
70972239|NCT00439946|141450913|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
70972240|NCT00439946|141450914|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
70972241|NCT00439946|141450915|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||0.50
70972242|NCT00439946|141450916|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||1.00
70972243|NCT00439946|141450917|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||0.50
70972244|NCT00439946|141450918|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||1.0
71094027|NCT04950686|141695731|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.1||0.682|TWO_SIDED||||||Mixed Models Analysis|||||||0.682
70972245|NCT00439946|141450919|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||0.75
70972246|NCT00439946|141450920|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||1.0
70972247|NCT00439946|141450921|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||1.00
70972248|NCT00439946|141450922|SUPERIORITY_OR_OTHER_LEGACY|||||||0.95||95.0||||p-value for: Gather/set-up|Wilcoxon signed rank|||Changes in mean times between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.95
70972249|NCT00439946|141450922|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0||||p-value for: Prepare drug|Wilcoxon signed rank|||Changes in mean times between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.02
70972250|NCT00439946|141450922|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||95.0||||p-value for: Connect drug|Wilcoxon signed rank|||Changes in mean times between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.20
70972251|NCT00439946|141450922|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48||95.0||||p-value for: Change dressing|Wilcoxon signed rank|||Changes in mean times between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.48
70972252|NCT00439946|141450922|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||95.0||||p-value for: Total time|Wilcoxon signed rank|||Changes in mean times between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.11
70972253|NCT00439946|141450923|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||95.0||||p-value for: CAMPHOR Symptom Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.31
70972254|NCT00439946|141450923|SUPERIORITY_OR_OTHER_LEGACY|||||||0.84||95.0||||p-value for CAMPHOR Activity Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.84
71094028|NCT04950686|141695731|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.11||0.373|TWO_SIDED||||||Mixed Models Analysis|||||||0.373
71094029|NCT04950686|141695732|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.25||||0.242|TWO_SIDED|95.0|0.24|6.63|||Mixed Models Analysis|||||6.63|0.24|0.242
70919348|NCT02299375|141329320|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35||||0.896|TWO_SIDED|95.0|-5.67|4.97||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Impact, Week 26|||4.97|-5.67|0.896
70919349|NCT02299375|141329320|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.21||||0.559|TWO_SIDED|95.0|-9.73|5.3||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Impact, Week 39|||5.30|-9.73|0.559
70919350|NCT02299375|141329320|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.29||||0.809|TWO_SIDED|95.0|-12.19|9.6||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Impact, Week 52|||9.60|-12.19|0.809
70919351|NCT00704184|141329332|SUPERIORITY_OR_OTHER||Adjusted difference in %|69.3|||<|0.001|TWO_SIDED|95.0|40.3|86.7|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of placebo responders (5.3%) and stratifies by HCV genotype (1a vs. non-1a).|||86.7|40.3|<0.001
70972255|NCT00439946|141450923|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0||||p-value for CAMPHOR Quality of Life Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.03
70972256|NCT00439946|141450923|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22||95.0||||p-value for CAMPHOR Total Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.22
70972257|NCT00439946|141450924|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0||||p-value for TSQM Effectiveness Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.55
70972258|NCT00439946|141450924|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0||||p-value for TSQM Side-Effects Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.50
71094030|NCT04950686|141695732|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.78||||0.207|TWO_SIDED|95.0|0.11|5.72|||Mixed Models Analysis|||||5.72|0.11|0.207
70919352|NCT00704184|141329332|SUPERIORITY_OR_OTHER||Adjusted difference in %|73.6|||<|0.001|TWO_SIDED|95.0|46.0|88.6|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of placebo responders (5.3%) and stratifies by HCV genotype (1a vs. non-1a).|||88.6|46.0|<0.001
70919353|NCT00704184|141329332|SUPERIORITY_OR_OTHER||Adjusted difference in %|63.3|||<|0.001|TWO_SIDED|95.0|32.8|82.7|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of placebo responders (5.3%) and stratifies by HCV genotype (1a vs. non-1a).|||82.7|32.8|<0.001
70972259|NCT00439946|141450924|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0||||p-value for TSQM Convenience Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.01
70972260|NCT00439946|141450924|SUPERIORITY_OR_OTHER_LEGACY|||||||0.52||95.0||||p-value for TSQM Global Satisfaction Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.52
70972261|NCT00049673|141450929|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.18|TWO_SIDED|95.0|0.53|1.14|||Log Rank|||||1.14|0.53|0.18
70972262|NCT00049673|141450930|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.0001|TWO_SIDED|95.0|0.43|0.73|||Log Rank|||||0.73|0.43|0.0001
70972263|NCT02475681|141450932|SUPERIORITY||Hazard Ratio (HR)|0.1|||<|0.0001|TWO_SIDED|95.0|0.06|0.17|||Log Rank|Stratified by randomization stratification factors as recorded in IXRS||The primary test to compare PFS between treatment arms was the two-sided log-rank test, stratified by randomization stratification factors. The estimate of the HR (Arm B/Arm A) and the corresponding 95% CI was computed using a Cox proportional hazards model stratified by randomization stratification factors. Randomization stratification factors were based on the data recorded in IXRS.||0.17|0.06|<0.0001
70919354|NCT00704184|141329332|SUPERIORITY_OR_OTHER||Adjusted difference in %|77.8|||<|0.001|TWO_SIDED|95.0|49.2|91.3|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of placebo responders (5.3) and stratifies by HCV genotype (1a vs. non-1a).|||91.3|49.2|<0.001
70972264|NCT02475681|141450933|SUPERIORITY||Hazard Ratio (HR)|0.2|||<|0.0001|TWO_SIDED|95.0|0.13|0.3|||Log Rank|Stratified by randomization stratification factors as recorded in IXRS||The test to compare PFS between treatment Arms A and C was the two-sided log-rank test, stratified by randomization stratification factors. The estimate of the HR and the corresponding 95% CI was computed using a Cox proportional hazards model stratified by randomization stratification factors. Randomization stratification factors were based on the data recorded in IXRS.||0.30|0.13|<0.0001
70972265|NCT02475681|141450934|SUPERIORITY||Risk Difference (RD)|15.3|||<|0.0001|TWO_SIDED|95.0|8.3|22.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenzel test with adjustment for randomization stratification factors as recorded in IXRS||||22.3|8.3|<0.0001
70972266|NCT02475681|141450934|SUPERIORITY||Risk Difference (RD)|6.9||||0.0763|TWO_SIDED|95.0|-1.0|14.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenzel test with adjustment for randomization stratification factors as recorded in IXRS.||||14.9|-1.0|0.0763
70972267|NCT02475681|141450935|SUPERIORITY||Hazard Ratio (HR)|0.14|||<|0.0001|TWO_SIDED|95.0|0.08|0.26|||Log Rank|Stratified by randomization stratification factors as recorded in IXRS||The test to compare TTNT between treatment Arms A versus B and Arms A versus C was the two-sided log-rank test, stratified by randomization stratification factors. The estimate of the HR and the corresponding 95% CI was computed using a Cox proportional hazards model stratified by randomization stratification factors. Randomization stratification factors were based on the data recorded in IXRS.||0.26|0.08|<0.0001
70972268|NCT02475681|141450935|SUPERIORITY||Hazard Ratio (HR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.15|0.4||P-value based on stratified by randomization stratification factors as recorded in IXRS|Log Rank|Stratified by randomization stratification factors as recorded in IXRS||||0.40|0.15|<0.0001
70972269|NCT02475681|141450936|SUPERIORITY||Hazard Ratio (HR)|0.47||||0.0577|TWO_SIDED|95.0|0.21|1.06|||Log Rank|Stratified by randomization stratification factors as recorded in IXRS||The test to compare overall survival between treatment Arms A versus B and Arms A versus C was the two-sided log-rank test, stratified by randomization stratification factors. The estimate of the HR and the corresponding 95% CI was computed using a Cox proportional hazards model stratified by randomization stratification factors. Randomization stratification factors were based on the data recorded in IXRS.||1.06|0.21|0.0577
70972270|NCT02475681|141450936|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.1556|TWO_SIDED|95.0|0.28|1.27|||Log Rank|Stratified by randomization stratification factors as recorded in IXRS||||1.27|0.28|0.1556
70972271|NCT03325673|141450972|SUPERIORITY|||||||0.116|||||||Independent t-test|||||||0.116
70972272|NCT03325673|141450973|SUPERIORITY|||||||0.468|||||||t-test, 2 sided|||Insertion||||0.468
70972273|NCT03325673|141450973|SUPERIORITY|||||||0.235|||||||t-test, 2 sided|||After 2 hours||||0.235
70972274|NCT03325673|141450973|SUPERIORITY|||||||0.152|||||||t-test, 2 sided|||End of Day||||0.152
71094031|NCT04950686|141695733|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.88||||0.576|TWO_SIDED|95.0|0.51|1.52|||Mixed Models Analysis|||||1.52|0.51|0.576
70972275|NCT03325673|141450974|SUPERIORITY|||||||0.488|||||||t-test, 2 sided|||||||0.488
70972276|NCT03325673|141450975|SUPERIORITY|||||||0.072|||||||t-test, 2 sided|||||||0.072
71094032|NCT04950686|141695733|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.97||||0.888|TWO_SIDED|95.0|0.46|2.03|||Mixed Models Analysis|||||2.03|0.46|0.888
70972277|NCT00590590|141450976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||||||||||Ha: Drug 1 \< Drug 2||||
70972278|NCT00590590|141450976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||||||||||||Ha: Drug 1 \< Placebo||||
70972279|NCT00590590|141450976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||||||||||||Ha: Drug 2 \< Placebo||||
70972280|NCT00590590|141450977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||||||||||||Ha: Drug 1 \< Drug 2||||
70972281|NCT00590590|141450977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||||||||||||Ha: Drug 1 \< Placebo||||
71094033|NCT04950686|141695734|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.87||||0.467|TWO_SIDED|95.0|0.22|3.45|||Mixed Models Analysis|||||3.45|0.22|0.467
70972282|NCT00590590|141450977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||||||||||||Ha: Drug 2 \< Placebo||||
70972283|NCT00590590|141450978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||||||||||||Ha: Drug 1 \< Drug 2||||
70972284|NCT00590590|141450978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7||||||||||||||Ha: Drug 1 \< Placebo||||
70972285|NCT00590590|141450978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.8||||||||||||||Ha: Drug 2 \< Placebo||||
70972286|NCT00590590|141450979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.3||||||||||||||Ha: Drug 1 \< Drug 2||||
70972287|NCT00590590|141450979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.0||||||||||||||Ha: Drug 1 \< Placebo||||
70972288|NCT00590590|141450979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||||||||||||Ha: Drug 2 \< Placebo||||
70972289|NCT00590590|141450980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1||||||||||||||Ha: Drug 1 \< Drug 2||||
70972290|NCT00590590|141450980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9||||||||||||||Ha: Drug 1 \< Placebo||||
70972291|NCT00590590|141450980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0||||||||||||||Ha: Drug 2 \< Placebo||||
70972292|NCT00590590|141450981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||||||||||||Ha: Drug 1 \< Drug 2||||
70972293|NCT00590590|141450981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||||||||||||Ha: Drug 1 \< Placebo||||
70972294|NCT00590590|141450981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||||||||||||Ha: Drug 2 \< Placebo||||
70972295|NCT02025426|141450982|OTHER|||||||0.547|||||||Kruskal-Wallis|||||||0.547
70972296|NCT02025426|141450984|OTHER|||||||0.925|||||||Kruskal-Wallis|||||||0.925
70972297|NCT02025426|141450985|OTHER|||||||0.498|||||||Kruskal-Wallis|||||||0.498
70972298|NCT02025426|141450986|OTHER|||||||0.201|||||||Kruskal-Wallis|||||||0.201
70972299|NCT02025426|141450987|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
70972300|NCT02025426|141450988|OTHER|||||||0.962|||||||Fisher Exact|||||||0.962
70972301|NCT02025426|141450989|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
70972302|NCT00132132|141450990|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||t-test, 2 sided|This analysis is the per protocol unadjusted value||||||0.03
70972303|NCT00132132|141450990|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||t-test, 2 sided|Age adjusted per protocol||||||0.14
70972304|NCT00132132|141450990|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||t-test, 2 sided|Per protocol adjusted for age and paternal education. Given the small number of participants with complete data, this model may be overfit.||||||0.006
70972305|NCT00132132|141450991|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Chi-squared|||||||0.02
70972306|NCT00452699|141451006|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.11|||<|0.001||95.0|0.07|0.15|||ANCOVA|||||0.15|0.07|<0.001
70972307|NCT00326898|141451010|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.02||||0.8|TWO_SIDED|97.5|0.85|1.23|||Stratified logrank test|Stratified logrank test was performed. Stratification factors include basis of risk group, histologic subtype, performance status and type of surgery.||||1.23|0.85|0.80
70972308|NCT00326898|141451010|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.72|TWO_SIDED|97.5|0.8|1.17|||Stratified logrank test|Stratified logrank test was performed. Stratification factors include basis of risk group, histologic subtype, performance status and type of surgery.||||1.17|0.80|0.72
71094034|NCT04950686|141695734|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.97||||0.888|TWO_SIDED|95.0|0.46|2.03|||Mixed Models Analysis|||||2.03|0.46|0.888
70972309|NCT00326898|141451011|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|97.5|0.9|1.52|||||Hazard ratio was estimated using stratified proportional hazards model with Arm C (placebo arm) as the reference group.|||1.52|0.90|
71094035|NCT04950686|141695735|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.07||0.0003|TWO_SIDED||||||Mixed Models Analysis|||||||0.0003
71094036|NCT04950686|141695735|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.09||0.432|TWO_SIDED||||||Mixed Models Analysis|||||||0.432
70972310|NCT00326898|141451011|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|97.5|0.75|1.28|||||Hazard ratio was estimated using stratified proportional hazards model with Arm C (placebo arm) as the reference group.|||1.28|0.75|
70972311|NCT01166230|141451060|SUPERIORITY_OR_OTHER|||||||0.141|||||||Fisher Exact|||||||0.141
70972312|NCT01166230|141451061|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.041
70972313|NCT01166230|141451062|SUPERIORITY_OR_OTHER|||||||0.056|TWO_SIDED|99.0|||||Wilcoxon (Mann-Whitney)|||||||0.056
70972314|NCT02111564|141451095|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.136|TWO_SIDED|95.0|0.52|1.09|||Cox proportional hazards model|||||1.09|0.52|0.136
70972315|NCT02111564|141451096|SUPERIORITY||Hazard Ratio (HR)|1.88||||0.124|TWO_SIDED|95.0|0.84|4.23|||Cox proportional hazards model|||||4.23|0.84|0.124
70972316|NCT02111564|141451097|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.751|TWO_SIDED|95.0|0.62|1.42|||Cox proportional hazards model|||||1.42|0.62|0.751
70972317|NCT02111564|141451098|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.023|TWO_SIDED|95.0|0.22|0.89|||Cox proportional hazards model|||||0.89|0.22|0.023
70972318|NCT02111564|141451099|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.033|TWO_SIDED|95.0|0.54|0.97|||Cox proportional hazards model|||||0.97|0.54|0.033
70972319|NCT02111564|141451100|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.073|TWO_SIDED|95.0|0.6|1.02|||Cox proportional hazards model|||||1.02|0.60|0.073
70972320|NCT02111564|141451101|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.156|TWO_SIDED|95.0|0.58|1.09|||Cox proportional hazards model|||||1.09|0.58|0.156
70972321|NCT02354703|141451103|SUPERIORITY|||||||0.94||||||a priori significance P\<0.05|Kruskal-Wallis|adjusted for baseline value||||||0.94
70972322|NCT02354703|141451104|SUPERIORITY|||||||1||||||a priori significance is P\<0.05|Chi-squared|adjusted for baseline value||||||1.00
70972323|NCT02354703|141451105|SUPERIORITY|||||||0.73||||||a priori threshold is P\<0.05|Kruskal-Wallis|adjusted for baseline value||||||0.73
70972324|NCT03468309|141451115|SUPERIORITY|T-test was used to compare means at baseline and 12-weeks|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70972325|NCT03468309|141451116|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70972326|NCT03468309|141451117|SUPERIORITY||||||<|0.05|||||||ANOVA|Assumption of sphericity had been violated X2(2)=13.61, p\<.01 so Huynh-Feldt correction was used||||||<0.05
70972327|NCT03468309|141451118|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
70972328|NCT04589988|141451163|SUPERIORITY|||||||0.068||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, and depression score at baseline.||||0.068
70972329|NCT04589988|141451164|SUPERIORITY|||||||0.063||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, and depression score at baseline.||||0.063
70972330|NCT04589988|141451165|SUPERIORITY|||||||0.724||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, and depression score at baseline.||||0.724
70972331|NCT04589988|141451166|SUPERIORITY|||||||0.447||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, and depression score at baseline.||||0.447
70972332|NCT04589988|141451167|SUPERIORITY|||||||0.696||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, work status, and depression score at baseline.||||0.696
70972333|NCT04589988|141451168|SUPERIORITY|||||||0.798||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, and depression score at baseline.||||0.798
70972334|NCT04589988|141451169|SUPERIORITY|||||||0.135||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, and depression score at baseline.||||0.135
70972335|NCT04589988|141451170|SUPERIORITY|||||||0.291||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, work status, and depression score at baseline.||||0.291
70972336|NCT04589988|141451171|SUPERIORITY||Incidence rate ratio|0.83||||0.631|TWO_SIDED|95.0|0.4|1.76|||Negative binomial regression||IRR reflects REBIL intervention group versus control group.|Fall rates were compared between REBIL and control groups using negative binomial regression. The model adjusted for age, sex, ace, and depression score at baseline. The null hypothesis was that fall rates do not differ between groups.||1.76|0.40|0.631
70972337|NCT02112370|141451176|SUPERIORITY_OR_OTHER|||||||0.008||||||threshold p value for significance \< 0.05|t-test, 2 sided|||Swallowing difficulty||||0.008
70972338|NCT02112370|141451176|SUPERIORITY_OR_OTHER|||||||0.016||||||threshold p value for significance \< 0.05|t-test, 2 sided|||Anterior neck pain||||0.016
70972339|NCT02112370|141451176|SUPERIORITY_OR_OTHER|||||||0.019||||||threshold p value for significance \< 0.05|t-test, 2 sided|||Right chest pain||||0.019
70919355|NCT00704184|141329335|SUPERIORITY_OR_OTHER||Adjusted difference|11.2|||||TWO_SIDED|95.0|-9.7|33.8|||||Adjusted difference subtracts the percentage of placebo responders (88.9%) and stratifies by HCV genotype (1a vs. non-1a).|||33.8|-9.7|
70919356|NCT00704184|141329335|SUPERIORITY_OR_OTHER||Adjusted difference|10.8|||||TWO_SIDED|95.0|-7.6|33.2|||||Adjusted difference subtracts the percentage of placebo responders (88.9%) and stratifies by HCV genotype (1a vs. non-1a).|||33.2|-7.6|
70919357|NCT00704184|141329335|SUPERIORITY_OR_OTHER||Adjusted difference|11.2|||||TWO_SIDED|95.0|-9.7|33.8|||||Adjusted difference subtracts the percentage of placebo responders (88.9%) and stratifies by HCV genotype (1a vs. non-1a).|||33.8|-9.7|
70919358|NCT00704184|141329335|SUPERIORITY_OR_OTHER||Adjusted difference|5.4|||||TWO_SIDED|95.0|-16.5|28.4|||||Adjusted difference subtracts the percentage of placebo responders (88.9%) and stratifies by HCV genotype (1a vs. non-1a).|||28.4|-16.5|
70919359|NCT00704184|141329336|SUPERIORITY_OR_OTHER||Adjusted difference|16.9|||||TWO_SIDED|95.0|-4.0|40.2|||||Adjusted difference subtracts the percentage of placebo responders (83.3%) and stratifies by HCV genotype (1a vs. non-1a).|||40.2|-4.0|
70972340|NCT02112370|141451176|SUPERIORITY_OR_OTHER|||||||0.035||||||threshold p value for significance \< 0.05|t-test, 2 sided|||Left chest pain||||0.035
70972341|NCT02112370|141451176|SUPERIORITY_OR_OTHER|||||||0.089||||||threshold p value for significance \< 0.05|t-test, 2 sided|||Back pain||||0.089
70972342|NCT02112370|141451176|SUPERIORITY_OR_OTHER|||||||0.634||||||threshold p value for significance \< 0.05|t-test, 2 sided|||Posterior neck pain||||0.634
70972343|NCT00143455|141451188|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.236||||0.0556||95.0|0.995|1.536|||Cox Proportional Hazard Model|||A non-inferiority test was combined with a superiority test based on a closed testing procedure. The null hypothesis was to be rejected if the lower bound of the 2-sided 95% confidence interval for the hazard ratio (control/test) estimated from a Cox proportional hazards model, with an indicator for the control arm, was less than 0.80.||1.536|0.995|0.0556
70919360|NCT00704184|141329336|SUPERIORITY_OR_OTHER||Adjusted difference|16.2|||||TWO_SIDED|95.0|-2.2|39.5|||||Adjusted difference subtracts the percentage of placebo responders (83.3%) and stratifies by HCV genotype (1a vs. non-1a).|||39.5|-2.2|
70919361|NCT00704184|141329336|SUPERIORITY_OR_OTHER||Adjusted difference|16.9|||||TWO_SIDED|95.0|-4.0|40.2|||||Adjusted difference subtracts the percentage of placebo responders (83.3%) and stratifies by HCV genotype (1a vs. non-1a).|||40.2|-4.0|
70919362|NCT00704184|141329336|SUPERIORITY_OR_OTHER||Adjusted difference|10.7|||||TWO_SIDED|95.0|-11.4|34.6|||||Adjusted difference subtracts the percentage of placebo responders (83.3%) and stratifies by HCV genotype (1a vs. non-1a).|||34.6|-11.4|
70919363|NCT00704184|141329337|SUPERIORITY_OR_OTHER||Difference in Least Squares (LC) Means|-2.5|||||TWO_SIDED|95.0|-3.2|-1.8|||||The difference in LS Means reflects the mean decrease from baseline in HCV RNA between vaniprevir and placebo at Week 4.|||-1.8|-3.2|
70972344|NCT00143455|141451189|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.343||||0.143||95.0|0.905|1.993|||Chi-squared|||||1.993|0.905|0.143
70919364|NCT00704184|141329337|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.7|||||TWO_SIDED|95.0|-3.4|-2.0|||||The difference in LS Means reflects the mean decrease from baseline in HCV RNA between vaniprevir and placebo at Week 4.|||-2.0|-3.4|
70919365|NCT00704184|141329337|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.7|||||TWO_SIDED|95.0|-3.4|-2.0|||||The difference in LS Means reflects the mean decrease from baseline in HCV RNA between vaniprevir and placebo at Week 4.|||-2.0|-3.4|
70919366|NCT00704184|141329337|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.7|||||TWO_SIDED|95.0|-3.3|-2.0|||||The difference in LS Means reflects the mean decrease from baseline in HCV RNA between vaniprevir and placebo at Week 4.|||-2.0|-3.3|
70919367|NCT03473340|141329377|SUPERIORITY|||||||0.17697507|||||||t-test, 2 sided|||P-Value provided is for net change only.||||0.17697507
70919368|NCT03473340|141329378|SUPERIORITY|||||||0.77367872|||||||Welch Two Sample t-test|||P-Value provided is for net change only.||||0.77367872
70919369|NCT03473340|141329379|SUPERIORITY|||||||0.68595748|||||||t-test, 2 sided|||P-Value provided is for net change only.||||0.68595748
70919370|NCT03473340|141329380|SUPERIORITY|||||||0.00127634|||||||Fisher Exact|||||||0.00127634
70919371|NCT03473340|141329381|SUPERIORITY|||||||0.80904544|||||||Fisher Exact|||||||0.80904544
70919372|NCT03394885|141329382|OTHER||Exact Binomial Confidence Interval|83.0|||||TWO_SIDED|95.0|66.0|100.0||||||||100|66|
70919373|NCT01212991|141329395|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.706|||<|0.0001|TWO_SIDED|95.0|0.596|0.837||A 2-stage group sequential method (Lan DeMets OBF) assigned the level of significance for the pre-specified interim overall survival analysis (p\<0.015) based on overall 2-sided type I error rate of 0.049. Final results based upon interim analysis.|Log Rank||The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with \<1 favoring enzalutamide.|||0.837|0.596|<0.0001
70919374|NCT01212991|141329396|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.186|||<|0.0001|TWO_SIDED|95.0|0.149|0.231||The assigned 2-sided type I error rate was 0.001 for the analysis of radiographic progression-free survival.|Log Rank||The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with \< 1 favoring enzalutamide.|||0.231|0.149|<0.0001
70919375|NCT01212991|141329397|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.718|||<|0.0001||95.0|0.61|0.844||The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.01 for this analysis.|Log Rank||The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with \< 1 favoring enzalutamide.|||0.844|0.610|<0.0001
70919376|NCT01212991|141329398|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.349|||<|0.0001||95.0|0.303|0.403||The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.0125 for this analysis.|Log Rank||The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with \< 1 favoring enzalutamide.|||0.403|0.303|<0.0001
70919377|NCT01212991|141329399|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.169|||<|0.0001||95.0|0.147|0.195||The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.0167 for this analysis.|Log Rank||The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with \< 1 favoring enzalutamide.|||0.195|0.147|<0.0001
70919378|NCT01212991|141329400|SUPERIORITY_OR_OTHER_LEGACY||Difference in response rates|74.51|||<|0.0001||95.0|71.45|77.57||The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.025 for this analysis.|Cochran-Mantel-Haenszel|||||77.57|71.45|<0.0001
70919379|NCT01212991|141329401|SUPERIORITY_OR_OTHER_LEGACY||Difference in objective response rate|53.85|||<|0.0001||95.0|48.53|59.17||The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.05 for this analysis.|Cochran-Mantel-Haenszel|||||59.17|48.53|<0.0001
70919380|NCT03949335|141329405|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
70919381|NCT03949335|141329406|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
70919382|NCT03949335|141329407|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
70919383|NCT03949335|141329408|NON_INFERIORITY|Noninferiority margin equals -0.1|Mean Difference (Final Values)|-0.031|||||TWO_SIDED|95.0|-0.053|-0.01||Success criteria was evaluated using lower confidence interval. No P-Value was calculated.||||||-0.010|-0.053|
70919384|NCT03949335|141329410|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
70919385|NCT01351272|141329411|SUPERIORITY||||||=|0.09|||||||SPM two-sample t-test|||||||=0.09
70919386|NCT01351272|141329412|SUPERIORITY||||||=|0.16|||||||t-test, 1 sided|||||||= 0.16
70919387|NCT01351272|141329413|SUPERIORITY||||||=|0.09|||||||t-test, 1 sided|||||||= 0.09
70919388|NCT00801983|141329416|SUPERIORITY_OR_OTHER||||||>|0.05|||||||GEE|||Subjects were compared across keyboard types - The percentage of subjects with MSD when using the alternative keyboard were compared to the % of subjects with MSD when they were using the typical keyboard||||>.05
70919389|NCT03149991|141329426|SUPERIORITY|The unstructured covariance matrix structure was used to model nesting of observations within persons. Non-significant site interaction effects were removed one at a time. Least squares means estimates of the linear fixed effects model on SDQ change scores, adjusting for baseline covariates was used to test the primary hypothesis via contrast statements.|Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.15||0.46|TWO_SIDED||||||Mixed Models Analysis|Because sample sizes per site varied substantially, we used the Kenward-Roger degrees of freedom method.|degrees of freedom = 44.5; t=-0.74|SDQ total was primary outcome \& Day 14 primary endpoint. Change from baseline was calculated for each person at each follow-up. Change score was the dependent variable in a linear fixed effects model, where a (-)number = less severe depression. For group comparison, treatment was coded as 1 \& placebo as 0, thus a (-)value means treatment doing better. Fixed effects: group(brex v placebo), day(1-28), site(6 sites). All 2-\& 3-way interactions were included, as well as a priori defined covariates.||||0.46
70919390|NCT03149991|141329426|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.11||0.04|TWO_SIDED||||||Mixed Models Analysis||Degrees of freedom = 41.3; t=2.07.|Secondary Aim: To evaluate the short-term effect of brexpiprazole, as measured by the Symptoms of Depression Questionnaire (SDQ), on Day 2. We used the same model as in Aim 1 to test this hypothesis.||||0.04
70919391|NCT03149991|141329426|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.21||0.92|TWO_SIDED||||||Mixed Models Analysis||Degrees of freedom=38.2; t=0.10.|To evaluate the long-term effect of brexpiprazole as measured by the Symptoms of Depression Questionnaire (SDQ) on Day 28. The same model as was used in Aim 1 was used to test this hypothesis.||||0.92
70919392|NCT03149991|141329427|SUPERIORITY||Chi-squared test|0.51||||0.47|TWO_SIDED|||||This p-value was not adjusted, however there were adjustments when using a logistic regression in Statistical Analysis #2.|Chi-squared|||We used a Chi-squared test to assess differences between treatment and control in terms of percent of participants achieving a long-term sustained response, as measured by achieving a 50% or greater reduction on the MADRS on Day 28.||||0.47
70919393|NCT03149991|141329427|SUPERIORITY||Odds Ratio (OR)|1.83||||0.35|TWO_SIDED|95.0|0.52|6.44|||Regression, Logistic|Adjusted for a priori defined covariates also included in Aim 1.||Logistic regression was used to assess a difference in 50% reduction on the MADRS on Day 28 between groups.||6.44|0.52|0.35
70919394|NCT03149991|141329428|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|3.39|STANDARD_ERROR_OF_MEAN|1.59||0.04|TWO_SIDED|||||Because tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||degrees of freedom = 41.0, t=2.13.|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the MADRS change scores, reporting here information for Day 2.||||0.04
70919395|NCT03149991|141329428|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|2.94||0.73|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df = 44.2, t=-0.35|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the MADRS change scores, reporting here information for Day 14.||||0.73
70919396|NCT03149991|141329428|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|-2.86|STANDARD_ERROR_OF_MEAN|3.16||0.37|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df =44.8, t=-0.91|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the MADRS change scores, reporting here information for Day 28.||||0.37
70919397|NCT03149991|141329428|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|1.66|STANDARD_ERROR_OF_MEAN|0.85||0.06|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||degrees of freedom = 40.3, t=1.94.|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the HAMD6 change scores, reporting here information for Day 2.||||0.06
70919398|NCT03149991|141329428|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|1.06||0.83|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df = 44.2, t=-0.22|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the HAMD6 change scores, reporting here information for Day 14.||||0.83
70919399|NCT03149991|141329428|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|1.2||0.52|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df =44.0, t=-0.64|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the HAMD6 change scores, reporting here information for Day 28.||||0.52
70972345|NCT00143455|141451190|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority test was combined with a superiority test based on a closed testing procedure. The null hypothesis was to be rejected if the lower bound of the 2-sided 95% confidence interval for the hazard ratio (control/test) estimated from a Cox proportional hazards model, with an indicator for the control arm, was less than 0.80.|Hazard Ratio (HR)|1.35||||0.011||95.0|1.071|1.701|||Cox Proportional Hazard Model|||||1.701|1.071|0.0110
70972346|NCT00143455|141451191|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.354||||0.0831||95.0|0.961|1.908|||Cox Proportional Hazard Model|||||1.908|0.961|0.0831
71094037|NCT04950686|141695736|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.08||0.031|TWO_SIDED||||||Mixed Models Analysis|||||||0.031
70972347|NCT00143455|141451192|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.965||||0.7544||95.0|0.771|1.208|||Cox Proportional Hazard Model|||||1.208|0.771|0.7544
70972348|NCT03099707|141451237|SUPERIORITY||Risk Ratio (RR)|5.2||||0.105|TWO_SIDED|95.0|0.6|43.0|||Fisher Exact|||||43|0.6|0.105
70972349|NCT00487539|141451282|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
70972350|NCT00487539|141451282|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
70972351|NCT00487539|141451283|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
70972352|NCT00487539|141451283|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
70972353|NCT00487539|141451284|SUPERIORITY_OR_OTHER|||||||0.0014|||||||Chi-squared|||||||0.0014
70972354|NCT00487539|141451284|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Chi-squared|||||||0.0001
70972355|NCT00487539|141451285|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|on the van der Waerden normal scores||||||<0.0001
70972356|NCT00487539|141451285|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|on the van der Waerden normal scores||||||<0.0001
70972357|NCT00879697|141451286|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||The effect of training in both groups were assessed by a 2-way ANOVA (Time x Group) for repeated measures. When significance was obtained, the Newman-Keuls post hoc test was used to identify the differences.||||<0.05
70972358|NCT01437397|141451306|SUPERIORITY_OR_OTHER||Least squares mean difference|0.108|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.073|0.144|||Mixed Models Analysis|Treatment, sex, smoking-status, visit and group-by-visit as factors; screening pre- and post-bronchodilator FEV1, age and baseline FEV1 as covariates||||0.144|0.073|<0.0001
70972359|NCT01437397|141451306|SUPERIORITY_OR_OTHER||Least squares mean difference|0.087|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.052|0.123|||Mixed Models Analysis|Treatment, sex, smoking-status, visit and group-by-visit as factors; screening pre- and post-bronchodilator FEV1, age and baseline FEV1 as covariates||||0.123|0.052|<0.0001
70972360|NCT01437397|141451307|SUPERIORITY_OR_OTHER||Least squares mean difference|0.045|STANDARD_ERROR_OF_MEAN|0.017||0.01|TWO_SIDED|95.0|0.011|0.079|||Mixed Models Analysis|Treatment, sex, smoking-status, visit and group-by-visit as factors; screening pre- and post-bronchodilator FEV1, age and baseline FEV1 as covariates||||0.079|0.011|0.010
70972361|NCT01437397|141451307|SUPERIORITY_OR_OTHER||Least squares mean difference|0.026|STANDARD_ERROR_OF_MEAN|0.017||0.133|TWO_SIDED|95.0|-0.008|0.06|||Mixed Models Analysis|Treatment, sex, smoking-status, visit and group-by-visit as factors; screening pre- and post-bronchodilator FEV1, age and baseline FEV1 as covariates||||0.060|-0.008|0.133
71094038|NCT04950686|141695736|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.09||0.794|TWO_SIDED||||||Mixed Models Analysis|||||||0.794
70972362|NCT01437397|141451308|SUPERIORITY_OR_OTHER||Least squares mean difference|1.436|STANDARD_ERROR_OF_MEAN|0.297|<|0.0001|TWO_SIDED|95.0|0.854|2.018|||Mixed Models Analysis|Treatment group, sex, smoking-status, visit, and treatment group-by-visit as factors; visit, age baseline BDI/SGRQ as covariates||||2.018|0.854|<0.0001
70972363|NCT01437397|141451308|SUPERIORITY_OR_OTHER||Least squares mean difference|1.395|STANDARD_ERROR_OF_MEAN|0.294|<|0.0001|TWO_SIDED|95.0|0.818|1.972|||Mixed Models Analysis|Treatment group, sex, smoking-status, visit, and treatment group-by-visit as factors; visit, age baseline BDI/SGRQ as covariates||||1.972|0.818|<0.0001
70972364|NCT01437397|141451309|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.353|STANDARD_ERROR_OF_MEAN|1.075|<|0.0001|TWO_SIDED|95.0|-6.462|-2.244|||Mixed Models Analysis|Treatment group, sex, smoking-status, visit, and treatment group-by-visit as factors; visit, age baseline BDI/SGRQ as covariates||||-2.244|-6.462|<0.0001
70972365|NCT01437397|141451309|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.728|STANDARD_ERROR_OF_MEAN|1.066||0.0005|TWO_SIDED|95.0|-5.819|-1.637|||Mixed Models Analysis|Treatment group, sex, smoking-status, visit, and treatment group-by-visit as factors; visit, age baseline BDI/SGRQ as covariates||||-1.637|-5.819|0.0005
70972366|NCT00371865|141451310|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Mixed Models Analysis|||||||.27
70972367|NCT00371865|141451311|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Mixed Models Analysis|||||||.90
71094039|NCT04950686|141695737|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.07||0.277|TWO_SIDED||||||Mixed Models Analysis|||||||0.277
70972368|NCT00371865|141451312|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||.13
70972369|NCT00371865|141451313|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Mixed Models Analysis|||||||.26
70972370|NCT00371865|141451314|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Mixed Models Analysis|||||||.90
70972371|NCT04817111|141451316|OTHER|Wilcoxon signed-rank test was used to test if the change from pre- vs. post-test outcome is different from zero.||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
70972372|NCT04817111|141451318|OTHER|Wilcoxon signed-rank test was used to test if the change from pre- vs. post-test outcome is different from zero.||||||0.21|||||||Wilcoxon (Mann-Whitney)|||||||0.21
70972373|NCT04817111|141451319|OTHER|Wilcoxon signed-rank test was used to test if the change from pre- vs. post-test outcome is different from zero.||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
70972374|NCT01328951|141451321|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.8183|TWO_SIDED|95.0|0.85|1.22|||Log Rank||The HR and 95% confidence interval (CI) were estimated by Cox regression.|Unstratified Analysis.||1.22|0.85|0.8183
70972375|NCT01328951|141451321|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.5256|TWO_SIDED|95.0|0.87|1.32|||Log Rank||The HR and 95% CI were estimated by Cox regression.|Stratified Analysis: Stratified according to tumor histology, stage of disease, objective response at Baseline, bevacizumab use, smoking status, and region of enrollment.||1.32|0.87|0.5256
70972376|NCT01328951|141451322|SUPERIORITY_OR_OTHER||Difference in Event-Free Rate|-0.4||||0.9207|TWO_SIDED|95.0|-8.25|7.45|||Chi-squared|||||7.45|-8.25|0.9207
70972377|NCT01328951|141451324|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.4759|TWO_SIDED|95.0|0.8|1.11|||Log Rank||The HR and 95% CI were estimated by Cox regression.|Unstratified Analysis.||1.11|0.80|0.4759
70972378|NCT01328951|141451324|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.1635|TWO_SIDED|95.0|0.72|1.06|||Log Rank||The HR and 95% CI were estimated by Cox regression.|Stratified Analysis: Stratified according to tumor histology, stage of disease, objective response at Baseline, bevacizumab use, smoking status, and region of enrollment.||1.06|0.72|0.1635
70972379|NCT01328951|141451325|SUPERIORITY_OR_OTHER||Difference in Event-Free Rate|-2.89||||0.4069|TWO_SIDED|95.0|-9.7|3.93|||Chi-squared|||||3.93|-9.70|0.4069
70972380|NCT01328951|141451326|SUPERIORITY_OR_OTHER||Difference in Response Rate|2.78||||0.1097|TWO_SIDED|95.0|-0.78|6.35|||Chi-squared||The 95% CI for difference in response rates was constructed using the Anderson-Hauck method.|||6.35|-0.78|0.1097
70972381|NCT01328951|141451326|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|0.87|3.72|||||The 95% CI for OR was constructed using the Wald method.|||3.72|0.87|
70972382|NCT01328951|141451328|SUPERIORITY_OR_OTHER||Difference in Response Rate|1.99||||0.6062|TWO_SIDED|95.0|-5.74|9.72|||Chi-squared||The 95% CI for difference in response rates was constructed using the Anderson-Hauck method.|||9.72|-5.74|0.6062
70972383|NCT01328951|141451328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09|||||TWO_SIDED|95.0|0.79|1.49|||||The 95% CI for OR was constructed using the Wald method.|||1.49|0.79|
70972384|NCT00271817|141451343|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.4|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-41.4|-35.4||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin|||-35.4|-41.4|<0.001
71094040|NCT04950686|141695737|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.09||0.115|TWO_SIDED||||||Mixed Models Analysis|||||||0.115
71094041|NCT03421808|141695742|SUPERIORITY|||||||0.6|||||||Chi-squared|||For categorical clinical remission data we performed a chi-square test on the IIT and completer sample using Graph-Pad Prism.||||0.6
70972385|NCT00271817|141451344|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-33.5|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-36.5|-30.6||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin|||-30.6|-36.5|<0.001
70972386|NCT00271817|141451345|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|22.1|STANDARD_ERROR_OF_MEAN|1.6|<|0.001||95.0|18.8|25.3||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin|||25.3|18.8|<0.001
70972387|NCT00271817|141451346|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-18.7|||<|0.001||95.0|-22.6|-14.7||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment, baseline LDL-C, baseline TG and gender|"Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin~The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic."|||-14.7|-22.6|<0.001
70972388|NCT00271817|141451347|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.5|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|18.0|25.0||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin|||25.0|18.0|<0.001
70972389|NCT00271817|141451348|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-17.6|||<|0.001||95.0|-21.8|-13.6||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment, baseline LDL-C, baseline TG and gender.|"Median difference = Ezetimibe/Simvastatin + Niacin minus Ezetimibe/Simvastatin~The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic."|||-13.6|-21.8|<0.001
70972390|NCT00271817|141451349|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|1.6|<|0.001||95.0|-10.4|-4.2||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Median difference = Ezetimibe/Simvastatin + Niacin minus Ezetimibe/Simvastatin|||-4.2|-10.4|<0.001
71094042|NCT06717399|141695756|OTHER|The number of participants (n=15) was calculated using an effect size of 0.89. This effect size was based on a randomized clinical trial utilizing a structured mindfulness meditation program on moderate sleep disturbances in older adults (Black et al. 2015). A power of 0.8 and a significance level of 0.05 was utilized to calculate the sample size, a minimum of 12 participants is required to demonstrate significance in this study. To account for 20% attrition total participants needed is 15.||||||0.00058|||||||t-test, 2 sided|||"Null Hypothesis:~● There will not be a change in sleep quality after participation in eight mindfulness meditation sessions as measured by the Pittsburgh Sleep Quality Index."||||0.00058
71094043|NCT06717399|141695757|OTHER|||||||0.004|||||||t-test, 2 sided|||||||0.004
70919400|NCT03149991|141329428|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.19||0.11|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df = 31.0, t=1.67|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the CGI-S change scores, reporting here information for Day 2.||||0.11
70919401|NCT03149991|141329428|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.36||0.98|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df=41.1, t=-0.03|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the CGI-S change scores, reporting here information for Day 14.||||0.98
70919402|NCT03149991|141329428|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.41||0.45|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df=46.0, t=-0.76|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the CGI-S change scores, reporting here information for Day 28.||||0.45
70919403|NCT03149991|141329428|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest. This model contains an interaction effect with site, because the SITE\*DRUG effect was significant (p=0.03).|Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.29||0.02|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df=49.2, t=2.39;|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the CGI-I change scores, reporting here information for Day 2.||||0.02
70919404|NCT03149991|141329428|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest. This model contains an interaction effect with site, because the SITE\*DRUG effect was significant (p=0.03).|Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.34||0.07|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df=56.8, t=1.85|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the CGI-I change scores, reporting here information for Day 14.||||0.07
70919405|NCT03149991|141329428|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest. This model contains an interaction effect with site, because the SITE\*DRUG effect was significant (p=0.03).|Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.41||0.37|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df=50.5, t=0.91|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the CGI-I change scores, reporting here information for Day 28.||||0.37
70919406|NCT03149991|141329432|EQUIVALENCE|The hypothesis was that there would be no group differences in terms of occurrence of abnormal ECGs.|Chi-squared test|0.28||||0.6|TWO_SIDED||||||Chi-squared|||This analysis was to assess group differences (drug vs. placebo) in terms of number of abnormal ECGs out of total ECGs assessed.||||0.60
70919407|NCT03149991|141329432|EQUIVALENCE|The hypothesis was that there would be no group differences in number/percentage of people with an abnormal ECG at baseline.|Chi-squared test|0.94||||0.33|TWO_SIDED||||||Chi-squared|||This analysis was to assess for group differences (drug vs. placebo) in number/percentage of people with an abnormal ECG at baseline.||||0.33
70919408|NCT03149991|141329432|EQUIVALENCE|The hypothesis was that there would be no group differences in number/percentage of people with an abnormal ECG at Visit 4.|Chi-squared test|0.0||||1|TWO_SIDED||||||Chi-squared|||This analysis was to assess for group differences (drug vs. placebo) in number/percentage of people with an abnormal ECG at Visit 4.||||1.00
70919409|NCT03149991|141329432|EQUIVALENCE|The hypothesis was that there would be no group differences in number/percentage of people with an abnormal ECG at Visit 5.|Chi-squared test|0.08||||0.78|TWO_SIDED||||||Chi-squared|||This analysis was to assess for group differences (drug vs. placebo) in number/percentage of people with an abnormal ECG at Visit 5.||||0.78
70919410|NCT03149991|141329432|EQUIVALENCE|The hypothesis was that there would be no group differences in number/percentage of people with an abnormal ECG at Visit 6.|Chi-squared test|0.02||||0.9|TWO_SIDED||||||Chi-squared|||This analysis was to assess for group differences (drug vs. placebo) in number/percentage of people with an abnormal ECG at Visit 6.||||0.90
70972391|NCT00271817|141451350|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|1.6||0.004||95.0|-8.0|-1.5||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Ezetimibe/Simvastatin|||-1.5|-8.0|0.004
70972392|NCT00271817|141451351|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-7.7|-2.1||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin|||-2.1|-7.7|<0.001
70972393|NCT00271817|141451352|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.7|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-10.4|-5.0||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Ezetimibe/Simvastatin|||-5.0|-10.4|<0.001
70972394|NCT01295216|141451439|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.37|||||TWO_SIDED|95.0|-2.15|1.4|||||Systolic blood pressure at 12 months|||1.40|-2.15|
70972395|NCT01295216|141451439|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|||||TWO_SIDED|95.0|-1.29|1.32|||||Diastolic blood pressure for 12 months|||1.32|-1.29|
70972396|NCT03124563|141451445|SUPERIORITY||||||=|0.006|||||||Mixed Models Analysis|Controlling for age, gender, and functional health||||||=.006
70972397|NCT03124563|141451446|SUPERIORITY|||||||0.034|||||||Mixed Models Analysis|Controlling for age, gender, and functional health||||||.034
70972398|NCT03124563|141451447|SUPERIORITY|||||||0.065|||||||Mixed Models Analysis|Controlling for age, gender, and education||||||.065
70972399|NCT03124563|141451448|SUPERIORITY|||||||0.308|||||||Mixed Models Analysis|Controlling for age, gender, and level of education||||||.308
70972400|NCT03124563|141451449|SUPERIORITY|||||||0.349|||||||ANOVA|||||||.349
70972401|NCT03124563|141451450|SUPERIORITY|||||||0.022|||||||Mixed Models Analysis|Controlling for age, gender, and level of education||||||.022
70972402|NCT05110300|141451451|SUPERIORITY|||||||0.0283||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANOVA|2-Way ANOVA with Fisher's LSD correction for multiple comparisons.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.0283
70972403|NCT05110300|141451452|SUPERIORITY|||||||0.3118||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANOVA|2-Way ANOVA with Fisher's LSD correction for multiple comparisons.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.3118
70919411|NCT03149991|141329432|EQUIVALENCE|The hypothesis was that there would be no group differences in number/percentage of people with an abnormal ECG at Visit 7.|Chi-squared test|0.63||||0.43|TWO_SIDED||||||Chi-squared|||This analysis was to assess for group differences (drug vs. placebo) in number/percentage of people with an abnormal ECG at Visit 7.||||0.43
70919412|NCT03149991|141329432|EQUIVALENCE|The hypothesis was that there would be no group differences in number/percentage of people with an abnormal ECG at Visit 9.|Chi-squared test|0.09||||0.76|TWO_SIDED||||||Chi-squared|||This analysis was to assess for group differences (drug vs. placebo) in number/percentage of people with an abnormal ECG at Visit 9.||||0.76
70972404|NCT05110300|141451453|SUPERIORITY|||||||0.213||||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||To evaluate differences in average outcome measure score change from baseline to last study session, a 2-sided t-test was used, with non-parametric analysis used as necessary.||||0.213
70972405|NCT05110300|141451453|EQUIVALENCE|MDC of the inpatient stroke population for the BBS was used as the equivalence bounds. Equivalence bounds were set at +/- 6.9|||||<|0.001||||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||||||<0.001
70972406|NCT05110300|141451453|SUPERIORITY|||||||0.32||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANCOVA|ANCOVA, with the number of sessions completed as the covariate.||Because each participant may have had a different number of BWSS sessions completed, an ANCOVA was used to assess for mean differences in outcome score change while controlling for the number of BWSS sessions completed||||0.320
70972407|NCT05110300|141451454|SUPERIORITY|||||||0.2612||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Mixed Models Analysis|Because some values are missing, these data were analyzed by fitting a mixed model, rather than by repeated measures ANOVA.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.2612
70972408|NCT05110300|141451455|SUPERIORITY|||||||0.541||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Mixed Models Analysis|Because some values are missing, these data were analyzed by fitting a mixed model, rather than by repeated measures ANOVA.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.5410
70972409|NCT05110300|141451456|SUPERIORITY|||||||0.6282||||||The a priori threshold for statistical significance was p\<0.05.|Wilcoxon (Mann-Whitney)|||To evaluate differences in average outcome measure score change from baseline to last study session, a 2-sided t-test was used, with non-parametric analysis used as necessary.||||0.6282
70972410|NCT05110300|141451456|SUPERIORITY|||||||0.5056||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANCOVA|ANCOVA, with the number of sessions completed as the covariate.||Because each participant may have had a different number of BWSS sessions completed, an ANCOVA was used to assess for mean differences in outcome score change while controlling for the number of BWSS sessions completed||||0.5056
71008725|NCT02055976|141525247|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-29.187|STANDARD_ERROR_OF_MEAN|7.242|<|0.001|TWO_SIDED|95.0|-43.571|-14.803|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-14.803|-43.571|<0.001
71094044|NCT00177671|141695796|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.97|STANDARD_DEVIATION|2.09||0.05|TWO_SIDED|95.0|1.0|4.41|||Log Rank|||We followed the intention to treat principle. We used Kaplan-Meier curves to quantify the percentage of participants who were free of depression recurrence over time. Cox proportional hazard models quantified hazard ratios comparing the 2 treatment groups.||4.41|1.00|.05
70919413|NCT03149991|141329434|EQUIVALENCE|The hypothesis was that there would be no group differences in number of participants reporting adverse events.|Chi-squared test|0.009||||0.92|TWO_SIDED||||||Chi-squared|||This analysis assessed group differences (drug vs. placebo) in terms of number of participants reporting adverse events.||||0.92
70919414|NCT03149991|141329435|EQUIVALENCE|The hypothesis was that there would be no difference between the groups in terms of mean number of adverse events per person, among those who reported any adverse events.|Mean Difference (Final Values)|0.24||||0.81|TWO_SIDED||||||t-test, 2 sided|||This analysis assessed group differences (drug vs. placebo) in terms of mean number of adverse events per person, among those who reported any adverse events.||||0.81
70919415|NCT03149991|141329436|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared test|0.43||||0.51|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) throughout the trial.||||0.51
70919416|NCT03149991|141329436|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|2.85||||0.09|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) at Screening.||||0.09
70919417|NCT03149991|141329436|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.004||||0.95|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) at Baseline.||||0.95
70919418|NCT03149991|141329436|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.005||||0.94|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 1.||||0.94
70919419|NCT03149991|141329436|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|1.97||||0.16|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 2.||||0.16
70919420|NCT03149991|141329436|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.44||||0.51|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 5.||||0.51
70919421|NCT03149991|141329436|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.94||||0.33|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 8.||||0.33
70919422|NCT03149991|141329436|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.003||||0.96|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 11.||||0.96
70919423|NCT03149991|141329436|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.5||||0.48|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 14.||||0.48
70919424|NCT03149991|141329436|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.67||||0.41|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 17.||||0.41
70972411|NCT05110300|141451457|SUPERIORITY|||||||0.558||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Mixed Models Analysis|Because some values are missing, these data were analyzed by fitting a mixed model, rather than by repeated measures ANOVA.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.5580
71154043|NCT05230433|141800440|OTHER|No test vs. control groups.||||||0.65||||||This p-value is not adjusted for multiple comparisons.|Pearson Correlation|||Fold change from 60 to 180 minutes of average medium chain acylcarnitine was calculated for each participant. Pearson correlation between BMI percentile and fold change was calculated.|Pearson Correlation between both secondary outcomes reported: BMI percentile and fold change between acylcarnitine at 60 minutes and 180 minutes post the high fat challenge.|||0.65
70919425|NCT03149991|141329436|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.17||||0.68|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 21.||||0.68
70919426|NCT03149991|141329436|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.67||||0.41|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 23.||||0.41
70919427|NCT03149991|141329436|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.67||||0.41|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 28.||||0.41
70919428|NCT03546608|141329437|OTHER||Ratio of Geometric Least Square Mean (%)|94.99|||||TWO_SIDED|90.0|64.75|139.35||||||||139.35|64.75|
70919429|NCT03546608|141329437|OTHER||Ratio of Geometric Least Square Mean (%)|87.92|||||TWO_SIDED|90.0|59.93|128.98||||||||128.98|59.93|
70919430|NCT03546608|141329438|OTHER||Ratio of Geometric Least Square Mean (%)|94.81|||||TWO_SIDED|90.0|64.09|140.26||||||||140.26|64.09|
70919431|NCT03546608|141329438|OTHER||Ratio of Geometric Least Square Mean (%)|87.2|||||TWO_SIDED|90.0|58.94|129.0||||||||129.00|58.94|
70919432|NCT03546608|141329439|OTHER||Ratio of Geometric Least Square Mean (%)|102.45|||||TWO_SIDED|90.0|80.9|129.73||||||||129.73|80.90|
70919433|NCT03546608|141329439|OTHER||Ratio of Geometric Least Square Mean (%)|71.02|||||TWO_SIDED|90.0|56.08|89.93||||||||89.93|56.08|
71031895|NCT01015625|141572582|SUPERIORITY|A two-sided significance level of 5% was used.|Cox Proportional Hazard|1.45||||0.147|TWO_SIDED|95.0|0.87|2.42|||Log Rank||From the Cox Proportional hazard model with surgery vs no surgery fitted as a covariate. A hazard ratio \> 1.0 indicates a higher average event rate and a shorter time to distant progression for surgery relative to no surgery.|To determine the effect of local therapy (surgery) compared to systemic therapy only in synchronous metastasized breast cancer patients in terms of time from randomization to distant progression. Distant progression is defined as detection of new lesions or progression of existing metastases in locations different then breast. Participants last known to be alive without a distant progression were censored at their last contact date or at the data cut-off date whichever came first.||2.42|0.87|0.147
70919434|NCT03546608|141329450|OTHER||Ratio of Geometric Least Square Mean (%)|82.62|||||TWO_SIDED|90.0|45.67|149.47|||||For MSC2571109|||149.47|45.67|
70919435|NCT03546608|141329450|OTHER||Ratio of Geometric Least Square Mean (%)|136.59|||||TWO_SIDED|90.0|75.5|247.12|||||For MSC2571109|||247.12|75.50|
70919436|NCT03546608|141329450|OTHER||Ratio of Geometric Least Square Mean (%)|100.47|||||TWO_SIDED|90.0|54.53|185.1|||||For MSC2571107|||185.10|54.53|
70919437|NCT03546608|141329450|OTHER||Ratio of Geometric Least Square Mean (%)|94.48|||||TWO_SIDED|90.0|51.28|174.07|||||For MSC2571107|||174.07|51.28|
70919438|NCT03546608|141329451|OTHER||Ratio of Geometric Least Square Mean (%)|82.35|||||TWO_SIDED|90.0|45.56|148.84|||||For MSC2571109|||148.84|45.56|
70919439|NCT03546608|141329451|OTHER||Ratio of Geometric Least Square Mean (%)|137.51|||||TWO_SIDED|90.0|76.08|248.54|||||For MSC2571109|||248.54|76.08|
70919440|NCT03546608|141329451|OTHER||Ratio of Geometric Least Square Mean (%)|100.81|||||TWO_SIDED|90.0|55.16|184.23|||||For MSC2571107|||184.23|55.16|
70919441|NCT03546608|141329451|OTHER||Ratio of Geometric Least Square Mean (%)|96.18|||||TWO_SIDED|90.0|52.63|175.78|||||For MSC2571107|||175.78|52.63|
70919442|NCT03546608|141329452|OTHER||Ratio of Geometric Least Square Mean (%)|92.3|||||TWO_SIDED|90.0|62.52|136.26|||||For MSC2571109|||136.26|62.52|
70919443|NCT03546608|141329452|OTHER||Ratio of Geometric Least Square Mean (%)|114.8|||||TWO_SIDED|90.0|77.76|169.48|||||For MSC2571109|||169.48|77.76|
70919444|NCT03546608|141329452|OTHER||Ratio of Geometric Least Square Mean (%)|106.51|||||TWO_SIDED|90.0|70.25|161.49|||||For MSC2571107|||161.49|70.25|
70919445|NCT03546608|141329452|OTHER||Ratio of Geometric Least Square Mean (%)|72.58|||||TWO_SIDED|90.0|47.87|110.04|||||For MSC2571107|||110.04|47.87|
71154044|NCT02869867|141800481|SUPERIORITY||Mean Difference (Final Values)|3.2|||<|0.001|TWO_SIDED|95.0|2.09|4.31|||Mixed Models Analysis|||||4.31|2.09|<0.001
70919446|NCT05135000|141329501|OTHER||Cox Proportional Hazard|0.7||||0.6843|TWO_SIDED|80.0|0.2|2.8|||Log Rank|||||2.8|0.2|0.6843
70919447|NCT00130117|141329507|SUPERIORITY_OR_OTHER|||||||0.024|||||||ANOVA|||||||0.024
70919448|NCT00130117|141329507|SUPERIORITY|||||||0.049|||||||ANOVA|||||||0.049
70919449|NCT00130117|141329508|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.6||||0.02|TWO_SIDED|||||"p value reflects treatment of leptin for on-treatment, n=4"|ANOVA|||||||0.02
70919450|NCT03785782|141329548|OTHER|||||||0.2988|||||||Regression, Logistic|||||||0.2988
70919451|NCT03785782|141329549|OTHER|||||||0.36|||||||Regression, Linear|||||||0.36
70919452|NCT03785782|141329550|OTHER|||||||0.43|||||||Regression, Linear|||||||0.43
70919453|NCT03785782|141329551|OTHER|||||||0.42|||||||Regression, Linear|||||||0.42
70919454|NCT03785782|141329552|OTHER|||||||0.45|||||||Regression, Linear|||||||0.45
70919455|NCT03785782|141329553|OTHER|||||||0.18|||||||Regression, Linear|||||||0.18
70919456|NCT03785782|141329554|OTHER|||||||0.78|||||||Regression, Linear|||||||0.78
70919457|NCT03785782|141329555|OTHER|||||||0.45|||||||Regression, Linear|||||||0.45
70919458|NCT03785782|141329556|OTHER|||||||0.34|||||||Regression, Linear|||||||0.34
70919459|NCT03785782|141329557|OTHER|||||||0.7465|||||||Regression, Logistic|||||||0.7465
70919460|NCT03785782|141329558|OTHER|||||||0.0466|||||||Regression, Logistic|||||||0.0466
70919461|NCT03785782|141329559|OTHER|||||||0.1567|||||||Regression, Logistic|||||||0.1567
70919462|NCT03785782|141329560|OTHER|||||||0.1837|||||||Regression, Logistic|||||||0.1837
70919463|NCT03785782|141329561|OTHER|||||||0.7447|||||||Regression, Logistic|||||||0.7447
70919464|NCT03785782|141329562|OTHER|||||||0.0739|||||||Regression, Logistic|||||||0.0739
70919465|NCT03785782|141329563|OTHER|||||||0.9995|||||||Regression, Logistic|||||||0.9995
70919466|NCT05777785|141329565|SUPERIORITY|Power analysis determined that a sample size of 90 participants will have 80% power to detect an effect size of 0.30 (Cohen's D) using a paired t-test with a 0.05 two-sided significance level.|Mean Difference (Final Values)|0.9789||||0.037|TWO_SIDED||||||t-test, 2 sided|||||||0.037
70919467|NCT05777785|141329567|SUPERIORITY|Power analysis determined that a sample size of 90 participants will have 80% power to detect an effect size of 0.30 (Cohen's D) using a paired t-test with a 0.05 two-sided significance level.|Mean Difference (Final Values)|2.09||||0.027|TWO_SIDED||||||t-test, 2 sided|||||||0.027
70919468|NCT05777785|141329568|SUPERIORITY|Power analysis determined that a sample size of 90 participants will have 80% power to detect an effect size of 0.30 (Cohen's D) using a paired t-test with a 0.05 two-sided significance level.|Mean Difference (Final Values)|2.09||||0.029|TWO_SIDED||||||t-test, 2 sided|||||||0.029
70919469|NCT02763319|141329575|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.468|TWO_SIDED|95.0|0.837|1.351|||Inverse normal test|The Inverse Normal method combines information (p-value) from the interim analysis and information from the final analysis.|The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per the Interactive Web Response System (IWRS). Rituximab + bendamustine was the reference treatment group.|||1.351|0.837|0.468
70919470|NCT02763319|141329576|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.568|TWO_SIDED|95.0|0.586|1.33|||Inverse normal test|The Inverse Normal method combines information (p-value) from the interim analysis and information from the final analysis.|The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per the Interactive Web Response System. Rituximab + bendamustine is the reference treatment group.|||1.330|0.586|0.568
70919471|NCT02763319|141329577|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.812|1.779|||||||A Cochran-Mantel-Haenszel (CMH) test stratified by Baseline stratification factors was performed for response variable coded as follows: 1 for response (CR or PR) and 0 for nonresponse (stable disease \[SD\] or progressive disease \[PD\] or unknown).|1.779|0.812|
70972412|NCT05110300|141451458|SUPERIORITY|||||||0.0897||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Mixed Models Analysis|Because some values are missing, these data were analyzed by fitting a mixed model, rather than by repeated measures ANOVA.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.0897
70972413|NCT05110300|141451459|SUPERIORITY|||||||0.0549||||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||To evaluate differences in average outcome measure score change from baseline to last study session, a 2-sided t-test was used, with non-parametric analysis used as necessary.||||0.0549
71094045|NCT02293499|141695798|SUPERIORITY||partial eta squared|0.003||||0.043|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.043
71094046|NCT02293499|141695798|SUPERIORITY||partial eta squared|0.21||||0|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.00
71094047|NCT02293499|141695798|SUPERIORITY||Sobel Statistic|2.4119||||0.0079|TWO_SIDED||||||Sobel|||Mediator analysis of AMI-SEI subscale on quality of life||||.0079
71094048|NCT02293499|141695798|SUPERIORITY||Sobel Statistic|2.1132||||0.0172|TWO_SIDED||||||Sobel|||Mediator analysis of ACQ Total score subscale on quality of life||||.0172
71094049|NCT02293499|141695799|SUPERIORITY||partial eta squared|0.001||||0.295|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||0.295
71094050|NCT02293499|141695799|SUPERIORITY||partial eta squared|0.15||||0|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.00
71094051|NCT02293499|141695800|SUPERIORITY||partial eta squared|0.002||||0.14|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.140
71094052|NCT02293499|141695800|SUPERIORITY||partial eta squared|0.15||||0|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.00
70972414|NCT05110300|141451459|SUPERIORITY|||||||0.05626||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANCOVA|ANCOVA, with the number of sessions completed as the covariate.||Because each participant may have had a different number of BWSS sessions completed, an ANCOVA was used to assess for mean differences in outcome score change while controlling for the number of BWSS sessions completed||||0.05626
70972415|NCT05110300|141451460|SUPERIORITY|||||||0.0706||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANOVA|2-Way ANOVA with Fisher's LSD correction for multiple comparisons.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.0706
71094053|NCT02293499|141695801|SUPERIORITY||partial eta squared|0.001||||0.268|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.268
71094054|NCT02293499|141695801|SUPERIORITY||partial eta squared|0.06||||0.14|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.14
71094055|NCT02293499|141695802|SUPERIORITY||partial eta squared|0.001||||0.238|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.238
71094056|NCT02293499|141695802|SUPERIORITY||partial eta squared|0.03||||0.43|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.43
71094057|NCT02293499|141695802|SUPERIORITY||Slope|-0.203||||0.024|TWO_SIDED||||||Mixed Models Analysis|||||||.024
71094058|NCT02293499|141695803|SUPERIORITY||partial eta squared|0.0||||0.484|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.484
71094059|NCT02293499|141695803|SUPERIORITY||partial eta squared|0.12||||0|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.00
71094060|NCT02293499|141695804|SUPERIORITY||partial eta squared|0.0||||0.648|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.648
71094061|NCT02293499|141695804|SUPERIORITY||partial eta squared|0.07||||0.04|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.04
71154045|NCT04250194|141800509|NON_INFERIORITY|The noninferiority margin was 10%.|absolute difference in percentage points|5.4||||0.003|TWO_SIDED|95.0|-6.5|17.2||The threshold for statistical significance was p = 0.05. The p value was not adjusted for multiple comparisons.|One-sided two-sample z-test||Difference in diagnostic accuracy = navigational bronchoscopy % - transthoracic biopsy %|||17.2|-6.5|0.003
71154046|NCT04516967|141800527|SUPERIORITY|||||||0.0077|||||||Fisher Exact|||||||0.0077
70919472|NCT02763319|141329578|SUPERIORITY||Odds Ratio (OR)|1.54|||||TWO_SIDED|95.0|0.778|3.041|||||||A Cochran-Mantel-Haenszel (CMH) test stratified by Baseline stratification factors was performed for response variable coded as follows: 1 for response (CR or PR) and 0 for nonresponse (stable disease \[SD\] or progressive disease \[PD\] or unknown).|3.041|0.778|
70919473|NCT02763319|141329579|SUPERIORITY||Hazard Ratio (HR)|1.28|||||TWO_SIDED|95.0|0.938|1.745|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.745|0.938|
70919474|NCT02763319|141329580|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.673|2.035|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|2.035|0.673|
70919475|NCT02763319|141329581|SUPERIORITY||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.875|1.452|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.452|0.875|
70919476|NCT02763319|141329582|SUPERIORITY||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.682|1.626|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.626|0.682|
70919477|NCT02763319|141329583|SUPERIORITY||Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.829|1.985|||||||A CMH test stratified by Baseline stratification factors was performed for response variable coded as follows: 1 for response (CR or PR) and 0 for nonresponse (stable disease \[SD\] or progressive disease \[PD\] or unknown).|1.985|0.829|
70919478|NCT02763319|141329584|SUPERIORITY||Odds Ratio (OR)|1.62|||||TWO_SIDED|95.0|0.755|3.457|||||||A CMH test stratified by Baseline stratification factors was performed for response variable coded as follows: 1 for response (CR or PR) and 0 for nonresponse (stable disease \[SD\] or progressive disease \[PD\] or unknown).|3.457|0.755|
70919479|NCT02763319|141329585|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.831|1.416|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.416|0.831|
70919480|NCT02763319|141329586|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.633|1.595|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.595|0.633|
70919481|NCT02763319|141329587|SUPERIORITY||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.794|1.244|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.244|0.794|
70919482|NCT02763319|141329588|SUPERIORITY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.57|1.22|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.220|0.570|
70919483|NCT01622868|141329609|SUPERIORITY|||||||0.97||||||One-sided significance level = 0.10|Z-test|||The study was designed to see if there is a signal in the 12-week CR rate with the addition of lapatinib to warrant a future phase III trial. Null hypothesis: the 12-week post-WBRT/SRS CR rate is ≤ 5%; alternative hypothesis: the addition of lapatinib will increase that CR rate to at least 20%. 114 eligible participants provide 86% power to detect a 15% absolute increase in CR rate at a significance level of 0.10, using a 1-sided Z-test for the difference of 2 proportions.||||0.97
70919484|NCT01622868|141329610|SUPERIORITY|||||||0.78||||||One-sided significance level = 0.10|Z-test|||||||0.78
71094062|NCT02293499|141695805|SUPERIORITY||partial eta squared|0.003||||0.02|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.020
71094063|NCT02293499|141695805|SUPERIORITY||partial eta squared|0.04||||0.23|TWO_SIDED|||||A priori threshold for statistical significance is \<.05|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.23
71094064|NCT02293499|141695806|SUPERIORITY||partial eta squared|0.002||||0.049|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.049
71094065|NCT02293499|141695806|SUPERIORITY||partial eta squared|0.12||||0|TWO_SIDED|||||A priori threshold for statistical significance is \<.05|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.00
71094066|NCT02293499|141695806|SUPERIORITY||Slope|-0.294||||0.004|TWO_SIDED||||||Mixed Models Analysis|||||||.004
71094067|NCT02293499|141695806|SUPERIORITY||Sobel Statistic|-2.3505||||0.0093|TWO_SIDED||||||Sobel|||Mediator analysis of AMI-SEI subscale on ACQ total||||.0093
71094068|NCT05370326|141695820|SUPERIORITY||Mean Difference (Net)|0.89||||0.69|TWO_SIDED|95.0|-3.67|5.46|||t-test, 2 sided|||||5.46|-3.67|0.69
71094069|NCT05370326|141695825|SUPERIORITY||Mean Difference (Net)|0.23||||0.67|TWO_SIDED|95.0|-0.89|1.36|||t-test, 2 sided|||||1.36|-0.89|0.67
71094070|NCT05370326|141695826|SUPERIORITY||Mean Difference (Net)|0.59||||0.5|TWO_SIDED|95.0|-1.16|2.34|||t-test, 2 sided|||||2.34|-1.16|0.50
71094071|NCT05370326|141695827|SUPERIORITY||Mean Difference (Net)|0.2||||0.74|TWO_SIDED|95.0|-1.09|1.51|||t-test, 2 sided|||||1.51|-1.09|0.74
71094072|NCT05370326|141695829|SUPERIORITY|||||||0.33|||||||Chi-squared|||||||0.33
70919485|NCT01622868|141329611|SUPERIORITY|||||||0.78||||||One-sided significance level = 0.10|Z-test|||4 weeks post-RT||||0.78
70919486|NCT01622868|141329611|SUPERIORITY|||||||0.97||||||One-sided significance level = 0.10|Z-test|||12 weeks post-RT||||0.97
71094073|NCT05370326|141695830|SUPERIORITY|||||||0.47|||||||Chi-squared|||||||0.47
71094074|NCT00817063|141695885|SUPERIORITY||Odds Ratio (OR)|3.78|||<|0.001|TWO_SIDED|95.0|2.55|5.62|||Chi-squared, Corrected|||||5.62|2.55|<0.001
71094075|NCT00817063|141695885|SUPERIORITY||Difference in Percentage|24.8|||<|0.001|TWO_SIDED|95.0|18.0|31.7|||Chi-squared, Corrected|||||31.7|18.0|<0.001
71094076|NCT00817063|141695886|SUPERIORITY||Mean Difference (Net)|-24.13|||<|0.001|TWO_SIDED|95.0|-30.4|-17.85|||Kruskal-Wallis|||||-17.85|-30.40|<0.001
71094077|NCT00817063|141695887|SUPERIORITY||Odds Ratio (OR)|4.05|||<|0.001|TWO_SIDED|95.0|2.71|6.07|||Chi-squared, Corrected|||||6.07|2.71|<0.001
70919487|NCT01622868|141329617|SUPERIORITY|||||||1||||||One-sided significance level = 0.10|z-test|||||||1.00
70919488|NCT01622868|141329619|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.67|TWO_SIDED|95.0|0.62|1.36||Two-sided significance level = 0.05|Log Rank|||||1.36|0.62|0.67
71094078|NCT00817063|141695887|SUPERIORITY||Difference in Percentage|25.5|||<|0.001|TWO_SIDED|95.0|18.7|32.3|||Chi-squared, Corrected|||||32.3|18.7|<0.001
71094079|NCT00817063|141695888|SUPERIORITY||Mean Difference (Net)|-22.36|||<|0.001|TWO_SIDED|95.0|-31.0|-13.73|||Kruskal-Wallis|||||-13.73|-31.00|<0.001
71094080|NCT00817063|141695889|SUPERIORITY|||||||0.047|||||||Log Rank|||||||0.047
71094081|NCT00817063|141695890|SUPERIORITY|||||||0.068|||||||Log Rank|||||||0.068
71094082|NCT00817063|141695891|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
71094083|NCT00817063|141695900|SUPERIORITY||Mean Difference (Net)|0.489||||0.179|TWO_SIDED|95.0|-0.226|1.204||The analysis of covariance model includes treatment, age at Baseline, gender, menopausal status of females, baseline BMD score and duration of treatment exposure (\<12weeks, \>=12 weeks) as covariates.|ANCOVA|||Lumbar Spine BMD||1.204|-0.226|0.179
71094084|NCT00817063|141695900|SUPERIORITY||Mean Difference (Net)|0.497||||0.089|TWO_SIDED|95.0|-0.077|1.071||The analysis of covariance model includes treatment, age at Baseline, gender, menopausal status of females, baseline BMD score and duration of treatment exposure (\<12weeks, \>=12 weeks) as covariates.|ANCOVA|||Femur BMD||1.071|-0.077|0.089
71094085|NCT02111980|141695912|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||t-test, 2 sided|||||||1.0
71094086|NCT01922011|141695929|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower bound of the 2-sided 95% CI is greater than -15%|Common Difference|-6.1||||0.421|TWO_SIDED|95.0|-19.4|7.4|||Wald||Daptomycin - Comparator|95% confidence interval of the common difference was based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.||7.4|-19.4|0.421
71094087|NCT01922011|141695930|SUPERIORITY_OR_OTHER||Common difference|-7.1||||0.467|TWO_SIDED|95.0|-21.6|7.9|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|||7.9|-21.6|0.467
71094088|NCT01922011|141695931|SUPERIORITY_OR_OTHER||Common difference|-6.2||||0.313|TWO_SIDED|95.0|-17.5|5.0|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|At EOIV visit||5.0|-17.5|0.313
71154047|NCT04516967|141800528|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71154048|NCT04516967|141800529|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71154049|NCT04516967|141800530|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
70919489|NCT00232180|141329647|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.535|0.741||Using an adaptation of Haybittle-Peto stopping criterion adjusting for two interim analyses, p-value for final primary analysis will be compared to alpha=0.049. No adjustment in alpha will be made on parameters/endpoints other than primary endpoint.|Cox proportional hazard model|||Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, time from electrocardiogram Q wave to the end of the S wave corresponding to ventricle depolarization (QRS) and atrial fibrillation as covariates.||0.741|0.535|<0.0001
70919490|NCT00232180|141329649|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.647|||<|0.0001|TWO_SIDED|95.0|0.552|0.757||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.757|0.552|<0.0001
70919491|NCT00232180|141329650|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.761||||0.0081|TWO_SIDED|95.0|0.622|0.932||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.932|0.622|0.0081
70919492|NCT00232180|141329651|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.757||||0.012|TWO_SIDED|95.0|0.609|0.941||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.941|0.609|0.0120
70919493|NCT00232180|141329652|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.768|||<|0.0001|TWO_SIDED|95.0|0.673|0.876||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.876|0.673|<0.0001
70919494|NCT00232180|141329653|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.576|||<|0.0001|TWO_SIDED|95.0|0.473|0.702||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.702|0.473|<0.0001
70919495|NCT00232180|141329654|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.751|||<|0.0001|TWO_SIDED|95.0|0.664|0.849||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.849|0.664|<0.0001
70919496|NCT00232180|141329655|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.577|||<|0.0001|TWO_SIDED|95.0|0.475|0.701||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.701|0.475|<0.0001
70919497|NCT00232180|141329656|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.694|||<|0.0001|TWO_SIDED|95.0|0.598|0.806||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.806|0.598|<0.0001
70919498|NCT00232180|141329657|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.316||||0.2321|TWO_SIDED|95.0|0.839|2.064||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||2.064|0.839|0.2321
70972416|NCT05110300|141451461|SUPERIORITY|||||||0.1629||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANOVA|2-Way ANOVA with Fisher's LSD correction for multiple comparisons.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.1629
71154050|NCT04516967|141800531|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71094089|NCT01922011|141695931|SUPERIORITY_OR_OTHER||Common difference|-7.9||||0.239|TWO_SIDED|95.0|-19.8|4.0|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|At EOT visit||4.0|-19.8|0.239
70972417|NCT05110300|141451462|SUPERIORITY|||||||0.4271||||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||To evaluate differences in average outcome measure score change from baseline to last study session, a 2-sided t-test was used, with non-parametric analysis used as necessary.||||0.4271
70972418|NCT05110300|141451462|SUPERIORITY|||||||0.419||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANCOVA|ANCOVA, with the number of sessions completed as the covariate.||Because each participant may have had a different number of BWSS sessions completed, an ANCOVA was used to assess for mean differences in outcome score change while controlling for the number of BWSS sessions completed||||0.4190
70972419|NCT05110300|141451463|SUPERIORITY|||||||0.3444||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANOVA|2-Way ANOVA with Fisher's LSD correction for multiple comparisons.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.3444
70972420|NCT05110300|141451464|SUPERIORITY|||||||0.3581||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANOVA|2-Way ANOVA with Fisher's LSD correction for multiple comparisons.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.3581
70972421|NCT05110300|141451465|SUPERIORITY|||||||0.906||||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||To evaluate differences in average outcome measure score change from baseline to last study session, a 2-sided t-test was used, with non-parametric analysis used as necessary.||||0.9060
70972422|NCT05110300|141451465|SUPERIORITY|||||||0.0848||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANCOVA|ANCOVA, with the number of sessions completed as the covariate.||Because each participant may have had a different number of BWSS sessions completed, an ANCOVA was used to assess for mean differences in outcome score change while controlling for the number of BWSS sessions completed||||0.0848
70972423|NCT01885000|141451506|SUPERIORITY||||||=|0.0065|||||||Cochran-Mantel-Haenszel|||||||= 0.0065
70972424|NCT01885000|141451507|SUPERIORITY||||||=|0.0328|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who satisfied with appearance.||||= 0.0328
70972425|NCT01885000|141451507|SUPERIORITY||||||=|0.5312|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who appearance acceptable.||||= 0.5312
70972426|NCT01885000|141451507|SUPERIORITY||||||=|0.0756|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who appearance concerned.||||= 0.0756
70972427|NCT01885000|141451507|SUPERIORITY||||||=|0.0083|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who embarrassed with facial redness.||||= 0.0083
70972428|NCT01885000|141451507|SUPERIORITY||||||=|0.0076|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who self-conscious.||||= 0.0076
70972429|NCT01885000|141451507|SUPERIORITY||||||=|0.2186|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who's frequency control last 24 hours||||= 0.2186
70972430|NCT01885000|141451507|SUPERIORITY||||||=|0.2373|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who are frustrated.||||= 0.2373
70972431|NCT01885000|141451507|SUPERIORITY||||||=|0.7769|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who cover up or camouflage.||||= 0.7769
70972432|NCT01885000|141451507|SUPERIORITY||||||=|0.8764|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who pay attention to the known triggers.||||= 0.8764
70972433|NCT01885000|141451507|SUPERIORITY||||||=|0.6149|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who avoid the known triggers.||||= 0.6149
71094090|NCT01922011|141695931|SUPERIORITY_OR_OTHER||Common difference|-6.7||||0.37|TWO_SIDED|95.0|-19.1|5.8|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|At TOC visit||5.8|-19.1|0.370
70972434|NCT01885000|141451507|SUPERIORITY||||||=|0.8361|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who interfering with social life.||||= 0.8361
70972435|NCT01885000|141451507|SUPERIORITY||||||=|0.6259|||||||Cochran-Mantel-Haenszel|||Interfering with work life||||= 0.6259
70972436|NCT01885000|141451508|SUPERIORITY||||||=|0.5821|||||||Cochran-Mantel-Haenszel|||This analysis was performed for Mobility.||||= 0.5821
70972437|NCT01885000|141451508|SUPERIORITY||||||=|0.8864|||||||Cochran-Mantel-Haenszel|||This analysis was performed for Self-Care.||||= 0.8864
70972438|NCT01885000|141451508|SUPERIORITY||||||=|0.9579|||||||Cochran-Mantel-Haenszel|||This analysis was performed for usual activities.||||= 0.9579
70972439|NCT01885000|141451508|SUPERIORITY||||||=|0.1344|||||||Cochran-Mantel-Haenszel|||This analysis was performed for Pain/Discomfort.||||= 0.1344
70972440|NCT01885000|141451508|SUPERIORITY||||||=|0.1881|||||||Cochran-Mantel-Haenszel|||Anxiety/Depression||||= 0.1881
70972441|NCT01885000|141451509|SUPERIORITY||||||=|0.3935|||||||Cochran-Mantel-Haenszel|||||||= 0.3935
70972442|NCT01885000|141451510|SUPERIORITY||||||=|0.4162|||||||Cochran-Mantel-Haenszel|||||||= 0.4162
70972443|NCT03124784|141451515|EQUIVALENCE|ARMS\<= 3 %SpO2 Error per International Organization For Standardization (ISO) -80601-2-61 Pilot study Monte Carlo simulation provided 80% Power with 25 subjects for an expected ARMS\< 3 % SpO2.|ARMS|0.0|||||TWO_SIDED|||||||||Accuracy Root Mean Square (ARMS)|Per ISO-80601-2-61, the Root Mean Square difference (SpO2-SaO2) is the measure of merit for desaturation studies.|||
70972444|NCT05726318|141451562|SUPERIORITY|||||||0.78|||||||Chi-squared|||||||.78
70972445|NCT05726318|141451564|SUPERIORITY|||||||0.78|||||||Chi-squared|||||||.78
70972446|NCT05726318|141451565|SUPERIORITY|||||||0.68|||||||Chi-squared|||||||.68
70972447|NCT05726318|141451567|SUPERIORITY|||||||0.78|||||||Chi-squared|||||||.78
70972448|NCT05726318|141451568|SUPERIORITY|||||||0.13|||||||Chi-squared|||||||0.13
70972449|NCT01081795|141451602|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.4||||0.1646|TWO_SIDED|95.0|-1.0|0.2||Analysis of covariance (ANCOVA) method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.2|-1.0|0.1646
70919499|NCT00232180|141329658|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.789||||0.4213|TWO_SIDED|95.0|0.443|1.406||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||1.406|0.443|0.4213
70919500|NCT00232180|141329659|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.994||||0.9754|TWO_SIDED|95.0|0.694|1.424||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||1.424|0.694|0.9754
70919501|NCT00232180|141329660|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.2652|TWO_SIDED|95.0|0.485|1.22||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||1.220|0.485|0.2652
70919502|NCT00232180|141329661|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.971||||0.9537|TWO_SIDED|95.0|0.366|2.578||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||2.578|0.366|0.9537
70919503|NCT00232180|141329662|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.154||||0.8539|TWO_SIDED|95.0|0.251|5.312||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||5.312|0.251|0.8539
70919504|NCT00232180|141329663|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.585||||0.0175|TWO_SIDED|95.0|0.376|0.91||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.910|0.376|0.0175
70919505|NCT00232180|141329664|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.885||||0.6009|TWO_SIDED|95.0|0.559|1.4||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||1.400|0.559|0.6009
70919506|NCT01951170|141329684|SUPERIORITY_OR_OTHER|||||||0.83||||||Change in mTSS scores from baseline to Week 24.|Wilcoxon signed rank test|||||||0.83
70919507|NCT01305252|141329706|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.03
70919508|NCT01305252|141329706|SUPERIORITY_OR_OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
70972450|NCT01081795|141451602|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.4479|TWO_SIDED|95.0|-0.8|0.4||ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.4|-0.8|0.4479
70972451|NCT01081795|141451603|SUPERIORITY_OR_OTHER||LS mean difference|-0.5||||0.1547|TWO_SIDED|95.0|-1.1|0.2||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.2|-1.1|0.1547
70972452|NCT01081795|141451603|SUPERIORITY_OR_OTHER||LS mean difference|-0.4||||0.2624|TWO_SIDED|95.0|-1.0|0.3||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.3|-1.0|0.2624
70972453|NCT01081795|141451604|SUPERIORITY_OR_OTHER||LS mean difference|-0.4||||0.2464|TWO_SIDED|95.0|-1.0|0.3||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.3|-1.0|0.2464
70972454|NCT01081795|141451604|SUPERIORITY_OR_OTHER||LS mean difference|-0.3||||0.3148|TWO_SIDED|95.0|-1.0|0.3||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.3|-1.0|0.3148
71094091|NCT01922011|141695932|SUPERIORITY_OR_OTHER||Common difference|-10.5||||0.23|TWO_SIDED|95.0|-26.3|5.4|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|Overall Baseline Infecting Pathogen||5.4|-26.3|0.230
70919509|NCT01305252|141329709|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.03
70919510|NCT01305252|141329709|SUPERIORITY_OR_OTHER|||||||0.33|||||||t-test, 2 sided|||||||0.33
70919511|NCT04512482|141329712|SUPERIORITY|||||||0.044|||||||ANOVA|||A power analysis determined that a sample size of forty-five (45) subjects would possess 90% power to detect an effect size of 0.5 between the intervention and control legs of the crossover design. With 43 total subjects the study had between 85 and 90% power.||||.044
70919512|NCT00774397|141329716|SUPERIORITY_OR_OTHER|||||||0.0537||95.0||||P-value based on Fisher's exact test (2-sided)|Fisher Exact|||||||0.0537
71094092|NCT01922011|141695932|SUPERIORITY_OR_OTHER||Common difference|-12.3||||0.164|TWO_SIDED|95.0|-28.5|4.4|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|SA||4.4|-28.5|0.164
70919513|NCT00774397|141329716|SUPERIORITY_OR_OTHER|||||||0.0213||||||P-value based on Fisher's exact test (2-sided)|Fisher Exact|||||||0.0213
70919514|NCT00774397|141329716|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value based on Fisher's exact test (2-sided)|Fisher Exact|||||||<0.0001
70972455|NCT01081795|141451605|SUPERIORITY_OR_OTHER||LS mean difference|0.0||||0.8762|TWO_SIDED|95.0|-0.6|0.5||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.5|-0.6|0.8762
70972456|NCT01081795|141451605|SUPERIORITY_OR_OTHER||LS mean difference|-0.3||||0.3031|TWO_SIDED|95.0|-0.8|0.3||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.3|-0.8|0.3031
70972457|NCT01081795|141451606|SUPERIORITY_OR_OTHER||LS mean difference|-0.3||||0.1145|TWO_SIDED|95.0|-0.7|0.1||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.1|-0.7|0.1145
70972458|NCT01081795|141451606|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.3971|TWO_SIDED|95.0|-0.6|0.2||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.2|-0.6|0.3971
70972459|NCT01081795|141451607|SUPERIORITY_OR_OTHER||LS mean difference|-0.5||||0.1866|TWO_SIDED|95.0|-1.3|0.3||ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.3|-1.3|0.1866
70919515|NCT00774397|141329716|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value based on Fisher's exact test (2-sided)|Fisher Exact|||||||<0.0001
70919516|NCT00774397|141329716|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value based on Fisher's exact test (2-sided)|Fisher Exact|||||||<0.0001
70972460|NCT01081795|141451607|SUPERIORITY_OR_OTHER||LS mean difference|-0.6||||0.1507|TWO_SIDED|95.0|-1.4|0.2||ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.2|-1.4|0.1507
70972461|NCT01081795|141451609|SUPERIORITY_OR_OTHER||LS mean difference|-0.4||||0.1743|TWO_SIDED|95.0|-1.0|0.2||ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.2|-1.0|0.1743
70972462|NCT01081795|141451609|SUPERIORITY_OR_OTHER||LS mean difference|-0.4||||0.2165|TWO_SIDED|95.0|-1.0|0.2||ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.2|-1.0|0.2165
70972463|NCT01081795|141451610|SUPERIORITY_OR_OTHER||Percentage difference|5.1||||0.3083|TWO_SIDED|95.0|-3.8|14.0||Month 6|Fisher Exact|||||14.0|-3.8|0.3083
70972464|NCT01081795|141451610|SUPERIORITY_OR_OTHER||Percentage difference|2.0||||0.7235|TWO_SIDED|95.0|-6.6|10.6||Month 6|Fisher Exact|||||10.6|-6.6|0.7235
71094093|NCT01922011|141695932|SUPERIORITY_OR_OTHER||Common difference|-15.5||||0.043|TWO_SIDED|95.0|-31.2|1.1|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|MSSA||1.1|-31.2|0.043
70919517|NCT00774397|141329716|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value based on Fisher's exact test (2-sided)|Fisher Exact|||||||<0.0001
70919518|NCT00077675|141329747|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was selected on the basis of clinical judgment and was deemed adequate to provide clinically meaningful descriptive results consistent with study objectives. This sample size was estimated to provide 91% power to test telavancin's non-inferiority to vancomycin with respect to clinical response using a non-inferiority margin of 20%||||||0.5318|||||||2-sided 95% confidence interval calculat|||95% Confidence Interval: -0.0527 to 0.1102 No estimated value Parameter that was estimated: Risk Difference||||0.5318
70919519|NCT03873337|141329847|SUPERIORITY||||||<|0.001||||||not adjusted for multiple comparisons|t-test, 1 sided|df = 25||One-tailed, paired sample t-tests will be used to examine decreases in scores on the TASQ at one-month post target quit date (2-months after baseline assessment.||||<0.001
70919520|NCT03873337|141329847|SUPERIORITY|||||||0.002||||||not adjusted for multiple comparisons|t-test, 1 sided|df = 27||One-tailed, paired sample t-tests will be used to examine decreases in scores on the TASQ at 3-months post target quit date (4 months after baseline assessment.||||0.002
70919521|NCT03873337|141329848|SUPERIORITY||||||<|0.001||||||not adjusted for multiple comparisons|t-test, 1 sided|df = 27||One-tailed, paired sample t-tests will be used to examine decreases in cigarettes smoked per day at one-month post target quit date (2-months after baseline assessment.||||<0.001
70919522|NCT03873337|141329848|SUPERIORITY||||||<|0.001||||||not adjusted for multiple comparisons|t-test, 1 sided|df = 27||One-tailed, paired sample t-tests will be used to examine decreases in cigarettes smoked per day at 3-months post target quit date (4-months after baseline assessment.||||<0.001
70919523|NCT03292913|141329884|SUPERIORITY||Risk Ratio (RR)|1.07||||0.22|TWO_SIDED|95.0|0.96|1.21|||Mixed Models Analysis|Risk ratio is adjusted for sex, age, race, site, viral load suppression at baseline, and new to care.||Outcome measure for this analysis is viral load suppression. A priori threshold for statistical significance is p-value less than 0.05.||1.21|0.96|0.220
70919524|NCT03292913|141329885|SUPERIORITY||Risk Ratio (RR)|1.04||||0.481|TWO_SIDED|95.0|0.94|1.15|||Mixed Models Analysis|Risk ratio is adjusted for sex, age, race, site, and new to care.||Outcome measure for this analysis is retention in care. A priori threshold for statistical significance is p-value less than 0.05.||1.15|0.94|0.481
70919525|NCT03292913|141329886|SUPERIORITY||Risk Ratio (RR)|0.86||||0.093|TWO_SIDED|95.0|0.72|1.03|||Mixed Models Analysis|Risk ratio is adjusted for sex, age, race, site, and new to care.||Outcome measure for this analysis is a 6-month visit gap defined ashaving at least 189 days between two sequentially kept visits, post-randomization. A priori threshold for statistical significance is p-value less than 0.05.||1.03|0.72|0.093
70972465|NCT01707693|141451650|SUPERIORITY|repeated measures mixed model analysis of covariance, with the baseline measurement as a covariate.||||||0.023||||||P-value calculated from repeated measures model adjusting for age with a log transformation applied. P-values are one-sided.|ANCOVA|||||||0.023
70972466|NCT01707693|141451651|SUPERIORITY|||||||0.011||||||\* P-value calculated from repeated measures model adjusting for age with a log transformation applied.|ANCOVA|\* P-value calculated from repeated measures model adjusting for age with a log transformation applied.||||||0.011
70972467|NCT01707693|141451652|OTHER|2-sided Wilcoxon Rank Sum test||||||0.033|||||||Wilcoxon (Mann-Whitney)|||||||0.033
70972468|NCT01707693|141451653|OTHER|counts of stage of change||||||0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Armitage trend test||||||.001
70972469|NCT01459705|141451657|SUPERIORITY_OR_OTHER||Slope|-22.34|STANDARD_DEVIATION|4.69|||ONE_SIDED|||||||||||||
70972470|NCT01459705|141451657|SUPERIORITY_OR_OTHER||Slope|-13.3|STANDARD_ERROR_OF_MEAN|4.77|||TWO_SIDED|||||||||||||
70972471|NCT01459705|141451657|SUPERIORITY_OR_OTHER||Slope|9.04|STANDARD_ERROR_OF_MEAN|5.11|||TWO_SIDED|||||||||||||
70972472|NCT01459705|141451658|SUPERIORITY_OR_OTHER||Slope|15.07|STANDARD_DEVIATION|6.03|||TWO_SIDED|||||||||||||
70972473|NCT01459705|141451659|SUPERIORITY_OR_OTHER||Slope|13.91|STANDARD_ERROR_OF_MEAN|6.7|||TWO_SIDED|||||||||||||
70972474|NCT01967537|141451746|SUPERIORITY|||||||0.23|||||||Mann-Whitney|||||||0.23
70919526|NCT03950622|141329887|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-2.4||||0.175|TWO_SIDED|95.0|-5.8|1.1|||Miettinen & Nurminen|||Injection site redness/erythema||1.1|-5.8|0.175
70919527|NCT03950622|141329887|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|11.7|||<|0.001|TWO_SIDED|95.0|6.0|17.2|||Miettinen & Nurminen|||Injection site tenderness/pain||17.2|6.0|<0.001
70919528|NCT03950622|141329887|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|1.3||||0.488|TWO_SIDED|95.0|-2.4|5.0|||Miettinen & Nurminen|||Injection site swelling||5.0|-2.4|0.488
70919529|NCT03950622|141329888|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-0.2||||0.888|TWO_SIDED|95.0|-2.8|2.4|||Miettinen & Nurminen|||Joint pain/arthralgia||2.4|-2.8|0.888
70972475|NCT05130463|141451750|OTHER|||||||0.0011||||||Comparison of the change in HbA1c from baseline to the values at 12 weeks post Esgliteo administration.|t-test, 2 sided|||||||0.0011
70972476|NCT05130463|141451751|OTHER|||||||0.0014||||||Comparison of the change in HbA1c from baseline to the values at 24 weeks post Esgliteo administration.|t-test, 2 sided|||||||0.0014
70972477|NCT05130463|141451756|OTHER|||||||0.0008||||||Comparison of the change in FPG from baseline to the values at 12 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||FPG at baseline vs FPG after 12 weeks of treatment.||||0.0008
70972478|NCT05130463|141451757|OTHER|||||||0.0068||||||Comparison of the change in FPG from baseline to the values at 24 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||FPG at baseline vs FPG after 24 weeks of treatment.||||0.0068
70972479|NCT05130463|141451758|OTHER|||||||0.1867||||||Comparison of the change in body weight from baseline to the values at 12 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level||Body weight at baseline vs Body weight after 12 weeks of treatment.||||0.1867
70972480|NCT05130463|141451759|OTHER|||||||0.0003||||||Comparison of the change in body weight from baseline to the values at 24 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||Body weight at baseline vs Body weight after 24 weeks of treatment.||||0.0003
71094094|NCT01922011|141695932|SUPERIORITY_OR_OTHER|||||||0.45|||||||Wald|||MRSA||||0.450
71094095|NCT01922011|141695932|SUPERIORITY_OR_OTHER|||||||0.28|||||||Wald|||Other Pathogen||||0.280
71154051|NCT04516967|141800532|SUPERIORITY|||||||0.0008|||||||Fisher Exact|||||||0.0008
70919530|NCT03950622|141329888|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.1||||0.96|TWO_SIDED|95.0|-4.2|4.4|||Miettinen & Nurminen|||Tiredness/fatigue||4.4|-4.2|0.960
70919531|NCT03950622|141329888|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-1.4||||0.469|TWO_SIDED|95.0|-5.1|2.4|||Miettinen & Nurminen|||Headache||2.4|-5.1|0.469
70972481|NCT05130463|141451760|OTHER|||||||0.002||||||Comparison of the change in SBP from baseline to the values at 12 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||SBP at baseline vs SBP after 12 weeks of treatment.||||0.0020
70972482|NCT05130463|141451760|OTHER|||||||0.0132||||||Comparison of the change in DBP from baseline to the values at 12 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||DBP at baseline vs DBP after 12 weeks of treatment.||||0.0132
70972483|NCT05130463|141451761|OTHER|||||||0.7591||||||Comparison of the change in SBP from baseline to the values at 24 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||SBP at baseline vs SBP after 24 weeks of treatment.||||0.7591
70972484|NCT05130463|141451761|OTHER|||||||0.5161||||||Comparison of the change in DBP from baseline to the values at 24 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||DBP at baseline vs DBP after 24 weeks of treatment.||||0.5161
70972485|NCT03461757|141451762|SUPERIORITY||Risk Difference (RD)|10.4|||<|0.0001|TWO_SIDED|95.0|6.5|14.2|||Cochran-Mantel-Haenszel|||||14.2|6.5|< 0.0001
71154052|NCT04516967|141800533|SUPERIORITY|||||||0.7175|||||||Fisher Exact|||||||0.7175
71094096|NCT01922011|141695933|SUPERIORITY_OR_OTHER||Common difference|-6.3||||0.272|TWO_SIDED|95.0|-18.2|5.5|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|EOT||5.5|-18.2|0.272
71094097|NCT01922011|141695933|SUPERIORITY_OR_OTHER||Common difference|-4.8||||0.48|TWO_SIDED|95.0|-17.6|7.9|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|TOC||7.9|-17.6|0.480
71094098|NCT01922011|141695934|SUPERIORITY_OR_OTHER||Common difference|-10.1|||||TWO_SIDED|95.0|-24.8|4.2|||||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|Overall Baseline Infecting Pathogen||4.2|-24.8|
71094099|NCT01922011|141695934|SUPERIORITY_OR_OTHER||Common difference|-12.2|||||TWO_SIDED|95.0|-27.2|2.8|||||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|SA||2.8|-27.2|
71094100|NCT01922011|141695934|SUPERIORITY_OR_OTHER||Common difference|-10.4|||||TWO_SIDED|95.0|-25.4|5.2|||||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|MSSA||5.2|-25.4|
71094101|NCT02299167|141695948|OTHER|The ED50% of spinal bupivacaine was estimated using a modified Dixon's up-and-down method|Mean (95% CI) of effective dose in 90% (|1.9|||||TWO_SIDED|95.0|1.7|2.1|||||The ED50% of spinal bupivacaine was estimated using a modified Dixon's up-and-down method|Descriptive statistics were considered to calculate the mathematic mean (SD) of demographic, surgical, and other postoperative continuous data and to calculate the median (range) of sensory and motor block levels, as well as the degree of patient and surgeon satisfaction||2.1|1.7|
70919532|NCT03950622|141329888|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|3.4||||0.082|TWO_SIDED|95.0|-0.4|7.4|||Miettinen & Nurminen|||Muscle pain/myalgia||7.4|-0.4|0.082
70919533|NCT03950622|141329889|OTHER|Estimated differences and CIs are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-0.6|0.6|||Miettinen & Nurminen|||Vaccine-related SAEs||0.6|-0.6|
70919534|NCT03950622|141329890|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.66|0.96|||Constrained longitudinal data analysis|GMT ratio, 95% CI, and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||Serotype 1 (Shared)||0.96|0.66|<0.001
70919535|NCT03950622|141329890|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|1.6|||<|0.001|TWO_SIDED|95.0|1.38|1.85|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 3 (Shared)||1.85|1.38|<0.001
70919536|NCT03950622|141329890|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% CI of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.68|||<|0.001|TWO_SIDED|95.0|0.57|0.8|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 4 (Shared)||0.80|0.57|<0.001
70919537|NCT03950622|141329890|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.64|0.98|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 5 (Shared)||0.98|0.64|<0.001
70972486|NCT03461757|141451763|SUPERIORITY||Risk Difference (RD)|8.3||||0.0009|TWO_SIDED|95.0|3.4|13.2|||Cochran-Mantel-Haenszel|||||13.2|3.4|0.0009
71094102|NCT01035788|141696008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39|STANDARD_ERROR_OF_MEAN|7.24||0.849|TWO_SIDED|95.0|-1.39|13.2|||Mixed Models Analysis|p value was obtained from the contrast of the linear mixed model||We sought to obtain a sample size of 18 per group to provide 80% power to detect a .97 standard deviation difference in mean change in CAPS between MB-CBCT and the CBCT-Communication Skills at treatment end based on a two-tailed t-test at 5% significance. Linear mixed models with repeated measures were performed to address the primary hypotheses that MB-CBCT would result in a greater improvement for Veterans and their partners than CBCT-Communication Skills at the end of treatment.||13.2|-1.39|.849
71094103|NCT01001104|141696010|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the linear trend test at 12 weeks.|Mixed Models Analysis|||||||<.001
71094104|NCT01001104|141696010|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.72|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
71094105|NCT01001104|141696010|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.97|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
70919538|NCT03950622|141329890|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.84|1.19|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 6A (Shared)||1.19|0.84|<0.001
70919539|NCT03950622|141329890|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|1.23|||<|0.001|TWO_SIDED|95.0|1.02|1.48|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 6B (Shared)||1.48|1.02|<0.001
70972487|NCT03461757|141451764|SUPERIORITY||Risk Difference (RD)|16.1|||<|0.0001|TWO_SIDED|95.0|10.8|21.3|||Cochran-Mantel-Haenszel|||||21.3|10.8|< 0.0001
70972488|NCT03461757|141451765|SUPERIORITY||Risk Difference (RD)|20.1|||<|0.0001|TWO_SIDED|95.0|15.1|25.2|||Cochran-Mantel-Haenszel|||||25.2|15.1|< 0.0001
71094106|NCT01001104|141696010|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.17|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
71094107|NCT01001104|141696011|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value from the Cochran-Armitage trend test.|Cochran-Armitage|||||||<0.001
71094108|NCT01001104|141696011|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71094109|NCT01001104|141696011|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71094110|NCT01001104|141696011|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71094111|NCT01001104|141696012|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value from the Cochran-Armitage trend test.|Cochran-Armitage|||||||<0.001
71094112|NCT01001104|141696012|SUPERIORITY_OR_OTHER|||||||0.358||95.0|||||Fisher Exact|||||||0.358
71094113|NCT01001104|141696012|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Fisher Exact|||||||0.014
71094114|NCT01001104|141696012|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71094115|NCT01001104|141696013|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the linear trend test at week 12.|Mixed Models Analysis|||||||<0.001
71094116|NCT01001104|141696013|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-20.2||||0.003||95.0||||Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.|Mixed Models Analysis|||||||0.003
71094117|NCT01001104|141696013|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-19.54||||0.003||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||0.003
70919540|NCT03950622|141329890|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.68|0.9|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 7F (Shared)||0.90|0.68|<0.001
70919541|NCT03950622|141329890|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.81|||<|0.001|TWO_SIDED|95.0|0.7|0.94|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 9V (Shared)||0.94|0.70|<0.001
70919542|NCT03950622|141329890|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.75|||<|0.001|TWO_SIDED|95.0|0.64|0.89|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 14 (Shared)||0.89|0.64|<0.001
70919543|NCT03950622|141329890|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|1.07|||<|0.001|TWO_SIDED|95.0|0.91|1.26|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 18C (Shared)||1.26|0.91|<0.001
71094118|NCT01001104|141696013|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-28.48|||<|0.001||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||<0.001
71094119|NCT01001104|141696014|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the linear trend test at week 12.|Mixed Models Analysis|||||||<0.001
71094120|NCT01001104|141696014|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-33.2|||<|0.001||95.0||||Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.|Mixed Models Analysis|||||||<0.001
71094121|NCT01001104|141696014|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-45.63|||<|0.001||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||<0.001
71094122|NCT01001104|141696014|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-41.49|||<|0.001||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||<0.001
71094123|NCT01001104|141696015|SUPERIORITY_OR_OTHER|||||||0.987||95.0||||This is the p-value for the linear trend test at week 12.|Mixed Models Analysis|||||||0.987
71094124|NCT01001104|141696015|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.26||||0.005||95.0||||Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.|Mixed Models Analysis|||||||0.005
71094125|NCT01001104|141696015|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.45||||0.311||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||0.311
71094126|NCT01001104|141696015|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.26||||0.556||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||0.556
71094127|NCT01001104|141696016|SUPERIORITY_OR_OTHER|||||||0.202||95.0||||This is the p-value from the linear trend test at week 12.|Mixed Models Analysis|||||||0.202
71094128|NCT01001104|141696016|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.91||||0.917||95.0||||Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.|Mixed Models Analysis|||||||0.917
71094129|NCT01001104|141696016|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-9.81||||0.264||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||0.264
71094130|NCT01001104|141696016|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-8.4||||0.346||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||0.346
71094131|NCT01001104|141696017|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the linear trend test at week 12.|Mixed Models Analysis|||||||<0.001
71094132|NCT01001104|141696017|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|13.1||||0.036||95.0||||Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.|Mixed Models Analysis|||||||0.036
71094133|NCT01001104|141696017|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|19.73||||0.002||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||0.002
71094134|NCT01001104|141696017|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|31.68|||<|0.001||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||<0.001
71094135|NCT01001104|141696019|SUPERIORITY_OR_OTHER|||||||0.073||95.0||||This is the p-value from the Cochran-Armitage trend test (dose-effect).|Cochran-Armitage|||||||0.073
71094136|NCT01001104|141696019|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
71094137|NCT01001104|141696019|SUPERIORITY_OR_OTHER|||||||0.233||95.0|||||Fisher Exact|||||||0.233
71094138|NCT02397837|141696024|OTHER|||||||0.38|||||||t-test, 2 sided|||||||0.38
71094139|NCT02397837|141696025|OTHER|||||||0.22|||||||t-test, 2 sided|||||||0.22
71094140|NCT02397837|141696026|OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
71094141|NCT02397837|141696027|OTHER|||||||0.55|||||||t-test, 2 sided|||||||0.55
71094142|NCT02397837|141696028|OTHER|||||||0.99|||||||t-test, 2 sided|||||||0.99
71094143|NCT02397837|141696029|OTHER|||||||0.98|||||||t-test, 2 sided|||||||0.98
71094144|NCT02397837|141696030|OTHER||||||||||||||||||Tabulation of participants with suicidal acknowledgements over 12-week study|||
71094145|NCT02397837|141696031|OTHER|||||||0.09|||||||t-test, 2 sided|||||||0.09
71094146|NCT02397837|141696032|OTHER|||||||1|||||||t-test, 2 sided|||||||1.00
71094147|NCT02397837|141696033|OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
71094148|NCT01496456|141696056|SUPERIORITY_OR_OTHER|||||||0.002|||||||Regression, Logistic|Ordinal logistic regression, controlled for baseline lesion size and for correlation among pairs of teeth using the GEE method.||||||0.002
70919544|NCT03950622|141329890|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.8|||<|0.001|TWO_SIDED|95.0|0.7|0.93|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 19A (Shared)||0.93|0.70|<0.001
70919545|NCT03950622|141329890|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.88|||<|0.001|TWO_SIDED|95.0|0.76|1.02|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 19F (Shared)||1.02|0.76|<0.001
70919546|NCT03950622|141329890|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|1.18|||<|0.001|TWO_SIDED|95.0|0.96|1.44|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 23F (Shared)||1.44|0.96|<0.001
70919547|NCT03950622|141329890|SUPERIORITY|The statistical criterion for superiority requires the lower bound of the 2-sided 95% CI of the OPA GMT ratio \[V114/ Prevnar 13™\] to be greater than 2.0.|GMT Ratio|31.83|||<|0.001|TWO_SIDED|95.0|25.35|39.97|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 22F (Unique to V114)||39.97|25.35|<0.001
70919548|NCT03950622|141329890|SUPERIORITY|The statistical criterion for superiority requires the lower bound of the 2-sided 95% CI of the OPA GMT ratio \[V114/ Prevnar 13™\] to be greater than 2.0.|GMT Ratio|7.11|||<|0.001|TWO_SIDED|95.0|6.07|8.32|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 33F (Unique to V114)||8.32|6.07|<0.001
70919549|NCT03950622|141329891|SUPERIORITY|The statistical criterion for superiority requires the lower bound of the 2-sided 95% CI of the differences \[V114 - Prevnar 13™\] between the proportions of participants with a ≥4-fold rise from prevaccination \[Day 1\] to 30 days postvaccination \[Day 30\] to be greater than 0.1.|Percentage Point Difference|57.1|||<|0.001|TWO_SIDED|95.0|52.0|61.8|||Miettinen & Nurminen|Estimated difference, 95% CI, and p-value are based on the stratified Miettinen \& Nurminen method.||Serotype 22F (Unique to V114)||61.8|52.0|<0.001
70919550|NCT03950622|141329891|SUPERIORITY|The statistical criterion for superiority requires the lower bound of the 2-sided 95% CI of the differences \[V114 - Prevnar 13™\] between the proportions of participants with a ≥4-fold rise from prevaccination \[Day 1\] to 30 days postvaccination \[Day 30\] to be greater than 0.1)|Percentage Point Difference|50.5|||<|0.001|TWO_SIDED|95.0|45.9|54.9|||Miettinen & Nurminen|Estimated difference, 95% CI, and p-value are based on the stratified Miettinen \& Nurminen method.||Serotype 33F (Unique to V114)||54.9|45.9|<0.001
70919551|NCT03950622|141329892|SUPERIORITY|The statistical criterion for superiority requires the lower bound of the 2-sided 95% CI of the OPA GMT ratio \[V114/ Prevnar 13™\] to be greater than 1.2.|GMT Ratio|1.6|||<|0.001|TWO_SIDED|95.0|1.38|1.85|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 3 (Shared)||1.85|1.38|<0.001
70919552|NCT03950622|141329893|SUPERIORITY|The statistical criterion for superiority requires the lower bound of the 2-sided 95% CI of the difference(V114 - Prevnar 13™) between the proportions of participants with a ≥4-fold rise from prevaccination (Day 1) to 30 days postvaccination (Day 30) to be greater than 0.|Percentage Point Difference|11.5|||<|0.001|TWO_SIDED|95.0|6.0|16.9|||Miettinen & Nurminen|Estimated difference, 95% CI, and p-value are based on the stratified Miettinen \& Nurminen method.||Serotype 3 (Shared) ≥4-Fold Rise in OPA||16.9|6.0|<0.001
70919553|NCT03950622|141329894|OTHER|GMC ratio and 95% CI are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.72|||||TWO_SIDED|95.0|0.62|0.83||||||Serotype 1 (Shared)||0.83|0.62|
71094149|NCT01496456|141696057|SUPERIORITY_OR_OTHER|||||||0.045|||||||Regression, Logistic|Ordinal logistic regression, controlled for correlation among pairs of teeth using the GEE method.||||||0.045
71094150|NCT01496456|141696058|SUPERIORITY_OR_OTHER|||||||0.0077|||||||Discreet Time Survival Analysis|Controlled for correlation among tooth pairs (GEE model).||||||0.0077
71094151|NCT03010501|141696089|SUPERIORITY||||||<|0.0001||||||According to predefined comparisons, outcomes of the 80% and 120% Food Energy Density interventions were compared to the outcome of the baseline (100%) intervention.|Mixed Models Analysis|||||||< 0.0001
71094152|NCT03010501|141696090|SUPERIORITY|||||||0.1||||||According to predefined comparisons, intake by weight in the 80% intervention was compared to the 100% intervention.|Mixed Models Analysis|||||||0.10
70919554|NCT03950622|141329894|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.51|||||TWO_SIDED|95.0|1.33|1.71||||||Serotype 3 (Shared)||1.71|1.33|
70919555|NCT03950622|141329894|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.72|||||TWO_SIDED|95.0|0.62|0.83||||||Serotype 4 (Shared)||0.83|0.62|
70919556|NCT03950622|141329894|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.82|||||TWO_SIDED|95.0|0.7|0.96||||||Serotype 5 (Shared)||0.96|0.70|
70919557|NCT03950622|141329894|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.03|||||TWO_SIDED|95.0|0.87|1.21||||||Serotype 6A (Shared)||1.21|0.87|
71094153|NCT03010501|141696090|SUPERIORITY|||||||0.15||||||According to predefined comparisons, intake by weight in the 120% intervention was compared to the 100% intervention.|Mixed Models Analysis|||||||0.15
71094154|NCT03010501|141696091|SUPERIORITY||||||<|0.0001||||||According to predefined comparisons, outcomes of the 80% and 120% Food Energy Density interventions were compared to the outcome of the baseline (100%) intervention.|Mixed Models Analysis|||||||< 0.0001
71094155|NCT02583269|141696148|OTHER|||||||0.76|||||||ANOVA|||Overall FACT G score p value baseline to week 8||||0.76
71094156|NCT02583269|141696148|OTHER|||||||0.25|||||||ANOVA|||Fact G functional well being p value baseline to week 8||||0.25
71094157|NCT02583269|141696148|OTHER|||||||0.18|||||||ANOVA|||FACT G emotional well being p value baseline to week 8||||0.18
71094158|NCT02583269|141696148|OTHER|||||||0.87|||||||ANOVA|||Fact G physical well being p value baseline to week 8||||0.87
71094159|NCT02583269|141696148|OTHER|||||||0.22|||||||ANOVA|||Fact G social well being p value baseline to week 8||||0.22
71094160|NCT02583269|141696156|OTHER|||||||0.67|||||||ANOVA|||||||0.67
71094161|NCT02583269|141696157|OTHER|||||||0.119|||||||ANOVA|||Baseline v. 4 weeks log IL-8||||0.119
70972489|NCT03461757|141451766|SUPERIORITY||Risk Difference (RD)|20.1|||<|0.0001|TWO_SIDED|95.0|15.1|25.2|||Cochran-Mantel-Haenszel|||||25.2|15.1|< 0.0001
70972490|NCT03461757|141451767|SUPERIORITY||Risk Difference (RD)|9.3|||<|0.0001|TWO_SIDED|95.0|4.9|13.7|||Cochran-Mantel-Haenszel|||||13.7|4.9|< 0.0001
70972491|NCT03461757|141451768|SUPERIORITY||Risk Difference (RD)|-15.0|||<|0.0001|TWO_SIDED|95.0|-19.3|-10.7|||Cochran-Mantel-Haenszel|||||-10.7|-19.3|< 0.0001
70972492|NCT03461757|141451769|SUPERIORITY||Risk Difference (RD)|12.7|||<|0.0001|TWO_SIDED|95.0|8.3|17.2|||Cochran-Mantel-Haenszel|||||17.2|8.3|< 0.0001
70972493|NCT03461757|141451770|SUPERIORITY||Risk Difference (RD)|16.9|||<|0.0001|TWO_SIDED|95.0|12.0|21.9|||Cochran-Mantel-Haenszel|||||21.9|12.0|< 0.0001
70972494|NCT03461757|141451771|SUPERIORITY||Risk Difference (RD)|6.8||||0.0018|TWO_SIDED|95.0|2.5|11.0|||Cochran-Mantel-Haenszel|||||11.0|2.5|0.0018
70972495|NCT03461757|141451772|SUPERIORITY||Risk Difference (RD)|10.6|||<|0.0001|TWO_SIDED|95.0|6.3|14.9|||Cochran-Mantel-Haenszel|||||14.9|6.3|< 0.0001
70972496|NCT03461757|141451773|SUPERIORITY||Risk Difference (RD)|8.8||||0.0007|TWO_SIDED|95.0|3.7|13.9|||Cochran-Mantel-Haenszel|||||13.9|3.7|0.0007
70972497|NCT03461757|141451774|SUPERIORITY||Risk Difference (RD)|8.9||||0.0002|TWO_SIDED|95.0|4.3|13.6|||Cochran-Mantel-Haenszel|||||13.6|4.3|0.0002
70972498|NCT03461757|141451775|SUPERIORITY||Risk Difference (RD)|12.4|||<|0.0001|TWO_SIDED|95.0|7.1|17.6|||Cochran-Mantel-Haenszel|||||17.6|7.1|< 0.0001
71094162|NCT02583269|141696157|OTHER|||||||0.414|||||||ANOVA|||Baseline v. 8 weeks log IL-8||||0.414
70972499|NCT03461757|141451776|SUPERIORITY||Risk Difference (RD)|10.1|||<|0.0001|TWO_SIDED|95.0|6.9|13.4|||Cochran-Mantel-Haenszel|||||13.4|6.9|< 0.0001
70972500|NCT03461757|141451777|SUPERIORITY||Risk Difference (RD)|5.8||||0.0128|TWO_SIDED|95.0|1.2|10.4|||Cochran-Mantel-Haenszel|||||10.4|1.2|0.0128
70972501|NCT03461757|141451778|SUPERIORITY||Risk Difference (RD)|7.8|||<|0.0001|TWO_SIDED|95.0|4.4|11.1|||Cochran-Mantel-Haenszel|||||11.1|4.4|< 0.0001
70972502|NCT03461757|141451779|SUPERIORITY||Risk Difference (RD)|11.5||||0.0003|TWO_SIDED|95.0|5.3|17.7|||Cochran-Mantel-Haenszel|||||17.7|5.3|0.0003
70972503|NCT03461757|141451780|SUPERIORITY||Risk Difference (RD)|8.0|||<|0.0001|TWO_SIDED|95.0|4.9|11.1|||Cochran-Mantel-Haenszel|||||11.1|4.9|< 0.0001
70972504|NCT03461757|141451781|SUPERIORITY||Risk Difference (RD)|5.5||||0.0314|TWO_SIDED|95.0|0.5|10.6|||Cochran-Mantel-Haenszel|||||10.6|0.5|0.0314
71094163|NCT02583269|141696158|OTHER|||||||0.851|||||||ANOVA|||Baseline v. 4 weeks p value log VEGF||||0.851
70972505|NCT03461757|141451782|SUPERIORITY||Risk Difference (RD)|6.4||||0.0025|TWO_SIDED|95.0|2.3|10.6|||Cochran-Mantel-Haenszel|||||10.6|2.3|0.0025
70972506|NCT03461757|141451783|SUPERIORITY||Risk Difference (RD)|5.9||||0.0898|TWO_SIDED|95.0|-0.9|12.7||P-Value ≥ 0.05; therefore, all secondary endpoints listed after this endpoint in the hierarchy were not tested.|Cochran-Mantel-Haenszel|||||12.7|-0.9|0.0898
70972507|NCT03861559|141451792|OTHER||||||<|0.01|||||||Log Rank|||||||<0.01
70972508|NCT03861559|141451793|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
70972509|NCT03861559|141451795|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
70972510|NCT03861559|141451796|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
70972511|NCT03861559|141451797|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
70972512|NCT03861559|141451799|OTHER|||||||0.14|||||||ANOVA|||||||0.14
70972513|NCT03861559|141451800|OTHER|||||||0.02|||||||ANOVA|||||||0.02
70972514|NCT03861559|141451801|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
70972515|NCT03861559|141451803|OTHER|||||||0.15|||||||ANOVA|||||||0.15
70972516|NCT03861559|141451804|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
70972517|NCT03861559|141451805|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
70972518|NCT03861559|141451807|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
70972519|NCT03861559|141451808|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
70972520|NCT03861559|141451809|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
70972521|NCT03861559|141451810|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
70972522|NCT03861559|141451811|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
70972523|NCT03861559|141451812|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
70972524|NCT00720109|141451815|SUPERIORITY_OR_OTHER_LEGACY||Percentage|40.7|||<|0.001|TWO_SIDED|90.0|30.8|51.4|||Chi-squared|Chi-squared test equivalent to Z-test of proportions.||The a priori plan was to compare MRD positivity rate with that on a prior study, AALL0031 (n=72 Cohorts 1-5 of AALL0031 with 71% MRD positive). Out of 59 patients with end-Induction MRD on AALL0622, 40.7% were MRD positive. Per protocol, rates will be compared with a 2 sample Z-test of proportions, 1-sided test, alpha=5%.||51.4|30.8|<0.001
70972525|NCT00720109|141451816|SUPERIORITY_OR_OTHER_LEGACY||percentage|10.5|||=|0.13|TWO_SIDED|90.0|5.3|19.3|||Binomial Test||The pre-specified threshold for the estimated percentage of MRD positivity at End Consolidation was set to 16%. Results show an upper bound on the (Agresti-Coull) confidence interval of 19.3%.|||19.3|5.3|=0.13
70972526|NCT00903175|141451826|NON_INFERIORITY_OR_EQUIVALENCE|Primary objective was to assess the non-inferiority of everolimus as compared to Sunitinib in terms of PFS-1L \& was based on Bayesian methodology. If the estimated HR for PFS-1L had a value ≤ 1.1, non-inferiority of everolimus to Sunitinib would be declared. Non-inferiority of everolimus compared with Sunitinib as a first-line therapy was not achieved. The estimated HR for PFS-1L was 1.43 which did not satisfy the protocol-defined non-inferiority margin of a HR ≤ 1.1.|Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|1.15|1.77||||||||1.77|1.15|
71094164|NCT02583269|141696158|OTHER|||||||0.688|||||||ANOVA|||Baseline vs. 8 weeks p value log VEGF||||0.688
71094165|NCT04167670|141696246|NON_INFERIORITY|P-value based on a Farrington and Manning test with a noninferiority margin of 10%.|Percentage Difference|-0.3||||0.0037|TWO_SIDED|95.0|-7.39|6.76|||Farrington and Manning test||The confidence interval of the difference in H pylori eradication rates between vonoprazan dual therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method.|Noninferiority of vonoprazan dual therapy to lansoprazole triple therapy.||6.76|-7.39|0.0037
71094166|NCT04167670|141696246|NON_INFERIORITY|P-value based on a Farrington and Manning test with a noninferiority margin of 10%.|Percentage Difference|5.9|||<|0.0001|TWO_SIDED|95.0|-0.75|12.62|||Farrington and Manning test||The confidence interval of the difference in H pylori eradication rates between vonoprazan triple therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method.|Noninferiority of vonoprazan triple therapy to lansoprazole triple therapy.||12.62|-0.75|<0.0001
71094167|NCT04167670|141696247|SUPERIORITY|P-value based on a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|Percentage Difference|37.7|||<|0.0001|TWO_SIDED|95.0|20.54|52.56|||Farrington and Manning test||The confidence interval of the difference in H pylori eradication rates between vonoprazan dual therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method.|Superiority of vonoprazan dual therapy to lansoprazole triple therapy.||52.56|20.54|<0.0001
71094168|NCT04167670|141696247|SUPERIORITY|P-value based on a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|Percentage Difference|33.8|||<|0.0001|TWO_SIDED|95.0|17.74|48.12|||Farrington and Manning test||The confidence interval of the difference in H pylori eradication rates between vonoprazan triple therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method.|Superiority of vonoprazan triple therapy to lansoprazole triple therapy.||48.12|17.74|<0.0001
71094169|NCT04167670|141696248|SUPERIORITY|P-value based on a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|Percentage Difference|8.7||||0.0063|TWO_SIDED|95.0|1.86|15.44|||Farrington and Manning test||The confidence interval of the difference in H pylori eradication rates between vonoprazan dual therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method.|Superiority of vonoprazan dual therapy to lansoprazole triple therapy.||15.44|1.86|0.0063
71094170|NCT04167670|141696248|SUPERIORITY|P-value based on a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|Percentage Difference|12.3||||0.0001|TWO_SIDED|95.0|5.72|18.81|||Farrington and Manning test|||Superiority of vonoprazan triple therapy to lansoprazole triple therapy.|The confidence interval of the difference in H pylori eradication rates between vonoprazan triple therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method.|18.81|5.72|0.0001
71094171|NCT00876395|141696264|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.1166|TWO_SIDED|95.0|0.73|1.08|||Log Rank|||||1.08|0.73|0.1166
71094172|NCT00876395|141696265|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0049|TWO_SIDED|95.0|0.48|0.91|||Log Rank|||||0.91|0.48|0.0049
71094173|NCT00876395|141696268|SUPERIORITY|||||||0.7276|||||||Exact Cochran-Mantel-Haenzel chi-square|||||||0.7276
71094174|NCT00876395|141696269|SUPERIORITY|||||||0.4085|||||||Exact Cochran-Mantel-Haenzel chi-square|||||||0.4085
71094175|NCT00876395|141696270|SUPERIORITY|||||||0.9573|||||||Exact Cochran-Mantel-Haenzel chi-square|||||||0.9573
71094176|NCT00876395|141696271|SUPERIORITY|||||||0.6382|||||||Exact Cochran-Mantel-Haenzel chi-square|||||||0.6382
71094177|NCT03807843|141696282|OTHER||V184 GMFR/Placebo GMFR Ratio|1.6||||0.004|TWO_SIDED|95.0|1.2|2.1|||Mixed Effects Model|||"Day 28 V184 GMFR/Placebo GMFR Ratio~The ratio of V184 GMFR/Placebo GMFR at Day 28 was derived from the mixed effects model used to determine GMFR."||2.1|1.2|0.004
70919558|NCT03950622|141329894|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.39|||||TWO_SIDED|95.0|1.17|1.64||||||Serotype 6B (Shared)||1.64|1.17|
70919559|NCT03950622|141329894|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.76|||||TWO_SIDED|95.0|0.66|0.89||||||Serotype 7F (Shared)||0.89|0.66|
71094178|NCT03807843|141696282|OTHER||V184 GMFR/Placebo GMFR Ratio|2.1|||<|0.001|TWO_SIDED|95.0|1.5|2.8|||Mixed Effects Model|||"Day 56 V184 GMFR/Placebo GMFR Ratio~The ratio of V184 GMFR/Placebo GMFR at Day 56 was derived from the mixed effects model used to determine GMFR."||2.8|1.5|<0.001
71094179|NCT03807843|141696282|OTHER||V184 GMFR/Placebo GMFR Ratio|1.3||||0.121|TWO_SIDED|95.0|0.9|1.7|||Mixed Effects Model|||"Day 196 V184 GMFR/Placebo GMFR Ratio~The ratio of V184 GMFR/Placebo GMFR at Day 196 was derived from the mixed effects model used to determine GMFR."||1.7|0.9|0.121
71094180|NCT01312129|141696285|SUPERIORITY_OR_OTHER||||||=|0.05|TWO_SIDED|||||=0.05 is the actual computed p-value via the ANOVA.|ANOVA|The ANOVA is comparing the % increase in BOLD response above baseline during cue presentation (Alcohol vs. Control) b/w placebo \& Sulfasalazine .||||||=.05
71094181|NCT00924651|141696289|OTHER||Mean Difference (Final Values)|-0.01916|STANDARD_ERROR_OF_MEAN|0.1791||0.9148|TWO_SIDED|95.0|-0.371|0.3327|||ANCOVA|||||0.3327|-0.3710|0.9148
71094182|NCT02034591|141696307|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.682|||||TWO_SIDED|90.0|0.621|0.748||||||||0.748|0.621|
71094183|NCT02034591|141696308|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.813|||||TWO_SIDED|90.0|0.766|0.863||||||||0.863|0.766|
71094184|NCT02034591|141696309|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.81|||||TWO_SIDED|90.0|0.764|0.86||||||||0.860|0.764|
71094185|NCT02034591|141696310|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.884|||||TWO_SIDED|90.0|0.83|0.942||||||||0.942|0.830|
71094186|NCT02034591|141696311|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.95|||||TWO_SIDED|90.0|0.905|0.997||||||||0.997|0.905|
71094187|NCT02034591|141696312|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.947|||||TWO_SIDED|90.0|0.903|0.994||||||||0.994|0.903|
71094188|NCT04307394|141696321|SUPERIORITY|||||||0.957|||||||t-test, 2 sided|||||||0.957
71094189|NCT01121926|141696322|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax,ss is between 80% and 125%.|Mean ratio|56.53|||||TWO_SIDED|90.0|49.99|63.94|||||Test/reference (%)|||63.94|49.99|
70919560|NCT03950622|141329894|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.86|||||TWO_SIDED|95.0|0.75|1.0||||||Serotype 9V (Shared)||1.00|0.75|
70919561|NCT03950622|141329894|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.76|||||TWO_SIDED|95.0|0.65|0.89||||||Serotype 14 (Shared)||0.89|0.65|
70919562|NCT03950622|141329894|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.9|||||TWO_SIDED|95.0|0.77|1.05||||||Serotype 18C (Shared)||1.05|0.77|
71094190|NCT01121926|141696323|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUCss is between 80% and 125%.|Mean ratio|85.72|||||TWO_SIDED|90.0|81.05|90.67|||||Test/reference (%)|||90.67|81.05|
71094191|NCT01201863|141696388|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.07816|STANDARD_ERROR_OF_MEAN|1.3315||0.954|TWO_SIDED||||||comparison of slopes|Slopes by group and slope difference||To investigate a difference in change in outcome over time between treatment and control, a trend analysis was used in place of a profile analysis, where both control and treatment arms are described more parsimoniously i.e. by a slope (change in outcome over time) (Fitzmaurice 2011).||||0.9540
70919563|NCT03950622|141329894|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.73|0.97||||||Serotype 19A (Shared)||0.97|0.73|
70919564|NCT03950622|141329894|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.9|||||TWO_SIDED|95.0|0.78|1.05||||||Serotype 19F (Shared)||1.05|0.78|
70919565|NCT03950622|141329894|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.09|||||TWO_SIDED|95.0|0.92|1.28||||||Serotype 23F (Shared)||1.28|0.92|
70919566|NCT03950622|141329894|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|10.62|||||TWO_SIDED|95.0|9.37|12.03||||||Serotype 22F (Unique to V114)||12.03|9.37|
70919567|NCT03950622|141329894|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|8.98|||||TWO_SIDED|95.0|8.0|10.07||||||Serotype 33F (Unique to V114)||10.07|8.00|
70919568|NCT03752151|141329899|SUPERIORITY||||||<|0.001|||||||McNemar|||The null hypothesis was that the probability of meeting the endpoint (Atrioventricular synchrony \>70%) was the same in MARVEL 2 Monitor Mode and MARVEL 2 Adaptive Mode. A sample size of 35 participants with a predominant rhythm of 3rd degree atrioventricular block and normal sinus function provided \>90% power at a type I error rate of 0.05 assuming the proportion of patients meeting the endpoint in one mode, but not the other exceeded 50% and 90% of these pairs favored the Adaptive mode.||||<0.001
70919569|NCT03752151|141329900|SUPERIORITY||proportion expressed as a percentage|100.0|||<|0.001|TWO_SIDED|95.0|95.2|100.0|||Exact binomial test|||The null hypothesis is that 87% or fewer participants will achieve the endpoint. The alternative hypothesis is that more than 87% of participants will achieve the endpoint. A sample size of 70 participants provides at least 90% power to test the null hypothesis assuming the true rate of meeting the endpoint in the population is 98% at a type I error rate of 2.5%.||100|95.2|<0.001
70919570|NCT03752151|141329901|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.002|TWO_SIDED|95.0|0.7|2.7|||t-test, 2 sided|Paired t-test since each participant had LVOT VTI measurements in MARVEL 2 Adaptive and Monitor modes||The null hypothesis is that the mean LVOT VTI during MARVEL 2 Adaptive mode equals the mean LVOT VTI during MARVEL 2 Monitor mode. A sample size of 35 participants with paired LVOT VTI measurements provides 89% power at a type I error rate of 5% to reject the null hypothesis assuming the true difference in LVOT VTI is 2.1 cm with a standard deviation of 3.8 cm.||2.7|0.7|0.002
70919571|NCT04247074|141329942|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70919572|NCT04247074|141329943|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70919573|NCT04247074|141329944|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70919574|NCT04247074|141329945|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70919575|NCT01849055|141329982|SUPERIORITY||Mean Difference (Final Values)|-1.22|||||TWO_SIDED|90.0|-4.98|2.54||||||SBP||2.54|-4.98|
70919576|NCT01849055|141329982|SUPERIORITY||Mean Difference (Final Values)|-1.09|||||TWO_SIDED|90.0|-4.7|2.53||||||SBP||2.53|-4.70|
70919577|NCT01849055|141329982|SUPERIORITY||Mean Difference (Final Values)|-1.54|||||TWO_SIDED|90.0|-5.3|2.22||||||SBP||2.22|-5.30|
70919578|NCT01849055|141329982|SUPERIORITY||Mean Difference (Final Values)|-1.53|||||TWO_SIDED|90.0|-5.16|2.1||||||SBP||2.10|-5.16|
70919579|NCT01849055|141329982|SUPERIORITY||Mean Difference (Final Values)|-3.84|||||TWO_SIDED|90.0|-7.74|0.07||||||SBP||0.07|-7.74|
70919580|NCT01849055|141329982|SUPERIORITY||Mean Difference (Final Values)|-0.38|||||TWO_SIDED|90.0|-2.95|2.18||||||DBP||2.18|-2.95|
70919581|NCT01849055|141329982|SUPERIORITY||Mean Difference (Final Values)|-1.11|||||TWO_SIDED|90.0|-3.69|1.48||||||DBP||1.48|-3.69|
70919582|NCT01849055|141329982|SUPERIORITY||Mean Difference (Final Values)|-0.95|||||TWO_SIDED|90.0|-3.75|1.85||||||DBP||1.85|-3.75|
70919583|NCT01849055|141329982|SUPERIORITY||Mean Difference (Final Values)|-1.49|||||TWO_SIDED|90.0|-4.09|1.1||||||DBP||1.10|-4.09|
70919584|NCT01849055|141329982|SUPERIORITY||Mean Difference (Final Values)|-2.51|||||TWO_SIDED|90.0|-5.23|0.2||||||DBP||0.20|-5.23|
70919585|NCT03122886|141330037|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.9|TWO_SIDED|95.0|0.12|6.37|||Log Rank|||||6.37|0.12|0.90
70919586|NCT03779048|141330040|OTHER|Regression using baseline scores to predict 4-week weight loss during the behavioral treatment run-in. Primary prediction analysis presented below was pre-specified to evaluate together postprandial satiety, postprandial increases in GLP-1 and gastric emptying (acetaminophen tests) and includes only the 125 participants from whom baseline blood samples could be obtained.|Standardized Beta coefficient|0.11||||0.24|TWO_SIDED||||||Regression, Linear|Controls for postprandial increases in GLP-1 and gastric emptying (acetaminophen tests)||||||.24
70919587|NCT03779048|141330041|OTHER|Regression using baseline scores to predict 4-week weight loss during the behavioral treatment run-in. Primary prediction analysis presented below was pre-specified to evaluate together postprandial satiety, postprandial increases in GLP-1 and gastric emptying (acetaminophen tests) and includes only the 125 participants from whom baseline blood samples could be obtained.|Standardized Beta coefficient|-0.09||||0.34|TWO_SIDED||||||Regression, Linear|Controls for baseline postprandial satiety and gastric emptying (acetaminophen test)||||||.34
70919588|NCT03779048|141330042|OTHER|Regression using baseline scores to predict 4-week weight loss during the behavioral treatment run-in. Primary prediction analysis presented below was pre-specified to evaluate together postprandial satiety, postprandial increases in GLP-1 and gastric emptying (acetaminophen tests) and includes only the 125 participants from whom baseline blood samples could be obtained.|Standardized Beta coefficient|0.03||||0.78|TWO_SIDED||||||Regression, Linear|Controls for baseline postprandial satiety and postprandial change in GLP-1||||||.78
70919589|NCT03779048|141330043|SUPERIORITY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|1.0||0.003|TWO_SIDED|95.0|1.1|5.1|||Mixed Models Analysis|||||5.1|1.1|.003
70919590|NCT03779048|141330044|OTHER|Correlation between baseline postprandial hunger AUC and 4-week percent weight loss.|r|-0.1||||0.23|TWO_SIDED||||||Regression, Linear|||||||.23
70919591|NCT03779048|141330045|OTHER|Correlation between baseline high energy density food reinforcer points earned and 4-week percent weight loss.|r|-0.1||||0.23|TWO_SIDED||||||Regression, Linear|||||||.23
70919592|NCT03779048|141330046|OTHER|Regression results using baseline AUC for delay discounting to predict 4-week percent weight loss, controlling for participant age.|r2 change|0.033||||0.033|TWO_SIDED||||||Regression, Linear|||||||.033
70919593|NCT03779048|141330047|OTHER|Correlation between baseline implicit wanting and 4-week percent weight loss. Because categories are scored relative to each other they cannot be included together in the same analysis, so separate correlations were conducted.|r|0.17||||0.04|TWO_SIDED|||||Correlation to Implicit wanting of High Fat Savory.|Regression, Linear|||||||.04
71094192|NCT01149785|141696389|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|316.36|||||TWO_SIDED|90.0|286.17|349.73||||||Natural log transformed AUC (0-∞) of crizotinib was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||349.73|286.17|
70972527|NCT01687712|141451841|NON_INFERIORITY|Non-inferiority was demonstrated if the upper limit of the two-sided 95% CI of the difference in pregnancy rates (Gonal-f® RFF - AFOLIA) did not exceed 8% (i.e. a one-sided hypothesis test at the 2.5% level of significance). The difference in rates (\& Wald CI) was estimated using a logistic regression model with binomial distribution and identity link, with treatment and site as factors.|Risk Difference (RD)|3.7|||||TWO_SIDED|95.0|-1.3|8.7|||||"Note that risk in this context is the risk of clinical pregnancy. The difference is in the direction Gonal-f® RFF - AFOLIA."|"The null and alternative hypotheses are as follows:~H0: p2- p1 \> ∆ and H1: p2- p1 ≤ ∆,~where p1 is the clinical pregnancy rate in the AFOLIA treatment group, p2 is the clinical pregnancy rate in the Gonal f® treatment group, and Δ is the non-inferiority margin of 8%."||8.7|-1.3|
70972528|NCT01687712|141451842|NON_INFERIORITY|Non-inferiority was demonstrated if the upper limit of the two-sided 95% CI of the difference in pregnancy rates (Gonal-f® RFF - AFOLIA) did not exceed 8% (i.e. a one-sided hypothesis test at the 2.5% level of significance). The difference in rates (\& Wald CI) was estimated using a logistic regression model with binomial distribution and identity link, with treatment and site as factors.|Risk Difference (RD)|2.8|||||TWO_SIDED|95.0|-2.5|8.1|||||"Note that risk in this context is the risk of clinical pregnancy. The difference is in the direction Gonal-f® RFF - AFOLIA."|"The null and alternative hypotheses are as follows:~H0: p2- p1 \> ∆ and H1: p2- p1 ≤ ∆,~where p1 is the clinical pregnancy rate in the AFOLIA treatment group, p2 is the clinical pregnancy rate in the Gonal f® treatment group, and Δ is the non-inferiority margin of 8%."||8.1|-2.5|
70972529|NCT01687712|141451846|SUPERIORITY|Comparisons were tested against a null of zero at the two-side 5% significance level.||||||0.612||||||P-values are based upon Type III sums of squares.|ANCOVA|Treatment group and Site are included as factors.||"The null and alternative hypotheses are as follows:~H0: p2- p1 = 0 and H1: p2- p1 ≠0,~where p1 is the least squares adjusted mean number of oocytes retrieved in the AFOLIA treatment group and p2 is the least squares adjusted mean number of oocytes retrieved in the Gonal f® treatment group."||||0.612
70972530|NCT00970853|141451875|NON_INFERIORITY_OR_EQUIVALENCE|The original sample for this study (N=302) was sufficient for an 80% detection of differences in means of at least 1/2 standard deviation. This analysis presents the results of the follow-up of the original sample.||||||0.39||||||non-adjusted for multiple comparisons|t-test, 2 sided|||||||0.39
70972531|NCT00970853|141451876|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.99|||||||t-test, 2 sided|||||||.99
70972532|NCT00970853|141451877|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.16|||||||t-test, 2 sided|||||||0.16
70972533|NCT00970853|141451878|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.4|||||||t-test, 2 sided|||||||.40
70972534|NCT00970853|141451879|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.56|||||||t-test, 2 sided|||||||.56
70972535|NCT00970853|141451880|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.34|||||||t-test, 2 sided|||||||.34
71094193|NCT01149785|141696390|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|328.31|||||TWO_SIDED|90.0|296.42|363.63||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||363.63|296.42|
71094194|NCT01149785|141696393|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|144.13|||||TWO_SIDED|90.0|126.42|164.33||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||164.33|126.42|
70972536|NCT00970853|141451881|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.85|||||||t-test, 2 sided|||||||.85
70972537|NCT00970853|141451882|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.61|||||||t-test, 2 sided|||||||.61
70972538|NCT00970853|141451883|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.67|||||||t-test, 2 sided|||||||.67
71094195|NCT01149785|141696396|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|519.65|||||TWO_SIDED|90.0|460.42|586.5||||||Natural log transformed AUClast of crizotinib metabolite (PF-06260182) was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||586.50|460.42|
71094196|NCT01149785|141696397|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|516.98|||||TWO_SIDED|90.0|457.88|583.72||||||Natural log transformed AUC (0-∞) of crizotinib metabolite (PF-06260182) was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||583.72|457.88|
71094197|NCT01149785|141696399|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|161.42|||||TWO_SIDED|90.0|143.09|182.09||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||182.09|143.09|
71094198|NCT00898807|141696415|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.93||||0.036|TWO_SIDED|95.0|-1.8|-0.06||P-value was not adjusted for multiple comparisons. All p-values are two-sided and p\<0.05 was the threshold for statistical significance.|Mixed Models Analysis|Mixed effects model w/ random intercept for patient, visit indicator, treatment by visit interactions and adjusted for baseline NBRS-A \& cognition.|Negative numbers favor citalopram group.|Primary assessment of efficacy was based on intention-to-treat comparison of the difference in the NBRS-A scores at week 9 and comparison at week 9 for the CGIC. For the NBRS-A, the study was designed to have 85% power to detect a standardized difference at week 9 of 40% for citalopram compared to placebo at week 9.||-0.06|-1.80|0.036
71094199|NCT00898807|141696416|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13||||0.007|TWO_SIDED|95.0|1.23|3.69||All p-values are two-sided and p \<0.05 was the threshold for statistical significance. No adjustments were made for multiple comparisons.|Proportional odds|estimated treatment effect from the proportional odds model|Positive numbers favors citalopram.|Primary assessment of efficacy was based on intention-to-treat comparison of the difference in the NBRS-A scores at week 9 and comparison at week 9 for the CGIC. For the CGIC proportional odds analysis, the study was designed to have power greater than 80% to detect a difference of 20% between citalopram and placebo in the proportions of patients who improve (or worsen).||3.69|1.23|0.007
71094200|NCT04919161|141696419|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Kruskal-Wallis|Due sample size differences and pairwise nature of the data, a Kruskal-Wallis was conducted.||Null hypothesis for this analysis is that there will be no differences between pre-scores and post-scores across the different treatment arms. Prior to hypothesis testing, datasets were tested for normality using a Shapiro-Wilk test to inform if parametric or non-parametric testing was required.||||<0.0001
70972539|NCT06142643|141451889|OTHER|"A responder was defined by subjects with a score 1 (very much improved), 2 (much improved) or 3 (improved) on the GAIS.~Inferential analysis for the primary evaluation criterion For the derived outcome responder rate at M1 (1 month after injection) for the GAIS Investigator, a binomial exact test (bilateral approach) vs 60% was applied for the overall score. This test compared the proportion of improvement to 60%."|||||<|0.0001||||||Power of 80%, significant result (alpha = 5%).|t-test, 2 sided|Null hypothesis stated that less than 60% of subjects were responders with GAIS. Under the alternative hypothesis, 75% of subjects were responders.||||||<0.0001
70972540|NCT06142643|141451890|OTHER|"A responder was defined by subjects with a score 1 (very much improved), 2 (much improved) or 3 (improved) on the GAIS.~Inferential analysis for the primary evaluation criterion For the derived outcome responder rate at M1 (1 month after injection) for the GAIS Investigator, a binomial exact test (bilateral approach) vs 60% was applied for the overall score. This test compared the proportion of improvement to 60%."|||||<|0.0001||||||Power of 80%, significant result (alpha = 5%).|t-test, 2 sided|Null hypothesis stated that less than 60% of subjects were responders with GAIS. Under the alternative hypothesis, 75% of subjects were responders.||||||<0.0001
71094201|NCT04919161|141696419|SUPERIORITY||||||=|0.0025||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||=0.0025
71094202|NCT04919161|141696419|SUPERIORITY||||||=|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||=0.0001
71094203|NCT04919161|141696419|SUPERIORITY||||||>|0.9999||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||>0.9999
71094204|NCT04919161|141696419|SUPERIORITY||||||>|0.9999||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison would be that there would be no significant difference between post-scores of the two treatment groups.||||>0.9999
71094205|NCT04919161|141696420|SUPERIORITY|Prior to analysis, the score change or difference between post-test and pre-test were calculated for each participant as: ScoreChange=(PostTest) - (PreTest). These changes in score were then compared.|||||=|0.3045||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|t-test, 2 sided|||Null hypothesis is that there are no differences between groups. Prior to hypothesis testing, datasets were tested for normality using a Shapiro-Wilk test to inform if parametric or non-parametric testing was required.||||=0.3045
71094206|NCT04919161|141696421|SUPERIORITY|Prior to analysis, the score change or difference between post-test and pre-test were calculated for each participant as: PercentScoreChange = (\[(PostTest)-(PreTest)\]/\[PreTest\]) x 100%|||||=|3152||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Two-Tailed Welch t test|Due to unequal standard deviation, a two-tailed Welch's t test was used.||Null hypothesis is that there are no differences between groups. Prior to hypothesis testing, datasets were tested for normality using a Shapiro-Wilk test to inform if parametric or non-parametric testing was required.||||=3152
71094207|NCT04919161|141696422|SUPERIORITY||||||=|0.9568||||||Prior to analysis, the score change between post assessment and pre-assessment was calculated. The threshold for significance was p\<0.05.|t-test, 2 sided|An unpaired T-test was used. Normality and F-test for Variances were conducted and found to be normal.||Null hypothesis is that there are no differences between groups. Prior to hypothesis testing, datasets were tested for normality using a Shapiro-Wilk test to inform if parametric or non-parametric testing was required.||||=0.9568
71154053|NCT03570749|141800534|SUPERIORITY||Odds Ratio (OR)|5.75|||<|0.001|TWO_SIDED|95.0|2.75|12.02|||Regression, Logistic|||||12.02|2.75|<0.001
71154054|NCT03570749|141800534|SUPERIORITY||Odds Ratio (OR)|11.8|||<|0.001|TWO_SIDED|95.0|5.89|23.62|||Regression, Logistic|||||23.62|5.89|<0.001
70972541|NCT03485820|141451898|SUPERIORITY||Mean Difference (Net)|1.3||||0.76|TWO_SIDED|95.0|-7.1|9.6||P value shown is for group by time interaction.|Mixed Models Analysis||Between group differences in changes over time (COMPASS vs Education program)|A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression, number of days in inpatient rehabilitation, and baseline calendar time.||9.6|-7.1|0.76
70972542|NCT03485820|141451899|SUPERIORITY||Mean Difference (Net)|-1.8||||0.6|TWO_SIDED|95.0|-8.6|5.0||P value shown is for group by time interaction.|Mixed Models Analysis||Between group differences in changes over time (COMPASS vs Education program)|A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression, number of days in inpatient rehabilitation, and baseline calendar time.||5.0|-8.6|0.60
70972543|NCT03485820|141451900|SUPERIORITY||Mean Difference (Net)|-0.01||||0.83|TWO_SIDED|95.0|-0.06|0.05||P value shown is for group by time interaction.|Mixed Models Analysis||Between group differences in changes over time (COMPASS vs Education program)|A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression, number of days in inpatient rehabilitation, and baseline calendar time.||0.05|-0.06|0.83
70972544|NCT03485820|141451901|SUPERIORITY||Mean Difference (Net)|0.39||||0.046|TWO_SIDED|95.0|0.01|0.77||P value shown is for group by time interaction.|Mixed Models Analysis||Between group differences in changes over time (COMPASS vs Education program)|A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression , number of days in inpatient rehabilitation, and baseline calendar time.||0.77|0.01|0.046
70972545|NCT03485820|141451902|SUPERIORITY||Mean Difference (Net)|0.52||||0.02|TWO_SIDED|95.0|0.08|0.96||P value shown is for group by time interaction.|Mixed Models Analysis||Between group differences in changes over time (COMPASS vs Education program)|A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression, number of days in inpatient rehabilitation, and baseline calendar time.||0.96|0.08|0.02
70972546|NCT03485820|141451903|SUPERIORITY||Mean Difference (Net)|-10.6||||0.07|TWO_SIDED|95.0|-21.9|0.8||P value shown is for group by time interaction.|Mixed Models Analysis||Between group differences in changes over time (COMPASS vs Education program)|A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression, number of days in inpatient rehabilitation, and baseline calendar time.||0.8|-21.9|0.07
70972547|NCT04685876|141451904|SUPERIORITY|||||||0.355|||||||Regression, Linear|||||||0.355
70972548|NCT04685876|141451904|SUPERIORITY|||||||0.578|||||||Regression, Linear|||||||0.578
70972549|NCT04685876|141451906|SUPERIORITY|||||||0.248|||||||Regression, Cox|||||||0.248
71094208|NCT04919161|141696423|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Kruskal-Wallis|Due to the pairwise nature and abnormal distribution of the pre- and post-scores, a Kruskal Wallis test was completed.||Null Hypothesis, there would be no difference between the pre-score and post-score of each treatment group. Prior to hypothesis testing, datasets were tested for normality using a Shapiro-Wilk test to inform if parametric or non-parametric testing was required.||||<0.0001
70972550|NCT04685876|141451906|SUPERIORITY|||||||0.297|||||||Regression, Cox|||||||0.297
70972551|NCT04685876|141451907|SUPERIORITY|||||||0.748|||||||Mixed Models Analysis|||||||0.748
70972552|NCT04685876|141451907|SUPERIORITY|||||||0.395|||||||Mixed Models Analysis|||||||0.395
70972553|NCT04685876|141451908|SUPERIORITY|||||||0.152|||||||Regression, Linear|||||||0.152
70972554|NCT04685876|141451908|SUPERIORITY|||||||0.482|||||||Regression, Linear|||||||0.482
70972555|NCT00931359|141451909|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|Factors of treatment group and analysis center were considered||||||<0.001
70972556|NCT00931359|141451910|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||ANOVA|||||||0.019
70972557|NCT03809611|141451921|SUPERIORITY||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|1.77||0.1832|TWO_SIDED|90.0|-1.34|4.56||One-sided p-value for treatment difference|Mixed Models Analysis|||||4.56|-1.34|0.1832
70972558|NCT03809611|141451922|SUPERIORITY||Odds Ratio (OR)|1.9||||0.283|TWO_SIDED|90.0|0.72|4.78|||Cochran-Mantel-Haenszel|||||4.78|0.72|0.2830
70972559|NCT02926950|141451924|SUPERIORITY||Difference in Least Squares (LS) Means|-0.47|STANDARD_ERROR_OF_MEAN|0.084|<|0.0001|TWO_SIDED|95.0|-0.64|-0.309|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||-0.309|-0.64|< 0.0001
71094209|NCT04919161|141696423|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||<0.0001
71094210|NCT04919161|141696423|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||<0.0001
71094211|NCT04919161|141696423|SUPERIORITY||||||>|0.9999||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||>0.9999
71094212|NCT04919161|141696423|SUPERIORITY||||||>|0.9999||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||>0.9999
71094213|NCT04919161|141696424|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Kruskal-Wallis|Due to missing measurements and the pairwise nature of the pre- and post-scores, a Kruskal Wallis test was completed.||Null hypothesis is that there are no differences between groups. Prior to hypothesis testing, datasets were tested for normality using a Shapiro-Wilk test to inform if parametric or non-parametric testing was required.||||<0.0001
71094214|NCT04919161|141696424|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Dunn's Multiple Comparison Test|||||||<0.0001
71094215|NCT04919161|141696424|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Dunn's Multiple Comparison Test|||||||<0.0001
70919594|NCT03779048|141330047|OTHER|Correlation to Implicit wanting of Low Fat Savory.|r|-0.03||||0.72|TWO_SIDED||||||Regression, Linear|||Correlation between baseline implicit wanting and 4-week percent weight loss. Because categories are scored relative to each other they cannot be included taughter in the same analysis, so separate correlations were conducted.||||.72
71094216|NCT04919161|141696424|SUPERIORITY||||||>|0.9999||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Dunn's Multiple Comparison Test|||||||>0.9999
71154055|NCT03570749|141800535|SUPERIORITY||Odds Ratio (OR)|3.92|||<|0.001|TWO_SIDED|95.0|1.81|8.51|||Regression, Logistic|||||8.51|1.81|<0.001
70919595|NCT03779048|141330047|OTHER|Correlation to Implicit wanting of High Fat Sweet.|r|0.01||||0.94|TWO_SIDED||||||Regression, Linear|||Correlation between baseline implicit wanting and 4-week percent weight loss. Because categories are scored relative to each other they cannot be included together in the same analysis, so separate correlations were conducted.||||.94
70919596|NCT03779048|141330047|OTHER|Correlation to Implicit wanting of Low Fat Sweet.|r|-0.15||||0.09|TWO_SIDED||||||Regression, Linear|||Correlation between baseline implicit wanting and 4-week percent weight loss. Because categories are scored relative to each other they cannot be included together in the same analysis, so separate correlations were conducted.||||.09
70919597|NCT03779048|141330048|OTHER|Correlation between baseline fasting active ghrelin and 4-week percent weight loss.|r|0.03||||0.73|TWO_SIDED||||||Regression, Linear|||||||.73
70919598|NCT03779048|141330049|OTHER||r|-0.1||||0.25|TWO_SIDED||||||Regression, Linear|||Correlation between baseline fasting leptin and 4-week percent weight loss.||||.25
70919599|NCT03779048|141330050|OTHER|Correlation between baseline postprandial AUC for change in insulin and 4-week percent weight loss.|r|-0.03||||0.72|TWO_SIDED||||||Regression, Linear|||||||.72
70919600|NCT03779048|141330051|OTHER|Correlation between baseline postprandial incremental AUC for PYY and 4-week percent weight loss.|r|-0.02||||0.82|TWO_SIDED||||||Regression, Linear|||||||.82
70972560|NCT02926950|141451925|SUPERIORITY||Difference in LS Means|-1.572|STANDARD_ERROR_OF_MEAN|0.2457|<|0.0001|TWO_SIDED|95.0|-2.0538|-1.0909|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and country as fixed effects, and baseline 2- hour postprandial glucose as a covariate.||-1.0909|-2.0538|< 0.0001
71094217|NCT04919161|141696424|SUPERIORITY||||||>|0.9999||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Dunn's Multiple Comparison Test|||||||>0.9999
71154056|NCT03570749|141800535|SUPERIORITY||Odds Ratio (OR)|10.26|||<|0.001|TWO_SIDED|95.0|5.05|20.87|||Regression, Logistic|||||20.87|5.05|<0.001
71154057|NCT03570749|141800536|SUPERIORITY||Odds Ratio (OR)|5.58||||0.001|TWO_SIDED|95.0|1.97|15.83|||Regression, Logistic|||||15.83|1.97|0.001
71154058|NCT03570749|141800536|SUPERIORITY||Odds Ratio (OR)|14.34|||<|0.001|TWO_SIDED|95.0|5.3|38.83|||Regression, Logistic|||||38.83|5.30|<0.001
71154059|NCT03570749|141800537|SUPERIORITY||Odds Ratio (OR)|10.34|||<|0.001|TWO_SIDED|95.0|2.72|39.3|||Regression, Logistic|||||39.30|2.72|<0.001
71154060|NCT03570749|141800537|SUPERIORITY||Odds Ratio (OR)|18.47|||<|0.001|TWO_SIDED|95.0|5.04|67.68|||Regression, Logistic|||||67.68|5.04|<0.001
71154061|NCT03570749|141800538|SUPERIORITY||Odds Ratio (OR)|6.6|||<|0.001|TWO_SIDED|95.0|2.34|18.62|||Regression, Logistic|||||18.62|2.34|<0.001
70919601|NCT03779048|141330052|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.002|TWO_SIDED|95.0|1.1|5.0|||Mixed Models Analysis|||||5.0|1.1|.002
70919602|NCT03779048|141330057|SUPERIORITY|Difference between placebo- and phentermine-treated participants in change in delay discounting area under the curve from randomization to week 24 was calculated using repeated measures ANCOVA, controlling for age.|F|0.17||||0.68|TWO_SIDED||||||ANCOVA|||||||.68
70919603|NCT03779048|141330058|OTHER|Regression using the three Eating Inventory subscales (Cognitive restraint, disinhibition, hunger) to predict 4-week weight loss|r2|0.01||||0.75|TWO_SIDED|||||For full model including all 3 predictors|Regression, Linear|||||||.75
70919604|NCT03779048|141330059|OTHER|Correlation between baseline past-week appetite and 4-week percent weight loss.|r|-0.09||||0.31|TWO_SIDED||||||Regression, Linear|||||||.31
70919605|NCT03779048|141330061|OTHER|Regression using baseline scores for Behavioral Inhibition (BIS) and Behavioral Activation fro Reward to predict 4-week weight loss during the behavioral treatment run-in.|r2|0.05||||0.03|TWO_SIDED||||||Regression, Linear|||||||.03
70919606|NCT03779048|141330062|OTHER|Correlation between baseline BIS-15 total score and 4-week percent weight loss.|r|0.03||||0.76|TWO_SIDED||||||Regression, Linear|||||||.76
71154062|NCT03570749|141800538|SUPERIORITY||Odds Ratio (OR)|13.58|||<|0.001|TWO_SIDED|95.0|5.01|36.81|||Regression, Logistic|||||36.81|5.01|<0.001
70919607|NCT03422276|141330085|SUPERIORITY||Mean Difference (Net)|-0.78||||0.44|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|t-test, 2 sided|t-test for independent samples, two-tailed, allocation ratio=1|Intervention mean minus control mean|It was calculated that 500 to 900 participants randomized in a 1:1 fashion between the two arms would have practically 100% power to detect an effect size of 0.5, and even a small sample size of 300 would have 80% power to detect a small effect size of 0.3 (800 to 900 would be 100% power).||||0.44
70919608|NCT03422276|141330086|SUPERIORITY||Mean Difference (Net)|1.63||||0.1|TWO_SIDED||||||t-test, 2 sided|||||||0.10
70919609|NCT04588259|141330119|NON_INFERIORITY|The upper limit of the 95% confidence interval (CI) for the difference between faster aspart and NovoRapid was compared to a non-inferiority margin of 0.4%. If it was below or equal to 0.4%, non-inferiority was considered to be established and effect demonstrated.|Treatment difference|-0.05||||0.5102|TWO_SIDED|95.0|-0.19|0.09||p-values are from the 2-sided test for treatment difference evaluated at the 5% level.|Mixed Models Analysis|||The outcome measure was analysed using mixed-effect model for repeated measurement (MMRM) where all calculated changes in HbA1c from baseline at visits were included in analysis. Model included treatment and stratification of type 1 diabetes mellitus/ type 2 diabetes mellitus (T1DM/T2DM) as fixed factors, HbA1c at baseline as covariate and interactions between all fixed factors and visit. An unstructured covariance matrix described the variability for the repeated measurements for a participant.||0.09|-0.19|0.5102
70919610|NCT04588259|141330120|NON_INFERIORITY|The upper limit of the 95% CI for the difference between faster aspart and NovoRapid was compared to a non-inferiority margin of 0.4%. If it was below or equal to 0.4%, non-inferiority was considered to be established and effect demonstrated.|Treatment Difference|-0.52||||0.5102|TWO_SIDED|95.0|-2.08|1.03||p-values are from the 2-sided test for treatment difference evaluated at the 5% level.|Mixed Models Analysis|||The outcome measure was analysed using a mixed-effect model for repeated measurements (MMRM) where all calculated changes in HbA1c from baseline at visits are included in the analysis. The model includes treatment and stratification (T1DM/T2DM) as fixed factors, HbA1c at baseline as covariate and interactions between all fixed factors and visit. An unstructured covariance matrix is used to describe the variability for the repeated measurements for a participant.||1.03|-2.08|0.5102
70919611|NCT01164098|141330148|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|Using Natural Log Transformed Data||T-test of the natural logarithmic transformed data||||0.18
70919612|NCT01164098|141330149|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||T-test of Natural Log Transformed Data.||||0.49
70919613|NCT01164098|141330150|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||T-test||||0.37
70919614|NCT03074331|141330183|SUPERIORITY|||||||0.009|||||||2-sided exact 1-sample binomial test|||The SVR12 rate was compared to the pre-specified performance goal of 85% by using a two-sided exact one-sample binomial test at the 0.05 significance level.||||0.009
70919615|NCT01546753|141330186|SUPERIORITY|The change from baseline OFC to week 38 OFC (primary outcome measure) was compared between the two groups using a Mann-Whitney U test.||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
70919616|NCT01546753|141330187|SUPERIORITY|Differences in dichotomous outcomes for the percentage of participants who reach the 5000 mg cumulative dose to the walnut at the week 38 desensitization OFC was analyzed using Fisher's exact test||||||0.01|||||||Fisher Exact|||||||0.01
70919617|NCT01546753|141330188|SUPERIORITY|Differences in dichotomous outcomes including the percentage of subjects who reach the 2000 mg cumulative dose to the walnut at the week 38 desensitization OFC was analyzed using Fisher's exact test|||||<|0.01|||||||Fisher Exact|||||||<0.01
70919618|NCT01546753|141330189|SUPERIORITY|Differences in dichotomous outcomes such as the percentage of subjects who reach the 2000 mg cumulative dose to the tree nut at the week 38 desensitization OFC was analyzed using Fisher's exact test|||||<|0.01|||||||Fisher Exact|||||||<0.01
70919619|NCT01546753|141330191|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
70919620|NCT01796236|141330193|SUPERIORITY_OR_OTHER|||||||0.12|||||||Mantel Haenszel|||||||0.12
70919621|NCT01796236|141330194|SUPERIORITY_OR_OTHER|||||||0.45|||||||Mantel Haenszel|||"Combined Endpoint is calculated as the sum of the following four events from 3 weeks to 3 years:~Holgers Index \>=2. Any Overgrowth \>=2. Pain (scar/neuropathic) \>=3. Any numbness \>=2.~Each event is counted only once"||||0.45
70919622|NCT01796236|141330195|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mann-Whitney U test|||||||<0.0001
70919623|NCT01796236|141330196|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Fisher Exact|||Day 10||||0.020
70919624|NCT01796236|141330196|SUPERIORITY_OR_OTHER|||||||0.4|||||||Fisher Exact|||Week 3||||0.4
70919625|NCT01796236|141330196|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Week 6||||1.00
70919626|NCT01796236|141330196|SUPERIORITY_OR_OTHER|||||||0.97|||||||Fisher Exact|||Week 12||||0.97
70919627|NCT01796236|141330196|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Week 24||||1.00
70919628|NCT01796236|141330197|SUPERIORITY_OR_OTHER|||||||0.4|||||||Mantel Haenszel|||Maximum of Holgers at 12 Months||||0.40
70919629|NCT01796236|141330197|SUPERIORITY_OR_OTHER|||||||0.14|||||||Mantel Haenszel|||Maximum of Holgers at 36 Months||||0.14
70919630|NCT01796236|141330198|SUPERIORITY_OR_OTHER|||||||0.38|||||||Mantel Haenszel|||Holgers Index Day 10||||0.38
70919631|NCT01796236|141330198|SUPERIORITY_OR_OTHER|||||||0.17|||||||Mantel Haenszel|||Holgers Index Week 3||||0.17
70919632|NCT01796236|141330198|SUPERIORITY_OR_OTHER|||||||0.37|||||||Mantel Haenszel|||Holgers Index Week 6||||0.37
70919633|NCT01796236|141330198|SUPERIORITY_OR_OTHER|||||||0.73|||||||Mantel Haenszel|||Holgers Index Week 12||||0.73
70919634|NCT01796236|141330198|SUPERIORITY_OR_OTHER|||||||0.47|||||||Mantel Haenszel|||Holgers Index Week 24||||0.47
70919635|NCT01796236|141330198|SUPERIORITY_OR_OTHER|||||||0.73|||||||Mantel Haenszel|||Holgers Index Month 12||||0.73
70919636|NCT01796236|141330198|SUPERIORITY_OR_OTHER|||||||0.37|||||||Mantel Haenszel|||Holgers Index Month 24||||0.37
70919637|NCT01796236|141330198|SUPERIORITY_OR_OTHER|||||||0.75|||||||Mantel Haenszel|||Holgers Index Month 36||||0.75
70919638|NCT01796236|141330199|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mantel Haenszel|||maximum numbness at 12 months||||<0.0001
70919639|NCT01796236|141330199|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mantel Haenszel|||maximum numbness at 36 months||||<0.0001
71154063|NCT03570749|141800539|SUPERIORITY||Odds Ratio (OR)|4.63||||0.012|TWO_SIDED|95.0|1.41|15.27|||Regression, Logistic|||||15.27|1.41|0.012
70919640|NCT01796236|141330200|SUPERIORITY_OR_OTHER|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Day 10, Neuropathic pain||||0.74
70919641|NCT01796236|141330200|SUPERIORITY_OR_OTHER|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||Day 10, Scar pain||||0.36
70919642|NCT01796236|141330200|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Week 3, Neuropathic pain||||0.030
70919643|NCT01796236|141330200|SUPERIORITY_OR_OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||Week 3, Scar pain||||0.92
70919644|NCT01796236|141330200|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Week 6, Neuropathic pain||||0.15
70919645|NCT01796236|141330200|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Week 6, Scar pain||||0.38
70919646|NCT01796236|141330200|SUPERIORITY_OR_OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||Week 12, Neuropathic pain||||0.015
70972561|NCT02926950|141451926|SUPERIORITY||Difference in LS Means|-0.76|STANDARD_ERROR_OF_MEAN|0.2247|=|0.0007|TWO_SIDED|95.0|-1.2006|-0.3198|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline fasting plasma glucose as a covariate.||-0.3198|-1.2006|= 0.0007
70972562|NCT02926950|141451927|SUPERIORITY||Difference in LS Means|-1.87|STANDARD_ERROR_OF_MEAN|0.369|<|0.0001|TWO_SIDED|95.0|-2.591|-1.144|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and country as fixed effects, and baseline weight as a covariate.||-1.144|-2.591|< 0.0001
70972563|NCT02926950|141451928|SUPERIORITY||Difference in LS Means|-3.28|STANDARD_ERROR_OF_MEAN|1.422|=|0.0209|TWO_SIDED|95.0|-6.07|-0.497|||ANCOVA|||The change from baseline to Week 12 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤ 8.0, \>8.0%) at screening, and country as fixed effects, and baseline SBP as a covariate.||-0.497|-6.07|= 0.0209
70972564|NCT02926950|141451929|SUPERIORITY||Difference in LS Means|-3.54|STANDARD_ERROR_OF_MEAN|0.992|=|0.0004|TWO_SIDED|95.0|-5.479|-1.592|||ANCOVA|||The change from baseline to Week 12 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤ 8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline SBP as a covariate.||-1.592|-5.479|= 0.0004
70972565|NCT02926950|141451930|SUPERIORITY||Percentage Difference|5.4|||=|0.0238|TWO_SIDED|95.0|0.75|10.06|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening. Missing data at Week 26 were assigned a status of nonresponder in the analysis.||10.06|0.75|= 0.0238
70919647|NCT01796236|141330200|SUPERIORITY_OR_OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Week 12, Scar pain||||0.72
70919648|NCT01796236|141330200|SUPERIORITY_OR_OTHER|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Week 24, Neuropathic pain||||0.44
70919649|NCT01796236|141330200|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||Week 24, Scar pain||||0.43
70919650|NCT01796236|141330200|SUPERIORITY_OR_OTHER|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Month 12, Neuropathic pain||||0.21
70919651|NCT01796236|141330200|SUPERIORITY_OR_OTHER|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||Month 12, Scar pain||||0.97
70919652|NCT01796236|141330200|SUPERIORITY_OR_OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Month 36, Neuropathic pain||||0.19
70919653|NCT01796236|141330200|SUPERIORITY_OR_OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||Month 36, Scar pain||||0.77
70919654|NCT01796236|141330201|SUPERIORITY_OR_OTHER|||||||0.076|||||||Mantel Haenszel|||Neuropathic Categorical Max Pain||||0.076
70919655|NCT01796236|141330201|SUPERIORITY_OR_OTHER|||||||0.49|||||||Mantel Haenszel|||Scar Categorical Max Pain||||0.49
70919656|NCT01796236|141330202|SUPERIORITY_OR_OTHER|||||||0.076|||||||Mantel Haenszel|||Neuropathic Categorical Max Pain 36 months||||0.076
70919657|NCT01796236|141330202|SUPERIORITY_OR_OTHER|||||||0.71|||||||Mantel Haenszel|||Scar Categorical Max Pain 36 months||||0.71
70919658|NCT01796236|141330203|SUPERIORITY_OR_OTHER|||||||0.52|||||||Cochran-Mantel-Haenszel|||Day 10: Neuropathic pain||||0.52
70919659|NCT01796236|141330203|SUPERIORITY_OR_OTHER|||||||0.44|||||||Cochran-Mantel-Haenszel|||Day 10: Scar pain||||0.44
70919660|NCT01796236|141330203|SUPERIORITY_OR_OTHER|||||||0.14|||||||Cochran-Mantel-Haenszel|||Week 3: Neuropathic pain||||0.14
70919661|NCT01796236|141330203|SUPERIORITY_OR_OTHER|||||||0.59|||||||Cochran-Mantel-Haenszel|||Week 3: Scar pain||||0.59
70919662|NCT01796236|141330203|SUPERIORITY_OR_OTHER|||||||0.17|||||||Cochran-Mantel-Haenszel|||Week 6: Neuropathic pain||||0.17
70919663|NCT01796236|141330203|SUPERIORITY_OR_OTHER|||||||0.44|||||||Cochran-Mantel-Haenszel|||Week 6: Scar pain||||0.44
70919664|NCT01796236|141330203|SUPERIORITY_OR_OTHER|||||||0.0087|||||||Cochran-Mantel-Haenszel|||Week 12: Neuropathic pain||||0.0087
70919665|NCT01796236|141330203|SUPERIORITY_OR_OTHER|||||||0.84|||||||Cochran-Mantel-Haenszel|||Week 12: Scar pain||||0.84
70919666|NCT01796236|141330203|SUPERIORITY_OR_OTHER|||||||0.43|||||||Cochran-Mantel-Haenszel|||Week 24: Neuropathic pain||||0.43
70919667|NCT01796236|141330203|SUPERIORITY_OR_OTHER|||||||0.33|||||||Cochran-Mantel-Haenszel|||Week 24: Scar pain||||0.33
70919668|NCT01796236|141330203|SUPERIORITY_OR_OTHER|||||||0.21|||||||Cochran-Mantel-Haenszel|||Month 12 Neuropathic pain||||0.21
70919669|NCT01796236|141330203|SUPERIORITY_OR_OTHER|||||||0.82|||||||Cochran-Mantel-Haenszel|||Month 12 Scar pain||||0.82
70919670|NCT01796236|141330203|SUPERIORITY_OR_OTHER|||||||0.19|||||||Cochran-Mantel-Haenszel|||Month 36 Neuropathic pain||||0.19
70919671|NCT01796236|141330203|SUPERIORITY_OR_OTHER|||||||0.77|||||||Cochran-Mantel-Haenszel|||Month 36 Scar pain||||0.77
70919672|NCT01796236|141330204|SUPERIORITY_OR_OTHER|||||||0.12|||||||Mantel Haenszel|||Day 10 Soft tissue thickening/overgrowth||||0.12
70919673|NCT01796236|141330204|SUPERIORITY_OR_OTHER|||||||0.016|||||||Mantel Haenszel|||Week 3 Soft tissue thickening/overgrowth||||0.016
70919674|NCT01796236|141330204|SUPERIORITY_OR_OTHER|||||||0.84|||||||Mantel Haenszel|||Week 6 Soft tissue thickening/overgrowth||||0.84
70919675|NCT01796236|141330204|SUPERIORITY_OR_OTHER|||||||0.53|||||||Mantel Haenszel|||Week 12 Soft tissue thickening/overgrowth||||0.53
70919676|NCT01796236|141330204|SUPERIORITY_OR_OTHER|||||||0.18|||||||Mantel Haenszel|||Week 24 Soft tissue thickening/overgrowth||||0.18
70919677|NCT01796236|141330204|SUPERIORITY_OR_OTHER|||||||0.63|||||||Mantel Haenszel|||Month 12 Soft tissue thickening/overgrowth||||0.63
71094218|NCT04919161|141696425|SUPERIORITY||||||<|0.0001||||||The threshold for statistical significance was p\<0.05.|Kruskal-Wallis|Due to the missing measurement and the pairwise nature of the perturbation levels between participants, a Kruskal Wallis test was completed.||Null hypothesis is there are no differences between groups. Prior to hypothesis testing, normality testing was conducted using a Shapiro-Wild test to inform if parametric or non-parametric testing was required.||||<0.0001
71094219|NCT04919161|141696425|SUPERIORITY||||||>|0.9999||||||Reported p-value is adjusted for multiple comparisons. The a priori threshold for statistical significance was established as p\<0.05.|Dunn's Multiple Comparison Test|||Null hypothesis for any comparisons would be that there is no significant mean perturbation level between sessions.|The p-value reported above was the result for 15 comparisons of the recorded perturbation levels in sessions: 1 vs 2, 2 vs 3, 3 vs 4, 3 vs 5, 3 vs 6, 4 vs 5, 4 vs 6, 4 vs 7, 4 vs 8, 5 vs 6, 5 vs 7, 5 vs 8, 6 vs 7, 6 vs 8, and 7 vs 8.|||>0.9999
71094220|NCT04919161|141696425|SUPERIORITY||||||=|0.0629|||||||Dunn's Multiple Comparison Test|||||||=0.0629
71094221|NCT04919161|141696425|SUPERIORITY||||||=|0.0069|||||||Dunn's Multiple Comparison Test|||||||=0.0069
70972566|NCT02926950|141451931|SUPERIORITY||Percentage Difference|13.9|||=|0.0001|TWO_SIDED|95.0|6.91|20.89|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening. Missing data at Week 26 were assigned a status of nonresponder in the analysis.||20.89|6.91|= 0.0001
70919678|NCT01796236|141330204|SUPERIORITY_OR_OTHER|||||||0.81|||||||Mantel Haenszel|||Month 24 Soft tissue thickening/overgrowth||||0.81
70919679|NCT01796236|141330204|SUPERIORITY_OR_OTHER|||||||1|||||||Mantel Haenszel|||Month 36 Soft tissue thickening/overgrowth||||1.00
70919680|NCT01796236|141330205|SUPERIORITY_OR_OTHER|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Day 10||||0.0009
70919681|NCT01796236|141330205|SUPERIORITY_OR_OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Week 3||||0.0080
70919682|NCT01796236|141330205|SUPERIORITY_OR_OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Week 6||||0.46
70919683|NCT01796236|141330205|SUPERIORITY_OR_OTHER|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Week 12||||0.45
70919684|NCT01796236|141330205|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Week 24||||0.18
70972567|NCT01535729|141451950|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.949|STANDARD_ERROR_OF_MEAN|0.167||0.756|TWO_SIDED|95.0|0.684|1.318|||Wald Chi-Squares|||Comparison between 70-74 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.||1.318|0.684|0.756
71094222|NCT04919161|141696425|SUPERIORITY||||||=|0.0003|||||||Dunn's Multiple Comparison Test|||||||=0.0003
71094223|NCT04919161|141696425|SUPERIORITY||||||<|0.0001|||||||Dunn's Multiple Comparison Test|||||||<0.0001
71094224|NCT04919161|141696425|SUPERIORITY||||||<|0.0001|||||||Dunn's Multiple Comparison Test|||||||<0.0001
70919685|NCT01796236|141330205|SUPERIORITY_OR_OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Month 12||||0.017
70919686|NCT01796236|141330205|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Month 24||||0.15
71094225|NCT04919161|141696425|SUPERIORITY||||||<|0.0001|||||||Dunn's Multiple Comparison Test|||||||<0.0001
70919687|NCT01796236|141330205|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Month 36||||0.32
70919688|NCT01796236|141330205|SUPERIORITY_OR_OTHER|||||||0.74|||||||Sign test|||Change in Visible Test Abutment - Week 3 change from day 10||||0.74
70919689|NCT01796236|141330205|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Visible Test Abutment - Week 6 change from day 10||||<0.0001
70919690|NCT01796236|141330205|SUPERIORITY_OR_OTHER|||||||0.041|||||||Sign test|||Change in Visible Test Abutment - Week 12 change from day 10||||0.041
70919691|NCT01796236|141330205|SUPERIORITY_OR_OTHER|||||||0.0065|||||||Sign test|||Change in Visible Test Abutment - Week 24 change from day 10||||0.0065
70919692|NCT01796236|141330205|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Sign test|||Change in Visible Test Abutment - Month 12 change from day 10||||0.0003
70919693|NCT01796236|141330205|SUPERIORITY_OR_OTHER|||||||0.028|||||||Sign test|||Change in Visible Test Abutment - Month 24 change from day 10||||0.028
70919694|NCT01796236|141330205|SUPERIORITY_OR_OTHER|||||||0.037|||||||Sign test|||Change in Visible Test Abutment - Month 36 change from day 10||||0.037
70919695|NCT01796236|141330205|SUPERIORITY_OR_OTHER|||||||0.072|||||||Sign test|||Change in Visible Control Abutment - Week 3 change from day 10||||0.072
70919696|NCT01796236|141330205|SUPERIORITY_OR_OTHER|||||||0.034|||||||Sign test|||Change in Visible Control Abutment - Week 6 change from day 10||||0.034
70919697|NCT01796236|141330205|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Visible Control Abutment - Week 12 change from day 10||||<0.0001
70919698|NCT01796236|141330205|SUPERIORITY_OR_OTHER|||||||0.01|||||||Sign test|||Change in Visible Control Abutment - Week 24 change from day 10||||0.010
70919699|NCT01796236|141330205|SUPERIORITY_OR_OTHER|||||||0.0086|||||||Sign test|||Change in Visible Control Abutment - Month 12 change from day 10||||0.0086
70919700|NCT01796236|141330205|SUPERIORITY_OR_OTHER|||||||0.0021|||||||Sign test|||Change in Visible Control Abutment - Month 24 change from day 10||||0.0021
70919701|NCT01796236|141330205|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Sign test|||Change in Visible Control Abutment - Month 36 change from day 10||||0.0005
71094226|NCT04919161|141696425|SUPERIORITY||||||=|0.6497|||||||Dunn's Multiple Comparison Test|||||||=0.6497
71094227|NCT04919161|141696425|SUPERIORITY||||||=|0.0743|||||||Dunn's Multiple Comparison Test|||||||=0.0743
71094228|NCT04919161|141696425|SUPERIORITY||||||=|0.0198|||||||Dunn's Multiple Comparison Test|||||||=0.0198
71094229|NCT04919161|141696425|SUPERIORITY||||||=|0.0017|||||||Dunn's Multiple Comparison Test|||||||=0.0017
71094230|NCT04919161|141696425|SUPERIORITY||||||=|0.0006|||||||Dunn's Multiple Comparison Test|||||||=0.0006
71094231|NCT04919161|141696425|SUPERIORITY||||||=|0.5297|||||||Dunn's Multiple Comparison Test|||||||=0.5297
71094232|NCT04919161|141696425|SUPERIORITY||||||=|0.2595|||||||Dunn's Multiple Comparison Test|||||||=0.2595
71094233|NCT04919161|141696426|OTHER|This is a descriptive analysis.|Odds Ratio (OR)|2.6|||=|0.3898|TWO_SIDED|95.0|0.4671|15.3||Threshold for statistical significance was p\<0.05|Fisher Exact|||Null hypothesis was that there would be no difference in the proportion of males and females between treatment arms.||15.300|0.4671|=0.3898
71094234|NCT00712920|141696427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.03||95.0|-1.7|-0.1|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.10|-1.70|0.03
71094235|NCT00712920|141696427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.08||95.0|-1.5|0.1|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||0.1|-1.5|0.08
71094236|NCT00712920|141696428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6419|STANDARD_DEVIATION|0.3924||0.102||95.0|-1.41|0.13|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||0.13|-1.41|0.102
71094237|NCT00712920|141696428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7925|STANDARD_DEVIATION|0.3935||0.044||95.0|-1.56|-0.02|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.02|-1.56|0.044
71094238|NCT00712920|141696429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4394|STANDARD_DEVIATION|0.3631||0.226||95.0|-1.15|0.27|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 28||0.27|-1.15|0.226
71094239|NCT00712920|141696429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1252|STANDARD_DEVIATION|0.3649||0.002||95.0|-1.84|-0.41|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 28||-0.41|-1.84|0.002
71094240|NCT00712920|141696430|SUPERIORITY_OR_OTHER|||||||0.292||95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||||||0.292
71094241|NCT00712920|141696430|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||||||0.040
71094242|NCT02489773|141696432|OTHER|Calculate the pearson correlation within whole subjects (across Group 1 and Group 2)|pearson correlation coefficient|0.6342|||||TWO_SIDED|||||||||||||
71094243|NCT02489773|141696432|OTHER|Diffenrence between Pearson correlations within whole subjects (accross Group 1 and Group 2) and PG, 0.8.|Difference with PG 0.8|-0.1658|||>|0.9999|TWO_SIDED|95.0|-0.2204|-0.1113|||t-test, 2 sided|||||-0.1113|-0.2204|>0.9999
70919702|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.026|||||||Wilcoxon (Mann-Whitney)|||Week 12: Vascularity (observer)||||0.026
70972568|NCT01535729|141451950|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.744|STANDARD_ERROR_OF_MEAN|0.185||0.11|TWO_SIDED|95.0|0.518|1.07|||Wald Chi-Squares|||Comparison between 75-79 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.||1.070|0.518|0.110
70972569|NCT01535729|141451950|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.054|STANDARD_ERROR_OF_MEAN|0.242||0.829|TWO_SIDED|95.0|0.656|1.692|||Wald Chi-Squares|||Comparison between ≥ 80 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.||1.692|0.656|0.829
70919703|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||Month 12: Vascularity (observer)||||0.33
71094244|NCT02489773|141696433|OTHER|The difference in Spearman correlation coefficient between GA and MBG vs HbA1c and MBG in the first 3-month period in Group 1.|Difference in correlation coefficients|0.249|||<|0.0001|TWO_SIDED|95.0|0.13|0.364|||t-test, 2 sided|||||0.364|0.130|<0.0001
71094245|NCT02489773|141696434|OTHER|The difference in Kendall correlation coefficient between GA and MBG vs HbA1c and MBG in the first 3-month period in Group 1.|Difference in correlation coefficient|0.181|||<|0.0001|TWO_SIDED|95.0|0.096|0.265|||t-test, 2 sided|||||0.265|0.096|<0.0001
71094246|NCT02493855|141696447|SUPERIORITY|This study was an exploratory study to evaluate the effect of ribavirin on the slope of the second phase of HCV RNA decline in participants who received the 3-direct-acting antiviral agent regimen.||||||0.311|||||||Wilcoxon Rank Sum Test|||||||0.311
71094247|NCT02493855|141696447|SUPERIORITY|This study was an exploratory study to evaluate the effect of ribavirin on the slope of the second phase of HCV RNA decline in participants who received the 3-direct-acting antiviral agent regimen.||||||0.561|||||||Wilcoxon Rank Sum Test|||||||0.561
71094248|NCT01482221|141696451|SUPERIORITY_OR_OTHER||LS mean difference|-1.18|STANDARD_ERROR_OF_MEAN|1.695||0.63|TWO_SIDED|95.0|-4.519|2.152||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Mixed models for repeated measures|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, and baseline MADRS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline MADRS score by visit interaction are fixed effects in the model; pooled center is a random effect.||2.152|-4.519|0.630
71094249|NCT01482221|141696451|SUPERIORITY_OR_OTHER||LS mean difference|-1.21|STANDARD_ERROR_OF_MEAN|1.701||0.476|TWO_SIDED|95.0|-4.563|2.134||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline MADRS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline MADRS score by visit interaction are fixed effects in the model; pooled center is a random effect.||2.134|-4.563|0.476
71154064|NCT03570749|141800539|SUPERIORITY||Odds Ratio (OR)|14.42|||<|0.001|TWO_SIDED|95.0|4.73|43.93|||Regression, Logistic|||||43.93|4.73|<0.001
71154065|NCT03570749|141800540|SUPERIORITY||Mean Difference (Final Values)|-23.1|STANDARD_ERROR_OF_MEAN|3.806|<|0.001|TWO_SIDED|95.0|-30.57|-15.63|||ANCOVA|||||-15.63|-30.57|<0.001
71154066|NCT03570749|141800540|SUPERIORITY||Mean Difference (Final Values)|-37.65|STANDARD_ERROR_OF_MEAN|3.447|<|0.001|TWO_SIDED|95.0|-44.24|-30.89|||ANCOVA|||||-30.89|-44.24|<0.001
70919704|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.094|||||||Wilcoxon (Mann-Whitney)|||Month 36: Vascularity (observer)||||0.094
70919705|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Week 12: Pigmentation (observer)||||0.30
70919706|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Month 12: Pigmentation (observer)||||0.23
70919707|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Month 36: Pigmentation (observer)||||0.48
71094250|NCT01482221|141696452|SUPERIORITY_OR_OTHER||LS mean difference|-2.05|STANDARD_ERROR_OF_MEAN|1.816||0.63|TWO_SIDED|95.0|-5.628|1.522||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Mixed models for repeated measures|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, and baseline MADRS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline MADRS score by visit interaction are fixed effects in the model; pooled center is a random effect.||1.522|-5.628|0.630
71094251|NCT01482221|141696452|SUPERIORITY_OR_OTHER||LS mean difference|0.88|STANDARD_ERROR_OF_MEAN|1.83||0.63|TWO_SIDED|95.0|-2.72|4.485||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline MADRS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline MADRS score by visit interaction are fixed effects in the model; pooled center is a random effect.||4.485|-2.720|0.630
71094252|NCT01482221|141696453|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07|STANDARD_ERROR_OF_MEAN|0.366||0.852|TWO_SIDED|95.0|0.544|2.089||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Regression, Logistic|||Logistic regression model including treatment as a fixed effect and the baseline MADRS total score as a covariate.||2.089|0.544|0.852
71094253|NCT01482221|141696453|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08|STANDARD_ERROR_OF_MEAN|0.37||0.821|TWO_SIDED|95.0|0.552|2.115||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Regression, Logistic|||Logistic regression model including treatment as a fixed effect and the baseline MADRS total score as a covariate.||2.115|0.552|0.821
71094254|NCT01482221|141696454|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.318||0.751|TWO_SIDED|95.0|0.485|1.686|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||1.686|0.485|0.751
71094255|NCT01482221|141696454|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|STANDARD_ERROR_OF_MEAN|0.315||0.555|TWO_SIDED|95.0|0.65|2.233|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||2.233|0.650|0.555
71094256|NCT01482221|141696455|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27|STANDARD_ERROR_OF_MEAN|0.304||0.434|TWO_SIDED|95.0|0.699|2.301|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||2.301|0.699|0.434
71094257|NCT01482221|141696455|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71|STANDARD_ERROR_OF_MEAN|0.322||0.286|TWO_SIDED|95.0|0.377|1.334|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||1.334|0.377|0.286
71094258|NCT01482221|141696456|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42|STANDARD_ERROR_OF_MEAN|0.382||0.357|TWO_SIDED|95.0|0.672|3.007|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||3.007|0.672|0.357
71094259|NCT01482221|141696456|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33|STANDARD_ERROR_OF_MEAN|0.387||0.463|TWO_SIDED|95.0|0.622|2.84|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||2.840|0.622|0.463
71094260|NCT01482221|141696457|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04|STANDARD_ERROR_OF_MEAN|0.342||0.911|TWO_SIDED|95.0|0.532|2.031|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||2.031|0.532|0.911
71154067|NCT03570749|141800541|SUPERIORITY||Odds Ratio (OR)|2.31||||0.047|TWO_SIDED|95.0|1.01|5.29|||Regression, Logistic|||||5.29|1.01|0.047
71094261|NCT01482221|141696457|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78|STANDARD_ERROR_OF_MEAN|0.368||0.509|TWO_SIDED|95.0|0.382|1.613|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||1.613|0.382|0.509
71154068|NCT03570749|141800541|SUPERIORITY||Odds Ratio (OR)|6.03|||<|0.001|TWO_SIDED|95.0|2.91|12.51|||Regression, Logistic|||||12.51|2.91|<0.001
71154069|NCT03570749|141800543|SUPERIORITY||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.288||0.005|TWO_SIDED|95.0|-1.38|-0.25|||ANCOVA|||||-0.25|-1.38|0.005
70919708|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||Week 12: Thickness (observer)||||0.0003
70919709|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.062|||||||Wilcoxon (Mann-Whitney)|||Month 12: Thickness (observer)||||0.062
70919710|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Month 36: Thickness (observer)||||0.11
71154070|NCT03570749|141800543|SUPERIORITY||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.261||0.04|TWO_SIDED|95.0|-1.05|-0.02|||ANCOVA|||||-0.02|-1.05|0.040
71154071|NCT03570749|141800544|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.259||0.107|TWO_SIDED|95.0|-0.93|0.09|||ANCOVA|||||0.09|-0.93|0.107
71154072|NCT03570749|141800544|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.234||0.174|TWO_SIDED|95.0|-0.78|0.14|||ANCOVA|||||0.14|-0.78|0.174
70919711|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||Week 12: Relief (observer)||||0.0003
70919712|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.079|||||||Wilcoxon (Mann-Whitney)|||Month 12: Relief (observer)||||0.079
71094262|NCT01482221|141696458|SUPERIORITY_OR_OTHER||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|1.238||0.889|TWO_SIDED|95.0|-2.609|2.264||Analysis for change in SDS total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline SDS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline SDS score by visit interaction are fixed effects in the model; pooled center is a random effect.||2.264|-2.609|0.889
71094263|NCT01482221|141696458|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|1.264||0.992|TWO_SIDED|95.0|-2.477|2.501||Analysis for change in SDS total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline SDS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline SDS score by visit interaction are fixed effects in the model; pooled center is a random effect.||2.501|-2.477|0.992
71094264|NCT01482221|141696458|SUPERIORITY_OR_OTHER||LS mean difference|1.11|STANDARD_ERROR_OF_MEAN|1.301||0.392|TWO_SIDED|95.0|-1.448|3.678||Analysis for change in SDS total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline SDS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline SDS score by visit interaction are fixed effects in the model; pooled center is a random effect.||3.678|-1.448|0.392
71094265|NCT01482221|141696458|SUPERIORITY_OR_OTHER||LS mean difference|1.29|STANDARD_ERROR_OF_MEAN|1.329||0.333|TWO_SIDED|95.0|-1.327|3.908||Analysis for changed in SDS total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline SDS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline SDS score by visit interaction are fixed effects in the model; pooled center is a random effect.||3.908|-1.327|0.333
71094266|NCT01482221|141696459|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.728|TWO_SIDED|95.0|-0.49|0.34||Analysis for change in CGI-S total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction are fixed effects in the model; pooled center is a random effect.||0.34|-0.49|0.728
71094267|NCT01482221|141696459|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.562|TWO_SIDED|95.0|-0.54|0.29||Analysis for change in CGI-S total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction are fixed effects in the model; pooled center is a random effect.||0.29|-0.54|0.562
71094268|NCT01482221|141696459|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.283|TWO_SIDED|95.0|-0.64|0.19||Analysis for change in CGI-S total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction are fixed effects in the model; pooled center is a random effect.||0.19|-0.64|0.283
71154073|NCT01886872|141800605|SUPERIORITY||Hazard Ratio (HR)|0.39|||<|0.001|TWO_SIDED|95.0|0.26|0.58||(1-sided)|Log Rank|||Arm B (Ibrutinib) versus Arm A (Rituximab, Bendamustine Hydrochloride)||0.58|0.26|<0.001
70972570|NCT01535729|141451965|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.981|STANDARD_ERROR_OF_MEAN|0.143||0.895|TWO_SIDED|95.0|0.741|1.299|||Wald Chi-Squares|||Comparison between 70-74 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.||1.299|0.741|0.895
70972571|NCT01535729|141451965|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.689|STANDARD_ERROR_OF_MEAN|0.162||0.022|TWO_SIDED|95.0|0.501|0.947|||Wald Chi-Squares|||Comparison between 75-79 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.||0.947|0.501|0.022
70972572|NCT01535729|141451965|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.162|STANDARD_ERROR_OF_MEAN|0.212||0.479|TWO_SIDED|95.0|0.767|1.759|||Wald Chi-Squares|||Comparison between ≥ 80 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.||1.759|0.767|0.479
70972573|NCT01535729|141451966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.732|STANDARD_ERROR_OF_MEAN|0.129||0.015|TWO_SIDED|95.0|0.569|0.941|||Wald Chi-Squares|||Comparison between female and male was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor gender.||0.941|0.569|0.015
70972574|NCT01535729|141451967|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.902|STANDARD_ERROR_OF_MEAN|0.156||0|TWO_SIDED|95.0|1.402|2.582|||Wald Chi-Squares|||Comparison between ex-smoker and non-smoker was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor smoking.||2.582|1.402|0.000
70972575|NCT01535729|141451967|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.786|STANDARD_ERROR_OF_MEAN|0.183||0.002|TWO_SIDED|95.0|1.248|2.557|||Wald Chi-Squares|||Comparison between smoker and non-smoker was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor smoking.||2.557|1.248|0.002
70972576|NCT01535729|141451970|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.717|STANDARD_ERROR_OF_MEAN|0.15||0.027|TWO_SIDED|95.0|0.535|0.962|||Wald Chi-Squares|||Comparison between female and male was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor gender.||0.962|0.535|0.027
71154074|NCT01886872|141800605|SUPERIORITY||Hazard Ratio (HR)|0.38|||<|0.001|TWO_SIDED|95.0|0.25|0.59||(1-sided)|Log Rank|||Arm C (Ibrutinib, Rituximab) versus Arm A (Rituximab, Bendamustine Hydrochloride)||0.59|0.25|<0.001
71154075|NCT01886872|141800605|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.49|TWO_SIDED|95.0|0.62|1.62||(1-sided)|Log Rank|||Arm C (Ibrutinib, Rituximab) versus Arm B (Ibrutinib)||1.62|0.62|0.49
71094269|NCT01482221|141696459|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.21||0.54|TWO_SIDED|95.0|-0.29|0.55||Analysis for changed in CGI-S total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction are fixed effects in the model; pooled center is a random effect.||0.55|-0.29|0.540
70972577|NCT01535729|141451971|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.935|STANDARD_ERROR_OF_MEAN|0.179||0|TWO_SIDED|95.0|1.362|2.749|||Wald Chi-Squares|||Comparison between ex-smoker and non-smoker was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor smoking.||2.749|1.362|0.000
70972578|NCT01535729|141451971|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.882|STANDARD_ERROR_OF_MEAN|0.213||0.003|TWO_SIDED|95.0|1.239|2.859|||Wald Chi-Squares|||Comparison between smoker and non-smoker was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor smoking.||2.859|1.239|0.003
70972579|NCT01262365|141451973|SUPERIORITY||Odds Ratio (OR)|1.307|||=|0.175|TWO_SIDED|95.0|0.888|1.923|||Regression, Logistic|p-values have been calculated using logistic regression with factors for treatment, region, and baseline disease status.||Odds Ratio: Epratuzumab/Placebo calculated using logistic regression with factors for treatment, region, and baseline disease status.||1.923|0.888|=0.175
70972580|NCT01262365|141451973|SUPERIORITY||Odds Ratio (OR)|1.164|||=|0.442|TWO_SIDED|95.0|0.79|1.714|||Regression, Logistic|p-values have been calculated using logistic regression with factors for treatment, region, and baseline disease status.||Odds Ratio: Epratuzumab/Placebo calculated using logistic regression with factors for treatment, region, and baseline disease status.||1.714|0.790|=0.442
70972581|NCT02787850|141451979|OTHER||sucess proportion|86.8|||||TWO_SIDED|95.0|71.9|95.6||||||||95.6|71.9|
70972582|NCT02787850|141451979|OTHER||success proportion|76.7|||||TWO_SIDED|95.0|57.7|90.1||||||||90.1|57.7|
70972583|NCT02787850|141451979|OTHER||success proportion|87.7|||||TWO_SIDED|95.0|76.3|94.9||||||||94.9|76.3|
70972584|NCT02787850|141451979|OTHER||success proportion|85.2|||||TWO_SIDED|95.0|66.3|95.8||||||||95.8|66.3|
71094270|NCT01482221|141696460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74|STANDARD_ERROR_OF_MEAN|0.302||0.067|TWO_SIDED|95.0|0.962|3.141|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline CGI-S total score as a covariate.||3.141|0.962|0.067
71094271|NCT01482221|141696460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43|STANDARD_ERROR_OF_MEAN|0.297||0.23|TWO_SIDED|95.0|0.798|2.558|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline CGI-S total score as a covariate.||2.558|0.798|0.230
70972585|NCT02921971|141451988|SUPERIORITY||Least square (LS) Mean difference|-2.31|STANDARD_ERROR_OF_MEAN|1.21||0.0291|TWO_SIDED|95.0|-4.71|0.08||Above p-value is one-sided p-value. Threshold for significance is at 0.05 level.|Mixed-effect model with repeated measure|||Analysis was performed using mixed model repeated measures (MMRM) model. The model included fixed categorical effects of treatment group, randomization strata as per IVRS, timepoint, treatment-by-timepoint and strata-by-timepoint interactions, as well as the continuous fixed covariate of baseline and baseline-by-timepoint interactions.||0.08|-4.71|0.0291
70972586|NCT02322710|141451992|NON_INFERIORITY|Non-inferiority was demonstrated if the upper limit of the 95% confidence interval of the observed difference between healing rates at D21 (Urgotul® - Tullegras M.S.®) in the PP population did not exceed +10%.|Difference in Percentages|1.2|STANDARD_DEVIATION|4.5|||ONE_SIDED|97.5||10.0||||||||10.0||
70972587|NCT04316585|141452009|SUPERIORITY||Mean Difference (Final Values)|-2.28|||||TWO_SIDED|95.0|-9.19|8.28|||Bayesian Logistic Regression Model|The model was adjusted for treatment (GSK2982772 vs placebo), baseline PASI score and prior biologic use (yes/no).|Posterior median and 95% CrI for the true difference in proportion of responders (GSK2982772 - placebo).|Bayesian logistic regression. An informative prior was used for the placebo response in this statistical analysis, the prior for placebo response rate was of the form: 90% weight on Be (5.39, 69) and 10% on Be (1/3,1/3). The prior was derived from historical data from similar clinical trials using meta-analytic predictive prior (MAP) approach. All other parameters took vague priors.||8.28|-9.19|
70972588|NCT04316585|141452009|SUPERIORITY||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-4.81|8.07|||Bayesian Logistic Regression Model|The model was adjusted for treatment (GSK2982772 vs placebo), baseline PASI score and prior biologic use (yes/no).|Posterior median and 95% CrI for the true difference in proportion of responders (GSK2982772 - placebo).|||8.07|-4.81|
70972589|NCT00130832|141452021|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (concomitant group minus staggered group) for subjects who achieve neutralizing antibody titers \[NA\] ≥1:8 greater than -10%.|Seroprotection Rate Difference|-0.5|||<|0.001||95.0|-2.2|1.4|||Miettinen and Nurminen's|Comparing seroprotection rate difference with the non-inferiority margin of 0.10 with Miettinen and Nurminen's method.||Seroprotection rate (proportion of subjects who achieve the seroprotection criteria: neutralizing antibody titers \[NA\] ≥1:8) for poliovirus type 1||1.4|-2.2|<0.001
71094272|NCT01482221|141696461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38|STANDARD_ERROR_OF_MEAN|0.292||0.268|TWO_SIDED|95.0|0.78|2.447|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline CGI-S total score as a covariate.||2.447|0.780|0.268
71094273|NCT01482221|141696461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97|STANDARD_ERROR_OF_MEAN|0.303||0.909|TWO_SIDED|95.0|0.533|1.75|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline CGI-S total score as a covariate.||1.750|0.533|0.909
71094274|NCT01482221|141696462|SUPERIORITY_OR_OTHER||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.87||0.505|TWO_SIDED|95.0|-2.29|1.13||Analysis for change in QIDS-SR-16 total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction are fixed effects in the model; pooled center is a random effect.||1.13|-2.29|0.505
71094275|NCT01482221|141696462|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.88||0.842|TWO_SIDED|95.0|-1.56|1.91||Analysis for change in QIDS-SR-16 total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction are fixed effects in the model; pooled center is a random effect.||1.91|-1.56|0.842
71094276|NCT01482221|141696462|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.89||0.788|TWO_SIDED|95.0|-1.98|1.51||Analysis for change in QIDS-SR-16 total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction are fixed effects in the model; pooled center is a random effect.||1.51|-1.98|0.788
71094277|NCT01482221|141696462|SUPERIORITY_OR_OTHER||LS mean difference|1.4|STANDARD_ERROR_OF_MEAN|0.9||0.133|TWO_SIDED|95.0|-0.42|3.12||Analysis for changed in QIDS-SR-16 total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction are fixed effects in the model; pooled center is a random effect.||3.12|-0.42|0.133
70919713|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.025|||||||Wilcoxon (Mann-Whitney)|||Month 36: Relief (observer)||||0.025
70919714|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Week 12: Pliability (observer)||||0.0020
70919715|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Month 12: Pliability (observer)||||0.14
70919716|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||Month 36: Pliability (observer)||||0.0014
70919717|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 12: Surface Area (observer)||||0.0001
70919718|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.023|||||||Wilcoxon (Mann-Whitney)|||Month 12: Surface Area (observer)||||0.023
70919719|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.045|||||||Wilcoxon (Mann-Whitney)|||Month 36: Surface Area (observer)||||0.045
70919720|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||Week 12: Total Score (observer)||||0.0005
70919721|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.085|||||||Wilcoxon (Mann-Whitney)|||Month 12: Total Score (observer)||||0.085
70919722|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Month 36: Total Score (observer)||||0.030
70919723|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||Week 12: Overall Opinion (observer)||||0.0015
70919724|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.076|||||||Wilcoxon (Mann-Whitney)|||Month 12: Overall Opinion (observer)||||0.076
70919725|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Month 36: Overall Opinion (observer)||||0.15
70919726|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Week 12: Painful (patient)||||0.72
70919727|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||Month 12: Painful (patient)||||0.97
70919728|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||Month 36: Painful (patient)||||0.82
70919729|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||Week 12: Itching (patient)||||0.86
70919730|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||Month 12: Itching (patient)||||0.84
70919731|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Month 36: Itching (patient)||||0.76
70919732|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Week 12: Color (patient)||||0.41
70919733|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||Month 12: Color (patient)||||0.98
70919734|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Month 36: Color (patient)||||0.76
70919735|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||Week 12: Stiffness (patient)||||0.43
70919736|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Month 12: Stiffness (patient)||||0.25
70919737|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||Month 36: Stiffness (patient)||||0.017
70919738|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Week 12: Thickness (patient)||||0.13
70919739|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||Month 12: Thickness (patient)||||0.33
70919740|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||Month 36: Thickness (patient)||||0.65
70919741|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Week 12: Irregularity (patient)||||0.18
70919742|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Month 12: Irregularity (patient)||||0.38
70919743|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Month 36: Irregularity (patient)||||0.080
70919744|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Week 12: Total Score (patient)||||0.28
70919745|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Month 12: Total Score (patient)||||0.44
70919746|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Month 36: Total Score (patient)||||0.19
70919747|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Week 12: Overall Opinion (patient)||||0.16
70919748|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Week 12: Overall Opinion (patient)||||0.23
70919749|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.079|||||||Wilcoxon (Mann-Whitney)|||Month 36: Overall Opinion (patient)||||0.079
71094278|NCT03086343|141696463|NON_INFERIORITY|The non-inferiority of upadacitinib 15 mg versus abatacept was tested using the 95% confidence interval (CI) of treatment difference against a non-inferiority margin of 0.6.|LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.69|-0.35||The ANCOVA model included treatment as the fixed factor; corresponding baseline value and the stratification factor of prior bDMARD used as covariates.|ANCOVA||Treatment Difference = Upadacitinib 15 mg - Abatacept|In order to preserve Type I error, a step-down approach was used to test the primary and ranked secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.||-0.35|-0.69|< 0.001
71094279|NCT03086343|141696464|SUPERIORITY||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.69|-0.35||This comparison was a ranked secondary endpoint in the pre-specified multiplicity testing sequence.|ANCOVA|The ANCOVA model included treatment as the fixed factor; corresponding baseline value and the stratification factor of prior bDMARD used as covariates|Treatment Difference = Upadacitinib 15 mg - Abatacept|In order to preserve Type I error, a step-down approach was used to test the primary and ranked secondary endpoints in a pre specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.||-0.35|-0.69|< 0.001
70919750|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Wilcoxon (Mann-Whitney)|||Week 12: Pain not within Scar (patient)||||0.0018
70919751|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||Month 12: Pain not within Scar (patient)||||0.053
70919752|NCT01796236|141330206|SUPERIORITY_OR_OTHER|||||||0.068|||||||Wilcoxon (Mann-Whitney)|||Month 36: Pain not within Scar (patient)||||0.068
70919753|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Baseline: Comprehensive Health State (HUI3)||||0.90
70919754|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||Week 24: Comprehensive Health State (HUI3)||||0.43
70972590|NCT00130832|141452021|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (concomitant group minus staggered group) for subjects who achieve neutralizing antibody titers \[NA\] ≥1:8 greater than -10%.|Seroprotection Rate Difference|0.0|||<|0.001||95.0|-1.4|1.6|||Miettinen and Nurminen's|Comparing seroprotection rate difference with the non-inferiority margin of 0.10 with Miettinen and Nurminen's method.||Seroprotection rate (proportion of subjects who achieve the seroprotection criteria: neutralizing antibody titers \[NA\] ≥1:8) for poliovirus type 2||1.6|-1.4|<0.001
70972591|NCT00130832|141452021|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (concomitant group minus staggered group) for subjects who achieve neutralizing antibody titers \[NA\] ≥1:8 greater than -10%.|Seroprotection Rate Difference|-0.1|||<|0.001||95.0|-2.3|2.3|||Miettinen and Nurminen's|Comparing seroprotection rate difference with the non-inferiority margin of 0.10 with Miettinen and Nurminen's method.||Seroprotection rate (proportion of subjects who achieve the seroprotection criteria: neutralizing antibody titers \[NA\] ≥1:8) for poliovirus type 3||2.3|-2.3|<0.001
70972592|NCT00130832|141452022|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the GMT ratio (concomitant group over staggered group) greater than 0.50.|GMT Ratio|0.54||||0.277||95.0|0.42|0.69|||ANOVA|ANOVA model on log titer of serum anti-rotavirus IgA||||0.69|0.42|0.277
70972593|NCT00130832|141452022|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (concomitant group minus staggered group) for subjects who achieve 3-fold rise in serum anti-rotavirus IgA greater than -10%.|Percentage Point Difference|-4.4||||0.002||95.0|-8.0|-1.4|||Miettinen and Nurminen's|Comparing percentage difference with the non-inferiority margin of 10 percentage point with Miettinen and Nurminen's method.|Percentage point difference (concomitant - staggered)|||-1.4|-8.0|0.002
70972594|NCT02944448|141452029|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.7093|TWO_SIDED|95.0|-0.4|0.5|||Mixed Models Analysis|||||0.5|-0.4|0.7093
70972595|NCT02944448|141452030|SUPERIORITY||Mean Difference (Final Values)|-2.8||||0.6007|TWO_SIDED|95.0|-13.1|7.6|||Mixed Models Analysis|||||7.6|-13.1|0.6007
70972596|NCT02944448|141452031|SUPERIORITY||Median Difference (Final Values)|-0.8||||0.4563|TWO_SIDED|95.0|-3.0|1.4|||Mixed Models Analysis|||||1.4|-3.0|0.4563
70972597|NCT02944448|141452032|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.8693|TWO_SIDED|95.0|-1.0|0.8|||Mixed Models Analysis|||||0.8|-1.0|0.8693
70972598|NCT02944448|141452033|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.6516|TWO_SIDED|95.0|-9.1|5.7|||Mixed Models Analysis|||||5.7|-9.1|0.6516
70972599|NCT02944448|141452034|SUPERIORITY||Odds Ratio (OR)|0.7||||0.1033|TWO_SIDED|95.0|0.5|1.1|||Regression, Logistic|Logistic regression, including treatment, baseline weekly pain score, and OA joint as independent variables.|Ratio between treatment odds of achieving a treatment response.|||1.1|0.5|0.1033
70972600|NCT02944448|141452035|SUPERIORITY||Odds Ratio (OR)|0.8||||0.2831|TWO_SIDED|95.0|0.5|1.2|||Regression, Logistic|Logistic regression, including treatment, baseline weekly pain score, and OA joint as independent variables.|Ratio between treatment odds of achieving a treatment response.|||1.2|0.5|0.2831
70919755|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Month 12: Comprehensive Health State (HUI3)||||0.23
70919756|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||Month 36: Comprehensive Health State (HUI3)||||0.019
70919757|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.079|||||||Wilcoxon (Mann-Whitney)|||Baseline: Vision (HUI3)||||0.079
70919758|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||Week 24: Vision (HUI3)||||0.96
70919759|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||Month 12: Vision (HUI3)||||0.55
70919760|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Month 36: Vision (HUI3)||||0.64
70919761|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Baseline: Hearing (HUI3)||||0.76
70919762|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.059|||||||Wilcoxon (Mann-Whitney)|||Week 24: Hearing (HUI3)||||0.059
71094280|NCT03086343|141696465|SUPERIORITY||Mean Difference|16.8|||<|0.001|TWO_SIDED|95.0|10.4|23.2||This comparison was a ranked secondary endpoint in the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|The stratification factor of prior failed bDMARD was used.|Treatment Difference = Upadacitinib 15 mg - Abatacept|In order to preserve Type I error, a step-down approach was used to test the primary and ranked secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.||23.2|10.4|< 0.001
71094281|NCT01047501|141696466|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-21.5|||<|0.0001|TWO_SIDED|95.0|-26.7|-16.2||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|A sample size of 194 was required to provide 90.6% power to detect a difference of 15% between AMR101 4 g/day and placebo in percent change from baseline in fasting TG levels, assuming an SD of 45% in TG measurements and a significance level (p value) of 0.05, and 80% power to demonstrate noninferiority (p 0.025, 1-sided) of the LDL-cholesterol response between AMR101 4 g/day and placebo with a +6% margin. To accommodate a 10% drop-out rate, recruitment was planned for 648 randomized patients.||-16.2|-26.7|<0.0001
71094282|NCT01047501|141696466|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-10.1||||0.0005|TWO_SIDED|95.0|-15.7|-4.5|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-4.5|-15.7|0.0005
70919763|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Month 12: Hearing (HUI3)||||0.38
70919764|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Month 36: Hearing (HUI3)||||0.14
70919765|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||Baseline: Speech (HUI3)||||0.73
70919766|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||Week 24: Speech (HUI3)||||0.65
70919767|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||Month 12: Speech (HUI3)||||1.00
70919768|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||Month 36: Speech (HUI3)||||0.35
70919769|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Baseline: Ambulation (HUI3)||||0.50
70919770|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Week 24: Ambulation (HUI3)||||0.40
70919771|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Month 12: Ambulation (HUI3)||||0.21
70919772|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Month 36: Ambulation (HUI3)||||0.0010
70919773|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Baseline: Emotion (HUI3)||||0.13
70919774|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||Week 24: Emotion (HUI3)||||0.96
70919775|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Month 12: Emotion (HUI3)||||0.75
70919776|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Month 36: Emotion (HUI3)||||0.20
70919777|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Baseline: Cognition (HUI3)||||0.95
70919778|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||Week 24: Cognition (HUI3)||||0.31
70919779|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Month 12: Cognition (HUI3)||||0.15
70919780|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Month 36: Cognition (HUI3)||||0.19
70919781|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Baseline: Pain (HUI3)||||0.41
70919782|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Week 24: Pain (HUI3)||||0.30
70919783|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||Month 12: Pain (HUI3)||||0.42
70919784|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Month 36: Pain (HUI3)||||0.040
70919785|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Baseline: Comprehensive Health State (HUI2)||||0.99
70919786|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Week 24: Comprehensive Health State (HUI2)||||0.88
70919787|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||Month 12: Comprehensive Health State (HUI2)||||0.32
70919788|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.0084|||||||Wilcoxon (Mann-Whitney)|||Month 36: Comprehensive Health State (HUI2)||||0.0084
70919789|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||Baseline: Sensation (HUI2)||||0.77
70919790|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Week 24: Sensation (HUI2)||||0.95
70919791|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||Month 12: Sensation (HUI2)||||0.60
70919792|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Month 36: Sensation (HUI2)||||0.48
70919793|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Baseline: Mobility (HUI2)||||0.51
70919794|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||Week 24: Mobility (HUI2)||||0.42
70919795|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||Month 12: Mobility (HUI2)||||0.22
70919796|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Wilcoxon (Mann-Whitney)|||Month 36: Mobility (HUI2)||||0.0018
70919797|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Baseline: Emotion (HUI2)||||0.30
70919798|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Week 24: Emotion (HUI2)||||0.52
70919799|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Month 12: Emotion (HUI2)||||0.47
70919800|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Month 36: Emotion (HUI2)||||0.18
71094283|NCT01047501|141696467|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo with a significance level of 0.05. Non-inferiority tests for percent change from baseline in LDL-C were performed between AMR101 and placebo to determine if AMR101 was statistically non-inferior to placebo with regard to increases in LDL-C. The pre-specified LDL-C criterion for noninferiority was the upper boundary 97.5% confidence interval not crossing the +6% threshold.|Median Difference (Final Values)|-6.2||||0.0067|TWO_SIDED|95.0|-10.5|-1.7|||Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|A sample size of 194 was required to provide 90.6% power to detect a difference of 15% between AMR101 4 g/day and placebo in percent change from baseline in fasting TG levels, assuming an SD of 45% in TG measurements and a significance level (p value) of 0.05, and 80% power to demonstrate noninferiority (p 0.025, 1-sided) of the LDL-cholesterol response between AMR101 4 g/day and placebo with a +6% margin. To accommodate a 10% drop-out rate, recruitment was planned for 648 randomized patients.||-1.7|-10.5|0.0067
71094284|NCT01047501|141696467|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo with a significance level of 0.05. Non-inferiority tests for percent change from baseline in LDL-C were performed between AMR101 and placebo to determine if AMR101 was statistically non-inferior to placebo with regard to increases in LDL-C. The pre-specified LDL-C criterion for noninferiority was the upper boundary 97.5% confidence interval not crossing the +6% threshold.|Median Difference (Final Values)|-3.6||||0.0867|TWO_SIDED|95.0|-7.9|0.5|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||0.5|-7.9|0.0867
70972601|NCT02944448|141452036|SUPERIORITY||Odds Ratio (OR)|1.3||||0.1959|TWO_SIDED|95.0|0.9|2.0|||Regression, Logistic|Logistic regression with treatment as a main effect and OA joint as a covariate.|"Ratio between treatment odds of having a PGIC of Very Much Improved or Much Improved."|||2.0|0.9|0.1959
70972602|NCT02944448|141452037|SUPERIORITY|||||||0.2858|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum test stratified by Primary OA joint (Hip or Knee) and Baseline Week Mean of the Daily NRS (\<6.7 or \>=6.7) (Van Elteren test).||||||0.2858
70972603|NCT02944448|141452038|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8002|TWO_SIDED|95.0|0.3|2.7|||Regression, Logistic|Logistic regression, including treatment, baseline pain score, and OA joint as independent variables.|Ratio between treatment odds of withdrawing from treatment due to lack of analgesic efficacy.|||2.7|0.3|0.8002
70972604|NCT04681170|141452050|OTHER||Mean Difference (Net)|-53.91|||<|0.0001|TWO_SIDED|95.0|-61.859|-45.9612|||t-test, 1 sided|||This was a single-arm study, no comparative group can be assigned; the comparison made for the primary efficacy endpoint is done only between baseline and Week 24 in paediatric subjects (5 to ≤17 years of age). Analysis was made using the one-sample t-test to test the null hypothesis that the percentage change from Baseline was equal to zero against the alternative hypothesis that the percentage change from Baseline was not equal to zero.||-45.9612|-61.8590|<0.0001
70972605|NCT04986202|141452069|SUPERIORITY||Mean Difference (Final Values)|-0.92||||0.537|TWO_SIDED|95.0|-3.86|2.02||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|||2.02|-3.86|0.537
70972606|NCT04986202|141452069|SUPERIORITY||Mean Difference (Final Values)|-1.81||||0.221|TWO_SIDED|95.0|-4.71|1.09||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|||1.09|-4.71|0.221
70972607|NCT04986202|141452070|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.559|TWO_SIDED|95.0|-5.7|10.5||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|||10.5|-5.7|0.559
70972608|NCT04986202|141452070|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.195|TWO_SIDED|95.0|-2.7|13.3||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|||13.3|-2.7|0.195
70972609|NCT04986202|141452071|SUPERIORITY||Mean Difference (Final Values)|-1.65||||0.289|TWO_SIDED|95.0|-4.71|1.41||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.41|-4.71|0.289
70972610|NCT04986202|141452071|SUPERIORITY||Mean Difference (Final Values)|-0.87||||0.571|TWO_SIDED|95.0|-3.86|2.13||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||2.13|-3.86|0.571
70972611|NCT04986202|141452071|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.89|TWO_SIDED|95.0|-3.8|3.3||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||3.30|-3.80|0.890
70972612|NCT04986202|141452071|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.558|TWO_SIDED|95.0|-4.55|2.46||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||2.46|-4.55|0.558
70972613|NCT04986202|141452072|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.619|TWO_SIDED|95.0|-11.1|6.6||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||6.6|-11.1|0.619
70919801|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||Baseline: Cognition (HUI2)||||0.82
70919802|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Week 24: Cognition (HUI2)||||0.41
70919803|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Month 12: Cognition (HUI2)||||0.14
70919804|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Month 36: Cognition (HUI2)||||0.25
70919805|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||Baseline: Self Care (HUI2)||||0.59
70919806|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||Week 24: Self Care (HUI2)||||1.00
70919807|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||Month 12: Self Care (HUI2)||||0.55
70919808|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Month 36: Self Care (HUI2)||||0.14
70919809|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Baseline: Pain (HUI2)||||0.75
70919810|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Week 24: Pain (HUI2)||||0.63
70919811|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Month 12: Pain (HUI2)||||0.57
70919812|NCT01796236|141330207|SUPERIORITY_OR_OTHER|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||Month 36: Pain (HUI2)||||0.019
70919813|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||Baseline: Ease of Communication (Aided)||||0.047
70919814|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Baseline: Background Noise (Aided)||||0.23
70919815|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||Baseline: Reverberation (Aided)||||0.015
70919816|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Baseline: Aversiveness (Aided)||||0.13
70919817|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.041|||||||Wilcoxon (Mann-Whitney)|||Baseline: Global (Aided)||||0.041
70919818|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.071|||||||Wilcoxon (Mann-Whitney)|||Baseline: Ease of Communication (Unaided)||||0.071
70919819|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Baseline: Background Noise (Unaided)||||0.75
70919820|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||Baseline: Reverberation (Unaided)||||0.32
70919821|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Baseline: Aversiveness (Unaided)||||0.24
70919822|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Baseline: Global (Unaided)||||0.24
70919823|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Baseline: Ease of Communication (Benefit)||||0.12
70919824|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Baseline: Background Noise (Benefit)||||0.19
70919825|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.055|||||||Wilcoxon (Mann-Whitney)|||Baseline: Reverberation (Benefit)||||0.055
70919826|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Baseline: Aversiveness (Benefit)||||0.24
70919827|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.042|||||||Wilcoxon (Mann-Whitney)|||Baseline: Global (Benefit)||||0.042
70919828|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Week 24: Ease of Communication (Aided)||||0.19
70919829|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Week 24: Background Noise (Aided)||||0.99
70919830|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Week 24: Reverberation (Aided)||||0.24
70919831|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||Week 24: Aversiveness (Aided)||||0.73
70919832|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Week 24: Global (Aided)||||0.39
70919833|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Week 24: Ease of Communication (Unaided)||||0.24
70919834|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Week 24: Background Noise (Unaided)||||0.81
70919835|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Week 24: Reverberation (Unaided)||||0.34
70919836|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.038|||||||Wilcoxon (Mann-Whitney)|||Week 24: Aversiveness (Unaided)||||0.038
70919837|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||Week 24: Global (Unaided)||||0.53
70919838|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Week 24: Ease of Communication (Benefit)||||0.63
70919839|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||Week 24: Background Noise (Benefit)||||0.83
70919840|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Week 24: Reverberation (Benefit)||||0.71
70919841|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Week 24: Aversiveness (Benefit)||||0.16
70919842|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Week 24: Global (Benefit)||||0.81
70919843|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Month 12: Ease of Communication (Aided)||||0.51
70919844|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Month 12: Background Noise (Aided)||||0.47
70919845|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.93|||||||Wilcoxon (Mann-Whitney)|||Month 12: Reverberation (Aided)||||0.93
70919846|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||Month 12: Aversiveness (Aided)||||0.62
70919847|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Month 12: Global (Aided)||||0.63
70919848|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Month 12: Ease of Communication (Unaided)||||0.18
70919849|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Month 12: Background Noise (Unaided)||||0.76
70972614|NCT04986202|141452072|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.522|TWO_SIDED|95.0|-5.8|11.4||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||11.4|-5.8|0.522
71094285|NCT01047501|141696468|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-13.6||||0.0001|TWO_SIDED|95.0|-17.2|-9.9||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-9.9|-17.2|0.0001
70972615|NCT04986202|141452072|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.267|TWO_SIDED|95.0|-4.4|15.8||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||15.8|-4.4|0.267
71094286|NCT01047501|141696468|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-5.5||||0.014|TWO_SIDED|95.0|-9.4|-1.7|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-1.7|-9.4|0.0140
70972616|NCT04986202|141452072|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.657|TWO_SIDED|95.0|-7.6|12.1||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||12.1|-7.6|0.657
70972617|NCT04986202|141452073|SUPERIORITY||Geometric mean ratio|0.95||||0.312|TWO_SIDED|95.0|0.86|1.05||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|NT-proBNP change from baseline at 16 weeks||1.05|0.86|0.312
70972618|NCT04986202|141452073|SUPERIORITY||Geometric mean ratio|0.91||||0.07|TWO_SIDED|95.0|0.83|1.01||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|NT-proBNP change from baseline at 16 weeks||1.01|0.83|0.070
70972619|NCT04986202|141452073|SUPERIORITY||Geometric mean ratio|1.01||||0.911|TWO_SIDED|95.0|0.91|1.12||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|NT-proBNP change from baseline at 24 weeks||1.12|0.91|0.911
70972620|NCT04986202|141452073|SUPERIORITY||Geometric mean ratio|1.01||||0.837|TWO_SIDED|95.0|0.91|1.12||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|NT-proBNP change from baseline at 24 weeks||1.12|0.91|0.837
70972621|NCT04986202|141452073|SUPERIORITY||Geometric mean ratio|0.95||||0.37|TWO_SIDED|95.0|0.84|1.07||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|NT-proBNP change from baseline at 48 weeks||1.07|0.84|0.370
70972622|NCT04986202|141452073|SUPERIORITY||Geometric mean ratio|0.93||||0.205|TWO_SIDED|95.0|0.83|1.04||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|NT-proBNP change from baseline at 48 weeks||1.04|0.83|0.205
70972623|NCT04986202|141452074|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.183|TWO_SIDED|95.0|-0.2|1.2||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||1.2|-0.2|0.183
70972624|NCT04986202|141452074|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.898|TWO_SIDED|95.0|-0.8|0.7||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||0.7|-0.8|0.898
70972625|NCT04986202|141452074|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.316|TWO_SIDED|95.0|-0.4|1.1||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.1|-0.4|0.316
70972626|NCT04986202|141452074|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.934|TWO_SIDED|95.0|-0.7|0.8||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||0.8|-0.7|0.934
70972627|NCT04986202|141452075|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.725|TWO_SIDED|95.0|-1.647|2.366||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||2.366|-1.647|0.725
70972628|NCT04986202|141452075|SUPERIORITY||Mean Difference (Final Values)|-0.594||||0.555|TWO_SIDED|95.0|-2.571|1.382||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||1.382|-2.571|0.555
70972629|NCT04986202|141452075|SUPERIORITY||Mean Difference (Final Values)|0.657||||0.586|TWO_SIDED|95.0|-1.71|3.025||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||3.025|-1.710|0.586
70972630|NCT04986202|141452075|SUPERIORITY||Mean Difference (Final Values)|-0.815||||0.486|TWO_SIDED|95.0|-3.108|1.478||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.478|-3.108|0.486
70972631|NCT04986202|141452076|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.968|TWO_SIDED|95.0|-4.1|3.9||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||3.9|-4.1|0.968
70972632|NCT04986202|141452076|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.251|TWO_SIDED|95.0|-6.3|1.6||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||1.6|-6.3|0.251
70972633|NCT04986202|141452076|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.872|TWO_SIDED|95.0|-4.8|5.7||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||5.7|-4.8|0.872
70972634|NCT04986202|141452076|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.682|TWO_SIDED|95.0|-6.2|4.1||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|No formal hypothesis testing and p-value is not adjusted for multiple comparisons.|Change from baseline at 24 weeks||4.1|-6.2|0.682
70972635|NCT04986202|141452078|SUPERIORITY||Geometric mean ratio|1.029||||0.76|TWO_SIDED|95.0|0.857|1.236||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||1.236|0.857|0.760
70972636|NCT04986202|141452078|SUPERIORITY||Geometric mean ratio|1.209||||0.039|TWO_SIDED|95.0|1.01|1.448||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Change from baseline at 16 weeks||1.448|1.010|0.039
71094287|NCT01047501|141696469|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-24.4||||0.0001|TWO_SIDED|95.0|-31.9|-17.0||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-17.0|-31.9|0.0001
71094288|NCT01047501|141696469|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-10.5||||0.017|TWO_SIDED|95.0|-18.3|-2.5|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-2.5|-18.3|0.0170
70972637|NCT04986202|141452078|SUPERIORITY||Geometric mean ratio|1.111||||0.241|TWO_SIDED|95.0|0.931|1.326||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.326|0.931|0.241
70972638|NCT04986202|141452078|SUPERIORITY||Geometric mean ratio|1.19||||0.049|TWO_SIDED|95.0|1.001|1.414||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.414|1.001|0.049
70972639|NCT04986202|141452078|SUPERIORITY||Geometric mean ratio|1.151||||0.158|TWO_SIDED|95.0|0.946|1.401||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||1.401|0.946|0.158
70972640|NCT04986202|141452078|SUPERIORITY||Geometric mean ratio|1.159||||0.131|TWO_SIDED|95.0|0.957|1.404||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||1.404|0.957|0.131
70972641|NCT04986202|141452079|SUPERIORITY||Geometric mean ratio|1.0111||||0.874|TWO_SIDED|95.0|0.8819|1.1592||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||1.1592|0.8819|0.874
70972642|NCT04986202|141452079|SUPERIORITY||Geometric mean ratio|0.9157||||0.2|TWO_SIDED|95.0|0.8002|1.0479||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||1.0479|0.8002|0.200
71094289|NCT01047501|141696470|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-19.0||||0.0001|TWO_SIDED|95.0|-22.2|-15.7||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-15.7|-22.2|0.0001
70972643|NCT04986202|141452079|SUPERIORITY||Geometric mean ratio|1.1063||||0.135|TWO_SIDED|95.0|0.969|1.2631||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.2631|0.9690|0.135
70972644|NCT04986202|141452079|SUPERIORITY||Geometric mean ratio|1.0842||||0.22|TWO_SIDED|95.0|0.9527|1.2339||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.2339|0.9527|0.220
70972645|NCT04986202|141452079|SUPERIORITY||Geometric mean ratio|1.0496||||0.467|TWO_SIDED|95.0|0.9211|1.196||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||1.1960|0.9211|0.467
70972646|NCT04986202|141452079|SUPERIORITY||Geometric mean ratio|1.0312||||0.636|TWO_SIDED|95.0|0.908|1.1711||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||1.1711|0.9080|0.636
70972647|NCT02118792|141452089|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
70972648|NCT02787863|141452145|OTHER||||||<|0.05|||||||McNemar|||||||<0.05
70972649|NCT02787863|141452146|OTHER||||||<|0.05|||||||McNemar|||||||<0.05
70972650|NCT01978093|141452154|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% CI for the difference (HibCY group minus the PedHIB group) in the percentage of subjects with anti-PRP concentrations ≥1.0 mg/mL is to be≥-10% (clinical limit for non-inferiority).|Difference in percentage of subjects|0.96|||||TWO_SIDED|95.0|-2.12|4.3|||Group difference in proportions|Before concluding on the primary objectives for Rotarix, Prevnar 13 and Havrix, this primary objective regarding anti-PRP needs to be reached||Difference between HibCY and PedHIB groups in percentage of subjects with anti-PRP concentrations equal to or above the cut-off value of 1.0 µg/mL one month after the fourth dose in HibCY Group and third dose in PedHIB Group.||4.30|-2.12|
71094290|NCT01047501|141696470|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-8.0||||0.0004|TWO_SIDED|95.0|-11.6|-4.5|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-4.5|-11.6|0.0004
70972651|NCT01978093|141452155|NON_INFERIORITY|Non-inferiority is concluded if lower limit of the two-sided standardized asymptotic 97.5% CI on the ratio of anti-rotavirus IgA GMC (HibCY group over PedHIB group) is to be ≥0.5|Adjusted GMC ratios|1.21|||||TWO_SIDED|97.5|0.77|1.9|||ANCOVA|GMC adjusted for BS sub-cohorts;97.5% confidence interval calculated for adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 Post dose 3)\& Epoch 002 (Havrix \& Prevnar13 post dose 4),a Bonferroni correction is used in order to test these objectives(1.25% 1sided for Epoch 001 \& 002)|GMC ratios between HibCY and PedHIB groups for anti-Rota IgA concentrations 2 months after the second dose of Rotarix vaccine||1.90|0.77|
70972652|NCT01978093|141452156|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 1 is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.18|||||TWO_SIDED|97.5|0.95|1.47|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio (Ancova Model: adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix \& Prevnar13 post dose 4),Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 1 concentrations one month after the third dose.||1.47|0.95|
70972653|NCT01978093|141452156|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 3 is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.15|||||TWO_SIDED|97.5|0.93|1.42|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 3 concentrations one month after the third dose.||1.42|0.93|
70972654|NCT01978093|141452156|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 4 is to be≥ 0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.08|||||TWO_SIDED|97.5|0.9|1.31|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 4 concentrations one month after the third dose.||1.31|0.90|
71094291|NCT01047501|141696471|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-9.3||||0.0001|TWO_SIDED|95.0|-12.3|-6.1||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-6.1|-12.3|0.0001
71094292|NCT01047501|141696471|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-3.8||||0.017|TWO_SIDED|95.0|-6.9|-0.7|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-0.7|-6.9|0.0170
71094293|NCT00429299|141696484|NON_INFERIORITY_OR_EQUIVALENCE|An exploratory comparison between the combined two single anti-HER2 arms and the dual anti-HER2 arm was performed (Arm 3 versus Arms 1 and 2).|percentage of participants|25.0||||0.019||90.0|13.1|36.9||Exploratory analysis|Chi-squared||The estimated value represents the percentage of particpants in the CT plus trastuzumab treatment group with pathological complete response.|||36.9|13.1|0.019
71094294|NCT00429299|141696484|SUPERIORITY_OR_OTHER||percentage of participants|26.3||||||90.0|14.5|38.1|||||The estimated value represents the percentage of particpants in the CT plus lapatinib 1500 mg treatment group with pathological complete response.|||38.1|14.5|
71094295|NCT00429299|141696484|SUPERIORITY_OR_OTHER||percentage of participants|46.7|||||TWO_SIDED|90.0|34.4|58.9|||||The estimated value represents the percentage of particpants in the CT plus traztuzumab plus lapatinib 1000 mg treatment group with pathological complete response.|||58.9|34.4|
71094296|NCT04871113|141696504|OTHER||Emax|-1.848|||||TWO_SIDED|95.0|-2.225|-1.472|||||Emax is defined as maximum response.|||-1.472|-2.225|
71094297|NCT04871113|141696504|OTHER||EC50|68.578|||||TWO_SIDED|95.0|15.866|121.29|||||EC50 is defined as the dose (in mg) that attains the 50% of the maximal effect.|||121.290|15.866|
71094298|NCT04871113|141696504|OTHER||s2e|0.257|||||TWO_SIDED|95.0|0.145|0.368|||||e is defined as random error assumed to be normally distributed with mean zero and constant variance (s2).|||0.368|0.145|
71094299|NCT00315822|141696513|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.94||||0.8|TWO_SIDED|95.0|0.52|1.68|||Cochran-Mantel-Haenszel|||||1.68|0.52|0.80
70919850|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Month 12: Reverberation (Unaided)||||0.17
70919851|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||Month 12: Aversiveness (Unaided)||||0.29
70919852|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Month 12: Global (Unaided)||||0.40
70919853|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||Month 12: Ease of Communication (Benefit)||||0.29
70919854|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Month 12: Background Noise (Benefit)||||0.90
70919855|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Month 12: Reverberation (Benefit)||||0.24
71094300|NCT01257542|141696514|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.252|TWO_SIDED|95.0|0.59|1.15||p-value was calculated using negative binomial regression model with treatment, site and baseline of cough count terms with log (exposure time) as the offset parameter.|Negative binomial regression|||Odds Ratio and corresponding 95 percent (%) confidence interval (CI) were assessed from the negative binomial regression model.||1.15|0.59|0.252
71094301|NCT01257542|141696515|SUPERIORITY_OR_OTHER||LS mean difference|-0.26||||0.134|TWO_SIDED|95.0|-0.6|0.08||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||Treatment difference and corresponding 95% CI were calculated based on least-square (LS) means from analysis of variance (ANOVA) model.||0.08|-0.60|0.134
71094302|NCT01257542|141696516|SUPERIORITY_OR_OTHER||LS mean difference|-0.06||||0.768|TWO_SIDED|95.0|-0.45|0.33||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||1 hour: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.33|-0.45|0.768
71094303|NCT01257542|141696516|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.358|TWO_SIDED|95.0|-0.64|0.23||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||2 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.23|-0.64|0.358
71094304|NCT01257542|141696516|SUPERIORITY_OR_OTHER||LS mean difference|-0.32||||0.139|TWO_SIDED|95.0|-0.74|0.1||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||3 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.10|-0.74|0.139
71094305|NCT01257542|141696516|SUPERIORITY_OR_OTHER||LS mean difference|-0.21||||0.364|TWO_SIDED|95.0|-0.68|0.25||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||4 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.25|-0.68|0.364
71094306|NCT01257542|141696516|SUPERIORITY_OR_OTHER||LS mean difference|-0.46||||0.039|TWO_SIDED|95.0|-0.9|-0.02||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||5 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||-0.02|-0.90|0.039
70919856|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Month 12: Aversiveness (Benefit)||||0.45
70919857|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||Month 12: Global (Benefit)||||0.37
70919858|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||Month 36: Ease of Communication (Aided)||||0.84
70919859|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Month 36: Background Noise (Aided)||||0.57
70919860|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Month 36: Reverberation (Aided)||||0.71
70919861|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Month 36: Aversiveness (Aided)||||0.99
71094307|NCT01257542|141696516|SUPERIORITY_OR_OTHER||LS mean difference|-0.29||||0.206|TWO_SIDED|95.0|-0.75|0.16||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||6 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.16|-0.75|0.206
71094308|NCT01257542|141696517|SUPERIORITY_OR_OTHER||LS mean difference|-0.49||||0.304|TWO_SIDED|95.0|-1.43|0.45||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||Treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.45|-1.43|0.304
71094309|NCT01257542|141696518|SUPERIORITY_OR_OTHER||LS mean difference|-0.03||||0.954|TWO_SIDED|95.0|-1.03|0.97||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||1 hour: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.97|-1.03|0.954
71094310|NCT01257542|141696518|SUPERIORITY_OR_OTHER||LS mean difference|-0.44||||0.426|TWO_SIDED|95.0|-1.54|0.65||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||2 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.65|-1.54|0.426
71094311|NCT01257542|141696518|SUPERIORITY_OR_OTHER||LS mean difference|-0.45||||0.396|TWO_SIDED|95.0|-1.49|0.6||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||3 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.60|-1.49|0.396
71094312|NCT01257542|141696518|SUPERIORITY_OR_OTHER||LS mean difference|-0.49||||0.402|TWO_SIDED|95.0|-1.63|0.66||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||4 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.66|-1.63|0.402
71094313|NCT01257542|141696518|SUPERIORITY_OR_OTHER||LS mean difference|-0.69||||0.204|TWO_SIDED|95.0|-1.75|0.38||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||5 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.38|-1.75|0.204
71094314|NCT01257542|141696518|SUPERIORITY_OR_OTHER||LS mean difference|-0.84||||0.179|TWO_SIDED|95.0|-2.06|0.39||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||6 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.39|-2.06|0.179
71094315|NCT01257542|141696519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.523|TWO_SIDED|95.0|-0.21|0.39||p-value was calculated from the Cochran-Mantel-Haenszel (CMH) test with modified ridit scores controlling site.|Cochran-Mantel-Haenszel|||Treatment difference and the associated 95% CI were based on the weighted Gamma statistics.||0.39|-0.21|0.523
71094316|NCT01257542|141696520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.796|TWO_SIDED|95.0|-0.35|0.24||p-value was calculated from the CMH test with modified ridit scores controlling site.|Cochran-Mantel-Haenszel|||Treatment difference and the associated 95% CI were based on the weighted Gamma statistics.||0.24|-0.35|0.796
71094317|NCT00693303|141696540|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||t-test, 2 sided|||||||.27
71094318|NCT00063622|141696571|SUPERIORITY_OR_OTHER|||||||0.001||||||Given the fact that there were two planned primary comparisons, Bonferroni-adjusted P values of less than 0.025 were considered to indicate statistical significance.|Mantel Haenszel|||The proportions in each active-treatment group (pioglitazone and vitamin E) in whom there was improvement in non-alcoholic steatohepatitis were compared with the proportion of subjects in the placebo group in whom there was improvement.||||0.001
71094319|NCT00063622|141696571|SUPERIORITY_OR_OTHER|||||||0.04||||||Given the fact that there were two planned primary comparisons, Bonferroni-adjusted P values of less than 0.025 were considered to indicate statistical significance.|Mantel Haenszel|||The proportions in each active-treatment group (pioglitazone and vitamin E) in whom there was improvement in non-alcoholic steatohepatitis were compared with the proportion of subjects in the placebo group in whom there was improvement.||||0.04
71094320|NCT00063622|141696572|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Fisher Exact|||||||0.005
71094321|NCT00063622|141696572|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71094322|NCT00063622|141696573|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Fisher Exact|||||||0.02
71094323|NCT00063622|141696573|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Fisher Exact|||||||0.004
71094324|NCT00063622|141696574|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Fisher Exact|||||||0.01
71094325|NCT00063622|141696574|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Fisher Exact|||||||0.08
71094326|NCT00063622|141696575|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Fisher Exact|||||||0.24
71094327|NCT00063622|141696575|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Fisher Exact|||||||0.12
71094328|NCT00063622|141696576|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Fisher Exact|||||||0.05
71094329|NCT00063622|141696576|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||||||0.001
71094330|NCT04502524|141696577|OTHER|||||||0.999|||||||Fisher Exact|||For overall satisfaction, a reliable estimate could not be calculated using a logistic regression model as all the responses were the same in the Vet Flexiquit arm. We calculated the p-value using the Fisher's exact test.||||.999
71094331|NCT04502524|141696578|OTHER||Slope|0.05||||0.852|TWO_SIDED|95.0|-0.46|0.56|||Regression, negative binomial|||||0.56|-0.46|0.852
71094332|NCT04502524|141696579|OTHER||Slope|-0.44||||0.451|TWO_SIDED|95.0|-1.6|0.71|||Regression, negative binomial|||||0.71|-1.60|0.451
71094333|NCT04502524|141696580|OTHER||Slope|-0.73||||0.508|TWO_SIDED|95.0|-1.46|0.003|||Regression, negative binomial|||||0.003|-1.46|0.508
71094334|NCT04502524|141696581|OTHER||Odds Ratio (OR)|0.65||||0.602|TWO_SIDED|95.0|0.13|3.32|||Regression, Logistic|||||3.32|0.13|0.602
71094335|NCT04502524|141696582|OTHER||Odds Ratio (OR)|0.94||||0.941|TWO_SIDED|95.0|0.17|5.29|||Regression, Logistic|||||5.29|0.17|0.941
71094336|NCT04502524|141696583|OTHER||Odds Ratio (OR)|0.61||||0.612|TWO_SIDED|95.0|0.09|4.12|||Regression, Logistic|||||4.12|0.09|0.612
71094337|NCT04502524|141696584|OTHER||Slope|0.56||||0.504|TWO_SIDED|95.0|-1.13|2.26|||Regression, Linear|||||2.26|-1.13|0.504
71094338|NCT04502524|141696585|OTHER||Slope|0.11||||0.67|TWO_SIDED|95.0|-0.4|0.61|||Regression, Linear|||||0.61|-0.40|0.670
71094339|NCT01018979|141696596|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|TWO_SIDED|||||P values less than 0.05 are considered statistically significant in this study.|t-test, 2 sided|||Analyze whether the mean fold increase from the baseline to the peak time change was significant or not.||||0.023
71094340|NCT01018979|141696596|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038|TWO_SIDED|||||P values less than 0.05 are considered statistically significant in this study.|t-test, 2 sided|||Analyze whether the mean fold increase from the baseline to the peak time change was significant or not.||||0.038
71094341|NCT00544882|141696607|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6346|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 2 time point. p-values \< 0.05 were considered statistically significant.||||0.6346
71094342|NCT00544882|141696607|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2757|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 4 time point.||||0.2757
71094343|NCT00544882|141696607|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1321|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 6 time point.||||0.1321
71094344|NCT00544882|141696607|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5543|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Days 19-20 time point.||||0.5543
71094345|NCT00544882|141696607|SUPERIORITY_OR_OTHER_LEGACY|||||||0.394|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 23 time point.||||0.3940
71094346|NCT00544882|141696607|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7891|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 24 time point.||||0.7891
71094347|NCT00544882|141696607|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4829|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 25 time point.||||0.4829
71094348|NCT00544882|141696607|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4526|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 27 time point.||||0.4526
71094349|NCT00544882|141696607|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2485|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 28 time point.||||0.2485
71094350|NCT00544882|141696607|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6252|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 2 time point.||||0.6252
71094351|NCT00544882|141696607|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4003|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 4 time point.||||0.4003
71094352|NCT00544882|141696607|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8841|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 6 time point.||||0.8841
71094353|NCT00544882|141696609|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8892|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 2 time point. p-values \< 0.05 were considered statistically significant.||||0.8892
71094354|NCT00544882|141696609|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7678|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 4 time point.||||0.7678
71094355|NCT00544882|141696609|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5782|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 6 time point.||||0.5782
71094356|NCT00544882|141696609|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8083|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Days 19-20 time point.||||0.8083
71094357|NCT00544882|141696609|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 23 time point.||||1.0000
71094358|NCT00544882|141696609|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4122|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 24 time point.||||0.4122
71094359|NCT00544882|141696609|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6675|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 25 time point.||||0.6675
71094360|NCT00544882|141696609|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8445|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 27 time point.||||0.8445
71094361|NCT00544882|141696609|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3772|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 28 time point.||||0.3772
71094362|NCT00544882|141696609|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1918|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 2 time point.||||0.1918
71094363|NCT00544882|141696609|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6675|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 4 time point.||||0.6675
71094364|NCT00544882|141696609|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9226|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 6 time point.||||0.9226
71094365|NCT00544882|141696610|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0979|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 2 time point. p-values \< 0.05 were considered statistically significant.||||0.0979
71094366|NCT00544882|141696610|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0629|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 4 time point.||||0.0629
71094367|NCT00544882|141696610|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8464|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 6 time point.||||0.8464
71094368|NCT00544882|141696610|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6316|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Days 19-20 time point.||||0.6316
71094369|NCT00544882|141696610|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 23 time point.||||0.3000
71094370|NCT00544882|141696610|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0955|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 24 time point.||||0.0955
71094371|NCT00544882|141696610|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1523|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 25 time point.||||0.1523
71094372|NCT00544882|141696610|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2809|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 27 time point.||||0.2809
71094373|NCT00544882|141696610|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8829|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 28 time point.||||0.8829
71094374|NCT00544882|141696610|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9262|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 2 time point.||||0.9262
71094375|NCT00544882|141696610|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7811|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 -Day 4 time point.||||0.7811
71094376|NCT00544882|141696610|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3703|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 6 time point.||||0.3703
71094377|NCT03043573|141696616|SUPERIORITY||Mean Difference (Final Values)|-0.7011||||0.9644|TWO_SIDED|95.0|-31.8605|30.4583|||t-test, 2 sided|||Baseline||30.4583|-31.8605|0.9644
70972655|NCT01978093|141452156|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 5 is to be ≥ 0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.18|||||TWO_SIDED|97.5|0.95|1.47|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 5 concentrations one month after the third dose.||1.47|0.95|
70972656|NCT01978093|141452156|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 6A is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.29|||||TWO_SIDED|97.5|1.03|1.63|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 6A concentrations one month after the third dose.||1.63|1.03|
70972657|NCT01978093|141452156|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 6B is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.17|||||TWO_SIDED|97.5|0.88|1.55|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 6B concentrations one month after the third dose.||1.55|0.88|
70972658|NCT01978093|141452156|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 7F is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.11|||||TWO_SIDED|97.5|0.91|1.34|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 7F concentrations one month after the third dose.||1.34|0.91|
70972659|NCT01978093|141452156|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 9V is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.25|||||TWO_SIDED|97.5|1.0|1.55|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 9V concentrations one month after the third dose.||1.55|1.00|
70972660|NCT01978093|141452156|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 14 is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.16|||||TWO_SIDED|97.5|0.9|1.5|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 14 concentrations one month after the third dose.||1.50|0.90|
70972661|NCT01978093|141452156|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 18C is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.24|||||TWO_SIDED|97.5|1.01|1.52|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 18C concentrations one month after the third dose.||1.52|1.01|
71094378|NCT03043573|141696616|SUPERIORITY||Mean Difference (Final Values)|2.4595||||0.888|TWO_SIDED|95.0|-32.3472|37.2661|||t-test, 2 sided|||Week 12||37.2661|-32.3472|0.8880
71094379|NCT03043573|141696616|SUPERIORITY||Mean Difference (Final Values)|-0.5119||||0.9773|TWO_SIDED|95.0|-36.5024|35.4785|||t-test, 2 sided|||Week 24||35.4785|-36.5024|0.9773
71094380|NCT03043573|141696616|SUPERIORITY||Mean Difference (Final Values)|15.6667||||0.6173|TWO_SIDED|95.0|-47.0598|78.3931|||t-test, 1 sided|||Week 52||78.3931|-47.0598|0.6173
71094381|NCT03043573|141696617|SUPERIORITY||Mean Difference (Final Values)|1.1302||||0.5454|TWO_SIDED|95.0|-2.5767|4.8371|||t-test, 2 sided|||Baseline||4.8371|-2.5767|0.5454
71094382|NCT03043573|141696617|SUPERIORITY||Mean Difference (Final Values)|2.9618||||0.1212|TWO_SIDED|95.0|-0.8038|6.7275|||t-test, 2 sided|||Week 6||6.7275|-0.8038|0.1212
71094383|NCT03043573|141696617|SUPERIORITY||Mean Difference (Final Values)|1.095||||0.571|TWO_SIDED|95.0|-2.7476|4.9377|||t-test, 2 sided|||Week 12||4.9377|-2.7476|0.5710
71094384|NCT03043573|141696617|SUPERIORITY||Mean Difference (Final Values)|-1.5524||||0.4377|TWO_SIDED|95.0|-5.5256|2.4209|||t-test, 2 sided|||Week 24||2.4209|-5.5256|0.4377
71094385|NCT03043573|141696617|SUPERIORITY||Mean Difference (Final Values)|0.8937||||0.6813|TWO_SIDED|95.0|-3.4439|5.2312|||t-test, 2 sided|||Week 36||5.2312|-3.4439|0.6813
71094386|NCT03043573|141696617|SUPERIORITY||Mean Difference (Final Values)|2.9457||||0.162|TWO_SIDED|95.0|-1.2234|7.1148|||t-test, 2 sided|||||7.1148|-1.2234|0.1620
70972662|NCT01978093|141452156|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 19A is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.16|||||TWO_SIDED|97.5|0.94|1.43|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 19A concentrations one month after the third dose.||1.43|0.94|
70972663|NCT01978093|141452156|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 19F is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.07|||||TWO_SIDED|97.5|0.89|1.29|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 19F concentrations one month after the third dose.||1.29|0.89|
71031896|NCT01015625|141572583|SUPERIORITY|A two-sided significance level of 5% was used.|Cox Proportional Hazard|0.95||||0.89|TWO_SIDED|95.0|0.45|2.02|||Log Rank||From the Cox Proportional hazard model with surgery vs no surgery fitted as a covariate. A hazard ratio \> 1.0 indicates a higher average event rate and a shorter time to local progression for surgery relative to no surgery.|To determine the effect of local therapy (surgery) compared to systemic therapy only in synchronous metastasized breast cancer patients in terms of time from randomization to local progression. Local progression is defined as recurrence in breast with localization mamma, chest wall or axilla. Participants last known to be alive, who did not experience a local progression were censored at their last contact date or at the data cut-off date whichever came first.||2.02|0.45|0.890
71031897|NCT04459585|141572606|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|111.88|||||TWO_SIDED|90.0|77.57|161.35|||||For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.|Statistical comparison was analyzed for Total Dabigatran.||161.35|77.57|
71031898|NCT04459585|141572606|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|112.98|||||TWO_SIDED|90.0|77.2|165.34|||||For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.|Statistical comparison was analyzed for Free Dabigatran.||165.34|77.20|
71031899|NCT04459585|141572607|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|111.37|||||TWO_SIDED|90.0|78.51|157.97|||||For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.|Statistical comparison was analyzed for Total Dabigatran.||157.97|78.51|
71031900|NCT04459585|141572607|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|111.08|||||TWO_SIDED|90.0|77.35|159.51|||||For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.|Statistical comparison was analyzed for Free Dabigatran.||159.51|77.35|
71031901|NCT04459585|141572608|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|112.97|||||TWO_SIDED|90.0|79.38|160.79|||||For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.|Statistical comparison was analyzed for Total Dabigatran.||160.79|79.38|
71031902|NCT04459585|141572608|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|110.72|||||TWO_SIDED|90.0|76.77|159.68|||||For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.|Statistical comparison was analyzed for Free Dabigatran.||159.68|76.77|
71031903|NCT01061866|141572623|NON_INFERIORITY_OR_EQUIVALENCE|p less than or equal to 0.05, repeated measures ANOVA|Mean Difference (Final Values)|0.02|||<|0.02||||||p-value is non-adjusted for multiple comparisons|ANOVA|Was adjusted the degrees of freedom for the averaged test of significance.|The frequency of seizures at the beginning of the study and after treatment with thalidomide was contrasted in the same group patients.|Power=0.02||||<0.02
71031904|NCT00772941|141572624|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Gender. The null hypothesis is that there is no difference between Male and Female in the frequency of Treatment Related Adverse Events."||||<0.001
71031905|NCT00772941|141572625|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Age. The null hypothesis is that there is no difference between \<65 years and \>=65 years in the frequency of Treatment Related Adverse Events."||||<0.001
71094387|NCT03043573|141696618|SUPERIORITY||Mean Difference (Final Values)|0.0319||||0.9813|TWO_SIDED|95.0|-2.6668|2.7305|||t-test, 2 sided|||Baseline||2.7305|-2.6668|0.9813
71094388|NCT03043573|141696618|SUPERIORITY||Mean Difference (Final Values)|-0.0564||||0.9735|TWO_SIDED|95.0|-3.4397|3.3268|||t-test, 2 sided|||Week 6||3.3268|-3.4397|0.9735
71094389|NCT03043573|141696618|SUPERIORITY|Week 12|Mean Difference (Final Values)|1.0611||||0.5164|TWO_SIDED|95.0|-2.1885|4.3107|||t-test, 2 sided|||||4.3107|-2.1885|0.5164
71094390|NCT03043573|141696618|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.197|TWO_SIDED|95.0|-5.0651|1.0651|||t-test, 2 sided|||Week 24||1.0651|-5.0651|0.1970
71094391|NCT03043573|141696618|SUPERIORITY||Mean Difference (Net)|0.362||||0.8342|TWO_SIDED|95.0|-3.0907|3.8146|||t-test, 2 sided|||Week 36||3.8146|-3.0907|0.8342
71094392|NCT03043573|141696618|SUPERIORITY||Mean Difference (Final Values)|1.2667||||0.4717|TWO_SIDED|95.0|-2.2424|4.7758|||t-test, 2 sided|||Week 52||4.7758|-2.2424|0.4717
71094393|NCT03043573|141696619|SUPERIORITY||Mean Difference (Final Values)|-2.9318||||0.513|TWO_SIDED|95.0|-11.8176|5.9539|||t-test, 2 sided|||Baseline||5.9539|-11.8176|0.5130
71094394|NCT03043573|141696619|SUPERIORITY||Mean Difference (Final Values)|0.4835||||0.4835|TWO_SIDED|95.0|-15.2306|7.2967|||t-test, 2 sided|||Week 12||7.2967|-15.2306|0.4835
71094395|NCT03043573|141696619|SUPERIORITY||Mean Difference (Final Values)|-5.156||||0.359|TWO_SIDED|95.0|-16.3357|6.0238|||t-test, 2 sided|||Week 24||6.0238|-16.3357|0.3590
71094396|NCT03043573|141696619|SUPERIORITY||Mean Difference (Final Values)|1.1083||||0.876|TWO_SIDED|95.0|-13.1598|15.3765|||t-test, 2 sided|||Week 52||15.3765|-13.1598|0.8760
71094397|NCT03043573|141696620|SUPERIORITY||Mean Difference (Final Values)|-0.0606||||0.3248|TWO_SIDED|95.0|-0.1841|0.0628|||t-test, 2 sided|||Trails A Baseline||0.0628|-0.1841|0.3248
71094398|NCT03043573|141696620|SUPERIORITY||Mean Difference (Final Values)|-0.6953||||0.3615|TWO_SIDED|95.0|-2.2261|0.8354|||t-test, 2 sided|||Trails A - Week 12||0.8354|-2.2261|0.3615
71094399|NCT03043573|141696620|SUPERIORITY||Mean Difference (Final Values)|0.9917||||0.5046|TWO_SIDED|95.0|-1.9664|3.9498|||t-test, 2 sided|||Trails B - Baseline||3.9498|-1.9664|0.5046
70919862|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Month 36: Global (Aided)||||0.78
71094400|NCT03043573|141696620|SUPERIORITY||Mean Difference (Final Values)|-2.0607||||0.0679|TWO_SIDED|95.0|-4.2821|0.1607|||t-test, 2 sided|||Trails B - Week 12||0.1607|-4.2821|0.0679
71094401|NCT03043573|141696620|SUPERIORITY||Mean Difference (Final Values)|-0.8929||||0.1669|TWO_SIDED|95.0|-2.1825|0.3968|||t-test, 2 sided|||Trails B - Week 24||0.3968|-2.1825|0.1669
71094402|NCT03043573|141696620|SUPERIORITY||Mean Difference (Final Values)|-1.4286||||0.2178|TWO_SIDED|95.0|-3.8115|0.9543|||t-test, 2 sided|||Trails B - Week 52||0.9543|-3.8115|0.2178
70919863|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Month 36: Ease of Communication (Unaided)||||0.50
70919864|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Month 36: Background Noise (Unaided)||||0.48
70919865|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Month 36: Reverberation (Unaided)||||0.64
71094403|NCT03043573|141696621|SUPERIORITY||Mean Difference (Final Values)|1.558||||0.2932|TWO_SIDED|95.0|-1.3747|4.4908|||t-test, 2 sided|||Baseline||4.4908|-1.3747|0.2932
71094404|NCT03043573|141696621|SUPERIORITY||Mean Difference (Final Values)|1.7043||||0.2871|TWO_SIDED|95.0|-1.4659|4.8744|||t-test, 2 sided|||Week 6||4.8744|-1.4659|0.2871
71094405|NCT03043573|141696621|SUPERIORITY||Mean Difference (Final Values)|0.9167||||0.591|TWO_SIDED|95.0|-2.4737|4.307|||t-test, 2 sided|||Week 12||4.3070|-2.4737|0.5910
71094406|NCT03043573|141696621|SUPERIORITY||Mean Difference (Final Values)|-1.0238||||0.6128|TWO_SIDED|95.0|-5.0469|2.9993|||t-test, 2 sided|||||2.9993|-5.0469|0.6128
71094407|NCT03043573|141696621|SUPERIORITY||Mean Difference (Final Values)|1.9276||||0.3326|TWO_SIDED|95.0|-2.0231|5.8783|||t-test, 2 sided|||Week 36||5.8783|-2.0231|0.3326
71094408|NCT03043573|141696621|SUPERIORITY||Mean Difference (Final Values)|2.0741||||0.2935|TWO_SIDED|95.0|-1.8522|6.0004|||t-test, 2 sided|||Week 52||6.0004|-1.8522|0.2935
71094409|NCT01251861|141696625|SUPERIORITY|||||||0.28||||||one-sided|Fisher Exact|||||||0.28
71094410|NCT01251861|141696634|OTHER|The association between PSA response (responder vs non-responder) and Gleason score (\<7, 7 vs. \>7) was evaluated by logistic regression with adjustment for treatment assignment.||||||0.5||||||p-value based on logistic regression with adjustment for treatment assignment|Regression, Logistic|||The association between PSA response (responder vs non-responder) and Gleason score (\<7, 7 vs. \>7) was evaluated by logistic regression with adjustment for treatment assignment.||||0.50
71094411|NCT01251861|141696635|OTHER|The association between PSA response (responder vs non-responder) and prior hormonal therapy (yes vs. no) was evaluated by logistic regression with adjustment for treatment assignment.||||||0.28||||||p-value based on logistic regression with adjustment for treatment assignment|Regression, Logistic|||The association between PSA response (responder vs non-responder) and prior hormonal therapy (yes vs. no) was evaluated by logistic regression with adjustment for treatment assignment.||||0.28
71094412|NCT01991314|141696646|NON_INFERIORITY_OR_EQUIVALENCE|We calculated, on the premise that there is non-inferiority between adolescent and adult groups in the difference in increase of mean haemoglobin levels of 0.35g/dL, with estimated standard deviation 0.7g/dL following treatment, that 45 patients in each group would be required, derived using power 80% power, 1-sided significance level 0.05 and R 0.5 for the covariate; this calculation took into account planned ANCOVA methodology and 20% patients who might be lost to follow up or withdraw.|Mean Difference (Net)|0.08||||0.23|TWO_SIDED|||||To test the hypothesis of non-inferiority with maximal statistical power, ANCOVA (one-tailed P\<0.05) was employed to compare the change in mean haemoglobin levels between adults and adolescents after accounting for necessary covariates|ANCOVA|||||||0.23
71094413|NCT01991314|141696647|SUPERIORITY_OR_OTHER||difference in proportions|3.6|||<|0.05|TWO_SIDED||||||Fisher Exact|Fisher's exact test was used to compare proportions (expressed as percentages) of total number of participants in each group who were iron intolerant||Chi squared test or Fisher's exact test, as appropriate.||||<0.05
71094414|NCT01991314|141696648|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.0||||0.96|TWO_SIDED||||||t-test, 2 sided|||Unpaired Students t test||||0.96
71094415|NCT01991314|141696649|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5||||0.49|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U test||||0.49
71094416|NCT01991314|141696650|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.85|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Mann Whitney U test||||0.85
70972664|NCT01978093|141452156|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 23F is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.18|||||TWO_SIDED|97.5|0.91|1.53|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 23F concentrations one month after the third dose.||1.53|0.91|
71031906|NCT00772941|141572626|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Chronic obstructive pulmonary disease as a complication. The null hypothesis is that there is no difference between Varenicline with and without Chronic obstructive pulmonary disease as a complication in the frequency of Treatment Related Adverse Events."||||<0.001
71094417|NCT01991314|141696651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.69|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Mann Whitney U test||||0.69
71094418|NCT01991314|141696652|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.9|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U test||||<0.0001
71094419|NCT00879359|141696653|SUPERIORITY_OR_OTHER||Hazard Ratio, log|92.0|||||TWO_SIDED|95.0|64.0|99.0||||||||99|64|
71094420|NCT00970944|141696656|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||Mixed Models Analysis|||We will have 80% power to detect a one point difference in DRS score between the groups across the four week treatment window. With this sample size, we will be able to detect any unforeseen adverse events that have a prevalence of at least 2.5% in each group with 90% probability. With 92 patients per group we will be able to estimate the rate of adverse events to within ±10%.||||0.045
71094421|NCT00970944|141696657|SUPERIORITY_OR_OTHER||Slope|-0.24|STANDARD_ERROR_OF_MEAN|0.088||0.007||95.0|-0.41|-0.07||The final analysis used a significance level of 0.045.|Mixed Models Analysis|Final analysis adjusted for early v. late enrollment relative to date of injury, baseline CRS-R rating category (MCS vs. VS), and site.||The planned sample size of 184 patients provided 80% power to detect a difference between the AH and placebo in the rate of Disability Rating Scale (DRS) score change of 0.3 points/week (1.22 DRS point mean difference by the end of the 4-week treatment interval). Two blinded interim analyses were conducted at 60 and 120 patients recruited using the O'Brien-Fleming boundary, with alpha levels of 0.0005 and 0.014. The final analysis used an alpha level of 0.045.||-0.07|-0.41|0.007
71094422|NCT03915067|141696664|SUPERIORITY||Rate Difference|65.8|||<|0.0001|TWO_SIDED|95.0|51.5|80.1||P-value derived from CMH model stratified by investigator site and C-APPS at Day 1.|Cochran-Mantel-Haenszel|||||80.1|51.5|<0.0001
71094423|NCT03915067|141696664|SUPERIORITY||Rate Difference|76.2|||<|0.0001|TWO_SIDED|95.0|63.6|88.9||P-value derived from CMH model stratified by investigator site and C-APPS at Day 1.|Cochran-Mantel-Haenszel|||||88.9|63.6|<0.0001
71094424|NCT03915067|141696687|SUPERIORITY||Rate Difference|57.9|||<|0.0001|TWO_SIDED|95.0|42.3|73.5||P-value was derived from CMH model stratified by investigator site and P-APPS at Day 1.|Cochran-Mantel-Haenszel|||||73.5|42.3|<0.0001
71094425|NCT03915067|141696687|SUPERIORITY||Rate Difference|70.2|||<|0.0001|TWO_SIDED|95.0|56.4|84.1||P-value derived from CMH model stratified by investigator site and P-APPS at Day 1.|Cochran-Mantel-Haenszel|||||84.1|56.4|<0.0001
70919866|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.041|||||||Wilcoxon (Mann-Whitney)|||Month 36: Aversiveness (Unaided)||||0.041
70919867|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||Month 36: Global (Unaided)||||0.89
70919868|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Month 36: Ease of Communication (Benefit)||||0.14
71031907|NCT00772941|141572627|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was concomitant drugs. The null hypothesis is that there is no difference between Varenicline with and without concomitant drugs in the frequency of Treatment Related Adverse Events."||||<0.001
71031908|NCT00772941|141572628|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was concomitant therapies. The null hypothesis is that there is no difference between Varenicline with and without concomitant therapies in the frequency of Treatment Related Adverse Events."||||<0.001
70919869|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Month 36: Background Noise (Benefit)||||0.48
70919870|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Month 36: Reverberation (Benefit)||||0.23
70919871|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Month 36: Aversiveness (Benefit)||||0.57
70919872|NCT01796236|141330208|SUPERIORITY_OR_OTHER|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Month 36: Global (Benefit)||||0.21
70919873|NCT01796236|141330209|SUPERIORITY_OR_OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||Sound Processor Usage: Week 6||||0.46
70919874|NCT01796236|141330209|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Use of Sound Processor: Week 12||||0.75
70919875|NCT01796236|141330209|SUPERIORITY_OR_OTHER|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||Use of Sound Processor: Week 24||||0.83
70919876|NCT01796236|141330209|SUPERIORITY_OR_OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Use of Sound Processor: Month 12||||0.52
70919877|NCT01796236|141330209|SUPERIORITY_OR_OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Use of Sound Processor: Month 24||||0.67
70919878|NCT01796236|141330209|SUPERIORITY_OR_OTHER|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Use of Sound Processor: Month 36||||0.71
71094426|NCT01033942|141696688|SUPERIORITY_OR_OTHER|||||||0.6983||||||The p-value is for the difference in treatment (TX) groups overall. The interaction between TX group and study time that tests whether the TX groups differed over time could not be tested due to small no. of subjects that missed visits during study.|Chi-squared|||||||0.6983
71094427|NCT01033942|141696689|SUPERIORITY_OR_OTHER|||||||0.8722|TWO_SIDED||||||Fisher Exact|||||||0.8722
71094428|NCT01033942|141696690|SUPERIORITY_OR_OTHER|||||||0.6921||||||Not all subjects answered every question.|Fisher Exact|||||||0.6921
71094429|NCT01033942|141696691|SUPERIORITY_OR_OTHER|||||||0.4655||||||Not all participants answered every question|Fisher Exact|||||||0.4655
71094430|NCT01033942|141696692|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED|||||Not all participants answered every question|Fisher Exact|||||||0.9999
70972665|NCT01978093|141452157|NON_INFERIORITY|Lower limit of the two-sided standardized asymptotic 97.5% CI on the difference (HibCY group minus the PedHIB group) in the percentage of subjects with anti-HAV concentrations ≥15 mIU/mL is to be≥-10% (clinical limit for non-inferiority).|Difference in percentage of subjects|0.0|||||TWO_SIDED|97.5|-3.76|3.91|||Group difference in proportions||To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix \& Prevnar13 post dose 4),Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|Difference between HibCY and PedHIB groups in percentage of subjects with anti-HAV concentrations equal to or above the cut-off value of 15 mIU/mL one month after the second Havrix dose.||3.91|-3.76|
70972666|NCT01978093|141452158|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 1 is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.25|||||TWO_SIDED|97.5|1.04|1.51|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 1 concentrations one month after the fourth dose||1.51|1.04|
70972667|NCT01978093|141452158|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 3 is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.01|||||TWO_SIDED|97.5|0.83|1.24|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 3 concentrations one month after the fourth dose||1.24|0.83|
70972668|NCT01978093|141452158|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 4 is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.1|||||TWO_SIDED|97.5|0.92|1.31|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 4 concentrations one month after the fourth dose||1.31|0.92|
70972669|NCT01978093|141452158|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 5 is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.06|||||TWO_SIDED|97.5|0.87|1.28|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 5 concentrations one month after the fourth dose||1.28|0.87|
70972670|NCT01978093|141452158|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 6A is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.21|||||TWO_SIDED|97.5|1.01|1.44|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 6A concentrations one month after the fourth dose||1.44|1.01|
71008726|NCT02055976|141525247|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-39.657|STANDARD_ERROR_OF_MEAN|7.29|<|0.001|TWO_SIDED|95.0|-54.136|-25.178|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-25.178|-54.136|<0.001
71008727|NCT02055976|141525247|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.681|STANDARD_ERROR_OF_MEAN|13.601||0.366|TWO_SIDED|95.0|-31.713|22.35|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||22.350|-31.713|0.366
71008728|NCT02055976|141525247|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.227|STANDARD_ERROR_OF_MEAN|13.586||0.773|TWO_SIDED|95.0|-16.774|37.228|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||37.228|-16.774|0.773
71094431|NCT01033942|141696693|SUPERIORITY_OR_OTHER|||||||0.2297|TWO_SIDED|||||Not all participants answered every question|Fisher Exact|||||||0.2297
71094432|NCT01033942|141696694|SUPERIORITY_OR_OTHER|||||||0.1886||||||Not all participants answered every question|Fisher Exact|||||||0.1886
71094433|NCT01033942|141696695|SUPERIORITY_OR_OTHER|||||||0.1908|||||||Fisher Exact|||||||0.1908
71094434|NCT01033942|141696696|SUPERIORITY_OR_OTHER|||||||0.224||||||Not all participants answered every question|Fisher Exact|||||||0.2240
71094435|NCT01033942|141696697|SUPERIORITY_OR_OTHER|||||||0.1538||||||Not all participants answered every question|Fisher Exact|||||||0.1538
71094436|NCT01033942|141696698|SUPERIORITY_OR_OTHER|||||||0.2151||||||Not all participants answered every question|Fisher Exact|||||||0.2151
71094437|NCT01033942|141696699|SUPERIORITY_OR_OTHER|||||||0.2809||||||Not all participants answered every question|Fisher Exact|||||||0.2809
71094438|NCT01033942|141696700|SUPERIORITY_OR_OTHER|||||||0.185||||||Not all participants answered every question|Fisher Exact|||||||0.1850
71094439|NCT01033942|141696701|SUPERIORITY_OR_OTHER|||||||0.2366||||||Not all participants answered every question|Fisher Exact|||||||0.2366
70972671|NCT01978093|141452158|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 6B is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.13|||||TWO_SIDED|97.5|0.94|1.36|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 6B concentrations one month after the fourth dose||1.36|0.94|
70972672|NCT01978093|141452158|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 7F is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.09|||||TWO_SIDED|97.5|0.93|1.29|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 7F concentrations one month after the fourth dose||1.29|0.93|
70972673|NCT01978093|141452158|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 9V is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.12|||||TWO_SIDED|97.5|0.94|1.33|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 9V concentrations one month after the fourth dose||1.33|0.94|
70972674|NCT01978093|141452158|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 14 is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.16|||||TWO_SIDED|97.5|0.96|1.41|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 14 concentrations one month after the fourth dose||1.41|0.96|
71094440|NCT01033942|141696702|SUPERIORITY_OR_OTHER|||||||0.4089||||||Not all subjects answered every question.|Fisher Exact|||||||0.4089
71094441|NCT01033942|141696703|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
71094442|NCT01033942|141696704|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
71094443|NCT01033942|141696705|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
71094444|NCT01033942|141696706|SUPERIORITY_OR_OTHER|||||||0.7007|||||||Fisher Exact|||||||0.7007
71094445|NCT01033942|141696707|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
71094446|NCT01033942|141696708|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
71094447|NCT01033942|141696709|SUPERIORITY_OR_OTHER|||||||0.8934|||||||Chi-squared|||||||0.8934
71094448|NCT01033942|141696710|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
71094449|NCT01033942|141696711|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
71094450|NCT01033942|141696712|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
71094451|NCT01033942|141696713|SUPERIORITY_OR_OTHER|||||||0.4003|||||||Fisher Exact|||||||0.4003
71094452|NCT01033942|141696714|SUPERIORITY_OR_OTHER|||||||0.6462|||||||Fisher Exact|||||||0.6462
71094453|NCT01033942|141696715|SUPERIORITY_OR_OTHER|||||||0.8505|||||||Chi-squared|||||||0.8505
71094454|NCT01033942|141696723|SUPERIORITY_OR_OTHER|||||||0.7434|TWO_SIDED||||||Chi-squared|||||||0.7434
71094455|NCT01033942|141696724|SUPERIORITY_OR_OTHER|||||||0.6153|TWO_SIDED||||||Chi-squared|||||||0.6153
71094456|NCT01033942|141696725|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Chi-squared|||||||0.2000
71094457|NCT01033942|141696726|SUPERIORITY_OR_OTHER|||||||0.5265|TWO_SIDED||||||Chi-squared|||||||0.5265
71094458|NCT01033942|141696727|SUPERIORITY_OR_OTHER|||||||0.2559|TWO_SIDED||||||Chi-squared|||||||0.2559
71094459|NCT01033942|141696728|SUPERIORITY_OR_OTHER|||||||0.3846|TWO_SIDED||||||Chi-squared|||||||0.3846
71094460|NCT01033942|141696729|SUPERIORITY_OR_OTHER|||||||0.5133|TWO_SIDED||||||Chi-squared|||||||0.5133
71094461|NCT01033942|141696730|SUPERIORITY_OR_OTHER|||||||0.1661|TWO_SIDED||||||Chi-squared|||||||0.1661
71094462|NCT01033942|141696731|SUPERIORITY_OR_OTHER|||||||0.0729|TWO_SIDED||||||Chi-squared|||||||0.0729
71094463|NCT01033942|141696732|SUPERIORITY_OR_OTHER|||||||0.1912|TWO_SIDED||||||Chi-squared|||||||0.1912
71094464|NCT01033942|141696733|SUPERIORITY_OR_OTHER|||||||0.2829|TWO_SIDED||||||Chi-squared|||||||0.2829
71094465|NCT01033942|141696734|SUPERIORITY_OR_OTHER|||||||0.2685|TWO_SIDED||||||Chi-squared|||||||0.2685
71094466|NCT01033942|141696735|SUPERIORITY_OR_OTHER|||||||0.2342|TWO_SIDED||||||Chi-squared|||||||0.2342
71094467|NCT01033942|141696736|SUPERIORITY_OR_OTHER|||||||0.7314|TWO_SIDED||||||Fisher Exact|||||||0.7314
71094468|NCT01033942|141696737|SUPERIORITY_OR_OTHER|||||||0.377|||||||Fisher Exact|||||||0.3770
71094469|NCT01033942|141696738|SUPERIORITY_OR_OTHER|||||||0.7004|||||||Fisher Exact|||||||0.7004
71094470|NCT01033942|141696739|SUPERIORITY_OR_OTHER|||||||0.4668|||||||Fisher Exact|||||||0.4668
71094471|NCT01033942|141696740|SUPERIORITY_OR_OTHER|||||||0.7573|||||||Fisher Exact|||||||0.7573
71094472|NCT01033942|141696741|SUPERIORITY_OR_OTHER|||||||0.0356|||||||Fisher Exact|||||||0.0356
71094473|NCT01033942|141696742|SUPERIORITY_OR_OTHER|||||||0.3176|||||||Fisher Exact|||||||0.3176
71094474|NCT01033942|141696743|SUPERIORITY_OR_OTHER|||||||0.1348|||||||Fisher Exact|||||||0.1348
71094475|NCT01033942|141696744|SUPERIORITY_OR_OTHER|||||||0.042|||||||Fisher Exact|||||||0.0420
71094476|NCT01033942|141696745|SUPERIORITY_OR_OTHER|||||||0.4906|||||||Fisher Exact|||||||0.4906
71094477|NCT01033942|141696746|SUPERIORITY_OR_OTHER|||||||0.0544|||||||Fisher Exact|||||||0.0544
71094478|NCT01033942|141696747|SUPERIORITY_OR_OTHER|||||||0.5645|||||||Fisher Exact|||||||0.5645
71094479|NCT01033942|141696748|SUPERIORITY_OR_OTHER|||||||0.7847|||||||Fisher Exact|||||||0.7847
71094480|NCT01033942|141696749|SUPERIORITY_OR_OTHER|||||||0.0288|||||||Fisher Exact|||||||0.0288
71008729|NCT02055976|141525247|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.646|STANDARD_ERROR_OF_MEAN|13.362||0.422|TWO_SIDED|95.0|-29.206|23.915|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||23.915|-29.206|0.422
71094481|NCT01033942|141696750|SUPERIORITY_OR_OTHER|||||||0.0945|||||||Fisher Exact|||||||0.0945
71094482|NCT01033942|141696751|SUPERIORITY_OR_OTHER|||||||0.3884|||||||Fisher Exact|||||||0.3884
70919879|NCT01796236|141330211|SUPERIORITY_OR_OTHER|||||||0.91|||||||Mantel Haenszel|||Baseline: Smoking and Wet Snuff habits||||0.91
70919880|NCT01796236|141330211|SUPERIORITY_OR_OTHER|||||||0.7|||||||Mantel Haenszel|||Week 3: Smoking and Wet Snuff habits||||0.70
70919881|NCT01796236|141330211|SUPERIORITY_OR_OTHER|||||||0.95|||||||Mantel Haenszel|||Week 12: Smoking and Wet Snuff habits||||0.95
70919882|NCT01796236|141330211|SUPERIORITY_OR_OTHER|||||||0.22|||||||Mantel Haenszel|||Month 12: Smoking and Wet Snuff habits||||0.22
70919883|NCT01796236|141330211|SUPERIORITY_OR_OTHER|||||||0.19|||||||Mantel Haenszel|||Month 24: Smoking and Wet Snuff habits||||0.19
70919884|NCT01796236|141330211|SUPERIORITY_OR_OTHER|||||||0.45|||||||Mantel Haenszel|||Month 36: Smoking and Wet Snuff habits||||0.45
70919885|NCT01796236|141330212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.989|TWO_SIDED|95.0|||||Log Rank|||Loss of Implant (safety population)||||0.989
70919886|NCT00546754|141330214|SUPERIORITY_OR_OTHER_LEGACY|||||||0.153||95.0|||||ANOVA|||||||0.153
70919887|NCT00546754|141330215|SUPERIORITY_OR_OTHER_LEGACY|||||||0.343||95.0|||||ANOVA|||||||0.343
70919888|NCT00546754|141330216|SUPERIORITY_OR_OTHER_LEGACY|||||||0.118||95.0|||||Fisher Exact|||||||0.118
70919889|NCT00546754|141330217|SUPERIORITY_OR_OTHER_LEGACY|||||||0.395||95.0|||||ANOVA|||||||0.395
70919890|NCT00546754|141330218|SUPERIORITY_OR_OTHER_LEGACY|||||||0.662||95.0|||||Fisher Exact|||||||0.662
70919891|NCT00546754|141330219|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||Log Rank|||||||0.020
70919892|NCT00546754|141330220|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71094483|NCT01033942|141696752|SUPERIORITY_OR_OTHER|||||||0.2235|||||||Fisher Exact|||||||0.2235
70919893|NCT00546754|141330221|SUPERIORITY_OR_OTHER_LEGACY|||||||0.935||95.0|||||ANOVA|||||||0.935
70919894|NCT00546754|141330222|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANOVA|||||||<0.001
70919895|NCT00546754|141330223|SUPERIORITY_OR_OTHER_LEGACY|||||||0.899||95.0|||||ANOVA|||||||0.899
70919896|NCT00546754|141330224|SUPERIORITY_OR_OTHER_LEGACY|||||||0.218||95.0|||||ANOVA|||||||0.218
70919897|NCT00546754|141330225|SUPERIORITY_OR_OTHER_LEGACY|||||||0.386||95.0|||||ANOVA|||||||0.386
70919898|NCT00546754|141330226|SUPERIORITY_OR_OTHER_LEGACY|||||||0.725||95.0|||||ANOVA|||||||0.725
70919899|NCT00311363|141330234|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.353||||0.0158||95.0|0.2|0.8||Model included terms for treatment group, randomization IRLS score (Week 24), and pooled study site|Regression, Logistic|||||0.8|0.2|0.0158
70919900|NCT03830866|141330267|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.174|TWO_SIDED|95.0|0.65|1.08|||Log Rank|||||1.08|0.65|0.174
70919901|NCT03830866|141330268|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.203|TWO_SIDED|95.0|0.64|1.1|||Log Rank|||||1.10|0.64|0.203
70919902|NCT03830866|141330270|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.091|TWO_SIDED|95.0|0.6|1.04|||Log Rank|||||1.04|0.60|0.091
70919903|NCT03830866|141330271|SUPERIORITY||Odds Ratio (OR)|1.15||||0.465|TWO_SIDED|95.0|0.794|1.657|||Regression, Logistic|||||1.657|0.794|0.465
70919904|NCT03830866|141330272|SUPERIORITY||Odds Ratio (OR)|1.11||||0.469|TWO_SIDED|95.0|0.833|1.487|||Regression, Logistic|||||1.487|0.833|0.469
70919905|NCT00716859|141330286|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If lower limit of 95% Confidence Interval (CI) for treatment difference is above non-inferiority margin, then non-inferiority concluded. If lower limit of 95% CI for treatment difference is above non-inferiority margin and above zero, then superiority concluded. The difference and 95% CI of the difference in IOP reduction (Week 12) was computed from an analysis of covariance (ANCOVA) model with treatment and baseline diagnosis as factors and baseline IOP as covariate.|Mean Difference (Net)|1.46|||||TWO_SIDED|95.0|-0.81|3.74||||||Null hypothesis: latanoprost inferior to timolol (0.5 percent \[%\] optionally 0.25% for participants younger than 3 years). Power calculation: assuming common standard deviation (7 mmHg), 110 participants have 84% power to demonstrate latanoprost not inferior to timolol within 3 mmHg margin, assuming latanoprost has 1 mmHg reduction more than timolol in mean change from baseline IOP.||3.74|-0.81|
70919906|NCT00716859|141330287|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.68|||||TWO_SIDED|95.0|-1.66|3.02||||||||3.02|-1.66|
70919907|NCT00716859|141330288|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.62|||||TWO_SIDED|95.0|-1.0|4.25||||||||4.25|-1.00|
70919908|NCT00716859|141330289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.4085|||||TWO_SIDED|95.0|-1.1|2.67||||||||2.67|-1.10|
70919909|NCT00716859|141330294|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3315|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value from a Cochran-Mantel-Haenszel chi-square test stratified by baseline diagnosis (PCG vs non-PCG).||||||0.3315
70919910|NCT01551355|141330314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|||<|0.001|TWO_SIDED|95.0|1.64|6.16|||t-test, 2 sided|The intervention was evaluated using generalized estimating equation models, controlling for cluster effect, sex, age, weight, and education level.||||6.16|1.64|<.001
70919911|NCT01551355|141330315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.08|||<|0.001|TWO_SIDED|95.0|2.03|6.12|||t-test, 2 sided|||||6.12|2.03|<.001
70919912|NCT01551355|141330316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.36|||=|0.06|TWO_SIDED|95.0|-0.29|11.01|||t-test, 2 sided|||||11.01|-0.29|=.06
70919913|NCT02918071|141330326|OTHER||percentage|97.4|||||TWO_SIDED|95.0|92.63|99.46|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12)|Percentage of patients successfully administered benralizumab with an AI at home (Week 12)|||99.46|92.63|
71094484|NCT01033942|141696753|SUPERIORITY_OR_OTHER|||||||0.0467|||||||Fisher Exact|||||||0.0467
71094485|NCT01033942|141696754|SUPERIORITY_OR_OTHER|||||||0.6331|||||||Fisher Exact|||||||0.6331
71094486|NCT01033942|141696755|SUPERIORITY_OR_OTHER|||||||0.0948|||||||Fisher Exact|||||||0.0948
71094487|NCT01033942|141696756|SUPERIORITY_OR_OTHER|||||||0.5826|||||||Fisher Exact|||||||0.5826
70972675|NCT01978093|141452158|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 18C is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.14|||||TWO_SIDED|97.5|0.97|1.35|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 18C concentrations one month after the fourth dose||1.35|0.97|
70972676|NCT01978093|141452158|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 19A is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.09|||||TWO_SIDED|97.5|0.9|1.31|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 19A concentrations one month after the fourth dose||1.31|0.90|
70972677|NCT01978093|141452158|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB Group) for antibodies to S. pneumoniae serotype 19F is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.12|||||TWO_SIDED|97.5|0.95|1.34|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 19F concentrations one month after the fourth dose||1.34|0.95|
70972678|NCT01978093|141452158|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 23F is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.22|||||TWO_SIDED|97.5|1.0|1.5|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 23F concentrations one month after the fourth dose||1.50|1.00|
70972679|NCT02469090|141452173|SUPERIORITY||LS mean differnce|-7.6|STANDARD_ERROR_OF_MEAN|1.96||0.0002|TWO_SIDED|95.0|-11.5|-3.7||The null-hypothesis to be tested was: H0: APL-130277 is the same as placebo in its effect on the motor function against the 2-sided alternative: H1: Either of the treatment groups is superior to the other in its effect on the motor function.|LS mean difference|To control the family-wise type I error rate, the primary and secondary end points were tested in hierarchical order in the order presented||Mixed effects model for repeated measures (MMRM) was used to estimate the treatment difference(APL-130277-placebo) Observed change from pre-dose MDS-UPDRS Part III score values after 30 minutes were response values. Treatment group, visit and the interaction between the treatment group and visit were fixed factors. Change from pre-dose in MDS-UPDRS Part III score after 30 minutes at the last TV at which the randomized dose was given up through TV6 was used as a covariate||-3.7|-11.5|0.0002
70972680|NCT02469090|141452174|SUPERIORITY||Adjusted odds ratio|2.81||||0.0426|TWO_SIDED|95.0|1.036|7.644|||Adjusted Odds Ratio|||"This was analyzed using a generalized linear mixed model (with logit link function) for binomial data. The model included the observed outcomes as the response values, with treatment group, visit, and the interaction between treatment group and visit as fixed factors and the ON/OFF assessment at the last open-label titration visit at which the randomized dose was given as a covariate."||7.644|1.036|0.0426
71031909|NCT00772941|141572629|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Weight at Baseline. The null hypothesis is that there is no association between Weight at Baseline and the frequency of Treatment Related Adverse Events."||||<0.001
71031910|NCT00772941|141572629|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Armitage|||"The risk factor tested was Weight at Baseline. The null hypothesis is that there is no linear trend in the frequency of Treatment Related Adverse Events across increasing levels of Weight at Baseline."||||<0.001
71094488|NCT01033942|141696757|SUPERIORITY_OR_OTHER|||||||0.0087|||||||Fisher Exact|||||||0.0087
71031911|NCT00772941|141572630|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Tobacco consumption per day. The null hypothesis is that there is no association between Tobacco consumption per day and the efficacy of Varenicline."||||<0.001
71031912|NCT00772941|141572630|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Armitage|||"The risk factor tested was Tobacco consumption per day. The null hypothesis is that there is no linear trend in the efficacy of Varenicline across increasing levels of tobacco consumption per day."||||<0.001
71031913|NCT00772941|141572631|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was prolonged administration after 12 weeks. The null hypothesis is that there is no difference between administration prolonged after 12 weeks and administration not prolonged after 12 weeks in the efficacy of Varenicline."||||<0.001
71031914|NCT00772941|141572632|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was antipsychotics as a concomitant drug. The null hypothesis is that there is no difference between Varenicline with and without antipsychotics as a concomitant drug in the efficacy of Varenicline."||||<0.001
71094489|NCT01033942|141696758|SUPERIORITY_OR_OTHER|||||||0.1934|||||||Fisher Exact|||||||0.1934
71094490|NCT01033942|141696759|SUPERIORITY_OR_OTHER|||||||0.2146|||||||Fisher Exact|||||||0.2146
71094491|NCT01033942|141696760|SUPERIORITY_OR_OTHER|||||||0.5317|||||||Fisher Exact|||||||0.5317
71094492|NCT01033942|141696761|SUPERIORITY_OR_OTHER|||||||0.1733|||||||Fisher Exact|||||||0.1733
71094493|NCT01033942|141696762|SUPERIORITY_OR_OTHER|||||||0.1747|||||||Fisher Exact|||||||0.1747
71094494|NCT01033942|141696763|SUPERIORITY_OR_OTHER|||||||0.1203|||||||Fisher Exact|||||||0.1203
71094495|NCT01033942|141696764|SUPERIORITY_OR_OTHER|||||||0.8243|||||||Fisher Exact|||||||0.8243
71094496|NCT01033942|141696765|SUPERIORITY_OR_OTHER|||||||0.6202|||||||Fisher Exact|||||||0.6202
70972681|NCT02469090|141452175|SUPERIORITY||Adjusted odds ratio|2.8||||0.0501|TWO_SIDED|95.0|1.0|7.84||The hierarchical testing stopped at this endpoint due to non-significant result. P-values for endpoints after this endpoint have not been presented and the confidence interval presented are unadjusted for multiplicity.|Adjusted odds ratio|||"This was analyzed using a generalized linear mixed model (with logit link function) for binomial data. The model included the observed outcomes as the response values, with treatment group, visit, and the interaction between treatment group and visit as fixed factors and the ON/OFF assessment at the last open-label titration visit at which the randomized dose was given as a covariate."||7.84|1.00|0.0501
70972682|NCT02469090|141452178|SUPERIORITY||LS mean difference|-1.1|||||TWO_SIDED|95.0|-3.159|0.959||||||||0.959|-3.159|
70972683|NCT02469090|141452179|SUPERIORITY||LS mean difference|47.6|||||TWO_SIDED|95.0|28.84|66.36||||||||66.36|28.84|
70972684|NCT02469090|141452180|SUPERIORITY||LS mean difference|1.979|||||TWO_SIDED|95.0|-2.162|6.12||||||||6.120|-2.162|
70972685|NCT02469090|141452181|SUPERIORITY||LS mean difference|-3.4|||||TWO_SIDED|95.0|-6.7|-0.2||||||||-0.2|-6.7|
70972686|NCT02469090|141452182|SUPERIORITY||Hazard ratio|3.4|||||TWO_SIDED|95.0|1.99|5.69||||||Median Time to effect for APL-130277 versus placebo patients||5.69|1.99|
71031915|NCT00834756|141572654|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|96.0||||||90.0|87.96|104.78|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.78|87.96|
70972687|NCT02163434|141452183|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
70972688|NCT02163434|141452184|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|||||||0.005
71094497|NCT01033942|141696766|SUPERIORITY_OR_OTHER|||||||0.8351|||||||Fisher Exact|||||||0.8351
70972689|NCT02163434|141452185|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
70972690|NCT02163434|141452187|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
70972691|NCT02163434|141452188|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|||||||0.06
70972692|NCT04283123|141452194|OTHER|Wilcoxon-signed rank test to compare differences from pretest to posttest for the treatment group. The standardized effect size was interpreted using Cohen's criteria.|Cohen's d|0.41|||||TWO_SIDED||||||||Wilcoxon-signed rank test to compare differences from pretest to posttest for the treatment group. The standardized effect size was interpreted using Cohen's criteria.|||||
70972693|NCT04283123|141452194|OTHER|Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria.|Cohen's d|0.45|||||TWO_SIDED||||||||Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria.|||||
70972694|NCT04283123|141452195|OTHER|Wilcoxon-signed rank test to compare differences from pretest to posttest for the treatment group. The standardized effect size was interpreted using Cohen's criteria.|Cohen's d|0.48|||||TWO_SIDED||||||||Wilcoxon-signed rank test to compare differences from pretest to posttest for the treatment group. The standardized effect size was interpreted using Cohen's criteria.|||||
70972695|NCT04283123|141452195|OTHER|Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria.|Cohen's d|0.32|||||TWO_SIDED||||||||Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria.|||||
70972696|NCT04283123|141452196|OTHER|Wilcoxon-signed rank test to compare differences from pretest to posttest for the treatment group. The standardized effect size was interpreted using Cohen's criteria.|Cohen's d|0.6|||||TWO_SIDED||||||||Wilcoxon-signed rank test to compare differences from pretest to posttest for the treatment group. The standardized effect size was interpreted using Cohen's criteria.|||||
70972697|NCT04283123|141452196|OTHER|Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria.|Cohen's d|0.12|||||TWO_SIDED||||||||Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria.|||||
70972698|NCT01415752|141452203|SUPERIORITY|||||||0.25||||||one-sided stratified log-rank test|Log Rank|one-sided stratified log-rank test||||||0.25
70972699|NCT01415752|141452204|SUPERIORITY|||||||0.178||||||one-sided stratified log-rank test|Log Rank|one-sided stratified log-rank test||||||0.178
70972700|NCT03066102|141452236|OTHER|||||||0.227||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||The effects of muscle fatigue on reposition error of scapular elevation. Muscle fatigue would increase reposition error during scapular elevation. One-way repeated measures analysis of variance.||||0.227
70972701|NCT03066102|141452236|OTHER|||||||0.764||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||The effects of muscle fatigue on reposition error of scapular protraction. Muscle fatigue would increase reposition error during scapular protraction. One-way repeated measures analysis of variance.||||0.764
70972702|NCT03066102|141452237|OTHER|||||||0.413||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of upper trapezius during scapular elevation.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."||||0.413
70972703|NCT03066102|141452237|OTHER|||||||0.984||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of lower trapezius during scapular elevation.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."||||0.984
71031916|NCT00834756|141572655|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|98.63||||||90.0|92.34|105.35|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.35|92.34|
71094498|NCT01033942|141696767|SUPERIORITY_OR_OTHER|||||||0.0484|||||||Fisher Exact|||||||0.0484
71094499|NCT01033942|141696768|SUPERIORITY_OR_OTHER|||||||0.4207|||||||Fisher Exact|||||||0.4207
71094500|NCT01033942|141696769|SUPERIORITY_OR_OTHER|||||||0.2187|||||||Fisher Exact|||||||0.2187
71094501|NCT01033942|141696770|SUPERIORITY_OR_OTHER|||||||0.5369|||||||Fisher Exact|||||||0.5369
71094502|NCT01033942|141696771|SUPERIORITY_OR_OTHER|||||||0.1524|||||||Fisher Exact|||||||0.1524
71094503|NCT01033942|141696772|SUPERIORITY_OR_OTHER|||||||0.47|||||||Fisher Exact|||||||0.4700
71094504|NCT01033942|141696773|SUPERIORITY_OR_OTHER|||||||0.4686|||||||Fisher Exact|||||||0.4686
71094505|NCT01033942|141696774|SUPERIORITY_OR_OTHER|||||||0.3791|||||||Fisher Exact|||||||0.3791
71094506|NCT01033942|141696775|SUPERIORITY_OR_OTHER|||||||0.7374|||||||Fisher Exact|||||||0.7374
71094507|NCT01033942|141696776|SUPERIORITY_OR_OTHER|||||||0.9363|||||||Fisher Exact|||||||0.9363
71094508|NCT01033942|141696777|SUPERIORITY_OR_OTHER|||||||0.6267|||||||Fisher Exact|||||||0.6267
71094509|NCT01033942|141696778|SUPERIORITY_OR_OTHER|||||||0.6434|TWO_SIDED||||||Fisher Exact|||||||0.6434
71094510|NCT01033942|141696779|SUPERIORITY_OR_OTHER|||||||0.8582|TWO_SIDED||||||Fisher Exact|||||||0.8582
71094511|NCT01033942|141696780|SUPERIORITY_OR_OTHER|||||||0.5778|TWO_SIDED||||||Fisher Exact|||||||0.5778
71094512|NCT01033942|141696781|SUPERIORITY_OR_OTHER|||||||0.9881|TWO_SIDED||||||Fisher Exact|||||||0.9881
70919914|NCT02918071|141330326|OTHER||Percentage|96.6|||||TWO_SIDED|95.0|91.41|99.05|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 16)|Percentage of patients who successfully administered benralizumab with an AI at home (Week 16)|||99.05|91.41|
70919915|NCT02918071|141330326|OTHER||Percentage|93.1|||||TWO_SIDED|95.0|86.86|96.98|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12 and 16)|Percentage of patients who successfully administered benralizumab with an AI at home (Week 12 and 16)|||96.98|86.86|
71094513|NCT01033942|141696782|SUPERIORITY_OR_OTHER|||||||0.9771|TWO_SIDED||||||Fisher Exact|||||||0.9771
71094514|NCT01033942|141696783|SUPERIORITY_OR_OTHER|||||||0.2301|TWO_SIDED||||||Fisher Exact|||||||0.2301
71094515|NCT02260986|141696800|SUPERIORITY||difference in percentages|26.3|||<|0.0001|TWO_SIDED|95.0|16.34|36.26||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 16 were considered as non-responders.||36.26|16.34|<0.0001
70919916|NCT02918071|141330327|OTHER||Percentage|97.4|||||TWO_SIDED|95.0|92.69|99.47|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12)|Percentage of patients returned functional AI administered at home (Week 12)|||99.47|92.69|
70919917|NCT02918071|141330327|OTHER||Percentage|96.6|||||TWO_SIDED|95.0|91.48|99.06|||Clopper Pearson Exact CI|One sample confidence interval (Week 16)|Percentage of patients returned functional AI administered at home (Week 16)|||99.06|91.48|
70919918|NCT02918071|141330328|OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|3.0|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 0)|Percentage of mulfunctioning AI used to administer benralizumab at home or clinic (Week 0)|||3.00|0.00|
70919919|NCT02918071|141330328|OTHER||Percentage|0.8|||||TWO_SIDED|95.0|0.02|4.52|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 4)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 4)|||4.52|0.02|
70919920|NCT02918071|141330328|OTHER||Percentage|0.8|||||TWO_SIDED|95.0|0.02|4.59|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 8)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 8)|||4.59|0.02|
70919921|NCT02918071|141330328|OTHER||Percentage|2.6|||||TWO_SIDED|95.0|0.53|7.31|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 12)|||7.31|0.53|
70919922|NCT02918071|141330328|OTHER||Percentage|3.4|||||TWO_SIDED|95.0|0.94|8.52|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 16)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 16)|||8.52|0.94|
70919923|NCT02918071|141330328|OTHER||Percentage|0.6|||||TWO_SIDED|95.0|0.07|1.99|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 0 to 8)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 0 to 8)|||1.99|0.07|
70919924|NCT02918071|141330328|OTHER||Percentage|3.0|||||TWO_SIDED|95.0|1.21|6.07|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12 to 16)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 12 to 16)|||6.07|1.21|
70919925|NCT02918071|141330328|OTHER||Percentage|1.5|||||TWO_SIDED|95.0|0.69|2.85|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 0 to 16)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 0 to 16)|||2.85|0.69|
70919926|NCT00774852|141330407|SUPERIORITY_OR_OTHER|||||||0.85|||||||Chi-squared|Two-sided Pearson's chi-square test||||||0.85
70919927|NCT00774852|141330408|SUPERIORITY_OR_OTHER|||||||0.99|||||||Chi-squared|Two-sided Pearson's chi-square test||||||0.99
70919928|NCT00774852|141330409|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||Chi-squared|Two-sided Pearson's chi-square test||||||0.54
70919929|NCT00774852|141330409|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||Chi-squared|Two-sided Pearson's chi-square test||||||0.72
70919930|NCT00774852|141330410|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||Chi-squared|Two-sided Pearson's chi-square test||||||0.54
70919931|NCT00774852|141330415|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED||||||Chi-squared|Two-sided Pearson's chi-squared test||Comparison of Participants across groups who had negative anti-dsDNA at Week 104. Baseline is defined as the last measurement taken on or prior to the first day of dosing. Analysis is performed on participants with available data.||||>0.99
70919932|NCT00774852|141330416|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED||||||Chi-squared|Two-sided Pearson's chi-squared test||Comparison of Participants across groups who had negative anti-dsDNA at Week 104. Baseline is defined as the last measurement taken on or prior to the first day of dosing. Analysis is performed on participants with available data.||||>0.99
70919933|NCT00774852|141330418|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Chi-squared|Pearson's||Comparison of groups with renal flare||||0.23
70919934|NCT00774852|141330418|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Chi-squared|Pearson's||Comparison of groups with renal flare||||0.61
70919935|NCT00774852|141330418|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED||||||Chi-squared|Pearson's||Comparison of groups with at least one non-renal flare||||>0.99
70919936|NCT00774852|141330418|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED||||||Chi-squared|Pearson's||Comparison of groups with at least one non-renal flare||||>0.99
70919937|NCT00774852|141330423|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED|||||P-value compares actual values between experimental and control groups at Week 52 and is derived from two-sided t-test from and ANCOVA model that adjusts for baseline values.|ANCOVA|||||||0.79
71031917|NCT00834756|141572656|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.37||||||90.0|93.95|107.21|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||107.21|93.95|
71031918|NCT01472341|141572657|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||Multivariate regression analysis|HOMA %B was the response variable and other study parameters were independent variables.||||||0.24
71031919|NCT01472341|141572658|SUPERIORITY_OR_OTHER|||||||0.001|||||||Multivariate regression analysis|PI/I ratio was the response variable and other study parameters were independent variables.||||||0.001
71031920|NCT01472341|141572659|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Multivariate regression analysis|HOMA %B was the response variable and other study parameters were independent variables.||||||<0.0001
71031921|NCT02251886|141572663|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.17||||0.48|TWO_SIDED|95.0|0.77|1.76|||Chi-squared|||||1.76|0.77|0.48
71031922|NCT02251886|141572663|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|0.69|1.46|||Chi-squared|||||1.46|0.69|1.00
71031923|NCT00578552|141572667|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||Fisher Exact|1-tailed||Data were compared between treatment groups using Fisher's exact test for binary outcomes.||||0.77
71031924|NCT00578552|141572667|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|1-tailed||Data were compared between treatment groups using Fisher's exact test for binary outcomes.||||1.00
71031925|NCT02979353|141572685|SUPERIORITY||Risk Ratio (RR)|0.96||||0.017|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 1 applies to the Hospital Discharge timepoint (average 3 days after study enrollment)||||0.017
71031926|NCT02979353|141572685|SUPERIORITY||Risk Ratio (RR)|0.86|||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 2 applies to the Post-Acute Care Discharge time point (occurred on average 31 days after study enrollment)||||<0.0001
71031927|NCT02979353|141572685|SUPERIORITY||Risk Ratio (RR)|0.85|||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 3 applies to the 90 Day Follow-Up After PAC Discharge (occurred, on average, 122 days after study enrollment)||||<0.0001
71031928|NCT02979353|141572686|SUPERIORITY||Mean Difference (Net)|-0.28||||0.02|TWO_SIDED|95.0|||||Regression, Linear|||Statistical Analysis 1 applies to the Hospital Discharge time point (occurred, on average, 3 days after study enrollment)||||0.02
71031929|NCT02979353|141572686|SUPERIORITY||Mean Difference (Net)|-0.59|||<|1e-05|TWO_SIDED|95.0|||||Regression, Linear|||Statistical Analysis 2 applies to Post-Acute Care Discharge time point (occurred, on average, 31 days after study enrollment).||||<0.00001
71031930|NCT02979353|141572686|SUPERIORITY||Mean Difference (Net)|-0.35||||0.01|TWO_SIDED|95.0|||||Regression, Linear|||Statistical Analysis 3 applies to 90-Day Follow Up After PAC Discharge time point (occurred, on average, 122 after study enrollment).||||0.01
71031931|NCT00617305|141572703|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-248.93|STANDARD_DEVIATION|241.978|||TWO_SIDED|95.0|-337.7|-160.2||||||Mean change from Baseline to Week 24||-160.2|-337.7|
71031932|NCT00617305|141572703|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-291.8|STANDARD_DEVIATION|205.864|||TWO_SIDED|95.0|-619.4|35.78||||||Mean change from Baseline to Week 24||35.78|-619.4|
71031933|NCT00617305|141572703|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-253.83|STANDARD_DEVIATION|235.787|||TWO_SIDED|95.0|-334.8|-172.8||||||Mean change from Baseline to Week 24||-172.8|-334.8|
71031934|NCT00617305|141572703|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-291.8|STANDARD_DEVIATION|205.864|||TWO_SIDED|95.0|-619.4|35.78||||||Mean change from Baseline to Week 24||35.78|-619.4|
71031935|NCT00617305|141572704|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.38|STANDARD_DEVIATION|7.954|||TWO_SIDED|95.0|-8.29|-2.46||||||Mean change from Baseline to Week 24||-2.46|-8.29|
71031936|NCT00617305|141572704|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.75|STANDARD_DEVIATION|8.732|||TWO_SIDED|95.0|-29.64|-1.86||||||Mean change from Baseline to Week 24||-1.86|-29.64|
71031937|NCT00617305|141572704|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.56|STANDARD_DEVIATION|8.589|||TWO_SIDED|95.0|-9.51|-3.61||||||Mean change from Baseline to Week 24||-3.61|-9.51|
71031938|NCT00617305|141572704|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.75|STANDARD_DEVIATION|8.732|||TWO_SIDED|95.0|-29.64|-1.86||||||Mean change from Baseline to Week 24||-1.86|-29.64|
71031939|NCT00617305|141572705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06|STANDARD_DEVIATION|4.442|||TWO_SIDED|95.0|-1.69|1.56||||||Mean change from Baseline to Week 24||1.56|-1.69|
71031940|NCT00617305|141572705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.0|STANDARD_DEVIATION|4.082|||TWO_SIDED|95.0|-10.5|2.5||||||Mean change from Baseline to Week 24||2.50|-10.50|
71031941|NCT00617305|141572705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_DEVIATION|4.527|||TWO_SIDED|95.0|-2.07|1.04||||||Mean change from Baseline to Week 24||1.04|-2.07|
71031942|NCT00617305|141572705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.0|STANDARD_DEVIATION|4.082|||TWO_SIDED|95.0|-10.5|2.5||||||Mean change from Baseline to Week 24||2.50|-10.50|
71031943|NCT00617305|141572706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.84|STANDARD_DEVIATION|1.053|||TWO_SIDED|95.0|0.43|1.25||||||Mean change from Baseline to Week 24||1.25|0.43|
71031944|NCT00617305|141572706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33|STANDARD_DEVIATION|0.685|||TWO_SIDED|95.0|-0.77|1.42||||||Mean change from Baseline to Week 24||1.42|-0.77|
71031945|NCT00617305|141572706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.78|STANDARD_DEVIATION|1.021|||TWO_SIDED|95.0|0.41|1.15||||||Mean change from Baseline to Week 24||1.15|0.41|
71031946|NCT00617305|141572706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33|STANDARD_DEVIATION|0.685|||TWO_SIDED|95.0|-0.77|1.42||||||Mean change from Baseline to Week 24||1.42|-0.77|
71031947|NCT00617305|141572707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.2|STANDARD_DEVIATION|44.84|||TWO_SIDED|95.0|-3.9|28.4||||||Mean change from Baseline to Week 4 (LOCF)||28.4|-3.9|
71031948|NCT00617305|141572707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.8|STANDARD_DEVIATION|21.19|||TWO_SIDED|95.0|-26.0|41.5||||||Mean change from Baseline to Week 4 (LOCF)||41.5|-26.0|
71031949|NCT00617305|141572707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|107.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 4 (LOCF)||||
71031950|NCT00617305|141572707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.7|STANDARD_DEVIATION|42.68|||TWO_SIDED|95.0|-2.7|26.2||||||Mean change from Baseline to Week 4 (LOCF)||26.2|-2.7|
71031951|NCT00617305|141572707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.6|STANDARD_DEVIATION|48.03|||TWO_SIDED|95.0|-32.0|87.2||||||Mean change from Baseline to Week 4 (LOCF)||87.2|-32.0|
71031952|NCT00617305|141572707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.6|STANDARD_DEVIATION|41.46|||TWO_SIDED|95.0|-1.4|28.5||||||Mean change from Baseline to Week 12 (LOCF)||28.5|-1.4|
71031953|NCT00617305|141572707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5|STANDARD_DEVIATION|59.09|||TWO_SIDED|95.0|-91.5|96.5||||||Mean change from Baseline to Week 12 (LOCF)||96.5|-91.5|
71031954|NCT00617305|141572707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|87.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
71031955|NCT00617305|141572707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.4|STANDARD_DEVIATION|42.83|||TWO_SIDED|95.0|-2.1|26.9||||||Mean change from Baseline to Week 12 (LOCF)||26.9|-2.1|
71094516|NCT02260986|141696800|SUPERIORITY||difference in percentages|26.8|||<|0.0001|TWO_SIDED|95.0|20.33|33.28||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 16 were considered as non-responders.||33.28|20.33|<0.0001
71094517|NCT02260986|141696801|SUPERIORITY|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 16 were considered as non-responders.|difference in percentages|45.7|||<|0.0001|TWO_SIDED|95.0|35.72|55.66||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level for both comparisons.||55.66|35.72|<0.0001
71031956|NCT00617305|141572707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.4|STANDARD_DEVIATION|63.61|||TWO_SIDED|95.0|-59.6|98.4||||||Mean change from Baseline to Week 12 (LOCF)||98.4|-59.6|
71031957|NCT00617305|141572707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.1|STANDARD_DEVIATION|48.67|||TWO_SIDED|95.0|0.5|35.6||||||Mean change from Baseline to Week 24 (LOCF)||35.6|0.5|
71031958|NCT00617305|141572707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.5|STANDARD_DEVIATION|29.56|||TWO_SIDED|95.0|-56.5|37.5||||||Mean change from Baseline to Week 24 (LOCF)||37.5|-56.5|
71031959|NCT00617305|141572707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|87.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
71031960|NCT00617305|141572707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.0|STANDARD_DEVIATION|47.44|||TWO_SIDED|95.0|-1.0|31.1||||||Mean change from Baseline to Week 24 (LOCF)||31.1|-1.0|
71031961|NCT00617305|141572707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.8|STANDARD_DEVIATION|50.18|||TWO_SIDED|95.0|-52.5|72.1||||||Mean change from Baseline to Week 24 (LOCF)||72.1|-52.5|
71031962|NCT00617305|141572707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2|STANDARD_DEVIATION|77.24|||TWO_SIDED|95.0|-25.6|30.1||||||Mean change from Baseline to Week 36 (LOCF)||30.1|-25.6|
71031963|NCT00617305|141572707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.0|STANDARD_DEVIATION|93.16|||TWO_SIDED|95.0|-182.2|114.2||||||Mean change from Baseline to Week 36 (LOCF)||114.2|-182.2|
71031964|NCT00617305|141572707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|67.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
71031965|NCT00617305|141572707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_DEVIATION|78.5|||TWO_SIDED|95.0|-28.4|24.8||||||Mean change from Baseline to Week 36 (LOCF)||24.8|-28.4|
71031966|NCT00617305|141572707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.8|STANDARD_DEVIATION|92.46|||TWO_SIDED|95.0|-128.6|101.0||||||Mean change from Baseline to Week 36 (LOCF)||101.0|-128.6|
71031967|NCT00617305|141572707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.6|STANDARD_DEVIATION|82.07|||TWO_SIDED|95.0|-15.0|44.2||||||Mean change from Baseline to Week 48 (LOCF)||44.2|-15.0|
71031968|NCT00617305|141572707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-49.8|STANDARD_DEVIATION|126.75|||TWO_SIDED|95.0|-251.4|151.9||||||Mean change from Baseline to Week 48 (LOCF)||151.9|-251.4|
71031969|NCT00617305|141572707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|67.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
71031970|NCT00617305|141572707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.4|STANDARD_DEVIATION|88.11|||TWO_SIDED|95.0|-22.4|37.3||||||Mean change from Baseline to Week 48 (LOCF)||37.3|-22.4|
71031971|NCT00617305|141572707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.4|STANDARD_DEVIATION|121.55|||TWO_SIDED|95.0|-177.3|124.5||||||Mean change from Baseline to Week 48 (LOCF)||124.5|-177.3|
71031972|NCT00617305|141572708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|1.5|||TWO_SIDED|95.0|-1.1|0.0||||||Mean change from Baseline to Week 4 (LOCF)||0.0|-1.1|
71031973|NCT00617305|141572708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|STANDARD_DEVIATION|1.5|||TWO_SIDED|95.0|-1.6|3.1||||||Mean change from Baseline to Week 4 (LOCF)||3.1|-1.6|
71031974|NCT00617305|141572708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 4 (LOCF)||||
71031975|NCT00617305|141572708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|1.54|||TWO_SIDED|95.0|-0.9|0.1||||||Mean change from Baseline to Week 4 (LOCF)||0.1|-0.9|
71031976|NCT00617305|141572708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|STANDARD_DEVIATION|1.52|||TWO_SIDED|95.0|-1.5|2.3||||||Mean change from Baseline to Week 4 (LOCF)||2.3|-1.5|
71031977|NCT00617305|141572708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|1.45|||TWO_SIDED|95.0|-1.1|0.0||||||Mean change from Baseline to Week 12 (LOCF)||0.0|-1.1|
71031978|NCT00617305|141572708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5|STANDARD_DEVIATION|2.38|||TWO_SIDED|95.0|-2.3|5.3||||||Mean change from Baseline to Week 12 (LOCF)||5.3|-2.3|
71031979|NCT00617305|141572708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
71031980|NCT00617305|141572708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|1.67|||TWO_SIDED|95.0|-0.9|0.2||||||Mean change from Baseline to Week 12 (LOCF)||0.2|-0.9|
71031981|NCT00617305|141572708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2|STANDARD_DEVIATION|2.17|||TWO_SIDED|95.0|-1.5|3.9||||||Mean change from Baseline to Week 12 (LOCF)||3.9|-1.5|
71031982|NCT00617305|141572708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_DEVIATION|1.81|||TWO_SIDED|95.0|-1.5|-0.2||||||Mean change from Baseline to Week 24 (LOCF)||-0.2|-1.5|
71031983|NCT00617305|141572708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|0.75|||TWO_SIDED|95.0|-1.8|0.6||||||Mean change from Baseline to Week 24 (LOCF)||0.6|-1.8|
71031984|NCT00617305|141572708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
70972704|NCT03066102|141452237|OTHER|||||||0.006||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of serratus anterior during scapular elevation.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."||||0.006
70972705|NCT03066102|141452237|OTHER|||||||0.154||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of upper trapezius during scapular protraction.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."||||0.154
70972706|NCT03066102|141452237|OTHER|||||||0.096||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of lower trapezius during scapular protraction.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."||||0.096
70972707|NCT03066102|141452237|OTHER|||||||0.037||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of serratus anterior during scapular protraction.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."||||0.037
71031985|NCT00617305|141572708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|1.72|||TWO_SIDED|95.0|-1.4|-0.3||||||Mean change from Baseline to Week 24 (LOCF)||-0.3|-1.4|
71031986|NCT00617305|141572708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|0.71|||TWO_SIDED|95.0|-1.4|0.4||||||Mean change from Baseline to Week 24 (LOCF)||0.4|-1.4|
70919938|NCT00774852|141330423|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED|||||P-value compares actual values between experimental and control groups at Week 52 and is derived from two-sided t-test from and ANCOVA model that adjusts for baseline values.|ANCOVA|||||||0.74
70919939|NCT00774852|141330424|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||Chi-squared|Pearson's||Comparison of groups for Pneumococcal vaccines||||0.43
70919940|NCT00774852|141330424|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Chi-squared|Pearson's||Comparison of groups for Tetanus Toxoid vaccines||||0.99
70919941|NCT01827787|141330437|SUPERIORITY|||||||0.42|||||||Fisher Exact|||"Using a one sample binomial design, with 45 patients there was 90% power to detect a null hypothesis 30% overall response rate (historical control) versus an alternative hypothesis of 53% overall response rate assuming a two-sided 10% alpha.~Of note, cohort 2: TNBC did not fully accrue 45 patients so a testing was not done."||||0.42
70919942|NCT03482635|141330446|OTHER||Risk Difference (RD)|0.042|||||TWO_SIDED|95.0|-0.105|0.202|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.202|-0.105|
70919943|NCT03482635|141330446|OTHER||Risk Difference (RD)|0.087|||||TWO_SIDED|95.0|-0.069|0.268|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.268|-0.069|
70919944|NCT03482635|141330446|OTHER||Risk Difference (RD)|0.071|||||TWO_SIDED|95.0|-0.081|0.226|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.226|-0.081|
71031987|NCT00617305|141572708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|1.79|||TWO_SIDED|95.0|-1.2|0.1||||||Mean change from Baseline to Week 36 (LOCF)||0.1|-1.2|
71031988|NCT00617305|141572708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|STANDARD_DEVIATION|2.0|||TWO_SIDED|95.0|-2.2|4.2||||||Mean change from Baseline to Week 36 (LOCF)||4.2|-2.2|
71031989|NCT00617305|141572708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
71031990|NCT00617305|141572708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|1.85|||TWO_SIDED|95.0|-1.0|0.2||||||Mean change from Baseline to Week 36 (LOCF)||0.2|-1.0|
71031991|NCT00617305|141572708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|STANDARD_DEVIATION|1.79|||TWO_SIDED|95.0|-1.4|3.0||||||Mean change from Baseline to Week 36 (LOCF)||3.0|-1.4|
71031992|NCT00617305|141572708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|2.12|||TWO_SIDED|95.0|-1.4|0.1||||||Mean change from Baseline to Week 48 (LOCF)||0.1|-1.4|
71031993|NCT00617305|141572708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|STANDARD_DEVIATION|3.46|||TWO_SIDED|95.0|-4.5|6.5||||||Mean change from Baseline to Week 48 (LOCF)||6.5|-4.5|
71031994|NCT00617305|141572708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
71031995|NCT00617305|141572708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|2.3|||TWO_SIDED|95.0|-1.3|0.3||||||Mean change from Baseline to Week 48 (LOCF)||0.3|-1.3|
71031996|NCT00617305|141572708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|STANDARD_DEVIATION|3.03|||TWO_SIDED|95.0|-3.0|4.6||||||Mean change from Baseline to Week 48 (LOCF)||4.6|-3.0|
71031997|NCT00617305|141572709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_DEVIATION|3.98|||TWO_SIDED|95.0|-2.7|0.4||||||Mean change from Baseline to Week 12 (LOCF)||0.4|-2.7|
71031998|NCT00617305|141572709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_DEVIATION|4.86|||TWO_SIDED|95.0|-6.5|9.0||||||Mean change from Baseline to Week 12 (LOCF)||9.0|-6.5|
71031999|NCT00617305|141572709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
71032000|NCT00617305|141572709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|4.09|||TWO_SIDED|95.0|-2.3|0.6||||||Mean change from Baseline to Week 12 (LOCF)||0.6|-2.3|
71032001|NCT00617305|141572709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_DEVIATION|4.45|||TWO_SIDED|95.0|-4.9|6.1||||||Mean change from Baseline to Week 12 (LOCF)||6.1|-4.9|
70972708|NCT03066102|141452238|OTHER|||||||8.5e-05||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle strength of serratus anterior during maximum voluntary isometric muscle contraction.~Muscle fatigue would decrease muscle strength during maximum voluntary isometric muscle contraction.~One-way repeated measures analysis of variance."||||0.000085
70972709|NCT03066102|141452238|OTHER|||||||0.037||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle strength of upper trapezius during maximum voluntary isometric muscle contraction.~Muscle fatigue would decrease muscle strength during maximum voluntary isometric muscle contraction.~One-way repeated measures analysis of variance."||||0.037
70972710|NCT03066102|141452238|OTHER|||||||0.382||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle strength of lower trapezius during maximum voluntary isometric muscle contraction.~Muscle fatigue would decrease muscle strength during maximum voluntary isometric muscle contraction.~One-way repeated measures analysis of variance."||||0.382
70972711|NCT03066102|141452239|OTHER|||||||0.000467||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||The effects of muscle fatigue on scapular posterior tilt during scaption. Muscle fatigue would change scapular kinematics during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on kinematics changed of scapular posterior tilt during each angle of scaption.||||0.000467
70972712|NCT03066102|141452239|OTHER|||||||0.093||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during ascending 30 degree of scaption.~One-way repeated measures analysis of variance."||||0.093
70972713|NCT03066102|141452239|OTHER|||||||0.062||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during ascending 60 degree of scaption.~One-way repeated measures analysis of variance."||||0.062
70972714|NCT03066102|141452239|OTHER|||||||0.04||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during ascending 90 degree of scaption.~One-way repeated measures analysis of variance."||||0.04
70972715|NCT03066102|141452239|OTHER|||||||0.000147||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during ascending 120 degree of scaption.~One-way repeated measures analysis of variance."||||0.000147
70972716|NCT03066102|141452239|OTHER|||||||1.2e-05||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during descending 120 degree of scaption.~One-way repeated measures analysis of variance."||||0.000012
70972717|NCT03066102|141452239|OTHER|||||||0.007||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during descending 90 degree of scaption.~One-way repeated measures analysis of variance."||||0.007
70972718|NCT03066102|141452239|OTHER|||||||0.059||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during descending 60 degree of scaption.~One-way repeated measures analysis of variance."||||0.059
70972719|NCT03066102|141452239|OTHER|||||||0.032||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during descending 30 degree of scaption.~One-way repeated measures analysis of variance."||||0.032
70972720|NCT03066102|141452239|OTHER|||||||1.5e-05||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||The effects of muscle fatigue on scapular internal rotation during scaption Muscle fatigue would change scapular kinematics during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on kinematics changed of scapular internal rotation during each angle of scaption.||||0.000015
70972721|NCT03066102|141452239|OTHER|||||||0.296||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during ascending 30 degree of scaption.~One-way repeated measures analysis of variance."||||0.296
70972722|NCT03066102|141452239|OTHER|||||||0.457||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during ascending 60 degree of scaption.~One-way repeated measures analysis of variance."||||0.457
71032002|NCT00617305|141572709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|5.0|||TWO_SIDED|95.0|-2.7|1.1||||||Mean change from Baseline to Week 24 (LOCF)||1.1|-2.7|
71032003|NCT00617305|141572709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3|STANDARD_DEVIATION|4.03|||TWO_SIDED|95.0|-7.7|5.2||||||Mean change from Baseline to Week 24 (LOCF)||5.2|-7.7|
71032004|NCT00617305|141572709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
71032005|NCT00617305|141572709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_DEVIATION|4.84|||TWO_SIDED|95.0|-2.6|0.9||||||Mean change from Baseline to Week 24 (LOCF)||0.9|-2.6|
71032006|NCT00617305|141572709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4|STANDARD_DEVIATION|3.51|||TWO_SIDED|95.0|-5.8|3.0||||||Mean change from Baseline to Week 24 (LOCF)||3.0|-5.8|
70972723|NCT03066102|141452239|OTHER|||||||0.311||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during ascending 90 degree of scaption.~One-way repeated measures analysis of variance."||||0.311
70972724|NCT03066102|141452239|OTHER|||||||0.004||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during ascending 120 degree of scaption.~One-way repeated measures analysis of variance."||||0.004
70972725|NCT03066102|141452239|OTHER|||||||0.002||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during descending 120 degree of scaption.~One-way repeated measures analysis of variance."||||0.002
71032007|NCT00617305|141572709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|5.2|||TWO_SIDED|95.0|-2.3|1.7||||||Mean change from Baseline to Week 36 (LOCF)||1.7|-2.3|
71032008|NCT00617305|141572709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|4.65|||TWO_SIDED|95.0|-8.1|6.6||||||Mean change from Baseline to Week 36 (LOCF)||6.6|-8.1|
71032009|NCT00617305|141572709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
70919945|NCT03482635|141330447|OTHER||Risk Difference (RD)|-0.051|||||TWO_SIDED|95.0|-0.276|0.176|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.176|-0.276|
70919946|NCT03482635|141330447|OTHER||Risk Difference (RD)|0.043|||||TWO_SIDED|95.0|-0.199|0.28|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.280|-0.199|
70919947|NCT03482635|141330447|OTHER||Risk Difference (RD)|0.033|||||TWO_SIDED|95.0|-0.204|0.252|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.252|-0.204|
70919948|NCT03482635|141330448|OTHER||Risk Difference (RD)|0.083|||||TWO_SIDED|95.0|-0.072|0.258|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.258|-0.072|
70919949|NCT03482635|141330448|OTHER||Risk Difference (RD)|0.087|||||TWO_SIDED|95.0|-0.069|0.268|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.268|-0.069|
70919950|NCT03482635|141330448|OTHER||Risk Difference (RD)|0.071|||||TWO_SIDED|95.0|-0.081|0.226|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.226|-0.081|
70919951|NCT03482635|141330449|OTHER||Risk Difference (RD)|0.083|||||TWO_SIDED|95.0|-0.072|0.258|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\].|||0.258|-0.072|
70919952|NCT03482635|141330449|OTHER||Risk Difference (RD)|0.043|||||TWO_SIDED|95.0|-0.104|0.21|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\].|||0.210|-0.104|
70919953|NCT03482635|141330449|OTHER||Risk Difference (RD)|0.036|||||TWO_SIDED|95.0|-0.11|0.177|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\].|||0.177|-0.110|
70972726|NCT03066102|141452239|OTHER|||||||0.137||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during descending 90 degree of scaption.~One-way repeated measures analysis of variance."||||0.137
70972727|NCT03066102|141452239|OTHER|||||||0.636||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during descending 60 degree of scaption.~One-way repeated measures analysis of variance."||||0.636
70972728|NCT03066102|141452239|OTHER|||||||0.406||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during descending 30 degree of scaption.~One-way repeated measures analysis of variance."||||0.406
70972729|NCT03066102|141452239|OTHER|||||||0.001||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||The effects of muscle fatigue on scapular upward rotation during scaption. Muscle fatigue would change scapular kinematics during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on kinematics changed of scapular upward rotation during each angle of scaption.||||0.001
70972730|NCT03066102|141452239|OTHER|||||||0.65||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during ascending 30 degree of scaption.~One-way repeated measures analysis of variance."||||0.650
70972731|NCT03066102|141452239|OTHER|||||||0.141||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during ascending 60 degree of scaption.~One-way repeated measures analysis of variance."||||0.141
70972732|NCT03066102|141452239|OTHER|||||||0.021||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during ascending 90 degree of scaption.~One-way repeated measures analysis of variance."||||0.021
70972733|NCT03066102|141452239|OTHER|||||||0.005||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during ascending 120 degree of scaption.~One-way repeated measures analysis of variance."||||0.005
70972734|NCT03066102|141452239|OTHER|||||||0.083||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during descending 120 degree of scaption.~One-way repeated measures analysis of variance."||||0.083
70972735|NCT03066102|141452239|OTHER|||||||0.389||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during descending 90 degree of scaption.~One-way repeated measures analysis of variance."||||0.389
70972736|NCT03066102|141452239|OTHER|||||||0.542||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during descending 60 degree of scaption.~One-way repeated measures analysis of variance."||||0.542
70972737|NCT03066102|141452239|OTHER|||||||0.263||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during descending 30 degree of scaption.~One-way repeated measures analysis of variance."||||0.263
70972738|NCT03066102|141452240|OTHER|||||||0.331||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of upper trapezius during scaption.~Muscle fatigue would change muscle activation during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on muscle activation changed of upper trapezius during each angle of scaption."||||0.331
70972739|NCT03066102|141452240|OTHER|||||||0.627||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of lower trapezius during scaption.~Muscle fatigue would change muscle activation during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on muscle activation changed of lower trapezius during each angle of scaption."||||0.627
71032010|NCT00617305|141572709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|5.07|||TWO_SIDED|95.0|-2.2|1.5||||||Mean change from Baseline to Week 36 (LOCF)||1.5|-2.2|
71032011|NCT00617305|141572709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|4.02|||TWO_SIDED|95.0|-5.8|4.2||||||Mean change from Baseline to Week 36 (LOCF)||4.2|-5.8|
71032012|NCT00617305|141572709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|6.33|||TWO_SIDED|95.0|-2.8|2.1||||||Mean change from Baseline to Week 48 (LOCF)||2.1|-2.8|
71032013|NCT00617305|141572709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|6.86|||TWO_SIDED|95.0|-11.4|10.4||||||Mean change from Baseline to Week 48 (LOCF)||10.4|-11.4|
71032014|NCT00617305|141572709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
71032015|NCT00617305|141572709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|6.28|||TWO_SIDED|95.0|-2.7|1.9||||||Mean change from Baseline to Week 48 (LOCF)||1.9|-2.7|
71032016|NCT00617305|141572709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|5.94|||TWO_SIDED|95.0|-8.0|6.8||||||Mean change from Baseline to Week 48 (LOCF)||6.8|-8.0|
71032017|NCT00617305|141572711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.5||||||||||||Mean change from Baseline to Week 4 (LOCF)||||
71032018|NCT00617305|141572711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|0.28||||||||||||Mean change from Baseline to Week 4 (LOCF)||||
71032019|NCT00617305|141572711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.49||||||||||||Mean change from Baseline to Week 4 (LOCF)||||
71032020|NCT00617305|141572711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|0.28||||||||||||Mean change from Baseline to Week 4 (LOCF)||||
71032021|NCT00617305|141572711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|0.63||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
71032022|NCT00617305|141572711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_DEVIATION|1.07||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
71032023|NCT00617305|141572711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|0.64||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
71032024|NCT00617305|141572711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_DEVIATION|1.07||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
71032025|NCT00617305|141572711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.83||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
71032026|NCT00617305|141572711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|0.34||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
71032027|NCT00617305|141572711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.81||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
71032028|NCT00617305|141572711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|0.34||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
71032029|NCT00617305|141572711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.92||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
71032030|NCT00617305|141572711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|0.9||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
71032031|NCT00617305|141572711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.91||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
71032032|NCT00617305|141572711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|0.9||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
71032033|NCT00617305|141572711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.91||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
71032034|NCT00617305|141572711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|0.77||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
71032035|NCT00617305|141572711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.88||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
71032036|NCT00617305|141572711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|0.77||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
71032037|NCT03897088|141572732|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 16||||<0.00001
71032038|NCT03897088|141572741|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 16||||<0.00001
71032039|NCT03897088|141572742|SUPERIORITY||||||<|1e-05|||||||Mixed Models Analysis|||Week 16||||<0.00001
71032040|NCT03897088|141572743|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 16||||<0.00001
71032041|NCT03897088|141572744|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 16||||<0.00001
71032042|NCT03897088|141572745|SUPERIORITY||||||<|1e-05|||||||Mixed Models Analysis|||Week 16||||<0.00001
71032043|NCT03897088|141572746|SUPERIORITY||||||<|1e-05||||||Log Rank Test p-Value|Kaplan-Meier Estimates|||||||<0.00001
71032044|NCT03897088|141572747|SUPERIORITY||||||<|1e-05||||||Log Rank Test p-Value|Kaplan-Meier Estimates|||||||<0.00001
71032045|NCT03897088|141572748|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||||||<0.00001
71032046|NCT03897088|141572749|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||PASI-75||||<0.00001
71032047|NCT03897088|141572749|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||PASI-90||||<0.00001
71032048|NCT03897088|141572749|SUPERIORITY|||||||4e-05|||||||Cochran-Mantel-Haenszel|||PASI-100||||0.00004
71032049|NCT03897088|141572750|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 16||||<0.00001
71032050|NCT03897088|141572751|SUPERIORITY||||||<|1e-05|||||||Mixed Models Analysis|||Week 16||||<0.00001
71032051|NCT03897088|141572752|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 16||||<0.00001
71032052|NCT03897088|141572753|SUPERIORITY||||||<|1e-05||||||Week 16|Cochran-Mantel-Haenszel|||||||<0.00001
71032053|NCT03897088|141572754|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 12||||<0.00001
70972740|NCT03066102|141452240|OTHER|||||||0.042||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of serratus anterior during scaption.~Muscle fatigue would change muscle activation during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on muscle activation changed of serratus anterior during each angle of scaption."||||0.042
70972741|NCT03066102|141452240|OTHER|||||||0.021||||||The level of statistical significance was adjusted at P\<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during ascending 30\~60 degree of scaption.~One-way repeated measures analysis of variance."||||0.021
71154076|NCT04941482|141800631|SUPERIORITY||Median Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|1.3|<|0.05|TWO_SIDED|95.0|-1.9|3.2||The threshold for statistical significance was p = 0.05.|t-test, 2 sided||Treatment Difference = Intervention group - Control group|We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.|(1) Variables with multiple measurements over time were compared using the repeated measures ANOVA test to assess changes in Patient Health Questionnaire-9 score before and after intervention in two groups, calculating the time\*group interaction; (2) Effect sizes after intervention are measured using Cohen's D, with values indicating small (d = 0.2), medium (d = 0.5), and large (d ≥ 0.8) effects.|3.2|-1.9|<0.05
71154077|NCT04941482|141800632|SUPERIORITY||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|2.5|<|0.05|TWO_SIDED|95.0|-7.6|2.5||The threshold for statistical significance was p = 0.05.|t-test, 2 sided||Treatment Difference = Intervention group - Control group|We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.|(1) Variables with multiple measurements over time were compared using the repeated measures ANOVA test to assess changes in Fatigue Severity Scale score before and after intervention in two groups, calculating the time\*group interaction; (2) Effect sizes after intervention are measured using Cohen's D, with values indicating small (d = 0.2), medium (d = 0.5), and large (d ≥ 0.8) effects.|2.5|-7.6|<0.05
71154078|NCT04941482|141800633|SUPERIORITY||Mean Difference (Net)|-2.1|STANDARD_ERROR_OF_MEAN|1.7|<|0.05|TWO_SIDED|95.0|-5.4|1.3||The threshold for statistical significance was p = 0.05.|t-test, 2 sided||Treatment Difference = Intervention group - Control group|We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.|(1) Variables with multiple measurements over time were compared using the repeated measures ANOVA test to assess changes in Mini-Mental State Examinationscore before and after intervention in two groups, calculating the time\*group interaction; (2) Effect sizes after intervention are measured using Cohen's D, with values indicating small (d = 0.2), medium (d = 0.5), and large (d ≥ 0.8) effects.|1.3|-5.4|<0.05
71154079|NCT04941482|141800634|SUPERIORITY|Over 6 months, the number of patients who losted to follow-up of intervention and control group were respectively 9:0 (after 1 month), 9:0 (after 3 months), and 9:3 (after 6 months).|Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|7.4|<|0.05|TWO_SIDED|95.0|-14.5|14.7|||t-test, 2 sided||Treatment Difference = Intervention group - Control group|We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.|(1) Variables with multiple measurements over time were compared using the repeated measures ANOVA test to assess changes in Barthel Index score before and after intervention in two groups, calculating the time\*group interaction; (2) Effect sizes after intervention are measured using Cohen's D, with values indicating small (d = 0.2), medium (d = 0.5), and large (d ≥ 0.8) effects.|14.7|-14.5|<0.05
71032054|NCT03897088|141572755|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 12||||<0.00001
71032055|NCT00855738|141572764|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 3: p-value versus baseline.||||<0.0001
71032056|NCT00855738|141572764|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 6: p-value versus baseline.||||<0.0001
71032057|NCT00855738|141572765|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 3 \>=25% reduction: p-value versus baseline.||||<0.0001
71032058|NCT00855738|141572765|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 3 \>=75% reduction: p-value versus baseline.||||<0.0001
71032059|NCT00855738|141572765|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 6: \>=25% reduction: p-value versus baseline.||||<0.0001
71032060|NCT00855738|141572765|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 6: \>=75% reduction: p-value versus baseline.||||<0.0001
70972742|NCT03066102|141452240|OTHER|||||||0.018||||||The level of statistical significance was adjusted at P\<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during ascending 60\~90 degree of scaption.~One-way repeated measures analysis of variance."||||0.018
70972743|NCT03066102|141452240|OTHER|||||||0.002||||||The level of statistical significance was adjusted at P\<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during ascending 90\~120 degree of scaption.~One-way repeated measures analysis of variance."||||0.002
70972744|NCT03066102|141452240|OTHER|||||||0.002||||||The level of statistical significance was adjusted at P\<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during descending 120\~90 degree of scaption.~One-way repeated measures analysis of variance."||||0.002
70972745|NCT03066102|141452240|OTHER|||||||0.035||||||The level of statistical significance was adjusted at P\<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during descending 90\~60 degree of scaption.~One-way repeated measures analysis of variance."||||0.035
70972746|NCT03066102|141452240|OTHER|||||||0.05||||||The level of statistical significance was adjusted at P\<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during descending 60\~30 degree of scaption.~One-way repeated measures analysis of variance."||||0.05
70972747|NCT03066102|141452241|OTHER|||||||0.5||||||The level of statistical significance was set at P \< 0.05|ANOVA|||"The effects of muscle fatigue on muscle onset timing of upper trapezius during scaption.~Muscle fatigue would change muscle onset timing during scaption. One-way repeated measures analysis of variance."||||0.5
70972748|NCT03066102|141452241|OTHER|||||||0.843||||||The level of statistical significance was set at P \< 0.05|ANOVA|||"The effects of muscle fatigue on muscle onset timing of lower trapezius during scaption.~Muscle fatigue would change muscle onset timing during scaption. One-way repeated measures analysis of variance."||||0.843
70972749|NCT03066102|141452241|OTHER|||||||0.466||||||The level of statistical significance was set at P \< 0.05|ANOVA|||"The effects of muscle fatigue on muscle onset timing of serratus anterior during scaption.~Muscle fatigue would change muscle onset timing during scaption. One-way repeated measures analysis of variance."||||0.466
70972750|NCT01903837|141452250|EQUIVALENCE|Equivalence margin of 10 points|Least Square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.17||0.3|TWO_SIDED|95.0|-2.0|2.6|||Least Square Mean Difference|||||2.6|-2.0|0.3
70972751|NCT01903837|141452251|SUPERIORITY|||||||0.006|||||||Mixed Models Analysis|||||||0.006
70972752|NCT01903837|141452251|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70972753|NCT01903837|141452252|SUPERIORITY|||||||0.018|||||||Mixed Models Analysis|||||||0.018
70972754|NCT01903837|141452252|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70972755|NCT01926782|141452280|SUPERIORITY_OR_OTHER|Alirocumab 300 mg group was compared to placebo group using an appropriate contrast statement.|LS Mean Difference|-52.4|||<|0.0001|TWO_SIDED|97.5|-59.8|-45.0||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||At Week 24||-45.0|-59.8|<0.0001
70972756|NCT01926782|141452280|SUPERIORITY_OR_OTHER|Alirocumab 300 mg group was compared to placebo group using an appropriate contrast statement.|LS Mean Difference|-55.2|||<|0.0001|TWO_SIDED|97.5|-62.3|-48.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Week 21-24||-48.1|-62.3|<0.0001
70972757|NCT01926782|141452281|SUPERIORITY_OR_OTHER|Alirocumab 300 mg group was compared to placebo group using an appropriate contrast statement.|LS Mean Difference|-58.7|||<|0.0001|TWO_SIDED|97.5|-65.0|-52.4||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||At Week 24||-52.4|-65.0|<0.0001
70972758|NCT01926782|141452281|SUPERIORITY_OR_OTHER|Alirocumab 300 mg group was compared to placebo group using an appropriate contrast statement.|LS Mean Difference|-65.0|||<|0.0001|TWO_SIDED|97.5|-70.4|-59.5||Threshold for significance ≤ 0.025|Mixed Models Analysis|||Week 21-24||-59.5|-70.4|< 0.0001
70972759|NCT01926782|141452282|SUPERIORITY_OR_OTHER||LS Mean Difference|-59.0|||<|0.0001|TWO_SIDED|97.5|-64.6|-53.4||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level.||-53.4|-64.6|<0.0001
70972760|NCT01926782|141452283|SUPERIORITY_OR_OTHER||LS Mean Difference|-62.0|||<|0.0001|TWO_SIDED|97.5|-67.7|-56.2||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-56.2|-67.7|<0.0001
70972761|NCT01926782|141452284|SUPERIORITY_OR_OTHER||LS Mean Difference|-58.7|||<|0.0001|TWO_SIDED|97.5|-64.5|-53.0||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-53.0|-64.5|<0.0001
70972762|NCT01926782|141452285|SUPERIORITY_OR_OTHER||LS Mean Difference|-56.3|||<|0.0001|TWO_SIDED|97.5|-62.3|-50.3||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-50.3|-62.3|<0.0001
70972763|NCT01926782|141452286|SUPERIORITY_OR_OTHER||LS Mean Difference|-59.5|||<|0.0001|TWO_SIDED|97.5|-65.0|-54.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-54.1|-65.0|<0.0001
70972764|NCT01926782|141452287|SUPERIORITY_OR_OTHER||LS Mean Difference|-59.4|||<|0.0001|TWO_SIDED|97.5|-64.8|-54.0||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-54.0|-64.8|<0.0001
71032061|NCT00855738|141572766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0039|TWO_SIDED||||||McNemar|||Month 3: p-value versus baseline.||||0.0039
71032062|NCT00855738|141572766|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 6: p-value versus baseline.||||<0.0001
71032063|NCT00855738|141572767|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
71032064|NCT00855738|141572778|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1797|TWO_SIDED||||||t-test, 2 sided|||Depression domain: P-value vs baseline.||||0.1797
71032065|NCT00855738|141572778|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0433|TWO_SIDED||||||t-test, 2 sided|||Anxiety domain: P-value vs baseline.||||0.0433
71032066|NCT00855738|141572779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8284|TWO_SIDED||||||t-test, 2 sided|||Energy: p-value versus baseline.||||0.8284
71032067|NCT00855738|141572779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6299|TWO_SIDED||||||t-test, 2 sided|||Emotions (mood): p-value versus baseline.||||0.6299
71032068|NCT00855738|141572779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6162|TWO_SIDED||||||t-test, 2 sided|||Daily activities: p-value versus baseline.||||0.6162
71032069|NCT00855738|141572779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5609|TWO_SIDED||||||t-test, 2 sided|||Mental function: p-value versus baseline.||||0.5609
71032070|NCT00855738|141572779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4635|TWO_SIDED||||||t-test, 2 sided|||Medication effects (physical/ mental): p-value versus baseline.||||0.4635
71032071|NCT00855738|141572779|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Worry about seizures (impact of seizures): p-value versus baseline.||||<0.0001
71032072|NCT00855738|141572779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0258|TWO_SIDED||||||t-test, 2 sided|||Overall quality of life: p-value versus baseline.||||0.0258
71032073|NCT00855738|141572780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7822|TWO_SIDED||||||t-test, 2 sided|||Month 3: p-value versus baseline.||||0.7822
71032074|NCT00855738|141572780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4471|TWO_SIDED||||||t-test, 2 sided|||Month 6: p-value versus baseline.||||0.4471
71032075|NCT00855738|141572781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2452|TWO_SIDED||||||t-test, 2 sided|||Sleep disturbance: p-value versus baseline.||||0.2452
71032076|NCT00855738|141572781|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||t-test, 2 sided|||Snoring: p-value verus baseline.||||1.0000
71032077|NCT00855738|141572781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4253|TWO_SIDED||||||t-test, 2 sided|||Awake short of breath: p-value versus baseline.||||0.4253
71032078|NCT00855738|141572781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0572|TWO_SIDED||||||t-test, 2 sided|||Quantity: p-value versus baseline.||||0.0572
71032079|NCT00855738|141572781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0625|TWO_SIDED||||||t-test, 2 sided|||Adequacy: p-value versus baseline.||||0.0625
71032080|NCT00855738|141572781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.554|TWO_SIDED||||||t-test, 2 sided|||Somnolence: p-value versus baseline.||||0.5540
71032081|NCT00855738|141572781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4204|TWO_SIDED||||||t-test, 2 sided|||Sleep problems (summary 6): p-value versus baseline.||||0.4204
71032082|NCT00855738|141572781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4869|TWO_SIDED||||||t-test, 2 sided|||Sleep problems (summary 9): p-value versus baseline.||||0.4869
71032083|NCT00855738|141572782|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0863|TWO_SIDED||||||McNemar|||Month 6: p-value versus baseline.||||0.0863
71032084|NCT00855738|141572783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0226|TWO_SIDED||||||t-test, 2 sided|||Number of visits to a specialist because of epilepsy: p-value versus baseline.||||0.0226
71032085|NCT00855738|141572783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017|TWO_SIDED||||||t-test, 2 sided|||Number of visits to the emergency room because of epilepsy: p-value versus baseline.||||0.0017
71032086|NCT00855738|141572784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3141|TWO_SIDED||||||t-test, 2 sided|||P-value versus baseline.||||0.3141
71032087|NCT00855738|141572785|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0708|TWO_SIDED||||||t-test, 2 sided|||Cessation of usual occupation: p-value versus baseline.||||0.0708
71032088|NCT00855738|141572785|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||t-test, 2 sided|||Requirement of informal caregiver: p-value versus baseline.||||1.0000
71032089|NCT00855738|141572785|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||t-test, 2 sided|||Required admission to ICU: p-value versus baseline.||||1.0000
71032090|NCT03555305|141572804|EQUIVALENCE|Analysis was performed using linear mixed effects model and participant as a random effect, with period, sequence, and treatment as fixed effects. The estimate of the ratio of means of each PK/PD parameters between the 2 treatments and the corresponding 90% confidence interval were calculated. A typical bio-equivalence limit (0.8 to 1.25) was used as equivalence margin.|Ratio of geometric least squares means|0.961|||||TWO_SIDED|90.0|0.886|1.04|||Linear mixed-effects model|||||1.04|0.886|
71032091|NCT03555305|141572805|EQUIVALENCE|Analysis was performed using linear mixed effects model and participant as a random effect, with period, sequence, and treatment as fixed effects. The estimate of the ratio of means of each PK/PD parameters between the 2 treatments and the corresponding 90% confidence interval were calculated. A typical bio-equivalence limit (0.8 to 1.25) was used as equivalence margin.|Ratio of geometric least squares means|0.943|||||TWO_SIDED|90.0|0.874|1.02|||Linear mixed-effects model|||||1.02|0.874|
71032092|NCT00323193|141572846|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||ANOVA|||||||.720
71032093|NCT00323193|141572847|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||ANOVA|||||||.710
71032094|NCT02100228|141572848|SUPERIORITY|This was a descriptive study, and there was no formal pre-defined hypothesis testing.|Risk Ratio (RR)|0.0||||0.0151|TWO_SIDED|95.0|0.0|0.6425||nominal p-value|Fisher Exact|||Display exact confidence limits for relative risk and Fisher's exact test for comparisons of two proportions.||0.6425|0.0000|0.0151
71032095|NCT02100228|141572850|SUPERIORITY|This was a descriptive study, and there was no formal pre-defined hypothesis testing.|Risk Ratio (RR)|0.4905||||0.3378|TWO_SIDED|95.0|0.1046|2.0678||nominal p-value|Fisher Exact|||Display exact confidence limits for relative risk and Fisher's exact test for comparisons of two proportions.||2.0678|0.1046|0.3378
71032096|NCT02100228|141572851|SUPERIORITY|This was a descriptive study, and there was no formal pre-defined hypothesis testing.|Risk Ratio (RR)|0.83||||0.6851|TWO_SIDED|95.0|0.3433|1.8916||nominal p-value|Fisher Exact|||Display exact confidence limits for relative risk and Fisher's exact test for comparisons of two proportions.||1.8916|0.3433|0.6851
71032097|NCT02100228|141572852|SUPERIORITY|This was a descriptive study, and there was no formal pre-defined hypothesis testing.|Risk Ratio (RR)|1.9841|||>|0.9999|TWO_SIDED|95.0|0.1866|53.9968||nominal p-value|Fisher Exact|||Display exact confidence limits for relative risk and Fisher's exact test for comparisons of two proportions.||53.9968|0.1866|>0.9999
71032098|NCT00322465|141572884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.005|TWO_SIDED|95.0|0.6|0.91||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for age (per 5 years) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model.||0.91|0.60|0.005
71094518|NCT02260986|141696801|SUPERIORITY|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 16 were considered as non-responders.|difference in percentages|40.8|||<|0.0001|TWO_SIDED|95.0|33.74|47.81||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level for both comparisons.||47.81|33.74|<0.0001
70972765|NCT01926782|141452288|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.5|||<|0.0001|TWO_SIDED|97.5|-45.8|-33.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-33.1|-45.8|<0.0001
70972766|NCT01926782|141452289|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.2|||<|0.0001|TWO_SIDED|97.5|-53.2|-43.2||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-43.2|-53.2|<0.0001
70972767|NCT01926782|141452290|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.5|||<|0.0001|TWO_SIDED|97.5|-49.9|-39.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-39.1|-49.9|<0.0001
70972768|NCT01926782|141452291|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.3|||<|0.0001|TWO_SIDED|97.5|-55.0|-45.6||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-45.6|-55.0|<0.0001
70972769|NCT01926782|141452292|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.0|||<|0.0001|TWO_SIDED|97.5|-49.9|-36.2||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-36.2|-49.9|<0.0001
70972770|NCT01926782|141452293|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.0|||<|0.0001|TWO_SIDED|97.5|-55.3|-44.8||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-44.8|-55.3|<0.0001
70972771|NCT01926782|141452294|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.0|||<|0.0001|TWO_SIDED|97.5|-54.8|-43.3||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-43.3|-54.8|<0.0001
70972772|NCT01926782|141452295|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.8|||<|0.0001|TWO_SIDED|97.5|-57.6|-47.9||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-47.9|-57.6|<0.0001
70972773|NCT01926782|141452296|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.4|||<|0.0001|TWO_SIDED|97.5|-36.6|-26.3||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-26.3|-36.6|<0.0001
70972774|NCT01926782|141452297|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.0|||<|0.0001|TWO_SIDED|97.5|-38.9|-31.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-31.1|-38.9|<0.0001
70972775|NCT01926782|141452298|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.1|||<|0.0001|TWO_SIDED|97.5|-49.0|-39.2||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-39.2|-49.0|<0.0001
71032099|NCT00322465|141572884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.78|TWO_SIDED|95.0|0.33|2.3||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for scant discharge (reference category is no discharge) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model.||2.30|0.33|0.780
71032100|NCT00322465|141572884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0||||0.164|TWO_SIDED|95.0|0.75|5.33||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for moderate discharge amount (reference category is no discharge) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model.||5.33|0.75|0.164
71032101|NCT00322465|141572884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.919|TWO_SIDED|95.0|0.23|5.17||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for large amount of discharge (reference category is no discharge) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multvariable logistic regression model.||5.17|0.23|0.919
71094519|NCT02260986|141696802|SUPERIORITY||difference in percentages|39.1|||<|0.0001|TWO_SIDED|95.0|28.53|49.65||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.||49.65|28.53|<0.0001
70972776|NCT01926782|141452299|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.8|||<|0.0001|TWO_SIDED|97.5|-49.7|-39.9||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-39.9|-49.7|<0.0001
70919954|NCT03482635|141330450|OTHER||Difference of adjusted means|-0.3|STANDARD_ERROR_OF_MEAN|10.7||0.9776|TWO_SIDED|95.0|-21.6|21.0|||Mixed Models Analysis|||Restricted maximum likelihood (REML)-based repeated measures approach. The model included fixed, categorical effects of treatment, visit, and treatment by visit interaction, and stratification factors (prior biologic treatment failure and concomitant corticosteroid therapy at Visit 2/randomisation), as well as the continuous fixed covariates of baseline and baseline-by-visit interaction. An unstructured covariance structure was used to model the within-patient measurements.||21.0|-21.6|0.9776
70919955|NCT03482635|141330450|OTHER||Difference of adjusted means|1.4|STANDARD_ERROR_OF_MEAN|10.6||0.894|TWO_SIDED|95.0|-19.6|22.4|||Mixed Models Analysis|||Restricted maximum likelihood (REML)-based repeated measures approach. The model included fixed, categorical effects of treatment, visit, and treatment by visit interaction, and stratification factors (prior biologic treatment failure and concomitant corticosteroid therapy at Visit 2/randomisation), as well as the continuous fixed covariates of baseline and baseline-by-visit interaction. An unstructured covariance structure was used to model the within-patient measurements.||22.4|-19.6|0.8940
70919956|NCT03482635|141330450|OTHER||Difference of adjusted means|1.0|STANDARD_ERROR_OF_MEAN|10.6||0.9241|TWO_SIDED|95.0|-20.0|22.1|||Mixed Models Analysis|||Restricted maximum likelihood (REML)-based repeated measures approach. The model included fixed, categorical effects of treatment, visit, and treatment by visit interaction, and stratification factors (prior biologic treatment failure and concomitant corticosteroid therapy at Visit 2/randomisation), as well as the continuous fixed covariates of baseline and baseline-by-visit interaction. An unstructured covariance structure was used to model the within-patient measurements||22.1|-20.0|0.9241
70919957|NCT04723394|141330528|SUPERIORITY||Relative Risk Reduction (100*[1-RR])|50.38||||0.01|TWO_SIDED|95.0|14.38|71.25|||Cochran-Mantel-Haenszel|CMH was stratified by randomization factors||AZD7442 vs Placebo||71.25|14.38|0.010
70919958|NCT04723394|141330529|SUPERIORITY||Relative Risk Reduction (100*[1-RR])|49.24||||0.009|TWO_SIDED|95.0|14.72|69.79|||Cochran-Mantel-Haenszel|CMH was stratified by randomization factors||AZD7442 vs Placebo||69.79|14.72|0.009
70919959|NCT00253890|141330533|SUPERIORITY_OR_OTHER||Mean Difference (Net)|35.7||||0.05||95.0|||||t-test, 2 sided|||Change in sleep quality was assessed by calculating gain scores. We used a 2-sided t-test to report mean change.||||.05
70919960|NCT02765100|141330535|EQUIVALENCE|Unless specified otherwise, each of the statistical tests above will use a two-tailed alpha-level of 0.05.|Mean Difference (Final Values)|-0.2|STANDARD_DEVIATION|3.4|<|0.05|TWO_SIDED||||||t-test, 2 sided|||This is a pilot proof of concept study and does not require formal sample size calculations. High and low CRP groups will be compared on demographic, clinical and biological variables using two-sample t-tests or analysis of variance (ANOVA) tests for continuous variables (for nonparametric continuous variables, either Mann-Whitney tests or Kruskal-Wallis tests will be used) and chi-square tests or Fisher's exact tests for categorical variables.||||<0.05
70919961|NCT02652442|141330560|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|Paired samples t-test for change in SVV (measured in degrees)||Null hypothesis: The change in SVV (Post-OAR - Pre-OAR) will not be different for the off-axis distance of 3.5 cm and 7.0 cm.||||0.97
70919962|NCT02652442|141330560|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|Paired samples t-test for change in SVV (measured in degrees)||Null hypothesis: The change in SVV (Post-OAR - Pre-OAR) will not be different for the centrifugation duration of 1 minute and 3 minutes.||||0.51
70919963|NCT02652442|141330560|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|Paired samples t-test for change in SVV (measured in degrees)||Null hypothesis: The change in SVV (Post-OAR - Pre-OAR) will not be different for the centrifugation schedule of daily OAR and biweekly OAR for a total of 5 sessions.||||0.44
70919964|NCT00914589|141330575|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0482||||0.8648||95.0|0.6095|1.8029||P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||1.8029|0.6095|0.8648
70972777|NCT01926782|141452300|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.5|||<|0.0001|TWO_SIDED|97.5|-54.5|-44.6||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-44.6|-54.5|<0.0001
70972778|NCT01926782|141452301|SUPERIORITY_OR_OTHER||LS Mean Difference|-47.1|||<|0.0001|TWO_SIDED|97.5|-52.2|-42.0||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-42.0|-52.2|<0.0001
70972779|NCT01926782|141452302|SUPERIORITY_OR_OTHER||LS Mean Difference|-36.4|||<|0.0001|TWO_SIDED|97.5|-40.4|-32.4||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-32.4|-40.4|<0.0001
70972780|NCT01926782|141452303|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.8|||<|0.0001|TWO_SIDED|97.5|-36.5|-29.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-29.1|-36.5|<0.0001
70972781|NCT01926782|141452304|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|68.0|||<|0.0001|TWO_SIDED|97.5|20.9|221.0||Threshold for significance ≤ 0.025.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by logistic regression model.||221.0|20.9|<0.0001
70972782|NCT01926782|141452305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|25.6|||<|0.0001|TWO_SIDED|97.5|13.7|47.8||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used multiple imputation approach followed by logistic regression model.||47.8|13.7|<0.0001
70919965|NCT00914589|141330575|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9871||||0.9634||95.0|0.5673|1.7176||P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||1.7176|0.5673|0.9634
71032102|NCT00322465|141572884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.051|TWO_SIDED|95.0|1.0|3.3||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for 2 or more sex partners in the last 3 months (reference category is 0-1 partners) is 1 versus the alternative that it is greater than or less than 1.||3.30|1.00|0.051
71032103|NCT00322465|141572884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.42||||0.076|TWO_SIDED|95.0|0.86|22.74||A priori threshold for statistical significance was p\<0.05|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for 1 or more new sex partners in the last 30 days (reference category is 0) is 1 versus the alternative that it is greater than or less than 1.||22.74|0.86|0.076
71032104|NCT00322465|141572884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.38||||0.075|TWO_SIDED|95.0|0.13|1.1||A priori threshold fors tatistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for ever having sex with a prostitute or sex for money, drugs, or other things (reference category is no) is 1 versus the alternative that it is greater than or less than 1.||1.10|0.13|0.075
71094520|NCT02260986|141696802|SUPERIORITY||difference in percentages|31.1|||<|0.0001|TWO_SIDED|95.0|23.84|38.39||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.||38.39|23.84|<0.0001
70919966|NCT01290341|141330580|SUPERIORITY_OR_OTHER||p-value|0.001|||<|0.025||95.0|||||Cochran-Mantel-Haenszel|The CMH test statistic after stratification by site was used to compare subjects with complete cure between NAFT-600 and Placebo.||"In order to compare complete cure rate in the NAFT-600 group with that of the Placebo group, the following one-sided hypothesis test was carried out:~H0 (null): p1\<=p0 versus Ha (alternate): p1\>p0, where p0 and p1 are the proportions of subjects with complete cure in the placebo and NAFT-600 treatment groups respectively."||||<0.025
70919967|NCT01102231|141330592|OTHER||Proportion difference|0.905|||||TWO_SIDED|95.0|0.846|0.964||||||||0.964|0.846|
70919968|NCT03903822|141330595|SUPERIORITY||Least square (LS) mean difference|-13.9|STANDARD_ERROR_OF_MEAN|11.04||0.104|TWO_SIDED|90.0|-32.1|4.3|||ANCOVA|||Analysis of covariance (ANCOVA) contained fixed factors of treatment and baseline value.||4.3|-32.1|0.1040
70919969|NCT03903822|141330595|SUPERIORITY||LS Mean Difference|-20.2|STANDARD_ERROR_OF_MEAN|11.0||0.0334|TWO_SIDED|90.0|-38.3|-2.1|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-2.1|-38.3|0.0334
70919970|NCT03903822|141330595|SUPERIORITY||LS Mean Difference|-25.6|STANDARD_ERROR_OF_MEAN|10.75||0.0086|TWO_SIDED|90.0|-43.3|-8.0|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-8.0|-43.3|0.0086
70919971|NCT03903822|141330595|SUPERIORITY||LS Mean Difference|-23.5|STANDARD_ERROR_OF_MEAN|10.93||0.0158|TWO_SIDED|90.0|-41.5|-5.5|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-5.5|-41.5|0.0158
70919972|NCT03903822|141330595|SUPERIORITY||LS Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|8.11||0.0879|TWO_SIDED|90.0|-24.3|2.4|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||2.4|-24.3|0.0879
70919973|NCT03903822|141330595|SUPERIORITY||LS Mean Difference|-27.4|STANDARD_ERROR_OF_MEAN|8.11||0.0004|TWO_SIDED|90.0|-40.7|-14.1|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-14.1|-40.7|0.0004
70919974|NCT03903822|141330596|SUPERIORITY||Risk Difference (RD)|18.9||||0.0244|TWO_SIDED|90.0|2.4|34.7|||Chan and Zhang Exact Method|||Risk difference = difference in percentage of participants.||34.7|2.4|0.0244
70919975|NCT03903822|141330596|SUPERIORITY||Risk Difference (RD)|22.5||||0.0113|TWO_SIDED|90.0|4.8|38.6|||Chan and Zhang Exact Method|||Risk difference = difference in percentage of participants.||38.6|4.8|0.0113
70919976|NCT03903822|141330596|SUPERIORITY||Risk Difference (RD)|29.7||||0.0018|TWO_SIDED|90.0|11.0|45.7|||Chan and Zhang Exact Method|||Risk difference = difference in percentage of participants.||45.7|11.0|0.0018
70919977|NCT03903822|141330596|SUPERIORITY||Risk Difference (RD)|33.6||||0.0007|TWO_SIDED|90.0|13.7|49.9|||Chan and Zhang Exact Method|||Risk difference = difference in percentage of participants.||49.9|13.7|0.0007
70919978|NCT03903822|141330596|SUPERIORITY||Risk Difference (RD)|19.4||||0.0289|TWO_SIDED|90.0|1.8|36.5|||Chan and Zhang Exact Method|||Risk difference = difference in percentage of participants.||36.5|1.8|0.0289
70919979|NCT03903822|141330596|SUPERIORITY||Risk Difference (RD)|13.1||||0.1145|TWO_SIDED|90.0|-2.9|29.6|||Chan and Zhang Exact Method|||Risk difference = difference in percentage of participants.||29.6|-2.9|0.1145
70919980|NCT03903822|141330597|SUPERIORITY||LS mean difference|-1.31|STANDARD_ERROR_OF_MEAN|0.79||0.0488|TWO_SIDED|90.0|-2.61|-0.01|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-0.01|-2.61|0.0488
70919981|NCT03903822|141330597|SUPERIORITY||LS Mean Difference|-1.37|STANDARD_ERROR_OF_MEAN|0.788||0.0413|TWO_SIDED|90.0|-2.66|-0.07|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-0.07|-2.66|0.0413
70919982|NCT03903822|141330597|SUPERIORITY||LS Mean Difference|-1.59|STANDARD_ERROR_OF_MEAN|0.773||0.02|TWO_SIDED|90.0|-2.86|-0.32|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-0.32|-2.86|0.0200
70919983|NCT03903822|141330597|SUPERIORITY||LS Mean Difference|-2.33|STANDARD_ERROR_OF_MEAN|0.758||0.0011|TWO_SIDED|90.0|-3.58|-1.08|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-1.08|-3.58|0.0011
70919984|NCT03903822|141330597|SUPERIORITY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.535||0.0727|TWO_SIDED|90.0|-1.66|0.1|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||0.10|-1.66|0.0727
70919985|NCT03903822|141330597|SUPERIORITY||LS Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.534||0.001|TWO_SIDED|90.0|-2.52|-0.77|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-0.77|-2.52|0.0010
71094521|NCT02260986|141696803|SUPERIORITY||difference in percentages|37.9|||<|0.0001|TWO_SIDED|95.0|27.56|48.31||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.||48.31|27.56|<0.0001
70972783|NCT01926782|141452306|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|280.2|||<|0.0001|TWO_SIDED|97.5|56.7|1385.7||Threshold for significance ≤ 0.025.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||1385.7|56.7|<0.0001
70972784|NCT01926782|141452307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|41.3|||<|0.0001|TWO_SIDED|97.5|20.3|83.8||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by logistic regression model||83.8|20.3|<0.0001
70972785|NCT01926782|141452308|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|90.6|||<|0.0001|TWO_SIDED|97.5|16.5|498.3||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by logistic regression model.||498.3|16.5|<0.0001
70972786|NCT01926782|141452309|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|49.5|||<|0.0001|TWO_SIDED|97.5|23.4|104.4||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by logistic regression model.||104.4|23.4|<0.0001
70972787|NCT01926782|141452310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|297.1|||<|0.0001|TWO_SIDED|97.5|27.9|3160.6||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used multiple imputation approach followed by logistic regression model.||3160.6|27.9|<0.0001
70972788|NCT01926782|141452311|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|77.7|||<|0.0001|TWO_SIDED|97.5|34.1|176.8||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used multiple imputation approach followed by logistic regression model.||176.8|34.1|<0.0001
70972789|NCT01926782|141452312|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.7|||<|0.0001|TWO_SIDED|97.5|-37.0|-18.3||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-18.3|-37.0|<0.0001
70972790|NCT01926782|141452313|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-29.1|||<|0.0001|TWO_SIDED|97.5|-35.5|-22.7||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-22.7|-35.5|<0.0001
70972791|NCT01926782|141452314|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-23.5|||<|0.0001|TWO_SIDED|97.5|-32.4|-14.5||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-14.5|-32.4|<0.0001
70972792|NCT01926782|141452315|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-26.6|||<|0.0001|TWO_SIDED|97.5|-32.8|-20.4||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-20.4|-32.8|<0.0001
71094522|NCT02260986|141696803|SUPERIORITY||difference in percentages|34.7|||<|0.0001|TWO_SIDED|95.0|27.31|42.05||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.||42.05|27.31|<0.0001
70972793|NCT01926782|141452316|SUPERIORITY_OR_OTHER||LS Mean Difference|7.8||||0.0003|TWO_SIDED|97.5|3.1|12.6||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||12.6|3.1|0.0003
70972794|NCT01926782|141452317|SUPERIORITY_OR_OTHER||LS Mean Difference|5.1||||0.0004|TWO_SIDED|97.5|1.9|8.4||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||8.4|1.9|0.0004
70972795|NCT01926782|141452318|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9||||0.0004|TWO_SIDED|97.5|2.6|11.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant)||11.1|2.6|0.0004
70972796|NCT01926782|141452319|SUPERIORITY_OR_OTHER||LS Mean Difference|5.2||||0.0007|TWO_SIDED|97.5|1.8|8.7||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||8.7|1.8|0.0007
70919986|NCT03903822|141330598|SUPERIORITY||Risk Difference (RD)|0.5||||0.5246|TWO_SIDED|90.0|-14.7|16.4|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||16.4|-14.7|0.5246
70919987|NCT03903822|141330598|SUPERIORITY||Risk Difference (RD)|3.8||||0.3906|TWO_SIDED|90.0|-12.5|19.9|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||19.9|-12.5|0.3906
70919988|NCT03903822|141330598|SUPERIORITY||Risk Difference (RD)|13.5||||0.1193|TWO_SIDED|90.0|-3.2|30.6|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||30.6|-3.2|0.1193
70919989|NCT03903822|141330598|SUPERIORITY||Risk Difference (RD)|28.2||||0.0048|TWO_SIDED|90.0|8.8|45.5|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||45.5|8.8|0.0048
70919990|NCT03903822|141330598|SUPERIORITY||Risk Difference (RD)|14.7||||0.0777|TWO_SIDED|90.0|-2.0|31.1|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||31.1|-2.0|0.0777
70919991|NCT03903822|141330598|SUPERIORITY||Risk Difference (RD)|11.8||||0.1245|TWO_SIDED|90.0|-4.3|28.0|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||28.0|-4.3|0.1245
70919992|NCT03903822|141330598|SUPERIORITY||Risk Difference (RD)|6.2||||0.3322|TWO_SIDED|90.0|-12.2|24.4|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||24.4|-12.2|0.3322
70919993|NCT03903822|141330598|SUPERIORITY||Risk Difference (RD)|18.5||||0.0535|TWO_SIDED|90.0|-0.3|36.5|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||36.5|-0.3|0.0535
70919994|NCT03903822|141330598|SUPERIORITY||Risk Difference (RD)|24.3||||0.0159|TWO_SIDED|90.0|4.5|41.9|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||41.9|4.5|0.0159
70919995|NCT03903822|141330598|SUPERIORITY||Risk Difference (RD)|36.8||||0.0008|TWO_SIDED|90.0|15.4|54.0|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||54.0|15.4|0.0008
70919996|NCT03903822|141330598|SUPERIORITY||Risk Difference (RD)|20.7||||0.0386|TWO_SIDED|90.0|1.5|38.8|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||38.8|1.5|0.0386
70919997|NCT03903822|141330598|SUPERIORITY||Risk Difference (RD)|12.1||||0.1485|TWO_SIDED|90.0|-6.4|30.3|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||30.3|-6.4|0.1485
70919998|NCT03903822|141330598|SUPERIORITY||Risk Difference (RD)|17.3||||0.062|TWO_SIDED|90.0|-0.8|34.8|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||34.8|-0.8|0.0620
70919999|NCT03903822|141330598|SUPERIORITY||Risk Difference (RD)|26.9||||0.0089|TWO_SIDED|90.0|6.5|44.4|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||44.4|6.5|0.0089
71032105|NCT00322465|141572884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.92|||<|0.001|TWO_SIDED|95.0|1.93|7.98||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for visit due to sexually transmitted disease contact (reference category is no) is 1 versus the alternative that it is greater than or less than 1.||7.98|1.93|<0.001
70920000|NCT03903822|141330598|SUPERIORITY||Risk Difference (RD)|37.8||||0.0005|TWO_SIDED|90.0|17.5|54.7|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||54.7|17.5|0.0005
70920001|NCT03903822|141330598|SUPERIORITY||Risk Difference (RD)|36.7||||0.0007|TWO_SIDED|90.0|15.4|54.0|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||54.0|15.4|0.0007
70920002|NCT03903822|141330598|SUPERIORITY||Risk Difference (RD)|18.1||||0.0711|TWO_SIDED|90.0|-2.0|37.5|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||37.5|-2.0|0.0711
70920003|NCT03903822|141330598|SUPERIORITY||Risk Difference (RD)|23.8||||0.0266|TWO_SIDED|90.0|2.7|42.5|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||42.5|2.7|0.0266
70920004|NCT03903822|141330598|SUPERIORITY||Risk Difference (RD)|3.8||||0.4173|TWO_SIDED|90.0|-15.3|23.1|||Chan and Zhang Exact Method|||At week 4: Risk difference = difference in percentage of participants.||23.1|-15.3|0.4173
70920005|NCT03903822|141330598|SUPERIORITY||Risk Difference (RD)|16.3||||0.1096|TWO_SIDED|90.0|-4.3|35.6|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||35.6|-4.3|0.1096
70920006|NCT03903822|141330598|SUPERIORITY||Risk Difference (RD)|27.0||||0.0133|TWO_SIDED|90.0|6.1|45.7|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||45.7|6.1|0.0133
70920007|NCT03903822|141330598|SUPERIORITY||Risk Difference (RD)|23.2||||0.0304|TWO_SIDED|90.0|2.6|41.7|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||41.7|2.6|0.0304
70920008|NCT03903822|141330598|SUPERIORITY||Risk Difference (RD)|29.4||||0.0078|TWO_SIDED|90.0|7.2|47.6|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||47.6|7.2|0.0078
70920009|NCT03903822|141330598|SUPERIORITY||Risk Difference (RD)|29.4||||0.0078|TWO_SIDED|90.0|7.2|47.6|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||47.6|7.2|0.0078
70920010|NCT03903822|141330598|SUPERIORITY||Risk Difference (RD)|1.1||||0.4966|TWO_SIDED|90.0|-18.4|20.4|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||20.4|-18.4|0.4966
70920011|NCT03903822|141330598|SUPERIORITY||Risk Difference (RD)|10.9||||0.2753|TWO_SIDED|90.0|-9.3|30.1|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||30.1|-9.3|0.2753
70920012|NCT03903822|141330598|SUPERIORITY||Risk Difference (RD)|16.2||||0.1036|TWO_SIDED|90.0|-4.2|35.7|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||35.7|-4.2|0.1036
70920013|NCT03903822|141330598|SUPERIORITY||Risk Difference (RD)|20.6||||0.0457|TWO_SIDED|90.0|0.4|39.6|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||39.6|0.4|0.0457
71032106|NCT00322465|141572885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.2||||0.009|TWO_SIDED|95.0|0.06|0.66||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for 2 or more sex partners in the last 3 months (reference category is 0-1 partners) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model.||0.66|0.06|0.009
71032107|NCT00322465|141572885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39||||0.074|TWO_SIDED|95.0|0.92|6.22||A priori threshold for statistical signficance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for ever having sex with a prostitute or for money, drugs, or other things(reference category is no) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model.||6.22|0.92|0.074
71032108|NCT00322465|141572886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.032|TWO_SIDED|95.0|0.66|0.98||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|No other independent variables were included in the model.||The null hypothesis is that the odds ratio for age (per 5 years) is 1 versus the alternative that the odds ratio is greater than or less than 1.||0.98|0.66|0.032
71032109|NCT01073657|141572892|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.0|STANDARD_DEVIATION|33.9||0.0059|TWO_SIDED|95.0|14.0|38.0|||t-test, 2 sided|||||38|14|0.0059
71032110|NCT01790581|141572893|SUPERIORITY_OR_OTHER|||||||0.904|TWO_SIDED||||||MANOVA|||This analysis examined the change in balance scores from baseline to 1-day post intervention for all three reach distances (Anterior, Posteriomedial, Posteriolateral) using a MANOVA.||||.904
71032111|NCT01790581|141572895|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||MANOVA|||This analysis examined the change in disability scores from baseline to 1-day post intervention for both disability scores (FAAM, FAAM-S) using a MANOVA.||||.5
71032112|NCT00762307|141572941|OTHER||Mean Difference (Net)|18.7|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|95.0|14.9|22.4||||||||22.4|14.9|
71032113|NCT00762307|141572943|OTHER||sucess percentage|91.9|STANDARD_ERROR_OF_MEAN|5.2|||ONE_SIDED|||||||||||||
71032114|NCT02779543|141572944|EQUIVALENCE|this trial compared the 2 devices to the polysomnography, which is the gold standard|Mean value|368.3|||<|0.001|TWO_SIDED||||||ANOVA||compared to gold standard|||||<0.001
71032115|NCT02779543|141572945|EQUIVALENCE|This trial compared those 2 devices with the gold standard (polysomnography)|Mean value|13.9|||<|0.001|TWO_SIDED||||||ANOVA||compared to gold standard|||||<0.001
71094523|NCT02260986|141696804|SUPERIORITY||difference in percentages|23.5|||<|0.0001|TWO_SIDED|95.0|12.72|34.19||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 52 were considered as non-responders.||34.19|12.72|<0.0001
71094524|NCT02260986|141696804|SUPERIORITY||difference in percentages|27.5|||<|0.0001|TWO_SIDED|95.0|20.42|34.58||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 52 were considered as non-responders.||34.58|20.42|<0.0001
70920014|NCT03903822|141330598|SUPERIORITY||Risk Difference (RD)|29.4||||0.0078|TWO_SIDED|90.0|7.2|47.6|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||47.6|7.2|0.0078
70920015|NCT03903822|141330598|SUPERIORITY||Risk Difference (RD)|29.4||||0.0078|TWO_SIDED|90.0|7.2|47.6|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||47.6|7.2|0.0078
70920016|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|3.3||||0.245|TWO_SIDED|90.0|-5.4|14.9|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||14.9|-5.4|0.2450
70920017|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|3.1||||0.2575|TWO_SIDED|90.0|-5.3|14.0|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||14.0|-5.3|0.2575
70920018|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|16.1||||0.0087|TWO_SIDED|90.0|5.7|31.0|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||31.0|5.7|0.0087
70920019|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|10.7||||0.0392|TWO_SIDED|90.0|0.8|25.4|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||25.4|0.8|0.0392
70920020|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|90.0|-11.2|11.2|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||11.2|-11.2|1.0000
70920021|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|7.8||||0.1528|TWO_SIDED|90.0|-4.9|22.5|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||22.5|-4.9|0.1528
70920022|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|0.9||||0.4989|TWO_SIDED|90.0|-12.7|15.2|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||15.2|-12.7|0.4989
70920023|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|0.3||||0.5419|TWO_SIDED|90.0|-13.6|14.2|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||14.2|-13.6|0.5419
71032116|NCT02779543|141572946|EQUIVALENCE|This trial compared those 2 devices with the gold standard (polysomnography)|Mean value|106.0|||<|0.001|TWO_SIDED||||||ANOVA||compared to gold standard|||||<0.001
71032117|NCT02779543|141572947|EQUIVALENCE|This trial compared those 2 devices with the gold standard (polysomnography)|Mean value|74.3|||<|0.001|TWO_SIDED||||||ANOVA||compared to gold standard|||||<0.001
71032118|NCT03707912|141572974|SUPERIORITY|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
71032119|NCT03707912|141572975|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
70972797|NCT01926782|141452320|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-11.9||||0.0042|TWO_SIDED|97.5|-21.3|-2.6||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-2.6|-21.3|0.0042
71094525|NCT02260986|141696805|SUPERIORITY||difference in percentages|43.6|||<|0.0001|TWO_SIDED|95.0|32.5|54.65||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 52 were considered as non-responders.||54.65|32.50|<0.0001
70972798|NCT01926782|141452321|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-15.1|||<|0.0001|TWO_SIDED|97.5|-21.5|-8.6||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-8.6|-21.5|<0.0001
70972799|NCT01926782|141452322|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-14.1||||0.0004|TWO_SIDED|97.5|-22.9|-5.2||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-5.2|-22.9|0.0004
71032120|NCT03707912|141572976|SUPERIORITY|||||||0.0012|||||||Cochran-Mantel-Haenszel|||||||0.0012
70972800|NCT01926782|141452323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-13.6|||<|0.0001|TWO_SIDED|97.5|-20.3|-6.9||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-6.9|-20.3|<0.0001
70972801|NCT01926782|141452324|SUPERIORITY_OR_OTHER||LS Mean Difference|6.6|||<|0.0001|TWO_SIDED|97.5|3.0|10.2||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||10.2|3.0|<0.0001
70972802|NCT01926782|141452325|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7||||0.0306|TWO_SIDED|97.5|-0.1|5.4||Threshold for significance ≤ 0.025.|Mixed Models Analysis||Alirocumab 300 mg vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.4|-0.1|0.0306
70972803|NCT03850912|141452343|SUPERIORITY||Odds Ratio (OR)|1.104||||0.214|TWO_SIDED|95.0|0.944|1.29|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (chemo and surgical patients combined)||1.290|0.944|0.214
70972804|NCT03850912|141452343|SUPERIORITY||Odds Ratio (OR)|0.927||||0.565|TWO_SIDED|95.0|0.715|1.201|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology patients only)||1.201|0.715|0.565
70972805|NCT03850912|141452343|SUPERIORITY||Odds Ratio (OR)|1.225||||0.042|TWO_SIDED|95.0|1.008|1.49|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (surgical patients only)||1.490|1.008|0.042
70972806|NCT03850912|141452344|OTHER||Odds Ratio (OR)|1.128||||0.05|TWO_SIDED|95.0|1.0|1.272|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology and surgical patients combined)||1.272|1.000|0.050
70972807|NCT03850912|141452344|OTHER||Odds Ratio (OR)|1.012||||0.903|TWO_SIDED|95.0|0.836|1.225|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology patients only)||1.225|0.836|0.903
70972808|NCT03850912|141452344|OTHER||Odds Ratio (OR)|1.215||||0.014|TWO_SIDED|95.0|1.04|1.418|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (surgical patients only)||1.418|1.040|0.014
70972809|NCT03850912|141452345|OTHER||Odds Ratio (OR)|1.002||||0.978|TWO_SIDED|95.0|0.881|1.139|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology and surgical patients combined)||1.139|0.881|0.978
70972810|NCT03850912|141452345|OTHER||Odds Ratio (OR)|0.854||||0.126|TWO_SIDED|95.0|0.697|1.046|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology patients only)||1.046|0.697|0.126
70972811|NCT03850912|141452345|OTHER||Odds Ratio (OR)|1.102||||0.254|TWO_SIDED|95.0|0.933|1.302|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (surgical patients only)||1.302|0.933|0.254
70972812|NCT03850912|141452346|OTHER||Odds Ratio (OR)|1.068||||0.209|TWO_SIDED|95.0|0.964|1.183|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology and surgical patients combined)||1.183|0.964|0.209
70972813|NCT03850912|141452346|OTHER||Odds Ratio (OR)|0.992||||0.924|TWO_SIDED|95.0|0.85|1.159|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology patients only)||1.159|0.850|0.924
70972814|NCT03850912|141452346|OTHER||Odds Ratio (OR)|1.122||||0.099|TWO_SIDED|95.0|0.979|1.286|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (surgical patients only)||1.286|0.979|0.099
70972815|NCT03850912|141452347|SUPERIORITY||Difference|-1.328||||0.04|TWO_SIDED|95.0|-2.593|-0.062|||Regression, Linear|||Multivariable regression analyses (medical oncology cohort only)||-0.062|-2.593|0.04
70972816|NCT03850912|141452347|OTHER||Difference|-1.958||||0.004|TWO_SIDED|95.0|-3.269|-0.646|||Regression, Logistic|||Multivariable regression analyses (surgical cohort only)||-0.646|-3.269|0.004
70972817|NCT03850912|141452348|SUPERIORITY||Difference|-0.925||||0.09|TWO_SIDED|95.0|-1.985|0.136|||Regression, Linear|||Multivariable regression analyses (medical oncology cohort only)||0.136|-1.985|0.09
70972818|NCT03850912|141452348|SUPERIORITY||Difference|-1.516||||0.002|TWO_SIDED|95.0|-2.474|-0.557|||Regression, Linear|||Multivariable regression analyses (surgical cohort only)||-0.557|-2.474|0.002
71032121|NCT03707912|141572976|OTHER|Test for assessing the homogeneity of the odds ratio in several 2 × 2 contingency tables.||||||0.98|||||||Breslow-Day test|||||||0.98
71032122|NCT03707912|141572977|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
71094526|NCT02260986|141696805|SUPERIORITY||difference in percentages|42.5|||<|0.0001|TWO_SIDED|95.0|34.91|50.06||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 52 were considered as non-responders.||50.06|34.91|<0.0001
70920024|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|10.3||||0.1362|TWO_SIDED|90.0|-5.0|26.2|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||26.2|-5.0|0.1362
70920025|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|15.9||||0.0541|TWO_SIDED|90.0|-0.4|33.9|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||33.9|-0.4|0.0541
70920026|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|3.3||||0.3945|TWO_SIDED|90.0|-12.0|19.5|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||19.5|-12.0|0.3945
70920027|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|23.3||||0.0201|TWO_SIDED|90.0|3.9|41.8|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||41.8|3.9|0.0201
70920028|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|11.2||||0.1372|TWO_SIDED|90.0|-5.4|28.2|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||28.2|-5.4|0.1372
70920029|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|3.5||||0.3924|TWO_SIDED|90.0|-11.6|19.1|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||19.1|-11.6|0.3924
70920030|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|20.1||||0.0311|TWO_SIDED|90.0|2.4|38.3|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||38.3|2.4|0.0311
70972819|NCT03850912|141452349|SUPERIORITY||Difference|-1.767||||0.17|TWO_SIDED|95.0|-2.532|0.433|||Regression, Linear|||Multivariable regression analyses (medical oncology cohort only)||0.433|-2.532|0.17
70972820|NCT03850912|141452349|SUPERIORITY||Difference|-2.198|||<|0.0001|TWO_SIDED|95.0|-3.259|-1.137|||Regression, Linear|||Multivariable regression analyses (surgical cohort only)||-1.137|-3.259|<0.0001
70972821|NCT03850912|141452350|SUPERIORITY||Difference|-0.8084||||0.2|TWO_SIDED|95.0|-2.048|0.431|||Regression, Linear|||Multivariable regression analyses (medical oncology cohort only)||0.431|-2.048|0.2
70972822|NCT03850912|141452350|SUPERIORITY||Difference|-0.652||||0.27|TWO_SIDED|95.0|-1.8|0.496|||Regression, Linear|||Multivariable regression analyses (surgical cohort only)||0.496|-1.800|0.27
70972823|NCT03850912|141452351|SUPERIORITY||Difference|-0.617||||0.23|TWO_SIDED|95.0|-1.62|0.386|||Regression, Linear|||Multivariable regression analyses (medical oncology cohort only)||0.386|-1.620|0.23
71094527|NCT02260986|141696806|SUPERIORITY||Least square (LS) mean difference|-26.2|||<|0.0001|TWO_SIDED|95.0|-35.04|-17.43||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-17.43|-35.04|<0.0001
70920031|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|20.0||||0.0392|TWO_SIDED|90.0|0.8|38.1|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||38.1|0.8|0.0392
70920032|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|10.0||||0.1541|TWO_SIDED|90.0|-6.2|26.4|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||26.4|-6.2|0.1541
70920033|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|27.0||||0.0091|TWO_SIDED|90.0|6.8|45.4|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||45.4|6.8|0.0091
70920034|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|8.5||||0.2835|TWO_SIDED|90.0|-9.5|27.0|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||27.0|-9.5|0.2835
70920035|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|9.9||||0.27|TWO_SIDED|90.0|-8.7|27.8|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||27.8|-8.7|0.2700
70920036|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|17.3||||0.0662|TWO_SIDED|90.0|-1.4|36.2|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||36.2|-1.4|0.0662
70920037|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|31.8||||0.005|TWO_SIDED|90.0|9.2|50.4|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||50.4|9.2|0.0050
70972824|NCT03850912|141452351|SUPERIORITY||Difference|0.434||||0.39|TWO_SIDED|95.0|-0.563|1.431|||Regression, Linear|||Multivariable regression analyses (surgical cohort only)||1.431|-0.563|0.39
70972825|NCT03850912|141452352|SUPERIORITY||Difference|-0.7||||0.22|TWO_SIDED|95.0|-1.829|0.429|||Regression, Linear|||Multivariable regression analyses (medical oncology cohort only)||0.429|-1.829|0.22
70972826|NCT03850912|141452352|SUPERIORITY||Difference|-0.58||||0.28|TWO_SIDED|95.0|-1.632|0.472|||Regression, Linear|||Multivariable regression analyses (surgical cohort only)||0.472|-1.632|0.28
70972827|NCT03850912|141452353|SUPERIORITY||Odds Ratio (OR)|0.842|||<|0.001|TWO_SIDED|95.0|0.776|0.913|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (chemo and surgical patients combined)||0.913|0.776|<0.001
70972828|NCT03850912|141452353|SUPERIORITY||Odds Ratio (OR)|0.78|||<|0.001|TWO_SIDED|95.0|0.688|0.885|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology patients only)||0.885|0.688|<0.001
70972829|NCT03850912|141452353|SUPERIORITY||Odds Ratio (OR)|0.889||||0.032|TWO_SIDED|95.0|0.799|0.99|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (surgical patients only)||0.990|0.799|0.032
70972830|NCT03850912|141452354|SUPERIORITY||Odds Ratio (OR)|0.893|||<|0.001|TWO_SIDED|95.0|0.839|0.949|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology and surgical patients combined)||0.949|0.839|<0.001
70972831|NCT03850912|141452354|SUPERIORITY||Odds Ratio (OR)|0.872||||0.003|TWO_SIDED|95.0|0.796|0.954|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology patients only)||0.954|0.796|0.003
71032123|NCT03707912|141572978|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71094528|NCT02260986|141696806|SUPERIORITY||LS mean difference|-26.8|||<|0.0001|TWO_SIDED|95.0|-32.83|-20.73||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-20.73|-32.83|<0.0001
70920038|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|20.0||||0.0302|TWO_SIDED|90.0|2.2|38.3|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||38.3|2.2|0.0302
70920039|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|27.0||||0.0091|TWO_SIDED|90.0|6.8|45.4|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||45.4|6.8|0.0091
70920040|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|11.8||||0.1561|TWO_SIDED|90.0|-6.5|30.2|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||30.2|-6.5|0.1561
70920041|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|16.2||||0.0753|TWO_SIDED|90.0|-2.7|34.8|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||34.8|-2.7|0.0753
70920042|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|27.0||||0.0108|TWO_SIDED|90.0|5.7|46.0|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||46.0|5.7|0.0108
70920043|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|31.8||||0.005|TWO_SIDED|90.0|9.2|50.4|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||50.4|9.2|0.0050
70920044|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|16.7||||0.0775|TWO_SIDED|90.0|-2.9|35.7|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||35.7|-2.9|0.0775
70920045|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|24.1||||0.0243|TWO_SIDED|90.0|3.4|43.4|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||43.4|3.4|0.0243
70920046|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|20.9||||0.0234|TWO_SIDED|90.0|3.5|38.8|||Chan and Zhang Exact Method|||At follow-up visit: Risk difference = difference in percentage of participants.||38.8|3.5|0.0234
70920047|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|12.8||||0.1134|TWO_SIDED|90.0|-2.8|29.3|||Chan and Zhang Exact Method|||At follow-up visit: Risk difference = difference in percentage of participants.||29.3|-2.8|0.1134
70920048|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|10.3||||0.1362|TWO_SIDED|90.0|-5.0|26.2|||Chan and Zhang Exact Method|||At follow-up visit: Risk difference = difference in percentage of participants.||26.2|-5.0|0.1362
70920049|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|12.3||||0.1029|TWO_SIDED|90.0|-3.4|29.8|||Chan and Zhang Exact Method|||At follow-up visit: Risk difference = difference in percentage of participants.||29.8|-3.4|0.1029
71032124|NCT03707912|141572978|OTHER|Test for assessing the homogeneity of the odds ratio in several 2 × 2 contingency tables.||||||0.75|||||||Breslow-Day test|||||||0.75
70920050|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|90.0|-17.9|17.9|||Chan and Zhang Exact Method|||At follow-up visit: Risk difference = difference in percentage of participants.||17.9|-17.9|1.0000
70920051|NCT03903822|141330599|SUPERIORITY||Risk Difference (RD)|-12.6||||0.8972|TWO_SIDED|90.0|-28.8|3.5|||Chan and Zhang Exact Method|||At follow-up visit: Risk difference = difference in percentage of participants.||3.5|-28.8|0.8972
70920052|NCT03903822|141330600|SUPERIORITY||LS Mean difference|-0.5|STANDARD_ERROR_OF_MEAN|8.33||0.4781|TWO_SIDED|90.0|-14.2|13.3|||Mixed Model Repeated Measure|||At Week 1: Mixed Model Repeated Measure (MMRM) contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||13.3|-14.2|0.4781
70920053|NCT03903822|141330600|SUPERIORITY||LS Mean difference|-13.8|STANDARD_ERROR_OF_MEAN|8.47||0.0522|TWO_SIDED|90.0|-27.8|0.2|||Mixed Model Repeated Measure|||At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||0.2|-27.8|0.0522
70920054|NCT03903822|141330600|SUPERIORITY||LS Mean difference|-17.5|STANDARD_ERROR_OF_MEAN|8.37||0.0187|TWO_SIDED|90.0|-31.4|-3.7|||Mixed Model Repeated Measure|||At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-3.7|-31.4|0.0187
70920055|NCT03903822|141330600|SUPERIORITY||LS Mean difference|-20.6|STANDARD_ERROR_OF_MEAN|8.45||0.008|TWO_SIDED|90.0|-34.5|-6.6|||Mixed Model Repeated Measure|||At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-6.6|-34.5|0.0080
70920056|NCT03903822|141330600|SUPERIORITY||LS Mean difference|-25.0|STANDARD_ERROR_OF_MEAN|14.17||0.0401|TWO_SIDED|90.0|-48.6|-1.5|||Mixed Model Repeated Measure|||At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-1.5|-48.6|0.0401
70920057|NCT03903822|141330600|SUPERIORITY||LS Mean difference|-25.5|STANDARD_ERROR_OF_MEAN|14.25||0.0379|TWO_SIDED|90.0|-49.2|-1.9|||Mixed Model Repeated Measure|||At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-1.9|-49.2|0.0379
70920058|NCT03903822|141330600|SUPERIORITY||LS Mean difference|8.1|STANDARD_ERROR_OF_MEAN|11.01||0.7678|TWO_SIDED|90.0|-10.1|26.3|||Mixed Model Repeated Measure|||At Week 2: MMRM contained fixed factors of treatment, visit(Weeks 1, 2, 3, 4, 6 and follow up), treatment-by-visit interaction and baseline value.||26.3|-10.1|0.7678
71032125|NCT03707912|141572979|SUPERIORITY|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||Day 1 comparison.||||0.89
71032126|NCT03707912|141572979|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Day 2 comparison.||||0.75
71032127|NCT03707912|141572979|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Day 3 comparison.||||0.34
71032128|NCT03707912|141572980|SUPERIORITY|||||||0.75|||||||Fisher Exact|||||||0.75
71032129|NCT01811953|141573007|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|102.55|STANDARD_ERROR_OF_MEAN|1.017|<|0.0001|TWO_SIDED|90.0|99.531|105.653|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.|||105.653|99.531|<0.0001
70972832|NCT03850912|141452354|SUPERIORITY||Odds Ratio (OR)|0.909||||0.027|TWO_SIDED|95.0|0.835|0.989|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (surgical patients only)||0.989|0.835|0.027
71032130|NCT01811953|141573007|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|98.88|STANDARD_ERROR_OF_MEAN|1.024|<|0.0001|TWO_SIDED|90.0|94.879|103.059|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.|||103.059|94.879|<0.0001
71094529|NCT02260986|141696807|SUPERIORITY||difference in percentages|38.3|||<|0.0001|TWO_SIDED|95.0|26.96|49.66||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 52 were considered as non-responders.||49.66|26.96|<0.0001
70920059|NCT03903822|141330600|SUPERIORITY||LS Mean difference|-22.8|STANDARD_ERROR_OF_MEAN|10.94||0.0193|TWO_SIDED|90.0|-40.9|-4.7|||Mixed Model Repeated Measure|||At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-4.7|-40.9|0.0193
70920060|NCT03903822|141330600|SUPERIORITY||LS Mean difference|-28.3|STANDARD_ERROR_OF_MEAN|10.95||0.0052|TWO_SIDED|90.0|-46.5|-10.2|||Mixed Model Repeated Measure|||At Week 2:MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-10.2|-46.5|0.0052
70920061|NCT03903822|141330600|SUPERIORITY||LS Mean difference|-23.7|STANDARD_ERROR_OF_MEAN|11.03||0.0164|TWO_SIDED|90.0|-42.0|-5.5|||Mixed Model Repeated Measure|||At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-5.5|-42.0|0.0164
70920062|NCT03903822|141330600|SUPERIORITY||LS Mean difference|-31.7|STANDARD_ERROR_OF_MEAN|9.72||0.0008|TWO_SIDED|90.0|-47.8|-15.6|||Mixed Model Repeated Measure|||At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-15.6|-47.8|0.0008
70920063|NCT03903822|141330600|SUPERIORITY||LS Mean difference|-40.6|STANDARD_ERROR_OF_MEAN|9.86|<|0.0001|TWO_SIDED|90.0|-57.0|-24.3|||Mixed Model Repeated Measure|||At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-24.3|-57.0|<0.0001
70920064|NCT03903822|141330600|SUPERIORITY||LS Mean difference|3.9|STANDARD_ERROR_OF_MEAN|12.09||0.6269|TWO_SIDED|90.0|-16.1|23.9|||Mixed Model Repeated Measure|||At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||23.9|-16.1|0.6269
70920065|NCT03903822|141330600|SUPERIORITY||LS Mean difference|-33.5|STANDARD_ERROR_OF_MEAN|11.87||0.0027|TWO_SIDED|90.0|-53.1|-13.8|||Mixed Model Repeated Measure|||At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-13.8|-53.1|0.0027
70920066|NCT03903822|141330600|SUPERIORITY||LS Mean difference|-38.8|STANDARD_ERROR_OF_MEAN|11.89||0.0007|TWO_SIDED|90.0|-58.5|-19.2|||Mixed Model Repeated Measure|||At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-19.2|-58.5|0.0007
70920067|NCT03903822|141330600|SUPERIORITY||LS Mean difference|-32.1|STANDARD_ERROR_OF_MEAN|12.0||0.0041|TWO_SIDED|90.0|-51.9|-12.3|||Mixed Model Repeated Measure|||At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-12.3|-51.9|0.0041
70920068|NCT03903822|141330600|SUPERIORITY||LS Mean difference|-14.6|STANDARD_ERROR_OF_MEAN|11.61||0.1054|TWO_SIDED|90.0|-33.9|4.6|||Mixed Model Repeated Measure|||At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||4.6|-33.9|0.1054
70920069|NCT03903822|141330600|SUPERIORITY||LS Mean difference|-18.8|STANDARD_ERROR_OF_MEAN|11.62||0.0542|TWO_SIDED|90.0|-38.1|0.5|||Mixed Model Repeated Measure|||At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||0.5|-38.1|0.0542
70920070|NCT03903822|141330600|SUPERIORITY||LS Mean difference|5.8|STANDARD_ERROR_OF_MEAN|12.12||0.6847|TWO_SIDED|90.0|-14.2|25.9|||Mixed Model Repeated Measure|||At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||25.9|-14.2|0.6847
70972833|NCT03850912|141452355|SUPERIORITY||Odds Ratio (OR)|0.636|||<|0.001|TWO_SIDED|95.0|0.593|0.682|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology and surgical patients combined)||0.682|0.593|<0.001
70972834|NCT03850912|141452355|SUPERIORITY||Odds Ratio (OR)|0.611|||<|0.001|TWO_SIDED|95.0|0.55|0.679|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology patients only)||0.679|0.550|<0.001
70920071|NCT03903822|141330600|SUPERIORITY||LS Mean difference|-29.9|STANDARD_ERROR_OF_MEAN|11.82||0.0062|TWO_SIDED|90.0|-49.4|-10.3|||Mixed Model Repeated Measure|||At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-10.3|-49.4|0.0062
70920072|NCT03903822|141330600|SUPERIORITY||LS Mean difference|-32.0|STANDARD_ERROR_OF_MEAN|11.89||0.004|TWO_SIDED|90.0|-51.6|-12.3|||Mixed Model Repeated Measure|||At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-12.3|-51.6|0.0040
70920073|NCT03903822|141330600|SUPERIORITY||LS Mean difference|-30.8|STANDARD_ERROR_OF_MEAN|11.97||0.0054|TWO_SIDED|90.0|-50.6|-11.0|||Mixed Model Repeated Measure|||At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-11.0|-50.6|0.0054
70972835|NCT03850912|141452355|SUPERIORITY||Odds Ratio (OR)|0.655|||<|0.001|TWO_SIDED|95.0|0.597|0.719|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (surgical patients only)||0.719|0.597|<0.001
70972836|NCT03850912|141452356|SUPERIORITY||Odds Ratio (OR)|0.769|||<|0.001|TWO_SIDED|95.0|0.729|0.811|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology and surgical patients combined)||0.811|0.729|<0.001
70972837|NCT03850912|141452356|SUPERIORITY||Odds Ratio (OR)|0.795|||<|0.001|TWO_SIDED|95.0|0.737|0.858|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology patients only)||0.858|0.737|<0.001
70920074|NCT03903822|141330600|SUPERIORITY||LS Mean difference|-11.7|STANDARD_ERROR_OF_MEAN|9.35||0.1076|TWO_SIDED|90.0|-27.2|3.9|||Mixed Model Repeated Measure|||At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||3.9|-27.2|0.1076
70920075|NCT03903822|141330600|SUPERIORITY||LS Mean difference|-23.0|STANDARD_ERROR_OF_MEAN|9.42||0.0082|TWO_SIDED|90.0|-38.6|-7.3|||Mixed Model Repeated Measure|||At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-7.3|-38.6|0.0082
70920076|NCT03903822|141330600|SUPERIORITY||LS Mean difference|-17.8|STANDARD_ERROR_OF_MEAN|14.14||0.1051|TWO_SIDED|90.0|-41.2|5.6|||Mixed Model Repeated Measure|||At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||5.6|-41.2|0.1051
70920077|NCT03903822|141330600|SUPERIORITY||LS Mean difference|-37.8|STANDARD_ERROR_OF_MEAN|13.8||0.0034|TWO_SIDED|90.0|-60.6|-15.0|||Mixed Model Repeated Measure|||At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-15.0|-60.6|0.0034
70920078|NCT03903822|141330600|SUPERIORITY||LS Mean difference|-41.9|STANDARD_ERROR_OF_MEAN|13.83||0.0014|TWO_SIDED|90.0|-64.8|-19.0|||Mixed Model Repeated Measure|||At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-19.0|-64.8|0.0014
70920079|NCT03903822|141330600|SUPERIORITY||LS Mean difference|-38.6|STANDARD_ERROR_OF_MEAN|13.9||0.003|TWO_SIDED|90.0|-61.6|-15.6|||Mixed Model Repeated Measure|||At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-15.6|-61.6|0.0030
70920080|NCT03903822|141330600|SUPERIORITY||LS Mean difference|-17.7|STANDARD_ERROR_OF_MEAN|9.22||0.0289|TWO_SIDED|90.0|-33.0|-2.4|||Mixed Model Repeated Measure|||At Week 6: MMRM contained fixed factors of treatment, visit(Weeks 1, 2, 3, 4, 6 and follow up), treatment-by-visit interaction and baseline value.||-2.4|-33.0|0.0289
71032131|NCT01811953|141573007|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|106.0|STANDARD_ERROR_OF_MEAN|1.018|<|0.0001|TWO_SIDED|90.0|102.728|109.386|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.|||109.386|102.728|<0.0001
70920081|NCT03903822|141330600|SUPERIORITY||LS Mean difference|-33.8|STANDARD_ERROR_OF_MEAN|9.27||0.0002|TWO_SIDED|90.0|-49.2|-18.4|||Mixed Model Repeated Measure|||At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-18.4|-49.2|0.0002
70920082|NCT03903822|141330600|SUPERIORITY||LS Mean difference|-0.9|STANDARD_ERROR_OF_MEAN|13.88||0.4739|TWO_SIDED|90.0|-23.9|22.0|||Mixed Model Repeated Measure|||At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||22.0|-23.9|0.4739
70920083|NCT03903822|141330600|SUPERIORITY||LS Mean difference|-19.1|STANDARD_ERROR_OF_MEAN|13.43||0.0789|TWO_SIDED|90.0|-41.3|3.2|||Mixed Model Repeated Measure|||At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||3.2|-41.3|0.0789
70920084|NCT03903822|141330600|SUPERIORITY||LS Mean difference|-13.4|STANDARD_ERROR_OF_MEAN|13.5||0.1611|TWO_SIDED|90.0|-35.7|8.9|||Mixed Model Repeated Measure|||At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||8.9|-35.7|0.1611
70920085|NCT03903822|141330600|SUPERIORITY||LS Mean Difference|-31.6|STANDARD_ERROR_OF_MEAN|13.94||0.0124|TWO_SIDED|90.0|-54.7|-8.5|||Mixed Model Repeated Measure|||At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-8.5|-54.7|0.0124
70920086|NCT03903822|141330600|SUPERIORITY||LS Mean difference|-5.3|STANDARD_ERROR_OF_MEAN|17.68||0.3828|TWO_SIDED|90.0|-34.7|24.1|||Mixed Model Repeated Measure|||At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||24.1|-34.7|0.3828
70920087|NCT03903822|141330600|SUPERIORITY||LS Mean difference|1.7|STANDARD_ERROR_OF_MEAN|17.8||0.5383|TWO_SIDED|90.0|-27.9|31.3|||Mixed Model Repeated Measure|||At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||31.3|-27.9|0.5383
70920088|NCT03903822|141330601|SUPERIORITY||Risk Difference (RD)|-5.4||||0.8964|TWO_SIDED|90.0|-16.1|2.0|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||2.0|-16.1|0.8964
70920089|NCT03903822|141330601|SUPERIORITY||Risk Difference (RD)|14.0||||0.0391|TWO_SIDED|90.0|1.0|28.2|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||28.2|1.0|0.0391
70920090|NCT03903822|141330601|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|90.0|-10.8|10.8|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||10.8|-10.8|1.0000
70920091|NCT03903822|141330601|SUPERIORITY||Risk Difference (RD)|11.3||||0.0708|TWO_SIDED|90.0|-1.4|25.0|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||25.0|-1.4|0.0708
70920092|NCT03903822|141330601|SUPERIORITY||Risk Difference (RD)|13.9||||0.0122|TWO_SIDED|90.0|4.7|27.0|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||27.0|4.7|0.0122
70920093|NCT03903822|141330601|SUPERIORITY||Risk Difference (RD)|21.6||||0.0016|TWO_SIDED|90.0|11.0|35.6|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||35.6|11.0|0.0016
70920094|NCT03903822|141330601|SUPERIORITY||Risk Difference (RD)|2.7||||0.395|TWO_SIDED|90.0|-9.8|16.1|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||16.1|-9.8|0.3950
70920095|NCT03903822|141330601|SUPERIORITY||Risk Difference (RD)|19.7||||0.0173|TWO_SIDED|90.0|4.2|35.6|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||35.6|4.2|0.0173
71032132|NCT01811953|141573008|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|96.13|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|91.25|101.26|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.|||101.26|91.25|<0.0001
70920096|NCT03903822|141330601|SUPERIORITY||Risk Difference (RD)|16.2||||0.0327|TWO_SIDED|90.0|1.4|31.0|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||31.0|1.4|0.0327
70920097|NCT03903822|141330601|SUPERIORITY||Risk Difference (RD)|30.8||||0.0011|TWO_SIDED|90.0|13.2|46.6|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||46.6|13.2|0.0011
70920098|NCT03903822|141330601|SUPERIORITY||Risk Difference (RD)|11.1||||0.1348|TWO_SIDED|90.0|-5.0|27.2|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||27.2|-5.0|0.1348
70920099|NCT03903822|141330601|SUPERIORITY||Risk Difference (RD)|18.5||||0.0328|TWO_SIDED|90.0|1.5|34.8|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||34.8|1.5|0.0328
70920100|NCT03903822|141330601|SUPERIORITY||Risk Difference (RD)|10.8||||0.0769|TWO_SIDED|90.0|-1.8|24.4|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||24.4|-1.8|0.0769
70920101|NCT03903822|141330601|SUPERIORITY||Risk Difference (RD)|30.7||||0.0005|TWO_SIDED|90.0|13.2|46.0|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||46.0|13.2|0.0005
70920102|NCT03903822|141330601|SUPERIORITY||Risk Difference (RD)|37.8|||<|0.0001|TWO_SIDED|90.0|22.1|53.1|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||53.1|22.1|<0.0001
70920103|NCT03903822|141330601|SUPERIORITY||Risk Difference (RD)|36.3||||0.0001|TWO_SIDED|90.0|19.7|51.8|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||51.8|19.7|0.0001
70920104|NCT03903822|141330601|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|90.0|-16.5|16.5|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||16.5|-16.5|1.0000
70920105|NCT03903822|141330601|SUPERIORITY||Risk Difference (RD)|23.8||||0.0173|TWO_SIDED|90.0|4.5|41.5|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||41.5|4.5|0.0173
70920106|NCT03903822|141330601|SUPERIORITY||Risk Difference (RD)|-2.7||||0.5663|TWO_SIDED|90.0|-19.9|14.2|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||14.2|-19.9|0.5663
70920107|NCT03903822|141330601|SUPERIORITY||Risk Difference (RD)|14.6||||0.1243|TWO_SIDED|90.0|-3.8|32.6|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||32.6|-3.8|0.1243
70920108|NCT03903822|141330601|SUPERIORITY||Risk Difference (RD)|18.9||||0.046|TWO_SIDED|90.0|-0.5|36.6|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||36.6|-0.5|0.0460
70920109|NCT03903822|141330601|SUPERIORITY||Risk Difference (RD)|25.7||||0.013|TWO_SIDED|90.0|4.8|43.3|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||43.3|4.8|0.0130
70920110|NCT03903822|141330601|SUPERIORITY||Risk Difference (RD)|13.9||||0.1194|TWO_SIDED|90.0|-4.2|31.4|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||31.4|-4.2|0.1194
70920111|NCT03903822|141330601|SUPERIORITY||Risk Difference (RD)|26.4||||0.0097|TWO_SIDED|90.0|6.5|44.4|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||44.4|6.5|0.0097
70920112|NCT03903822|141330601|SUPERIORITY||Risk Difference (RD)|-2.7||||0.5556|TWO_SIDED|90.0|-21.0|16.1|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||16.1|-21.0|0.5556
70920113|NCT03903822|141330601|SUPERIORITY||Risk Difference (RD)|17.6||||0.0761|TWO_SIDED|90.0|-2.5|36.5|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||36.5|-2.5|0.0761
70920114|NCT03903822|141330601|SUPERIORITY||Risk Difference (RD)|18.9||||0.0583|TWO_SIDED|90.0|-0.8|37.6|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||37.6|-0.8|0.0583
70920115|NCT03903822|141330601|SUPERIORITY||Risk Difference (RD)|14.9||||0.1245|TWO_SIDED|90.0|-5.0|33.7|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||33.7|-5.0|0.1245
70920116|NCT03903822|141330601|SUPERIORITY||Risk Difference (RD)|19.4||||0.0382|TWO_SIDED|90.0|1.5|36.5|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||36.5|1.5|0.0382
70920117|NCT03903822|141330601|SUPERIORITY||Risk Difference (RD)|34.7||||0.0011|TWO_SIDED|90.0|13.2|51.4|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||51.4|13.2|0.0011
70920118|NCT00895531|141330627|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||||||0.95
70920119|NCT02253537|141330645|EQUIVALENCE|2 x 2 contingency table with 95% CI.|2 x 2 contingency table|86.7|||||TWO_SIDED|95.0|62.1|96.3||||||||96.3|62.1|
70920120|NCT04470375|141330649|OTHER|Paired samples pre-post t-test||||||0.137|||||||t-test, 2 sided|||||||.137
70920121|NCT04470375|141330650|OTHER|Paired samples t-test (pre - post measure of group)||||||0.01|||||||t-test, 2 sided|||||||.010
70920122|NCT04470375|141330651|OTHER|Paired samples t-test (pre post measure of group)||||||0.591|||||||t-test, 2 sided|||||||.591
70920123|NCT03337399|141330657|NON_INFERIORITY|Non-inferiority of stepped PC was established if the lower one-sided 95% confidence limit for the estimated difference in means was greater than the pre-specified margin of -4.5 points, which corresponds to the one-sided 5% significance level test against this margin.|Mean Difference (Final Values)|2.9|||<|0.05|ONE_SIDED|95.0|-0.01||||Regression, Linear|||The difference in week 24 means between groups was estimated using a linear regression model adjusted for baseline FACT-L score.|||-.01|<0.05
70920124|NCT03337399|141330658|NON_INFERIORITY|Pre-specified margin of -10%.|Estimated Proportions|-2.6|||<|0.15|ONE_SIDED|95.0|-10.4|||We used a false discovery rate (FDR) control approach to interpret the results of significance tests of the three secondary outcomes with an FDR of 0.15.|Regression, Linear|||Non-inferiority of stepped PC in the proportion reporting patient-clinician communication about end-of-life care at each patient's final follow-up assessment was evaluated using a binomial generalized linear model with identity link and a one-sided test against the pre-specified margin of -10%.|||-10.4|<0.15
70972838|NCT03850912|141452356|SUPERIORITY||Odds Ratio (OR)|0.739|||<|0.001|TWO_SIDED|95.0|0.686|0.796|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (surgical patients only)||0.796|0.686|<0.001
70972839|NCT01358864|141452421|SUPERIORITY_OR_OTHER||Adjusted percent difference|52.8|||<|0.0001|TWO_SIDED|95.0|42.4|63.2||Adjusted for genotype and previous response to treatment|Cochran-Mantel-Haenszel|||||63.2|42.4|<0.0001
70972840|NCT01358864|141452421|SUPERIORITY_OR_OTHER||Adjusted percent difference|48.5|||<|0.0001|TWO_SIDED|95.0|38.2|58.9||Adjusted for genotype and previous response to treatment|Cochran-Mantel-Haenszel|||||58.9|38.2|<0.0001
70972841|NCT01358864|141452421|SUPERIORITY_OR_OTHER||Adjusted percent difference|4.4|||||TWO_SIDED|95.0|-6.0|14.9||||||||14.9|-6.0|
70972842|NCT01358864|141452421|SUPERIORITY_OR_OTHER||Adjusted percent difference|-0.1|||||TWO_SIDED|95.0|-10.9|10.7||||||||10.7|-10.9|
70972843|NCT01358864|141452421|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Normal approximation|||Comparison is based on the Null:Faldaprevir 12 weeks vs historical rate of 20%.||||<0.0001
70972844|NCT01358864|141452421|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Normal approximation|||Comparison is based on the Null:Faldaprevir 24 weeks vs historical rate of 20%.||||0.0001
70972845|NCT01358864|141452423|SUPERIORITY_OR_OTHER||Adjusted percent difference|54.7|||<|0.0001|TWO_SIDED|95.0|44.4|65.0||Adjusted for genotype and previous response to treatment|Cochran-Mantel-Haenszel|||||65.0|44.4|<0.0001
70972846|NCT01358864|141452423|SUPERIORITY_OR_OTHER||Adjusted percent difference|50.4|||<|0.0001|TWO_SIDED|95.0|40.1|60.8||Adjusted for genotype and previous response to treatment|Cochran-Mantel-Haenszel|||||60.8|40.1|<0.0001
70972847|NCT01358864|141452423|SUPERIORITY_OR_OTHER||Adjusted percent difference|4.5|||||TWO_SIDED|95.0|-5.8|14.9||||||||14.9|-5.8|
70972848|NCT01358864|141452423|SUPERIORITY_OR_OTHER||Adjusted percent difference|-0.1|||||TWO_SIDED|95.0|-10.9|10.7||||||||10.7|-10.9|
71032133|NCT01811953|141573008|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|99.34|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|TWO_SIDED|90.0|92.56|106.62|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.|||106.62|92.56|<0.0001
71032134|NCT01811953|141573008|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean difference|100.81|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|95.74|106.14|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.|||106.14|95.74|<0.0001
70972849|NCT01358864|141452423|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Normal approximation|||Comparison is based on the Null:Faldaprevir 12 weeks vs historical rate of 20%.||||<0.0001
70972850|NCT01358864|141452423|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Normal approximation|||Comparison is based on the Null:Faldaprevir 24 weeks vs historical rate of 20%.||||0.0001
70972851|NCT03194373|141452434|SUPERIORITY|Power to detect a 20% improvement in disease control rate (DCR). Based on historical data, the DCR in R/M HNSCC with single agent platinum therapy is 40%. We hypothesize that addition of Palbociclib will increase DCR at 12 weeks to 60%. Two-stage design. Type I error rate of 0.059 and power of 0.80 when the true response rate is 0.60 with alpha=0.05. The two-stage sample size calculations assume a null probability of 0.40.|Proportion|33.0|||||TWO_SIDED|95.0|13.0|59.0||||||||59|13|
70972852|NCT03194373|141452435|OTHER||||||||||||||||||Median survival times were computed using the Kaplan-Meier method with standard error computed using Greenwood's formula. All analyses were done using SAS 9.4 software.|||
70972853|NCT03194373|141452436|OTHER||||||||||||||||||Median survival times were computed using the Kaplan-Meier method with standard error computed using Greenwood's formula. All analyses were done using SAS 9.4 software.|||
70972854|NCT02177201|141452438|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis: The antiemetic effect was not significantly different for two groups in this study||||0.05
70972855|NCT02177201|141452438|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared, Corrected|||77 patients was needed in each groups for an 20% effect size, 5% alpha and 80% statistical power for postoperative vomiting.||||<0.05
70972856|NCT04209855|141452503|SUPERIORITY||Cox Proportional Hazard|0.63|||<|0.0001|TWO_SIDED|95.0|0.513|0.785|||Log Rank|||||0.785|0.513|<0.0001
70972857|NCT01250379|141452519|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0204|TWO_SIDED|95.0|0.65|0.97|||Log Rank||The 95% confidence interval (CI) was estimated using Cox proportional hazards methodology. The stratification factors used in the analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and lactate dehydrogenase (LDH) level.|||0.97|0.65|0.0204
70972858|NCT01250379|141452519|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.0245|TWO_SIDED|95.0|0.67|0.97|||Log Rank||Unstratified analysis.|||0.97|0.67|0.0245
70972859|NCT01250379|141452520|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59||||0.0088|TWO_SIDED|95.0|0.4|0.88|||Log Rank|||Subgroup analysis: HR-neg||0.88|0.40|0.0088
70972860|NCT01250379|141452520|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.1196|TWO_SIDED|95.0|0.67|1.05|||Log Rank|||Subgroup analysis: HR-pos/HER-neg||1.05|0.67|0.1196
70972861|NCT01250379|141452520|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.011|TWO_SIDED|95.0|0.43|0.9|||Log Rank|||Subgroup analysis: PFS \<6 months||0.90|0.43|0.0110
70972862|NCT01250379|141452520|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.0816|TWO_SIDED|95.0|0.65|1.03|||Log Rank|||Subgroup analysis: PFS ≥6 months||1.03|0.65|0.0816
70972863|NCT01250379|141452520|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55||||0.0395|TWO_SIDED|95.0|0.31|0.98|||Log Rank|||Subgroup analysis: taxane chemo||0.98|0.31|0.0395
70972864|NCT01250379|141452520|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.1385|TWO_SIDED|95.0|0.68|1.06|||Log Rank|||Subgroup analysis: non-taxane chemo||1.06|0.68|0.1385
70972865|NCT01250379|141452520|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41||||0.0029|TWO_SIDED|95.0|0.22|0.75|||Log Rank|||Subgroup analysis: vinorelbine chemo||0.75|0.22|0.0029
70972866|NCT01250379|141452520|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.0171|TWO_SIDED|95.0|0.62|0.96|||Log Rank|||Subgroup analysis: LDH ≤ 1.5 ULN||0.96|0.62|0.0171
70972867|NCT01250379|141452520|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.1797|TWO_SIDED|95.0|0.46|1.16|||Log Rank|||Subgroup analysis: LDH \> 1.5 ULN||1.16|0.46|0.1797
71094530|NCT02260986|141696807|SUPERIORITY||difference in percentages|26.1|||<|0.0001|TWO_SIDED|95.0|18.76|33.45||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 52 were considered as non-responders.||33.45|18.76|<0.0001
71094531|NCT02260986|141696808|SUPERIORITY||difference in percentages|40.1|||<|0.0001|TWO_SIDED|95.0|28.76|51.35||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 52 were considered as non-responders.||51.35|28.76|<0.0001
71094532|NCT02260986|141696808|SUPERIORITY||difference in percentages|27.3|||<|0.0001|TWO_SIDED|95.0|19.81|34.76||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 52 were considered as non-responders.||34.76|19.81|<0.0001
71094533|NCT02260986|141696809|SUPERIORITY||difference in percentages|37.9|||<|0.0001|TWO_SIDED|95.0|27.34|48.4||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 24 were considered as non-responders.||48.40|27.34|<0.0001
71032135|NCT01811953|141573009|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|102.33|STANDARD_ERROR_OF_MEAN|1.017|<|0.0001|TWO_SIDED|90.0|99.315|105.43|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.|||105.430|99.315|<0.0001
71094534|NCT02260986|141696809|SUPERIORITY||difference in percentages|27.7|||<|0.0001|TWO_SIDED|95.0|20.65|34.7||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 24 were considered as non-responders.||34.70|20.65|<0.0001
71032136|NCT01811953|141573009|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|98.82|STANDARD_ERROR_OF_MEAN|1.024|<|0.0001|TWO_SIDED|90.0|94.784|103.037|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.|||103.037|94.784|<0.0001
70972868|NCT01250379|141452520|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.0229|TWO_SIDED|95.0|0.62|0.97|||Log Rank|||Subgroup analysis: \< 65 years of age||0.97|0.62|0.0229
70972869|NCT01250379|141452520|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.2139|TWO_SIDED|95.0|0.51|1.16|||Log Rank|||Subgroup analysis: ≥ 65 years of age||1.16|0.51|0.2139
70972870|NCT01250379|141452520|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0021|TWO_SIDED|95.0|0.59|0.89|||Log Rank|||Subgroup analysis: \< 70 years of age||0.89|0.59|0.0021
70972871|NCT01250379|141452520|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||0.5216|TWO_SIDED|95.0|0.64|2.39|||Log Rank|||Subgroup analysis: ≥ 70 years of age||2.39|0.64|0.5216
70972872|NCT01250379|141452520|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.0148|TWO_SIDED|95.0|0.58|0.94|||Log Rank|||Subgroup analysis: \< 3 metastatic organ sites||0.94|0.58|0.0148
70972873|NCT01250379|141452520|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.3102|TWO_SIDED|95.0|0.61|1.17|||Log Rank|||Subgroup analysis: ≥ 3 metastatic organ sites||1.17|0.61|0.3102
70972874|NCT01250379|141452520|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.0967|TWO_SIDED|95.0|0.64|1.04|||Log Rank|||Subgroup analysis: B-free ≤ 6 weeks||1.04|0.64|0.0967
70972875|NCT01250379|141452520|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.0489|TWO_SIDED|95.0|0.51|1.0|||Log Rank|||Subgroup analysis: B-free \> 6 weeks||1.00|0.51|0.0489
70972876|NCT01250379|141452520|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.0176|TWO_SIDED|95.0|0.41|0.92|||Log Rank|||Subgroup analysis: D-free ≤ 24 months||0.92|0.41|0.0176
70972877|NCT01250379|141452520|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.2318|TWO_SIDED|95.0|0.66|1.11|||Log Rank|||Subgroup analysis: D-free \> 24 months||1.11|0.66|0.2318
70972878|NCT01250379|141452520|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.52||||0.0568|TWO_SIDED|95.0|0.26|1.03|||Log Rank|||Subgroup analysis: D-free ≤ 12 months||1.03|0.26|0.0568
70972879|NCT01250379|141452520|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.1143|TWO_SIDED|95.0|0.66|1.05|||Log Rank|||Subgroup analysis: D-free \> 12 months||1.05|0.66|0.1143
70972880|NCT01250379|141452521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1||||0.3457|TWO_SIDED|95.0|-4.2|12.4|||Chi-squared||The 95% CI was estimated using Hauck-Anderson methodology.|||12.4|-4.2|0.3457
71032137|NCT01811953|141573009|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|105.98|STANDARD_ERROR_OF_MEAN|1.018|<|0.0001|TWO_SIDED|90.0|102.73|109.329|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.|||109.329|102.730|<0.0001
71032138|NCT01811953|141573010|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|102.12|STANDARD_ERROR_OF_MEAN|1.035|<|0.0001|TWO_SIDED|90.0|96.255|108.351|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.|||108.351|96.255|<0.0001
71032139|NCT01811953|141573010|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|106.52|STANDARD_ERROR_OF_MEAN|1.063||0.0082|TWO_SIDED|90.0|95.863|118.353|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.|||118.353|95.863|0.0082
71094535|NCT02260986|141696810|SUPERIORITY||difference in percentages|20.9|||<|0.0001|TWO_SIDED|95.0|10.59|31.15||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 4 were considered as non-responders.||31.15|10.59|<0.0001
70920125|NCT03337399|141330659|NON_INFERIORITY|Pre-specified margin of -7 days|Median Difference (Final Values)|-15.2||||0.15|ONE_SIDED|95.0|-25.1|||We used a false discovery rate (FDR) control approach to interpret the results of significance tests of the three secondary outcomes with an FDR of 0.15.|Regression, Linear|||Among patients who died, non-inferiority of stepped PC in the mean length of stay in hospice was assessed using linear regression and a one-sided test against the pre-specified margin of -7 days, based upon published quality metrics.|||-25.1|0.15
70920126|NCT03337399|141330660|SUPERIORITY||Median Difference (Final Values)|-2.3||||0.15|TWO_SIDED|95.0|-2.7|-1.8||We used a false discovery rate (FDR) control approach to interpret the results of significance tests of the three secondary outcomes with an FDR of 0.15|Regression, Linear|||The difference between groups in the mean number of outpatient PC visits per patient by week 24 was assessed using linear regression and a two-sided superiority test.||-1.8|-2.7|0.15
70920127|NCT02708108|141330665|OTHER|Multivariable analysis|Odds Ratio (OR)|0.3||||0.02|TWO_SIDED|95.0|0.09|0.92||Reported as 1-sided p-value.|Regression, Logistic||Multivariable model includes age, BMI category, cytogenetic risk, ethnicity, sex|||0.92|0.09|0.02
70920128|NCT02214550|141330684|SUPERIORITY||Slope|-1.96|STANDARD_ERROR_OF_MEAN|0.69||0.02|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter reported indicates time x group interaction (OCP vs. No OCP). PBS participants are included in the OCP group|A linear mixed-effects model was estimated predicting bladder pain at first urge ratings (0-100 visual analog scale) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The following three orthogonal contrasts were estimated: 1) OCP vs. No OCP, 2) cyclic vs. continuous microgestin, and 3) PBS-continuous microgestin vs. D+COS-continuous microgestin.||||.02
70920129|NCT02214550|141330684|SUPERIORITY||Slope|-1.4597|STANDARD_ERROR_OF_MEAN|0.8245||0.08|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter estimated indicates the time x group (Continuous vs. Cyclic OCP) interaction. PBS participants are included in the continuous OCP group.|A linear mixed-effects model was estimated predicting bladder pain at first urge ratings (0-100 visual analog scale) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The following three orthogonal contrasts were estimated: 1) OCP vs. No OCP, 2) cyclic vs. continuous microgestin, and 3) PBS-continuous microgestin vs. D+COS-continuous microgestin.||||.08
70920130|NCT02214550|141330684|SUPERIORITY||Slope|1.9186|STANDARD_ERROR_OF_MEAN|0.8121||0.023|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter reported indicates a time x group interaction (D+COS-continuous microgestin vs. PBS-continuous microgestin).|A linear mixed-effects model was estimated predicting bladder pain at first urge ratings (0-100 visual analog scale) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The following three orthogonal contrasts were estimated: 1) OCP vs. No OCP, 2) cyclic vs. continuous microgestin, and 3) PBS-continuous microgestin vs. D+COS-continuous microgestin.||||.023
70920131|NCT02214550|141330685|SUPERIORITY||Slope|0.3716|STANDARD_ERROR_OF_MEAN|0.3056||0.2315|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter reported indicates time\*group interaction (OCP vs. No OCP). PBS participants are included in the OCP group|A linear mixed-effects model was estimated predicting pressure pain thresholds (in Newtons of force transvaginally measured anteriorly against the bladder) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The following three orthogonal contrasts were estimated: 1) OCP vs. No OCP, 2) cyclic vs. continuous microgestin, and 3) PBS-continuous microgestin vs. D+COS-continuous microgestin.||||0.2315
70972881|NCT01250379|141452523|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9825|TWO_SIDED|95.0|0.51|1.99|||Log Rank||The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.|||1.99|0.51|0.9825
70972882|NCT01250379|141452523|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||0.3601|TWO_SIDED|95.0|0.73|2.34|||Log Rank||Unstratified analysis.|||2.34|0.73|0.3601
70972883|NCT01250379|141452526|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.108|TWO_SIDED|95.0|0.59|1.06|||Log Rank||The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.|||1.06|0.59|0.1080
70972884|NCT01250379|141452526|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0625|TWO_SIDED|95.0|0.59|1.02|||Log Rank||Unstratified analysis.|||1.02|0.59|0.0625
70972885|NCT01250379|141452528|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.1349|TWO_SIDED|95.0|0.68|1.05|||Log Rank||The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.|||1.05|0.68|0.1349
70972886|NCT01250379|141452528|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0863|TWO_SIDED|95.0|0.68|1.03|||Log Rank||Unstratified analysis.|||1.03|0.68|0.0863
70972887|NCT01250379|141452530|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.0744|TWO_SIDED|95.0|0.65|1.02|||Log Rank||The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.|||1.02|0.65|0.0744
70972888|NCT01250379|141452530|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.0503|TWO_SIDED|95.0|0.66|1.0|||Log Rank||Unstratified analysis.|||1.00|0.66|0.0503
70972889|NCT01250379|141452533|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.7253|TWO_SIDED|95.0|0.76|1.21|||Log Rank||The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.|||1.21|0.76|0.7253
70972890|NCT01250379|141452533|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.5332|TWO_SIDED|95.0|0.75|1.16|||Log Rank||Unstratified analysis.|||1.16|0.75|0.5332
70972891|NCT01327157|141452585|EQUIVALENCE|The comparison among the groups, from the results obtained by the Visual Analog Scale (VAS), was done through analysis of variance models (ANOVA) with two factors.|Mean Difference (Net)|0.5||||0.524|TWO_SIDED|||||Statistical significance was considered for values of p \<0.05 and it was used The Minitab statistical software, version 15.1 to obtain the results.|t-test, 1 sided|The comparison between the groups in each study period (initial) was done through the t-test for two independent samples.||"We assessed the quality of oral functions in the first query to check the status of discomfort before treatment in both groups, using VAS..~Statistical significance was considered for values of p \<0.05 and it was used The Minitab statistical software, version 15.1 to obtain the results"||||0.524
70972892|NCT01327157|141452586|EQUIVALENCE|"Only the treatment group was analysed. The dental contacts were evaluated in models and gnathostats demarcated after the points were counted in the models before and after treatment If an increase in the number of dental contacts after occlusal adjustment was detected, in relation of the models.~The models are made in the first and last query, after four visits with one month interval between them."|Mean Difference (Net)|5.0|STANDARD_DEVIATION|3.92|<|0.001|TWO_SIDED||||||t-test, 2 sided|||The brand carbon mark was done on the treatment group in the first and last query.||||<0.001
71032140|NCT01811953|141573010|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|104.352|STANDARD_ERROR_OF_MEAN|1.031|<|0.0001|TWO_SIDED|90.0|99.152|110.224|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.|||110.224|99.152|<0.0001
70972893|NCT01327157|141452587|EQUIVALENCE|The comparison among the groups, from the results obtained by the Visual Analog Scale (VAS), was done through analysis of variance models (ANOVA) with two factors. The comparison among the groups, in each period of the study (initial and final) was done through t test for two independent samples.|Mean Difference (Net)|2.4|STANDARD_DEVIATION|1.44||0.002|TWO_SIDED||||||t-test, 2 sided|||"We assessed the quality of oral functions in the last query to check the status of discomfort after ninety days in both groups, control and treatment, using VAS.~The statistical significance was considered to p\<0.05 values and it was used the Minitab statistics software, 15.1 version, to get the results."||||0.002
70972894|NCT01327157|141452588|OTHER|||||||0.705|||||||t-test, 1 sided|||||||0.705
70972895|NCT01327157|141452589|OTHER|||||||0.01|||||||t-test, 1 sided|||||||0.01
70972896|NCT04647253|141452612|SUPERIORITY||Rate difference between treatment groups|-10.8||||0.0025|TWO_SIDED|95.0|-18.4|-3.3||a priori threshold for statistical significance was 0.025|z-test with unpooled variance|||||-3.3|-18.4|0.0025
70972897|NCT03118297|141452716|SUPERIORITY|||||||0.002||||||Threshold for significance: p=0.05|Wilcoxon (Mann-Whitney)|||||||0.002
70972898|NCT03118297|141452717|SUPERIORITY|||||||0.032||||||Threshold for significance: p=0.05|Fisher Exact|||||||0.032
70972899|NCT03118297|141452718|SUPERIORITY||||||<|0.001||||||Threshold for significance: p=0.05|Fisher Exact|||||||<0.001
70972900|NCT03118297|141452719|SUPERIORITY||||||>|0.05||||||Threshold for significance: p=0.05|Chi-squared|||||||>0.05
70972901|NCT03118297|141452720|OTHER|No statistical test performed|||||||||||||||||Significance testing not performed. All values below prespecified limit of 5.0 ng/mL.|||
70972902|NCT02479802|141452721|OTHER||||||<|0.0001|||||||t-test, 1 sided|||Change from Baseline at Week 48.||||<0.0001
70972903|NCT02479802|141452722|OTHER|||||||0.0006|||||||t-test, 1 sided|||Change from Baseline at Week 48.||||0.0006
70972904|NCT01202656|141452781|SUPERIORITY_OR_OTHER|||||||0.72|||||||Cochran-Mantel-Haenszel|||||||0.72
71008730|NCT02055976|141525247|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-12.911|STANDARD_ERROR_OF_MEAN|10.309||0.107|TWO_SIDED|95.0|-33.411|7.589|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.589|-33.411|0.107
70920132|NCT02214550|141330685|SUPERIORITY||Slope|0.2703|STANDARD_ERROR_OF_MEAN|0.3244||0.4097|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter estimated indicates the time x group (Continuous vs. Cyclic OCP) interaction. PBS participants are included in the continuous OCP group.|A linear mixed-effects model was estimated predicting pressure pain thresholds (in Newtons of force transvaginally measured anteriorly against the bladder) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The following three orthogonal contrasts were estimated: 1) OCP vs. No OCP, 2) cyclic vs. continuous microgestin, and 3) PBS-continuous microgestin vs. D+COS-continuous microgestin.||||0.4097
71032141|NCT01811953|141573011|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|94.87|STANDARD_ERROR_OF_MEAN|1.038||0.0001|TWO_SIDED|90.0|88.931|101.21|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.|||101.210|88.931|0.0001
71032142|NCT01811953|141573011|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|97.97|STANDARD_ERROR_OF_MEAN|1.035|<|0.0001|TWO_SIDED|90.0|92.339|103.935|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.|||103.935|92.339|<0.0001
71032143|NCT01811953|141573011|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|102.95|STANDARD_ERROR_OF_MEAN|1.034|<|0.0001|TWO_SIDED|90.0|97.166|109.082|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.|||109.082|97.166|<0.0001
71032144|NCT01811953|141573012|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|94.89|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|89.8|100.26|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.|||100.26|89.80|<0.0001
70920133|NCT02214550|141330685|SUPERIORITY||Slope|-0.1574|STANDARD_ERROR_OF_MEAN|0.3283||0.6341|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter estimated indicates the time x group (continuous microgestin: D+COS-vs. PBS) interaction.|A linear mixed-effects model was estimated predicting pressure pain thresholds (in Newtons of force transvaginally measured anteriorly against the bladder) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The following three orthogonal contrasts were estimated: 1) OCP vs. No OCP, 2) cyclic vs. continuous microgestin, and 3) PBS-continuous microgestin vs. D+COS-continuous microgestin.||||0.6341
70920134|NCT02214550|141330686|SUPERIORITY||Slope|0.086|STANDARD_ERROR_OF_MEAN|0.1||0.393|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter reported indicates time x group interaction (OCP vs. No OCP). PBS participants are included in the OCP group.|A linear mixed-effects model was estimated for parieto-occipital peak alpha (Hz) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The OCP vs No OCP contrast was estimated here:||||.393
70920135|NCT02214550|141330686|SUPERIORITY||Slope|0.007|STANDARD_ERROR_OF_MEAN|0.09||0.941|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameters reported indicates time x group (Continuous vs. Cyclic OCP) interaction. PBS participants are included in the continuous OCP group.|A linear mixed-effects model was estimated for parieto-occipital peak alpha (Hz) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The cyclic vs. continuous microgestin contrast was run here||||0.941
70920136|NCT02214550|141330686|SUPERIORITY||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.1||0.005|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter reported indicates time x group interaction (D+COS-continuous microgestin vs. PBS-continuous microgestin).|A linear mixed-effects model was estimated for parieto-occipital peak alpha (Hz) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The PBS-continuous microgestin vs. D+COS-continuous microgestin contrast was evaluated here||||0.005
70920137|NCT05113771|141330729|SUPERIORITY||LS Mean Difference|-4.4||||0.0056|TWO_SIDED|95.0|-7.6|-1.3|||MMRM|mixed model for repeated measures (MMRM) with imputation based on the missing at random (MAR) assumption was used.||||-1.3|-7.6|0.0056
70920138|NCT05113771|141330730|SUPERIORITY|||||||0.0189|||||||MMRM|||||||0.0189
70920139|NCT05113771|141330731|SUPERIORITY|||||||0.0026|||||||Cochran-Mantel-Haenszel|||||||0.0026
70920140|NCT00390299|141330741|OTHER||Maximum Tolerated Dose (x 10^7 TCID50)|1.0|||||TWO_SIDED|||||||||||||
70920141|NCT00390299|141330741|OTHER||Maximum Tolerated Dose (x 10^7 TCID50)|1.0|||||TWO_SIDED|||||||||||||
70920142|NCT00390299|141330745|SUPERIORITY||Hazard Ratio (HR)|1.66||||0.28|TWO_SIDED|95.0|0.67|4.11|||Log Rank|||||4.11|0.67|0.28
70920143|NCT01061671|141330776|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||negative binomial regression|Adjustments of confidence intervals for between-participant variation (overdispersion).||||||0.54
70920144|NCT01061671|141330777|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Log Rank|||||||0.34
70920145|NCT01061671|141330778|SUPERIORITY_OR_OTHER|||||||0.1461|TWO_SIDED||||||t-test, 2 sided|||||||.1461
71032145|NCT01811953|141573012|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|99.31|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|TWO_SIDED|90.0|92.14|107.03|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.|||107.03|92.14|<0.0001
71032146|NCT01811953|141573012|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|100.74|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|95.77|105.96|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.|||105.96|95.77|<0.0001
71032147|NCT01049334|141573014|SUPERIORITY_OR_OTHER||least-square means difference|-151.5||||0.0201|TWO_SIDED|95.0|-278.9|-24.0||The a priori threshold for statistical significance is 0.05. No adjustments for statistical multiplicity were required.|ANOVA|Treatment as a fixed effect and baseline STPIS as a covariate.||||-24.0|-278.9|0.0201
70920146|NCT00475501|141330799|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.9|STANDARD_DEVIATION|2.57|<|0.001|TWO_SIDED|95.0|7.86|18.0||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis||mean difference is for subjects reveiving testosterone (groups T and T/F) vs. subjects not receiving testosterone (F and Placebo)|The studies was powered for 1-RM strength based on a 1.18-alpha increase reported in the literature||18.0|7.86|<0.001
70920147|NCT00475501|141330800|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77|STANDARD_DEVIATION|0.311||0.015|TWO_SIDED|95.0|0.16|1.31||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered on grip strength. We employed 2x2 analysis to determine effects of testosterone, finasteride and interaction.||1.31|0.16|0.015
70920148|NCT00475501|141330801|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.19|STANDARD_DEVIATION|1.142|<|0.001|TWO_SIDED|95.0|1.95|6.43||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered on lumbar spine bone mineral density. We employed a 2x2 analysis for effects ot testosterone, finasteride and interaction||6.43|1.95|<0.001
70920149|NCT00475501|141330802|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.737|STANDARD_ERROR_OF_MEAN|0.343||0.037|TWO_SIDED|95.0|-1.41|-0.064||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study is was not powered for score on Geriatric Depression Scale||-0.064|-1.41|0.037
70920150|NCT00475501|141330803|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.871|STANDARD_ERROR_OF_MEAN|1.108||0.012|TWO_SIDED|95.0|0.699|5.04||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered for 30-minute recall on Rey figure test||5.04|0.699|0.012
70920151|NCT00475501|141330804|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.642|STANDARD_ERROR_OF_MEAN|2.272||0.779|TWO_SIDED|95.0|-5.095|3.811||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered for score on Trials A test||3.811|-5.095|0.779
71032148|NCT01049334|141573015|SUPERIORITY_OR_OTHER||least-square means difference|-19.6|||<|0.0001|TWO_SIDED|95.0|-29.2|-9.9||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|ANOVA|Treatment as a fixed effect and baseline of the variable predicted as a covariate||||-9.9|-29.2|<.0001
70920152|NCT00475501|141330805|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.587|STANDARD_ERROR_OF_MEAN|0.743||0.433|TWO_SIDED|95.0|-0.869|2.043||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered for score on Benton test||2.043|-0.869|0.433
70920153|NCT00475501|141330806|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.13|STANDARD_DEVIATION|0.54|<|0.001|TWO_SIDED|95.0|3.07|5.18||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||This study was powered for hematocrit based on literature report that testosterone \> 2 alpha increase in hematocrit||5.18|3.07|<0.001
70920154|NCT00475501|141330807|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1419|STANDARD_ERROR_OF_MEAN|0.2529||0.6219|TWO_SIDED|95.0|-0.353|6.37||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered for dietary protein intake||6.37|-0.353|0.6219
70920155|NCT00475501|141330808|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.33|STANDARD_DEVIATION|1.83||0.0051|TWO_SIDED|95.0|1.73|8.94||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was powered for prostate volume based on a literature report that testosterone increases prostate volume 1.85 alpha per year. We employed a 2x2 analysis for effects of testosterone, finasteride and interaction.||8.94|1.73|0.0051
70972905|NCT01562548|141452784|SUPERIORITY_OR_OTHER||Least Squares Means Difference|-0.21||||0.68|TWO_SIDED|95.0|-1.23|0.8||P-value was associated with t-test for difference of LS means|t-test, 2 sided|The model included factors for treatment (as a fixed effect) and site (as a random effect).|Least Square mean from Mixed Model including factors for treatment (as a fixed effect) and site (as a random effect). Difference was First named treatment - second named treatment|Null hypotheses was tested as: H01: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 600mg and placebo. H02: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and placebo. H03: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and Guaifenesin 600mg.||0.80|-1.23|0.68
70972906|NCT01562548|141452784|SUPERIORITY_OR_OTHER||Least Squares Means Difference|0.35||||0.52|TWO_SIDED|95.0|-0.72|1.42||P-value associated with t-test for difference of LS means|t-test, 2 sided||Least Square mean from Mixed Model including factors for treatment (as a fixed effect) and site (as a random effect). Difference was First named treatment - second named treatment|Null hypotheses was tested as: H01: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 600mg and placebo. H02: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and placebo. H03: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and Guaifenesin 600mg.||1.42|-0.72|0.52
70972907|NCT01562548|141452784|SUPERIORITY_OR_OTHER||Least Squares Means Difference|0.24||||0.58|TWO_SIDED|95.0|-0.64|1.13||P-value associated with t-test for difference of LS means|t-test, 2 sided||Least Square mean from Mixed Model including factors for treatment (as a fixed effect) and site (as a random effect). Difference was Second named treatment - first named treatment|Null hypotheses was tested as: H01: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 600mg and placebo. H02: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and placebo. H03: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and Guaifenesin 600mg.||1.13|-0.64|0.58
70972908|NCT01496066|141452798|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<.0001
70972909|NCT01496066|141452799|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<.0001
70972910|NCT01496066|141452800|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<.0001
71094536|NCT02260986|141696810|SUPERIORITY||difference in percentages|10.7||||0.0021|TWO_SIDED|95.0|4.15|17.31||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 4 were considered as non-responders.||17.31|4.15|0.0021
70972911|NCT01496066|141452801|SUPERIORITY|||||||0.0318|||||||t-test, 2 sided|||||||.0318
70972912|NCT01496066|141452802|EQUIVALENCE|a two-group t-test of equivalence in means was used|Mean Difference (Final Values)|-0.04|||||TWO_SIDED|99.0|-0.06|-0.02||||||||-0.02|-0.06|
70972913|NCT03138876|141452818|SUPERIORITY|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||||||0.0005
70972914|NCT03987854|141452822|SUPERIORITY||paired t-test|-7.67|STANDARD_DEVIATION|6.1|<|0.001|TWO_SIDED|||||-6.16|t-test, 2 sided|||||||<.001
70972915|NCT03987854|141452823|SUPERIORITY||paired t-test|-0.21|STANDARD_DEVIATION|0.27||0.001|TWO_SIDED|||||-3.29|t-test, 2 sided|||||||.001
71032149|NCT01049334|141573016|SUPERIORITY_OR_OTHER||least-square means difference|-22.3|||<|0.0001|TWO_SIDED|95.0|-31.7|-12.9||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|ANOVA|Treatment as a fixed effect and baseline of the variable predicted as a covariate||||-12.9|-31.7|<0.0001
70972916|NCT03987854|141452824|SUPERIORITY||paired t-test|1.92|STANDARD_DEVIATION|1.17|<|0.001|TWO_SIDED|||||7.52|t-test, 2 sided|||||||<.001
70972917|NCT03987854|141452825|SUPERIORITY||paired t-test|1.14|STANDARD_DEVIATION|1.04|<|0.001|TWO_SIDED|||||5.03|t-test, 2 sided|||||||<.001
70972918|NCT03987854|141452826|SUPERIORITY||paired t-test|2.52|STANDARD_DEVIATION|1.7|<|0.001|TWO_SIDED|||||6.81|t-test, 2 sided|||||||<.001
70972919|NCT03987854|141452827|SUPERIORITY||paired t-test|1.08|STANDARD_DEVIATION|1.43||0.003|TWO_SIDED|||||3.46|t-test, 2 sided|||||||.003
70972920|NCT03987854|141452828|SUPERIORITY||paired t-test|1.11|STANDARD_DEVIATION|1.56||0.004|TWO_SIDED|||||3.26|t-test, 2 sided|||||||.004
70972921|NCT03987854|141452829|SUPERIORITY||paired t-test|2.1|STANDARD_DEVIATION|2.76||0.002|TWO_SIDED|||||3.49|t-test, 2 sided|||||||.002
70972922|NCT01844895|141452837|SUPERIORITY_OR_OTHER||geometric mean ratio|0.91|||||TWO_SIDED|90.0|0.83|1.0||||||A mixed-effect model of log (Cminss) with device and substudy baseline weight category (\< 60 kg,60-100 kg, \> 100 kg) as fixed effects and participant as a random effect was used. Point estimates and 90% CIs for device differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale. No adjustment was made for multiplicity. PK comparability was concluded if the 90% CIs for the ratios of geometric means were contained within 80% to 125%.||1.00|0.83|
70972923|NCT06245551|141452848|OTHER|The analysis is applied to the All-subjects data.|Mean Difference (Final Values)|-17.52|||<|0.001|TWO_SIDED|95.0|-19.78|-15.25|||Mixed Models Analysis|||||-15.25|-19.78|<0.001
70972924|NCT02508194|141452854|SUPERIORITY||Vaccine efficacy|-7.1|||||TWO_SIDED|90.0|-106.9|44.3|||||The CI was estimated by an exact conditional method.|2 sided 90 percent (%) confidence interval (CI) was used to compare vaccine efficacy (VE). VE = (\[1 - relative risk (RR)\] \*100%), where RR was the RR of ARA-RI in the MEDI7510 group compared with the placebo group. A lower bound of the 90% CI greater than (\>) 0% would demonstrate the efficacy of MEDI7510.||44.3|-106.9|
70972925|NCT00511355|141452875|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0849||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0849
70972926|NCT00511355|141452877|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
70972927|NCT00511355|141452878|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4191||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.4191
70972928|NCT00511355|141452879|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0010
70972929|NCT00511355|141452883|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3779||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.3779
70972930|NCT00511355|141452884|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5027||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.5027
70972931|NCT00511355|141452885|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0041||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0041
70972932|NCT00511355|141452886|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9662||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.9662
70972933|NCT00511355|141452887|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0004
70972934|NCT00511355|141452888|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0019
71032150|NCT01049334|141573017|SUPERIORITY_OR_OTHER||least-square means difference|-181.7||||0.0071|TWO_SIDED|95.0|-313.7|-50.0||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|ANOVA|Treatment as a fixed effect and baseline of the variable predicted as a covariate||||-50.0|-313.7|0.0071
71032151|NCT01049334|141573018|SUPERIORITY_OR_OTHER||least-square means difference|-20.8|||<|0.0001|TWO_SIDED|95.0|-30.2|-11.2||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|ANOVA|Treatment as a fixed effect and baseline of the variable predicted as a covariate||||-11.2|-30.2|<0.0001
71032152|NCT01049334|141573019|SUPERIORITY_OR_OTHER||least-square means difference|-137.6||||0.0393|TWO_SIDED|95.0|-268.5|-6.8||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|ANOVA|Treatment as a fixed effect and baseline of the variable predicted as a covariate||||-6.8|-268.5|0.0393
71032153|NCT01049334|141573020|SUPERIORITY_OR_OTHER|||||||0.0459||||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|Wilcoxon (Mann-Whitney)|||||||0.0459
71032154|NCT01049334|141573021|SUPERIORITY_OR_OTHER|||||||0.8383||||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|Wilcoxon (Mann-Whitney)|||||||0.8383
71032155|NCT01049334|141573022|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|95.0||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|Wilcoxon (Mann-Whitney)|||||||0.0005
70972935|NCT00511355|141452889|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9662||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.9662
70972936|NCT00511355|141452890|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0187||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0187
70972937|NCT00511355|141452891|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
70972938|NCT00511355|141452892|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6886||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.6886
70972939|NCT00511355|141452893|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
70972940|NCT00511355|141452894|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
70972941|NCT00511355|141452895|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0083||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0083
70972942|NCT00511355|141452896|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0455||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0455
70972943|NCT00511355|141452897|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0063||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0063
70972944|NCT00511355|141452898|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
70972945|NCT00511355|141452899|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
70972946|NCT00511355|141452900|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0078||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0078
70972947|NCT00511355|141452901|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0016||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0016
70972948|NCT00511355|141452902|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0003
70972949|NCT00511355|141452903|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0009
70972950|NCT00511355|141452904|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0024||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0024
70972951|NCT00511355|141452905|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3653||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.3653
70972952|NCT00511355|141452906|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
71032156|NCT01049334|141573023|SUPERIORITY_OR_OTHER|||||||0.0005||||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|Wilcoxon (Mann-Whitney)|||||||0.0005
70972953|NCT00511355|141452907|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
70972954|NCT00511355|141452908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5668||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.5668
70972955|NCT00511355|141452909|SUPERIORITY_OR_OTHER_LEGACY|||||||0.177||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.1770
70972956|NCT00511355|141452910|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
70972957|NCT03742037|141452929|SUPERIORITY||LS mean difference to placebo|-0.39|STANDARD_ERROR_OF_MEAN|0.54||0.4749|TWO_SIDED|95.0|-1.45|0.68|||Mixed Models Analysis|||The analysis was performed on the Full Analysis Set (FAS). The FAS included all participants who were randomized. Baseline was defined as the last measurement before randomization.||0.68|-1.45|0.4749
70972958|NCT03742037|141452929|SUPERIORITY||LS mean to placebo|-0.57|STANDARD_ERROR_OF_MEAN|0.54||0.2941|TWO_SIDED|95.0|-1.65|0.49|||Mixed Models Analysis|||The analysis was performed on the Full Analysis Set (FAS). The FAS included all participants who were randomized. Baseline was defined as the last measurement before randomization.||0.49|-1.65|0.2941
70972959|NCT03742037|141452929|SUPERIORITY||LS mean difference to placebo|0.01|STANDARD_ERROR_OF_MEAN|0.54||0.9802|TWO_SIDED|95.0|-1.05|1.08|||Mixed Models Analysis|||The analysis was performed on the Full Analysis Set (FAS). The FAS included all participants who were randomized. Baseline was defined as the last measurement before randomization.||1.08|-1.05|0.9802
70972960|NCT03742037|141452929|SUPERIORITY||LS mean difference|-1.19|STANDARD_ERROR_OF_MEAN|0.54||0.0291|TWO_SIDED|95.0|-2.25|-0.12|||Mixed Models Analysis|||The analysis was performed on the Full Analysis Set (FAS). The FAS included all participants who were randomized. Baseline was defined as the last measurement before randomization.||-0.12|-2.25|0.0291
70920156|NCT00475501|141330809|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.868|STANDARD_ERROR_OF_MEAN|0.668||0.196|TWO_SIDED|95.0|-3.434|1.698||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered for score on Lif Satisfaction A test||1.698|-3.434|0.196
70920157|NCT01803555|141330823|NON_INFERIORITY|The noninferiority of BF Spiromax to Symbicort Turbohaler was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) for the treatment difference was greater than -15 L/min.|Least Square (LS) mean difference|-2.957||||0.3387|TWO_SIDED|95.0|-9.02|3.11|||Mixed Models Analysis|Analysis included effects due to baseline weekly average of daily trough AM PEF, gender, age, treatment, time, and treatment-by-time interaction.||||3.11|-9.02|0.3387
70920158|NCT05165485|141330830|SUPERIORITY||Mean Difference (Net)|-23.0||||0.22|TWO_SIDED|95.0|-61.0|14.0||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence, stopping after the first failure to reject the null hypothesis.|Mixed Models Analysis|Denominator degrees of freedom were approximated by the Kenward and Roger (1997) method.|Revefenacin - Tiotropium Least Squares Mean Difference|The null hypothesis was that the Revefenacin - Tiotropium Least Squares Mean Difference was zero and the alternative hypothesis was that it was nonzero.|The Revefenacin - Tiotropium Least Squares Mean Difference was estimated by fitting a repeated measures mixed model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FEV1, screening FEV1, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|14|-61|0.22
70972961|NCT03742037|141452930|SUPERIORITY||Odds Ratio (OR)|1.01||||0.974|TWO_SIDED|95.0|0.54|1.9|||Mixed Models Analysis|||A generalized mixed effects model for repeated measures was applied to the SRI-4 response from Month 1 through 6 with treatment group, month, treatment group by month interaction, and stratification factors (oral corticosteroids dose \& mSLEDAI-2K) as fixed effects \& participant as random effect.||1.9|0.54|0.974
70972962|NCT03742037|141452930|SUPERIORITY||Odds Ratio (OR)|1.42||||0.2845|TWO_SIDED|95.0|0.75|2.65|||Mixed Models Analysis|||A generalized mixed effects model for repeated measures was applied to the SRI-4 response from Month 1 through 6 with treatment group, month, treatment group by month interaction, and stratification factors (oral corticosteroids dose \& mSLEDAI-2K) as fixed effects \& participant as random effect.||2.65|0.75|0.2845
70972963|NCT03742037|141452930|SUPERIORITY||Odds Ratio (OR)|1.23||||0.5115|TWO_SIDED|95.0|0.66|2.32|||Mixed Models Analysis|||A generalized mixed effects model for repeated measures was applied to the SRI-4 response from Month 1 through 6 with treatment group, month, treatment group by month interaction, and stratification factors (oral corticosteroids dose \& mSLEDAI-2K) as fixed effects \& participant as random effect.||2.32|0.66|0.5115
70972964|NCT03742037|141452930|SUPERIORITY||Odds Ratio (OR)|1.23||||0.5115|TWO_SIDED|95.0|0.66|2.32|||Mixed Models Analysis|||A generalized mixed effects model for repeated measures was applied to the SRI-4 response from Month 1 through 6 with treatment group, month, treatment group by month interaction, and stratification factors (oral corticosteroids dose \& mSLEDAI-2K) as fixed effects \& participant as random effect.||2.32|0.66|0.5115
70972965|NCT00802685|141452932|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.0|STANDARD_DEVIATION|8.0||0.858|TWO_SIDED|95.0|4.0|36.0|||Wilcoxon (Mann-Whitney)|||Null hypothesis: Oxygen duration (days) during the first 28 days will be equal between treatment arms.||36|4|0.858
70972966|NCT00802685|141452933|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.953||||0.8|TWO_SIDED|95.0|0.393|2.309|||Cochran-Mantel-Haenszel|||null hypothesis: The proportion of subjects on O2 at 36 wk PMA will be equal between treatment arms.||2.309|0.393|0.8
70972967|NCT03208231|141452939|SUPERIORITY|||||||0.79|||||||Fisher Exact|||||||0.79
70972968|NCT03208231|141452940|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
70972969|NCT02321436|141452970|OTHER|The treatment difference (Dysport® versus placebo) was tested using a non-parametric, two-sided, stratified log rank test.||||||0.0176||||||Significance level (α) = 5%|Log Rank|||||||0.0176
70972970|NCT02321436|141452970|OTHER|The treatment difference (Dysport® versus placebo) was tested using a non-parametric, two-sided, stratified Wilcoxon test.||||||0.048||||||Significance level (α) = 5%|Wilcoxon (Mann-Whitney)|||||||0.0480
70972971|NCT02321436|141452971|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-1.0||||0.0005|TWO_SIDED|95.0|-1.54|-0.47||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 2 (Week 4).||-0.47|-1.54|0.0005
70972972|NCT02321436|141452971|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-1.05||||0.0007|TWO_SIDED|95.0|-1.63|-0.47||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 3 (Week 6).||-0.47|-1.63|0.0007
70972973|NCT02321436|141452971|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-1.05||||0.0006|TWO_SIDED|95.0|-1.62|-0.48||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 4 (Week 8).||-0.48|-1.62|0.0006
70972974|NCT02321436|141452971|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.84||||0.0027|TWO_SIDED|95.0|-1.36|-0.31||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 5 (Week 10).||-0.31|-1.36|0.0027
71032157|NCT01049334|141573024|SUPERIORITY_OR_OTHER|||||||0.0002||||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|Wilcoxon (Mann-Whitney)|||||||0.0002
71032158|NCT01049334|141573025|SUPERIORITY_OR_OTHER||least-square means difference|-156.3||||0.0435|TWO_SIDED|95.0|-307.9|-4.6||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|ANOVA|||||-4.6|-307.9|0.0435
71032159|NCT01049334|141573026|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|Wilcoxon (Mann-Whitney)|||||||<.0001
71032160|NCT01049334|141573027|SUPERIORITY_OR_OTHER||least-square means difference|0.1||||0.1448|TWO_SIDED|95.0|0.0|0.1|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 2||0.1|-0.0|0.1448
70972975|NCT02321436|141452971|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.83||||0.0052|TWO_SIDED|95.0|-1.39|-0.26||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 6 (Week 12).||-0.26|-1.39|0.0052
71032161|NCT01049334|141573027|SUPERIORITY_OR_OTHER||least-square means difference|0.1||||0.1538|TWO_SIDED|95.0|0.0|0.3|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 4||0.3|-0.0|0.1538
71094537|NCT02260986|141696811|SUPERIORITY||difference in percentages|9.6||||0.0062|TWO_SIDED|95.0|1.61|17.63||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 2 were considered as non-responders.||17.63|1.61|0.0062
71094538|NCT02260986|141696811|SUPERIORITY||difference in percentages|5.5||||0.0344|TWO_SIDED|95.0|0.56|10.51||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 2 were considered as non-responders.||10.51|0.56|0.0344
71032162|NCT01049334|141573027|SUPERIORITY_OR_OTHER||least-square means difference|0.2||||0.1407|TWO_SIDED|95.0|-0.1|0.5|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 6||0.5|-0.1|0.1407
71094539|NCT02260986|141696812|SUPERIORITY||LS mean difference|-1.81|||<|0.0001|TWO_SIDED|95.0|-2.297|-1.322||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-1.322|-2.297|<0.0001
70920159|NCT05165485|141330831|SUPERIORITY||Mean Difference (Net)|-9.0|||||TWO_SIDED|95.0|-38.0|20.0||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence and stopping after the first failure to reject the null hypothesis. Accordingly, the p-value is not shown.|Mixed Models Analysis||Revefenacin - Tiotropium Least Squares Mean Difference|The OTE is defined as the average of the Day 30, Day 60, and Day 85 Revefenacin - Tiotropium Least Squares Mean differences. The null hypothesis was that the OTE Revefenacin - Tiotropium Least Squares Mean Difference was zero and the alternative hypothesis was that it was nonzero.|The Revefenacin - Tiotropium Least Squares Mean Difference was estimated by fitting a repeated measures mixed model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FEV1, screening FEV1, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|20|-38|
70972976|NCT02321436|141452971|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.52||||0.2037|TWO_SIDED|95.0|-1.35|0.31||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 7 (Week 16).||0.31|-1.35|0.2037
71032163|NCT01049334|141573027|SUPERIORITY_OR_OTHER||least-square means difference|0.2||||0.2906|TWO_SIDED|95.0|-0.2|0.7|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 8||0.7|-0.2|0.2906
71032164|NCT01049334|141573027|SUPERIORITY_OR_OTHER||least-square means difference|0.2||||0.4758|TWO_SIDED|95.0|-0.4|0.8|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 10||0.8|-0.4|0.4758
71032165|NCT01049334|141573027|SUPERIORITY_OR_OTHER||least-square means difference|0.1||||0.6975|TWO_SIDED|95.0|-0.6|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 12||0.9|-0.6|0.6975
71032166|NCT01049334|141573027|SUPERIORITY_OR_OTHER||least-square means difference|0.0||||0.937|TWO_SIDED|95.0|-0.8|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 14||0.9|-0.8|0.9370
71032167|NCT01049334|141573027|SUPERIORITY_OR_OTHER||least-square means difference|-0.1||||0.8493|TWO_SIDED|95.0|-1.1|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 16||0.9|-1.1|0.8493
71032168|NCT01049334|141573027|SUPERIORITY_OR_OTHER||least-square means difference|-0.3||||0.6732|TWO_SIDED|95.0|-1.4|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 18||0.9|-1.4|0.6732
71032169|NCT01049334|141573027|SUPERIORITY_OR_OTHER||least-square means difference|-0.4||||0.5414|TWO_SIDED|95.0|-1.8|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 20||0.9|-1.8|0.5414
71032170|NCT01049334|141573027|SUPERIORITY_OR_OTHER||least-square means difference|-0.6||||0.4313|TWO_SIDED|95.0|-2.1|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 22||0.9|-2.1|0.4313
70972977|NCT02321436|141452971|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.15||||0.7656|TWO_SIDED|95.0|-1.25|0.94||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 8 (Week 20).||0.94|-1.25|0.7656
70972978|NCT02321436|141452971|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.12||||0.8521|TWO_SIDED|95.0|-1.46|1.23||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 9 (Week 24).||1.23|-1.46|0.8521
70972979|NCT02321436|141452971|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.21||||0.6582|TWO_SIDED|95.0|-1.24|0.81||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 10 (Week 28).||0.81|-1.24|0.6582
70972980|NCT02321436|141452972|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|0.8||||0.8754|TWO_SIDED|95.0|-9.5|11.1||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 2 (Week 4).||11.1|-9.5|0.8754
70972981|NCT02321436|141452972|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.9||||0.8805|TWO_SIDED|95.0|-12.8|11.1||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 3 (Week 6).||11.1|-12.8|0.8805
71032171|NCT01049334|141573027|SUPERIORITY_OR_OTHER||least-square means difference|-0.8||||0.3501|TWO_SIDED|95.0|-2.4|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 24||0.9|-2.4|0.3501
71032172|NCT01049334|141573027|SUPERIORITY_OR_OTHER||least-square means difference|-1.0||||0.2679|TWO_SIDED|95.0|-2.8|0.8|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 26||0.8|-2.8|0.2679
71032173|NCT01049334|141573027|SUPERIORITY_OR_OTHER||least-square means difference|-1.2||||0.2137|TWO_SIDED|95.0|-3.2|0.7|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 28||0.7|-3.2|0.2137
71032174|NCT01049334|141573027|SUPERIORITY_OR_OTHER||least-square means difference|-1.5||||0.1715|TWO_SIDED|95.0|-3.6|0.6|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 30||0.6|-3.6|0.1715
71032175|NCT01049334|141573027|SUPERIORITY_OR_OTHER||least-square means difference|-1.8||||0.134|TWO_SIDED|95.0|-4.1|0.5|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 32||0.5|-4.1|0.1340
71032176|NCT01049334|141573027|SUPERIORITY_OR_OTHER||least-square means difference|-2.0||||0.103|TWO_SIDED|95.0|-4.5|0.4|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 34||0.4|-4.5|0.1030
71032177|NCT01049334|141573027|SUPERIORITY_OR_OTHER||least-square means difference|-2.4||||0.0788|TWO_SIDED|95.0|-5.0|0.3|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 36||0.3|-5.0|0.0788
71032178|NCT01049334|141573027|SUPERIORITY_OR_OTHER||least-square means difference|-2.7||||0.062|TWO_SIDED|95.0|-5.5|0.1|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 38||0.1|-5.5|0.0620
71032179|NCT01049334|141573027|SUPERIORITY_OR_OTHER||least-square means difference|-3.0||||0.0476|TWO_SIDED|95.0|-6.0|0.0|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 40||-0.0|-6.0|0.0476
71032180|NCT01049334|141573028|SUPERIORITY_OR_OTHER|||||||0.0273||95.0|||||Log Rank|||||||0.0273
71032181|NCT01049334|141573029|SUPERIORITY_OR_OTHER|||||||0.0098||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0098
71032182|NCT00667095|141573048|SUPERIORITY_OR_OTHER|||||||0.024|||||||t-test, 2 sided|||Change from baseline to 1 month.||||0.024
71032183|NCT00667095|141573048|SUPERIORITY_OR_OTHER|||||||0.036|||||||t-test, 2 sided|||Change from baseline to 3 months.||||0.036
71032184|NCT00667095|141573049|SUPERIORITY_OR_OTHER|||||||0.051|||||||t-test, 2 sided|||Change from baseline to 1 month.||||0.051
71032185|NCT00667095|141573049|SUPERIORITY_OR_OTHER|||||||0.12|||||||t-test, 2 sided|||Change from baseline to 3 months.||||0.12
71032186|NCT00667095|141573050|SUPERIORITY_OR_OTHER|||||||0.42|||||||t-test, 2 sided|||Change from baseline to 1 month.||||0.42
71032187|NCT00667095|141573050|SUPERIORITY_OR_OTHER|||||||0.15|||||||t-test, 2 sided|||Change from baseline to 3 months.||||0.15
71032188|NCT00667095|141573051|SUPERIORITY_OR_OTHER|||||||0.18|||||||t-test, 2 sided|||Change from baseline to 1 month||||0.18
71032189|NCT00667095|141573051|SUPERIORITY_OR_OTHER|||||||0.77|||||||t-test, 2 sided|||Change from baseline to 3 months.||||0.77
71032190|NCT00667095|141573052|SUPERIORITY_OR_OTHER|||||||0.67|||||||t-test, 2 sided|||Change from baseline to one month||||0.67
71032191|NCT00667095|141573052|SUPERIORITY_OR_OTHER|||||||0.2|||||||t-test, 2 sided|||Change from baseline to 3 months.||||0.20
71032192|NCT00667095|141573053|SUPERIORITY_OR_OTHER|||||||0.31|||||||t-test, 2 sided|||Change between baseline and one month||||0.31
71032193|NCT00667095|141573053|SUPERIORITY_OR_OTHER|||||||0.038|||||||t-test, 2 sided|||Change between baseline and 3 months||||0.038
71032194|NCT01832259|141573056|SUPERIORITY|||||||0.345|||||||t-test, 1 sided|||||||0.345
71032195|NCT01832259|141573058|SUPERIORITY|||||||0.46|||||||Log Rank|||||||0.46
71032196|NCT00905346|141573059|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (Test/Ref x 100)|98.39||||||90.0|94.36|102.59|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.59|94.36|
71032197|NCT00905346|141573060|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (Test/Ref x 100)|102.92||||||90.0|99.88|106.05|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.05|99.88|
70972982|NCT02321436|141452972|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-2.2||||0.6992|TWO_SIDED|95.0|-14.0|9.6||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 4 (Week 8).||9.6|-14.0|0.6992
70972983|NCT02321436|141452972|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.1||||0.9882|TWO_SIDED|95.0|-13.0|12.8||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 5 (Week 10).||12.8|-13.0|0.9882
70972984|NCT02321436|141452972|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|4.6||||0.5646|TWO_SIDED|95.0|-11.9|21.2||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 6 (Week 12).||21.2|-11.9|0.5646
71094540|NCT02260986|141696813|SUPERIORITY||LS mean difference|-32.1|||<|0.0001|TWO_SIDED|95.0|-46.37|-17.82||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-17.82|-46.37|<0.0001
70972985|NCT02321436|141452972|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-12.5||||0.2325|TWO_SIDED|95.0|-34.0|9.0||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 7 (Week 16).||9.0|-34.0|0.2325
70972986|NCT02321436|141452972|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-14.1||||0.2441|TWO_SIDED|95.0|-39.4|11.1||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 8 (Week 20).||11.1|-39.4|0.2441
70972987|NCT02321436|141452972|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-9.0||||0.4311|TWO_SIDED|95.0|-33.7|15.7||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 9 (Week 24).||15.7|-33.7|0.4311
70972988|NCT02321436|141452972|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-4.5||||0.731|TWO_SIDED|95.0|-33.3|24.3||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 10 (Week 28).||24.3|-33.3|0.7310
70972989|NCT02321436|141452973|OTHER|||||||0.6128||||||The Cochran-Mantel-Haenszel (CMH) p-value represents the strength of the association between treatment and global assessments of changes at the last visit, adjusted for symptomatic status at baseline.|Cochran-Mantel-Haenszel|p value significance level = 5%||||||0.6128
70972990|NCT00644787|141452977|NON_INFERIORITY_OR_EQUIVALENCE|Difference of 7.5 mm in VAS score was selected as the threshold value for clinical non-inferiority of Fentanyl 1-day transdermal patch to Fentanyl 3-day transdermal patch.|Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-3.5|6.23||||||||6.23|-3.50|
70972991|NCT03048422|141452991|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|6.5|||||TWO_SIDED|95.0|2.0|10.7||||||Difference in proportions for intention-to-treat analysis.||10.7|2.0|
70972992|NCT03048422|141452991|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|6.0|||||TWO_SIDED|95.0|1.6|10.3||||||Difference in proportions for per-protocol analysis.||10.3|1.6|
71094541|NCT02260986|141696814|SUPERIORITY||LS mean difference|-18.38|||<|0.0001|TWO_SIDED|95.0|-22.583|-14.187||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-14.187|-22.583|<0.0001
70972993|NCT03048422|141452991|SUPERIORITY||Risk Difference (RD)|6.5||||0.005|TWO_SIDED|95.0|2.0|10.7|||Wald test of two proportions|||Difference in proportions for superiority and intention-to-treat analysis.||10.7|2.0|0.005
70972994|NCT03048422|141452992|SUPERIORITY||Risk Difference (RD)|-8.8||||0.043|TWO_SIDED|95.0|-17.3|-0.3|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TAF - DTG+FTC/TDF).||-0.3|-17.3|0.043
70972995|NCT03048422|141452992|SUPERIORITY||Risk Difference (RD)|0.2||||0.97|TWO_SIDED|95.0|-8.8|9.1|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TDF - EFV/FTC/TDF).||9.1|-8.8|0.97
70972996|NCT03048422|141452992|SUPERIORITY||Risk Difference (RD)|-8.6||||0.047|TWO_SIDED|95.0|-17.1|-0.1|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TAF - EFV/FTC/TDF).||-0.1|-17.1|0.047
70972997|NCT03048422|141452993|SUPERIORITY||Risk Difference (RD)|-5.6||||0.098|TWO_SIDED|95.0|-14.2|2.9|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Survival probabilities were compared based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms (DTG+FTC/TAF - DTG+FTC/TDF).||2.9|-14.2|0.098
70972998|NCT03048422|141452993|SUPERIORITY||Risk Difference (RD)|2.6||||0.26|TWO_SIDED|95.0|-5.9|11.7|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Survival probabilities were compared based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms (DTG+FTC/TDF-EFV/FTC/TDF).||11.7|-5.9|0.26
70920160|NCT05165485|141330832|SUPERIORITY||Mean Difference (Net)|2.0|||||TWO_SIDED|95.0|-29.0|32.0||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence and stopping after the first failure to reject the null hypothesis. Accordingly, the p-value is not shown.|Mixed Models Analysis||Revefenacin - Tiotropium Least Squares Mean Difference|The null hypothesis was that the Revefenacin - Tiotropium Least Squares Mean Difference was zero and the alternative hypothesis was that it was nonzero.|The Revefenacin - Tiotropium Least Squares Mean Difference was estimated by fitting a repeated measures mixed model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FEV1, screening FEV1, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|32|-29|
70920161|NCT05165485|141330833|SUPERIORITY||Mean Difference (Net)|-6.0|||||TWO_SIDED|95.0|-40.0|29.0||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence and stopping after the first failure to reject the null hypothesis. Accordingly, the p-value is not shown.|Mixed Models Analysis||Revefenacin - Tiotropium Least Squares Mean Difference|The null hypothesis was that the Revefenacin - Tiotropium Least Squares Mean Difference was zero and the alternative hypothesis was that it was nonzero.|The Revefenacin - Tiotropium Least Squares Mean Difference was estimated by fitting a repeated measures mixed model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FEV1, screening FEV1, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|29|-40|
70920162|NCT05165485|141330834|SUPERIORITY||Mean Difference (Net)|-41.0|||||TWO_SIDED|95.0|-118.0|35.0||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence and stopping after the first failure to reject the null hypothesis. Accordingly, the p-value is not shown.|Mixed Models Analysis||Revefenacin - Tiotropium Least Squares Mean Difference.|The null hypothesis was that the Revefenacin - Tiotropium Least Squares Mean Difference was zero and the alternative hypothesis was that it was nonzero.|The Revefenacin - Tiotropium Least Squares Mean Difference was estimated by fitting a repeated measures mixed model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FVC, screening FVC, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|35|-118|
70920163|NCT05165485|141330835|SUPERIORITY||Odds Ratio (OR)|0.6|||||TWO_SIDED|95.0|0.39|0.92||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence and stopping after the first failure to reject the null hypothesis. Accordingly, the p-value is not shown.|Regression, Logistic||The profile likelihood method was used to estimate the Revefenacin / Tiotropium responder OR.|The null hypothesis was that the Revefenacin / Tiotropium responder Odds Ratio was equal to 1 and the alternative hypothesis was that it was not equal to 1.|The Revefenacin / Tiotropium responder OR was estimated by fitting a logistic regression model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FEV1, screening FEV1, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|0.92|0.39|
70920164|NCT05165485|141330836|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.69|1.45||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence and stopping after the first failure to reject the null hypothesis. Accordingly, the p-value is not shown.|Regression, Cox||The profile likelihood method was used to estimate the Revefenacin / Tiotropium HR.|The null hypothesis was that the Revefenacin / Tiotropium CompEx Event Hazard Ratio was equal to 1 and the alternative hypothesis was that it was not equal to 1.|The Revefenacin / Tiotropium HR was estimated by fitting a Cox proportional hazards model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FEV1, screening FEV1, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|1.45|0.69|
70920165|NCT05938413|141330846|NON_INFERIORITY|Non-inferiority test to compare viral suppression rate between month 3 and baseline.|Odds Ratio (OR)|3.01|||||TWO_SIDED|||||||||||||
70920166|NCT03312907|141330856|OTHER||Odds Ratio (OR)|1.27||||0.5342|TWO_SIDED|95.0|0.6|2.71|||Regression, Logistic||Odds ratio was calculated using logistic regression model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose. Belimumab + Standard therapy arm was excluded from model.|||2.71|0.60|0.5342
70920167|NCT03312907|141330856|OTHER||Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.32|1.54|||||Odds ratio was calculated using logistic regression model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, and Baseline prednisone equivalent dose. Belimumab + Placebo arm excluded from model.|||1.54|0.32|
70920168|NCT03312907|141330857|OTHER||Odds Ratio (OR)|1.12||||0.8582|TWO_SIDED|95.0|0.33|3.78|||Regression, Logistic||Odds ratio was calculated using logistic regression model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from model.|||3.78|0.33|0.8582
70920169|NCT03312907|141330857|OTHER||Odds Ratio (OR)|0.53|||||TWO_SIDED|95.0|0.17|1.7|||||Odds ratio was calculated using logistic regression model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm was excluded from model.|||1.70|0.17|
70920170|NCT03312907|141330858|OTHER||Odds Ratio (OR)|1.64||||0.3613|TWO_SIDED|95.0|0.57|4.72|||Regression, Logistic||Odds ratio was calculated using logistic regression model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from model.|||4.72|0.57|0.3613
71094542|NCT02260986|141696815|SUPERIORITY||LS mean difference|-27.7|||<|0.0001|TWO_SIDED|95.0|-33.46|-21.9||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-21.9|-33.46|<0.0001
71094543|NCT02260986|141696816|SUPERIORITY||LS mean difference|-4.2|||<|0.0001|TWO_SIDED|95.0|-5.31|-3.02||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-3.02|-5.31|<0.0001
71094544|NCT02260986|141696817|SUPERIORITY||LS mean difference|-7.4|||<|0.0001|TWO_SIDED|95.0|-8.85|-5.93||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-5.93|-8.85|<0.0001
70920171|NCT03312907|141330858|OTHER||Odds Ratio (OR)|0.45|||||TWO_SIDED|95.0|0.19|1.09|||||Odds ratio was calculated using logistic regression model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm excluded from model.|||1.09|0.19|
70920172|NCT03312907|141330864|OTHER||Hazard Ratio (HR)|0.81||||0.215|TWO_SIDED|95.0|0.57|1.13|||Cox proportional hazards model||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from model.|||1.13|0.57|0.2150
70920173|NCT03312907|141330864|OTHER||Hazard Ratio (HR)|1.64|||||TWO_SIDED|95.0|1.03|2.63|||||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm excluded from model.|||2.63|1.03|
70920174|NCT03312907|141330865|OTHER||Hazard Ratio (HR)|0.87||||0.3757|TWO_SIDED|95.0|0.64|1.19|||Cox proportional hazards model||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from model.|||1.19|0.64|0.3757
70920175|NCT03312907|141330865|OTHER||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.71|1.49|||||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm excluded from model.|||1.49|0.71|
70920176|NCT03312907|141330866|OTHER||Hazard Ratio (HR)|1.55||||0.5127|TWO_SIDED|95.0|0.42|5.78|||Cox proportional hazards model||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from model.|||5.78|0.42|0.5127
70920177|NCT03312907|141330866|OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.23|2.1|||||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm excluded from model.|||2.10|0.23|
70920178|NCT03312907|141330867|OTHER||Hazard Ratio (HR)|0.83||||0.8436|TWO_SIDED|95.0|0.14|5.05|||Cox proportional hazards model||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from model.|||5.05|0.14|0.8436
70920179|NCT03312907|141330867|OTHER||Hazard Ratio (HR)|0.52|||||TWO_SIDED|95.0|0.09|3.14|||||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm excluded from model.|||3.14|0.09|
70920180|NCT03312907|141330874|OTHER||Odds Ratio (OR)|1.55||||0.7102|TWO_SIDED|95.0|0.15|15.7|||Regression, Logistic|Week 52|Odds ratio at Week 52 was calculated using Logistic regression model with covariates:Baseline SLEDAI-2K,Baseline immunosuppressant,Baseline prednisone equivalent dose and treatment group. Belimumab+ Standard therapy arm was excluded from the model.|||15.70|0.15|0.7102
70920181|NCT03312907|141330874|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.1|10.71|||||Odds ratio at Week 52 was calculated using Logistic regression model with covariates:Baseline SLEDAI-2K,Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm was excluded from the model.|||10.71|0.10|
70920182|NCT03312907|141330874|OTHER||Odds Ratio (OR)|0.9||||0.8641|TWO_SIDED|95.0|0.26|3.15|||Regression, Logistic|Week 104|Odds ratio at Week 104 was calculated using Logistic regression model with covariates:Baseline SLEDAI-2K,Baseline immunosuppressant,Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from the model.|||3.15|0.26|0.8641
70920183|NCT03312907|141330874|OTHER||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.26|5.64|||||Odds ratio at Week 104 was calculated using Logistic regression model with covariates:Baseline SLEDAI-2K,Baseline immunosuppressant,Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm was excluded from the model.|||5.64|0.26|
70920184|NCT02576574|141330884|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.007|TWO_SIDED|95.0|0.54|0.93|||Log Rank|||||0.93|0.54|0.0070
70920185|NCT02576574|141330885|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0196|TWO_SIDED|95.0|0.52|0.98|||Log Rank|||||0.98|0.52|0.0196
70920186|NCT02576574|141330886|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.1032|TWO_SIDED|95.0|0.67|1.09|||Log Rank|||||1.09|0.67|0.1032
70920187|NCT02576574|141330887|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.063|TWO_SIDED|95.0|0.59|1.07|||Log Rank|||||1.07|0.59|0.0630
70920188|NCT02576574|141330888|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0147|TWO_SIDED|95.0|0.62|0.98|||Log Rank|||||0.98|0.62|0.0147
70920189|NCT02576574|141330889|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1753|TWO_SIDED|95.0|0.67|1.15|||Log Rank|||||1.15|0.67|0.1753
70920190|NCT02576574|141330890|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0257|TWO_SIDED|95.0|0.66|1.0|||Log Rank|||||1.00|0.66|0.0257
70920191|NCT02576574|141330891|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0809|TWO_SIDED|95.0|0.66|1.07|||Log Rank|||||1.07|0.66|0.0809
70972999|NCT03048422|141452993|SUPERIORITY||Risk Difference (RD)|-2.8||||0.26|TWO_SIDED|95.0|-11.3|5.8|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Survival probabilities were compared based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms (DTG+FTC/TAF-EFV/FTC/TDF).||5.8|-11.3|0.26
70973000|NCT03048422|141452994|SUPERIORITY||Risk Difference (RD)|-3.2||||0.25|TWO_SIDED|95.0|-12.8|6.3|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimated difference of DTG+FTC/TAF - DTG+FTC/TDF.||6.3|-12.8|0.25
70920192|NCT02576574|141330892|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.1294|TWO_SIDED|95.0|0.78|1.07|||Log Rank|||||1.07|0.78|0.1294
70920193|NCT02576574|141330893|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.2618|TWO_SIDED|95.0|0.79|1.13|||Log Rank|||||1.13|0.79|0.2618
70920194|NCT02576574|141330894|SUPERIORITY||Odds Ratio (OR)|1.41||||0.064|TWO_SIDED|95.0|0.91|2.18|||Cochran-Mantel-Haenszel|||||2.18|0.91|0.0640
70920195|NCT02576574|141330895|SUPERIORITY||Odds Ratio (OR)|1.23||||0.2217|TWO_SIDED|95.0|0.73|2.07|||Cochran-Mantel-Haenszel|||||2.07|0.73|0.2217
70920196|NCT02576574|141330896|SUPERIORITY||Odds Ratio (OR)|1.18||||0.1912|TWO_SIDED|95.0|0.81|1.72|||Cochran-Mantel-Haenszel|||||1.72|0.81|0.1912
70920197|NCT02576574|141330897|SUPERIORITY||Odds Ratio (OR)|1.0||||0.4951|TWO_SIDED|95.0|0.64|1.57|||Cochran-Mantel-Haenszel|||||1.57|0.64|0.4951
70920198|NCT02980276|141330916|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|-6.9||||0.13|TWO_SIDED|95.0|-15.1|1.4||The primary analysis, as per sample size calculation, was a two-sample comparison of reduction in the proportion of women needing insulin between treatment and control arms using an exact test for a binomial response.|Risk difference||Units are %|The primary analysis, as per sample size calculation, was a two-sample comparison of reduction in the proportion of women needing insulin between treatment and control arms using an exact test for a binomial response.||1.4|-15.1|0.13
70920199|NCT02980276|141330917|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|-12.7||||0.004|TWO_SIDED|95.0|-21.2|-4.3|||Risk difference||Units are %|||-4.3|-21.2|0.004
70920200|NCT02980276|141330918|SUPERIORITY|||||||0.001|||||||Log Rank|Median survival times could not be calculated; time to insulin initiation would be censored at delivery in \>50% of participants in treatment group.||||||0.001
70920201|NCT02980276|141330919|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio, log|0.61||||0.005|TWO_SIDED|95.0|0.43|0.86|||Regression, Logistic|Unadjusted|Unadjusted|||0.86|0.43|0.005
70920202|NCT02980276|141330919|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.56||||0.003|TWO_SIDED|95.0|0.38|0.82|||Regression, Logistic|Adjusted|Adjusted|||0.82|0.38|0.003
70920203|NCT02980276|141330920|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.78||||0.178|TWO_SIDED|95.0|0.55|1.12|||Regression, Logistic||Unadjusted|||1.12|0.55|0.178
70920204|NCT02980276|141330920|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.72||||0.105|TWO_SIDED|95.0|0.48|1.07||Two-sided test comparing observed odds ratio to 1.|Regression, Logistic||Adjusted|||1.07|0.48|0.105
70920205|NCT02980276|141330921|EQUIVALENCE|Two-sided test comparing observed mean difference to zero.|Mean Difference (Final Values)|-3.7||||0.17|TWO_SIDED|95.0|-9.3|1.7|||t-test, 2 sided|||||1.7|-9.3|0.17
70920206|NCT02980276|141330922|EQUIVALENCE|Two-sided test comparing observed mean difference ratio to zero.|Mean Difference (Final Values)|-1.2||||0.003|TWO_SIDED|95.0|-1.99|-0.42|||t-test, 2 sided|||||-0.42|-1.99|0.003
70920207|NCT02980276|141330923|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|1.21||||0.99|TWO_SIDED|95.0|0.65|1.55|||Regression, Logistic|||||1.55|0.65|0.99
70920208|NCT02980276|141330924|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.96||||0.911|TWO_SIDED|95.0|0.46|2.0|||Regression, Logistic|||||2|0.46|0.911
70920209|NCT02980276|141330925|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.82||||0.519|TWO_SIDED|95.0|0.44|1.51|||Regression, Logistic|||||1.51|0.44|0.519
70920210|NCT02980276|141330926|EQUIVALENCE|Two-sided test comparing observed mean difference to zero.|Mean Difference (Final Values)|0.0||||0.66|TWO_SIDED|95.0|-0.3|0.2|||t-test, 2 sided|||||0.2|-0.3|0.66
70920211|NCT02980276|141330927|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|1.21||||0.367|TWO_SIDED|95.0|0.8|1.85|||Regression, Logistic|Unadjusted|Unadjusted|||1.85|0.8|0.367
70920212|NCT02980276|141330927|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|1.22||||0.359|TWO_SIDED|95.0|0.8|1.87|||Regression, Logistic|Adjusted|Adjusted|||1.87|0.8|0.359
70920213|NCT02980276|141330928|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|-6.5||||1|TWO_SIDED|95.0|-13.9|12.9|||Risk difference||Units are %|||12.9|-13.9|1.0
70920214|NCT02980276|141330929|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.89||||0.603|TWO_SIDED|95.0|0.56|1.39|||Regression, Logistic|Unadjusted|Unadjusted|||1.39|0.56|0.603
70920215|NCT02980276|141330929|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.89||||0.621|TWO_SIDED|95.0|0.57|1.4|||Regression, Logistic|Adjusted|Adjusted|||1.4|0.57|0.621
70920216|NCT02980276|141330930|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.89||||0.739|TWO_SIDED|95.0|0.45|1.76|||Regression, Logistic|Unadjusted|Unadjusted|||1.76|0.45|0.739
70920217|NCT02980276|141330930|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.92||||0.812|TWO_SIDED|95.0|0.46|1.84|||Regression, Logistic|Adjusted|Adjusted|||1.84|0.46|0.812
70920218|NCT02980276|141330931|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|1.84||||0.282|TWO_SIDED|95.0|0.63|6.04|||Regression, Logistic|Unadjusted|Unadjusted|Unadjusted||6.04|0.63|0.282
70920219|NCT02980276|141330931|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|2.14||||0.196|TWO_SIDED|95.0|0.7|7.38|||Regression, Logistic||Adjusted|||7.38|0.7|0.196
70973001|NCT03048422|141452994|SUPERIORITY||Risk Difference (RD)|-2.3||||0.32|TWO_SIDED|95.0|-12.1|7.5|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimate of risk difference DTG+FTC/TDF-EFV/FTC/TDF.||7.5|-12.1|0.32
71032198|NCT00905346|141573061|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (Test/Ref x 100)|102.63||||||90.0|99.24|106.14|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.14|99.24|
71032199|NCT04000815|141573093|OTHER||||||<|0.017||||||p-value is adjusted for multiple comparisons|Kruskal-Wallis|||||||<0.017
71032200|NCT04000815|141573094|OTHER||||||<|0.05|||||||Bi-variate correlation analysis|Bi-variate correlation analyses were performed in groups 1 and 2 between serum CNP and FSH and between serum CNP and LH using Spearman test.||||||<0.05
71032201|NCT04000815|141573095|OTHER||||||<|0.05|||||||Bi-variate correlation|Spearman test was applied.||||||<0.05
71032202|NCT04000815|141573096|OTHER||||||<|0.05|||||||Bi-variate correlation analyses|Bi-variate correlation analyses were performed for all subjects in groups 1 and 2 between serum CNP and E2 using Spearman test.||||||<0.05
71032203|NCT03988803|141573130|OTHER||Ratio of the geometric means (T/R1)|94.8|STANDARD_ERROR_OF_MEAN|12.2|||TWO_SIDED|90.0|87.14|103.14|||ANOVA||Standard error of the mean is the geometric coefficient of variation|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That was, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. The model used included effects accounting for the following sources of variation: subjects and treatment. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||103.14|87.14|
71032204|NCT03988803|141573131|OTHER||Ratio of the geometric means (T/R1)|99.34|STANDARD_ERROR_OF_MEAN|12.3|||TWO_SIDED|90.0|91.22|108.18|||ANOVA||Standard error fo the mean is the geometric coefficient of variation|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That was, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. The model used included effects accounting for the following sources of variation: subjects and treatment. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||108.18|91.22|
71032205|NCT03988803|141573132|OTHER||Ratio of the geometric means (T/R2)|103.69|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|90.0|99.99|107.52|||ANOVA||Standard error fo the mean is the geometric coefficient of variation|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That was, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. The model used included effects accounting for the following sources of variation: subjects and treatment. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||107.52|99.99|
71032206|NCT03988803|141573133|OTHER||Ratio of the geometric means (T/R2)|107.45|STANDARD_ERROR_OF_MEAN|6.5|||TWO_SIDED|90.0|102.66|112.45|||ANOVA||Standard error fo the mean is the geometric coefficient of variation|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That was, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. The model used included effects accounting for the following sources of variation: subjects and treatment. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||112.45|102.66|
71032207|NCT00840099|141573140|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of Means x 100|100.91||||||90.0|95.82|106.26|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||106.26|95.82|
71032208|NCT00840099|141573141|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|102.79||||||90.0|100.69|104.94|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.94|100.69|
71032209|NCT00840099|141573142|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|102.75||||||90.0|100.62|104.93|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.93|100.62|
71032210|NCT00840099|141573143|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the Mean x 100|100.47||||||90.0|93.28|108.2|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||108.20|93.28|
71032211|NCT00840099|141573144|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Ratio of the mean|104.15||||||90.0|96.35|112.58|||||Bioequivalence is established when 80% Confidence Interval falls within 80 - 125|||112.58|96.35|
71032212|NCT00840099|141573145|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|104.06||||||90.0|95.85|112.97|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||112.97|95.85|
71094545|NCT02260986|141696818|SUPERIORITY||LS mean difference|-1.0||||0.1596|TWO_SIDED|95.0|-2.27|0.37||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||0.37|-2.27|0.1596
71032213|NCT01032083|141573173|EQUIVALENCE|For the primary outcome, linear regression was used to determine mean difference between treatment groups. Differences between groups are presented as mean differences with associated 95% confidence interval (CI). Baseline values for variables were included as covariates in regression models and adjusted according to analysis of covariance. All analyses were conducted under the intention-to-treat principle.|Mean Difference (Final Values)|-1.54||||0.36|TWO_SIDED|95.0|-4.91|1.8|||Regression, Linear|||||1.80|-4.91|0.36
71032214|NCT01032083|141573174|EQUIVALENCE|For the primary outcome, linear regression was used to determine mean difference between treatment groups. Differences between groups are presented as mean differences with associated 95% confidence interval (CI). Baseline values for variables were included as covariates in regression models and adjusted according to analysis of covariance. All analyses were conducted under the intention-to-treat principle.|Mean Difference (Final Values)|2.4||||0.68|TWO_SIDED|95.0|-9.0|14.0|||Regression, Linear|||||14|-9|0.68
71032215|NCT03450057|141573194|OTHER|The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.|||||||||||||||||The PFS function was estimated using the Kaplan-Meier product-limit method. Median and two-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.|||
71094546|NCT01771913|141696868|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.310
71094547|NCT01771913|141696869|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.026
71094548|NCT01771913|141696870|SUPERIORITY_OR_OTHER|||||||0.103|TWO_SIDED||||||Fisher Exact|||||||0.103
71094549|NCT04900272|141696878|OTHER|||||||0.785|||||||ANOVA|||||||0.785
71094550|NCT04900272|141696879|OTHER|||||||0.583|||||||ANOVA|||||||0.583
71094551|NCT04900272|141696880|OTHER|||||||0.5015|||||||ANOVA|||||||0.5015
71094552|NCT04900272|141696881|OTHER|||||||0.3536|||||||ANOVA|||||||0.3536
71094553|NCT04900272|141696882|OTHER|||||||0.2688|||||||ANOVA|||||||0.2688
71094554|NCT04900272|141696883|OTHER|||||||0.728|||||||ANOVA|||||||0.728
71094555|NCT04900272|141696884|OTHER|||||||0.473|||||||ANOVA|||||||0.473
71094556|NCT04900272|141696885|OTHER|||||||0.4161|||||||ANOVA|||||||0.4161
71094557|NCT04900272|141696886|OTHER|||||||0.3356|||||||ANOVA|||||||0.3356
71094558|NCT04900272|141696887|OTHER|||||||0.9825|||||||ANOVA|||||||0.9825
71094559|NCT04327271|141696955|NON_INFERIORITY|Non-inferiority margin of -0.25% set as lower bound of 95% CI for the maximum mean difference between the proportion of cumulative AEs between control and 2wT arms to conclude that 2wT is non-inferior. This margin was set considering the average AE rate of 0.5% from routine SSA MC programs at scale, and assuming that 2wT increases AE ascertainment to 2.0%, similar to 1.9% of Zimbabwe RCT and the widely-accepted standard 2% AE rate.|Mean Difference (Final Values)|1.2|||||ONE_SIDED|95.0|-0.09|||||||With 10% loss to follow-up (LTFU), a sample size of 1104 men provides at least 80% power to rule out a decrease in AE ascertainment of more than 0.25% based on the lower bound of the one-sided 95% CI. The one tailed alpha was set 0.05.|||-.09|
71094560|NCT04327271|141696956|SUPERIORITY||Mean Difference (Final Values)|1.12||||0.001|TWO_SIDED|95.0|1.03|1.21|||Fisher Exact|||The mean number of in-person clinic visit, excluding non-study visits, were compared between the two arms using a t-test. The proportion of potential AEs was calculated as number of potential AE responses divided by the total number of daily responses (no AE and potential AE). A superiority test was performed on the safety outcomes using a two-sided 95% confidence interval and p-value using Fisher's exact test.||1.21|1.03|0.001
71094561|NCT01479530|141696973|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0228|TWO_SIDED|95.0|-0.92|-0.07|||ANCOVA|||||-0.07|-0.92|0.0228
71094562|NCT01479530|141696974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.61|-0.22|||ANCOVA|||||-0.22|-0.61|<0.0001
71094563|NCT01479530|141696975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|0.37||0.0075|TWO_SIDED|95.0|-1.75|-0.27|||ANCOVA|||||-0.27|-1.75|0.0075
71094564|NCT01479530|141696976|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|0.74||0.0317|TWO_SIDED|95.0|-3.05|-0.14|||ANCOVA|||||-0.14|-3.05|0.0317
71094565|NCT00303628|141696977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.876|TWO_SIDED|||||Stratified log rank test. The above P value was for one-sided test|Log Rank|||||||0.876
71094566|NCT00303628|141696978|SUPERIORITY_OR_OTHER_LEGACY|||||||0.299|TWO_SIDED|||||two-sided stratified log rank test p value|Log Rank|||||||0.299
71094567|NCT03487445|141697014|SUPERIORITY|The statistical analysis comprised a 2-step testing strategy. The first test, carried out at an alpha level of 0.025, determined whether the proportion of responders (patients with a PRU value \<100) was ≥ 50% (null hypothesis: proportion of responders \<50%) and is reported below. The second step for the Selatogrel 8 mg is described in statistical analysis 2: In this second analysis the subsequent null hypothesis of treatment effect less or equal to 85% was tested for the 8 mg dose.|||||<|0.001||||||P-value for hypotheses (H0: p \<= 50% vs. H1: p \> 50%)|one-sided z-test|A p-value significance level was set to 0.025.||The main analysis (mFAS, treatment dose as received) of treatment effect on the primary endpoint was conducted independently for each dose.||||<0.001
71094568|NCT03487445|141697014|SUPERIORITY|This statistical analysis reports the second of the 2-step testing strategy. This second test for the 8 mg Selatogrel dose, carried out at an alpha level of 0.025, determined whether the proportion of responders (patients with a PRU value \<100) was ≥ 85% (null hypothesis: proportion of responders \<85%).||||||0.142||||||P-value for hypotheses (H0: p \<= 85% vs. H1: p \> 85%)|one-sided z-test|A p-value significance level was set to 0.025, an overall level of 0.05 and adjusted for multiplicity using the Bonferroni approach.||The main analysis (mFAS, treatment dose as received) of treatment effect on the primary endpoint was conducted independently for each dose.||||0.142
71094569|NCT03487445|141697014|SUPERIORITY|The statistical analysis comprised a 2-step testing strategy. The first test, carried out at an alpha level of 0.025, determined whether the proportion of responders (patients with a PRU value \<100) was ≥ 50% (null hypothesis: proportion of responders \<50%) and is reported below. The second step for the Selatogrel 16 mg is described in statistical analysis 4: In this second analysis the subsequent null hypothesis of treatment effect less or equal to 85% was tested for the 16 mg dose.|||||<|0.0001||||||P-value for hypotheses (H0: p \<= 50% vs. H1: p \> 50%)|one-sided z-test|A p-value significance level was set to 0.025.||The main analysis (mFAS, treatment dose as received) of treatment effect on the primary endpoint was conducted independently for each dose.||||<0.0001
71094570|NCT03487445|141697014|SUPERIORITY|This statistical analysis reports the second of the 2-step testing strategy. This second test for the 16 mg Selatogrel dose, carried out at an alpha level of 0.025, determined whether the proportion of responders (patients with a PRU value \<100) was ≥ 85% (null hypothesis: proportion of responders \<85%).||||||0.009||||||P-value for hypotheses (H0: p \<= 85% vs. H1: p \> 85%)|one-sided z-test|A p-value significance level was set to 0.025, an overall level of 0.05 and adjusted for multiplicity using the Bonferroni approach.||The main analysis (mFAS, treatment dose as received) of treatment effect on the primary endpoint was conducted independently for each dose.||||0.009
71094571|NCT03487445|141697015|SUPERIORITY|||||||0.228||||||P-value for hypotheses (H0: p \<= 85% versus H1: p \> 85%)|One-sided Z-test|||As per the main analysis (mFAS) the supporting analysis on the per-protocol set this analysis of treatment effect was conducted independently for each dose, i.e., 8 and 16 mg.||||0.2280
71094572|NCT03487445|141697015|SUPERIORITY|||||||0.0201||||||P-value for hypotheses (H0: p \<= 85% versus H1: p \> 85%)|One-sided Z-test|||As per the main analysis (mFAS) the supporting analysis on the per-protocol set this analysis of treatment effect was conducted independently for each dose, i.e., 8 and 16 mg.||||0.0201
70920220|NCT02980276|141330932|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.53||||0.058|TWO_SIDED|95.0|0.27|1.01|||Regression, Logistic|Unadjusted||||1.01|0.27|0.058
71032216|NCT03450057|141573195|OTHER|The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.|||||||||||||||||The PFS function was estimated using the Kaplan-Meier product-limit method. Median and two-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.|||
70920221|NCT02980276|141330932|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.53||||0.061|TWO_SIDED|95.0|0.27|1.02|||Regression, Logistic|Adjusted||||1.02|0.27|0.061
70920222|NCT02980276|141330933|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|-4.5||||0.24|TWO_SIDED|95.0|-11.6|2.5|||Risk difference||Units are %|||2.5|-11.6|0.24
70920223|NCT02980276|141330933|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|0.81||||0.24|TWO_SIDED|95.0|0.59|1.12|||Regression, Logistic||Units are %|||1.12|0.59|0.24
70920224|NCT02980276|141330934|EQUIVALENCE|Regression model that adjusts for the infant's sex and maternal height and weight at randomization.|Median Difference (Final Values)|-113.0||||0.005|TWO_SIDED|95.0|-201.0|-24.0|||Regression, Linear|P value was derived from a statistical model that adjusts for the infant's sex and maternal height and weight at randomization.||||-24|-201|0.005
70920225|NCT02980276|141330935|EQUIVALENCE|Two-sided test comparing observed mean difference to zero.|Mean Difference (Final Values)|0.0||||0.82|TWO_SIDED|95.0|-0.3|0.3|||t-test, 2 sided|||||0.3|-0.3|0.82
70920226|NCT02980276|141330936|EQUIVALENCE|Two-sided test comparing observed mean difference to zero.|Mean Difference (Final Values)|-0.7||||0.02|TWO_SIDED|95.0|-1.3|-0.2|||t-test, 2 sided|||||-0.2|-1.3|0.02
70920227|NCT02980276|141330937|EQUIVALENCE|Two-sided test comparing observed mean difference to zero.|Mean Difference (Final Values)|0.1||||0.72|TWO_SIDED|95.0|-0.5|0.7|||t-test, 2 sided|||||0.7|-0.5|0.72
70920228|NCT02980276|141330938|EQUIVALENCE|Two-sided test comparing observed mean difference to zero.|Mean Difference (Final Values)|0.0||||0.68|TWO_SIDED|95.0|-0.1|0.1|||t-test, 2 sided|||||0.1|-0.1|0.68
70920229|NCT02980276|141330939|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|-7.2||||0.02|TWO_SIDED|95.0|-12.6|-1.8|||Regression, Logistic|P value derived from a statistical model that adjusts for the infant's sex, gestational age at birth, and maternal height and weight at randomization.|P value derived from a statistical model that adjusts for the infant's sex, gestational age at birth, and maternal height and weight at randomization.|||-1.8|-12.6|0.02
70920230|NCT02980276|141330940|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|-8.4||||0.003|TWO_SIDED|95.0|-13.7|-3.2|||Risk difference|P value derived from a statistical model that adjusts for the infant's sex and maternal height and weight at randomization|Units are %|||-3.2|-13.7|0.003
70920231|NCT02980276|141330941|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|2.7||||0.012|TWO_SIDED|95.0|-1.0|6.3|||Risk difference|Units are %. P value derived from model adjusting for the gestational age at birth, sex and maternal height and weight at randomization.|Units are %. P value was derived from a statistical model that adjusts for the infant's gestational age at birth, sex and maternal height and weight at randomization.|||6.3|-1|.012
70920232|NCT02980276|141330942|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|3.0||||0.13|TWO_SIDED|95.0|-0.4|6.5||Units are %. P value was derived from a statistical model that adjusts for the infant's gestational age at birth, sex and maternal height and weight at randomization.|Regression, Logistic||Units are %. P value was derived from a statistical model that adjusts for the infant's gestational age at birth, sex and maternal height and weight at randomization.|||6.5|-0.4|0.13
70920233|NCT02980276|141330943|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|3.0||||0.38|TWO_SIDED|95.0|-2.9|9.0|||Risk difference||Units are %.|||9|-2.9|0.38
70920234|NCT02980276|141330944|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|2.8||||0.33|TWO_SIDED|95.0|-2.0|7.3|||Risk difference||Units are %|||7.3|-2.0|0.33
70920235|NCT02980276|141330945|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|2.3||||0.42|TWO_SIDED|95.0|-2.4|6.9|||Risk difference||Units are %|||6.9|-2.4|0.42
70920236|NCT02980276|141330946|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|0.4|||>|0.99|TWO_SIDED|95.0|-0.4|1.1|||Risk difference||Units are %.|||1.1|-0.4|>0.99
70920237|NCT02980276|141330947|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|1.1||||0.62|TWO_SIDED|95.0|-1.9|4.2|||Risk difference||Units are %|||4.2|-1.9|0.62
70920238|NCT02980276|141330948|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|0.0|||>|0.99|TWO_SIDED|95.0|-1.0|1.0|||Risk difference||Units are %|||1|-1|>0.99
70920239|NCT02980276|141330949|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|0.7||||0.9|TWO_SIDED|95.0|-5.1|6.6|||Risk difference||Units are %|||6.6|-5.1|0.9
70920240|NCT01780298|141330956|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-36.278|||<|0.0001|TWO_SIDED|95.0|-42.203|-30.352|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||-30.352|-42.203|<0.0001
70920241|NCT01780298|141330956|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-32.739|||<|0.0001|TWO_SIDED|95.0|-38.418|-27.06|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||-27.060|-38.418|<0.0001
70920242|NCT01780298|141330956|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-25.265|||<|0.0001|TWO_SIDED|95.0|-31.081|-19.449|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||-19.449|-31.081|<0.0001
70920243|NCT01780298|141330956|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.538||||0.1504|TWO_SIDED|95.0|-8.398|1.321|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||1.321|-8.398|0.1504
70973002|NCT03048422|141452994|SUPERIORITY||Risk Difference (RD)|-5.5||||0.11|TWO_SIDED|95.0|-14.3|3.2|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimate of risk difference DTG+FTC/TAF-EFV/FTC/TDF.||3.2|-14.3|0.11
70973003|NCT03048422|141452995|SUPERIORITY||Risk Difference (RD)|15.6|||<|0.0001|TWO_SIDED|95.0|9.3|22.0|||Wald test of two proportions|||Difference in proportions between arms for intention-to-treat analysis with null hypothesis of no difference (DTG groups - EFV/FTC/TDF).||22.0|9.3|< 0.0001
70973004|NCT03048422|141452996|SUPERIORITY||Risk Difference (RD)|-0.1||||0.97|TWO_SIDED|95.0|-3.3|3.2|||Wald test of two proportions|||Difference in proportions for intention-to-treat analysis with null hypothesis of no difference between arms (DTG arms - EFV/FTC/TDF).||3.2|-3.3|0.97
70973005|NCT03048422|141452997|SUPERIORITY||Hazard Ratio (HR)|2.4|||<|0.001|TWO_SIDED|95.0|1.9|3.1|||Kaplan-Meier|||||3.1|1.9|< 0.001
70973006|NCT03048422|141452998|SUPERIORITY||Risk Difference (RD)|3.6||||0.19|TWO_SIDED|95.0|-1.8|9.1|||Wald test of two proportions|||Difference between arms with null hypothesis of no difference (DTG+FTC/TAF - DTG+FTC/TDF).||9.1|-1.8|0.19
70973007|NCT03048422|141452998|SUPERIORITY||Risk Difference (RD)|-11.5|||<|0.001|TWO_SIDED|95.0|-17.9|-5.2|||Wald test of two proportions|||Difference between arms with null hypothesis of no difference (DTG+FTC/TDF - EFV/FTC/TDF).||-5.2|-17.9|< 0.001
70973008|NCT03048422|141452998|SUPERIORITY||Risk Difference (RD)|-7.9||||0.022|TWO_SIDED|95.0|-14.6|-1.2|||Wald test of two proportions|||Difference between arms with null hypothesis of no difference (DTG+FTC/TAF - EFV/FTC/TDF).||-1.2|-14.6|0.022
70973009|NCT03048422|141452999|SUPERIORITY||Risk Difference (RD)|2.1||||0.61|TWO_SIDED|95.0|-5.9|10.1|||Wald test of two proportions|||Difference between arms with null hypothesis of no difference (DTG+FTC/TAF - DTG+FTC/TDF).||10.1|-5.9|0.61
70973010|NCT03048422|141452999|SUPERIORITY||Risk Difference (RD)|-1.4||||0.74|TWO_SIDED|95.0|-9.4|6.6|||Wald test of two proportions|||Difference between arms with null hypothesis of no difference (DTG+FTC/TDF - EFV/FTC/TDF).||6.6|-9.4|0.74
70973011|NCT03048422|141452999|SUPERIORITY||Risk Difference (RD)|0.7||||0.86|TWO_SIDED|95.0|-7.4|8.8|||Wald test of two proportions|||Difference between arms with null hypothesis of no difference (DTG+FTC/TAF - EFV/FTC/TDF).||8.8|-7.4|0.86
71094573|NCT00221104|141697021|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.8234|TWO_SIDED|95.0|0.73|1.29|||Stratified log-rank test|log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)||1.29|0.73|0.8234
70973012|NCT03048422|141453000|SUPERIORITY||Risk Difference (RD)|4.3||||0.27|TWO_SIDED|95.0|-3.4|11.9|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG groups - EFV/FTC/TDF).||11.9|-3.4|0.27
71032217|NCT03450057|141573196|OTHER|The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.|||||||||||||||||The PFS function was estimated using the Kaplan-Meier product-limit method. Median and two-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.|||
70973013|NCT03048422|141453001|SUPERIORITY||Risk Difference (RD)|-0.1||||0.49|TWO_SIDED|95.0|-7.6|7.5|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimate of risk difference combined DTG arms-EFV/FTC/TDF.||7.5|-7.6|0.49
70973014|NCT03048422|141453002|SUPERIORITY||Risk Difference (RD)|4.1||||0.15|TWO_SIDED|95.0|-3.8|12.0|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimated difference of combined DTG arms - EFV/FTC/TDF.||12.0|-3.8|0.15
70973015|NCT03048422|141453003|SUPERIORITY||Risk Difference (RD)|-8.8||||0.043|TWO_SIDED|95.0|-17.3|-0.3|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TAF - DTG+FTC/TDF).||-0.3|-17.3|0.043
70973016|NCT03048422|141453003|SUPERIORITY||Risk Difference (RD)|-0.3||||0.95|TWO_SIDED|95.0|-9.3|8.6|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TDF - EFV/FTC/TDF).||8.6|-9.3|0.95
70973017|NCT03048422|141453003|SUPERIORITY||Risk Difference (RD)|-9.1||||0.037|TWO_SIDED|95.0|-17.6|-0.6|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TAF - EFV/FTC/TDF).||-0.6|-17.6|0.037
70973018|NCT03048422|141453004|SUPERIORITY||Odds Ratio (OR)|0.73||||0.095|TWO_SIDED|95.0|0.5|1.06|||Regression, Ordinal|||Null hypothesis of odds ratio equal to 1, with odds of experiencing a worse outcome equal between groups (DTG+FTC/TAF - DTG+FTC/TDF).||1.06|0.50|0.095
70973019|NCT03048422|141453004|SUPERIORITY||Odds Ratio (OR)|0.83||||0.3|TWO_SIDED|95.0|0.58|1.19|||Regression, Ordinal|||Null hypothesis of odds ratio equal to 1, with odds of experiencing a worse outcome equal between groups (DTG+FTC/TDF - EFV/FTC/TDF).||1.19|0.58|0.30
70973020|NCT03048422|141453004|SUPERIORITY||Odds Ratio (OR)|0.6||||0.008|TWO_SIDED|95.0|0.42|0.88|||Regression, Ordinal|||Null hypothesis of odds ratio equal to 1, with odds of experiencing a worse outcome equal between groups (DTG+FTC/TAF - EFV/FTC/TDF).||0.88|0.42|0.008
70973021|NCT03048422|141453005|SUPERIORITY||Risk Difference (RD)|0.5||||0.28|TWO_SIDED|95.0|-1.2|2.1|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Survival probabilities were compared based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms (DTG+FTC/TAF - DTG+FTC/TDF).||2.1|-1.2|0.28
70973022|NCT03048422|141453005|SUPERIORITY||Risk Difference (RD)|-0.1||||0.47|TWO_SIDED|95.0|-1.5|1.4|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Survival probabilities were compared based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms (DTG+FTC/TDF - EFV/FTC/TDF).||1.4|-1.5|0.47
71094574|NCT00221104|141697022|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.0047|TWO_SIDED|95.0|0.15|0.74|||Stratified log-rank test|log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)||0.74|0.15|0.0047
70973023|NCT03048422|141453005|SUPERIORITY||Risk Difference (RD)|0.4||||0.31|TWO_SIDED|95.0|-1.3|2.2|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Survival probabilities were compared based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms (DTG+FTC/TAF - EFV/FTC/TDF).||2.2|-1.3|0.31
70973024|NCT03048422|141453006|SUPERIORITY|The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimated difference of DTG+FTC/TAF - DTG+FTC/TDF.|Risk Difference (RD)|-1.0||||0.2|TWO_SIDED|95.0|-3.4|1.3|||Z-test|||||1.3|-3.4|0.20
70973025|NCT03048422|141453006|SUPERIORITY||Risk Difference (RD)|-4.9||||0.008|TWO_SIDED|95.0|-8.9|-0.9|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimate of risk difference DTG+FTC/TDF-EFV/FTC/TDF.||-0.9|-8.9|0.008
70973026|NCT03048422|141453006|SUPERIORITY||Risk Difference (RD)|-5.9|||<|0.001|TWO_SIDED|95.0|-9.7|-2.2|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimate of risk difference DTG+FTC/TAF-EFV/FTC/TDF.||-2.2|-9.7|<0.001
70973027|NCT03048422|141453007|SUPERIORITY||Mean Difference (Final Values)|-0.093||||0.12|TWO_SIDED|95.0|-0.208|0.023|||Generalized Estimating Equation|||Null hypothesis of no difference in weekly change in creatinine clearance from baseline (DTG+FTC/TAF - DTG+FTC/TDF).||0.023|-0.208|0.12
70973028|NCT03048422|141453007|SUPERIORITY||Mean Difference (Final Values)|0.048||||0.39|TWO_SIDED|95.0|-0.061|0.158|||Generalized Estimating Equation|||Null hypothesis of no difference in weekly change in creatinine clearance from baseline (DTG+FTC/TDF - EFV/FTC/TDF).||0.158|-0.061|0.39
70973029|NCT03048422|141453007|SUPERIORITY||Mean Difference (Final Values)|-0.045||||0.45|TWO_SIDED|95.0|-0.161|0.072|||Generalized Estimating Equation|||Null hypothesis of no difference in weekly change in creatinine clearance from baseline (DTG+FTC/TAF - EFV/FTC/TDF).||0.072|-0.161|0.45
70973030|NCT03048422|141453008|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.94|TWO_SIDED|95.0|-11.3|10.5|||t-test, 2 sided|||Null hypothesis of no difference between arms at delivery (DTG+FTC/TAF - DTG+FTC/TDF).||10.5|-11.3|0.94
70973031|NCT03048422|141453008|SUPERIORITY||Mean Difference (Final Values)|4.2||||0.44|TWO_SIDED|95.0|-6.5|14.9|||t-test, 2 sided|||Null hypothesis of no difference between arms at delivery (DTG+FTC/TDF - EFV/FTC/TDF).||14.9|-6.5|0.44
70973032|NCT03048422|141453008|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.18|TWO_SIDED|95.0|-1.8|9.3|||t-test, 2 sided|||Null hypothesis of no difference between arms at delivery (DTG+FTC/TAF - EFV/FTC/TDF).||9.3|-1.8|0.18
70973033|NCT03048422|141453008|SUPERIORITY||Mean Difference (Final Values)|11.1||||0.27|TWO_SIDED|95.0|-8.9|31.1|||t-test, 2 sided|||Null hypothesis of no difference between arms at week 26 (DTG+FTC/TAF - DTG+FTC/TDF).||31.1|-8.9|0.27
70973034|NCT03048422|141453008|SUPERIORITY||Mean Difference (Final Values)|-11.4||||0.048|TWO_SIDED|95.0|-22.6|-0.1|||t-test, 2 sided|||Null hypothesis of no difference between arms at week 26 (DTG+FTC/TDF - EFV/FTC/TDF).||-0.1|-22.6|0.048
70973035|NCT03048422|141453008|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.98|TWO_SIDED|95.0|-21.0|20.5|||t-test, 2 sided|||Null hypothesis of no difference between arms at week 26 (DTG+FTC/TAF - EFV/FTC/TDF).||20.5|-21.0|0.98
70973036|NCT03048422|141453009|SUPERIORITY||Risk Difference (RD)|-0.9||||0.4|TWO_SIDED|95.0|-3.1|1.3|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TAF - DTG+FTC/TDF).||1.3|-3.1|0.40
70973037|NCT03048422|141453009|SUPERIORITY||Risk Difference (RD)|-4.3||||0.023|TWO_SIDED|95.0|-8.0|-0.6|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TDF - EFV/FTC/TDF).||-0.6|-8.0|0.023
70973038|NCT03048422|141453009|SUPERIORITY||Risk Difference (RD)|-5.2||||0.003|TWO_SIDED|95.0|-8.7|-1.8|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TAF - EFV/FTC/TDF).||-1.8|-8.7|0.003
70973039|NCT03048422|141453011|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|-3.6||||0.16|TWO_SIDED|95.0|-8.8|1.5|||Wald test of two proportions|||||1.5|-8.8|0.16
70973040|NCT03048422|141453011|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|-2.7||||0.38|TWO_SIDED|95.0|-8.7|3.3|||Wald test of two proportions|||||3.3|-8.7|0.38
70973041|NCT03048422|141453011|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|-6.3||||0.023|TWO_SIDED|95.0|-11.8|-0.9|||Wald test of two proportions|||||-0.9|-11.8|0.023
70973042|NCT03048422|141453012|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|-6.2||||0.12|TWO_SIDED|95.0|-13.9|1.5|||Wald test of two proportions|||||1.5|-13.9|0.12
70973043|NCT03048422|141453012|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|2.0||||0.63|TWO_SIDED|95.0|-6.0|10.0|||Wald test of two proportions|||||10.0|-6.0|0.63
70973044|NCT03048422|141453012|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|-4.2||||0.28|TWO_SIDED|95.0|-11.7|3.4|||Wald test of two proportions|||||3.4|-11.7|0.28
70973045|NCT03048422|141453013|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.011|TWO_SIDED|95.0|0.013|0.103|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TAF - DTG+FTC/TDF).||0.103|0.013|0.011
71032218|NCT03450057|141573197|OTHER|The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.|||||||||||||||||The PFS function was estimated using the Kaplan-Meier product-limit method. Median and one-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.|||
70920244|NCT01780298|141330956|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.474||||0.0002|TWO_SIDED|95.0|-11.207|-3.741|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||-3.741|-11.207|0.0002
70920245|NCT01780298|141330956|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.013|||<|0.0001|TWO_SIDED|95.0|-15.979|-6.046|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||-6.046|-15.979|<0.0001
70920246|NCT01780298|141330957|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-27.611|||<|0.0001|TWO_SIDED|95.0|-32.249|-22.973|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||-22.973|-32.249|<0.0001
70920247|NCT01780298|141330957|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-24.553|||<|0.0001|TWO_SIDED|95.0|-29.501|-19.604|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||-19.604|-29.501|<0.0001
70920248|NCT01780298|141330957|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.107|||<|0.0001|TWO_SIDED|95.0|-19.043|-9.17|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||-9.170|-19.043|<0.0001
70920249|NCT01780298|141330957|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.058||||0.0983|TWO_SIDED|95.0|-6.702|0.585|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||0.585|-6.702|0.0983
70920250|NCT01780298|141330957|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.446|||<|0.0001|TWO_SIDED|95.0|-13.845|-7.047|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||-7.047|-13.845|<0.0001
70920251|NCT01780298|141330957|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.504|||<|0.0001|TWO_SIDED|95.0|-17.302|-9.707|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||-9.707|-17.302|<0.0001
70920252|NCT01780298|141330958|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|40.448|||<|0.0001|TWO_SIDED|95.0|28.374|52.521|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||52.521|28.374|<0.0001
70920253|NCT01780298|141330958|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|26.538|||<|0.0001|TWO_SIDED|95.0|14.89|38.185|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||38.185|14.890|<0.0001
70920254|NCT01780298|141330958|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|20.661||||0.0018|TWO_SIDED|95.0|7.997|33.324|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||33.324|7.997|0.0018
70920255|NCT01780298|141330958|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.91||||0.0015|TWO_SIDED|95.0|5.534|22.286|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||22.286|5.534|0.0015
70920256|NCT01780298|141330958|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.877||||0.1847|TWO_SIDED|95.0|-2.886|14.639|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||14.639|-2.886|0.1847
70920257|NCT01780298|141330958|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.787||||0.0003|TWO_SIDED|95.0|9.536|30.038|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||30.038|9.536|0.0003
70920258|NCT01780298|141330959|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2979.725||||0.1981|TWO_SIDED|95.0|-7560.258|1600.808|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||1600.808|-7560.258|0.1981
70920259|NCT01780298|141330959|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2317.131||||0.1956|TWO_SIDED|95.0|-1224.786|5859.048|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||5859.048|-1224.786|0.1956
70920260|NCT01780298|141330959|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2396.589||||0.2077|TWO_SIDED|95.0|-1367.692|6160.87|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||6160.870|-1367.692|0.2077
70920261|NCT01780298|141330959|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5296.856||||0.1154|TWO_SIDED|95.0|-11930.19|1336.478|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||1336.478|-11930.190|0.1154
70973046|NCT03048422|141453013|SUPERIORITY||Mean Difference (Final Values)|0.028||||0.19|TWO_SIDED|95.0|-0.014|0.07|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TDF - EFV/FTC/TDF).||0.070|-0.014|0.19
70973047|NCT03048422|141453013|SUPERIORITY||Mean Difference (Final Values)|0.086|||<|0.001|TWO_SIDED|95.0|0.04|0.133|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TAF - EFV/FTC/TDF).||0.133|0.040|< 0.001
70973048|NCT03048422|141453014|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.11|TWO_SIDED|95.0|-0.005|0.048|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TAF - DTG+FTC/TDF).||0.048|-0.005|0.11
70973049|NCT03048422|141453014|SUPERIORITY||Mean Difference (Final Values)|0.024||||0.055|TWO_SIDED|95.0|0.0|0.049|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TDF - EFV/FTC/TDF).||0.049|-0.000|0.055
70973050|NCT03048422|141453014|SUPERIORITY||Mean Difference (Final Values)|0.046|||<|0.001|TWO_SIDED|95.0|0.022|0.07|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TAF - EFV/FTC/TDF).||0.070|0.022|< 0.001
71094575|NCT00221104|141697023|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.3075|TWO_SIDED|95.0|0.81|1.91|||Stratified log-rank test|log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)||1.91|0.81|0.3075
70920262|NCT01780298|141330959|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-79.458||||0.8095|TWO_SIDED|95.0|-736.151|577.234|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||577.234|-736.151|0.8095
70920263|NCT01780298|141330959|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5376.314||||0.1113|TWO_SIDED|95.0|-12030.714|1278.085|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||1278.085|-12030.714|0.1113
70973051|NCT03048422|141453015|SUPERIORITY||Mean Difference (Final Values)|0.023||||0.041|TWO_SIDED|95.0|0.001|0.045|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TAF - DTG+FTC/TDF).||0.045|0.001|0.041
70973052|NCT03048422|141453015|SUPERIORITY||Mean Difference (Final Values)|0.034||||0.002|TWO_SIDED|95.0|0.013|0.055|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TDF - EFV/FTC/TDF).||0.055|0.013|0.002
71032219|NCT03450057|141573198|OTHER|The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.|||||||||||||||||The PFS function was estimated using the Kaplan-Meier product-limit method. Median and one-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.|||
71032220|NCT03450057|141573199|OTHER|The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.|||||||||||||||||The PFS function was estimated using the Kaplan-Meier product-limit method. Median and one-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.|||
71032221|NCT02246166|141573247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.9473|TWO_SIDED|95.0|-0.77|0.83|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate|Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatment|||0.83|-0.77|0.9473
71032222|NCT02246166|141573248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.721|TWO_SIDED|95.0|-1.23|0.86|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.|Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatme|||0.86|-1.23|0.7210
71032223|NCT02246166|141573249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.7445|TWO_SIDED|95.0|-1.07|1.49|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.||||1.49|-1.07|0.7445
71032224|NCT02246166|141573250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.7662|TWO_SIDED|95.0|-1.32|1.78|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate||||1.78|-1.32|0.7662
71032225|NCT02246166|141573251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56||||0.5208|TWO_SIDED|95.0|-1.18|2.29|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.|Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatment|||2.29|-1.18|0.5208
71032226|NCT02246166|141573252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.8993|TWO_SIDED|95.0|-1.71|1.94|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.|Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatment|||1.94|-1.71|0.8993
71032227|NCT00377260|141573286|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of clinical treatment failures by the on-therapy visit.||||< .001
71032228|NCT00377260|141573287|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of clinical failures by the end of therapy.||||< .001
70973053|NCT03048422|141453015|SUPERIORITY||Mean Difference (Final Values)|0.057|||<|0.001|TWO_SIDED|95.0|0.036|0.078|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TAF - EFV/FTC/TDF).||0.078|0.036|< 0.001
70973054|NCT01564862|141453019|SUPERIORITY_OR_OTHER||LS mean difference|1.75|STANDARD_ERROR_OF_MEAN|0.744||0.019|TWO_SIDED|95.0|0.28|3.21||P-value was from an ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.|ANCOVA|||||3.21|0.28|0.019
71094576|NCT00221104|141697024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.36||||0.1986|TWO_SIDED|95.0|0.61|9.14|||Stratified log-rank test|log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)||9.14|0.61|0.1986
71094577|NCT00221104|141697025|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9953|TWO_SIDED|95.0|0.45|2.22|||Stratified log-rank test|log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)||2.22|0.45|0.9953
71094578|NCT03301714|141697026|EQUIVALENCE|equivalence analysis|Mean Difference (Final Values)|7.62||||0|TWO_SIDED|95.0||||baseline demographics, correlated errors due to repeated measures, and bias due to lost to follow-up were accounted for via Generalized Estimating Equation (statistical threshold \<0.01)|Regression, Linear||Mean change difference in oral health related quality of life among control, intervention 1: group-based oral health education and intervention 2: individual-based oral health education using motivational interviewing.|||||.000
70920264|NCT01780298|141330960|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.015|||<|0.0001|TWO_SIDED|95.0|4.51|7.521|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||7.521|4.510|<0.0001
70920265|NCT01780298|141330960|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.845|||<|0.0001|TWO_SIDED|95.0|3.379|6.31|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||6.310|3.379|<0.0001
70920266|NCT01780298|141330960|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.454|||<|0.0001|TWO_SIDED|95.0|1.923|4.984|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||4.984|1.923|<0.0001
70920267|NCT01780298|141330960|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.171||||0.0418|TWO_SIDED|95.0|0.045|2.296|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||2.296|0.045|0.0418
70920268|NCT01780298|141330960|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.391||||0.0357|TWO_SIDED|95.0|0.096|2.686|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||2.686|0.096|0.0357
70920269|NCT01780298|141330960|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.562||||0.0001|TWO_SIDED|95.0|1.303|3.82|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||3.820|1.303|0.0001
70920270|NCT01780298|141330961|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|39.633|||<|0.0001|TWO_SIDED|95.0|33.964|45.302|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||45.302|33.964|<0.0001
70920271|NCT01780298|141330961|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|35.792|||<|0.0001|TWO_SIDED|95.0|29.761|41.822|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||41.822|29.761|<0.0001
70920272|NCT01780298|141330961|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29.167|||<|0.0001|TWO_SIDED|95.0|23.445|34.888|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||34.888|23.445|<0.0001
70920273|NCT01780298|141330961|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.842||||0.0418|TWO_SIDED|95.0|0.147|7.536|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||7.536|0.147|0.0418
70920274|NCT01780298|141330961|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.625||||0.0084|TWO_SIDED|95.0|1.763|11.487|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||11.487|1.763|0.0084
70920275|NCT01780298|141330961|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.467|||<|0.0001|TWO_SIDED|95.0|5.888|15.045|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||15.045|5.888|<0.0001
70920276|NCT01780298|141330962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.929|||<|0.0001|TWO_SIDED|95.0|0.654|1.203|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||1.203|0.654|<0.0001
70920277|NCT01780298|141330962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.875|||<|0.0001|TWO_SIDED|95.0|0.609|1.141|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||1.141|0.609|<0.0001
70920278|NCT01780298|141330962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.649|||<|0.0001|TWO_SIDED|95.0|0.386|0.912|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||0.912|0.386|<0.0001
71094579|NCT02906618|141697105|OTHER|A mixed-effect analysis of variance model was applied to the log-transformed dose-adjusted AUC(0-∞) of LY3039478 after oral dosing and IV administration of 13C 15N 2H-LY3039478. The model contained a fixed effect for formulation (oral or IV) and a random effect for participant.|Ratio of geometric LS means|0.572|||||TWO_SIDED|90.0|0.532|0.615||||||||0.615|0.532|
71094580|NCT00143507|141697112|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.945|TWO_SIDED|95.0|0.91|1.1|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.10|0.91|0.945
71094581|NCT00143507|141697113|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.316|TWO_SIDED|95.0|0.94|1.22|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.22|0.94|0.316
71094582|NCT00143507|141697114|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.159|TWO_SIDED|95.0|0.72|1.06|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.06|0.72|0.159
71094583|NCT00143507|141697115|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.85|TWO_SIDED|95.0|0.86|1.13|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.13|0.86|0.850
70920279|NCT01780298|141330962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.069||||0.3985|TWO_SIDED|95.0|-0.093|0.231|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||0.231|-0.093|0.3985
70920280|NCT01780298|141330962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22||||0.0267|TWO_SIDED|95.0|0.026|0.414|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||0.414|0.026|0.0267
70920281|NCT01780298|141330962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.305||||0.0036|TWO_SIDED|95.0|0.104|0.506|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||0.506|0.104|0.0036
70920282|NCT01780298|141330963|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.564|||<|0.0001|TWO_SIDED|95.0|1.179|1.949|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||1.949|1.179|<0.0001
70920283|NCT01780298|141330963|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.291|||<|0.0001|TWO_SIDED|95.0|0.924|1.658|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||1.658|0.924|<0.0001
70920284|NCT01780298|141330963|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.073|||<|0.0001|TWO_SIDED|95.0|0.724|1.421|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||1.421|0.724|<0.0001
70973055|NCT01564862|141453019|SUPERIORITY_OR_OTHER||LS mean difference|1.21|STANDARD_ERROR_OF_MEAN|0.733||0.099|TWO_SIDED|95.0|-0.23|2.65||P-value was from an ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.|ANCOVA|||||2.65|-0.23|0.099
70973056|NCT01564862|141453019|SUPERIORITY_OR_OTHER||LS mean difference|0.54|STANDARD_ERROR_OF_MEAN|0.725||0.46|TWO_SIDED|95.0|-0.89|1.96||P-value was from an ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.|ANCOVA|||||1.96|-0.89|0.460
70973057|NCT01564862|141453020|SUPERIORITY_OR_OTHER||LS Mean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.78||0.001|TWO_SIDED|95.0|-4.1|-1.0||P-value was from a MMRM model with baseline\*week, center, week, treatment and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||-1.0|-4.1|0.001
70973058|NCT01564862|141453020|SUPERIORITY_OR_OTHER||LS mean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.77|<|0.001|TWO_SIDED|95.0|-4.5|-1.5||P-value was from a MMRM model with baseline\*week, center, week, treatment and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||-1.5|-4.5|<0.001
70973059|NCT01564862|141453021|SUPERIORITY_OR_OTHER||LS Mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.1211||0.017|TWO_SIDED|95.0|-0.528|-0.052||P-value was from a MMRM model with baseline\*week, center, week, treatment and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||-0.052|-0.528|0.017
70973060|NCT01564862|141453021|SUPERIORITY_OR_OTHER||LS mean difference|-0.404|STANDARD_ERROR_OF_MEAN|0.1194|<|0.001|TWO_SIDED|95.0|-0.638|-0.169||P-value was from a MMRM model with baseline\*week, center, week, treatment and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||-0.169|-0.638|<0.001
70973061|NCT04526665|141453034|OTHER||Odds Ratio (OR)|37.562|||<|0.0001|TWO_SIDED|95.0|7.641|302.247|||Exact Cochran-Mantel-Haenszel test|Exact Cochran-Mantel-Haenszel test stratified by the randomization factors (ALP \>3xULN or TB\>ULN:Yes/No, and Baseline PBC Worst Itch NRS ≥ 4: Yes/No)||||302.247|7.641|<0.0001
70973062|NCT04526665|141453036|OTHER||Least square mean difference|-0.784||||0.197|TWO_SIDED|95.0|-1.986|0.418|||mixed model for repeated measures (MMRM)|||||0.418|-1.986|0.1970
70973063|NCT04526665|141453037|OTHER||Least square mean difference|-0.343||||0.5522|TWO_SIDED|95.0|-1.489|0.803|||MMRM|MMRM with treatment, 4-week period and treatment by 4-week period interaction as fixed factors and adjusting for baseline and stratification factors.||||0.803|-1.489|0.5522
70973064|NCT01844986|141453081|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.23|0.41||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.41|0.23|<0.0001
70973065|NCT01844986|141453081|SUPERIORITY||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.23|0.97||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \< 1 favours olaparib|||0.97|0.23|
70973066|NCT01844986|141453082|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.8903|TWO_SIDED|95.0|0.6|1.53||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||1.53|0.60|0.8903
70973067|NCT01844986|141453082|SUPERIORITY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.29|2.28||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \< 1 favours olaparib|||2.28|0.29|
70973068|NCT01844986|141453083|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.23|0.4||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.40|0.23|<0.0001
70973069|NCT01844986|141453083|SUPERIORITY||Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.23|0.99||Not applicable due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \<1 favours Olaparib.|||0.99|0.23|
70973070|NCT01844986|141453084|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.0002|TWO_SIDED|95.0|0.35|0.72||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.72|0.35|0.0002
70973071|NCT01844986|141453084|SUPERIORITY||Hazard Ratio (HR)|0.55|||||TWO_SIDED|95.0|0.23|1.35||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \<1 favours Olaparib.|||1.35|0.23|
70973072|NCT01844986|141453085|SUPERIORITY||Mean Difference (Final Values)|-3.0||||0.001|TWO_SIDED|95.0|-4.779|-1.216|||Mixed Models Analysis|Fixed effects for treatment, visit and baseline TOI with the treatment by visit and baseline TOI by visit interaction. Random patient effect.||||-1.216|-4.779|0.0010
70973073|NCT01844986|141453086|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.22|0.4||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.40|0.22|<0.0001
70973074|NCT01844986|141453086|SUPERIORITY||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.29|1.23||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \<1 favours Olaparib.|||1.23|0.29|
70973075|NCT01844986|141453087|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.32|0.63||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.63|0.32|<0.0001
70973076|NCT01844986|141453087|SUPERIORITY||Hazard Ratio (HR)|0.55|||||TWO_SIDED|95.0|0.25|1.26||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \<1 favours Olaparib.|||1.26|0.25|
70973077|NCT01844986|141453088|SUPERIORITY||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.51|0.79||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.79|0.51|<0.0001
70973078|NCT01844986|141453088|SUPERIORITY||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.47|1.42||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \<1 favours Olaparib.|||1.42|0.47|
70973079|NCT01844986|141453089|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.22|0.4||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.40|0.22|<0.0001
71094584|NCT00143507|141697116|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.547|TWO_SIDED|95.0|0.92|1.16|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.16|0.92|0.547
70973080|NCT01790503|141453103|OTHER||Hazard Ratio (HR)|0.98||||0.456|TWO_SIDED|95.0|0.71|1.36|||Log Rank|||||1.36|0.71|0.456
70973081|NCT01790503|141453103|OTHER||Hazard Ratio (HR)|1.05||||0.619|TWO_SIDED|95.0|0.77|1.43|||Log Rank|||||1.43|0.77|0.619
70973082|NCT01790503|141453103|OTHER||Hazard Ratio (HR)|0.9||||0.272|TWO_SIDED|95.0|0.65|1.26|||Log Rank|||||1.26|0.65|0.272
70973083|NCT01790503|141453104|OTHER|||||||0.44|||||||t-test, 2 sided|||Comparison between age subgroups: 18-64 years vs 65+ years||||0.440
70973084|NCT01790503|141453104|OTHER|||||||0.699|||||||t-test, 2 sided|||Comparison between extent of surgery subgroups: complete resection vs partial resection||||0.699
70973085|NCT01790503|141453104|OTHER|||||||0.003|||||||t-test, 2 sided|||Comparison between baseline KPS subgroups: 70-89 vs 90-100||||0.003
70973086|NCT01790503|141453104|OTHER|||||||0.201|||||||t-test, 2 sided|||Comparison between MGMT status subgroups: methylated vs unmethylated||||0.201
70973087|NCT01790503|141453106|OTHER||Hazard Ratio (HR)|0.94||||0.389|TWO_SIDED|95.0|0.6|1.47|||Log Rank|||||1.47|0.60|0.389
70973088|NCT01790503|141453106|OTHER||Hazard Ratio (HR)|0.94||||0.393|TWO_SIDED|95.0|0.63|1.42|||Log Rank|||||1.42|0.63|0.393
70973089|NCT01790503|141453106|OTHER||Hazard Ratio (HR)|0.98||||0.469|TWO_SIDED|95.0|0.63|1.54|||Log Rank|||||1.54|0.63|0.469
70973090|NCT01790503|141453107|OTHER|||||||0.063|||||||t-test, 2 sided|||Comparison between age subgroups: 18-64 years vs 65+ years||||0.063
70973091|NCT01790503|141453107|OTHER|||||||0.969|||||||t-test, 2 sided|||Comparison between extent of surgery subgroups: complete resection vs partial resection||||0.969
70973092|NCT01790503|141453107|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison between baseline KPS subgroups: 70-89 vs 90-100||||<0.001
71094585|NCT00143507|141697117|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.331|TWO_SIDED|95.0|0.71|1.12|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.12|0.71|0.331
71094586|NCT00143507|141697118|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.078|TWO_SIDED|95.0|0.67|1.02|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.02|0.67|0.078
70920285|NCT01780298|141330963|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.276||||0.0282|TWO_SIDED|95.0|0.031|0.521|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||0.521|0.031|0.0282
70920286|NCT01780298|141330963|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.207||||0.1223|TWO_SIDED|95.0|-0.057|0.471|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||0.471|-0.057|0.1223
70920287|NCT01780298|141330963|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.492|||<|0.0001|TWO_SIDED|95.0|0.273|0.71|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||0.710|0.273|<0.0001
70920288|NCT01780298|141330964|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.372|||<|0.0001|TWO_SIDED|95.0|0.269|0.478|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||0.478|0.269|<0.0001
70920289|NCT01780298|141330964|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.256|||<|0.0001|TWO_SIDED|95.0|0.158|0.354|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||0.354|0.158|<0.0001
70920290|NCT01780298|141330964|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.136||||0.0199|TWO_SIDED|95.0|0.022|0.249|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||0.249|0.022|0.0199
70920291|NCT01780298|141330964|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.117||||0.0247|TWO_SIDED|95.0|0.015|0.218|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||0.218|0.015|0.0247
70920292|NCT01780298|141330964|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12||||0.0204|TWO_SIDED|95.0|0.019|0.221|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||0.221|0.019|0.0204
70920293|NCT01780298|141330964|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.237|||<|0.0001|TWO_SIDED|95.0|0.127|0.347|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||0.347|0.127|<0.0001
70920294|NCT05286385|141331001|NON_INFERIORITY|Non-inferiority margin -10%|Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|4.59|||TWO_SIDED|95.0|-6.29|0.29||||||||0.29|-6.29|
70920295|NCT05286385|141331002|NON_INFERIORITY|Non-inferiority margin -10%|Mean Difference (Final Values)|-2.3|STANDARD_DEVIATION|8.03|||TWO_SIDED|95.0|-8.04|3.44||||||||3.44|-8.04|
70920296|NCT05286385|141331003|NON_INFERIORITY|Non-inferiority margin -10%|Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|4.55|||TWO_SIDED|95.0|-2.95|3.55||||||||3.55|-2.95|
70920297|NCT01534494|141331035|OTHER|Paired t-test||||||0.008|||||||t-test, 2 sided|Paired t-test for significance of change. t(8) = 3.477. P(2-sided) = 0.008||Single-group pre-post contrast||||0.008
70920298|NCT01643616|141331081|SUPERIORITY_OR_OTHER||Percentage Difference|33.0|||<|0.05|||||||Fisher Exact||For success rate without supplementation the difference between group US (94.9%) and group NS (61.9%) is 33%.|For sample size calculation we assumed a significance level of 0.05 and a success rate derived from clinical data of 75% in the nerve stimulation group and of 90% in the ultrasound group. With a group ratio of 1:1 and a power of 0.8, the required sample size was at least 226. For statistical analysis we used the exact Fisher test as a distribution-free, non-parametric test method.||||< 0.05
70920299|NCT01643616|141331082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.9|||<|0.05|TWO_SIDED|95.0|13.6|31.1|||Log Rank|||We used the log-rank test to compare the onset times. The significance level was defined with p\<0.05.||31.1|13.6|< 0.05
70920300|NCT01643616|141331083|SUPERIORITY_OR_OTHER||Percentage Difference|26.2||||0.05|||||||Fisher Exact||For success rate with supplementation the difference between group US (98.2%) and group NS (72%) is 26.2%.|For sample size calculation we assumed a significance level of 0.05 and a success rate derived from clinical data of 75% in the nerve stimulation group and of 90% in the ultrasound group. With a group ratio of 1:1 and a power of 0.8, the required sample size was at least 226. For statistical analysis we used the exact Fisher test as a distribution-free, non-parametric test method.||||0.05
70920301|NCT04425863|141331108|OTHER|||||||0.0246|||||||Chi-squared|||A chi-squared test is used to find out whether there is a statistically significant decrease in mortality rate when the IDEA treatment protocol is used in hospitalized patients in comparison with other treatments in the same hospital in the same period of time (3 out of 12 inpatients died)||||0.0246
70920302|NCT04425863|141331108|OTHER|||||||0.0475|||||||Chi-squared|||Overall mortality rate of patients treated according to IDEA protocol is compared by a chi-squared test against overall mortality rate in Argentina (the same region where the hospital is located). Data used for overall mortality in Argentina correspond to June 30th according to the website of the Ministry of Health of Argentina||||0.0475
70973093|NCT01790503|141453107|OTHER|||||||0.501|||||||t-test, 2 sided|||Comparison between MGMT status subgroups: methylated vs unmethylated||||0.501
70973094|NCT01790503|141453108|OTHER|||||||0.705|||||||t-test, 2 sided|||Comparison between age subgroups: 18-64 years vs 65+ years||||0.705
70973095|NCT01790503|141453108|OTHER||||||>|0.999|||||||t-test, 2 sided|||Comparison between extent of surgery subgroups: complete resection vs partial resection||||>0.999
71094587|NCT00143507|141697119|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.583|TWO_SIDED|95.0|0.83|1.4|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.40|0.83|0.583
70920303|NCT04425863|141331108|OTHER|||||||0.0025|||||||Chi-squared|||A chi-square test was applied to compare the mortality rate of patients treated with IDEA protocol as compared with data published (26.84 %) in Bertsimas D, Lukin G, Mingardi L, Nohadani O, Orfanoudaki A, Stellato B et al. (2020), COVID-19 Mortality Risk Assessment: An International Multi-Center Study doi: 10.1101/2020.07.07.20148304||||0.0025
70920304|NCT01854385|141331116|SUPERIORITY|||||||0.079|||||||Mixed Models Analysis|||||||.079
70920305|NCT02597920|141331145|OTHER||||||<|0.0001|||||||Paired t-test|||Within group comparison of Baseline CDS with that of Visit 2.||||<0.0001
70920306|NCT02597920|141331145|OTHER||||||<|0.0001|||||||Paired t-test|||Within group comparison of Baseline CDS with that of Visit 3.||||<0.0001
70920307|NCT02597920|141331145|OTHER||||||<|0.0001|||||||Paired t-test|||Within group comparison of Baseline SDS with that of Visit 2.||||<0.0001
70920308|NCT02597920|141331145|OTHER||||||<|0.0001|||||||Paired t-test|||Within group comparison of Baseline SDS with that of Visit 3.||||<0.0001
70920309|NCT02597920|141331146|OTHER|||||||0.0005|||||||Propensity score matching method|||Between group comparison of Visit 2 CDS||||0.0005
70920310|NCT02597920|141331146|OTHER|||||||0.0002|||||||Propensity score matching method|||Between group comparison of Visit 3 CDS||||0.0002
70920311|NCT02597920|141331146|OTHER|||||||0.0002|||||||Propensity score matching method|||Between group comparison of Visit 2 SDS||||0.0002
70920312|NCT02597920|141331146|OTHER|||||||0.0004|||||||Propensity score matching method|||Between group comparison of Visit 3 SDS||||0.0004
70920313|NCT02597920|141331151|OTHER||||||<|0.0001|||||||Paired t-test|||Within group comparison of Visit 2 CDS with that of Visit 3.||||<0.0001
70920314|NCT02597920|141331151|OTHER||||||<|0.0001|||||||Paired t-test|||Within group comparison of Visit 2 SDS with that of Visit 3.||||<0.0001
70920315|NCT04040296|141331160|SUPERIORITY||Difference in percentage|1.4||||0.28|TWO_SIDED|95.0|-1.1|3.8|||Cochran-Mantel-Haenszel||Difference between arms in the percentage of subjects with the primary outcome within 14 days of randomization.|||3.8|-1.1|0.28
70920316|NCT04040296|141331161|SUPERIORITY||Difference in percentage|9.5|||<|0.001|TWO_SIDED|95.0|8.1|11.0|||Van Elteren test||Difference between arms in the percentage of implemented recommendations with 24 hours of randomization.|Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.||11|8.1|<.001
70920317|NCT04040296|141331162|SUPERIORITY||Difference in percentage|0.5||||0.65|TWO_SIDED|95.0|-1.6|2.6|||Van Elteren test||Difference between arms in the percentage of subjects with AKI progression within 14 days of randomization.|Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.||2.6|-1.6|.65
70920318|NCT04040296|141331163|SUPERIORITY||Difference in percentage|0.1||||0.89|TWO_SIDED|95.0|-0.7|0.8|||Van Elteren test||Difference between arms in the percentage of subjects who received inpatient dialysis within 14 days of randomization.|Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.||.8|-.7|.89
70920319|NCT04040296|141331164|SUPERIORITY||Difference in percentage|0.4||||0.72|TWO_SIDED|95.0|-1.5|2.1|||Van Elteren test||Difference between arms in the percentage of subjects with inpatient mortality within 14 days of randomization.|Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.||2.1|-1.5|.72
70920320|NCT04040296|141331165|SUPERIORITY||Difference in percentage|1.9||||0.31|TWO_SIDED|95.0|-0.3|4.1|||Van Elteren test||Difference between arms in the percentage of subjects who received a kidney consult within 14 days of randomization.|Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.||4.1|-.3|.31
70920321|NCT04040296|141331166|SUPERIORITY||Difference in percentage|-0.9||||0.17|TWO_SIDED|95.0|-2.3|0.4|||Van Elteren test||Difference between arms in the percentage of subjects discharged to hospice care within 14 days of randomization.|Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.||.4|-2.3|.17
70920322|NCT05489484|141331167|OTHER|Paired-sample t-test was used to assess the change in Constant-Murley Score from baseline to 3 months.|Mean Difference (Net)|10.03|STANDARD_ERROR_OF_MEAN|2.124||0.001|TWO_SIDED|95.0|3.63|16.0|||t-test, 2 sided||Mean change from baseline in CMS at 3 months. Higher scores represent better shoulder function. Positive difference indicates clinical improvement.|Statistical analysis was performed on 23 participants with valid Constant-Murley Score (CMS) data at both baseline and 3-month follow-up.||16.00|3.63|0.001
70920323|NCT00444600|141331179|SUPERIORITY_OR_OTHER_LEGACY||Difference in mean change|-55.0|||<|0.001|TWO_SIDED|95.0|-78.0|-32.0||Confidence intervals are adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline retinal thickness and visual acuity and correlation between two study eyes.||Difference in central subfield thickness mean change from sham+prompt laser||-32|-78|<0.001
70920324|NCT00444600|141331179|SUPERIORITY_OR_OTHER_LEGACY||Difference in mean change|-49.0|||<|0.001|TWO_SIDED|95.0|-72.0|-26.0||Confidence intervals are adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline retinal thickness and visual acuity and correlation between two study eyes.||Difference in optical coherence tomography central subfield thickness mean change from sham+prompt laser||-26|-72|<0.001
70973096|NCT01790503|141453108|OTHER|||||||0.099|||||||t-test, 2 sided|||Comparison between baseline KPS subgroups: 70-89 vs 90-100||||0.099
70973097|NCT01790503|141453108|OTHER|||||||0.348|||||||t-test, 2 sided|||Comparison between MGMT status subgroups: methylated vs unmethylated||||0.348
70973098|NCT03269344|141453129|SUPERIORITY|||||||0.11|||||||ANOVA|||||||0.11
70973099|NCT03269344|141453130|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
70973100|NCT03269344|141453131|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
70973101|NCT03269344|141453132|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
70973102|NCT03269344|141453133|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||||||0.81
70973103|NCT03269344|141453134|SUPERIORITY||||||<|0.01|||||||Chi-squared|||||||<0.01
70973104|NCT02597855|141453135|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher Exact|||The difference of polyp regression rate between two groups were compared.||||<0.05
71032229|NCT00377260|141573288|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the symptom burden as measured by the respective mean scores over time.||||.02
71032230|NCT00377260|141573289|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of children who develop worsening symptoms within the first 3 days of treatment.||||.24
71032231|NCT00377260|141573290|SUPERIORITY_OR_OTHER|||||||0.35||95.0||||A weighted regression model was used with weights equal to the number of days information regarding analgesic use was reported by the parents.|Regression, Linear|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the average number of doses of analgesic medication administered by parents.||||.35
71032232|NCT00377260|141573291|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with protocol-defined diarrhea.||||.04
71032233|NCT00377260|141573291|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with diaper dermatitis.||||<.01
71032234|NCT00377260|141573291|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with oral thrush.||||.07
71094588|NCT00143507|141697120|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.501|TWO_SIDED|95.0|0.81|1.11|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.11|0.81|0.501
70973105|NCT02597855|141453136|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|The Mann-Whitney test was used for a comparison of best corrected visual acuity assessed at baseline, 3 months, and 6 months between type1 and type2.||best corrected visual acuity was compared between two groups||||<0.05
70973106|NCT01449708|141453137|SUPERIORITY_OR_OTHER||Relative Risk|1.27||||0.04|TWO_SIDED|95.0|1.01|1.61|||Chi-squared|||||1.61|1.01|0.04
71032235|NCT00377260|141573291|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with vomiting.||||>.99
71032236|NCT00377260|141573291|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with rash.||||>.99
71032237|NCT00377260|141573291|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with mastoiditis.||||.99
71032238|NCT00377260|141573291|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with perforation of their tympanic membrane.||||.08
71032239|NCT00377260|141573292|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with at least one AOM pathogen present.||||.002
71032240|NCT00377260|141573292|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Streptococcus pneumoniae present.||||<.001
71032241|NCT00377260|141573292|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Haemophilus influenzae present.||||.85
71032242|NCT00377260|141573292|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Moraxella catarrhalis present.||||<.001
71094589|NCT00143507|141697121|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.141|TWO_SIDED|95.0|0.78|1.04|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.04|0.78|0.141
71094590|NCT00143507|141697122|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.411|TWO_SIDED|95.0|0.86|1.06|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.06|0.86|0.411
71094591|NCT00143507|141697123|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.484|TWO_SIDED|95.0|0.94|1.15|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.15|0.94|0.484
70973107|NCT01449708|141453139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.04||||0.009|TWO_SIDED|95.0|1.28|7.29|||Chi-squared|||Grouping of surgical procedures into three categories, analysis using bonferroni correction, 1) ReY group( gastric bypass, conversion to gastric bypass and revision gastric bypass) 2) Gastric Band (GB), 3) sleeve gastrectomy (SG)||7.29|1.28|0.009
71032243|NCT00377260|141573292|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Streptococcus pyogenes present.||||.28
71032244|NCT00377260|141573293|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of children colonized with penicillin-susceptible Streptococcus pneumoniae.||||< .001
71032245|NCT00377260|141573294|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with at least one AOM pathogen present.||||.10
71032246|NCT00377260|141573294|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Streptococcus pneumoniae present.||||.03
71032247|NCT00377260|141573294|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Haemophilus influenzae present.||||.96
71032248|NCT00377260|141573294|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Moraxella catarrhalis present.||||.79
71032249|NCT00377260|141573294|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Streptococcus pyogenes present.||||.98
71032250|NCT00377260|141573295|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of children colonized with penicillin-susceptible Streptococcus pneumoniae.||||.04
71032251|NCT00377260|141573296|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the probability of middle ear effusion at the on-therapy visit.||||.03
71032252|NCT00377260|141573297|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the probability of middle ear effusion at the end-of-therapy visit.||||.006
71032253|NCT00377260|141573298|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||The analysis was ITT. The number of participants equals the number of children for which at least one ear has an interpretable tympanogram at the follow-up visit.||||.04
71032254|NCT00377260|141573299|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding visits to primary care provider.||||.20
71032255|NCT00377260|141573300|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding visits to emergency room||||.90
71032256|NCT00377260|141573301|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22||||0.14||95.0|||||Regression, Cox|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.|The Amoxicillin-Clavulanate arm represents the numerator and the Placebo arm represents the denominator.|Null hypothesis: There is no difference between the two groups regarding the time to resolution of symptoms where resolution is defined as AOM-SOS score \<=1.||||.14
71032257|NCT00377260|141573302|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.37||||0.04||95.0|||||Regression, Cox|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.|The Amoxicillin-Clavulanate arm represents the numerator and the Placebo arm represents the denominator.|Null hypothesis: There is no difference between the two groups regarding the time to resolution of symptoms where resolution is defined as AOM-SOS score \<=1 on two consecutive occasions.||||.04
71032258|NCT00377260|141573303|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Generalized estimating equations|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the number of antibiotic prescriptions, exclusive of the blinded study medication.||||<.001
71032259|NCT00377260|141573304|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the visits at which family member reported missing work, i.e. number of such visits / total number of follow-up assessment visits.||||.93
71032260|NCT00377260|141573305|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the visits at which family member reported making special daycare arrangements, i.e. number of such visits / total number of follow-up assessment visits.||||.66
71032261|NCT00377260|141573306|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Regression, Linear|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the groups regarding the mean parental satisfaction score at the on-therapy visit.||||.71
71032262|NCT00377260|141573307|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Regression, Linear|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the groups regarding the mean parental satisfaction score at the end-of-therapy visit.||||.04
71032263|NCT00377260|141573308|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Regression, Linear|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the groups regarding the mean parental satisfaction score at the follow-visit visit.||||.005
71032264|NCT00377260|141573309|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Regression, Linear|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the mean weighted average acute otitis media - severity of symptom (AOM-SOS) score (symptom burden), post-enrollment, over the first 7 days of therapy.||||.01
71032265|NCT00829530|141573310|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|88.87||||||90.0|80.31|98.34|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||98.34|80.31|
71032266|NCT00829530|141573311|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|94.96||||||90.0|89.77|100.45|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.45|89.77|
71032267|NCT00829530|141573312|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|95.24||||||90.0|90.13|100.63|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.63|90.13|
71032268|NCT00829530|141573313|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.85||||||90.0|91.95|106.27|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||106.27|91.95|
71032269|NCT00829530|141573314|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.62||||||90.0|97.8|103.52|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||103.52|97.8|
71032270|NCT00840866|141573315|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|104.0||||||90.0|99.0|109.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||109|99|
71032271|NCT00840866|141573316|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.9||||||90.0|98.6|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101|98.6|
71032272|NCT00840866|141573317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.8||||||90.0|98.5|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101|98.5|
70920325|NCT00444600|141331179|SUPERIORITY_OR_OTHER_LEGACY||Difference in mean change|-52.0|||<|0.001|TWO_SIDED|95.0|-75.0|-29.0||Confidence interval is adjusted for multiple comparisons|ANCOVA|Adjusted for baseline retinal thickness and visual acuity and correlation between two study eyes.||Difference in optical coherence tomography central subfield thickness mean change from sham+prompt laser||-29|-75|<0.001
71032273|NCT04112823|141573318|SUPERIORITY||Risk Ratio (RR)|7.0|||||TWO_SIDED|95.0|-6.0|20.0||||||||20|-6|
71032274|NCT04112823|141573319|SUPERIORITY||Risk Ratio (RR)|4.0|||||TWO_SIDED|95.0|-8.0|16.0||||||||16|-8|
71032275|NCT04112823|141573320|SUPERIORITY||Risk Ratio (RR)|3.0|||||TWO_SIDED|95.0|-8.0|14.0||||||||14|-8|
71032276|NCT04112823|141573322|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-0.3|1.2||||||||1.2|-0.3|
70920326|NCT00444600|141331181|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.8|||<|0.001|TWO_SIDED|95.0|3.2|8.5||Adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline visual acuity and correlation between 2 study eyes.||||8.5|3.2|<0.001
70920327|NCT00444600|141331181|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.0|||<|0.001|TWO_SIDED|95.0|3.4|8.6||Adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline visual acuity and correlation between 2 study eyes.||||8.6|3.4|<0.001
70920328|NCT00444600|141331181|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1||||0.31|TWO_SIDED|95.0|-1.5|3.7||Adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline visual acuity and correlation between 2 study eyes.||||3.7|-1.5|0.31
70920329|NCT00444600|141331182|SUPERIORITY_OR_OTHER_LEGACY||Proportion|23.0|||||TWO_SIDED|95.0|13.0|34.0||Confidence intervals are adjusted for multiple comparisons.|Binomial regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥10 letter improvement for sham+prompt laser at 1 year||34|13|
70920330|NCT00444600|141331182|SUPERIORITY_OR_OTHER_LEGACY||Proportion|19.0|||||TWO_SIDED|95.0|9.0|29.0||Confidence intervals adjusted for multiple comparisons|Binomial regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥10 letter improvement from sham+prompt laser at 1 year||29|9|
70920331|NCT00444600|141331182|SUPERIORITY_OR_OTHER_LEGACY||Proportion|6.0|||||TWO_SIDED|95.0|-4.0|16.0||Confidence intervals adjusted for multiple comparisons|Binomial regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥10 letter improvement from sham+prompt laser at 1 year||16|-4|
71032277|NCT04112823|141573323|SUPERIORITY||Risk Ratio (RR)|4.0|||||TWO_SIDED|95.0|-9.0|18.0||||||||18|-9|
71032278|NCT02678286|141573352|SUPERIORITY|||||||0.0145|||||||t-test, 2 sided|||||||0.0145
70920332|NCT00444600|141331182|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.84|||<|0.001|TWO_SIDED|95.0|1.4|2.42||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥10 letter improvement comparison with sham+prompt laser at 1 year||2.42|1.40|<0.001
70920333|NCT00444600|141331182|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.68|||<|0.001|TWO_SIDED|95.0|1.27|2.21||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥10 letter improvement comparison with sham+prompt laser at 1 year||2.21|1.27|<0.001
70920334|NCT00444600|141331182|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.21||||0.16|TWO_SIDED|95.0|0.88|1.66||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.|Eyes were analyzed.|Relative risk for ≥10 letter improvement comparison with sham+prompt laser at 1 year||1.66|0.88|0.16
70920335|NCT00444600|141331182|SUPERIORITY_OR_OTHER_LEGACY||Proportion|-10.0|||||TWO_SIDED|95.0|-16.0|-5.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥10 letter worsening from sham+prompt laser at 1 year||-5|-16|
70920336|NCT00444600|141331182|SUPERIORITY_OR_OTHER_LEGACY||Proportion|-10.0|||||TWO_SIDED|95.0|-16.0|-4.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥10 letter worsening from sham+prompt laser at 1 year||-4|-16|
70920337|NCT00444600|141331182|SUPERIORITY_OR_OTHER_LEGACY||Proportion|1.0|||||TWO_SIDED|95.0|-7.0|9.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥10 letter worsening from sham+prompt laser at 1 year||9|-7|
70920338|NCT00444600|141331182|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.24|||<|0.001|TWO_SIDED|95.0|0.09|0.65||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥10 letter worsening comparison with sham+prompt laser at 1 year||0.65|0.09|<0.001
70920339|NCT00444600|141331182|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.24||||0.001|TWO_SIDED|95.0|0.08|0.68||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥10 letter worsening comparison with sham+prompt laser at 1 year||0.68|0.08|0.001
70920340|NCT00444600|141331182|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.08||||0.75|TWO_SIDED|95.0|0.62|1.87||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥10 letter worsening comparison with sham+prompt laser at 1 year||1.87|0.62|0.75
70920341|NCT00444600|141331182|SUPERIORITY_OR_OTHER_LEGACY||Proportion|16.0|||||TWO_SIDED|95.0|6.0|26.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between to study eyes.||Difference in proportion with ≥15 letter improvement from sham+prompt laser at 1 year||26|6|
70920342|NCT00444600|141331182|SUPERIORITY_OR_OTHER_LEGACY||Proportion|13.0|||||TWO_SIDED|95.0|4.0|22.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥15 letter improvement from sham+prompt laser at 1 year||22|4|
70920343|NCT00444600|141331182|SUPERIORITY_OR_OTHER_LEGACY||Proportion|6.0|||||TWO_SIDED|95.0|-2.0|15.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥15 letter improvement from sham+prompt laser at 1 year||15|-2|
70920344|NCT00444600|141331182|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.09|||<|0.001|TWO_SIDED|95.0|1.35|3.22|||Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter improvement comparison with sham+prompt laser at 1 year||3.22|1.35|<0.001
70920345|NCT00444600|141331182|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.89|||<|0.001|TWO_SIDED|95.0|1.25|2.87||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter improvement comparison with sham+prompt laser at 1 year||2.87|1.25|<0.001
70920346|NCT00444600|141331182|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.43||||0.07|TWO_SIDED|95.0|0.9|2.29||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter improvement comparison with sham+prompt laser at 1 year||2.29|0.90|0.07
70920347|NCT00444600|141331182|SUPERIORITY_OR_OTHER_LEGACY||Proportion|-6.0|||||TWO_SIDED|95.0|-11.0|-2.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥15 letter worsening from sham+prompt laser at 1 year||-2|-11|
70920348|NCT00444600|141331182|SUPERIORITY_OR_OTHER_LEGACY||Proportion|-6.0|||||TWO_SIDED|95.0|-10.0|-1.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥15 letter worsening from sham+prompt laser at 1 year||-1|-10|
71032279|NCT02678286|141573353|SUPERIORITY|||||||0.1841||||||Row 1 (SPID6)|t-test, 2 sided|||||||0.1841
71094592|NCT00143507|141697124|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.835|TWO_SIDED|95.0|0.9|1.13|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.13|0.90|0.835
71094593|NCT01115231|141697151|OTHER|multivariable logistic regression model|Odds Ratio (OR)|2.03|||||TWO_SIDED|95.0|0.93|4.42||||||||4.42|0.93|
71094594|NCT03928327|141697159|OTHER||Geometric Least Squares (LS) Mean Ratio|2.86|||||TWO_SIDED|90.0|2.48|3.3|||||Linear mixed-effects model was used for analysis, using fixed-effect(treatment), random-effect(participants). Geometric mean ratios(GMR), 90% confidence interval(CI) calculated using exponentiation of treatment least squares means(LSMs) difference.|||3.30|2.48|
71094595|NCT03928327|141697160|OTHER||Geometric LS Mean Ratio|0.08|||||TWO_SIDED|90.0|0.07|0.11|||||Linear mixed-effects model was used for analysis, using fixed-effect (treatment) and random-effect (participants). GMR and 90% CI was calculated using exponentiation of treatment LSMs difference.|||0.11|0.07|
71094596|NCT03928327|141697161|OTHER||Geometric LS Mean Ratio|6.27|||||TWO_SIDED|90.0|5.2|7.56|||||Linear mixed-effects model was used for analysis, using fixed-effect (treatment) and random-effect (participants). GMR and 90% CI was calculated using exponentiation of treatment LSMs difference.|||7.56|5.20|
71094597|NCT03928327|141697162|OTHER||Geometric LS Mean Ratio|0.05|||||TWO_SIDED|90.0|0.04|0.07|||||Linear mixed-effects model was used for analysis, using fixed-effect (treatment) and random-effect (participants). GMR and 90% CI was calculated using exponentiation of treatment LSMs difference.|||0.07|0.04|
71154080|NCT04941482|141800635|SUPERIORITY||Mean Difference (Net)|-7.6|STANDARD_ERROR_OF_MEAN|5.6|<|0.05|TWO_SIDED|95.0|-18.8|3.7||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Treatment Difference = Intervention group - Control group|We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.|(1) Variables with multiple measurements over time were compared using the repeated measures ANOVA test to assess changes in Physical domain score of Stroke Impact Scale before and after intervention in two groups, calculating the time\*group interaction; (2) Effect sizes after intervention are measured using Cohen's D, with values indicating small (d = 0.2), medium (d = 0.5), and large (d ≥ 0.8) effects.|3.7|-18.8|<0.05
70973108|NCT02889796|141453143|SUPERIORITY||Difference in Response Rates|26.7|||<|0.001|TWO_SIDED|95.0|20.6|32.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||32.8|20.6|<0.001
70973109|NCT02889796|141453143|SUPERIORITY||Difference in Response Rates|19.9|||<|0.001|TWO_SIDED|95.0|13.6|26.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||26.2|13.6|<0.001
71094598|NCT00407511|141697166|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||End of treatment/last observation carried forward (EOT/LOCF): value consists of the mean of the last 7 post-baseline visits scores. Mean change: the arithmetic mean change and p-value from the single sample t-test. If \< = 7 and \> = 4 post-baseline scores were available, the mean pain score was computed using the available scores. The mean was not calculated if there were less than 4 post-baseline scores prior to study termination.||||< 0.0001
70973110|NCT02889796|141453144|SUPERIORITY||Least Squares Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.034|<|0.001|TWO_SIDED|95.0|-0.36|-0.22||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|Mixed effects model for repeated measure|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from mixed effects model for repeated measures (MMRM). Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.22|-0.36|<0.001
71094599|NCT00407511|141697167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.6|-2.8|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 4||-2.8|-3.6|< 0.0001
71094600|NCT00407511|141697167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-4.3|-3.5|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8||-3.5|-4.3|< 0.0001
71094601|NCT00407511|141697167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-4.5|-3.7|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12||-3.7|-4.5|< 0.0001
71094602|NCT00407511|141697168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-4.7|-3.7|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8, FAS. Week 8: subjects were only included if their visit fell within the computed week (49 to 63 days).||-3.7|-4.7|< 0.0001
71094603|NCT00407511|141697168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-5.1|-4.1|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12: subjects were only included if their visit fell within the computed week (\>= 78 days).||-4.1|-5.1|< 0.0001
71094604|NCT00407511|141697168|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||EOT/LOCF: last post-baseline value; mean change from Baseline was the arthmetic mean change and the p-value was from the single-sample t-test.||||< 0.0001
71094605|NCT00407511|141697169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-4.2|-3.4|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8: subjects were only included if their visit fell within the computed week (Day 49 to 63).||-3.4|-4.2|< 0.0001
70973111|NCT02889796|141453144|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.034|<|0.001|TWO_SIDED|95.0|-0.24|-0.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.10|-0.24|<0.001
70973112|NCT02889796|141453145|SUPERIORITY||Difference in Response Rates|24.8|||<|0.001|TWO_SIDED|95.0|19.6|30.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12.||30.0|19.6|<0.001
70973113|NCT02889796|141453145|SUPERIORITY||Difference in Response Rates|14.5|||<|0.001|TWO_SIDED|95.0|9.7|19.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12.||19.3|9.7|<0.001
70973114|NCT02889796|141453145|NON_INFERIORITY|For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) \< 2.6 using non-responder imputation (NRI).|||||<|0.001||||||P-value of non-inferiority test was calculated from approach proposed by \[Liu 2014\].|Method proposed by [Liu 2014]|||Filgotinib 200 mg vs Adalimumab at Week 12.||||<0.001
70973115|NCT02889796|141453145|NON_INFERIORITY|For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) \< 2.6 using NRI.||||||0.002||||||P-value of non-inferiority test was calculated from approach proposed by \[Liu 2014\].|Method proposed by [Liu 2014]|||Filgotinib 100 mg vs Adalimumab at Week 12.||||0.002
70973116|NCT02889796|141453145|SUPERIORITY||Difference in Response Rates|10.4||||0.001|TWO_SIDED|95.0|3.9|17.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Adalimumab at Week 12.||17.0|3.9|0.001
70973117|NCT02889796|141453145|SUPERIORITY||Difference in Response Rates|0.1||||0.99|TWO_SIDED|95.0|-6.2|6.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Adalimumab at Week 12.||6.3|-6.2|0.99
70973118|NCT02889796|141453146|SUPERIORITY||Least Squares Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.078|<|0.001|TWO_SIDED|95.0|-0.43|-0.12||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.12|-0.43|<0.001
71032280|NCT02678286|141573353|SUPERIORITY|||||||0.0434||||||Row 2 (SPID12)|t-test, 2 sided|||||||0.0434
71032281|NCT02678286|141573353|SUPERIORITY|||||||0.004||||||Row 3 (SPID48)|t-test, 2 sided|||||||0.0040
71032282|NCT02678286|141573353|SUPERIORITY|||||||0.0028||||||Row 4 (SPID24-48)|t-test, 2 sided|||||||0.0028
71032283|NCT02678286|141573354|SUPERIORITY|||||||0.7572|||||||Log Rank|||||||0.7572
71032284|NCT02678286|141573355|SUPERIORITY|||||||0.6559||||||Row 1 (Hour 0-24)|Cochran-Mantel-Haenszel|||||||0.6559
71032285|NCT02678286|141573355|SUPERIORITY|||||||0.0014||||||Row 2 (Hour 24-48)|Cochran-Mantel-Haenszel|||||||0.0014
71032286|NCT02678286|141573355|SUPERIORITY|||||||0.4994||||||Row 3 (Hour 0-48)|Cochran-Mantel-Haenszel|||||||0.4994
71032287|NCT02678286|141573356|SUPERIORITY|||||||0.0275||||||Row 1 (Hour 0-24)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site||||||0.0275
71032288|NCT02678286|141573356|SUPERIORITY|||||||0.0009||||||Row 2 (Hour 24-48)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site||||||0.0009
71032289|NCT02678286|141573356|SUPERIORITY|||||||0.0027||||||Row 3 (Hour 0-48)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site||||||0.0027
71032290|NCT02678286|141573357|SUPERIORITY|||||||0.005|||||||Log Rank|||||||0.0050
71032291|NCT02678286|141573358|SUPERIORITY|||||||0.5096|||||||Log Rank|||||||0.5096
71032292|NCT02678286|141573359|SUPERIORITY|||||||0.389|||||||Cochran-Mantel-Haenszel|||||||0.3890
71032293|NCT02678286|141573360|SUPERIORITY|||||||0.0178|||||||Cochran-Mantel-Haenszel|||||||0.0178
71032294|NCT02678286|141573361|SUPERIORITY|||||||0.1888|||||||Cochran-Mantel-Haenszel|||||||0.1888
71032295|NCT02678286|141573362|SUPERIORITY|||||||0.0788|||||||Cochran-Mantel-Haenszel|||||||0.0788
71032296|NCT02678286|141573363|SUPERIORITY|||||||0.0607|||||||Cochran-Mantel-Haenszel|P-value was derived from comparisons between N1539 and Placebo via General Association of CMH Test controlling for investigational site||||||0.0607
71032297|NCT02678286|141573364|SUPERIORITY|||||||0.0027|||||||Cochran-Mantel-Haenszel|P-value was derived from comparisons between N1539 and Placebo via General Association of CMH Test controlling for investigational site||||||0.0027
71032298|NCT00234286|141573367|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.009|TWO_SIDED|95.0|1.09|1.76|||Generalized Estimating Equation|||||1.76|1.09|.009
71032299|NCT00234286|141573368|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.09|TWO_SIDED|95.0|0.95|1.96|||Generalized Estimating Equation|||||1.96|0.95|0.09
71032300|NCT00234286|141573369|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.69|TWO_SIDED|95.0|0.59|1.42|||Generalized Estimating Equation|||||1.42|0.59|0.69
71094606|NCT00407511|141697169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-4.5|-3.7|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12: subjects were only included if their visit fell within the computed week (\>= Day 78)||-3.7|-4.5|< 0.0001
70920349|NCT00444600|141331182|SUPERIORITY_OR_OTHER_LEGACY||Proportion|0.0|||||TWO_SIDED|95.0|-6.0|6.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥15 letter worsening from sham+prompt laser at 1 year||6|-6|
70920350|NCT00444600|141331182|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.21||||0.009|TWO_SIDED|95.0|0.05|0.87|||Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter worsening comparison with sham+prompt laser at 1 year||0.87|0.05|0.009
70920351|NCT00444600|141331182|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.28||||0.01|TWO_SIDED|95.0|0.08|0.97|||Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter worsening comparison with sham+prompt laser at 1 year||0.97|0.08|0.01
70973119|NCT02889796|141453146|SUPERIORITY||Least Squares Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.078||0.001|TWO_SIDED|95.0|-0.4|-0.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.10|-0.40|0.001
70973120|NCT02889796|141453147|SUPERIORITY||Difference in Response Rates|26.3|||<|0.001|TWO_SIDED|95.0|20.2|32.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||32.4|20.2|<0.001
70973121|NCT02889796|141453147|SUPERIORITY||Difference in Response Rates|15.4|||<|0.001|TWO_SIDED|95.0|9.4|21.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||21.4|9.4|<0.001
70973122|NCT02889796|141453147|NON_INFERIORITY|For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) ≤ 3.2 using NRI.|||||<|0.001||||||P-value of non-inferiority test was calculated from approach proposed by \[Liu 2014\].|Method proposed by [Liu 2014]|||Filgotinib 200 mg vs Adalimumab at Week 12||||<0.001
70973123|NCT02889796|141453147|NON_INFERIORITY|For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) ≤ 3.2 using NRI.||||||0.054||||||P-value of non-inferiority test was calculated from approach proposed by \[Liu 2014\].|Method proposed by [Liu 2014]|||Filgotinib 100 mg vs Adalimumab at Week 12||||0.054
70973124|NCT02889796|141453147|SUPERIORITY||Difference in Response Rates|6.3||||0.069|TWO_SIDED|95.0|-1.0|13.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Adalimumab at Week 12||13.6|-1.0|0.069
70973125|NCT02889796|141453147|SUPERIORITY||Difference in Response Rates|-4.6||||0.18|TWO_SIDED|95.0|-11.8|2.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Adalimumab at Week 12||2.6|-11.8|0.18
70973126|NCT02889796|141453148|SUPERIORITY||Least Squares Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|2.8|4.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.6|2.8|<0.001
70973127|NCT02889796|141453148|SUPERIORITY||Least Squares Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|2.2|4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.0|2.2|<0.001
70973128|NCT02889796|141453149|SUPERIORITY||Least Squares Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|1.7|3.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.9|1.7|<0.001
70973129|NCT02889796|141453149|SUPERIORITY||Least Squares Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|1.5|3.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.7|1.5|<0.001
71094607|NCT00407511|141697169|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||EOT/LOCF: last post-baseline value; mean change from Baseline was the arthmetic mean change and the p-value was from the single-sample t-test.||||< 0.0001
70920352|NCT00444600|141331182|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.02||||0.95|TWO_SIDED|95.0|0.47|2.2|||Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter worsening comparison with sham+prompt laser at 1 year||2.20|0.47|0.95
70973130|NCT02889796|141453150|SUPERIORITY||Difference in Response Rates|8.0|||<|0.001|TWO_SIDED|95.0|5.1|10.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 2||10.9|5.1|<0.001
70973131|NCT02889796|141453150|SUPERIORITY||Difference in Response Rates|4.8|||<|0.001|TWO_SIDED|95.0|2.3|7.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 2||7.3|2.3|<0.001
70973132|NCT02889796|141453150|SUPERIORITY||Difference in Response Rates|16.4|||<|0.001|TWO_SIDED|95.0|11.9|20.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||20.9|11.9|<0.001
70973133|NCT02889796|141453150|SUPERIORITY||Difference in Response Rates|7.0|||<|0.001|TWO_SIDED|95.0|3.1|10.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||10.9|3.1|<0.001
70973134|NCT02889796|141453150|SUPERIORITY||Difference in Response Rates|27.4|||<|0.001|TWO_SIDED|95.0|21.4|33.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||33.3|21.4|<0.001
70973135|NCT02889796|141453150|SUPERIORITY||Difference in Response Rates|16.7|||<|0.001|TWO_SIDED|95.0|10.9|22.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||22.5|10.9|<0.001
70973136|NCT02889796|141453150|SUPERIORITY||Difference in Response Rates|24.6|||<|0.001|TWO_SIDED|95.0|18.3|31.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||31.0|18.3|<0.001
70973137|NCT02889796|141453150|SUPERIORITY||Difference in Response Rates|19.4|||<|0.001|TWO_SIDED|95.0|13.1|25.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||25.8|13.1|<0.001
70973138|NCT02889796|141453152|SUPERIORITY||Difference in Response Rates|2.3||||0.008|TWO_SIDED|95.0|0.5|4.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 2||4.1|0.5|0.008
70973139|NCT02889796|141453152|SUPERIORITY||Difference in Response Rates|0.8||||0.18|TWO_SIDED|95.0|-0.5|2.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 2||2.2|-0.5|0.18
70973140|NCT02889796|141453152|SUPERIORITY||Difference in Response Rates|7.6|||<|0.001|TWO_SIDED|95.0|4.6|10.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||10.6|4.6|<0.001
70973141|NCT02889796|141453152|SUPERIORITY||Difference in Response Rates|1.9||||0.067|TWO_SIDED|95.0|-0.3|4.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||4.0|-0.3|0.067
70973142|NCT02889796|141453152|SUPERIORITY||Difference in Response Rates|19.4|||<|0.001|TWO_SIDED|95.0|14.6|24.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||24.1|14.6|<0.001
71032301|NCT00234286|141573370|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.03|TWO_SIDED|95.0|0.53|0.96|||Generalized Estimating Equations|||||0.96|0.53|.03
71032302|NCT00234286|141573371|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.15|TWO_SIDED|95.0|0.38|1.16|||Generalized Estimating Equation|||||1.16|0.38|0.15
71032303|NCT00234286|141573372|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.86|TWO_SIDED|95.0|0.67|1.62|||Generalized Estimating Equation|||||1.62|0.67|0.86
71032304|NCT00234286|141573373|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.09|TWO_SIDED|95.0|0.95|1.96|||Generalized Estimating Equation|||||1.96|0.95|0.09
71032305|NCT00234286|141573374|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.98||||0.01|TWO_SIDED|95.0|1.17|3.36|||Generalized Estimating Equation|||||3.36|1.17|0.01
71032306|NCT00234286|141573375|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.36|TWO_SIDED|95.0|0.73|2.35|||Generalized Estimating Equation|||||2.35|0.73|0.36
71032307|NCT00234286|141573376|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.01|TWO_SIDED|95.0|1.08|1.77|||Generalized Estimating Equation|||||1.77|1.08|0.01
71032308|NCT00234286|141573377|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.76|TWO_SIDED|95.0|0.7|1.3|||Generalized Estimating Equation|||||1.30|0.70|0.76
71032309|NCT00234286|141573378|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.77||||0.004|TWO_SIDED|95.0|1.41|5.44|||Generalized Estimating Equation|||||5.44|1.41|.004
71032310|NCT00234286|141573379|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.12||||0.007|TWO_SIDED|95.0|1.51|11.28|||Generalized Estimating Equations|||||11.28|1.51|0.007
71032311|NCT00234286|141573380|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.14|TWO_SIDED|95.0|0.84|3.2|||Generalized Estimating Equations|||||3.20|0.84|0.14
71032312|NCT00234286|141573381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.003|TWO_SIDED|95.0|1.15|1.88|||Generalized Estimating Equation|||||1.88|1.15|.003
71032313|NCT00234286|141573382|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.45||||0.19|TWO_SIDED|95.0|0.62|9.7|||Generalized Estimation Equations|||||9.70|0.62|0.19
71032314|NCT02481830|141573394|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.1144|TWO_SIDED|95.0|0.72|1.04|||Log Rank||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab over Topotecan/Amrubicin|||1.04|0.72|0.1144
71032315|NCT02481830|141573395|SUPERIORITY||Hazard Ratio (HR)|1.39|||||TWO_SIDED|95.0|1.16|1.66|||||Hazard Ratio is Nivolumab over Topotecan/Amrubicin using Stratified Cox proportional hazard model|||1.66|1.16|
71032316|NCT02481830|141573396|SUPERIORITY||Estimate of Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.49|1.24|||||Strata adjusted odds ratio (Nivolumab over Topotecan/Amrubicin) using Mantel-Haenszel method|||1.24|0.49|
71032317|NCT02481830|141573397|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.73|1.04|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab over Topotecan/Amrubicin|||1.04|0.73|
71032318|NCT04627038|141573398|SUPERIORITY||Posterior Mean Difference|0.09|||||TWO_SIDED|95.0|-0.51|0.67|||||Posterior mean difference with 95% credible interval is reported.|||0.67|-0.51|
70920353|NCT00444600|141331183|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.0|||<|0.001|TWO_SIDED|95.0|1.52|2.64||Confidence intervals are adjusted for multiple comparisons.|Regression, Logistic|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for comparison with sham+prompt laser||2.64|1.52|<0.001
70920354|NCT00444600|141331183|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.55||||0.001|TWO_SIDED|95.0|1.13|2.13||Confidence intervals adjusted for multiple comparisons|Regression, Logistic|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for comparison with sham+prompt laser||2.13|1.13|0.001
70920355|NCT00444600|141331183|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.76|||<|0.001||95.0|1.31|2.36||Confidence intervals adjusted for multiple comparisons.|Regression, Logistic|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for comparison with sham+prompt laser||2.36|1.31|<0.001
70920356|NCT00444600|141331193|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||95.0|||||GEE repeated measures|||P value for comparison with sham||||0.08
70920357|NCT00444600|141331193|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||95.0|||||GEE repeated measures|||P value for comparison with sham||||0.17
70920358|NCT00444600|141331194|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0|||||GEE repeated measures|||P value for comparison with sham||||0.03
70920359|NCT00444600|141331194|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||95.0|||||GEE repeated measures|||P value for comparison with sham||||0.17
70920360|NCT00444600|141331198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.73|||<|0.001|TWO_SIDED|95.0|-1.01|-0.44||Confidence intervals are adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline optical coherence tomography (OCT) retinal volume, OCT retinal thickness and visual acuity and correlation between 2 study eyes.||Difference in mean change from sham+prompt laser||-0.44|-1.01|<0.001
70920361|NCT00444600|141331198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.68|||<|0.001|TWO_SIDED|95.0|-0.96|-0.41||Confidence intervals adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline optical coherence tomography (OCT) retinal volume, OCT retinal thickness and visual acuity and correlation between 2 study eyes.||Difference in mean change from sham+prompt laser||-0.41|-0.96|<0.001
70920362|NCT00444600|141331198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.62|||<|0.001|TWO_SIDED|95.0|-0.91|-0.34||Confidence intervals are adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline optical coherence tomography (OCT) retinal volume, OCT retinal thickness and visual acuity and correlation between 2 study eyes.||Difference in mean change from sham+prompt laser||-0.34|-0.91|<0.001
70920363|NCT05132478|141331200|SUPERIORITY|||||||0.72|||||||Regression, Logistic|||||||0.720
70920364|NCT05132478|141331201|SUPERIORITY|||||||0.743|||||||t-test, 2 sided|||||||0.743
70920365|NCT05132478|141331202|SUPERIORITY|||||||0.228|||||||t-test, 2 sided|||baseline||||0.228
70920366|NCT05132478|141331202|SUPERIORITY|||||||0.176|||||||t-test, 2 sided|||Post-Intervention||||0.176
70920367|NCT05132478|141331203|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||baseline||||0.410
70920368|NCT05132478|141331203|SUPERIORITY|||||||0.351|||||||ANOVA|||Post-Intervention||||0.351
70973143|NCT02889796|141453152|SUPERIORITY||Difference in Response Rates|11.8|||<|0.001|TWO_SIDED|95.0|7.5|16.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||16.2|7.5|<0.001
70920369|NCT05132478|141331204|SUPERIORITY||||||<|0.001||||||calculated p-value|t-test, 2 sided|||||||<0.001
70920370|NCT05132478|141331205|SUPERIORITY||||||<|0.001||||||calculated p-value|t-test, 2 sided|||||||<0.001
70920371|NCT01852071|141331206|SUPERIORITY||Difference in percentages|14.29|||||TWO_SIDED|95.0|-5.4|42.81||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients alive at 1-year post-treatment with OTL-101. Results are reported as percentage difference in OS of historical control group from OTL-101 on-study subjects.||42.81|-5.40|
70920372|NCT01852071|141331206|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients alive at 1-year post-treatment with OTL-101. Results are reported as percentage difference in OS of historical control group from OTL-101 on-study subjects.||||
70920373|NCT01852071|141331206|SUPERIORITY||Difference in percentages|7.69|||||TWO_SIDED|95.0|-10.08|25.13||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (all control patients) were compared to the percentage of study patients alive at 1-year post-treatment with OTL-101. Results are reported as percentage difference in OS of historical control group from OTL-101 on-study subjects.||25.13|-10.08|
70920374|NCT01852071|141331207|SUPERIORITY||Difference in percentages|35.71|||||TWO_SIDED|95.0|11.21|64.86||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101. Results are reported as percentage difference in EvFS of historical control group from OTL-101 on-study subjects.||64.86|11.21|
70920375|NCT01852071|141331207|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101. Results are reported as percentage difference in EvFS of historical control group from OTL-101 on-study subjects.||||
70920376|NCT01852071|141331207|SUPERIORITY||Difference in percentages|19.23|||||TWO_SIDED|95.0|0.71|39.35||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (all control patients) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101. Results are reported as percentage difference in EvFS of historical control group from OTL-101 on-study subjects.||39.35|0.71|
70920377|NCT01852071|141331208|SUPERIORITY||Difference in percentages|14.29|||||TWO_SIDED|95.0|-5.4|42.81||||||Percentage of patients alive at 2-years post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients alive at 2-years post-treatment with OTL-101. Results are reported as percentage difference in OS of historical control group from OTL-101 on-study subjects.||42.81|-5.40|
70973144|NCT02889796|141453152|SUPERIORITY||Difference in Response Rates|21.3|||<|0.001|TWO_SIDED|95.0|15.7|26.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||26.9|15.7|<0.001
71032319|NCT04627038|141573399|SUPERIORITY||Posterior Mean Difference|0.95|||||TWO_SIDED|95.0|-0.07|1.96|||||Posterior mean difference with 95% credible interval is reported.|||1.96|-0.07|
70973145|NCT02889796|141453152|SUPERIORITY||Difference in Response Rates|14.6|||<|0.001|TWO_SIDED|95.0|9.2|20.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||20.0|9.2|<0.001
70973146|NCT02889796|141453154|SUPERIORITY||Difference in Response Rates|22.3|||<|0.001|TWO_SIDED|95.0|16.7|27.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 2||27.9|16.7|<0.001
70973147|NCT02889796|141453154|SUPERIORITY||Difference in Response Rates|12.6|||<|0.001|TWO_SIDED|95.0|7.2|17.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 2||17.9|7.2|<0.001
70973148|NCT02889796|141453154|SUPERIORITY||Difference in Response Rates|19.8|||<|0.001|TWO_SIDED|95.0|13.4|26.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||26.1|13.4|<0.001
70973149|NCT02889796|141453154|SUPERIORITY||Difference in Response Rates|13.8|||<|0.001|TWO_SIDED|95.0|7.5|20.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||20.2|7.5|<0.001
70973150|NCT02889796|141453154|SUPERIORITY||Difference in Response Rates|18.9|||<|0.001|TWO_SIDED|95.0|13.0|24.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||24.9|13.0|<0.001
70973151|NCT02889796|141453154|SUPERIORITY||Difference in Response Rates|18.6|||<|0.001|TWO_SIDED|95.0|12.6|24.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||24.5|12.6|<0.001
70973152|NCT02889796|141453156|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.025|<|0.001|TWO_SIDED|95.0|-0.22|-0.12||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.12|-0.22|<0.001
70973153|NCT02889796|141453156|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.025|<|0.001|TWO_SIDED|95.0|-0.14|-0.04||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.04|-0.14|<0.001
70973154|NCT02889796|141453156|SUPERIORITY||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.028|<|0.001|TWO_SIDED|95.0|-0.24|-0.13||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.13|-0.24|<0.001
70973155|NCT02889796|141453156|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.028|<|0.001|TWO_SIDED|95.0|-0.15|-0.04||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.04|-0.15|<0.001
70973156|NCT02889796|141453156|SUPERIORITY||Least Squares Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.037|<|0.001|TWO_SIDED|95.0|-0.34|-0.19||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.19|-0.34|<0.001
70973157|NCT02889796|141453156|SUPERIORITY||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.037|<|0.001|TWO_SIDED|95.0|-0.26|-0.11||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.11|-0.26|<0.001
70973158|NCT02889796|141453158|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-4.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-4.0|<0.001
70973159|NCT02889796|141453158|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6||0.01|TWO_SIDED|95.0|-3.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-3.0|0.010
71032320|NCT04627038|141573400|SUPERIORITY||Posterior Mean Difference|0.24|||||TWO_SIDED|95.0|-0.24|0.72|||||Posterior mean difference with 95% credible interval is reported.|||0.72|-0.24|
71032321|NCT04627038|141573401|SUPERIORITY||Posterior Mean Difference|3.84|||||TWO_SIDED|95.0|0.39|7.2|||||Posterior mean difference with 95% credible interval is reported.|||7.20|0.39|
71032322|NCT04627038|141573402|SUPERIORITY||Posterior Mean Difference|-0.1|||||TWO_SIDED|95.0|-0.48|0.28|||||Posterior mean difference with 95% credible interval is reported.|||0.28|-0.48|
71032323|NCT04627038|141573403|SUPERIORITY||Posterior Mean Difference|0.31|||||TWO_SIDED|95.0|-0.32|0.95|||||Posterior mean difference with 95% credible interval is reported.|||0.95|-0.32|
70973160|NCT02889796|141453158|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-5.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-5.0|<0.001
70973161|NCT02889796|141453158|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|<0.001
70973162|NCT02889796|141453158|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-5.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-5.0|<0.001
70973163|NCT02889796|141453158|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|<0.001
71094608|NCT00407511|141697172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.1|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001||95.0|-22.3|-14.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 1: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 1 assessment if their visit fell within Days 4 to 10.||-14.0|-22.3|< 0.0001
71094609|NCT00407511|141697172|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-28.2|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001||95.0|-32.4|-24.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 2: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 2 assessment if their visit fell within Days 11 to 17.||-24.0|-32.4|< 0.0001
70973164|NCT02889796|141453158|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-4.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-4.0|<0.001
70973165|NCT02889796|141453158|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
70973166|NCT02889796|141453160|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.002|TWO_SIDED|95.0|-2.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-2.0|0.002
70973167|NCT02889796|141453160|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.047|TWO_SIDED|95.0|-2.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-2.0|0.047
70973168|NCT02889796|141453160|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
71032324|NCT04627038|141573404|SUPERIORITY||Posterior Mean Difference|6.24|||||TWO_SIDED|95.0|-1.05|13.56|||||Posterior mean difference with 95% credible interval is reported.|||13.56|-1.05|
71032325|NCT04627038|141573405|SUPERIORITY||Posterior Mean Difference|0.16|||||TWO_SIDED|95.0|-0.14|0.46|||||Posterior mean difference with 95% credible interval is reported.|||0.46|-0.14|
71032326|NCT04627038|141573406|SUPERIORITY||Posterior Mean Difference|-0.82|||||TWO_SIDED|95.0|-166.74|165.52|||||Posterior mean difference with 95% credible interval is reported.|||165.52|-166.74|
71032327|NCT04627038|141573407|SUPERIORITY||Posterior Mean Difference|-0.02|||||TWO_SIDED|95.0|-0.09|0.06|||||Posterior mean difference with 95% credible interval is reported.|||0.06|-0.09|
71032328|NCT03956862|141573413|SUPERIORITY||Mean Difference (Net)|-0.2||||0.9499|TWO_SIDED|95.0|-7.6|7.1|||Mixed Models Analysis||GB001 vs. Placebo|||7.1|-7.6|0.9499
70973169|NCT02889796|141453160|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
70973170|NCT02889796|141453160|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
70973171|NCT02889796|141453160|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-2.0|<0.001
70973172|NCT02889796|141453160|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
70973173|NCT02889796|141453160|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-2.0|<0.001
70973174|NCT02889796|141453162|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-11.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-11.0|<0.001
70973175|NCT02889796|141453162|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-7.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-7.0|<0.001
70973176|NCT02889796|141453162|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-12.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-12.0|<0.001
71094610|NCT00407511|141697172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-34.3|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001||95.0|-38.5|-30.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 3: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 3 assessment if their visit fell within Days 18 to 24.||-30.0|-38.5|< 0.0001
70973177|NCT02889796|141453162|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-7.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-7.0|<0.001
70973178|NCT02889796|141453162|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-16.0|-10.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-10.0|-16.0|<0.001
71032329|NCT03956862|141573414|SUPERIORITY||Mean Difference (Net)|-0.3||||0.6778|TWO_SIDED|95.0|-1.8|1.2|||ANCOVA||GB001 vs. Placebo|||1.2|-1.8|0.6778
71032330|NCT03956862|141573415|SUPERIORITY||Mean Difference (Net)|0.1||||0.7914|TWO_SIDED|95.0|-0.7|0.9|||Mixed Models Analysis||GB001 vs. Placebo|||0.9|-0.7|0.7914
71032331|NCT03956862|141573416|SUPERIORITY||Hazard Ratio (HR)|0.944||||0.8916|TWO_SIDED|95.0|0.41|2.173|||Regression, Cox||GB001 vs Placebo|||2.173|0.410|0.8916
71032332|NCT03956862|141573417|SUPERIORITY||Mean Difference (Net)|0.191||||0.1635|TWO_SIDED|95.0|-0.077|0.459|||Mixed Models Analysis||GB001 vs. Placebo|||0.459|-0.077|0.1635
71032333|NCT03956862|141573418|SUPERIORITY||Mean Difference (Net)|0.632||||0.1742|TWO_SIDED|95.0|-0.28|1.544|||Mixed Models Analysis||GB001 vs. Placebo|||1.544|-0.280|0.1742
71032334|NCT03956862|141573419|SUPERIORITY||Mean Difference (Net)|0.9||||0.4851|TWO_SIDED|95.0|-1.6|3.4|||ANCOVA||GB001 vs. Placebo|||3.4|-1.6|0.4851
71032335|NCT03956862|141573420|SUPERIORITY||Hazard Ratio (HR)|0.544||||0.3898|TWO_SIDED|95.0|0.136|2.178|||Regression, Cox||GB001 vs Placebo|||2.178|0.136|0.3898
71094611|NCT00407511|141697172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-40.9|STANDARD_ERROR_OF_MEAN|2.2|<|0.0001||95.0|-45.2|-36.7|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 4: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 4 assessment if their visit fell within days 25 to 35.||-36.7|-45.2|< 0.0001
70973179|NCT02889796|141453162|SUPERIORITY||Least Squares Mean Difference|-10.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-12.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-12.0|<0.001
70973180|NCT02889796|141453162|SUPERIORITY||Least Squares Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-14.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-14.0|<0.001
70973181|NCT02889796|141453162|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-11.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-11.0|<0.001
70973182|NCT02889796|141453164|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-10.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-10.0|<0.001
70973183|NCT02889796|141453164|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-8.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-8.0|<0.001
70973184|NCT02889796|141453164|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-11.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-11.0|<0.001
70973185|NCT02889796|141453164|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-9.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-9.0|<0.001
70973186|NCT02889796|141453164|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-10.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-10.0|<0.001
71094612|NCT00407511|141697172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-45.8|STANDARD_ERROR_OF_MEAN|2.2|<|0.0001||95.0|-50.2|-41.4|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 8 assessment if their visit fell within Days 49 to 63.||-41.4|-50.2|< 0.0001
70973187|NCT02889796|141453164|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-10.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-10.0|<0.001
70973188|NCT02889796|141453164|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-11.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-11.0|<0.001
71094613|NCT00407511|141697172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-48.4|STANDARD_ERROR_OF_MEAN|2.2|<|0.0001||95.0|-52.8|-44.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 12 assessment if their visit fell \>= Day 78.||-44.0|-52.8|< 0.0001
71094614|NCT00407511|141697172|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||EOT/LOCF: last post-baseline assessment. Mean change is the arithmetic mean change; p-value is from a single-sample t-test.||||< 0.0001
71094615|NCT00407511|141697173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.7|STANDARD_ERROR_OF_MEAN|2.4|<|0.0001||95.0|-43.4|-33.9|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8: LS mean, p-value, and confidence interval are based on a repeated measures effect model with baseline value, center, and week as fixed effects; subjects were included as a random effect. Subjects were included in the Week 8 assessment only if their visit fell within Days 49 and 63.||-33.9|-43.4|< 0.0001
71094616|NCT00407511|141697173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-40.7|STANDARD_ERROR_OF_MEAN|2.4|<|0.0001||95.0|-45.5|-35.9|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12: LS mean, p-value, and confidence interval are based on a repeated measures effect model with baseline value, center, and week as fixed effects; subjects were included as a random effect. Subjects were included in the Week 12 assessment only if their visit fell \>=Day 78.||-35.9|-45.5|< 0.0001
71094617|NCT00407511|141697173|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||EOT/LOCF: last post-baseline assessment. Mean change= arithmetic mean change; p-value is from a single-sample t-test.||||< 0.0001
71094618|NCT00407511|141697174|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-1.4|-0.7|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 1: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-0.7|-1.4|< 0.0001
71094619|NCT00407511|141697174|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-2.2|-1.5|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 2: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-1.5|-2.2|< 0.0001
71094620|NCT00407511|141697174|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-2.9|-2.2|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 3: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.2|-2.9|< 0.0001
71094621|NCT00407511|141697174|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.2|-2.5|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 4: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.5|-3.2|< 0.0001
71094622|NCT00407511|141697174|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.3|-2.6|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 5: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.6|-3.3|< 0.0001
71094623|NCT00407511|141697174|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.4|-2.6|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 6: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.6|-3.4|< 0.0001
71094624|NCT00407511|141697174|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.5|-2.8|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 7: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.8|-3.5|< 0.0001
71094625|NCT00407511|141697174|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.6|-2.8|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.8|-3.6|< 0.0001
71094626|NCT00407511|141697174|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.7|-2.9|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 9: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.9|-3.7|< 0.0001
71094627|NCT00407511|141697174|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.7|-3.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 10: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-3.0|-3.7|< 0.0001
71094628|NCT00407511|141697174|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.8|-3.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Visit 11: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-3.0|-3.8|< 0.0001
71094629|NCT00407511|141697174|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.7|-3.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-3.0|-3.7|< 0.0001
71094630|NCT00407511|141697174|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||EOT/LOCF value consists of the mean of the last 7 post-baseline sleep scores; mean change = arithmetic mean change; p-value: from single sample t-test.||||< 0.0001
71094631|NCT03439514|141697181|SUPERIORITY||Median Difference (Net)|4.936||||0.818|TWO_SIDED|95.0|-24.246|34.118||Two-sided p-value|Van Elteren test||The Week 24 change from baseline in 6MWT between PF 07265803 and placebo was estimated using the stratified HL median difference, considering only participants who survived 24 weeks.|||34.118|-24.246|0.818
70973189|NCT02889796|141453164|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-10.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-10.0|<0.001
70973190|NCT02889796|141453166|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-12.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-12.0|<0.001
70973191|NCT02889796|141453166|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-8.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-8.0|<0.001
70973192|NCT02889796|141453166|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-12.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-12.0|<0.001
70973193|NCT02889796|141453166|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-9.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-9.0|<0.001
70973194|NCT02889796|141453166|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-15.0|-9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-9.0|-15.0|<0.001
71094632|NCT03439514|141697187|OTHER||Hazard Ratio (HR)|0.43||||0.2257|TWO_SIDED|95.0|0.13|1.39|||Log Rank|||||1.39|0.13|0.2257
71094633|NCT03439514|141697188|OTHER||Hazard Ratio (HR)|1.19||||0.837|TWO_SIDED|95.0|0.3|4.63|||Log Rank|||||4.63|0.30|0.8370
71032336|NCT01363765|141573422|SUPERIORITY_OR_OTHER||notification rate ratio|1.59|||<|0.01|TWO_SIDED|95.0|1.32|1.87||NR were calculated using an aggregated database consisting of 896 strata for laboratory (n=14), study month (n=8), sex (n=2) and age group (n=4: \<15, 15-39, 40-59, and \>=60 years). Poisson regression modeling was used to analyze changes in TB TB NR|Clustered Avareged|Adjustment for municipality, age, sex, and baseline proportion of samples with a positive smear was by a population-averaged quasi-likelihood approach|"The numbers reported in the CONSORT flowchart refer to the diagnostic samples. NR were obtained crosslinking lab and notification databases, denominator was population/year."|cluster-averaged NNR=1.59 (CI95% 1.31-1.88) Absolute numbers informed in table do not allow calculation of notification rates; they are based on population size, not in total numbers and percentages||1.87|1.32|<0.01
71032337|NCT01363765|141573422|SUPERIORITY_OR_OTHER||notification rate ratio|1.7|||<|0.001|TWO_SIDED|95.0|1.51|1.92|||Mixed Models Analysis|Mixed multi-level model, time-adjusted||Secondary analysis: Mixed multi-level model||1.92|1.51|<0.001
71032338|NCT01363765|141573423|SUPERIORITY_OR_OTHER||incremental cost-effectiveness ratio|-84.07||||||95.0||||||Incremental cost-effectiveness ratio (ICER) per case detected||||||
71094634|NCT02175758|141697199|EQUIVALENCE|Equivalence was determined if the 90% confidence intervals (CI) were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|129.48|||||TWO_SIDED|90.0|109.96|152.48||||||AUCtau of GS-331007 for the 12 to \< 18 Years old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||152.48|109.96|
71094635|NCT02175758|141697199|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|109.8|||||TWO_SIDED|90.0|93.25|129.29||||||AUCtau of GS-331007 for the 6 to \< 12 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||129.29|93.25|
70920378|NCT01852071|141331208|SUPERIORITY||Difference in percentages|9.09|||||TWO_SIDED|95.0|-9.55|41.28||||||Percentage of patients alive at 2-years post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients alive at 2-years post-treatment with OTL-101. Results are reported as percentage difference in OS of historical control group from OTL-101 on-study subjects.||41.28|-9.55|
70920379|NCT01852071|141331208|SUPERIORITY||Difference in percentages|12.0|||||TWO_SIDED|95.0|-5.62|31.22||||||Percentage of patients alive at 2-years post-treatment in the historical control groups (all control patients) were compared to the percentage of study patients alive at 2-years post-treatment with OTL-101. Results are reported as percentage difference in OS of historical control group from OTL-101 on-study subjects.||31.22|-5.62|
70920380|NCT01852071|141331209|SUPERIORITY||Difference in percentages|50.0|||||TWO_SIDED|95.0|22.71|76.96||||||Percentage of patients with EvFS at 2-years post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with EvFS at 2-years post-treatment with OTL-101. Results are reported as percentage difference in EvFS of historical control group from OTL-101 on-study subjects.||76.96|22.71|
70920381|NCT01852071|141331209|SUPERIORITY||Difference in percentages|36.36|||||TWO_SIDED|95.0|9.8|69.21||||||Percentage of patients with EvFS at 2-years post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with EvFS at 2-years post-treatment with OTL-101. Results are reported as percentage difference in EvFS of historical control group from OTL-101 on-study subjects.||69.21|9.80|
70920382|NCT01852071|141331209|SUPERIORITY||Difference in percentages|44.0|||||TWO_SIDED|95.0|22.78|65.23||||||Percentage of patients with EvFS at 2-years post-treatment in the historical control groups (all control patients) were compared to the percentage of study patients with EvFS at 2-years post-treatment with OTL-101. Results are reported as percentage difference in EvFS of historical control group from OTL-101 on-study subjects.||65.23|22.78|
70920383|NCT01839331|141331235|SUPERIORITY|||||||0.004||||||Adjusted for injection volume (4 mL or 10 mL) and baseline WOMAC score.|ANOVA|||||||0.004
70920384|NCT01839331|141331235|SUPERIORITY|||||||0.017||||||Adjusted for injection volume and baseline WOMAC score.|ANOVA|||||||0.017
70920385|NCT01839331|141331235|SUPERIORITY|||||||0.093||||||Adjusted for injection volume and baseline WOMAC score.|ANOVA|||||||0.093
70920386|NCT01839331|141331236|SUPERIORITY|Adjusted for injection volume (4 mL or 10 mL) and baseline WOMAC score.||||||0.0442|||||||ANOVA|||||||0.0442
70920387|NCT01839331|141331237|SUPERIORITY|||||||0.4133||||||Adjusted for injection volume (4 mL or 10 mL) and baseline WOMAC score.|ANOVA|||||||0.4133
70920388|NCT01839331|141331238|SUPERIORITY|||||||0.0122||||||Adjusted for injection volume (4 mL or 10 mL) and baseline PGA|ANOVA|||||||0.0122
70973195|NCT02889796|141453166|SUPERIORITY||Least Squares Mean Difference|-10.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-13.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-13.0|<0.001
70973196|NCT02889796|141453166|SUPERIORITY||Least Squares Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-14.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-14.0|<0.001
70920389|NCT03224390|141331241|SUPERIORITY||Instrumental variables estimate|0.41|||||TWO_SIDED|95.0|-0.03|0.85||||||||.85|-.03|
70920390|NCT00703820|141331243|SUPERIORITY||Odds Ratio (OR)|1.87||||0.035|TWO_SIDED|95.0|1.03|3.41||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.0429 so that the overall level of the study is maintained at 0.05 across the 4 interim analyses and the final analysis.|Cochran-Mantel-Haenszel|The p-value was computed using an exact, risk-group stratified, two-sided test.|The odds ratio is defined as the ratio of the odds that a Clofarabine+Cytarabine patient is MRD positive to the odds that a Cytarabine+Daunorubicin+Etoposide patient is MRD positive.|The study was designed to test the null hypothesis that Cytarabine+Daunorubicin+Etoposide and Clofarabine+Cytarabine result in the same proportion of patients with positive MRD after 22 days. Power calculations indicate that enrollment of a total of 240 MRD-evaluable patients in a 5-stage Haybittle-Peto group sequential design gives 80% power at the 5% level to detect an odds ratio of 2.5. The design was developed using East statistical software.||3.41|1.03|0.035
70920391|NCT01985334|141331288|SUPERIORITY_OR_OTHER|||||||0.018|||||||linear mixed model|||||||0.0180
70920392|NCT01985334|141331289|NON_INFERIORITY_OR_EQUIVALENCE|"H0: Glycopyrronium (50 μg o.d.) \[randomized group B2\] was inferior to LABA or LAMA (random group B1) with respect to mean trough FEV1 after 12 weeks of treatment.~H0: μFEV1, NVA237 - μFEV1, LABA and/or LAMA \< -40 mL Ha: Glycopyrronium (50 μg o.d.) \[randomized group B2\] is non-inferior to LABA or LAMA (random group B1) with respect to mean trough FEV1 after 12 weeks of treatment.~Ha: μFEV1, NVA237 - μFEV1, LABA and/or LAMA ≥ -40 mL"|||||<|0.0001|||||||linear mixed model|||||||<0.0001
70920393|NCT01985334|141331290|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||linear mixed model|||||||<0.0001
70920394|NCT01985334|141331291|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||linear mixed model|||||||<0.0001
70920395|NCT01985334|141331292|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||linear mixed model|||||||<0.0001
70920396|NCT01985334|141331293|NON_INFERIORITY_OR_EQUIVALENCE|A difference of 0.6 points in TDI was adopted as boundary for non-inferiority|||||<|0.0001|||||||linear mixed model|||||||<0.0001
70920397|NCT01985334|141331294|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||linear mixed model|||||||<0.0001
70920398|NCT01985334|141331295|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||linear mixed model|||||||<0.0001
70920399|NCT01195883|141331304|SUPERIORITY||Risk Ratio (RR)|0.9||||0.51|TWO_SIDED|95.0|0.65|1.23|||GEE model|||||1.23|0.65|0.51
70920400|NCT01195883|141331305|SUPERIORITY||Risk Ratio (RR)|0.95||||0.42|TWO_SIDED|95.0|0.81|1.11|||Chi-squared|||||1.11|0.81|0.42
70920401|NCT01195883|141331306|SUPERIORITY||Risk Ratio (RR)|0.89||||0.26|TWO_SIDED|95.0|0.72|1.09|||Chi-squared|||||1.09|0.72|0.26
71032339|NCT01363765|141573424|SUPERIORITY_OR_OTHER||NRR|0.98||||0.923|TWO_SIDED|95.0|0.64|1.32||cluster-averaged adjusted NRR (notification rate ratio, not calculable from number shown, which are a proportion of tests. NRR calculated over a population/year denominator.|Agregated cluster-averaged|||||1.32|0.64|0.923
70920402|NCT01195883|141331307|SUPERIORITY||Odds Ratio (OR)|1.33||||0.4|TWO_SIDED|95.0|0.69|2.58|||Chi-squared|||||2.58|0.69|0.40
70920403|NCT00396084|141331308|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Mean adjusted aAUC for all 4 treatment groups over the 7 days of study drug administration||||<0.001
70920404|NCT00396084|141331308|SUPERIORITY_OR_OTHER|||||||0.041|||||||Wilcoxon (Mann-Whitney)|||Day 1. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.041
70920405|NCT00396084|141331308|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Wilcoxon (Mann-Whitney)|||Day 2. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.008
70920406|NCT00396084|141331308|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Wilcoxon (Mann-Whitney)|||Day 3. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.012
70920407|NCT00396084|141331308|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Wilcoxon (Mann-Whitney)|||Day 4. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.01
70920408|NCT00396084|141331308|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||Day 5. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.03
70920409|NCT00396084|141331308|SUPERIORITY_OR_OTHER|||||||0.091||95.0|||||Wilcoxon (Mann-Whitney)|||Day 6. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.091
70920410|NCT00396084|141331308|SUPERIORITY_OR_OTHER|||||||0.354||95.0|||||Wilcoxon (Mann-Whitney)|||Day 7. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.354
70920411|NCT00396084|141331312|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||Mean values of EBA Days 0 to 2 for the 4 treatment groups were compared.||||0.05
70920412|NCT00396084|141331312|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Two way comparison of INH against gatifloxacin using a simultaneous non-parametric procedure.||||0.01
70920413|NCT00396084|141331312|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||Two way comparison of INH against moxifloxacin using a simultaneous non-parametric procedure.||||0.02
70920414|NCT00396084|141331312|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Wilcoxon (Mann-Whitney)|||Two way comparison of INH against levofloxacin using a simultaneous non-parametric procedure.||||0.14
70920415|NCT00396084|141331313|SUPERIORITY_OR_OTHER|||||||0.51|||||||ANOVA|||Mean values of EBA Days 2 to 7 for the 4 treatment groups were compared.||||0.51
70920416|NCT00396084|141331313|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||The rate of fall in sputum cfu for the 4 treatment groups between day 2 and day 7 of monotherapy was estimated by the slope of the linear regression obtained from fitting the 6 sputum cfu values corresponding to days 2 through 7.||||0.16
70920417|NCT00396084|141331313|SUPERIORITY_OR_OTHER|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||EBA Days 2-7 for patients in the 3 fluoroquinolone groups were pooled and compared to bactericidal activity of patients in the INH arm.||||0.036
70920418|NCT00396084|141331314|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Mean adjusted aAUC for all 3 treatment groups over the 7 days of study drug administration||||<0.001
70920419|NCT00396084|141331314|SUPERIORITY_OR_OTHER|||||||0.023|||||||Wilcoxon (Mann-Whitney)|||Day 1. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.023
70920420|NCT00396084|141331314|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||Wilcoxon (Mann-Whitney)|||Day 2. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.018
70920421|NCT00396084|141331314|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||Day 3. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.03
70920422|NCT00396084|141331314|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Wilcoxon (Mann-Whitney)|||Day 4. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.012
70920423|NCT00396084|141331314|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon (Mann-Whitney)|||Day 5. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.003
70920424|NCT00396084|141331314|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon (Mann-Whitney)|||Day 6. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.003
70920425|NCT00396084|141331314|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Wilcoxon (Mann-Whitney)|||Day 7. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.004
70920426|NCT00396084|141331315|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANOVA|||Mean values of EBA Days 0 to 2 for the 3 treatments groups were compared.||||<0.01
70920427|NCT00396084|141331315|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Two way comparison of INH against Linezolid once daily using a simultaneous non-parametric procedure.||||<0.01
70920428|NCT00396084|141331315|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Mean EBA 0-2 of INH was compared to pooled Linezolid once daily and Linezolid twice daily results.||||<0.01
70920429|NCT00396084|141331318|SUPERIORITY_OR_OTHER|||||||0.25|||||||ANOVA|||Mean values EBA Days 2-7 for the 3 treatment groups were compared.||||0.25
70920430|NCT00396084|141331318|SUPERIORITY_OR_OTHER|||||||0.42|||||||ANOVA|||The rate of fall in sputum cfu for the 3 treatment groups between day 2 and day 7 of monotherapy was estimated by the slope of the linear regression obtained from fitting the 6 sputum cfu values corresponding to days 2 through 7.||||0.42
70920431|NCT00396084|141331318|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||EBA Days 2-7 for INH was compared to that of the pooled linezolid arms.||||0.14
70920432|NCT00212134|141331357|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
71094636|NCT02175758|141697199|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|149.67|||||TWO_SIDED|90.0|127.12|176.21||||||AUCtau of GS-331007 for the 3 to \< 6 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||176.21|127.12|
71094637|NCT02175758|141697201|SUPERIORITY||||||<|0.001|||||||2-sided exact 1-sample binomial test|||The SVR12 rate for the 12 to \< 18 Years Old group was compared with the historical SVR12 rate of 80% using a 2-sided exact 1-sample binomial test at the 0.05 significance level. If superiority was demonstrated in the 12 to \< 18 Years Old group, then the SVR12 rate for participants aged 3 to \< 12 years would be compared with 80% at the 0.05 significance level.||||<0.001
71032340|NCT01363765|141573425|SUPERIORITY_OR_OTHER||NRR|0.52||||0.004|TWO_SIDED|95.0|0.21|0.84||cluster-averaged adjusted NRR|Agregated cluster-averaged|||||0.84|0.21|0.004
71094638|NCT02175758|141697201|SUPERIORITY||||||<|0.001|||||||2-sided exact 1-sample binomial test|||The SVR12 rate for the 3 to \< 12 Years Old group was compared with the historical SVR12 rate of 80% using a 2-sided exact 1-sample binomial test at the 0.05 significance level.||||<0.001
71094639|NCT03927157|141697241|SUPERIORITY||Rate Ratio|0.26|||<|0.001|TWO_SIDED|95.0|0.17|0.39|||Negative Binomial Regression|||||0.39|0.17|<0.001
71094640|NCT03927157|141697242|SUPERIORITY||Least Squares Mean Difference|0.24|||<|0.001|TWO_SIDED|95.0|0.16|0.32|||Mixed Models Analysis|||||0.32|0.16|<0.001
71094641|NCT03927157|141697243|SUPERIORITY||Least Squares Means Difference|0.35||||0.001|TWO_SIDED|95.0|0.14|0.55|||Mixed Models Analysis|||||0.55|0.14|0.001
71094642|NCT03927157|141697244|SUPERIORITY||Least Squares Means Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.47|-0.15|||Mixed Models Analysis|||||-0.15|-0.47|<0.001
71094643|NCT03927157|141697245|SUPERIORITY||Least Squares Means Difference|-0.16||||0.001|TWO_SIDED|95.0|-0.27|-0.06|||Mixed Models Analysis|||||-0.06|-0.27|0.001
71032341|NCT02601560|141573432|SUPERIORITY_OR_OTHER|||||||0.095|||||||ANCOVA|||||||0.095
71094644|NCT00081458|141697270|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0|||||ANCOVA|||||||0.007
71094645|NCT00081458|141697271|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0|||||ANCOVA|||An efficacy responder was defined as achieving at least a 20% reduction from Baseline to Week 20 and maintained at Week 24 in weekly actual PN infusion volume.||||0.005
71094646|NCT03384966|141697272|SUPERIORITY||Odds Ratio (OR)|58.9|||<|0.0001|TWO_SIDED|97.5|22.4|154.8||A p-value significance level was set to 0.025, based on an overall Type-I error rate of 0.05 adjusted for multiple comparisons using a Bonferroni approach (two comparisons).|Chi-squared|||"The study aimed at assessing the efficacy of each selatogrel dose versus placebo. The proportion of responders for each of the two doses of selatogrel was compared to placebo.~No imputation was considered for handling missing values."||154.8|22.4|< 0.0001
71094647|NCT03384966|141697272|SUPERIORITY||Odds Ratio (OR)|61.2|||<|0.0001|TWO_SIDED|97.5|23.1|162.3||A p-value significance level was set to 0.025, based on an overall Type-I error rate of 0.05 adjusted for multiple comparisons using a Bonferroni approach (two comparisons).|Chi-squared|||"The study aimed at assessing the efficacy of each selatogrel dose versus placebo. The proportion of responders for each of the two doses of selatogrel was compared to placebo.~No imputation was considered for handling missing values in the main analysis."||162.3|23.1|< 0.0001
71094648|NCT03384966|141697276|OTHER|Logistic regression (Type III analysis)||||||0.1915|||||||Chi-squared|||||||0.1915
71094649|NCT03384966|141697278|OTHER||LS Mean difference with placebo|-27.49|||<|0.0001|TWO_SIDED|95.0|-35.4|-19.6|||Mixed Models Analysis|P-value significance level is set to 0.025, i.e. type I error (0.05) adjusted for multiplicity (2 comparisons) using a Bonferroni approach.||Longitudinal analysis of the treatment effect, from start of treatment to 8 hours after injection.||-19.6|-35.4|<.0001
71094650|NCT03384966|141697278|OTHER||LS Mean difference with placebo|-31.06|||<|0.0001|TWO_SIDED|95.0|-39.0|-23.1|||Mixed Models Analysis|P-value significance level is set to 0.025, i.e. type I error (0.05) adjusted for multiplicity (2 comparisons) using a Bonferroni approach||Longitudinal analysis of the treatment effect, from start of treatment up to 8 hours after injection.||-23.1|-39.0|<.0001
71094651|NCT02202616|141697281|OTHER||Mean Difference (Final Values)|0.17|STANDARD_DEVIATION|0.34|||TWO_SIDED|95.0|0.14|0.21|||Descriptive Statistics with 95% CI|The mean change from baseline along with the 95% confidence interval used to assess the precision of the estimate||||0.21|0.14|
70920433|NCT00212134|141331358|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
71032342|NCT02601560|141573432|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
71094652|NCT02202616|141697282|OTHER||Mean Difference (Final Values)|0.14|STANDARD_DEVIATION|0.278|||TWO_SIDED|95.0|0.11|0.17|||Descriptive Statistics with 95% CI|The mean change from baseline along with the 95% confidence interval used to assess the precision of the estimate||||0.17|0.11|
71094653|NCT02202616|141697283|OTHER||Mean Difference (Final Values)|2.0|STANDARD_DEVIATION|2.47|||TWO_SIDED|95.0|1.74|2.3|||Standard Descriptive Statistics|The estimated mean change from baseline and corresponding 95% confidence intervals will be displayed for each visit.||Week 4||2.30|1.74|
71094654|NCT02202616|141697283|OTHER||Mean Difference (Final Values)|2.5|STANDARD_DEVIATION|2.92|||TWO_SIDED|95.0|2.21|2.85|||Standard Descriptive Statistics|The estimated mean change from baseline and corresponding 95% confidence intervals will be displayed for each visit||Week 16||2.85|2.21|
71094655|NCT02202616|141697284|OTHER||Mean Difference (Final Values)|-5.0|STANDARD_DEVIATION|6.25|||TWO_SIDED|95.0|-5.7|-4.3|||standard descriptive statistics|The estimated mean change from baseline to Week 4 along with the 95% confidence interval||Week 4||-4.3|-5.7|
70920434|NCT00212134|141331359|OTHER|||||||0.82|||||||Chi-squared|||||||0.82
70920435|NCT00212134|141331360|SUPERIORITY|||||||0.03|||||||Fisher Exact|||||||0.03
70920436|NCT00212134|141331361|SUPERIORITY|||||||0.008|||||||Fisher Exact|||||||0.008
70920437|NCT00212134|141331362|SUPERIORITY||Mean Difference (Final Values)|15.7|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||ITT analyses comparing parents of children randomized to receive an IOL to those left aphakic.||||<0.05
71032343|NCT02601560|141573432|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
71032344|NCT02601560|141573432|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
71032345|NCT02601560|141573432|SUPERIORITY_OR_OTHER|||||||0.44|||||||ANCOVA|||||||0.440
71032346|NCT02601560|141573432|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
70973197|NCT02889796|141453166|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-12.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-12.0|<0.001
70973198|NCT02889796|141453168|SUPERIORITY||Least Squares Mean Difference|-10.83|STANDARD_ERROR_OF_MEAN|0.952|<|0.001|TWO_SIDED|95.0|-12.7|-8.96||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.96|-12.70|<0.001
70973199|NCT02889796|141453168|SUPERIORITY||Least Squares Mean Difference|-7.73|STANDARD_ERROR_OF_MEAN|0.947|<|0.001|TWO_SIDED|95.0|-9.58|-5.87||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.87|-9.58|<0.001
70973200|NCT02889796|141453168|SUPERIORITY||Least Squares Mean Difference|-9.39|STANDARD_ERROR_OF_MEAN|0.989|<|0.001|TWO_SIDED|95.0|-11.33|-7.45||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.45|-11.33|<0.001
70973201|NCT02889796|141453168|SUPERIORITY||Least Squares Mean Difference|-7.35|STANDARD_ERROR_OF_MEAN|0.987|<|0.001|TWO_SIDED|95.0|-9.29|-5.42||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.42|-9.29|<0.001
70973202|NCT02889796|141453168|SUPERIORITY||Least Squares Mean Difference|-8.02|STANDARD_ERROR_OF_MEAN|0.961|<|0.001|TWO_SIDED|95.0|-9.9|-6.13||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.13|-9.90|<0.001
70973203|NCT02889796|141453168|SUPERIORITY||Least Squares Mean Difference|-6.46|STANDARD_ERROR_OF_MEAN|0.96|<|0.001|TWO_SIDED|95.0|-8.35|-4.58||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.58|-8.35|<0.001
70973204|NCT02889796|141453168|SUPERIORITY||Least Squares Mean Difference|-7.91|STANDARD_ERROR_OF_MEAN|1.007|<|0.001|TWO_SIDED|95.0|-9.88|-5.93||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.93|-9.88|<0.001
70973205|NCT02889796|141453168|SUPERIORITY||Least Squares Mean Difference|-6.59|STANDARD_ERROR_OF_MEAN|1.005|<|0.001|TWO_SIDED|95.0|-8.56|-4.62||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.62|-8.56|<0.001
70973206|NCT02889796|141453170|SUPERIORITY||Difference in Response Rates|12.3|||<|0.001|TWO_SIDED|95.0|5.7|18.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 2.||18.9|5.7|<0.001
70973207|NCT02889796|141453170|SUPERIORITY||Difference in Response Rates|6.5||||0.043|TWO_SIDED|95.0|-0.1|13.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 2.||13.1|-0.1|0.043
70973208|NCT02889796|141453170|SUPERIORITY||Difference in Response Rates|16.3|||<|0.001|TWO_SIDED|95.0|9.8|22.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4.||22.8|9.8|<0.001
70973209|NCT02889796|141453170|SUPERIORITY||Difference in Response Rates|8.1||||0.011|TWO_SIDED|95.0|1.5|14.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4.||14.7|1.5|0.011
70973210|NCT02889796|141453170|SUPERIORITY||Difference in Response Rates|21.0|||<|0.001|TWO_SIDED|95.0|14.9|27.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12.||27.0|14.9|<0.001
70973211|NCT02889796|141453170|SUPERIORITY||Difference in Response Rates|13.6|||<|0.001|TWO_SIDED|95.0|7.3|19.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12.||19.9|7.3|<0.001
70973212|NCT02889796|141453170|SUPERIORITY||Difference in Response Rates|16.6|||<|0.001|TWO_SIDED|95.0|10.5|22.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24.||22.8|10.5|<0.001
70973213|NCT02889796|141453170|SUPERIORITY||Difference in Response Rates|14.1|||<|0.001|TWO_SIDED|95.0|7.8|20.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24.||20.3|7.8|<0.001
70973214|NCT02889796|141453172|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.9|-0.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.6|-0.9|<0.001
70973215|NCT02889796|141453172|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.5|-0.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.3|-0.5|<0.001
70973216|NCT02889796|141453172|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.9|-0.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.7|-0.9|<0.001
70973217|NCT02889796|141453172|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.7|-0.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.4|-0.7|<0.001
70973218|NCT02889796|141453172|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-1.1|-0.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.8|-1.1|<0.001
70973219|NCT02889796|141453172|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.8|-0.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.5|-0.8|<0.001
70973220|NCT02889796|141453172|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-1.1|-0.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.8|-1.1|<0.001
70973221|NCT02889796|141453172|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.8|-0.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.5|-0.8|<0.001
70973222|NCT02889796|141453174|SUPERIORITY||Difference in Response Rates|9.5|||<|0.001|TWO_SIDED|95.0|5.8|13.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 2||13.1|5.8|<0.001
70973223|NCT02889796|141453174|SUPERIORITY||Difference in Response Rates|4.5||||0.004|TWO_SIDED|95.0|1.4|7.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 2||7.7|1.4|0.004
70973224|NCT02889796|141453174|SUPERIORITY||Difference in Response Rates|16.2|||<|0.001|TWO_SIDED|95.0|11.3|21.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||21.1|11.3|<0.001
70973225|NCT02889796|141453174|SUPERIORITY||Difference in Response Rates|11.2|||<|0.001|TWO_SIDED|95.0|6.5|15.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||15.8|6.5|<0.001
70973226|NCT02889796|141453174|SUPERIORITY||Difference in Response Rates|26.9|||<|0.001|TWO_SIDED|95.0|20.6|33.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||33.3|20.6|<0.001
70973227|NCT02889796|141453174|SUPERIORITY||Difference in Response Rates|19.4|||<|0.001|TWO_SIDED|95.0|13.1|25.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||25.8|13.1|<0.001
70973228|NCT02889796|141453176|SUPERIORITY||Difference in Response Rates|4.4|||<|0.001|TWO_SIDED|95.0|2.1|6.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 2.||6.7|2.1|<0.001
70973229|NCT02889796|141453176|SUPERIORITY||Difference in Response Rates|1.0||||0.17|TWO_SIDED|95.0|-0.5|2.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 2.||2.6|-0.5|0.17
71094656|NCT02202616|141697284|OTHER||Mean Difference (Final Values)|-6.5|STANDARD_DEVIATION|7.03|||TWO_SIDED|95.0|-7.3|-5.7|||standard descriptive statistics|The estimated mean change from baseline to Week 4 along with the 95% confidence interval||Week 16||-5.7|-7.3|
71094657|NCT01119222|141697301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|2.45|||TWO_SIDED|90.0|-3.82|4.38|||Mixed Models Analysis|||Pre-dose; mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual. Sample sizing calculated based on results from previous methodology studies performed using the same cold pain test; primary criteria was ability to detect a significant gabapentin effect over placebo.||4.38|-3.82|
71094658|NCT01119222|141697301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|2.45|||TWO_SIDED|90.0|-3.53|4.68|||Mixed Models Analysis|||Pre-dose; mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||4.68|-3.53|
71094659|NCT01119222|141697301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|2.45|||TWO_SIDED|90.0|-3.99|4.22|||Mixed Models Analysis|||Pre-dose; mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||4.22|-3.99|
71094660|NCT01119222|141697301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.14|STANDARD_ERROR_OF_MEAN|1.97|||TWO_SIDED|90.0|-1.15|5.44|||Mixed Models Analysis|||1 hour post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||5.44|-1.15|
71094661|NCT01119222|141697301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.18|STANDARD_ERROR_OF_MEAN|1.97|||TWO_SIDED|90.0|-14.48|-7.89|||Mixed Models Analysis|||1 hour post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||-7.89|-14.48|
71094662|NCT01119222|141697301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.49|STANDARD_ERROR_OF_MEAN|1.96|||TWO_SIDED|90.0|2.2|8.78|||Mixed Models Analysis|||1 hour post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||8.78|2.20|
71094663|NCT01119222|141697301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|2.87|||TWO_SIDED|90.0|-5.53|4.08|||Mixed Models Analysis|||1.5 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||4.08|-5.53|
71094664|NCT01119222|141697301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.93|STANDARD_ERROR_OF_MEAN|2.87|||TWO_SIDED|90.0|-18.74|-9.13|||Mixed Models Analysis|||1.5 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||-9.13|-18.74|
71094665|NCT01119222|141697301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.88|STANDARD_ERROR_OF_MEAN|2.92|||TWO_SIDED|90.0|-2.01|7.78|||Mixed Models Analysis|||1.5 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||7.78|-2.01|
71094666|NCT01119222|141697301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|STANDARD_ERROR_OF_MEAN|3.66|||TWO_SIDED|90.0|-5.32|6.96|||Mixed Models Analysis|||2 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||6.96|-5.32|
71094667|NCT01119222|141697301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.12|STANDARD_ERROR_OF_MEAN|3.59|||TWO_SIDED|90.0|-19.14|-7.09|||Mixed Models Analysis|||2 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||-7.09|-19.14|
71094668|NCT01119222|141697301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.58|STANDARD_ERROR_OF_MEAN|3.59|||TWO_SIDED|90.0|-4.45|7.6|||Mixed Models Analysis|||2 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||7.60|-4.45|
71094669|NCT01119222|141697301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.53|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|90.0|-7.39|2.32||||||4 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||2.32|-7.39|
71094670|NCT01119222|141697301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.59|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|90.0|-14.44|-4.73|||Mixed Models Analysis|||4 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||-4.73|-14.44|
71094671|NCT01119222|141697301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|90.0|-4.85|4.85|||Mixed Models Analysis|||4 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||4.85|-4.85|
70920438|NCT00212134|141331364|SUPERIORITY||Mean Difference (Final Values)|7.295|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||ITT comparison of mean PSI scores||||>0.05
70920439|NCT02409667|141331365|NON_INFERIORITY|The statistical null-hypothesis to be rejected in the primary analysis was that the odds ratio of maintaining a PASI 90 response for patients with secukinumab 4-weekly dosing versus patients on secukinumab 6-weekly dosing exceeds the non-inferiority margin of 1+δ.|Odds Ratio (OR)|1.91||||0.1499|TWO_SIDED|95.0|1.44|2.55|||Regression, Logistic|||||2.55|1.44|0.1499
70920440|NCT02409667|141331366|SUPERIORITY||Odds Ratio (OR)|0.62||||0.1013|TWO_SIDED|95.0|0.35|1.1|||Regression, Logistic|||||1.10|0.35|0.1013
70920441|NCT02409667|141331369|SUPERIORITY||Least square mean (LSM) estimate|-0.09||||0.0489|TWO_SIDED|95.0|-0.18|0.0|||ANCOVA|||Week 28||-0.00|-0.18|0.0489
70920442|NCT02409667|141331369|SUPERIORITY||LSM estimate|-0.09||||0.1073|TWO_SIDED|95.0|-0.19|0.02|||ANCOVA|||Week 32||0.02|-0.19|0.1073
70920443|NCT02409667|141331369|SUPERIORITY||LSM estimate|-0.24||||0.0001|TWO_SIDED|95.0|-0.37|-0.12|||ANCOVA|||Week 36||-0.12|-0.37|0.0001
70920444|NCT02409667|141331369|SUPERIORITY||LSM estimate|-0.25||||0.0005|TWO_SIDED|95.0|-0.38|-0.11|||ANCOVA|||Week 40||-0.11|-0.38|0.0005
70920445|NCT02409667|141331369|SUPERIORITY||LSM estimate|-0.3||||0.0001|TWO_SIDED|95.0|-0.45|-0.15|||ANCOVA|||Week 44||-0.15|-0.45|0.0001
70920446|NCT02409667|141331369|SUPERIORITY||LSM estimate|-0.49||||0|TWO_SIDED|95.0|-0.7|-0.27|||ANCOVA|||Week 48||-0.27|-0.70|0.0000
70920447|NCT02409667|141331369|SUPERIORITY||LSM mean|-0.59||||0|TWO_SIDED|95.0|-0.81|-0.36|||ANCOVA|||||-0.36|-0.81|0.0000
70920448|NCT02409667|141331370|SUPERIORITY||LSM estimate|0.4||||0.174|TWO_SIDED|95.0|-0.18|0.99|||ANCOVA|||Week 28||0.99|-0.18|0.1740
71032347|NCT00440297|141573468|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|48.5||||||95.0|38.4|58.7|||||Exact binomial confidence interval.|No hypothesis is being tested. The purpose of the primary analysis is to estimate the seroprotection rate (percentage of subjects with anti-HBs \>=10mIU/mL) in each group at 1 month after the third dose among subjects who were seronegative at baseline||58.7|38.4|
70920449|NCT02409667|141331370|SUPERIORITY||LSM estimate|0.79||||0.0287|TWO_SIDED|95.0|0.08|1.5|||ANCOVA|||Week 32||1.50|0.08|0.0287
70920450|NCT02409667|141331370|SUPERIORITY||LSM estimate|0.62||||0.1202|TWO_SIDED|95.0|-0.16|1.41|||ANCOVA|||Week 36||1.41|-0.16|0.1202
70920451|NCT02409667|141331370|SUPERIORITY||LSM estimate|0.75||||0.1157|TWO_SIDED|95.0|-0.19|1.68|||ANCOVA|||Week 40||1.68|-0.19|0.1157
70920452|NCT02409667|141331370|SUPERIORITY||LSM estimate|0.54||||0.3189|TWO_SIDED|95.0|-0.52|1.59|||ANCOVA|||Week 44||1.59|-0.52|0.3189
70920453|NCT02409667|141331370|SUPERIORITY||LSM estimate|1.17||||0.024|TWO_SIDED|95.0|0.16|2.18|||ANCOVA|||Week 48||2.18|0.16|0.0240
70920454|NCT02409667|141331370|SUPERIORITY||LSM estimate|1.47||||0.009|TWO_SIDED|95.0|0.37|2.57|||ANCOVA|||Week 52||2.57|0.37|0.0090
70920455|NCT02409667|141331371|SUPERIORITY||LSM estimate|-0.62||||0.0001|TWO_SIDED|95.0|-0.93|-0.31|||ANCOVA|||||-0.31|-0.93|0.0001
70920456|NCT02409667|141331372|SUPERIORITY||LSM estimate|1.17||||0.0675|TWO_SIDED|95.0|-0.09|2.42|||ANCOVA|||||2.42|-0.09|0.0675
70920457|NCT02409667|141331373|SUPERIORITY||LSM estimate|-0.97||||0.2101|TWO_SIDED|95.0|-2.48|0.55|||ANCOVA|||Absenteeism||0.55|-2.48|0.2101
70920458|NCT02409667|141331373|SUPERIORITY||LSM estimate|-0.67||||0.2971|TWO_SIDED|95.0|-1.93|0.59|||ANCOVA|||Presenteeism||0.59|-1.93|0.2971
70920459|NCT02409667|141331373|SUPERIORITY||LSM estimate|-0.61||||0.5499|TWO_SIDED|95.0|-2.59|1.38|||ANCOVA|||Total activity impairment||1.38|-2.59|0.5499
70920460|NCT02409667|141331373|SUPERIORITY||LSM estimate|-1.08||||0.0758|TWO_SIDED|95.0|-2.28|0.11|||ANCOVA|||||0.11|-2.28|0.0758
70920461|NCT02409667|141331374|SUPERIORITY||LSM estimate|1.2||||0.4156|TWO_SIDED|95.0|-1.71|4.11|||ANCOVA|||Absenteeism||4.11|-1.71|0.4156
70920462|NCT02409667|141331374|SUPERIORITY||LSM estimate|0.63||||0.8619|TWO_SIDED|95.0|-6.59|7.85|||ANCOVA|||Presenteeism||7.85|-6.59|0.8619
70920463|NCT02409667|141331374|SUPERIORITY||LSM estimate|-0.61||||0.6139|TWO_SIDED|95.0|-6.31|10.61|||ANCOVA|||Total activity impairment||10.61|-6.31|0.6139
70920464|NCT02409667|141331374|SUPERIORITY||LSM estimate|1.7||||0.5674|TWO_SIDED|95.0|-4.16|7.56|||ANCOVA|||Work productivity loss||7.56|-4.16|0.5674
70920465|NCT02409667|141331375|SUPERIORITY||LSM estimate|-0.13||||0.1219|TWO_SIDED|95.0|-0.3|0.04|||ANCOVA|||Pain||0.04|-0.30|0.1219
70920466|NCT02409667|141331375|SUPERIORITY||LSM estimate|-0.38||||0.0001|TWO_SIDED|95.0|-0.57|-0.18|||ANCOVA|||Itching||-0.18|-0.57|0.0001
70920467|NCT02409667|141331375|SUPERIORITY||LSM estimate|-0.31||||0.0003|TWO_SIDED|95.0|-0.48|-0.14|||ANCOVA|||Scaling||-0.14|-0.48|0.0003
70920468|NCT02409667|141331376|SUPERIORITY||LSM estimate|0.17||||0.6457|TWO_SIDED|95.0|-0.57|0.92|||ANCOVA|||Pain||0.92|-0.57|0.6457
70920469|NCT02409667|141331376|SUPERIORITY||LSM estimate|0.19||||0.6136|TWO_SIDED|95.0|-0.56|0.94|||ANCOVA|||Itching||0.94|-0.56|0.6136
70920470|NCT02409667|141331376|SUPERIORITY||LSM estimate|0.75||||0.0203|TWO_SIDED|95.0|0.12|1.39|||ANCOVA|||Scaling||1.39|0.12|0.0203
70920471|NCT02409667|141331377|SUPERIORITY||LSM estimate|2.22||||0.0027|TWO_SIDED|95.0|0.77|3.68|||ANCOVA|||||3.68|0.77|0.0027
70920472|NCT02409667|141331378|SUPERIORITY||LSM estimate|-2.31||||0.2823|TWO_SIDED|95.0|-6.55|1.92|||ANCOVA|||||1.92|-6.55|0.2823
70920473|NCT02409667|141331379|SUPERIORITY||LSM estimate|0.01||||0.0861|TWO_SIDED|95.0|0.0|0.02|||ANCOVA|||Germany||0.02|-0.00|0.0861
70920474|NCT02409667|141331379|SUPERIORITY||LSM estimate|0.02||||0.0117|TWO_SIDED|95.0|0.0|0.04|||ANCOVA|||UK||0.04|0.00|0.0117
70920475|NCT02409667|141331380|SUPERIORITY||LSM estimate|-0.02||||0.1852|TWO_SIDED|95.0|-0.05|0.01|||ANCOVA|||Germany||0.01|-0.05|0.1852
70920476|NCT02409667|141331380|SUPERIORITY||LSM estimate|-0.03||||0.2203|TWO_SIDED|95.0|-0.07|0.02|||ANCOVA|||UK||0.02|-0.07|0.2203
70920477|NCT04188379|141331421|SUPERIORITY||Odds Ratio (OR)|4.884||||0.0316|TWO_SIDED|95.0|1.007|43.591|||Cochran-Mantel-Haenszel|||||43.591|1.007|0.0316
70920478|NCT04188379|141331422|SUPERIORITY||Median Difference (Net)|1.0||||0.0009|TWO_SIDED|95.0|0.0|4.0|||Wilcoxon (Mann-Whitney)|||||4.000|0.000|0.0009
70920479|NCT04188379|141331423|SUPERIORITY||Odds Ratio (OR)|5.224||||0.0108|TWO_SIDED|95.0|1.268|26.268|||Cochran-Mantel-Haenszel|||||26.268|1.268|0.0108
70920480|NCT04188379|141331424|SUPERIORITY||Rate Ratio|0.958||||0.8287|TWO_SIDED|95.0|0.651|1.41|||Wald Test|||||1.41|0.651|0.8287
70920481|NCT04188379|141331425|SUPERIORITY||Odds Ratio (OR)|4.354||||0.0265|TWO_SIDED|95.0|1.048|22.865|||Cochran-Mantel-Haenszel|||||22.865|1.0480|0.0265
70920482|NCT02566902|141331428|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
70920483|NCT02566902|141331429|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
70920484|NCT02566902|141331430|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
70920485|NCT02566902|141331431|SUPERIORITY|||||||0.96|||||||Chi-squared|||||||0.96
70920486|NCT02566902|141331432|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||||||0.99
70920487|NCT02566902|141331433|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
70920488|NCT03112174|141331442|SUPERIORITY||Hazard Ratio (HR)|0.629||||0.0024|TWO_SIDED|95.0|0.465|0.85||P value is from stratified log-rank test.|Log Rank|||||0.850|0.465|0.0024
70920489|NCT03112174|141331448|SUPERIORITY||Rate Ratio|1.658||||0.0004|TWO_SIDED|95.0|1.24|2.218||Estimate and p-value for rate ratio are based on Cochran-Mantel-Haenszel (CMH) test adjusted for two randomization stratification factors: number of prior lines of therapy (1-2 vs \>=3) and TLS category (low risk vs increased risk) at randomization.|Cochran-Mantel-Haenszel||For rate ratio, numerator is Ibrutinib + Venetoclax arm and denominator is Ibrutinib + Placebo arm.|||2.218|1.240|0.0004
70920490|NCT03112174|141331449|SUPERIORITY||Rate Ratio|1.101||||0.1279|TWO_SIDED|95.0|0.973|1.247||Estimate and p-value for rate ratio are based on CMH test adjusted for two randomization stratification factors: number of prior lines of therapy (1-2 vs \>=3) and TLS category (low risk vs increased risk) at randomization.|Cochran-Mantel-Haenszel||For rate ratio, numerator is Ibrutinib + Venetoclax arm and denominator is Ibrutinib + Placebo arm.|||1.247|0.973|0.1279
70920491|NCT03112174|141331450|SUPERIORITY|||||||0.2028|||||||Fisher Exact|||Bone marrow aspirate||||0.2028
70920492|NCT03112174|141331450|SUPERIORITY|||||||0.0014|||||||Fisher Exact|||Peripheral blood||||0.0014
71032348|NCT00440297|141573468|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|57.7||||||95.0|47.9|67.0|||||Exact binomial confidence interval.|||67.0|47.9|
71032349|NCT00440297|141573469|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|66.7||||||95.0|56.5|75.8|||||Exact binomial confidence interval|||75.8|56.5|
71032350|NCT00440297|141573469|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|69.2||||||95.0|59.4|77.9|||||Exact binomial confidence interval|||77.9|59.4|
71032351|NCT02934347|141573473|SUPERIORITY_OR_OTHER||||||>|0.05||||||Grades analysed were 1, 2 and then 3 and 4 combined because of low frequencies in the latter two grades|Chi-squared, Corrected|Chi-squared for trend||Null hypothesis: no difference in frequency of grade of glottic view between the supine and back-up positions||||>0.05
71032352|NCT02934347|141573474|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Chi-squared|df=3||||||<0.01
71032353|NCT02934347|141573475|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
71032354|NCT02934347|141573476|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71032355|NCT00834535|141573522|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.83||||||90.0|93.98|108.17|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.17|93.98|
71032356|NCT00834535|141573523|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.1||||||90.0|92.14|100.22|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.22|92.14|
71032357|NCT00834535|141573524|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.57||||||90.0|92.8|100.49|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.49|92.8|
71032358|NCT02055963|141573534|OTHER|||||||0.98|||||||Wilcoxon Rank Sum Test|||||||0.98
71032359|NCT01819597|141573544|OTHER|This is a phase II study design to determine the non-futility of proceeding to a phase III pivotal evaluation. The study group was planned to be compared to a propensity score matching (PSM) cohort from to the patients in the medical arms of the SAMMPRIS trial and to patients in the medical arm of COSS that had demonstrated angiographic intracranial atherosclerosis and occlusion.|Hazard Ratio (HR)|0.38||||0.08|TWO_SIDED|90.0|0.14|0.94||Pre-established α ≤ 0.10 for phase IIa|Regression, Cox|Alpha set at ≤ 0.1. for phase II study|ERSIAS/ Controls.|We derived the sample size required to power the trial to test the difference between two binomial event rates using the method of Farrington and Manning as implemented in R package gsDesign (Anderson, 2011). An estimated sample size of 52 patients will be necessary to detect a ∆ of 0.05, with a one-sided alpha of 0.10 and a beta of 0.10 - acceptable parameters for a non-definitive, non-futility study (Palesch et al., 2005, Levin, 2005).||0.94|0.14|0.08
71032360|NCT02495857|141573551|SUPERIORITY||Mean Difference (Net)|36.18|||||TWO_SIDED|95.0|10.25|62.11||||||||62.11|10.25|
71032361|NCT02495857|141573552|SUPERIORITY||Mean Difference (Net)|36.19|||||TWO_SIDED|95.0|10.25|62.11||||||||62.11|10.25|
71032362|NCT02495857|141573553|EQUIVALENCE|From baseline to week 26 visit, change in the WOMAC stiffness score was evaluated.|Mean Difference (Net)|5.63|||||TWO_SIDED|95.0|-13.61|8.49||||||||8.49|-13.61|
71032363|NCT04605094|141573558|OTHER||Difference in response rate|-8.62||||0.08|TWO_SIDED|95.0|-17.94|0.71|||Regression, Logistic|||"Treatment difference in IGA responders~Estimates were from a logistic regression model that included treatment group, age as recorded on electronic case report form (eCRF) at screening (\>=12 to \<18 years; \>=18 years), blood eosinophils as recorded on eCRF at screening (\<300 cells/microliters \[μL\]; \>=300 cells/μL) and baseline value of IGA score."||0.71|-17.94|0.080
71032364|NCT04605094|141573559|OTHER||Difference in response rate|-5.15||||0.384|TWO_SIDED|95.0|-16.67|6.36|||Regression, Logistic|||"Treatment difference in EASI-75 responders~Estimates were from a logistic regression model that included treatment group, age as recorded on eCRF at screening (\>=12 to \< 18 years; \>=18 years), blood eosinophils as recorded on eCRF at screening (\<300 cells/μL; \>=300 cells/μL) and baseline EASI total score."||6.36|-16.67|0.384
71032365|NCT04605094|141573560|OTHER||Difference in response rate|-8.18||||0.078|TWO_SIDED|95.0|-16.94|0.59|||Regression, Logistic|||"Treatment difference in EASI-90 responders~Estimates were from a logistic regression model that included treatment group, age as recorded on eCRF at screening (\>=12 to \< 18 years; \>=18 years), blood eosinophils as recorded on eCRF at screening (\<300 cells/μL; \>=300 cells/μL) and baseline EASI total score."||0.59|-16.94|0.078
71032366|NCT04605094|141573561|OTHER||Difference in response rate|0.69||||0.889|TWO_SIDED|95.0|-8.93|10.32|||Regression, Logistic|||"Treatment difference in Peak Pruritus NRS~Estimates were from a logistic regression model that included treatment group, age as recorded on eCRF at screening (\>=12 to \< 18 years; \>=18 years), blood eosinophils as recorded on eCRF at screening (\<300 cells/μL; \>=300 cells/μL) and baseline Peak Pruritus score."||10.32|-8.93|0.889
71032367|NCT02724462|141573562|SUPERIORITY||Odds Ratio (OR)|1.49|||<|0.001|TWO_SIDED|95.0|1.22|1.83|||Regression, Logistic|||||1.83|1.22|<.001
71032368|NCT02724462|141573563|SUPERIORITY||Odds Ratio (OR)|1.4||||0.001|TWO_SIDED|95.0|1.14|1.71|||Regression, Logistic|||||1.71|1.14|.001
71032369|NCT01969747|141573582|SUPERIORITY_OR_OTHER||Adjusted mean|76.09|STANDARD_ERROR_OF_MEAN|8.77|<|0.0001|TWO_SIDED|95.0|58.6|93.59|||ANCOVA||The model includes baseline UGE as linear covariate(s) and treatment as fixed effect(s).|Comparison of Empagliflozin 2.5 mg with Placebo||93.59|58.60|<0.0001
71032370|NCT01969747|141573582|SUPERIORITY_OR_OTHER||Adjusted mean|106.39|STANDARD_ERROR_OF_MEAN|8.85|<|0.0001|TWO_SIDED|95.0|88.73|124.05|||ANCOVA||The model includes baseline UGE as linear covariate(s) and treatment as fixed effect(s).|Comparison of Empagliflozin 10 mg with Placebo||124.05|88.73|<0.0001
70973230|NCT02889796|141453176|SUPERIORITY||Difference in Response Rates|10.7|||<|0.001|TWO_SIDED|95.0|7.1|14.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4.||14.4|7.1|<0.001
70973231|NCT02889796|141453176|SUPERIORITY||Difference in Response Rates|5.8|||<|0.001|TWO_SIDED|95.0|2.6|9.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4.||9.0|2.6|<0.001
70973232|NCT02889796|141453176|SUPERIORITY||Difference in Response Rates|32.2|||<|0.001|TWO_SIDED|95.0|26.4|38.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24.||38.0|26.4|<0.001
70973233|NCT02889796|141453176|SUPERIORITY||Difference in Response Rates|19.0|||<|0.001|TWO_SIDED|95.0|13.4|24.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24.||24.6|13.4|<0.001
70973234|NCT02889796|141453176|SUPERIORITY||Difference in Response Rates|12.7|||<|0.001|TWO_SIDED|95.0|5.6|19.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Adalimumab at Week 24.||19.9|5.6|<0.001
70973235|NCT02889796|141453176|SUPERIORITY||Difference in Response Rates|-0.5||||0.88|TWO_SIDED|95.0|-7.5|6.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Adalimumab at Week 24.||6.5|-7.5|0.88
70973236|NCT02889796|141453176|NON_INFERIORITY|For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) \< 2.6 at using NRI.|||||<|0.001||||||P-value of non-inferiority test was calculated from approach proposed by \[Liu 2014\].|Method proposed by [Liu 2014]|||Filgotinib 200 mg vs Adalimumab at Week 24.||||<0.001
70973237|NCT02889796|141453176|NON_INFERIORITY|For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) \< 2.6 at using NRI.|||||<|0.001||||||P-value of non-inferiority test was calculated from approach proposed by \[Liu 2014\].|Method proposed by [Liu 2014]|||Filgotinib 100 mg vs Adalimumab at Week 24.||||<0.001
70973238|NCT02889796|141453182|SUPERIORITY||Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|0.68|<|0.001|TWO_SIDED|95.0|-5.9|-3.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.2|-5.9|<0.001
70973239|NCT02889796|141453182|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.68|<|0.001|TWO_SIDED|95.0|-4.3|-1.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.6|-4.3|<0.001
70973240|NCT02889796|141453182|SUPERIORITY||Least Squares Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|0.73|<|0.001|TWO_SIDED|95.0|-6.6|-3.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.8|-6.6|<0.001
70973241|NCT02889796|141453182|SUPERIORITY||Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|0.73|<|0.001|TWO_SIDED|95.0|-5.3|-2.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.4|-5.3|<0.001
70973242|NCT02889796|141453182|SUPERIORITY||Least Squares Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|0.69|<|0.001|TWO_SIDED|95.0|-7.3|-4.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.6|-7.3|<0.001
71032371|NCT01969747|141573582|SUPERIORITY_OR_OTHER||Adjusted mean|104.81|STANDARD_ERROR_OF_MEAN|8.99|<|0.0001|TWO_SIDED|95.0|86.88|122.74|||ANCOVA||The model includes baseline UGE as linear covariate(s) and treatment as fixed effect(s).|Comparison of Empagliflozin 25 mg with Placebo||122.74|86.88|<0.0001
71032372|NCT02393417|141573583|SUPERIORITY||Risk Ratio (RR)|1.5706||||0.0329|TWO_SIDED|95.0|1.0184|2.4223|||Cochran-Mantel-Haenszel|||||2.4223|1.0184|0.0329
71032373|NCT02393417|141573583|SUPERIORITY||Risk Ratio (RR)|1.8926||||0.0007|TWO_SIDED|95.0|1.2722|2.8156|||Cochran-Mantel-Haenszel|||||2.8156|1.2722|0.0007
71032374|NCT02393417|141573583|SUPERIORITY||Risk Ratio (RR)|1.7319||||0.0052|TWO_SIDED|95.0|1.1602|2.5854|||Cochran-Mantel-Haenszel|||||2.5854|1.1602|0.0052
71032375|NCT02393417|141573584|SUPERIORITY||Risk Ratio (RR)|1.3828||||0.4307|TWO_SIDED|95.0|0.6191|3.0883|||Cochran-Mantel-Haenszel|||||3.0883|0.6191|0.4307
70973243|NCT02889796|141453182|SUPERIORITY||Least Squares Mean Difference|-4.4|STANDARD_DEVIATION|0.69|<|0.001|TWO_SIDED|95.0|-5.8|-3.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.1|-5.8|<0.001
71032376|NCT02393417|141573584|SUPERIORITY||Risk Ratio (RR)|2.8908||||0.0014|TWO_SIDED|95.0|1.4169|5.8978|||Cochran-Mantel-Haenszel|||||5.8978|1.4169|0.0014
71032377|NCT02393417|141573584|SUPERIORITY||Risk Ratio (RR)|3.0||||0.0451|TWO_SIDED|95.0|0.9281|9.6975|||Cochran-Mantel-Haenszel|||||9.6975|0.9281|0.0451
70920493|NCT03112174|141331451|SUPERIORITY||Hazard Ratio (HR)|0.832||||0.2669|TWO_SIDED|95.0|0.602|1.151||P value is from stratified log-rank test.|Log Rank||Hazard ratio is estimated using stratified Cox regression model with treatment as the only covariate.|||1.151|0.602|0.2669
71032378|NCT02393417|141573586|SUPERIORITY||Cox Proportional Hazard|2.7553||||0.0027|TWO_SIDED|95.0|1.4211|5.3419|||Regression, Cox|||||5.3419|1.4211|0.0027
70920494|NCT03112174|141331453|SUPERIORITY||Hazard Ratio (HR)|0.541||||0.0013|TWO_SIDED|95.0|0.369|0.792||P value is from stratified log-rank test.|Log Rank||Hazard ratio is estimated using stratified Cox regression model with treatment as the only covariate.|||0.792|0.369|0.0013
70920495|NCT03112174|141331468|SUPERIORITY||Hazard Ratio (HR)|1.169||||0.2861|TWO_SIDED|95.0|0.879|1.554||P value is from stratified log-rank test.|Log Rank|||||1.554|0.879|0.2861
70920496|NCT02748317|141331473|OTHER|1 group t-test no comparison group|||||=|0.219||||||P-value is not adjusted|t-test, 2 sided|||||||=0.219
70920497|NCT00802464|141331487|OTHER||Fold increase|5.21|||||TWO_SIDED|95.0|3.89|6.98||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 1 over GSK1437173A Formulation 3 Group.||6.98|3.89|
70920498|NCT00802464|141331487|OTHER||Fold increase|4.02|||||TWO_SIDED|95.0|3.0|5.4||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 2 over GSK1437173A Formulation 3 Group.||5.4|3|
70920499|NCT00802464|141331487|OTHER||Fold increase|1.3|||||TWO_SIDED|95.0|1.07|1.58||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 1 over GSK1437173A Formulation 2 Group.||1.58|1.07|
70920500|NCT00802464|141331488|OTHER||Fold increase|2.12|||||TWO_SIDED|95.0|1.67|2.69||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 1 over GSK1437173A Formulation 3 Group.||2.69|1.67|
70920501|NCT00802464|141331488|OTHER||Fold increase|1.63|||||TWO_SIDED|95.0|1.28|2.07||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 2 over GSK1437173A Formulation 3 Group.||2.07|1.28|
70920502|NCT00802464|141331488|OTHER||Fold increase|1.3|||||TWO_SIDED|95.0|1.09|1.56||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 1 over GSK1437173A Formulation 2 Group.||1.56|1.09|
70920503|NCT00802464|141331489|OTHER||Fold increase|4.72|||||TWO_SIDED|95.0|3.81|5.85||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 1 Group over GSK1437173A Formulation 3 Group.||5.85|3.81|
70920504|NCT00802464|141331489|OTHER||Fold increase|3.36|||||TWO_SIDED|95.0|2.72|4.17||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 2 Group over GSK1437173A Formulation 3 Group.||4.17|2.72|
70920505|NCT00802464|141331489|OTHER||Fold increase|1.4|||||TWO_SIDED|95.0|1.17|1.68||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 1 Group over GSK1437173A Formulation 2 Group.||1.68|1.17|
70920506|NCT00802464|141331490|OTHER||Fold increase|3.21|||||TWO_SIDED|36.0|2.64|3.9||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 1 Group over GSK1437173A Formulation 3 Group.||3.9|2.64|
70920507|NCT00802464|141331490|OTHER||Fold increase|2.44|||||TWO_SIDED|95.0|2.02|2.97||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 2 Group over GSK1437173A Formulation 3 Group.||2.97|2.02|
70920508|NCT00802464|141331490|OTHER||Fold increase|1.31|||||TWO_SIDED|95.0|1.12|1.54||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 1 Group over GSK1437173A Formulation 2 Group.||1.54|1.12|
70920509|NCT00402246|141331507|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|17.4|||<|0.001||95.0||||The a priori threshold for significance was an alpha level of 0.05.|Wilcoxon (Mann-Whitney)|||The null hypothesis is that the time from a clinical event to a clinical decision for patients followed through the remote management system is greater than and equal to that of patients receiving only in-office care.||||<0.001
70920510|NCT00402246|141331508|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.524|ONE_SIDED|95.0||1.21||Model was fit with device group (CRT-D vs. DR-ICD) as a stratifying variable.|Andersen-Gill model|An Andersen-Gill model was utilized to account for multiple hospitalization events per subject.||An Andersen-Gill proportional hazards regression model was fit to test the hypothesis that the CV hospitalization hazard rates for patients in the remote arm is equal to that of similar patients in the in-office arm.||1.21||0.524
70920511|NCT00402246|141331508|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.325|ONE_SIDED|95.0||1.43||Model was fit with device group (CRT-D vs. DR-ICD) as a stratifying variable.|Andersen-Gill model|An Andersen-Gill model was utilized to account for multiple ED visits per subject.||An Andersen-Gill proportional hazards regression model was fit to test the hypothesis that the ED hazard rates for patients in the remote arm is equal to that of similar patients in the in-office arm.||1.43||0.325
70920512|NCT00402246|141331508|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.099|ONE_SIDED|95.0||1.31||Model was fit with device group (CRT-D vs. DR-ICD) as a stratifying variable.|Andersen-Gill model|An Andersen-Gill model was utilized to account for multiple unscheduled clinic visits per subject.||An Andersen-Gill proportional hazards regression model was fit to test the hypothesis that the hazard rates of the CV unscheduled clinic or urgent care visits for patients in the remote arm is equal to that of similar patients in the in-office arm.||1.31||0.099
71032379|NCT02393417|141573586|SUPERIORITY||Cox Proportional Hazard|3.1516||||0.0008|TWO_SIDED|95.0|1.6148|6.1509|||Regression, Cox|||||6.1509|1.6148|0.0008
71032380|NCT02393417|141573586|SUPERIORITY||Cox Proportional Hazard|3.3257||||0.0003|TWO_SIDED|95.0|1.7263|6.407|||Regression, Cox|||||6.4070|1.7263|0.0003
71032381|NCT02393417|141573592|SUPERIORITY||Odds Ratio (OR)|0.999||||0.4824|TWO_SIDED|95.0|0.997|1.001|||Regression, Logistic||An odds ratio \< 1 indicates that the age of the wart is negatively correlated with positive treatment outcome and vice versa.|Using a logistic regression model for complete resolution status of largest primary injected wart (yes vs no) with wart age as a covariate.||1.001|0.997|0.4824
71032382|NCT02393417|141573592|SUPERIORITY||Odds Ratio (OR)|1.001||||0.5007|TWO_SIDED|95.0|0.998|1.004|||Regression, Logistic||An odds ratio \< 1 indicates that the age of the wart is negatively correlated with positive treatment outcome and vice versa.|Using a logistic regression model for complete resolution status of largest primary injected wart (yes vs no) with wart age as a covariate.||1.004|0.998|0.5007
71032383|NCT02393417|141573592|SUPERIORITY||Odds Ratio (OR)|0.993||||0.0219|TWO_SIDED|95.0|0.987|0.999|||Regression, Logistic||An odds ratio \< 1 indicates that the age of the wart is negatively correlated with positive treatment outcome and vice versa.|Using a logistic regression model for complete resolution status of largest primary injected wart (yes vs no) with wart age as a covariate.||0.999|0.987|0.0219
71032384|NCT02393417|141573592|SUPERIORITY||Odds Ratio (OR)|1.0||||0.8267|TWO_SIDED|95.0|0.995|1.004|||Regression, Logistic||An odds ratio \< 1 indicates that the age of the wart is negatively correlated with positive treatment outcome and vice versa.|Using a logistic regression model for complete resolution status of largest primary injected wart (yes vs no) with wart age as a covariate.||1.004|0.995|0.8267
71032385|NCT02393417|141573593|SUPERIORITY||Odds Ratio (OR)|0.964||||0.1657|TWO_SIDED|95.0|0.915|1.015|||Regression, Logistic||An odds ratio \> 1 indicates that the age of the largest primary injected wart is positively correlated with the recurrence of any resolved wart and vice versa.|Using a logistic regression model for recurrence status of any resolved wart (yes vs no) with age of the largest primary injected wart as a covariate.||1.015|0.915|0.1657
71032386|NCT02393417|141573593|SUPERIORITY||Odds Ratio (OR)|1.0||||0.8168|TWO_SIDED|95.0|0.997|1.003|||Regression, Logistic||An odds ratio \> 1 indicates that the age of the largest primary injected wart is positively correlated with the recurrence of any resolved wart and vice versa.|Using a logistic regression model for recurrence status of any resolved wart (yes vs no) with age of the largest primary injected wart as a covariate.||1.003|0.997|0.8168
71032387|NCT02393417|141573593|SUPERIORITY||Odds Ratio (OR)|0.998||||0.4183|TWO_SIDED|95.0|0.993|1.003|||Regression, Logistic||An odds ratio \> 1 indicates that the age of the largest primary injected wart is positively correlated with the recurrence of any resolved wart and vice versa.|Using a logistic regression model for recurrence status of any resolved wart (yes vs no) with age of the largest primary injected wart as a covariate.||1.003|0.993|0.4183
70973244|NCT02889796|141453182|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|-6.9|-4.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.5|-6.9|<0.001
70973245|NCT02889796|141453182|SUPERIORITY||Least Squares Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|-5.3|-2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.9|-5.3|<0.001
70973246|NCT02889796|141453184|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-7.1|-4.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.4|-7.1|<0.001
70973247|NCT02889796|141453184|SUPERIORITY||Least Squares Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-5.0|-2.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.2|-5.0|<0.001
70973248|NCT02889796|141453184|SUPERIORITY||Least Squares Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|0.75|<|0.001|TWO_SIDED|95.0|-7.6|-4.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.6|-7.6|<0.001
70973249|NCT02889796|141453184|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|0.75|<|0.001|TWO_SIDED|95.0|-6.0|-3.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.1|-6.0|<0.001
70973250|NCT02889796|141453184|SUPERIORITY||Least Squares Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|0.71|<|0.001|TWO_SIDED|95.0|-8.2|-5.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.4|-8.2|<0.001
71032388|NCT02393417|141573593|SUPERIORITY||Odds Ratio (OR)|1.001||||0.5572|TWO_SIDED|95.0|0.997|1.006|||Regression, Logistic||An odds ratio \> 1 indicates that the age of the largest primary injected wart is positively correlated with the recurrence of any resolved wart and vice versa.|Using a logistic regression model for recurrence status of any resolved wart (yes vs no) with age of the largest primary injected wart as a covariate.||1.006|0.997|0.5572
71094672|NCT01119222|141697301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|2.22|||TWO_SIDED|90.0|-3.23|4.22|||Mixed Models Analysis|||8 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||4.22|-3.23|
70973251|NCT02889796|141453184|SUPERIORITY||Least Squares Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|0.71|<|0.001|TWO_SIDED|95.0|-6.5|-3.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.7|-6.5|<0.001
70973252|NCT02889796|141453184|SUPERIORITY||Least Squares Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|-7.8|-5.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.3|-7.8|<0.001
70973253|NCT02889796|141453184|SUPERIORITY||Least Squares Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|-6.1|-3.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.5|-6.1|<0.001
70973254|NCT02889796|141453186|SUPERIORITY||Least Squares Mean Difference|-0.39||||0.042|TWO_SIDED|95.0|-0.77|-0.01||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.01|-0.77|0.042
70973255|NCT02889796|141453186|SUPERIORITY||Least Squares Mean Difference|-0.39||||0.039|TWO_SIDED|95.0|-0.77|-0.02||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.02|-0.77|0.039
70973256|NCT02889796|141453187|SUPERIORITY||Difference in non-progression rate|6.6||||0.002|TWO_SIDED|95.0|2.2|11.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24 for change in mTSS ≤ 0.5.||11.1|2.2|0.002
70973257|NCT02889796|141453187|SUPERIORITY||Difference in non-progression rate|3.9||||0.073|TWO_SIDED|95.0|-0.8|8.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24 for change in mTSS ≤ 0.5.||8.6|-0.8|0.073
71094673|NCT01119222|141697301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.47|STANDARD_ERROR_OF_MEAN|2.22|||TWO_SIDED|90.0|-11.19|-3.75|||Mixed Models Analysis|||8 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||-3.75|-11.19|
70973258|NCT02889796|141453187|SUPERIORITY||Difference in non-progression rate|7.0||||0.009|TWO_SIDED|95.0|1.5|12.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24 for change in mTSS ≤ 0.||12.5|1.5|0.009
70973259|NCT02889796|141453187|SUPERIORITY||Difference in non-progression rate|5.0||||0.061|TWO_SIDED|95.0|-0.6|10.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24 for change in mTSS ≤ 0.||10.6|-0.6|0.061
70973260|NCT02889796|141453187|SUPERIORITY||Difference in non-progression rate|5.5||||0.004|TWO_SIDED|95.0|1.6|9.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24 for change in mTSS ≤ SDC (1.36).||9.4|1.6|0.004
70973261|NCT02889796|141453187|SUPERIORITY||Difference in non-progression rate|4.7||||0.012|TWO_SIDED|95.0|0.7|8.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24 for change in mTSS ≤ SDC (1.36).||8.8|0.7|0.012
70973262|NCT02889796|141453191|SUPERIORITY||Least Squares Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|1.9|3.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.4|1.9|<0.001
70973263|NCT02889796|141453191|SUPERIORITY||Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|1.0|2.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.5|1.0|<0.001
70973264|NCT02889796|141453191|SUPERIORITY||Least Squares Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|2.1|4.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.1|2.1|<0.001
71094674|NCT01119222|141697301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|2.22|||TWO_SIDED|90.0|-3.99|3.45|||Mixed Models Analysis|||8 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||3.45|-3.99|
70973265|NCT02889796|141453191|SUPERIORITY||Least Squares Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|2.0|4.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.1|2.0|<0.001
70973266|NCT02889796|141453195|SUPERIORITY||Least Squares Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|0.9|2.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.8|0.9|<0.001
70973267|NCT02889796|141453195|SUPERIORITY||Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.48||0.002|TWO_SIDED|95.0|0.6|2.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.5|0.6|0.002
70973268|NCT02889796|141453195|SUPERIORITY||Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.52||0.006|TWO_SIDED|95.0|0.4|2.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.5|0.4|0.006
70973269|NCT02889796|141453195|SUPERIORITY||Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.52||0.001|TWO_SIDED|95.0|0.7|2.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.7|0.7|0.001
70973270|NCT02889796|141453195|SUPERIORITY||Least Squares Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.55||0.086|TWO_SIDED|95.0|-0.1|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-0.1|0.086
70973271|NCT02889796|141453195|SUPERIORITY||Least Squares Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.55||0.12|TWO_SIDED|95.0|-0.2|1.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.9|-0.2|0.12
70973272|NCT02889796|141453199|SUPERIORITY||Least Squares Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.8|3.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.8|1.8|<0.001
70973273|NCT02889796|141453199|SUPERIORITY||Least Squares Mean Difference|2.2|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.2|3.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.2|1.2|<0.001
71094675|NCT01119222|141697302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.17|||TWO_SIDED|90.0|-4.24|3.04|||Mixed Models Analysis|||||3.04|-4.24|
70973274|NCT02889796|141453199|SUPERIORITY||Least Squares Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|1.5|3.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.8|1.5|<0.001
71008731|NCT02055976|141525247|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-23.119|STANDARD_ERROR_OF_MEAN|10.461||0.015|TWO_SIDED|95.0|-43.923|-2.315|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-2.315|-43.923|0.015
71008732|NCT02055976|141525247|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.159|STANDARD_ERROR_OF_MEAN|10.535||0.054|TWO_SIDED|95.0|-38.108|3.789|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||3.789|-38.108|0.054
71008733|NCT02055976|141525247|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-24.416|STANDARD_ERROR_OF_MEAN|12.718||0.029|TWO_SIDED|95.0|-49.696|0.865|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||0.865|-49.696|0.029
71094676|NCT01119222|141697302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.43|STANDARD_ERROR_OF_MEAN|2.17|||TWO_SIDED|90.0|-13.07|-5.79|||Mixed Models Analysis|||||-5.79|-13.07|
71094677|NCT01119222|141697302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.84|STANDARD_ERROR_OF_MEAN|2.17|||TWO_SIDED|90.0|-2.8|4.48|||Mixed Models Analysis|||||4.48|-2.80|
71094678|NCT02989389|141697323|SUPERIORITY||Mean Difference (Final Values)|-11.57||||0.215|TWO_SIDED|90.0|-29.52|10.96|||Mixed Models Analysis|||Aβ 1-40||10.96|-29.52|0.215
71094679|NCT02989389|141697323|SUPERIORITY||Mean Difference (Final Values)|-60.53|||<|0.001|TWO_SIDED|90.0|-69.79|-48.43|||Mixed Models Analysis|||Aβ 1-40||-48.43|-69.79|<0.001
71094680|NCT02989389|141697323|SUPERIORITY||Mean Difference (Final Values)|-87.07|||<|0.001|TWO_SIDED|90.0|-90.21|-82.92|||Mixed Models Analysis|||Aβ 1-40||-82.92|-90.21|<0.001
70920513|NCT00402246|141331509|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||0.29|ONE_SIDED|95.0||2.56||Model was fit with device group (CRT-D vs. DR-ICD) as a stratifying variable.|Andersen-Gill model|||An Andersen-Gill proportional hazards regression model was fit to test the hypothesis that the hazard rate of transesophageal echocardiography (TEE) taken for patients in the remote arm is equal to that of similar patients in the in-office arm.||2.56||0.29
70920514|NCT00402246|141331512|SUPERIORITY_OR_OTHER||probability|0.23||||||95.0|||||Regression, Logistic|A GEE model was utilized to account for multiple events within same patient in estimating the probability of an AT/AF alert event being symptomatic.||||||
70920515|NCT00402246|141331514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|4.3||0.779|TWO_SIDED|95.0|-0.8|1.0||The a priori threshold for significance was an alpha level of 0.05.|t-test, 2 sided|||The null hypothesis is that the time from event onset to clinical decision for symptom-driven device interrogations for patients followed through the remote management system is greater than and equal to that of patients receiving only in-office care.||1.0|-0.8|0.779
70920516|NCT00402246|141331515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.0|STANDARD_DEVIATION|19.1|<|0.001|TWO_SIDED|95.0|-13.1|-6.9||The a priori threshold for significance was an alpha level of 0.05.|t-test, 2 sided|||The null hypothesis is the time from event onset to clinical decision for both device events and symptom-driven device interrogations for patients followed through the remote management system is greater than and equal to that of patients receiving only in-office care.||-6.9|-13.1|<0.001
70920517|NCT00402246|141331516|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.82||||0.002|TWO_SIDED|95.0|0.7|0.9||The a priori threshold for statistical significance was 0.05. The threshold was met, and the null hypothesis was rejected.|negative binomial model|||The null hypothesis was that the mean LOS per hospitalization visit for patients in the remote arm was equal to that for similar patients in the in-office arm.||0.9|0.7|0.002
70920518|NCT00402246|141331517|SUPERIORITY_OR_OTHER||compliance rate|0.761|||||ONE_SIDED|95.0|0.737||||Binomial Exact Test|||3-month compliance rate|||0.737|
70920519|NCT00402246|141331517|SUPERIORITY_OR_OTHER||compliance rate|0.815|||||ONE_SIDED|95.0|0.793||||Binomial Exact Test|||6-month compliance rate|||0.793|
70920520|NCT00402246|141331517|SUPERIORITY_OR_OTHER||compliance rate|0.815|||||ONE_SIDED|95.0|0.792||||Binomial Exact Test|||9-month compliance rate|||0.792|
70920521|NCT00402246|141331517|SUPERIORITY_OR_OTHER||compliance rate|0.814|||||ONE_SIDED|95.0|0.79||||Binomial Exact Test|||12-month compliance rate|||0.79|
70920522|NCT00402246|141331519|SUPERIORITY_OR_OTHER|||||||0.217||95.0||||The a prior threshold for statistical significance was 0.05.|Mixed Models Analysis|Model was fit with randomization arm, device group (CRT-D vs. DR-ICD), and follow-up visit as fixed effects, and subject as a random effect.||A mixed model was fit to test whether patients followed through the remote management system will experience less anxiety than patients followed through in-office care.||||0.217
70920523|NCT00402246|141331520|SUPERIORITY_OR_OTHER|||||||0.154||95.0||||The a priori threshold for statistical significance for was 0.05.|Mixed Models Analysis|Model was fit with randomization arm, device group (CRT-D vs. DR-ICD), and follow-up visit as fixed effects, and subject as a random effect.||A mixed model was fit to test whether patients followed through the remote management system will experience less anxiety than patients followed through in-office care.||||0.154
70920524|NCT01808339|141331553|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.077|||||TWO_SIDED|90.0|0.001|0.152|||||The estimated value represents the difference in Least Squares Means between FF 100 µg AM and Placebo (FF 100 µg AM minus Placebo).|||0.152|0.001|
70920525|NCT01808339|141331553|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.105|||||TWO_SIDED|90.0|0.029|0.18|||||The estimated value represents the difference in Least Squares Means between FF 100 µg PM and Placebo (FF 100 µg PM minus Placebo).|||0.180|0.029|
70920526|NCT01808339|141331553|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.028|||||TWO_SIDED|90.0|-0.102|0.045|||||The estimated value represents the difference in Least Squares Means between FF 100 µg AM and FF 100 µg PM (FF 100 µg AM minus FF 100 µg PM).|||0.045|-0.102|
70920527|NCT02622568|141331557|NON_INFERIORITY|Veregen alone has efficacy compared to Veregen + cryotherapy|Mean Difference (Final Values)|1.556||||0.383|TWO_SIDED|||||Comparison at week 12|t-test, 2 sided|||||||0.383
70920528|NCT02622568|141331557|NON_INFERIORITY|Comparison at week 0|Mean Difference (Final Values)|-0.222||||0.81|TWO_SIDED||||||t-test, 2 sided|||||||0.81
70920529|NCT00106080|141331562|SUPERIORITY_OR_OTHER_LEGACY||Difference between groups after adjust|5.7||||0.03||||||No multiple comparisons, a priori threshold \< 0.05|GEE regression|Generalized estimating equations (GEE) regression, clustering for provider.||Power calculation: With 60 providers in each group, maintaining the probability of a type I error of 0.05, power of 0.90, provider level mean QOC score of 54.5 and provider level standard deviation in QOC score of 12.0, the minimal detectable difference in QOC score would be 7.5.||||0.03
70920530|NCT02549170|141331564|SUPERIORITY||Newcombe confidence interval|-21.8|||=|0.0045|TWO_SIDED|95.0|-34.45|-7.94|||Chi-squared|||||-7.94|-34.45|=0.0045
71094681|NCT02989389|141697323|SUPERIORITY||Mean Difference (Final Values)|-19.6||||0.015|TWO_SIDED|90.0|-33.69|-2.51|||Mixed Models Analysis|||Aβ 1-42||-2.51|-33.69|0.015
71094682|NCT02989389|141697323|SUPERIORITY||Mean Difference (Final Values)|-65.41|||<|0.001|TWO_SIDED|90.0|-72.23|-56.92|||Mixed Models Analysis|||Aβ 1-42||-56.92|-72.23|<0.001
71094683|NCT02989389|141697323|SUPERIORITY||Mean Difference (Final Values)|-84.56|||<|0.001|TWO_SIDED|90.0|-88.97|-78.38|||Mixed Models Analysis|||Aβ 1-42||-78.38|-88.97|<0.001
70973275|NCT02889796|141453199|SUPERIORITY||Least Squares Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|1.6|3.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.9|1.6|<0.001
70973276|NCT02889796|141453205|SUPERIORITY||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.2||0.049|TWO_SIDED|95.0|0.0|5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.0|0.0|0.049
70973277|NCT02889796|141453205|SUPERIORITY||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.2||0.069|TWO_SIDED|95.0|0.0|5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.0|-0.0|0.069
70973278|NCT02889796|141453205|SUPERIORITY||Least Squares Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|4.0|9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||9.0|4.0|<0.001
70973279|NCT02889796|141453205|SUPERIORITY||Least Squares Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|4.0|9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||9.0|4.0|<0.001
70973280|NCT02889796|141453205|SUPERIORITY||Least Squares Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|1.5||0.06|TWO_SIDED|95.0|0.0|6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||6.0|-0.0|0.060
70973281|NCT02889796|141453205|SUPERIORITY||Least Squares Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|1.5||0.003|TWO_SIDED|95.0|2.0|8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||8.0|2.0|0.003
70973282|NCT01394081|141453228|SUPERIORITY||||||<|0.0001|||||||Chi-squared, Corrected|||||||<.0001
70973283|NCT01394081|141453229|SUPERIORITY||||||<|0.0001|||||||Log Rank|log rank Mantel Cox χ2 = 25.4||||||<.0001
70973284|NCT02814565|141453242|SUPERIORITY|||||||0.6179|TWO_SIDED|95.0|||||Wilcoxon Rank Sum test|||The 2-sample Wilcoxon rank sum test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.6179
70973285|NCT02814565|141453243|SUPERIORITY|||||||0.4338|||||||Wilcoxon Rank Sum Test|||Day 7. The 2-sample Wilcoxon rank sum test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.4338
70973286|NCT02814565|141453243|SUPERIORITY|||||||0.1657|||||||Wilcoxon Rank Sum Test|||Day 14. The 2-sample Wilcoxon rank sum test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.1657
70973287|NCT02814565|141453244|SUPERIORITY|||||||0.0393|||||||Wilcoxon Sum Rank Test|||The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0393
70973288|NCT02814565|141453245|SUPERIORITY|||||||0.033|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0330
70973289|NCT02814565|141453245|SUPERIORITY|||||||0.0262|||||||Wilcoxon Sum Rank Test|||Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0262
71032389|NCT00829673|141573637|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|107.82||||||90.0|100.24|115.98|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||115.98|100.24|
71032390|NCT00829673|141573638|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.74||||||90.0|97.3|104.29|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104.29|97.3|
71094684|NCT04470427|141697332|OTHER||VE|93.2|||<|0.0001|TWO_SIDED|95.0|91.0|94.8|||Vaccine Efficacy (VE)|VE (percent) is demonstrated if the lower limit of the 2-sided confidence interval for the VE is above 30%.|VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.|"Vaccine efficacy was defined as the percent reduction in the hazard of the primary endpoint (mRNA-1273 vs. placebo).~Null hypothesis of Vaccine Efficacy ≤30%, 95% CI."||94.8|91.0|<.0001
71094685|NCT04470427|141697338|OTHER||VE|98.2|||||TWO_SIDED|95.0|92.8|99.6|||VE||VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.|||99.6|92.8|
71094686|NCT04470427|141697339|OTHER||VE|82.0|||||TWO_SIDED|95.0|79.5|84.2|||||VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model|||84.2|79.5|
71094687|NCT04470427|141697340|OTHER|VE|VE|93.4|||||TWO_SIDED|95.0|91.4|94.9|||||VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.|||94.9|91.4|
71094688|NCT04470427|141697342|OTHER||VE|93.3|||||TWO_SIDED|95.0|91.1|94.9|||||VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.|||94.9|91.1|
71094689|NCT04470427|141697343|OTHER||VE|82.0|||||TWO_SIDED|95.0|79.5|84.3|||||VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.|||84.3|79.5|
71094690|NCT04470427|141697344|OTHER||VE|63.0|||||TWO_SIDED|95.0|56.6|68.5|||||VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.|||68.5|56.6|
71094691|NCT04470427|141697350|NON_INFERIORITY|Non-inferiority of a booster as compared with mRNA-1273 after second dose based on Ratio of GMC is demonstrated if lower bound of 95% CI of Ratio of GMC ≥ 0.67.|Ratio of GMC|6.996|||||TWO_SIDED|95.0|6.509|7.52||||||Ratio of GMC 28 days following the booster dose (BD-Day 29) compared with 28 days following second dose (Part A-Day 57).||7.520|6.509|
70920531|NCT02549170|141331566|SUPERIORITY||Newcombe confidence interval|-16.9|||=|0.0896|TWO_SIDED|95.0|-33.02|0.69||The treatment groups were compared using a continuity-corrected chi-square test.|Chi-squared, Corrected|||||0.69|-33.02|=0.0896
70920532|NCT02549170|141331567|SUPERIORITY||||||=|0.002|||||||Wilcoxon Survival Test|||||||=0.002
70920533|NCT02549170|141331568|SUPERIORITY||Least Square Mean|5.2|||=|0.03|TWO_SIDED|95.0|0.5|9.9|||ANCOVA|||||9.9|0.5|=0.030
70920534|NCT00595790|141331613|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of non-inferiority of IC51 1x12 mcg vs. IC51 2x6 mcg at Day 56 based on the difference (IC51 1x12 mcg - IC51 2x6 mcg) in SCRs in the PP population. Non-inferiority of IC51 1 x 12 mcg compared to IC51 2 x 6 mcg was accepted if the lower limit of the 95% CI of the adjusted for center SCR difference (IC51 1 x 12 mcg - IC51 2 x 6 mcg) was higher than the noninferiority margin at -10%.|||||>|0.99|||||||Mantel Haenszel|||||||>0.99
70920535|NCT03988023|141331617|SUPERIORITY|||||||0.32|||||||MMRM|||||||0.32
70920536|NCT03988023|141331618|SUPERIORITY|||||||0.3|||||||MMRM|||||||0.30
70920537|NCT03703336|141331619|NON_INFERIORITY|If the lower limit of the 95% confidence interval (CI) of the ratio of GMCs between the ROTAVIN and ROTAVIN-M1 groups were to be larger than 1/2, ROTAVIN was considered to be non-inferior to the licensed frozen formulation of the vaccine (ROTAVIN-M1).|GMC Ratio|1.38|||||TWO_SIDED|95.0|1.02|1.86|||||Log10-transformed IgA concentrations were used to construct a 2-sided 95% CI for the mean difference between the arms using t-distribution. The mean difference and 95% CI were exponentiated to obtain the GMC ratio and corresponding 95% CI.|||1.86|1.02|
70920538|NCT03703336|141331621|OTHER||Percentage Difference|6.0|||||TWO_SIDED|95.0|-3.57|15.87||||||||15.87|-3.57|
70920539|NCT03703336|141331622|OTHER||Percentage Difference|0.4|||||TWO_SIDED|95.0|-2.4|2.09||||||Percentage Difference on Day 1||2.09|-2.40|
70920540|NCT03703336|141331622|OTHER||Percentage Difference|6.3|||||TWO_SIDED|95.0|-3.19|16.23||||||Percentage Difference on Day 85||16.23|-3.19|
70920541|NCT02088853|141331629|SUPERIORITY|Wilcoxon test|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70920542|NCT02088853|141331630|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70920543|NCT02088853|141331631|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
70920544|NCT01736215|141331637|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.343||||0.266|TWO_SIDED|95.0|0.052|2.261||The binary logistic regression analysis was performed using a crude model between predictor variable endogenous EPO (EPO less than or equal to 45.2 and EPO greater than 45.3)|Regression, Logistic|||||2.261|0.052|0.266
70920545|NCT01736215|141331638|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.125||||0.05|TWO_SIDED|95.0|0.016|0.999||The binary logistic regression analysis was performed using a crude model between predictor variable CRP (CRP less than or equal to 10.3 and CRP greater than 10.4)|Regression, Logistic|||||0.999|0.016|0.05
70920546|NCT02238483|141331682|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.39||||0.2371|TWO_SIDED|95.0|0.81|2.4|||Regression, Cox||A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.|H0: Hazard Ratio (AZD7624/placebo) equals 1 vs. H1: Hazard Ratio does not equal 1.||2.40|0.81|0.2371
70920547|NCT02238483|141331683|SUPERIORITY_OR_OTHER||Rate Ratio|1.33|STANDARD_ERROR_OF_MEAN|0.33||0.249|TWO_SIDED|95.0|0.82|2.16|||regression, negative binomial||A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.|||2.16|0.82|0.249
70920548|NCT02238483|141331684|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49||||0.1261|TWO_SIDED|95.0|0.89|2.5|||Regression, Cox||A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.|||2.50|0.89|0.1261
70920549|NCT02238483|141331685|SUPERIORITY_OR_OTHER||Rate ratio|1.4|STANDARD_ERROR_OF_MEAN|0.33||0.157|TWO_SIDED|95.0|0.88|2.21|||regression, negative binomial|||||2.21|0.88|0.157
70920550|NCT02238483|141331686|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.53||||0.1529|TWO_SIDED|95.0|0.85|2.76|||Regression, Cox|||||2.76|0.85|0.1529
71032391|NCT00829673|141573639|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.5||||||90.0|97.09|104.03|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104.03|97.09|
71094692|NCT04470427|141697351|NON_INFERIORITY|Non-inferiority of a booster as compared with mRNA-1273 after second dose based on SRR difference is demonstrated if lower bound of 95% CI of SRR difference \> -10%.|Difference in Seroresponse|0.9|||||TWO_SIDED|95.0|0.1|1.8|||||95% CI were calculated using adjusted Wald method for the paired binary data.|Seroresponse 28 days following the booster dose (BD-Day 29) compared with 28 days following second dose (Part A-Day 57)||1.8|0.1|
71032392|NCT00829790|141573650|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|114.49||||||90.0|109.25|119.98|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||119.98|109.25|
71032393|NCT00829790|141573651|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|117.16||||||90.0|110.44|124.28|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||124.28|110.44|
71032394|NCT00829790|141573652|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|116.7||||||90.0|109.89|123.92|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||123.92|109.89|
71032395|NCT00627016|141573668|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance for the comparison of the primary endpoint was determined at 0.05 level.|Wilcoxon (Mann-Whitney)|||||||<0.001
71032396|NCT00627016|141573669|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was only declared if the primary endpoint was statistically significant at 0.05 level. The multiplicity between the two secondary endpoints was adjusted by Hommel-Simes method to maintain the overall 0.05 level.|Fisher Exact|||||||<0.001
71032397|NCT00627016|141573670|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was only declared if the primary endpoint was statistically significant at 0.05 level. The multiplicity between the two secondary endpoints was adjusted by Hommel-Simes method to maintain the overall 0.05 level.|Fisher Exact|||||||<0.001
71032398|NCT04567186|141573674|SUPERIORITY|The superiority of the Test lens was concluded if the upper 95% confidence limit of the mean was below the pre-defined threshold +0.00 logMAR.|Least-square mean|-0.078|STANDARD_ERROR_OF_MEAN|0.0105|||TWO_SIDED|95.0|-0.099|-0.057|||Linear Mixed Model|Kenward and Roger Method was used for denominator degrees of freedom|Distance (4 meter)|It was calculated that 70 participants would have at least 90% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 1-week follow-up. Sample size was determined using one sample means test for equivalence||-0.057|-0.099|
71032399|NCT04567186|141573674|SUPERIORITY|The superiority of the Test lens was concluded if the upper 95% confidence limit of the mean was below the pre-defined threshold + 0.17 logMAR.|Least-square mean|-0.059|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.079|-0.039|||Linear Mixed Model|Kenward and Roger Method was used for denominator degrees of freedom|Intermediate (64cm)|It was calculated that 70 participants would have at least 90% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 1-week follow-up. Sample size was determined using one sample means test for equivalence||-0.039|-0.079|
71032400|NCT04567186|141573674|SUPERIORITY|The superiority of the Test lens was concluded if the upper 95% confidence limit of the mean was below the pre-defined threshold +0.17 logMAR.|Least-square Mean|0.062|STANDARD_ERROR_OF_MEAN|0.0111|||TWO_SIDED|95.0|0.04|0.084|||Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom|Near (40cm)|It was calculated that 70 participants would have at least 90% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 1-week follow-up. Sample size was determined using one sample means test for equivalence||0.084|0.040|
71032401|NCT04567186|141573675|SUPERIORITY|The superiority of the Test lens was concluded if the lower confidence limit of the least-square mean was above the threshold of 32 points.|Least-square Mean|55.93|STANDARD_ERROR_OF_MEAN|2.9027|||TWO_SIDED|95.0|49.25|62.61|||Linear Mixed Model|The Kenward and Roger method was used for the denominator degrees of freedom||This study was powered to only test primary hypotheses.||62.61|49.25|
71032402|NCT04567186|141573675|NON_INFERIORITY|A Non-Inferiority margin of 5 points was used.|Least-square mean difference|-2.98|STANDARD_ERROR_OF_MEAN|1.4708|||TWO_SIDED|95.0|-5.893|-0.073|||Linear Mixed Model|The Kenward and Roger Method was used for the denominator degrees of freedom|mean difference was calculated as Test minus Control|This study was powered for only the primary hypotheses.||-0.073|-5.893|
70920551|NCT02238483|141331687|SUPERIORITY_OR_OTHER||rate ratio|1.5|STANDARD_ERROR_OF_MEAN|0.4||0.129|TWO_SIDED|95.0|0.89|2.52|||regression, negative binomial|||||2.52|0.89|0.129
70920552|NCT02238483|141331688|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.8543|TWO_SIDED|95.0|0.43|2.01|||Regression, Cox||A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.|||2.01|0.43|0.8543
70920553|NCT02238483|141331689|SUPERIORITY_OR_OTHER||rate ratio|1.12|STANDARD_ERROR_OF_MEAN|0.41||0.751|TWO_SIDED|95.0|0.55|2.29|||regression, negative binomial|||||2.29|0.55|0.751
70920554|NCT02238483|141331690|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.5381|TWO_SIDED|95.0|0.54|1.38|||Regression, Cox||A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.|||1.38|0.54|0.5381
70920555|NCT02238483|141331691|SUPERIORITY_OR_OTHER||rate ratio|0.84|STANDARD_ERROR_OF_MEAN|0.19||0.44|TWO_SIDED|95.0|0.55|1.3|||regression, negative binomial|||||1.30|0.55|0.440
70920556|NCT02238483|141331692|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.37||||0.5474|TWO_SIDED|95.0|-1.6|0.85|||Mixed Models Analysis||LSMean difference for overall treatment effect. Negative values for a difference show AZD7624 to have a favourable outcome compared to Placebo|||0.85|-1.60|0.5474
70920557|NCT02238483|141331693|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.83||||0.6352|TWO_SIDED|95.0|-2.62|4.29|||Mixed Models Analysis||LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo|||4.29|-2.62|0.6352
70920558|NCT02238483|141331694|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.2694|TWO_SIDED|95.0|-0.34|0.1|||Mixed Models Analysis||LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo|||0.10|-0.34|0.2694
70920559|NCT02238483|141331695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.5144|TWO_SIDED|95.0|-0.03|0.07|||Mixed Models Analysis||LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo|||0.07|-0.03|0.5144
71032403|NCT02331394|141573684|EQUIVALENCE|"The equivalence assumes that the true mean difference between the paired samples is zero. Under this model, all observable differences are explained by random variation.Equality margins are:~Upper Equivalence Margin=1.5 Lower Equivalence Margin=-1.5"|||||<|0.05|||||||t-test, 2 sided|||Comparisons of repeated measures were made using paired sample t test, which compared subjects data at 2 different times: baseline and end of the study. A P value of 0.05 was considered statistically significant||||<0.05
71032404|NCT02331394|141573687|SUPERIORITY|Pared t-test was used to evaluate the significance of the change in scores||||||0.02|||||||t-test, 2 sided|||||||0.02
71032405|NCT02459951|141573699|SUPERIORITY|||||||0.059||||||"refer to cylinder A (.5 diameter)"|Regression, Logistic|||||||.059
71032406|NCT02459951|141573699|SUPERIORITY||geometric mean ratio B|||||0.465|||||||Regression, Logistic|"refer to cylinder B(1 diameter)"||||||0.465
71032407|NCT02459951|141573699|SUPERIORITY||geometric mean ratio C|||||0.022||||||"refer to cylinder C (1.5 diameter)"|Regression, Logistic|||||||.022
71032408|NCT02459951|141573699|SUPERIORITY||geometric mean ratio D|||||0.004||||||"refer to cylinder D (2 diameter)"|Regression, Logistic|||||||.004
71032409|NCT02459951|141573699|SUPERIORITY||geometric mean ratio E|||||0.002||||||"refer to cylinder E (2.5 diameter)"|Regression, Logistic|||||||.002
71032410|NCT00102440|141573703|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of febuxostat 80 mg to allopurinol was declared if the value of the lower bound of the 97.5% confidence interval is \> -10%.|Difference in percentage|32.0||||||97.5|23.1|41.3||||||||41.3|23.1|
71032411|NCT00102440|141573703|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of febuxostat 120 mg to allopurinol was declared if the value of the lower bound of the 97.5% confidence interval is \> -10%.|Difference in percentage|41.0||||||97.5|31.5|49.5||||||||49.5|31.5|
71032412|NCT00102440|141573703|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparisons of each febuxostat dose to allopurinol were adjusted to control the overall 0.05 level of significance for superiority by using Hochberg's method for multiple comparisons.|Fisher Exact|||||||<0.001
71032413|NCT00102440|141573703|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparisons of each febuxostat dose to allopurinol were adjusted to control the overall 0.05 level of significance for superiority by using Hochberg's method for multiple comparisons.|Fisher Exact|||||||<0.001
71032414|NCT00102440|141573703|SUPERIORITY_OR_OTHER|||||||0.072||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.072
71032415|NCT00102440|141573704|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||<0.001
71032416|NCT00102440|141573704|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||<0.001
71032417|NCT00102440|141573704|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.031
71032418|NCT00102440|141573705|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||<0.001
71032419|NCT00102440|141573705|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||<0.001
71032420|NCT00102440|141573705|SUPERIORITY_OR_OTHER|||||||0.883||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.883
71032421|NCT00102440|141573706|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||<0.001
71032422|NCT00102440|141573706|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||<0.001
71032423|NCT00102440|141573706|SUPERIORITY_OR_OTHER|||||||0.164||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.164
71032424|NCT00102440|141573707|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
71032425|NCT00102440|141573707|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
70973290|NCT02814565|141453246|SUPERIORITY|||||||0.5756|||||||Wilcoxon Sum Rank Test|||Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.5756
70920560|NCT02238483|141331696|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.5416|TWO_SIDED|95.0|-0.1|0.05|||Mixed Models Analysis||LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo|||0.05|-0.10|0.5416
70920561|NCT02238483|141331697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.1965|TWO_SIDED|95.0|0.0|0.02|||Mixed Models Analysis||LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo|||0.02|0.00|0.1965
70920562|NCT00539734|141331702|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Comparing pre-operative data with postoperative data in terms of changes in amplitude height and implicit time.||||<0.05
70920563|NCT03631550|141331720|SUPERIORITY|||||||0.018|||||||Chi-squared|||||||0.018
70920564|NCT03631550|141331721|SUPERIORITY|||||||0.0466|||||||Chi-squared|||||||0.0466
70920565|NCT03631550|141331722|SUPERIORITY|||||||0.0677|||||||Chi-squared|||||||0.0677
70920566|NCT03631550|141331723|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<.0001
70920567|NCT03631550|141331724|OTHER|||||||0.0968|||||||Fisher Exact|||||||0.0968
70920568|NCT03631550|141331725|SUPERIORITY|||||||0.0121|||||||ANCOVA|||||||0.0121
70920569|NCT00440011|141331732|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||ANCOVA|||||||0.024
70920570|NCT00419341|141331735|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of SCIG:IVIG treatment was concluded if the lower GMR confidence limit was 0.8 or more. With 18 evaluable subjects, the power to show this non-inferiority was calculated to be 85% based on the assumptions of an intra-individual variability with a coefficient of variation (CV) = 25% and a GMR equal to or greater than 1.|Geometric mean ratio (GMR)|1.002|||||TWO_SIDED|90.0|0.951|1.055||No P-value is provided as non-inferiority was assessed by the CI of the GMR.|t-test, 2 sided|Based on log-transformed individual differences.|Geometric mean ratio SCIG:IVIG non-inferiority was concluded if the lower GMR confidence limit was 0.8 or more|Individual sAUC values (standardized to a 7-day period) of the IV and adjusted SC sampling periods in each individual subject were log transformed and a parametric 2-sided 90% confidence interval (CI) for the mean of the individual differences was obtained. Back-transformation of the mean and its CI produced the geometric mean ratio (GMR) and its respective 90% CI.||1.055|0.951|
70920571|NCT02020252|141331760|SUPERIORITY|||||||0.307||||||This is for the receptivity sub-scale, and the comparison between pre and post-test scores.|t-test, 2 sided|This was a paired t-test.||||||.307
70920572|NCT02020252|141331760|SUPERIORITY|||||||0.009||||||This is for the willingness sub-scale, and the comparison between pre and posttest scores.|t-test, 2 sided|This was a paired t-test.||||||.009
70920573|NCT02020252|141331760|SUPERIORITY||||||<|0.001||||||This is for knowledge sub scale, and the comparison between pre and posttest scores.|t-test, 2 sided|A paired t-test.||||||<.001
70920574|NCT02020252|141331760|SUPERIORITY|||||||0.004||||||This is for the positive attitudes sub scale, and the comparison between pre and posttest scores.|t-test, 2 sided|This was a paired t-test.||||||.004
70920575|NCT02020252|141331760|SUPERIORITY||||||<|0.001||||||This was for the self-efficacy sub scale, and the comparison between pre and posttest scores.|t-test, 2 sided|This was a paired t-test.||||||<.001
70973291|NCT02814565|141453246|SUPERIORITY|||||||0.4395|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.4395
70920576|NCT04870645|141331817|OTHER||||||<|0.05|||||||Statistical Significance|||||||< 0.05
70920577|NCT03237481|141331873|SUPERIORITY||Least Squares Mean Difference (LSMD)|-81.43|STANDARD_ERROR_OF_MEAN|22.592|=|0.0004|TWO_SIDED|95.0|-125.83|-37.02|||ANOVA|||||-37.02|-125.83|= 0.0004
70920578|NCT03237481|141331874|SUPERIORITY||Least Squares Mean Difference (LSMD)|-72.49|STANDARD_ERROR_OF_MEAN|18.23|<|0.0001|TWO_SIDED|95.0|-108.32|-36.65|||ANOVA|||||-36.65|-108.32|< 0.0001
70920579|NCT03237481|141331875|SUPERIORITY||||||=|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||= 0.0001
70920580|NCT03237481|141331876|SUPERIORITY||Risk Difference (RD)|0.111|||=|0.0486|TWO_SIDED|95.0|0.003|0.218|||Fisher Exact|||||0.218|0.003|= 0.0486
70920581|NCT03237481|141331877|SUPERIORITY||||||=|0.024|||||||Wilcoxon (Mann-Whitney)|||||||= 0.024
70920582|NCT05773313|141331926|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||Food Insecurity||||>0.999
70920583|NCT05773313|141331926|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Financial Insecurity||||0.250
70920584|NCT05773313|141331926|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||Social Isolation||||>0.999
70920585|NCT05773313|141331926|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||Physical Inactivity||||>0.999
70920586|NCT05773313|141331926|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||Disability||||>0.999
70920587|NCT05773313|141331927|SUPERIORITY|||||||0.461|||||||Wilcoxon (Mann-Whitney)|||||||0.461
70920588|NCT05773313|141331928|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||||||>0.999
70920589|NCT05773313|141331929|SUPERIORITY|||||||0.438|||||||Wilcoxon (Mann-Whitney)|||||||0.438
70920590|NCT05773313|141331930|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.080
70920591|NCT02374463|141331936|SUPERIORITY||||||<|0.05||||||P value not adjusted for multiple comparisons|t-test, 2 sided|||within group change was assessed||||<0.05
70920592|NCT02374463|141331937|SUPERIORITY||||||=|0.08||||||p value not adjusted for multiple comparisons|ANOVA|||||||=0.08
70920593|NCT02374463|141331938|SUPERIORITY||||||=|0.6|||||||ANOVA|not adjusted for multiple comparisons||||||=0.6
70920594|NCT02374463|141331939|SUPERIORITY|||||||0.84||||||Not adjusted for multiple comparisons|Chi-squared|exploratory aim prespecified.||||||0.84
70920595|NCT02374463|141331939|SUPERIORITY||||||=|0.4|||||||Chi-squared|||||||=0.4
70920596|NCT02374463|141331940|SUPERIORITY||||||=|0.3||||||not adjusted for multiple comparisons|ANOVA|||||||=0.3
70920597|NCT02374463|141331941|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
70920598|NCT01266122|141331946|SUPERIORITY_OR_OTHER||log(Incident Risk Ratio)|-0.95|||<|0.001|TWO_SIDED|95.0|-1.47|-0.44|||Mixed Models Analysis|Mixed effects Poisson regression||Intent to treat analysis||-.44|-1.47|<.001
70920599|NCT01266122|141331947|SUPERIORITY_OR_OTHER||Chi-square statistic|1.39|||=|0.239|TWO_SIDED||||||Chi-squared|||Intent to treat analysis.||||=.239
71032426|NCT00102440|141573707|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
71032427|NCT00102440|141573708|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
71032428|NCT00102440|141573708|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
71032429|NCT00102440|141573708|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||0.006
71032430|NCT00102440|141573709|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
70920600|NCT03756571|141331959|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
70920601|NCT03756571|141331960|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.50
70920602|NCT03756571|141331961|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
70920603|NCT03756571|141331962|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||||||0.23
70920604|NCT03756571|141331963|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.70
70920605|NCT03756571|141331964|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||||||0.33
70920606|NCT03756571|141331965|SUPERIORITY|||||||0.03|||||||Regression, Linear|||||||0.03
70920607|NCT03756571|141331966|SUPERIORITY|||||||0.03|||||||Regression, Linear|||||||0.03
70920608|NCT03756571|141331967|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
70920609|NCT03756571|141331968|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||||||0.18
70920610|NCT03756571|141331969|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
70920611|NCT03756571|141331970|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.80
70973292|NCT02814565|141453246|SUPERIORITY|||||||0.0905|||||||Wilcoxon Sum Rank Test|||Day 14. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0905
70973293|NCT02814565|141453247|SUPERIORITY|||||||1|||||||Fisher Exact|||"Day 3. A two-tailed Fisher's exact test to compare the number of responders between the Placebo and the Cyclobenzaprine HCl 15 mg treatment group to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance."||||1.0000
70973294|NCT02814565|141453247|SUPERIORITY|||||||1|||||||Fisher Exact|||"Day 7. A two-tailed Fisher's exact test to compare the number of responders between the Placebo and the Cyclobenzaprine HCl 15 mg treatment group to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance."||||1.0000
70973295|NCT02814565|141453247|SUPERIORITY|||||||0.2757|||||||Fisher Exact|||"Day 14. A two-tailed Fisher's exact test to compare the number of responders between the Placebo and the Cyclobenzaprine HCl 15 mg treatment group to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance."||||0.2757
70973296|NCT02814565|141453248|SUPERIORITY|||||||0.302|||||||Wilcoxon Sum Rank Test|||Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.3020
70973297|NCT02814565|141453248|SUPERIORITY|||||||0.2367|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.2367
70973298|NCT02814565|141453248|SUPERIORITY|||||||0.025|||||||Wilcoxon Sum Rank Test|||Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0250
70973299|NCT02814565|141453249|SUPERIORITY|||||||0.4428|||||||Wilcoxon Sum Rank Test|||Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.4428
70973300|NCT02814565|141453249|SUPERIORITY|||||||0.1163|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.1163
70973301|NCT02814565|141453249|SUPERIORITY|||||||0.0489|||||||Wilcoxon Sum Rank Test|||Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0489
70973302|NCT02814565|141453250|SUPERIORITY|||||||0.5275|||||||Wilcoxon Sum Rank Test|||Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.5275
70973303|NCT02814565|141453250|SUPERIORITY|||||||0.088|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0880
70973304|NCT02814565|141453250|SUPERIORITY|||||||0.2542|||||||Wilcoxon Sum Rank Test|||Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.2542
70973305|NCT02814565|141453251|SUPERIORITY|||||||0.692|||||||Wilcoxon Sum Rank Test|||Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.6920
70973306|NCT02814565|141453251|SUPERIORITY|||||||0.0749|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0749
70973307|NCT02814565|141453251|SUPERIORITY|||||||0.2371|||||||Wilcoxon Sum Rank Test|||Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.2371
70973308|NCT01784965|141453280|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70973309|NCT05215600|141453284|OTHER|P-values account for preoperative versus postoperative mean values at 1 and 2 years|||||<|0.001|||||||t-test, 2 sided|T-Test (Pooled)||||||<0.001
70973310|NCT05215600|141453285|OTHER|P-values account for preoperative versus postoperative mean values at 1 and 2 years|||||<|0.001|||||||t-test, 2 sided|T-Test (Pooled)||||||<0.001
70973311|NCT04175626|141453287|SUPERIORITY||||||<|0.0001|||||||Exact, binomial|||The primary endpoint was evaluated by performing an exact, binomial test comparing the rate of TLF for the Orsiro stent at 1 year to a performance goal of 6.9%, with Type I error (alpha) of 0.025 and power of 80%. The null hypothesis (Ho) was stated as: The TLF rate of the Orsiro stent at 1 year is greater than or equal to 6.9%. The alternative hypothesis (Ha) was stated as: The TLF rate of the Orsiro stent at 1 year is less than 6.9%.||||<0.0001
70973312|NCT03178487|141453300|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint.|Response Rate Difference|26.1|||<|0.001|TWO_SIDED|95.0|12.6|39.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusting for stratification factor of Screening hsCRP level.|Response Rate Difference = Upadacitinib - Placebo|||39.5|12.6|<0.001
70973313|NCT03178487|141453301|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint.|Least Squares (LS) Mean Difference|-0.91|||<|0.001|TWO_SIDED|95.0|-1.14|-0.68|||Mixed Effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction as fixed effects and Screening hsCRP level and Baseline value as covariates.|Treatment difference = Upadacitinib - Placebo|||-0.68|-1.14|<0.001
70973314|NCT03178487|141453302|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint.|LS Mean Difference|-6.71|||<|0.001|TWO_SIDED|95.0|-9.01|-4.41|||ANCOVA|ANCOVA model including treatment and Screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-4.41|-9.01|<0.001
70973315|NCT03178487|141453303|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including BASDAI 50; within the group, the allocated α was adjusted based on the magnitude of p values.|Response Rate Difference|21.8||||0.002|TWO_SIDED|95.0|8.5|35.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for stratification factor of Screening hsCRP level.|Response rate difference = Upadacitinib - Placebo|||35.0|8.5|0.002
70973316|NCT03178487|141453304|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including ASQoL; within the group, the allocated α was adjusted based on the magnitude of p values.|LS Mean Difference|-1.54||||0.016|TWO_SIDED|95.0|-2.78|-0.3|||Mixed Effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction as fixed effects and Screening hsCRP level and Baseline value as covariates.|Treatment difference = Upadacitinib - Placebo|||-0.30|-2.78|0.016
70973317|NCT03178487|141453305|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including ASAS PR; within the group, the allocated α was adjusted based on the magnitude of p values.|Response Rate Difference|18.3|||<|0.001|TWO_SIDED|95.0|10.0|26.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for stratification factor of Screening hsCRP level.|Response rate difference = Upadacitinib - Placebo|||26.6|10.0|<0.001
70973318|NCT03178487|141453306|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including BASFI; within the group, the allocated α was adjusted based on the magnitude of p values.|LS Mean Difference|-1.0||||0.001|TWO_SIDED|95.0|-1.6|-0.39|||Mixed Effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction as fixed effects and Screening hsCRP level and Baseline value as covariates.|Treatment difference = Upadacitinib - Placebo|||-0.39|-1.60|0.001
71008734|NCT02055976|141525247|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.287|STANDARD_ERROR_OF_MEAN|12.705||0.311|TWO_SIDED|95.0|-31.541|18.968|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||18.968|-31.541|0.311
70973319|NCT03178487|141453307|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including BASMI(lin); within the group, the allocated α was adjusted based on the magnitude of p values.|LS Mean Difference|-0.22||||0.03|TWO_SIDED|95.0|-0.43|-0.02|||ANCOVA|ANCOVA model including treatment and Screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-0.02|-0.43|0.030
70973320|NCT03178487|141453308|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including MASES; within the group, the allocated α was adjusted based on the magnitude of p values.|LS Mean Difference|-0.84||||0.049|TWO_SIDED|95.0|-1.68|0.0|||Mixed Effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction as fixed effects and Screening hsCRP level and Baseline value as covariates.|Treatment difference = Upadacitinib - Placebo|||-0.00|-1.68|0.049
70973321|NCT03178487|141453309|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including WPAI; within the group, the allocated α was adjusted based on the magnitude of p values.|LS Mean Difference|-5.52||||0.19|TWO_SIDED|95.0|-13.82|2.78|||ANCOVA|ANCOVA model including treatment and Screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||2.78|-13.82|0.190
70973322|NCT03178487|141453310|OTHER|"To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint.~ASAS HI was to be evaluated only if the group of endpoints tested by Hochberg procedure were all significant."|LS Mean Difference|-1.37||||0.007|TWO_SIDED|95.0|-2.37|-0.37||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped during the Hochberg procedure.|Mixed Effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction as fixed effects and Screening hsCRP level and Baseline value as covariates.|Treatment difference = Upadacitinib - Placebo|||-0.37|-2.37|0.007
70973323|NCT03178487|141453311|OTHER||Response Rate Difference|24.1||||0.001|TWO_SIDED|95.0|10.2|38.0||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for stratification factor of Screening hsCRP level.|||Response Rate Difference = Upadacitinib - Placebo|38.0|10.2|0.001
70973324|NCT03178487|141453312|OTHER||LS Mean Difference|-3.69|||<|0.001|TWO_SIDED|95.0|-5.31|-2.08||This comparison was not part of the pre-specified multiplicity testing sequence.|ANCOVA|ANCOVA model including treatment and Screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-2.08|-5.31|<0.001
70973325|NCT03178487|141453313|OTHER||LS Mean Difference|-6.21|||<|0.001|TWO_SIDED|95.0|-8.27|-4.14|||ANCOVA|ANCOVA model including treatment and Screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-4.14|-8.27|<0.001
70973326|NCT03178487|141453314|OTHER||LS Mean Difference|-2.55|||<|0.001|TWO_SIDED|95.0|-4.01|-1.08|||ANCOVA|ANCOVA model including treatment and Screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-1.08|-4.01|<0.001
70973327|NCT00493038|141453320|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was set to 15% in the protocol. Sample size was estimated using the method as described in Farrington-Manning (STATISTICS IN MEDICINE, Vol. 9; Farrington CP, Manning G: Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference..., pg.1447-1454 \[1990\]). Estimation was performed to achieve 90% power, based on the equivalence delta of 15%, and a clinical success rate of 80% in the per protocol population."|Mean Difference (Final Values)|2.1||||||95.0|-1.9|6.2|||||Mean difference denotes the difference of clinical cure rates between the two treatment groups (moxifloxacin minus amoxicillin/clavulanate).|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||6.2|-1.9|
70973328|NCT00493038|141453321|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was set to 15% in the protocol. Sample size was estimated using the method as described in Farrington-Manning (STATISTICS IN MEDICINE, Vol. 9; Farrington CP, Manning G: Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference..., pg.1447-1454 \[1990\]). Estimation was performed to achieve 90% power, based on the equivalence delta of 15%, and a clinical success rate of 80% in the per protocol population."|Mean Difference (Final Values)|-0.5||||||95.0|-7.9|6.8||||||Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||6.8|-7.9|
70973329|NCT00493038|141453322|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was set to 15% in the protocol. Sample size was estimated using the method as described in Farrington-Manning (STATISTICS IN MEDICINE, Vol. 9; Farrington CP, Manning G: Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference..., pg.1447-1454 \[1990\]). Estimation was performed to achieve 90% power, based on the equivalence delta of 15%, and a clinical success rate of 80% in the per protocol population."|Mean Difference (Final Values)|1.7||||||95.0|-3.8|7.1||||||Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||7.1|-3.8|
70973330|NCT00119158|141453339|NON_INFERIORITY_OR_EQUIVALENCE|modified EASI (eczema area severity index) was considered equivalent if p value was greater than \>0.05|||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
70973331|NCT04311086|141453380|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||>|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.||||>0.05
70973332|NCT04311086|141453381|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||>|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.||||>0.05
70973333|NCT04311086|141453382|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||>|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment||||>0.05
70973334|NCT04311086|141453383|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||>|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.||||>0.05
70973335|NCT04311086|141453387|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||<|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.||||<0.05
70973336|NCT04311086|141453388|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||<|0.05|||||||ANCOVA|||||||<0.05
70973337|NCT04311086|141453389|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||>|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.||||>0.05
70973338|NCT04311086|141453390|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||>|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.||||>0.05
70973339|NCT00355394|141453391|SUPERIORITY_OR_OTHER|||||||0.03|||||||Fisher Exact|||||||0.03
70973340|NCT00355394|141453392|SUPERIORITY_OR_OTHER|||||||0.02|||||||Fisher Exact|||||||0.02
70973341|NCT00355394|141453393|SUPERIORITY_OR_OTHER|||||||0.46|||||||Fisher Exact|||||||0.46
70973342|NCT00355394|141453394|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
70973343|NCT00355394|141453395|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.01
70973344|NCT00355394|141453396|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.50
71008735|NCT02055976|141525247|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-32.443|STANDARD_ERROR_OF_MEAN|12.555||0.006|TWO_SIDED|95.0|-57.4|-7.485|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-7.485|-57.400|0.006
71008736|NCT02055976|141525249|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-35.967|STANDARD_ERROR_OF_MEAN|10.822|<|0.001|TWO_SIDED|95.0|-57.463|-14.472|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-14.472|-57.463|<0.001
70973345|NCT01175902|141453404|NON_INFERIORITY_OR_EQUIVALENCE|"To prove the non-inferiority of Cosopt to Xalatan, the sample size calculation was based on the assumption that non-inferiority margin of trough IOP of 1.5mmHg. A sample size of n=21 patients per group, this study has 80% power (1-β=0.80) and α=0.05, crossover-designed analysis.~In this study, the upper limit of the 95% CI is expected above the maximal acceptable clinically significant difference of 1.5 mmHg of IOP."|Mean Difference (Final Values)|0.9||||0.05|TWO_SIDED|||||Comparison between two arms were made for IOP, systolic BP, diastolic BP and OPP at each time period.|t-test, 2 sided|Comparison between two arms were made for IOP, systolic BP, diastolic BP and OPP at each time period.|Comparison between two arms were made for IOP, systolic BP, diastolic BP and OPP at each time period.|Comparison between two arms were made for IOP, systolic BP, diastolic BP and OPP at each time period.||||0.05
71094693|NCT01179516|141697352|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|1.488||0.597|TWO_SIDED|95.0|-3.71|2.14||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||All statistical tests were 2-sided with the estimated P-values at the 5% level of significance. To control for multiplicity, a pre-specified sequential testing procedure for each dose was applied to compare 10 mg and 15 mg vortioxetine to placebo. Efficacy endpoints were tested for each dose in sequential order at significance level 0.025; as soon as an endpoint was non-significant at 0.025, the testing procedure stopped for all subsequent endpoints.||2.14|-3.71|0.597
71094694|NCT01179516|141697352|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|1.501||0.745|TWO_SIDED|95.0|-3.44|2.46||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||2.46|-3.44|0.745
71094695|NCT01179516|141697353|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.232||||0.396|TWO_SIDED|95.0|0.761|1.995|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.995|0.761|0.396
71094696|NCT01179516|141697353|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.212||||0.435|TWO_SIDED|95.0|0.748|1.963|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.963|0.748|0.435
70973346|NCT00411554|141453413|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin (Sitagliptin minus Voglibose) = 0.2 percent|Least-squares Mean Difference|-0.39|||<|0.001||95.0|-0.51|-0.28||"This p-value corresponds to a test of superiority that was performed after success was achieved in the test of non-inferiority (reported under Estimation below), according to the pre-specified analysis plan"|ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to compare two groups|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to show non-inferiority and superiority to voglibose (closed procedure) and to estimate difference of two groups and its 95% confidence interval|||-0.28|-0.51|<0.001
70973347|NCT00411554|141453414|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-10.7|||<|0.001||95.0|-15.3|-6.2|||ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to compare two groups|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to show superiority to voglibose and to estimate difference of two groups and its 95% confidence interval|||-6.2|-15.3|<0.001
70973348|NCT00411554|141453415|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-18.8|||<|0.001||95.0|-26.7|-10.9|||ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to compare two groups|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to show superiority to voglibose and to estimate difference of two groups and its 95% confidence interval|||-10.9|-26.7|<0.001
70973349|NCT00699907|141453416|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon Rank Sum Test|||||||0.012
70973350|NCT00699907|141453416|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Rank Sum Test|||||||>0.05
70973351|NCT00699907|141453417|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon Rank Sum Test|||||||0.010
70973352|NCT00699907|141453417|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon Rank Sum Test|||||||0.005
70973353|NCT00699907|141453418|SUPERIORITY_OR_OTHER|||||||0.0006|||||||Wilcoxon Rank Sum Test|||||||0.0006
71094697|NCT01179516|141697354|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.149||0.554|TWO_SIDED|95.0|-0.38|0.21|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||0.21|-0.38|0.554
70973354|NCT00699907|141453418|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Rank Sum Test|||||||>0.05
70973355|NCT00699907|141453419|SUPERIORITY_OR_OTHER|||||||0.009|||||||Wilcoxon Rank Sum Test|||||||0.009
70973356|NCT00699907|141453419|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Rank Sum Test|||||||>0.05
70973357|NCT00699907|141453420|SUPERIORITY_OR_OTHER|||||||0.037|||||||Wilcoxon Rank Sum Test|||||||0.037
70973358|NCT00699907|141453420|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Rank Sum Test|||||||>0.05
70973359|NCT00699907|141453421|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon Rank Sum Test|||||||0.010
70973360|NCT00699907|141453421|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Rank Sum Test|||||||>0.05
70973361|NCT00699907|141453422|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon Rank Sum Test|||||||0.005
70973362|NCT00699907|141453422|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Rank Sum Test|||||||>0.05
70973363|NCT00699907|141453423|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon Rank Sum Test|||||||0.006
70973364|NCT00699907|141453423|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon Rank Sum Test|||||||0.005
70973365|NCT00699907|141453424|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum Test|||||||<0.0001
70973366|NCT00699907|141453424|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon Rank Sum Test|||||||0.005
70973367|NCT02161211|141453425|SUPERIORITY|||||||0.673|||||||Chi-squared|df = 2||Null hypothesis = no difference in frequency in relapse between groups||||.673
70973368|NCT02161211|141453426|SUPERIORITY||Wald Chi-squared|-0.278||||0.133|TWO_SIDED|95.0|-0.64|0.084|||Wald Chi-squared|Negative binomial regression with offset of natural log of possible drinking days||||.084|-.64|.133
70973369|NCT02161211|141453426|SUPERIORITY||Wald Chi-squared|0.101||||0.562|TWO_SIDED|95.0|-0.24|0.44|||Wald Chi-squared|||||.44|-.24|.562
71094698|NCT01179516|141697354|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.151||0.739|TWO_SIDED|95.0|-0.35|0.25|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||0.25|-0.35|0.739
70973370|NCT02161211|141453427|SUPERIORITY|||||||0.982|||||||ANOVA|F(2,105) = .019||||||.982
70973371|NCT02161211|141453428|SUPERIORITY|||||||0.685|||||||Chi-squared|||Null hypothesis = no difference in proportion between the groups||||.685
71094699|NCT01179516|141697355|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|2.261||0.67|TWO_SIDED|95.0|-5.43|3.5|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||3.50|-5.43|0.670
70973372|NCT02161211|141453429|SUPERIORITY|||||||0.608|||||||Chi-squared|||Null hypothesis = no significant difference in frequency of hazardous drinking between groups||||.608
71094700|NCT01179516|141697355|SUPERIORITY_OR_OTHER||LS Mean Difference|1.73|STANDARD_ERROR_OF_MEAN|2.295||0.451|TWO_SIDED|95.0|-2.8|6.26|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||6.26|-2.80|0.451
71094701|NCT01179516|141697356|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.291||||0.352|TWO_SIDED|95.0|0.754|2.211|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS total score.||||2.211|0.754|0.352
70973373|NCT00430508|141453430|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.3|||<|0.0001||95.0|-6.97|-3.6|||ANCOVA|||||-3.6|-6.97|<0.0001
70973374|NCT00430508|141453430|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.4|||<|0.0001||95.0|-4.79|-2.03|||ANCOVA|||||-2.03|-4.79|<0.0001
70973375|NCT00430508|141453430|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.1788||95.0|-2.32|0.43|||ANCOVA|||||0.43|-2.32|0.1788
70973376|NCT00430508|141453431|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1|||<|0.0001||95.0|-5.54|-2.6|||ANCOVA|||||-2.6|-5.54|<0.0001
70973377|NCT00430508|141453431|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2|||<|0.0001||95.0|-4.39|-1.98|||ANCOVA|||||-1.98|-4.39|<0.0001
70973378|NCT00430508|141453431|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.1081||95.0|-2.19|0.22|||ANCOVA|||||0.22|-2.19|0.1081
70973379|NCT00430508|141453432|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.4|||<|0.0001||95.0|-10.13|-4.66|||ANCOVA|||||-4.66|-10.13|<0.0001
70973380|NCT00430508|141453432|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.2|||<|0.0001||95.0|-7.4|-2.91|||ANCOVA|||||-2.91|-7.4|<0.0001
70973381|NCT00430508|141453432|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6||||0.0255||95.0|-4.79|-0.31|||ANCOVA|||||-0.31|-4.79|0.0255
70973382|NCT00430508|141453433|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.6|||<|0.0001||95.0|-9.0|-4.26|||ANCOVA|||||-4.26|-9.00|<0.0001
70973383|NCT00430508|141453433|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.8|||<|0.0001||95.0|-6.7|-2.81|||ANCOVA|||||-2.81|-6.70|<0.0001
70973384|NCT00430508|141453433|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.0812||95.0|-3.66|0.21|||ANCOVA|||||0.21|-3.66|0.0812
70973385|NCT00430508|141453434|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.67||||||95.0|1.69|4.21|||Regression, Logistic|||||4.21|1.69|
70973386|NCT00430508|141453434|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||||95.0|1.5|3.24|||Regression, Logistic|||||3.24|1.50|
70973387|NCT00430508|141453434|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||||95.0|1.07|2.25|||Regression, Logistic|||||2.25|1.07|
70973388|NCT00430508|141453435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.1|||<|0.0001||95.0|-6.78|-3.36|||ANCOVA|||||-3.36|-6.78|<0.0001
71094702|NCT01179516|141697356|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.116||||0.694|TWO_SIDED|95.0|0.646|1.928|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS total score.||||1.928|0.646|0.694
70973389|NCT00430508|141453435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2|||<|0.0001||95.0|-4.54|-1.78|||ANCOVA|||||-1.78|-4.54|<0.0001
70973390|NCT00430508|141453435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.1452||95.0|-2.43|0.36|||ANCOVA|||||0.36|-2.43|0.1452
70973391|NCT00430508|141453436|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.0|||<|0.0001||95.0|-6.79|-3.17|||ANCOVA|||||-3.17|-6.79|<0.0001
70973392|NCT00430508|141453436|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3|||<|0.0001||95.0|-4.79|-1.87|||ANCOVA|||||-1.87|-4.79|<0.0001
70973393|NCT00430508|141453436|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.1629||95.0|-2.52|0.42|||ANCOVA|||||0.42|-2.52|0.1629
70973394|NCT00430508|141453437|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.5|||<|0.0001||95.0|-7.4|-3.62|||ANCOVA|||||-3.62|-7.40|<0.0001
70973395|NCT00430508|141453437|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6|||<|0.0009||95.0|-4.12|-1.07|||ANCOVA|||||-1.07|-4.12|<0.0009
70973396|NCT00430508|141453437|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.1985||95.0|-2.55|0.53|||ANCOVA|||||0.53|-2.55|0.1985
70973397|NCT03728309|141453443|SUPERIORITY||Percentage Difference|53.5|||<|0.001|TWO_SIDED|95.0|43.5|63.5||The p-value and 95% CI are computed by pooling 30 imputed data sets using SAS PROC MIANALYZE with normal approximation.|SAS PROC MIANALYZE|||||63.5|43.5|<0.001
70973398|NCT03728309|141453445|SUPERIORITY||Mean Difference (Final Values)|28.0|STANDARD_ERROR_OF_MEAN|3.83|<|0.001|TWO_SIDED|95.0|21.0|36.0|||2-sample, t-test|||||36.0|21.0|<0.001
70973399|NCT03728309|141453446|SUPERIORITY||Percentage Difference|52.9|||<|0.001|TWO_SIDED|95.0|40.1|65.7|||Fisher's Exact Test||Comparison of treatment group versus control group at Month 1, responder rate difference, 95% CI for risk difference and p-value was estimated based on Fisher's exact test using mITT population with baseline AFLS score of 2 or 3 on both cheeks.|||65.7|40.1|<0.001
70973400|NCT01703858|141453488|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|98.68|STANDARD_DEVIATION|10.0||0|TWO_SIDED|90.0|92.501|105.272|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|B : BI-113608 vs. A : BI-113608 - Comparison with oral solution||105.272|92.501|0.0000
70973401|NCT01703858|141453488|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|70.16|STANDARD_DEVIATION|18.3||0.9644|TWO_SIDED|90.0|62.331|78.962|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|C : BI-113608 vs. B : BI-113608 - Food effect||78.962|62.331|0.9644
70973402|NCT01703858|141453488|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|83.36|STANDARD_DEVIATION|18.8||0.2835|TWO_SIDED|90.0|73.648|94.346|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. B : BI-113608 - Food effect||94.346|73.648|0.2835
70973403|NCT01703858|141453488|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|117.18|STANDARD_DEVIATION|16.7||0.1599|TWO_SIDED|90.0|104.923|130.867|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. C : BI-113608 - Food effect||130.867|104.923|0.1599
70973404|NCT01703858|141453488|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|97.4|STANDARD_DEVIATION|15.8||0.002|TWO_SIDED|90.0|88.072|107.719|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|D : BI-113608 vs. B : BI-113608 - Pantoprazole effect||107.719|88.072|0.0020
70973405|NCT01703858|141453489|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|89.26|STANDARD_DEVIATION|25.3||0.1261|TWO_SIDED|90.0|75.893|104.973|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|B : BI-113608 vs. A : BI-113608 - Comparison with oral solution||104.973|75.893|0.1261
70973406|NCT01703858|141453489|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|54.57|STANDARD_DEVIATION|47.4||0.9808|TWO_SIDED|90.0|40.711|73.157|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|C : BI-113608 vs. B : BI-113608 - Food effect||73.157|40.711|0.9808
70973407|NCT01703858|141453489|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|94.88|STANDARD_DEVIATION|43.2||0.1449|TWO_SIDED|90.0|72.175|124.731|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. B : BI-113608 - Food effect||124.731|72.175|0.1449
70973408|NCT01703858|141453489|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|169.46|STANDARD_DEVIATION|49.7||0.9463|TWO_SIDED|90.0|124.093|231.419|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. C : BI-113608 - Food effect||231.419|124.093|0.9463
71032431|NCT00102440|141573709|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
71032432|NCT00102440|141573709|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
71032433|NCT00102440|141573710|SUPERIORITY_OR_OTHER||||||>|0.999||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||>0.999
71032434|NCT00102440|141573710|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.011
70973409|NCT01703858|141453489|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|81.06|STANDARD_DEVIATION|33.3||0.4564|TWO_SIDED|90.0|65.811|99.848|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|D : BI-113608 vs. B : BI-113608 - Pantoprazole effect||99.848|65.811|0.4564
70973410|NCT01703858|141453490|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|98.66|STANDARD_DEVIATION|9.9||0|TWO_SIDED|90.0|92.5|105.225|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|B : BI-113608 vs. A : BI-113608 - Comparison with oral solution||105.225|92.500|0.0000
70973411|NCT01703858|141453490|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|70.24|STANDARD_DEVIATION|18.3||0.9635|TWO_SIDED|90.0|62.43|79.038|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|C : BI-113608 vs. B : BI-113608 - Food effect||79.038|62.430|0.9635
70973412|NCT01703858|141453490|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|83.46|STANDARD_DEVIATION|18.7||0.2771|TWO_SIDED|90.0|73.774|94.412|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. B : BI-113608 - Food effect||94.412|73.774|0.2771
70973413|NCT01703858|141453490|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|117.16|STANDARD_DEVIATION|16.6||0.1584|TWO_SIDED|90.0|104.958|130.787|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. C : BI-113608 - Food effect||130.787|104.958|0.1584
70973414|NCT01703858|141453490|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|97.41|STANDARD_DEVIATION|15.8||0.002|TWO_SIDED|90.0|88.066|107.741|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|D : BI-113608 vs. B : BI-113608 - Pantoprazole effect||107.741|88.066|0.0020
70973415|NCT01849770|141453520|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.23|STANDARD_ERROR_OF_MEAN|0.4||0.561|TWO_SIDED|95.0|-1.03|0.56|||Random slopes model|||||0.56|-1.03|0.561
71032435|NCT00102440|141573710|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.024
71032436|NCT00102440|141573711|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.083
71032437|NCT00102440|141573711|SUPERIORITY_OR_OTHER|||||||0.164||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.164
71032438|NCT00102440|141573711|SUPERIORITY_OR_OTHER|||||||0.619||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.619
71032439|NCT00102440|141573712|SUPERIORITY_OR_OTHER|||||||0.08||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.080
71032440|NCT00102440|141573712|SUPERIORITY_OR_OTHER|||||||0.372||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.372
71032441|NCT00102440|141573712|SUPERIORITY_OR_OTHER|||||||0.246||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.246
71032442|NCT00102440|141573713|SUPERIORITY_OR_OTHER|||||||0.674||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.674
71032443|NCT00102440|141573713|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.320
70973416|NCT01849770|141453520|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.19|STANDARD_ERROR_OF_MEAN|0.43||0.662|TWO_SIDED|95.0|-1.04|0.66|||Random slopes model|||||0.66|-1.04|0.662
70973417|NCT01849770|141453521|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.71|STANDARD_ERROR_OF_MEAN|1.25||0.178|TWO_SIDED|95.0|-0.8|4.22|||Random slopes model|||||4.22|-0.80|0.178
70973418|NCT01849770|141453521|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.94|STANDARD_ERROR_OF_MEAN|1.42||0.51|TWO_SIDED|95.0|-3.8|1.91|||Random slopes model|||||1.91|-3.80|0.510
70973419|NCT00993031|141453527|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.83||||0.76|TWO_SIDED|95.0|0.26|2.67|||Chi-squared|||||2.67|.26|.76
70973420|NCT00993031|141453528|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.85||||0.76|TWO_SIDED|95.0|0.29|2.46|||Chi-squared|||||2.46|.29|.76
70973421|NCT00993031|141453529|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75||||0.45|TWO_SIDED|95.0|0.36|1.59|||Chi-squared|||||1.59|.36|.45
70973422|NCT00993031|141453531|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.22||||0.21|TWO_SIDED|95.0|0.89|1.66|||Chi-squared|||||1.66|.89|.21
70973423|NCT00993031|141453532|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.34||||0.06|TWO_SIDED|95.0|0.98|1.83|||Chi-squared|||||1.83|.98|.06
70973424|NCT04673786|141453574|EQUIVALENCE|Predefined equivalence margin: -10% to 10%|Treatment difference (%) and 90% CI|2.05|||||TWO_SIDED|90.0|-0.23|4.32|||ANCOVA|Multiple imputation (MI) with the Missing at random (MAR) assumption was applied.||||4.32|-0.23|
70973425|NCT02682901|141453583|SUPERIORITY|||||||0.603||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means are statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.603
70973426|NCT02682901|141453584|SUPERIORITY|||||||0.068||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means are statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.068
70973427|NCT02682901|141453585|SUPERIORITY|||||||0.493||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means are statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.493
70973428|NCT02682901|141453586|SUPERIORITY|||||||0.524||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means were statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.524
70973429|NCT02682901|141453587|SUPERIORITY|||||||0.63||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means were statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.630
70973430|NCT02682901|141453588|SUPERIORITY|||||||0.537||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means were statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.537
70973431|NCT02682901|141453589|SUPERIORITY|||||||0.53||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means were statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.530
70973432|NCT02682901|141453590|SUPERIORITY|||||||0.005||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means were statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.005
70973433|NCT01097304|141453649|OTHER|||||||0.54|||||||t-test, 2 sided|||||||0.54
70973434|NCT01097304|141453650|OTHER||||||<|0.0001|||||||signed rank test|||||||<0.0001
70973435|NCT01097304|141453651|OTHER||||||<|0.01|||||||signed rank test|||||||<0.01
70973436|NCT01097304|141453652|OTHER|||||||0.48|||||||t-test, 2 sided|||||||0.48
70973437|NCT02573155|141453667|SUPERIORITY_OR_OTHER||Least Square Mean|0.111|STANDARD_ERROR_OF_MEAN|0.0265|<|0.0001|TWO_SIDED|95.0|0.0585|0.163|||ANCOVA|||||0.163|0.0585|<0.0001
70973438|NCT02573155|141453667|SUPERIORITY_OR_OTHER||Least square mean|0.21|STANDARD_ERROR_OF_MEAN|0.0272|<|0.0001||95.0|0.156|0.264|||ANCOVA|||||0.264|0.156|<0.0001
70973439|NCT02301403|141453681|SUPERIORITY||Odds Ratio (OR)|2.95|||<|0.001|TWO_SIDED|95.0|1.69|5.14|||Regression, Logistic|||||5.14|1.69|<.001
70973440|NCT02189850|141453682|SUPERIORITY|||||||0.923|||||||Cochran-Mantel-Haenszel|||||||0.923
70973441|NCT03505021|141453696|SUPERIORITY||Mean Difference (Final Values)|0.258||||0.8253|TWO_SIDED|95.0|-2.032|2.547|||ANCOVA|||||2.547|-2.032|0.8253
70973442|NCT03505021|141453697|SUPERIORITY||Mean Difference (Final Values)|10.69||||0.4277|TWO_SIDED|95.0|-15.74|37.12|||ANCOVA|||||37.12|-15.74|0.4277
70973443|NCT03505021|141453698|SUPERIORITY||Hazard Ratio (HR)|1.051||||0.6733|TWO_SIDED|95.0|0.833|1.327|||Regression, Cox|||||1.327|0.833|0.6733
70973444|NCT03505021|141453699|SUPERIORITY||Mean Difference (Final Values)|3.762||||0.1295|TWO_SIDED|95.0|-1.129|8.654|||ANCOVA|||||8.654|-1.129|0.1295
70973445|NCT03505021|141453700|SUPERIORITY||Mean Difference (Final Values)|0.013||||0.623|TWO_SIDED|95.0|-0.04|0.066|||Mixed Models Analysis|||||0.066|-0.040|0.6230
70973446|NCT03505021|141453701|SUPERIORITY||Mean Difference (Final Values)|-0.272||||0.1752|TWO_SIDED|95.0|-0.666|0.122|||ANCOVA|||||0.122|-0.666|0.1752
70973447|NCT00741156|141453707|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.09
70973448|NCT02762513|141453712|OTHER||Median overall survival time (months)|9.8|||||TWO_SIDED|95.0|||||||Median calculated by Kaplan-Meier method.|||||
70973449|NCT02762513|141453713|OTHER||Median PFS time (months)|3.5|||||TWO_SIDED|95.0|||||||Median calculated by Kaplan-Meier method.|||||
71032444|NCT00102440|141573713|SUPERIORITY_OR_OTHER|||||||0.411||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.411
71032445|NCT00102440|141573714|SUPERIORITY_OR_OTHER|||||||0.507||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.507
71032446|NCT00102440|141573714|SUPERIORITY_OR_OTHER|||||||0.188||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.188
70973450|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|849.0|||<|0.0001|TWO_SIDED|95.0|786.0|921.0||Adjusted Cost Differences in Prescription Drug Costs, AEDs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||921|786|<0.0001
70973451|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1879.0|||<|0.0001|TWO_SIDED|95.0|1636.0|2112.0||Adjusted Cost Differences in Prescription Drug Costs, nonAEDs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||2112|1636|<0.0001
70973452|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5681.0|||<|0.0001|TWO_SIDED|95.0|5257.0|6077.0||Adjusted Cost Differences in Hospitalizations, All Medical Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||6077|5257|<0.0001
70973453|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|273.0|||<|0.0001|TWO_SIDED|95.0|251.0|295.0||Adjusted Cost Differences in Emergency Department Visits, All Medical Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||295|251|<0.0001
70973454|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1021.0|||<|0.0001|TWO_SIDED|95.0|819.0|1211.0||Adjusted Cost Differences in Outpatient Services, All Medical Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||1211|819|<0.0001
70973455|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|60.0|||<|0.0001|TWO_SIDED|95.0|48.0|72.0||Adjusted Cost Differences in Neurologist Visits, All Medical Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||72|48|<0.0001
70973456|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2555.0||||0.008|TWO_SIDED|95.0|834.0|4281.0||Adjusted Cost Differences in Other Healthcare Services, All Medical Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||4281|834|0.0080
70973457|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4041.0|||<|0.0001|TWO_SIDED|95.0|3776.0|4305.0||Adjusted Cost Differences in Epilepsy-Related Hospitalizations|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||4305|3776|<0.0001
70973458|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|105.0|||<|0.0001|TWO_SIDED|95.0|97.0|114.0||Adjusted Cost Differences in Epilepsy-Related Emergency Department Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||114|97|<0.0001
70973459|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|384.0|||<|0.0001|TWO_SIDED|95.0|358.0|413.0||Adjusted Cost Differences in Epilepsy-Related Outpatient Services|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||413|358|<0.0001
70973460|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.0|||<|0.0001|TWO_SIDED|95.0|40.0|56.0||Adjusted Cost Differences in Epilepsy-Related Neurologist Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||56|40|<0.0001
70973461|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|892.0|||<|0.0001|TWO_SIDED|95.0|584.0|1192.0||Adjusted Cost Differences in Other Epilepsy-Related Healthcare Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||1192|584|<0.0001
70973462|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|12258.0|||<|0.0001|TWO_SIDED|95.0|10482.0|14083.0||Adjusted Cost Differences in Total Healthcare Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||14083|10482|<0.0001
70973463|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|322.0|||<|0.0001|TWO_SIDED|95.0|245.0|398.0||Adjusted Cost Differences in Prescription Drug Costs, AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||398|245|<0.0001
71032447|NCT00102440|141573714|SUPERIORITY_OR_OTHER|||||||0.362||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.362
71032448|NCT00102440|141573715|SUPERIORITY_OR_OTHER|||||||0.657||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.657
71032449|NCT00102440|141573715|SUPERIORITY_OR_OTHER|||||||0.444||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.444
70973464|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|841.0|||<|0.0001|TWO_SIDED|95.0|556.0|1078.0||Adjusted Cost Differences in Prescription Drug Costs, non-AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||1078|556|<0.0001
70973465|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3248.0|||<|0.0001|TWO_SIDED|95.0|2790.0|3714.0||Adjusted Cost Differences in Hospitalizations, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||3714|2790|<0.0001
70973466|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|164.0|||<|0.0001|TWO_SIDED|95.0|138.0|190.0||Adjusted Cost Differences in Emergency Department Visits, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||190|138|<0.0001
70973467|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|628.0|||<|0.0001|TWO_SIDED|95.0|409.0|819.0||Adjusted Cost Differences in Outpatient Services, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||819|409|<0.0001
70973468|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.0|||<|0.0001|TWO_SIDED|95.0|18.0|42.0||Adjusted Cost Differences in Neurologist Visits, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||42|18|<0.0001
70973469|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|235.0||||0.7628|TWO_SIDED|95.0|-1367.0|1798.0||Adjusted Cost Differences in Other Healthcare Services, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||1798|-1367|0.7628
70973470|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2306.0|||<|0.0001|TWO_SIDED|95.0|2016.0|2603.0||Adjusted Cost Differences in Epilepsy-Related Hospitalizations|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||2603|2016|<0.0001
70973471|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|63.0|||<|0.0001|TWO_SIDED|95.0|52.0|74.0||Adjusted Cost Differences in Epilepsy-Related Emergency Department Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||74|52|<0.0001
70973472|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|211.0|||<|0.0001|TWO_SIDED|95.0|179.0|245.0||Adjusted Cost Differences in Epilepsy-Related Outpatient Services|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||245|179|<0.0001
70973473|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.0|||<|0.0001|TWO_SIDED|95.0|15.0|33.0||Adjusted Cost Differences in Epilepsy-Related Neurologist Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||33|15|<0.0001
70973474|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|277.0||||0.0581|TWO_SIDED|95.0|-19.0|581.0||Adjusted Cost Differences in Other Epilepsy-Related Healthcare Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||581|-19|0.0581
70973475|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5437.0|||<|0.0001|TWO_SIDED|95.0|3672.0|7142.0||Adjusted Cost Differences in Total Healthcare Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||7142|3672|<0.0001
70973476|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1019.0|||<|0.0001|TWO_SIDED|95.0|836.0|1191.0||Adjusted Cost Differences in Prescription Drug Costs, AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||1191|836|<0.0001
70973477|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1047.0|||<|0.0001|TWO_SIDED|95.0|564.0|1486.0||Adjusted Cost Differences in Prescription Drug Costs, Non-AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||1486|564|<0.0001
70973478|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|9128.0|||<|0.0001|TWO_SIDED|95.0|7346.0|11125.0||Adjusted Cost Differences in Hospitalizations|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||11125|7346|<0.0001
70973479|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|459.0|||<|0.0001|TWO_SIDED|95.0|326.0|622.0||Adjusted Cost Differences in Emergency Department Visits|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||622|326|<0.0001
70973480|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2427.0|||<|0.0001|TWO_SIDED|95.0|1587.0|3290.0||Adjusted Cost Differences in Outpatient Services|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||3290|1587|<0.0001
71032450|NCT00102440|141573715|SUPERIORITY_OR_OTHER|||||||0.719||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.719
71032451|NCT00102440|141573716|SUPERIORITY_OR_OTHER||||||>|0.999||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||>0.999
71032452|NCT00102440|141573716|SUPERIORITY_OR_OTHER|||||||0.229||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.229
71094703|NCT01179516|141697357|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|1.25||0.464|TWO_SIDED|95.0|-3.38|1.55|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||1.55|-3.38|0.464
71094704|NCT01179516|141697357|SUPERIORITY_OR_OTHER||LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|1.322||0.6|TWO_SIDED|95.0|-1.91|3.3|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||3.30|-1.91|0.600
71094705|NCT02337946|141697385|SUPERIORITY||Difference of PFS rate between groups|0.9|||||TWO_SIDED|95.0|-17.2|19.0|||||||Agresti-Caffo method was used for estimation of 95% CI.|19.0|-17.2|
71094706|NCT02337946|141697386|SUPERIORITY||Adjusted Hazard Ratio (HR)|0.93||||0.7349|TWO_SIDED|95.0|0.6|1.43|||Regression, Multivariable Cox|The Cox regression model was adjusted by stratification factors except for study sites.||||1.43|0.60|0.7349
71094707|NCT02337946|141697387|SUPERIORITY||Adjusted Hazard Ratio (HR)|1.41||||0.3485|TWO_SIDED|95.0|0.69|2.88|||Regression, Multivariable Cox|The Cox regression model was adjusted by stratification factors except for study sites.||||2.88|0.69|0.3485
71094708|NCT02337946|141697389|SUPERIORITY||Multivariable Hazard Ratio (HR)|0.9||||0.5901|TWO_SIDED|95.0|0.6|1.33|||Regression, Multivariable Cox|The Cox regression model was adjusted by stratification factors except for study sites.||||1.33|0.60|0.5901
71094709|NCT02949934|141697407|SUPERIORITY|||||||0.013|||||||ANCOVA|Covariates were age, baseline AUDIT score, baseline drinks per day, and whether participant participated before vs. during the COVID-19 pandemic.||Analysis was an ANCOVA testing the interaction between rs4680 genotype and medication group.||||0.013
70920612|NCT00520546|141331975|SUPERIORITY_OR_OTHER||sensitivity|97.0||||0.0526|TWO_SIDED|95.0|86.0|100.0|||Fisher Exact|||"results from FEC-PET as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||100|86|0.0526
71094710|NCT02949934|141697408|SUPERIORITY|||||||0.014|||||||ANCOVA|Covariates were age, baseline AUDIT score, and baseline drinks per day.||Analysis was an ANCOVA testing the interaction between rs4680 genotype and medication group||||0.014
71094711|NCT02949934|141697409|SUPERIORITY|||||||0.062|||||||Mixed Models Analysis|Linear mixed model testing interaction between rs4680 genotype, medication group, and time, controlling for scanner||||||0.062
71094712|NCT02949934|141697410|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|Linear mixed model testing interaction between rs4680 genotype, medication group, and time, controlling for scanner||||||0.83
71094713|NCT02949934|141697410|SUPERIORITY|||||||0.026|||||||Mixed Models Analysis|Linear mixed model testing interaction between medication group and time, controlling for scanner||||||0.026
70920613|NCT00520546|141331975|SUPERIORITY_OR_OTHER||specificity|0.0||||0.0526|TWO_SIDED|95.0|0.0|98.0|||Fisher Exact|||"results from FEC-PET as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||98|0|0.0526
70920614|NCT00520546|141331975|SUPERIORITY_OR_OTHER||accuracy|95.0||||0.0526|TWO_SIDED|95.0|82.0|99.0|||Fisher Exact|||"results from FEC-PET as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||99|82|0.0526
70973481|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|357.0|||<|0.0001|TWO_SIDED|95.0|225.0|525.0||Adjusted Cost Differences in Neurologists Visits|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||525|225|<0.0001
70973482|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|502.0|||<|0.0001|TWO_SIDED|95.0|234.0|768.0||Adjusted Cost Differences in Other Healthcare Services|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||768|234|<0.0001
71094714|NCT01590875|141697426|EQUIVALENCE|Kappa statistics on per pulmonary vein basis were used to determine the probability of recovery, transient recovery or no recovery with second adenosine dose compared with probability of same response after first adenosine dose|||||<|0.01|||||||no relevant statistical analysis|||Kappa statistics on per pulmonary vein basis were used to determine the probability of recovery, transient recovery or no recovery with second adenosine dose compared with probability of same response after first adenosine dose||||<0.01
71094715|NCT01590875|141697427|EQUIVALENCE|Kappa statistics on per pulmonary vein basis were used to determine the probability of recovery, transient recovery or no recovery with second adenosine dose compared with probability of same response after first adenosine dose|||||<|0.01|||||||kappa statistic|||Kappa statistics on per pulmonary vein basis were used to determine the probability of recovery, transient recovery or no recovery with second adenosine dose compared with probability of same response after first adenosine dose||||< 0.01
70920615|NCT00520546|141331975|SUPERIORITY_OR_OTHER||sensitivity|70.0|||<|0.0001|TWO_SIDED|95.0|53.0|84.0|||Fisher Exact|||"results from MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||84|53|<0.0001
70920616|NCT00520546|141331975|SUPERIORITY_OR_OTHER||specificity|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|98.0|||Fisher Exact|||"results from MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||98|0|<0.0001
71094716|NCT01214720|141697431|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0002|TWO_SIDED|95.0|0.61|0.86|||Log Rank|||||0.86|0.61|0.0002
71094717|NCT01214720|141697432|SUPERIORITY_OR_OTHER||Difference in Response Rates|3.62||||0.3621|TWO_SIDED|95.0|-4.3|11.6|||Chi-squared|Approximate 95% confidence interval (CI) for difference of two rates using Hauck-Anderson method.||||11.6|-4.3|0.3621
71094718|NCT01214720|141697433|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.2087||95.0|0.74|1.07|||Log Rank|||||1.07|0.74|0.2087
70920617|NCT00520546|141331975|SUPERIORITY_OR_OTHER||accuracy|68.0|||<|0.0001|TWO_SIDED|95.0|51.0|83.0|||Fisher Exact|||"results from MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||83|51|<0.0001
70920618|NCT00520546|141331975|SUPERIORITY_OR_OTHER||sensitivity|95.0||||0.0043|TWO_SIDED|95.0|82.0|99.0|||Fisher Exact|||"results from PET/MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||99|82|0.0043
70973483|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6483.0|||<|0.0001|TWO_SIDED|95.0|5329.0|7927.0||Adjusted Cost Differences in Epilepsy-Related Hospitalizations|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||7927|5329|<0.0001
70973484|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|150.0|||<|0.0001|TWO_SIDED|95.0|112.0|199.0||Adjusted Cost Differences in Epilepsy-Related Emergency Department Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||199|112|<0.0001
70973485|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|516.0|||<|0.0001|TWO_SIDED|95.0|401.0|645.0||Adjusted Cost Differences in Epilepsy-Related Outpatient Services|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||645|401|<0.0001
70973486|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|158.0|||<|0.0001|TWO_SIDED|95.0|97.0|231.0||Adjusted Cost Differences in Epilepsy-Related Neurologist Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||231|97|<0.0001
71032453|NCT00102440|141573716|SUPERIORITY_OR_OTHER|||||||0.266||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.266
71032454|NCT02255097|141573717|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||exact binomial distribution|null hypothesis (H0): p ≤ 0.05 versus alternate hypothesis (H1): p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||<0.001
71094719|NCT02347787|141697435|SUPERIORITY|||||||0.3|||||||Regression, Linear|||Determination of targeted sample size was based on detecting a between-arm difference in mean change in SF-12 Physical Component Summary of 3 points, which is the minimal clinically significant difference for this instrument. To achieve at least 80% power with a type I error rate of 5%, we required 444 total participants. To account for 25% attrition, we aimed to accrue 592 participants.||||0.30
71094720|NCT02347787|141697436|SUPERIORITY||Risk Difference (RD)|-0.2||||0.21|TWO_SIDED|95.0|-1.3|0.9|||Regression, Linear|||||0.9|-1.3|0.21
71094721|NCT02347787|141697437|SUPERIORITY||Risk Difference (RD)|-0.2||||0.21|TWO_SIDED|95.0|-0.7|0.4|||Regression, Linear|||||0.4|-0.7|0.21
71094722|NCT02347787|141697438|SUPERIORITY||Risk Difference (RD)|-0.5||||0.21|TWO_SIDED|95.0|-2.2|1.2|||Regression, Linear|||||1.2|-2.2|0.21
70973487|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|83.0|||<|0.0001|TWO_SIDED|95.0|58.0|113.0||Adjusted Cost Differences in Other Epilepsy-Related Healthcare Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||113|58|<0.0001
70973488|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14582.0|||<|0.0001|TWO_SIDED|95.0|12019.0|17097.0||Adjusted Cost Differences in Total Healthcare Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||17097|12019|<0.0001
71032455|NCT02255097|141573718|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||<0.001
71032456|NCT02255097|141573721|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||<0.001
71032457|NCT02255097|141573722|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0027|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||0.0027
71032458|NCT02255097|141573723|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||<0.001
71032459|NCT02255097|141573724|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||<0.001
71032460|NCT02255097|141573725|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||<0.001
71032461|NCT02129426|141573780|OTHER|t-test comparison of the two groups||||||0.96|||||||t-test, 1 sided|||||||0.96
71032462|NCT02129426|141573781|OTHER|||||||0.52|||||||t-test, 1 sided|||||||0.52
71094723|NCT02347787|141697439|SUPERIORITY||Risk Difference (RD)|-6.3||||0.21|TWO_SIDED|95.0|-14.3|1.8|||Regression, Linear|||||1.8|-14.3|0.21
71094724|NCT02347787|141697440|SUPERIORITY|||||||0.41|||||||Regression, Linear|||||||0.41
71094725|NCT02347787|141697441|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71094726|NCT02347787|141697442|SUPERIORITY||Odds Ratio (OR)|1.0||||0.98|TWO_SIDED|95.0|0.6|1.5|||Regression, Logistic|||||1.5|0.6|0.98
71094727|NCT02347787|141697444|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71094728|NCT02347787|141697445|SUPERIORITY|||||||0.02|||||||Regression, Logistic|||||||0.02
71094729|NCT02347787|141697446|SUPERIORITY|||||||0.04|||||||Regression, Logistic|||||||0.04
71032463|NCT00850174|141573830|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.48||||||90.0|88.98|109.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109.00|88.98|
70973489|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|420.0|||<|0.0001|TWO_SIDED|95.0|210.0|630.0||Adjusted Cost Differences in Prescription Drug Costs, AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||630|210|<0.0001
70973490|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|658.0|||<|0.0001|TWO_SIDED|95.0|217.0|1131.0||Adjusted Cost Differences in Prescription Drug Costs, Non-AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||1131|217|<0.0001
70973491|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6040.0|||<|0.0001|TWO_SIDED|95.0|3442.0|8795.0||Adjusted Cost Differences in Hospitalizations, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||8795|3442|<0.0001
70973492|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|268.0||||0.002|TWO_SIDED|95.0|81.0|425.0||Adjusted Cost Differences in Emergency Department Visits, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||425|81|0.0020
71032464|NCT00850174|141573831|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|102.54||||||90.0|99.19|106.01|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.01|99.19|
71032465|NCT00850174|141573832|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|102.19||||||90.0|98.78|105.71|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.71|98.78|
71032466|NCT00850174|141573833|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|100.77||||||90.0|97.03|104.65|||||Results presented for informational purposes only; metabolite not subjected to Bioequivalence criteria.|||104.65|97.03|
71032467|NCT00850174|141573834|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|99.94||||||90.0|97.75|102.18|||||Results presented for informational purposes only, metabolite not subjected to bioequivalence criteria.|||102.18|97.75|
71032468|NCT00850174|141573835|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|99.8||||||90.0|97.5|102.15|||||Results presented for informational purposes only; metabolite not subjected to bioequivalence criteria.|||102.15|97.50|
71032469|NCT00635492|141573837|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16|||<|0.0001|TWO_SIDED|95.0|1.13|1.19|||Regression, Logistic|||Body Mass Index (BMI) - 1kg/m² higher||1.19|1.13|<0.0001
70973493|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.0||||0.967|TWO_SIDED|95.0|-991.0|944.0||Adjusted Cost Differences in Outpatient Services, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||944|-991|0.9670
70973494|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|97.0||||0.2563|TWO_SIDED|95.0|-77.0|302.0||Adjusted Cost Differences in Neurologist Visits, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||302|-77|0.2563
70973495|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|328.0||||0.01|TWO_SIDED|95.0|90.0|588.0||Adjusted Cost Differences in Other Healthcare Services, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||588|90|0.0100
71032470|NCT00635492|141573838|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77|||<|0.0001|TWO_SIDED|95.0|0.69|0.86|||Regression, Logistic|||Most recent HbA1c at baseline - 1% higher.||0.86|0.69|<0.0001
71032471|NCT00635492|141573839|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96|||<|0.0001|TWO_SIDED|95.0|0.95|0.97|||Regression, Logistic|||Age - 1 year older||0.97|0.95|<0.0001
71032472|NCT00635492|141573840|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.0083|TWO_SIDED|95.0|1.01|1.1|||Regression, Logistic|||Diabetes Health Profile - 18 (DHP-18) subscale disinhibited eating - Yes vs. No||1.10|1.01|0.0083
71032473|NCT00635492|141573841|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.0141|TWO_SIDED|95.0|0.9|0.99|||Regression, Logistic|||Random blood glucose - 1 mmol/L higher||0.99|0.90|0.0141
71032474|NCT00635492|141573842|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.0107|TWO_SIDED|95.0|0.96|0.99|||Regression, Logistic|||Blood glucose self-monitoring - 1 test/week more||0.99|0.96|0.0107
71032475|NCT00635492|141573843|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.0193|TWO_SIDED|95.0|1.13|2.46|||Regression, Logistic|||Receipt of diet/exercise advice - Yes vs. No||2.46|1.13|0.0193
71032476|NCT00635492|141573844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.0138|TWO_SIDED|95.0|0.72|0.96|||Regression, Logistic|||LDL cholesterol - 1 mmol/L higher at baseline||0.96|0.72|0.0138
71032477|NCT00635492|141573852|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.118|||<|0.0001|TWO_SIDED|95.0|1.062|1.177|||Regression, Cox|||HbA1c (%) at baseline||1.177|1.062|<0.0001
71032478|NCT00635492|141573852|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.001|TWO_SIDED|95.0|0.937|0.985|||Regression, Cox|||DHP barriers to activity subscale at baseline||0.985|0.937|0.001
71094730|NCT02347787|141697448|SUPERIORITY|||||||0.09|||||||Regression, Linear|||||||0.09
71094731|NCT02347787|141697449|SUPERIORITY|||||||0.06|||||||Regression, Linear|||||||0.06
71094732|NCT03720847|141697450|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.012|TWO_SIDED||||||t-test, 2 sided|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.|Positive estimated value indicates greater perimenstrual increase in symptoms in the placebo condition relative to the active condition.|||||.012
70973496|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4984.0|||<|0.0001|TWO_SIDED|95.0|3168.0|7335.0||Adjusted Cost Differences in Hospitalizations, Epilepsy-Related|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||7335|3168|<0.0001
70973497|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|112.0|||<|0.0001|TWO_SIDED|95.0|70.0|166.0||Adjusted Cost Differences in Emergency Department Visits, Epilepsy-Related|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||166|70|<0.0001
70973498|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|236.0||||0.01|TWO_SIDED|95.0|70.0|403.0||Adjusted Cost Differences in Outpatient Services, Epilepsy-Related|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||403|70|0.01
70973499|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|65.0||||0.1061|TWO_SIDED|95.0|-22.0|145.0||Adjusted Cost Differences in Neurologist Visits, Epilepsy-Related|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||145|-22|0.1061
70973500|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|58.0|||<|0.0001|TWO_SIDED|95.0|28.0|93.0||Adjusted Cost Differences in Other Healthcare Services, Epilepsy-Related|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||93|28|<0.0001
70973501|NCT01390909|141453716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7673.0|||<|0.0001|TWO_SIDED|95.0|4571.0|10989.0||Adjusted Cost Differences in Total Healthcare Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||10989|4571|<0.0001
70973502|NCT05022641|141453769|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||.6
70973503|NCT05022641|141453770|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|||||||.65
70973504|NCT05022641|141453771|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||.02
70973505|NCT05022641|141453772|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.6
70973506|NCT05022641|141453774|SUPERIORITY|||||||0.6|||||||Chi-squared|||||||.6
70973507|NCT02653768|141453779|OTHER|As noted above, a statistical test was not specified at this time point. Rather, the data for all time points were included in the model and are presented here descriptively.|Mean Difference (Final Values)|-5.1|||||TWO_SIDED|95.0|-8.2|-2.0||||||This analysis of between-group difference in change from baseline to 3-month follow-up. We have not included a p-value because there was no pre-specified hypothesis for this time point. Rather, these are additional data obtained from the overall model, for which the 9-month time point was primary and included a pre-specified hypothesis.||-2.0|-8.2|
71032479|NCT00635492|141573852|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.532|||<|0.001|TWO_SIDED|95.0|1.698|3.777|||Regression, Cox|||Gastrointestinal symptoms: yes vs. no at baseline||3.777|1.698|<0.001
71032480|NCT00635492|141573852|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.437|||<|0.001|TWO_SIDED|95.0|0.303|0.63|||Regression, Cox|||Insulin regimen: basal/bolus vs. long-acting only||0.630|0.303|<0.001
71032481|NCT00635492|141573852|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.676||||0.003|TWO_SIDED|95.0|0.523|0.874|||Regression, Cox|||Insulin regimen: mixtures vs. long-acting only||0.874|0.523|0.003
70973508|NCT02653768|141453779|OTHER|As noted above, a statistical test was not specified at this time point. Rather, the data for all time points were included in the model and are presented here descriptively.|Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-5.2|2.3||||||This is the analysis of between-group difference in change from baseline to 6-month follow-up. We have not included a p-value because there was no pre-specified hypothesis for this time point. Rather, these are additional data obtained from the overall model, for which the 9-month time point was primary and included a pre-specified hypothesis.||2.3|-5.2|
71032482|NCT00635492|141573852|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.549||||0.303|TWO_SIDED|95.0|0.175|1.718|||Regression, Cox|||Insulin regimen: other vs. long-acting only||1.718|0.175|0.303
70973509|NCT02653768|141453779|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.0003|TWO_SIDED|95.0|-10.5|-3.2|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 9-month follow-up. This is the primary outcome assessment time point.||-3.2|-10.5|0.0003
70973510|NCT02653768|141453780|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.43|TWO_SIDED|95.0|-0.6|1.3|||Mixed Models Analysis|||This is the analysis between-group difference in change from baseline to 9-month follow-up for the 30 second chair stand.||1.3|-0.6|0.43
70973511|NCT02653768|141453781|OTHER||Mean Difference (Final Values)|-2.3||||0.23|TWO_SIDED|95.0|-6.1|1.5|||Mixed Models Analysis|||||1.5|-6.1|0.23
70973512|NCT05218499|141453791|OTHER||Hazard Ratio (HR)|0.79||||0.0956|TWO_SIDED|95.0|0.6|1.06|||Regression, Cox||A hazard ratio value below 1 favors brigimadlin.|The primary estimator for the hazard ratio is the median unbiased estimator. The confidence interval (CI) for the hazard ratio is calculated as a repeated CI. The p-value is obtained using a weighted inverse normal method combining one-sided p-values from two stages.||1.06|0.60|0.0956
70973513|NCT05218499|141453792|OTHER||Odds Ratio (OR)|2.93|||||TWO_SIDED|95.0|1.52|5.67|||||An odds ratio value greater than 1 favors brigimadlin.|The primary estimator and CI for the odds ratio is by Cochran-Mantel-Haenszel.||5.67|1.52|
71032483|NCT00635492|141573852|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.164|||<|0.001|TWO_SIDED|95.0|1.681|2.785|||Regression, Cox|||Insulin regimen: short-acting only vs. long-acting only||2.785|1.681|<0.001
71032484|NCT00635492|141573853|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.463||||0.028|TWO_SIDED|95.0|1.043|2.053|||Regression, Cox|||GI symptoms: yes vs. no at baseline||2.053|1.043|0.028
71032485|NCT00635492|141573853|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.601||||0.002|TWO_SIDED|95.0|0.432|0.834|||Regression, Cox|||EQ-5D index value at baseline||0.834|0.432|0.002
71032486|NCT05169710|141573890|SUPERIORITY||Mean Difference (Final Values)|-3.94|STANDARD_ERROR_OF_MEAN|2.857||0.1718|TWO_SIDED|95.0|-9.64|1.75|||Mixed Models Analysis|||||1.75|-9.64|0.1718
71032487|NCT05169710|141573890|SUPERIORITY||Mean Difference (Final Values)|-6.34|STANDARD_ERROR_OF_MEAN|2.837||0.0286|TWO_SIDED|95.0|-11.99|-0.68|||Mixed Models Analysis|||||-0.68|-11.99|0.028600
71032488|NCT05169710|141573891|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.308||0.7314|TWO_SIDED|95.0|-0.72|0.51|||Mixed Models Analysis|||||0.51|-0.72|0.7314
70973514|NCT05218499|141453794|OTHER||Odds Ratio (OR)|1.51|||||TWO_SIDED|95.0|0.81|2.82|||||An odds ratio value greater than 1 favors brigimadlin.|Odds ratios are calculated from a logistic regression model with the stratification factor (locally advanced vs. metastatic) included as a covariate.||2.82|0.81|
70973515|NCT05218499|141453794|OTHER||Odds Ratio (OR)|2.67|||||TWO_SIDED|95.0|1.48|4.84|||||An odds ratio value greater than 1 favors brigimadlin.|Odds ratios are calculated from a logistic regression model with the stratification factor (locally advanced vs. metastatic) included as a covariate. Exact 95% confidence interval (CI) by Clopper and Pearson.||4.84|1.48|
70973516|NCT03237065|141453832|SUPERIORITY||Risk Difference (RD)|-65.8|||<|0.0001|TWO_SIDED|95.0|-76.6|-49.8|||Cochran-Mantel-Haenszel|Rate difference with 95% Newcombe confidence intervals (CI) adjusted for stratum, using the Cochran-Mantel-Haenszel method.|Iron isomaltoside/ferric derisomaltose was compared to ferric carboxymaltose by estimation of the risk difference and the associated 95% CI, adjusting for strata (underlying disease and screening s-phosphate) using the Cochran-Mantel-Haenszel method.|"Power:~The power was set to 80%. Assuming incidences of 15% for iron isomaltoside/ferric derisomaltose and 40% for ferric carboxymaltose, 49 subjects in each treatment group were required to detect a difference between the treatment groups. The significance level was set to 5%."||-49.8|-76.6|<0.0001
71032489|NCT05169710|141573891|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.305||0.3169|TWO_SIDED|95.0|-0.91|0.3|||Mixed Models Analysis|||||0.3|-0.91|0.3169
71032490|NCT02729714|141573893|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
71032491|NCT02729714|141573894|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||0.51
71032492|NCT02729714|141573895|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||||||0.81
71032493|NCT02729714|141573896|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
71032494|NCT02729714|141573897|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
71032495|NCT02729714|141573898|SUPERIORITY|||||||0.098|||||||Wilcoxon (Mann-Whitney)|||||||0.098
71032496|NCT02729714|141573899|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
71032497|NCT01686438|141573909|NON_INFERIORITY|The mean change in ISI score from baseline in Veterans receiving CBT-I by video teleconferencing will be no more than 1.67 smaller than the reference treatment, i.e., Veterans receiving in-person CBT-I.|Mean Difference (Net)|-2.03|STANDARD_DEVIATION|1.33||0.138|TWO_SIDED|95.0|-4.63|1.57|||t-test, 1 sided|||||1.57|-4.63|0.138
71032498|NCT06358820|141573930|SUPERIORITY|\>0.15 g/dL change in albumin from baseline to month 6 was anticipated.|Mean Difference (Final Values)|3.77|||<|0.0125|TWO_SIDED|95.0|3.15|4.39||A 2-sided P value less than 0.05 was considered statistically significant. However, the significance level (α) was adjusted to 0.0125 to account for multiple testing.|ANOVA||The main analysis was based on LOCF for missing value.|Outcome Measure were assessed at baseline and every month during the 6-month study.||4.39|3.15|<0.0125
71032499|NCT06358820|141573931|SUPERIORITY|\>60 mg/L change in prealbumin from baseline to month 6.|Mean Difference (Net)|39.77||||0.0125|TWO_SIDED|95.0|26.66|56.87||A 2-sided P value less than 0.05 was considered statistically significant. However, the significance level (α) was adjusted to 0.0125 to account for multiple testing.|ANOVA||The main analysis was based on LOCF for missing value.|||56.87|26.66|0.0125
71032500|NCT01124175|141573932|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|111.95|||||TWO_SIDED|90.0|101.84|123.06|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||123.06|101.84|
71032501|NCT01124175|141573933|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|105.97|||||TWO_SIDED|90.0|103.61|108.39|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.39|103.61|
71032502|NCT01124175|141573934|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|105.67|||||TWO_SIDED|90.0|103.32|108.07|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.07|103.32|
71032503|NCT01124175|141573935|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|105.97|||||TWO_SIDED|90.0|101.22|110.93|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||110.93|101.22|
71032504|NCT01124175|141573936|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|103.07|||||TWO_SIDED|90.0|100.9|105.28|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||105.28|100.90|
71032505|NCT01124175|141573937|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|102.36|||||TWO_SIDED|90.0|100.41|104.34|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104.34|100.41|
70973517|NCT03237065|141453833|SUPERIORITY|||||||0.0511|||||||Log Rank|||The time with hypophosphatemia from baseline to day 35 was estimated by a Kaplan- Meier plot. The treatment groups were compared by a log-rank test. Only subjects who had one or more s-phosphate value(s) \<2 mg/dL were included.||||0.0511
70973518|NCT03237065|141453834|SUPERIORITY||Risk Difference (RD)|-44.6|||<|0.0001|TWO_SIDED|95.0|-57.7|-31.6|||Cochran-Mantel-Haenszel|||Iron isomaltoside/ferric derisomaltose was compared to ferric carboxymaltose by estimation of the risk difference and the associated 95 % CI, adjusting for strata (type of underlying disease (women with IDA due to gynaecological blood losses; yes/no) and screening s-phosphate level (\< or ≥ 3.5 mg/dL)) using the Cochran-Mantel-Haenszel method.||-31.6|-57.7|<0.0001
70973519|NCT03237065|141453835|SUPERIORITY||Mean Difference (Final Values)|0.46|||<|0.0001|TWO_SIDED|95.0|0.3|0.62|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.62|0.30|<0.0001
70973520|NCT03237065|141453835|SUPERIORITY||Mean Difference (Final Values)|0.54|||<|0.0001|TWO_SIDED|95.0|0.32|0.76|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.76|0.32|<0.0001
71032506|NCT00486863|141573938|SUPERIORITY_OR_OTHER|||||||0.988||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.988
71032507|NCT00486863|141573939|SUPERIORITY_OR_OTHER||||||>|0.999||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Chi-squared|||||||>0.999
71032508|NCT00486863|141573940|SUPERIORITY_OR_OTHER|||||||0.926||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.926
71032509|NCT00486863|141573941|SUPERIORITY_OR_OTHER|||||||0.502||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||||||0.502
71032510|NCT00486863|141573942|SUPERIORITY_OR_OTHER|||||||0.439||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||||||0.439
71032511|NCT00486863|141573943|SUPERIORITY_OR_OTHER|||||||0.704||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.704
71094733|NCT03720847|141697451|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.03|TWO_SIDED||||||t-test, 2 sided|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.|Positive estimated value indicates a greater perimenstrual increase in the outcome in the placebo condition relative to the active condition.|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.||||.030
71094734|NCT03720847|141697452|SUPERIORITY||Mean Difference (Final Values)|3.16||||0.013|TWO_SIDED||||||t-test, 2 sided||Positive estimated value indicates greater perimenstrual increase in symptoms in the placebo condition relative to the active condition.|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.||||.013
71094735|NCT03720847|141697453|SUPERIORITY||Mean Difference (Final Values)|3.65||||0.018|TWO_SIDED||||||t-test, 2 sided||Positive estimated value indicates greater perimenstrual change in the placebo condition relative to the active condition.|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.||||.018
71032512|NCT00486863|141573944|SUPERIORITY_OR_OTHER|||||||0.517||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.517
71032513|NCT00486863|141573945|SUPERIORITY_OR_OTHER|||||||0.524||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||Analysis included the transferrin receptor: ferritin ratio from the cord blood.||||0.524
71032514|NCT00486863|141573945|SUPERIORITY_OR_OTHER|||||||0.07||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||Analysis included the transferrin receptor: ferritin ratio from the heel stick.||||0.070
71032515|NCT00486863|141573946|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Chi-squared|||||||<0.001
71032516|NCT00486863|141573951|SUPERIORITY_OR_OTHER|||||||0.991||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Chi-squared|||||||0.991
71032517|NCT00355797|141573958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.17|STANDARD_DEVIATION|15.9||0.004|TWO_SIDED|95.0|3.24|15.11|||t-test, 2 sided|||The endpoint will compare the composite percent change in ADL performance for patients while their devices are programmed to CLS and accelerometer pacing modes, using the no rate adaptive pacing mode as the baseline. Null hypothesis: mean composite of percent change for patients with their device programmed to CLS is less than or equal to the mean composite of percent change for the same patients with their device in accelerometer.||15.11|3.24|0.004
71094736|NCT03720847|141697454|SUPERIORITY||Mean Difference (Final Values)|1.04||||0.073|TWO_SIDED||||||t-test, 2 sided||Positive estimated value indicates greater perimenstrual increase in symptoms in the placebo condition relative to the active condition.|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.||||.073
71094737|NCT03720847|141697455|SUPERIORITY||Mean Difference (Final Values)|-1.16||||0.25|TWO_SIDED||||||t-test, 2 sided|||paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.||||.25
71094738|NCT03720847|141697456|SUPERIORITY||Mean Difference (Final Values)|-1.32||||0.23|TWO_SIDED||||||t-test, 2 sided|||paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.||||.23
71094739|NCT02734667|141697477|SUPERIORITY||t statistic from GLM/regression|-0.47||||0.64|TWO_SIDED|||||Generalized linear models were used to compare outcomes between the CGM and control groups at 6 months while adjusting for participant gender, age, annual household income, days since diagnosis, and baseline A1c.|Regression, Linear|||||||0.64
70973521|NCT03237065|141453835|SUPERIORITY||Mean Difference (Final Values)|0.73|||<|0.0001|TWO_SIDED|95.0|0.49|0.96|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.96|0.49|<0.0001
70973522|NCT03237065|141453835|SUPERIORITY||Mean Difference (Final Values)|1.22|||<|0.0001|TWO_SIDED|95.0|0.99|1.46|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.46|0.99|<0.0001
70973523|NCT03237065|141453835|SUPERIORITY||Mean Difference (Final Values)|1.24|||<|0.0001|TWO_SIDED|95.0|0.98|1.51|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.51|0.98|<0.0001
70973524|NCT03237065|141453835|SUPERIORITY||Mean Difference (Final Values)|1.17|||<|0.0001|TWO_SIDED|95.0|0.91|1.43|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.43|0.91|<0.0001
70973525|NCT03237065|141453836|SUPERIORITY||Mean Difference (Final Values)|13.99|||<|0.0001|TWO_SIDED|95.0|9.38|18.59|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||18.59|9.38|<0.0001
70973526|NCT03237065|141453836|SUPERIORITY||Mean Difference (Final Values)|15.84|||<|0.0001|TWO_SIDED|95.0|9.45|22.23|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||22.23|9.45|<0.0001
71032518|NCT00355797|141573965|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.42|STANDARD_DEVIATION|17.74||0.552|TWO_SIDED|95.0|-6.17|3.33|||t-test, 2 sided|||The purpose of endpoint was to evaluate the percent change in pulse pressure during test. The null hypothesis was the mean percent change for patients with their device programmed to CLS is greater or equal to the mean percent change for the same patients with their device in accelerometer.||3.33|-6.17|0.552
71032519|NCT00355797|141573965|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.91|STANDARD_DEVIATION|21.34||0.505|TWO_SIDED|95.0|-3.8|7.63|||t-test, 2 sided|||The purpose of endpoint was to evaluate the percent change in pulse pressure during test. The null hypothesis was the mean percent change for patients with their device programmed to CLS is greater or equal to the mean percent change for the same patients with their device without rate adaptative pacing.||7.63|-3.80|0.505
71094740|NCT02734667|141697478|SUPERIORITY||t-statistic from GLM/regression results|-2.6||||0.013|TWO_SIDED|||||Generalized linear models were used to compare outcomes between the CGM and control groups at 6 months while adjusting for participant gender, age, annual household income, days since diagnosis, and baseline A1c.|Regression, Linear|||||||0.013
71032520|NCT02028715|141574024|SUPERIORITY||Mean Difference (Final Values)|5.55501|STANDARD_ERROR_OF_MEAN|5.96535||0.356|TWO_SIDED|95.0|-6.3904|17.50042|||t-test for Equality of Means|||||17.50042|-6.39040|.356
71032521|NCT02028715|141574025|SUPERIORITY||Median Difference (Final Values)|11.51818|STANDARD_ERROR_OF_MEAN|6.98569||0.105|TWO_SIDED|95.0|-2.49963|25.53599|||t-test for Equality of Means|||||25.53599|-2.49963|.105
71032522|NCT02028715|141574026|SUPERIORITY|||||||0.029|||||||ANOVA|||||||.029
71032523|NCT02028715|141574027|SUPERIORITY|Within subjects Analysis of Variance (ANOVA) of time, sphericity assumed, was used for pain, nausea, bloating and pruritus.||||||0.643|||||||ANOVA|||||||.643
71032524|NCT02028715|141574028|SUPERIORITY|Within subjects Analysis of Variance (ANOVA) of time, sphericity assumed, was used for pain, nausea, bloating and pruritus.||||||0.217|||||||ANOVA|||||||.217
71032525|NCT02028715|141574029|SUPERIORITY|Within subjects Analysis of Variance (ANOVA) of time, sphericity assumed, was used for pain, nausea, bloating and pruritus.||||||0.647|||||||ANOVA|||||||.647
71094741|NCT02734667|141697479|SUPERIORITY||t-statistic from GLM/regression results|3.12||||0.003|TWO_SIDED|||||Generalized linear models were used to compare outcomes between the CGM and control groups at 6 months while adjusting for participant gender, age, annual household income, days since diagnosis, and baseline A1c.|Regression, Linear|||||||0.003
70973527|NCT03237065|141453836|SUPERIORITY||Mean Difference (Final Values)|21.66|||<|0.0001|TWO_SIDED|95.0|14.72|28.59|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||28.59|14.72|<0.0001
70973528|NCT03237065|141453836|SUPERIORITY||Mean Difference (Final Values)|36.17|||<|0.0001|TWO_SIDED|95.0|29.28|43.06|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||43.06|29.28|<0.0001
70973529|NCT03237065|141453836|SUPERIORITY||Mean Difference (Final Values)|37.86|||<|0.0001|TWO_SIDED|95.0|29.99|45.72|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||45.72|29.99|<0.0001
70973530|NCT03237065|141453836|SUPERIORITY||Mean Difference (Final Values)|34.53|||<|0.0001|TWO_SIDED|95.0|26.8|42.26|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||42.26|26.80|<0.0001
70973531|NCT03237065|141453838|SUPERIORITY||Mean Difference (Final Values)|-96.8|||<|0.0001|TWO_SIDED|95.0|-119.8|-73.8|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-73.8|-119.8|<0.0001
70973532|NCT03237065|141453838|SUPERIORITY||Mean Difference (Final Values)|-15.7||||0.1064|TWO_SIDED|95.0|-34.9|3.4|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||3.4|-34.9|0.1064
70973533|NCT03237065|141453838|SUPERIORITY||Mean Difference (Final Values)|-251.7|||<|0.0001|TWO_SIDED|95.0|-307.2|-196.2|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-196.2|-307.2|<0.0001
70973534|NCT03237065|141453838|SUPERIORITY||Mean Difference (Final Values)|-79.1|||<|0.0001|TWO_SIDED|95.0|-103.7|-54.5|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-54.5|-103.7|<0.0001
70973535|NCT03237065|141453838|SUPERIORITY||Mean Difference (Final Values)|-61.8|||<|0.0001|TWO_SIDED|95.0|-83.0|-40.5|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-40.5|-83.0|<0.0001
70973536|NCT03237065|141453838|SUPERIORITY||Mean Difference (Final Values)|-18.0||||0.0039|TWO_SIDED|95.0|-30.1|-5.9|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-5.9|-30.1|0.0039
71032526|NCT02028715|141574030|SUPERIORITY||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-0.587|0.695||||||||.695|-.587|
71032527|NCT01149473|141574048|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|109.0|||||TWO_SIDED|90.0|98.1|120.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||120|98.1|
71094742|NCT05177094|141697494|SUPERIORITY||Posterior Mean Difference|-0.15|||||TWO_SIDED|95.0|-0.7|0.4|||||Posterior mean difference with 95% credible interval is reported.|||0.40|-0.70|
71094743|NCT05177094|141697495|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.66|0.64|||||Posterior mean difference with 95% credible interval is reported.|||0.64|-0.66|
71094744|NCT05177094|141697496|SUPERIORITY||Posterior Mean Difference|-0.13|||||TWO_SIDED|95.0|-0.72|0.46|||||Posterior mean difference with 95% credible interval is reported.|||0.46|-0.72|
70973537|NCT03237065|141453839|SUPERIORITY||Mean Difference (Final Values)|-57.5||||0.1243|TWO_SIDED|95.0|-131.1|16.1|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||16.1|-131.1|0.1243
70973538|NCT03237065|141453839|SUPERIORITY||Mean Difference (Final Values)|20.7||||0.5547|TWO_SIDED|95.0|-49.7|91.0|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||91.0|-49.7|0.5547
70973539|NCT03237065|141453839|SUPERIORITY||Mean Difference (Final Values)|-155.7||||0.0005|TWO_SIDED|95.0|-234.7|-76.6|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-76.6|-234.7|0.0005
71032528|NCT01149473|141574049|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.0|||||TWO_SIDED|90.0|98.8|106.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||106|98.8|
71094745|NCT05177094|141697497|SUPERIORITY||Posterior Mean Difference|-0.26|||||TWO_SIDED|95.0|-0.98|0.46|||||Posterior mean difference with 95% credible interval is reported.|||0.46|-0.98|
71094746|NCT05177094|141697498|SUPERIORITY||Posterior Mean Difference|-0.22|||||TWO_SIDED|95.0|-0.61|0.18|||||Posterior mean difference with 95% credible interval is reported.|||0.18|-0.61|
71094747|NCT05177094|141697499|SUPERIORITY||Posterior Mean Difference|-0.17|||||TWO_SIDED|95.0|-0.58|0.24|||||Posterior mean difference with 95% credible interval is reported.|||0.24|-0.58|
71094748|NCT05177094|141697500|SUPERIORITY||Posterior Mean Difference|-0.12|||||TWO_SIDED|95.0|-0.68|0.45|||||Posterior mean difference with 95% credible interval is reported.|||0.45|-0.68|
70973540|NCT03237065|141453839|SUPERIORITY||Mean Difference (Final Values)|-27.3||||0.3516|TWO_SIDED|95.0|-86.0|31.5|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||31.5|-86.0|0.3516
71094749|NCT05177094|141697501|SUPERIORITY||Posterior Mean Difference|0.06|||||TWO_SIDED|95.0|-0.65|0.77|||||Posterior mean difference with 95% credible interval is reported.|||0.77|-0.65|
71094750|NCT05177094|141697502|SUPERIORITY||Posterior Mean Difference|-3.09|||||TWO_SIDED|95.0|-10.43|4.28|||||Posterior mean difference with 95% credible interval is reported.|||4.28|-10.43|
71094751|NCT05177094|141697503|SUPERIORITY||Posterior Mean Difference|-1.5|||||TWO_SIDED|95.0|-10.04|7.0|||||Posterior mean difference with 95% credible interval is reported.|||7.00|-10.04|
71094752|NCT05177094|141697504|SUPERIORITY||Posterior Mean Difference|0.12|||||TWO_SIDED|95.0|-0.32|0.54|||||Posterior mean difference with 95% credible interval is reported.|||0.54|-0.32|
71094753|NCT05177094|141697505|SUPERIORITY||Posterior Mean Difference|0.2|||||TWO_SIDED|95.0|-0.24|0.65|||||Posterior mean difference with 95% credible interval is reported.|||0.65|-0.24|
71094754|NCT05177094|141697506|SUPERIORITY||Posterior Mean Difference|44.36|||||TWO_SIDED|95.0|-114.73|204.0|||||Posterior mean difference with 95% credible interval is reported.|||204.00|-114.73|
71094755|NCT05177094|141697507|SUPERIORITY||Posterior Mean Difference|-98.76|||||TWO_SIDED|95.0|-231.86|34.49|||||Posterior mean difference with 95% credible interval is reported.|||34.49|-231.86|
71094756|NCT05177094|141697508|SUPERIORITY||Posterior Mean Difference|0.01|||||TWO_SIDED|95.0|-0.05|0.07|||||Posterior mean difference with 95% credible interval is reported.|||0.07|-0.05|
71094757|NCT05177094|141697509|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.09|0.08|||||Posterior mean difference with 95% credible interval is reported.|||0.08|-0.09|
71094758|NCT00924482|141697514|SUPERIORITY_OR_OTHER_LEGACY||Correlation Coefficient (R^2)|0.63||||||95.0|||||Regression, Linear|Linear regression between the average of six thermodilution cardiac output measurements was compared to the average of six ECOM output measurements||||||
71094759|NCT00875667|141697526|SUPERIORITY||Stratified Hazard Ratio|0.63||||0.012|TWO_SIDED|95.0|0.43|0.9||Stratification factors were: time from diagnosis to first dose, time from last prior anti-lymphoma therapy to first dose, prior stem cell transplant, and MIPI at baseline|Stratified Log Rank Test|||||0.90|0.43|0.012
71094760|NCT00875667|141697527|SUPERIORITY||Stratified Hazard Ratio|0.6||||0.003|TWO_SIDED|95.0|0.43|0.85||Stratification factors were: time from diagnosis to first dose, time from last prior anti-lymphoma therapy to first dose, prior stem cell transplant, and MIPI at baseline|Stratified Log Rank Test||The weights are based on observed events at the time the third DMC meeting was held and based on the difference between observed and expected events at the time of the primary analysis.|||0.85|0.43|0.003
70973541|NCT03237065|141453839|SUPERIORITY||Mean Difference (Final Values)|-24.3||||0.1988|TWO_SIDED|95.0|-62.3|13.7|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||13.7|-62.3|0.1988
70973542|NCT03237065|141453839|SUPERIORITY||Mean Difference (Final Values)|11.3||||0.4379|TWO_SIDED|95.0|-18.6|41.2|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||41.2|-18.6|0.4379
71094761|NCT00875667|141697528|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71094762|NCT00875667|141697529|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71094763|NCT00875667|141697530|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.421|TWO_SIDED|95.0|0.29|1.68|||Log Rank|||||1.68|0.29|0.421
71094764|NCT00875667|141697531|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.875|TWO_SIDED|95.0|0.52|1.74|||Log Rank|||||1.74|0.52|0.875
71094765|NCT00875667|141697532|SUPERIORITY|||||||0.313|||||||Chi-squared|||||||0.313
71094766|NCT00875667|141697533|SUPERIORITY|||||||0.465|||||||Chi-squared|||||||0.465
71094767|NCT00875667|141697534|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.005|TWO_SIDED|95.0|0.45|0.87|||Log Rank|||||0.87|0.45|0.005
71094768|NCT00875667|141697535|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.003|TWO_SIDED|95.0|0.46|0.86|||Log Rank|||||0.86|0.46|0.003
71094769|NCT00875667|141697536|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.046|TWO_SIDED|95.0|0.54|1.0|||Log Rank|||||1.00|0.54|0.046
71094770|NCT00875667|141697537|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.095|TWO_SIDED|95.0|0.58|1.05|||Log Rank|||||1.05|0.58|0.095
71094771|NCT00875667|141697538|SUPERIORITY||Hazard Ratio (HR)|3.91|||<|0.001|TWO_SIDED|95.0|1.95|7.85|||Log Rank|||||7.85|1.95|<0.001
71094772|NCT00875667|141697539|SUPERIORITY||Hazard Ratio (HR)|2.06|||<|0.004|TWO_SIDED|95.0|1.24|3.42|||Log Rank|||||3.42|1.24|<0.004
71094773|NCT00875667|141697540|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.519|TWO_SIDED|95.0|0.62|1.28|||Log Rank|||||1.28|0.62|0.519
71094774|NCT00875667|141697541|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.558|TWO_SIDED|95.0|0.67|1.25|||Log Rank|||||1.25|0.67|0.558
71094775|NCT00412451|141697576|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.001||||0.131|TWO_SIDED|95.0|0.001|999.999|||Fisher Exact|||||999.999|0.001|0.131
71094776|NCT00412451|141697576|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.562||||0.67|TWO_SIDED|95.0|0.132|2.4|||Fisher Exact|||||2.400|0.132|0.670
71094777|NCT00412451|141697576|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.346||||0.372||95.0|0.07|1.703|||Fisher Exact|||||1.703|0.070|0.372
71094778|NCT00195429|141697589|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Fisher Exact|||||||1.0
71094779|NCT00195429|141697590|SUPERIORITY_OR_OTHER_LEGACY|||||||0.361||95.0|||||Student's t-test|||||||0.361
71094780|NCT04925934|141697633|SUPERIORITY||Rate Difference|2.8|||=|0.7474|TWO_SIDED|90.0|-11.4|17.0|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.||17.0|-11.4|=0.7474
71094781|NCT04925934|141697633|SUPERIORITY||Rate Difference|-0.1|||=|0.9942|TWO_SIDED|90.0|-14.2|14.1|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.||14.1|-14.2|=0.9942
71094782|NCT04925934|141697634|SUPERIORITY||Rate Difference|37.2|||=|0.1626|TWO_SIDED|90.0|-0.3|74.7|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment, randomization stratification factors and Baseline CLASI-A score in the model.||74.7|-0.3|=0.1626
71094783|NCT04925934|141697634|SUPERIORITY||Rate Difference|24.1|||=|0.2873|TWO_SIDED|90.0|-7.5|55.8|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment, randomization stratification factors and Baseline CLASI-A score in the model.||55.8|-7.5|=0.2873
71094784|NCT04925934|141697635|SUPERIORITY||Rate Difference|8.6|||=|0.322|TWO_SIDED|90.0|-5.6|22.7|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.||22.7|-5.6|=0.3220
71094785|NCT04925934|141697635|SUPERIORITY||Rate Difference|2.9|||=|0.7364|TWO_SIDED|90.0|-11.2|17.0|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.||17.0|-11.2|=0.7364
71094786|NCT04925934|141697636|SUPERIORITY||Rate Difference|11.7|||=|0.2805|TWO_SIDED|90.0|-6.1|29.4|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment, stratification factors (SLEDAI-2K only) and Baseline OGC dose included in the model.||29.4|-6.1|=0.2805
71094787|NCT04925934|141697636|SUPERIORITY||Rate Difference|9.4|||=|0.3926|TWO_SIDED|90.0|-8.6|27.3|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment, stratification factors (SLEDAI-2K only) and Baseline OGC dose included in the model.||27.3|-8.6|=0.3926
71094788|NCT04925934|141697637|SUPERIORITY||Rate Difference|16.5|||=|0.037|TWO_SIDED|90.0|4.0|29.0|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.||29.0|4.0|=0.0370
71094789|NCT04925934|141697637|SUPERIORITY||Rate Difference|4.9|||=|0.4939|TWO_SIDED|90.0|-6.7|16.4|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.||16.4|-6.7|=0.4939
71094790|NCT03158688|141697643|SUPERIORITY||Stratified Cox model hazard ratio|0.63||||0.0014|TWO_SIDED|95.0|0.464|0.854||alpha level of 0.025|Log Rank||KdD/Kd|Stratification factors used in the Log-rank p-value (1-sided) and the Cox model hazard ratio (KdD/Kd) were as assessed at randomization: International Staging System stage at screening (Stage 1 or 2 vs Stage 3); prior proteasome inhibitor exposure (yes vs no); number of prior lines of therapy (1 vs \>= 2).||0.854|0.464|0.0014
71094791|NCT03158688|141697644|SUPERIORITY||Odds Ratio (OR)|1.925||||0.004|TWO_SIDED|95.0|1.184|3.129|||Cochran-Mantel-Haenszel||KdD/Kd|"Odds ratios and corresponding 95% CIs were estimated using the stratified Mantel-Haenszel method.~P-values were calculated using the stratified Cochran-Mantel-Haenszel Chi-Square test."||3.129|1.184|0.0040
71094792|NCT03158688|141697645|SUPERIORITY||Odds Ratio (OR)|7.819|||||TWO_SIDED|95.0|2.364|25.858|||||KdD/Kd|Odds ratios and corresponding 95% CIs were estimated using the stratified Mantel-Haenszel method.||25.858|2.364|
71094793|NCT03158688|141697646|SUPERIORITY||Cox Proportional Hazard|0.784||||0.0417|TWO_SIDED|95.0|0.595|1.033|||Log Rank||KdD/Kd|"Hazard ratio and corresponding 95% CIs were estimated using the stratified Cox proportional hazards models.~1-sided p-value from the log-rank test controlling for the randomization stratification factors."||1.033|0.595|0.0417
71094794|NCT03158688|141697655|SUPERIORITY||Odds Ratio (OR)|4.403|||||TWO_SIDED|95.0|2.007|9.656|||||KdD/Kd|Odds ratios and corresponding 95% CIs were estimated by a stratified analysis using the Mantel-Haenszel method.||9.656|2.007|
70920619|NCT00520546|141331975|SUPERIORITY_OR_OTHER||specificity|100.0||||0.0043|TWO_SIDED|95.0|3.0|100.0|||Fisher Exact|||"results from PET/MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||100|3|0.0043
70920620|NCT00520546|141331975|SUPERIORITY_OR_OTHER||accuracy|95.0||||0.0043|TWO_SIDED|95.0|82.0|99.0|||Fisher Exact|||"results from PET/MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||99|82|0.0043
70920621|NCT00520546|141331976|SUPERIORITY_OR_OTHER||positive prediction|69.0||||0.09||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.09
70920622|NCT00520546|141331976|SUPERIORITY_OR_OTHER||negative prediction|44.0||||0.09||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.09
70920623|NCT00520546|141331976|SUPERIORITY_OR_OTHER||sensitivity|71.0||||0.09||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.09
70920624|NCT00520546|141331976|SUPERIORITY_OR_OTHER||specificity|42.0||||0.09||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.09
70920625|NCT00520546|141331976|SUPERIORITY_OR_OTHER||accuracy|61.0||||0.09||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.09
70920626|NCT00520546|141331976|SUPERIORITY_OR_OTHER||positive prediction|60.0||||0.27||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.27
71094795|NCT03158688|141697656|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|1.24||0.948|TWO_SIDED|95.0|-2.52|2.35|||linear mixed effects model||The overall treatment difference (KdD - Kd)|Analysis was performed based on a linear mixed effects model. The model included fixed effects of treatment (all baseline responses were modeled with a dummy treatment), baseline QLQ-C30 GHS/QoL score, randomization stratification factors (ISS stage at screening (Stage 1 or 2 vs Stage 3), prior proteasome inhibitor exposure (yes vs no), number of prior lines of therapy (1 vs ≥ 2)), interaction between treatment and time, and random effects of participant intercept and random slope of time.||2.35|-2.52|0.9480
71094796|NCT04837521|141697671|SUPERIORITY||γ01|0.25||||0.03|TWO_SIDED||||||t-test, 2 sided||analysis completed using the 1 week follow up data|||||.03
71094797|NCT04837521|141697672|OTHER|The conditions were expected to be similar, and the primary interest of the analysis was changes over time across both groups.|Mean Difference (Final Values)|3.4|||||TWO_SIDED|95.0|2.32|4.49||To estimate the mean improvement in PSFS across the entire sample, we calculated a posterior predictive distribution of within-person change scores between time fixed equal to 0 and equal to -1.|Bayesian framework|||PSFS scores were analyzed using mixed-effects linear growth models with time, treatment condition, and their interaction as predictors. Random effects modeled variation in intercepts, slopes over time, and their covariance. Time was specified as a continuous variable, centered on the final observation date. The SG group served as the reference level for the treatment factor. Models were estimated in a Bayesian framework using default priors in the brms package.||4.49|2.32|
71094798|NCT01944774|141697690|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 500mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.291||||0.133|TWO_SIDED|95.0|0.058|1.457||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||1.457|0.058|0.133
71094799|NCT01944774|141697690|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 650mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.492||||0.423|TWO_SIDED|95.0|0.087|2.788||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||2.788|0.087|0.423
70973543|NCT03237065|141453840|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.6869|TWO_SIDED|95.0|-1.06|0.7|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.70|-1.06|0.6869
70973544|NCT03237065|141453840|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.1037|TWO_SIDED|95.0|-2.29|0.22|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.22|-2.29|0.1037
70973545|NCT03237065|141453840|SUPERIORITY||Mean Difference (Final Values)|-1.62||||0.0213|TWO_SIDED|95.0|-2.99|-0.25|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.25|-2.99|0.0213
70973546|NCT03237065|141453840|SUPERIORITY||Mean Difference (Final Values)|-1.91||||0.0176|TWO_SIDED|95.0|-3.47|-0.34|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.34|-3.47|0.0176
70973547|NCT03237065|141453840|SUPERIORITY||Mean Difference (Final Values)|-1.37||||0.0999|TWO_SIDED|95.0|-3.01|0.27|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.27|-3.01|0.0999
70973548|NCT03237065|141453840|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.8878|TWO_SIDED|95.0|-1.77|2.04|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||2.04|-1.77|0.8878
70973549|NCT03237065|141453841|SUPERIORITY||Mean Difference (Final Values)|21.81|||<|0.0001|TWO_SIDED|95.0|17.66|25.95|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||25.95|17.66|<0.0001
70973550|NCT03237065|141453841|SUPERIORITY||Mean Difference (Final Values)|4.64||||0.2923|TWO_SIDED|95.0|-4.05|13.33|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||13.33|-4.05|0.2923
70973551|NCT03237065|141453841|SUPERIORITY||Mean Difference (Final Values)|19.56|||<|0.0001|TWO_SIDED|95.0|12.37|26.74|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||26.74|12.37|<0.0001
70973552|NCT03237065|141453841|SUPERIORITY||Mean Difference (Final Values)|33.05|||<|0.0001|TWO_SIDED|95.0|25.96|40.14|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||40.14|25.96|<0.0001
71032529|NCT01149473|141574050|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|101.0|||||TWO_SIDED|90.0|98.6|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104|98.6|
71094800|NCT01944774|141697691|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 500mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.276||||0.118|TWO_SIDED|95.0|0.055|1.385||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||1.385|0.055|0.118
70973553|NCT03237065|141453841|SUPERIORITY||Mean Difference (Final Values)|21.82|||<|0.0001|TWO_SIDED|95.0|14.2|29.43|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||29.43|14.20|<0.0001
70973554|NCT03237065|141453841|SUPERIORITY||Mean Difference (Final Values)|9.03||||0.025|TWO_SIDED|95.0|1.16|16.9|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||16.90|1.16|0.0250
70973555|NCT03237065|141453842|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.5134|TWO_SIDED|95.0|-0.22|0.11|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.11|-0.22|0.5134
70973556|NCT03237065|141453842|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.7579|TWO_SIDED|95.0|-0.24|0.32|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.32|-0.24|0.7579
70973557|NCT03237065|141453842|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.3169|TWO_SIDED|95.0|-0.41|0.14|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.14|-0.41|0.3169
70973558|NCT03237065|141453842|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.0018|TWO_SIDED|95.0|-0.76|-0.18|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.18|-0.76|0.0018
70973559|NCT03237065|141453842|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.0003|TWO_SIDED|95.0|-0.77|-0.24|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.24|-0.77|0.0003
70973560|NCT03237065|141453842|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.1063|TWO_SIDED|95.0|-0.5|0.05|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.05|-0.50|0.1063
70973561|NCT03237065|141453843|SUPERIORITY||Mean Difference (Final Values)|4.57||||0.2166|TWO_SIDED|95.0|-2.72|11.85|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||11.85|-2.72|0.2166
71094801|NCT01944774|141697691|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 650mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.644||||0.636|TWO_SIDED|95.0|0.104|3.999||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||3.999|0.104|0.636
71094802|NCT01944774|141697692|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 500mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.517||||0.456|TWO_SIDED|95.0|0.091|2.93||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||2.930|0.091|0.456
71094803|NCT01944774|141697692|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 650mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.508||||0.445|TWO_SIDED|95.0|0.09|2.883||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||2.883|0.090|0.445
71094804|NCT01944774|141697693|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 500mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.518||||0.458|TWO_SIDED|95.0|0.091|2.941||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||2.941|0.091|0.458
71154081|NCT04941482|141800636|SUPERIORITY||Mean Difference (Net)|-7.8|STANDARD_ERROR_OF_MEAN|-3.7|<|0.05|TWO_SIDED|95.0|-15.2|-0.3||The threshold for statistical significance was p = 0.05.|t-test, 2 sided||Treatment Difference = Intervention group - Control group|We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.|(1) Variables with multiple measurements over time were compared using the repeated measures ANOVA test to assess changes in Stroke Impact Scale score before and after intervention in two groups, calculating the time\*group interaction; (2) Effect sizes after intervention are measured using Cohen's D, with values indicating small (d = 0.2), medium (d = 0.5), and large (d ≥ 0.8) effects.|-0.3|-15.2|<0.05
70920627|NCT00520546|141331976|SUPERIORITY_OR_OTHER||negative prediction|30.0||||0.27||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.27
71154082|NCT05615935|141800649|SUPERIORITY||Adjusted Mean Difference (ANCOVA)|2.07|||<|0.001|TWO_SIDED|||||The p-value is adjusted for multiple comparisons using the Bonferroni correction, with a significance threshold of 0.05.|ANCOVA|||Using G\*Power 3.1, the required sample size for ANCOVA with two groups was estimated with a significance level of 0.05, statistical power of 0.80, and an effect size of 0.35, based on Cohen's guidelines for a medium-to-large effect commonly applied in behavioral research (Cohen, 1988). Assuming up to two covariates, a minimum of 67 participants was required. Accounting for a 10% attrition rate, the final target was set at 74 participants.||||<0.001
71154083|NCT05615935|141800650|SUPERIORITY||Adjusted Mean Difference (ANCOVA)|4.58||||0.15|TWO_SIDED|||||The p-value is adjusted for multiple comparisons using the Bonferroni correction, with a significance threshold of 0.05.|ANCOVA|||||||0.15
71154084|NCT05615935|141800650|SUPERIORITY||Median Difference (Final Values)|-2.64|STANDARD_DEVIATION|6.35||0.02|TWO_SIDED|||||The p-value is adjusted for multiple comparisons using the Bonferroni correction, with a significance threshold of 0.05.|t-test, 2 sided|||||||0.02
70920628|NCT00520546|141331976|SUPERIORITY_OR_OTHER||sensitivity|48.0||||0.27||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.27
70920629|NCT00520546|141331976|SUPERIORITY_OR_OTHER||specificity|40.0||||0.27||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.27
70920630|NCT00520546|141331976|SUPERIORITY_OR_OTHER||accuracy|45.0||||0.27||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.27
71154085|NCT04879628|141800674|SUPERIORITY||Rate ratio|0.21|||||TWO_SIDED|95.0|0.08|0.56||||||Negative binomial regression model adjusting for the categorical baseline GdE T1 lesion count (presence/absence) as covariate, treatment as factor, with offset equal to the log of the duration (in months) between the Week 12 MRI and previous MRI at Week 8.||0.56|0.08|
71154086|NCT04879628|141800674|SUPERIORITY||Rate ratio|0.11|||||TWO_SIDED|95.0|0.03|0.38||||||Negative binomial regression model adjusting for the categorical baseline GdE T1 lesion count (presence/absence) as covariate, treatment as factor, with offset equal to the log of the duration (in months) between the Week 12 MRI and previous MRI at Week 8.||0.38|0.03|
70920631|NCT00520546|141331976|SUPERIORITY_OR_OTHER||positive prediction|87.0|||<|0.001||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
70920632|NCT00520546|141331976|SUPERIORITY_OR_OTHER||negative prediction|57.0|||<|0.001||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
70920633|NCT00520546|141331976|SUPERIORITY_OR_OTHER||sensitivity|66.0|||<|0.001||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
70920634|NCT00520546|141331976|SUPERIORITY_OR_OTHER||specificity|82.0|||<|0.001||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
70920635|NCT00520546|141331976|SUPERIORITY_OR_OTHER||accuracy|72.0|||<|0.001||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
70920636|NCT00520546|141331977|SUPERIORITY_OR_OTHER||positive prediction|84.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
71094805|NCT01944774|141697693|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 650mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.667||||0.664|TWO_SIDED|95.0|0.107|4.144||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||4.144|0.107|0.664
71094806|NCT01944774|141697694|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.959|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.959
71094807|NCT01944774|141697694|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.961|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.961
71094808|NCT01944774|141697695|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.96|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.960
71094809|NCT01944774|141697695|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.962|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.962
71094810|NCT01944774|141697696|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.95|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.950
71094811|NCT01944774|141697696|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.962|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.962
71094812|NCT01944774|141697697|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.949|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.949
71094813|NCT01944774|141697697|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.962|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.962
71094814|NCT01944774|141697698|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.438||||0.491|TWO_SIDED|95.0|0.042|4.609||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||4.609|0.042|0.491
71094815|NCT01944774|141697698|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.531||||0.619|TWO_SIDED|95.0|0.044|6.444||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||6.444|0.044|0.619
71094816|NCT01944774|141697699|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.444||||0.501|TWO_SIDED|95.0|0.042|4.708||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||4.708|0.042|0.501
71094817|NCT01944774|141697699|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.567||||0.656|TWO_SIDED|95.0|0.047|6.895||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||6.895|0.047|0.656
71154087|NCT05446870|141800683|OTHER||Posterior probability (%)|100.0|||||||||||||||Posterior probability (based on 20000 sets of model parameters) ctDNA fold change (square root scale) coefficient less than zero in the multivariable logistic regression model of pCR, adjusted for baseline ctDNA and treatment assignment.|||
70973562|NCT03237065|141453843|SUPERIORITY||Mean Difference (Final Values)|-4.64||||0.2997|TWO_SIDED|95.0|-13.47|4.19|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||4.19|-13.47|0.2997
71094818|NCT01944774|141697700|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.733||||0.807|TWO_SIDED|95.0|0.061|8.832||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||8.832|0.061|0.807
71094819|NCT01944774|141697700|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.567||||0.656|TWO_SIDED|95.0|0.047|6.895||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||6.895|0.047|0.656
71094820|NCT01944774|141697701|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.7||||0.779|TWO_SIDED|95.0|0.058|8.445||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||8.445|0.058|0.779
71094821|NCT01944774|141697701|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.567||||0.656|TWO_SIDED|95.0|0.047|6.895||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||6.895|0.047|0.656
71094822|NCT03188185|141697702|SUPERIORITY|Hypothesis tests were two-sided with an alpha of 0.05 .|Least Squares Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.99||0.128|TWO_SIDED|95.0|-3.5|0.4||ALK 5461 was compared to placebo using stage-specific MMRM for MADRS-10 Change from Baseline.Model-derived estimates were combined using equal weights|Mixed Models Analysis|||Analysis was conducted for each stage separately, and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 2mg/2mg was compared to placebo (i.e., ALKS 5461 2mg/2mg S1 vs Placebo S1; and ALKS 5461 2mg/2mg S2 vs Placebo S2).||0.4|-3.5|0.128
71094823|NCT02232698|141697750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24|STANDARD_ERROR_OF_MEAN|0.239|<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71094824|NCT02232698|141697751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.059||0.9556|TWO_SIDED||||||ANCOVA|||||||0.9556
71094825|NCT02232698|141697752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.175|<|0.0001|TWO_SIDED|||||Statistical analysis of time spent \<55 mg/dL|ANCOVA|||||||<0.0001
71094826|NCT02232698|141697752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.122||0.0003|TWO_SIDED|||||Statistical analysis of time spent \<40 mg/dL|ANCOVA|||||||0.0003
71094827|NCT02232698|141697753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.089|<|0.0001|TWO_SIDED||||||ANCOVA|||Statistical analysis of frequency of episodes \<70 mg/dL||||<0.0001
71094828|NCT02232698|141697753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.074|<|0.0001|TWO_SIDED||||||ANCOVA|||Statistical analysis of frequency of episodes \<55 mg/dL||||<0.0001
71094829|NCT02232698|141697753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED||||||ANCOVA|||Statistical analysis of frequency of episodes \<40 mg/dL||||<0.0001
71094830|NCT02232698|141697754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.329||0.5623|TWO_SIDED||||||ANCOVA|||Statistical analysis of time spent \>180 mg/dL||||0.5623
70920637|NCT00520546|141331977|SUPERIORITY_OR_OTHER||negative prediction|73.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
70973563|NCT03237065|141453843|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.9221|TWO_SIDED|95.0|-7.75|8.56|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||8.56|-7.75|0.9221
70973564|NCT03237065|141453843|SUPERIORITY||Mean Difference (Final Values)|-15.69||||0.0034|TWO_SIDED|95.0|-26.07|-5.32|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-5.32|-26.07|0.0034
70973565|NCT03237065|141453843|SUPERIORITY||Mean Difference (Final Values)|-22.54||||0.0002|TWO_SIDED|95.0|-33.93|-11.16|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-11.16|-33.93|0.0002
70973566|NCT03237065|141453843|SUPERIORITY||Mean Difference (Final Values)|-24.81|||<|0.0001|TWO_SIDED|95.0|-35.42|-14.21|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-14.21|-35.42|<0.0001
70973567|NCT03237065|141453844|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.3048|TWO_SIDED|95.0|-0.1|0.03|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.03|-0.10|0.3048
70973568|NCT03237065|141453844|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.1641|TWO_SIDED|95.0|-0.02|0.13|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.13|-0.02|0.1641
70973569|NCT03237065|141453844|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.1333|TWO_SIDED|95.0|-0.02|0.12|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.12|-0.02|0.1333
71032530|NCT01149473|141574051|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.0|||||TWO_SIDED|90.0|98.8|108.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108|98.8|
71032531|NCT01149473|141574052|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.7|||||TWO_SIDED|95.0|98.6|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101|98.6|
71094831|NCT02232698|141697754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.163||0.0247|TWO_SIDED||||||ANCOVA|||Statistical analysis for time spent \>240 mg/dL||||0.0247
70920638|NCT00520546|141331977|SUPERIORITY_OR_OTHER||sensitivity|90.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
70920639|NCT00520546|141331977|SUPERIORITY_OR_OTHER||specificity|84.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
70920640|NCT00520546|141331977|SUPERIORITY_OR_OTHER||accuracy|82.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
70973570|NCT03237065|141453844|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.9385|TWO_SIDED|95.0|-0.17|0.16|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.16|-0.17|0.9385
71094832|NCT02232698|141697755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.3||0.0006|TWO_SIDED||||||ANCOVA|||||||0.0006
71094833|NCT02232698|141697758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED||||||ANCOVA|||Statistical analysis of perceived frequency of hyperglycaemia||||<0.0001
71094834|NCT02232698|141697758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0713|TWO_SIDED||||||ANCOVA|||Statistical analysis of perceived frequency of hypoglycaemia||||0.0713
71094835|NCT02232698|141697758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1|STANDARD_ERROR_OF_MEAN|0.84|<|0.0001|TWO_SIDED||||||ANCOVA|||Statistical analysis of total treatment satisfaction score||||<0.0001
71094836|NCT00387127|141697759|SUPERIORITY_OR_OTHER||Difference in percentage of par. with CR|10.7||||0.3658|TWO_SIDED|95.0|-13.4|37.3||From exact test that common odds ratio equals 1|Fisher Exact||Complete response was defined as the percentage of participants achieving a CR as determined by an independent radiological review.|||37.3|-13.4|0.3658
71094837|NCT00387127|141697760|SUPERIORITY_OR_OTHER||Difference in percentage of par. with CR|28.8||||0.013|TWO_SIDED|95.0|5.7|53.6||From exact test that common odds ratio equals 1|Fisher Exact||Complete response was defined as the percentage of participants achieving a CR as determined by the investigator.|||53.6|5.7|0.0130
71094838|NCT00387127|141697769|SUPERIORITY_OR_OTHER||Difference in overall response rate|16.3||||0.1969|TWO_SIDED|95.0|-8.6|42.1||From exact test that common odds ratio equals 1|Fisher Exact||Overall response was defined as the percentage of participants achieving a PR or CR as determined by the investigator.|||42.1|-8.6|0.1969
71094839|NCT03491917|141697793|NON_INFERIORITY|Non-inferiority margin is delta = 0.05.|||||<|0.01||||||The average difference in AUC was 0.023 (two-sided 95% CI: -0.012, 0.059; non-inferiority p \< 0.01 for non-inferiority margin delta = -0.05).|t-test, 2 sided|df: 417.0 for FFDM, 424.6 for DBT plus S-View, and (1, 18.9) for the difference.||The primary endpoint for this study was a non-inferior per-subject average area under the receiver operating characteristic (ROC) curve (AUC) requiring correct lesion localization for DBT (digital breast tomosynthesis) plus S-View (synthesized view) versus FFDM (full field digital mammography). AUCs for each reader were estimated in each review condition based on per-subject probability of malignancy (POM) scores requiring correct lesion localization.||||<0.01
71154088|NCT05446870|141800685|OTHER||Posterior probability (%)|90.99|||||||||||||||Posterior probability (based on 20000 sets of model parameters) ctDNA fold change (square root scale) coefficient less than zero in the multivariable logistic regression model of CRS (CRS3 coded as 1 and CRS1 or 2 coded as 0), adjusted for baseline ctDNA and treatment assignment.|||
71154089|NCT05446870|141800686|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC + MK-4830 arm - % Pembrolizumab + SOC arm) and 95% confidence interval (CI) were based on Miettinen \& Nurminen method.|Difference in Percentage|1.1|||||TWO_SIDED|95.0|-10.0|12.9||||||||12.9|-10.0|
71154090|NCT05446870|141800687|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC + MK-4830 arm - % Pembrolizumab + SOC arm) and 95% CI were based on Miettinen \& Nurminen method.|Difference in Percentage|20.7|||||TWO_SIDED|95.0|3.5|37.0||||||||37.0|3.5|
70973571|NCT03237065|141453844|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.0408|TWO_SIDED|95.0|0.0|0.14|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.14|0.00|0.0408
70973572|NCT03237065|141453844|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.2376|TWO_SIDED|95.0|-0.03|0.12|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.12|-0.03|0.2376
70973573|NCT03237065|141453846|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.0882|TWO_SIDED|95.0|-0.67|0.05|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.05|-0.67|0.0882
70973574|NCT03237065|141453846|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.0941|TWO_SIDED|95.0|-0.74|0.06|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.06|-0.74|0.0941
70973575|NCT03237065|141453846|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.0628|TWO_SIDED|95.0|-0.02|0.66|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.66|-0.02|0.0628
70973576|NCT03237065|141453846|SUPERIORITY||Mean Difference (Final Values)|0.46||||0.0056|TWO_SIDED|95.0|0.14|0.79|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.79|0.14|0.0056
70973577|NCT03237065|141453846|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.0492|TWO_SIDED|95.0|0.0|0.55|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.55|0.00|0.0492
70920641|NCT00520546|141331977|SUPERIORITY_OR_OTHER||positive prediction|71.0||||0.53||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.53
70920642|NCT00520546|141331977|SUPERIORITY_OR_OTHER||negative prediction|33.0||||0.53||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.53
70920643|NCT00520546|141331977|SUPERIORITY_OR_OTHER||sensitivity|73.0||||0.53||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.53
70920644|NCT00520546|141331977|SUPERIORITY_OR_OTHER||specificity|31.0||||0.53||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.53
70920645|NCT00520546|141331977|SUPERIORITY_OR_OTHER||accuracy|60.0||||0.53||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.53
70920646|NCT00520546|141331977|SUPERIORITY_OR_OTHER||positive prediction|96.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
70920647|NCT00520546|141331977|SUPERIORITY_OR_OTHER||negative prediction|73.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
70920648|NCT00520546|141331977|SUPERIORITY_OR_OTHER||sensitivity|87.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
70920649|NCT00520546|141331977|SUPERIORITY_OR_OTHER||specificity|92.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
70920650|NCT00520546|141331977|SUPERIORITY_OR_OTHER||accuracy|88.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
70920651|NCT00520546|141331978|SUPERIORITY_OR_OTHER||positive prediction|67.0||||0.002||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.002
70920652|NCT00520546|141331978|SUPERIORITY_OR_OTHER||negative prediction|69.0||||0.002||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.002
70920653|NCT00520546|141331978|SUPERIORITY_OR_OTHER||sensitivity|86.0||||0.002||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.002
70920654|NCT00520546|141331978|SUPERIORITY_OR_OTHER||specificity|43.0||||0.002||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.002
70920655|NCT00520546|141331978|SUPERIORITY_OR_OTHER||accuracy|67.0||||0.002||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.002
70920656|NCT00520546|141331978|SUPERIORITY_OR_OTHER||positive prediction|59.0||||0.41||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.41
70920657|NCT00520546|141331978|SUPERIORITY_OR_OTHER||negative prediction|46.0||||0.41||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.41
70920658|NCT00520546|141331978|SUPERIORITY_OR_OTHER||sensitivity|66.0||||0.41||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.41
70920659|NCT00520546|141331978|SUPERIORITY_OR_OTHER||specificity|38.0||||0.41||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.41
70920660|NCT00520546|141331978|SUPERIORITY_OR_OTHER||accuracy|54.0||||0.41||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.41
70920661|NCT00520546|141331978|SUPERIORITY_OR_OTHER||positive prediction|86.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
70920662|NCT00520546|141331978|SUPERIORITY_OR_OTHER||negative prediction|76.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
70920663|NCT00520546|141331978|SUPERIORITY_OR_OTHER||sensitivity|83.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
70920664|NCT00520546|141331978|SUPERIORITY_OR_OTHER||specificity|80.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
70973578|NCT03237065|141453846|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.0882|TWO_SIDED|95.0|-0.05|0.64|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.64|-0.05|0.0882
70973579|NCT03237065|141453847|SUPERIORITY||Mean Difference (Final Values)|-6.5||||0.6568|TWO_SIDED|95.0|-35.3|22.3|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||22.3|-35.3|0.6568
70920665|NCT00520546|141331978|SUPERIORITY_OR_OTHER||accuracy|82.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
70920666|NCT04452318|141331997|SUPERIORITY||Odds Ratio (OR)|0.17|||<|0.0001|TWO_SIDED|95.0|0.09|0.332|||Regression, Logistic|||||0.332|0.090|< 0.0001
70920667|NCT04452318|141331998|SUPERIORITY||Odds Ratio (OR)|0.54|||=|0.038|TWO_SIDED|95.0|0.298|0.966|||Regression, Logistic|||||0.966|0.298|= 0.0380
70920668|NCT04452318|141332000|SUPERIORITY||Odds Ratio (OR)|0.13|||<|0.0001|TWO_SIDED|95.0|0.069|0.236|||Regression, Logistic|||||0.236|0.069|< 0.0001
70920669|NCT04452318|141332000|SUPERIORITY||Odds Ratio (OR)|0.41|||=|0.0024|TWO_SIDED|95.0|0.228|0.728|||Regression, Logistic|||||0.728|0.228|= 0.0024
70920670|NCT04452318|141332001|SUPERIORITY||||||<|0.0001|||||||Stratified Wilcoxon Rank Sum Test|||||||< 0.0001
70920671|NCT04452318|141332002|SUPERIORITY||||||<|0.0001|||||||Stratified Wilcoxon Rank Sum Test|||||||< 0.0001
70920672|NCT04452318|141332002|SUPERIORITY||||||=|0.001|||||||Stratified Wilcoxon Rank Sum Test|||||||= 0.0010
70920673|NCT04452318|141332003|SUPERIORITY||||||<|0.0001|||||||Stratified Wilcoxon Rank Sum Test|||||||< 0.0001
70920674|NCT04452318|141332004|SUPERIORITY||Odds Ratio (OR)|0.31|||<|0.0001|TWO_SIDED|95.0|0.208|0.456|||Multiple Imputation, Logistic Regression|||||0.456|0.208|< 0.0001
70920675|NCT04452318|141332006|SUPERIORITY||Odds Ratio (OR)|0.12|||<|0.0001|TWO_SIDED|95.0|0.051|0.286|||Regression, Logistic|||||0.286|0.051|< 0.0001
70920676|NCT04452318|141332007|SUPERIORITY||||||<|0.0001|||||||Stratified Wilcoxon Rank Sum Test|||||||< 0.0001
70920677|NCT04452318|141332008|SUPERIORITY||Odds Ratio (OR)|0.09|||=|0.001|TWO_SIDED|95.0|0.02|0.37|||Regression, Logistic|||||0.370|0.020|= 0.0010
70920678|NCT04452318|141332009|SUPERIORITY||||||<|0.0001|||||||Stratified Wilcoxon Rank Sum Test|||||||< 0.0001
70920679|NCT04452318|141332012|SUPERIORITY||Difference of LS Means|-2.123|STANDARD_ERROR_OF_MEAN|0.295|<|0.0001|TWO_SIDED|95.0|-2.707|-1.539|||ANOVA|||||-1.539|-2.707|< 0.0001
70920680|NCT04452318|141332013|SUPERIORITY||Difference of LS Means|-2.483|STANDARD_ERROR_OF_MEAN|0.342|<|0.0001|TWO_SIDED|95.0|-3.161|-1.806|||ANOVA|||||-1.806|-3.161|< 0.0001
70920681|NCT04452318|141332014|SUPERIORITY||Difference of LS Mean|-2.428|STANDARD_ERROR_OF_MEAN|0.389|<|0.0001|TWO_SIDED|95.0|-3.196|-1.659|||ANOVA|||||-1.659|-3.196|< 0.0001
70973580|NCT03237065|141453847|SUPERIORITY||Mean Difference (Final Values)|-24.2||||0.4929|TWO_SIDED|95.0|-94.0|45.5|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||45.5|-94.0|0.4929
70973581|NCT03237065|141453847|SUPERIORITY||Mean Difference (Final Values)|-91.7||||0.0113|TWO_SIDED|95.0|-162.3|-21.1|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-21.1|-162.3|0.0113
70973582|NCT03237065|141453847|SUPERIORITY||Mean Difference (Final Values)|-240.4|||<|0.0001|TWO_SIDED|95.0|-318.4|-162.3|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-162.3|-318.4|<0.0001
71154091|NCT05446870|141800690|OTHER||Posterior probability (%)|38.75|||||||||||||||Posterior probability (based on 20000 sets of model parameters) coefficient for treatment assignment (MK-4830 containing vs. not) less than zero in Bayesian parametrization of the constrained longitudinal data analysis (cLDA) model, modeling ctDNA value at Cycle 3 and ctDNA value at baseline as bivariate normal.|||
70973583|NCT03237065|141453847|SUPERIORITY||Mean Difference (Final Values)|-135.1|||<|0.0001|TWO_SIDED|95.0|-196.1|-74.0|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-74.0|-196.1|<0.0001
70973584|NCT03237065|141453847|SUPERIORITY||Mean Difference (Final Values)|-67.7||||0.0039|TWO_SIDED|95.0|-113.2|-22.2|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-22.2|-113.2|0.0039
70973585|NCT03237065|141453848|SUPERIORITY||Mean Difference (Final Values)|24.2||||0.0503|TWO_SIDED|95.0|0.0|48.5|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||48.5|-0.0|0.0503
70973586|NCT03237065|141453848|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.5794|TWO_SIDED|95.0|-5.5|9.8|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||9.8|-5.5|0.5794
70973587|NCT03237065|141453848|SUPERIORITY||Mean Difference (Final Values)|-62.2|||<|0.0001|TWO_SIDED|95.0|-70.1|-54.3|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-54.3|-70.1|<0.0001
70973588|NCT03237065|141453848|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.0001|TWO_SIDED|95.0|-10.4|-3.5|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-3.5|-10.4|0.0001
70973589|NCT03237065|141453848|SUPERIORITY||Mean Difference (Final Values)|-5.8||||0.0008|TWO_SIDED|95.0|-9.1|-2.4|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-2.4|-9.1|0.0008
70973590|NCT03237065|141453848|SUPERIORITY||Mean Difference (Final Values)|-4.8||||0.004|TWO_SIDED|95.0|-8.1|-1.6|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-1.6|-8.1|0.0040
71094840|NCT01068912|141697800|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|||||A step-down approach was applied to the primary analysis, with the higher dose of favipiravir first tested against placebo.|Gehan-Wilcoxon|||Time required from first study drug administration to alleviation of the 6 primary influenza symptoms and fever. The primary influenza symptoms included cough, sore throat, headache, nasal congestion, body aches and pains, and fatigue. Symptoms were considered alleviated when all were decreased to ≤1 and decrease persisted unchanged ≥ 21.5 hours. Fever was considered alleviated when maintained at \< 38.0°C (age 20 to \< 65 years) or \< 37.8°C (age ≥ 65 years) ≥ 21.5 hours.||||.05
70920682|NCT04452318|141332015|SUPERIORITY||Difference of LS Mean|-2.441|STANDARD_ERROR_OF_MEAN|0.381|<|0.0001|TWO_SIDED|95.0|-3.194|-1.688|||ANOVA|||||-1.688|-3.194|< 0.0001
70920683|NCT04452318|141332018|OTHER||||||=|0.0621|||||||Fisher Exact|||Testing if there is an association between the observed results and treatment received||||= 0.0621
70920684|NCT04452318|141332019|OTHER||||||=|0.0038|||||||Fisher Exact|||Testing if there is an association between the observed results and treatment received'||||= 0.0038
70920685|NCT04452318|141332022|SUPERIORITY||||||<|0.0001|||||||Stratified Wilcoxon Rank Sum Test|||||||< 0.0001
70920686|NCT04452318|141332030|SUPERIORITY||||||=|0.0273|||||||Stratified Wilcoxon Rank Sum Test|||||||= 0.0273
71032532|NCT01149473|141574053|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.7|||||TWO_SIDED|90.0|98.7|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101|98.7|
71032533|NCT00834067|141574110|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.7||||||90.0|90.1|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104|90.1|
71032534|NCT00834067|141574111|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|104.0||||||90.0|99.9|108.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108|99.9|
71032535|NCT00834067|141574112|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.0||||||90.0|99.7|107.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107|99.7|
71032536|NCT00834067|141574113|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|96.0|106.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106|96|
71032537|NCT00834067|141574114|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|99.1|102.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||102|99.1|
71032538|NCT00834067|141574115|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|99.4|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103|99.4|
71032539|NCT00834067|141574116|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|107.0||||||90.0|99.8|114.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||114|99.8|
71032540|NCT00834067|141574117|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.0||||||90.0|99.0|106.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||106|99|
71032541|NCT00834067|141574118|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.0||||||90.0|98.1|108.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||108|98.1|
71032542|NCT00836056|141574176|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|97.75||||||90.0|91.5|104.42|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.42|91.50|
71032543|NCT00836056|141574177|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|96.77||||||90.0|91.4|102.46|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.46|91.40|
70973591|NCT03237065|141453849|SUPERIORITY||Risk Difference (RD)|-10.7||||0.009|TWO_SIDED|95.0|-18.8|-2.6|||Cochran-Mantel-Haenszel|||The rate difference with 95% Newcombe confidence interval, adjusted for stratum using the Cochran-Mantel-Haenszel method, could not be estimated due to lack of events. Thus, the unadjusted treatment difference is presented together with 95% Wald-based confidence interval. The p-value is based on the Cochran-Mantel-Haenszel statistics.||-2.6|-18.8|0.0090
70973592|NCT04781816|141453951|SUPERIORITY||Least Square Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|7.53|||TWO_SIDED|90.0|-18.26|6.85||||||Analysis was performed using mixed model with repeated measurements (MMRM) including fixed effects for baseline CLASI-A, post-baseline visit, geographical region, disease subtype, baseline use of CQ/HCQ, intervention group, visit-by- intervention group interaction, and visit-by-baseline-CLASI-A interaction.||6.85|-18.26|
70973593|NCT01121393|141453970|SUPERIORITY||||||<|0.0001|TWO_SIDED||||||Log Rank|||A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on PFS compared with gemcitabine / cisplatin chemotherapy.||||<0.0001
70973594|NCT01121393|141453970|SUPERIORITY||Hazard Ratio (HR)|0.281|||||TWO_SIDED|95.0|0.203|0.389||||||A Cox proportional-hazards model, stratified by EGFR mutation category was used to estimate the hazard ratio (HR) and 95% confidence interval (CI) between the 2 treatment arms.||0.389|0.203|
70973595|NCT01121393|141453971|SUPERIORITY||Odds Ratio (OR)|7.572|||<|0.0001|TWO_SIDED|95.0|4.522|12.679|||Regression, Logistic|||A logistic regression model, stratified by EGFR mutation category was used to compare the objective response rate between the 2 treatment arms.||12.679|4.522|<0.0001
70973596|NCT01121393|141453972|SUPERIORITY||Odds Ratio (OR)|3.843|||<|0.0001|TWO_SIDED|95.0|2.039|7.24|||Regression, Logistic|||stratified for EGFR mutation group||7.240|2.039|<0.0001
70973597|NCT01121393|141453973|SUPERIORITY|||||||0.4013|TWO_SIDED||||||Log Rank|||A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on OS compared with gemcitabine / cisplatin chemotherapy.||||0.4013
71094841|NCT04822194|141697801|SUPERIORITY|||||||0.053|||||||Mixed Models Analysis|Ran linear mixed model, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups. Power analyses using an approximate effect size (d=.70) previously reported for within and between-subjects behavioral analyses of longitudinal reappraisal training data indicate over 95% power (α=.05) to detect within-group effects and 90% power (α=.05) to detect between-group effects require 36 per group.||||0.053
71094842|NCT04822194|141697802|SUPERIORITY|||||||0.741|||||||Mixed Models Analysis|Ran linear mixed models on natural log of RMSSD, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups. Power analyses using an approximate effect size (d=.70) previously obtained for within and between-subjects analyses of respiratory sinus arrhythmia data indicate over 95% power (α=.05) to detect within-group effects and 90% power (α=.05) to detect between-group effects should be achieved with 36 per group.||||0.741
71154092|NCT02446600|141800747|SUPERIORITY||Hazard Ratio (HR)|0.856||||0.077|TWO_SIDED|95.0|0.663|1.105||The p-value is one-sided. Per the protocol, the statistical significance threshold was \<0.025. Type 1 error was controlled using hierarchical testing strategy.|Log Rank|The log rank test was stratified by the minimization factors provided at randomization|The hazard ratio estimate compares olaparib+cedirinib to chemotherapy. If olaparib+cedirinib is superior, the hazard ratio is \<1.0.|Arm II was suspended for futility at the interim analysis so was not analyzed at the final analysis.||1.105|0.663|0.077
70973598|NCT01121393|141453973|SUPERIORITY||Hazard Ratio (HR)|0.904|||||TWO_SIDED|95.0|0.715|1.144||||||A Cox proportional hazard model stratified (by EGFR mutation category stratification factor used at randomisation) was used to test the effect of afatinib on OS compared with gemcitabine / cisplatin chemotherapy.||1.144|0.715|
70973599|NCT01121393|141453977|SUPERIORITY||Mean Difference (Final Values)|-13.64|STANDARD_ERROR_OF_MEAN|1.76|<|0.0001|TWO_SIDED|95.0|-17.1|-10.19|||ANCOVA|adjusted for baseline sum of diameters and EGFR mutation group||||-10.19|-17.10|<0.0001
70973600|NCT01121393|141453980|SUPERIORITY|||||||0.0001|TWO_SIDED||||||Log Rank|||A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on HRQOL compared with gemcitabine / cisplatin chemotherapy.||||0.0001
70973601|NCT01121393|141453980|SUPERIORITY||Hazard Ratio (HR)|0.458|||||TWO_SIDED|95.0|0.303|0.692||||||Cox proportional hazard model stratified by EGFR mutation group||0.692|0.303|
70973602|NCT01121393|141453981|SUPERIORITY||||||<|0.0001|TWO_SIDED||||||Log Rank|||A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on HRQOL compared with gemcitabine / cisplatin chemotherapy.||||<0.0001
70973603|NCT01121393|141453981|SUPERIORITY||Hazard Ratio (HR)|0.534|||||TWO_SIDED|95.0|0.394|0.724||||||Cox proportional hazard model stratified by EGFR mutation group||0.724|0.394|
70973604|NCT01121393|141453982|SUPERIORITY|||||||0.022|TWO_SIDED||||||Log Rank|||A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on HRQOL compared with gemcitabine / cisplatin chemotherapy.||||0.0220
70973605|NCT01121393|141453982|SUPERIORITY||Hazard Ratio (HR)|0.699|||||TWO_SIDED|95.0|0.511|0.956||||||Cox proportional hazard model stratified by EGFR mutation group||0.956|0.511|
70973606|NCT01100944|141453997|SUPERIORITY_OR_OTHER|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
70973607|NCT01100944|141454006|SUPERIORITY_OR_OTHER|||||||0.3||||||Fold change at Cycle 2 Day 1 vs. pre was assessed. Only differences with p\<0.005 could be potentially considered statistically significant while those with 0.005\<p\<0.05 would represent trends towards a difference.|Wilcoxon signed rank test|||||||0.30
70973608|NCT01100944|141454006|SUPERIORITY_OR_OTHER|||||||0.0001||||||Fold change at Cycle 1 Day 2 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.0001
70973609|NCT01100944|141454006|SUPERIORITY_OR_OTHER|||||||0.0001||||||Fold change at Cycle 1 Day 3 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.0001
70973610|NCT01100944|141454007|SUPERIORITY_OR_OTHER|||||||0.76||||||Fold change at Cycle 2 Day 1 vs. pre was assessed.Only differences with p\<0.005 could be potentially considered statistically significant while those with 0.005\<p\<0.05 would represent trends towards a difference.|Wilcoxon signed rank test|||||||0.76
71094843|NCT04822194|141697803|SUPERIORITY|||||||0.021|||||||Mixed Models Analysis|Ran linear mixed model, p-value above reflects a group by session interaction.||Null hypothesis: no difference between groups. Power analyses using a within-subject fMRI effect size estimate for right amygdala affective reactivity from a meta-analysis of Human Connectome Project data of approx. d=.70, applying to between-subjects effects as well, indicate over 95% power (α=.05) to detect within-group effects and 90% power (α=0.05) to detect between-group effects should be achieved with 36 participants per group.||||0.021
71094844|NCT04822194|141697804|SUPERIORITY|||||||0.724|||||||Mixed Models Analysis|We ran linear mixed models, p-value reflects a group by session interaction for the UGRS composite scores.||Null hypothesis: no difference between groups. Power analyses of an effect size (d=.70) previously reported for within and between-subjects analyses of questionnaire outcomes (i.e., depressive symptoms, grief rumination, perceived stress, reappraisal usage) indicate over 95% power (α=.05) to detect within-group effects and 90% power (α=0.05) for between-group effects should be achieved with 36 per group.||||0.724
71094845|NCT04822194|141697804|SUPERIORITY|||||||0.835|||||||Mixed Models Analysis|Ran linear mixed model on counterfactuals adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.835
71094846|NCT04822194|141697804|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|Ran linear mixed model on injustice adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups.||||0.090
71094847|NCT04822194|141697804|SUPERIORITY|||||||0.983|||||||Mixed Models Analysis|Ran linear mixed model on meaning adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.983
71094848|NCT04822194|141697804|SUPERIORITY|||||||0.76|||||||Mixed Models Analysis|Ran linear mixed model on reaction adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.760
71094849|NCT04822194|141697804|SUPERIORITY|||||||0.402|||||||Mixed Models Analysis|Ran linear mixed model on relations adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups.||||0.402
70920687|NCT04452318|141332031|SUPERIORITY||Odds Ratio (OR)|0.54|||=|0.046|TWO_SIDED|95.0|0.299|0.989|||Regression, Logistic|||||0.989|0.299|= 0.0460
70920688|NCT04452318|141332032|SUPERIORITY||Odds Ratio (OR)|0.47|||=|0.0721|TWO_SIDED|95.0|0.207|1.07|||Regression, Logistic|||||1.070|0.207|= 0.0721
70920689|NCT04452318|141332033|SUPERIORITY||||||=|0.026|||||||Stratified Wilcoxon Rank Sum Test|||||||= 0.0260
70920690|NCT04452318|141332034|SUPERIORITY||||||=|0.0614|||||||Stratified Wilcoxon Rank Sum Test|||||||= 0.0614
70920691|NCT04452318|141332035|SUPERIORITY||LS mean difference|-1.461|STANDARD_ERROR_OF_MEAN|0.337|<|0.0001|TWO_SIDED|95.0|-2.127|-0.795|||ANCOVA|||||-0.795|-2.127|< 0.0001
70920692|NCT04452318|141332036|SUPERIORITY||LS mean difference|-0.85|STANDARD_ERROR_OF_MEAN|0.279|=|0.0026|TWO_SIDED|95.0|-1.4|-0.3|||ANCOVA|||||-0.300|-1.400|= 0.0026
70920693|NCT04452318|141332037|SUPERIORITY||LS mean difference|-0.94|STANDARD_ERROR_OF_MEAN|0.193|<|0.0001|TWO_SIDED|95.0|-1.321|-0.559|||ANCOVA|||||-0.559|-1.321|< 0.0001
70920694|NCT04452318|141332038|SUPERIORITY||Difference of LS Mean|-26.045|STANDARD_ERROR_OF_MEAN|6.041|<|0.0001|TWO_SIDED|95.0|-37.973|-14.117|||ANCOVA|||||-14.117|-37.973|< 0.0001
70920695|NCT04452318|141332039|SUPERIORITY||Difference of LS Mean|-1.395|STANDARD_ERROR_OF_MEAN|0.338|<|0.0001|TWO_SIDED|95.0|-2.063|-0.727|||ANCOVA|||||-0.727|-2.063|< 0.0001
70920696|NCT04452318|141332040|SUPERIORITY||||||=|0.0138|||||||Stratified Wilcoxon Rank Sum Test|||||||= 0.0138
70920697|NCT04452318|141332041|OTHER||||||=|0.0292|||||||Fisher Exact|||Testing if there is an association between the observed results and treatment received||||= 0.0292
70920698|NCT04452318|141332042|OTHER||||||=|0.2466|||||||Fisher Exact|||Testing if there is an association between the observed results and treatment received||||= 0.2466
70920699|NCT04452318|141332043|SUPERIORITY||||||=|0.7861|||||||Stratified Wilcoxon Rank Sum test|||||||= 0.7861
70920700|NCT04452318|141332044|SUPERIORITY||||||=|0.0842|||||||Stratified Wilcoxon Rank Sum test|||||||= 0.0842
70920701|NCT01828554|141332053|OTHER|||||||0.4882||||||A paired t-test will be used to compare the PK parameters between the full weight and limited weight based dosing.|t-test, 2 sided|||The null hypothesis that the AUC from cycle 1 day 1 (based on ideal body weight) is equal to the AUC from cycle 1 day 9 (based on actual body weight) was tested against the alternative hypothesis that the AUCs are not equal. A linear mixed effect model with patient specific random effects was conducted||||0.4882
70920702|NCT01828554|141332054|OTHER|||||||0.7497||||||A paired t-test will be used to compare the PK parameters between the full weight and limited weight based dosing.|t-test, 2 sided|||||||0.7497
71094850|NCT04822194|141697805|SUPERIORITY|||||||0.092|||||||Mixed Models Analysis|We ran a linear mixed model, p-value reflects group by session interaction||Null hypothesis: no difference between groups||||0.092
71094851|NCT04822194|141697806|SUPERIORITY|||||||0.585|||||||Mixed Models Analysis|Ran a linear mixed model, p-value reflects group by session interaction||Null hypothesis: no difference between groups||||0.585
71094852|NCT04822194|141697807|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|Ran linear mixed model, p-value reflects group by session interaction||Null hypothesis: no difference between groups||||0.70
71094853|NCT04822194|141697808|SUPERIORITY|||||||0.696|||||||Mixed Models Analysis|Ran linear mixed model on emotional problems adjusted for covariates, p-value above reflects group by session interaction||Null hypothesis: no difference between groups.||||0.696
71094854|NCT04822194|141697808|SUPERIORITY|||||||0.452|||||||Mixed Models Analysis|Ran linear mixed model on emotional well-being adjusted for covariates, p-value reflects group by session interaction||Null hypothesis: no difference between groups||||0.452
71094855|NCT04822194|141697808|SUPERIORITY|||||||0.65|||||||Mixed Models Analysis|Ran a linear mixed model on energy adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.650
71094856|NCT04822194|141697808|SUPERIORITY|||||||0.224|||||||Mixed Models Analysis|Ran linear mixed model on general health perceptions adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.224
71094857|NCT04822194|141697808|SUPERIORITY|||||||0.256|||||||Mixed Models Analysis|Ran linear mixed model on pain adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference in groups||||0.256
71094858|NCT04822194|141697808|SUPERIORITY|||||||0.984|||||||Mixed Models Analysis|Ran linear mixed model on physical function adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.984
71094859|NCT04822194|141697808|SUPERIORITY|||||||0.363|||||||Mixed Models Analysis|Ran linear mixed model on physical health adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.363
71094860|NCT04822194|141697808|SUPERIORITY|||||||0.045|||||||Mixed Models Analysis|Ran linear mixed model on social functioning adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.045
71094861|NCT04822194|141697809|SUPERIORITY|||||||0.422|||||||ANCOVA|Ran a repeated measures ANCOVA of logged IL-6 serum, p-value above reflects time by ER group interaction effect.||Null hypothesis: no difference between groups||||0.422
71094862|NCT04822194|141697809|SUPERIORITY|||||||0.438|||||||ANCOVA|Ran a repeated measures ANCOVA of TNFα, p-value above reflects time by ER group interaction effect.||Null hypothesis: no difference between groups||||0.438
71094863|NCT00248547|141697819|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||Wilcoxon Rank Sum Test|||||||0.041
70973611|NCT01100944|141454007|SUPERIORITY_OR_OTHER|||||||0.0009||||||Fold change at Cycle 1 Day 2 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.0009
71094864|NCT00294398|141697823|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||t-test, 2 sided|||||||0.87
71094865|NCT02965833|141697825|SUPERIORITY||||||=|0.0073|||||||Mixed Models Analysis|||||||=0.0073
71094866|NCT05643794|141697838|SUPERIORITY||Difference from Placebo|-0.54||||0.129|TWO_SIDED|95.0|-1.24|0.16|||Longitudinal linear mixed effect model||The difference presented is RLZ 12 weeks minus Placebo.|||0.16|-1.24|0.129
71094867|NCT05643794|141697841|SUPERIORITY||Difference from Placebo|-0.51||||0.358|TWO_SIDED|95.0|-1.6|0.58|||Longitudinal mixed effects model||The difference presented is RLZ 24 weeks minus PBO 24 weeks.|||0.58|-1.60|0.358
71094868|NCT05643794|141697842|SUPERIORITY||Difference from Placebo|-8.4||||0.003|TWO_SIDED|95.0|-13.84|-2.96|||Longitudinal mixed effects model||The difference presented is RLZ 12 weeks minus Placebo|||-2.96|-13.84|0.003
70973612|NCT01100944|141454007|SUPERIORITY_OR_OTHER|||||||0.0001||||||Fold change at Cycle 1 Day 3 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.0001
70973613|NCT01100944|141454008|SUPERIORITY_OR_OTHER|||||||0.95||||||Fold change at Cycle 2 Day 1 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.95
70973614|NCT01100944|141454008|SUPERIORITY_OR_OTHER|||||||0.0001||||||Fold change at Cycle 1 Day 2 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.0001
70973615|NCT01100944|141454008|SUPERIORITY_OR_OTHER|||||||0.0001||||||Fold change at Cycle 1 Day 3 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.0001
70973616|NCT02296242|141454017|OTHER||Highest dose (mg) with no DLTs.|600.0|||||TWO_SIDED|||||||||In Part 1, 2 patients experienced DLTs in the 750 mg b.i.d. treatment group (2/7; 29%). There were no dose-limiting toxicities in the 600 mg b.i.d. group or 300 mg b.i.d. group. Therefore, based on these results, 600 mg b.i.d. was selected as the MTD dose (and RP2D dose) which was used as the treatment dose in Part 2 of the study.||||
70973617|NCT01077973|141454022|SUPERIORITY_OR_OTHER||Least-square (LS) mean difference|-1.12||||0.299|TWO_SIDED|95.0|-3.23|1.0||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR), gender and treatment-by-baseline PSR terms.|ANOVA|||Treatment difference (Ibuprofen sodium-placebo) and 95 percent (%) confidence interval (CI): based on LS means from analysis of variance (ANOVA). Type I error was controlled at 0.05 significance level (2-sided) by stating pair wise comparisons significant only if overall treatment effect among 3 treatment groups was significant and testing in a sequential order Ibuprofen sodium versus (vs.) placebo for SPRID 0-3 then Ibuprofen sodium vs. Ibuprofen (Motrin IB) for time to meaningful relief.||1.00|-3.23|0.299
70973618|NCT01077973|141454023|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.193|TWO_SIDED|95.0|0.52|1.14||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Hazard Ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model. Type I error was controlled at 0.05 significance level (2-sided) by stating pair wise comparisons significant only if overall treatment effect among 3 treatment groups was significant and testing in a sequential order Ibuprofen sodium vs. placebo for SPRID 0-3 then Ibuprofen sodium vs. Ibuprofen (Motrin IB) for time to meaningful relief.||1.14|0.52|0.193
71094869|NCT05643794|141697843|SUPERIORITY||Differences from Placebo|0.05||||0.878|TWO_SIDED|95.0|-0.55|0.64|||Longitudinal mixed effects model||The differences presented is RLZ 12 weeks minus Placebo.|||0.64|-0.55|0.878
71094870|NCT05643794|141697844|SUPERIORITY||Difference from Placebo|-0.28||||0.352|TWO_SIDED|95.0|-0.86|0.31|||Longitudinal mixed effects model||The difference presented is RLZ 12 weeks minus Placebo.|||0.31|-0.86|0.352
71094871|NCT04766333|141697866|SUPERIORITY||Odds Ratio (OR)|0.45|||<|0.05|TWO_SIDED|95.0|0.17|1.23|||Regression, Logistic||Healthcare Arm is the reference category|||1.23|0.17|<0.05
71094872|NCT00639379|141697880|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.65|Odds Ratio (OR)|0.967|||||TWO_SIDED|98.98|0.436|0.967|||Regression, Logistic||Odds ratio is senofilcon A toric / alphafilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for proportion of eyes with lens orientation within 5 degrees.||0.967|0.436|
71094873|NCT00639379|141697881|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.65|Odds Ratio (OR)|1.416|||||TWO_SIDED|98.98|0.68|1.416|||Regression, Logistic||Odds ratio is senofilcon A toric / alphafilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for proportion of eyes with lens stability within 5 degrees.||1.416|0.680|
71094874|NCT00639379|141697882|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.4|Mean Difference (Final Values)|0.1868|STANDARD_ERROR_OF_MEAN|0.0921|||TWO_SIDED|98.98|-0.0517|0.1868|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus alphafilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for lens comfort.||0.1868|-0.0517|
71154093|NCT03069352|141800762|SUPERIORITY||Hazard Ratio (HR)|0.749||||0.114|TWO_SIDED|95.0|0.524|1.071|||Log Rank|Log-rank test stratified by AML status (de novo, secondary) and age (18 - \< 75, ≥ 75).|The hazard ratio was estimated using the Cox proportional hazards model, stratified by AML status (de novo, secondary) and age (18 - \< 75, ≥ 75).|||1.071|0.524|0.114
70973619|NCT01077973|141454024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.304|TWO_SIDED|95.0|0.5|1.24||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.24|0.50|0.304
70973620|NCT01077973|141454024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.936|TWO_SIDED|95.0|0.65|1.59||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.59|0.65|0.936
70973621|NCT01077973|141454025|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.072|TWO_SIDED|95.0|0.41|1.04||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.04|0.41|0.072
70973622|NCT01077973|141454025|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.652|TWO_SIDED|95.0|0.58|1.41||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.41|0.58|0.652
70973623|NCT01077973|141454025|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.108|TWO_SIDED|95.0|0.49|1.07||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.07|0.49|0.108
70973624|NCT01077973|141454026|SUPERIORITY_OR_OTHER||LS mean difference|-0.19||||0.402|TWO_SIDED|95.0|-0.65|0.26||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.26|-0.65|0.402
70973625|NCT01077973|141454026|SUPERIORITY_OR_OTHER||LS mean difference|-0.19||||0.407|TWO_SIDED|95.0|-0.64|0.26||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.26|-0.64|0.407
70973626|NCT01077973|141454026|SUPERIORITY_OR_OTHER||LS mean difference|0.0||||0.991|TWO_SIDED|95.0|-0.38|0.37||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.37|-0.38|0.991
71032544|NCT00836056|141574178|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|95.96||||||90.0|90.77|101.46|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.46|90.77|
71032545|NCT02648347|141574199|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.048|||TWO_SIDED|95.0|-0.04|0.15||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||0.15|-0.04|
71032546|NCT02648347|141574200|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per Food and Drug Administration \[FDA\]) and 1.3 (per European Medicines Agency \[EMA\]).|Hazard Ratio (HR)|1.16|||=|0.205|TWO_SIDED|95.0|0.955|1.412|||Log Rank|||Statistical analysis from study AKB-6548-CI-0014 has been reported in this section.||1.412|0.955|=0.2050
71032547|NCT02648347|141574200|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.17|||=|0.0725|TWO_SIDED|95.0|1.012|1.355|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 382 and 344 respectively; median time to first event (Q1, Q3) = 50.07 (23.00, 82.86) weeks versus 51.93 (27.79, 91.00) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.355|1.012|=0.0725
71032548|NCT02648347|141574201|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.052|||TWO_SIDED|95.0|-0.06|0.14||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||0.14|-0.06|
71032549|NCT02648347|141574202|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.16|||=|0.1743|TWO_SIDED|95.0|0.966|1.382|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0014 has been reported in this section.||1.382|0.966|=0.1743
71032550|NCT02648347|141574202|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.11|||=|0.2305|TWO_SIDED|95.0|0.972|1.267|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first MACE plus hospitalization for heart failure or thromboembolic events excluding vascular access thrombosis for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 451 and 424 respectively; median time to first event (Q1, Q3) = 42.86 (19.71, 73.43) weeks versus 43.86 (21.36, 80.43) weeks, respectively.||1.267|0.972|=0.2305
71032551|NCT02648347|141574203|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.19|||=|0.3154|TWO_SIDED|95.0|0.901|1.564|||Gray's Test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0014 has been reported in this section.||1.564|0.901|=0.3154
71094875|NCT00639379|141697883|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.4|Mean Difference (Final Values)|-0.01185|STANDARD_ERROR_OF_MEAN|0.08566|||TWO_SIDED|98.98|-0.2337|-0.01185|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus alphafilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for subjective vision.||-0.01185|-0.2337|
71094876|NCT00639379|141697884|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.5|Mean Difference (Final Values)|-0.01267|STANDARD_ERROR_OF_MEAN|0.01265|||TWO_SIDED|98.98|-0.01267|0.01986|||||The mean difference was calculated as senofilcon A toric minus alphafilcon A toric.|Alternative hypothesis is senofilcon A toric is non-inferior to alphafilcon A toric by having a lower level of corneal staining.||0.01986|-0.01267|
71094877|NCT02400736|141697887|SUPERIORITY|"Proportion of steady workers in each group was analyzed using a logistic regression model to calculate an odds ratio and 95% Confidence Interval. Adhering to the principle of intent-to-treat, participants were retained in the arm to which they were randomized for the 12-month follow-up period despite discontinuing the treatment intervention or exiting the study early. Missing data was counted as not worked."|Odds Ratio (OR)|2.49||||0.02|TWO_SIDED|95.0|1.14|5.43||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|Chi-squared|||Using SamplePower 3.0 to estimate the statistical power, the target sample size of 120 (60 per group) provided 84% power to detect a 25% or greater absolute difference between groups in the percent of participants achieving 'steady worker' status (e.g., 40% in IPS vs. 15% in control arm), at the .05 level of significance, assuming a 10% attrition.||5.43|1.14|0.02
71094878|NCT02400736|141697888|SUPERIORITY|Intent to treat analysis.||||||0.003||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|t-test, 2 sided|||Total mean time worked was compared using an analysis of variance (ANOVA).||||0.003
71094879|NCT02400736|141697889|SUPERIORITY|||||||0.005||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|Mixed Models Analysis|||intent to treat analysis||||0.005
71094880|NCT02400736|141697890|SUPERIORITY|a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.||||||0.033|||||||t-test, 2 sided|||||||0.033
71094881|NCT02400736|141697891|SUPERIORITY|||||||0.853||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|Mixed Models Analysis|Effect of treatment on outcome was analyzed using longitudinal mixed-effects regression model.Group by time interaction tested for treatment effect.||||||0.853
71094882|NCT02400736|141697892|SUPERIORITY|a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.||||||0.004|||||||t-test, 2 sided|||||||0.004
71154094|NCT03069352|141800762|SUPERIORITY||Hazard Ratio (HR)|0.743||||0.103|TWO_SIDED|95.0|0.521|1.061|||Log Rank|Unstratified analysis|The hazard ratio was estimated using the Cox proportional hazards model.|||1.061|0.521|0.103
70920703|NCT03951805|141332057|OTHER||Treatment difference|0.76||||0.7675|TWO_SIDED|95.0|-4.28|5.8|||ANCOVA|||The response and change from baseline in response during the last two weeks of treatment (week 15 and 16) are analysed using an analysis of covariance (ANCOVA) model with treatment and SGLT2i use as fixed factors, and baseline response as covariate. Missing endpoint values are imputed using multiple imputation based on own treatment arm with baseline response as a covariate. Each imputed dataset is analysed separately and estimates are combined using Rubin's rules.||5.80|-4.28|0.7675
71154095|NCT03069352|141800763|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||<0.001
71154096|NCT03069352|141800763|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71154097|NCT03069352|141800764|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||<0.001
71154098|NCT03069352|141800764|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
70920704|NCT03951805|141332057|OTHER||Treatment difference|7.08||||0.0051|TWO_SIDED|95.0|2.12|12.04|||ANCOVA|||The response and change from baseline in response during the last two weeks of treatment (week 15 and 16) are analysed using an analysis of covariance (ANCOVA) model with treatment and SGLT2i use as fixed factors, and baseline response as covariate. Missing endpoint values are imputed using multiple imputation based on own treatment arm with baseline response as a covariate. Each imputed dataset is analysed separately and estimates are combined using Rubin's rules.||12.04|2.12|0.0051
70920705|NCT03951805|141332057|OTHER||Treatment difference|5.01||||0.0519|TWO_SIDED|95.0|-0.04|10.05|||ANCOVA|||The response and change from baseline in response during the last two weeks of treatment (week 15 and 16) are analysed using an analysis of covariance (ANCOVA) model with treatment and SGLT2i use as fixed factors, and baseline response as covariate. Missing endpoint values are imputed using multiple imputation based on own treatment arm with baseline response as a covariate. Each imputed dataset is analysed separately and estimates are combined using Rubin's rules.||10.05|-0.04|0.0519
70920706|NCT03684044|141332177|SUPERIORITY||Median Difference (Net)|-2.7||||0.4666|TWO_SIDED|95.0|-53.4|25.9|||Gehan Wilcoxon|The Gehan Wilcoxon test was used to analyze the TTCI data because the proportional hazards assumption was violated||||25.9|-53.4|0.4666
70920707|NCT03684044|141332178|SUPERIORITY|||||||0.6326|||||||Cochran-Mantel-Haenszel|Statistic was stratified by region, NEWS2 at baseline (≤7, \>7), and time from symptom onset to study treatment (≤48 hours, \>48 hours)||||||0.6326
70920708|NCT03684044|141332179|SUPERIORITY||Mean Difference (Net)|-6.8||||0.3272|TWO_SIDED|95.0|-50.9|17.7|||Gehan Wilcoxon|The Gehan Wilcoxon test was used to analyze the TTCI data because the proportional hazards assumption was violated||||17.7|-50.9|0.3272
70920709|NCT04629950|141332223|SUPERIORITY|||||||0.395||||||P value not adjusted for multiple comparisons,|t-test, 2 sided|||||||0.395
70920710|NCT04629950|141332223|SUPERIORITY|||||||0.41||||||P values not adjusted for multiple comparisons.|t-test, 2 sided|||||||0.410
70920711|NCT04629950|141332224|SUPERIORITY|||||||0.691|||||||Fisher Exact|||||||0.691
70920712|NCT04629950|141332224|SUPERIORITY|||||||1||||||P values not adjusted for multiple comparisons.|Fisher Exact|||||||1
70920713|NCT04629950|141332225|SUPERIORITY|||||||0.758|||||||t-test, 2 sided|P value not adjusted for multiple comparisons,||||||0.758
70920714|NCT04629950|141332225|SUPERIORITY|||||||0.247||||||P values not adjusted for multiple comparisons.|Fisher Exact|||Data represent change values.||||0.247
71154099|NCT03069352|141800765|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||<0.001
71154100|NCT03069352|141800765|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
70973627|NCT01077973|141454026|SUPERIORITY_OR_OTHER||LS mean difference|-0.25||||0.313|TWO_SIDED|95.0|-0.75|0.24||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.24|-0.75|0.313
71032552|NCT02648347|141574203|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.16|||=|0.2531|TWO_SIDED|95.0|0.947|1.42|||Gray's Test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first cardiovascular MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 198 and 178 respectively; median time to first event (Q1, Q3) = 45.57 (21.71, 73.29) weeks versus 47.36 (20.00, 88.43) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.420|0.947|=0.2531
71032553|NCT02648347|141574204|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.13|||=|0.5991|TWO_SIDED|95.0|0.808|1.594|||Gray's test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0014 has been reported in this section.||1.594|0.808|=0.5991
71032554|NCT02648347|141574204|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.01|||=|0.8613|TWO_SIDED|95.0|0.792|1.293|||Gray's test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first cardiovascular death for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 127 and 131 respectively; median time to first event (Q1, Q3) = 48.29 (28.86, 76.14) weeks versus 48.43 (21.29, 92.29) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.293|0.792|=0.8613
71032555|NCT02648347|141574205|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.11|||=|0.4388|TWO_SIDED|95.0|0.902|1.375|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0014 has been reported in this section.||1.375|0.902|=0.4388
70973628|NCT01077973|141454026|SUPERIORITY_OR_OTHER||LS mean difference|-0.12||||0.621|TWO_SIDED|95.0|-0.62|0.37||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.37|-0.62|0.621
70973629|NCT01077973|141454026|SUPERIORITY_OR_OTHER||LS mean difference|-0.13||||0.533|TWO_SIDED|95.0|-0.54|0.28||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.28|-0.54|0.533
70973630|NCT01077973|141454026|SUPERIORITY_OR_OTHER||LS mean difference|-0.25||||0.352|TWO_SIDED|95.0|-0.79|0.28||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.28|-0.79|0.352
70973631|NCT01077973|141454026|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.573|TWO_SIDED|95.0|-0.69|0.38||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.38|-0.69|0.573
71032556|NCT02648347|141574205|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.09|||=|0.4577|TWO_SIDED|95.0|0.93|1.274|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first all-cause mortality for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 319 and 307 respectively; median time to first event (Q1, Q3) = 52.14 (28.71, 84.71) weeks versus 53.00 (30.71, 94.14) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.274|0.930|=0.4577
71094883|NCT02400736|141697893|SUPERIORITY|||||||0.47||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|Mixed Models Analysis|Effect of treatment on outcome was analyzed using longitudinal mixed-effects regression model.Group by time interaction tested for treatment effect.||The effect of treatment on each of secondary outcome measures were analyzed using a longitudinal mixed-effects regression model. The group by time interaction tested for the treatment effect.||||0.47
71094884|NCT02400736|141697894|SUPERIORITY|||||||0.062||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|t-test, 2 sided|||||||0.062
71154101|NCT03069352|141800766|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||<0.001
71154102|NCT03069352|141800766|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
70973632|NCT01077973|141454026|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.657|TWO_SIDED|95.0|-0.54|0.34||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.34|-0.54|0.657
71094885|NCT02400736|141697895|SUPERIORITY||||||>|0.3||||||a priori threshold for statistical significance p \</= 0.05 or lower. No adjustments were made for multiple comparisons.|ANOVA|||||||>0.3
71094886|NCT02400736|141697896|SUPERIORITY|||||||0.001||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|t-test, 2 sided|||||||0.001
71094887|NCT02400736|141697897|SUPERIORITY|||||||0.006||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|Chi-squared|||||||0.006
71154103|NCT03069352|141800767|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||<0.001
70973633|NCT01077973|141454027|SUPERIORITY_OR_OTHER||LS mean difference|-0.11||||0.382|TWO_SIDED|95.0|-0.36|0.14||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.14|-0.36|0.382
70973634|NCT01077973|141454027|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.242|TWO_SIDED|95.0|-0.39|0.1||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.10|-0.39|0.242
71154104|NCT03069352|141800767|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
70920715|NCT04629950|141332226|SUPERIORITY|||||||0.316||||||P values were not adjusted for multiple comparisons.|t-test, 2 sided|||||||0.316
70920716|NCT04629950|141332226|SUPERIORITY|||||||0.605||||||P values not adjusted for multiple comparisons.|t-test, 2 sided|||Data represent change values.||||0.605
70920717|NCT04629950|141332227|SUPERIORITY|||||||0.192||||||P value not adjusted for multiple comparisons,|t-test, 2 sided|||Mean Reduction in Average Itch||||0.192
70920718|NCT04629950|141332227|SUPERIORITY|||||||0.392||||||P value not adjusted for multiple comparisons,|t-test, 2 sided|||Mean Reduction in Average Itch. Data represent change values.||||0.392
70920719|NCT04629950|141332227|SUPERIORITY|||||||0.347||||||P values not adjusted for multiple comparisons.|t-test, 2 sided|||Mean Reduction in Maximum Itch||||0.347
70920720|NCT04629950|141332227|SUPERIORITY|||||||0.572||||||P value not adjusted for multiple comparisons,|t-test, 2 sided|||Mean Reduction in Maximum Itch. Data represent change values.||||0.572
70920721|NCT04629950|141332228|OTHER|||||||0.359|||||||Wilcoxon (Mann-Whitney)|||||||0.359
70920722|NCT04629950|141332229|OTHER|||||||0.141|||||||Wilcoxon (Mann-Whitney)|||||||0.141
70920723|NCT04629950|141332230|OTHER|||||||0.582|||||||Wilcoxon (Mann-Whitney)|||||||0.582
70920724|NCT04629950|141332231|OTHER|||||||0.713|||||||Wilcoxon (Mann-Whitney)|||||||0.713
70920725|NCT04629950|141332232|OTHER|||||||0.346|||||||Wilcoxon (Mann-Whitney)|||||||0.346
70920726|NCT04629950|141332233|OTHER|||||||0.149|||||||Wilcoxon (Mann-Whitney)|||||||0.149
70920727|NCT04629950|141332234|OTHER|||||||0.221|||||||Wilcoxon (Mann-Whitney)|||Analysis for Average Itch Over the Preceding 3 Days||||0.221
70920728|NCT04629950|141332234|OTHER|||||||0.286|||||||Wilcoxon (Mann-Whitney)|||Analysis is for the Maximum Itch of the Preceding 7 Days||||0.286
70920729|NCT04629950|141332235|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||Analysis for Average Itch Over the Preceding 3 Days||||1
70920730|NCT04629950|141332235|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||Analysis is for the Maximum Itch of the Preceding 7 Days||||1
70920731|NCT01198145|141332245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
70920732|NCT01198145|141332246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.23|||||||Chi-squared|||Comparing Tenesmus During RT||||0.23
70920733|NCT01198145|141332246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64|||||||Chi-squared|||Comparing Tenesmus after RT||||0.64
70920734|NCT01198145|141332246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Chi-squared|||Comparing abdominal pain during RT.||||0.30
70920735|NCT01198145|141332246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Chi-squared|||Comparing abdominal pain after RT||||0.02
70920736|NCT01198145|141332246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7|||||||Chi-squared|||Comparing constipation during RT||||0.70
70920737|NCT01198145|141332246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63|||||||Chi-squared|||Comparing constipation after RT||||0.63
70920738|NCT01198145|141332246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44|||||||Chi-squared|||Comparing diarrhea during RT||||0.44
70920739|NCT01198145|141332246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48|||||||Chi-squared|||Comparing diarrhea after RT||||0.48
70920740|NCT01198145|141332246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.38|||||||Chi-squared|||Comparing rectal bleeding during RT||||0.38
70920741|NCT01198145|141332246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|||||||Chi-squared|||||||0.15
70920742|NCT01198145|141332247|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||Result comparing Arm I and Arm II during RT.||||0.56
70920743|NCT01198145|141332247|SUPERIORITY_OR_OTHER_LEGACY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Result comparing Arm I and Arm II after RT.||||0.74
70920744|NCT00891436|141332254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.5|>|0.1||95.0|||||t-test, 2 sided|||paired t-test was used for the data analysis||||>0.1
70920745|NCT00891436|141332254|NON_INFERIORITY_OR_EQUIVALENCE|t-test showed no different between the 2 groups.|Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.5|>|0.1||95.0|||||t-test, 2 sided|||||||>0.1
70920746|NCT01381406|141332262|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.772||||0.007|TWO_SIDED|95.0|0.641|0.93||COPD-Related Adjusted Multivariate Outcomes in the Follow-Up Period by Cohort (reference cohort = TIO) for Any COPD Exacerbation|Regression, Logistic|||||0.930|0.641|0.007
70920747|NCT01381406|141332262|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.622||||0.146|TWO_SIDED|95.0|0.328|1.18||COPD-Related Adjusted Multivariate Outcomes in the Follow-Up Period by Cohort (reference cohort = TIO) for Severe COPD Exacerbations|Regression, Logistic|||||1.180|0.328|0.146
70920748|NCT01381406|141332262|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.763||||0.013|TWO_SIDED|95.0|0.646|0.949||COPD-Related Adjusted Multivariate Outcomes in the Follow-Up Period by Cohort (reference cohort = TIO) for Moderate COPD Exacerbations|Regression, Logistic|||||0.949|0.646|0.013
70920749|NCT01066026|141332265|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|pilot study.|descritive variables|50.0|||<|0.0001|TWO_SIDED|95.0|5.0|95.0|||McNemar||50 was the percentage of hematomas expected for standard needle group.|||95|5|<0.0001
70973635|NCT01077973|141454027|SUPERIORITY_OR_OTHER||LS mean difference|0.04||||0.72|TWO_SIDED|95.0|-0.17|0.24||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.24|-0.17|0.720
71032557|NCT01639222|141574216|SUPERIORITY_OR_OTHER||Calcium-Vitamin D/Reference (%)|179.72|||||TWO_SIDED|95.0|157.16|205.52|||||Point estimates and 95% CIs for the treatment difference ratio (Calcium-Vitamin D/reference treatment) are provided on the original scale as a ratio \* 100%.|The primary parameters were analysed in a mixed effects general linear model of the logtransformed values, including treatment as a fixed effect and subject as a random effect. The objective of the trial was met if the treatment contrast was statistically significantly different from 0 in the appropriate direction in a 2-sided test on a 5% significance level for both parameters. The 5% significance level for both primary parameters was not adjusted for multiple testing.||205.52|157.16|
71032558|NCT01639222|141574217|SUPERIORITY_OR_OTHER||Calcium-Vitamin D/Reference (%)|71.77|||||TWO_SIDED|95.0|68.83|74.84|||||Point estimate and 95% CI for the treatment difference ratio (Calcium-Vitamin D /reference treatment) are provided on the original scale as a ratio \* 100%.|||74.84|68.83|
71032559|NCT01639222|141574218|SUPERIORITY_OR_OTHER||Calcium-Vitamin D/Reference (%)|156.74|||||TWO_SIDED|95.0|121.66|201.93|||||Point estimates and 95% CIs for the treatment difference ratio (Calcium-Vitamin D / reference treatment) are provided on the original scale as a ratio \* 100%.|||201.93|121.66|
71032560|NCT01265056|141574252|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71032561|NCT01265056|141574252|SUPERIORITY||||||<|0.04|||||||Regression, Logistic|||||||<0.04
71032562|NCT01265056|141574253|SUPERIORITY||||||<|0.8|||||||t-test, 2 sided|||||||<0.8
71032563|NCT01265056|141574254|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
71032564|NCT01416584|141574255|SUPERIORITY||Odds Ratio (OR)|1.4||||0.6|TWO_SIDED|95.0|0.4|4.83|||General Estimating Equation (GEE)|||||4.83|0.40|0.60
71032565|NCT01416584|141574255|SUPERIORITY||Odds Ratio (OR)|1.1||||0.88|TWO_SIDED|95.0|0.32|3.73|||General Estimating Equation (GEE)|||||3.73|0.32|0.88
71032566|NCT01416584|141574255|SUPERIORITY||Odds Ratio (OR)|1.27||||0.64|TWO_SIDED|95.0|0.36|4.46|||General Estimating Equation (GEE)|||||4.46|0.36|0.64
71032567|NCT01416584|141574256|SUPERIORITY||Odds Ratio (OR)|0.39||||0.02|TWO_SIDED|95.0|0.38|0.41|||General Estimating Equation (GEE)|||||0.41|0.38|0.02
71032568|NCT01416584|141574256|SUPERIORITY||Odds Ratio (OR)|0.73||||0.39|TWO_SIDED|95.0|0.34|1.57|||General Estimating Equation (GEE)|||||1.57|0.34|0.39
71032569|NCT01416584|141574256|SUPERIORITY||Odds Ratio (OR)|1.86||||0.1|TWO_SIDED|95.0|1.53|2.26|||General Estimating Equation (GEE)|||||2.26|1.53|0.10
71032570|NCT01416584|141574257|SUPERIORITY||Odds Ratio (OR)|0.37||||0.02|TWO_SIDED|95.0|0.36|0.38|||General Estimating Equation (GEE)|||||0.38|0.36|0.02
71094888|NCT02383173|141697900|OTHER|||||||0.445|||||||Generalized Estimating Equation (GEE)|Sandwich estimators were used to adjust for the small number of clusters.||Generalized Estimating Equation (GEE) analyses of post-intervention data were used to account for clustering. We adjusted for age, race, cancer, length of stay and study year.||||0.445
71032571|NCT01416584|141574257|SUPERIORITY||Odds Ratio (OR)|0.39||||0.02|TWO_SIDED|95.0|0.38|0.41|||General Estimating Equation (GEE)|||||0.41|0.38|0.02
71094889|NCT03677401|141697915|SUPERIORITY|P-value from a Cochran-Mantel- Haenszel (CMH) test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.||||||0.158|||||||Cochran-Mantel-Haenszel|||At Week 10||||0.158
71094890|NCT03677401|141697916|SUPERIORITY|P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.||||||0.75|||||||Cochran-Mantel-Haenszel|||At Week 4||||0.750
71154105|NCT03069352|141800768|OTHER||LS Mean Difference|-4.507|STANDARD_ERROR_OF_MEAN|2.068|||TWO_SIDED|95.0|-8.6|-0.41|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 3, Day 1||-0.41|-8.60|
71032572|NCT01416584|141574257|SUPERIORITY||Odds Ratio (OR)|1.07||||0.85|TWO_SIDED|95.0|0.2|5.66|||General Estimating Equation (GEE)|||||5.66|0.20|0.85
71032573|NCT01416584|141574258|SUPERIORITY||Odds Ratio (OR)|0.35||||0.01|TWO_SIDED|95.0|0.34|0.35|||General Estimating Equation (GEE)|||||0.35|0.34|0.01
71032574|NCT01416584|141574258|SUPERIORITY||Odds Ratio (OR)|0.41||||0.03|TWO_SIDED|95.0|0.39|0.44|||General Estimating Equation (GEE)|||||0.44|0.39|0.03
71032575|NCT01416584|141574258|SUPERIORITY||Odds Ratio (OR)|0.84||||0.63|TWO_SIDED|95.0|0.42|1.69|||General Estimating Equation (GEE)|||||1.69|0.42|0.63
71032576|NCT01416584|141574259|SUPERIORITY||Odds Ratio (OR)|0.4||||0.01|TWO_SIDED|95.0|0.39|0.4|||General Estimating Equation (GEE)|||||0.40|0.39|0.01
71032577|NCT01416584|141574259|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.37|TWO_SIDED|95.0|0.36|1.55|||General Estimating Equation (GEE)|||||1.55|0.36|0.37
71032578|NCT01416584|141574259|SUPERIORITY||Odds Ratio (OR)|0.53||||0.05|TWO_SIDED|95.0|0.28|1.0|||General Estimating Equation (GEE)|||||1.00|0.28|0.05
71032579|NCT03117296|141574268|OTHER||Rank-Sum|0.05|||<|0.01|TWO_SIDED||||||Fisher Exact|||Univariate 2-group comparisons were performed using χ2 and Fisher's exact tests (when expected cell counts are \<5) for categorical variables, using 2-group t tests and Wilcoxon rank-sum tests (when normality distributions were violated) for continuous variables. Statistical significance was set at P \< .05. All analyses were performed using SAS 9.4 (SAS Institute, Cary, North Carolina).||||<0.01
71032580|NCT00833937|141574285|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|99.7||||||90.0|93.9|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106|93.9|
71032581|NCT00833937|141574286|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|97.8||||||90.0|92.6|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|92.6|
71032582|NCT00833937|141574287|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|97.9||||||90.0|92.7|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|92.7|
71032583|NCT00465270|141574311|OTHER||Cox Proportional Hazard|0.49||||0.08|TWO_SIDED|95.0|0.22|1.11|||Log Rank|||||1.11|0.22|0.08
71032584|NCT00465270|141574313|OTHER||Cox Proportional Hazard|0.55||||0.046|TWO_SIDED|95.0|0.31|0.999|||Log Rank|||||0.999|0.31|0.046
71094891|NCT03677401|141697917|SUPERIORITY|P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation||||||0.674|||||||Cochran-Mantel-Haenszel|||At Week 2||||0.674
71094892|NCT03677401|141697918|SUPERIORITY|P-values, least squares means (LS Mean) and standard deviations (LS SD) from an analysis of covariance (ANCOVA) with treatment group and stratification factor as fixed effects, and baseline value as a covariate.||||||0.06|||||||ANCOVA|||At Week 2||||0.060
71094893|NCT03677401|141697918|SUPERIORITY|||||||0.401||||||P-values, LS Mean and LS SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 4||||0.401
71094894|NCT03677401|141697918|SUPERIORITY|P-values, LS Mean and LS SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.||||||0.185|||||||ANCOVA|||At Week 6||||0.185
71094895|NCT03677401|141697918|SUPERIORITY|P-values, LS Mean and LS SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.||||||0.164|||||||ANCOVA|||At Week 10||||0.164
71032585|NCT01045161|141574428|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.051||||0.019|TWO_SIDED|95.0|0.01|0.09|||ANCOVA|||||0.09|0.01|0.019
71032586|NCT01045161|141574428|SUPERIORITY_OR_OTHER||Least squares mean difference|0.072||||0.0012|TWO_SIDED|95.0|0.03|0.12|||ANCOVA|||||0.12|0.03|0.0012
71032587|NCT01045161|141574430|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.051||||0.0192|TWO_SIDED|95.0|0.01|0.09|||ANCOVA|||||0.09|0.01|0.0192
71094896|NCT03677401|141697919|SUPERIORITY|||||||0.283||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||At Week 2||||0.283
71094897|NCT03677401|141697919|SUPERIORITY|||||||0.701||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||At Week 4||||0.701
71094898|NCT03677401|141697919|SUPERIORITY|||||||0.033||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||At Week 10||||0.033
71094899|NCT03677401|141697920|SUPERIORITY|||||||0.797||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.797
71094900|NCT03677401|141697921|SUPERIORITY|||||||0.845||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.845
71094901|NCT03677401|141697922|SUPERIORITY|||||||0.385||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 2||||0.385
70920750|NCT03447249|141332269|SUPERIORITY||Least Squares (LS) Mean Difference|14.0|||<|0.0001|TWO_SIDED|95.0|12.4|15.7|||Mixed-effects model for repeated measure|||The data presented for Primary endpoint was based on interim analysis at Week 4.||15.7|12.4|<0.0001
70920751|NCT03447249|141332270|SUPERIORITY||LS Mean Difference|14.2|||<|0.0001|TWO_SIDED|95.0|12.6|15.7|||Mixed-effects model for repeated measure|||||15.7|12.6|<0.0001
70920752|NCT03447249|141332271|SUPERIORITY||Rate ratio|0.14|||<|0.0001|TWO_SIDED|95.0|0.09|0.24|||Negative binomial regression model|||||0.24|0.09|<0.0001
70920753|NCT03447249|141332272|SUPERIORITY||LS Mean Difference|-44.6|||<|0.0001|TWO_SIDED|95.0|-47.2|-41.9|||Mixed-effects model for repeated measure|||||-41.9|-47.2|<0.0001
70920754|NCT03447249|141332273|SUPERIORITY||LS Mean Difference|20.1|||<|0.0001|TWO_SIDED|95.0|17.2|23.0|||Mixed-effects model for repeated measure|||||23.0|17.2|<0.0001
70920755|NCT03447249|141332274|SUPERIORITY||LS Mean Difference|1.11|||<|0.0001|TWO_SIDED|95.0|0.91|1.31|||Mixed-effects model for repeated measure|||||1.31|0.91|<0.0001
70920756|NCT03447249|141332275|SUPERIORITY||LS Mean Difference|-43.4|||<|0.0001|TWO_SIDED|95.0|-46.3|-40.5|||Mixed-effects model for repeated measure|||||-40.5|-46.3|<0.0001
70920757|NCT03447249|141332276|SUPERIORITY||LS Mean Difference|17.9|||<|0.0001|TWO_SIDED|95.0|14.5|21.3|||Mixed-effects model for repeated measure|||||21.3|14.5|<0.0001
70920758|NCT03447249|141332278|SUPERIORITY||LS Mean Difference|0.39|||||TWO_SIDED|95.0|0.24|0.54||||||||0.54|0.24|
70920759|NCT03447249|141332279|SUPERIORITY||LS Mean Difference|3.2|||||TWO_SIDED|95.0|2.7|3.8||||||||3.8|2.7|
70920760|NCT02574455|141332284|OTHER||Hazard Ratio (HR)|0.387|||<|0.0001|TWO_SIDED|95.0|0.305|0.492||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies, presence of known brain metastases at study entry, and region.|Log Rank|||||0.492|0.305|<0.0001
70920761|NCT02574455|141332285|OTHER||Hazard Ratio (HR)|0.413|||<|0.0001|TWO_SIDED|95.0|0.33|0.517||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies, presence of known brain metastases at study entry, and region.|Log Rank|||||0.517|0.330|<0.0001
70920762|NCT02574455|141332286|OTHER||Hazard Ratio (HR)|0.481|||<|0.0001|TWO_SIDED|95.0|0.39|0.592||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies and region.|Log Rank|||||0.592|0.390|<0.0001
70920763|NCT02574455|141332287|OTHER||Hazard Ratio (HR)|0.514|||<|0.0001|TWO_SIDED|95.0|0.422|0.625||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies and region.|Log Rank|||||0.625|0.422|<0.0001
70920764|NCT02574455|141332288|OTHER||Odds Ratio (OR)|10.859|||<|0.0001|TWO_SIDED|95.0|5.59|21.095|||Cochran-Mantel-Haenszel|||ORR by IRC Assessment||21.095|5.590|<0.0001
71094902|NCT03677401|141697922|SUPERIORITY|||||||0.786||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 4||||0.786
71094903|NCT03677401|141697922|SUPERIORITY|||||||0.502||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.502
71094904|NCT03677401|141697923|SUPERIORITY|||||||0.197||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 2||||0.197
71032588|NCT01045161|141574430|SUPERIORITY_OR_OTHER||Least Squares Mean difference|0.072||||0.0012|TWO_SIDED|95.0|0.03|0.12|||ANCOVA|||||0.12|0.03|0.0012
71094905|NCT03677401|141697923|SUPERIORITY|||||||0.694||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 4||||0.694
71094906|NCT03677401|141697923|SUPERIORITY|||||||0.916||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.916
71032589|NCT02612337|141574438|SUPERIORITY|The target sample size for each was 160 randomized subjects: 80 in each treatment group stratified by gender. The sample size estimate was chosen to achieve more than 90% power with a significance level of 0.05 2-sided to reject the null hypothesis of no treatment difference for the primary endpoint of DVD.|Risk Ratio (RR)|0.907||||0.623|TWO_SIDED|95.0|0.615|1.339|||Regression, Linear|||The primary efficacy endpoint was compared between OTO-104 and placebo at the 2-tailed 0.05 alpha level using a generalized Poisson linear mixed model. The model included fixed effects for randomized treatment group, sex, study week, a treatment group by study week interaction, and the count of lead-in period DVD standardized to 28 days as a covariate.||1.339|0.615|0.623
71032590|NCT02242201|141574446|SUPERIORITY|||||||0.033|||||||Wilcoxon (Mann-Whitney)|||||||0.033
71094907|NCT02421211|141697925|SUPERIORITY_OR_OTHER||LS means ratio|4.7|||||TWO_SIDED|90.0|3.4|6.5||||||||6.5|3.4|
70920765|NCT02574455|141332288|OTHER||Odds Ratio (OR)|7.363|||<|0.0001|TWO_SIDED|95.0|4.063|13.341|||Cochran-Mantel-Haenszel|||ORR by Investigator Assessment||13.341|4.063|<0.0001
70920766|NCT02574455|141332291|OTHER||Hazard Ratio (HR)|0.407||||0.0683|TWO_SIDED|95.0|0.15|1.107||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies, and region.|Log Rank|||DOR by IRC Assessment||1.107|0.150|0.0683
70920767|NCT02574455|141332291|OTHER||Hazard Ratio (HR)|0.212|||<|0.0001|TWO_SIDED|95.0|0.103|0.435||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies, and region.|Log Rank|||DOR by Investigator Assessment||0.435|0.103|<0.0001
70920768|NCT02574455|141332292|OTHER||Hazard Ratio (HR)|0.317|||<|0.0001|TWO_SIDED|95.0|0.248|0.404||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies and region.|Log Rank|||TTP by Investigator Assessment||0.404|0.248|<0.0001
70920769|NCT02574455|141332293|OTHER||Hazard Ratio (HR)|0.406|||<|0.0001|TWO_SIDED|95.0|0.315|0.525||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies and region.|Log Rank|||TTP by IRC Assessment||0.525|0.315|<0.0001
70920770|NCT02574455|141332294|OTHER||Odds Ratio (OR)|8.543|||<|0.0001|TWO_SIDED|95.0|5.055|14.437|||Cochran-Mantel-Haenszel|||CBR by IRC Assessment||14.437|5.055|<0.0001
70920771|NCT02574455|141332294|OTHER||Odds Ratio (OR)|7.492|||<|0.0001|TWO_SIDED|95.0|4.54|12.364|||Cochran-Mantel-Haenszel|||CBR by Investigator Assessment||12.364|4.540|<0.0001
70920772|NCT02677896|141332298|SUPERIORITY||Cox hazard ratio|0.39|||<|0.0001|TWO_SIDED|95.0|0.3|0.5||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Log Rank||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|rPFS Treatment Comparison||0.50|0.30|<0.0001
70920773|NCT02677896|141332299|SUPERIORITY||Cox proportional hazards model|0.39|||<|0.0001|TWO_SIDED|95.0|0.3|0.5|||Log Rank|||rPFS Treatment Comparision||0.50|0.30|<0.0001
70920774|NCT02677896|141332300|SUPERIORITY||Hazard Ratio (HR)|0.66|||<|0.0001|TWO_SIDED|95.0|0.53|0.81|||Log Rank|P-value from stratified log-rank test.|Significance level is 0.04. Hazard ratio and 95 % CI are estimated by cox proportional hazards model.|||0.81|0.53|<0.0001
70920775|NCT02677896|141332301|SUPERIORITY||Cox hazard ratio|0.19|||<|0.0001|TWO_SIDED|95.0|0.13|0.26||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Log Rank||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Time to PSA Progression Treatment Comparison||0.26|0.13|<0.0001
70973636|NCT01077973|141454027|SUPERIORITY_OR_OTHER||LS mean difference|-0.16||||0.235|TWO_SIDED|95.0|-0.43|0.11||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.11|-0.43|0.235
70973637|NCT01077973|141454027|SUPERIORITY_OR_OTHER||LS mean difference|-0.07||||0.63|TWO_SIDED|95.0|-0.34|0.2||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.20|-0.34|0.630
70973638|NCT01077973|141454027|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.393|TWO_SIDED|95.0|-0.32|0.13||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.13|-0.32|0.393
70973639|NCT01077973|141454027|SUPERIORITY_OR_OTHER||LS mean difference|-0.14||||0.382|TWO_SIDED|95.0|-0.46|0.18||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.18|-0.46|0.382
70973640|NCT01077973|141454027|SUPERIORITY_OR_OTHER||LS mean difference|0.0||||0.995|TWO_SIDED|95.0|-0.32|0.32||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.32|-0.32|0.995
71094908|NCT02421211|141697926|SUPERIORITY_OR_OTHER||LS means ratio|2.3|||||TWO_SIDED|90.0|2.0|2.8||||||||2.8|2.0|
71094909|NCT02421211|141697927|SUPERIORITY_OR_OTHER||LS means ratio|3.1|||||TWO_SIDED|90.0|2.4|3.8||||||||3.8|2.4|
71094910|NCT02421211|141697928|SUPERIORITY_OR_OTHER||LS means ratio|1.7|||||TWO_SIDED|90.0|1.5|2.0||||||||2.0|1.5|
71094911|NCT02421211|141697929|SUPERIORITY_OR_OTHER||LS means ratio|1.6|||||TWO_SIDED|90.0|1.4|1.9||||||||1.9|1.4|
71094912|NCT02421211|141697930|SUPERIORITY_OR_OTHER||LS means ratio|1.7|||||TWO_SIDED|90.0|1.6|2.0||||||||2.0|1.6|
70920776|NCT02677896|141332302|SUPERIORITY||Hazard Ratio (HR)|0.38|||||TWO_SIDED|95.0|0.31|0.48|||||Hazard ratio and 95 % CI are estimated by cox proportional hazards model.|||0.48|0.31|
71094913|NCT01177410|141697945|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.369||||0.0432|TWO_SIDED|95.0|1.027|5.467|||Regression, Logistic|||||5.467|1.027|0.0432
70920777|NCT02677896|141332303|SUPERIORITY||Difference in rate|50.5|||<|0.0001|TWO_SIDED|95.0|45.3|55.7||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Cochran-Mantel-Haenszel|||PSA Undetectable Rate Treatment Comparison||55.7|45.3|<0.0001
70920778|NCT02677896|141332304|SUPERIORITY||Difference in rate|19.3|||<|0.0001|TWO_SIDED|95.0|10.4|28.2||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Cochran-Mantel-Haenszel|||ORR Treatment Comparison||28.2|10.4|<0.0001
70920779|NCT02677896|141332305|SUPERIORITY||Cox hazard ratio|0.88||||0.2162|TWO_SIDED|95.0|0.72|1.08||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Log Rank||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Time to Deterioration of Urinary Symptoms Treatment Comparison||1.08|0.72|0.2162
70920780|NCT02677896|141332306|SUPERIORITY||Cox hazard ratio|0.52||||0.0026|TWO_SIDED|95.0|0.33|0.8|||Log Rank|||Time to SSE Treatment Comparison||0.80|0.33|0.0026
70920781|NCT02677896|141332307|SUPERIORITY||Cox hazard ratio|0.28|||<|0.0001|TWO_SIDED|95.0|0.22|0.36|||Log Rank|||Time to Castration Resistance Treatment Comparison||0.36|0.22|<0.0001
70973641|NCT01077973|141454027|SUPERIORITY_OR_OTHER||LS mean difference|-0.14||||0.287|TWO_SIDED|95.0|-0.41|0.12||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.12|-0.41|0.287
70973642|NCT01077973|141454028|SUPERIORITY_OR_OTHER||LS mean difference|-0.3||||0.377|TWO_SIDED|95.0|-0.98|0.37||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.37|-0.98|0.377
71032591|NCT02242201|141574446|SUPERIORITY|||||||0.662|||||||Wilcoxon (Mann-Whitney)|||||||0.662
70920782|NCT02677896|141332308|SUPERIORITY||Cox hazard ratio|0.96||||0.6548|TWO_SIDED|95.0|0.81|1.14|||Log Rank|||Time to Deterioration of QoL in FACT-P Treatment Comparison||1.14|0.81|0.6548
70920783|NCT02677896|141332309|SUPERIORITY||Cox hazard ratio|0.92||||0.2715|TWO_SIDED|95.0|0.78|1.07|||Log Rank|||Time to Pain Progression Based on BPI-SF Treatment Comparison||1.07|0.78|0.2715
70920784|NCT02692417|141332354|OTHER|||||||0.109|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test comparing FSFI score from baseline to time point.||||0.109
70920785|NCT02692417|141332354|OTHER|||||||0.225|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test comparing FSFI score from baseline to time point.||||0.225
70920786|NCT02692417|141332355|OTHER|||||||0.109|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test comparing FSFI score from baseline to time point.||||0.109
70920787|NCT02692417|141332355|OTHER|||||||0.046|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test comparing FSFI score from baseline to time point.||||0.046
70920788|NCT02692417|141332356|OTHER|||||||0.109|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test comparing FSFI score from baseline to time point.||||0.109
70920789|NCT02692417|141332356|OTHER|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
70920790|NCT00393484|141332387|NON_INFERIORITY_OR_EQUIVALENCE|The difference in proportion along with its standard error and 90% confidence interval was computed. If the lower limit of the confidence interval (CI) was great than -10%, noninferiority was established. Provided that noninferiority was established, a test for superiority was planned to check that the lower limit of the 90% CI was greater than zero.|Difference in proportion|25.67||||0.0006|TWO_SIDED|90.0|14.48|36.86||There was no adjustment for the prior test of noninferiority because the test for superiority could succeed only if noninferiority was first established.|Chi-squared|||A sample size of 60 per group provides 80% power for testing superiority of entecavir compared to lamivudine, assuming a response rate of 62% for lamivudine and 83% for entecavir.||36.86|14.48|0.0006
70920791|NCT00393484|141332388|SUPERIORITY_OR_OTHER||Difference|24.55||||0.0003|TWO_SIDED|90.0|14.45|34.66||Treatment comparisons were assessed using the same method used in the primary endpoint.|Chi-squared|||HBV DNA \<10\^3 copies/mL at 24 Weeks||34.66|14.45|0.0003
70920792|NCT00393484|141332388|SUPERIORITY_OR_OTHER||Difference|13.62||||0.0167|TWO_SIDED|90.0|4.85|22.38||Treatment comparisons were assessed using the same method as the primary endpoint.|Chi-squared|||HBV DNA \<10\^4 copies/mL at 24 Weeks||22.38|4.85|0.0167
70920793|NCT00393484|141332388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.24||||0.4467|TWO_SIDED|90.0|-2.62|11.1|||Chi-squared|||HBV DNA \<10\^5 at 24 Weeks||11.10|-2.62|0.4467
70920794|NCT00393484|141332388|SUPERIORITY_OR_OTHER||Difference|26.12||||0.0002|TWO_SIDED|90.0|15.87|36.36|||Chi-squared|||HBV DNA \<10\^3 copies/mL at 48 Weeks||36.36|15.87|0.0002
70920795|NCT00393484|141332388|SUPERIORITY_OR_OTHER||Difference|20.09||||0.0009|TWO_SIDED|90.0|11.1|29.07|||Chi-squared|||HBV DNA \<10\^4 copies/mL at 48 Weeks||29.07|11.10|0.0009
70920796|NCT00393484|141332388|SUPERIORITY_OR_OTHER||Difference|16.96||||0.0029|TWO_SIDED|90.0|8.43|25.5|||Chi-squared|||HBV DNA \<10\^5 at 48 Weeks||25.50|8.43|0.0029
70920797|NCT00393484|141332388|SUPERIORITY_OR_OTHER||Difference|35.27|||<|0.0001|TWO_SIDED|90.0|24.02|46.51|||Chi-squared|||HBV DNA \<10\^3 copies/mL at 96 Weeks||46.51|24.02|<0.0001
70920798|NCT00393484|141332388|SUPERIORITY_OR_OTHER||Difference|29.02|||<|0.0001|TWO_SIDED|90.0|18.07|39.97|||Chi-squared|||HBV DNA \<10\^4 copies/mL at 96 Weeks||39.97|18.07|<0.0001
70920799|NCT00393484|141332388|SUPERIORITY_OR_OTHER||Difference|24.33||||0.0006|TWO_SIDED|90.0|13.71|34.95|||Chi-squared|||HBV DNA \<10\^5 copies/mL at 96 Weeks||34.95|13.71|0.0006
71032592|NCT02242201|141574446|SUPERIORITY|||||||0.103|||||||Wilcoxon (Mann-Whitney)|||||||0.103
71032593|NCT02242201|141574447|SUPERIORITY|||||||0.948|||||||Wilcoxon (Mann-Whitney)|||Preoperative||||0.948
71032594|NCT02242201|141574447|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Preoperative||||0.880
71032595|NCT02242201|141574447|SUPERIORITY|||||||0.802|||||||Wilcoxon (Mann-Whitney)|||Preoperative||||0.802
71032596|NCT02242201|141574447|SUPERIORITY|||||||0.179|||||||Wilcoxon (Mann-Whitney)|||Intraoperative||||0.179
71032597|NCT02242201|141574447|SUPERIORITY|||||||0.837|||||||Wilcoxon (Mann-Whitney)|||Intraoperative||||0.837
71154106|NCT03069352|141800768|OTHER||LS Mean Difference|-4.923|STANDARD_ERROR_OF_MEAN|2.58|||TWO_SIDED|95.0|-10.03|0.19|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 5 Day 1||0.19|-10.03|
71032598|NCT02242201|141574447|SUPERIORITY|||||||0.142|||||||Wilcoxon (Mann-Whitney)|||Intraoperative||||0.142
71032599|NCT02242201|141574447|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||PACU||||0.010
71032600|NCT02242201|141574447|SUPERIORITY|||||||0.516|||||||Wilcoxon (Mann-Whitney)|||PACU||||0.516
71032601|NCT02242201|141574447|SUPERIORITY|||||||0.052|||||||Wilcoxon (Mann-Whitney)|||PACU||||0.052
71032602|NCT02242201|141574447|SUPERIORITY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||POD 0 post PACU||||0.840
71032603|NCT02242201|141574447|SUPERIORITY|||||||0.744|||||||Wilcoxon (Mann-Whitney)|||POD 0 post PACU||||0.744
71032604|NCT02242201|141574447|SUPERIORITY|||||||0.501|||||||Wilcoxon (Mann-Whitney)|||POD 0 post PACU||||0.501
71032605|NCT02242201|141574447|SUPERIORITY|||||||0.358|||||||Wilcoxon (Mann-Whitney)|||POD 1||||0.358
71032606|NCT02242201|141574447|SUPERIORITY|||||||0.536|||||||Wilcoxon (Mann-Whitney)|||POD 1||||0.536
71032607|NCT02242201|141574447|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||POD 1||||0.110
71032608|NCT02242201|141574447|SUPERIORITY|||||||0.313|||||||Wilcoxon (Mann-Whitney)|||POD 2||||0.313
71032609|NCT02242201|141574447|SUPERIORITY|||||||0.893|||||||Wilcoxon (Mann-Whitney)|||POD 2||||0.893
71032610|NCT02242201|141574447|SUPERIORITY|||||||0.232|||||||Wilcoxon (Mann-Whitney)|||POD 2||||0.232
70973643|NCT01077973|141454028|SUPERIORITY_OR_OTHER||LS mean difference|-0.34||||0.324|TWO_SIDED|95.0|-1.01|0.34||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.34|-1.01|0.324
70973644|NCT01077973|141454028|SUPERIORITY_OR_OTHER||LS mean difference|0.03||||0.902|TWO_SIDED|95.0|-0.52|0.59||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.59|-0.52|0.902
70973645|NCT01077973|141454028|SUPERIORITY_OR_OTHER||LS mean difference|-0.42||||0.273|TWO_SIDED|95.0|-1.17|0.33||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.33|-1.17|0.273
70973646|NCT01077973|141454028|SUPERIORITY_OR_OTHER||LS mean difference|-0.19||||0.616|TWO_SIDED|95.0|-0.94|0.56||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.56|-0.94|0.616
70973647|NCT01077973|141454028|SUPERIORITY_OR_OTHER||LS mean difference|-0.23||||0.471|TWO_SIDED|95.0|-0.85|0.39||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.39|-0.85|0.471
70973648|NCT01077973|141454028|SUPERIORITY_OR_OTHER||LS mean difference|-0.4||||0.356|TWO_SIDED|95.0|-1.24|0.45||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.45|-1.24|0.356
70973649|NCT01077973|141454028|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.722|TWO_SIDED|95.0|-1.0|0.69||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.69|-1.00|0.722
71032611|NCT02242201|141574448|SUPERIORITY|||||||0.772|||||||Kruskal-Wallis|||||||0.772
71032612|NCT02242201|141574449|SUPERIORITY|||||||0.251|||||||Regression, Cox|||Baseline||||0.251
71032613|NCT02242201|141574449|SUPERIORITY|||||||0.3|||||||Regression, Cox|||3 month follow-up||||0.300
71032614|NCT02242201|141574449|SUPERIORITY|||||||0.113|||||||Regression, Cox|||Baseline vs 3 months||||0.113
71032615|NCT02242201|141574449|SUPERIORITY|||||||0.147|||||||Regression, Cox|||Baseline vs 3 months||||0.147
71032616|NCT02242201|141574449|SUPERIORITY|||||||0.216|||||||Regression, Cox|||Baseline vs 3 months||||0.216
71032617|NCT02242201|141574449|SUPERIORITY|||||||0.968|||||||Regression, Cox|||Baseline vs 3 months||||0.968
71032618|NCT02242201|141574450|SUPERIORITY|||||||0.776|||||||Kruskal-Wallis|||Pain at rest||||0.776
71032619|NCT02242201|141574450|SUPERIORITY|||||||0.447|||||||Kruskal-Wallis|||Pain with movement||||0.447
71032620|NCT02242201|141574451|SUPERIORITY|||||||0.986|||||||ANOVA|||||||0.986
71032621|NCT02242201|141574451|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Baseline vs 3 months||||<0.001
71032622|NCT02242201|141574451|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Baseline vs 3 months||||<0.001
71032623|NCT02242201|141574451|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Baseline vs 3 months||||<0.001
71032624|NCT02242201|141574452|SUPERIORITY|||||||0.898|||||||ANOVA|||||||0.898
71032625|NCT02242201|141574452|SUPERIORITY|||||||0.112|||||||t-test, 1 sided|||Baseline vs 3 months||||0.112
71032626|NCT02242201|141574452|SUPERIORITY|||||||0.046|||||||t-test, 1 sided|||Baseline vs 3 months||||0.046
71032627|NCT02242201|141574452|SUPERIORITY|||||||0.026|||||||t-test, 1 sided|||Baseline vs 3 months||||0.026
71154107|NCT03069352|141800768|OTHER||LS Mean Difference|-0.807|STANDARD_ERROR_OF_MEAN|2.609|||TWO_SIDED|95.0|-5.98|4.36|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 7 Day 1||4.36|-5.98|
71032628|NCT02242201|141574453|SUPERIORITY|||||||0.843|||||||Fisher Exact|||Operative extremity neurologic changes||||0.843
71032629|NCT02242201|141574453|SUPERIORITY|||||||1|||||||Fisher Exact|||Wound infection||||1.00
71032630|NCT02242201|141574453|SUPERIORITY|||||||1|||||||Fisher Exact|||Fall requiring medical attention||||1.00
71032631|NCT02242201|141574454|SUPERIORITY|||||||1|||||||Fisher Exact|||Pain at rest||||1.00
71032632|NCT02242201|141574454|SUPERIORITY|||||||0.167|||||||Fisher Exact|||Pain with movement||||0.167
71032633|NCT00017953|141574455|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.51|TWO_SIDED|95.0|0.83|1.09|||Regression, Cox|||||1.09|0.83|0.51
71032634|NCT00017953|141574456|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.42|TWO_SIDED|95.0|0.79|1.1|||Regression, Cox|||||1.10|0.79|0.42
71032635|NCT00017953|141574457|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.23|TWO_SIDED|95.0|0.82|1.05|||Regression, Cox|||||1.05|0.82|0.23
71032636|NCT00017953|141574458|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.29|TWO_SIDED|95.0|0.84|1.05|||Regression, Cox|||||1.05|0.84|0.29
71094914|NCT01177410|141697945|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.267||||0.6059|TWO_SIDED|95.0|0.515|3.115|||Regression, Logistic|||||3.115|0.515|0.6059
71094915|NCT01177410|141697946|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.232||||0.0327|TWO_SIDED|95.0|1.068|4.664|||Proportional Odds Model|||Proportional odds model was used to compare the number of months the subjects are responders.||4.664|1.068|0.0327
71094916|NCT01177410|141697946|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.148||||0.726|TWO_SIDED|95.0|0.531|2.483|||Proportional Odds Model|||||2.483|0.531|0.7260
71032637|NCT02374853|141574459|SUPERIORITY|||||||0.23|||||||Fisher Exact|||||||0.23
71032638|NCT02374853|141574460|SUPERIORITY|||||||0.25|||||||Fisher Exact|||||||0.25
71032639|NCT02374853|141574461|SUPERIORITY|||||||0.054|||||||Wilcoxon (Mann-Whitney)|||||||.054
71032640|NCT01424644|141574499|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to diphtheria toxin for the MenACWY-CRM+Tdap+HPV group was considered non-inferior to that of the Placebo+Tdap+HPV group if the lower limit of the two-sided 95% CI of the difference in seroprotection rates \[(MenACWY-CRM+Tdap+HPV) minus (Placebo+Tdap + HPV)\] was greater than -10%, at 1 month after Tdap vaccination|Vaccine group difference|13.0|||||TWO_SIDED|95.0|9.0|17.0|||Miettinen and Nurminen|||Non-inferiority of anti-diphtheria immune response following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo||17|9|
71032641|NCT01424644|141574499|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to tetanus toxin for the MenACWY-CRM+Tdap+HPV group was considered non-inferior to that of Placebo+Tdap+HPV group if the lower limit of the two-sided 95% CI of the difference in seroprotection rates \[(MenACWY-CRM+ Tdap+HPV) minus (Placebo+Tdap + HPV)\] was greater than -10%, at 1 month after Tdap vaccination.|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|||Non-inferiority of anti-tetanus immune response following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo.||2|-2|
71094917|NCT01692756|141697988|SUPERIORITY|||||||0.33|||||||Kruskal-Wallis|||||||0.33
71094918|NCT01692756|141697989|SUPERIORITY|||||||0.08|||||||Kruskal-Wallis|||||||0.08
71032642|NCT01424644|141574500|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to PT antigen for the MenACWY-CRM+Tdap+HPV group was considered non-inferior to that of the Placebo+Tdap+HPV group if the lower limit of the two-sided 95% CI of the ratio of the GMCs of the MenACWY-CRM +Tdap+HPV group to the Placebo+Tdap + HPV group was greater than 0.5, at 1 month after Tdap vaccination.|Vaccine group ratio-Geometric mean conc|1.01|||||TWO_SIDED|95.0|0.89|1.14|||ANOVA|||Non-inferiority of anti-PT immune response following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo.||1.14|0.89|
71032643|NCT01424644|141574500|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to FHA antigen for the MenACWY-CRM+Tdap+HPV group was considered non-inferior to that of Placebo+Tdap+HPV group if the lower limit of the 95% CI of the difference \[(MenACWY-CRM +Tdap+HPV) minus(Placebo+Tdap + HPV)\] was greater than 0.5, at 1 month after Tdap vaccination.|Vaccine group ratio- Geometric mean conc|0.84|||||TWO_SIDED|95.0|0.76|0.93|||ANOVA|||Non-inferiority of anti-FHA immune response following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo.||0.93|0.76|
71032644|NCT01424644|141574500|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to PRN antigen for the MenACWY-CRM+Tdap+HPV group was considered non-inferior to that of Placebo+Tdap+HPV group if the lower limit of the 95% CI of the difference \[(MenACWY-CRM+Tdap+HPV) minus(Placebo+Tdap + HPV)\] was greater than 0.5, at 1 month after vaccination.|Vaccine group ratio-Geometric mean conc|0.82|||||TWO_SIDED|95.0|0.72|0.93|||ANOVA|||Non-inferiority of anti-PRN immune response following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo.||0.93|0.72|
71032645|NCT01077596|141574506|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.2||||||95.0|1.1|1.3||||||||1.3|1.1|
71094919|NCT01692756|141697990|SUPERIORITY|||||||0.93|||||||Kruskal-Wallis|||||||0.93
71094920|NCT01692756|141697991|SUPERIORITY|||||||0.13|||||||Kruskal-Wallis|||||||0.13
71094921|NCT01692756|141697992|SUPERIORITY|||||||0.15|||||||Kruskal-Wallis|||||||0.15
71094922|NCT01692756|141697993|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||.003
71094923|NCT01692756|141697994|SUPERIORITY|||||||0.007|||||||Kruskal-Wallis|||||||.007
71094924|NCT01692756|141697995|SUPERIORITY|||||||0.63|||||||Kruskal-Wallis|||||||.63
71094925|NCT01692756|141697996|SUPERIORITY|||||||0.17|||||||Kruskal-Wallis|||||||0.17
71094926|NCT01692756|141697997|SUPERIORITY|||||||0.62|||||||Kruskal-Wallis|||||||.62
71094927|NCT01692756|141697998|SUPERIORITY|||||||0.02|||||||Kruskal-Wallis|||||||.02
71094928|NCT01692756|141697999|SUPERIORITY|||||||0.2|||||||Kruskal-Wallis|||||||.20
71094929|NCT01692756|141698000|SUPERIORITY|||||||0.87|||||||Kruskal-Wallis|||||||.87
71094930|NCT02969018|141698001|OTHER||Least Squares Mean Difference|-8.64|STANDARD_ERROR_OF_MEAN|2.232||0.0005|TWO_SIDED|90.0|-12.33|-4.95||Hochberg adjusted p-value|Mixed Models Analysis|||||-4.95|-12.33|0.0005
71094931|NCT02969018|141698001|OTHER||Least Squares Mean Difference|-3.34|STANDARD_ERROR_OF_MEAN|2.206||0.0963|TWO_SIDED|90.0|-6.99|0.3||Hochberg adjusted p-value|Mixed Models Analysis|||||0.30|-6.99|0.0963
71094932|NCT02969018|141698001|OTHER||Least Squares Mean Difference|-7.07|STANDARD_ERROR_OF_MEAN|2.233||0.0046|TWO_SIDED|90.0|-10.76|-3.37||Hochberg adjusted p-value|Mixed Models Analysis|||||-3.37|-10.76|0.0046
71094933|NCT02969018|141698001|OTHER||Least Squares Mean Difference|-2.93|STANDARD_ERROR_OF_MEAN|2.238||0.0963|TWO_SIDED|90.0|-6.63|0.77||Hochberg adjusted p-value|Mixed Models Analysis|||||0.77|-6.63|0.0963
71032646|NCT01077596|141574506|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|1.0|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.2|1.0|
71032647|NCT01077596|141574506|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.2||||||95.0|1.1|1.3||||||||1.3|1.1|
71032648|NCT01077596|141574506|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|1.0|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.2|1.0|
71032649|NCT01077596|141574506|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.2||||||95.0|1.0|1.3||||||||1.3|1.0|
71032650|NCT01077596|141574506|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|1.0|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.2|1.0|
71032651|NCT01077596|141574506|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.2||||||95.0|1.1|1.4||||||||1.4|1.1|
71032652|NCT01077596|141574506|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.2||||||95.0|1.0|1.3|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.3|1.0|
71032653|NCT01077596|141574507|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.4||||||95.0|0.9|2.2||||||||2.2|0.9|
71032654|NCT01077596|141574507|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.2||||||95.0|0.8|2.0|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||2.0|0.8|
71032655|NCT01077596|141574507|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.2||||||95.0|0.8|2.0||||||||2.0|0.8|
71154108|NCT03069352|141800768|OTHER||LS Mean Difference|-1.648|STANDARD_ERROR_OF_MEAN|3.176|||TWO_SIDED|95.0|-7.94|4.64|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 9 day 1||4.64|-7.94|
71032656|NCT01077596|141574507|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|0.7|1.9|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.9|0.7|
71032657|NCT01077596|141574507|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.3||||||95.0|0.8|2.1||||||||2.1|0.8|
71032658|NCT01077596|141574507|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|0.7|1.9|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.9|0.7|
71032659|NCT01077596|141574507|SUPERIORITY_OR_OTHER||Crude Odds Ratio|2.2||||||95.0|1.2|3.9||||||||3.9|1.2|
71032660|NCT01077596|141574507|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.0||||||95.0|1.1|3.6|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||3.6|1.1|
71032661|NCT01077596|141574508|SUPERIORITY_OR_OTHER||Crude Odds Ratio|4.5||||||95.0|3.2|6.3||||||||6.3|3.2|
71032662|NCT01077596|141574508|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|3.0||||||95.0|2.0|4.4|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||4.4|2.0|
71032663|NCT01077596|141574508|SUPERIORITY_OR_OTHER||Crude Odds Ratio|4.0||||||95.0|2.8|5.8||||||||5.8|2.8|
71032664|NCT01077596|141574508|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.9||||||95.0|1.9|4.5|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||4.5|1.9|
71032665|NCT01077596|141574508|SUPERIORITY_OR_OTHER||Crude Odds Ratio|4.4||||||95.0|3.1|6.3||||||||6.3|3.1|
71032666|NCT01077596|141574508|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|3.0||||||95.0|1.9|4.5|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||4.5|1.9|
71032667|NCT01077596|141574508|SUPERIORITY_OR_OTHER||Crude Odds Ratio|4.5||||||95.0|2.8|7.2||||||||7.2|2.8|
71032668|NCT01077596|141574508|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|3.5||||||95.0|2.1|5.9|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||5.9|2.1|
71032669|NCT01077596|141574509|SUPERIORITY_OR_OTHER||Crude Odds Ratio|2.6||||||95.0|1.7|4.1||||||||4.1|1.7|
71032670|NCT01077596|141574509|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.1||||||95.0|1.3|3.4|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||3.4|1.3|
71032671|NCT01077596|141574509|SUPERIORITY_OR_OTHER||Crude Odds Ratio|2.3||||||95.0|1.4|3.6||||||||3.6|1.4|
71032672|NCT01077596|141574509|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.8||||||95.0|1.1|3.0|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||3.0|1.1|
71032673|NCT01077596|141574509|SUPERIORITY_OR_OTHER||Crude Odds Ratio|2.3||||||95.0|1.5|3.7||||||||3.7|1.5|
71032674|NCT01077596|141574509|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.8||||||95.0|1.1|3.0|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||3.0|1.1|
71032675|NCT01077596|141574509|SUPERIORITY_OR_OTHER||Crude Odds Ratio|2.6||||||95.0|1.5|4.5||||||||4.5|1.5|
71094934|NCT02969018|141698001|OTHER||Least Squares Mean Difference|-10.07|STANDARD_ERROR_OF_MEAN|2.152|<|0.0001|TWO_SIDED|90.0|-13.63|-6.51||Hochberg adjusted p-value|Mixed Models Analysis|||||-6.51|-13.63|<0.0001
70973650|NCT01077973|141454028|SUPERIORITY_OR_OTHER||LS mean difference|-0.24||||0.493|TWO_SIDED|95.0|-0.94|0.46||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.46|-0.94|0.493
70973651|NCT01077973|141454029|SUPERIORITY_OR_OTHER||LS mean difference|-0.27||||0.259|TWO_SIDED|95.0|-0.75|0.2||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.20|-0.75|0.259
70973652|NCT01077973|141454029|SUPERIORITY_OR_OTHER||LS mean difference|-0.21||||0.378|TWO_SIDED|95.0|-0.69|0.26||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.26|-0.69|0.378
70973653|NCT01077973|141454029|SUPERIORITY_OR_OTHER||LS mean difference|-0.06||||0.762|TWO_SIDED|95.0|-0.45|0.33||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.33|-0.45|0.762
70973654|NCT01077973|141454029|SUPERIORITY_OR_OTHER||LS mean difference|-0.42||||0.281|TWO_SIDED|95.0|-1.17|0.34||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.34|-1.17|0.281
70973655|NCT01077973|141454029|SUPERIORITY_OR_OTHER||LS mean difference|-0.21||||0.582|TWO_SIDED|95.0|-0.97|0.55||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.55|-0.97|0.582
70973656|NCT01077973|141454029|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.523|TWO_SIDED|95.0|-0.83|0.42||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.42|-0.83|0.523
70973657|NCT01077973|141454030|SUPERIORITY_OR_OTHER||LS mean difference|-0.45||||0.327|TWO_SIDED|95.0|-1.35|0.45||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.45|-1.35|0.327
70973658|NCT01077973|141454030|SUPERIORITY_OR_OTHER||LS mean difference|-0.32||||0.489|TWO_SIDED|95.0|-1.21|0.58||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.58|-1.21|0.489
70973659|NCT01077973|141454030|SUPERIORITY_OR_OTHER||LS mean difference|-0.13||||0.726|TWO_SIDED|95.0|-0.88|0.61||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.61|-0.88|0.726
71032676|NCT01077596|141574509|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.2||||||95.0|1.3|3.9|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||3.9|1.3|
70973660|NCT01077973|141454030|SUPERIORITY_OR_OTHER||LS mean difference|-0.7||||0.32|TWO_SIDED|95.0|-2.09|0.69||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.69|-2.09|0.320
70973661|NCT01077973|141454030|SUPERIORITY_OR_OTHER||LS mean difference|-0.47||||0.506|TWO_SIDED|95.0|-1.86|0.92||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.92|-1.86|0.506
70973662|NCT01077973|141454030|SUPERIORITY_OR_OTHER||LS mean difference|-0.23||||0.691|TWO_SIDED|95.0|-1.38|0.92||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.92|-1.38|0.691
71032677|NCT01077596|141574510|SUPERIORITY_OR_OTHER||Crude Odds Ratio|0.8||||||95.0|0.5|1.3||||||||1.3|0.5|
70973663|NCT01077973|141454031|SUPERIORITY_OR_OTHER||LS mean difference|-0.72||||0.292|TWO_SIDED|95.0|-2.07|0.62||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.62|-2.07|0.292
71032678|NCT01077596|141574510|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.7||||||95.0|0.4|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.2|0.4|
71154109|NCT03069352|141800768|SUPERIORITY|||||||0.126|||||||Linear Mixed Effects Regression Model|Model included AML status (de novo vs. secondary), age (18-\< 75 vs. ≥ 75), treatment arm, time, and treatment arm by time interaction as fixed factors||A linear mixed effects regression model with a variable covariance structure was fitted to the longitudinal data (considering all time points) to test for differences between treatment arms.||||0.126
70973664|NCT01077973|141454031|SUPERIORITY_OR_OTHER||LS mean difference|-0.53||||0.439|TWO_SIDED|95.0|-1.87|0.82||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.82|-1.87|0.439
70973665|NCT01077973|141454031|SUPERIORITY_OR_OTHER||LS mean difference|-0.19||||0.733|TWO_SIDED|95.0|-1.31|0.92||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.92|-1.31|0.733
70973666|NCT01077973|141454031|SUPERIORITY_OR_OTHER||LS mean difference|-0.68||||0.526|TWO_SIDED|95.0|-2.8|1.43||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.43|-2.80|0.526
70973667|NCT01077973|141454031|SUPERIORITY_OR_OTHER||LS mean difference|-0.44||||0.624|TWO_SIDED|95.0|-2.19|1.31||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.31|-2.19|0.624
70973668|NCT01077973|141454032|SUPERIORITY_OR_OTHER||Difference in proportion|3.02||||0.672|TWO_SIDED|95.0|-11.03|17.07||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions and the corresponding standard error.||17.07|-11.03|0.672
70973669|NCT01077973|141454032|SUPERIORITY_OR_OTHER||Difference in proportion|-4.47||||0.467|TWO_SIDED|95.0|-17.61|8.68||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.68|-17.61|0.467
70973670|NCT01077973|141454032|SUPERIORITY_OR_OTHER||Difference in proportion|7.55||||0.164|TWO_SIDED|95.0|-2.96|18.05||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.05|-2.96|0.164
70973671|NCT01077973|141454032|SUPERIORITY_OR_OTHER||Difference in proportion|-7.52||||0.427|TWO_SIDED|95.0|-25.96|10.92||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.92|-25.96|0.427
70973672|NCT01077973|141454032|SUPERIORITY_OR_OTHER||Difference in proportion|-5.66||||0.537|TWO_SIDED|95.0|-23.57|12.25||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.25|-23.57|0.537
70973673|NCT01077973|141454032|SUPERIORITY_OR_OTHER||Difference in proportion|-1.83||||0.813|TWO_SIDED|95.0|-16.88|13.22||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.22|-16.88|0.813
70973674|NCT01077973|141454032|SUPERIORITY_OR_OTHER||Difference in proportion|-5.5||||0.455|TWO_SIDED|95.0|-19.24|8.24||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.24|-19.24|0.455
71032679|NCT01077596|141574510|SUPERIORITY_OR_OTHER||Crude Odds Ratio|0.6||||||95.0|0.4|1.1||||||||1.1|0.4|
71032680|NCT01077596|141574510|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.6||||||95.0|0.3|1.0|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.0|0.3|
71032681|NCT01077596|141574510|SUPERIORITY_OR_OTHER||Crude Odds Ratio|0.8||||||95.0|0.5|1.4||||||||1.4|0.5|
71032682|NCT01077596|141574510|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.8||||||95.0|0.4|1.4|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.4|0.4|
71032683|NCT01077596|141574510|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.1||||||95.0|0.6|2.0||||||||2.0|0.6|
71032684|NCT01077596|141574510|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.0||||||95.0|0.6|1.9|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status†, previous depression dx, previous IBD‡ diagnosis, OC§ use, HRT/ERT use, and NSAID use.|||1.9|0.6|
71032685|NCT01077596|141574511|SUPERIORITY_OR_OTHER||Crude Odds Ratio|0.9||||||95.0|0.8|1.1||||||||1.1|0.8|
71094935|NCT02969018|141698001|OTHER||Least Squares Mean Difference|-6.06|STANDARD_ERROR_OF_MEAN|2.255||0.0158|TWO_SIDED|90.0|-9.79|-2.33||Hochberg adjusted p-value|Mixed Models Analysis|||||-2.33|-9.79|0.0158
71094936|NCT02969018|141698001|OTHER||Least Squares Mean Difference|-4.66|STANDARD_ERROR_OF_MEAN|2.163||0.0488|TWO_SIDED|90.0|-8.24|-1.09||Hochberg adjusted p-value|Mixed Models Analysis|||||-1.09|-8.24|0.0488
71094937|NCT02969018|141698002|OTHER||Odds Ratio (OR)|10.0|||||TWO_SIDED|90.0|2.95|33.87|||||||Logistic regression|33.87|2.95|
71094938|NCT02969018|141698002|OTHER||Odds Ratio (OR)|2.12|||||TWO_SIDED|90.0|0.61|7.36|||||||Logistic regression|7.36|0.61|
71094939|NCT02969018|141698002|OTHER||Odds Ratio (OR)|9.09|||||TWO_SIDED|90.0|2.71|30.48|||||||Logistic regression|30.48|2.71|
71094940|NCT02969018|141698002|OTHER||Odds Ratio (OR)|2.11|||||TWO_SIDED|90.0|0.59|7.55|||||||Logistic regression|7.55|0.59|
71094941|NCT02969018|141698002|OTHER||Odds Ratio (OR)|41.67|||||TWO_SIDED|90.0|10.8|160.68|||||||Logistic regression|160.68|10.80|
71094942|NCT02969018|141698002|OTHER||Odds Ratio (OR)|2.11|||||TWO_SIDED|90.0|0.59|7.55|||||||Logistic regression|7.55|0.59|
71094943|NCT02969018|141698002|OTHER||Odds Ratio (OR)|3.86|||||TWO_SIDED|90.0|1.17|12.74|||||||Logistic regression|12.74|1.17|
71094944|NCT02969018|141698003|OTHER||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.47|<|0.0001|TWO_SIDED|90.0|-11.43|-6.57|||Mixed Models Analysis|||||-6.57|-11.43|<0.0001
71094945|NCT02969018|141698003|OTHER||Least Squares Mean Difference|-7.99|STANDARD_ERROR_OF_MEAN|1.502|<|0.0001|TWO_SIDED|90.0|-10.48|-5.51|||Mixed Models Analysis|||||-5.51|-10.48|<0.0001
71094946|NCT04018001|141698021|SUPERIORITY|||||||0.0115|||||||Chi-squared|||||||0.0115
71032686|NCT01077596|141574511|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.9||||||95.0|0.8|1.1|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.1|0.8|
71032687|NCT01077596|141574511|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.0||||||95.0|0.9|1.2||||||||1.2|0.9|
71032688|NCT01077596|141574511|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.0||||||95.0|0.8|1.1|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.1|0.8|
71032689|NCT01077596|141574511|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.0||||||95.0|0.8|1.1||||||||1.1|0.8|
71032690|NCT01077596|141574511|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.9||||||95.0|0.8|1.1|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.1|0.8|
71032691|NCT01077596|141574511|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.1||||||95.0|0.9|1.3||||||||1.3|0.9|
71032692|NCT01077596|141574511|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|0.9|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.2|0.9|
71032693|NCT01077596|141574512|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.1||||||95.0|1.0|1.3||||||||1.3|1.0|
71032694|NCT01077596|141574512|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.2||||||95.0|1.0|1.3|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.3|1.0|
71032695|NCT01077596|141574512|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.2||||||95.0|1.0|1.4||||||||1.4|1.0|
71032696|NCT01077596|141574512|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.2||||||95.0|1.0|1.4|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.4|1.0|
71032697|NCT01077596|141574512|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.1||||||95.0|0.9|1.2||||||||1.2|0.9|
71032698|NCT01077596|141574512|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|0.9|1.3|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.3|0.9|
71032699|NCT01077596|141574512|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.0||||||95.0|0.9|1.2||||||||1.2|0.9|
71032700|NCT01077596|141574512|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.0||||||95.0|0.8|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.2|0.8|
71032701|NCT02024932|141574527|SUPERIORITY_OR_OTHER_LEGACY||Geo-mean ratio|1.037||||0.0164|TWO_SIDED|90.0|1.009|1.065|||ANCOVA|||||1.065|1.009|0.0164
71032702|NCT03020641|141574564|OTHER|t-test|Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.2347||0.058|TWO_SIDED|95.0||0.1276||the threshold for statistical significance was p\<=0.05.|t-test, 2 sided|||Interleukin 1 (IL1)||0.1276|- 0.8077|0.058
71032703|NCT03020641|141574564|OTHER|Interleukin 6 (IL6)|Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.29||0.001|TWO_SIDED|95.0|-1.6|-0.44|||t-test, 2 sided|||||-0.44|-1.60|0.001
71032704|NCT03020641|141574564|OTHER||Mean Difference (Net)|0.34|STANDARD_ERROR_OF_MEAN|0.211||0.052|TWO_SIDED|95.0|-0.76|0.81|||t-test, 2 sided|||Interleukin 10||0.81|-0.76|0.052
71094947|NCT04018001|141698021|SUPERIORITY||Odds Ratio (OR)|1.410198||||0.0227|TWO_SIDED|95.0|1.0492535|1.8953079||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Logistic|||||1.8953079|1.0492535|0.0227
71094948|NCT04018001|141698022|SUPERIORITY|||||||0.3564|||||||t-test, 2 sided|||||||0.3564
71094949|NCT04018001|141698022|SUPERIORITY||Hazard Ratio (HR)|0.9022||||0.2629|TWO_SIDED|95.0|0.7534|1.0803||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Cox|||||1.0803|0.7534|0.2629
71094950|NCT04018001|141698023|SUPERIORITY|||||||0.0123|||||||t-test, 2 sided|||||||0.0123
71094951|NCT04018001|141698023|SUPERIORITY||Difference in Least Squares (LS) Means|0.0300853||||0.0047|TWO_SIDED|95.0|0.0092322|0.0509385||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Generalized linear model|||||0.0509385|0.0092322|0.0047
71094952|NCT04018001|141698024|SUPERIORITY|||||||0.0002|||||||Chi-squared|||||||0.0002
71032705|NCT03020641|141574564|OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.181||0.815|TWO_SIDED|95.0|-0.5|0.22|||t-test, 2 sided|||Vascular Endotelial Grow Factor A||0.22|-0.50|0.815
70973675|NCT01077973|141454032|SUPERIORITY_OR_OTHER||Difference in proportion|-4.02||||0.57|TWO_SIDED|95.0|-17.63|9.59||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.59|-17.63|0.570
70973676|NCT01077973|141454032|SUPERIORITY_OR_OTHER||Difference in proportion|-1.65||||0.792|TWO_SIDED|95.0|-13.8|10.5||p-value was calculated using CMH test which was adjusted which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.50|-13.80|0.792
70973677|NCT01077973|141454032|SUPERIORITY_OR_OTHER||Difference in proportion|-4.25||||0.556|TWO_SIDED|95.0|-17.82|9.33||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.33|-17.82|0.556
70973678|NCT01077973|141454032|SUPERIORITY_OR_OTHER||Difference in proportion|-2.77||||0.689|TWO_SIDED|95.0|-16.24|10.69||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.69|-16.24|0.689
70973679|NCT01077973|141454032|SUPERIORITY_OR_OTHER||Difference in proportion|-1.65||||0.786|TWO_SIDED|95.0|-13.45|10.14||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.14|-13.45|0.786
70973680|NCT01077973|141454033|SUPERIORITY_OR_OTHER||Difference in proportion|6.06||||0.48|TWO_SIDED|95.0|-10.86|22.99||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||22.99|-10.86|0.480
70973681|NCT01077973|141454033|SUPERIORITY_OR_OTHER||Difference in proportion|4.34||||0.612|TWO_SIDED|95.0|-12.55|21.23||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||21.23|-12.55|0.612
70973682|NCT01077973|141454033|SUPERIORITY_OR_OTHER||Difference in proportion|1.47||||0.839|TWO_SIDED|95.0|-12.6|15.55||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.55|-12.60|0.839
70973683|NCT01077973|141454033|SUPERIORITY_OR_OTHER||Difference in proportion|-13.2||||0.13|TWO_SIDED|95.0|-29.4|2.99||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.99|-29.40|0.130
71032706|NCT03020641|141574564|OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.19||0.742|TWO_SIDED|95.0|-0.42|0.36|||t-test, 2 sided|||TNF alfa||0.36|-0.42|0.742
71032707|NCT03020641|141574564|OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.2||0.603|TWO_SIDED|95.0|-0.36|0.44|||t-test, 2 sided|||Chemokine CXC ligand 2||0.44|-0.36|0.603
71032708|NCT03020641|141574565|OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.28||0.6|TWO_SIDED|95.0|-0.47|0.65|||t-test, 2 sided|||Matrix metalloproteinase-9||0.65|-0.47|0.600
71032709|NCT03020641|141574565|OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.24||0.028|TWO_SIDED|95.0|0.03|0.97|||t-test, 2 sided|||Plasminogen activator inhibitor-1||0.97|0.030|0.028
71094953|NCT04018001|141698024|SUPERIORITY||Odds Ratio (OR)|1.7910474||||0.0002|TWO_SIDED|95.0|1.3167136|2.4362554||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Logistic|||||2.4362554|1.3167136|0.0002
71032710|NCT03020641|141574565|OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.36||0.807|TWO_SIDED|95.0|-0.64|0.82|||t-test, 2 sided|||E-selectin||0.82|-0.64|0.807
71032711|NCT03020641|141574567|OTHER||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|4.44||0.862|TWO_SIDED|95.0|-7.49|10.21|||t-test, 2 sided|||||10.21|-7.49|0.862
71032712|NCT00939003|141574601|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71032713|NCT00939003|141574602|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared|||||||0.004
71032714|NCT00939003|141574603|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||||||0.001
71032715|NCT00939003|141574604|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANCOVA|ANCOVA model adjusting for Baseline value with treatment as a factor.||||||0.001
71094954|NCT04018001|141698025|SUPERIORITY|||||||0.4071|||||||t-test, 2 sided|||||||0.4071
71094955|NCT04018001|141698025|SUPERIORITY||Difference in LS Means|0.0104065||||0.6143|TWO_SIDED|95.0|-0.030062|0.0508746||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Generalized linear model|||||0.0508746|-0.030062|0.6143
71094956|NCT04018001|141698026|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.0010
71032716|NCT00939003|141574605|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Chi-squared|||||||0.014
71032717|NCT00939003|141574608|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
70920800|NCT00393484|141332389|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariates of treatment and baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from baseline were based on patients with measurements at both Baseline and Week 24.||||<0.0001
70920801|NCT00393484|141332389|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariants of treatment and Baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from Baseline were based on patients with measurements at both Baseline and at Week 48.||||<0.0001
70920802|NCT00393484|141332389|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariants of treatment and Baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from Baseline were based on patients with measurements at both Baseline and at 96 Weeks.||||<0.0001
70920803|NCT00393484|141332389|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariants of treatment and Baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from Baseline were based on patients with measurements at both Baseline and at Week 144.||||<0.0001
70920804|NCT00393484|141332389|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariants of treatment and Baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from Baseline were based on patients with measurements at both Baseline and at Week 192.||||<0.0001
70920805|NCT00393484|141332389|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariants of treatment and Baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from Baseline were based on patients with measurements at both Baseline and at Week 240.||||<0.0001
70920806|NCT00393484|141332391|SUPERIORITY_OR_OTHER||Difference|18.97||||0.0278|TWO_SIDED|90.0|5.22|32.73|||Chi-squared||At 24 Weeks|||32.73|5.22|0.0278
70920807|NCT00393484|141332391|SUPERIORITY_OR_OTHER||Difference|26.34||||0.0014|TWO_SIDED|90.0|13.65|39.03|||Chi-squared||At 48 Weeks|||39.03|13.65|0.0014
70920808|NCT00393484|141332391|SUPERIORITY_OR_OTHER||Difference|35.94|||<|0.0001|TWO_SIDED|90.0|23.35|48.52|||Chi-squared||At 96 Weeks|||48.52|23.35|<0.0001
70920809|NCT00393484|141332397|SUPERIORITY_OR_OTHER||Difference|33.71|||<|0.0001|TWO_SIDED|90.0|22.52|44.89|||Chi-squared||At 48 Weeks|||44.89|22.52|<0.0001
70920810|NCT00393484|141332397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.21|||<|0.0001|TWO_SIDED|90.0|34.8|57.61|||Chi-squared||At 96 Weeks|||57.61|34.80|<0.0001
70920811|NCT00393484|141332397|SUPERIORITY_OR_OTHER||Difference|33.48||||0.0003|TWO_SIDED|90.0|19.31|47.65|||Chi-squared||At 144 Weeks|||47.65|19.31|0.0003
70920812|NCT00393484|141332397|SUPERIORITY_OR_OTHER||Difference|44.64|||<|0.0001|TWO_SIDED|90.0|31.17|58.11|||Chi-squared||At 192 Weeks|||58.11|31.17|<0.0001
70920813|NCT00393484|141332397|SUPERIORITY_OR_OTHER||Difference|52.23|||<|0.0001|TWO_SIDED|90.0|39.54|64.93|||Chi-squared||At 240 Weeks|||64.93|39.54|<0.0001
70920814|NCT00393484|141332398|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||Viral rebound at 96 weeks||||<0.0001
70920815|NCT03201562|141332401|SUPERIORITY||Odds Ratio (OR)|38.436||||0.0009|TWO_SIDED|90.0|6.262|235.936|||Generalized Estimating Equation (GEE)|GEE model includes 3-line improvement as response variable with sequence, period, treatment as fixed effect, subject within sequence as random effect.||||235.936|6.262|0.0009
71032718|NCT00939003|141574609|SUPERIORITY_OR_OTHER|||||||0.027|||||||ANCOVA|ANCOVA model adjusting for Baseline value with treatment as a factor.||||||0.027
71032719|NCT00939003|141574610|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|ANCOVA model adjusting for Baseline value with treatment as a factor.||||||<0.001
70920816|NCT03201562|141332401|SUPERIORITY||Odds Ratio (OR)|36.893||||0.0012|TWO_SIDED|90.0|5.936|229.31|||Generalized Estimating Equation (GEE)|GEE model includes 3-line improvement as response variable with sequence, period, treatment as fixed effect, subject within sequence as random effect.||||229.310|5.936|0.0012
70920817|NCT03201562|141332401|SUPERIORITY||Odds Ratio (OR)|1.042||||0.9298|TWO_SIDED|90.0|0.485|2.239|||Generalized Estimating Equation (GEE)|GEE model includes 3-line improvement as response variable with sequence, period, treatment as fixed effect, subject within sequence as random effect||||2.239|0.485|0.9298
70920818|NCT00879060|141332405|OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare continuous variable PINP (serum marker of collagen formation/degradation) between spironolactone treated and placebo groups at baseline.||||1.0
70920819|NCT00879060|141332405|OTHER||Mean Difference (Final Values)|0.2||||0.8|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare continuous variable PIIINP (serum marker of collagen formation/degradation) between spironolactone treated and placebo groups at baseline.||||0.8
70920820|NCT00879060|141332405|OTHER||Mean Difference (Final Values)|0.3||||0.3|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.aseline.|t-test, 2 sided|||A two-sample T-test was used to compare continuous variable ICTP (serum marker of collagen formation/degradation) between spironolactone treated and placebo groups at baseline.||||0.3
70920821|NCT00879060|141332405|OTHER||Absolute difference|0.0||||1|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable PINP (serum marker of collagen formation/degradation) between spironolactone treated and placebo groups.||||1.0
70920822|NCT00879060|141332406|OTHER||Absolute difference|1.2||||0.7|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable peak oxygen consumption with exercise (peak VO2) between spironolactone treated and placebo groups.||||0.7
71032720|NCT00939003|141574611|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANCOVA|ANCOVA model adjusting for Baseline value with treatment as a factor.||||||0.003
71032721|NCT00939003|141574612|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANCOVA|ANCOVA model adjusting for Baseline value with treatment as a factor.||||||0.001
71094957|NCT04018001|141698026|SUPERIORITY||Odds Ratio (OR)|1.5211586||||0.0025|TWO_SIDED|95.0|1.1594614|1.9956882||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Logistic|||||1.9956882|1.1594614|0.0025
70973684|NCT01077973|141454033|SUPERIORITY_OR_OTHER||Difference in proportion|-7.83||||0.331|TWO_SIDED|95.0|-23.39|7.73||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||7.73|-23.39|0.331
70973685|NCT01077973|141454033|SUPERIORITY_OR_OTHER||Difference in proportion|-5.5||||0.45|TWO_SIDED|95.0|-19.59|8.59||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.59|-19.59|0.450
70973686|NCT01077973|141454033|SUPERIORITY_OR_OTHER||Difference in proportion|-4.25||||0.556|TWO_SIDED|95.0|-17.82|9.33||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.33|-17.82|0.556
70973687|NCT01077973|141454033|SUPERIORITY_OR_OTHER||Difference in proportion|-2.77||||0.689|TWO_SIDED|95.0|-16.24|10.69||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.69|-16.24|0.689
70973688|NCT01077973|141454033|SUPERIORITY_OR_OTHER||Difference in proportion|-1.65||||0.786|TWO_SIDED|95.0|-13.45|10.14||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.14|-13.45|0.786
70973689|NCT01077973|141454033|SUPERIORITY_OR_OTHER||Difference in proportion|-4.25||||0.556|TWO_SIDED|95.0|-17.82|9.33||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.33|-17.82|0.556
70973690|NCT01077973|141454033|SUPERIORITY_OR_OTHER||Difference in proportion|-2.77||||0.689|TWO_SIDED|95.0|-16.24|10.69||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.69|-16.24|0.689
70973691|NCT01077973|141454033|SUPERIORITY_OR_OTHER||Difference in proportion|-1.65||||0.786|TWO_SIDED|95.0|-13.45|10.14||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.14|-13.45|0.786
70973692|NCT01077973|141454036|SUPERIORITY_OR_OTHER||Difference in proportion|3.89||||0.355|TWO_SIDED|95.0|-3.33|11.1||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.10|-3.33|0.355
70973693|NCT01077973|141454036|SUPERIORITY_OR_OTHER||Difference in proportion|-1.21||||0.623|TWO_SIDED|95.0|-6.62|4.2||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.20|-6.62|0.623
70973694|NCT01077973|141454036|SUPERIORITY_OR_OTHER||Difference in proportion|5.1||||0.094|TWO_SIDED|95.0|-0.9|11.11||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.11|-0.90|0.094
70973695|NCT01077973|141454036|SUPERIORITY_OR_OTHER||Difference in proportion|4.43||||0.565|TWO_SIDED|95.0|-10.43|19.29||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||19.29|-10.43|0.565
70973696|NCT01077973|141454036|SUPERIORITY_OR_OTHER||Difference in proportion|-2.09||||0.765|TWO_SIDED|95.0|-16.15|11.97||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.97|-16.15|0.765
71094958|NCT04018001|141698027|SUPERIORITY|||||||0.4595|||||||t-test, 2 sided|||||||0.4595
71094959|NCT04018001|141698027|SUPERIORITY||Hazard Ratio (HR)|1.1225||||0.3354|TWO_SIDED|95.0|0.8873|1.4201||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Cox|||||1.4201|0.8873|0.3354
71094960|NCT04018001|141698028|SUPERIORITY|||||||0.113|||||||t-test, 2 sided|||||||0.1130
71094961|NCT04018001|141698028|SUPERIORITY||Difference in LS Means|0.0151242||||0.1194|TWO_SIDED|95.0|-0.003908|0.0341568||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Generalized linear model|||||0.0341568|-0.003908|0.1194
70920823|NCT00879060|141332407|OTHER||Absolute difference|0.0||||0.8|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable New York Heart Association (NYHA) Functional Class between spironolactone treated and placebo groups.||||0.8
70920824|NCT00879060|141332408|OTHER||Absolute difference|1.4||||1|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable Septal E/e' between spironolactone treated and placebo groups.||||1.0
70920825|NCT00879060|141332409|OTHER||Absolute difference|0.2||||0.7|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable percentage of left ventricular mass (%LV) between spironolactone treated and placebo groups.||||0.7
70920826|NCT00879060|141332410|OTHER||Absolute difference|0.9||||0.4|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable maximum left ventricular wall thickness (Max LV) between spironolactone treated and placebo groups.||||0.4
70920827|NCT00879060|141332411|OTHER||Absolute difference|5.7||||0.7|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable left ventricular end-diastolic (LVED) cavity size between spironolactone treated and placebo groups.||||0.7
70920828|NCT00879060|141332412|OTHER||Absolute difference|0.1||||0.8|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable left atrial dimension between spironolactone treated and placebo groups.||||0.8
70920829|NCT00957242|141332429|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.32||||0.27|TWO_SIDED|95.0|0.7|2.47|||Regression, Cox|Prespecified covariates in the model included an indicator variable for the treatment group and the DLCO measurement from the baseline assessment.|Warfarin vs. Placebo|The study was designed to have 90% power to detect a difference in 48-week event free rates of 70% for the warfarin group versus 50% for the placebo group. A total of at least 95 adjudicated primary endpoints were required to achieve 90% power with 2-sided, type I error rate of 0.05 and a 1:1 randomization ratio. These calculations yielded a requisite total sample size of 256.||2.47|0.70|0.27
70920830|NCT00957242|141332430|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|5.03||||0.005|TWO_SIDED|95.0|1.44|17.54|||Cox Proportional|||||17.54|1.44|0.005
70920831|NCT00957242|141332431|SUPERIORITY_OR_OTHER||t-value|0.08||||0.083||95.0|-0.01|0.17|||Mixed Models Analysis|||||0.17|-0.01|0.083
70920832|NCT00957242|141332432|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.06||||0.054|TWO_SIDED|95.0|0.99|4.31|||Cox Proportional|||||4.31|0.99|0.054
70920833|NCT00957242|141332433|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.47||||0.19|TWO_SIDED|95.0|0.64|9.56|||Cox Proportional|||||9.56|0.64|0.19
70920834|NCT00957242|141332434|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.25||||0.35|TWO_SIDED|95.0|0.41|12.34|||Cox Proportional|||||12.34|0.41|0.35
70920835|NCT00957242|141332435|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.24||||0.15|TWO_SIDED|95.0|0.65|16.1|||Cox Proportional|||||16.10|0.65|0.15
71094962|NCT04018001|141698029|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||0.0200
70920836|NCT00957242|141332436|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.88|TWO_SIDED|95.0|0.24|3.39|||Cox Proportional|||||3.39|0.24|0.88
70920837|NCT00957242|141332437|SUPERIORITY_OR_OTHER||t-value|10.88||||0.7222|TWO_SIDED|95.0|-49.57|71.34|||Mixed Models Analysis|||||71.34|-49.57|0.7222
70920838|NCT00957242|141332438|SUPERIORITY_OR_OTHER||t-value|-1.78||||0.27|TWO_SIDED|95.0|-7.04|3048.0|||Mixed Models Analysis|||||3048|-7.04|0.27
70920839|NCT00957242|141332439|SUPERIORITY_OR_OTHER||t-value|0.05||||0.957|TWO_SIDED|95.0|-1.67|1076.0|||Mixed Models Analysis|||||1076|-1.67|0.957
70920840|NCT00957242|141332440|SUPERIORITY_OR_OTHER||t-value|-0.48||||0.009|TWO_SIDED|95.0|-0.84|-0.12|||Mixed Models Analysis|||||-0.12|-0.84|0.009
70920841|NCT02539225|141332441|SUPERIORITY|||||||0.698|||||||Stratified Log Rank|||||||0.698
71094963|NCT04018001|141698029|SUPERIORITY||Odds Ratio (OR)|1.4143816||||0.0364|TWO_SIDED|95.0|1.0221455|1.9571335||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Logistic|||||1.9571335|1.0221455|0.0364
71094964|NCT04018001|141698030|SUPERIORITY|||||||0.9031|||||||t-test, 2 sided|||||||0.9031
70920842|NCT02539225|141332442|SUPERIORITY|||||||0.549|||||||Log Rank Stratified|||||||0.549
70920843|NCT02539225|141332443|SUPERIORITY|||||||0.548|||||||Log Rank Stratified|||||||0.548
70920844|NCT02539225|141332444|SUPERIORITY||Odds Ratio (OR)|1.374||||0.402|TWO_SIDED|80.0|0.844|2.236|||Cochran-Mantel-Haenszel|||||2.236|0.844|0.402
70920845|NCT02539225|141332445|SUPERIORITY||Odds Ratio (OR)|1.527||||0.501|TWO_SIDED|80.0|0.68|3.433|||Cochran-Mantel-Haenszel|||||3.433|0.680|0.501
70920846|NCT01976312|141332473|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
70920847|NCT03010631|141332480|SUPERIORITY||Ratio of Geometric LS Means|1.441|||||TWO_SIDED|90.0|1.166|1.782||||||||1.782|1.166|
70920848|NCT03010631|141332481|SUPERIORITY||Ratio of Geometric LS Means|2.045|||||TWO_SIDED|90.0|1.615|2.589||||||||2.589|1.615|
70920849|NCT03010631|141332482|OTHER||Ratio of Geometric LS Means|0.888|||||TWO_SIDED|90.0|0.675|1.168||||||||1.168|0.675|
70920850|NCT03010631|141332483|OTHER||Ratio of Geometric LS Means|0.413|||||TWO_SIDED|90.0|0.339|0.502||||||||0.502|0.339|
70920851|NCT04048382|141332485|SUPERIORITY||Odds Ratio (OR)|1.1||||0.88|TWO_SIDED||||||Regression, Logistic|||||||.88
70920852|NCT04048382|141332486|SUPERIORITY||Odds Ratio (OR)|1.7||||0.49|TWO_SIDED||||||Regression, Logistic|||||||.49
70920853|NCT04048382|141332487|SUPERIORITY||Odds Ratio (OR)|1.1||||0.91|TWO_SIDED||||||Regression, Logistic|||||||.91
71094965|NCT04018001|141698030|SUPERIORITY||Difference in LS Means|-0.008587||||0.6376|TWO_SIDED|95.0|-0.044317|0.0271416||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Generalized linear model|||||0.0271416|-0.044317|0.6376
70920854|NCT04048382|141332488|SUPERIORITY||Odds Ratio (OR)|1.4||||0.65|TWO_SIDED||||||Regression, Logistic|||||||.65
70920855|NCT04048382|141332489|SUPERIORITY||Odds Ratio (OR)|0.29||||0.17|TWO_SIDED||||||Regression, Logistic|||||||.17
70920856|NCT04048382|141332490|SUPERIORITY||Odds Ratio (OR)|0.29||||0.19|TWO_SIDED||||||Regression, Logistic|||||||.19
70920857|NCT01255670|141332512|OTHER|Mann-Whitney U-test and Fisher's exact test||||||0.05|||||||Fisher Exact|||||||0.05
70920858|NCT01255670|141332513|OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U-test and Fisher's exact test||||0.05
70920859|NCT02269475|141332514|SUPERIORITY_OR_OTHER||Vaccine efficacy (%)|100.0|||||TWO_SIDED|95.0|-1875.3|100.0||"No statistical tests were used, instead the confidence interval was used for showing superiority.~If lower bound of the 95% CI is greater than 0%, the efficacy of MEDI3250 is demonstrated."|Exact conditional method|Estimated by an exact conditional method in total number of cases which follows a Poisson assumption.|Vaccine efficacy (%) = (1-RR)\*100 where RR = Risk Reduction.|||100.0|-1875.3|
70920860|NCT02269475|141332515|SUPERIORITY_OR_OTHER||Vaccine efficacy (%)|27.5|||||TWO_SIDED|95.0|7.4|43.0||"No statistical tests were used, instead the confidence interval was used for showing superiority.~If lower bound of the 95% CI is greater than 0%, the efficacy of MEDI3250 is demonstrated."|Exact conditional method|Estimated by an exact conditional method in total number of cases which follows a Poisson assumption.|Vaccine efficacy (%) = (1-RR)\*100 where RR = Risk Reduction.|||43.0|7.4|
70920861|NCT01037985|141332517|SUPERIORITY||Mean Difference (Final Values)|-4.3||||0.168|TWO_SIDED|95.0|-10.4|1.9|||t-test, 2 sided|||Within participant treatment difference was assessed between the treatment regimens each participant received (EXC 001 minus placebo).||1.9|-10.4|0.168
70920862|NCT01037985|141332518|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.858|TWO_SIDED|95.0|-3.5|4.2|||t-test, 2 sided|||Within participant treatment difference was assessed between the treatment regimens each participant received (EXC 001 minus placebo).||4.2|-3.5|0.858
70920863|NCT01037985|141332519|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.003|TWO_SIDED|95.0|-1.6|-0.4|||t-test, 2 sided|||Week 12, Vascularity: Comparison within the participant between EXC 001 and placebo.||-0.4|-1.6|0.003
70920864|NCT01037985|141332519|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.067|TWO_SIDED|95.0|-1.1|0.0|||t-test, 2 sided|||Week 12, Pigmentation: Comparison within the participant between EXC 001 and placebo.||0.0|-1.1|0.067
70920865|NCT01037985|141332519|SUPERIORITY||Mean Difference (Final Values)|-1.4|||<|0.001|TWO_SIDED|95.0|-2.1|-0.7|||t-test, 2 sided|||Week 12, Thickness: Comparison within the participant between EXC 001 and placebo.||-0.7|-2.1|<0.001
71032722|NCT00834418|141574646|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-72 and Cmax.|Geometric Test/Ref Ratio x 100|107.0||||||90.0|99.6|116.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||116|99.6|
70920866|NCT01037985|141332519|SUPERIORITY||Median Difference (Final Values)|-0.9||||0.002|TWO_SIDED|95.0|-1.4|-0.4|||t-test, 2 sided|||Week 12, Relief: Comparison within the participant between EXC 001 and placebo.||-0.4|-1.4|0.002
70920867|NCT01037985|141332519|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.007|TWO_SIDED|95.0|-1.3|-0.2|||t-test, 2 sided|||Week 12, Pliability: Comparison within the participant between EXC 001 and placebo.||-0.2|-1.3|0.007
70920868|NCT01037985|141332519|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.214|TWO_SIDED|95.0|-1.1|0.3|||t-test, 2 sided|||Week 12, Surface Area: Comparison within the participant between EXC 001 and placebo.||0.3|-1.1|0.214
70920869|NCT01037985|141332519|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.003|TWO_SIDED|95.0|-1.5|-0.3|||t-test, 2 sided|||Week 12, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||-0.3|-1.5|0.003
70920870|NCT01037985|141332519|SUPERIORITY||Mean Difference (Final Values)|-5.0|||<|0.001|TWO_SIDED|95.0|-7.8|-2.2|||t-test, 2 sided|||Week 12, Composite Score: Comparison within the participant between EXC 001 and placebo.||-2.2|-7.8|<0.001
70920871|NCT01037985|141332519|SUPERIORITY||Mean Difference (Net)|0.1||||0.673|TWO_SIDED|95.0|-0.5|0.7|||t-test, 2 sided|||Week 24, Vascularity: Comparison within the participant between EXC 001 and placebo.||0.7|-0.5|0.673
70920872|NCT01037985|141332519|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.276|TWO_SIDED|95.0|-0.3|1.1|||t-test, 2 sided|||Week 24, Pigmentation: Comparison within the participant between EXC 001 and placebo.||1.1|-0.3|0.276
70920873|NCT01037985|141332519|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.67|TWO_SIDED|95.0|-0.7|0.5|||t-test, 2 sided|||Week 24, Thickness: Comparison within the participant between EXC 001 and placebo.||0.5|-0.7|0.670
71032723|NCT00834418|141574647|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-72 and Cmax.|Geometric Test/Ref Ratio x 100|102.0||||||90.0|95.2|109.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109|95.2|
70920874|NCT01037985|141332519|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-0.5|0.5|||t-test, 2 sided|||Week 24, Relief: Comparison within the participant between EXC 001 and placebo.||0.5|-0.5|1.000
70920875|NCT01037985|141332519|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.909|TWO_SIDED|95.0|-0.5|0.6|||t-test, 2 sided|||Week 24, Pliability: Comparison within the participant between EXC 001 and placebo.||0.6|-0.5|0.909
70920876|NCT01037985|141332519|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.852|TWO_SIDED|95.0|-0.6|0.8|||t-test, 2 sided|||Week 24, Surface Area: Comparison within the participant between EXC 001 and placebo.||0.8|-0.6|0.852
70920877|NCT01037985|141332519|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.906|TWO_SIDED|95.0|-0.5|0.6|||t-test, 2 sided|||Week 24, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||0.6|-0.5|0.906
70920878|NCT01037985|141332519|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.768|TWO_SIDED|95.0|-2.8|3.8|||t-test, 2 sided|||Week 24, Composite Score: Comparison within the participant between EXC 001 and placebo.||3.8|-2.8|0.768
70920879|NCT01037985|141332520|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.773|TWO_SIDED|95.0|-0.4|0.5|||t-test, 2 sided|||Week 12 Pain: Comparison within the participant between EXC 001 and placebo.||0.5|-0.4|0.773
70920880|NCT01037985|141332520|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-0.4|0.4|||t-test, 2 sided|||Week 12, Itching: Comparison within the participant between EXC 001 and placebo.||0.4|-0.4|1.000
70973697|NCT01077973|141454036|SUPERIORITY_OR_OTHER||Difference in proportion|6.47||||0.288|TWO_SIDED|95.0|-5.43|18.37||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.37|-5.43|0.288
70973698|NCT01077973|141454036|SUPERIORITY_OR_OTHER||Difference in proportion|-0.87||||0.928|TWO_SIDED|95.0|-20.0|18.27||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.27|-20.00|0.928
70973699|NCT01077973|141454036|SUPERIORITY_OR_OTHER||Difference in proportion|-6.4||||0.495|TWO_SIDED|95.0|-25.14|12.33||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.33|-25.14|0.495
70973700|NCT01077973|141454036|SUPERIORITY_OR_OTHER||Difference in proportion|5.46||||0.477|TWO_SIDED|95.0|-9.66|20.59||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.59|-9.66|0.477
70973701|NCT02499029|141454123|SUPERIORITY|||||||0.05|||||||Regression, Linear|||A series of hierarchical linear regression analyses were conducted to examine the effects of treatment group (NAC or placebo) on PTSD symptomatology, craving, substance use, and depression. Baseline levels of the respective outcome measures were entered in Step 1 of the model to adjust for any baseline differences. Treatment group was entered as the predictor in Step 2. The significance threshold was set at a p-value of .05 (two-sided) for all statistical tests.||||.05
70973702|NCT03889639|141454132|SUPERIORITY|Relative reduction in lesions in SAR442168 5 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95 percentage (%) confidence interval (CI) were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|-56.16||||0.1673|TWO_SIDED|95.0|-193.99|17.05|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 5 mg/Placebo||17.05|-193.99|0.1673
70973703|NCT03889639|141454132|SUPERIORITY|Relative reduction in lesions in SAR442168 15 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|-62.8||||0.354|TWO_SIDED|95.0|-356.24|41.91|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 15 mg/Placebo||41.91|-356.24|0.3540
70973704|NCT03889639|141454132|SUPERIORITY|Relative reduction in lesions in SAR442168 30 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|13.49||||0.7674|TWO_SIDED|95.0|-126.05|66.89|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 30 mg/Placebo||66.89|-126.05|0.7674
70973705|NCT03889639|141454132|SUPERIORITY|Relative reduction in lesions in SAR442168 60 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|85.02||||0.0178|TWO_SIDED|95.0|28.02|96.88|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 60 mg/Placebo||96.88|28.02|0.0178
70973706|NCT03889639|141454133|SUPERIORITY|Relative reduction in lesions in SAR442168 5 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model without adjusting for Baseline T2 lesion activity as all participants had at least one T2 lesion at Baseline.|Relative reduction in lesions|10.17||||0.7736|TWO_SIDED|95.0|-86.49|56.73|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 5 mg/Placebo||56.73|-86.49|0.7736
70973707|NCT03889639|141454133|SUPERIORITY|Relative reduction in lesions in SAR442168 15 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model without adjusting for Baseline T2 lesion activity as all participants had at least one T2 lesion at Baseline.|Relative reduction in lesions|37.07||||0.248|TWO_SIDED|95.0|-38.08|71.32|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 15 mg/Placebo||71.32|-38.08|0.2480
71032724|NCT01705574|141574648|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The null hypothesis was that the STB group was at least 12% worse than the ATV+RTV+TVD group with respect to the percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 (response rate as defined by the snapshot analysis algorithm). The alternative hypothesis was that the STB group was less than 12% worse than the ATV+RTV+TVD group.|Difference in proportions|6.5|||||TWO_SIDED|95.2|0.4|12.6|||||Difference in percentages of virologic success and its 95.2% confidence interval (CI) were calculated based on baseline HIV-1 RNA and race stratum-adjusted Mantel-Haenszel (MH) proportion.|||12.6|0.4|
71094966|NCT04018001|141698031|SUPERIORITY|||||||0.3584|||||||Chi-squared|||||||0.3584
71094967|NCT04018001|141698031|SUPERIORITY||Odds Ratio (OR)|1.1077385||||0.451|TWO_SIDED|95.0|0.8489444|1.4454238||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Logistic|||||1.4454238|0.8489444|0.4510
71094968|NCT04018001|141698032|SUPERIORITY|||||||0.0624|||||||Chi-squared|||||||0.0624
71094969|NCT04018001|141698033|SUPERIORITY|||||||0.4914|||||||Chi-squared|||||||0.4914
71094970|NCT02942407|141698049|NON_INFERIORITY|Due to a lower recruitment rate than anticipated in the early stage of the trial, the sample size was curtailed from 760 to 230 patients. Thus, under the initial protocol assumptions, the study is considered under-powered for the two-sided upper 95% CI on the HR to rule-out the non-inferiority margin of 1.40.|Hazard Ratio (HR)|1.2||||0.321|TWO_SIDED|95.0|0.63|2.3|||Regression, Cox|Cox model was adjusted for prior warfarin status (naive vs experienced) and treatment (apixaban vs warfarin)|Time from randomization to first occurrence of outcome was modeled. If no event, censored at earliest of: most recent date of evaluation of outcome, month 15 target (460 days + randomization date), or end of study date (July 27, 2019).|Exploratory analysis due to failure to reach initial sample size: Non-inferiority (NI) null hypothesis: HR \>= 1.4 (Non-inferiority).||2.3|0.63|0.321
70920881|NCT01037985|141332520|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.072|TWO_SIDED|95.0|-1.4|0.1|||t-test, 2 sided|||Week 12, Color: Comparison within the participant between EXC 001 and placebo.||0.1|-1.4|0.072
71032725|NCT01705574|141574648|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|6.5||||0.034|TWO_SIDED|95.2|0.4|12.6|||Cochran-Mantel-Haenszel|P-value comparing virologic success was from the CMH test stratified by baseline HIV-1 RNA and race strata.|Difference in percentages of virologic success and its 95.2% CI were calculated based on baseline HIV-1 RNA and race stratum-adjusted MH proportion. If the lower bound of the CI was \> 0, superiority of STB over ATV+RTV+TVD was established.|If noninferiority of STB versus ATV+RTV+TVD was established, the same 95.2% CI used in evaluating noninferiority was used to evaluate superiority. The baseline HIV-1 RNA and race stratum-stratified, 2-sided CMH test was also used to assess superiority as a secondary assessment.||12.6|0.4|0.034
71032726|NCT00089661|141574661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5|||<|0.0001||95.0|4.8|6.3|||ANCOVA|||||6.3|4.8|<0.0001
71032727|NCT02647944|141574675|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71032728|NCT02647944|141574676|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71032729|NCT02647944|141574677|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
71032730|NCT02647944|141574678|SUPERIORITY|||||||0.069|||||||Wilcoxon (Mann-Whitney)|||||||0.069
71032731|NCT02647944|141574679|SUPERIORITY|||||||0.054|||||||Wilcoxon (Mann-Whitney)|||||||0.054
71032732|NCT02647944|141574680|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
71094971|NCT02942407|141698049|SUPERIORITY|Exploratory analysis due to lack of achieving initial sample size.|Hazard Ratio (HR)|1.2||||0.583|TWO_SIDED|95.0|0.63|2.3||If upper limit of 95% confidence interval \< 1 this would be considered evidence of superiority.|Regression, Cox|Cox model was adjusted for prior warfarin status (naive vs experienced) and treatment (apixaban vs warfarin).|Time from randomization to first occurrence of outcome was modeled. If no event, censored at earliest of: most recent date of evaluation of outcome, month 15 target (460 days + randomization date), or end of study date (July 27, 2019).|||2.3|0.63|0.583
70920882|NCT01037985|141332520|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.851|TWO_SIDED|95.0|-0.7|0.6|||t-test, 2 sided|||Week 12, Stiffness: Comparison within the participant between EXC 001 and placebo.||0.6|-0.7|0.851
70920883|NCT01037985|141332520|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.184|TWO_SIDED|95.0|-1.2|0.2|||t-test, 2 sided|||Week 12, Thickness: Comparison within the participant between EXC 001 and placebo.||0.2|-1.2|0.184
70920884|NCT01037985|141332520|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.059|TWO_SIDED|95.0|-1.3|0.0|||t-test, 2 sided|||Week 12, Irregular: Comparison within the participant between EXC 001 and placebo.||0.0|-1.3|0.059
70920885|NCT01037985|141332520|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.04|TWO_SIDED|95.0|-1.5|0.0|||t-test, 2 sided|||Week 12, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||-0.0|-1.5|0.040
70920886|NCT01037985|141332520|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.12|TWO_SIDED|95.0|-4.1|0.5|||t-test, 2 sided|||Week 12, Composite Score: Comparison within the participant between EXC 001 and placebo.||0.5|-4.1|0.120
70920887|NCT01037985|141332520|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.094|TWO_SIDED|95.0|-4.0|0.3|||t-test, 2 sided|||Week 12, Scar Appearance Composite Score: Comparison within the participant between EXC 001 and placebo.||0.3|-4.0|0.094
70920888|NCT01037985|141332520|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.243|TWO_SIDED|95.0|-0.2|0.6|||t-test, 1 sided|||Week 24, Pain: Comparison within the participant between EXC 001 and placebo.||0.6|-0.2|0.243
70920889|NCT01037985|141332520|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.339|TWO_SIDED|95.0|-0.2|0.6|||t-test, 2 sided|||Week 24, Itching: Comparison within the participant between EXC 001 and placebo.||0.6|-0.2|0.339
71032733|NCT02647944|141574681|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
71032734|NCT02647944|141574682|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
70920890|NCT01037985|141332520|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.25|TWO_SIDED|95.0|-0.3|1.2|||t-test, 2 sided|||Week 24, Color: Comparison within the participant between EXC 001 and placebo.||1.2|-0.3|0.250
70920891|NCT01037985|141332520|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.164|TWO_SIDED|95.0|-1.3|0.2|||t-test, 2 sided|||Week 24, Stiffness: Comparison within the participant between EXC 001 and placebo.||0.2|-1.3|0.164
71032735|NCT02760368|141574689|SUPERIORITY||Risk Difference (RD)|0.378|||<|0.0001|TWO_SIDED|97.5|0.248|0.489|||Chi-squared|2x2 chi-square test||The OKZ ACR20 response rates for 64 q2w treatment group at Week 12 are expected to be at least 55%, resulting in an expected difference in ACR20 response rates of 30 percentage points between respective OKZ treatment group and placebo. Sample size yield 100% disjunctive power for testing the primary hypothesis.||0.489|0.248|<0.0001
71032736|NCT02760368|141574689|SUPERIORITY||Risk Difference (RD)|0.445|||<|0.0001|TWO_SIDED|97.5|0.318|0.552|||Chi-squared|2x2 chi-square test||The OKZ ACR20 response rates for 64 q4w treatment group at Week 12 are expected to be at least 50%, resulting in an expected difference in ACR20 response rates of 25 percentage points between respective OKZ treatment group and placebo. Sample size yield 100% disjunctive power for testing the primary hypothesis.||0.552|0.318|<0.0001
71032737|NCT02760368|141574690|SUPERIORITY||Risk Difference (RD)|0.294|||<|0.0001|TWO_SIDED|97.5|0.197|0.389|||Chi-squared|2x2 chi-square test||DAS28 low disease activity (based on DAS28 \[CRP\] \<3.2) response rate at Week 12 was estimated to be 10% in the placebo group and 30% in 64 q2w OKZ treatment groups respectively, resulting in an expected difference of 20 percentage points between OKZ q2w treatment group and placebo.||0.389|0.197|<0.0001
71154110|NCT03069352|141800769|OTHER||LS Mean Difference|2.917|STANDARD_ERROR_OF_MEAN|4.617|||TWO_SIDED|95.0|-6.23|12.06|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 3 Day 1||12.06|-6.23|
70920892|NCT01037985|141332520|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-0.8|0.8|||t-test, 2 sided|||Week 24, Thickness: Comparison within the participant between EXC 001 and placebo.||0.8|-0.8|1.000
70920893|NCT01037985|141332520|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.928|TWO_SIDED|95.0|-0.8|0.7|||t-test, 2 sided|||Week 24, Irregular: Comparison within the participant between EXC 001 and placebo.||0.7|-0.8|0.928
70920894|NCT01037985|141332520|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.865|TWO_SIDED|95.0|-0.8|0.7|||t-test, 2 sided|||Week 24, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||0.7|-0.8|0.865
70920895|NCT01037985|141332520|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.804|TWO_SIDED|95.0|-2.3|3.0|||t-test, 2 sided|||Week 24, Composite Score: Comparison within the participant between EXC 001 and placebo.||3.0|-2.3|0.804
70920896|NCT01037985|141332520|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.937|TWO_SIDED|95.0|-2.6|2.4|||t-test, 2 sided|||Week 24, Scar Appearance Composite Score: Comparison within the participant between EXC 001 and placebo.||2.4|-2.6|0.937
70920897|NCT02730871|141332527|SUPERIORITY||Mean Difference (Final Values)|-2.15|STANDARD_ERROR_OF_MEAN|0.342|<|0.001|TWO_SIDED|95.0|-2.8|-1.5|||ANCOVA|||||-1.5|-2.8|<0.001
70920898|NCT02730871|141332528|OTHER||Mean Difference (Final Values)|-2.15|STANDARD_ERROR_OF_MEAN|0.342|<|0.001|TWO_SIDED|95.0|-2.8|-1.5|||ANCOVA|||||-1.5|-2.8|<0.001
70920899|NCT02730871|141332529|OTHER||Mean Difference (Final Values)|-9.98|STANDARD_ERROR_OF_MEAN|1.572|<|0.001|TWO_SIDED|95.0|-13.1|-6.9|||ANCOVA|||||-6.9|-13.1|<0.001
70920900|NCT02730871|141332530|OTHER||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.576||0.022|TWO_SIDED|95.0|-2.5|-0.2|||Repeated measures model|||Change from Baseline in IOP at 9:00||-0.2|-2.5|0.022
70920901|NCT02730871|141332530|OTHER||Mean Difference (Final Values)|-2.85|STANDARD_ERROR_OF_MEAN|0.506|<|0.001|TWO_SIDED|95.0|-3.9|-1.9|||Repeated measures model|||Change from Baseline in IOP at 11:00||-1.9|-3.9|<0.001
70920902|NCT02730871|141332531|OTHER||Mean Difference (Final Values)|-6.15|STANDARD_ERROR_OF_MEAN|2.567||0.018|TWO_SIDED|95.0|-11.2|-1.1|||Repeated measures model|||Percentage Change from Baseline in IOP at 09:00||-1.1|-11.2|0.018
70920903|NCT02730871|141332531|OTHER||Mean Difference (Final Values)|-13.21|STANDARD_ERROR_OF_MEAN|2.34|<|0.001|TWO_SIDED|95.0|-17.8|-8.6|||Repeated measures model|||Percentage Change from Baseline in IOP at 11:00||-8.6|-17.8|<0.001
70920904|NCT01996605|141332548|SUPERIORITY||||||<|0.05||||||T|ANOVA|A one-way ANOVA was performed on the single primary outcome datapoint comparing the three groups.||The null hypothesis was that there would be no difference in area of hyperalgesia 105 minutes after study drug injection among the three groups.||||<0.05
70920905|NCT02769858|141332574|OTHER|||||||0.001|||||||t-test, 2 sided|||||||.001
70920906|NCT02769858|141332575|OTHER|||||||0.019|||||||t-test, 2 sided|||||||.019
70920907|NCT02769858|141332576|OTHER|||||||0.502|||||||t-test, 2 sided|||||||.502
70920908|NCT02807779|141332577|SUPERIORITY|||||||0.22||||||Threshold for statistical significance was p=0.05.|t-test, 2 sided|||"Power calculations were performed based on an expected reproducibility variance of 8% and an effect size of 7% was assumed based on data from pilot studies. It was estimated that 22 subjects/treatment assignment were needed to detect a 7% difference in PWV at a power level of 80%. Assigning a 20% attrition rate due to loss to follow up or index lesion revascularization, the goal enrollment was 27 subjects per arm.~No subjects in the plain balloon angioplasty group had MRI data for analysis."||||0.22
70920909|NCT02807779|141332578|SUPERIORITY|||||||0.64||||||Threshold for statistical significance was p=0.05.|t-test, 2 sided|||No subjects in the plain balloon angioplasty group had MRI data for analysis.||||0.64
70920910|NCT02807779|141332579|SUPERIORITY|||||||0.95||||||Threshold for statistical significance was p=0.05.|t-test, 2 sided|||No subjects in the plain balloon angioplasty group had complete MCP-1 data for analysis.||||0.95
70920911|NCT02807779|141332580|SUPERIORITY|||||||0.88||||||Threshold for statistical significance was p=0.05.|t-test, 2 sided|||No subjects in the plain balloon angioplasty group had complete CRP data for analysis.||||0.88
70920912|NCT02807779|141332582|SUPERIORITY|||||||0.055||||||Threshold for statistical significance was p=0.05.|t-test, 2 sided|||No subjects in the plain balloon angioplasty group had MRI data for analysis.||||.055
70920913|NCT02807779|141332583|SUPERIORITY|||||||0.22||||||Threshold for statistical significance was p=0.05.|t-test, 2 sided|||No subjects in the plain balloon angioplasty group had MRI data for analysis.||||.22
70920914|NCT02807779|141332584|SUPERIORITY|||||||0.81||||||Threshold for statistical significance was p=0.05.|Fisher Exact|||||||0.81
70920915|NCT01853748|141332645|SUPERIORITY|||||||0.0012|||||||Mantel Haenszel|||||||0.0012
70920916|NCT01853748|141332650|SUPERIORITY|||||||0.0001|||||||Regression, Linear|||||||0.0001
70920917|NCT01853748|141332653|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||||||0.0001
70920918|NCT06336629|141332665|SUPERIORITY||two-sided|100.0|||||TWO_SIDED|95.0||||||||||||
70920919|NCT06336629|141332666|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
70920920|NCT06336629|141332667|SUPERIORITY|||||||0.007|||||||Wilcoxon rank-sum test|||||||0.007
70920921|NCT06336629|141332668|SUPERIORITY|||||||0.009|||||||Wilcoxon rank sum test|||||||0.009
70920922|NCT06336629|141332669|SUPERIORITY|||||||0.037||||||P-value from Baseline at Week 16|Wilcoxon signed rank|P-value from Baseline at Week 16||||||0.037
70920923|NCT06336629|141332671|SUPERIORITY|||||||1||||||P-value from Baseline at Week 16|Wilcoxon signed rank|||||||1
70920924|NCT06336629|141332672|SUPERIORITY|||||||1||||||P-value from Baseline at Week 16|Wilcoxon signed rank|||||||1
70920925|NCT04043455|141332675|SUPERIORITY||Least square mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.407|=|0.65|TWO_SIDED|95.0|-0.99|0.62|||Mixed Models Analysis|||Treatment comparison between Olorinab 10 mg and placebo using least square mean difference and 95% confidence interval (CI) has been presented.||0.62|-0.99|=0.650
70920926|NCT04043455|141332675|SUPERIORITY||Least square mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.409|=|0.439|TWO_SIDED|95.0|-1.12|0.49|||Mixed Models Analysis|||Treatment comparison between Olorinab 25 mg and placebo using least square mean difference and 95% CI has been presented.||0.49|-1.12|=0.439
71094972|NCT02942407|141698051|SUPERIORITY||Hazard Ratio (HR)|1.47|||||TWO_SIDED|95.0|0.74|2.93||No p-value provided as analysis is considered exploratory due to study being under powered.||||Hazard ratios (apixaban vs warfarin) and 95% confidence intervals obtained using Cox model adjusted for prior warfarin status (naive vs experienced) and treatment. Time from randomization to first occurrence of the composite outcome/censoring date modeled. Those that did not experience the outcome are censored at the earliest of the following: 1) most recent date of evaluation of all of the components, 2) month 15 target (460 days + randomization date), and end of study date (July 27, 2019).||2.93|0.74|
71094973|NCT02942407|141698060|SUPERIORITY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.67|2.17||No p-value provided as analysis is considered exploratory due to study being under powered.||||Hazard ratios (apixaban vs warfarin) and 95% confidence intervals obtained using Cox model adjusted for prior warfarin status (naive vs experienced) and treatment. Time from randomization to first occurrence of the composite outcome/censoring date modeled. Those that did not experience the outcome are censored at the earliest of the following: 1) most recent date of evaluation of all of the components, 2) month 15 target (460 days + randomization date), and end of stud date (July 27, 2019).||2.17|0.67|
71094974|NCT03925220|141698071|SUPERIORITY||Prevalence Ratio (PR)|2.86|||<|0.001|TWO_SIDED|95.0|2.02|4.04||"At 3 months:~Parent-reported frequency of conversations on drinking alcohol"|Generalized estimation|||A sample size of 400 parents and children was calculated to yield 80% power to detect one or more differences between the intervention and control arms, of 45% in talking about alcohol, 20% about marijuana, and 20% about other drugs, using a two-sided Bonferroni-corrected 1.5% level of significance (based on estimates from the pilot trial).||4.04|2.02|<0.001
71094975|NCT03925220|141698071|SUPERIORITY||Prevalence Ratio [PR]|2.4|||<|0.001|TWO_SIDED|95.0|1.67|3.45||"At 3 months:~Parent-reported frequency of conversations on using e-cigarettes or vaping"|Generalized estimation|||||3.45|1.67|<0.001
71094976|NCT03925220|141698071|SUPERIORITY||Prevalence Ratio [PR]|2.36|||<|0.001|TWO_SIDED|95.0|1.62|3.43||"At 3 months:~Parent-reported frequency of conversations on using marijuana"|Generalized estimation|||||3.43|1.62|<0.001
71094977|NCT03925220|141698071|SUPERIORITY||Prevalence Ratio [PR]|3.45|||<|0.001|TWO_SIDED|95.0|2.34|5.08||"At 3 months:~Parent-reported frequency of conversations on smoking cigarettes"|Generalized estimation|||||5.08|2.34|<0.001
71094978|NCT03925220|141698071|SUPERIORITY||Prevalence Ratio [PR]|2.47|||<|0.001|TWO_SIDED|95.0|1.58|3.86||"At 3 months:~Parent-reported frequency of conversations on using other drugs"|Generalized estimation|||||3.86|1.58|<0.001
71094979|NCT03925220|141698071|SUPERIORITY||Prevalence Ratio [PR]|1.45||||0.04|TWO_SIDED|95.0|1.02|2.06||"At 18 months:~Parent-reported frequency of conversations on drinking alcohol"|Generalized estimation|||||2.06|1.02|0.04
71094980|NCT03925220|141698072|SUPERIORITY||Prevalence Ratio (PR)|1.31|||<|0.001|TWO_SIDED|95.0|1.18|1.45||"At 3 months:~Parent-reported have warned your child about the dangers of drinking alcohol and using drugs"|Generalized estimation|||||1.45|1.18|<0.001
70973708|NCT03889639|141454133|SUPERIORITY|Relative reduction in lesions in SAR442168 30 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model without adjusting for Baseline T2 lesion activity as all participants had at least one T2 lesion at Baseline.|Relative reduction in lesions|38.5||||0.3081|TWO_SIDED|95.0|-56.61|75.85|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 30 mg/Placebo||75.85|-56.61|0.3081
70973709|NCT03889639|141454133|SUPERIORITY|Relative reduction in lesions in SAR442168 60 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model without adjusting for Baseline T2 lesion activity as all participants had at least one T2 lesion at Baseline.|Relative reduction in lesions|89.34||||0.0001|TWO_SIDED|95.0|68.39|96.41|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 60 mg/Placebo||96.41|68.39|0.0001
71094981|NCT03925220|141698072|SUPERIORITY||Prevalence Ratio [PR]|1.55|||<|0.001|TWO_SIDED|95.0|1.32|1.83||"At 3 months:~Parent-reported 'have talked to your child about how to handle offers of alcoholic drinks and drugs'"|Generalized estimation|||||1.83|1.32|<0.001
71094982|NCT03925220|141698072|SUPERIORITY||Prevalence Ratio [PR]|2.13|||<|0.001|TWO_SIDED|95.0|1.73|2.63||"At 3 months:~Parent-reported 'have given your child rules to obey about drinking alcohol and using drugs'"|Generalized estimation|||||2.63|1.73|<0.001
71094983|NCT03925220|141698072|SUPERIORITY||Prevalence Ratio [PR]|1.67||||0.001|TWO_SIDED|95.0|1.25|2.25||"At 3 months:~Parent-reported 'have lectured or given your child a speech about drinking alcohol and using drugs'"|Generalized estimation|||||2.25|1.25|0.001
71094984|NCT03925220|141698072|SUPERIORITY||Prevalence Ratio [PR]|1.51|||<|0.001|TWO_SIDED|95.0|1.21|1.9||"At 3 months:~Parent-reported 'have made a comment to your child about how drinking alcohol and using drugs is bad if a character on TV is drinking or drunk'"|Generalized estimation|||||1.90|1.21|<0.001
71094985|NCT03925220|141698072|SUPERIORITY||Prevalence Ratio [PR]|1.25||||0.008|TWO_SIDED|95.0|1.06|1.47||"At 3 months:~Parent-reported 'have told your child stories of people who drink alcohol, have been drunk, or use drugs'"|Generalized estimation|||||1.47|1.06|0.008
71094986|NCT03925220|141698072|SUPERIORITY||Prevalence Ratio [PR]|1.65|||<|0.001|TWO_SIDED|95.0|1.29|2.1||"At 3 months:~Parent-reported 'have told your child you would be disappointed in her/him if they were to drink alcohol or use drugs'"|Generalized estimation|||||2.10|1.29|<0.001
71094987|NCT03925220|141698072|SUPERIORITY||Prevalence Ratio [PR]|1.64|||<|0.001|TWO_SIDED|95.0|1.24|2.15||"At 3 months:~Parent-reported 'have shown your child information on the web, TV, or in the news about the dangers of drinking alcohol and using drugs'"|Generalized estimation|||||2.15|1.24|<0.001
71094988|NCT03925220|141698072|SUPERIORITY||Prevalence Ratio [PR]|1.65|||<|0.001|TWO_SIDED|95.0|1.4|1.93||"At 3 months:~Parent-reported 'have asked your child about their thoughts and opinions about drinking alcohol and using drugs'"|Generalized estimation|||||1.93|1.40|<0.001
71094989|NCT03925220|141698072|SUPERIORITY||Prevalence Ratio [PR]|1.4||||0.003|TWO_SIDED|95.0|1.12|1.74||"At 18 months:~Parent-reported 'have given your child rules to obey about drinking alcohol and using drugs'"|Generalized estimation|||||1.74|1.12|0.003
71094990|NCT03925220|141698072|SUPERIORITY||Prevalence Ratio [PR]|1.38||||0.01|TWO_SIDED|95.0|1.06|1.78||"At 18 months:~Parent-reported 'have made a comment to your child about how drinking alcohol and using drugs is bad if a character on TV is drinking or drunk'"|Generalized estimation|||||1.78|1.06|0.01
71094991|NCT05561140|141698088|SUPERIORITY||Difference in percentage|-0.3|||=|1|TWO_SIDED|95.0|-10.9|10.2|||Cochran-Mantel-Haenszel|||||10.2|-10.9|=1.0000
71032738|NCT02760368|141574690|SUPERIORITY||Risk Difference (RD)|0.352|||<|0.0001|TWO_SIDED|97.5|0.251|0.449|||Chi-squared|2x2 chi-square test||DAS28 low disease activity (based on DAS28 \[CRP\] \<3.2) response rate at Week 12 was estimated to be 10% in the placebo group and 22% in 64 mg q4w OKZ treatment group respectively, resulting in an expected difference of 12 percentage points between OKZ q4w treatment group and placebo.||0.449|0.251|<0.0001
71032739|NCT02760368|141574691|SUPERIORITY||Least Squares Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|97.5|-0.47|-0.21|||ANCOVA|||||-0.21|-0.47|<0.0001
71032740|NCT02760368|141574691|SUPERIORITY||Least Squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|97.5|-0.49|-0.23|||ANCOVA|||||-0.23|-0.49|<0.0001
71032741|NCT02760368|141574692|SUPERIORITY||Risk Difference (RD)|0.35|||<|0.0001|TWO_SIDED|97.5|0.239|0.45|||Chi-squared|2x2 chi-square test||||0.450|0.239|<0.0001
71032742|NCT02760368|141574692|SUPERIORITY||Risk Difference (RD)|0.409|||<|0.0001|TWO_SIDED|97.5|0.296|0.509|||Chi-squared|2x2 chi-square test||||0.509|0.296|<0.0001
71032743|NCT02760368|141574693|SUPERIORITY||Risk Difference (RD)|0.084|||<|0.0002|TWO_SIDED|97.5|0.032|0.151||2x2 chi-square test|Chi-squared|||||0.151|0.032|<0.0002
71032744|NCT02760368|141574693|SUPERIORITY||Risk Difference (RD)|0.077|||<|0.0003|TWO_SIDED|97.5|0.027|0.143||2x2 chi-square test|Chi-squared|||||0.143|0.027|<0.0003
71032745|NCT01860521|141574745|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
71032746|NCT01860521|141574746|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.005
71032747|NCT01860521|141574747|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.047
71154111|NCT03069352|141800769|OTHER||LS Mean Difference|13.388|STANDARD_ERROR_OF_MEAN|5.659|||TWO_SIDED|95.0|2.18|24.59|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 5 Day 1||24.59|2.18|
71032748|NCT01860521|141574748|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.047
71032749|NCT01513174|141574756|SUPERIORITY||Hazard Ratio (HR)|1.38||||0.124|TWO_SIDED|95.0|1.0|1.92|||Log Rank||||The initial hypothesis estimated that the median PFS for the gefitinib group would be 10 months, while the median PFS for the gefitinib/olaparib group would be 16 months, which implied a hazard ratio (HR) of 1.6.|1.92|1.00|0.124
71032750|NCT01513174|141574757|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.3455|TWO_SIDED|95.0|0.806|1.845|||Log Rank|||||1.845|0.806|0.3455
71032751|NCT00467363|141574773|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.0984|TWO_SIDED|95.0|0.98|1.22||Only one outcome for primary outcome, so no adjustment of p-value for multiple comparisons was done. A priori threshold for statistical significance was p\<0.05.|Fisher Exact|No adjustments were done. Treatment groups were similar with respect to the assessed demographic and baseline characteristics||The study was designed to detect a 10% absolute difference in livebirth rate with 80% power and a type I error rate of 5%, on the assumption that participants taking placebo who achieved pregnancy would have a livebirth rate of 75%.||1.22|0.98|0.0984
71032752|NCT00467363|141574774|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.0165|TWO_SIDED|95.0|1.02|1.19|||Fisher Exact|||||1.19|1.02|.0165
71032753|NCT00467363|141574775|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.0329|TWO_SIDED|95.0|1.01|1.19|||Fisher Exact|||||1.19|1.01|.0329
71032754|NCT00467363|141574776|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.06||||0.8902|TWO_SIDED|95.0|0.64|1.78|||Fisher Exact|||||1.78|.64|.8902
71032755|NCT00467363|141574777|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08||||0.6869|TWO_SIDED|95.0|0.76|1.55|||Fisher Exact|||||1.55|.76|.6869
71032756|NCT00467363|141574778|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.68||||0.753|TWO_SIDED|95.0|0.19|2.41|||Fisher Exact|||||2.41|.19|.7530
71032757|NCT00467363|141574779|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||1|TWO_SIDED|95.0|0.15|7.26|||Fisher Exact|||||7.26|.15|1.000
71032758|NCT00467363|141574780|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||1|TWO_SIDED|95.0|0.21|5.06|||Fisher Exact|||||5.06|.21|1.000
71032759|NCT00467363|141574781|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||1|TWO_SIDED|95.0|0.21|5.06|||Fisher Exact|||||5.06|.21|1.000
71032760|NCT00467363|141574782|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08||||0.7943|TWO_SIDED|95.0|0.67|1.76|||Fisher Exact|||||1.76|.67|.7943
71032761|NCT00467363|141574783|SUPERIORITY_OR_OTHER|||||||0.7802|||||||t-test, 2 sided|||||||.7802
71032762|NCT00467363|141574784|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.72||||0.2603|TWO_SIDED|95.0|0.42|1.23|||Fisher Exact|||||1.23|.42|.2603
71032763|NCT00467363|141574787|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.3||||0.77|TWO_SIDED|95.0|-0.8|1.4|||Fisher Exact|||||1.4|-0.8|0.77
71032764|NCT02757105|141574791|SUPERIORITY|||||||0.036|||||||Chi-squared, Corrected|||||||0.036
71032765|NCT02757105|141574792|SUPERIORITY|||||||0.41|||||||Chi-squared, Corrected|||||||0.410
71032766|NCT02757105|141574793|SUPERIORITY|||||||0.081|||||||Chi-squared, Corrected|||||||0.081
71032767|NCT02757105|141574794|SUPERIORITY|||||||0.042|||||||Chi-squared, Corrected|||||||0.042
71032768|NCT02757105|141574795|SUPERIORITY|||||||0.009|||||||Chi-squared, Corrected|||||||0.009
71032769|NCT02757105|141574796|SUPERIORITY|||||||0.919|||||||Chi-squared, Corrected|||||||0.919
71032770|NCT02757105|141574797|SUPERIORITY||Mean Difference (Final Values)|11.5||||0.278|TWO_SIDED|95.0|-7.7|30.6|||Chi-squared, Corrected|||||30.6|-7.7|0.278
71032771|NCT02757105|141574798|SUPERIORITY||Mean Difference (Final Values)|14.5||||0.135|TWO_SIDED|95.0|-3.4|32.5|||Chi-squared, Corrected|||||32.5|-3.4|0.135
71032772|NCT00473330|141574818|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|24.3|||<|0.0001|TWO_SIDED|95.0|13.8|34.8||An adjustment was made for multiple treatment comparisons of the ranibizumab dose groups with the control group.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||34.8|13.8|<0.0001
71154112|NCT03069352|141800769|OTHER||LS Mean Difference|7.119|STANDARD_ERROR_OF_MEAN|6.031|||TWO_SIDED|95.0|-4.83|19.06|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 7 Day 1||19.06|-4.83|
71154113|NCT03069352|141800769|OTHER||LS Mean Difference|6.381|STANDARD_ERROR_OF_MEAN|7.511|||TWO_SIDED|95.0|-8.49|21.26|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 9 Day 1||21.26|-8.49|
70920927|NCT04043455|141332675|SUPERIORITY||Least square mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.401|=|0.172|TWO_SIDED|95.0|-1.34|0.24|||Mixed Models Analysis|||Treatment comparison between Olorinab 50 mg and placebo using least square mean difference and 95% CI has been presented.||0.24|-1.34|=0.172
70920928|NCT04043455|141332682|SUPERIORITY||Odds Ratio (OR)|1.156||||0.659|TWO_SIDED|95.0|-0.019|2.331|||Cochran-Mantel-Haenszel|||Treatment comparison between Olorinab 10 mg and placebo using Odds ratio and 95% CI has been presented.||2.331|-0.019|0.659
70920929|NCT04043455|141332682|SUPERIORITY||Odds Ratio (OR)|1.248||||0.557|TWO_SIDED|95.0|-0.04|2.535|||Cochran-Mantel-Haenszel|||Treatment comparison between Olorinab 25 mg and placebo using Odds ratio and 95% CI has been presented.||2.535|-0.040|0.557
70920930|NCT04043455|141332682|SUPERIORITY||Odds Ratio (OR)|1.245||||0.541|TWO_SIDED|95.0|0.027|2.462|||Cochran-Mantel-Haenszel|||Treatment comparison between Olorinab 50 mg and placebo using Odds ratio and 95% CI has been presented.||2.462|0.027|0.541
70920931|NCT04043455|141332683|SUPERIORITY||Odds Ratio (OR)|1.234||||0.529|TWO_SIDED|95.0|-0.001|2.468|||Cochran-Mantel-Haenszel|||Treatment comparison between Olorinab 10 mg and placebo using Odd's ratio and 95% CI has been presented.||2.468|-0.001|0.529
70920932|NCT04043455|141332683|SUPERIORITY||Odds Ratio (OR)|1.123||||0.73|TWO_SIDED|95.0|0.015|2.232|||Cochran-Mantel-Haenszel|||Treatment comparison between Olorinab 25 mg and placebo using Odd's ratio and 95% CI has been presented.||2.232|0.015|0.730
70920933|NCT04043455|141332683|SUPERIORITY||Odds Ratio (OR)|1.226||||0.548|TWO_SIDED|95.0|0.025|2.428|||Cochran-Mantel-Haenszel|||Treatment comparison between Olorinab 50 mg and placebo using Odd's ratio and 95% CI has been presented.||2.428|0.025|0.548
70920934|NCT04043455|141332684|SUPERIORITY||Least square mean difference|-2.42|STANDARD_ERROR_OF_MEAN|6.189||0.696|TWO_SIDED|95.0|-14.61|9.76|||Mixed Models Analysis|||Treatment comparison between Olorinab 10 mg and placebo using least square mean difference and 95% CI has been presented.||9.76|-14.61|0.696
70920935|NCT04043455|141332684|SUPERIORITY||Least square mean difference|-3.25|STANDARD_ERROR_OF_MEAN|6.222||0.602|TWO_SIDED|95.0|-15.51|9.0|||Mixed Models Analysis|||Treatment comparison between Olorinab 25 mg and placebo using least square mean difference and 95% CI has been presented.||9.00|-15.51|0.602
70920936|NCT04043455|141332684|SUPERIORITY||Least square mean difference|-3.96|STANDARD_ERROR_OF_MEAN|6.088||0.516|TWO_SIDED|95.0|-15.95|8.03|||Mixed Models Analysis|||Treatment comparison between Olorinab 50 mg and placebo using least square mean difference and 95% CI has been presented.||8.03|-15.95|0.516
70920937|NCT04043455|141332685|SUPERIORITY||Least square mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.305||0.804|TWO_SIDED|95.0|-0.53|0.68|||Mixed Models Analysis|||Treatment comparison between Olorinab 10 mg and placebo using least square mean difference and 95% CI has been presented.||0.68|-0.53|0.804
70920938|NCT04043455|141332685|SUPERIORITY||Least square mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.308||0.618|TWO_SIDED|95.0|-0.76|0.45|||Mixed Models Analysis|||Treatment comparison between Olorinab 25 mg and placebo using least square mean difference and 95% CI has been presented.||0.45|-0.76|0.618
70920939|NCT04043455|141332685|SUPERIORITY||Least square mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.301||0.687|TWO_SIDED|95.0|-0.47|0.71|||Mixed Models Analysis|||Treatment comparison between Olorinab 50 mg and placebo using least square mean difference and 95% CI has been presented.||0.71|-0.47|0.687
70920940|NCT04922021|141332718|SUPERIORITY|Two-sided hypotheses were tested based on the pre-specified primary analysis for the primary estimand. The primary estimand used a hypothetical strategy evaluating the treatment difference as if all subjects adhered to the treatment regimen, i.e. they did not discontinue IMP permanently, did not initiate rescue treatment, or did not have more than one missed treatment dose related to COVID-19.|Mean Difference (Net)|-11.8||||0.003|TWO_SIDED|95.0|-19.6|-4.1||The type I error rate of the two-sided hypothesis test was controlled at the 5% significance level.|ANCOVA|ANCOVA model: Change in EASI = Treatment + Region + Baseline EASI. Missing values and data 'treated as missing' were imputed using MI assuming MAR.|Estimates of difference in LS-means and associated standard errors from the analyses were combined using Rubin's rule to provide the overall pooled estimate and associated standard error. LS-means was estimated using the observed margins for the FAS.|||-4.1|-19.6|0.003
70920941|NCT01285999|141332736|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29||||0.05|TWO_SIDED|95.0|-0.37|-0.21||p-value has not been adjusted.|t-test, 2 sided|No adjustment.||H0: μt - μc = 0 H1: μt - μc ≠ 0 where μt and μc are the mean 9-month in-stent late loss values for the subjects in the PROMUS Element test and TAXUS Liberté control treatment groups, respectively.||-0.21|-0.37|0.05
70920942|NCT04928001|141332890|SUPERIORITY||Mean Difference (Final Values)|31.0||||0.01|TWO_SIDED|95.0|0.0|60.0|||t-test, 1 sided|||||60|0|.01
70920943|NCT01693120|141332891|SUPERIORITY||rate|1.6||||0.175|ONE_SIDED|95.0||4.9|||exact binomial test|||The null hypothesis was that the procedure or device related stroke rate within 30-days of a Phased RF ablation procedure was 3.5% or greater. The alternative hypothesis was that this rate was less than 3.5%. A sample size of 300 subjects provided 90% power to test the null hypothesis assuming the true stroke rate was 1.0% with a one-sided type I error rate of 0.05||4.9||0.175
70920944|NCT01693120|141332892|OTHER|The goal of the analysis was to compute a two-sided 95% confidence interval around the 6-month effectiveness rate. There was no pre-specified hypothesis.|rate|52.6|||||TWO_SIDED|95.0|43.1|62.1||||||||62.1|43.1|
70920945|NCT01693120|141332893|OTHER|There was no prespecified hypothesis tested.|rate|90.7|||||TWO_SIDED|95.0|84.3|95.1||||||There was no prespecified hypothesis tested.||95.1|84.3|
70920946|NCT01693120|141332894|OTHER|There was no pre-specified hypothesis to test|rate|0.0|||||TWO_SIDED|95.0|0.0|6.1||||||There was no pre-specified hypothesis to test||6.1|0|
70920947|NCT03990649|141332963|SUPERIORITY|||||||0.54||||||The p-values were estimated using a two-sample t-test.|t-test, 2 sided|||||||0.540
70920948|NCT03050814|141332970|OTHER||Hazard Ratio (HR)|1.061||||0.91|TWO_SIDED|95.0|0.38|2.966|||Kaplan Meier|Kaplan-Meier curves and a two-tailed log-rank test||||2.966|0.380|0.91
71154114|NCT03069352|141800769|SUPERIORITY|||||||0.085|||||||Linear Mixed Effects Regression Model|Model included AML status (de novo vs. secondary), age (18-\< 75 vs. ≥ 75), treatment arm, time, and treatment arm by time interaction as fixed factors||A linear mixed effects regression model with a variable covariance structure was fitted to the longitudinal data (considering all time points) to test for differences between treatment arms.||||0.085
71032773|NCT00473330|141574818|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|20.9||||0.0002|TWO_SIDED|95.0|10.7|31.1||An adjustment was made for multiple treatment comparisons of the ranibizumab dose groups with the control group.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||31.1|10.7|0.0002
71032774|NCT00473330|141574819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.6|||<|0.0001|TWO_SIDED|95.0|6.1|13.0||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||13.0|6.1|<0.0001
71032775|NCT00473330|141574819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.4|||<|0.0001|TWO_SIDED|95.0|6.2|12.6||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||12.6|6.2|<0.0001
71094992|NCT05561140|141698090|SUPERIORITY||Least Square (LS) Mean Difference|-8.2|||=|0.0297|TWO_SIDED|95.0|-15.6|-0.8|||Mixed Models Analysis|||The mixed model for repeated measures (MMRM) model contained fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction with additional fixed effects for stratification factors.||-0.8|-15.6|=0.0297
71094993|NCT05561140|141698091|SUPERIORITY||Difference in percentage|-8.1|||=|0.3456|TWO_SIDED|95.0|-26.9|10.7|||Cochran-Mantel-Haenszel|||||10.7|-26.9|=0.3456
70920949|NCT01443845|141332973|SUPERIORITY_OR_OTHER||Rate Ratio|0.92|STANDARD_ERROR_OF_MEAN|0.063||0.1634|TWO_SIDED|95.0|0.81|1.04|||negative binomial regression||p-values are based on a negative binomial regression with factors Treatment and LAMA use.|Rate ratio (Roflumilast/Placebo). A rate ratio \< 1 represents a favorable outcome for the test treatment.||1.04|0.81|0.1634
70920950|NCT01443845|141332973|SUPERIORITY_OR_OTHER||Rate Ratio|0.83|STANDARD_ERROR_OF_MEAN|0.08||0.0195|TWO_SIDED|95.0|0.71|0.97|||negative binomial regression|||Subgroup Analysis - By Sex - Male||0.97|0.71|0.0195
70920951|NCT01443845|141332973|SUPERIORITY_OR_OTHER||Rate Ratio|1.11|STANDARD_ERROR_OF_MEAN|0.101||0.3164|TWO_SIDED|95.0|0.91|1.35|||negative binomial regression|||Subgroup Analysis - By Sex - Female||1.35|0.91|0.3164
70920952|NCT01443845|141332973|SUPERIORITY_OR_OTHER||Rate Ratio|0.85|STANDARD_ERROR_OF_MEAN|0.076||0.0385|TWO_SIDED|95.0|0.74|0.99|||negative binomial regression|||Subgroup analysis between patients taking Advair verses patients taking Symbicort as LABA/ICS therapy.||0.99|0.74|0.0385
70920953|NCT01443845|141332973|SUPERIORITY_OR_OTHER||Rate Ratio|1.05|STANDARD_ERROR_OF_MEAN|0.114||0.6475|TWO_SIDED|95.0|0.84|1.32|||negative binomial regression|||Subgroup analysis between patients taking Advair verses patients taking Symbicort as LABA/ICS therapy.||1.32|0.84|0.6475
70920954|NCT01443845|141332974|SUPERIORITY_OR_OTHER||Rate Ratio|0.95|STANDARD_ERROR_OF_MEAN|0.118||0.6354|TWO_SIDED|95.0|0.75|1.19|||negative binomial regression|||||1.19|0.75|0.6354
70920955|NCT01443845|141332975|SUPERIORITY_OR_OTHER||Rate Ratio|0.9|STANDARD_ERROR_OF_MEAN|0.06||0.0884|TWO_SIDED|95.0|0.8|1.02|||negative binomial regression|||||1.02|0.8|0.0884
70920956|NCT01443845|141332976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0532|STANDARD_ERROR_OF_MEAN|0.0067|<|0.0001|TWO_SIDED|95.0|0.04|0.0664||The MMRM analysis is based on all postbaseline observed data using a mixed model with terms for treatment, baseline, visit, LAMA use, treatment-by-visit and baseline-by-visit interactions.|Mixed Model for Repeated Measures (MMRM)|||||0.0664|0.04|< 0.0001
70920957|NCT00431834|141333009|SUPERIORITY_OR_OTHER||binomial proportions|37.7|||<|0.0041|ONE_SIDED|97.5|25.6|||The percent of patients off Class I and III AADs and successfully converted out of AF following treatment (ptest) will exceed the percenter of patients off Class I and III AADs and convereted out of AF, as reported in literature (pcontrol=22.1%)|Fisher Exact|||"The specific test hypothesis is as follows:~H0: ptest ≤ 22.1% Ha: ptest \> 22.1%"|||25.6|<0.0041
70920958|NCT00431834|141333012|SUPERIORITY_OR_OTHER||binomial proportions|5.3|||<|0.0001|ONE_SIDED|97.5||13.1||The percent of subjects following treatment, p, who experience any of the MAEs during the first 30 days following surgery, or hospital discharge, whichever is longer will be less than 23.6%.|Fisher Exact|||"The specific test hypothesis is as follows:~H0: p ≥ 23.6% Ha: p \< 23.6%"||13.1||<0.0001
70920959|NCT03628885|141333017|SUPERIORITY||||||<|0.02||||||Adjusted for mother's educational level, which differed across groups. A priori threshold for statistical significance = P\<.05|ANOVA|||||||<.02
70920960|NCT03628885|141333017|SUPERIORITY||||||=|0.07||||||Adjusted for mother's educational level, which differed across groups. A priori threshold for statistical significance = P\<.05|ANOVA|||||||=.07
70920961|NCT03628885|141333017|SUPERIORITY||||||<|0.01||||||Adjusted for mother's educational level, which differed across groups. A priori threshold for statistical significance = P\<.05|ANOVA|||Adjusted for mother's educational level, which differed across groups. A priori threshold for statistical significance = P\<.05||||<.01
70920962|NCT00324350|141333023|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.678|TWO_SIDED|95.0|0.86|1.27||Analyses were by intention to treat. All analyses adjusted for baseline cardiovascular disease, assignment to blood pressure (BP) trial or lipid trial, assignment to intensive BP intervention in BP trial, and assignment to fibrate in lipid trial.|Regression, Cox|||The BONE ancillary study was designed to have 80% power to detect a relative reduction in risk of non-spine clinical fractures of 22-29%. This was based on an estimated total number of fractures between 259-494, calculated with the following assumptions: rate of clinical non-spine fracture among women in the standard glycemia therapy group between 15 and 25/1000 person yrs, fracture rates for men between 35-40% of the rates for women of the same age, and an avg follow-up time of 4.6 yrs.||1.27|0.86|0.678
70920963|NCT00324350|141333024|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.49|TWO_SIDED|95.0|0.84|1.43|||Regression, Cox|||Number of participants with falls reported at each annual visit were compared by treatment assignment using a repeated-measures negative binomial model, with robust standard errors to account for clustering of the repeated outcomes within participants; the log of the length of the reporting period varied slightly and was included as an offset||1.43|0.84|0.490
70920964|NCT00324350|141333025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.854|TWO_SIDED|95.0|0.88|1.11|||Mixed Models Analysis||The rate of height loss did not differ between groups (p = 0.573). Height loss of \>2 cm during ACCORD was experienced by 678 (19.5%) participants in the intensive and 686 (19.6%) in the standard glycemia group (OR 0.99; 95% CI 0.88, 1.11).|Height loss was compared by treatment assignment using linear mixed models with random intercepts and slopes. The proportions losing \>2 cm of height during follow-up were compared using logistic models. Based on previous research by Siminoski et al., this degree of height loss is associated with incident vertebral fracture with 94% specificity but only 28% sensitivity.(Siminoski K, Jiang G, Adachi JD, et al. Osteoporos Int 2005;16:403-410)||1.11|0.88|0.854
70920965|NCT02015520|141333028|SUPERIORITY|||||||0.38|||||||Mixed Models Analysis|||||||0.38
70920966|NCT02015520|141333028|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70920967|NCT02015520|141333028|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70920968|NCT05119855|141333036|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-concomitant Group. GMT Ratio is reported for Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.22|||||TWO_SIDED|95.0|0.92|1.61|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 6||1.61|0.92|
70920969|NCT05119855|141333036|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.33|||||TWO_SIDED|95.0|1.01|1.75|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 11||1.75|1.01|
70920970|NCT05119855|141333036|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.36|||||TWO_SIDED|95.0|1.02|1.82|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 16||1.82|1.02|
70920971|NCT05119855|141333036|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.25|||||TWO_SIDED|95.0|0.92|1.7|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 18||1.70|0.92|
70920972|NCT05119855|141333036|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.21|||||TWO_SIDED|95.0|0.91|1.61|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 31||1.61|0.91|
70920973|NCT05119855|141333036|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.32|||||TWO_SIDED|95.0|0.98|1.77|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 33||1.77|0.98|
70920974|NCT05119855|141333036|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.4|||||TWO_SIDED|95.0|1.01|1.93|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 45||1.93|1.01|
70920975|NCT05119855|141333036|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.45|||||TWO_SIDED|95.0|1.13|1.87|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 52||1.87|1.13|
71154115|NCT03069352|141800770|SUPERIORITY||Hazard Ratio (HR)|0.583||||0.002|TWO_SIDED|95.0|0.416|0.817|||Log Rank|Log-rank test stratified by AML status (de novo, secondary) and age (18 - \< 75, ≥ 75).|The hazard ratio was estimated using the Cox proportional hazards model, stratified by AML status (de novo, secondary) and age (18 - \< 75, ≥ 75).|||0.817|0.416|0.002
71154116|NCT03069352|141800770|SUPERIORITY||Hazard Ratio (HR)|0.601||||0.003|TWO_SIDED|95.0|0.43|0.839|||Log Rank|Unstratified analysis|The hazard ratio was estimated using the Cox proportional hazards model.|||0.839|0.430|0.003
70973710|NCT03889639|141454134|SUPERIORITY|Relative reduction in lesions in SAR442168 5 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|-62.16||||0.1525|TWO_SIDED|95.0|-214.44|16.38|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 5 mg/Placebo||16.38|-214.44|0.1525
70973711|NCT03889639|141454134|SUPERIORITY|Relative reduction in lesions in SAR442168 15 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|-47.38||||0.4606|TWO_SIDED|95.0|-312.91|47.4|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 15 mg/Placebo||47.40|-312.91|0.4606
70973712|NCT03889639|141454134|SUPERIORITY|Relative reduction in lesions in SAR442168 30 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|2.9||||0.949|TWO_SIDED|95.0|-138.96|60.54|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 30 mg/Placebo||60.54|-138.96|0.9490
70973713|NCT03889639|141454134|SUPERIORITY|Relative reduction in lesions in SAR442168 60 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|65.05||||0.2324|TWO_SIDED|95.0|-96.21|93.77|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 60 mg/Placebo||93.77|-96.21|0.2324
70973714|NCT03506295|141454141|OTHER||Odds Ratio (OR)|0.496||||0.7878|TWO_SIDED|95.0|0.168|1.469|||Regression, Logistic|||||1.469|0.168|0.7878
70973715|NCT02340663|141454146|OTHER|||||||0.23|||||||t-test, 2 sided|||||||0.23
71032776|NCT00473330|141574820|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|24.4|||<|0.0001|TWO_SIDED|95.0|13.4|35.4||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||35.4|13.4|<0.0001
71032777|NCT00473330|141574820|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|25.1|||<|0.0001|TWO_SIDED|95.0|14.0|36.3||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||36.3|14.0|<0.0001
71032778|NCT00473330|141574821|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|8.2||||0.0086|TWO_SIDED|95.0|2.4|14.1||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||14.1|2.4|0.0086
71045606|NCT02697773|141599468|SUPERIORITY|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.24||0.0002|TWO_SIDED|95.0|-1.37|-0.42||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.42|-1.37|0.0002
70973716|NCT02340663|141454147|OTHER|||||||0.045|||||||ANOVA|||||||0.045
70973717|NCT02340663|141454148|OTHER|||||||0.665|||||||t-test, 2 sided|||||||0.665
70973718|NCT02340663|141454149|OTHER|||||||0.249|||||||Wilcoxon (Mann-Whitney)|||||||0.249
70973719|NCT02340663|141454150|OTHER|||||||0.626|||||||Wilcoxon (Mann-Whitney)|||||||0.626
71032779|NCT00473330|141574821|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|7.8||||0.0126|TWO_SIDED|95.0|2.0|13.6||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||13.6|2.0|0.0126
71032780|NCT00473330|141574822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7||||0.0005|TWO_SIDED|95.0|4.3|15.1||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||15.1|4.3|0.0005
71032781|NCT00473330|141574822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.2||||0.0011|TWO_SIDED|95.0|3.3|13.0||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||13.0|3.3|0.0011
71032782|NCT00473330|141574823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-107.9|||<|0.0001|TWO_SIDED|95.0|-149.2|-66.6||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANCOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||-66.6|-149.2|<0.0001
71032783|NCT00473330|141574823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-119.1|||<|0.0001|TWO_SIDED|95.0|-159.6|-78.5||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANCOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||-78.5|-159.6|<0.0001
71032784|NCT00473330|141574824|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|-3.0||||0.159|TWO_SIDED|95.0|-6.7|0.7||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||0.7|-6.7|0.1590
71032785|NCT00473330|141574824|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|-2.5||||0.2721|TWO_SIDED|95.0|-6.5|1.4||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||1.4|-6.5|0.2721
71154117|NCT03069352|141800771|SUPERIORITY||Treatment Difference|22.9||||0.001|TWO_SIDED|95.0|10.8|35.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).|Treatment difference = Venetoclax - Placebo|||35.0|10.8|0.001
71154118|NCT03069352|141800771|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71154119|NCT03069352|141800772|SUPERIORITY||Treatment Difference|15.2||||0.04|TWO_SIDED|95.0|1.4|29.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).|Treatment difference = Venetoclax - Placebo|||29.0|1.4|0.040
71154120|NCT03069352|141800772|SUPERIORITY|||||||0.039|||||||Fisher Exact|||||||0.039
71154121|NCT03069352|141800773|SUPERIORITY||Treatment Difference|22.4|||||TWO_SIDED|95.0|9.0|35.8||||||||35.8|9.0|
70920976|NCT05119855|141333036|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.2|||||TWO_SIDED|95.0|0.91|1.58|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 58||1.58|0.91|
70920977|NCT05119855|141333037|OTHER|Geometric Mean Concentration (GMC) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-SARS-CoV-2 concentrations and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMC Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Concentration (GMC) Ratio|1.17|||||TWO_SIDED|95.0|0.99|1.4|||||GMC Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Concentration (GMC) Ratio||1.40|0.99|
70920978|NCT02932579|141333044|SUPERIORITY||Mean Difference (Final Values)|13.0||||0.098|TWO_SIDED||||||t-test, 2 sided|||||||0.098
70920979|NCT02932579|141333045|SUPERIORITY||Risk Ratio (RR)|1.38||||0.74|TWO_SIDED|95.0|0.45|4.21|||Fisher Exact|||||4.21|0.45|0.740
70920980|NCT01000480|141333072|SUPERIORITY_OR_OTHER|||||||0.0645||95.0||||P-value for H0 which compared the investigational regimen to historical data.|maximum likelihood estimate|||Null hypothesis (H0): 1-year PFS ≤45% and the alternative hypothesis (H1): 1-year PFS ≥60%, at a 2-sided alpha level of 5%, assuming that PFS time followed an exponential distribution.||||0.0645
70920981|NCT00174382|141333078|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.44|STANDARD_ERROR_OF_MEAN|0.33||0.182||95.0|-0.21|1.09||Baseline value, center, and week as fixed effects; subject was included as a random effect.|Mixed Models Analysis|||Week 12 Null hypothesis; change from baseline to the final visit = 0. Alternative hypothesis; change from baseline to final visit not = to 0. Sample of 260 participants was required for study to have 85% power to detect change from baseline to final visit of 0.73 in SMMSE total score, with a SD of 3.5. Fewer than 260 patients were enrolled, due to this loss in power the number of analyses specified in the protocol has been reduced and any analyses carried out will be exploratory in nature.||1.09|-0.21|0.182
70920982|NCT00174382|141333078|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.66|STANDARD_ERROR_OF_MEAN|0.36||0.067||95.0|-0.05|1.36|||Mixed Models Analysis|||Week 24 Null hypothesis; change from baseline to the final visit = 0. Alternative hypothesis; change from baseline to final visit not = to 0. Sample of 260 participants was required for study to have 85% power to detect change from baseline to final visit of 0.73 in SMMSE total score, with a SD of 3.5. Fewer than 260 patients were enrolled, due to this loss in power the number of analyses specified in the protocol has been reduced and any analyses carried out will be exploratory in nature.||1.36|-0.05|0.067
70920983|NCT00174382|141333078|SUPERIORITY_OR_OTHER|||||||0.085||95.0|||||Mixed Models Analysis|||Week 24 LOCF Null hypothesis; change from baseline to the final visit = 0. Alternative hypothesis; change from baseline to final visit not = to 0. Sample of 260 participants was required for study to have 85% power to detect change from baseline to final visit of 0.73 in SMMSE total score, with a SD of 3.5. Fewer than 260 patients were enrolled, due to this loss in power the number of analyses specified in the protocol has been reduced and any analyses carried out will be exploratory in nature.||||0.085
70973720|NCT02340663|141454151|OTHER|||||||0.695|||||||t-test, 2 sided|||||||0.695
70973721|NCT02340663|141454152|OTHER|||||||0.255|||||||Wilcoxon (Mann-Whitney)|||||||0.255
70973722|NCT02340663|141454153|OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|||||||.049
70973723|NCT02340663|141454156|OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.750
70973724|NCT02340663|141454157|OTHER||||||<|0.01||||||The P-value given is the computed value|Mixed Models Analysis|||||||<0.01
70973725|NCT02340663|141454158|OTHER|||||||0.544|||||||Wilcoxon (Mann-Whitney)|||||||0.544
70973726|NCT02340663|141454159|OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.220
70973727|NCT02340663|141454160|OTHER|||||||0.081|||||||Wilcoxon (Mann-Whitney)|||||||0.081
70973728|NCT02340663|141454161|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
70973729|NCT02340663|141454162|OTHER|||||||0.731|||||||Wilcoxon (Mann-Whitney)|||||||0.731
70973730|NCT02340663|141454163|OTHER|||||||0.238|||||||Wilcoxon (Mann-Whitney)|||||||0.238
70973731|NCT02340663|141454164|OTHER|||||||0.952||||||"The P-value refers to the difference in group means, see Group Means row in the table."|ANOVA|||||||0.952
70973732|NCT02340663|141454165|OTHER|||||||0.53||||||"The P-value refers to the difference in group means, see Group Means row in the table."|ANOVA|||||||0.53
70973733|NCT02340663|141454166|OTHER|||||||0.292||||||"The P-value refers to the difference in group means, see Group Means row in the table."|Mixed Models Analysis|||||||0.292
70973734|NCT02340663|141454167|OTHER|||||||0.289|||||||Wilcoxon (Mann-Whitney)|||The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.||||0.289
70973735|NCT02340663|141454168|OTHER|||||||0.287||||||The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.|Wilcoxon (Mann-Whitney)|||||||0.287
70973736|NCT02340663|141454169|OTHER|||||||0.505||||||The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.|Wilcoxon (Mann-Whitney)|||||||0.505
70973737|NCT02340663|141454170|OTHER|||||||0.643||||||The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.|Wilcoxon (Mann-Whitney)|||||||0.643
70973738|NCT02340663|141454171|OTHER|||||||0.923||||||The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.|Wilcoxon (Mann-Whitney)|||||||0.923
70973739|NCT03694925|141454179|OTHER||Specificity|0.871|||||TWO_SIDED||||||||Specificity was calculated using 2x2 tables using \>14 mg/L cut off. The numerator is the number of the true negatives and the denominator is the number of total negatives.|||||
70973740|NCT03694925|141454179|OTHER||Specificity|0.957|||||TWO_SIDED||||||||Specificity was calculated using 2x2 tables using \>50 mg/L cut off. The numerator is the number of the true negatives and the denominator is the number of total negatives.|||||
71094994|NCT06377488|141698092|SUPERIORITY||least-square mean estimate|-0.085|STANDARD_ERROR_OF_MEAN|0.0139|||TWO_SIDED|95.0|-0.115|-0.056|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Visual Acuity scores at distance was estimated using 95% confidence intervals (CI) constructed for the least-square mean (LSM).|It was calculated using a 1-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 9, 6 and 29 subjects were required to test the primary hypotheses for distance, intermediate and near, respectively.||-0.056|-0.115|
70973741|NCT03694925|141454179|OTHER||Sensitivity|0.981|||||TWO_SIDED||||||||Sensitivity was calculated using 2x2 tables using \>14 mg/L cut off. Sensitivity is the number of true positives over the number of total positives.|||||
70973742|NCT03694925|141454179|OTHER||Sensitivity|0.981|||||TWO_SIDED||||||||Sensitivity was calculated using 2x2 tables using \>50 mg/L cut off. Sensitivity is the number of true positives over the number of total positives.|||||
70973743|NCT03694925|141454179|OTHER||Positive predictive value|0.852|||||TWO_SIDED||||||||Positive predictive value was calculated using 2x2 tables using \>14 mg/L cut off. The numerator is the septic positives and the denominator are the total positives.|||||
70973744|NCT03694925|141454179|OTHER||Positive predictive value|0.945|||||TWO_SIDED||||||||Positive predictive value was calculated using 2x2 tables using \>50mg/L cut off. The numerator is the septic positives and the denominator are the total positives.|||||
70973745|NCT03694925|141454179|OTHER||Negative predictive value|0.984|||||TWO_SIDED||||||||Negative predictive value was calculated using 2x2 tables using \>14 mg/L cut off. The numerator is the aseptic negatives and the denominator is the number of total negatives.|||||
70973746|NCT03694925|141454179|OTHER||Negative predictive value|0.985|||||TWO_SIDED||||||||Negative predictive value was calculated using 2x2 tables using \>50 mg/L cut off. The numerator is the aseptic negatives and the denominator is the number of total negatives.|||||
70973747|NCT03694925|141454180|OTHER||Specificity|0.829|||||TWO_SIDED||||||||Specificity was calculated using 2x2 tables using \>14 mg/L cut off. The numerator is the number of the number of aseptic negatives and the denominator is the number of aseptics.|||||
71032786|NCT00473330|141574825|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|29.5|||<|0.0001|TWO_SIDED|95.0|21.1|38.0||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||38.0|21.1|<0.0001
71032787|NCT00473330|141574825|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|24.2|||<|0.0001|TWO_SIDED|95.0|16.7|31.7||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||31.7|16.7|<0.0001
71094995|NCT06377488|141698092|SUPERIORITY||least-square mean estimate|-0.023|STANDARD_ERROR_OF_MEAN|0.0131|||TWO_SIDED|95.0|-0.05|0.005|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Visual Acuity scores at intermediate was estimated using 95% confidence intervals (CI) constructed for the least-square mean (LSM).|It was calculated using a 1-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 9, 6 and 29 subjects were required to test the primary hypotheses for distance, intermediate and near, respectively.||0.005|-0.050|
71154122|NCT03069352|141800774|SUPERIORITY||Slope|17.7|||||TWO_SIDED|95.0|-0.4|35.8||||||||35.8|-0.4|
71154123|NCT03069352|141800775|SUPERIORITY|||||||0.162|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||0.162
70973748|NCT03694925|141454180|OTHER||Specificity|0.957|||||TWO_SIDED||||||||Specificity was calculated using 2x2 tables using \>50 mg/L cut off. The numerator is the number of the number of aseptic negatives and the denominator is the number of aseptics.|||||
70973749|NCT03694925|141454180|OTHER||Sensitivity|0.981|||||TWO_SIDED||||||||Sensitivity was calculated using 2x2 tables using \>14 mg/L cut off. Sensitivity is the number of septic positives over the number of septics.|||||
70973750|NCT03694925|141454180|OTHER||Sensitivity|0.981|||||TWO_SIDED||||||||Sensitivity was calculated using 2x2 tables using \>50 mg/L cut off. Sensitivity is the number of septic positives over the number of septics.|||||
70973751|NCT03694925|141454180|OTHER||Positive predictive value|0.813|||||TWO_SIDED||||||||Positive predictive value was calculated using 2x2 tables using \>14 mg/L cut off. The numerator is the septic positives and the denominator are the total positives.|||||
70973752|NCT03694925|141454180|OTHER||Positive predictive value|0.945|||||TWO_SIDED||||||||Positive predictive value was calculated using 2x2 tables using \>50mg/L cut off. The numerator is the septic positives and the denominator are the total positives.|||||
70973753|NCT03694925|141454180|OTHER||Negative predictive value|0.983|||||TWO_SIDED||||||||Negative predictive value was calculated using 2x2 tables using \>14 mg/L cut off. The numerator is the aseptic negatives and the denominator is the number of total negatives.|||||
70973754|NCT03694925|141454180|OTHER||Negative predictive value|0.985|||||TWO_SIDED||||||||Negative predictive value was calculated using 2x2 tables using \>50 mg/L cut off. The numerator is the aseptic negatives and the denominator is the number of total negatives.||Negative predictive value was calculated using 2x2 tables using \>50 mg/L cut off. NPV=98.5%|||
70973755|NCT01639872|141454182|SUPERIORITY||difference in treatment means|0.014|STANDARD_ERROR_OF_MEAN|1.62||0.99|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.|||||.99
70973756|NCT01639872|141454183|SUPERIORITY||difference in treatment means|-0.32|STANDARD_ERROR_OF_MEAN|0.28||0.25|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.|||||.25
71154124|NCT03069352|141800775|SUPERIORITY|||||||0.277|||||||Fisher Exact|||||||0.277
70973757|NCT02799069|141454184|NON_INFERIORITY|The sample size of 210 subjects per treatment arm (per protocol set) has a power of at least 90% to establish non-inferiority of BF-200 ALA to Metvix using a non-inferiority margin of -15% and assuming response rates of 70% for both BF-200 ALA and Metvix. The power calculation was based on a one-sided Z-test with continuity correction (unpooled) with a significance level of 0.025.The establishment of non-inferiority was performed for the PP set and verified for robustness on the ITT.|Difference to BF-200 ALA|14.0|||||ONE_SIDED|97.5|5.9||||||||||5.9|
70973758|NCT02799069|141454184|SUPERIORITY||Difference to BF-200 ALA|61.1||||0|TWO_SIDED|95.0|51.2|71.0|||Chi-squared|||"Superiority of BF-200 ALA compared to placebo:~A sample size of 264: 88 patients (BF-200 ALA: placebo) will have a power of more than 90% to establish superiority of BF-200 ALA over placebo, even if very conservative response rates of 65% for the BF-200 ALA group and 40% for placebo are assumed using a chi-square test with continuity correction and a two-sided significance level of 0.05."||71.0|51.2|0.0000
70973759|NCT02799069|141454185|NON_INFERIORITY|The sample size of 210 subjects per treatment arm (per protocol set) has a power of at least 90% to establish non-inferiority of BF-200 ALA to Metvix using a non-inferiority margin of -15% and assuming response rates of 70% for both BF-200 ALA and Metvix. The power calculation was based on a one-sided Z-test with continuity correction (unpooled) with a significance level of 0.025.The establishment of non-inferiority was performed for the PP set and verified for robustness on the ITT.|Difference to BF-200 ALA|14.2|||||ONE_SIDED|97.5|6.0||||||||||6.0|
70973760|NCT02799069|141454185|SUPERIORITY_OR_OTHER||Difference to BF-200 ALA|59.4||||0|TWO_SIDED|95.0|48.4|70.4|||Chi-squared|||||70.4|48.4|0.0000
70973761|NCT02799069|141454186|SUPERIORITY_OR_OTHER||Difference to BF-200 ALA|72.0||||0|TWO_SIDED|95.0|59.7|84.2|||Chi-squared|||||84.2|59.7|0.0000
70973762|NCT02799069|141454186|SUPERIORITY_OR_OTHER||Difference to BF-200 ALA|17.3|||||ONE_SIDED|97.5|6.6||||||||||6.6|
70973763|NCT03434977|141454270|OTHER||Ratio|0.937|||||TWO_SIDED|90.0|0.89|0.986||||||The shown data were ratio of fed conditions divided by fasted conditions, taking anti-logs of the least square (LS) means difference (fed-fasted) or confidence interval (CI). The difference in LS means between treatment conditions (fed-fasted) and two-sided 90% CI were provided using a crossover analysis of variance (ANOVA) model. ANOVA model included log-transformed (natural log) PK parameters Cmax as dependent variable, and treatment condition, group, and period as independent variables.||0.986|0.890|
71094996|NCT06377488|141698092|SUPERIORITY||least-square mean estimate|0.083|STANDARD_ERROR_OF_MEAN|0.0152|||TWO_SIDED|95.0|0.051|0.116|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Visual Acuity scores at near was estimated using 95% confidence intervals (CI) constructed for the least-square mean (LSM).|It was calculated using a 1-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 9, 6 and 29 subjects were required to test the primary hypotheses for distance, intermediate and near, respectively.||0.116|0.051|
71154125|NCT03069352|141800776|SUPERIORITY|||||||0.162|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||0.162
70973764|NCT03434977|141454271|OTHER||LS-Means Difference|0.9083|||||TWO_SIDED|90.0|0.1821|1.6345||||||The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (non-natural log) PK parameters tmax as dependent variable, and treatment condition, group, and period as independent variables.||1.6345|0.1821|
70973765|NCT03434977|141454272|OTHER||Ratio|0.998|||||TWO_SIDED|90.0|0.943|1.056||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters AUClast as dependent variable, and treatment condition, group, and period as independent variables.||1.056|0.943|
70973766|NCT03434977|141454273|OTHER||Ratio|0.997|||||TWO_SIDED|90.0|0.942|1.056||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters AUC∞ as dependent variable, and treatment condition, group, and period as independent variables.||1.056|0.942|
70973767|NCT03434977|141454274|OTHER||Ratio|0.985|||||TWO_SIDED|90.0|0.932|1.041||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters T1/2z as dependent variable, and treatment condition, group, and period as independent variables.||1.041|0.932|
70973768|NCT03434977|141454275|OTHER||Ratio|1.047|||||TWO_SIDED|90.0|1.006|1.091||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters MRTlast, ev as dependent variable, and treatment condition, group, and period as independent variables.||1.091|1.006|
70973769|NCT03434977|141454276|OTHER||Ratio|1.037|||||TWO_SIDED|90.0|0.996|1.081||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters MRT∞, ev as dependent variable, and treatment condition, group, and period as independent variables.||1.081|0.996|
70973770|NCT03434977|141454277|OTHER||Ratio|1.014|||||TWO_SIDED|90.0|0.959|1.071||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters λz as dependent variable, and treatment condition, group, and period as independent variables.||1.071|0.959|
71154126|NCT03069352|141800776|SUPERIORITY|||||||0.277|||||||Fisher Exact|||||||0.277
71032788|NCT00473330|141574826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.7||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||-0.7|-1.4|<0.0001
71032789|NCT00473330|141574826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.7||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||-0.7|-1.5|<0.0001
71032790|NCT01975948|141574831|OTHER|||||||0.047||||||Adjusted for baseline depressive symptoms and unemployment as covariates (p=.016), and non-completers (missing one or more points of follow up data).|Mixed Models Analysis|||One hundred evaluable patients per arm were needed to achieve 80% power to detect a PHQ-9 between-group difference in mean change of 2 points, significance level (α) .05, a two-sided test, and a standard deviation of 5 points. An intra cluster correlation of 0.05 for patient outcomes was used (Murphey et al), and an average cluster size: 3 patients/practice resulted in compensatory increase to 110 patients per arm. Under the assumption that attrition would be 33 % we needed 166 patients per arm.||||.047
71032791|NCT01975948|141574832|OTHER|||||||0.15|||||||Mixed Models Analysis|||Our calculations indicated that 50 physicians in each of the two groups will provide \>80% power to detect clinically significant reductions in stigma as assessed by OMS-HC change scores. Clinically meaningful was defined as a change of 3 points, derived on the basis of this being slightly better than what is usually seen in brief interventions.||||0.15
71032792|NCT01975948|141574832|OTHER||Cohen'd|0.45||||0.03|TWO_SIDED|||||OMS-HC analysis adjusted for practice size: P value applies to between group physicians reduction in one stigma domaine: preference for social distance|Mixed Models Analysis|||Between Group Changes in subscale of the Opening Minds Scale for Health Care Providers (OMS-HC) measures three different dimensions of stigma: attitudes towards people with a mental illness (6 items); health care professionals' attitudes about disclosure of a mental illness/willingness to seek help for a mental illness (4 items), and preference for social distance (5 items). Items are rated on a 5-point scale. Mean scores can range from one to five with lower scores indicating less stigma.||||.03
71032793|NCT01975948|141574833|OTHER|||||||0.993|||||||Mixed Models Analysis|||||||.993
71032794|NCT01975948|141574834|OTHER||Cohen'd|1.48|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<.001
71032795|NCT01975948|141574834|OTHER|||||||0.03|||||||Generalized estimating equations (GEE)|We used the slope of a regression line fit using generalized estimating equations (GEE) with an exchangeable correlation structure.||Correlation between increases in Physician Comfort and Confidence in managing mental illness and Stigma Score.||||.03
71032796|NCT01975948|141574835|OTHER||Cohen'd|1.44|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<.001
71094997|NCT06377488|141698093|SUPERIORITY||Mean Population Estimate|62.1|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|95.0|56.7|67.5|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Mean estimates were conducted for myopes only using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a 1-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 23 and 29 subjects were required to test for superiority for CLUE vision scores for hyperopes and myopes, respectively.||67.5|56.7|
71032797|NCT01975948|141574835|SUPERIORITY|||||||0.476||||||We used the slope of a regression line fit using generalized estimating equations (GEE) with an exchangeable correlation structure.|Generalized estimating equations (GEE)|||Correlation between increases in Physician Comfort and Confidence with non-program specific tools and Stigma Score.||||.476
71094998|NCT06377488|141698093|SUPERIORITY||Mean Population Estimate|57.8|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|51.7|64.0|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Mean estimates were conducted for hyperopes only using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a 1-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 23 and 29 subjects were required to test for superiority for CLUE vision scores for hyperopes and myopes, respectively.||64.0|51.7|
71094999|NCT06377488|141698094|SUPERIORITY||Central Posterior Mean Estimate|0.943|STANDARD_DEVIATION|0.0155|||TWO_SIDED|95.0|0.908|0.968|||Bayesian beta-binomial model|Bayesian beta-binomial model with correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.902 and an intraclass correlation of 0.70, that 140 subjects were required to test for superiority to achieve a minimum statistical power of 96% with 95% central posterior credible interval.||0.968|0.908|
70920984|NCT00174382|141333079|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|STANDARD_ERROR_OF_MEAN|1.16||0.218||95.0|-1.2|5.19|||Mixed Models Analysis|||||5.19|-1.20|0.218
70920985|NCT00174382|141333079|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.85|STANDARD_ERROR_OF_MEAN|2.12||0.385||95.0|-6.03|2.34|||Mixed Models Analysis|||||2.34|-6.03|0.385
71032798|NCT01975948|141574836|SUPERIORITY||Cohen'd|3.25|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<.001
71032799|NCT01975948|141574836|SUPERIORITY|||||||0.945||||||We used the Spearman's correlation coefficient using the slope of a regression line fit using generalized estimating equations (GEE) with an exchangeable correlation structure.|Generalized estimating equations (GEE)|||Correlation between increases in Physician Comfort and Confidence with program specific tools and Stigma Score.||||.945
70920986|NCT00174382|141333079|SUPERIORITY_OR_OTHER|||||||0.228||95.0|||||Mixed Models Analysis|||||||0.228
70920987|NCT00174382|141333080|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.84|STANDARD_ERROR_OF_MEAN|2.19||0.404||95.0|-2.51|6.18|||Mixed Models Analysis|||||6.18|-2.51|0.404
70920988|NCT00174382|141333080|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.57|STANDARD_ERROR_OF_MEAN|2.56||0.826||95.0|-4.51|5.64|||Mixed Models Analysis|||||5.64|-4.51|0.826
71032800|NCT01975948|141574837|OTHER|||||||0.742|||||||Mixed Models Analysis|||||||.742
71032801|NCT01975948|141574838|OTHER|||||||0.543|||||||Mixed Models Analysis|||||||.543
70920989|NCT00174382|141333080|SUPERIORITY_OR_OTHER|||||||0.494||95.0|||||Mixed Models Analysis|||||||0.494
70920990|NCT00174382|141333081|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.78|STANDARD_ERROR_OF_MEAN|1.61||0.272||95.0|-1.42|4.99|||Mixed Models Analysis|||||4.99|-1.42|0.272
70920991|NCT00174382|141333081|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|2.0||0.894||95.0|-4.21|3.68|||Mixed Models Analysis|||||3.68|-4.21|0.894
70920992|NCT00174382|141333081|SUPERIORITY_OR_OTHER|||||||0.906||95.0|||||Mixed Models Analysis|||||||0.906
70920993|NCT00174382|141333082|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.35||0.719||95.0|-0.56|0.82|||Mixed Models Analysis|||||0.82|-0.56|0.719
70920994|NCT00174382|141333082|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|0.36||0.006||95.0|0.29|1.71|||Mixed Models Analysis|||||1.71|0.29|0.006
70920995|NCT00174382|141333082|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Mixed Models Analysis|||||||0.007
70920996|NCT00174382|141333083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.32|STANDARD_ERROR_OF_MEAN|0.35||0.368||95.0|-0.38|1.01|||Mixed Models Analysis|||||1.01|-0.38|0.368
70920997|NCT00174382|141333083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.72|STANDARD_ERROR_OF_MEAN|0.33||0.03||95.0|0.07|1.37|||Mixed Models Analysis|||||1.37|0.07|0.030
70920998|NCT00174382|141333083|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Mixed Models Analysis|||||||0.060
71032802|NCT01975948|141574839|OTHER|||||||0.009|||||||Mixed Models Analysis|||||||.009
71032803|NCT01975948|141574840|OTHER|||||||0.213|||||||Mixed Models Analysis|||||||.213
71032804|NCT02834663|141574846|SUPERIORITY||Mean Difference (Final Values)|-8.76|STANDARD_DEVIATION|12.521|<|0.0001|TWO_SIDED|95.0|-13.928|-3.592||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||Patients were evaluated for changes in BCVA of the treated eye, from the start of the study till 6 months, until trial completion. After administration of each injection, measurements of BCVA were compared to their respective baseline results. The paired t-test and repeated measures ANOVA was performed for comparative analysis, as all showed normality.||-3.592|-13.928|<0.0001
71032805|NCT02834663|141574847|SUPERIORITY||Mean Difference (Final Values)|110.0|STANDARD_DEVIATION|65.919||0.0001|TWO_SIDED|95.0|82.79|137.21||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||137.210|82.790|0.0001
71032806|NCT02834663|141574848|SUPERIORITY||Mean Difference (Final Values)|3.92|STANDARD_DEVIATION|4.932||0.001|TWO_SIDED|95.0|1.884|5.956||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||5.956|1.884|0.001
71032807|NCT02834663|141574849|SUPERIORITY||Mean Difference (Final Values)|2.23|STANDARD_DEVIATION|2.24||0.0001|TWO_SIDED|95.0|1.3|3.15||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||3.15|1.30|0.0001
71032808|NCT02834663|141574850|SUPERIORITY||Mean Difference (Final Values)|5.64|STANDARD_DEVIATION|7.21||0.0001|TWO_SIDED|95.0|2.67|8.62||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||8.62|2.67|0.0001
71032809|NCT02834663|141574851|SUPERIORITY||Mean Difference (Final Values)|5.64|STANDARD_DEVIATION|7.21||0.0001|TWO_SIDED|95.0|2.67|8.62||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||8.62|2.67|0.0001
71032810|NCT02834663|141574852|SUPERIORITY||Mean Difference (Final Values)|0.021|STANDARD_DEVIATION|1.87||0.221|TWO_SIDED|95.0|-0.751|0.795||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||0.795|-0.751|0.221
71032811|NCT01723397|141574856|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon signed-rank test|||||||0.8
71032812|NCT02009163|141574871|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value based on a log-rank test, stratified by 4-week cessation status (Yes, No). 4-week cessation was defined as a subject having no binge days during the 4 weeks prior to randomization.|Log Rank|||||||<0.001
71032813|NCT02009163|141574872|SUPERIORITY_OR_OTHER_LEGACY||difference in LS mean|-0.61|||<|0.001|TWO_SIDED|95.0|-0.81|-0.42||Nominal P-value not adjusted for multiplicity.|mixed- effects model for repeated measur|MMRM over all post-randomization visits during the randomized-withdrawal phase. Value for change from baseline = outcome variable.||||-0.42|-0.81|<0.001
71032814|NCT02009163|141574873|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Unadjusted P-value for the difference in distribution between treatment groups in CGI-S.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with a modified ridit score, adjusting for Visit 8 (Week 12) CGI-S as the covariate.||||||<0.001
71032815|NCT02009163|141574874|SUPERIORITY_OR_OTHER_LEGACY||difference in LS mean|-5.6|||<|0.001|TWO_SIDED|95.0|-7.2|-3.9||Nominal P-value not adjusted for multiplicity.|mixed-effects model for repeated measure|MMRM over all post-randomization visits during the randomized-withdrawal phase. Value for change from baseline = outcome variable.||||-3.9|-7.2|<0.001
71032816|NCT00833586|141574894|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|95.1||||||90.0|85.8|105.4|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.4|85.8|
71032817|NCT00833586|141574895|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|98.9||||||90.0|82.7|118.4|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||118.4|82.7|
71032818|NCT00833586|141574896|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|102.4||||||90.0|95.0|110.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||110.5|95.0|
71032819|NCT01304641|141574897|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71032820|NCT01304641|141574898|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.078||||0.14|TWO_SIDED|95.0|0.976|1.192|||Regression, Cox|||||1.192|0.976|0.140
71032821|NCT01304641|141574899|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
70920999|NCT00174382|141333084|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.33||0.516||95.0|-0.44|0.86|||Mixed Models Analysis|||||0.86|-0.44|0.516
70921000|NCT00174382|141333084|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|0.32||0.297||95.0|-0.97|0.3|||Mixed Models Analysis|||||0.30|-0.97|0.297
70921001|NCT00174382|141333084|SUPERIORITY_OR_OTHER|||||||0.133||95.0|||||Mixed Models Analysis|||||||0.133
70921002|NCT00174382|141333085|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.79|STANDARD_ERROR_OF_MEAN|0.33||0.02||95.0|0.13|1.45|||Mixed Models Analysis|||||1.45|0.13|0.020
70921003|NCT00174382|141333085|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.87|STANDARD_ERROR_OF_MEAN|0.36||0.018||95.0|0.16|1.59|||Mixed Models Analysis|||||1.59|0.16|0.018
70921004|NCT00174382|141333085|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Mixed Models Analysis|||||||0.004
70921005|NCT00174382|141333086|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|0.42||0.01||95.0|-1.93|-0.27|||Mixed Models Analysis|||||-0.27|-1.93|0.010
70921006|NCT00174382|141333086|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.12|STANDARD_ERROR_OF_MEAN|0.47||0.018||95.0|-2.05|-0.19|||Mixed Models Analysis|||||-0.19|-2.05|0.018
70921007|NCT00174382|141333086|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||Mixed Models Analysis|||||||0.018
70921008|NCT00174382|141333087|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.83|STANDARD_ERROR_OF_MEAN|0.62||0.182||95.0|-2.06|0.39|||Mixed Models Analysis|||||0.39|-2.06|0.182
70921009|NCT00174382|141333087|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09|STANDARD_ERROR_OF_MEAN|0.68||0.114||95.0|-2.44|0.26|||Mixed Models Analysis|||||0.26|-2.44|0.114
70921010|NCT00174382|141333087|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||Mixed Models Analysis|||||||0.038
70921011|NCT00296036|141333092|SUPERIORITY_OR_OTHER|||||||0.768|||||||Fisher Exact|||||||0.768
70921012|NCT02576509|141333100|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0752|TWO_SIDED|95.0|0.71|1.02||A priori threshold for statistical significance is 0.0419|Log Rank|Log-rank Test stratified by the stratification factors as entered into the IVRS|Nivolumab over Sorafenib; Stratified Cox proportional hazard model||95.81% CI ADJUSTED FOR MULTIPLICITY: (0.72 to 1.02)|1.02|0.71|0.0752
70921013|NCT02576509|141333101|OTHER|no test was performed due to OS p-value result above the prior threshold|Difference of ORRs|8.3|||||TWO_SIDED|95.0|3.9|12.7|||||Estimate of (Nivolumab - Sorafenib) is based on CMH method of weighting, stratified by stratification factors|||12.7|3.9|
70921014|NCT02576509|141333101|OTHER|no test was performed due to OS p-value result above the prior threshold|Odds Ratio (OR)|2.41|||||TWO_SIDED|95.0|1.48|3.92|||||Nivolumab over Sorafenib; Mantel-Haenszel estimator|||3.92|1.48|
70921015|NCT02576509|141333102|OTHER|no test was performed due to OS p-value result above the prior threshold|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.79|1.1|||||Nivolumab over Sorafenib; Stratified Cox proportional hazard model|||1.10|0.79|
70921016|NCT02576509|141333103|OTHER|PD-L1 \>= 1%, OS; no test was performed|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.54|1.19|||||Nivolumab over Sorafenib|||1.19|0.54|
70921017|NCT02576509|141333103|OTHER|PD-L1 \>=1%, PFS; no test was performed|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.48|1.03|||||Nivolumab over Sorafenib|||1.03|0.48|
70921018|NCT02576509|141333103|OTHER|PD-L1 \<1%, OS; no test was performed|Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.69|1.02|||||Nivolumab over Sorafenib|||1.02|0.69|
70921019|NCT02576509|141333103|OTHER|PD-L1 \<1%, PFS; no test was performed|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.81|1.17|||||Nivolumab over Sorafenib|||1.17|0.81|
70921020|NCT02576509|141333103|OTHER|without PD-L1 quantifiable, OS; no test was performed|Hazard Ratio (HR)|1.26|||||TWO_SIDED|95.0|0.34|4.74|||||Nivolumab over Sorafenib|||4.74|0.34|
70921021|NCT02576509|141333103|OTHER|without PD-L1 quantifiable, PFS; no test was performed|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.27|3.52|||||Nivolumab over Sorafenib|||3.52|0.27|
70921022|NCT02576509|141333104|OTHER|PD-L1 \>=1%, ORR; no test was performed|Odds Ratio (OR)|3.79|||||TWO_SIDED|95.0|1.41|10.17|||||Odds ratio (Nivolumab over Sorafenib) and associated unstratified 95% exact CI.|||10.17|1.41|
71032822|NCT01304641|141574900|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71032823|NCT01304641|141574901|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
70921023|NCT02576509|141333104|OTHER|PD-L1 \<1%, ORR; no test was performed|Odds Ratio (OR)|1.95|||||TWO_SIDED|95.0|1.1|3.45|||||Odds ratio (Nivolumab over Sorafenib) and associated unstratified 95% exact CI|||3.45|1.10|
70921024|NCT03089125|141333159|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.038|TWO_SIDED|95.0|-0.61|-0.05||Bonferroni-adjusted P-value|ANCOVA|ANCOVA models control for cancer type, study site, and baseline scores of outcome variable.||||-0.05|-0.61|0.038
70921025|NCT03089125|141333160|SUPERIORITY||Mean Difference (Final Values)|-0.55|||>|0.99|TWO_SIDED|95.0|-2.2|1.1||Bonferroni-adjusted P-value|ANCOVA|ANCOVA models control for cancer type, study site, and baseline scores of outcome variable.||||1.10|-2.20|>0.99
70921026|NCT03089125|141333161|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.38|TWO_SIDED|95.0|-1.98|5.18|||ANCOVA|ANCOVA models control for cancer type, study site, and baseline scores of outcome variable.||||5.18|-1.98|0.380
70921027|NCT03089125|141333162|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.99|TWO_SIDED|95.0|-0.83|0.82|||ANCOVA|ANCOVA models control for cancer type, study site, and baseline scores of outcome variable.||||0.82|-0.83|0.990
70921028|NCT03089125|141333163|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.251|TWO_SIDED|95.0|-1.34|0.35|||ANCOVA|||||0.35|-1.34|0.251
71032824|NCT01304641|141574902|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71032825|NCT01304641|141574903|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71032826|NCT04544787|141574904|OTHER|||||||0.7209|||||||Fisher Exact|||The number of participants with severe solicited adverse events in the OPV-vaccinated groups who received nOPV-c1 (combined Groups 1 and 2) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with severe solicited adverse events was 5 out of 100.||||0.7209
71032827|NCT04544787|141574904|OTHER|||||||0.7209|||||||Fisher Exact|||The number of participants with severe solicited adverse events in the OPV-vaccinated groups who received nOPV-c2 (combined Groups 3 and 4) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with severe solicited adverse events was 5 out of 100.||||0.7209
71095000|NCT06377488|141698095|SUPERIORITY||Central Posterior Mean Estimate|0.988|STANDARD_DEVIATION|0.0058|||TWO_SIDED|95.0|0.974|0.997|||Bayesian beta-binomial model|Bayesian beta-binomial model with correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.99 and an intraclass correlation of 0.70, that 140 subjects were required to test for superiority to achieve a minimum statistical power of 96% with 95% central posterior credible interval.||0.997|0.974|
71095001|NCT06377488|141698096|SUPERIORITY||Central Posterior Mean Estimate|0.006|STANDARD_DEVIATION|0.0047|||TWO_SIDED|95.0|0.0|0.017|||Bayesian beta-binomial model|Bayesian beta-binomial model with correlated binary data||It was calculated that 140 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible.||0.017|0.000|
71095002|NCT06377488|141698097|SUPERIORITY||Central Posterior Mean Estimate|0.003|STANDARD_DEVIATION|0.0029|||TWO_SIDED|95.0|0.0|0.011|||Bayesian beta-binomial model|Bayesian beta-binomial model with correlated binary data||It was calculated that 140 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible.||0.011|0.000|
71095003|NCT06377488|141698098|SUPERIORITY||Least-square mean estimate|57.8|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|51.7|64.0|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|This is the analysis for hyperopes only. Mean estimates were conducted using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a one-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 42 and 55 subjects were required to test for superiority for CLUE vision scores for hyperopes and myopes, respectively.||64.0|51.7|
71095004|NCT06377488|141698098|SUPERIORITY||Least-square mean estimate|62.1|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|95.0|56.7|67.5|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|This is the analysis for myopes only. Mean estimates were conducted using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a one-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 42 and 55 subjects were required to test for superiority for CLUE vision scores for hyperopes and myopes, respectively.||67.5|56.7|
71032828|NCT04544787|141574904|OTHER|||||||0.3769|||||||Fisher Exact|||The number of participants with severe unsolicited adverse events in the OPV-vaccinated groups who received nOPV-c1 (combined Groups 1 and 2) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with severe unsolicited adverse events was 17 out of 100.||||0.3769
71154127|NCT03069352|141800780|OTHER||Hazard Ratio (HR)|0.704||||0.04|TWO_SIDED|95.0|0.503|0.985|||Log Rank|Log-rank test stratified by AML status (de novo, secondary) and age (18 - \< 75, ≥ 75).|The hazard ratio was estimated using the Cox proportional hazards model, stratified by AML status (de novo, secondary) and age (18 - \< 75, ≥ 75).|||0.985|0.503|0.040
71154128|NCT03069352|141800780|OTHER||Hazard Ratio (HR)|0.717||||0.049|TWO_SIDED|95.0|0.514|1.0|||Log Rank|Unstratified analysis|The hazard ratio was estimated using the Cox proportional hazards model.|||1.000|0.514|0.049
70921029|NCT03089125|141333164|SUPERIORITY||Mean Difference (Final Values)|-1.49||||0.647|TWO_SIDED|95.0|-7.9|4.92|||ANCOVA|ANCOVA models control for cancer type, study site, and baseline scores of outcome variable.||||4.92|-7.90|0.647
70921030|NCT03089125|141333165|SUPERIORITY||Mean Difference (Final Values)|1.63||||0.431|TWO_SIDED|95.0|-2.45|5.71||ANCOVA models control for cancer type, study site, and baseline scores of outcome variable.|ANCOVA|||||5.71|-2.45|0.431
70921031|NCT03089125|141333166|SUPERIORITY||Between-group diff in change per 8 weeks|-0.06||||0.71|TWO_SIDED|95.0|-0.38|0.26|||Mixed Models Analysis|Estimated between-group difference in change in scores per every 8 weeks from baseline through week 24, controlling for cancer type and study site.||||0.26|-0.38|0.710
70921032|NCT03089125|141333167|SUPERIORITY||Between-group diff in change per 8 weeks|0.38||||0.677|TWO_SIDED|95.0|-1.4|2.16|||Mixed Models Analysis|Estimated between-group difference in change in scores per every 8 weeks from baseline through week 24, controlling for cancer type and study site.||||2.16|-1.40|0.677
70921033|NCT03089125|141333168|SUPERIORITY||Between-group diff in change per 8 weeks|-1.95||||0.33|TWO_SIDED|95.0|-5.87|1.97|||Mixed Models Analysis|Estimated between-group difference in change in scores per every 8 weeks from baseline through week 24, controlling for cancer type and study site.||||1.97|-5.87|0.330
70921034|NCT03089125|141333169|SUPERIORITY||Between-group diff in change per 8 weeks|0.73||||0.098|TWO_SIDED|95.0|-0.13|1.59|||Mixed Models Analysis|Estimated between-group difference in change in scores per every 8 weeks from baseline through week 24, controlling for cancer type and study site.||||1.59|-0.13|0.098
70921035|NCT03089125|141333170|SUPERIORITY||Between-group diff in change per 8 weeks|0.08||||0.845|TWO_SIDED|95.0|-0.76|0.93|||Mixed Models Analysis|Estimated between-group difference in change in scores per every 8 weeks from baseline through week 24, controlling for cancer type and study site.||||0.93|-0.76|0.845
70921036|NCT03089125|141333171|SUPERIORITY||Between-group diff in change per 8 weeks|0.74||||0.837|TWO_SIDED|95.0|-6.33|7.77|||Mixed Models Analysis|Estimated between-group difference in change in scores per every 8 weeks from baseline through week 24, controlling for cancer type and study site.||||7.77|-6.33|0.837
70921037|NCT02217904|141333225|SUPERIORITY||Posterior mean difference|-1.64|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was \>99%.|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.||||
70973771|NCT03434977|141454278|OTHER||Ratio|1.003|||||TWO_SIDED|90.0|0.947|1.062||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters CL/F as dependent variable, and treatment condition, group, and period as independent variables.||1.062|0.947|
70973772|NCT03434977|141454279|OTHER||Ratio|0.989|||||TWO_SIDED|90.0|0.916|1.068||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters Vz/F as dependent variable, and treatment condition, group, and period as independent variables.||1.068|0.916|
70973773|NCT00217087|141454285|SUPERIORITY_OR_OTHER|||||||0.0098|TWO_SIDED||||||Fisher Exact|||||||0.0098
70973774|NCT00217087|141454286|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Chi-squared|||||||0.34
70973775|NCT00217087|141454287|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Chi-squared|the only participant who reported a decrease quality of life related that to a recent surgery not their esophagus.||||||0.2
71032829|NCT04544787|141574904|OTHER|||||||0.3083|||||||Fisher Exact|||The number of participants with severe unsolicited adverse events in the OPV-vaccinated groups who received nOPV-c2 (combined Groups 3 and 4) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with severe unsolicited adverse events was 17 out of 100.||||0.3083
71032830|NCT04544787|141574904|OTHER|||||||0.4975|||||||Fisher Exact|||The number of participants with serious unsolicited adverse events in the OPV-vaccinated groups who received nOPV-c1 (combined Groups 1 and 2) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with serious unsolicited adverse events was 0 out of 100.||||0.4975
71032831|NCT04544787|141574904|OTHER|||||||1|||||||Fisher Exact|||The number of participants with serious unsolicited adverse events in the OPV-vaccinated groups who received nOPV-c2 (combined Groups 3 and 4) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with serious unsolicited adverse events was 0 out of 100.||||1.0000
71032832|NCT04544787|141574904|OTHER|||||||1|||||||Fisher Exact|||Comparison of severe solicited adverse events||||1.0000
71032833|NCT04544787|141574904|OTHER|||||||1|||||||Fisher Exact|||Comparison of severe solicited adverse events||||1.0000
71032834|NCT04544787|141574904|OTHER|||||||0.1571|||||||Fisher Exact|||Comparison of severe unsolicited adverse events||||0.1571
71032835|NCT04544787|141574904|OTHER|||||||0.296|||||||Fisher Exact|||Comparison of severe unsolicited adverse events||||0.2960
71032836|NCT04544787|141574905|NON_INFERIORITY|The primary immunogenicity endpoint, seroprotection on Day 28 after a single dose of each vaccine candidate, was formally compared with the corresponding endpoint from UAM1 via a non-inferiority test of the difference of each of the novel candidates to the monovalent OPV2 control, mOPV2, each using one-sided α=0.025 and a non-inferiority margin of 10%, computed using two-sided α=0·05 Miettinen and Nurminen score-based CIs for inference.|Difference|2.0|||||TWO_SIDED|95.0|-1.9|7.0||||||The primary immunogenicity endpoint, the seroprotection rate after one dose of either vaccine candidate in the OPV-vaccinated groups (nOPV2 combined groups 1 and 2, and combined groups 3 and 4), was compared with the corresponding endpoint from the historical monovalent OPV2 (mOPV2) control study (UAM1, EudraCT # 2015-003325-33). In the UAM1 study, the observed seroprotection rate after a single dose of mOPV2 was 98% (98 out of 100 participants), with a 95% confidence interval (CI) of 93-100%.||7.0|-1.9|
71032837|NCT04544787|141574905|NON_INFERIORITY|The primary immunogenicity endpoint, seroprotection on Day 28 after a single dose of each vaccine candidate, was formally compared with the corresponding endpoint from UAM1 via a non-inferiority test of the difference of each of the novel candidates to the monovalent OPV2 control, mOPV2, each using one-sided α=0.025 and a non-inferiority margin of 10%, computed using two-sided α=0·05 Miettinen and Nurminen score-based CIs for inference.|Difference|2.0|||||TWO_SIDED|95.0|-1.8|7.0||||||The primary immunogenicity endpoint, the seroprotection rate after one dose of either vaccine candidate in the OPV-vaccinated groups (nOPV2 combined groups 1 and 2, and combined groups 3 and 4), was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33). In the UAM1 study, the observed seroprotection rate after a single dose of mOPV2 was 98% (98 out of 100 participants), with a 95% confidence interval (CI) of 93-100%.||7.0|-1.8|
71032838|NCT03686033|141574934|SUPERIORITY||LS Mean difference|1.12|||||TWO_SIDED|90.0|-0.98|3.22||||||The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (predose) measurement as a covariate, and subject nested within sequence as a random effect. Least Square (LS) Mean Difference was calculated for 2.5 mg versus (vs) Placebo only.||3.22|-0.98|
71032839|NCT03686033|141574934|SUPERIORITY||LS Mean difference|-4.17|||||TWO_SIDED|90.0|-6.35|-1.99||||||The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (predose) measurement as a covariate, and subject nested within sequence as a random effect. LS Mean Difference was calculated for 25 mg vs Placebo only.||-1.99|-6.35|
71032840|NCT01085825|141574994|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Chi-squared|||||||.13
71032841|NCT02444715|141575027|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||t-test, 2 sided|||H0: no change between baseline and post-intervention||||0.96
71032842|NCT02444715|141575027|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||t-test, 2 sided|||H0: no change between baseline and post-intervention||||0.03
71032843|NCT02444715|141575028|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.53
71032844|NCT02444715|141575028|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.44
71032845|NCT02444715|141575029|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.76
71032846|NCT02444715|141575029|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.04
71032847|NCT02444715|141575030|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.39
71032848|NCT02444715|141575030|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.04
71032849|NCT02444715|141575031|SUPERIORITY_OR_OTHER|||||||0.92|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.92
71095005|NCT06377488|141698099|SUPERIORITY||Mean Population Estimate|64.7|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|58.6|70.8|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Mean estimates were conducted for hyperopes using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a one-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 23 and 46 subjects were required to test for superiority for CLUE comfort scores for hyperopes and myopes, respectively.||70.8|58.6|
71095006|NCT06377488|141698099|SUPERIORITY||Mean Population Estimate|64.2|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|95.0|59.0|69.5|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Mean estimates were conducted for myopes using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a one-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 23 and 46 subjects were required to test for superiority for CLUE comfort scores for hyperopes and myopes, respectively.||69.5|59.0|
71095007|NCT06377488|141698100|SUPERIORITY||Mean Population Estimate|67.9|STANDARD_ERROR_OF_MEAN|2.79|||TWO_SIDED|95.0|62.2|73.5|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Mean estimates were conducted for hyperopes using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a one-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 15 and 26 subjects were required to test for superiority for CLUE handling scores for hyperopes and myopes, respectively.||73.5|62.2|
70973776|NCT05574062|141454289|NON_INFERIORITY|-7.5% non-inferiority margin|Mean Difference (Final Values)|9.88|||||TWO_SIDED|95.0|8.04|11.72|||Mixed Models Analysis||Mixed model adjusted for baseline (run-in) values|||11.72|8.04|
70973777|NCT05574062|141454290|NON_INFERIORITY|non-inferiority margin of 0.4% HbA1c|Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-0.03|0.31|||Regression, Linear||Linear regression model adjusted for baseline (continuation phase period1) values|||0.31|-0.03|
70973778|NCT05574062|141454291|NON_INFERIORITY|non- inferiority margin of 0.4%|Mean Difference (Final Values)|-0.61|||||TWO_SIDED|95.0|-0.76|-0.46|||Mixed Models Analysis||Mixed model adjusted for baseline (screening) values|||-0.46|-0.76|
71032850|NCT02444715|141575031|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.37
70973779|NCT05574062|141454292|SUPERIORITY||Median Difference (Final Values)|9.88|||<|0.0001|TWO_SIDED|95.0|8.04|11.72|||Mixed Models Analysis||Mixed model adjusted for baseline (run-in) values|||11.72|8.04|<.0001
70973780|NCT05574062|141454293|SUPERIORITY||Mean Difference (Net)|-0.61|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.46|||Mixed Models Analysis||Mixed model adjusted for baseline (screening) values|||-0.46|-0.76|<.0001
70973781|NCT05574062|141454294|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.1097|TWO_SIDED|95.0|-0.03|0.31|||Regression, Linear||Linear regression model adjusted for baseline (period1) values|||0.31|-0.03|0.1097
70973782|NCT05574062|141454295|NON_INFERIORITY|non inferiority margin of -7.5%|Mean Difference (Net)|1.17|||||TWO_SIDED|95.0|-0.04|2.38|||Regression, Linear||Linear regression adjusted for baseline (continuation phase period 1) values|||2.38|-0.04|
70973783|NCT05574062|141454296|SUPERIORITY||Mean Difference (Final Values)|1.17||||0.0581|TWO_SIDED|95.0|-0.04|2.38|||Regression, Linear||Linear regression adjusted for baseline (continuation phase period 1) values|||2.38|-0.04|0.0581
70973784|NCT00546052|141454299|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|0.74||0.999||95.0|-0.02|0.06|||t-test, 1 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null hypothesis value is + 0.5%.||0.06|-0.02|0.999
70973785|NCT00546052|141454300|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.62||0.999||95.0|0.01|0.07|||t-test, 1 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null hypothesis value is + 0.5mmol/L.||0.07|0.01|0.999
71032851|NCT02444715|141575032|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.78
71032852|NCT02444715|141575032|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.19
71032853|NCT02444715|141575033|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||t-test, 2 sided|||H0: no change between baseline and post-intervention||||0.9
71032854|NCT02444715|141575033|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||t-test, 2 sided|||H0: no change between baseline and post-intervention||||0.43
71032855|NCT02444715|141575034|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.67
71032856|NCT02444715|141575034|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.04
71032857|NCT02444715|141575035|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.26
71032858|NCT02444715|141575035|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.07
71032859|NCT02444715|141575036|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.06
71032860|NCT02444715|141575036|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.04
71032861|NCT02444715|141575037|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"Medium intensity~H0: no change between baseline and post-intervention"||||0.37
71032862|NCT02444715|141575037|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"Medium intensity~H0: no change between baseline and post-intervention"||||0.34
71032863|NCT02444715|141575037|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"High intensity~H0: no change between baseline and post-intervention"||||0.37
70973786|NCT00546052|141454302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.95|STANDARD_DEVIATION|13.34|<|0.001||95.0|-17.62|-16.27|||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null hypothesis value is 0 mm Hg||-16.27|-17.62|<0.001
70973787|NCT00546052|141454303|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.84|STANDARD_DEVIATION|8.39|<|0.001||95.0|-10.29|-9.39|||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null hypothesis value is 0 mm Hg.||-9.39|-10.29|<0.001
70973788|NCT00546052|141454304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3|STANDARD_DEVIATION|5.4|<|0.001|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||<0.001
70973789|NCT00546052|141454305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.3|STANDARD_DEVIATION|5.2|<|0.001|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||<0.001
70973790|NCT00546052|141454306|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.5|STANDARD_DEVIATION|32.1||0.084|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||0.084
70973791|NCT00546052|141454307|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|18.0||0.654|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||0.654
70973792|NCT00546052|141454308|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1|STANDARD_DEVIATION|43.5||0.336|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||0.336
70973793|NCT00546052|141454309|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|17.0||0.001|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||0.001
70973794|NCT00546052|141454310|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.2|STANDARD_DEVIATION|63.8||0.001|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||0.001
70973795|NCT00546052|141454311|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|8.7||0.613|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||0.613
70973796|NCT01928381|141454323|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.23||0.5695|TWO_SIDED|95.0|-0.34|0.61|||Mixed Models Analysis|||||0.61|-0.34|0.5695
70973797|NCT01928381|141454323|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.23||0.8905|TWO_SIDED|95.0|-0.43|0.49|||Mixed Models Analysis|||||0.49|-0.43|0.8905
70973798|NCT01928381|141454323|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.23||0.4822|TWO_SIDED|95.0|-0.3|0.64|||Mixed Models Analysis|||||0.64|-0.30|0.4822
70973799|NCT01928381|141454324|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.31|STANDARD_ERROR_OF_MEAN|0.25||0.2237|TWO_SIDED|95.0|-0.2|0.82|||Mixed Models Analysis||In direction of Pregabalin|||0.82|-0.20|0.2237
70973800|NCT01928381|141454324|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.25||0.0978|TWO_SIDED|95.0|-0.93|0.08|||Mixed Models Analysis||In direction of Pregabain, positive control|||0.08|-0.93|0.0978
70973801|NCT01928381|141454324|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.25||0.661|TWO_SIDED|95.0|-0.62|0.4|||Mixed Models Analysis|||||0.40|-0.62|0.6610
70973802|NCT02392429|141454348|NON_INFERIORITY|we tested the null hypothesis that the NPV of the post-treatment FLT PET/CT scan was less than or equal to the NPV of the day 14 nadir bone marrow biopsy (estimated to be 0.64 by Hussein et al) against the one-sided alternative hypothesis that the NPV was greater than 0.64 using the exact binomial test.|||||>|0.99|||||||binomial exact test|||||||>0.99
70973803|NCT02392429|141454349|NON_INFERIORITY|we tested the null hypothesis that the PPV of the post-treatment FLT PET/CT scan was less than or equal to the PPV of the day 14 nadir bone marrow biopsy (estimated to be 0.79by Hussein et al) against the one-sided alternative hypothesis that the PPV was greater than 0.79 using the exact binomial test.||||||0.06|||||||binomial exact test|||||||0.06
70973804|NCT02392429|141454353|EQUIVALENCE|no margin was assumed||||||0.68|||||||log-rank test|||Kaplan-Meier curves were constructed for the positive and negative scan groups, and the null hypothesis that the survival distributions of the two groups were equal was tested using the log-rank test.||||0.68
70973805|NCT02392429|141454354|EQUIVALENCE|no margin was assumed||||||0.08|||||||log-rank test|||Kaplan-Meier curves were constructed for the positive and negative scan groups, and the null hypothesis that the survival distributions of the two groups were equal was tested using the log-rank test.||||0.08
70973806|NCT04137887|141454387|SUPERIORITY|Superiority of QIV-HD effectiveness over QIV-SD was demonstrated if the lower bound of the Confidence intervals (CIs) for relative vaccine effectiveness (rVE); expressed in percentage (%) was more than (\>) 0%.|Relative Vaccine Effectiveness|5.54|||||TWO_SIDED|95.0|-12.43|20.66|||||rVE: % reduction of 1st occurrence of cardiovascular/respiratory hospitalization cases in QIV-HD group compared to QIV-SD group. 2-sided 95% CIs for rVE was calculated by exact method assuming Binomial distribution of number of cases in both groups.|||20.66|-12.43|
70973807|NCT04137887|141454388|SUPERIORITY|Superiority of QIV-HD effectiveness over QIV-SD was demonstrated if the lower bound of the CIs for rVE, expressed in % was \> 0%.|Relative Vaccine Effectiveness|5.4|||||TWO_SIDED|95.0|-27.99|30.14|||||rVE: % reduction of 1st occurrence of cardiovascular/respiratory hospitalization cases in QIV-HD group compared to QIV-SD group. 2-sided 95% CIs for rVE was calculated by exact method assuming Binomial distribution of number of cases in both groups.|Statistical analysis for diseases of respiratory system.||30.14|-27.99|
70973808|NCT04137887|141454388|SUPERIORITY|Superiority of QIV-HD effectiveness over QIV-SD was demonstrated if the lower bound of the CIs for rVE, expressed in % was \> 0%.|Relative Vaccine Effectiveness|7.09|||||TWO_SIDED|95.0|-15.04|25.0|||||rVE: % reduction of 1st occurrence of cardiovascular/respiratory hospitalization cases in QIV-HD group compared to QIV-SD group. 2-sided 95% CIs for rVE was calculated by exact method assuming Binomial distribution of number of cases in both groups.|Statistical analysis for diseases of circulatory system.||25.00|-15.04|
71032864|NCT02444715|141575037|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"High intensity~H0: no change between baseline and post-intervention"||||0.59
71032865|NCT02444715|141575038|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.64
70973809|NCT04183335|141454412|SUPERIORITY||Odds Ratio (OR)|6.5|||<|0.0001|TWO_SIDED|95.0|2.78|15.41||Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when primary outcome measure was statistically significant at two-sided 0.05.||15.41|2.78|<0.0001
70973810|NCT04183335|141454413|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0004|TWO_SIDED|95.0|1.81|8.98||Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||8.98|1.81|0.0004
70973811|NCT04183335|141454414|SUPERIORITY||Odds Ratio (OR)|6.9|||<|0.0001|TWO_SIDED|95.0|2.49|19.05||Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||19.05|2.49|<0.0001
70973812|NCT04183335|141454415|SUPERIORITY||LS mean difference|-26.67|||<|0.0001|TWO_SIDED|95.0|-38.44|-14.9||Threshold of significance at 0.05.|ANCOVA||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-14.90|-38.44|<0.0001
70973813|NCT04183335|141454416|SUPERIORITY||Least square mean difference|-6.19|||<|0.0001|TWO_SIDED|95.0|-8.34|-4.05||Threshold of significance at 0.05.|ANCOVA||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-4.05|-8.34|<0.0001
70973814|NCT04183335|141454417|SUPERIORITY||Least square mean difference|-2.17|||<|0.0001|TWO_SIDED|95.0|-3.07|-1.28||Threshold of significance at 0.05.|ANCOVA||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-1.28|-3.07|<0.0001
70973815|NCT04183335|141454418|SUPERIORITY||Least square mean difference|-2.6||||0.0082|TWO_SIDED|95.0|-4.52|-0.67||Threshold of significance at 0.05.|ANCOVA||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-0.67|-4.52|0.0082
70973816|NCT04183335|141454426|SUPERIORITY||LS mean difference|-0.7||||0.0119|TWO_SIDED|95.0|-1.25|-0.15||Threshold of significance at \<0.05 level.|ANCOVA||Dupilumab 300 mg Q2W versus Placebo|||-0.15|-1.25|0.0119
71032866|NCT02444715|141575038|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.14
70973817|NCT05064059|141454436|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.4183|TWO_SIDED|95.0|0.8|1.2||One-sided p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\>=18 months, \<18 months).|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization.|||1.20|0.80|0.4183
70973818|NCT05064059|141454437|SUPERIORITY||Hazard Ratio (HR)|1.34||||0.9967|TWO_SIDED|95.0|1.09|1.64||One-sided nominal p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\>=18 months, \<18 months).|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization.|||1.64|1.09|0.9967
70973819|NCT05064059|141454438|SUPERIORITY||Difference in percentage|5.9||||0.0007|TWO_SIDED|95.0|2.5|10.1||One-sided, nominal p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Miettinen & Nurminen Method||Difference in percentage and 95% CI were based on the Miettinen \& Nurminen method stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization.|||10.1|2.5|0.0007
70973820|NCT05064059|141454442|OTHER||Difference in Least Square (LS) Means|-3.08||||0.1318|TWO_SIDED|95.0|-7.09|0.93||Two-sided p-value based on t-test.|t-test, 2 sided||Calculated using a cLDA model with PRO scores as response variable with covariates for treatment by study visit interaction \& stratified by geographic region, presence of liver metastasis \& time from diagnosis of metastatic disease to randomization.|||0.93|-7.09|0.1318
70973821|NCT05064059|141454443|OTHER||Difference in LS Means|-0.95||||0.637|TWO_SIDED|95.0|-4.93|3.02||Two-sided p-value based on t-test.|t-test, 2 sided||Calculated using a cLDA model with PRO scores as response variable with covariates for treatment by study visit interaction \& stratified by geographic region, presence of liver metastasis \& time from diagnosis of metastatic disease to randomization.|||3.02|-4.93|0.6370
70973822|NCT05064059|141454444|OTHER||Difference in LS Means|3.86||||0.1846|TWO_SIDED|95.0|-1.85|9.57||Two-sided p-value based on t-test.|t-test, 2 sided||Calculated using a cLDA model with PRO scores as response variable with covariates for treatment by study visit interaction \& stratified by geographic region, presence of liver metastasis \& time from diagnosis of metastatic disease to randomization.|||9.57|-1.85|0.1846
71032867|NCT00095212|141575041|SUPERIORITY_OR_OTHER|||||||0.04|||||||longitudinal linear mixed effects model|||||||0.04
71032868|NCT00095212|141575042|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Longitudinal linear mixed effects model|||The study was powered at 80% to detect a significant treatment difference of 2.7 kg in lean body mass between the two groups with 25 randomized patients and a 15% assumed dropout rate, using a two sided 5.0 percent significance level.||||0.02
71032869|NCT00095212|141575043|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Longitudinal mixed methods model|||The study was powered at 80% to detect a significant treatment difference of 2.7 kg in lean body mass between the two groups with 25 randomized patients and a 15% assumed dropout rate, using a two sided 5.0 percent significance level.||||0.02
71095008|NCT06377488|141698100|SUPERIORITY||Mean Population Estimate|67.0|STANDARD_ERROR_OF_MEAN|2.32|||TWO_SIDED|95.0|62.2|71.8|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Mean estimates were conducted for myopes using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a one-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 15 and 26 subjects were required to test for superiority for CLUE handling scores for hyperopes and myopes, respectively.||71.8|62.2|
70973823|NCT05064059|141454445|OTHER||Difference in LS Means|0.56||||0.841|TWO_SIDED|95.0|-4.96|6.08||Two-sided p-value based on t-test.|t-test, 2 sided||Calculated using a cLDA model with PRO scores as response variable with covariates for treatment by study visit interaction \& stratified by geographic region, presence of liver metastasis \& time from diagnosis of metastatic disease to randomization.|||6.08|-4.96|0.8410
70973824|NCT05064059|141454446|OTHER||Hazard Ratio (HR)|1.0||||0.5094|TWO_SIDED|95.0|0.64|1.58||One-sided p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\>=18 months, \<18 months).|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization.|||1.58|0.64|0.5094
71032870|NCT00095212|141575044|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Longitudinal mixed methods model|||The study was powered at 80% to detect a significant treatment difference of 2.7 kg in lean body mass between the two groups with 25 randomized patients and a 15% assumed dropout rate, using a two sided 5.0 percent significance level.||||0.01
71032871|NCT00095212|141575045|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||Chi-squared|||||||0.16
71032872|NCT00095212|141575046|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Chi-squared|||||||0.29
71032873|NCT00095212|141575047|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||Chi-squared|||||||0.75
71032874|NCT00095212|141575048|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Chi-squared|||||||0.14
71032875|NCT00095212|141575049|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||t-test, 2 sided|||||||0.26
71032876|NCT00095212|141575050|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||t-test, 2 sided|||||||0.22
71154129|NCT01935934|141800811|OTHER||||||||||||||||||"Trial design discriminated between co-primary endpoints of objective RR of 30% (vs 10%) and 12-week PFS of 55% (vs 30%). The design had 86% power to detect a true objective RR of at least 30% and at least 90% power to detect a true 12-week PFS rate of atleast 55% (or a median PFS of 3.4 months).~The parallel exploratory cohort of uncommon histology cancers was analyzed independently."|||
71154130|NCT03062358|141800873|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.018|TWO_SIDED|95.0|0.63|0.99||Log-rank test|One-sided p-value|Stratified by macrovascular invasion, α-Fetoprotein and region with all cells that correspond to macrovascular invasion=Yes combined|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate||Stratified by macrovascular invasion (Yes vs. No), α-Fetoprotein (ng/mL) (\< 200 vs. ≥ 200) and region (China vs. ex-China) with all cells that correspond to macrovascular invasion=Yes combined.|0.99|0.63|0.0180
70973825|NCT05064059|141454447|OTHER||Hazard Ratio (HR)|1.51||||0.9704|TWO_SIDED|95.0|0.98|2.33||One-sided p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\>=18 months, \<18 months).|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization.|||2.33|0.98|0.9704
71032877|NCT00095212|141575051|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||t-test, 2 sided|||||||0.94
71032878|NCT02305758|141575065|SUPERIORITY||Hazard Ratio (HR)|0.939|||||TWO_SIDED|95.0|0.596|1.48||||||Comparisons between treatment groups were performed using the Cox Proportional Hazard Model, stratified by planned bevacizumab use (planned use versus no planned use).||1.480|0.596|
71032879|NCT02305758|141575066|SUPERIORITY||Hazard Ratio (HR)|1.261|||||TWO_SIDED|95.0|0.738|2.156||||||Comparisons between treatment groups were performed using the Cox Proportional Hazard Model, stratified by planned bevacizumab use (planned use versus no planned use).||2.156|0.738|
71032880|NCT02305758|141575067|SUPERIORITY||Difference in proportions|-4.62|||||TWO_SIDED|95.0|-21.4|12.1|||Mantel Haenszel|||Comparisons between treatment groups were performed using the Mantel-Haenszel method, stratified by planned bevacizumab use (planned use versus no planned use).||12.1|-21.4|
71032881|NCT01379664|141575068|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|1.06||||0.24|TWO_SIDED|95.0|0.97|1.16|||Wilcoxon (Mann-Whitney)|||||1.16|0.97|0.24
71032882|NCT01379664|141575069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.87|TWO_SIDED|95.0|-0.23|0.19|||Generalized estimating equation model|Generalized estimating equation model weighted by inverse propensity score||||0.19|-0.23|0.87
71032883|NCT01379664|141575070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.74|TWO_SIDED|95.0|-4.7|3.3|||Generalized estimating equation model|Generalized estimating equation model weighted by propensity score||||3.3|-4.7|0.74
71032884|NCT03616106|141575085|OTHER||Slope|-15.103||||0.859|TWO_SIDED|95.0|-184.574|154.369||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||154.369|-184.574|0.859
71032885|NCT03616106|141575086|OTHER||Slope|28.243||||0.213|TWO_SIDED|95.0|-16.694|73.179||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||73.179|-16.694|0.213
71032886|NCT03616106|141575087|OTHER||Slope|58.993||||0.031|TWO_SIDED|95.0|5.713|112.274||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||112.274|5.713|0.031
71032887|NCT03616106|141575088|OTHER||Slope|-0.0651||||0.053|TWO_SIDED|95.0|-1.313|0.01||The p-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||Viral load variables were log transformed for regression analyses.||0.010|-1.313|0.053
71032888|NCT03616106|141575089|OTHER||Slope|-1.601||||0.008|TWO_SIDED|95.0|-2.761|-0.442||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||-0.442|-2.761|0.008
71032889|NCT03616106|141575090|OTHER||Slope|-2.674||||0|TWO_SIDED|95.0|-3.934|-1.415||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||-1.415|-3.934|0.000
71095009|NCT06377488|141698101|SUPERIORITY||Central Posterior Mean Estimate|0.966|STANDARD_DEVIATION|0.0135|||TWO_SIDED|95.0|0.933|0.988|||Bayesian beta-binomial model|Bayesian beta-binomial model with correlated binary data.||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.99 and an intraclass correlation of 0.70 with 5000 replicating trials, that 140 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible.||0.988|0.933|
71095010|NCT05073315|141698106|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Ratio Geometric Least Square Mean (GMR)|1.0516|||||TWO_SIDED|90.0|0.901|1.2273||||||||1.2273|0.9010|
71095011|NCT05073315|141698107|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Least Square Mean Ratio|1.0044|||||TWO_SIDED|90.0|0.8717|1.1574||||||||1.1574|0.8717|
71095012|NCT05073315|141698110|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Mean Difference (Final Values)|-2.47|||||TWO_SIDED|90.0|-5.23|0.29||||||||0.29|-5.23|
71095013|NCT05537571|141698124|SUPERIORITY||Mean Difference (Final Values)|-82.8|||<|0.0001|TWO_SIDED|95.0|-88.19|-77.39|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-77.39|-88.19|<0.0001
71095014|NCT05537571|141698124|SUPERIORITY||Mean Difference (Final Values)|-81.3|||<|0.0001|TWO_SIDED|95.0|-86.68|-76.0|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-76.0|-86.68|<0.0001
70973826|NCT05064059|141454448|OTHER||Hazard Ratio (HR)|1.82||||0.9905|TWO_SIDED|95.0|1.11|2.98||One-sided p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\>=18 months, \<18 months).|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization.|||2.98|1.11|0.9905
70973827|NCT05064059|141454449|OTHER||Hazard Ratio (HR)|1.86||||0.9853|TWO_SIDED|95.0|1.06|3.26||One-sided p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\>=18 months, \<18 months).|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization|||3.26|1.06|0.9853
70973828|NCT03806127|141454515|OTHER||Cochran-Mantel-Haenszel (CMH) Difference|-1.9|||||TWO_SIDED|90.0|-16.1|12.3|||||Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (\< 6 versus ≥ 6) strata, with weights proposed by Greenland and Robins.|||12.3|-16.1|
70973829|NCT03806127|141454516|OTHER||CMH Difference|9.1|||||TWO_SIDED|90.0|-4.8|22.9|||||Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (\< 6 versus \>= 6) strata, with weights proposed by Greenland and Robins.|IBS-D Participants||22.9|-4.8|
70973830|NCT03806127|141454516|OTHER||CMH Difference|-0.1|||||TWO_SIDED|90.0|-16.7|16.4|||||Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (\< 6 versus \>= 6) strata, with weights proposed by Greenland and Robins.|IBS-M Participants||16.4|-16.7|
70973831|NCT03806127|141454516|OTHER||CMH Difference|5.3|||||TWO_SIDED|90.0|-5.4|15.9|||||Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (\< 6 versus \>= 6) strata, with weights proposed by Greenland and Robins.|All Participants||15.9|-5.4|
70973832|NCT03806127|141454517|OTHER||CMH Difference|1.6|||||TWO_SIDED|90.0|-11.7|14.9|||||Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (\< 6 versus \>= 6) strata, with weights proposed by Greenland and Robins.|||14.9|-11.7|
70973833|NCT03806127|141454518|OTHER||CMH Difference|6.7|||||TWO_SIDED|90.0|-5.5|18.8|||||Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (\< 6 versus ≥ 6) strata, with weights proposed by Greenland and Robins.|||18.8|-5.5|
70973834|NCT03946670|141454546|SUPERIORITY|||||||0.769|||||||Cochran-Mantel-Haenszel|stratified by the randomization stratification factor IPSS-R category||||||0.769
70973835|NCT03946670|141454547|SUPERIORITY||Cox Proportional Hazard|0.749||||0.1022|TWO_SIDED|95.0|0.479|1.173|||Log Rank|stratified by the randomization stratification factor IPSS-R category||||1.173|0.479|0.1022
70973836|NCT04161495|141454625|NON_INFERIORITY|Non-inferiority would be established if the upper bound of the one-sided 97.5% CI was less than 4.|Mean difference|-2.3|||||TWO_SIDED|95.0|-3.49|-1.11||||||Hierarchical testing framework: used to control type I error for secondary OM analyses. Statistical testing of Arm A intra-participant comparison non-inferiority continued only when estimation of previous OM was statistically significant at 0.05 level. For Arm A intra-participant comparison, mean difference and 95% confidence interval (CI) were estimated by NB regression model in which treatment (BIVV001 prophylaxis vs historical prophylaxis vs historical prophylaxis) was treated as covariate.||-1.11|-3.49|
71008737|NCT02055976|141525249|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-29.186|STANDARD_ERROR_OF_MEAN|11.044||0.005|TWO_SIDED|95.0|-51.123|-7.249|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-7.249|-51.123|0.005
71095015|NCT05537571|141698124|SUPERIORITY||Mean Difference (Final Values)|-85.6|||<|0.0001|TWO_SIDED|95.0|-90.88|-80.26|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-80.26|-90.88|<0.0001
71095016|NCT05537571|141698125|SUPERIORITY||Mean Difference (Final Values)|-83.1|||<|0.0001|TWO_SIDED|95.0|-88.7|-77.57|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-77.57|-88.7|<0.0001
71032890|NCT03616106|141575104|OTHER||Slope|2.172||||0|TWO_SIDED|95.0|1.448|2.895||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||2.895|1.448|0.000
71032891|NCT03616106|141575105|OTHER||Slope|2.872||||0|TWO_SIDED|95.0|2.1|3.643||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||3.643|2.100|0.000
71032892|NCT03616106|141575106|OTHER||Slope|3.166||||0|TWO_SIDED|95.0|2.487|3.846||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||3.846|2.487|0.000
71032893|NCT03616106|141575107|OTHER||Z Score|3.25||||0.0011|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using the Bonferroni correction. Therefore, the threshold for statistical significance was p≤0.05/3 = .017. Please see statistical analysis plan for further details.|Wilcoxon signed rank|||||||0.0011
71032894|NCT03616106|141575108|OTHER||Z score|3.94||||0.0001|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using the Bonferroni correction. Therefore, the threshold for statistical significance was p≤0.05/3 = .017. Please see statistical analysis plan for further details.|Wilcoxon signed rank|||||||0.0001
71032895|NCT03616106|141575109|OTHER||Z score|4.12||||0|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using the Bonferroni correction. Therefore, the threshold for statistical significance was p≤0.05/3 = .017. Please see statistical analysis plan for further details.|Wilcoxon signed rank|||||||0.000
71032896|NCT03616106|141575110|OTHER||Slope|1.935||||0|TWO_SIDED|95.0|1.055|2.815||This p-value was not adjusted for multiple comparisons. The p-value threshold for statistical significance was, therefore, 0.05|Regression, Linear|||||2.815|1.055|0.000
71032897|NCT03616106|141575111|OTHER||Slope|2.123||||0|TWO_SIDED|95.0|1.184|3.062||The p-value was not adjusted for multiple comparison, therefore, the threshold for statistical significance was 0.05.|Regression, Linear|||||3.062|1.184|0.000
71032898|NCT03616106|141575112|OTHER||Slope|2.552||||0|TWO_SIDED|95.0|1.612|3.492||The p-value was not adjusted for multiple comparison, therefore, the threshold for statistical significance was 0.05.|Regression, Linear|||||3.492|1.612|0.000
71095017|NCT05537571|141698125|SUPERIORITY||Mean Difference (Final Values)|-78.7|||<|0.0001|TWO_SIDED|95.0|-84.18|-73.17|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-73.17|-84.18|<0.0001
71095018|NCT05537571|141698125|SUPERIORITY||Mean Difference (Final Values)|-83.0|||<|0.0001|TWO_SIDED|95.0|-88.43|-77.49|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-77.49|-88.43|<0.0001
71095019|NCT05537571|141698126|SUPERIORITY||Mean Difference (Final Values)|-79.2|||<|0.0001|TWO_SIDED|95.0|-85.25|-73.1|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-73.1|-85.25|<0.0001
71095020|NCT05537571|141698126|SUPERIORITY||Mean Difference (Final Values)|-71.8|||<|0.0001|TWO_SIDED|95.0|-77.81|-65.8|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-65.8|-77.81|<0.0001
71095021|NCT05537571|141698126|SUPERIORITY||Mean Difference (Final Values)|-77.1|||<|0.0001|TWO_SIDED|95.0|-83.09|-71.15|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-71.15|-83.09|<0.0001
71032899|NCT03616106|141575113|OTHER||Z score|-1.57||||0.1167|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using the Bonferroni correction. Therefore, the a priori threshold for statistical significance was p≤0.05/3 = .017. For more details please see the statistical plan.|Wilcoxon signed rank|||||||0.1167
71032900|NCT03616106|141575114|OTHER||Z score|-2.91||||0.0036|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using the Bonferroni correction. Therefore, the a priori threshold for statistical significance was p≤0.05/3 = .017. For more details please see the statistical plan.|Wilcoxon signed rank|||||||0.0036
71032901|NCT03616106|141575115|OTHER||Z score|-3.54||||0.0004|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using the Bonferroni correction. Therefore, the a priori threshold for statistical significance was p≤0.05/3 = .017. For more details please see the statistical plan.|Wilcoxon signed rank|||||||0.0004
71032902|NCT02298322|141575117|OTHER||sucess proportion|91.4|||<|0.0001|TWO_SIDED|95.0|86.2|95.1|||t-test, 1 sided|||||95.1|86.2|<0.0001
71032903|NCT03880266|141575129|SUPERIORITY||Mean Difference (Final Values)|-1.58||||0.244|TWO_SIDED|95.0|-3.76|0.6|||Wilcoxon (Mann-Whitney)|||||0.60|-3.76|0.244
71032904|NCT03880266|141575129|SUPERIORITY||Mean Difference (Final Values)|1.39||||0.168|TWO_SIDED|95.0|-0.65|3.43|||Wilcoxon (Mann-Whitney)|||||3.43|-0.65|0.168
71032905|NCT03880266|141575129|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.699|TWO_SIDED|95.0|-2.39|1.72|||Wilcoxon (Mann-Whitney)|||||1.72|-2.39|0.699
71032906|NCT03880266|141575129|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.833|TWO_SIDED|95.0|-1.94|2.02|||Wilcoxon (Mann-Whitney)|||||2.02|-1.94|0.833
71032907|NCT03880266|141575130|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71032908|NCT03880266|141575130|SUPERIORITY|||||||0.589|||||||Fisher Exact|||||||0.589
71032909|NCT03880266|141575130|SUPERIORITY|||||||0.154|||||||Fisher Exact|||||||0.154
71032910|NCT03880266|141575130|SUPERIORITY|||||||0.646|||||||Fisher Exact|||||||0.646
71032911|NCT03880266|141575131|SUPERIORITY||Mean Difference (Final Values)|-206.5||||0.093|TWO_SIDED|95.0|-451.9|38.9|||t-test, 2 sided|||||38.9|-451.9|0.093
71032912|NCT03880266|141575131|SUPERIORITY||Mean Difference (Final Values)|144.1||||0.186|TWO_SIDED|95.0|-78.6|366.7|||t-test, 2 sided|||||366.7|-78.6|0.186
71032913|NCT03880266|141575131|SUPERIORITY||Mean Difference (Final Values)|-151.7||||0.058|TWO_SIDED|95.0|-309.0|5.7|||t-test, 2 sided|||||5.7|-309.0|0.058
71032914|NCT03880266|141575131|SUPERIORITY||Mean Difference (Final Values)|160.6||||0.186|TWO_SIDED|95.0|-611.2|290.1|||t-test, 2 sided|||||290.1|-611.2|0.186
71032915|NCT03880266|141575132|SUPERIORITY||Mean Difference (Final Values)|-33.62||||0.13|TWO_SIDED|95.0|-78.42|11.17|||t-test, 2 sided|||||11.17|-78.42|0.130
71032916|NCT03880266|141575132|SUPERIORITY||Mean Difference (Final Values)|24.26||||0.518|TWO_SIDED|95.0|-54.62|103.13|||t-test, 2 sided|||||103.13|-54.62|0.518
70921038|NCT02217904|141333225|SUPERIORITY||Posterior mean difference|-1.32|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was \>99%.|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.||||
70921039|NCT02217904|141333225|SUPERIORITY||Posterior mean difference|-1.57|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was \>99%.|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.||||
70921040|NCT02217904|141333225|SUPERIORITY||Posterior mean difference|-1.28|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was \>99%.|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.||||
70921041|NCT02217904|141333225|SUPERIORITY||Posterior mean difference|-1.18|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was \>99%.|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.||||
70921042|NCT04583423|141333256|OTHER||Difference in Percentages|10.4||||0.3504|TWO_SIDED|95.0|-13.4|35.1|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 50-mg MK-3655 minus % placebo|||35.1|-13.4|0.3504
70921043|NCT04583423|141333256|OTHER||Difference in Percentages|9.2||||0.373|TWO_SIDED|95.0|-15.6|32.1|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 100-mg MK-3655 minus % placebo|||32.1|-15.6|0.3730
70921044|NCT04583423|141333256|OTHER||Difference in Percentages|15.4||||0.1428|TWO_SIDED|95.0|-8.5|42.3|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 300-mg MK-3655 minus % placebo|||42.3|-8.5|0.1428
70921045|NCT04583423|141333259|OTHER||Difference in Least Square (LS) Means|19.1|||||TWO_SIDED|95.0|1.7|36.4|||||Difference=LS Mean 50 mg minus LS Mean Placebo|||36.4|1.7|
70921046|NCT04583423|141333259|OTHER||Difference in LS Means|19.0|||||TWO_SIDED|95.0|2.2|35.8|||||Difference=LS Mean 100 mg minus LS Mean Placebo|||35.8|2.2|
70921047|NCT04583423|141333259|OTHER||Difference in LS Means|26.1|||||TWO_SIDED|95.0|9.5|42.8|||||Difference=LS Mean 300 mg minus LS Mean Placebo|||42.8|9.5|
70973837|NCT04161495|141454627|SUPERIORITY|Superiority was declared if the upper bound of the one-sided 97.5% confidence interval was less than 1.|Rate ratio|0.23|||<|0.0001|TWO_SIDED|95.0|0.13|0.42|||Negative binomial regression mode|||Tested according to hierarchical testing procedure (only performed if the previous OM was statistically significant for the considered dosing regimen). For test about Arm A intra-participant comparison superiority, rate ratio and 95% CI were estimated using NB regression model in which treatment (BIVV001 prophylaxis vs historical prophylaxis) was treated as covariate.||0.42|0.13|<0.0001
70973838|NCT04161495|141454629|SUPERIORITY||LS mean difference|-6.74|STANDARD_ERROR_OF_MEAN|1.71||0.0001|TWO_SIDED|95.0|-10.13|-3.36|||Unstructured covariance matrix|An unstructured covariance matrix within a participant was used.||Testing according to hierarchical testing procedure. Only performed if previous OM \[Annualized Bleeding Rate During the Efficacy Period in Prophylaxis Arm - Superiority Analysis\] was statistically significant for considered dosing regimen). Least square (LS) mean difference, standard error and 95% confidence interval were estimated by mixed-effect model with repeated measures (MMRM) using visit as fixed effect and Baseline Haem-A-QOL physical health score as covariate.||-3.36|-10.13|0.0001
70973839|NCT04161495|141454630|SUPERIORITY||LS mean difference|-1.94|STANDARD_ERROR_OF_MEAN|0.67||0.0042|TWO_SIDED|95.0|-3.26|-0.63|||Unstructured covariance matrix|An unstructured covariance matrix within a participant was used.||Testing according to hierarchical testing procedure. Only performed if previous OM \[Change From Baseline in Haem-A-QOL Physical Health Score at Weeks 26 and 52: Prophylaxis Arm\] was statistically significant for considered dosing regimen). LS mean difference, standard error and 95% confidence interval were estimated by MMRM using visit as fixed effect and PROMIS Pain Intensity 3a score as covariate.||-0.63|-3.26|0.0042
71032917|NCT03880266|141575132|SUPERIORITY||Mean Difference (Final Values)|-38.14||||0.061|TWO_SIDED|95.0|-78.32|2.03|||t-test, 2 sided|||||2.03|-78.32|0.061
71032918|NCT03880266|141575132|SUPERIORITY||Mean Difference (Final Values)|-39.34||||0.366|TWO_SIDED|95.0|-128.4|49.72|||t-test, 2 sided|||||49.72|-128.40|0.366
71032919|NCT03880266|141575133|SUPERIORITY|||||||0.515|||||||Fisher Exact|||||||0.515
71032920|NCT03880266|141575133|SUPERIORITY|||||||0.56|||||||Fisher Exact|||||||0.560
71032921|NCT03880266|141575133|SUPERIORITY|||||||0.245|||||||Fisher Exact|||||||0.245
71032922|NCT03880266|141575133|SUPERIORITY|||||||0.29|||||||Fisher Exact|||||||0.290
70973840|NCT04161495|141454631|SUPERIORITY||LS mean difference|-1.54|STANDARD_ERROR_OF_MEAN|0.59||0.0101|TWO_SIDED|95.0|-2.7|-0.37||An unstructured covariance matrix within a participant was used.|Unstructured covariance matrix|||Testing according to hierarchical testing procedure (only performed if previous OM \[Change From Baseline in PROMIS Pain Intensity 3a First Item at Week 52: Prophylaxis Arm\] was statistically significant for considered dosing regimen). LS mean difference, standard error and 95% confidence interval were estimated by MMRM using visit as fixed effect and Baseline Haem-A-QOL physical health score as covariate.||-0.37|-2.70|0.0101
70973841|NCT01764633|141454681|SUPERIORITY||Hazard Ratio (HR)|0.85|||<|0.0001|TWO_SIDED|95.0|0.79|0.92|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|The primary endpoint was compared between treatment groups at a significance level of 0.05.||0.92|0.79|< 0.0001
70973842|NCT01764633|141454682|SUPERIORITY||Hazard Ratio (HR)|0.8|||<|0.0001|TWO_SIDED|95.0|0.73|0.88|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary endpoint reached statistical significance at the 0.05 level, the key secondary endpoint (composite of cardiovascular death, myocardial infarction, and stroke) was tested at a significance level of 0.05.||0.88|0.73|< 0.0001
70973843|NCT01764633|141454683|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.6188|TWO_SIDED|95.0|0.88|1.25|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary and key secondary endpoints reached a statistical significance level of 0.05, then the endpoint of cardiovascular death was tested at a significance level of 0.05.||1.25|0.88|0.6188
70973844|NCT01764633|141454684|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.5368|TWO_SIDED|95.0|0.91|1.19|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints at an overall significant level of 0.01 by applying the Hochberg method.||1.19|0.91|0.5368
70973845|NCT01764633|141454685|SUPERIORITY||Hazard Ratio (HR)|0.73|||<|0.0001|TWO_SIDED|95.0|0.65|0.82|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.||0.82|0.65|< 0.0001
70973846|NCT01764633|141454686|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.0101|TWO_SIDED|95.0|0.66|0.95|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.||0.95|0.66|0.0101
70973847|NCT01764633|141454687|SUPERIORITY||Hazard Ratio (HR)|0.78|||<|0.0001|TWO_SIDED|95.0|0.71|0.86|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.||0.86|0.71|< 0.0001
70973848|NCT01764633|141454688|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.8179|TWO_SIDED|95.0|0.86|1.13|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.||1.13|0.86|0.8179
70973849|NCT01764633|141454689|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0035|TWO_SIDED|95.0|0.65|0.92|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.||0.92|0.65|0.0035
71008738|NCT02055976|141525249|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.01|STANDARD_ERROR_OF_MEAN|11.16|<|0.001|TWO_SIDED|95.0|-62.175|-17.845|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-17.845|-62.175|<0.001
71032923|NCT03161405|141575134|OTHER||Geometric mean ratio|1.9827|||||TWO_SIDED|90.0|1.6446|2.3904||||||A paired t-test on the natural log-transformed parameters was performed. The mean difference and its 90 percent (%) confidence interval (CI) for the log-transformed parameters were exponentiated to obtain the point estimates of the itraconazole effect and 90% CIs.||2.3904|1.6446|
71032924|NCT03161405|141575135|OTHER||Geometric mean ratio|1.2914|||||TWO_SIDED|90.0|1.1199|1.4891||||||A paired t-test on the natural log-transformed parameters was performed. The mean difference and its 90% CI for the log-transformed parameters were exponentiated to obtain the point estimates of the itraconazole effect and 90% CIs.||1.4891|1.1199|
71095022|NCT05537571|141698127|SUPERIORITY||Mean Difference (Final Values)|-13.3|||<|0.0001|TWO_SIDED|95.0|-18.55|-8.09|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-8.09|-18.55|<0.0001
70973850|NCT04418765|141454696|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-3.9|-2.5||Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value \<α, where α = 0.05. Here it is test no. 1 of testing order.|Mixed Models Analysis|||Analysis was performed using a restricted maximum likelihood (REML)-based mixed model for repeated measurements (MMRM) with month (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, 21-24), country, stratification factor (monthly MHDs at baseline: ≤14/\>14) and treatment as factors, baseline score as a continuous covariate, treatment-by-month interaction, baseline score-by-month interaction, and stratum-by-month interaction. A testing strategy was applied to ensure protection of the type 1 error.||-2.5|-3.9|<0.0001
70973851|NCT04418765|141454696|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-3.4|-2.0||Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value \<α, where α = 0.05. Here it is test no. 3 of testing order.|Mixed Models Analysis|||"Analysis was performed using an REML-based MMRM with month (Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20, Weeks 21-24), country, stratification factor (monthly MHDs at baseline: ≤14/\>14) and treatment as factors, baseline score as a continuous covariate, treatment-by-month interaction, baseline score-by-month interaction, and stratum-by-month interaction.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error."||-2.0|-3.4|<0.0001
70973852|NCT04418765|141454697|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Odds Ratio (OR)|6.58|||<|0.0001|TWO_SIDED|95.0|4.41|10.01||Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value \<α, where α = 0.05. Here it is test no. 2 of testing order.|Regression, Logistic|||"Analysis was performed using logistic regression model including baseline MMDs as a continuous covariate, and treatment and stratification factor (MHD at baseline: ≤14/\>14) as factors.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error."||10.01|4.41|<0.0001
70973853|NCT04418765|141454697|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Odds Ratio (OR)|4.91|||<|0.0001|TWO_SIDED|95.0|3.29|7.47||Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value \<α, where α = 0.05. Here it is test no. 4 of testing order.|Regression, Logistic|||"Analysis was performed using logistic regression model including baseline MMDs as a continuous covariate, and treatment and stratification factor (MHD at baseline: ≤14/\>14) as factors.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error."||7.47|3.29|<0.0001
70973854|NCT04418765|141454698|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|-4.5|-3.0||Threshold for significance: p-value \<α, where α = 0.05. Here it is test no. 5a of testing order.|Mixed Models Analysis|Testing continued only, if the previous comparison was statistically significant.||"Analysis was performed using an REML-based MMRM with month (Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20, Weeks 21-24), country, stratification factor (monthly MHDs at baseline: ≤14/\>14) and treatment as factors, baseline score as a continuous covariate, treatment-by-month interaction, baseline score-by-month interaction, and stratum-by-month interaction.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error."||-3.0|-4.5|<0.0001
71008437|NCT00792922|141524771|SUPERIORITY|Predicted prevalence was estimated in each community using the baseline observed prevalence, treatment arm \& parameters estimated from square root transformed model.For each arm estimated prevalences were averaged.Difference in adjusted mean prevalence for enhanced arm and standard arm was calculated.For confidence intervals for adjusted difference,steps 1 to 4 for 1000 bootstrap samples were repeated.Median of adjusted mean differences, corresponding 2.5 % \& 97.5 % percentiles were reported.|Mean Difference (Final Values)|1.4||||0.22|TWO_SIDED|95.0|-1.0|3.8|||Regression, Linear|||"This is analysis done in Tanzania:~Only the main effect of coverage was analyzed.We hypothesized that increasing the coverage of MDA to greater than 90 % as monitored in children would result in more rapid decline in infection and trachoma compared to usual coverage.Here we are looking at the prevalence of infection."||3.8|-1|0.22
71095023|NCT05537571|141698127|SUPERIORITY||Mean Difference (Final Values)|-9.9|||=|0.0002|TWO_SIDED|95.0|-15.02|-4.68|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-4.68|-15.02|=0.0002
71095024|NCT05537571|141698127|SUPERIORITY||Mean Difference (Final Values)|-15.0|||<|0.0001|TWO_SIDED|95.0|-20.1|-9.82|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-9.82|-20.1|<0.0001
70973855|NCT04418765|141454698|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|-3.8|-2.2||Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be \<α/3, \<α/2, and \<α, where α = 0.05. Here it is test no. 6a of testing order.|Mixed Models Analysis|Testing continued only, if the previous comparison was statistically significant.||"Analysis was performed using an REML-based MMRM with month (Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20, Weeks 21-24), country, stratification factor (monthly MHDs at baseline: ≤14/\>14) and treatment as factors, baseline score as a continuous covariate, treatment-by-month interaction, baseline score-by-month interaction, and stratum-by-month interaction.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error."||-2.2|-3.8|<0.0001
70973856|NCT04418765|141454699|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Odds Ratio (OR)|11.43|||<|0.0001|TWO_SIDED|95.0|5.22|30.15||Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be \<α/3, \<α/2, and \<α, where α = 0.05. Here it is test no. 5b of testing order.|Regression, Logistic|||"Analysis was performed using logistic regression model including baseline MMDs as a continuous covariate, and treatment and stratification factor (MHD at baseline: ≤14/\>14) as factors.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.~Testing continued only, if the previous comparison was statistically significant."||30.15|5.22|<0.0001
70973857|NCT04418765|141454699|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Odds Ratio (OR)|9.19|||<|0.0001|TWO_SIDED|95.0|4.16|24.35||Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be \<α/3, \<α/2, and \<α, where α = 0.05. Here it is test no. 6b of testing order.|Regression, Logistic|||"Analysis was performed using logistic regression model including baseline MMDs as a continuous covariate, and treatment and stratification factor (MHD at baseline: ≤14/\>14) as factors.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.~Testing continued only, if the previous comparison was statistically significant."||24.35|4.16|<0.0001
70973858|NCT04418765|141454700|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Mean Difference (Final Values)|-5.4|STANDARD_ERROR_OF_MEAN|0.63|<|0.0001|TWO_SIDED|95.0|-6.7|-4.2||Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be \<α/3, \<α/2, and \<α, where α = 0.05. Here it is test no. 5c of testing order.|Mixed Models Analysis|||"Analysis was performed using MMRM with the following fixed effects: visit, country, stratification factor (MHDs at baseline: ≤14/\>14) and treatment as factors, baseline HIT-6 Total Score as a continuous covariate, baseline score-by-visit interaction, treatment-by-visit interaction, and stratum-by-visit interaction.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.~Testing continued only, if the previous comparison was statistically significant."||-4.2|-6.7|<0.0001
70973859|NCT04418765|141454700|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|0.63|<|0.0001|TWO_SIDED|95.0|-5.0|-2.5||Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be \<α/3, \<α/2, and \<α, where α = 0.05. Here it is test no. 6c of testing order.|Mixed Models Analysis|||"Analysis was performed using MMRM with the following fixed effects: visit, country, stratification factor (MHDs at baseline: ≤14/\>14) and treatment as factors, baseline HIT-6 Total Score as a continuous covariate, baseline score-by-visit interaction, treatment-by-visit interaction, and stratum-by-visit interaction.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.~Testing continued only, if the previous comparison was statistically significant."||-2.5|-5.0|<0.0001
70973860|NCT01789970|141454737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63|||<|0.001|TWO_SIDED|95.0|0.26|1.0||5% significance level|ANCOVA|The model included treatment, study center, opioid status, and baseline WPI score.|Placebo - Hydrocodone ER|The least squares means of the change from baseline to week 12 in WPI were compared between the active drug and placebo treatment groups.||1.00|0.26|<0.001
71095025|NCT05537571|141698128|SUPERIORITY||Mean Difference (Final Values)|-12.3|||<|0.0001|TWO_SIDED|95.0|-17.62|-7.08|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-7.08|-17.62|<0.0001
70973861|NCT01789970|141454738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|||<|0.001|TWO_SIDED|95.0|0.25|0.91||5% significance level|ANCOVA|The model included treatment, study center, opioid status, and baseline WPI score.|Placebo - Hydrocodone ER|The least squares means of the change from baseline to week 12 in API were compared between the active drug and placebo treatment groups.||0.91|0.25|<0.001
70973862|NCT01789970|141454739|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.059|TWO_SIDED|95.0|0.5|1.01||5% significance level|Wald chi-square|Cox proportional hazards model with treatment, baseline worst pain intensity (WPI), opioid status, and center in the model||||1.01|0.5|0.059
70973863|NCT01789970|141454740|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.0293|TWO_SIDED|95.0|0.47|0.96||5% significance level|Regression, Logistic|stratified by center with the following effects: treatment group, baseline API, and opioid status.|Hydrocodone ER / Placebo|API increase \>=30% and API \>=5||0.96|0.47|0.0293
70973864|NCT01789970|141454741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.557|TWO_SIDED|95.0|-1.2|0.65||5% significance level|ANCOVA|Model with the following effects: treatment, study center, opioid status, and baseline RMDQ score.|Placebo - Hydrocodone ER|||0.65|-1.20|0.557
70973865|NCT02123485|141454757|SUPERIORITY|||||||0.3|||||||Chi-squared|||||||0.30
70973866|NCT03423342|141454760|SUPERIORITY||Mean Difference (Net)|30.2|STANDARD_ERROR_OF_MEAN|3.3|<|0.0001|TWO_SIDED|||||The updated p-value is calculated and not a threshold for statistical significance.|t-test, 2 sided|||||||<0.0001
70973867|NCT03423342|141454761|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.0|<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
70973868|NCT03423342|141454762|SUPERIORITY||Mean Difference (Net)|19.0|STANDARD_ERROR_OF_MEAN|48.0|<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
70973869|NCT03423342|141454763|SUPERIORITY||Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|17.0|<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
70973870|NCT03423342|141454764|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|3.1|<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
70973871|NCT03423342|141454765|SUPERIORITY||Mean Difference (Net)|0.81|STANDARD_ERROR_OF_MEAN|0.66|<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
70973872|NCT03285243|141454899|OTHER|||||||0.001||||||A priori, All p-values \< 0.05 were considered statistically significant.|Chi-squared|||||||0.001
70973873|NCT03285243|141454900|OTHER|||||||0.002||||||a priori, all p-values \< 0.05 were considered statistically significant.|Regression, Logistic|||||||0.002
70973874|NCT00725075|141454913|SUPERIORITY_OR_OTHER||Mean Change From Baseline|-2.26||||0.267|TWO_SIDED|95.0|-6.25|1.74|||ANCOVA|ANCOVA model with the baseline value as covariate and with treatment group and center as fixed factors||Comparison of Mean Change in Baseline: Least Squared Estimates with Statistical Inference.||1.74|-6.25|0.267
70973875|NCT00725075|141454913|SUPERIORITY_OR_OTHER||Mean Change From Baseline|-0.08||||0.966|TWO_SIDED|95.0|-3.91|3.74|||ANCOVA|ANCOVA model with the baseline value as covariate and with treatment group and center as fixed factors||Comparison of Mean Change in Baseline: Least Squared Estimates with Statistical Inference.||3.74|-3.91|0.966
70973876|NCT02979431|141454941|SUPERIORITY||||||<|0.001|||||||Log Rank|||The primary endpoint was analysed using log-rank test to compare time-to-BQL between each of the ALX-0171 treatment groups and the combined placebo group. The tests were performed in a sequential way to preserve the family-wise error rate at 0.05.||||<0.001
70973877|NCT02979431|141454941|SUPERIORITY||||||=|0.001|||||||Log Rank|||The primary endpoint was analysed using log-rank test to compare time-to-BQL between each of the ALX-0171 treatment groups and the combined placebo group. The tests were performed in a sequential way to preserve the family-wise error rate at 0.05.||||=0.001
70973878|NCT02979431|141454941|SUPERIORITY||||||<|0.001|||||||Log Rank|||The primary endpoint was analysed using log-rank test to compare time-to-BQL between each of the ALX-0171 treatment groups and the combined placebo group. The tests were performed in a sequential way to preserve the family-wise error rate at 0.05.||||<0.001
70973879|NCT02979431|141454942|SUPERIORITY||Mean Difference (Net)|-0.6452|STANDARD_ERROR_OF_MEAN|0.5843|=|0.271|TWO_SIDED||||||Mixed Models Analysis|||A comparison for change from Baseline in GSS to Day 2, 5 hours post-dose was performed using a contrast analysis on a longitudinal mixed model with random factor subject and fixed effects baseline value, treatment group and timepoint, including the treatment-by-timepoint interaction term. All data up to + including Day 3 were used in the longitudinal mixed model. The Kenward-Roger approximation of degrees of freedom was used.The model was fitted using an unstructured variance-covariance matrix.||||=0.271
70973880|NCT02979431|141454942|SUPERIORITY||Difference in LS means|-0.4904|STANDARD_ERROR_OF_MEAN|0.5862|=|0.404|TWO_SIDED||||||Mixed Models Analysis|||||||=0.404
70973881|NCT02979431|141454942|SUPERIORITY||Difference in LS means|-0.2156|STANDARD_ERROR_OF_MEAN|0.5842|=|0.713|TWO_SIDED||||||Mixed Models Analysis|||||||=0.713
70973882|NCT02004873|141454952|SUPERIORITY_OR_OTHER||Kaplan-Meier survival probability (%)|96.0|||<|0.0001|TWO_SIDED|98.66|93.3|97.6||The threshold for statistical significance was 0.0067, determined by the pre-specified alpha spending function for the interim analysis.|z-test, 1-sided||"The major complication free rate (i.e. survival probability) was estimated using the Kaplan-Meier method.~The coverage level for the confidence interval was 98.66%, determined by the pre-specified alpha spending function for the interim analysis."|"Null hypothesis: Major complication free rate at 6 months post-implant is less than or equal to 83%.~Alternative hypothesis: Major complication free rate at 6 months post-implant is greater than 83%."||97.6|93.3|<0.0001
70973883|NCT02004873|141454953|SUPERIORITY_OR_OTHER||Percentage of subjects (%)|98.3|||<|0.0001|TWO_SIDED|98.66|95.4|99.6||The threshold for statistical significance was 0.0067, determined by the pre-specified alpha spending function for the interim analysis.|Exact Binomial test||The coverage level for confidence interval was 98.66%, determined by the pre-specified alpha spending function for the interim analysis.|"Null hypothesis: Percentage of subjects with an adequate pacing capture threshold at 6-months post-implant is less than or equal to 80%.~Alternative hypothesis: Percentage of subjects with an adequate pacing capture threshold at 6-months post-implant is greater than 80%."||99.6|95.4|<0.0001
71008739|NCT02055976|141525249|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.17|STANDARD_ERROR_OF_MEAN|10.906||0.614|TWO_SIDED|95.0|-18.502|24.842|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||24.842|-18.502|0.614
70973884|NCT02004873|141454954|SUPERIORITY_OR_OTHER||Percentage of subjects (%)|99.6|||<|0.0001|TWO_SIDED|98.66|97.5|100.0||Holm adjustment for multiple comparisons for secondary objectives was used. The threshold for statistical significance was 0.0067, determined by the pre-specified alpha spending function for the interim analysis.|Exact Binomial test||The coverage level for confidence interval was 98.66%, determined by the pre-specified alpha spending function for the interim analysis.|"Null hypothesis: Percentage of subjects with VCMT within 0.5 Volts of auto decrement PCT at 6 months post-implant is less than or equal to 85%.~Alternative hypothesis: Percentage of subjects with VCMT within 0.5 Volts of auto decrement PCT at 6 months post-implant is greater than 85%."||100.0|97.5|<0.0001
71032925|NCT03161405|141575136|OTHER||Geometric mean ratio|1.2783|||||TWO_SIDED|90.0|1.0965|1.4904||||||A paired t-test on the natural log-transformed parameters was performed. The mean difference and its 90% CI for the log-transformed parameters were exponentiated to obtain the point estimates of the itraconazole effect and 90% CIs.||1.4904|1.0965|
71032926|NCT00837486|141575137|SUPERIORITY_OR_OTHER||||||=|0.53||||||"one-sided P-value~per protocol responder rates: Active Group = 20.0%, Control Group = 14.3%"|Fisher Exact|||The study originally required a sample size of 208 subjects in order to have 90% power to detect a statistically significant difference between the responder rate of the active and control groups. With this 30-subject cohort, and only 29 subjects completing the blinded-treatment phase per protocol, the comparison of response rates was not adequately powered. The P-value is presented only to describe the outcomes of the two groups.||||=0.53
71032927|NCT04189848|141575197|OTHER|Treatment comparison|Treatment difference|-5.9|||<|0.0001|TWO_SIDED|95.0|-8.2|-3.6|||ANOVA|||Intensity of injection site pain was analysed by a fixed analysis of variance model with VAS pain score as the dependent variable, and product, injection side (right side, left side), injection number (first injection, second injection), and participant as fixed effects.||-3.6|-8.2|<0.0001
71032928|NCT00819741|141575198|NON_INFERIORITY_OR_EQUIVALENCE|"If non-inferiority was shown (that was if H0 was rejected), then superiority of repaglinide and metformin combination therapy compared to repaglinide monotherapy would be claimed if the upper limit of the 95% CI for the difference was lower than 0%.~The non-inferiority margin for HbA1c was set to 0.4%."|Estimated treatment difference, LS Mean|-0.302|STANDARD_ERROR_OF_MEAN|0.0096||||95.0|-0.491|-0.114|||ANCOVA|||"The non-inferiority margin for HbA1c was set to 0.4%.~The null hypothesis (H0) was:~H0: HbA1c of repaglinide + metformin therapy after 16 weeks of treatment - HbA1c of repaglinide monotherapy after 16 weeks of treatment ≥0.4%~Against the alternative hypothesis (H1):~H1: HbA1c of repaglinide + metformin therapy after 16 weeks of treatment - HbA1c of repaglinide monotherapy after 16 weeks of treatment \<0.4%"||-0.114|-0.491|
71032929|NCT00119015|141575213|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8
70973885|NCT02004873|141454955|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin is 0.35. The Micra sensor indicated rate is considered proportional to the workload if the 90% CI for the Kay-Wilkoff slope parameter falls into \[0.65, 1.35\].|Slope|0.864|||<|0.001|TWO_SIDED|90.0|0.768|0.961||Holm adjustment for multiple comparisons for secondary objectives was used. Two One-sided Test (TOST) procedure was used at the 0.05 significance level.|t-test, 1 sided|Two One-sided Test (TOST)|A random effect linear regression model was used to assess if the Micra sensor-indicated rate was proportional to the workload using the Kay-Wilkoff model. The Kay-Wilkoff slope parameter was estimated along with its 90% CI.|Null hypothesis: Kay-Wilkoff slope parameter is \< 0.65 or \> 1.35 Alternative hypothesis: Kay-Wilkoff slope parameter is between 0.65 and 1.35||0.961|0.768|<0.001
70973886|NCT00866307|141454960|SUPERIORITY_OR_OTHER_LEGACY||Percentage|50.0|||||TWO_SIDED|90.0|35.6|64.4|||Agresti-Coull Confidence Interval|||Per protocol, percentage of high risk-High patients taking less than 49 weeks from day 1 of consolidation to day 1 of maintenance therapy is compared to a null fixed rate (\<=73%). A 90% two-sided Agresti-Coull confidence interval will be constructed and the lower bound examined. Will reject null if lower bound of confidence interval is above 73%.||64.4|35.6|
71032930|NCT00119015|141575214|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.70
71032931|NCT00119015|141575215|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.86
70973887|NCT00866307|141454961|SUPERIORITY_OR_OTHER_LEGACY||Percentage|53.3|||||TWO_SIDED|90.0|38.7|67.4|||Agresti-Coull Confidence Interval|||Per protocol, percentage receiving at least 8 doses is compared to a null fixed rate (\<=42%). A 90% two-sided Agresti-Coull confidence interval will be constructed. Will reject null if lower bound of confidence interval is above 42%.||67.4|38.7|
71032932|NCT00119015|141575216|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.48
71032933|NCT00119015|141575217|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Wilcoxon (Mann-Whitney)|||||||>0.99
71032934|NCT03235739|141575220|SUPERIORITY|multiple imputation for longitudinal data was conducted to impute the missing data for the primary outcome. The final results were obtained from pooling results from 10 imputed complete case data set.|geometric mean ratio|0.9||||0.84|TWO_SIDED|95.0|0.32|2.55|||Mixed Models Analysis|||||2.55|0.32|0.84
71032935|NCT03235739|141575220|SUPERIORITY|A sensitivity analysis using complete case analysis|geometric mean ratio|0.82||||0.73|TWO_SIDED|95.0|0.26|2.56|||Mixed Models Analysis|||||2.56|0.26|0.73
71032936|NCT03235739|141575221|SUPERIORITY||geometric mean ratio|1.02||||0.91|TWO_SIDED|98.3|0.63|1.67|||Mixed Models Analysis|||||1.67|0.63|0.91
71032937|NCT03235739|141575222|SUPERIORITY||Risk Ratio (RR)|2.58||||0.012|TWO_SIDED|98.3|0.98|6.8|||Chi-squared|||||6.80|0.98|0.012
71032938|NCT03235739|141575223|SUPERIORITY||median of differences|-5.0||||0.08|TWO_SIDED|98.3|-12.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|-12|0.08
71032939|NCT00834522|141575228|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|103.79||||||90.0|99.4|108.37|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||108.37|99.40|
71095026|NCT05537571|141698128|SUPERIORITY||Mean Difference (Final Values)|-8.6|||=|0.0013|TWO_SIDED|95.0|-13.85|-3.44|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-3.44|-13.85|=0.0013
71154131|NCT03062358|141800874|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0032|TWO_SIDED|95.0|0.6|0.92||Log-rank test|One-sided p-value|Stratified by macrovascular invasion, α-Fetoprotein and region with all cells that correspond to macrovascular invasion=Yes combined|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate||Stratified by macrovascular invasion (Yes vs. No), α-Fetoprotein (ng/mL) (\< 200 vs. ≥ 200) and region (China vs. ex-China) with all cells that correspond to macrovascular invasion=Yes combined.|0.92|0.60|0.0032
71154132|NCT03062358|141800875|OTHER||Percent Difference|11.4||||4e-05|TWO_SIDED|95.0|6.7|16.0|||One-sided p-value for testing|H0: difference in % =0 versus H1: difference in % \> 0.|Difference in % vs Placebo|Difference in % vs Placebo|Based on Miettinen \& Nurminen method stratified by macrovascular invasion (Yes vs. No), α-Fetoprotein (ng/mL) (\< 200 vs. \>= 200) and region (China vs. ex-China) with all cells that correspond to macrovascular invasion=Yes combined.|16.0|6.7|0.00004
71154133|NCT03062358|141800877|OTHER||Percent Difference|5.4||||0.13281|TWO_SIDED|95.0|-4.1|14.8|||One-sided p-value for testing|H0: difference in % =0 versus H1: difference in % \> 0.|Difference in % vs Placebo|Difference in % vs Placebo|Based on Miettinen \& Nurminen method stratified by macrovascular invasion (Yes vs. No), α-Fetoprotein (ng/mL) (\< 200 vs. ≥ 200) and region (China vs. ex-China) with all cells that correspond to macrovascular invasion=Yes combined.|14.8|-4.1|0.13281
71154134|NCT03062358|141800878|OTHER||Hazard Ratio (HR)|0.72||||0.0019|TWO_SIDED|95.0|0.58|0.9||Log-rank test|One-sided p-value|Stratified by macrovascular invasion, α-Fetoprotein and region with all cells that correspond to macrovascular invasion=Yes combined|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate||Stratified by macrovascular invasion (Yes vs. No), α-Fetoprotein (ng/mL) (\< 200 vs. ≥ 200) and region (China vs. ex-China) with all cells that correspond to macrovascular invasion=Yes combined.|0.90|0.58|0.0019
71154135|NCT03861273|141800889|NON_INFERIORITY|A repeated measure negative binomial regression model was used to do the hypothesis test on non-inferiority with one-sided test.|Mean Difference (Final Values)|-3.13||||0.0081|TWO_SIDED|95.0|-5.44|-0.81|||Generalized linear model (GLM)|The treatment difference and P-value were obtained from a repeated measures GLM with negative binomial distribution and identity link function.||||-0.81|-5.44|0.0081
71154136|NCT03861273|141800890|NON_INFERIORITY|A repeated measure negative binomial regression model was used to do the hypothesis test on non-inferiority with one-sided test.|Median Difference (Final Values)|-2.62||||0.0019|TWO_SIDED|95.0|-4.27|-0.96|||Generalized linear model (GLM)|The treatment difference and P-value were obtained from a repeated measures GLM with negative binomial distribution and identity link function.||||-0.96|-4.27|0.0019
71154137|NCT03861273|141800891|SUPERIORITY||Mean Difference (Final Values)|-54.37|||<|0.0001|TWO_SIDED|95.0|-63.64|-45.1|||Paired t-test|||The treatment difference (PF-06838435 - FIX Prophylaxis) estimate (95% CI) and p-value were obtained from paired t-test.||-45.10|-63.64|<.0001
70973888|NCT01060059|141454979|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.831|TWO_SIDED|95.0|0.62|1.46|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if Baseline Gender (Male vs. Female), was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.46|0.62|0.831
71154138|NCT03861273|141800892|OTHER||||||<|0.0001||||||P-value from one-sided t-statistic testing the log transformation of the steady state FIX:C \> log(5). Cumulative for 3 assays.|One-sided t-statistic testing|||Week 12 to Month 15||||<.0001
70973889|NCT01060059|141454979|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.554|TWO_SIDED|95.0|0.74|1.76||Baseline Medical conditions (yes vs. no)|Regression, Logistic|||Logistic regression analysis was used to find factors associated with treatment choice at baseline. Covariates with more than 30% observations missing are omitted in this analysis. Weight was removed (high correlation with BMI) and also fasting blood glucose (lab value) was removed (high correlation with HbA1c). Missing values for remaining numeric covariates were replaced with means, and for categorical ones-with modes.||1.76|0.74|0.554
71154139|NCT03861273|141800894|SUPERIORITY||Mean Difference (Final Values)|-2935.7|||<|0.0001|TWO_SIDED|95.0|-3403.1|-2468.3|||Paired t-test|||||-2468.30|-3403.10|<.0001
71154140|NCT03861273|141800895|NON_INFERIORITY|The treatment difference and P-value were obtained from a repeated measures GLM with negative binomial distribution and identity link function.|Mean Difference (Final Values)|-2.55||||0.0191|TWO_SIDED|95.0|-4.67|-0.42|||Generalized linear model (GLM)|||||-0.42|-4.67|0.0191
71154141|NCT03861273|141800896|NON_INFERIORITY|The treatment difference and P-value were obtained from a repeated measures GLM with negative binomial distribution and identity link function.|Median Difference (Final Values)|-0.57||||0.1528|TWO_SIDED|95.0|-1.35|0.21|||Generalized linear model (GLM)|||||0.21|-1.35|0.1528
71154142|NCT03861273|141800897|NON_INFERIORITY|The treatment difference and P-value were obtained from a repeated measures GLM with negative binomial distribution and identity link function.|Mean Difference (Final Values)|-0.51||||0.3738|TWO_SIDED|95.0|-1.63|0.61|||Generalized linear model (GLM)|||||0.61|-1.63|0.3738
71154143|NCT03861273|141800900|OTHER|||||||0.0117|||||||Paired t-test|||||||0.0117
71154144|NCT03861273|141800901|OTHER|||||||0.0052|||||||Paired t-test|||||||0.0052
70973890|NCT01060059|141454979|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.714|TWO_SIDED|95.0|0.43|3.42||Baseline gastrointestinal symptoms (yes vs. no)|Regression, Logistic|||Logistic regression analysis was used to find factors associated with treatment choice at baseline. Covariates with more than 30% observations missing are omitted in this analysis. Weight was removed (high correlation with BMI) and also fasting blood glucose (lab value) was removed (high correlation with HbA1c). Missing values for remaining numeric covariates were replaced with means, and for categorical ones-with modes.||3.42|0.43|0.714
71095027|NCT05537571|141698128|SUPERIORITY||Mean Difference (Final Values)|-14.0|||<|0.0001|TWO_SIDED|95.0|-19.2|-8.84|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-8.84|-19.2|<0.0001
70973891|NCT01060059|141454980|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69|||<|0.001|TWO_SIDED|95.0|0.6|0.78|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if Baseline HbA1c was 1% more, was it associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||0.78|0.60|<0.001
70973892|NCT01060059|141454981|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.055|TWO_SIDED|95.0|0.96|1.0|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if longer duration of diabetes was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.00|0.96|0.055
70973893|NCT01060059|141454982|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97|||<|0.001|TWO_SIDED|95.0|0.95|0.99|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if older age (1 year older), was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||0.99|0.95|<0.001
70973894|NCT01060059|141454983|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19|||<|0.001|TWO_SIDED|95.0|1.15|1.23|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if higher BMI (1 kg/m\^2 higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.23|1.15|<0.001
70973895|NCT01060059|141454984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.026|TWO_SIDED|95.0|1.0|1.05|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if greater height (1 cm higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.05|1.00|0.026
70973896|NCT01060059|141454985|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.37||||0.007|TWO_SIDED|95.0|0.18|0.77|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if higher baseline creatinine (1mg/dL higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||0.77|0.18|0.007
70973897|NCT01060059|141454985|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.094|TWO_SIDED|95.0|0.97|1.0|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if higher baseline fasting HDL cholesterol (1mg/dL higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.00|0.97|0.094
70973898|NCT01060059|141454985|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.259|TWO_SIDED|95.0|1.0|1.01|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if higher baseline fasting total cholesterol (1mg/dL higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.01|1.00|0.259
70973899|NCT01060059|141454985|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.123|TWO_SIDED|95.0|1.0|1.0|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if higher baseline fasting triglycerides (1mg/dL higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.00|1.00|0.123
71008740|NCT02055976|141525249|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.563|STANDARD_ERROR_OF_MEAN|11.067||0.221|TWO_SIDED|95.0|-30.554|13.427|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||13.427|-30.554|0.221
71095028|NCT05537571|141698129|SUPERIORITY||Mean Difference (Final Values)|-11.3|||<|0.0001|TWO_SIDED|95.0|-16.81|-5.73|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-5.73|-16.81|<0.0001
71095029|NCT05537571|141698129|SUPERIORITY||Mean Difference (Final Values)|-7.2|||=|0.0106|TWO_SIDED|95.0|-12.64|-1.69|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-1.69|-12.64|=0.0106
71154145|NCT03861273|141800902|OTHER|||||||0.0237|||||||Paired t-test|||||||0.0237
70973900|NCT00848354|141454987|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel chi-square test, stratified by country, was used to calculate p-value. Assuming ACR50 response at Week 24 to be 23% in the DMARD combination therapy group and 37% in the etanercept + methotrexate group, a study enrolling 276 participants assigned to etanercept + methotrexate and 138 participants assigned to DMARD combination therapy has 80% power to reject the null hypothesis of no difference in response rates testing at the type I error = 0.05 level.||||<0.0001
70973901|NCT00848354|141454988|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||Analysis of covariance (ANCOVA) model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value.||||<0.0001
70973902|NCT00848354|141454989|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for vitality domain at Week 24.||||0.0003
70973903|NCT00848354|141454989|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for mental component at Week 24.||||0.0002
70973904|NCT00848354|141454989|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for physical component at Week 24.||||<0.0001
70973905|NCT00848354|141454990|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model on ranks of change in mTSS with treatment group and center main effects and the Baseline rank as covariate was used to calculate p-value.||||0.0270
70973906|NCT00848354|141454991|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
70973907|NCT00848354|141454994|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.39|||<|0.0001|TWO_SIDED|95.0|2.25|18.2||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||18.2|2.25|<0.0001
70973908|NCT00848354|141454994|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.99|||<|0.0001|TWO_SIDED|95.0|2.62|9.49||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||9.49|2.62|<0.0001
70973909|NCT00848354|141454994|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.6|||<|0.0001|TWO_SIDED|95.0|2.19|5.94||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||5.94|2.19|<0.0001
70973910|NCT00848354|141454994|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1|||<|0.0001|TWO_SIDED|95.0|2.57|6.53||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||6.53|2.57|<0.0001
70973911|NCT00848354|141454994|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.93|||<|0.0001|TWO_SIDED|95.0|2.51|6.16||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||6.16|2.51|<0.0001
70973912|NCT00848354|141454994|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.82|||<|0.0001|TWO_SIDED|95.0|2.46|5.93||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||5.93|2.46|<0.0001
70973913|NCT00848354|141454994|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.39|||<|0.0001|TWO_SIDED|95.0|3.41|8.53||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||8.53|3.41|<0.0001
71095030|NCT05537571|141698129|SUPERIORITY||Mean Difference (Final Values)|-12.6|||<|0.0001|TWO_SIDED|95.0|-18.04|-7.15|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-7.15|-18.04|<0.0001
71095031|NCT05537571|141698130|SUPERIORITY||Mean Difference (Final Values)|-31.9|||=|0.0051|TWO_SIDED|95.0|-54.07|-9.72|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-9.72|-54.07|=0.0051
71154146|NCT03799341|141800928|OTHER|||||||0.177|||||||Wilcoxon (Mann-Whitney)|||||||0.177
71154147|NCT03799341|141800929|OTHER|||||||0.033|||||||Wilcoxon (Mann-Whitney)|||||||0.033
71154148|NCT03799341|141800930|OTHER|||||||0.126|||||||Wilcoxon (Mann-Whitney)|||||||0.126
71154149|NCT03799341|141800931|OTHER|||||||0.384|||||||Wilcoxon (Mann-Whitney)|||||||0.384
71154150|NCT03799341|141800932|OTHER|||||||0.308|||||||Wilcoxon (Mann-Whitney)|||||||0.308
71154151|NCT03799341|141800933|OTHER|||||||0.976|||||||Wilcoxon (Mann-Whitney)|||||||0.976
71154152|NCT03799341|141800934|OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.920
71032940|NCT00834522|141575229|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|104.37||||||90.0|97.04|112.25|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||112.25|97.04|
71032941|NCT00834522|141575230|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|104.22||||||90.0|96.9|112.08|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||112.08|96.90|
71032942|NCT00834249|141575231|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|101.73||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.|||||
71032943|NCT00834249|141575232|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|99.73||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.|||||
71032944|NCT00834249|141575233|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|99.71||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.|||||
71032945|NCT00834249|141575234|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|109.61||||||90.0|||||||Metabolite results not subjected to bioequivalence criteria, results are presented for informational purposes only.|||||
71032946|NCT00834249|141575235|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|106.85||||||90.0|||||||Metabolite results not subjected to bioequivalence criteria, results are presented for informational puposes only.|||||
71032947|NCT00834249|141575236|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|106.38||||||90.0|||||||Metabolite results not subjected to bioequivalence criteria, results are presented for informational purposes only.|||||
71032948|NCT05025345|141575267|NON_INFERIORITY|Noninferiority margin equals -0.1|Mean Difference (Final Values)|-0.013|||||TWO_SIDED|90.0|-0.036|0.011||Success criteria was evaluated using lower confidence interval. No P-Value was calculated.||||||0.011|-0.036|
71154153|NCT03799341|141800935|OTHER|||||||0.873|||||||Wilcoxon (Mann-Whitney)|||||||0.873
71032949|NCT05025345|141575268|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
71032950|NCT02246920|141575281|EQUIVALENCE|Equivalence is established if the 90% confidence interval is contained within 80.00-125.00%.|T/R Ls Mean Ratio|108.09|||||TWO_SIDED|90.0|94.09|124.4||||||||124.40|94.09|
71032951|NCT02246920|141575282|EQUIVALENCE|Equivalence is demonstrated when the 90% confidence interval is contained within 80.00-125.00%.|T/R LS Mean Ratio|107.0|||||TWO_SIDED|90.0|92.42|124.09||||||||124.09|92.42|
71095032|NCT05537571|141698130|SUPERIORITY||Mean Difference (Final Values)|-29.7|||=|0.0081|TWO_SIDED|95.0|-51.62|-7.81|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-7.81|-51.62|=0.0081
71032952|NCT02246920|141575283|SUPERIORITY|||||||0.0028|||||||ANCOVA|||||||0.0028
71032953|NCT02246920|141575283|SUPERIORITY|||||||0.0169|||||||ANCOVA|||||||0.0169
71032954|NCT00904215|141575360|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Student Paired t-test|||||||<0.0001
71032955|NCT00904215|141575361|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Student Paired t-test|||||||<0.0001
71032956|NCT00904215|141575362|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Student Paired t-test|||||||<0.0001
71032957|NCT00904215|141575363|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Student Paired t-test|||||||<0.0001
71032958|NCT01299454|141575373|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.166|||||TWO_SIDED|90.0|0.776|1.751|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% confidence interval (CI) for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.751|0.776|
71032959|NCT01299454|141575373|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.375|||||TWO_SIDED|90.0|0.915|2.066|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||2.066|0.915|
71095033|NCT05537571|141698130|SUPERIORITY||Mean Difference (Final Values)|-25.1|||=|0.0241|TWO_SIDED|95.0|-46.89|-3.33|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-3.33|-46.89|=0.0241
71154154|NCT03799341|141800936|OTHER||||||<|0.001|||||||ANOVA|||Due to violations of normality assumptions, a non-parametric Aligned Rank Transform ANOVA was conducted, which does not permit inclusion of covariates. A median split approach was therefore used to examine the influence of Contingency Management session attendance. The design included 4 factors: time (2 levels), stimulus condition (3 levels), electrode pair (4 levels), and median split group membership (2 levels). Reported results reflect the interaction between time and median split group.||||<0.001
71095034|NCT05537571|141698131|SUPERIORITY||Mean Difference (Final Values)|-29.8|||=|0.0023|TWO_SIDED|95.0|-48.86|-10.76|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-10.76|-48.86|=0.0023
71095035|NCT05537571|141698131|SUPERIORITY||Mean Difference (Final Values)|-27.4|||=|0.0046|TWO_SIDED|95.0|-46.23|-8.58|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-8.58|-46.23|=0.0046
71095036|NCT05537571|141698131|SUPERIORITY||Mean Difference (Final Values)|-26.0|||=|0.0068|TWO_SIDED|95.0|-44.67|-7.24|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-7.24|-44.67|=0.0068
71095037|NCT05537571|141698132|SUPERIORITY||Mean Difference (Final Values)|-28.7|||=|0.0057|TWO_SIDED|95.0|-48.91|-8.46|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-8.46|-48.91|=0.0057
71095038|NCT05537571|141698132|SUPERIORITY||Mean Difference (Final Values)|-26.1|||||TWO_SIDED|95.0|-46.13|-6.16||||||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-6.16|-46.13|
71095039|NCT05537571|141698132|SUPERIORITY||Mean Difference (Final Values)|-24.1||||0.0179|TWO_SIDED|95.0|-43.93|-4.2|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-4.2|-43.93|0.0179
71095040|NCT05494632|141698133|SUPERIORITY||Median Difference (Net)|1.0|||<|0.001|TWO_SIDED|||||the threshold for statistical significance was \<=0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
71095041|NCT01059851|141698230|NON_INFERIORITY_OR_EQUIVALENCE|"AUC(0-∞) GMR = AUC(0-∞) GM for Severe Renal Impairment Participants ÷ AUC(0-∞) GM for Healthy Participants.~A 90% CI for the AUC(0-∞) GMR was computed from the ANCOVA model. As prespecified by the analysis plan, if the 90% CI for the AUC(0-∞) GMR was contained within the interval \[0.50, 2.00\], then the hypothesis would be met and the AUC(0-∞) of suvorexant would be similar in both groups of participants. That is, if the true ratio of the GM AUC(0-∞) is greater than 0.50 and no more than 2.00."|AUC(0-∞) Geometric Mean Ratio|1.22|||||TWO_SIDED|90.0|0.93|1.6|||ANCOVA|||"The geometric mean (GM) for each participant group and the corresponding 95% confidence interval (CI) were calculated for AUC(0-∞) using an analysis of covariance (ANCOVA) model.~The AUC(0-∞) geometric mean ratio (GMR) of the 2 participant groups was used to test the primary hypothesis, which was that the AUC(0-∞) of suvorexant following a single oral dose would be similar between participants with renal impairment and healthy matched control participants."||1.60|0.93|
71095042|NCT00223821|141698238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.2|STANDARD_ERROR_OF_MEAN|7.65||0.16|TWO_SIDED|95.0|-5.13|25.54|||ANCOVA|ANCOVA, with baseline frequency of incontinent episodes as the covariate, was used to compare the treatment groups.||The effectiveness of each intervention was calculated by comparing the weekly frequency of incontinent episodes (derived from seven-day bladder diaries) during baseline to that in the immediate post-intervention period (week 8). The primary analysis was based on intent-to-treat, in which post-treatment frequency of incontinence for non-completers was derived from the most recent week of diaries.||25.54|-5.13|.16
71095043|NCT00223821|141698239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8|STANDARD_ERROR_OF_MEAN|8.71||0.37|TWO_SIDED|95.0|-10.73|24.33|||ANCOVA|ANCOVA, with baseline frequency of incontinent episodes as the covariate, was used to compare the treatment groups.||||24.33|-10.73|.37
71154155|NCT03799341|141800936|OTHER||||||<|0.001|||||||ANOVA|||Due to violations of normality assumptions, a non-parametric Aligned Rank Transform ANOVA was conducted, which does not permit covariates. A median split approach was therefore used to examine the influence of self-reported cocaine abstinence during treatment. The design included 4 factors: time (2 levels), stimulus condition (3 levels), electrode pair (4 levels), and median split group membership (2 levels). Reported results reflect the interaction between time and median split group.||||<0.001
71095044|NCT01039675|141698240|NON_INFERIORITY_OR_EQUIVALENCE|UMEC/VI will be declared non-inferior to placebo in terms of weighted mean pulse rate if the upper limit of the 95% confidence interval around the estimated treatment difference for weighted mean pulse rate is less than the non-inferiority margin of +10bpm.|Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-5.5|4.5|||||Estimated from repeated measures analysis of covariance.|||4.5|-5.5|
71095045|NCT03712852|141698333|SUPERIORITY||Mean Difference (Net)|0.92|||||TWO_SIDED|95.0|0.68|1.17|||||||Multiple univariate analyses for each variable were performed. GT was analyzed by non-parametric Cliff's delta tests to assess group dominance and by a Heteroscedastic ANOVA with Games-Howell posthoc tests. A sensitivities analysis with different types of robust analyses (M-estimators and High Breakdown LTS Estimators, both with Huber's, Hampel's and Biweight's loss functions) was conducted to get an effect-size estimate by means of Bootstrap Bias Corrected and accelerated (BCa) 95% Confidence Intervals.|1.17|0.68|
71095046|NCT03712852|141698334|SUPERIORITY||Median Difference (Final Values)|3.28|||||TWO_SIDED|95.0|3.0|3.55|||||||This outcome was analyzed by posthoc Nemenyi's tests|3.55|3.00|
71095047|NCT03712852|141698335|SUPERIORITY||Mean Difference (Final Values)|0.08|||||TWO_SIDED|95.0|-0.46|2.46|||||||This outcome was analyzed by posthoc Nemenyi's tests|2.46|-0.46|
71095048|NCT03712852|141698336|SUPERIORITY||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.4|0.69|||||||This outcome was analyzed by posthoc Nemenyi's tests|0.69|-0.40|
71095049|NCT03712852|141698337|SUPERIORITY||Mean Difference (Final Values)|3.38|||||TWO_SIDED|95.0|2.96|3.81|||||||CAL was analyzed with both Nemenyi's tests and a Moderated Regression (Treatment by Baseline values)|3.81|2.96|
71095050|NCT00138294|141698364|OTHER||Incidence Rate Ratio|0.89|||||TWO_SIDED|95.0|0.87|0.91||||||Overall Effectiveness against MAARI during the Epidemic Period (2007-2008)||0.91|0.87|
71095051|NCT00138294|141698365|OTHER||Incidence Rate Ratio|0.69|||||TWO_SIDED|95.0|0.67|0.71||||||Overall Effectiveness against MAARI during the Epidemic Period (2008-2009)||0.71|0.67|
71095052|NCT00138294|141698366|OTHER||Incidence Rate Ratio|0.75|||||TWO_SIDED|95.0|0.73|0.76||||||Overall Effectiveness against MAARI during the Epidemic Period (2008-2009)||0.76|0.73|
70973914|NCT00848354|141454996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.84|||<|0.0001|TWO_SIDED|95.0|2.37|6.21||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||6.21|2.37|<0.0001
70973915|NCT00848354|141454996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.34|||<|0.0001|TWO_SIDED|95.0|2.19|5.11||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||5.11|2.19|<0.0001
70973916|NCT00848354|141454996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9|||<|0.0001|TWO_SIDED|95.0|1.9|4.43||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||4.43|1.90|<0.0001
70973917|NCT00848354|141454996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.2|||<|0.0001|TWO_SIDED|95.0|2.06|4.96||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||4.96|2.06|<0.0001
70973918|NCT00848354|141454996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.91|||<|0.0001|TWO_SIDED|95.0|2.46|6.21||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||6.21|2.46|<0.0001
71095053|NCT04764539|141698377|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_DEVIATION|0.294|<|0.555|TWO_SIDED|95.0|-1.276|0.796||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group - iPad Pro group)|The Mean Length of Utterance (MLU) will not increase from baseline for the either the iPad Pro or VR goggle participant group after having used the VAST system for 2 months.||0.796|-1.276|<0.555
70973919|NCT00848354|141454996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.9|||<|0.0001|TWO_SIDED|95.0|2.45|6.22||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||6.22|2.45|<0.0001
70973920|NCT00848354|141454996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.94|||<|0.0001|TWO_SIDED|95.0|3.13|7.78||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||7.78|3.13|<0.0001
70973921|NCT00848354|141454998|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.19||||0.1086|TWO_SIDED|95.0|0.66|40.9||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||40.9|0.66|0.1086
70973922|NCT00848354|141454998|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.58||||0.0392|TWO_SIDED|95.0|1.04|12.3||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||12.3|1.04|0.0392
70973923|NCT00848354|141454998|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.27|||<|0.0001|TWO_SIDED|95.0|2.04|13.6||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||13.6|2.04|<0.0001
71032960|NCT01299454|141575373|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.929|||||TWO_SIDED|90.0|0.581|1.488|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.488|0.581|
70973924|NCT00848354|141454998|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.69|||<|0.0001|TWO_SIDED|95.0|2.39|13.6||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||13.6|2.39|<0.0001
70973925|NCT00848354|141454998|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.78|||<|0.0001|TWO_SIDED|95.0|2.02|7.09||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||7.09|2.02|<0.0001
70973926|NCT00848354|141454998|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.65|||<|0.0001|TWO_SIDED|95.0|2.02|6.6||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||6.60|2.02|<0.0001
70973927|NCT00848354|141454998|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.2|||<|0.0001|TWO_SIDED|95.0|2.36|7.46||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||7.46|2.36|<0.0001
70973928|NCT00848354|141455000|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
70973929|NCT00848354|141455002|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.23|||<|0.0001|TWO_SIDED|95.0|3.88|10.0||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value.||10.00|3.88|<0.0001
71032961|NCT01299454|141575374|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometic Mean Ratio|1.255|||||TWO_SIDED|90.0|0.702|2.244|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% confidence interval (CI) for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||2.244|0.702|
71032962|NCT01299454|141575374|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.727|||||TWO_SIDED|90.0|0.977|3.052|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||3.052|0.977|
71032963|NCT01299454|141575374|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometic Mean Ratio|1.041|||||TWO_SIDED|90.0|0.506|2.142|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance||2.142|0.506|
71032964|NCT01299454|141575375|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.904|||||TWO_SIDED|90.0|0.707|1.156|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance||1.156|0.707|
71032965|NCT01299454|141575375|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.85|||||TWO_SIDED|90.0|0.665|1.087|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance||1.087|0.665|
71095054|NCT04764539|141698377|SUPERIORITY||Mean Difference (Final Values)|0.5383|STANDARD_DEVIATION|0.659|<|0.2128|TWO_SIDED|95.0|-0.471|1.548||Sample size is too small for statistical power.|ANOVA||Difference = (iPad Pro group Post-Treatment - iPad Pro group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||1.548|-0.471|<0.2128
71095055|NCT04764539|141698377|SUPERIORITY||Mean Difference (Final Values)|0.298|STANDARD_DEVIATION|0.365|<|0.533|TWO_SIDED|95.0|-0.915|1.511||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group Post-Treatment - VR goggles group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||1.511|-0.915|<0.533
71095056|NCT04764539|141698378|SUPERIORITY||Mean Difference (Final Values)|1.388|STANDARD_DEVIATION|1.7|<|0.289|TWO_SIDED|95.0|-1.763|4.539||Sample size too small for statistical power. In addition, automated speech recognition for child speech had a very poor state-of-the-art at the time of this study.|ANOVA||Difference = (iPad Pro group - VR goggles group)|The percentage of correctly transcribed words using automatic speech recognition will not increase from baseline for the either the iPad Pro or VR goggle participant group after having used the VAST system for 2 months.||4.539|-1.763|<0.289
71095057|NCT04764539|141698379|SUPERIORITY||Mean Difference (Final Values)|-3.51|STANDARD_DEVIATION|4.3||0.4296|TWO_SIDED|95.0|-49.68|42.66||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group - iPad Pro group)|Articulation Accuracy does not statistically differ for the iPad Pro or VR goggle participant group after having used the VAST system for 2 months.||42.66|-49.68|0.4296
70921048|NCT04583423|141333260|OTHER||Difference in Percentages|1.6||||0.8978|TWO_SIDED|95.0|-26.5|30.3|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 50 mg minus % Placebo|||30.3|-26.5|0.8978
70921049|NCT04583423|141333260|OTHER||Difference in Parentages|20.0||||0.1869|TWO_SIDED|95.0|-10.6|46.4|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 100 mg minus % Placebo|||46.4|-10.6|0.1869
70921050|NCT04583423|141333260|OTHER||Difference in Percentages|8.5||||0.5636|TWO_SIDED|95.0|-22.1|38.5|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 300 mg minus % Placebo|||38.5|-22.1|0.5636
71032966|NCT01299454|141575375|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.531||||||90.0|0.399|0.705|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% confidence interval (CI) for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance||0.705|0.399|
71095058|NCT04764539|141698379|SUPERIORITY||Mean Difference (Final Values)|19.75|STANDARD_DEVIATION|24.19|<|0.294|TWO_SIDED|95.0|-25.7|65.2||Sample size is too small for statistical power.|ANOVA||Difference = (iPad Pro group Post-Treatment - iPad Pro group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||65.2|-25.7|<0.294
71095059|NCT04764539|141698379|SUPERIORITY||Mean Difference (Final Values)|16.25|STANDARD_DEVIATION|19.9|<|0.419|TWO_SIDED|95.0|-33.86|66.36||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group Post-Treatment - VR goggles group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||66.36|-33.86|<0.419
70921051|NCT04583423|141333261|OTHER||Difference in Percentages|1.6||||0.9174|TWO_SIDED|95.0|-28.6|32.6|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 50 mg minus % Placebo|||32.6|-28.6|0.9174
70921052|NCT04583423|141333261|OTHER||Difference in Percentages|18.5||||0.272|TWO_SIDED|95.0|-14.5|47.1|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 100 mg minus % Placebo|||47.1|-14.5|0.2720
70921053|NCT04583423|141333261|OTHER||Difference in Percentages|5.3||||0.7586|TWO_SIDED|95.0|-26.7|37.3|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference= % 300 mg minus % Placebo|||37.3|-26.7|0.7586
70921054|NCT03351699|141333262|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).|Posterior Mean Difference|-1.53|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-4250 and placebo at least 1.4 log10 copies/mL was 78%.|||||
70921055|NCT03351699|141333262|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).|Posterior Mean Difference|-1.73|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-4250 and placebo at least 1.4 log10 copies/mL was 95%.|||||
70921056|NCT03351699|141333262|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).|Posterior Mean Difference|-1.52|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-4250 and placebo at least 1.4 log10 copies/mL was 75%.|||||
70921057|NCT03351699|141333262|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).|Posterior Mean Difference|-1.75|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-4250 and placebo at least 1.4 log10 copies/mL was 96%.|||||
70921058|NCT00603954|141333307|SUPERIORITY|||||||0.508|||||||Multivariate Cox models|||||||0.508
70921059|NCT00603954|141333307|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||At day 180||||0.02
70921060|NCT00603954|141333307|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||At Day 365||||0.002
70921061|NCT00603954|141333308|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||At day 100||||0.09
70921062|NCT00603954|141333308|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||At Day 40||||0.03
70921063|NCT00603954|141333308|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||At Day 180||||0.01
70921064|NCT00603954|141333309|SUPERIORITY|||||||0.0165|||||||Multivariate Cox models|||||||0.0165
70921065|NCT00603954|141333309|SUPERIORITY||Hazard Ratio (HR)|0.3||||0.01|TWO_SIDED|95.0|||||Mutivariate|||||||0.010
70921066|NCT00603954|141333309|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.0495|TWO_SIDED|95.0|||||Multivariate|||||||0.0495
70921067|NCT00603954|141333309|SUPERIORITY||Hazard Ratio (HR)|3.8||||0.001|TWO_SIDED|95.0|||||Multivariate|||||||0.001
70921068|NCT00603954|141333310|SUPERIORITY|||||||0.15|||||||Fisher Exact|||19 of 49 Flu-TBI patients (39%) versus 25 of 45 TLI ATG patients (56%) had a least one episode of bacterial infection the first 100 days after transplantation (P = 0.15).||||0.15
70921069|NCT00603954|141333310|SUPERIORITY|||||||0.19|||||||Fisher Exact|||For fungal infections, the figures were 3 of 45 (6%) and 7 of 45 (16%), respectively (P = 0.19)||||0.19
71095060|NCT04764539|141698380|SUPERIORITY||Mean Difference (Final Values)|1.33|STANDARD_DEVIATION|1.63|<|0.659|TWO_SIDED|95.0|-6.436|9.096||Sample size to small for statistical power.|ANOVA||difference = (iPad group mean - VR goggles group mean)|||9.096|-6.436|<0.659
71095061|NCT04764539|141698381|SUPERIORITY||Mean Difference (Final Values)|7.9|STANDARD_DEVIATION|9.67|<|0.789|TWO_SIDED|95.0|-68.91|84.7|||ANOVA|Sample size too small for statistical power.|Difference = (iPad Pro group - VR Goggles group)|||84.7|-68.91|<0.789
71095062|NCT04764539|141698381|SUPERIORITY||Mean Difference (Final Values)|30.16|STANDARD_DEVIATION|36.94|<|0.304|TWO_SIDED|95.0|-40.85|101.17||Sample size is too small for statistical power.|ANOVA||Difference = (iPad Pro group Post-Treatment - iPad Pro group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||101.17|-40.85|<0.304
71095063|NCT04764539|141698381|SUPERIORITY||Mean Difference (Final Values)|22.26|STANDARD_DEVIATION|27.26|<|0.403|TWO_SIDED|95.0|-43.91|88.43||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group Post-Treatment - VR goggles group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||88.43|-43.91|<0.403
71095064|NCT04764539|141698382|SUPERIORITY||Mean Difference (Final Values)|-2.34|STANDARD_DEVIATION|2.87|<|0.485|TWO_SIDED|95.0|-10.79|6.11||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group - iPad Pro group)|The response to treatment stimuli will not increase from baseline for the either the iPad Pro or VR goggle participant group after having used the VAST system for 2 months.||6.11|-10.79|<0.485
71095065|NCT04764539|141698382|SUPERIORITY||Mean Difference (Final Values)|5.66|STANDARD_DEVIATION|6.94|<|0.065|TWO_SIDED|95.0|-0.569|11.9||Sample size is too small for statistical power.|ANOVA||Difference = (iPad Pro group Post-Treatment - iPad Pro group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||11.9|-0.569|<0.065
71095066|NCT04764539|141698382|SUPERIORITY||Mean Difference (Final Values)|3.34|STANDARD_DEVIATION|4.09|<|0.549|TWO_SIDED|95.0|-10.85|17.53||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group Post-Treatment - VR goggles group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||17.53|-10.85|<0.549
70921070|NCT00603954|141333310|SUPERIORITY|||||||0.12|||||||Fisher Exact|||Among CMV-seropositive patients and/or donors, the 100-day cumulative incidence of CMV reactivation was 31% in Flu-TBI patients versus 47% in TLI-ATG patient||||0.12
70921071|NCT00603954|141333311|SUPERIORITY||Multivariate Cox models|2.3|STANDARD_DEVIATION|0.02||0.017|TWO_SIDED|95.0|1.1|4.7|||Cumulative incidence curves|||Four-year cumulative incidences of relapse/progression were 22% and 50% in Flu-TBI and TLI-ATG patients, respectively||4.7|1.1|0.017
70921072|NCT00603954|141333312|SUPERIORITY||Median Difference (Final Values)|4.0|||||TWO_SIDED|||||||||This statistical analysis applies to median ATG serum levels at day 0||||
70921073|NCT00603954|141333312|SUPERIORITY||Mean Difference (Final Values)|2.2|||||TWO_SIDED|||||||||This statistical analysis applies to median ATG serum levels at day 3||||
70921074|NCT00603954|141333312|SUPERIORITY||Mean Difference (Final Values)|0.95|||||TWO_SIDED|||||||||This statistical analysis applies to median ATG serum levels at day 10||||
70921075|NCT00603954|141333313|SUPERIORITY|||||||0.5|||||||Cumulative incidence curve|||||||0.5
70921076|NCT00603954|141333314|SUPERIORITY||multivariate analyses|2.0|STANDARD_DEVIATION|0.07||0.14|TWO_SIDED|95.0|1.0|4.1|||Kaplan-Meier method|||||4.1|1|0.14
70921077|NCT00603954|141333316|SUPERIORITY||multivariate analyses|1.2|STANDARD_DEVIATION|0.02||0.9|TWO_SIDED|95.0|1.0|1.4|||Kaplan-Meier method|||||1.4|1|0.9
70921078|NCT00603954|141333317|SUPERIORITY||multivariate analyses|1.2|STANDARD_DEVIATION|0.02||0.96|TWO_SIDED|95.0|1.0|1.4|||Kaplan-Meier method|||||1.4|1|0.96
70921079|NCT00567489|141333326|SUPERIORITY||Mean Difference (Final Values)|0.6|||<|0.001|TWO_SIDED|95.0|0.2|0.9|||ANOVA|||Month 3||0.9|0.2|<0.001
70921080|NCT00567489|141333326|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.006|TWO_SIDED|95.0|0.1|0.8|||ANOVA|||Month 6||0.8|0.1|0.006
70921081|NCT00567489|141333327|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.312|TWO_SIDED|95.0|-4.7|14.7|||ANOVA|||Insulin-Month 3||14.7|-4.7|0.312
70921082|NCT00567489|141333327|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.342|TWO_SIDED|95.0|-5.0|14.4|||ANOVA|||Insulin-Month 6||14.4|-5.0|0.342
70921083|NCT00567489|141333329|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.01|TWO_SIDED|95.0|0.1|0.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 3||0.9|0.1|0.010
70921084|NCT00567489|141333329|SUPERIORITY||Median Difference (Final Values)|0.3||||0.073|TWO_SIDED|95.0|0.0|0.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 6||0.7|0|0.073
70921085|NCT00567489|141333329|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.181|TWO_SIDED|95.0|-0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 3||0.5|-0.1|0.181
70921086|NCT00567489|141333329|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.593|TWO_SIDED|95.0|-0.2|0.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 6||0.4|-0.2|0.593
70921087|NCT00567489|141333329|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.198|TWO_SIDED|95.0|-0.2|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 3||0|-0.2|0.198
70921088|NCT00567489|141333329|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.298|TWO_SIDED|95.0|-0.1|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 6||0|-0.1|0.298
71095067|NCT02827708|141698395|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.6||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.6|-1.0|<0.0001
70973930|NCT00848354|141455003|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.79|||<|0.0001|TWO_SIDED|95.0|3.49|17.39||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value.||17.39|3.49|<0.0001
70973931|NCT00848354|141455004|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.5|||<|0.0001|TWO_SIDED|95.0|2.24|5.46||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||5.46|2.24|<0.0001
70973932|NCT00848354|141455004|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.99|||<|0.0001|TWO_SIDED|95.0|2.91|8.55||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||8.55|2.91|<0.0001
70973933|NCT00848354|141455004|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.94|||<|0.0001|TWO_SIDED|95.0|2.93|12.02||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||12.02|2.93|<0.0001
70973934|NCT00848354|141455004|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.57|||<|0.0001|TWO_SIDED|95.0|2.27|9.21||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||9.21|2.27|<0.0001
70973935|NCT00848354|141455004|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.08|||<|0.0001|TWO_SIDED|95.0|2.74|13.48||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||13.48|2.74|<0.0001
70973936|NCT00848354|141455004|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.86|||<|0.0001|TWO_SIDED|95.0|3.0|15.72||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||15.72|3.00|<0.0001
70973937|NCT00848354|141455004|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.64|||<|0.0001|TWO_SIDED|95.0|3.74|15.63||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||15.63|3.74|<0.0001
70973938|NCT00848354|141455006|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.15|||<|0.0001|TWO_SIDED|95.0|2.04|4.86||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||4.86|2.04|<0.0001
70973939|NCT00848354|141455006|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.41|||<|0.0001|TWO_SIDED|95.0|2.85|6.82||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||6.82|2.85|<0.0001
70973940|NCT00848354|141455006|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.99|||<|0.0001|TWO_SIDED|95.0|2.5|6.38||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||6.38|2.50|<0.0001
70973941|NCT00848354|141455006|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.9|||<|0.0001|TWO_SIDED|95.0|2.37|6.41||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||6.41|2.37|<0.0001
71154156|NCT03799341|141800936|OTHER|||||||0.022|||||||ANOVA|||Due to violations of normality assumptions, a non-parametric Aligned Rank Transform ANOVA was conducted, which does not permit inclusion of covariates. A median split approach was therefore used to examine the influence of Contingency Management session attendance. The design included 4 factors: time (2 levels), response accuracy (2 levels), electrode pair (4 levels), and median split group membership (2 levels). Reported results reflect the interaction between time and median split group.||||0.022
70973942|NCT00848354|141455006|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.58|||<|0.0001|TWO_SIDED|95.0|3.19|9.76||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||9.76|3.19|<0.0001
70973943|NCT00848354|141455006|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.49|||<|0.0001|TWO_SIDED|95.0|3.16|9.52||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||9.52|3.16|<0.0001
70973944|NCT00848354|141455006|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.59|||<|0.0001|TWO_SIDED|95.0|3.87|11.21||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||11.21|3.87|<0.0001
70973945|NCT00848354|141455008|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.52|||<|0.0001|TWO_SIDED|95.0|2.3|5.4||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||5.40|2.30|<0.0001
70973946|NCT00848354|141455008|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.87|||<|0.0001|TWO_SIDED|95.0|3.07|7.71||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||7.71|3.07|<0.0001
70973947|NCT00848354|141455008|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0|||<|0.0001|TWO_SIDED|95.0|2.98|8.41||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||8.41|2.98|<0.0001
70973948|NCT00848354|141455008|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.0001|TWO_SIDED|95.0|2.55|7.58||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||7.58|2.55|<0.0001
70921089|NCT00567489|141333329|SUPERIORITY||Mean Difference (Final Values)|0.4|||<|0.001|TWO_SIDED|95.0|0.2|0.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 3||0.6|0.2|<0.001
70921090|NCT00567489|141333329|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.003|TWO_SIDED|95.0|0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 6||0.5|0.1|0.003
70921091|NCT00567489|141333329|SUPERIORITY||Mean Difference (Final Values)|0.8|||<|0.001|TWO_SIDED|95.0|0.4|1.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 3||1.3|0.4|<0.001
70921092|NCT00567489|141333329|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.002|TWO_SIDED|95.0|0.3|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 6||1.1|0.3|0.002
70921093|NCT00567489|141333330|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.485|TWO_SIDED|95.0|-8.6|4.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 3||4.1|-8.6|0.485
70921094|NCT00567489|141333330|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.556|TWO_SIDED|95.0|-8.2|4.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 6||4.4|-8.2|0.556
70921095|NCT00567489|141333330|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.101|TWO_SIDED|95.0|-1.1|12.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 3||12.2|-1.1|0.101
70921096|NCT00567489|141333330|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.134|TWO_SIDED|95.0|-1.5|11.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 6||11.5|-1.5|0.134
70921097|NCT00567489|141333330|SUPERIORITY||Mean Difference (Final Values)|11.4||||0.004|TWO_SIDED|95.0|3.6|19.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 3||19.2|3.6|0.004
70921098|NCT00567489|141333330|SUPERIORITY||Mean Difference (Final Values)|8.4||||0.03|TWO_SIDED|95.0|0.8|15.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 6||15.9|0.8|0.030
70921099|NCT00567489|141333331|SUPERIORITY||Mean Difference (Final Values)|-56.5||||0.655|TWO_SIDED|95.0|-304.6|191.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 3||191.7|-304.6|0.655
70921100|NCT00567489|141333331|SUPERIORITY||Mean Difference (Final Values)|-29.2||||0.811|TWO_SIDED|95.0|-268.9|210.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 6||210.5|-268.9|0.811
70921101|NCT00567489|141333331|SUPERIORITY||Mean Difference (Final Values)|441.3||||0.419|TWO_SIDED|95.0|-630.4|1513.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 3||1513.1|-630.4|0.419
70921102|NCT00567489|141333331|SUPERIORITY||Mean Difference (Final Values)|121.8||||0.82|TWO_SIDED|95.0|-927.9|1171.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 6||1171.5|-927.9|0.820
70921103|NCT00567489|141333332|SUPERIORITY||Mean Difference (Final Values)|-4.2||||0.721|TWO_SIDED|95.0|-27.5|19.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 3||19|-27.5|0.721
70921104|NCT00567489|141333332|SUPERIORITY||Mean Difference (Final Values)|13.5||||0.247|TWO_SIDED|95.0|-9.4|36.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 6||36.4|-9.4|0.247
70921105|NCT00567489|141333333|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.624|TWO_SIDED|95.0|0.55|1.43|||ANOVA|||Estimates of Ratio-Month 6||1.43|0.55|0.624
70921106|NCT00567489|141333334|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.338|TWO_SIDED|95.0|-0.6|1.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 3||1.8|-0.6|0.338
70921107|NCT00567489|141333334|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.029|TWO_SIDED|95.0|0.1|2.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 6||2.5|0.1|0.029
70921108|NCT00567489|141333334|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.817|TWO_SIDED|95.0|-1.9|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 3||1.5|-1.9|0.817
70921109|NCT00567489|141333334|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.091|TWO_SIDED|95.0|-0.2|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 6||2.9|-0.2|0.091
70921110|NCT00567489|141333335|SUPERIORITY||Mean Difference (Final Values)|-10.2||||0.127|TWO_SIDED|95.0|-23.3|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 3||2.9|-23.3|0.127
70921111|NCT00567489|141333335|SUPERIORITY||Mean Difference (Final Values)|-10.3|||<|0.001|TWO_SIDED|95.0|-16.4|-4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 6||-4.3|-16.4|<0.001
70921112|NCT00567489|141333335|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.012|TWO_SIDED|95.0|-0.4|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 3||-0.1|-0.4|0.012
70921113|NCT00567489|141333335|SUPERIORITY||Mean Difference (Final Values)|-0.2|||<|0.001|TWO_SIDED|95.0|-0.3|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 6||-0.1|-0.3|<0.001
70921114|NCT00567489|141333336|SUPERIORITY||Mean Difference (Final Values)|3.2||||0.019|TWO_SIDED|95.0|0.5|5.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 3||5.8|0.5|0.019
70921115|NCT00567489|141333336|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.019|TWO_SIDED|95.0|0.5|5.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 6||5.6|0.5|0.019
70921116|NCT00567489|141333337|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.884|TWO_SIDED|95.0|-3.9|3.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 3||3.4|-3.9|0.884
70921117|NCT00567489|141333337|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.716|TWO_SIDED|95.0|-3.0|4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 6||4.3|-3|0.716
70921118|NCT00567489|141333338|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.961|TWO_SIDED|95.0|-1.2|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 3||1.1|-1.2|0.961
70921119|NCT00567489|141333338|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.581|TWO_SIDED|95.0|-0.8|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 6||1.5|-0.8|0.581
71032967|NCT01299454|141575376|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.103|||||TWO_SIDED|90.0|0.774|1.573|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.573|0.774|
71032968|NCT01299454|141575376|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.199|||||TWO_SIDED|90.0|0.841|1.71|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.710|0.841|
71032969|NCT01299454|141575376|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.79|||||TWO_SIDED|90.0|0.524|1.189|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.189|0.524|
71032970|NCT01299454|141575377|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.241|||||TWO_SIDED|90.0|0.719|2.143|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||2.143|0.719|
71032971|NCT01299454|141575377|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance|Geometric Mean Ratio|1.604|||||TWO_SIDED|90.0|0.942|2.732|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||2.732|0.942|
71032972|NCT01299454|141575377|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.077|||||TWO_SIDED|90.0|0.54|2.146|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||2.146|0.540|
71095068|NCT02827708|141698395|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-1.0|||<|0.0001||95.0|-1.2|-0.8||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral semaglutide 14 mg - Placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata, interaction strata and region as categorical fixed effects and the baseline value as covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.8|-1.2|<0.0001
70921120|NCT00567489|141333339|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.871|TWO_SIDED|95.0|-3.7|3.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Waist Circumference-Month 6||3.1|-3.7|0.871
70921121|NCT00567489|141333340|SUPERIORITY||Mean Difference (Final Values)|5.2||||0.608|TWO_SIDED|95.0|-14.7|25.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 3||25|-14.7|0.608
70921122|NCT00567489|141333340|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.731|TWO_SIDED|95.0|-11.5|8.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 6||8.1|-11.5|0.731
70921123|NCT00567489|141333340|SUPERIORITY||Mean Difference (Final Values)|185.3||||0.377|TWO_SIDED|95.0|-227.5|598.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 3||598.1|-227.5|0.377
70921124|NCT00567489|141333340|SUPERIORITY||Mean Difference (Final Values)|-18.3||||0.854|TWO_SIDED|95.0|-214.4|177.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 6||177.8|-214.4|0.854
70921125|NCT00567489|141333341|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.412|TWO_SIDED|95.0|-0.03|0.07|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 3||0.07|-0.03|0.412
70921126|NCT00567489|141333341|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.485|TWO_SIDED|95.0|-0.07|0.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 6||0.03|-0.07|0.485
70921127|NCT00567489|141333342|SUPERIORITY||Mean Difference (Final Values)|2.18||||0.525|TWO_SIDED|95.0|-4.56|8.93|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 3||8.93|-4.56|0.525
70973949|NCT00848354|141455008|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.81|||<|0.0001|TWO_SIDED|95.0|3.15|10.74||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||10.74|3.15|<0.0001
70973950|NCT00848354|141455008|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.18|||<|0.0001|TWO_SIDED|95.0|3.25|11.73||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||11.73|3.25|<0.0001
70973951|NCT00848354|141455008|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.45|||<|0.0001|TWO_SIDED|95.0|3.67|11.33||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||11.33|3.67|<0.0001
70973952|NCT00848354|141455010|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.09||||0.0349|TWO_SIDED|95.0|1.05|9.13||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||9.13|1.05|0.0349
70973953|NCT00848354|141455010|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.87|||<|0.0001|TWO_SIDED|95.0|1.98|7.6||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||7.60|1.98|<0.0001
70973954|NCT00848354|141455010|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.52|||<|0.0001|TWO_SIDED|95.0|2.1|5.88||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||5.88|2.10|<0.0001
70973955|NCT00848354|141455010|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.2|||<|0.0001|TWO_SIDED|95.0|2.02|5.06||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||5.06|2.02|<0.0001
70973956|NCT00848354|141455010|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.0001|TWO_SIDED|95.0|2.78|6.96||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||6.96|2.78|<0.0001
70973957|NCT00848354|141455010|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.0001|TWO_SIDED|95.0|2.8|6.9||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||6.90|2.80|<0.0001
70973958|NCT00848354|141455010|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.13|||<|0.0001|TWO_SIDED|95.0|3.82|9.85||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||9.85|3.82|<0.0001
70973959|NCT00848354|141455012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.25|||<|0.0001|TWO_SIDED|95.0|2.74|6.6||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||6.60|2.74|<0.0001
70973960|NCT00848354|141455012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.6|||<|0.0001|TWO_SIDED|95.0|2.94|7.18||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||7.18|2.94|<0.0001
70973961|NCT00848354|141455012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.21|||<|0.0001|TWO_SIDED|95.0|3.15|8.61||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||8.61|3.15|<0.0001
70973962|NCT00848354|141455012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.77|||<|0.0001|TWO_SIDED|95.0|3.36|9.93||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||9.93|3.36|<0.0001
70973963|NCT00848354|141455012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.15|||<|0.0001|TWO_SIDED|95.0|3.91|13.09||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||13.09|3.91|<0.0001
70973964|NCT00848354|141455012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.43|||<|0.0001|TWO_SIDED|95.0|4.5|15.8||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||15.80|4.50|<0.0001
71032973|NCT01299454|141575378|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric mean ratio|0.856|||||TWO_SIDED|90.0|0.691|1.059|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.059|0.691|
71032974|NCT01299454|141575378|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.742|||||TWO_SIDED|90.0|0.599|0.918|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.918|0.599|
71032975|NCT01299454|141575378|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.451|||||TWO_SIDED|90.0|0.352|0.577|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.577|0.352|
71032976|NCT01299454|141575387|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.509|||||TWO_SIDED|90.0|0.346|0.748|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.748|0.346|
71032977|NCT01299454|141575387|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.586|||||TWO_SIDED|90.0|0.399|0.861|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.861|0.399|
71095069|NCT02827708|141698396|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.8||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-1.8|-3.2|<0.0001
70921128|NCT00567489|141333342|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.995|TWO_SIDED|95.0|-6.79|6.83|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 6||6.83|-6.79|0.995
70921129|NCT00567489|141333343|SUPERIORITY||Mean Difference (Final Values)|-1.87||||0.526|TWO_SIDED|95.0|-7.64|3.91|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 3||3.91|-7.64|0.526
70921130|NCT00567489|141333343|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.779|TWO_SIDED|95.0|-5.01|6.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 6||6.68|-5.01|0.779
70921131|NCT00567489|141333343|SUPERIORITY||Mean Difference (Final Values)|-2.95||||0.246|TWO_SIDED|95.0|-7.95|2.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 3||2.04|-7.95|0.246
70921132|NCT00567489|141333343|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.78|TWO_SIDED|95.0|-5.78|4.34|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 6||4.34|-5.78|0.780
70921133|NCT00567489|141333343|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.885|TWO_SIDED|95.0|-5.22|6.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 3||6.04|-5.22|0.885
70921134|NCT00567489|141333343|SUPERIORITY||Mean Difference (Final Values)|4.41||||0.128|TWO_SIDED|95.0|-1.28|10.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 6||10.10|-1.28|0.128
71095070|NCT02827708|141698396|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-2.7|||<|0.0001|TWO_SIDED|95.0|-3.5|-1.9||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral semaglutide 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata, interaction strata and region as categorical fixed effects and the baseline value as covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.9|-3.5|<0.0001
71095071|NCT02827708|141698412|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.64|||=|0.1834|TWO_SIDED|95.0|0.34|1.23||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.23|0.34|=0.1834
71095072|NCT02827708|141698413|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.43|||=|0.061|TWO_SIDED|95.0|0.17|1.04||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||1.04|0.17|=0.0610
71095073|NCT01137812|141698435|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation: assuming a difference between canagliflozin and sitagliptin of 0.0% and a common standard deviation of 1.0%, and using a 2-sample, 1-sided t-test with a Type I error rate of 0.025, it was estimated that 234 patients per group would provide approximately 90% power to demonstrate non-inferiority with the non-inferiority margin of 0.3, comparing canagliflozin with sitagliptin.|Least-Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.064|<|0.05|TWO_SIDED|95.0|-0.5|-0.25|||ANCOVA|||If the hypothesis of non-inferiority of canagliflozin to sitagliptin at Week 52 was demonstrated (ie, upper bound of the 95% Confidence Interval of the treatment difference \[canagliflozin minus sitagliptin\] was less than 0.3) and the upper bound was less than 0.0, the superiority of the canagliflozin dose relative to sitagliptin would be concluded.||-0.250|-0.500|<0.05
71095074|NCT01137812|141698436|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|1.3|2.48|||Regression, Logistic|||||2.48|1.30|
71095075|NCT01137812|141698437|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-24.1|||<|0.001|TWO_SIDED|95.0|-29.89|-18.24|||ANCOVA|||||-18.24|-29.89|<0.001
71095076|NCT01137812|141698438|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.3|-2.2|||ANCOVA|||||-2.2|-3.3|<0.001
71095077|NCT01137812|141698439|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-5.91|STANDARD_ERROR_OF_MEAN|0.883|<|0.001|TWO_SIDED|95.0|-7.642|-4.175|||ANCOVA|||||-4.175|-7.642|<0.001
71095078|NCT01137812|141698440|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|3.9||0.554|TWO_SIDED|95.0|-9.8|5.3|||ANCOVA|||||5.3|-9.8|0.554
71095079|NCT01137812|141698441|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|4.6|9.3|||ANCOVA|||||9.3|4.6|<0.001
71095080|NCT04621760|141698444|SUPERIORITY|||||||0.51||||||a priori threshold for statistical significance: 0.05|Fisher Exact|||||||0.51
71154157|NCT03799341|141800936|OTHER|||||||0.024|||||||ANOVA|||Due to violations of normality assumptions, a non-parametric Aligned Rank Transform ANOVA was conducted, which does not permit covariates. A median split approach was therefore used to examine the influence of self-reported cocaine abstinence during treatment. The design included 4 factors: time (2 levels), response accuracy (2 levels), electrode pair (4 levels), and median split group membership (2 levels). Reported results reflect the interaction between time and median split group.||||0.024
71154158|NCT03799341|141800937|OTHER|||||||0.973|||||||ANOVA|||No violations of normality assumptions were identified. A repeated measures ANOVA was conducted. To maintain consistency with other outcome measures, a median split approach was used to examine the potential influence of Contingency Management session attendance. The design included two factors: time (2 levels) and median split group membership (2 levels). Reported results reflect the interaction between time and median split group.||||0.973
71154159|NCT03799341|141800937|OTHER|||||||0.662|||||||ANOVA|||No violations of normality assumptions were identified. A repeated measures ANOVA was conducted. To maintain consistency with other outcome measures, a median split approach was used to examine the potential influence of self-reported cocaine abstinence during the 12-week treatment interval. The design included two factors: time (2 levels) and median split group membership (2 levels). Reported results reflect the interaction between time and median split group.||||0.662
71154160|NCT03799341|141800938|OTHER|||||||0.878|||||||ANOVA|||Due to violations of normality assumptions, a non-parametric Aligned Rank Transform ANOVA was conducted, which does not permit inclusion of covariates. A median split approach was therefore used to examine the potential influence of Contingency Management session attendance. The design included 3 factors: time (2 levels), condition (2 levels), and median split group membership (2 levels). Reported results reflect the interaction between time, condition, and median split group.||||0.878
70921135|NCT00567489|141333343|SUPERIORITY||Mean Difference (Final Values)|1.07||||0.701|TWO_SIDED|95.0|-4.4|6.54|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 3||6.54|-4.40|0.701
71095081|NCT04621760|141698445|SUPERIORITY|||||||0.62||||||threshold for significance: 0.05|Fisher Exact|one sided Fisher's exct test, given small cell sizes.||||||0.62
71095082|NCT04621760|141698446|SUPERIORITY|||||||0.207||||||a priori threshold for significance: 0.05|Fisher Exact|Fisher's exact test used due to small sample size||||||0.207
71095083|NCT04621760|141698447|SUPERIORITY|||||||0.496||||||a priori threshold for significance: 0.05|Fisher Exact|Fisher's exact test used due to small cell size||||||0.496
71095084|NCT04621760|141698448|SUPERIORITY|||||||0.02||||||a priori threshold for significance: 0.05|Chi-squared|||"Test comparing proportion correctly identifying PrEP is a daily pill to prevent HIV"||||0.02
70921136|NCT00567489|141333343|SUPERIORITY||Mean Difference (Final Values)|7.21||||0.01|TWO_SIDED|95.0|1.7|12.73|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 6||12.73|1.70|0.010
70921137|NCT00567489|141333343|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.934|TWO_SIDED|95.0|-4.63|5.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 3||5.03|-4.63|0.934
70921138|NCT00567489|141333343|SUPERIORITY||Mean Difference (Final Values)|3.13||||0.209|TWO_SIDED|95.0|-1.75|8.01|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 6||8.01|-1.75|0.209
70921139|NCT00567489|141333343|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.585|TWO_SIDED|95.0|-4.9|8.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 3||8.68|-4.90|0.585
70921140|NCT00567489|141333343|SUPERIORITY||Mean Difference (Final Values)|1.62||||0.641|TWO_SIDED|95.0|-5.22|8.47|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 6||8.47|-5.22|0.641
70921141|NCT00567489|141333343|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.586|TWO_SIDED|95.0|-6.89|3.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 3||3.90|-6.89|0.586
70973965|NCT00848354|141455012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.05|||<|0.0001|TWO_SIDED|95.0|3.5|10.47||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||10.47|3.50|<0.0001
70973966|NCT00848354|141455014|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.4||||0.025|TWO_SIDED|95.0|0.96|56.88||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||56.88|0.96|0.0250
70973967|NCT00848354|141455014|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.33||||0.0466|TWO_SIDED|95.0|1.0|5.45||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||5.45|1.00|0.0466
70973968|NCT00848354|141455014|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.84||||0.0007|TWO_SIDED|95.0|1.5|5.36||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||5.36|1.50|0.0007
70973969|NCT00848354|141455014|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.97|||<|0.0001|TWO_SIDED|95.0|1.7|5.18||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||5.18|1.70|<0.0001
70973970|NCT00848354|141455014|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.06|||<|0.0001|TWO_SIDED|95.0|1.85|5.05||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||5.05|1.85|<0.0001
70973971|NCT00848354|141455014|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.12|||<|0.0001|TWO_SIDED|95.0|2.47|6.87||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||6.87|2.47|<0.0001
71095085|NCT04621760|141698448|SUPERIORITY|||||||0.01||||||a priori threshold for significance: 0.05|Chi-squared|||"Test comparing proportion correctly responding to prompt: PrEP is for all adults"||||0.01
70921142|NCT00567489|141333343|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.906|TWO_SIDED|95.0|-5.79|5.14|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 6||5.14|-5.79|0.906
70921143|NCT00567489|141333343|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.97|TWO_SIDED|95.0|-4.93|4.75|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 3||4.75|-4.93|0.970
70921144|NCT00567489|141333343|SUPERIORITY||Mean Difference (Final Values)|2.38||||0.34|TWO_SIDED|95.0|-2.52|7.28|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 6||7.28|-2.52|0.340
70921145|NCT00567489|141333344|SUPERIORITY||Mean Difference (Final Values)|24.6||||0.495|TWO_SIDED|95.0|-46.9|96.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Subcutaneous Fat Volume-Month 6||96|-46.9|0.495
70921146|NCT00567489|141333344|SUPERIORITY||Mean Difference (Final Values)|55.4||||0.081|TWO_SIDED|95.0|-7.0|117.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Visceral Fat Volume-Month 6||117.8|-7|0.081
70973972|NCT00848354|141455014|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.51|||<|0.0001|TWO_SIDED|95.0|3.72|11.38||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||11.38|3.72|<0.0001
70973973|NCT00848354|141455016|SUPERIORITY_OR_OTHER|||||||0.3054||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||||0.3054
70973974|NCT00848354|141455016|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.09||||0.4044|TWO_SIDED|95.0|0.58|7.53||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||7.53|0.58|0.4044
70973975|NCT00848354|141455016|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.53||||0.0388|TWO_SIDED|95.0|1.02|6.26||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||6.26|1.02|0.0388
70973976|NCT00848354|141455016|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.89||||0.0059|TWO_SIDED|95.0|1.31|6.34||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||6.34|1.31|0.0059
71095086|NCT04621760|141698448|SUPERIORITY||||||<|0.01||||||a priori threshold for significance: 0.05|Chi-squared|||"Test comparing proportion who correctly identified: PrEP will not work if taken once a week"||||<0.01
71032978|NCT01299454|141575387|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.334|||||TWO_SIDED|90.0|0.214|0.521|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.521|0.214|
71032979|NCT01299454|141575388|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.716|||||TWO_SIDED|90.0|0.445|1.153|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.153|0.445|
71032980|NCT01299454|141575388|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.594|||||TWO_SIDED|90.0|0.378|0.934|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.934|0.378|
71032981|NCT01299454|141575388|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.561|||||TWO_SIDED|90.0|0.308|1.022|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.022|0.308|
71032982|NCT01299454|141575389|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.558|||||TWO_SIDED|90.0|0.368|0.845|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.845|0.368|
71032983|NCT01299454|141575389|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.516|||||TWO_SIDED|90.0|0.341|0.781|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.781|0.341|
71095087|NCT04621760|141698448|SUPERIORITY||||||<|0.01||||||a priori threshold for significance: 0.05|Chi-squared|||"Test of proportion who correctly identified PrEP does not prevent STDs other than HIV"||||<0.01
71095088|NCT04621760|141698448|SUPERIORITY||||||<|0.01||||||a priori threshold for significance: 0.05|Chi-squared|||"Test comparing proportion who correctly identified, PrEP side effects do not last forever"||||<0.01
71095089|NCT04621760|141698448|SUPERIORITY|||||||0.03||||||a priori threshold for significance: 0.05|Chi-squared|||"Test comparing proportion who correctly identified, A baby could be norm to HIV discordant parents without transmitting HIV"||||0.03
70921147|NCT00567489|141333345|SUPERIORITY||Mean Difference (Final Values)|6.3||||0.626|TWO_SIDED|95.0|-19.3|31.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Diastolic Volume-Month 6||31.9|-19.3|0.626
70921148|NCT00567489|141333345|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.486|TWO_SIDED|95.0|-14.5|30.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Systolic Volume-Month 6||30.1|-14.5|0.486
70921149|NCT00567489|141333346|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.832|TWO_SIDED|95.0|-18.9|23.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass with Pap Muscles-Month 6||23.4|-18.9|0.832
70921150|NCT00567489|141333346|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.82|TWO_SIDED|95.0|-18.3|23.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass without Pap Muscles-Month 6||23.1|-18.3|0.820
70921151|NCT00567489|141333347|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.955|TWO_SIDED|95.0|-6.9|6.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Ejection Fraction-Month 6||6.5|-6.9|0.955
70921152|NCT02570022|141333348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||t-test, 2 sided||This analysis corresponds to the visual analog scale and morphine equivalent data.|Our hypothesis was that in patients undergoing shoulder arthroplasty, treatment with LB would lead to no significant differences in average daily pain scores. A power analysis was performed prior to the study to assess the primary hypothesis that a significant difference in average daily pain of 13mm on VAS will not be found between the INB and LB groups. With a power of 80% (beta level = 0.80, alpha level = 0.05), a sample size of 25 patients per group was obtained||||<0.05
71095090|NCT04621760|141698448|SUPERIORITY||||||<|0.01||||||a priori threshold for significance: 0.05|Chi-squared|||"Test comparing proportion who correctly identified There is medication you can take after sex to prevent HIV"||||<0.01
71095091|NCT04621760|141698448|SUPERIORITY|||||||0.29||||||a priori threshold for significance: 0.05|Chi-squared|||"Test for proportion who correctly identified PrEP efficacy is \> 95%"||||0.29
70921153|NCT00041938|141333350|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.4|TWO_SIDED|95.0|0.79|1.1||The primary null hypotheses was tested at two-tailed alpha=0.05. A Haybittle-Peto interim monitoring procedure was performed with stopping boundaries for the interim analyses corresponding to a nominal two-tailed P value of 0.001.|Regression, Cox|Cox models stratified by site, New York Heart Association class (I vs. II-IV), and status w/ respect to recent stroke or Transient Ischemic Attack.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|The primary null hypothesis: time to first event in the composite primary endpoint does not differ significantly between warfarin and aspirin. The original target sample size was 2860, providing 89% power for a log-rank test with two-sided alpha .05, assuming a hazard rate reduction of 17.82% in either group compared with the other, after adjustment for use of beta-blockers and allowance for discontinuation of therapy, dropout, and crossover. The final sample of 2305 patients yielded 69% power.||1.10|0.79|0.40
70921154|NCT00041938|141333351|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.33|TWO_SIDED|95.0|0.93|1.23||Secondary null hypothesis was tested at two-tailed alpha = 0.05.|Regression, Cox|Cox models stratified by site, New York Heart Association class (I vs. II-IV), and status w/ respect to recent stroke or Transient Ischemic Attack.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|Secondary null hypothesis: time to first event in the composite secondary endpoint does not differ significantly between warfarin and aspirin. This was tested at prespecified alpha = 0.05 level, two-tailed.||1.23|0.93|0.33
70921155|NCT00041938|141333352|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.52||||0.005|TWO_SIDED|95.0|0.33|0.82|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|Null hypothesis: there is no difference between warfarin and aspirin in time to ischemic stroke, adjusting for competing risks of death and intracerebral hemorrhage.||0.82|0.33|0.005
70921156|NCT00041938|141333353|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.22||||0.35||95.0|0.43|11.66|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.||Null hypothesis: there is no difference between warfarin and aspirin in time to intracerebral hemorrhage, adjusting for competing risks of death and ischemic stroke.||11.66|0.43|0.35
70921157|NCT00041938|141333354|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.91|TWO_SIDED|95.0|0.85|1.2|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|||1.20|0.85|0.91
70921158|NCT00041938|141333355|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.93|TWO_SIDED|95.0|0.58|1.64|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|Null hypothesis: there is no difference between warfarin and aspirin in time to myocardial infarction, adjusting for competing risks of heart failure hospitalization, ischemic stroke, intracerebral hemorrhage, and death.||1.64|0.58|0.93
70921159|NCT00041938|141333356|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||0.053|TWO_SIDED|95.0|0.998|1.47|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.||Null hypothesis: there is no difference between warfarin and aspirin in time to heart failure hospitalization, adjusting for competing risks of myocardial infarction, ischemic stroke, intracerebral hemorrhage, and death.||1.47|0.998|0.053
70921160|NCT00041938|141333357|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55||||0.03|TWO_SIDED|95.0|0.32|0.96|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.||Null hypothesis: there is no difference between warfarin and aspirin in time to ischemic stroke, adjusting for competing risks of myocardial infarction, heart failure hospitalization, death and intracerebral hemorrhage.||0.96|0.32|0.03
70921161|NCT00041938|141333358|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.77||||0.51|TWO_SIDED|95.0|0.32|9.88|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|Null hypothesis: there is no difference between warfarin and aspirin in time to intracerebral hemorrhage, adjusting for competing risks of myocardial infarction, heart failure hospitalization, ischemic stroke, and death.||9.88|0.32|0.51
70921162|NCT00041938|141333359|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.83||95.0|0.81|1.3|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.||||1.30|0.81|0.83
70921163|NCT00041938|141333360|SUPERIORITY_OR_OTHER||Rate ratio|2.05|||<|0.001|TWO_SIDED|95.0|1.36|3.12|||Regression, Poisson||The warfarin arm represents the numerator and the aspirin arm represents the denominator of the rate ratio.|||3.12|1.36|<0.001
70921164|NCT00041938|141333361|SUPERIORITY_OR_OTHER||Rate ratio|1.56|||<|0.001||95.0|1.34|1.81|||Regression, Poisson||Warfarin group represents the numerator and aspirin group represents denominator of rate ratio.|||1.81|1.34|<0.001
70921165|NCT04515641|141333384|OTHER||GMR|0.75|||||TWO_SIDED|90.0|0.58|0.96|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|0.96|0.58|
70921166|NCT04515641|141333385|OTHER||GMR|0.75|||||TWO_SIDED|90.0|0.58|0.98|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|0.98|0.58|
70973977|NCT00848354|141455016|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.3|||<|0.0001|TWO_SIDED|95.0|1.99|9.29||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||9.29|1.99|<0.0001
70973978|NCT00848354|141455016|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.94|||<|0.0001|TWO_SIDED|95.0|2.88|12.24||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||12.24|2.88|<0.0001
70973979|NCT00848354|141455016|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.18|||<|0.0001|TWO_SIDED|95.0|3.61|23.32||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||23.32|3.61|<0.0001
70973980|NCT00848354|141455018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.4||||0.025|TWO_SIDED|95.0|0.96|56.88||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||56.88|0.96|0.0250
70973981|NCT00848354|141455018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.33||||0.0466|TWO_SIDED|95.0|1.0|5.45||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||5.45|1.00|0.0466
70973982|NCT00848354|141455018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.84||||0.0007|TWO_SIDED|95.0|1.5|5.36||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||5.36|1.50|0.0007
70973983|NCT00848354|141455018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.97|||<|0.0001|TWO_SIDED|95.0|1.7|5.18||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||5.18|1.70|<0.0001
70973984|NCT00848354|141455018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.06|||<|0.0001|TWO_SIDED|95.0|1.85|5.05||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||5.05|1.85|<0.0001
70973985|NCT00848354|141455018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.12|||<|0.0001|TWO_SIDED|95.0|2.47|6.87||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||6.87|2.47|<0.0001
70973986|NCT00848354|141455018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.51|||<|0.0001|TWO_SIDED|95.0|3.72|11.38||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||11.38|3.72|<0.0001
70973987|NCT00848354|141455020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.53|||<|0.0001|TWO_SIDED|95.0|2.9|7.07||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||7.07|2.90|<0.0001
70973988|NCT00848354|141455020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.01|||<|0.0001|TWO_SIDED|95.0|2.36|6.8||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||6.80|2.36|<0.0001
70973989|NCT00848354|141455020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.23|||<|0.0001|TWO_SIDED|95.0|2.82|9.72||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||9.72|2.82|<0.0001
70973990|NCT00848354|141455020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.25|||<|0.0001|TWO_SIDED|95.0|2.63|10.47||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||10.47|2.63|<0.0001
70973991|NCT00848354|141455020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.53|||<|0.0001|TWO_SIDED|95.0|3.16|13.48||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||13.48|3.16|<0.0001
71095092|NCT04621760|141698449|SUPERIORITY|||||||0.04||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.||||0.04
70973992|NCT00848354|141455020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.38|||<|0.0001|TWO_SIDED|95.0|3.86|18.17||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||18.17|3.86|<0.0001
70973993|NCT00848354|141455020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.84|||<|0.0001|TWO_SIDED|95.0|3.94|15.62||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||15.62|3.94|<0.0001
70973994|NCT00848354|141455022|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.67|||<|0.0001|TWO_SIDED|95.0|2.35|5.73||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||5.73|2.35|<0.0001
70973995|NCT00848354|141455022|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.65|||<|0.0001|TWO_SIDED|95.0|3.0|7.22||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||7.22|3.00|<0.0001
71095093|NCT04621760|141698450|SUPERIORITY|||||||0.02||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.||||0.02
70973996|NCT00848354|141455022|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.96|||<|0.0001|TWO_SIDED|95.0|3.05|8.06||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||8.06|3.05|<0.0001
70973997|NCT00848354|141455022|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.34|||<|0.0001|TWO_SIDED|95.0|3.18|8.96||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||8.96|3.18|<0.0001
70973998|NCT00848354|141455022|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.7|||<|0.0001|TWO_SIDED|95.0|3.23|10.06||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||10.06|3.23|<0.0001
70973999|NCT00848354|141455022|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.88|||<|0.0001|TWO_SIDED|95.0|4.37|14.2||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||14.20|4.37|<0.0001
70974000|NCT00848354|141455022|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.73|||<|0.0001|TWO_SIDED|95.0|3.4|9.65||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||9.65|3.40|<0.0001
70974001|NCT00848354|141455024|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
71095094|NCT04621760|141698451|SUPERIORITY|||||||0.05||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.||||0.05
71154161|NCT03799341|141800938|OTHER|||||||0.645|||||||ANOVA|||Due to violations of normality assumptions, a non-parametric Aligned Rank Transform ANOVA was conducted, which does not permit inclusion of covariates. A median split approach was therefore used to examine the potential influence of self-reported cocaine abstinence during treatment. The design included 3 factors: time (2 levels), condition (2 levels), and median split group membership (2 levels). Reported results reflect the interaction between time, condition, and median split group.||||0.645
71154162|NCT01116648|141800953|OTHER||Maximum Tolerated Dose (mg)|30.0|||||TWO_SIDED||||||||Cediranib|||||
70974002|NCT00848354|141455026|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
70974003|NCT00848354|141455028|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
70974004|NCT00848354|141455030|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
70974005|NCT00848354|141455032|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 2.||||<0.0001
70974006|NCT00848354|141455032|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 4.||||0.0007
70974007|NCT00848354|141455032|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0009
70974008|NCT00848354|141455032|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 12.||||0.0007
70974009|NCT00848354|141455032|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0005
71154163|NCT01116648|141800953|OTHER||Maximum Tolerated Dose (mg BID)|200.0|||||TWO_SIDED||||||||Olaparib|||||
71154164|NCT01116648|141800955|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.006|TWO_SIDED|95.0|0.3|0.83|||Kaplan-Meier Plot|||||0.83|0.30|0.006
71032984|NCT01299454|141575389|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.314|||||TWO_SIDED|90.0|0.195|0.507|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.507|0.195|
71032985|NCT03965091|141575401|OTHER||Least square (LS) mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.27||0.7963|TWO_SIDED|95.0|-0.46|0.6|||Mixed Models Analysis|||Analysis was performed using a Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the daily average PI-NRS score over the past 24 hours at weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 as the dependent variable, sex, age group at FM onset, week, treatment, and treatment-by-week interaction as fixed factors, and baseline average of the daily average PI-NRS score as a covariate.||0.60|-0.46|0.7963
70974010|NCT00848354|141455032|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 20.||||<0.0001
70974011|NCT00848354|141455032|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
70974012|NCT00848354|141455034|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
70974013|NCT00848354|141455036|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
70974014|NCT00848354|141455038|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
70974015|NCT00848354|141455040|SUPERIORITY_OR_OTHER|||||||0.1975|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value.||||0.1975
71032986|NCT03965091|141575401|OTHER||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.27||0.8629|TWO_SIDED|95.0|-0.48|0.58|||Mixed Models Analysis|||Analysis was performed using an MMRM model with change from baseline in the weekly average of the daily average PI-NRS score over the past 24 hours at weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 as the dependent variable, sex, age group at FM onset, week, treatment, and treatment-by-week interaction as fixed factors, and baseline average of the daily average PI-NRS score as a covariate.||0.58|-0.48|0.8629
71032987|NCT00982397|141575421|SUPERIORITY_OR_OTHER||percentage of participants|98.5|||||TWO_SIDED|95.0|97.9|99.0|||||Therapy rates were analyzed using competing risks survival analysis methods, accounting for death as a competing risk.Therapy incidence rates were estimated using cumulative incidence functions and reported with 95% confidence interval.|The study was designed to include at least 1,131 patients with DR/CRT-D ICD devices in order to estimate the inappropriate shock free rate at 1 year post-implant with 1% precision.||99.0|97.9|
71095095|NCT04621760|141698452|SUPERIORITY|||||||0.03||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.||||0.03
70974016|NCT00848354|141455041|SUPERIORITY_OR_OTHER|||||||0.0044|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value.||||0.0044
70974017|NCT00848354|141455042|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
70974018|NCT00848354|141455044|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 2.||||<0.0001
71095096|NCT04621760|141698453|SUPERIORITY|||||||0.07||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.||||0.07
70921167|NCT04515641|141333386|OTHER||GMR|0.65|||||TWO_SIDED|90.0|0.38|1.14|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.14|0.38|
71032988|NCT00982397|141575421|SUPERIORITY_OR_OTHER||percentage of participants|97.5|||||TWO_SIDED|95.0|96.1|98.5|||||Therapy rates were analyzed using competing risks survival analysis methods, accounting for death as a competing risk.Therapy incidence rates were estimated using cumulative incidence functions and reported with 95% confidence interval.|This study was designed to include at least 610 patients with VR-ICD devices in order to estimate the inappropriate shock free rate at 1 year post-implant with a precision of 2%.||98.5|96.1|
71032989|NCT00982397|141575422|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value is for comparison against a performance criterion of 10%.|Exact Binomial|||Using the one-sided one proportion Exact Test in PASS sample size software, a sample size of 76 subjects with 1-month follow-up was calculated to be required for the evaluation of this objective. To ensure adequate testing of the Protecta XT CRT-D device, the 76 subjects must have included at least 34 CRT-D subjects. Assuming an attrition rate of 10%, a sample size of 85 subjects enrolled was calculated to be required.||||<0.0001
71032990|NCT00982397|141575423|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value is for comparison of the observed proportion of successes against a protocol-specified performance criterion of 95%.|Confidence interval and hypothesis test|||P, the expected proportion of successes under the null hypothesis, was 95%. α, the Type I error rate, is 0.025. Power is 90%. Pa, the assumed true proportion of successes, is 99%. Based on the above assumptions, at least 173 subjects with a useable time to VF detection testing were required for this objective. Assuming a 5% rate for the potential non-adherence to the testing protocol, the required enrollment sample size was 183.||||<0.0001
71032991|NCT00982397|141575424|NON_INFERIORITY_OR_EQUIVALENCE|Ho: p1 ≤ p2 - 0.05 Ha: p1 \> p2 - 0.05 Where p1 was the syncopal event free rate at one year post implant by programming VF NID 30/40 and p2 for NID = 18/24. If the null-hypothesis was rejected it was concluded that NID = 30/40 did not decrease the syncope free rate by more than 5% compared to NID = 18/24 and hence was non-inferior.|Risk Difference (RD)|0.0||||0.0013|TWO_SIDED|90.0|-2.7|2.7||P-Value is for non-inferiority|Farrington-Manning||The 90% Confidence Interval is for the difference (p1-p2), where p1=syncope free rate 30/40 arm and p2=syncope free rate 18/24 arm. Estimated value and confidence interval reflect percentages.|The expected syncopal event free rate was 0.984 in both programming groups. alpha, Type I error was 0.05. Power, 1-beta, was 80%. Non-inferiority margin 5% Based on the above assumptions and Farrington-Manning test, a total of 230 subjects was required. By further assuming 15% attrition rate and 5 % of crossover rate, a total of 300 subjects were needed.||2.7|-2.7|0.0013
71032992|NCT02363803|141575425|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|Paired t-test||||||0.03
71032993|NCT03140631|141575430|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71032994|NCT03140631|141575431|SUPERIORITY|||||||0.74|||||||Fisher Exact|||number of participants who experienced a vascular access site complication at 90 days||||0.74
71032995|NCT02169115|141575432|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8|STANDARD_DEVIATION|1.7||0.05|TWO_SIDED||||||ANOVA|||||||0.05
71032996|NCT02169115|141575432|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.0|STANDARD_DEVIATION|1.8||0.005|TWO_SIDED||||||ANOVA|||||||0.005
71032997|NCT02169115|141575432|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_DEVIATION|1.4|||TWO_SIDED|||||||||||||
70921168|NCT04515641|141333393|OTHER||GMR|0.76|||||TWO_SIDED|90.0|0.57|1.0|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.00|0.57|
71032998|NCT02648438|141575467|SUPERIORITY_OR_OTHER||Geometric mean ratio|62.61|||||TWO_SIDED|90.0|53.01|73.94|||||Ratio (%)|Statistical Assessment of AZD7594 Pharmacokinetic Parameter (AUC0-t) Following Inhalation Administration ofAZD7594 via DPI Device 2 Versus DPI Device 1.||73.94|53.01|
70921169|NCT04515641|141333394|OTHER||GMR|0.77|||||TWO_SIDED|90.0|0.58|1.03|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.03|0.58|
71032999|NCT02648438|141575468|SUPERIORITY_OR_OTHER||Geometric mean ratio|101.15|||||TWO_SIDED|90.0|85.21|120.06|||||Ratio (%)|Statistical Assessment of AZD7594 Pharmacokinetic Parameter (AUC0-t) Following Inhalation Administration ofAZD7594 via DPI Device 2 Versus DPI Device 1.||120.06|85.21|
71033000|NCT04405570|141575493|SUPERIORITY|||||||0.5551|||||||Log Rank|||||||0.5551
71033001|NCT04405570|141575493|SUPERIORITY|||||||0.727|||||||Log Rank|||||||0.7270
71033002|NCT04405570|141575493|SUPERIORITY|||||||0.0128|||||||Log Rank|||||||0.0128
71033003|NCT04499963|141575497|SUPERIORITY|||||||0.984|||||||t-test, 2 sided|||We compared he ALSFRS-R slope (not the actual score) of the patients in our open label treatment versus the historical controls.||||0.984
71033004|NCT04499963|141575502|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
71033005|NCT04499963|141575503|OTHER||||||>|0.5||||||Alpha Diversity|Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.5
71033006|NCT04499963|141575504|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
71033007|NCT04499963|141575505|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
71033008|NCT04499963|141575506|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
71033009|NCT04499963|141575507|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
71033010|NCT04499963|141575508|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
71033011|NCT04499963|141575509|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
71033012|NCT03226522|141575526|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.010
71033013|NCT03226522|141575526|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71033014|NCT00984126|141575527|SUPERIORITY_OR_OTHER||Incidence rate|0.0|||||ONE_SIDED|95.0||1.4||||||A one-sided 95% upper confidence limit was based on an exact calculation for a binomial distribution.||1.4||
70974019|NCT00848354|141455044|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 4.||||<0.0001
70974020|NCT00848354|141455044|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0002
70974021|NCT00848354|141455044|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 12.||||0.0007
70974022|NCT00848354|141455044|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0001
70974023|NCT00848354|141455044|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 20.||||<0.0001
70974024|NCT00848354|141455044|SUPERIORITY_OR_OTHER|||||||0.0021|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||0.0021
71154165|NCT02962102|141801011|SUPERIORITY|||||||0.52|||||||Fisher Exact|||||||0.52
70921170|NCT04515641|141333395|OTHER||GMR|0.96|||||TWO_SIDED|90.0|0.63|1.46|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.46|0.63|
70921171|NCT04515641|141333396|OTHER||GMR|1.05|||||TWO_SIDED|90.0|0.65|1.71|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.71|0.65|
70921172|NCT04515641|141333397|OTHER||GMR|0.86|||||TWO_SIDED|90.0|0.59|1.26|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.26|0.59|
70921173|NCT04515641|141333398|OTHER||GMR|0.65|||||TWO_SIDED|90.0|0.42|1.01|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.01|0.42|
70921174|NCT00780234|141333408|OTHER||Regression model parameter (α1)|-0.4|STANDARD_ERROR_OF_MEAN|0.63||0.53|TWO_SIDED|95.0|-1.68|0.89|||Regression, Linear|The estimates of treatment effect were adjusted for baseline histology values.||"The hypotheses tested were:~H0: α1 = 0 vs H1: α1 \~= 0"|The hypothesis test was a 2-sided t-test of the effect of group (i.e. the difference between the pioglitazone and placebo groups). The general form of the model is Y = α0 + α1GROUP + α2BASELINE. Y represents the 6-month value of the dependent variable (summary of the histology), GROUP represents a classification variable for the treatment group (1=pioglitazone, 2=placebo), BASELINE represents the value of the outcome measure at baseline, and α0, α1 and α2 represent the parameter estimates from the general linear model. The test of the difference between groups will be the formal test of significance of the α1 parameter.|0.89|-1.68|0.53
70921175|NCT02178098|141333409|SUPERIORITY||Least squares mean difference|-24.24|STANDARD_ERROR_OF_MEAN|3.08|<|0.0001|TWO_SIDED|95.0|-30.33|-18.15|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-18.15|-30.33|<0.0001
70921176|NCT02178098|141333410|SUPERIORITY||Least squares mean difference|-1.64|STANDARD_ERROR_OF_MEAN|1.511||0.2808|TWO_SIDED|95.0|-4.62|1.35|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||1.35|-4.62|0.2808
70921177|NCT02178098|141333411|SUPERIORITY||Least squares mean difference|-1.05|STANDARD_ERROR_OF_MEAN|1.111||0.3461|TWO_SIDED|95.0|-3.25|1.15|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||1.15|-3.25|0.3461
70921178|NCT02178098|141333412|SUPERIORITY||Least squares mean difference|-2.31|STANDARD_ERROR_OF_MEAN|1.734||0.1852|TWO_SIDED|95.0|-5.74|1.12|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||1.12|-5.74|0.1852
70921179|NCT02178098|141333413|SUPERIORITY||Least squares mean difference|-1.45|STANDARD_ERROR_OF_MEAN|1.253||0.2481|TWO_SIDED|95.0|-3.93|1.03|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||1.03|-3.93|0.2481
70921180|NCT02178098|141333414|SUPERIORITY||Least squares mean difference|-0.39|STANDARD_ERROR_OF_MEAN|1.684||0.8181|TWO_SIDED|95.0|-3.72|2.94|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||2.94|-3.72|0.8181
70974025|NCT00848354|141455045|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0001
71154166|NCT02962102|141801011|SUPERIORITY|||||||0.58|||||||Fisher Exact|||||||0.58
71154167|NCT02962102|141801012|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.20
71154168|NCT02962102|141801012|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.20
71154169|NCT02962102|141801013|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||||||0.44
71154170|NCT02962102|141801013|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
71033015|NCT01001208|141575531|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||<0.0001
71033016|NCT01001208|141575532|SUPERIORITY_OR_OTHER|||||||0.0112||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0112
70974026|NCT00848354|141455045|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||<0.0001
70974027|NCT00848354|141455045|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||0.0003
70974028|NCT00848354|141455047|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||<0.0001
70974029|NCT00848354|141455047|SUPERIORITY_OR_OTHER|||||||0.0264|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0264
70974030|NCT00848354|141455047|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||0.0002
70974031|NCT00848354|141455049|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0005
70974032|NCT00848354|141455049|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||<0.0001
70974033|NCT00848354|141455049|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
70974034|NCT00848354|141455051|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 8, Week 16, and Week 24 - independently).||||<0.0001
70974035|NCT00848354|141455052|SUPERIORITY_OR_OTHER|||||||0.0061|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0061
70974036|NCT00848354|141455052|SUPERIORITY_OR_OTHER|||||||0.073|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0730
70974037|NCT00848354|141455052|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
70974038|NCT00848354|141455053|SUPERIORITY_OR_OTHER|||||||0.0066|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0066
71033017|NCT01001208|141575533|SUPERIORITY_OR_OTHER|||||||0.0112||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0112
71033018|NCT01001208|141575534|SUPERIORITY_OR_OTHER|||||||0.0112||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0112
71033019|NCT01001208|141575535|SUPERIORITY_OR_OTHER|||||||0.0112||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0112
71033020|NCT01001208|141575536|SUPERIORITY_OR_OTHER|||||||0.0112||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0112
71033021|NCT01001208|141575537|SUPERIORITY_OR_OTHER|||||||0.0348||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0348
70974039|NCT00848354|141455053|SUPERIORITY_OR_OTHER|||||||0.0036|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0036
70974040|NCT00848354|141455053|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
70974041|NCT00848354|141455054|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||<0.0001
71033022|NCT01001208|141575538|SUPERIORITY_OR_OTHER|||||||0.0112||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0112
71033023|NCT01001208|141575539|SUPERIORITY_OR_OTHER|||||||0.1995||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|2-sided van Elteren test|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.1995
71033024|NCT01001208|141575540|SUPERIORITY_OR_OTHER|||||||0.1995||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|2-sided van Elteren test|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.1995
71033025|NCT01864174|141575541|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The study provided 90% power to demonstrate noninferiority in change from baseline mean HbA1c at Week 24, with an assumed standard deviation (SD) of 1.0%, a non-inferiority margin of 0.3%, and 2-sided alpha of 0.05 for the primary comparison|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.0687|||TWO_SIDED|95.0|-0.1|0.17|||||METFORMIN XR VS METFORMIN IR|||0.17|-0.10|
71033026|NCT00840411|141575624|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.0||||||90.0|93.3|107.1|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107.1|93.3|
71033027|NCT00840411|141575625|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Least Squares Means|86.5||||||90.0|80.1|93.4|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||93.4|80.1|
71033028|NCT00840411|141575626|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Least Squares Means|87.2||||||90.0|81.0|93.8|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||93.8|81.0|
71154171|NCT03100149|141801023|SUPERIORITY||Difference in Adjusted Means|-2.02|STANDARD_ERROR_OF_MEAN|1.71||0.2385|TWO_SIDED|80.0|-4.21|0.18|||Mixed Models Analysis|||||0.18|-4.21|0.2385
71033029|NCT01985308|141575628|SUPERIORITY|||||||0.0002|||||||t-test, 2 sided|||||||0.0002
71033030|NCT01854047|141575636|SUPERIORITY||Least Square (LS) Mean Difference|0.21||||0.0063|TWO_SIDED|95.0|0.06|0.36||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 300 mg q2w vs. Placebo q2w|Analysis was performed using mixed effect model with repeated measures (MMRM) approach including available FEV1 data from baseline to Week 12 and treatment group as a factor. A step-down procedure was used to strongly control the overall type I error rate for testing multiple doses against placebo. The hierarchy was 300 mg q2w, 200 mg q2w, 300 mg q4w, and 200 mg q4w.||0.36|0.06|0.0063
71154172|NCT03100149|141801023|SUPERIORITY||Difference in Adjusted Means|-0.62|STANDARD_ERROR_OF_MEAN|1.71||0.7169|TWO_SIDED|80.0|-2.82|1.58|||Mixed Models Analysis|||||1.58|-2.82|0.7169
71033031|NCT01854047|141575636|SUPERIORITY||LS Mean Difference|0.26||||0.0008|TWO_SIDED|95.0|0.11|0.4||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 200 mg q2w vs. Placebo q2w|||0.40|0.11|0.0008
71033032|NCT01854047|141575636|SUPERIORITY||LS Mean Difference|0.17||||0.0212|TWO_SIDED|95.0|0.03|0.32||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 300 mg q4w vs. Placebo q2w|||0.32|0.03|0.0212
71033033|NCT01854047|141575636|SUPERIORITY||LS Mean Difference|0.08||||0.2774|TWO_SIDED|95.0|-0.07|0.23||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 200 mg q4w vs. Placebo q2w|||0.23|-0.07|0.2774
71033034|NCT01854047|141575637|SUPERIORITY||LS Mean Difference|0.16||||0.0002|TWO_SIDED|95.0|0.08|0.25||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 300 mg q2w vs. Placebo q2w|Analysis was performed using MMRM approach including available FEV1 data from baseline to Week 12 and treatment group as a factor. A step-down procedure was used to strongly control the overall type I error rate for testing multiple doses against placebo. The hierarchy was 300 mg q2w, 200 mg q2w, 300 mg q4w and 200 mg q4w.||0.25|0.08|0.0002
71033035|NCT01854047|141575637|SUPERIORITY||LS Mean Difference|0.2|||<|0.0001|TWO_SIDED|95.0|0.011|0.28||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 200 mg q2w vs. Placebo q2w|||0.28|0.011|<0.0001
71033036|NCT01854047|141575637|SUPERIORITY||LS Mean Difference|0.12||||0.0048|TWO_SIDED|95.0|0.04|0.21||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 300 mg q4w vs. Placebo q2w|||0.21|0.04|0.0048
71033037|NCT01854047|141575637|SUPERIORITY||LS Mean Difference|0.1||||0.0304|TWO_SIDED|95.0|0.01|0.18||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 200 mg q4w vs. Placebo q2w|||0.18|0.01|0.0304
71033038|NCT02847650|141575667|OTHER||Least Squares Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|2.26||0.0407|TWO_SIDED|90.0|-8.6|-1.0|||Mixed Models Analysis|||||-1.0|-8.6|0.0407
71033039|NCT03818581|141575675|SUPERIORITY|||||||0.15|||||||SPCD analysis|||||||0.15
70974042|NCT00848354|141455054|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0013
70974043|NCT00848354|141455054|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||0.0002
70974044|NCT00848354|141455055|SUPERIORITY_OR_OTHER|||||||0.0021|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0021
71033040|NCT01281501|141575704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6|STANDARD_DEVIATION|5.0||0.6|TWO_SIDED|95.0|-12.7|7.4|||t-test, 2 sided|||Null hypothesis is that the treatment with pantoprazole arm is not different in immediate relief of acute, severe dyspeptic pain compared with conventional arm.||7.4|-12.7|0.6
71033041|NCT02996591|141575738|OTHER||generalized estimating equations method|45.0||||0.038|TWO_SIDED||||||Regression, Logistic|||||||.038
71033042|NCT02996591|141575738|OTHER|Bang blinding index|||||<|0.001|||||||Bang Blinding Index|95% confidence interval||||||<.001
71033043|NCT00461786|141575749|SUPERIORITY_OR_OTHER||Overall Response Rate|21.0||||||95.0|10.5|35.0||||||Overall Response Rate is the total percentage of participants with either a complete response or a partial response (CR+PR)/48 X 100.||35.0|10.5|
71033044|NCT00835991|141575755|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|114.05||||||90.0|107.26|121.27|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||121.27|107.26|
71033045|NCT00835991|141575756|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.63||||||90.0|97.59|103.76|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.76|97.59|
71095097|NCT04621760|141698454|SUPERIORITY|||||||0.1||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.||||0.10
70921181|NCT02178098|141333415|SUPERIORITY||Least squares mean difference|0.19|STANDARD_ERROR_OF_MEAN|1.274||0.8817|TWO_SIDED|95.0|-2.33|2.71|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||2.71|-2.33|0.8817
70921182|NCT02178098|141333416|SUPERIORITY||Least squares mean difference|1.53|STANDARD_ERROR_OF_MEAN|1.829||0.404|TWO_SIDED|95.0|-2.09|5.15|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||5.15|-2.09|0.4040
70921183|NCT02178098|141333417|SUPERIORITY||Least squares mean difference|0.79|STANDARD_ERROR_OF_MEAN|1.178||0.5061|TWO_SIDED|95.0|-1.54|3.11|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||3.11|-1.54|0.5061
70921184|NCT02178098|141333418|SUPERIORITY||Median Difference (Final Values)|-43.64|||<|0.0001|TWO_SIDED|95.0|-62.8|-25.21|||Wilcoxon Rank-Sum Test||The 95% confidence interval (CI) was calculated using Hodges-Lehmann analysis.|||-25.21|-62.80|<0.0001
71033046|NCT00835991|141575757|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|101.36||||||90.0|98.32|104.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.48|98.32|
71033047|NCT00835991|141575758|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|99.05||||||90.0|94.31|104.02|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.02|94.31|
71033048|NCT00835991|141575759|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05|Test/Ref Ratio of LS Means x 100|96.55||||||90.0|93.85|99.32|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.32|93.85|
71033049|NCT00835991|141575760|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.44||||||90.0|93.71|99.25|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.25|93.71|
71033050|NCT02149420|141575761|SUPERIORITY||Mean Difference (Final Values)|-0.93|STANDARD_DEVIATION|2.058||0.678|TWO_SIDED|95.0|-5.007|3.18|||repeated measures Bayesian analysis|with baseline as a covariate||Per protocol the primary analysis was between placebo and the combined VAY736 groups at Week 12.||3.180|-5.007|0.678
70921185|NCT02178098|141333419|SUPERIORITY||Least squares mean difference|-16.67|STANDARD_ERROR_OF_MEAN|2.006|<|0.0001|TWO_SIDED|95.0|-20.63|-12.7|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-12.70|-20.63|<0.0001
70921186|NCT02178098|141333420|SUPERIORITY||Least squares mean difference|-18.9|STANDARD_ERROR_OF_MEAN|2.624|<|0.0001|TWO_SIDED|95.0|-24.09|-13.71|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-13.71|-24.09|<0.0001
70921187|NCT02178098|141333421|SUPERIORITY||Least squares mean difference|-18.69|STANDARD_ERROR_OF_MEAN|2.49|<|0.0001|TWO_SIDED|95.0|-23.62|-13.77|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-13.77|-23.62|<0.0001
70921188|NCT02178098|141333422|SUPERIORITY||Median Difference (Final Values)|5.25||||0.3689|TWO_SIDED|95.0|-6.78|16.42|||Wilcoxon Rank-Sum Test||The 95% CI was calculated using Hodges-Lehmann analysis.|||16.42|-6.78|0.3689
70974045|NCT00848354|141455055|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||<0.0001
71033051|NCT03612960|141575775|SUPERIORITY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|0.14|0.43|||t-test, 2 sided||||The mean percent change in BOLD signal used for this t-test was extracted from a brain cluster with significant group differences in changes in activation over time (voxel p\<.05, cluster p\<.05) identified using a whole-brain, voxel-wise two-way mixed effect ANOVA with FSL software.|0.43|0.14|<.001
70921189|NCT02178098|141333423|SUPERIORITY||Least squares mean difference|-8.18|STANDARD_ERROR_OF_MEAN|2.319||0.0006|TWO_SIDED|95.0|-12.76|-3.59|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-3.59|-12.76|0.0006
70921190|NCT02178098|141333424|SUPERIORITY||Median Difference (Final Values)|7.6||||0.3093|TWO_SIDED|95.0|-8.21|24.02|||Wilcoxon Rank-Sum Test||The 95% CI was calculated using Hodges-Lehmann analysis.|||24.02|-8.21|0.3093
70921191|NCT02382744|141333455|SUPERIORITY_OR_OTHER||Difference between proportions (%)|10.0||||0.25|TWO_SIDED|95.0|-11.9|31.9||One-sided P-value based on the lack of plausibility that additional nerve stimulation would worsen sensory blockade rates.|Fisher Exact|||We sought to detect an increase in the rate of complete absence of sensation to pinprick 30 min following ultrasound-guided subsartorial saphenous nerve blockade to 90% from an assumed baseline of 64% as extrapolated from our previous study (cf. Head SJ et al. 2015) at β = 0.2. The required minimum sample size at α = 0.05 (one-sided) was 30 patients in each group. To be conservative, we aimed to enroll a total of 80 patients.||31.9|-11.9|0.25
70921192|NCT02382744|141333456|SUPERIORITY_OR_OTHER|||||||0.62||||||Two-sided P-value|Fisher Exact|||"This contingency-table type analysis (Fisher Exact test) compares the two groups, Ultrasound Guidance and Ultrasound Guidance and Nerve Stimulation, as far as the two categorical outcomes are concerned, block failure at 30 minutes post nerve block versus no block failure at 30 minutes post nerve block."||||0.62
70921193|NCT02382744|141333457|SUPERIORITY_OR_OTHER|||||||0.62|||||||Fisher Exact|||||||0.62
70921194|NCT02382744|141333458|SUPERIORITY_OR_OTHER|||||||0.26||||||Two-sided P-value|Fisher Exact|||"This contingency-table type analysis (Fisher Exact test) compares the two groups, Ultrasound Guidance and Ultrasound Guidance and Nerve Stimulation, as far as the two categorical outcomes are concerned, incomplete block at 30 minutes post nerve block versus no incomplete block at 30 minutes post nerve block."||||0.26
70921195|NCT02382744|141333459|SUPERIORITY_OR_OTHER||"Median survival ratio"|0.7||||0.12|TWO_SIDED|95.0|0.38|1.31|||Log Rank||"Numerator, group Ultrasound Guidance; denominator, group, Ultrasound Guidance + Nerve Stimulation"|"To assess speed of onset, sensation to pinprick in the distribution of the saphenous nerve was assessed for each patient every 5 min until complete sensory loss was noted, or until 30 min had elapsed. To compare the two groups in speed of onset on the basis of these data, we constructed Kaplan-Meyer survival curves for the times to onset of sensory blockade and compared the underlying time-to-event data with the log-rank test."||1.31|0.38|0.12
70921196|NCT02382744|141333463|SUPERIORITY_OR_OTHER||Difference between means (s)|107.0|||<|0.0001|TWO_SIDED|95.0|61.0|153.0|||t-test, 2 sided|||||153|61|<0.0001
70921197|NCT02382744|141333466|SUPERIORITY_OR_OTHER||"Median survival ratio"|0.58||||0.02|TWO_SIDED|95.0|0.37|0.93|||Log Rank||"Numerator, group Ultrasound Guidance; denominator, group, Ultrasound Guidance + Nerve Stimulation"|||0.93|0.37|0.02
70921198|NCT02382744|141333469|SUPERIORITY_OR_OTHER|||||||0.0057|||||||Fisher Exact|||"This contingency-table type analysis (Fisher Exact test) compares the two arms, Patients with response to nerve stimulation and Patients with lack response to nerve stimulation, as far as the two categorical outcomes are concerned, block failure at 30 minutes post nerve block versus no block failure at 30 minutes post nerve block."||||0.0057
70921199|NCT01553058|141333481|OTHER|Difference of Differences||||||0.795|||||||Regression, Linear|||||||0.795
70921200|NCT01553058|141333481|OTHER|Difference of differences||||||0.647|||||||Regression, Linear|||||||0.647
71033052|NCT03612960|141575776|SUPERIORITY||Mean Difference (Final Values)|-8.38|STANDARD_ERROR_OF_MEAN|4.33||0.063|TWO_SIDED|95.0|-17.24|0.48|||t-test, 2 sided|||||0.48|-17.24|.063
71033053|NCT03612960|141575777|SUPERIORITY||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|9.86||0.89|TWO_SIDED|95.0|-21.57|18.82|||t-test, 2 sided|||||18.82|-21.57|0.890
71095098|NCT04621760|141698455|SUPERIORITY|||||||0.22||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong negative skew of responses, transformed into a binary variable comparing those with highest possible score versus higher score. Data then tested through tests of proportions.||||0.22
71095099|NCT04621760|141698456|SUPERIORITY|||||||0.51||||||a priori threshold for significance: 0.05|Fisher Exact|Fisher's exact test used due to small cell size||||||0.51
71095100|NCT04621760|141698457|SUPERIORITY|||||||0.9||||||a priori threshold for significance: 0.05|Fisher Exact|||Comparing confidence between treatment groups of those who said they intended to use PrEP||||0.90
71095101|NCT04621760|141698457|SUPERIORITY|||||||0.75||||||a priori threshold for significance: 0.05|Fisher Exact|||Comparing confidence between treatment groups of those who said they intended to use abstinence||||0.75
70921201|NCT01553058|141333482|OTHER|Difference of differences||||||0.386|||||||Regression, Linear|||||||0.386
70921202|NCT01553058|141333482|OTHER|Difference of Differences||||||0.28|||||||Regression, Linear|||||||0.280
70921203|NCT01553058|141333489|OTHER|Difference of Differences||||||0.357|||||||Regression, Linear|||||||0.357
70921204|NCT01553058|141333489|OTHER|Difference of Differences||||||0.496|||||||Regression, Linear|||||||0.496
70921205|NCT01553058|141333490|OTHER|Difference of Differences||||||0.897|||||||Regression, Linear|||||||0.897
70921206|NCT01553058|141333490|OTHER|Difference of differences||||||0.467|||||||Regression, Linear|||||||0.467
70921207|NCT01553058|141333491|OTHER|Difference of differences||||||0.089|||||||Regression, Linear|||||||0.089
70921208|NCT01553058|141333491|OTHER|Difference of differences||||||0.03|||||||Regression, Linear|||||||0.030
70921209|NCT01553058|141333492|OTHER|Difference of differences||||||0.934|||||||Regression, Linear|||||||0.934
70921210|NCT01553058|141333492|OTHER|Difference of differences||||||0.679|||||||Regression, Linear|||||||0.679
70921211|NCT01553058|141333493|OTHER|Difference of differences||||||0.672|||||||Regression, Linear|||||||0.672
70921212|NCT01553058|141333493|OTHER|Difference of differences||||||0.655|||||||Regression, Linear|||||||0.655
70921213|NCT01553058|141333494|OTHER|Difference of differences||||||0.504|||||||Regression, Linear|||||||0.504
70921214|NCT01553058|141333494|OTHER|Difference of differences||||||0.695|||||||Regression, Linear|||||||0.695
71095102|NCT04621760|141698457|SUPERIORITY|||||||0.32||||||a priori threshold for significance: 0.05|Fisher Exact|||Comparing confidence between treatment groups of those who said they intended to use PEP||||0.32
70921215|NCT01553058|141333495|OTHER|Difference of differences||||||0.002|||||||Regression, Linear|||||||0.002
70921216|NCT01553058|141333495|OTHER|Difference of differences||||||0.009|||||||Regression, Linear|||||||0.009
70921217|NCT01553058|141333496|OTHER|Difference of Differences|||||<|0.001|||||||Regression, Linear|||||||<0.001
70921218|NCT01553058|141333496|OTHER|Difference of differences||||||0.065|||||||Regression, Linear|||||||0.065
70921219|NCT01553058|141333497|OTHER|Difference of differences||||||0.007|||||||Regression, Linear|||||||0.007
70921220|NCT01553058|141333497|OTHER|Difference of differences||||||0.019|||||||Regression, Linear|||||||0.019
70921221|NCT01553058|141333498|OTHER|Difference of differences||||||0.006|||||||Regression, Linear|||||||0.006
70921222|NCT01553058|141333498|OTHER|Difference of differences||||||0.628|||||||Regression, Linear|||||||0.628
70921223|NCT03087708|141333552|OTHER||||||<|1|||||||Fisher Exact|||Comparison of Hematologic 3+ vs Hematologic \<3||||<1
70921224|NCT03087708|141333552|OTHER||||||<|0.7051|||||||Fisher Exact|||Comparison of Non-Hematologic 3+ vs Non-Hematologic \<3||||<0.7051
70921225|NCT03087708|141333552|OTHER||||||<|0.6546|||||||Fisher Exact|||Comparison of Hematologic 3+ vs Hematologic \<3||||<0.6546
70921226|NCT03087708|141333552|OTHER||||||<|0.7051|||||||Fisher Exact|||Comparison of Non-Hematologic 3+ vs Non-Hematologic \<3||||<0.7051
70921227|NCT03087708|141333552|OTHER||||||<|0.2262|||||||Fisher Exact|||Comparison of Non-Hematologic 3+ vs Non-Hematologic \<3||||<0.2262
70921228|NCT03087708|141333552|OTHER||||||<|1|||||||Fisher Exact|||Comparison of Hematologic 3+ vs Hematologic \<3||||<1
70921229|NCT03087708|141333552|OTHER||||||<|1|||||||Fisher Exact|||Comparison of Non-Hematologic 3+ vs Non-Hematologic \<3||||<1
70921230|NCT03087708|141333556|OTHER||||||<|0.68182|||||||Fisher Exact|||||||<0.68182
70921231|NCT03087708|141333556|OTHER||||||<|0.1091|||||||Fisher Exact|||||||<0.1091
70921232|NCT03087708|141333557|OTHER||||||<|1|||||||Wilcoxon (Mann-Whitney)|||||||<1.0
70921233|NCT03087708|141333557|OTHER||||||<|0.3339|||||||Wilcoxon (Mann-Whitney)|||||||<0.3339
70921234|NCT03087708|141333558|OTHER||||||<|0.593|||||||Wilcoxon (Mann-Whitney)|||||||<0.5930
70921235|NCT03087708|141333558|OTHER||||||<|0.3105|||||||Wilcoxon (Mann-Whitney)|||||||<0.3105
70921236|NCT03087708|141333559|OTHER|||||||0.6024|||||||Wilcoxon (Mann-Whitney)|||Average Pain Scores at Baseline||||0.6024
70921237|NCT03087708|141333559|OTHER||||||<|0.3116|||||||Wilcoxon (Mann-Whitney)|||Average Pain Scores at Baseline||||<0.3116
70921238|NCT03087708|141333559|OTHER||||||<|0.7712|||||||Wilcoxon (Mann-Whitney)|||Average Pain Scores at 6 Months||||<0.7712
70921239|NCT03087708|141333559|OTHER||||||<|1|||||||Wilcoxon (Mann-Whitney)|||Average Pain Scores at 6 Months||||<1.0
70921240|NCT03087708|141333560|OTHER||||||<|1|||||||Fisher Exact|||Analgesic Use at 6 Months||||<1.0000
70921241|NCT03087708|141333560|OTHER||||||<|0.5758|||||||Fisher Exact|||Analgesic Use at 6 Months||||<0.5758
70921242|NCT03087708|141333560|OTHER||||||<|1|||||||Fisher Exact|||Analgesic use at Baseline||||<1.0000
70921243|NCT03087708|141333560|OTHER|||||||0.593|||||||Fisher Exact|||Analgesic use at Baseline||||0.5930
70921244|NCT01303445|141333565|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|92.03||||||90.0|86.95|97.4||||||Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone||97.40|86.95|
70921245|NCT01303445|141333565|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|92.3||||||90.0|87.76|97.08||||||Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone||97.08|87.76|
70921246|NCT01303445|141333566|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|96.38||||||90.0|90.96|102.13||||||Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone||102.13|90.96|
70921247|NCT01303445|141333566|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|97.03||||||95.0|93.26|100.95||||||Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone||100.95|93.26|
70921248|NCT01303445|141333567|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|99.02||||||90.0|98.32|99.72||||||Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone||99.72|98.32|
70921249|NCT01303445|141333567|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|98.42||||||90.0|97.66|99.18||||||Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone||99.18|97.66|
70921250|NCT01303445|141333568|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|105.55||||||90.0|97.09|114.74||||||Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone||114.74|97.09|
70921251|NCT01303445|141333568|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|106.09||||||90.0|98.64|114.09||||||Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone||114.09|98.64|
70921252|NCT01303445|141333569|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|99.38||||||90.0|98.8|99.95||||||Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone||99.95|98.80|
70921253|NCT01303445|141333569|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|99.02||||||90.0|98.46|99.59||||||Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone||99.59|98.46|
70921254|NCT04994509|141333578|SUPERIORITY||Rate Ratio|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.042||p-value for rate ratio vs bHIV is from likelihood ratio test.|Likelihood ratio test||Confidence Interval (CI) for rate ratio vs bHIV is from a likelihood-based method.|Null Hypothesis 01: LEN/bHIV\>= 1; Null hypothesis was to be rejected if HIV-1 incidence in LEN was significantly lower than bHIV.||0.042|0.000|<0.0001
70921255|NCT04994509|141333578|SUPERIORITY||Rate Ratio|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.042||p-value for rate ratio vs bHIV is from likelihood ratio test.|Likelihood ratio test||CI for rate ratio vs bHIV is based on a likelihood-based method.|Null Hypothesis 02: LEN/bHIV\>= 0.8; Null hypothesis was to be rejected if HIV-1 incidence in LEN was significantly and at least 20% lower than bHIV.||0.042|0.000|<0.0001
70921256|NCT04994509|141333578|SUPERIORITY||Rate Ratio|0.839||||0.20697|TWO_SIDED|95.0|0.55|1.279||p-value for rate ratio vs bHIV is from Wald test.|Wald test||CI for rate ratio vs bHIV is based on the delta method.|Null Hypothesis 03: F/TAF/bHIV\>= 1; Null hypothesis was to be rejected if HIV-1 incidence in F/TAF was significantly lower than bHIV.||1.279|0.550|0.20697
70921257|NCT04994509|141333578|SUPERIORITY||Rate Ratio|0.839||||0.58674|TWO_SIDED|95.0|0.55|1.279||p-value for rate ratio vs bHIV is from Wald test.|Wald test||CI for rate ratio vs bHIV is based on the delta method.|Null Hypothesis 04: F/TAF/bHIV\>= 0.8; Null hypothesis was to be rejected if HIV-1 incidence in F/TAF was significantly and at least 20% lower than bHIV.||1.279|0.550|0.58674
70921258|NCT04994509|141333579|SUPERIORITY||Rate Ratio|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.101||p-value for rate ratio vs F/TDF is from an exact conditional Poisson model.|Poisson model||CI is from an exact conditional Poisson model.|||0.101|0.000|< 0.0001
70921259|NCT04994509|141333579|SUPERIORITY||Rate Ratio|1.198||||0.7282|TWO_SIDED|95.0|0.669|2.143||p-value for rate ratio vs F/TDF is from a Poisson model.|Poisson model||CI is from a Poisson model.|||2.143|0.669|0.72820
70921260|NCT04994509|141333579|OTHER|Comparability to F/TDF is defined as the HIV-1 incidence in the LEN group at most 0.8/100 PY higher than in the F/TDF group.|Rate Difference|-1.685|||<|0.0001|TWO_SIDED|95.0|-2.737|-0.939||p-value for rate difference vs F/TDF is based on a hybrid approach.|Hybrid approach||Exact CI is based on a hybrid approach.|||-0.939|-2.737|<0.0001
70921261|NCT04994509|141333579|OTHER|Comparability to F/TDF is defined as the HIV-1 incidence in the F/TAF group at most 0.8/100 PY higher than in the F/TDF group.|Rate Difference|0.333||||0.209|TWO_SIDED|95.0|-0.869|1.367||p-value for rate difference vs F/TDF is based on a hybrid approach.|Hybrid approach||Exact CI is based on a hybrid approach.|||1.367|-0.869|0.20900
70921262|NCT04994509|141333581|SUPERIORITY||Exact Odds Ratio|9.0||||0.0006|TWO_SIDED|95.0|2.06|83.36||p-value is from exact conditional logistic regression model.|ExactConditionalLogisticRegressionModel||Exact odds ratio and and CI are from exact conditional logistic regression model.|||83.36|2.06|0.0006
70921263|NCT06546657|141333591|OTHER||Mean Difference (Final Values)|1.74||||0.14|TWO_SIDED|95.0|-0.6|4.0||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||Medium GI vs low GI breakfast meals||4.0|-0.6|0.14
70921264|NCT06546657|141333591|OTHER||Mean Difference (Final Values)|4.4||||0.01|TWO_SIDED|95.0|1.2|7.5|||Linear Mixed Model|||Medium vs high GI breakfast meals||7.5|1.2|0.01
70921265|NCT06546657|141333591|OTHER||Mean Difference (Final Values)|-2.63||||0.12|TWO_SIDED|95.0|-6.0|0.7||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||High GI vs low GI breakfast meals||0.7|-6.0|0.12
70921266|NCT06546657|141333592|OTHER||Mean Difference (Final Values)|0.1815||||0.65|TWO_SIDED||||||Linear Mixed Model|||High GI breakfast meals vs low and medium GI breakfast meals||||0.65
70921267|NCT06546657|141333593|OTHER||Mean Difference (Final Values)|0.431||||0.25|TWO_SIDED|95.0|-0.3|1.2|||Linear Mixed Model|||High glycaemic load breakfast meals vs low and medium glycaemic load meals||1.2|-0.3|0.25
70921268|NCT06546657|141333594|OTHER||Mean Difference (Final Values)|22.0||||0.04|TWO_SIDED|95.0|0.6|44.0|||Linear Mixed Model|||High glycaemic load breakfast meals vs low and medium glycaemic load meals||44|0.6|0.04
70921269|NCT06546657|141333595|OTHER||Mean Difference (Final Values)|1.3||||0.01|TWO_SIDED|95.0|0.4|2.1|||Linear Mixed Model|||Breakfast cereals meals vs added protein meals||2.1|0.4|0.01
70921270|NCT06546657|141333597|OTHER|Comparison of diurnal and nocturnal glucose variability (CV%)|Mean Difference (Final Values)|1.7|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
70921271|NCT05540535|141333605|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|The Wilcoxon signed-rank test was used for a within-group comparison.||||||<0.05
70921272|NCT05540535|141333606|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
70921273|NCT05540535|141333607|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|The Wilcoxon signed-rank test was used for a within-group comparison.||||||<0.05
70921274|NCT05540535|141333608|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
70921275|NCT05540535|141333609|SUPERIORITY|||||||0.05|||||||ANOVA|||||||0.05
70921276|NCT05540535|141333610|SUPERIORITY|||||||0.05|||||||ANOVA|||||||0.05
70921277|NCT05540535|141333611|SUPERIORITY|||||||0.05|||||||ANOVA|||||||0.05
70921278|NCT04714320|141333618|SUPERIORITY||||||=|0.135||||||The stratification factor (screening estimated glomerular filtration rate (eGFR) status \[\<60 vs. ≥60 mL/min/1.73 m\^2\]), treatment received, and baseline measure were included in the analysis of covariate (ANCOVA) model as independent variables.|ANCOVA|||Change From Baseline in Seated Automated Office SBP to Day 85||||=0.135
70921279|NCT04714320|141333618|SUPERIORITY||||||=|0.867||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change From Baseline in Seated Automated Office SBP to Day 85||||=0.867
70921280|NCT04714320|141333620|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change From Baseline at Day 15||||<0.001
70921281|NCT04714320|141333620|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change From Baseline at Day 15||||<0.001
70921282|NCT04714320|141333620|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 29||||<0.001
70921283|NCT04714320|141333620|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 29||||<0.001
70921284|NCT04714320|141333620|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 43||||<0.001
70921285|NCT04714320|141333620|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 43||||<0.001
70921286|NCT04714320|141333620|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 57||||<0.001
70921287|NCT04714320|141333620|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 57||||<0.001
70921288|NCT04714320|141333620|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 71||||<0.001
70921289|NCT04714320|141333620|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 71||||<0.001
70921290|NCT04714320|141333620|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 85||||<0.001
70921291|NCT04714320|141333620|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 85||||<0.001
70921292|NCT04714320|141333620|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 92||||<0.001
70921293|NCT04714320|141333620|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 92||||<0.001
70921294|NCT04714320|141333620|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 106||||<0.001
70921295|NCT04714320|141333620|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 106||||<0.001
70974046|NCT00848354|141455055|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
70974047|NCT00848354|141455056|SUPERIORITY_OR_OTHER|||||||0.0062|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0062
70974048|NCT00848354|141455056|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0007
70974049|NCT00848354|141455056|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
71095103|NCT04621760|141698457|SUPERIORITY|||||||0.4||||||a priori threshold for significance: 0.05|Fisher Exact|||Comparing confidence between treatment groups of those who said they intended to use HIV testing||||0.40
70921296|NCT04714320|141333620|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables|ANCOVA|||Change from Baseline at Day 120||||<0.001
70921297|NCT04714320|141333620|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables|ANCOVA|||Change from Baseline at Day 120||||<0.001
70921298|NCT04714320|141333620|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 148||||<0.001
70921299|NCT04714320|141333620|SUPERIORITY||||||=|0.002||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 148||||=0.002
70921300|NCT04714320|141333620|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 169||||<0.001
70921301|NCT04714320|141333620|SUPERIORITY||||||=|0.002||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 169||||=0.002
70921302|NCT04714320|141333621|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 15||||<0.001
70921303|NCT04714320|141333621|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 15||||<0.001
70921304|NCT04714320|141333621|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day at 29||||<0.001
70921305|NCT04714320|141333621|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day at 29||||<0.001
70921306|NCT04714320|141333621|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 43||||<0.001
70921307|NCT04714320|141333621|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 43||||<0.001
70921308|NCT04714320|141333621|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 57||||<0.001
70921309|NCT04714320|141333621|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 57||||<0.001
70921310|NCT04714320|141333621|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 71||||<0.001
70921311|NCT04714320|141333621|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 71||||<0.001
70921312|NCT04714320|141333621|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 85||||<0.001
70921313|NCT04714320|141333621|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 85||||<0.001
70921314|NCT04714320|141333621|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 92||||<0.001
70921315|NCT04714320|141333621|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received were included in the Van Elteren model as independent variables|Van Elteren|||Percent Change from Baseline at Day 92||||<0.001
70921316|NCT04714320|141333621|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 106||||<0.001
70921317|NCT04714320|141333621|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 106||||<0.001
70921318|NCT04714320|141333621|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 120||||<0.001
70921319|NCT04714320|141333621|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 120||||<0.001
70921320|NCT04714320|141333621|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 148||||<0.001
70921321|NCT04714320|141333621|SUPERIORITY||||||=|0.005||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 148||||=0.005
70921322|NCT04714320|141333621|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 169||||<0.001
70921323|NCT04714320|141333621|SUPERIORITY||||||=|0.002||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 169||||=0.002
70921324|NCT04714320|141333622|SUPERIORITY||||||=|0.094||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline in 24-hour Mean SBP at Day 85||||=0.094
70921325|NCT04714320|141333622|SUPERIORITY||||||=|0.842||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline in 24-hour Mean SBP at Day 85||||=0.842
70921326|NCT04714320|141333622|SUPERIORITY||||||=|0.066||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change From Baseline in 24-hour Mean DBP at Day 85||||=0.066
71033054|NCT00272779|141575784|SUPERIORITY_OR_OTHER||Difference Estimate|1.7|||||TWO_SIDED|95.0|-3.8|7.1||Assuming 70% response rate (70% of participants remain on treatment for 48 wks and HIV RNA \<50 copies/mL) on both regimens, sample size of 882 randomized participants (441/regimen) provided 90% power to demonstrate ATV/RTV is non-inferior to LPV/RTV|Cochran-Mantel-Haenszel|The ATV/RTV regimen was deemed to be non-inferior to the lopinavir/ritonavir regimen if the lower CI for the difference in proportions \> -10%.||Treatment regimens compared by calculation of the difference in proportions (atazanavir/ritonavir- lopinavir/ritonavir) and 95% CI based on stratified normal approximation.Analyses were stratified by the same strata as randomization-HIV RNA level at enrollment and geographic region.The proportion of participants with HIV RNA below 50 copies/mL was computed within each stratum, and combined by use of a weighted average with weights proportional to stratum size:Cochran-Mantel-Haenszel weighting||7.1|-3.8|
71033055|NCT00272779|141575785|SUPERIORITY_OR_OTHER||Difference Estimate|3.3|||||TWO_SIDED|95.0|-1.5|8.1|||Cochran-Mantel-Haenszel|||Treatment regimens were compared by calculation of the difference in proportions (ATV/RTV-LPV/RTV) and 95% CI based on a stratified normal approximation. Analyses were stratified by the same strata as randomization-ie, HIV RNA level at enrollment and geographic region. The proportion of participants with HIV RNA below 400 copies per mL was computed within each stratum, and combined by use of a weighted average with weights proportional to stratum size (Cochran-Mantel-Haenszel weighting).||8.1|-1.5|
71033056|NCT00272779|141575788|SUPERIORITY_OR_OTHER||Difference Estimate|-16.4|||||TWO_SIDED|95.0|-35.9|3.1|||95% CI comparison of difference|||Mean changes in CD4 cell counts from baseline at week 48 were compared between treatment regimens with 95% CIs based on stratified normal approximations and observed values.||3.1|-35.9|
71033057|NCT00272779|141575810|SUPERIORITY_OR_OTHER||Difference Estimate|6.1|||||TWO_SIDED|95.0|0.3|12.0||Assuming 70% response rate (70% of participants remain on treatment for 96 wks and HIV RNA \<50 copies/mL) on both regimens, sample size of 882 randomized participants (441/regimen) provided 90% power to demonstrate ATV/RTV is non-inferior to LPV/RTV|Cochran-Mantel-Haenszel|The ATV/RTV regimen was deemed to be non-inferior to the lopinavir/ritonavir regimen if the lower CI for the difference in proportions \> -10%.||Treatment regimens compared by calculation of the difference in proportions (atazanavir/ritonavir- lopinavir/ritonavir) and 95% CI based on stratified normal approximation.Analyses were stratified by the same strata as randomization-HIV RNA level at enrollment and geographic region.The proportion of participants with HIV RNA below 50 copies/mL was computed within each stratum, and combined by use of a weighted average with weights proportional to stratum size:Cochran-Mantel-Haenszel weighting||12.0|0.3|
71033058|NCT00272779|141575811|SUPERIORITY_OR_OTHER||Difference Estimate|5.1|||||TWO_SIDED|95.0|-0.4|10.6|||Cochran-Mantel-Haenszel|||Treatment regimens were compared by calculation of the difference in proportions (ATV/RTV-LPV/RTV) and 95% CI based on a stratified normal approximation. Analyses were stratified by the same strata as randomization-ie, HIV RNA level at enrollment and geographic region. The proportion of participants with HIV RNA below 400 copies per mL was computed within each stratum, and combined by use of a weighted average with weights proportional to stratum size (Cochran-Mantel-Haenszel weighting).||10.6|-0.4|
71033059|NCT00272779|141575813|SUPERIORITY_OR_OTHER||Difference Estimate|-21.2|||||TWO_SIDED|95.0|-43.3|0.9|||95% CI comparison of difference|||Mean changes in CD4 cell counts from baseline at week 48 were compared between treatment regimens with 95% CIs based on stratified normal approximations and observed values.||0.9|-43.3|
71033060|NCT00272779|141575829|SUPERIORITY_OR_OTHER||point estimate|0.761|||||TWO_SIDED|90.0|0.507|1.142|||ANOVA||Point estimates and 90% confidence intervals (CIs) for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||1.142|0.507|
71033061|NCT00272779|141575830|SUPERIORITY_OR_OTHER||point estimate|1.46|||||TWO_SIDED|90.0|1.005|2.121|||ANOVA||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||2.121|1.005|
71033062|NCT00272779|141575831|SUPERIORITY_OR_OTHER||point estimate|0.839|||||TWO_SIDED|90.0|0.612|1.151|||ANOVA||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||1.151|0.612|
71033063|NCT00272779|141575832|SUPERIORITY_OR_OTHER||point estimate|0.282|||||TWO_SIDED|90.0|0.181|0.439|||ANOVA||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||0.439|0.181|
71033064|NCT00272779|141575833|SUPERIORITY_OR_OTHER||point estimate|0.925|||||TWO_SIDED|90.0|0.699|1.223|||ANOVA||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||1.223|0.699|
71154173|NCT03100149|141801024|SUPERIORITY||Difference in Adjusted Means|-0.08|STANDARD_ERROR_OF_MEAN|0.165||0.6116|TWO_SIDED|80.0|-0.3|0.13||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part IA||0.13|-0.30|0.6116
71154174|NCT03100149|141801024|SUPERIORITY||Difference in Adjusted Means|0.08|STANDARD_ERROR_OF_MEAN|0.165||0.6188|TWO_SIDED|80.0|-0.13|0.3||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part IA||0.30|-0.13|0.6188
71154175|NCT03100149|141801024|SUPERIORITY||Difference in Adjusted Means|-0.04|STANDARD_ERROR_OF_MEAN|0.345||0.9062|TWO_SIDED|80.0|-0.48|0.4||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part IB||0.40|-0.48|0.9062
71033065|NCT00272779|141575834|SUPERIORITY_OR_OTHER||point estimate|0.853|||||TWO_SIDED|90.0|0.626|1.161|||ANOVA||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||1.161|0.626|
71033066|NCT00272779|141575835|SUPERIORITY_OR_OTHER||point estimate|0.89|||||TWO_SIDED|90.0|0.689|1.151|||ANOVA||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||1.151|0.689|
71095104|NCT04621760|141698457|SUPERIORITY|||||||0.34||||||a priori threshold for significance: 0.05|Fisher Exact|||Comparing confidence between treatment groups of those who said they intended to use STD testing||||0.34
71154176|NCT03100149|141801024|SUPERIORITY||Difference in Adjusted Means|0.02|STANDARD_ERROR_OF_MEAN|0.347||0.9621|TWO_SIDED|80.0|-0.43|0.46||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part IB||0.46|-0.43|0.9621
71095105|NCT04621760|141698457|SUPERIORITY|||||||0.1||||||a priori threshold for significance: 0.05|Fisher Exact|||Comparing confidence between treatment groups of those who said they intended to use Treatment as Prevention||||0.10
71095106|NCT04621760|141698458|SUPERIORITY|||||||0.01||||||a priori threshold for significance: 0.05|Chi-squared|||||||0.01
71095107|NCT04621760|141698459|SUPERIORITY|||||||0.26||||||a priori threshold for significance: 0.05|Fisher Exact|||"Comparing proportions in response to prompt The information was easy to understand"||||0.26
71095108|NCT04621760|141698459|SUPERIORITY|||||||0.26||||||a priori threshold for significance: 0.05|Fisher Exact|||"Comparing proportions in response to prompt: I got all of the information I needed"||||0.26
71095109|NCT04621760|141698459|SUPERIORITY|||||||0.59||||||a priori threshold for significance: 0.05|Fisher Exact|||||||0.59
71095110|NCT04621760|141698459|SUPERIORITY|||||||0.17||||||a priori threshold for significance: 0.05|Fisher Exact|||"Comparing proportions in response to prompt: The information felt useful to me"||||0.17
71095111|NCT04621760|141698460|SUPERIORITY|||||||0.74|||||||Chi-squared|||"Testing proportion of acceptability of abstinence method (proportion that responded great for me)"||||0.74
71095112|NCT04621760|141698460|SUPERIORITY|||||||0.59|||||||Chi-squared|||"Testing proportion of acceptability of condoms method (proportion that responded great for me)"||||0.59
71095113|NCT04621760|141698460|SUPERIORITY|||||||0.66|||||||Chi-squared|||"Testing proportion of acceptability of PEP method (proportion that responded great for me)"||||0.66
71095114|NCT04621760|141698460|SUPERIORITY|||||||0.49|||||||Chi-squared|||"Testing proportion of acceptability of PrEP method (proportion that responded great for me)"||||0.49
71095115|NCT04621760|141698460|SUPERIORITY|||||||0.94|||||||Chi-squared|||"Testing proportion of acceptability of HIV testing method (proportion that responded great for me)"||||0.94
71095116|NCT04621760|141698460|SUPERIORITY|||||||0.95|||||||Chi-squared|||"Testing proportion of acceptability of STD testing method (proportion that responded great for me)"||||0.95
71095117|NCT04621760|141698460|SUPERIORITY|||||||0.39|||||||Chi-squared|||"Testing proportion of acceptability of Treatment as prevention method (proportion that responded great for me)"||||0.39
71095118|NCT04621760|141698466|SUPERIORITY|||||||0.13||||||a priori threshold for significance: 0.05|Fisher Exact|||||||0.13
71154177|NCT03100149|141801024|SUPERIORITY||Difference in Adjusted Means|-0.19|STANDARD_ERROR_OF_MEAN|0.411||0.651|TWO_SIDED|80.0|-0.71|0.34||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part I Total||0.34|-0.71|0.6510
71095119|NCT04621760|141698467|SUPERIORITY|||||||0.08||||||a priori threshold for significance: 0.05|Fisher Exact|||||||0.08
70921327|NCT04714320|141333622|SUPERIORITY||||||=|0.442||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change From Baseline in 24-hour Mean DBP at Day 85||||=0.442
70921328|NCT04714320|141333623|SUPERIORITY||||||=|0.834||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in the Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 8||||=0.834
70974050|NCT00848354|141455057|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||<0.0001
71095120|NCT04602000|141698472|SUPERIORITY||Difference estimated using CMH weights|-8.0|||<|0.0001|TWO_SIDED|95.0|-11.7|-4.5|||Cochran-Mantel-Haenszel|P-value was calculated using CMH test stratified by age (≥60 vs. \<60 years), baseline comorbidities (Yes vs. No) and region (US vs. EU vs. Other)|The 95% stratified Newcombe CI with CMH weights was presented.|||-4.5|-11.7|<0.0001
71095121|NCT01846871|141698495|OTHER|||||||0.7|||||||t-test, 2 sided|||||||0.70
71095122|NCT01846871|141698496|OTHER|||||||0.028|||||||t-test, 2 sided|||||||0.028
71095123|NCT01846871|141698497|OTHER|||||||0.0019|||||||t-test, 2 sided|||||||0.0019
71095124|NCT01846871|141698498|OTHER|||||||0.033|||||||t-test, 2 sided|||||||0.033
71095125|NCT00471354|141698499|SUPERIORITY_OR_OTHER|||||||0.293||95.0|||||Spearman Partial Rank Order Correlation|||||||0.293
71095126|NCT00471354|141698500|SUPERIORITY_OR_OTHER|||||||0.276||95.0||||P-value for Correlation with Language Scores|Spearman Partial Rank Order Correlation|||||||0.276
71095127|NCT00471354|141698500|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||P-value for Correlation with Math Scores.|Spearman Partial Rank Order Correlation|||||||0.110
71095128|NCT00471354|141698500|SUPERIORITY_OR_OTHER|||||||0.464||95.0||||P-value for Correlation with Science Scores.|Spearman Partial Rank Order Correlation|||||||0.464
71095129|NCT00471354|141698501|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline in Language Scores.|Paired t-test|||||||<0.001
71095130|NCT00471354|141698501|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline in Math Scores.|Paired t-test|||||||<0.001
71095131|NCT00471354|141698501|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline in Science Scores.|Paired t-test|||||||<0.001
71095132|NCT00471354|141698501|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline in Total Scores.|Paired t-test|||||||<0.001
71095133|NCT00471354|141698502|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Paired t-test|||||||<0.001
71095134|NCT00471354|141698503|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Paired t-test|||||||<0.001
71095135|NCT00471354|141698505|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Paired t-test|||||||<0.001
71095136|NCT00923702|141698545|NON_INFERIORITY|To test for non-inferiority of antibody concentrations in different dose groups, log-transformed mean MFIs in linear regression models were used to obtain MFI ratios and their corresponding 95% confidence intervals (CIs). Antibody titres at months 0, 7, 12, 36 and 48 were compared and non-inferiority was inferred when the lower bound of the confidence interval of the ratio of the immunogenicity measures exceeded 0.5.|Risk Ratio (RR)|0.5|||||ONE_SIDED||||||Regression, Linear||The lower bound of the 95% CI ratio of immunogeneicity measures was used instead. No p-values were estimated.|||||
71095137|NCT00923702|141698546|SUPERIORITY||Vaccine efficacy|95.0|||||TWO_SIDED|||||||||||||
71154178|NCT03100149|141801024|SUPERIORITY||Difference in Adjusted Means|0.12|STANDARD_ERROR_OF_MEAN|0.413||0.7709|TWO_SIDED|80.0|-0.41|0.65||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part I Total||0.65|-0.41|0.7709
71095138|NCT01529268|141698581|SUPERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|1.3||||0.34|TWO_SIDED|95.0|0.8|2.1|||Cochran-Mantel-Haenszel|||||2.1|0.8|0.34
71095139|NCT01529268|141698582|SUPERIORITY|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|0.0||||0.9|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||||0.5|-0.6|0.90
70921329|NCT04714320|141333623|SUPERIORITY||||||=|0.945||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in the Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 8||||=0.945
70921330|NCT04714320|141333623|SUPERIORITY||||||=|0.208||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in the Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 15||||=0.208
70921331|NCT04714320|141333623|SUPERIORITY||||||=|0.74||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in the Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 15||||=0.740
70921332|NCT04714320|141333623|SUPERIORITY||||||=|0.019||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in the Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 22||||=0.019
70921333|NCT04714320|141333623|SUPERIORITY||||||=|0.56||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in the Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 22||||=0.560
70921334|NCT04714320|141333623|SUPERIORITY||||||=|0.903||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure are included in Logistic Regression model, firth correction will be applied if quasi-complete separation of data points is detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 29||||=0.903
70921335|NCT04714320|141333623|SUPERIORITY||||||=|0.268||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure are included in Logistic Regression model, firth correction will be applied if quasi-complete separation of data points is detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 29||||=0.268
70921336|NCT04714320|141333623|SUPERIORITY||||||=|0.702||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 36||||=0.702
70974051|NCT00848354|141455057|SUPERIORITY_OR_OTHER|||||||0.0073|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0073
70974052|NCT00848354|141455057|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
70974053|NCT04770779|141455076|SUPERIORITY||Common Risk Difference on Response Rate|17.6||||0.0003|TWO_SIDED|95.0|8.0|27.2|||Mantel Haenszel|||The p-value is based on the Mantel-Haenszel stratum weighted method adjusting for randomization stratification factors.||27.2|8.0|0.0003
70974054|NCT04770779|141455077|SUPERIORITY||Common Risk Difference on Response Rate|11.1||||0.0003|TWO_SIDED|95.0|5.1|17.0|||Mantel Haenszel|||The p-value is based on the Mantel-Haenszel stratum weighted method adjusting for randomization stratification factors.||17.0|5.1|0.0003
70974055|NCT04770779|141455078|SUPERIORITY||Common Risk Difference on Response Rate|13.4|||<|0.0001|TWO_SIDED|95.0|7.7|19.1|||Mantel Haenszel|||The p-value is based on the Mantel-Haenszel stratum weighted method adjusting for randomization stratification factors.||19.1|7.7|<0.0001
70974056|NCT04770779|141455079|SUPERIORITY||Common Risk Difference on Response Rate|6.4||||0.0056|TWO_SIDED|95.0|1.9|10.9|||Mantel Haenszel|||The p-value is based on the Mantel-Haenszel stratum weighted method adjusting for randomization stratification factors.||10.9|1.9|0.0056
70974057|NCT03692052|141455118|OTHER||||||<|0.0001|||||||Clopper-Pearson Method|Significance of p-value associated with the test of H0:Hb response rate =0.3 vs H1:Hb response rate \> 0.3.||||||<.0001
70974058|NCT06232317|141455149|SUPERIORITY|||||||0.61|||||||Kruskal-Wallis|||||||0.61
71095140|NCT01529268|141698583|SUPERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|0.7||||0.15|TWO_SIDED|95.0|0.5|1.1|||Cochran-Mantel-Haenszel|||Steatosis: patients with improvement||1.1|0.5|0.15
70921337|NCT04714320|141333623|SUPERIORITY||||||=|0.885||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 36||||=0.885
70921338|NCT04714320|141333623|SUPERIORITY||||||=|0.066||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 43||||=0.066
70921339|NCT04714320|141333623|SUPERIORITY||||||=|0.783||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 43||||=0.783
70974059|NCT06232317|141455150|SUPERIORITY|||||||0.014|||||||Kruskal-Wallis|||||||0.014
70974060|NCT06232317|141455155|SUPERIORITY|||||||0.011|||||||Fisher Exact|||||||0.011
70974061|NCT05600309|141455156|OTHER||Hazard Ratio (HR)|0.94||||0.3914|TWO_SIDED|95.0|0.59|1.5||One-sided nominal p-value based on log-rank test.|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.50|0.59|0.3914
70974062|NCT05600309|141455157|OTHER||Hazard Ratio (HR)|1.23||||0.8091|TWO_SIDED|95.0|0.78|1.92||One-sided nominal p-value based on log-rank test.|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.92|0.78|0.8091
70974063|NCT05600309|141455158|OTHER||Difference in percentage|6.0||||0.0502|TWO_SIDED|95.0|-2.3|16.3||One-sided nominal p-value for testing.|Miettinen & Nurminen Method||Difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|||16.3|-2.3|0.0502
71033067|NCT00272779|141575859|SUPERIORITY_OR_OTHER|||||||0.0847||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting non-HDL cholesterol (phenotype) and the RETN\_097 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_097 reported in Outcome Measure 16.||||0.0847
71033068|NCT00272779|141575860|SUPERIORITY_OR_OTHER|||||||0.0058||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the RETN\_097 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_097 reported in Outcome Measure 16.||||0.0058
71033069|NCT00272779|141575861|SUPERIORITY_OR_OTHER|||||||0.0058||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the RETN\_2265 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_2265 reported in Outcome Measure 16.||||0.0058
71095141|NCT01529268|141698584|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|0.1||||0.59|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|||Steatosis: change in score||0.4|-0.2|0.59
71095142|NCT01529268|141698585|SUPERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|1.8||||0.03|TWO_SIDED|95.0|1.1|2.9|||Cochran-Mantel-Haenszel|||||2.9|1.1|0.03
70974064|NCT06033079|141455190|SUPERIORITY||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.32|2.95||||||||2.95|0.32|
70974065|NCT06033079|141455191|SUPERIORITY|||||||0.233|||||||Fisher Exact|||||||0.233
70974066|NCT06033079|141455192|SUPERIORITY||Odds Ratio (OR)|0.86|||||TWO_SIDED|95.0|0.3|2.37||||||||2.37|0.30|
70974067|NCT06033079|141455193|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.32|1.82||||||||1.82|0.32|
70974068|NCT06033079|141455194|SUPERIORITY||Odds Ratio (OR)|1.42|||||TWO_SIDED|95.0|0.34|7.51||||||||7.51|0.34|
70974069|NCT06033079|141455195|SUPERIORITY||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.13|1.42||||||||1.42|0.13|
70974070|NCT06033079|141455196|SUPERIORITY||Odds Ratio (OR)|1.72|||||TWO_SIDED|95.0|0.41|7.9||||||||7.90|0.41|
70974071|NCT04770753|141455224|SUPERIORITY||Percentage difference|40.9|||<|0.0001|TWO_SIDED|95.0|32.0|49.8|||Cochran-Mantel-Haenszel|||The estimated adjusted difference in response rate, 95% CI, and p-value are based on Mantel-Haenszel stratum weighted method adjusting for the randomization stratification factors.||49.8|32.0|<0.0001
70974072|NCT04770753|141455225|SUPERIORITY||Difference in Lean Square (LS) Mean|3.4||||0.0026|TWO_SIDED|95.0|1.21|5.59|||ANCOVA|||The estimates, 95% CIs, and 2-sided p-value are based on an analysis of covariance (ANCOVA) model which includes average change from baseline in FACIT-Fatigue subscale score from Week 12 through Week 24 as the dependent variable, treatment group as the independent variable, and baseline and the randomization stratification factors as covariates.||5.59|1.21|0.0026
70974073|NCT04770753|141455226|SUPERIORITY||Difference in LS Mean|9.63|||<|0.0001|TWO_SIDED|95.0|7.8|11.46|||ANCOVA|||The estimates, 95% CIs, and 2-sided p-value are based on an ANCOVA model which includes average change from baseline in Hb concentrations from Week 12 through Week 24 as the dependent variable, treatment group as the independent variable, and baseline Hb concentration and the randomization stratification factors as covariates.||11.46|7.80|<0.0001
70974074|NCT02775851|141455248|SUPERIORITY||||||<|0.001|||||||One-sided Exact Binomial|||We assumed a null pCR rate of 5% and powered the study assuming an alternative hypothesis of 25%. This single stage design had an alpha of 3.4% (i.e. probability of declaring the regimen warrants further study when the true CR is 5%) and a power of 90% (probability of declaring the regimen warrants further study when the true pCR is 25%) with 25 eligible participants.||||<0.001
70974075|NCT02775851|141455249|SUPERIORITY||||||<|0.001|||||||One-sided Exact Binomial|||We assumed a null CR rate of 5% and powered the study assuming an alternative hypothesis of 20%. This single stage design had an alpha of 8.5% (i.e. probability of declaring the regimen warrants further study when the true CR is 5%) and a power of 82% (probability of declaring the regimen warrants further study when the true CR is 20%) with 21 eligible participants.||||<0.001
70974076|NCT06523491|141455259|SUPERIORITY||F value|23.31||||0|TWO_SIDED|||||The threshold for statistical significance was p \<0.05.|ANCOVA|"To compare the efficacy of 1 and 2 NOLTREX courses with placebo was used ANCOVA adjusted for the baseline value with fixed factor of treatment group"||No sample size calculation was performed. In the survey took part 57 patients from the parent study and OLE. The study did not have a formal hypothesis. The between-group comparison of changes from baseline (OLE visit 0) in the WOMAC-T at the end of 12-month follow-up (EOF) visit was conducted using analysis of covariance (ANCOVA) and, as a post hoc test, the Tukey test.||||0.00
70974077|NCT06523491|141455259|SUPERIORITY||LS-means difference|353.18|STANDARD_ERROR_OF_MEAN|72.27||0|TWO_SIDED|95.0|178.91|527.45||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||527.45|178.91|0.00
70974078|NCT06523491|141455259|SUPERIORITY||LS-means difference|-292.19|STANDARD_ERROR_OF_MEAN|78.04||0|TWO_SIDED|95.0|-480.37|-104.01||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||-104.01|-480.37|0.00
70974079|NCT06523491|141455259|SUPERIORITY||LS-means difference|-645.37|STANDARD_ERROR_OF_MEAN|95.68||0|TWO_SIDED|95.0|-876.07|-414.67||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||-414.67|-876.07|0.00
70974080|NCT06523491|141455259|SUPERIORITY||F value|23.31||||0|TWO_SIDED|||||The threshold for statistical significance was p \<0.05.|ANCOVA|"To compare the efficacy of 1 and 2 NOLTREX courses with placebo was used ANCOVA adjusted for the baseline value with fixed factor of treatment group"||The between-group comparison of changes from baseline (study 1 visit 1) in the WOMAC-T at visit 5 was conducted using analysis of covariance (ANCOVA) and, as a post hoc test, the Tukey test.||||0.00
70974081|NCT06523491|141455259|SUPERIORITY||LS-means difference|-292.19|STANDARD_ERROR_OF_MEAN|78.04||0|TWO_SIDED|95.0|-480.37|-104.01|||Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||-104.01|-480.37|0.00
70974082|NCT06523491|141455259|SUPERIORITY||[LS-means difference|-645.37|STANDARD_ERROR_OF_MEAN|95.68||0|TWO_SIDED|95.0|-876.07|-414.67||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||-414.67|-876.07|0.00
70974083|NCT03266016|141455264|SUPERIORITY||Odds Ratio (OR)|1.67||||0.045|TWO_SIDED|95.0|1.01|2.77|||Proportional Odds Logistic Regression|||This analysis is comparing length of weaning between REDvent acute group and control acute group.||2.77|1.01|.045
70974084|NCT03266016|141455264|SUPERIORITY||Proportional odds logistic regression|1.3|||||TWO_SIDED|95.0|0.7|2.6||||||Weaning Phase||2.6|0.7|
70974085|NCT03266016|141455265|SUPERIORITY||Incident rate ratio|1.03|||||TWO_SIDED|95.0|0.84|1.25|||||Negative binomial model.|||1.25|0.84|
70974086|NCT03266016|141455266|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.4|2.7||||||||2.7|0.4|
70974087|NCT03266016|141455267|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.44|2.47||||||||2.47|0.44|
70974088|NCT03266016|141455268|SUPERIORITY||Proportional odds logistic regression|1.6|||||TWO_SIDED|95.0|1.01|2.55||||||||2.55|1.01|
70974089|NCT00805740|141455308|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.8|||||TWO_SIDED|95.0|-12.3|53.3||||||The 95 percent (%) confidence interval (CI) was calculated using method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||53.3|-12.3|
70974090|NCT00805740|141455309|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.6|||||TWO_SIDED|95.0|-13.6|55.6||||||2-week follow-up: The 95% CI was calculated using method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||55.6|-13.6|
70974091|NCT00805740|141455309|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.1|||||TWO_SIDED|95.0|-23.3|47.3||||||6-week follow-up: The 95% CI was calculated using method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||47.3|-23.3|
70974092|NCT00805740|141455311|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-6.1|||||TWO_SIDED|95.0|-39.0|27.9||||||The 95% CI was calculated using method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||27.9|-39.0|
70974093|NCT04669678|141455329|OTHER||Odds Ratio (OR)|0.85||||0.306|TWO_SIDED|90.0|0.65|1.11|||Mixed Models Analysis|||Week 2||1.11|0.65|0.306
70974094|NCT04669678|141455329|OTHER||Odds Ratio (OR)|0.81||||0.874|TWO_SIDED|90.0|0.6|1.09|||Mixed Models Analysis|||Week 4||1.09|0.60|0.874
70974095|NCT04669678|141455329|OTHER||Odds Ratio (OR)|1.04||||0.646|TWO_SIDED|90.0|0.91|1.19|||Mixed Models Analysis|||Week 8||1.19|0.91|0.646
70974096|NCT04669678|141455329|OTHER||Odds Ratio (OR)|1.02||||0.869|TWO_SIDED|90.0|0.82|1.28|||Mixed Models Analysis|||Week 12||1.28|0.82|0.869
70974097|NCT04669678|141455329|OTHER||Odds Ratio (OR)|0.51||||0.044|TWO_SIDED|90.0|0.3|0.88|||Mixed Models Analysis|||Week 2||0.88|0.30|0.044
70974098|NCT04669678|141455329|OTHER||Odds Ratio (OR)|0.36|||<|0.001|TWO_SIDED|90.0|0.28|0.46|||Mixed Models Analysis|||Week 4||0.46|0.28|<0.001
70974099|NCT04669678|141455329|OTHER||Odds Ratio (OR)|0.37|||<|0.001|TWO_SIDED|90.0|0.27|0.49|||Mixed Models Analysis|||Week 8||0.49|0.27|<0.001
70974100|NCT04669678|141455329|OTHER||Odds Ratio (OR)|0.44|||<|0.001|TWO_SIDED|90.0|0.35|0.54|||Mixed Models Analysis|||Week 12||0.54|0.35|<0.001
70974101|NCT04669678|141455330|OTHER||Odds Ratio (OR)|1.25||||0.641|TWO_SIDED|90.0|0.57|2.74|||Mixed Models Analysis|||Week 2||2.74|0.57|0.641
70974102|NCT04669678|141455330|OTHER||Odds Ratio (OR)|1.57||||0.204|TWO_SIDED|90.0|0.87|2.8|||Mixed Models Analysis|||Week 4||2.80|0.87|0.204
71095143|NCT01529268|141698586|SUPERIORITY|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|-0.2||||0.06|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|0.06
70974103|NCT04669678|141455330|OTHER||Odds Ratio (OR)|1.29||||0.415|TWO_SIDED|90.0|0.77|2.15|||Mixed Models Analysis|||Week 8||2.15|0.77|0.415
70974104|NCT04669678|141455330|OTHER||Odds Ratio (OR)|2.23||||0.027|TWO_SIDED|90.0|1.23|4.06|||Mixed Models Analysis|||Week 12||4.06|1.23|0.027
70974105|NCT04669678|141455330|OTHER||Odds Ratio (OR)|1.86||||0.274|TWO_SIDED|90.0|0.73|4.73|||Mixed Models Analysis|||Week 2||4.73|0.73|0.274
71095144|NCT01529268|141698587|SUPERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|0.8||||0.29|TWO_SIDED|95.0|0.4|1.3|||Cochran-Mantel-Haenszel|||||1.3|0.4|0.29
71154179|NCT03100149|141801024|SUPERIORITY||Difference in Adjusted Means|0.34|STANDARD_ERROR_OF_MEAN|0.523||0.5177|TWO_SIDED|80.0|-0.33|1.01||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part II Total||1.01|-0.33|0.5177
70974106|NCT04669678|141455330|OTHER||Odds Ratio (OR)|1.83||||0.065|TWO_SIDED|90.0|1.07|3.13|||Mixed Models Analysis|||Week 4||3.13|1.07|0.065
70974107|NCT04669678|141455330|OTHER||Odds Ratio (OR)|1.72||||0.252|TWO_SIDED|90.0|0.79|3.75|||Mixed Models Analysis|||Week 8||3.75|0.79|0.252
70974108|NCT04669678|141455330|OTHER||Odds Ratio (OR)|2.61||||0.002|TWO_SIDED|90.0|1.57|4.33|||Mixed Models Analysis|||Week 12||4.33|1.57|0.002
70974109|NCT04669678|141455330|OTHER||Odds Ratio (OR)|0.78||||0.46|TWO_SIDED|90.0|0.46|1.34|||Mixed Models Analysis|||Week 20||1.34|0.46|0.460
70974110|NCT04669678|141455330|OTHER||Odds Ratio (OR)|1.59||||0.019|TWO_SIDED|90.0|1.15|2.2|||Mixed Models Analysis|||Week 24||2.20|1.15|0.019
70974111|NCT04669678|141455330|OTHER||Odds Ratio (OR)|2.16||||0.061|TWO_SIDED|90.0|1.1|4.27|||Mixed Models Analysis|||Week 2||4.27|1.10|0.061
71033070|NCT00272779|141575862|SUPERIORITY_OR_OTHER|||||||0.0253||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the RETN\_598 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_598 reported in Outcome Measure 16.||||0.0253
70974112|NCT04669678|141455330|OTHER||Odds Ratio (OR)|1.64||||0.106|TWO_SIDED|90.0|0.99|2.71|||Mixed Models Analysis|||Week 4||2.71|0.99|0.106
71095145|NCT01529268|141698588|SUPERIORITY|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|0.1||||0.15|TWO_SIDED|95.0|-0.1|0.3|||ANCOVA|||||0.3|-0.1|0.15
70974113|NCT04669678|141455330|OTHER||Odds Ratio (OR)|1.77||||0.144|TWO_SIDED|90.0|0.93|3.36|||Mixed Models Analysis|||Week 8||3.36|0.93|0.144
70974114|NCT04669678|141455330|OTHER||Odds Ratio (OR)|2.37||||0.011|TWO_SIDED|90.0|1.36|4.16|||Mixed Models Analysis|||Week 12||4.16|1.36|0.011
70974115|NCT05227690|141455332|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|2.24|=|0.1765|TWO_SIDED|95.0|-7.5|1.4|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Emraclidine 30 mg versus Placebo||1.4|-7.5|=0.1765
70974116|NCT05227690|141455332|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|2.26|=|0.6007|TWO_SIDED|95.0|-5.6|3.3|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Emraclidine 10 mg versus Placebo||3.3|-5.6|=0.6007
70974117|NCT05227690|141455333|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.124|=|0.2534|TWO_SIDED|95.0|-0.39|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Emraclidine 30 mg versus Placebo||0.10|-0.39|=0.2534
70974118|NCT05227690|141455333|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.125|=|0.6774|TWO_SIDED|95.0|-0.3|0.19|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Emraclidine 10 mg versus Placebo||0.19|-0.30|=0.6774
70974119|NCT05227690|141455334|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.1|=|0.3596|TWO_SIDED|95.0|-3.2|1.2|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 1-- Emraclidine 30 mg versus Placebo||1.2|-3.2|=0.3596
71095146|NCT01529268|141698589|SUPERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|1.2||||0.57|TWO_SIDED|95.0|0.6|2.3|||Cochran-Mantel-Haenszel|||||2.3|0.6|0.57
71095147|NCT01529268|141698590|SUPERIORITY|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|0.0||||0.76|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|||||0.2|-0.2|0.76
70921340|NCT04714320|141333623|SUPERIORITY||||||=|0.456||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 50||||=0.456
70921341|NCT04714320|141333623|SUPERIORITY||||||=|0.102||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 50||||=0.102
70921342|NCT04714320|141333623|SUPERIORITY||||||=|0.668||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 57||||=0.668
70921343|NCT04714320|141333623|SUPERIORITY||||||=|0.454||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 57||||=0.454
70921344|NCT04714320|141333623|SUPERIORITY||||||=|0.044||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 64||||=0.044
70921345|NCT04714320|141333623|SUPERIORITY||||||=|0.704||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 64||||=0.704
70921346|NCT04714320|141333623|SUPERIORITY||||||=|0.878||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 71||||=0.878
70921347|NCT04714320|141333623|SUPERIORITY||||||=|0.681||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 71||||=0.681
70921348|NCT04714320|141333623|SUPERIORITY||||||=|0.199||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 78||||=0.199
70921349|NCT04714320|141333623|SUPERIORITY||||||=|0.602||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 78||||=0.602
70921350|NCT04714320|141333623|SUPERIORITY||||||=|0.135||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 85||||=0.135
70921351|NCT04714320|141333623|SUPERIORITY||||||=|0.407||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 85||||=0.407
70921352|NCT04714320|141333623|SUPERIORITY||||||=|0.795||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 92||||=0.795
70921353|NCT04714320|141333623|SUPERIORITY||||||=|0.036||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 92||||=0.036
70921354|NCT04714320|141333623|SUPERIORITY||||||=|0.915||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 106||||=0.915
70921355|NCT04714320|141333623|SUPERIORITY||||||=|0.957||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 106||||=0.957
71008741|NCT02055976|141525249|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.649|STANDARD_ERROR_OF_MEAN|10.933||0.303|TWO_SIDED|95.0|-27.376|16.079|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||16.079|-27.376|0.303
70921356|NCT04714320|141333623|SUPERIORITY||||||=|0.804||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 120||||=0.804
70921357|NCT04714320|141333623|SUPERIORITY||||||=|0.775||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 120||||=0.775
70921358|NCT04714320|141333623|SUPERIORITY||||||=|0.801||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 148||||=0.801
70921359|NCT04714320|141333623|SUPERIORITY||||||=|0.329||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 148||||=0.329
70921360|NCT04714320|141333623|SUPERIORITY||||||=|0.882||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 169||||=0.882
70921361|NCT04714320|141333623|SUPERIORITY||||||=|0.235||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 169||||=0.235
70921362|NCT04714320|141333623|SUPERIORITY||||||=|0.505||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 8||||=0.505
70921363|NCT04714320|141333623|SUPERIORITY||||||=|0.436||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 8||||=0.436
70974120|NCT05227690|141455334|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|1.1|=|0.6053|TWO_SIDED|95.0|-2.7|1.6|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 1-- Emraclidine 10 mg versus Placebo||1.6|-2.7|=0.6053
70974121|NCT05227690|141455334|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.54|=|0.8149|TWO_SIDED|95.0|-3.4|2.7|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 2-- Emraclidine 30 mg versus Placebo||2.7|-3.4|=0.8149
70974122|NCT05227690|141455334|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.55|=|0.9058|TWO_SIDED|95.0|-3.2|2.9|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 2-- Emraclidine 10 mg versus Placebo||2.9|-3.2|=0.9058
70974123|NCT05227690|141455334|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.71|=|0.5419|TWO_SIDED|95.0|-4.4|2.3|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 3-- Emraclidine 30 mg versus Placebo||2.3|-4.4|=0.5419
70974124|NCT05227690|141455334|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.72|=|0.8585|TWO_SIDED|95.0|-3.1|3.7|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 3-- Emraclidine 10 mg versus Placebo||3.7|-3.1|=0.8585
70974125|NCT05227690|141455334|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|1.99|=|0.5521|TWO_SIDED|95.0|-5.1|2.7|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 4-- Emraclidine 30 mg versus Placebo||2.7|-5.1|=0.5521
70921364|NCT04714320|141333623|SUPERIORITY||||||=|0.637||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 15||||=0.637
70921365|NCT04714320|141333623|SUPERIORITY||||||=|0.254||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 15||||=0.254
70921366|NCT04714320|141333623|SUPERIORITY||||||=|0.848||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 22||||=0.848
71095148|NCT01529268|141698591|SUPERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|1.0||||0.98|TWO_SIDED|95.0|0.6|1.6|||Cochran-Mantel-Haenszel|||||1.6|0.6|0.98
71095149|NCT01529268|141698592|SUPERIORITY|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|-0.2||||0.24|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.24
71095150|NCT01529268|141698593|NON_INFERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|2.7||||0.29|TWO_SIDED|95.0|0.4|18.3|||Cochran-Mantel-Haenszel|Stratified by clinic and weight group||||18.3|0.4|0.29
70921367|NCT04714320|141333623|SUPERIORITY||||||=|0.24||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 22||||=0.240
70921368|NCT04714320|141333623|SUPERIORITY||||||=|0.382||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 29||||=0.382
70921369|NCT04714320|141333623|SUPERIORITY||||||=|0.935||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 29||||=0.935
70921370|NCT04714320|141333623|SUPERIORITY||||||=|0.278||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 36||||=0.278
70921371|NCT04714320|141333623|SUPERIORITY||||||=|0.211||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 36||||=0.211
70921372|NCT04714320|141333623|SUPERIORITY||||||=|0.562||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 43||||=0.562
70921373|NCT04714320|141333623|SUPERIORITY||||||=|0.25||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 43||||=0.250
70921374|NCT04714320|141333623|SUPERIORITY||||||=|0.114||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 50||||=0.114
70921375|NCT04714320|141333623|SUPERIORITY||||||=|0.55||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 50||||=0.550
70921376|NCT04714320|141333623|SUPERIORITY||||||=|0.423||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 57||||=0.423
70921377|NCT04714320|141333623|SUPERIORITY||||||=|0.422||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 57||||=0.422
70974126|NCT05227690|141455334|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|2.0|=|0.754|TWO_SIDED|95.0|-4.6|3.3|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 4-- Emraclidine 10 mg versus Placebo||3.3|-4.6|=0.7540
70974127|NCT05227690|141455334|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|2.12|=|0.4842|TWO_SIDED|95.0|-5.7|2.7|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 5-- Emraclidine 30 mg versus Placebo||2.7|-5.7|=0.4842
70974128|NCT05227690|141455334|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|2.13|=|0.6999|TWO_SIDED|95.0|-5.0|3.4|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 5-- Emraclidine 10 mg versus Placebo||3.4|-5.0|=0.6999
71154180|NCT03100149|141801024|SUPERIORITY||Difference in Adjusted Means|-0.06|STANDARD_ERROR_OF_MEAN|0.523||0.9095|TWO_SIDED|80.0|-0.73|0.61||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part II Total||0.61|-0.73|0.9095
71033071|NCT00272779|141575863|SUPERIORITY_OR_OTHER|||||||0.1173||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the APOE\_C130R genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with APOE\_C130R reported in Outcome Measure 16.||||0.1173
71033072|NCT00272779|141575864|SUPERIORITY_OR_OTHER|||||||0.1173||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the RETN\_734 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_734 reported in Outcome Measure 16.||||0.1173
71033073|NCT00272779|141575865|SUPERIORITY_OR_OTHER|||||||0.1847||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting PAI-1 (phenotype) and the APOE\_R176C genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with APOE\_R176C reported in Outcome Measure 16.||||0.1847
71033074|NCT00272779|141575866|SUPERIORITY_OR_OTHER|||||||0.1833||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis:There is no association between the mean change from baseline in fasting Tumor Necrosis Factor(TNF)-alpha (phenotype) and the IL6\_5309 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, wk48 and 96) to test the overall genotype effect (ie. an omnibus test on both marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with IL6\_5309 reported in Outcome Measure 16||||0.1833
71033075|NCT00272779|141575867|SUPERIORITY_OR_OTHER|||||||0.1833||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting TNF-alpha (phenotype) and the RS11030679 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_097 reported in Outcome Measure 16.||||0.1833
71095151|NCT01529268|141698594|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing change from baseline to 52 weeks in serum alanine aminotransferase on treatment group and baseline value of serum alanine aminotransferase.|Adjusted difference in mean changes|-24.0||||0.02|TWO_SIDED|95.0|-44.0|-4.0|||ANCOVA|Adjusted for baseline serum alanine aminotransferase||Adjusted difference in mean changes in serum alanine aminotransferase (ALT). The change in ALT is adjusted for the baseline ALT value; therefore, the adjusted difference in mean changes is not equal to the net change.||-4|-44|0.02
71095152|NCT01529268|141698594|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in serum aspartate aminotransferase on treatment group and baseline value of serum aspartate aminotransferase.|Mean Difference (Net)|-15.0||||0.008|TWO_SIDED|95.0|-26.0|-4.0|||ANCOVA|Adjusted for baseline serum aspartate aminotransferase.||Adjusted difference in mean changes in serum aspartate aminotransferase (AST). The change in AST is adjusted for the baseline AST value; therefore, the adjusted difference in mean changes is not equal to the net change.||-4|-26|0.008
71095153|NCT01529268|141698594|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in gamma-glutamyl transpeptidase on treatment group and baseline value of gamma-glutamyl transpeptidase.|Mean Difference (Net)|-7.0||||0.02|TWO_SIDED|95.0|-13.0|-1.0|||ANCOVA|Adjusted for baseline gamma-glutamyl transpeptidase||Adjusted difference in mean changes in serum gamma-glutamyl transpeptidase (GGT). The change in GGT is adjusted for the baseline GGTvalue; therefore, the adjusted difference in mean changes is not equal to the net change.||-1|-13|0.02
71154181|NCT03100149|141801024|SUPERIORITY||Difference in Adjusted Means|-1.88|STANDARD_ERROR_OF_MEAN|1.255||0.1354|TWO_SIDED|80.0|-3.49|-0.27||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Total||-0.27|-3.49|0.1354
70921378|NCT04714320|141333623|SUPERIORITY||||||=|0.073||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 64||||=0.073
70974129|NCT05227690|141455334|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|2.24|=|0.1765|TWO_SIDED|95.0|-7.5|1.4|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 6-- Emraclidine 30 mg versus Placebo||1.4|-7.5|=0.1765
70974130|NCT05227690|141455334|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|2.26|=|0.6007|TWO_SIDED|95.0|-5.6|3.3|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 6-- Emraclidine 10 mg versus Placebo||3.3|-5.6|=0.6007
70974131|NCT05227690|141455335|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.061|=|0.5822|TWO_SIDED|95.0|-0.15|0.09|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 1-- Emraclidine 30 mg versus Placebo||0.09|-0.15|=0.5822
70921379|NCT04714320|141333623|SUPERIORITY||||||=|0.278||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 64||||=0.278
70921380|NCT04714320|141333623|SUPERIORITY||||||=|0.338||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 71||||=0.338
70921381|NCT04714320|141333623|SUPERIORITY||||||=|0.969||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 71||||=0.969
70921382|NCT04714320|141333623|SUPERIORITY||||||=|0.489||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 78||||=0.489
70921383|NCT04714320|141333623|SUPERIORITY||||||=|0.156||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 78||||=0.156
70921384|NCT04714320|141333623|SUPERIORITY||||||=|0.389||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 85||||=0.389
70921385|NCT04714320|141333623|SUPERIORITY||||||=|0.775||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 85||||=0.775
70921386|NCT04714320|141333623|SUPERIORITY||||||=|0.437||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 92||||=0.437
70921387|NCT04714320|141333623|SUPERIORITY||||||=|0.618|||||||Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 92||||=0.618
70921388|NCT04714320|141333623|SUPERIORITY||||||=|0.079||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 106||||=0.079
70921389|NCT04714320|141333623|SUPERIORITY||||||=|0.349||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 106||||=0.349
70921390|NCT04714320|141333623|SUPERIORITY||||||=|0.58||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 120||||=0.580
70921391|NCT04714320|141333623|SUPERIORITY||||||=|0.106||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 120||||=0.106
70921392|NCT04714320|141333623|SUPERIORITY||||||=|0.955||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 148||||=0.955
70921393|NCT04714320|141333623|SUPERIORITY||||||=|0.134||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 148||||=0.134
70921394|NCT04714320|141333623|SUPERIORITY||||||=|0.933||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 169||||=0.933
70921395|NCT04714320|141333623|SUPERIORITY||||||=|0.502||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 169||||=0.502
70921396|NCT04714320|141333623|SUPERIORITY||||||=|0.653||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 8||||=0.653
70921397|NCT04714320|141333623|SUPERIORITY||||||=|0.816||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 8||||=0.816
70921398|NCT04714320|141333623|SUPERIORITY||||||=|0.184||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 15||||=0.184
70921399|NCT04714320|141333623|SUPERIORITY||||||=|0.765||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 15||||=0.765
70921400|NCT04714320|141333623|SUPERIORITY||||||=|0.009||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 22||||=0.009
70921401|NCT04714320|141333623|SUPERIORITY||||||=|0.578||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 22||||=0.578
70921402|NCT04714320|141333623|SUPERIORITY||||||=|0.725||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 29||||=0.725
70921403|NCT04714320|141333623|SUPERIORITY||||||=|0.287||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 29||||=0.287
70921404|NCT04714320|141333623|SUPERIORITY||||||=|0.705||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 36||||=0.705
70921405|NCT04714320|141333623|SUPERIORITY||||||=|0.975||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 36||||=0.975
70921406|NCT04714320|141333623|SUPERIORITY||||||=|0.118||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 43||||=0.118
70921407|NCT04714320|141333623|SUPERIORITY||||||=|0.959||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 43||||=0.959
70921408|NCT04714320|141333623|SUPERIORITY||||||=|0.413||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 50||||=0.413
70921409|NCT04714320|141333623|SUPERIORITY||||||=|0.043||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 50||||=0.043
70921410|NCT04714320|141333623|SUPERIORITY||||||=|0.849||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 57||||=0.849
70921411|NCT04714320|141333623|SUPERIORITY||||||=|0.662||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 57||||=0.662
71154182|NCT03100149|141801024|SUPERIORITY||Difference in Adjusted Means|-1.02|STANDARD_ERROR_OF_MEAN|1.262||0.4217|TWO_SIDED|80.0|-2.64|0.61||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Total||0.61|-2.64|0.4217
70921412|NCT04714320|141333623|SUPERIORITY||||||=|0.047||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 64||||=0.047
71033076|NCT00272779|141575868|SUPERIORITY_OR_OTHER|||||||0.1694||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in SAT-to-TAT Ratio (phenotype) and the CCDC122\_5980 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with CCDC122\_5980 reported in Outcome Measure 16.||||0.1694
71033077|NCT00272779|141575869|SUPERIORITY_OR_OTHER|||||||0.1335||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in VAT (phenotype) and the BRUNOL\_1842 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with BRUNOL\_1842 reported in Outcome Measure 16.||||0.1335
71033078|NCT00272779|141575870|SUPERIORITY_OR_OTHER|||||||0.1335||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in VAT (phenotype) and the RETN\_730 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_730 reported in Outcome Measure 16.||||0.1335
71033079|NCT00272779|141575871|SUPERIORITY_OR_OTHER|||||||0.1696||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in VAT-to-TAT Ratio (phenotype) and the CCDA122\_5980 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with CCDA122\_5980 reported in Outcome Measure 16.||||0.1696
71033080|NCT02440711|141575897|SUPERIORITY|||||||0.18||||||A significance threshold for all analyses was set at α=0.05. Bonferroni corrections for multiple comparisons were applied.|Multivariate regression|The multivariate regression included participants' biological masses and walking speeds as covariates.||Analysis of VO2 at slow walking speed||||.18
71033081|NCT02440711|141575897|SUPERIORITY|||||||0.21||||||A significance threshold for all analyses was set at α=0.05. Bonferroni corrections for multiple comparisons were applied.|Multivariate regression|The multivariate regression included participants' biological masses and walking speeds as covariates.||Analysis of VO2 at comfortable walking speed||||.21
71033082|NCT02440711|141575897|SUPERIORITY|||||||0.16||||||A significance threshold for all analyses was set at α=0.05. Bonferroni corrections for multiple comparisons were applied.|Multivariate regression|The multivariate regression included participants' biological masses and walking speeds as covariates.||Analysis of VO2 at fast walking speed||||.16
70921413|NCT04714320|141333623|SUPERIORITY||||||=|0.95||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 64||||=0.950
70921414|NCT04714320|141333623|SUPERIORITY||||||=|0.656||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 71||||=0.656
71033083|NCT02440711|141575899|SUPERIORITY|||||||0.29||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||.29
71033084|NCT02440711|141575901|SUPERIORITY|||||||0.05||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||0.05
71095154|NCT01529268|141698595|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|P-value and adjusted difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in weight (kg) on treatment group and baseline weight (kg).|Adjusted difference in mean changes|-1.5||||0.25|TWO_SIDED|95.0|-4.1|1.1|||ANCOVA|Adjusted for baseline weight (kg).||Adjusted difference in mean changes in weight (kg). The change in weight is adjusted for the baseline weight value; therefore, the adjusted difference in mean changes is not equal to the net change.||1.1|-4.1|0.25
71154183|NCT03100149|141801024|SUPERIORITY||Difference in Adjusted Means|0.09|STANDARD_ERROR_OF_MEAN|0.369||0.8053|TWO_SIDED|80.0|-0.38|0.56||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Rigidity||0.56|-0.38|0.8053
71033085|NCT02440711|141575903|SUPERIORITY|||||||0.25||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||.25
71095155|NCT01529268|141698596|SUPERIORITY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks on treatment group and baseline value of the outcome.|Adjusted difference in mean changes|-0.3||||0.42|TWO_SIDED|95.0|-1.1|0.5|||ANCOVA|Adjusted for baseline BMI (kg/m2)||Adjusted difference in mean changes in body mass index (BMI). The change in BMI is adjusted for the baseline BMI value; therefore, the adjusted difference in mean changes is not equal to the net change.||0.5|-1.1|0.42
71095156|NCT01529268|141698597|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks on treatment group and baseline value of the outcome.|Mean Difference (Net)|-0.1||||0.11|TWO_SIDED|95.0|-0.1|0.0|||ANCOVA|||||0.0|-0.1|0.11
71095157|NCT01529268|141698598|SUPERIORITY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in waist circumference on treatment group and baseline value of waist circumference.|Adjusted difference in mean changes|0.2||||0.89|TWO_SIDED|95.0|-2.3|2.6|||ANCOVA|Adjusted for baseline waist circumference (cm)||Adjusted difference in mean changes in waist circumference (cm). The change in waist circumference is adjusted for the baseline waist circumference value; therefore, the adjusted difference in mean changes is not equal to the net change.||2.6|-2.3|0.89
70921415|NCT04714320|141333623|SUPERIORITY||||||=|0.922||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 71||||=0.922
70921416|NCT04714320|141333623|SUPERIORITY||||||=|0.143||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 78||||=0.143
70921417|NCT04714320|141333623|SUPERIORITY||||||=|0.452||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 78||||=0.452
70921418|NCT04714320|141333623|SUPERIORITY||||||=|0.231||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 85||||=0.231
70921419|NCT04714320|141333623|SUPERIORITY||||||=|0.405||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 85||||=0.405
70921420|NCT04714320|141333623|SUPERIORITY||||||=|0.718||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 92||||=0.718
70921421|NCT04714320|141333623|SUPERIORITY||||||=|0.053||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 92||||=0.053
70921422|NCT04714320|141333623|SUPERIORITY||||||=|0.893||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 106||||=0.893
70921423|NCT04714320|141333623|SUPERIORITY||||||=|0.662||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 106||||=0.662
70921424|NCT04714320|141333623|SUPERIORITY||||||=|0.688||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 120||||=0.688
70921425|NCT04714320|141333623|SUPERIORITY||||||=|0.611||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 120||||=0.611
71033086|NCT02440711|141575905|SUPERIORITY|||||||0.86||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||.86
71033087|NCT02440711|141575907|SUPERIORITY|||||||0.14||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||Prosthetic side step length results||||.14
71033088|NCT02440711|141575907|SUPERIORITY||||||<|0.001||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||Sound side step length results||||<0.001
71033089|NCT02440711|141575909|SUPERIORITY|||||||0.61||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||Prosthetic side step time results||||.61
71033090|NCT02440711|141575909|SUPERIORITY|||||||0.4||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||Sound side step time results||||.40
71033091|NCT02440711|141575911|SUPERIORITY|||||||0.14||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||.14
71033092|NCT02440711|141575913|SUPERIORITY|||||||0.001||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||0.001
70921426|NCT04714320|141333623|SUPERIORITY||||||=|0.907||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 148||||=0.907
70921427|NCT04714320|141333623|SUPERIORITY||||||=|0.699||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 148||||=0.699
70921428|NCT04714320|141333623|SUPERIORITY||||||=|0.802||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 169||||=0.802
70921429|NCT04714320|141333623|SUPERIORITY||||||=|0.206||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 169||||=0.206
70921430|NCT04714320|141333624|SUPERIORITY||||||=|0.28||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 8||||=0.280
70921431|NCT04714320|141333624|SUPERIORITY||||||=|0.648||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 8||||=0.648
70921432|NCT04714320|141333624|SUPERIORITY||||||=|0.416||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 15||||=0.416
71033093|NCT02440711|141575915|SUPERIORITY|||||||0.001||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||0.001
71033094|NCT02440711|141575917|SUPERIORITY|||||||0.005||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||0.005
70921433|NCT04714320|141333624|SUPERIORITY||||||=|0.9||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 15||||=0.900
70921434|NCT04714320|141333624|SUPERIORITY||||||=|0.627||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 22||||=0.627
70921435|NCT04714320|141333624|SUPERIORITY||||||=|0.921||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 22||||=0.921
71033095|NCT02440711|141575919|SUPERIORITY|||||||0.002||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||TAPES-AR results||||0.002
71033096|NCT02440711|141575919|SUPERIORITY||||||<|0.001||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||TAPES-FUN results||||<0.001
71033097|NCT02440711|141575919|SUPERIORITY|||||||0.85||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||TAPES-AES results||||0.85
71033098|NCT01980771|141575921|SUPERIORITY||Odds Ratio (OR)|1.58||||0.04|TWO_SIDED|95.0|1.03|2.43|||Mixed Models Analysis|||||2.43|1.03|0.04
71033099|NCT02718326|141575946|SUPERIORITY||percentage difference|52.3|||<|0.0001|TWO_SIDED|95.0|45.2|59.5|||Cochran-Mantel-Haenszel|||||59.5|45.2|<0.0001
71033100|NCT02718326|141575947|SUPERIORITY||percentage difference|50.1|||<|0.0001|TWO_SIDED|95.0|40.1|60.1|||Cochran-Mantel-Haenszel|||||60.1|40.1|<0.0001
71033101|NCT02718326|141575947|SUPERIORITY||percentage difference|64.8|||<|0.0001|TWO_SIDED|95.0|55.8|73.9|||Cochran-Mantel-Haenszel|||||73.9|55.8|< 0.0001
71033102|NCT02718326|141575948|SUPERIORITY||percentage difference|-17.3|||<|0.0001|TWO_SIDED|95.0|-24.7|-9.9|||Cochran-Mantel-Haenszel|||||-9.9|-24.7|<0.0001
71033103|NCT02718326|141575948|SUPERIORITY||percentage difference|-16.6|||<|0.0001|TWO_SIDED|95.0|-24.2|-9.1|||Cochran-Mantel-Haenszel|||||-9.1|-24.2|<0.0001
71033104|NCT02718326|141575949|SUPERIORITY||percentage difference|-17.3|||=|0.0002|TWO_SIDED|95.0|-26.2|-8.5|||Cochran-Mantel-Haenszel|||||-8.5|-26.2|= 0.0002
71033105|NCT02718326|141575949|SUPERIORITY||percentage difference|-18.9|||<|0.0001|TWO_SIDED|95.0|-27.5|-10.4|||Cochran-Mantel-Haenszel|||||-10.4|-27.5|<0.0001
71033106|NCT02718326|141575952|SUPERIORITY||percentage difference|-6.0||||0.0096|TWO_SIDED|95.0|-10.5|-1.5|||Cochran-Mantel-Haenszel|||||-1.5|-10.5|0.0096
70974132|NCT05227690|141455335|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.061|=|0.9244|TWO_SIDED|95.0|-0.11|0.13|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 1-- Emraclidine 10 mg versus Placebo||0.13|-0.11|=0.9244
70974133|NCT05227690|141455335|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.088|=|0.9348|TWO_SIDED|95.0|-0.17|0.18|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 2-- Emraclidine 30 mg versus Placebo||0.18|-0.17|=0.9348
70974134|NCT05227690|141455335|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.089|=|0.716|TWO_SIDED|95.0|-0.21|0.14|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 2-- Emraclidine 10 mg versus Placebo||0.14|-0.21|=0.7160
71033107|NCT02718326|141575952|SUPERIORITY||percentage difference|-6.0||||0.0089|TWO_SIDED|95.0|-10.5|-1.6|||Cochran-Mantel-Haenszel|||||-1.6|-10.5|0.0089
71033108|NCT02718326|141575953|SUPERIORITY||Estimate for contrast|0.8||||0.0529|TWO_SIDED|95.0|-0.01|1.6|||ANOVA|||||1.60|-0.01|0.0529
71033109|NCT02718326|141575953|SUPERIORITY||Estimate for contrast|1.14||||0.0057|TWO_SIDED|95.0|0.33|1.94|||ANOVA|||||1.94|0.33|0.0057
71033110|NCT00573443|141576006|SUPERIORITY_OR_OTHER||Ratio of episode-rate reduction ratios|0.5312|||<|0.0001|TWO_SIDED|95.0|0.4939|0.5714|||Regression, Longitudinal neg. binomial|||Analysis of PBA episode rates used longitudinal negative binomial regression with treatment, period, diagnosis and study site to estimate pre-post changes in log mean episode rate for each treatment group. Null hypothesis of equal pre-post episode rate reductions were tested: AVP-923-30/placebo = 1.||0.5714|0.4939|<0.0001
71095158|NCT01529268|141698599|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in fasting serum glucose on treatment group and baseline fasting serum glucose value.|Adjusted difference in mean changes|-4.0||||0.24|TWO_SIDED|95.0|-11.0|3.0|||ANCOVA|Adjusted for baseline serum glucose value.||Adjusted difference in mean changes in fasting serum glucose. The change in fasting serum glucose is adjusted for the baseline fasting serum glucose value; therefore, the adjusted difference in mean changes is not equal to the net change.||3|-11|0.24
71095159|NCT01529268|141698600|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in fasting insulin on treatment group and baseline fasting insulin.|Adjusted difference in mean changes|-6.0||||0.34|TWO_SIDED|95.0|-18.0|6.0|||ANCOVA|Adjusted for baseline fasting insulin.||Adjusted difference in mean changes in fasting insulin. The change in fasting insulin is adjusted for the baseline fasting insulin value; therefore, the adjusted difference in mean changes is not equal to the net change.||6|-18|0.34
70974135|NCT05227690|141455335|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.1|=|0.6883|TWO_SIDED|95.0|-0.24|0.16|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 3-- Emraclidine 30 mg versus Placebo||0.16|-0.24|=0.6883
71033111|NCT00573443|141576006|SUPERIORITY_OR_OTHER||Ratio of episode-rate reduction ratios|0.5103|||<|0.0001|TWO_SIDED|95.0|0.4755|0.5477|||Regression, Longitudinal neg. binomial|||Analysis of PBA episode rates used longitudinal negative binomial regression with treatment, period, diagnosis and study site to estimate pre-post changes in log mean episode rate for each treatment group. Null hypothesis of equal pre-post episode rate reductions were tested: AVP-923-20/placebo = 1.||0.5477|0.4755|<0.0001
71033112|NCT00804856|141576014|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.91||||0.0523|TWO_SIDED|95.0|0.99|8.58|||Regression, Logistic||Ratio calculated as Phase II Schedule A Volasertib 350mg+LDAC divided by Phase II Schedule C LDAC.|Analysis for Objective Response||8.58|0.99|0.0523
71033113|NCT00804856|141576018|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57||||0.0208|TWO_SIDED|95.0|0.35|0.92|||Log Rank||Ratio calculated as Phase II Schedule A Volasertib 350mg+LDAC divided by Phase II Schedule C LDAC.|An exploratory (non-stratified) logrank test was used to compare the different treatment arms.||0.92|0.35|0.0208
71033114|NCT00804856|141576019|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.0465|TWO_SIDED|95.0|0.4|1.0|||Log Rank||Ratio calculated as Phase II Schedule A Volasertib 350mg+LDAC divided by Phase II Schedule C LDAC.|An exploratory (non-stratified) logrank test was used to compare the different treatment arms.||1.00|0.40|0.0465
71033115|NCT00418561|141576036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0737|TWO_SIDED|||||Test for no difference between cohorts.|ANOVA|||The comparisons of the three doses were done using analysis of variance (ANOVA) model including the baseline measurement as a covariate.||||0.0737
71033116|NCT00418561|141576037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1115|TWO_SIDED|||||Test for no difference between cohorts.|ANOVA|||The comparisons of the three doses were done using ANOVA model including the baseline measurement as a covariate.||||0.1115
71033117|NCT00418561|141576039|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1268|TWO_SIDED|||||Test for no difference between cohorts.|ANOVA|||The comparisons of the three doses were done using ANOVA model including the baseline measurement as a covariate.||||0.1268
71033118|NCT00829309|141576065|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.45||||||90.0|80.08|121.03|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||121.03|80.08|
71033119|NCT00829309|141576066|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|90.98||||||90.0|85.23|97.12|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||97.12|85.23|
71154184|NCT03100149|141801024|SUPERIORITY||Difference in Adjusted Means|0.25|STANDARD_ERROR_OF_MEAN|0.37||0.497|TWO_SIDED|80.0|-0.22|0.73||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Rigidity||0.73|-0.22|0.4970
71154185|NCT03100149|141801024|SUPERIORITY||Difference in Adjusted Means|-1.07|STANDARD_ERROR_OF_MEAN|0.779||0.1703|TWO_SIDED|80.0|-2.07|-0.07||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Bradykinesia||-0.07|-2.07|0.1703
70974136|NCT05227690|141455335|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.1|=|0.5973|TWO_SIDED|95.0|-0.14|0.25|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 3-- Emraclidine 10 mg versus Placebo||0.25|-0.14|=0.5973
70974137|NCT05227690|141455335|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.11|=|0.1392|TWO_SIDED|95.0|-0.38|0.05|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 4-- Emraclidine 30 mg versus Placebo||0.05|-0.38|=0.1392
70974138|NCT05227690|141455335|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.111|=|0.9421|TWO_SIDED|95.0|-0.21|0.23|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 4-- Emraclidine 10 mg versus Placebo||0.23|-0.21|=0.9421
70974139|NCT05227690|141455335|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.116|=|0.5431|TWO_SIDED|95.0|-0.3|0.16|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 5-- Emraclidine 30 mg versus Placebo||0.16|-0.30|=0.5431
70974140|NCT05227690|141455335|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.117|=|0.816|TWO_SIDED|95.0|-0.2|0.26|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 5-- Emraclidine 10 mg versus Placebo||0.26|-0.20|=0.8160
70974141|NCT05227690|141455335|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.124|=|0.2534|TWO_SIDED|95.0|-0.39|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 6-- Emraclidine 30 mg versus Placebo||0.10|-0.39|=0.2534
70974142|NCT05227690|141455335|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.125|=|0.6774|TWO_SIDED|95.0|-0.3|0.19|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 6-- Emraclidine 10 mg versus Placebo||0.19|-0.30|=0.6774
71033120|NCT00829309|141576067|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|96.3||||||90.0|85.34|108.66|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||108.66|85.34|
71033121|NCT02322593|141576068|SUPERIORITY||Hazard Ratio (HR)|0.83|STANDARD_ERROR_OF_MEAN|0.091||0.039|TWO_SIDED|95.0|0.69|0.99|||Log Rank|||||0.99|0.69|0.039
71033122|NCT02322593|141576069|SUPERIORITY||Hazard Ratio (HR)|0.79|STANDARD_ERROR_OF_MEAN|0.086||0.0045|TWO_SIDED|95.0|0.66|0.93|||Log Rank|||||0.93|0.66|0.0045
71033123|NCT02322593|141576070|SUPERIORITY||Hazard Ratio (HR)|0.82|STANDARD_ERROR_OF_MEAN|0.078||0.011|TWO_SIDED|95.0|0.7|0.96|||Log Rank|||||0.96|0.70|0.011
71033124|NCT02322593|141576071|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71033125|NCT02322593|141576072|SUPERIORITY|||||||0.092|||||||Fisher Exact|||||||0.092
71033126|NCT02659150|141576096|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_DEVIATION|0.24||0.26|TWO_SIDED||||||t-test, 2 sided|||Paired T-test comparing values obtained during the follow-up imaging (at 13-18 weeks)minus the baseline values||||0.26
71033127|NCT02659150|141576097|OTHER||Spearman Correlation Coefficient|0.76||||0.036|TWO_SIDED||||||Spearman|||correlation coefficient||||0.036
71033128|NCT02659150|141576098|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_DEVIATION|0.32||0.14|TWO_SIDED||||||t-test, 2 sided|||The carotid artery plaque with highest FDG uptake is located using Positron Emission Tomography/ Magnetic Resonance Imaging images. Thereafter Paired T- Test is used to compare baseline vs follow-up values of FDG uptake (before vs after 12 weeks of tocilizumab treatment). FDG uptake is assessed as a Target to background values (TBR) , which is calculated as the mean arterial standardized uptake value (SUV) divided by background blood pool SUV.||||0.14
71033129|NCT02659150|141576099|SUPERIORITY||correlation coefficient|-0.66||||0.076|TWO_SIDED||||||Spearman's Method|||||||0.076
71033130|NCT02659150|141576100|SUPERIORITY||Correlation coefficient|0.67||||0.07|TWO_SIDED||||||Spearman's Method|||||||0.07
71154186|NCT03100149|141801024|SUPERIORITY||Difference in Adjusted Means|-0.44|STANDARD_ERROR_OF_MEAN|0.782||0.5729|TWO_SIDED|80.0|-1.45|0.56||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Bradykinesia||0.56|-1.45|0.5729
70974143|NCT05227690|141455336|SUPERIORITY|Odds ratio, 95% confidence interval, and p-value were from a logistic regression with treatment group, geographic region and Baseline value as a covariate.|Odds Ratio|1.9|||=|0.0904|TWO_SIDED|95.0|0.9|3.99|||Regression, Logistic|||Emraclidine 30 mg versus Placebo||3.99|0.90|=0.0904
70974144|NCT05227690|141455336|SUPERIORITY|Odds ratio, 95% confidence interval, and p-value were from a logistic regression with treatment group, geographic region and Baseline value as a covariate.|Odds Ratio|1.96|||=|0.0756|TWO_SIDED|95.0|0.93|4.13|||Regression, Logistic|||Emraclidine 10 mg versus Placebo||4.13|0.93|=0.0756
70974145|NCT05227690|141455343|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.05|=|0.2418|TWO_SIDED|95.0|0.0|0.2|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 3-- Emraclidine 30 mg versus Placebo||0.2|0.0|=0.2418
70974146|NCT05227690|141455343|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05|=|0.572|TWO_SIDED|95.0|-0.1|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 3-- Emraclidine 10 mg versus Placebo||0.1|-0.1|=0.5720
70974147|NCT05227690|141455343|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06|=|0.7459|TWO_SIDED|95.0|-0.1|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 6-- Emraclidine 30 mg versus Placebo||0.1|-0.1|=0.7459
70974148|NCT05227690|141455343|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06|=|0.6729|TWO_SIDED|95.0|-0.1|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 6-- Emraclidine 10 mg versus Placebo||0.1|-0.1|=0.6729
70974149|NCT05227690|141455344|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.06|=|0.3783|TWO_SIDED|95.0|-0.1|0.2|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 3-- Emraclidine 30 mg versus Placebo||0.2|-0.1|=0.3783
70974150|NCT05227690|141455344|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.06|=|0.2242|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 3-- Emraclidine 10 mg versus Placebo||0.0|-0.2|=0.2242
70974151|NCT05227690|141455344|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05|=|0.8626|TWO_SIDED|95.0|-0.1|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 6-- Emraclidine 30 mg versus Placebo||0.1|-0.1|=0.8626
70974152|NCT05227690|141455344|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05|=|0.6106|TWO_SIDED|95.0|-0.1|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 6-- Emraclidine 10 mg versus Placebo||0.1|-0.1|=0.6106
70974153|NCT05227690|141455345|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.03|=|0.4219|TWO_SIDED|95.0|0.0|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 3-- Emraclidine 30 mg versus Placebo||0.1|0.0|=0.4219
70974154|NCT05227690|141455345|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.03|=|0.3933|TWO_SIDED|95.0|0.0|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 3-- Emraclidine 10 mg versus Placebo||0.1|0.0|=0.3933
71033131|NCT05342597|141576135|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|1.025|||||TWO_SIDED|90.0|0.931|1.128|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.128|0.931|
71033132|NCT05342597|141576135|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|0.959|||||TWO_SIDED|90.0|0.871|1.056|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.056|0.871|
71095160|NCT01529268|141698601|SUPERIORITY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in HOMA-IR on treatment group and baseline HOMA-IR value.|Adjusted difference in mean changes|-2.6||||0.15|TWO_SIDED|95.0|-6.2|1.0|||ANCOVA|Adjusted for baseline HOMA-IR.||Adjusted difference in mean changes in HOMA-IR. The change in HOMA-IR is adjusted for the baseline HOMA-IR value; therefore, the adjusted difference in mean changes is not equal to the net change.||1.0|-6.2|0.15
70974155|NCT05227690|141455345|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.02|=|0.7366|TWO_SIDED|95.0|0.0|0.0|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 6-- Emraclidine 30 mg versus Placebo||0.0|0.0|=0.7366
71095161|NCT01529268|141698602|SUPERIORITY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in systolic blood pressure on treatment group and baseline systolic blood pressure value.|Adjusted difference in mean changes|1.0||||0.71|TWO_SIDED|95.0|-3.0|4.0|||ANCOVA|Adjusted for baseline systolic blood pressure.||Adjusted difference in mean changes in systolic blood pressure. The change in systolic blood pressure is adjusted for the baseline systolic blood pressure value; therefore, the adjusted difference in mean changes is not equal to the net change.||4|-3|0.71
71154187|NCT03100149|141801024|SUPERIORITY||Difference in Adjusted Means|-0.61|STANDARD_ERROR_OF_MEAN|0.324||0.0628|TWO_SIDED|80.0|-1.02|-0.19||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Resting Tremor||-0.19|-1.02|0.0628
70974156|NCT05227690|141455345|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.02|=|0.4639|TWO_SIDED|95.0|-0.1|0.0|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 6-- Emraclidine 10 mg versus Placebo||0.0|-0.1|=0.4639
70974157|NCT04033367|141455346|SUPERIORITY||Least square mean difference|-15.52|||<|0.001|TWO_SIDED|95.0|-24.13|-6.9||Threshold of significance at 0.05.|Mixed Models Analysis||Dupilumab versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when primary outcome measure was statistically significant at two-sided 0.05 level.||-6.90|-24.13|<0.001
71033133|NCT05342597|141576135|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|0.91|||||TWO_SIDED|90.0|0.827|1.002|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.002|0.827|
71033134|NCT05342597|141576135|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|0.801|||||TWO_SIDED|90.0|0.712|0.901|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||0.901|0.712|
70974158|NCT04033367|141455347|SUPERIORITY||Least square mean difference|-27.87|||<|0.001|TWO_SIDED|95.0|-37.96|-17.78||Threshold of significance at 0.05.|Mixed Models Analysis||Dupilumab versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05 level.||-17.78|-37.96|<0.001
70974159|NCT04033367|141455348|SUPERIORITY||Least square mean difference|-15.06|||<|0.001|TWO_SIDED|95.0|-20.56|-9.56||Threshold of significance at 0.05.|Mixed Models Analysis||Dupilumab versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05 level.||-9.56|-20.56|<0.001
70974160|NCT04033367|141455349|SUPERIORITY||Least square mean difference|-2.08|||<|0.001|TWO_SIDED|95.0|-2.97|-1.18||Threshold of significance at 0.05.|Mixed Models Analysis||Dupilumab versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05 level.||-1.18|-2.97|<0.001
71033135|NCT05342597|141576136|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|1.083|||||TWO_SIDED|90.0|0.821|1.429|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.429|0.821|
71033136|NCT05342597|141576136|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|0.872|||||TWO_SIDED|90.0|0.661|1.15|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.150|0.661|
71033137|NCT05342597|141576136|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|0.82|||||TWO_SIDED|90.0|0.621|1.082|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.082|0.621|
71033138|NCT05342597|141576136|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|0.536|||||TWO_SIDED|90.0|0.362|0.794|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||0.794|0.362|
71033139|NCT02576938|141576153|SUPERIORITY||||||=|0.065|||||||Chi-squared|||||||=0.065
71033140|NCT02576938|141576153|SUPERIORITY||||||=|0.027|||||||Chi-squared|||||||=0.027
70974161|NCT04033367|141455350|SUPERIORITY||Least square mean difference|-3.61|||<|0.001|TWO_SIDED|95.0|-5.68|-1.53||Threshold of significance at 0.05.|Mixed Models Analysis||Dupilumab versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-1.53|-5.68|<0.001
70974162|NCT04033367|141455351|SUPERIORITY||Least square mean difference|9.97||||0.297|TWO_SIDED|95.0|-8.86|28.79||Threshold of significance at 0.05.|Mixed Models Analysis||Dupilumab versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||28.79|-8.86|0.297
70974163|NCT03193398|141455373|OTHER||Mean Difference (Net)|-1.3||||0.5939|TWO_SIDED|95.0|-6.3|3.6|||MMRM|MMRM: mixed model for repeated measures||Difference in LS Means (BTRX-246040 - Placebo)||3.6|-6.3|0.5939
70974164|NCT03193398|141455374|OTHER||Mean Difference (Net)|-1.0||||0.5503|TWO_SIDED|95.0|-4.4|2.3|||MMRM|MMRM: mixed model for repeated measures||Analysis of Change from Baseline in Investigator-administered MADRS-6 Total Score at week 8||2.3|-4.4|0.5503
70974165|NCT03193398|141455375|OTHER||Mean Difference (Net)|0.8||||0.3906|TWO_SIDED|95.0|-1.1|2.8|||MMRM|MMRM: mixed model for repeated measures||||2.8|-1.1|0.3906
70974166|NCT03193398|141455376|OTHER||Mean Difference (Net)|0.9||||0.4187|TWO_SIDED|95.0|-1.3|3.1||+/-|MMRM|MMRM: mixed model for repeated measures||||3.1|-1.3|0.4187
70974167|NCT03193398|141455377|OTHER||Mean Difference (Net)|-3.0||||0.4869|TWO_SIDED|95.0|-11.5|5.5|||MMRM|MMRM: mixed model for repeated measures||||5.5|-11.5|0.4869
70974168|NCT03193398|141455378|OTHER||Mean Difference (Net)|1.2||||0.5178|TWO_SIDED|95.0|-2.4|4.7|||MMRM|MMRM: mixed model for repeated measures||||4.7|-2.4|0.5178
70974169|NCT03823391|141455383|SUPERIORITY||Least Squares (LS) Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.215||0.022|TWO_SIDED|90.0|-0.89|-0.15|||Mixed-effect model repeated measurement|Analysis includes treatment, visit, stratification factors, and treatment-by-visit interaction as fixed factors and Baseline value as covariate.|Between groups difference was a single-arm comparison of LS mean of ABBV-3373 estimated from the MMRM model above minus the historical mean of adalimumab (-2.13).|Two primary comparisons were performed between ABBV-3373 and adalimumab. The first was the comparison of ABBV-3373 to historical adalimumab reference value -2.13 based on a meta-analysis consisting of 242 subjects from 3 historical adalimumab studies in which the success criterion was 2-sided P value ≤ 0.1.||-0.15|-0.89|0.022
71033141|NCT00838630|141576165|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be performed for the log-transformed AUC0-t, AUC0-inf and Cmax parameters.|Geometric Test/Ref Ratio x 100|98.27||||||90.0|92.32|104.61|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.61|92.32|
71033142|NCT00838630|141576166|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be performed for log-transformed AUC0-t, AUC0-inf, and Cmax parameters.|Geometric Test/Ref Ratio x 100|94.37||||||90.0|90.47|98.43|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||98.43|90.47|
71033143|NCT00838630|141576167|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax parameters.|Geometric Test/Ref Ratio x 100|95.7||||||90.0|91.52|100.08|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100.08|91.52|
71033144|NCT00838279|141576182|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.31||||||90.0|97.82|102.85|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.85|97.82|
71033145|NCT00838279|141576183|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|101.78||||||90.0|99.09|104.55|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.55|99.09|
71033146|NCT00838279|141576184|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|99.94||||||90.0|97.4|102.55|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.55|97.40|
71033147|NCT00838136|141576185|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|101.23||||||90.0|99.88|102.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.60|99.88|
71033148|NCT00838136|141576186|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|101.87||||||90.0|99.18|104.63|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.63|99.18|
71033149|NCT00838136|141576187|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.76||||||90.0|98.6|102.97|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.97|98.60|
71033150|NCT05323396|141576222|OTHER|||||||0.19|||||||Student's unpaired t-test|||||||0.19
71033151|NCT05323396|141576223|OTHER|||||||0.85|||||||Student's unpaired t-test|||||||0.85
71033152|NCT05323396|141576224|OTHER|||||||0.77|||||||Student's unpaired t-test|||||||0.77
71033153|NCT05323396|141576225|OTHER|||||||0.12|||||||student's unpaired t-test|||||||0.12
71033154|NCT05323396|141576226|OTHER|||||||0.81|||||||student's unpaired t-test|||||||0.81
71033155|NCT05323396|141576227|OTHER|||||||0.65|||||||student's unpaired t-test|||||||0.65
71033156|NCT01110005|141576228|SUPERIORITY||Risk Ratio (RR)|1.3||||0.34|TWO_SIDED|95.0|0.7|2.3|||Regression, log binomial|The regression model adjusted for site of recruitment as a covariate.|D5LR vs. LR|||2.3|0.7|0.34
71095162|NCT01529268|141698603|SUPERIORITY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in diastolic blood pressure on treatment group and baseline diastolic blood pressure value.|Adjusted difference in mean changes|-1.0||||0.31|TWO_SIDED|95.0|-4.0|1.0|||ANCOVA|Adjusted for baseline diastolic blood pressure.||Adjusted difference in mean changes in diastolic blood pressure. The change in diastolic blood pressure is adjusted for the baseline diastolic blood pressure value; therefore, the adjusted difference in mean changes is not equal to the net change.||1|-4|0.31
71095163|NCT01529268|141698604|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in self-reported Physical Health summary score on treatment group and baseline value of the Physical Health summary score.|Adjusted difference in mean changes|-1.0||||0.77|TWO_SIDED|95.0|-5.0|3.0|||ANCOVA|Adjusted for baseline self-reported Physical Health summary score.||Adjusted difference in mean changes from baseline in self-reported Physical Health summary score from the Pediatric Quality of Life Inventory (PedsQL). The difference in mean changes in Physical Health summary score is adjusted for the baseline Physical Health summary score; therefore, the adjusted difference in mean changes is not equal to the net change. Higher scores indicate better health-related quality of life.||3|-5|0.77
71095164|NCT01529268|141698604|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in Pyschosocial Health summary score on treatment group and baseline Psychosocial Health summary score.|Adjusted difference in mean changes|-1.0||||0.64|TWO_SIDED|95.0|-5.0|3.0|||ANCOVA|Adjusted for baseline Psychosocial Health summary score.||Adjusted difference in mean changes from baseline in self-reported Psychosocial Health summary score from the Pediatric Quality of Life Inventory (PedsQL). The difference in mean changes in Psychosocial Health summary score is adjusted for the baseline Psychosocial Health summary score; therefore, the adjusted difference in mean changes is not equal to the net change. Higher scores indicate better health-related quality of life.||3|-5|0.64
71095165|NCT01529268|141698604|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in parent/guardian-reported Physical Health summary score on treatment group and baseline value of the parent/guardian-reported Physical Health summary score.|Adjusted difference in mean changes|-2.0||||0.58|TWO_SIDED|95.0|-9.0|5.0|||ANCOVA|Adjusted for baseline parent/guardian-reported Physical Health summary score.||Adjusted difference in mean changes from baseline in parent/guardian-reported Physical Health summary score from the Pediatric Quality of Life Inventory (PedsQL). The difference in mean changes in parent/guardian-reported Physical Health summary score is adjusted for the baseline parent/guardian-reported Physical Health summary score; therefore, the adjusted difference in mean changes is not equal to the net change. Higher scores indicate better health-related quality of life.||5|-9|0.58
71095166|NCT01529268|141698604|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in parent/guardian-reported Psychosocial Health summary score on treatment group and baseline value of the parent/guardian-reported Psychosocial Health summary score.|Adjusted difference in mean changes|-1.0||||0.85|TWO_SIDED|95.0|-6.0|5.0|||ANCOVA|||Adjusted difference in mean changes from baseline in parent/guardian-reported Psychosocial Health summary score from the Pediatric Quality of Life Inventory (PedsQL). The difference in mean changes in parent/guardian-reported Psychosocial Health summary score is adjusted for the baseline parent/guardian-reported Psychosocial Health summary score; therefore, the adjusted difference in mean changes is not equal to the net change. Higher scores indicate better health-related quality of life.||5|-6|0.85
71095167|NCT01529268|141698605|SUPERIORITY||Mean Difference (Final Values)|-2.7||||0.11|TWO_SIDED||||||ANCOVA|||||||0.11
71095168|NCT00699751|141698628|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.691||||5e-05|TWO_SIDED|95.0|0.578|0.827|||Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of overall survival, and also for the secondary endpoints, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||0.827|0.578|0.00005
71095169|NCT00699751|141698629|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.169|||<|1e-05|TWO_SIDED|95.0|0.131|0.22|||Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of time to total ALP progression, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||0.22|0.131|<0.00001
71095170|NCT00699751|141698630|SUPERIORITY_OR_OTHER||||||<|0.001||||||\>=30% reduction in blood level|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=30% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
71095171|NCT00699751|141698630|SUPERIORITY_OR_OTHER||||||<|0.001||||||\>=50% reduction in blood level|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=50% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
71095172|NCT00699751|141698630|SUPERIORITY_OR_OTHER||||||<|0.001||||||Confirmed Total ALP Response (\>=30%)|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Confirmed Total ALP Response (\>=30%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
71154188|NCT03100149|141801024|SUPERIORITY||Difference in Adjusted Means|-0.41|STANDARD_ERROR_OF_MEAN|0.325||0.2125|TWO_SIDED|80.0|-0.82|0.01||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Resting Tremor||0.01|-0.82|0.2125
71154189|NCT03100149|141801024|SUPERIORITY||Difference in Adjusted Means|-0.08|STANDARD_ERROR_OF_MEAN|0.108||0.4577|TWO_SIDED|80.0|-0.22|0.06||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Axial Symptoms||0.06|-0.22|0.4577
70974170|NCT03823391|141455383|SUPERIORITY|||||||0.899||||||Posterior probability|Historical data borrowing|Based on posterior distribution of means for each group, the probability of Treatment mean - Control mean \< 0 given the observed data was calculated.||The second comparison was ABBV-3373 to adalimumab with combined in-trial and borrowed historical adalimumab data using a Bayesian historical borrowing approach in which the success criterion was posterior probability of ABBV-3373 being better than adalimumab \> 95%. When borrowing 30 historical adalimumab subjects, the combined least squares mean change from Baseline was -2.29.||||0.899
70974171|NCT03823391|141455383|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.353||0.683|TWO_SIDED|90.0|-0.74|0.45|||Mixed Effect Model Repeated Measurement|Analysis includes treatment, visit, stratification factors, and treatment-by-visit interaction as fixed factors and Baseline value as covariate.|Treatment difference = ABBV-3373 - Adalimumab|The mean difference in change from Baseline in DAS28 (CRP) at Week 12 between ABBV-3373 and adalimumab was also estimated only based on in-study data.||0.45|-0.74|0.683
71033157|NCT01110005|141576229|SUPERIORITY||Risk Ratio (RR)|1.1||||0.4|TWO_SIDED|95.0|0.9|1.3|||Regression, log binomial|The regression model adjusted for site of recruitment as a covariate.|D5LR vs. LR|||1.3|0.9|0.40
71033158|NCT01110005|141576230|SUPERIORITY|||||||0.69|||||||Cochran-Mantel-Haenszel|This method was used to control for site of recruitment||||||0.69
71033159|NCT00731783|141576248|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||1|TWO_SIDED|95.0|0.54|1.97|||Fisher Exact|||||1.97|0.54|1.00
71033160|NCT00731783|141576249|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.05|TWO_SIDED|95.0|1.03|4.55|||Fisher Exact|||||4.55|1.03|0.05
71033161|NCT00731783|141576250|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.49|TWO_SIDED|95.0|0.39|1.52|||Fisher Exact|||||1.52|0.39|0.49
71033162|NCT00731783|141576251|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.28|TWO_SIDED|95.0|0.77|3.28|||Fisher Exact|||||3.28|0.77|0.28
71095173|NCT00699751|141698630|SUPERIORITY_OR_OTHER||||||<|0.001||||||Confirmed Total ALP Response (\>=50%)|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Confirmed Total ALP Response (\>=50%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
71033163|NCT00731783|141576252|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52||||0.12|TWO_SIDED|95.0|0.23|1.16|||Fisher Exact|||||1.16|0.23|0.12
71095174|NCT00699751|141698631|SUPERIORITY_OR_OTHER||||||<|0.001||||||\>=30% reduction in blood level|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=30% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
71095175|NCT00699751|141698631|SUPERIORITY_OR_OTHER||||||<|0.001||||||\>=50% reduction in blood level|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=50% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
71033164|NCT00731783|141576253|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42||||0.02|TWO_SIDED|95.0|0.21|0.85|||Fisher Exact|||||0.85|0.21|0.02
71033165|NCT00731783|141576254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.39||||0.008|TWO_SIDED|95.0|0.2|0.77|||Fisher Exact|||||0.77|0.20|0.008
71033166|NCT00731783|141576255|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.02|TWO_SIDED|95.0|0.22|0.86|||Fisher Exact|||||0.86|0.22|0.02
71033167|NCT00467896|141576272|SUPERIORITY_OR_OTHER||Mean Difference (Net)|49.8|||<|0.0001|TWO_SIDED|95.0|39.55|60.15|||t-test, 2 sided|||Comparison of the change in inhalation-times rate from Period I (PD-6) to Period II (PD-15)||60.15|39.55|<0.0001
71033168|NCT03772522|141576273|SUPERIORITY||Cohen's d (effect size)|0.384||||0.428|TWO_SIDED||||||t-test, 2 sided|||Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks).||||0.428
71033169|NCT03772522|141576273|SUPERIORITY||Cohen's d (effect size)|-0.46||||0.058|TWO_SIDED||||||t-test, 2 sided|||Comparison of scores at baseline (pre-intervention) and immediately post-intervention.||||0.058
71033170|NCT03772522|141576273|SUPERIORITY||Cohen's d (effect size)|-0.4||||0.095|TWO_SIDED||||||t-test, 2 sided|||Comparison of scores at baseline (pre-intervention) and 3-month post-intervention.||||0.095
71033171|NCT03772522|141576273|SUPERIORITY||Cohen's d (effect size)|-0.73||||0.005|TWO_SIDED||||||t-test, 2 sided|||Comparison of scores at baseline (pre-intervention) and 6-months post-intervention.||||0.005
71033172|NCT03772522|141576273|SUPERIORITY||Cohen's d (effect size)|-0.6||||0.022|TWO_SIDED||||||t-test, 2 sided|||Comparison of scores at baseline (pre-intervention) and 9-months post-intervention.||||0.022
71033173|NCT03772522|141576274|SUPERIORITY||Cohen's d (effect size)|1.792||||0.002|TWO_SIDED||||||t-test, 2 sided|||Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks) for the physical component of the CIS.||||0.002
71033174|NCT03772522|141576274|SUPERIORITY||Cohen's d (effect size)|0.047||||0.923|TWO_SIDED||||||t-test, 2 sided|||Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks) for the psychological component of the CIS.||||0.923
71033175|NCT03772522|141576274|SUPERIORITY||Cohen's d (effect size)|0.6||||0.18|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (physical component) scores at baseline (pre-intervention) and immediately post-intervention.||||0.18
71033176|NCT03772522|141576274|SUPERIORITY||Cohen's d (effect size)|0.2||||0.388|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (psychological component) scores at baseline (pre-intervention) and immediately post-intervention.||||0.388
71033177|NCT03772522|141576274|SUPERIORITY||Cohen's d (effect size)|0.52||||0.037|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (physical component) scores at baseline (pre-intervention) and 3-months post-intervention.||||0.037
70974172|NCT03823391|141455384|SUPERIORITY||LS Mean Difference|-1.69|STANDARD_ERROR_OF_MEAN|3.207||0.601|TWO_SIDED|90.0|-7.08|3.7|||Mixed Effect Model Repeated Measurement|Analysis includes treatment, visit, stratification factors, and treatment-by-visit interaction as fixed factors and Baseline value as covariate.|Treatment difference = ABBV-3373 - Adalimumab|||3.70|-7.08|0.601
70974173|NCT03823391|141455385|SUPERIORITY||LS Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|3.205||0.737|TWO_SIDED|90.0|-6.47|4.3|||Mixed Effect Model Repeated Measurement|Analysis includes treatment, visit, stratification factors, and treatment-by-visit interaction as fixed factors and Baseline value as covariate.|Treatment difference = ABBV-3373 - Adalimumab|||4.30|-6.47|0.737
70974174|NCT03823391|141455386|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.418||0.612|TWO_SIDED|90.0|-0.92|0.49|||Mixed Effect Model Repeated Measurement|Analysis included treatment, visit, stratification factors, and treatment-by-visit interaction as fixed factors and Baseline value as covariate.|Treatment difference = ABBV-3373 - Adalimumab|||0.49|-0.92|0.612
70974175|NCT03823391|141455387|SUPERIORITY||Response Rate Difference|-4.0||||0.877|TWO_SIDED|90.0|-28.5|20.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factors.|Response rate difference = ABBV-3373 - Adalimumab|||20.5|-28.5|0.877
70974176|NCT03823391|141455388|SUPERIORITY||Response Rate Difference|-13.1||||0.426|TWO_SIDED|90.0|-37.2|11.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for stratification factors.|Response rate difference = ABBV-3373 - Adalimumab|||11.0|-37.2|0.426
70974177|NCT05030311|141455397|SUPERIORITY||Mean Difference (Final Values)|-6.22|STANDARD_ERROR_OF_MEAN|1.136|<|0.001|TWO_SIDED|95.0|-8.45|-4.0|||Mixed Models Analysis||MMRM adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, visit week, baseline score and both interaction of treatment by visit week and interaction of baseline score by visit week.|||-4.00|-8.45|<0.001
70974178|NCT05030311|141455398|SUPERIORITY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|0.544|<|0.001|TWO_SIDED|95.0|-3.7|-1.56|||Mixed Models Analysis||MMRM adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, visit week, baseline score and both interaction of treatment by visit week and interaction of baseline score by visit week.|ISS7 at Week 12 (Scenario 2 with ISS7 and HSS7 as co-primary efficacy endpoints)||-1.56|-3.70|<0.001
71033178|NCT03772522|141576274|SUPERIORITY||Cohen's d (effect size)|0.09||||0.688|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (psychological component) scores at baseline (pre-intervention) and 3-months post-intervention.||||0.688
71033179|NCT03772522|141576274|SUPERIORITY||Cohen's d (effect size)|0.51||||0.038|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (physical component) scores at baseline (pre-intervention) and 6-months post-intervention.||||0.038
71033180|NCT03772522|141576274|SUPERIORITY||Cohen's d (effect size)|0.01||||0.956|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (psychological component) scores at baseline (pre-intervention) and 6-months post-intervention.||||0.956
71033181|NCT03772522|141576274|SUPERIORITY||Cohen's d (effect size)|0.32||||0.197|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (physical component) scores at baseline (pre-intervention) and 9-months post-intervention.||||0.197
71033182|NCT03772522|141576274|SUPERIORITY||Cohen's d (effect size)|-0.07||||0.762|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (psychological component) scores at baseline (pre-intervention) and 9-months post-intervention.||||0.762
71033183|NCT03772522|141576275|SUPERIORITY||Cohen's d (effect size)|0.101||||0.834|TWO_SIDED||||||t-test, 2 sided|||Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks).||||0.834
71033184|NCT03772522|141576275|SUPERIORITY||Cohen's d (effect size)|0.19||||0.417|TWO_SIDED||||||t-test, 2 sided|||Comparison of SCS scores at baseline (pre-intervention) and immediately post-intervention.||||0.417
71033185|NCT03772522|141576275|SUPERIORITY||Cohen's d (effect size)|0.42||||0.087|TWO_SIDED||||||t-test, 2 sided|||Comparison of SCS scores at baseline (pre-intervention) and 3-months post-intervention.||||0.087
71033186|NCT03772522|141576275|SUPERIORITY||Cohen's d (effect size)|0.33||||0.168|TWO_SIDED||||||t-test, 2 sided|||Comparison of SCS scores at baseline (pre-intervention) and 6-months post-intervention.||||0.168
71033187|NCT03772522|141576275|SUPERIORITY||Cohen's d (effect size)|0.37||||0.133|TWO_SIDED||||||t-test, 2 sided|||Comparison of SCS scores at baseline (pre-intervention) and 9-months post-intervention.||||0.133
71033188|NCT03772522|141576276|SUPERIORITY||Cohen's d (effect size)|1.161||||0.026|TWO_SIDED||||||t-test, 2 sided|||Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks).||||0.026
71033189|NCT03772522|141576276|SUPERIORITY||Cohen's d (effect size)|0.62||||0.014|TWO_SIDED||||||t-test, 2 sided|||Comparison of RSS scores at baseline (pre-intervention) and immediately post-intervention.||||0.014
71033190|NCT03772522|141576276|SUPERIORITY||Cohen's d (effect size)|0.29||||0.217|TWO_SIDED||||||t-test, 2 sided|||Comparison of RSS scores at baseline (pre-intervention) and 3-months post-intervention.||||0.217
71033191|NCT03772522|141576276|SUPERIORITY||Cohen's d (effect size)|0.71||||0.006|TWO_SIDED||||||t-test, 2 sided|||Comparison of RSS scores at baseline (pre-intervention) and 6-months post-intervention.||||0.006
71033192|NCT03772522|141576276|SUPERIORITY||Cohen's d (effect size)|0.53||||0.039|TWO_SIDED||||||t-test, 2 sided|||Comparison of RSS scores at baseline (pre-intervention) and 9-months post-intervention.||||0.039
71033193|NCT00834795|141576282|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|95.16||||||90.0|85.69|105.67|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.67|85.69|
71033194|NCT00834795|141576283|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.27||||||90.0|90.34|102.59|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||102.59|90.34|
71033195|NCT00834795|141576284|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.36||||||90.0|90.2|102.93|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||102.93|90.20|
70974179|NCT05030311|141455399|SUPERIORITY||Mean Difference (Final Values)|-3.61|STANDARD_ERROR_OF_MEAN|0.635|<|0.001|TWO_SIDED|95.0|-4.85|-2.36|||Mixed Models Analysis||MMRM adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, visit week, baseline score and both interaction of treatment by visit week and interaction of baseline score by visit week.|HSS7 at Week 12 (Scenario 2 with ISS7 and HSS7 as co-primary efficacy endpoints)||-2.36|-4.85|<0.001
71033196|NCT00579345|141576290|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if lower limit of the 2-sided 95% Clopper-Pearson confidence interval (CI) of the ratio of the postvaccination (Day 22) Geometric Mean Titers (FLU+PV/FLU vaccine alone) was greater than 0.5.|Ratio of GMTs|0.66|||||TWO_SIDED|95.0|0.45|0.98|||||A/H1N1(Day22)|The non-inferiority null hypothesis stated that the FLU+PV vaccine group was non-inferior to the FLU alone group if the lower limit of the 95% CI of the ratio of GMTs between vaccines (FLU+PV/FLU alone) on day 22 was greater than 0.5 for all three vaccine strains.||0.98|0.45|
70974180|NCT05030311|141455400|SUPERIORITY||Odds Ratio (OR)|3.11|||<|0.001|TWO_SIDED|95.0|2.0|4.84|||Regression, Logistic|Logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, and baseline UAS7 score.||Disease activity control (UAS7 =\< 6) at Week 12||4.84|2.00|<0.001
71033197|NCT00579345|141576290|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if lower limit of the 2-sided 95% Clopper-Pearson confidence interval (CI) of the ratio of the postvaccination (Day 22) Geometric Mean Titers (FLU+PV/FLU vaccine alone) was greater than 0.5.|Ratio of GMTs|0.81|||||TWO_SIDED|95.0|0.55|1.19|||||A/H3N2 (Day 22)-criterion was met|The non-inferiority null hypothesis stated that the FLU+PV vaccine group was non-inferior to the FLU alone group if the lower limit of the 95% CI of the ratio of GMTs between vaccines (FLU+PV/FLU alone) on day 22 was greater than 0.5 for all three vaccine strains.||1.19|0.55|
70974181|NCT05030311|141455401|SUPERIORITY||Odds Ratio (OR)|3.83|||<|0.001|TWO_SIDED|95.0|2.16|6.82|||Regression, Logistic|Logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, and baseline UAS7 score.||Complete absence of hives and itch (UAS7 = 0) at Week 12||6.82|2.16|<0.001
70974182|NCT05030311|141455402|SUPERIORITY||Odds Ratio (OR)|15.67|||<|0.001|TWO_SIDED|95.0|6.18|39.77|||Regression, Logistic||Statistical model used logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, and baseline UAS7 score.|||39.77|6.18|<0.001
70974183|NCT05030311|141455403|SUPERIORITY||Rate ratio|2.69|||<|0.001|TWO_SIDED|95.0|2.01|3.61|||Negative binomial regression model|Negative binomial regression model with log link, using treatment arm, geographical region, and prior exposure to anti-IgE biologics as covariates.||||3.61|2.01|<0.001
71033198|NCT00579345|141576290|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if lower limit of the 2-sided 95% Clopper-Pearson confidence interval (CI) of the ratio of the postvaccination (Day 22) Geometric Mean Titers (FLU+PV/FLU vaccine alone) was greater than 0.5.|Ratio of GMTs|0.69|||||TWO_SIDED|95.0|0.46|1.02|||||B (Day 22)|The non-inferiority null hypothesis stated that the FLU+PV vaccine group was non-inferior to the FLU alone group if the lower limit of the 95% CI of the ratio of GMTs between vaccines (FLU+PV/FLU alone) on day 22 was greater than 0.5 for all three vaccine strains.||1.02|0.46|
71033199|NCT03697109|141576294|EQUIVALENCE|Log odds is equal to 0 (null hypothesis) vs log odds not equal to 0 (alternative hypothesis).|Odds Ratio (OR)|0.17||||0.0215|TWO_SIDED|95.0|0.04|0.77|||Chi-squared||An odds ratio (OR) \<1 represents lower odds of loss of response under treatment with relacorilant compared with treatment with placebo.|A logistic regression model with logit link function was used in order to detect if there was a significant difference in total number of patients with a loss of response with respect to HTN under treatment with relacorilant compared with treatment with placebo in the RW Phase.||0.77|0.04|0.0215
71095176|NCT00699751|141698631|SUPERIORITY_OR_OTHER||||||<|0.001||||||Confirmed Total ALP Response (\>=50%)|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Confirmed Total ALP Response (\>=50%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
71154190|NCT03100149|141801024|SUPERIORITY||Difference in Adjusted Means|-0.01|STANDARD_ERROR_OF_MEAN|0.109||0.9182|TWO_SIDED|80.0|-0.15|0.13||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Axial Symptoms||0.13|-0.15|0.9182
70974184|NCT05030311|141455404|SUPERIORITY||Odds Ratio (OR)|2.44|||<|0.001|TWO_SIDED|95.0|1.53|3.9|||Regression, Logistic||Statistical model used logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics and baseline DLQI score.|||3.90|1.53|<0.001
70974185|NCT05030311|141455405|SUPERIORITY||Rate ratio|1.25|||<|0.001|TWO_SIDED|95.0|1.12|1.41|||Regression, Linear||Statistical model used a negative binomial regression with log link included treatment arm as fixed effect, geographical region, prior exposure to anti-IgE biologics, baseline AAS7 = 0 response as covariates.|Angioedema occurrence-free weeks (AAS7 = 0 response) up to Week 12||1.41|1.12|<0.001
70974186|NCT03083886|141455407|SUPERIORITY||Risk Ratio (RR)|0.93||||0.04|TWO_SIDED|95.0|0.87|0.997|||GEE with log link and Poisson errors|||||.997|.87|.04
71154191|NCT03100149|141801025|SUPERIORITY||LS Means Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.3582|TWO_SIDED|80.0|-0.05|0.01||Nominal p-values are displayed for descriptive purposes only.|ANCOVA|||||0.01|-0.05|0.3582
71154192|NCT03100149|141801025|SUPERIORITY||LS Means Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.02||0.1955|TWO_SIDED|80.0|-0.06|0.0||Nominal p-values are displayed for descriptive purposes only.|ANCOVA|||||0.00|-0.06|0.1955
71154193|NCT03100149|141801026|SUPERIORITY||Difference in Adjusted Means|0.22|STANDARD_ERROR_OF_MEAN|0.245||0.3611|TWO_SIDED|80.0|-0.09|0.54||Nominal p-values are displayed for descriptive purposes only.|ANCOVA|||||0.54|-0.09|0.3611
70974187|NCT03083886|141455407|SUPERIORITY||Risk Ratio (RR)|1.4|||<|0.001|TWO_SIDED|95.0|1.35|1.45|||GEE with log link and Poisson errors|||||1.45|1.35|<0.001
70974188|NCT03083886|141455408|SUPERIORITY||Risk Difference (RD)|-5.8|||<|0.001|TWO_SIDED|95.0|-7.7|-3.9|||GEE with identity link and normal errors|||||-3.9|-7.7|<0.001
70974189|NCT03083886|141455408|SUPERIORITY||Risk Difference (RD)|-4.3|||<|0.001|TWO_SIDED|95.0|-5.9|-2.6|||GEE with identity link and normal errors|||||-2.6|-5.9|<0.001
70974190|NCT03083886|141455409|SUPERIORITY||Risk Difference (RD)|-7.5|||<|0.001|TWO_SIDED|95.0|-9.4|-5.7|||GEE with identity link and normal errors|||||-5.7|-9.4|<0.001
70974191|NCT03083886|141455409|SUPERIORITY||Risk Difference (RD)|-6.7|||<|0.001|TWO_SIDED|95.0|-8.4|-5.0|||GEE with identity link and normal errors|||||-5.0|-8.4|<0.001
70974192|NCT03083886|141455410|SUPERIORITY||Risk Difference (RD)|4.7|||<|0.001|TWO_SIDED|95.0|2.6|6.8|||GEE with identity link and normal errors|||||6.8|2.6|<0.001
70974193|NCT03083886|141455410|SUPERIORITY||Risk Difference (RD)|6.0|||<|0.001|TWO_SIDED|95.0|4.1|7.9|||GEE with identity link and normal errors|||||7.9|4.1|<0.001
70974194|NCT03083886|141455411|SUPERIORITY||Risk Difference (RD)|6.8|||<|0.001|TWO_SIDED|95.0|5.0|8.7|||GEE with identity link and normal errors|||||8.7|5.0|<0.001
70974195|NCT03083886|141455411|SUPERIORITY||Risk Difference (RD)|6.7|||<|0.001|TWO_SIDED|95.0|5.0|8.4|||GEE with identity link and normal errors|||||8.4|5.0|<0.001
70974196|NCT00608985|141455413|SUPERIORITY_OR_OTHER||Median Difference (Net)|-15.0|||<|0.0001|TWO_SIDED|95.0|-21.8|-8.8|||Wilcoxon rank-sum|||Change from baseline to day 1\&2 compared with placebo||-8.8|-21.8|<0.0001
70974197|NCT00608985|141455413|SUPERIORITY_OR_OTHER||Median Difference (Net)|-26.8|||<|0.0001|TWO_SIDED|95.0|-34.3|-19.5|||Wilcoxon rank-sum|||Change from baseline to day 1\&2 compared with placebo||-19.5|-34.3|<0.0001
70974198|NCT00608985|141455413|SUPERIORITY_OR_OTHER||Median Difference (Net)|-6.8||||0.0376|TWO_SIDED|95.0|-13.5|-0.3|||Wilcoxon rank-sum|||Change from baseline to day 1\&2 compared with placebo||-0.3|-13.5|0.0376
70974199|NCT00608985|141455414|SUPERIORITY_OR_OTHER||Median Difference (Net)|-13.5||||0.0001|TWO_SIDED|95.0|-20.3|-6.5|||Wilcoxon rank-sum|||Change from baseline to day 15\&16 compared with placebo||-6.5|-20.3|0.0001
70974200|NCT00608985|141455414|SUPERIORITY_OR_OTHER||Median Difference (Net)|-19.5|||<|0.0001|TWO_SIDED|95.0|-27.3|-12.3|||Wilcoxon rank-sum|||Change from baseline to day 15\&16 compared with placebo||-12.3|-27.3|<0.0001
70974201|NCT00608985|141455414|SUPERIORITY_OR_OTHER||Median Difference (Net)|3.5||||0.3358|TWO_SIDED|95.0|-3.8|11.0|||Wilcoxon rank-sum|||Change from baseline to day 15\&16 compared with placebo||11.0|-3.8|0.3358
70974202|NCT00608985|141455415|SUPERIORITY_OR_OTHER||Median Difference (Net)|-7.3||||0.0186|TWO_SIDED|95.0|-13.3|-1.3|||Wilcoxon rank-sum|||Change from baseline to week 1\&2 compared with placebo||-1.3|-13.3|0.0186
71033200|NCT01415232|141576322|NON_INFERIORITY_OR_EQUIVALENCE|Balki et al found a Pearson's correlation coefficient between the UD and ND depth of 0.85 (95% CI 0.75-0.91). We believe EDE + US would result in a correlation coefficient of approximately 0.91. To keep the lower bound estimate within 0.04 of a correlation of 0.91, and to maintain a 95% confidence level, 140 patients would need to be sampled. To allow for patients who may not complete the study, 160 patients were enrolled.|correlation coefficient|0.91|||<|0.05|TWO_SIDED|95.0|0.87|0.93|||longitudinal correlation coefficient|||Pearson's correlation coefficient was calculated for epidural distance measurements which included actual clinical epidural needle depth (ND) and the epidural depth equation (EDE), ND and prior EDE + US midline longitudinal plane view, ND and prior EDE + US transverse plane view.||0.93|0.87|< 0.05
71033201|NCT01415232|141576322|NON_INFERIORITY_OR_EQUIVALENCE|correlation coefficient|transverse plane correlation coefficient|0.9|||>|0.85|TWO_SIDED|95.0|0.87|0.93|||transverse plane correlation coefficient|||Transverse plane correlation coefficient||0.93|0.87|>0.85
70974203|NCT00608985|141455415|SUPERIORITY_OR_OTHER||Median Difference (Net)|-10.4||||0.0006|TWO_SIDED|95.0|-16.4|-4.6|||Wilcoxon rank-sum|||Change from baseline to week 1\&2 compared with placebo||-4.6|-16.4|0.0006
70974204|NCT00608985|141455415|SUPERIORITY_OR_OTHER||Median Difference (Net)|-12.7|||<|0.0001|TWO_SIDED|95.0|-18.8|-6.6|||Wilcoxon rank-sum|||Change from baseline to week 1\&2 compared with placebo||-6.6|-18.8|<0.0001
70974205|NCT00608985|141455416|SUPERIORITY_OR_OTHER||Median Difference (Net)|-9.3||||0.0035|TWO_SIDED|95.0|-15.3|-3.0|||Wilcoxon rank-sum|||Change from baseline to day 1\&2 compared with placebo||-3.0|-15.3|0.0035
70974206|NCT00608985|141455416|SUPERIORITY_OR_OTHER||Median Difference (Net)|-9.5||||0.0006|TWO_SIDED|95.0|-15.0|-4.3|||Wilcoxon rank-sum|||Change from baseline to day 1\&2 compared with placebo||-4.3|-15.0|0.0006
70974207|NCT00608985|141455416|SUPERIORITY_OR_OTHER||Median Difference (Net)|-16.0|||<|0.0001|TWO_SIDED|95.0|-22.0|-9.8|||Wilcoxon rank-sum|||Change from baseline to day 1\&2 compared with placebo||-9.8|-22.0|<0.0001
71033202|NCT01415232|141576322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.64|STANDARD_DEVIATION|1.0|>|0.05|TWO_SIDED|95.0|6.5|6.8|||t-test, 2 sided|||Clinical epidural needle depth||6.8|6.5|>0.05
70974208|NCT00608985|141455417|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.0||||0.2237|TWO_SIDED|95.0|-11.0|2.5|||Wilcoxon rank-sum|||Change from baseline to day 15\&16 compared with placebo||2.5|-11.0|0.2237
70974209|NCT00608985|141455417|SUPERIORITY_OR_OTHER||Median Difference (Net)|-6.0||||0.0607|TWO_SIDED|95.0|-12.3|0.3|||Wilcoxon rank-sum|||Change from baseline to day 15\&16 compared with placebo||0.3|-12.3|0.0607
70974210|NCT00608985|141455417|SUPERIORITY_OR_OTHER||Median Difference (Net)|-10.5||||0.0017|TWO_SIDED|95.0|-17.3|-4.0|||Wilcoxon rank-sum|||Change from baseline to day 15\&16 compared with placebo||-4.0|-17.3|0.0017
70974211|NCT00608985|141455418|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.1||||0.1187|TWO_SIDED|95.0|-9.1|0.9|||Wilcoxon rank-sum|||Change from baseline to week 1\&2 compared with placebo||0.9|-9.1|0.1187
70974212|NCT00608985|141455418|SUPERIORITY_OR_OTHER||Median Difference (Net)|-7.1||||0.0017|TWO_SIDED|95.0|-11.5|-2.7|||Wilcoxon rank-sum|||Change from baseline to week 1\&2 compared with placebo||-2.7|-11.5|0.0017
70974213|NCT00608985|141455418|SUPERIORITY_OR_OTHER||Median Difference (Net)|-6.1||||0.0121|TWO_SIDED|95.0|-10.8|-1.4|||Wilcoxon rank-sum|||Change from baseline to week 1\&2 compared with placebo||-1.4|-10.8|0.0121
70974214|NCT00662792|141455428|SUPERIORITY||Difference of adjusted means|0.13|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.102|0.158|||ANOVA|Analysis of variance with terms for centre, patient with centre, treatment, and period.|(T+S\_PE) - (Salm50DPI)|H1: Superiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. salmeterol (Salm50DPI) for FEV1 AUC0-12||0.158|0.102|<0.0001
70974215|NCT00662792|141455428|SUPERIORITY||Difference of adjusted means|0.07|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.042|0.097|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (Tio18GEL)|H1: Superiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs Tiotropium (Tio18GEL) for FEV1 AUC0- 12||0.097|0.042|<.0001
70974216|NCT00662792|141455428|OTHER||Difference of adjusted means|-0.024|STANDARD_ERROR_OF_MEAN|0.014||0.0914|TWO_SIDED|95.0|-0.052|0.004|||ANOVA|Analysis of variance with terms for centre, patient with centre, treatment, and period. α = 0.025 one-sided|(T+S\_PE) - (T18GEL+S-DPI)|The Tiotropium free combination (T18GEL+S\_DPI) was included in order to characterise this treatment in comparison with the FDC Tiotropium/Salmeterol (T+S\_PE). No formal hypotheses were defined.||0.004|-0.052|0.0914
70921436|NCT04714320|141333624|SUPERIORITY||||||=|0.464||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 29||||=0.464
70921437|NCT04714320|141333624|SUPERIORITY||||||=|0.458||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 29||||=0.458
70921438|NCT04714320|141333624|SUPERIORITY||||||=|0.779||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 36||||=0.779
70921439|NCT04714320|141333624|SUPERIORITY||||||=|0.629||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 36||||=0.629
70921440|NCT04714320|141333624|SUPERIORITY||||||=|0.242||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 43||||=0.242
70921441|NCT04714320|141333624|SUPERIORITY||||||=|0.29||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 43||||=0.290
70921442|NCT04714320|141333624|SUPERIORITY||||||=|0.349||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 50||||=0.349
70921443|NCT04714320|141333624|SUPERIORITY||||||=|0.532||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 50||||=0.532
70921444|NCT04714320|141333624|SUPERIORITY||||||=|0.205||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 57||||=0.205
70921445|NCT04714320|141333624|SUPERIORITY||||||=|0.368||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 57||||=0.368
71033203|NCT01415232|141576322|SUPERIORITY_OR_OTHER||Formula calculation|6.54|STANDARD_DEVIATION|0.68|>|0.05|TWO_SIDED|95.0|6.44|6.65|||Formula calculation||Estimated epidural depth equation depth (cm)|Estimated epidural depth equation depth (cm)||6.65|6.44|>0.05
71033204|NCT00984022|141576331|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||Fisher Exact|||The percentages achieving 30% or greater reduction in the surface area of the abscess were compared with Fisher's exact test.||||.0003
71033205|NCT00984022|141576332|SUPERIORITY_OR_OTHER|||||||0.043||95.0||||Main effect for type of dressing.|ANOVA|||Repeated measures ANOVA using 2 X 2 factorial design, with one between-subjects factor (Group) and one within-subjects factor (Time). Null hypothesis is: The type of dressing does not affect patient pain ratings.||||.043
71033206|NCT00984022|141576333|SUPERIORITY_OR_OTHER|||||||0.847||95.0|||||Fisher Exact|||Fisher's exact test was used to compare the percentage of individuals achieving a 30% or greater reduction in cellulitis surface area between the Iodoform and Aquacel groups.||||.847
71033207|NCT00905606|141576335|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA guidelines.|Ratio of the LS Mean (test/ref x 100)|93.91||||||90.0|85.42|103.25|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.25|85.42|
71033208|NCT00905606|141576336|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA guidelines.|Ratio of the LS Mean (test/ref x 100)|98.27||||||90.0|94.63|102.05|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.05|94.63|
71033209|NCT00905606|141576337|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA guidelines.|Ratio of the LS Mean (test/ref x 100)|98.19||||||90.0|94.64|101.87|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.87|94.64|
71033210|NCT04523168|141576350|SUPERIORITY|||||||0.0137|||||||Wilcoxon (Mann-Whitney)|||Baseline, 120 days||||0.0137
71033211|NCT04523168|141576352|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71033212|NCT03868891|141576374|OTHER|||||||1|||||||Wilcoxon signed-rank|||inflation test at 2 months compared with baseline; EMST150 + Eustachi not included because visit 2 measurements only available for 1 participant (2 ears)||||1.00
71033213|NCT03868891|141576374|OTHER|||||||0.734|||||||Wilcoxon signed-rank|||deflation test at 2 months compared with baseline; EMST150 + Eustachi not included because visit 2 measurements only available for 1 participant (2 ears)||||0.734
71033214|NCT03868891|141576375|OTHER|||||||0.25|||||||Wilcoxon signed-rank|||inflation test at 4 months compared with baseline||||0.25
71033215|NCT03868891|141576375|OTHER|||||||0.75|||||||Wilcoxon signed-rank|||deflation test at 4 months compared with baseline||||0.75
71033216|NCT03868891|141576376|OTHER|||||||0.25|||||||Wilcoxon signed-rank|||inflation test at 4 months compared with 2 months||||0.25
71033217|NCT03868891|141576376|OTHER|||||||0.75|||||||Wilcoxon signed-rank|||deflation test at 4 months compared with 2 months||||0.75
71095177|NCT00699751|141698632|SUPERIORITY_OR_OTHER||||||<|0.001||||||Total ALP normalization|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Total ALP normalization, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
71095178|NCT00699751|141698633|SUPERIORITY_OR_OTHER||||||<|0.001||||||Percentage Change from Baseline|ANCOVA|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Percentage change from baseline, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
71095179|NCT00699751|141698634|SUPERIORITY_OR_OTHER||||||<|0.001||||||Maximum Percentage decrease from baseline to week 12|ANCOVA|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Maximum Percentage decrease from baseline to week 12, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
71095180|NCT00699751|141698635|SUPERIORITY_OR_OTHER||||||<|0.001||||||Percentage change from baseline|ANCOVA|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Percentage change from baseline, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
71095181|NCT00699751|141698636|SUPERIORITY_OR_OTHER||||||<|0.001||||||Maximum Percentage decrease from baseline during the 24 week treatment|ANCOVA|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Maximum Percentage decrease from baseline during the 24 week treatment, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
70921446|NCT04714320|141333624|SUPERIORITY||||||=|0.084||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 64||||=0.084
70921447|NCT04714320|141333624|SUPERIORITY||||||=|0.179||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 64||||=0.179
70921448|NCT04714320|141333624|SUPERIORITY||||||=|0.584||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 71||||=0.584
70921449|NCT04714320|141333624|SUPERIORITY||||||=|0.762||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 71||||=0.762
70921450|NCT04714320|141333624|SUPERIORITY||||||=|0.675||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 78||||=0.675
70921451|NCT04714320|141333624|SUPERIORITY||||||=|0.166||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 78||||=0.166
70921452|NCT04714320|141333624|SUPERIORITY||||||=|0.09||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 85||||=0.090
71154194|NCT03100149|141801026|SUPERIORITY||Difference in Adjusted Means|0.44|STANDARD_ERROR_OF_MEAN|0.243||0.0727|TWO_SIDED|80.0|0.13|0.75||Nominal p-values are displayed for descriptive purposes only.|ANCOVA|||||0.75|0.13|0.0727
70921453|NCT04714320|141333624|SUPERIORITY||||||=|0.488||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 85||||=0.488
70921454|NCT04714320|141333624|SUPERIORITY||||||=|0.218||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 92||||=0.218
70921455|NCT04714320|141333624|SUPERIORITY||||||=|0.232||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 92||||=0.232
70921456|NCT04714320|141333624|SUPERIORITY||||||=|0.421||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 106||||=0.421
70921457|NCT04714320|141333624|SUPERIORITY||||||=|0.815||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 106||||=0.815
71154195|NCT03100149|141801027|SUPERIORITY||Odds Ratio (OR)|0.77||||0.4265|TWO_SIDED|80.0|0.5|1.18||Nominal p-values are displayed for descriptive purposes only.|Regression, Logistic|||||1.18|0.50|0.4265
71095182|NCT00699751|141698637|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.643|||<|1e-05|TWO_SIDED|95.0|0.539|0.768||Time to Prostate Specific Antigen (PSA) progression|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to PSA progression, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||0.768|0.539|<0.00001
71095183|NCT00699751|141698638|SUPERIORITY_OR_OTHER||||||<|0.001||||||\>=30% reduction in blood level|Cochran-Mantel-Haenszel|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=30% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
71095184|NCT00699751|141698638|SUPERIORITY_OR_OTHER|||||||0.106||||||\>=50% reduction in blood level|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=50% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.106
71095185|NCT00699751|141698638|SUPERIORITY_OR_OTHER|||||||0.032||||||Confirmed PSA Response(\>=50%)|Cochran-Mantel-Haenszel|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Confirmed PSA Response(\>=50%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.032
71095186|NCT00699751|141698639|SUPERIORITY_OR_OTHER||||||<|0.001||||||\>=30% reduction in blood level|Cochran-Mantel-Haenszel|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=30% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
71095187|NCT00699751|141698639|SUPERIORITY_OR_OTHER|||||||0.002||||||\>=50% reduction in blood level|Cochran-Mantel-Haenszel|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=50% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.002
71095188|NCT00699751|141698639|SUPERIORITY_OR_OTHER|||||||0.005||||||Confirmed PSA Response(\>=50%)|Cochran-Mantel-Haenszel|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Confirmed PSA Response(\>=50%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.005
71095189|NCT00699751|141698640|SUPERIORITY_OR_OTHER|||||||0.16||||||Percentage change from baseline in PSA at Week 12|ANCOVA|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Percentage change from baseline in PSA at Week 12, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.160
71154196|NCT03100149|141801027|SUPERIORITY||Odds Ratio (OR)|0.76||||0.4063|TWO_SIDED|80.0|0.49|1.16||Nominal p-values are displayed for descriptive purposes only.|Regression, Logistic|||||1.16|0.49|0.4063
71095190|NCT00699751|141698641|SUPERIORITY_OR_OTHER|||||||0.004||||||Maximum Percentage Decrease from Baseline up to Week 12|ANCOVA|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Maximum Percentage Decrease from Baseline up to Week 12, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.004
71095191|NCT00699751|141698642|SUPERIORITY_OR_OTHER|||||||0.009||||||Percentage change from baseline in PSA at EOT|ANCOVA|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Percentage change from baseline in PSA at EOT, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.009
71095192|NCT00699751|141698643|SUPERIORITY_OR_OTHER||||||<|0.001||||||Maximum Percentage Decrease from Baseline in PSA response During the 24 Week Treatment Period|ANCOVA|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Maximum Percentage Decrease from Baseline in PSA response During the 24 Week Treatment Period, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
71095193|NCT00699751|141698644|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.657||||0.00012|TWO_SIDED|95.0|0.529|0.814||Time to first Skeletal Related Event (SRE)|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of time to first SRE, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists||0.814|0.529|0.00012
71095194|NCT00699751|141698645|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.639||||8e-05|TWO_SIDED|95.0|0.511|0.8||Time to External Beam Radiotherapy|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of time to EBRT, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists||0.8|0.511|0.00008
71154197|NCT03100149|141801028|SUPERIORITY||Odds Ratio (OR)|0.75||||0.3847|TWO_SIDED|80.0|0.48|1.15||Nominal p-values are displayed for descriptive purposes only.|Regression, Logistic|||||1.15|0.48|0.3847
71154198|NCT03100149|141801028|SUPERIORITY||Odds Ratio (OR)|0.88||||0.7055|TWO_SIDED|80.0|0.57|1.36||Nominal p-values are displayed for descriptive purposes only.|Regression, Logistic|||||1.36|0.57|0.7055
71154199|NCT03100149|141801029|SUPERIORITY||Difference in Adjusted Means|-0.73|STANDARD_ERROR_OF_MEAN|0.888||0.4142|TWO_SIDED|80.0|-1.87|0.41||Nominal p-values are displayed for descriptive purposes only.|ANCOVA|||||0.41|-1.87|0.4142
71033218|NCT00777023|141576395|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.61|STANDARD_ERROR_OF_MEAN|0.53||0.0024|TWO_SIDED|97.5|-2.8|-0.42||P value for pairwise test of difference of least square mean change from baseline between G-ER 1200 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at SDW 4||-0.42|-2.80|0.0024
71033219|NCT00777023|141576395|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.51|STANDARD_ERROR_OF_MEAN|0.52||0.004|TWO_SIDED|97.5|-2.69|-0.33||P value for pairwise test of difference of least square mean change from baseline between G-ER 1800 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at SDW 4||-0.33|-2.69|0.0040
71033220|NCT00777023|141576396|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.56|STANDARD_ERROR_OF_MEAN|0.51||0.0024|TWO_SIDED|97.5|-2.72|-0.41||P value for pairwise test of difference of least square mean change from baseline between G-ER 1200 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at SDW 12||-0.41|-2.72|0.0024
71154200|NCT03100149|141801029|SUPERIORITY||Difference in Adjusted Means|-0.67|STANDARD_ERROR_OF_MEAN|0.885||0.4486|TWO_SIDED|80.0|-1.81|0.47||Nominal p-values are displayed for descriptive purposes only.|ANCOVA|||||0.47|-1.81|0.4486
70921458|NCT04714320|141333624|SUPERIORITY||||||=|0.711||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 120||||=0.711
71033221|NCT00777023|141576396|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.12|STANDARD_ERROR_OF_MEAN|0.51||0.0281|TWO_SIDED|97.5|-2.26|0.02||P value for pairwise test of difference of least square mean change from baseline between G-ER 1800 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at SDW 12||0.02|-2.26|0.0281
71033222|NCT00777023|141576397|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.08||0.0608|TWO_SIDED|97.5|-0.32|-0.03||P value for pairwise test of difference of least square mean change from baseline between G-ER 1200 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at SDW 4||-0.03|-0.32|0.0608
71033223|NCT00777023|141576397|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|0.08||0.0003|TWO_SIDED|97.5|-0.45|-0.11||P value for pairwise test of difference of least square mean change from baseline between G-ER 1800 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at SDW 4||-0.11|-0.45|0.0003
71033224|NCT00777023|141576398|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.1||0.028|TWO_SIDED|97.5|-0.43|0.0||P value for pairwise test of difference of least square mean change from baseline between G-ER 1200 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at SDW 12||0.00|-0.43|0.0280
71033225|NCT00777023|141576398|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.1||0.0026|TWO_SIDED|97.5|-0.51|-0.07||P value for pairwise test of difference of least square mean change from baseline between G-ER 1800 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at SDW 12||-0.07|-0.51|0.0026
71033226|NCT03123094|141576400|OTHER||Slope|0.9533|STANDARD_ERROR_OF_MEAN|0.0803|||TWO_SIDED|95.0|0.781|1.1256|||||Standard error of mean is actually standard error of slope.|Dose proportionality was explored using the power model. Dose proportionality of spesolimab was to be assessed based on the exposure parameter AUC0-∞, determined for the 3 intravenous dose levels (perfect dose proportionality would correspond to a slope of 1).||1.1256|0.7810|
71033227|NCT03123094|141576401|OTHER||Slope|1.0014|STANDARD_ERROR_OF_MEAN|0.0568|||TWO_SIDED|95.0|0.8809|1.1219|||||Standard error of mean is actually standard error of slope.|Dose proportionality was explored using the power model. Dose proportionality of spesolimab was to be assessed based on the exposure parameter Cmax, determined for the 3 intravenous dose levels (perfect dose proportionality would correspond to a slope of 1).||1.1219|0.8809|
71033228|NCT03181594|141576450|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||The null hypothesis was that the mean change from baseline for the rTNSS would be 0 (no effect). Assumptions included an alpha level of 0.5 (2-tailed), 90% power, and a standard deviation of 2.5 for the mean change from baseline. A total of 68 participants was deemed adequate to test the hypothesis.||||<0.001
71033229|NCT03181594|141576452|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71033230|NCT03181594|141576453|SUPERIORITY||||||<|0.001||||||p\<0.001 at all time periods. p\<0.05 was considered statistically significant.|Wilcoxon signed rank|||||||<0.001
71033231|NCT00968812|141576460|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation: assuming a difference between canagliflozin and glimepiride of 0.0% and a common standard deviation of 1.0%, and using a 2-sample, 1-sided t-test with a Type I error rate of 0.0125, and assuming a drop-out rate of 35% in 52 weeks, it was estimated that approximately 427 patients per group would provide 90% power to demonstrate non-inferiority with the non-inferiority margin of 0.3, comparing canagliflozin with glimepiride.|Least-Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.109|0.085|||ANCOVA|||If the hypothesis of non-inferiority of canagliflozin to glimepiride at Week 52 was demonstrated (ie, upper bound of the 95% Confidence Interval of the treatment difference \[canagliflozin minus glimepiride\] was less than 0.3) and the upper bound was less than 0.0, the superiority of the canagliflozin dose relative to glimepiride would be concluded.||0.085|-0.109|
71154201|NCT03100149|141801030|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.3769|TWO_SIDED|80.0|0.94|1.42||Nominal p-values are displayed for descriptive purposes only.|Regression, Cox|||||1.42|0.94|0.3769
71154202|NCT03100149|141801030|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.1658|TWO_SIDED|80.0|1.02|1.53||Nominal p-values are displayed for descriptive purposes only.|Regression, Cox|||||1.53|1.02|0.1658
71095195|NCT00699751|141698646|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.344||||0.00191|TWO_SIDED|95.0|0.17|0.695||stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Receiving Radio-isotope, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists||0.695|0.17|0.00191
70921459|NCT04714320|141333624|SUPERIORITY||||||=|0.514||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 120||||=0.514
70921460|NCT04714320|141333624|SUPERIORITY||||||=|0.479||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 148||||=0.479
70921461|NCT04714320|141333624|SUPERIORITY||||||=|0.292||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 148||||=0.292
70921462|NCT04714320|141333624|SUPERIORITY||||||=|0.528||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 169||||=0.528
70921463|NCT04714320|141333624|SUPERIORITY||||||=|0.946||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 169||||=0.946
70921464|NCT04714320|141333624|SUPERIORITY||||||=|0.552||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 8||||=0.552
70974217|NCT00662792|141455429|NON_INFERIORITY|The non-inferiority margin for FEV1 endpoints was defined as d=0.050 L.|Difference of adjusted means|0.064|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.036|0.093|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (Salm50DPI)|H1: Non-Inferiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Salmeterol (Salm50DPI) for FEV1AUC12-24||0.093|0.036|<.0001
70974218|NCT00662792|141455429|NON_INFERIORITY|The non-inferiority margin for FEV1 endpoints was defined as d=0.050 L.|Difference of adjusted means|0.064|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.036|0.093|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (Tio18GEL)|H1: Non-inferiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Tiotropium (TIO18GEL) of FEV1AUC12-24||0.093|0.036|<.0001
70974219|NCT00662792|141455429|OTHER||Difference of adjusted means|-0.057|STANDARD_ERROR_OF_MEAN|0.015||0.0001|TWO_SIDED|95.0|-0.086|-0.028|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (T18GEL+S-DPI)|The Tiotropium free combination (T18GEL+S\_DPI) was included in order to characterise this treatment in comparison with the FDC Tiotropium/Salmeterol (T+S\_PE). No formal hypotheses were defined.||-0.028|-0.086|0.0001
70974220|NCT00662792|141455430|SUPERIORITY||Difference of adjusted means|0.134|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001|TWO_SIDED|95.0|0.102|0.166|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (Salm50DPI)|H1: Superiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Salmeterol (Salm50DPI) of Peak FEV1||0.166|0.102|<.0001
70974221|NCT00662792|141455430|SUPERIORITY||Difference of adjusted means|0.066|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001|TWO_SIDED|95.0|0.034|0.098|||ANOVA|Analysis of with terms for centre, patient with centre, treatment, and period. α = 0.025 one-sided|(T+S\_PE) - (Tio18GEL)|H1: Superiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Tiotropium (TIO18GEL) of PeakFEV1.||0.098|0.034|<.0001
70974222|NCT00662792|141455430|OTHER||Difference of adjusted means|-0.026|STANDARD_ERROR_OF_MEAN|0.016||0.1093|TWO_SIDED|95.0|-0.058|0.006|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (T18GEL+S\_DPI)|The Tiotropium free combination (T18GEL+S\_DPI) was included in order to characterise this treatment in comparison with the FDC Tiotropium/Salmeterol (T+S\_PE). No formal hypotheses were defined.||0.006|-0.058|0.1093
70974223|NCT00662792|141455431|NON_INFERIORITY|The non-inferiority margin for FEV1 endpoints was defined as d=0.050 L.|Differences of adjusted means|0.058|STANDARD_ERROR_OF_MEAN|0.017||0.0008|TWO_SIDED|95.0|0.024|0.092|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (Salm50DPI)|H1: Non-inferiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Salmeterol (Salm50DPI) of trough FEV1||0.092|0.024|0.0008
70921465|NCT04714320|141333624|SUPERIORITY||||||=|0.598||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 8||||=0.598
70974224|NCT00662792|141455431|NON_INFERIORITY|The non-inferiority margin for FEV1 endpoints was defined as a delta of 0.050 L.|Difference of adjusted means|0.029|STANDARD_ERROR_OF_MEAN|0.017||0.0857|TWO_SIDED|95.0|-0.004|0.063|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (Tio18GEL)|H1: Non-inferiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Tiotropium (TIO18GEL) of trough FEV1||0.063|-0.004|0.0857
71154203|NCT03100149|141801031|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9542|TWO_SIDED|80.0|0.77|1.33||Nominal p-values are displayed for descriptive purposes only.|Regression, Cox|||||1.33|0.77|0.9542
71154204|NCT03100149|141801031|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.4567|TWO_SIDED|80.0|0.63|1.13||Nominal p-values are displayed for descriptive purposes only.|Regression, Cox|||||1.13|0.63|0.4567
70974225|NCT00662792|141455431|OTHER||Difference of adjusted means|-0.037|STANDARD_ERROR_OF_MEAN|0.017||0.0317|TWO_SIDED|95.0|-0.071|-0.003|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (T18GEL+S-DPI)|The Tiotropium free combination (T18GEL+S\_DPI) was included in order to characterise this treatment in comparison with the FDC Tiotropium/Salmeterol (T+S\_PE). No formal hypotheses were defined.||-0.003|-0.071|0.0317
70974226|NCT00662792|141455432|SUPERIORITY||Difference of adjusted means|0.097|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.071|0.124|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided|(T+S\_PE) - (Salm50DPI)|H1: Superiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. salmeterol (Salm50DPI) for FEV1 AUC0-24||0.124|0.071|<.0001
70974227|NCT00662792|141455432|SUPERIORITY||Difference of adjusted mean difference|0.067|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.041|0.093|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided|(T+S\_PE) - (Tio18GEL)|H1: Superiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Tiotropium (TIO18GEL) for FEV1 AUC24||0.093|0.041|<.0001
70974228|NCT00662792|141455432|SUPERIORITY||Difference of adjusted means|-0.041|STANDARD_ERROR_OF_MEAN|0.014||0.0029|TWO_SIDED|95.0|-0.067|-0.014|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided|(T+S\_PE) - (T18GEL+S-DPI)|||-0.014|-0.067|0.0029
70974229|NCT00662792|141455433|SUPERIORITY||Difference of adjusted means|0.083|STANDARD_ERROR_OF_MEAN|0.025||0.001|TWO_SIDED|95.0|0.034|0.132|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided|(T+S\_PE) - (Tio18GEL)|||0.132|0.034|0.0010
70974230|NCT00662792|141455433|SUPERIORITY||Difference of adjusted means|0.176|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.127|0.226|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.226|0.127|<.0001
70974231|NCT00662792|141455433|SUPERIORITY||Difference of adjusted means|-0.045|STANDARD_ERROR_OF_MEAN|0.025||0.0757|TWO_SIDED|95.0|-0.095|0.005|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.005|-0.095|0.0757
70974232|NCT00662792|141455434|SUPERIORITY||Difference of adjusted means|0.085|STANDARD_ERROR_OF_MEAN|0.027||0.0015|TWO_SIDED|95.0|0.033|0.137|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.137|0.033|0.0015
70974233|NCT00662792|141455434|SUPERIORITY||Difference of adjusted means|0.118|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.066|0.171|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.171|0.066|<.0001
70974234|NCT00662792|141455434|SUPERIORITY||Difference of adjusted means|-0.085|STANDARD_ERROR_OF_MEAN|0.027||0.0017|TWO_SIDED|95.0|-0.138|-0.032|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||-0.032|-0.138|0.0017
70974235|NCT00662792|141455435|SUPERIORITY||Difference of adjusted means|0.084|STANDARD_ERROR_OF_MEAN|0.024||0.0005|TWO_SIDED|95.0|0.037|0.131|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.131|0.037|0.0005
70974236|NCT00662792|141455435|SUPERIORITY||Difference of adjusted means|0.147|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.1|0.194|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.194|0.100|<.0001
70974237|NCT00662792|141455435|SUPERIORITY||Difference of adjusted means|-0.065|STANDARD_ERROR_OF_MEAN|0.024||0.0074|TWO_SIDED|95.0|-0.113|-0.018|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||-0.018|-0.113|0.0074
70974238|NCT00662792|141455436|SUPERIORITY||Differences of adjusted means|0.051|STANDARD_ERROR_OF_MEAN|0.03||0.0898|TWO_SIDED|95.0|-0.008|0.109|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.109|-0.008|0.0898
70974239|NCT00662792|141455436|SUPERIORITY||Difference of adjusted means|0.142|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.083|0.201|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.201|0.083|<.0001
70974240|NCT00662792|141455436|SUPERIORITY||Difference of adjusted means|-0.057|STANDARD_ERROR_OF_MEAN|0.03||0.0601|TWO_SIDED|95.0|-0.116|0.002|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.002|-0.116|0.0601
70974241|NCT00662792|141455437|SUPERIORITY||Difference of adjusted means|-0.028|STANDARD_ERROR_OF_MEAN|0.031||0.3652|TWO_SIDED|95.0|-0.089|0.033|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.033|-0.089|0.3652
70974242|NCT00662792|141455437|SUPERIORITY||Difference of adjusted means|0.042|STANDARD_ERROR_OF_MEAN|0.031||0.1816|TWO_SIDED|95.0|-0.02|0.103|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.103|-0.020|0.1816
70974243|NCT00662792|141455437|SUPERIORITY||Difference of adjusted means|-0.095|STANDARD_ERROR_OF_MEAN|0.031||0.0026|TWO_SIDED|95.0|-0.157|-0.033|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||-0.033|-0.157|0.0026
70974244|NCT00662792|141455438|SUPERIORITY||Difference of adjusted means|11.8|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|6.9|16.8|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||16.8|6.9|<.0001
70974245|NCT00662792|141455438|SUPERIORITY||Difference of adjusted means|24.2|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|19.2|29.2|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||29.2|19.2|<.0001
70974246|NCT00662792|141455438|SUPERIORITY||Difference of adjusted means|-3.4|STANDARD_ERROR_OF_MEAN|2.6||0.1804|TWO_SIDED|95.0|-8.5|1.6|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||1.6|-8.5|0.1804
70974247|NCT00662792|141455439|SUPERIORITY||Difference of adjusted means|8.5|STANDARD_ERROR_OF_MEAN|2.5||0.0008|TWO_SIDED|95.0|3.5|13.4|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||13.4|3.5|0.0008
70974248|NCT00662792|141455439|SUPERIORITY||Difference of adjusted means|10.6|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|5.6|15.5|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||15.5|5.6|<.0001
70974249|NCT00662792|141455439|SUPERIORITY||Difference of adjusted means|-12.9|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-17.9|-8.0|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S\_DPI)|||-8.0|-17.9|<.0001
70974250|NCT00662792|141455440|SUPERIORITY||Difference of adjusted means|10.1|STANDARD_ERROR_OF_MEAN|2.3|<|0.0001|TWO_SIDED|95.0|5.7|14.6|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||14.6|5.7|<.0001
70974251|NCT00662792|141455440|SUPERIORITY||Difference of adjusted means|17.4|STANDARD_ERROR_OF_MEAN|2.3|<|0.0001|TWO_SIDED|95.0|12.9|21.9|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||21.9|12.9|<.0001
71033232|NCT00968812|141576460|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation: assuming a difference between canagliflozin and glimepiride of 0.0% and a common standard deviation of 1.0%, and using a 2-sample, 1-sided t-test with a Type I error rate of 0.0125, and assuming a drop-out rate of 35% in 52 weeks, it was estimated that approximately 427 patients per group would provide 90% power to demonstrate non-inferiority with the non-inferiority margin of 0.3, comparing canagliflozin with glimepiride|Least-Squares Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.217|-0.023|||ANCOVA|||If the hypothesis of non-inferiority of canagliflozin to glimepiride at Week 52 was demonstrated (ie, upper bound of the 95% Confidence Interval of the treatment difference \[canagliflozin minus glimepiride\] was less than 0.3) and the upper bound was less than 0.0, the superiority of the canagliflozin dose relative to glimepiride would be concluded.||-0.023|-0.217|
71033233|NCT00968812|141576461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1|||<|0.001|TWO_SIDED|95.0|0.06|0.16|||Regression, Logistic|||||0.16|0.06|<0.001
71033234|NCT00968812|141576461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.09|||<|0.001|TWO_SIDED|95.0|0.05|0.14|||Regression, Logistic|||||0.14|0.05|<0.001
71033235|NCT00968812|141576462|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-5.7|-4.7|||ANCOVA|||||-4.7|-5.7|<0.001
71033236|NCT00968812|141576462|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-6.2|-5.1|||ANCOVA|||||-5.1|-6.2|<0.001
71033237|NCT00968812|141576463|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|95.0|-0.2|0.01|||ANCOVA|||||0.010|-0.200|
71033238|NCT00968812|141576463|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|95.0|-0.289|-0.078|||ANCOVA|||||-0.078|-0.289|
71033239|NCT01593852|141576465|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical dose observations, a sample size of 68 patients per study group (i.e. 62 evaluable patients for 10% dropout rate) for a total of 136 patient randomized will allow for 80% power to detect for approximately 40% reduction in dose area product (DAP). This sample size will allow for detection of approximately 40% reduction in air kerma (AK). No adjustment for multiple endpoints was performed as both endpoints are assessing radiation dose.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71033240|NCT01593852|141576473|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical dose observations, a sample size of 68 patients per study group (i.e. 62 evaluable patients for 10% dropout rate) for a total of 136 patient randomized will allow for 80% power to detect for approximately 40% reduction in dose area product (DAP). This sample size will allow for detection of approximately 40% reduction in air kerma (AK). No adjustment for multiple endpoints was performed as both endpoints are assessing radiation dose.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71033241|NCT02937870|141576494|OTHER||Least square (LS) mean difference|0.66||||0.177|TWO_SIDED|95.0|-0.14|1.47||p-values for treatment comparison of test adhesive 1 vs. no adhesive were adjusted using the Dunnett's method.|ANCOVA|ANCOVA with factors for subject (random effect), period \& treatment, subject-level and period-level pre-treatment baseline bite force as covariate.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||1.47|-0.14|0.1770
71033242|NCT02937870|141576495|OTHER||LS mean difference|-0.2||||0.8321|TWO_SIDED|95.0|-0.98|0.59||p-values for treatment comparison of test adhesive 1 vs. no adhesive were adjusted using the Dunnett's method.|ANCOVA|ANCOVA with factors for subject (random effect), period \& treatment, subject-level and period-level pre-treatment baseline bite force as covariate.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||0.59|-0.98|0.8321
71033243|NCT02937870|141576496|OTHER||LS mean difference|0.07||||0.8566|TWO_SIDED|95.0|-0.72|0.87|||ANCOVA|ANCOVA with factors for subject (random effect), period \& treatment, subject-level and period-level pre-treatment baseline bite force as covariate.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||0.87|-0.72|0.8566
71033244|NCT02937870|141576497|OTHER||LS mean difference|-0.79||||0.0488|TWO_SIDED|95.0|-1.58|0.0|||ANCOVA|ANCOVA with factors for subject (random effect), period \& treatment, subject-level and period-level pre-treatment baseline bite force as covariate.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||-0.00|-1.58|0.0488
71033245|NCT02937870|141576498|OTHER||LS mean difference|0.86||||0.0352|TWO_SIDED|95.0|0.06|1.66|||ANCOVA|ANCOVA with factors for subject (random effect), period \& treatment, subject-level and period-level pre-treatment baseline bite force as covariate.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||1.66|0.06|0.0352
71033246|NCT00609674|141576509|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANCOVA|||||||0.004
71033247|NCT00571064|141576535|SUPERIORITY_OR_OTHER|||||||0.6593|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 6 (Visit 3)||||0.6593
71033248|NCT00571064|141576535|SUPERIORITY_OR_OTHER|||||||0.6048|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12/ET (Visit 4)||||0.6048
71154205|NCT01754597|141801066|SUPERIORITY|||||||0.714|||||||Wilcoxon (Mann-Whitney)|||||||0.714
71154206|NCT01754597|141801067|SUPERIORITY|||||||0.492|||||||Wilcoxon (Mann-Whitney)|||||||0.492
71154207|NCT01754597|141801068|SUPERIORITY|||||||0.183|||||||Wilcoxon (Mann-Whitney)|||||||0.183
70974252|NCT00662792|141455440|SUPERIORITY||Difference of adjusted means|-8.2|STANDARD_ERROR_OF_MEAN|2.3||0.0004|TWO_SIDED|95.0|-12.7|-3.7|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S\_DPI)|||-3.7|-12.7|0.0004
70974253|NCT00662792|141455441|SUPERIORITY||Difference of adjusted means|13.1|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|7.2|18.9|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||18.9|7.2|<.0001
70974254|NCT00662792|141455441|SUPERIORITY||Difference of adjusted means|23.1|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|17.2|28.9|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||28.9|17.2|<.0001
70974255|NCT00662792|141455441|SUPERIORITY||Difference in adjusted means|-5.3|STANDARD_ERROR_OF_MEAN|3.0||0.0769|TWO_SIDED|95.0|-11.2|0.6|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.6|-11.2|0.0769
70974256|NCT00662792|141455442|SUPERIORITY||Difference of adjusted means|2.8|STANDARD_ERROR_OF_MEAN|3.2||0.3775|TWO_SIDED|95.0|-3.5|9.1|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||9.1|-3.5|0.3775
70974257|NCT00662792|141455442|SUPERIORITY||Difference of adjusted means|7.1|STANDARD_ERROR_OF_MEAN|3.2||0.0285|TWO_SIDED|95.0|0.7|13.4|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||13.4|0.7|0.0285
70974258|NCT00662792|141455442|SUPERIORITY||Difference of adjusted means|-8.9|STANDARD_ERROR_OF_MEAN|3.2||0.0065|TWO_SIDED|95.0|-15.2|-2.5|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||-2.5|-15.2|0.0065
70974259|NCT00662792|141455446|SUPERIORITY||Difference of adjusted means|5.7|STANDARD_ERROR_OF_MEAN|2.4||0.0182|TWO_SIDED|95.0|1.0|10.4|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Morning PEF||10.4|1.0|0.0182
71095196|NCT00699751|141698647|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.847||||0.53277|TWO_SIDED|95.0|0.504|1.426||Time to Pathological Bone Fracture|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Pathological Bone Fracture, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists||1.426|0.504|0.53277
71154208|NCT01588236|141801069|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED|95.0||||p value for multiple comparison among 3 arms and comparison between investigational drug and placebo|Mixed Models Analysis|||||||>0.05
70974260|NCT00662792|141455446|SUPERIORITY||Difference of adjusted means|6.3|STANDARD_ERROR_OF_MEAN|2.4||0.0091|TWO_SIDED|95.0|1.6|11.1|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Morning PEF||11.1|1.6|0.0091
70974261|NCT00662792|141455446|SUPERIORITY||Difference of adjusted means|-8.0|STANDARD_ERROR_OF_MEAN|2.4||0.001|TWO_SIDED|95.0|-12.8|-3.3|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Morning PEF||-3.3|-12.8|0.0010
70974262|NCT00662792|141455446|SUPERIORITY||Difference of adjusted means|11.0|STANDARD_ERROR_OF_MEAN|2.6|<|0.0001|TWO_SIDED|95.0|5.8|16.2|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Evening PEF||16.2|5.8|<.0001
70974263|NCT00662792|141455446|SUPERIORITY||Difference of adjusted means|23.3|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|95.0|18.1|28.6|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Evening PEF||28.6|18.1|<.0001
70974264|NCT00662792|141455446|SUPERIORITY||Difference of adjusted means|1.5|STANDARD_ERROR_OF_MEAN|2.7||0.5766|TWO_SIDED|95.0|-3.8|6.8|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Evening PEF||6.8|-3.8|0.5766
70974265|NCT00662792|141455447|SUPERIORITY||Difference of adjusted means|0.04|STANDARD_ERROR_OF_MEAN|0.016||0.0137|TWO_SIDED|95.0|0.008|0.071|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Morning FEV1||0.071|0.008|0.0137
70974266|NCT00662792|141455447|SUPERIORITY||Difference of adjusted means|0.027|STANDARD_ERROR_OF_MEAN|0.016||0.0981|TWO_SIDED|95.0|-0.005|0.059|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Morning FEV1||0.059|-0.005|0.0981
70974267|NCT00662792|141455447|SUPERIORITY||Difference of adjusted means|-0.022|STANDARD_ERROR_OF_MEAN|0.016||0.1827|TWO_SIDED|95.0|-0.054|0.01|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Morning FEV1||0.010|-0.054|0.1827
70974268|NCT00662792|141455447|SUPERIORITY||Difference of adjusted means|0.057|STANDARD_ERROR_OF_MEAN|0.018||0.0014|TWO_SIDED|95.0|0.022|0.092|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Evening FEV1||0.092|0.022|0.0014
70974269|NCT00662792|141455447|SUPERIORITY||Difference of adjusted means|0.105|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.07|0.14|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Evening FEV1||0.140|0.070|<.0001
70974270|NCT00662792|141455447|SUPERIORITY||Difference of adjusted means|0.02|STANDARD_ERROR_OF_MEAN|0.018||0.2584|TWO_SIDED|95.0|-0.015|0.056|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Evening FEV1||0.056|-0.015|0.2584
71154209|NCT01588236|141801070|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||p value for multiple comparison among 3 arms and comparison between investigational drug and placebo||||>0.05
71154210|NCT01588236|141801071|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED|95.0||||p value for comparison between overall drug group vs placebo, and between high dose vs placebo|Mixed Models Analysis|||||||<0.01
70974271|NCT00662792|141455448|SUPERIORITY||Difference of adjusted means|-0.07|STANDARD_ERROR_OF_MEAN|0.02||0.0027|TWO_SIDED|95.0|-0.11|-0.02|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Daytime||-0.02|-0.11|0.0027
70974272|NCT00662792|141455448|SUPERIORITY||Difference of adjusted means|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.4587|TWO_SIDED|95.0|-0.06|0.03|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Daytime||0.03|-0.06|0.4587
70974273|NCT00662792|141455448|SUPERIORITY||Difference of adjusted means|0.03|STANDARD_ERROR_OF_MEAN|0.02||0.1535|TWO_SIDED|95.0|-0.01|0.08|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Daytime||0.08|-0.01|0.1535
70974274|NCT00662792|141455448|SUPERIORITY||Difference of adjusted means|-0.09|STANDARD_ERROR_OF_MEAN|0.02||0.0002|TWO_SIDED|95.0|-0.14|-0.05|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Night-time||-0.05|-0.14|0.0002
71033249|NCT00571064|141576535|SUPERIORITY_OR_OTHER|||||||0.5924|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12 LOCF (Study Endpoint)||||0.5924
71033250|NCT00571064|141576536|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Significance level 0.05|t-test, 2 sided|||Week 6 (Visit 3)||||<0.0001
71033251|NCT00571064|141576536|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12/ET (Visit 4)||||<0.0001
71033252|NCT00571064|141576536|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12 LOCF (Study Endpoint)||||<0.0001
70974275|NCT00662792|141455448|SUPERIORITY||Difference of adjusted means|-0.09|STANDARD_ERROR_OF_MEAN|0.03||0.0006|TWO_SIDED|95.0|-0.14|-0.04|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Night-time||-0.04|-0.14|0.0006
71033253|NCT00571064|141576538|SUPERIORITY_OR_OTHER|||||||0.0431|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12/ET (Visit 4)||||0.0431
71033254|NCT00571064|141576538|SUPERIORITY_OR_OTHER|||||||0.0431|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12 LOCF (Study Endpoint)||||0.0431
71095197|NCT00699751|141698648|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.949||||0.89567|TWO_SIDED|95.0|0.435|2.07||Time to Surgical Intervention|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Surgical Intervention, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists||2.07|0.435|0.89567
70974276|NCT00662792|141455448|SUPERIORITY||Difference of adjusted means|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.5784|TWO_SIDED|95.0|-0.06|0.04|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Night-time||0.04|-0.06|0.5784
70974277|NCT00662792|141455448|SUPERIORITY||Difference of adjusted means|-0.09|STANDARD_ERROR_OF_MEAN|0.02||0.0003|TWO_SIDED|95.0|-0.14|-0.04|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|24 hours||-0.04|-0.14|0.0003
70974278|NCT00662792|141455448|SUPERIORITY||Difference of adjusted means|-0.07|STANDARD_ERROR_OF_MEAN|0.02||0.0042|TWO_SIDED|95.0|-0.12|-0.02|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|24 hours||-0.02|-0.12|0.0042
70974279|NCT00662792|141455448|SUPERIORITY||Difference of adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.9978|TWO_SIDED|95.0|-0.05|0.05|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|24 hours||0.05|-0.05|0.9978
70974280|NCT00662792|141455449|SUPERIORITY||Difference of adjusted means|-0.33|STANDARD_ERROR_OF_MEAN|0.11||0.0029|TWO_SIDED|95.0|-0.55|-0.11|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Daytime||-0.11|-0.55|0.0029
70974281|NCT00662792|141455449|SUPERIORITY||Difference of adjusted means|-0.36|STANDARD_ERROR_OF_MEAN|0.11||0.0012|TWO_SIDED|95.0|-0.58|-0.14|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Daytime||-0.14|-0.58|0.0012
70974282|NCT00662792|141455449|SUPERIORITY||Difference of adjusted means|0.12|STANDARD_ERROR_OF_MEAN|0.07||0.0829|TWO_SIDED|95.0|-0.02|0.25|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Daytime||0.25|-0.02|0.0829
71033255|NCT00571064|141576540|SUPERIORITY_OR_OTHER|||||||0.1285|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12/ET (Visit 4)||||0.1285
71033256|NCT00571064|141576540|SUPERIORITY_OR_OTHER|||||||0.1285|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12 LOCF (Study Endpoint)||||0.1285
71033257|NCT00571064|141576542|SUPERIORITY_OR_OTHER|||||||0.2327|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 6 (Visit 3)||||0.2327
71033258|NCT00571064|141576542|SUPERIORITY_OR_OTHER|||||||0.4724|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12/ET (Visit 4)||||0.4724
71033259|NCT00571064|141576542|SUPERIORITY_OR_OTHER|||||||0.4724|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12 LOCF - Study Endpoint||||0.4724
71033260|NCT00244764|141576543|SUPERIORITY_OR_OTHER||percentage|34.7||||||95.0|28.4|40.9|||||The estimated value provided is the response rate.|||40.9|28.4|
71033261|NCT00244764|141576544|SUPERIORITY_OR_OTHER||percentage|42.0||||||95.0|29.0|54.0|||||The estimated value is the percentage of the first 60 participants who had stable disease at Week 12, as assessed by the investigator.|||54|29|
71033262|NCT00840073|141576563|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|96.0||||||90.0|85.13|108.27|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||108.27|85.13|
71033263|NCT00840073|141576564|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|103.81||||||90.0|96.72|111.41|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111.41|96.72|
71154211|NCT01588236|141801072|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|95.0||||p value for comparison between overall drug group vs placebo, and between low dose vs placebo|Mixed Models Analysis|||||||<0.05
71095198|NCT00699751|141698649|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.14486|TWO_SIDED|95.0|0.404|1.145||Time to Spinal Cord Compression|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Spinal Cord Compression, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||1.145|0.404|0.14486
71095199|NCT00699751|141698650|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.727||||0.00932|TWO_SIDED|95.0|0.571|0.925||Time to Other Cancer Treatment|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Other Cancer Treatment, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||0.925|0.571|0.00932
71095200|NCT00699751|141698651|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.00187|TWO_SIDED|95.0|0.546|0.873||Time to Marked Deterioration of ECOG PS|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Marked Deterioration of ECOG PS, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||0.873|0.546|0.00187
71095201|NCT01257438|141698668|SUPERIORITY_OR_OTHER||Greenwood's estimate of variance|0.59|||<|0.001|TWO_SIDED|95.0|0.44|0.79|||Log Rank|||Subjects at risk (at 6 months) is a calculation in Kaplan-Meier time-to-event analyses that refers to subjects who have not had ACPP failure through the 6 months (i.e., are event-free through 6 months).||0.79|0.44|<0.001
71095202|NCT01257438|141698669|NON_INFERIORITY_OR_EQUIVALENCE|The p-value is based on a non-inferiority Farrington and Manning Exact Test. The non-inferiority margin is 0.075 (or 7.5%).||||||0.007|TWO_SIDED||||||Farrington and Manning Exact Test|The non-inferiority margin is 0.075 (or 7.5%)||||||0.007
71095203|NCT04180696|141698707|SUPERIORITY|Endpoint for statistical analysis is the proportion Improved.||||||0.61|||||||Chi-squared|||||||0.61
71095204|NCT04180696|141698708|SUPERIORITY||Odds Ratio (OR)|1.192|STANDARD_ERROR_OF_MEAN|0.367||0.63|TWO_SIDED|95.0|0.579|2.455|||Regression, Logistic|Proportional odds logistic regression model. Baseline NYHA class and time included as fixed covariates.||Due to limited number of subjects with NYHA class III or IV during follow-up, class III, IV, and death were grouped as a single category for analysis.||2.455|0.579|0.63
71095205|NCT04180696|141698709|SUPERIORITY||Hazard Ratio (HR)|1.25|STANDARD_ERROR_OF_MEAN|0.476||0.64|TWO_SIDED|95.0|0.492|3.175|||Regression, Cox|Adjusted for NYHA class and sex.||||3.175|0.492|0.64
71095206|NCT04180696|141698710|SUPERIORITY|||||||0.78|||||||Log Rank|||||||0.78
71095207|NCT04180696|141698711|SUPERIORITY||Hazard Ratio (HR)|1.02|STANDARD_ERROR_OF_MEAN|0.817||0.98|TWO_SIDED|95.0|0.206|5.056|||Regression, Cox|||||5.056|0.206|0.98
70921466|NCT04714320|141333624|SUPERIORITY||||||=|0.184||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 15||||=0.184
70921467|NCT04714320|141333624|SUPERIORITY||||||=|0.614||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 15||||=0.614
70921468|NCT04714320|141333624|SUPERIORITY||||||=|0.933||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 22||||=0.933
70921469|NCT04714320|141333624|SUPERIORITY||||||=|0.803||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 22||||=0.803
70921470|NCT04714320|141333624|SUPERIORITY||||||=|0.686||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 29||||=0.686
70921471|NCT04714320|141333624|SUPERIORITY||||||=|0.752||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 29||||=0.752
71095208|NCT04739709|141698716|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71095209|NCT04739709|141698717|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71095210|NCT04739709|141698719|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71095211|NCT04739709|141698720|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71095212|NCT04739709|141698721|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71095213|NCT04739709|141698722|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71095214|NCT04739709|141698723|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71095215|NCT04739709|141698724|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71095216|NCT04739709|141698725|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71095217|NCT04739709|141698726|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71095218|NCT04739709|141698727|SUPERIORITY||Mean Difference (Net)|-1.6|||<|0.001|TWO_SIDED|95.0|-1.8|-1.3|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-1.3|-1.8|<0.001
71154212|NCT05785832|141801076|SUPERIORITY||Mean Difference (Net)|-0.6|||<|0.001|TWO_SIDED|95.0|-0.8|-0.4|||Regression, Linear|||Adjusted Difference Between Groups||-0.4|-0.8|<0.001
71095219|NCT04739709|141698728|SUPERIORITY||Mean Difference (Net)|-0.7|||<|0.001|TWO_SIDED|95.0|-0.9|-0.6|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.6|-0.9|<0.001
71095220|NCT04739709|141698729|SUPERIORITY||Mean Difference (Net)|-0.7|||<|0.001|TWO_SIDED|95.0|-0.8|-0.5|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.5|-0.8|<0.001
71095221|NCT04739709|141698730|SUPERIORITY||Mean Difference (Net)|-0.03||||0.017|TWO_SIDED|95.0|-0.06|-0.01|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.01|-0.06|0.017
71095222|NCT04739709|141698731|SUPERIORITY||Mean Difference (Net)|-0.07|||<|0.001|TWO_SIDED|95.0|-0.1|-0.04|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.04|-0.10|<0.001
71095223|NCT04739709|141698732|SUPERIORITY||Mean Difference (Net)|-0.09|||<|0.001|TWO_SIDED|95.0|-0.11|-0.06|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.06|-0.11|<0.001
71095224|NCT04739709|141698733|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71095225|NCT02184156|141698741|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
70974283|NCT00662792|141455449|SUPERIORITY||Difference of adjusted means|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.0115|TWO_SIDED|95.0|-0.3|-0.04|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Night-time||-0.04|-0.30|0.0115
70974284|NCT00662792|141455449|SUPERIORITY||Difference of adjusted means|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.1772|TWO_SIDED|95.0|-0.22|0.04|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Night-time||0.04|-0.22|0.1772
70974285|NCT00662792|141455449|SUPERIORITY||Difference of adjusted means|0.04|STANDARD_ERROR_OF_MEAN|0.11||0.6895|TWO_SIDED|95.0|-0.18|0.27|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Night-time||0.27|-0.18|0.6895
70974286|NCT00662792|141455449|SUPERIORITY||Difference of adjusted means|-0.52|STANDARD_ERROR_OF_MEAN|0.16||0.0013|TWO_SIDED|95.0|-0.84|-0.21|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Over 24 hours||-0.21|-0.84|0.0013
71095226|NCT02184156|141698742|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||0.25
71095227|NCT00002874|141698743|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.02|TWO_SIDED|95.0|0.59|0.98||One-sided significance level = 0.046 to preserve overall significance level of 0.05 for the study.|Log Rank||Stratifying variables were fixed covariates: prior hormone therapy (yes/no), entry prostate-specific antigen (PSA) (1.6-4.0 vs. 0.2-1.5), PSA nadir after surgery (\< 0.5 vs. \>= 0.5), positive surgical margins (yes/no). Reference level = placebo arm.|||0.98|0.59|0.020
71095228|NCT00002874|141698744|SUPERIORITY||Cox Proportional Hazard|1.1||||0.289|TWO_SIDED|95.0|0.79|1.53|||Gray's test|One-sided test|||Reference level = placebo arm|1.53|0.79|0.289
71154213|NCT05785832|141801077|SUPERIORITY||Mean Difference (Net)|14.0|||<|0.001|TWO_SIDED|95.0|11.0|17.0|||Regression, Linear|||Adjusted Difference Between Groups||17|11|<0.001
71154214|NCT05785832|141801078|SUPERIORITY||Mean Difference (Net)|-21.0|||<|0.001|TWO_SIDED|95.0|-26.0|-15.0|||Regression, Linear|||Adjusted Difference Between Groups||-15|-26|<0.001
71154215|NCT05785832|141801079|SUPERIORITY||Mean Difference (Net)|-14.0|||<|0.001|TWO_SIDED|95.0|-17.0|-11.0|||Regression, Linear|||Adjusted Difference Between Groups||-11|-17|<0.001
70974287|NCT00662792|141455449|SUPERIORITY||Difference of adjusted means|-0.47|STANDARD_ERROR_OF_MEAN|0.16||0.004|TWO_SIDED|95.0|-0.78|-0.15|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Over 24 hours||-0.15|-0.78|0.0040
70974288|NCT00662792|141455449|SUPERIORITY||Difference of adjusted means|0.16|STANDARD_ERROR_OF_MEAN|0.16||0.3287|TWO_SIDED|95.0|-0.16|0.48|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Over 24 hours||0.48|-0.16|0.3287
70974289|NCT00662792|141455450|SUPERIORITY||Difference of adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.9956|TWO_SIDED|95.0|-0.03|0.03|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.03|-0.03|0.9956
71095229|NCT00002874|141698745|SUPERIORITY||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|95.0|0.4|0.58|||Gray's test|One-sided test|Reference level = placebo arm|||0.58|0.40|<0.001
71095230|NCT00002874|141698746|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.213|TWO_SIDED|95.0|0.85|1.46|||Gray's test|One-sided test|Reference level = placebo arm|||1.46|0.85|0.213
71095231|NCT00002874|141698747|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71095232|NCT00002874|141698748|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.002|TWO_SIDED|95.0|0.46|0.87|||Gray's test|One-sided test|Reference level = placebo arm|||0.87|0.46|0.002
71095233|NCT00002874|141698749|SUPERIORITY||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.32|0.74|||Gray's test|One-sided test|Reference level = placebo arm|||0.74|0.32|<0.001
71095234|NCT00002874|141698750|SUPERIORITY||Cox Proportional Hazard|0.6|||<|0.001|TWO_SIDED|95.0|0.5|0.71|||Log Rank|One-side test|||Reference level = placebo arm|0.71|0.50|< 0.001
71095235|NCT00002874|141698751|SUPERIORITY|||||||0.06|||||||Chi-squared|||Acute radiotherapy toxicity||||0.060
71154216|NCT05785832|141801080|SUPERIORITY||Mean Difference (Net)|-9.1|||<|0.001|TWO_SIDED|95.0|-11.7|-6.6|||Regression, Linear|||Adjusted Difference Between Groups||-6.6|-11.7|<0.001
71154217|NCT05785832|141801081|SUPERIORITY||Mean Difference (Net)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.0|-0.4|||Regression, Linear|||Adjusted Difference Between Groups||-0.4|-1.0|<0.001
71154218|NCT05785832|141801082|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.4|0.1||A hierarchical procedure was used to control for the overall type I error. Since the P value for this outcome was more than 0.05, no additional P values are provided for subsequent secondary outcomes.|Regression, Linear|||Adjusted Difference Between Groups||0.1|-0.4|
71154219|NCT05785832|141801083|SUPERIORITY||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.09|0.04|||Regression, Linear|||Adjusted Difference Between Groups||0.04|-0.09|
71095236|NCT00002874|141698751|SUPERIORITY|||||||0.029|||||||Chi-squared|||Hormone therapy and late radiotherapy toxicity||||0.029
71095237|NCT03837938|141698752|NON_INFERIORITY|According to the protocol and SAP non-inferiority margin was defined as 20%.|Difference in rates Levopront®-Libexin®|5.81|||||ONE_SIDED|97.5|-7.17|||||||Difference in daytime resolved rates Levopront® (Test) vs Libexin® (Control) was reported|||-7.17|
71095238|NCT03837938|141698753|NON_INFERIORITY|According to the protocol and SAP non-inferiority margin was defined as 20%|difference in rates Levopront®-Libexin®|5.43|||||ONE_SIDED|97.5|-7.31|||||||Difference in daytime resolved rates Levopront® (Test) vs Libexin® (Control) was reported|||-7.31|
71095239|NCT03837938|141698754|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||>|0.999|||||||Fisher Exact|||||||>0.999
71095240|NCT03837938|141698755|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||=|0.861|||||||Fisher Exact|||||||=0.861
71095241|NCT03837938|141698756|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||<|0.001|||||||t-test, 1 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||Daytime at Visit 2, Day 4||||<0.001
70974290|NCT00662792|141455450|SUPERIORITY||Difference of adjusted means|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.71|TWO_SIDED|95.0|-0.03|0.02|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.02|-0.03|0.7100
71095242|NCT03837938|141698756|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||<|0.001|||||||t-test, 2 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||Daytime at Visit 3, Day 8||||<0.001
70921472|NCT04714320|141333624|SUPERIORITY||||||=|0.106||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 36||||=0.106
70921473|NCT04714320|141333624|SUPERIORITY||||||=|0.779||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 36||||=0.779
70974291|NCT00662792|141455450|SUPERIORITY||Difference of adjusted means|0.01|STANDARD_ERROR_OF_MEAN|0.01||0.3659|TWO_SIDED|95.0|-0.02|0.04|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.04|-0.02|0.3659
70921474|NCT04714320|141333624|SUPERIORITY||||||=|0.323||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 43||||=0.323
70974292|NCT00662792|141455451|SUPERIORITY||Difference of adjusted means|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.4416|TWO_SIDED|95.0|-0.04|0.02|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.02|-0.04|0.4416
71095243|NCT03837938|141698756|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||<|0.001|||||||t-test, 1 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||Nightime at Visit 2, Day 4||||<0.001
71095244|NCT03837938|141698756|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||<|0.001|||||||t-test, 1 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||Nighttime at Visit 3, Day 8||||<0.001
71095245|NCT03837938|141698757|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||<|0.001|||||||t-test, 1 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||Visit 2, Day 4||||<0.001
71095246|NCT03837938|141698757|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||<|0.001|||||||t-test, 1 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||at Visit 3, Day 8||||<0.001
70921475|NCT04714320|141333624|SUPERIORITY||||||=|0.991||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 43||||=0.991
70974293|NCT00662792|141455451|SUPERIORITY||Difference of adjusted means|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.7058|TWO_SIDED|95.0|-0.03|0.02|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.02|-0.03|0.7058
71095247|NCT03837938|141698758|NON_INFERIORITY|non-inferiority margin is defined as 20%|||||=|0.336|||||||t-test, 1 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||||||=0.336
71095248|NCT00504309|141698767|SUPERIORITY_OR_OTHER|||||||0.002|||||||Mixed Models Analysis|Tukey p-values were used for post hoc comparisons.||Fasting triglycerides (mg/dL) were measured on two consecutive days and averaged for analysis at the end of each treatment period. The null hypothesis was that triglycerides did not differ between groups.||||0.002
71095249|NCT00504309|141698767|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Mixed Models Analysis|||Cholesterol values were compared as the average of two fasting values at the end of each treatment. Cholesterol values included LDL-C, HDL-C, total cholesterol, and calculated ratios.||||> 0.05
71095250|NCT03158311|141698783|NON_INFERIORITY|Non-inferiority margin: 0.25 points|Least Square mean (LS Mean)|-0.038|STANDARD_ERROR_OF_MEAN|0.051|<|0.001|ONE_SIDED|97.5|-0.139|||P-Value is one-sided|Mixed Model for Repeated Measures (MMRM)||||||-0.139|<0.001
71095251|NCT03158311|141698783|NON_INFERIORITY|Non-inferiority margin: 0.25 points|LS Mean|0.073|STANDARD_ERROR_OF_MEAN|0.051|<|0.001|ONE_SIDED|97.5|-0.027|||P-Value is one-sided|MMRM||||||-0.027|<0.001
71095252|NCT03158311|141698784|SUPERIORITY||LS Mean|0.003|STANDARD_ERROR_OF_MEAN|0.025||0.892|TWO_SIDED|95.0|-0.046|0.052||P-value is two-sided|MMRM|||Week 8||0.052|-0.046|0.892
71095253|NCT03158311|141698784|SUPERIORITY||LS Mean|0.067|STANDARD_ERROR_OF_MEAN|0.025||0.007|TWO_SIDED|95.0|0.018|0.115||P-value is two-sided|MMRM|||Week 8||0.115|0.018|0.007
71095254|NCT03158311|141698784|SUPERIORITY||LS Mean|-0.002|STANDARD_ERROR_OF_MEAN|0.025||0.945|TWO_SIDED|95.0|-0.05|0.047||P-value is two-sided|MMRM|||Week 16||0.047|-0.050|0.945
70974294|NCT00662792|141455451|SUPERIORITY||Difference of adjusted means|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.1494|TWO_SIDED|95.0|-0.01|0.05|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.05|-0.01|0.1494
70974295|NCT00662792|141455452|SUPERIORITY||Difference of adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.998|TWO_SIDED|95.0|-0.06|0.06|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.06|-0.06|0.9980
71095255|NCT03158311|141698784|SUPERIORITY||LS Mean|0.066|STANDARD_ERROR_OF_MEAN|0.025||0.007|TWO_SIDED|95.0|0.018|0.114||P-value is two-sided|MMRM|||Week 16||0.114|0.018|0.007
71095256|NCT03158311|141698784|SUPERIORITY||LS Mean|0.009|STANDARD_ERROR_OF_MEAN|0.026||0.713|TWO_SIDED|95.0|-0.041|0.06||P-value is two-sided|MMRM|||Week 24||0.060|-0.041|0.713
71095257|NCT03158311|141698784|SUPERIORITY||LS Mean|0.096|STANDARD_ERROR_OF_MEAN|0.026|<|0.001|TWO_SIDED|95.0|0.046|0.146||P-value is two-sided|MMRM|||Week 24||0.146|0.046|<0.001
71095258|NCT03158311|141698785|SUPERIORITY||LS Mean|-0.023|STANDARD_ERROR_OF_MEAN|0.046||0.308|TWO_SIDED|95.0|-0.113|0.067||P-value is one-sided|MMRM|||Week 16||0.067|-0.113|0.308
71095259|NCT03158311|141698785|SUPERIORITY||LS Mean|-0.079|STANDARD_ERROR_OF_MEAN|0.046||0.044|TWO_SIDED|95.0|-0.169|0.012||P-value is one-sided|MMRM|||Week 16||0.012|-0.169|0.044
70921476|NCT04714320|141333624|SUPERIORITY||||||=|0.973||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 50||||=0.973
70921477|NCT04714320|141333624|SUPERIORITY||||||=|0.23||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 50||||=0.230
70974296|NCT00662792|141455452|SUPERIORITY||Difference of adjusted means|0.02|STANDARD_ERROR_OF_MEAN|0.03||0.4618|TWO_SIDED|95.0|-0.04|0.08|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.08|-0.04|0.4618
70974297|NCT00662792|141455452|SUPERIORITY||Difference of adjusted means|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.0418|TWO_SIDED|95.0|0.0|0.12|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.12|0.00|0.0418
70974298|NCT00662792|141455453|SUPERIORITY||Difference of adjusted means|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.4206|TWO_SIDED|95.0|-0.08|0.03|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.03|-0.08|0.4206
70974299|NCT00662792|141455453|SUPERIORITY||Difference of adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.8723|TWO_SIDED|95.0|-0.05|0.06|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.06|-0.05|0.8723
70974300|NCT00662792|141455453|SUPERIORITY||Difference of adjusted means|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.1005|TWO_SIDED|95.0|-0.01|0.11|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.11|-0.01|0.1005
70974301|NCT02347176|141455463|SUPERIORITY||Adjusted Mean Difference|-2.89|STANDARD_ERROR_OF_MEAN|1.968||0.143|TWO_SIDED|95.0|-6.78|0.99|||Mixed Model Repeated Measures Analysis|||||0.99|-6.78|0.143
70974302|NCT02347176|141455463|SUPERIORITY||Adjusted Mean Difference|-4.36|STANDARD_ERROR_OF_MEAN|1.951||0.027|TWO_SIDED|95.0|-8.22|-0.51|||Mixed Model Repeated Measures Analysis|||||-0.51|-8.22|0.027
70974303|NCT02347176|141455463|SUPERIORITY||Adjusted Mean Difference|-4.94|STANDARD_ERROR_OF_MEAN|1.932||0.011|TWO_SIDED|95.0|-8.76|-1.13|||Mixed Model Repeated Measures Analysis|||||-1.13|-8.76|0.011
70974304|NCT02347176|141455464|SUPERIORITY||Odds Ratio (OR)|0.98||||0.974|TWO_SIDED|95.0|0.29|3.32|||Regression, Logistic|||||3.32|0.29|0.974
70974305|NCT02347176|141455464|SUPERIORITY||Odds Ratio (OR)|1.85||||0.281|TWO_SIDED|95.0|0.61|5.65|||Regression, Logistic|||||5.65|0.61|0.281
70974306|NCT02347176|141455464|SUPERIORITY||Odds Ratio (OR)|2.83||||0.061|TWO_SIDED|95.0|0.95|8.37|||Regression, Logistic|||||8.37|0.95|0.061
70974307|NCT03403205|141455480|OTHER||LS Mean Difference|1.64|STANDARD_ERROR_OF_MEAN|0.254|<|0.0001|TWO_SIDED|95.0|1.14|2.13||Test was performed at a significance level of 0.05.|ANCOVA|||Analysis was performed using ANCOVA model, which included treatment, cohort, and baseline value. Missing imputation was performed: 1) for intermediate missing, interpolation was used to fill out missing values. 2) For participants who die, baseline dNCC was carried forward from discontinuation to week 48. 3) For others, multiple imputation was used to impute missing dNCC assuming data were missing not at random.||2.13|1.14|< 0.0001
70974308|NCT03403205|141455480|OTHER||LS Mean Difference|3.79|STANDARD_ERROR_OF_MEAN|0.584|<|0.0001|TWO_SIDED|95.0|2.65|4.94||Test was performed at a significance level of 0.05.|ANCOVA|||Analysis was performed using ANCOVA model, which included treatment, cohort, and baseline value. Missing imputation was performed: 1) for intermediate missing, interpolation was used to fill out missing values. 2) For participants who die, baseline dNCC was carried forward from discontinuation to week 48. 3) For others, multiple imputation was used to impute missing dNCC assuming data were missing not at random.||4.94|2.65|< 0.0001
70974309|NCT01834729|141455492|SUPERIORITY|||||||0.78|||||||Least squares means|||||||0.78
70974310|NCT01834729|141455493|SUPERIORITY|||||||0.57|||||||Least squares means|||||||0.57
70974311|NCT00288080|141455497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0398|||||||Log Rank|||The study was designed to detect an improvement in the 4-year overall survival rate from 86% (AS+RT) to 93% (AS+RT+CT). Assuming an exponential survival distribution for each arm, then an absolute improvement of 7% in the 4-year overall survival rate translates to a 51% relative reduction (hazard ratio 0.49) in the yearly death rate. Under a 1-sided significance level of 0.05 and 90% power, at least 78 deaths and 486 cases were required to perform the primary endpoint analysis.||||0.0398
70974312|NCT00288080|141455498|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22|||||||Log Rank|||Biochemical control rates at 4 years were calculated using the Kaplan-Meier method and compared by a two-sided log-rank test with a significance level of 0.05.||||0.22
71154220|NCT05785832|141801084|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.1|0.0|||Regression, Linear|||Adjusted Difference Between Groups||0.0|-0.1|
71095260|NCT03158311|141698785|SUPERIORITY||LS Mean|-0.032|STANDARD_ERROR_OF_MEAN|0.047||0.245|TWO_SIDED|95.0|-0.125|0.06||P-value is one sided|MMRM|||Week 24||0.060|-0.125|0.245
71154221|NCT05785832|141801085|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-0.5|1.2|||Regression, Linear|||Adjusted Difference Between Groups||1.2|-0.5|
71033264|NCT00840073|141576565|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|102.37||||||90.0|97.34|107.65|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107.65|97.34|
71033265|NCT00840073|141576566|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|103.76||||||90.0|100.08|107.57|||||Informational Purposes Only|||107.57|100.08|
71033266|NCT00840073|141576567|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Least Squares Means|103.34||||||90.0|100.84|105.92|||||Informational Purposes Only|||105.92|100.84|
71033267|NCT03285594|141576568|SUPERIORITY||Difference in Least Square (LS) Means|-0.45|STANDARD_ERROR_OF_MEAN|0.094|<|0.0001|TWO_SIDED|95.0|-0.638|-0.271|||ANCOVA|||The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline HbA1c as a covariate.||-0.271|-0.638|<0.0001
71033268|NCT03285594|141576568|SUPERIORITY||Difference in LS Means|-0.55|STANDARD_ERROR_OF_MEAN|0.081|<|0.0001|TWO_SIDED|95.0|-0.706|-0.387|||ANCOVA|||The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline HbA1c as a covariate.||-0.387|-0.706|<0.0001
71033269|NCT03285594|141576569|SUPERIORITY||Difference in LS Means|-15.858|STANDARD_ERROR_OF_MEAN|4.6056||0.0006|TWO_SIDED|95.0|-24.8845|-6.8309|||ANCOVA|||The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline FPG as a covariate.||-6.8309|-24.8845|0.0006
71033270|NCT03285594|141576569|SUPERIORITY||Difference in LS Means|-21.832|STANDARD_ERROR_OF_MEAN|4.0514|<|0.0001|TWO_SIDED|95.0|-29.7725|-13.8911|||ANCOVA|||The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline FPG as a covariate.||-13.8911|-29.7725|<0.0001
71033271|NCT03285594|141576570|SUPERIORITY||Difference in LS Means|-1.09|STANDARD_ERROR_OF_MEAN|0.32||0.0007|TWO_SIDED|95.0|-1.716|-0.462|||ANCOVA|||The change from baseline to Week 18 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline body weight as a covariate.||-0.462|-1.716|0.0007
71033272|NCT03285594|141576570|SUPERIORITY||Difference in LS Means|-1.73|STANDARD_ERROR_OF_MEAN|0.278|<|0.0001|TWO_SIDED|95.0|-2.274|-1.183|||ANCOVA|||The change from baseline to Week 18 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline body weight as a covariate.||-1.183|-2.274|<0.0001
71033273|NCT03285594|141576571|SUPERIORITY||Difference in LS Means|-3.91|STANDARD_ERROR_OF_MEAN|1.904||0.04|TWO_SIDED|95.0|-7.642|-0.178|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline SBP as a covariate.||-0.178|-7.642|0.04
71033274|NCT03285594|141576571|SUPERIORITY||Difference in LS Means|-3.83|STANDARD_ERROR_OF_MEAN|1.697||0.0239|TWO_SIDED|95.0|-7.161|-0.507|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline SBP as a covariate.||-0.507|-7.161|0.0239
71033275|NCT03285594|141576572|SUPERIORITY||Difference in LS Means|-4.94|STANDARD_ERROR_OF_MEAN|1.425|||TWO_SIDED|95.0|-7.73|-2.142||||||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline SBP as a covariate.||-2.142|-7.73|
71033276|NCT03285594|141576572|SUPERIORITY||Difference in LS Means|-3.89|STANDARD_ERROR_OF_MEAN|1.246||0.0018|TWO_SIDED|95.0|-6.333|-1.448|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline SBP as a covariate.||-1.448|-6.333|0.0018
71095261|NCT03158311|141698785|SUPERIORITY||LS Mean|-0.124|STANDARD_ERROR_OF_MEAN|0.047||0.004|TWO_SIDED|95.0|-0.216|-0.032||P-value is one sided|MMRM|||Week 24||-0.032|-0.216|0.004
71095262|NCT03158311|141698786|SUPERIORITY||LS Mean|0.018|STANDARD_ERROR_OF_MEAN|0.049||0.719|TWO_SIDED|95.0|-0.079|0.115||P-value is two-sided|MMRM|||||0.115|-0.079|0.719
71095263|NCT03158311|141698786|SUPERIORITY||LS Mean|0.082|STANDARD_ERROR_OF_MEAN|0.049||0.097|TWO_SIDED|95.0|-0.015|0.179||P-value is two-sided|MMRM|||||0.179|-0.015|0.097
71095264|NCT03158311|141698787|SUPERIORITY||Odds Ratio (OR)|1.23||||0.061|TWO_SIDED|95.0|0.94|1.61||P-value is one sided|Regression, Logistic|Logistic Regression Model via Generalized estimating equations (GEE)||||1.61|0.94|0.061
71095265|NCT03158311|141698787|SUPERIORITY||Odds Ratio (OR)|1.11||||0.227|TWO_SIDED|95.0|0.85|1.46||P-value is one-sided|Regression, Logistic|Logistic Regression Model via GEE||||1.46|0.85|0.227
71154222|NCT05785832|141801086|SUPERIORITY||Difference in percent of participants.|12.0|||||TWO_SIDED|95.0|1.0|21.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||21|1|
71095266|NCT03158311|141698788|SUPERIORITY||Odds Ratio (OR)|1.17||||0.108|TWO_SIDED|95.0|0.91|1.49||P-value is one sided|Regression, Logistic|Logistic regression model via the GEE||||1.49|0.91|0.108
71033277|NCT03285594|141576573|SUPERIORITY||Difference in LS Means|-0.52|STANDARD_ERROR_OF_MEAN|0.34||0.1265|TWO_SIDED|95.0|-1.185|0.147|||ANCOVA|||The change from baseline to Week 52 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline HbA1c as a covariate.||0.147|-1.185|0.1265
71033278|NCT03285594|141576573|SUPERIORITY||Difference in LS Means|-0.57|STANDARD_ERROR_OF_MEAN|0.32||0.074|TWO_SIDED|95.0|-1.199|0.055|||ANCOVA|||The change from baseline to Week 52 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline HbA1c as a covariate.||0.055|-1.199|0.074
71033279|NCT03285594|141576574|SUPERIORITY||Difference in LS Means|-1.01|STANDARD_ERROR_OF_MEAN|0.868||0.2466|TWO_SIDED|95.0|-2.707|0.696|||ANCOVA|||The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline body weight as a covariate.||0.696|-2.707|0.2466
71033280|NCT03285594|141576574|SUPERIORITY||Difference in LS Means|-0.65|STANDARD_ERROR_OF_MEAN|0.672||0.332|TWO_SIDED|95.0|-1.969|0.665|||ANCOVA|||The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline body weight as a covariate.||0.665|-1.969|0.332
71033281|NCT04608188|141576606|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71033282|NCT04608188|141576607|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71033283|NCT04608188|141576608|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71033284|NCT04608188|141576609|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71033285|NCT01141374|141576612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.0667|STANDARD_DEVIATION|17.28||0.352|TWO_SIDED|95.0|-76.0|23.0||The test of hypothesis was conducted with repeated measures ANOVA with Post hoc. It was performed parametric test to compare data and the statistical significance was p\<0.05.|ANOVA|||Null hypothesis: there was no statistical difference among 3 groups (control, needles and seeds) after 4 auriculotherapy sessions.||23.00|-76.00|0.352
71033286|NCT01141374|141576613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.9067|STANDARD_DEVIATION|19.21||0.023|TWO_SIDED|95.0|-67.0|37.0||It was verified the normality of data distribution and the homogeneity of variance.|ANOVA|As for the comparison between the scores, we used ANOVA for repeated measures.It was made post hoc to find the differences among groups.||It was carried out the analysis of variance (ANOVA) among the groups in the 3rd assessment (after 60 days and 8 sessions). The main objective was to compare the difference among the control group, seeds and needles and to recognize significant outcomes of auriculotherapy by seeds or needles.||37.00|-67.00|0.023
71033287|NCT03273153|141576614|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.2954|TWO_SIDED|95.0|0.88|1.5|||Regression, Cox|||||1.50|0.88|0.2954
71033288|NCT03134222|141576643|SUPERIORITY|||||||0.75|||||||Mixed-effect repeated measures model|||||||0.7500
71033289|NCT03134222|141576643|SUPERIORITY|||||||0.3047|||||||Mixed-effect repeated measures model|||||||0.3047
71033290|NCT03134222|141576644|SUPERIORITY|||||||0.8869|||||||Cochran-Mantel-Haenszel|||||||0.8869
71033291|NCT03134222|141576644|SUPERIORITY|||||||0.3293|||||||Cochran-Mantel-Haenszel|||||||0.3293
71033292|NCT03134222|141576645|SUPERIORITY|||||||0.7456|||||||Cochran-Mantel-Haenszel|||||||0.7456
71033293|NCT03134222|141576645|SUPERIORITY|||||||0.6407|||||||Cochran-Mantel-Haenszel|||||||0.6407
71033294|NCT03134222|141576646|OTHER||||||<|0.0001|||||||One sample exact binomial test|||||||<0.0001
71033295|NCT03134222|141576646|OTHER||||||<|0.0001|||||||One sample exact binomial test|||||||<0.0001
71033296|NCT03134222|141576647|OTHER||||||<|0.0001|||||||One sample exact binomial test|||||||<0.0001
71095267|NCT03158311|141698788|SUPERIORITY||Odds Ratio (OR)|1.33||||0.013|TWO_SIDED|95.0|1.03|1.7||P-Value is one sided|Regression, Logistic|Logistic regression model via the GEE||||1.70|1.03|0.013
71095268|NCT03158311|141698789|SUPERIORITY||LS Mean|-0.003|STANDARD_ERROR_OF_MEAN|0.027||0.908|TWO_SIDED|95.0|-0.055|0.049||P-Value is two-sided|MMRM|||Week 8||0.049|-0.055|0.908
71095269|NCT03158311|141698789|SUPERIORITY||LS Mean|0.053|STANDARD_ERROR_OF_MEAN|0.026||0.046|TWO_SIDED|95.0|0.001|0.104||P-Value is two-sided|MMRM|||Week 8||0.104|0.001|0.046
71033297|NCT03134222|141576647|OTHER||||||<|0.0001|||||||One sample exact binomial test|||||||<0.0001
71033298|NCT03290781|141576696|SUPERIORITY||Difference in Proportion|0.451|||<|0.001|TWO_SIDED|95.0|0.296|0.572||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.572|0.296|<0.001
71033299|NCT03290781|141576696|SUPERIORITY||Difference in Proportion|0.278|||<|0.001|TWO_SIDED|95.0|0.142|0.401||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.401|0.142|<0.001
71033300|NCT03290781|141576697|SUPERIORITY||Difference in Proportion|0.463|||<|0.001|TWO_SIDED|95.0|0.31|0.585||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.585|0.310|<0.001
71095270|NCT03158311|141698789|SUPERIORITY||LS Mean|0.004|STANDARD_ERROR_OF_MEAN|0.026||0.87|TWO_SIDED|95.0|-0.047|0.056||P-Value is two-sided|MMRM|||Week 16||0.056|-0.047|0.870
71095271|NCT03158311|141698789|SUPERIORITY||LS Mean|0.058|STANDARD_ERROR_OF_MEAN|0.026||0.028|TWO_SIDED|95.0|0.006|0.109||P-Value is two-sided|MMRM|||Week 16||0.109|0.006|0.028
70974313|NCT00288080|141455500|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21|||||||Log Rank|||Distant failure rates at 4 years were calculated using the Kaplan-Meier method and compared by a two-side log-rank test at the 0.05 significance level.||||0.21
70974314|NCT00288080|141455501|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0484|||||||Log Rank|||Disease-free survival rates were compared by a two-sided log-rank test at a significance level of 0.05.||||0.0484
70974315|NCT01235962|141455505|SUPERIORITY||Adjusted Hazard Ratio|0.862||||0.1649|TWO_SIDED|95.0|0.699|1.063|||Stratified Log-Rank|||||1.063|0.699|0.1649
70974316|NCT01235962|141455506|SUPERIORITY||Adjusted Hazard Ratio|0.998||||0.988|TWO_SIDED|95.0|0.759|1.311|||Stratified Log-Rank|||||1.311|0.759|0.9880
70974317|NCT01235962|141455508|SUPERIORITY||Adjusted Hazard Ratio|0.802||||0.0126|TWO_SIDED|95.0|0.675|0.954|||Stratified Log-Rank|||||0.954|0.675|0.0126
70974318|NCT01235962|141455509|SUPERIORITY||Adjusted Hazard Ratio|1.001||||0.9959|TWO_SIDED|95.0|0.796|1.257|||Stratified Log-Rank|||||1.257|0.796|0.9959
71033301|NCT03290781|141576697|SUPERIORITY||Difference in Proportion|0.339|||<|0.001|TWO_SIDED|95.0|0.197|0.463||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.463|0.197|<0.001
71033302|NCT03290781|141576698|SUPERIORITY||Difference in Proportion|0.497|||<|0.001|TWO_SIDED|95.0|0.337|0.62||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.620|0.337|<0.001
70974319|NCT01235962|141455511|SUPERIORITY||Adjusted Hazard Ratio|0.693||||0.0201|TWO_SIDED|95.0|0.51|0.943|||Stratified Log-Rank|||||0.943|0.510|0.0201
71033303|NCT03290781|141576698|SUPERIORITY||Difference in Proportion|0.294|||<|0.001|TWO_SIDED|95.0|0.148|0.425||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.425|0.148|<0.001
71095272|NCT03158311|141698789|SUPERIORITY||LS Mean|0.028|STANDARD_ERROR_OF_MEAN|0.028||0.303|TWO_SIDED|95.0|-0.026|0.083||P-Value is two-sided|MMRM|||Week 24||0.083|-0.026|0.303
70974320|NCT01235962|141455512|SUPERIORITY||Adjusted Hazard Ratio|1.004||||0.9865|TWO_SIDED|95.0|0.662|1.521|||Stratified Log-Rank|||||1.521|0.662|0.9865
70974321|NCT01235962|141455513|SUPERIORITY||Mean Difference (Week 52)|-3.397|||<|0.001|TWO_SIDED|95.0|-4.486|-2.307|||analysis of covariance|adjusted for baseline score using mixed-model||||-2.307|-4.486|<.001
70974322|NCT01235962|141455513|SUPERIORITY||Mean Difference (24M DFS FU)|-0.043||||0.93|TWO_SIDED|95.0|-1.003|0.917|||analysis of covariance|adjusted for baseline score using mixed-model||||0.917|-1.003|0.930
70974323|NCT01235962|141455513|SUPERIORITY||Mean Difference (36M DFS FU)|0.119||||0.828|TWO_SIDED|95.0|-0.958|1.196|||analysis of covariance|adjusted for baseline score using mixed-model||||1.196|-0.958|0.828
70974324|NCT01235962|141455513|SUPERIORITY||Mean Difference (48M DFS FU)|-0.347||||0.603|TWO_SIDED|95.0|-1.658|0.964|||analysis of covariance|adjusted for baseline score using mixed-model||||0.964|-1.658|0.603
70974325|NCT01235962|141455513|SUPERIORITY||Mean Difference (54M DFS FU)|-0.17||||0.841|TWO_SIDED|95.0|-1.843|1.503|||analysis of covariance|adjusted for baseline score using mixed-model||||1.503|-1.843|0.841
70974326|NCT01235962|141455514|SUPERIORITY||Mean Difference (Week 52)|-1.619|||<|0.001|TWO_SIDED|95.0|-2.283|-0.955|||analysis of covariance|adjusted for baseline score using mixed-model||||-0.955|-2.283|<.001
70974327|NCT01235962|141455514|SUPERIORITY||Mean Difference (24 M DFS FU)|-0.114||||0.726|TWO_SIDED|95.0|-0.75|0.522|||analysis of covariance|adjusted for baseline score using mixed-model||||0.522|-0.750|0.726
70974328|NCT01235962|141455514|SUPERIORITY||Mean Difference (36 M DFS FU)|-0.09||||0.801|TWO_SIDED|95.0|-0.789|0.609|||analysis of covariance|adjusted for baseline score using mixed-model||||0.609|-0.789|0.801
70974329|NCT01235962|141455514|SUPERIORITY||Meat Difference (48 M DFS FU)|-0.212||||0.617|TWO_SIDED|95.0|-1.044|0.32|||analysis of covariance|adjusted for baseline score using mixed-model||||0.320|-1.044|0.617
70974330|NCT01235962|141455514|SUPERIORITY||Mean Difference (54 M DFS FU)|0.341||||0.565|TWO_SIDED|95.0|-0.828|1.51|||adjusted for baseline score using mixedm|||||1.510|-0.828|0.565
71033304|NCT03290781|141576699|SUPERIORITY||Difference in Proportion|0.277|||<|0.001|TWO_SIDED|95.0|0.129|0.398||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.398|0.129|<0.001
71033305|NCT03290781|141576699|SUPERIORITY||Difference in Proportion|0.191|||<|0.001|TWO_SIDED|95.0|0.067|0.305||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.305|0.067|<0.001
71033306|NCT03290781|141576700|SUPERIORITY||Difference in Proportion|0.488|||<|0.001|TWO_SIDED|95.0|0.329|0.613||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.613|0.329|<0.001
71033307|NCT03290781|141576700|SUPERIORITY||Difference in Proportion|0.343|||<|0.001|TWO_SIDED|95.0|0.194|0.471||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.471|0.194|<0.001
71095273|NCT03158311|141698789|SUPERIORITY||LS Mean|0.095|STANDARD_ERROR_OF_MEAN|0.027|<|0.001|TWO_SIDED|95.0|0.041|0.148||P-Value is two-sided|MMRM|||Week 24||0.148|0.041|<0.001
71095274|NCT03158311|141698790|SUPERIORITY||LS Mean|0.02|STANDARD_ERROR_OF_MEAN|0.034||0.563|TWO_SIDED|95.0|-0.048|0.087||P-value is two-sided|MMRM|||Week 8||0.087|-0.048|0.563
71095275|NCT03158311|141698790|SUPERIORITY||LS Mean|0.062|STANDARD_ERROR_OF_MEAN|0.034||0.068|TWO_SIDED|95.0|-0.005|0.129||P-Value is two-sided|MMRM|||Week 8||0.129|-0.005|0.068
71095276|NCT03158311|141698790|SUPERIORITY||LS Mean|-0.007|STANDARD_ERROR_OF_MEAN|0.035||0.844|TWO_SIDED|95.0|-0.076|0.062||P-Value is two-sided|MMRM|||Week 16||0.062|-0.076|0.844
71033308|NCT03290781|141576701|SUPERIORITY||Difference in Proportion|0.431|||<|0.001|TWO_SIDED|95.0|0.28|0.554||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.554|0.280|<0.001
71095277|NCT03158311|141698790|SUPERIORITY||LS Mean|0.058|STANDARD_ERROR_OF_MEAN|0.035||0.097|TWO_SIDED|95.0|-0.01|0.125||P-Value is two-sided|MMRM|||Week 16||0.125|-0.010|0.097
71033309|NCT03290781|141576701|SUPERIORITY||Difference in Proportion|0.227|||<|0.001|TWO_SIDED|95.0|0.094|0.349||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.349|0.094|<0.001
71033310|NCT03290781|141576702|SUPERIORITY||Difference in Proportion|0.176|||<|0.001|TWO_SIDED|95.0|0.049|0.287||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.287|0.049|<0.001
71033311|NCT03290781|141576702|SUPERIORITY||Difference in Proportion|0.111|||<|0.005|TWO_SIDED|95.0|0.006|0.208||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.208|0.006|<0.005
71033312|NCT03290781|141576703|SUPERIORITY||||||<|0.001||||||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||||<0.001
71033313|NCT03290781|141576703|SUPERIORITY||||||=|0.005||||||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647- 303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||||=0.005
71033314|NCT01581658|141576742|SUPERIORITY_OR_OTHER||Geometric mean ratio|128.82|||||TWO_SIDED|90.0|105.962|156.604|||ANOVA|The model includes fixed effect for the renal function group||||156.604|105.962|
71095278|NCT03158311|141698790|SUPERIORITY||LS Mean|0.003|STANDARD_ERROR_OF_MEAN|0.036||0.927|TWO_SIDED|95.0|-0.067|0.074||P-Value is two-sided|MMRM|||Week 24||0.074|-0.067|0.927
71095279|NCT03158311|141698790|SUPERIORITY||LS Mean|0.089|STANDARD_ERROR_OF_MEAN|0.036||0.013|TWO_SIDED|95.0|0.019|0.159||P-Value is two-sided|MMRM|||Week 24||0.159|0.019|0.013
71095280|NCT01928771|141698809|SUPERIORITY_OR_OTHER||Rate ratio|0.55|||<|0.001|TWO_SIDED|95.0|0.42|0.71|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||0.71|0.42|<0.001
71154223|NCT05785832|141801087|SUPERIORITY||Difference in percent of participants.|18.0|||||TWO_SIDED|95.0|2.0|32.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||32|2|
71033315|NCT01581658|141576742|SUPERIORITY_OR_OTHER||Geometric mean ratio|143.82|||||TWO_SIDED|90.0|118.306|174.848|||ANOVA|The model includes fixed effect for the renal function group||||174.848|118.306|
71033316|NCT01581658|141576742|SUPERIORITY_OR_OTHER||Geometric mean ratio|152.31|||||TWO_SIDED|90.0|125.287|185.166|||ANOVA|The model includes fixed effect for the renal function group||||185.166|125.287|
71033317|NCT01581658|141576743|SUPERIORITY_OR_OTHER||Geometric mean ratio|93.5|||||TWO_SIDED|90.0|72.236|121.015|||ANOVA|The model includes fixed effect for the renal function group||||121.015|72.236|
71033318|NCT01581658|141576743|SUPERIORITY_OR_OTHER||Geometric mean ratio|92.18|||||TWO_SIDED|90.0|71.216|119.305|||ANOVA|The model includes fixed effect for the renal function group||||119.305|71.216|
71033319|NCT01581658|141576743|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.01|||||TWO_SIDED|90.0|72.63|121.674|||ANOVA|The model includes fixed effect for the renal function group||||121.674|72.630|
71033320|NCT02538523|141576744|SUPERIORITY||||||<|0.005|||||||Fisher Exact|||A Fischer's Exact Test for two independent proportions was conducted to compare the statistical significance of the 44.8% difference in proportion of successes between procedure groups at two-months post-procedure (study endpoint) relative to baseline evaluation.||||<0.005
71033321|NCT02538523|141576745|SUPERIORITY||||||<|0.05|||||||ANCOVA|||Differences is the statistical significance of change scores in ODI total score from study baseline to endpoint (two-months post-procedure) were evaluated by Analysis of Covariance (ANCOVA), with change from baseline to endpoint in ODI total score as the dependent variable, baseline ODI total score as the covariate and procedure group (Erchonia FX-635 or placebo laser) as a main effect.||||<0.05
71033322|NCT01597245|141576750|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71033323|NCT01597245|141576750|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71033324|NCT01597245|141576750|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71033325|NCT01597245|141576751|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71033326|NCT01597245|141576751|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71033327|NCT01597245|141576751|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71033328|NCT01597245|141576752|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.005
71033329|NCT01597245|141576752|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71033330|NCT01597245|141576752|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71033331|NCT01597245|141576753|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71033332|NCT01597245|141576753|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71033333|NCT01597245|141576753|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71033334|NCT01597245|141576754|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.008
71033335|NCT01597245|141576754|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71095281|NCT01928771|141698809|SUPERIORITY_OR_OTHER||Rate ratio|0.49|||<|0.001|TWO_SIDED|95.0|0.37|0.64|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||0.64|0.37|<0.001
70974331|NCT01235962|141455515|SUPERIORITY||Mean Difference (Week 52)|-0.077||||0.238|TWO_SIDED|95.0|-0.205|0.051|||analysis of covariance|adjusted for baseline score using mixed-model||||0.051|-0.205|0.238
70974332|NCT01235962|141455515|SUPERIORITY||Mean Difference (24M DFS FU)|-0.052||||0.442|TWO_SIDED|95.0|-0.185|0.081|||analysis of covariance|adjusted for baseline score using mixed-model||||0.081|-0.185|0.442
70974333|NCT01235962|141455515|SUPERIORITY||Mean Difference (36M DFS FU)|0.016||||0.819|TWO_SIDED|95.0|-0.125|0.158|||analysis of covariance|adjusted for baseline score using mixed-model||||0.158|-0.125|0.819
70974334|NCT01235962|141455515|SUPERIORITY||Mean Difference (48M DFS FU)|-0.119||||0.223|TWO_SIDED|95.0|-0.311|0.073|||analysis of covariance|analysis of covariance adjusted for baseline score using mixed-model||||0.073|-0.311|0.223
70974335|NCT01235962|141455515|SUPERIORITY||Mean Difference (54M DFS FU)|-0.203||||0.085|TWO_SIDED|95.0|-0.435|0.028|||analysis of covariance|adjusted for baseline score using mixed-model||||0.028|-0.435|0.085
70974336|NCT01235962|141455516|SUPERIORITY||Mean Difference (Week 52)|-1.394|||<|0.001|TWO_SIDED|95.0|-1.66|-1.129|||analysis of covariance|adjusted for baseline score using mixed-model||||-1.129|-1.660|<.001
70974337|NCT01235962|141455516|SUPERIORITY||Mean difference (24M DFS FU)|0.117||||0.083|TWO_SIDED|95.0|-0.015|0.249|||analysis of covariance|adjusted for baseline score using mixed-model||||0.249|-0.015|0.083
70974338|NCT01235962|141455516|SUPERIORITY||Mean Difference (36M DFS FU)|0.081||||0.307|TWO_SIDED|95.0|-0.074|0.236|||analysis of covariance|adjusted for baseline score using mixed-model||||0.236|-0.074|0.307
70974339|NCT01235962|141455516|SUPERIORITY||Mean Difference (48M DFS FU)|-0.029||||0.796|TWO_SIDED|95.0|-0.249|0.191|||analysis of covariance|adjusted for baseline score using mixed-model||||0.191|-0.249|0.796
70974340|NCT01235962|141455516|SUPERIORITY||Mean Difference (54M DFS FU)|-0.016||||0.885|TWO_SIDED|95.0|-0.237|0.205|||analysis of covariance|adjusted for baseline score using mixed-models||||0.205|-0.237|0.885
70974341|NCT01235962|141455517|SUPERIORITY||Mean Differencec (Week 52)|-0.27||||0.143|TWO_SIDED|95.0|-0.633|0.092|||analysis of covariance|adjusted for baseline score using mixed-model||||0.092|-0.633|0.143
70974342|NCT01235962|141455517|SUPERIORITY||Mean Difference (24M DFS FU)|0.069||||0.736|TWO_SIDED|95.0|-0.336|0.475|||analysis of covariance|adjusted for baseline score using mixed-model||||0.475|-0.336|0.736
70974343|NCT01235962|141455517|SUPERIORITY||Mean Difference (36M DFS FU)|0.188||||0.397|TWO_SIDED|95.0|-0.247|0.623|||analysis of covariance|adjusted for baseline score using mixed-model||||0.623|-0.247|0.397
70974344|NCT01235962|141455517|SUPERIORITY||Mean Difference (48M DFS FU)|0.081||||0.781|TWO_SIDED|95.0|-0.488|0.649|||analysis of covariance|adjusted for baseline score using mixed-model||||0.649|-0.488|0.781
70974345|NCT01235962|141455517|SUPERIORITY||Mean Difference (54M DFS FU)|-0.278||||0.503|TWO_SIDED|95.0|-1.094|0.539|||analysis of covariance|adjusted for baseline score using mixed-model||||0.539|-1.094|0.503
70974346|NCT01235962|141455518|SUPERIORITY||Mean Difference (Week 52 thermo)|-0.717||||0.49|TWO_SIDED|95.0|-2.751|1.318|||analysis of covariance|adjusted for baseline score using mixed-model||||1.318|-2.751|0.490
70974347|NCT01235962|141455518|SUPERIORITY||Mean Difference (24M DFS FU- thermo)|-0.285||||0.788|TWO_SIDED|95.0|-2.358|1.788|||analysis of covariance|adjusted for baseline score using mixed-model||||1.788|-2.358|0.788
70974348|NCT01235962|141455518|SUPERIORITY||Mean Difference (36M DFS FU- thermo)|1.18||||0.266|TWO_SIDED|95.0|-0.901|3.262|||analysis of covariance|adjusted for baseline score using mixed-model||||3.262|-0.901|0.266
70974349|NCT01235962|141455518|SUPERIORITY||Mean Difference (48M DFS FU - thermo)|0.725||||0.57|TWO_SIDED|95.0|-1.779|3.229|||analysis of covariance|adjusted for baseline score using mixed-model||||3.229|-1.779|0.570
70974350|NCT01235962|141455518|SUPERIORITY||Mean Difference (54M DFS FU - thermo)|2.023||||0.346|TWO_SIDED|95.0|-2.205|6.251|||analysis of covariance|adjusted for baseline score using mixed-model||||6.251|-2.205|0.346
70974351|NCT01235962|141455518|SUPERIORITY||Mean Difference (Week 52 - UI)|-0.018||||0.111|TWO_SIDED|95.0|-0.04|0.004|||analysis of covariance|adjusted for baseline score using mixed-model||||0.004|-0.040|0.111
70974352|NCT01235962|141455518|SUPERIORITY||Mean Difference (24M DFS FU - UI)|-0.02||||0.094|TWO_SIDED|95.0|-0.044|0.003|||analysis of covariance|adjusted for baseline score using mixed-model||||0.003|-0.044|0.094
71095282|NCT01928771|141698810|SUPERIORITY_OR_OTHER||Rate ratio|0.7||||0.047|TWO_SIDED|95.0|0.5|1.0|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||1.0|0.5|0.047
71095283|NCT01928771|141698810|SUPERIORITY_OR_OTHER||Rate ratio|0.83||||0.268|TWO_SIDED|95.0|0.59|1.16|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||1.16|0.59|0.268
70974353|NCT01235962|141455518|SUPERIORITY||Mean Difference (36M DFS FU - UI)|0.01||||0.49|TWO_SIDED|95.0|-0.018|0.037|||analysis of covariance|adjusted for baseline score using mixed-model||||0.037|-0.018|0.490
70974354|NCT01235962|141455518|SUPERIORITY||Mean Difference (48M DFS FU - UI)|-0.009||||0.58|TWO_SIDED|95.0|-0.043|0.024|||analysis of covariance|adjusted for baseline score using mixed-model||||0.024|-0.043|0.580
70974355|NCT01235962|141455518|SUPERIORITY||Mean Difference (54M DFS FU - UI)|0.017||||0.473|TWO_SIDED|95.0|-0.029|0.063|||analysis of covariance|adjusted for baseline score using mixed-model||||0.063|-0.029|0.473
70974356|NCT01235962|141455519|SUPERIORITY||Mean Difference (Week 52)|-3.536|||<|0.001|TWO_SIDED|95.0|-4.466|-2.606|||analysis of covariance|adjusted for baseline score using mixed-model||||-2.606|-4.466|<.001
70974357|NCT01235962|141455519|SUPERIORITY||Mean difference (24M DFS FU)|-0.102||||0.812|TWO_SIDED|95.0|-0.942|0.738|||analysis of covariance|adjusted for baseline score using mixed-model||||0.738|-0.942|0.812
70974358|NCT01235962|141455519|SUPERIORITY||Mean Difference (36M DFS FU)|0.233||||0.621|TWO_SIDED|95.0|-0.69|1.155|||analysis of covariance|adjusted for baseline score using mixed-model||||1.155|-0.690|0.621
70974359|NCT01235962|141455519|SUPERIORITY||Mean Difference (48M DFS FU)|0.082||||0.878|TWO_SIDED|95.0|-0.959|1.122|||analysis of covariance|adjusted for baseline score using mixed-model||||1.122|-0.959|0.878
70974360|NCT01235962|141455519|SUPERIORITY||Mean Difference (54M DFS FU)|0.412||||0.533|TWO_SIDED|95.0|-0.887|1.712|||analysis of covariance|adjusted for baseline score using mixed-model||||1.712|-0.887|0.533
70974361|NCT01235962|141455520|SUPERIORITY||Mean Difference (Week 52)|-1.515|||<|0.001|TWO_SIDED|95.0|-2.078|-0.952|||analysis of covariance|adjusted for baseline score using mixed-model||||-0.952|-2.078|<.001
70974362|NCT01235962|141455520|SUPERIORITY||Mean Difference (24M DFS FU)|0.014||||0.961|TWO_SIDED|95.0|-0.534|0.561|||analysis of covariance|adjusted for baseline score using mixed-model||||0.561|-0.534|0.961
70974363|NCT01235962|141455520|SUPERIORITY||Mean Difference (36M DFS FU)|0.043||||0.888|TWO_SIDED|95.0|-0.555|0.641|||analysis of covariance|adjusted for baseline score using mixed-model||||0.641|-0.555|0.888
70974364|NCT01235962|141455520|SUPERIORITY||Mean Difference (48M DFS FU)|-0.061||||0.858|TWO_SIDED|95.0|-0.736|0.614|||analysis of covariance|adjusted for baseline score using mixed-model||||0.614|-0.736|0.858
70974365|NCT01235962|141455520|SUPERIORITY||Mean Difference (54M DFS FU)|0.452||||0.3|TWO_SIDED|95.0|-0.404|1.309|||analysis of covariance|adjusted for baseline score using mixed-model||||1.309|-0.404|0.300
70974366|NCT01235962|141455521|SUPERIORITY||Mean Difference (Week 52)|-0.103||||0.059|TWO_SIDED|95.0|-0.211|0.004|||analysis of covariance|adjusted for baseline score using mixed-model||||0.004|-0.211|0.059
70974367|NCT01235962|141455521|SUPERIORITY||Mean Difference (24M DFS FU)|-0.041||||0.487|TWO_SIDED|95.0|-0.155|0.074|||analysis of covariance|adjusted for baseline score using mixed-model||||0.074|-0.155|0.487
70974368|NCT01235962|141455521|SUPERIORITY||Mean Difference (36M DFS FU)|0.037||||0.885|TWO_SIDED|95.0|-0.085|0.16|||analysis of covariance|adjusted for baseline score using mixed-model||||0.160|-0.085|0.885
70974369|NCT01235962|141455521|SUPERIORITY||Mean Difference (48M DFS FU)|-0.032||||0.676|TWO_SIDED|95.0|-0.183|0.119|||analysis of covariance|adjusted for baseline score using mixed-model||||0.119|-0.183|0.676
70974370|NCT01235962|141455521|SUPERIORITY||Mean Difference (54M DFS FU)|-0.015||||0.859|TWO_SIDED|95.0|-0.183|0.153|||analysis of covariance|adjusted for baseline score using mixed-model||||0.153|-0.183|0.859
70974371|NCT01235962|141455522|SUPERIORITY||Mean Diffeence (Week 52)|-1.535|||<|0.001|TWO_SIDED|95.0|-1.769|-1.3|||analysis of covariance|adjusted for baseline score using mixed-model||||-1.300|-1.769|<.001
70974372|NCT01235962|141455522|SUPERIORITY||Mean Diffeence (24M DFS FU)|0.089||||0.127|TWO_SIDED|95.0|-0.025|0.202|||analysis of covariance|adjusted for baseline score using mixed-model||||0.202|-0.025|0.127
71033336|NCT01597245|141576754|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71033337|NCT01597245|141576755|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
71033338|NCT01597245|141576755|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
71033339|NCT01597245|141576756|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71033340|NCT01597245|141576756|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71033341|NCT01597245|141576756|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71033342|NCT01597245|141576757|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
70974373|NCT01235962|141455522|SUPERIORITY||Mean Diffeence (36M DFS FU)|0.123||||0.069|TWO_SIDED|95.0|-0.009|0.255|||analysis of covariance|adjusted for baseline score using mixed-model||||0.255|-0.009|0.069
70974374|NCT01235962|141455522|SUPERIORITY||Mean Diffeence (48M DFS FU)|0.049||||0.544|TWO_SIDED|95.0|-0.11|0.208|||analysis of covariance|adjusted for baseline score using mixed-model||||0.208|-0.110|0.544
70974375|NCT01235962|141455522|SUPERIORITY||Mean Difference (54M DFS FU)|0.061||||0.518|TWO_SIDED|95.0|-0.124|0.246|||analysis of covariance|adjusted for baseline score using mixed-model||||0.246|-0.124|0.518
70974376|NCT01235962|141455523|SUPERIORITY||Mean Diffeence (Week 52)|-0.374||||0.022|TWO_SIDED|95.0|-0.695|-0.053|||analysis of covariance|adjusted for baseline score using mixed-model||||-0.053|-0.695|0.022
70974377|NCT01235962|141455523|SUPERIORITY||Mean Diffeence (24M DFS FU)|-0.104||||0.567|TWO_SIDED|95.0|-0.462|0.253|||analysis of covariance|adjusted for baseline score using mixed-model||||0.253|-0.462|0.567
71033343|NCT01597245|141576757|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71033344|NCT01597245|141576757|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71033345|NCT01597245|141576758|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||Mixed Models Analysis|||||||0.002
71033346|NCT01597245|141576758|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71033347|NCT01597245|141576758|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71033348|NCT01597245|141576759|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71033349|NCT01597245|141576759|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71033350|NCT01597245|141576759|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71033351|NCT01597245|141576760|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71033352|NCT01597245|141576760|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71033353|NCT01597245|141576760|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71033354|NCT01597245|141576761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|TWO_SIDED||||||ANCOVA|||||||0.150
71033355|NCT01597245|141576761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||ANCOVA|||||||0.002
71033356|NCT01597245|141576761|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
71033357|NCT01597245|141576762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026|TWO_SIDED||||||ANCOVA|||Absenteeism Score||||0.026
71033358|NCT01597245|141576762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.076|TWO_SIDED||||||ANCOVA|||Absenteeism Score||||0.076
71033359|NCT01597245|141576762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.016|TWO_SIDED||||||ANCOVA|||Absenteeism Score||||0.016
71033360|NCT01597245|141576762|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Activity Impairment Score||||<0.001
71033361|NCT01597245|141576762|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Activity Impairment Score||||<0.001
71033362|NCT01597245|141576762|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Activity Impairment Score||||<0.001
71033363|NCT01597245|141576762|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Presenteeism Score||||<0.001
71033364|NCT01597245|141576762|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Presenteeism Score||||<0.001
71033365|NCT01597245|141576762|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Presenteeism Score||||<0.001
71095284|NCT01928771|141698811|SUPERIORITY_OR_OTHER||Rate ratio|0.61||||0.053|TWO_SIDED|95.0|0.37|1.01|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations resulting in ER/hospitalization in the previous year, and use of OCS||||1.01|0.37|0.053
71095285|NCT01928771|141698811|SUPERIORITY_OR_OTHER||Rate ratio|0.37|||<|0.001|TWO_SIDED|95.0|0.2|0.67|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations resulting in ER/hospitalization in the previous year, and use of OCS||||0.67|0.2|<0.001
71095286|NCT01928771|141698812|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.54|||<|0.001|TWO_SIDED|95.0|0.37|0.78|||Cochran-Mantel-Haenszel|Controlling for region, number of exacerbations in the previous year, use of OCS||Proportion of patients with \>=1 asthma exacerbation||0.78|0.37|<0.001
71095287|NCT01928771|141698812|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62||||0.01|TWO_SIDED|95.0|0.43|0.9|||Cochran-Mantel-Haenszel|Controlling for region, number of exacerbations from the previous year, use of OCS||Proportion of patients with \>=1 asthma exacerbation||0.90|0.43|0.01
71095288|NCT01928771|141698813|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.001|TWO_SIDED|95.0|0.49|0.82|||Regression, Cox|Model includes treatment, number of exacerbations in the previous year, region, use of OCS||Time to first exacerbation||0.82|0.49|<0.001
71095289|NCT01928771|141698813|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6|||<|0.001|TWO_SIDED|95.0|0.46|0.78|||Regression, Cox|Model includes treatment, number of exacerbations from the previous year, region, use of OCS||Time to first exacerbation||0.78|0.46|<0.001
71095290|NCT01928771|141698814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106||||0.022|TWO_SIDED|95.0|0.016|0.196|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit and treatment by visit||||0.196|0.016|0.022
71095291|NCT01928771|141698814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159||||0.001|TWO_SIDED|95.0|0.068|0.249|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit and treatment by visit||||0.249|0.068|0.001
71095292|NCT01928771|141698815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025||||0.644|TWO_SIDED|95.0|-0.134|0.083|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit and treatment by visit||||0.083|-0.134|0.644
71095293|NCT01928771|141698815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102||||0.057|TWO_SIDED|95.0|-0.003|0.208|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit and treatment by visit||||0.208|-0.003|0.057
71095294|NCT01928771|141698816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.442|TWO_SIDED|95.0|-0.27|0.12|||Mixed Models Analysis|Model includes treatment, baseline asthma symptom score, region, use of OCS, visit and visit by treatment||||0.12|-0.27|0.442
71154224|NCT05785832|141801088|SUPERIORITY||Difference in percent of participants.|23.0|||||TWO_SIDED|95.0|12.0|33.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||33|12|
71154225|NCT05785832|141801089|SUPERIORITY||Difference in percent of participants.|25.0|||||TWO_SIDED|95.0|11.0|38.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||38|11|
71095295|NCT01928771|141698816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.012|TWO_SIDED|95.0|-0.45|-0.06|||Mixed Models Analysis|Model includes treatment, baseline asthma symptom score, region, use of OCS, visit and visit by treatment||||-0.06|-0.45|0.012
71095296|NCT01928771|141698817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.169|TWO_SIDED|95.0|-0.48|0.08|||Mixed Models Analysis|Model includes treatment, baseline asthma symptom score, region, use of OCS, visit and visit by treatment||||0.08|-0.48|0.169
71095297|NCT01928771|141698817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.043|TWO_SIDED|95.0|-0.57|-0.01|||Mixed Models Analysis|Model includes treatment, baseline asthma symptom score, region, use of OCS, visit and visit by treatment||||-0.01|-0.57|0.043
71095298|NCT01928771|141698818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.1|TWO_SIDED|95.0|-1.16|0.1|||Mixed Models Analysis|Model includes treatment, baseline asthma medication use, region, use of OCS, visit and visit by treatment||||0.10|-1.16|0.1
71095299|NCT01928771|141698818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.081|TWO_SIDED|95.0|-1.21|0.07|||Mixed Models Analysis|Model includes treatment, baseline asthma medication use, region, use of OCS, visit and visit by treatment||||0.07|-1.21|0.081
71095300|NCT01928771|141698819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.32||||0.001|TWO_SIDED|95.0|9.2|37.43|||Mixed Models Analysis|Model includes treatment, baseline morning PEF, region, use of OCS, visit and visit by treatment||Morning PEF change from baseline to Week 48||37.43|9.20|0.001
71095301|NCT01928771|141698819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.46||||0.025|TWO_SIDED|95.0|2.08|30.83|||Mixed Models Analysis|Model includes treatment, baseline morning PEF, region, use of OCS, visit and visit by treatment||Morning PEF change from baseline to Week 48||30.83|2.08|0.025
71095302|NCT01928771|141698820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.75||||0.002|TWO_SIDED|95.0|7.86|35.65|||Mixed Models Analysis|Model includes treatment, baseline evening PEF, region, use of OCS, visit and visit by treatment||Evening PEF change from baseline to Week 48||35.65|7.86|0.002
71095303|NCT01928771|141698820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.18||||0.008|TWO_SIDED|95.0|5.09|33.28|||Mixed Models Analysis|Model includes treatment, baseline evening PEF, region, use of OCS, visit and visit by treatment||Evening PEF change from baseline to Week 48||33.28|5.09|0.008
71095304|NCT01928771|141698821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.964|TWO_SIDED|95.0|-0.05|0.04|||Mixed Models Analysis|Model includes treatment, baseline proportion of nights with nocturnal awakenings, region, use of OCS, visit and visit by treatment||||0.04|-0.05|0.964
71154226|NCT05785832|141801090|SUPERIORITY||Difference in percent of participants.|22.0|||||TWO_SIDED|95.0|11.0|33.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||33|11|
71154227|NCT05785832|141801091|SUPERIORITY||Difference in percent of participants.|21.0|||||TWO_SIDED|95.0|10.0|32.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||32|10|
71154228|NCT05785832|141801092|SUPERIORITY||Difference in percent of participants.|21.0|||||TWO_SIDED|95.0|9.0|31.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||31|9|
71033366|NCT01597245|141576762|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Score||||<0.001
71033367|NCT01597245|141576762|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Score||||<0.001
71033368|NCT01597245|141576762|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Score||||<0.001
71033369|NCT01597245|141576763|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Physical Summary Score||||<0.001
71033370|NCT01597245|141576763|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Physical Summary Score||||<0.001
71033371|NCT01597245|141576763|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Physical Summary Score||||<0.001
71033372|NCT01597245|141576763|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Mental Summary Score||||<0.001
71033373|NCT01597245|141576763|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Mental Summary Score||||<0.001
71033374|NCT01597245|141576763|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Mental Summary Score||||<0.001
71033375|NCT01597245|141576764|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71033376|NCT01597245|141576764|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71033377|NCT01597245|141576764|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71154229|NCT05785832|141801093|SUPERIORITY||Median Difference (Net)|10.0|||||TWO_SIDED|95.0|7.0|12.0||||||Adjusted Difference Between Groups||12|7|
71033378|NCT01597245|141576765|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 50||||<0.001
71033379|NCT01597245|141576765|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 50||||<0.001
71033380|NCT01597245|141576765|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 50||||<0.001
71033381|NCT01597245|141576765|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 75||||<0.001
71033382|NCT01597245|141576765|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 75||||<0.001
71033383|NCT01597245|141576765|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 75||||<0.001
71033384|NCT01597245|141576765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 100||||0.002
71033385|NCT01597245|141576765|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 100||||<0.001
71033386|NCT01597245|141576765|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 100||||<0.001
71033387|NCT00583453|141576788|SUPERIORITY_OR_OTHER|||||||0.674||||||Treatment x day interaction|Wilcoxon (Mann-Whitney)|||||||.674
71033388|NCT00583453|141576789|SUPERIORITY_OR_OTHER|||||||0.018||||||Treatment x day interaction reported as 0.018.|Wilcoxon (Mann-Whitney)|||||||0.018
71033389|NCT00583453|141576790|SUPERIORITY_OR_OTHER|||||||0.214||||||Treatment x day interaction = 0.214|Wilcoxon (Mann-Whitney)|||||||.214
71033390|NCT00583453|141576792|SUPERIORITY_OR_OTHER|||||||0.036||||||treatment x day interaction P = 0.036 Treatment main effect (average day 1 to 10) P = 0.003|Wilcoxon (Mann-Whitney)|||||||0.036
71033391|NCT00567320|141576824|SUPERIORITY_OR_OTHER_LEGACY|||||||0.84|TWO_SIDED|95.0|||||Mixed Models Analysis|||HLM analysis of % of Cocaine Positive Urines per week over 12 weeks. Subjects were used as a Random variable, with medication dosing set to 'Fixed'.||||0.84
71033392|NCT02115347|141576846|SUPERIORITY_OR_OTHER||Ratio (Test/Reference) of Adjusted Means|87.31|||||TWO_SIDED|90.0|68.01|112.08|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals \[CIs\]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).|||112.08|68.01|
71033393|NCT02115347|141576847|SUPERIORITY_OR_OTHER||Ratio (Test/Reference) of Adjusted Means|87.43|||||TWO_SIDED|90.0|68.11|112.22|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals \[CIs\]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).|||112.22|68.11|
71033394|NCT02115347|141576848|SUPERIORITY_OR_OTHER||Ratio (Test/Reference) of Adjusted Means|95.81|||||TWO_SIDED|90.0|72.4|126.79|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals \[CIs\]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).|||126.79|72.40|
71033395|NCT02115347|141576849|SUPERIORITY_OR_OTHER||Ratio (Test/Reference) of Adjusted Means|95.92|||||TWO_SIDED|90.0|72.46|126.97|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals \[CIs\]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).|||126.97|72.46|
71033396|NCT02115347|141576850|SUPERIORITY_OR_OTHER||Ratio (Test/Reference) of Adjusted Means|78.7|||||TWO_SIDED|90.0|65.74|94.23|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals \[CIs\]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).|||94.23|65.74|
71033397|NCT02115347|141576851|SUPERIORITY_OR_OTHER||Ratio (Test/Reference) of Adjusted Means|86.52|||||TWO_SIDED|90.0|70.49|106.2|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals \[CIs\]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).|||106.20|70.49|
71033398|NCT00834340|141576855|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|92.2|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111|92.2|
71033399|NCT00834340|141576856|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.5||||||90.0|94.0|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|94.0|
71033400|NCT00834340|141576857|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|102.0||||||90.0|98.7|105.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105|98.7|
71154230|NCT05785832|141801094|SUPERIORITY||Mean Difference (Net)|-0.01|||||TWO_SIDED|95.0|-0.02|0.01||||||||0.01|-0.02|
71154231|NCT05785832|141801095|SUPERIORITY||Mean Difference (Net)|-0.03|||||TWO_SIDED|95.0|-0.07|0.01||||||Adjusted Difference Between Groups||0.01|-0.07|
71095305|NCT01928771|141698821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.012|TWO_SIDED|95.0|-0.11|-0.01|||Mixed Models Analysis|Model includes treatment, baseline proportion of nights with nocturnal awakenings, region, use of OCS, visit and visit by treatment||||-0.01|-0.11|0.012
70974378|NCT01235962|141455523|SUPERIORITY||Mean Difference (36M DFS FU)|0.072||||0.706|TWO_SIDED|95.0|-0.302|0.446|||analysis of covariance|adjusted for baseline score using mixed-model||||0.446|-0.302|0.706
71095306|NCT01928771|141698822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.111|TWO_SIDED|95.0|-0.34|0.04|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit and visit by treatment||||0.04|-0.34|0.111
71095307|NCT01928771|141698822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.003|TWO_SIDED|95.0|-0.48|-0.1|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit and visit by treatment||||-0.10|-0.48|0.003
71095308|NCT01928771|141698823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED|95.0|-0.27|0.27|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit and visit by treatment||||0.27|-0.27|0.99
71154232|NCT05785832|141801096|SUPERIORITY||Mean Difference (Net)|-4.4|||||TWO_SIDED|95.0|-6.0|-2.7||||||Adjusted Difference Between Groups||-2.7|-6.0|
70974379|NCT01235962|141455523|SUPERIORITY||Mean Difference (48M DFS FU)|0.12||||0.612|TWO_SIDED|95.0|-0.343|0.583|||analysis of covariance|adjusted for baseline score using mixed-model||||0.583|-0.343|0.612
70974380|NCT01235962|141455523|SUPERIORITY||Mean Difference (54M DFS FU)|-0.045||||0.87|TWO_SIDED|95.0|-0.587|0.496|||analysis of covariance|adjusted for baseline score using mixed-model||||0.496|-0.587|0.870
70974381|NCT01235962|141455524|SUPERIORITY||Mean Difference (Week 52 - thermo.)|-2.116||||0.018|TWO_SIDED|95.0|-3.872|-0.359|||analysis of covariance|adjusted for baseline score using mixed-model||||-0.359|-3.872|0.018
70974382|NCT01235962|141455524|SUPERIORITY||Mean Difference (24M DFS FU - thermo)|-0.253||||0.778|TWO_SIDED|95.0|-2.014|1.508|||analysis of covariance|adjusted for baseline score using mixed-model||||1.508|-2.014|0.778
70974383|NCT01235962|141455524|SUPERIORITY||Mean Difference (36M DFS FU - thermo)|0.847||||0.376|TWO_SIDED|95.0|-1.03|2.724|||analysis of covariance|adjusted for baseline score using mixed-model||||2.724|-1.030|0.376
71095309|NCT01928771|141698823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.107|TWO_SIDED|95.0|-0.48|0.05|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit and visit by treatment||||0.05|-0.48|0.107
71095310|NCT01928771|141698827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.081|TWO_SIDED|95.0|-0.02|0.37|||Mixed Models Analysis|Model includes covariates treatment, baseline AQLQ(S)+12 score, region, use of OCS, visit, and visit by treatment||||0.37|-0.02|0.081
71095311|NCT01928771|141698827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.004|TWO_SIDED|95.0|0.1|0.5|||Mixed Models Analysis|Model includes covariates treatment, baseline AQLQ(S)+12 score, region, use of OCS, visit, and visit by treatment||||0.5|0.1|0.004
71095312|NCT01407367|141698878|OTHER||Hazard Ratio (HR)|0.38||||0.04|TWO_SIDED|95.0|0.16|0.94||calculated p-value. Results adjusted for gender, race, age, BMI, MAP, eGFR, smoking history, diabetes, hypertension, cardiovascular disease, cancer, education employment status, health literacy and RAAS use.|Regression, Cox|||||0.94|0.16|.04
71095313|NCT01407367|141698879|OTHER||Hazard Ratio (HR)|1.03||||0.86|TWO_SIDED|95.0|0.53|1.99||calculated p-value. Results adjusted for gender, race, age, BMI, MAP, eGFR, smoking history, diabetes, hypertension, cardiovascular disease, cancer, education employment status, health literacy and RAAS use.|Regression, Cox|||||1.99|0.53|0.86
71154233|NCT05785832|141801097|SUPERIORITY||Mean Difference (Net)|-14.0|||||TWO_SIDED|95.0|-18.0|-10.0||||||Adjusted Difference Between Groups||-10|-18|
71154234|NCT05785832|141801098|SUPERIORITY||Mean Difference (Net)|-3.9|||||TWO_SIDED|95.0|-5.2|-2.7||||||Adjusted Difference Between Groups||-2.7|-5.2|
70974384|NCT01235962|141455524|SUPERIORITY||Mean Difference (48M DFS FU - thermo)|0.131||||0.905|TWO_SIDED|95.0|-2.032|2.294|||analysis of covariance|adjusted for baseline score using mixed-model||||2.294|-2.032|0.905
70974385|NCT01235962|141455524|SUPERIORITY||Mean Difference (54M DFS FU - thermo)|0.401||||0.768|TWO_SIDED|95.0|-2.269|3.071|||analysis of covariance|adjusted for baseline score using mixed-model||||3.071|-2.269|0.768
70974386|NCT01235962|141455524|SUPERIORITY||Mean Difference (Week 52 - UI)|-0.026||||0.007|TWO_SIDED|95.0|-0.044|-0.007|||analysis of covariance|adjusted for baseline score using mixed-model||||-0.007|-0.044|0.007
70974387|NCT01235962|141455524|SUPERIORITY||Mean Difference (24M DFS FU - UI)|-0.016||||0.13|TWO_SIDED|95.0|-0.036|0.005|||analysis of covariance|adjusted for baseline score using mixed-model||||0.005|-0.036|0.130
70974388|NCT01235962|141455524|SUPERIORITY||Mean Difference (36M DFS FU - UI)|0.007||||0.52|TWO_SIDED|95.0|-0.015|0.03|||analysis of covariance|adjusted for baseline score using mixed-model||||0.030|-0.015|0.520
70974389|NCT01235962|141455524|SUPERIORITY||Mean Difference (48M DFS FU - UI)|-0.014||||0.276|TWO_SIDED|95.0|-0.04|0.011|||analysis of covariance|adjusted for baseline score using mixed-model||||0.011|-0.040|0.276
70974390|NCT01235962|141455524|SUPERIORITY||Mean Difference (54M DFS FU - UI)|-0.007||||0.665|TWO_SIDED|95.0|-0.037|0.024|||analysis of covariance|adjusted for baseline score using mixed-model||||0.024|-0.037|0.665
70974391|NCT00087646|141455526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0||||0.006|TWO_SIDED|95.0|1.21|3.31|||Cochran-Mantel-Haenszel|||Group A Vs Group D||3.31|1.21|0.0060
70974392|NCT00087646|141455527|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9228|TWO_SIDED|95.0|0.63|1.51|||Cochran-Mantel-Haenszel|||||1.51|0.63|0.9228
70974393|NCT00087646|141455528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.22||||0.0006|TWO_SIDED|95.0|1.4|3.52|||Cochran-Mantel-Haenszel|||||3.52|1.40|0.0006
70974394|NCT00087646|141455529|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.64|||<|0.0001|TWO_SIDED|95.0|1.66|4.18|||Cochran-Mantel-Haenszel|||At Week 12||4.18|1.66|<.0001
70974395|NCT00087646|141455529|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.1955|TWO_SIDED|95.0|0.89|1.79|||Cochran-Mantel-Haenszel|||At Week 24||1.79|0.89|0.1955
70974396|NCT00087646|141455529|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.0883|TWO_SIDED|95.0|0.95|1.93|||Cochran-Mantel-Haenszel|||At Week 48||1.93|0.95|0.0883
70974397|NCT00087646|141455530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.31|||<|0.0001|TWO_SIDED|95.0|1.67|3.19|||Cochran-Mantel-Haenszel|||Groups A vs Groups D (Week 12)||3.19|1.67|<.0001
70974398|NCT00087646|141455530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.3389|TWO_SIDED|95.0|0.85|1.6|||Cochran-Mantel-Haenszel|||Groups A vs Groups D (Week 24)||1.60|0.85|0.3389
71154235|NCT05785832|141801099|SUPERIORITY||Difference in percent of participants.|16.0|||||TWO_SIDED|95.0|8.0|24.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||24|8|
70974399|NCT01331304|141455534|SUPERIORITY_OR_OTHER|||||||0.59||||||Because this study has co-primary outcomes (CGI-EI and NCAs), the analyses of the treatment effect in the two primary hypotheses each involved a two-tailed alpha-level of 0.025.|Mixed Models Analysis|||For the first co-primary aim, mixed-effects linear regression analyses compared the two intervention groups on the repeated assessments of the CGI-EI over 6 months.||||0.59
70974400|NCT01331304|141455535|SUPERIORITY_OR_OTHER|||||||0.118|||||||Wilcoxon (Mann-Whitney)|||For the second co-primary, patient monthly rates of NCAs (determined by dividing total number of NCAs during follow-up by the length of follow-up - to account for attrition and resulting differential exposure time) for treatment groups were compared using a Wilcoxon rank-sum test.||||0.118
70974401|NCT01331304|141455536|SUPERIORITY|||||||0.11||||||Analysis of this secondary outcome was not corrected for multiple comparisons. Therefore, the a priori threshold for statistical significance was set at 0.05|Mixed Models Analysis|||Mixed-effects linear regression analyses compared the two intervention groups on the repeated collection of measures relevant to calculation of the Framingham Risk Score over 6 months||||0.11
71033401|NCT02849457|141576861|SUPERIORITY||Mean Difference (Final Values)|-0.6565|STANDARD_ERROR_OF_MEAN|3.9332||0.8681|TWO_SIDED|95.0|-8.5567|7.2436|||Mixed Models Analysis|Adjusted for age (\<=7 vs \>7 months) at randomization and sex. Unstructured covariance used among 12 and 24 month outcomes.|Parameter represents estimated amount difference in group means. Negative value represents higher mean in placebo group.|||7.2436|-8.5567|0.8681
71033402|NCT02849457|141576862|SUPERIORITY|||||||0.7375|||||||Chi-squared|||||||0.7375
71033403|NCT02849457|141576863|SUPERIORITY||Hazard Ratio (HR)|0.593||||0.1174|TWO_SIDED|95.0|0.309|1.14|||Regression, Cox|Adjusted for age (\<=7 vs \>7 months) at randomization and sex.||||1.140|0.309|0.1174
71033404|NCT02849457|141576864|OTHER|Two-sided test of non-equivalence||||||0.4653|||||||Chi-squared|||||||0.4653
71033405|NCT02849457|141576865|SUPERIORITY||Mean Difference (Final Values)|-4.4392|STANDARD_ERROR_OF_MEAN|3.1889||0.1697|TWO_SIDED|95.0|-10.8346|1.9562|||Mixed Models Analysis|Adjusted for age at randomization (\<=7 vs \>7 months) and sex. Unstructured covariance used among 12, 24, and 36 month outcomes.|Pertains to the estimated difference in mean score between groups at study visit corresponding to 24 months of age.|||1.9562|-10.8346|0.1697
71033406|NCT03673670|141576879|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.021||||0.168|TWO_SIDED|95.0|0.991|1.052|||ANCOVA|||||1.052|0.991|0.168
71033407|NCT03673670|141576879|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|0.995||||0.731|TWO_SIDED|95.0|0.966|1.025|||ANCOVA|||||1.025|0.966|0.731
71033408|NCT03673670|141576880|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.024||||0.115|TWO_SIDED|95.0|0.994|1.055|||ANCOVA|||||1.055|0.994|0.115
71033409|NCT03673670|141576880|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.024||||0.111|TWO_SIDED|95.0|0.994|1.055|||ANCOVA|||||1.055|0.994|0.111
71033410|NCT03673670|141576881|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.014||||0.303|TWO_SIDED|95.0|0.987|1.043|||ANCOVA|||||1.043|0.987|0.303
71033411|NCT03673670|141576882|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.027||||0.067|TWO_SIDED|95.0|0.998|1.057|||ANCOVA|||||1.057|0.998|0.067
71154236|NCT05785832|141801100|SUPERIORITY||Difference in percent of participants.|26.0|||||TWO_SIDED|95.0|12.0|41.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||41|12|
71154237|NCT05785832|141801101|SUPERIORITY||Difference in percent of participants.|34.0|||||TWO_SIDED|95.0|21.0|45.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||45|21|
71154238|NCT05785832|141801104|SUPERIORITY||Difference in percent of participants.|15.0|||||TWO_SIDED|95.0|8.0|22.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||22|8|
70974402|NCT01331304|141455537|SUPERIORITY|||||||0.7||||||Analysis of this secondary outcome was not corrected for multiple comparisons. Therefore, the a priori threshold for statistical significance was set at 0.05|Mixed Models Analysis|||Mixed-effects linear regression analyses compared the two intervention groups on the repeated assessment of the LIFE-RIFT over 6 months||||0.70
71154239|NCT05785832|141801105|SUPERIORITY||Mean Difference (Net)|-10.0|||||TWO_SIDED|95.0|-20.0|0.0||||||Adjusted Difference Between Groups.||0|-20|
70921478|NCT04714320|141333624|SUPERIORITY||||||=|0.792||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 57||||=0.792
70921479|NCT04714320|141333624|SUPERIORITY||||||=|0.744||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 57||||=0.744
70921480|NCT04714320|141333624|SUPERIORITY|Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|||||=|0.925|||||||Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 64||||=0.925
70921481|NCT04714320|141333624|SUPERIORITY||||||=|0.991||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 64||||=0.991
70921482|NCT04714320|141333624|SUPERIORITY|Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|||||=|0.53|||||||Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 71||||=0.530
70921483|NCT04714320|141333624|SUPERIORITY||||||=|0.849||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 71||||=0.849
70921484|NCT04714320|141333624|SUPERIORITY||||||=|0.953||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 78||||=0.953
70921485|NCT04714320|141333624|SUPERIORITY||||||=|0.884||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 78||||=0.884
70974403|NCT04925752|141455575|SUPERIORITY||Rate Ratio|0.043|||<|0.0001|TWO_SIDED|95.0|0.01|0.182||p-value for rate ratio vs bHIV is from Wald test.|Wald test||Confidence Interval (CI) for rate ratio vs bHIV is based on the delta method.|Null Hypothesis 01: LEN/bHIV\>= 1; Null hypothesis was to be rejected if HIV-1 incidence in LEN was significantly lower than bHIV.||0.182|0.010|<0.0001
70921486|NCT04714320|141333624|SUPERIORITY||||||=|0.23||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 85||||=0.230
70921487|NCT04714320|141333624|SUPERIORITY||||||=|0.589||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 85||||=0.589
71154240|NCT05785832|141801106|SUPERIORITY||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-4.4|3.4||||||Adjusted Difference Between Groups.||3.4|-4.4|
70921488|NCT04714320|141333624|SUPERIORITY||||||=|0.919||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 92||||=0.919
70921489|NCT04714320|141333624|SUPERIORITY||||||=|0.753||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 92||||=0.753
70974404|NCT04925752|141455575|SUPERIORITY||Rate Ratio|0.043|||<|0.0001|TWO_SIDED|95.0|0.01|0.182||p-value for rate ratio vs bHIV is from Wald test.|Wald test||CI for rate ratio vs bHIV is based on the delta method.|Null Hypothesis 02: LEN/bHIV\>= 0.8; Null hypothesis was to be rejected if HIV-1 incidence in LEN was significantly and at least 20% lower than bHIV.||0.182|0.010|< 0.0001
70974405|NCT04925752|141455576|OTHER|Null Hypothesis 03: LEN - F/TDF\>= 0.8/100PY; Null hypothesis was to be rejected if HIV-1 incidence in LEN is not substantially greater than F/TDF (LEN is comparable to F/TDF).|Rate difference|-0.828|||<|0.0001|TWO_SIDED|95.0|-1.669|-0.255||p-value for rate difference (SC LEN minus F/TDF) is based on a hybrid approach.|Hybrid approach||Exact CI for rate difference versus F/TDF is based on a hybrid approach.|||-0.255|-1.669|<0.0001
70974406|NCT04925752|141455576|SUPERIORITY||Rate Ratio|0.111||||0.00245|TWO_SIDED|95.0|0.024|0.513||P-value for rate ratio versus F/TDF is from a Poisson model.|Poisson model||Confidence interval for rate ratio versus F/TDF is from a Poisson model.|Null Hypothesis 04: LEN vs F/TDF\>= 1; Null hypothesis was to be rejected if HIV-1 incidence in LEN was significantly lower than F/TDF.||0.513|0.024|0.00245
70974407|NCT04202679|141455586|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0216|TWO_SIDED|95.0|1.08|5.0||Threshold of significance at 0.05 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when primary outcome measure was statistically significant at two-sided 0.05.||5.00|1.08|0.0216
71154241|NCT05785832|141801107|SUPERIORITY||Median Difference (Net)|1.5|||||TWO_SIDED|95.0|0.5|2.5||||||Adjusted Difference Between Groups.||2.5|0.5|
71154242|NCT05785832|141801108|SUPERIORITY||Mean Difference (Net)|1.1|||||TWO_SIDED|95.0|-2.5|4.7||||||Adjusted Difference Between Groups.||4.7|-2.5|
71154243|NCT05785832|141801109|SUPERIORITY||Mean Difference (Net)|-1.3|||||TWO_SIDED|95.0|-3.4|0.7||||||Adjusted Difference Between Groups.||0.7|-3.4|
70921490|NCT04714320|141333624|SUPERIORITY||||||=|0.747||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 106||||=0.747
70921491|NCT04714320|141333624|SUPERIORITY||||||=|0.764||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 106||||=0.764
70921492|NCT04714320|141333624|SUPERIORITY||||||=|0.527||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 120||||=0.527
70921493|NCT04714320|141333624|SUPERIORITY||||||=|0.639||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 120||||=0.639
70921494|NCT04714320|141333624|SUPERIORITY||||||=|0.744||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 148||||=0.744
70921495|NCT04714320|141333624|SUPERIORITY||||||=|0.539||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 148||||=0.539
70921496|NCT04714320|141333624|SUPERIORITY||||||=|0.417||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 169||||=0.417
70921497|NCT04714320|141333624|SUPERIORITY||||||=|0.466||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 169||||=0.466
70921498|NCT04714320|141333624|SUPERIORITY||||||=|0.38||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 8||||=0.380
70921499|NCT04714320|141333624|SUPERIORITY||||||=|0.73||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 8||||=0.730
70921500|NCT04714320|141333624|SUPERIORITY||||||=|0.595||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 15||||=0.595
70974408|NCT04202679|141455587|SUPERIORITY||Odds Ratio (OR)|9.0|||<|0.0001|TWO_SIDED|95.0|3.56|22.66||Threshold of significance at 0.05 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||22.66|3.56|<0.0001
70974409|NCT04202679|141455588|SUPERIORITY||Odds Ratio (OR)|4.4|||<|0.0001|TWO_SIDED|95.0|2.02|9.55||Threshold of significance at 0.05 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||9.55|2.02|<0.0001
70974410|NCT04202679|141455589|SUPERIORITY||Odds Ratio (OR)|6.1||||0.0001|TWO_SIDED|95.0|2.03|18.11||Threshold of significance at 0.05 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05||18.11|2.03|0.0001
70921501|NCT04714320|141333624|SUPERIORITY||||||=|0.279||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 15||||=0.279
70921502|NCT04714320|141333624|SUPERIORITY||||||=|0.196||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 22||||=0.196
70921503|NCT04714320|141333624|SUPERIORITY||||||=|0.728||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 22||||=0.728
70921504|NCT04714320|141333624|SUPERIORITY||||||=|0.453||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 29||||=0.453
71154244|NCT05785832|141801110|SUPERIORITY||Median Difference (Net)|2.1|||||TWO_SIDED|95.0|0.5|3.7||||||Adjusted Difference Between Groups.||3.7|0.5|
71095314|NCT01271855|141698880|SUPERIORITY||Z-Score|0.93||||0.35|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The z-score is a standardized version of the Wilcoxon test statistic. In this study, z-scores with an absolute value exceeding 1.96 signal the two groups have meaningfully different pain scores. Other values would fail to reject the null hypothesis.|The null hypothesis is that there is no difference in the visual analogue pain score scale (VAS) between participants in the Glycerin suppository group and those in the Belladonna and opioid suppository group 24-hours after delivery.||||.35
71095315|NCT01271855|141698881|SUPERIORITY||Odds Ratio (OR)|1.88||||0.3|TWO_SIDED|95.0|0.57|6.21|||Regression, Logistic|||The null hypothesis is that there is no difference in the odds of taking additional pain medications between participants in the Glycerin suppository group and those in the Belladonna and opioid suppository group 24-hours after delivery.||6.21|0.57|.30
70921505|NCT04714320|141333624|SUPERIORITY||||||=|0.681||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 29||||=0.681
70921506|NCT04714320|141333624|SUPERIORITY||||||=|0.863||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 36||||=0.863
70921507|NCT04714320|141333624|SUPERIORITY||||||=|0.837||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 36||||=0.837
70921508|NCT04714320|141333624|SUPERIORITY||||||=|0.504||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 43||||=0.504
70921509|NCT04714320|141333624|SUPERIORITY||||||=|0.531||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 43||||=0.531
70921510|NCT04714320|141333624|SUPERIORITY||||||=|0.6||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 50||||=0.600
70921511|NCT04714320|141333624|SUPERIORITY||||||=|0.83||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 50||||=0.830
70921512|NCT04714320|141333624|SUPERIORITY||||||=|0.209||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 57||||=0.209
70921513|NCT04714320|141333624|SUPERIORITY||||||=|0.809||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 57||||=0.809
70921514|NCT04714320|141333624|SUPERIORITY||||||=|0.045||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 64||||=0.045
70921515|NCT04714320|141333624|SUPERIORITY||||||=|0.104||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 64||||=0.104
70921516|NCT04714320|141333624|SUPERIORITY||||||=|0.69||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 71||||=0.690
70921517|NCT04714320|141333624|SUPERIORITY||||||=|0.59||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 71||||=0.590
70921518|NCT04714320|141333624|SUPERIORITY||||||=|0.538||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 78||||=0.538
70921519|NCT04714320|141333624|SUPERIORITY||||||=|0.407||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 78||||=0.407
70921520|NCT04714320|141333624|SUPERIORITY||||||=|0.398||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 85||||=0.398
70974411|NCT04202679|141455590|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0194|TWO_SIDED|95.0|1.13|7.52||Threshold of significance at 0.05 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||7.52|1.13|0.0194
70974412|NCT04202679|141455591|SUPERIORITY||LS mean difference|-23.16|||<|0.0001|TWO_SIDED|95.0|-33.81|-12.51||Threshold of significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-12.51|-33.81|<0.0001
70974413|NCT04202679|141455592|SUPERIORITY||LS mean difference|-6.39|||<|0.0001|TWO_SIDED|95.0|-8.42|-4.36||Threshold of significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-4.36|-8.42|<0.0001
70974414|NCT04202679|141455593|SUPERIORITY||LS mean difference|-1.61||||0.0003|TWO_SIDED|95.0|-2.49|-0.73||Threshold of significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-0.73|-2.49|0.0003
70974415|NCT04202679|141455594|SUPERIORITY||LS mean difference|0.54||||0.1658|TWO_SIDED|95.0|-0.22|1.3||Threshold of significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||1.30|-0.22|0.1658
70974416|NCT04202679|141455602|SUPERIORITY||LS mean difference|-0.61||||0.037|TWO_SIDED|95.0|-1.18|-0.04||Threshold of significance was \<0.05.|ANCOVA||Dupilumab 300 mg q2w versus Placebo|||-0.04|-1.18|0.0370
70974417|NCT01680900|141455609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.06||||0.05|TWO_SIDED|95.0|-2.6|-0.48|||Regression, Linear|||||-0.48|-2.60|0.05
70974418|NCT01680900|141455610|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
70974419|NCT01680900|141455611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|||<|0.05|TWO_SIDED|95.0|-0.75|-0.08|||Regression, Linear|||||-0.08|-0.75|<0.05
70974420|NCT01680900|141455615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.05|TWO_SIDED|95.0|-0.74|-0.21|||Regression, Linear|||||-0.21|-0.74|0.05
70974421|NCT02066792|141455623|SUPERIORITY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.81|-0.21||two-sided|Mixed Models Analysis|Four level multivariate MLM with measures nested within time, which was nested within subjects, who were nested within treatment cohort.||At 3 month follow-up||-.21|-.81|<.001
70974422|NCT02066792|141455623|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.15||0.635|TWO_SIDED|95.0|-0.37|0.23||Two-sided|Mixed Models Analysis|Four level multivariate MLM with measures nested within time, which was nested within subjects, who were nested within treatment cohort.||3 month follow-up||.23|-.37|.635
70974423|NCT02066792|141455623|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.16||0.002|TWO_SIDED|95.0|-0.8|-0.18|||Mixed Models Analysis|Four level multivariate MLM with measures nested within time, which was nested within subjects, who were nested within treatment cohort.||||-.18|-.80|.002
70974424|NCT02066792|141455623|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.15||0.004|TWO_SIDED|95.0|-0.73|-0.14|||Mixed Models Analysis|Four level multivariate MLM with measures nested within time, which was nested within subjects, who were nested within treatment cohort.||3 month follow-up||-.14|-.73|.004
70974425|NCT02066792|141455623|SUPERIORITY||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.16||0.008|TWO_SIDED|95.0|-0.72|-0.11|||Mixed Models Analysis|Four level multivariate MLM with measures nested within time, which was nested within subjects, who were nested within treatment cohort.||3 month follow-up||-.11|-.72|.008
70974426|NCT02723201|141455624|SUPERIORITY_OR_OTHER||LS Mean Difference|0.402|||<|0.001|TWO_SIDED|90.0|0.32|0.505|||ANOVA|||Analysis of variance (ANOVA) was performed on the natural logarithms of Cmax with regimen as the fixed effects and participant as the random effect. The point estimate and 90 percent (%) confidence interval (CI) was obtained by taking the antilog of the difference in the log transformed least square (LS) means and its CI, respectively.||0.505|0.320|<0.001
71033412|NCT03673670|141576882|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.012||||0.395|TWO_SIDED|95.0|0.984|1.042|||ANCOVA|||||1.042|0.984|0.395
71033413|NCT03673670|141576883|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.012||||0.404|TWO_SIDED|95.0|0.984|1.039|||ANCOVA|||||1.039|0.984|0.404
71033414|NCT03673670|141576884|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.082||||0.001|TWO_SIDED|95.0|1.043|1.123|||ANCOVA|||||1.123|1.043|0.001
71154245|NCT05785832|141801111|SUPERIORITY||Mean Difference (Net)|4.9|||||TWO_SIDED|95.0|-1.4|11.1||||||Adjusted Difference Between Groups.||11.1|-1.4|
71154246|NCT05785832|141801112|SUPERIORITY||Mean Difference (Net)|-20.0|||||TWO_SIDED|95.0|-45.0|4.0||||||Adjusted Difference Between Groups.||4|-45|
71095316|NCT01271855|141698882|SUPERIORITY||Z-Score|2.34||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The z-score is a standardized version of the Wilcoxon test statistic. In this study, z-scores with an absolute value exceeding 1.96 signal the two groups have meaningfully different satisfaction scores. Other values fail to reject the null hypothesis|The null hypothesis is that there is no difference in the pain satisfaction score between participants in the Glycerin suppository group and those in the Belladonna and opioid suppository group at discharge||||.02
71095317|NCT01452347|141698883|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean ratio|74.22|STANDARD_ERROR_OF_MEAN|1.05||||95.0|68.08|80.91|||ANOVA|The Ctrough,ss (predicted or observed) was log transformed (natural logarithm) prior to fitting the ANOVA model.|"The standard error of the mean is actually the geometric standard error.~(Observed vs Predicted)"|"Null hypothesis: The difference of the population average responses was either ≤ to the lower bound or ≥ to the upper bound of the acceptance range .~Alternative hypothesis: The difference of the population average responses was both \> than the lower bound and \< than the upper bound of the acceptance range \[Note: The acceptance range for the geometric mean is 80-125%\]"||80.91|68.08|
71095318|NCT01452347|141698884|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean ratio|84.46|STANDARD_ERROR_OF_MEAN|1.11||||95.0|70.32|101.44|||ANOVA|The Ctrough,ss (predicted or observed) was log transformed (natural logarithm) prior to fitting the ANOVA model.|"The standard error of the mean is actually the geometric standard error.~(Observed vs Predicted)"|"Null hypothesis: The difference of the population average responses was either ≤ to the lower bound or ≥ to the upper bound of the acceptance range .~Alternative hypothesis: The difference of the population average responses was both \> than the lower bound and \< than the upper bound of the acceptance range \[Note: The acceptance range for the geometric mean is 80-125%\]"||101.44|70.32|
71095319|NCT01452347|141698885|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean ratio|95.5|STANDARD_ERROR_OF_MEAN|1.05||||95.0|88.69|102.84|||ANOVA|The Ctrough,ss (predicted or observed) was log transformed (natural logarithm) prior to fitting the ANOVA model.|"The standard error of the mean is actually the geometric standard error.~(Observed vs Predicted)"|"Null hypothesis: The difference of the population average responses was either ≤ to the lower bound or ≥ to the upper bound of the acceptance range .~Alternative hypothesis: The difference of the population average responses was both \> than the lower bound and \< than the upper bound of the acceptance range \[Note: The acceptance range for the geometric mean is 80-125%\]"||102.84|88.69|
71095320|NCT01452347|141698886|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean ratio|103.25|STANDARD_ERROR_OF_MEAN|1.11||||95.0|86.4|123.4|||ANOVA|The Ctrough,ss (predicted or observed) was log transformed (natural logarithm) prior to fitting the ANOVA model.|"The standard error of the mean is actually the geometric standard error.~(Observed vs Predicted)"|"Null hypothesis: The difference of the population average responses was either ≤ to the lower bound or ≥ to the upper bound of the acceptance range .~Alternative hypothesis: The difference of the population average responses was both \> than the lower bound and \< than the upper bound of the acceptance range \[Note: The acceptance range for the geometric mean is 80-125%\]"||123.40|86.40|
71154247|NCT03414684|141801124|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.88|TWO_SIDED|95.0|0.49|1.84|||Log Rank|stratified log rank test|Reference level is Arm B, such that hazard ratio corresponds to the effect of treatment on Arm A|||1.84|0.49|0.88
71154248|NCT03414684|141801125|SUPERIORITY||Odds Ratio (OR)|1.09||||1|TWO_SIDED|95.0|0.29|4.18|||Fisher Exact||Reference level is Arm B, such that the odds ratio corresponds to the effect of treatment on Arm A|||4.18|0.29|1
71033415|NCT03673670|141576884|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.061||||0.002|TWO_SIDED|95.0|1.023|1.101|||ANCOVA|||||1.101|1.023|0.002
71033416|NCT03673670|141576885|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.02||||0.096|TWO_SIDED|95.0|0.997|1.043|||ANCOVA|||||1.043|0.997|0.096
71033417|NCT03673670|141576885|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.002||||0.862|TWO_SIDED|95.0|0.979|1.025|||ANCOVA|||||1.025|0.979|0.862
71033418|NCT03673670|141576886|OTHER||Median Difference (Final Values)|0.0||||0.945|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.945
71033419|NCT03673670|141576886|OTHER||Median Difference (Final Values)|0.0||||0.501|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.501
71033420|NCT01175018|141576917|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
71033421|NCT01175018|141576918|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>0.05
71033422|NCT01175018|141576919|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
71033423|NCT01175018|141576920|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>0.05
71033424|NCT01175018|141576921|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Log Rank|||||||<0.05
71033425|NCT01175018|141576922|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
71033426|NCT01175018|141576923|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>0.05
71033427|NCT01175018|141576924|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>0.05
71033428|NCT01175018|141576925|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>0.05
71033429|NCT01175018|141576926|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
71033430|NCT01175018|141576927|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
71033431|NCT01175018|141576928|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
71033432|NCT01175018|141576929|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
71033433|NCT01175018|141576930|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
70921521|NCT04714320|141333624|SUPERIORITY||||||=|0.93||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 85||||=0.930
70921522|NCT04714320|141333624|SUPERIORITY||||||=|0.111||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 92||||=0.111
71033434|NCT01175018|141576931|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
71033435|NCT01175018|141576932|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
71033436|NCT00575159|141576944|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.728||||0.0008|TWO_SIDED|95.0|-4.219|-1.236|||ANCOVA|||Difference from placebo to GSK189075 50mg AUC(0-4) Incremental Adjusted Weighted Mean||-1.236|-4.219|0.0008
71033437|NCT00575159|141576944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.325||||0.0021|TWO_SIDED|95.0|-3.735|-0.916|||ANCOVA|||Difference from placebo toGSK189075 150mg AUC(0-4) Incremental Adjusted Weighted Mean||-0.916|-3.735|0.0021
71033438|NCT00575159|141576944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.402||||0.0021|TWO_SIDED|95.0|-3.862|-0.942|||ANCOVA|||Difference from placebo to GSK189075 500mg AUC(0-4) Incremental Adjusted Weighted Mean||-0.942|-3.862|0.0021
71033439|NCT00575159|141576944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.556||||0.0382|TWO_SIDED|95.0|0.09|3.021|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 50mg AUC(0-4) Incremental Adjusted Weighted Mean||3.021|0.090|0.0382
71033440|NCT00575159|141576944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.958||||0.0132|TWO_SIDED|95.0|0.439|3.477|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 150mg AUC(0-4) Incremental Adjusted Weighted Mean||3.477|0.439|0.0132
70921523|NCT04714320|141333624|SUPERIORITY||||||=|0.196||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 92||||=0.196
70921524|NCT04714320|141333624|SUPERIORITY||||||=|0.816||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 106||||=0.816
70921525|NCT04714320|141333624|SUPERIORITY||||||=|0.473||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 106||||=0.473
70921526|NCT04714320|141333624|SUPERIORITY||||||=|0.615||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 120||||=0.615
70921527|NCT04714320|141333624|SUPERIORITY||||||=|0.214||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 120||||=0.214
70921528|NCT04714320|141333624|SUPERIORITY||||||=|0.575||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 148||||=0.575
70921529|NCT04714320|141333624|SUPERIORITY||||||=|0.276||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 148||||=0.276
70921530|NCT04714320|141333624|SUPERIORITY||||||=|0.573||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 169||||=0.573
70921531|NCT04714320|141333624|SUPERIORITY||||||=|0.706||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 169||||=0.706
70921532|NCT04714320|141333625|SUPERIORITY||||||=|0.853||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables|ANCOVA|||Change from Baseline at Day 8||||=0.853
70921533|NCT04714320|141333625|SUPERIORITY||||||=|0.542||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 8||||=0.542
70921534|NCT04714320|141333625|SUPERIORITY||||||=|0.43||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 15||||=0.430
70921535|NCT04714320|141333625|SUPERIORITY||||||=|0.587||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 15||||=0.587
70921536|NCT04714320|141333625|SUPERIORITY||||||=|0.91||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 22||||=0.910
71154249|NCT03414684|141801127|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.49|TWO_SIDED|95.0|0.43|1.5|||Log Rank|stratified log rank test|Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A|||1.50|0.43|0.49
70974427|NCT02723201|141455624|SUPERIORITY_OR_OTHER||LS Mean Difference|1.216||||0.249|TWO_SIDED|90.0|1.016|1.455|||ANOVA|||ANOVA was performed on the natural logarithms of Cmax with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||1.455|1.016|0.249
70974428|NCT02723201|141455624|SUPERIORITY_OR_OTHER||LS Mean Difference|0.055|||<|0.001|TWO_SIDED|90.0|0.041|0.074|||ANOVA|||ANOVA was performed on the natural logarithms of Cmax with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||0.074|0.041|<0.001
70974429|NCT02723201|141455624|SUPERIORITY_OR_OTHER||LS Mean Difference|0.685||||0.054|TWO_SIDED|90.0|0.499|0.939|||ANOVA|||ANOVA was performed on the natural logarithms of Cmax with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||0.939|0.499|0.054
70974430|NCT02723201|141455626|SUPERIORITY_OR_OTHER||LS Mean Difference|0.648||||0.007|TWO_SIDED|90.0|0.497|0.844|||ANOVA|||ANOVA was performed on the natural logarithms of AUC∞ with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||0.844|0.497|0.007
70974431|NCT02723201|141455626|SUPERIORITY_OR_OTHER||LS Mean Difference|1.18||||0.423|TWO_SIDED|90.0|1.088|1.279|||ANOVA|||ANOVA was performed on the natural logarithms of AUC∞ with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||1.279|1.088|0.423
70974432|NCT02723201|141455626|SUPERIORITY_OR_OTHER||LS Mean Difference|0.116|||<|0.001|TWO_SIDED|90.0|0.077|0.176|||ANOVA|||ANOVA was performed on the natural logarithms of AUC∞ with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||0.176|0.077|<0.001
70974433|NCT02723201|141455626|SUPERIORITY_OR_OTHER||LS Mean Difference|0.836||||0.037|TWO_SIDED|90.0|0.731|0.957|||ANOVA|||ANOVA was performed on the natural logarithms of AUC∞ with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||0.957|0.731|0.037
70974434|NCT00584233|141455658|NON_INFERIORITY|The statistical test will be to assess non-inferiority. The non-inferiority margin is -0.04 in AUC. Key parameters are the number of participating patients, the number of radiologists reading the images in the study. Power analysis was conducted using the standard simulation from the ROC literature (Roe and Metz, Academic Radiology 1997). With a total of 100 participating patients and 4 participating readers, we achieve a power \>80% with a non-inferiority margin of -0.04.|Obuchowski Rockette methodology|0.05||||0.05|TWO_SIDED|95.0|0.025|0.975|||Obuchowski Rockette|||The analysis is intended to evaluate non-inferiority in observer performance between CE-bCT and CE-bMRI as assessed by the area under the ROC curve (AUC). The null hypothesis is that the observed difference in average AUC for CE-bCT and CE-bMRI will be outside of a non-inferiority margin of -0.04. See below for details of the power analyses.||.975|.025|0.05
70974435|NCT01340209|141455692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.048||0.7971|TWO_SIDED|95.0|-0.082|0.106|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 2.5 µg minus placebo||0.106|-0.082|0.7971
70974436|NCT01340209|141455692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.048||0.0203|TWO_SIDED|95.0|0.018|0.207|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 5 μg minus placebo||0.207|0.018|0.0203
71033441|NCT00575159|141576944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.881||||0.0161|TWO_SIDED|95.0|0.373|3.389|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 500mg AUC(0-4) Incremental Adjusted Weighted Mean||3.389|0.373|0.0161
71033442|NCT00575159|141576944|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.592||||0.0001|TWO_SIDED|95.0|-5.162|-2.022|||ANCOVA|||Difference from placebo to GSK189075 50mg AUC(0-10) Incremental Adjusted Weighted Mean||-2.022|-5.162|0.0001
71033443|NCT00575159|141576944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.82||||0|TWO_SIDED|95.0|-5.304|-2.337|||ANCOVA|||Difference from placebo to GSK189075 150mg AUC(0-10) Incremental Adjusted Weighted Mean||-2.337|-5.304|0.0000
71033444|NCT00575159|141576944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.887||||0.0006|TWO_SIDED|95.0|-4.424|-1.35|||ANCOVA|||Difference from placebo to GSK189075 500mg AUC(0-10) Incremental Adjusted Weighted Mean||-1.350|-4.424|0.0006
71033445|NCT00575159|141576944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.953||||0.0005|TWO_SIDED|95.0|1.411|4.496|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 50mg AUC(0-10) Incremental Adjusted Weighted Mean||4.496|1.411|0.0005
71033446|NCT00575159|141576944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.725||||0.0015|TWO_SIDED|95.0|1.126|4.324|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 150mg AUC(0-10) Incremental Adjusted Weighted Mean||4.324|1.126|0.0015
71033447|NCT00575159|141576944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.659||||0.0001|TWO_SIDED|95.0|2.071|5.246|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 500mg AUC(0-10) Incremental Adjusted Weighted Mean||5.246|2.071|0.0001
71033448|NCT03872128|141576975|SUPERIORITY|||||||0.009|||||||Fisher Exact|||||||0.009
71033449|NCT03872128|141576976|SUPERIORITY|||||||0.019|||||||Fisher Exact|||||||0.019
71033450|NCT03872128|141576977|SUPERIORITY|||||||0.044|||||||Fisher Exact|||||||0.044
71033451|NCT03872128|141576978|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||OCDS: Total||||<0.001
71033452|NCT03872128|141576978|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||OCDS: Obsessive||||<0.001
71033453|NCT03872128|141576978|SUPERIORITY|||||||0.003|||||||Fisher Exact|||OCDS: Compulsive||||0.003
71033454|NCT03872128|141576980|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<.0001
71154250|NCT03414684|141801128|SUPERIORITY||Odds Ratio (OR)|1.05||||1|TWO_SIDED|95.0|0.32|3.43|||Fisher Exact||Reference level is Arm B, such that the odds ratio corresponds to treatment on Arm A|||3.43|0.32|1
71095321|NCT01452347|141698887|SUPERIORITY_OR_OTHER||||||<|0.001||||||Probability that P remains \< 10% are presented, where P=Percentage of patients with observed Ctrough,ss value \< 50 ng/mL|Beta Function|Probability calculated using Beta function \~B(1 + r, 1 + n - r),r=no. of patients(observed Ctrough,ss value \< 50 ng/mL), n=no. of patients evaluated||||||<0.001
70921537|NCT04714320|141333625|SUPERIORITY||||||=|0.846||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 22||||=0.846
70921538|NCT04714320|141333625|SUPERIORITY|||||||0.634||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 29||||0.634
70974437|NCT01340209|141455693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.037|STANDARD_ERROR_OF_MEAN|0.053||0.4944|TWO_SIDED|95.0|-0.141|0.068|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 2.5 µg minus placebo||0.068|-0.141|0.4944
70921539|NCT04714320|141333625|SUPERIORITY||||||=|0.767||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 29||||=0.767
70921540|NCT04714320|141333625|SUPERIORITY||||||=|0.399||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 36||||=0.399
70921541|NCT04714320|141333625|SUPERIORITY||||||=|0.323||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 36||||=0.323
70921542|NCT04714320|141333625|SUPERIORITY||||||=|0.115||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 43||||=0.115
70921543|NCT04714320|141333625|SUPERIORITY||||||=|0.982||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 43||||=0.982
70921544|NCT04714320|141333625|SUPERIORITY||||||=|0.859||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 50||||=0.859
70921545|NCT04714320|141333625|SUPERIORITY||||||=|0.344||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 50||||=0.344
70921546|NCT04714320|141333625|SUPERIORITY||||||=|0.633||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 57||||=0.633
70921547|NCT04714320|141333625|SUPERIORITY||||||=|0.889||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 57||||=0.889
70921548|NCT04714320|141333625|SUPERIORITY||||||=|0.241||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 64||||=0.241
70921549|NCT04714320|141333625|SUPERIORITY||||||=|0.367||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 64||||=0.367
70921550|NCT04714320|141333625|SUPERIORITY||||||=|0.716||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 71||||=0.716
70921551|NCT04714320|141333625|SUPERIORITY||||||=|0.21||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 71||||=0.210
70921552|NCT04714320|141333625|SUPERIORITY||||||=|0.363||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 78||||=0.363
70921553|NCT04714320|141333625|SUPERIORITY||||||=|0.193||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 78||||=0.193
70921554|NCT04714320|141333625|SUPERIORITY||||||=|0.135||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 85||||=0.135
70921555|NCT04714320|141333625|SUPERIORITY||||||=|0.867||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 85||||=0.867
70921556|NCT04714320|141333625|SUPERIORITY||||||=|0.761||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 92||||=0.761
70974438|NCT01340209|141455693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.054||0.127|TWO_SIDED|95.0|-0.023|0.188|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 5 μg minus placebo||0.188|-0.023|0.1270
70974439|NCT01340209|141455694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.498|STANDARD_ERROR_OF_MEAN|12.282||0.9677|TWO_SIDED|95.0|-23.634|24.63|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 2.5 µg minus placebo||24.630|-23.634|0.9677
70921557|NCT04714320|141333625|SUPERIORITY||||||=|0.618||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 92||||=0.618
70921558|NCT04714320|141333625|SUPERIORITY||||||=|0.363||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received are included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 106||||=0.363
70921559|NCT04714320|141333625|SUPERIORITY||||||=|0.125||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received are included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 106||||=0.125
70921560|NCT04714320|141333625|SUPERIORITY||||||=|0.435||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 120||||=0.435
70921561|NCT04714320|141333625|SUPERIORITY||||||=|0.413||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 120||||=0.413
70921562|NCT04714320|141333625|SUPERIORITY||||||=|0.658||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 148||||=0.658
70921563|NCT04714320|141333625|SUPERIORITY||||||=|0.275||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 148||||=0.275
70921564|NCT04714320|141333625|SUPERIORITY||||||=|0.578||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 169||||=0.578
70921565|NCT04714320|141333625|SUPERIORITY||||||=|0.114||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 169||||=0.114
70921566|NCT04714320|141333626|SUPERIORITY||||||=|0.378||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 8||||=0.378
70921567|NCT04714320|141333626|SUPERIORITY||||||=|0.648||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 8||||=0.648
70921568|NCT04714320|141333626|SUPERIORITY||||||=|0.961||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 15||||=0.961
70921569|NCT04714320|141333626|SUPERIORITY||||||=|0.817||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 15||||=0.817
70921570|NCT04714320|141333626|SUPERIORITY||||||=|0.823||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 22||||=0.823
70921571|NCT04714320|141333626|SUPERIORITY||||||=|0.362||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 22||||=0.362
70921572|NCT04714320|141333626|SUPERIORITY||||||=|0.66||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 29||||=0.660
71033455|NCT03872128|141576981|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||HADS-Depression||||<0.001
70921573|NCT04714320|141333626|SUPERIORITY||||||=|0.539||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 29||||=0.539
70921574|NCT04714320|141333626|SUPERIORITY||||||=|0.43||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 36||||=0.430
70921575|NCT04714320|141333626|SUPERIORITY||||||=|0.594||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 36||||=0.594
71033456|NCT03872128|141576981|SUPERIORITY|||||||0.089|||||||Fisher Exact|||HADS-Anxiety||||0.089
71033457|NCT00556322|141576983|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.7299|TWO_SIDED|95.0|0.78|1.19|||Log Rank|||||1.19|0.78|0.7299
71033458|NCT00556322|141576986|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.6198|TWO_SIDED|95.0|0.72|1.21|||Log Rank|||Comparison of EGFR positive populations||1.21|0.72|0.6198
71033459|NCT00556322|141576986|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.95||||0.8398|TWO_SIDED|95.0|0.55|1.62|||Log Rank|||Comparison of EGFR negative populations||1.62|0.55|0.8398
71033460|NCT00556322|141576989|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.0885|TWO_SIDED|95.0|0.97|1.46|||Log Rank|||||1.46|0.97|0.0885
71033461|NCT00556322|141576992|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26||||0.0662|TWO_SIDED|95.0|0.98|1.61|||Log Rank|||Comparison of EGFR positive populations||1.61|0.98|0.0662
71033462|NCT00556322|141576992|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.9403|TWO_SIDED|95.0|0.61|1.69|||Log Rank|||Comparison of EGFR negative populations||1.69|0.61|0.9403
71033463|NCT00556322|141576994|SUPERIORITY_OR_OTHER||Difference in Response Rates|1.55||||0.5349|TWO_SIDED|95.0|-3.6|6.7||p-values are based on non-stratified analysis|Chi-squared||Approximate 95% CI for the difference of two rates was determined using Hauck-Anderson Method|||6.7|-3.6|0.5349
71033464|NCT00556322|141576996|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||0.1498|TWO_SIDED|95.0|0.93|1.59|||Log Rank|||||1.59|0.93|0.1498
71095322|NCT01452347|141698888|SUPERIORITY_OR_OTHER|||||||0.05||||||Probability that P remains \< 10% are presented, where P=Percentage of patients with observed Ctrough,ss value \< 50 ng/mL|Beta Function|Probability calculated using Beta function \~B(1 + r, 1 + n - r),r=no. of patients(observed Ctrough,ss value \< 50 ng/mL), n=no. of patients evaluated||||||0.05
71095323|NCT01452347|141698889|SUPERIORITY_OR_OTHER|||||||0.46||||||Probability that P remains \< 10% are presented, where P=Percentage of patients with observed Ctrough,ss value \< 50 ng/mL|Beta Function|Probability calculated using Beta function \~B(1 + r, 1 + n - r),r=no. of patients(observed Ctrough,ss value \< 50 ng/mL), n=no. of patients evaluated||||||0.46
71095324|NCT01452347|141698890|SUPERIORITY_OR_OTHER|||||||0.65||||||Probability that P remains \< 10% are presented, where P=Percentage of patients with observed Ctrough,ss value \< 50 ng/mL|Beta Function|Probability calculated using Beta function \~B(1 + r, 1 + n - r),r=no. of patients(observed Ctrough,ss value \< 50 ng/mL), n=no. of patients evaluated||||||0.65
71154251|NCT03414684|141801129|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.36|TWO_SIDED|95.0|0.13|2.12|||Log Rank||Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A|||2.12|0.13|0.36
71154252|NCT03414684|141801130|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.68|TWO_SIDED|95.0|0.43|3.43|||Log Rank||Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A|||3.43|0.43|0.68
71154253|NCT03414684|141801131|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.27|TWO_SIDED|95.0|0.18|1.62|||Log Rank|stratified log rank test|Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A|||1.62|0.18|0.27
71154254|NCT03414684|141801132|SUPERIORITY||Odds Ratio (OR)|0.81||||1|TWO_SIDED|95.0|0.08|7.78|||Fisher Exact||Reference level is Arm B, such that the odds ratio corresponds to treatment on Arm A|||7.78|0.08|1
71154255|NCT03414684|141801134|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.61|TWO_SIDED|95.0|0.26|2.16|||Log Rank|stratified log rank test|Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A|||2.16|0.26|0.61
71154256|NCT03414684|141801135|SUPERIORITY||Odds Ratio (OR)|0.79||||1|TWO_SIDED|95.0|0.1|5.93|||Fisher Exact||Reference level is Arm B, such that the odds ratio corresponds to treatment on Arm A|||5.93|0.10|1
71154257|NCT03414684|141801137|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.73|TWO_SIDED|95.0|0.14|3.89|||Log Rank||Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A|||3.89|0.14|0.73
70974440|NCT01340209|141455694|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|34.176|STANDARD_ERROR_OF_MEAN|12.346||0.0058|TWO_SIDED|95.0|9.919|58.432|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium Respimat 5 μg minus placebo||58.432|9.919|0.0058
70974441|NCT01340209|141455695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.646|STANDARD_ERROR_OF_MEAN|9.182||0.3468|TWO_SIDED|95.0|-9.388|26.68|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 2.5 µg minus placebo||26.680|-9.388|0.3468
70974442|NCT01340209|141455695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.216|STANDARD_ERROR_OF_MEAN|9.238||0.5013||95.0|-11.927|24.359|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 5 μg minus placebo||24.359|-11.927|0.5013
71154258|NCT04038580|141801152|SUPERIORITY|||||||0.553||||||Statistical significance was set a-priori at p\<0.05|ANOVA|||The null hypothesis was that all sockets would have the same SCS||||0.553
71154259|NCT04038580|141801153|SUPERIORITY|Frustration sub-scale||||||0.536|||||||ANOVA|||The null hypothesis was that all sockets would be the same||||0.536
71154260|NCT04038580|141801153|SUPERIORITY|Perceived Response||||||0.598|||||||ANOVA|||||||0.598
71154261|NCT04038580|141801153|SUPERIORITY|Social Burden||||||0.072|||||||ANOVA|||||||0.072
71154262|NCT04038580|141801153|SUPERIORITY|Ambulation Sub-scale||||||0.018|||||||ANOVA|||||||0.018
71154263|NCT04038580|141801153|SUPERIORITY|Prosthesis Utility||||||0.037|||||||ANOVA|||||||0.037
71154264|NCT04038580|141801153|SUPERIORITY|Residual Limb Health||||||0.254|||||||ANOVA|||||||0.254
71154265|NCT04038580|141801153|SUPERIORITY|Appearance||||||0.032|||||||ANOVA|||||||0.032
70974443|NCT01340209|141455696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.458|STANDARD_ERROR_OF_MEAN|9.196||0.2132|TWO_SIDED|95.0|-6.601|29.517|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 2.5 µg minus placebo||29.517|-6.601|0.2132
70974444|NCT01340209|141455696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.398|STANDARD_ERROR_OF_MEAN|9.245||0.0766|TWO_SIDED|95.0|-1.759|34.555|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 5 μg minus placebo||34.555|-1.759|0.0766
70974445|NCT01340209|141455697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.601|STANDARD_ERROR_OF_MEAN|1.038||0.5629|TWO_SIDED|95.0|-2.637|1.436|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 2.5 µg minus placebo||1.436|-2.637|0.5629
70974446|NCT01340209|141455697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.564|STANDARD_ERROR_OF_MEAN|1.038||0.5871|TWO_SIDED|95.0|-1.473|2.601|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 5 μg minus placebo||2.601|-1.473|0.5871
71154266|NCT04038580|141801153|SUPERIORITY|Sounds||||||0.352|||||||ANOVA|||||||0.352
71154267|NCT04038580|141801153|SUPERIORITY|Well-being||||||0.077|||||||ANOVA|||||||.077
71154268|NCT04038580|141801154|SUPERIORITY|||||||0.95|||||||ANOVA|general linear model with socket as fixed factor and participant as random factor||||||0.95
71154269|NCT04038580|141801155|SUPERIORITY|||||||0.853|||||||ANOVA|general linear model with sockets as fixed effect and subjects as random effect||||||.853
71154270|NCT04038580|141801156|SUPERIORITY|||||||0.565|||||||ANOVA|general linear model with socket as a fixed factor and subjects as a random factor||||||0.565
71154271|NCT04038580|141801158|SUPERIORITY|||||||0.374|||||||ANOVA|general linear model with socket as fixed factor and subjects as random factor||||||.374
71154272|NCT04038580|141801160|SUPERIORITY|||||||0.574|||||||ANOVA|general linear model with socket as a fixed factor and subjects as a random factor||||||.574
70974447|NCT02475655|141455724|SUPERIORITY|||||||0.67||||||Not adjusted for multiple comparisons. One-sided 5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in the percentage of participants experiencing safety milestones from Entry to Week 5.||||0.67
71033465|NCT00556322|141576999|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.2202|TWO_SIDED|95.0|0.9|1.57|||Log Rank|||||1.57|0.90|0.2202
71033466|NCT00556322|141577002|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.1063|TWO_SIDED|95.0|0.95|1.66|||Log Rank|||||1.66|0.95|0.1063
71033467|NCT03733444|141577004|SUPERIORITY||Least Squares (LS) Mean difference|2.8|STANDARD_ERROR_OF_MEAN|25.29||0.9123|TWO_SIDED|95.0|-46.9|52.4||P-value was based on random coefficient regression model (linear slope model) on FVC values.|Coefficient Regression Model|Treatment effect was determined by using estimated slopes for each treatment group on basis of time-by-treatment interaction term from mixed model.||||52.4|-46.9|0.9123
71033468|NCT03733444|141577004|SUPERIORITY||LS Mean difference|1.7|STANDARD_ERROR_OF_MEAN|25.01||0.9456|TWO_SIDED|95.0|-47.4|50.8||P-value was based on random coefficient regression model (linear slope model) on FVC values.|Coefficient Regression Model|Treatment effect was determined by using estimated slopes for each treatment group on basis of time-by-treatment interaction term from mixed model.||||50.8|-47.4|0.9456
70921576|NCT04714320|141333626|SUPERIORITY||||||=|0.783||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 43||||=0.783
70921577|NCT04714320|141333626|SUPERIORITY||||||=|0.599||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 43||||=0.599
70921578|NCT04714320|141333626|SUPERIORITY||||||=|0.454||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 50||||=0.454
70921579|NCT04714320|141333626|SUPERIORITY||||||=|0.394||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 50||||=0.394
70921580|NCT04714320|141333626|SUPERIORITY||||||=|0.93||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 57||||=0.930
70921581|NCT04714320|141333626|SUPERIORITY||||||=|0.313||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 57||||=0.313
70921582|NCT04714320|141333626|SUPERIORITY||||||=|0.276||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 64||||=0.276
70921583|NCT04714320|141333626|SUPERIORITY||||||=|0.168||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 64||||=0.168
70921584|NCT04714320|141333626|SUPERIORITY||||||=|0.199||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 71||||=0.199
70921585|NCT04714320|141333626|SUPERIORITY||||||=|0.506||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 71||||=0.506
70921586|NCT04714320|141333626|SUPERIORITY||||||=|0.32||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 78||||=0.320
70921587|NCT04714320|141333626|SUPERIORITY||||||=|0.25||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 78||||=0.250
70921588|NCT04714320|141333626|SUPERIORITY||||||=|0.373||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 85||||=0.373
70921589|NCT04714320|141333626|SUPERIORITY||||||=|0.597||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 85||||=0.597
70921590|NCT04714320|141333626|SUPERIORITY||||||=|0.867||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 92||||=0.867
70921591|NCT04714320|141333626|SUPERIORITY||||||=|0.5||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 92||||=0.500
70921592|NCT04714320|141333626|SUPERIORITY||||||=|0.863||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 106||||=0.863
70921593|NCT04714320|141333626|SUPERIORITY||||||=|0.681||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 106||||=0.681
70921594|NCT04714320|141333626|SUPERIORITY||||||=|0.262||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 120||||=0.262
70921595|NCT04714320|141333626|SUPERIORITY||||||=|0.645||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 120||||=0.645
70921596|NCT04714320|141333626|SUPERIORITY||||||=|0.947||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 148||||=0.947
70921597|NCT04714320|141333626|SUPERIORITY||||||=|0.665||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 148||||=0.665
70921598|NCT04714320|141333626|SUPERIORITY||||||=|0.498||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 169||||=0.498
70921599|NCT04714320|141333626|SUPERIORITY||||||=|0.173||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 169||||=0.173
70921600|NCT05057897|141333631|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|GMT Ratio|0.73|||||TWO_SIDED|95.0|0.18|3.01|||||The GMT ratio was calculated as the ratio of the titer levels in the immunocompromised cohort to the immunocompetent cohort.|Day 57 (28 days post Dose 2)||3.01|0.18|
70921601|NCT05057897|141333632|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|Difference in Seroresponse|-30.36|||||TWO_SIDED|95.0|-62.82|3.69||||The 2-sided 95% CI was calculated using the Newcombe score without continuity correction.|The difference in seroresponse 28 days post Dose 2 of AZD1222 was calculated as (seroresponse rate of immunocompromised cohort) - (seroresponse rate of immunocompetent cohort).|Day 57 (28 days post Dose 2)||3.69|-62.82|
70921602|NCT05057897|141333633|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|GMT Ratio|0.47|||||TWO_SIDED|95.0|0.06|3.86|||||The GMT ratio was calculated as the ratio of the titer levels in the immunocompromised cohort to the immunocompetent cohort.|Day 57 (28 days post Dose 2)||3.86|0.06|
70921603|NCT05057897|141333634|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|Difference in Seroresponse|-25.0|||||TWO_SIDED|95.0|-59.07|2.97||||The 2-sided 95% CI was calculated using the Newcombe score without continuity correction.|The difference in seroresponse 28 days post Dose 2 of AZD1222 was calculated as (seroresponse rate of immunocompromised cohort) - (seroresponse rate of immunocompetent cohort).|Day 57 (28 days post Dose 2)||2.97|-59.07|
70921604|NCT05057897|141333635|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|GMT Ratio|0.32|||||TWO_SIDED|95.0|0.12|0.8|||||The GMT ratio was calculated as the ratio of the titer levels in the immunocompromised cohort to the immunocompetent cohort.|Day 85 Immunocompromised / Day 211 Immunocompetent (28 days post Dose 3)||0.80|0.12|
70921605|NCT05057897|141333636|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|Difference in Seroresponse|0.0||||||||||||Due to everyone in both cohorts being a seroresponder, the confidence interval (CI) around the difference is not estimable.|The difference in seroresponse 28 days post Dose 3 of AZD1222 was calculated as (seroresponse rate of immunocompromised cohort) - (seroresponse rate of immunocompetent cohort).|Day 85 Immunocompromised / Day 211 Immunocompetent (28 days post Dose 3)||||
70921606|NCT05057897|141333637|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|GMT Ratio|0.56|||||TWO_SIDED|95.0|0.25|1.25|||||The GMT ratio was calculated as the ratio of the titer levels in the immunocompromised cohort to the immunocompetent cohort.|Day 85 Immunocompromised / Day 211 Immunocompetent (28 days post Dose 3)||1.25|0.25|
70974448|NCT02475655|141455727|SUPERIORITY||Mean Difference (Net)|0.85||||0.18|TWO_SIDED|90.0|0.69|1.04||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Plasma Interleukin 6 (IL-6) from baseline to week 4/5.||1.04|0.69|0.18
70974449|NCT02475655|141455729|SUPERIORITY|||||||0.4||||||Not adjusted for multiple comparisons. One-sided 5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in the percentage of participants experiencing safety milestones from Entry to Week 12.||||0.40
71033469|NCT03733444|141577005|SUPERIORITY||Odds Ratio (OR)|1.15||||0.5162|TWO_SIDED|95.0|0.76|1.74|||Regression, Logistic|||||1.74|0.76|0.5162
71033470|NCT03733444|141577005|SUPERIORITY||Odds Ratio (OR)|1.07||||0.7566|TWO_SIDED|95.0|0.71|1.62|||Regression, Logistic|||||1.62|0.71|0.7566
71033471|NCT03733444|141577006|SUPERIORITY||Hazard Ratio (HR)|2.15|||||TWO_SIDED|95.0|1.2|3.85|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first respiratory-related hospitalization.|||3.85|1.20|
71033472|NCT03733444|141577006|SUPERIORITY||Hazard Ratio (HR)|1.69|||||TWO_SIDED|95.0|0.93|3.1|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first respiratory-related hospitalization.|||3.10|0.93|
71095325|NCT02642679|141698891|OTHER|We set alpha=0.05/3=0.17 to account for multiple outcomes for sample size and power calculations. With 10 patients in each group, we had 95% power to detect an improvement of 2 points in VAS score assuming a common standard deviation of 1 point with a two sided two sample t-test each at alpha=0.17 level.|||||||||||||||||A student t-test was used for correlated samples to determine if there were significant differences in pain. Microsoft Excel 2010 (Microsoft Corp., Redmond, WA) was used for statistical analysis. Data that were considered normally distributed are reported as the mean ± standard deviation (SD) and percentage. P-values \<0.05 were considered significant.|||
71095326|NCT02642679|141698892|OTHER|We set alpha=0.05/3=0.17 to account for multiple outcomes for sample size and power calculations. With 10 patients in each group, we will have 80% power to detect an improvement in re-epithelialization from 14.6 days to 10 days assuming a common standard deviation of 2.9 days.|||||||||||||||||A student t-test was used for correlated samples to determine if there were significant differences in healing rate. Microsoft Excel 2010 (Microsoft Corp., Redmond, WA) was used for statistical analysis. Data that were considered normally distributed are reported as the mean ± standard deviation (SD) and percentage. P-values \<0.05 were considered significant.|||
71095327|NCT02642679|141698893|OTHER|We set alpha=0.05/3=0.17 to account for multiple outcomes for sample size and power calculations. With 10 patients in each group, we will have 95% power to detect an improvement of 2 points in VSS score assuming a common standard deviation of 1 point.|||||||||||||||||A student t-test was used for correlated samples to determine if there were significant differences in healing quality. Microsoft Excel 2010 (Microsoft Corp., Redmond, WA) was used for statistical analysis. Data that were considered normally distributed are reported as the mean ± standard deviation (SD) and percentage. P-values \<0.05 were considered significant.|||
71095328|NCT01112267|141698896|SUPERIORITY_OR_OTHER|||||||0.0367|||||||Cochran-Mantel-Haenszel|p-value for percentage of participants with reduction in pain intensity was calculated for tramadol HCl/acetaminophen and placebo groups||||||0.0367
71095329|NCT01112267|141698897|SUPERIORITY_OR_OTHER|||||||0.0095||||||p-value for change in reduction in pain intensity at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups|Mann-Whitney U test|||||||0.0095
71095330|NCT01112267|141698898|SUPERIORITY_OR_OTHER|||||||0.0202||||||p-value for percentage of participants with pain relief at Day 8 was calculated for tramadol HCl/acetaminophen and placebo groups|Chi-squared|||||||0.0202
71095331|NCT01112267|141698898|SUPERIORITY_OR_OTHER|||||||0.0102||||||p-value for percentage of participants with pain relief at Day 15 was calculated for tramadol HCl/acetaminophen and placebo groups|Chi-squared|||||||0.0102
70974450|NCT02475655|141455733|SUPERIORITY||Mean Difference (Net)|1.31||||0.7|TWO_SIDED|90.0|-4.27|6.9||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in creatinine clearance from Entry to Week 1/2.||6.90|-4.27|0.70
70974451|NCT02475655|141455733|SUPERIORITY||Mean Difference (Net)|1.61||||0.69|TWO_SIDED|90.0|-5.06|8.29||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in creatinine clearance from Entry to Week 4/5.||8.29|-5.06|0.69
70974452|NCT02475655|141455733|SUPERIORITY||Mean Difference (Net)|6.35||||0.09|TWO_SIDED|90.0|0.16|12.5||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.||Null hypothesis: There is no difference between the two arms in the change in creatinine clearance from Entry to 10/12.||12.5|0.16|0.09
70974453|NCT02475655|141455735|SUPERIORITY||Mean Difference (Net)|-0.02||||0.58|TWO_SIDED|90.0|-0.06|0.03||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in creatinine from Entry to Week 1/2.||0.03|-0.06|0.58
70974454|NCT02475655|141455735|SUPERIORITY||Mean Difference (Net)|-0.01||||0.79|TWO_SIDED|90.0|-0.06|0.04||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in creatinine from Entry to Week 4/5.||0.04|-0.06|0.79
71095332|NCT01112267|141698898|SUPERIORITY_OR_OTHER|||||||0.4652||||||p-value for percentage of participants with pain relief at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups|Chi-squared|||||||0.4652
70974455|NCT02475655|141455735|SUPERIORITY||Mean Difference (Net)|-0.07||||0.016|TWO_SIDED|90.0|-0.11|-0.02||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in creatinine from Entry to 10/12.||-0.02|-0.11|0.016
70974456|NCT02475655|141455737|SUPERIORITY||Mean Difference (Net)|-679.0||||0.018|TWO_SIDED|90.0|-1146.0|-212.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean|Null hypothesis: There is no difference between the two arms in the change in absolute neutrophil count (ANC) from Entry to Week 1/2.||-212|-1146|0.018
71095333|NCT01112267|141698899|SUPERIORITY_OR_OTHER|||||||0.3524||||||p-value for change from Baseline in physical conditioning at Day 29 was calculated using for tramadol HCl/acetaminophen and placebo groups|Wilcoxon (Mann-Whitney)|||||||0.3524
71095334|NCT01112267|141698899|SUPERIORITY_OR_OTHER|||||||0.0224||||||p-value for change from Baseline in role physical at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.0224
70974457|NCT02475655|141455737|SUPERIORITY||Mean Difference (Net)|-651.0||||0.021|TWO_SIDED|90.0|-1110.0|-192.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in absolute neutrophil count (ANC) from Entry to Week 4/5.||-192|-1110|0.021
70974458|NCT02475655|141455737|SUPERIORITY||Mean Difference (Net)|33.6||||0.91|TWO_SIDED|90.0|-461.0|528.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in absolute neutrophil count (ANC) from Entry to Week 10/12.||528|-461|0.91
71095335|NCT01112267|141698899|SUPERIORITY_OR_OTHER|||||||0.5712||||||p-value for change from Baseline in bodily pain at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.5712
70921607|NCT05057897|141333638|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|Difference in Seroresponse|0.0||||||||||||Due to everyone in both cohorts being a seroresponder, the confidence interval (CI) around the difference is not estimable.|The difference in seroresponse 28 days post Dose 3 of AZD1222 was calculated as (seroresponse rate of immunocompromised cohort) - (seroresponse rate of immunocompetent cohort).|Day 85 Immunocompromised / Day 211 Immunocompetent (28 days post Dose 3)||||
70921608|NCT04524390|141333665|SUPERIORITY||Least-Square mean|-0.39|STANDARD_ERROR_OF_MEAN|1.182||0.7419|TWO_SIDED|95.0|-2.76|1.97|||MMRM|||||1.97|-2.76|0.7419
70921609|NCT04524390|141333666|SUPERIORITY||Least-Square mean|-45.9|STANDARD_ERROR_OF_MEAN|35.398||0.2002|TWO_SIDED|95.0|-116.86|25.05|||MMRM|||||25.05|-116.86|0.2002
70921610|NCT04524390|141333667|SUPERIORITY|||||||0.8412|||||||Barnard's exact test|||||||0.8412
70921611|NCT04524390|141333668|SUPERIORITY||||||>|0.9999|||||||Barnard's exact test|||||||> 0.9999
70921612|NCT04524390|141333669|SUPERIORITY|||||||0.6658|||||||Barnard's exact test|||||||0.6658
70921613|NCT04524390|141333670|SUPERIORITY|||||||0.6236|||||||Barnard's exact test|||||||0.6236
70921614|NCT04524390|141333671|SUPERIORITY|||||||0.6658|||||||Barnard's exact test|||||||0.6658
70921615|NCT04524390|141333672|SUPERIORITY|||||||0.6659|||||||Barnard's exact test|||||||0.6659
70921616|NCT05930782|141333673|EQUIVALENCE|The treatment was considered as bioequivalent if the 90% confidence interval (CI) for geometric least square mean ratios (GMR) of Cmax falls within the acceptance range of 80.00 % to 125.00 %.|geometric least square mean ratios (GMR)|73.9|||||TWO_SIDED|90.0|48.32|113.02||||||||113.02|48.32|
70921617|NCT05930782|141333674|EQUIVALENCE|The treatment was considered as bioequivalent if the 90% confidence interval (CI) for geometric least square mean ratios (GMR) of ln-transformed parameters falls within the acceptance range of 80.00 % to 125.00 %.|geometric least square mean ratio (GMR)|75.41|||||TWO_SIDED|90.0|56.46|100.71||||||||100.71|56.46|
70921618|NCT05930782|141333675|EQUIVALENCE|The treatment was considered as bioequivalent if the 90% confidence interval (CI) for geometric least square mean ratios (GMR) of ln-transformed parameters falls within the acceptance range of 80.00 % to 125.00 %.|geometric least square mean ratios (GMR)|86.45|||||TWO_SIDED|90.0|68.16|109.63||||||||109.63|68.16|
70921619|NCT05930782|141333676|EQUIVALENCE|The treatment was considered as bioequivalent if the 90% confidence interval (CI) for geometric least square mean ratios (GMR) of ln-transformed parameters falls within the acceptance range of 80.00 % to 125.00 %.|geometric least square mean ratios (GMR)|77.67|||||TWO_SIDED|90.0|59.49|101.39||||||||101.39|59.49|
70921620|NCT05930782|141333677|EQUIVALENCE|The treatment was considered as bioequivalent if the 90% confidence interval (CI) for geometric least square mean ratios (GMR) of ln-transformed parameters falls within the acceptance range of 80.00 % to 125.00 %.|geometric least square mean ratios (GMR)|55.24|||||TWO_SIDED|90.0|6.03|113.02|||||For AUC0-inf, the GMR and 90% CI values were unreliable as there was only 1 calculable value for the Test (Group 2) and 2 values for the Reference (Group 1) products.|||113.02|6.03|
70921621|NCT00792636|141333701|SUPERIORITY_OR_OTHER||Least-squares mean|-1.7|||||TWO_SIDED|95.0|-3.2|-0.3|||||Systolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||-0.3|-3.2|
70921622|NCT00792636|141333701|SUPERIORITY_OR_OTHER||Least-squares mean|-0.9|||||TWO_SIDED|95.0|-2.2|0.3|||||Diastolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||0.3|-2.2|
71095336|NCT01112267|141698899|SUPERIORITY_OR_OTHER|||||||0.0395||||||p-value for change from Baseline in general health at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.0395
70921623|NCT00792636|141333701|SUPERIORITY_OR_OTHER||Least-squares mean|-1.9|||||TWO_SIDED|95.0|-3.4|-0.4|||||Systolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||-0.4|-3.4|
70921624|NCT00792636|141333701|SUPERIORITY_OR_OTHER||Least-squares mean|-0.7|||||TWO_SIDED|95.0|-2.0|0.6|||||Diastolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||0.6|-2.0|
70921625|NCT00792636|141333702|SUPERIORITY_OR_OTHER||Least-squares mean|-2.1|||||TWO_SIDED|95.0|-3.4|-0.8|||||Systolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||-0.8|-3.4|
70921626|NCT00792636|141333702|SUPERIORITY_OR_OTHER||Least-squares mean|-1.5|||||TWO_SIDED|95.0|-2.6|-0.3|||||Diastolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||-0.3|-2.6|
70921627|NCT00792636|141333703|SUPERIORITY_OR_OTHER||Least-squares mean|0.4|||||TWO_SIDED|95.0|-1.6|2.4|||||Systolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||2.4|-1.6|
70921628|NCT00792636|141333703|SUPERIORITY_OR_OTHER||Least-squares mean|0.5|||||TWO_SIDED|95.0|-1.2|2.2|||||Diastolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||2.2|-1.2|
70921629|NCT00792636|141333704|SUPERIORITY_OR_OTHER||Least-squares mean|0.3|||||TWO_SIDED|95.0|-1.7|2.2|||||Systolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||2.2|-1.7|
70921630|NCT00792636|141333704|SUPERIORITY_OR_OTHER||Least-squares mean|0.8|||||TWO_SIDED|95.0|-0.9|2.5|||||Diastolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||2.5|-0.9|
70921631|NCT00792636|141333709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|0.9|2.6||||||||2.6|0.9|
70921632|NCT00792636|141333709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|0.9|2.6||||||||2.6|0.9|
70921633|NCT00792636|141333710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.6|1.7||||||||1.7|0.6|
70921634|NCT00792636|141333710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|0.7|2.2||||||||2.2|0.7|
70921635|NCT00792636|141333711|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.1|13.6||||||||13.6|0.1|
70921636|NCT00792636|141333711|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.8|||||TWO_SIDED|95.0|0.3|25.6||||||||25.6|0.3|
70921637|NCT00792636|141333712|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.5|3.7||||||||3.7|0.5|
70921638|NCT00792636|141333712|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||||TWO_SIDED|95.0|0.6|4.2||||||||4.2|0.6|
70921639|NCT00792636|141333713|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.84|1.54||||||||1.54|0.84|
70921640|NCT00792636|141333713|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.36|||||TWO_SIDED|95.0|1.01|1.83||||||||1.83|1.01|
70921641|NCT00792636|141333714|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.65|1.21||||||||1.21|0.65|
70921642|NCT00792636|141333714|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.88|1.6||||||||1.60|0.88|
70921643|NCT02590432|141333730|SUPERIORITY||Odds Ratio (OR)|1.3||||1|TWO_SIDED|95.0|0.3|5.5|||Fisher's Exact Test|||LINZESS® 145 μg versus (vs) LINZESS® 290 μg||5.5|0.3|1.0000
70921644|NCT02590432|141333730|SUPERIORITY||Odds Ratio (OR)|0.2||||0.0844|TWO_SIDED|95.0|0.1|1.1|||Fisher's Exact Test|||LINZESS® 72 μg vs LINZESS® 290 μg||1.1|0.1|0.0844
70921645|NCT02590432|141333730|SUPERIORITY||Odds Ratio (OR)|0.9||||1|TWO_SIDED|95.0|0.3|2.5|||Fisher's Exact Test|||LINZESS® 72 μg vs LINZESS® 145 μg||2.5|0.3|1.0000
70921646|NCT02590432|141333731|SUPERIORITY||Odds Ratio (OR)|1.3||||1|TWO_SIDED|95.0|0.3|5.1|||Fisher's Exact Test|||LINZESS® 145 μg vs LINZESS® 290 μg||5.1|0.3|1.0000
70974459|NCT02475655|141455739|SUPERIORITY||Mean Difference (Net)|-0.13||||0.45|TWO_SIDED|90.0|-0.42|0.15||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in hemoglobin from Entry to Week 1/2.||0.15|-0.42|0.45
70974460|NCT02475655|141455739|SUPERIORITY||Mean Difference (Net)|-0.55||||0.005|TWO_SIDED|90.0|-0.87|-0.23||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in hemoglobin from Entry to Week 4/5.||-0.23|-0.87|0.005
70974461|NCT02475655|141455739|SUPERIORITY||Mean Difference (Net)|0.15||||0.75|TWO_SIDED|90.0|-0.65|0.95||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in hemoglobin from Entry to Week 10/12.||0.95|-0.65|0.75
71033473|NCT03733444|141577007|SUPERIORITY||LS Mean difference|-0.1||||0.937|TWO_SIDED|95.0|-3.2|3.0||LS mean difference (95% CI) per treatment group with treatment, time (categorical), treatment-by-time interaction, stratum and baseline SGRQ total score as fixed effects and participant as random effect.|Mixed Models Analysis|||||3.0|-3.2|0.9370
70921647|NCT02590432|141333731|SUPERIORITY||Odds Ratio (OR)|0.2||||0.0799|TWO_SIDED|95.0|0.1|1.0|||Fisher's Exact Test|||LINZESS® 72 μg vs LINZESS® 290 μg||1.0|0.1|0.0799
70921648|NCT02590432|141333731|SUPERIORITY||Odds Ratio (OR)|0.7||||0.7871|TWO_SIDED|95.0|0.3|2.2|||Fisher's Exact Test|||LINZESS® 72 μg vs LINZESS® 145 μg||2.2|0.3|0.7871
70921649|NCT02590432|141333733|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.993|TWO_SIDED|95.0|0.42|2.19|||Log-Rank Test|||LINZESS® 145 μg vs LINZESS® 290 μg||2.19|0.42|0.9930
70921650|NCT02590432|141333733|SUPERIORITY||Hazard Ratio (HR)|0.31||||0.0247|TWO_SIDED|95.0|0.11|0.89|||Log-Rank Test|||LINZESS® 72 μg vs LINZESS® 290 μg||0.89|0.11|0.0247
70921651|NCT02590432|141333733|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.5149|TWO_SIDED|95.0|0.41|1.5|||Log-Rank Test|||LINZESS® 72 μg vs LINZESS® 145 μg||1.50|0.41|0.5149
70921652|NCT02590432|141333734|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.9519|TWO_SIDED|95.0|0.39|2.18|||Log-Rank Test|||LINZESS® 145 μg vs LINZESS® 290 μg||2.18|0.39|0.9519
70921653|NCT02590432|141333734|SUPERIORITY||Hazard Ratio (HR)|0.27||||0.0234|TWO_SIDED|95.0|0.08|0.87|||Log-Rank Test|||LINZESS® 72 μg vs LINZESS® 290 μg||0.87|0.08|0.0234
70921654|NCT02590432|141333734|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.4518|TWO_SIDED|95.0|0.39|1.47|||Log-Rank Test|||LINZESS® 72 μg vs LINZESS® 145 μg||1.47|0.39|0.4518
70921655|NCT02740231|141333764|SUPERIORITY||Adjusted mean difference|-9.49|STANDARD_DEVIATION|6.38||0.141|TWO_SIDED|95.0|-22.21|3.23||The threshold for statistical significance was p=0.05|ANCOVA||Difference between groups JTA-004 100 (2mL) minus Reference - adjusted mean change|The primary endpoint is the WOMAC® VA3.1 Pain Subscale (subscale A): the individual changes in WOMAC® VA3.1 Pain Subscale Score between Baseline and Month 6 were calculated and compared by analysis of covariance (ANCOVA), adjusted for baseline value, to the Reference group.||3.23|-22.21|0.141
70921656|NCT02740231|141333765|SUPERIORITY||Adjusted mean difference|-11.63|STANDARD_DEVIATION|5.5||0.038|TWO_SIDED|95.0|-22.6|-0.66||The threshold for statistical significance was p=0.05|ANCOVA||Difference between groups JTA-004 100 (2mL) minus Reference|||-0.66|-22.60|0.038
70921657|NCT02740231|141333766|SUPERIORITY||Adjusted mean difference|-1.48|STANDARD_DEVIATION|4.35||0.997|TWO_SIDED|95.0|-12.7|9.74||The threshold for statistical significance was p=0.05|Mixed Models Analysis|||||9.74|-12.70|0.997
70921658|NCT02740231|141333767|SUPERIORITY||Adjusted mean difference|-2.94|STANDARD_DEVIATION|5.3||0.972|TWO_SIDED|95.0|-16.52|10.65||The threshold for statistical significance was p=0.05|Mixed Models Analysis|||||10.65|-16.52|0.972
70921659|NCT02740231|141333768|SUPERIORITY||Adjusted mean difference|-7.17|STANDARD_DEVIATION|5.96||0.599|TWO_SIDED|95.0|-22.28|7.94||The threshold for statistical significance was p=0.05|Mixed Models Analysis|||||7.94|-22.28|0.599
70921660|NCT02740231|141333769|SUPERIORITY||Adjusted mean difference|-6.62|STANDARD_DEVIATION|4.3||0.126|TWO_SIDED|95.0||||The threshold for statistical significance was p=0.05|ANCOVA|||||||0.126
70921661|NCT02740231|141333770|SUPERIORITY||Adjusted mean difference|-8.88|STANDARD_DEVIATION|4.76||0.064|TWO_SIDED|95.0||||The threshold for statistical significance was p=0.05|ANCOVA|||||||0.064
70921662|NCT02740231|141333771|SUPERIORITY||Adjusted mean difference|-10.79|STANDARD_DEVIATION|4.35||0.014|TWO_SIDED|95.0|||||ANCOVA|||||||0.014
70921663|NCT02740231|141333772|SUPERIORITY||Adjusted mean difference|-10.57|STANDARD_DEVIATION|4.81||0.03|TWO_SIDED|95.0||||The threshold for statistical significance was p=0.05|ANCOVA|||||||0.030
70921664|NCT00999167|141333813|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0354|TWO_SIDED|95.0|||||Poisson regression adjusting for country|||||||0.0354
71095337|NCT01112267|141698899|SUPERIORITY_OR_OTHER|||||||0.0524||||||p-value for change from Baseline in vitality at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.0524
71095338|NCT01112267|141698899|SUPERIORITY_OR_OTHER|||||||0.115||||||p-value for change from Baseline in social functioning at Day 29 was calculated using for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.115
71095339|NCT01112267|141698899|SUPERIORITY_OR_OTHER|||||||0.7788||||||p-value for change from Baseline in role emotional at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.7788
71095340|NCT01112267|141698899|SUPERIORITY_OR_OTHER|||||||0.7776||||||p-value for change from Baseline in mental health at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.7776
71095341|NCT01112267|141698899|SUPERIORITY_OR_OTHER|||||||0.0047||||||p-value for change from Baseline in Reptd. health transition at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.0047
71095342|NCT01112267|141698900|SUPERIORITY_OR_OTHER|||||||0.0527||||||p-value for change from Baseline in ODI- Korean version at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.0527
71095343|NCT01112267|141698901|SUPERIORITY_OR_OTHER|||||||0.0917||||||p-value for investigator's global assessment on investigational product at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Chi-squared|||||||0.0917
71095344|NCT01112267|141698902|SUPERIORITY_OR_OTHER|||||||0.5632||||||p-value for participant's global assessment on investigational product at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Chi-squared|||||||0.5632
71095345|NCT05638737|141698915|SUPERIORITY|One-sided test where a negative change in relative to baseline is favourable|%-change in relative to base vs placebo|7.5||||0.893|TWO_SIDED|95.0|-4.1|20.5|||Mixed Models Analysis|Participant as random effect; treatment, visit and trt:vis interaction as fixed effects; baseline ALT as covariate. Model uses log-scaled variables.||||20.5|-4.1|0.893
71095346|NCT05638737|141698916|SUPERIORITY|One-sided test where a negative change in relative to baseline is favourable|%-change in relative to base vs placebo|-0.9||||0.396|TWO_SIDED|95.0|-7.5|6.1|||Mixed Models Analysis|Participant as random effect; treatment, visit and trt:vis interaction as fixed effects; baseline Pro-C3 as covariate. Model uses log-scaled variables||||6.1|-7.5|0.396
71095347|NCT04633447|141698918|SUPERIORITY||Difference in Percentage|6.6|||=|0.638|TWO_SIDED|90.0|-14.7|27.9|||Cochran-Mantel-Haenszel|||||27.9|-14.7|=0.638
71095348|NCT04333498|141698936|OTHER||Mean Difference (Net)|-221.03||||0.014|TWO_SIDED|95.0|-396.33|-45.73|||t-test, 2 sided|||||-45.73|-396.33|.014
71095349|NCT04333498|141698937|OTHER||Mean Difference (Net)|1103.96||||0.122|TWO_SIDED|95.0|-296.532|2502.722|||t-test, 2 sided|||||2502.722|-296.532|0.122
71095350|NCT04333498|141698938|OTHER||Mean Difference (Net)|-2.61||||0.218|TWO_SIDED|95.0|-8.614|3.391|||t-test, 2 sided|||Adherence percentage||3.391|-8.614|.218
71095351|NCT04333498|141698938|OTHER|Linear regression with generalized estimating equations (GEE)|Slope|0.046||||0.272|TWO_SIDED|95.0|-0.036|0.128|||Regression, Linear|||||0.128|-0.036|0.272
71095352|NCT01565694|141698939|OTHER|P-Value was from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||<0.001
71095353|NCT01565694|141698939|OTHER|P-Value was from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||<0.001
71095354|NCT01565694|141698940|OTHER|P-Value was obtained from a 2-sided one sample t-test, testing the null hypothesis that Change from Baseline=0.|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71095355|NCT01565694|141698941|OTHER|P-Value was from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.029|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||0.029
71095356|NCT01565694|141698941|OTHER|P-Value was from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.026|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||0.026
71095357|NCT01565694|141698942|OTHER|From a Wilcoxon Signed Rank testing the null hypothesis is that the Median at Week 24 is equal to Baseline Median.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Analysis of change from baseline to Week 24.||||<0.001
71095358|NCT01565694|141698943|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0||||||0.006|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 in bladder volume at 30 cmH20.||||0.006
71095359|NCT01565694|141698943|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF in bladder volume at 30 cmH20.||||0.001
71095360|NCT01565694|141698944|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0||||||0.001|||||||t-test, 2 sided|||Analysis of change from baseline to week 24 in bladder volume at 40 cmH20.||||0.001
71095361|NCT01565694|141698944|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0||||||0.004|||||||t-test, 2 sided|||Analysis of change from baseline to week 24 LOCF in bladder volume at 40 cmH20.||||0.004
71095362|NCT01565694|141698945|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0||||||0.003|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||0.003
70921665|NCT00999167|141333814|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0214||95.0|||||Cochran-Mantel-Haenszel|||||||0.0214
70921666|NCT00999167|141333815|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.56||||0.047||95.0|||||Regression, Cox|||||||0.047
70921667|NCT00999167|141333816|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0713|TWO_SIDED|95.0|||||ANCOVA|||Changes in the Total Index Score from Baseline and Day 56.||||0.0713
70921668|NCT00999167|141333816|SUPERIORITY_OR_OTHER_LEGACY|||||||0.252|TWO_SIDED|95.0|||||ANCOVA|||Changes in the Total Index Score from Baseline and the Final Visit.||||0.2520
70921669|NCT02554786|141333817|SUPERIORITY||Least Square mean (LS Mean)|0.132|STANDARD_ERROR_OF_MEAN|0.0223|<|0.001|TWO_SIDED|95.0|0.088|0.176|||Mixed Model for Repeated Measures (MMRM)|||||0.176|0.088|<0.001
70921670|NCT02554786|141333817|SUPERIORITY||LS Mean|0.211|STANDARD_ERROR_OF_MEAN|0.0224|<|0.001|TWO_SIDED|95.0|0.167|0.255|||MMRM|||||0.255|0.167|<0.001
70921671|NCT02554786|141333818|SUPERIORITY||LS Mean|-0.172|STANDARD_ERROR_OF_MEAN|0.0415|<|0.001|TWO_SIDED|95.0|-0.254|-0.091|||MMRM|||Week 4||-0.091|-0.254|<0.001
70921672|NCT02554786|141333818|SUPERIORITY||LS Mean|-0.196|STANDARD_ERROR_OF_MEAN|0.0416|<|0.001|TWO_SIDED|95.0|-0.278|-0.115|||MMRM|||Week 4||-0.115|-0.278|<0.001
70921673|NCT02554786|141333818|SUPERIORITY||LS Mean|-0.055|STANDARD_ERROR_OF_MEAN|0.0414||0.186|TWO_SIDED|95.0|-0.136|0.026|||MMRM|||Week 4||0.026|-0.136|0.186
70921674|NCT02554786|141333818|SUPERIORITY||LS Mean|-0.184|STANDARD_ERROR_OF_MEAN|0.0294|<|0.001|TWO_SIDED|95.0|-0.242|-0.127|||MMRM|||Week 4: The comparison of QMF149 vs. MF was based on combined effects of QMF149 150/160 \& 150/320 μg and MF 400 \& 800 μg derived by weighting treatment groups equally.||-0.127|-0.242|<0.001
70921675|NCT02554786|141333818|SUPERIORITY||LS Mean|-0.129|STANDARD_ERROR_OF_MEAN|0.0431||0.003|TWO_SIDED|95.0|-0.214|-0.044|||MMRM|||Week 12||-0.044|-0.214|0.003
70921676|NCT02554786|141333818|SUPERIORITY||LS Mean|-0.248|STANDARD_ERROR_OF_MEAN|0.0435|<|0.001|TWO_SIDED|95.0|-0.333|-0.162|||MMRM|||Week 12||-0.162|-0.333|<0.001
70921677|NCT02554786|141333818|SUPERIORITY||LS Mean|-0.052|STANDARD_ERROR_OF_MEAN|0.0431||0.232|TWO_SIDED|95.0|-0.136|0.033|||MMRM|||Week 12||0.033|-0.136|0.232
70921678|NCT02554786|141333818|SUPERIORITY||LS Mean|-0.188|STANDARD_ERROR_OF_MEAN|0.0307|<|0.001|TWO_SIDED|95.0|-0.248|-0.128|||MMRM|||Week 12: The comparison of QMF149 vs. MF was based on combined effects of QMF149 150/160 \& 150/320 μg and MF 400 \& 800 μg derived by weighting treatment groups equally.||-0.128|-0.248|<0.001
70921679|NCT02554786|141333818|SUPERIORITY||LS Mean|-0.171|STANDARD_ERROR_OF_MEAN|0.0437|<|0.001|TWO_SIDED|95.0|-0.257|-0.086|||MMRM|||Week 26||-0.086|-0.257|<0.001
70921680|NCT02554786|141333818|SUPERIORITY||LS Mean|-0.248|STANDARD_ERROR_OF_MEAN|0.0439|<|0.001|TWO_SIDED|95.0|-0.334|-0.162|||MMRM|||Week 26||-0.162|-0.334|<0.001
70974462|NCT02475655|141455741|SUPERIORITY||Mean Difference (Net)|37754.0|||<|0.001|TWO_SIDED|90.0|19609.0|55898.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in platelet values from Entry to Week 1/2.||55898|19609|<0.001
70974463|NCT02475655|141455741|SUPERIORITY||Mean Difference (Net)|27832.0||||0.012|TWO_SIDED|90.0|9849.0|45815.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in platelet values from Entry to Week 4/5.||45815|9849|0.012
70974464|NCT02475655|141455741|SUPERIORITY||Mean Difference (Net)|5376.0||||0.52|TWO_SIDED|90.0|-8592.0|19344.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in platelet values from Entry to Week 10/12.||19344|-8592|0.52
70974465|NCT02475655|141455743|SUPERIORITY||Mean Difference (Net)|4.96||||0.05|TWO_SIDED|90.0|0.78|9.14||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Aspartate Aminotransferase (AST) (SGOT) values from Entry to Week 1/2.||9.14|0.78|0.05
70921681|NCT02554786|141333818|SUPERIORITY||LS Mean|-0.054|STANDARD_ERROR_OF_MEAN|0.0437||0.214|TWO_SIDED|95.0|-0.14|0.031|||MMRM|||Week 26||0.031|-0.140|0.214
71033474|NCT03733444|141577007|SUPERIORITY||LS Mean difference|-0.4||||0.8064|TWO_SIDED|95.0|-3.4|2.7||LS mean difference (95% CI) per treatment group with treatment, time (categorical), treatment-by-time interaction, stratum and baseline SGRQ total score as fixed effects and participant as random effect.|Mixed Models Analysis|||||2.7|-3.4|0.8064
71033475|NCT03733444|141577008|SUPERIORITY||LS Mean difference|2.9|STANDARD_ERROR_OF_MEAN|23.39|||TWO_SIDED|95.0|-41.1|46.8|||||The treatment effect was determined by using estimated slopes for each study group on the basis of the time-by-treatment interaction term from the mixed model.|||46.8|-41.1|
70921682|NCT02554786|141333818|SUPERIORITY||LS Mean|-0.209|STANDARD_ERROR_OF_MEAN|0.031|<|0.001|TWO_SIDED|95.0|-0.27|-0.149|||MMRM|||Week 26: The comparison of QMF149 vs. MF was based on combined effects of QMF149 150/160 \& 150/320 μg and MF 400 \& 800 μg derived by weighting treatment groups equally.||-0.149|-0.270|<0.001
70921683|NCT02554786|141333818|SUPERIORITY||LS Mean|-0.141|STANDARD_ERROR_OF_MEAN|0.0449||0.002|TWO_SIDED|95.0|-0.229|-0.053|||MMRM|||Week 52||-0.053|-0.229|0.002
70921684|NCT02554786|141333818|SUPERIORITY||LS Mean|-0.266|STANDARD_ERROR_OF_MEAN|0.045|<|0.001|TWO_SIDED|95.0|-0.354|-0.177|||MMRM|||Week 52||-0.177|-0.354|<0.001
70921685|NCT02554786|141333818|SUPERIORITY||LS Mean|0.01|STANDARD_ERROR_OF_MEAN|0.0447||0.824|TWO_SIDED|95.0|-0.078|0.098|||MMRM|||Week 52||0.098|-0.078|0.824
70921686|NCT02554786|141333818|SUPERIORITY||LS Mean|-0.203|STANDARD_ERROR_OF_MEAN|0.0318|<|0.001|TWO_SIDED|95.0|-0.266|-0.141|||MMRM|||Week 52: The comparison of QMF149 vs. MF was based on combined effects of QMF149 150/160 \& 150/320 μg and MF 400 \& 800 μg derived by weighting treatment groups equally.||-0.141|-0.266|<0.001
70921687|NCT02554786|141333819|SUPERIORITY||LS Mean|0.136|STANDARD_ERROR_OF_MEAN|0.0235|<|0.001|TWO_SIDED|95.0|0.09|0.183|||MMRM|||||0.183|0.090|<0.001
70921688|NCT02554786|141333819|SUPERIORITY||LS Mean|0.209|STANDARD_ERROR_OF_MEAN|0.0235|<|0.001|TWO_SIDED|95.0|0.163|0.255|||MMRM|||||0.255|0.163|<0.001
70921689|NCT02554786|141333819|SUPERIORITY||LS Mean|0.048|STANDARD_ERROR_OF_MEAN|0.0234||0.04|TWO_SIDED|95.0|0.002|0.094|||MMRM|||||0.094|0.002|0.04
70921690|NCT02554786|141333820|SUPERIORITY||LS Mean|0.132|STANDARD_ERROR_OF_MEAN|0.0193|<|0.001|TWO_SIDED|95.0|0.094|0.17|||MMRM|||Day 30||0.170|0.094|<0.001
70921691|NCT02554786|141333820|SUPERIORITY||LS Mean|0.196|STANDARD_ERROR_OF_MEAN|0.0194|<|0.001|TWO_SIDED|95.0|0.158|0.234|||MMRM|||Day 30||0.234|0.158|<0.001
70921692|NCT02554786|141333820|SUPERIORITY||LS Mean|0.035|STANDARD_ERROR_OF_MEAN|0.0192||0.064|TWO_SIDED|95.0|-0.002|0.073|||MMRM|||Day 30||0.073|-0.002|0.064
71095363|NCT01565694|141698945|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0||||||0.028|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||0.028
71095364|NCT01565694|141698946|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.068|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||0.068
71095365|NCT01565694|141698946|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.075|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||0.075
71095366|NCT01565694|141698947|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||<0.001
71033476|NCT03733444|141577008|SUPERIORITY||LS Mean difference|8.0|STANDARD_ERROR_OF_MEAN|22.16|||TWO_SIDED|95.0|-35.5|51.5|||||The treatment effect was determined by using estimated slopes for each study group on the basis of the time-by-treatment interaction term from the mixed model.|||51.5|-35.5|
71033477|NCT03733444|141577009|SUPERIORITY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.9|1.94|||||Odds ratio and 95% confidence interval originated from a logistic regression.|||1.94|0.90|
71033478|NCT03733444|141577009|SUPERIORITY||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.72|1.56|||||Odds ratio and 95% confidence interval originated from a logistic regression.|||1.56|0.72|
70921693|NCT02554786|141333820|SUPERIORITY||LS Mean|0.122|STANDARD_ERROR_OF_MEAN|0.0201|<|0.001|TWO_SIDED|95.0|0.083|0.162|||MMRM|||Day 86||0.162|0.083|<0.001
71095367|NCT01565694|141698947|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||<0.001
70921694|NCT02554786|141333820|SUPERIORITY||LS Mean|0.184|STANDARD_ERROR_OF_MEAN|0.0202|<|0.001|TWO_SIDED|95.0|0.144|0.224|||MMRM|||Day 86||0.224|0.144|<0.001
71033479|NCT03733444|141577010|SUPERIORITY||LS Mean difference|0.9|||||TWO_SIDED|95.0|-12.4|14.1|||||The treatment effect was determined by using estimated least square mean difference between each active treatment group and placebo from the mixed model.|||14.1|-12.4|
71033480|NCT03733444|141577010|SUPERIORITY||LS Mean difference|3.6|||||TWO_SIDED|95.0|-10.4|17.6|||||The treatment effect was determined by using estimated least square mean difference between each active treatment group and placebo from the mixed model.|||17.6|-10.4|
71033481|NCT03733444|141577011|SUPERIORITY||Hazard Ratio (HR)|1.54|||||TWO_SIDED|95.0|1.01|2.35|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause hospitalization.|||2.35|1.01|
71033482|NCT03733444|141577011|SUPERIORITY||Hazard Ratio (HR)|1.4|||||TWO_SIDED|95.0|0.91|2.16|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to all cause hospitalization.|||2.16|0.91|
71095368|NCT01565694|141698948|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||<0.001
71095369|NCT01565694|141698948|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||<0.001
71095370|NCT01565694|141698949|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||<0.001
71095371|NCT01565694|141698949|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||<0.001
71095372|NCT01565694|141698950|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||<0.001
71095373|NCT01565694|141698950|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||<0.001
71095374|NCT01565694|141698951|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.01|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||0.010
71095375|NCT01565694|141698951|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.004|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||0.004
71095376|NCT01565694|141698952|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||<0.001
71095377|NCT01565694|141698952|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||<0.001
71095378|NCT01565694|141698953|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.568|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||0.568
71095379|NCT01565694|141698953|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.573|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||0.573
71095380|NCT06059066|141698963|OTHER|||||||0.57||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Willingness to repeat procedure immediately after received intradetrusor BTX-A injections||||0.57
71095381|NCT06059066|141698963|OTHER|||||||0.83||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Willingness to repeat procedure asses 6-weeks after intradetrusor BTX-A injections||||0.83
71095382|NCT06059066|141698964|OTHER|||||||0.59||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in total ICIQ-SF score assessed before and 6-weeks after treatment||||0.59
71095383|NCT06059066|141698964|OTHER|||||||0.29||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in ICIQ QoL score assessed before and 6-weeks after treatment||||0.29
71095384|NCT06059066|141698965|OTHER|||||||0.57||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in total NBSS-SF score assessed before and 6-weeks after treatment||||0.57
71095385|NCT06059066|141698965|OTHER|||||||0.42||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in NBSS-SF QoL score assessed before and 6-weeks after treatment||||0.42
70974466|NCT02475655|141455743|SUPERIORITY||Mean Difference (Net)|8.15|||<|0.001|TWO_SIDED|90.0|4.47|11.8||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Aspartate Aminotransferase (AST) (SGOT) values from Entry to Week 4/5.||11.8|4.47|<0.001
70974467|NCT02475655|141455743|SUPERIORITY||Mean Difference (Net)|3.95||||0.025|TWO_SIDED|90.0|1.08|6.81||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Aspartate Aminotransferase (AST) (SGOT) values from Entry to Week 10/12.||6.81|1.08|0.025
70974468|NCT02475655|141455745|SUPERIORITY||Mean Difference (Net)|4.9||||0.02|TWO_SIDED|90.0|1.46|8.33||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Alanine Aminotransferase (ALT) (SGPT) values from Entry to Week 1/2.||8.33|1.46|0.020
70974469|NCT02475655|141455745|SUPERIORITY||Mean Difference (Net)|11.0||||0.004|TWO_SIDED|90.0|4.84|17.1||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Alanine Aminotransferase (ALT) (SGPT) values from Entry to Week 4/5.||17.1|4.84|0.004
70974470|NCT02475655|141455745|SUPERIORITY||Mean Difference (Net)|4.64||||0.043|TWO_SIDED|90.0|0.88|8.39||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Alanine Aminotransferase (ALT) (SGPT) values from Entry to Week 10/12.||8.39|0.88|0.043
70974471|NCT02475655|141455746|SUPERIORITY||Mean Difference (Net)|1.1||||0.56|TWO_SIDED|90.0|0.84|1.44||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Plasma Interleukin 6 (IL-6) from baseline to Week 10/12.||1.44|0.84|0.56
70974472|NCT02475655|141455746|SUPERIORITY||Mean Difference (Net)|1.37||||0.026|TWO_SIDED|90.0|1.09|1.73||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Plasma Interleukin 6 (IL-6) from Week 4/5 to Week 10/12.||1.73|1.09|0.026
70974473|NCT02475655|141455747|SUPERIORITY||Mean Difference (Net)|0.89||||0.07|TWO_SIDED|90.0|0.8|0.99||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in soluble CD14 (sCD14) from baseline to Week 4/5.||0.99|0.80|0.07
70974474|NCT02475655|141455747|SUPERIORITY||Mean Difference (Net)|0.95||||0.59|TWO_SIDED|90.0|0.8|1.12||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in soluble CD14 (sCD14) from baseline to Week 12.||1.12|0.80|0.59
70974475|NCT02475655|141455747|SUPERIORITY||Mean Difference (Net)|1.06||||0.56|TWO_SIDED|90.0|0.9|1.24||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in soluble CD14 (sCD14) from Week 4/5 to Week 12.||1.24|0.90|0.56
70974476|NCT02475655|141455748|SUPERIORITY||Mean Difference (Net)|142.1||||0.007|TWO_SIDED|90.0|57.6|227.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in CD4+ T cell counts from Baseline to Week 2.||227|57.6|0.007
70974477|NCT02475655|141455748|SUPERIORITY||Mean Difference (Net)|74.3||||0.14|TWO_SIDED|90.0|-8.23|156.7||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in CD4+ T cell counts from Baseline to Week 5.||156.7|-8.23|0.14
70974478|NCT02475655|141455748|SUPERIORITY||Mean Difference (Net)|-38.9||||0.54|TWO_SIDED|90.0|-143.0|65.5||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in CD4+ T cell counts from Baseline to Week 12.||65.5|-143|0.54
70974479|NCT02475655|141455748|SUPERIORITY||Mean Difference (Net)|-112.0||||0.12|TWO_SIDED|90.0|-231.0|5.9||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|There is no difference between the two arms in the change in CD4+ T cell counts from Week 5 to Week 12.||5.90|-231|0.12
70974480|NCT02475655|141455750|SUPERIORITY||Risk Ratio (RR)|0.98||||0.94|TWO_SIDED|90.0|0.65|1.49||Not adjusted for multiple comparisons. Two-sided 10% alpha.|GEE|A GEE model for binary data was used to compare changes in iSCA because a substantial proportion of data was below the assay limit.|Risk ratio is Ruxolitinib risk divided by No Study Treatment risk.|Null hypothesis: There is no difference between the two arms in the change in HIV-1 RNA by iSCA from Entry to Week 5.||1.49|0.65|0.94
71095386|NCT06059066|141698965|OTHER|||||||0.24||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in NBSS-SF incontinence domain score assessed before and 6-weeks after treatment||||0.24
71095387|NCT06059066|141698965|OTHER|||||||0.93||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in NBSS-SF storage and voiding domain score assessed before and 6-weeks after treatment||||0.93
71095388|NCT06059066|141698965|OTHER|||||||0.64||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in NBSS-SF consequences domain score assessed before and 6-weeks after treatment||||0.64
70921695|NCT02554786|141333820|SUPERIORITY||LS Mean|0.037|STANDARD_ERROR_OF_MEAN|0.02||0.063|TWO_SIDED|95.0|-0.002|0.076|||MMRM|||Day 86||0.076|-0.002|0.063
70921696|NCT02554786|141333821|SUPERIORITY||LS Mean|0.142|STANDARD_ERROR_OF_MEAN|0.0116|<|0.001|TWO_SIDED|95.0|0.119|0.164|||MMRM|||Day 1: 5 minutes||0.164|0.119|<0.001
70921697|NCT02554786|141333821|SUPERIORITY||LS Mean|0.152|STANDARD_ERROR_OF_MEAN|0.0116|<|0.001|TWO_SIDED|95.0|0.129|0.175|||MMRM|||Day 1: 5 minutes||0.175|0.129|<0.001
70921698|NCT02554786|141333821|SUPERIORITY||LS Mean|0.055|STANDARD_ERROR_OF_MEAN|0.0116|<|0.001|TWO_SIDED|95.0|0.032|0.078|||MMRM|||Day 1: 5 minutes||0.078|0.032|<0.001
70921699|NCT02554786|141333821|SUPERIORITY||LS Mean|0.162|STANDARD_ERROR_OF_MEAN|0.0122|<|0.001|TWO_SIDED|95.0|0.138|0.186|||MMRM|||Day 1: 15 minutes||0.186|0.138|<0.001
70921700|NCT02554786|141333821|SUPERIORITY||LS mean|0.174|STANDARD_ERROR_OF_MEAN|0.0123|<|0.001|TWO_SIDED|95.0|0.15|0.198|||MMRM|||Day 1: 15 minutes||0.198|0.150|<.001
70921701|NCT02554786|141333821|SUPERIORITY||LS Mean|0.044|STANDARD_ERROR_OF_MEAN|0.0122|<|0.001|TWO_SIDED|95.0|0.02|0.068|||MMRM|||Day1: 15 minutes||0.068|0.02|<0.001
70974481|NCT02475655|141455750|SUPERIORITY||Risk Ratio (RR)|0.74||||0.46|TWO_SIDED|90.0|0.37|1.46||Not adjusted for multiple comparisons. Two-sided 10% alpha.|GEE|A GEE model for binary data was used to compare changes in iSCA because a substantial proportion of data was below the assay limit.|Risk ratio is Ruxolitinib risk divided by No Study Treatment risk.|Null hypothesis: There is no difference between the two arms in the change in HIV-1 RNA by iSCA from Entry to Week 12.||1.46|0.37|0.46
71095389|NCT06059066|141698966|OTHER|||||||0.21||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||||||0.21
70974482|NCT02475655|141455750|SUPERIORITY||Risk Ratio (RR)|0.83||||0.59|TWO_SIDED|90.0|0.46|1.48||Not adjusted for multiple comparisons. Two-sided 10% alpha.|GEE|A GEE model for binary data was used to compare changes in iSCA because a substantial proportion of data was below the assay limit.|Risk ratio is Ruxolitinib risk divided by No Study Treatment risk.|Null hypothesis: There is no difference between the two arms in the change in HIV-1 RNA by iSCA from Week 5 to Week 12.||1.48|0.46|0.59
70974483|NCT02475655|141455751|SUPERIORITY||Mean Difference (Net)|0.88||||0.11|TWO_SIDED|90.0|0.76|1.01||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Tumor Necrosis Factor alpha (TNF alpha) from entry to Week 5.||1.01|0.76|0.11
70974484|NCT02475655|141455751|SUPERIORITY||Mean Difference (Net)|0.92||||0.71|TWO_SIDED|90.0|0.64|1.33||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Tumor Necrosis Factor alpha (TNF alpha) from entry to Week 12.||1.33|0.64|0.71
70974485|NCT02475655|141455752|SUPERIORITY||Mean Difference (Net)|1.27||||0.3|TWO_SIDED|90.0|0.87|1.86||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 1 beta (IL-1 beta) from entry to Week 5.||1.86|0.87|0.30
70974486|NCT02475655|141455752|SUPERIORITY||Mean Difference (Net)|1.59||||0.46|TWO_SIDED|90.0|0.56|4.49||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 1 beta (IL-1 beta) from entry to Week 12.||4.49|0.56|0.46
70974487|NCT02475655|141455753|SUPERIORITY||Mean Difference (Net)|1.29||||0.24|TWO_SIDED|90.0|0.9|1.84||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 7 (IL-7) from entry to Week 5.||1.84|0.90|0.24
70974488|NCT02475655|141455753|SUPERIORITY||Mean Difference (Net)|1.19||||0.46|TWO_SIDED|90.0|0.81|1.74||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 7 (IL-7) from entry to Week 12.||1.74|0.81|0.46
70974489|NCT02475655|141455758|SUPERIORITY||Mean Difference (Net)|1.15||||0.56|TWO_SIDED|90.0|0.77|1.72||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.||Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 10 (IL-10) from entry to Week 5.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|1.72|0.77|0.56
70974490|NCT02475655|141455758|SUPERIORITY||Mean Difference (Net)|0.97||||0.95|TWO_SIDED|90.0|0.47|2.01||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 10 (IL-10) from entry to Week 12.||2.01|0.47|0.95
70974491|NCT02475655|141455759|SUPERIORITY||Mean Difference (Net)|1.34||||0.002|TWO_SIDED|90.0|1.15|1.56||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in TInterleukin 15 (IL-15) from entry to Week 5.||1.56|1.15|0.002
70974492|NCT02475655|141455759|SUPERIORITY||Mean Difference (Net)|1.07||||0.6|TWO_SIDED|90.0|0.86|1.34||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in TInterleukin 15 (IL-15) from entry to Week 12.||1.34|0.86|0.60
71033483|NCT03733444|141577014|SUPERIORITY||Hazard Ratio (HR)|2.92|||||TWO_SIDED|95.0|1.04|8.14|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first acute IPF exacerbation.|||8.14|1.04|
71033484|NCT03733444|141577014|SUPERIORITY||Hazard Ratio (HR)|1.68|||||TWO_SIDED|95.0|0.55|5.13|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first acute IPF exacerbation.|||5.13|0.55|
70974493|NCT02475655|141455760|SUPERIORITY||Mean Difference (Net)|0.94||||0.4|TWO_SIDED|90.0|0.82|1.07||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 18 (IL-18) from entry to Week 5.||1.07|0.82|0.40
70974494|NCT02475655|141455760|SUPERIORITY||Mean Difference (Net)|1.03||||0.82|TWO_SIDED|90.0|0.83|1.27||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 18 (IL-18) from entry to Week 12.||1.27|0.83|0.82
70974495|NCT02475655|141455761|SUPERIORITY||Mean Difference (Net)|1.5||||0.028|TWO_SIDED|90.0|1.11|2.02||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 1 (TGF beta-1) from entry to Week 5.||2.02|1.11|0.028
70974496|NCT02475655|141455761|SUPERIORITY||Mean Difference (Net)|2.04||||0.21|TWO_SIDED|90.0|0.79|5.25||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 1 (TGF beta-1) from entry to Week 12.||5.25|0.79|0.21
70974497|NCT02475655|141455762|SUPERIORITY||Mean Difference (Net)|1.39||||0.031|TWO_SIDED|90.0|1.08|1.79||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 2 (TGF beta-2) from entry to Week 5.||1.79|1.08|0.031
70974498|NCT02475655|141455762|SUPERIORITY||Mean Difference (Net)|0.96||||0.93|TWO_SIDED|90.0|0.46|2.02||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 2 (TGF beta-2) from entry to Week 12.||2.02|0.46|0.93
70974499|NCT02475655|141455763|SUPERIORITY||Mean Difference (Net)|1.57||||0.43|TWO_SIDED|90.0|0.61|4.05||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 3 (TGF beta-3) from entry to Week 5.||4.05|0.61|0.43
70974500|NCT02475655|141455763|SUPERIORITY||Mean Difference (Net)|0.68||||0.41|TWO_SIDED|90.0|0.3|1.5||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 3 (TGF beta-3) from entry to Week 12.||1.50|0.30|0.41
71033485|NCT03733444|141577015|SUPERIORITY||Hazard Ratio (HR)|2.27|||||TWO_SIDED|95.0|1.06|4.82|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality or hospitalization for non-elective lung transplant.|||4.82|1.06|
71033486|NCT03733444|141577015|SUPERIORITY||Hazard Ratio (HR)|1.87|||||TWO_SIDED|95.0|0.86|4.06|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality or hospitalization for non-elective lung transplant.|||4.06|0.86|
71033487|NCT03733444|141577016|SUPERIORITY||Hazard Ratio (HR)|2.27|||||TWO_SIDED|95.0|1.06|4.82|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality, hospitalization for non-elective lung transplant or hospitalization for qualifying for lung transplant.|||4.82|1.06|
71095390|NCT06059066|141698967|OTHER||||||<|2e-05||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Change in post-procedural pain as compared to baseline||||<0.00002
71095391|NCT01022580|141698974|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89|TWO_SIDED||||||unadj GEE|||||||0.89
70974501|NCT02475655|141455764|SUPERIORITY||Mean Difference (Net)|-0.34||||0.038|TWO_SIDED|90.0|-0.61|-0.07||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD4+ T-cells from Entry to Week 5.||-0.07|-0.61|0.038
70974502|NCT02475655|141455764|SUPERIORITY||Mean Difference (Net)|0.27||||0.07|TWO_SIDED|90.0|0.03|0.51||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD4+ T-cells from Entry to Week 12.||0.51|0.03|0.07
70974503|NCT02475655|141455765|SUPERIORITY||Mean Difference (Net)|-0.88||||0.05|TWO_SIDED|90.0|-1.62|-0.13||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD8+ T-cells from Entry to Week 5.||-0.13|-1.62|0.05
70974504|NCT02475655|141455765|SUPERIORITY||Mean Difference (Net)|0.86||||0.16|TWO_SIDED|90.0|-0.16|1.88||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD8+ T-cells from Entry to Week 12.||1.88|-0.16|0.16
70974505|NCT02475655|141455766|SUPERIORITY||Mean Difference (Net)|-1.71|||<|0.001|TWO_SIDED|90.0|-2.46|-0.97||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD25hi+ among CD4+ T-cells from Entry to Week 5.||-0.97|-2.46|<0.001
71033488|NCT03733444|141577016|SUPERIORITY||Hazard Ratio (HR)|1.87|||||TWO_SIDED|95.0|0.86|4.06|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality, hospitalization for non-elective lung transplant or hospitalization for qualifying for lung transplant.|||4.06|0.86|
71033489|NCT03733444|141577017|SUPERIORITY||Hazard Ratio (HR)|1.99|||||TWO_SIDED|95.0|1.2|3.31|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all-cause mortality or hospitalization that meets \>=10% absolute decline in %FVC or respiratory-related hospitalization.|||3.31|1.20|
71033490|NCT03733444|141577017|SUPERIORITY||Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|0.88|2.54|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all-cause mortality or hospitalization that meets \>=10% absolute decline in %FVC or respiratory-related hospitalization.|||2.54|0.88|
71033491|NCT03733444|141577018|SUPERIORITY||Hazard Ratio (HR)|1.99|||||TWO_SIDED|95.0|1.2|3.31|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all-cause mortality or respiratory-related hospitalizations.|||3.31|1.20|
70974506|NCT02475655|141455766|SUPERIORITY||Mean Difference (Net)|0.16||||0.68|TWO_SIDED|90.0|-0.5|0.82||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD25hi+ among CD4+ T-cells from Entry to Week 12.||0.82|-0.50|0.68
71033492|NCT03733444|141577018|SUPERIORITY||Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|0.88|2.54|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all-cause mortality or respiratory-related hospitalizations.|||2.54|0.88|
71045607|NCT02697773|141599469|SUPERIORITY|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.09||0.0109|TWO_SIDED|95.0|-0.39|-0.05||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.39|0.0109
71095392|NCT01022580|141698975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33|TWO_SIDED||||||unadj GEE|||||||0.33
71095393|NCT00541229|141698979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.8||||0.004||95.0|-53.1|-10.5|||ANOVA|Model term: treatment||For this comparison, the mean in the placebo group was subtracted from the mean in the sitagliptin 200 mg group.||-10.5|-53.1|0.004
70974507|NCT02475655|141455767|SUPERIORITY||Mean Difference (Net)|-0.01||||0.98|TWO_SIDED|90.0|-0.7|0.69||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD25+ among CD8+ T-cells from Entry to Week 5.||0.69|-0.70|0.98
71095394|NCT00541229|141698979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.9|||<|0.001||95.0|-63.6|-20.2|||ANOVA|Model term: treatment||For this comparison, the mean in the placebo group was subtracted from the mean in the sitagliptin 100 mg group.||-20.2|-63.6|<0.001
71095395|NCT00541229|141698979|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis stated that the lower bound of 80% one-sided confidence interval for the comparison in 24-hour WMG reduction between sitagliptin 200 mg and sitagliptin 100 mg is above -5 mg/dL.|Mean Difference (Final Values)|10.1||||||80.0|0.61|9999999.0|||||This is a 1-sided 80% confidence interval and the upper bound 9999999 was used here to indicate positive infinity.|This was pre-defined as a non-superiority test, i.e., to show that sitagliptin 200 mg is not superior to sitagliptin 100 mg. For this comparison, the mean in the sitagliptin 100 mg group was subtracted from the mean in the sitagliptin 200 mg group.||9999999|0.61|
71033493|NCT01940341|141577081|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sample sizes of 130 and 260 participants in the TDF group and TAF groups, respectively were planned to give 90% power to rule out the noninferiority margin of 10% at a 1-sided significance level of 0.025. This sample size was based on the assumption that the expected difference (TAF-TDF) in proportion of participants with HBV DNA\<29 IU/mL was 0 and the proportion of participants with HBV DNA\<29 IU/mL in the TDF group was 91%. All missing data were treated as not achieving the primary endpoint.|Difference in proportions|1.8|||||TWO_SIDED|95.0|-3.6|7.2|||||Difference in the proportion between treatment groups and its 95% CI were calculated based on the Mantel-Haenszel (MH) proportions adjusted by baseline HBV DNA categories and oral antiviral treatment status strata.|The null hypothesis was that the TAF group is at least 10% worse than the TDF group with respect to the proportion of participants with HBV DNA \< 29 IU/mL at Week 48. The alternative hypothesis was that the TAF group is less than 10% worse than the TDF group with respect to the proportion of participants with HBV DNA \< 29 IU/mL at Week 48. Noninferiority was assessed using a 95% confidence interval (CI) approach, with a noninferiority margin of 10%.||7.2|-3.6|
71033494|NCT00841698|141577097|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|97.34||||||90.0|91.67|103.35|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.35|91.67|
71033495|NCT00841698|141577098|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|94.46||||||90.0|90.22|98.89|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||98.89|90.22|
71033496|NCT00841698|141577099|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|94.83||||||90.0|89.96|99.96|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.96|89.96|
71033497|NCT00185458|141577100|SUPERIORITY_OR_OTHER|||||||0.128||95.0|||||Friedman's two-way ANOVA|||Time effect tested with Friedman's two-way analysis of variance (ANOVA). The null-hypothesis is that the means are equal at the reference period tested.||||0.128
71033498|NCT00185458|141577101|SUPERIORITY_OR_OTHER|||||||0.296||95.0|||||Friedman's two-way ANOVA|||Time effect tested with Friedman's two-way analysis of variance (ANOVA). The null-hypothesis is that the means are equal at the reference period tested.||||0.296
71033499|NCT00185458|141577103|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
71033500|NCT00185458|141577105|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||0.027
71033501|NCT00185458|141577106|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
71095396|NCT01807520|141698980|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.7|STANDARD_ERROR_OF_MEAN|6.26|<|0.0001|TWO_SIDED|95.0|-39.1|-14.3|||Mixed model reapeated measures|||||-14.3|-39.1|<0.0001
70921702|NCT02554786|141333821|SUPERIORITY||LS Mean|0.175|STANDARD_ERROR_OF_MEAN|0.0132|<|0.001|TWO_SIDED|95.0|0.149|0.201|||MMRM|||Day 1: 30 minutes||0.201|0.149|<0.001
71033502|NCT00185458|141577107|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
71033503|NCT00185458|141577108|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
71033504|NCT00185458|141577109|SUPERIORITY_OR_OTHER|||||||0.054||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||0.054
71033505|NCT00185458|141577110|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
71033506|NCT00185458|141577111|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
71095397|NCT01807520|141698980|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.4|STANDARD_ERROR_OF_MEAN|5.47|<|0.0001|TWO_SIDED|95.0|-45.2|-23.5|||Mixed model repeated measures|||||-23.5|-45.2|<0.0001
71095398|NCT01500096|141698984|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.15
71095399|NCT01500096|141698984|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms||||0.73
71095400|NCT01500096|141698985|SUPERIORITY|||||||0.1329|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.1329
71095401|NCT01500096|141698985|SUPERIORITY|||||||0.1191|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.1191
71095402|NCT01500096|141698986|SUPERIORITY|||||||0.7454|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.7454
71095403|NCT01500096|141698986|SUPERIORITY|||||||0.7391|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.7391
71095404|NCT01500096|141698987|SUPERIORITY|||||||0.6818|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.6818
70921703|NCT02554786|141333821|SUPERIORITY||LS Mean|0.185|STANDARD_ERROR_OF_MEAN|0.0132|<|0.001|TWO_SIDED|95.0|0.159|0.211|||MMRM|||Day 1: 30 minutes||0.211|0.159|<0.001
70921704|NCT02554786|141333821|SUPERIORITY||LS Mean|0.027|STANDARD_ERROR_OF_MEAN|0.0132||0.038|TWO_SIDED|95.0|0.001|0.053|||MMRM|||Day 1: 30 minutes||0.053|0.001|0.038
70921705|NCT02554786|141333821|SUPERIORITY||LS Mean|0.178|STANDARD_ERROR_OF_MEAN|0.0139|<|0.001|TWO_SIDED|95.0|0.15|0.205|||MMRM|||Day 1: 1 hour||0.205|0.150|<0.001
70921706|NCT02554786|141333821|SUPERIORITY||LS Mean|0.205|STANDARD_ERROR_OF_MEAN|0.0139|<|0.001|TWO_SIDED|95.0|0.177|0.232|||MMRM|||Day 1: 1hour||0.232|0.177|<0.001
70921707|NCT02554786|141333821|SUPERIORITY||LS Mean|0.007|STANDARD_ERROR_OF_MEAN|0.0139||0.632|TWO_SIDED|95.0|-0.021|0.034|||MMRM|||Day 1: 1hour||0.034|-0.021|0.632
70921708|NCT02554786|141333821|SUPERIORITY||LS Mean|0.189|STANDARD_ERROR_OF_MEAN|0.0192|<|0.001|TWO_SIDED|95.0|0.151|0.226|||MMRM|||Day 30: 5 minutes||0.226|0.151|<0.001
70921709|NCT02554786|141333821|SUPERIORITY||LS Mean|0.232|STANDARD_ERROR_OF_MEAN|0.0194|<|0.001|TWO_SIDED|95.0|0.194|0.27|||MMRM|||Day 30: 5 minutes||0.270|0.194|<0.001
70921710|NCT02554786|141333821|SUPERIORITY||LS Mean|0.053|STANDARD_ERROR_OF_MEAN|0.0191||0.005|TWO_SIDED|95.0|0.016|0.091|||MMRM|||Day 30: 5 minutes||0.091|0.016|0.005
70921711|NCT02554786|141333821|SUPERIORITY||LS Mean|0.194|STANDARD_ERROR_OF_MEAN|0.0194|<|0.001|TWO_SIDED|95.0|0.156|0.232|||MMRM|||Day 30: 30 minutes||0.232|0.156|<0.001
70921712|NCT02554786|141333821|SUPERIORITY||LS Mean|0.253|STANDARD_ERROR_OF_MEAN|0.0196|<|0.001|TWO_SIDED|95.0|0.214|0.291|||MMRM|||Day 30: 30 minutes||0.291|0.214|<0.001
70921713|NCT02554786|141333821|SUPERIORITY||LS Mean|0.043|STANDARD_ERROR_OF_MEAN|0.0192||0.026|TWO_SIDED|95.0|0.005|0.08|||MMRM|||Day 30: 30 minutes||0.08|0.005|0.026
70921714|NCT02554786|141333821|SUPERIORITY||LS Mean|0.19|STANDARD_ERROR_OF_MEAN|0.0196|<|0.001|TWO_SIDED|95.0|0.152|0.229|||MMRM|||Day 30: 1 hour||0.229|0.152|<0.001
70921715|NCT02554786|141333821|SUPERIORITY||LS Mean|0.258|STANDARD_ERROR_OF_MEAN|0.0198|<|0.001|TWO_SIDED|95.0|0.219|0.296|||MMRM|||Day 30: 1 hour||0.296|0.219|<0.001
70921716|NCT02554786|141333821|SUPERIORITY||LS Mean|0.037|STANDARD_ERROR_OF_MEAN|0.0194||0.059|TWO_SIDED|95.0|-0.001|0.075|||MMRM|||Day 30: 1 hour||0.075|-0.001|0.059
70921717|NCT02554786|141333821|SUPERIORITY||LS Mean|0.163|STANDARD_ERROR_OF_MEAN|0.0204|<|0.001|TWO_SIDED|95.0|0.123|0.203|||MMRM|||Day 86: 5 minutes||0.203|0.123|<0.001
70921718|NCT02554786|141333821|SUPERIORITY||LS Mean|0.231|STANDARD_ERROR_OF_MEAN|0.0206|<|0.001|TWO_SIDED|95.0|0.191|0.271|||MMRM|||Day 86: 5 minutes||0.271|0.191|<0.001
70921719|NCT02554786|141333821|SUPERIORITY||LS Mean|0.055|STANDARD_ERROR_OF_MEAN|0.0203||0.007|TWO_SIDED|95.0|0.015|0.095|||MMRM|||Day 86: 5minutes||0.095|0.015|0.007
70974508|NCT02475655|141455767|SUPERIORITY||Mean Difference (Net)|-0.16||||0.79|TWO_SIDED|90.0|-1.13|0.82||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD25+ among CD8+ T-cells from Entry to Week 12.||0.82|-1.13|0.79
70974509|NCT02475655|141455768|SUPERIORITY||Mean Difference (Net)|3.49||||0.001|TWO_SIDED|90.0|1.75|5.22||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD127+ among CD4+ T-cells from Entry to Week 5.||5.22|1.75|0.001
70974510|NCT02475655|141455768|SUPERIORITY||Mean Difference (Net)|-1.3||||0.28|TWO_SIDED|90.0|-3.28|0.68||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.||Null hypothesis: There is no difference between the two arms in the change in the expression of CD127+ among CD4+ T-cells from Entry to Week 12.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|0.68|-3.28|0.28
70974511|NCT02475655|141455769|SUPERIORITY||Mean Difference (Net)|6.54|||<|0.001|TWO_SIDED|90.0|3.76|9.31||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD127+ among CD8+ T-cells from Entry to Week 5.||9.31|3.76|<0.001
70921720|NCT02554786|141333821|SUPERIORITY||LS Mean|0.18|STANDARD_ERROR_OF_MEAN|0.0203|<|0.001|TWO_SIDED|95.0|0.14|0.219|||MMRM|||Day 86: 30 minutes||0.219|0.140|<0.001
70921721|NCT02554786|141333821|SUPERIORITY||LS Mean|0.252|STANDARD_ERROR_OF_MEAN|0.0205|<|0.001|TWO_SIDED|95.0|0.211|0.292|||MMRM|||Day 86: 30 minutes||0.292|0.211|<0.001
70921722|NCT02554786|141333821|SUPERIORITY||LS Mean|0.038|STANDARD_ERROR_OF_MEAN|0.0202||0.057|TWO_SIDED|95.0|-0.001|0.078|||MMRM|||Day 86: 30 minutes||0.078|-0.001|0.057
70921723|NCT02554786|141333821|SUPERIORITY||LS Mean|0.187|STANDARD_ERROR_OF_MEAN|0.0205|<|0.001|TWO_SIDED|95.0|0.147|0.227|||MMRM|||Day 86: 1 hour||0.227|0.147|<0.001
70921724|NCT02554786|141333821|SUPERIORITY||LS Mean|0.249|STANDARD_ERROR_OF_MEAN|0.0208|<|0.001|TWO_SIDED|95.0|0.208|0.289|||MMRM|||Day 86: 1 hour||0.289|0.208|<0.001
70921725|NCT02554786|141333821|SUPERIORITY||LS Mean|0.043|STANDARD_ERROR_OF_MEAN|0.0205||0.037|TWO_SIDED|95.0|0.003|0.083|||MMRM|||Day 86: 1hour||0.083|0.003|0.037
70921726|NCT02554786|141333821|SUPERIORITY||LS Mean|0.163|STANDARD_ERROR_OF_MEAN|0.0217|<|0.001|TWO_SIDED|95.0|0.121|0.206|||MMRM|||Day 183: 5 minutes||0.206|0.121|<0.001
70921727|NCT02554786|141333821|SUPERIORITY||LS Mean|0.243|STANDARD_ERROR_OF_MEAN|0.0219|<|0.001|TWO_SIDED|95.0|0.2|0.286|||MMRM|||Day 183: 5 minutes||0.286|0.200|<0.001
70921728|NCT02554786|141333821|SUPERIORITY||LS Mean|0.044|STANDARD_ERROR_OF_MEAN|0.0216||0.041|TWO_SIDED|95.0|0.002|0.087|||MMRM|||Day 183: 5 minutes||0.087|0.002|0.041
70921729|NCT02554786|141333821|SUPERIORITY||LS Mean|0.176|STANDARD_ERROR_OF_MEAN|0.0222|<|0.001|TWO_SIDED|95.0|0.133|0.22|||MMRM|||Day 183: 30 minutes||0.220|0.133|<0.001
70974512|NCT02475655|141455769|SUPERIORITY||Mean Difference (Net)|-0.19||||0.92|TWO_SIDED|90.0|-3.56|3.18||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD127+ among CD8+ T-cells from Entry to Week 12.||3.18|-3.56|0.92
70974513|NCT02475655|141455770|SUPERIORITY||Mean Difference (Net)|-0.07||||0.82|TWO_SIDED|90.0|-0.61|0.47||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Ki67+ among CD4+ T-cells from Entry to Week 5.||0.47|-0.61|0.82
70974514|NCT02475655|141455770|SUPERIORITY||Mean Difference (Net)|0.76||||0.033|TWO_SIDED|90.0|0.18|1.34||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Ki67+ among CD4+ T-cells from Entry to Week 12.||1.34|0.18|0.033
70974515|NCT02475655|141455771|SUPERIORITY||Mean Difference (Net)|0.01||||0.98|TWO_SIDED|90.0|-0.53|0.55||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Ki67+ among CD8+ T-cells from Entry to Week 5.||0.55|-0.53|0.98
70974516|NCT02475655|141455771|SUPERIORITY||Mean Difference (Net)|0.55||||0.37|TWO_SIDED|90.0|-0.46|1.57||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Ki67+ among CD8+ T-cells from Entry to Week 12.||1.57|-0.46|0.37
70974517|NCT02475655|141455772|SUPERIORITY||Mean Difference (Net)|-3.3|||<|0.001|TWO_SIDED|90.0|-4.72|-1.87||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Bcl2+ among CD4+ T-cells from Entry to Week 5.||-1.87|-4.72|<0.001
70974518|NCT02475655|141455772|SUPERIORITY||Mean Difference (Net)|-0.73||||0.09|TWO_SIDED|90.0|-1.42|-0.03||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Bcl2+ among CD4+ T-cells from Entry to Week 12.||-0.03|-1.42|0.09
70974519|NCT02475655|141455773|SUPERIORITY||Mean Difference (Net)|-5.4|||<|0.001|TWO_SIDED|90.0|-7.29|-3.5||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Bcl2+ among CD8+ T-cells from Entry to Week 5.||-3.50|-7.29|<0.001
71095405|NCT01500096|141698987|SUPERIORITY|||||||0.0579|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.0579
71095406|NCT01500096|141698988|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.17
70974520|NCT02475655|141455773|SUPERIORITY||Mean Difference (Net)|-1.23||||0.11|TWO_SIDED|90.0|-2.51|0.05||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Bcl2+ among CD8+ T-cells from Entry to Week 12.||0.05|-2.51|0.11
70974521|NCT02475655|141455774|SUPERIORITY||Mean Difference (Net)|-1.54||||0.26|TWO_SIDED|90.0|-3.78|0.7||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of a4b7+ among CD4+ T-cells from Entry to Week 5.||0.70|-3.78|0.26
70974522|NCT02475655|141455774|SUPERIORITY||Mean Difference (Net)|-0.39||||0.74|TWO_SIDED|90.0|-2.41|1.62||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of a4b7+ among CD4+ T-cells from Entry to Week 12.||1.62|-2.41|0.74
71095407|NCT01500096|141698988|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.51
70974523|NCT02475655|141455775|SUPERIORITY||Mean Difference (Net)|0.55||||0.71|TWO_SIDED|90.0|-1.9|3.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of a4b7+ among CD8+ T-cells from Entry to Week 5.||3.00|-1.90|0.71
70974524|NCT02475655|141455775|SUPERIORITY||Mean Difference (Net)|0.31||||0.83|TWO_SIDED|90.0|-2.15|2.78||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of a4b7+ among CD8+ T-cells from Entry to Week 12.||2.78|-2.15|0.83
71095408|NCT01500096|141698989|SUPERIORITY|||||||0.7884|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.7884
71095409|NCT01500096|141698989|SUPERIORITY|||||||0.5532|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.5532
71095410|NCT01500096|141698990|SUPERIORITY|||||||0.9885|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.9885
71095411|NCT01500096|141698990|SUPERIORITY|||||||0.2898|||||||Wilcoxon (Mann-Whitney)|2 sides Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.2898
71095412|NCT01500096|141698991|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the IL-6 level changes from baseline to week 4 are significantly different between arms.||||0.60
71095413|NCT01500096|141698991|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the IL-6 level changes from baseline to week 4 are significantly different between arms.||||0.28
71095414|NCT01500096|141698991|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the sTNFR1 level changes from baseline to week 4 are significantly different between arms.||||0.41
71095415|NCT01500096|141698991|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the sTNFR1 level changes from baseline to week 4 are significantly different between arms.||||0.72
71095416|NCT01500096|141698991|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the sTNFR2 level changes from baseline to week 4 are significantly different between arms.||||0.34
71095417|NCT01500096|141698991|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the sTNFR2 level changes from baseline to week 4 are significantly different between arms.||||0.58
71095418|NCT01500096|141698992|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 5 are significantly different between arms.||||0.31
70921730|NCT02554786|141333821|SUPERIORITY||LS Mean|0.259|STANDARD_ERROR_OF_MEAN|0.0224|<|0.001|TWO_SIDED|95.0|0.215|0.303|||MMRM|||Day 183: 30 minutes||0.303|0.215|<0.001
70921731|NCT02554786|141333821|SUPERIORITY||LS Mean|0.04|STANDARD_ERROR_OF_MEAN|0.0221||0.071|TWO_SIDED|95.0|-0.003|0.083|||MMRM|||Day 183: 30 minutes||0.083|-0.003|0.071
70921732|NCT02554786|141333821|SUPERIORITY||LS Mean|0.18|STANDARD_ERROR_OF_MEAN|0.0219|<|0.001|TWO_SIDED|95.0|0.137|0.223|||MMRM|||Day 183: 1 hour||0.223|0.137|<0.001
70921733|NCT02554786|141333821|SUPERIORITY||LS Mean|0.259|STANDARD_ERROR_OF_MEAN|0.0222|<|0.001|TWO_SIDED|95.0|0.215|0.302|||MMRM|||Day 183: 1 hour||0.302|0.215|<0.001
70921734|NCT02554786|141333821|SUPERIORITY||LS Mean|0.039|STANDARD_ERROR_OF_MEAN|0.0218||0.071|TWO_SIDED|95.0|-0.003|0.082|||MMRM|||Day 183: 1 hour||0.082|-0.003|0.071
70921735|NCT02554786|141333821|SUPERIORITY||LS Mean|0.139|STANDARD_ERROR_OF_MEAN|0.0229|<|0.001|TWO_SIDED|95.0|0.094|0.184|||MMRM|||Day 364: 5 minutes||0.184|0.094|<0.001
70921736|NCT02554786|141333821|SUPERIORITY||LS Mean|0.249|STANDARD_ERROR_OF_MEAN|0.0228|<|0.001|TWO_SIDED|95.0|0.205|0.294|||MMRM|||Day 364: 5 minutes||0.294|0.205|<0.001
70921737|NCT02554786|141333821|SUPERIORITY||LS Mean|0.026|STANDARD_ERROR_OF_MEAN|0.0227||0.244|TWO_SIDED|95.0|-0.018|0.071|||MMRM|||Day 364: 5 minutes||0.071|-0.018|0.244
70921738|NCT02554786|141333821|SUPERIORITY||LS Mean|0.155|STANDARD_ERROR_OF_MEAN|0.0228|<|0.001|TWO_SIDED|95.0|0.11|0.2|||MMRM|||Day 364: 30 minutes||0.200|0.110|<0.001
70921739|NCT02554786|141333821|SUPERIORITY||LS Mean|0.264|STANDARD_ERROR_OF_MEAN|0.0227|<|0.001|TWO_SIDED|95.0|0.219|0.308|||MMRM|||Day 364: 30 minutes||0.308|0.219|<0.001
70921740|NCT02554786|141333821|SUPERIORITY||LS Mean|0.032|STANDARD_ERROR_OF_MEAN|0.0226||0.162|TWO_SIDED|95.0|-0.013|0.076|||MMRM|||Day 364: 30 minutes||0.076|-0.013|0.162
70921741|NCT02554786|141333821|SUPERIORITY||LS Mean|0.163|STANDARD_ERROR_OF_MEAN|0.0234|<|0.001|TWO_SIDED|95.0|0.117|0.209|||MMRM|||Day 364: 1 hour||0.209|0.117|<0.001
70921742|NCT02554786|141333821|SUPERIORITY||LS Mean|0.262|STANDARD_ERROR_OF_MEAN|0.0232|<|0.001|TWO_SIDED|95.0|0.216|0.308|||MMRM|||Day 364: 1 hour||0.308|0.216|<0.001
70921743|NCT02554786|141333821|SUPERIORITY||LS Mean|0.031|STANDARD_ERROR_OF_MEAN|0.0231||0.182|TWO_SIDED|95.0|-0.014|0.076|||MMRM|||Day 364: 1 hour||0.076|-0.014|0.182
70921744|NCT02554786|141333822|SUPERIORITY||LS Mean|0.086|STANDARD_ERROR_OF_MEAN|0.0237|<|0.001|TWO_SIDED|95.0|0.04|0.133|||MMRM|||Day 2||0.133|0.040|<0.001
70921745|NCT02554786|141333822|SUPERIORITY||LS Mean|0.139|STANDARD_ERROR_OF_MEAN|0.0235|<|0.001|TWO_SIDED|95.0|0.093|0.185|||MMRM|||Day 2||0.185|0.093|<0.001
70921746|NCT02554786|141333822|SUPERIORITY||LS Mean|-0.002|STANDARD_ERROR_OF_MEAN|0.0237||0.927|TWO_SIDED|95.0|-0.049|0.044|||MMRM|||Day 2||0.044|-0.049|0.927
70921747|NCT02554786|141333822|SUPERIORITY||LS Mean|0.05|STANDARD_ERROR_OF_MEAN|0.0246||0.044|TWO_SIDED|95.0|0.001|0.098|||MMRM|||Day 184||0.098|0.001|0.044
70921748|NCT02554786|141333822|SUPERIORITY||LS Mean|0.141|STANDARD_ERROR_OF_MEAN|0.0246|<|0.001|TWO_SIDED|95.0|0.093|0.19|||MMRM|||Day 184||0.190|0.093|<0.001
70921749|NCT02554786|141333822|SUPERIORITY||LS Mean|0.017|STANDARD_ERROR_OF_MEAN|0.0244||0.49|TWO_SIDED|95.0|-0.031|0.065|||MMRM|||Day 184||0.065|-0.031|0.490
70921750|NCT02554786|141333822|SUPERIORITY||LS Mean|0.076|STANDARD_ERROR_OF_MEAN|0.0249||0.002|TWO_SIDED|95.0|0.027|0.125|||MMRM|||Day 365||0.125|0.027|0.002
70921751|NCT02554786|141333822|SUPERIORITY||LS Mean|0.146|STANDARD_ERROR_OF_MEAN|0.0248|<|0.001|TWO_SIDED|95.0|0.098|0.195|||MMRM|||Day 365||0.195|0.098|<0.001
70921752|NCT02554786|141333822|SUPERIORITY||LS Mean|0.036|STANDARD_ERROR_OF_MEAN|0.0248||0.143|TWO_SIDED|95.0|-0.012|0.085|||MMRM|||Day 365||0.085|-0.012|0.143
70921753|NCT02554786|141333823|SUPERIORITY||LS Mean|0.189|STANDARD_ERROR_OF_MEAN|0.0253|<|0.001|TWO_SIDED|95.0|0.139|0.238|||MMRM|||Day 2||0.238|0.139|<0.001
70921754|NCT02554786|141333823|SUPERIORITY||LS Mean|0.21|STANDARD_ERROR_OF_MEAN|0.025|<|0.001|TWO_SIDED|95.0|0.161|0.259|||MMRM|||Day 2||0.259|0.161|<0.001
70921755|NCT02554786|141333823|SUPERIORITY||LS Mean|-0.018|STANDARD_ERROR_OF_MEAN|0.0252||0.475|TWO_SIDED|95.0|-0.067|0.031|||MMRM|||Day 2||0.031|-0.067|0.475
70921756|NCT02554786|141333823|SUPERIORITY||LS Mean|0.228|STANDARD_ERROR_OF_MEAN|0.0345|<|0.001|TWO_SIDED|95.0|0.161|0.296|||MMRM|||Day 184||0.296|0.161|<0.001
70921757|NCT02554786|141333823|SUPERIORITY||LS Mean|0.265|STANDARD_ERROR_OF_MEAN|0.0346|<|0.001|TWO_SIDED|95.0|0.197|0.333|||MMRM|||Day 184||0.333|0.197|<0.001
70921758|NCT02554786|141333823|SUPERIORITY||LS Mean|0.083|STANDARD_ERROR_OF_MEAN|0.0343||0.015|TWO_SIDED|95.0|0.016|0.151|||MMRM|||Day 184||0.151|0.016|0.015
70921759|NCT02554786|141333823|SUPERIORITY||LS Mean|0.215|STANDARD_ERROR_OF_MEAN|0.0358|<|0.001|TWO_SIDED|95.0|0.145|0.285|||MMRM|||Day 365||0.285|0.145|<0.001
70921760|NCT02554786|141333823|SUPERIORITY||LS Mean|0.246|STANDARD_ERROR_OF_MEAN|0.0357|<|0.001|TWO_SIDED|95.0|0.176|0.316|||MMRM|||Day 365||0.316|0.176|<0.001
70921761|NCT02554786|141333823|SUPERIORITY||LS Mean|0.053|STANDARD_ERROR_OF_MEAN|0.0356||0.139|TWO_SIDED|95.0|-0.017|0.122|||MMRM|||Day 365||0.122|-0.017|0.139
70921762|NCT02554786|141333824|SUPERIORITY||LS Mean|29.6|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|23.8|35.4|||Linear Mixed Model (LMM)|||Week 26: Mean morning PEF||35.4|23.8|<0.001
70974525|NCT02475655|141455776|SUPERIORITY||Mean Difference (Net)|-1.33||||0.01|TWO_SIDED|90.0|-2.16|-0.5||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CX3CR1+ among CD4+ T-cells from Entry to Week 5.||-0.50|-2.16|0.010
70974526|NCT02475655|141455776|SUPERIORITY||Mean Difference (Net)|-0.17||||0.74|TWO_SIDED|90.0|-1.02|0.68||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CX3CR1+ among CD4+ T-cells from Entry to Week 12.||0.68|-1.02|0.74
70974527|NCT02475655|141455777|SUPERIORITY||Mean Difference (Net)|-3.24||||0.008|TWO_SIDED|90.0|-5.22|-1.27||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD8+ T-cells from Entry to Week 5.||-1.27|-5.22|0.008
70974528|NCT02475655|141455777|SUPERIORITY||Median Difference (Net)|-0.17||||0.9|TWO_SIDED|90.0|-2.38|2.05||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD8+ T-cells from Entry to Week 12.||2.05|-2.38|0.90
70974529|NCT02475655|141455780|SUPERIORITY||Mean Difference (Net)|1.39||||0.47|TWO_SIDED|90.0|-1.83|4.61||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) from Entry to Week 5.||4.61|-1.83|0.47
70974530|NCT02475655|141455780|SUPERIORITY||Mean Difference (Net)|2.21||||0.22|TWO_SIDED|90.0|-0.77|5.18||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) from Entry to Week 12.||5.18|-0.77|0.22
70974531|NCT02475655|141455781|SUPERIORITY||Mean Difference (Net)|-4.34||||0.28|TWO_SIDED|90.0|-11.0|2.35||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CD163+ from Entry to Week 5.||2.35|-11.0|0.28
70974532|NCT02475655|141455781|SUPERIORITY||Mean Difference (Net)|-9.81||||0.019|TWO_SIDED|90.0|-16.6|-3.02||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CD163+ from Entry to Week 12.||-3.02|-16.6|0.019
70974533|NCT02475655|141455782|SUPERIORITY||Mean Difference (Net)|-0.81||||0.55|TWO_SIDED|90.0|-3.02|1.41||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CCR2+ from Entry to Week 5.||1.41|-3.02|0.55
70974534|NCT02475655|141455782|SUPERIORITY||Mean Difference (Net)|-1.7||||0.09|TWO_SIDED|90.0|-3.36|-0.04||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CCR2+ from Entry to Week 12.||-0.04|-3.36|0.09
70974535|NCT02475655|141455783|SUPERIORITY||Mean Difference (Net)|-1.47||||0.15|TWO_SIDED|90.0|-3.17|0.23||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CX3CR1+ from Entry to Week 5.||0.23|-3.17|0.15
70974536|NCT02475655|141455783|SUPERIORITY||Mean Difference (Net)|-1.62||||0.37|TWO_SIDED|90.0|-4.59|1.35||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CX3CR1+ from Entry to Week 12.||1.35|-4.59|0.37
70974537|NCT02475655|141455784|SUPERIORITY||Mean Difference (Net)|-0.86||||0.39|TWO_SIDED|90.0|-2.51|0.8||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) from Entry to Week 5.||0.80|-2.51|0.39
70974538|NCT02475655|141455784|SUPERIORITY||Mean Difference (Net)|-0.7||||0.54|TWO_SIDED|90.0|-2.59|1.19||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) from Entry to Week 12.||1.19|-2.59|0.54
71095419|NCT01500096|141698992|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.71
71095420|NCT01500096|141698993|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.18
71095421|NCT01500096|141698993|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.19
71095422|NCT01500096|141698994|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.47
71095423|NCT01500096|141698994|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.41
71033507|NCT00185458|141577112|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
71033508|NCT00185458|141577113|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
71033509|NCT00185458|141577114|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
71033510|NCT00185458|141577115|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
71033511|NCT00185458|141577116|SUPERIORITY_OR_OTHER|||||||0.175||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||0.175
71033512|NCT00185458|141577117|SUPERIORITY_OR_OTHER|||||||0.062||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||0.062
71033513|NCT00185458|141577118|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
71033514|NCT00835536|141577151|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.0||||||90.0|93.1|108.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108|93.1|
71033515|NCT00835536|141577152|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.5||||||90.0|92.1|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101|92.1|
71095424|NCT01952678|141699000|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|TWO_SIDED|95.0|-17.3|20.7|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.7|-17.3|1.0000
71095425|NCT01952678|141699000|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|-7.0||||0.4608|TWO_SIDED|95.0|-25.8|12.1|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||12.1|-25.8|0.4608
71095426|NCT01952678|141699000|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|TWO_SIDED|95.0|-17.3|20.7|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.7|-17.3|1.0000
71095427|NCT01952678|141699000|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|TWO_SIDED|95.0|-17.3|20.7|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.7|-17.3|1.0000
71095428|NCT01952678|141699001|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|TWO_SIDED|95.0|-17.5|20.9|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.9|-17.5|1.0000
71095429|NCT01952678|141699001|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|-7.1||||0.4599|TWO_SIDED|95.0|-26.1|12.2|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||12.2|-26.1|0.4599
71095430|NCT01952678|141699001|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|TWO_SIDED|95.0|-17.5|20.9|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.9|-17.5|1.0000
71033516|NCT03769025|141577171|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||.1
71033517|NCT03769025|141577172|SUPERIORITY|||||||0.959|||||||t-test, 2 sided|||||||.959
71033518|NCT03482882|141577208|OTHER||LSM|-10.8|STANDARD_ERROR_OF_MEAN|0.63|<|0.0001|TWO_SIDED|95.0|-12.0|-9.5|||Mixed-effect model repeated measures|||||-9.5|-12.0|<0.0001
71033519|NCT00913627|141577216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.16|||<|0.001|TWO_SIDED|95.0|12.13|20.19||p-value adjusted for baseline pain severity rating (PSR) and gender|ANOVA|||||20.19|12.13|<0.001
71033520|NCT00913627|141577216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.0|||<|0.001|TWO_SIDED|95.0|13.02|20.99||p-value adjusted for baseline pain severity rating (PSR) and gender|ANOVA|||||20.99|13.02|<0.001
71033521|NCT00913627|141577216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.3|||<|0.001|TWO_SIDED|95.0|8.33|16.26||p-value adjusted for baseline pain severity rating (PSR) and gender|ANOVA|||||16.26|8.33|<0.001
71033522|NCT00913627|141577217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.34|||<|0.001|TWO_SIDED|95.0|4.3|8.38||p-value adjusted for baseline PSR and gender|ANOVA|||||8.38|4.30|<0.001
71033523|NCT00913627|141577217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.06|||<|0.001|TWO_SIDED|95.0|5.05|9.08||p-value adjusted for baseline PSR and gender|ANOVA|||||9.08|5.05|<0.001
71033524|NCT00913627|141577217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.05|||<|0.001|TWO_SIDED|95.0|3.04|7.06||p-value adjusted for baseline PSR and gender|ANOVA|||||7.06|3.04|<0.001
71033525|NCT00913627|141577220|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-72.19|||<|0.001|TWO_SIDED|95.0|-88.56|-55.83||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|8 hours||-55.83|-88.56|<0.001
71095431|NCT01952678|141699001|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|TWO_SIDED|95.0|-17.5|20.9|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.9|-17.5|1.0000
70974539|NCT02475655|141455785|SUPERIORITY||Mean Difference (Net)|-6.02||||0.1|TWO_SIDED|90.0|-12.0|-0.06||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CD163+ from Entry to Week 5.||-0.06|-12.0|0.10
70974540|NCT02475655|141455785|SUPERIORITY||Mean Difference (Net)|-6.39||||0.026|TWO_SIDED|90.0|-11.1|-1.73||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CD163+ from Entry to Week 12.||-1.73|-11.1|0.026
70974541|NCT02475655|141455786|SUPERIORITY||Mean Difference (Net)|0.28||||0.95|TWO_SIDED|90.0|-7.26|7.82||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CCR2+ from Entry to Week 5.||7.82|-7.26|0.95
70974542|NCT02475655|141455786|SUPERIORITY||Mean Difference (Net)|-4.1||||0.43|TWO_SIDED|90.0|-12.6|4.45||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CCR2+ from Entry to Week 12.||4.45|-12.6|0.43
70974543|NCT02475655|141455787|SUPERIORITY||Mean Difference (Net)|1.23||||0.74|TWO_SIDED|90.0|-5.08|7.54||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CX3CR1+ from Entry to Week 5.||7.54|-5.08|0.74
70974544|NCT02475655|141455787|SUPERIORITY||Mean Difference (Net)|3.76||||0.42|TWO_SIDED|90.0|-3.94|11.5||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CX3CR1+ from Entry to Week 12.||11.5|-3.94|0.42
70974545|NCT02475655|141455788|SUPERIORITY||Mean Difference (Net)|-0.63||||0.66|TWO_SIDED|90.0|-2.99|1.73||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) from Entry to Week 5.||1.73|-2.99|0.66
70974546|NCT02475655|141455788|SUPERIORITY||Mean Difference (Net)|-1.56||||0.27|TWO_SIDED|90.0|-3.93|0.8||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) from Entry to Week 12.||0.80|-3.93|0.27
70974547|NCT02475655|141455789|SUPERIORITY||Mean Difference (Net)|-7.1||||0.013|TWO_SIDED|90.0|-11.7|-2.46||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CD163+ from Entry to Week 5.||-2.46|-11.7|0.013
70974548|NCT02475655|141455789|SUPERIORITY||Mean Difference (Net)|-1.49||||0.7|TWO_SIDED|90.0|-8.06|5.07||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CD163+ from Entry to Week 12.||5.07|-8.06|0.70
70974549|NCT02475655|141455790|SUPERIORITY||Mean Difference (Net)|0.01||||0.79|TWO_SIDED|90.0|-0.05|0.07||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CCR2+ from Entry to Week 5.||0.07|-0.05|0.79
70974550|NCT02475655|141455790|SUPERIORITY||Mean Difference (Net)|0.01||||0.91|TWO_SIDED|90.0|-0.07|0.08||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CCR2+ from Entry to Week 12.||0.08|-0.07|0.91
71033526|NCT00913627|141577220|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-70.72|||<|0.001|TWO_SIDED|95.0|-87.14|-54.3||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|8 hours||-54.30|-87.14|<0.001
71033527|NCT00913627|141577220|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-59.6|||<|0.001|TWO_SIDED|95.0|-76.94|-42.27||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|8 hours||-42.27|-76.94|<0.001
71033528|NCT00913627|141577220|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-72.19|||<|0.001|TWO_SIDED|95.0|-88.56|-55.83||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|9 hours||-55.83|-88.56|<0.001
71033529|NCT00913627|141577220|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-70.72|||<|0.001|TWO_SIDED|95.0|-87.14|-54.3||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|9 hours||-54.30|-87.14|<0.001
71033530|NCT00913627|141577220|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-57.79|||<|0.001|TWO_SIDED|95.0|-75.43|-40.16||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|9 hours||-40.16|-75.43|<0.001
70974551|NCT02475655|141455791|SUPERIORITY||Mean Difference (Net)|-2.85||||0.43|TWO_SIDED|90.0|-8.82|3.12||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CX3CR1+ from Entry to Week 5.||3.12|-8.82|0.43
70974552|NCT02475655|141455791|SUPERIORITY||Mean Difference (Net)|0.03||||0.99|TWO_SIDED|90.0|-6.53|6.6||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CX3CR1+ from Entry to Week 12.||6.60|-6.53|0.99
70974553|NCT02475655|141455792|SUPERIORITY||Median Difference (Net)|1.88||||0.007|TWO_SIDED|90.0|1.29|2.73||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Cellular HIV-1 DNA from entry to Week 5.||2.73|1.29|0.007
70974554|NCT02475655|141455792|SUPERIORITY||Mean Difference (Net)|1.31||||0.23|TWO_SIDED|90.0|0.9|1.9||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Cellular HIV-1 DNA from entry to Week 12.||1.90|0.90|0.23
70974555|NCT02475655|141455793|SUPERIORITY||Mean Difference (Net)|1.22||||0.32|TWO_SIDED|90.0|0.87|1.72||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in cellular HIV-1 total RNA from entry to Week 5.||1.72|0.87|0.32
70974556|NCT02475655|141455793|SUPERIORITY||Mean Difference (Net)|1.03||||0.91|TWO_SIDED|90.0|0.68|1.56||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in cellular HIV-1 total RNA from entry to Week 12.||1.56|0.68|0.91
70974557|NCT02475655|141455794|SUPERIORITY|||||||0.4||||||Not adjusted for multiple comparisons. Two-sided 10% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in the percentage of participants with detectable CMV at any on-treatment time point (ever shedding at weeks 1, 2, 4, or 5).||||0.40
70974558|NCT02475655|141455794|SUPERIORITY|||||||0.87||||||Not adjusted for multiple comparisons. Two-sided 10% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in the percentage of participants with detectable CMV at any post-treatment time point (ever shedding at weeks 10 or 12).||||0.87
71033531|NCT00913627|141577220|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-66.79|||<|0.001|TWO_SIDED|95.0|-83.98|-49.6||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|10 hours||-49.60|-83.98|<0.001
71033532|NCT00913627|141577220|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-70.72|||<|0.001|TWO_SIDED|95.0|-87.14|-54.3||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|10 hours||-54.30|-87.14|<0.001
71033533|NCT00913627|141577220|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-55.98|||<|0.001|TWO_SIDED|95.0|-73.85|-38.11||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|10 hours||-38.11|-73.85|<0.001
70974559|NCT02475655|141455798|SUPERIORITY||Mean Difference (Net)|0.53||||0.4|TWO_SIDED|90.0|0.15|1.88||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Integrated DNA from entry to Week 5.||1.88|0.15|0.40
70974560|NCT02475655|141455798|SUPERIORITY||Mean Difference (Net)|0.92||||0.93|TWO_SIDED|90.0|0.2|4.34||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Integrated DNA from entry to Week 12.||4.34|0.20|0.93
70974561|NCT03545906|141455807|SUPERIORITY||Mean Difference (Net)|1.0||||0.075|TWO_SIDED||||||t-test, 2 sided|||||||.075
70974562|NCT03545906|141455808|SUPERIORITY||Mean Difference (Net)|1.3||||0.018|TWO_SIDED||||||t-test, 2 sided|||||||.018
70974563|NCT03545906|141455809|SUPERIORITY||Mean Difference (Net)|1.2||||0.039|TWO_SIDED||||||t-test, 2 sided|||||||.039
70974564|NCT03545906|141455810|SUPERIORITY||Mean Difference (Net)|0.7||||0.265|TWO_SIDED||||||t-test, 2 sided|||||||.265
71033534|NCT00913627|141577220|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-63.44|||<|0.001|TWO_SIDED|95.0|-80.82|-46.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||11 hours||-46.06|-80.82|<0.001
71033535|NCT00913627|141577220|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-68.88|||<|0.001|TWO_SIDED|95.0|-85.63|-54.14||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||11 hours||-54.14|-85.63|<0.001
71033536|NCT00913627|141577220|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-55.98|||<|0.001|TWO_SIDED|95.0|-73.85|-38.11||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||11 hours||-38.11|-73.85|<0.001
70921763|NCT02554786|141333824|SUPERIORITY||LS Mean|32.2|STANDARD_ERROR_OF_MEAN|2.97|<|0.001|TWO_SIDED|95.0|26.4|38.1|||LMM|||Week 26: Mean morning PEF||38.1|26.4|<0.001
70921764|NCT02554786|141333824|SUPERIORITY||LS Mean|13.3|STANDARD_ERROR_OF_MEAN|2.97|<|0.001|TWO_SIDED|95.0|7.5|19.1|||LMM|||Week 26: Mean morning PEF||19.1|7.5|<0.001
70921765|NCT02554786|141333824|SUPERIORITY||LS Mean|24.8|STANDARD_ERROR_OF_MEAN|2.82|<|0.001|TWO_SIDED|95.0|19.3|30.3|||LMM|||Week 26: Mean evening PEF||30.3|19.3|<0.001
70921766|NCT02554786|141333824|SUPERIORITY||LS Mean|30.4|STANDARD_ERROR_OF_MEAN|2.83|<|0.001|TWO_SIDED|95.0|24.8|35.9|||LMM|||Week 26: Mean evening PEF||35.9|24.8|<0.001
70921767|NCT02554786|141333824|SUPERIORITY||LS Mean|8.6|STANDARD_ERROR_OF_MEAN|2.83||0.002|TWO_SIDED|95.0|3.1|14.2|||LMM|||Week 26: Mean evening PEF||14.2|3.1|0.002
70921768|NCT02554786|141333824|SUPERIORITY||LS Mean|28.7|STANDARD_ERROR_OF_MEAN|3.07|<|0.001|TWO_SIDED|95.0|22.7|34.8|||LMM|||Week 52: Mean morning PEF||34.8|22.7|<0.001
70921769|NCT02554786|141333824|SUPERIORITY||LS Mean|30.2|STANDARD_ERROR_OF_MEAN|3.07|<|0.001|TWO_SIDED|95.0|24.2|36.3|||LMM|||Week 52: Mean morning PEF||36.3|24.2|<0.001
70921770|NCT02554786|141333824|SUPERIORITY||LS Mean|13.8|STANDARD_ERROR_OF_MEAN|3.08|<|0.001|TWO_SIDED|95.0|7.7|19.8|||LMM|||Week 52: Mean morning PEF||19.8|7.7|<0.001
70921771|NCT02554786|141333824|SUPERIORITY||LS Mean|23.7|STANDARD_ERROR_OF_MEAN|2.94|<|0.001|TWO_SIDED|95.0|18.0|29.5|||LMM|||Week 52: Mean evening PEF||29.5|18.0|<0.001
70921772|NCT02554786|141333824|SUPERIORITY||LS Mean|29.1|STANDARD_ERROR_OF_MEAN|2.94|<|0.001|TWO_SIDED|95.0|23.3|34.8|||LMM|||Week 52: Mean evening PEF||34.8|23.3|<0.001
70921773|NCT02554786|141333824|SUPERIORITY||LS Mean|9.1|STANDARD_ERROR_OF_MEAN|2.95||0.002|TWO_SIDED|95.0|3.3|14.9|||LMM|||Week 52: Mean evening PEF||14.9|3.3|0.002
70921774|NCT02554786|141333825|SUPERIORITY||Odds Ratio (OR)|1.31||||0.094|TWO_SIDED|95.0|0.95|1.81|||Logistic regression model|||Day 183||1.81|0.95|0.094
70921775|NCT02554786|141333825|SUPERIORITY||Odds Ratio (OR)|1.73|||<|0.001|TWO_SIDED|95.0|1.26|2.37|||Logistic regression model|||Day 183||2.37|1.26|<0.001
70921776|NCT02554786|141333825|SUPERIORITY||Odds Ratio (OR)|1.06||||0.746|TWO_SIDED|95.0|0.76|1.46|||Logistic regression model|||Day 183||1.46|0.76|0.746
70921777|NCT02554786|141333825|SUPERIORITY||Odds Ratio (OR)|1.34||||0.088|TWO_SIDED|95.0|0.96|1.87|||Logistic regression model|||Day 364||1.87|0.96|0.088
71033537|NCT00913627|141577220|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-63.44|||<|0.001|TWO_SIDED|95.0|-80.82|-46.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||12 hours||-46.06|-80.82|<0.001
70921778|NCT02554786|141333825|SUPERIORITY||Odds Ratio (OR)|2.24|||<|0.001|TWO_SIDED|95.0|1.58|3.17|||Logistic regression model|||Day 364||3.17|1.58|<0.001
70921779|NCT02554786|141333825|SUPERIORITY||Odds Ratio (OR)|1.05||||0.771|TWO_SIDED|95.0|0.75|1.49|||Logistic regression model|||Day 364||1.49|0.75|0.771
70921780|NCT02554786|141333826|SUPERIORITY||LS Mean|5.8|STANDARD_ERROR_OF_MEAN|2.29||0.012|TWO_SIDED|95.0|1.3|10.2|||Linear Mixed Model (LMM)|||||10.2|1.3|0.012
70921781|NCT02554786|141333826|SUPERIORITY||LS Mean|9.1|STANDARD_ERROR_OF_MEAN|2.29|<|0.001|TWO_SIDED|95.0|4.6|13.6|||LMM|||||13.6|4.6|<0.001
70921782|NCT02554786|141333826|SUPERIORITY||LS Mean|3.4|STANDARD_ERROR_OF_MEAN|2.29||0.135|TWO_SIDED|95.0|-1.1|7.9|||LMM|||||7.9|-1.1|0.135
70921783|NCT02554786|141333827|SUPERIORITY||LS Mean|5.0|STANDARD_ERROR_OF_MEAN|2.25||0.026|TWO_SIDED|95.0|0.6|9.4|||LMM|||||9.4|0.6|0.026
70921784|NCT02554786|141333827|SUPERIORITY||LS Mean|8.1|STANDARD_ERROR_OF_MEAN|2.25|<|0.001|TWO_SIDED|95.0|3.7|12.5|||LMM|||||12.5|3.7|<0.001
70921785|NCT02554786|141333827|SUPERIORITY||LS Mean|3.2|STANDARD_ERROR_OF_MEAN|2.25||0.151|TWO_SIDED|95.0|-1.2|7.7|||LMM|||||7.7|-1.2|0.151
70921786|NCT02554786|141333828|SUPERIORITY||LS Mean|2.8|STANDARD_ERROR_OF_MEAN|1.72||0.104|TWO_SIDED|95.0|-0.6|6.2|||LMM|||||6.2|-0.6|0.104
70921787|NCT02554786|141333828|SUPERIORITY||LS Mean|3.9|STANDARD_ERROR_OF_MEAN|1.72||0.024|TWO_SIDED|95.0|0.5|7.3|||LMM|||||7.3|0.5|0.024
71033538|NCT00913627|141577220|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-65.28|||<|0.001|TWO_SIDED|95.0|-82.49|-48.07||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||12 hours||-48.07|-82.49|<0.001
71033539|NCT00913627|141577220|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-50.77|||<|0.001|TWO_SIDED|95.0|-69.09|-32.45||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||12 hours||-32.45|-69.09|<0.001
70921788|NCT02554786|141333828|SUPERIORITY||LS Mean|0.9|STANDARD_ERROR_OF_MEAN|1.73||0.588|TWO_SIDED|95.0|-2.5|4.3|||LMM|||||4.3|-2.5|0.588
70921789|NCT02554786|141333829|SUPERIORITY||LS Mean|6.4|STANDARD_ERROR_OF_MEAN|2.19||0.003|TWO_SIDED|95.0|2.1|10.7|||LMM|||||10.7|2.1|0.003
70921790|NCT02554786|141333829|SUPERIORITY||LS Mean|8.9|STANDARD_ERROR_OF_MEAN|2.19|<|0.001|TWO_SIDED|95.0|4.6|13.2|||LMM|||||13.2|4.6|<0.001
70921791|NCT02554786|141333829|SUPERIORITY||LS Mean|4.8|STANDARD_ERROR_OF_MEAN|2.2||0.029|TWO_SIDED|95.0|0.5|9.1|||LMM|||||9.1|0.5|0.029
70921792|NCT02554786|141333830|SUPERIORITY||LS Mean|-0.13|STANDARD_ERROR_OF_MEAN|0.039||0.001|TWO_SIDED|95.0|-0.2|-0.05|||LMM|||Week1-26 Mean night-time number of puffs||-0.05|-0.2|0.001
70921793|NCT02554786|141333830|SUPERIORITY||LS Mean|-0.08|STANDARD_ERROR_OF_MEAN|0.039||0.035|TWO_SIDED|95.0|-0.16|-0.01|||LMM|||Week 1-26 Mean night-time number of puffs||-0.01|-0.16|0.035
70921794|NCT02554786|141333830|SUPERIORITY||LS Mean|-0.04|STANDARD_ERROR_OF_MEAN|0.039||0.261|TWO_SIDED|95.0|-0.12|0.03|||LMM|||Week 1-26 Mean night-time number of puffs||0.03|-0.12|0.261
70921795|NCT02554786|141333830|SUPERIORITY||LS Mean|-0.19|STANDARD_ERROR_OF_MEAN|0.047|<|0.001|TWO_SIDED|95.0|-0.28|-0.09|||LMM|||Week 1-26 Mean daytime number of puffs||-0.09|-0.28|<0.001
71033540|NCT00913627|141577221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.34|||<|0.001|TWO_SIDED|95.0|4.18|6.51||p-value adjusted for baseline PSR, and gender|ANOVA|||SPID 0-4||6.51|4.18|<0.001
71033541|NCT00913627|141577221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.25|||<|0.001|TWO_SIDED|95.0|4.09|6.4||p-value adjusted for baseline PSR and gender|ANOVA|||SPID 0-4||6.40|4.09|<0.001
70974565|NCT00353418|141455811|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.6119||95.0|0.68|1.93|||Cochran-Mantel-Haenszel|||"Sample sizes of 133 and 267 patients for RBV 800 mg daily and RBV 1000 or 1200 mg daily, respectively, provided the following probabilities of detecting the specified differences in SVR with a 0.05 level two-sided chi-square test of significance:~RBV 800 mg SVR - 0.30; RBV 1000 or 1200 mg SVR - 0.40; Probability - 0.49~RBV 800 mg SVR - 0.30; RBV 1000 or 1200 mg SVR - 0.45; Probability - 0.83"||1.93|0.68|0.6119
71033542|NCT00913627|141577221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.98|||<|0.001|TWO_SIDED|95.0|2.83|5.12||p-value adjusted for baseline PSR and gender|ANOVA|||SPID 0-4||5.12|2.83|<0.001
71033543|NCT00913627|141577221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.53|||<|0.001|TWO_SIDED|95.0|5.63|9.43||p-value adjusted for baseline PSR and gender|ANOVA|||SPID 4-8||9.43|5.63|<0.001
71033544|NCT00913627|141577221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.68|||<|0.001|TWO_SIDED|95.0|5.8|9.56||p-value adjusted for baseline PSR and gender|ANOVA|||SPID 4-8||9.56|5.80|<0.001
71033545|NCT00913627|141577221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.49|||<|0.001|TWO_SIDED|95.0|3.62|7.36||p-value adjusted for baseline PSR and gender|ANOVA|||SPID 4-8||7.36|3.62|<0.001
71033546|NCT00913627|141577222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.47|||<|0.001|TWO_SIDED|95.0|10.68|16.27||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-4||16.27|10.68|<0.001
71033547|NCT00913627|141577222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.24|||<|0.001|TWO_SIDED|95.0|10.48|16.01||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-4||16.01|10.48|<0.001
71033548|NCT00913627|141577222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.08|||<|0.001|TWO_SIDED|95.0|7.33|12.83||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-4||12.83|7.33|<0.001
71033549|NCT00913627|141577222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.21|||<|0.001|TWO_SIDED|95.0|14.71|23.71||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 4-8||23.71|14.71|<0.001
71033550|NCT00913627|141577222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.32|||<|0.001|TWO_SIDED|95.0|14.86|23.78||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 4-8||23.78|14.86|<0.001
71033551|NCT00913627|141577222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.87|||<|0.001|TWO_SIDED|95.0|9.44|18.3||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 4-8||18.30|9.44|<0.001
71033552|NCT00913627|141577222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.18|||<|0.001|TWO_SIDED|95.0|11.29|21.07||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 8-12||21.07|11.29|<0.001
71033553|NCT00913627|141577222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.65|||<|0.001|TWO_SIDED|95.0|12.81|22.49||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 8-12||22.49|12.81|<0.001
71033554|NCT00913627|141577222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.78|||<|0.001|TWO_SIDED|95.0|7.97|17.59||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 8-12||17.59|7.97|<0.001
71033555|NCT00913627|141577222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.08|||<|0.001|TWO_SIDED|95.0|31.48|50.69||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-12||50.69|31.48|<0.001
71033556|NCT00913627|141577222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.66|||<|0.001|TWO_SIDED|95.0|33.15|52.17||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-12||52.17|33.15|<0.001
71033557|NCT00913627|141577222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.08|||<|0.001|TWO_SIDED|95.0|21.63|40.53||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-12||40.53|21.63|<0.001
71033558|NCT00913627|141577223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.13|||<|0.001|TWO_SIDED|95.0|6.45|9.8||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-4||9.80|6.45|<0.001
71033559|NCT00913627|141577223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.99|||<|0.001|TWO_SIDED|95.0|6.34|9.65||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-4||9.65|6.34|<0.001
71033560|NCT00913627|141577223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.11|||<|0.001|TWO_SIDED|95.0|4.46|7.75||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-4||7.75|4.46|<0.001
71033561|NCT00913627|141577223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.68|||<|0.001|TWO_SIDED|95.0|9.02|14.34||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 4-8||14.34|9.02|<0.001
71033562|NCT00913627|141577223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.64|||<|0.001|TWO_SIDED|95.0|9.01|14.27||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 4-8||14.27|9.01|<0.001
71033563|NCT00913627|141577223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.38|||<|0.001|TWO_SIDED|95.0|5.76|11.0||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 4-8||11.00|5.76|<0.001
71033564|NCT00913627|141577223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.84|||<|0.001|TWO_SIDED|95.0|6.93|12.75||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 8-12||12.75|6.93|<0.001
71033565|NCT00913627|141577223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.59|||<|0.001|TWO_SIDED|95.0|7.71|13.46||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 8-12||13.46|7.71|<0.001
71033566|NCT00913627|141577223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.73|||<|0.001|TWO_SIDED|95.0|4.87|10.59||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 8-12||10.59|4.87|<0.001
71033567|NCT00913627|141577223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.93|||<|0.001|TWO_SIDED|95.0|19.24|30.61||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-12||30.61|19.24|<0.001
71033568|NCT00913627|141577223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.66|||<|0.001|TWO_SIDED|95.0|20.03|31.28||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-12||31.28|20.03|<0.001
71033569|NCT00913627|141577223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.78|||<|0.001|TWO_SIDED|95.0|13.19|24.38||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-12||24.38|13.19|<0.001
71033570|NCT00913627|141577224|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.31||||0.08|TWO_SIDED|95.0|1.26|25.36||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||15 minutes||25.36|1.26|0.080
71033571|NCT00913627|141577224|SUPERIORITY_OR_OTHER||CMH adjusted proportions|16.39||||0.043|TWO_SIDED|95.0|3.73|29.04||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||15 minutes||29.04|3.73|0.043
71095432|NCT01952678|141699002|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.0||||1|TWO_SIDED|95.0|-22.0|22.0|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||22.0|-22.0|1.0000
71154273|NCT04972162|141801174|OTHER|The rm-ANOVA model fitted for the primary analysis was run to confirm if there is a significant interaction for treatment and order. This confirmation of the absence of an interaction effect is needed to validate the pooling of the two periods of Web-App treatment and the two periods of Standard-of-Care treatment, respectively.||||||0.38||||||p\<0.05 would show that there is an interaction effect i.e. results would differ depending on the order in which the participants wore the hearing aids|ANOVA|||"Check for interaction effect for Ease of Communication Subscale (EC)~The statistical analysis method was a repeated-measures ANOVA in which:~* order is a between-subjects effect - i.e., each subject has just one order~* treatment is a within-subjects effect - i.e., each subjects has both treatments because of the cross-over design~* the interaction term treatment x order is a within-subjects effect. The rm-ANOVAs generates a nuisance p-value: that of the interaction effect."||||0.38
71095433|NCT01952678|141699002|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.4||||1|TWO_SIDED|95.0|-20.8|20.8|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.8|-20.8|1.0000
70974566|NCT03244033|141455827|SUPERIORITY||Odds Ratio (OR)|0.97||||0.91|TWO_SIDED|96.0|0.57|1.64|||Mixed Models Analysis|Adjusted for site (p\<.001) and for whether physician contextualized plan (AOR 2.14, p=.001), and random effects of physician and patient.||Logistic mixed effects regression modeling likelihood of red flag improved/resolved (vs. not) during outcome period with fixed effects of intervention, site, and whether contextual factor was incorporated into care plan, and random effects of patient and provider. Red flags may be clustered in patients; patients are clustered in providers.||1.64|.57|.91
70974567|NCT03244033|141455828|SUPERIORITY||Odds Ratio (OR)|2.09||||0.02|TWO_SIDED|95.0|1.13|3.86|||Mixed Models Analysis|Adjusted for site, source of red flag, visible/concealed recorder, and random effects of physician and patient.|OR\>1 indicates greater likelihood in intervention group vs. control.|Logistic mixed effects regression modeling likelihood of provider probing red flag (vs. not) during visit with fixed effects of intervention, site, \\whether red flag was select on pre-visit questionnaire, and whether audiorecorder was visible to provider, and random effects of patient and provider. Red flags may be clustered in patients; patients are clustered in providers.||3.86|1.13|0.02
70974568|NCT03244033|141455829|SUPERIORITY||Odds Ratio (OR)|2.67||||0.006|TWO_SIDED|95.0|1.32|5.41|||Mixed Models Analysis|Adjusted for site, source of factor, recorder visible/concealed, and random effects of physician and patient.|OR \> 1 indicates greater likelihood in intervention group vs. control.|Logistic mixed effects regression modeling likelihood of provider incorporating contextual factor into care plan (vs. not) at visit with fixed effects of intervention, site, whether red flag was select on pre-visit questionnaire, whether audiorecorder was visible to provider, whether factor was identified by provider probe, whether factor was revealed by patient, and random effects of patient and provider. Red flags may be clustered in patients; patients are clustered in providers.||5.41|1.32|.006
70974569|NCT03021642|141455846|SUPERIORITY_OR_OTHER_LEGACY||Geometric Least square (LS) mean ratio|98.68|||||TWO_SIDED|90.0|93.67|103.96||||||||103.96|93.67|
70974570|NCT03021642|141455847|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS mean ratio|95.71|||||TWO_SIDED|90.0|88.43|103.59||||||||103.59|88.43|
71095434|NCT01952678|141699002|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|-2.0||||1|TWO_SIDED|95.0|-23.0|18.5|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||18.5|-23.0|1.0000
70921796|NCT02554786|141333830|SUPERIORITY||LS Mean|-0.12|STANDARD_ERROR_OF_MEAN|0.047||0.011|TWO_SIDED|95.0|-0.21|-0.03|||LMM|||Week 1-26 Mean daytime number of puffs||-0.03|-0.21|0.011
70921797|NCT02554786|141333830|SUPERIORITY||LS Mean|-0.04|STANDARD_DEVIATION|0.047||0.425|TWO_SIDED|95.0|-0.13|0.06|||LMM|||Week 1-26 Mean daytime number of puffs||0.06|-0.13|0.425
70921798|NCT02554786|141333830|SUPERIORITY||LS Mean|-0.31|STANDARD_ERROR_OF_MEAN|0.081|<|0.001|TWO_SIDED|95.0|-0.46|-0.15|||LMM|||Week 1-26 Mean daily number of puffs||-0.15|-0.46|<0.001
70921799|NCT02554786|141333830|SUPERIORITY||LS Mean|-0.19|STANDARD_ERROR_OF_MEAN|0.081||0.017|TWO_SIDED|95.0|-0.35|-0.03|||LMM|||Week 1-26 Mean daily number of puffs||-0.03|-0.35|0.017
70921800|NCT02554786|141333830|SUPERIORITY||LS Mean|-0.09|STANDARD_ERROR_OF_MEAN|0.081||0.29|TWO_SIDED|95.0|-0.24|-0.07|||LMM|||Week 1-26 Mean daily number of puffs||-0.07|-0.24|0.29
70921801|NCT02554786|141333830|SUPERIORITY||LS Mean|-0.11|STANDARD_ERROR_OF_MEAN|0.039||0.004|TWO_SIDED|95.0|-0.19|-0.04|||LMM|||Week 1-52 Mean night-time number of puffs||-0.04|-0.19|0.004
70921802|NCT02554786|141333830|SUPERIORITY||LS Mean|-0.09|STANDARD_ERROR_OF_MEAN|0.039||0.019|TWO_SIDED|95.0|-0.17|-0.02|||LMM|||Week 1-52 Mean night-time number of puffs||-0.02|-0.17|0.019
70921803|NCT02554786|141333830|SUPERIORITY||LS Mean|-0.05|STANDARD_ERROR_OF_MEAN|0.039||0.226|TWO_SIDED|95.0|-0.12|0.03|||LMM|||Week 1-52 Mean night-time number of puffs||0.03|-0.12|0.226
70921804|NCT02554786|141333830|SUPERIORITY||LS Mean|-0.17|STANDARD_ERROR_OF_MEAN|0.048|<|0.001|TWO_SIDED|95.0|-0.26|-0.07|||LMM|||Week 1-52 Mean daytime number of puffs||-0.07|-0.26|<0.001
70921805|NCT02554786|141333830|SUPERIORITY||LS Mean|-0.15|STANDARD_ERROR_OF_MEAN|0.048||0.002|TWO_SIDED|95.0|-0.24|-0.05|||LMM|||Week 1-52 Mean daytime number of puffs||-0.05|-0.24|0.002
70921806|NCT02554786|141333830|SUPERIORITY||LS Mean|-0.04|STANDARD_ERROR_OF_MEAN|0.048||0.384|TWO_SIDED|95.0|-0.14|0.05|||LMM|||Week 1-52 Mean daytime number of puffs||0.05|-0.14|0.384
70921807|NCT02554786|141333830|SUPERIORITY||LS Mean|-0.28|STANDARD_ERROR_OF_MEAN|0.081|<|0.001|TWO_SIDED|95.0|-0.44|-0.12|||LMM|||Week 1-52 Mean daily number of puffs||-0.12|-0.44|< 0.001
70921808|NCT02554786|141333830|SUPERIORITY||LS Mean|-0.23|STANDARD_ERROR_OF_MEAN|0.081||0.004|TWO_SIDED|95.0|-0.39|-0.07|||LMM|||Week 1-52 Mean daily number of puffs||-0.07|-0.39|0.004
70921809|NCT02554786|141333830|SUPERIORITY||LS Mean|-0.09|STANDARD_ERROR_OF_MEAN|0.081||0.245|TWO_SIDED|95.0|-0.25|0.06|||LMM|||Week 1-52 Mean daily number of puffs||0.06|-0.25|0.245
70921810|NCT02554786|141333831|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.001|TWO_SIDED|95.0|0.39|0.72|||Regression, Cox|||Moderate or severe asthma exacerbation||0.72|0.39|<0.001
71095435|NCT01952678|141699002|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.3||||1|TWO_SIDED|95.0|-20.8|20.8|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.8|-20.8|1.0000
70974571|NCT03021642|141455848|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS mean ratio|96.88|||||TWO_SIDED|90.0|90.8|103.36||||||||103.36|90.8|
70974572|NCT03021642|141455849|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|0.0||||0.8981|TWO_SIDED|90.0|-1.0|1.025|||Wilcoxon signed-rank test|||||1.025|-1.000|0.8981
70974573|NCT00441545|141455863|SUPERIORITY_OR_OTHER_LEGACY|||||||0.113||95.0|||||ANCOVA|||||||0.1130
70974574|NCT00441545|141455864|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0249||95.0|||||ANCOVA|||||||0.0249
71095436|NCT01952678|141699003|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.0||||1|TWO_SIDED|95.0|-22.8|22.8|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||22.8|-22.8|1.0000
71095437|NCT01952678|141699003|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|5.2||||0.5187|TWO_SIDED|95.0|-16.7|26.2|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||26.2|-16.7|0.5187
70921811|NCT02554786|141333831|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|0.001|TWO_SIDED|95.0|0.34|0.6|||Regression, Cox|||Moderate or severe asthma exacerbation||0.6|0.34|<0.001
70921812|NCT02554786|141333831|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.209|TWO_SIDED|95.0|0.59|1.12|||Regression, Cox|||Moderate or severe asthma exacerbation||1.12|0.59|0.209
70921813|NCT02554786|141333831|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.003|TWO_SIDED|95.0|0.36|0.81|||Regression, Cox|||Severe asthma exacerbation||0.81|0.36|0.003
70921814|NCT02554786|141333831|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.001|TWO_SIDED|95.0|0.3|0.63|||Regression, Cox|||Severe asthma exacerbation||0.63|0.3|<0.001
70921815|NCT02554786|141333831|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.115|TWO_SIDED|95.0|0.47|1.09|||Regression, Cox|||Severe asthma exacerbation||1.09|0.47|0.115
70921816|NCT02554786|141333831|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.001|TWO_SIDED|95.0|0.51|0.82|||Regression, Cox|||All asthma exacerbation||0.82|0.51|<0.001
70921817|NCT02554786|141333831|SUPERIORITY||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|95.0|0.38|0.6|||Regression, Cox|||All asthma exacerbation||0.6|0.38|<0.001
70921818|NCT02554786|141333831|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.185|TWO_SIDED|95.0|0.66|1.08|||Regression, Cox|||All asthma exacerbation||1.08|0.66|0.185
70921819|NCT02554786|141333832|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.337|TWO_SIDED|95.0|0.13|2.03|||Regression, Cox|||||2.03|0.13|0.337
70921820|NCT02554786|141333832|SUPERIORITY||Hazard Ratio (HR)|0.14||||0.063|TWO_SIDED|95.0|0.02|1.11|||Regression, Cox|||||1.11|0.02|0.063
70921821|NCT02554786|141333832|SUPERIORITY||Hazard Ratio (HR)|1.62||||0.599|TWO_SIDED|95.0|0.27|9.7|||Regression, Cox|||||9.7|0.27|0.599
70921822|NCT02554786|141333833|SUPERIORITY||Rate Ratio|0.65||||0.008|TWO_SIDED|95.0|0.48|0.89|||Generalized linear model|||Moderate or severe asthma exacerbation||0.89|0.48|0.008
70921823|NCT02554786|141333833|SUPERIORITY||Rate Ratio|0.47|||<|0.001|TWO_SIDED|95.0|0.35|0.64|||Generalized linear model|||Moderate or severe asthma exacerbation||0.64|0.35|<0.001
70921824|NCT02554786|141333833|SUPERIORITY||Rate Ratio|0.93||||0.669|TWO_SIDED|95.0|0.67|1.29|||Generalized linear model|||Moderate or severe asthma exacerbation||1.29|0.67|0.669
70921825|NCT02554786|141333833|SUPERIORITY||Rate Ratio|0.71||||0.108|TWO_SIDED|95.0|0.47|1.08|||Generalized linear model|||Severe asthma exacerbation||1.08|0.47|0.108
70921826|NCT02554786|141333833|SUPERIORITY||Rate Ratio|0.46|||<|0.001|TWO_SIDED|95.0|0.31|0.67|||Generalized linear model|||Severe asthma exacerbation||0.67|0.31|<0.001
70921827|NCT02554786|141333833|SUPERIORITY||Rate Ratio|0.89||||0.597|TWO_SIDED|95.0|0.58|1.37|||Generalized linear model|||Severe asthma exacerbation||1.37|0.58|0.597
70921828|NCT02554786|141333833|SUPERIORITY||Rate Ratio|0.67||||0.002|TWO_SIDED|95.0|0.52|0.87|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||0.87|0.52|0.002
70921829|NCT02554786|141333833|SUPERIORITY||Rate Ratio|0.46|||<|0.001|TWO_SIDED|95.0|0.36|0.59|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||0.59|0.36|<0.001
70921830|NCT02554786|141333833|SUPERIORITY||Rate Ratio|0.95||||0.681|TWO_SIDED|95.0|0.72|1.23|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||1.23|0.72|0.681
70921831|NCT02554786|141333834|SUPERIORITY||||||<|0.001|||||||van Elteren test|||Moderate or severe asthma exacerbation||||<0.001
70921832|NCT02554786|141333834|SUPERIORITY||||||<|0.001|||||||van Elteren test|||Moderate or severe asthma exacerbation||||<0.001
70921833|NCT02554786|141333834|SUPERIORITY|||||||0.059|||||||van Elteren test|||Moderate or severe asthma exacerbation||||0.059
70921834|NCT02554786|141333834|SUPERIORITY|||||||0.004|||||||Van Elteren Test|||Severe Asthma Exacerbation||||0.004
70921835|NCT02554786|141333834|SUPERIORITY||||||<|0.001|||||||Van Elteren Test|||Severe Asthma Exacerbation||||<0.001
70921836|NCT02554786|141333834|SUPERIORITY|||||||0.025|||||||van Elteren test|||Severe asthma exacerbation||||0.025
70921837|NCT02554786|141333834|SUPERIORITY|||||||0.002|||||||Van Elteren Test|||All(mild, moderate, severe) Asthma Exacerbation||||0.002
70921838|NCT02554786|141333834|SUPERIORITY||||||<|0.001|||||||Van Elteren Test|||All (mild, moderate, severe) Asthma Exacerbation||||<0.001
70921839|NCT02554786|141333834|SUPERIORITY|||||||0.074|||||||van Elteren test|||All (mild, moderate, severe) asthma exacerbation||||0.074
70921840|NCT02554786|141333836|SUPERIORITY||Hazard Ratio (HR)|0.26||||0.222|TWO_SIDED|95.0|0.03|2.29|||Regression, Cox|||||2.29|0.03|0.222
71095438|NCT01952678|141699003|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.2||||1|TWO_SIDED|95.0|-21.5|21.5|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||21.5|-21.5|1.0000
71095439|NCT01952678|141699003|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|2.7||||0.7123|TWO_SIDED|95.0|-19.1|23.9|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||23.9|-19.1|0.7123
71154274|NCT04972162|141801174|OTHER|The rm-ANOVA model fitted for the primary analysis was run to confirm if there is a significant interaction for treatment and order. This confirmation of the absence of an interaction effect is needed to validate the pooling of the two periods of Web-App treatment and the two periods of Standard-of-Care treatment, respectively.||||||0.79||||||p\<0.05 would show that there is an interaction effect i.e. results would differ depending on the order in which the participants wore the hearing aids|ANOVA|||"Check for interaction effect for Background Noise Subscale (BN)~The statistical analysis method was a repeated-measures ANOVA in which:~* order is a between-subjects effect - i.e., each subject has just one order~* treatment is a within-subjects effect - i.e., each subjects has both treatments because of the cross-over design~* the interaction term treatment x order is a within-subjects effect. The rm-ANOVAs generates a nuisance p-value: that of the interaction effect."||||0.79
71154275|NCT04972162|141801174|OTHER|The rm-ANOVA model fitted for the primary analysis was run to confirm if there is a significant interaction for treatment and order. This confirmation of the absence of an interaction effect is needed to validate the pooling of the two periods of Web-App treatment and the two periods of Standard-of-Care treatment, respectively.||||||0.51||||||p\<0.05 would show that there is an interaction effect i.e. results would differ depending on the order in which the participants wore the hearing aids|ANOVA|||"Check for interaction effect for Reverberant Room Subscale (RV)~The statistical analysis method was a repeated-measures ANOVA in which:~* order is a between-subjects effect - i.e., each subject has just one order~* treatment is a within-subjects effect - i.e., each subjects has both treatments because of the cross-over design~* the interaction term treatment x order is a within-subjects effect. The rm-ANOVAs generates a nuisance p-value: that of the interaction effect."||||0.51
71154276|NCT04972162|141801174|NON_INFERIORITY|Non-inferiority tests compared the subject´s perceived hearing aid benefit when the hearing aid was standard-of-care fitted compared to Web-App fitted by the subject. The non-inferiority margins are the minimum clinically important differences on each of the 3 communication benefit subscales as described by Cox \& Alexander (Ear and Hearing 1995;16;176-186). These literature values are as follows: Ease of Communication (EC): 26, Background Noise (BN): 27, Reverberant Room (RV): 28|Mean Difference (Final Values)|0.44|||<|0.0001|TWO_SIDED|95.0|-4.3|5.2||Threshold for statistical significance was p =0.05. p-value was calculated using the estimated difference of benefits, calculating a new t-statistic by subtracting the applicable non-inf. margin from the difference and dividing by standard error.|ANOVA|repeated measures ANOVA where factors are order and treatment is device with patient as a random effect. Added interaction term of treatment and order|Difference calculated as benefit(standard-of-care fit) - benefit(web-app-fit)|Results for Ease of Communication Subscale. Null hypothesis: benefit(standard-of-care fit) - benefit(web-app-fit) \< noninferiority margin for all subscales. Each subscale was analyzed using an rm-ANOVA in which the repeated factors are order \& treatment; no between-group factors. Interaction term was order x treatment. ITT population includes 2 subjects who withdrew. It was concluded that their primary endpoint data was missing for cause and their APHAB benefit scores were imputed as 0.||5.2|-4.3|<0.0001
71154277|NCT04972162|141801174|NON_INFERIORITY|Non-inferiority tests compared the subject´s perceived hearing aid benefit when the hearing aid was standard-of-care fitted compared to Web-App fitted by the subject. The non-inferiority margins are the minimum clinically important differences on each of the 3 communication benefit subscales as described by Cox \& Alexander (Ear and Hearing 1995;16;176-186). These literature values are as follows: Ease of Communication (EC): 26, Background Noise (BN): 27, Reverberant Room (RV): 28|Mean Difference (Final Values)|0.97|||<|0.0001|TWO_SIDED|95.0|-5.3|7.2||Threshold for statistical significance was p =0.05. p-value was calculated using the estimated difference of benefits, calculating a new t-statistic by subtracting the applicable non-inf. margin from the difference and dividing by standard error.|ANOVA|repeated measures ANOVA where factors are order and treatment is device with patient as a random effect. Added interaction term of treatment and order|Difference calculated as benefit(standard-of-care fit) - benefit(web-app-fit)|Results for Background Noise Subscale. Null hypothesis: benefit(standard-of-care fit) - benefit(web-app-fit) \< noninferiority margin for all subscales. Each subscale was analyzed using an rm-ANOVA in which the repeated factors are order \& treatment; no between-group factors. Interaction term was order x treatment. ITT population includes 2 subjects who withdrew. It was concluded that their primary endpoint data was missing for cause and their APHAB benefit scores were imputed as 0.||7.2|-5.3|<0.0001
71095440|NCT01952678|141699004|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.0||||1|TWO_SIDED|95.0|-13.3|15.3|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||15.3|-13.3|1.0000
70974575|NCT02474082|141455867|SUPERIORITY||Odds Ratio (OR)|16.61|||<|0.0001|TWO_SIDED|95.0|7.79|35.4|||Regression, Logistic|||||35.40|7.79|<.0001
71095441|NCT01952678|141699004|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|-3.8||||0.5731|TWO_SIDED|95.0|-17.7|9.8|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||9.8|-17.7|0.5731
71095442|NCT01952678|141699004|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.1||||1|TWO_SIDED|95.0|-13.8|13.8|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||13.8|-13.8|1.0000
71095443|NCT01952678|141699004|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.1||||0.834|TWO_SIDED|95.0|-12.8|14.7|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||14.7|-12.8|0.8340
71095444|NCT01952678|141699005|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.0||||1|TWO_SIDED|95.0|-13.5|15.6|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||15.6|-13.5|1.0000
71095445|NCT01952678|141699005|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|-1.9||||0.8429|TWO_SIDED|95.0|-16.1|12.0|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||12.0|-16.1|0.8429
71095446|NCT01952678|141699005|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.1||||0.8214|TWO_SIDED|95.0|-13.0|15.0|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||15.0|-13.0|0.8214
70974576|NCT04317274|141455888|OTHER||Slope|-0.19||||0.21|TWO_SIDED||||||Mixed Models Analysis|Note: original plan was to conduct ANOVAs, but failed tests of assumptions||We tested for interaction effect of order and video version within the high cholesterol group.||||0.21
71033572|NCT00913627|141577224|SUPERIORITY_OR_OTHER||CMH adjusted proportions|5.39||||0.354|TWO_SIDED|95.0|-4.62|15.4||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||15 minutes||15.40|-4.62|0.354
71033573|NCT00913627|141577224|SUPERIORITY_OR_OTHER||CMH adjusted proportions|48.65|||<|0.001|TWO_SIDED|95.0|33.34|63.96||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes||63.96|33.34|<0.001
71095447|NCT01952678|141699005|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|2.2||||0.6577|TWO_SIDED|95.0|-12.0|16.1|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||16.1|-12.0|0.6577
70974577|NCT04317274|141455888|OTHER||Slope|-1.23|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Original plan was to conduct ANOVAs, but failed tests of assumptions||We tested for interaction effect of order and video version within the colorectal cancer group.||||<0.001
70974578|NCT04317274|141455889|OTHER||Slope|0.58|||<|0.001|TWO_SIDED||||||Pearson's correlation coefficient|||We examined the correlation between SDM Process and SDM-Q9 scores in the high cholesterol group.||||<.001
70974579|NCT04317274|141455889|OTHER||Slope|0.71|||<|0.001|TWO_SIDED||||||Pearson's correlation coefficient]|||We examined the correlation between SDM Process and SDM-Q9 scores in the colorectal cancer group.||||<.001
70974580|NCT01017952|141455902|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81||||0.04|TWO_SIDED|95.0|0.66|0.99|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||0.99|0.66|0.040
70974581|NCT01017952|141455902|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79||||0.024|TWO_SIDED|95.0|0.64|0.97|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||0.97|0.64|0.024
71033574|NCT00913627|141577224|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.94|||<|0.001|TWO_SIDED|95.0|37.15|66.73||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes||66.73|37.15|<0.001
71095448|NCT00421733|141699031|SUPERIORITY_OR_OTHER|||||||0.071||||||There were no P-value adjustments for multiple comparisons.|ANCOVA|1-way ANCOVA using treatment group as the factor and baseline FMV UACR as the covariate.||||||0.071
71095449|NCT00421733|141699031|SUPERIORITY_OR_OTHER|||||||0.229||95.0||||There were no P-value adjustments for multiple comparisons.|ANCOVA|1-way ANCOVA with treatment group as the factor and baseline FMV UACR as the covariate.||||||0.229
71095450|NCT00421733|141699031|SUPERIORITY_OR_OTHER|||||||0.053||95.0||||There were no P-value adjustments for multiple comparisons.|ANCOVA|1-way ANCOVA using treatment group as the factor and baseline FMV UACR as the covariate.||||||0.053
71095451|NCT00421733|141699032|SUPERIORITY_OR_OTHER|||||||0.102||95.0|||||Fisher Exact|||||||0.102
71095452|NCT00421733|141699032|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||Fisher Exact|||||||0.038
71095453|NCT00421733|141699033|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.855|TWO_SIDED|95.0|-0.26|0.22|||ANCOVA|2-way ANCOVA: baseline UACR as covariate; fixed factors for treatment group, stratification level, and treatment by stratification level interaction||||0.22|-0.26|0.855
71095454|NCT00421733|141699033|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.33||||0.009|TWO_SIDED|95.0|-0.57|-0.08|||ANCOVA|2-way ANCOVA: baseline UACR as covariate; fixed factors for treatment group, stratification level, and treatment by stratification level interaction||||-0.08|-0.57|0.009
71095455|NCT00421733|141699034|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|1-way ANCOVA with treatment group as the factor and baseline iPTH as covariate.||||||<0.001
71033575|NCT00913627|141577224|SUPERIORITY_OR_OTHER||CMH adjusted proportions|36.8|||<|0.001|TWO_SIDED|95.0|22.62|50.98||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes||50.98|22.62|<0.001
71033576|NCT00913627|141577224|SUPERIORITY_OR_OTHER||CMH adjusted proportions|57.39|||<|0.001|TWO_SIDED|95.0|41.2|73.57||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes||73.57|41.20|<0.001
71033577|NCT00913627|141577224|SUPERIORITY_OR_OTHER||CMH adjusted proportions|66.67|||<|0.001|TWO_SIDED|95.0|51.56|81.78||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes||81.78|51.56|<0.001
71033578|NCT00913627|141577224|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.2|||<|0.001|TWO_SIDED|95.0|34.2|66.21||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes||66.21|34.20|<0.001
71033579|NCT00913627|141577224|SUPERIORITY_OR_OTHER||CMH adjusted proportions|67.64|||<|0.001|TWO_SIDED|95.0|51.36|83.93||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes||83.93|51.36|<0.001
71033580|NCT00913627|141577224|SUPERIORITY_OR_OTHER||CMH adjusted proportions|70.61|||<|0.001|TWO_SIDED|95.0|55.16|86.05||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes||86.05|55.16|<0.001
71033581|NCT00913627|141577224|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.85|||<|0.001|TWO_SIDED|95.0|34.32|69.38||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes||69.38|34.32|<0.001
71095456|NCT00421733|141699034|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|1-way ANCOVA with treatment group as the factor and baseline iPTH as covariate.||||||<0.001
71095457|NCT02265744|141699035|SUPERIORITY|||||||0.9745|||||||Chi-squared|Nominal p-values that are not adjusted for multiplicity.||||||0.9745
71095458|NCT02265744|141699035|SUPERIORITY|||||||0.6217|||||||Chi-squared|Nominal p-values that are not adjusted for multiplicity.||||||0.6217
71095459|NCT02265744|141699035|SUPERIORITY|||||||0.8295|||||||Chi-squared|Nominal p-values that are not adjusted for multiplicity.||||||0.8295
71095460|NCT02265744|141699035|SUPERIORITY|||||||0.9439|||||||Chi-squared|Nominal p-values that are not adjusted for multiplicity.||||||0.9439
71033582|NCT00913627|141577224|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes||85.33|53.33|<0.001
71033583|NCT00913627|141577224|SUPERIORITY_OR_OTHER||CMH adjusted proportions|74.21|||<|0.001|TWO_SIDED|95.0|59.29|89.14||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes||89.14|59.29|<0.001
71033584|NCT00913627|141577224|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes||75.84|41.88|<0.001
71033585|NCT00913627|141577224|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes||85.33|53.33|<0.001
71033586|NCT00913627|141577224|SUPERIORITY_OR_OTHER||CMH adjusted proportions|77.82|||<|0.001|TWO_SIDED|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes||92.06|63.57|<0.001
71033587|NCT00913627|141577224|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes||75.84|41.88|<0.001
71033588|NCT00913627|141577224|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes||85.33|53.33|<0.001
71033589|NCT00913627|141577224|SUPERIORITY_OR_OTHER||CMH adjusted proportions|77.82|||<|0.001|TWO_SIDED|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes||92.06|63.57|<0.001
71033590|NCT00913627|141577224|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes||75.84|41.88|<0.001
71033591|NCT00913627|141577224|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes||85.33|53.33|<0.001
71033592|NCT00913627|141577224|SUPERIORITY_OR_OTHER||CMH adjusted proportions|77.82|||<|0.001|TWO_SIDED|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes||92.06|63.57|<0.001
71033593|NCT00913627|141577224|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes||75.84|41.88|<0.001
71033594|NCT00913627|141577224|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes||85.33|53.33|<0.001
71095461|NCT00299221|141699073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|0.4||0.44||95.0|||||t-test, 2 sided|||comparing ISHLT biopsy score between groups at 1 year||||0.44
71095462|NCT01086475|141699077|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||t-test, 2 sided|||||||0.45
71095463|NCT01086475|141699078|SUPERIORITY_OR_OTHER|||||||0.927|||||||Chi-squared|||||||0.927
71095464|NCT01086475|141699079|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||t-test, 2 sided|||||||0.048
71095465|NCT00505362|141699080|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
71095466|NCT00505362|141699081|SUPERIORITY_OR_OTHER|||||||0.61|||||||t-test, 2 sided|||||||0.61
71095467|NCT01004393|141699089|SUPERIORITY_OR_OTHER|||||||0.161|TWO_SIDED||||||ANOVA|||||||0.161
71095468|NCT04999020|141699095|SUPERIORITY||Difference in response rates|-15.38||||0.4192|TWO_SIDED|80.0|-38.55|8.48|||Barnard's unconditional exact test|||||8.48|-38.55|0.4192
71095469|NCT02448043|141699111|SUPERIORITY|||||||0.532||||||Threshold is p\<0.05|t-test, 2 sided|||||||0.532
71095470|NCT02448043|141699112|SUPERIORITY|||||||0.523||||||Threshold is p\<0.05|t-test, 2 sided|||||||0.523
71095471|NCT02448043|141699113|SUPERIORITY|||||||0.912||||||Threshold is p\<0.05|t-test, 2 sided|||Comparing baseline values of both arms to completion values of both arms||||0.912
71095472|NCT02448043|141699114|SUPERIORITY|||||||0.062||||||Threshold is p\<0.05|t-test, 2 sided|||Comparison between baseline nail brittleness values and completion values||||0.062
71095473|NCT01835756|141699152|SUPERIORITY_OR_OTHER||||||<|1e-05|TWO_SIDED||||||t-test, 2 sided|||||||<0.00001
71095474|NCT01835756|141699153|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71095475|NCT04465955|141699158|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.4345|TWO_SIDED|95.0|-0.528|0.227|||Random coefficient model|Covariates included terms for time, treatment-by-time interaction, baseline fellow eye CNV status, baseline focality, and baseline GA lesion location||Rate of Change Difference Between NGM621 Q4W and Pooled Sham||0.227|-0.528|0.4345
71095476|NCT04465955|141699158|SUPERIORITY||Mean Difference (Final Values)|-0.155||||0.4217|TWO_SIDED|95.0|-0.536|0.225|||Random coefficient model|Covariates included terms for time, treatment-by-time interaction, baseline fellow eye CNV status, baseline focality, and baseline GA lesion location||Rate of Change Difference Between NGM621 Q8W and Pooled Sham||0.225|-0.536|0.4217
70921841|NCT02554786|141333836|SUPERIORITY||Hazard Ratio (HR)|0.0||||0.992|TWO_SIDED|95.0|0.0||The upper limit of CI could not be calculated due to low number of participants with asthma exacerbation.||Regression, Cox||||||0|0.992
70921842|NCT02554786|141333836|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.618|TWO_SIDED|95.0|0.05|6.01|||Regression, Cox|||||6.01|0.05|0.618
70921843|NCT02554786|141333839|SUPERIORITY||LS Mean|10.1|STANDARD_ERROR_OF_MEAN|2.02|<|0.001|TWO_SIDED|95.0|6.2|14.1|||LMM|||Weeks 1-26||14.1|6.2|< 0.001
70921844|NCT02554786|141333839|SUPERIORITY||LS Mean|8.3|STANDARD_ERROR_OF_MEAN|2.02|<|0.001|TWO_SIDED|95.0|4.3|12.3|||LMM|||Weeks 1-26||12.3|4.3|<0.001
70921845|NCT02554786|141333839|SUPERIORITY||LS Mean|4.1|STANDARD_ERROR_OF_MEAN|2.02||0.045|TWO_SIDED|95.0|0.1|8.0|||LMM|||Weeks 1-26||8|0.1|0.045
70921846|NCT02554786|141333839|SUPERIORITY||LS Mean|9.6|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|5.7|13.6|||LMM|||Weeks 1-52||13.6|5.7|<0.001
70921847|NCT02554786|141333839|SUPERIORITY||LS Mean|8.6|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|4.7|12.6|||LMM|||Weeks 1-52||12.6|4.7|<0.001
70921848|NCT02554786|141333839|SUPERIORITY||LS Mean|4.3|STANDARD_ERROR_OF_MEAN|2.04||0.034|TWO_SIDED|95.0|0.3|8.3|||LMM|||Weeks 1-52||8.3|0.3|0.034
70921849|NCT02554786|141333840|SUPERIORITY||LS Mean|0.147|STANDARD_ERROR_OF_MEAN|0.0462||0.002|TWO_SIDED|95.0|0.056|0.237|||MMRM|||Day 30||0.237|0.056|0.002
70921850|NCT02554786|141333840|SUPERIORITY||LS Mean|0.123|STANDARD_ERROR_OF_MEAN|0.0464||0.008|TWO_SIDED|95.0|0.032|0.214|||MMRM|||Day 30||0.214|0.032|0.008
70921851|NCT02554786|141333840|SUPERIORITY||LS Mean|0.045|STANDARD_ERROR_OF_MEAN|0.046||0.33|TWO_SIDED|95.0|-0.045|0.135|||MMRM|||Day 30||0.135|-0.045|0.33
70921852|NCT02554786|141333840|SUPERIORITY||LS Mean|0.054|STANDARD_ERROR_OF_MEAN|0.0503||0.28|TWO_SIDED|95.0|-0.044|0.153|||MMRM|||Day 86||0.153|-0.044|0.28
70921853|NCT02554786|141333840|SUPERIORITY||LS Mean|0.118|STANDARD_ERROR_OF_MEAN|0.0507||0.02|TWO_SIDED|95.0|0.019|0.217|||MMRM|||Day 86||0.217|0.019|0.02
70921854|NCT02554786|141333840|SUPERIORITY||LS Mean|0.026|STANDARD_ERROR_OF_MEAN|0.0501||0.598|TWO_SIDED|95.0|-0.072|0.125|||MMRM|||Day 86||0.125|-0.072|0.598
70974582|NCT01017952|141455902|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.69|||<|0.001|TWO_SIDED|95.0|0.56|0.85|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||0.85|0.56|<0.001
70921855|NCT02554786|141333840|SUPERIORITY||LS Mean|0.127|STANDARD_ERROR_OF_MEAN|0.0526||0.016|TWO_SIDED|95.0|0.023|0.23|||MMRM|||Day 183||0.23|0.023|0.016
70921856|NCT02554786|141333840|SUPERIORITY||LS Mean|0.156|STANDARD_ERROR_OF_MEAN|0.0529||0.003|TWO_SIDED|95.0|0.053|0.26|||MMRM|||Day 183||0.26|0.053|0.003
70921857|NCT02554786|141333840|SUPERIORITY||LS Mean|0.085|STANDARD_ERROR_OF_MEAN|0.0525||0.103|TWO_SIDED|95.0|-0.017|0.188|||MMRM|||Day 183||0.188|-0.017|0.103
70921858|NCT02554786|141333840|SUPERIORITY||LS Mean|0.071|STANDARD_ERROR_OF_MEAN|0.0542||0.188|TWO_SIDED|95.0|-0.035|0.178|||MMRM|||Day 254||0.178|-0.035|0.188
70921859|NCT02554786|141333840|SUPERIORITY||LS Mean|0.168|STANDARD_ERROR_OF_MEAN|0.0543||0.002|TWO_SIDED|95.0|0.061|0.274|||MMRM|||Day 254||0.274|0.061|0.002
70921860|NCT02554786|141333840|SUPERIORITY||LS Mean|0.061|STANDARD_ERROR_OF_MEAN|0.0538||0.258|TWO_SIDED|95.0|-0.045|0.166|||MMRM|||Day 254||0.166|-0.045|0.258
70921861|NCT02554786|141333840|SUPERIORITY||LS Mean|0.079|STANDARD_ERROR_OF_MEAN|0.0552||0.154|TWO_SIDED|95.0|-0.03|0.187|||MMRM|||Day 364||0.187|-0.030|0.154
70921862|NCT02554786|141333840|SUPERIORITY||LS Mean|0.191|STANDARD_ERROR_OF_MEAN|0.0553|<|0.001|TWO_SIDED|95.0|0.082|0.299|||MMRM|||Day 364||0.299|0.082|<0.001
70921863|NCT02554786|141333840|SUPERIORITY||LS Mean|0.041|STANDARD_ERROR_OF_MEAN|0.0548||0.455|TWO_SIDED|95.0|-0.067|0.148|||MMRM|||Day 364||0.148|-0.067|0.455
70921864|NCT02554786|141333841|NON_INFERIORITY|QMF 150/320 was considered non-inferior to S/F 50/500 if the lower bound of the 95% CI was above the non-inferiority margin of -90 mL and was considered superior if the lower bound of the 95% CI was \> 0. The p-value is for null-hypothesis testing.|LS Mean|0.036|STANDARD_ERROR_OF_MEAN|0.0222||0.101|TWO_SIDED|95.0|-0.007|0.08|||MMRM|||||0.080|-0.007|0.101
70921865|NCT05052996|141333847|OTHER||Difference in percentage|1.9|||||TWO_SIDED|95.0|-6.8|11.6|||||The difference in percentages between treatment groups and their 95% CI were calculated based on unconditional exact method using 2 inverted 1-sided tests.|||11.6|-6.8|
70921866|NCT05052996|141333848|OTHER||Difference in percentage|-1.9|||||TWO_SIDED|95.0|-12.4|8.6|||||The difference in percentages between treatment groups and their 95% CI were calculated based on unconditional exact method using 2 inverted 1-sided tests.|||8.6|-12.4|
70921867|NCT05052996|141333849|OTHER||Difference in percentage|1.9|||||TWO_SIDED|95.0|-8.6|12.4|||||The difference in percentages between treatment groups and their 95% CI were calculated based on unconditional exact method using 2 inverted 1-sided tests.|||12.4|-8.6|
70921868|NCT05052996|141333850|OTHER||difference in least squares means|-68.0||||0.3859|TWO_SIDED|95.0|-226.0|91.0|||ANOVA||P-value, difference in least squares means (Diff in LSM), and its 95% confidence interval (CI) were from ANOVA model with treatment group as a fixed effect in the model.|||91|-226|0.3859
70974583|NCT01017952|141455903|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.177|TWO_SIDED|95.0|0.71|1.06|||Regression, Cox|||||1.06|0.71|0.177
70974584|NCT01017952|141455903|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.036|TWO_SIDED|95.0|0.66|0.99|||Regression, Cox|||||0.99|0.66|0.036
70974585|NCT01017952|141455903|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66|||<|0.001|TWO_SIDED|95.0|0.54|0.82|||Regression, Cox|||||0.82|0.54|<0.001
70974586|NCT01017952|141455904|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84||||0.154|TWO_SIDED|95.0|0.65|1.07|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||1.07|0.65|0.154
70921869|NCT05052996|141333850|OTHER||difference in least squares means|13.0||||0.7085|TWO_SIDED|95.0|-56.0|82.0|||ANCOVA||P-value, difference in least squares means (Diff in LSM), and its 95% CI were from ANCOVA model with baseline value as a covariate and treatment as a fixed effect in the model.|||82|-56|0.7085
71033595|NCT00913627|141577224|SUPERIORITY_OR_OTHER||CMH adjusted proportions|77.82|||<|0.001|TWO_SIDED|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes||92.06|63.57|<0.001
71033596|NCT00913627|141577224|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes||75.84|41.88|<0.001
71033597|NCT00913627|141577224|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes||85.33|53.33|<0.001
71033598|NCT00913627|141577224|SUPERIORITY_OR_OTHER||CMH adjusted proportions|77.82|||<|0.001|TWO_SIDED|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes||92.06|63.57|<0.001
71033599|NCT00913627|141577224|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes||75.84|41.88|<0.001
71033600|NCT00913627|141577225|SUPERIORITY_OR_OTHER||Hazard Ratio, log|13.56|||<|0.001|TWO_SIDED|95.0|4.85|37.89||p-value adjusted for gender and categorical baseline pain severity|Proportional hazards regression|||||37.89|4.85|<0.001
71033601|NCT00913627|141577226|SUPERIORITY_OR_OTHER||CMH adjusted proportions|2.03||||0.434|TWO_SIDED|95.0|-1.95|6.02||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||15 minutes||6.02|-1.95|0.434
71033602|NCT00913627|141577226|SUPERIORITY_OR_OTHER||CMH adjusted proportions|0.0|||||TWO_SIDED|95.0|0.0|0.0|||Cochran-Mantel-Haenszel|||15 minutes||0.00|0.00|
71033603|NCT00913627|141577226|SUPERIORITY_OR_OTHER||CMH adjusted proportions|1.78||||0.469|TWO_SIDED|95.0|-1.71|5.27||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||15 minutes||5.27|-1.71|0.469
71033604|NCT00913627|141577226|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.13||||0.101|TWO_SIDED|95.0|1.33|16.93||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes||16.93|1.33|0.101
71033605|NCT00913627|141577226|SUPERIORITY_OR_OTHER||CMH adjusted proportions|10.73||||0.069|TWO_SIDED|95.0|2.54|18.91||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes||18.91|2.54|0.069
71095477|NCT03501277|141699232|EQUIVALENCE|Alogliptin: For each analyte, an analysis of variance (ANOVA) was performed on natural logarithm transformed Cmax with factors for sequence, the participant nested within sequence, period, and regimen. For the relative bioavailability (BA) determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90 percent (%) confidence interval (CI) for the ratio of Cmax for Regimen A (test) versus Regimen B (reference).|Least Square Mean (LSM) difference|1.0706||||0.014|TWO_SIDED|90.0|1.023|1.1204|||ANOVA|||||1.1204|1.0230|0.014
71033606|NCT00913627|141577226|SUPERIORITY_OR_OTHER||CMH adjusted proportions|3.59||||0.303|TWO_SIDED|95.0|-1.39|8.57||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes||8.57|-1.39|0.303
71033607|NCT00913627|141577226|SUPERIORITY_OR_OTHER||CMH adjusted proportions|24.58||||0.008|TWO_SIDED|95.0|10.68|38.47||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes||38.47|10.68|0.008
71033608|NCT00913627|141577226|SUPERIORITY_OR_OTHER||CMH adjusted proportions|25.31||||0.007|TWO_SIDED|95.0|11.35|39.28||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes||39.28|11.35|0.007
71033609|NCT00913627|141577226|SUPERIORITY_OR_OTHER||CMH adjusted proportions|10.62||||0.129|TWO_SIDED|95.0|-0.68|21.92||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes||21.92|-0.68|0.129
71033610|NCT00913627|141577226|SUPERIORITY_OR_OTHER||CMH adjusted proportions|47.72|||<|0.001|TWO_SIDED|95.0|32.25|63.19||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes||63.19|32.25|<0.001
71033611|NCT00913627|141577226|SUPERIORITY_OR_OTHER||CMH adjusted proportions|36.01|||<|0.001|TWO_SIDED|95.0|21.24|50.78||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes||50.78|21.24|<0.001
71033612|NCT00913627|141577226|SUPERIORITY_OR_OTHER||CMH adjusted proportions|27.87||||0.003|TWO_SIDED|95.0|13.93|41.81||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes||41.81|13.93|0.003
71033613|NCT00913627|141577226|SUPERIORITY_OR_OTHER||CMH adjusted proportions|61.01|||<|0.001|TWO_SIDED|95.0|46.12|75.89||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes||75.89|46.12|<0.001
71033614|NCT00913627|141577226|SUPERIORITY_OR_OTHER||CMH adjusted proportions|53.83|||<|0.001|TWO_SIDED|95.0|38.85|68.8||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes||68.80|38.85|<0.001
71033615|NCT00913627|141577226|SUPERIORITY_OR_OTHER||CMH adjusted proportions|46.74|||<|0.001|TWO_SIDED|95.0|31.89|61.58||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes||61.58|31.89|<0.001
71033616|NCT00913627|141577226|SUPERIORITY_OR_OTHER||CMH adjusted proportions|64.78|||<|0.001|TWO_SIDED|95.0|49.37|80.18||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes||80.18|49.37|<0.001
71033617|NCT00913627|141577226|SUPERIORITY_OR_OTHER||CMH adjusted proportions|64.8|||<|0.001|TWO_SIDED|95.0|50.01|79.59||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes||79.59|50.01|<0.001
71033618|NCT00913627|141577226|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.19|||<|0.001|TWO_SIDED|95.0|34.27|66.11||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes||66.11|34.27|<0.001
71033619|NCT00913627|141577226|SUPERIORITY_OR_OTHER||CMH adjusted proportions|68.59|||<|0.001|TWO_SIDED|95.0|52.81|84.38||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes||84.38|52.81|<0.001
71033620|NCT00913627|141577226|SUPERIORITY_OR_OTHER||CMH adjusted proportions|72.16|||<|0.001|TWO_SIDED|95.0|57.05|87.26||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes||87.26|57.05|<0.001
71033621|NCT00913627|141577226|SUPERIORITY_OR_OTHER||CMH adjusted proportions|53.47|||<|0.001|TWO_SIDED|95.0|36.57|70.37||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes||70.37|36.57|<0.001
71033622|NCT00913627|141577226|SUPERIORITY_OR_OTHER||CMH adjusted proportions|72.66|||<|0.001|TWO_SIDED|95.0|57.48|87.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes||87.84|57.48|<0.001
71033623|NCT00913627|141577226|SUPERIORITY_OR_OTHER||CMH adjusted proportions|79.36|||<|0.001|TWO_SIDED|95.0|65.68|93.05||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes||93.05|65.68|<0.001
71033624|NCT00913627|141577226|SUPERIORITY_OR_OTHER||CMH adjusted proportions|57.03|||<|0.001|TWO_SIDED|95.0|40.46|73.6||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes||73.60|40.46|<0.001
71033625|NCT00913627|141577226|SUPERIORITY_OR_OTHER||CMH adjusted proportions|72.66|||<|0.001|TWO_SIDED|95.0|57.48|87.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes||87.84|57.48|<0.001
71033626|NCT00913627|141577226|SUPERIORITY_OR_OTHER||CMH adjusted proportions|81.2|||<|0.001|TWO_SIDED|95.0|67.91|94.49||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes||94.49|67.91|<0.001
71033627|NCT00913627|141577226|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.84|||<|0.001|TWO_SIDED|95.0|42.34|75.35||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes||75.35|42.34|<0.001
71033628|NCT00913627|141577226|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes||85.33|53.33|<0.001
71095478|NCT03501277|141699232|EQUIVALENCE|Alogliptin: For each analyte, ANOVA was performed on natural logarithm transformed Cmax with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of Cmax for Regimen C (test) versus Regimen D (reference).|LSM difference|1.0276||||0.326|TWO_SIDED|90.0|0.9817|1.0757|||ANOVA|||||1.0757|0.9817|0.326
71095479|NCT03501277|141699232|EQUIVALENCE|Pioglitazone: For each analyte, ANOVA was performed on natural logarithm transformed Cmax with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of Cmax for Regimen A (test) versus Regimen B (reference).|LSM diiference|0.9594||||0.405|TWO_SIDED|90.0|0.8837|1.0415|||ANOVA|||||1.0415|0.8837|0.405
71095480|NCT03501277|141699232|EQUIVALENCE|Pioglitazone: For each analyte, ANOVA was performed on natural logarithm transformed Cmax with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of Cmax for Regimen C (test) versus Regimen D (reference).|LSM difference|0.9257||||0.124|TWO_SIDED|90.0|0.8523|1.0053|||ANOVA|||||1.0053|0.8523|0.124
71095481|NCT03501277|141699233|EQUIVALENCE|Alogliptin: For each analyte, ANOVA was performed on natural logarithm transformed AUC(0-72) with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of Cmax for Regimen A (test) versus Regimen B (reference).|LSM difference|1.0157||||0.081|TWO_SIDED|90.0|1.0009|1.0308|||ANOVA|||||1.0308|1.0009|0.081
71095482|NCT03501277|141699233|EQUIVALENCE|Alogliptin: For each analyte, ANOVA was performed on natural logarithm transformed AUC(0-72) with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of AUC(0-72) for Regimen C (test) versus Regimen D (reference).|LSM difference|1.0009||||0.922|TWO_SIDED|90.0|0.9862|1.0158|||ANOVA|||||1.0158|0.9862|0.922
71033629|NCT00913627|141577226|SUPERIORITY_OR_OTHER||CMH adjusted proportions|77.82|||<|0.001|TWO_SIDED|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes||92.06|63.57|<0.001
71033630|NCT00913627|141577226|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes||75.84|41.88|<0.001
71033631|NCT00913627|141577227|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma Statistic|0.93|||<|0.001|TWO_SIDED|95.0|0.85|1.01||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||||1.01|0.85|<0.001
71033632|NCT00913627|141577227|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma Statistic|0.95|||<|0.001|TWO_SIDED|95.0|0.88|1.02||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||||1.02|0.88|<0.001
71033633|NCT00913627|141577227|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma Statistic|0.84|||<|0.001|TWO_SIDED|95.0|0.7|0.98||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||||0.98|0.70|<0.001
71033634|NCT00913627|141577228|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma Statistic|0.93|||<|0.001|TWO_SIDED|95.0|0.85|1.01||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||||1.01|0.85|<0.001
71033635|NCT00913627|141577228|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma Statistic|0.96|||<|0.001|TWO_SIDED|95.0|0.91|1.01||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||||1.01|0.91|<0.001
71033636|NCT00913627|141577228|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma Statistic|0.89|||<|0.001|TWO_SIDED|95.0|0.79|0.99||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||||0.99|0.79|<0.001
71033637|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.008|TWO_SIDED|95.0|0.06|0.38||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.38|0.06|0.008
71033638|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.007|TWO_SIDED|95.0|0.06|0.38||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.38|0.06|0.007
71033639|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.024|TWO_SIDED|95.0|0.02|0.34||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.34|0.02|0.024
71095483|NCT03501277|141699233|EQUIVALENCE|Pioglitazone: For each analyte, ANOVA was performed on natural logarithm transformed AUC(0-72) with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of AUC(0-72) for Regimen A (test) versus Regimen B (reference).|LSM difference|1.0486||||0.066|TWO_SIDED|90.0|1.0051|1.0939|||ANOVA|||||1.0939|1.0051|0.066
71033640|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.51|||<|0.001|TWO_SIDED|95.0|0.24|0.78||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||0.78|0.24|<0.001
71033641|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47|||<|0.001|TWO_SIDED|95.0|0.2|0.73||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||0.73|0.20|<0.001
71033642|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.002|TWO_SIDED|95.0|0.16|0.68||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||0.68|0.16|0.002
71033643|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85|||<|0.001|TWO_SIDED|95.0|0.52|1.17||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||1.17|0.52|<0.001
71095484|NCT03501277|141699233|EQUIVALENCE|Pioglitazone: For each analyte, ANOVA was performed on natural logarithm transformed AUC(0-72) with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of AUC(0-72) for Regimen C (test) versus Regimen D (reference).|LSM difference|1.0267||||0.308|TWO_SIDED|90.0|0.9839|1.0714|||ANOVA|||||1.0714|0.9839|0.308
71033644|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79|||<|0.001|TWO_SIDED|95.0|0.47|1.11||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||1.11|0.47|<0.001
71033645|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62|||<|0.001|TWO_SIDED|95.0|0.3|0.94||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||0.94|0.30|<0.001
71095485|NCT01327703|141699234|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval (CI) of Panzytrat® versus Kreon® exceeded -10%.|Treatment difference|-2.08||||0.459|TWO_SIDED|95.0|-7.23|4.02||As there was only a single pre-specified primary analysis, there was no adjustment for multiplicity.|Mixed Models Analysis|||Mixed model analysis method was used for comparison using log-transformed percent CFA as the response variable, fixed effect factors for treatment, period, treatment sequence and pooled site and participant within treatment sequence as a random effect.||4.02|-7.23|0.4590
71095486|NCT00849472|141699276|SUPERIORITY_OR_OTHER||Percentage of participants|17.98|||||TWO_SIDED|95.0|10.64|27.55|||||The estimated value (EV) represents the percentage of participants with pCR. Participants with missing data were excluded from the denominator (n=89; 4 participants with missing data) for the calculation of the EV.|||27.55|10.64|
70921870|NCT05052996|141333851|OTHER||difference in least squares means|33.0||||0.3477|TWO_SIDED|95.0|-37.0|103.0|||ANCOVA||P-value, difference in least squares means (Diff in LSM), and its 95% CI were from ANCOVA model with baseline value as a covariate and treatment as a fixed effect in the model.|||103|-37|0.3477
71033646|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01|||<|0.001|TWO_SIDED|95.0|0.65|1.37||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||1.37|0.65|<0.001
71095487|NCT00963508|141699296|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71033647|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.09|||<|0.001|TWO_SIDED|95.0|0.73|1.44||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||1.44|0.73|<0.001
71095488|NCT00963508|141699297|SUPERIORITY_OR_OTHER|||||||0.0005|||||||t-test, 2 sided|||||||0.0005
71033648|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|||<|0.001|TWO_SIDED|95.0|0.54|1.25||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||1.25|0.54|<0.001
71033649|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|||<|0.001|TWO_SIDED|95.0|0.9|1.63||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||1.63|0.90|<0.001
71033650|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.33|||<|0.001|TWO_SIDED|95.0|0.97|1.69||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||1.69|0.97|<0.001
71033651|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|||<|0.001|TWO_SIDED|95.0|0.74|1.45||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||1.45|0.74|<0.001
71033652|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.45|||<|0.001|TWO_SIDED|95.0|1.09|1.82||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||1.82|1.09|<0.001
71033653|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46|||<|0.001|TWO_SIDED|95.0|1.1|1.82||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||1.82|1.10|<0.001
71033654|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03|||<|0.001|TWO_SIDED|95.0|0.67|1.38||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||1.38|0.67|<0.001
71033655|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63|||<|0.001|TWO_SIDED|95.0|1.26|2.0||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||2.00|1.26|<0.001
71033656|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.61|||<|0.001|TWO_SIDED|95.0|1.25|1.98||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||1.98|1.25|<0.001
71033657|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21|||<|0.001|TWO_SIDED|95.0|0.85|1.57||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||1.57|0.85|<0.001
71033658|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.71|||<|0.001|TWO_SIDED|95.0|1.33|2.08||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||2.08|1.33|<0.001
71095489|NCT01181479|141699299|EQUIVALENCE|Comparison of AG200-15 and Lessina for cycles 1-6.||||||0.067|||||||Chi-squared|||||||0.067
71095490|NCT00433290|141699342|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Week 4 Change from Baseline. Treatment effects and interaction effects were evaluated based on two-sided significance level of 0.05. No adjustments for multiple comparisons were made.|Mixed Models Analysis|Repeated Measures Model: Change=Treatment,NSAID use, Pooled Investigator, Visit, Baseline, Treatment\*Visit, Baseline\*Visit||Null hypothesis=the difference in the BPI average pain score between the duloxetine and placebo treatment goups at the last visit of the treatment phase is zero.||||<0.001
71095491|NCT00433290|141699342|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Week 7 Change from Baseline. Treatment effects and interaction effects were evaluated based on two-sided significance level of 0.05. No adjustments for multiple comparisons were made.|Mixed Models Analysis|Repeated Measures Model: Change=Treatment,NSAID use, Pooled Investigator, Visit, Baseline, Treatment\*Visit, Baseline\*Visit||Null hypothesis=the difference in the BPI average pain score between the duloxetine and placebo treatment goups at the last visit of the treatment phase is zero.||||<0.001
70921871|NCT05052996|141333852|OTHER||difference in least squares means|-5.0||||0.8849|TWO_SIDED|95.0|-76.0|66.0|||ANCOVA||P-value, difference in least squares means (Diff in LSM), and its 95% CI were from ANCOVA model with baseline value as a covariate and treatment as a fixed effect in the model.|||66|-76|0.8849
70921872|NCT00522951|141333864|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin = -1|Mean Difference (Final Values)|-0.58||||||95.0|-0.87|-0.29|||||Averaged blinded reader (primary analysis)|H01: μG1 - μPr ≤ -1||-0.29|-0.87|
70921873|NCT00522951|141333864|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin = -1|Mean Difference (Final Values)|0.06||||||95.0|-0.23|0.36|||||Averaged blinded reader (primary analysis)|H02: μG2 - μPr ≤ -1||0.36|-0.23|
70921874|NCT00522951|141333864|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin = -1|Mean Difference (Final Values)|-0.3||||||95.0|-0.5|-0.1|||||Investigator (secondary analysis)|H01: μG1 - μPr ≤ -1||-0.1|-0.5|
70921875|NCT00522951|141333864|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin = -1|Mean Difference (Final Values)|0.21||||||95.0|0.02|0.41|||||Investigator (secondary analysis)|H02: μG2 - μPr ≤ -1||0.41|0.02|
70921876|NCT02794480|141333880|SUPERIORITY||||||<|0.001||||||ELLIPTA versus GSK MDI|Mainland-Gart test||||Mainland-Gart test is favorable over the McNemar test for matched pairs as the latter is only valid in case of no period effects.|||<0.001
70921877|NCT02794480|141333880|SUPERIORITY|||||||0.007||||||ELLIPTA versus AZ MDI|Mainland-Gart test||||Mainland-Gart test is favorable over the McNemar test for matched pairs as the latter is only valid in case of no period effects.|||0.007
70921878|NCT02794480|141333885|SUPERIORITY||Odds Ratio (OR)|5.94|||<|0.001|TWO_SIDED|95.0|2.42||The upper limit is infinity.|Exact odds ratio calculated using exact conditional logistic regression adjusted for treatment and treatment period.|Conditional Logistic Regression||ELLIPTA versus GSK MDI||||2.42|<0.001
70974587|NCT01017952|141455904|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77||||0.041|TWO_SIDED|95.0|0.6|0.99|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable||||0.99|0.60|0.041
70921879|NCT02794480|141333885|SUPERIORITY||Odds Ratio (OR)|4.16||||0.011|TWO_SIDED|95.0|1.59||The upper limit is infinity.|Exact odds ratio calculated using exact conditional logistic regression adjusted for treatment and treatment period.|Conditional Logistic Regression||ELLIPTA versus AZ MDI||||1.59|0.011
70921880|NCT01017146|141333886|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for ILs|ANCOVA|||||||<0.001
70921881|NCT01017146|141333886|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for NILs|ANCOVA|||||||<0.001
70921882|NCT01017146|141333886|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for TLs|ANCOVA|||||||<0.001
70921883|NCT01017146|141333887|SUPERIORITY_OR_OTHER||Percentage of participants|35.6|||<|0.001|TWO_SIDED|95.0|30.7|40.5|||Cochran-Mantel-Haenszel||The estimated value represents the percentage of participants receiving tazarotene foam with a minimum 2 G improvement in the ISGA score from Baseline at Week 12.|||40.5|30.7|<0.001
70921884|NCT01017146|141333887|SUPERIORITY_OR_OTHER||Percentage of participants|23.9|||||TWO_SIDED|95.0|19.6|28.3|||||The estimated value represents the percentage of participants receiving vehicle foam with a minimum 2 G improvement in the ISGA score from Baseline at Week 12.|||28.3|19.6|
70921885|NCT01017146|141333888|SUPERIORITY_OR_OTHER||Percentage of participants|28.8|||<|0.001|TWO_SIDED|95.0|24.2|33.5|||Cochran-Mantel-Haenszel||The estimated value represents the percentage of participants receiving tazarotene foam with an ISGA score of 0 or 1 at Week 12.|||33.5|24.2|<0.001
70921886|NCT01017146|141333888|SUPERIORITY_OR_OTHER||Percentage of participants|16.1|||||TWO_SIDED|95.0|12.4|19.9|||||The estimated value represents the percentage of participants receiving vehicle foam with an ISGA score of 0 or 1 at Week 12.|||19.9|12.4|
70921887|NCT00976495|141333908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.07|STANDARD_ERROR_OF_MEAN|2.7177|||TWO_SIDED|95.0|-13.34|-2.49|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||-2.49|-13.34|
70921888|NCT00976495|141333908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.62|STANDARD_ERROR_OF_MEAN|2.7068|||TWO_SIDED|95.0|-12.87|-2.06|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||-2.06|-12.87|
70974588|NCT01017952|141455904|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.65|||<|0.001|TWO_SIDED|95.0|0.51|0.84|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable||||0.84|0.51|<0.001
70974589|NCT01017952|141455905|SUPERIORITY_OR_OTHER||Least squares mean difference|0.034||||0.034|TWO_SIDED|95.0|0.003|0.066||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.066|0.003|0.034
70974590|NCT01017952|141455905|SUPERIORITY_OR_OTHER||Least squares mean difference|0.024||||0.143|TWO_SIDED|95.0|-0.008|0.056|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.056|-0.008|0.143
70974591|NCT01017952|141455905|SUPERIORITY_OR_OTHER||Least squares mean difference|0.026||||0.115|TWO_SIDED|95.0|-0.006|0.057|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.057|-0.006|0.115
70974592|NCT01064167|141455906|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|||Given that the frequency of RBC transfusion for OPCAB surgery is about 55%, to detect 35% reduction in TA group, with power=o.8 and α=0.05, a group of 107 patients in each arm is required. We estimated a crossover rate of 20%. The final sample size for randomization purposes increased to a total of 260 patients. The Chi-square test was used to test the differences in categorical variables between both groups.If one or more cells had an expected count less than 5, Fisher's Exact Test was used.||||<0.05
70974593|NCT01064167|141455907|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
70974594|NCT02642094|141455955|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||0.0020
70974595|NCT02642094|141455956|SUPERIORITY|||||||0.0137|||||||t-test, 2 sided|||||||0.0137
70974596|NCT02642094|141455957|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70974597|NCT02642094|141455958|SUPERIORITY|||||||0.0072|||||||t-test, 2 sided|||||||0.0072
70974598|NCT02642094|141455959|SUPERIORITY|||||||0.3093|||||||t-test, 2 sided|||||||0.3093
70974599|NCT02175680|141455973|SUPERIORITY||||||<|0.0001|||||||Wilcoxon Rank Sum|The time to Virologic Failure for the subjects treated with PRO 140 monotherapy was compared to historical data.|||The median time to Virologic Failure for historical controls was 29 days.|||<0.0001
70974600|NCT03979274|141455996|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric mean ratio|98.53|||||TWO_SIDED|90.0|94.55|102.68||||||||102.68|94.55|
70974601|NCT03979274|141455997|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric mean ratio|97.59|||||TWO_SIDED|90.0|91.34|104.26||||||||104.26|91.34|
70974602|NCT03979274|141456000|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric mean ratio|99.73|||||TWO_SIDED|90.0|98.45|101.03||||||||101.03|98.45|
70974603|NCT03979274|141456001|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric mean ratio|99.26|||||TWO_SIDED|90.0|97.7|100.85||||||||100.85|97.70|
70974604|NCT01665144|141456007|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.0134|TWO_SIDED|95.0|0.65|0.95|||Cox proportional hazards model|||||0.95|0.65|0.0134
70974605|NCT01665144|141456008|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.4398|TWO_SIDED|95.0|0.8|1.1|||Cox proportional hazards model|||||1.10|0.80|0.4398
70974606|NCT01665144|141456009|SUPERIORITY||Mean Difference (Final Values)|-613.1|STANDARD_ERROR_OF_MEAN|95.39|<|0.0001|TWO_SIDED|95.0|-800.2|-426.0|||Mixed model for repeated measures|||Month 12||-426.0|-800.2|<0.0001
70974607|NCT01665144|141456009|SUPERIORITY||Mean Difference (Final Values)|-777.5|STANDARD_ERROR_OF_MEAN|108.62|<|0.0001|TWO_SIDED|95.0|-990.6|-564.4|||Mixed model for repeated measures|||Month 24||-564.4|-990.6|<0.0001
70974608|NCT01665144|141456009|SUPERIORITY||Mean Difference (Final Values)|-695.3|STANDARD_ERROR_OF_MEAN|92.79|<|0.0001|TWO_SIDED|95.0|-877.3|-513.3|||Mixed model for repeated measures|||Average over Month 12 and Month 24||-513.3|-877.3|<0.0001
70974609|NCT01665144|141456010|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0058|TWO_SIDED|95.0|0.6|0.92|||Cox proportional hazards model|||||0.92|0.60|0.0058
70974610|NCT01665144|141456011|SUPERIORITY||ARR ratio|0.445|||<|0.0001|TWO_SIDED|95.0|0.337|0.587|||Negative binomial regression model|||||0.587|0.337|<0.0001
70974611|NCT01665144|141456012|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.41|0.7|||Cox proportional hazards model|||||0.70|0.41|<0.0001
70974612|NCT01665144|141456014|SUPERIORITY||Mean Difference (Final Values)|-1.83|STANDARD_ERROR_OF_MEAN|1.03||0.0764|TWO_SIDED|95.0|-3.85|0.19|||Repeated measures model|||Month 12||0.19|-3.85|0.0764
70974613|NCT01665144|141456014|SUPERIORITY||Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|1.359||0.3671|TWO_SIDED|95.0|-3.89|1.44|||Repeated measures model|||Month 24||1.44|-3.89|0.3671
70974614|NCT01665144|141456015|SUPERIORITY||Rate ratio|0.126|||<|0.0001|TWO_SIDED|95.0|0.083|0.191|||Negative binomial regression model|||Month 12||0.191|0.083|<0.0001
70974615|NCT01665144|141456015|SUPERIORITY||Rate ratio|0.178|||<|0.0001|TWO_SIDED|95.0|0.087|0.362|||Negative binomial regression model|||Month 24||0.362|0.087|<0.0001
70974616|NCT01665144|141456016|SUPERIORITY||Rate ratio|0.266|||<|0.0001|TWO_SIDED|95.0|0.215|0.328|||Regression model|Repeated measures negative binomial regression model||Month 12||0.328|0.215|<0.0001
70974617|NCT01665144|141456016|SUPERIORITY||Rate ratio|0.142|||<|0.0001|TWO_SIDED|95.0|0.103|0.196|||Regression model|Repeated measures negative binomial regression model||Month 24||0.196|0.103|<0.0001
70974618|NCT01665144|141456017|SUPERIORITY||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.0367|<|0.0001|TWO_SIDED|95.0|0.103|0.247|||Repeated measures model|||Month 12||0.247|0.103|<0.0001
70974619|NCT01665144|141456017|SUPERIORITY||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.0549||0.0196|TWO_SIDED|95.0|0.021|0.236|||Repeated measures model|||Month 24||0.236|0.021|0.0196
70974620|NCT01665144|141456018|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.68|1.11|||Cox proportional hazard model|||Without superimposed relapses at baseline||1.11|0.68|
70974621|NCT01665144|141456018|SUPERIORITY||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.49|0.91|||Cox proportional hazard model|||With superimposed relapses at baseline||0.91|0.49|
70974622|NCT01665144|141456018|SUPERIORITY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.69|1.06|||Cox proportional hazard model|||Without superimposed relapses post-treatment||1.06|0.69|
70974623|NCT01665144|141456018|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.53|1.19|||Cox proportional hazard model|||With superimposed relapses post-treatment||1.19|0.53|
70974624|NCT01665144|141456019|SUPERIORITY||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.46|0.91|||Cox proportional hazard model|||Rapidly evolving patients||0.91|0.46|
71095492|NCT00433290|141699342|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Week 13 Change from Baseline. Treatment effects and interaction effects were evaluated based on two-sided significance level of 0.05. No adjustments for multiple comparisons were made.|Mixed Models Analysis|Repeated Measures Model: Change=Treatment,NSAID use, Pooled Investigator, Visit, Baseline, Treatment\*Visit, Baseline\*Visit||Null hypothesis=the difference in the BPI average pain score between the duloxetine and placebo treatment goups at the last visit of the treatment phase is zero.||||<0.001
71095493|NCT00433290|141699343|SUPERIORITY_OR_OTHER|||||||0.164||95.0|||||ANCOVA|Model: PGI-Improvement=Treatment, Pooled Investigator, baseline severity and NSAID used for main effect p-values.||||||0.164
71095494|NCT00433290|141699344|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value for Change from Baseline (change = endpoint - baseline)|ANCOVA|Model: Change=Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.016
71095495|NCT00433290|141699345|SUPERIORITY_OR_OTHER|||||||0.068||95.0||||P-value for Change from Baseline. Change = Week 13 value minus baseline value.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.068
71095496|NCT00433290|141699346|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||P-value for Change from Baseline. Change = Week 13 value minus baseline value.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.064
70921889|NCT00976495|141333909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|2.3613|||TWO_SIDED|95.0|-7.11|2.31|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||2.31|-7.11|
70921890|NCT00976495|141333909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.26|STANDARD_ERROR_OF_MEAN|2.4112|||TWO_SIDED|95.0|-1.55|8.08|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||8.08|-1.55|
70921891|NCT00976495|141333910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.38|STANDARD_ERROR_OF_MEAN|2.5072|||TWO_SIDED|95.0|-9.38|0.63|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||0.63|-9.38|
70921892|NCT00976495|141333910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91|STANDARD_ERROR_OF_MEAN|2.5474|||TWO_SIDED|95.0|-4.18|5.99|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||5.99|-4.18|
70921893|NCT00976495|141333911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|2.7812|||TWO_SIDED|95.0|-5.39|5.71|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||5.71|-5.39|
70921894|NCT00976495|141333911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.31|STANDARD_ERROR_OF_MEAN|2.8135|||TWO_SIDED|95.0|1.7|12.93|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||12.93|1.70|
70921895|NCT04992390|141334079|SUPERIORITY|Poisson regression was performed with baseline measure and binary arm status included as fixed effect covariates. Various regression models for count data were compared to find the best fitting model. Visual exploratory data and model evaluation showed that the Zero Inflated Negative Binomial (ZINB) regression model provided the best fit and was used as the model for the ITT analysis of the primary outcome.|Incidence Rate Ratio|0.31|||<=|0.001|TWO_SIDED|95.0|0.2|0.48||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Poisson|||For more information on analysis models see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|See also Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|0.48|0.20|<= 0.001
70921896|NCT04992390|141334080|SUPERIORITY|Single level general Poisson regression was used to quantify within arm changes of number of intrusive memories in the delayed intervention arm, comparing pre-intervention (week 4) to post-intervention (week 8).|Incidence Rate Ratio|0.31|||<=|0.001|TWO_SIDED|95.0|0.21|0.45||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Poisson|Single level general Poisson regression was used to quantify within arm changes of number of intrusive memories pre- to post-intervention.||Within the comparator arm, where participants had delayed access to the intervention (i.e., delayed arm crossover), the number of intrusive memories in week 8 was compared to week 4. For full information about statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|For full results see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|0.45|0.21|<= 0.001
70974625|NCT01665144|141456019|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.69|1.09|||Cox proportional hazard model|||Not rapidly evolving patients||1.09|0.69|
71095497|NCT00433290|141699347|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value for Change in Weekly 24-Hour Average Pain. Change = endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.008
71095498|NCT00433290|141699347|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-value for Change in Weekly 24-Hour Worst Pain. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.047
71095499|NCT00433290|141699348|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.009
71095500|NCT00433290|141699349|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71095501|NCT00433290|141699350|SUPERIORITY_OR_OTHER|||||||0.897||95.0||||P-value for Mental Component Summary Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.897
71095502|NCT00433290|141699350|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Physical Component Summary Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||<0.001
70974626|NCT01665144|141456020|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.65|0.99|||Cox proportional hazard model|||With moderate or severe course of disease||0.99|0.65|
70974627|NCT01665144|141456020|SUPERIORITY||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.47|1.13|||Cox proportional hazard model|||Without moderate or severe course of disease||1.13|0.47|
71033659|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|||<|0.001|TWO_SIDED|95.0|1.23|1.97||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||1.97|1.23|<0.001
71154278|NCT04972162|141801174|NON_INFERIORITY|Non-inferiority tests compared the subject´s perceived hearing aid benefit when the hearing aid was standard-of-care fitted compared to Web-App fitted by the subject. The non-inferiority margins are the minimum clinically important differences on each of the 3 communication benefit subscales as described by Cox \& Alexander (Ear and Hearing 1995;16;176-186). These literature values are as follows: Ease of Communication (EC): 26, Background Noise (BN): 27, Reverberant Room (RV): 28|Mean Difference (Final Values)|0.98|||<|0.0001|TWO_SIDED|95.0|-4.6|6.5||Threshold for statistical significance was p =0.05. p-value was calculated using the estimated difference of benefits, calculating a new t-statistic by subtracting the applicable non-inf. margin from the difference and dividing by standard error.|ANOVA|repeated measures ANOVA where factors are order and treatment is device with patient as a random effect. Added interaction term of treatment and order|Difference calculated as benefit(standard-of-care fit) - benefit(web-app-fit)|Results for Reverberant Room Subscale. Null hypothesis: benefit(standard-of-care fit) - benefit(web-app-fit) \< noninferiority margin for all subscales. Each subscale was analyzed using an rm-ANOVA in which the repeated factors are order \& treatment; no between-group factors. Interaction term was order x treatment. ITT population includes 2 subjects who withdrew. It was concluded that their primary endpoint data was missing for cause and their APHAB benefit scores were imputed as 0.||6.5|-4.6|<0.0001
71033660|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17|||<|0.001|TWO_SIDED|95.0|0.81|1.54||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||1.54|0.81|<0.001
71033661|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|||<|0.001|TWO_SIDED|95.0|1.2|2.0||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||2.00|1.20|<0.001
71033662|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.58|||<|0.001|TWO_SIDED|95.0|1.19|1.98||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||1.98|1.19|<0.001
71033663|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|||<|0.001|TWO_SIDED|95.0|0.73|1.52||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||1.52|0.73|<0.001
71154279|NCT00336024|141801179|SUPERIORITY|||||||0.35|||||||Chi-squared|||The CR rates between these two groups will be compared at a significance level of 0.1 using one-sided Chi-square test.||||0.35
71154280|NCT00336024|141801181|SUPERIORITY|||||||0.2|||||||Log Rank|||The difference in incidence for the two treatment regimens will be compared using a one-sided log-rank test with a significance level 0.1.||||0.2
71154281|NCT00336024|141801182|SUPERIORITY|||||||1|||||||Fisher Exact|||The two groups will be compared for patterns of failure to detect a statistically significant difference using Fisher exact test.||||1.00
71154282|NCT00336024|141801183|SUPERIORITY|||||||0.74|||||||Log Rank|||Difference in incidence for the two treatment regimens will be compared using log-rank test.||||0.74
71154283|NCT00336024|141801184|SUPERIORITY|||||||1|||||||Fisher Exact|||The rate of acute hearing loss between two treatment regimens will be be compared using Fisher exact test.||||1.00
71033664|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.49|||<|0.001|TWO_SIDED|95.0|1.08|1.9||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||1.90|1.08|<0.001
71033665|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.56|||<|0.001|TWO_SIDED|95.0|1.16|1.97||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||1.97|1.16|<0.001
71033666|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.13|||<|0.001|TWO_SIDED|95.0|0.72|1.53||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||1.53|0.72|<0.001
71154284|NCT00336024|141801190|SUPERIORITY|||||||0.8|||||||Fisher Exact|||The rate of chronic hearing loss between two treatment regimens will be be compared using Fisher exact test.||||0.8
71154285|NCT00336024|141801191|SUPERIORITY|||||||0.27|||||||Chi-squared|||Rates of gastrointestinal toxicities in Induction Phase I. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.27
71154286|NCT00336024|141801191|SUPERIORITY|||||||0.07|||||||Chi-squared|||Rates of gastrointestinal toxicities in Induction Phase II. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.07
71154287|NCT00336024|141801191|SUPERIORITY|||||||0.2|||||||Chi-squared|||Rates of gastrointestinal toxicities in Induction Phase III. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.2
71154288|NCT00336024|141801191|SUPERIORITY|||||||0.4|||||||Chi-squared|||Rates of gastrointestinal toxicities in Consolidation Phase 1. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.4
71154289|NCT00336024|141801191|SUPERIORITY|||||||0.38|||||||Chi-squared|||Rates of gastrointestinal toxicities in Consolidation Phase 2. The difference in the number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.38
71154290|NCT00336024|141801191|SUPERIORITY|||||||0.7|||||||Chi-squared|||Rates of gastrointestinal toxicities in Consolidation Phase III. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.7
71154291|NCT00336024|141801192|SUPERIORITY|||||||0.08|||||||Chi-squared|||Rates of nutritional toxicities in Induction Phase I. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.08
71154292|NCT00336024|141801192|SUPERIORITY|||||||0.9|||||||Chi-squared|||Rates of nutritional toxicities in Induction Phase II. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.9
71154293|NCT00336024|141801192|SUPERIORITY|||||||0.17|||||||Chi-squared|||Rates of nutritional toxicities in Induction Phase III. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.17
71154294|NCT00336024|141801192|SUPERIORITY|||||||0.3|||||||Chi-squared|||Rates of nutritional toxicities in Consolidation Phase I. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.3
71095503|NCT00433290|141699350|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value for Bodily Pain Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.004
71033667|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.38|||<|0.001|TWO_SIDED|95.0|0.97|1.79||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||1.79|0.97|<0.001
71095504|NCT00433290|141699350|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-value for General Health Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.051
71095505|NCT00433290|141699350|SUPERIORITY_OR_OTHER|||||||0.508||95.0||||P-value for Mental Health Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.508
71033668|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.55|||<|0.001|TWO_SIDED|95.0|1.14|1.95||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||1.95|1.14|<0.001
71033669|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02|||<|0.001|TWO_SIDED|95.0|0.62|1.43||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||1.43|0.62|<0.001
70974628|NCT01128829|141456021|SUPERIORITY_OR_OTHER|||||||0.025|||||||t-test, 2 sided|||Each subject served as their own control. We compared insulin concentrations when subjects consumed sucralose before a glucose load (experimental condition) with those on the day consumed water before a glucose load (control condition).||||0.025
70974629|NCT01913483|141456030|SUPERIORITY|||||||0.9458||||||The primary endpoint analysis was to assess the superiority of bivalirudin versus UFH in BARC ≥3 bleeds within the 48 hours post study drug initiation or at hospital discharge, whichever occurred first.|Chi-squared|||Assuming a bleeding event rate of 5.0% in the heparin control treatment group and 3.2% in the bivalirudin group (36% relative risk reduction, a sample size of 3900 participants was to provide more than 80% power with a two-tailed alpha level of 0.05). This estimate took into consideration that the interim efficacy analysis was to be performed when approximately 70% of participants were enrolled using the O'Brien-Fleming alpha spending function.||||0.9458
70974630|NCT02302963|141456033|OTHER|Analysis of Variance|||||<|0.001|||||||GLM Repeated Measures|Repeated-measures general linear model was used to compare HCLC versus SAP data. A P-value of \< 0.001 was considered the threshold for significance.||||||<0.001
71033670|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.35|||<|0.001|TWO_SIDED|95.0|0.93|1.77||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||1.77|0.93|<0.001
71033671|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|||<|0.001|TWO_SIDED|95.0|0.97|1.81||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||1.81|0.97|<0.001
71033672|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04|||<|0.001|TWO_SIDED|95.0|0.63|1.46||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||1.46|0.63|<0.001
71095506|NCT00433290|141699350|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-value for Physical Functioning Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.019
71095507|NCT00433290|141699350|SUPERIORITY_OR_OTHER|||||||0.415||95.0||||P-value for Role-Emotional Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.415
71095508|NCT00433290|141699350|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value for Role-Physical Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.006
71095509|NCT00433290|141699350|SUPERIORITY_OR_OTHER|||||||0.342||95.0||||P-value for Social Functioning Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.342
70974631|NCT00915343|141456038|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.806|||<|0.0001|TWO_SIDED|95.0|0.753|0.862||Comparison of log S-cortisol AUC between OD and TID regimens was adjusted for both period effect and subject effect using generalized linear model (GLM) in statistical analysis system (SAS).|ANOVA||The quotient was defined as AUC0-24h for OD treatment divided by AUC0-24h for TID treatment.|||0.862|0.753|<0.0001
70974632|NCT00915343|141456039|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-111.989|||<|0.0001|TWO_SIDED|95.0|-133.98|89.999|||Fisher's non-parametric permutation test|||||89.999|-133.980|<0.0001
70974633|NCT00915343|141456040|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|110.417||||0.0357|TWO_SIDED|95.0|16.755|204.078|||Fisher's non-parametric permutation test|||||204.078|16.755|0.0357
70974634|NCT00915343|141456041|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-38.076|||<|0.0001|TWO_SIDED|95.0|-50.276|25.876|||Fisher's non-parametric permutation test|||||25.876|-50.276|<0.0001
70974635|NCT00915343|141456042|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-65.782||||0.0033|TWO_SIDED|95.0|-109.201|22.362|||Fisher's non-parametric permutation test|||||22.362|-109.201|0.0033
70974636|NCT00915343|141456043|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-148.015|||<|0.0001|TWO_SIDED|95.0|-189.469|-106.561|||Fisher's non-parametric permutation test|||||-106.561|-189.469|<0.0001
71033673|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29|||<|0.001|TWO_SIDED|95.0|0.87|1.71||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||1.71|0.87|<0.001
71033674|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|||<|0.001|TWO_SIDED|95.0|0.97|1.81||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||1.81|0.97|<0.001
71033675|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.98|||<|0.001|TWO_SIDED|95.0|0.56|1.39||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||1.39|0.56|<0.001
71033676|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25|||<|0.001|TWO_SIDED|95.0|0.82|1.68||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||1.68|0.82|<0.001
71095510|NCT00433290|141699350|SUPERIORITY_OR_OTHER|||||||0.135||95.0||||P-value for Vitality Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.135
70974637|NCT00915343|141456044|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-108.306|||<|0.0001|TWO_SIDED|95.0|-140.193|-76.42|||Fisher's non-parametric permutation test|||||-76.420|-140.193|<0.0001
70974638|NCT00915343|141456045|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|0.27||||0.0214|TWO_SIDED|95.0|0.028|0.512|||Fisher's non-parametric permutation test|||||0.512|0.028|0.0214
70974639|NCT00915343|141456046|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-1.042||||0.0714|TWO_SIDED|95.0|-2.098|0.015|||Fisher's non-parametric permutation test|||||0.015|-2.098|0.0714
70974640|NCT00915343|141456047|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.007||||0.6687|TWO_SIDED|95.0|-0.038|0.024|||Fisher's non-parametric permutation test|||||0.024|-0.038|0.6687
70974641|NCT00915343|141456048|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|0.049||||0.028|TWO_SIDED|95.0|0.006|0.093|||Fisher's non-parametric permutation test|||||0.093|0.006|0.0280
70974642|NCT00915343|141456049|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|5.509||||0.0003|TWO_SIDED|95.0|0.751|10.268|||Fisher's non-parametric permutation test|||||10.268|0.751|0.0003
70974643|NCT00915343|141456050|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-13.8|||<|0.0001|TWO_SIDED|95.0|-20.533|-7.067|||Fisher's non-parametric permutation test|||||-7.067|-20.533|<0.0001
70974644|NCT00915343|141456051|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|1.064||||0.0002|TWO_SIDED|95.0|1.032|1.097|||ANOVA||The quotient was defined as AUC0-4h for OD treatment divided by AUC0-4h for TID treatment.|AUC0-4h||1.097|1.032|0.0002
71033677|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46|||<|0.001|TWO_SIDED|95.0|1.03|1.89||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||1.89|1.03|<0.001
70974645|NCT00915343|141456051|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.617|||<|0.0001|TWO_SIDED|95.0|0.563|0.675|||ANOVA||The quotient was defined as AUC4-12h for OD treatment divided by AUC4-12h for TID treatment.|AUC4-12h||0.675|0.563|<0.0001
70974646|NCT00915343|141456051|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.472|||<|0.0001|TWO_SIDED|95.0|0.424|0.525|||ANOVA||The quotient was defined as AUC6-12h for OD treatment divided by AUC6-12h for TID treatment.|AUC6-12h||0.525|0.424|<0.0001
70974647|NCT00915343|141456051|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.588||||0.0003|TWO_SIDED|95.0|0.446|0.775|||ANOVA||The quotient was defined as AUC12-24h for OD treatment divided by AUC12-24h for TID treatment.|AUC12-24h||0.775|0.446|0.0003
70974648|NCT00915343|141456051|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.894|||<|0.0001|TWO_SIDED|95.0|0.856|0.935|||ANOVA||The quotient was defined as AUC0-10h for OD treatment divided by AUC0-10h for TID treatment.|AUC0-10h||0.935|0.856|<0.0001
70974649|NCT00915343|141456051|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.695|||<|0.0001|TWO_SIDED|95.0|0.632|0.765|||ANOVA||The quotient was defined as AUC4-10h for OD treatment divided by AUC4-10h for TID treatment.|AUC4-10h||0.765|0.632|<0.0001
71033678|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03|||<|0.001|TWO_SIDED|95.0|0.6|1.45||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||1.45|0.60|<0.001
71033679|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21|||<|0.001|TWO_SIDED|95.0|0.77|1.64||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||1.64|0.77|<0.001
71033680|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44|||<|0.001|TWO_SIDED|95.0|1.0|1.87||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||1.87|1.00|<0.001
71154295|NCT00336024|141801192|SUPERIORITY|||||||0.26|||||||Chi-squared|||Rates of nutritional toxicities in Consolidation Phase II. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.26
70974650|NCT00915343|141456051|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.54|||<|0.0001|TWO_SIDED|95.0|0.482|0.605|||ANOVA||The quotient was defined as AUC6-10h for OD treatment divided by AUC6-10h for TID treatment.|AUC6-10h||0.605|0.482|<0.0001
70974651|NCT00915343|141456051|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.412|||<|0.0001|TWO_SIDED|95.0|0.338|0.504|||ANOVA||The quotient was defined as AUC10-24h for OD treatment divided by AUC10-24h for TID treatment.|AUC10-24h||0.504|0.338|<0.0001
70974652|NCT00915343|141456051|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.776|||<|0.0001|TWO_SIDED|95.0|0.714|0.843|||ANOVA||The quotient was defined as AUC(0-inf) for OD treatment divided by AUC(0-inf) for TID treatment.|AUC(0-inf)||0.843|0.714|<0.0001
70974653|NCT00915343|141456051|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|1.069||||0.877|TWO_SIDED|95.0|0.453|2.521|||ANOVA||The quotient was defined as AUC(24h-inf) for OD treatment divided by AUC(24h-inf) for TID treatment.|AUC(24h-inf)||2.521|0.453|0.8770
70974654|NCT00915343|141456052|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.806|||<|0.0001|TWO_SIDED|95.0|0.753|0.862|||ANOVA||The quotient was defined as AUCtau for OD treatment divided by AUCtau for TID treatment.|||0.862|0.753|<0.0001
70974655|NCT00915343|141456053|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.79|||<|0.0001|TWO_SIDED|95.0|0.734|0.851|||ANOVA||The quotient was defined as AUCtau/dose for OD treatment divided by AUCtau/dose for TID treatment.|||0.851|0.734|<0.0001
70974656|NCT00915343|141456054|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.785|||<|0.0001|TWO_SIDED|95.0|0.741|0.831|||ANOVA||The quotient was defined as AUC0-24h/dose for OD treatment divided by AUC0-24h/dose for TID treatment.|||0.831|0.741|<0.0001
70974657|NCT00915343|141456055|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.885|||<|0.0001|TWO_SIDED|95.0|0.844|0.926|||ANOVA||The quotient was defined as AUC0-10h/dose for OD treatment divided by AUC0-10h/dose for TID treatment.|||0.926|0.844|<0.0001
70974658|NCT00915343|141456056|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|1.053||||0.002|TWO_SIDED|95.0|1.02|1.086|||ANOVA||The quotient was defined as AUC0-4h/dose for OD treatment divided by AUC0-4h/dose for TID treatment.|||1.086|1.020|0.0020
70974659|NCT00915343|141456057|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.001|||<|0.0001|TWO_SIDED|95.0|-0.001|0.0|||Fisher's non-parametric permutation test|||||-0.000|-0.001|<0.0001
71033681|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04|||<|0.001|TWO_SIDED|95.0|0.61|1.48||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||1.48|0.61|<0.001
71033682|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25|||<|0.001|TWO_SIDED|95.0|0.81|1.68||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||1.68|0.81|<0.001
71154296|NCT00336024|141801192|SUPERIORITY|||||||0.17|||||||Chi-squared|||Rates of nutritional toxicities in Consolidation Phase III. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.17
70974660|NCT00915343|141456058|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.001|||<|0.0001|TWO_SIDED|95.0|-0.002|-0.001|||Fisher's non-parametric permutation test|||||-0.001|-0.002|<0.0001
70921897|NCT04992390|141334080|SUPERIORITY|Single level general Poisson regression was used to quantify within arm changes of number of intrusive memories in the immediate intervention arm, comparing pre-intervention (run-in/screening week) to post-intervention (week 4).|Incidence Rate Ratio|0.22|||<|0.001|TWO_SIDED|95.0|0.1|0.45||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Poisson|Single level general Poisson regression was used to quantify within arm changes of number of intrusive memories pre- to post-intervention.||Within the immediate intervention arm, where participants had immediate access to the intervention, the number of intrusive memories in Week 4 was compared to the run-in/screening week. For full information about statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0||0.45|0.10|<0.001
70921898|NCT04992390|141334081|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-2.63|||<=|0.001|TWO_SIDED|95.0|-3.72|-1.54||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Intrusive memory ratings, 'How distressing were your intrusive memories?' (treatment effects for between-arm comparisons) at week 4. For full information on statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-1.54|-3.72|<= 0.001
70921899|NCT04992390|141334081|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-3.21|||<=|0.001|TWO_SIDED|95.0|-4.28|-2.15||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Intrusive memory ratings, 'How much did they disrupt your concentration?' (treatment effects for between-arm comparisons) at week 4. For full information on statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-2.15|-4.28|<= 0.001
70974661|NCT00915343|141456059|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.055||||0.7827|TWO_SIDED|95.0|-0.444|0.334|||Fisher's non-parametric permutation test|||||0.334|-0.444|0.7827
70974662|NCT00915343|141456060|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.001||||0.0015|TWO_SIDED|95.0|-0.001|0.0|||Fisher's non-parametric permutation test|||||-0.000|-0.001|0.0015
71033683|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|||<|0.001|TWO_SIDED|95.0|0.96|1.82||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||1.82|0.96|<0.001
71033684|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|||<|0.001|TWO_SIDED|95.0|0.53|1.39||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||1.39|0.53|<0.001
71033685|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|||<|0.001|TWO_SIDED|95.0|0.75|1.64||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||1.64|0.75|<0.001
71033686|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21|||<|0.001|TWO_SIDED|95.0|0.77|1.65||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||1.65|0.77|<0.001
71033687|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93|||<|0.001|TWO_SIDED|95.0|0.49|1.36||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||1.36|0.49|<0.001
71033688|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07|||<|0.001|TWO_SIDED|95.0|0.6|1.53||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||1.53|0.60|<0.001
71033689|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|||<|0.001|TWO_SIDED|95.0|0.66|1.58||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||1.58|0.66|<0.001
71033690|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.87|||<|0.001|TWO_SIDED|95.0|0.42|1.33||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||1.33|0.42|<0.001
71033691|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06|||<|0.001|TWO_SIDED|95.0|0.61|1.51||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||1.51|0.61|<0.001
71033692|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03|||<|0.001|TWO_SIDED|95.0|0.58|1.48||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||1.48|0.58|<0.001
71033693|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|||<|0.001|TWO_SIDED|95.0|0.52|1.4||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||1.40|0.52|<0.001
71033694|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77||||0.001|TWO_SIDED|95.0|0.31|1.24||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||1.24|0.31|0.001
71033695|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|||<|0.001|TWO_SIDED|95.0|0.36|1.28||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||1.28|0.36|<0.001
71033696|NCT00913627|141577229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.88|||<|0.001|TWO_SIDED|95.0|0.42|1.33||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||1.33|0.42|<0.001
71033697|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.034|TWO_SIDED|95.0|0.02|0.57||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.57|0.02|0.034
71033698|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.111|TWO_SIDED|95.0|-0.05|0.49||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.49|-0.05|0.111
71033699|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.125|TWO_SIDED|95.0|-0.06|0.48||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.48|-0.06|0.125
71095511|NCT00433290|141699351|SUPERIORITY_OR_OTHER|||||||0.209||95.0||||P-value for EQ-5D Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change=Treament, Pooled Investigator, NSAID use and Baseline for main effect p-value.||||||0.209
71095512|NCT00433290|141699352|SUPERIORITY_OR_OTHER|||||||0.871||95.0||||P-value for Change from Baseline. Change = Week 13 value minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.871
71095513|NCT00433290|141699353|SUPERIORITY_OR_OTHER|||||||0.138||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.138
71095514|NCT00433290|141699354|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.003
71095515|NCT00433290|141699355|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.015
71095516|NCT00433290|141699356|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||<0.001
71095517|NCT00433290|141699356|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for direct analgesic effect. The null hypothesis was tested by testing a1=0 versus a1≠0.|Regression, Linear|||Path analysis was used to test null hypothesis that change in BPI average pain severity depends on improvement of BDI or HADS-A, versus improvement in BPI average pain severity is due to a direct analgesic effect of treatment and not dependent on improvement in depression or anxiety symptoms. Model:Change in BPI average pain score=a0+a1\*treatment group+a2\*change in BDI total+a3\*change in HADS-A+a4\*BL of BPI average pain+a5\*BL of BDI total+a6\*BL of HADS-A.||||0.002
71095518|NCT00433290|141699357|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value for Change from Baseline. Change=Endpoint minus baseline.|ANCOVA|||||||0.007
71095519|NCT00433290|141699358|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.050
70974663|NCT00915343|141456061|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|6.098|||<|0.0001|TWO_SIDED|95.0|2.94|12.646|||ANOVA||The quotient was defined as AUC Extrapolation for OD treatment divided by AUC Extrapolation for TID treatment.|||12.646|2.940|<0.0001
70974664|NCT00915343|141456062|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|33.532||||0.0396|TWO_SIDED|95.0|1.734|65.329|||Fisher's non-parametric permutation test|||||65.329|1.734|0.0396
70974665|NCT00915343|141456063|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.08||||0.1032|TWO_SIDED|95.0|-0.017|0.177|||Fisher's non-parametric permutation test|||||0.177|-0.017|0.1032
70974666|NCT00915343|141456064|SUPERIORITY_OR_OTHER_LEGACY||least square mean|-0.078||||0.3767|TWO_SIDED|95.0|-0.25|0.094|||Fisher's test|Fisher's non||Patient||0.094|-0.250|0.3767
70974667|NCT00915343|141456064|SUPERIORITY_OR_OTHER_LEGACY||least square mean|-0.064||||0.4625|TWO_SIDED|95.0|-0.235|0.107|||Fisher's test|Fisher's non||Investigator||0.107|-0.235|0.4625
70974668|NCT00915343|141456065|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6072|TWO_SIDED||||||Sign test|||Patient||||0.6072
71095520|NCT00433290|141699359|SUPERIORITY_OR_OTHER|||||||0.913||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.913
71095521|NCT00433290|141699360|SUPERIORITY_OR_OTHER|||||||0.066||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.066
71095522|NCT00433290|141699361|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.001
71095523|NCT00433290|141699362|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.260
71095524|NCT00433290|141699363|SUPERIORITY_OR_OTHER|||||||0.489||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.489
71095525|NCT00433290|141699364|SUPERIORITY_OR_OTHER|||||||0.131||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.131
71095526|NCT00433290|141699365|SUPERIORITY_OR_OTHER|||||||0.082||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.082
70974669|NCT00915343|141456065|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Sign test|||Investigator||||1.0000
70974670|NCT00915343|141456066|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.6||||0.3332|TWO_SIDED||||||Fisher's test|Fisher's non-parametric two-sample permutation test||Comparison of Quality of Life (QoL) Assessed by Short Form-36 Survey (SF-36) For Physical Component Score||||0.3332
71095527|NCT00433290|141699367|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Alkaline Phosphatase Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||<0.001
71095528|NCT00433290|141699367|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value for AST Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||0.010
71095529|NCT00433290|141699367|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value for GGT Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||0.023
71095530|NCT00433290|141699368|SUPERIORITY_OR_OTHER|||||||0.042||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||0.042
71095531|NCT00433290|141699369|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||0.005
71095532|NCT00433290|141699370|SUPERIORITY_OR_OTHER|||||||0.285||95.0||||P-value for SBP Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||0.285
71095533|NCT00433290|141699370|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||P-value for DBP Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||0.668
71095534|NCT00433290|141699371|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||<0.001
71095535|NCT00433290|141699372|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||t-test, 2 sided|||||||0.040
71095536|NCT01917773|141699380|NON_INFERIORITY_OR_EQUIVALENCE|"Reported MIs and SDs in healthy volunteers from an adult study were used to calculate sample size (1). A sample size of 13 patients was deemed adequate to detect a 25% change in MI with 80% power.~Reference: Rao SS, Kavelock R, Beaty J, Ackerson K, et al. Effects of fat and carbohydrate meals on colonic motor response. Gut. Feb 2000;46(2):205-211."||||||0.087|TWO_SIDED||||||Wilcoxon signed rank test|||The Wilcoxon signed rank test was used to analyze change in MI at 15 minutes. Values were considered to be significant if P \<0.05.||||0.087
71095537|NCT01917773|141699380|SUPERIORITY_OR_OTHER|||||||0.552|TWO_SIDED||||||Wilcoxon signed rank test|||The Wilcoxon signed rank test was used to analyze change in MI at 30 minutes. Values were considered to be significant if P \<0.05.||||0.552
70974671|NCT00915343|141456066|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|0.9||||0.3405|TWO_SIDED||||||Fisher's test|Fisher's non-parametric two-sample permutation test||Comparison of Quality of Life (QoL) Assessed by Short Form-36 Survey (SF-36) For Mental Component Score||||0.3405
70974672|NCT00915343|141456067|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8418|TWO_SIDED||||||Wilcoxon Signed Rank|||Change From Baseline to 6 months in Quality of Life (QoL) Assessed by Short Form-36 Survey (SF-36) For Physical Component Score||||0.8418
70974673|NCT00915343|141456067|SUPERIORITY_OR_OTHER_LEGACY|||||||0.355|TWO_SIDED||||||Wilcoxon Signed Rank test|||Change From Baseline to 6 months in Quality of Life (QoL) Assessed by Short Form-36 Survey (SF-36) For Mental Component Score||||0.3550
70974674|NCT00915343|141456068|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-2.9||||0.0823|TWO_SIDED||||||Fisher's|Fisher's non-parametric two-sample permutation test||||||0.0823
70974675|NCT00915343|141456069|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5982|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.5982
70974676|NCT00915343|141456070|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|2.3||||0.0632|TWO_SIDED||||||Fisher's test|Fisher's non-parametric two-sample permutation test||||||0.0632
70974677|NCT00915343|141456071|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8676|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.8676
70974678|NCT00915343|141456072|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.9700
70974679|NCT00915343|141456073|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2624|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.2624
70974680|NCT00915343|141456074|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|1.28|||||TWO_SIDED|||||||||||||
70974681|NCT00915343|141456076|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Sign test|||||||<0.0001
70974682|NCT00915343|141456077|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-272.3||||0.0034|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.0034
70974683|NCT01920711|141456078|SUPERIORITY||Rate Ratio|0.8698||||0.0587|TWO_SIDED|95.0|0.7526|1.0052||1-sided p-value 0.0294|Proportional Rates Model (LWYY)|Treatment as fixed-effect factor and stratified by region and with robust variance estimate.||Primary Composite Events||1.0052|0.7526|0.0587
70974684|NCT01920711|141456078|SUPERIORITY||Rate Ratio|0.8511||||0.0556|TWO_SIDED|95.0|0.7216|1.0039||1-sided p-value 0.0278|Joint Frality Model|Treatment and region as fixed-effect factors||Total Hospitalizations for heart failure||1.0039|0.7216|0.0556
70974685|NCT01920711|141456078|SUPERIORITY||Hazard Ratio (HR)|0.9531||||0.6241|TWO_SIDED|95.0|0.7863|1.1551||1-sided p-value 0.3120|Cox's proportional hazard model|||Cardiovascular Death||1.1551|0.7863|0.6241
70974686|NCT01920711|141456079|SUPERIORITY||Least Squares Mean of Difference|1.0264||||0.051|TWO_SIDED|95.0|-0.0047|2.0576|||Mixed Models Analysis|||Clinical Summary Score||2.0576|-0.0047|0.0510
70974687|NCT01920711|141456080|SUPERIORITY||Odds Ratio (OR)|1.4475||||0.0035|TWO_SIDED|95.0|1.1294|1.8552|||Repeated measures cumulative odds model|The response variable is the change from baseline to any scheduled time points up to Month 8.||NYHA Class Change||1.8552|1.1294|0.0035
70974688|NCT01920711|141456081|SUPERIORITY||Hazard Ratio (HR)|0.5041||||0.0014|TWO_SIDED|95.0|0.3312|0.7673|||Cox's proportional hazards model|Treatment as fixed factor and stratified by region.||Composite renal endpoint||0.7673|0.3312|0.0014
70974689|NCT01920711|141456081|SUPERIORITY||Hazard Ratio (HR)|0.9295||||0.9588|TWO_SIDED|95.0|0.0581|14.861|||Cox's proportional hazards model|Treatment as fixed factor and stratified by region.||Renal Death||14.861|0.0581|0.9588
70974690|NCT01920711|141456081|SUPERIORITY||Hazard Ratio (HR)|0.5774||||0.2484|TWO_SIDED|95.0|0.2272|1.4672|||Cox's proportional hazards model|Treatment as fixed factor and stratified by region.||Reaching ESRD||1.4672|0.2272|0.2484
70974691|NCT01920711|141456081|SUPERIORITY||Hazard Ratio (HR)|0.4407||||0.0004|TWO_SIDED|95.0|0.2798|0.6942|||Cox's proportional hazards model|Treatment as fixed factor and stratified by region.||\>=50% decline in eGFR from baseline||0.6942|0.2798|0.0004
70974692|NCT01920711|141456082|SUPERIORITY||Hazard Ratio (HR)|0.9696||||0.6846|TWO_SIDED|95.0|0.8352|1.1255|||Cox's proportional hazards model|Treatment as fixed factor and stratified by region.||All-cause mortality||1.1255|0.8352|0.6846
70974693|NCT03434379|141456083|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.0006|TWO_SIDED|95.0|0.42|0.79|||Log Rank|||At CCOD 18 months; Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline alpha-fetoprotein (AFP: \<400 vs. \>/= 400 ng/mL).||0.79|0.42|0.0006
70974694|NCT03434379|141456083|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0009|TWO_SIDED|95.0|0.52|0.85|||Log Rank|||At CCOD 30 months; Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline alpha-fetoprotein (AFP: \<400 vs. \>/= 400 ng/mL).||0.85|0.52|0.0009
70974695|NCT03434379|141456084|SUPERIORITY||Hazard Ratio (HR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.47|0.76|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.76|0.47|<0.0001
70974696|NCT03434379|141456085|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.0026|TWO_SIDED|95.0|0.25|0.76|||Log Rank|||At CCOD 18 months; Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.76|0.25|0.0026
70974697|NCT03434379|141456085|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0019|TWO_SIDED|95.0|0.35|0.8|||Log Rank|||At CCOD 30 months; Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.80|0.35|0.0019
70974698|NCT03434379|141456086|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.0117|TWO_SIDED|95.0|0.4|0.9|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.90|0.40|0.0117
70974699|NCT03434379|141456087|SUPERIORITY||Odds Ratio (OR)|2.9|||<|0.0001|TWO_SIDED|95.0|1.68|5.01|||Cochran-Mantel-Haenszel|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||5.01|1.68|<0.0001
70974700|NCT03434379|141456088|SUPERIORITY||Odds Ratio (OR)|3.39|||<|0.0001|TWO_SIDED|95.0|2.02|5.71|||Cochran-Mantel-Haenszel|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||5.71|2.02|<0.0001
71095538|NCT01917773|141699380|SUPERIORITY_OR_OTHER|||||||0.807|TWO_SIDED||||||Wilcoxon signed rank test|||The Wilcoxon signed rank test was used to analyze change in MI at 45 minutes. Values were considered to be significant if P \<0.05.||||0.807
71095539|NCT00308685|141699394|OTHER||Difference in adjusted means|5.163||||0.0002|TWO_SIDED|95.0|2.478|7.847||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using an analysis of covariance (ANCOVA) with baseline FEV1 as covariate and fixed effects of pooled center and treatment group.||7.847|2.478|0.0002
71095540|NCT03345095|141699398|SUPERIORITY||Mean Difference (Net)|-6.4||||0.0004|TWO_SIDED|95.0|-8.6|-2.5|||Wilcoxon (Mann-Whitney)|||||-2.5|-8.6|0.0004
71095541|NCT03345095|141699399|SUPERIORITY||Mean Difference (Net)|-0.55||||0.15|TWO_SIDED|95.0|-1.27|0.16|||Wilcoxon (Mann-Whitney)|||||0.16|-1.27|0.15
71095542|NCT01121575|141699430|SUPERIORITY_OR_OTHER||Ratio of adjust geometric mean|69.25|||||TWO_SIDED|90.0|54.22|88.44|||||Ratio of crizotinib + dacomitinib / crizotinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for crizotinib AUClast for participants who had both Day -1 and C2D1 data. Result for the analysis of AUClast was based on data from 11 participants. No statistical analysis was performed for PF-06260182.||88.44|54.22|
71095543|NCT01121575|141699431|SUPERIORITY_OR_OTHER||Ratio of adjust geometric mean|78.84|||||TWO_SIDED|90.0|58.9|105.54|||||Ratio of crizotinib + dacomitinib / crizotinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for crizotinib AUC10 for participants who had both Day -1 and C2D1 data. Result for the analysis of AUC10 was based on data from 6 participants. No statistical analysis was performed for PF-06260182.||105.54|58.90|
71095544|NCT01121575|141699433|SUPERIORITY_OR_OTHER||Ration of adjust geometric mean|70.6|||||TWO_SIDED|90.0|54.71|91.12|||||Ratio of crizotinib + dacomitinib / crizotinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for crizotinib Cmax for participants who had both Day -1 and C2D1 data. Result for the analysis of Cmax was based on data from 11 participants. No statistical analysis was performed for PF-06260182.||91.12|54.71|
71095545|NCT01121575|141699436|SUPERIORITY_OR_OTHER||Ratio of adjust geometric mean|117.81|||||TWO_SIDED|90.0|64.97|213.61|||||Ratio of crizotinib + dacomitinib / dacomitinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for dacomitinib AUClast for participants who had both Day -1 and C2D1 data. Result for the analysis of AUClast was based on data from 3 participants. No statistical analysis was performed for PF-05199265.||213.61|64.97|
71095546|NCT01121575|141699437|SUPERIORITY_OR_OTHER||Ratio of adjust geometric mean|121.9|||||TWO_SIDED|90.0|70.2|211.66|||||Ratio of crizotinib + dacomitinib / dacomitinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for dacomitinib AUC24 for participants who had both Day -1 and C2D1 data. Result for the analysis of AUC24 was based on data from 3 participants. No statistical analysis was performed for PF-05199265.||211.66|70.20|
71095547|NCT01121575|141699439|SUPERIORITY_OR_OTHER||Ratio of adjust geometric mean|130.57|||||TWO_SIDED|90.0|82.46|206.73|||||Ratio of crizotinib + dacomitinib / dacomitinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for dacomitinib Cmax for participants who had both Day -1 and C2D1 data. Result for the analysis of Cmax was based on data from 3 participants. No statistical analysis was performed for PF-05199265.||206.73|82.46|
71095548|NCT00724503|141699448|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.551|TWO_SIDED|95.0|0.77|1.12|||Log Rank|||The null hypothesis tested for the primary efficacy endpoint is rate of progression (months) of SIRT/FOLFOX treatment versus FOLFOX is equal for both groups. The two-sided alternative hypothesis tested with 95% confidence is PFS rate for SIRT/FOLFOX treatment lower to that of FOLFOX.||1.12|0.77|0.551
71095549|NCT00724503|141699449|SUPERIORITY||Hazard Ratio (HR)|0.75|||<|0.05|TWO_SIDED|95.0|||||Log Rank|||A sample size of at least 450 patients for the SIRFLOX study was estimated to be needed to detect an increase in the median PFS at any site from 9.4 months to 12.5 months with 80% power and 95% confidence. Taking into account the number of patients who might receive the alternative treatment or lack of imaging data, the sample size was increased to 530. The Null hypothesis is no difference between the treatment arms with respect to PFS.||||< 0.05
71095550|NCT01186419|141699450|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0765|TWO_SIDED||||||t-test, 2 sided|||||||0.0765
71095551|NCT03921541|141699465|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71095552|NCT03921541|141699466|SUPERIORITY|||||||0.5961|||||||Mixed Models Analysis|||||||0.5961
71095553|NCT03921541|141699467|SUPERIORITY|||||||0.1087|||||||Mixed Models Analysis|||||||0.1087
71095554|NCT03921541|141699468|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71095555|NCT03921541|141699469|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71095556|NCT03921541|141699470|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71095557|NCT03921541|141699472|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|||||||0.0003
71095558|NCT03921541|141699473|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71095559|NCT03921541|141699474|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71095560|NCT03921541|141699475|SUPERIORITY|||||||0.0208|||||||Mixed Models Analysis|||||||0.0208
71095561|NCT03921541|141699476|SUPERIORITY|||||||0.4434|||||||Mixed Models Analysis|||||||0.4434
71095562|NCT03921541|141699477|SUPERIORITY|||||||0.5301|||||||Mixed Models Analysis|||||||0.5301
71095563|NCT03921541|141699478|SUPERIORITY|||||||0.2515|||||||Mixed Models Analysis|||||||0.2515
71095564|NCT01734928|141699522|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.001|TWO_SIDED|95.0|0.49|0.77|||Based on Cox proportional hazards model|||||0.77|0.49|0.001
71095565|NCT01734928|141699523|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.571|TWO_SIDED|95.0|0.77|1.15|||Log Rank|The p-value is based on a stratified log-rank test with stratification factors as above Cox model.|Based on Cox proportional hazards model, comparing the hazard functions associated with treatment groups, stratified by age, prior number of anti-myeloma regimens, and beta-2 macroglobulin at Screening.|||1.15|0.77|0.571
71095566|NCT01734928|141699525|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.064|TWO_SIDED|95.0|0.56|1.02|||Unstratified log-rank test|The p-value is based on an unstratified log-rank test.|Based on Cox proportional hazards model comparing the hazard functions associated with treatment groups|||1.02|0.56|0.064
71095567|NCT01778985|141699528|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||||||0.21
70974701|NCT03434379|141456089|SUPERIORITY||Odds Ratio (OR)|6.15|||<|0.0001|TWO_SIDED|95.0|2.99|12.66|||Cochran-Mantel-Haenszel|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||12.66|2.99|<0.0001
70974702|NCT03434379|141456090|SUPERIORITY||Hazard Ratio (HR)|0.23||||0.0051|TWO_SIDED|95.0|0.08|0.7|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.70|0.08|0.0051
70974703|NCT03434379|141456091|SUPERIORITY||Hazard Ratio (HR)|0.3||||0.0048|TWO_SIDED|95.0|0.12|0.73|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.73|0.12|0.0048
70974704|NCT03434379|141456092|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.4187|TWO_SIDED|95.0|0.16|2.15|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||2.15|0.16|0.4187
70974705|NCT03434379|141456093|SUPERIORITY||Hazard Ratio (HR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.46|0.74|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.74|0.46|<.0001
70974706|NCT03434379|141456094|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.36|0.57|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.57|0.36|<.0001
70974707|NCT03434379|141456095|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0105|TWO_SIDED|95.0|0.53|0.92|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.92|0.53|0.0105
70974708|NCT03434379|141456096|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0063|TWO_SIDED|95.0|0.52|0.9|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.90|0.52|0.0063
70974709|NCT03434379|141456097|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.35|0.57|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.57|0.35|<.0001
70974710|NCT03434379|141456098|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.0019|TWO_SIDED|95.0|0.32|0.78|||Log Rank|||AFP \<400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).||0.78|0.32|0.0019
70974711|NCT03434379|141456098|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.0879|TWO_SIDED|95.0|0.42|1.06|||Log Rank|||AFP \>/= 400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).||1.06|0.42|0.0879
70974712|NCT03434379|141456099|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.37|0.68|||Log Rank|||AFP\<400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).||0.68|0.37|<.0001
70974713|NCT03434379|141456099|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.2159|TWO_SIDED|95.0|0.53|1.15|||Log Rank|||AFP \>/=400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).||1.15|0.53|0.2159
70974714|NCT03434379|141456100|SUPERIORITY||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.31|0.57|||Log Rank|||AFP \<400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).||0.57|0.31|<0.0001
70974715|NCT03434379|141456100|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.0002|TWO_SIDED|95.0|0.35|0.73|||Log Rank|||AFP \>/=400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).||0.73|0.35|0.0002
70974716|NCT03434379|141456101|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.39|0.73|||Log Rank|||Physical Functioning: Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.73|0.39|<.0001
70974717|NCT03434379|141456101|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.0019|TWO_SIDED|95.0|0.46|0.84|||Log Rank|||Role Functioning: Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.84|0.46|0.0019
70974718|NCT03434379|141456101|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0028|TWO_SIDED|95.0|0.46|0.85|||Log Rank|||GHS/QoL: Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.85|0.46|0.0028
70974719|NCT03434379|141456106|SUPERIORITY||Odds Ratio (OR)|4.6||||0.0036|TWO_SIDED|95.0|1.53|13.86|||Cochran-Mantel-Haenszel|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||13.86|1.53|0.0036
70974720|NCT03434379|141456107|SUPERIORITY||Odds Ratio (OR)|4.71||||0.0013|TWO_SIDED|95.0|1.72|12.87|||Cochran-Mantel-Haenszel|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||12.87|1.72|0.0013
70974721|NCT03434379|141456108|SUPERIORITY||Odds Ratio (OR)|5.05||||0.0052|TWO_SIDED|95.0|1.47|17.39|||Cochran-Mantel-Haenszel|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||17.39|1.47|0.0052
70974722|NCT03434379|141456109|SUPERIORITY||Hazard Ratio (HR)|0.37||||0.4581|TWO_SIDED|95.0|0.02|5.85|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||5.85|0.02|0.4581
70974723|NCT03434379|141456110|SUPERIORITY||Hazard Ratio (HR)|0.08||||0.01|TWO_SIDED|95.0|0.01|0.91|||Log Rank||Lower limit: \<0.01|Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.91|0.01|0.0100
71095568|NCT01778985|141699529|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||||||0.002
71095569|NCT01778985|141699530|SUPERIORITY_OR_OTHER|||||||0.22|||||||t-test, 2 sided|||||||0.22
71095570|NCT01778985|141699531|SUPERIORITY_OR_OTHER|||||||0.088|||||||t-test, 2 sided|t(18)=1.78, p=0.088||||||0.088
70974724|NCT03434379|141456111|SUPERIORITY||Hazard Ratio (HR)|0.33||||0.3477|TWO_SIDED|95.0|0.03|3.69|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||3.69|0.03|0.3477
70974725|NCT03434379|141456112|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.0103|TWO_SIDED|95.0|0.4|0.89|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.89|0.40|0.0103
70974726|NCT03434379|141456113|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.0002|TWO_SIDED|95.0|0.33|0.71|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.71|0.33|0.0002
70974727|NCT03434379|141456114|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0927|TWO_SIDED|95.0|0.43|1.07|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||1.07|0.43|0.0927
70974728|NCT03434379|141456115|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.0861|TWO_SIDED|95.0|0.43|1.06|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||1.06|0.43|0.0861
70974729|NCT03434379|141456116|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.0004|TWO_SIDED|95.0|0.33|0.74|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.74|0.33|0.0004
70974730|NCT03434379|141456117|SUPERIORITY||Hazard Ratio (HR)|0.45||||0.0035|TWO_SIDED|95.0|0.26|0.78|||Log Rank|||Physical Functioning: Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.78|0.26|0.0035
70974731|NCT03434379|141456117|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.2214|TWO_SIDED|95.0|0.42|1.23|||Log Rank|||Role Functioning: Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||1.23|0.42|0.2214
70974732|NCT03434379|141456117|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0135|TWO_SIDED|95.0|0.32|0.88|||Log Rank|||GHS/QoL: Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.88|0.32|0.0135
70974733|NCT00466310|141456130|SUPERIORITY_OR_OTHER|||||||0.0149|TWO_SIDED|95.0||||Unadjusted p value is .0041|Wilcoxon (Mann-Whitney)|||A wilcoxon rank sum test was performed comparing baseline plasmalogen values, comparing schizophrenia subjects vs controls.P values from this analysis were adjusted for false discovery rates by the method of Storey and Tribshiani.||||0.0149
70974734|NCT01634555|141456159|SUPERIORITY_OR_OTHER||Ratio of Geo LS means|0.93|||||TWO_SIDED|90.0|0.83|1.05|||Mixed Models Analysis|Ratio of Geo LS mean is AUC(0-∞) of Cycle 2/Cycle 1 for Irinotecan .||||1.05|0.83|
70974735|NCT01634555|141456159|SUPERIORITY_OR_OTHER||Ratio of Geo LS means|0.95|||||TWO_SIDED|90.0|0.88|1.04|||Mixed Models Analysis|Ratio of Geo LS mean is AUC(0-∞) of Cycle 2/Cycle 1 for Metabolite SN-38.||||1.04|0.88|
70974736|NCT01634555|141456161|SUPERIORITY_OR_OTHER||Ratio of Geo LS means|1.04|||||TWO_SIDED|90.0|0.97|1.12|||Mixed Models Analysis|Ratio of Geo LS mean is Cmax of Cycle 2/Cycle 1 for Irinotecan.||||1.12|0.97|
70974737|NCT01634555|141456161|SUPERIORITY_OR_OTHER||Ratio of Geo LS means|0.97|||||TWO_SIDED|90.0|0.85|1.12|||Mixed Models Analysis|Ratio of Geo LS mean is Cmax of Cycle 2/Cycle 1 for Metabolite SN-38.||||1.12|0.85|
70974738|NCT01299766|141456209|SUPERIORITY||Risk Ratio (RR)|0.12||||0.02|TWO_SIDED|95.0|0.02|0.74|||Poisson regression with robust SE (GEE)|||Poisson regression with robust standard errors (GEE) was used to jointly model decline in HVLT-R Total Recall score ≥ 6 words at 6, 12, 18, and 24 months by treatment group. The model included time, treatment, time-by-treatment interaction terms, and baseline HVLT-R Total Recall score.||0.74|0.02|.02
70974739|NCT01299766|141456210|SUPERIORITY||Difference in Slopes|2.47||||0.064|TWO_SIDED|95.0|-0.14|5.07|||Mixed Models Analysis|||Mixed effects linear regression was used to model the trajectory. Fixed effects for time (as a continuous variable), treatment group, time-by-treatment group interaction, and age at baseline were included. Random intercepts and slopes were included to account for within-subject correlation.||5.07|-.14|.064
71008438|NCT00792922|141524771|SUPERIORITY|For each community using the baseline observed prevalence, treatment arm and parameters estimated from square root transformed model we estimated predicted prevalence.For each arm we average estimated prevalences.The difference in the adjusted mean prevalence for enhanced arm and standard arm was then calculated.In order to derive the confidence intervals for the adjusted difference, we repeated Steps 1 to 4 for 1000 bootstrap samples.The median of the adjusted mean differences were reported.|Mean Difference (Final Values)|2.6||||0.73|TWO_SIDED|95.0|-0.3|5.3|||Ordinary least squares linear regression|||"This is the analysis done in Tanzania:~Only the main effect of coverage was analyzed.We hypothesized that increasing the coverage of MDA to greater than 90 % as monitored in children would result in more rapid decline in infection and trachoma compared to usual coverage.~Here we are looking at the prevalence of trachoma"||5.3|-0.3|0.73
71095571|NCT01778985|141699532|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71095572|NCT01778985|141699533|SUPERIORITY_OR_OTHER|||||||0.91||||||t(28)=0.11, p=0.91|t-test, 2 sided|||||||0.91
71095573|NCT01778985|141699534|SUPERIORITY_OR_OTHER|||||||0.1||||||t(18)=1.69, p=.10|t-test, 2 sided|||||||0.10
71095574|NCT01778985|141699535|SUPERIORITY_OR_OTHER|||||||0.02||||||t(10)=2.76, p=0.020|t-test, 2 sided|||||||0.020
71095575|NCT01778985|141699536|SUPERIORITY_OR_OTHER|||||||0.78||||||t(23)=0.28, p=0.78|t-test, 2 sided|||||||0.78
71095576|NCT01778985|141699537|SUPERIORITY_OR_OTHER|||||||0.51||||||t(28)=0.67, p=0.51|t-test, 2 sided|||||||0.51
71095577|NCT01778985|141699538|SUPERIORITY_OR_OTHER|||||||0.24||||||t(23)=1.23, p=0.24|t-test, 2 sided|||||||0.24
71095578|NCT01778985|141699539|SUPERIORITY_OR_OTHER|||||||0.53|||||||t-test, 2 sided|||||||0.53
71095579|NCT01778985|141699540|SUPERIORITY_OR_OTHER|||||||0.33|||||||t-test, 2 sided|||||||0.33
71095580|NCT01778985|141699541|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71095581|NCT01778985|141699542|SUPERIORITY_OR_OTHER|||||||0.15|||||||t-test, 2 sided|||||||0.15
71033700|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81|||<|0.001|TWO_SIDED|95.0|0.41|1.22||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||1.22|0.41|<0.001
71033701|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61||||0.003|TWO_SIDED|95.0|0.22|1.01||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||1.01|0.22|0.003
71033702|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.004|TWO_SIDED|95.0|0.19|0.98||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||0.98|0.19|0.004
71033703|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.41|||<|0.001|TWO_SIDED|95.0|0.91|1.91||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||1.91|0.91|<0.001
71033704|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24|||<|0.001|TWO_SIDED|95.0|0.75|1.74||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||1.74|0.75|<0.001
71033705|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|||<|0.001|TWO_SIDED|95.0|0.41|1.39||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||1.39|0.41|<0.001
71033706|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63|||<|0.001|TWO_SIDED|95.0|1.11|2.16||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||2.16|1.11|<0.001
71033707|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.57|||<|0.001|TWO_SIDED|95.0|1.05|2.09||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||2.09|1.05|<0.001
71033708|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|||<|0.001|TWO_SIDED|95.0|0.75|1.78||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||1.78|0.75|<0.001
71033709|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.99|||<|0.001|TWO_SIDED|95.0|1.46|2.52||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||2.52|1.46|<0.001
71033710|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.09|||<|0.001|TWO_SIDED|95.0|1.57|2.61||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||2.61|1.57|<0.001
71033711|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68|||<|0.001|TWO_SIDED|95.0|1.16|2.2||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||2.20|1.16|<0.001
71033712|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.12|||<|0.001|TWO_SIDED|95.0|1.59|2.64||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||2.64|1.59|<0.001
71033713|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22|||<|0.001|TWO_SIDED|95.0|1.7|2.74||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||2.74|1.70|<0.001
71033714|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.69|||<|0.001|TWO_SIDED|95.0|1.18|2.21||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||2.21|1.18|<0.001
71033715|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||<|0.001|TWO_SIDED|95.0|1.98|3.01||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||3.01|1.98|<0.001
71033716|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.48|||<|0.001|TWO_SIDED|95.0|1.97|2.99||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||2.99|1.97|<0.001
71033717|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.88|||<|0.001|TWO_SIDED|95.0|1.37|2.38||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||2.38|1.37|<0.001
71033718|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.54|||<|0.001|TWO_SIDED|95.0|2.01|3.07||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||3.07|2.01|<0.001
71033719|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.45|||<|0.001|TWO_SIDED|95.0|1.92|2.97||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||2.97|1.92|<0.001
71033720|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81|||<|0.001|TWO_SIDED|95.0|1.29|2.33||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||2.33|1.29|<0.001
71033721|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.47|||<|0.001|TWO_SIDED|95.0|1.92|3.03||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||3.03|1.92|<0.001
71033722|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.41|||<|0.001|TWO_SIDED|95.0|1.87|2.96||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||2.96|1.87|<0.001
71033723|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.71|||<|0.001|TWO_SIDED|95.0|1.16|2.25||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||2.25|1.16|<0.001
71033724|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.26|||<|0.001|TWO_SIDED|95.0|1.69|2.83||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||2.83|1.69|<0.001
71033725|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.37|||<|0.001|TWO_SIDED|95.0|1.8|2.93||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||2.93|1.80|<0.001
71033726|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67|||<|0.001|TWO_SIDED|95.0|1.11|2.23||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||2.23|1.11|<0.001
71033727|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22|||<|0.001|TWO_SIDED|95.0|1.66|2.79||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||2.79|1.66|<0.001
71033728|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|||<|0.001|TWO_SIDED|95.0|1.74|2.85||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||2.85|1.74|<0.001
71033729|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.57|||<|0.001|TWO_SIDED|95.0|1.02|2.13||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||2.13|1.02|<0.001
71033730|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.19|||<|0.001|TWO_SIDED|95.0|1.59|2.78||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||2.78|1.59|<0.001
71033731|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.12|||<|0.001|TWO_SIDED|95.0|1.53|2.7||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||2.70|1.53|<0.001
71033732|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63|||<|0.001|TWO_SIDED|95.0|1.04|2.21||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||2.21|1.04|<0.001
71095582|NCT01778985|141699543|SUPERIORITY_OR_OTHER|||||||0.82|||||||t-test, 2 sided|||||||0.82
70974740|NCT00403260|141456219|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The primary efficacy analysis tested the non-inferiority of the PA group compared to the comparator group with regard to the PCR-corrected ACPR response rate at Day 28 using the 2-sided 95% confidence interval (CI) (Newcombe-Wilson score method without continuity correction). Non-inferiority of PA to MQ + AS was concluded if the lower limit of the CI for the difference was \>-5%.|ACPR percent difference|1.1||||0.106|TWO_SIDED|95.0|-0.2|3.1||If non-inferiority of PA was demonstrated, the p-value associated with a superiority test is calculated based on a 2-sided Chi-square test. If the calculated p-value is \<5%, then the superiority of PA compared to MQ+AS was statistically demonstrated.|Chi-squared|||"Null hypothesis: The PCR-corrected ACPR response rate at Day 28 for the PA group is inferior to the PCR-corrected ACPR response rate at Day 28 for the comparator group (MQ + AS) by more than 5%.~Was tested versus the alternative:~Alternative hypothesis: the PCR-corrected ACPR response rate at Day 28 for the PA group is not inferior to the PCR-corrected ACPR response rate at Day 28 for the comparator group (MQ + AS) by more than -5%."||3.1|-0.2|0.106
70974741|NCT01354028|141456227|SUPERIORITY_OR_OTHER|||||||0.1303||95.0|||||Chi-squared|Degrees of freedom =1||"Null hypothesis: there will be no difference in sleep efficiency in preterm infants on the day of massage versus the day without massage.~Power calculation: the sample size was determined by convenience for this pilot study"||||0.1303
70974742|NCT01354028|141456230|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||Pearson's chi square|Chi-squared|Degrees of freedom=1||"Null hypothesis: there is no difference in massage therapy or no massage therapy in number of infants who will be asleep at the end of massage or the corresponding time frame on the non massage day.~Pearson's chi square=4.98"||||0.026
70974743|NCT02109159|141456231|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.44|TWO_SIDED|95.0|0.8|1.4|||Chi-squared||This analysis was conducted on an intention-to-treat (ITT) basis including all participants randomised.|||1.4|0.8|0.44
70974744|NCT02109159|141456231|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.47|TWO_SIDED|95.0|0.8|1.7|||Chi-squared||This analysis was conducted on a per-protocol (PP) basis including only those who watched the videos.|||1.7|0.8|0.47
70974745|NCT02109159|141456232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.53|TWO_SIDED|95.0|-0.02|0.04|||t-test, 2 sided||This analysis was conducted on an intention-to-treat (ITT) basis including all participants randomised.|||0.04|-0.02|0.53
70974746|NCT02109159|141456232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.56|TWO_SIDED|95.0|-0.5|0.8|||t-test, 2 sided||This analysis was conducted on a per-protocol (PP) basis including only those who watched the videos.|||0.8|-0.5|0.56
70974747|NCT03195517|141456237|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
70974748|NCT03195517|141456238|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
70974749|NCT03195517|141456239|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
70974750|NCT03195517|141456240|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
70974751|NCT03195517|141456241|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
70974752|NCT03195517|141456242|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
70974753|NCT03195517|141456243|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
70974754|NCT03195517|141456244|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
70974755|NCT03195517|141456245|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
70974756|NCT03195517|141456246|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
70974757|NCT01846455|141456247|SUPERIORITY_OR_OTHER||ratio of parameter means, %|99.34|||||TWO_SIDED|90.0|66.05|149.43||||||Buprenorphine||149.43|66.05|
70974758|NCT01846455|141456247|SUPERIORITY_OR_OTHER||ratio of parameter means, %|163.88|||||TWO_SIDED|90.0|110.82|242.34||||||Buprenorphine||242.34|110.82|
70974759|NCT01846455|141456247|SUPERIORITY_OR_OTHER||ratio of parameter means, %|281.43|||||TWO_SIDED|90.0|187.1|423.33||||||Buprenorphine||423.33|187.10|
70974760|NCT01846455|141456247|SUPERIORITY_OR_OTHER||ratio of parameter means, %|78.43|||||TWO_SIDED|90.0|52.14|117.98||||||Buprenorphine||117.98|52.14|
70974761|NCT01846455|141456247|SUPERIORITY_OR_OTHER||ratio of parameter means, %|126.66|||||TWO_SIDED|90.0|81.87|195.97||||||Buprenorphine||195.97|81.87|
70974762|NCT01846455|141456247|SUPERIORITY_OR_OTHER||ratio of parameter means, %|208.94|||||TWO_SIDED|90.0|137.21|318.18||||||Buprenorphine||318.18|137.21|
70974763|NCT01846455|141456247|SUPERIORITY_OR_OTHER||ratio of parameter means, %|358.83|||||TWO_SIDED|90.0|231.92|555.17||||||Buprenorphine||555.17|231.92|
70974764|NCT01846455|141456247|SUPERIORITY_OR_OTHER||ratio of parameter means, %|78.09|||||TWO_SIDED|90.0|44.03|138.49||||||Norbuprenorphine||138.49|44.03|
70974765|NCT01846455|141456247|SUPERIORITY_OR_OTHER||ratio of parameter means, %|74.78|||||TWO_SIDED|90.0|39.26|142.41||||||Norbuprenorphine||142.41|39.26|
70974766|NCT01846455|141456247|SUPERIORITY_OR_OTHER||ratio of parameter means, %|11.45|||||TWO_SIDED|90.0|6.35|20.66||||||Norbuprenorphine||20.66|6.35|
70974767|NCT01846455|141456247|SUPERIORITY_OR_OTHER||ratio of parameter means, %|71.08|||||TWO_SIDED|90.0|39.0|129.49||||||Norbuprenorphine||129.49|39.00|
70974768|NCT01846455|141456247|SUPERIORITY_OR_OTHER||ratio of parameter means, %|109.9|||||TWO_SIDED|90.0|58.14|207.75||||||Norbuprenorphine||207.75|58.14|
70974769|NCT01846455|141456247|SUPERIORITY_OR_OTHER||ratio of parameter means, %|105.23|||||TWO_SIDED|90.0|52.17|212.24||||||Norbuprenorphine||212.24|52.17|
70974770|NCT01846455|141456247|SUPERIORITY_OR_OTHER||ratio of parameter means, %|16.12|||||TWO_SIDED|90.0|8.4|30.94||||||Norbuprenorphine||30.94|8.40|
70974771|NCT01846455|141456247|SUPERIORITY_OR_OTHER||ratio of parameter means, %|79.3|||||TWO_SIDED|90.0|40.03|157.12||||||Naloxone||157.12|40.03|
70974772|NCT01846455|141456247|SUPERIORITY_OR_OTHER||ratio of parameter means, %|317.58|||||TWO_SIDED|90.0|164.93|611.54||||||Naloxone||611.54|164.93|
70974773|NCT01846455|141456247|SUPERIORITY_OR_OTHER||ratio of parameter means, %|1401.85|||||TWO_SIDED|90.0|707.55|2777.46||||||Naloxone||2777.46|707.55|
71095583|NCT01778985|141699544|SUPERIORITY_OR_OTHER|||||||0.7|||||||t-test, 2 sided|||||||0.70
71095584|NCT01778985|141699545|SUPERIORITY_OR_OTHER|||||||0.25|||||||t-test, 2 sided|||||||0.25
71095585|NCT01778985|141699546|SUPERIORITY_OR_OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.06
71095586|NCT01778985|141699547|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||||||1
71095587|NCT01363440|141699603|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.19|||<|0.0001|TWO_SIDED|97.5|9.35|15.04|||ANCOVA|||||15.04|9.35|<.0001
71095588|NCT01363440|141699603|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.45|||<|0.0001|TWO_SIDED|97.5|7.73|13.17|||ANCOVA|||||13.17|7.73|<.0001
71095589|NCT01363440|141699604|SUPERIORITY_OR_OTHER||Mean Difference (Net)|45.9||||0.0001|TWO_SIDED|97.5|34.7|57.0|||Cochran-Mantel-Haenszel|||||57.0|34.7|.0001
71095590|NCT01363440|141699604|SUPERIORITY_OR_OTHER||Mean Difference (Net)|38.8||||0.0001|TWO_SIDED|97.5|27.2|50.3|||Cochran-Mantel-Haenszel|||||50.3|27.2|.0001
71095591|NCT01363440|141699605|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.2|||<|0.0001|TWO_SIDED|97.5|24.1|44.4|||Cochran-Mantel-Haenszel|||||44.4|24.1|<0.0001
71095592|NCT01363440|141699605|SUPERIORITY_OR_OTHER||Mean Difference (Net)|23.3|||<|0.0001|TWO_SIDED|97.5|13.5|33.1|||Cochran-Mantel-Haenszel|||||33.1|13.5|<.0001
71095593|NCT01363440|141699606|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.7|||<|0.0001|TWO_SIDED|97.5|9.0|30.4|||Cochran-Mantel-Haenszel|||||30.4|9.0|<.0001
71095594|NCT01363440|141699606|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.9||||0.0017|TWO_SIDED|97.5|4.4|25.4|||Cochran-Mantel-Haenszel|||||25.4|4.4|0.0017
71095595|NCT01363440|141699607|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-110.8|||<|0.0001|TWO_SIDED|97.5|-141.3|-80.22|||ANCOVA|||||-80.22|-141.3|<.0001
71095596|NCT01363440|141699607|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-113.5|||<|0.0001|TWO_SIDED|97.5|-144.2|-82.75|||ANCOVA|||||-82.75|-144.2|<.0001
71095597|NCT01363440|141699608|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.19||||0.0168||97.5|0.33|10.04|||ANCOVA|||||10.04|0.33|0.0168
71095598|NCT01363440|141699608|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.36||||0.0323|TWO_SIDED|97.5|-0.21|8.93|||ANCOVA|||||8.93|-0.21|0.0323
71095599|NCT01363440|141699609|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.86||||0.1702|TWO_SIDED|97.5|-1.82|7.54|||ANCOVA|||||7.54|-1.82|0.1702
71095600|NCT01363440|141699609|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.65||||0.4067|TWO_SIDED|97.5|-2.83|6.13|||ANCOVA|||||6.13|-2.83|0.4067
71095601|NCT01625182|141699623|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9838|TWO_SIDED|95.0|0.6|1.7|||Regression, Cox|||||1.7|0.6|0.9838
71095602|NCT00447278|141699629|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.36|||<|0.001|TWO_SIDED|95.0|-6.47|-2.25||P-value for Change from Baseline at 6 Months. P-value is not adjusted and the threshold is 0.05.|Mixed Models Analysis|Mixed model repeated measure analysis with terms for corresponding baseline T-score, treatment, country, visit, and treatment-by-visit interaction.|Least Squares Mean Difference = Atomoxetine minus OEST.|||-2.25|-6.47|<0.001
71095603|NCT00447278|141699629|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.6|||<|0.001|TWO_SIDED|95.0|-6.56|-2.63||P-value for Change from Baseline: 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-2.63|-6.56|<0.001
71095604|NCT00447278|141699630|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.1||||0.002|TWO_SIDED|95.0|-5.08|-1.13||P-value for Change from Baseline: 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-1.13|-5.08|0.002
71095605|NCT00447278|141699631|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.04||||0.002|TWO_SIDED|95.0|-4.92|-1.15||P-value for Comfort Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-1.15|-4.92|0.002
71095606|NCT00447278|141699631|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.1||||0.031|TWO_SIDED|95.0|-4.01|-0.2||P-value for Comfort Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.20|-4.01|0.031
71095607|NCT00447278|141699631|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.55||||0.629|TWO_SIDED|95.0|-1.68|2.77||P-value for Resilience Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||2.77|-1.68|0.629
71095608|NCT00447278|141699631|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.96||||0.421|TWO_SIDED|95.0|-3.3|1.38||P-value for Resilience Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||1.38|-3.30|0.421
71095609|NCT00447278|141699631|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.05||||0.388|TWO_SIDED|95.0|-3.44|1.34||P-value for Risk Avoidance Change: 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||1.34|-3.44|0.388
71095610|NCT00447278|141699631|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.29||||0.059|TWO_SIDED|95.0|-4.66|0.09||P-value for Risk Avoidance Change: 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.09|-4.66|0.059
71095611|NCT00447278|141699631|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.56||||0.006|TWO_SIDED|95.0|-6.09|-1.04||P-value for Satisfaction Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-1.04|-6.09|0.006
71095612|NCT00447278|141699631|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.91||||0.027|TWO_SIDED|95.0|-5.49|-0.33||P-value for Satisfaction Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.33|-5.49|0.027
71095613|NCT00447278|141699632|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.073||||0.015|TWO_SIDED|95.0|0.014|0.131||P-value for Total Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.131|0.014|0.015
71095614|NCT00447278|141699632|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.085||||0.004|TWO_SIDED|95.0|0.027|0.143||P-value for Total Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.143|0.027|0.004
71095615|NCT00447278|141699632|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.094||||0.063|TWO_SIDED|95.0|-0.005|0.192||P-value for Home Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.192|-0.005|0.063
71095616|NCT00447278|141699632|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.075||||0.131|TWO_SIDED|95.0|-0.022|0.172||P-value for Home Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.172|-0.022|0.131
71095617|NCT00447278|141699632|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.052||||0.156|TWO_SIDED|95.0|-0.02|0.124||P-value for Daily Living Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.124|-0.020|0.156
71095618|NCT00447278|141699632|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.072||||0.046|TWO_SIDED|95.0|0.001|0.143||P-value for Daily Living Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.143|0.001|0.046
71095619|NCT00447278|141699632|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.04||||0.068|TWO_SIDED|95.0|-0.003|0.084||P-value for Risk Taking Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.084|-0.003|0.068
70974774|NCT01846455|141456247|SUPERIORITY_OR_OTHER||ratio of parameter means, %|105.78|||||TWO_SIDED|90.0|53.39|209.59||||||Naloxone||209.59|53.39|
70974775|NCT01846455|141456247|SUPERIORITY_OR_OTHER||ratio of parameter means, %|74.97|||||TWO_SIDED|90.0|36.09|155.71||||||Naloxone||155.71|36.09|
70974776|NCT01846455|141456247|SUPERIORITY_OR_OTHER||ratio of parameter means, %|300.22|||||TWO_SIDED|90.0|148.44|607.21||||||Naloxone||607.21|148.44|
70974777|NCT01846455|141456247|SUPERIORITY_OR_OTHER||ratio of parameter means, %|1325.22|||||TWO_SIDED|90.0|638.03|2752.55||||||Naloxone||2752.55|638.03|
70974778|NCT01846455|141456247|SUPERIORITY_OR_OTHER||ratio of parameter means, %|85.87|||||TWO_SIDED|90.0|66.06|111.61||||||Naloxone-3-β-D-Glucuronide||111.61|66.06|
70974779|NCT01846455|141456247|SUPERIORITY_OR_OTHER||ratio of parameter means, %|123.77|||||TWO_SIDED|90.0|96.27|159.13||||||Naloxone-3-β-D-Glucuronide||159.13|96.27|
70974780|NCT01846455|141456247|SUPERIORITY_OR_OTHER||ratio of parameter means, %|91.26|||||TWO_SIDED|90.0|70.21|118.62||||||Naloxone-3-β-D-Glucuronide||118.62|70.21|
70974781|NCT01846455|141456247|SUPERIORITY_OR_OTHER||ratio of parameter means, %|84.78|||||TWO_SIDED|90.0|65.23|110.2||||||Naloxone-3-β-D-Glucuronide||110.20|65.23|
70974782|NCT01846455|141456247|SUPERIORITY_OR_OTHER||ratio of parameter means, %|101.28|||||TWO_SIDED|90.0|76.52|134.06||||||Naloxone-3-β-D-Glucuronide||134.06|76.52|
70974783|NCT01846455|141456247|SUPERIORITY_OR_OTHER||ratio of parameter means, %|145.99|||||TWO_SIDED|90.0|111.43|191.26||||||Naloxone-3-β-D-Glucuronide||191.26|111.43|
70974784|NCT01846455|141456247|SUPERIORITY_OR_OTHER||ratio of parameter means, %|107.64|||||TWO_SIDED|90.0|81.33|142.47||||||Naloxone-3-β-D-Glucuronide||142.47|81.33|
70974785|NCT01846455|141456248|SUPERIORITY_OR_OTHER||ratio of parameter means, %|120.02|||||TWO_SIDED|90.0|83.35|172.82||||||Buprenorphine||172.82|83.35|
70974786|NCT01846455|141456248|SUPERIORITY_OR_OTHER||ratio of parameter means, %|107.85|||||TWO_SIDED|90.0|75.85|153.36||||||Buprenorphine||153.36|75.85|
70974787|NCT01846455|141456248|SUPERIORITY_OR_OTHER||ratio of parameter means, %|171.76|||||TWO_SIDED|90.0|117.93|250.15||||||Buprenorphine||250.15|117.93|
70974788|NCT01846455|141456248|SUPERIORITY_OR_OTHER||ratio of parameter means, %|112.82|||||TWO_SIDED|90.0|77.66|163.91||||||Buprenorphine||163.91|77.66|
70974789|NCT01846455|141456248|SUPERIORITY_OR_OTHER||ratio of parameter means, %|106.38|||||TWO_SIDED|90.0|71.43|158.43||||||Buprenorphine||158.43|71.43|
70974790|NCT01846455|141456248|SUPERIORITY_OR_OTHER||ratio of parameter means, %|95.59|||||TWO_SIDED|90.0|64.36|141.99||||||Buprenorphine||141.99|64.36|
70974791|NCT01846455|141456248|SUPERIORITY_OR_OTHER||ratio of parameter means, %|152.24|||||TWO_SIDED|90.0|103.08|224.83||||||Buprenorphine||224.83|103.08|
70974792|NCT01846455|141456248|SUPERIORITY_OR_OTHER||ratio of parameter means, %|135.17|||||TWO_SIDED|90.0|75.44|242.16||||||Norbuprenorphine||242.16|75.44|
70974793|NCT01846455|141456248|SUPERIORITY_OR_OTHER||ratio of parameter means, %|67.87|||||TWO_SIDED|90.0|38.82|118.68||||||Norbuprenorphine||118.68|38.82|
70974794|NCT01846455|141456248|SUPERIORITY_OR_OTHER||ratio of parameter means, %|48.39|||||TWO_SIDED|90.0|27.01|86.69||||||Norbuprenorphine||86.69|27.01|
70974795|NCT01846455|141456248|SUPERIORITY_OR_OTHER||ratio of parameter means, %|76.59|||||TWO_SIDED|90.0|42.75|137.22||||||Norbuprenorphine||137.22|42.75|
70974796|NCT01846455|141456248|SUPERIORITY_OR_OTHER||ratio of parameter means, %|176.48|||||TWO_SIDED|90.0|94.62|329.17||||||Norbuprenorphine||329.17|94.62|
70974797|NCT01846455|141456248|SUPERIORITY_OR_OTHER||ratio of parameter means, %|88.62|||||TWO_SIDED|90.0|48.6|161.59||||||Norbuprenorphine||161.59|48.60|
70974798|NCT01846455|141456248|SUPERIORITY_OR_OTHER||ratio of parameter means, %|63.17|||||TWO_SIDED|90.0|33.87|117.83||||||Norbuprenorphine||117.83|33.87|
70974799|NCT01846455|141456248|SUPERIORITY_OR_OTHER||ratio of parameter means, %|100.41|||||TWO_SIDED|90.0|51.3|196.53||||||Naloxone||196.53|51.30|
70974800|NCT01846455|141456248|SUPERIORITY_OR_OTHER||ratio of parameter means, %|270.0|||||TWO_SIDED|90.0|141.86|513.9||||||Naloxone||513.90|141.86|
70974801|NCT01846455|141456248|SUPERIORITY_OR_OTHER||ratio of parameter means, %|1129.81|||||TWO_SIDED|90.0|577.22|2211.44||||||Naloxone||2211.44|577.22|
70974802|NCT01846455|141456248|SUPERIORITY_OR_OTHER||ratio of parameter means, %|126.25|||||TWO_SIDED|90.0|64.5|247.11||||||Naloxone||247.11|64.50|
70974803|NCT01846455|141456248|SUPERIORITY_OR_OTHER||ratio of parameter means, %|79.53|||||TWO_SIDED|90.0|38.79|163.06||||||Naloxone||163.06|38.79|
70974804|NCT01846455|141456248|SUPERIORITY_OR_OTHER||ratio of parameter means, %|213.86|||||TWO_SIDED|90.0|107.07|427.17||||||Naloxone||427.17|107.07|
70974805|NCT01846455|141456248|SUPERIORITY_OR_OTHER||ratio of parameter means, %|894.91|||||TWO_SIDED|90.0|436.49|1834.8||||||Naloxone||1834.80|436.49|
70974806|NCT01846455|141456248|SUPERIORITY_OR_OTHER||ratio of parameter means, %|111.03|||||TWO_SIDED|90.0|85.94|143.44||||||Naloxone-3-β-D-Glucuronide||143.44|85.94|
70974807|NCT01846455|141456248|SUPERIORITY_OR_OTHER||ratio of parameter means, %|111.22|||||TWO_SIDED|90.0|87.02|142.16||||||Naloxone-3-β-D-Glucuronide||142.16|87.02|
70974808|NCT01846455|141456248|SUPERIORITY_OR_OTHER||ratio of parameter means, %|83.09|||||TWO_SIDED|90.0|64.32|107.35||||||Naloxone-3-β-D-Glucuronide||107.35|64.32|
70974809|NCT01846455|141456248|SUPERIORITY_OR_OTHER||ratio of parameter means, %|83.66|||||TWO_SIDED|90.0|64.75|108.08||||||Naloxone-3-β-D-Glucuronide||108.08|64.75|
70974810|NCT01846455|141456248|SUPERIORITY_OR_OTHER||ratio of parameter means, %|132.72|||||TWO_SIDED|90.0|100.93|174.53||||||Naloxone-3-β-D-Glucuronide||174.53|100.93|
70974811|NCT01846455|141456248|SUPERIORITY_OR_OTHER||ratio of parameter means, %|132.95|||||TWO_SIDED|90.0|102.12|173.1||||||Naloxone-3-β-D-Glucuronide||173.10|102.12|
70974812|NCT01846455|141456248|SUPERIORITY_OR_OTHER||ratio of parameter means, %|99.33|||||TWO_SIDED|90.0|75.54|130.61||||||Naloxone-3-β-D-Glucuronide||130.61|75.54|
70974813|NCT01846455|141456249|SUPERIORITY_OR_OTHER||ratio of parameter means, %|125.19|||||TWO_SIDED|90.0|79.46|197.24||||||Buprenorphine||197.24|79.46|
70974814|NCT01846455|141456249|SUPERIORITY_OR_OTHER||ratio of parameter means, %|220.97|||||TWO_SIDED|90.0|135.33|360.81||||||Buprenorphine||360.81|135.33|
70974815|NCT01846455|141456249|SUPERIORITY_OR_OTHER||ratio of parameter means, %|249.28|||||TWO_SIDED|90.0|162.19|383.14||||||Buprenorphine||383.14|162.19|
70974816|NCT01846455|141456249|SUPERIORITY_OR_OTHER||ratio of parameter means, %|94.44|||||TWO_SIDED|90.0|56.44|158.02||||||Buprenorphine||158.02|56.44|
70974817|NCT01846455|141456249|SUPERIORITY_OR_OTHER||ratio of parameter means, %|132.57|||||TWO_SIDED|90.0|78.86|222.84||||||Buprenorphine||222.84|78.86|
70974818|NCT01846455|141456249|SUPERIORITY_OR_OTHER||ratio of parameter means, %|233.99|||||TWO_SIDED|90.0|135.63|403.68||||||Buprenorphine||403.68|135.63|
70974819|NCT01846455|141456249|SUPERIORITY_OR_OTHER||ratio of parameter means, %|263.97|||||TWO_SIDED|90.0|155.52|448.03||||||Buprenorphine||448.03|155.52|
70974820|NCT01846455|141456249|SUPERIORITY_OR_OTHER||ratio of parameter means, %|159.38|||||TWO_SIDED|90.0|78.21|324.79||||||Norbuprenorphine||324.79|78.21|
70974821|NCT01846455|141456249|SUPERIORITY_OR_OTHER||ratio of parameter means, %|106.93|||||TWO_SIDED|90.0|52.47|217.91||||||Norbuprenorphine||217.91|52.47|
70974822|NCT01846455|141456249|SUPERIORITY_OR_OTHER||ratio of parameter means, %|87.1|||||TWO_SIDED|90.0|42.74|177.5||||||Norbuprenorphine||177.50|42.74|
70974823|NCT01846455|141456249|SUPERIORITY_OR_OTHER||ratio of parameter means, %|182.98|||||TWO_SIDED|90.0|89.79|372.89||||||Norbuprenorphine||372.89|89.79|
70974824|NCT01846455|141456249|SUPERIORITY_OR_OTHER||ratio of parameter means, %|122.77|||||TWO_SIDED|90.0|60.24|250.19||||||Norbuprenorphine||250.19|60.24|
70974825|NCT01846455|141456249|SUPERIORITY_OR_OTHER||ratio of parameter means, %|69.12|||||TWO_SIDED|90.0|33.45|142.82||||||Naloxone||142.82|33.45|
71095620|NCT00447278|141699632|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.028||||0.212|TWO_SIDED|95.0|-0.016|0.073||P-value for Risk Taking Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.073|-0.016|0.212
71095621|NCT00447278|141699632|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.121||||0.006|TWO_SIDED|95.0|0.034|0.208||P-value for School Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.208|0.034|0.006
71095622|NCT00447278|141699632|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.15|||<|0.001|TWO_SIDED|95.0|0.064|0.236||P-value for School Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.236|0.064|<0.001
70974826|NCT01846455|141456249|SUPERIORITY_OR_OTHER||ratio of parameter means, %|282.17|||||TWO_SIDED|90.0|141.59|562.3||||||Naloxone||562.30|141.59|
70974827|NCT01846455|141456249|SUPERIORITY_OR_OTHER||ratio of parameter means, %|1497.7|||||TWO_SIDED|90.0|724.85|3094.59||||||Naloxone||3094.59|724.85|
70974828|NCT01846455|141456249|SUPERIORITY_OR_OTHER||ratio of parameter means, %|87.64|||||TWO_SIDED|90.0|40.3|190.59||||||Naloxone||190.59|40.30|
70974829|NCT01846455|141456249|SUPERIORITY_OR_OTHER||ratio of parameter means, %|78.86|||||TWO_SIDED|90.0|34.34|181.12||||||Naloxone||181.12|34.34|
70974830|NCT01846455|141456249|SUPERIORITY_OR_OTHER||ratio of parameter means, %|321.94|||||TWO_SIDED|90.0|144.65|716.52||||||Naloxone||716.52|144.65|
70974831|NCT01846455|141456249|SUPERIORITY_OR_OTHER||ratio of parameter means, %|1708.83|||||TWO_SIDED|90.0|744.08|3924.47||||||Naloxone||3924.47|744.08|
70974832|NCT01846455|141456249|SUPERIORITY_OR_OTHER||ratio of parameter means, %|84.2|||||TWO_SIDED|90.0|60.92|116.38||||||Naloxone-3-β-D-Glucuronide||116.38|60.92|
70974833|NCT01846455|141456249|SUPERIORITY_OR_OTHER||ratio of parameter means, %|110.98|||||TWO_SIDED|90.0|82.02|150.17||||||Naloxone-3-β-D-Glucuronide||150.17|82.02|
70974834|NCT01846455|141456249|SUPERIORITY_OR_OTHER||ratio of parameter means, %|81.97|||||TWO_SIDED|90.0|60.03|111.92||||||Naloxone-3-β-D-Glucuronide||111.92|60.03|
70974835|NCT01846455|141456249|SUPERIORITY_OR_OTHER||ratio of parameter means, %|82.78|||||TWO_SIDED|90.0|59.89|114.42||||||Naloxone-3-β-D-Glucuronide||114.42|59.89|
70974836|NCT01846455|141456249|SUPERIORITY_OR_OTHER||ratio of parameter means, %|101.71|||||TWO_SIDED|90.0|74.96|138.0||||||Naloxone-3-β-D-Glucuronide||138.00|74.96|
70974837|NCT01846455|141456249|SUPERIORITY_OR_OTHER||ratio of parameter means, %|134.06|||||TWO_SIDED|90.0|101.07|177.82||||||Naloxone-3-β-D-Glucuronide||177.82|101.07|
70974838|NCT01846455|141456249|SUPERIORITY_OR_OTHER||ratio of parameter means, %|99.02|||||TWO_SIDED|90.0|73.93|132.61||||||Naloxone-3-β-D-Glucuronide||132.61|73.93|
70974839|NCT03881007|141456260|SUPERIORITY||Incidence rate ratio|1.17||||0.359|TWO_SIDED|95.0|0.84|1.64|||Mixed Models Analysis|||||1.64|0.84|0.359
70974840|NCT03881007|141456261|SUPERIORITY||Incidence rate ratio|5.78||||0.024|TWO_SIDED|95.0|1.52|136.56|||Mixed Models Analysis|||||136.56|1.52|0.024
70974841|NCT03881007|141456262|SUPERIORITY||Incidence rate ratio|1.09||||0.774|TWO_SIDED|95.0|0.61|1.95|||Mixed Models Analysis|||||1.95|0.61|0.774
70974842|NCT03881007|141456263|SUPERIORITY||incidence rate ratio|0.59||||0.323|TWO_SIDED|95.0|0.2|1.63|||Mixed Models Analysis|||||1.63|0.2|0.323
70974843|NCT03881007|141456265|SUPERIORITY||Incidence rate ratio|1.21||||0.279|TWO_SIDED|95.0|0.86|1.72|||Mixed Models Analysis|||||1.72|0.86|0.279
70974844|NCT00997516|141456314|SUPERIORITY_OR_OTHER|||||||0.01||||||Significant at p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.01
70974845|NCT00997516|141456315|SUPERIORITY_OR_OTHER||||||<|0.01||||||Significant at p\<0.05|t-test, 2 sided|||||||<0.01
70974846|NCT00997516|141456324|SUPERIORITY_OR_OTHER|||||||0.86||||||Significant at p\<0.05|Wilcoxon (Mann-Whitney)|||Overall body satisfaction||||0.86
70974847|NCT00997516|141456324|SUPERIORITY_OR_OTHER|||||||0.18||||||Significant at p\<0.05|Wilcoxon (Mann-Whitney)|||Damage to body||||0.18
70974848|NCT00997516|141456324|SUPERIORITY_OR_OTHER|||||||0.04||||||Significant at p\<0.05|Wilcoxon (Mann-Whitney)|||Physical attractiveness||||0.04
70974849|NCT00997516|141456324|SUPERIORITY_OR_OTHER|||||||0.34||||||Significant at p\<0.05|Wilcoxon (Mann-Whitney)|||Masculinity/femininity||||0.34
70974850|NCT00997516|141456324|SUPERIORITY_OR_OTHER|||||||0.63||||||Significant at p\<0.05|Wilcoxon (Mann-Whitney)|||Looking at oneself naked||||0.63
70974851|NCT00997516|141456325|SUPERIORITY_OR_OTHER|||||||0.48||||||Significant at p\<0.05|t-test, 2 sided|||Cosmetic appearance of abdomen||||0.48
70974852|NCT00997516|141456325|SUPERIORITY_OR_OTHER|||||||0.09||||||Significant at p\<0.05|t-test, 2 sided|||Cosmetic appearance of scars||||0.09
70974853|NCT00997516|141456325|SUPERIORITY_OR_OTHER|||||||0.25||||||Significant at p\<0.05|t-test, 2 sided|||Satisfaction with scars||||0.25
70974854|NCT00997516|141456325|SUPERIORITY_OR_OTHER|||||||0.81||||||Significant at p\<0.05|t-test, 2 sided|||Discomfort of scars||||0.81
70974855|NCT00997516|141456325|SUPERIORITY_OR_OTHER||||||<|0.01||||||Significant at p\<0.05|t-test, 2 sided|||Overall impression of scars||||<0.01
70974856|NCT01970176|141456341|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
70974857|NCT01970176|141456342|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
70974858|NCT01970176|141456343|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
70974859|NCT01394705|141456359|SUPERIORITY|||||||0.65|||||||Fisher Exact|||||||.65
70974860|NCT01394705|141456359|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
70974861|NCT01394705|141456360|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
70974862|NCT04823949|141456414|OTHER||Risk Ratio (RR)|1.59|||<|0.001|TWO_SIDED|95.0|1.33|1.88|||Chi-squared|||||1.88|1.33|<0.001
70974863|NCT04823949|141456415|OTHER||Risk Ratio (RR)|1.35||||0.53|TWO_SIDED|95.0|0.52|3.49|||Fisher Exact|||||3.49|0.52|.530
70974864|NCT04823949|141456416|OTHER||Risk Ratio (RR)|2.53||||0.059|TWO_SIDED|95.0|0.92|6.9|||Fisher Exact|||||6.90|0.92|.059
70974865|NCT04823949|141456417|OTHER||Risk Ratio (RR)|0.84||||0.792|TWO_SIDED|95.0|0.23|3.04|||Fisher Exact|||||3.04|0.23|.792
70974866|NCT04823949|141456418|OTHER||Risk Ratio (RR)|1.11||||0.21|TWO_SIDED|95.0|0.94|1.31|||Chi-squared|||||1.31|0.94|.210
70974867|NCT00523991|141456434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||<|0.001||95.0|0.18|0.27||"There was only one primary endpoint and the p-value was not adjusted for multiple comparisons.~Mean Difference (Final Values) means difference in LS-Means"|ANCOVA|The analysis of covariance model included treatment, site, and trough forced expiratory volume in 1 second at baseline in the model.||||0.27|0.18|<0.001
70974868|NCT00523991|141456438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||<|0.001||95.0|0.09|0.18||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|Terms include treatment, site, and trough forced expiratory volume in 1 second at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.18|0.09|<0.001
70974869|NCT00523991|141456442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|||<|0.001||95.0|0.19|0.29||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|Terms include treatment, site, and peak forced expiratory volume in 1 second at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.29|0.19|<0.001
71033733|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.91|||<|0.001|TWO_SIDED|95.0|1.3|2.52||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||2.52|1.30|<0.001
70974870|NCT00523991|141456458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||<|0.001||95.0|0.09|0.18||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"Terms include treatment, site, and forced expiratory volume in 1 second at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.18|0.09|<0.001
70974871|NCT00523991|141456459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||<|0.001||95.0|0.16|0.25||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and forced expiratory volume in 1 second at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.25|0.16|<0.001
70974872|NCT00523991|141456460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||<|0.001||95.0|0.18|0.28||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and forced expiratory volume in 1 second at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium vesus placebo||0.28|0.18|<0.001
70974873|NCT00523991|141456461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|||<|0.001||95.0|0.2|0.29||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and forced expiratory volume in 1 second at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.29|0.20|<0.001
70974874|NCT00523991|141456462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||<|0.001||95.0|0.2|0.3||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and peak forced expiratory volume in 1 second at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.30|0.20|<0.001
70974875|NCT00523991|141456466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31|||<|0.001||95.0|0.24|0.38||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms include treatment, site, and forced vital capacity area under the curve at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.38|0.24|<0.001
70974876|NCT00523991|141456470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|||<|0.001||95.0|0.14|0.28||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and trough forced vital capacity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.28|0.14|<0.001
71008439|NCT00792922|141524771|SUPERIORITY||Median Difference (Final Values)|-4.6||||0.2|TWO_SIDED|95.0|-11.1|1.9|||Regression, Linear|||"This is the statistical analysis for Niger:~We hypothesized that increasing the coverage of MDA to greater than 90 % as monitored in children would result in more rapid decline in infection and trachoma compared to usual coverage.Here we are looking at the prevalence of infection."||1.9|-11.1|0.20
71008440|NCT00792922|141524771|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.6|TWO_SIDED|95.0|-7.7|12.5|||Regression, Linear|||"This is the statistical analysis for Niger:~We hypothesized that increasing the coverage of MDA to greater than 90 % as monitored in children would result in more rapid decline in infection and trachoma compared to usual coverage.Here we are looking at the prevalence of trachoma."||12.5|-7.7|0.60
71033734|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.12|||<|0.001|TWO_SIDED|95.0|1.52|2.72||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||2.72|1.52|<0.001
71033735|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51|||<|0.001|TWO_SIDED|95.0|0.91|2.11||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||2.11|0.91|<0.001
71033736|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.94|||<|0.001|TWO_SIDED|95.0|1.34|2.55||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||2.55|1.34|<0.001
70974877|NCT00523991|141456474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||<|0.001||95.0|0.24|0.42||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and peak forced vital capacity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.42|0.24|<0.001
70974878|NCT00523991|141456490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|||<|0.001||95.0|0.14|0.28||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms include treatment, site, and forced vital capacity at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.28|0.14|<0.001
70974879|NCT00523991|141456491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|||<|0.001||95.0|0.21|0.36||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and forced vital capacity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.36|0.21|<0.001
70974880|NCT00523991|141456492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||<|0.001||95.0|0.23|0.38||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms include treatment, site, and forced vital capacity at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.38|0.23|<0.001
70974881|NCT00523991|141456493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||<|0.001||95.0|0.25|0.4||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms include treatment, site, and forced vital capacity at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.40|0.25|<0.001
70974882|NCT00523991|141456494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|||<|0.001||95.0|0.26|0.45||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and forced vital capacity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.45|0.26|<0.001
70974883|NCT00523991|141456501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.927||95.0|-0.38|0.41||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and albuterol use at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.41|-0.38|0.927
70974884|NCT00523991|141456502|SUPERIORITY_OR_OTHER|||||||0.174||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.174
70974885|NCT00523991|141456503|SUPERIORITY_OR_OTHER|||||||0.186||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.186
70974886|NCT00523991|141456504|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.045
71095623|NCT00447278|141699632|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.125||||0.034|TWO_SIDED|95.0|0.009|0.24||P-value for Self-Concept Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.240|0.009|0.034
71095624|NCT00447278|141699632|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.119||||0.04|TWO_SIDED|95.0|0.005|0.233||P-value for Self-Concept Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.233|0.005|0.040
70974887|NCT00523991|141456505|SUPERIORITY_OR_OTHER|||||||0.223||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.223
70974888|NCT00523991|141456506|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.010
70974889|NCT00523991|141456507|SUPERIORITY_OR_OTHER|||||||0.086||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.086
70974890|NCT00523991|141456509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64||||0.729||95.0|-2.97|4.24||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo||4.24|-2.97|0.729
70974891|NCT00523991|141456510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.149||95.0|-5.9|0.9||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo||0.90|-5.90|0.149
70974892|NCT00523991|141456511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.763||95.0|-4.0|2.93||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||2.93|-4.00|0.763
70974893|NCT00523991|141456512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.85||||0.313||95.0|-5.45|1.75||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo||1.75|-5.45|0.313
70974894|NCT00523991|141456513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.682||95.0|-4.6|3.01||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo||3.01|-4.60|0.682
71008441|NCT02394028|141524816|SUPERIORITY||Difference in rate|1.1||||0.8508|TWO_SIDED|95.0|-10.85|12.56||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||12.56|-10.85|0.8508
71095625|NCT00447278|141699632|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.085||||0.042|TWO_SIDED|95.0|0.003|0.166||p-value for Social Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.166|0.003|0.042
70974895|NCT00523991|141456514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.76||||0.043||95.0|-7.39|-0.13||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo||-0.13|-7.39|0.043
70974896|NCT00523991|141456516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.823||95.0|-6.01|4.79||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||4.79|-6.01|0.823
70974897|NCT00523991|141456517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.767||95.0|-7.86|5.81||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||5.81|-7.86|0.767
71095626|NCT00447278|141699632|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.048||||0.271|TWO_SIDED|95.0|-0.038|0.134||P-value for Social Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.134|-0.038|0.271
70974898|NCT00523991|141456518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77||||0.754||95.0|-4.12|5.67||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||5.67|-4.12|0.754
70974899|NCT00523991|141456519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.995||95.0|-6.31|6.27||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||6.27|-6.31|0.995
70974900|NCT00523991|141456520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19||||0.72||95.0|-7.77|5.39||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||5.39|-7.77|0.720
70974901|NCT00523991|141456521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.88||||0.064||95.0|-12.1|0.35||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo||0.35|-12.10|0.064
70974902|NCT00523991|141456523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.718||95.0|-7.21|4.98||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||4.98|-7.21|0.718
70974903|NCT00523991|141456524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.912||95.0|-7.9|7.06||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||7.06|-7.90|0.912
70974904|NCT00523991|141456525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.79||||0.162||95.0|-1.55|9.13||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||9.13|-1.55|0.162
70974905|NCT00523991|141456526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.59||||0.471||95.0|-4.51|9.69||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||9.69|-4.51|0.471
70974906|NCT00523991|141456527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.961||95.0|-6.52|6.84||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||6.84|-6.52|0.961
70974907|NCT00523991|141456528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9||||0.158||95.0|-11.73|1.94||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||1.94|-11.73|0.158
70974908|NCT00523991|141456530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.74||||0.469||95.0|-3.01|6.49||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||6.49|-3.01|0.469
71008442|NCT02394028|141524816|SUPERIORITY||Difference in rate|3.8||||0.5235|TWO_SIDED|95.0|-8.3|15.27||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||15.27|-8.30|0.5235
71095627|NCT00447278|141699633|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.307||||0.034|TWO_SIDED|95.0|0.173|4.44||P-value for Total Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||4.440|0.173|0.034
71095628|NCT00447278|141699633|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.072||||0.005|TWO_SIDED|95.0|0.942|5.202||P-value for Total Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||5.202|0.942|0.005
70974909|NCT00523991|141456531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.79||||0.079||95.0|-0.68|12.26||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||12.26|-0.68|0.079
70974910|NCT00523991|141456532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1||||0.051||95.0|-0.02|8.23||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||8.23|-0.02|0.051
70974911|NCT00523991|141456533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.43||||0.075||95.0|-0.35|7.21||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||7.21|-0.35|0.075
70974912|NCT00523991|141456534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.306||95.0|-1.39|4.38||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms for treatment, site, and work productivity at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||4.38|-1.39|0.306
70974913|NCT00523991|141456535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33||||0.363||95.0|-7.39|2.73||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||2.73|-7.39|0.363
70974914|NCT00523991|141456537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.668||95.0|-0.03|0.02||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms for treatment, site, and logarithm of baseline value Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.02|-0.03|0.668
70974915|NCT00523991|141456538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.78||95.0|-0.02|0.03||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.03|-0.02|0.780
70974916|NCT00523991|141456539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.61||95.0|-0.03|0.02||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.02|-0.03|0.610
70974917|NCT00523991|141456540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.554||95.0|-0.02|0.04||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.04|-0.02|0.554
70974918|NCT00523991|141456541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.549||95.0|-0.02|0.04||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.04|-0.02|0.549
70974919|NCT00523991|141456542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.568||95.0|-0.02|0.04||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.04|-0.02|0.568
70974920|NCT00523991|141456544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.358||95.0|-0.18|0.07||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.07|-0.18|0.358
70974921|NCT00523991|141456545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.219||95.0|-0.2|0.05||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.05|-0.20|0.219
71033737|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.19|||<|0.001|TWO_SIDED|95.0|1.59|2.79||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||2.79|1.59|<0.001
70974922|NCT00523991|141456546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.518||95.0|-0.1|0.19||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.19|-0.10|0.518
70974923|NCT00523991|141456547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.455||95.0|-0.09|0.21||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.21|-0.09|0.455
71033738|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.56|||<|0.001|TWO_SIDED|95.0|0.97|2.16||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||2.16|0.97|<0.001
71033739|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|||<|0.001|TWO_SIDED|95.0|1.28|2.52||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||2.52|1.28|<0.001
70974924|NCT00523991|141456548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.927||95.0|-0.16|0.15||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.15|-0.16|0.927
70974925|NCT00523991|141456549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.933||95.0|-0.17|0.16||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.16|-0.17|0.933
71033740|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.13|||<|0.001|TWO_SIDED|95.0|1.52|2.75||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||2.75|1.52|<0.001
71033741|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.59|||<|0.001|TWO_SIDED|95.0|0.98|2.2||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||2.20|0.98|<0.001
71033742|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|||<|0.001|TWO_SIDED|95.0|1.26|2.54||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||2.54|1.26|<0.001
71033743|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03|||<|0.001|TWO_SIDED|95.0|1.39|2.66||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||2.66|1.39|<0.001
71033744|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44|||<|0.001|TWO_SIDED|95.0|0.81|2.07||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||2.07|0.81|<0.001
71033745|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.83|||<|0.001|TWO_SIDED|95.0|1.17|2.49||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||2.49|1.17|<0.001
71033746|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.78|||<|0.001|TWO_SIDED|95.0|1.13|2.43||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||2.43|1.13|<0.001
70974926|NCT00523991|141456550|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.996
71033747|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.42|||<|0.001|TWO_SIDED|95.0|0.78|2.07||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||2.07|0.78|<0.001
70974927|NCT00523991|141456551|SUPERIORITY_OR_OTHER|||||||0.196||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.196
70974928|NCT00523991|141456552|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.800
70974929|NCT00523991|141456553|SUPERIORITY_OR_OTHER|||||||0.215||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.215
70974930|NCT00523991|141456554|SUPERIORITY_OR_OTHER|||||||0.205||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.205
70974931|NCT00523991|141456555|SUPERIORITY_OR_OTHER|||||||0.622||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.622
71033748|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.64|||<|0.001|TWO_SIDED|95.0|0.95|2.32||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||2.32|0.95|<0.001
71033749|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.61|||<|0.001|TWO_SIDED|95.0|0.94|2.29||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||2.29|0.94|<0.001
71033750|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.38|||<|0.001|TWO_SIDED|95.0|0.71|2.06||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||2.06|0.71|<0.001
71033751|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.58|||<|0.001|TWO_SIDED|95.0|0.88|2.27||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||2.27|0.88|<0.001
71033752|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.42|||<|0.001|TWO_SIDED|95.0|0.73|2.1||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||2.10|0.73|<0.001
71033753|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|||<|0.001|TWO_SIDED|95.0|0.72|2.08||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||2.08|0.72|<0.001
71033754|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25|||<|0.001|TWO_SIDED|95.0|0.53|1.96||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||1.96|0.53|<0.001
71033755|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08||||0.003|TWO_SIDED|95.0|0.38|1.79||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||1.79|0.38|0.003
71033756|NCT00913627|141577230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32|||<|0.001|TWO_SIDED|95.0|0.61|2.02||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||2.02|0.61|<0.001
71033757|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.011|TWO_SIDED|95.0|0.12|0.91||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.91|0.12|0.011
71033758|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.028|TWO_SIDED|95.0|0.05|0.83||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.83|0.05|0.028
71033759|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.048|TWO_SIDED|95.0|0.0|0.78||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.78|0.00|0.048
71033760|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32|||<|0.001|TWO_SIDED|95.0|0.69|1.96||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||1.96|0.69|<0.001
71033761|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08|||<|0.001|TWO_SIDED|95.0|0.45|1.71||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||1.71|0.45|<0.001
71095629|NCT00447278|141699633|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.721||||0.004|TWO_SIDED|95.0|0.544|2.899||P-value for Inattention Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||2.899|0.544|0.004
71095630|NCT00447278|141699633|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.269|||<|0.001|TWO_SIDED|95.0|1.086|3.453||P-value for Inattention Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||3.453|1.086|<0.001
70974932|NCT00523991|141456556|SUPERIORITY_OR_OTHER|||||||0.446||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.446
70974933|NCT00523991|141456558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.819||95.0|-0.05|0.06||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms for treatment, site, and baseline value Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.06|-0.05|0.819
70974934|NCT00523991|141456559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.204||95.0|-0.1|0.02||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.02|-0.10|0.204
70974935|NCT00523991|141456560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.67||95.0|-0.08|0.05||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.05|-0.08|0.670
70974936|NCT00523991|141456561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.63||95.0|-0.09|0.06||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms for treatment, site, and baseline value Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.06|-0.09|0.630
70974937|NCT00523991|141456562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.704||95.0|-0.1|0.07||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms for treatment, site, and baseline value Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.07|-0.10|0.704
70974938|NCT00523991|141456563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.579||95.0|-0.11|0.06||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.06|-0.11|0.579
70974939|NCT00523991|141456565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.54||||0.916||95.0|-464.02|416.94||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||416.94|-464.02|0.916
71095631|NCT00447278|141699633|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.58||||0.298|TWO_SIDED|95.0|-0.515|1.676||P-value for Hyperactivity Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||1.676|-0.515|0.298
71095632|NCT00447278|141699633|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.865||||0.119|TWO_SIDED|95.0|-0.225|1.956||P-value for Hyperactivity Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||1.956|-0.225|0.119
71095633|NCT00447278|141699634|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.104||||0.366|TWO_SIDED|95.0|-0.122|0.329||P-value for Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.329|-0.122|0.366
71095634|NCT00447278|141699634|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.169||||0.165|TWO_SIDED|95.0|-0.07|0.407||P-value for Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.407|-0.070|0.165
71095635|NCT00447278|141699635|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.35||||0.054|TWO_SIDED|95.0|-4.74|0.04||P-value for Achievement Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.04|-4.74|0.054
71095636|NCT00447278|141699635|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.71||||0.003|TWO_SIDED|95.0|-6.16|-1.26||P-value for Achievement Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-1.26|-6.16|0.003
71095637|NCT00447278|141699635|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.74||||0.033|TWO_SIDED|95.0|-3.33|-0.14||P-value for Comfort Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.14|-3.33|0.033
70974940|NCT00523991|141456566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.42||||0.899||95.0|-520.19|457.34||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||457.34|-520.19|0.899
70974941|NCT00523991|141456567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|181.99||||0.495||95.0|-341.75|705.73||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||placebo versus tiotropium||705.73|-341.75|0.495
71008443|NCT02394028|141524818|SUPERIORITY||Difference in rate|4.9||||0.7908|TWO_SIDED|95.0|-6.26|16.11||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||16.11|-6.26|0.7908
71095638|NCT00447278|141699635|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.5||||0.003|TWO_SIDED|95.0|-4.12|-0.88||P-value for Comfort Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.88|-4.12|0.003
71095639|NCT00447278|141699635|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.5||||0.623|TWO_SIDED|95.0|-1.5|2.5||P-value for Resilience Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||2.50|-1.50|0.623
71095640|NCT00447278|141699635|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.16||||0.88|TWO_SIDED|95.0|-1.96|2.29||P-value for Resilience Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||2.29|-1.96|0.880
70974942|NCT00523991|141456568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|258.83||||0.318||95.0|-250.37|768.03||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||768.03|-250.37|0.318
70974943|NCT00523991|141456569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|211.18||||0.45||95.0|-338.04|760.39||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||760.39|-338.04|0.450
70974944|NCT00523991|141456570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.46||||0.858||95.0|-512.2|615.12||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||615.12|-512.20|0.858
70974945|NCT03439033|141456575|SUPERIORITY||Risk Difference (RD)|0.42|||<|0.0001|TWO_SIDED|95.0|0.3|0.53|||McNemar||Risk difference reflects PSMA PET/MRI Scan detection proportion minus MRI scan detection proportion.|||0.53|0.30|<0.0001
70974946|NCT02435849|141456586|OTHER|testing the null hypothesis that ORR within 3 months is less than or equal to 20%|||||<|0.0001|||||||Clopper-Pearson|||||||<.0001
70974947|NCT02435849|141456588|OTHER|testing the null hypothesis that ORR with MRD negative within 3 months is less than or equal to 15%|||||<|0.0001|||||||Clopper-Pearson|||||||<.0001
70974948|NCT02435849|141456589|OTHER|testing the null hypothesis that ORR with MRD negative within 3 months is less than or equal to 15%|||||<|0.0001|||||||Clopper-Pearson|||||||<.0001
70974949|NCT04849780|141456621|NON_INFERIORITY|It was calculated that 80 participants randomized in a 1:1 fashion between the two arms would have at least 80% power to detect a 5 points difference in mean change from baseline overall comfort. Sample size was determined using a 2-sided Satterthwaite t-test assuming unequal variances with an alpha level of 5%. A non-inferiority margin of -5 points was used.|Population Mean Difference|29.279|||||TWO_SIDED|95.0|24.602|33.732|||Bootstrapping methods||Population Mean difference was calculated as Arm 1 minus Arm 2|||33.732|24.602|
70974950|NCT04849780|141456622|NON_INFERIORITY|Sample size was determined based on the primary hypothesis only. A non-inferiority margin of 3 points was used.|LS Mean|-10.7|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-12.7|-8.6|||Heterogeneous Mixed model analysis|The Kenward and Roger method was used for the denominator degrees of freedom.|Mean difference was calculated as Arm 1 minus Arm 2 (subjects' own contact lens)|||-8.6|-12.7|
70974951|NCT04849780|141456623|NON_INFERIORITY|Sample size was determined based on the primary hypothesis only. A non-inferiority margin of -5 points was used.|LS Mean|25.9|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|19.0|32.9|||Heterogeneous Mixed model analysis|The Kenward and Roger method was used for the denominator degrees of freedom.|Mean difference was calculated as Arm 2 (senofilcon A), minus Arm 2 (subjects' own contact lens)|||32.9|19.0|
70974952|NCT04849780|141456624|NON_INFERIORITY|A non-inferiority margin of 3 points was used.|LS Mean|-8.5|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-10.1|-7.0|||Heterogeneous mixed model analysis||Mean difference was calculated as Arm 2 (senofilcon A) minus Arm 2 (subjects' own contact lens)|||-7.0|-10.1|
70974953|NCT01724528|141456660|SUPERIORITY_OR_OTHER||Least squares means difference|-196.794|||<|0.0001|TWO_SIDED|95.0|-238.6|-154.988|||ANCOVA|||Treatment, TLS risk (intermediate/high) and sUA level at baseline (≤ 7.5 mg/dL and \> 7.5 mg/dL) were inserted in the ANCOVA model as covariates||-154.988|-238.600|<0.0001
70974954|NCT01724528|141456661|SUPERIORITY_OR_OTHER||Least squares means difference|4.097||||0.0903|TWO_SIDED|95.0|-0.6467|8.8406|||ANCOVA|||Treatment, TLS risk (intermediate/high) and sUA level at baseline (≤ 7.5 mg/dL and \> 7.5 mg/dL) were inserted in the ANCOVA model as covariates||8.8406|-0.6467|0.0903
70974955|NCT01724528|141456662|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0231||||0.1993|TWO_SIDED|95.0|-0.0153|0.0654|||Wilson's confidence interval|||||0.0654|-0.0153|0.1993
70974956|NCT01724528|141456663|SUPERIORITY_OR_OTHER||Relative risk|0.875||||0.8488|TWO_SIDED|95.0|0.4408|1.7369|||Chi-squared|||||1.7369|0.4408|0.8488
70974957|NCT01724528|141456664|SUPERIORITY_OR_OTHER||Relative risk|0.994||||1|TWO_SIDED|95.0|0.9691|1.0199|||Chi-squared|||||1.0199|0.9691|1.0000
70974958|NCT04247425|141456670|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||Baseline compared to end of 12 week exercise intervention||||0.59
70974959|NCT04247425|141456671|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Baseline compared to end of 12 week exercise intervention||||0.02
70974960|NCT04247425|141456672|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Baseline compared to end of 12 week exercise intervention||||1.0
70974961|NCT04247425|141456673|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Baseline compared to end of 12 week exercise intervention||||0.09
70974962|NCT01227902|141456685|SUPERIORITY_OR_OTHER||percentage of participants|40.0|||||TWO_SIDED|95.0|27.1|52.9|||||The estimated value represents the percentage of participants with a \>=50% reduction in partial-onset seizure frequency from Baseline.|||52.9|27.1|
70974963|NCT01227902|141456685|SUPERIORITY_OR_OTHER||percentage of participants|32.0|||||TWO_SIDED|95.0|19.1|44.9|||||The estimated value represents the percentage of participants with a \>=50% reduction in partial-onset seizure frequency from Baseline.|||44.9|19.1|
70974964|NCT01227902|141456685|SUPERIORITY_OR_OTHER||percentage of participants|50.0|||||TWO_SIDED|95.0|35.2|64.8|||||The estimated value represents the percentage of participants with a \>=50% reduction in partial-onset seizure frequency from Baseline.|||64.8|35.2|
70974965|NCT01227902|141456685|SUPERIORITY_OR_OTHER||percentage of participants|56.9|||||TWO_SIDED|95.0|43.3|70.5|||||The estimated value represents the percentage of participants with a \>=50% reduction in partial-onset seizure frequency from Baseline.|||70.5|43.3|
70974966|NCT01227902|141456685|SUPERIORITY_OR_OTHER||percentage of participants|44.5|||||TWO_SIDED|95.0|37.6|51.4|||||The estimated value represents the percentage of participants with a \>=50% reduction in partial-onset seizure frequency from Baseline.|||51.4|37.6|
70974967|NCT00930059|141456705|SUPERIORITY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.73||0.3353|TWO_SIDED|90.0|-1.52|0.9||The primary test of significance was 1-sided, and a nominal Type I error rate a = 0.05 was employed.|ANCOVA|||Least squares (LS) mean difference and p-values were based on analysis of covariance (ANCOVA) on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||0.90|-1.52|0.3353
70974968|NCT00930059|141456706|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.72||0.6073|TWO_SIDED|90.0|-0.99|1.38||No adjustments made for multiple comparisons.|ANCOVA|||Change at Week 3: LS mean difference and p-values were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||1.38|-0.99|0.6073
70974969|NCT00930059|141456706|SUPERIORITY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.73||0.3086|TWO_SIDED|90.0|-1.56|0.84||No adjustments made for multiple comparisons.|ANCOVA|||Change at Week 6: LS mean difference and p-values were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||0.84|-1.56|0.3086
70974970|NCT00930059|141456706|SUPERIORITY||LS mean difference|-0.62|STANDARD_ERROR_OF_MEAN|0.73||0.197|TWO_SIDED|90.0|-1.82|0.58||No adjustments made for multiple comparisons.|ANCOVA|||Change at Week 9: LS mean difference and p-values were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||0.58|-1.82|0.1970
70974971|NCT00930059|141456707|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.14||0.6547|TWO_SIDED|90.0|-0.18|0.29||No adjustments made for multiple comparisons.|Linear model|||Week 3: Inferential statistics were based on linear model with fixed effects for visit (nominal scale) and visit by treatment interaction, and a random effect for participant.||0.29|-0.18|0.6547
70974972|NCT00930059|141456707|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.14||0.702|TWO_SIDED|90.0|-0.16|0.31||No adjustments made for multiple comparisons.|Linear model|||Week 6: Inferential statistics were based on linear model with fixed effects for visit (nominal scale) and visit by treatment interaction, and a random effect for participant.||0.31|-0.16|0.7020
70974973|NCT00930059|141456707|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.1138|TWO_SIDED|90.0|-0.41|0.06||No adjustments made for multiple comparisons.|Linear model|||Week 9: Inferential statistics were based on linear model with fixed effects for visit (nominal scale) and visit by treatment interaction, and a random effect for participant.||0.06|-0.41|0.1138
70974974|NCT00930059|141456707|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.0816|TWO_SIDED|90.0|-0.44|0.04||No adjustments made for multiple comparisons.|Linear model|||Week 12: Inferential statistics were based on linear model with fixed effects for visit (nominal scale) and visit by treatment interaction, and a random effect for participant.||0.04|-0.44|0.0816
70974975|NCT00930059|141456709|SUPERIORITY||LS mean difference|0.69|STANDARD_ERROR_OF_MEAN|0.96||0.7634|TWO_SIDED|90.0|-0.89|2.27||No adjustments have been made for multiple comparisons.|ANCOVA|||Change at Week 3: LS mean difference and p-value were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||2.27|-0.89|0.7634
70974976|NCT00930059|141456709|SUPERIORITY||LS mean difference|0.85|STANDARD_ERROR_OF_MEAN|0.97||0.8077|TWO_SIDED|90.0|-0.75|2.45||No adjustments made for multiple comparisons.|ANCOVA|||Change at Week 6: LS mean difference and p-value were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||2.45|-0.75|0.8077
70974977|NCT00930059|141456709|SUPERIORITY||LS mean difference|0.96|STANDARD_ERROR_OF_MEAN|0.98||0.835|TWO_SIDED|90.0|-0.66|2.57||No adjustments made for multiple comparisons.|ANCOVA|||Change at Week 9: LS mean difference and p-value were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||2.57|-0.66|0.8350
70974978|NCT00930059|141456709|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.99||0.4377|TWO_SIDED|90.0|-1.78|1.48||No adjustments made for multiple comparisons.|ANCOVA|||Change at Week 12: LS mean difference and p-value were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||1.48|-1.78|0.4377
70974979|NCT01641120|141456780|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon Signed Ranks|||||||<.05
70974980|NCT01641120|141456781|SUPERIORITY_OR_OTHER|||||||0.193|TWO_SIDED||||||Wilcoxon Signed Ranks|||||||0.193
70974981|NCT01641120|141456782|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||Wilcoxon Signed Ranks|||||||0.035
70974982|NCT01641120|141456783|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Wilcoxon Signed Ranks|||||||.005
70974983|NCT03160560|141456786|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Baseline, Week 1, Week 2, Week 3||||<0.010
70974984|NCT03160560|141456786|SUPERIORITY|||||||0.932|||||||Wilcoxon (Mann-Whitney)|||Baseline, Week 1, Week 2, Week 3||||.932
70974985|NCT03160560|141456786|SUPERIORITY|||||||0.853|||||||Wilcoxon (Mann-Whitney)|||Baseline 2, Week 6, Week 7, Week 8||||.853
70974986|NCT03160560|141456786|SUPERIORITY|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||Baseline-2, Week 6, Week 7, Week 8||||.032
70974987|NCT03160560|141456786|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Baseline, Week 1, Week 2, Week 3||||<0.001
70974988|NCT03160560|141456786|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Baseline, Week 1, Week 2, Week 3||||.750
70974989|NCT03160560|141456786|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Baseline 2, Week 6, Week 7, Week 8||||.810
70974990|NCT03160560|141456786|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||Baseline 2, Week 6, Week 7, Week 8||||.006
70974991|NCT01664793|141456787|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|Chi-square tests for comparisons of between-arm changes in vaccination rates from pre to post intervention.||||||<0.05
71095641|NCT00447278|141699635|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.4||||0.149|TWO_SIDED|95.0|-3.31|0.5||P-value for Risk Avoidance Change: 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.50|-3.31|0.149
71095642|NCT00447278|141699635|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.78||||0.003|TWO_SIDED|95.0|-4.58|-0.98||P-value for Risk Avoidance Change: 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.98|-4.58|0.003
70974992|NCT02634580|141456811|SUPERIORITY||LS Mean Treatment Difference|-39.35|STANDARD_ERROR_OF_MEAN|3.93|<|0.0001|TWO_SIDED|95.0|-47.23|-31.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-31.48|-47.23|<0.0001
70974993|NCT02634580|141456812|SUPERIORITY||LS Mean Treatment Difference|-40.14|STANDARD_ERROR_OF_MEAN|4.26|<|0.0001|TWO_SIDED|95.0|-48.68|-31.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-31.60|-48.68|< 0.0001
70974994|NCT02634580|141456813|SUPERIORITY||LS Mean Treatment Difference|-77.6|STANDARD_ERROR_OF_MEAN|8.1|<|0.0001|TWO_SIDED|95.0|-93.9|-61.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-61.3|-93.9|<0.0001
70974995|NCT02634580|141456814|SUPERIORITY||LS Mean Treatment Difference|-79.4|STANDARD_ERROR_OF_MEAN|8.7|<|0.0001|TWO_SIDED|95.0|-96.7|-62.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-62.0|-96.7|<0.0001
70974996|NCT02634580|141456815|SUPERIORITY||Treatment Difference|56.41|||<|0.0001|TWO_SIDED|95.0|34.1|70.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Ezetimibe|||70.70|34.10|<0.0001
70974997|NCT02634580|141456816|SUPERIORITY||Treatment Difference|52.63|||<|0.0001|TWO_SIDED|95.0|30.36|67.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Ezetimibe|||67.52|30.36|< 0.0001
70974998|NCT02634580|141456817|SUPERIORITY||LS Mean Treatment Difference|-25.44|STANDARD_ERROR_OF_MEAN|2.68|<|0.0001|TWO_SIDED|95.0|-30.8|-20.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-20.08|-30.80|<0.0001
70974999|NCT02634580|141456818|SUPERIORITY||LS Mean Treatment Difference|-25.83|STANDARD_ERROR_OF_MEAN|2.89|<|0.0001|TWO_SIDED|95.0|-31.63|-20.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-20.04|-31.63|<0.0001
70975000|NCT02634580|141456819|SUPERIORITY||LS Mean Treatment Difference|-33.53|STANDARD_ERROR_OF_MEAN|3.42|<|0.0001|TWO_SIDED|95.0|-40.38|-26.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-26.68|-40.38|< 0.0001
70975001|NCT02634580|141456820|SUPERIORITY||LS Mean Treatment Difference|-33.44|STANDARD_ERROR_OF_MEAN|3.75|<|0.0001|TWO_SIDED|95.0|-40.94|-25.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-25.94|-40.94|<0.0001
70975002|NCT02634580|141456821|SUPERIORITY||LS Mean Treatment Difference|-35.67|STANDARD_ERROR_OF_MEAN|3.31|<|0.0001|TWO_SIDED|95.0|-42.3|-29.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-29.04|-42.30|< 0.0001
70975003|NCT02634580|141456822|SUPERIORITY||LS Mean Treatment Difference|-36.6|STANDARD_ERROR_OF_MEAN|3.68|<|0.0001|TWO_SIDED|95.0|-43.98|-29.22||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-29.22|-43.98|<0.0001
70975004|NCT02634580|141456823|SUPERIORITY||LS Mean Treatment Difference|-28.61|STANDARD_ERROR_OF_MEAN|3.32|<|0.0001|TWO_SIDED|95.0|-35.26|-21.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-21.97|-35.26|< 0.0001
70975005|NCT02634580|141456824|SUPERIORITY||LS Mean Treatment Difference|-27.05|STANDARD_ERROR_OF_MEAN|3.47|<|0.0001|TWO_SIDED|95.0|-34.0|-20.09||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-20.09|-34.00|< 0.0001
70975006|NCT02634580|141456825|SUPERIORITY||LS Mean Treatment Difference|-37.07|STANDARD_ERROR_OF_MEAN|3.28|<|0.0001|TWO_SIDED|95.0|-43.65|-30.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-30.50|-43.65|<0.0001
71095643|NCT00447278|141699635|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.62||||0.015|TWO_SIDED|95.0|-4.71|-0.52||P-value for Satisfaction Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.52|-4.71|0.015
70975007|NCT02634580|141456826|SUPERIORITY||LS Mean Treatment Difference|-36.29|STANDARD_ERROR_OF_MEAN|3.54|<|0.0001|TWO_SIDED|95.0|-43.39|-29.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-29.20|-43.39|<0.0001
70975008|NCT02634580|141456827|SUPERIORITY||LS Mean Treatment Difference|-31.13|STANDARD_ERROR_OF_MEAN|5.34|<|0.0001|TWO_SIDED|95.0|-41.83|-20.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-20.43|-41.83|<0.0001
70975009|NCT02634580|141456828|SUPERIORITY||LS Mean Treatment Difference|-31.21|STANDARD_ERROR_OF_MEAN|6.17|<|0.0001|TWO_SIDED|95.0|-43.57|-18.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-18.84|-43.57|<0.0001
71095644|NCT00447278|141699635|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.12||||0.004|TWO_SIDED|95.0|-5.26|-0.98||P-value for Satisfaction Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.98|-5.26|0.004
71095645|NCT00447278|141699636|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.39||||0.263|TWO_SIDED|95.0|-1.83|6.6||P-value for Achievement Change at 4 Month LOCF. Achievement was derived from the academic achievement subdomain only.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||6.60|-1.83|0.263
70975010|NCT02634580|141456829|SUPERIORITY||LS Mean Treatment Difference|3.49|STANDARD_ERROR_OF_MEAN|7.31||0.63|TWO_SIDED|95.0|-11.15|18.13||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||18.13|-11.15|0.63
70975011|NCT02634580|141456830|SUPERIORITY||LS Mean Treatment Difference|11.79|STANDARD_ERROR_OF_MEAN|9.52||0.22|TWO_SIDED|95.0|-7.29|30.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||30.87|-7.29|0.22
70975012|NCT02634580|141456831|SUPERIORITY||LS Mean Treatment Difference|7.96|STANDARD_ERROR_OF_MEAN|3.08||0.012|TWO_SIDED|95.0|1.78|14.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||14.14|1.78|0.012
70975013|NCT02634580|141456832|SUPERIORITY||LS Mean Treatment Difference|5.59|STANDARD_ERROR_OF_MEAN|3.2||0.086|TWO_SIDED|95.0|-0.82|12.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||12.00|-0.82|0.086
70975014|NCT02634580|141456833|SUPERIORITY||LS Mean Treatment Difference|-0.67|STANDARD_ERROR_OF_MEAN|7.26||0.93|TWO_SIDED|95.0|-15.22|13.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||13.87|-15.22|0.93
70975015|NCT02634580|141456834|SUPERIORITY||LS Mean Treatment Difference|7.64|STANDARD_ERROR_OF_MEAN|9.88||0.44|TWO_SIDED|95.0|-12.15|27.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||27.43|-12.15|0.44
70975016|NCT03222427|141456835|OTHER||Ratio of Geometric Least Squares Means|0.952|||||TWO_SIDED|90.0|0.769|1.18||||||||1.18|0.769|
70975017|NCT03106779|141456837|SUPERIORITY||treatment difference in the MMR rate|12.2||||0.029|TWO_SIDED|95.0|2.19|22.3|||Cochran-Mantel-Haenszel|Stratified by the randomization stratification factor, i.e. cytogenetic response status (MCyR vs no MCyR) at screening||||22.30|2.19|0.029
70975018|NCT02288247|141456852|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.027|TWO_SIDED|95.0|0.53|0.96||From the Cox proportional hazards model with covariates for treatment and disease progression in Period 1 (radiographic, nonradiographic).|Cox proportional hazards model|||||0.96|0.53|0.027
70975019|NCT02288247|141456853|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.002|TWO_SIDED|95.0|0.41|0.82||From the Cox proportional hazards model with covariates for treatment and disease progression in Period 1 (radiographic, nonradiographic).|Cox proportional hazards model|||||0.82|0.41|0.002
70975020|NCT02288247|141456855|SUPERIORITY|||||||0.142||||||From the Cochran-Mantel-Haenszel test stratified by disease progression (radiographic, non-radiographic) in Period 1.|Cochran-Mantel-Haenszel|||||||0.142
71095646|NCT00447278|141699636|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.38||||0.848|TWO_SIDED|95.0|-3.6|4.36||P-value for Achievement Change at 6 Month LOCF. Achievement was derived from the academic achievement subdomain only.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||4.36|-3.60|0.848
71095647|NCT00447278|141699636|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.19||||0.895|TWO_SIDED|95.0|-3.01|2.64||P-value for Statisfaction Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||2.64|-3.01|0.895
71095648|NCT00447278|141699636|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.2||||0.038|TWO_SIDED|95.0|-6.22|-0.19||P-value for Satisfaction Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.19|-6.22|0.038
70975021|NCT02288247|141456858|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.994|TWO_SIDED|95.0|0.47|2.13||From the Cox proportional hazards model with covariates for treatment and disease progression in Period 1 (radiographic, nonradiographic).|Cox proportional hazards model|||||2.13|0.47|0.994
70975022|NCT02918019|141456875|OTHER||Rate Ratio|0.57||||0.0049|TWO_SIDED|95.0|0.39|0.84|||Poisson regression|||||0.84|0.39|0.0049
70975023|NCT02918019|141456875|OTHER||Rate Ratio|0.78||||0.1838|TWO_SIDED|95.0|0.54|1.12|||Poisson regression|||||1.12|0.54|0.1838
70975024|NCT02918019|141456875|OTHER||Rate Ratio|0.63||||0.0144|TWO_SIDED|95.0|0.44|0.91|||Poisson regression|||||0.91|0.44|0.0144
70975025|NCT00094757|141456890|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|0.9|<|0.001|TWO_SIDED|95.0|-0.82|-0.39||Model terms: treatment, baseline, prior anti-hyperglycemic therapy status (on vs. not on prior therapy)|ANCOVA|||||-0.39|-0.82|<0.001
70975026|NCT00094757|141456890|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48|STANDARD_DEVIATION|0.9|<|0.001|TWO_SIDED|95.0|-0.7|-0.26|||ANCOVA|Model terms: treatment, baseline, prior anti-hyperglycemic therapy status (on vs. not on prior therapy)||||-0.26|-0.70|<0.001
70975027|NCT00094757|141456891|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.7|STANDARD_DEVIATION|45.9|<|0.001|TWO_SIDED|95.0|-30.5|-8.9|||ANCOVA|Model terms: treatment, baseline, prior anti-hyperglycemic therapy status||||-8.9|-30.5|<0.001
70975028|NCT00094757|141456891|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.9|STANDARD_DEVIATION|45.9|<|0.002|TWO_SIDED|95.0|-27.6|-6.1|||ANCOVA|Model terms: treatment, baseline, prior anti-hyperglycemic therapy status||||-6.1|-27.6|<0.002
70975029|NCT01808612|141456894|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73||||0.264|TWO_SIDED|95.0|-0.55|2.0|||Mixed Models Analysis|||Approximately 522 participants were to be enrolled. Randomization was to be 2:1:3 (20 mg fluoxetine:40 mg fluoxetine:placebo). Assuming 5% of participants would have missing post-baseline data, the study had 85% power to detect an effect size of 0.33 (20 mg fluoxetine compared to placebo on HAMD21 total score) based on simulations with a 0.05 two-sided significance level.||2.00|-0.55|0.264
70975030|NCT00756938|141456901|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.22||||0.753|TWO_SIDED|95.0|-6.45|8.9|||ANCOVA|Analysis of covariance (ANCOVA) model with terms for dose, weight (as a continuous covariate) and presence of co-morbidities/end organ damage||||8.90|-6.45|0.753
70975031|NCT00756938|141456902|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.81||||0.643|TWO_SIDED|95.0|-5.9|9.51|||ANCOVA|Analysis of covariance (ANCOVA) model with terms for dose, weight (as a continuous covariate) and presence of co-morbidities/end organ damage||||9.51|-5.90|0.643
70975032|NCT03175549|141456909|SUPERIORITY||Mean Difference (Final Values)|5.53|STANDARD_ERROR_OF_MEAN|10.1||0.36|TWO_SIDED|95.0|-10.22|29.38||A priori threshold for significance was 0.05.|Mixed Models Analysis||Standard error was calculated using bootstrap methods which is considered best for MEM.|||29.38|-10.22|0.36
70975033|NCT03175549|141456910|SUPERIORITY||Slope|-0.067|STANDARD_ERROR_OF_MEAN|0.03|<|0.025|TWO_SIDED||||||t-test, 2 sided|||Posted results show mean change in drinking for the drug group relative to placebo for each day of the 11 days of ad libidum drinking (Days 1-11) permitted during the 14 days (2 weeks) of medication.||||<0.025
70975034|NCT03175549|141456910|SUPERIORITY||Slope|-0.067|STANDARD_ERROR_OF_MEAN|0.03||0.025|TWO_SIDED||||||Mixed Models Analysis|473 daily observations within 43 individuals.|The apremilast group showed a significantly more rapid reduction in drinks per day relative to placebo.|||||0.025
70975035|NCT02793232|141456962|SUPERIORITY||Percent change from baseline|-79.456|STANDARD_ERROR_OF_MEAN|0.0819|<|0.0001|TWO_SIDED|80.0|-81.56|-77.11|||Mixed Models Analysis|||ABeta 1-38: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-77.11|-81.56|<0.0001
70975036|NCT02793232|141456962|SUPERIORITY||Percent change from baseline|-87.403|STANDARD_ERROR_OF_MEAN|0.0887|<|0.0001|TWO_SIDED|80.0|-88.8|-85.84|||Mixed Models Analysis|||ABeta 1-38: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-85.84|-88.80|<0.0001
70975037|NCT02793232|141456962|SUPERIORITY||Percent change from baseline|-83.83|STANDARD_ERROR_OF_MEAN|0.0905|<|0.0001|TWO_SIDED|80.0|-85.65|-81.78|||Mixed Models Analysis|||ABeta 1-40: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-81.78|-85.65|<0.0001
70975038|NCT02793232|141456962|SUPERIORITY||Percent change from baseline|-92.138|STANDARD_ERROR_OF_MEAN|0.1041|<|0.0001|TWO_SIDED|80.0|-93.15|-90.98|||Mixed Models Analysis|||ABeta 1-40: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-90.98|-93.15|<0.0001
71033762|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01||||0.002|TWO_SIDED|95.0|0.38|1.63||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||1.63|0.38|0.002
71033763|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.26|||<|0.001|TWO_SIDED|95.0|1.46|3.06||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||3.06|1.46|<0.001
71033764|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03|||<|0.001|TWO_SIDED|95.0|1.24|2.82||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||2.82|1.24|<0.001
71033765|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.52|||<|0.001|TWO_SIDED|95.0|0.74|2.31||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||2.31|0.74|<0.001
71033766|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.64|||<|0.001|TWO_SIDED|95.0|1.78|3.5||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||3.50|1.78|<0.001
70975039|NCT02793232|141456962|SUPERIORITY||Percent change from baseline|-84.814|STANDARD_ERROR_OF_MEAN|0.0971|<|0.0001|TWO_SIDED|80.0|-86.64|-82.74|||Mixed Models Analysis|||ABeta 1-42: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-82.74|-86.64|<0.0001
70975040|NCT02793232|141456962|SUPERIORITY||Percent change from baseline|-92.87|STANDARD_ERROR_OF_MEAN|0.1114|<|0.0001|TWO_SIDED|80.0|-93.85|-91.74|||Mixed Models Analysis|||ABeta 1-42: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-91.74|-93.85|<0.0001
71033767|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.66|||<|0.001|TWO_SIDED|95.0|1.81|3.51||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||3.51|1.81|<0.001
71033768|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.16|||<|0.001|TWO_SIDED|95.0|1.32|3.0||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||3.00|1.32|<0.001
71033769|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.26|||<|0.001|TWO_SIDED|95.0|2.39|4.12||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||4.12|2.39|<0.001
70921900|NCT04992390|141334081|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-2.92|||<=|0.001|TWO_SIDED|95.0|-3.9|-1.95||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Intrusive memory ratings, 'How much did they interfere with what you were doing?' (treatment effects for between-arm comparisons) at week 4. For full information on statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-1.95|-3.90|<= 0.001
70921901|NCT04992390|141334081|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-2.15|||<=|0.001|TWO_SIDED|95.0|-3.22|-1.08||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Intrusive memory ratings, 'How much did your intrusive memories affect your work functioning?' (treatment effects for between-arm comparisons) at week 4. For full information on statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-1.08|-3.22|<= 0.001
70975041|NCT02793232|141456962|SUPERIORITY||Percent change from baseline|-79.465|STANDARD_ERROR_OF_MEAN|0.087|<|0.0001|TWO_SIDED|80.0|-81.69|-76.96|||Mixed Models Analysis|||ABeta x-38: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-76.96|-81.69|<0.0001
70975042|NCT02793232|141456962|SUPERIORITY||Percent change from baseline|-88.711|STANDARD_ERROR_OF_MEAN|0.0963|<|0.0001|TWO_SIDED|80.0|-90.06|-87.18|||Mixed Models Analysis|||ABeta x-38: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-87.18|-90.06|<0.0001
71095649|NCT00447278|141699636|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.3||||0.854|TWO_SIDED|95.0|-3.59|2.98||P-value for Comfort Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||2.98|-3.59|0.854
70975043|NCT02793232|141456962|SUPERIORITY||Percent change from baseline|-78.936|STANDARD_ERROR_OF_MEAN|0.0824|<|0.0001|TWO_SIDED|80.0|-81.11|-76.52|||Mixed Models Analysis|||ABeta x-40: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-76.52|-81.11|<0.0001
70975044|NCT02793232|141456962|SUPERIORITY||Percent change from baseline|-86.28|STANDARD_ERROR_OF_MEAN|0.0899|<|0.0001|TWO_SIDED|80.0|-87.82|-84.55|||Mixed Models Analysis|||ABeta x-40: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-84.55|-87.82|<0.0001
70975045|NCT02793232|141456962|SUPERIORITY||Percent change from baseline|-79.648|STANDARD_ERROR_OF_MEAN|0.0664|<|0.0001|TWO_SIDED|80.0|-81.36|-77.78|||Mixed Models Analysis|||ABeta x-42: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-77.78|-81.36|<0.0001
70975046|NCT02793232|141456962|SUPERIORITY||Percent change from baseline|-84.985|STANDARD_ERROR_OF_MEAN|0.0715|<|0.0001|TWO_SIDED|80.0|-86.34|-83.5|||Mixed Models Analysis|||ABeta x-42: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-83.50|-86.34|<0.0001
70975047|NCT02793232|141456962|SUPERIORITY||Percent change from baseline|72.893|STANDARD_ERROR_OF_MEAN|0.0809|<|0.0001|TWO_SIDED|80.0|55.37|92.4|||Mixed Models Analysis|||sAPP-alpha: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||92.40|55.37|<0.0001
70975048|NCT02793232|141456962|SUPERIORITY||Percent change from baseline|98.049|STANDARD_ERROR_OF_MEAN|0.0897|<|0.0001|TWO_SIDED|80.0|75.92|122.96|||Mixed Models Analysis|||sAPP-alpha: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||122.96|75.92|<0.0001
70975049|NCT02793232|141456962|SUPERIORITY||Percent change from baseline|-80.164|STANDARD_ERROR_OF_MEAN|0.0668|<|0.0001|TWO_SIDED|80.0|-81.84|-78.33|||Mixed Models Analysis|||sAPP-beta: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-78.33|-81.84|<0.0001
70975050|NCT02793232|141456962|SUPERIORITY||Percent change from baseline|-83.381|STANDARD_ERROR_OF_MEAN|0.0733|<|0.0001|TWO_SIDED|80.0|-84.92|-81.69|||Mixed Models Analysis|||sAPP-beta: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-81.69|-84.92|<0.0001
70975051|NCT02793232|141456962|SUPERIORITY||Percent change from baseline|-78.408|STANDARD_ERROR_OF_MEAN|0.0602|<|0.0001|TWO_SIDED|80.0|-80.06|-76.62|||Mixed Models Analysis|||Abeta total: General linear model with treatment, as the fixed effect and loge(baseline) as covariate||-76.62|-80.06|<0.0001
70975052|NCT02793232|141456962|SUPERIORITY||Percent change from baseline|-85.365|STANDARD_ERROR_OF_MEAN|0.0653|<|0.0001|TWO_SIDED|80.0|-86.57|-84.05|||Mixed Models Analysis|||Abeta total: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-84.05|-86.57|<0.0001
70975053|NCT01405053|141456972|SUPERIORITY||LS Mean difference|2.601|STANDARD_ERROR_OF_MEAN|6.558||0.6928|TWO_SIDED|95.0|-10.5|15.7|||ANCOVA|||The primary statistical model for comparing the 2 treatment groups was an analysis of covariance (ANCOVA) mixed model for repeated measures with baseline score, age, and sex as covariates, and treatment, week, and treatment by week interaction as factors.||15.7|-10.5|0.6928
70975054|NCT02551159|141456982|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.787|TWO_SIDED|95.0|0.69|1.32||2 sided|Log Rank|||Statistical analysis of number of deaths||1.32|0.69|0.787
70975055|NCT02551159|141456984|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.634|TWO_SIDED|95.0|0.8|1.39||2 sided|Log Rank|||||1.39|0.80|0.634
70975056|NCT02551159|141456986|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.287|TWO_SIDED|95.0|0.94|1.8||2 sided|Log Rank|||||1.80|0.94|0.287
71095650|NCT00447278|141699636|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.26||||0.161|TWO_SIDED|95.0|-5.45|0.92||P-value for Comfort Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.92|-5.45|0.161
70975057|NCT02551159|141456986|SUPERIORITY||Hazard Ratio (HR)|1.32||||0.028|TWO_SIDED|95.0|0.99|1.76||2 sided|Log Rank|||||1.76|0.99|0.028
70975058|NCT02551159|141456987|SUPERIORITY||Odds Ratio (OR)|0.19|||<|0.001|TWO_SIDED|95.0|0.1|0.37||2 sided|Regression, Logistic|||Statistical analysis of number with a response||0.37|0.10|<0.001
70975059|NCT02551159|141456987|SUPERIORITY||Odds Ratio (OR)|0.34|||<|0.001|TWO_SIDED|95.0|0.2|0.57||2 sided|Regression, Logistic|||Statistical analysis of number with a response||0.57|0.20|<0.001
70975060|NCT02551159|141456989|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.811|TWO_SIDED|95.0|0.83|1.27||2 sided|Log Rank|||Statistical analysis of number of deaths||1.27|0.83|0.811
70975061|NCT02551159|141456989|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.624|TWO_SIDED|95.0|0.87|1.25|||Log Rank|||Statistical analysis of number of deaths||1.25|0.87|0.624
70975062|NCT02551159|141456992|SUPERIORITY||Hazard Ratio (HR)|1.36||||0.006|TWO_SIDED|95.0|1.1|1.68||2 sided|Log Rank|||||1.68|1.10|0.006
70975063|NCT02551159|141456992|SUPERIORITY||Hazard Ratio (HR)|1.27||||0.008|TWO_SIDED|95.0|1.06|1.53||2 sided|Log Rank|||||1.53|1.06|0.008
70975064|NCT02551159|141456993|SUPERIORITY||Odds Ratio (OR)|0.21|||<|0.001|TWO_SIDED|95.0|0.13|0.33||2 sided|Regression, Logistic|||||0.33|0.13|<0.001
70975065|NCT02551159|141456993|SUPERIORITY||Odds Ratio (OR)|0.29|||<|0.001|TWO_SIDED|95.0|0.2|0.41||2 sided|Regression, Logistic|||||0.41|0.20|<0.001
70975066|NCT00993928|141457001|SUPERIORITY_OR_OTHER_LEGACY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||Comparison of Q3: Percent change in sleep latency from baseline to week 7.||||0.85
70975067|NCT00993928|141457001|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||Comparison of Q6A: Percent change in time to fall back asleep from baseline to week 7.||||0.86
70975068|NCT00993928|141457003|SUPERIORITY_OR_OTHER_LEGACY|||||||0.42|||||||Chi-squared|||||||0.42
70975069|NCT00993928|141457005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64|||||||t-test, 2 sided|||Compare percent change from baseline to week 7 Distress Thermometer score.||||0.64
70975070|NCT04871711|141457006|SUPERIORITY||Risk Difference (RD)|9.8||||0.006|TWO_SIDED|95.0|3.6|16.1||5% significance level (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||16.1|3.6|0.006
70975071|NCT04871711|141457007|SUPERIORITY||Risk Difference (RD)|24.1|||<|0.001|TWO_SIDED|95.0|15.5|32.6||Evaluated at 5% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||32.6|15.5|<0.001
70975072|NCT04871711|141457008|SUPERIORITY||Risk Difference (RD)|22.8|||<|0.001|TWO_SIDED|95.0|14.0|31.7||Evaluated at 5% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||31.7|14.0|<0.001
70975073|NCT04871711|141457009|SUPERIORITY||Risk Difference (RD)|12.3||||0.001|TWO_SIDED|95.0|5.7|18.9||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||18.9|5.7|0.001
70975074|NCT04871711|141457010|SUPERIORITY||Risk Difference (RD)|10.4|||<|0.001|TWO_SIDED|95.0|5.3|15.6||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||15.6|5.3|<0.001
70975075|NCT04871711|141457011|SUPERIORITY||Risk Difference (RD)|21.0|||<|0.001|TWO_SIDED|95.0|12.6|29.4||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||29.4|12.6|<0.001
70975076|NCT04871711|141457012|SUPERIORITY||Risk Difference (RD)|19.5|||<|0.001|TWO_SIDED|95.0|12.5|26.5||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||26.5|12.5|<0.001
71008444|NCT02394028|141524818|SUPERIORITY||Difference in rate|5.8||||0.317|TWO_SIDED|95.0|-5.43|17.05||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||17.05|-5.43|0.3170
71033770|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.42|||<|0.001|TWO_SIDED|95.0|2.57|4.28||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||4.28|2.57|<0.001
71033771|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.77|||<|0.001|TWO_SIDED|95.0|1.92|3.63||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||3.63|1.92|<0.001
70921902|NCT04992390|141334081|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-2.59|||<=|0.001|TWO_SIDED|95.0|-3.67|-1.51||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Intrusive memory ratings, 'How much did your intrusive memories affect your functioning in other areas of your life?' (treatment effects for between-arm comparisons) at week 4. For full information on statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-1.51|-3.67|<= 0.001
70921903|NCT04992390|141334084|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.8|||<=|0.001|TWO_SIDED|95.0|-1.08|-0.53||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Impact of Event Scale-Revised Total Score (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-0.53|-1.08|<= 0.001
70921904|NCT04992390|141334084|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.95|||<=|0.001|TWO_SIDED|95.0|-1.27|-0.62||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Impact of Event Scale-Revised Intrusion Subscale (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-0.62|-1.27|<= 0.001
70921905|NCT04992390|141334084|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.75|||<=|0.001|TWO_SIDED|95.0|-1.09|-0.42||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Impact of Event Scale-Revised Avoidance Subscale (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-0.42|-1.09|<= 0.001
70921906|NCT04992390|141334084|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.7|||<=|0.001|TWO_SIDED|95.0|-0.97|-0.44||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Impact of Event Scale-Revised Hyperarousal Subscale (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-0.44|-0.97|<= 0.001
70921907|NCT04992390|141334085|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-2.29|||<=|0.001|TWO_SIDED|95.0|-3.52|-1.07||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for PTSD Checklist for DSM-5 (PCL-5) 4-item version (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons.(Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-1.07|-3.52|<= 0.001
71033772|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.57|||<|0.001|TWO_SIDED|95.0|2.7|4.44||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||4.44|2.70|<0.001
71033773|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.68|||<|0.001|TWO_SIDED|95.0|2.82|4.53||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||4.53|2.82|<0.001
71033774|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.72|||<|0.001|TWO_SIDED|95.0|1.87|3.57||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||3.57|1.87|<0.001
70975077|NCT04871711|141457013|SUPERIORITY||Risk Difference (RD)|9.3||||0.004|TWO_SIDED|95.0|3.8|14.7||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||14.7|3.8|0.004
70975078|NCT04871711|141457014|SUPERIORITY||Risk Difference (RD)|22.5|||<|0.001|TWO_SIDED|95.0|14.4|30.6||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||30.6|14.4|<0.001
70975079|NCT04871711|141457015|SUPERIORITY||Risk Difference (RD)|19.5|||<|0.001|TWO_SIDED|95.0|12.5|26.5||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||26.5|12.5|<0.001
70975080|NCT04871711|141457016|SUPERIORITY||Risk Difference (RD)|21.7|||<|0.001|TWO_SIDED|95.0|12.4|30.9||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||30.9|12.4|<0.001
70975081|NCT04871711|141457017|SUPERIORITY||Risk Difference (RD)|23.9|||<|0.001|TWO_SIDED|95.0|15.2|32.7||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||32.7|15.2|<0.001
70975082|NCT04871711|141457018|SUPERIORITY||Risk Difference (RD)|19.6|||<|0.001|TWO_SIDED|95.0|11.8|27.5||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||27.5|11.8|<0.001
70975083|NCT04871711|141457019|SUPERIORITY||Risk Difference (RD)|17.2|||<|0.001|TWO_SIDED|95.0|10.1|24.3||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||24.3|10.1|<0.001
71033775|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.13|||<|0.001|TWO_SIDED|95.0|3.27|4.99||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||4.99|3.27|<0.001
71033776|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.09|||<|0.001|TWO_SIDED|95.0|3.24|4.95||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||4.95|3.24|<0.001
71033777|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.09|||<|0.001|TWO_SIDED|95.0|2.24|3.93||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||3.93|2.24|<0.001
71033778|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.25|||<|0.001|TWO_SIDED|95.0|3.36|5.13||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||5.13|3.36|<0.001
71033779|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.04|||<|0.001|TWO_SIDED|95.0|3.17|4.92||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||4.92|3.17|<0.001
71033780|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.98|||<|0.001|TWO_SIDED|95.0|2.11|3.85||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||3.85|2.11|<0.001
71033781|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.07|||<|0.001|TWO_SIDED|95.0|3.14|5.01||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||5.01|3.14|<0.001
71033782|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|||<|0.001|TWO_SIDED|95.0|3.07|4.92||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||4.92|3.07|<0.001
71033783|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.83|||<|0.001|TWO_SIDED|95.0|1.91|3.75||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||3.75|1.91|<0.001
71033784|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75|||<|0.001|TWO_SIDED|95.0|2.78|4.71||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||4.71|2.78|<0.001
71033785|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.93|||<|0.001|TWO_SIDED|95.0|2.98|4.89||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||4.89|2.98|<0.001
71033786|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|||<|0.001|TWO_SIDED|95.0|1.85|3.75||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||3.75|1.85|<0.001
71154297|NCT00310180|141801194|SUPERIORITY|Since the noninferiority comparison is formulated using a conventional superiority null hypothesis described as above, a type II error corresponds to concluding that Arm B is not inferior when in fact it is. The design therefore uses a one-sided type I error of 10% and is planned to have 95% power (5% type II error). If the null hypothesis is rejected (at the one-sided 10% level), then it will be concluded that endocrine therapy alone is inferior to chemoendocrine therapy.|Hazard Ratio (HR)|1.08||||0.13|TWO_SIDED|95.0|0.94|1.24||One-sided p value for stratified Cox proportional hazard analysis, stratified on recurrence score, tumor size and menopausal status.|Regression, Cox|||This study uses a noninferiority design, but the noninferiority question is formulated using the conventional superiority null hypothesis of equal DFS on the two arms (that is, the null hypothesis is that Arm B is not inferior to Arm C). The alternative hypothesis is that Arm B has substantially worse DFS than Arm C, specified by a hazard ratio for B vs. C of 1.322.||1.24|0.94|0.13
71033787|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.61|||<|0.001|TWO_SIDED|95.0|2.65|4.56||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||4.56|2.65|<0.001
71154298|NCT00310180|141801198|OTHER|Treatment-by-Age and RS subset was performed via Cox proportional hazard analysis||||||0.004|||||||Regression, Cox|||Treatment interaction test was performed for the 9 age by RS subsets (3 groups for each, age groups \<=50 vs. 51-65 vs. 66-75; RS groups 0-10 vs. 11-25 vs. \>25) in patients randomized to arms B and C||||0.004
71008445|NCT02394028|141524819|SUPERIORITY||Difference in rate|11.3||||0.0088|TWO_SIDED|95.0|2.7|19.65||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||19.65|2.70|0.0088
71008446|NCT02394028|141524820|SUPERIORITY||Difference in rate|11.5||||0.0026|TWO_SIDED|95.0|4.11|18.83||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||18.83|4.11|0.0026
71154299|NCT03147287|141801205|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.62|TWO_SIDED|90.0|0.79|1.55||We reported two-sided p-values corresponding to two-sided α level of 0.10. The test statistic and p-value were taken from the Cox proportional hazards model score test.|Log Rank|The SAP intended stratified tests and models, however one stratum was only 9 patients making implementation of stratification questionable.|We checked the proportional hazards assumption by visually assessing the plot of log( log(survival)) vs log of survival times according to treatment assignment for parallelism. This was done overall and according to stratum.|The primary objective was investigated by comparing the PFS distributions between two treatment arms using a logrank test with one-sided α level of 0.05 (H0: PFS1≤PFS2; HA: PFS1\>PFS2). Hazard ratios were estimated from a Cox PH model (F+P / F, so that HR\<1 indicates reduced hazard of PFS event with F+P), with two sided 90% CIs (Wald) to align with the design and testing.||1.55|0.79|0.62
71154300|NCT03147287|141801206|SUPERIORITY|||||||1||||||P-value is two sided, for hypothesis test with two-sided α=0.10|Fisher Exact|||The objective response was reported with two-sided 90% CI and compared between two treatment arms using a (unstratified) Fisher's exact test;||||1.000
70921908|NCT04992390|141334086|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|5.38|||<=|0.001|TWO_SIDED|95.0|2.56|8.2||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Sleep Condition Indicator (SCI) (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|8.20|2.56|<= 0.001
71033788|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.84|||<|0.001|TWO_SIDED|95.0|2.89|4.79||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||4.79|2.89|<0.001
70921909|NCT04992390|141334087|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.93|||<=|0.05|TWO_SIDED|95.0|-1.68|-0.17||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Generalised Anxiety Disorder 2-item scale (GAD-2) (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-0.17|-1.68|<=0.05
70921910|NCT04992390|141334088|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.52|||>|0.05|TWO_SIDED|95.0|-1.23|0.19||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Patient Health Questionnaire 2-item version (PHQ-2) (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons.(Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|0.19|-1.23|> .05
70921911|NCT04992390|141334089|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-6.49|||<=|0.001|TWO_SIDED|95.0|-8.48|-4.51||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Psychological Outcome Profiles (PSYCHLOPS) (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-4.51|-8.48|<= 0.001
70921912|NCT04992390|141334090|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-9.78|||<=|0.001|TWO_SIDED|95.0|-15.06|-4.5||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for World Health Organization Disability Assessment Schedule 12-item version (WHODAS 2.0) (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-4.50|-15.06|<= 0.001
70921913|NCT04992390|141334091|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|12.32|||<=|0.01|TWO_SIDED|95.0|4.61|20.04||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for 5-level European Quality of Life 5 Dimension (EQ-5D-5L) (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 for EQ-5D-5L subscale comparisons and Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|20.04|4.61|<= 0.01
71033789|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6|||<|0.001|TWO_SIDED|95.0|1.65|3.54||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||3.54|1.65|<0.001
71033790|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.54|||<|0.001|TWO_SIDED|95.0|2.54|4.53||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||4.53|2.54|<0.001
71033791|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.51|||<|0.001|TWO_SIDED|95.0|2.52|4.49||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||4.49|2.52|<0.001
71008447|NCT02394028|141524822|SUPERIORITY||Difference in rate|3.1||||1|TWO_SIDED|95.0|-8.02|13.45||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates are adjusted using CMH weights and the 95% CIs use the Newcombes method.|||13.45|-8.02|1
71008448|NCT02394028|141524822|SUPERIORITY||Difference in rate|2.3||||0.7908|TWO_SIDED|95.0|-8.78|12.56||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates are adjusted using CMH weights and the 95% CIs use the Newcombes method.|||12.56|-8.78|0.7908
71008449|NCT02394028|141524824|SUPERIORITY||Difference in rate|1.6||||1|TWO_SIDED|95.0|-6.51|9.73||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates are adjusted using CMH weights and the 95% CIs use the Newcombes method.|||9.73|-6.51|1
71008450|NCT02394028|141524824|SUPERIORITY||Difference in rate|6.5||||0.5235|TWO_SIDED|95.0|-2.24|15.16||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates are adjusted using CMH weights and the 95% CIs use the Newcombes method.|||15.16|-2.24|0.5235
71008451|NCT02394028|141524825|SUPERIORITY||Difference in LSM|-0.5||||0.311|TWO_SIDED|90.0|-1.4|0.3|||MMRM|||Bowel Domain Score||0.3|-1.4|0.3110
71008452|NCT02394028|141524826|SUPERIORITY||Difference in LSM|0.2||||1|TWO_SIDED|95.0|-0.5|0.9||The multiplicity adjusted p-values are presented.|MMRM|||Functional Domain Scale||0.9|-0.5|1
71008453|NCT02394028|141524826|SUPERIORITY||Difference in LSM|0.0||||1|TWO_SIDED|95.0|-0.7|0.7||The multiplicity adjusted p-values are presented.|MMRM|||Functional Domain Score||0.7|-0.7|1
71008454|NCT02394028|141524826|SUPERIORITY||Difference in LSM|0.1||||1|TWO_SIDED|95.0|-0.8|0.9||The multiplicity adjusted p-values are presented.|MMRM|||Bowel Domain Score||0.9|-0.8|1
71008455|NCT02394028|141524826|SUPERIORITY||Difference in LSM|-0.3||||1|TWO_SIDED|95.0|-1.1|0.5||The multiplicity adjusted p-values are presented.|MMRM|||Bowel Domain Score||0.5|-1.1|1
71008456|NCT02394028|141524827|SUPERIORITY||Difference in rate|17.3||||0.0677|TWO_SIDED|95.0|3.52|30.27||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||30.27|3.52|0.0677
71008457|NCT02394028|141524828|SUPERIORITY||Difference in rates|18.6||||0.048|TWO_SIDED|95.0|11.07|25.96||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||25.96|11.07|0.0480
71008458|NCT02394028|141524829|SUPERIORITY||Difference in rates|13.5||||0.121|TWO_SIDED|95.0|-2.9|29.94|||Cochran-Mantel-Haenszel||Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||29.94|-2.90|0.1210
71008459|NCT02394028|141524830|SUPERIORITY||Difference in rates|6.2||||0.048|TWO_SIDED|95.0|0.54|11.93||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||11.93|0.54|0.0480
71008460|NCT02394028|141524831|SUPERIORITY||Difference in rates|11.2||||0.0677|TWO_SIDED|95.0|3.04|19.24||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||19.24|3.04|0.0677
71008461|NCT02394028|141524832|SUPERIORITY||Difference in rates|16.2||||0.0035|TWO_SIDED|95.0|8.96|23.31||Nominal p-value, no adjustment for multiplicity performed.|Cochran-Mantel-Haenszel||Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||23.31|8.96|0.0035
71008462|NCT02394028|141524833|SUPERIORITY||Difference in LSM|-0.3||||0.4009|TWO_SIDED|95.0|-0.9|0.4||The multiplicity adjusted p-values are presented.|MMRM|||Functional Symptoms Domain||0.4|-0.9|0.4009
71008463|NCT02394028|141524833|SUPERIORITY||Difference in LSM|-0.3||||0.4009|TWO_SIDED|95.0|-1.0|0.4||The multiplicity adjusted p-values are presented.|MMRM|||Bowel Symptoms Domain||0.4|-1.0|0.4009
71008464|NCT01981096|141524852|SUPERIORITY|||||||0.011||||||The a priori threshold was alpha = .05.|ANCOVA|Adjusted for age and baseline pain levels||This analysis represents the between group comparisons (i.e., FIT Teens vs. CBT) from baseline assessment to the 3-month follow-up, the primary endpoint of the trial.||||.011
71008465|NCT01981096|141524853|SUPERIORITY|||||||0.055||||||The a priori threshold was alpha = .05.|ANCOVA|Adjusted for age and baseline pain levels||This analysis represents the between group comparisons (i.e., FIT Teens vs. CBT) from baseline assessment to the 3-month follow-up, the primary endpoint of the trial.||||.055
71008466|NCT01225211|141524858|SUPERIORITY_OR_OTHER||LS Mean difference|-2.679||||0.267|TWO_SIDED|95.0|-7.484|2.125|||ANCOVA|||||2.125|-7.484|0.267
71095651|NCT00447278|141699636|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.7||||0.54|TWO_SIDED|95.0|-2.98|1.58||P-value for Risk Avoidance Change: 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||1.58|-2.98|0.540
70921914|NCT04992390|141334092|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|0.46|||<=|0.001|TWO_SIDED|95.0|0.2|0.71||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Scale of Work Engagement and Burnout (SWEBO) - Work Engagement Subscale (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|0.71|0.20|<= 0.001
70975084|NCT04871711|141457020|SUPERIORITY||Risk Difference (RD)|25.7|||<|0.001|TWO_SIDED|95.0|17.2|34.3||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||34.3|17.2|<0.001
70975085|NCT04871711|141457021|SUPERIORITY||Risk Difference (RD)|24.2|||<|0.001|TWO_SIDED|95.0|15.5|33.0||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||33.0|15.5|<0.001
70975086|NCT04871711|141457022|SUPERIORITY||Mean Difference (Net)|-35.2|||<|0.001|TWO_SIDED|95.0|-46.7|-23.8||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HECSI score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-23.8|-46.7|<0.001
70975087|NCT04871711|141457023|SUPERIORITY||Mean Difference (Net)|-3.6|||<|0.001|TWO_SIDED|95.0|-4.7|-2.6||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline DLQI score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-2.6|-4.7|<0.001
70975088|NCT04871711|141457024|SUPERIORITY||Mean Difference (Net)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.2|-1.2||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HESD score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-1.2|-2.2|<0.001
70975089|NCT04871711|141457025|SUPERIORITY||Mean Difference (Net)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.3|-1.2||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HESD itch score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-1.2|-2.3|<0.001
70975090|NCT04871711|141457026|SUPERIORITY||Mean Difference (Net)|-1.6|||<|0.001|TWO_SIDED|95.0|-2.1|-1.0||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HESD pain score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-1.0|-2.1|<0.001
71008467|NCT01225211|141524858|SUPERIORITY_OR_OTHER||LS Mean difference|-9.676|||<|0.001|TWO_SIDED|95.0|-14.801|-4.551|||ANCOVA|||||-4.551|-14.801|<0.001
71008468|NCT01225211|141524859|SUPERIORITY_OR_OTHER||LS Mean difference|-1.306||||0.68|TWO_SIDED|95.0|-7.565|4.953|||ANCOVA|||||4.953|-7.565|0.680
71008469|NCT01225211|141524859|SUPERIORITY_OR_OTHER||LS Mean difference|-2.67||||0.409|TWO_SIDED|95.0|-9.053|3.712|||ANCOVA|||||3.712|-9.053|0.409
71008470|NCT01225211|141524859|SUPERIORITY_OR_OTHER||LS Mean difference|-4.526||||0.161|TWO_SIDED|95.0|-10.888|1.835|||ANCOVA|||||1.835|-10.888|0.161
71095652|NCT00447278|141699636|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.98||||0.106|TWO_SIDED|95.0|-4.4|0.44||P-value for Risk Avoidance Change: 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.44|-4.40|0.106
71095653|NCT00447278|141699636|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.3||||0.833|TWO_SIDED|95.0|-2.49|3.08||P-value for Resilience Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||3.08|-2.49|0.833
71095654|NCT00447278|141699636|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.34||||0.11|TWO_SIDED|95.0|-5.21|0.54||P-value for Resilience Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.54|-5.21|0.110
71095655|NCT02810327|141699661|OTHER|||||||0.054|||||||Wilcoxon (Mann-Whitney)|||The MUSC Bioinformatics Core analyzed group genomic data for variant association with COPD severity score, including single variant association or type of variant association with symptoms. Descriptive statistical analysis was performed using statistical package SAS 9.4 for Windows (SAS Institute Inc., Cary, NC, USA).||||0.054
70975091|NCT04871711|141457027|SUPERIORITY||Mean Difference (Net)|-0.64|||<|0.001|TWO_SIDED|95.0|-0.83|-0.45||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HEIS score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-0.45|-0.83|<0.001
70975092|NCT04871711|141457028|SUPERIORITY||Mean Difference (Net)|-0.6|||<|0.001|TWO_SIDED|95.0|-0.79|-0.4||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HEIS PDAL score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-0.40|-0.79|<0.001
70975093|NCT04871711|141457029|SUPERIORITY||Risk Difference (RD)|24.5|||<|0.001|TWO_SIDED|95.0|15.0|33.9||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||33.9|15.0|<0.001
70975094|NCT00535925|141457031|OTHER||Cox Proportional Hazard|0.48|||<|0.05|TWO_SIDED||||||Regression, Cox|Cox Shared Frailty Model, adjusted for age, sex, SBP, Hb, eGFR, albuminuria, HbA1c, total cholesterol, triglycerides (log-scaled) to reduce bias risk.||||||<0.05
70975095|NCT03551743|141457082|SUPERIORITY||Least Squares Means (Difference)|-65.02||||0.0344|TWO_SIDED||||||ANCOVA|||||||0.0344
70975096|NCT03551743|141457082|SUPERIORITY||Least Squares Means (Difference)|-92.38||||0.0014|TWO_SIDED||||||ANCOVA|||||||0.0014
70975097|NCT03551743|141457082|SUPERIORITY||Least Squares Means (Difference)|-46.26||||0.0002|TWO_SIDED||||||ANCOVA|||||||0.0002
70975098|NCT03551743|141457083|SUPERIORITY||Least Squares Means (Difference)|88722.37||||0.0032|TWO_SIDED||||||ANCOVA|||||||0.0032
70975099|NCT03551743|141457083|SUPERIORITY||Least Squares Means (Difference)|151500.3||||0.0003|TWO_SIDED||||||ANCOVA|||||||0.0003
70975100|NCT03551743|141457083|SUPERIORITY||Least Squares Means (Difference)|198560.4||||0.0004|TWO_SIDED||||||ANCOVA|||||||0.0004
70975101|NCT03551743|141457084|SUPERIORITY||Least Squares Means (Difference)|-76.05||||0.1874|TWO_SIDED||||||ANCOVA|||||||0.1874
70975102|NCT03551743|141457084|SUPERIORITY||Least Squares Means (Difference)|-27.98||||0.386|TWO_SIDED||||||ANCOVA|||||||0.386
70975103|NCT03551743|141457084|SUPERIORITY||Least Squares Means (Difference)|-49.99|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
70975104|NCT01493180|141457093|SUPERIORITY_OR_OTHER|||||||0.576|||||||t-test, 2 sided|||||||0.576
70975105|NCT03179436|141457100|OTHER||Percent Difference|2.4|||||TWO_SIDED|95.0|-8.7|14.1|||Percent Difference|Comparision based on Miettinen \& Nurminen method||||14.1|-8.7|
70975106|NCT00762515|141457130|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|baseline is used a factor||The null hypothesis states that there is no difference between groups.||||<0.05
70975107|NCT00762515|141457131|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|baseline to be used a factor||The null hypothesis states that there is no difference between groups.||||<0.05
70975108|NCT02851173|141457141|OTHER|||||||0.79|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. CU group.||||0.79
70975109|NCT02851173|141457141|OTHER|||||||0.87|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. MCI group.||||0.87
70975110|NCT02851173|141457141|OTHER|||||||0.16|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. CU group. 3 outliers removed, whose scores were outside 1.5 times the interquartile range.||||0.16
70975111|NCT02851173|141457142|OTHER|||||||0.22|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Left middle frontal gyrus 1.||||0.22
70975112|NCT02851173|141457142|OTHER|||||||0.69|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Left medial frontal/superior frontal gyrus.||||0.69
70975113|NCT02851173|141457142|OTHER|||||||0.25|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Right superior parietal lobule.||||0.25
70975114|NCT02851173|141457142|OTHER|||||||0.86|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Left inferior parietal lobule.||||0.86
70975115|NCT02851173|141457142|OTHER|||||||0.28|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Left middle frontal gyrus 2.||||0.28
70975116|NCT02851173|141457142|OTHER|||||||0.12|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Right superior frontal gyrus.||||0.12
70975117|NCT02851173|141457142|OTHER|||||||0.26|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Right middle frontal gyrus.||||0.26
70975118|NCT02851173|141457142|OTHER|||||||0.83|||||||ANOVA|||The contract of interest was the Time x Treatment Group interaction. Right inferior frontal gyrus.||||0.83
70975119|NCT02851173|141457142|OTHER|||||||0.55|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Left middle frontal gyrus 1.||||0.55
71095656|NCT02384460|141699697|OTHER||Hazard Ratio (HR)|1.004||||0.985|TWO_SIDED|95.0|0.651|1.549||p-value is for Type 3 chi-square test for comparison between treatments.|Cox Model Analysis|||Cox proportional hazards model compares treatment groups with baseline target wound size, target wound age, and EB type as covariates.||1.549|0.651|0.985
71095657|NCT02384460|141699698|OTHER|Multiple imputation was implemented by 2 steps. The first step used Markov Chain Monte Carlo (MCMC) to get monotonic missing data pattern. In the second step, a logistic regression model was used, with the following covariates included in the imputation model: treatment, EB type, baseline target wound size, target wound age, and non-missing data from earlier time points. The seed number was 010005 and the number of imputations was 5.|Odds Ratio (OR)|0.733||||0.39|TWO_SIDED|95.0|0.365|1.474||p-value is from the logistic regression model for treatment comparison.|Regression, Logistic|||Comparison between treatment groups of complete closure of target wound within 3 months was performed using a logistic regression model with multiple imputation with EB type, baseline target wound size, and baseline target wound age as covariates.||1.474|0.365|0.39
70975120|NCT02851173|141457142|OTHER|||||||0.76|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Left medial frontal/superior frontal gyrus.||||0.76
70975121|NCT02851173|141457142|OTHER|||||||0.38|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Right superior parietal lobule.||||0.38
70975122|NCT02851173|141457142|OTHER|||||||0.93|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Left inferior parietal lobule.||||0.93
70975123|NCT02851173|141457142|OTHER|||||||0.41|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Left middle frontal gyrus 2.||||0.41
70975124|NCT02851173|141457142|OTHER|||||||0.06|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Right superior frontal gyrus.||||0.06
70975125|NCT02851173|141457142|OTHER|||||||0.18|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Right middle frontal gyrus.||||0.18
71008471|NCT01225211|141524859|SUPERIORITY_OR_OTHER||LS Mean difference|-2.867||||0.396|TWO_SIDED|95.0|-9.543|3.81|||ANCOVA|||||3.810|-9.543|0.396
71008472|NCT01225211|141524859|SUPERIORITY_OR_OTHER||LS Mean difference|-3.78||||0.365|TWO_SIDED|95.0|-12.028|4.467|||ANCOVA|||||4.467|-12.028|0.365
71008473|NCT01225211|141524860|SUPERIORITY_OR_OTHER||LS Mean difference|0.6||||0.5978|TWO_SIDED|95.0|-1.66|2.86|||Mixed Model Repeated Measure (MMRM)|||||2.86|-1.66|0.5978
71008474|NCT01241318|141524878|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.12|||||TWO_SIDED|95.0|0.88|1.44|||||The chlorhexidine arm is the numerator and dry cord care arm is the denominator in the relative risk calculation. Generalised estimating equation models were used to adjust for cluster randomized design.|||1.44|0.88|
71008475|NCT01241318|141524879|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.12|||||TWO_SIDED|95.0|0.86|1.47|||||Generalized estimating equation models adjusting for cluster-randomized design were used.|||1.47|0.86|
71008476|NCT01241318|141524880|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.47|1.13|||||Generalized estimating equation models adjusting for cluster-randomized design were used.|||1.13|0.47|
71008477|NCT02355665|141524885|SUPERIORITY||Estimated Success Rate Ratio|2.0||||0.021|TWO_SIDED|95.0|1.1|3.66||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||3.66|1.10|0.021
71008478|NCT02355665|141524886|SUPERIORITY||Estimated Success Rate Ratio|3.04||||0.004|TWO_SIDED|95.0|1.39|6.68||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||6.68|1.39|0.004
71008479|NCT02355665|141524887|SUPERIORITY||Estimated Success Rate Ratio|2.87||||0.011|TWO_SIDED|95.0|1.23|6.71||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||6.71|1.23|0.011
71008480|NCT02355665|141524888|SUPERIORITY||Estimated Success Rate Ratio|1.66||||0.04|TWO_SIDED|95.0|1.02|2.71||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||2.71|1.02|0.040
71008481|NCT02355665|141524889|SUPERIORITY||Estimated Success Rate Ratio|2.09||||0.023|TWO_SIDED|95.0|1.09|3.98||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||3.98|1.09|0.023
71033792|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.67|||<|0.001|TWO_SIDED|95.0|1.69|3.65||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||3.65|1.69|<0.001
71095658|NCT02384460|141699699|OTHER|Multiple imputation was implemented by 2 steps. The first step used MCMC to get the monotonic missing data pattern. In the second step, a logistic regression model was used, with the following covariates included in the imputation method: treatment, EB type, baseline target wound size, target wound age, and non-missing data from earlier time points. The seed number was 01005 and the number of imputations was 5.|Odds Ratio (OR)|1.633||||0.212|TWO_SIDED|95.0|0.758|3.517||p-value is from the logistic regression model for treatment comparison.|Regression, Logistic|||Logistic Regression Analysis at Month 1 visit. Comparison between treatment groups of complete closure of target wound within 1 month was performed using a logistic regression model with multiple imputation with EB type, baseline target wound size, and baseline target wound age as covariates.||3.517|0.758|0.212
71033793|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2|||<|0.001|TWO_SIDED|95.0|2.19|4.21||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||4.21|2.19|<0.001
71033794|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.51|||<|0.001|TWO_SIDED|95.0|2.51|4.51||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||4.51|2.51|<0.001
71033795|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.49|||<|0.001|TWO_SIDED|95.0|1.49|3.48||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||3.48|1.49|<0.001
71033796|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.19|||<|0.001|TWO_SIDED|95.0|2.17|4.21||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||4.21|2.17|<0.001
71033797|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.65|||<|0.001|TWO_SIDED|95.0|2.64|4.66||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||4.66|2.64|<0.001
71033798|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.59|||<|0.001|TWO_SIDED|95.0|1.58|3.6||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||3.60|1.58|<0.001
71033799|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|||<|0.001|TWO_SIDED|95.0|2.06|4.15||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||4.15|2.06|<0.001
71033800|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.57|||<|0.001|TWO_SIDED|95.0|2.53|4.61||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||4.61|2.53|<0.001
71033801|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.64|||<|0.001|TWO_SIDED|95.0|1.61|3.67||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||3.67|1.61|<0.001
71033802|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.15|||<|0.001|TWO_SIDED|95.0|2.09|4.21||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||4.21|2.09|<0.001
71033803|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.41|||<|0.001|TWO_SIDED|95.0|2.36|4.46||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||4.46|2.36|<0.001
71033804|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|||<|0.001|TWO_SIDED|95.0|1.36|3.44||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||3.44|1.36|<0.001
71033805|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.03|||<|0.001|TWO_SIDED|95.0|1.94|4.12||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||4.12|1.94|<0.001
71033806|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.99|||<|0.001|TWO_SIDED|95.0|1.91|4.07||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||4.07|1.91|<0.001
71033807|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.35|||<|0.001|TWO_SIDED|95.0|1.28|3.42||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||3.42|1.28|<0.001
71033808|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|||<|0.001|TWO_SIDED|95.0|1.57|3.83||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||3.83|1.57|<0.001
71033809|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.74|||<|0.001|TWO_SIDED|95.0|1.62|3.85||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||3.85|1.62|<0.001
71033810|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.26|||<|0.001|TWO_SIDED|95.0|1.14|3.37||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||3.37|1.14|<0.001
71033811|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.64|||<|0.001|TWO_SIDED|95.0|1.51|3.76||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||3.76|1.51|<0.001
71033812|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.45|||<|0.001|TWO_SIDED|95.0|1.33|3.56||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||3.56|1.33|<0.001
71033813|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.36|||<|0.001|TWO_SIDED|95.0|1.25|3.47||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||3.47|1.25|<0.001
71033814|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.02|||<|0.001|TWO_SIDED|95.0|0.86|3.19||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||3.19|0.86|<0.001
71033815|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9||||0.001|TWO_SIDED|95.0|0.75|3.05||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||3.05|0.75|0.001
71033816|NCT00913627|141577231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.19|||<|0.001|TWO_SIDED|95.0|1.05|3.34||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||3.34|1.05|<0.001
71033817|NCT00913627|141577232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.42|||<|0.001|TWO_SIDED|95.0|1.94|2.89||p-value adjusted for baseline PSR and gender|ANOVA|||||2.89|1.94|<0.001
71033818|NCT00913627|141577232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.39|||<|0.001|TWO_SIDED|95.0|1.92|2.86||p-value adjusted for baseline PSR and gender|ANOVA|||||2.86|1.92|<0.001
71033819|NCT00913627|141577232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.05|||<|0.001|TWO_SIDED|95.0|1.58|2.52||p-value adjusted for baseline PSR and gender|ANOVA|||||2.52|1.58|<0.001
70921915|NCT04992390|141334092|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.61|||<=|0.001|TWO_SIDED|95.0|-0.87|-0.34||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Scale of Work Engagement and Burnout (SWEBO) - Work Burnout Subscale (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-0.34|-0.87|<= 0.001
70921916|NCT04992390|141334093|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Incidence Rate Ratio|1.5|||>|0.05|TWO_SIDED|95.0|0.64|3.51||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Poisson|||ITT analysis for Sickness absence (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|3.51|0.64|> .05
70921917|NCT04992390|141334094|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.86|||>|0.05|TWO_SIDED|95.0|-2.2|0.49||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Intention to leave job (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|0.49|-2.20|> .05
70921918|NCT04992390|141334095|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Incidence Rate Ratio|0.8|||>|0.05|TWO_SIDED|95.0|0.6|1.07||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Poisson|||ITT analysis for number of days worked (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|1.07|0.60|>.05
70921919|NCT04992390|141334096|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Incidence Rate Ratio|1.09|||<|0.05|TWO_SIDED|95.0|0.57|2.09||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Poisson|||ITT analysis for number of nights worked (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|2.09|0.57|<.05
70921920|NCT03725722|141334125|SUPERIORITY||||||<|0.0001||||||"P-values were adjusted for multiple comparisons. Models with adjusted p-value of \<0.025 were stat. sign. diff. from a flat dose-response model.~Model selected: Sigmoid Emax model"|Multiple contrast test|||The primary endpoint was evaluated by determining if there was a dose-response relationship between the change from baseline to Week 8 in EASI score and the dose administered using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed and multiple comparison techniques were used to choose the model(s) likely to present the true underlying dose-response curve.||||<0.0001
70921921|NCT03725722|141334125|SUPERIORITY||Mean Difference (Net)|-3.1|||<|0.01|TWO_SIDED|95.0|-5.0|-1.3||The stat. test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. were excluded from the analysis. Likewise for missing data due to COVID-19 pandemic.|Mixed Models Analysis|||"Least square (LS) means were calculated using a mixed model response model (MMRM) on post-baseline responses up to Week 8 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom and the mean modelled as follows:~Change from baseline in EASI = treatment x visit + baseline EASI x visit + region + baseline vIGA-AD.~The primary comparison between each active delgocitinib dose and delgocitinib cream vehicle was at Week 8."||-1.3|-5.0|<0.01
70975126|NCT02851173|141457142|OTHER|||||||0.84|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Right inferior frontal gyrus.||||0.84
70975127|NCT02851173|141457143|OTHER|||||||0.53|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction.||||0.53
70975128|NCT02851173|141457143|OTHER|||||||0.74|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy).||||0.74
71095659|NCT02384460|141699699|OTHER|Multiple imputation was implemented by 2 steps. The first step used MCMC to get monotonic missing data pattern. In the second step, a logistic regression model was used, with the following covariates included in the imputation model: treatment, EB type, baseline target wound size, target wound age, and non-missing data from earlier time points. The seed number was 01005 and the number of imputations was 5.|Odds Ratio (OR)|0.891||||0.802|TWO_SIDED|95.0|0.436|1.821||p-value is from the logistic regression model for treatment comparison.|Regression, Logistic|||Logistic Regression Analysis at Month 2 visit. Comparison between treatment groups of complete closure of target wound within 2 months was performed using a logistic regression model with multiple imputation with EB type, baseline target wound size, and baseline target wound age as covariates.||1.821|0.436|0.802
70921922|NCT03725722|141334125|SUPERIORITY||Mean Difference (Net)|-3.0|||<|0.05|TWO_SIDED|95.0|-4.8|-1.2||The stat. test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. were excluded from the analysis. Likewise for missing data due to COVID-19 pandemic.|Mixed Models Analysis|||"Least square (LS) means were calculated using a mixed model response model (MMRM) on post-baseline responses up to Week 8 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom and the mean modelled as follows:~Change from baseline in EASI = treatment x visit + baseline EASI x visit + region + baseline vIGA-AD.~The primary comparison between each active delgocitinib dose and delgocitinib cream vehicle was at Week 8."||-1.2|-4.8|<0.05
70921923|NCT03725722|141334125|SUPERIORITY||Mean Difference (Net)|-4.0|||<|0.0001|TWO_SIDED|95.0|-5.8|-2.1||The stat. test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. were excluded from the analysis. Likewise for missing data due to COVID-19 pandemic.|Mixed Models Analysis|||"Least square (LS) means were calculated using a mixed model response model (MMRM) on post-baseline responses up to Week 8 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom and the mean modelled as follows:~Change from baseline in EASI = treatment x visit + baseline EASI x visit + region + baseline vIGA-AD.~The primary comparison between each active delgocitinib dose and delgocitinib cream vehicle was at Week 8."||-2.1|-5.8|<0.0001
70921924|NCT03725722|141334125|SUPERIORITY||Median Difference (Net)|-5.7|||<|0.0001|TWO_SIDED|95.0|-7.5|-3.9||The stat. test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. were excluded from the analysis. Likewise for missing data due to COVID-19 pandemic.|Mixed Models Analysis|||"Least square (LS) means were calculated using a mixed model response model (MMRM) on post-baseline responses up to Week 8 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom and the mean modelled as follows:~Change from baseline in EASI = treatment x visit + baseline EASI x visit + region + baseline vIGA-AD.~The primary comparison between each active delgocitinib dose and delgocitinib cream vehicle was at Week 8."||-3.9|-7.5|<0.0001
70921925|NCT03725722|141334126|SUPERIORITY||||||<|0.0001||||||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Multiple contrast test|"P-values adj. for multiple comparisons. Models with adj. p-value \<0.025 were stat. sign. diff. from a flat dose-response model.~Model: Linear model"||This endpoint was evaluated by determining if there was a dose-response relationship between the vIGA-AD response rate at Week 8 and the dose administered using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed and multiple comparison techniques were used to choose the model(s) most likely to represent the true underlying dose-response.||||<0.0001
70921926|NCT03725722|141334126|SUPERIORITY||Risk Difference (RD)|8.2|||>|0.05|TWO_SIDED|95.0|-5.6|21.9||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference.||21.9|-5.6|>0.05
70975129|NCT02851173|141457144|OTHER|||||||0.72|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction.||||0.72
70975130|NCT02851173|141457144|OTHER|||||||0.97|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy).||||0.97
70975131|NCT01582308|141457156|SUPERIORITY_OR_OTHER||Least squares mean difference|18.24|||<|0.001|TWO_SIDED|90.0|14.97|21.67||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||21.67|14.97|<.001
70975132|NCT01582308|141457156|SUPERIORITY_OR_OTHER||Least squares mean difference|62.86|||<|0.001|TWO_SIDED|90.0|58.21|67.74||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||67.74|58.21|<.001
71095660|NCT02384460|141699700|OTHER|Multiple imputation was used by 2 steps. The first step used MCMC to get monotonic missing data pattern. In the second step, a linear regression model was used, with the following covariates included in the imputation model: treatment, EB type, baseline BSAI of lesional skin, and non-missing data from earlier time points. The seed number was 01005 and the number of imputations was 5.|LS means difference|0.682||||0.706|TWO_SIDED|95.0|-2.873|4.238||The p-value is calculated based on the hypothesis testing for the difference of least-squares (LS)-means between treatment and placebo.|Mixed Models Analysis|||Mixed Model Repeated Measures (MMRM) Analysis. The MMRM approach (using restricted maximum likelihood \[REML\] estimation) was used on each multiply-imputed data set. The model included treatment, baseline BSAI of lesional skin, EB type, visit, and visit-treatment interaction as the fixed effects.||4.238|-2.873|0.706
70921927|NCT03725722|141334126|SUPERIORITY||Risk Difference (RD)|19.3|||<|0.05|TWO_SIDED|95.0|3.9|34.6||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference.||34.6|3.9|<0.05
70921928|NCT03725722|141334126|SUPERIORITY||Risk Difference (RD)|20.3|||<|0.05|TWO_SIDED|95.0|5.4|35.2||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference||35.2|5.4|<0.05
70921929|NCT03725722|141334126|SUPERIORITY||Risk Difference (RD)|38.3|||<|0.0001|TWO_SIDED|95.0|22.3|54.3||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference||54.3|22.3|<0.0001
70921930|NCT03725722|141334127|SUPERIORITY||||||<|0.0001||||||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Multiple contrast test|"P-values were adj. for multiple comparisons. Models with adj. p-value \<0.025 were stat. sign. diff. from a flat dose-response model.~Model:Emax model"||This endpoint was evaluated by determining if there was a dose-response relationship between EASI75 at Week 8 and the dose administered using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed and multiple comparison techniques were used to choose the model(s) most likely to represent the true underlying dose-response||||<0.0001
70975133|NCT01582308|141457156|SUPERIORITY_OR_OTHER||Least squares mean difference|1.11||||0.128|TWO_SIDED|90.0|-0.1|2.33||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||2.33|-0.10|0.128
70975134|NCT01582308|141457156|SUPERIORITY_OR_OTHER||Least squares mean difference|88.24|||<|0.001|TWO_SIDED|90.0|85.77|90.76||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||90.76|85.77|<.001
70975135|NCT01582308|141457156|SUPERIORITY_OR_OTHER||Least squares mean difference|44.62|||<|0.001|TWO_SIDED|90.0|34.51|55.23||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||55.23|34.51|<.001
70975136|NCT01582308|141457156|SUPERIORITY_OR_OTHER||Least squares mean difference|-17.13|||<|0.001|TWO_SIDED|90.0|-21.21|-13.25||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||-13.25|-21.21|<.001
70975137|NCT01582308|141457156|SUPERIORITY_OR_OTHER||Least squares mean difference|70.0|||<|0.001|TWO_SIDED|90.0|58.46|82.2||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||82.20|58.46|<.001
70975138|NCT01582308|141457156|SUPERIORITY_OR_OTHER||Least squares mean difference|-61.75|||<|0.001|TWO_SIDED|90.0|-68.76|-55.18||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||-55.18|-68.76|<.001
70975139|NCT01582308|141457156|SUPERIORITY_OR_OTHER||Least squares mean difference|25.38|||<|0.001|TWO_SIDED|90.0|15.37|35.48||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||35.48|15.37|<.001
70975140|NCT01582308|141457156|SUPERIORITY_OR_OTHER||Least squares mean difference|87.13|||<|0.001|TWO_SIDED|90.0|80.06|94.61||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||94.61|80.06|<.001
70975141|NCT01641939|141457279|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.8589|TWO_SIDED|95.0|0.87|1.6||One sided p-value with correction for interim treatment selection due to adaptive seamless phase design.|Log Rank|Log-Rank test, inverse normal combination test.||The unstratified Cox proportional hazards model was used to estimate the hazard ratio. The 95% Confidence Interval (CI) for median was computed using the method of Brookmeyer and Crowley. Reference group: Standard Taxane Therapy.||1.60|0.87|0.8589
70975142|NCT01641939|141457280|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.32|2.03||||||The unstratified Cox proportional hazards model was used to estimate the hazard ratio. The 95% CI for median was computed using the method of Brookmeyer and Crowley. Reference group: Standard Taxane Therapy.||2.03|0.32|
70975143|NCT01641939|141457280|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.01|||||TWO_SIDED|95.0|0.82|4.92||||||The unstratified Cox proportional hazards model was used to estimate the hazard ratio. The 95% CI for median was computed using the method of Brookmeyer and Crowley. Reference group: Standard Taxane Therapy.||4.92|0.82|
70975144|NCT01641939|141457280|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.23|0.96||||||The unstratified Cox proportional hazards model was used to estimate the hazard ratio. The 95% CI for median was computed using the method of Brookmeyer and Crowley. Reference group: Trastuzumab Emtansine 3.6 mg||0.96|0.23|
70975145|NCT01641939|141457282|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.308|TWO_SIDED|95.0|0.89|1.43|||Log Rank|||The unstratified Cox proportional hazards model was used to estimate the hazard ratio. The 95% CI for median was computed using the method of Brookmeyer and Crowley. Reference group: Standard Taxane Therapy||1.43|0.89|0.308
70975146|NCT00122135|141457340|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||t-test, 2 sided|||||||.77
71033820|NCT03123471|141577233|SUPERIORITY||Difference in Response|29.6|||<|0.0001|TWO_SIDED|95.0|19.5|39.7|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||39.7|19.5|< 0.0001
71033821|NCT03123471|141577234|SUPERIORITY||Difference in Response|23.0|||<|0.0001|TWO_SIDED|95.0|11.5|34.6|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||34.6|11.5|< 0.0001
71095661|NCT02384460|141699701|OTHER|Multiple imputation was used by 2 steps. The first step used MCMC to get monotonic missing data pattern. In the second step, a linear regression model was used, with the following covariates included in the imputation model: treatment, EB type, baseline BSAI of lesional skin, and non-missing data from earlier time points. The seed number was 01005 and the number of imputations was 5.|LS means difference|0.128||||0.9|TWO_SIDED|95.0|-2.116|1.861||The p-value is calculated based on the hypothesis testing for the difference of LS-means between treatment and placebo.|Mixed Models Analysis|||MMRM Analysis. The MMRM approach (using REML estimation) was used on each multiply-imputed data set. The model included treatment, baseline BSAI of lesional skin, EB type, visit, and visit-treatment interaction as the fixed effects.||1.861|-2.116|0.9
71095662|NCT02384460|141699702|OTHER|Pre-specified.|Odds Ratio (OR)|1.445||||0.262|TWO_SIDED|95.0|0.759|2.752||p-value is from the logistic regression model for treatment comparison.|Regression, Logistic|||The proportion of participants experiencing improvement in itching versus non-improvement (including missing) was compared between the 2 treatment groups for Day 7 using the logistic regression model with baseline itching score, and EB type as covariates.||2.752|0.759|0.262
70975147|NCT00847587|141457344|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 8 additional hours was chosen to be clinically relevant, as many common medical interventions (such as epidural anesthesia, cesarean delivery, labor induction, and general stress) have been reported to delay time to lactogenesis stage II by up to 12 hours.|Mean Difference (Final Values)|0.03|STANDARD_DEVIATION|120.0|<|0.05|TWO_SIDED|95.0|-10.6|7.7|||t-test, 2 sided|||It was assumed that both groups would have a mean of 54 hours to lactogenesis with a common standard deviation of 12 hours based on previous reports of lactogenesis in women with uncomplicated vaginal deliveries. Setting the noninferiority margin at 8 additional hours, using an alpha 0.05 level comparison, to achieve 80% power a sample size of n=34 evaluable subjects was required in each group. The calculation was performed using N Solution 2007 Professional Software.||7.7|-10.6|<0.05
71033822|NCT03123471|141577235|SUPERIORITY||Difference in Response|26.2|||<|0.0001|TWO_SIDED|95.0|13.9|38.5|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||38.5|13.9|< 0.0001
71095663|NCT02384460|141699703|OTHER|Pre-specified.|Odds Ratio (OR)|0.596||||0.098|TWO_SIDED|95.0|0.323|1.1||p-value is from the logistic regression model for treatment comparison.|Regression, Logistic|||The proportion of participants experiencing improvement in pain versus non-improvement (including missing) was compared between the 2 treatment groups for Day 7 using the logistic regression model with baseline pain score and EB type as covariates.||1.1|0.323|0.098
70975148|NCT00847587|141457345|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.61|STANDARD_DEVIATION|1.8|<|0.05|TWO_SIDED|95.0|-1.3|2.5|||t-test, 2 sided|||||2.5|-1.3|<0.05
71095664|NCT01060111|141699704|SUPERIORITY_OR_OTHER|||||||0.6207|||||||ANOVA|Analysis of Variance (ANOVA) for treatment groups (Topiramate standard, Topiramate slow, Topiramate slow and Propranolol booster) was used.||||||0.6207
70975149|NCT05425563|141457353|OTHER||Slope|8.3269|STANDARD_ERROR_OF_MEAN|0.8792|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||< .001
70975150|NCT05425563|141457354|OTHER||Slope|8.0809|STANDARD_ERROR_OF_MEAN|0.5414|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||< .001
71095665|NCT01060111|141699704|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferioirity was to be concluded if the ratio of percentage decrease in migraine episodes was greater than 0.7. Power of calculation was 0.9, significance level was 0.025.|Ratio of percentage decrease|0.95||||0.5|TWO_SIDED|95.0|0.519|1.737|||t-test, 1 sided|||||1.737|0.519|0.5
71095666|NCT01060111|141699705|SUPERIORITY_OR_OTHER|||||||0.7247|||||||ANOVA|Analysis of Variance (ANOVA) for treatment groups (Topiramate standard, Topiramate slow, Topiramate slow and Propranolol booster) was used.||||||0.7247
70975151|NCT05425563|141457355|OTHER||Slope|8.121|STANDARD_ERROR_OF_MEAN|0.481|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||< .001
70975152|NCT05425563|141457362|OTHER||Slope|34.613|STANDARD_ERROR_OF_MEAN|0.602|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||< .001
70975153|NCT05425563|141457363|OTHER||Slope|33.9754|STANDARD_ERROR_OF_MEAN|0.426||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||.001
70975154|NCT05425563|141457364|OTHER||Slope|31.63|STANDARD_ERROR_OF_MEAN|0.422|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||< .001
70975155|NCT01087541|141457379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_DEVIATION|0.5|<|0.01||95.0|0.0|1.0|||t-test, 2 sided|||||1|0|<0.01
70975156|NCT01087541|141457381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|STANDARD_DEVIATION|5.0|<|0.001|TWO_SIDED|95.0|2.0|15.0|||t-test, 2 sided|||||15|2|<0.001
70975157|NCT00168831|141457382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value|Tiotropium Respimat 5mcg - Placebo|||||<0.0001
70975158|NCT00168831|141457382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry,centre and baseline value|Tiotropium Respimat 10mcg - Placebo|||||<0.0001
70975159|NCT00168831|141457383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.713|STANDARD_ERROR_OF_MEAN|1.052||0.0004||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|||||0.0004
70975160|NCT00168831|141457383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.445|STANDARD_ERROR_OF_MEAN|1.059||0.0012||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|||||0.0012
70975161|NCT00168831|141457384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.053|STANDARD_ERROR_OF_MEAN|0.165|<|0.0001||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|||||<0.0001
70975162|NCT00168831|141457384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.075|STANDARD_ERROR_OF_MEAN|0.166|<|0.0001||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|||||<0.0001
70975163|NCT00168831|141457385|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.782||||0.0002|TWO_SIDED|95.0|0.687|0.89|||Poisson regression||Tiotropium Respimat 5mcg vs. Placebo|||0.890|0.687|0.0002
70975164|NCT00168831|141457385|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.725|||<|0.0001|TWO_SIDED|95.0|0.635|0.828|||Poisson regression||Tiotropium Respimat 10mcg vs. Placebo|||0.828|0.635|<0.0001
70975165|NCT00168831|141457429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
70975166|NCT00168831|141457429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.252|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|||||ANCOVA||Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
70975167|NCT00168831|141457430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
70975168|NCT00168831|141457430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.212|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
70975169|NCT00168831|141457431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.369|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
70975170|NCT00168831|141457431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.393|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
70975171|NCT00168831|141457432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.9|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
70975172|NCT00168831|141457432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.7|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
70975173|NCT00168831|141457433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.0|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
70975174|NCT00168831|141457433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|39.1|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
70975175|NCT00168831|141457434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0169||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||0.0169
70975176|NCT00168831|141457434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
70975177|NCT04652804|141457456|SUPERIORITY||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|1.0|1.19||||||Reference group: Low Intensity Intervention||1.19|1.00|
70975178|NCT04652804|141457456|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.9|1.05||||||Reference Group: Low Intensity Intervention||1.05|0.90|
70975179|NCT04652804|141457456|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.8|1.15||||||Reference group: High Intensity Intervention||1.15|0.80|
71095667|NCT01060111|141699706|SUPERIORITY_OR_OTHER|||||||0.9872|||||||ANOVA|Analysis of Variance (ANOVA) for treatment groups (Topiramate standard, Topiramate slow, Topiramate slow and Propranolol booster) was used.||||||0.9872
70975180|NCT04652804|141457456|SUPERIORITY||Risk Ratio (RR)|0.89|||||TWO_SIDED|95.0|0.77|1.04||||||Reference group: High Intensity Intervention||1.04|0.77|
70975181|NCT01700192|141457553|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.2|-0.4|||Wilcoxon (Mann-Whitney)|||||-0.40|-1.20|<0.001
70975182|NCT01700192|141457553|SUPERIORITY_OR_OTHER||Treatment Difference Relative to Placebo|-17.2|||||TWO_SIDED|95.0|-25.0|-9.7||||||||-9.7|-25.0|
70975183|NCT01700192|141457556|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.6|||<|0.001|TWO_SIDED|95.0|-1.0|-0.3|||Wilcoxon (Mann-Whitney)|||||-0.30|-1.00|<0.001
70975184|NCT01700192|141457556|SUPERIORITY_OR_OTHER||Treatment Difference Relative to Placebo|-15.5|||||TWO_SIDED|95.0|-24.4|-7.3||||||||-7.3|-24.4|
70975185|NCT01700192|141457557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.154|TWO_SIDED|95.0|-0.35|0.05|||Zero-inflated Log-normal Model|||||0.05|-0.35|0.154
70975186|NCT01700192|141457557|SUPERIORITY_OR_OTHER||Treatment Difference Relative to Placebo|-18.4|||||TWO_SIDED|95.0|-41.0|4.3||||||||4.3|-41|
70975187|NCT01700192|141457558|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.1|||<|0.001|TWO_SIDED|95.0|-1.7|-0.6|||Wilcoxon (Mann-Whitney)|||||-0.60|-1.70|<0.001
70975188|NCT01700192|141457558|SUPERIORITY_OR_OTHER||Treatment Difference Relative to Placebo|-16.7|||||TWO_SIDED|95.0|-24.6|-4.0||||||||-4.0|-24.6|
70975189|NCT01700192|141457559|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-6.1|||<|0.001|TWO_SIDED|95.0|-9.1|-3.1|||Wilcoxon (Mann-Whitney)|||||-3.10|-9.10|<0.001
70975190|NCT01700192|141457559|SUPERIORITY_OR_OTHER||Treatment Difference Relative to Placebo|-16.0|||||TWO_SIDED|95.0|-22.7|-8.3||||||||-8.3|-22.7|
71095668|NCT01060111|141699707|SUPERIORITY_OR_OTHER|||||||0.4326||||||Analysis of Variance (ANOVA) for treatment groups (Topiramate standard, Topiramate slow, Topiramate slow and Propranolol booster) was used.|ANOVA|||||||0.4326
71095669|NCT00997126|141699716|SUPERIORITY_OR_OTHER|||||||0.657|||||||Chi-squared|||||||0.657
70975191|NCT03543410|141457571|SUPERIORITY||Mean Difference (Final Values)|-3.29|STANDARD_ERROR_OF_MEAN|1.625||0.044|TWO_SIDED|95.0|-6.489|-0.09||nominal p-value|Mixed Models Analysis|||||-0.090|-6.489|0.044
70975192|NCT03543410|141457571|SUPERIORITY||Mean Difference (Final Values)|-3.128|STANDARD_ERROR_OF_MEAN|1.597||0.051|TWO_SIDED|95.0|-6.273|0.017||nominal p-value|Mixed Models Analysis|||||0.017|-6.273|0.051
70975193|NCT03543410|141457572|SUPERIORITY||Mean Difference (Final Values)|-0.281|STANDARD_ERROR_OF_MEAN|0.191||0.143|TWO_SIDED|95.0|-0.658|0.095||nominal p-value|Mixed Models Analysis|||||0.095|-0.658|0.143
70975194|NCT03543410|141457572|SUPERIORITY||Mean Difference (Final Values)|-0.219|STANDARD_ERROR_OF_MEAN|0.187||0.243|TWO_SIDED|95.0|-0.588|0.15||nominal p-value|Mixed Models Analysis|||||0.150|-0.588|0.243
70975195|NCT00820755|141457580|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.959||||0.1265|TWO_SIDED|95.0|0.736|1.25|||Log Rank|||Exploratory analysis to test the null hypothesis of no difference between maintenance therapy regimen. Model is adjusted by histology (interactive voice response system \[IVRS\]) and tumor response status at the end of combination therapy ('complete response \[CR\] or partial response \[PR\]' versus 'other').||1.250|0.736|0.1265
70975196|NCT00820755|141457582|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.774||||0.0622||95.0|0.613|0.976|||Log Rank|||Exploratory analysis to test the null hypothesis of no difference between maintenance therapy regimen. Model is adjusted by histology (IVRS) and tumor response status at the end of combination therapy ('CR or PR' versus 'other').||0.976|0.613|0.0622
70975197|NCT00874250|141457597|SUPERIORITY_OR_OTHER||Proportion|0.98||||0.0024|TWO_SIDED|95.0|0.895|0.996|||Binomial Test|||||0.996|0.895|0.0024
70975198|NCT02105415|141457625|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.385|TWO_SIDED|95.0|-6.9|2.7|||ANCOVA|||5 minutes||2.7|-6.9|0.385
70975199|NCT02105415|141457625|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.241|TWO_SIDED|95.0|-10.8|2.8|||ANCOVA|||10 minutes||2.8|-10.8|0.241
70975200|NCT02105415|141457625|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.802|TWO_SIDED|95.0|-7.2|5.6|||ANCOVA|||15 minutes||5.6|-7.2|0.802
70975201|NCT02105415|141457626|SUPERIORITY|||||||0.605|||||||ANCOVA|||||||0.605
70975202|NCT02105415|141457627|SUPERIORITY|||||||0.212|||||||ANCOVA|||Pre-treatment||||0.212
70975203|NCT02105415|141457627|SUPERIORITY|||||||0.308|||||||ANCOVA|||New-onset pressors (within 3 minutes)||||0.308
70975204|NCT02105415|141457627|SUPERIORITY|||||||0.691|||||||ANCOVA|||Delayed-onset pressors (within 24 hrs)||||0.691
70975205|NCT02105415|141457629|SUPERIORITY|||||||0.911|||||||ANCOVA|||||||0.911
70975206|NCT02105415|141457630|SUPERIORITY|||||||0.069|||||||ANCOVA|||Red blood cell||||0.069
70975207|NCT02105415|141457630|SUPERIORITY|||||||0.046|||||||ANCOVA|||Non-red blood cell||||0.046
70975208|NCT02105415|141457630|SUPERIORITY|||||||0.502|||||||ANCOVA|||Colloid||||0.502
70975209|NCT02105415|141457631|SUPERIORITY|||||||0.994|||||||ANCOVA|||||||0.994
70975210|NCT02105415|141457632|SUPERIORITY|||||||0.233|||||||ANCOVA|||||||0.233
70975211|NCT01116544|141457693|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.005|TWO_SIDED|||||A priori threshold = 0.05|Wilcoxon (Mann-Whitney)|||||||<0.005
70975212|NCT01116544|141457694|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis called for sample sizes of 32 participants in each treatment group. The study was close before reaching this number of participants.|||||<|0.001||||||Hypothesis: significant increase in score (post-tx - pre-tx) for both groups|ANCOVA|FMA scores adjusted for baseline differences.||||||<0.001
70975213|NCT01116544|141457695|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||Across both groups, whether score increased following completion of intervention|ANCOVA|||||||0.001
70975214|NCT01116544|141457696|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||||||Across both treatment groups|ANCOVA|||||||0.001
70975215|NCT01116544|141457697|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Data combined between 2 treatment groups||||0.001
70975216|NCT01116544|141457698|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Both treatment groups combined||||>0.05
71095670|NCT02122952|141699751|SUPERIORITY||||||<|0.001|||||||One-sided Exact Binomial Test|||Data for the current study were compared to historical control data (Pediatric Neuromuscular Clinical Research \[PNCR\], Finkel et al 2014 - PubMed 25080519) where 0 participants were able to sit independently.||||<0.001
71095671|NCT00896233|141699752|SUPERIORITY_OR_OTHER||ICC|0.9|||||TWO_SIDED|90.0|0.81|0.99||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Common ROI.||0.99|0.81|
71033823|NCT03123471|141577236|SUPERIORITY||Difference in Response|17.0|||<|0.0001|TWO_SIDED|95.0|9.8|24.2|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 2; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||24.2|9.8|<0.0001
71033824|NCT03123471|141577236|SUPERIORITY||Difference in Response|22.1|||<|0.0001|TWO_SIDED|95.0|12.9|31.4|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 4. The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||31.4|12.9|<0.0001
71033825|NCT03123471|141577236|SUPERIORITY||Difference in Response|20.1||||0.0003|TWO_SIDED|95.0|9.1|31.0|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 8; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||31.0|9.1|0.0003
71033826|NCT03123471|141577236|SUPERIORITY||Difference in Response|20.6||||0.0007|TWO_SIDED|95.0|8.7|32.4|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 12; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and SE using a normal approximation to the weighted average were calculated.||32.4|8.7|0.0007
71033827|NCT03123471|141577237|SUPERIORITY||Difference in Response|14.6||||0.0025|TWO_SIDED|95.0|5.1|24.1|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 2; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||24.1|5.1|0.0025
71033828|NCT03123471|141577237|SUPERIORITY||Difference in Response|21.3|||<|0.0001|TWO_SIDED|95.0|10.6|31.9|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 4; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||31.9|10.6|<0.0001
71095672|NCT00896233|141699752|SUPERIORITY_OR_OTHER||ICC|0.85|||||TWO_SIDED|90.0|0.71|0.98||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Common ROI.||0.98|0.71|
71033829|NCT03123471|141577237|SUPERIORITY||Difference in Response|22.0||||0.0003|TWO_SIDED|95.0|10.2|33.9|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 8; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||33.9|10.2|0.0003
71033830|NCT03123471|141577237|SUPERIORITY||Difference in Response|27.0|||<|0.0001|TWO_SIDED|95.0|15.1|38.9|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 12; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and SE using a normal approximation to the weighted average were calculated.||38.9|15.1|<0.0001
71033831|NCT03123471|141577238|SUPERIORITY||Difference in LS Mean|-2.9|||<|0.0001|TWO_SIDED|95.0|-4.17|-1.73|||ANCOVA|Treatment and stratification factor (Baseline ScPGA moderate or severe) as independent variables and baseline value as a covariate variable.||||-1.73|-4.17|<0.0001
71033832|NCT01641380|141577242|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.75|||<|0.05|TWO_SIDED|95.0|-1.4|0.06|||Regression, Linear|||We also evaluated the difference between the number of days after the scheduled appointment patients returned.||.06|-1.4|<.05
71095673|NCT00896233|141699752|SUPERIORITY_OR_OTHER||ICC|0.88|||||TWO_SIDED|90.0|0.78|0.98||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Individual ROI.||0.98|0.78|
71095674|NCT00896233|141699752|SUPERIORITY_OR_OTHER||ICC|0.86|||||TWO_SIDED|90.0|0.75|0.98||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Individual ROI.||0.98|0.75|
71033833|NCT01641380|141577242|SUPERIORITY_OR_OTHER_LEGACY||Difference of proportions|0.417||||0.5187|TWO_SIDED|95.0|-13.3307|24.8818|||Chi-squared||Intervention 34/50; Control : 28/50|On time for 1st follow-up visit||24.8818|-13.3307|0.5187
71033834|NCT01641380|141577245|SUPERIORITY_OR_OTHER_LEGACY||[Proportion of Eligible Patients Enrolle|0.948|||||TWO_SIDED|||||||||||||
71033835|NCT03238781|141577251|SUPERIORITY||difference in least square mean|0.26||||0.66|TWO_SIDED|95.0|-0.88|1.4||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||1.40|-0.88|0.66
71095675|NCT00896233|141699753|SUPERIORITY_OR_OTHER||ICC|0.9|||||TWO_SIDED|90.0|0.8|0.99||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Common ROI.||0.99|0.80|
70975217|NCT00695565|141457747|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.168|TWO_SIDED|95.0|||||Mixed Models Analysis|||This analysis does not take into account the subjects' screening capsaicin response (measure of nociceptor function).||||0.168
70975218|NCT00695565|141457747|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.014|TWO_SIDED|95.0|||||Mixed Models Analysis|||"Each subject was screened for responsiveness of nociceptors in the skin to a capsaicin stimulus (rated on 0-10 pain scale; 0=no pain and 10=worst possible pain). The interaction term composed of treatment assignment and capsaicin threshold was examined at the prespecified alpha level of 0.1.~This analysis includes subjects with a capsaicin rating of ≥ 2. Thirty (30) subjects in the Placebo group and 33 subjects in the active Clonidine Topical Gel (ARC-4558) group had capsaicin scores ≥ 2."||||0.014
70975219|NCT01462266|141457770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7||||0.009|TWO_SIDED|95.0|-8.3|-1.2|||Longitudinal data analysis|Adjusting for participant's use of metformin at Visit 1/Screening Visit (i.e., on metformin, or not on metformin)||||-1.2|-8.3|0.009
70975220|NCT01106846|141457775|SUPERIORITY_OR_OTHER|||||||0.947|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.947
70975221|NCT02288273|141457783|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
70975222|NCT02419508|141457792|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||< 0.001
70975223|NCT02419508|141457793|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70975224|NCT02419508|141457794|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70975225|NCT02419508|141457795|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70975226|NCT02419508|141457796|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70975227|NCT02419508|141457797|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70975228|NCT02419508|141457798|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70975229|NCT02363478|141457909|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|This statistical analysis applies to changes of amplitude of contractions, resting LES pressure and IRP between baseline and week 4.||||||<0.05
70975230|NCT02363478|141457912|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|This statistical analysis applies to changes of amplitude of heartburn, regurgitation, chest pain and dysphagia between baseline and week 4.||||||0.05
70975231|NCT02554929|141457918|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.42||0.002|TWO_SIDED|95.0|-0.91|0.74||P value adjusted for multiple comparison; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||Values above are for the primary outcome measure of the Anxiety Disorders Interview Schedule for DSM-IV, Clinical Severity Rating (ADIS-CSR) score for SAD.|In our previous study, 42% participants in the CBT arm lost their primary diagnosis of social anxiety disorder (SAD) and/or selective mutism (SM) post-intervention versus none of the comparison group participants. In the present study, we conservatively estimated that 10% of comparison group children will lose their primary diagnosis. A sample size of 70 achieves a power of 81% to detect a 32% difference between treatments, using a two-sided Chi-squared test with a significance level of 0.05.||0.74|-0.91|0.002
70975232|NCT02554929|141457918|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.62||0.002|TWO_SIDED|95.0|-0.95|1.48||P value adjusted for multiple comparison; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||Values above are for the primary outcome measure of the Anxiety Disorders Interview Schedule for DSM-IV, Clinical Severity Rating (ADIS-CSR) score for SM.|In our previous study, 42% participants in the CBT arm lost their primary diagnosis of social anxiety disorder (SAD) and/or selective mutism (SM) post-intervention versus none of the comparison group participants. In the present study, we conservatively estimated that 10% of comparison group children will lose their primary diagnosis. A sample size of 70 achieves a power of 81% to detect a 32% difference between treatments, using a two-sided Chi-squared test with a significance level of 0.05.||1.48|-0.95|0.002
70975233|NCT02554929|141457921|SUPERIORITY||Mean Difference (Final Values)|1.89|STANDARD_ERROR_OF_MEAN|3.14||0.002|TWO_SIDED|95.0|-4.28|8.08||P value adjusted for multiple comparison; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||The estimated value of the estimation parameter corresponds to the difference between change in CGAS scores for participants in the CBT arm, in comparison to those in the socialization arm, from pre-treatment to 6-month follow-up.|In our previous study, 42% participants in the CBT arm lost their primary diagnosis of social anxiety disorder (SAD) and/or selective mutism (SM) post-intervention versus none of the comparison group participants. In the present study, we conservatively estimated that 10% of comparison group children will lose their primary diagnosis. A sample size of 70 achieves a power of 81% to detect a 32% difference between treatments, using a two-sided Chi-squared test with a significance level of 0.05.||8.08|-4.28|0.002
70975234|NCT03569202|141457949|SUPERIORITY||Mean Difference (Final Values)|1.8837||||0.662|TWO_SIDED|95.0|-6.7081|10.4756||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline||10.4756|-6.7081|0.662
70975235|NCT03569202|141457949|OTHER||Mean Difference (Final Values)|-24.6445|||<|0.0001|TWO_SIDED|95.0|-30.7199|-18.5692||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||-18.5692|-30.7199|<0.0001
70975236|NCT03569202|141457949|OTHER||Mean Difference (Final Values)|-26.5283|||<|0.0001|TWO_SIDED|95.0|-32.6036|-20.4529||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||-20.4529|-32.6036|<0.0001
70975237|NCT03569202|141457950|OTHER||Mean Difference (Final Values)|-2.9808||||0.575|TWO_SIDED|95.0|-13.6005|7.639||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline||7.6390|-13.6005|0.575
71095676|NCT00896233|141699753|SUPERIORITY_OR_OTHER||ICC|0.88|||||TWO_SIDED|90.0|0.78|0.99||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Common ROI.||0.99|0.78|
71095677|NCT00896233|141699753|SUPERIORITY_OR_OTHER||ICC|0.93|||||TWO_SIDED|90.0|0.87|1.0||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Individual ROI.||1.00|0.87|
70975238|NCT03569202|141457950|OTHER||Mean Difference (Final Values)|-4.75||||0.2098|TWO_SIDED|95.0|-12.2593|2.7593||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||2.7593|-12.2593|0.2098
70975239|NCT03569202|141457950|OTHER||Mean Difference (Final Values)|-1.7692||||0.6381|TWO_SIDED|95.0|-9.2785|5.7401||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||5.7401|-9.2785|0.6381
70975240|NCT03569202|141457951|OTHER||Mean Difference (Final Values)|0.8462||||0.271|TWO_SIDED|95.0|-0.6792|2.3715||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline||2.3715|-0.6792|0.271
70975241|NCT03569202|141457951|OTHER||Mean Difference (Final Values)|1.7115||||0.0025|TWO_SIDED|95.0|0.633|2.7901||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||2.7901|0.6330|0.0025
70975242|NCT03569202|141457951|OTHER||Mean Difference (Final Values)|0.8654||||0.1134|TWO_SIDED|95.0|-0.2132|1.944||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||1.9440|-0.2132|0.1134
70975243|NCT03569202|141457952|OTHER||Mean Difference (Final Values)|2.1731||||0.412|TWO_SIDED|95.0|-3.1016|7.4477||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline||7.4477|-3.1016|0.412
70975244|NCT03569202|141457952|OTHER||Mean Difference (Final Values)|0.01923||||0.9918|TWO_SIDED|95.0|-3.7105|3.749||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||3.7490|-3.7105|0.9918
70975245|NCT03569202|141457952|OTHER||Mean Difference (Final Values)|-2.1538||||0.2516|TWO_SIDED|95.0|-5.8836|1.5759||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||1.5759|-5.8836|0.2516
70975246|NCT03569202|141457953|OTHER||Mean Difference (Final Values)|0.5093||||0.047|TWO_SIDED|95.0|0.007267|1.0113||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline||1.0113|0.007267|0.047
70975247|NCT03569202|141457953|OTHER||Mean Difference (Final Values)|0.5596||||0.0026|TWO_SIDED|95.0|0.2046|0.9146||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||0.9146|0.2046|0.0026
70975248|NCT03569202|141457953|OTHER||Mean Difference (Final Values)|0.05032||||0.777|TWO_SIDED|95.0|-0.3047|0.4053||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||0.4053|-0.3047|0.7770
71095678|NCT00896233|141699753|SUPERIORITY_OR_OTHER||ICC|0.94|||||TWO_SIDED|90.0|0.88|1.0||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Individual ROI.||1.00|0.88|
70975249|NCT03569202|141457954|OTHER||Wilcoxon Z statistic|-0.7604||||0.447|TWO_SIDED|||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Between-group comparison, change from baseline||||0.447
70975250|NCT03569202|141457954|OTHER|||||||0.014||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.014
71095679|NCT02965456|141699771|SUPERIORITY||||||<|0.001||||||Threshold for significance at 0.05.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) with factors of treatment group and analysis center and the respective baseline lesion count as a covariate.||||<0.001
70975251|NCT03569202|141457954|OTHER|||||||0.07||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.070
70975252|NCT03569202|141457955|OTHER||Wilcoxon Z statistic|-0.6396||||0.522|TWO_SIDED|||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Between-group comparison, change from baseline||||0.522
70975253|NCT03569202|141457955|OTHER|||||||0.119||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.119
70975254|NCT03569202|141457955|OTHER|||||||0.9||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.900
70975255|NCT03569202|141457956|OTHER||Wilcoxon Z statistic|-0.5387||||0.59|TWO_SIDED|||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Between-group comparison, change from baseline||||0.590
70975256|NCT03569202|141457956|OTHER|||||||0.043||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.043
70975257|NCT03569202|141457956|OTHER|||||||0.442||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.442
70975258|NCT03569202|141457958|OTHER||Wilcoxon Z statistic|0.9208||||0.357|TWO_SIDED|||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Between-group comparison, change from baseline||||0.357
70975259|NCT03569202|141457958|OTHER|||||||0.001||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.001
70975260|NCT03569202|141457958|OTHER|||||||0.065||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.065
70975261|NCT03569202|141457959|OTHER||Wilcoxon Z statistic|1.044||||0.296|TWO_SIDED|||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Between-group comparison, change from baseline||||0.296
71095680|NCT02965456|141699772|SUPERIORITY||||||<|0.001||||||Threshold for significance at 0.05.|ANCOVA|||Analysis was performed using ANCOVA with factors of treatment group and analysis center and the respective baseline lesion count as a covariate.||||<0.001
71095681|NCT02965456|141699773|SUPERIORITY|||||||0.007||||||Threshold for significance at 0.05.|Regression, Logistic|||Analysis was performed using a logistic regression test (using Firth's Penalized Likelihood) with factors of treatment group and analysis center.||||0.007
71095682|NCT01860404|141699812|SUPERIORITY|||||||0.871|||||||Kruskal-Wallis|||||||0.871
71095683|NCT01860404|141699813|SUPERIORITY|||||||0.14|||||||Kruskal-Wallis|||||||0.140
70975262|NCT03569202|141457959|OTHER|||||||0.012||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.012
70975263|NCT03569202|141457959|OTHER||||||>|0.05||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||>0.05
70975264|NCT03569202|141457961|OTHER||Mean Difference (Final Values)|-1.9911||||0.764|TWO_SIDED|95.0|-15.6117|11.6295||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline||11.6295|-15.6117|0.764
70975265|NCT03569202|141457961|OTHER||Mean Difference (Final Values)|-17.0625||||0.0038|TWO_SIDED|95.0|-27.928|-6.197||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||-6.1970|-27.9280|0.0038
70975266|NCT03569202|141457961|OTHER||Mean Difference (Final Values)|-15.0714||||0.0011|TWO_SIDED|95.0|-23.285|-6.8579||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||-6.8579|-23.2850|0.0011
70975267|NCT00454779|141458015|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.629||||0.051|TWO_SIDED|95.0|0.395|1.002|||Regression, Cox|Stratified by IVRS randomization factors|Hazard ratio is presented as panitumumab plus chemotherapy:chemotherapy alone.|||1.002|0.395|0.051
70975268|NCT00454779|141458015|SUPERIORITY_OR_OTHER|||||||0.048|||||||Log Rank|Stratified by IVRS randomization factors||||||0.048
70975269|NCT00454779|141458016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.23|||||TWO_SIDED|95.0|-11.67|24.12|||||With Mantel-Haenszel weights within strata defined by randomization factors recorded in the IVRS|||24.12|-11.67|
70975270|NCT00454779|141458016|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||||95.0|0.57|3.33|||||Calculated from a logistic regression model with treatment indicator and randomization factors (recorded on the CRF) as covariates|||3.33|0.57|
70975271|NCT00454779|141458017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.78|||||TWO_SIDED|95.0|-8.29|23.85|||||With Mantel-Haenszel weights within strata defined by randomization factors recorded in the IVRS|||23.85|-8.29|
70975272|NCT00454779|141458017|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.76||||||95.0|0.62|5.26|||||Calculated from a logistic regression model with treatment indicator and randomization factors (recorded on the CRF) as covariates|||5.26|0.62|
70975273|NCT00454779|141458020|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.103||||0.663|TWO_SIDED|95.0|0.709|1.717|||Regression, Cox|Stratified by IVRS randomization factors|Hazard ratio is presented as panitumumab plus chemotherapy:chemotherapy alone|||1.717|0.709|0.663
70975274|NCT00454779|141458020|SUPERIORITY_OR_OTHER|||||||0.666|||||||Log Rank|Stratified by IVRS randomization factors||||||0.666
70975275|NCT02397473|141458027|SUPERIORITY||LSMean Difference|-3.47|STANDARD_ERROR_OF_MEAN|1.63||0.036|TWO_SIDED|95.0|-6.72|-0.23|||Mixed Models Analysis|||||-0.23|-6.72|0.036
70975276|NCT02397473|141458028|SUPERIORITY|||||||0.046|||||||ANCOVA|Koch's nonparametric randomization-based ANCOVA.||||||0.046
70975277|NCT02397473|141458029|SUPERIORITY||LSMean Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.2||0.493|TWO_SIDED|95.0|-3.23|1.57|||Mixed Models Analysis|||||1.57|-3.23|0.493
70975278|NCT02397473|141458030|SUPERIORITY||Odds Ratio (OR)|3.046||||0.016|TWO_SIDED|95.0|1.242|7.469|||Mixed Models Analysis|||||7.469|1.242|0.016
70975279|NCT02397473|141458031|SUPERIORITY||Odds Ratio (OR)|1.312||||0.575|TWO_SIDED|95.0|0.502|3.426|||Mixed Models Analysis|||||3.426|.502|0.575
70975280|NCT02397473|141458032|SUPERIORITY||Odds Ratio (OR)|0.965||||0.91|TWO_SIDED|95.0|0.512|1.819|||Mixed Models Analysis|Pseudo-likelihood-based repeated measures.||||1.819|.512|0.910
70975281|NCT02397473|141458033|SUPERIORITY||Odds Ratio (OR)|0.929||||0.841|TWO_SIDED|95.0|0.449|1.923|||Mixed Models Analysis|Pseudolikelihood-based repeated measures model||||1.923|0.449|0.841
70975282|NCT00927368|141458054|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating needle minus mean stimulating catheter is greater than 0.5 points).|Mean Difference (Final Values)|-0.16|||<|0.001|TWO_SIDED|95.0|-0.61|0.29||Significance criterion of 0.00694 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing stimulating needle to stimulating catheter on the mean time-weighted average pain score for a patient in the first 48 hours.||0.29|-0.61|< 0.001
70975283|NCT00927368|141458054|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating catheter minus mean stimulating needle is greater than 0.5 points).|Mean Difference (Final Values)|0.16||||0.03|TWO_SIDED|95.0|-0.29|0.61||Significance criterion of 0.01735 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing stimulating catheter to stimulating needle on the mean time-weighted average pain score for a patient in the first 48 hours.||0.61|-0.29|0.03
70975284|NCT00927368|141458054|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean catheter minus mean ultrasound alone is greater than 0.5 points).|Mean Difference (Final Values)|-0.12|||<|0.001|TWO_SIDED|95.0|-0.57|0.33||Significance criterion of 0.01041 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing stimulating catheter to ultrasound alone on the mean time-weighted average pain score for a patient in the first 48 hours.||0.33|-0.57|< 0.001
70975285|NCT00927368|141458054|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean ultrasound alone minus mean catheter is greater than 0.5 points).|Mean Difference (Final Values)|0.12||||0.02|TWO_SIDED|95.0|-0.33|0.57||Significance criterion of 0.01388 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing ultrasound alone to stimulating catheter on the mean time-weighted average pain score for a patient in the first 48 hours.||0.57|-0.33|0.02
71095684|NCT01860404|141699814|SUPERIORITY|||||||0.267|||||||Kruskal-Wallis|||||||0.267
71095685|NCT01860404|141699815|SUPERIORITY|||||||0.476|||||||Kruskal-Wallis|||||||0.476
70975286|NCT00927368|141458054|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating needle minus mean ultrasound alone is greater than 0.5 points).|Mean Difference (Final Values)|-0.28|||<|0.001|TWO_SIDED|95.0|-0.72|0.16||Significance criterion of 0.00347 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing stimulating needle to ultrasound alone on the mean time-weighted average pain score for a patient in the first 48 hours.||0.16|-0.72|< 0.001
70975287|NCT00927368|141458054|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean ultrasound alone minus mean stimulating needle is greater than 0.5 points).|Mean Difference (Final Values)|0.28||||0.11|TWO_SIDED|95.0|-0.16|0.72||Significance criterion of 0.02082 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing ultrasound alone to stimulating needle on the mean time-weighted average pain score for a patient in the first 48 hours.||0.72|-0.16|0.11
70975288|NCT00927368|141458055|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating catheter minus mean stimulating needle is greater than 0.5 points).|Mean Difference (Final Values)|5.0||||0.04|TWO_SIDED|95.0|-17.0|34.0||Significance criterion of 0.02082 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing stimulating catheter to stimulating needle on the log of cumulative opioid consumption score for a patient in the first 48 hours.||34|-17|0.04
70975289|NCT00927368|141458055|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating needle minus mean stimulating catheter is greater than 0.5 points).|Mean Difference (Final Values)|-5.0||||0.002|TWO_SIDED|95.0|-25.0|21.0||Significance criterion of 0.00347 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing stimulating needle to stimulating catheter on the log of cumulative opioid consumption score for a patient in the first 48 hours.||21|-25|0.002
70975290|NCT00927368|141458055|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating catheter minus mean ultrasound alone is greater than 0.5 points).|Mean Difference (Final Values)|3.0||||0.03|TWO_SIDED|95.0|-25.0|21.0||Significance criterion of 0.01735 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing stimulating catheter to ultrasound alone on the log of cumulative opioid consumption score for a patient in the first 48 hours.||21|-25|0.03
70975291|NCT00927368|141458055|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean ultrasound alone minus mean stimulating catheter is greater than 0.5 points).|Mean Difference (Final Values)|-3.0||||0.005|TWO_SIDED|95.0|-24.0|23.0||Significance criterion of 0.00694 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing ultrasound alone to stimulating catheter on the log of cumulative opioid consumption score for a patient in the first 48 hours.||23|-24|0.005
70975292|NCT00927368|141458055|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating needle minus mean ultrasound alone is greater than 0.5 points).|Mean Difference (Final Values)|-2.0||||0.006|TWO_SIDED|95.0|-22.0|25.0||Significance criterion of 0.01041 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing stimulating needle to ultrasound alone on the log of cumulative opioid consumption score for a patient in the first 48 hours.||25|-22|0.006
70975293|NCT00927368|141458055|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean ultrasound alone minus mean stimulating needle is greater than 0.5 points).|Mean Difference (Final Values)|2.0||||0.02|TWO_SIDED|95.0|-20.0|29.0||Significance criterion of 0.01388 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing ultrasound alone to stimulating needle on the log of cumulative opioid consumption score for a patient in the first 48 hours.||29|-20|0.02
70975294|NCT00927368|141458056|SUPERIORITY_OR_OTHER|||||||0.11|||||||ANOVA|||Stimulating needle versus stimulating catheter.||||0.11
70975295|NCT00927368|141458056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.0||||0.01|TWO_SIDED|95.0|6.0|75.0|||ANOVA|||Stimulating needle versus ultrasound guidance alone||75|6|0.01
71095686|NCT01860404|141699816|SUPERIORITY|||||||0.581|||||||Kruskal-Wallis|||||||0.581
71095687|NCT01860404|141699817|SUPERIORITY|||||||0.203|||||||Fisher Exact|||||||0.203
71095688|NCT01860404|141699818|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71095689|NCT01860404|141699819|SUPERIORITY|||||||0.482|||||||Kruskal-Wallis|||||||0.482
71095690|NCT01860404|141699820|SUPERIORITY|||||||0.393|||||||Kruskal-Wallis|||||||0.393
71095691|NCT01860404|141699821|SUPERIORITY|||||||0.629|||||||Kruskal-Wallis|||||||0.629
71095692|NCT01860404|141699822|SUPERIORITY|||||||0.624|||||||Regression, Linear|||||||0.624
71095693|NCT01860404|141699823|SUPERIORITY|||||||0.2554|||||||Regression, Linear|||||||0.2554
71095694|NCT01860404|141699824|SUPERIORITY|||||||0.7964|||||||Regression, Linear|||||||0.7964
71095695|NCT01860404|141699825|SUPERIORITY|||||||0.7749|||||||Regression, Linear|||||||0.7749
71095696|NCT01860404|141699826|SUPERIORITY|||||||0.0036|||||||Regression, Linear|||||||0.0036
70975296|NCT00927368|141458056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|67.0|||<|0.001|TWO_SIDED|95.0|31.0|102.0|||ANOVA|||Stimulating catheter versus ultrasound guidance alone||102|31|< 0.001
70975297|NCT00927368|141458057|SUPERIORITY_OR_OTHER||incremental cost, measured in dollars|14.0|||||TWO_SIDED||||||||Incremental cost (additional cost of stimulating needle compared to ultrasound alone).|We calculated incremental cost, defined as the additional cost of one strategy to the next less costly strategy.||||
70975298|NCT00927368|141458057|SUPERIORITY_OR_OTHER||incremental cost, measured in dollars|36.0|||||TWO_SIDED||||||||We estimated incremental cost, or additional cost of stimulating needle + catheter stimulation to stimulating needle alone.|We calculated incremental cost, defined as the additional cost of one strategy to the next less costly strategy.||||
70975299|NCT00927368|141458057|SUPERIORITY_OR_OTHER||incremental cost, measured in dollars|50.0|||||TWO_SIDED||||||||We calculated incremental cost, or the additional cost of stimulating needle + stimulating catheter to ultrasound alone.|We calculated incremental cost, defined as the additional cost of one strategy to the next less costly strategy.||||
70975300|NCT04428411|141458121|OTHER|||||||0.35|||||||t-test, 2 sided|||||||0.35
70975301|NCT04428411|141458122|OTHER|||||||0.07|||||||t-test, 2 sided|||||||0.07
70975302|NCT04428411|141458123|OTHER|||||||0.41|||||||t-test, 2 sided|||||||0.41
70975303|NCT04428411|141458124|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
70975304|NCT04428411|141458125|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
70975305|NCT04428411|141458126|OTHER|||||||0.09|||||||t-test, 2 sided|||||||0.09
70975306|NCT04428411|141458127|OTHER|||||||0.31|||||||t-test, 2 sided|||||||0.31
71095697|NCT01860404|141699827|SUPERIORITY|||||||0.0053|||||||Regression, Linear|||||||0.0053
71095698|NCT01860404|141699828|SUPERIORITY|||||||0.8234|||||||Regression, Linear|||||||0.8234
70975307|NCT04428411|141458128|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70975308|NCT04428411|141458129|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70975309|NCT04428411|141458130|OTHER|||||||0.0001|||||||t-test, 2 sided|||Comparison between Baseline and Month 4||||0.0001
70975310|NCT04428411|141458130|OTHER|||||||0.0001|||||||t-test, 2 sided|||Comparison between Baseline and Month 12||||0.0001
70975311|NCT04428411|141458131|OTHER|||||||0.0001|||||||t-test, 2 sided|||Comparison between Baseline and Month 4||||0.0001
70975312|NCT04428411|141458131|OTHER|||||||0.0001|||||||t-test, 2 sided|||Comparison between Baseline and Month 12||||0.0001
70975313|NCT04428411|141458132|OTHER|||||||0.0001|||||||t-test, 2 sided|||Comparison between Baseline and Month 4||||0.0001
70975314|NCT04428411|141458132|OTHER|||||||0.0001|||||||t-test, 2 sided|||Comparison between Baseline and Month 12||||0.0001
71095699|NCT02762604|141699829|SUPERIORITY||Mean Difference (Net)|-2.12|STANDARD_ERROR_OF_MEAN|8.79|||TWO_SIDED|95.0|-19.36|15.12|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in normal pace gait speed pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||15.12|-19.36|
71095700|NCT02762604|141699829|SUPERIORITY||Mean Difference (Net)|17.19|STANDARD_ERROR_OF_MEAN|8.05|||TWO_SIDED|95.0|1.4|32.97|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in gait speed during walking while talking pre and post intervention||32.97|1.40|
71095701|NCT02762604|141699830|SUPERIORITY||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|0.71|||TWO_SIDED|95.0|0.21|2.99|||||The estimate parameter reflects change in the number of correct letters generated pre to post intervention as a function intervention (Imagined Gait vs. Visual Imagery).|A linear mixed effects model was used to compare changes in correct letters generated pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||2.99|0.21|
70975315|NCT00356031|141458134|OTHER||||||<|0.05|||||||t-test, 1 sided|||||||<.05
70975316|NCT00356031|141458135|OTHER||||||<|0.05|||||||t-test, 1 sided|||||||<.05
70975317|NCT02167945|141458159|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
70975318|NCT02167945|141458159|SUPERIORITY||Cox Proportional Hazard Ratio|0.126|||<|0.001|TWO_SIDED|95.0|0.044|0.358|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.358|0.044|<0.001
70975319|NCT02167945|141458160|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
70975320|NCT02167945|141458160|SUPERIORITY||Cox Proportional Hazard Ratio|0.031||||0.007|TWO_SIDED|95.0|0.003|0.38|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.380|0.003|0.007
70975321|NCT02167945|141458161|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
70975322|NCT02167945|141458161|SUPERIORITY||Cox Proportional Hazard Ratio|0.038|||<|0.001|TWO_SIDED|95.0|0.009|0.156|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.156|0.009|<0.001
70975323|NCT02167945|141458162|SUPERIORITY|||||||0.86|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||0.860
71033836|NCT03238781|141577251|SUPERIORITY||difference in least square mean|0.27||||0.65|TWO_SIDED|95.0|-0.89|1.43||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||1.43|-0.89|0.65
71033837|NCT03238781|141577252|SUPERIORITY||Odds Ratio (OR)|0.82||||0.57|TWO_SIDED|95.0|0.41|1.62||2-sided significance level of 0.05|Cochran-Mantel-Haenszel|||The common odds ratios and p-values are obtained from a Cochran-Mantel-Haenszel test, stratified by stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine).||1.62|0.41|0.57
71033838|NCT03238781|141577252|SUPERIORITY||Odds Ratio (OR)|0.76||||0.45|TWO_SIDED|95.0|0.37|1.54||2-sided significance level of 0.05|Cochran-Mantel-Haenszel|||The common odds ratios and p-values are obtained from a Cochran-Mantel-Haenszel test, stratified by stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine).||1.54|0.37|0.45
71033839|NCT03238781|141577253|SUPERIORITY||difference in least square mean|-0.03||||0.94|TWO_SIDED|95.0|-0.87|0.81||2-sided significance level of 0.05|Mixed Models Analysis|||Adjusted analysis utilizes a generalized linear mixed model which includes treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (CM versus EM), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||0.81|-0.87|0.94
71033840|NCT03238781|141577253|SUPERIORITY||difference in least square mean|-0.09||||0.84|TWO_SIDED|95.0|-0.94|0.77||2-sided significance level of 0.05|Mixed Models Analysis|||||0.77|-0.94|0.84
71033841|NCT03238781|141577254|SUPERIORITY||difference in least square mean|-0.28||||0.81|TWO_SIDED|95.0|-2.56|2.01||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||2.01|-2.56|0.81
71033842|NCT03238781|141577254|SUPERIORITY||difference in least square mean|0.31||||0.79|TWO_SIDED|95.0|-2.01|2.63||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||2.63|-2.01|0.79
71033843|NCT03238781|141577255|SUPERIORITY||difference in least square mean|-0.86||||0.46|TWO_SIDED|95.0|-3.15|1.44||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||1.44|-3.15|0.46
71033844|NCT03238781|141577255|SUPERIORITY||difference in least square mean|0.56||||0.64|TWO_SIDED|95.0|-1.77|2.89||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||2.89|-1.77|0.64
71033845|NCT01249651|141577267|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilocoxon signed-rank test|||Wilcoxon signed-rank test was used to check whether the change in the frequency of heartburn during the 7-day period prior to the 8 week visit (Visit 3) compared to the frequency of heartburn during the 7-day period prior to baseline (Visit 1) was statistically significant or not.||||<0.001
71033846|NCT00787254|141577344|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.251|||<|0.0001|TWO_SIDED|95.0|0.14|0.4499|||Log Rank|||||0.4499|0.1400|<0.0001
71033847|NCT00787254|141577345|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0002
71033848|NCT00787254|141577346|SUPERIORITY_OR_OTHER|||||||0.0041||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0041
71033849|NCT00787254|141577347|SUPERIORITY_OR_OTHER|||||||0.0652||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0652
71033850|NCT00787254|141577348|SUPERIORITY_OR_OTHER|||||||0.9836||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.9836
70975324|NCT02167945|141458162|SUPERIORITY|||||||0.997||||||The Hazard Ratio for experiencing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to those who did not achieve SVR12 is infinite and the CI is not bounded due to zero events in one of the groups.|Cox proportional hazards model|||A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||||0.997
70975325|NCT02167945|141458163|SUPERIORITY|||||||0.608|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||0.608
70975326|NCT02167945|141458163|SUPERIORITY|||||||0.992||||||The Hazard Ratio for experiencing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to those who did not achieve SVR12 is infinite and the CI is not bounded due to zero events in one of the groups.|Cox proportional hazards model|||A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||||0.992
70975327|NCT02167945|141458164|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
70975328|NCT02167945|141458164|SUPERIORITY||Cox Proportional Hazard Ratio|0.133|||<|0.001|TWO_SIDED|95.0|0.057|0.313|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.313|0.057|<0.001
70975329|NCT02167945|141458166|SUPERIORITY||LS Mean Difference|-1.75|STANDARD_ERROR_OF_MEAN|0.79||0.026|TWO_SIDED|95.0|-3.3|-0.21|||ANCOVA||F2 - F0-F1|"F0-F1 vs F2 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||-0.21|-3.30|0.026
70975330|NCT02167945|141458166|SUPERIORITY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.74||0.472|TWO_SIDED|95.0|-1.97|0.91|||ANCOVA||F3 - F0-F1|"F0-F1 vs F3 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.91|-1.97|0.472
70975331|NCT02167945|141458166|SUPERIORITY||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.73||0.159|TWO_SIDED|95.0|-2.47|0.4|||ANCOVA||F4 - F0-F1|"F0-F1 vs F4 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.40|-2.47|0.159
71033851|NCT00787254|141577350|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0001
71033852|NCT00787254|141577351|SUPERIORITY_OR_OTHER|||||||0.0161||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0161
71033853|NCT00787254|141577352|SUPERIORITY_OR_OTHER|||||||0.0068||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0068
71033854|NCT00787254|141577353|SUPERIORITY_OR_OTHER|||||||0.2363||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2363
71033855|NCT00787254|141577355|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71033856|NCT00787254|141577356|SUPERIORITY_OR_OTHER|||||||0.4788||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4788
71033857|NCT00787254|141577357|SUPERIORITY_OR_OTHER|||||||0.6607||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6607
71033858|NCT00787254|141577358|SUPERIORITY_OR_OTHER|||||||0.8811||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8811
71033859|NCT00787254|141577359|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||||||1.0000
71033860|NCT00787254|141577361|SUPERIORITY_OR_OTHER|||||||0.206||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2060
71033861|NCT00787254|141577362|SUPERIORITY_OR_OTHER|||||||0.5099||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5099
71033862|NCT00787254|141577363|SUPERIORITY_OR_OTHER|||||||0.7794||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7794
71033863|NCT00787254|141577364|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||||||1.0000
71033864|NCT00787254|141577366|SUPERIORITY_OR_OTHER|||||||0.698||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6980
71033865|NCT00787254|141577367|SUPERIORITY_OR_OTHER|||||||0.4599||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4599
71033866|NCT00787254|141577368|SUPERIORITY_OR_OTHER|||||||0.0355||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0355
71033867|NCT00787254|141577369|SUPERIORITY_OR_OTHER|||||||0.7325||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7325
71033868|NCT00787254|141577371|SUPERIORITY_OR_OTHER|||||||0.8262||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8262
71033869|NCT00787254|141577372|SUPERIORITY_OR_OTHER|||||||0.7244||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7244
71033870|NCT00787254|141577373|SUPERIORITY_OR_OTHER|||||||0.9566||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.9566
71033871|NCT00787254|141577374|SUPERIORITY_OR_OTHER|||||||0.2008||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2008
71033872|NCT00787254|141577376|SUPERIORITY_OR_OTHER|||||||0.0703||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0703
71033873|NCT00787254|141577377|SUPERIORITY_OR_OTHER|||||||0.3046||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3046
71033874|NCT00787254|141577378|SUPERIORITY_OR_OTHER|||||||0.7121||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7121
70975332|NCT02167945|141458166|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.84||0.125|TWO_SIDED|95.0|-2.95|0.36|||ANCOVA||F2 - F0-F1|"F0-F1 vs F2 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.36|-2.95|0.125
70975333|NCT02167945|141458166|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.78||0.756|TWO_SIDED|95.0|-1.78|1.29|||ANCOVA||F3 - F0-F1|"F0-F1 vs F3 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||1.29|-1.78|0.756
71033875|NCT00787254|141577379|SUPERIORITY_OR_OTHER|||||||0.1522||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1522
71033876|NCT00787254|141577381|SUPERIORITY_OR_OTHER|||||||0.5328||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5328
71033877|NCT00787254|141577382|SUPERIORITY_OR_OTHER|||||||0.7223||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7223
71033878|NCT00787254|141577383|SUPERIORITY_OR_OTHER|||||||0.3117||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3117
71033879|NCT00787254|141577384|SUPERIORITY_OR_OTHER|||||||0.4344||95.0|||||t-test, 2 sided|||||||0.4344
71033880|NCT00787254|141577386|SUPERIORITY_OR_OTHER|||||||0.1571||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1571
71033881|NCT00787254|141577387|SUPERIORITY_OR_OTHER|||||||0.2503||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2503
70921931|NCT03725722|141334127|SUPERIORITY||Risk Difference (RD)|19.7|||<|0.05|TWO_SIDED|95.0|1.8|37.6||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference||37.6|1.8|<0.05
70921932|NCT03725722|141334127|SUPERIORITY||Risk Difference (RD)|23.5|||<|0.05|TWO_SIDED|95.0|5.8|41.2||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference||41.2|5.8|<0.05
70921933|NCT03725722|141334127|SUPERIORITY||Risk Difference (RD)|35.3|||<|0.0005|TWO_SIDED|95.0|17.5|53.2||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference||53.2|17.5|<0.0005
70975334|NCT02167945|141458166|SUPERIORITY||LS Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.78||0.315|TWO_SIDED|95.0|-2.32|0.75|||ANCOVA||F4 - F0-F1|"F0-F1 vs F4 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.75|-2.32|0.315
71033882|NCT00787254|141577388|SUPERIORITY_OR_OTHER|||||||0.4028||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4028
71033883|NCT00787254|141577389|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||||||1.0000
71033884|NCT00795821|141577418|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||<0.001
71033885|NCT00795821|141577420|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control for multiple comparisons, the analysis of this secondary outcome measure was pre-specified as a gated secondary objective. As the primary hypothesis was statistically significant, this hypothesis was tested at the 0.05 significance level.|Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||<0.001
71033886|NCT00795821|141577422|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||<0.001
71033887|NCT00795821|141577424|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||0.002
71033888|NCT00795821|141577426|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||ANCOVA|Model terms included treatment, investigator, and baseline score.||||||0.007
71033889|NCT00795821|141577428|SUPERIORITY_OR_OTHER|||||||0.056||95.0|||||ANCOVA|Model terms included treatment, investigator, and baseline score.||||||0.056
71033890|NCT00795821|141577430|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||0.002
71033891|NCT00795821|141577432|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||<0.001
71033892|NCT00795821|141577434|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||0.003
71033893|NCT00795821|141577436|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANCOVA|Model terms included treatment, investigator, and baseline score.||||||0.009
71033894|NCT00795821|141577438|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value for Severity of Overall Fatigue|Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||0.008
71033895|NCT00795821|141577438|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||P-value for Fatigue Interference with Daily Activities|Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||0.024
71033896|NCT00795821|141577440|SUPERIORITY_OR_OTHER|||||||0.261||95.0||||P-value for participants reporting use of primary doctor|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test controlling for investigator.||||||0.261
71033897|NCT00795821|141577440|SUPERIORITY_OR_OTHER|||||||0.868||95.0||||P-value for participants reporting use of specialist|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test controlling for investigator.||||||0.868
71033898|NCT00795821|141577440|SUPERIORITY_OR_OTHER|||||||0.495||95.0||||P-value for participants reporting other diagnostic tests|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test controlling for investigator.||||||0.495
70975335|NCT02167945|141458167|SUPERIORITY||LS Mean Difference|-1.28|STANDARD_ERROR_OF_MEAN|1.03||0.216|TWO_SIDED|95.0|-3.3|0.75|||ANCOVA||F2 - F0-F1|"F0-F1 vs F2 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.75|-3.30|0.216
70975336|NCT02167945|141458167|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.95||0.074|TWO_SIDED|95.0|-3.58|0.17|||ANCOVA||F3 - F0-F1|"F0-F1 vs F3 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.17|-3.58|0.074
70975337|NCT02167945|141458167|SUPERIORITY||LS Mean Difference|-1.81|STANDARD_ERROR_OF_MEAN|0.95||0.056|TWO_SIDED|95.0|-3.67|0.05|||ANCOVA||F4 - F0-F1|"F0-F1 vs F4 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.05|-3.67|0.056
70975338|NCT02167945|141458167|SUPERIORITY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|1.02||0.411|TWO_SIDED|95.0|-2.84|1.16|||ANCOVA||F2 - F0-F1|"F0-F1 vs F2 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||1.16|-2.84|0.411
71033899|NCT00795821|141577440|SUPERIORITY_OR_OTHER|||||||0.189||95.0||||P-value for participants reporting prescribed medication|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test controlling for investigator.||||||0.189
71033900|NCT00795821|141577442|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||P-value for suicidal ideation|Fisher Exact|||||||0.737
71033901|NCT00795821|141577444|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for change in supine systolic blood pressure|Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||0.002
71033902|NCT00795821|141577444|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change in supine diastolic blood pressure|Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||<0.001
71033903|NCT00795821|141577446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||<0.001
71033904|NCT01285713|141577449|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|95.0|||||Paired t-test|||||||0.0003
71033905|NCT02925884|141577473|SUPERIORITY|||||||0.011|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunnar OTC Condition and the Control Condition on the factor score of Decreased Cognitive Functions.||||0.011
71033906|NCT02925884|141577473|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunnar OTC Condition and the Control Condition on the factor score of Eyestrain.||||<0.001
71033907|NCT02925884|141577473|SUPERIORITY|||||||0.009|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunnar OTC Condition and the Control Condition on the factor score of Physical Discomfort.||||0.009
71033908|NCT02925884|141577473|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunnar OTC Condition and the Control Condition on the factor score of Deceased Visual Function.||||<0.001
71033909|NCT02925884|141577473|SUPERIORITY|||||||0.28|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunnar OTC Condition and the Control Condition on the factor score of Poor Balance.||||0.28
71033910|NCT02925884|141577474|SUPERIORITY|||||||0.903|||||||Mixed Models Analysis|||||||0.903
71033911|NCT02925884|141577475|SUPERIORITY|||||||0.009|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunna OTC Glasses condition and the Control condition on Red Color Perception.||||0.009
70975339|NCT02167945|141458167|SUPERIORITY||LS Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|0.93||0.065|TWO_SIDED|95.0|-3.55|0.11|||ANCOVA||F3 - F0-F1|"F0-F1 vs F3 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.11|-3.55|0.065
70975340|NCT02167945|141458167|SUPERIORITY||LS Mean Difference|-2.08|STANDARD_ERROR_OF_MEAN|0.93||0.026|TWO_SIDED|95.0|-3.91|-0.25|||ANCOVA||F4 - F0-F1|F0-F1 vs F4 at Post-treatment Week 24||-0.25|-3.91|0.026
71033912|NCT02925884|141577475|SUPERIORITY|||||||0.446|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunna OTC Glasses condition and the Control condition on Green Color Perception.||||0.446
71033913|NCT02925884|141577475|SUPERIORITY|||||||0.953|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunna OTC Glasses condition and the Control condition on Blue Color Perception.||||0.953
71033914|NCT02925884|141577476|SUPERIORITY|||||||0.266|||||||Mixed Models Analysis|||||||0.266
71033915|NCT02925884|141577477|SUPERIORITY|||||||0.424|||||||Mixed Models Analysis|||||||0.424
71033916|NCT02925884|141577478|SUPERIORITY|||||||0.343|||||||Mixed Models Analysis|||||||0.343
71033917|NCT02925884|141577479|SUPERIORITY|||||||0.489|||||||Mixed Models Analysis|||||||0.489
71033918|NCT02925884|141577480|SUPERIORITY|||||||0.885|||||||Mixed Models Analysis|||||||0.885
71033919|NCT02925884|141577481|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
70975341|NCT02167945|141458168|SUPERIORITY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.95||0.035|TWO_SIDED|95.0|-3.86|-0.14|||ANCOVA||F2 - F0-F1|"F0-F1 vs F2 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes (PRO) score and SVR12 status as covariates."||-0.14|-3.86|0.035
70975342|NCT02167945|141458168|SUPERIORITY||LS Mean Difference|-2.15|STANDARD_ERROR_OF_MEAN|0.88||0.015|TWO_SIDED|95.0|-3.88|-0.42|||ANCOVA||F3 - F0-F1|"F0-F1 vs F3 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||-0.42|-3.88|0.015
70975343|NCT02167945|141458168|SUPERIORITY||LS Mean Difference|-1.74|STANDARD_ERROR_OF_MEAN|0.88||0.048|TWO_SIDED|95.0|-3.46|-0.01|||ANCOVA||F4 - F0-F1|F0-F1 vs F4 at Post-treatment Week 12||-0.01|-3.46|0.048
70975344|NCT02167945|141458168|SUPERIORITY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.99||0.466|TWO_SIDED|95.0|-2.67|1.22|||ANCOVA||F2 - F0-F1|"F0-F1 vs F2 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||1.22|-2.67|0.466
70975345|NCT02167945|141458168|SUPERIORITY||LS Mean Difference|-1.91|STANDARD_ERROR_OF_MEAN|0.91||0.035|TWO_SIDED|95.0|-3.7|-0.13|||ANCOVA||F3 - F0-F1|"F0-F1 vs F3 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||-0.13|-3.70|0.035
70975346|NCT02167945|141458168|SUPERIORITY||LS Mean Difference|-2.22|STANDARD_ERROR_OF_MEAN|0.91||0.015|TWO_SIDED|95.0|-4.01|-0.43|||ANCOVA||F4 - F0-F1|"F0-F1 vs F4 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||-0.43|-4.01|0.015
70975347|NCT01046695|141458206|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||Decrease in OME use in the TENS Unit during the first and second 24 hours.||||.005
70975348|NCT01046695|141458206|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||t-test, 2 sided|||Decrease in OME use in the Control Arm during the first and second 24 hours.||||.11
70975349|NCT01046695|141458207|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||t-test, 2 sided|||||||.70
70975350|NCT00408694|141458219|OTHER|||||||||||||||||Null hypothesis, H0: Incidence of patients with either grade 4 hemorrhage or any grade 5 adverse event for the protocol treatment regimen ≤ 0.05. Alternative hypothesis, HA: Incidence of patients with either grade 4 hemorrhage or any grade 5 adverse event for the protocol treatment regimen ≥ 0.15.|If 3 of the first 14 patients or 4 of the first 42 patients experience the specified adverse events, then the regimen is considered unacceptable as calculated by the Fleming method for a two-stage design with type I error and the statistical power were set at 0.14 and 0.83, respectively.|||
70975351|NCT02063035|141458251|SUPERIORITY|||||||0.1318|||||||Wilcoxon (Mann-Whitney)|||||||0.1318
70975352|NCT00091832|141458272|SUPERIORITY_OR_OTHER|||||||0.245|||||||ANCOVA|Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)||||||0.245
70975353|NCT00091832|141458273|SUPERIORITY_OR_OTHER|||||||0.848|||||||ANCOVA|Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)||||||0.848
70975354|NCT00091832|141458274|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72||||||95.0|0.68|4.35|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||4.35|0.68|
70975355|NCT00091832|141458274|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||||95.0|0.51|3.24|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||3.24|0.51|
70975356|NCT00091832|141458274|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||||95.0|0.34|2.29|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||2.29|0.34|
70975357|NCT00091832|141458274|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||||95.0|0.51|3.2|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||3.20|0.51|
70975358|NCT00091832|141458274|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74||||||95.0|0.7|4.34|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||4.34|0.70|
70975359|NCT00091832|141458275|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.82||||||95.0|0.69|4.79|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||4.79|0.69|
70975360|NCT00091832|141458275|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||||95.0|0.25|1.76|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||1.76|0.25|
71033920|NCT02925884|141577482|SUPERIORITY|||||||0.359|||||||Mixed Models Analysis|||||||0.359
71033921|NCT02301975|141577483|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was defined if the lower bound of the 95% CI for the difference between mean change from Baseline in clinic visit PM FEV1 for FF/VI and FP/S was more than -100 milliliter (mL)|Least square mean change difference|0.019|||||TWO_SIDED|95.0|-0.011|0.049||||||||0.049|-0.011|
71033922|NCT02301975|141577483|OTHER||Least square mean change difference|0.123|||<|0.001|TWO_SIDED|95.0|0.093|0.153|||Mixed Models Analysis|||||0.153|0.093|<0.001
71033923|NCT02301975|141577483|OTHER||Least square mean change difference|0.104|||<|0.001|TWO_SIDED|95.0|0.074|0.134|||Mixed Models Analysis|||||0.134|0.074|<0.001
71033924|NCT02301975|141577484|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was defined if the lower bound of the 95% CI for the difference between mean change from Baseline in clinic visit for FF/VI and FP/S was more than -100 mL|Least square mean change difference|0.006|||||TWO_SIDED|95.0|-0.027|0.04||||||||0.040|-0.027|
71033925|NCT02301975|141577484|OTHER||Least square mean change difference|0.12|||<|0.001|TWO_SIDED|95.0|0.086|0.153|||Mixed Models Analysis|||||0.153|0.086|<0.001
71033926|NCT02301975|141577484|OTHER||Least square mean change difference|0.113|||<|0.001|TWO_SIDED|95.0|0.08|0.147|||Mixed Models Analysis|||||0.147|0.080|<0.001
71033927|NCT02301975|141577485|OTHER||Least square mean change difference|1.2|||||TWO_SIDED|95.0|-0.5|3.0||||||||3.0|-0.5|
71095702|NCT02762604|141699831|SUPERIORITY||Mean Difference (Net)|2.4|STANDARD_ERROR_OF_MEAN|7.37|||TWO_SIDED|95.0|-12.04|16.85|||||The estimate parameter reflects change in functional activation/deactivation pattern from pre to post intervention as a function intervention (Imagined Gait vs. Visual Imagery).|Linear mixed effects model were used to compare changes in the functional activation/deactivation pattern (factor score) during imagery of walking-while talking (relative to walking and talking alone) pre and post intervention - as a function of of intervention (Imagined Gait vs. Visual Imagery)||16.85|-12.04|
71095703|NCT02762604|141699832|SUPERIORITY||Mean Difference (Net)|-0.54|STANDARD_ERROR_OF_MEAN|6.94|||TWO_SIDED|95.0|-14.15|13.07|||||The estimate parameter is the difference in change pre to post intervention between Imagined Gait and Visual Imagery group.|Linear mixed effects model were used to compare changes in trails a time pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||13.07|-14.15|
70975361|NCT00091832|141458275|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||||95.0|0.24|1.77|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||1.77|0.24|
71033928|NCT02301975|141577485|OTHER||Least square mean change difference|2.7||||0.002|TWO_SIDED|95.0|0.9|4.4|||ANCOVA|||||4.4|0.9|0.002
71033929|NCT02301975|141577485|OTHER||Least square mean change difference|1.4||||0.106|TWO_SIDED|95.0|-0.3|3.2|||ANCOVA|||||3.2|-0.3|0.106
71033930|NCT02301975|141577486|OTHER||Least square mean change difference|1.2|||||TWO_SIDED|95.0|-0.7|3.1||||||||3.1|-0.7|
71033931|NCT02301975|141577486|OTHER||Least square mean change difference|2.7||||0.004|TWO_SIDED|95.0|0.8|4.5|||ANCOVA|||||4.5|0.8|0.004
71033932|NCT02301975|141577486|OTHER||Least square mean change difference|1.5||||0.115|TWO_SIDED|95.0|-0.4|3.3|||ANCOVA|||||3.3|-0.4|0.115
70975362|NCT00091832|141458275|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58||||||95.0|0.22|1.58|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||1.58|0.22|
71033933|NCT02301975|141577487|OTHER||Least square mean change difference|5.2|||||TWO_SIDED|95.0|1.1|9.4||||||||9.4|1.1|
71033934|NCT02301975|141577487|OTHER||Least square mean change difference|21.5|||<|0.001|TWO_SIDED|95.0|17.4|25.6|||ANCOVA|||||25.6|17.4|<0.001
71033935|NCT02301975|141577487|OTHER||Least square mean change difference|16.3|||<|0.001|TWO_SIDED|95.0|12.2|20.4|||ANCOVA|||||20.4|12.2|<0.001
70975363|NCT00091832|141458275|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||||95.0|0.25|1.92|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||1.92|0.25|
70975364|NCT00091832|141458276|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||||95.0|0.51|1.31|||||A hazard ratio \>1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.|||1.31|0.51|
71033936|NCT02301975|141577488|OTHER||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.53|1.54||||||||1.54|0.53|
71033937|NCT02301975|141577488|OTHER||Odds Ratio (OR)|1.15||||0.595|TWO_SIDED|95.0|0.69|1.9|||Regression, Logistic|||||1.90|0.69|0.595
71033938|NCT02301975|141577488|OTHER||Odds Ratio (OR)|1.27||||0.372|TWO_SIDED|95.0|0.75|2.12|||Regression, Logistic|||||2.12|0.75|0.372
71033939|NCT02301975|141577489|OTHER||Least square mean change difference|5.0|||||TWO_SIDED|95.0|0.7|9.3||||||||9.3|0.7|
71033940|NCT02301975|141577489|OTHER||Least square mean change difference|19.2|||<|0.001|TWO_SIDED|95.0|14.9|23.5|||ANCOVA|||||23.5|14.9|<0.001
71033941|NCT02301975|141577489|OTHER||Least square mean change difference|14.2|||<|0.001|TWO_SIDED|95.0|9.9|18.5|||ANCOVA|||||18.5|9.9|<0.001
71033942|NCT02826694|141577493|OTHER|||||||0.168|||||||linear mixed effect model|||T3||||0.168
71033943|NCT02826694|141577493|OTHER|||||||0.026|||||||linear mixed effect model|||T4||||0.026
71033944|NCT01609257|141577494|SUPERIORITY_OR_OTHER|||||||0.674||||||No multiplicity adjustment.|Fisher Exact|||||||0.674
71033945|NCT01609257|141577501|SUPERIORITY_OR_OTHER|||||||0.001||||||Statistically significant at p\<0.05. No multiplicity adjustment.|Wilcoxon (Mann-Whitney)|||||||0.001
71033946|NCT01609257|141577502|SUPERIORITY_OR_OTHER|||||||0.008||||||Statistically significant at p\<0.05. No multiplicity adjustment.|Wilcoxon (Mann-Whitney)|||Score 1||||0.008
71033947|NCT01609257|141577502|SUPERIORITY_OR_OTHER|||||||0.037||||||Statistically significant at p\<0.05. No multiplicity adjustment.|Wilcoxon (Mann-Whitney)|||Score 2||||0.037
71033948|NCT01609257|141577503|SUPERIORITY_OR_OTHER|||||||0.199|||||||Wilcoxon (Mann-Whitney)|||||||0.199
71033949|NCT01609257|141577504|SUPERIORITY_OR_OTHER|||||||0.562||||||Comparison of % Positive|Fisher Exact|||Any Day 1 to 30||||0.562
71033950|NCT02125461|141577527|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.0001|TWO_SIDED|95.0|0.42|0.65|||Log Rank|||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.||0.65|0.42|<0.0001
71033951|NCT02125461|141577528|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.00251|TWO_SIDED|95.0|0.53|0.87|||Log Rank|||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.||0.87|0.53|0.00251
71033952|NCT02125461|141577529|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||Analysis performed using Fisher's exact test with mid p-value modification by subtracting half of the probability of the observed table from Fisher's p-value.||||<0.001
71033953|NCT02125461|141577533|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.41|0.68|||Log Rank|||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.||0.68|0.41|<0.0001
70921934|NCT03725722|141334127|SUPERIORITY||Risk Difference (RD)|45.4|||<|0.0001|TWO_SIDED|95.0|28.1|62.8||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference||62.8|28.1|<0.0001
70975365|NCT00091832|141458276|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||||95.0|0.64|1.65|||||A hazard ratio \>1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.|||1.65|0.64|
70975366|NCT00091832|141458276|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||||95.0|0.68|1.74|||||A hazard ratio \>1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.|||1.74|0.68|
70975367|NCT00091832|141458276|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||||95.0|0.68|1.74|||||A hazard ratio \>1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.|||1.74|0.68|
70975368|NCT00091832|141458276|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||||95.0|0.71|1.83|||||A hazard ratio \>1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.|||1.83|0.71|
70975369|NCT00091832|141458287|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.543||||||95.0|0.159|1.856|||||A hazard ratio \<1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.|||1.856|0.159|
70975370|NCT00091832|141458287|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.544||||||95.0|0.159|1.859|||||A hazard ratio \<1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.|||1.859|0.159|
70975371|NCT00091832|141458287|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.791||||||95.0|0.266|2.355|||||A hazard ratio \<1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.|||2.355|0.266|
70975372|NCT00091832|141458287|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.073||||||95.0|0.389|2.963|||||A hazard ratio \<1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.|||2.963|0.389|
70975373|NCT00091832|141458287|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.54||||||95.0|0.158|1.847|||||A hazard ratio \<1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.|||1.847|0.158|
70975374|NCT00091832|141458288|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92||||||95.0|0.51|7.17|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||7.17|0.51|
70975375|NCT00091832|141458288|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||||95.0|0.36|3.97|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||3.97|0.36|
70975376|NCT00091832|141458288|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||||95.0|0.26|2.52|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||2.52|0.26|
70975377|NCT00091832|141458288|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88||||||95.0|0.5|7.05|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||7.05|0.5|
70975378|NCT00091832|141458288|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88||||||95.0|0.5|7.05|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||7.05|0.5|
70975379|NCT01332071|141458371|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency - ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|96.58|||||TWO_SIDED|90.0|93.44|99.83|||||The ratio between the geometric means of the test (T) and reference (R) formulations was calculated.|||99.83|93.44|
70975380|NCT01332071|141458372|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency - ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|97.76|||||TWO_SIDED|90.0|93.25|102.5|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||102.50|93.25|
70975381|NCT01332071|141458373|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency - ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|96.47|||||TWO_SIDED|90.0|93.32|99.72|||||The ratio between the geometric means of the test (T) and reference (R) formulations was calculated.|||99.72|93.32|
70975382|NCT01332071|141458374|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency - ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|95.79|||||TWO_SIDED|90.0|91.67|100.1|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||100.10|91.67|
70975383|NCT01332071|141458375|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency - ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|94.86|||||TWO_SIDED|90.0|90.7|99.22|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||99.22|90.70|
70975384|NCT01332071|141458376|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency - ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|97.88|||||TWO_SIDED|90.0|93.15|102.86|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||102.86|93.15|
71008742|NCT02055976|141525249|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-22.003|STANDARD_ERROR_OF_MEAN|14.53||0.067|TWO_SIDED|95.0|-50.882|6.875|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||6.875|-50.882|0.067
70975385|NCT01738971|141458377|SUPERIORITY_OR_OTHER||relative probability|3.13|||<|0.001||95.0|1.9|5.13|||t-test, 2 sided|see above description of analysis taking into account cluster randomisation||"Cluster randomised study design - statisitical analysis takes this into account. Analaysis was conducted at a cluster level and the proportions in each cluster using effective contraception were compared between groups by 2-sample t tests, weighted by the different number of patients in each cluster.~Comparison of number of women using effective contraception at 6-8 weeks in progestogen only pill group compared to control."||5.13|1.90|<0.001
70975386|NCT01738971|141458377|SUPERIORITY_OR_OTHER||relative probability|2.57||||0.006||95.0|1.55|4.27||see above comments regarding analysis taking cluster randomised account into consideration|t-test, 2 sided|||"Cluster randomised study design - statisitical analysis takes this into account. Analaysis was conducted at a cluster level and the proportions in each cluster using effective contraception were compared between groups by 2-sample t tests, weighted by the different number of patients in each cluster.~Comparison of number of women using effective contraception at 6-8 weeks in rapid access group compared to control."||4.27|1.55|0.006
70975387|NCT00692211|141458389|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.01|TWO_SIDED|95.0|1.04|2.32||Not adjusted for multiple comparisons, a priori threshold of 0.05|Regression, Logistic|||Study powered to detect 10% difference in proportion of screening adherence based on alpha of 0.05, beta 0.20.||2.32|1.04|0.01
70975388|NCT02531646|141458393|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence interval (-0.25, 0.25)||||||0||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician.They were rounded to fit four digits."|Equivalence test|||||||0.000
70975389|NCT02531646|141458394|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence interval (-0.25, 0.25)||||||0||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician.They were rounded to fit four digits."|Equivalence test|||||||0.000
70975390|NCT02531646|141458395|SUPERIORITY_OR_OTHER|||||||0||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician.They were rounded to fit four digits."|t-test, 1 sided|||||||0.000
70975391|NCT02531646|141458396|SUPERIORITY_OR_OTHER|||||||0||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician. They were rounded to fit four digits."|t-test, 1 sided|||||||0.000
70975392|NCT02531646|141458397|SUPERIORITY_OR_OTHER|||||||0.007||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician. They were rounded to fit four digits."|t-test, 1 sided|||||||0.007
70975393|NCT02531646|141458399|SUPERIORITY_OR_OTHER|||||||0||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician. They were rounded to fit four digits."|t-test, 1 sided|||||||0.000
70975394|NCT05888103|141458408|SUPERIORITY||LS Mean Difference|-47.5|||<|0.0001|TWO_SIDED|95.0|-52.35|-42.65|||ANCOVA|||||-42.65|-52.35|<0.0001
70975395|NCT05888103|141458409|SUPERIORITY||LS Mean Difference|-69.73|||<|0.0001|TWO_SIDED|95.0|-76.6|-62.86|||ANCOVA|||||-62.86|-76.60|<0.0001
70975396|NCT05888103|141458410|SUPERIORITY||LS Mean Difference|-77.83|||<|0.0001|TWO_SIDED|95.0|-85.86|-69.8|||ANCOVA|||||-69.80|-85.86|<0.0001
70975397|NCT05888103|141458411|SUPERIORITY||LS Mean Difference|-226.61|||<|0.0001|TWO_SIDED|95.0|-244.77|-208.45|||ANCOVA|||||-208.45|-244.77|<0.0001
70975398|NCT05888103|141458412|SUPERIORITY||LS Mean Difference|-31.49|||<|0.0001|TWO_SIDED|95.0|-34.91|-28.07|||ANCOVA|||||-28.07|-34.91|<0.0001
70975399|NCT05888103|141458413|SUPERIORITY||LS Mean Difference|-71.46|||<|0.0001|TWO_SIDED|95.0|-79.24|-63.69|||ANCOVA|||||-63.69|-79.24|<0.0001
70975400|NCT05888103|141458414|SUPERIORITY||LS Mean Difference|2.94||||0.3743|TWO_SIDED|95.0|-3.55|9.42|||ANCOVA|||||9.42|-3.55|0.3743
70975401|NCT05888103|141458415|SUPERIORITY||LS Mean Difference|1.07||||0.4228|TWO_SIDED|95.0|-1.54|3.68|||ANCOVA|||||3.68|-1.54|0.4228
70975402|NCT05888103|141458416|SUPERIORITY||LS Mean Difference|-40.57|||<|0.0001|TWO_SIDED|95.0|-44.57|-36.57|||ANCOVA|||||-36.57|-44.57|<0.0001
70975403|NCT05888103|141458417|SUPERIORITY||LS Mean Difference|-72.34|||<|0.0001|TWO_SIDED|95.0|-79.56|-65.13|||ANCOVA|||||-65.13|-79.56|<0.0001
70975404|NCT05888103|141458418|SUPERIORITY||LS Mean Difference|-36.84|||<|0.0001|TWO_SIDED|95.0|-40.72|-32.96|||ANCOVA|||||-32.96|-40.72|<0.0001
71095704|NCT02762604|141699833|SUPERIORITY||Mean Difference (Net)|-12.21|STANDARD_ERROR_OF_MEAN|20.26|||TWO_SIDED|95.0|-51.92|27.51|||||The estimate parameter is the difference in change pre to post intervention between Imagined Gait and Visual Imagery group.|Linear mixed effects model were used to compare changes in trails b time pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||27.51|-51.92|
70975405|NCT05888103|141458419|SUPERIORITY||LS Mean Difference|-41.87|||<|0.0001|TWO_SIDED|95.0|-46.28|-37.47|||ANCOVA|||||-37.47|-46.28|<0.0001
70975406|NCT05888103|141458420|SUPERIORITY||LS Mean Difference|2.05||||0.3011|TWO_SIDED|95.0|-1.84|5.93|||ANCOVA|||||5.93|-1.84|0.3011
70975407|NCT05888103|141458421|SUPERIORITY||LS Mean Difference|3.13||||0.2403|TWO_SIDED|95.0|-2.09|8.35|||ANCOVA|||||8.35|-2.09|0.2403
70975408|NCT05888103|141458422|SUPERIORITY||LS Mean Difference|-30.27|||<|0.0001|TWO_SIDED|95.0|-40.58|-19.95|||ANCOVA|||||-19.95|-40.58|<0.0001
70975409|NCT05888103|141458423|SUPERIORITY||LS Mean Difference|0.68|||<|0.0001|TWO_SIDED|95.0|0.6|0.76|||ANCOVA|||||0.76|0.60|<0.0001
70975410|NCT05888103|141458424|SUPERIORITY||LS Mean Difference|3.01||||0.5877|TWO_SIDED|95.0|-7.88|13.91|||ANCOVA|||||13.91|-7.88|0.5877
70975411|NCT05888103|141458425|SUPERIORITY||LS Mean Difference|-7.96||||0.5019|TWO_SIDED|95.0|-31.17|15.26|||ANCOVA|||||15.26|-31.17|0.5019
70975412|NCT03968419|141458441|OTHER||Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-25.56|21.23||||||Difference in MPR rate||21.23|-25.56|
70975413|NCT01815229|141458454|OTHER||||||<|0.05||||||P value applies to cell count at removal|t-test, 2 sided|||Tracheal lavages (TL) were done in intubated humans to obtain cell counts.||||<0.05
70975414|NCT00167245|141458470|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
70975415|NCT00167245|141458471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45|||||||Generalized Estimating Equations|||||||0.45
70975416|NCT00167245|141458472|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.4|TWO_SIDED|95.0|-2.1|5.2|||t-test, 2 sided|||||5.2|-2.1|0.4
70975417|NCT00804687|141458483|SUPERIORITY_OR_OTHER||Least Squares Mean difference|-0.126|STANDARD_ERROR_OF_MEAN|0.066||0.0602||95.0|-0.258|0.006|||Linear mixed model|||||0.006|-0.258|0.0602
70975418|NCT00804687|141458483|SUPERIORITY_OR_OTHER||Least Squares Mean difference|-0.195|STANDARD_ERROR_OF_MEAN|0.067||0.0043||95.0|-0.328|-0.063|||Linear mixed model|||||-0.063|-0.328|0.0043
70975419|NCT00804687|141458483|SUPERIORITY_OR_OTHER||Least Squares Mean difference|-0.066|STANDARD_ERROR_OF_MEAN|0.07||0.3513|TWO_SIDED|95.0|-0.206|0.075|||Linear mixed model|||||0.075|-0.206|0.3513
70975420|NCT00804687|141458484|SUPERIORITY_OR_OTHER||Least Squares Mean difference|8.604|STANDARD_ERROR_OF_MEAN|2.267||0.0003||95.0|4.104|13.104|||Linear mixed model|||||13.104|4.104|0.0003
70975421|NCT00804687|141458484|SUPERIORITY_OR_OTHER||Least Squares Mean difference|4.699|STANDARD_ERROR_OF_MEAN|2.289||0.0428||95.0|0.155|9.243|||Linear mixed model|||||9.243|0.155|0.0428
70975422|NCT00804687|141458484|SUPERIORITY_OR_OTHER||Least Squares Mean difference|-3.905|STANDARD_ERROR_OF_MEAN|2.277||0.0895|TWO_SIDED|95.0|-8.424|0.614|||Linear mixed model|||||0.614|-8.424|0.0895
70975423|NCT00445302|141458502|SUPERIORITY_OR_OTHER||Ratio of least squares means (%)|87.09|||||TWO_SIDED|90.0|63.59|119.26||||||||119.26|63.59|
70975424|NCT00445302|141458502|SUPERIORITY_OR_OTHER||Ratio of least squares means(%)|106.6||||||90.0|78.99|143.87||||||||143.87|78.99|
70975425|NCT00445302|141458502|SUPERIORITY_OR_OTHER||Ratio of least squares means (%)|106.76||||||90.0|79.11|144.08||||||||144.08|79.11|
70975426|NCT00445302|141458505|SUPERIORITY_OR_OTHER||Ratio of least squares means (%)|121.74||||||90.0|91.86|161.43||||||||161.43|91.86|
70975427|NCT00445302|141458505|SUPERIORITY_OR_OTHER||Ratio of least squares means (%)|151.44||||||90.0|115.78|198.09||||||||198.09|115.78|
70975428|NCT00445302|141458505|SUPERIORITY_OR_OTHER||Ratio of least squares means (%)|169.51||||||90.0|129.59|221.72||||||||221.72|129.59|
70975429|NCT03216382|141458562|SUPERIORITY|||||||0.93||||||The apriori threshold for significance was a = 0.05. The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.93
70975430|NCT03216382|141458563|SUPERIORITY|||||||0.74||||||this value represents the interaction between condition and the intervention time period The apriori threshold for significance was a = 0.05.|Mixed Models Analysis|||HLM piecewise analysis was used to examine linear change from day 1-7 (visit 1 to visit 2) and change from day 7-14 (visit 2 to visit 3) on uncontrollability of worry||||.74
70975431|NCT03216382|141458563|SUPERIORITY|||||||0.44||||||this value represents the interaction between condition and the intervention time period (squared) The apriori threshold for significance was a = 0.05.|Mixed Models Analysis|||HLM piecewise analysis was used to examine quadratic change from day 1-7 (visit 1 to visit 2) and change from day 7-14 (visit 2 to visit 3) on uncontrollability of worry||||.44
70975432|NCT03216382|141458564|SUPERIORITY|||||||0.17||||||the apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.17
70975433|NCT03216382|141458565|SUPERIORITY|||||||0.5||||||The apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time .|Mixed Models Analysis|||HLM piecewise analysis was used to examine linear change from day 1-7 (visit 1 to visit 2) and change from day 7-14 (visit 2 to visit 3) on self-focused attention||||.50
70975434|NCT03216382|141458565|SUPERIORITY|||||||0.02||||||The apriori threshold for significance was a= 0.05. The p value reflects the test of an interaction between condition and intervention period (days 7-14, squared).|Mixed Models Analysis|||HLM piecewise analysis was used to examine quadratic change from day 1-7 (visit 1 to visit 2) and change from day 7-14 (visit 2 to visit 3) on self-focused attention||||.02
70975435|NCT03216382|141458566|SUPERIORITY|||||||0.46||||||the apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.46
70975436|NCT03216382|141458567|SUPERIORITY|||||||0.53||||||the apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.53
70975437|NCT03216382|141458568|SUPERIORITY|||||||0.07||||||the apriori threshold for significance was a = 0.05. The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.07
70975438|NCT03216382|141458569|SUPERIORITY|||||||0.58||||||the apriori threshold for significance was 0.05 The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.58
70975439|NCT03216382|141458570|SUPERIORITY|||||||0.86||||||the apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.86
70975440|NCT03216382|141458571|SUPERIORITY|||||||0.39||||||the apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.39
70975441|NCT01175005|141458573|SUPERIORITY_OR_OTHER|||||||0.001|ONE_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.001
70975442|NCT01337973|141458574|SUPERIORITY||Coefficient estimate|0.82|||<|0.001|TWO_SIDED|95.0|0.37|1.84||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z value: -4.65|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall physical aggression % change from baseline||1.84|0.37|<0.001
70975443|NCT01337973|141458574|SUPERIORITY||Coefficient Estimate|0.62|||<|0.01|TWO_SIDED|95.0|0.3|1.29||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -2.83|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall injury perpetration % change from baseline||1.29|0.30|<0.01
70975444|NCT01337973|141458574|SUPERIORITY||Coefficient Estimate|1.16|||<|0.01|TWO_SIDED|95.0|0.36|3.77||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.31|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner physical aggression % change from baseline||3.77|0.36|<0.01
70975445|NCT01337973|141458574|SUPERIORITY||Coefficient Estimate|0.51|||<|0.05|TWO_SIDED|95.0|0.19|1.38||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -2.26|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner injury % change from baseline||1.38|0.19|<0.05
71033954|NCT02125461|141577534|SUPERIORITY|||||||0.005||||||P-value generated based on z-test where z-test statistic is the ratio of the log-transformed ratio of the cumulative hazards in the 2 treatment arms divided by the square root of the variance.|z-test|The variance was estimated using the delta method and Greenwood's formula.||||||0.005
71033955|NCT02125461|141577535|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.46|0.73|||Log Rank|||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.||0.73|0.46|<0.0001
71033956|NCT02125461|141577536|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.664|TWO_SIDED|95.0|0.77|1.18||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.|Log Rank|||The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.||1.18|0.77|0.664
71033957|NCT02125461|141577537|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.522|TWO_SIDED|95.0|0.88|1.29||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.|Log Rank|||Treatment comparison for dyspnea. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.||1.29|0.88|0.522
71033958|NCT02125461|141577537|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.38|TWO_SIDED|95.0|0.74|1.12||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.|Log Rank|||Treatment comparison for cough. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.||1.12|0.74|0.380
71033959|NCT02125461|141577537|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.048|TWO_SIDED|95.0|0.56|1.0||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.|Log Rank|||Treatment comparison for hemoptysis. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.||1.00|0.56|0.048
71033960|NCT02125461|141577537|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.626|TWO_SIDED|95.0|0.75|1.19||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.|Log Rank|||Treatment comparison for chest pain. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.||1.19|0.75|0.626
71033961|NCT03049748|141577540|OTHER|This is a pilot randomized trial with a purpose of establishing preliminary efficacy data to inform future studies.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71033962|NCT03049748|141577541|OTHER|Same rationale as the primary outcome.|||||>|0.05||||||All p-values across time periods, between groups, were \> .05|Wilcoxon (Mann-Whitney)|||||||>.05
71033963|NCT03049748|141577542|OTHER||||||>|0.05||||||All p values between groups across time periods were \> .05|Wilcoxon (Mann-Whitney)|||||||>.05
71033964|NCT03049748|141577543|OTHER||||||>|0.05||||||All p-values between groups across time periods were \>.05|Wilcoxon (Mann-Whitney)|||||||>.05
71033965|NCT03049748|141577544|OTHER||||||>|0.05||||||All p-values between group differences across time periods were \> .05|Wilcoxon (Mann-Whitney)|||||||>.05
71033966|NCT03049748|141577545|OTHER|||||||0.05||||||Differences in group hospitalization rates p-values: T1 = .093; T2 = .008; T3 = .029|Wilcoxon (Mann-Whitney)|||||||0.05
71033967|NCT00835484|141577546|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.15||||||90.0|91.77|102.83|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||102.83|91.77|
71033968|NCT00835484|141577547|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.8||||||90.0|95.1|106.84|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106.84|95.1|
71095705|NCT02762604|141699834|SUPERIORITY||Mean Difference (Net)|-10.83|STANDARD_ERROR_OF_MEAN|19.03|||TWO_SIDED|95.0|-48.12|26.47|||||The estimate parameter is the difference in change pre to post intervention between Imagined Gait and Visual Imagery group.|Linear mixed effects model were used to compare changes in trails B minus A time pre and post intervention.||26.47|-48.12|
71095706|NCT02762604|141699835|SUPERIORITY||Mean Difference (Net)|-0.93|STANDARD_ERROR_OF_MEAN|0.88|||TWO_SIDED|95.0|-2.65|0.79|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in correct letter number sequences pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||0.79|-2.65|
70975446|NCT01337973|141458574|SUPERIORITY||Coefficient Estimate|1.22|||<|0.001|TWO_SIDED|95.0|0.66|2.28||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.79|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner physical aggression % change from baseline||2.28|0.66|<0.001
70975447|NCT01337973|141458574|SUPERIORITY||Coefficient Estimate|0.8|||<|0.05|TWO_SIDED|95.0|0.32|1.98||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -2.01|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner injury % change from baseline||1.98|0.32|<0.05
70975448|NCT01337973|141458574|SUPERIORITY||Coefficient Estimate|0.6|||<|0.001|TWO_SIDED|95.0|0.25|1.46||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -4.81|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall physical aggression % change from baseline||1.46|0.25|<0.001
70975449|NCT01337973|141458574|SUPERIORITY||Coefficient Estimate|1.05|||<|0.001|TWO_SIDED|95.0|0.45|2.44||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.74|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall injury perpetration % change from baseline||2.44|0.45|<0.001
70975450|NCT01337973|141458574|SUPERIORITY||Coefficient Estimate|0.48|||<|0.01|TWO_SIDED|95.0|0.13|1.78||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -2.59|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner physical aggression % change from baseline||1.78|0.13|<0.01
70975451|NCT01337973|141458574|SUPERIORITY||Coefficient Estimate|0.48|||>|0.05|TWO_SIDED|95.0|0.16|1.47||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -1.81|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner injury % change from baseline||1.47|0.16|>0.05
70975452|NCT01337973|141458574|SUPERIORITY||Coefficient Estimate|1.12|||<|0.001|TWO_SIDED|95.0|0.6|2.08||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -4.10|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner physical aggression % change from baseline||2.08|0.60|<0.001
70975453|NCT01337973|141458574|SUPERIORITY||Coefficient Estimate|1.09|||<|0.01|TWO_SIDED|95.0|0.4|2.95||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.17|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner injury % change from baseline||2.95|0.40|<0.01
70975454|NCT01337973|141458574|SUPERIORITY||||||<|0.001||||||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -4.69||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall physical aggression % change from baseline||||<0.001
70975455|NCT01337973|141458574|SUPERIORITY||||||<|0.01||||||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.32||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall injury % change from baseline||||<0.01
70975456|NCT01337973|141458574|SUPERIORITY||||||<|0.01||||||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -2.90||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner physical aggression % change from baseline||||<0.01
70975457|NCT01337973|141458574|SUPERIORITY||||||>|0.05||||||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z Score: -1.02||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner injury % change from baseline||||>0.05
70975458|NCT01337973|141458574|SUPERIORITY||||||<|0.01||||||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z Score: -4.01||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner physical aggression % change from baseline||||<0.01
70975459|NCT01337973|141458574|SUPERIORITY||||||<|0.01||||||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.21||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall non-partner injury % change from baseline||||<0.01
70975460|NCT01337973|141458575|SUPERIORITY||Coefficient estimate|0.95|||<|0.001|TWO_SIDED|95.0|0.62|1.47||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -3.52|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to heavy drinking % change from baseline"||1.47|0.62|<0.001
70975461|NCT01337973|141458575|SUPERIORITY||coefficient estimate|0.49|||<|0.01|TWO_SIDED|95.0|0.18|1.32||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.98|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to cocaine use % change from baseline"||1.32|0.18|<0.01
70975462|NCT01337973|141458575|SUPERIORITY||coefficient estimate|0.85|||<|0.05|TWO_SIDED|95.0|0.4|1.8||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.13|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to marijuana use % change from baseline"||1.8|0.4|<0.05
70975463|NCT01337973|141458575|SUPERIORITY||coefficient estimate|0.84|||<|0.05|TWO_SIDED|95.0|0.54|1.32||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.48|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to illicit drug use % change from baseline"||1.32|0.54|<0.05
71033969|NCT00835484|141577548|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.39||||||90.0|95.89|107.2|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.2|95.89|
71033970|NCT04383587|141577549|SUPERIORITY||||||>|0.18|||||||Fisher Exact|||Participants were grouped by age (18-35 vs. 36-50 vs. 51-65 vs. \>65), Sex at birth (Female vs. Male). and Occupational Role (Technician vs Anesthesiologist vs Advanced Practice Provider vs. Attendant Aide vs. CRNA vs. OR nurse vs Perfusionist vs Surgeon).||||>0.18
71033971|NCT04994535|141577552|SUPERIORITY||Difference (%)|30.9|||<|0.0001|TWO_SIDED|95.0|24.5|37.4||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||37.4|24.5|<.0001
71033972|NCT04994535|141577553|SUPERIORITY||Difference (%)|38.9|||<|0.0001|TWO_SIDED|95.0|31.3|46.4||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||46.4|31.3|<0.0001
71033973|NCT04994535|141577554|SUPERIORITY||Difference (%)|36.9|||<|0.0001|TWO_SIDED|95.0|29.1|44.7||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||44.7|29.1|<0.0001
71033974|NCT04994535|141577557|SUPERIORITY||Difference (%)|50.2|||<|0.0001|TWO_SIDED|95.0|42.0|58.3||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||58.3|42.0|<.0001
71033975|NCT04994535|141577558|SUPERIORITY||Difference (%)|27.1|||<|0.0001|TWO_SIDED|95.0|18.1|36.1||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||36.1|18.1|<.0001
71033976|NCT04994535|141577559|SUPERIORITY||Difference (%)|35.8|||<|0.0001|TWO_SIDED|95.0|27.4|44.2||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||44.2|27.4|<.0001
71033977|NCT04994535|141577560|SUPERIORITY||Difference (SE)|-4.4|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001|TWO_SIDED|95.0|-5.4|-3.4||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||||-3.4|-5.4|<.0001
71033978|NCT04994535|141577563|SUPERIORITY||Difference (%)|42.9|||<|0.0001|TWO_SIDED|95.0|34.8|51.0||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||51.0|34.8|<0.0001
71033979|NCT04994535|141577564|SUPERIORITY||Difference (%)|49.4|||<|0.0001|TWO_SIDED|95.0|40.8|58.1||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||58.1|40.8|<0.0001
71033980|NCT04994535|141577565|SUPERIORITY||Difference (%)|28.8|||<|0.0001|TWO_SIDED|95.0|19.4|38.2||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||38.2|19.4|<0.0001
70921935|NCT03725722|141334128|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline vIGA-AD score. An event was defined as the first time achieving vIGA-AD.|||||>|0.05||||||The statistical test was not controlled for multiplicity.|Log Rank|||Time to vIGA-AD TS was def. as time from date of first IMP applic. to first assess. of vIGA-AD TS. Subjects without baseline observation were censored at date of first IMP applic. Subjects with baseline observation not achieving vIGA-AD TS during treatment period were censored at date of last visit with a valid post-baseline assess. on or prior to date of discont. of IMP or initiation of rescue med, whichever occurred first. Subjects affected by COVID-19 pandemic were handled in the same manner.||||>0.05
70921936|NCT03725722|141334128|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline vIGA-AD score. An event was defined as the first time achieving vIGA-AD.|||||>|0.05||||||"vIGA-AD was reached in less than 50% of participants, therefore the median time was not estimable.~The statistical test was not controlled for multiplicity."|Log Rank|||Time to vIGA-AD TS was def. as time from date of first IMP applic. to first assess. of vIGA-AD TS. Subjects without baseline observation were censored at date of first IMP applic. Subjects with baseline observation not achieving vIGA-AD TS during treatment period were censored at date of last visit with a valid post-baseline assess. on or prior to date of discont. of IMP or initiation of rescue med, whichever occurred first. Subjects affected by COVID-19 pandemic were handled in the same manner.||||>0.05
70921937|NCT03725722|141334128|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline vIGA-AD score. An event was defined as the first time achieving vIGA-AD.|||||>|0.05||||||The statistical test was not controlled for multiplicity|Log Rank|||Time to vIGA-AD TS was def. as time from date of first IMP applic. to first assess. of vIGA-AD TS. Subjects without baseline observation were censored at date of first IMP applic. Subjects with baseline observation not achieving vIGA-AD TS during treatment period were censored at date of last visit with a valid post-baseline assess. on or prior to date of discont. of IMP or initiation of rescue med, whichever occurred first. Subjects affected by COVID-19 pandemic were handled in the same manner||||>0.05
70921938|NCT03725722|141334128|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline vIGA-AD score. An event was defined as the first time achieving vIGA-AD|||||<|0.001||||||The statistical test was not controlled for multiplicity|Log Rank|||Time to vIGA-AD TS was def. as time from date of first IMP applic. to first assess. of vIGA-AD TS. Subjects without baseline observation were censored at date of first IMP applic. Subjects with baseline observation not achieving vIGA-AD TS during treatment period were censored at date of last visit with a valid post-baseline assess. on or prior to date of discont. of IMP or initiation of rescue med, whichever occurred first. Subjects affected by COVID-19 pandemic were handled in the same manner||||<0.001
70921939|NCT05505045|141334133|OTHER||Cohen's d effect size|0.44|||||TWO_SIDED|95.0|-0.16|1.05||||||||1.05|-.16|
70921940|NCT05505045|141334134|OTHER||Cohen's d effect size|0.42|||||TWO_SIDED|95.0|-0.19|1.03||||||||1.03|-.19|
70921941|NCT05505045|141334135|OTHER||Cohen's d effect size|0.31|||||TWO_SIDED|95.0|-0.3|0.93||||||||0.93|-.30|
70921942|NCT05505045|141334136|OTHER||Cohen's d effect size|-0.42|||||TWO_SIDED|96.0|-1.04|0.21||||||||0.21|-1.04|
70921943|NCT05505045|141334141|OTHER||Cohen's d effect size|0.01|||||TWO_SIDED|95.0|-0.61|0.64||||||||.64|-.61|
70921944|NCT01643070|141334142|SUPERIORITY||Odds Ratio (OR)|1.5||||0.719|TWO_SIDED|95.0|0.346|6.501|||t-test, 1 sided|||||6.501|0.346|0.719
70921945|NCT01600014|141334147|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.44||||0.001|TWO_SIDED|95.0|1.32|4.51||Chi-square test for stratified data with a significance level of 5%. No adjustment for multiple tests was needed, due to the analyses were based on distinct subject groups|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel ratio of clearance rates (Ingenol mebutate relative to Vehicle) adjusted for anatomical location and country||The analysis type was superiority between groups. In total 141 subjects were included||4.51|1.32|0.001
70921946|NCT01600014|141334147|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.37||||0.013|TWO_SIDED|95.0|1.07|5.25||Chi-square test for stratified data with a significance level of 5%. No adjustment for multiple tests was needed, due to the analyses were based on distinct subject groups|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel ratio of clearance rates (Ingenol mebutate relative to Vehicle) adjusted for anatomical location and week of randomisation||The analysis type was superiority between groups. In total 62 subjects were included||5.25|1.07|0.013
70921947|NCT01600014|141334148|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|4.41||||0.016|TWO_SIDED|95.0|1.1|17.62||A closed test procedure was chosen where the evaluation process stopped when the first non-significant results were observed thus securing that the overall significance level did not exceed 5% for multiple testing|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel ratio of clearance rates (Ingenol mebutate relative to Vehicle) adjusted for anatomical location and country||The analysis type was superiority between groups. In total 141 subjects were included||17.62|1.10|0.016
70975464|NCT01337973|141458575|SUPERIORITY||coefficient estimate|1.15|||<|0.001|TWO_SIDED|95.0|0.78|1.71||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -4.94|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to heavy drinking % change from baseline"||1.71|0.78|<0.001
70975465|NCT01337973|141458575|SUPERIORITY||coefficient estimate|0.61|||<|0.05|TWO_SIDED|95.0|0.17|2.16||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.56|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to cocaine use % change from baseline"||2.16|0.17|<0.05
70975466|NCT01337973|141458575|SUPERIORITY||coefficient estimate|1.18|||<|0.01|TWO_SIDED|95.0|0.57|2.44||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.86|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to marijuana use % change from baseline"||2.44|0.57|<0.01
71033981|NCT04994535|141577566|SUPERIORITY||Difference (%)|35.9|||<|0.0001|TWO_SIDED|95.0|27.2|44.6||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||44.6|27.2|<0.0001
70975467|NCT01337973|141458575|SUPERIORITY||coefficient estimate|0.95|||<|0.001|TWO_SIDED|95.0|0.61|1.48||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -3.51|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to illicit drug use % change from baseline"||1.48|0.61|<0.001
71033982|NCT04994535|141577567|SUPERIORITY||Difference (SE)|-4.7|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-5.8|-3.7||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||||-3.7|-5.8|<0.0001
71033983|NCT04994535|141577568|SUPERIORITY||Difference (SE)|-4.9|STANDARD_ERROR_OF_MEAN|0.58|<|0.0001|TWO_SIDED|95.0|-6.0|-3.7||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||Day 30||-3.7|-6.0|<0.0001
71033984|NCT04994535|141577568|SUPERIORITY||Difference (SE)|-4.7|STANDARD_ERROR_OF_MEAN|0.59|<|0.0001|TWO_SIDED|95.0|-5.9|-3.6||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||Day 60||-3.6|-5.9|<0.0001
71033985|NCT04994535|141577568|SUPERIORITY||Difference (SE)|-3.9|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-4.9|-2.8||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||Day 90||-2.8|-4.9|<0.0001
71033986|NCT00905840|141577611|NON_INFERIORITY_OR_EQUIVALENCE|The analysis of the primary outcome variable, was based on a confirmatory non-inferiority test with a one-sided 97.5% confidence interval. The non-inferiority margin for a clinically relevant difference was set at 0.1 mm. For a sample size of st least 73, a paired t-test with a 0.0025 one-sided significant level was calculated to have 80% power to reject the hypothesis that the test is inferior to the standard.|Mean Difference (Final Values)|0.1||||0.025|TWO_SIDED|97.5|0.1|0.3|||Student's t-test|||"Null hypothesis: Change of functional bone level at the test implant 12 month after surgery is more than 0.1 lower (inferior) than change of functional crestal bone level at the control implant 12 month after surgery.~H-1: Change of functional bone level at the tst implant 12 month after surgery is up to 0.1 lower, equal, or higher (not inferior) than change of functional crestal bone level at the control implant 12 month after surgery."||0.3|0.1|0.025
71033987|NCT00905840|141577612|SUPERIORITY_OR_OTHER|||||||0.1573|TWO_SIDED|95.0|||||McNemar|||This analysis is up to 12 month.||||0.1573
70921948|NCT01600014|141334148|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.24||||0.1|TWO_SIDED|95.0|0.78|6.47||A closed test procedure was chosen where the evaluation process stopped when the first non-significant results were observed thus securing that the overall significance level did not exceed 5% for multiple testing|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel ratio of clearance rates (Ingenol mebutate relative to Vehicle) adjusted for anatomical location and country||The analysis type was superiority between groups. In total 62 subjects were included||6.47|0.78|0.10
70975468|NCT01337973|141458575|SUPERIORITY||||||<|0.001||||||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -4.65||"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to heavy drinking % change from baseline"||||<0.001
70975469|NCT01337973|141458575|SUPERIORITY||||||>|0.05||||||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -1.45||"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to cocaine use % change from baseline"||||>0.05
70975470|NCT01337973|141458575|SUPERIORITY||||||>|0.05||||||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -1.5||"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to marijuana use % change from baseline"||||>0.05
70975471|NCT01337973|141458575|SUPERIORITY||||||<|0.05||||||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.58||"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to illicit drug use % change from baseline"||||<0.05
70975472|NCT00254566|141458588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be declared if the lower bound of the 95% CI around the difference in clinical success rates is greater than -10%|Risk Difference (RD)|-0.9||||||95.0|-5.8|3.9|||||Risk difference is the difference in percentage of participants with cure and the 95% Confidence Interval|95% Confidence Interval (CI) for the difference in cure rates will be constructed using a method of linear stratification that weights according to the reciporcal of the variance. Stratification will be by steriod use at time of randomization.||3.9|-5.8|
71033988|NCT00905840|141577613|SUPERIORITY_OR_OTHER|||||||0.3617|TWO_SIDED|||||12 month data Plaque index|Wilcoxon (Mann-Whitney)|||||||0.3617
71033989|NCT00905840|141577613|SUPERIORITY_OR_OTHER|||||||0.7068|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|24 month data Plaque index||||||0.7068
71033990|NCT00905840|141577613|SUPERIORITY_OR_OTHER|||||||0.4312|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|36 month data Plaque Index||||||0.4312
70921949|NCT01600014|141334148|SUPERIORITY_OR_OTHER_LEGACY||Percent cleared subjects|50.0|||||TWO_SIDED|95.0|44.0|56.1|||||Estimation based on completers only.|Subjects randomised to vehicle were not included in the estimate of the overall clearance rate for the repeat-use regimen, from last treatment throught to Month 12. Instead, the subjects randomised to ingenol mebutate were given higher weights to reflect the hypothetical scenario where all randomised subjects were given active treatment during the repeat use cycle||56.1|44.0|
71033991|NCT00905840|141577613|SUPERIORITY_OR_OTHER|||||||0.9933|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|12 month data Sulcus Bleeding Index||||||0.9933
71033992|NCT00905840|141577613|SUPERIORITY_OR_OTHER|||||||0.3667|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|24 month data Sulcus Bleeding Index||||||0.3667
71033993|NCT00905840|141577613|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|36 month data Sulcus Bleeding Index||||||1.0000
70921950|NCT01600014|141334149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.88|||<|0.001|TWO_SIDED|95.0|-1.38|-0.38||A closed test procedure was chosen where the evaluation process stopped when the first non-significant results were observed thus securing that the overall significance level did not exceed 5% for multiple testing|ANCOVA|Analysed using ANCOVA adjusted for anatomical location, country and AK count at randomisation|Using baseline observation carried forward (BOCF) as the imputation method.|The analysis type was superiority between groups. In total 141 subjects were included||-0.38|-1.38|<0.001
70975473|NCT00254566|141458589|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be declared if the lower bound of the 95% CI around the difference in clinical success rates is greater than -10%|Risk Difference (RD)|-2.5||||||95.0|-8.5|3.4|||||Risk difference is the difference in the percentage of participants with Cure and the 95% CI|95% CI for the difference in cure rates will be constructed using a method of linear stratification that weights according to the reciporcal of the variance. Stratification will be by steriod use at time of randomization.||3.4|-8.5|
70975474|NCT00254566|141458590|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be declared if the lower bound of the 95% CI around the difference in clinical success rates is greater than -10%|Risk Difference (RD)|-2.5||||||95.0|-8.5|3.4|||||Risk difference is the difference in percentage of participants with cure and the 95% Confidence|95% CI for the difference in cure rates will be constructed using a method of linear stratification that weights according to the reciprocal of the variance. Stratification will be by steroid use at time of randomization.||3.4|-8.5|
70975475|NCT00254566|141458591|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.6||||||95.0|-4.5|3.3|||||Risk difference is the difference in eradication rates of pathogens by treatment|||3.3|-4.5|
70975476|NCT00254566|141458592|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.33||||0.159||95.0|0.9|2.0||p-value was estimated from Cox's Proportional Hazard model with steriod use and country as factors and baseline FEV1 fitted as covariate|Regression, Cox|||Kaplan-Meier method was used to estimate time taken for 1st 25th quartile of subjects to experience recurrence of AECB. Estimate of median time to event couldn't be calculated because \<50% of subjects in analysis population experienced a recurrence. The ratio of the treatment groups' recurrence rate (hazard ratio) estimated using Cox proportional hazards model adjusting for steroid use, frequency of AECB in previous 12 months, country and baseline Forced expiratory volume in 1 second (FEV1).||2.0|0.9|0.159
70975477|NCT00254566|141458593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.57||95.0|-0.21|0.12|||ANCOVA|Estimated from ANCOVA with treatment, steriod use, and country fitted as factor and baseline CCQ total scores and FEV1 fitted as covariates||||0.12|-0.21|0.57
70975478|NCT00254566|141458593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.82||95.0|-0.13|0.1|||Mixed Models Analysis|Estimated from linear mixed model with treatment, steroid use, FEV1, country and time point as factors and baseline CCQ scores as a covariate||||0.10|-0.13|0.82
70975479|NCT00254566|141458594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.81||95.0|-0.21|0.17|||ANCOVA|Estimated from ANCOVA with treatment, steriod use and country fitted as factors and baseline CCQ total score and FEV1 fitted as covariates||||0.17|-0.21|0.81
70975480|NCT00254566|141458594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.87||95.0|-0.12|0.14|||Mixed Models Analysis|Estimated from linear mixed model with treatment, steroid use, FEV1, country and time point as factors and baseline CCQ scores as a covariate||||0.14|-0.12|0.87
70975481|NCT00254566|141458595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.385||95.0|-0.27|0.1|||ANCOVA|Estimated from ANCOVA with treatment, steriod use and country fitted as factors and baseline CCQ total score and FEV1 fitted as covariates||||0.10|-0.27|0.385
70975482|NCT00254566|141458595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.56||95.0|-0.17|0.09|||Mixed Models Analysis|Estimated from linear mixed model with treatment, steroid use, FEV1, country and time point as factors and baseline CCQ scores as a covariate||||0.09|-0.17|0.56
70975483|NCT00254566|141458596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.62||95.0|-0.26|0.16|||ANCOVA|Estimated from ANCOVA with treatment, steriod use and country fitted as factors and baseline CCQ total score and FEV1 fitted as covariates||||0.16|-0.26|0.62
70975484|NCT00254566|141458596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.8||95.0|-0.18|0.14|||Mixed Models Analysis|Estimated from linear mixed model with treatment, steroid use, FEV1, country and time point as factors and baseline CCQ scores as a covariate||||0.14|-0.18|0.80
70975485|NCT02623335|141458632|SUPERIORITY||Odds Ratio (OR)|1.32||||0.353|TWO_SIDED||||||Mixed Models Analysis|||Options questions||||0.353
70975486|NCT02623335|141458632|SUPERIORITY||Odds Ratio (OR)|0.97||||0.923|TWO_SIDED||||||Mixed Models Analysis|||Expectations questions||||0.923
70975487|NCT02623335|141458632|SUPERIORITY||Odds Ratio (OR)|1.41||||0.255|TWO_SIDED||||||Mixed Models Analysis|||Risks questions||||0.255
70975488|NCT02623335|141458632|SUPERIORITY||Odds Ratio (OR)|239047259.0||||0.094|TWO_SIDED||||||Mixed Models Analysis|||Advance directives questions||||0.094
70975489|NCT02623335|141458633|SUPERIORITY||Effect estimate|-0.04||||0.84|TWO_SIDED||||||Mixed Models Analysis|||Change in scores between T2 and T1||||0.84
70975490|NCT02623335|141458633|SUPERIORITY||Effect estimate|-0.15||||0.645|TWO_SIDED||||||Mixed Models Analysis|||Change in scores between T3 and T1||||0.645
70975491|NCT02623335|141458634|SUPERIORITY||Effect estimate|-0.37||||0.411|TWO_SIDED||||||Mixed Models Analysis|||||||0.411
70975492|NCT02623335|141458635|SUPERIORITY||Odds Ratio (OR)|1.39||||0.412|TWO_SIDED||||||Mixed Models Analysis|||||||0.412
70975493|NCT02623335|141458636|SUPERIORITY||Effect estimate|-0.25||||0.009|TWO_SIDED||||||Mixed Models Analysis|||||||0.009
70975494|NCT02623335|141458637|SUPERIORITY||Effect estimate|-0.72||||0.106|TWO_SIDED||||||Mixed Models Analysis|||6-8 weeks post-enrollment (T2)||||0.106
70975495|NCT02623335|141458637|SUPERIORITY||Effect estimate|-1.12||||0.007|TWO_SIDED||||||Mixed Models Analysis|||3-4 months post-enrollment post-enrollment (T3)||||0.007
70975496|NCT02623335|141458638|SUPERIORITY||Effect estimate|0.97||||0.034|TWO_SIDED||||||Mixed Models Analysis|||6-8 weeks post-enrollment (T2)||||0.034
70975497|NCT02623335|141458638|SUPERIORITY||Effect estimate|1.12||||0.019|TWO_SIDED||||||Mixed Models Analysis|||3-4 months post-enrollment (T3)||||0.019
70975498|NCT02623335|141458639|SUPERIORITY||Effect estimate|1.16||||0.022|TWO_SIDED||||||Mixed Models Analysis|||6-8 weeks post-enrollment (T2)||||0.022
70975499|NCT02623335|141458639|SUPERIORITY||Effect estimate|0.94||||0.053|TWO_SIDED||||||Mixed Models Analysis|||3-4 months post-enrollment post-enrollment (T3)||||0.053
70975500|NCT02623335|141458641|SUPERIORITY||Effect estimate|5.04||||0.07|TWO_SIDED||||||Mixed Models Analysis|||||||0.07
71033994|NCT04813354|141577632|SUPERIORITY||Odds Ratio (OR)|0.11|||<|0.001|TWO_SIDED|95.0|0.01|0.4|||Exact conditional logistic regression||Odds ratio between ELLIPTA DPI and BREEZHALER DPI was calculated using an exact conditional logistic regression model with participant as fixed strata, inhaler and period as fixed effects.|||0.40|0.01|<0.001
70921951|NCT01600014|141334149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.01|||<|0.001|TWO_SIDED|95.0|-1.52|-0.51||A closed test procedure was chosen where the evaluation process stopped when the first non-significant results were observed thus securing that the overall significance level did not exceed 5% for multiple testing|ANCOVA|Sensitivity analysis using complete cases|Sensitivity analysis using complete cases|The analysis type was superiority between groups. In total 141 subjects were included||-0.51|-1.52|<0.001
70921952|NCT01600014|141334149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.69||||0.008|TWO_SIDED|95.0|-1.19|-0.19||Formal statistical significance could not be established because of the closed test procedure where the first secondary endpoint tested (12 months clearance) did not reach statistical significance in the recurrent subgroup|ANCOVA|Analysed using ANCOVA adjusted for anatomical location, country and AK count at randomisation|Using BOCF as the imputation method, the difference in the adjusted mean AK count between the ingenol mebutate and vehicle groups|The analysis type was superiority between groups. In total 62 subjects were included||-0.19|-1.19|0.008
70921953|NCT02975505|141334151|SUPERIORITY||beta|11.7|||<|0.05|TWO_SIDED|95.0|7.5|16.0|||Mixed Models Analysis|||||16|7.5|<0.05
70921954|NCT02975505|141334154|SUPERIORITY||beta|12.5||||0.05|TWO_SIDED|95.0|8.0|16.0|||Mixed Models Analysis|||||16|8|0.05
70921955|NCT01259401|141334156|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED||||||ANCOVA|||||||.04
70921956|NCT01259401|141334157|SUPERIORITY_OR_OTHER_LEGACY|||||||0.061|TWO_SIDED||||||ANCOVA|||||||.061
70921957|NCT05769595|141334170|OTHER||Geometric Mean Ratio|2.51|||||TWO_SIDED|90.0|2.24|2.82|||||Geometric mean ratio is MK-2060/placebo|||2.82|2.24|
70921958|NCT05768373|141334210|NON_INFERIORITY|This study used a non-inferiority margin of 15 mm.|Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-3.4|4.0|||||The difference is 3M Clinpro minus 3M Vanish.|||4.0|-3.4|
70921959|NCT05768373|141334211|NON_INFERIORITY|This study used a non-inferiority margin of 15 mm.|Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-2.6|5.3|||||The difference is 3M Clinpro minus 3M Vanish.|||5.3|-2.6|
70921960|NCT05768373|141334212|NON_INFERIORITY|This study used a non-inferiority margin of 15 mm.|Mean Difference (Final Values)|1.7|||||TWO_SIDED|95.0|-3.2|6.7|||||The difference is 3M Clinpro minus 3M Vanish.|||6.7|-3.2|
70921961|NCT05768373|141334213|NON_INFERIORITY|This study used a non-inferiority margin of 15 mm.|Mean Difference (Final Values)|2.2|||||TWO_SIDED|95.0|-3.0|7.4|||||The difference is 3M Clinpro minus 3M Vanish.|||7.4|-3.0|
70921962|NCT05768373|141334214|NON_INFERIORITY|This study used a non-inferiority margin of 15 mm.|Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0|-4.4|8.2|||||The difference is 3M Clinpro minus 3M Vanish.|||8.2|-4.4|
70921963|NCT03398200|141334226|SUPERIORITY|||||||0.89|||||||Regression, Cox|1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model||||||0.89
70921964|NCT03398200|141334227|SUPERIORITY|||||||0.03|||||||Regression, Cox|1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model||||||0.03
70921965|NCT03398200|141334228|SUPERIORITY|||||||0.35|||||||Regression, Cox|1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model||||||0.35
70921966|NCT03398200|141334229|SUPERIORITY|||||||0.77|||||||Regression, Cox|1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model||||||0.77
70921967|NCT03398200|141334230|SUPERIORITY|||||||0.5|||||||Regression, Cox|1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model||||||0.50
70921968|NCT03398200|141334231|SUPERIORITY|||||||0.76|||||||Regression, Cox|1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model||||||0.76
70921969|NCT04605198|141334290|SUPERIORITY|A multilevel model was constructed. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention, primary endpoint\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was also included as a fixed-effect. An independent covariance pattern was specified as final models were random-intercept only.|Mean Difference (Net)|-0.58||||0.846|TWO_SIDED|95.0|-6.46|5.29|||Mixed Models Analysis||The estimate represents the interaction term for group by time interaction for the immediate follow-up, with the control group coded 0 and the intervention group coded as 1.|||5.29|-6.46|.846
70921970|NCT04605198|141334291|SUPERIORITY||Mean Difference (Net)|-1.88||||0.139|TWO_SIDED|95.0|-4.36|0.6|||Mixed Models Analysis||The estimate represents the interaction term for group by time interaction for the immediate follow-up, with the control group coded 0 and the intervention group coded as 1.|A multilevel model was constructed. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention, primary endpoint\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was also included as a fixed-effect. An independent covariance pattern was specified as final models were random-intercept only.||0.60|-4.36|.139
70921971|NCT04605198|141334292|SUPERIORITY||Mean Difference (Net)|-0.12||||0.222|TWO_SIDED|95.0|-1.21|0.97|||Mixed Models Analysis||The estimate represents the interaction term for group by time interaction for the immediate follow-up, with the control group coded 0 and the intervention group coded as 1.|A multilevel model was constructed. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention, primary endpoint\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was also included as a fixed-effect. An independent covariance pattern was specified as final models were random-intercept only.||0.97|-1.21|.222
71033995|NCT04813354|141577634|OTHER||Odds Ratio (OR)|0.25||||0.005|TWO_SIDED|95.0|0.03|0.74|||Exact conditional logistic regression||Odds ratio between ELLIPTA DPI and BREEZHALER DPI was calculated using an exact conditional logistic regression model with participant as fixed strata, inhaler and period as fixed effects.|||0.74|0.03|0.005
71033996|NCT04813354|141577643|OTHER||Mean Difference (Final Values)|27.63|||<|0.001|TWO_SIDED|95.0|21.31|33.96|||Paired samples t-test|||||33.96|21.31|<0.001
70975501|NCT03683394|141458642|SUPERIORITY||Mean Difference (Net)|0.15||||0.008|TWO_SIDED|95.0|0.04|0.26||Adjusted for baseline value, sex, race/ethnicity education, comorbidity score and phone assessment.|Mixed Models Analysis|Treatment effects were estimated using linear mixed models (LMMs) for the changes from baseline to each follow-up assessment.||||0.26|0.04|0.008
70975502|NCT03683394|141458643|SUPERIORITY||Mean Difference (Net)|0.11||||0.002|TWO_SIDED|95.0|0.02|0.21||Adjusted for baseline value, sex, race/ethnicity education, comorbidity score and phone assessment.|Mixed Models Analysis|Treatment effects were estimated using linear mixed models (LMMs) for the changes from baseline to each follow-up assessment.||||0.21|0.02|0.002
70975503|NCT03683394|141458644|SUPERIORITY||Mean Difference (Net)|1.11||||0.03|TWO_SIDED|95.0|0.08|2.14||Adjusted for baseline value, sex, race/ethnicity education, comorbidity score and phone assessment.|Mixed Models Analysis|Treatment effects were estimated using linear mixed models (LMMs) for the changes from baseline to each follow-up assessment.||||2.14|0.08|0.03
70975504|NCT03683394|141458645|SUPERIORITY||Odds Ratio (OR)|0.68||||0.52|TWO_SIDED|95.0|0.19|2.19||Adjusted for age and sex.|Fisher Exact|In an exploratory outcome, we examined incidence of a low CASI score or a diagnosis of MCI or dementia by treatment group.||||2.19|0.19|0.52
70921972|NCT04605198|141334293|SUPERIORITY||Odds Ratio, log|-1.76||||0.166|TWO_SIDED|95.0|-4.26|0.73|||Mixed Models Analysis||The estimate represents the interaction term for group by time interaction for the immediate follow-up, with the control group coded 0 and the intervention group coded as 1.|A multilevel model was constructed using a logit distribution. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was included as a fixed-effect. An independent covariance pattern was specified. Final models were random-intercept only.||0.73|-4.26|0.166
70921973|NCT04605198|141334294|SUPERIORITY||Mean Difference (Net)|-0.52||||0.737|TWO_SIDED|95.0|-3.57|2.53|||Mixed Models Analysis||The estimate represents the interaction term for group by time interaction for the immediate follow-up, with the control group coded 0 and the intervention group coded as 1.|A multilevel model was constructed. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention, primary endpoint\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was also included as a fixed-effect. An independent covariance pattern was specified as final models were random-intercept only.||2.53|-3.57|.737
70921974|NCT04605198|141334295|SUPERIORITY||Mean Difference (Net)|-2391.98||||0.024|TWO_SIDED|95.0|-4471.46|-312.49|||Mixed Models Analysis||The estimate represents the interaction term for group by time interaction for the immediate follow-up, with the control group coded 0 and the intervention group coded as 1.|A multilevel model was constructed. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention, primary endpoint\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was also included as a fixed-effect. An independent covariance pattern was specified as final models were random-intercept only.||-312.49|-4471.46|.024
70921975|NCT04038957|141334296|SUPERIORITY|||||||0.0072||||||A p-value of p\<0.05 will be considered as significant.|Repeated Measures ANOVA|||To examine the primary outcome, the effects of SEP-363856 on the striatum, a repeated measures ANOVA model will be build using the baseline and on-treatment kicer values of each striatal subregion.||||0.0072
70921976|NCT03821844|141334297|SUPERIORITY||marginal interaction effect|1.33|STANDARD_ERROR_OF_MEAN|1.38|<|0.05|TWO_SIDED|95.0|-1.37|4.03|||Differences-in-Differences regression||||"Fixed effects: age, sex, race, activities of daily living score, cognitive function score, psychotic disorder, bipolar disease, depression, anxiety, dementia, antidepressant use, antianxietal use, antipsychotic use, corporation, time from Minimum Data Set (MDS) collection to Cohen-Mansfield Agitation Inventory (CMAI) score (exclusive to CMAI model), baseline Agitation and Reactive Behavior Scale (ARBS) (exclusive to CMAI model), baseline CMAI (exclusive to ARBS and ARBS-CMAI model), indicator of baseline/follow-up score, treatment group, interaction of baseline/follow-up measure, and treatment group.~Random effects: random intercept for nursing home, random intercept for the interaction of baseline/follow-up measure and nursing home, random intercept for data collector (exclusive to CMAI model), and random intercept for individual."|4.03|-1.37|< 0.05
70921977|NCT03821844|141334298|SUPERIORITY||marginal interaction effect|0.06|||<|0.05|TWO_SIDED|95.0|0.03|0.09|||Differences-in-Differences regression||Reported estimation details pertain to the None category.||"The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models. All models adjust for resident baseline covariates, an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. The reference category for the multinomial model for each outcome is None. To address baseline differences in the proportion of individuals at each level of the ordinal outcomes between treatment and control groups, we report the marginal time by intervention interaction."|0.09|0.03|< 0.05
70975505|NCT03072160|141458663|OTHER|||||||0.926||||||CD4|Wilcoxon signed-rank test||||A change is defined as being statistically significant (p\>0.05).|||0.926
70975506|NCT03072160|141458663|OTHER|||||||0.445||||||CD8|Wilcoxon signed-rank test||||A change is defined as being statistically significant (p\>0.05).|||0.445
70975507|NCT03072160|141458663|OTHER|||||||0.21||||||Tregs|Wilcoxon signed-rank test||||A change is defined as being statistically significant (p\>0.05).|||0.210
71095707|NCT02762604|141699836|SUPERIORITY||Mean Difference (Net)|1.39|STANDARD_ERROR_OF_MEAN|12.95|||TWO_SIDED|95.0|-24.0|26.78|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in Stroop interference pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||26.78|-24.00|
70975508|NCT03072160|141458663|OTHER|||||||0.78||||||Natural Killer (NK) cells|Wilcoxon signed-rank test||||A change is defined as being statistically significant (p\>0.05).|||0.780
70975509|NCT01058096|141458672|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.3||||0.0004|TWO_SIDED|95.0|-6.7|-1.9|||Mixed Models Analysis||cariprazine - placebo|||-1.9|-6.7|0.0004
70975510|NCT01058096|141458673|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.4||||0.0027|TWO_SIDED|95.0|-0.7|-0.1|||MMRM analysis||cariprazine - placebo|||-0.1|-0.7|0.0027
70921978|NCT03821844|141334299|SUPERIORITY||Marginal Interaction Effect|-0.11|STANDARD_ERROR_OF_MEAN|0.1|<|0.05|TWO_SIDED|95.0|-0.3|0.08|||Differences-in-Differences regression||||"Fixed effect covariates: age, sex, race, activities of daily living score, cognitive function score, psychotic disorder, bipolar disease, depression, anxiety, dementia, antidepressant use, antianxietal use, antipsychotic use, nursing home corporation, time from Minimum Data Set (MDS) collection to Cohen-Mansfield Agitation Inventory (CMAI) score (exclusive to CMAI model), baseline Agitation and Reactive Behavior Score (ARBS) (exclusive to CMAI model), baseline CMAI (exclusive to ARBS and ARBS-CMAI model), indicator of baseline/follow-up score, treatment group, interaction of baseline/follow-up measure, and treatment group.~Random effects: random intercept for nursing home, random intercept for the interaction of baseline/follow-up measure and nursing home, random intercept for data collector (exclusive to CMAI model), and random intercept for individual."|0.08|-0.30|< 0.05
70921979|NCT03821844|141334300|SUPERIORITY||average marginal effect|-3.61|STANDARD_ERROR_OF_MEAN|1.85|<|0.05|TWO_SIDED|95.0|-7.22|0.0|||Differences-in-Differences regression||||Variables included in the model: baseline medication use, age, sex, race, activities of daily living score, cognitive function score, psychotic diagnosis, depression, anxiety, dementia, asthma, agitation and reactive behavior (ARBS) score, date of assessment, treatment group, and facility-level random effect.|0.00|-7.22|< 0.05
70921980|NCT03821844|141334301|SUPERIORITY||average marginal effect|-3.47|STANDARD_ERROR_OF_MEAN|2.08|<|0.05|TWO_SIDED|95.0|-7.55|0.06|||Differences-in-Differences regression||||Variables included in the model: baseline medication use, age, sex, race, activities of daily living score, cognitive function score, psychotic diagnosis, depression, anxiety, dementia, asthma, agitation and reactive behavior (ARBS) score, date of assessment, treatment group, and facility-level random effect.|0.06|-7.55|< 0.05
70921981|NCT03821844|141334302|SUPERIORITY||average marginal effect|-1.26|STANDARD_ERROR_OF_MEAN|2.05|<|0.05|TWO_SIDED|95.0|-5.28|2.76|||Differences-in-Differences regression||||Variables included in the model: baseline medication use, age, sex, race, activities of daily living score, cognitive function score, psychotic diagnosis, depression, anxiety, dementia, asthma, agitation and reactive behavior (ARBS) score, date of assessment, treatment group, and facility-level random effect.|2.76|-5.28|< 0.05
70921982|NCT03821844|141334304|SUPERIORITY||average marginal effect|-0.22|||<|0.05|TWO_SIDED|95.0|-1.14|0.7|||Differences-in-Differences regression||||Multilevel regression with covariates' adjustments was used to estimate the impact of the resident being in a treatment versus control nursing home on depressive symptoms.|0.70|-1.14|< 0.05
70921983|NCT03821844|141334305|SUPERIORITY||marginal interaction effect|0.0|||<|0.05|TWO_SIDED|95.0|-0.03|0.02|||Differences-in-Differences regression||Reported estimation details pertain to the None category.||The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment versus control nursing home had on the behaviors of nursing home residents. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. To address baseline differences in the proportion of individuals at each level of the ordinal outcomes between treatment and control groups, we report the marginal time by intervention interaction.|0.02|-0.03|< 0.05
70921984|NCT03821844|141334306|SUPERIORITY||marginal interaction effect|0.05|||<|0.05|TWO_SIDED|95.0|0.02|0.07|||Differences-in-Differences regression||||The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment versus control nursing home had on the moods of nursing home residents. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. We report the marginal time by intervention interaction.|0.07|0.02|< 0.05
70975511|NCT04276207|141458674|SUPERIORITY||Mean Difference (Final Values)|-0.377||||0.145|TWO_SIDED|95.0|-0.896|0.142|||Mixed Models Analysis|||||0.142|-0.896|0.1450
70975512|NCT04276207|141458675|SUPERIORITY||Mean Difference (Final Values)|-0.262||||0.001|TWO_SIDED|95.0|-0.406|-0.117|||Mixed Models Analysis|||||-0.117|-0.406|0.0010
70975513|NCT04276207|141458676|SUPERIORITY||Mean Difference (Final Values)|-12.61||||0.0173|TWO_SIDED|95.0|-22.73|-2.49|||Mixed Models Analysis|||Day 1||-2.49|-22.73|0.0173
70975514|NCT04276207|141458676|SUPERIORITY||Mean Difference (Final Values)|-5.75||||0.0243|TWO_SIDED|95.0|-10.69|0.81|||Mixed Models Analysis|||Day 2||0.81|-10.69|0.0243
70975515|NCT04276207|141458677|SUPERIORITY|||||||0.945|||||||Mixed Models Analysis|||Day 1||||0.945
70975516|NCT04276207|141458677|SUPERIORITY|||||||0.888|||||||Mixed Models Analysis|||Day 2||||0.888
70975517|NCT05099640|141458733|OTHER||LS Mean Difference|-395.87|STANDARD_ERROR_OF_MEAN|33.848|<|0.0001|TWO_SIDED|95.0|-463.07|-328.66|||Mixed Models Analysis|||||-328.66|-463.07|<0.0001
70975518|NCT05099640|141458734|OTHER||LS Mean Difference|-64.22|STANDARD_ERROR_OF_MEAN|4.973|<|0.0001|TWO_SIDED|95.0|-74.09|-54.35|||Mixed Models Analysis|||||-54.35|-74.09|<0.0001
70975519|NCT05099640|141458735|OTHER||Odds Ratio (OR)|30.33|||<|0.0001|TWO_SIDED|95.0|5.3|294.24|||Chi-squared|||||294.24|5.30|<0.0001
70975520|NCT05099640|141458736|OTHER||Odds Ratio (OR)|51.54|||<|0.0001|TWO_SIDED|95.0|12.28|245.34|||Chi-squared|||||245.34|12.28|<0.0001
70975521|NCT05099640|141458737|OTHER||LS Mean Difference|-289.89|STANDARD_ERROR_OF_MEAN|33.44|<|0.0001|TWO_SIDED|95.0|-356.29|-223.5|||Mixed Models Analysis|||Weeks 1 and 2: Sepiapterin vs. Placebo||-223.50|-356.29|<0.0001
70975522|NCT05099640|141458737|OTHER||LS Mean Difference|-375.47|STANDARD_ERROR_OF_MEAN|30.424|<|0.0001|TWO_SIDED|95.0|-435.88|-315.06|||Mixed Models Analysis|||Weeks 3 and 4: Sepiapterin vs. Placebo||-315.06|-435.88|<0.0001
70975523|NCT05099640|141458737|OTHER||LS Mean Difference|-395.87|STANDARD_ERROR_OF_MEAN|33.848|<|0.0001|TWO_SIDED|95.0|-463.07|-328.66|||Mixed Models Analysis|||Weeks 5 and 6: Sepiapterin vs. Placebo||-328.66|-463.07|<0.0001
70975524|NCT05099640|141458738|OTHER||LS Mean Difference|-42.52|STANDARD_ERROR_OF_MEAN|6.008|<|0.0001|TWO_SIDED|95.0|-54.45|-30.59|||Mixed Models Analysis|||Weeks 1 and 2: Sepiapterin vs. Placebo||-30.59|-54.45|<0.0001
70975525|NCT05099640|141458738|OTHER||LS Mean Difference|-61.03|STANDARD_ERROR_OF_MEAN|4.531|<|0.0001|TWO_SIDED|95.0|-70.02|-52.03|||Mixed Models Analysis|||Weeks 3 and 4: Sepiapterin vs. Placebo||-52.03|-70.02|<0.0001
70975526|NCT05099640|141458738|OTHER||LS Mean Difference|-64.22|STANDARD_ERROR_OF_MEAN|4.973|<|0.0001|TWO_SIDED|95.0|-74.09|-54.35|||Mixed Models Analysis|||Weeks 5 and 6: Sepiapterin vs. Placebo||-54.35|-74.09|<0.0001
70975527|NCT05099640|141458743|OTHER||LS Mean Difference|-492.23|STANDARD_ERROR_OF_MEAN|55.588|<|0.0001|TWO_SIDED|95.0|-614.59|-369.87|||Mixed Models Analysis|||||-369.87|-614.59|<0.0001
70975528|NCT05099640|141458744|OTHER||LS Mean Difference|-74.73|STANDARD_ERROR_OF_MEAN|10.436|<|0.0001|TWO_SIDED|95.0|-97.72|-51.74|||Mixed Models Analysis|||||-51.74|-97.72|<0.0001
70975529|NCT00236080|141458751|NON_INFERIORITY_OR_EQUIVALENCE|Number of participants analyzed was determined by those participants who had at least 1 postbaseline efficacy assessment. Sample size requirements were not based on statistical considerations. There were 20 patients in each of the 5 treatment groups, for a total of 100 patients. It is expected that the sample size will provide sufficient information for describing the specified evaluations.||||||0.1236||||||The p-value of Overall Treatment to Placebo|ANCOVA|This analysis adjusted for the difference among the treatment groups at baseline.||Sample size requirements were not based on statistical considerations. The null hypothesis was Ho: μplacebo = μ150 = μ200 = μ250 = μprovigil versus Ha: at least 2 of the means are different, where μ represented the change from baseline to the endpoint.||||0.1236
70975530|NCT00236080|141458752|NON_INFERIORITY_OR_EQUIVALENCE|Using the adjusted p value from Tukey's least significant difference (LSD) test for armodafinil at 200 mg/day. Sample size requirements were not based on statistical considerations. There were 20 patients in each of the 5 treatment groups, for a total of 100 patients.||||||0.0945||||||The p-value of Overall Treatment to Placebo|ANCOVA|||Sample size requirements were not based on statistical considerations. The null hypothesis was Ho: μplacebo = μ150 = μ200 = μ250 = μprovigil versus Ha: at least 2 of the means are different, where μ represented the change from baseline to the endpoint .||||0.0945
71033997|NCT02964039|141577662|SUPERIORITY|||||||0.047||||||A priori threshold: 0.05|ANOVA|0.047 is the main effect of group from a 2-way ANOVA that also included time (p=0.77) as a within-subjects factor.||||||0.047
71033998|NCT02964039|141577663|SUPERIORITY|||||||0.16||||||A priori threshold: 0.05|ANOVA|0.16 is the main effect of group from a 2-way ANOVA that also included time (p=0.023) as a within-subjects factor.||||||0.16
71033999|NCT02964039|141577664|SUPERIORITY|||||||0.64||||||A priori threshold: 0.05|ANOVA|0.64 is the main effect of group from a 2-way ANOVA that also included time (p=0.024) as a within-subjects factor.||||||0.64
71034000|NCT02964039|141577665|SUPERIORITY|||||||0.92||||||A priori threshold: 0.92|ANOVA|0.92 is the main effect of group from a 2-way ANOVA that also included time (p=0.076) as a within-subjects factor.||||||0.92
71034001|NCT02964039|141577666|SUPERIORITY||||||>=|0.22||||||A priori threshold: 0.05|Mixed Models Analysis|We compared incident rates assuming a negative binomial distribution with leas squares means estimates predicted via generalized linear model.||||||>=0.22
71034002|NCT02964039|141577667|SUPERIORITY|||||||0.99||||||A priori threshold: 0.05|Chi-squared|||||||0.99
71034003|NCT01172145|141577690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.385|STANDARD_ERROR_OF_MEAN|4.86||0.181|TWO_SIDED|95.0|-16.86|3.4|||t-test, 2 sided|||||3.40|-16.86|0.181
70975531|NCT03604445|141458759|OTHER||Probability of DLT rate in [0.16, 0.33)|0.0|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0|||
70975532|NCT03604445|141458759|OTHER||Probability of DLT rate in [0.16, 0.33)|0.0|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0|||
70975533|NCT03604445|141458759|OTHER||Probability of DLT rate in [0.16, 0.33)|0.0|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0|||
70975534|NCT03604445|141458759|OTHER||Probability of DLT rate in [0.16, 0.33)|0.0|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0|||
70975535|NCT03604445|141458759|OTHER||Probability of DLT rate in [0.16, 0.33)|0.0|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0|||
71034004|NCT02354339|141577701|SUPERIORITY|||||||0.24||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of fasting glucose on Irvingia gabonensis group||||0.240
71034005|NCT02354339|141577701|SUPERIORITY|||||||0.85||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of fasting glucose on placebo group||||0.850
71034006|NCT02354339|141577702|SUPERIORITY|||||||0.012||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of triglycerides on Irvingia gabonensis group||||0.012
71034007|NCT02354339|141577702|SUPERIORITY|||||||0.391||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of triglycerides on placebo group||||0.391
71034008|NCT02354339|141577703|SUPERIORITY|||||||0.206||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of HDL-c on Irvingia gabonensis group||||0.206
71034009|NCT02354339|141577703|SUPERIORITY|||||||0.721||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of HDL-c on placebo group||||0.721
71034010|NCT02354339|141577704|SUPERIORITY|||||||0.371||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of systolic blood pressure on Irvingia gabonensis group||||0.371
71034011|NCT02354339|141577704|SUPERIORITY|||||||0.238||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of systolic blood pressure on placebo group||||0.238
71034012|NCT02354339|141577705|SUPERIORITY|||||||0.452||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of diastolic blood pressure on Irvingia gabonensis group||||0.452
71034013|NCT02354339|141577705|SUPERIORITY|||||||0.801||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of diastolic blood pressure on placebo group||||0.801
71034014|NCT02354339|141577706|SUPERIORITY|||||||0.005||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of waist circumference on Irvingia gabonensis group||||0.005
71034015|NCT02354339|141577706|SUPERIORITY|||||||0.752||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of waist circumference on placebo group||||0.752
71034016|NCT02354339|141577707|SUPERIORITY|||||||0.791|||||||Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of first phase of insulin secretion on Irvingia gabonensis group||||0.791
71034017|NCT02354339|141577707|SUPERIORITY|||||||0.91||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of first phase of insulin secretion on placebo group||||0.910
71034018|NCT02354339|141577708|SUPERIORITY|||||||0.458||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total insulin secretion on Irvingia gabonensis group||||0.458
71034019|NCT02354339|141577708|SUPERIORITY|||||||0.953||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total insulin secretion on placebo group||||0.953
70975536|NCT03604445|141458759|OTHER||Probability of DLT rate in [0.16, 0.33)|0.003|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0|||
70975537|NCT03604445|141458759|OTHER||Probability of DLT rate in [0.16, 0.33)|0.035|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0.001|||
70975538|NCT03604445|141458759|OTHER||Probability of DLT rate in [0.16, 0.33)|0.176|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0.018|||
70975539|NCT03604445|141458759|OTHER||Probability of DLT rate in [0.16, 0.33)|0.129|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0.83|||
70975540|NCT01890421|141458808|SUPERIORITY||Sensitivity Difference|-0.7||||0.8694|ONE_SIDED|95.0|-8.5||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 1 for presence of a myocardial perfusion defect indicating significant cad per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - primary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 1.|||-8.5|0.8694
70975541|NCT01890421|141458808|SUPERIORITY||Sensitivity Difference|29.1|||<|0.0001|ONE_SIDED|95.0|21.7||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 2 for presence of a myocardial perfusion defect indicating significant cad per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - primary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 2.|||21.7|<0.0001
70975542|NCT01890421|141458808|SUPERIORITY||Sensitivity Difference|24.1|||<|0.0001|ONE_SIDED|95.0|16.6||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 3 for presence of a myocardial perfusion defect indicating significant cad per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - primary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 3.|||16.6|<0.0001
70975543|NCT01890421|141458809|SUPERIORITY||Sensitivity Difference]|7.4||||0.0455|ONE_SIDED|95.0|0.5||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 1 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - additional secondary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 1.|||0.5|0.0455
70975544|NCT01890421|141458809|SUPERIORITY||Sensitivity Difference]|34.3|||<|0.0001|ONE_SIDED|95.0|25.2||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 2 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - additional secondary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 2.|||25.2|<0.0001
70975545|NCT01890421|141458809|SUPERIORITY||Sensitivity Difference|30.6|||<|0.0001|ONE_SIDED|95.0|21.7||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 3 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - additional secondary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 3.|||21.7|<0.0001
70975546|NCT01890421|141458814|SUPERIORITY||Sensitivity Difference|27.9|||<|0.0001|TWO_SIDED|95.0|18.5|35.8|||McNemar 2-sided test,alpha level of 5%|||Statistical analysis 1 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - secondary analysis of sensitivity comparison based on investigator's assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI. Maximum stenosis severity at least \>=50% by QCA.||35.8|18.5|<0.0001
70975547|NCT01890421|141458814|SUPERIORITY||Sensitivity Difference|27.9|||<|0.0001|TWO_SIDED|95.0|19.9|34.4|||McNemar 2-sided test,alpha level of 10%|||Statistical analysis 2 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - secondary analysis of sensitivity comparison based on investigator's assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI. Maximum stenosis severity at least \>=50% by QCA.||34.4|19.9|<0.0001
70975548|NCT03550066|141458860|NON_INFERIORITY|The non-inferiority limit, d, is selected as the largest difference that is clinically acceptable. Here the non-inferiority limit is d=.6 (a medium to large effect size).||||||0.18||||||Threshold for statistical significance: \<.05|t-test, 2 sided|||||||0.18
70975549|NCT00428597|141458863|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.418||||0.000118|TWO_SIDED|95.0|0.263|0.662||Log-rank test statistic and 2-sided p-value from the unstratified log-rank test|Log Rank||Hazard ratio based on the Cox Proportional hazards model|||0.662|0.263|0.000118
70975550|NCT00428597|141458864|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|9.3|||||TWO_SIDED|95.0|4.1|17.5|||||Confidence interval (CI) using exact method based on binomial distribution.|||17.5|4.1|
70975551|NCT00428597|141458867|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.409||||0.0204|TWO_SIDED|95.0|0.187|0.894||2-sided p-value from the unstratified log-rank test.|Log Rank||Hazard ratio based on the Cox Proportional hazards model.|||0.894|0.187|0.0204
70921985|NCT03821844|141334307|SUPERIORITY||marginal interaction effect|-0.01|||<|0.05|TWO_SIDED|95.0|-0.03|0.01|||Differences-in-Differences regression||||The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment versus control nursing home had on the moods of nursing home residents. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. We report the marginal time by intervention interaction.|0.01|-0.03|< 0.05
70921986|NCT03821844|141334308|SUPERIORITY||average marginal effect|-0.01|||<|0.05|TWO_SIDED|95.0|-0.04|0.01|||Differences-in-Differences regression||||The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment versus control nursing home had on the moods of nursing home residents. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. We report the marginal time by intervention interaction.|0.01|-0.04|< 0.05
70921987|NCT03821844|141334309|SUPERIORITY||marginal interaction effect|0.01|||<|0.05|TWO_SIDED|95.0|-0.02|0.03|||Differences-in-Differences regression||||The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment versus control nursing home had on the moods of nursing home residents. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. We report the marginal time by intervention interaction.|0.03|-0.02|< 0.05
70921988|NCT03821844|141334310|SUPERIORITY||marginal interaction effect|-0.02|||<|0.05|TWO_SIDED|95.0|-0.05|0.01|||Differences-in-Differences regression||||The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment vs. control NH had on the behaviors and moods of NH residents. The models were implemented separately for each mood. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. To address baseline differences in the proportion of individuals at each level of the ordinal outcomes between treatment and control groups, we report the marginal time by intervention interaction. We will refer to this estimand as the marginal interaction effect (MIE), which is sometimes known as the Difference in Differences estimand.|0.01|-0.05|< 0.05
70921989|NCT01998984|141334315|SUPERIORITY||Relative risk|2.97||||0.18|TWO_SIDED|95.0|0.6|14.74||P-value was adjusted for analysis site using Rubin's pooling methodology after log transformation of RR (relative risk) of each imputation. Complete clearance relative to vehicle group and 2-day group.|Cochran-Mantel-Haenszel||Relative risk and confidence interval were adjusted for analysis site using Rubin's pooling methodology after log transformation of RR of each imputation. Complete clearance relative to vehicle group and 2-day group.|"Treatment comparison based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.~Cochran-Mantel-Haenszel logit estimators were used for comparisons with vehicle due to absence of cleared participant in the vehicle group."||14.74|0.60|0.18
70921990|NCT01998984|141334315|SUPERIORITY||Relative risk|3.51||||0.051|TWO_SIDED|95.0|1.0|12.41||P-value was adjusted for analysis site using Rubin's pooling methodology after log transformation of RR (relative risk) of each imputation. Complete clearance relative to vehicle group and 2-day group.|Cochran-Mantel-Haenszel||Relative risk and confidence interval were adjusted for analysis site using Rubin's pooling methodology after log transformation of RR of each imputation. Complete clearance relative to vehicle group and 2-day group.|"Treatment comparison based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.~Cochran-Mantel-Haenszel logit estimators were used for comparisons with vehicle due to absence of cleared subject in the vehicle group.~Type I error not controlled."||12.41|1.00|0.051
70921991|NCT01998984|141334315|SUPERIORITY||Relative risk|0.47||||0.25|TWO_SIDED|95.0|0.13|1.68||P-value was adjusted for analysis site using Rubin's pooling methodology after log transformation of RR (relative risk) of each imputation. Complete clearance relative to vehicle group and 2-day group.|Mantel Haenszel||Relative risk and confidence interval were adjusted for analysis site using Rubin's pooling methodology after log transformation of RR of each imputation. Complete clearance relative to vehicle group and 2-day group.|"Treatment comparison based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.~Type I error not controlled. Mantel-Haenszel estimators were used."||1.68|0.13|0.25
70921992|NCT01998984|141334316|SUPERIORITY||Ratio of adjusted mean|0.4|||<|0.001|TWO_SIDED|95.0|0.32|0.51||P-value was from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.|Negative binomial regression||Estimation parameter and confidence interval were from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.|||0.51|0.32|<0.001
70921993|NCT01998984|141334316|SUPERIORITY||Ratio of adjusted mean|0.36|||<|0.001|TWO_SIDED|95.0|0.29|0.45||P-value was from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.|Negative binomial regression||Estimation parameter and confidence interval were from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.|||0.45|0.29|<0.001
71034020|NCT02354339|141577709|SUPERIORITY|||||||0.47||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of insulin sensitivity on Irvingia gabonensis group||||0.470
70921994|NCT01998984|141334316|SUPERIORITY||Ratio of adjusted mean|0.89||||0.36|TWO_SIDED|95.0|0.7|1.14||P-value was from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.|Negative binomial regression||Estimation parameter and confidence interval were from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.|||1.14|0.70|0.36
70975552|NCT00428597|141458868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1543||||0.6799|TWO_SIDED|95.0|-4.3|6.6||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||6.6|-4.3|0.6799
70975553|NCT00428597|141458869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4404||||0.6058|TWO_SIDED|95.0|-6.9|4.0||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||4|-6.9|0.6058
70975554|NCT00428597|141458870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5575||||0.3008|TWO_SIDED|95.0|-10.3|3.2||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||3.2|-10.3|0.3008
70975555|NCT00428597|141458871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7911||||0.323|TWO_SIDED|95.0|-2.8|8.3||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||8.3|-2.8|0.3230
70975556|NCT00428597|141458872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5113||||0.7113|TWO_SIDED|95.0|-6.5|9.5||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||9.5|-6.5|0.7113
70921995|NCT01998984|141334317|SUPERIORITY||Relative risk|32.26|||<|0.001|TWO_SIDED|95.0|4.39|236.8||P value adjusted for analysis site.|Cochran-Mantel-Haenszel||Relative risk and confidence interval were adjusted for analysis site and were Mantel-Haenszel estimators. Relative risk of partial clearance relative to vehicle group.|The treatment comparison was based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.||236.8|4.39|<0.001
70921996|NCT01998984|141334317|SUPERIORITY||Relative risk|25.2||||0.002|TWO_SIDED|95.0|3.39|187.4||Adjusted for analysis site. Relative risk of partial clearance relative to vehicle group.|Cochran-Mantel-Haenszel||Relative risk and confidence interval were adjusted for analysis site and were Mantel-Haenszel estimators. Relative risk of partial clearance relative to vehicle group.|The treatment comparison was based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.||187.4|3.39|0.002
70921997|NCT01998984|141334317|SUPERIORITY||Relative risk|1.2||||0.28|TWO_SIDED|95.0|0.86|1.65||Adjusted for analysis site. Relative risk of partial clearance relative to 2-day group.|Cochran-Mantel-Haenszel||Relative risk and confidence interval were adjusted for analysis site and were Mantel-Haenszel estimators. Relative risk of partial clearance relative to vehicle group.|The treatment comparison was based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.||1.65|0.86|0.28
70921998|NCT01843374|141334320|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92||||0.4081|TWO_SIDED|95.0|0.76|1.12||P-value was estimated using the method of Klein et al. 2007 and Whitehead and Whitehead 1991, stratified by EORTC status and Line of therapy.|Log Rank|The stratification factors included EORTC status and line of therapy as recorded in IVRS/IWRS.|Tremelimumab represents the numerator and Placebo the denominator|H0: No difference between tremelimumab and placebo H1: Difference between tremelimumab and placebo||1.12|0.76|0.4081
70921999|NCT01843374|141334321|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.011||||0.926|TWO_SIDED|95.0|0.793|1.289||Estimated using the methods of Klein et al. 2007 and Whitehead and Whitehead 1991, stratified by EORTC status and line of therapy.|Log Rank||Tremelimumab is the numerator and Placebo the denominator|||1.289|0.793|0.926
70922000|NCT01843374|141334322|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81||||0.0325|TWO_SIDED|95.0|0.68|0.98||Estimated using the methods of Klein et al. 2007 and Whitehead and Whitehead 1991, stratified by EORTC status and line of therapy.|Log Rank|Stratification factors were EORTC status and Line of therapy|Tremelimumab is the numerator and placebo, the denominator|||0.98|0.68|0.0325
70922001|NCT03397108|141334330|SUPERIORITY|||||||0.89||||||The a priori threshold of significance was set at 0.05. Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk TNF levels at EARLY LACTATION PERIOD were compared between non-IBD control and women with IBD. Our hypothesis was that women with IBD have higher TNF in milk due to the underlying inflammatory condition (IBD).||||0.89
70922002|NCT03397108|141334330|SUPERIORITY|||||||0.024|||||||Kruskal-Wallis|||"Milk TNF at the EARLY LACTATION PERIOD was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. We hypothesized that the use of TNFmAb decreases milk TNF. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.024
70922003|NCT03397108|141334330|SUPERIORITY|||||||0.7||||||The a priori threshold of significance was set at 0.05. Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk MCP1 levels (TNF dependent chemokine) at the EARLY LACTATION PERIOD were compared between non-IBD control and IBD group to see if there is a difference.||||0.70
70975557|NCT00428597|141458873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6672||||0.6487|TWO_SIDED|95.0|-8.9|5.5||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||5.5|-8.9|0.6487
71034021|NCT02354339|141577709|SUPERIORITY|||||||0.807||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of insulin sensitivity on placebo group||||0.807
71034022|NCT02354339|141577710|SUPERIORITY|||||||0.604||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of body weight on Irvingia gabonensis group||||0.604
71034023|NCT02354339|141577710|SUPERIORITY|||||||0.35||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of body weight on placebo group||||0.350
71034024|NCT02354339|141577711|SUPERIORITY|||||||0.727||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of BMI on Irvingia gabonensis group||||0.727
71034025|NCT02354339|141577711|SUPERIORITY|||||||0.229||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of BMI on placebo group||||0.229
71034026|NCT02354339|141577712|SUPERIORITY|||||||0.151||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total cholesterol on Irvingia gabonensis group||||0.151
70975558|NCT00428597|141458874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.88||||0.6545|TWO_SIDED|95.0|-6.4|10.1||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||10.1|-6.4|0.6545
71034027|NCT02354339|141577712|SUPERIORITY|||||||0.955||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total cholesterol on placebo group||||0.955
71034028|NCT02354339|141577713|SUPERIORITY|||||||0.35||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of LDL-c on Irvingia gabonensis group||||0.350
70922004|NCT03397108|141334330|SUPERIORITY|||||||0.93||||||Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk levels of MIP-1 beta (TNF dependent chemokine) at the EARLY LACTATION PERIOD were compared between non-IBD control and IBD group to see if there is a difference.||||0.93
70922005|NCT03397108|141334330|SUPERIORITY|||||||0.12||||||The a priori threshold of significance was set at 0.05. Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk IP10 levels (one of the TNF dependent chemokines) at EARLY LACTATION PERIOD were compared between non-IBD control and IBD group to see if there is a difference.||||0.12
70922006|NCT03397108|141334330|SUPERIORITY|||||||0.12|||||||Kruskal-Wallis|||Milk levels of TNF-dependent chemokine, MCP1, at the EARLY LACTATION PERIOD was compared among the 3 groups: non-IBD control and the 2 IBD subgroups. We hypothesized that the use of TNFmAb decreases milk TNF and TNF-dependent chemokine including MCP1. Nonparametric comparison of the 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test.||||0.12
71034029|NCT02354339|141577713|SUPERIORITY|||||||0.47||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of LDL-c on placebo group||||0.470
70922007|NCT03397108|141334330|SUPERIORITY|||||||0.051|||||||Kruskal-Wallis|||"Milk MIP-1beta at the EARLY LACTATION PERIOD was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. We hypothesized that the use of TNFmAb decreases milk TNF and TNF-dependent chemokine including MIP-1beta. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.051
70922008|NCT03397108|141334330|SUPERIORITY|||||||0.0046|||||||Kruskal-Wallis|||"Milk IP10 at the EARLY LACTATION PERIOD was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. We hypothesized that the use of TNFmAb decreases milk TNF and TNF-dependent chemokine including IP10. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.0046
70922009|NCT03397108|141334330|SUPERIORITY|||||||0.35||||||Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Comparison of milk TNF level at the MID LACTATION POINT between non-IBD control and IBD group. The same analytical framework as the early lactation, but this is based on data at the mid-lactation point (13-14 postpartum weeks). Our hypothesis is the same as for the early-lactation point.||||0.35
71034030|NCT02354339|141577714|SUPERIORITY|||||||0.91||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of AST on Irvingia gabonensis group||||0.910
71034031|NCT02354339|141577714|SUPERIORITY|||||||0.436||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of AST on placebo group||||0.436
70975559|NCT00428597|141458875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0035||||0.1936|TWO_SIDED|95.0|-10.0|2.0||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||2|-10|0.1936
71034032|NCT02354339|141577715|SUPERIORITY|||||||0.989||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of ALT on Irvingia gabonensis group||||0.989
70975560|NCT00428597|141458876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.3801|||<|0.0001|TWO_SIDED|95.0|14.3|28.4||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||28.4|14.3|<0.0001
70975561|NCT00428597|141458877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.23||||0.1339|TWO_SIDED|95.0|-1.6|12.1||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||12.1|-1.6|0.1339
70975562|NCT00428597|141458878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7816||||0.6138|TWO_SIDED|95.0|-5.1|8.7||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||8.7|-5.1|0.6138
70975563|NCT00428597|141458879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2778||||0.9367|TWO_SIDED|95.0|-6.6|7.1||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||7.1|-6.6|0.9367
70975564|NCT00428597|141458880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.753||||0.0372|TWO_SIDED|95.0|0.5|15.0||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||15|0.5|0.0372
70975565|NCT00428597|141458881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1463||||0.6939|TWO_SIDED|95.0|-4.6|6.9||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||6.9|-4.6|0.6939
70975566|NCT00428597|141458882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5128||||0.3711|TWO_SIDED|95.0|-11.2|4.2||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||4.2|-11.2|0.3711
70975567|NCT01469000|141458883|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.67||||0.009|TWO_SIDED|95.0|0.48|0.93||1-sided.|Regression, Cox|Adjusted for gender, performance status, previous adjuvant /neoadjuvant treatment, age, smoking history, mutation type, and country.||||0.93|0.48|0.009
70975568|NCT01469000|141458884|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.64||||0.005|TWO_SIDED|95.0|0.46|0.9||1 sided.|Regression, Cox|Adjusted for gender, performance status, previous adjuvant /neoadjuvant treatment, age, smoking history, mutation type, and country.||||0.90|0.46|0.005
70975569|NCT01469000|141458885|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.105|TWO_SIDED|95.0|0.51|1.16||1 sided.|Regression, Cox|Adjusted for gender, performance status, previous adjuvant /neoadjuvant treatment, age, smoking history, mutation type, and country.||||1.16|0.51|0.105
70975570|NCT01469000|141458889|SUPERIORITY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.77|1.78||||||Patient-rated Loss of Appetite: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.78|0.77|
70975571|NCT01469000|141458889|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.6|1.42||||||Patient-rated Fatigue: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.42|0.60|
71034033|NCT02354339|141577715|SUPERIORITY|||||||0.949||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of ALT on placebo group||||0.949
70975572|NCT01469000|141458889|SUPERIORITY||Hazard Ratio (HR)|1.39|||||TWO_SIDED|95.0|0.84|2.3||||||Patient-rated Cough: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||2.30|0.84|
70975573|NCT01469000|141458889|SUPERIORITY||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.65|1.71||||||Patient-rated Dyspnea: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.71|0.65|
70975574|NCT01469000|141458889|SUPERIORITY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.32|1.02||||||Patient-rated Hemoptysis: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.02|0.32|
70975575|NCT01469000|141458889|SUPERIORITY||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.64|1.91||||||Patient-rated Pain: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.91|0.64|
70975576|NCT01469000|141458889|SUPERIORITY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.68|1.77||||||Patient-rated Overall Symptoms: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.77|0.68|
70975577|NCT01469000|141458889|SUPERIORITY||Hazard Ratio (HR)|1.38|||||TWO_SIDED|95.0|0.88|2.17||||||Patient-rated Interference: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||2.17|0.88|
70975578|NCT01469000|141458889|SUPERIORITY||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.72|1.74||||||Patient-rated Quality of Life: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.74|0.72|
70975579|NCT01469000|141458889|SUPERIORITY||Hazard Ratio (HR)|1.56|||||TWO_SIDED|95.0|0.97|2.49||||||Observer-rated Loss of Appetite: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)||2.49|0.97|
70975580|NCT01469000|141458889|SUPERIORITY||Hazard Ratio (HR)|1.26|||||TWO_SIDED|95.0|0.82|1.93||||||Observer-rated Fatigue: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)||1.93|0.82|
70975581|NCT01469000|141458889|SUPERIORITY||Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|0.72|2.15||||||Observer-rated Cough:Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)||2.15|0.72|
70975582|NCT01469000|141458889|SUPERIORITY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.64|1.83||||||Observer-rated Dyspnea: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)||1.83|0.64|
70975583|NCT01469000|141458889|SUPERIORITY||Hazard Ratio (HR)|1.32|||||TWO_SIDED|95.0|0.6|2.91||||||Observer-rated Hemoptysis: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)||2.91|0.60|
70975584|NCT01469000|141458889|SUPERIORITY||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.41|1.03||||||Observer-rated Pain: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)||1.03|0.41|
70975585|NCT00632853|141458893|SUPERIORITY|||||||0.8741|||||||Log Rank|||||||0.8741
70975586|NCT00654498|141458936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.52|STANDARD_ERROR_OF_MEAN|1.05|<|0.0001|TWO_SIDED|95.0|-6.58|-2.46|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||-2.46|-6.58|<0.0001
70975587|NCT00654498|141458937|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|test stratified by centre||||||<0.0001
70975588|NCT00654498|141458938|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|test stratified by centre||||||<0.0001
70975589|NCT00654498|141458939|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|test stratified by centre||||||<0.0001
70975590|NCT00654498|141458940|SUPERIORITY_OR_OTHER|||||||0.1386||95.0|||||Chi-squared|||||||0.1386
70975591|NCT00654498|141458941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.48|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-2.14|-0.83|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||-0.83|-2.14|<0.0001
70975592|NCT00654498|141458942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-1.99|-0.73|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||-0.73|-1.99|<0.0001
70975593|NCT00654498|141458943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-2.0|-0.72|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||-0.72|-2.00|<0.0001
70975594|NCT00654498|141458944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.26||0.0402|TWO_SIDED|95.0|-1.06|-0.02|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||-0.02|-1.06|0.0402
70975595|NCT00654498|141458945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.18||0.0771|TWO_SIDED|95.0|-0.69|0.04|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||0.04|-0.69|0.0771
70975596|NCT00654498|141458946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.25||0.0048|TWO_SIDED|95.0|-1.2|-0.22|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||-0.22|-1.20|0.0048
70975597|NCT00654498|141458947|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||||<0.0001
70975598|NCT02065453|141458968|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The data will be analyzed using linear regression, Kolmogorov-Smirnov test, and chi-square analysis.||||<0.001
70975599|NCT01916980|141458973|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Longitudinal Data Analysis|Model includes terms of visit, group and visit by group interaction; visit is treated as a categorical variable||Analysis of the change from Baseline in least squares (LS) mean for the Desloratadine: Eczema/Dermatitis group||||<0.001
70975600|NCT01916980|141458973|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Longitudinal Data Analysis|Model includes terms of visit, group and visit by group interaction; visit is treated as a categorical variable||Analysis of the change from Baseline in LS mean for the Desloratadine: Dermal Pruritus group||||<0.001
70975601|NCT02324270|141458982|EQUIVALENCE|If the 90% CI for the ratio of mean changes between test and reference products was contained within the interval, \[0.80,1.25\], then the products were considered to be equivalent.|Ratio|1.01|||||TWO_SIDED|90.0|0.94|1.08||||||||1.08|0.94|
70975602|NCT02324270|141458983|SUPERIORITY|||||||0.01|||||||ANCOVA|||||||0.01
70975603|NCT02324270|141458983|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
70975604|NCT03521791|141458984|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.133|||||||Chi-squared, Corrected|||||||0.133
70975605|NCT03521791|141458985|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.045|||||||Wilcoxon (Mann-Whitney)|||||||0.045
70975606|NCT03521791|141458986|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.333|||||||Chi-squared, Corrected|||||||0.333
70975607|NCT03521791|141458987|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.058|||||||Wilcoxon (Mann-Whitney)|||||||0.058
70975608|NCT03521791|141458988|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.394|||||||Fisher Exact|||||||0.394
70975609|NCT03521791|141458989|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.056|||||||t-test, 2 sided|||||||0.056
70975610|NCT03521791|141458991|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.114|||||||Fisher Exact|||||||0.114
70975611|NCT03521791|141458992|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.117|||||||Chi-squared, Corrected|||||||0.117
70975612|NCT03521791|141458993|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.626|||||||Fisher Exact|||||||0.626
70975613|NCT04024501|141458994|OTHER||Geometric Mean ratio|106.2|||||TWO_SIDED|90.0|91.73|122.96|||Mixed Model Analysis|The number of subjects in this analysis: 22||Pairwise comparison: Treatment 2/Treatment 1||122.96|91.73|
70975614|NCT04024501|141458994|OTHER||Geometric mean ratio|50.02|||||TWO_SIDED|90.0|42.34|59.1|||Mixed Model Analysis|The number of subjects in this analysis: 22||Pairwise comparison: Treatment 3/Treatment 1||59.10|42.34|
70975615|NCT04024501|141458994|OTHER||Geometric mean ratio|47.1|||||TWO_SIDED|90.0|39.85|55.68|||Mixed Model Analysis|The number of subjects in this analysis: 15||Pairwise comparison: Treatment 3/Treatment 2||55.68|39.85|
70975616|NCT04024501|141458994|OTHER||Geometric mean ratio|58.4|||||TWO_SIDED|90.0|49.49|68.92|||Mixed Model Analysis|The number of subjects in this analysis: 15||Pairwise comparison: Treatment 3/Treatment 4||68.92|49.49|
70975617|NCT04024501|141458994|OTHER||Geometric mean ratio|85.65|||||TWO_SIDED|90.0|73.78|99.43|||Mixed Model Analysis|The number of subjects in this analysis: 21||Pairwise comparison: Treatment 4/Treatment 1||99.43|73.78|
70975618|NCT04024501|141458994|OTHER||Geometric mean ratio|80.65|||||TWO_SIDED|90.0|69.48|93.62|||Mixed Model Analysis|The number of subjects in this analysis: 21||Pairwise comparison: Treatment 4/Treatment 2||93.62|69.48|
70975619|NCT04024501|141458994|OTHER||Geometric mean ratio|89.88|||||TWO_SIDED|90.0|77.61|104.09|||Mixed Model Analysis|The number of subjects in this analysis: 21||Pairwise comparison: Treatment 5/Treatment 1||104.09|77.61|
70975620|NCT04024501|141458994|OTHER||Geometric mean ratio|84.64|||||TWO_SIDED|90.0|72.94|98.2|||Mixed Model Analysis|The number of subjects in this analysis: 21||Pairwise comparison: Treatment 5/Treatment 2||98.20|72.94|
70975621|NCT04024501|141458994|OTHER||Geometric mean ratio|179.68|||||TWO_SIDED|90.0|151.57|212.99|||Mixed Model Analysis|The number of subjects in this analysis: 21||Pairwise comparison: Treatment 5/Treatment 3||212.99|151.57|
70975622|NCT04024501|141458994|OTHER||Geometric mean ratio|104.94|||||TWO_SIDED|90.0|90.18|122.11|||Mixed Model Analysis|The number of subjects in this analysis: 21||Pairwise comparison: Treatment 5/Treatment 4||122.11|90.18|
70975623|NCT04024501|141458995|OTHER||Geometric mean ratio|100.39|||||TWO_SIDED|90.0|84.94|118.65|||Mixed Model Analysis|The number of subjects in this analysis: 25||Pairwise comparison: Treatment 2/Treatment 1||118.65|84.94|
71034034|NCT02354339|141577716|SUPERIORITY|||||||0.095||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of creatinine on Irvingia gabonensis group||||0.095
70975624|NCT04024501|141458995|OTHER||Geometric mean ratio|41.26|||||TWO_SIDED|90.0|34.74|49.0|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 3/Treatment 1||49.00|34.74|
70975625|NCT04024501|141458995|OTHER||Geometric mean ratio|41.1|||||TWO_SIDED|90.0|34.61|48.81|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 3/Treatment 2||48.81|34.61|
71034035|NCT02354339|141577716|SUPERIORITY|||||||0.401||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of creatinine on placebo group||||0.401
71034036|NCT02354339|141577717|SUPERIORITY|||||||0.91||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of uric acid on Irvingia gabonensis group||||0.910
71034037|NCT02354339|141577717|SUPERIORITY|||||||0.791||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of uric acid on placebo group||||0.791
71034038|NCT01848938|141577731|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Linear Mixed Models analysis|||analysis between groups||||<0.001
71034039|NCT01848938|141577732|SUPERIORITY_OR_OTHER|||||||0.005|||||||Linear Mixed Models analysis|||analysis between groups||||0.005
71034040|NCT01848938|141577733|SUPERIORITY_OR_OTHER|||||||0.023|||||||Wilcoxon (Mann-Whitney)|||analysis between groups||||0.023
71034041|NCT01848938|141577735|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||analysis between groups||||0.001
71034042|NCT01848938|141577736|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||analysis between groups||||<0.001
71034043|NCT00099047|141577752|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.05|STANDARD_DEVIATION|0.05||0.23|TWO_SIDED||||||SAS version 8||36 evaluable patients randomized 1:1 to each treatment was planned in order to have \>77% power to detect differences in above parameters equal to or greater than one standard deviation, based on a 2-sided Wilcoxon rank-sum test with .05 Type I error.|||||.23
71034044|NCT00651820|141577753|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Paired-Prentice Wilcoxon (PPW)|Time to complete wound closure Drug(T1)and Vehicle(T2)Hypothesis, Ho: T1=T2,using paired Prentice-Wilcoxon at significant level of 5%, 2-sided.||Each subject served as their own control, each receiving duplicate dermatome-induced wounds with 1 wound treated with active drug and the other treated with vehicle. Mean time to wound closure was calculated for the wounds treated with drug, the wounds treated with vehicle, and an over-all mean time to wound closure||||<0.05
71034045|NCT00651820|141577754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.2|||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Stiffness: Paired t-test and Wilcoxon signed rank test were used for testing any significant differences (Sig. diff.) between the two treatments||||<0.05
70975626|NCT04024501|141458995|OTHER||Geometric mean ratio|53.55|||||TWO_SIDED|90.0|45.09|63.59|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 3/Treatment 4||63.59|45.09|
71034046|NCT00651820|141577754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.88|||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Energy Absorption: Paired t-test and Wilcoxon signed rank test were used for testing any significant differences (Sig. diff.) between the two treatments||||<0.05
70975627|NCT04024501|141458995|OTHER||Geometric mean ratio|77.05|||||TWO_SIDED|90.0|65.19|91.06|||Mixed Model Analysis|The number of subjects in this analysis: 25||Pairwise comparison: Treatment 4/Treatment 1||91.06|65.19|
70975628|NCT04024501|141458995|OTHER||Geometric mean ratio|76.75|||||TWO_SIDED|90.0|64.94|90.71|||Mixed Model Analysis|The number of subjects in this analysis: 25||Pairwise comparison: Treatment 4/Treatment 2||90.71|64.94|
71034047|NCT01302548|141577757|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0833|STANDARD_DEVIATION|0.8609||0.797|TWO_SIDED|95.0|-0.5738|0.7405||This is unadjusted.|t-test, 2 sided|Degrees of freedom = 28||"Ho: There is not a significant difference between the use of IRRISEPT solution and the usual care methods on abscess healing.~This study did not enroll an adequate number of patients to meet sufficient power."||.7405|-.5738|.7970
71034048|NCT01302548|141577758|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.2364||||0.3575|TWO_SIDED|95.0|0.0239|2.3394||This is unadjusted.|Fisher Exact|Cell (1,1) Frequency (F) = 13||"Ho: There is not a significant difference between the proportion of patients requiring antibiotics after the use of IRRISEPT solution vs. the usual care methods on abscess healing.~This study did not enroll an adequate number of patients to meet sufficient power."||2.3394|.0239|.3575
71034049|NCT01302548|141577759|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.5477||0.5415|TWO_SIDED|95.0|-2.0659|1.2659||This is unadjusted.|t-test, 2 sided|Degrees of freedom = 4||"Ho: There is not a significant difference between the use of IRRISEPT solution and the usual care methods on abscess healing in patients that are MRSA positive.~This study did not enroll an adequate number of patients to meet sufficient power."||1.2659|-2.0659|.5415
71034050|NCT00950989|141577760|SUPERIORITY||Difference in response rate|3.2||||0.598|TWO_SIDED|95.0|-9.0|15.4||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||15.4|-9.0|0.598
70975629|NCT04024501|141458995|OTHER||Geometric mean ratio|84.23|||||TWO_SIDED|90.0|70.93|100.03|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 1||100.03|70.93|
71034051|NCT00950989|141577760|SUPERIORITY|||||||0.993||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.993
71034052|NCT00950989|141577760|SUPERIORITY||Difference in response rate|3.2||||0.635|TWO_SIDED|95.0|-9.0|15.4||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||15.4|-9.0|0.635
71034053|NCT00950989|141577760|SUPERIORITY|||||||0.74||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.740
71034054|NCT00950989|141577760|SUPERIORITY||Difference in response rate|-3.2||||0.572|TWO_SIDED|95.0|-14.1|7.8||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||7.8|-14.1|0.572
71034055|NCT00950989|141577760|SUPERIORITY|||||||0.572||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.572
71034056|NCT00950989|141577761|SUPERIORITY||Difference in response rates|-3.2||||0.728|TWO_SIDED|95.0|-20.4|14.0||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||14.0|-20.4|0.728
71034057|NCT00950989|141577761|SUPERIORITY|||||||0.993||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.993
71034058|NCT00950989|141577761|SUPERIORITY||Difference in response rates|-6.3||||0.412|TWO_SIDED|95.0|-23.4|10.7||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||10.7|-23.4|0.412
71034059|NCT00950989|141577761|SUPERIORITY|||||||0.74||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedures|||||||0.740
71034060|NCT00950989|141577761|SUPERIORITY||Difference in response rates|3.2||||0.74|TWO_SIDED|95.0|-14.2|20.5||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||20.5|-14.2|0.740
71034061|NCT00950989|141577761|SUPERIORITY|||||||0.993||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.993
71034062|NCT00950989|141577762|SUPERIORITY||Difference in response rates|0.0||||0.984|TWO_SIDED|95.0|-6.1|6.1||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||6.1|-6.1|0.984
71034063|NCT00950989|141577762|SUPERIORITY|||||||0.993||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.993
71034064|NCT00950989|141577762|SUPERIORITY||Difference in response rates|0.0||||0.993|TWO_SIDED|95.0|-6.1|6.1||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||6.1|-6.1|0.993
71034065|NCT00950989|141577762|SUPERIORITY|||||||0.993||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.993
71034066|NCT00950989|141577762|SUPERIORITY||Difference in response rates|-3.2||||0.159|TWO_SIDED|95.0|-7.5|1.2||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||1.2|-7.5|0.159
71034067|NCT00950989|141577762|SUPERIORITY|||||||0.797||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.797
71034068|NCT00950989|141577763|SUPERIORITY||LS Mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.459|TWO_SIDED|95.0|-0.7|0.3||P-value is nominal without multiplicity adjustment based on ANCOVA model adjusting for sex and baseline DAS28 score.|ANCOVA|||||0.3|-0.7|0.459
71034069|NCT00950989|141577763|SUPERIORITY||LS mean of difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.906|TWO_SIDED|95.0|-0.5|0.5||P-value is nominal without multiplicity adjustment based on ANCOVA model adjusting for sex and baseline DAS28 score.|ANCOVA|||||0.5|-0.5|0.906
71034070|NCT00950989|141577763|SUPERIORITY||LS mean of difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.849|TWO_SIDED|95.0|-0.5|0.5||P-value is nominal without multiplicity adjustment based on ANCOVA model adjusting for sex and baseline DAS28 score.|ANCOVA|||||0.5|-0.5|0.849
71034071|NCT03527485|141577768|EQUIVALENCE|Between-group comparisons of binding potential non displaceable (BPND) in ventral striatum (VS).||||||0.011|||||||ANOVA|||||||0.011
71034072|NCT03527485|141577768|EQUIVALENCE|Between-group comparisons of binding potential non displaceable (BPND) in Prefrontal cortex (PFC).||||||0.044|||||||ANOVA|||||||0.044
71034073|NCT00730691|141577769|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.843||0.255|TWO_SIDED|95.0|-2.62|0.69||This treatment arm is not in the pre-specified testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||P-values were tested at the 5% level of significance (ie, statistical significance if P\<0.05) comparing each of the 3 doses of vortioxetine to placebo.||0.69|-2.62|0.255
71034074|NCT00730691|141577769|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.843||0.719|TWO_SIDED|95.0|-1.96|1.35||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.025, the testing procedure stopped for all subsequent endpoints.||1.35|-1.96|0.719
71034075|NCT00730691|141577769|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.848||0.642|TWO_SIDED|95.0|-2.06|1.27||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.025, the testing procedure stopped for all subsequent endpoints.||1.27|-2.06|0.642
71034076|NCT00730691|141577769|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.869||0.003|TWO_SIDED|95.0|-4.3|-0.89|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||-0.89|-4.30|0.003
70975630|NCT04024501|141458995|OTHER||Geometric mean ratio|83.9|||||TWO_SIDED|90.0|70.65|99.64|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 2||99.64|70.65|
70975631|NCT04024501|141458995|OTHER||Geometric mean ratio|204.16|||||TWO_SIDED|90.0|171.22|243.42|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 3||243.42|171.22|
70975632|NCT04024501|141458995|OTHER||Geometric mean ratio|109.32|||||TWO_SIDED|90.0|92.06|129.83|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 4||129.83|92.06|
70975633|NCT04024501|141458996|OTHER||Geometric mean ratio|124.99|||||TWO_SIDED|90.0|101.09|154.54|||Mixed Model Analysis|The number of subjects in this analysis: 25||Pairwise comparison: Treatment 2/Treatment 1||154.54|101.09|
71034077|NCT00730691|141577770|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.511||0.83|TWO_SIDED|95.0|-0.89|1.11|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||1.11|-0.89|0.830
71034078|NCT00730691|141577770|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.51||0.643|TWO_SIDED|95.0|-1.24|0.77||Hierarchical testing stopped at the primary endpoint in the testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.77|-1.24|0.643
71034079|NCT00730691|141577770|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.09|STANDARD_ERROR_OF_MEAN|0.517||0.036|TWO_SIDED|95.0|-2.1|-0.07||Hierarchical testing stopped at the primary endpoint in the testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||-0.07|-2.10|0.036
71034080|NCT00730691|141577770|SUPERIORITY_OR_OTHER||LS mean Difference|-1.54|STANDARD_ERROR_OF_MEAN|0.527||0.004|TWO_SIDED|95.0|-2.58|-0.5|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||-0.50|-2.58|0.004
71034081|NCT00730691|141577771|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.129||0.407|TWO_SIDED|95.0|-0.36|0.15|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.15|-0.36|0.407
71034082|NCT00730691|141577771|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.129||0.533|TWO_SIDED|95.0|-0.33|0.17|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.17|-0.33|0.533
71034083|NCT00730691|141577771|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.13||0.491|TWO_SIDED|95.0|-0.34|0.17|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.17|-0.34|0.491
71034084|NCT00730691|141577771|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.133||0.001|TWO_SIDED|95.0|-0.7|-0.17|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||-0.17|-0.70|0.001
71034085|NCT00730691|141577772|SUPERIORITY_OR_OTHER||LS Mean Difference|0.35|STANDARD_ERROR_OF_MEAN|0.765||0.652|TWO_SIDED|95.0|-1.16|1.85|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||1.85|-1.16|0.652
71034086|NCT00730691|141577772|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.754||0.511|TWO_SIDED|95.0|-1.98|0.98|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.98|-1.98|0.511
70975634|NCT04024501|141458996|OTHER||Geometric mean ratio|33.77|||||TWO_SIDED|90.0|27.15|42.01|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 3/Treatment 1||42.01|27.15|
70975635|NCT04024501|141458996|OTHER||Geometric mean ratio|27.02|||||TWO_SIDED|90.0|21.72|33.61|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 3/Treatment 2||33.61|21.72|
70975636|NCT04024501|141458996|OTHER||Geometric mean ratio|36.84|||||TWO_SIDED|90.0|29.61|45.82|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 3/Treatment 4||45.82|29.61|
70975637|NCT04024501|141458996|OTHER||Geometric mean ratio|91.69|||||TWO_SIDED|90.0|74.15|113.36|||Mixed Model Analysis|The number of subjects in this analysis: 25||Pairwise comparison: Treatment 4/Treatment 1||113.36|74.15|
70975638|NCT04024501|141458996|OTHER||Geometric mean ratio|73.36|||||TWO_SIDED|90.0|59.33|90.7|||Mixed Model Analysis|The number of subjects in this analysis: 25||Pairwise comparison: Treatment 4/Treatment 2||90.70|59.33|
70975639|NCT04024501|141458996|OTHER||Geometric mean ratio|67.62|||||TWO_SIDED|90.0|54.37|84.12|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 1||84.12|54.37|
71034087|NCT00730691|141577772|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.736||0.204|TWO_SIDED|95.0|-2.38|0.51|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.51|-2.38|0.204
71034088|NCT00730691|141577772|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.57|STANDARD_ERROR_OF_MEAN|0.781||0.001|TWO_SIDED|95.0|-4.1|-1.03|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||-1.03|-4.10|0.001
71034089|NCT00730691|141577773|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.114||||0.641|TWO_SIDED|95.0|0.709|1.75|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.||||1.750|0.709|0.641
71034090|NCT00730691|141577773|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.016||||0.945|TWO_SIDED|95.0|0.643|1.605|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.||||1.605|0.643|0.945
71034091|NCT00730691|141577773|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.114||||0.641|TWO_SIDED|95.0|0.709|1.749|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.||||1.749|0.709|0.641
71034092|NCT00730691|141577773|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.427||||0.124|TWO_SIDED|95.0|0.907|2.246|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.||||2.246|0.907|0.124
71034093|NCT00730691|141577774|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|1.346||0.064|TWO_SIDED|95.0|-5.15|0.14|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.14|-5.15|0.064
71034094|NCT00730691|141577774|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.26|STANDARD_ERROR_OF_MEAN|1.353||0.096|TWO_SIDED|95.0|-4.92|0.4|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.40|-4.92|0.096
71034095|NCT00730691|141577774|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.61|STANDARD_ERROR_OF_MEAN|1.397||0.25|TWO_SIDED|95.0|-4.36|1.14|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||1.14|-4.36|0.250
71034096|NCT00730691|141577774|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.54|STANDARD_ERROR_OF_MEAN|1.425||0.002|TWO_SIDED|95.0|-7.34|-1.73|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||-1.73|-7.34|0.002
70922010|NCT03397108|141334330|SUPERIORITY|||||||0.11|||||||Kruskal-Wallis|||"Milk TNF at MID LACTATION POINT was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. Hypothesis is the same as for the early lactation point. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.11
70922011|NCT03397108|141334330|SUPERIORITY|||||||0.26||||||Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk MCP1 level comparison between non-IBD control and IBD group at the MID LACTATION POINT(13-14 postpartum weeks). Our hypothesis is the same as for the early-lactation point.||||0.26
70922012|NCT03397108|141334330|SUPERIORITY|||||||0.15||||||Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk MIP-1beta level comparison between non-IBD control and IBD group at the MID LACTATION POINT (13-14 postpartum weeks). Our hypothesis is the same as for the early-lactation point.||||0.15
70922013|NCT03397108|141334330|SUPERIORITY|||||||0.31||||||Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk IP10 level comparison between non-IBD control and IBD group at the MID LACTATION POINT (13-14 postpartum weeks). Our hypothesis is the same as for the early-lactation point.||||0.31
70922014|NCT03397108|141334330|SUPERIORITY|||||||0.21|||||||Kruskal-Wallis|||"Milk MCP-1 at the MID LACTATION PERIOD was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. The hypothesis is the same as that for the early-lactation period. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.21
70922015|NCT03397108|141334330|SUPERIORITY|||||||0.12|||||||Kruskal-Wallis|||"Milk MIP-1beta at the MID LACTATION POINT was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. The hypothesis is the same as that for the early-lactation period. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.12
70922016|NCT03397108|141334330|SUPERIORITY|||||||0.29|||||||Kruskal-Wallis|||"Milk IP10 at the MID LACTATION POINT was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. The same hypothesis as that for the early-lactation period. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.29
70922017|NCT03397108|141334330|OTHER|Correlation analysis|Spearman rank correlation|0.7232|||<|0.0001|TWO_SIDED|95.0|0.5647|0.8303||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants at the EARLY LACTATION, we analyzed correlation between milk TNF and chemokine MCP1 to see if they are positively correlated. This is to show supportive evidence for TNF dependency of chemokine MCP1.||0.8303|0.5647|<0.0001
70922018|NCT03397108|141334330|OTHER|Correlation analysis|Spearman rank correlation|0.6835|||<|0.0001|TWO_SIDED|95.0|0.5088|0.8042||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants at the EARLY LACTATION, we analyzed correlation between milk TNF and chemokine MIP-1beta to see if they are positively correlated. This is to show supportive evidence for TNF dependency of chemokine MIP-1beta.||0.8042|0.5088|<0.0001
70922019|NCT03397108|141334330|OTHER|Correlation analysis|Spearman rank correlation|0.6316|||<|0.0001|TWO_SIDED|95.0|0.4377|0.7693||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants at the EARLY LACTATION, we analyzed correlation between milk TNF and chemokine IP10 to see if they are positively correlated. This is to show supportive evidence for TNF dependency of chemokine IP10.||0.7693|0.4377|<0.0001
70922020|NCT03397108|141334330|OTHER|Correlation analysis|Spearman rank correlation|0.572|||<|0.0001|TWO_SIDED|95.0|0.3445|0.736||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants at the MID LACTATION POINT, we analyzed correlation between milk TNF and MCP1 to see of they are positively correlated.||0.7360|0.3445|<0.0001
70922021|NCT03397108|141334330|OTHER|Correlation analysis|Spearman rank correlation|0.7564|||<|0.0001|TWO_SIDED|95.0|0.6022|0.8562||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants at the MID LACTATION POINT, we analyzed correlation between milk TNF and MIP-1beta to see of they are positively correlated.||0.8562|0.6022|<0.0001
70922022|NCT03397108|141334330|OTHER|Correlation analysis|Spearman rank correlation|0.32||||0.0227|TWO_SIDED|95.0|0.03869|0.552||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants at the MID LACTATION POINT, we analyzed correlation between milk TNF and IP10 to see of they are positively correlated.||0.5520|0.03869|0.0227
70922023|NCT03397108|141334330|OTHER|Correlation analysis|Spearman rank correlation|0.52||||0.0001|TWO_SIDED|95.0|0.2727|0.6975||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants, we assessed temporal tracking of milk TNF between early and mid-lactation points.||0.6975|0.2727|0.0001
70922024|NCT03397108|141334330|OTHER|Correlation analysis|Spearman rank correlation|0.4722||||0.0005|TWO_SIDED|95.0|0.2181|0.6664||Not adjusted for multiple comparison.|Spearman rank correlation|||Using the pooled data of all participants, we assessed temporal tracking of milk MCP1 between early and mid-lactation points.||0.6664|0.2181|0.0005
70922025|NCT03397108|141334330|OTHER|Correlation analysis|Spearman rank correlation|0.36||||0.01|TWO_SIDED|95.0|0.0802|0.5803||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants, we assessed temporal tracking of milk MIP-1beta between early and mid-lactation points.||0.5803|0.0802|0.01
70922026|NCT03397108|141334330|OTHER|Correlation analysis|Spearman rank correlation|0.66|||<|0.0001|TWO_SIDED|95.0|0.467|0.7964||Not adjusted for multiple comparison|Spearman rank correlation|Spearman r = 0.66 (95%CI: 0.4670 - 0.7964). Number of XY pairs: 51||Using the pooled data of all participants, we assessed temporal tracking of milk IP10 between early and mid-lactation points.||0.7964|0.4670|<0.0001
70922027|NCT03397108|141334331|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||Cognitive development at 12 months of age. Animal data suggested that pups receiving milk with lower TNF and TNF-dependent chemokines showed enhanced cognitive development. Because there was no guiding information in humans regarding milk TNF level differences between women with and without IBD, our main goal was to measure milk TNF levels. The infant cognitive/language assessment, therefore, had to be designed as a pilot and exploratory in nature.||||0.12
70922028|NCT03397108|141334331|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||Language development at 12 months of age.||||0.56
70922029|NCT03397108|141334331|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||Cognitive development at 18 months of age.||||0.16
70975640|NCT04024501|141458996|OTHER||Geometric mean ratio|54.11|||||TWO_SIDED|90.0|43.5|67.3|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 2||67.30|43.50|
70975641|NCT04024501|141458996|OTHER||Geometric mean ratio|200.23|||||TWO_SIDED|90.0|160.15|250.32|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 3||250.32|160.15|
70975642|NCT04024501|141458996|OTHER||Geometric mean ratio|73.76|||||TWO_SIDED|90.0|59.3|91.75|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 4||91.75|59.30|
70975643|NCT00680836|141459006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.26|TWO_SIDED|95.0|-1.0|0.3|||t-test, 2 sided|||||0.3|-1.0|0.26
70975644|NCT00680836|141459007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.98|TWO_SIDED|95.0|0.0|0.5|||t-test, 2 sided|||||0.5|0.0|0.98
70975645|NCT00680836|141459008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.78|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.78
70975646|NCT00680836|141459009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.64|TWO_SIDED|95.0|-0.2|0.2|||Chi-squared|||||0.2|-0.2|0.64
70975647|NCT00680836|141459010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.72|TWO_SIDED|95.0|-0.7|0.5|||t-test, 2 sided|||||0.5|-0.7|0.72
70975648|NCT00680836|141459011|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.86|TWO_SIDED|95.0|-0.5|0.6|||t-test, 2 sided|||||0.6|-0.5|0.86
70975649|NCT00925600|141459045|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper bound of the 97.5% one-sided confidence interval, or equivalently upper bound of two-sided 95% confidence interval was less than the pre-specified non-inferiority bound of 10%.|Risk Difference (RD)|0.4|STANDARD_ERROR_OF_MEAN|3.4||0.0026|TWO_SIDED|95.0|-6.3|7.2|||Mantel Haenszel|||The primary endpoint was summarized with the point estimate of absolute risk difference (difference in incidence rates, denosumab minus placebo) and the corresponding 95% confidence interval using the Mantel-Haenszel method adjusting for the stratification factors: baseline LOCS III status (\< 3.0 at all sites \[P, C, and NO\] vs. ≥ 3.0 at any of these sites), age group (\< 75, ≥ 75 years), and patient-reported history of cataract (yes/no).||7.2|-6.3|0.0026
70975650|NCT00925600|141459046|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.2|STANDARD_ERROR_OF_MEAN|2.1|||TWO_SIDED|95.0|-6.4|2.0||||||The point estimate of absolute risk difference (difference in incidence rates, denosumab minus placebo) and the corresponding 95% confidence interval was constructed using the Mantel-Haenszel method adjusting for the stratification factors: baseline LOCS III status (\< 3.0 at all sites \[P, C, and NO\] vs. ≥ 3.0 at any of these sites), age group (\< 75, ≥ 75 years), and patient-reported history of cataract (yes/no).||2.0|-6.4|
70975651|NCT00925600|141459047|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-5.9|5.3||||||The point estimate of absolute risk difference (difference in incidence rates, denosumab minus placebo) and the corresponding 95% confidence interval was constructed using the Mantel-Haenszel method adjusting for the stratification factors: baseline LOCS III status (\< 3.0 at all sites \[P, C, and NO\] vs. ≥ 3.0 at any of these sites), age group (\< 75, ≥ 75 years), and patient-reported history of cataract (yes/no).||5.3|-5.9|
70975652|NCT00925600|141459048|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.2|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-7.6|3.3||||||The point estimate of absolute risk difference (difference in incidence rates, denosumab minus placebo) and the corresponding 95% confidence interval was constructed using the Mantel-Haenszel method adjusting for the stratification factors: baseline LOCS III status (\< 3.0 at all sites \[P, C, and NO\] vs. ≥ 3.0 at any of these sites), age group (\< 75, ≥ 75 years), and patient-reported history of cataract (yes/no).||3.3|-7.6|
70975653|NCT05512949|141459053|NON_INFERIORITY|The ID-dose regimen is considered non-inferior if the lower bound of the confidence interval (original scale) is no less than half that of the standard dose, giving a NI margin of 0.5 (NI= -0.301 log10 scale).|Geometric mean titer ratio (GMTR)|0.7||||0.045|TWO_SIDED|95.0|0.5|1.0||Significance can be considered if P \<0.05. Not adjusted for multiple comparisons.|t-test, 2 sided|Two-sample t-test with unequal variance, noninferiority (NI) margin of 0.5 and two-sided type I error rate of 0.05.||The selection of the noninferiority (NI) margin was based on the pivotal Phase 3 trial by Pittman et al., in 2019 comparing one dose of ACAM2000 and the now licensed 2-dose standard MVA-BN regimen, which provided an estimated relative (peak) immune response of approximately 2-times higher for MVA-BN. An NI margin of 0.5 corresponds to an immune response of the lower-dose MVA-BN at least as high as what would be expected for ACAM2000.||1.0|0.5|0.045
70975654|NCT05512949|141459053|NON_INFERIORITY|The ID-dose regimen is considered non-inferior if the lower bound of the confidence interval (original scale) is no less than half that of the standard dose, giving a NI margin of 0.5 (NI= -0.301 log10 scale).|Geometric mean titer ratio (GMTR)|0.4||||0.162|TWO_SIDED|95.0|0.3|0.6||Significance can be considered if P \<0.05. Not adjusted for multiple comparisons.|t-test, 2 sided|Two-sample t-test with unequal variance, noninferiority (NI) margin of 0.5 and two-sided type I error rate of 0.05.||The selection of the noninferiority (NI) margin was based on the pivotal Phase 3 trial by Pittman et al., in 2019 comparing one dose of ACAM2000 and the now licensed 2-dose standard MVA-BN regimen, which provided an estimated relative (peak) immune response of approximately 2-times higher for MVA-BN. An NI margin of 0.5 corresponds to an immune response of the lower-dose MVA-BN at least as high as what would be expected for ACAM2000.||0.6|0.3|0.162
70975655|NCT05512949|141459056|SUPERIORITY|||||||0.888|||||||Wilcoxon (Mann-Whitney)|||||||0.888
70975656|NCT05512949|141459056|SUPERIORITY|||||||0.708|||||||Wilcoxon (Mann-Whitney)|||||||0.708
70975657|NCT04660643|141459067|SUPERIORITY||LS Mean difference|-21.4|||<|0.001|TWO_SIDED|95.0|-22.9|-20.0|||Mixed Models Analysis|||||-20.0|-22.9|<.001
70975658|NCT04660643|141459068|SUPERIORITY||LS Mean difference|-15.9|||<|0.001|TWO_SIDED|95.0|-17.0|-14.9|||Mixed Models Analysis|||||-14.9|-17.0|<.001
70975659|NCT04660643|141459069|SUPERIORITY||LS Mean difference|-17.6|||<|0.001|TWO_SIDED|95.0|-18.8|-16.4|||Mixed Models Analysis|||||-16.4|-18.8|<.001
70975660|NCT04660643|141459070|SUPERIORITY||LS Mean difference|-12.9|||<|0.001|TWO_SIDED|95.0|-14.1|-11.7|||Mixed Models Analysis|||||-11.7|-14.1|<.001
70975661|NCT04660643|141459071|SUPERIORITY||LS Mean difference|-6.4|||<|0.001|TWO_SIDED|95.0|-6.8|-6.0|||Mixed Models Analysis|||||-6.0|-6.8|<.001
71095708|NCT02762604|141699837|SUPERIORITY||Mean Difference (Net)|6.76|STANDARD_ERROR_OF_MEAN|79.95|||TWO_SIDED|95.0|-149.94|163.47|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in flanker interference pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||163.47|-149.94|
70975662|NCT04660643|141459072|SUPERIORITY||LS Mean difference|-8.64|||<|0.001|TWO_SIDED|95.0|-10.14|-7.15|||Mixed Models Analysis|||||-7.15|-10.14|<.001
70975663|NCT04660643|141459073|SUPERIORITY||LS Mean difference|-0.33|||<|0.001|TWO_SIDED|95.0|-0.38|-0.28|||Mixed Models Analysis|||||-0.28|-0.38|<.001
70975664|NCT04660643|141459074|SUPERIORITY||LS Mean difference|-31.4|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-37.7|-24.4|||Mixed Models Analysis|||||-24.4|-37.7|<.001
71095709|NCT02762604|141699838|SUPERIORITY||Mean Difference (Net)|15.2|STANDARD_ERROR_OF_MEAN|4.7|||TWO_SIDED|95.0|5.99|24.41|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in stride length during walking while talking pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||24.41|5.99|
71095710|NCT02762604|141699839|SUPERIORITY||Mean Difference (Net)|-1.96|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-3.73|-0.2|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in gait variability during walking while talking pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||-0.20|-3.73|
70922030|NCT03397108|141334331|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||Language development at 18 months of age||||0.75
70922031|NCT03397108|141334331|OTHER|Correlation analysis|Spearman rank correlation|0.2655||||0.0853|TWO_SIDED|95.0|-0.047|0.5307|||Spearman rank correlation|||Using pooled data of all participants at the early-lactation sample point, correlation between milk TNF levels and 12 month cognitive development was examined to investigate if they were inversely correlated.||0.5307|-0.047|0.0853
70922032|NCT03397108|141334331|OTHER|Correlation analysis|Spearman rank correlation|0.3705||||0.09|TWO_SIDED|95.0|-0.07385|0.6921|||Spearman rank correlation|||Using the pooled data of all participants, correlation analysis between milk TNF at early lactation and 12 month language score was done to see if they were inversely correlated.||0.6921|-0.07385|0.090
70922033|NCT03397108|141334333|SUPERIORITY|||||||0.97||||||Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||This is to confirm that the 2 groups are not different for their sampling time points in the early lactation period.||||0.97
70922034|NCT03397108|141334333|SUPERIORITY|||||||0.96|||||||Kruskal-Wallis|||||||0.96
70922035|NCT03397108|141334334|SUPERIORITY|||||||0.56||||||No adjustment for multiple comparison.|Wilcoxon (Mann-Whitney)|||This is to confirm that there is no difference in the second sampling time points in the mid-lactation period between the groups.||||0.56
70922036|NCT03397108|141334334|SUPERIORITY|||||||0.51|||||||Kruskal-Wallis|||||||0.51
70922037|NCT02605837|141334377|SUPERIORITY||Difference in proportion of responders|0.52|||<|0.001||95.0|0.433|0.591|||Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel (CMH) adjusted difference in proportion with corresponding Newcombe confidence interval (CI) and odds ratio with corresponding CI were based on CMH test stratified by age group and diet restriction.||0.591|0.433|<0.001
70922038|NCT02605837|141334378|SUPERIORITY||Difference in proportion of responders|0.13||||0.024||95.0|0.016|0.243|||Cochran-Mantel-Haenszel|||The CMH adjusted difference in proportion with corresponding Newcombe confidence interval (CI) and odds ratio with corresponding CI were based on CMH test stratified by age group and diet restriction.||0.243|0.016|0.024
70922039|NCT02605837|141334379|SUPERIORITY||Difference in Least square mean|-3.92||||0.015||95.0|-7.073|-0.774|||ANCOVA|||This analysis was from analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline DSQ combined score as a continuous covariate.||-0.774|-7.073|0.015
70922040|NCT02605837|141334380|SUPERIORITY||Difference in Least square mean|-1.8|||<|0.001||95.0|-2.6|-1.1|||ANCOVA|||This analysis was from analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline. Total EREFS (endoscopy score) as a continuous covariate.||-1.1|-2.6|<0.001
70922041|NCT02605837|141334381|SUPERIORITY||Odds Ratio (OR)|169.74|||<|0.001||95.0|23.235|1239.979|||Regression, Logistic|||Peak eosinophil count (\<15/HPF) was performed based on logistic regression model adjusted for age group and diet restriction.||1239.979|23.235|<0.001
70922042|NCT02605837|141334381|SUPERIORITY||Odds Ratio (OR)|100.69||||0.001|TWO_SIDED|95.0|6.294|1610.749|||Firth logistic regression|||Peak eosinophil count (\<=1/HPF) was performed based on firth logistic regression model adjusted for age group and diet restriction.||1610.749|6.294|0.001
70922043|NCT02605837|141334382|SUPERIORITY||Difference in Least square mean|-28.4|||<|0.001||95.0|-35.0|-21.8|||ANCOVA|||This analysis of proximal eosinophil count was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline Peak Eosinophil Count as a continuous covariate.||-21.8|-35.0|<0.001
70922044|NCT02605837|141334382|SUPERIORITY||Difference in Least square mean|-30.4|||<|0.001||95.0|-38.1|-22.7|||ANCOVA|||This analysis of mid eosinophil count was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline Peak Eosinophil Count as a continuous covariate.||-22.7|-38.1|<0.001
70922045|NCT02605837|141334382|SUPERIORITY||Difference in Least square mean|-33.1|||<|0.001||95.0|-40.7|-25.5|||ANCOVA|||This analysis of distal eosinophil count was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline Peak Eosinophil Count as a continuous covariate||-25.5|-40.7|<0.001
70922046|NCT02605837|141334382|SUPERIORITY||Difference in LS Mean|-47.6|||<|0.001|TWO_SIDED|95.0|-56.4|-38.8|||ANCOVA|||This analysis of maximum eosinophil count was from the ANCOVA model with treatment group and age group as factors and the baseline Peak eosinophil count as a continuous covariate.||-38.8|-56.4|<0.001
70922047|NCT02605837|141334383|SUPERIORITY||Difference in Least square mean|-0.19|||<|0.001||95.0|-0.22|-0.16|||ANCOVA|||This analysis of histopathologic epithelial features combined grade TSR was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline Peak Eosinophil Count as a continuous covariate.||-0.16|-0.22|<0.001
71034097|NCT02554890|141577787|OTHER||expon. back transformed from LS means|0.7143|||<|0.0001|TWO_SIDED|95.0|0.6315|0.808||ANCOVA model for a log-scaled response with treatment group as a class variable and biomarker baseline value in logarithmic scale as a continuous covariate.|ANCOVA||Geometric Mean Ratio: Sacubitril/ Valsartan vs. Enalapril|||0.8080|0.6315|<.0001
71034098|NCT02554890|141577791|OTHER||exponentially back transformed from LS m|0.8487||||0.0011|TWO_SIDED|95.0|0.7694|0.9361|||ANCOVA||Geometric Mean Ratio: Sacubitril/ Valsartan vs. Enalapril|||0.9361|0.7694|0.0011
71034099|NCT02554890|141577792|OTHER||expon. back transformed from LS means|1.6487|||<|0.0001|TWO_SIDED|95.0|1.4559|1.8669|||ANCOVA||Geometric Mean Ratio: Sacubitril/ Valsartan vs. Enalapril|||1.8669|1.4559|<.0001
71095711|NCT02762604|141699841|SUPERIORITY||Mean Difference (Net)|2.43|STANDARD_ERROR_OF_MEAN|4.29|||TWO_SIDED|95.0|-5.98|10.84|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in total free recall pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||10.84|-5.98|
70975665|NCT04660643|141459075|SUPERIORITY||LS Mean difference|-5.54|STANDARD_ERROR_OF_MEAN|1.139|<|0.001|TWO_SIDED|95.0|-7.76|-3.28|||Mixed Models Analysis|||Total Cholesterol||-3.28|-7.76|<.001
71034100|NCT02554890|141577793|OTHER||expon. back transformed from LS means|1.4186|||<|0.0001|TWO_SIDED|95.0|1.3248|1.519|||ANCOVA||Geometric Mean Ratio: Sacubitril/ Valsartan vs. Enalapril|||1.5190|1.3248|<.0001
71095712|NCT02762604|141699842|SUPERIORITY||Mean Difference (Net)|-1.94|STANDARD_ERROR_OF_MEAN|2.01|||TWO_SIDED|95.0|-5.88|2.0|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in delayed figure copy recall pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||2.00|-5.88|
71095713|NCT02762604|141699843|SUPERIORITY||Mean Difference (Net)|-6.36|STANDARD_ERROR_OF_MEAN|6.96|||TWO_SIDED|95.0|-20.01|7.28|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in word fluency pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||7.28|-20.01|
70922048|NCT02605837|141334383|SUPERIORITY||Difference in Least square mean|-0.2|||<|0.001||95.0|-0.2|-0.2|||ANCOVA|||This analysis of histopathologic epithelial features combined stage TSR was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline Peak Eosinophil Count as a continuous covariate.||-0.2|-0.2|<0.001
70922049|NCT02605837|141334384|SUPERIORITY||Odds Ratio (OR)|1.42||||0.164|TWO_SIDED|95.0|0.866|2.333|||Regression, Logistic|||Dysphagia symptom response (binary response) at the final treatment period was performed based on logistic regression model adjusted for age group and diet restriction.||2.333|0.866|0.164
70922050|NCT02605837|141334385|SUPERIORITY||Odds Ratio (OR)|91.86||||0.001|TWO_SIDED|95.0|5.687|1483.68|||Firth logistic regression|||Overall binary response I at the final treatment period was performed based on firth logistic regression model adjusted for age group and diet restriction.||1483.680|5.687|0.001
70922051|NCT02605837|141334386|SUPERIORITY||Odds Ratio (OR)|61.68||||0.004|TWO_SIDED|95.0|3.836|991.858|||Firth logistic regression|||Overall binary response II at the final treatment period was perfomed based on based on firth logistic regression model adjusted for age group and diet restriction.||991.858|3.836|0.004
70922052|NCT02605837|141334387|SUPERIORITY||Difference in Least square mean|-6.41||||0.004||95.0|-10.757|-2.063|||ANCOVA|||This analysis was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline DSQ + Pain score as a continuous covariate.||-2.063|-10.757|0.004
70922053|NCT02605837|141334388|SUPERIORITY||Difference in Least square mean|-2.46||||0.002||95.0|-4.018|-0.909|||ANCOVA|||This analysis was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline DSQ Pain score as a continuous covariate.||-0.909|-4.018|0.002
70922054|NCT02652260|141334397|OTHER|The Immediate Switch group will be considered statistically significantly smaller than the Delayed Switch group if the upper bound of the 95% confidence interval for the treatment difference is less than 0.|Estimated Difference|4.65||||0.331|TWO_SIDED|95.0|-15.92|24.85|||Miettinen and Nurminen|||Treatment Difference: Immediate Switch minus Delayed Switch|The 95% confidence interval (CI) was calculated by the method of Miettinen and Nurminen.|24.85|-15.92|0.331
70975666|NCT04660643|141459075|SUPERIORITY||LS Mean difference|-6.57|STANDARD_ERROR_OF_MEAN|1.709|<|0.001|TWO_SIDED|95.0|-9.87|-3.15|||Mixed Models Analysis|||LDL Cholesterol||-3.15|-9.87|<.001
70975667|NCT04660643|141459075|SUPERIORITY||LS Mean difference|3.2|STANDARD_ERROR_OF_MEAN|1.33||0.014|TWO_SIDED|95.0|0.6|5.8|||Mixed Models Analysis|||HDL Cholesterol||5.8|0.6|0.014
70975668|NCT04660643|141459075|SUPERIORITY||LS Mean difference|-19.7|STANDARD_ERROR_OF_MEAN|2.25|<|0.001|TWO_SIDED|95.0|-24.0|-15.1|||Mixed Models Analysis|||VLDL Cholesterol||-15.1|-24.0|<.001
71034101|NCT02554890|141577794|OTHER||expon. back transformed from LS means|1.4745|||<|0.0001|TWO_SIDED|95.0|1.3752|1.581|||ANCOVA||Geometric Mean Ratio: Sacubitril/ Valsartan vs. Enalapril|||1.5810|1.3752|<.0001
71034102|NCT02554890|141577795|OTHER||expon. back transformed from LS means|0.7133|||<|0.0001|TWO_SIDED|95.0|0.6171|0.8245||ANCOVA model for a log-scaled response with treatment group as a class variable and biomarker baseline value in logarithmic scale as a continuous covariate.|ANCOVA||Geometric Mean Ratio: Sacubitril/Valsartan vs. Enalapril|||0.8245|0.6171|<.0001
71034103|NCT01521780|141577798|SUPERIORITY_OR_OTHER||Within subject coefficient of variation|0.0803|||||ONE_SIDED|90.0||0.1163||||||||0.1163||
71034104|NCT01521780|141577799|SUPERIORITY_OR_OTHER||Within subject coefficient of variation|0.0555|||||ONE_SIDED|90.0||0.0733||||||||0.0733||
71034105|NCT03043872|141577803|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0047|TWO_SIDED|95.0|0.591|0.909||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and confidence intervals (CIs) were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + EP vs EP. The global cohort interim analysis of OS was based on a Lan-DeMets alpha spending function with O'Brien Fleming type boundary, using the actual number of events observed as a proportion of the planned total. Boundary for declaring statistical significance was 0.0178 for a 4% overall alpha. Hazard Ratio (HR) \<1 favors D + EP to be associated with a longer OS than EP.||0.909|0.591|0.0047
70922055|NCT02652260|141334398|OTHER|The Immediate Switch group will be considered statistically significantly smaller than the Delayed Switch group if the upper bound of the 95% confidence interval for the treatment difference is less than 0.|Estimated Difference|-18.61|||||TWO_SIDED|95.0|-38.14|2.51||||||Treatment Difference: Immediate Switch minus Delayed Switch|The 95% CI was calculated by the method of Miettinen and Nurminen.|2.51|-38.14|
70922056|NCT02652260|141334399|OTHER||Estimated Difference|-2.0|||||TWO_SIDED|95.0|-10.5|6.5||||||Treatment Difference: Immediate Switch minus Delayed Switch|The 95% CI was based on a t-distribution.|6.5|-10.5|
70922057|NCT02652260|141334400|OTHER||Estimated Difference|3.6|||||TWO_SIDED|95.0|-4.1|11.3||||||Treatment Difference: Immediate Switch minus Delayed Switch|The 95% CI was calculated by the method of Miettinen and Nurminen.|11.3|-4.1|
70922058|NCT02652260|141334401|OTHER|The 95% CI was calculated by the method of Miettinen and Nurminen.|Difference in Percentage|-38.4|||||TWO_SIDED|95.0|-51.2|-23.8||||||Change from time of switch to 24 weeks post-switch: Treatment difference in percent response|Week 24 Post-switch minus Time of switch|-23.8|-51.2|
70922059|NCT02652260|141334402|OTHER|The 95% CI was based on a t-distribution.|Mean Difference (Final Values)|-13.4|||||TWO_SIDED|95.0|-16.8|-10.1||||||Change from time of switch to 24 weeks post-switch: Treatment difference in score|Week 24 Post-switch minus Time of switch|-10.1|-16.8|
70922060|NCT02652260|141334403|OTHER|The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment|Difference Estimate|-9.02|||||TWO_SIDED|95.0|-15.69|-2.35||||||Difference Estimate: LDL Cholesterol|ISG minus DSG|-2.35|-15.69|
70922061|NCT02652260|141334403|OTHER|The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment|Difference Estimate|-13.57|||||TWO_SIDED|95.0|-20.79|-6.35||||||Difference Estimate: Non-HDL Cholesterol|ISG minus DSG|-6.35|-20.79|
70922062|NCT02652260|141334403|OTHER|The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment|Difference Estimate|-21.42|||||TWO_SIDED|95.0|-29.63|-13.21||||||Difference Estimate: Cholesterol|ISG minus DSG|-13.21|-29.63|
70922063|NCT02652260|141334403|OTHER|The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment|Difference Estimate|-8.18|||||TWO_SIDED|95.0|-11.76|-4.6||||||Difference Estimate: HDL Cholesterol|ISG minus DSG|-4.60|-11.76|
70922064|NCT02652260|141334403|OTHER|The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment|Difference Estimate|-22.18|||||TWO_SIDED|95.0|-38.52|-5.84||||||Difference Estimate: Triglyceride|ISG minus DSG|-5.84|-38.52|
70922065|NCT03899961|141334467|SUPERIORITY|Median regression model for the change from baseline, model was adjusted for treatment, bootstrap was used for the confidence interval|Median Difference (Net)|0.0||||0.05|TWO_SIDED|95.0|-1.09|1.09||Median regression model for the change from baseline, model was adjusted for treatment, bootstrap was used for the confidence interval|Median regression model for the change f|||Median regression model for the change from baseline, model was adjusted for treatment, bootstrap was used for the confidence interval||1.09|-1.09|0.05
70922066|NCT05656911|141334471|OTHER|Bayesian analysis according to estimand|Mean Difference (Final Values)|-5.0|||||TWO_SIDED|95.0|-29.0|18.0|||||Posterior probability is 34.0%|Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.||18.0|-29.0|
70922067|NCT05656911|141334472|OTHER||Mean Difference (Final Values)|11.31||||0.257|TWO_SIDED|95.0|-8.26|30.87||two-sided. No adjustment for multiple comparisons.|ANCOVA||LS mean (%)|The analysis of covariance (ANCOVA) model includes treatment group as fixed effect and the EASI baseline value as covariate.||30.87|-8.26|0.257
70922068|NCT05656911|141334473|OTHER|Bayesian analysis according to estimand|Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-27.0|22.1|||||Posterior probability is 41.7%|Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.||22.1|-27.0|
70922069|NCT05656911|141334474|OTHER|Bayesian analysis according to estimand|Mean Difference (Final Values)|-4.6|||||TWO_SIDED|95.0|-25.6|13.4|||||Posterior probability is 31.5%|Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.||13.4|-25.6|
70922070|NCT05656911|141334475|OTHER|Bayesian analysis according to estimand|Mean Difference (Final Values)|-12.5|||||TWO_SIDED|95.0|-34.1|7.0|||||Posterior probability is 10.8%|Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.||7.0|-34.1|
70922071|NCT05656911|141334476|OTHER||Mean Difference (Final Values)|7.06||||0.166|TWO_SIDED|95.0|-2.92|17.03||two-sided. No adjustment for multiple comparisons.|ANCOVA|||The analysis of covariance (ANCOVA) model includes treatment group as fixed effect and the EASI baseline value as covariate.||17.03|-2.92|0.166
70922072|NCT05656911|141334477|OTHER|Bayesian analysis according to estimand|Mean Difference (Final Values)|-8.4|||||TWO_SIDED|95.0|-30.4|11.0|||||Posterior probability is 20.5%|Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.||11.0|-30.4|
71095714|NCT02762604|141699844|SUPERIORITY||Mean Difference (Net)|5.73|STANDARD_ERROR_OF_MEAN|6.25|||TWO_SIDED|95.0|-6.51|17.97|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in semantic fluency pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||17.97|-6.51|
70922073|NCT05656911|141334479|OTHER||Mean Difference (Final Values)|6.68||||0.396|TWO_SIDED|95.0|-8.75|22.11||two-sided. No adjustment for multiple comparisons.|ANCOVA|||The analysis of covariance (ANCOVA) model includes treatment group as fixed effect and the EASI baseline value as covariate.||22.11|-8.75|0.396
70975669|NCT04660643|141459075|SUPERIORITY||LS Mean difference|-20.6|STANDARD_ERROR_OF_MEAN|2.27|<|0.001|TWO_SIDED|95.0|-24.9|-16.0|||Mixed Models Analysis|||Triglycerides||-16|-24.9|<.001
71034106|NCT03043872|141577804|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0032|TWO_SIDED|95.0|0.625|0.91||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + EP vs EP. HR \<1 favors D + EP to be associated with a longer OS than EP.||0.910|0.625|0.0032
71095715|NCT02762604|141699845|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|8.2|||TWO_SIDED|95.0|-16.1|16.03||||||A linear mixed effects model was used to compare changes in digit symbol substitution performance pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)|The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|16.03|-16.10|
70975670|NCT04660643|141459075|SUPERIORITY||LS Mean difference|-10.8|STANDARD_ERROR_OF_MEAN|3.79||0.008|TWO_SIDED|95.0|-17.9|-3.0|||Mixed Models Analysis|||FFA||-3.0|-17.9|0.008
70975671|NCT04660643|141459076|SUPERIORITY||LS Mean difference|-6.4|||<|0.001|TWO_SIDED|95.0|-8.1|-4.6|||Mixed Models Analysis|||SBP||-4.6|-8.1|<.001
70975672|NCT04660643|141459076|SUPERIORITY||LS Mean difference|-3.6|||<|0.001|TWO_SIDED|95.0|-4.8|-2.4|||Mixed Models Analysis|||DBP||-2.4|-4.8|<.001
70975673|NCT04660643|141459077|SUPERIORITY||LS Mean difference|2.6|||<|0.001|TWO_SIDED|95.0|1.7|3.5|||ANCOVA|||||3.5|1.7|<.001
70975674|NCT04660643|141459078|SUPERIORITY||LS Mean difference|9.4|||<|0.001|TWO_SIDED|95.0|6.8|12.0|||ANCOVA|||||12.0|6.8|<0.001
70975675|NCT04660643|141459079|SUPERIORITY||Odds Ratio (OR)|95.91|||<|0.001|TWO_SIDED|95.0|54.72|168.09|||Regression, Logistic|||||168.09|54.72|<0.001
70975676|NCT04660643|141459080|SUPERIORITY||Odds Ratio (OR)|47.27|||<|0.001|TWO_SIDED|95.0|18.32|121.99|||Regression, Logistic|||≥5% body weight reduction from baseline||121.99|18.32|<0.001
70975677|NCT04660643|141459080|SUPERIORITY||Odds Ratio (OR)|71.51|||<|0.001|TWO_SIDED|95.0|34.46|148.39|||Regression, Logistic|||≥10% body weight reduction from baseline||148.39|34.46|<0.001
71095716|NCT02762604|141699847|SUPERIORITY||Mean Difference (Net)|3.64|STANDARD_ERROR_OF_MEAN|7.54|||TWO_SIDED|95.0|-11.14|18.42|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in immediate maze performance pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||18.42|-11.14|
70975678|NCT04660643|141459080|SUPERIORITY||Odds Ratio (OR)|79.99|||<|0.001|TWO_SIDED|95.0|42.06|152.14|||Regression, Logistic|||≥15% body weight reduction from baseline||152.14|42.06|<0.001
70975679|NCT04660643|141459080|SUPERIORITY||Odds Ratio (OR)|140.84|||<|0.001|TWO_SIDED|95.0|66.06|300.29|||Regression, Logistic|||≥20% body weight reduction from baseline||300.29|66.06|<0.001
70975680|NCT04660643|141459081|SUPERIORITY||Hazard Ratio (HR)|0.013|||<|0.001|TWO_SIDED|95.0|0.004|0.046|||Log Rank||Unstratified hazard ratio from Cox proportional hazard model with Baseline Weight (kg), Analysis Country, Sex, IWRS MTD at Week 36, Weight at randomization (kg) as covariates.|||0.046|0.004|<.001
70975681|NCT04660643|141459082|SUPERIORITY||LS Mean difference|-6.4|||<|0.001|TWO_SIDED|95.0|-6.8|-6.0|||Mixed Models Analysis|||||-6.0|-6.8|<.001
70975682|NCT04660643|141459083|SUPERIORITY||LS Mean difference|-17.6|||<|0.001|TWO_SIDED|95.0|-18.8|-16.4|||Mixed Models Analysis|||||-16.4|-18.8|<.001
70975683|NCT04660643|141459084|SUPERIORITY||LS Mean difference|-16.4|||<|0.001|TWO_SIDED|95.0|-17.5|-15.4|||Mixed Models Analysis|||||-15.4|-17.5|<.001
70975684|NCT04660643|141459085|SUPERIORITY||LS Mean difference|-13.6|||<|0.001|TWO_SIDED|95.0|-15.1|-12.2|||Mixed Models Analysis|||||-12.2|-15.1|<.001
70975685|NCT04660643|141459086|SUPERIORITY||LS Mean difference|-8.92|||<|0.001|TWO_SIDED|95.0|-10.4|-7.43|||Mixed Models Analysis|||||-7.43|-10.40|<.001
70975686|NCT04660643|141459087|SUPERIORITY||LS Mean difference|-0.34|||<|0.001|TWO_SIDED|95.0|-0.39|-0.29|||Mixed Models Analysis|||||-0.29|-0.39|<.001
70975687|NCT04660643|141459088|SUPERIORITY||LS Mean difference|-34.6|STANDARD_ERROR_OF_MEAN|3.25|<|0.001|TWO_SIDED|95.0|-40.6|-27.9|||Mixed Models Analysis|||||-27.9|-40.6|<.001
70975688|NCT04660643|141459089|SUPERIORITY||LS Mean difference|-7.02|STANDARD_ERROR_OF_MEAN|1.158|<|0.001|TWO_SIDED|95.0|-9.27|-4.72|||Mixed Models Analysis|||Total Cholesterol||-4.72|-9.27|<.001
70975689|NCT04660643|141459089|SUPERIORITY||LS Mean difference|-7.62|STANDARD_ERROR_OF_MEAN|1.707|<|0.001|TWO_SIDED|95.0|-10.91|-4.21|||Mixed Models Analysis|||LDL Cholesterol||-4.21|-10.91|<.001
70975690|NCT04660643|141459089|SUPERIORITY||LS Mean difference|2.6|STANDARD_ERROR_OF_MEAN|1.418||0.064|TWO_SIDED|95.0|-0.14|5.43|||Mixed Models Analysis|||HDL Cholesterol||5.43|-0.14|0.064
70975691|NCT04660643|141459089|SUPERIORITY||LS Mean difference|-20.1|STANDARD_ERROR_OF_MEAN|2.38|<|0.001|TWO_SIDED|95.0|-24.7|-15.3|||Mixed Models Analysis|||VLDL Cholesterol||-15.3|-24.7|<.001
70975692|NCT04660643|141459089|SUPERIORITY||LS Mean difference|-21.2|STANDARD_ERROR_OF_MEAN|2.38|<|0.001|TWO_SIDED|95.0|-25.8|-16.4|||Mixed Models Analysis|||Triglycerides||-16.4|-25.8|<.001
70975693|NCT04660643|141459089|SUPERIORITY||LS Mean difference|-11.83|STANDARD_ERROR_OF_MEAN|3.793||0.004|TWO_SIDED|95.0|-18.98|-4.06|||Mixed Models Analysis|||FFA||-4.06|-18.98|0.004
70975694|NCT04660643|141459090|SUPERIORITY||LS Mean difference|-6.9|||<|0.001|TWO_SIDED|95.0|-8.7|-5.1|||Mixed Models Analysis|||SBP||-5.1|-8.7|<.001
70975695|NCT04660643|141459090|SUPERIORITY||LS Mean difference|-3.8|||<|0.001|TWO_SIDED|95.0|-5.1|-2.6|||Mixed Models Analysis|||DBP||-2.6|-5.1|<.001
70975696|NCT04660643|141459091|SUPERIORITY||LS Mean difference|2.7|||<|0.001|TWO_SIDED|95.0|1.7|3.7|||ANCOVA|||||3.7|1.7|<.001
70975697|NCT04660643|141459092|SUPERIORITY||LS Mean difference|9.3|||<|0.001|TWO_SIDED|95.0|6.5|12.0|||ANCOVA|||||12.0|6.5|<.001
70975698|NCT01688050|141459094|OTHER|The primary safety endpoint of this study is analyzed using only descriptive statistics and it is not analyzed for the purpose of statistical inference|All-cause mortality rate (%)|2.0|||||TWO_SIDED|95.0|0.0|5.88|||||Wald method|||5.88|0|
70975699|NCT01688050|141459095|OTHER|The primary safety endpoint of this study is analyzed using only descriptive statistics and it is not analyzed for the purpose of statistical inference|Aortic injury-related mortality rate (%)|0.0|||||TWO_SIDED|95.0|0.0|7.1|||||Exact method|||7.1|0|
70975700|NCT01688050|141459096|OTHER|The primary effectiveness endpoint of this study is analyzed using only descriptive statistics and it is not analyzed for the purpose of statistical inference|Device success rate (%)|96.0|||||TWO_SIDED|95.0|90.6|100.0|||||Wald method|||100|90.6|
70975701|NCT01872338|141459097|SUPERIORITY||Incident Rate Ratio|0.5||||0.015|TWO_SIDED|95.0|0.29|0.87|||negative binomial regression|||||.87|.29|.015
70975702|NCT01872338|141459098|SUPERIORITY||Incident Rate Ratio|0.43||||0.01|TWO_SIDED|95.0|0.22|0.82|||negative binomial regression|||||.82|.22|.01
70975703|NCT01872338|141459099|SUPERIORITY|||||||0.34|||||||Regression, Linear|repeated measures, overall time by condition effect||||||.34
70975704|NCT01872338|141459100|SUPERIORITY|||||||0.23||||||repeated measures, overall time by condition effect|Regression, Linear|||||||.23
70975705|NCT03213366|141459135|SUPERIORITY||Slope|-0.0095||||0.5783|TWO_SIDED|95.0|-0.04676|0.02776|||Mixed Models Analysis|||At 6 weeks.||0.02776|-0.04676|0.5783
70975706|NCT03213366|141459135|SUPERIORITY||Slope|-0.01692||||0.3185|TWO_SIDED|95.0|-0.05318|0.01933|||Mixed Models Analysis|||At 12 weeks.||0.01933|-0.05318|0.3185
70975707|NCT03213366|141459136|SUPERIORITY||Slope|0.03674||||0.07863|TWO_SIDED|95.0|-0.00516|0.07863|||Mixed Models Analysis|||At 6 weeks.||0.07863|-0.00516|0.07863
70975708|NCT03213366|141459136|SUPERIORITY||Slope|0.02594||||0.1999|TWO_SIDED|95.0|-0.01648|0.06836|||Mixed Models Analysis|||At 12 weeks.||0.06836|-0.01648|0.1999
70975709|NCT03213366|141459137|SUPERIORITY||Slope|0.000443||||0.8963|TWO_SIDED||||||Mixed Models Analysis|||At 6 weeks.||||0.8963
70975710|NCT03213366|141459137|SUPERIORITY||Slope|0.004308||||0.3229|TWO_SIDED||||||Mixed Models Analysis|||At 12 weeks||||0.3229
70975711|NCT03213366|141459138|SUPERIORITY||Slope|0.008705||||0.2433|TWO_SIDED|||||This t-test was for the random effects model not for comparing the difference between the arms.|Mixed Models Analysis|||||||0.2433
70975712|NCT03213366|141459138|SUPERIORITY||Slope|0.01358||||0.0839|TWO_SIDED||||||Mixed Models Analysis|||At 12 weeks.||||0.0839
70975713|NCT03213366|141459139|SUPERIORITY||Slope|-0.302||||0.2114|TWO_SIDED||||||Mixed Models Analysis|||At 6 weeks.||||0.2114
70975714|NCT03213366|141459139|SUPERIORITY||Slope|-0.03149||||0.2141|TWO_SIDED||||||Mixed Models Analysis|||At 12 weeks.||||0.2141
70975715|NCT03213366|141459140|SUPERIORITY||Slope|0.0278||||0.0124|TWO_SIDED||||||Mixed Models Analysis|||At 6 weeks.||||0.0124
70975716|NCT03213366|141459140|SUPERIORITY||Slope|0.03052||||0.0022|TWO_SIDED||||||Mixed Models Analysis|||At 12 weeks.||||0.0022
70975717|NCT03213366|141459141|SUPERIORITY||Slope|-0.05747||||0.1021|TWO_SIDED||||||Mixed Models Analysis|||At 6 weeks.||||0.1021
70975718|NCT03213366|141459141|SUPERIORITY||Slope|-0.05101||||0.133|TWO_SIDED||||||Mixed Models Analysis|||At 12 weeks.||||0.133
70975719|NCT03213366|141459142|SUPERIORITY||Slope|-0.0209||||0.0818|TWO_SIDED||||||Mixed Models Analysis|||At 6 weeks.||||0.0818
70975720|NCT03213366|141459142|SUPERIORITY||Slope|0.03103||||0.0334|TWO_SIDED||||||Mixed Models Analysis|||At 12 weeks.||||0.0334
70975721|NCT00666926|141459159|SUPERIORITY_OR_OTHER||Ratio (percent) test / reference|155.66|||||TWO_SIDED|90.0|109.66|220.95|||||Ratio of adjusted geometric means Day 21 versus Day 1. Values have been transformed from the log scale.|Participants in the PF-00562271 125 mg BID cohort who received MDZ (test) administered prior to PF-00562271 (reference) dosing.||220.95|109.66|
70975722|NCT00666926|141459160|SUPERIORITY_OR_OTHER||Ratio (percent) test / reference|315.72|||||TWO_SIDED|90.0|227.6|437.97|||||Ratio of adjusted geometric means Day 21 versus Day 1. Values have been transformed from the log scale.|Participants in the PF-00562271 125 mg BID cohort who received MDZ (test) administered prior to PF-00562271 (reference) dosing.||437.97|227.60|
70975723|NCT00666926|141459161|SUPERIORITY_OR_OTHER||Ratio (percent) test / reference|496.63|||||TWO_SIDED|90.0|206.24|1195.92|||||Ratio of adjusted geometric means Day 21 versus Day 1. Values have been transformed from the log scale.|Participants in the PF-00562271 125 mg BID cohort who received MDZ (test) administered prior to PF-00562271 (reference) dosing.||1195.92|206.24|
70975724|NCT01727258|141459170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.85|STANDARD_ERROR_OF_MEAN|1.72|<|0.001|TWO_SIDED|95.0|7.45|14.25||If Potassium Oxalate Mouthrinse is better than Colgate Regular (p\<0.05), testing would proceed to comparison of Wk 2 Mean Tactile Sensitivity Scores between Potassium Oxalate Mouthrinse and Colgate Regular. Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||14.25|7.45|<0.001
70975725|NCT01727258|141459170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.74|STANDARD_ERROR_OF_MEAN|1.729||0.314|TWO_SIDED|95.0|-5.16|1.67||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.67|-5.16|0.314
70975726|NCT01727258|141459170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.6|STANDARD_ERROR_OF_MEAN|1.735|<|0.001|TWO_SIDED|95.0|9.17|16.03||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||16.03|9.17|<0.001
70975727|NCT01727258|141459171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.08|STANDARD_ERROR_OF_MEAN|1.177|<|0.001|TWO_SIDED|95.0|3.76|8.41||If Potassium Oxalate Mouthrinse is better than Colgate Regular (p\<0.05), testing would proceed to comparison of Wk 2 Mean Tactile Sensitivity Scores between Potassium Oxalate Mouthrinse and Sensodyne. Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||8.41|3.76|<0.001
70975728|NCT01727258|141459171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|1.183||0.881|TWO_SIDED|95.0|-2.16|2.52||The significance threshold level was 0.05 (two-sided). Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.52|-2.16|0.881
70922074|NCT03088813|141334485|OTHER||Hazard Ratio (HR)|1.11||||0.3094|TWO_SIDED|95.0|0.9|1.37|||Stratified log-rank test|From stratified log-rank test, stratified by corrected region and corrected platinum sensitivity.|The associated HR and two-sided 95% Confidence Interval (CI) were estimated using stratified Cox proportional hazards model, stratified by corrected region and corrected platinum sensitivity.|||1.37|0.90|0.3094
70922075|NCT03088813|141334489|OTHER||Hazard Ratio (HR)|0.96||||0.7053|TWO_SIDED|95.0|0.77|1.2||From stratified log-rank test, stratified by corrected region and corrected platinum sensitivity|Stratified log-rank test||The associated HR and two-sided 95% CI were estimated using stratified Cox proportional hazards model, stratified by corrected region and corrected platinum sensitivity.|||1.20|0.77|0.7053
70922076|NCT03088813|141334490|OTHER||Difference in ORR|22.29|||<|0.0001|TWO_SIDED|95.0|13.97|30.61||ORR difference, 95% CI and P-value are obtained from the Cochran-Mantel-Haenszel test stratified by corrected region and corrected platinum sensitivity.|Cochran-Mantel-Haenszel|||||30.61|13.97|<0.0001
70922077|NCT05107401|141334520|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.083|TWO_SIDED|95.0|-4.9|0.3|||Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference between study arms from baseline to the three-month follow-up.|Separate multilevel linear mixed models were calculated for the overall stigma score and then for each of the stigma subscale scores. The multilevel linear mixed models incorporated fixed effects for time (categorical), study arm, and their interaction and included intercept as a random effect. Models were also adjusted for pre-intervention stigma levels, whether the participant had submitted content to the study contest, prior HIV testing, age, sex at birth, and sexual orientation.||0.30|-4.90|0.083
70922078|NCT05107401|141334521|SUPERIORITY||Mean Difference (Final Values)|-0.67||||0.032|TWO_SIDED|95.0|-1.16|-0.18|||Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference between study arms from baseline to the three-month follow-up.|Separate multilevel linear mixed models were calculated for the overall stigma score and then for each of the stigma subscale scores. The multilevel linear mixed models incorporated random fixed effects for time (categorical), study arm, and their interaction and included intercept as a random effect. Models were also adjusted for pre-intervention stigma levels, whether the participant had submitted content to the study contest, age, sex at birth, and sexual orientation.||-0.18|-1.16|0.032
70922079|NCT05107401|141334522|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.48|TWO_SIDED|95.0|-0.72|0.29|||Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference between study arms from baseline to the three-month follow-up.|Separate multilevel linear mixed models were calculated for the overall stigma score and then for each of the stigma subscale scores. The multilevel linear mixed models incorporated random fixed effects for time (categorical), study arm, and their interaction and included intercept as a random effect. Models were also adjusted for pre-intervention stigma levels, whether the participant had submitted content to the study contest, prior HIV testing, age, sex at birth, and sexual orientation.||0.29|-0.72|0.48
70922080|NCT05107401|141334523|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.48|TWO_SIDED|95.0|-1.49|0.29|||Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference between study arms from baseline to the three-month follow-up.|Separate multilevel linear mixed models were calculated for the overall stigma score and then for each of the stigma subscale scores. The multilevel linear mixed models incorporated random fixed effects for time (categorical), study arm, and their interaction and included intercept as a random effect. Models were also adjusted for pre-intervention stigma levels, whether the participant had submitted content to the study contest, prior HIV testing, age, sex at birth, and sexual orientation.||0.29|-1.49|0.48
70922081|NCT05107401|141334524|SUPERIORITY||Mean Difference (Final Values)|-1.05||||0.37|TWO_SIDED|95.0|-2.6|0.51|||Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference between study arms from baseline to the three-month follow-up.|Separate multilevel linear mixed models were calculated for the overall stigma score and then for each of the stigma subscale scores. The multilevel linear mixed models incorporated random fixed effects for time (categorical), study arm, and their interaction and included intercept as a random effect. Models were also adjusted for pre-intervention stigma levels, whether the participant had submitted content to the study contest, prior HIV testing, age, sex at birth, and sexual orientation.||0.51|-2.60|0.37
70922082|NCT05107401|141334525|SUPERIORITY||Risk Ratio (RR)|1.13||||0.099|TWO_SIDED|95.0|0.98|1.32|||Regression, Logistic||The statistical values presented are the relative risk between study arms at the three-month follow-up.|We used a generalized linear model using a binomial distribution to examine whether the intervention was associated with increased HIV self-testing uptake in the follow-up period. The model was adjusted for history of HIV testing (pre-intervention testing and testing prior to the study), whether the participant had submitted content to the JasSpark contest, and if the participant had a main intimate partner (e.g., girlfriend/boyfriend, spouse).||1.32|0.98|0.099
70922083|NCT05107401|141334526|SUPERIORITY||Mean Difference (Final Values)|-5.09||||0.012|TWO_SIDED|95.0|-8.59|-1.58||To account for multiple comparisons arising from analyses of moderating effects, the false discovery rate (FDR) was controlled using Benjamini-Hochberg procedures in a tiered approach.|Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference in females between study arms from baseline to the three-month follow-up.|Sex was marginally significant in the initial multilevel mixed models, therefore, we examined potential moderation effects of sex on stigma changes. Fixed effects corresponding to the two-way interactions involving sex, time, and/or arm, as well as the three-way interaction of sex, time, and arm, were added to the models.||-1.58|-8.59|0.012
70975729|NCT01727258|141459171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.91|STANDARD_ERROR_OF_MEAN|1.182|<|0.001|TWO_SIDED|95.0|3.57|8.24||Significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||8.24|3.57|<0.001
70975730|NCT01727258|141459172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.72|STANDARD_ERROR_OF_MEAN|2.866||0.02|TWO_SIDED|95.0|-12.38|-1.05||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-1.05|-12.38|0.020
70975731|NCT01727258|141459172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|2.86||0.964|TWO_SIDED|95.0|-5.52|5.78||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||5.78|-5.52|0.964
70975732|NCT01727258|141459172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.85|STANDARD_ERROR_OF_MEAN|2.845||0.017|TWO_SIDED|95.0|-12.47|-1.23||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-1.23|-12.47|0.017
70975733|NCT01727258|141459173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.92|STANDARD_ERROR_OF_MEAN|3.327||0.039|TWO_SIDED|95.0|-13.5|-0.35||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.35|-13.50|0.039
70975734|NCT01727258|141459173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.06|STANDARD_ERROR_OF_MEAN|3.317||0.13|TWO_SIDED|95.0|-1.5|11.61||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||11.61|-1.50|0.130
70922084|NCT05107401|141334526|SUPERIORITY||Mean Difference (Final Values)|1.58||||0.56|TWO_SIDED|95.0|-2.26|5.42||To account for multiple comparisons arising from analyses of moderating effects, the false discovery rate (FDR) was controlled using Benjamini-Hochberg procedures in a tiered approach.|Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference in males between study arms from baseline to the three-month follow-up.|Sex was marginally significant in the initial multilevel mixed models, therefore, we examined potential moderation effects of sex on stigma changes. Fixed effects corresponding to the two-way interactions involving sex, time, and/or arm, as well as the three-way interaction of sex, time, and arm, were added to the models.||5.42|-2.26|0.56
70922085|NCT03363854|141334527|SUPERIORITY||Risk Difference (RD)|12.4||||0.015|TWO_SIDED|95.0|2.9|21.9||The primary endpoints were tested sequentially at a 5% significance level.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants who achieved IGA 0 or 1 at Week 16 were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their IGA value at Week 16. The null hypothesis of no difference in response rates between tralokinumab Q2W+TCS and placebo+TCS was tested against the 2-sided alternative that there was a difference.||21.9|2.9|0.015
70922086|NCT03363854|141334528|SUPERIORITY||Risk Difference (RD)|20.2|||<|0.001|TWO_SIDED|95.0|9.8|30.6||The primary endpoints were tested sequentially at a 5% significance level.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants who achieved at least 75% reduction in EASI at Week 16 were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their EASI value at Week 16. The null hypothesis of no difference in response rates between tralokinumab Q2W+TCS and placebo+TCS was tested against the 2-sided alternative that there was a difference.||30.6|9.8|<0.001
70922087|NCT03363854|141334529|SUPERIORITY||Risk Difference (RD)|11.3||||0.037|TWO_SIDED|95.0|0.9|21.6||This secondary endpoint was tested after the sequential testing of the primary endpoints, if these showed statistical significance.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their Worst daily Pruritus NRS value at Week 16.||21.6|0.9|0.037
70922088|NCT03363854|141334530|SUPERIORITY||Difference|-10.9|||<|0.001|TWO_SIDED|95.0|-15.2|-6.6||This secondary endpoint was tested sequentially using the Holm method for multiplicity adjustment at a 5% significance level after the sequential testing of the primary endpoints and first secondary endpoint, if these showed statistical significance.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.||-6.6|-15.2|<0.001
70922089|NCT03363854|141334531|SUPERIORITY||Difference|-2.9|||<|0.001|TWO_SIDED|95.0|-4.3|-1.6||This secondary endpoint was tested sequentially using the Holm method for multiplicity adjustment at a 5% significance level after sequential testing of the primary endpoints and the first secondary endpoint, if these showed statistical significance.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.||-1.6|-4.3|<0.001
70922090|NCT03363854|141334533|SUPERIORITY||Difference|-3.5||||0.41|TWO_SIDED|95.0|-11.9|4.9||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 1-2 are reported below.||4.9|-11.9|0.41
70922091|NCT03363854|141334533|SUPERIORITY||Difference|-6.9||||0.033|TWO_SIDED|95.0|-13.3|-0.6||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 3-4 are reported below.||-0.6|-13.3|0.033
70922092|NCT03363854|141334533|SUPERIORITY||Difference|-4.7||||0.12|TWO_SIDED|95.0|-10.6|1.2||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 5-6 are reported below.||1.2|-10.6|0.12
70922093|NCT03363854|141334533|SUPERIORITY||Difference|-7.3||||0.043|TWO_SIDED|95.0|-14.3|-0.2||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 7-8 are reported below.||-0.2|-14.3|0.043
70922094|NCT03363854|141334533|SUPERIORITY||Difference|-9.1||||0.002|TWO_SIDED|95.0|-14.8|-3.4||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 9-10 are reported below.||-3.4|-14.8|0.002
70922095|NCT03363854|141334533|SUPERIORITY||Difference|-8.0||||0.001|TWO_SIDED|95.0|-12.8|-3.2||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 11-12 are reported below.||-3.2|-12.8|0.001
70922096|NCT03363854|141334533|SUPERIORITY||Difference|-10.2|||<|0.001|TWO_SIDED|95.0|-15.8|-4.7||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 13-14 are reported below.||-4.7|-15.8|<0.001
70922097|NCT03363854|141334533|SUPERIORITY||Difference|-8.6||||0.002|TWO_SIDED|95.0|-14.1|-3.2||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 15-16 are reported below.||-3.2|-14.1|0.002
70975735|NCT01727258|141459173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.98|STANDARD_ERROR_OF_MEAN|3.313|<|0.001|TWO_SIDED|95.0|-18.53|-5.43||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-5.43|-18.53|<0.001
70975736|NCT01727258|141459174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.26|STANDARD_ERROR_OF_MEAN|3.163||0.01|TWO_SIDED|95.0|-14.51|-2.0||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-2.00|-14.51|0.010
70975737|NCT01727258|141459174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.26|STANDARD_ERROR_OF_MEAN|3.16||0.179|TWO_SIDED|95.0|-1.98|10.51||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||10.51|-1.98|0.179
70975738|NCT01727258|141459174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.52|STANDARD_ERROR_OF_MEAN|3.172|<|0.001|TWO_SIDED|95.0|-18.79|-6.25||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-6.25|-18.79|<0.001
70975739|NCT01727258|141459175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.93|STANDARD_ERROR_OF_MEAN|3.543|<|0.001|TWO_SIDED|95.0|-18.93|-4.93||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-4.93|-18.93|<0.001
70975740|NCT01727258|141459175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.54|STANDARD_ERROR_OF_MEAN|3.534||0.119|TWO_SIDED|95.0|-1.44|12.53||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||12.53|-1.44|0.119
70975741|NCT01727258|141459175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.47|STANDARD_ERROR_OF_MEAN|3.566|<|0.001|TWO_SIDED|95.0|-24.52|-10.42||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-10.42|-24.52|<0.001
70975742|NCT00820573|141459176|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||"A general unstructured variance-covariance matrix (ANOVA) was applied for measurements at different periods. Between-group comparisons after 6 wks of treatment were assessed using the ANOVA model at alpha=0.05 (two-sided).~16 subjects provide \~90% power to detect difference in EGP of 0.28 mg/kg.min (95% CI = 0.17 mg/kg.min)."||||<0.05
70975743|NCT00820573|141459177|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||multivariate analysis was performed to compare results amongst all four groups||||<0.05
70975744|NCT00820573|141459178|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||ANOVA||||0.05
70975745|NCT00820573|141459179|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||||||0.05
70975746|NCT01360645|141459195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.12||||0.0001|TWO_SIDED|95.0|-4.7|-1.54|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||The primary analysis was performed on the Efficacy Sample by fitting a Mixed Model Repeated Measures (MMRM) analysis with an unstructured variance covariance structure in which the change from the end of Phase A (Week 8) in MADRS Total Score (at Weeks 9 to 14) was the dependent variable. The model included fixed class effect terms for treatment, trial site, visit week, and an interaction term of treatment by visit week.||-1.54|-4.70|0.0001
70975747|NCT01360645|141459196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.21||||0.0002|TWO_SIDED|95.0|-4.87|-1.54|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||||-1.54|-4.87|0.0002
70975748|NCT01360645|141459197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.0372|TWO_SIDED|95.0|-0.86|-0.03|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||||-0.03|-0.86|0.0372
70975749|NCT01360645|141459198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0349|TWO_SIDED|95.0|-0.88|-0.03|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||||-0.03|-0.88|0.0349
70975750|NCT01360645|141459199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29||||0.008|TWO_SIDED|95.0|-2.25|-0.34|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9||-0.34|-2.25|0.0080
70975751|NCT01360645|141459199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72||||0.0045|TWO_SIDED|95.0|-2.91|-0.54|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10||-0.54|-2.91|0.0045
70975752|NCT01360645|141459199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.63||||0.0001|TWO_SIDED|95.0|-3.96|-1.3|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11||-1.30|-3.96|0.0001
70975753|NCT01360645|141459199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.59||||0.0004|TWO_SIDED|95.0|-4.01|-1.18|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12||-1.18|-4.01|0.0004
70975754|NCT01360645|141459199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.19||||0|TWO_SIDED|95.0|-4.68|-1.7|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13||-1.70|-4.68|0.0000
70975755|NCT01360645|141459200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31||||0.0086|TWO_SIDED|95.0|-2.28|-0.34|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9||-0.34|-2.28|0.0086
70975756|NCT01360645|141459200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.52||||0.0149|TWO_SIDED|95.0|-2.74|-0.3|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10||-0.30|-2.74|0.0149
70975757|NCT01360645|141459200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.42||||0.0006|TWO_SIDED|95.0|-3.78|-1.05|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11||-1.05|-3.78|0.0006
70975758|NCT01360645|141459200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.52||||0.0009|TWO_SIDED|95.0|-4.0|-1.04|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12||-1.04|-4.00|0.0009
70975759|NCT01360645|141459200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.28||||0|TWO_SIDED|95.0|-4.84|-3.28|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13||-3.28|-4.84|0.0000
70975760|NCT01360645|141459201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.0022|TWO_SIDED|95.0|-0.38|-0.08|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from Cochran-Mantel-Haenszel (CMH) row mean score differ test controlling for study center.||Statistical analysis for Week 9||-0.08|-0.38|0.0022
70975761|NCT01360645|141459201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.0115|TWO_SIDED|95.0|-0.38|-0.05|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 10||-0.05|-0.38|0.0115
70975762|NCT01360645|141459201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.0255|TWO_SIDED|95.0|-0.41|-0.03|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 11||-0.03|-0.41|0.0255
71034107|NCT03043872|141577804|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0451|TWO_SIDED|95.0|0.682|0.995||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|"D + T + EP vs EP. The alpha level applied at the global cohort final analysis was adjusted (using a generalized Haybittle-Peto method) to account for actual alpha spent at the interim analysis based on the actual final total number of events, and thus maintain control of overall Type I error. Boundary for declaring statistical significance was 0.0418 for a 5% overall alpha.~HR \<1 favors D + T + EP to be associated with a longer OS than EP."||0.995|0.682|0.0451
70975763|NCT01360645|141459201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.0005|TWO_SIDED|95.0|-0.57|-0.16|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 12||-0.16|-0.57|0.0005
70975764|NCT01360645|141459201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.0001|TWO_SIDED|95.0|-0.62|-0.2|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 13||-0.20|-0.62|0.0001
70975765|NCT01360645|141459201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.0005|TWO_SIDED|95.0|-0.6|-0.17|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 14||-0.17|-0.60|0.0005
70975766|NCT01360645|141459202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.001|TWO_SIDED|95.0|-0.4|-0.1|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 9||-0.10|-0.40|0.0010
70975767|NCT01360645|141459202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.029|TWO_SIDED|95.0|-0.37|-0.02|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 10||-0.02|-0.37|0.0290
70975768|NCT01360645|141459202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.0422|TWO_SIDED|95.0|-0.4|-0.01|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 11||-0.01|-0.40|0.0422
70975769|NCT01360645|141459202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.0003|TWO_SIDED|95.0|-0.61|-0.18|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 12||-0.18|-0.61|0.0003
70975770|NCT01360645|141459202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.0002|TWO_SIDED|95.0|-0.64|-0.2|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 13||-0.20|-0.64|0.0002
70975771|NCT01360645|141459202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.0003|TWO_SIDED|95.0|-0.65|-0.19|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 14||-0.19|-0.65|0.0003
70975772|NCT01360645|141459203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.0229|TWO_SIDED|95.0|-0.25|-0.02|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9||-0.02|-0.25|0.0229
70975773|NCT01360645|141459203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.0459|TWO_SIDED|95.0|-0.28|0.0|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10||-0.00|-0.28|0.0459
70975774|NCT01360645|141459203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.0097|TWO_SIDED|95.0|-0.37|-0.05|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11||-0.05|-0.37|0.0097
70975775|NCT01360645|141459203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0038|TWO_SIDED|95.0|-0.42|-0.08|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12||-0.08|-0.42|0.0038
70975776|NCT01360645|141459203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.0001|TWO_SIDED|95.0|-0.54|-0.18|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13||-0.18|-0.54|0.0001
70975777|NCT01360645|141459203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.0004|TWO_SIDED|95.0|-0.52|-0.15|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 14.||-0.15|-0.52|0.0004
70975778|NCT01360645|141459204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.0109|TWO_SIDED|95.0|-0.27|-0.04|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9||-0.04|-0.27|0.0109
70975779|NCT01360645|141459204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.1286|TWO_SIDED|95.0|-0.25|0.03|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10||0.03|-0.25|0.1286
70975780|NCT01360645|141459204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.0521|TWO_SIDED|95.0|-0.32|0.0|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11||0.00|-0.32|0.0521
70975781|NCT01360645|141459204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.0084|TWO_SIDED|95.0|-0.42|-0.06|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12||-0.06|-0.42|0.0084
70975782|NCT01360645|141459204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0003|TWO_SIDED|95.0|-0.54|-0.16|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13||-0.16|-0.54|0.0003
70975783|NCT01360645|141459204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.0006|TWO_SIDED|95.0|-0.53|-0.15|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 14||-0.15|-0.53|0.0006
70975784|NCT01360645|141459205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.57||||0.0139|TWO_SIDED|95.0|-2.82|-0.32|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9||-0.32|-2.82|0.0139
70975785|NCT01360645|141459205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.53||||0.0436|TWO_SIDED|95.0|-3.01|-0.04|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10||-0.04|-3.01|0.0436
70975786|NCT01360645|141459205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.1903|TWO_SIDED|95.0|-2.75|0.55|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11||0.55|-2.75|0.1903
70975787|NCT01360645|141459205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.47||||0.0951|TWO_SIDED|95.0|-3.21|0.26|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12||0.26|-3.21|0.0951
70975788|NCT01360645|141459205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75||||0.0626|TWO_SIDED|95.0|-3.59|0.09|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13||0.09|-3.59|0.0626
70975789|NCT01360645|141459205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.96||||0.0435|TWO_SIDED|95.0|-3.87|-0.06|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 14||-0.06|-3.87|0.0435
70975790|NCT01360645|141459206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71||||0.0069|TWO_SIDED|95.0|-2.95|-0.47|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9||-0.47|-2.95|0.0069
70975791|NCT01360645|141459206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16||||0.1322|TWO_SIDED|95.0|-2.68|0.35|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10||0.35|-2.68|0.1322
70975792|NCT01360645|141459206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72||||0.4055|TWO_SIDED|95.0|-2.41|0.98|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11||0.98|-2.41|0.4055
70975793|NCT01360645|141459206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26||||0.1715|TWO_SIDED|95.0|-3.08|0.55|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12||0.55|-3.08|0.1715
70975794|NCT01360645|141459206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.42||||0.1424|TWO_SIDED|95.0|-3.33|0.48|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13||0.48|-3.33|0.1424
70975795|NCT01360645|141459206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54||||0.127|TWO_SIDED|95.0|-3.52|0.44|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 14||0.44|-3.52|0.1270
70975796|NCT01360645|141459207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.3079|TWO_SIDED|95.0|-0.81|0.26|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Work/School: Week 11||0.26|-0.81|0.3079
70975797|NCT01360645|141459207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.4771|TWO_SIDED|95.0|-0.73|0.34|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Work/School: Week 14||0.34|-0.73|0.4771
70975798|NCT01360645|141459207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0195|TWO_SIDED|95.0|-0.92|-0.08|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Social life: Week 11||-0.08|-0.92|0.0195
71095717|NCT02762604|141699848|SUPERIORITY||Mean Difference (Net)|3.26|STANDARD_ERROR_OF_MEAN|12.2|||TWO_SIDED|95.0|-20.65|27.18|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in delayed maze performance pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||27.18|-20.65|
70975799|NCT01360645|141459207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0323|TWO_SIDED|95.0|-0.96|-0.04|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Social life: Week 14||-0.04|-0.96|0.0323
70975800|NCT01360645|141459207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63||||0.0058|TWO_SIDED|95.0|-1.07|-0.18|||Cochran-Mantel-Haenszel|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Family life: Week 11||-0.18|-1.07|0.0058
70975801|NCT01360645|141459207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.0129|TWO_SIDED|95.0|-1.07|-0.13|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Family life: Week 14||-0.13|-1.07|0.0129
70975802|NCT01360645|141459208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.5151|TWO_SIDED|95.0|-0.71|0.36|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Work/School Week 11||0.36|-0.71|0.5151
70975803|NCT01360645|141459208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.608|TWO_SIDED|95.0|-0.7|0.41|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Work/School Week 14||0.41|-0.70|0.6080
70975804|NCT01360645|141459208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0267|TWO_SIDED|95.0|-0.92|-0.06|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Social life-Week 11||-0.06|-0.92|0.0267
70975805|NCT01360645|141459208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0224|TWO_SIDED|95.0|-1.01|-0.08|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Social life-Week 14||-0.08|-1.01|0.0224
70975806|NCT01360645|141459208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.0146|TWO_SIDED|95.0|-1.01|-0.11|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Family life-Week 11||-0.11|-1.01|0.0146
70975807|NCT01360645|141459208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.0113|TWO_SIDED|95.0|-1.09|-0.14|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Family life-Week 14||-0.14|-1.09|0.0113
70975808|NCT01360645|141459209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.34||||0.0001|TWO_SIDED|95.0|-3.47|-1.22|||ANCOVA|||ANCOVA\_Last observation carry forward (LOCF) model with treatment and trial site as main effects, and baseline (end of Phase A \[Week 8\]) value as a covariate was used.||-1.22|-3.47|0.0001
70975809|NCT01360645|141459210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.29||||0.0002|TWO_SIDED|95.0|-3.47|-1.12|||ANCOVA|||||-1.12|-3.47|0.0002
70975810|NCT01360645|141459211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17||||0.0219|TWO_SIDED|95.0|-2.17|-0.17|||ANCOVA|||ANCOVA\_LOCF model with treatment and trial site as main effects, and baseline (end of Phase A \[Week 8\]) value as a covariate was used.||-0.17|-2.17|0.0219
70975811|NCT01360645|141459212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09||||0.0376|TWO_SIDED|95.0|-2.13|-0.06|||ANCOVA|||||-0.06|-2.13|0.0376
70975812|NCT01360645|141459213|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.63||||0.0176|TWO_SIDED|95.0|1.09|2.44|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.||||2.44|1.09|0.0176
70975813|NCT01360645|141459214|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.54||||0.0429|TWO_SIDED|95.0|1.01|2.35|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.||||2.35|1.01|0.0429
70975814|NCT01360645|141459215|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.68||||0.0586|TWO_SIDED|95.0|0.98|2.86|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.||||2.86|0.98|0.0586
70975815|NCT01360645|141459216|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.67||||0.0671|TWO_SIDED|95.0|0.97|2.9|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.||||2.90|0.97|0.0671
70975816|NCT01360645|141459217|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.61||||0.0003|TWO_SIDED|95.0|1.23|2.1|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.||||2.10|1.23|0.0003
70975817|NCT01360645|141459218|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.69||||0.0002|TWO_SIDED|95.0|1.27|2.27|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.||||2.27|1.27|0.0002
70975818|NCT01014585|141459219|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.44||||0.0004|TWO_SIDED|95.0|0.27|0.71|||Log Rank|||||0.71|0.27|0.0004
70975819|NCT01014585|141459219|SUPERIORITY_OR_OTHER||Days until LTR at the 25th percentile|18.0||||||95.0||||||||||||
70975820|NCT01014585|141459219|SUPERIORITY_OR_OTHER||Days until LTR at the 25th percentile|45.0||||||95.0||||||||||||
70975821|NCT01014585|141459220|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36||||0.0002|TWO_SIDED|95.0|0.2|0.63|||Log Rank|||||0.63|0.20|0.0002
70975822|NCT01014585|141459220|SUPERIORITY_OR_OTHER||Days until LTR at the 25th percentile|22.0||||||95.0||||||||||||
70975823|NCT01014585|141459221|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.4104|TWO_SIDED|95.0|0.46|1.38|||Log Rank|||||1.38|0.46|0.4104
70975824|NCT01014585|141459221|SUPERIORITY_OR_OTHER||Days until LTR at the 25th percentile|18.0||||||95.0||||||||||||
70975825|NCT01014585|141459221|SUPERIORITY_OR_OTHER||Days until LTR at the 25th percentile|30.0||||||95.0||||||||||||
70975826|NCT00773279|141459240|NON_INFERIORITY_OR_EQUIVALENCE|"A two-sided 95 % Confidence Interval (CI) for the treatment difference, PDS290 minus FlexPen, in HbA1c after 12 weeks of treatment. PDS290 was to be declared non-inferior to FlexPen® if the upper limit of that CI would be less than the non-inferiority margin 0.40 % (absolute)."|Mean Difference (Final Values)|-0.047|STANDARD_ERROR_OF_MEAN|0.04||||95.0|-0.127|0.032|||Linear mixed effect model|Linear mixed effect model with period and delivery systems as fixed effects, and subject as a random effect.||The null hypothesis is that PDS290 be not non-inferior to FlexPen® with respect to HbA1c after 12 weeks of treatment; non-inferiority margin is 0.4 % (absolute).||0.032|-0.127|
70975827|NCT00508391|141459255|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority hypothesis utilized an objective performance criteria of 63% with a clinically significant difference of 12%. For the non-inferiority hypothesis, the one-sided Type I error was set to 0.05 and the statistical power was set to 80%.|Objective Performance Criteria|63.0|||||ONE_SIDED|95.0|54.8||||Non-inferiority comparison|||"Efficacy was assessed in a non-inferiority, responder classification design where the proportion of total subjects classified as not worsened after changing from optimized to simultaneous biventricular pacing was compared to an objective performance criteria.~An effect of gender analysis was performed on the primary efficacy endpoint to compare the proportion of males and females classified as not worsened after changing from optimized to simultaneous biventricular pacing."|||54.8|
70975828|NCT00508391|141459256|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority hypothesis has a one-sided Type I error of 0.05 with an 80% statistical power.|Objective Performance Criteria|100.0|||||ONE_SIDED|95.0|97.6||||Non-inferiority comparison|||Safety will be evaluated in a non-inferiority format. The null hypothesis is the percent of subjects that did not experience an adverse event with an active interventricular delay feature at two months is inferior to 90% with a clinically significant difference of 10%|||97.6|
70975829|NCT01225562|141459270|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.008|TWO_SIDED|95.0|0.75|0.96|||Regression, Cox||The hazard ratio shows ticagrelor 90 mg hazard / placebo hazard|||0.96|0.75|0.0080
70975830|NCT01225562|141459270|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0043|TWO_SIDED|95.0|0.74|0.95|||Regression, Cox||The hazard ratio shows ticagrelor 60 mg hazard / placebo hazard|||0.95|0.74|0.0043
70975831|NCT01225562|141459271|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.1547|TWO_SIDED|95.0|0.71|1.06|||Regression, Cox||The hazard ratio shows ticagrelor 90 mg hazard / placebo hazard|||1.06|0.71|0.1547
70975832|NCT01225562|141459271|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0676|TWO_SIDED|95.0|0.68|1.01|||Regression, Cox||The hazard ratio shows ticagrelor 60 mg hazard / placebo hazard|||1.01|0.68|0.0676
70975833|NCT01225562|141459272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9851|TWO_SIDED|95.0|0.86|1.16|||Regression, Cox||The hazard ratio shows ticagrelor 90 mg hazard / placebo hazard|||1.16|0.86|0.9851
70975834|NCT01225562|141459272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.135|TWO_SIDED|95.0|0.76|1.04|||Regression, Cox||The hazard ratio shows ticagrelor 60 mg hazard / placebo hazard|||1.04|0.76|0.1350
70975835|NCT01225562|141459273|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.69|||<|0.0001|TWO_SIDED|95.0|1.96|3.7|||Regression, Cox||The hazard ratio shows ticagrelor 90 mg hazard / placebo hazard|||3.70|1.96|<0.0001
70975836|NCT01225562|141459273|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.32|||<|0.0001|TWO_SIDED|95.0|1.68|3.21|||Regression, Cox||The hazard ratio shows ticagrelor 60 mg hazard / placebo hazard|||3.21|1.68|<0.0001
70975837|NCT00565617|141459293|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED||||||ANOVA|||||||0.009
70975838|NCT01446419|141459305|SUPERIORITY_OR_OTHER|||||||0.019|||||||ANCOVA|P-value from ANCOVA with factors of tx group, analysis center and tx group by analysis center interaction, and a covariate of baseline ODI score.||||||0.019
70975839|NCT01228903|141459325|EQUIVALENCE|(Doehner et al.) CHF patients on allopurinol (n= 14) had improved BA-FMD= 10.6 ± 2.0 (mean ± SE) vs placebo (n= 14, FMD= 6.7 ± 0.1); difference in means= 3.9. Yiginer et al. found a similar difference in metabolic syndrome. A sample size of 34/group will have 80% power to detect a difference in means of 3.9 (common standard deviation=5.6, two group t-test=0.050 two-sided significance). Accounting for a potential drop-out rate17%, n= 40/group was recruited.|Mean Difference (Net)|0.7||||0.47|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The estimated value represents the difference between the change from baseline in both groups.|The null hypothesis was the there will be no difference between the placebo and allopurinol. The power for the study was calculated (as appropriate) based on the prior literature.||||0.47
70975840|NCT01557166|141459331|SUPERIORITY_OR_OTHER||Estimated treatment difference|-6.1||||0.015||95.0|-11.0|-1.19|||ANCOVA|ANCOVA model was used with treatment, country and sex as fixed factors, and the baseline value of AHI, baseline BMI and baseline age as covariates.||Let μ liraglutide 3.0mg and μ placebo denote mean change in AHI for liraglutide 3.0 mg and placebo,respectively. The null-hypothesis and the alternative was H0: μliraglutide 3.0mg = μplacebo against the alternative HA: μliraglutide 3.0mg ≠ μplacebo.||-1.19|-11.0|0.015
71008482|NCT02355665|141524890|SUPERIORITY||Estimated Success Rate Ratio|2.91||||0.006|TWO_SIDED|95.0|1.32|6.42||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||6.42|1.32|0.006
71034108|NCT03043872|141577805|OTHER||Hazard Ratio (HR)|0.65||||0.0664|TWO_SIDED|95.0|0.414|1.029||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + EP vs EP. HR \<1 favors D + EP to be associated with a longer OS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||1.029|0.414|0.0664
70975841|NCT02986230|141459335|SUPERIORITY||Odds Ratio (OR)|1.07||||0.025|TWO_SIDED|||||Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant, and odds ratios for key study group contrasts report 97.5% confidence intervals.|Mixed Models Analysis|Denominator degrees of freedom for variables in the model take into account the cluster-randomized design.||Generalized linear mixed models with logit link and binomial error distribution were used to test the effect of the intervention on the composite of cancer screening by 1 year post-index for breast, cervical, and colorectal cancer. The model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in the randomization process. Tests of the two contrasts were 2-sided with P-values \< 0.025 considered statistically significant.||||.025
70975842|NCT02986230|141459335|SUPERIORITY||Odds Ratio (OR)|0.91||||0.025|TWO_SIDED|||||Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant, and odds ratios for key study group contrasts report 97.5% confidence intervals.|Mixed Models Analysis|Denominator degrees of freedom for variables in the model take into account the cluster-randomized design.||Generalized linear mixed models with a logit link and binomial error distribution were used to test the effect of the intervention on the composite of cancer screening by 1 year post-index date for breast, cervical, and colorectal cancer. Model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in randomization process. Tests of the planned contrasts were 2-sided with P-values \< 0.025 considered statistically significant.||||.025
70975843|NCT02986230|141459336|SUPERIORITY||Odds Ratio (OR)|1.04||||0.025|TWO_SIDED|||||Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant, and odds ratios for key study group contrasts report 97.5% confidence intervals.|Mixed Models Analysis|Denominator degrees of freedom for variables in the model take into account the cluster-randomized design.||Generalized linear mixed models with a logit link and binomial error distribution were used to test the effect of the intervention on completion of the HPV vaccination series by 12 months post-index date. The model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in the randomization process. Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant.||||.025
70975844|NCT02986230|141459336|SUPERIORITY||Odds Ratio (OR)|0.71||||0.025|TWO_SIDED|||||Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant, and odds ratios for key study group contrasts report 97.5% confidence intervals.|Mixed Models Analysis|Denominator degrees of freedom for variables in the model take into account the cluster-randomized design.||Generalized linear mixed models with a logit link and binomial error distribution were used to test the effect of the intervention on completion of the HPV vaccination series by 12 months post-index date. The model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in the randomization process. Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant.||||.025
70975845|NCT02986230|141459337|SUPERIORITY||Odds Ratio (OR)|1.55||||0.025|TWO_SIDED|||||Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant, and odds ratios for key study group contrasts report 97.5% confidence intervals.|Mixed Models Analysis|Denominator degrees of freedom for variables in the model take into account the cluster-randomized design.||Generalized linear mixed models with a logit link and binomial error distribution were used to test the effect of the intervention on completion of lung cancer screening by 12 months post-index date. The model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in the randomization process. Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant.||||.025
70975846|NCT02986230|141459337|SUPERIORITY||Odds Ratio (OR)|1.02||||0.025|TWO_SIDED|||||Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant, and odds ratios for key study group contrasts report 97.5% confidence intervals.|Mixed Models Analysis|Denominator degrees of freedom for variables in the model take into account the cluster-randomized design.||Generalized linear mixed models with a logit link and binomial error distribution were used to test the intervention effect on the completion of lung cancer screening by 12 months post-index. The model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in the randomization process. Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant.||||.025
70975847|NCT00954109|141459406|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
70975848|NCT00954109|141459407|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
70975849|NCT01445678|141459415|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower bound of the 2-sided 95% confidence interval was greater than -10%.|Risk Difference (RD)|-4.2|||||TWO_SIDED|95.0|-8.91|0.54||||||||0.54|-8.91|
70975850|NCT01445678|141459416|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower bound of the 2-sided 95% confidence interval was greater than -10%.|Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-4.52|2.59||||||||2.59|-4.52|
70975851|NCT01445678|141459417|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.1|||||TWO_SIDED|95.0|-7.23|0.89||||||||0.89|-7.23|
70975852|NCT01445678|141459418|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.4|||||TWO_SIDED|95.0|-3.4|2.33||||||||2.33|-3.4|
70975853|NCT01445678|141459419|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.1|||||TWO_SIDED|95.0|-9.09|0.94||||||||0.94|-9.09|
70975854|NCT01445678|141459420|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.7|||||TWO_SIDED|95.0|-0.88|2.37||||||||2.37|-0.88|
70975855|NCT03988907|141459464|OTHER|Descriptive statistics. A sample size of 26 evaluable participants ensures that the two-sided 90% confidence interval for the geometric population mean of the individual exposure ratios of Day 16 to Day 1 will lie within the 0.75 to 1.33 limits of the geometric population mean with at least 80% probability (power).|Ratio of Geometric Least Squares Means|1.08|||||TWO_SIDED|90.0|0.93|1.26||||||||1.26|0.93|
70975856|NCT03988907|141459465|OTHER|Descriptive statistics. A sample size of 26 evaluable participants ensures that the two-sided 90% confidence interval for the geometric population mean of the individual exposure ratios of Day 16 to Day 1 will lie within the 0.75 to 1.33 limits of the geometric population mean with at least 80% probability (power).|Ratio of Geometric Least Squares Means|1.11|||||TWO_SIDED|90.0|1.02|1.2||||||||1.20|1.02|
70975857|NCT03988907|141459466|OTHER|Descriptive statistics. A sample size of 26 evaluable participants ensures that the two-sided 90% confidence interval for the geometric population mean of the individual exposure ratios of Day 16 to Day 1 will lie within the 0.75 to 1.33 limits of the geometric population mean with at least 80% probability (power).|Ratio of Geometric Least Squares Means|1.16|||||TWO_SIDED|90.0|1.06|1.28||||||||1.28|1.06|
70922098|NCT03363854|141334534|SUPERIORITY||Difference|0.0||||1|TWO_SIDED|95.0|-11.0|11.0||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 1-2 are reported below.||11.0|-11.0|1.00
70922099|NCT03363854|141334534|SUPERIORITY||Difference|1.1||||0.83|TWO_SIDED|95.0|-9.1|11.4||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 3-4 are reported below.||11.4|-9.1|0.83
70922100|NCT03363854|141334534|SUPERIORITY||Difference|-1.4||||0.78|TWO_SIDED|95.0|-11.3|8.5||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 5-6 are reported below.||8.5|-11.3|0.78
70922101|NCT03363854|141334534|SUPERIORITY||Difference|-4.8||||0.34|TWO_SIDED|95.0|-14.8|5.1||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 7-8 are reported below.||5.1|-14.8|0.34
70922102|NCT03363854|141334534|SUPERIORITY||Difference|-4.4||||0.34|TWO_SIDED|95.0|-13.4|4.6||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 9-10 are reported below.||4.6|-13.4|0.34
70922103|NCT03363854|141334534|SUPERIORITY||Difference|-6.2||||0.11|TWO_SIDED|95.0|-13.9|1.5||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 11-12 are reported below.||1.5|-13.9|0.11
70922104|NCT03363854|141334534|SUPERIORITY||Difference|-8.9||||0.024|TWO_SIDED|95.0|-16.6|-1.2||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 13-14 are reported below.||-1.2|-16.6|0.024
70922105|NCT03363854|141334534|SUPERIORITY||Difference|-9.5||||0.017|TWO_SIDED|95.0|-17.3|-1.7||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 15-16 are reported below.||-1.7|-17.3|0.017
70922106|NCT03363854|141334536|SUPERIORITY||Difference|0.1||||0.64|TWO_SIDED|95.0|-0.5|0.7||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 1 are reported below.||0.7|-0.5|0.64
70922107|NCT03363854|141334536|SUPERIORITY||Difference|0.4||||0.26|TWO_SIDED|95.0|-0.3|1.0||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 2 are reported below.||1.0|-0.3|0.26
70922108|NCT03363854|141334536|SUPERIORITY||Difference|0.2||||0.46|TWO_SIDED|95.0|-0.4|0.8||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 3 are reported below.||0.8|-0.4|0.46
70922109|NCT03363854|141334536|SUPERIORITY||Difference|0.4||||0.16|TWO_SIDED|95.0|-0.2|1.0||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 4 are reported below.||1.0|-0.2|0.16
70922110|NCT03363854|141334536|SUPERIORITY||Difference|0.5||||0.13|TWO_SIDED|95.0|-0.1|1.1||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 5 are reported below.||1.1|-0.1|0.13
70975858|NCT03988907|141459467|OTHER|Descriptive statistics. A sample size of 26 evaluable participants ensures that the two-sided 90% confidence interval for the geometric population mean of the individual exposure ratios of Day 16 to Day 1 will lie within the 0.75 to 1.33 limits of the geometric population mean with at least 80% probability (power).|Ratio of Geometric Least Squares Means|1.12|||||TWO_SIDED|90.0|0.99|1.27||||||||1.27|0.99|
70975859|NCT03988907|141459468|OTHER|Descriptive statistics. A sample size of 26 evaluable participants ensures that the two-sided 90% confidence interval for the geometric population mean of the individual exposure ratios of Day 16 to Day 1 will lie within the 0.75 to 1.33 limits of the geometric population mean with at least 80% probability (power).|Ratio of Geometric Least Squares Means|1.2|||||TWO_SIDED|90.0|1.11|1.3||||||||1.30|1.11|
70975860|NCT03988907|141459469|OTHER|Descriptive statistics. A sample size of 26 evaluable participants ensures that the two-sided 90% confidence interval for the geometric population mean of the individual exposure ratios of Day 16 to Day 1 will lie within the 0.75 to 1.33 limits of the geometric population mean with at least 80% probability (power).|Ratio of Geometric Least Squares Means|1.27|||||TWO_SIDED|90.0|1.14|1.41||||||||1.41|1.14|
70975861|NCT03932799|141459492|SUPERIORITY|Adjusted for workers' compensation-based covariates: age, gender, urban/rural residence, coronavirus disease (COVID)-19 era injury, days from injury to Report of Accident, injury type, injury complexity/severity, days from injury to first opioid prescription, more than 7 days of opioids in acute phase, and health care utilization during baseline period/acute phase.|Odds Ratio (OR)|0.25|||<|0.001|TWO_SIDED|95.0|0.16|0.38||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Robust variance estimates"||0.38|0.16|<.001
70975862|NCT03932799|141459493|SUPERIORITY|Adjusted for workers' compensation-based covariates: age, gender, urban/rural residence, COVID-19 era injury, days from injury to Report of Accident, injury type, injury complexity/severity, days from injury to first opioid prescription, more than 7 days of opioids in acute phase, health care utilization during baseline period/acute phase, and time indicator for each time period (0,1,2).|Odds Ratio (OR)|0.83||||0.43|TWO_SIDED|95.0|0.53|1.31||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Generalized estimating equation|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Outcome modeled longitudinally over the 3 time periods (3-6, 6-9, and 9-12 months)~* Time periods clustered at the individual worker level~* Exchangeable working correlation structure~* Robust variance estimates"||1.31|0.53|.43
70975863|NCT03932799|141459496|SUPERIORITY|Adjusted for workers' compensation-based covariates: age, gender, urban/rural residence, COVID-19 era injury, days from injury to Report of Accident, injury type, injury complexity/severity, days from injury to first opioid prescription, more than 7 days of opioids in acute phase, health care utilization during baseline period/acute phase, and time indicator for each time period (0,1,2).|Odds Ratio (OR)|3.04||||0.002|TWO_SIDED|95.0|1.5|6.14||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Generalized estimating equation|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Outcome modeled longitudinally over the 3 time periods (3-6, 6-9, and 9-12 months)~* Time periods clustered at the individual worker level~* Exchangeable working correlation structure~* Robust variance estimates"||6.14|1.50|.002
70975864|NCT03932799|141459497|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey covariates: days from injury to baseline survey, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and physical therapy (PT) utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, quality of life.|Odds Ratio (OR)|0.97||||0.84|TWO_SIDED|95.0|0.71|1.32||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.32|0.71|.84
70975865|NCT03932799|141459498|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.03||||0.88|TWO_SIDED|95.0|0.71|1.49||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.49|0.71|.88
70975866|NCT03932799|141459499|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|0.74||||0.15|TWO_SIDED|95.0|0.49|1.11||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.11|0.49|.15
70975867|NCT03932799|141459500|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|0.85||||0.38|TWO_SIDED|95.0|0.6|1.21||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.21|0.60|.38
70975868|NCT03932799|141459501|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.44||||0.12|TWO_SIDED|95.0|0.91|2.28||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Leisure or social activities outcome~* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||2.28|0.91|.12
71008483|NCT02355665|141524891|SUPERIORITY||Estimated Success Rate Ratio|2.66||||0.013|TWO_SIDED|95.0|1.2|5.92||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||5.92|1.20|0.013
71095718|NCT02762604|141699849|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-0.45|0.9|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in maze errors pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||0.90|-0.45|
71095719|NCT02762604|141699850|SUPERIORITY||Mean Difference (Net)|0.26|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|95.0|-1.74|2.26|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in depressive symptoms pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||2.26|-1.74|
71095720|NCT02762604|141699851|SUPERIORITY||Mean Difference (Net)|-0.95|STANDARD_ERROR_OF_MEAN|1.24|||TWO_SIDED|95.0|-3.38|1.49|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in anxiety symptoms pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||1.49|-3.38|
70975869|NCT03932799|141459501|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.23||||0.42|TWO_SIDED|95.0|0.74|2.07||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Getting out with friends or family outcome~* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||2.07|0.74|.42
70975870|NCT03932799|141459501|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|0.98||||0.91|TWO_SIDED|95.0|0.63|1.51||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Doing household chores outcome~* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.51|0.63|.91
70975871|NCT03932799|141459501|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.19||||0.59|TWO_SIDED|95.0|0.64|2.21||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Using transportation outcome~* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||2.21|0.64|.59
71008484|NCT02355665|141524892|SUPERIORITY||Estimated Mean Difference|-0.02||||0.847|TWO_SIDED|95.0|-0.64|0.6||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of desire/urge to smoke between treatments. The alternative hypothesis was a difference in distribution of the ratings of desire/urge to smoke between treatments.||0.60|-0.64|0.847
71008485|NCT02355665|141524893|SUPERIORITY||Estimated Mean Difference|-0.1||||0.861|TWO_SIDED|95.0|-0.62|0.42||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of desire/urge to smoke between treatments. The alternative hypothesis was a difference in distribution of the ratings of desire/urge to smoke between treatments.||0.42|-0.62|0.861
71008486|NCT02355665|141524894|SUPERIORITY||Estimated Mean Difference|-0.19||||0.266|TWO_SIDED|95.0|-0.61|0.24||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of desire/urge to smoke between treatments. The alternative hypothesis was a difference in distribution of the ratings of desire/urge to smoke between treatments.||0.24|-0.61|0.266
71008487|NCT02355665|141524895|SUPERIORITY||Estimated Mean Difference|0.09||||0.487|TWO_SIDED|95.0|-0.38|0.55||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of desire/urge to smoke between treatments. The alternative hypothesis was a difference in distribution of the ratings of desire/urge to smoke between treatments.||0.55|-0.38|0.487
71008488|NCT02355665|141524896|SUPERIORITY||Estimated Mean Difference|-0.11||||0.433|TWO_SIDED|95.0|-0.65|0.43||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of irritability/frustration/anger between treatments. The alternative hypothesis was a difference in distribution of the ratings of irritability/frustration/anger between treatments.||0.43|-0.65|0.433
71008489|NCT02355665|141524897|SUPERIORITY||Estimated Mean Difference|-0.58||||0.022|TWO_SIDED|95.0|-1.15|-0.01||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of irritability/frustration/anger between treatments. The alternative hypothesis was a difference in distribution of the ratings of irritability/frustration/anger between treatments.||-0.01|-1.15|0.022
71008490|NCT02355665|141524898|SUPERIORITY||Estimated Mean Difference|0.0||||0.665|TWO_SIDED|95.0|-0.5|0.49||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of irritability/frustration/anger between treatments. The alternative hypothesis was a difference in distribution of the ratings of irritability/frustration/anger between treatments.||0.49|-0.50|0.665
70922111|NCT03363854|141334536|SUPERIORITY||Difference|0.3||||0.38|TWO_SIDED|95.0|-0.3|0.9||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 6 are reported below.||0.9|-0.3|0.38
70922112|NCT03363854|141334536|SUPERIORITY||Difference|0.6||||0.04|TWO_SIDED|95.0|0.0|1.2||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 7 are reported below.||1.2|0.0|0.040
70922113|NCT03363854|141334536|SUPERIORITY||Difference|0.3||||0.31|TWO_SIDED|95.0|-0.3|1.0||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 8 are reported below.||1.0|-0.3|0.31
70922114|NCT03363854|141334536|SUPERIORITY||Difference|1.0||||0.001|TWO_SIDED|95.0|0.4|1.6||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 9 are reported below.||1.6|0.4|0.001
70922115|NCT03363854|141334536|SUPERIORITY||Difference|0.7||||0.026|TWO_SIDED|95.0|0.1|1.3||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 10 are reported below.||1.3|0.1|0.026
70922116|NCT03363854|141334536|SUPERIORITY||Difference|0.9||||0.006|TWO_SIDED|95.0|0.2|1.5||The statistical test was not controlled for multiplicity.|Repeated measurements model]|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 11 are reported below.||1.5|0.2|0.006
70922117|NCT03363854|141334536|SUPERIORITY||Difference|0.6||||0.043|TWO_SIDED|95.0|0.0|1.3||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 12 are reported below.||1.3|0.0|0.043
70922118|NCT03363854|141334536|SUPERIORITY||Difference|0.8||||0.01|TWO_SIDED|95.0|0.2|1.4||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 13 are reported below.||1.4|0.2|0.010
70922119|NCT03363854|141334536|SUPERIORITY||Difference|0.7||||0.037|TWO_SIDED|95.0|0.0|1.3||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 14 are reported below.||1.3|0.0|0.037
70922120|NCT03363854|141334536|SUPERIORITY||Difference|0.6||||0.045|TWO_SIDED|95.0|0.0|1.3||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 15 are reported below.||1.3|0.0|0.045
70922121|NCT03363854|141334536|SUPERIORITY||Difference|0.5||||0.17|TWO_SIDED|95.0|-0.2|1.1||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 16 are reported below.||1.1|-0.2|0.17
70922122|NCT03363854|141334537|SUPERIORITY||Risk Difference (RD)|21.3|||<|0.001|TWO_SIDED|95.0|11.3|31.3||The statistical test was not controlled for multiplicity.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their EASI value at Week 16.||31.3|11.3|<0.001
70922123|NCT03363854|141334538|SUPERIORITY||Risk Difference (RD)|11.4||||0.022|TWO_SIDED|95.0|2.1|20.7||The statistical test was not controlled for multiplicity.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their EASI value at Week 16.||20.7|2.1|0.022
70922124|NCT03363854|141334539|SUPERIORITY||Difference|-5.4|||<|0.001|TWO_SIDED|95.0|-7.7|-3.1||The statistical test was not controlled for multiplicity.|Repeated measurement model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.||-3.1|-7.7|<0.001
70922125|NCT03363854|141334540|SUPERIORITY||Risk Difference (RD)|22.9|||<|0.001|TWO_SIDED|95.0|12.4|33.3||The statistical test was not controlled for multiplicity.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Partcipants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their SCORAD value at Week 16.||33.3|12.4|<0.001
70922126|NCT03363854|141334541|SUPERIORITY||Risk Difference (RD)|11.1||||0.012|TWO_SIDED|95.0|3.2|19.0||The statistical test was not controlled for multiplicity.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their SCORAD value at Week 16.||19.0|3.2|0.012
70922127|NCT03363854|141334542|SUPERIORITY||Difference|-1.2|||<|0.001|TWO_SIDED|95.0|-1.7|-0.7||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.||-0.7|-1.7|<0.001
70975872|NCT03932799|141459502|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.24||||0.22|TWO_SIDED|95.0|0.88|1.75||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.75|0.88|.22
70975873|NCT03932799|141459503|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.97||||0.02|TWO_SIDED|95.0|1.12|3.47||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||3.47|1.12|.02
70975874|NCT03932799|141459504|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.32||||0.1|TWO_SIDED|95.0|0.95|1.83||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.83|0.95|.10
70975875|NCT03932799|141459506|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|beta|-0.01||||0.53|TWO_SIDED|95.0|-0.03|0.01||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||0.01|-0.03|.53
70975876|NCT03932799|141459507|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|beta|0.16||||0.053|TWO_SIDED|95.0|0.0|0.32||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||0.32|-0.00|.053
70975877|NCT03932799|141459508|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|beta|0.22||||0.01|TWO_SIDED|95.0|0.05|0.38||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||0.38|0.05|.01
71034109|NCT03043872|141577806|OTHER||Hazard Ratio (HR)|0.75||||0.1455|TWO_SIDED|95.0|0.504|1.106||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + EP vs EP. HR \<1 favors D + EP to be associated with a longer OS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||1.106|0.504|0.1455
71034110|NCT03043872|141577806|OTHER||Hazard Ratio (HR)|0.65||||0.0314|TWO_SIDED|95.0|0.439|0.964||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs EP. HR \<1 favors D + T + EP to be associated with a longer OS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||0.964|0.439|0.0314
71034111|NCT03043872|141577807|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.4352|TWO_SIDED|95.0|0.89|1.309||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs D + EP. HR \<1 favors D + T + EP to be associated with a longer OS than D + EP.||1.309|0.890|0.4352
70975878|NCT03932799|141459509|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|0.76||||0.35|TWO_SIDED|95.0|0.42|1.35||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.35|0.42|.35
70975879|NCT01307033|141459522|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares means|0.2|||||TWO_SIDED|95.0|-1.7|2.2|||Constained logitudinal data analysis|Model included treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups||||2.2|-1.7|
70975880|NCT01307033|141459523|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares means|-2.3|||||TWO_SIDED|95.0|-5.0|0.5|||Constained longitudinal data analysis|Model included treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups||||0.5|-5.0|
70975881|NCT00947531|141459533|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.17|||<|0.0001|TWO_SIDED|95.0|-8.22|-4.13||P-value obtained from the F-test statistic of Cerebrolysin versus Placebo as part of ANCOVA (analysis of covariance). No adjustment for multiple comparisons was needed. The overall significance level alpha was fixed at alpha = 0.05 (two-sided).|ANCOVA|The study was designed to show significant differences in each of the two primary variables. No adjustment for multiple comparisons was needed.||The null-hypothesis stated no difference between the two treatment groups. A sample size of 103 evaluable patients per treatment group was estimated to allow for the detection of a significant group difference of 4.1 points in ADAS-cog+ weak 24 change score (standard deviation \[SD\] 9.0) in favor of Cerebrolysin with a power of 90% and a probability level of alpha-level 0.025 (one-sided).||-4.13|-8.22|< 0.0001
70975882|NCT01773421|141459563|EQUIVALENCE|Log-transformed pharmacokinetic parameters were fit using a mixed effects model with sequence, treatment, period and sequence as fixed effects and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed to obtain the treatment estimates.|Geometric Least Square (LS) Mean Ratio|1.06|||||TWO_SIDED|90.0|0.97|1.15||||||||1.15|0.97|
70975883|NCT01773421|141459564|EQUIVALENCE|Log-transformed pharmacokinetic parameters were fit using a mixed effects model with sequence, treatment, period and sequence as fixed effects and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed to obtain the treatment estimates.|Geometric LS Mean Ratio|1.11|||||TWO_SIDED|90.0|1.02|1.2||||||||1.2|1.02|
70975884|NCT01773421|141459565|EQUIVALENCE|Log-transformed pharmacokinetic parameters were fit using a mixed effects model with sequence, treatment, period and sequence as fixed effects and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed to obtain the treatment estimates.|Geometric LS Mean Ratio|1.13|||||TWO_SIDED|90.0|1.0|1.27||||||||1.27|1|
70975885|NCT02804763|141459571|SUPERIORITY||||||=|0.0727||||||The lowest p-value (z-statistic with the highest value) was used to establish proof of dose response.|MCP-Mod|||"Multiple contrast testing (MCP-mod methodology) was used to test for a statistically significant dose-response relationship between the primary endpoint (BICLA at Week 24) and dose, which would indicate a drug effect of DZP over Placebo.~The best fitting statistically significant model could be used to estimate the dose needed to achieve desired treatment effect."||||=0.0727
70975886|NCT02804763|141459572|SUPERIORITY||Odds Ratio (OR)|1.6|||=|0.2699|TWO_SIDED|95.0|0.7|3.8||Generalized linear models with factors for treatment and corticosteroid strata were fit using a logit link function for the odds ratios and p-values.|Chi-squared|||Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||3.8|0.7|=0.2699
71008491|NCT02355665|141524899|SUPERIORITY||Estimated Mean Difference|-0.1||||0.3|TWO_SIDED|95.0|-0.51|0.31||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of irritability/frustration/anger between treatments. The alternative hypothesis was a difference in distribution of the ratings of irritability/frustration/anger between treatments.||0.31|-0.51|0.300
71008492|NCT02355665|141524900|SUPERIORITY||Estimated Mean Difference|-0.17||||0.754|TWO_SIDED|95.0|-0.78|0.43||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of restlessness between treatments. The alternative hypothesis was a difference in distribution of the ratings of restlessness between treatments.||0.43|-0.78|0.754
71008493|NCT02355665|141524901|SUPERIORITY||Estimated Mean Difference|-0.41||||0.116|TWO_SIDED|95.0|-0.89|0.08||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of restlessness between treatments. The alternative hypothesis was a difference in distribution of the ratings of restlessness between treatments.||0.08|-0.89|0.116
70975887|NCT02804763|141459572|SUPERIORITY||Odds Ratio (OR)|2.0|||=|0.1036|TWO_SIDED|95.0|0.9|4.8||Generalized linear models with factors for treatment and corticosteroid strata were fit using a logit link function for the odds ratios and p-values.|Chi-squared|||Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||4.8|0.9|=0.1036
70975888|NCT02804763|141459572|SUPERIORITY||Odds Ratio (OR)|1.9|||=|0.1518|TWO_SIDED|95.0|0.8|4.3||Generalized linear models with factors for treatment and corticosteroid strata were fit using a logit link function for the odds ratios and p-values.|Chi-squared|||Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||4.3|0.8|=0.1518
70975889|NCT02804763|141459572|SUPERIORITY||Difference vs PBO|11.6|||||TWO_SIDED|95.0|-9.2|32.4||Crude difference in proportion responding and standard Wald asymptotic 95 % CI based on the normal approximation to the binomial distribution.|Chi-squared||Difference and 95 % Wald CI in proportion of responders for SOC + DZP dose 1 iv Q4W (FAS) versus SOC + Placebo iv Q4W (FAS).|Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||32.4|-9.2|
70975890|NCT02804763|141459572|SUPERIORITY||Difference vs PBO|17.3|||||TWO_SIDED|95.0|-3.3|38.0||Crude difference in proportion responding and standard Wald asymptotic 95 % CI based on the normal approximation to the binomial distribution.|Chi-squared||Difference and 95 % Wald CI in proportion of responders for SOC + DZP dose 2 iv Q4W (FAS) versus SOC + Placebo iv Q4W (FAS).|Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||38.0|-3.3|
70975891|NCT02804763|141459572|SUPERIORITY||Difference vs PBO|15.0|||||TWO_SIDED|95.0|-5.5|35.4||Crude difference in proportion responding and standard Wald asymptotic 95 % CI based on the normal approximation to the binomial distribution.|Chi-squared||Difference and 95 % Wald CI in proportion of responders for SOC + DZP dose 3 iv Q4W (FAS) versus SOC + Placebo iv Q4W (FAS).|Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||35.4|-5.5|
70975892|NCT02804763|141459572|SUPERIORITY||LS Mean Difference vs PBO|11.9|||||TWO_SIDED|95.0|-8.7|32.5||Generalized linear models with factors for treatment and corticosteroid strata were fit using an identity link function for the LS mean differences.|Chi-squared|||Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||32.5|-8.7|
70975893|NCT02804763|141459572|SUPERIORITY||LS Mean Difference vs PBO|17.6|||||TWO_SIDED|95.0|-3.2|38.3||Generalized linear models with factors for treatment and corticosteroid strata were fit using an identity link function for the LS mean differences.|Chi-squared|||Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||38.3|-3.2|
70975894|NCT02804763|141459572|SUPERIORITY||LS Mean Difference vs PBO|15.2|||||TWO_SIDED|95.0|-5.2|35.6||Generalized linear models with factors for treatment and corticosteroid strata were fit using an identity link function for the LS mean differences.|Chi-squared|||Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||35.6|-5.2|
70975895|NCT04656990|141459630|SUPERIORITY||Slope|17.1|||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
70975896|NCT04656990|141459633|SUPERIORITY||Slope|3.4|||=|0.04|TWO_SIDED||||||Mixed Models Analysis|||||||=0.04
70975897|NCT03657459|141459658|SUPERIORITY|||||||0.0096|||||||Chi-squared|Pearsons Chi Square||||||0.0096
70975898|NCT03657459|141459659|SUPERIORITY|||||||0.9||||||no adjustment|Chi-squared|Pearson Chi-square||||||0.90
70975899|NCT00282243|141459666|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of the natural log-transformed pharmacokinetic parameters fell within an 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|88.79|||||TWO_SIDED|90.0|85.42|92.29|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance with repeated measures was used for the comparisons of AUC0-24. Exposure at steady state was used for tacrolimus (steady state was defined as days 14 and 42) and for tacrolimus MR (steady state was defined as days 28 and 56). The natural log (ln) was used to transform AUC0-24 prior to analysis and the results were transformed back to the original scale for the presentation of results.||92.29|85.42|
70975900|NCT00282243|141459668|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of the natural log-transformed pharmacokinetic parameters fell within an 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|81.4|||||TWO_SIDED|90.0|77.88|85.08|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance with repeated measures was used for the comparisons of Cmin. Exposure at steady state was used for tacrolimus (steady state was defined as days 14 and 42) and for tacrolimus MR (steady state was defined as days 28 and 56). The natural log (ln) was used to transform Cmin prior to analysis and the results were transformed back to the original scale for the presentation of results.||85.08|77.88|
71034112|NCT03043872|141577808|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0157|TWO_SIDED|95.0|0.665|0.959||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + EP vs EP. HR \<1 favors D + EP to be associated with a longer PFS than EP.||0.959|0.665|0.0157
71034113|NCT03043872|141577808|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0568|TWO_SIDED|95.0|0.696|1.005||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs EP. HR \<1 favors D + T + EP to be associated with a longer PFS than EP.||1.005|0.696|0.0568
71034114|NCT03043872|141577808|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.754|TWO_SIDED|95.0|0.857|1.235||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs D + EP. HR \<1 favors D + T + EP to be associated with a longer PFS than D + EP.||1.235|0.857|0.7540
71034115|NCT03043872|141577809|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0177|TWO_SIDED|95.0|1.086|2.401||Analysis was performed using a logistic regression model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin). P-value is based on twice the change in log-likelihood resulting from addition of a treatment factor to the model.|Regression, Logistic|||D + EP vs EP. An odds ratio \>1 favors D + EP.||2.401|1.086|0.0177
71034116|NCT03043872|141577809|SUPERIORITY||Odds Ratio (OR)|1.19||||0.3611|TWO_SIDED|95.0|0.817|1.746||Analysis was performed using a logistic regression model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin). P-value is based on twice the change in log-likelihood resulting from addition of a treatment factor to the model.|Regression, Logistic|||D + T + EP vs EP. An odds ratio \>1 favors D + T + EP.||1.746|0.817|0.3611
71034117|NCT03043872|141577821|OTHER||Hazard Ratio (HR)|0.86||||0.447|TWO_SIDED|95.0|0.574|1.277||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs D + EP. HR \<1 favors D + T + EP to be associated with a longer OS than D + EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||1.277|0.574|0.4470
71034118|NCT03043872|141577822|OTHER||Hazard Ratio (HR)|0.97||||0.8934|TWO_SIDED|95.0|0.661|1.437||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + EP vs EP. HR \<1 favors D + EP to be associated with a longer PFS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||1.437|0.661|0.8934
70975901|NCT01070329|141459687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|||<|0.001|TWO_SIDED|95.0|-0.75|-0.22||The P-value is for the main effect of treatment. The a priori threshold for statistical significance is 0.05.|Mixed Models Analysis|||||-0.22|-0.75|<0.001
70975902|NCT01070329|141459688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2|||<|0.001|TWO_SIDED|95.0|-5.77|-2.62||The a priori threshold for statistical significance is 0.05.|Mixed Models Analysis|||||-2.62|-5.77|<0.001
70975903|NCT01070329|141459689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|||<|0.001|TWO_SIDED|95.0|-1.47|-0.42||This is the p-value for the Disrupt Work/School Work score. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||||-0.42|-1.47|<0.001
70975904|NCT01070329|141459689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|||<|0.001|TWO_SIDED|95.0|-1.42|-0.53||This the p-value for the Disrupt Social Life/Leisure score. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||||-0.53|-1.42|<0.001
70975905|NCT01070329|141459689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|||<|0.001|TWO_SIDED|95.0|-1.41|-0.49||This is the p-value for the Disrupt Family Life/Home score. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||||-0.49|-1.41|<0.001
70975906|NCT01070329|141459689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.88|||<|0.001|TWO_SIDED|95.0|-4.16|-1.61||P-value for the SDS Total score. First gated secondary outcome measure. Gatekeeper strategy controlled experiment-wise type I error for 5 secondary outcomes with stepwise comparisons of treatments until outcome failed to be significant (p\>0.05).|Mixed Models Analysis|||||-1.61|-4.16|<0.001
70975907|NCT01070329|141459690|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the second gated secondary outcome measure. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|Cochran-Mantel-Haenszel|||||||<0.001
70975908|NCT01070329|141459691|SUPERIORITY_OR_OTHER|||||||0.173||95.0||||This third gated secondary outcome measure failed to meet statistical significance. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes.|Cochran-Mantel-Haenszel|||||||0.173
70975909|NCT01070329|141459692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.81|||||TWO_SIDED|95.0|-4.13|-1.48|||Mixed Models Analysis|Fourth gated secondary outcome measure. Statistical significance was not evaluated; prior gated secondary outcome measure failed (p\>0.05).||||-1.48|-4.13|
70975910|NCT01070329|141459693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67||||0.05|TWO_SIDED|95.0|0.0|3.34||This is the p-value for the Change at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||3.34|0.00|0.050
71034119|NCT03043872|141577822|OTHER||Hazard Ratio (HR)|0.72||||0.1035|TWO_SIDED|95.0|0.487|1.068||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs EP. HR \<1 favors D + T + EP to be associated with a longer PFS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||1.068|0.487|0.1035
70975911|NCT01070329|141459693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39||||0.071|TWO_SIDED|95.0|-0.12|2.9||This is the p-value for the Change up to Week 8. P-values were not adjusted for multiple comparisons; a priori statistical significance was 0.05.|ANCOVA|||||2.90|-0.12|0.071
71095721|NCT02762604|141699852|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-0.04|0.12|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in cortical thickness pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||0.12|-0.04|
71095722|NCT06038643|141699855|OTHER||||||<|0.001||||||Adjusted for multiple comparisons using False Discovery Rate.|Wilcoxon (Mann-Whitney)|||||||<0.001
70975912|NCT01070329|141459694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.91||||0.05|TWO_SIDED|95.0|0.0|3.82||This is the p-value for the Change from Baseline in SBP at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||3.82|0.00|0.050
70975913|NCT01070329|141459694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.007|TWO_SIDED|95.0|0.5|3.1||This is the p-value for the Change from Baseline in DBP at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||3.10|0.50|0.007
70975914|NCT01070329|141459694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.063|TWO_SIDED|95.0|-0.09|3.5||This is the p-value for the Change from Baseline in SBP up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||3.50|-0.09|0.063
70975915|NCT01070329|141459694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81||||0.004|TWO_SIDED|95.0|0.6|3.02||This is the p-value for the Change from Baseline in DBP up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||3.02|0.60|0.004
70975916|NCT01070329|141459695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.07|||||TWO_SIDED|95.0|-3.18|-0.96|||Mixed Models Analysis|Fifth gated secondary outcome measure. Statistical significance was not evaluated; the third gated secondary outcome measure failed (p\>0.05).||||-0.96|-3.18|
70975917|NCT01070329|141459696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.007|TWO_SIDED|95.0|-0.93|-0.15||This is the p-value for the Change from Baseline at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.15|-0.93|0.007
70975918|NCT01070329|141459696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.002|TWO_SIDED|95.0|-0.93|-0.22||This is the p-value for the Change from Baseline up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||-0.22|-0.93|0.002
70975919|NCT01070329|141459697|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.021
70975920|NCT01070329|141459698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|||<|0.001|TWO_SIDED|95.0|-0.85|-0.27||This is the p-value for the main effect of treatment for the BPI Severity for Worst Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.27|-0.85|<0.001
70975921|NCT01070329|141459698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.003|TWO_SIDED|95.0|-0.64|-0.13||This is the p-value for main effect of treatment for the BPI Severity for Least Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.13|-0.64|0.003
70975922|NCT01070329|141459698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|||<|0.001|TWO_SIDED|95.0|-0.75|-0.22||This is the p-value for the main effect of treatment for the BPI Severity for Average Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.22|-0.75|<0.001
70975923|NCT01070329|141459698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|||<|0.001|TWO_SIDED|95.0|-0.86|-0.27||This is the p-value for the main effect of treatment for the BPI Severity for Pain Right Now score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.27|-0.86|<0.001
70975924|NCT01070329|141459698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.008|TWO_SIDED|95.0|-0.75|-0.11||This is the p-value for the main effect of treatment for the BPI Pain Interference with General Activity score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.11|-0.75|0.008
70975925|NCT01070329|141459698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.004|TWO_SIDED|95.0|-0.8|-0.15||This is the p-value for the main effect of treatment for the BPI Pain Interference with Mood score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.15|-0.80|0.004
70975926|NCT01070329|141459698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.006|TWO_SIDED|95.0|-0.72|-0.12||This is the p-value for the main effect of treatment for the BPI Pain Interference with Walking Ability Score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.12|-0.72|0.006
70975927|NCT01070329|141459698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.012|TWO_SIDED|95.0|-0.72|-0.09||This is the p-value for the main effect of treatment for the BPI Pain Interference with Normal Work score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.09|-0.72|0.012
70975928|NCT01070329|141459698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.029|TWO_SIDED|95.0|-0.7|-0.04||This is the p-value for the main effect of treatment for the BPI Pain Interference with Relations with Others score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.04|-0.70|0.029
71034120|NCT03043872|141577822|OTHER||Hazard Ratio (HR)|0.76||||0.1673|TWO_SIDED|95.0|0.522|1.116||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs D + EP. HR \<1 favors D + T + EP to be associated with a longer PFS than D + EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||1.116|0.522|0.1673
71034121|NCT03043872|141577823|OTHER||Odds Ratio (OR)|1.39||||0.432|TWO_SIDED|95.0|0.61|3.244||Analysis was performed using a logistic regression model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin). P-value is based on twice the change in log-likelihood resulting from addition of a treatment factor to the model.|Regression, Logistic|||D + EP vs EP. An odds ratio \>1 favors D + EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||3.244|0.610|0.4320
71034122|NCT03043872|141577823|OTHER||Odds Ratio (OR)|2.07||||0.0986|TWO_SIDED|95.0|0.874|5.118||Analysis was performed using a logistic regression model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin). P-value is based on twice the change in log-likelihood resulting from addition of a treatment factor to the model.|Regression, Logistic|||D + T + EP vs EP. An odds ratio \>1 favors D + T + EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||5.118|0.874|0.0986
70975929|NCT01070329|141459698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.037|TWO_SIDED|95.0|-0.75|-0.02||This is the p-value for the main effect of treatment for the BPI Pain Interference with Sleep score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.02|-0.75|0.037
71095723|NCT06038643|141699858|SUPERIORITY||||||<|0.01|||||||ANCOVA|||We conducted one-way analyses of covariance (ANCOVAs) to assess the effect of group (intervention vs. control) on post-intervention secondary outcomes, including cognition (Test My Brain Digital Neuropsychology Toolkit). Covariates in all models included age, sex, years of education, APOE4 status, and baseline scores.||||<0.01
71095724|NCT00762177|141699870|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71095725|NCT00762177|141699871|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70975930|NCT01070329|141459698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.006|TWO_SIDED|95.0|-0.81|-0.14||This is the p-value for the main effect of treatment for the BPI Pain Interference with Enjoyment of Life score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.14|-0.81|0.006
70975931|NCT01070329|141459698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.004|TWO_SIDED|95.0|-0.74|-0.15||This is the p-value for the main effect of treatment for the BPI Interference score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.15|-0.74|0.004
70975932|NCT01070329|141459699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-0.9|-0.49||P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.49|-0.90|<0.001
70975933|NCT01070329|141459700|SUPERIORITY_OR_OTHER|||||||0.116||95.0||||This is the p-value for Suicidal Ideation. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.116
70975934|NCT06062264|141459705|SUPERIORITY||Adjusted Risk Ratio|1.03|||||TWO_SIDED|95.0|1.0|1.06||||||Comparing the risk of receiving an influenza vaccination|Adjusted risk ratio. These results compare arms which received portal-based PCP video reminder messages to the arm receiving standard health system portal messages (control).|1.06|1.00|
70975935|NCT06062264|141459705|SUPERIORITY||Adjusted Risk Ratio|1.02|||||TWO_SIDED|95.0|0.99|1.06|||||Adjusted risk ratio. These results compare arms which received portal-based PCP video reminder messages to the arm receiving standard health system portal messages (control).|Comparing the risk of receiving an influenza vaccination||1.06|0.99|
70975936|NCT00700180|141459707|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.8127|TWO_SIDED|95.0|0.63|1.8||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||bFGF (high versus low)||1.80|0.63|0.8127
70975937|NCT00700180|141459707|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.0285|TWO_SIDED|95.0|1.06|3.08||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||E-selectin (high versus low)||3.08|1.06|0.0285
70922128|NCT03363854|141334543|SUPERIORITY||Risk Difference (RD)|17.6|||<|0.001|TWO_SIDED|95.0|8.0|27.1||The statistical test was not controlled for multiplicity.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their DLQI value at Week 16.||27.1|8.0|<0.001
70922129|NCT01903811|141334557|SUPERIORITY||Hazard Ratio (HR)|1.061||||0.384|TWO_SIDED|80.0|0.821|1.37||Stratified by pre-specified randomization stratification factors: 1 - 3 prior therapies vs. 4-6 prior therapies and refractory to bortezomib vs. not refractory to bortezomib.|Log Rank|One-sided stratified log rank test||||1.370|0.821|0.384
70922130|NCT01903811|141334558|SUPERIORITY||Hazard Ratio (HR)|1.149||||0.284|TWO_SIDED|80.0|0.841|1.571||Stratified by pre-specified randomization stratification factors: 1 - 3 prior therapies vs. 4-6 prior therapies and refractory to bortezomib vs. not refractory to bortezomib.|Log Rank|One-sided stratified log rank test||||1.571|0.841|0.284
70922131|NCT01903811|141334559|SUPERIORITY|||||||0.113|||||||Cochran-Mantel-Haenszel|||Compare the rate of confirmed PR or better between treatment arms.||||0.1130
70922132|NCT01704079|141334762|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70922133|NCT01704079|141334763|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70922134|NCT01704079|141334764|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70922135|NCT01704079|141334765|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70922136|NCT03456076|141334810|SUPERIORITY||Hazard Ratio (HR)|0.24||||0.0001|TWO_SIDED|95.0|0.13|0.45|||Log Rank|||||0.45|0.13|.0001
70922137|NCT03456076|141334810|SUPERIORITY||Hazard Ratio (HR)|0.24||||0.0001|TWO_SIDED|95.0|0.13|0.43|||Log Rank|||||0.43|0.13|.0001
70922138|NCT04059042|141334827|EQUIVALENCE|Between-session pain measures were assessed with related-samples Wilcoxon signed-rank tests (Audio minus Silence). Data were not normally distributed so nonparametric tests were used.|Z score|39.0||||0.0051|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0051
70922139|NCT04059042|141334827|EQUIVALENCE|Between-session change scores were calculated per participant as Audio minus Silence and compared between groups with independent samples Mann-Whitney U-tests. Data were not normally distributed so nonparametric tests were used.|Z score|19.0||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.03
70922140|NCT04059042|141334828|EQUIVALENCE|Between-session pain measures were assessed with related-samples Wilcoxon signed-rank tests (Audio minus Silence). Data were not normally distributed so nonparametric tests were used.|Z score|18.0||||0.59|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.59
70922141|NCT04059042|141334828|EQUIVALENCE|Between-session change scores were calculated per participant as Audio minus Silence and compared between groups with independent samples Mann-Whitney U-tests. Data were not normally distributed so nonparametric tests were used.|Z score|14.0||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.41
70922142|NCT00818246|141334848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.94|STANDARD_ERROR_OF_MEAN|2.68|<|0.0001|||||||ANCOVA|analysis of covariance (ANCOVA) was used to assess statistical differences between the LED-treated and untreated sides taking into account Age.||Sample sizes and power calculations were generated according to the primary outcome measures of the study. In order to have a 98% chance of detecting as significant (at the two sided 5% level) a 10% difference between the treated and untreated/control sides in the Ra and Rz post-treatment improvement, with an assumed standard deviation of 10, 33 subjects were required. To account for an 80% per protocol completion rate, the planned number of patients to be enrolled was 40.||||<0.0001
70922143|NCT00818246|141334849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.605|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|||||||ANCOVA|||||||<0.001
70922144|NCT00818246|141334850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.4|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|||||||ANCOVA|analysis of covariance (ANCOVA) was used to assess statistical differences between the LED-treated and untreated sides taking into account Age.||Sample sizes and power calculations were generated according to the primary outcome measures of the study. In order to have a 98% chance of detecting as significant (at the two sided 5% level) a 10% difference between the treated and untreated/control sides in the Ra and Rz post-treatment improvement, with an assumed standard deviation of 10, 33 subjects were required. To account for an 80% per protocol completion rate, the planned number of patients to be enrolled was 40.||||<0.0001
70922145|NCT04788641|141334880|OTHER||Geometric LS Mean Ratio (%)|71.1|||||TWO_SIDED|90.0|65.44|77.24|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Tacrolimus||77.24|65.44|
70922146|NCT04788641|141334880|OTHER||Geometric LS Mean Ratio (%)|102.9|||||TWO_SIDED|90.0|96.11|110.1|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Cyclosporin||110.1|96.11|
70975938|NCT00700180|141459707|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.7478|TWO_SIDED|95.0|0.64|1.85||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||ICAM (high versus low)||1.85|0.64|0.7478
71034123|NCT03649477|141577835|SUPERIORITY||Mean Difference (Net)|-1.202||||0.3493|TWO_SIDED|95.0|-3.729|1.324||0.05 threshold for statistical significance|Mixed Models Analysis|||||1.324|-3.729|0.3493
71034124|NCT03649477|141577835|SUPERIORITY||Mean Difference (Net)|-3.136||||0.0162|TWO_SIDED|95.0|-5.685|-0.586||0.05 threshold for statistical significance|Mixed Models Analysis|||||-0.586|-5.685|0.0162
71034125|NCT03649477|141577836|SUPERIORITY||Mean Difference (Net)|-0.608||||0.6001|TWO_SIDED|95.0|-2.89|1.674||0.05 threshold for statistical significance|Mixed Models Analysis|||||1.674|-2.890|0.6001
71034126|NCT03649477|141577836|SUPERIORITY||Mean Difference (Net)|-0.764||||0.5143|TWO_SIDED|95.0|-3.068|1.541||0.05 threshold for statistical significance|Mixed Models Analysis|||||1.541|-3.068|0.5143
71034127|NCT03649477|141577837|SUPERIORITY||Mean Difference (Net)|0.183||||0.9144|TWO_SIDED|95.0|-3.175|3.541||0.05 threshold for statistical significance|Mixed Models Analysis|||||3.541|-3.175|0.9144
71034128|NCT03649477|141577837|SUPERIORITY||Mean Difference (Net)|-3.812||||0.0266|TWO_SIDED|95.0|-7.177|-0.446||0.05 threshold for statistical significance|Mixed Models Analysis|||||-0.446|-7.177|0.0266
71034129|NCT03649477|141577838|SUPERIORITY||Mean Difference (Net)|-0.312||||0.1598|TWO_SIDED|95.0|-0.748|0.125||0.05 threshold for statistical significance|Mixed Models Analysis|||||0.125|-0.748|0.1598
71034130|NCT03649477|141577838|SUPERIORITY||Mean Difference (Net)|-0.498||||0.0266|TWO_SIDED|95.0|-0.937|-0.059||0.05 threshold for statistical significance|Mixed Models Analysis|||||-0.059|-0.937|0.0266
71034131|NCT03649477|141577839|SUPERIORITY||Mean Difference (Net)|-1.085||||0.2479|TWO_SIDED|95.0|-2.932|0.761||0.05 threshold for statistical significance|Mixed Models Analysis|||||0.761|-2.932|0.2479
71034132|NCT03649477|141577839|SUPERIORITY||Mean Difference (Net)|-2.412||||0.0114|TWO_SIDED|95.0|-4.276|-0.548||0.05 for statistical significance|Mixed Models Analysis|||||-0.548|-4.276|0.0114
71034133|NCT04870606|141577885|SUPERIORITY||Mean Difference (Final Values)|0.025||||0.0181|ONE_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0181
71034134|NCT04870606|141577886|SUPERIORITY||Mean Difference (Final Values)|0.025||||0.1223|ONE_SIDED||||||Chi-squared|||||||0.1223
71034135|NCT04870606|141577887|SUPERIORITY||Mean Difference (Final Values)|0.025||||0.0038|ONE_SIDED||||||t-test, 2 sided|||||||0.0038
71034136|NCT00859430|141577921|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|105.0||||||90.0|98.6|112.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||112|98.6|
71034137|NCT00859430|141577922|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|98.6||||||90.0|96.2|101.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101|96.2|
71034138|NCT00859430|141577923|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|98.4||||||90.0|95.9|101.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101|95.9|
71034139|NCT02545283|141577947|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.5752|TWO_SIDED|95.0|0.81|1.45|||Log Rank|||||1.45|0.81|0.5752
71034140|NCT03635320|141577982|NON_INFERIORITY|non-inferiority margin of -10%|95%CI|0.0|||||TWO_SIDED|95.0|-4.53|4.42|||Newcombe-Wilson scoring method|Using the Newcombe-Wilson scoring method, the difference of fracture union rate between the TFNA group and the PFNA-II group was 0.|If the lower limit of 95% CI of the difference in the rates of the study group and the control group is greater than the non-inferiority margin of -10%, then the investigational product is considered non-inferior to the control product.|||4.42|-4.53|
71034141|NCT00835575|141577998|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.52||||||90.0|92.84|106.69|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106.69|92.84|
71034142|NCT00835575|141577999|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.59||||||90.0|99.13|108.25|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.25|99.13|
71034143|NCT00835575|141578000|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.87||||||90.0|99.47|108.46|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.46|99.47|
71034144|NCT00761813|141578020|SUPERIORITY||Cox Proportional Hazard|0.83|||||TWO_SIDED|95.0|0.63|1.09||||||||1.09|.63|
71034145|NCT00761813|141578021|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
71034146|NCT01667679|141578055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.39|STANDARD_ERROR_OF_MEAN|0.824|<|0.0001|TWO_SIDED|95.0|1.76|5.01|||ANCOVA|||||5.01|1.76|<0.0001
71034147|NCT01667679|141578056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.66|STANDARD_ERROR_OF_MEAN|1.105||0.0013|TWO_SIDED|95.0|1.47|5.85|||ANCOVA||mild attacks|||5.85|1.47|0.0013
71034148|NCT01667679|141578056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.76|STANDARD_ERROR_OF_MEAN|0.971||0.0002|TWO_SIDED|95.0|1.84|5.68|||ANCOVA||moderate/severe attacks|||5.68|1.84|0.0002
71034149|NCT01667679|141578057|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.3549|TWO_SIDED|95.0|0.85|1.6|||ANCOVA||10 minutes post-dose|||1.60|0.85|0.3549
71034150|NCT01667679|141578057|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.0005|TWO_SIDED|95.0|1.2|1.9|||ANCOVA||15 minutes post-dose|||1.90|1.20|0.0005
71034151|NCT01667679|141578057|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.79|||<|0.0001|TWO_SIDED|95.0|1.45|2.21|||ANCOVA||30 minutes post-dose|||2.21|1.45|<0.0001
71034152|NCT01667679|141578057|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.0002|TWO_SIDED|95.0|1.24|1.96|||ANCOVA||45 minutes post-dose|||1.96|1.24|0.0002
71034153|NCT01667679|141578057|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.0057|TWO_SIDED|95.0|1.1|1.71|||ANCOVA||60 minutes post-dose|||1.71|1.10|0.0057
71034154|NCT01667679|141578057|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.0654|TWO_SIDED|95.0|0.99|1.61|||ANCOVA||90 minutes post-dose|||1.61|0.99|0.0654
70975939|NCT00700180|141459707|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.6761|TWO_SIDED|95.0|0.58|2.33||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||PlGF (high versus low)||2.33|0.58|0.6761
70975940|NCT00700180|141459707|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.4601|TWO_SIDED|95.0|0.72|2.09||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||VEGF A (high versus low)||2.09|0.72|0.4601
70975941|NCT00700180|141459707|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.3193|TWO_SIDED|95.0|0.46|1.29||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||VEGFR-1 (high versus low)||1.29|0.46|0.3193
70975942|NCT00700180|141459707|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.1758|TWO_SIDED|95.0|0.85|2.45||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||VEGFR-2 (high versus low)||2.45|0.85|0.1758
70975943|NCT00700180|141459709|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9454|TWO_SIDED|95.0|0.78|1.31|||Log Rank|||||1.31|0.78|0.9454
70975944|NCT00700180|141459710|SUPERIORITY_OR_OTHER||Difference in Responses Rates|9.34||||0.1737|TWO_SIDED|95.0|-2.4|21.0|||Cochran-Mantel-Haenszel||Approximate 95% Confidence Interval (CI) for difference of two rates using Hauck-Anderson method.|||21.0|-2.4|0.1737
70975945|NCT00700180|141459711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.75||||0.6148|TWO_SIDED|95.0|-8.2|11.7|||Cochran-Mantel-Haenszel||Approximate 95% CI for difference of two rates using Hauck-Anderson method|||11.7|-8.2|0.6148
70975946|NCT00700180|141459713|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.7587|TWO_SIDED|95.0|0.68|1.69|||Log Rank|||||1.69|0.68|0.7587
70975947|NCT00700180|141459715|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.312|TWO_SIDED|95.0|0.87|1.53|||Log Rank|||||1.53|0.87|0.3120
70975948|NCT02522767|141459770|SUPERIORITY||Odds Ratio (OR)|1.55|||>|0.05|TWO_SIDED|95.0|0.73|3.32||The p-value was based on chi-square test without a continuity correction.|Chi-squared|||Proportions were compared between treatment groups, at a two-sided 0.05 significance level.||3.32|0.73|>0.05
70975949|NCT02522767|141459773|SUPERIORITY||Odds Ratio (OR)|1.78|||>|0.05|TWO_SIDED|95.0|0.96|3.29||The p-value was based on chi-square test without a continuity correction.|Chi-squared|||Proportions were compared between treatment groups at a two-sided 0.05 significance level.||3.29|0.96|>0.05
70975950|NCT02522767|141459774|SUPERIORITY||Odds Ratio (OR)|1.3|||>|0.05|TWO_SIDED|95.0|0.78|2.15|||Generalized estimating equation approach|||Proportions were compared between treatment groups over 8 weeks, at a two-sided 0.05 significance level.||2.15|0.78|>0.05
70975951|NCT02522767|141459775|SUPERIORITY||Hazard Ratio (HR)|1.36|||>|0.05|TWO_SIDED|95.0|0.91|2.02||The p-value was based on log-rank test.|Log Rank||Hazard ratio and its 95% CI were obtained from Cox proportional hazards model with treatment group as a factor.|Times to normal stool pattern were compared between treatment groups, at a two-sided 0.05 significance level.||2.02|0.91|>0.05
70975952|NCT02522767|141459776|SUPERIORITY||Treatment difference|-0.24|||<|0.05|TWO_SIDED|95.0|-0.41|-0.08|||Repeated-measures ANCOVA||A repeated-measures ANCOVA model with an unstructured correlation matrix was used to calculate estimate.|Change from baseline scores were compared between treatment groups over 8 weeks, at a two-sided 0.05 significance level.||-0.08|-0.41|<0.05
70975953|NCT02522767|141459777|SUPERIORITY||Treatment difference|-2.39|||>|0.05|TWO_SIDED|95.0|-5.46|0.67|||Repeated-measures ANCOVA||A repeated-measures ANCOVA model with an unstructured correlation matrix was used to calculate estimate.|Change from baseline scores were compared between treatment groups over 8 weeks, at a two-sided 0.05 significance level.||0.67|-5.46|>0.05
70975954|NCT02522767|141459778|SUPERIORITY||Treatment difference|-289.69|||<|0.05|TWO_SIDED|95.0|-514.96|-64.42|||ANCOVA||An ANCOVA model was used to calculate estimates.|Changes from baseline were compared between treatment groups, at a two-sided 0.05 significance level.||-64.42|-514.96|<0.05
70975955|NCT02522767|141459779|SUPERIORITY||Treatment difference|12.8|||<|0.05|TWO_SIDED|95.0|5.1|20.5|||Repeated-measures ANCOVA||A repeated-measures ANCOVA model with an unstructured correlation matrix was used to calculate estimates.|Change from baseline scores were compared between treatment groups over 8 weeks, at a two-sided 0.05 significance level.||20.50|5.10|<0.05
70975956|NCT04233229|141459816|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time In Range (TIR) at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|27.4|STANDARD_ERROR_OF_MEAN|6.0|<|0.001|TWO_SIDED|95.0|15.0|39.8||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||39.8|15.0|<.001
70975957|NCT04233229|141459817|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time In Range (TIR) during diurnal period at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|23.0|STANDARD_ERROR_OF_MEAN|6.0|<|0.001|TWO_SIDED|95.0|10.6|35.5||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||35.5|10.6|<.001
70975958|NCT04233229|141459818|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time In Range (TIR) during nocturnal period at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|40.8|STANDARD_ERROR_OF_MEAN|7.2|<|0.001|TWO_SIDED|95.0|25.8|55.8||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||55.8|25.8|<.001
71034155|NCT01667679|141578057|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.2894|TWO_SIDED|95.0|0.89|1.49|||ANCOVA||120 minutes post-dose|||1.49|0.89|0.2894
71034156|NCT01667679|141578058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.1771|TWO_SIDED|95.0|0.76|4.54|||ANCOVA||10 minutes post-dose|||4.54|0.76|0.1771
71034157|NCT01667679|141578058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.03||||0.0077|TWO_SIDED|95.0|1.21|3.42|||ANCOVA||15 minutes post-dose|||3.42|1.21|0.0077
71034158|NCT01667679|141578058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.82||||0.0003|TWO_SIDED|95.0|1.32|2.5|||ANCOVA||30 minutes post-dose|||2.50|1.32|0.0003
70975959|NCT04233229|141459819|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time Above Range (TAR) at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|-27.7|STANDARD_ERROR_OF_MEAN|6.1|<|0.001|TWO_SIDED|95.0|-40.5|-15.0||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||-15.0|-40.5|<.001
70975960|NCT04233229|141459820|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time Above Range (TAR) at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|-20.1|STANDARD_ERROR_OF_MEAN|5.9||0.003|TWO_SIDED|95.0|-32.4|-7.9||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||-7.9|-32.4|0.003
70975961|NCT04233229|141459821|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time Below Range (TBR) at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|0.1|STANDARD_ERROR_OF_MEAN|0.5||0.79|TWO_SIDED|95.0|-1.0|1.3||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||1.3|-1.0|0.79
70975962|NCT04233229|141459822|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time Below Range (TBR) at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.84|TWO_SIDED|95.0|-0.3|0.4||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||0.4|-0.3|0.84
70975963|NCT04233229|141459823|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and glucose variability (% CV Coefficient of Variation) at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|3.7|STANDARD_ERROR_OF_MEAN|1.9||0.06|TWO_SIDED|95.0|-0.2|7.6||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||7.6|-0.2|0.060
70975964|NCT04233229|141459824|SUPERIORITY|Analysis of covariance (ANCOVA) model with 2 factors: HbA1c value at baseline and study group|Adjusted means difference|-1.3|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.9|-0.7||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||-0.7|-1.9|<.001
70975965|NCT04233229|141459825|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and total daily insulin dose at selection|Adjusted means difference|-18.5|STANDARD_ERROR_OF_MEAN|28.5||0.52|TWO_SIDED|95.0|-78.2|41.2||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||41.2|-78.2|0.52
70975966|NCT04233229|141459826|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and body weight at study initiation visit|Adjusted means difference|2.8|STANDARD_ERROR_OF_MEAN|1.6||0.08|TWO_SIDED|95.0|-0.4|6.1||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||6.1|-0.4|0.08
70975967|NCT02631538|141459847|OTHER||Least square (LS) mean difference|-2.86|STANDARD_ERROR_OF_MEAN|1.758|||TWO_SIDED|95.0|-6.38|0.67|||||Week 12. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||0.67|-6.38|
70975968|NCT02631538|141459847|OTHER||LS mean difference|-0.99|STANDARD_ERROR_OF_MEAN|1.382|||TWO_SIDED|95.0|-3.75|1.78|||||Week 12. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.78|-3.75|
70975969|NCT02631538|141459847|OTHER||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|1.442|||TWO_SIDED|95.0|-3.52|2.26|||||Week 12. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||2.26|-3.52|
70975970|NCT02631538|141459847|OTHER||LS mean difference|-1.87|STANDARD_ERROR_OF_MEAN|1.732|||TWO_SIDED|95.0|-5.34|1.6|||||Week 12. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.60|-5.34|
70975971|NCT02631538|141459847|OTHER||LS mean difference|0.35|STANDARD_ERROR_OF_MEAN|1.422|||TWO_SIDED|95.0|-2.5|3.2|||||Week 12. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||3.20|-2.50|
70975972|NCT02631538|141459847|OTHER||LS mean difference|-2.45|STANDARD_ERROR_OF_MEAN|1.607|||TWO_SIDED|95.0|-5.67|0.77|||||Week 24. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||0.77|-5.67|
70975973|NCT02631538|141459847|OTHER||LS mean difference|-1.46|STANDARD_ERROR_OF_MEAN|1.265|||TWO_SIDED|95.0|-3.99|1.08|||||Week 24. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.08|-3.99|
71034159|NCT01667679|141578058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64|||<|0.0001|TWO_SIDED|95.0|1.29|2.09|||ANCOVA||45 minutes post-dose|||2.09|1.29|<0.0001
71034160|NCT01667679|141578058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.0016|TWO_SIDED|95.0|1.14|1.74|||ANCOVA||60 minutes post-dose|||1.74|1.14|0.0016
71034161|NCT01667679|141578058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.0059|TWO_SIDED|95.0|1.09|1.69|||ANCOVA||90 minutes post-dose|||1.69|1.09|0.0059
71034162|NCT01667679|141578058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.2717|TWO_SIDED|95.0|0.91|1.42|||ANCOVA||120 minutes post-dose|||1.42|0.91|0.2717
71034163|NCT01667679|141578059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.2426|TWO_SIDED|95.0|0.87|1.77|||ANCOVA||10 minutes post-dose|||1.77|0.87|0.2426
70975974|NCT02631538|141459847|OTHER||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|1.305|||TWO_SIDED|95.0|-2.68|2.55|||||Week 24. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||2.55|-2.68|
70975975|NCT02631538|141459847|OTHER||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|1.584|||TWO_SIDED|95.0|-4.17|2.18|||||Week 24. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||2.18|-4.17|
70975976|NCT02631538|141459847|OTHER||LS mean difference|1.39|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|95.0|-1.2|3.97|||||Week 24. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||3.97|-1.20|
70975977|NCT02631538|141459847|OTHER||LS mean difference|-0.97|STANDARD_ERROR_OF_MEAN|1.845|||TWO_SIDED|95.0|-4.66|2.73|||||Week 36. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||2.73|-4.66|
70975978|NCT02631538|141459847|OTHER||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|1.449|||TWO_SIDED|95.0|-2.76|3.05|||||Week 36. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||3.05|-2.76|
70975979|NCT02631538|141459847|OTHER||LS mean difference|0.85|STANDARD_ERROR_OF_MEAN|1.498|||TWO_SIDED|95.0|-2.15|3.86|||||Week 36. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||3.86|-2.15|
70975980|NCT02631538|141459847|OTHER||LS mean difference|-1.11|STANDARD_ERROR_OF_MEAN|1.817|||TWO_SIDED|95.0|-4.76|2.53|||||Week 36. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||2.53|-4.76|
70975981|NCT02631538|141459847|OTHER||LS mean difference|0.71|STANDARD_ERROR_OF_MEAN|1.476|||TWO_SIDED|95.0|-2.25|3.66|||||Week 36. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||3.66|-2.25|
70975982|NCT02631538|141459847|OTHER||LS mean difference|-2.8|STANDARD_ERROR_OF_MEAN|1.57|||TWO_SIDED|95.0|-5.95|0.34|||||Week 52. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||0.34|-5.95|
70975983|NCT02631538|141459847|OTHER||LS mean difference|-0.91|STANDARD_ERROR_OF_MEAN|1.237|||TWO_SIDED|95.0|-3.39|1.56|||||Week 52. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.56|-3.39|
70975984|NCT02631538|141459847|OTHER||LS mean difference|-1.36|STANDARD_ERROR_OF_MEAN|1.275|||TWO_SIDED|95.0|-3.91|1.2|||||Week 52. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.20|-3.91|
70975985|NCT02631538|141459847|OTHER||LS mean difference|-1.89|STANDARD_ERROR_OF_MEAN|1.548|||TWO_SIDED|95.0|-4.99|1.21|||||Week 52. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.21|-4.99|
70975986|NCT02631538|141459847|OTHER||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|1.261|||TWO_SIDED|95.0|-2.97|2.08|||||Week 52. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||2.08|-2.97|
70975987|NCT02631538|141459847|OTHER||LS mean difference|-3.99|STANDARD_ERROR_OF_MEAN|1.699|||TWO_SIDED|95.0|-7.39|-0.58|||||Week 68. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||-0.58|-7.39|
70975988|NCT02631538|141459847|OTHER||LS mean difference|-1.87|STANDARD_ERROR_OF_MEAN|1.336|||TWO_SIDED|95.0|-4.54|0.81|||||Week 68. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||0.81|-4.54|
70975989|NCT02631538|141459847|OTHER||LS mean difference|-1.35|STANDARD_ERROR_OF_MEAN|1.379|||TWO_SIDED|95.0|-4.12|1.41|||||Week 68. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.41|-4.12|
70975990|NCT02631538|141459847|OTHER||LS mean difference|-2.12|STANDARD_ERROR_OF_MEAN|1.674|||TWO_SIDED|95.0|-5.47|1.23|||||Week 68. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.23|-5.47|
70975991|NCT02631538|141459847|OTHER||LS mean difference|0.51|STANDARD_ERROR_OF_MEAN|1.362|||TWO_SIDED|95.0|-2.21|3.24|||||Week 68. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||3.24|-2.21|
70975992|NCT00964431|141459851|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.545|STANDARD_ERROR_OF_MEAN|1.8912|<|0.001|TWO_SIDED|95.0|5.816|13.275|||ANCOVA|||||13.275|5.816|<0.001
70975993|NCT01482910|141459855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.1|||<|0.0001|TWO_SIDED|95.0|6.8|13.4||Hierarchical testing procedure was used in the order of pre-defined fixed sequence (primary endpoint first, then confirmatory secondary efficacy point next). A two-sided significance level of 0.05 was used.|ANCOVA|ANCOVA with baseline BCVA as a covariate, and treatment group and baseline BCVA group (\<45 letters vs ≥45 letters) as fixed factors|Least square mean difference (EYLEA-PDT) was estimated from ANCOVA, where a positive value is in favor of EYLEA.|Null hypothesis: mean changes are identical in both groups. A sample size of 300 subjects with a 3:1 (EYLEA to PDT) randomization ratio is sufficient to detect the superiority of EYLEA to PDT assuming a two-sided alpha level of 0.05, a power of 90%, a treatment difference of 7.5 letters and a common standard deviation of 14 letters.||13.4|6.8|<0.0001
71034164|NCT01667679|141578059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.0069|TWO_SIDED|95.0|1.12|1.99|||ANCOVA||15 minutes post-dose|||1.99|1.12|0.0069
70922147|NCT04788641|141334881|OTHER||Geometric LS Mean Ratio (%)|62.91|||||TWO_SIDED|90.0|55.64|71.13|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Tacrolimus||71.13|55.64|
70922148|NCT04788641|141334881|OTHER||Geometric LS Mean Ratio (%)|97.23|||||TWO_SIDED|90.0|92.93|101.7|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Cyclosporin||101.7|92.93|
70922149|NCT04788641|141334882|OTHER||Geometric LS Mean Ratio (%)|65.57|||||TWO_SIDED|90.0|58.69|73.24|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Tacrolimus||73.24|58.69|
70922150|NCT04788641|141334882|OTHER||Geometric LS Mean Ratio (%)|97.04|||||TWO_SIDED|90.0|92.7|101.6|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Cyclosporin||101.6|92.70|
70922151|NCT04788641|141334883|OTHER||Geometric LS Mean Ratio (%)|83.86|||||TWO_SIDED|90.0|73.38|95.84|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Tacrolimus||95.84|73.38|
70922152|NCT04788641|141334883|OTHER||Geometric LS Mean Ratio (%)|97.55|||||TWO_SIDED|90.0|87.16|109.2|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Cyclosporin||109.2|87.16|
70922153|NCT04788641|141334884|OTHER||Geometric LS Mean Ratio (%)|98.42|||||TWO_SIDED|90.0|94.62|102.4|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Tacrolimus||102.4|94.62|
70922154|NCT04788641|141334884|OTHER||Geometric LS Mean Ratio (%)|94.12|||||TWO_SIDED|90.0|85.74|103.3|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Cyclosporin||103.3|85.74|
70922155|NCT03283371|141334886|SUPERIORITY||LS Mean logarithmic difference|-0.16||||0.5053|TWO_SIDED|95.0|-0.62|0.31|||Mixed Model for Repeated Measures (MMRM)|||Analysis is based on MMRM and adjusted for natural log-transformed baseline seizure frequency, high seizure frequency category (\>=24 seizures and \<24 seizures), structural etiology category (yes and no), visit, treatment and treatment by visit interaction. An unstructured variance-covariance matrix is used in the model.||0.31|-0.62|0.5053
70922156|NCT03283371|141334887|SUPERIORITY||Odds Ratio (OR)|2.09||||0.2231|TWO_SIDED|95.0|0.64|6.85|||Regression, Logistic|||Based on logistic regression with a term for treatment group and with adjustment for natural log-transformed baseline seizure frequency, high seizure frequency category (\>=24 seizures and \<24 seizures) and structural etiology category (yes and no).||6.85|0.64|0.2231
70922157|NCT03283371|141334890|SUPERIORITY||Odds Ratio (OR)|0.67||||0.6854|TWO_SIDED|95.0|0.1|4.57|||Regression, Logistic|||Based on the logistic regression model with a term for treatment group and with adjustment for log-transformed baseline seizure frequency, high seizure frequency category (\>=24 seizures and \<24 seizures) and structural etiology category (yes and no) are considered as covariates.||4.57|0.10|0.6854
70975994|NCT01482910|141459856|SUPERIORITY_OR_OTHER||Risk Difference (RD)|6.6||||0.0359|TWO_SIDED|95.0|0.4|12.9||Hierarchical testing procedure was used in the order of pre-defined fixed sequence (primary endpoint first, then confirmatory secondary efficacy point next). A two-sided significance level of 0.05 was used.|Cochran-Mantel-Haenszel|CMH adjusted for baseline BCVA group (\<45 letters vs ≥45 letters)|Proportion difference (EYLEA-PDT) was estimated from CMH, where a positive value is in favor of EYLEA.|Null hypothesis: proportions are identical in both groups||12.9|0.4|0.0359
70922158|NCT00093015|141334915|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.05||||0.41||95.0|0.94|1.17||Nominal p-value from a 2-sided log rank test is presented. The primary cardiovascular composite endpoint was tested at the 0.04056 significance level at final analysis after accounting for 4 planned interim analyses (overall alpha = 0.048).|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.17|0.94|0.41
70922159|NCT00093015|141334916|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.06||||0.29||95.0|0.95|1.19||Nominal p-value from a 2-sided log rank test is presented. The primary renal composite endpoint was tested at the 0.002 significance level at final analysis.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.19|0.95|0.29
70922160|NCT00093015|141334917|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.05||||0.48||95.0|0.92|1.21||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.21|0.92|0.48
70922161|NCT00093015|141334918|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.05||||0.61||95.0|0.88|1.25||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.25|0.88|0.61
70975995|NCT00110019|141459869|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.863|TWO_SIDED|95.0|0.87|1.18|||Log Rank|Stratified log rank test is used for overall survival comparison, stratified on AJCC stage, ECOG Performance status and prior therapy status|Arm II is the reference group|||1.18|0.87|0.863
70975996|NCT00110019|141459870|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.092|TWO_SIDED|95.0|0.78|1.03||priori threshold for statistical significance: P\<0.05|Log Rank|Stratified log rank test is used for progression-free survival comparison, stratified on AJCC stage, ECOG Performance status and prior therapy status|Arm II is the reference group|||1.03|0.78|0.092
70975997|NCT00110019|141459871|SUPERIORITY_OR_OTHER|||||||0.427||95.0||||priori threshold for statistical significance: P\<0.05|Fisher Exact|||||||0.427
70975998|NCT04426695|141459876|SUPERIORITY||Least Square (LS) Mean Difference|-0.25||||0.0663|TWO_SIDED|95.0|-0.51|0.02||P-value for change from baseline on log scale for each treatment group was based on the Analysis of covariance (ANCOVA) model with treatment group.|ANCOVA|||||0.02|-0.51|0.0663
70975999|NCT04426695|141459876|SUPERIORITY||Least Square (LS) Mean Difference|-0.31||||0.0204||95.0|-0.57|0.05||P-value for change from baseline on log scale for each treatment group was based on the Analysis of covariance (ANCOVA) model with treatment group.|ANCOVA|||||0.05|-0.57|0.0204
70976000|NCT04426695|141459876|SUPERIORITY||Least Square (LS) Mean Difference|-0.28||||0.0172|TWO_SIDED|95.0|-0.51|-0.05||P-value for change from baseline on log scale for each treatment group was based on the Analysis of covariance (ANCOVA) model with treatment group.|ANCOVA|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||-0.05|-0.51|0.0172
70976001|NCT04426695|141459877|SUPERIORITY|||||||0.0431||||||P-value was derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0431
70976002|NCT04426695|141459877|SUPERIORITY|||||||0.7975||||||P-value was derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.7975
70976003|NCT04426695|141459877|SUPERIORITY|||||||0.2048||||||P-value was derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||||0.2048
70976004|NCT04426695|141459878|SUPERIORITY|||||||0.0039||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0039
71034165|NCT01667679|141578059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.94|||<|0.0001|TWO_SIDED|95.0|1.47|2.56|||ANCOVA||30 minutes post-dose|||2.56|1.47|<0.0001
71034166|NCT01667679|141578059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.0004|TWO_SIDED|95.0|1.26|2.23|||ANCOVA||45 minutes post-dose|||2.23|1.26|0.0004
70976005|NCT04426695|141459878|SUPERIORITY|||||||0.2415||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2415
70976006|NCT04426695|141459878|SUPERIORITY|||||||0.0195||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||||0.0195
70976007|NCT04426695|141459879|SUPERIORITY|||||||0.0085||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0085
70976008|NCT04426695|141459879|SUPERIORITY|||||||0.9902||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.9902
70976009|NCT04426695|141459879|SUPERIORITY|||||||0.1486||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||||0.1486
70976010|NCT04426695|141459880|SUPERIORITY|||||||0.0092||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0092
70976011|NCT04426695|141459880|SUPERIORITY|||||||0.221||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2210
71034167|NCT01667679|141578059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.0008|TWO_SIDED|95.0|1.22|2.11|||ANCOVA||60 minutes post-dose|||2.11|1.22|0.0008
71034168|NCT01667679|141578059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.0272|TWO_SIDED|95.0|1.04|1.83|||ANCOVA||90 minutes post-dose|||1.83|1.04|0.0272
71034169|NCT01667679|141578059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.2085|TWO_SIDED|95.0|0.9|1.62|||ANCOVA||120 minutes post-dose|||1.62|0.90|0.2085
71034170|NCT01667679|141578061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.021||0.3562|TWO_SIDED|95.0|-0.06|0.02|||ANCOVA||10 minutes post-dose|||0.02|-0.06|0.3562
71034171|NCT01667679|141578061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.029||0.0063|TWO_SIDED|94.0|-0.14|-0.02|||ANCOVA||15 minutes post-dose|||-0.02|-0.14|0.0063
71034172|NCT01667679|141578061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|-0.26|-0.11|||ANCOVA||30 minutes post-dose|||-0.11|-0.26|< 0.0001
71034173|NCT01667679|141578061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.046||0.0005|TWO_SIDED|95.0|-0.26|-0.07|||ANCOVA||45 minutes post-dose|||-0.07|-0.26|0.0005
70976012|NCT04426695|141459880|SUPERIORITY|||||||0.0249||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||||0.0249
70976013|NCT04426695|141459881|SUPERIORITY|||||||0.0045||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0045
70976014|NCT04426695|141459881|SUPERIORITY|||||||0.0714||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0714
70976015|NCT04426695|141459881|SUPERIORITY|||||||0.0061||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||||0.0061
70976016|NCT04426695|141459882|SUPERIORITY|||||||0.0023||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0023
70976017|NCT04426695|141459882|SUPERIORITY|||||||0.3544||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3544
70976018|NCT04426695|141459882|SUPERIORITY|||||||0.0212||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||||0.0212
70976019|NCT04426695|141459888|SUPERIORITY|||||||0.0575||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0575
70976020|NCT04426695|141459888|SUPERIORITY|||||||0.3133||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3133
70976021|NCT04426695|141459888|SUPERIORITY|||||||0.0849||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0849
70976022|NCT04426695|141459889|SUPERIORITY|||||||0.2167||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2167
70976023|NCT04426695|141459889|SUPERIORITY|||||||0.4123||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.4123
70976024|NCT04426695|141459889|SUPERIORITY|||||||0.2206||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2206
70976025|NCT04426695|141459890|SUPERIORITY|||||||0.0383||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0383
70976026|NCT04426695|141459890|SUPERIORITY|||||||0.3296||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3296
70976027|NCT04426695|141459890|SUPERIORITY|||||||0.0766||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0766
70976028|NCT04426695|141459891|SUPERIORITY|||||||0.007||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0070
70976029|NCT04426695|141459891|SUPERIORITY|||||||0.0507||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0507
70976030|NCT04426695|141459891|SUPERIORITY|||||||0.0051||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0051
70976031|NCT04426695|141459892|SUPERIORITY|||||||0.0174||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0174
71034174|NCT01667679|141578061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.048||0.004|TWO_SIDED|95.0|-0.24|-0.05|||ANCOVA||60 minutes post-dose|||-0.05|-0.24|0.0040
70976032|NCT04426695|141459892|SUPERIORITY|||||||0.29||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2900
70976033|NCT04426695|141459892|SUPERIORITY|||||||0.0454||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0454
70976034|NCT04426695|141459893|SUPERIORITY|||||||0.004||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0040
70976035|NCT04426695|141459893|SUPERIORITY|||||||0.0413||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0413
70976036|NCT04426695|141459893|SUPERIORITY|||||||0.0032||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0032
70976037|NCT04426695|141459894|SUPERIORITY|||||||0.0105||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0105
70976038|NCT04426695|141459894|SUPERIORITY|||||||0.0622||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0622
70976039|NCT04426695|141459894|SUPERIORITY|||||||0.0088||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0088
70976040|NCT04426695|141459895|SUPERIORITY|||||||0.0275||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0275
70976041|NCT04426695|141459895|SUPERIORITY|||||||0.0223||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0223
70976042|NCT04426695|141459895|SUPERIORITY|||||||0.0072||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0072
70976043|NCT04426695|141459896|SUPERIORITY|||||||0.1032||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1032
70976044|NCT04426695|141459896|SUPERIORITY|||||||0.335||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3350
70976045|NCT04426695|141459896|SUPERIORITY|||||||0.1314||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1314
70976046|NCT04426695|141459897|SUPERIORITY|||||||0.00024||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.00024
70976047|NCT04426695|141459897|SUPERIORITY|||||||0.0054||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0054
70976048|NCT04426695|141459897|SUPERIORITY|||||||0.0005||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0005
70976049|NCT04426695|141459904|SUPERIORITY|||||||0.0533||||||P-value based on stratified log-rank test with the type of background standard-of-care and baseline serostatus as stratification factors.|Log Rank|||||||0.0533
70976050|NCT04426695|141459904|SUPERIORITY|||||||0.0411||||||P-value based on stratified log-rank test with the type of background standard-of-care and baseline serostatus as stratification factors.|Log Rank|||||||0.0411
70976051|NCT04426695|141459904|SUPERIORITY|||||||0.0229||||||P-value based on stratified log-rank test with the type of background standard-of-care and baseline serostatus as stratification factors.|Log Rank|||||||0.0229
70976052|NCT04426695|141459905|SUPERIORITY|||||||0.0218|||||||Stratified Log Rank Test|||||||0.0218
70976053|NCT04426695|141459905|SUPERIORITY|||||||0.0156|||||||Stratified Log Rank Test|||||||0.0156
70976054|NCT04426695|141459905|SUPERIORITY|||||||0.0067|||||||Stratified Log Rank Test|||||||0.0067
70976055|NCT04426695|141459909|SUPERIORITY|||||||0.2162||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2162
70976056|NCT04426695|141459909|SUPERIORITY|||||||0.8783||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.8783
70976057|NCT04426695|141459909|SUPERIORITY|||||||0.5583||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.5583
70976058|NCT04426695|141459909|SUPERIORITY|||||||0.7189||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.7189
70976059|NCT04426695|141459909|SUPERIORITY|||||||0.0429||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0429
70976060|NCT04426695|141459909|SUPERIORITY|||||||0.2103||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2103
70976061|NCT04426695|141459910|SUPERIORITY|||||||0.0223||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0223
70976062|NCT04426695|141459910|SUPERIORITY|||||||0.1256||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1256
70976063|NCT04426695|141459910|SUPERIORITY|||||||0.023||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0230
70976064|NCT04426695|141459910|SUPERIORITY|||||||0.1298||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1298
70976065|NCT04426695|141459910|SUPERIORITY|||||||0.2642||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2642
70976066|NCT04426695|141459910|SUPERIORITY|||||||0.097||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0970
70976067|NCT04426695|141459911|SUPERIORITY|||||||0.0147||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0147
70976068|NCT04426695|141459911|SUPERIORITY|||||||0.0669||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0669
70976069|NCT04426695|141459911|SUPERIORITY|||||||0.0094||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0094
70976070|NCT04426695|141459911|SUPERIORITY|||||||0.1306||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1306
70976071|NCT04426695|141459911|SUPERIORITY|||||||0.3576||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3576
70976072|NCT04426695|141459911|SUPERIORITY|||||||0.1476||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1476
70976073|NCT04426695|141459912|SUPERIORITY|||||||0.0481||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0481
70976074|NCT04426695|141459912|SUPERIORITY|||||||0.0535||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0535
70976075|NCT04426695|141459912|SUPERIORITY|||||||0.0199||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0199
70976076|NCT04426695|141459912|SUPERIORITY|||||||0.2784||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2784
70976077|NCT04426695|141459912|SUPERIORITY|||||||0.251||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2510
71034175|NCT01667679|141578061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.052||0.0333|TWO_SIDED|95.0|-0.21|-0.01|||ANCOVA||90 minutes post-dose|||-0.01|-0.21|0.0333
70922162|NCT00093015|141334919|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.96||||0.73||95.0|0.75|1.23||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.23|0.75|0.73
70922163|NCT00093015|141334920|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.92|||<|0.001||95.0|1.38|2.68||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||2.68|1.38|<0.001
70922164|NCT00093015|141334921|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.89||||0.24||95.0|0.74|1.08||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.08|0.74|0.24
70922165|NCT00093015|141334922|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.02||||0.83||95.0|0.87|1.18||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.18|0.87|0.83
70922166|NCT00093015|141334923|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.12||||0.54||95.0|-0.51|0.26||Nominal p-value is from the term treatment group\*visit in the mixed model.|Mixed Models Analysis|Adjusted for baseline eGFR and the stratification factors of proteinuria and CVD history.|Estimated difference in rate of decline in eGFR per year between darbepoetin alfa and placebo.|||0.26|-0.51|0.54
70922167|NCT00093015|141334924|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.33|STANDARD_DEVIATION|0.35|<|0.001||95.0|0.64|2.02||Nominal p-value is presented.|t-test, 2 sided||Difference (darbepoetin alfa - placebo)|||2.02|0.64|<0.001
70922168|NCT00093015|141334925|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.84||||0.4||95.0|0.55|1.27||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.27|0.55|0.40
70922169|NCT03398148|141334934|SUPERIORITY||Adjusted Risk Difference|9.6||||0.0324|TWO_SIDED|90.0|2.2|17.0||P-value ≤ 0.05|Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel (CMH) test stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (≤ 7, \> 7).|Risk difference = (risankizumab - Placebo)|||17.0|2.2|0.0324
70922170|NCT03398148|141334934|SUPERIORITY||Adjusted Risk Difference|8.4||||0.046|TWO_SIDED|90.0|1.5|15.3||P-value ≤ 0.05|Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel (CMH) test stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (≤ 7, \> 7).|Risk difference = (risankizumab - Placebo)|||15.3|1.5|0.0460
70976078|NCT04426695|141459912|SUPERIORITY|||||||0.1702||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1702
70922171|NCT03398148|141334934|SUPERIORITY||Adjusted Risk Difference|8.7||||0.0397|TWO_SIDED|90.0|1.7|15.6||P-value ≤ 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel (CMH) test stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (≤ 7, \> 7).|Risk difference = (risankizumab - Placebo).|||15.6|1.7|0.0397
70922172|NCT03398148|141334935|SUPERIORITY||Adjusted Risk Difference|14.0|||<|0.0001|TWO_SIDED|95.0|10.0|18.0||Type I error rate control.|Cochran-Mantel-Haenszel|Stratified by Advanced Therapy-IR status (yes vs no), Baseline steroid use (yes vs. no) and Baseline Adapted Mayo Score (≤ 7, \> 7).||||18.0|10.0|<0.0001
70922173|NCT03398148|141334936|SUPERIORITY||Adjusted Risk Difference|18.7||||0.0028|TWO_SIDED|90.0|8.4|29.0||P-value ≤ 0.01|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||29.0|8.4|0.0028
70922174|NCT03398148|141334936|SUPERIORITY||Adjusted Risk Difference|8.4||||0.0968|TWO_SIDED|90.0|0.1|16.7||P-value ≤ 0.1|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||16.7|0.1|0.0968
70922175|NCT03398148|141334936|SUPERIORITY||Adjusted Risk Difference|10.5||||0.0512|TWO_SIDED|90.0|1.6|19.3||P-value ≤ 0.1|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||19.3|1.6|0.0512
70922176|NCT03398148|141334938|SUPERIORITY||Adjusted Risk Difference|23.9||||0.0022|TWO_SIDED|90.0|11.0|36.7||P-value ≤ 0.01|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||36.7|11.0|0.0022
70922177|NCT03398148|141334938|SUPERIORITY||Adjusted Risk Difference|28.4||||0.0002|TWO_SIDED|90.0|15.7|41.1||P-value ≤ 0.001|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||41.1|15.7|0.0002
70922178|NCT03398148|141334938|SUPERIORITY||Adjusted Risk Difference|33.8|||<|0.0001|TWO_SIDED|90.0|20.7|46.9||P-value ≤ 0.001|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||46.9|20.7|<0.0001
70922179|NCT03398148|141334939|SUPERIORITY||Adjusted Risk Difference|10.2||||0.1842|TWO_SIDED|90.0|-2.4|22.9|||Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||22.9|-2.4|0.1842
70976079|NCT04426695|141459913|SUPERIORITY|||||||0.05||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0500
70976080|NCT04426695|141459913|SUPERIORITY|||||||0.0663||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0663
70976081|NCT04426695|141459913|SUPERIORITY|||||||0.0229||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0229
70976082|NCT04426695|141459913|SUPERIORITY|||||||0.0208||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0208
70976083|NCT04426695|141459913|SUPERIORITY|||||||0.0388||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0388
70976084|NCT04426695|141459913|SUPERIORITY|||||||0.0092||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0092
70976085|NCT04426695|141459917|SUPERIORITY|||||||0.037|||||||stratified log-rank test|||||||0.0370
70976086|NCT04426695|141459917|SUPERIORITY|||||||0.1596|||||||stratified log-rank test|||||||0.1596
70976087|NCT04426695|141459917|SUPERIORITY|||||||0.0444|||||||stratified log-rank test|||||||0.0444
70976088|NCT04426695|141459917|SUPERIORITY|||||||0.1802|||||||stratified log-rank test|||||||0.1802
70976089|NCT04426695|141459917|SUPERIORITY|||||||0.0407|||||||stratified log-rank test|||||||0.0407
70976090|NCT04426695|141459917|SUPERIORITY|||||||0.0523|||||||stratified log-rank test|||||||0.0523
70976091|NCT04426695|141459918|SUPERIORITY|||||||0.0245|||||||ANCOVA|||||||0.0245
70976092|NCT04426695|141459918|SUPERIORITY|||||||0.0554|||||||ANCOVA|||||||0.0554
70976093|NCT04426695|141459918|SUPERIORITY|||||||0.0179|||||||ANCOVA|||||||0.0179
70976094|NCT04426695|141459918|SUPERIORITY|||||||0.0035|||||||ANCOVA|||||||0.0035
70976095|NCT04426695|141459918|SUPERIORITY|||||||0.0003|||||||ANCOVA|||||||0.0003
70976096|NCT04426695|141459918|SUPERIORITY|||||||0.0002|||||||ANCOVA|||||||0.0002
70976097|NCT04426695|141459919|SUPERIORITY|||||||0.0013|||||||ANCOVA|||||||0.0013
70976098|NCT04426695|141459919|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.0010
70976099|NCT04426695|141459919|SUPERIORITY|||||||0.0002|||||||ANCOVA|||||||0.0002
70976100|NCT04426695|141459919|SUPERIORITY|||||||0.025|||||||ANCOVA|||||||0.0250
70976101|NCT04426695|141459919|SUPERIORITY|||||||0.0012|||||||ANCOVA|||||||0.0012
70976102|NCT04426695|141459919|SUPERIORITY|||||||0.0014|||||||ANCOVA|||||||0.0014
70976103|NCT04426695|141459920|SUPERIORITY|||||||0.0623|||||||MMRM|||Difference vs. Placebo by Day 29||||0.0623
70976104|NCT04426695|141459920|SUPERIORITY|||||||0.0203|||||||MMRM|||Difference vs. Placebo by Day 29||||0.0203
70976105|NCT04426695|141459920|SUPERIORITY|||||||0.0193|||||||MMRM|||Difference vs. Placebo by Day 29||||0.0193
70976106|NCT04426695|141459920|SUPERIORITY|||||||0.1206|||||||MMRM|||Difference vs. Placebo by Day 29||||0.1206
70976107|NCT04426695|141459920|SUPERIORITY|||||||0.0911|||||||MMRM|||Difference vs. Placebo by Day 29||||0.0911
70976108|NCT04426695|141459920|SUPERIORITY|||||||0.0645|||||||MMRM|||Difference vs. Placebo by Day 29||||0.0645
70976109|NCT04426695|141459921|SUPERIORITY|||||||0.0623|||||||MMRM|||Percent Difference vs. Placebo at Day 29||||0.0623
70976110|NCT04426695|141459921|SUPERIORITY|||||||0.0203|||||||MMRM|||Percent Difference vs. Placebo at Day 29||||0.0203
70976111|NCT04426695|141459921|SUPERIORITY|||||||0.0193|||||||MMRM|||Percent Difference vs. Placebo at Day 29||||0.0193
70976112|NCT04426695|141459921|SUPERIORITY|||||||0.1206|||||||MMRM|||Percent Difference vs. Placebo at Day 29||||0.1206
70976113|NCT04426695|141459921|SUPERIORITY|||||||0.0911|||||||MMRM|||Percent Difference vs. Placebo at Day 29||||0.0911
70976114|NCT04426695|141459921|SUPERIORITY|||||||0.0645|||||||MMRM|||Percent Difference vs. Placebo at Day 29||||0.0645
70976115|NCT04426695|141459922|SUPERIORITY|||||||0.0481||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0481
70976116|NCT04426695|141459922|SUPERIORITY|||||||0.988||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.9880
70976117|NCT04426695|141459922|SUPERIORITY|||||||0.2498||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2498
70976118|NCT04426695|141459922|SUPERIORITY|||||||1||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||1.0000
70976119|NCT04426695|141459922|SUPERIORITY|||||||0.0457||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0457
70976120|NCT04426695|141459922|SUPERIORITY|||||||0.2153||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2153
70976121|NCT04426695|141459923|SUPERIORITY|||||||0.0811||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0811
70976122|NCT04426695|141459923|SUPERIORITY|||||||0.6701||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.6701
70976123|NCT04426695|141459923|SUPERIORITY|||||||0.2006||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2006
70976124|NCT04426695|141459923|SUPERIORITY|||||||0.3313||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3313
70976125|NCT04426695|141459923|SUPERIORITY|||||||0.5542||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.5542
70976126|NCT04426695|141459923|SUPERIORITY|||||||0.2214||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2214
70976127|NCT04426695|141459924|SUPERIORITY|||||||0.0389||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0389
70976128|NCT04426695|141459924|SUPERIORITY|||||||0.5208||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.5208
70976129|NCT04426695|141459924|SUPERIORITY|||||||0.1079||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1079
70976130|NCT04426695|141459924|SUPERIORITY|||||||0.3315||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3315
70976131|NCT04426695|141459924|SUPERIORITY|||||||0.5797||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.5797
70976132|NCT04426695|141459924|SUPERIORITY|||||||0.3036||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3036
70976133|NCT04426695|141459925|SUPERIORITY|||||||0.0364||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0364
70976134|NCT04426695|141459925|SUPERIORITY|||||||0.2795||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2795
70976135|NCT04426695|141459925|SUPERIORITY|||||||0.0588||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0588
70976136|NCT04426695|141459925|SUPERIORITY|||||||0.0364||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0364
70976137|NCT04426695|141459925|SUPERIORITY|||||||0.2795||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2795
70976138|NCT04426695|141459925|SUPERIORITY|||||||0.0588||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0588
70976139|NCT04426695|141459926|SUPERIORITY|||||||0.2635||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2635
71034176|NCT01667679|141578061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.052||0.4031|TWO_SIDED|95.0|-0.15|0.06|||ANCOVA||120 minutes post-dose|||0.06|-0.15|0.4031
71034177|NCT01667679|141578062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.019||0.0181|TWO_SIDED|95.0|-0.08|-0.01|||ANCOVA||10 minutes post-dose|||-0.01|-0.08|0.0181
71034178|NCT01667679|141578062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.026||0.0003|TWO_SIDED|95.0|-0.14|-0.04|||ANCOVA||15 minutes post-dose|||-0.04|-0.14|0.0003
71034179|NCT01667679|141578062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|-0.23|-0.09|||ANCOVA||30 minutes post-dose|||-0.09|-0.23|< 0.0001
71095726|NCT00762177|141699872|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70976140|NCT04426695|141459926|SUPERIORITY|||||||0.8013||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.8013
70976141|NCT04426695|141459926|SUPERIORITY|||||||0.416||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.4160
70976142|NCT04426695|141459926|SUPERIORITY|||||||0.2194||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2194
70976143|NCT04426695|141459926|SUPERIORITY|||||||0.324||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3240
70976144|NCT04426695|141459926|SUPERIORITY|||||||0.1981||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1981
70976145|NCT00559273|141459944|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||The p-value was the probability that the number of responders is greater than or equal to the observed number, although the true response rate was smaller or equal to 60%. Null hypothesis (H0): p-value \<=0.6; alternate hypothesis (H1): p-value \>0.6.||||<0.0001
70976146|NCT00559273|141459944|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||The p-value was the probability that the number of responders is greater than or equal to the observed number, although the true response rate was smaller or equal to 60%. Null hypothesis (H0): p-value \<=0.6; alternate hypothesis (H1): p-value \>0.6.||||<0.0001
70976147|NCT00559273|141459945|NON_INFERIORITY_OR_EQUIVALENCE|MIRCERA treatment was regarded as non-inferior to the darbepoetin alfa reference group if the lower limit of the CI was greater than -0.75 g/dL.|Adjusted Mean Difference|-0.036|STANDARD_ERROR_OF_MEAN|0.1097|<|0.0001|TWO_SIDED|95.0|-0.252|0.18|||ANCOVA|||||0.180|-0.252|<0.0001
71095727|NCT00762177|141699873|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70976148|NCT03653390|141459969|SUPERIORITY||||||<|0.01|||||||ANOVA|The ANOVA was conducted on the change scores from baseline to 6 months.||||||<0.01
70976149|NCT03653390|141459969|SUPERIORITY||Mean Difference (Net)|-1.24||||0.11|TWO_SIDED|95.0|-2.71|0.22|||Tukey's HSD test|This test inherently adjusts for multiple comparisons.|Difference is calculated as Wellness Education - EnhanceWellness for Disability|||0.22|-2.71|0.11
70976150|NCT03653390|141459969|SUPERIORITY||Mean Difference (Net)|-2.4|||<|0.01|TWO_SIDED|95.0|-3.85|-0.95|||Tukey's HSD test|This test inherently adjusts for multiple comparisons.|Difference is calculated as Control - EnhanceWellness for Disability|||-0.95|-3.85|<0.01
70976151|NCT03653390|141459969|SUPERIORITY||Mean Difference (Net)|-1.16||||0.16|TWO_SIDED|95.0|-2.64|0.32|||Tukey's HSD test|This test inherently adjusts for multiple comparisons.|Difference is calculated as Control - Wellness Education|||0.32|-2.64|0.16
70976152|NCT03653390|141459970|SUPERIORITY||||||<|0.01|||||||ANOVA|The ANOVA was conducted on the change scores from baseline to 6 months.||||||<0.01
70976153|NCT03653390|141459970|SUPERIORITY||Mean Difference (Net)|-2.18||||0.018|TWO_SIDED|95.0|-4.05|-0.3||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Wellness Education - EnhanceWellness for Disability|||-0.30|-4.05|0.018
70976154|NCT03653390|141459970|SUPERIORITY||Mean Difference (Net)|-2.26||||0.012|TWO_SIDED|95.0|-4.12|-0.41||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Control - EnhanceWellness for Disability|||-0.41|-4.12|0.012
70976155|NCT03653390|141459970|SUPERIORITY||Mean Difference (Net)|-0.08||||0.99|TWO_SIDED|95.0|-1.98|1.81||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Control - Wellness Education|||1.81|-1.98|0.99
70976156|NCT03653390|141459971|SUPERIORITY|||||||0.382|||||||ANOVA|The ANOVA was conducted on the change scores from baseline to 3 months.||||||0.382
70976157|NCT03653390|141459972|SUPERIORITY|||||||0.29|||||||ANOVA|The ANOVA was conducted on the change scores from baseline to 3 months.||||||0.29
71095728|NCT00762177|141699874|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71095729|NCT00762177|141699875|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70976158|NCT03653390|141459973|SUPERIORITY|||||||0.057|||||||ANOVA|The ANOVA was conducted on the change scores from baseline to 3 months.||||||0.057
70976159|NCT03653390|141459974|SUPERIORITY|||||||0.21|||||||ANOVA|The ANOVA was conducted on the change in number of trips from baseline to 12 months.||||||0.21
70976160|NCT03653390|141459975|SUPERIORITY|||||||0.79|||||||ANOVA|The ANOVA was conducted on the change in radius of gyration from baseline to 12 months.||||||0.79
70976161|NCT03653390|141459976|SUPERIORITY|||||||0.26|||||||ANOVA|The ANOVA was conducted on the change in number of trips from baseline to 12 months.||||||0.26
70976162|NCT03653390|141459977|SUPERIORITY||||||<|0.01|||||||ANOVA|The ANOVA was conducted on the change in minutes from baseline to 12 months.||||||<0.01
70976163|NCT03653390|141459977|SUPERIORITY||Mean Difference (Net)|-28.7||||0.57|TWO_SIDED|95.0|-95.7|38.4||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Wellness Education - EnhanceWellness for Disability|||38.4|-95.7|0.57
70976164|NCT03653390|141459977|SUPERIORITY||Mean Difference (Net)|66.6||||0.048|TWO_SIDED|95.0|0.56|132.6||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Control - EnhanceWellness for Disability|||132.6|0.56|0.048
71095730|NCT00762177|141699876|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70976165|NCT03653390|141459977|SUPERIORITY||Mean Difference (Net)|95.3|||<|0.01|TWO_SIDED|95.0|31.8|158.7||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Control - Wellness Education|||158.7|31.8|<0.01
71034180|NCT01667679|141578062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.043||0.0001|TWO_SIDED|95.0|-0.25|-0.08|||ANCOVA||45 minutes post-dose|||-0.08|-0.25|0.0001
71034181|NCT01667679|141578062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.047||0.0006|TWO_SIDED|95.0|-0.26|-0.07|||ANCOVA||60 minutes post-dose|||-0.07|-0.26|0.0006
71034182|NCT01667679|141578062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.048||0.0189|TWO_SIDED|95.0|-0.21|-0.02|||ANCOVA||90 minutes post-dose|||-0.02|-0.21|0.0189
71034183|NCT01667679|141578062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.05||0.1704|TWO_SIDED|95.0|-0.17|0.03|||ANCOVA||120 minutes post-dose|||0.03|-0.17|0.1704
71034184|NCT02777580|141578092|OTHER|||||||0.05|||||||Chi-squared|||||||0.05
71034185|NCT02777580|141578093|OTHER||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.62|1.48||||||||1.48|0.62|
71034186|NCT02777580|141578094|OTHER||Risk Ratio (RR)|4.57|||||TWO_SIDED|95.0|0.58|35.8||||||||35.8|0.58|
71034187|NCT02777580|141578095|OTHER||Risk Ratio (RR)|1.27|||||TWO_SIDED|95.0|0.25|6.48||||||||6.48|0.25|
71034188|NCT05630885|141578241|SUPERIORITY||Slope|0.984||||0.65|TWO_SIDED|95.0|0.916|1.056||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use. Analysis used multiple imputation for missing data.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale and rounded to 3 decimal places. It reflects the relative geometric mean fold-change in the TBR from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes arterial inflammation in the MDS of the index vessel, adjusting for statin-use. The study was powered to detect a between-group difference of 0.046 in log10 MDS TBR (10% relative fold-change), assuming a null difference of 0 in log10 MDS TBR (a ratio of 1 in absolute-scale), a standard deviation of 0.065 of change in log10 TBR, and 75 evaluable participants.||1.056|0.916|0.65
71034189|NCT05630885|141578241|OTHER|Statistical test for interaction.||||||0.4||||||P-value for modification of the CVC treatment effect by subgroups defined by statin-use is presented. A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use and its interaction with treatment. Analysis used multiple imputation for missing data.||Evaluates whether CVC, compared to placebo, changes arterial inflammation in the MDS of the index vessel differently by statin-use at study entry (use versus no-use).||||0.40
71034190|NCT05630885|141578241|OTHER|Statistical test for interaction.||||||0.63||||||P-value for modification of the CVC treatment effect by subgroups defined by sex is presented. A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for sex (F vs M) and its interaction with treatment. Analysis used multiple imputation for missing data.||Evaluates whether CVC, compared to placebo, changes arterial inflammation in the MDS of the index vessel differently by sex (female versus male).||||0.63
71034191|NCT05630885|141578241|OTHER|Statistical test for interaction.||||||0.71||||||P-value for modification of the CVC treatment effect by subgroups defined by race is presented. A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for race and its interaction with treatment. Analysis used multiple imputation for missing data.||Evaluates whether CVC, compared to placebo, changes arterial inflammation in the MDS of the index vessel differently by race (Black/African-American versus Non-Black/African-American).||||0.71
71034192|NCT05630885|141578242|SUPERIORITY||Slope|0.996||||0.91|TWO_SIDED|95.0|0.93|1.067||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale and rounded to 3 decimal places. It reflects the relative geometric mean fold-change in the TBR from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes arterial inflammation in the aorta adjusting for statin-use.||1.067|0.930|0.91
71034193|NCT05630885|141578242|SUPERIORITY||Slope|0.98||||0.64|TWO_SIDED|95.0|0.901|1.066||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale and rounded to 3 decimal places. It reflects the relative geometric mean fold-change in the TBR from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes arterial inflammation in the right and left carotid arteries adjusting for statin-use.||1.066|0.901|0.64
71034194|NCT05630885|141578243|SUPERIORITY||Slope|1.01||||0.79|TWO_SIDED|95.0|0.939|1.087||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale and rounded to 3 decimal places. It reflects the relative geometric mean fold-change in the SUV from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes arterial inflammation in the aorta adjusting for statin-use.||1.087|0.939|0.79
71034195|NCT05630885|141578243|SUPERIORITY||Slope|1.017||||0.69|TWO_SIDED|95.0|0.935|1.106||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale and rounded to 3 decimal places. It reflects the relative geometric mean fold-change in the SUV from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes arterial inflammation in the right and left carotid arteries adjusting for statin-use.||1.106|0.935|0.69
70976166|NCT03653390|141459978|SUPERIORITY||||||<|0.01|||||||ANOVA|The ANOVA was conducted on the change scores from baseline to 12 months.||||||<0.01
70976167|NCT03653390|141459978|SUPERIORITY||Mean Difference (Net)|-1.55||||0.028|TWO_SIDED|95.0|-2.97|-0.13||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Wellness Education - EnhanceWellness for Disability|||-0.13|-2.97|0.028
70976168|NCT03653390|141459978|SUPERIORITY||Mean Difference (Net)|-2.15|||<|0.01|TWO_SIDED|95.0|-3.55|-0.75|||Tukey's HSD test||Difference is calculated as Control - EnhanceWellness for Disability|||-0.75|-3.55|<0.01
70976169|NCT03653390|141459978|SUPERIORITY||Mean Difference (Net)|-0.6||||0.59|TWO_SIDED|95.0|-2.03|0.83||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Control - Wellness Education|||0.83|-2.03|0.59
70976170|NCT02769728|141460018|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||The threshold for statistical significance was p = 0.05||||0.001
70976171|NCT02769728|141460019|SUPERIORITY|||||||0.081||||||The threshold for statistical significance was p = 0.05|Friedman test|||||||0.081
70976172|NCT02769728|141460020|SUPERIORITY|||||||0.114||||||The threshold for statistical significance was p = 0.05|Friedman test|||||||0.114
70976173|NCT02769728|141460021|SUPERIORITY|||||||0.021||||||The threshold for statistical significance was p = 0.05|Friedman test|||||||0.021
70976174|NCT02769728|141460022|SUPERIORITY|||||||1||||||The threshold for statistical significance was p = 0.05|Friedman test|||||||1.00
70976175|NCT01552681|141460023|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED|||||P-value is testing for treatment effect using an analysis of covariance with adjustments for screening stimulated salivary flow.|ANCOVA|||Missing Week 24 assessments were imputed by carrying forward the last observed post-baseline value.||||0.33
70976176|NCT02532855|141460131|NON_INFERIORITY|For the primary hypothesis, sitagliptin will be considered non-inferior to dapagliflozin if the upper bound of the two-sided 95% confidence interval (CI) of the between-group difference in least squares mean change from baseline in A1C (sitagliptin minus dapagliflozin) is less than 0.3% (the non-inferiority margin). Longitudinal data analysis (LDA), Antihyperglycemic agent (AHA), Least squares means (LSM)|Difference in LSM (Sit. - Dap.)|-0.15|||||TWO_SIDED|95.0|-0.26|-0.04||||LDA model including terms for treatment, time, background AHA, the interaction of time and background AHA, and the interaction of time by treatment.||||-0.04|-0.26|
70976177|NCT02532855|141460131|SUPERIORITY||Difference in LSM (Sit. - Dap.)|-0.15||||0.006|TWO_SIDED|95.0|-0.26|-0.04|||Longitudinal data analysis|LDA model including terms for treatment, time, background AHA, the interaction of time and background AHA, and the interaction of time by treatment.||||-0.04|-0.26|0.006
70976178|NCT02532855|141460132|OTHER||Difference in % (Sit. - Dap.)|-2.8|||||TWO_SIDED|95.0|-10.7|5.1||||Miettinen \& Nurminen method||||5.1|-10.7|
70976179|NCT02532855|141460133|OTHER||Difference in % (Sit. - Dap.)|0.0|||||TWO_SIDED|95.0|-3.0|3.0||||Miettinen \& Nurminen method||||3.0|-3.0|
70976180|NCT02532855|141460134|SUPERIORITY||Difference in LSM (Sit. - Dap.)|-5.7||||0.138|TWO_SIDED|95.0|-13.3|1.8|||LDA|LDA model including terms for treatment, time, background AHA, the interaction of time and background AHA, and the interaction of time by treatment.||||1.8|-13.3|0.138
70976181|NCT02532855|141460135|SUPERIORITY||Difference in the LSM (Sit. - Dap.)|-3.4|||||TWO_SIDED|95.0|-12.1|5.3||||The ANCOVA model included terms for treatment, background AHA, and the baseline 2-hour PPG value as a covariate.||||5.3|-12.1|
70976182|NCT02532855|141460136|SUPERIORITY||Difference in the LSM (Sit. - Dap.)|-4.4|||||TWO_SIDED|95.0|-10.1|1.4||||The ANCOVA model included terms for treatment, background AHA, and the baseline glucagon AUC value as a covariate.||||1.4|-10.1|
70976183|NCT02532855|141460137|SUPERIORITY||Difference in the LSM (Sit. - Dap.)|4.9|||||TWO_SIDED|95.0|-12.2|22.0||||The ANCOVA model included terms for treatment, background AHA, and the baseline insulin AUC value as a covariate.||||22.0|-12.2|
70976184|NCT02532855|141460138|SUPERIORITY||Difference in the LSM (Sit. - Dap.)|0.6|||||TWO_SIDED|95.0|-0.1|1.3||||The ANCOVA model included terms for treatment, background AHA, and the baseline insulin AUC to glucagon AUC ratio value as a covariate.||||1.3|-0.1|
70976185|NCT02532855|141460139|OTHER|The percentage of participants was estimated using standard multiple imputation techniques from LDA model including terms for treatment, time, background AHA, the interaction of time and background AHA, and the interaction of time by treatment.|Difference in % (Sit. - Dap.)|15.5|||||TWO_SIDED|95.0|7.7|23.2||||Miettinen and Nurminen (M\&N) method with multiple imputation from a LDA Model.||||23.2|7.7|
70976186|NCT02532855|141460140|SUPERIORITY||Difference in the LSM (Sit. - Dap.)|3.5|||||TWO_SIDED|95.0|-1.2|8.3||||LDA model including terms for treatment, time, background AHA, the interaction of time and background AHA, and the interaction of time by treatment.||||8.3|-1.2|
70976187|NCT01960855|141460141|OTHER||||||=|0.033|||||||Chi-squared|||||||= 0.033
70976188|NCT01960855|141460141|OTHER||||||=|0.004|||||||Chi-squared|||||||= 0.004
70976189|NCT01960855|141460141|OTHER||||||<|0.001|||||||Chi-squared|||||||< 0.001
70976190|NCT01960855|141460141|OTHER||||||<|0.001|||||||Chi-squared|||||||< 0.001
70976191|NCT01960855|141460142|OTHER||||||=|0.364|||||||Chi-squared|||||||= 0.364
70976192|NCT01960855|141460142|OTHER||||||=|0.014|||||||Chi-squared|||||||= 0.014
70976193|NCT01960855|141460142|OTHER||||||=|0.003|||||||Chi-squared|||||||= 0.003
70976194|NCT01960855|141460142|OTHER||||||=|0.008|||||||Chi-squared|||||||= 0.008
70976195|NCT01960855|141460143|OTHER||||||=|0.093|||||||Chi-squared|||||||= 0.093
70976196|NCT01960855|141460143|OTHER||||||<|0.001|||||||Chi-squared|||||||< 0.001
70976197|NCT01960855|141460143|OTHER||||||=|0.004|||||||Chi-squared|||||||= 0.004
70976198|NCT01960855|141460143|OTHER||||||=|0.004|||||||Chi-squared|||||||= 0.004
70976199|NCT01960855|141460144|OTHER||||||=|0.366|||||||Chi-squared|||||||= 0.366
70976200|NCT01960855|141460144|OTHER||||||=|0.17|||||||Chi-squared|||||||= 0.17
70976201|NCT01960855|141460144|OTHER||||||=|0.003|||||||Chi-squared|||||||= 0.003
70976202|NCT01960855|141460144|OTHER||||||=|0.028|||||||Chi-squared|||||||= 0.028
70976203|NCT01960855|141460145|OTHER||||||=|0.126|||||||Chi-squared|||||||= 0.126
70976204|NCT01960855|141460145|OTHER||||||=|0.072|||||||Chi-squared|||||||= 0.072
70976205|NCT01960855|141460145|OTHER||||||=|0.012|||||||Chi-squared|||||||= 0.012
70976206|NCT01960855|141460145|OTHER||||||=|0.021|||||||Chi-squared|||||||= 0.021
70976207|NCT02058147|141460146|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|95.0|-0.898|-0.665||Threshold for significance ≤0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Lixisenatide|Analysis was performed using Mixed-effect model with repeated measures (MMRM) with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline HbA1c value-by-visit interaction as a covariate.||-0.665|-0.898|<0.0001
70976208|NCT02058147|141460146|NON_INFERIORITY_OR_EQUIVALENCE|Predefined non-inferiority margin of 0.3%.|LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.048|||TWO_SIDED|95.0|-0.384|-0.194|||Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin glargine|Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline HbA1c value-by-visit interaction as a covariate.||-0.194|-0.384|
70976209|NCT02058147|141460146|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001|TWO_SIDED|95.0|-0.384|-0.194||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin glargine|Test of superiority was also performed as a secondary endpoint according to hierarchical testing procedure. Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline HbA1c value-by-visit interaction, as a covariate.||-0.194|-0.384|<0.0001
70976210|NCT02058147|141460147|SUPERIORITY_OR_OTHER||Difference in percentage|40.61|||<|0.0001|TWO_SIDED|95.0|33.63|47.59||Threshold for significance ≤0.05.|Cochran-Mantel-Haenszel||HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs Lixisenatide.|"HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs Lixisenatide.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of second OAD use at screening. This analysis was out of testing order."||47.59|33.63|<0.0001
70976211|NCT02058147|141460147|SUPERIORITY_OR_OTHER||Difference in percentage|36.38|||<|0.0001|TWO_SIDED|95.0|29.81|42.95||Threshold for significance ≤ 0.05.|Cochran-Mantel-Haenszel||HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Lixisenatide.|"HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Lixisenatide.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of second OAD use at screening. This analysis was out of testing order."||42.95|29.81|<0.0001
70976212|NCT02058147|141460147|SUPERIORITY_OR_OTHER||Difference in percentage|14.31|||<|0.0001|TWO_SIDED|95.0|8.37|20.25||Threshold for significance ≤ 0.05.|Cochran-Mantel-Haenszel||HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs Insulin glargine.|"HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs Insulin glargine.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of second OAD use at screening. This analysis was out of testing order."||20.25|8.37|<0.0001
70976213|NCT02058147|141460147|SUPERIORITY_OR_OTHER||Difference in percentage|16.35|||<|0.0001|TWO_SIDED|95.0|10.13|22.58||Threshold for significance ≤ 0.05.|Cochran-Mantel-Haenszel||HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Insulin glargine.|"HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Insulin glargine.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of second OAD use at screening. This analysis was out of testing order."||22.58|10.13|<0.0001
71008494|NCT02355665|141524902|SUPERIORITY||Estimated Mean Difference|-0.14||||0.392|TWO_SIDED|95.0|-0.47|0.2||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of restlessness between treatments. The alternative hypothesis was a difference in distribution of the ratings of restlessness between treatments.||0.20|-0.47|0.392
71008495|NCT02355665|141524903|SUPERIORITY||Estimated Mean Difference|-0.23||||0.179|TWO_SIDED|95.0|-0.59|0.13||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of restlessness between treatments. The alternative hypothesis was a difference in distribution of the ratings of restlessness between treatments.||0.13|-0.59|0.179
71008496|NCT02355665|141524904|SUPERIORITY||Estimated Mean Difference|0.01||||0.925|TWO_SIDED|95.0|-0.44|0.47||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of difficulty concentrating between treatments. The alternative hypothesis was a difference in distribution of the ratings of difficulty concentrating between treatments.||0.47|-0.44|0.925
71008497|NCT02355665|141524905|SUPERIORITY||Estimated Mean Difference|-0.21||||0.325|TWO_SIDED|95.0|-0.66|0.24||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of difficulty concentrating between treatments. The alternative hypothesis was a difference in distribution of the ratings of difficulty concentrating between treatments.||0.24|-0.66|0.325
71008498|NCT02355665|141524906|SUPERIORITY||Estimated Mean Difference|0.13||||0.891|TWO_SIDED|95.0|-0.24|0.51||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of difficulty concentrating between treatments. The alternative hypothesis was a difference in distribution of the ratings of difficulty concentrating between treatments.||0.51|-0.24|0.891
71008499|NCT02355665|141524907|SUPERIORITY||Estimated Mean Difference|-0.11||||0.721|TWO_SIDED|95.0|-0.48|0.25||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of difficulty concentrating between treatments. The alternative hypothesis was a difference in distribution of the ratings of difficulty concentrating between treatments.||0.25|-0.48|0.721
70976214|NCT02058147|141460148|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.13|STANDARD_ERROR_OF_MEAN|0.185|<|0.0001|TWO_SIDED|95.0|-2.498|-1.77||Threshold for significance ≤0.05. The hierarchical testing continued only when primary hypotheses (superiority: FRC to lixisenatide; non-inferiority: FRC to insulin glargine for HbA1c) was statistically significant.|ANCOVA||Insulin Glargine/Lixisenatide FRC vs Insulin glargine.|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0,≥8.0%), randomization strata of second OAD use at screening \& country as fixed effects \& baseline plasma glucose excursion value as a covariate. Hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially per pre-specified order.||-1.77|-2.498|<0.0001
70976215|NCT02058147|141460149|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.891|-0.91||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline body weight value-by-visit interaction as a covariate.||-0.91|-1.891|<0.0001
70976216|NCT02058147|141460150|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.96|STANDARD_ERROR_OF_MEAN|0.144|<|0.0001|TWO_SIDED|95.0|-2.246|-1.682||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Lixisenatide|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline FPG value-by-visit interaction as a covariate.||-1.682|-2.246|<0.0001
70976217|NCT02058147|141460151|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.124|<|0.0001|TWO_SIDED|95.0|-1.645|-1.158||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Lixisenatide|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline 7-point SMPG value-by-visit interaction as a covariate.||-1.158|-1.645|<0.0001
70976218|NCT02058147|141460151|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.101|<|0.0001|TWO_SIDED|95.0|-0.892|-0.495||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline 7-point SMPG value-by-visit interaction, as a covariate.||-0.495|-0.892|<0.0001
70976219|NCT02058147|141460152|SUPERIORITY_OR_OTHER||Difference in percentage|18.08|||<|0.0001|TWO_SIDED|95.0|12.15|24.01||Threshold for significance ≤ 0.05.|Cochran-Mantel-Haenszel||Insulin Glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8%, ≥8%) and randomization strata of second OAD use at screening.||24.01|12.15|<0.0001
70976220|NCT02058147|141460153|SUPERIORITY_OR_OTHER||Difference in percentage|12.98|||<|0.0001|TWO_SIDED|95.0|7.5|18.45||Threshold for significance ≤ 0.05.|Cochran-Mantel-Haenszel||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of second OAD use at screening.||18.45|7.5|< 0.0001
70976221|NCT02058147|141460154|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.99||0.4857|TWO_SIDED|95.0|-2.632|1.252||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects.||1.252|-2.632|0.4857
70976222|NCT01162421|141460188|SUPERIORITY_OR_OTHER||Difference in percentage|-1.3||||0.907|TWO_SIDED|95.0|-23.4|20.8|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||||20.8|-23.4|0.907
70976223|NCT01162421|141460189|SUPERIORITY_OR_OTHER||Difference in percentage|3.2||||0.762|TWO_SIDED|95.0|-17.7|24.1|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||24.1|-17.7|0.762
70976224|NCT01162421|141460189|SUPERIORITY_OR_OTHER||Difference in percentage|-5.3||||0.65|TWO_SIDED|95.0|-28.1|17.5|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||17.5|-28.1|0.650
70976225|NCT01162421|141460190|SUPERIORITY_OR_OTHER||Least squares (LS) Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.382||0.027|TWO_SIDED|95.0|-1.62|-0.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P= 0.05.||Month 6||-0.10|-1.62|0.027
70976226|NCT01162421|141460190|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.46|STANDARD_ERROR_OF_MEAN|0.667||0.033|TWO_SIDED|95.0|-2.79|-0.12||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P= 0.05.||Month 12||-0.12|-2.79|0.033
70976227|NCT01162421|141460190|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.22|STANDARD_ERROR_OF_MEAN|1.403||0.12|TWO_SIDED|95.0|-5.05|0.6||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and baseline value as the covariate.|ANCOVA|||Month 24||0.60|-5.05|0.120
70976228|NCT01162421|141460191|SUPERIORITY_OR_OTHER||Difference in percentage|-11.7||||0.095|TWO_SIDED|95.0|-27.0|1.6||P-value is based on two sided Fisher's exact test.|Fisher Exact||Confidence interval is based on Wilson confidence limits.|||1.6|-27.0|0.095
70976229|NCT01162421|141460192|SUPERIORITY_OR_OTHER||Difference in percentage|12.1||||0.281|TWO_SIDED|95.0|-9.79|33.97|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||33.97|-9.79|0.281
70976230|NCT01162421|141460192|SUPERIORITY_OR_OTHER||Difference in percentage|27.0||||0.021|TWO_SIDED|95.0|4.98|48.93||The a priori threshold for statistical significance is P=0.05.|Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||48.93|4.98|0.021
70976231|NCT01162421|141460192|SUPERIORITY_OR_OTHER||Difference in percentage|6.7||||0.552|TWO_SIDED|95.0|-15.29|28.63|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||28.63|-15.29|0.552
70976232|NCT01162421|141460192|SUPERIORITY_OR_OTHER||Difference in percentage|-12.2||||0.281|TWO_SIDED|95.0|-34.04|9.72|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||9.72|-34.04|0.281
70976233|NCT01162421|141460192|SUPERIORITY_OR_OTHER||Difference in percentage|-14.4||||0.209|TWO_SIDED|95.0|-36.64|7.78|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||7.78|-36.64|0.209
70976234|NCT01162421|141460192|SUPERIORITY_OR_OTHER||Difference in percentage|-19.6||||0.091|TWO_SIDED|95.0|-41.74|2.62|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||2.62|-41.74|0.091
70976235|NCT01162421|141460193|SUPERIORITY_OR_OTHER||Difference in percentage|15.6||||0.148|TWO_SIDED|95.0|-5.05|36.26|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||36.26|-5.05|0.148
70976236|NCT01162421|141460193|SUPERIORITY_OR_OTHER||Difference in percentage|20.7||||0.06|TWO_SIDED|95.0|-0.14|41.61|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||41.61|-0.14|0.060
70976237|NCT01162421|141460193|SUPERIORITY_OR_OTHER||Difference in percentage|8.7||||0.451|TWO_SIDED|95.0|-13.85|31.29|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||31.29|-13.85|0.451
70976238|NCT01162421|141460193|SUPERIORITY_OR_OTHER||Difference in percentage|9.3||||0.413|TWO_SIDED|95.0|-12.82|31.43|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||31.43|-12.82|0.413
70976239|NCT01162421|141460193|SUPERIORITY_OR_OTHER||Difference in percentage|-7.3||||0.528|TWO_SIDED|95.0|-29.74|15.23|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||15.23|-29.74|0.528
70976240|NCT01162421|141460193|SUPERIORITY_OR_OTHER||Difference in percentage|-9.5||||0.399|TWO_SIDED|95.0|-31.61|12.56|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||12.56|-31.61|0.399
70976241|NCT01162421|141460194|SUPERIORITY_OR_OTHER||Difference in percentage|12.5||||0.111|TWO_SIDED|95.0|-1.7|27.06|||Fisher Exact|||Month 3||27.06|-1.70|0.111
70976242|NCT01162421|141460194|SUPERIORITY_OR_OTHER||Difference in percentage|19.6||||0.031|TWO_SIDED|95.0|2.74|36.53||The a priori threshold for statistical significance is P=0.05.|Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||36.53|2.74|0.031
70976243|NCT01162421|141460194|SUPERIORITY_OR_OTHER||Difference in percentage|2.8||||0.78|TWO_SIDED|95.0|-16.74|22.31|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||22.31|-16.74|0.780
70976244|NCT01162421|141460194|SUPERIORITY_OR_OTHER||Difference in percentage|16.5||||0.092|TWO_SIDED|95.0|-2.07|35.04|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||35.04|-2.07|0.092
70976245|NCT01162421|141460194|SUPERIORITY_OR_OTHER||Difference in percentage|10.8||||0.29|TWO_SIDED|95.0|-8.86|30.4|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||30.40|-8.86|0.290
70976246|NCT01162421|141460194|SUPERIORITY_OR_OTHER||Difference in percentage|-16.9||||0.116|TWO_SIDED|95.0|-37.86|4.01|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||4.01|-37.86|0.116
70976247|NCT01162421|141460195|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|1.18||0.004|TWO_SIDED|95.0|-5.9|-1.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.01.||Month 3||-1.2|-5.9|0.004
70976248|NCT01162421|141460195|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.12|<|0.001|TWO_SIDED|95.0|-6.8|-2.3||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.001.||Month 6||-2.3|-6.8|<0.001
70976249|NCT01162421|141460195|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|1.16||0.021|TWO_SIDED|95.0|-5.1|-0.4||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 9||-0.4|-5.1|0.021
70976250|NCT01162421|141460195|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.96||0.037|TWO_SIDED|95.0|-4.0|-0.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 12||-0.1|-4.0|0.037
70976251|NCT01162421|141460195|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|1.58||0.702|TWO_SIDED|95.0|-3.7|2.5||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18||2.5|-3.7|0.702
70976252|NCT01162421|141460195|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.15||0.644|TWO_SIDED|95.0|-2.8|1.8||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24||1.8|-2.8|0.644
70976253|NCT01162421|141460196|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.89||0.039|TWO_SIDED|95.0|-3.7|-0.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 3||-0.1|-3.7|0.039
70976254|NCT01162421|141460196|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.79|<|0.001|TWO_SIDED|95.0|-5.0|-1.8||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.001.||Month 6||-1.8|-5.0|<0.001
71034196|NCT05630885|141578244|SUPERIORITY||Slope|2.5||||0.49|TWO_SIDED|95.0|-4.6|9.6||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Model adjusted for statin-use.|Estimate reflects the relative mean change in fasting glucose from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes levels of fasting glucose adjusting for statin-use.||9.6|-4.6|0.49
71034197|NCT05630885|141578245|SUPERIORITY||Slope|1.07||||0.62|TWO_SIDED|95.0|0.81|1.43||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in fasting insulin from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes levels of fasting insulin adjusting for statin-use.||1.43|0.81|0.62
71034198|NCT05630885|141578245|SUPERIORITY||Slope|1.09||||0.61|TWO_SIDED|95.0|0.78|1.54||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in HOMA-IR from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes levels of HOMA-IR adjusting for statin-use.||1.54|0.78|0.61
71034199|NCT05630885|141578246|SUPERIORITY||Slope|0.97||||0.91|TWO_SIDED|95.0|0.62|1.52||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in hsCRP from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes levels of hsCRP adjusting for statin-use.||1.52|0.62|0.91
71034200|NCT05630885|141578246|SUPERIORITY||Slope|1.01||||0.94|TWO_SIDED|95.0|0.77|1.33||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in IL-6 from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes the levels of IL-6 adjusted for statin-use.||1.33|0.77|0.94
71034201|NCT05630885|141578246|SUPERIORITY||Slope|4.74|||<|0.001|TWO_SIDED|95.0|3.89|5.77||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in MCP-1 from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes the levels of MCP-1 adjusting for statin-use.||5.77|3.89|<0.001
71034202|NCT05630885|141578247|SUPERIORITY||Slope|-49.0||||0.38|TWO_SIDED|95.0|-158.0|60.0||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Model adjusted for statin-use.|Estimate reflects the relative mean change in sCD14 from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes levels of sCD14 adjusting for statin-use.||60|-158|0.38
71034203|NCT05630885|141578247|SUPERIORITY||Slope|-6.3||||0.88|TWO_SIDED|95.0|-87.0|75.0||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Model adjusted for statin-use.|Estimate reflects the relative mean change in sCD163 from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes the levels of sCD163 adjusting for statin-use.||75|-87|0.88
71034204|NCT05630885|141578248|SUPERIORITY||Slope|1.65|||<|0.001|TWO_SIDED|95.0|1.28|2.12||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in MIP-1 beta from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes the levels of MIP-1 beta adjusting for statin-use.||2.12|1.28|<0.001
71034205|NCT05630885|141578248|SUPERIORITY||Slope|1.02||||0.85|TWO_SIDED|95.0|0.82|1.28||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in RANTES from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes levels of RANTES adjusting for statin-use.||1.28|0.82|0.85
71034206|NCT03466866|141578276|SUPERIORITY||Incidence rate ratio|0.67||||0.12|TWO_SIDED|95.0|0.42|1.07|||Poisson regression|We adjusted for stratification variables, sex, baseline MOCA, number of medical conditions, PSQ Communication, and PSQ General satisfaction.||We used Poisson regression to model the number of outcome events as a function of randomization assignment, adjusting for the stratification variables and using follow-up time as the offset term. We calculated estimates of annual rates of the primary outcome and the adjusted estimate of the rate ratio. We evaluated the primary hypothesis by testing the null hypothesis that the rate ratio for randomization assignment equals 1.||1.07|.42|.12
71034207|NCT03466866|141578277|SUPERIORITY|General Satisfaction|Mean Difference (Final Values)|0.11||||0.502|TWO_SIDED|95.0|-0.22|0.45|||Regression, Linear|||We modeled PSQ- scores as continuous variables to estimate average change over time by treatment group. We used mixed effects linear regression with fixed effects for time (baseline, and months 6 and 12), randomization assignment, and time by randomization interaction. A random intercept term and an appropriate covariance structure was used to account for correlation among repeated measurements.||.45|-.22|.502
71034208|NCT03466866|141578278|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.23|TWO_SIDED|95.0|0.16|0.69|||ANCOVA|||Analysis of covariance was performed with Number of Quality Metrics as the dependent variable, treatment arm as the main independent variable of interest and the stratification variables as adjusting variables.||.69|.16|.23
70976255|NCT01162421|141460196|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.81||0.008|TWO_SIDED|95.0|-3.8|-0.6||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.01.||Month 9||-0.6|-3.8|0.008
70976256|NCT01162421|141460196|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.71||0.028|TWO_SIDED|95.0|-3.0|-0.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 12||-0.2|-3.0|0.028
70976257|NCT01162421|141460196|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.94||0.452|TWO_SIDED|95.0|-2.6|1.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18||1.2|-2.6|0.452
70976258|NCT01162421|141460196|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.77||0.343|TWO_SIDED|95.0|-2.3|0.8||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24||0.8|-2.3|0.343
70976259|NCT01162421|141460197|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|2.26||0.22|TWO_SIDED|95.0|-7.3|1.7||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 3||1.7|-7.3|0.220
70976260|NCT01162421|141460197|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|1.92|<|0.001|TWO_SIDED|95.0|-11.0|-3.3||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.001.||Month 6||-3.3|-11.0|<0.001
70976261|NCT01162421|141460197|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|1.87||0.05|TWO_SIDED|95.0|-7.5|0.0||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 9||0.0|-7.5|0.050
70976262|NCT01162421|141460197|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.95||0.725|TWO_SIDED|95.0|-4.6|3.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 12||3.2|-4.6|0.725
70976263|NCT01162421|141460197|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|2.31||0.837|TWO_SIDED|95.0|-5.1|4.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18||4.1|-5.1|0.837
70976264|NCT01162421|141460197|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.83||0.661|TWO_SIDED|95.0|-4.5|2.9||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24||2.9|-4.5|0.661
70976265|NCT01162421|141460198|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.29||0.156|TWO_SIDED|95.0|-4.4|0.7||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 3||0.7|-4.4|0.156
70976266|NCT01162421|141460198|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.08|<|0.001|TWO_SIDED|95.0|-6.1|-1.9||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.001.||Month 6||-1.9|-6.1|<0.001
70976267|NCT01162421|141460198|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|1.19||0.04|TWO_SIDED|95.0|-4.9|-0.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 9||-0.1|-4.9|0.040
70976268|NCT01162421|141460198|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.14||0.492|TWO_SIDED|95.0|-3.1|1.5||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 12||1.5|-3.1|0.492
70976269|NCT01162421|141460198|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|1.3||0.649|TWO_SIDED|95.0|-3.2|2.0||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18||2.0|-3.2|0.649
70976270|NCT01162421|141460198|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.11||0.464|TWO_SIDED|95.0|-3.0|1.4||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24||1.4|-3.0|0.464
70976271|NCT01162421|141460199|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.3|STANDARD_ERROR_OF_MEAN|5.08||0.018|TWO_SIDED|95.0|-22.5|-2.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 3||-2.2|-22.5|0.018
70976272|NCT01162421|141460199|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.5|STANDARD_ERROR_OF_MEAN|5.9|<|0.001|TWO_SIDED|95.0|-37.3|-13.7||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.001.||Month 6||-13.7|-37.3|<0.001
70976273|NCT01162421|141460199|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|5.84||0.113|TWO_SIDED|95.0|-21.0|2.3||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 9||2.3|-21.0|0.113
70976274|NCT01162421|141460199|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|5.72||0.544|TWO_SIDED|95.0|-14.9|7.9||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 12||7.9|-14.9|0.544
71034209|NCT03466866|141578279|SUPERIORITY||Mean Difference (Net)|4.45||||0.094|TWO_SIDED|95.0|-0.76|9.66|||Mixed Models Analysis|||We used mixed effects linear regression. Fixed effects included time (baseline, and months 6 and 12), randomization assignment, time by randomization interaction, and the three stratification variables. From the results of this model, we estimated the mean change from baseline to 6 months, 6 months to 12 months and baseline to 12 months within each treatment group. We then compared the change from baseline to 12 months between the two groups.||9.66|-.76|.094
70976275|NCT01162421|141460199|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|5.96||0.916|TWO_SIDED|95.0|-12.5|11.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18||11.2|-12.5|0.916
70976276|NCT01162421|141460199|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|5.86||0.983|TWO_SIDED|95.0|-11.8|11.6||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24||11.6|-11.8|0.983
70976277|NCT01162421|141460200|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|4.96||0.641|TWO_SIDED|95.0|-12.2|7.6||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||7.6|-12.2|0.641
70976278|NCT01162421|141460200|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|5.61||0.358|TWO_SIDED|95.0|-16.4|6.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||6.0|-16.4|0.358
70976279|NCT01162421|141460200|SUPERIORITY_OR_OTHER||LS Mean Difference|5.2|STANDARD_ERROR_OF_MEAN|5.58||0.352|TWO_SIDED|95.0|-5.9|16.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||16.4|-5.9|0.352
71034210|NCT00318461|141578300|NON_INFERIORITY_OR_EQUIVALENCE|"Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 1.8 mg+metformin was superior to placebo + metformin.~Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%."|Estimated treatment difference, LS Mean|-1.09|||<|0.0001||95.0|-1.3|-0.88|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.88|-1.30|<0.0001
71095731|NCT00762177|141699877|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||the tongue will be scrapped 5 times with the edge of a tongue depressor. The depressor is vortex in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar||||0.05
70976280|NCT01162421|141460200|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|5.28||0.99|TWO_SIDED|95.0|-10.5|10.6||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||10.6|-10.5|0.990
70976281|NCT01162421|141460200|SUPERIORITY_OR_OTHER||LS Mean Difference|6.4|STANDARD_ERROR_OF_MEAN|5.36||0.238|TWO_SIDED|95.0|-4.3|17.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||17.1|-4.3|0.238
70976282|NCT01162421|141460200|SUPERIORITY_OR_OTHER||LS Mean Difference|7.1|STANDARD_ERROR_OF_MEAN|5.54||0.207|TWO_SIDED|95.0|-4.0|18.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||18.1|-4.0|0.207
70976283|NCT01162421|141460201|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|5.28||0.85|TWO_SIDED|95.0|-11.5|9.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||9.5|-11.5|0.850
70976284|NCT01162421|141460201|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|5.49||0.129|TWO_SIDED|95.0|-19.4|2.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||2.5|-19.4|0.129
70976285|NCT01162421|141460201|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|5.62||0.937|TWO_SIDED|95.0|-10.8|11.6||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||11.6|-10.8|0.937
70976286|NCT01162421|141460201|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|5.59||0.67|TWO_SIDED|95.0|-13.5|8.8||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||8.8|-13.5|0.670
70976287|NCT01162421|141460201|SUPERIORITY_OR_OTHER||LS Mean Difference|5.4|STANDARD_ERROR_OF_MEAN|5.67||0.341|TWO_SIDED|95.0|-5.9|16.7||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||16.7|-5.9|0.341
71095732|NCT00762177|141699878|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70976288|NCT01162421|141460201|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|6.13||0.621|TWO_SIDED|95.0|-9.2|15.3||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||15.3|-9.2|0.621
70976289|NCT01162421|141460202|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|3.29||0.697|TWO_SIDED|95.0|-5.3|7.9||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||7.9|-5.3|0.697
71095733|NCT00762177|141699879|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70976290|NCT01162421|141460202|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|4.51||0.744|TWO_SIDED|95.0|-10.5|7.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||7.5|-10.5|0.744
70976291|NCT01162421|141460202|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|3.95||0.967|TWO_SIDED|95.0|-7.7|8.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||8.0|-7.7|0.967
70976292|NCT01162421|141460202|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|3.3||0.377|TWO_SIDED|95.0|-3.7|9.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||9.5|-3.7|0.377
70976293|NCT01162421|141460202|SUPERIORITY_OR_OTHER||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|3.5||0.122|TWO_SIDED|95.0|-1.5|12.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||12.4|-1.5|0.122
70976294|NCT01162421|141460202|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|3.42||0.49|TWO_SIDED|95.0|-4.4|9.2||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||9.2|-4.4|0.490
70976295|NCT01162421|141460203|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.27||0.102|TWO_SIDED|95.0|-1.0|0.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 3||0.1|-1.0|0.102
70976296|NCT01162421|141460203|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.29||0.003|TWO_SIDED|95.0|-1.5|-0.3||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.01.||Month 6||-0.3|-1.5|0.003
70976297|NCT01162421|141460203|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.29||0.214|TWO_SIDED|95.0|-0.9|0.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 9||0.2|-0.9|0.214
70976298|NCT01162421|141460203|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.27||0.339|TWO_SIDED|95.0|-0.8|0.3||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 12||0.3|-0.8|0.339
70976299|NCT01162421|141460203|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.973|TWO_SIDED|95.0|-0.6|0.6||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18||0.6|-0.6|0.973
70976300|NCT01162421|141460203|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.28||0.755|TWO_SIDED|95.0|-0.6|0.5||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24||0.5|-0.6|0.755
70976301|NCT01162421|141460204|SUPERIORITY_OR_OTHER||Difference in percentage|9.4||||0.316|TWO_SIDED|95.0|-7.09|25.13|||Fisher Exact|Two-sided Fisher Exact test.||Month 3||25.13|-7.09|0.316
70976302|NCT01162421|141460204|SUPERIORITY_OR_OTHER||Difference in percentage|24.5||||0.014|TWO_SIDED|95.0|6.09|42.85|||Chi-squared|P-value is based on two-sided Pearson's chi-square test. The a priori threshold for statistical significance is P=0.05.||Month 6||42.85|6.09|0.014
70976303|NCT01162421|141460204|SUPERIORITY_OR_OTHER||Difference in percentage|-3.2||||0.762|TWO_SIDED|95.0|-24.1|17.66|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||17.66|-24.10|0.762
70976304|NCT01162421|141460204|SUPERIORITY_OR_OTHER||Difference in percentage|13.0||||0.22|TWO_SIDED|95.0|-7.46|33.54|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||33.54|-7.46|0.220
70976305|NCT01162421|141460204|SUPERIORITY_OR_OTHER||Difference in percentage|-3.5||||0.747|TWO_SIDED|95.0|-24.9|17.86|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||17.86|-24.90|0.747
70976306|NCT01162421|141460204|SUPERIORITY_OR_OTHER||Difference in percentage|-4.4||||0.701|TWO_SIDED|95.0|-26.8|18.01|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||18.01|-26.80|0.701
70976307|NCT01162421|141460205|SUPERIORITY_OR_OTHER||Difference in percentage|10.5||||0.318|TWO_SIDED|95.0|-9.83|30.78|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||30.78|-9.83|0.318
70976308|NCT01162421|141460205|SUPERIORITY_OR_OTHER||Difference in percentage|22.7||||0.047|TWO_SIDED|95.0|1.03|44.39|||Chi-squared|P-value is based on two-sided Pearson's chi-square test. The a priori threshold for statistical significance is P=0.05.||Month 6||44.39|1.03|0.047
70976309|NCT01162421|141460205|SUPERIORITY_OR_OTHER||Difference in percentage|5.0||||0.668|TWO_SIDED|95.0|-17.74|27.71|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||27.71|-17.74|0.668
70976310|NCT01162421|141460205|SUPERIORITY_OR_OTHER||Difference in percentage|7.8||||0.5|TWO_SIDED|95.0|-14.88|30.56|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||30.56|-14.88|0.500
70976311|NCT01162421|141460205|SUPERIORITY_OR_OTHER||Difference in percentage|-2.7||||0.816|TWO_SIDED|95.0|-25.52|20.1|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||20.10|-25.52|0.816
70976312|NCT01162421|141460205|SUPERIORITY_OR_OTHER||Difference in percentage|-10.7||||0.358|TWO_SIDED|95.0|-33.38|11.99|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||11.99|-33.38|0.358
70976313|NCT01162421|141460206|SUPERIORITY_OR_OTHER||Difference in percentage|7.9||||0.444|TWO_SIDED|95.0|-12.17|28.0|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||28.00|-12.17|0.444
70976314|NCT01162421|141460206|SUPERIORITY_OR_OTHER||Difference in percentage|20.1||||0.076|TWO_SIDED|95.0|-1.53|41.83|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||41.83|-1.53|0.076
70976315|NCT01162421|141460206|SUPERIORITY_OR_OTHER||Difference in percentage|2.7||||0.816|TWO_SIDED|95.0|-20.1|25.52|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||25.52|-20.10|0.816
70976316|NCT01162421|141460206|SUPERIORITY_OR_OTHER||Difference in percentage|8.1||||0.485|TWO_SIDED|95.0|-14.61|30.87|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||30.87|-14.61|0.485
70976317|NCT01162421|141460206|SUPERIORITY_OR_OTHER||Difference in percentage|-2.7||||0.816|TWO_SIDED|95.0|-25.52|20.1|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||20.10|-25.52|0.816
70976318|NCT01162421|141460206|SUPERIORITY_OR_OTHER||Difference in percentage|-10.7||||0.358|TWO_SIDED|95.0|-33.38|11.99|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||11.99|-33.38|0.358
70976319|NCT01162421|141460207|SUPERIORITY_OR_OTHER||Difference in percentage|11.6||||0.316|TWO_SIDED|95.0|-10.84|33.99|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||33.99|-10.84|0.316
70976320|NCT01162421|141460207|SUPERIORITY_OR_OTHER||Difference in percentage|5.1||||0.63|TWO_SIDED|95.0|-15.43|25.54|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||25.54|-15.43|0.630
70976321|NCT01162421|141460207|SUPERIORITY_OR_OTHER||Difference in percentage|-0.4||||0.972|TWO_SIDED|95.0|-20.94|20.21|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||20.21|-20.94|0.972
70976322|NCT01162421|141460207|SUPERIORITY_OR_OTHER||Difference in percentage|-14.1||||0.186|TWO_SIDED|95.0|-34.83|6.7|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||6.70|-34.83|0.186
70976323|NCT01162421|141460207|SUPERIORITY_OR_OTHER||Difference in percentage|-12.6||||0.142|TWO_SIDED|95.0|-29.46|4.26|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||4.26|-29.46|0.142
70976324|NCT01162421|141460207|SUPERIORITY_OR_OTHER||Difference in percentage|-4.0||||0.727|TWO_SIDED|95.0|-20.34|11.52|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||11.52|-20.34|0.727
70976325|NCT01162421|141460208|SUPERIORITY_OR_OTHER||Difference in percentage|6.8||||0.486|TWO_SIDED|95.0|-9.21|22.22|||Fisher Exact|Two-sided Fisher Exact test.||||22.22|-9.21|0.486
70976326|NCT01162421|141460209|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.13||0.809|TWO_SIDED|95.0|-0.23|0.29||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||0.29|-0.23|0.809
70976327|NCT01162421|141460209|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.132||0.194|TWO_SIDED|95.0|-0.44|0.09||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||0.09|-0.44|0.194
70976328|NCT01162421|141460209|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.132||0.863|TWO_SIDED|95.0|-0.24|0.29||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||0.29|-0.24|0.863
70976329|NCT01162421|141460209|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.129||0.452|TWO_SIDED|95.0|-0.16|0.35||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||0.35|-0.16|0.452
70976330|NCT01162421|141460209|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.141||0.738|TWO_SIDED|95.0|-0.23|0.33||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||0.33|-0.23|0.738
70976331|NCT01162421|141460209|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.148||0.572|TWO_SIDED|95.0|-0.21|0.38||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||0.38|-0.21|0.572
70976332|NCT01162421|141460210|SUPERIORITY_OR_OTHER||Difference in percentage|-11.9||||0.299|TWO_SIDED|95.0|-34.05|10.31|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||10.31|-34.05|0.299
70976333|NCT01162421|141460210|SUPERIORITY_OR_OTHER||Difference in percentage|-3.0||||0.796|TWO_SIDED|95.0|-25.77|19.77|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||19.77|-25.77|0.796
70976334|NCT01162421|141460210|SUPERIORITY_OR_OTHER||Difference in percentage|7.0||||0.54|TWO_SIDED|95.0|-15.3|29.22|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||29.22|-15.30|0.540
70976335|NCT01162421|141460210|SUPERIORITY_OR_OTHER||Difference in percentage|-9.6||||0.392|TWO_SIDED|95.0|-31.39|12.19|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||12.19|-31.39|0.392
70976336|NCT01162421|141460210|SUPERIORITY_OR_OTHER||Difference in percentage|-3.3||||0.776|TWO_SIDED|95.0|-25.96|19.37|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||19.37|-25.96|0.776
70976337|NCT01162421|141460210|SUPERIORITY_OR_OTHER||Difference in percentage|-16.1||||0.166|TWO_SIDED|95.0|-38.64|6.4|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||6.40|-38.64|0.166
70976338|NCT01162421|141460211|SUPERIORITY_OR_OTHER||Difference in percentage|-10.9||||0.283|TWO_SIDED|95.0|-30.84|9.01|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||9.01|-30.84|0.283
70976339|NCT01162421|141460211|SUPERIORITY_OR_OTHER||Difference in percentage|7.9||||0.444|TWO_SIDED|95.0|-12.17|28.0|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||28.00|-12.17|0.444
70976340|NCT01162421|141460211|SUPERIORITY_OR_OTHER||Difference in percentage|1.6||||0.885|TWO_SIDED|95.0|-20.16|23.38|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||23.38|-20.16|0.885
70976341|NCT01162421|141460211|SUPERIORITY_OR_OTHER||Difference in percentage|-1.0||||0.931|TWO_SIDED|95.0|-22.54|20.64|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||20.64|-22.54|0.931
70976342|NCT01162421|141460211|SUPERIORITY_OR_OTHER||Difference in percentage|2.2||||0.836|TWO_SIDED|95.0|-18.63|23.03|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||23.03|-18.63|0.836
70976343|NCT01162421|141460211|SUPERIORITY_OR_OTHER||Difference in percentage|2.2||||0.836|TWO_SIDED|95.0|-18.63|23.03|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||23.03|-18.63|0.836
70976344|NCT01162421|141460212|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|2.25||0.699|TWO_SIDED|95.0|-3.6|5.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||5.4|-3.6|0.699
70976345|NCT01162421|141460212|SUPERIORITY_OR_OTHER||LS Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|2.45||0.261|TWO_SIDED|95.0|-2.1|7.7||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||7.7|-2.1|0.261
71095734|NCT00762177|141699880|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70976346|NCT01162421|141460212|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|2.36||0.514|TWO_SIDED|95.0|-6.2|3.2||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||3.2|-6.2|0.514
70976347|NCT01162421|141460212|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|2.5||0.283|TWO_SIDED|95.0|-7.7|2.3||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||2.3|-7.7|0.283
70976348|NCT01162421|141460212|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.75||0.461|TWO_SIDED|95.0|-7.5|3.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||3.4|-7.5|0.461
70976349|NCT01162421|141460212|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.78||0.703|TWO_SIDED|95.0|-6.6|4.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||4.5|-6.6|0.703
70976350|NCT01162421|141460213|SUPERIORITY_OR_OTHER||Difference in percentage|-1.1||||1|TWO_SIDED|95.0|-17.94|15.16|||Fisher Exact|Two-sided Fisher Exact test.||Month 3||15.16|-17.94|1.000
70976351|NCT01162421|141460213|SUPERIORITY_OR_OTHER||Difference in percentage|-6.4||||0.468|TWO_SIDED|95.0|-22.34|8.81|||Fisher Exact|Two-sided Fisher Exact test.||Month 6||8.81|-22.34|0.468
70976352|NCT01162421|141460213|SUPERIORITY_OR_OTHER||Difference in percentage|-11.9||||0.142|TWO_SIDED|95.0|-27.88|3.16|||Fisher Exact|Two-sided Fisher Exact test.||Month 9||3.16|-27.88|0.142
70976353|NCT01162421|141460213|SUPERIORITY_OR_OTHER||Difference in percentage|4.6||||0.712|TWO_SIDED|95.0|-11.08|19.83|||Fisher Exact|Two-sided Fisher Exact test.||Month 12||19.83|-11.08|0.712
70976354|NCT01162421|141460213|SUPERIORITY_OR_OTHER||Difference in percentage|7.2||||0.482|TWO_SIDED|95.0|-8.92|22.89|||Fisher Exact|Two-sided Fisher Exact test.||Month 18||22.89|-8.92|0.482
70976355|NCT01162421|141460213|SUPERIORITY_OR_OTHER||Difference in percentage|-6.2||||0.418|TWO_SIDED|95.0|-21.18|7.69|||Fisher Exact|Two-sided Fisher Exact test.||Month 24||7.69|-21.18|0.418
70976356|NCT01162421|141460214|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|5.86||0.453|TWO_SIDED|95.0|-16.3|7.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||7.4|-16.3|0.453
70976357|NCT01162421|141460214|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.9|STANDARD_ERROR_OF_MEAN|5.88||0.187|TWO_SIDED|95.0|-19.7|4.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||4.0|-19.7|0.187
70976358|NCT01162421|141460214|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|6.31||0.598|TWO_SIDED|95.0|-16.1|9.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||9.4|-16.1|0.598
70976359|NCT01162421|141460214|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|5.75||0.558|TWO_SIDED|95.0|-8.2|15.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||15.0|-8.2|0.558
70976360|NCT01162421|141460214|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|6.4||0.669|TWO_SIDED|95.0|-10.1|15.6||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||15.6|-10.1|0.669
70976361|NCT01162421|141460214|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|6.16||0.865|TWO_SIDED|95.0|-11.3|13.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||13.5|-11.3|0.865
70976362|NCT01162421|141460215|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.058||0.809|TWO_SIDED|95.0|-0.1|0.13||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||0.13|-0.10|0.809
70976363|NCT01162421|141460215|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.062||0.447|TWO_SIDED|95.0|-0.08|0.17||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||0.17|-0.08|0.447
70976364|NCT01162421|141460215|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.062||0.579|TWO_SIDED|95.0|-0.16|0.09||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||0.09|-0.16|0.579
70976365|NCT01162421|141460215|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.057||0.922|TWO_SIDED|95.0|-0.11|0.12||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||0.12|-0.11|0.922
70976366|NCT01162421|141460215|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.064||0.894|TWO_SIDED|95.0|-0.14|0.12||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||0.12|-0.14|0.894
70976367|NCT01162421|141460215|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.611|TWO_SIDED|95.0|-0.17|0.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||0.10|-0.17|0.611
70976368|NCT01162421|141460216|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|4.42||0.572|TWO_SIDED|95.0|-11.3|6.3||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||6.3|-11.3|0.572
70976369|NCT01162421|141460216|SUPERIORITY_OR_OTHER||LS Mean Difference|7.9|STANDARD_ERROR_OF_MEAN|5.15||0.13|TWO_SIDED|95.0|-2.4|18.2||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||18.2|-2.4|0.130
70976370|NCT01162421|141460216|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|5.26||0.649|TWO_SIDED|95.0|-12.9|8.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||8.1|-12.9|0.649
71095735|NCT00762177|141699881|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70976371|NCT01162421|141460216|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|4.8||0.579|TWO_SIDED|95.0|-12.3|6.9||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||6.9|-12.3|0.579
70976372|NCT01162421|141460216|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|5.03||0.826|TWO_SIDED|95.0|-11.1|8.9||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||8.9|-11.1|0.826
70976373|NCT01162421|141460216|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|5.72||0.675|TWO_SIDED|95.0|-13.8|9.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||9.0|-13.8|0.675
70976374|NCT01162421|141460217|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.57||0.458|TWO_SIDED|95.0|-2.0|4.3||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||4.3|-2.0|0.458
71034211|NCT00318461|141578300|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 1.8 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 1.8 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|-0.02|||<|0.0001||95.0|-0.19|0.15|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||0.15|-0.19|<0.0001
70976375|NCT01162421|141460217|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|1.76||0.419|TWO_SIDED|95.0|-4.9|2.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||2.1|-4.9|0.419
70976376|NCT01162421|141460217|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.42||0.692|TWO_SIDED|95.0|-2.3|3.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||3.4|-2.3|0.692
70976377|NCT01162421|141460217|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|1.69||0.357|TWO_SIDED|95.0|-1.8|5.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||5.0|-1.8|0.357
71034212|NCT00318461|141578300|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 1.2 mg+metformin was superior to placebo + metformin. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-1.06|||<|0.0001||95.0|-1.27|-0.85|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.85|-1.27|<0.0001
70976378|NCT01162421|141460217|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|1.67||0.42|TWO_SIDED|95.0|-2.0|4.7||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||4.7|-2.0|0.420
70976379|NCT01162421|141460217|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|1.58||0.38|TWO_SIDED|95.0|-1.8|4.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||4.5|-1.8|0.380
71095736|NCT00762177|141699882|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71095737|NCT00762177|141699883|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70976380|NCT01162421|141460218|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.28||0.046|TWO_SIDED|95.0|0.0|1.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 3||1.1|0.0|0.046
70976381|NCT01162421|141460218|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.27||0.003|TWO_SIDED|95.0|0.3|1.3||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.01.||Month 6||1.3|0.3|0.003
70976382|NCT01162421|141460218|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.24||0.204|TWO_SIDED|95.0|-0.2|0.8||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||0.8|-0.2|0.204
70976383|NCT01162421|141460218|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.227|TWO_SIDED|95.0|-0.2|0.7||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||0.7|-0.2|0.227
70976384|NCT01162421|141460218|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.23||0.86|TWO_SIDED|95.0|-0.4|0.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||0.5|-0.4|0.860
70976385|NCT01162421|141460218|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.22||0.476|TWO_SIDED|95.0|-0.3|0.6||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||0.6|-0.3|0.476
71095738|NCT00762177|141699884|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70976386|NCT02867761|141460234|SUPERIORITY||Odds Ratio (OR)|0.91||||0.65|TWO_SIDED|95.0|0.6|1.37|||Generalized Estimating Equation|||||1.37|0.60|0.65
70976387|NCT02867761|141460238|SUPERIORITY|||||||0.3|||||||Linear Mixed Effects Model|||||||0.30
70976388|NCT02867761|141460239|SUPERIORITY|||||||0.49|||||||Linear Mixed Effects Model|||||||0.49
70976389|NCT02867761|141460240|SUPERIORITY|||||||0.96|||||||Linear Mixed Effects Model|||||||0.96
70976390|NCT02867761|141460241|SUPERIORITY||||||<|0.001|||||||Linear Mixed Effects Model|||||||<0.001
70976391|NCT02867761|141460244|SUPERIORITY|||||||0.35|||||||Linear Mixed Effects Model|||P Value for percentage of days with any symptoms (shortness of breath, chest tightness, wheezing, cough, or sputum)||||0.35
70976392|NCT02867761|141460244|SUPERIORITY|||||||0.61|||||||Linear Mixed Effects Model|||P Value for percentage of days with shortness of breath||||0.61
70976393|NCT02867761|141460244|SUPERIORITY|||||||0.48|||||||Linear Mixed Effects Model|||P Value for percentage of days with chest tightness||||0.48
70976394|NCT02867761|141460244|SUPERIORITY|||||||0.81|||||||Linear Mixed Effects Model|||P Value for percentage of days with wheezing||||0.81
70976395|NCT02867761|141460244|SUPERIORITY|||||||0.17|||||||Linear Mixed Effects Model|||P Value for percentage of days with cough||||0.17
70976396|NCT02867761|141460244|SUPERIORITY|||||||0.64|||||||Linear Mixed Effects Model|||P Value for percentage of days with sputum||||0.64
70976397|NCT02867761|141460244|SUPERIORITY|||||||0.84|||||||Linear Mixed Effects Model|||P Value for percentage of days with use of albuterol.||||0.84
70976398|NCT04506294|141460252|SUPERIORITY|||||||0.536|||||||t-test, 2 sided|||||||.536
70976399|NCT05523973|141460274|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||0.66
70976400|NCT05523973|141460275|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
70976401|NCT05523973|141460276|SUPERIORITY|||||||0.09|||||||Sign test|||||||0.09
70976402|NCT05523973|141460277|SUPERIORITY|||||||0.722|||||||Sign test|||||||.722
70976403|NCT05523973|141460278|SUPERIORITY|||||||0.28|||||||Sign test|||||||.28
70976404|NCT05523973|141460279|SUPERIORITY|||||||0.15|||||||Sign test|||||||.15
70976405|NCT05523973|141460280|SUPERIORITY|||||||0.8|||||||Sign test|||||||.8
70976406|NCT05523973|141460281|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||||||.12
70976407|NCT05523973|141460282|SUPERIORITY|||||||0.92|||||||Sign test|||||||.92
70976408|NCT04187092|141460305|SUPERIORITY||||||<|0.05|||||||ANCOVA|||The 12-week changes in the KOOS scores, and the 12-week changes in the IKDC scores were analyzed by way of analysis of covariance (ANCOVA). Covariates: Age and sex of the subject, the subject's baseline outcome measure, the subject's baseline IKDC Total score, and the subject's standardized intake date (i.e., i.e., subject's intake date minus the intake date of the first enrolled subject) served as the ANCOVA concomitant adjustment variables||||<0.05
70976409|NCT03242954|141460330|SUPERIORITY||Cohen's f square|0.011|STANDARD_ERROR_OF_MEAN|0.208||0.5148|TWO_SIDED|95.0|0.001|0.101|||Regression, Linear|||||0.101|0.001|0.5148
70976410|NCT03242954|141460331|SUPERIORITY||Cohen's f square|0.306|STANDARD_ERROR_OF_MEAN|0.149|<|0.0001|TWO_SIDED|95.0|0.169|0.389|||Regression, Linear|||||0.389|0.169|<.0001
70976411|NCT03242954|141460332|SUPERIORITY||Cohen's f square|0.008|STANDARD_ERROR_OF_MEAN|0.213||0.4324|TWO_SIDED|95.0|0.001|0.073|||GEE Linear model|||||0.073|0.001|0.4324
70976412|NCT03242954|141460333|SUPERIORITY||Cohen's f square|0.26|STANDARD_ERROR_OF_MEAN|0.149|<|0.0001|TWO_SIDED|95.0|0.175|0.374|||GEE Linear model|||||0.374|0.175|<.0001
70976413|NCT00542620|141460384|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.25% or equivalently if the p-value for the one-sided test of H0: D\>0.25% against HA: D=\<0.25%, was less than or equal to 2.5%, where D is the mean treatment difference (mixing injections minus separate injections).|Median Difference (Final Values)|-0.691||||0.001||95.0|-1.049|-0.334||If non-inferiority was confirmed, the superiority of the mixed injection group over separate injection group was to be investigated|ANCOVA|Baseline HbA1c as covariate||||-0.334|-1.049|0.001
70976414|NCT00542620|141460385|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.25% or equivalently if the p-value for the one-sided test of H0: D\>0.25% against HA: D=\<0.25%, was less than or equal to 2.5%, where D is the mean treatment difference (mixing injections minus separate injections).|Mean Difference (Final Values)|-0.594||||0.003||95.0|-0.97|-0.219||If non-inferiority was confirmed, the superiority of the mixed injection group over separate injection group was to be investigated.|ANCOVA|Baseline HbA1c as covariate.||||-0.219|-0.970|0.003
70976415|NCT00542620|141460386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.35|STANDARD_ERROR_OF_MEAN|14.59||0.573||95.0|-38.77|22.08|||ANCOVA|With adjustment on baseline fructosamine and the change in insulin administration mode||||22.08|-38.77|0.573
70976416|NCT00542620|141460387|SUPERIORITY_OR_OTHER|||||||0.063|||||||ANCOVA|With adjustment on baseline value||||||0.063
70976417|NCT00542620|141460388|SUPERIORITY_OR_OTHER|||||||0.389|||||||ANCOVA|With adjustment on baseline value||||||0.389
70976418|NCT00542620|141460389|SUPERIORITY_OR_OTHER|||||||0.856|||||||ANCOVA|With adjustment on baseline value||||||0.856
70976419|NCT00542620|141460390|SUPERIORITY_OR_OTHER|||||||0.917|||||||ANCOVA|With adjustment on baseline value||||||0.917
70976420|NCT00542620|141460391|SUPERIORITY_OR_OTHER|||||||0.209|||||||ANCOVA|With adjustment on baseline value||||||0.209
70976421|NCT00542620|141460392|SUPERIORITY_OR_OTHER|||||||0.22|||||||ANCOVA|With adjustment on baseline value||||||0.220
70976422|NCT00542620|141460393|SUPERIORITY_OR_OTHER|||||||0.234|||||||ANCOVA|With adjustment for baseline value||||||0.234
70976423|NCT00542620|141460394|SUPERIORITY_OR_OTHER|||||||0.534|||||||ANCOVA|With adjustment on baseline value||||||0.534
70976424|NCT00542620|141460395|SUPERIORITY_OR_OTHER|||||||0.722|||||||ANCOVA|With adjustment on baseline value||||||0.722
70976425|NCT00542620|141460396|SUPERIORITY_OR_OTHER|||||||0.727|||||||ANCOVA|With adjustment on baseline value||||||0.727
70976426|NCT00542620|141460397|SUPERIORITY_OR_OTHER|||||||0.411|||||||ANCOVA|With adjustment on baseline value||||||0.411
70976427|NCT00542620|141460398|SUPERIORITY_OR_OTHER|||||||0.471|||||||ANCOVA|With adjustment on baseline value||||||0.471
70976428|NCT00542620|141460401|SUPERIORITY_OR_OTHER|||||||0.127|||||||ANCOVA|With adjustment on baseline value||||||0.127
70976429|NCT00542620|141460402|SUPERIORITY_OR_OTHER|||||||0.1|||||||ANCOVA|With adjustment on baseline value||||||0.1
70976430|NCT00542620|141460403|SUPERIORITY_OR_OTHER|||||||0.166|||||||ANCOVA|With adjustment on baseline value||||||0.166
70976431|NCT00542620|141460404|SUPERIORITY_OR_OTHER|||||||0.023|||||||ANCOVA|With adjustment on baseline value||||||0.023
70976432|NCT00542620|141460405|SUPERIORITY_OR_OTHER|||||||0.439|||||||ANCOVA|With adjustment on baseline value||||||0.439
70976433|NCT00542620|141460406|SUPERIORITY_OR_OTHER|||||||0.202|||||||ANCOVA|With adjustment on baseline value||||||0.202
70976434|NCT00542620|141460407|SUPERIORITY_OR_OTHER|||||||0.665|||||||ANCOVA|With adjustment on baseline value||||||0.665
70976435|NCT00956930|141460414|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.122||||0.007|TWO_SIDED|95.0|0.027|0.557|||Log Rank|||||0.557|0.027|0.007
70976436|NCT02908100|141460433|SUPERIORITY||Absolute Difference|6.4||||0.373|TWO_SIDED|95.0|-8.5|21.2|||Cochran-Mantel-Haenszel|||||21.2|-8.5|0.373
70976437|NCT02908100|141460433|SUPERIORITY||Absolute Difference|7.5||||0.339|TWO_SIDED|95.0|-7.3|22.4|||Cochran-Mantel-Haenszel|||||22.4|-7.3|0.339
70976438|NCT02908100|141460434|SUPERIORITY||Absolute Difference|8.7||||0.223|TWO_SIDED|95.0|-6.1|23.5|||Cochran-Mantel-Haenszel|||||23.5|-6.1|0.223
70976439|NCT02908100|141460434|SUPERIORITY||Absolute Difference|3.0||||0.737|TWO_SIDED|95.0|-11.8|17.7|||Cochran-Mantel-Haenszel|||||17.7|-11.8|0.737
70976440|NCT02908100|141460435|SUPERIORITY||Absolute Difference|4.1||||0.614|TWO_SIDED|95.0|-10.7|18.9|||Cochran-Mantel-Haenszel|||||18.9|-10.7|0.614
70976441|NCT02908100|141460435|SUPERIORITY||Absolute Difference|4.1||||0.607|TWO_SIDED|95.0|-10.7|18.9|||Cochran-Mantel-Haenszel|||||18.9|-10.7|0.607
70976442|NCT02908100|141460436|SUPERIORITY||Absolute Difference|6.4||||0.41|TWO_SIDED|95.0|-8.5|21.2|||Cochran-Mantel-Haenszel|||||21.2|-8.5|0.410
70976443|NCT02908100|141460436|SUPERIORITY||Absolute Difference|6.4||||0.418|TWO_SIDED|95.0|-8.5|21.2|||Cochran-Mantel-Haenszel|||||21.2|-8.5|0.418
70976444|NCT02908100|141460437|SUPERIORITY||Absolute Difference|14.9||||0.378|TWO_SIDED|95.0|-14.0|43.7|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q1||43.7|-14|0.378
70976445|NCT02908100|141460437|SUPERIORITY||Absolute Difference|7.5||||0.732|TWO_SIDED|95.0|-21.7|36.7|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q1||36.7|-21.7|0.732
70976446|NCT02908100|141460437|SUPERIORITY||Absolute Difference|-0.4||||0.5|TWO_SIDED|95.0|-29.2|28.4|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q2||28.4|-29.2|0.500
70976447|NCT02908100|141460437|SUPERIORITY||Absolute Difference|8.6||||0.234|TWO_SIDED|95.0|-21.4|38.7|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q2||38.7|-21.4|0.234
70976448|NCT02908100|141460437|SUPERIORITY||Absolute Difference|15.5||||0.364|TWO_SIDED|95.0|-14.9|46.0|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q3||46|-14.9|0.364
70976449|NCT02908100|141460437|SUPERIORITY||Absolute Difference|15.2||||0.134|TWO_SIDED|95.0|-14.1|44.4|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q3||44.4|-14.1|0.134
70976450|NCT02908100|141460437|SUPERIORITY||Absolute Difference|-7.1||||0.83|TWO_SIDED|95.0|-37.6|23.3|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q4||23.3|-37.6|0.830
70976451|NCT02908100|141460437|SUPERIORITY||Absolute Difference|-2.2||||0.963|TWO_SIDED|95.0|-32.1|27.8|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q4||27.8|-32.1|0.963
70976452|NCT02908100|141460438|SUPERIORITY||Absolute Difference|19.0||||0.189|TWO_SIDED|95.0|-9.4|47.5|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q1||47.5|-9.4|0.189
70976453|NCT02908100|141460438|SUPERIORITY||Absolute Difference|6.7||||0.909|TWO_SIDED|95.0|-21.9|35.2|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q1||35.2|-21.9|0.909
70976454|NCT02908100|141460438|SUPERIORITY||Absolute Difference|-0.4||||0.5|TWO_SIDED|95.0|-29.2|28.4|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q2||28.4|-29.2|0.500
70976455|NCT02908100|141460438|SUPERIORITY||Absolute Difference|3.3||||0.234|TWO_SIDED|95.0|-27.1|33.8|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q2||33.8|-27.1|0.234
70976456|NCT02908100|141460438|SUPERIORITY||Absolute Difference|15.5||||0.364|TWO_SIDED|95.0|-14.9|46.0|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q3||46|-14.9|0.364
70976457|NCT02908100|141460438|SUPERIORITY||Absolute Difference|7.2||||0.31|TWO_SIDED|95.0|-22.0|36.3|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q3||36.3|-22|0.310
70976458|NCT02908100|141460438|SUPERIORITY||Absolute Difference|-2.1||||0.922|TWO_SIDED|95.0|-32.5|28.2|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q4||28.2|-32.5|0.922
70976459|NCT02908100|141460438|SUPERIORITY||Absolute Difference|-5.9||||0.701|TWO_SIDED|95.0|-35.4|23.7|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q4||23.7|-35.4|0.701
70976460|NCT02908100|141460439|SUPERIORITY||Absolute Difference|3.1||||0.692|TWO_SIDED|95.0|-10.9|17.1|||Cochran-Mantel-Haenszel|||Week 24||17.1|-10.9|0.692
70976461|NCT02908100|141460439|SUPERIORITY||Absolute Difference|1.9||||0.871|TWO_SIDED|95.0|-12.0|15.9|||Cochran-Mantel-Haenszel|||Week 24||15.9|-12|0.871
70976462|NCT02908100|141460439|SUPERIORITY||Absolute Difference|11.2||||0.105|TWO_SIDED|95.0|-2.8|25.1|||Cochran-Mantel-Haenszel|||Week 48||25.1|-2.8|0.105
70976463|NCT02908100|141460439|SUPERIORITY||Absolute Difference|7.7||||0.286|TWO_SIDED|95.0|-6.1|21.6|||Cochran-Mantel-Haenszel|||Week 48||21.6|-6.1|0.286
70976464|NCT02908100|141460440|SUPERIORITY||Absolute Difference|-1.6||||0.936|TWO_SIDED|95.0|-16.8|13.6|||Cochran-Mantel-Haenszel|||Week 24||13.6|-16.8|0.936
70976465|NCT02908100|141460440|SUPERIORITY||Absolute Difference|-2.9||||0.683|TWO_SIDED|95.0|-18.2|12.4|||Cochran-Mantel-Haenszel|||Week 24||12.4|-18.2|0.683
70976466|NCT02908100|141460440|SUPERIORITY||Absolute Difference|11.7||||0.086|TWO_SIDED|95.0|-3.4|26.8|||Cochran-Mantel-Haenszel|||Week 48||26.8|-3.4|0.086
70976467|NCT02908100|141460440|SUPERIORITY||Absolute Difference|0.9||||0.879|TWO_SIDED|95.0|-14.2|16.1|||Cochran-Mantel-Haenszel|||Week 48||16.1|-14.2|0.879
70976468|NCT01262625|141460468|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|the pre-defined non-inferiority margin of 1.25|Hazard Ratio (HR)|1.03||||0.19|TWO_SIDED|95.0|0.61|1.75|||Regression, Cox|||||1.75|0.61|0.19
70976469|NCT01262625|141460469|SUPERIORITY|||||||0.08|||||||DeLong|(DeLong et al 1988)||||||0.08
70976470|NCT01262625|141460469|SUPERIORITY|||||||0.02|||||||DeLong|(DeLong et al 1988)||||||0.02
70976471|NCT01214044|141460474|OTHER|A paired t-test was done to see if the time of the dim light melatonin onset changed from baseline to post-treatment.||||||0.2||||||A priori threshold for significance was p = 0.05.|t-test, 2 sided|paired t-test||A within subjects comparison was done to compare the time of the dim light melatonin onset before treatment with escitalopram (Study Visit 3) and after treatment with escitalopram (Study Visit 11).||||0.2
70976472|NCT01214044|141460475|OTHER|A paired t-test was done to see if the Hamilton-21 score decreased from baseline to post-treatment.||||||0.01||||||A priori threshold for significance was p = 0.05.|t-test, 1 sided|paired t-test||"We hypothesized that there would be a decrease in the Hamilton-21 score with escitalopram treatment.~A within subjects comparison was done to compare the Hamilton-21 score before treatment with escitalopram (Study Visit 3) and after treatment with escitalopram (Study Visit 11)."||||0.01
70976473|NCT01214044|141460476|OTHER|A paired t-test was done to see if the Beck Depression Inventory-II score decreased from baseline to post-treatment.||||||0.14||||||A priori threshold for significance was p = 0.05.|t-test, 1 sided|paired t-test||"We hypothesized that there would be a decrease in the Beck Depression Inventory-II score with escitalopram treatment.~A within subjects comparison was done to compare the Beck Depression Inventory-II score before treatment with escitalopram (Study Visit 3) and after treatment with escitalopram (Study Visit 11)."||||0.14
70976474|NCT01214044|141460477|OTHER|Spearman's rank-order correlation (non-parametric test) was used.||||||0.06||||||Spearman's rho (rs) = 0.66|Spearman's rank-order correlation|||We hypothesized that there would be a correlation between the change in phase angle difference and the decrease in the Hamilton-21 score with escitalopram treatment. The phase angle difference is the interval, in hours, between the dim light melatonin onset (a marker of biological time) and the average midpoint of sleep during the prior week.||||0.06
70976475|NCT01214044|141460477|OTHER|Spearman's rank-order correlation (non-parametric test) was used.||||||0.48||||||Spearman's rho (rs) = 0.02|Spearman's rank-order correlation|||We hypothesized that there would be a correlation between the change in phase angle difference and the decrease in the Beck Depression Inventory-II score with escitalopram treatment. The phase angle difference is the interval, in hours, between the dim light melatonin onset (a marker of biological time) and the average midpoint of sleep during the prior week.||||0.48
70976476|NCT00464204|141460484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-331.0|STANDARD_DEVIATION|1033.0||0.0185|TWO_SIDED|95.0|-640.0|-21.0||One-sided t-test assuming unequal variances (as variances were significantly different between treatment groups).No multiple comparisons were made. A priori threshold for statistical significance for the confirmatory analysis on FAS: 0.025 one-sided.|t-test, 1 sided||Considered difference: Voluven® minus NaCl 0.9 %|"Null-hypothesis: The amount of study drug required to achieve initial hemodynamic stabilization in patients treated with Voluven® is higher than or equal to this amount in patients treated with NaCl.~Alternative hypothesis: The amount of study drug required to achieve initial hemodynamic stabilization is lower in patients treated with Voluven® than in patients treated with NaCl."||-21|-640|0.0185
70976477|NCT04698525|141460501|NON_INFERIORITY|"A new treatment (memantine) that is not much worse or non-inferior to the standard treatment (valproate) may be attractive if, compared to it, it is expected to cause fewer side effects or improve quality of life or if its dosing regimen is easier to tolerate."|Mean Difference (Final Values)|5.3|STANDARD_DEVIATION|14.0||0.9|TWO_SIDED|95.0|0.0|10.0||"Comparison between VPA and Memantine was:~0.9 p-value (two-tailed)"|Wilcoxon (Mann-Whitney)|"Memantine 3.534 z corrected for ties 0.0004 p-value (two-tailed)~VPA 3.418 z corrected for ties 0.0006 p-value (two-tailed)"||Null hypothesis: Memantine is as effective as valproate in treating episodic migraine.|We made also student t|10|0|0.9
70976478|NCT05384041|141460506|SUPERIORITY|||||||0.056|||||||Regression, Linear|||Intent to Treat analyses||||0.056
70976479|NCT05384041|141460507|SUPERIORITY|||||||0.048|||||||t-test, 2 sided|||Difference (Active - Control) at Week 1||||0.048
70976480|NCT05384041|141460508|SUPERIORITY|||||||0.2595|||||||t-test, 2 sided|||Difference (Active-Control) at Week 1||||0.2595
70976481|NCT05384041|141460508|SUPERIORITY|||||||0.1286|||||||t-test, 2 sided|||Difference (Active-Control) at Week 2||||0.1286
70976482|NCT05384041|141460508|SUPERIORITY|||||||0.1449|||||||t-test, 2 sided|||Difference (Active-Control) at Week 4||||0.1449
70976483|NCT05384041|141460509|SUPERIORITY|||||||0.2065|||||||t-test, 2 sided|||Difference (Active-Control) at Week 1||||0.2065
70976484|NCT05384041|141460509|SUPERIORITY|||||||0.1349|||||||t-test, 2 sided|||Difference (Active-Control) at Week 2||||0.1349
70976485|NCT05384041|141460509|SUPERIORITY|||||||0.1142|||||||t-test, 2 sided|||Difference (Active-Control) at Week 4||||0.1142
70976486|NCT05384041|141460510|SUPERIORITY|||||||0.231|||||||Chi-squared|||Difference (Active-Control) at Week 1||||0.231
70976487|NCT05384041|141460510|SUPERIORITY|||||||0.192|||||||Chi-squared|||Difference (Active-Control) at Week 2||||0.192
70976488|NCT05384041|141460510|SUPERIORITY|||||||0.045|||||||Chi-squared|||Difference (Active-Control) at Week 4||||0.045
70976489|NCT05384041|141460512|SUPERIORITY|||||||0.005|||||||Regression, Linear|||||||0.005
70976490|NCT05384041|141460513|SUPERIORITY|||||||0.0026|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.0026
70976491|NCT05384041|141460513|SUPERIORITY|||||||0.4706|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.4706
70976492|NCT05384041|141460513|SUPERIORITY|||||||0.0197|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.0197
70976493|NCT05384041|141460513|SUPERIORITY|||||||0.4858|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.4858
70976494|NCT05384041|141460513|SUPERIORITY|||||||0.0183|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.0183
70976495|NCT05384041|141460513|SUPERIORITY|||||||0.7885|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.7885
70976496|NCT05384041|141460514|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||<0.001
70976497|NCT05384041|141460514|SUPERIORITY|||||||0.45|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.450
70976498|NCT05384041|141460514|SUPERIORITY|||||||0.008|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.008
70976499|NCT05384041|141460514|SUPERIORITY|||||||0.438|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.438
70976500|NCT05384041|141460514|SUPERIORITY|||||||0.016|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.016
70976501|NCT05384041|141460514|SUPERIORITY|||||||0.355|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.355
70976502|NCT05384041|141460515|SUPERIORITY|||||||0.046|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.046
70976503|NCT05384041|141460515|SUPERIORITY|||||||0.351|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.351
70976504|NCT05384041|141460515|SUPERIORITY|||||||0.053|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.053
70976505|NCT05384041|141460515|SUPERIORITY|||||||0.12|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.120
70976506|NCT05384041|141460515|SUPERIORITY|||||||0.17|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.170
70976507|NCT05384041|141460515|SUPERIORITY|||||||0.122|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.122
70976508|NCT05384041|141460516|SUPERIORITY|||||||0.044|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.044
70976509|NCT05384041|141460516|SUPERIORITY|||||||0.751|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.751
70976510|NCT05384041|141460516|SUPERIORITY|||||||0.013|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.013
70976511|NCT05384041|141460516|SUPERIORITY|||||||0.318|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.318
70976512|NCT05384041|141460516|SUPERIORITY|||||||0.173|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.173
70976513|NCT05384041|141460516|SUPERIORITY|||||||0.142|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.142
70976514|NCT05384041|141460517|SUPERIORITY|||||||0.026|||||||Chi-squared|||Difference (Active-Control) at Week 1||||0.026
70976515|NCT05384041|141460517|SUPERIORITY|||||||0.241|||||||Chi-squared|||Difference (Active-Control) at Week 1||||0.241
70976516|NCT05384041|141460517|SUPERIORITY|||||||0.059|||||||Chi-squared|||Difference (Active-Control) at Week 2||||0.059
70976517|NCT05384041|141460517|SUPERIORITY|||||||0.478|||||||Chi-squared|||Difference (Active-Control) at Week 2||||0.478
70976518|NCT05384041|141460517|SUPERIORITY|||||||0.009|||||||Chi-squared|||Difference (Active-Control) at Week 4||||0.009
70976519|NCT05384041|141460517|SUPERIORITY|||||||0.729|||||||Chi-squared|||Difference (Active-Control) at Week 4||||0.729
70976520|NCT05384041|141460518|SUPERIORITY|||||||0.044|||||||Chi-squared|||Difference (Active-Control) at Week 1||||0.044
70976521|NCT05384041|141460518|SUPERIORITY|||||||0.067|||||||Chi-squared|||Difference (Active-Control) at Week 2||||0.067
70976522|NCT05384041|141460518|SUPERIORITY|||||||0.016|||||||Chi-squared|||Difference (Active-Control) at Week 4||||0.016
70976523|NCT05384041|141460518|SUPERIORITY|||||||0.006|||||||Chi-squared|||Difference (Active-Control) at Week 1||||0.006
70976524|NCT05384041|141460518|SUPERIORITY|||||||0.036|||||||Chi-squared|||Difference (Active-Control) at Week 2||||0.036
70976525|NCT05384041|141460518|SUPERIORITY|||||||0.016|||||||Chi-squared|||Difference (Active-Control) at Week 4||||0.016
70976526|NCT05384041|141460518|SUPERIORITY|||||||0.914|||||||Chi-squared|||Difference (Active-Control) at Week 1||||0.914
70976527|NCT05384041|141460518|SUPERIORITY|||||||0.887|||||||Chi-squared|||Difference (Active-Control) at Week 2||||0.887
70976528|NCT05384041|141460518|SUPERIORITY|||||||0.791|||||||Chi-squared|||Difference (Active-Control) at Week 4||||0.791
70976529|NCT02086331|141460519|OTHER||||||||||||||||||Intraclass correlation of repeated measures - 0.96, p=0.08|||
70976530|NCT00510276|141460526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.82||||0.005|TWO_SIDED|95.0|1.44|8.2||A gate-keeper strategy was applied to adjust for multiple tests.|Mixed Models Analysis|||Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||8.20|1.44|0.005
70976531|NCT00510276|141460527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9||||0.006|TWO_SIDED|95.0|1.68|10.12||A gate-keeper strategy was applied to adjust for multiple tests.|Mixed Models Analysis|||Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 relationship subscale score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||10.12|1.68|0.006
70976532|NCT00510276|141460528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.73||||0.018|TWO_SIDED|95.0|1.0|10.46||A gate-keeper strategy was applied to adjust for multiple tests.|Mixed Models Analysis|||Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 relationship subscale score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||10.46|1.00|0.018
70976533|NCT00510276|141460529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.36||||0.034|TWO_SIDED|95.0|0.33|8.39||A gate-keeper strategy was applied to adjust for multiple tests.|Mixed Models Analysis|||Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 psychological health subscale score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||8.39|0.33|0.034
70976534|NCT00510276|141460530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4||||0.074|TWO_SIDED|95.0|-0.33|7.12||A gate-keeper strategy was applied to adjust for multiple tests.|ANCOVA|||Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 life outlook subscale score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||7.12|-0.33|0.074
70976535|NCT00510276|141460531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43|||<|0.001|TWO_SIDED|95.0|-0.63|-0.24|||ANCOVA|ANCOVA with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in CGI-ADHD-S score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.24|-0.63|<0.001
70976536|NCT00510276|141460532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.04|||<|0.001|TWO_SIDED|95.0|-5.94|-2.15|||Mixed Models Analysis|||Tested was the null hypothesis that there is no statistically significant difference in CAARS-S:SV score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-2.15|-5.94|<0.001
70976537|NCT00510276|141460533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.02|TWO_SIDED|95.0|-0.45|-0.04|||ANCOVA|ANCOVA with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in PGI-I scores at 12-week endpoint between atomoxetine and placebo treatment groups.||-0.04|-0.45|0.020
71095739|NCT00762177|141699885|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70976538|NCT00510276|141460534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.282|TWO_SIDED|95.0|-1.19|0.35|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in MADRS score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.35|-1.19|0.282
71095740|NCT00762177|141699886|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70976539|NCT00510276|141460535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.556|TWO_SIDED|95.0|-2.21|1.19|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in BAI score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||1.19|-2.21|0.556
71095741|NCT00762177|141699887|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71095742|NCT00762177|141699888|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70976540|NCT00510276|141460536|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Pearson's Correlation Coefficient|||Tested was the null hypothesis that AAQOL-29 total score and CAARS-Inv:SV total score are not correlated.||||<0.001
70976541|NCT00510276|141460537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.198|TWO_SIDED|95.0|-0.39|0.08|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in TLFB incidence for use of alcohol score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.08|-0.39|0.198
70976542|NCT00510276|141460538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.825|TWO_SIDED|95.0|-0.33|0.26|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in TLFB incidence for use of caffeine score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.26|-0.33|0.825
70976543|NCT00510276|141460540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82||||0.233|TWO_SIDED|95.0|-0.53|2.17|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in TLFB incidence for use of nicotine score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||2.17|-0.53|0.233
70976544|NCT00510276|141460541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.676|TWO_SIDED|95.0|-0.24|0.37|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in TLFB incidence for use of marijuana score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.37|-0.24|0.676
71095743|NCT00762177|141699889|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70976545|NCT00510276|141460542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.382|TWO_SIDED|95.0|-1.0|0.39|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in Fagerstorm Test for Nicotine Dependence score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.39|-1.00|0.382
70976546|NCT00510276|141460543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.656|TWO_SIDED|95.0|-1.24|0.78|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in SASS score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.78|-1.24|0.656
70976547|NCT00510276|141460544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.61||||0.201|TWO_SIDED|95.0|-4.08|0.86|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in Driving Behavior Survey Self-Report score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.86|-4.08|0.201
71008500|NCT02355665|141524908|SUPERIORITY||Estimated Mean Difference|-0.03||||0.608|TWO_SIDED|95.0|-0.54|0.49||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of anxiety between treatments. The alternative hypothesis was a difference in distribution of the ratings of anxiety between treatments.||0.49|-0.54|0.608
71095744|NCT00762177|141699890|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71095745|NCT00762177|141699891|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71008501|NCT02355665|141524909|SUPERIORITY||Estimated Mean Difference|-0.63||||0.014|TWO_SIDED|95.0|-1.16|-0.09||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of anxiety between treatments. The alternative hypothesis was a difference in distribution of the ratings of anxiety between treatments.||-0.09|-1.16|0.014
71008502|NCT02355665|141524910|SUPERIORITY||Estimated Mean Difference|0.04||||0.9|TWO_SIDED|95.0|-0.3|0.38||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of anxiety between treatments. The alternative hypothesis was a difference in distribution of the ratings of anxiety between treatments.||0.38|-0.30|0.900
71095746|NCT00762177|141699892|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71095747|NCT00762177|141699893|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71034213|NCT00318461|141578300|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 1.2 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 1.2 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|0.01|||<|0.0001||95.0|-0.16|0.18|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||0.18|-0.16|<0.0001
70976548|NCT00510276|141460545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.06|||<|0.001|TWO_SIDED|95.0|-7.39|-2.72|||Mixed Models Analysis|Adjusted for treatment, investigator, visit, treatment-by-visit interaction, baseline score, baseline score-by-visit interaction.||Tested was the null hypothesis that there is no difference in CAARS-Inv:SV score changes from baseline to 12-week endpoint between the atomoxetine group and the placebo group. With approximately 220 patients per arm, assuming a 68% completion rate and an estimated effect size of atomoxetine over placebo of 0.35, using a 5% significance level, the analysis was expected to have 90% power to detect a difference between atomoxetine and placebo at week 12.||-2.72|-7.39|<0.001
70976549|NCT00510276|141460546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61||||0.933|TWO_SIDED|95.0|-16.41|17.63|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in Driving Behavior Survey Other-Report score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||17.63|-16.41|0.933
70976550|NCT00510276|141460547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.95||||0.007|TWO_SIDED|95.0|-5.09|-0.81|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Behavioral regulation score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.81|-5.09|0.007
70976551|NCT00510276|141460548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.219|TWO_SIDED|95.0|-1.5|0.35|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A emotional control section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.35|-1.50|0.219
70976552|NCT00510276|141460549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.58||||0.002|TWO_SIDED|95.0|-12.37|-2.78|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A GEC section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-2.78|-12.37|0.002
70976553|NCT00510276|141460550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.644|TWO_SIDED|95.0|-0.47|0.29|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Inconsistency section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.29|-0.47|0.644
70976554|NCT00510276|141460551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.097|TWO_SIDED|95.0|-0.02|0.25|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEFS-A infrequency score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.25|-0.02|0.097
70976555|NCT00510276|141460552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97||||0.002|TWO_SIDED|95.0|-1.57|-0.37|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Inhibit Section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.37|-1.57|0.002
70976556|NCT00510276|141460553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67||||0.044|TWO_SIDED|95.0|-1.33|-0.02|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Initiate section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.02|-1.33|0.044
70976557|NCT00510276|141460554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.49||||0.003|TWO_SIDED|95.0|-7.43|-1.55|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Metacognition section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-1.55|-7.43|0.003
70976558|NCT00510276|141460555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.456|TWO_SIDED|95.0|-0.51|0.23|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A negativity section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.23|-0.51|0.456
71095748|NCT05259033|141699925|SUPERIORITY|Responses were analysed using an analysis of covariance (ANCOVA) model with region and randomised treatment as fixed factors and baseline HbA1c as covariate. Each imputed dataset is analysed separately and estimates are combined using Rubin's rules.|Estimated treatment difference|-0.44|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.33|||ANCOVA|||Treatment policy strategy||-0.33|-0.56|<0.0001
71095749|NCT01405911|141699936|OTHER||Difference in Least Squares Means|-7.11|||<|0.001|TWO_SIDED|95.0|-9.85|-4.36|||Constrained Longitudinal Data Analysis|||||-4.36|-9.85|<0.001
70976559|NCT00510276|141460556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.051|TWO_SIDED|95.0|-1.31|0.0|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Organization of Materials section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.00|-1.31|0.051
71095750|NCT01405911|141699936|OTHER||Difference in Least Squares Means|-9.08|||<|0.001|TWO_SIDED|95.0|-11.82|-6.33|||Constrained Longitudinal Data Analysis|||||-6.33|-11.82|<0.001
70976560|NCT00510276|141460557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.002|TWO_SIDED|95.0|-2.19|-0.47|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Plan/Organize section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.47|-2.19|0.002
70976561|NCT00510276|141460558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.045|TWO_SIDED|95.0|-1.04|-0.01|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A SHIFT section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.01|-1.04|0.045
70976562|NCT00510276|141460559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.001|TWO_SIDED|95.0|-1.35|-0.32|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Self Monitor Section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.32|-1.35|0.001
70976563|NCT00510276|141460560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.008|TWO_SIDED|95.0|-1.23|-0.19|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Task Monitor section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.19|-1.23|0.008
70976564|NCT00510276|141460561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||<|0.001|TWO_SIDED|95.0|-1.98|-0.63|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Working Memory section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.63|-1.98|<0.001
70976565|NCT00510276|141460562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.065|TWO_SIDED|95.0|-1.42|0.04|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in ESS score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.04|-1.42|0.065
70976566|NCT00510276|141460563|SUPERIORITY_OR_OTHER|||||||0.788||95.0|||||Cochran-Mantel-Haenszel|Tested was smoking status across treatment.||Tested was the null hypothesis that smoking status is not a predictor of response to atomoxetine treatment compared with placebo||||0.788
70976567|NCT00510276|141460564|SUPERIORITY_OR_OTHER|||||||0.482||95.0||||Tested was smoking status across treatment.|Cochran-Mantel-Haenszel|||Tested was the null hypothesis that smoking status is not a predictor of strong response to atomoxetine treatment compared with placebo||||0.482
70976568|NCT03486392|141460568|SUPERIORITY||Difference of least square (LS) Means|-6.75|STANDARD_ERROR_OF_MEAN|1.056|<|0.001|TWO_SIDED|95.0|-9.31|-4.19|||Dunnett's method|||||-4.19|-9.31|< 0.001
70976569|NCT03486392|141460568|SUPERIORITY||Difference of LS Means|-8.07|STANDARD_ERROR_OF_MEAN|0.921|<|0.001|TWO_SIDED|95.0|-10.31|-5.84|||Dunnett's method|||||-5.84|-10.31|< 0.001
70976570|NCT03486392|141460568|SUPERIORITY||Difference of LS Means|-10.04|STANDARD_ERROR_OF_MEAN|0.934|<|0.001|TWO_SIDED|95.0|-12.31|-7.78|||Dunnett's method|||||-7.78|-12.31|< 0.001
70976571|NCT03486392|141460568|SUPERIORITY||Difference of LS Means|-5.78|STANDARD_ERROR_OF_MEAN|0.91|<|0.001|TWO_SIDED|95.0|-7.99|-3.57|||Dunnett's method|||||-3.57|-7.99|< 0.001
70976572|NCT01107444|141460612|SUPERIORITY_OR_OTHER_LEGACY|||||||0.284||||||The t-test was based on the logarithm of the ratio of tumor size at Cycle 2 to that at baseline as this measure follows a normal distribution.|t-test, 1 sided|||||||0.284
70976573|NCT01948830|141460635|NON_INFERIORITY_OR_EQUIVALENCE|The following hypothesis was tested at a one-sided 0.025 level. Non-inferiority with respect to BCVA: H01: μtreat and extend - μmonthly ≤ - Δ versus HA1: μtreat and extend - μmonthly \> - Δ where μtreat and extend and μmonthly are the unknown mean changes from baseline in BCVA to Month 12 in the treat and extend regimen and the monthly regimen, respectively. Δ is the non-inferiority margin and is pre-defined to be 5 letters for the justification of the margin.|||||<|0.001|||||||ANCOVA|||||||<0.001
70976574|NCT01260454|141460663|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||t-test, 2 sided|||This is open-label, uncontrolled data; the comparison is made between each individual's baseline.||||0.03
70976575|NCT02525549|141460709|NON_INFERIORITY|provides 85% power of success|Equivalence ratio|93.12|||||TWO_SIDED|90.0|88.6|102.0|||Fieller's method|||||102.00|88.6|
70976576|NCT02525549|141460710|NON_INFERIORITY|provides 85% power of success|Equivalence ratio|98.7|||||TWO_SIDED|90.0|92.3|109.4|||Fieller's method|||||109.4|92.3|
70976577|NCT03094195|141460717|SUPERIORITY||least squares mean|-0.2|STANDARD_ERROR_OF_MEAN|0.56||0.689|TWO_SIDED|95.0|-1.3|0.9|||ANCOVA|Multiplicity adjustment for the pairwise comparisons has been performed using the Hochberg procedure. Adjusted p-value 0.689||||0.9|-1.3|0.689
70976578|NCT03094195|141460717|SUPERIORITY||LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|0.54||0.35|TWO_SIDED|95.0|-1.6|0.6|||ANCOVA|Multiplicity adjustment for the pairwise comparisons has been performed using the Hochberg procedure. Adjusted p-value 0.689||||0.6|-1.6|0.350
70976579|NCT03094195|141460721|SUPERIORITY||Odds Ratio (OR)|0.9||||0.908|TWO_SIDED|95.0|0.3|3.2|||Regression, Logistic|||||3.2|0.3|0.908
70976580|NCT03094195|141460721|SUPERIORITY||Odds Ratio (OR)|1.4||||0.609|TWO_SIDED|95.0|0.4|4.5|||Regression, Logistic|||||4.5|0.4|0.609
70976581|NCT03094195|141460722|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8|TWO_SIDED|95.0|0.3|3.2|||Regression, Logistic|||||3.2|0.3|0.800
70976582|NCT03094195|141460722|SUPERIORITY||Odds Ratio (OR)|1.4||||0.653|TWO_SIDED|95.0|0.4|4.5|||Regression, Logistic|||||4.5|0.4|0.653
70976583|NCT03094195|141460724|SUPERIORITY||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.49||0.225|TWO_SIDED|95.0|-0.4|1.6|||ANCOVA|||||1.6|-0.4|0.225
70976584|NCT03094195|141460724|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.53||0.914|TWO_SIDED|95.0|-1.0|1.1|||ANCOVA|||||1.1|-1.0|0.914
70976585|NCT02238847|141460728|NON_INFERIORITY|The prespecified non-inferiority margin was set at 20%. This was chosen to support a practical study size while still able to identify major differences if this were the case.|||||<|0.01||||||Reported p-value of \<0.01 is calculated p-value. (p\<0.05 was considered significant)|Exact Non-inferiority|||||||<0.01
71034214|NCT00318461|141578300|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 0.6 mg+metformin was superior to placebo + metformin. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-0.78|||<|0.0001||95.0|-0.99|-0.57|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.57|-0.99|<0.0001
70976586|NCT02238847|141460729|SUPERIORITY|||||||0.66|||||||Fisher Exact|||||||0.66
70976587|NCT02440581|141460754|OTHER|T-tests||||||0.443|||||||t-test, 2 sided|||||||.443
70976588|NCT02440581|141460755|OTHER|T-tests||||||0.49|||||||t-test, 2 sided|||||||.490
70976589|NCT02440581|141460756|OTHER|T-tests|||||<|0.001|||||||t-test, 2 sided|||||||<.001
70976590|NCT02440581|141460757|OTHER|T-Tests||||||0.083|||||||t-test, 2 sided|||||||.083
70976591|NCT02440581|141460758|OTHER|T-tests||||||0.283|||||||t-test, 2 sided|||||||.283
71034215|NCT00318461|141578300|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 0.6 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 0.6 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|0.29||||0.1026||95.0|0.12|0.46|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||0.46|0.12|0.1026
70976592|NCT03430986|141460760|SUPERIORITY||Least Squares (LS) Mean Difference|2.037|STANDARD_ERROR_OF_MEAN|0.1578|<|0.0001|TWO_SIDED|95.0|1.726|2.349|||MMRM|MMRM included treatment, timepoint, treatment-by-timepoint interaction as fixed effect using an unstructured covariance matrix.||||2.349|1.726|<0.0001
70976593|NCT03430986|141460761|SUPERIORITY||Percentage difference|68.4|||<|0.0001|TWO_SIDED|95.0|50.0|82.4|||Fisher Exact|2-sided test comparing responder rate between treatment group and control group.||||82.4|50.0|<0.0001
70976594|NCT02022826|141460765|OTHER||percentage of agreement|76.0||||0.0052|TWO_SIDED|95.0|69.0|83.0|||McNemar|||||83|69|0.0052
71095751|NCT01405911|141699936|OTHER||Difference in Least Squares Means|-1.97||||0.143|TWO_SIDED|95.0|-4.61|0.67|||Constrained Longitudinal Data Analysis|||||0.67|-4.61|0.143
71095752|NCT01405911|141699937|OTHER||Difference in Least Squares Means|-17.7|||<|0.001|TWO_SIDED|95.0|-21.55|-13.86|||Constrained Longitudinal Data Analysis|||||-13.86|-21.55|<0.001
70976595|NCT02022826|141460766|OTHER||precentage of agreement|92.0||||1|TWO_SIDED|95.0|87.0|96.0|||McNemar|||||96|87|1.00
70976596|NCT01078805|141460767|SUPERIORITY_OR_OTHER|||||||0.0177||95.0||||Comparison is between 0 to 6 months fracture incidence rate versus 6 to 12 months fracture incidence rate.|One-sample binomial proportion test|||||||0.0177
70976597|NCT01078805|141460767|SUPERIORITY_OR_OTHER|||||||0.0019||95.0||||Comparison is between 0 to 6 months fracture incidence rate versus 12 to 18 months fracture incidence rate.|One-sample binomial proportion test|||||||0.0019
70976598|NCT01078805|141460767|SUPERIORITY_OR_OTHER|||||||0.0143||95.0||||Comparison is between 0 to 6 months fracture incidence rate versus 18 to 24 months fracture incidence rate.|One-sample binomial proportion test|||||||0.0143
70976599|NCT01078805|141460768|SUPERIORITY_OR_OTHER|||||||0.0689||95.0||||Comparison is between 0 to 6 months fracture incidence rate versus 6 to 12 months fracture incidence rate.|One-sample binomial proportion test|||||||0.0689
70976600|NCT01078805|141460768|SUPERIORITY_OR_OTHER|||||||0.0412||95.0||||Comparison is between 0 to 6 months fracture incidence rate versus 12 to 18 months fracture incidence rate.|One-sample binomial proportion test|||||||0.0412
70976601|NCT01078805|141460768|SUPERIORITY_OR_OTHER|||||||0.0631||95.0||||Comparison is between 0 to 6 months fracture incidence rate versus 18 to 24 months fracture incidence rate.|One-sample binomial proportion test|||||||0.0631
70976602|NCT01078805|141460769|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
70976603|NCT01078805|141460770|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
70976604|NCT03694392|141460813|OTHER||Hazard Ratio (HR)|0.85|||<|0.05|TWO_SIDED|95.0|0.76|0.94||Adjustment for multiplicity for the secondary outcomes was performed with the use of Holm's adjustment method.|Regression, Cox|Models were adjusted for age, age squared, sex, and race or ethnic group after weighting with stabilized facility-specific propensity scores.|Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 15.3% (5.9%, 23.8%)|||0.94|0.76|<0.05
70976605|NCT03694392|141460814|OTHER||Hazard Ratio (HR)|0.84|||<|0.05|TWO_SIDED|95.0|0.65|1.09||Adjustment for multiplicity for the secondary outcomes was performed with the use of Holm's adjustment method.|Regression, Cox|Models were adjusted for age, age squared, sex, and race or ethnic group after weighting with stabilized facility-specific propensity scores.|Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 15.9% (-9.2% to 35.2%)|||1.09|0.65|<0.05
70976606|NCT03694392|141460815|OTHER||Hazard Ratio (HR)|0.83|||<|0.05|TWO_SIDED|95.0|0.66|1.06||Adjustment for multiplicity for the secondary outcomes was performed with the use of Holm's adjustment method.|Regression, Cox|Models were adjusted for age, age squared, sex, and race or ethnic group after weighting with stabilized facility-specific propensity scores.|Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 16.7% (-5.6% to 34.4%)|||1.06|0.66|<0.05
70976607|NCT03694392|141460816|OTHER||Hazard Ratio (HR)|0.98|||<|0.05|TWO_SIDED|95.0|0.88|1.08||Adjustment for multiplicity for the secondary outcomes was performed with the use of Holm's adjustment method.|Regression, Cox|Models were adjusted for age, age squared, sex, and race or ethnic group after weighting with stabilized facility-specific propensity scores.|Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 2.4% (-8.1% to 11.9%)|||1.08|0.88|<0.05
71034216|NCT00318461|141578300|NON_INFERIORITY_OR_EQUIVALENCE|A test for superiority of glimepiride+metformin to metformin was performed to verify assay sensitivity. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-1.07|||<|0.0001||95.0|-1.28|-0.86|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.86|-1.28|<0.0001
71095753|NCT01405911|141699937|OTHER||Difference in Least Squares Means|-16.41|||<|0.001|TWO_SIDED|95.0|-20.32|-12.5|||Constrained Longitudinal Data Analysis|||||-12.50|-20.32|<0.001
71034217|NCT00318461|141578301|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.29||||0.0016||95.0|-2.16|-0.41|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-0.41|-2.16|0.0016
71034218|NCT00318461|141578301|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-3.75|||<|0.0001||95.0|-4.48|-3.01|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-3.01|-4.48|<0.0001
71034219|NCT00318461|141578301|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.07||||0.0117||95.0|-1.94|-0.19|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-0.19|-1.94|0.0117
71034220|NCT00318461|141578301|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-3.53|||<|0.0001||95.0|-4.27|-2.79|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.79|-4.27|<0.0001
71034221|NCT00318461|141578301|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.28||||0.8198||95.0|-1.15|0.6|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||0.60|-1.15|0.8198
71034222|NCT00318461|141578301|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-2.73|||<|0.0001||95.0|-3.47|-2.0|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.00|-3.47|<0.0001
71034223|NCT00318461|141578302|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.11||||0.0378||95.0|-2.18|-0.05|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-0.05|-2.18|0.0378
71095754|NCT01405911|141699937|OTHER||Difference in Least Squares Means|1.3||||0.469|TWO_SIDED|95.0|-2.22|4.82|||Constrained Longitudinal Data Analysis|||||4.82|-2.22|0.469
71095755|NCT05762744|141699952|OTHER|Unpaired two-tailed t-test to test null hypothesis||||||0.37||||||The t-test was conducted on the logarithms of the variable.|t-test, 2 sided|||Null hypothesis: the order of FSIGTs (saline or exenatide-stimulated) does not affect the response during an FSIGT||||0.37
71095756|NCT05762744|141699953|OTHER|Two-tailed unpaired t-test to test null hypothesis||||||0.66|||||||t-test, 2 sided|||Null hypothesis: The order of FSIGT (exenatide-stimulated or saline) does not affect the response to an FSIGT.||||0.66
71095757|NCT05762744|141699954|OTHER|Two-tailed unpaired t-test to test null hypothesis||||||0.55|||||||t-test, 2 sided|||Null hypothesis: the order of testing (exenatide-stimulated or saline FSIGT) does not affect data obtained in the FSIGTs.||||0.55
71095758|NCT05762744|141699955|OTHER|Unpaired, two-tailed t-test to test the null hypothesis||||||0.45|||||||t-test, 2 sided|||The order of FSIGTs (exenatide-stimulated or saline) does not affect the response during an FSIGT||||0.45
71095759|NCT05762744|141699956|OTHER|Two-tailed unpaired t-test to test null hypothesis||||||0.86||||||The t-test was conducted on the logarithms of the variable|t-test, 2 sided|||Null hypothesis: the order of FSIGT (exenatide or saline) does not affect the response during an FSIGT||||0.86
71095760|NCT05762744|141699957|OTHER|Two-tailed p-test for unpaired data||||||0.44||||||The t-test was conducted on the logarithms of the variable.|t-test, 2 sided|||Null hypothesis: The order of FSIGTs (exenatide-stimulated or saline) does not affect the response to an FSIGT||||0.44
70976608|NCT03694392|141460817|OTHER||Hazard Ratio (HR)|1.16|||<|0.05|TWO_SIDED|95.0|0.75|1.8|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -15.7% (-79.5% to 25.5%)|||1.80|0.75|<0.05
70976609|NCT03694392|141460818|OTHER||Hazard Ratio (HR)|1.001|||<|0.05|TWO_SIDED|95.0|0.95|1.06|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -0.1% (-6.0% to 5.4%)|||1.06|0.95|<0.05
70976610|NCT03694392|141460819|OTHER||Hazard Ratio (HR)|1.8|||<|0.05|TWO_SIDED|95.0|-2.2|5.5|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 1.8% (-2.2% to 5.5%)|||5.5|-2.2|<0.05
70976611|NCT03694392|141460820|OTHER||Hazard Ratio (HR)|9.4|||<|0.05|TWO_SIDED|95.0|-5.4|22.1|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 9.4% (-5.4% to 22.1%)|||22.1|-5.4|<0.05
70976612|NCT03694392|141460821|OTHER||Hazard Ratio (HR)|0.94|||<|0.05|TWO_SIDED|95.0|0.86|1.02|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 6.2% (-2.2% to 13.9%)|||1.02|0.86|<0.05
70976613|NCT03694392|141460822|OTHER||Hazard Ratio (HR)|1.07|||<|0.05|TWO_SIDED|95.0|0.75|1.52|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -6.9% (-51.6% to 24.6%)|||1.52|0.75|<0.05
70976614|NCT03694392|141460823|OTHER||Hazard Ratio (HR)|0.95|||<|0.05|TWO_SIDED|95.0|0.76|1.12|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 5.2% (-18.8% to 24.4%)|||1.12|0.76|<0.05
70976615|NCT03694392|141460824|OTHER||Hazard Ratio (HR)|0.89|||<|0.05|TWO_SIDED|95.0|0.85|0.93|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 10.8% (6.6% to 14.7%)|||0.93|0.85|<0.05
71095761|NCT05762744|141699958|OTHER|||||||0.41|||||||t-test, 2 sided|||"Null hypothesis: no differences between the two groups with respect to exenatide's effect on first-phase insulin secretion.~t-test conducted on logarithms of the values"||||0.41
71095762|NCT05762744|141699958|OTHER|||||||0.38|||||||t-test, 2 sided|||Null hypothesis: no difference between two groups with respect to exenatide's effect on first phase insulin secretion||||0.38
70976616|NCT03694392|141460825|OTHER||Hazard Ratio (HR)|1.001|||<|0.05|TWO_SIDED|95.0|0.94|1.06|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -0.1% (-6.2% to 5.6%)|||1.06|0.94|<0.05
71095763|NCT05762744|141699959|OTHER|||||||0.8|||||||t-test, 2 sided|||Null hypothesis: the two genotype groups do not differ with respect to the effect of exenatide on the rate of glucose disappearance||||0.80
70976617|NCT03694392|141460826|OTHER||Hazard Ratio (HR)|1.46|||<|0.05|TWO_SIDED|95.0|1.06|2.0|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -45.5% (-100.2% to -5.8%)|||2.00|1.06|<0.05
70976618|NCT03694392|141460827|OTHER||Hazard Ratio (HR)|0.9|||<|0.05|TWO_SIDED|95.0|0.82|0.99|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 10.2% (1.4% to 18.2%)|||0.99|0.82|<0.05
71095764|NCT05762744|141699959|OTHER|||||||0.98|||||||t-test, 2 sided|||Null hypothesis: the two genotype groups do not differ with respect to the effect of exenatide on the rate of glucose disappearance during an FSIGT||||0.98
71095765|NCT01560416|141699980|SUPERIORITY|||||||0.79|||||||Log Rank|||||||0.79
71095766|NCT01560416|141699982|SUPERIORITY|||||||0.68|||||||Fisher Exact|||||||0.68
71095767|NCT03738215|141699993|SUPERIORITY||Least Squares Mean Difference|-2.5||||0.005|TWO_SIDED|95.0|-4.17|-0.89||Adjusted P-Value (based on truncated Hochberg with parameter=0.9)|MMRM|MMRM = mixed-effects model for repeated measures||||-0.89|-4.17|0.0050
70976619|NCT03694392|141460828|OTHER||Hazard Ratio (HR)|1.16|||<|0.05|TWO_SIDED|95.0|0.95|1.43|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -16.2% (-43.0% to 5.5%)|||1.43|0.95|<0.05
70976620|NCT03694392|141460829|OTHER||Hazard Ratio (HR)|0.84|||<|0.05|TWO_SIDED|95.0|0.76|0.94|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 15.7% (6.0% to 24.5%)|||0.94|0.76|<0.05
70976621|NCT03694392|141460830|OTHER||Hazard Ratio (HR)|0.9|||<|0.05|TWO_SIDED|95.0|0.6|1.34|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 10.3% (-33.9% to 39.9%)|||1.34|0.60|<0.05
70976622|NCT05900115|141460836|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.77|TWO_SIDED||||||Regression, Linear|||||||0.77
70976623|NCT05900115|141460837|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.02|STANDARD_ERROR_OF_MEAN|0.06||0.78|TWO_SIDED||||||Regression, Linear|||||||0.78
70976624|NCT05900115|141460838|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.13|STANDARD_ERROR_OF_MEAN|0.12||0.28|TWO_SIDED||||||Regression, Linear|||||||0.28
70976625|NCT05900115|141460839|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.05|STANDARD_ERROR_OF_MEAN|0.13||0.68|TWO_SIDED||||||Regression, Linear|||||||0.68
71034224|NCT00318461|141578302|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-3.61|||<|0.0001||95.0|-4.51|-2.72|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.72|-4.51|<0.0001
70976626|NCT05900115|141460840|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.32|STANDARD_ERROR_OF_MEAN|0.13||0.01|TWO_SIDED||||||Regression, Linear|||||||0.01
70976627|NCT05900115|141460841|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|-0.19|STANDARD_ERROR_OF_MEAN|0.14||0.18|TWO_SIDED||||||Regression, Linear|||||||0.18
70976628|NCT05900115|141460842|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.03|STANDARD_ERROR_OF_MEAN|0.12||0.83|TWO_SIDED||||||Regression, Linear|||||||0.83
70976629|NCT05900115|141460843|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.13||0.56|TWO_SIDED||||||Regression, Linear|||||||0.56
70976630|NCT05900115|141460844|EQUIVALENCE|To examine intervention effects on primary dichotomous outcomes at posttest, we used logistic regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Odds Ratio (OR)|1.11|STANDARD_ERROR_OF_MEAN|0.54||0.85|TWO_SIDED|95.0|0.38|3.2|||Regression, Logistic|||||3.20|.38|0.85
70976631|NCT05900115|141460845|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.0|STANDARD_ERROR_OF_MEAN|0.05||1|TWO_SIDED||||||Regression, Linear|||||||1.00
70976632|NCT00880750|141460859|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A standard 90% confidence interval (CI) was constructed for the difference in least square means of the primary pharmacodynamic (PD) variable between the granules formulation and the reference chewable tablet formulation. A critical reference representing +/- 20% of the reference chewable tablet formulation least squares mean was constructed. PD equivalence was to be claimed if the 90% CI was completely contained within the critical reference range of (-3.47, 3.47).|Mean Difference (Final Values)|-1.35|||||TWO_SIDED|90.0|-2.18|-0.51|||Mixed Models Analysis|||||-0.51|-2.18|
70976633|NCT00880750|141460860|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A standard 90% confidence interval (CI) was constructed for the difference in least square means of the primary pharmacodynamic (PD) variable between the granules formulation and the reference chewable tablet formulation. A critical reference representing +/- 20% of the reference chewable tablet formulation least squares mean was constructed. PD equivalence was to be claimed if the 90% CI was completely contained within the critical reference range of (-3.40, 3.40).|Mean Difference (Final Values)|-1.98|||||TWO_SIDED|90.0|-3.17|-0.8|||Mixed Models Analysis|||||-0.80|-3.17|
71034225|NCT00318461|141578302|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.23||||0.0185||95.0|-2.3|-0.16|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-0.16|-2.30|0.0185
71034226|NCT00318461|141578302|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-3.73|||<|0.0001||95.0|-4.64|-2.83|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.83|-4.64|<0.0001
70976634|NCT00880750|141460861|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric LS means|1.34||||||90.0|1.26|1.42|||Mixed Models Analysis|After application of the log transformation AUC 0-48 was analysed using a mixed effect linear model.||The LS means and associated SEs for granules and tablets as well as the difference between granules and tablets were determined. From the LS mean and SE of the difference, a 90% CI was constructed for the difference of the logs of granules and tablets. An exponential transformation was applied to the lower and upper limits of the CI. This created a point estimate and 90% CI for the ratio of LS means for granules to tablets.||1.42|1.26|
70976635|NCT00880750|141460862|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric LS means|1.26||||||90.0|1.2|1.33|||Mixed Models Analysis|After application of the log transformation Cmax was analysed using a mixed effect linear model.||The LS means and associated SEs for granules and tablets as well as the difference between granules and tablets were determined. From the LS mean and SE of the difference, a 90% CI was constructed for the difference of the logs of granules and tablets. An exponential transformation was applied to the lower and upper limits of the CI. This created a point estimate and 90% CI for the ratio of LS means for granules to tablets.||1.33|1.20|
70976636|NCT00880750|141460863|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.01||||||90.0|0.0|0.5|||Wilcoxon (Hodges-Lehmann)|The median difference and 90% CI for the median difference was then calculated based on Hodges-Lehmann estimate for Wilcoxon's Signed Rank test||||0.50|0.00|
71034227|NCT00318461|141578302|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.27||||0.9069||95.0|-1.33|0.8|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||0.80|-1.33|0.9069
70976637|NCT00670007|141460868|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|-0.279|||=|0.752|TWO_SIDED|95.0|-1.089|0.53||A 1-sided P-value \< 0.025 and a positive estimate of the treatment difference Early Start minus Delayed Start (ie, the lower bound of the 95% confidence interval \[CI\] being \> zero) will indicate superiority of Early Start compared with Delayed Start.|Regression, Linear|||Analysis of the annual rate of change in lung density (for TLC + FRC combined) was a linear random regression model with country, inspiration state, time since Day 1 \[CE1226\_4001\], and treatment-by time interaction as fixed effects and subject and subject-by-time interaction as random coefficients at a 1-sided significance level of 0.025.||0.530|-1.089|= 0.752
70976638|NCT00670007|141460868|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|-0.371|||=|0.823|TWO_SIDED|95.0|-1.159|0.417||A 1-sided P-value \< 0.025 and a positive estimate of the treatment difference Early Start minus Delayed Start (ie, the lower bound of the 95% CI being \> zero) will indicate superiority of Early Start compared with Delayed Start.|Regression, Linear|||Analysis of the annual rate of change in lung density (for TLC) was a linear random regression model with country, time since Day 1 \[CE1226\_4001\], and treatment-by-time interaction as fixed effects and subject and subject-by-time interaction as random coefficients at a 1-sided significance level of 0.025.||0.417|-1.159|= 0.823
70976639|NCT00670007|141460868|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|-0.176|||=|0.648|TWO_SIDED|95.0|-1.09|0.738||A 1-sided P-value \< 0.025 and a positive estimate of the treatment difference Early Start minus Delayed Start (ie, the lower bound of the 95% CI being \> zero) will indicate superiority of Early Start compared with Delayed Start.|Regression, Linear|||Analysis of the annual rate of change in lung density (for FRC) was a linear random regression model with country, time since Day 1 \[CE1226\_4001\], and treatment-by-time interaction as fixed effects and subject and subject-by-time interaction as random coefficients at a 1-sided significance level of 0.025.||0.738|-1.09|= 0.648
70976640|NCT00670007|141460869|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|-0.53||||0.526|TWO_SIDED|95.0|-2.179|1.12||Two-sided P-value|ANCOVA|||Analysis of the change in lung density (for TLC + FRC combined) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect.||1.120|-2.179|0.526
70976641|NCT00670007|141460869|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|-0.486||||0.558|TWO_SIDED|95.0|-2.126|1.154||Two-sided P-value|ANCOVA|||Analysis of the change in lung density (for TLC) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects.||1.154|-2.126|0.558
70976642|NCT00670007|141460869|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|0.019||||0.984|TWO_SIDED|95.0|-1.858|1.895||Two-sided P-value|ANCOVA|||Analysis of the change in lung density (for FRC) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects.||1.895|-1.858|0.984
70976643|NCT00670007|141460870|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|0.294||||0.883|TWO_SIDED|95.0|-3.645|4.233||Two-sided P-value|ANCOVA|||Analysis of the percent change in lung density (for TLC + FRC combined) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect.||4.233|-3.645|0.883
70976644|NCT00670007|141460870|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|-0.151||||0.941|TWO_SIDED|95.0|-4.172|3.87||Two-sided P-value|ANCOVA|||Analysis of the percent change in lung density (for TLC) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects.||3.870|-4.172|0.941
71034228|NCT00318461|141578302|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-2.77|||<|0.0001||95.0|-3.67|-1.87|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-1.87|-3.67|<0.0001
70976645|NCT00670007|141460870|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|1.787||||0.404|TWO_SIDED|95.0|-2.44|6.014||Two-sided P-value|ANCOVA|||Analysis of the percent change in lung density (for FRC) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects.||6.014|-2.440|0.404
70976646|NCT00618722|141460880|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.043|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||0.0|-0.9|0.043
70976647|NCT00618722|141460880|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.05|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||0.0|-0.8|0.050
71034229|NCT00318461|141578303|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-2.09|||<|0.0001||95.0|-2.68|-1.5|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||-1.50|-2.68|<0.0001
71095768|NCT03738215|141699993|SUPERIORITY||Least Squares Mean Difference|-1.5||||0.0727|TWO_SIDED|95.0|-3.16|0.12||Adjusted P-Value (based on truncated Hochberg with parameter=0.9)|MMRM|MMRM = mixed-effects model for repeated measures||||0.12|-3.16|0.0727
70922180|NCT03398148|141334939|SUPERIORITY||Adjusted Risk Difference|23.2||||0.0041|TWO_SIDED|90.0|9.9|36.4||P-value ≤ 0.01|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||36.4|9.9|0.0041
70922181|NCT03398148|141334939|SUPERIORITY||Adjusted Risk Difference|13.1||||0.1117|TWO_SIDED|90.0|-0.4|26.6|||Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||26.6|-0.4|0.1117
70922182|NCT03398148|141334940|SUPERIORITY||Adjusted Risk Difference|8.3||||0.0192|TWO_SIDED|90.0|2.5|14.1||P-value ≤ 0.05|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||14.1|2.5|0.0192
70922183|NCT03398148|141334940|SUPERIORITY||Adjusted Risk Difference|4.8||||0.0706|TWO_SIDED|90.0|0.4|9.1||P-value ≤ 0.1|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||9.1|0.4|0.0706
70922184|NCT03398148|141334940|SUPERIORITY||Adjusted Risk Difference|8.7||||0.017|TWO_SIDED|90.0|2.7|14.6||P-value ≤ 0.05|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||14.6|2.7|0.0170
70922185|NCT03398148|141334941|SUPERIORITY|||||||0.7737|||||||Chi-squared|P value for comparisons between treatment groups and placebo group using chi-square test or Fisher's exact test.||||||0.7737
70922186|NCT03398148|141334941|SUPERIORITY|||||||0.7432|||||||Fisher Exact|P value for comparisons between treatment groups and placebo group using chi-square test or Fisher's exact test.||||||0.7432
70922187|NCT03398148|141334941|SUPERIORITY|||||||0.7172|||||||Fisher Exact|P value for comparisons between treatment groups and placebo group using chi-square test or Fisher's exact test.||||||0.7172
70922188|NCT03398148|141334942|SUPERIORITY||Adjusted Risk Difference|4.7||||0.0722|TWO_SIDED|90.0|0.4|9.0||P-value ≤ 0.1|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||9.0|0.4|0.0722
70922189|NCT03398148|141334942|SUPERIORITY||Adjusted Risk Difference|3.1||||0.148|TWO_SIDED|90.0|-0.4|6.6|||Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||6.6|-0.4|0.1480
70922190|NCT03398148|141334942|SUPERIORITY||Adjusted Risk Difference|1.7||||0.3042|TWO_SIDED|90.0|-1.0|4.5|||Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||4.5|-1.0|0.3042
70922191|NCT03398148|141334943|SUPERIORITY||Least Squares (LS) Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|2.13||0.003|TWO_SIDED|90.0|-9.94|-2.89||P-value ≤ 0.01|Mixed-effect model repeated measurement|||||-2.89|-9.94|0.0030
70922192|NCT03398148|141334943|SUPERIORITY||Least Squares (LS) Mean Difference|-8.2|STANDARD_ERROR_OF_MEAN|2.11||0.0001|TWO_SIDED|90.0|-11.67|-4.71||P-value ≤ 0.001|Mixed-effect model repeated measurement|||||-4.71|-11.67|0.0001
70922193|NCT03398148|141334943|SUPERIORITY||Least Squares (LS) Mean Difference|-7.7|STANDARD_ERROR_OF_MEAN|2.14||0.0004|TWO_SIDED|90.0|-11.27|-4.19||P-value ≤ 0.001|Mixed-effect model repeated measurement|||||-4.19|-11.27|0.0004
70922194|NCT03398148|141334944|SUPERIORITY||Least Squares (LS) Mean Difference|17.3|STANDARD_ERROR_OF_MEAN|6.47||0.0081|TWO_SIDED|90.0|6.61|28.0||P-value ≤ 0.01|Mixed-effect model repeated measurement|||||28|6.61|0.0081
70922195|NCT03398148|141334944|SUPERIORITY||Least Squares (LS) Mean Difference|20.3|STANDARD_ERROR_OF_MEAN|6.37||0.0017|TWO_SIDED|90.0|9.74|30.79||P-value ≤ 0.01|Mixed-effect model repeated measurement|||||30.79|9.74|0.0017
70922196|NCT03398148|141334944|SUPERIORITY||Least Squares (LS) Mean Difference|19.9|STANDARD_ERROR_OF_MEAN|6.49||0.0024|TWO_SIDED|90.0|9.22|30.67||P-value ≤ 0.01|Mixed-effect model repeated measurement|||||30.67|9.22|0.0024
70922197|NCT03398148|141334945|SUPERIORITY||Least Squares (LS) Mean Difference|1.208||||0.3315|TWO_SIDED|90.0|-0.8429|3.2596|||Mixed-effect model repeated measurement|||||3.2596|-0.8429|0.3315
70922198|NCT03398148|141334945|SUPERIORITY||LS Mean of Difference|2.447||||0.0451|TWO_SIDED|90.0|0.4415|4.4519||P-value ≤ 0.05|Mixed-effect model repeated measurement|||||4.4519|0.4415|0.0451
70922199|NCT03398148|141334945|SUPERIORITY||LS Mean of Difference|2.392||||0.0543|TWO_SIDED|90.0|0.3498|4.4352||P-value ≤ 0.1|Mixed-effect model repeated measurement|||||4.4352|0.3498|0.0543
70922200|NCT03398148|141334946|SUPERIORITY||LS Mean of Difference|3.662||||0.0367|TWO_SIDED|90.0|0.7841|6.5402||P-value \<= 0.1|Mixed-effect model repeated measurement||P-value for test of difference between each Risankizumab dose group and placebo for mean change from baseline using the mixed-effect repeated measure model The unstructured covariance structure was used to estimate within subject errors.|||6.5402|0.7841|0.0367
70976648|NCT00618722|141460880|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.249|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||0.2|-0.7|0.249
70976649|NCT00618722|141460881|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9||||0.003|TWO_SIDED|95.0|0.7|3.1|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||3.1|0.7|0.003
70976650|NCT00618722|141460881|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4||||0.03|TWO_SIDED|95.0|0.1|2.6|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||2.6|0.1|0.030
70976651|NCT00618722|141460881|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6||||0.012|TWO_SIDED|95.0|0.4|2.8|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||2.8|0.4|0.012
70976652|NCT00618722|141460882|SUPERIORITY_OR_OTHER||Difference from Placebo|38.9||||0.015|TWO_SIDED|95.0|12.6|65.2|||Fisher Exact|||||65.2|12.6|0.015
70976653|NCT00618722|141460882|SUPERIORITY_OR_OTHER||Difference from Placebo|28.9||||0.096|TWO_SIDED|95.0|0.4|57.5|||Fisher Exact|||||57.5|0.4|0.096
70976654|NCT00618722|141460882|SUPERIORITY_OR_OTHER||Difference from Placebo|44.7||||0.003|TWO_SIDED|95.0|20.6|68.8|||Fisher Exact|||||68.8|20.6|0.003
70976655|NCT00618722|141460883|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.078|TWO_SIDED|95.0|0.0|0.6|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.6|0.0|0.078
70976656|NCT00618722|141460883|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.781|TWO_SIDED|95.0|-0.3|0.4|||Repeated easures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.4|-0.3|0.781
70976657|NCT00618722|141460883|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.146|TWO_SIDED|95.0|-0.1|0.5|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.5|-0.1|0.146
70976658|NCT00618722|141460883|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.076|TWO_SIDED|95.0|0.0|0.6|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.6|0.0|0.076
70976659|NCT00618722|141460883|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.975|TWO_SIDED|95.0|-0.3|0.3|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.3|-0.3|0.975
70976660|NCT00618722|141460883|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.183|TWO_SIDED|95.0|-0.1|0.5|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.5|-0.1|0.183
70976661|NCT00618722|141460883|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.017|TWO_SIDED|95.0|0.1|0.7|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.7|0.1|0.017
70976662|NCT00618722|141460883|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.022|TWO_SIDED|95.0|0.1|0.7|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.7|0.1|0.022
70976663|NCT00618722|141460883|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.081|TWO_SIDED|95.0|0.0|0.6|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.6|0.0|0.081
70976664|NCT00618722|141460883|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.51|TWO_SIDED|95.0|-0.2|0.4|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.4|-0.2|0.510
70976665|NCT00618722|141460883|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.33|TWO_SIDED|95.0|-0.5|0.2|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.2|-0.5|0.330
70976666|NCT00618722|141460883|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.72|TWO_SIDED|95.0|-0.3|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.4|-0.3|0.720
70976667|NCT00618722|141460883|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.205|TWO_SIDED|95.0|-0.1|0.5|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||0.5|-0.1|0.205
70976668|NCT00618722|141460883|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.41|TWO_SIDED|95.0|-0.5|0.2|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||0.2|-0.5|0.410
70976669|NCT00618722|141460883|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.436|TWO_SIDED|95.0|-0.2|0.4|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||0.4|-0.2|0.436
70976670|NCT00618722|141460884|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6||||0.762|TWO_SIDED|95.0|-9.1|12.3|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||12.3|-9.1|0.762
70976671|NCT00618722|141460884|SUPERIORITY_OR_OTHER||LS mean Difference|5.2||||0.248|TWO_SIDED|95.0|-3.8|14.2|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||14.2|-3.8|0.248
70976672|NCT00618722|141460884|SUPERIORITY_OR_OTHER||LS Mean Difference|9.3||||0.061|TWO_SIDED|95.0|-0.4|19.1|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||19.1|-0.4|0.061
70922201|NCT03398148|141334946|SUPERIORITY||LS Mean of Difference|4.19||||0.0151|TWO_SIDED|90.0|1.3656|7.0144||P-value \<= 0.05|Mixed-effect model repeated measurement||P-value for test of difference between each Risankizumab dose group and placebo for mean change from baseline using the mixed-effect repeated measure model The unstructured covariance structure was used to estimate within subject errors.|||7.0144|1.3656|0.0151
70922202|NCT03398148|141334946|SUPERIORITY||LS Mean of Difference|2.348||||0.1795|TWO_SIDED|90.0|-0.5322|5.2281|||Mixed-effect model repeated measurement||P-value for test of difference between each Risankizumab dose group and placebo for mean change from baseline using the mixed-effect repeated measure model The unstructured covariance structure was used to estimate within subject errors.|||5.2281|-0.5322|0.1795
70922203|NCT03398148|141334947|SUPERIORITY||Least Squares (LS) Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|1.91||0.0422|TWO_SIDED|90.0|0.75|7.06||P-value ≤ 0.05|Mixed-effect model repeated measurement|||||7.06|0.75|0.0422
70922204|NCT03398148|141334947|SUPERIORITY||Least Squares (LS) Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|1.87||0.0049|TWO_SIDED|90.0|2.23|8.42||P-value ≤ 0.01|Mixed-effect model repeated measurement|||||8.42|2.23|0.0049
70922205|NCT03398148|141334947|SUPERIORITY||Least Squares (LS) Mean Difference|4.6|STANDARD_ERROR_OF_MEAN|1.91||0.0156|TWO_SIDED|90.0|1.5|7.8||P-value ≤ 0.05|Mixed-effect model repeated measurement|||||7.80|1.50|0.0156
70922206|NCT03398148|141334948|SUPERIORITY|||||||1||||||P-Value for comparisons between treatment groups and placebo group using Fisher's exact test.|Fisher Exact|||Note: ITT1A includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 1.||||1
70922207|NCT03398148|141334949|SUPERIORITY||Adjusted Risk Difference|28.6|||<|0.0001|TWO_SIDED|95.0|22.3|34.8||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference.|||34.8|22.3|<0.0001
70922208|NCT03398148|141334950|SUPERIORITY||Adjusted Risk Difference|24.3|||<|0.0001|TWO_SIDED|95.0|19.3|29.4||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||29.4|19.3|<0.0001
70922209|NCT03398148|141334951|SUPERIORITY||Adjusted Risk Difference|16.6|||<|0.0001|TWO_SIDED|95.0|12.3|21.0||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||21.0|12.3|<0.0001
70922210|NCT03398148|141334952|SUPERIORITY||Adjusted Risk Difference|7.2|||<|0.0001|TWO_SIDED|95.0|4.2|10.2||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||10.2|4.2|<0.0001
70922211|NCT03398148|141334953|SUPERIORITY||Adjusted Risk Difference|21.8|||<|0.0001|TWO_SIDED|95.0|15.6|28.1||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||28.1|15.6|<0.0001
70922212|NCT03398148|141334954|SUPERIORITY||Adjusted Risk Difference|16.3|||<|0.0001|TWO_SIDED|95.0|10.3|22.4||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||22.4|10.3|<0.0001
70922213|NCT03398148|141334955|SUPERIORITY||Adjusted Risk Difference|9.3||||0.0021|TWO_SIDED|95.0|3.4|15.3||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||15.3|3.4|0.0021
70922214|NCT03398148|141334956|SUPERIORITY||Adjusted Risk Difference|5.6|||<|0.0001|TWO_SIDED|95.0|3.5|7.7||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||7.7|3.5|<0.0001
70922215|NCT03398148|141334957|SUPERIORITY||Least Squares (LS) Mean Difference|4.5|||<|0.0001|TWO_SIDED|95.0|3.13|5.97||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|ANCOVA||Between-group diff. and 95% CI calculated using ANCOVA/MMRM with RTB-MI for continuous endpoints.|||5.97|3.13|<0.0001
70922216|NCT03398148|141334958|SUPERIORITY||Least Squares (LS) Mean Difference|18.3|||<|0.0001|TWO_SIDED|95.0|13.38|23.25||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|ANCOVA||Between-group diff. and 95% CI calculated using ANCOVA/MMRM with RTB-MI for continuous endpoints.|||23.25|13.38|<0.0001
70922217|NCT03398148|141334959|SUPERIORITY||Risk Difference (RD)|-4.8|||<|0.0001|TWO_SIDED|95.0|-7.3|-2.2||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Chi-squared||95% CI for treatment differences is based on normal approximation of the binomial proportions.|||-2.2|-7.3|<0.0001
70922218|NCT03398148|141334960|SUPERIORITY||Adjusted Risk Difference|24.2|||<|0.0001|TWO_SIDED|95.0|17.9|30.5||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||30.5|17.9|<0.0001
71095769|NCT03738215|141699994|SUPERIORITY||Lease Squares Mean Difference|-0.3||||0.0727|TWO_SIDED|95.0|-0.49|-0.07||Adjusted P-Value (based on Hochberg procedure)|MMRM|MMRM = mixed-effects model for repeated measures||||-0.07|-0.49|0.0727
71095770|NCT03738215|141699994|SUPERIORITY||Least Squares Mean Difference|-0.2||||0.0944|TWO_SIDED|95.0|-0.39|0.03||Adjusted P-Value (based on Hochberg procedure)|MMRM|MMRM = mixed-effects model for repeated measures.||||0.03|-0.39|0.0944
70976673|NCT00624221|141460886|NON_INFERIORITY_OR_EQUIVALENCE|The sample size of 40 subjects was estimated based on having 80% power to determine greater than 10% difference in cell loss between groups with estimated standard deviation of 17 and estimated correlation of 0.5.||||||0.1|TWO_SIDED|95.0|||||paired difference t-test|||||||0.10
70976674|NCT00200057|141460916|SUPERIORITY_OR_OTHER||Proportion|0.73|||<|0.0001|TWO_SIDED|95.0|0.64|0.81||No multiplicity adjustments were made for the primary outcome analysis. Two-tailed p-values were considered statistically significant if they were less than 0.05.|Exact Binomial|||The exact Binomial test (two-sided) for one-sample proportions was used to test the null hypothesis that the success rate is equal to 0.5.||0.81|0.64|<0.0001
70976675|NCT00200057|141460917|SUPERIORITY_OR_OTHER||Proportion|0.73|||<|0.0001|TWO_SIDED|95.0|0.64|0.81||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Exact Binomial|||The exact Binomial test (two-sided) for one-sample proportions was used to test the null hypothesis that the success rate is equal to 0.5.||0.81|0.64|<0.0001
70976676|NCT00200057|141460918|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Wilcoxon signed-rank test|||||||<0.0001
70976677|NCT00200057|141460919|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Wilcoxon signed-rank test|||||||<0.0001
70976678|NCT00200057|141460920|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Wilcoxon signed-rank test|||||||<0.0001
70976679|NCT00200057|141460921|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Wilcoxon signed-rank test|||||||<0.0001
70976680|NCT00200057|141460922|SUPERIORITY_OR_OTHER||Proportion|0.71|||<|0.0001|TWO_SIDED|95.0|0.62|0.79||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Exact Binomial|||The exact Binomial test (two-sided) for one-sample proportions was used to test the null hypothesis that the success rate is equal to 0.5.||0.79|0.62|<0.0001
70976681|NCT00778830|141460923|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3176|||||TWO_SIDED|95.0|0.8078|2.1491||||||||2.1491|0.8078|
70976682|NCT02863068|141460934|SUPERIORITY|||||||0.2967||||||A matched pairs design was employed to test for changes in methemoglobin at baseline and EOS for all participants between treatment arms using a Wilcoxon signed rank test|Wilcoxon (Mann-Whitney)|||Change in methemoglobin from baseline to end of study (EOS) for all participants.||||0.2967
70976683|NCT02863068|141460935|SUPERIORITY|||||||0.2818||||||A matched pairs design was employed to test for changes in total ulcerated surface area at baseline and EOS between treatment arms using a Wilcoxon signed rank test|Wilcoxon (Mann-Whitney)|||Change in total ulcerated surface area from baseline to end of study (EOS)||||0.2818
70976684|NCT02863068|141460935|SUPERIORITY|||||||1|||||||Fisher Exact|Fisher's exact test was used to test for differences in frequencies between treatment arms||Difference in frequency of 25% total ulcerated surface area reduction between treatment arms||||1.0
70976685|NCT02863068|141460936|SUPERIORITY|||||||0.3754||||||A matched pairs design was employed to test for changes in average pain at baseline and EOS between treatment arms using a Wilcoxon signed rank test|Wilcoxon (Mann-Whitney)|||Change in average pain from baseline to end of study (EOS)||||0.3754
70976686|NCT02863068|141460938|SUPERIORITY|||||||0.1165||||||A matched pairs design was employed to test for changes in methemoglobin at baseline and EOS between treatment arms for participants on Hydroxyurea (HU) using a Wilcoxon signed rank test.|Wilcoxon (Mann-Whitney)|||Change in methemoglobin from baseline to end of study (EOS) for participants on Hydroxyurea (HU).||||0.1165
70976687|NCT02863068|141460938|SUPERIORITY|||||||0.4583||||||A matched pairs design was employed to test for changes in methemoglobin at baseline and EOS between treatment arms for participants off Hydroxyurea (HU) using a Wilcoxon signed rank test.|Wilcoxon (Mann-Whitney)|||Change in methemoglobin from baseline to end of study (EOS) for participants off Hydroxyurea (HU).||||0.4583
70976688|NCT02863068|141460939|SUPERIORITY|||||||0.068||||||A matched pairs design was employed to test for changes in total ulcerated surface area at baseline and EOS between treatment arms for participants on Hydroxyurea (HU) using a Wilcoxon signed rank test.|Wilcoxon (Mann-Whitney)|||Change in total ulcerated surface area from baseline to end of study (EOS) for participants on Hydroxyurea (HU).||||0.068
71095771|NCT03277274|141700004|OTHER|TAK-954 (Total): An analysis of variance (ANOVA) were performed on log transformed Cmax (total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.579|||||||ANOVA|||||||0.579
70976689|NCT02863068|141460939|SUPERIORITY|||||||0.5||||||A matched pairs design was employed to test for changes in total ulcerated surface area at baseline and EOS between treatment arms for participants off Hydroxyurea (HU) using a Wilcoxon signed rank test.|Wilcoxon (Mann-Whitney)|||Change in total ulcerated surface area from baseline to end of study (EOS) for participants off Hydroxyurea (HU).||||0.5
70976690|NCT02863068|141460939|SUPERIORITY|||||||1|||||||Fisher Exact|Difference in frequency of 25% total ulcerated surface area reduction between treatment arms for participants on Hydroxyurea (HU).||Difference in frequency of 25% total ulcerated surface area reduction between treatment arms for participants on Hydroxyurea (HU).||||1.0
70976691|NCT02863068|141460939|SUPERIORITY|||||||1|||||||Fisher Exact|Fisher's exact test was used to test for differences in frequencies between treatment arms for participants off Hydroxyurea (HU).||Difference in frequency of 25% total ulcerated surface area reduction between treatment arms for participants off Hydroxyurea (HU).||||1.0
71095772|NCT03277274|141700004|OTHER|TAK-954 (Total): An ANOVA were performed on log transformed Cmax (total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.026|||||||ANOVA|||||||0.026
70976692|NCT02863068|141460940|SUPERIORITY|||||||0.4298||||||A matched pairs design was employed to test for changes in average pain at baseline and EOS between treatment arms for participants on Hydroxyurea (HU) using a Wilcoxon signed rank test.|Wilcoxon (Mann-Whitney)|||Change in average pain from baseline to end of study (EOS) for participants on Hydroxyurea (HU).||||0.4298
70976693|NCT02863068|141460940|SUPERIORITY|||||||0.2701||||||A matched pairs design was employed to test for changes in average pain at baseline and EOS between treatment arms for participants off Hydroxyurea (HU) using a Wilcoxon signed rank test.|Wilcoxon (Mann-Whitney)|||Change in average pain from baseline to end of study (EOS) for participants off Hydroxyurea (HU).||||0.2701
70976694|NCT01734655|141460966|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||correlation analysis|||||||<.01
70976695|NCT01734655|141460967|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||correlation analysis|||||||<.01
70976696|NCT01734655|141460968|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||correlation analysis|||||||<.01
70976697|NCT01097629|141460999|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|26.3|||<|1e-05|TWO_SIDED|95.0|18.3|34.3||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 sTSTm, had planned marginal power of 97.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||34.3|18.3|<0.00001
70976698|NCT01097629|141461000|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|25.1|||<|1e-05||95.0|16.0|34.2||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 sTSTm, had planned marginal power of 95.7%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||34.2|16.0|<0.00001
70976699|NCT01097629|141461001|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-29.4|||<|1e-05|TWO_SIDED|95.0|-36.6|-22.3||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 WASO, had planned marginal power of 99.2%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-22.3|-36.6|<0.00001
70976700|NCT01097629|141461002|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-29.4|||<|1e-05|TWO_SIDED|95.0|-36.7|-22.1||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 WASO, had planned marginal power of 98.3%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-22.1|-36.7|<0.00001
70976701|NCT01097629|141461003|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-12.8||||3e-05|TWO_SIDED|95.0|-18.8|-6.9||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 sTSOm, had planned marginal power of 99.9%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-6.9|-18.8|0.00003
71095773|NCT03277274|141700004|OTHER|TAK-954 (Free): An ANOVA were performed on log transformed Cmax (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.02|||||||ANOVA|||||||0.020
71095774|NCT03277274|141700004|OTHER|TAK-954 (Free): An ANOVA were performed on log transformed Cmax (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.031|||||||ANOVA|||||||0.031
71095775|NCT03277274|141700005|OTHER|TAK-954 (Total): An ANOVA were performed on log transformed AUClast (Total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.151|||||||ANOVA|||||||0.151
71095776|NCT03277274|141700005|OTHER|TAK-954 (Total): An ANOVA were performed on log transformed AUClast (Total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.017|||||||ANOVA|||||||0.017
71095777|NCT03277274|141700005|OTHER|TAK-954 (Free): An ANOVA were performed on log transformed AUClast (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.129|||||||ANOVA|||||||0.129
71095778|NCT03277274|141700005|OTHER|TAK-954 (Free): An ANOVA were performed on log transformed AUClast (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.023|||||||ANOVA|||||||0.023
71095779|NCT03277274|141700006|OTHER|TAK-954 (Total): An ANOVA were performed on log transformed AUCinf (Total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.138|||||||ANOVA|||||||0.138
71095780|NCT03277274|141700006|OTHER|TAK-954 (Total): An ANOVA were performed on log transformed AUCinf (Total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.029|||||||ANOVA|||||||0.029
71095781|NCT03277274|141700006|OTHER|TAK-954 (Free): An ANOVA were performed on log transformed AUCinf (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.201|||||||ANOVA|||||||0.201
70922219|NCT03398148|141334961|SUPERIORITY||Adjusted Risk Difference|18.6|||<|0.0001|TWO_SIDED|95.0|12.4|24.8||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference.|||24.8|12.4|<0.0001
70922220|NCT03398148|141334962|SUPERIORITY||Least Squares (LS) Mean Difference|-1.627|||<|0.0001|TWO_SIDED|95.0|-2.3846|-0.8689||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Mixed-Effect Model Repeated Measures||Between-group diff. and 95% CI calculated using ANCOVA/MMRM with RTB-MI for continuous endpoints.|||-0.8689|-2.3846|<0.0001
70922221|NCT03398148|141334963|SUPERIORITY||Least Squares (LS) Mean Difference|-0.981|||<|0.0001|TWO_SIDED|95.0|-1.3285|-0.6326||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Mixed-Effect Model Repeated Measures||Between-group diff. and 95% CI calculated using ANCOVA/MMRM with RTB-MI for continuous endpoints.|||-0.6326|-1.3285|<0.0001
70922222|NCT02791230|141334964|SUPERIORITY||Hazard Ratio (HR)|0.6202||||0.0001|TWO_SIDED|95.0|0.4865|0.7906|||Cox proportional hazards model||Hazard ratio from a Cox proportional hazards model with treatment, Transthyretin (TTR) genotype (variant and wild-type) and New York Heart Association (NYHA) baseline classification (NYHA Classes I and II combined and NYHA Class III) in the model.|||0.7906|0.4865|0.0001
70922223|NCT02791230|141334967|SUPERIORITY||Hazard ratio|0.6133||||0.0005|TWO_SIDED|95.0|0.4666|0.8062|||Cox Proportional Hazards model||Hazard ratio from a Cox proportional hazards model with treatment, TTR genotype (variant and wild-type) and NYHA baseline classification (NYHA Classes I and II combined and NYHA Class III) in the model.|||0.8062|0.4666|0.0005
70922224|NCT04201834|141334996|SUPERIORITY|||||||0.27|||||||Paired T-Test|||||||0.27
70922225|NCT04201834|141334997|SUPERIORITY|||||||0.92|||||||Paired T-Test|||||||0.92
70922226|NCT04201834|141334998|SUPERIORITY|||||||0.36|||||||Paired T-Test|||||||0.36
70922227|NCT04201834|141334999|SUPERIORITY|||||||0.62|||||||Paired T-Test|||||||0.62
70922228|NCT04201834|141335002|SUPERIORITY|||||||0.11|||||||Paired T-Test|||||||0.11
70976702|NCT01097629|141461004|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-13.2||||3e-05|TWO_SIDED|95.0|-19.4|-7.0||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 sTSOm, had planned marginal power of 99.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-7.0|-19.4|0.00003
71095782|NCT03277274|141700006|OTHER|TAK-954 (Free): An ANOVA were performed on log transformed AUCinf (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.023|||||||ANOVA|||||||0.023
70922229|NCT04201834|141335003|SUPERIORITY|||||||0.02|||||||Paired T-Test|||||||0.02
70922230|NCT04201834|141335005|SUPERIORITY|||||||0.86|||||||Paired T-Test|||||||0.86
70922231|NCT04201834|141335006|SUPERIORITY|||||||0.27|||||||Paired T-Test|||||||0.27
70922232|NCT04201834|141335007|SUPERIORITY|||||||0.61|||||||Paired T-Test|||||||0.61
70922233|NCT04201834|141335008|SUPERIORITY|||||||0.37|||||||Paired T-Test|||||||0.37
70922234|NCT04201834|141335009|SUPERIORITY|||||||0.3|||||||Paired T-Test|||||||0.30
70922235|NCT04201834|141335010|SUPERIORITY|||||||0.82|||||||Paired t-test|||||||0.82
70922236|NCT03661359|141335012|OTHER|||||||0.727||||||correlation is significant at the 0.05 level (2 tailed)|pearson correlation|||Correlation between patient satisfaction and domains at risk.||||.727
70922237|NCT03661359|141335014|OTHER|||||||0.002||||||correlation is significant at the 0.01 level 2 tailed|pearson correlation|||correlation between physical quality of life and mental of life||||0.002
70922238|NCT03661359|141335016|OTHER|||||||0.727|TWO_SIDED|0.05|||||pearson correlation|||||||0.727
70922239|NCT04310735|141335017|OTHER|Independent-samples t-tests were conducted to compare the mean contrast of parameter estimate (COPE) values, derived from the contrast of smoking-related versus neutral cue activation, between the Expect-Yes and Expect-No groups in the ventromedial prefrontal cortex region of interest.||||||0.13||||||Statistical significance was defined a priori as p\<0.05.|t-test, 2 sided|||The null hypothesis was that there is no difference in the population means of the two groups.||||0.13
70922240|NCT04310735|141335017|OTHER|Independent-samples t-tests were conducted to compare the mean contrast of parameter estimate (COPE) values, derived from the contrast of smoking-related versus neutral cue activation, between the Expect-Yes and Expect-No groups in the dorsal anterior cingulate cortex region of interest.||||||0.25||||||Statistical significance was defined a priori as p\<0.05.|t-test, 2 sided|||The null hypothesis was that there is no difference in the population means of the two groups.||||.25
70976703|NCT01097629|141461005|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-12.1||||4e-05|TWO_SIDED|95.0|-17.8|-6.4||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 LPS, had planned marginal power of 81.4%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-6.4|-17.8|0.00004
70976704|NCT01097629|141461006|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-3.6||||0.2651|TWO_SIDED|95.0|-10.1|2.8||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 LPS, had planned marginal power of 76.2%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||2.8|-10.1|0.26510
71095783|NCT00835978|141700039|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.578||||0.0189|TWO_SIDED|95.0|1.017|2.448||A priori defined threshold for statistical significance was: alpha=0.10 (one-sided)|Cochran-Mantel-Haenszel|||ORR for the 2 treatment arms was compared with the Cochran-Mantel-Haenszel test stratified by ECOG performance status. The relative risk ratio estimator was used to contrast the treatment effects on the endpoint. Both a point estimate and a 2-sided 95% CI were calculated using a normal approximation.||2.448|1.017|0.0189
71095784|NCT00835978|141700040|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.849||||0.2444|TWO_SIDED|95.0|0.535|1.348|||Log Rank|||||1.348|0.535|0.2444
70976705|NCT01097629|141461007|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|26.4|||<|1e-05|TWO_SIDED|95.0|19.8|33.1|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Week 1 sTSTm, had planned marginal power of 98.3%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||33.1|19.8|<0.00001
70976706|NCT01097629|141461008|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-42.0|||<|1e-05|TWO_SIDED|95.0|-48.6|-35.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Night 1 WASO, had planned marginal power of 100.0%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||-35.3|-48.6|<0.00001
70976707|NCT01097629|141461009|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-13.1|||<|1e-05|TWO_SIDED|95.0|-17.7|-8.4|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Week 1 sTSOm, had planned marginal power of 99.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||-8.4|-17.7|<0.00001
71008503|NCT02355665|141524911|SUPERIORITY||Estimated Mean Difference|-0.06||||0.731|TWO_SIDED|95.0|-0.44|0.31||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of anxiety between treatments. The alternative hypothesis was a difference in distribution of the ratings of anxiety between treatments.||0.31|-0.44|0.731
71095785|NCT00327171|141700068|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.123||||0.5043|TWO_SIDED|95.0|0.8|1.58|||Log Rank||Estimated using Cox proportional Hazard model using treatment as the factor|||1.58|0.80|0.5043
71095786|NCT00327171|141700071|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.093||||0.5592|TWO_SIDED|95.0|0.81|1.48|||Log Rank||Estimated using Cox proportional Hazard model using treatment as the factor (4mg/kg vs. 2mg/kg)|||1.48|0.81|0.5592
71095787|NCT00327171|141700072|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.124||||0.5457|TWO_SIDED|95.0|0.77|1.64|||Log Rank||Estimated using Cox proportional Hazard model using treatment as the factor (4 mg/kg vs. 2mg/kg)|||1.64|0.77|0.5457
71095788|NCT00758043|141700122|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Estimated by evaluating the treatment differences in the SVR24planned rates (T12PR24/eRVR+ minus T12PR48/eRVR+) and the 95% CI for these groups (the entire 2 sided CI is to the right of the predefined non-inferiority margin of -10.5%).|Difference in proportions|4.5|||||TWO_SIDED|95.0|-2.1|11.1||||||Primary efficacy analysis was based on CI estimates (using the normal approximation, confidence limits were constructed for the difference in proportions) to rule out the inferiority of the T12/PR24/eRVR+ treatment regimen relative to the T12/PR48/eRVR+ treatment regimen. SVR24 was defined as undetectable HCV RNA at end of treatment through 24 weeks after the last planned dose.||11.1|-2.1|
70976708|NCT01097629|141461010|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-21.7|||<|1e-05|TWO_SIDED|95.0|-28.6|-14.9|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Night 1 LPS, had planned marginal power of 100.0%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||-14.9|-28.6|<0.00001
70976709|NCT05197803|141461013|SUPERIORITY||Mean Difference (Final Values)|3.32||||0.0001|ONE_SIDED||||||t-test, 1 sided|||The study compared the results between the unaided condition vs. aided condition (BTE)||||0.0001
70976710|NCT05197803|141461013|SUPERIORITY||Mean Difference (Final Values)|3.57||||0.0001|ONE_SIDED||||||t-test, 1 sided|||The study compared the results between the unaided condition vs. aided condition (RIC)||||0.0001
70976711|NCT00132041|141461014|OTHER||Success rate|0.18|||||TWO_SIDED|95.0|0.091|0.317|||||logistic regression model without correcting for the clustering effect|logistic regression was used to estimate the success rate||0.317|0.091|
70976712|NCT00132041|141461014|OTHER||Success rate|0.19|||||TWO_SIDED|95.0|0.136|0.252||||||logistic regression model after specifying site as cluster (using GEE approach).||0.252|0.136|
70976713|NCT00132041|141461015|OTHER||Success rate|0.18|||||TWO_SIDED|95.0|0.091|0.317|||||logistic regression model without correcting for the clustering effect|logistic regression was used to estimate the success rate||0.317|0.091|
70976714|NCT00132041|141461015|OTHER||Slope|-3.7913||||0.0004|TWO_SIDED|95.0|-5.9056|-1.6769|||Generlaized estimating equations|Multivariate logistic model. P-value for number of RFA sessions dichotomized 1: more than 1; using the latter as the reference.|This estimate is for the effect of a single RFA sessions (v multiple sessions) in the multivariate model response:18 mo success/failure; covariates: tumor size,repeated RFA, local tumor recurrence, remote tumor occurrence, and age and gender.|multivariate logistic regression model was fit using GEEs to correct for site clustering effects, in which, the response variable was success/failure at 18 months and the covariates were tumor size, whether or not a patient received repeated RFA, whether or not a local tumor recurrence occurred, whether or not a remote tumor occurrence occurred, and two common confounding factors - age and gender||-1.6769|-5.9056|0.0004
70976715|NCT00132041|141461016|OTHER||GEE|-0.9101||||0.0221|TWO_SIDED|95.0|-1.6894|-0.1308|||Generlaized Estimating Equations|multivariate GEE model using logistic link|Estimation parameter is for tumor size when controlling for other covariates.|Effect of tumor size in the multivariate model with response:18 mo success/failure; covariates: tumor size,repeated RFA, local tumor recurrence, remote tumor occurrence, and age and gender.||-0.1308|-1.6894|0.0221
70976716|NCT00132041|141461018|OTHER||Mean Difference (Final Values)|-0.458|STANDARD_ERROR_OF_MEAN|0.2496||0.06|TWO_SIDED|||||assuming unequal variance (Satterthwaite p)|t-test, 2 sided||Difference represents the size of tumors that do no recur minus those that do.|the mean tumor size in the two groups, recurred and non recurred tumors, will be compared using a t-test assuming H0: recur=non-recurr||||0.06
71095789|NCT00758043|141700122|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Estimated by evaluating the treatment differences in the SVR24planned rates (T12PR24/eRVR+ minus T12PR48/eRVR+) and the 95% CI for these groups (the entire 2 sided CI is to the right of the predefined non-inferiority margin of -10.5%).|Difference in proportions|2.0|||||TWO_SIDED|95.0|-4.3|8.2||||||SVR24 was defined as below the limit of quantitation at 24 weeks after the planned end of treatment. For subjects who had missing data at week 24 after the planned end of treatment, the week 12 data or the last follow-up time point after week 12 was carried forward for determining SVR24.||8.2|-4.3|
70976717|NCT00132041|141461020|OTHER||Sensitivity|0.083|||||TWO_SIDED|95.0|0.0|0.38|||||Twelve tumors were detected in the liver specimens, but only one of those was identified by the CT central readers|||0.38|0.00|
70976718|NCT00132041|141461020|OTHER||Specificity|0.75|||||TWO_SIDED|95.0|0.194|0.994|||||The central CT readers correctly identified three out of the four patients without pathologic evidence of tumor|Specificity||0.994|0.194|
70976719|NCT00132041|141461022|OTHER|McNemar's Test to compare success rates after assuming transplants as successes versus after assuming transplants as failures.||||||0.0001|||||||McNemar|||||||0.0001
70976720|NCT02613208|141461060|OTHER|Correlation analysis|Spearman coefficient|0.392|||<|0.001|||||||Spearman's correlation analysis|||Correlation between CTC and CEA level considering baseline CTC count||||<0.001
70976721|NCT02613208|141461060|OTHER|Correlation analysis|Spearman coefficient|0.088||||0.444|||||||Spearman's correlation analysis|||Correlation between CTC and CEA level considering CTC count at cycle 2||||0.444
70976722|NCT02613208|141461062|OTHER|Correlation analysis|Spearman coefficient|0.373|||<|0.001|||||||Spearman's correlation analysis|||Correlation between CTC and CA 15.3 level considering baseline CTC count||||<0.001
71034230|NCT00318461|141578303|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.38||||0.1845||95.0|-0.87|0.11|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||0.11|-0.87|0.1845
70976723|NCT02613208|141461062|OTHER|Correlation analysis|Spearman coefficient|0.129||||0.241|||||||Spearman's correlation analysis|||Correlation between CTC and CA 15.3 level considering CTC count at cycle 2||||0.241
71095790|NCT00758043|141700123|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Estimated by evaluating the treatment differences in the SVR at Week 72 planned rates (T12PR24/eRVR+ minus T12PR48/eRVR+) and the 95% CI for these groups (the entire 2 sided CI is to the right of the predefined non-inferiority margin of 10.5%).|Difference in Proportion|-0.5|||||TWO_SIDED|95.0|-7.7|6.8||||||||6.8|-7.7|
71095791|NCT00758043|141700123|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Estimated by evaluating the treatment differences in the SVR at Week 72 planned rates (T12PR24/eRVR+ minus T12PR48/eRVR+) and the 95% CI for these groups (the entire 2 sided CI is to the right of the predefined non-inferiority margin of 10.5%).|Odds Ratio, log|0.94|||||TWO_SIDED|95.0|0.49|1.82||||||||1.82|0.49|
70976724|NCT02939131|141461135|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not. The study was designed for at least 80% power to detect an effect size of 0.8 standard deviations (SD), which corresponded to a difference of four points. We assumed an intracluster correlation coefficient (ICC) between 0.02 and 0.16 and allowed for 10% non-evaluability. In a pre-planned interim analysis, we estimated the ICC based on the entry QIDS-SR to be 0.10.|Mean Difference (Final Values)|-3.86||||0.01|TWO_SIDED|95.0|-6.79|-0.94|||t-test, 2 sided||We subtracted the mean of the ESC group from the mean of the COMB-R group. Because a lower score indicated less severe depressive symptoms, a negative value indicated superiority.|||-0.94|-6.79|0.01
70976725|NCT02939131|141461136|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.|Mean Difference (Final Values)|44.3|||<|0.001|TWO_SIDED|95.0|23.1|65.5|||t-test, 2 sided||We subtracted the group mean of the site percents with response for the ESC group from that of the COMB-R group. A positive value indicates the COMB-R group had a higher mean percent of participants with response compared to the ESC group.|||65.5|23.1|<0.001
70976726|NCT02939131|141461137|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.|Mean Difference (Final Values)|30.9||||0.01|TWO_SIDED|95.0|8.9|52.9|||t-test, 2 sided||We subtracted the group mean of the site percents with remission for the ESC group from the COMB-R group so a positive value indicates the COMB-R group has more participants with remission.|||52.9|8.9|0.01
70976727|NCT02939131|141461138|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.|Mean Difference (Final Values)|19.0||||0.86|TWO_SIDED|95.0|-223.0|262.0|||t-test, 2 sided||Group mean for ESC is subtracted from the group mean for COMB-R. The group means are the means of the site mean CD4 cell counts.|||262|-223|0.86
70976728|NCT02939131|141461139|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.|Mean Difference (Final Values)|0.17||||0.66|TWO_SIDED|95.0|-0.65|0.99|||t-test, 2 sided||We subtracted the group mean for the ESC group from the group mean of the COMB-R group. The group means are the means of the site mean log10 HIV RNA copies/mL.|||0.99|-0.65|0.66
70976729|NCT02939131|141461140|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.04|TWO_SIDED|95.0|0.1|4.0|||t-test, 2 sided||A positive difference indicates COMB-R group had a site-level average of more days in last 30 with missed HIV medication doses.|Comparison of COMB-R and ESC groups, number of days in last 30 with any missed HIV medication doses reported at week 24.||4.0|0.1|0.04
71095792|NCT00845182|141700159|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|||||||<0.05
70976730|NCT02939131|141461140|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.96|TWO_SIDED|95.0|-5.0|5.2|||t-test, 2 sided||A positive difference reflects greater number of days with missed HIV medication doses in last 30 days for COMB-R group.|Comparison of COMB-R and ESC groups, number of days in last 30 with any missed HIV medication doses reported at week 48.||5.2|-5.0|0.96
70976731|NCT02939131|141461141|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.27|TWO_SIDED|95.0|-1.1|0.4|||t-test, 2 sided||A positive difference means the COMB-R group rated adherence to HIV medications better than the ESC group.|Comparison of COMB-R and ESC groups, how good was participant at taking HIV medication doses; reported at week 24.||0.4|-1.1|0.27
70976732|NCT02939131|141461141|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.44|TWO_SIDED|95.0|-0.4|0.9|||t-test, 2 sided||A positive difference would indicate the COMB-R group rated their adherence better than the ESC group.|Comparison of COMB-R and ESC groups, how good was participant at taking HIV medication doses; reported at week 48.||0.9|-0.4|0.44
70976733|NCT02939131|141461142|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.14|TWO_SIDED|95.0|-1.1|0.2|||t-test, 2 sided||A positive difference would indicate the COMB-R group rated their adherence better than the ESC group.|Comparison of COMB-R and ESC groups, how often did participant take HIV medication as instructed; reported at week 24.||0.2|-1.1|0.14
70976734|NCT02939131|141461142|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.49|TWO_SIDED|95.0|-0.6|1.1|||t-test, 2 sided||A positive difference would indicate the COMB-R group rated their adherence better than the ESC group.|Comparison of COMB-R and ESC groups, how often did participant take HIV medication as instructed; reported at week 48.||1.1|-0.6|0.49
71095793|NCT00845182|141700159|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
70976735|NCT02939131|141461143|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.05|TWO_SIDED|95.0|0.0|4.4|||t-test, 2 sided||A positive difference would indicate those in the COMB-R group had more days with missed depression medications than those in the ESC group.|Comparison of COMB-R and ESC groups, number of days in last 30 with any missed depression medication doses reported at week 24.||4.4|0.0|0.05
71095794|NCT01286324|141700177|SUPERIORITY|||||||0.21||||||Adjusted p-value based on a general linear model adjusted for group and the baseline of the measure|t-test, 2 sided|||||||0.21
71095795|NCT01286324|141700178|SUPERIORITY|||||||0.6||||||Adjusted p-value based on a general linear model adjusted for group and the baseline of the measure|t-test, 2 sided|||||||0.60
71095796|NCT01286324|141700179|SUPERIORITY|||||||0.47||||||Adjusted p-value based on a general linear model adjusted for group and the baseline of the measure|t-test, 2 sided|||Statistical Analysis for State Subscale||||0.47
70976736|NCT02939131|141461143|SUPERIORITY||Mean Difference (Final Values)|-2.7||||0.53|TWO_SIDED|95.0|-12.5|7.1|||t-test, 2 sided||A positive difference would indicate those in the COMB-R group reported more days with missed doses than those in the ESC group.|Comparison of COMB-R and ESC groups, number of days in last 30 with any missed depression medication doses reported at week 48.||7.1|-12.5|0.53
70976737|NCT02939131|141461144|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.13|TWO_SIDED|95.0|-1.5|0.2|||t-test, 2 sided||A positive difference would indicate those in the COMB-R group were better at taking medications.|Comparison of COMB-R and ESC groups, how good was participant at taking depression medication; reported at week 24.||0.2|-1.5|0.13
70976738|NCT02939131|141461144|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.53|TWO_SIDED|95.0|-1.1|2.0|||t-test, 2 sided||A positive difference would indicate those in the COMB-R group were better at taking their medications.|Comparison of COMB-R and ESC groups, how good was participant at taking depression medication; reported at week 48.||2.0|-1.1|0.53
70976739|NCT02939131|141461145|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.07|TWO_SIDED|95.0|-1.3|0.1|||t-test, 2 sided||A positive difference would indicate those in the COMB-R group reported better adherence.|Comparison of COMB-R and ESC groups, how often did participant take depression medication as instructed; reported at week 24.||0.1|-1.3|0.07
70976740|NCT02939131|141461145|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.28|TWO_SIDED|95.0|-0.8|2.3|||t-test, 2 sided||A positive difference would indicate those in the COMB-R group reported better adherence than those in the ESC group.|Comparison of COMB-R and ESC groups, how often did participant take depression medication as instructed; reported at week 48.||2.3|-0.8|0.28
70976741|NCT02939131|141461146|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.44|TWO_SIDED|95.0|-0.6|0.3|||t-test, 2 sided|||||0.3|-0.6|0.44
70976742|NCT02939131|141461148|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.67|TWO_SIDED|95.0|-0.4|0.3|||t-test, 2 sided|||The average number of scheduled study visits through week 24 was computed for each site. The analysis was of these site-level averages. These values were compared between study groups||0.3|-0.4|0.67
70976743|NCT02939131|141461148|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.74|TWO_SIDED|95.0|-0.7|0.5|||t-test, 2 sided|||We computed the average number of scheduled study visits through week 48 for each site. We then averaged the site-level values and compared study groups.||0.5|-0.7|0.74
70976744|NCT02939131|141461149|SUPERIORITY||Mean Difference (Final Values)|-1.99||||0.14|TWO_SIDED|95.0|-4.74|0.76|||t-test, 2 sided||We subtracted the mean of the ESC group from the mean of the COMB-R group. Because a lower score indicated less severe depressive symptoms, a negative value indicated superiority.|We tested the null hypothesis that the treatment group means were equal vs. not.||0.76|-4.74|0.14
70976745|NCT02939131|141461150|SUPERIORITY||Mean Difference (Final Values)|25.3||||0.05|TWO_SIDED|95.0|0.5|50.0|||t-test, 2 sided||We subtracted the group mean of the site percents with response for the ESC group from that of the COMB-R group. A positive value indicates the COMB-R group had a higher mean percent of participants with response compared to the ESC group.|We tested the null hypothesis that the treatment group means were equal vs. not.||50.0|0.5|0.05
70976746|NCT02939131|141461151|SUPERIORITY||Mean Difference (Final Values)|16.3||||0.24|TWO_SIDED|95.0|-12.3|44.8|||t-test, 2 sided||We subtracted the group mean of the site percents with remission for the ESC group from the COMB-R group so a positive value indicates the COMB-R group has more participants with remission.|We tested the null hypothesis that the treatment group means were equal vs. not.||44.8|-12.3|0.24
70976747|NCT02939131|141461152|SUPERIORITY||Mean Difference (Final Values)|6.79||||0.01|TWO_SIDED|95.0|2.3|11.28||This is the test of effect modification by sex at birth|t-test, 2 sided||A positive value indicates that the treatment difference (lower QIDS-SR score with COMB-R than with ESC) was greater for females compared to males.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||11.28|2.30|0.01
70976748|NCT02939131|141461152|SUPERIORITY||Mean Difference (Final Values)|-2.56||||0.23|TWO_SIDED|95.0|-7.05|1.93||This is the test of effect modification by age group|t-test, 2 sided||A negative value indicates the treatment difference is greater for younger compared to older participants.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups. Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||1.93|-7.05|0.23
70976749|NCT02939131|141461152|SUPERIORITY||Mean Difference (Final Values)|-2.77||||0.31|TWO_SIDED|95.0|-8.48|2.95||This is the test of the effect modification of viral suppression status|t-test, 2 sided||A negative value indicates a greater treatment difference among those with viral suppression at study entry compared to those without viral suppression.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups.Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||2.95|-8.48|0.31
71008504|NCT02355665|141524912|SUPERIORITY||Estimated Mean Difference|0.04||||0.635|TWO_SIDED|95.0|-0.28|0.36||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of dysphoric or depressed mood between treatments. The alternative hypothesis was a difference in distribution of the ratings of dysphoric or depressed mood between treatments.||0.36|-0.28|0.635
71095797|NCT01286324|141700179|SUPERIORITY|||||||0.45||||||Adjusted p-value based on a general linear model adjusted for group and the baseline of the measure|t-test, 2 sided|||P-value for Trait Subscale||||0.45
71095798|NCT01286324|141700180|SUPERIORITY|||||||0.11||||||P value is adjusted based on a general linear model adjusted for group and the baseline of the measure|t-test, 2 sided|||||||0.11
71095799|NCT05558410|141700192|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71095800|NCT05558410|141700193|SUPERIORITY|||||||0.2781|||||||ANCOVA|||||||0.2781
71095801|NCT05558410|141700194|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||<0.0001
71095802|NCT05558410|141700195|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||<0.0001
70976750|NCT02939131|141461152|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.72|TWO_SIDED|95.0|-4.29|5.95||This is the test of effect modification by QIDS-SR depression level at study entry.|t-test, 2 sided||A positive value indicates a greater treatment difference among those with moderate levels of depression compared to severe depression.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups.Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||5.95|-4.29|0.72
70976751|NCT02939131|141461152|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.91|TWO_SIDED|95.0|-5.91|5.31||This is the test of effect modification by mode of transmission|t-test, 2 sided||A negative value would indicate a greater treatment difference for those with perinatal HIV acquisition compared to behavioral acquisition.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups. Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||5.31|-5.91|0.91
70976752|NCT02939131|141461152|SUPERIORITY||Mean Difference (Final Values)|1.33||||0.57|TWO_SIDED|95.0|-3.91|6.57||This is the test of effect modification by HIV CDC stage level|t-test, 2 sided||A positive value would indicate a greater treatment effect for those with less than HIV CDC Stage 3 compared to those with CDC Stage 3 HIV illness.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups. Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||6.57|-3.91|0.57
70976753|NCT02939131|141461152|SUPERIORITY||Mean Difference (Final Values)|5.93||||0.1|TWO_SIDED|95.0|-1.73|13.59||This is the test of effect modification of CD4 Stage 3 at entry.|t-test, 2 sided||A positive value indicates a greater treatment effect among those with less than Stage 3 CD4 count at entry compared to those with Stage 3 CD4 count.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups. Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups..||13.59|-1.73|0.10
70976754|NCT02939131|141461152|SUPERIORITY||Mean Difference (Final Values)|-1.57||||0.58|TWO_SIDED|95.0|-7.74|4.6||This is the test of effect modification by Nadir Stage 3 level at study entry.|t-test, 2 sided||A negative value indicates a greater treatment effect among those with Stage 3 Nadir CD4 compare to those with less than Stage 3 Nadir CD4.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups. Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||4.60|-7.74|0.58
71008505|NCT02355665|141524913|SUPERIORITY||Estimated Mean Difference|-0.05||||0.273|TWO_SIDED|95.0|-0.42|0.32||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of dysphoric or depressed mood between treatments. The alternative hypothesis was a difference in distribution of the ratings of dysphoric or depressed mood between treatments.||0.32|-0.42|0.273
71095803|NCT05558410|141700196|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71095804|NCT05558410|141700197|SUPERIORITY||||||<|0.0001|||||||Pearson's chi-squared test|||||||<0.0001
71095805|NCT05558410|141700198|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71095806|NCT05558410|141700199|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||<0.0001
71095807|NCT05558410|141700200|SUPERIORITY|||||||0.0237|||||||Cochran-Mantel-Haenszel|||||||0.0237
71095808|NCT05558410|141700201|SUPERIORITY|||||||0.008|||||||Wilcoxon rank-sum|||||||0.0080
71095809|NCT02400580|141700206|OTHER|||||||0.517|||||||Fisher Exact|||||||0.517
71095810|NCT02400580|141700208|OTHER|||||||0.508|||||||Fisher Exact|||||||0.508
71095811|NCT01336972|141700214|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Test to compare Final Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||<0.05
71095812|NCT01336972|141700214|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Test to compare Final Treatment versus Baseline|paited t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||<0.05
71095813|NCT01336972|141700214|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Final Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
70976755|NCT02939131|141461153|SUPERIORITY||Mean Difference (Final Values)|-67.81||||0.01|TWO_SIDED|95.0|-116.53|-19.1||This is the test of effect modification by sex at birth.|t-test, 2 sided||A negative value indicates a greater treatment response (higher percent with response in COMB-R than in ESC group) among females compared to males.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||-19.10|-116.53|0.01
70976756|NCT02939131|141461153|SUPERIORITY||Mean Difference (Final Values)|43.08||||0.09|TWO_SIDED|95.0|-8.23|94.38||This is the test of effect modification by age group.|t-test, 2 sided||A positive value reflects a greater treatment effect among younger participants compared to older participants.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||94.38|-8.23|0.09
70976757|NCT02939131|141461153|SUPERIORITY||Mean Difference (Final Values)|2.18||||0.93|TWO_SIDED|95.0|-51.13|55.49||This is the test of effect modification by viral suppression status.|t-test, 2 sided||A positive value would reflect a greater treatment response among those with suppressed viral status at entry compared to those without viral suppression.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||55.49|-51.13|0.93
70976758|NCT02939131|141461153|SUPERIORITY||Mean Difference (Final Values)|3.36||||0.87|TWO_SIDED|95.0|-42.28|49.0||This is the test of effect modification by entry QIDS-SR depression level.|t-test, 2 sided||A positive value would indicate a greater treatment response for those with severe depressive symptoms at study entry compared to those with moderate depression.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||49.00|-42.28|0.87
71095814|NCT01336972|141700214|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Post Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71095815|NCT01336972|141700214|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Post Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71095816|NCT01336972|141700214|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Post Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71095817|NCT01336972|141700214|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71095818|NCT01336972|141700214|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71095819|NCT01336972|141700214|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||<0.05
71034231|NCT00318461|141578303|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-2.04|||<|0.0001||95.0|-2.63|-1.44|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||-1.44|-2.63|<0.0001
71034232|NCT00318461|141578303|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.33||||0.3047||95.0|-0.82|0.17|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose t as covariate.||0.17|-0.82|0.3047
71034233|NCT00318461|141578303|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.53|||<|0.0001||95.0|-2.12|-0.94|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||-0.94|-2.12|<0.0001
70976759|NCT02939131|141461153|SUPERIORITY||Mean Difference (Final Values)|41.65||||0.17|TWO_SIDED|95.0|-21.91|105.2||This is the test of effect modification by mode of transmission.|t-test, 2 sided||A positive value would indicate a larger treatment response for those with perinatal transmission compared to behavioral.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||105.20|-21.91|0.17
70976760|NCT02939131|141461153|SUPERIORITY||Mean Difference (Final Values)|49.4||||0.17|TWO_SIDED|95.0|-26.02|124.83||This is the test of effect modification by HIV CDC stage.|t-test, 2 sided||A positive value reflects a greater treatment response for those with HIV CDC Stage 3 classification compared to those with CDC classification less than Stage 3.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||124.83|-26.02|0.17
71034234|NCT00318461|141578303|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.18||||0.8079||95.0|-0.32|0.67|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||0.67|-0.32|0.8079
71095820|NCT01336972|141700214|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71095821|NCT01336972|141700214|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71095822|NCT01336972|141700214|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71095823|NCT01336972|141700215|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Final Treatment versus Baseline for all treatment groups|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71095824|NCT01336972|141700215|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Post Treatment versus Baseline for all treatment groups|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71095825|NCT01336972|141700215|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71095826|NCT01336972|141700215|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71095827|NCT01336972|141700215|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71034235|NCT00318461|141578304|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.93|||<|0.0001||95.0|-2.58|-1.28|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||-1.28|-2.58|<0.0001
71034236|NCT00318461|141578304|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.53||||0.0542||95.0|-1.08|0.01|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||0.01|-1.08|0.0542
71034237|NCT00318461|141578304|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.95|||<|0.0001||95.0|-2.6|-1.3|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||-1.30|-2.60|<0.0001
71034238|NCT00318461|141578304|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.55||||0.0451||95.0|-1.1|-0.01|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose t as covariate.||-0.01|-1.10|0.0451
71034239|NCT00318461|141578304|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.55|||<|0.0001||95.0|-2.2|-0.9|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||-0.90|-2.20|<0.0001
71034240|NCT00318461|141578304|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.15||||0.9006||95.0|-0.7|0.39|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||0.39|-0.70|0.9006
71095828|NCT01336972|141700215|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
70922241|NCT04310735|141335018|OTHER|Independent-samples t-tests were conducted to compare mean valence values during smoking-related cues between the Expect-Yes and Expect-No groups.||||||0.8|||||||t-test, 2 sided|Statistical significance was defined a priori as p\<0.05.||The null hypothesis was that there is no difference in the population means of the two groups.||||.80
70922242|NCT04310735|141335018|OTHER|Independent-samples t-tests were conducted to compare mean valence values during neutral cues between the Expect-Yes and Expect-No groups.||||||0.87||||||Statistical significance was defined a priori as p\<0.05.|t-test, 2 sided|||The null hypothesis was that there is no difference in the population means of the two groups.||||.87
70922243|NCT03517553|141335033|SUPERIORITY|||||||0.999||||||Threshold for statistical significance is P\<0.05|Kruskal-Wallis|||||||0.999
70922244|NCT03517553|141335033|SUPERIORITY|||||||0.768|||||||Kruskal-Wallis|||||||0.768
70922245|NCT03517553|141335034|SUPERIORITY|||||||0.869|||||||Kruskal-Wallis|||||||0.869
70922246|NCT03517553|141335034|SUPERIORITY|||||||0.813|||||||Kruskal-Wallis|||||||0.813
70922247|NCT03517553|141335034|SUPERIORITY|||||||0.978|||||||Kruskal-Wallis|||||||0.978
70922248|NCT03517553|141335034|SUPERIORITY|||||||0.731|||||||Kruskal-Wallis|||||||0.731
70922249|NCT03517553|141335034|SUPERIORITY|||||||0.703|||||||Kruskal-Wallis|||||||0.703
70922250|NCT03517553|141335034|SUPERIORITY|||||||0.909|||||||Kruskal-Wallis|||||||0.909
70922251|NCT05986565|141335118|SUPERIORITY|||||||0.587|||||||RMANOVA|1||||||0.587
70922252|NCT05986565|141335119|SUPERIORITY|||||||0.874|||||||RMANOVA|1||||||0.874
70922253|NCT05986565|141335120|SUPERIORITY|||||||0.946|||||||RMANOVA|1||||||0.946
70922254|NCT05986565|141335121|SUPERIORITY|||||||0.267|||||||t-test, 2 sided|24||||||0.267
70922255|NCT05986565|141335122|SUPERIORITY|||||||0.187|||||||t-test, 2 sided|df=25||||||0.187
70922256|NCT05986565|141335123|SUPERIORITY|||||||0.765|||||||t-test, 2 sided|df=24||||||0.765
70922257|NCT05986565|141335124|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|df=25||||||0.060
70922258|NCT05986565|141335125|SUPERIORITY|||||||0.608|||||||t-test, 2 sided|df=24||||||0.608
70922259|NCT05986565|141335126|SUPERIORITY|||||||0.638|||||||t-test, 2 sided|df=25||||||0.638
71095829|NCT01336972|141700215|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
70976761|NCT02939131|141461153|SUPERIORITY||Mean Difference (Final Values)|11.69||||0.71|TWO_SIDED|95.0|-70.76|94.15||This is the test of effect modification by CD4 Stage at study entry.|t-test, 2 sided||A positive value would reflect greater treatment response for those with CD4 Stage 3 compared to those with less than Stage 3 CD4.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||94.15|-70.76|0.71
70976762|NCT02939131|141461153|SUPERIORITY||Mean Difference (Final Values)|52.48||||0.02|TWO_SIDED|95.0|10.46|94.5||This is the test of effect modification by CD4 Nadir stage at study entry.|t-test, 2 sided||A positive value reflects a larger treatment response among those with Stage 3 Nadir CD4 compared to those with less than Stage 3 Nadir CD4.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||94.50|10.46|0.02
70976763|NCT02939131|141461154|SUPERIORITY||Mean Difference (Final Values)|-45.06||||0.09|TWO_SIDED|95.0|-97.84|7.72||This is the test of effect modification by sex at birth|t-test, 2 sided||A negative value indicates a greater treatment effect (higher percent with remission for COMB-R than for ESC) among females.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||7.72|-97.84|0.09
71008506|NCT02355665|141524914|SUPERIORITY||Estimated Mean Difference|-0.06||||0.879|TWO_SIDED|95.0|-0.4|0.28||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of dysphoric or depressed mood between treatments. The alternative hypothesis was a difference in distribution of the ratings of dysphoric or depressed mood between treatments.||0.28|-0.40|0.879
71095830|NCT01336972|141700216|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Final Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71095831|NCT01336972|141700216|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Post Treatment versus Baseline for all treatment groups|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71095832|NCT01336972|141700216|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71095833|NCT01336972|141700216|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding||||>0.05
71095834|NCT01336972|141700216|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71095835|NCT01336972|141700216|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71095836|NCT01336972|141700216|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||<0.05
71095837|NCT01336972|141700216|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71095838|NCT01336972|141700217|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired t-test|||Test to compare Final Treatment versus Baseline for all treatment groups||||<0.05
71095839|NCT01336972|141700217|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||paired t-test|||Test to compare Post Treatment versus Baseline||||>0.05
70976764|NCT02939131|141461154|SUPERIORITY||Mean Difference (Final Values)|1.41||||0.95|TWO_SIDED|95.0|-43.38|46.2||This is the test of effect modification by age group.|t-test, 2 sided||A positive value would reflect a larger treatment effect among younger participants compared to older participants.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||46.20|-43.38|0.95
70976765|NCT02939131|141461154|SUPERIORITY||Mean Difference (Final Values)|5.59||||0.79|TWO_SIDED|95.0|-40.47|51.65||This is the test of effect modification by viral suppression status.|Wilcoxon (Mann-Whitney)||A positive value would reflect a greater treatment effect among those with suppressed viral load compared to those without viral suppression.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||51.65|-40.47|0.79
70976766|NCT02939131|141461154|SUPERIORITY||Mean Difference (Final Values)|-15.97||||0.42|TWO_SIDED|95.0|-58.88|26.94||This is the test of effect modification by QIDS-SR level at entry.|t-test, 2 sided||A negative value would reflect a greater treatment effect among those with moderate depression symptomatology at entry compared to those with severe depression.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||26.94|-58.88|0.42
70976767|NCT02939131|141461154|SUPERIORITY||Mean Difference (Final Values)|9.99||||0.68|TWO_SIDED|95.0|-41.24|61.22||This is the test of effect modification by mode of transmission.|t-test, 2 sided||A positive value would reflect a greater treatment effect among those with perinatal transmission compared to behavioral transmission.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||61.22|-41.24|0.68
70976768|NCT02939131|141461154|SUPERIORITY||Mean Difference (Final Values)|-14.21||||0.57|TWO_SIDED|95.0|-70.62|42.2||This is the test of effect modification by HIV CDC stage.|t-test, 2 sided||A positive value would reflect a greater treatment response among those with HIV CDC Stage 3 classification compared to those with less than Stage 3 classification.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||42.20|-70.62|0.57
70976769|NCT02939131|141461154|SUPERIORITY||Mean Difference (Final Values)|-44.97||||0.26|TWO_SIDED|95.0|-141.12|51.17||This is the test of effect modification by CD4 Stage.|t-test, 2 sided||A negative value would reflect a greater treatment effect among those with less than Stage 3 CD4 levels compared to those with Stage 3 CD4.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||51.17|-141.12|0.26
70976770|NCT02939131|141461154|SUPERIORITY||Mean Difference (Final Values)|9.53||||0.72|TWO_SIDED|95.0|-52.97|72.02||This is the test of effect modification by CD4 nadir stage.|t-test, 2 sided||A positive value would reflect a greater treatment effect by those with Stage 3 CD4 Nadir compared to those with less than Stage 3.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||72.02|-52.97|0.72
70976771|NCT02939131|141461155|SUPERIORITY||Mean Difference (Final Values)|9.9||||0.26|TWO_SIDED|95.0|-8.4|28.1|||t-test, 2 sided||A positive value would indicate site-level percentages were higher in the COMB-R group and vice versa.|The percent of participants with alcohol use ever at week 24 were computed for each site. These site-level percentages were compared across treatment groups.||28.1|-8.4|0.26
70976772|NCT02939131|141461155|SUPERIORITY||Mean Difference (Final Values)|-6.3||||0.66|TWO_SIDED|95.0|-37.1|24.6|||t-test, 2 sided||A positive value would indicate site-level percentages were higher in the COMB-R group and vice versa.|The percent of participants with alcohol use ever at week 48 were computed for each site. These site-level percentages were compared across treatment groups.||24.6|-37.1|0.66
71095840|NCT01336972|141700217|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||paired t-test|||Test to compare Post Treatment versus Baseline||||>0.05
71095841|NCT01336972|141700217|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired t-test|||Test to compare Post Treatment versus Baseline||||<0.05
71095842|NCT01336972|141700217|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Test to compare treatment groups at Final Treatment||||||>0.05
70976773|NCT02939131|141461156|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.71|TWO_SIDED|95.0|-22.3|31.7|||t-test, 2 sided||A positive value indicates higher site-level percentages in the COMB-R group.|The percent of participants with regular frequency alcohol use at week 24 were computed for each site. These site-level percentages were compared across treatment groups.||31.7|-22.3|0.71
70976774|NCT02939131|141461156|SUPERIORITY||Mean Difference (Final Values)|26.7||||0.1|TWO_SIDED|95.0|-6.3|59.6|||t-test, 2 sided||A positive value would indicate higher site-level percentages in the COMB-R group.|The percent of participants at each site with regular alcohol use at week 48 was computed. These site-level percents were compared across treatments||59.6|-6.3|0.10
70976775|NCT02939131|141461157|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.09|TWO_SIDED|95.0|-2.6|0.2|||t-test, 2 sided||A positive value would indicate site level averages were higher in the COMB-R group and vice versa.|The average number of drinks per day reported at week 24 was computed for each site and these site-level averages were compared across treatments.||0.2|-2.6|0.09
70976776|NCT02939131|141461157|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.79|TWO_SIDED|95.0|-0.8|1.0|||t-test, 2 sided||A positive value would indicate site level averages were higher in the COMB-R group and vice versa.|The site-level average numbers of drinks per day reported at week 48 were computed and these site-level averages were compared across treatment groups.||1.0|-0.8|0.79
70976777|NCT02939131|141461158|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.87|TWO_SIDED|95.0|-0.9|0.8|||t-test, 2 sided||A positive value would indicate site level averages were higher in the COMB-R group anc vice versa|The site-level average number of days with binge drinking at week 24 were computed and these site-level averages were compared across treatments.||0.8|-0.9|0.87
70976778|NCT02939131|141461158|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED|95.0|-0.8|0.8|||t-test, 2 sided||A positive difference would indicate site level averages were higher in the COMB-R group and vice versa|The site-level average number of days with binge drinking reported at week 48 were computed and the site-level averages were compared across treatment groups.||0.8|-0.8|0.99
70976779|NCT02939131|141461159|SUPERIORITY||Mean Difference (Final Values)|3.2||||0.77|TWO_SIDED|95.0|-19.7|26.0|||t-test, 2 sided||A positive value would indicate site-level percentages were higher in the COMB-R group and vice versa.|The percent of participants with tobacco use ever at week 24 were computed for each site. These site-level percentages were compared across treatment groups.||26.0|-19.7|0.77
70976780|NCT02939131|141461159|SUPERIORITY||Mean Difference (Final Values)|14.7||||0.2|TWO_SIDED|95.0|-8.9|38.4|||t-test, 2 sided||A positive value would indicate site-level percentages were higher in the COMB-R group.|The percent of participants with tobacco use ever at week 48 were computed for each site. These site-level percentages were compared across treatment groups.||38.4|-8.9|0.20
70976781|NCT02939131|141461160|SUPERIORITY||Mean Difference (Final Values)|15.2||||0.09|TWO_SIDED|95.0|-2.8|33.3|||t-test, 2 sided||A positive difference would indicate the site level percentages were higher in the COMB-R group.|This is the analysis of regular use of tobacco at week 24. The percent of participants at each site with regular use was computed. These site-level percentages were compared across treatment groups.||33.3|-2.8|0.09
70976782|NCT02939131|141461160|SUPERIORITY||Mean Difference (Final Values)|20.6||||0.21|TWO_SIDED|95.0|-14.0|55.3|||t-test, 2 sided||A positive difference indicates site-level percentages were higher in the COMB-R group.|This is the analysis of regular frequency use of tobacco at week 48. Site level percentages of the numbers of participants with regular tobacco use were computed and compared across treatment groups.||55.3|-14.0|0.21
70976783|NCT02939131|141461161|SUPERIORITY||Mean Difference (Final Values)|7.9||||0.41|TWO_SIDED|95.0|-12.4|28.3|||t-test, 2 sided||A positive value would indicate higher site-level percentages in the COMB-R group and vice versa.|The site-level percentages of participants ever using marijuana (cannabis) reported at week 24 were computed and compared across treatment groups.||28.3|-12.4|0.41
70976784|NCT02939131|141461161|SUPERIORITY||Mean Difference (Final Values)|13.0||||0.26|TWO_SIDED|95.0|-10.9|36.8|||t-test, 2 sided||A positive value would indicate higher site-level percentages in the COMB-R group and vice versa.|The site-level percentages of participants ever using marijuana (cannabis) reported at week 48 were computed and compared across treatment groups.||36.8|-10.9|0.26
70976785|NCT02939131|141461161|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.69|TWO_SIDED|95.0|-20.2|29.5|||t-test, 2 sided||A positive difference would indicate higher site-level percentages in the COMB-R group and vice versa.|The site-level percentages of participants ever using any illegal substance excluding marijuana (cannabis) reported at week 24 were computed and compared across treatment groups.||29.5|-20.2|0.69
70976786|NCT02939131|141461161|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.96|TWO_SIDED|95.0|-24.8|23.5|||t-test, 2 sided||A positive difference would indicate higher site-level percentages in the COMB-R group and vice versa.|The site-level percentages of participants ever using any illegal substance excluding marijuana (cannabis) reported at week 48 were computed and compared across treatment groups.||23.5|-24.8|0.96
70976787|NCT02939131|141461162|SUPERIORITY||Mean Difference (Final Values)|10.1||||0.53|TWO_SIDED|95.0|-23.9|44.1|||t-test, 2 sided||A positive difference indicates a higher site-level percentage of participants reporting regular use fof marijuana in the COMB-R group compared to the ESC group.|This is the analysis for regular use of marijuana (cannabis) at week 24. The percent of participants at each site reporting regular use (of those reporting any use) was computed. These site-level percentages were averaged and compared across treatments.||44.1|-23.9|0.53
71095843|NCT01336972|141700217|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|paired t-test|||||||>0.05
71095844|NCT01336972|141700217|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||||||>0.05
71095845|NCT01336972|141700217|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||||||>0.05
70976788|NCT02939131|141461162|SUPERIORITY||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-35.1|34.9|||t-test, 2 sided||A positive difference would indicate higher site-level percentages of regular use of marijuana (cannabis) in the COMB-R group compared to the ESC group.|This is the analysis of regular use of marijuana (cannabis) at week 48. Of those reporting ever used, the percent at each site reporting regular use was computed. These site-level percentages were averaged and compared across treatment groups.||34.9|-35.1|1.0
70976789|NCT02939131|141461162|SUPERIORITY||Mean Difference (Final Values)|24.7||||0.18|TWO_SIDED|95.0|-16.2|65.5|||t-test, 2 sided||A positive difference would indicate higher site-level percentages of regular substance use in the COMB-R group compared to the ESC group.|This is the analysis of regular use of any illegal substance, excluding cannabis, at week 24. Of those reporting ever used, the percent at each site reporting regular use was computed. These site-level percentages were averaged and compared across treatment groups.||65.5|-16.2|0.18
70976790|NCT02939131|141461162|SUPERIORITY||Mean Difference (Final Values)|-18.3||||0.34|TWO_SIDED|95.0|-59.5|22.9|||t-test, 2 sided||A positive difference would indicate higher site-level percentages of regular substance use in the COMB-R group compared to the ESC group.|This is the analysis of regular use of any illegal substance, excluding cannabis, at week 48. Of those reporting ever used, the percent at each site reporting regular use was computed. These site-level percentages were averaged and compared across treatment groups.||22.9|-59.5|0.34
70976791|NCT02939131|141461163|SUPERIORITY||Mean Difference (Final Values)|13.4||||0.29|TWO_SIDED|95.0|-12.9|39.6|||t-test, 2 sided||A positive value would indicate higher site-level percents in the COMB-R group.|This is the analysis for week 24. The percentage of participants at a site who reported using sex as a commodity was calculated and the site-level percentages were averaged and compared across treatments.||39.6|-12.9|0.29
70976792|NCT02939131|141461163|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.7|TWO_SIDED|95.0|-17.0|24.5|||t-test, 2 sided||A positive difference would indicate site-level percentages were higher in the COMB-R group|This is the analysis for week 48. The percentage of participants at a site who reported using sex as a commodity was calculated and the site-level percentages were averaged and compared across treatments.||24.5|-17.0|0.70
70976793|NCT02939131|141461164|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.71|TWO_SIDED|95.0|-13.7|19.4|||t-test, 2 sided||A positive difference indicates the site-level averages were higher for the COMB-R group.|This is the analysis for week 24. Scores were averaged by site and the site-level averages were averaged and compared across treatment groups.||19.4|-13.7|0.71
70976794|NCT02939131|141461164|SUPERIORITY||Mean Difference (Final Values)|-4.7||||0.44|TWO_SIDED|95.0|-17.5|8.1|||t-test, 2 sided||A positive value would indicate site-level averages were higher in the COMB-R group.|This is the analysis for week 48. Scores were averaged by site and the site-level averages were averaged and compared across treatment groups.||8.1|-17.5|0.44
70976795|NCT02939131|141461165|SUPERIORITY||Mean Difference (Final Values)|7.3||||0.23|TWO_SIDED|95.0|-5.3|19.8|||t-test, 2 sided||A positive value would indicate site-level averages were higher in the COMB-R group.|This is the analysis for week 24. Scores were averaged by site and the site-level averages were averaged and compared across treatment groups.||19.8|-5.3|0.23
70976796|NCT02939131|141461165|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.73|TWO_SIDED|95.0|-17.5|12.7|||t-test, 2 sided||A positive difference would indicate site-level averages were higher in the COMB-R group.|This is the analysis for week 48. Scores were averaged by site and the site-level averages were averaged and compared across treatment groups.||12.7|-17.5|0.73
70976797|NCT02939131|141461166|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.24|TWO_SIDED|95.0|-0.4|1.5|||t-test, 2 sided||A positive value would indicate site-level averages were higher in COMB-R group.|This is the analysis for week 24. Numbers of partners were averaged by site and the site-level averages were averaged and compared across treatment groups.||1.5|-0.4|0.24
70976798|NCT02939131|141461166|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.22|TWO_SIDED|95.0|-0.3|1.0|||t-test, 2 sided||A positive difference indicates site-level averages were higher in the COMB-R group.|This is the analysis for week 48. Numbers of partners were averaged by site and the site-level averages were averaged and compared across treatment groups.||1.0|-0.3|0.22
71095846|NCT01336972|141700217|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||||||>0.05
70976799|NCT02939131|141461167|SUPERIORITY||Mean Difference (Final Values)|-8.3||||0.57|TWO_SIDED|95.0|-40.4|23.9|||t-test, 2 sided||A positive value would indicate higher site-level percents of low frequency condom use in COMB-R treatment group and vice versa.|This is the analysis for week 24 data. We computed the percent of participants reporting low frequency of condom use in past three months by site, averaged the site-level percents and compared these averages across treatment arms.||23.9|-40.4|0.57
70976800|NCT02939131|141461167|SUPERIORITY||Mean Difference (Final Values)|-21.8||||0.15|TWO_SIDED|95.0|-53.1|9.5|||t-test, 2 sided||A positive difference would indicate higher site-level percentages in the COMB-R group and vice versa.|This is the analysis for week 48 data. We computed the percent of participants reporting low frequency of condom use in past three months by site, averaged the site-level percents and compared these averages across treatment arms.||9.5|-53.1|0.15
71095847|NCT01336972|141700217|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||||||<0.05
71095848|NCT01336972|141700221|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired t-test|||Comparison of all treatment groups versus Baseline at Final Treatment||||<0.05
71095849|NCT01336972|141700221|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired t-test|||Comparison of all treatment groups versus Baseline at Post Treatment||||<0.05
71095850|NCT01336972|141700221|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||>0.05
71095851|NCT01336972|141700221|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||<0.05
70976801|NCT02939131|141461168|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.65|TWO_SIDED|95.0|-40.9|27.2|||t-test, 2 sided||A positive difference would indicate site level percents were higher in the COMB-R group and vice versa.|We computed the site-level percentages of participants reporting low frequency condom use at week 24, then averaged the site-level percentages by treatment group and compared these group average percents.||27.2|-40.9|0.65
70976802|NCT02939131|141461168|SUPERIORITY||Mean Difference (Final Values)|-37.8||||0.02|TWO_SIDED|95.0|-69.7|-5.8|||t-test, 2 sided||A positive difference would indicate site-level percentages were higher in the COMB-R group and vice versa.|We computed the site-level percentages of participants reporting low frequency condom use at week 48, then averaged the site-level percentages by treatment group and compared these group average percents.||-5.8|-69.7|0.02
70976803|NCT02939131|141461169|SUPERIORITY||Mean Difference (Final Values)|2.5||||0.33|TWO_SIDED|95.0|-3.0|8.1|||t-test, 2 sided||A positive difference indicates COMB-R participants attended more sessions than ESC|We averaged the number of counseling sessions for each site and compared these site-level averages.||8.1|-3.0|0.33
70976804|NCT02939131|141461174|SUPERIORITY||Mean Difference (Final Values)|18.7||||0.06|TWO_SIDED|95.0|-0.9|38.2|||t-test, 2 sided||A positive difference indicates more participants in the COMB-R group were taking medications, based on site-level percentages.|This is the analysis for the percent of participants on any psychiatric medication at week 24. Site-level percentages were compared across treatments.||38.2|-0.9|0.06
70976805|NCT02939131|141461174|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.06|TWO_SIDED|95.0|-0.7|35.5|||t-test, 2 sided||A positive difference means the site-level percentages of those taking medications were higher in the COMB-R group.|This is the analysis of the percent of participants on antidepressant medications. Site-level percentages were compared across treatments.||35.5|-0.7|0.06
70976806|NCT02939131|141461174|SUPERIORITY||Mean Difference (Final Values)|22.4||||0.02|TWO_SIDED|95.0|4.2|40.6|||t-test, 2 sided||A positive difference indicates the site-level percentages of those taking medications were higher in the COMB-R group.|This is the analysis of the percent of participants on SSRI antidepressant medications. Site-level percentages were compared across treatments.||40.6|4.2|0.02
70976807|NCT02939131|141461174|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.54|TWO_SIDED|95.0|-17.3|9.6|||t-test, 2 sided||A positive difference would indicate site-level percentages of those on medication were higher in the COMB-R group.|This is the analysis of the percent of participants on non-SSRI antidepressant medications. Site-level percentages were compared across treatments.||9.6|-17.3|0.54
71034241|NCT00318461|141578305|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.13||||0.8871||95.0|-0.62|0.36|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.36|-0.62|0.8871
71095852|NCT01336972|141700221|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||>0.05
71095853|NCT01336972|141700221|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
71095854|NCT01336972|141700221|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
70976808|NCT02939131|141461174|SUPERIORITY||Mean Difference (Final Values)|-5.0||||0.6|TWO_SIDED|95.0|-25.4|15.4|||t-test, 2 sided||A positive value would indicate the site-level percentages of those on medications were higher in the COMB-R group.|This is the analysis of the percent of participants on non-antidepressant psychiatric medications. Site-level percentages were compared across treatments.||15.4|-25.4|0.60
70976809|NCT02939131|141461175|SUPERIORITY||Mean Difference (Final Values)|-3.8||||0.77|TWO_SIDED|95.0|-32.5|24.8|||t-test, 2 sided||A positive difference would indicate more time on medication in the COMB-R group.|This is the analysis comparing site-level mean percents of study time on any psychiatric medication across treatment groups.||24.8|-32.5|0.77
70976810|NCT02939131|141461175|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.91|TWO_SIDED|95.0|-37.3|33.5|||t-test, 2 sided||A positive difference would indicate more study time on medication in the COMB-R group.|This is the analysis comparing site-level mean percents of study time on single SSRI psychiatric medication across treatment groups.||33.5|-37.3|0.91
71095855|NCT01336972|141700221|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
71095856|NCT01336972|141700222|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Paired t-test|||Test to compare Final Treatment versus Baseline for all treatment groups||||<0.05
71095857|NCT01336972|141700222|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||<0.05
71095858|NCT01336972|141700222|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||>0.05
71095859|NCT01336972|141700222|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||<0.05
71095860|NCT01336972|141700222|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Paired t-test|||Test to compare PostTreatment versus Baseline for all treatment groups||||>0.05
71095861|NCT01336972|141700222|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
71095862|NCT01336972|141700222|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
71095863|NCT01336972|141700222|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||<0.05
70976811|NCT02939131|141461175|SUPERIORITY||Mean Difference (Final Values)|-16.7||||0.4|TWO_SIDED|95.0|-60.2|26.9|||t-test, 2 sided||A positive value would indicate more time on medication in the COMB-R group.|This is the analysis comparing site-level mean percents of study time on SSRI+other psychiatric medication across treatment groups.||26.9|-60.2|0.40
70976812|NCT02939131|141461175|SUPERIORITY||Mean Difference (Final Values)|-13.5||||0.52|TWO_SIDED|95.0|-67.0|40.1|||t-test, 2 sided||A positive difference would indicate more time on medication in COMB-R group.|This is the analysis comparing site-level mean percents of study time on a single non-SSRI psychiatric medication across treatment groups.||40.1|-67.0|0.52
70976813|NCT02939131|141461175|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.96|TWO_SIDED|95.0|-778.0|785.7|||t-test, 2 sided|Because of sparseness, the confidence intervals for this site-level analysis are very large.|A positive difference indicates more time on medication in the COMB-R group. There was data from only one site in the ESC group and 2 sites in the COMB-R group. The confidence interval for the difference is quite large and the test is unreliable.|This is the analysis comparing site-level mean percents of study time on non-SSRI+other psychiatric medication across treatment groups. This analysis is unstable because of sparseness.||785.7|-778.0|0.96
70976814|NCT02939131|141461175|SUPERIORITY||Mean Difference (Final Values)|-4.2||||0.74|TWO_SIDED|95.0|-31.4|23.0|||t-test, 2 sided||A positive difference would reflect more time on medications in the COMB-R group|This is the analysis comparing site-level mean percents of study time on antidepressant medication across treatment groups.||23.0|-31.4|0.74
70976815|NCT02939131|141461176|SUPERIORITY||Mean Difference (Final Values)|2.7||||0.29|TWO_SIDED|95.0|-2.8|8.2|||t-test, 2 sided||A positive difference would indicate the site level average interim counseling sessions was higher in the COMB-R group.|We compared the site-level average number of interim counseling sessions between treatment groups.||8.2|-2.8|0.29
70976816|NCT02939131|141461178|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.03|TWO_SIDED|95.0|0.02|0.38|||t-test, 2 sided||A positive difference indicates higher site-level averages in the COMB-R group.|The average score for all participants at each site was computed. These site-level averages were compared across treatment groups.||0.38|0.02|0.03
70976817|NCT02939131|141461179|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.69|TWO_SIDED|95.0|-0.43|0.29|||t-test, 2 sided||A positive difference would indicate the site-level averages were higher in the COMB-R group compared to the ESC group and vice versa|The average of scores for all participants' clinicians at each site was computed and these site-level averages were compared across treatments.||0.29|-0.43|0.69
70976818|NCT02939131|141461180|SUPERIORITY||Mean Difference (Final Values)|0.65||||0.004|TWO_SIDED|95.0|0.26|1.03|||t-test, 2 sided||A positive difference would indicate site-level averages were higher for the COMB-R group than the ESC group and vice versa.|The average scores for all participants' prescribing clinicians at each site were computed and these site-level averages were compared across treatment groups.||1.03|0.26|0.004
70976819|NCT02939131|141461181|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.|Mean Difference (Final Values)|0.16||||0.98|TWO_SIDED|95.0|-14.04|14.36|||t-test, 2 sided||We subtract group mean for ESC from group mean for COMB-R. The group means are the means of the site-level percentages of participants with events.|This is the analysis of new Grade 3+ signs/symptoms through week 24. The percent of participants at each site with at least one such event was computed. The average of these site-level percents was calculated for each treatment arm. These averages were compared.||14.36|-14.04|0.98
70976820|NCT02939131|141461181|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.|Mean Difference (Final Values)|2.57||||0.6|TWO_SIDED|95.0|-7.85|12.98|||t-test, 2 sided||We subtracted the group mean for the ESC group from that of the COMB-R group. The group mean is the mean of the site-specific percentages of participants with events.|This is the analysis of new Grade 3+ diagnoses through week 24.The percent of participants at each site with at least one such event was computed. The average of these site-level percents was calculated for each treatment arm. These averages were compared.||12.98|-7.85|0.60
70976821|NCT02939131|141461181|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.The group mean is the mean of the site-specific percentages of participants with events as defined above.|Mean Difference (Final Values)|4.4||||0.17|TWO_SIDED|95.0|-2.21|11.02|||t-test, 2 sided||The ESC group mean percent of participants reporting a trigger event was subtracted from the COMB-R group mean.|This is the analysis of the triggering events (psychiatric hospitalizations or suicide attempts) through week 24. A participant is counted once if they had reported any such event prior to the upper bound of the week 24 window. The percent of participants at each site with at least one such event were computed.The average of these site-level percents was calculated for each treatment arm. These averages were compared.||11.02|-2.21|0.17
71034242|NCT00318461|141578305|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.12||||0.8695||95.0|-0.51|0.27|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.27|-0.51|0.8695
71034243|NCT00318461|141578305|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.03||||0.9994||95.0|-0.46|0.52|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.52|-0.46|0.9994
71095864|NCT01336972|141700223|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired te-test|||Test to compare Final Treatment versus Baseline for all treatment groups||||<0.05
71095865|NCT01336972|141700223|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||>0.05
70976822|NCT02939131|141461182|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.98|TWO_SIDED|95.0|-13.85|14.13|||t-test, 2 sided||A positive difference indicates more participants with events in the COMB-R group.|This is the analysis of new Grade 3+ signs/symptoms through week 48. The percent of participants at each site with at least one such event was computed. The average of these site-level percents was calculated for each treatment arm. These averages were compared.||14.13|-13.85|0.98
70976823|NCT02939131|141461182|SUPERIORITY||Mean Difference (Final Values)|5.64||||0.4|TWO_SIDED|95.0|-8.6|19.89|||t-test, 2 sided||A positive difference indicates more participants with events in the COMB-R group.|This is the analysis of new Grade 3+ diagnoses through week 48. The percent of participants at each site with at least one such event was computed. The average of these site-level percents was calculated for each treatment arm. These averages were compared.||19.89|-8.60|0.40
70976824|NCT02939131|141461182|SUPERIORITY||Mean Difference (Final Values)|3.01||||0.44|TWO_SIDED|95.0|-5.27|11.29|||t-test, 2 sided||A positive difference indicates more participants with events in the COMB-R group.|This is the analysis of new trigger events through week 48. The percent of participants at each site with at least one such event was computed. The average of these site-level percents was calculated for each treatment arm. These averages were compared.||11.29|-5.27|0.44
70976825|NCT00988247|141461216|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo]|-0.97|||<|0.001|TWO_SIDED|95.0|-1.5|-0.5|||ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, treatment, week and the treatment by week interaction.||||-0.5|-1.5|<0.001
71034244|NCT00318461|141578305|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.04||||0.9984||95.0|-0.35|0.43|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.43|-0.35|0.9984
70976826|NCT00988247|141461217|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo]|-0.96|||<|0.001|TWO_SIDED|95.0|-1.4|-0.5|||ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, treatment, week and the treatment by week interaction.||||-0.5|-1.4|<0.001
70976827|NCT00988247|141461218|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo]|-1.09|||<|0.001|TWO_SIDED|95.0|-1.6|-0.6|||ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, treatment, week and the treatment by week interaction.||||-0.6|-1.6|<0.001
71034245|NCT00318461|141578305|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.21||||0.6201||95.0|-0.28|0.7|||ANCOVA|||Change in mean prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.70|-0.28|0.6201
71034246|NCT00318461|141578305|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.21||||0.4831||95.0|-0.18|0.6|||ANCOVA|||Change in mean prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.60|-0.18|0.4831
71034247|NCT00318461|141578306|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 1.8 mg+metformin was superior to placebo + metformin. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-0.83|||<|0.0001||95.0|-1.07|-0.59|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.59|-1.07|<0.0001
71034248|NCT00318461|141578306|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 1.8 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 1.8 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|-0.08|||<|0.0001||95.0|-0.28|0.12|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||0.12|-0.28|<0.0001
71095866|NCT01336972|141700223|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||>0.05
71095867|NCT01336972|141700223|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||>0.05
70976828|NCT00988247|141461219|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo]|-1.1|||<|0.001|TWO_SIDED|95.0|-1.6|-0.6|||ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, treatment, week and the treatment by week interaction.||||-0.6|-1.6|<0.001
70976829|NCT00988247|141461220|SUPERIORITY_OR_OTHER_LEGACY||treatment difference|-0.3||||0.143|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|ANCOVA with treatment, baseline and pooled center in the model.||||0.1|-0.7|0.143
70976830|NCT00988247|141461221|SUPERIORITY_OR_OTHER_LEGACY||treatment difference|-0.49||||0.13|TWO_SIDED|95.0|-1.1|0.1|||ANCOVA|ANCOVA with treatment, baseline and pooled center in the model.||||0.1|-1.1|0.130
70976831|NCT01169779|141461231|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.099||0.0004|TWO_SIDED|95.0|-0.551|-0.162||Statistical testing:2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0,\>=8.0%), sulfonylurea use (Yes,No), country as fixed effects, baseline HbA1c as covariate.|ANCOVA|||To detect a difference of 0.5% in change in HbA1c at Week 24 between lixisenatide arm and placebo arm, 190 patients per group would provide a power of 96% assuming common standard deviation of 1.3% with 2-sided test at 5% significance level.||-0.162|-0.551|0.0004
70976832|NCT00849667|141461270|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.4513|TWO_SIDED|95.0|0.81|1.21|||Log Rank|One-sided log rank test||||1.21|0.81|0.4513
70976833|NCT00849667|141461270|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0761|TWO_SIDED|95.0|0.7|1.06|||Log Rank|One-sided log rank test||||1.06|0.70|0.0761
70976834|NCT00849667|141461271|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.4823|TWO_SIDED|95.0|0.78|1.27|||Log Rank|One-sided log rank test||||1.27|0.78|0.4823
70976835|NCT00849667|141461271|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1616|TWO_SIDED|95.0|0.68|1.13|||Log Rank|One-sided log rank test||||1.13|0.68|0.1616
71034249|NCT00318461|141578306|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 1.2 mg+metformin was superior to placebo + metformin. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-0.81|||<|0.0001||95.0|-1.05|-0.57|||ANCOVA|||Change in HbA1c from baseline to end of treatment was at 104 weeks analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.57|-1.05|<0.0001
71034250|NCT00318461|141578306|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 1.2 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 1.2 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|-0.07|||<|0.0001||95.0|-0.27|0.13|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||0.13|-0.27|<0.0001
71034251|NCT00318461|141578306|NON_INFERIORITY_OR_EQUIVALENCE|"Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 0.6 mg+metformin was superior to placebo + metformin.~Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%."|Estimated treatment difference, LS Mean|-0.61|||<|0.0001||95.0|-0.85|-0.37|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.37|-0.85|<0.0001
71034252|NCT00318461|141578306|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 0.6 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 0.6 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|0.14||||0.0052||95.0|-0.06|0.34|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||0.34|-0.06|0.0052
71034253|NCT00318461|141578306|NON_INFERIORITY_OR_EQUIVALENCE|A test for superiority of glimepiride+metformin to placebo metformin was performed to verify assay sensitivity. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-0.75|||<|0.0001||95.0|-0.99|-0.51|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.51|-0.99|<0.0001
71034254|NCT00318461|141578307|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.24||||0.5282||95.0|-0.74|0.26|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.26|-0.74|0.5282
71095868|NCT01336972|141700223|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired t-test|||Test to compare Post Treatment versus Baseline||||<0.05
71095869|NCT01336972|141700223|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||paired t-test|||Test to compare Post Treatment versus Baseline||||>0.05
71095870|NCT01336972|141700223|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Paired t-test|||Test to compare Post Treatment versus Baseline||||>0.05
71095871|NCT01336972|141700223|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
70976836|NCT00849667|141461272|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.2938|TWO_SIDED|95.0|0.72|1.21|||Log Rank|One-sided log-rank test||||1.21|0.72|0.2938
70976837|NCT00849667|141461272|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0318|TWO_SIDED|95.0|0.58|1.02|||Log Rank|One-sided log-rank test||||1.02|0.58|0.0318
70976838|NCT00849667|141461273|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.5636|TWO_SIDED|95.0|0.85|1.21|||Log Rank|One-sided log-rank test||||1.21|0.85|0.5636
70976839|NCT00849667|141461273|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.156|TWO_SIDED|95.0|0.76|1.09|||Log Rank|One-sided log-rank test||||1.09|0.76|0.1560
70976840|NCT00849667|141461275|SUPERIORITY||Difference in percentage|1.8||||0.6864|TWO_SIDED|95.0|-5.4|9.0|||Cochran-Mantel-Haenszel|||||9.0|-5.4|0.6864
70976841|NCT00849667|141461275|SUPERIORITY||Difference in percentage|2.4||||0.4923|TWO_SIDED|95.0|-4.8|9.6|||Cochran-Mantel-Haenszel|||||9.6|-4.8|0.4923
70976842|NCT00849667|141461278|SUPERIORITY||Difference in percentage|-0.4||||0.8106|TWO_SIDED|95.0|-4.9|4.1|||Cochran-Mantel-Haenszel|||50% serological response||4.1|-4.9|0.8106
70976843|NCT00849667|141461278|SUPERIORITY||Difference in percentage|5.1||||0.0064|TWO_SIDED|95.0|1.4|8.8|||Cochran-Mantel-Haenszel|||50% serological response||8.8|1.4|0.0064
70976844|NCT00849667|141461278|SUPERIORITY||Difference in percentage|4.1||||0.3005|TWO_SIDED|95.0|-2.0|10.2|||Cochran-Mantel-Haenszel|||75% serological response||10.2|-2.0|0.3005
70976845|NCT00849667|141461278|SUPERIORITY||Difference in percentage|3.7||||0.2445|TWO_SIDED|95.0|-2.5|9.9|||Cochran-Mantel-Haenszel|||75% serological response||9.9|-2.5|0.2445
70976846|NCT00849667|141461278|SUPERIORITY||Difference in percentage|5.3||||0.2797|TWO_SIDED|95.0|-2.8|13.4|||Cochran-Mantel-Haenszel|||Serologic response leading to normalization||13.4|-2.8|0.2797
70976847|NCT00849667|141461278|SUPERIORITY||Difference in percentage|4.9||||0.2136|TWO_SIDED|95.0|-3.2|13.0|||Cochran-Mantel-Haenszel|||Serologic response leading to normalization||13.0|-3.2|0.2136
70976848|NCT00531960|141461302|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.806|TWO_SIDED|95.0|0.7|1.59|||Log Rank|||||1.59|0.70|0.8060
70976849|NCT00531960|141461304|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||0.4063|TWO_SIDED|95.0|0.75|2.05|||Log Rank|||||2.05|0.75|0.4063
70976850|NCT00531960|141461305|SUPERIORITY_OR_OTHER||Difference in Response Rates|-17.28||||0.0444|TWO_SIDED|95.0|-34.8|0.3|||Chi-squared||The 95% CI for the difference of 2 rates was determined by using the Hauck-Anderson method.|||0.3|-34.8|0.0444
70976851|NCT00531960|141461306|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|-12.2||||0.0944|TWO_SIDED|95.0|-27.3|2.8|||Chi-squared||The 95% CI for the difference in disease control was determined using the Hauck-Anderson method.|||2.8|-27.3|0.0944
70976852|NCT01486199|141461358|EQUIVALENCE|alpha=0.05||||||0.002|||||||t-test, 2 sided|||Comparing absorptive clearance in CF children vs adult controls||||0.002
70976853|NCT01486199|141461359|EQUIVALENCE|alpha = 0.05||||||0.2|||||||t-test, 2 sided|||Comparison of mucociliary clearance in CF children compared to healthy adults||||0.20
70976854|NCT01486199|141461360|EQUIVALENCE|alpha=0.05||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Comparing absorptive clearance at t=0 vs t=2 years in pediatric CF subjects||||0.24
70976855|NCT01486199|141461361|EQUIVALENCE|alpha=0.05||||||0.87|||||||Wilcoxon (Mann-Whitney)|||Comparing mucociliary clearance at t=0 and t=2yrs in pediatric CF subjects||||0.87
70976856|NCT01400932|141461368|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.0|||<|0.001|TWO_SIDED|95.0|-26.2|-15.8|||ANCOVA|||||-15.8|-26.2|<0.001
70976857|NCT01400932|141461369|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 1|ANCOVA|||||||<0.001
70976858|NCT01400932|141461369|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 2|ANCOVA|||||||<0.001
70976859|NCT01400932|141461369|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4|ANCOVA|||||||<0.001
70976860|NCT01400932|141461369|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8|ANCOVA|||||||<0.001
70976861|NCT01400932|141461370|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 1; IL|ANCOVA|||||||<0.001
70976862|NCT01400932|141461370|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 2; IL|ANCOVA|||||||<0.001
70976863|NCT01400932|141461370|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4; IL|ANCOVA|||||||<0.001
70976864|NCT01400932|141461370|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8; IL|ANCOVA|||||||<0.001
70976865|NCT01400932|141461370|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12; IL|ANCOVA|||||||<0.001
70976866|NCT01400932|141461370|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||Week 1; NIL|ANCOVA|||||||0.007
70976867|NCT01400932|141461370|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||Week 2; NIL|ANCOVA|||||||0.008
70976868|NCT01400932|141461370|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4; NIL|ANCOVA|||||||<0.001
70976869|NCT01400932|141461370|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8; NIL|ANCOVA|||||||<0.001
70976870|NCT01400932|141461370|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12; NIL|ANCOVA|||||||<0.001
70976871|NCT01400932|141461371|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 1; Total|ANCOVA|||||||<0.001
70976872|NCT01400932|141461371|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 2; Total|ANCOVA|||||||<0.001
70976873|NCT01400932|141461371|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4; Total|ANCOVA|||||||<0.001
70976874|NCT01400932|141461371|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8; Total|ANCOVA|||||||<0.001
70976875|NCT01400932|141461371|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12; Total|ANCOVA|||||||<0.001
71095872|NCT01336972|141700223|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
70976876|NCT01400932|141461371|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 1; IL|ANCOVA|||||||<0.001
70976877|NCT01400932|141461371|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 2; IL|ANCOVA|||||||<0.001
70976878|NCT01400932|141461371|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4; IL|ANCOVA|||||||<0.001
70976879|NCT01400932|141461371|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8; IL|ANCOVA|||||||<0.001
70976880|NCT01400932|141461371|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12; IL|ANCOVA|||||||<0.001
70976881|NCT01400932|141461371|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Week 1; NIL|ANCOVA|||||||0.002
70976882|NCT01400932|141461371|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 2; NIL|ANCOVA|||||||<0.001
70976883|NCT01400932|141461371|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4; NIL|ANCOVA|||||||<0.001
70976884|NCT01400932|141461371|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8; NIL|ANCOVA|||||||<0.001
70976885|NCT01400932|141461371|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12; NIL|ANCOVA|||||||<0.001
70976886|NCT01400932|141461372|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
70976887|NCT01400932|141461373|SUPERIORITY_OR_OTHER|||||||0.174||95.0||||Week 1|ANCOVA|||||||0.174
70976888|NCT01400932|141461373|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||Week 2|ANCOVA|||||||0.013
70976889|NCT01400932|141461373|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Week 4|ANCOVA|||||||0.001
70976890|NCT01400932|141461373|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Week 8|ANCOVA|||||||0.001
70976891|NCT01400932|141461373|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12|ANCOVA|||||||<0.001
70976892|NCT01400932|141461374|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 1|ANCOVA|||||||<0.001
70976893|NCT01400932|141461374|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 2|ANCOVA|||||||<0.001
70976894|NCT01400932|141461374|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4|ANCOVA|||||||<0.001
70976895|NCT01400932|141461374|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8|ANCOVA|||||||<0.001
70976896|NCT01400932|141461374|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12|ANCOVA|||||||<0.001
70976897|NCT01276821|141461384|NON_INFERIORITY_OR_EQUIVALENCE|Non - Inferiority Analysis|Mean Difference (Final Values)|1.33|STANDARD_DEVIATION|1.3|<|0.05|TWO_SIDED|95.0|0.78|1.82|||t-test, 2 sided|||"Null Hypothesis Efficacy of nebulised hypertonic saline (3%) with L-Epinephrine is not higer than as compared to L-Epinephrine given with 0.9% normal saline in the management of children aged 6 weeks to 24 months with mild to moderately severe bronchiolitis.~Alternate Hypothesis:~Nebulised hypertonic saline (3%) with L-Epinephrine is superior to 0.9% Normal saline with L-Epinephrine in the management of children aged 6 weeks to 24 months with mild to moderately severe bronchiolitis."||1.82|0.78|<0.05
70976898|NCT01879410|141461442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|||<|0.001|TWO_SIDED|95.0|0.063|0.139|||ANCOVA||Least squares mean difference=UMEC/VI 62.5/25 mcg minus FSC 250/50 mcg.|||0.139|0.063|<0.001
70976899|NCT02649634|141461444|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05.|Mixed Models Analysis|||Linear mixed modelling (LMM) was used||||>.05
70976900|NCT02649634|141461445|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used||||>.05
70976901|NCT02649634|141461446|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.||||||0.65|||||||t-test, 2 sided|||Treatment adherence was analyzed via an independent sample t-test comparing the groups on mean number of TrymGym sessions missed.||||.65
70976902|NCT02649634|141461447|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used||||>.05
71008507|NCT02355665|141524915|SUPERIORITY||Estimated Mean Difference|0.02||||0.823|TWO_SIDED|95.0|-0.28|0.32||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of dysphoric or depressed mood between treatments. The alternative hypothesis was a difference in distribution of the ratings of dysphoric or depressed mood between treatments.||0.32|-0.28|0.823
71008508|NCT02355665|141524916|SUPERIORITY||Estimated Mean Difference|0.0||||0.804|TWO_SIDED|95.0|-0.4|0.4||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of insomnia between treatments. The alternative hypothesis was a difference in distribution of the ratings of insomnia between treatments.||0.40|-0.40|0.804
71008509|NCT02355665|141524917|SUPERIORITY||Estimated Mean Difference|0.13||||0.438|TWO_SIDED|95.0|-0.3|0.57||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of insomnia between treatments. The alternative hypothesis was a difference in distribution of the ratings of insomnia between treatments.||0.57|-0.30|0.438
70922260|NCT04500301|141335131|OTHER|No statistical test was performed.|Proportion|0.136|||||TWO_SIDED|95.0|0.054|0.219|||||The Wald 95% confidence interval for the binomial proportion was estimated.|No hypothesis was tested with regard to the primary outcome. The study planned to enroll 80 eligible subjects such that at least 65 would be evaluable for the primary outcome and the width of the 95% Clopper-Pearson confidence interval for the proportion would be less than or equal to .25.||0.219|0.054|
71034255|NCT00318461|141578307|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.15||||0.7644||95.0|-0.55|0.25|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.25|-0.55|0.7644
71034256|NCT00318461|141578307|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.36||||0.2063||95.0|-0.86|0.14|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.14|-0.86|0.2063
71034257|NCT00318461|141578307|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.28||||0.2678||95.0|-0.68|0.12|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.12|-0.68|0.2678
70922261|NCT02058108|141335135|OTHER|Missing assessment imputed using the closest available assessment|Mean Difference (Net)|-0.3||||1|TWO_SIDED|95.0|-37.03|36.75|||Fisher Exact|||HBV DNA level of \<300 copies/mL (51 IU/mL) at Week 24|Exact confidence interval for the difference in percentage|36.75|-37.03|1.0000
70922262|NCT02058108|141335137|OTHER||Mean Difference (Net)|32.43||||0.2984|TWO_SIDED|95.0|-14.62|74.6|||Fisher Exact||Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.|ALT levels at Week 24||74.60|-14.62|0.2984
70922263|NCT02058108|141335138|OTHER||Mean Difference (Net)|2.7||||1|TWO_SIDED|95.0|-53.7|60.2|||Fisher Exact||Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.|HBeAg loss at Week 24||60.20|-53.70|1.0000
70922264|NCT02058108|141335138|OTHER||Mean Difference (Net)|2.7||||1|TWO_SIDED|95.0|-53.7|60.2|||Fisher Exact||Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.|HBeAg seroconversion at Week 24||60.20|-53.70|1.0000
71034258|NCT00318461|141578307|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.07||||0.9887||95.0|-0.57|0.43|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.43|-0.57|0.9887
71034259|NCT00318461|141578307|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.02||||0.9998||95.0|-0.38|0.42|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.42|-0.38|0.9998
71034260|NCT00318461|141578308|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.95|||<|0.0001||95.0|-2.6|-1.3|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||-1.30|-2.60|<0.0001
71034261|NCT00318461|141578308|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.11||||0.967||95.0|-0.62|0.41|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.41|-0.62|0.9670
71095873|NCT01336972|141700223|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
70976903|NCT02649634|141461448|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used||||>.05
70976904|NCT02649634|141461449|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
70976905|NCT02649634|141461450|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
71034262|NCT00318461|141578308|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.72|||<|0.0001||95.0|-2.36|-1.07|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||-1.07|-2.36|<0.0001
71034263|NCT00318461|141578308|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.13||||0.9368||95.0|-0.39|0.64|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.64|-0.39|0.9368
71034264|NCT00318461|141578308|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.06||||0.0003||95.0|-1.71|-0.42|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||-0.42|-1.71|0.0003
71034265|NCT00318461|141578308|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.78||||0.0008||95.0|0.27|1.29|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||1.29|0.27|0.0008
71034266|NCT00318461|141578309|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.66|||<|0.0001||95.0|-2.37|-0.96|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||-0.96|-2.37|<0.0001
71034267|NCT00318461|141578309|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.3||||0.5048||95.0|-0.86|0.26|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.26|-0.86|0.5048
71034268|NCT00318461|141578309|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.79|||<|0.0001||95.0|-2.49|-1.08|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||-1.08|-2.49|<0.0001
71095874|NCT03446573|141700226|NON_INFERIORITY|Non-inferiority of switching to DTG + 3TC compared to continuation of TBR (as per FDA snapshot algorithm) was to be concluded if the upper bound of a two-sided 95% confidence interval (CI) for the difference in virologic failure rates between the two treatment arms was smaller than 4%.|Adjusted difference in proportion (ADP)|-0.3|||||TWO_SIDED|95.0|-1.2|0.7|||||ADP was based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factor:Baseline third agent (protease inhibitor \[PI\], non-nucleoside reverse transcriptase inhibitor \[NNRTI\], and integrase inhibitor \[INI\]).|||0.7|-1.2|
71034269|NCT00318461|141578309|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.42||||0.2005||95.0|-0.98|0.14|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.14|-0.98|0.2005
71034270|NCT00318461|141578309|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.16||||0.0003||95.0|-1.86|-0.46|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||-0.46|-1.86|0.0003
71034271|NCT00318461|141578309|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.21||||0.7871||95.0|-0.35|0.76|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.76|-0.35|0.7871
70922265|NCT02058108|141335139|OTHER||Mean Difference (Net)|2.44||||1|TWO_SIDED|95.0|-37.54|42.17|||Fisher Exact||Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.|HBsAg loss at Week 24||42.17|-37.54|1.0000
71034272|NCT00318461|141578310|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|27.75||||0.0031||95.0|7.83|47.67|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||47.67|7.83|0.0031
71034273|NCT00318461|141578310|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|1.44||||0.9987||95.0|-15.03|17.9|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||17.90|-15.03|0.9987
71034274|NCT00318461|141578310|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|21.96||||0.0263||95.0|2.04|41.87|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||41.87|2.04|0.0263
71034275|NCT00318461|141578310|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-4.36||||0.9227||95.0|-20.94|12.22|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||12.22|-20.94|0.9227
71034276|NCT00318461|141578310|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|22.08||||0.0253||95.0|2.15|42.01|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||42.01|2.15|0.0253
71034277|NCT00318461|141578310|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-4.23||||0.9293||95.0|-20.78|12.31|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||12.31|-20.78|0.9293
71095875|NCT03446573|141700227|NON_INFERIORITY|Non-inferiority of switching to DTG + 3TC compared to continuation of TBR (as per FDA snapshot algorithm) was to be concluded when the lower bound of a 2-sided 95% confidence interval for the difference in success rates between the two treatment arms was greater than -8%.|Adjusted difference in proportion|0.2|||||TWO_SIDED|95.0|-3.4|3.9|||||ADP was based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factor: Baseline third agent (PI, NNRTI, and INSTI).|||3.9|-3.4|
71095876|NCT03446573|141700253|OTHER||Treatment ratio|1.057||||0.257|TWO_SIDED|95.0|0.96|1.164|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UA/C at Week 24 has been presented.|||1.164|0.960|0.257
71095877|NCT03446573|141700253|OTHER||Treatment ratio|1.062||||0.35|TWO_SIDED|95.0|0.936|1.205|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UA/C at Week 48 has been presented.|||1.205|0.936|0.350
71095878|NCT03446573|141700253|OTHER||Treatment ratio|0.979||||0.473|TWO_SIDED|95.0|0.924|1.037|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UP/C at Week 24 has been presented.|||1.037|0.924|0.473
71095879|NCT03446573|141700253|OTHER||Treatment ratio|0.956||||0.212|TWO_SIDED|95.0|0.891|1.026|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UP/C at Week 48 has been presented.|||1.026|0.891|0.212
71095880|NCT03446573|141700255|OTHER||Treatment ratio|0.977||||0.7|TWO_SIDED|95.0|0.866|1.102|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UA/C at Week 96 has been presented.|||1.102|0.866|0.700
71095881|NCT03446573|141700255|OTHER||Treatment ratio|0.971||||0.7|TWO_SIDED|95.0|0.835|1.129|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UA/C at Week 144 has been presented.|||1.129|0.835|0.700
71095882|NCT03446573|141700255|OTHER||Treatment ratio|0.969||||0.356|TWO_SIDED|95.0|0.907|1.036|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UP/C at Week 96 has been presented.|||1.036|0.907|0.356
71095883|NCT03446573|141700255|OTHER||Treatment ratio|0.991||||0.814|TWO_SIDED|95.0|0.916|1.071|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UP/C at Week 144 has been presented.|||1.071|0.916|0.814
71095884|NCT03446573|141700256|OTHER||Treatment ratio|0.958||||0.56|TWO_SIDED|95.0|0.83|1.106|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine beta-2 microglobulin/urine creatinine at Week 24 has been presented.|||1.106|0.830|0.560
71095885|NCT03446573|141700256|OTHER||Treatment ratio|1.055||||0.489|TWO_SIDED|95.0|0.906|1.229|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine beta-2 microglobulin/urine creatinine at Week 48 has been presented.|||1.229|0.906|0.489
70976906|NCT02649634|141461451|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
71008510|NCT02355665|141524918|SUPERIORITY||Estimated Mean Difference|-0.08||||0.517|TWO_SIDED|95.0|-0.44|0.28||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of insomnia between treatments. The alternative hypothesis was a difference in distribution of the ratings of insomnia between treatments.||0.28|-0.44|0.517
71008511|NCT02355665|141524919|SUPERIORITY||Estimated Mean Difference|-0.42||||0.027|TWO_SIDED|95.0|-0.77|-0.06||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of insomnia between treatments. The alternative hypothesis was a difference in distribution of the ratings of insomnia between treatments.||-0.06|-0.77|0.027
71008512|NCT02355665|141524920|SUPERIORITY||Estimated Mean Difference|-0.3||||0.105|TWO_SIDED|95.0|-0.93|0.33||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of increased appetite between treatments. The alternative hypothesis was a difference in distribution of the ratings of increased appetite between treatments.||0.33|-0.93|0.105
71008513|NCT02355665|141524921|SUPERIORITY||Estimated Mean Difference|-0.04||||0.604|TWO_SIDED|95.0|-0.6|0.51||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of increased appetite between treatments. The alternative hypothesis was a difference in distribution of the ratings of increased appetite between treatments.||0.51|-0.60|0.604
71008514|NCT02355665|141524922|SUPERIORITY||Estimated Mean Difference|-0.35||||0.194|TWO_SIDED|95.0|-0.93|0.24||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of increased appetite between treatments. The alternative hypothesis was a difference in distribution of the ratings of increased appetite between treatments.||0.24|-0.93|0.194
71008515|NCT02355665|141524923|SUPERIORITY||Estimated Mean Difference|-0.11||||0.502|TWO_SIDED|95.0|-0.62|0.4||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of increased appetite between treatments. The alternative hypothesis was a difference in distribution of the ratings of increased appetite between treatments.||0.40|-0.62|0.502
71008516|NCT02355665|141524924|SUPERIORITY||Estimated Mean Difference|-0.56||||0.483|TWO_SIDED|95.0|-2.84|1.73||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of aggregated withdrawal scores between treatments. The alternative hypothesis was a difference in distribution of aggregated withdrawal scores between treatments.||1.73|-2.84|0.483
71008517|NCT02355665|141524925|SUPERIORITY||Estimated Mean Difference|-1.79||||0.102|TWO_SIDED|95.0|-4.24|0.67||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of aggregated withdrawal scores between treatments. The alternative hypothesis was a difference in distribution of aggregated withdrawal scores between treatments.||0.67|-4.24|0.102
71008518|NCT02355665|141524926|SUPERIORITY||Estimated Mean Difference|-0.45||||0.532|TWO_SIDED|95.0|-2.27|1.38||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of aggregated withdrawal scores between treatments. The alternative hypothesis was a difference in distribution of aggregated withdrawal scores between treatments.||1.38|-2.27|0.532
71008519|NCT02355665|141524927|SUPERIORITY||Estimated Mean Difference|-1.01||||0.354|TWO_SIDED|95.0|-2.93|0.91||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of aggregated withdrawal scores between treatments. The alternative hypothesis was a difference in distribution of aggregated withdrawal scores between treatments.||0.91|-2.93|0.354
71008520|NCT02355665|141525096|SUPERIORITY||Least Squares Mean Difference|0.99|STANDARD_ERROR_OF_MEAN|1.679||0.558|TWO_SIDED|95.0|-2.42|4.41||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment, baseline smoking category, study site, and baseline weight were factors.|Least Squares Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in mean change from baseline in body weight between treatments. The alternative hypothesis was a difference in mean change from baseline in body weight between treatments.||4.41|-2.42|0.558
71008521|NCT02355665|141525097|SUPERIORITY||Least Squares Mean Difference|3.04|STANDARD_ERROR_OF_MEAN|3.409||0.383|TWO_SIDED|95.0|-4.03|10.11||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment, baseline smoking category, study site, and baseline weight were factors.|Least Squares Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in mean change from baseline in body weight between treatments. The alternative hypothesis was a difference in mean change from baseline in body weight between treatments.||10.11|-4.03|0.383
70976907|NCT02649634|141461452|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
71008743|NCT02055976|141525249|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-41.761|STANDARD_ERROR_OF_MEAN|14.676||0.003|TWO_SIDED|95.0|-70.934|-12.588|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-12.588|-70.934|0.003
71095886|NCT03446573|141700258|OTHER||Treatment ratio|1.165||||0.081|TWO_SIDED|95.0|0.981|1.384|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine beta-2 microglobulin/urine creatinine at Week 96 has been presented.|||1.384|0.981|0.081
71095887|NCT03446573|141700258|OTHER||Treatment ratio|0.981||||0.834|TWO_SIDED|95.0|0.819|1.175|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine beta-2 microglobulin/urine creatinine at Week 144 has been presented.|||1.175|0.819|0.834
71095888|NCT03446573|141700259|OTHER||Treatment ratio|1.017||||0.758|TWO_SIDED|95.0|0.915|1.13|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine phosphate at Week 24 has been presented.|||1.130|0.915|0.758
71095889|NCT03446573|141700259|OTHER||Treatment ratio|0.999||||0.985|TWO_SIDED|95.0|0.894|1.116|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine phosphate at Week 48 has been presented.|||1.116|0.894|0.985
71095890|NCT03446573|141700261|OTHER||Treatment ratio|1.015||||0.806|TWO_SIDED|95.0|0.904|1.139|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine phosphate at Week 96 has been presented.|||1.139|0.904|0.806
70976908|NCT02649634|141461453|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
70976909|NCT02649634|141461454|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
71095891|NCT03446573|141700261|OTHER||Treatment ratio|1.019||||0.745|TWO_SIDED|95.0|0.909|1.142|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine phosphate at Week 144 has been presented.|||1.142|0.909|0.745
71095892|NCT03446573|141700262|OTHER||Treatment ratio|0.935||||0.264|TWO_SIDED|95.0|0.83|1.052|||Mixed Model Reported Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine retinol binding protein 4/urine creatinine at Week 24 has been presented.|||1.052|0.830|0.264
71095893|NCT03446573|141700262|OTHER||Treatment ratio|0.996||||0.932|TWO_SIDED|95.0|0.903|1.098|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine retinol binding protein 4/urine creatinine at Week 48 has been presented.|||1.098|0.903|0.932
71008522|NCT02355665|141525098|SUPERIORITY||Least Squares Mean Difference|7.13|STANDARD_ERROR_OF_MEAN|4.573||0.138|TWO_SIDED|95.0|-2.56|16.83||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment, baseline smoking category, study site, and baseline weight were factors.|Least Squares Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in mean change from baseline in body weight between treatments. The alternative hypothesis was a difference in mean change from baseline in body weight between treatments.||16.83|-2.56|0.138
71008523|NCT02140762|141525113|SUPERIORITY_OR_OTHER||Vaccine Effectiveness|67.0|||<|0.0001|TWO_SIDED|95.0|65.0|69.0|||Generalized Linear Model||VE is based on the relative risk (RR). The Poisson Distribution and Log Link options were used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects: treatment group, strain (and center).|H0 (Null Hypothesis): Vaccine Effectiveness (VE) ≤10%. If the lower limit of the 95% CI for VE is \> 10% the null hypothesis is to be rejected and effectiveness declared. The VE at 1 month after the 2nd injection for each strain is defined as \[1-(% of subjects without bactericidal activity at 1:4 dilution in MenABCWY group / % of subjects without bactericidal activity at 1:4 dilution in MenACWY group)\]x100. The combined VE across all strains will be computed by mean of a generalized linear model.||69|65|<0.0001
71008524|NCT02140762|141525113|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|4.6|||||TWO_SIDED||||||Generalized Linear Model|||vaccine effectiveness\<10% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity strains in ABCWY)/(% of not killed strains/without bactericidal activity strains in ACWY)\*100\].||||
71095894|NCT03446573|141700264|OTHER||Treatment ratio|1.15||||0.011|TWO_SIDED|95.0|1.032|1.281|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine retinol binding protein 4/urine creatinine at Week 96 has been presented.|||1.281|1.032|0.011
71095895|NCT03446573|141700264|OTHER||Treatment ratio|1.007||||0.895|TWO_SIDED|95.0|0.905|1.121|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine retinol binding protein 4/urine creatinine at Week 144 has been presented.|||1.121|0.905|0.895
71095896|NCT03446573|141700272|OTHER||Mean Difference (Net)|0.29||||0.047|TWO_SIDED|95.0|0.0|0.57|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Bone-ALP at Week 24 has been presented|||0.57|0.00|0.047
71095897|NCT03446573|141700272|OTHER||Mean Difference (Net)|0.31||||0.094|TWO_SIDED|95.0|-0.05|0.68|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Bone-ALP at Week 48 has been presented|||0.68|-0.05|0.094
71095898|NCT03446573|141700272|OTHER||Mean Difference (Net)|-1.34|||<|0.001|TWO_SIDED|95.0|-2.01|-0.68|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Osteocalcin at Week 24 has been presented|||-0.68|-2.01|<0.001
71095899|NCT03446573|141700272|OTHER||Mean Difference (Net)|-1.84|||<|0.001|TWO_SIDED|95.0|-2.59|-1.09|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Osteocalcin at Week 48 has been presented|||-1.09|-2.59|<0.001
70976910|NCT02649634|141461455|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
70976911|NCT02649634|141461456|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
70976912|NCT02649634|141461457|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
70976913|NCT02649634|141461458|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
70976914|NCT02649634|141461459|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
70976915|NCT02649634|141461460|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Self-efficacy was analyzed via an independent sample t-test comparing the groups on mean global self efficacy rating on the WEL.||||>.05
70976916|NCT02649634|141461461|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Self-efficacy was analyzed via an independent sample t-test comparing the groups on mean self efficacy rating on the ESE.||||>.05
70976917|NCT02649634|141461462|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Self-efficacy was analyzed via an independent sample t-test comparing the groups on mean global self efficacy rating on the WEL.||||>.05
70976918|NCT02649634|141461463|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Self-efficacy was analyzed via an independent sample t-test comparing the groups on mean self efficacy rating on the ESE.||||>.05
71095900|NCT03446573|141700272|OTHER||Mean Difference (Net)|2.1||||0.066|TWO_SIDED|95.0|-0.1|4.3|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for P1NP at Week 24 has been presented|||4.3|-0.1|0.066
71095901|NCT03446573|141700272|OTHER||Mean Difference (Net)|2.9||||0.046|TWO_SIDED|95.0|0.0|5.8|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for P1NP at Week 48 has been presented|||5.8|0.0|0.046
71095902|NCT03446573|141700272|OTHER||Mean Difference (Net)|0.0381||||0.005|TWO_SIDED|95.0|0.0117|0.0646|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for CTX-1 at Week 24 has been presented|||0.0646|0.0117|0.005
70976919|NCT02649634|141461464|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Importance of Change ratings were analyzed via an independent sample t-test comparing the groups on mean Importance of Change ratings on the 11-point visual analogue scales||||>.05
70976920|NCT02649634|141461465|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Readiness for Change ratings were analyzed via an independent sample t-test comparing the groups on mean Readiness for Change ratings on the 11-point visual analogue scales||||>.05
70976921|NCT02649634|141461466|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Confidence for Change ratings were analyzed via an independent sample t-test comparing the groups on mean Confidence for Change ratings on the 11-point visual analogue scales||||>.05
70976922|NCT02649634|141461467|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Importance of Change ratings were analyzed via an independent sample t-test comparing the groups on mean Importance of Change ratings on the 11-point visual analogue scales||||>.05
70976923|NCT02649634|141461468|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Readiness for Change ratings were analyzed via an independent sample t-test comparing the groups on mean Readiness for Change ratings on the 11-point visual analogue scales||||>.05
71095903|NCT03446573|141700272|OTHER||Mean Difference (Net)|0.0292||||0.032|TWO_SIDED|95.0|0.0025|0.0559|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for CTX-1 at Week 48 has been presented|||0.0559|0.0025|0.032
71095904|NCT03446573|141700274|OTHER||Mean Difference (Net)|0.17||||0.386|TWO_SIDED|95.0|-0.22|0.57|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Bone-ALP at Week 96 has been presented|||0.57|-0.22|0.386
71095905|NCT03446573|141700274|OTHER||Mean Difference (Net)|0.14||||0.573|TWO_SIDED|95.0|-0.34|0.61|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Bone-ALP at Week 144 has been presented|||0.61|-0.34|0.573
70976924|NCT02649634|141461469|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Confidence for Change ratings were analyzed via an independent sample t-test comparing the groups on mean Confidence for Change ratings on the 11-point visual analogue scales||||>.05
70976925|NCT02211261|141461502|OTHER||Percentage of Test relative to Reference|17.66|||||TWO_SIDED|90.0|8.44|36.95|||||PF-06293620 0.3 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||36.95|8.44|
70976926|NCT02211261|141461502|OTHER||Percentage of Test relative to Reference|32.73|||||TWO_SIDED|90.0|21.64|49.51|||||PF-06293620 1.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||49.51|21.64|
71095906|NCT03446573|141700274|OTHER||Mean Difference (Net)|-1.87|||<|0.001|TWO_SIDED|95.0|-2.7|-1.04|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Osteocalcin at Week 96 has been presented|||-1.04|-2.70|< 0.001
71095907|NCT03446573|141700274|OTHER||Mean Difference (Net)|-1.95|||<|0.001|TWO_SIDED|95.0|-2.77|-1.14|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Osteocalcin at Week 144 has been presented|||-1.14|-2.77|< 0.001
71095908|NCT03446573|141700274|OTHER||Mean Difference (Net)|2.1||||0.082|TWO_SIDED|95.0|-0.3|4.4|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for P1NP at Week 96 has been presented.|||4.4|-0.3|0.082
71095909|NCT03446573|141700274|OTHER||Mean Difference (Net)|0.4||||0.765|TWO_SIDED|95.0|-2.3|3.2|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for P1NP at Week 144 has been presented|||3.2|-2.3|0.765
70976927|NCT02211261|141461502|OTHER||Percentage of Test relative to Reference|35.02|||||TWO_SIDED|90.0|23.6|51.95|||||PF-06293620 3.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||51.95|23.60|
70976928|NCT02211261|141461502|OTHER||Percentage of Test relative to Reference|53.18|||||TWO_SIDED|90.0|36.36|77.78|||||PF-06293620 6.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||77.78|36.36|
70976929|NCT02211261|141461504|OTHER||Percentage of Test relative to Reference|7.32|||||TWO_SIDED|90.0|4.7|11.4|||||PF-06293620 0.3 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||11.40|4.70|
70976930|NCT02211261|141461504|OTHER||Percentage of Test relative to Reference|32.19|||||TWO_SIDED|90.0|20.67|50.12|||||PF-06293620 1.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||50.12|20.67|
70976931|NCT02211261|141461504|OTHER||Percentage of Test relative to Reference|34.43|||||TWO_SIDED|90.0|22.57|52.52|||||PF-06293620 3.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||52.52|22.57|
71034278|NCT00318461|141578311|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|25.71||||0.8821||95.0|-69.84|121.26|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||121.26|-69.84|0.8821
71095910|NCT03446573|141700274|OTHER||Mean Difference (Net)|0.0151||||0.301|TWO_SIDED|95.0|-0.0136|0.0438|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for CTX-1 at Week 96 has been presented|||0.0438|-0.0136|0.301
71095911|NCT03446573|141700274|OTHER||Mean Difference (Net)|0.0126||||0.34|TWO_SIDED|95.0|-0.0133|0.0384|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for CTX-1 at Week 144 has been presented|||0.0384|-0.0133|0.340
70976932|NCT02211261|141461504|OTHER||Percentage of Test relative to Reference|51.47|||||TWO_SIDED|90.0|34.26|77.31|||||PF-06293620 6.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||77.31|34.26|
70976933|NCT03183128|141461539|SUPERIORITY||Risk Ratio (RR)|0.32|||<|0.001|TWO_SIDED|95.0|0.18|0.58||P-value presented for both hypothesis tests: H0: RR≥1 and H0: RR≥0.833.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by age (\<65 years, ≥65 years) and prior antibiotic regimen (vancomycin, fidaxomicin).|RR defined as the recurrence rates of SER-109 divided by Placebo. Cochran-Mantel-Haenszel estimate of RR, stratified by age group (\<65 years, ≥65 years) and prior antibiotic regimen for the qualifying episode (vancomycin, fidaxomicin), is reported.|||0.58|0.18|<0.001
70976934|NCT03183128|141461540|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.001|TWO_SIDED|95.0|0.19|0.67||P-value presented is for the hypothesis test: H0: RR ≥1.0.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel estimate is stratified by age (\<65 years, ≥65 years) and prior antibiotic regimen (vancomycin, fidaxomicin).|RR defined as the recurrence rates of SER-109 divided by Placebo. Cochran-Mantel-Haenszel estimate of RR, stratified by age group (\<65 years, ≥65 years) and prior antibiotic regimen for the qualifying episode (vancomycin, fidaxomicin), is reported.|CDI recurrence rates at Week 4||0.67|0.19|<0.001
70976935|NCT03183128|141461540|SUPERIORITY||Hazard Ratio (HR)|0.4|||<|0.001|TWO_SIDED|95.0|0.24|0.65||P-value presented is for the hypothesis test: H0: RR ≥1.0.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel estimate is stratified by age (\<65 years, ≥65 years) and prior antibiotic regimen (vancomycin, fidaxomicin).|RR defined as the recurrence rates of SER-109 divided by Placebo. Cochran-Mantel-Haenszel estimate of RR, stratified by age group (\<65 years, ≥65 years) and prior antibiotic regimen for the qualifying episode (vancomycin, fidaxomicin), is reported.|CDI recurrence rates at Week 12||0.65|0.24|<0.001
70976936|NCT03183128|141461540|SUPERIORITY||Hazard Ratio (HR)|0.46|||<|0.001|TWO_SIDED|95.0|0.3|0.73||P-value presented is for the hypothesis test: H0: RR ≥1.0.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel estimate is stratified by age (\<65 years, ≥65 years) and prior antibiotic regimen (vancomycin, fidaxomicin).|RR defined as the recurrence rates of SER-109 divided by Placebo. Cochran-Mantel-Haenszel estimate of RR, stratified by age group (\<65 years, ≥65 years) and prior antibiotic regimen for the qualifying episode (vancomycin, fidaxomicin), is reported.|CDI recurrence rates at Week 24||0.73|0.30|<0.001
70976937|NCT00330187|141461551|SUPERIORITY||Odds Ratio (OR)|3.6||||0.07|TWO_SIDED|95.0|0.9|14.4|||Regression, Logistic|||||14.4|0.9|0.07
70976938|NCT00754156|141461595|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis|||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
70976939|NCT01751971|141461610|SUPERIORITY||Mean Difference (Net)|10.5||||0.4|TWO_SIDED|95.0|-16.0|37.1|||t-test, 2 sided||Positive estimated value would represent a greater reduction in AHI with oxygen (% sham) in the high vs low loop gain group.|"Primary statistical comparison was the percent reduction in AHI----\[AHI(sham)-AHI(oxygen)\]/AHI(sham) %----between two phenotypic patient subgroups. Patient subgroups were defined by the loop gain (LG1) measured on the sham night as high or low (a priori cutoff LG1=0.7)."||37.1|-16|0.4
70976940|NCT01751971|141461610|SUPERIORITY||Mean Difference (Final Values)|17.4|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|10.7|24.1|||t-test, 2 sided||Direction of comparison: Positive estimation parameter would indicate lower AHI on oxygen versus sham.|Here we aimed to confirm that there was a difference between AHI on oxygen vs sham (overall, i.e. in unselected patients). This test, however was not part of our primary objective.||24.1|10.7|<0.001
70976941|NCT01751971|141461610|SUPERIORITY||Mean Difference (Net)|42.8||||0.001|TWO_SIDED|95.0|21.0|64.6|||t-test, 2 sided||Direction of comparison: Positive estimated value would indicate a greater percentage reduction in AHI (oxygen vs. sham) in favorable vs. unfavorable subgroups.|"The primary goal of the study was to identify a phenotypic subgroup of patients with sleep apnea that responds preferentially to oxygen (percent reduction in AHI----\[AHI(sham)-AHI(oxygen)\]/AHI(sham) %). We defined patient subgroups (favorable versus unfavorable) based on the four key phenotypic traits (loop gain, collapsibility, arousal threshold, muscle responses) measured on the sham night, with the use of multiple logistic regression and leave-one-out cross validation."||64.6|21.0|0.001
70976942|NCT00364182|141461616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.5|||<|0.0001|TWO_SIDED|95.0|-36.5|-24.5||P-values based on a model including terms for treatment regimen, treatment sequence, and the interaction of these terms with repeated measures on participants.|ANOVA|||||-24.5|-36.5|<0.0001
70976943|NCT00364182|141461616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.5|||<|0.0001|TWO_SIDED|95.0|-38.5|-26.6||P-values based on a model including terms for treatment regimen, treatment sequence, and the interaction of these terms with repeated measures on participants.|ANOVA|||||-26.6|-38.5|<0.0001
70976944|NCT00364182|141461616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.2167|TWO_SIDED|95.0|-1.2|5.2||P-values based on a model including terms for treatment regimen, treatment sequence, and the interaction of these terms with repeated measures on participants.|ANOVA|||||5.2|-1.2|0.2167
70976945|NCT00364182|141461617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.002|TWO_SIDED|95.0|0.1|0.6|||ANOVA|||Mean difference in duration of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||0.6|0.1|0.002
70976946|NCT00364182|141461617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.021|TWO_SIDED|95.0|0.1|0.8|||ANOVA|||Mean difference in duration of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||0.8|0.1|0.021
70976947|NCT00364182|141461617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.004|TWO_SIDED|95.0|0.2|0.9|||ANOVA|||Mean difference in duration of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||0.9|0.2|0.004
70976948|NCT00364182|141461617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.093|TWO_SIDED|95.0|-0.1|0.8|||ANOVA|||Mean difference in duration of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||0.8|-0.1|0.093
70976949|NCT00364182|141461618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0|TWO_SIDED|95.0|-0.4|-0.1|||ANOVA|||Mean difference in quality of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||-0.1|-0.4|0.000
70976950|NCT00364182|141461618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0|TWO_SIDED|95.0|-0.5|-0.2|||ANOVA|||Mean difference in quality of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||-0.2|-0.5|0.0000
70976951|NCT00364182|141461618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.002|TWO_SIDED|95.0|-0.5|-0.1|||ANOVA|||Mean difference in quality of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||-0.1|-0.5|0.002
70976952|NCT00364182|141461618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.031|TWO_SIDED|95.0|-0.5|0.0|||ANOVA|||Mean difference in quality of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||-0.0|-0.5|0.031
71034279|NCT00318461|141578311|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|6.56||||0.9989||95.0|-72.66|85.79|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||85.79|-72.66|0.9989
70976953|NCT00364182|141461622|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.1||||0.544|TWO_SIDED|95.0|-9.2|4.9|||ANOVA|||||4.9|-9.2|0.544
70976954|NCT00364182|141461622|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.592|TWO_SIDED|95.0|-7.5|4.3|||ANOVA|||||4.3|-7.5|0.592
71034280|NCT00318461|141578311|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|35.2||||0.7292||95.0|-60.33|130.72|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||130.72|-60.33|0.7292
70976955|NCT00364182|141461622|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.6||||0.131|TWO_SIDED|95.0|-1.1|8.4|||ANOVA|||||8.4|-1.1|0.131
70976956|NCT01261559|141461625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.2|STANDARD_DEVIATION|10.0||0.003|TWO_SIDED|95.0|4.0|25.0|||Regression, Linear|A multivariate linear regression model was fitted for the main outcome of percent relative dose, with age, BMI, and bra cup size as covariates.||Powered to detect difference of 10% at 80% power if 66 or more subjects enrolled.||25|4|0.003
70976957|NCT02921425|141461632|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||.003
70976958|NCT02921425|141461634|OTHER|||||||0.007|||||||t-test, 2 sided|||||||.007
70976959|NCT02921425|141461635|OTHER|||||||0.026|||||||t-test, 2 sided|||||||.026
70976960|NCT02921425|141461637|OTHER|||||||0.003||||||systolic blood pressure|t-test, 2 sided|||||||.003
70976961|NCT02921425|141461637|OTHER|||||||0.001|||||||t-test, 2 sided|||diastolic blood pressure||||.001
70976962|NCT02921425|141461639|OTHER|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||||||.019
70976963|NCT03403400|141461643|EQUIVALENCE|Comparison of variance|Test Statistics|0.893||||0.64|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference between groups in mCTSIB Ha: There is a significant difference between groups in mCTSIB||||.640
70976964|NCT03403400|141461643|EQUIVALENCE|Comparison of variance|Test Statistics|0.196||||0.18|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference between the prescribed walking group and the control group in mCTSIB Ha: There is a significant difference between the prescribed walking group and the control group in mCTSIB||||.18
70976965|NCT03403400|141461644|EQUIVALENCE|comparison of variance|Test Statistics|0.803||||0.67|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference between the groups in TUG Ha: There is a significant difference between the groups in TUG||||.67
70976966|NCT03403400|141461644|EQUIVALENCE|comparison of variance|Test Statistics|0.14||||0.71|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference in TUG between the prescribed walking and control group Ha: There is a significant difference in TUG between the prescribed walking and control group||||.71
70976967|NCT03403400|141461645|EQUIVALENCE|Comparison of variance|Test Statistics|0.803|STANDARD_DEVIATION|1.79||0.67|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference between the groups in DGI Ha: There is a significant difference between the groups in DGI||||.67
70976968|NCT03403400|141461645|EQUIVALENCE|comparison of variance|Test Statistics|0.66||||0.42|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference between the prescribed walking group and the control group in DGI Ha: There is a significant difference between the prescribed walking group and control group in DGI||||.42
70976969|NCT03403400|141461646|EQUIVALENCE|comparison of variance|Test Statistics|4.386||||0.11|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference between the groups in DHI Ha: There is a significant difference between the groups in DHI||||.11
71095912|NCT03446573|141700275|OTHER||Mean Difference (Net)|-2.2||||0.173|TWO_SIDED|95.0|-5.3|1.0|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum 25 hydroxyvitamin D at Week 24 has been presented|||1.0|-5.3|0.173
70976970|NCT03403400|141461646|EQUIVALENCE|comparison of variance|Test Statistics|4.351||||0.04|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference in DHI between the prescribed walking group and the control group Ha: There is a significant difference in DHI between the prescribed walking group and the control group||||.04
70976971|NCT01171612|141461664|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.086||||0.479|TWO_SIDED|95.0|0.513|2.299|||Chi-squared|||Reference group were patients who maintained antiplatelet drugs (aspirin and/or clopidogrel) during the 4 days before surgery||2.299|0.513|0.479
70976972|NCT01171612|141461664|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.638||||0.479|TWO_SIDED|95.0|0.733|3.662|||Chi-squared|||||3.662|0.733|0.479
70976973|NCT04666038|141461695|SUPERIORITY||Hazard Ratio (HR)|0.536||||0.0002|TWO_SIDED|95.0|0.385|0.746||The 2-sided nominal p-value was calculated based on a stratified log-rank test.|Log Rank||The Hazard Ratio (HR) \& 95% confidence interval (CI) were estimated from a stratified Cox proportional hazards model.|||0.746|0.385|0.0002
70976974|NCT04666038|141461696|SUPERIORITY||Hazard Ratio (HR)|0.475|||<|0.0001|TWO_SIDED|95.0|0.338|0.669||The 2-sided nominal p-value was calculated based on a stratified log-rank test|Log Rank||The HR and 95% CI were estimated from a stratified Cox proportional hazards model.|||0.669|0.338|<0.0001
70976975|NCT04666038|141461697|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.7202|TWO_SIDED|95.0|0.679|1.749||The 2-sided p-value was calculated based on a stratified log-rank test.|Log Rank||The HR and 95% CI were estimated from a stratified Cox proportional hazards model.|||1.749|0.679|0.7202
70976976|NCT04666038|141461698|SUPERIORITY||Hazard Ratio (HR)|0.365|||<|0.0001|TWO_SIDED|95.0|0.254|0.524||The 2-sided nominal p-value was calculated based on a stratified log-rank test.|Log Rank||The HR and 95% CI were estimated from a stratified Cox proportional hazards model.|||0.524|0.254|<0.0001
70976977|NCT04666038|141461699|SUPERIORITY||Hazard Ratio (HR)|0.387|||<|0.0001|TWO_SIDED|95.0|0.28|0.534||The 2-sided nominal p-value was calculated based on a stratified log-rank test.|Log Rank||The HR and 95% CI were estimated from a stratified Cox proportional hazards model.|||0.534|0.280|<0.0001
71034281|NCT00318461|141578311|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|16.05||||0.9689||95.0|-63.69|95.79|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||95.79|-63.69|0.9689
71095913|NCT03446573|141700275|OTHER||Mean Difference (Net)|-2.3||||0.168|TWO_SIDED|95.0|-5.5|1.0|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum 25 hydroxyvitamin D at Week 48 has been presented|||1.0|-5.5|0.168
70976978|NCT03400800|141461703|SUPERIORITY||Mean Difference (Final Values)|-53.5|||<|0.0001|TWO_SIDED|95.0|-56.66|-50.35||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-50.35|-56.66|<0.0001
70976979|NCT03400800|141461704|SUPERIORITY||Mean Difference (Final Values)|-49.17|||<|0.0001|TWO_SIDED|95.0|-51.57|-46.77||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-46.77|-51.57|<0.0001
70976980|NCT03400800|141461705|SUPERIORITY||Median Difference (Final Values)|-51.87|||<|0.0001|TWO_SIDED|95.0|-55.01|-48.72||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-48.72|-55.01|<.0001
70976981|NCT03400800|141461706|SUPERIORITY||Mean Difference (Final Values)|-48.94|||<|0.0001|TWO_SIDED|95.0|-51.39|-46.48||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-46.48|-51.39|<0.0001
70976982|NCT03400800|141461707|SUPERIORITY||Mean Difference (Final Values)|-79.27|||<|0.0001|TWO_SIDED|95.0|-81.97|-76.57||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-76.57|-81.97|<0.0001
70976983|NCT03400800|141461708|SUPERIORITY||Mean Difference (Final Values)|-29.79|||<|0.0001|TWO_SIDED|95.0|-31.78|-27.81||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-27.81|-31.78|<0.0001
70976984|NCT03400800|141461709|SUPERIORITY||Mean Difference (Final Values)|-38.94|||<|0.0001|TWO_SIDED|95.0|-41.21|-36.67||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-36.67|-41.21|<0.0001
70976985|NCT03400800|141461710|SUPERIORITY||Mean Difference (Final Values)|-43.32|||<|0.0001|TWO_SIDED|95.0|-46.04|-40.6||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-40.60|-46.04|<0.0001
70976986|NCT01412957|141461738|SUPERIORITY_OR_OTHER||Normal score|-2.59||||0.0096|||||||Log Rank|Log-rank test stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|A normal score \< 0 indicates fewer than expected events for the panitumumab plus BSC arm and therefore a longer time to event.|The primary hypothesis was that panitumumab plus BSC would improve overall survival compared to BSC alone. A comparison between treatments was performed using the log-rank test stratified by the randomization factors at a 5% significance level.||||0.0096
70976987|NCT01412957|141461739|SUPERIORITY_OR_OTHER||Normal score|-6.08|||<|0.0001|||||||Log Rank|Log-rank test stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|A normal score \< 0 indicates fewer than expected events for the panitumumab plus BSC arm and therefore a longer time to event.|PFS in the ITT Analysis Set was tested at a significance level of 5% conditional on a significant treatment effect on overall survival in the ITT Analysis Set.||||<0.0001
70976988|NCT01412957|141461740|SUPERIORITY_OR_OTHER||Normal score|-2.47||||0.0135|||||||Log Rank|Log-rank test stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|A normal score \< 0 indicates fewer than expected events for the panitumumab plus BSC arm and therefore a longer time to event.|Overall survival in the Wild-type RAS Efficacy Analysis Set was compared at a significance level of 5% conditional on a significant treatment effect for progression-free survival in the ITT Analysis Set.||||0.0135
70976989|NCT01412957|141461741|SUPERIORITY_OR_OTHER||Normal score|-5.98|||<|0.0001|||||||Log Rank|Log-rank test stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|A normal score \< 0 indicates fewer than expected events for the panitumumab plus BSC arm and therefore a longer time to event.|PFS in the Wild-type RAS Efficacy Analysis Set was to be compared at a significance level of 5% if overall survival in the wild-type RAS Efficacy Anaysis Set demonstrated a significant treatment effect.||||<0.0001
70976990|NCT01412957|141461742|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.89|||<|0.0001|TWO_SIDED|95.0|7.47|123.77|||Stratified exact test|Stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|The odds ratio is defined as the odds of having an objective response in the panitumumab plus BSC arm relative to the odds in BSC alone arm.|ORR was not formally tested and the p-values are descriptive only. An exact test was used to test the hypothesis that the common odds ratio for panitumumab plus BSC relative to BSC alone for the objective response is equal to 1.0 stratified by the randomization factors.||123.77|7.47|<0.0001
70976991|NCT01412957|141461743|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.0|||<|0.0001|TWO_SIDED|95.0|5.89|101.62|||Stratified exact test|Stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|The odds ratio is defined as the odds of having an objective response in the panitumumab plus BSC arm relative to the odds in BSC alone arm.|ORR was not formally tested and the p-values are descriptive only. An exact test was used to test the hypothesis that the common odds ratio for panitumumab plus BSC relative to BSC alone for the objective response is equal to 1.0 stratified by the randomization factors.||101.62|5.89|<0.0001
70976992|NCT04722991|141461746|OTHER|Bayesian inference with non-informative priors|Point estimate|-0.015|||||TWO_SIDED|95.0|-0.08|0.029|||||Median of posterior distribution|||0.029|-0.080|
70976993|NCT02246621|141461754|SUPERIORITY||Hazard Ratio (HR)|0.54||||2e-06|TWO_SIDED|95.0|0.418|0.698|||Log Rank|||||0.698|0.418|0.000002
70976994|NCT02246621|141461756|SUPERIORITY|||||||0.005|||||||Cochran-Mantel-Haenszel|||||||0.005
70976995|NCT02246621|141461758|SUPERIORITY|||||||0.501|||||||Cochran-Mantel-Haenszel|||||||0.501
70976996|NCT02246621|141461759|SUPERIORITY|||||||0.101|||||||Cochran-Mantel-Haenszel|||||||0.101
70976997|NCT02246621|141461763|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.688|TWO_SIDED||||||Mixed Models Analysis|||||||0.688
71034282|NCT00318461|141578311|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|72.38||||0.1818||95.0|-23.15|167.9|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||167.90|-23.15|0.1818
71034283|NCT00318461|141578311|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|53.23||||0.2978||95.0|-26.3|132.76|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||132.76|-26.30|0.2978
71034284|NCT04134091|141578314|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70976998|NCT02246621|141461764|SUPERIORITY||Mean Difference (Net)|-1.01|STANDARD_ERROR_OF_MEAN|1.39||0.466|TWO_SIDED||||||Mixed Models Analysis|||||||0.466
70976999|NCT01583374|141461767|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-4.1||||0.4383|TWO_SIDED|95.0|-14.3|6.2|||Cochran-Mantel-Haenszel|2 sided p-value was based on CMH test adjusting for C-reactive protein (CRP) category and baseline BASDAI score category|Adjusted difference is the weighted average of the treatment differences across the 4 strata of screening CRP category and baseline BASDAI score category with the Cochran-Mantel-Haenszel (CMH) weights|||6.2|-14.3|0.4383
70977000|NCT01583374|141461767|SUPERIORITY||Risk Difference (RD)|-1.7||||0.7427|TWO_SIDED|95.0|-12.0|8.5|||Cochran-Mantel-Haenszel|2 sided p-value was based on CMH test adjusting for C-reactive protein (CRP) category and baseline BASDAI score category|Adjusted difference in proportions is the weighted average of the treatment differences across the 4 strata of screening CRP category and baseline BASDAI score category with the Cochran-Mantel-Haenszel weights.|||8.5|-12.0|0.7427
70977001|NCT01583374|141461768|SUPERIORITY||LS Mean Difference|-0.05||||0.8032|TWO_SIDED|95.0|-0.41|0.32|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.32|-0.41|0.8032
70977002|NCT01583374|141461768|SUPERIORITY||LS Mean Difference|-0.17||||0.3624|TWO_SIDED|95.0|-0.53|0.19|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.19|-0.53|0.3624
71034285|NCT04134091|141578314|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71034286|NCT04134091|141578315|SUPERIORITY|||||||0.0001|||||||ANCOVA|||||||0.0001
70977003|NCT01583374|141461769|SUPERIORITY||LS Mean Difference|0.03||||0.8618|TWO_SIDED|95.0|-0.33|0.4|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.40|-0.33|0.8618
71034287|NCT04134091|141578315|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71034288|NCT04134091|141578316|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
71034289|NCT04134091|141578316|SUPERIORITY||||||<|0.01|||||||Fisher Exact|||||||<0.01
71034290|NCT04134091|141578317|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
70977004|NCT01583374|141461769|SUPERIORITY||LS Mean Difference|-0.09||||0.6262|TWO_SIDED|95.0|-0.45|0.27|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.27|-0.45|0.6262
70977005|NCT01583374|141461770|SUPERIORITY||Risk Difference (RD)|2.0||||0.6958|TWO_SIDED|95.0|-8.1|12.2|||Cochran-Mantel-Haenszel|2 sided p-value was based on the CMH test adjusting for C-reactive protein (CRP) category and baseline BASDAI score category.|Adjusted difference is the weighted average of the treatment differences across the 4 strata of screening CRP category and baseline BASDAI score category with the Cochran-Mantel-Haenszel weights.|||12.2|-8.1|0.6958
70977006|NCT01583374|141461770|SUPERIORITY||Risk Difference (RD)|4.4||||0.4051|TWO_SIDED|95.0|-5.8|14.5|||Cochran-Mantel-Haenszel|2 sided p-value was based on the CMH test adjusting for C-reactive protein (CRP) category and baseline BASDAI score category.|Adjusted difference is the weighted average of the treatment differences across the 4 strata of screening CRP category and baseline BASDAI score category with the Cochran-Mantel-Haenszel weights.|||14.5|-5.8|0.4051
70977007|NCT01583374|141461771|SUPERIORITY||LS Mean Difference|0.25||||0.5126|TWO_SIDED|95.0|-0.49|0.99|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.99|-0.49|0.5126
70977008|NCT01583374|141461771|SUPERIORITY||LS Mean Difference|0.28||||0.4624|TWO_SIDED|95.0|-0.46|1.01|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||1.01|-0.46|0.4624
70977009|NCT01583374|141461772|SUPERIORITY||LS Mean Difference|0.29||||0.6997|TWO_SIDED|95.0|-1.18|1.76|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||1.76|-1.18|0.6997
70977010|NCT01583374|141461772|SUPERIORITY||LS Mean Difference|-0.04||||0.9587|TWO_SIDED|95.0|-1.5|1.42|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||1.42|-1.50|0.9587
70977011|NCT01583374|141461773|SUPERIORITY||LS Mean Difference|0.06||||0.3307|TWO_SIDED|95.0|-0.06|0.17|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.17|-0.06|0.3307
70977012|NCT01583374|141461773|SUPERIORITY||LS Mean Difference|0.03||||0.5938|TWO_SIDED|95.0|-0.08|0.14|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.14|-0.08|0.5938
70977013|NCT01265524|141461778|NON_INFERIORITY_OR_EQUIVALENCE|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.||||||0.014|TWO_SIDED|95.0||||Corrections for multiplicity were not performed and P values \< 0.05 were considered statistically significant.|ANCOVA|Continuous or ordinal data were analyzed using RM-ANCOVA using change from baseline values to compare CLP and placebo treatments.||||||0.014
70977014|NCT01265524|141461782|NON_INFERIORITY_OR_EQUIVALENCE|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.||||||0.0002|TWO_SIDED|95.0||||Corrections for multiplicity were not performed and P values \< 0.05 were considered statistically significant.|ANCOVA|Continuous or ordinal data were analyzed using RM-ANCOVA using change from baseline values to compare CLP and placebo treatments.||||||0.0002
70977015|NCT01265524|141461783|NON_INFERIORITY_OR_EQUIVALENCE|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.||||||0.072|TWO_SIDED|95.0||||Corrections for multiplicity were not performed and P values \< 0.05 were considered statistically significant.|ANCOVA|Continuous or ordinal data were analyzed using RM-ANCOVA using change from baseline values to compare CLP and placebo treatments.||||||0.072
70977016|NCT02591615|141461802|SUPERIORITY|||||||0.2176|||||||Fisher Exact|||||||0.2176
70977017|NCT02591615|141461803|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.84|TWO_SIDED|95.0|0.67|1.64|||Log Rank|||||1.64|0.67|0.84
70977018|NCT02107703|141461811|OTHER||Hazard Ratio (HR)|0.553|||<|1e-07|TWO_SIDED|95.0|0.449|0.681||This is two sided P value and it is statistically significant.|Log Rank|Log rank test is stratified by endocrine sensitivity and natural of disease by interactive web response system (IWRS).||The final analysis was planned at 378 PFS events, which would provide approximately 90% power assuming a hazard ratio (HR) of 0.703 at a one-sided α of 0.025.||0.681|0.449|<0.0000001
70977019|NCT04574999|141461822|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70977020|NCT04574999|141461823|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70977021|NCT04574999|141461825|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70977022|NCT04574999|141461826|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70977023|NCT00008385|141461832|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.25||||0.294|TWO_SIDED|95.0|0.64|2.37||This p value should be compared to the nominal p value of 0.0035 adjusting for the previous interim analyses|Log Rank||The 95% confidence interval was repeated confidence interval for the risk ratio|||2.37|0.64|0.294
70977024|NCT00008385|141461833|SUPERIORITY_OR_OTHER_LEGACY|||||||0.069|TWO_SIDED||||||Log Rank|||||||0.069
70977025|NCT00008385|141461834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.154|TWO_SIDED||||||Log Rank|||||||0.154
70977026|NCT00066690|141461859|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.1|TWO_SIDED|95.0|0.66|1.04|||Log Rank||Tamoxifen was the reference group in the estimation of the hazard ratio.|||1.04|0.66|0.1
70977027|NCT00066690|141461859|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.53|0.86|||||Tamoxifen was the reference group in the estimation of the hazard ratio.|||0.86|0.53|
70977028|NCT00066690|141461860|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.09|TWO_SIDED|95.0|0.3|1.03|||Log Rank||Tamoxifen was the reference group in the estimation of the hazard ratio.|||1.03|0.3|0.09
70977029|NCT00066690|141461860|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.49|0.83|||||Tamoxifen was the reference group in the estimation of the hazard ratio.|||0.83|0.49|
70977030|NCT00066690|141461861|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.4|TWO_SIDED|95.0|0.66|1.18|||Log Rank||T was the reference group in the estimation of the hazard ratio.|||1.18|0.66|0.40
70977031|NCT00066690|141461861|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.52|0.96|||||T was the reference group in the estimation of hazard ratio.|||0.96|0.52|
70977032|NCT00066690|141461862|SUPERIORITY|\[not specified\]|Hazard Ratio (HR)|0.67||||0.01|TWO_SIDED|95.0|0.48|0.92|||Log Rank||T was the reference group in the estimation of the hazard ratio|||0.92|0.48|0.01
70977033|NCT00066690|141461862|SUPERIORITY|\[not specified\]|Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.62|1.15|||||T was the reference group in the estimation of hazard ratio|||1.15|0.62|
70977034|NCT05256888|141461864|SUPERIORITY||Slope|-1.77|STANDARD_ERROR_OF_MEAN|1.08||0.11|TWO_SIDED||||||Regression, Linear|||"In a linear model to assess group effects on fatigue at 12 weeks, adjusting for baseline levels of fatigue:~Effect of group = -1.77±1.08, p=0.11, favoring the TRE group."||||0.11
70977035|NCT03706365|141461868|OTHER||Hazard Ratio (HR)|0.829||||0.2123|TWO_SIDED|95.0|0.619|1.111|||Log Rank|||||1.111|0.619|0.2123
70977036|NCT03706365|141461869|OTHER||Hazard Ratio (HR)|0.637||||0.0026|TWO_SIDED|95.0|0.474|0.856|||Log Rank|||||0.856|0.474|0.0026
70977037|NCT03706365|141461870|OTHER||Hazard Ratio (HR)|0.842||||0.2899|TWO_SIDED|95.0|0.611|1.16|||Log Rank|||||1.160|0.611|0.2899
70977038|NCT03706365|141461872|OTHER||Hazard Ratio (HR)|0.731||||0.3531|TWO_SIDED|95.0|0.377|1.419|||Log Rank|||||1.419|0.377|0.3531
70977039|NCT03706365|141461873|OTHER||Hazard Ratio (HR)|0.927||||0.6507|TWO_SIDED|95.0|0.669|1.285|||Log Rank|||||1.285|0.669|0.6507
70977040|NCT03706365|141461874|OTHER||Hazard Ratio (HR)|0.768||||0.1807|TWO_SIDED|95.0|0.522|1.131|||Log Rank|||||1.131|0.522|0.1807
70977041|NCT03706365|141461879|OTHER||Hazard Ratio (HR)|0.935||||0.697|TWO_SIDED|95.0|0.665|1.314|||Log Rank|||||1.314|0.665|0.6970
70977042|NCT02162862|141461880|OTHER||||||<|0.005|||||||t-test, 2 sided|||||||<0.005
70977043|NCT02162862|141461880|OTHER||||||<|0.005|||||||t-test, 2 sided|||||||<0.005
70977044|NCT02162862|141461880|OTHER|||||||0.102|||||||t-test, 2 sided|||||||.102
70977045|NCT02162862|141461881|OTHER||||||<|0.005|||||||t-test, 2 sided|||||||<0.005
70977046|NCT02162862|141461881|OTHER|||||||0.646|||||||t-test, 2 sided|||||||.646
70977047|NCT02162862|141461881|OTHER||||||<|0.005|||||||t-test, 2 sided|||||||<0.005
70977048|NCT03116113|141461884|SUPERIORITY||||||=|0.3181|||||||Fisher's Exact-Boschloo test|||||||=0.3181
70977049|NCT03116113|141461884|SUPERIORITY||||||=|0.5177|||||||Fisher's Exact-Boschloo test|||||||=0.5177
70977050|NCT05195528|141461941|SUPERIORITY||Difference in least square mean|17.1|||<|0.0001|TWO_SIDED|95.0|11.81|22.45||P-values were obtained from the general linear model with treatment group as factor and severity and frequency of heartburn at baseline as covariates.|General linear model|||||22.45|11.81|<0.0001
70977051|NCT05195528|141461941|SUPERIORITY||Least square mean difference|16.7|||<|0.0001|TWO_SIDED|95.0|11.36|22.04||P-values were obtained from the general linear model with treatment group as factor and severity and frequency of heartburn at baseline as covariates.|General linear model|||||22.04|11.36|<0.0001
70977052|NCT05195528|141461942|SUPERIORITY||Least square mean difference|15.8|||<|0.0001|TWO_SIDED|95.0|9.93|21.6||P-values were obtained from the general linear model with treatment group as factor and severity and frequency of heartburn at baseline as covariates.|General linear model|||||21.60|9.93|<0.0001
70977053|NCT05195528|141461942|SUPERIORITY||Least square mean difference|13.7|||<|0.0001|TWO_SIDED|95.0|7.84|19.54||P-values were obtained from the general linear model with treatment group as factor and severity and frequency of heartburn at baseline as covariates.|General linear model|||||19.54|7.84|<0.0001
70977054|NCT01552902|141461943|SUPERIORITY_OR_OTHER_LEGACY||Difference in LSM|-3.4|||=|0.0013|TWO_SIDED|95.0|-5.4|-1.3|||Mixed Models Analysis|||The least squares mean (LSM), the difference in LSM and its 95% confidence interval (CI), and the p-value were from a mixed effects model for repeated measures that included treatment group, visit, interaction of the treatment group with the visit as factors, baseline score as a covariate, and an adjustment for the interaction of the baseline score with the visit. The model was based on Restricted maximum likelihood (REML) method of estimation and utilized an unstructured covariance.||-1.3|-5.4|= 0.0013
70977055|NCT01552902|141461943|SUPERIORITY_OR_OTHER_LEGACY||Difference in LSM|-8.5|||<|0.0001|TWO_SIDED|95.0|-11.0|-6.0|||Mixed Models Analysis|||The LSM, the difference in LSM and its 95% CI, and the p-value were from a mixed effects model for repeated measures that included treatment group, visit, interaction of the treatment group with the visit as factors, baseline score as a covariate, and an adjustment for the interaction of the baseline score with the visit. The model was based on REML method of estimation and utilized an unstructured covariance.||-6|-11|< 0.0001
70977056|NCT01552902|141461943|SUPERIORITY_OR_OTHER_LEGACY||Difference in LSM|-5.1|||<|0.0001|TWO_SIDED|95.0|-7.6|-2.6|||Mixed Models Analysis|||The LSM, the difference in LSM and its 95% CI, and the p-value were from a mixed effects model for repeated measures that includes treatment group, visit, interaction of the treatment group with the visit as factors, baseline score as a covariate, and an adjustment for the interaction of the baseline score with the visit. The model was based on REML method of estimation and utilized an unstructured covariance.||-2.6|-7.6|< 0.0001
70977057|NCT06415305|141461957|SUPERIORITY||||||<|0.008|||||||Wilcoxon signed rank tests|||||||<0.008
70977058|NCT06415305|141461958|SUPERIORITY|||||||0.009|||||||Wilcoxon signed rank tests|||||||0.009
70977059|NCT06415305|141461959|SUPERIORITY|||||||0.008|||||||Wilcoxon signed rank tests|||||||0.008
70977060|NCT06415305|141461960|SUPERIORITY|||||||0.009|||||||Wilcoxon signed rank tests|||||||0.009
71034291|NCT04134091|141578317|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71034292|NCT04134091|141578318|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
71034293|NCT04134091|141578318|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
71034294|NCT04134091|141578319|SUPERIORITY||||||>|0.05|||||||ANCOVA|||Outcome Variable: Hepatocyte Ballooning Score||||>0.05
71034295|NCT04134091|141578319|SUPERIORITY||||||<|0.05|||||||ANCOVA|||Outcome Variable: Hepatocyte Ballooning Score||||<0.05
71034296|NCT04134091|141578319|SUPERIORITY||||||>|0.05|||||||ANCOVA|||Outcome Variable: Lobular Inflammation Score||||>0.05
71034297|NCT04134091|141578319|SUPERIORITY||||||>|0.05|||||||ANCOVA|||Outcome Variable: Lobular Inflammation Score||||>0.05
71034298|NCT04134091|141578319|SUPERIORITY||||||<|0.01|||||||ANCOVA|||Outcome Variable: Steatosis Score||||<0.01
71034299|NCT04134091|141578319|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Outcome Variable: Steatosis Score||||<0.001
71034300|NCT04134091|141578320|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
71034301|NCT04134091|141578320|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
71034302|NCT04134091|141578321|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
71095914|NCT03446573|141700277|OTHER||Mean Difference (Net)|-9.4|||<|0.001|TWO_SIDED|95.0|-14.0|-4.7|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum 25 hydroxyvitamin D at Week 96 has been presented.|||-4.7|-14.0|<0.001
70977061|NCT02487108|141461967|OTHER||LS Mean Difference|38.9|||<|0.001|TWO_SIDED|95.0|19.931|57.855|||ANCOVA|||Analysis was performed using ANCOVA with treatment and center as factors and the baseline pain intensity score as a covariate.||57.855|19.931|<0.001
70977062|NCT02487108|141461967|OTHER||LS Mean Difference|44.0|||<|0.001|TWO_SIDED|95.0|25.122|62.881|||ANCOVA|||Analysis was performed using ANCOVA with treatment and center as factors and the baseline pain intensity score as a covariate.||62.881|25.122|<0.001
70977063|NCT02487108|141461967|OTHER||LS Mean Difference|53.4|||<|0.001|TWO_SIDED|95.0|34.589|72.282|||ANCOVA|||Analysis was performed using ANCOVA with treatment and center as factors and the baseline pain intensity score as a covariate.||72.282|34.589|<0.001
70977064|NCT00600171|141461980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064||||0.208|TWO_SIDED|95.0|-0.036|0.164|||ANCOVA|||||0.164|-0.036|0.208
70977065|NCT00600171|141461980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069||||0.169|TWO_SIDED|95.0|-0.029|0.168|||ANCOVA|||||0.168|-0.029|0.169
70977066|NCT00600171|141461980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.011|TWO_SIDED|95.0|0.03|0.23|||ANCOVA|||||0.230|0.030|0.011
71034303|NCT04134091|141578321|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
70977067|NCT00600171|141461980|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.121||||0.016|TWO_SIDED|95.0|0.023|0.22|||ANCOVA|||||0.220|0.023|0.016
70977068|NCT00600171|141461980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162||||0.001|TWO_SIDED|95.0|0.062|0.261|||ANCOVA|||||0.261|0.062|0.001
70977069|NCT03990870|141462071|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
70977070|NCT03990870|141462074|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||0.35
70977071|NCT03990870|141462076|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
70977072|NCT01989221|141462077|SUPERIORITY||Mean Difference (Final Values)|0.55|STANDARD_DEVIATION|0.12|<|0.01|TWO_SIDED|95.0||||Threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean GCSI-DD scores during one week at baseline were compared to mean GCSI-DD scores during the second week of Sancuso treatment.|||||<0.01
70977073|NCT01989221|141462078|OTHER||Mean Difference (Final Values)|1.01|STANDARD_DEVIATION|0.27|<|0.01|TWO_SIDED|95.0||||Threshold for statistical significance was p \< 0.05|t-test, 2 sided||Mean nausea and vomiting symptom scores during one week at baseline were compared to mean symptom scores during the second week of Sancuso treatment.|||||<0.01
70977074|NCT01279057|141462079|EQUIVALENCE|If the 90% confidence intervals were contained within the interval 80.0% to 125.0%, then the two products were considered to be therapeutically equivalent.|Ratio Test/Ref. Least Squares (LS) Means|104.085|||||TWO_SIDED|90.0|87.421|124.21||||||||124.210|87.421|
70977075|NCT01279057|141462080|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70977076|NCT01279057|141462080|SUPERIORITY|||||||0.0001|||||||ANCOVA|||||||0.0001
70977077|NCT01279057|141462081|EQUIVALENCE|90% confidence intervals within the interval 80.0% to 125.0%.|Ratio Test/Ref. LS Means|106.635|||||TWO_SIDED|90.0|89.256|127.79||||||||127.790|89.256|
70977078|NCT01279057|141462082|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70977079|NCT01279057|141462082|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70977080|NCT01279057|141462083|EQUIVALENCE|90% confidence intervals within the interval 80.0% to 125.0%.|Ratio Test/Ref. LS Means|115.877|||||TWO_SIDED|90.0|94.129|143.949||||||||143.949|94.129|
70977081|NCT01279057|141462084|SUPERIORITY|||||||0.0018|||||||ANCOVA|||||||0.0018
70977082|NCT01279057|141462084|SUPERIORITY|||||||0.0441|||||||ANCOVA|||||||0.0441
70977083|NCT01279057|141462085|EQUIVALENCE|90% confidence intervals within the interval 80.0% to 125.0%.|Ratio Test/Ref. LS Means|117.712|||||TWO_SIDED|90.0|95.41|146.583||||||||146.583|95.410|
70977084|NCT01279057|141462086|SUPERIORITY|||||||0.0018|||||||ANCOVA|||||||0.0018
70977085|NCT01279057|141462086|SUPERIORITY|||||||0.0451|||||||ANCOVA|||||||0.0451
70977086|NCT00849017|141462102|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.84|||<|0.0001|TWO_SIDED|95.0|-1.11|-0.58|||ANCOVA|||||-0.58|-1.11|<0.0001
70977087|NCT00849017|141462102|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.04|||<|0.0001|TWO_SIDED|95.0|-1.31|-0.77|||ANCOVA|||||-0.77|-1.31|<0.0001
70977088|NCT01111305|141462141|EQUIVALENCE|Equivalence is defined as p≥0.05||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
70977089|NCT00624520|141462164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|891.0||||0.18|TWO_SIDED|||||Statistical Analysis presented for comparison groups Cognitive Behavioral Stress Management vs. Patient Education at 6 months post|ANOVA|||"Initial sample size calculation, based on previous published data of effects sizes of anger stress management on heart rate and blood pressure responses in a veteran population, indicated a study population of 138 patients should detect a reduction in Double Product response to mental stress following psychological intervention, with over 90% power, assuming 20% drop-out rate."||||0.18
70977090|NCT00624520|141462165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||0.02|TWO_SIDED||||||ANOVA|||||||0.02
70977091|NCT00624520|141462166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.003|TWO_SIDED||||||ANOVA|||||||0.003
71034304|NCT04134091|141578322|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
71034305|NCT04134091|141578322|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
71034306|NCT04134091|141578323|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
71034307|NCT04134091|141578323|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
71034308|NCT04134091|141578324|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
71034309|NCT04134091|141578324|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
71034310|NCT04134091|141578325|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: AST||||>0.05
71034311|NCT04134091|141578325|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||Outcome Variable: AST||||<0.01
71034312|NCT04134091|141578325|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: ALT||||>0.05
70977092|NCT00624520|141462167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.011|TWO_SIDED||||||ANOVA|||||||0.011
70977093|NCT00624520|141462168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.048|TWO_SIDED||||||ANOVA|||||||0.048
70977094|NCT00624520|141462169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0||||0.01|TWO_SIDED||||||ANOVA|||||||0.01
70977095|NCT00624520|141462170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.0||||0.01|TWO_SIDED||||||ANOVA|||||||0.01
70977096|NCT00624520|141462171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.02||||0.01|TWO_SIDED||||||ANOVA|||||||0.01
70977097|NCT00624520|141462172|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||Fisher Exact|||||||0.21
70977098|NCT00624520|141462173|SUPERIORITY_OR_OTHER||Effect size (Cohen's d)|0.38||||0.025|TWO_SIDED|||||P-value refers to a repeated measures within-group comparison in the CBSM group using ANCOVA with baseline DP elevation as covariate from baseline to 3 months post.|ANCOVA||Range of Cohen's d for small effect is 0.20 - 0.50|||||0.025
70977099|NCT00624520|141462174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|80.0||||0.81|TWO_SIDED|||||Statistical Analysis presented for comparison groups Cognitive Behavioral Stress Management vs. Patient Education at 6 months post|ANOVA|||"Initial sample size calculation, based on previous published data of effects sizes of anger stress management on heart rate and blood pressure responses in a veteran population, indicated a study population of 138 patients should detect a reduction in Double Product response to mental stress following psychological intervention, with over 90% power, assuming 20% drop-out rate."||||0.81
70977100|NCT01925209|141462176|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.59|STANDARD_ERROR_OF_MEAN|14.331||0.221|TWO_SIDED|99.0|-19.63|54.8|||mixed model repeated measures|||||54.80|-19.63|0.2210
70977101|NCT01925209|141462176|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.59|STANDARD_ERROR_OF_MEAN|14.176||0.1909|TWO_SIDED|99.0|-18.21|55.4|||mixed model repeated measure|||||55.40|-18.21|0.1909
71034313|NCT04134091|141578325|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||Outcome Variable: ALT||||< 0.01
70977102|NCT01925209|141462176|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.31|STANDARD_ERROR_OF_MEAN|14.121||0.9263|TWO_SIDED|99.0|-37.97|35.36|||mixed models repeated measures|||||35.36|-37.97|0.9263
70977103|NCT00110994|141462186|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.665||||0.068|TWO_SIDED|95.0|0.428|1.034|||log rank test|||||1.034|0.428|0.068
70977104|NCT00110994|141462187|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.992||||0.973|TWO_SIDED|95.0|0.627|1.57|||log rank test|||||1.570|0.627|0.973
70977105|NCT00110994|141462189|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.619||||0.039|TWO_SIDED|95.0|0.391|0.98|||log rank test|||||0.980|0.391|0.039
70977106|NCT00110994|141462190|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.427||||0.194|TWO_SIDED|95.0|0.114|1.601|||log rank test|||||1.601|0.114|0.194
70977107|NCT00110994|141462192|SUPERIORITY_OR_OTHER|||||||0.908||95.0|||||t-test, 2 sided|||||||0.908
70977108|NCT00110994|141462193|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||t-test, 2 sided|||||||0.890
70977109|NCT00110994|141462194|SUPERIORITY_OR_OTHER|||||||0.201||95.0|||||t-test, 2 sided|||||||0.201
70977110|NCT00110994|141462195|SUPERIORITY_OR_OTHER|||||||0.168||95.0|||||t-test, 2 sided|||||||0.168
70977111|NCT03158220|141462215|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.63|0.77||Analysis of variance (ANOVA) model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 16||0.77|0.63|< 0.001
70977112|NCT03158220|141462215|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.71|||<|0.001|TWO_SIDED|95.0|0.64|0.8||Analysis of variance (ANOVA) model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 18||0.80|0.64|< 0.001
70977113|NCT03158220|141462215|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.66|||<|0.001|TWO_SIDED|95.0|0.6|0.74||ANOVA model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 31||0.74|0.60|< 0.001
70977114|NCT03158220|141462215|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.73|||<|0.001|TWO_SIDED|95.0|0.67|0.8||ANOVA model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 33||0.80|0.67|< 0.001
71034314|NCT04134091|141578325|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: ALP||||>0.05
71034315|NCT04134091|141578325|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Outcome Variable: ALP||||<0.05
71034316|NCT04134091|141578325|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: GGT||||>0.05
71034317|NCT04134091|141578325|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Outcome Variable: GGT||||<0.05
71034318|NCT04134091|141578326|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: Total cholesterol||||>0.05
71034319|NCT04134091|141578326|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: Total cholesterol||||>0.05
71034320|NCT04134091|141578326|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: LDL||||>0.05
71034321|NCT04134091|141578326|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: LDL||||>0.05
71034322|NCT04134091|141578326|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: HDL||||>0.05
71095915|NCT03446573|141700277|OTHER||Mean Difference (Net)|-5.6||||0.005|TWO_SIDED|95.0|-9.4|-1.7|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum 25 hydroxyvitamin D at Week 144 has been presented.|||-1.7|-9.4|0.005
70977115|NCT03158220|141462215|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.68|||<|0.001|TWO_SIDED|95.0|0.6|0.76||ANOVA model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 45||0.76|0.60|< 0.001
71095916|NCT03446573|141700278|OTHER||Mean Difference (Net)|-0.01||||0.027|TWO_SIDED|95.0|-0.03|0.0|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum cystatin C at Week 24 has been presented|||0.00|-0.03|0.027
70977116|NCT03158220|141462215|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.71|||<|0.001|TWO_SIDED|95.0|0.64|0.78||ANOVA model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 52||0.78|0.64|< 0.001
70977117|NCT03158220|141462215|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.69|||<|0.001|TWO_SIDED|95.0|0.63|0.76||ANOVA model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 58||0.76|0.63|< 0.001
70977118|NCT03158220|141462218|OTHER||Difference in Percentages|-2.5||||0.212|TWO_SIDED|95.0|-6.4|1.4|||Miettinen & Nurminen||Difference in percentages calculated as % Women 27-45 Years of Age minus % Women 16-26 Years of Age.|||1.4|-6.4|0.212
70977119|NCT03158220|141462219|OTHER||Difference in Percentages|-1.9|||||TWO_SIDED|95.0|-7.3|3.4|||||Difference in percentages calculated as % Women 27-45 Years of Age minus % Women 16-26 Years of Age.|||3.4|-7.3|
70977120|NCT03158220|141462220|OTHER||Difference in Percentages|-1.0||||0.3|TWO_SIDED|95.0|-3.1|0.9|||Miettinen & Nurminen||Difference in percentages calculated as % Women 27-45 Years of Age minus % Women 16-26 Years of Age.|||0.9|-3.1|0.300
70977121|NCT00848120|141462315|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Week 24 versus baseline||||<0.001
70977122|NCT00848120|141462316|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Week 24 versus baseline||||<0.001
70977123|NCT00848120|141462317|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|||Week 24 versus baseline||||0.001
70977124|NCT01988090|141462324|SUPERIORITY|||||||0.7635|||||||Chi-squared|||||||0.7635
70977125|NCT01988090|141462326|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
70977126|NCT04343651|141462360|SUPERIORITY|||||||0.818|||||||ANCOVA|||||||0.818
70977127|NCT04343651|141462361|SUPERIORITY||Hazard Ratio (HR)|0.781||||0.4138|TWO_SIDED|95.0|0.43|1.41|||Likelihood test-Cox Prop. hazards model|Stratification factors: Baseline NEWS Total score and Age.||||1.41|0.43|0.4138
70977128|NCT02587338|141462405|SUPERIORITY|||||||0.74|||||||ANOVA|||||||0.74
70977129|NCT02587338|141462406|SUPERIORITY|||||||0.062|||||||t-test, 2 sided|||||||0.062
70977130|NCT01506882|141462407|SUPERIORITY_OR_OTHER||Percent|73.8|||||TWO_SIDED|95.0|60.9|84.2||||||"The primary efficacy variable was to be calculated as the proportion p=n/N of subjects (n) staying seizure free for 6 months out of the total number of subjects (N). For this proportion p, an exact 2-sided 95% confidence interval (CI) was computed based on the F distribution.~The hypothesis H0: p=0.4 was to be formally rejected in favor of H1: p\>0.4, if the lower confidence limit for p was greater than 0.4."||84.2|60.9|
70977131|NCT01302808|141462415|OTHER||Maximum Tolerated Dose|8.0|||||TWO_SIDED|||||||||||||
70977132|NCT00821678|141462417|SUPERIORITY_OR_OTHER||Slope|-3.81||||0.002|TWO_SIDED|95.0|-6.19|-1.43|||Mixed Models Analysis|||||-1.43|-6.19|0.002
70977133|NCT00821678|141462418|SUPERIORITY_OR_OTHER||Slope|-0.25||||0.001|TWO_SIDED|95.0|-0.4|-0.1|||Mixed Models Analysis|||||-0.1|-0.4|0.001
70977134|NCT00821678|141462419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.48|TWO_SIDED|95.0|-0.33|0.7|||t-test, 2 sided|||||0.70|-0.33|0.48
70977135|NCT00821678|141462420|SUPERIORITY_OR_OTHER||Slope|2.67||||0.02|TWO_SIDED|95.0|0.45|4.91|||Mixed Models Analysis|||||4.91|0.45|0.02
70977136|NCT00821678|141462423|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.86||||0.65|TWO_SIDED|95.0|0.46|1.62|||Mixed Models Analysis|||||1.62|0.46|0.65
70977137|NCT00821678|141462424|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.9|||<|0.001|TWO_SIDED|95.0|3.2|19.6|||Mixed Models Analysis|||||19.6|3.2|<0.001
70977138|NCT02064764|141462453|OTHER|Log-Rank Test For Comparing Treatment and Control||||||0.28|||||||Log Rank|||||||0.28
70977139|NCT02064764|141462454|OTHER|||||||0.7348|||||||Log Rank|||||||0.7348
70977140|NCT02348099|141462499|OTHER|"A student's paired t-test will be used to determine the difference if any in CV of Glucose between injection sites. In the third phase, area under the curve will be measured to determine differences between insulin absorption levels. Statistical analysis will be performed using SPSS version 15.0.0 and SAS version 8.2 A power calculation is a statistical method used to determine the minimum sample size needed to detect a statistically significant effect of a certain size."|Odds Ratio (OR)|95.0|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||"A student's paired t-test will be used to determine the difference if any in CV of glucose between injection sited.~If the null hypothesis is true, it suggests that any changes witnessed in an experiment are because of random chance and not because of changes made to variables in the experiment. A power calculation is a statistical method used to determine the minimum sample size needed to detect a statistically significant effect of a certain size."|a P-Value is \<0.01|||<0.01
71095917|NCT03446573|141700278|OTHER||Mean Difference (Net)|-0.01||||0.061|TWO_SIDED|95.0|-0.03|0.0|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum cystatin C at Week 48 has been presented|||0.00|-0.03|0.061
70977141|NCT02411448|141462554|OTHER||Hazard Ratio (HR)|0.591|||<|0.0001|TWO_SIDED|95.0|0.461|0.76|||Log Rank|||||0.760|0.461|<0.0001
70977142|NCT02411448|141462556|OTHER||Hazard Ratio (HR)|0.832||||0.4209|TWO_SIDED|95.0|0.532|1.303|||Log Rank|||||1.303|0.532|0.4209
70977143|NCT02411448|141462557|OTHER|||||||0.7413|||||||Cochran-Mantel-Haenszel|||||||0.7413
70977144|NCT02411448|141462558|OTHER|||||||1|||||||Cochran-Mantel-Haenszel|||||||1.0000
70977145|NCT02411448|141462559|OTHER||Hazard Ratio (HR)|0.619||||0.0003|TWO_SIDED|95.0|0.477|0.805|||Log Rank|||||0.805|0.477|0.0003
70977146|NCT01577238|141462586|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70977147|NCT01256177|141462593|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-3.22|STANDARD_ERROR_OF_MEAN|1.1||0.004|TWO_SIDED|95.0|-5.39|-1.04|||Mixed Model Repeated Measures (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 8 in MADRS total score based on observed cases (OC)||-1.04|-5.39|0.004
70977148|NCT01256177|141462594|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.54||||0.001|TWO_SIDED|95.0|1.56|4.13|||Regression, Logistic|Odds ratio was modeled by logistic regression adjusted for centre, baseline score, and bipolar strata.|Quetiapine XR/Placebo|||4.13|1.56|0.001
70977149|NCT01256177|141462595|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.37||||0.001|TWO_SIDED|95.0|1.46|3.86|||Regression, Logistic|Odds ratio was modeled by logistic regression adjusted for centre, baseline score, and bipolar strata.|Quetiapine XR/Placebo|||3.86|1.46|0.001
70977150|NCT01256177|141462596|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-1.47|STANDARD_ERROR_OF_MEAN|0.67||0.029|TWO_SIDED|95.0|-2.79|-0.15|||Mixed Model Repeated Measure (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 1 in MADRS total score based on observed cases (OC)||-0.15|-2.79|0.029
70977151|NCT01256177|141462596|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-2.43|STANDARD_ERROR_OF_MEAN|0.88||0.006|TWO_SIDED|95.0|-4.16|-0.69|||Mixed Model Repeated Measure (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 2 in MADRS total score based on observed cases (OC)||-0.69|-4.16|0.006
70977152|NCT01256177|141462596|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-3.12|STANDARD_ERROR_OF_MEAN|0.95||0.001|TWO_SIDED|95.0|-5.0|-1.25|||Mixed Model Repeated Measures (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 4 in MADRS total score based on observed cases (OC)||-1.25|-5.00|0.001
70977153|NCT01256177|141462596|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-2.08|STANDARD_ERROR_OF_MEAN|1.03||0.045|TWO_SIDED|95.0|-4.12|-0.05|||Mixed Model Repeated Measures (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 6 in MADRS total score based on observed cases (OC)||-0.05|-4.12|0.045
70977154|NCT01256177|141462596|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-3.22|STANDARD_ERROR_OF_MEAN|1.1||0.004|TWO_SIDED|95.0|-5.39|-1.04|||Mixed Model Repeated Measures (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 8 in MADRS total score based on observed cases (OC)||-1.04|-5.39|0.004
70977155|NCT01256177|141462597|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-2.24|STANDARD_ERROR_OF_MEAN|0.83||0.007|TWO_SIDED|95.0|-3.88|-0.61|||Mixed Model Repeated Measures (MMRM)|Baseline HAM-D total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 8 in HAM-D total score based on observed cases (OC)||-0.61|-3.88|0.007
70977156|NCT01256177|141462598|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-0.51|STANDARD_ERROR_OF_MEAN|0.17||0.003|TWO_SIDED|95.0|-0.84|-0.17|||Mixed Model Repeated Measures (MMRM)|Baseline CGI-BP-S score for overall BP illness as covariate, trt, bipolar strata, visit, trt-visit interaction as fixed effect and centre as random.||Change from baseline to Week 8 assessment in the CGI-BP-S score for overall Bipolar (BP) illness based on observed cases (OC)||-0.17|-0.84|0.003
70977157|NCT01256177|141462598|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-0.47|STANDARD_ERROR_OF_MEAN|0.17||0.007|TWO_SIDED|95.0|-0.81|-0.13|||Mixed Model Repeated Measures (MMRM)|Baseline CGI-BP-S score for depression as covariate, trt, Bipolar strata, visit, trt-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 8 assessment in the CGI-BP-S score of depression based on observed cases (OC)||-0.13|-0.81|0.007
70977158|NCT01256177|141462599|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06||||0.004|TWO_SIDED|95.0|1.26|3.36|||Regression, Logistic|Odds ratio between treatment groups was modeled by logistic regression adjusted for centre, baseline score and bipolar Strata.|Quetiapine XR/Placebo|||3.36|1.26|0.004
70977159|NCT01256177|141462600|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.005|TWO_SIDED|95.0|-0.38|-0.07|||Mixed Model Repeated Measures (MMRM)|Baseline MADRS item 10 score as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effect and centre as random.||Change from Baseline to Week 8 in MADRS item 10 score for suicidal ideation based on observed cases (OC)||-0.07|-0.38|0.005
70977160|NCT01256177|141462601|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.26||||0.233|TWO_SIDED|95.0|0.03|2.38|||Regression, Logistic|Odds ratio between treatment groups was modeled by logistic regression adjusted for centre, strata and baseline score.|Quetiapine XR/Placebo|||2.38|0.03|0.233
71008744|NCT02055976|141525249|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-34.933|STANDARD_ERROR_OF_MEAN|14.832||0.01|TWO_SIDED|95.0|-64.41|-5.456|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-5.456|-64.410|0.010
71034323|NCT04134091|141578326|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: HDL||||>0.05
70977161|NCT01110395|141462602|OTHER|Bland and Altman|Mean + SD|0.05|STANDARD_ERROR_OF_MEAN|1.96|||TWO_SIDED|||||Bland Altman|mean + SD|Bland Altman|We have provided all the information that is available to us. The PI has left the institution and we are unable to contact him. We have no further data to correct the errors.|We are unable to provide any further data that has been requested. We have supplied all the data that we can possibly provide because the PI has left the institution and we are unable to contact him. We have no other data.|There are no other statistical analysis. We have provided all the information that is available to us. We have no other data available to us because the PI has left the institution and we are unable to contact him.|||
70977162|NCT01110395|141462602|OTHER||||||<|0.05|||||||Mean + SD|||||||<0.05
70977163|NCT04398732|141462612|OTHER|||||||0.0001|||||||Student's t-test|||Statistical analysis was performed on change from Baseline in percent BSA at Month 12.||||0.0001
70977164|NCT04398732|141462613|OTHER|||||||0.0001|||||||Student's t-test|||Statistical analysis was performed on change from baseline in DLQI at Month 12.||||0.0001
70977165|NCT04398732|141462614|OTHER|||||||0.0001|||||||Student's t-test|||Statistical analysis was performed on change from baseline in PASI at Month 12.||||0.0001
70977166|NCT04398732|141462615|OTHER|||||||0.036|||||||Student's t-test|||Baseline||||0.036
70977167|NCT04398732|141462615|OTHER|||||||0.0001|||||||Student's t-test|||Month 4||||0.0001
70977168|NCT04398732|141462615|OTHER|||||||0.0001|||||||Student's t-test|||Month 12||||0.0001
70977169|NCT04398732|141462616|OTHER|||||||0.42|||||||Student's t-test|||Baseline||||0.42
70977170|NCT04398732|141462616|OTHER|||||||0.0001|||||||Student's t-test|||Month 4||||0.0001
70977171|NCT04398732|141462616|OTHER|||||||0.0001|||||||Student's t-test|||Month 12||||0.0001
70977172|NCT04398732|141462617|OTHER|||||||0.72|||||||Student's t-test|||Baseline||||0.72
70977173|NCT04398732|141462617|OTHER|||||||0.0001|||||||Student's t-test|||Month 4||||0.0001
70977174|NCT04398732|141462617|OTHER|||||||0.0001|||||||Student's t-test|||Month 12||||0.0001
70977175|NCT04398732|141462618|OTHER|||||||0.0001|||||||Student's t-test|||Statistical analysis was performed on change from Baseline in percent BSA at Month 4.||||0.0001
70977176|NCT04398732|141462619|OTHER|||||||0.0001|||||||Student's t-test|||Statistical analysis was performed on change from baseline in DLQI at Month 4.||||0.0001
70977177|NCT04398732|141462620|OTHER|||||||0.0001|||||||Student's t-test|||Statistical analysis was performed on change from baseline in PASI at Month 4.||||0.0001
70977178|NCT01570244|141462631|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|140.96|STANDARD_DEVIATION|8.1|||TWO_SIDED|90.0|133.84|148.47|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Ethinylestradiol||148.47|133.84|
71095918|NCT03446573|141700280|OTHER||Mean Difference (Net)|-0.03||||0.004|TWO_SIDED|95.0|-0.06|-0.01|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum cystatin C at Week 96 has been presented|||-0.01|-0.06|0.004
71095919|NCT03446573|141700280|OTHER||Mean Difference (Net)|-0.01||||0.094|TWO_SIDED|95.0|-0.03|0.0|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum cystatin C at Week 144 has been presented|||0.00|-0.03|0.094
70977179|NCT01570244|141462632|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Odds Ratio (OR)|114.82|STANDARD_DEVIATION|13.2|||TWO_SIDED|90.0|105.49|124.97|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Ethinylestradiol||124.97|105.49|
70977180|NCT01570244|141462633|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|171.37|STANDARD_DEVIATION|10.5|||TWO_SIDED|90.0|160.2|183.33|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Ethinylestradiol||183.33|160.20|
70977181|NCT01570244|141462636|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric mean ratio|140.53|STANDARD_DEVIATION|4.6|||TWO_SIDED|90.0|136.4|144.78|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Levonorgestrel||144.78|136.40|
70977182|NCT01570244|141462637|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|115.28|STANDARD_DEVIATION|6.1|||TWO_SIDED|90.0|110.81|119.92|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Levonorgestrel||119.92|110.81|
70977183|NCT01570244|141462638|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|153.85|STANDARD_DEVIATION|8.2|||TWO_SIDED|90.0|145.99|162.14|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Levonorgestrel||162.14|145.99|
70977184|NCT05617521|141462642|SUPERIORITY|Sample size was assessed over the primary outcome of the study based on pre-experimental data estimation. It was calculated that 142 participants were needed to detect a 60-second difference in CIT, with 90% power and two-side alpha 0.05. It was found that 186 participants were needed to detect a 20% reduction in the use of ancillary maneuvers. As a preventive measure in case of withdrawal or exclusion, the sample was expanded by 10%, a total of 206 patients||||||0.008||||||The comparative analysis of the CIT was previously subjected to normality evaluation by the Shapiro-Wilk test. According to the rejection of normal distribution, comparative data analysis has been performed with a two-way Mann-Whitney U test|Wilcoxon (Mann-Whitney)|||||||0.008
70977185|NCT05617521|141462643|SUPERIORITY|Sample size was assessed over the primary outcome of the study based on pre-experimental data estimation. It was calculated that 142 participants were needed to detect a 60-second difference in CIT, with 90% power and two-side alpha 0.05. It was found that 186 participants were needed to detect a 20% reduction in the use of ancillary maneuvers. As a preventive measure in case of withdrawal or exclusion, the sample was expanded by 10%, a total of 206 patients.|||||<|0.001||||||For the comparison of abdominal pressure, Pearson chi-square test was used. The statistical significance level was accepted as p \<0.05|Chi-squared|||||||<0.001
70977186|NCT05617521|141462644|SUPERIORITY||||||<|0.001||||||The comparative analysis of the CIL was previously subjected to normality evaluation by the Shapiro-Wilk test. According to the rejection of normal distribution, comparative data analysis has been performed with a two-way Mann-Whitney U test|Wilcoxon (Mann-Whitney)|||||||<0.001
70977187|NCT05617521|141462645|SUPERIORITY|||||||0.321|||||||Chi-squared|||||||0.321
70977188|NCT05617521|141462646|SUPERIORITY|||||||0.75|||||||Fisher Exact|||||||0.75
70977189|NCT05617521|141462647|SUPERIORITY|||||||0.005|||||||Chi-squared|||||||0.005
70977190|NCT05617521|141462648|OTHER|||||||0.8|||||||Fisher Exact|||||||0.8
70977191|NCT05617521|141462650|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
70977192|NCT05617521|141462651|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70977193|NCT05617521|141462652|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70977194|NCT05617521|141462653|SUPERIORITY|Sample size was assessed over the primary outcome of the study based on pre-experimental data estimation. It was calculated that 142 participants were needed to detect a 60-second difference in CIT, with 90% power and two-side alpha 0.05. It was found that 186 participants were needed to detect a 20% reduction in the use of ancillary maneuvers. As a preventive measure in case of withdrawal or exclusion, the sample was expanded by 10%, a total of 206 patients.||||||0.01||||||For the comparison of position change, Pearson chi-square test was used. The statistical significance level was accepted as p \<0.05|Chi-squared|||||||0.01
70977195|NCT05617521|141462654|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
70977196|NCT00792298|141462670|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|12.9|||<|0.001|TWO_SIDED|95.0|9.5|16.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||16.3|9.5|<0.001
70977197|NCT00792298|141462670|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|7.6|||<|0.001|TWO_SIDED|95.0|4.4|10.9|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||10.9|4.4|<0.001
71034324|NCT04134091|141578326|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: triglycerides||||>0.05
71034325|NCT04134091|141578326|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: triglycerides||||>0.05
71034326|NCT00796653|141578327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.091|0.167|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.167|0.091|<0.0001
71034327|NCT00796653|141578327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.116|0.191|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.191|0.116|<0.0001
71034328|NCT00796653|141578327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.112|0.188|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.188|0.112|<0.0001
71034329|NCT00796653|141578328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.019||0.0055||95.0|0.015|0.09|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.090|0.015|0.0055
71034330|NCT00796653|141578328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.019||0.0003||95.0|0.032|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.106|0.032|0.0003
71034331|NCT00796653|141578328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.019||0.027||95.0|0.005|0.08|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.080|0.005|0.0270
71034332|NCT00796653|141578329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.402|STANDARD_ERROR_OF_MEAN|0.314||0.1999||95.0|-0.213|1.018|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.018|-0.213|0.1999
71034333|NCT00796653|141578329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.419|STANDARD_ERROR_OF_MEAN|0.314||0.1818||95.0|-0.196|1.035|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.035|-0.196|0.1818
71095920|NCT03446573|141700281|OTHER||Mean Difference (Net)|1.8||||0.012|TWO_SIDED|95.0|0.4|3.1|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from cystatin C adjusted using CKD-EPI at Week 24 has been presented|||3.1|0.4|0.012
71095921|NCT03446573|141700281|OTHER||Mean Difference (Net)|1.6||||0.059|TWO_SIDED|95.0|-0.1|3.3|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from cystatin C adjusted using CKD-EPI at Week 48 has been presented|||3.3|-0.1|0.059
70977198|NCT00792298|141462670|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|10.8|||<|0.001|TWO_SIDED|95.0|7.4|14.2|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||14.2|7.4|<0.001
70977199|NCT00792298|141462670|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|7.8|||<|0.001|TWO_SIDED|95.0|4.6|10.9|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||10.9|4.6|<0.001
70977200|NCT00792298|141462670|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|7.6|||<|0.001|TWO_SIDED|95.0|4.2|11.0|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||11.0|4.2|<0.001
70977201|NCT00792298|141462670|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|10.4|||<|0.001|TWO_SIDED|95.0|7.2|13.6|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||13.6|7.2|<0.001
70977202|NCT00792298|141462670|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|5.2||||0.002|TWO_SIDED|95.0|1.9|8.6|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||8.6|1.9|0.002
70977203|NCT00792298|141462670|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|4.7||||0.003|TWO_SIDED|95.0|1.6|7.8|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||7.8|1.6|0.003
70977204|NCT00792298|141462671|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-36.8|||<|0.001|TWO_SIDED|95.0|-49.4|-24.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-24.3|-49.4|<0.001
70977205|NCT00792298|141462671|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-28.9|||<|0.001|TWO_SIDED|95.0|-42.1|-15.7|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-15.7|-42.1|<0.001
70977206|NCT00792298|141462671|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-33.9|||<|0.001|TWO_SIDED|95.0|-46.4|-21.5|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-21.5|-46.4|<0.001
71095922|NCT03446573|141700281|OTHER||Mean Difference (Net)|-5.0|||<|0.001|TWO_SIDED|95.0|-6.3|-3.7|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from creatinine adjusted using CKD-EPI at Week 24 has been presented|||-3.7|-6.3|<0.001
71095923|NCT03446573|141700281|OTHER||Mean Difference (Net)|-4.8|||<|0.001|TWO_SIDED|95.0|-6.1|-3.4|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from creatinine adjusted using CKD-EPI at Week 48 has been presented|||-3.4|-6.1|<0.001
71095924|NCT03446573|141700283|OTHER||Mean Difference (Net)|4.1||||0.002|TWO_SIDED|95.0|1.5|6.7|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from cystatin C adjusted using CKD-EPI at Week 96 has been presented|||6.7|1.5|0.002
70977207|NCT00792298|141462671|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-33.2|||<|0.001|TWO_SIDED|95.0|-46.3|-20.2|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-20.2|-46.3|<0.001
70977208|NCT00792298|141462671|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-24.7|||<|0.001|TWO_SIDED|95.0|-37.1|-12.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-12.3|-37.1|<0.001
70977209|NCT00792298|141462671|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-28.1|||<|0.001|TWO_SIDED|95.0|-41.0|-15.1|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-15.1|-41.0|<0.001
70977210|NCT00792298|141462671|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-21.2|||<|0.001|TWO_SIDED|95.0|-33.5|-8.8|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-8.8|-33.5|<0.001
70977211|NCT00792298|141462671|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-21.4||||0.001|TWO_SIDED|95.0|-34.2|-8.7|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-8.7|-34.2|0.001
70977212|NCT00792298|141462672|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-25.4|||<|0.001|TWO_SIDED|95.0|-37.7|-13.1|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-13.1|-37.7|<0.001
70977213|NCT00792298|141462672|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-9.5||||0.068|TWO_SIDED|95.0|-19.7|0.7|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||0.7|-19.7|0.068
70977214|NCT00792298|141462672|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-23.1|||<|0.001|TWO_SIDED|95.0|-35.3|-10.9|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-10.9|-35.3|<0.001
71034334|NCT00796653|141578329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.602|STANDARD_ERROR_OF_MEAN|0.316||0.0572||95.0|-0.019|1.222|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.222|-0.019|0.0572
70977215|NCT00792298|141462672|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-3.8||||0.459|TWO_SIDED|95.0|-13.8|6.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||6.3|-13.8|0.459
71034335|NCT00796653|141578330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.15|STANDARD_ERROR_OF_MEAN|1.349||0.0197||95.0|-5.796|-0.503|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.503|-5.796|0.0197
71095925|NCT03446573|141700283|OTHER||Mean Difference (Net)|1.9||||0.064|TWO_SIDED|95.0|-0.1|3.8|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from cystatin C adjusted using CKD-EPI at Week 148 has been presented|||3.8|-0.1|0.064
70977216|NCT00792298|141462672|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-9.4||||0.13|TWO_SIDED|95.0|-21.5|2.8|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||2.8|-21.5|0.130
71034336|NCT00796653|141578330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.524|STANDARD_ERROR_OF_MEAN|1.354||0.0094||95.0|-6.18|-0.867|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.867|-6.180|0.0094
70977217|NCT00792298|141462672|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-22.3|||<|0.001|TWO_SIDED|95.0|-32.3|-12.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-12.3|-32.3|<0.001
70977218|NCT00792298|141462672|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-3.4||||0.577|TWO_SIDED|95.0|-15.6|8.7|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||8.7|-15.6|0.577
71034337|NCT00796653|141578330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.416|STANDARD_ERROR_OF_MEAN|1.365||0.2995||95.0|-4.093|1.261|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.261|-4.093|0.2995
70977219|NCT00792298|141462672|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-2.3||||0.644|TWO_SIDED|95.0|-12.2|7.5|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||7.5|-12.2|0.644
70977220|NCT00792298|141462673|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-22.3||||0.007|TWO_SIDED|95.0|-38.3|-6.2|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-6.2|-38.3|0.007
71008745|NCT02055976|141525249|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.978|STANDARD_ERROR_OF_MEAN|11.725||0.064|TWO_SIDED|95.0|-41.282|5.326|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||5.326|-41.282|0.064
71008746|NCT02055976|141525249|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.654|STANDARD_ERROR_OF_MEAN|11.903||0.318|TWO_SIDED|95.0|-29.311|18.004|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||18.004|-29.311|0.318
71008747|NCT02055976|141525249|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-19.435|STANDARD_ERROR_OF_MEAN|11.807||0.052|TWO_SIDED|95.0|-42.902|4.032|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||4.032|-42.902|0.052
71008748|NCT02055976|141525250|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-25.974|STANDARD_ERROR_OF_MEAN|7.674|<|0.001|TWO_SIDED|95.0|-41.217|-10.731|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-10.731|-41.217|<0.001
71008749|NCT02055976|141525250|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-21.11|STANDARD_ERROR_OF_MEAN|7.831||0.004|TWO_SIDED|95.0|-36.665|-5.555|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-5.555|-36.665|0.004
71008750|NCT02055976|141525250|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-31.034|STANDARD_ERROR_OF_MEAN|7.917|<|0.001|TWO_SIDED|95.0|-46.758|-15.31|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-15.310|-46.758|<0.001
71095926|NCT03446573|141700283|OTHER||Mean Difference (Net)|-5.2|||<|0.001|TWO_SIDED|95.0|-6.7|-3.8|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from creatinine adjusted using CKD-EPI at Week 96 has been presented|||-3.8|-6.7|<0.001
70977221|NCT00792298|141462673|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-19.6||||0.024|TWO_SIDED|95.0|-36.6|-2.6|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-2.6|-36.6|0.024
70977222|NCT00792298|141462673|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-31.0|||<|0.001|TWO_SIDED|95.0|-46.9|-15.2|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-15.2|-46.9|<0.001
70977223|NCT00792298|141462673|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-15.7||||0.063|TWO_SIDED|95.0|-32.3|0.8|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||0.8|-32.3|0.063
70977224|NCT00792298|141462673|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-17.4||||0.03|TWO_SIDED|95.0|-33.1|-1.7|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-1.7|-33.1|0.030
70977225|NCT00792298|141462673|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-24.6||||0.003|TWO_SIDED|95.0|-41.0|-8.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-8.3|-41.0|0.003
70977226|NCT00792298|141462673|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-19.1||||0.02|TWO_SIDED|95.0|-35.1|-3.0|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-3.0|-35.1|0.020
70977227|NCT00792298|141462673|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-20.2||||0.019|TWO_SIDED|95.0|-37.0|-3.4|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-3.4|-37.0|0.019
70977228|NCT02388295|141462675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.24||0.13|ONE_SIDED|||||Not adjusted|ANOVA||larger negative values (powered to detect -0.50)|Change from baseline within treatment arm||||0.13
71095927|NCT03446573|141700283|OTHER||Mean Difference (Net)|-4.5|||<|0.001|TWO_SIDED|95.0|-6.2|-2.8|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from creatinine adjusted using CKD-EPI at Week 144 has been presented|||-2.8|-6.2|<0.001
71095928|NCT03446573|141700284|OTHER||Mean Difference (Net)|4.37|||<|0.001|TWO_SIDED|95.0|3.03|5.7|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TBR) and its 95% CI for serum creatinine at Week 24 has been presented.|||5.70|3.03|<0.001
71095929|NCT03446573|141700284|OTHER||Mean Difference (Net)|4.49|||<|0.001|TWO_SIDED|95.0|3.18|5.81|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TBR) and its 95% CI for serum creatinine at Week 48 has been presented.|||5.81|3.18|<0.001
71095930|NCT03446573|141700286|OTHER||Mean Difference (Net)|4.95|||<|0.001|TWO_SIDED|95.0|3.47|6.43|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TBR) and its 95% CI for serum creatinine at Week 96 has been presented.|||6.43|3.47|<0.001
70977229|NCT02388295|141462675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.25||0.91|ONE_SIDED|||||not adjusted|ANOVA||larger negative values (powered to detect -0.50)|Change from baseline||||0.91
70977230|NCT02388295|141462675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.25||0.68|ONE_SIDED||||||ANOVA|no adjustments|larger negagtive values (powereed to detect -0.50)|Change from baseline||||0.68
71095931|NCT03446573|141700286|OTHER||Mean Difference (Net)|4.08|||<|0.001|TWO_SIDED|95.0|2.32|5.85|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TBR) and its 95% CI for serum creatinine at Week 144 has been presented.|||5.85|2.32|<0.001
71095932|NCT03446573|141700287|OTHER||Mean Difference (Net)|-0.0017||||0.741|TWO_SIDED|95.0|-0.0119|0.0085|||Mixed Model Repeated Measures||Week 24. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Utility (continuous), Treatment by Visit interaction, and Baseline EQ-5D Utility by Visit interaction, with Visit as the repeated factor.|||0.0085|-0.0119|0.741
71034338|NCT00796653|141578331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.352|STANDARD_ERROR_OF_MEAN|1.385||0.7995||95.0|-3.068|2.365|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||2.365|-3.068|0.7995
71034339|NCT00796653|141578331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|1.391||0.4336||95.0|-3.818|1.639|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.639|-3.818|0.4336
71034340|NCT00796653|141578331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|1.395||0.9365||95.0|-2.625|2.848|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||2.848|-2.625|0.9365
71034341|NCT00796653|141578332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.625|STANDARD_ERROR_OF_MEAN|1.333||0.0491||95.0|-5.241|-0.01|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.010|-5.241|0.0491
71034342|NCT00796653|141578332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.489|STANDARD_ERROR_OF_MEAN|1.341||0.0636||95.0|-5.119|0.141|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.141|-5.119|0.0636
71034343|NCT00796653|141578332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.158|STANDARD_ERROR_OF_MEAN|1.35||0.0194||95.0|-5.806|-0.511|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||-0.511|-5.806|0.0194
71034344|NCT00796653|141578333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.846|STANDARD_ERROR_OF_MEAN|0.972||0.0034|TWO_SIDED|95.0|-4.751|-0.94|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect||Olo 5 mcg minus placebo||-0.940|-4.751|0.0034
71034345|NCT00796653|141578333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.434|STANDARD_ERROR_OF_MEAN|0.973||0.0004|TWO_SIDED|95.0|-5.343|-1.525|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect||Olo 10 mcg minus placebo||-1.525|-5.343|0.0004
71034346|NCT00796653|141578333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.248|STANDARD_ERROR_OF_MEAN|0.976||0.2009|TWO_SIDED|95.0|-3.161|0.665|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect||Form 12 mcg minus placebo||0.665|-3.161|0.2009
71034347|NCT00796653|141578334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.123|0.196|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.196|0.123|<0.0001
71034348|NCT00796653|141578334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.193|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.157|0.229|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.229|0.157|<0.0001
71034349|NCT00796653|141578334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.126|0.199|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.199|0.126|<0.0001
71034350|NCT00796653|141578335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.136|0.209|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.209|0.136|<0.0001
71034351|NCT00796653|141578335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.155|0.228|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.228|0.155|<0.0001
71034352|NCT00796653|141578335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.148|0.221|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.221|0.148|<0.0001
71034353|NCT00796653|141578336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.108|0.182|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.182|0.108|<0.0001
71034354|NCT00796653|141578336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.138|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.212|0.138|<0.0001
71034355|NCT00796653|141578336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.133|0.208|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.208|0.133|<0.0001
71034356|NCT00796653|141578337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.08|0.156|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.156|0.080|<0.0001
71034357|NCT00796653|141578337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.103|0.18|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.180|0.103|<0.0001
71034358|NCT00796653|141578337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.091|0.168|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.168|0.091|<0.0001
71034359|NCT00796653|141578338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.018||0.0002||95.0|0.033|0.105|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.105|0.033|0.0002
71034360|NCT00796653|141578338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.083|0.155|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.155|0.083|<0.0001
70977231|NCT02388295|141462675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.34||0.32|TWO_SIDED|||||no adjustment|ANOVA||Looking for negative direction to indicate treatment better than placebo|Secondary objective - comparison to placebo||||0.32
70977232|NCT02388295|141462675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.36||0.45|TWO_SIDED|||||no adjustment|ANOVA||lookin for negative difference compared to placebo|Secondary objective||||0.45
70977233|NCT04258579|141462683|OTHER|Estimation only.|Mean value at 6 weeks|19.13|||||TWO_SIDED|95.0|15.59|22.67||||||||22.67|15.59|
70977234|NCT04258579|141462683|OTHER|Estimation only.|Mean value at 9 weeks|16.87|||||TWO_SIDED|95.0|12.5|21.24||||||||21.24|12.50|
70977235|NCT04258579|141462683|OTHER|Estimation only.|Mean value at 12 weeks|15.0|||||TWO_SIDED|95.0|11.24|18.76||||||||18.76|11.24|
70977236|NCT04258579|141462684|OTHER|Estimation only.|Mean value at 6 weeks, Domain 1|22.1|||||TWO_SIDED|95.0|19.7|24.5||||||||24.50|19.70|
71034361|NCT00796653|141578338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.049|STANDARD_ERROR_OF_MEAN|0.018||0.0071||95.0|0.013|0.085|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.085|0.013|0.0071
71034362|NCT00796653|141578339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.048|0.12|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.120|0.048|<0.0001
71034363|NCT00796653|141578339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.068|0.141|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.141|0.068|<0.0001
71095933|NCT03446573|141700287|OTHER||Mean Difference (Net)|0.0015||||0.792|TWO_SIDED|95.0|-0.0094|0.0123|||Mixed Model Repeated Measures||Week 48. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Utility (continuous), Treatment by Visit interaction, and Baseline EQ-5D Utility by Visit interaction, with Visit as the repeated factor.|||0.0123|-0.0094|0.792
70977237|NCT04258579|141462684|OTHER|Estimation only.|Mean value at 6 weeks, Domain 2|19.9|||||TWO_SIDED|95.0|18.0|21.8||||||||21.80|18.00|
70977238|NCT04258579|141462684|OTHER|Estimation only.|Mean value at 6 weeks, Domain 3|8.93|||||TWO_SIDED|95.0|7.68|10.18||||||||10.18|7.68|
70977239|NCT04258579|141462684|OTHER|Estimation only.|Mean value at 6 weeks, Domain 4|26.63|||||TWO_SIDED|95.0|24.32|28.94||||||||28.94|24.32|
70977240|NCT04258579|141462684|OTHER|Estimation only.|Mean value at 9 weeks, Domain 1|22.53|||||TWO_SIDED|95.0|19.87|25.23||||||||25.23|19.87|
70977241|NCT04258579|141462684|OTHER|Estimation only.|Mean value at 9 weeks, Domain 2|21.0|||||TWO_SIDED|95.0|18.87|23.13||||||||23.13|18.87|
70977242|NCT04258579|141462684|OTHER|Estimation only.|Mean value at 9 weeks, Domain 3|8.69|||||TWO_SIDED|95.0|7.39|9.99||||||||9.99|7.39|
70977243|NCT04258579|141462684|OTHER|Estimation only.|Mean value at 9 weeks, Domain 4|27.38|||||TWO_SIDED|95.0|25.07|29.69||||||||29.69|25.07|
71095934|NCT03446573|141700288|OTHER||Mean Difference (Net)|0.0003||||0.965|TWO_SIDED|95.0|-0.0121|0.0126|||Mixed Model Repeated Measures||Week 96. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Utility (continuous), Treatment by Visit interaction, and Baseline EQ-5D Utility by Visit interaction, with Visit as the repeated factor.|||0.0126|-0.0121|0.965
70977244|NCT04258579|141462684|OTHER|Estimation only.|Mean value at 12 weeks, Domain 1|22.62|||||TWO_SIDED|95.0|20.18|25.06||||||||25.06|20.18|
70977245|NCT04258579|141462684|OTHER|Estimation only.|Mean value at 12 weeks, Domain 2|21.58|||||TWO_SIDED|95.0|19.84|23.32||||||||23.32|19.84|
70977246|NCT04258579|141462684|OTHER|Estimation only.|Mean value at 12 weeks, Domain 3|9.19|||||TWO_SIDED|95.0|7.92|10.46||||||||10.46|7.92|
70977247|NCT04258579|141462684|OTHER|Estimation only.|Mean value at 12 weeks, Domain 4|27.81|||||TWO_SIDED|95.0|25.53|30.09||||||||30.09|25.53|
70977248|NCT04258579|141462685|OTHER|Estimation only.|Mean value at baseline|22.45|||||TWO_SIDED|95.0|19.56|25.34||||||||25.34|19.56|
70977249|NCT04258579|141462685|OTHER|Estimation only.|Mean value at 6 weeks|20.53|||||TWO_SIDED|95.0|17.65|23.41||||||||23.41|17.65|
70977250|NCT04258579|141462686|OTHER|Estimation only.|Mean value at baseline, Domain 1|19.89|||||TWO_SIDED|95.0|17.24|22.54||||||||22.54|17.24|
70977251|NCT04258579|141462686|OTHER|Estimation only.|Mean value at baseline, Domain 2|22.46|||||TWO_SIDED|95.0|19.72|25.2||||||||25.20|19.72|
70977252|NCT04258579|141462686|OTHER|Estimation only.|Mean value at baseline, Domain 3|16.0|||||TWO_SIDED|95.0|13.72|18.28||||||||18.28|13.72|
70977253|NCT04258579|141462686|OTHER|Estimation only.|Mean value at baseline, Domain 4|17.79|||||TWO_SIDED|95.0|15.34|20.24||||||||20.24|15.34|
70977254|NCT04258579|141462686|OTHER|Estimation only.|Mean value at 6 weeks, Domain 1|22.79|||||TWO_SIDED|95.0|19.05|26.53||||||||26.53|19.05|
70977255|NCT04258579|141462686|OTHER|Estimation only.|Mean value at 6 weeks, Domain 2|26.7|||||TWO_SIDED|95.0|22.96|30.44||||||||30.44|22.96|
70977256|NCT04258579|141462686|OTHER|Estimation only.|Mean value at 6 weeks, Domain 3|17.45|||||TWO_SIDED|95.0|14.57|20.33||||||||20.33|14.57|
70977257|NCT04258579|141462686|OTHER|Estimation only.|Mean value at 6 weeks, Domain 4|20.69|||||TWO_SIDED|95.0|18.23|23.15||||||||23.15|18.23|
70977258|NCT02076165|141462687|SUPERIORITY||||||=|0.12|||||||Fisher Exact|||Percentage of participants who completed all 5 treatment sessions, comparing ABC-I to CBT-I.||||=.120
70977259|NCT02076165|141462688|SUPERIORITY||Mean Difference (Final Values)|-0.711|STANDARD_ERROR_OF_MEAN|3.59|=|0.843|TWO_SIDED|95.0|-7.75|6.32|||Mixed Models Analysis||The average deviation, in minutes, between the recommended and actual bed time. Negative values indicate the number of minutes earlier than the recommended bed time that the participant went to bed, indicating greater non-adherence.|||6.32|-7.75|=.843
70977260|NCT02076165|141462689|SUPERIORITY||Mean Difference (Final Values)|-2.78|STANDARD_ERROR_OF_MEAN|5.17|=|0.59|TWO_SIDED|95.0|-12.91|7.35|||Mixed Models Analysis||The average deviation, in minutes, between the recommended and actual rise time. Positive values indicate the number of minutes later than the recommended rise time that the participant got out of bed, indicating greater non-adherence.|||7.35|-12.91|=0.590
70977261|NCT02076165|141462690|SUPERIORITY||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.048|=|0.979|TWO_SIDED|95.0|-0.093|0.096|||Mixed Models Analysis||The proportion of nights participants who did not follow the recommendation to get out of bed if awake more than 20 minutes. Higher numbers indicate greater non-adherence.|||0.096|-0.093|=0.979
70977262|NCT02076165|141462691|NON_INFERIORITY|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). For sleep diary estimated sleep efficiency, this represents a difference of 5%.|Mean Difference (Net)|0.409|STANDARD_ERROR_OF_MEAN|2.02|=|0.004|TWO_SIDED|90.0|-2.92|3.74|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency from baseline to post-treatment for ABCI group versus the same improvement in the CBTI group.|||3.74|-2.92|=0.004
70977263|NCT02076165|141462692|NON_INFERIORITY|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). For sleep diary estimated sleep efficiency, this represents a difference of 5%.|Mean Difference (Net)|0.757|STANDARD_ERROR_OF_MEAN|2.12||0.003|TWO_SIDED|90.0|-2.72|4.23|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency from baseline to 3-month follow-up for ABCI group versus the same improvement in the CBTI group.|||4.23|-2.72|.003
70977264|NCT02076165|141462693|NON_INFERIORITY|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). For actigraphically-estimated sleep efficiency, this represents a difference of 5%.|Mean Difference (Net)|0.68|STANDARD_ERROR_OF_MEAN|1.15|<|0.001|TWO_SIDED|90.0|-1.21|2.57|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency from baseline to post-treatment for ABCI group versus the same improvement in the CBTI group.|||2.57|-1.21|<0.001
70977265|NCT02076165|141462694|NON_INFERIORITY|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). For actigraphically-estimated sleep efficiency, this represents a difference of 5%.|Mean Difference (Net)|1.11|STANDARD_ERROR_OF_MEAN|1.37|<|0.001|TWO_SIDED|90.0|-1.14|3.36|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency from baseline to 3-month follow-up for ABCI group versus the same improvement in the CBTI group.|||3.36|-1.14|<.001
70977266|NCT02076165|141462695|NON_INFERIORITY|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). With respect to ISI, this represents a 2 point difference between the treatment effects.|Mean Difference (Net)|0.501|STANDARD_ERROR_OF_MEAN|0.9|=|0.048|TWO_SIDED|90.0|-0.98|1.98|||Mixed Models Analysis||The parameter estimate is the improvement in the ISI score from baseline to post-treatment for ABCI group versus the same improvement in the CBTI group.|||1.98|-0.98|=0.048
70977267|NCT02076165|141462696|NON_INFERIORITY|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). With respect to ISI, this represents a 2 point difference between the treatment effects.|Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|1.06|=|0.008|TWO_SIDED|90.0|-2.32|1.17|||Mixed Models Analysis||The parameter estimate is the improvement in the ISI score from baseline to 3-month follow-up for ABCI group versus the same improvement in the CBTI group.|||1.17|-2.32|=0.008
70977268|NCT01950819|141462715|NON_INFERIORITY|p vale for non inferiority margin is 10 %|Odds Ratio (OR)|3.0||||0.001|TWO_SIDED|95.0|-1.4|7.3|||Logistic Regression Model|||calculated at month 12||7.3|-1.4|0.001
70977269|NCT01756456|141462757|SUPERIORITY|Each of the comparisons was conducted on the data for the Phase II segment of the study using a 2 × 2 chi-square test, based on the null hypothesis that there is no association between treatment (rhNGF or Vehicle Control) and response (Complete Healing at Week 4 \[Yes/No\]).|Difference in percentage|35.3|||<|0.001|TWO_SIDED|97.06|15.88|54.71|||Chi-squared|||Phase II||54.71|15.88|<0.001
70977270|NCT01756456|141462757|SUPERIORITY|Each of the comparisons was conducted on the data for the Phase II segment of the study using a 2 × 2 chi-square test, based on the null hypothesis that there is no association between treatment (rhNGF or Vehicle Control) and response (Complete Healing at Week 4 \[Yes/No\]).|Difference in percentage|38.4|||=|0.001|TWO_SIDED|97.06|18.96|57.83|||Chi-squared|||||57.83|18.96|=0.001
70977271|NCT01756456|141462758|SUPERIORITY||Difference in percentage|25.8|||=|0.016|TWO_SIDED|97.06|3.66|47.87|||Chi-squared|||||47.87|3.66|=0.016
70977272|NCT01756456|141462758|SUPERIORITY||Difference in percentage|34.7|||=|0.002|TWO_SIDED|97.06|11.91|57.41|||Chi-squared|||||57.41|11.91|=0.002
70977273|NCT01756456|141462759|SUPERIORITY||difference in percentage|2.4|||=|0.818|TWO_SIDED|97.06|-20.3|25.08|||Chi-squared|||At week 6 - reading center||25.08|-20.30|=0.818
70977274|NCT01756456|141462759|SUPERIORITY||difference in percentage|-6.3|||=|0.571|TWO_SIDED|97.06|-30.62|17.96|||Chi-squared|||at week 6 - central reading center||17.96|-30.62|=0.571
70977275|NCT01756456|141462759|SUPERIORITY||Difference in percentage|20.3|||=|0.064|TWO_SIDED|97.06|-3.11|43.79|||Chi-squared|||week 6 - investigator||43.79|-3.11|=0.064
70977276|NCT01756456|141462759|SUPERIORITY||Difference in percentage|23.1|||=|0.041|TWO_SIDED|97.06|-0.89|47.04|||Chi-squared|||week 6 - investigator||47.04|-0.89|=0.041
70977277|NCT01756456|141462759|SUPERIORITY||Difference in percentage|21.9|||=|0.031|TWO_SIDED|97.06|0.07|43.64|||Chi-squared|||week 8 - central reading center||43.64|0.07|=0.031
70977278|NCT01756456|141462759|SUPERIORITY||difference in percentage|26.9|||=|0.008|TWO_SIDED|97.06|5.57|48.28|||Chi-squared|||week 8 - central reading center||48.28|5.57|=0.008
70977279|NCT01756456|141462759|SUPERIORITY||Difference in percentage|26.1|||=|0.011|TWO_SIDED|97.06|4.18|48.01|||Chi-squared|||week 8 - investigator||48.01|4.18|=0.011
70977280|NCT01756456|141462759|SUPERIORITY||Difference in percentage|25.9|||=|0.014|TWO_SIDED|97.06|3.55|48.33|||Chi-squared|||week 8 - investigator||48.33|3.55|=0.014
70922266|NCT02058108|141335142|OTHER||Mean Difference (Net)|2.5||||1|TWO_SIDED|95.0|-37.05|41.83|||Fisher Exact||Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.|Treatment emergent genotypic resistance at Week 24||41.83|-37.05|1.0000
70922267|NCT01619410|141335207|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
70922268|NCT04110054|141335230|EQUIVALENCE|Placebo (N = 102) vs S-600918 50 mg, 150 mg, 300 mg||||||0.9334||||||P-value was evaluated at the 2-sided alpha level of 0.05.|ANCOVA|||The null hypotheses of equality between the treatment and placebo effects were tested using a mixed model, containing treatment group, week, and interaction between treatment groups and week as fixed effects; participant as random effect; and region and the common logarithm of the frequency of coughs per hour at baseline as covariates. Covariance structure was given as unstructured.||||0.9334
70922269|NCT02885636|141335349|SUPERIORITY|||||||0.003|||||||ANCOVA|||||||0.003
70922270|NCT02885636|141335350|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.3
70922271|NCT02885636|141335351|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.7
70922272|NCT02885636|141335352|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||||||0.9
70922273|NCT02885636|141335353|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
70922274|NCT02885636|141335354|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.2
70922275|NCT02885636|141335355|SUPERIORITY|||||||0.0002|||||||t-test, 2 sided|||||||0.0002
70922276|NCT02885636|141335356|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
70922277|NCT02885636|141335357|SUPERIORITY|||||||0.0007|||||||t-test, 2 sided|||||||0.0007
70922278|NCT02885636|141335358|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
70922279|NCT02885636|141335359|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
70922280|NCT02885636|141335360|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.7
70922281|NCT02885636|141335361|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
70977281|NCT01756456|141462760|SUPERIORITY||difference in percentage|13.7|||=|0.065|TWO_SIDED|95.0|-0.19|27.57|||Chi-squared|||week 4||27.57|-0.19|=0.065
70922282|NCT02885636|141335362|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
70922283|NCT01340066|141335433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.92|ONE_SIDED|80.0|||||Chi-squared|||||||.92
70922284|NCT02395978|141335438|SUPERIORITY|||||||0.393|||||||Kruskal-Wallis|||||||0.393
70922285|NCT01172418|141335458|SUPERIORITY|||||||0.78|||||||Log Rank|||||||0.78
70922286|NCT01172418|141335459|SUPERIORITY|||||||0.37|||||||Log Rank|||||||0.37
70922287|NCT01172418|141335460|SUPERIORITY|||||||0.99|||||||Log Rank|||||||0.99
70922288|NCT01172418|141335461|SUPERIORITY|||||||0.25|||||||Log Rank|||||||0.25
70922289|NCT02538341|141335478|OTHER|||||||0.0023||||||p values, from a generalized linear model on the rank order of the week 6 - baseline change using normal distribution and reciprocal link.|a generalized linear model|p value,from a generalized linear model on the rank order of the week 6 - baseline change using normal distribution and reciprocal link.||Study protocol defined measure for immunogenicity samples. Participants must have at least 1 post vaccine immunogenicity measure to determine the GMFR (a priori analysis)||||0.0023
70922290|NCT02538341|141335479|OTHER|||||||0.31||||||p values, from a generalized linear model on the rank order of the week 6 - baseline change using normal distribution and reciprocal link.|a generalized linear model|p values, from a generalized linear model on the rank order of the week 6 - baseline change using normal distribution and reciprocal link.||Study protocol defined measure for immunogenicity samples. Participants must have at least 1 post vaccine immunogenicity measure to determine the GMFR (a priori analysis)||||0.31
70922291|NCT01227265|141335578|SUPERIORITY_OR_OTHER||Difference in Estimated Means|-0.2||||0.4933|TWO_SIDED|95.0|-0.72|0.35|||cLDA|||||0.35|-0.72|0.4933
70922292|NCT01227265|141335578|SUPERIORITY_OR_OTHER||Difference in Estimated Means|-0.3||||0.2364|TWO_SIDED|95.0|-0.86|0.21|||cLDA|||||0.21|-0.86|0.2364
70922293|NCT01227265|141335579|SUPERIORITY_OR_OTHER||Estimated Difference in Percentage|7.0||||0.244|TWO_SIDED|95.0|-4.17|18.05||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline average OFF time (hours/day) as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|Mixed Models Analysis|||||18.05|-4.17|0.244
70922294|NCT01227265|141335579|SUPERIORITY_OR_OTHER||Estimated Difference in Percentage|6.5||||0.262|TWO_SIDED|95.0|-4.63|17.61||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline average OFF time (hours/day) as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|Mixed Models Analysis|||||17.61|-4.63|0.262
70922295|NCT01227265|141335580|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.1||||0.776|TWO_SIDED|95.0|-0.47|0.63|||cLDA|||||0.63|-0.47|0.776
70922296|NCT01227265|141335580|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.1||||0.683|TWO_SIDED|95.0|-0.44|0.67|||cLDA|||||0.67|-0.44|0.683
70922297|NCT01227265|141335584|SUPERIORITY_OR_OTHER||Difference in Estimated Means|-0.2||||0.6968|TWO_SIDED|95.0|-0.92|0.61|||cLDA|||||0.61|-0.92|0.6968
70922298|NCT01227265|141335584|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.2||||0.6142|TWO_SIDED|95.0|-0.57|0.97|||cLDA|||||0.97|-0.57|0.6142
70922299|NCT03690206|141335587|SUPERIORITY||Difference to Placebo|-2.28||||0.0039|TWO_SIDED|95.0|-3.83|-0.73|||Mixed Models Analysis|||||-0.73|-3.83|0.0039
70922300|NCT03690206|141335587|SUPERIORITY||Difference to Placebo|-0.91||||0.27|TWO_SIDED|95.0|-2.52|0.71|||Mixed Models Analysis|||||0.71|-2.52|0.2700
70922301|NCT03690206|141335588|SUPERIORITY||Difference to Placebo|26.6||||0.0243|TWO_SIDED|95.0|4.3|48.9|||Cochran-Mantel-Haenszel|||||48.9|4.3|0.0243
70922302|NCT03690206|141335588|SUPERIORITY||Difference to Placebo|5.5||||0.6255|TWO_SIDED|95.0|-16.2|27.1|||Cochran-Mantel-Haenszel|||||27.1|-16.2|0.6255
70922303|NCT03690206|141335589|SUPERIORITY||Difference to Placebo|31.7||||0.0043|TWO_SIDED|95.0|11.4|51.9|||Cochran-Mantel-Haenszel|||||51.9|11.4|0.0043
70922304|NCT03690206|141335589|SUPERIORITY||Difference to Placebo|13.3||||0.1675|TWO_SIDED|95.0|-5.4|32.0|||Cochran-Mantel-Haenszel|||||32.0|-5.4|0.1675
70922305|NCT03690206|141335591|SUPERIORITY||Difference to Placebo|14.1||||0.016|TWO_SIDED|95.0|2.5|25.6|||Cochran-Mantel-Haenszel|||||25.6|2.5|0.0160
70922306|NCT03690206|141335591|SUPERIORITY||Difference to Placebo|11.2||||0.0424|TWO_SIDED|95.0|0.7|21.6|||Cochran-Mantel-Haenszel|||||21.6|0.7|0.0424
70977282|NCT01756456|141462760|SUPERIORITY||difference in percentage|12.4|||=|0.097|TWO_SIDED|95.0|-2.05|26.78|||Chi-squared|||week 4||26.78|-2.05|=0.097
70977283|NCT01756456|141462760|SUPERIORITY||difference in percentage|16.9|||=|0.036|TWO_SIDED|95.0|1.97|31.92|||Chi-squared|||week 6||31.92|1.97|=0.036
70977284|NCT01756456|141462760|SUPERIORITY||difference in percentage|15.6|||=|0.054|TWO_SIDED|95.0|0.04|31.12|||Chi-squared|||week 6||31.12|0.04|=0.054
70977285|NCT01756456|141462760|SUPERIORITY||difference in percentage|17.1|||=|0.043|TWO_SIDED|95.0|1.45|32.72|||Chi-squared|||week 8||32.72|1.45|=0.043
70977286|NCT01756456|141462760|SUPERIORITY||difference in percentage|11.4|||=|0.157|TWO_SIDED|95.0|-4.08|26.93|||Chi-squared|||week 8||26.93|-4.08|=0.157
70977287|NCT01756456|141462761|SUPERIORITY||least square mean difference|8.9|||=|0.022|TWO_SIDED|95.0|1.33|16.5|||ANCOVA|||||16.50|1.33|=0.022
70977288|NCT01756456|141462761|SUPERIORITY||least square mean difference|5.0|||=|0.213|TWO_SIDED|95.0|-2.9|12.88|||ANCOVA|||||12.88|-2.90|=0.213
70977289|NCT01756456|141462762|SUPERIORITY||difference in percentage|5.5|||=|0.592|TWO_SIDED|95.0|-14.53|25.48|||Chi-squared|||week 4||25.48|-14.53|=0.592
70977290|NCT01756456|141462762|SUPERIORITY|week 4|difference in percentage|-2.3|||=|0.835|TWO_SIDED|95.0|-24.01|19.4|||Chi-squared|||||19.40|-24.01|=0.835
70977291|NCT01756456|141462762|SUPERIORITY||difference in percentage|27.7|||=|0.008|TWO_SIDED|95.0|8.1|47.22|||Chi-squared|||week 6||47.22|8.10|=0.008
70977292|NCT01756456|141462762|SUPERIORITY||difference in percentage|12.4|||=|0.282|TWO_SIDED|95.0|-9.91|34.68|||Chi-squared|||week 6||34.68|-9.91|=0.282
70977293|NCT01756456|141462762|SUPERIORITY||difference in percentage|10.2|||=|0.303|TWO_SIDED|95.0|-9.15|29.45|||Chi-squared|||||29.45|-9.15|=0.303
70977294|NCT01756456|141462762|SUPERIORITY||difference in percentage|7.9|||=|0.442|TWO_SIDED|95.0|-12.13|27.92|||Chi-squared|||week 8||27.92|-12.13|=0.442
70977295|NCT01756456|141462763|SUPERIORITY||difference in percentage|-2.6|||=|0.597|TWO_SIDED|95.0|-22.87|17.71|||Chi-squared|||week 4||17.71|-22.87|=0.597
70977296|NCT01756456|141462763|SUPERIORITY||difference in percentage|-2.3|||>|0.999|TWO_SIDED|95.0|-23.26|18.71|||Chi-squared|||week 4||18.71|-23.26|>0.999
71034364|NCT00796653|141578339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.018||0.0001||95.0|0.034|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.106|0.034|0.0001
70977297|NCT01756456|141462763|SUPERIORITY||difference in percentage|-7.8|||=|0.183|TWO_SIDED|95.0|-28.7|13.76|||Chi-squared|||week 6||13.76|-28.70|=0.183
70977298|NCT01756456|141462763|SUPERIORITY||difference in percentage|-10.0|||=|0.116|TWO_SIDED|95.0|-31.41|11.88|||Chi-squared|||week 6||11.88|-31.41|=0.116
70977299|NCT01756456|141462763|SUPERIORITY||difference in percentage|-10.8|||=|0.134|TWO_SIDED|95.0|-31.3|10.35|||Chi-squared|||week 8||10.35|-31.30|=0.134
70977300|NCT01756456|141462763|SUPERIORITY||difference in percentage|-7.9|||=|0.307|TWO_SIDED|95.0|-29.51|13.52|||Chi-squared|||week 8||13.52|-29.51|=0.307
70977301|NCT01756456|141462765|SUPERIORITY||Odds Ratio (OR)|2.18|||=|0.041|TWO_SIDED|95.0|1.03|4.62|||Chi-squared|||week 4||4.62|1.03|=0.041
70977302|NCT01756456|141462765|SUPERIORITY||Odds Ratio (OR)|1.95|||=|0.081|TWO_SIDED|95.0|0.92|4.11|||Chi-squared|||week 4||4.11|0.92|=0.081
70977303|NCT01756456|141462765|SUPERIORITY||Odds Ratio (OR)|2.47|||=|0.04|TWO_SIDED|95.0|1.04|5.88|||Chi-squared|||week 8||5.88|1.04|=0.040
70977304|NCT01756456|141462765|SUPERIORITY||Odds Ratio (OR)|1.93|||=|0.132|TWO_SIDED|95.0|0.82|4.52|||Chi-squared|||week 8||4.52|0.82|=0.132
70977305|NCT01756456|141462770|SUPERIORITY||difference in percentage|15.8|||=|0.097|TWO_SIDED|95.0|-2.36|33.97|||Chi-squared|||week 4||33.97|-2.36|=0.097
70977306|NCT01756456|141462770|SUPERIORITY||difference in percentage|13.2|||=|0.175|TWO_SIDED|95.0|-5.72|32.15|||Chi-squared|||week 4||32.15|-5.72|=0.175
70977307|NCT01756456|141462770|SUPERIORITY||difference in percentage|16.9|||=|0.105|TWO_SIDED|95.0|-3.11|37.0|||Chi-squared|||week 6||37.00|-3.11|=0.105
70977308|NCT01756456|141462770|SUPERIORITY||difference in percentage|11.0|||=|0.3|TWO_SIDED|95.0|-9.64|31.57|||Chi-squared|||week 6||31.57|-9.64|=0.300
70977309|NCT01756456|141462770|SUPERIORITY||difference in percentage|27.5|||=|0.008|TWO_SIDED|95.0|8.33|46.67|||Chi-squared|||week 8||46.67|8.33|=0.008
70977310|NCT01756456|141462770|SUPERIORITY||difference in percentage|19.0|||=|0.068|TWO_SIDED|95.0|-0.91|38.83|||Chi-squared|||week 8||38.83|-0.91|=0.068
70977311|NCT01649947|141462773|OTHER||Mean Difference (Net)|56.0||||0.01|TWO_SIDED|95.0|8.9|72.0|||t-test, 2 sided|||The analysis is comprised of evaluable patients who had measureable disease and received at least one cycle of therapy and had disease evaluated.||72|8.9|0.01
70977312|NCT01850615|141462794|SUPERIORITY_OR_OTHER||Treatment difference|-0.94|||||TWO_SIDED|95.0|-1.17|-0.72|||||Superiority was considered confirmed if the upper bound of the two-sided 95% confidence interval (CI) for the estimated treatment difference (faster aspart+basal minus basal only), which was calculated using the FAS, was below 0%.|Change from baseline in HbA1c after 18 weeks of treatment was analysed using a mixed-effect model for repeated measurements (MMRM) where all calculated changes in HbA1c from baseline at visits 16, 22 and 28 were included in the analysis. This model included treatment, region and strata as fixed factors, subject as random effect, baseline HbA1c as covariate and interaction between all fixed effects and visit, and between the covariate and visit.||-0.72|-1.17|
70977313|NCT01227967|141462800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.0|STANDARD_ERROR_OF_MEAN|5.0||0.046|TWO_SIDED|95.0|-19.8|-0.2||P-value was not adjusted for multiple interim analyses.|Z-test, 2-sided|Comparison of randomized arms was based on the normal approximation to the binomial distribution.|The difference in percents was calculated as the percent detectable in the Combination Therapy minus the percent detectable in the Oseltamivir Monotherapy.|Assuming that pooled percentage of participants with virus detectable by PCR at Day 3 is 50%, assuming that the Combination Therapy was better than the Oseltamivir Monotherapy and that the detectable rate in the Combination Therapy was 42.5% compared to 57.5% in the Oseltamivir Monotherapy (a 15% reduction), and assuming 10% subjects with missing qPCR at Day 3, in a two-sided, two-sample 0.05-level t- test with 546 participants combined across both arms, there was 90% power.||-0.2|-19.8|0.046
70977314|NCT01763164|141462815|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.001|TWO_SIDED|95.0|0.47|0.8|||Log Rank|||Hazard ratio was obtained from the stratified unadjusted Cox model. P-value was obtained from the one-sided stratified log-rank test.||0.80|0.47|< 0.001
70977315|NCT01763164|141462816|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.499|TWO_SIDED|95.0|0.75|1.33|||Log Rank|||Hazard ratio was obtained from the stratified unadjusted Cox model. P-value was obtained from the one-sided stratified log rank test.||1.33|0.75|0.499
70977316|NCT01763164|141462817|SUPERIORITY|||||||0.015|||||||Cochran-Mantel-Haenszel|||Confirmed ORR: The p-value (2-sided) was computed from stratified Cochran-Mantel-Haenszel chi-square test statistic.||||0.015
70977317|NCT01763164|141462817|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|||Confirmed ORR + Unconfirmed ORR: The p-value (2-sided) was computed from stratified Cochran-Mantel-Haenszel chi-square test statistic.||||0.002
70977318|NCT01763164|141462830|SUPERIORITY||Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|0.96|2.13|||Log Rank|||||2.13|0.96|
70977319|NCT01763164|141462833|SUPERIORITY||Hazard Ratio (HR)|2.2||||0.995|TWO_SIDED|95.0|1.19|4.06|||Log Rank|||Log-rank test and Cox PH model were stratified by American joint committee on cancer stage, prior line immunotherapy and ECOG performance status. P-value was one tailed and was based on the log-rank score test. Hazard ratio and 95% CI was based on a Wald test from Cox model.||4.06|1.19|0.995
70977320|NCT01375764|141462856|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.94|STANDARD_ERROR_OF_MEAN|4.11|<|0.001|TWO_SIDED|95.0|-44.08|-27.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-27.80|-44.08|<0.001
70977321|NCT01375764|141462856|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.82|STANDARD_ERROR_OF_MEAN|4.12|<|0.001|TWO_SIDED|95.0|-35.97|-19.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-19.67|-35.97|<0.001
70977322|NCT01375764|141462856|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Tretament Difference|-26.01|STANDARD_ERROR_OF_MEAN|4.08|<|0.001|TWO_SIDED|95.0|-34.08|-17.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-17.93|-34.08|<0.001
70977323|NCT01375764|141462857|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.29|STANDARD_ERROR_OF_MEAN|3.22|<|0.001|TWO_SIDED|95.0|-53.73|-40.84||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab + ezetimibe and ezetimibe alone, and the alternative hypothesis was that a mean difference did exist.||-40.84|-53.73|<0.001
70977324|NCT01375764|141462858|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-76.6|STANDARD_ERROR_OF_MEAN|9.2|<|0.001|TWO_SIDED|95.0|-94.9|-58.3||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-58.3|-94.9|<0.001
70977325|NCT01375764|141462858|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.5|STANDARD_ERROR_OF_MEAN|9.3|<|0.001|TWO_SIDED|95.0|-74.0|-37.1||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-37.1|-74.0|<0.001
70977326|NCT01375764|141462858|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.6|STANDARD_ERROR_OF_MEAN|9.2|<|0.001|TWO_SIDED|95.0|-70.8|-34.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-34.5|-70.8|<0.001
70977327|NCT01375764|141462859|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-91.9|STANDARD_ERROR_OF_MEAN|8.4|<|1|TWO_SIDED|95.0|-108.7|-75.0||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.|||-75.0|-108.7|<0001
70977328|NCT01375764|141462860|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.6|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-40.93|-26.28||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-26.28|-40.93|<0.001
70977329|NCT01375764|141462860|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.66|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-33.99|-19.32||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-19.32|-33.99|<0.001
71034365|NCT00796653|141578340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.019||0.0017||95.0|0.022|0.095|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.095|0.022|0.0017
70977330|NCT01375764|141462860|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-24.86|STANDARD_ERROR_OF_MEAN|3.67|<|0.001|TWO_SIDED|95.0|-32.13|-17.59||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-17.59|-32.13|<0.001
70977331|NCT01375764|141462861|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.0|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|-50.81|-39.18||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.|||-39.18|-50.81|<0.001
70977332|NCT01375764|141462862|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Teatment Difference|-29.88|STANDARD_ERROR_OF_MEAN|3.52|<|0.001|TWO_SIDED|95.0|-36.84|-22.92||Testing based on a significance level of 0.05|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-22.92|-36.84|<0.001
70977333|NCT01375764|141462862|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.13|STANDARD_ERROR_OF_MEAN|3.52|<|0.001|TWO_SIDED|95.0|-29.1|-15.16||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-15.16|-29.10|<0.001
70977334|NCT01375764|141462862|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-21.38|STANDARD_ERROR_OF_MEAN|3.49|<|0.001|TWO_SIDED|95.0|-28.29|-14.48||Testing based on a signficance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-14.48|-28.29|<0.001
70977335|NCT01375764|141462863|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.23|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-43.81|-32.64||Testing based on a significance level of 0.05|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.|||-32.64|-43.81|<0.001
70977336|NCT01375764|141462864|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-30.95|STANDARD_ERROR_OF_MEAN|3.34|<|0.001|TWO_SIDED|95.0|-37.56|-24.34||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-24.34|-37.56|<0.001
71034366|NCT00796653|141578340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.057|0.13|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.130|0.057|<0.0001
71034367|NCT00796653|141578340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.019||0.0005||95.0|0.028|0.101|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.101|0.028|0.0005
71034368|NCT00796653|141578341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.019||0.0085||95.0|0.013|0.087|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.087|0.013|0.0085
71034369|NCT00796653|141578341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.049|0.122|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.122|0.049|<0.0001
71034370|NCT00796653|141578341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.051|STANDARD_ERROR_OF_MEAN|0.019||0.0067||95.0|0.014|0.088|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.088|0.014|0.0067
71034371|NCT00796653|141578342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|STANDARD_ERROR_OF_MEAN|0.019||0.0012||95.0|0.025|0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.100|0.025|0.0012
71034372|NCT00796653|141578342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.019||0.0002||95.0|0.035|0.11|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.110|0.035|0.0002
71034373|NCT00796653|141578342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.019||0.0117||95.0|0.011|0.086|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.086|0.011|0.0117
71034374|NCT00796653|141578343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|STANDARD_ERROR_OF_MEAN|0.019||0.0014||95.0|0.024|0.099|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.099|0.024|0.0014
71095935|NCT03446573|141700288|OTHER||Mean Difference (Net)|-0.0109||||0.12|TWO_SIDED|95.0|-0.0247|0.0029|||Mixed Model Repeated Measures||Week 144. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Utility (continuous), Treatment by Visit interaction, and Baseline EQ-5D Utility by Visit interaction, with Visit as the repeated factor.|||0.0029|-0.0247|0.120
70977337|NCT01375764|141462864|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-23.91|STANDARD_ERROR_OF_MEAN|3.34|<|0.001|TWO_SIDED|95.0|-30.53|-17.29||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-17.29|-30.53|<0.001
70977338|NCT01375764|141462864|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.36|STANDARD_ERROR_OF_MEAN|3.31|<|0.001|TWO_SIDED|95.0|-28.92|-15.8||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-15.80|-28.92|<0.001
71095936|NCT03446573|141700289|OTHER||Mean Difference (Net)|-0.1||||0.879|TWO_SIDED|95.0|-1.4|1.2|||Mixed Model Repeated Measures||Week 24. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Thermometer (continuous), Treatment by Visit interaction, and Baseline EQ-5D Thermometer by Visit interaction, with Visit as the repeated factor.|||1.2|-1.4|0.879
71034375|NCT00796653|141578343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.047|0.122|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.122|0.047|<0.0001
71034376|NCT00796653|141578343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.019||0.0035||95.0|0.019|0.094|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.094|0.019|0.0035
71034377|NCT00796653|141578344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.019||0.0228||95.0|0.006|0.082|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.082|0.006|0.0228
71034378|NCT00796653|141578344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.019||0.0024||95.0|0.021|0.097|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.097|0.021|0.0024
71034379|NCT00796653|141578344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036|STANDARD_ERROR_OF_MEAN|0.019||0.0664||95.0|-0.002|0.074|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.074|-0.002|0.0664
71034380|NCT00796653|141578345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.122|0.199|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.199|0.122|<0.0001
71034381|NCT00796653|141578345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.14|0.216|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.216|0.140|<0.0001
71034382|NCT00796653|141578345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.153|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.115|0.191|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.191|0.115|<0.0001
71034383|NCT00796653|141578346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.168|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.13|0.207|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.207|0.130|<0.0001
71034384|NCT00796653|141578346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.181|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.143|0.22|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.220|0.143|<0.0001
71034385|NCT00796653|141578346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.137|0.214|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.214|0.137|<0.0001
71095937|NCT03446573|141700289|OTHER||Mean Difference (Net)|-0.5||||0.414|TWO_SIDED|95.0|-1.9|0.8|||Mixed Model Repeated Measures||Week 48. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Thermometer (continuous), Treatment by Visit interaction, and Baseline EQ-5D Thermometer by Visit interaction, with Visit as the repeated factor.|||0.8|-1.9|0.414
71034386|NCT00796653|141578347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.103|0.18|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.180|0.103|<0.0001
71034387|NCT00796653|141578347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.168|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.129|0.207|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.207|0.129|<0.0001
71034388|NCT00796653|141578347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.125|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.203|0.125|<0.0001
71034389|NCT00796653|141578348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.084|0.163|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.163|0.084|<0.0001
71034390|NCT00796653|141578348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.112|0.191|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.191|0.112|<0.0001
71095938|NCT03446573|141700290|OTHER||Mean Difference (Net)|-1.2||||0.102|TWO_SIDED|95.0|-2.5|0.2|||Mixed Model Repeated Measures||Week 96. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Thermometer (continuous), Treatment by Visit interaction, and Baseline EQ-5D Thermometer by Visit interaction, with Visit as the repeated factor.|||0.2|-2.5|0.102
71095939|NCT03446573|141700290|OTHER||Mean Difference (Net)|-1.3||||0.093|TWO_SIDED|95.0|-2.8|0.2|||Mixed Model Repeated Measures||Week 144. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Thermometer (continuous), Treatment by Visit interaction, and Baseline EQ-5D Thermometer by Visit interaction, with Visit as the repeated factor.|||0.2|-2.8|0.093
70922307|NCT05028582|141335601|SUPERIORITY||Odds Ratio, log|5.19|||<|0.0001|TWO_SIDED|97.5|2.9|9.31|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|S-IGA Success at Week 8||9.31|2.90|<0.0001
70977339|NCT01375764|141462865|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.92|STANDARD_ERROR_OF_MEAN|2.92|<|0.001|TWO_SIDED|95.0|-43.77|-32.07||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.|||-32.07|-43.77|<0.001
70977340|NCT01375764|141462866|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.05|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-40.57|-27.52||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-27.52|-40.57|<0.001
70977341|NCT01375764|141462866|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.81|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-33.35|-20.27||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-20.27|-33.35|<0.001
70922308|NCT05028582|141335602|SUPERIORITY||Odds Ratio (OR)|3.17|||<|0.0001|TWO_SIDED|97.5|1.75|5.73|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|B-IGA Success at Week 8||5.73|1.75|<0.0001
70922309|NCT05028582|141335603|OTHER|SI-NRS Success at Week 4|Odds Ratio (OR)|4.67||||0.0005|TWO_SIDED|97.5|1.6|13.62|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S IGA, and baseline B-IGA with multiple imputation to handle missing data|||13.62|1.60|0.0005
70922310|NCT05028582|141335604|SUPERIORITY||Odds Ratio (OR)|4.39|||<|0.0001|TWO_SIDED|97.5|2.01|9.55|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S IGA, and baseline B-IGA with multiple imputation to handle missing data|SI-NRS Success at Week 4||9.55|2.01|<0.0001
70977342|NCT01375764|141462866|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.1|STANDARD_ERROR_OF_MEAN|3.27|<|0.001|TWO_SIDED|95.0|-31.57|-18.62||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-18.62|-31.57|<0.001
70977343|NCT01375764|141462867|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.25|STANDARD_ERROR_OF_MEAN|2.87|<|0.001|TWO_SIDED|95.0|-46.99|-35.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.|||-35.50|-46.99|<0.001
70977344|NCT01512264|141462880|OTHER|||||||0.006|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the rTMS group and BNT test was calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -1.58.||||0.006
70977345|NCT01512264|141462880|OTHER|||||||0.015|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the1 week of Sham Treatment + 2 weeks of nerTMS group and BNT test was calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -1.27.||||0.015
70977346|NCT01512264|141462880|OTHER|||||||0.203|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 2 weeks of Sham Treatment + 1 week of nerTMS group and BNT test was calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.54.||||0.203
70977347|NCT01512264|141462880|OTHER|||||||0.01|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the control group and BNT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -1.63.||||0.010
70977348|NCT01512264|141462881|OTHER|||||||0.41|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the rTMS group and BNT test was calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.54.||||0.410
70977349|NCT01512264|141462881|OTHER|||||||0.618|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for 1 week of Sham Treatment + 2 weeks of nerTMS group and BNT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.57.||||0.618
70977350|NCT01512264|141462881|OTHER|||||||1|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for 2 weeks of Sham Treatment + 1 week of nerTMS group and BNT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 1.31.||||1.000
70977351|NCT01512264|141462881|OTHER|||||||0.019|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the control group and BNT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 4.35.||||0.019
70977352|NCT01512264|141462883|OTHER|||||||0.118|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the rTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.69.||||0.118
70977353|NCT01512264|141462883|OTHER|||||||0.482|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.28.||||0.482
70977354|NCT01512264|141462883|OTHER|||||||0.368|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 2 weeks of Sham Treatment +1 week of nerTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.37.||||0.368
70977355|NCT01512264|141462883|OTHER|||||||0.147|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the control group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.70.||||0.147
71095940|NCT05987540|141700292|SUPERIORITY|||||||0.8125|||||||Wilcoxon matched-pairs signed rank|||||||.8125
70977356|NCT01512264|141462884|OTHER|||||||0.41|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the rTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.54.||||0.410
70977357|NCT01512264|141462884|OTHER|||||||0.695|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.25.||||0.695
70977358|NCT01512264|141462884|OTHER|||||||0.175|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 2 weeks of Sham Treatment +1 week of nerTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.25.||||0.175
70977359|NCT01512264|141462884|OTHER|||||||0.518|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the control group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.60.||||0.518
70977360|NCT01512264|141462886|OTHER|||||||0.109|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the rTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.71.||||0.109
70977361|NCT01512264|141462886|OTHER|||||||0.485|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.28.||||0.485
70977362|NCT01512264|141462886|OTHER|||||||0.864|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 2 weeks of Sham Treatment +1 week of nerTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.07.||||0.864
70977363|NCT01512264|141462886|OTHER|||||||0.341|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the control group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.43.||||0.341
70977364|NCT01512264|141462887|OTHER|||||||0.899|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the rTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.12.||||0.899
70977365|NCT01512264|141462887|OTHER|||||||0.519|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.19.||||0.519
70977366|NCT01512264|141462887|OTHER|||||||1|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 2 weeks of Sham Treatment +1 week of nerTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.09.||||1.000
70977367|NCT01512264|141462887|OTHER|||||||0.14|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the control group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.84.||||0.140
70977368|NCT01512264|141462889|OTHER|||||||0.52|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the rTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.24.||||0.520
70977369|NCT01512264|141462889|OTHER|||||||0.8|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.97.||||0.800
70977370|NCT01512264|141462889|OTHER|||||||0.148|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 2 weeks of Sham Treatment +1 week of nerTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.68.||||0.148
70977371|NCT01512264|141462889|OTHER|||||||0.787|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the control group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.67.||||0.787
70977372|NCT01512264|141462890|OTHER|||||||0.239|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the rTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -3.12.||||0.239
70977373|NCT01512264|141462890|OTHER|||||||0.212|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 2.71.||||0.212
70977374|NCT01512264|141462890|OTHER|||||||0.12|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 2 weeks of Sham Treatment +1 week of nerTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -3.10.||||0.120
70977375|NCT01512264|141462890|OTHER|||||||0.263|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the control group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -1.14.||||0.263
70977376|NCT01194440|141462900|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Bonferonni|Adjusting for multiple comparisons in the analyses, a Bonferonni-corrected p-value of 0.05/5 = 0.01 to represent statistical significance was used.||The primary hypothesis of the study is that administration of zoledronic acid with letrozole would result in a significant decline in the percentage of women experiencing AIMSS compared to letrozole treatment alone (historical control).||||<0.001
70977377|NCT00584870|141462904|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) Mean Difference|-1.17|STANDARD_ERROR_OF_MEAN|0.39||0.001|TWO_SIDED|80.0|-1.67|-0.67||p-value was based on repeated measures model from pairwise comparisons, and statistical test was 1-sided with 0.1 significance level.|Repeated Measures Model|||LS mean difference was estimated from the repeated measures model with baseline, center, treatment, week and treatment-by-week interaction as fixed main effects and participant as random effect.||-0.67|-1.67|0.001
70977378|NCT00854828|141462926|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71095941|NCT05987540|141700295|SUPERIORITY||||||>|0.9999|||||||Wilconxon matched-pairs signed rank test|||||||>0.9999
70922311|NCT05028582|141335605|OTHER|SI-NRS Success at Week 8|Odds Ratio (OR)|5.41|||<|0.0001|TWO_SIDED|97.5|2.49|11.78|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S IGA, and baseline B-IGA with multiple imputation to handle missing data|||11.78|2.49|<0.0001
70922312|NCT05028582|141335606|SUPERIORITY|SI-NRS Change from Baseline Day 1|LS Mean Difference|-0.35||||0.0164|TWO_SIDED|97.5|-0.68|-0.02|||ANCOVA|ANCOVA terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline SI-NRS score|ANCOVA terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline SI-NRS score|||-0.02|-0.68|0.0164
70922313|NCT05028582|141335607|SUPERIORITY|SI-NRS Change from Baseline Day 1|LS Mean Difference|-0.76|||<|0.0001|TWO_SIDED|97.5|-1.12|-0.39|||ANCOVA|ANCOVA terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline SI-NRS score|ANCOVA terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline SI-NRS score|||-0.39|-1.12|<0.0001
70922314|NCT05028582|141335608|SUPERIORITY|Change from Baseline in Weekly SI-NRS at Week 1|LS Mean Difference|-0.55||||0.0002|TWO_SIDED|97.5|-0.87|-0.22|||ANCOVA|ANCOVA terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline SI-NRS score|ANCOVA terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline SI-NRS score|||-0.22|-0.87|0.0002
70922315|NCT05028582|141335609|OTHER|WI-NRS Success at Week 8|Odds Ratio (OR)|4.14|||<|0.0001|TWO_SIDED|97.5|2.01|8.52|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA|||8.52|2.01|<0.0001
70922316|NCT05028582|141335610|SUPERIORITY|PASI-75 at Week 8|Odds Ratio (OR)|5.42|||<|0.0001|TWO_SIDED|97.5|2.73|10.75|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||10.75|2.73|<0.0001
70922317|NCT05028582|141335611|SUPERIORITY|PSD Aggregate Score Change at Week 8|LS Mean Difference|-5.12|||<|0.0001|TWO_SIDED|97.5|-6.64|-3.6|||ANCOVA|Covariate terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA and baseline PSD aggregate score \& multiple imputation of missing data|Covariate terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA and baseline PSD aggregate score \& multiple imputation of missing data|||-3.60|-6.64|<0.0001
70922318|NCT05028582|141335612|SUPERIORITY|PSD Itching Week 8|Odds Ratio (OR)|4.59|||<|0.0001|TWO_SIDED|97.5|2.1|10.04|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||10.04|2.10|<0.0001
70922319|NCT05028582|141335613|SUPERIORITY|PSD Pain Week 8|Odds Ratio (OR)|3.23|||<|0.0001|TWO_SIDED|97.5|1.83|5.68|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||5.68|1.83|<0.0001
70922320|NCT05028582|141335614|SUPERIORITY|PSD Scaling Week 8|Odds Ratio (OR)|4.56|||<|0.0001|TWO_SIDED|97.5|2.28|9.08|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||9.08|2.28|<0.0001
70922321|NCT05028582|141335615|OTHER|PSD Total Score 0 at Week 8|Odds Ratio (OR)|3.27||||0.0012|TWO_SIDED|97.5|1.39|7.68|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA|||7.68|1.39|0.0012
70977379|NCT00896532|141462948|SUPERIORITY||LS Mean Difference from Placebo|8.7|||<|0.0001|TWO_SIDED|95.0|7.5|9.9||P-value is adjusted by the Hochberg procedure for comparisons to placebo.|Linear Mixed Effects Model|||A linear mixed effects model was fit with the percent change from baseline to months 3, 6 and 12 in BMD of the lumbar spine as the dependent variable and baseline BMD, machine type, interaction of baseline BMD and machine type, geographic region (Latin America, North America, Europe), visit, treatment regimen (categorical), interaction of treatment regimen and visit as the independent variables.||9.9|7.5|< 0.0001
70977380|NCT00896532|141462948|SUPERIORITY||LS Mean Difference from placebo|5.6|||<|0.0001|TWO_SIDED|95.0|4.3|6.9||P-value is adjusted by the Hochberg procedure for comparisons to placebo.|Linear Mixed Effects Model|||A linear mixed effects model was fit with the percent change from baseline to months 3, 6 and 12 in BMD of the lumbar spine as the dependent variable and baseline BMD, machine type, interaction of baseline BMD and machine type, geographic region (Latin America, North America, Europe), visit, treatment regimen (categorical), interaction of treatment regimen and visit as the independent variables.||6.9|4.3|< 0.0001
71034391|NCT00796653|141578348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.104|0.183|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.183|0.104|<0.0001
70922322|NCT05028582|141335616|SUPERIORITY|PSSI-75 at Week 8|Odds Ratio (OR)|5.4|||<|0.0001|TWO_SIDED|97.5|2.98|9.77|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S IGA, and baseline B IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S IGA, and baseline B IGA with multiple imputation to handle missing data|||9.77|2.98|<0.0001
70922323|NCT05028582|141335617|SUPERIORITY|S-IGA Clear at Week 8|Odds Ratio (OR)|6.77|||<|0.0001|TWO_SIDED|97.5|3.04|15.05|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||15.05|3.04|<0.0001
70922324|NCT05028582|141335618|SUPERIORITY|S-IGA Success Week 2|Odds Ratio (OR)|4.1|||<|0.0001|TWO_SIDED|97.5|1.84|9.13|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||9.13|1.84|<0.0001
70922325|NCT05028582|141335619|SUPERIORITY|S-IGA Success at Week 4|Odds Ratio (OR)|4.82|||<|0.0001|TWO_SIDED|97.5|2.62|8.84|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||8.84|2.62|<0.0001
70977381|NCT00896532|141462948|SUPERIORITY||LS Mean Difference from Placebo|7.4|||<|0.0001|TWO_SIDED|95.0|6.1|8.7||P-value is adjusted by the Hochberg procedure for comparisons to placebo.|Linear Mixed Effects Model|||A linear mixed effects model was fit with the percent change from baseline to months 3, 6 and 12 in BMD of the lumbar spine as the dependent variable and baseline BMD, machine type, interaction of baseline BMD and machine type, geographic region (Latin America, North America, Europe), visit, treatment regimen (categorical), interaction of treatment regimen and visit as the independent variables.||8.7|6.1|< 0.0001
70977382|NCT00896532|141462948|SUPERIORITY||LS Mean Difference from Placebo|8.5|||<|0.0001|TWO_SIDED|95.0|7.3|9.8||P-value is adjusted by the Hochberg procedure for comparisons to placebo.|Linear Mixed Effects Model|||A linear mixed effects model was fit with the percent change from baseline to months 3, 6 and 12 in BMD of the lumbar spine as the dependent variable and baseline BMD, machine type, interaction of baseline BMD and machine type, geographic region (Latin America, North America, Europe), visit, treatment regimen (categorical), interaction of treatment regimen and visit as the independent variables.||9.8|7.3|< 0.0001
70977383|NCT02411747|141462959|NON_INFERIORITY_OR_EQUIVALENCE|Beta: 0.8, p significant if p \> 0.005||||||0.34|||||||t-test, 2 sided|||Independent samples t-test||||0.34
70977384|NCT02149810|141462960|SUPERIORITY||Mean Difference (Net)|0.109||||0.28|TWO_SIDED|95.0|-0.09|0.31||The a priori threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Linear mixed models, controlling for baseline score, were used to compare the SSM and TAU groups' change score from baseline to 12-week on SDNN.||The primary focus of this study was the interaction effect of treatment on heart rate variability at Weeks 0 and 12. On the assumption that this effect size is medium (Cohen's f = .25), calculations (using G\*Power) 23 indicate that a sample size of 80 yield power estimates of .99 for both the interaction and the main effect of time. The study enrolled 95 participants to account for participant attrition.||0.31|-0.09|0.28
70977385|NCT02149810|141462961|SUPERIORITY||Mean Difference (Net)|0.034||||0.89|TWO_SIDED|95.0|-0.44|0.51||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|Linear mixed models, controlling for baseline score, were used to compare the SSM and TAU groups' change score from baseline to 12-week on LF HRV.||||0.51|-0.44|0.89
70977386|NCT02149810|141462962|SUPERIORITY||Mean Difference (Net)|-2.66||||0.03|TWO_SIDED|95.0|-5.05|-0.26||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|||||-0.26|-5.05|0.030
70977387|NCT02149810|141462963|SUPERIORITY||Mean Difference (Net)|-2.37||||0.021|TWO_SIDED|95.0|-4.37|-0.36||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|||||-0.36|-4.37|0.021
70977388|NCT02149810|141462964|SUPERIORITY||Mean Difference (Net)|11.0||||0.22|TWO_SIDED|95.0|-7.01|29.01||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|||||29.01|-7.01|0.22
70977389|NCT02149810|141462965|SUPERIORITY||Mean Difference (Net)|1.91||||0.72|TWO_SIDED|95.0|-8.54|12.37||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|||||12.37|-8.54|0.72
70977390|NCT02149810|141462966|SUPERIORITY||Mean Difference (Net)|-0.8||||0.018|TWO_SIDED|95.0|-1.46|-0.15||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|||||-0.15|-1.46|0.018
70977391|NCT02149810|141462967|SUPERIORITY||Mean Difference (Net)|-0.14||||0.99|TWO_SIDED|95.0|-21.94|21.66||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|||||21.66|-21.94|0.99
70977392|NCT02149810|141462968|SUPERIORITY||Odds Ratio (OR)|3.26||||0.049|TWO_SIDED|95.0|1.01|10.53||The a priori threshold for statistical significance was set at p = 0.05.|Regression, Linear|||Generalised linear models were used to compare the proportion of participants who responded to the intervention (≥50% decrease from baseline on the HRSD, defined a priori) at the end of intervention (week 12).||10.53|1.01|0.049
70977393|NCT02149810|141462969|SUPERIORITY||Odds Ratio (OR)|3.36||||0.04|TWO_SIDED|95.0|1.06|10.64||The a priori threshold for statistical significance was set at p = 0.05.|Regression, Linear|||Generalised linear models were used to compare the proportion of the proportion of participants who achieved remission (scores ≤7 on the HRSD, defined a priori) at the end of intervention (week 12).||10.64|1.06|0.040
70977394|NCT01015833|141462974|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.24|TWO_SIDED|95.0|0.8|1.4|||t-test, 1 sided|||||1.4|0.8|0.24
70977395|NCT01015833|141462976|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.98|TWO_SIDED|95.0|0.72|1.2|||t-test, 1 sided|||||1.2|0.72|0.98
70977396|NCT00996203|141462985|SUPERIORITY_OR_OTHER||||||<|0.001||||||EQ-5D scores at Baseline Versus Week 24|t-test, 2 sided|||||||<0.001
70977397|NCT00996203|141462988|SUPERIORITY_OR_OTHER||||||<|0.001||||||General health at baseline Versus Week 24|t-test, 2 sided|||||||<0.001
70977398|NCT00996203|141462990|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline Versus Week 24 DAS28 scores|t-test, 2 sided|||||||<0.001
70977399|NCT00996203|141462992|SUPERIORITY_OR_OTHER||||||<|0.001||||||Mean HAQ scores at Baseline Versus Week 24|t-test, 2 sided|||||||<0.001
70977400|NCT01439945|141462998|SUPERIORITY_OR_OTHER|||||||0.13|||||||ANOVA|Weekly hot flash score was treated as a repeated measure for each patient.||||||0.13
70977401|NCT01439945|141462998|SUPERIORITY_OR_OTHER|||||||0.67|||||||ANOVA|Weekly hot flash score was treated as a repeated measure for each patient.||||||0.67
70977402|NCT01439945|141462999|SUPERIORITY_OR_OTHER|||||||0.25|||||||ANOVA|Weekly number of hot flashes were treated as a repeated measure for each patient.||||||0.25
70977403|NCT01439945|141462999|SUPERIORITY_OR_OTHER|||||||0.55||||||Weekly number of hot flashes were treated as a repeated measure for each patient.|ANOVA|||||||0.55
70977404|NCT01439945|141463002|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
70977405|NCT01439945|141463003|SUPERIORITY_OR_OTHER|||||||0.47|||||||Kruskal-Wallis|||||||0.47
70977406|NCT01439945|141463003|SUPERIORITY_OR_OTHER|||||||0.09|||||||Kruskal-Wallis|||||||0.09
70977407|NCT02730260|141463004|SUPERIORITY_OR_OTHER|||||||0.41|||||||Chi-squared|||Test of the null hypothesis that directive and nondirective coaching have equal smoking cessation rates.||||0.41
70977408|NCT02730260|141463004|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|||<|0.03|TWO_SIDED||||||Regression, Logistic|||Odds ratio based on the parameter estimate for the variable, IncomeAboveMedian (0=false, 1=true), from the logistic regression model representing the a priori hypothesis, which specified income, race, and intervention as independent and interacting variables, and smoking cessation at last contact as the dependent variable. An unbalanced variable, PriorQuit (0-=none in the past year, 1=at least one in the past year) was added to the a priori model.||||<0.03
70977409|NCT02730260|141463004|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||<|0.03|TWO_SIDED||||||Regression, Logistic|||Odds ratio for PriorQuit, from the logistic regression model representing the a priori hypothesis, which specified income, race, and intervention as independent and interacting variables, and smoking cessation at last contact as the dependent variable. This variable, PriorQuit (0-=none in the past year, 1=at least one in the past year) was added to the a priori model because it was not balanced after randomization.||||<0.03
70977410|NCT05032950|141463025|OTHER||Reference/Test Ratio|368.33|||||TWO_SIDED|90.0|318.91|425.41|||Mixed Models Analysis|||Natural log-transformed Cmax of midazolam was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences (AMD) (Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||425.41|318.91|
70977411|NCT05032950|141463026|OTHER||Reference/Test Ratio|1430.02|||||TWO_SIDED|90.0|1204.54|1697.71|||Mixed Models Analysis|||Natural log-transformed AUCinf of midazolam was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences (AMD) (Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||1697.71|1204.54|
70977412|NCT05032950|141463027|OTHER||Test/Reference Ratio|1451.78|||||TWO_SIDED|90.0|1224.42|1721.35|||Mixed Models Analysis|||Natural log-transformed AUClast of midazolam was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences (AMD) (Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||1721.35|1224.42|
70977413|NCT05032950|141463032|OTHER||Test/Reference Ratio|387.2|||||TWO_SIDED|90.0|335.25|447.21|||Mixed Models Analysis|||Natural log-transformed Cmax of midazolam was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences (AMD)(Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||447.21|335.25|
70977414|NCT05032950|141463033|OTHER||Test/Reference Ratio|1645.15|||||TWO_SIDED|90.0|1385.75|1953.11|||Mixed Models Analysis|||Natural log-transformed AUCinf of midazolam was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences (AMD)(Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios||1953.11|1385.75|
70977415|NCT05032950|141463034|OTHER||Test/Reference Ratio|1677.25|||||TWO_SIDED|90.0|1414.59|1988.69|||Mixed Models Analysis|||Natural log-transformed AUClast of midazolam was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences (AMD)(Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||1988.69|1414.59|
70977416|NCT02292771|141463050|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.3797|TWO_SIDED|95.0|-8.879|6.479|||Finite mixture model|||||6.479|-8.879|0.3797
70977417|NCT02292771|141463051|SUPERIORITY||Odds Ratio (OR)|1.0||||0.952|TWO_SIDED|95.0|0.44|2.18|||Regression, Logistic|||||2.18|0.44|0.9520
71095942|NCT00471107|141700296|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||Power analysis was based on WMS-III Word Lists performance. With an effect comparable to the effect on verbal fluency in an earlier study of left frontal TDCS in healthy subjects, it would require 10 subjects per group (30 total) for a significance level of 0.05 and 80% power.||||>0.05
70977418|NCT02292771|141463052|SUPERIORITY||Odds Ratio (OR)|1.0||||0.952|TWO_SIDED|95.0|0.46|2.29|||Regression, Logistic|||||2.29|0.46|0.9520
71095943|NCT02030418|141700347|SUPERIORITY|"The primary safety hypothesis is:~H0: CFR ≤ 86% vs. H1: CFR \> 86% Where CFR is the Complication Free Rate. The CFR is estimated as a binomial proportion and the 95% confidence interval (CI) of CFR is calculated using the Clopper-Pearson exact method. The null hypothesis is rejected at the 2.5% significance level if the lower bound of this CI exceeds the Performance Goal (PG) of 86%."|binomial proportion|93.3|||<|0.001|TWO_SIDED|95.0|89.9|95.9|||1-sided exact test for binomial proporti|||||95.9|89.9|<0.001
70977419|NCT02292771|141463053|SUPERIORITY||Ratio|1.14|STANDARD_ERROR_OF_MEAN|0.222||0.5672|TWO_SIDED|95.0|0.73|1.76|||ANCOVA|||||1.76|0.73|0.5672
70977420|NCT02292771|141463054|SUPERIORITY||Odds Ratio (OR)|1.9||||0.5066|TWO_SIDED|95.0|0.3|11.71|||Regression, Logistic|||||11.71|0.30|0.5066
70977421|NCT02292771|141463060|SUPERIORITY||Odds Ratio (OR)|0.8||||0.779|TWO_SIDED|95.0|0.12|4.84|||Regression, Logistic|||||4.84|0.12|0.7790
70977422|NCT02292771|141463061|SUPERIORITY||Odds Ratio (OR)|1.2||||0.6646|TWO_SIDED|95.0|0.51|2.9|||Regression, Logistic|||||2.90|0.51|0.6646
70977423|NCT02292771|141463062|SUPERIORITY||Odds Ratio (OR)|2.3||||0.1432|TWO_SIDED|95.0|0.75|7.24|||Regression, Logistic|||||7.24|0.75|0.1432
70977424|NCT02292771|141463063|SUPERIORITY||Odds Ratio (OR)|1.5||||0.525|TWO_SIDED|95.0|0.43|5.15|||Regression, Logistic|||||5.15|0.43|0.5250
70977425|NCT02292771|141463064|SUPERIORITY||Odds Ratio (OR)|0.6||||0.4682|TWO_SIDED|95.0|0.13|2.58|||Regression, Logistic|||||2.58|0.13|0.4682
70977426|NCT01475734|141463092|SUPERIORITY_OR_OTHER||Ratio|0.993||||0.791|TWO_SIDED|95.0|0.946|1.043|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 0 hr.|||1.043|0.946|0.791
70977427|NCT01475734|141463092|SUPERIORITY_OR_OTHER||Ratio|1.0|||>|0.999|TWO_SIDED|95.0|0.952|1.05|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 1 hr.|||1.050|0.952|>0.999
71095944|NCT02030418|141700348|SUPERIORITY|"The primary effectiveness hypothesis is:~H0: Rate ≤ 85.0% vs. H1: Rate \> 85.0%~where Rate is the proportion of subjects experiencing success, and success is defined as: pacing threshold voltage ≤ 2.0 V at 0.4 ms at 6-month visit and sensed R-wave amplitude either ≥ 5.0 mV at the 6-month visit or ≥ value at implant."|binomial proportion|93.4|||<|0.001|TWO_SIDED|95.0|89.9|96.0||The null hypothesis is rejected at the 2.5% significance level if the lower bound of the CI exceeds the Performance Goal (PG) of 85%.|1-sided exact test for binomial proporti|||||96.0|89.9|<0.001
70977428|NCT01475734|141463092|SUPERIORITY_OR_OTHER||Ratio|1.001||||0.975|TWO_SIDED|95.0|0.953|1.051|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 1 hr 15 min.|||1.051|0.953|0.975
70977429|NCT01475734|141463092|SUPERIORITY_OR_OTHER||Ratio|1.0|||>|0.999|TWO_SIDED|95.0|0.952|1.05|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 1 hr 45 min.|||1.050|0.952|>0.999
70977430|NCT01475734|141463092|SUPERIORITY_OR_OTHER||Ratio|1.003||||0.908|TWO_SIDED|95.0|0.955|1.053|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 2 hr.|||1.053|0.955|0.908
70977431|NCT01475734|141463092|SUPERIORITY_OR_OTHER||Ratio|1.025||||0.312|TWO_SIDED|95.0|0.977|1.077|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 2 hr 45 min.|||1.077|0.977|0.312
70977432|NCT01475734|141463092|SUPERIORITY_OR_OTHER||Ratio|1.008||||0.763|TWO_SIDED|95.0|0.96|1.058|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 3 hr.|||1.058|0.960|0.763
70977433|NCT01475734|141463092|SUPERIORITY_OR_OTHER||Ratio|1.095|||<|0.001|TWO_SIDED|95.0|1.043|1.15|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 3 hr 30 min.|||1.150|1.043|<0.001
70977434|NCT01475734|141463092|SUPERIORITY_OR_OTHER||Ratio|1.046||||0.07|TWO_SIDED|95.0|0.996|1.098|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 3 hr 45 min.|||1.098|0.996|0.070
70977435|NCT01475734|141463092|SUPERIORITY_OR_OTHER||Ratio|0.971||||0.238|TWO_SIDED|95.0|0.925|1.02|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 4 hr 15 min.|||1.020|0.925|0.238
70977436|NCT01475734|141463092|SUPERIORITY_OR_OTHER||Ratio|0.975||||0.298|TWO_SIDED|95.0|0.928|1.023|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 4 hr 30 min.|||1.023|0.928|0.298
70977437|NCT01475734|141463092|SUPERIORITY_OR_OTHER||Ratio|0.994||||0.821|TWO_SIDED|95.0|0.947|1.044|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 4 hr 45 min.|||1.044|0.947|0.821
71095945|NCT02030418|141700349|OTHER|"The hypothesis is intended to test whether the mean slope is within 35% of 1. The hypothesis is stated as follows:~H0: absolute value (Mean Slope - 100%) ≥ equivalence margin, equal to 35%~H1: absolute value (Mean Slope - 100%) \< equivalence margin, equal to 35%~The calculation of slope for individual subjects in the CAEP exercise protocol is done by setting the y-intercept to zero."|Slope|0.83|STANDARD_DEVIATION|0.27||0.001|TWO_SIDED|95.0|0.73|0.93|||two 1-sided test (TOST)|||||0.93|0.73|0.001
70977438|NCT01475734|141463092|SUPERIORITY_OR_OTHER||Ratio|0.991||||0.715|TWO_SIDED|95.0|0.944|1.04|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 5 hr.|||1.040|0.944|0.715
70977439|NCT01475734|141463092|SUPERIORITY_OR_OTHER||Ratio|1.008||||0.759|TWO_SIDED|95.0|0.96|1.058|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 5 hr 15 min.|||1.058|0.960|0.759
70977440|NCT01475734|141463092|SUPERIORITY_OR_OTHER||Ratio|1.0|||>|0.999|TWO_SIDED|95.0|0.952|1.05|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 5 hr 30 min.|||1.050|0.952|>0.999
70977441|NCT02265913|141463103|EQUIVALENCE|provides 85% of success|Equivalence ratio|98.0|||||TWO_SIDED|90.0|92.0|105.0|||Fieller's method|||||105|92|
70977442|NCT05148884|141463163|OTHER|||||||0.0016|||||||Mixed Models Analysis|||Linear mixed model (LMM) of change from baseline with treatment, visit and the interaction treatment\*visit as fixed categorical effects and subject within treatment as a random effect. The baseline value of the dependent variable has been included in the model as a continuous covariate. Kenward-Roger's improved approximation for degrees of freedom (2009) has been used.||||0.0016
70977443|NCT05148884|141463163|OTHER|||||||0.6886|||||||Mixed Models Analysis|||Linear mixed model (LMM) of change from baseline with treatment, visit and the interaction treatment\*visit as fixed categorical effects and subject within treatment as a random effect. The baseline value of the dependent variable has been included in the model as a continuous covariate. Kenward-Roger's improved approximation for degrees of freedom (2009) has been used.||||0.6886
70977444|NCT05148884|141463164|OTHER|||||||0.0281|||||||Mixed Models Analysis|||Linear mixed model (LMM) of change from baseline with treatment, visit and the interaction treatment\*visit as fixed categorical effects and subject within treatment as a random effect. The baseline value of the dependent variable has been included in the model as a continuous covariate. Kenward-Roger's improved approximation for degrees of freedom (2009) has been used.||||0.0281
70977445|NCT05148884|141463164|OTHER|||||||0.7953|||||||Mixed Models Analysis|||Linear mixed model (LMM) of change from baseline with treatment, visit and the interaction treatment\*visit as fixed categorical effects and subject within treatment as a random effect. The baseline value of the dependent variable has been included in the model as a continuous covariate. Kenward-Roger's improved approximation for degrees of freedom (2009) has been used.||||0.7953
70977446|NCT01993888|141463171|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
70977447|NCT02357420|141463205|SUPERIORITY|||||||0.36|||||||Measures mixed effects model (MMRM)|MMRM analysis used treatment, week, treatment-by-week interaction as fixed factors and baseline values as the covariates.||||||0.36
70977448|NCT02357420|141463205|SUPERIORITY|||||||0.25|||||||MMRM|MMRM analysis used treatment, week, treatment-by-week interaction as fixed factors and baseline values as the covariates.||||||0.25
70977449|NCT02357420|141463205|SUPERIORITY|||||||0.59|||||||MMRM|MMRM analysis used treatment, week, treatment-by-week interaction as fixed factors and baseline values as the covariates.||||||0.59
70977450|NCT00928070|141463210|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.65|STANDARD_ERROR_OF_MEAN|0.21||0.0018|TWO_SIDED|95.0|-1.05|-0.24||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Analysis of covariance (ANCOVA) model with terms for treatment, center, centered baseline, and centered baseline by treatment interaction was used to calculate p-value.||-0.24|-1.05|0.0018
70977451|NCT00928070|141463211|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.23||0.0003|TWO_SIDED|95.0|-1.27|-0.38||Statistical testing, two-sided, was done at 5% significance level.|ANCOVA|||ANCOVA model with terms for treatment, center, centered baseline, and centered baseline by treatment interaction was used to calculate p-value.||-0.38|-1.27|0.0003
70977452|NCT00928070|141463212|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||<0.0001
70977453|NCT00928070|141463212|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0001
70977454|NCT00928070|141463214|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.24||0.0003|TWO_SIDED|95.0|-1.35|-0.4||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline as a covariate was used to calculate p-value.||-0.40|-1.35|0.0003
70977455|NCT00928070|141463214|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.84|STANDARD_ERROR_OF_MEAN|0.23||0.0003|TWO_SIDED|95.0|-1.29|-0.39||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline as a covariate was used to calculate p-value.||-0.39|-1.29|0.0003
70977456|NCT00928070|141463215|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||<0.0001
70977457|NCT00928070|141463215|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||<0.0001
70977458|NCT00928070|141463217|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.34||0.0014|TWO_SIDED|95.0|-1.77|-0.43||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.43|-1.77|0.0014
71095946|NCT00888849|141700350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|7.69||0.7774|TWO_SIDED|95.0|-19.4|10.9||Adjusted for multiplicity via the Bonferroni-Holm method|ANOVA|||||10.9|-19.4|0.7774
70977459|NCT00928070|141463217|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.1|-0.7||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.70|-2.10|<0.0001
70977460|NCT00928070|141463218|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0002
70977461|NCT00928070|141463218|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||<0.0001
70977462|NCT00928070|141463220|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.13||0.2511|TWO_SIDED|95.0|-0.39|0.1||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered Baseline value as a covariate was used to calculate p-value.||0.10|-0.39|0.2511
70977463|NCT00928070|141463220|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.12||0.0189|TWO_SIDED|95.0|-0.53|-0.05||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered Baseline value as a covariate was used to calculate p-value.||-0.05|-0.53|0.0189
71095947|NCT00888849|141700351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|0.8||0.0008|TWO_SIDED|95.0|1.4|4.5||Adjusted for multiplicity via Bonferroni-Holm procedure|ANOVA|||||4.5|1.4|0.0008
71095948|NCT00888849|141700352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.21||0.7774|TWO_SIDED|95.0|-0.2|0.6||Adjusted for multiplicity via Bonferroni-Holm procedure|ANOVA|||||0.6|-0.2|0.7774
71095949|NCT02508207|141700353|OTHER|||||||0.7151||||||p-value for within TEZ/IVA group was analyzed using a 2-sided, paired, t-test at a 5% level of significance.|t-test, 2 sided|||||||0.7151
71095950|NCT02508207|141700354|OTHER|||||||0.0004||||||p-value for within TEZ/IVA group was analyzed using a 2-sided, paired, t-test at a 5% level of significance.|t-test, 2 sided|||||||0.0004
70977464|NCT00928070|141463221|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% significance level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0010
70977465|NCT00928070|141463223|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.67|STANDARD_ERROR_OF_MEAN|1.21||0.0001|TWO_SIDED|95.0|-7.04|-2.3||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-2.30|-7.04|0.0001
70977466|NCT00928070|141463223|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.97|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-7.27|-2.66||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-2.66|-7.27|<0.0001
70977467|NCT00928070|141463224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.11||0.0035|TWO_SIDED|95.0|-0.56|-0.11||Statistical testing, two-sided, was done at 5% alpha level.|t-test, 2 sided|||Change at Week 4: =\<3.5 undergarments- Protective undergarment usage was analyzed to compare treatments on separate subsets, based on baseline protective undergarment use (=\<3.5/day and \>3.5/day), using a 2 sample t-test. This method was applied because there was a statistically significant qualitative baseline by treatment interaction.||-0.11|-0.56|0.0035
70977468|NCT00928070|141463224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|1.21||0.7089|TWO_SIDED|95.0|-2.01|2.92||Statistical testing, two-sided, was done at 5% alpha level.|t-test, 2 sided|||Change at Week 4: \>3.5 undergarments- Protective undergarment usage was analyzed to compare treatments on separate subsets, based on baseline protective undergarment use (=\<3.5/day and \>3.5/day), using a 2 sample t-test. This method was applied because there was a statistically significant qualitative baseline by treatment interaction.||2.92|-2.01|0.7089
70977469|NCT00928070|141463224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.61|-0.21||Statistical testing, two-sided, was done at 5% alpha level.|t-test, 2 sided|||Change at Week 12: =\<2.5 undergarments- Protective undergarment usage was analyzed to compare treatments on separate subsets, based on baseline protective undergarment use (=\<2.5/day and \>2.5/day), using a 2 sample t-test. This method was applied because there was a statistically significant qualitative baseline by treatment interaction.||-0.21|-0.61|<0.0001
70977470|NCT00928070|141463224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.47||0.7437|TWO_SIDED|95.0|-0.78|1.09||Statistical testing, two-sided, was done at 5% alpha level.|t-test, 2 sided|||Change at Week 12: \>2.5 undergarments- Protective undergarment usage was analyzed to compare treatments on separate subsets, based on baseline protective undergarment use (=\<2.5/day and \>2.5/day), using a 2 sample t-test. This method was applied because there was a statistically significant qualitative baseline by treatment interaction.||1.09|-0.78|0.7437
70977471|NCT00928070|141463225|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Cochran-Mantel-Haenszel|||Change at Week 4- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for center was used to calculate p-value.||||0.0009
71095951|NCT02508207|141700355|OTHER|||||||0.3345|||||||t-test, 2 sided|p-value for within TEZ/IVA group was analyzed using a 2-sided, paired, t-test at a 5% level of significance.||||||0.3345
70977472|NCT00928070|141463225|SUPERIORITY_OR_OTHER|||||||0.0021|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: CMH test with modified ridit scoring controlling for center was used to calculate p-value.||||0.0021
70977473|NCT00928070|141463227|SUPERIORITY_OR_OTHER||Least squares mean difference|-9.15|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|-12.85|-5.45||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-5.45|-12.85|<0.0001
70977474|NCT00928070|141463227|SUPERIORITY_OR_OTHER||Least squares mean difference|-7.6|STANDARD_ERROR_OF_MEAN|2.03||0.0002|TWO_SIDED|95.0|-11.6|-3.61||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-3.61|-11.60|0.0002
70977475|NCT00928070|141463229|SUPERIORITY_OR_OTHER||Least squares mean difference|8.17|STANDARD_ERROR_OF_MEAN|2.08|<|0.0001|TWO_SIDED|95.0|4.09|12.25||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: concern domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||12.25|4.09|<0.0001
70977476|NCT00928070|141463229|SUPERIORITY_OR_OTHER||Least squares mean difference|6.96|STANDARD_ERROR_OF_MEAN|2.13||0.0012|TWO_SIDED|95.0|2.77|11.15||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: coping domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||11.15|2.77|0.0012
70977477|NCT00928070|141463229|SUPERIORITY_OR_OTHER||Least squares mean difference|4.0|STANDARD_ERROR_OF_MEAN|2.01||0.0472|TWO_SIDED|95.0|0.05|7.95||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: sleep domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||7.95|0.05|0.0472
70977478|NCT00928070|141463229|SUPERIORITY_OR_OTHER||Least squares mean difference|2.46|STANDARD_ERROR_OF_MEAN|1.53||0.1087|TWO_SIDED|95.0|-0.55|5.46||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: social interaction domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||5.46|-0.55|0.1087
70977479|NCT00928070|141463229|SUPERIORITY_OR_OTHER||Least squares mean difference|5.79|STANDARD_ERROR_OF_MEAN|1.77||0.0012|TWO_SIDED|95.0|2.31|9.28||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: total- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||9.28|2.31|0.0012
70977480|NCT00928070|141463229|SUPERIORITY_OR_OTHER||Least squares mean difference|9.04|STANDARD_ERROR_OF_MEAN|2.19|<|0.0001|TWO_SIDED|95.0|4.75|13.33||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: concern domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||13.33|4.75|<0.0001
70977481|NCT00928070|141463229|SUPERIORITY_OR_OTHER||Least squares mean difference|5.32|STANDARD_ERROR_OF_MEAN|2.22||0.0169|TWO_SIDED|95.0|0.96|9.67||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: coping domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||9.67|0.96|0.0169
71095952|NCT02508207|141700356|OTHER|||||||0.0002||||||p-value for within TEZ/IVA group was analyzed using a 2-sided, paired, t-test at a 5% level of significance.|t-test, 2 sided|||||||0.0002
71095953|NCT03296345|141700362|OTHER||Mean Difference (Final Values)|-15.0||||0.004|TWO_SIDED|95.0|-28.0|-2.3|||Wilcoxon (Mann-Whitney)|||||-2.3|-28|0.004
71095954|NCT03296345|141700363|OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
71095955|NCT03296345|141700364|OTHER|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||||||0.58
71095956|NCT03296345|141700366|OTHER|A Wilcoxon sign-rank, given non parametric data, was used to compare the intervention and historical control groups for statistical significance, while a student's t-test was used to estimate effect size||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
70977482|NCT00928070|141463229|SUPERIORITY_OR_OTHER||Least squares mean difference|4.05|STANDARD_ERROR_OF_MEAN|2.1||0.0546|TWO_SIDED|95.0|-0.08|8.17||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: sleep domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||8.17|-0.08|0.0546
71095957|NCT06100250|141700444|OTHER|Paired sample t-test, 2 sided|Mean Difference (Net)|0.82||||0.01|TWO_SIDED|||||A priori threshold for statistical significance = 0.05|Paired sample t-test, 2 sided|Degrees of freedom = 66|Estimation parameter represents the average of the differences between the paired observations (post-intervention score minus pre-intervention score)|Null hypothesis = Mean difference between the paired STI-related knowledge scores (pre-intervention and post-intervention) is 0||||0.01
70977483|NCT00928070|141463229|SUPERIORITY_OR_OTHER||Least squares mean difference|2.35|STANDARD_ERROR_OF_MEAN|1.63||0.1497|TWO_SIDED|95.0|-0.85|5.55||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: social interaction domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||5.55|-0.85|0.1497
70977484|NCT00928070|141463229|SUPERIORITY_OR_OTHER||Least squares mean difference|5.53|STANDARD_ERROR_OF_MEAN|1.88||0.0034|TWO_SIDED|95.0|1.84|9.23||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: total- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||9.23|1.84|0.0034
70977485|NCT00928070|141463230|SUPERIORITY_OR_OTHER||Least squares mean difference|16.25|STANDARD_ERROR_OF_MEAN|2.96|<|0.0001|TWO_SIDED|95.0|10.43|22.08||Statistical testing, two-sided, was done at 5% significance level.|ANOVA|||ANOVA model with treatment and center as factors was used to calculate p-value.||22.08|10.43|<0.0001
70977486|NCT00928070|141463231|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Cochran-Mantel-Haenszel|||Not satisfied, neither dissatisfied nor satisfied, satisfied: CMH test with modified ridit scoring controlling for center was used.||||<0.0001
70977487|NCT00928070|141463233|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.17||0.2788|TWO_SIDED|95.0|-0.51|0.15||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||ANCOVA model with terms for treatment, center, centered baseline value, and centered baseline by treatment interaction.||0.15|-0.51|0.2788
70977488|NCT00928070|141463234|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.0||||0.0021|TWO_SIDED|95.0|0.0|8.0||Statistical testing, two-sided, was done at 5% alpha level.|Van Elteren's test|||Change at Week 4: Van Elteren's test adjusted by baseline PVR quartile was used to calculate p-value. The median difference was based on Hodges-Lehmann estimate.||8.00|0.00|0.0021
70977489|NCT00928070|141463234|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|7.0|||<|0.0001|TWO_SIDED|95.0|3.0|11.0||Statistical testing, two-sided, was done at 5% alpha level.|Van Elteren's test|||Change at Week 12: Van Elteren's test adjusted by baseline PVR quartile was used to calculate p-value. The median difference was based on Hodges-Lehmann estimate.||11.00|3.00|<0.0001
71095958|NCT06100250|141700446|OTHER|Paired sample t-test, 2 sided|Mean Difference (Net)|-1.29|||<|0.01|TWO_SIDED|||||A priori threshold for statistical significance = 0.05|Paired sample t-test, 2 sided|Degrees of freedom = 47|Estimation parameter represents the average of the differences between the paired observations (post-intervention score minus pre-intervention score)|Null hypothesis = Mean difference between the paired self-efficacy for specimen self-collection scores (pre-intervention and post-intervention) is 0||||<0.01
70977490|NCT00891995|141463237|SUPERIORITY_OR_OTHER|||||||0.49||||||One-sided p-value.|ANCOVA|Adjusted for baseline C-peptide AUC, age, gender and diabetic ketoacidosis.||||||0.49
70977491|NCT00891995|141463240|SUPERIORITY_OR_OTHER|||||||0.4||||||One-sided p-value|ANCOVA|Adjusted for baseline A1c, age, gender and Diabetic ketoacidosis||||||0.40
70977492|NCT02054702|141463246|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in PANSS total score from baseline to week 6 for brexpiprazole.||||<0.0001
70977493|NCT02054702|141463246|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in PANSS total score from baseline to week 6 for aripiprazole.||||<0.0001
71095959|NCT02021318|141700449|NON_INFERIORITY|Non-inferiority of roxadustat versus darbepoetin alfa, margin = -15% (non-inferiority is concluded if the lower limit of the 95% confidence interval of the difference was \>-15%).|Difference in percentage|11.51|||||TWO_SIDED|95.0|5.66|17.36||||||A generalized linear model as an approximation for the Miettinen and Nurminen method, adjusted for stratification factors (actual) was used to estimate the difference of proportions and 95% confidence interval.||17.36|5.66|
71095960|NCT02021318|141700450|NON_INFERIORITY|Non-Inferiority, margin = -0.75 (non-inferiority is concluded if the lower bound of the 95% CI of the least square mean difference (LSM) is \> -0.75 g/dL).|LSM Difference|0.015||||0.839|TWO_SIDED|95.0|-0.131|0.162|||Mixed Models Analysis|||The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.162|-0.131|0.839
71095961|NCT02021318|141700451|SUPERIORITY||LSM Difference|-0.403|||<|0.001|TWO_SIDED|95.0|-0.51|-0.296|||Mixed Models Analysis|||The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline LDL, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||-0.296|-0.510|<0.001
71095962|NCT02021318|141700452|SUPERIORITY||Hazard Ratio (HR)|0.45||||0.004|TWO_SIDED|95.0|0.26|0.78|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on cardiovascular history and region and adjusting on Hb and eGFR at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI was below 1.0.||0.78|0.26|0.004
71095963|NCT02021318|141700453|NON_INFERIORITY|Non-Inferiority, margin = -3 (non-inferiority is concluded if the lower bound of the 95% confidence interval of the LSM difference is \> -3 points).|LSM Difference|-1.284||||0.027|TWO_SIDED|95.0|-2.423|-0.145|||Mixed Models Analysis|||The model included treatment, visit (weeks 8, 12 and 28) visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline SF-36 PF, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||-0.145|-2.423|0.027
70922326|NCT05028582|141335620|SUPERIORITY|Change from Baseline in PASI Week 2|LS Mean Difference|-1.28|||<|0.0001|TWO_SIDED|97.5|-1.71|-0.85|||ANCOVA|Covariate terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline PASI score \& multiple imputation to handle missing data|Covariate terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline PASI score \& multiple imputation to handle missing data|||-0.85|-1.71|<0.0001
70922327|NCT04402294|141335631|OTHER|Parametric inferential statistical test|Group mean difference|0.71||||0.5|TWO_SIDED|||||The threshold for statistical significance was set to p = 0.05|ANOVA|||ANOVA (Optimal vs Suboptimal vs No Stimulation)||||0.50
70922328|NCT04402294|141335632|OTHER|Parametric inferential statistical test|Group mean difference|0.03||||0.975|TWO_SIDED|||||The threshold for statistical significance was set to p = 0.05|ANOVA|||ANOVA (Optimal vs Suboptimal vs No Stimulation)||||0.975
70922329|NCT04402294|141335633|OTHER|Parametric inferential statistical test|Group mean difference|2.05||||0.097|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|ANOVA|||ANOVA, with neuromodulation stimulation type (optimal vs. suboptimal), stimulation days (1 to 3), and delay (0, 4, or 12 seconds) as within-subject variables.||||0.097
70922330|NCT04402294|141335634|OTHER|Parametric Inferential Statistical Test|Group mean difference|0.63||||0.644|TWO_SIDED|||||The threshold for statistical significance was 0.05|ANOVA|||ANOVA, with neuromodulation stimulation type (optimal vs. suboptimal), stimulation days (1 to 3), and delay (0, 4, or 12 seconds) as within-subject variables.||||0.644
70922331|NCT04402294|141335635|OTHER|Parametric inferential statistical test|Group mean difference|0.84||||0.439|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|ANOVA|||ANOVA, with neuromodulation stimulation type (optimal vs. suboptimal), and stimulation days (1 to 3) as within-subject variables.||||0.439
70922332|NCT04402294|141335636|OTHER|Parametric inferential statistical test|Group mean difference|0.59||||0.563|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|ANOVA|||Optimal Neuromodulation Day-1, Optimal Neuromodulation Day-2, Optimal Neuromodulation Day-3, Suboptimal Neuromodulation Day-1, Suboptimal Neuromodulation Day-2, Suboptimal Neuromodulation Day-3||||0.563
70922333|NCT05478525|141335661|SUPERIORITY||Least Squares (LS) Mean Difference|-35.05||||0.0007|TWO_SIDED|95.0|-54.35|-15.75|||ANCOVA|||Analysis at Week 2||-15.75|-54.35|0.0007
70922334|NCT05478525|141335661|SUPERIORITY||LS Mean Difference|-23.14||||0.0193|TWO_SIDED|95.0|-42.32|-3.97|||ANCOVA|||Analysis at Week 2||-3.97|-42.32|0.0193
70977494|NCT02054702|141463247|SUPERIORITY_OR_OTHER|||||||0.4244|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test composite battery score from baseline to week 6 for brexpiprazole.||||0.4244
70922335|NCT05478525|141335661|SUPERIORITY||LS Mean Difference|-21.64||||0.0243|TWO_SIDED|95.0|-40.33|-2.96|||ANCOVA|||Analysis at Week 2||-2.96|-40.33|0.0243
70922336|NCT05478525|141335663|SUPERIORITY||LS Mean Difference|-155.68||||0.0298|TWO_SIDED|95.0|-295.35|-16.01|||ANCOVA|||Analysis at Day 14||-16.01|-295.35|0.0298
70922337|NCT05478525|141335663|SUPERIORITY||LS Mean Difference|-143.74||||0.0433|TWO_SIDED|95.0|-282.92|-4.55|||ANCOVA|||Analysis at Day 14||-4.55|-282.92|0.0433
70922338|NCT05478525|141335663|SUPERIORITY||LS Mean Difference|-178.33||||0.0201|TWO_SIDED|95.0|-327.16|-29.5|||ANCOVA|||Analysis at Day 14||-29.50|-327.16|0.0201
70922339|NCT05478525|141335664|SUPERIORITY||LS Mean Difference|-47.07||||0.1992|TWO_SIDED|95.0|-119.94|25.81|||ANCOVA|||Analysis at Day 14||25.81|-119.94|0.1992
70922340|NCT05478525|141335664|SUPERIORITY||LS Mean Difference|-70.32||||0.0617|TWO_SIDED|95.0|-144.26|3.61|||ANCOVA|||Analysis at Day 14||3.61|-144.26|0.0617
70922341|NCT05478525|141335664|SUPERIORITY||LS Mean Difference|-39.84||||0.2981|TWO_SIDED|95.0|-116.22|36.53|||ANCOVA|||Analysis at Day 14||36.53|-116.22|0.2981
71095964|NCT02021318|141700454|NON_INFERIORITY|Non-Inferiority, margin = -3 (non-inferiority is concluded if the lower bound of the 95% confidence interval of the LSM difference is \> -3 points).|LSM Difference|-0.457||||0.454|TWO_SIDED|95.0|-1.656|0.742|||Mixed Models Analysis|||The model included treatment, visit (weeks 8, 12 and 28), visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline SF-36 VT, baseline Hb, baseline eGFR as continuous covariates.||0.742|-1.656|0.454
70922342|NCT05644002|141335667|OTHER||Mean Difference (Final Values)|2.06||||0.71|TWO_SIDED|95.0|-9.09|13.21||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress-induction Omax between the PTBT and Control conditions.||13.21|-9.09|.71
70922343|NCT05644002|141335667|OTHER||t-statistic|0.369|||||TWO_SIDED||||||t-test, 2 sided|degrees freedom = 66||An independent-samples t-test was conducted to examine differences in post-stress induction Omax between the PTBT and Control conditions.||||
70922344|NCT05644002|141335667|OTHER||Hedge's g|0.09|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction Omax between the PTBT and Control conditions.||||
70922345|NCT05644002|141335668|OTHER||Mean Difference (Final Values)|0.251||||0.53|TWO_SIDED|95.0|-0.543|1.046||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ cigarette satisfaction between the PTBT and Control conditions.||1.046|-.543|.530
70922346|NCT05644002|141335668|OTHER||t-statistic|0.631|||||TWO_SIDED||||||t-test, 2 sided|degrees freedom = 73||An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ cigarette satisfaction between the PTBT and Control conditions.||||
70922347|NCT05644002|141335668|OTHER||Hedge's g|0.14|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction mCEQ cigarette satisfaction between the PTBT and Control conditions.||||
71095965|NCT02021318|141700455|NON_INFERIORITY|Non-Inferiority, margin = 1 mmHg (non-inferiority is concluded if the upper bound of the 95% confidence interval of the LSM difference is \< 1).|LSM Difference|-0.372||||0.547|TWO_SIDED|95.0|-1.587|0.842|||Mixed Models Analysis|||The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline MAP, baseline Hb, baseline eGFR as continuous covariates.||0.842|-1.587|0.547
71095966|NCT02021318|141700456|NON_INFERIORITY|Non-inferiority (hazard ratio margin of 1.3). Non-Inferiority was declared if the upper bound of the 95% CI is below 1.3.|Hazard Ratio (HR)|0.83||||0.336|TWO_SIDED|95.0|0.56|1.22|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and Region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.22|0.56|0.336
71095967|NCT02021318|141700457|SUPERIORITY||LSM Difference|-0.136||||0.818|TWO_SIDED|95.0|-1.299|1.026|||Mixed Models Analysis|||The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline MAP, baseline Hb, baseline eGFR as continuous covariates.||1.026|-1.299|0.818
71095968|NCT02021318|141700458|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.452|TWO_SIDED|95.0|0.6|1.26|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on cardiovascular history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI is lower than 1.||1.26|0.60|0.452
71095969|NCT02021318|141700459|SUPERIORITY||LSM Difference|0.038||||0.529|TWO_SIDED|95.0|-0.081|0.157|||Mixed Models Analysis|||The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.157|-0.081|0.529
70977495|NCT02054702|141463247|SUPERIORITY_OR_OTHER|||||||0.7623|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test composite battery score from baseline to week 6 for aripiprazole.||||0.7623
70977496|NCT02054702|141463248|SUPERIORITY_OR_OTHER|||||||0.8759|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery of early phase battery score from baseline to week 6 for aripiprazole.||||0.8759
71095970|NCT02021318|141700460|SUPERIORITY||Hazard Ratio (HR)|1.64|||<|0.001|TWO_SIDED|95.0|1.38|1.96|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on cardiovascular history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.96|1.38|<0.001
71095971|NCT02021318|141700461|SUPERIORITY||Hazard Ratio (HR)|1.66|||<|0.001|TWO_SIDED|95.0|1.39|1.98|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.98|1.39|<0.001
71095972|NCT02021318|141700462|SUPERIORITY||LSM Difference|0.051||||0.478|TWO_SIDED|95.0|-0.091|0.194|||Mixed Models Analysis|||Weeks 28-36 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.194|-0.091|0.478
71095973|NCT02021318|141700462|SUPERIORITY||LSM Difference|-0.003||||0.969|TWO_SIDED|95.0|-0.149|0.143|||Mixed Models Analysis|||Weeks 44-52 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.143|-0.149|0.969
71095974|NCT02021318|141700462|SUPERIORITY||LSM Difference|0.009||||0.91|TWO_SIDED|95.0|-0.14|0.157|||Mixed Models Analysis|||Weeks 72-80 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.157|-0.140|0.910
71095975|NCT02021318|141700462|SUPERIORITY||LSM Difference|0.024||||0.775|TWO_SIDED|95.0|-0.14|0.188|||Mixed Models Analysis|||Weeks 96-104 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.188|-0.140|0.775
71095976|NCT02021318|141700463|SUPERIORITY||LSM Difference|0.087||||0.086|TWO_SIDED|95.0|-0.012|0.185|||Mixed Models Analysis|||Week 1- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.185|-0.012|0.086
71095977|NCT02021318|141700463|SUPERIORITY||LSM Difference|0.278|||<|0.001|TWO_SIDED|95.0|0.165|0.391|||Mixed Models Analysis|||Week 2- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.391|0.165|<0.001
70922348|NCT05644002|141335669|OTHER||Mean Difference (Final Values)|0.889||||0.66|TWO_SIDED|95.0|-3.149|4.927||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress intensity between the PTBT and Control conditions.||4.927|-3.149|.66
70922349|NCT05644002|141335669|OTHER||t-statistic|0.439|||||TWO_SIDED||||||t-test, 2 sided|degrees of freedom = 66||An independent-samples t-test was conducted to examine differences in post-stress induction intensity between the PTBT and Control conditions.||||
70922350|NCT05644002|141335669|OTHER||Hedge's g|-0.11|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction intensity between the PTBT and Control conditions.||||
70922351|NCT05644002|141335670|OTHER||Mean Difference (Final Values)|-0.698||||0.77|TWO_SIDED|95.0|-5.443|4.046||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress-induction Pmax between the PTBT and Control conditions.||4.046|-5.443|.77
70922352|NCT05644002|141335670|OTHER||t-statistic|-0.294|||||TWO_SIDED||||||t-test, 2 sided|degrees freedom = 66||An independent-samples t-test was conducted to examine differences in post-stress induction Pmax between the PTBT and Control conditions.||||
70977497|NCT02054702|141463248|SUPERIORITY_OR_OTHER|||||||0.2176|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery of early phase battery score from baseline to week 6 for aripiprazole.||||0.2176
70977498|NCT02054702|141463249|SUPERIORITY_OR_OTHER|||||||0.842|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of GML from baseline to week 6 for brexpiprazole.||||0.8420
70977499|NCT02054702|141463249|SUPERIORITY_OR_OTHER|||||||0.3781|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of GML from baseline to week 6 for aripiprazole.||||0.3781
70977500|NCT02054702|141463250|SUPERIORITY_OR_OTHER|||||||0.1807|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of detection task from baseline to week 6 for brexpiprazole.||||0.1807
70977501|NCT02054702|141463250|SUPERIORITY_OR_OTHER|||||||0.2802|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of detection task from baseline to week 6 for aripiprazole.||||0.2802
70977502|NCT02054702|141463251|SUPERIORITY_OR_OTHER|||||||0.8622|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of identification task from baseline to week 6 for brexpiprazole.||||0.8622
70977503|NCT02054702|141463251|SUPERIORITY_OR_OTHER|||||||0.4848|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of identification task from baseline to week 6 for aripiprazole.||||0.4848
70977504|NCT02054702|141463252|SUPERIORITY_OR_OTHER|||||||0.8588|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of one card learning task from baseline to week 6 for brexpiprazole.||||0.8588
70977505|NCT02054702|141463252|SUPERIORITY_OR_OTHER|||||||0.9928|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of one card learning task from baseline to week 6 for aripiprazole.||||0.9928
70977506|NCT02054702|141463253|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in CGI-S from baseline to week 6 for brexpiprazole.||||<0.0001
70977507|NCT02054702|141463253|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in CGI-S from baseline to week 6 were observed for aripiprazole.||||<0.0001
70977508|NCT02054702|141463256|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|The analysis of covariance (ANCOVA) model with treatment group and total score at baseline as covariate was used for change from baseline comparisons.||Statistical analysis is mean change in SLOF total score from baseline to week 6 for brexpiprazole.||||<0.0001
70977509|NCT02054702|141463256|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|The ANCOVA model, with treatment group as main effect and total score at baseline as covariate, was used for change from baseline comparisons.||Statistical analysis is mean change in SLOF total score from baseline to week 6 for aripiprazole.||||<0.0001
70977510|NCT02054702|141463257|SUPERIORITY_OR_OTHER|||||||0.0392|TWO_SIDED||||||ANCOVA|The ANCOVA model, with treatment group as main effect and total score at baseline as covariate, was used for change from baseline comparisons.||Statistical analysis is mean change in BIS-11 item total score from baseline to week 6 for brexpiprazole.||||0.0392
70977511|NCT02054702|141463257|SUPERIORITY_OR_OTHER|||||||0.9716|TWO_SIDED||||||ANCOVA|The ANCOVA model, with treatment group as main effect and total score at baseline as covariate, was used for change from baseline comparisons.||Statistical analysis is mean change in BIS-11 item total score from baseline to week 6 for aripiprazole.||||0.9716
70977512|NCT02304926|141463261|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70977513|NCT02304926|141463262|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70977514|NCT02304926|141463263|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70977515|NCT02304926|141463264|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
70977516|NCT02304926|141463265|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
70977517|NCT02304926|141463266|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70977518|NCT02304926|141463267|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70977519|NCT02304926|141463268|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70977520|NCT02304926|141463269|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70977521|NCT02304926|141463270|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70977522|NCT02304926|141463271|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70977523|NCT02304926|141463272|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70977524|NCT02304926|141463273|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70977525|NCT02304926|141463274|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70977526|NCT02304926|141463275|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70977527|NCT02304926|141463276|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70977528|NCT02304926|141463277|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70977529|NCT02304926|141463278|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
70977530|NCT02304926|141463279|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71095978|NCT02021318|141700463|SUPERIORITY||LSM Difference|0.435|||<|0.001|TWO_SIDED|95.0|0.284|0.586|||Mixed Models Analysis|||Week 4- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.586|0.284|<0.001
71095979|NCT02021318|141700463|SUPERIORITY||LSM Difference|0.422|||<|0.001|TWO_SIDED|95.0|0.254|0.59|||Mixed Models Analysis|||Week 6- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.590|0.254|<0.001
71095980|NCT02021318|141700463|SUPERIORITY||LSM Difference|0.38|||<|0.001|TWO_SIDED|95.0|0.205|0.556|||Mixed Models Analysis|||Week 8- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.556|0.205|<0.001
71095981|NCT02021318|141700463|SUPERIORITY||LSM Difference|0.33|||<|0.001|TWO_SIDED|95.0|0.155|0.505|||Mixed Models Analysis|||Week 10- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.505|0.155|<0.001
71095982|NCT02021318|141700463|SUPERIORITY||LSM Difference|0.3||||0.001|TWO_SIDED|95.0|0.119|0.482|||Mixed Models Analysis|||Week 12- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.482|0.119|0.001
70922353|NCT05644002|141335670|OTHER||Hedge's g|-0.071|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction Pmax between the PTBT and Control conditions.||||
70922354|NCT05644002|141335671|OTHER||Mean Difference (Final Values)|-0.354||||0.9|TWO_SIDED|95.0|-6.009|5.3||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress-induction breakpoint between the PTBT and Control conditions.||5.300|-6.009|.90
70922355|NCT05644002|141335671|OTHER||t-statistic|-0.125|||||TWO_SIDED||||||t-test, 2 sided|degrees of freedom = 66||An independent-samples t-test was conducted to examine differences in post-stress induction breakpoint between the PTBT and Control conditions.||||
70922356|NCT05644002|141335671|OTHER||Hedge's g|-0.03|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction breakpoint between the PTBT and Control conditions.||||
70922357|NCT05644002|141335672|OTHER||Mean Difference (Final Values)|-0.748||||0.09|TWO_SIDED|95.0|-1.601|0.105||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ craving reduction between the PTBT and Control conditions.||.105|-1.601|.09
70922358|NCT05644002|141335672|OTHER||t-statistic|-1.75|||||TWO_SIDED||||||t-test, 2 sided|degrees freedom = 65.261||An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ craving reduction between the PTBT and Control conditions.||||
70922359|NCT05644002|141335672|OTHER||Hedge's g|-0.405|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction mCEQ craving reduction between the PTBT and Control conditions.||||
70922360|NCT05644002|141335673|OTHER||Mean Difference (Final Values)|0.184||||0.666|TWO_SIDED|95.0|-0.663|1.031||The threshold for statistical significance was p\<.05|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ psychological reward between the PTBT and Control conditions.||1.031|-.663|.666
70922361|NCT05644002|141335673|OTHER||t-statistic|0.184|||||TWO_SIDED||||||t-test, 2 sided|degrees freedom = 73||An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ psychological reward between the PTBT and Control conditions.||||
70922362|NCT05644002|141335673|OTHER||Hedge's g|0.099|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction mCEQ psychological reward between the PTBT and Control conditions.||||
70922363|NCT05644002|141335674|OTHER||β|0.026||||0.73|TWO_SIDED|95.0|-0.358|0.507||The threshold for statistical significance was p\<.05.|Regression, Linear|Coding: Control=0, PTBT=1.||A multiple linear regression test was conducted to examine whether the PTBT intervention (versus control) significantly predicted post-stress-induction respiratory sinus arrhythmia during smoking, while controlling for average baseline respiratory sinus arrhythmia at step 1 of the model.||.507|-.358|.73
71095983|NCT02021318|141700463|SUPERIORITY||LSM Difference|0.159||||0.079|TWO_SIDED|95.0|-0.018|0.336|||Mixed Models Analysis|||Week 14- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.336|-0.018|0.079
71095984|NCT02021318|141700463|SUPERIORITY||LSM Difference|0.183||||0.044|TWO_SIDED|95.0|0.005|0.361|||Mixed Models Analysis|||Week 16- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.361|0.005|0.044
71095985|NCT02021318|141700463|SUPERIORITY||LSM Difference|0.173||||0.037|TWO_SIDED|95.0|0.01|0.336|||Mixed Models Analysis|||Week 18- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.336|0.010|0.037
71095986|NCT02021318|141700463|SUPERIORITY||LSM Difference|0.085||||0.319|TWO_SIDED|95.0|-0.083|0.253|||Mixed Models Analysis|||Week 20- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.253|-0.083|0.319
70922364|NCT05644002|141335674|OTHER||t-statistic|0.345|||||TWO_SIDED||||||Regression, Linear|degrees freedom = (2, 73)|Condition (0=control; 1=PTBT)|A multiple linear regression test was conducted to examine whether the PTBT intervention (versus control) significantly predicted post-stress induction respiratory sinus arrhythmia during smoking, while controlling for average baseline respiratory sinus arrythmia at step 1 of the model.||||
70977531|NCT02304926|141463280|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70977532|NCT00331006|141463295|SUPERIORITY_OR_OTHER||Proportion|0.1875||||0.043|ONE_SIDED|95.0|0.053|||the a priori p-value was 0.05 for statistical significance|Exact Binomial|||The null hypothesis is that the proportion of participants in which the inhibitor level falls to less than 5 BU/mL between weeks 6 to 22 and remains below 5 BU/mL at 5-7 days following re-challenge with factor VIII is no more than 0.05|||.053|0.043
70977533|NCT00331006|141463296|SUPERIORITY_OR_OTHER||Proportion|0.25|||||TWO_SIDED|95.0|0.073|0.524|||Exact Binomial|||No hypothesis about the value of this proportion was specified in the study design||0.524|0.073|
70977534|NCT00109473|141463310|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.0||||0.02|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.02
70977535|NCT02706938|141463322|OTHER|One tail paired t test.|Mean Difference (Final Values)|1.3267|STANDARD_DEVIATION|2.1604||0.0002|TWO_SIDED|95.0|0.6263|2.027||A priori threshold for statistical significance was 0.05|t-test, 1 sided|||||2.0270|0.6263|0.0002
70977536|NCT02706938|141463322|OTHER|McNemar's chi squared statistic|Risk Difference (RD)|-0.359||||0.0082|TWO_SIDED|95.0|-0.6255|-0.0924||A priori threshold for statistical significance was 0.05|McNemar|||||-0.0924|-0.6255|0.0082
70977537|NCT02706938|141463323|OTHER|One tail paired t test.|Mean Difference (Final Values)|-6.9131|STANDARD_DEVIATION|32.5093||0.099|TWO_SIDED|95.0|-17.5987|3.7724||A priori threshold for statistical significance was 0.05|t-test, 1 sided|||||3.7724|-17.5987|0.099
70977538|NCT02706938|141463323|OTHER|McNemar's chi squared statistic|Risk Difference (RD)|-0.0263||||0.8084|TWO_SIDED|95.0|-0.2651|0.2125||A priori threshold for statistical significance was 0.05|McNemar|||||0.2125|-0.2651|0.8084
70977539|NCT01838044|141463325|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.287||0.6012|TWO_SIDED|95.0|-0.72|0.42|||Mixed Models Analysis|||Statistical analysis at Week 5 compared between two study arms.||0.42|-0.72|0.6012
70977540|NCT01838044|141463326|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.42|||<|0.0001|TWO_SIDED|95.0|1.02|1.83|||Mixed Models Analysis|||Statistical analysis of weekly mean pain NRS score in Arm B at Week 10.||1.83|1.02|<0.0001
70977541|NCT01838044|141463327|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.361||0.5128|TWO_SIDED|95.0|-0.48|0.95|||Mixed Models Analysis|||Statistical analysis of weekly mean pain NRS score in Arm B compared between two study arms at Week 10.||0.95|-0.48|0.5128
70977542|NCT01838044|141463329|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.7251|TWO_SIDED|95.0|-0.22|0.32|||Mixed Models Analysis|||Statistical analysis at Week 5 based on comparison between treatment groups.||0.32|-0.22|0.7251
70977543|NCT01838044|141463329|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1255|TWO_SIDED|95.0|-0.06|0.46|||Mixed Models Analysis|||Statistical analysis at Week 10 based on comparison between treatment groups.||0.46|-0.06|0.1255
70977544|NCT01838044|141463331|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.317||0.2856|TWO_SIDED|95.0|-0.97|0.29|||Mixed Models Analysis|||Statistical analysis at Week 5 compared between treatment groups.||0.29|-0.97|0.2856
70977545|NCT01838044|141463331|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.363||0.3987|TWO_SIDED|95.0|-1.02|0.41|||Mixed Models Analysis|||Statistical analysis at Week 10 compared between treatment groups.||0.41|-1.02|0.3987
70977546|NCT00860470|141463348|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.95||||0.36|TWO_SIDED|95.0|0.86|1.06|||Regression, Logistic|Bonferroni-adjusted alpha=0.01 (for 5 comparisons)|GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||1.06|0.86|0.36
70977547|NCT00860470|141463349|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.98||||0.78|TWO_SIDED|95.0|0.88|1.2|||Regression, Logistic||GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||1.20|0.88|0.78
70977548|NCT00860470|141463350|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.81||||0.11|TWO_SIDED|95.0|0.63|1.04|||Regression, Logistic||GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||1.04|0.63|0.11
70977549|NCT00860470|141463351|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.89||||0.02|TWO_SIDED|95.0|0.81|0.99|||Regression, Logistic|Bonferroni-adjusted alpha=0.01 (for 5 comparisons)|GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||0.99|0.81|0.02
70977550|NCT00860470|141463352|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.85|||<|0.001|TWO_SIDED|95.0|0.8|0.91|||Regression, Logistic|Bonferroni-adjusted alpha=0.01 (for 5 comparisons)|GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||0.91|0.80|<0.001
70977551|NCT00860470|141463353|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.75||||0.03|TWO_SIDED|95.0|0.57|0.97|||Regression, Logistic||GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||0.97|0.57|0.03
70977552|NCT00860470|141463354|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.73|||<|0.001|TWO_SIDED|95.0|0.62|0.86|||Regression, Logistic||GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||0.86|0.62|<0.001
70977553|NCT00860470|141463355|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.87||||0.87|TWO_SIDED|95.0|0.81|0.93|||Regression, Logistic||GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||0.93|0.81|0.87
70977554|NCT00860470|141463356|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.88|||<|0.001|TWO_SIDED|95.0|0.85|0.91|||Regression, Logistic|Bonferroni-adjusted alpha=0.01 (for 5 comparisons)|GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||0.91|0.85|<0.001
70977555|NCT00860470|141463357|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.98||||0.13|TWO_SIDED|95.0|0.96|1.01|||Regression, Logistic|Bonferroni-adjusted alpha=0.01 (for 5 comparisons)|GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||1.01|0.96|0.13
71095987|NCT02021318|141700463|SUPERIORITY||LSM Difference|-0.03||||0.709|TWO_SIDED|95.0|-0.19|0.129|||Mixed Models Analysis|||Week 22- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.129|-0.190|0.709
71095988|NCT02021318|141700463|SUPERIORITY||LSM Difference|-0.061||||0.45|TWO_SIDED|95.0|-0.219|0.097|||Mixed Models Analysis|||Week 24- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.097|-0.219|0.450
70977556|NCT02928952|141463371|SUPERIORITY|Assessed group by time differences from week 12 to week 24. Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.153|||||||Mixed Models Analysis|All models adjusted for Age and Duration of Diabetes||The statistical analysis was applied to both groups.||||0.153
70977557|NCT02928952|141463371|SUPERIORITY|Assessed group by time differences from week 12 to week 24. Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.026|||||||Mixed Models Analysis|Adjusted for age and duration of diabetes.||||||0.026
70977558|NCT02928952|141463371|SUPERIORITY|Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.012|||||||Mixed Models Analysis|Models adjusted for age and duration of diabetes.||Within group analysis of intervention effect on Diabetes Distress (Problem Areas in Diabetes, PAID scale) over time stratified by hemoglobin A1c\<8.5% and =/\>8.5.||||0.012
70977559|NCT02928952|141463372|SUPERIORITY|The statistical analysis was applied to both groups.||||||0.604|||||||Mixed Models Analysis|All models adjusted for age and duration of diabetes.||Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||.604
70977560|NCT02928952|141463373|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.911|||||||Mixed Models Analysis|All models adjusted for Age and Duration of Diabetes||The statistical analysis was applied to both groups.||||0.911
70977561|NCT02928952|141463374|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.94|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||||||0.940
70977562|NCT02928952|141463375|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.305|||||||Mixed Models Analysis|All models adjusted for Age and Duration of Diabetes||The statistical analysis was applied to both groups.||||0.305
70977563|NCT02928952|141463376|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.228|||||||Mixed Models Analysis|All models adjusted for age and duration of diabetes.||||||0.228
70977564|NCT02928952|141463377|SUPERIORITY|Statistical Test of hypothesis. Differing sample sizes are due to attrition and missed research visits. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.671|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.671
70977565|NCT02928952|141463378|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.571|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.571
70977566|NCT02928952|141463379|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.003|||||||Mixed Models Analysis|All models adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.003
70977567|NCT02928952|141463380|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.632|||||||Mixed Models Analysis|All models adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.632
70977568|NCT02928952|141463381|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.219|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.219
70977569|NCT02928952|141463382|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.931|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.931
70977570|NCT02928952|141463383|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.627|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.627
70977571|NCT02928952|141463384|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.6|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.60
70977572|NCT02928952|141463385|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.461|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.461
70977573|NCT02928952|141463386|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.906|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.906
70977574|NCT02928952|141463387|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.856|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.856
70977575|NCT02928952|141463388|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.89|||||||Mixed Models Analysis|All models adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.89
71095989|NCT02021318|141700463|SUPERIORITY||LSM Difference|-0.065||||0.44|TWO_SIDED|95.0|-0.231|0.101|||Mixed Models Analysis|||Week 28- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.101|-0.231|0.440
70977576|NCT00723957|141463393|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04|||||ONE_SIDED|90.0||1.41|||Regression, Cox|||||1.41||
70977577|NCT00723957|141463393|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5735|||||||Log Rank|||P-value is 1-sided||||0.5735
70977578|NCT00723957|141463394|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78|||||ONE_SIDED|90.0||1.1|||Regression, Cox|||||1.10||
70977579|NCT00723957|141463394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.175|||||||Log Rank|||P-value is 1-sided||||0.1750
70977580|NCT00723957|141463395|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92|||||ONE_SIDED|90.0||1.15|||Regression, Cox|||||1.15||
70977581|NCT00723957|141463395|SUPERIORITY_OR_OTHER_LEGACY|||||||0.316|ONE_SIDED||||||Log Rank|||P-value is 1-sided||||0.316
70977582|NCT00723957|141463401|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.6|||||ONE_SIDED|90.0||2.1|||Regression, Cox||β3T+ subgroup|||2.10||
70977583|NCT00723957|141463401|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||||ONE_SIDED|90.0||0.9|||Regression, Cox||β3T- subgroup|||0.90||
70977584|NCT00723957|141463401|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.1|||||ONE_SIDED|90.0||1.4|||Regression, Cox||Overall population|||1.40||
70977585|NCT00706628|141463404|SUPERIORITY_OR_OTHER|||||||0.0577|||||||Fisher Exact|||||||0.0577
70977586|NCT00706628|141463404|SUPERIORITY_OR_OTHER|||||||0.0863|||||||Fisher Exact|||||||0.0863
70977587|NCT00706628|141463406|SUPERIORITY_OR_OTHER||Slope|1.4823|STANDARD_ERROR_OF_MEAN|0.149|||TWO_SIDED|95.0|1.1754|1.7892||||||||1.7892|1.1754|
70977588|NCT01264939|141463418|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.52|||<|0.0001|TWO_SIDED|95.0|-5.97|-3.08||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-3.08|-5.97|<0.0001
70977589|NCT01264939|141463419|SUPERIORITY_OR_OTHER||Least squares mean difference|-10.02|||<|0.0001|TWO_SIDED|95.0|-13.17|-6.86||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-6.86|-13.17|<0.0001
70977590|NCT01264939|141463420|SUPERIORITY_OR_OTHER||Least squares mean difference|-5.9|||<|0.0001|TWO_SIDED|95.0|-7.72|-4.07||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-4.07|-7.72|<0.0001
70977591|NCT01264939|141463421|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.99|||<|0.0001|TWO_SIDED|95.0|1.47|2.68||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||2.68|1.47|<0.0001
70977592|NCT01264939|141463422|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
70977593|NCT01264939|141463423|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
70977594|NCT01264939|141463424|SUPERIORITY_OR_OTHER||Least squares mean difference|-5.61|||<|0.0001|TWO_SIDED|95.0|-7.25|-3.96||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-3.96|-7.25|<0.0001
70977595|NCT01264939|141463425|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.67|||<|0.0001|TWO_SIDED|95.0|-6.28|-3.06||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-3.06|-6.28|<0.0001
70977596|NCT01264939|141463426|SUPERIORITY_OR_OTHER|||||||0.0006||95.0||||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||0.0006
70977597|NCT01264939|141463427|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
70977598|NCT01957137|141463597|SUPERIORITY_OR_OTHER|||||||0.3773|||||||Mixed Models Analysis|The final model included cycling, period and the interaction between cycling and period.||||||0.3773
70977599|NCT01957137|141463598|SUPERIORITY_OR_OTHER|||||||0.2396|||||||Mixed Models Analysis|The final model included cycling and period.||||||0.2396
70977600|NCT01957137|141463599|SUPERIORITY_OR_OTHER|||||||0.8874|||||||Mixed Models Analysis|The final model included cycling and period.||||||0.8874
70977601|NCT01656772|141463626|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin d = -0.05. The null hypothesis was to be rejected if Z \> 1.645 or, equivalently, if the corresponding p-value was less than 0.05.||||||0.0405|TWO_SIDED|||||Adjusted to take into account the correlation between multiple PVs on the same subject. The sample estimate of the intraclass correlation coefficient was calculated as the Pearson sample correlation coefficient for all pairs of observations.|Farrington and Manning|||The primary effectiveness endpoint is the successful navigation and EGM recording of each pre-specified pulmonary vein (PV). The RF ablation treatment was not part of the investigational procedure. The null hypothesis was to be tested at the α = 0.05 significance level using a test statistic Z based on the Farrington and Manning likelihood score statistic with adjustment to take into account the correlation between multiple observations (PVs) on the same subject.||||0.0405
70977602|NCT01656772|141463627|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin d= 0.07. The one-sided null hypothesis was to be tested at the α = 0.05 significance level using a standard unpooled asymptotically normal test statistic. The null hypothesis was to be rejected if Z \< -1.7046 or, equivalently, if the corresponding p-value was less than 0.05.||||||0.0441|TWO_SIDED||||||Z-statistic|||||||.0441
71095990|NCT02021318|141700463|SUPERIORITY||LSM Difference|0.014||||0.874|TWO_SIDED|95.0|-0.157|0.184|||Mixed Models Analysis|||Week 32- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.184|-0.157|0.874
71095991|NCT02021318|141700463|SUPERIORITY||LSM Difference|0.131||||0.132|TWO_SIDED|95.0|-0.039|0.302|||Mixed Models Analysis|||Week 36- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.302|-0.039|0.132
71095992|NCT02021318|141700463|SUPERIORITY||LSM Difference|0.187||||0.024|TWO_SIDED|95.0|0.024|0.351|||Mixed Models Analysis|||Week 40- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.351|0.024|0.024
70922365|NCT05644002|141335675|OTHER||Mean Difference (Final Values)|-0.543||||0.001|TWO_SIDED|95.0|-0.772|-0.314||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \< .05, equal variances are not assumed and reported results are adjusted accordingly.||An independent samples t-test was conducted to examine differences in post-stress-induction average puff duration between PTBT and Control conditions.||-.314|-.772|.001
70922366|NCT05644002|141335675|OTHER||t-statistic|-4.739|||||TWO_SIDED||||||t-test, 2 sided|degrees freedom = 66.03||An independent samples t-test was conducted to examine differences in post-stress-induction average puff duration between PTBT and Control conditions.||||
70922367|NCT05644002|141335675|OTHER||Hedge's g|-1.05|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction average puff duration between the PTBT and Control conditions.||||
70922368|NCT03547908|141335694|NON_INFERIORITY|A sample size of 240 participants randomized in a 1:1 ratio to 2 treatment groups, achieved 90% power to detect a non-inferiority margin of 12% between the 2 treatment groups. For the sample size and power computation, it is assumed that both treatment groups have a response rate of 91% (based on Gilead Studies GS-US-380-1489 and GS-US-380-1490), that the non-inferiority margin is 12%, and that the significance level of the test is at a one-sided 0.025 level.|Difference in Percentages|4.1|||||TWO_SIDED|95.001|-2.5|10.8|||||The difference in percentages of participants between groups and their 95.001% confidence intervals (CI)s were calculated based on Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL).|||10.8|-2.5|
70922369|NCT03547908|141335694|SUPERIORITY|||||||0.2113|||||||Cochran-Mantel-Haenszel|The p-value was calculated from Cochran-Mantel-Haenszel (CMH) test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL).||||||0.2113
70922370|NCT03547908|141335695|NON_INFERIORITY|A sample size of 240 participants provided 81% power to detect a non-inferiority margin of 12% between the 2 treatment groups. This assumed that both treatment groups have a response rate of 88% (based on Gilead Studies GS-US-320-0108 and GS-US-320-0110), that the non-inferiority margin is 12%, and that the significance level of the test is at a one-sided 0.025 level.|Difference in Percentages|16.6|||||TWO_SIDED|95.001|5.9|27.3|||||||The difference in percentages of participants with HBV DNA \< 29 IU/mL between treatment groups and its 95.001% CI were calculated based on the MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA category (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|27.3|5.9|
70977603|NCT01795547|141463665|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the primary endpoint was considered confirmed if the lower bound of the 2-sided 95% CI at Week 28 was \> -5 or equivalently if the p-value for the 1-sided test of H0: D ≤ -5 against H1: D \> -5 was ≤2.5%, where D was the mean treatment difference (aripiprazole minus paliperidone). Superiority was then tested as pre-specified with the FAS and demonstrated for aripiprazole over paliperidone, since the lower bound of the 95% CI was \>0.|Least Squares Mean Difference|4.666||||0.036|TWO_SIDED|95.0|0.316|9.015|||Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||Comparison of aripiprazole versus paliperidone was made using estimates from a mixed model for repeated measurements (MMRM) using an unstructured covariance matrix.||9.015|0.316|0.036
70977604|NCT01795547|141463666|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.492||||0.043|TWO_SIDED|95.0|-2.935|-0.049||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||-0.049|-2.935|0.043
71095993|NCT02021318|141700463|SUPERIORITY||LSM Difference|0.022||||0.807|TWO_SIDED|95.0|-0.153|0.197|||Mixed Models Analysis|||Week 44- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.197|-0.153|0.807
70977605|NCT01795547|141463667|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.283||||0.004|TWO_SIDED|95.0|-0.477|-0.09||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||-0.090|-0.477|0.004
71095994|NCT02021318|141700463|SUPERIORITY||LSM Difference|0.012||||0.89|TWO_SIDED|95.0|-0.16|0.185|||Mixed Models Analysis|||Week 48- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.185|-0.160|0.890
70977606|NCT01795547|141463668|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.331||||0.149|TWO_SIDED|95.0|-0.12|0.782||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||0.782|-0.120|0.149
70977607|NCT01795547|141463669|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.753||||0.039|TWO_SIDED|95.0|0.093|3.412||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||3.412|0.093|0.039
70977608|NCT01795547|141463670|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.764||||0.07|TWO_SIDED|95.0|-0.143|3.672||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||3.672|-0.143|0.070
70977609|NCT01795547|141463671|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.922||||0.13|TWO_SIDED|95.0|-0.275|2.119||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||2.119|-0.275|0.130
70977610|NCT01795547|141463672|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.007||||0.561|TWO_SIDED|95.0|-2.402|4.417||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||4.417|-2.402|0.561
70977611|NCT01795547|141463673|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.695||||0.095|TWO_SIDED|95.0|-1.511|0.121||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||0.121|-1.511|0.095
70977612|NCT02116621|141463699|SUPERIORITY||Adjusted difference in differences|-1.36|||||TWO_SIDED|95.0|-2.91|0.19|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|||0.19|-2.91|
70977613|NCT02116621|141463700|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: -0.79 (-2.37 to 0.80); baseline to 26 weeks: -1.36 (-2.91 to 0.19); baseline to 52 weeks: 0.16 (-1.47 to 1.79)|||0.21
70977614|NCT02116621|141463701|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 0.31 (-1.18 to 1.81); baseline to 26 weeks: -1.41 (-2.87 to 0.06); baseline to 52 weeks: -1.24 (-2.77 to 0.30)|||0.06
70977615|NCT02116621|141463702|SUPERIORITY|||||||0.35|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks:-0.66 (-2.55 to 1.24); baseline to 26 weeks: 0.93 (-0.92 to 2.79); baseline to 52 weeks: 0.76 (-1.19 to 2.70)|||0.35
70977616|NCT02116621|141463703|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 0.30 (-1.01 to 1.61); baseline to 26 weeks: -0.17 (-1.45 to 1.12); baseline to 52 weeks: -0.26 (-1.61 to 1.09)|||0.86
70977617|NCT02116621|141463704|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 1.05 (-2.54 to 4.64); baseline to 26 weeks: 1.90 (-1.66 to 5.47); baseline to 52 weeks: 0.08 (-3.61 to 3.77).|||0.70
70977618|NCT02116621|141463705|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 4.24 (-2.73 to 11.20); baseline to 26 weeks: 4.64 (-2.25 to 11.54); baseline to 52 weeks: -1.91 (-9.07 to 5.26).|||0.20
70977619|NCT02116621|141463706|SUPERIORITY|||||||0.66|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 1.76 (-2.37 to 5.89); baseline to 26 weeks: 2.55 (-1.50 to 6.60); baseline to 52 weeks: 1.53 (-2.70 to 5.77).|||0.66
70977620|NCT02116621|141463707|SUPERIORITY|||||||0.44|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 7.77 (-2.87 to 18.42); baseline to 26 weeks: 7.29 (-3.16 to 17.75); baseline to 52 weeks: 4.13 (-6.81 to 15.07).|||0.44
70977621|NCT02116621|141463708|SUPERIORITY|||||||0.58|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 2.15 (-2.84 to 7.13); baseline to 26 weeks: 3.31 (-1.57 to 8.19); baseline to 52 weeks: 1.00 (-4.11 to 6.11).|||0.58
70977622|NCT02116621|141463709|SUPERIORITY|||||||0.73|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 1.81 (-4.41 to 8.02); baseline to 26 weeks: -1.57 (-7.68 to 4.54); baseline to 52 weeks: 1.11 (-5.27 to 7.48).|||0.73
70977623|NCT02116621|141463710|SUPERIORITY||Adjusted difference in differences|-1.41|||||TWO_SIDED|95.0|-2.87|0.06|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|||0.06|-2.87|
70977624|NCT02116621|141463711|SUPERIORITY||Adjusted difference in differences|0.93|||||TWO_SIDED|95.0|-0.92|2.79|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|2.79|-0.92|
70977625|NCT02116621|141463712|SUPERIORITY||Adjusted difference in differences|-0.17|||||TWO_SIDED|95.0|-1.45|1.12|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|1.12|-1.45|
70977626|NCT02116621|141463713|SUPERIORITY||Adjusted difference in differences|1.9|||||TWO_SIDED|95.0|-1.66|5.47|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|5.47|-1.66|
70977627|NCT02116621|141463714|SUPERIORITY||Adjusted difference in differences|4.64|||||TWO_SIDED|95.0|-2.25|11.54|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|11.54|-2.25|
70977628|NCT02116621|141463715|SUPERIORITY||Adjusted difference in differences|2.55|||||TWO_SIDED|95.0|-1.5|6.6|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|6.60|-1.50|
71095995|NCT02021318|141700463|SUPERIORITY||LSM Difference|-0.029||||0.746|TWO_SIDED|95.0|-0.201|0.144|||Mixed Models Analysis|||Week 52- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.144|-0.201|0.746
70977629|NCT02116621|141463716|SUPERIORITY||Adjusted difference in differences|7.29|||||TWO_SIDED|95.0|-3.16|17.75|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|17.75|-3.16|
70977630|NCT02116621|141463717|SUPERIORITY||Adjusted difference in differences|3.31|||||TWO_SIDED|95.0|-1.57|8.19|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|8.19|-1.57|
70977631|NCT02116621|141463718|SUPERIORITY||Adjusted difference in differences|-1.57|||||TWO_SIDED|95.0|-7.68|4.54|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|4.54|-7.68|
70977632|NCT02116621|141463719|SUPERIORITY||Mean Difference (Final Values)|11.9||||0.01|TWO_SIDED|95.0|2.59|21.24|||Regression, Linear|||||21.24|2.59|0.01
70977633|NCT02116621|141463720|SUPERIORITY||Adjusted difference in differences|-0.79|||||TWO_SIDED|95.0|-2.37|0.8|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||0.80|-2.37|
70977634|NCT02116621|141463721|SUPERIORITY||Adjusted difference in differences|0.31|||||TWO_SIDED|95.0|-1.18|1.81|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||1.81|-1.18|
70977635|NCT02116621|141463722|SUPERIORITY||Adjusted difference in differences|0.3|||||TWO_SIDED|95.0|-1.01|1.61|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||1.61|-1.01|
70977636|NCT02116621|141463723|SUPERIORITY||Adjusted difference in differences|-0.66|||||TWO_SIDED|95.0|-2.55|1.24|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||1.24|-2.55|
70977637|NCT02116621|141463724|SUPERIORITY||Adjusted difference in differences|1.05|||||TWO_SIDED|95.0|-2.54|4.64|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||4.64|-2.54|
70977638|NCT02116621|141463725|SUPERIORITY||Adjusted difference in differences|4.24|||||TWO_SIDED|95.0|-2.73|11.2|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||11.20|-2.73|
70977639|NCT02116621|141463726|SUPERIORITY||Adjusted difference in differences|1.76|||||TWO_SIDED|95.0|-2.37|5.89|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||5.89|-2.37|
70977640|NCT02116621|141463727|SUPERIORITY||Adjusted difference in differences|7.77|||||TWO_SIDED|95.0|-2.87|18.42|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||18.42|-2.87|
70977641|NCT02116621|141463728|SUPERIORITY||Adjusted difference in differences|2.15|||||TWO_SIDED|95.0|-2.84|7.13|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||7.13|-2.84|
70977642|NCT02116621|141463729|SUPERIORITY||Adjusted difference in differences|1.81|||||TWO_SIDED|95.0|-4.41|8.02|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||8.02|-4.41|
70977643|NCT02116621|141463730|SUPERIORITY||Adjusted difference in differences|0.16|||||TWO_SIDED|95.0|-1.47|1.79|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||1.79|-1.47|
70977644|NCT02116621|141463731|SUPERIORITY||Adjusted difference in differences|-1.24|||||TWO_SIDED|95.0|-2.77|0.3|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||0.30|-2.77|
70977645|NCT02116621|141463732|SUPERIORITY||Adjusted difference in differences|-0.26|||||TWO_SIDED|95.0|-1.61|1.09|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||1.09|-1.61|
70977646|NCT02116621|141463733|SUPERIORITY||Adjusted difference in differences|0.76|||||TWO_SIDED|95.0|-1.19|2.7|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||2.70|-1.19|
70977647|NCT02116621|141463734|SUPERIORITY||Adjusted difference in differences|0.08|||||TWO_SIDED|95.0|-3.61|3.77|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||3.77|-3.61|
70977648|NCT02116621|141463735|SUPERIORITY||Adjusted difference in differences|-1.91|||||TWO_SIDED|95.0|-9.07|5.26|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||5.26|-9.07|
70977649|NCT02116621|141463736|SUPERIORITY||Adjusted difference in differences|1.53|||||TWO_SIDED|95.0|-2.7|5.77|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||5.77|-2.70|
70977650|NCT02116621|141463737|SUPERIORITY||Adjusted difference in differences|4.13|||||TWO_SIDED|95.0|-6.81|15.07|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||15.07|-6.81|
70977651|NCT02116621|141463738|SUPERIORITY||Adjusted difference in differences|1.0|||||TWO_SIDED|95.0|-4.11|6.11|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||6.11|-4.11|
70977652|NCT02116621|141463739|SUPERIORITY||Adjusted difference in differences|1.11|||||TWO_SIDED|95.0|-5.27|7.48|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||7.48|-5.27|
70977653|NCT02116621|141463740|SUPERIORITY||Mean Difference (Final Values)|9.41||||0.054|TWO_SIDED|95.0|-0.15|18.96|||Regression, Linear|||||18.96|-0.15|0.054
70977654|NCT02764541|141463761|EQUIVALENCE|The hypothesis is that there is no difference in anti-proliferative activity of Letrozole vs Tamoxifen by measuring the fold-change in percent Ki67 from baseline to day15 in log scale within hormone receptor positive breast cancer patients with invasive ductal carcinoma||||||0.0045|||||||Wilcoxon (Mann-Whitney)|||||||0.0045
71095996|NCT02021318|141700463|SUPERIORITY||LSM Difference|-0.032||||0.715|TWO_SIDED|95.0|-0.202|0.139|||Mixed Models Analysis|||Week 56- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.139|-0.202|0.715
71095997|NCT02021318|141700463|SUPERIORITY||LSM Difference|0.066||||0.463|TWO_SIDED|95.0|-0.11|0.242|||Mixed Models Analysis|||Week 60- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.242|-0.110|0.463
71095998|NCT02021318|141700463|SUPERIORITY||LSM Difference|-0.002||||0.987|TWO_SIDED|95.0|-0.187|0.184|||Mixed Models Analysis|||Week 64- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.184|-0.187|0.987
71095999|NCT02021318|141700463|SUPERIORITY||LSM Difference|0.104||||0.251|TWO_SIDED|95.0|-0.074|0.281|||Mixed Models Analysis|||Week 68- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.281|-0.074|0.251
71096000|NCT02021318|141700463|SUPERIORITY||LSM Difference|0.067||||0.473|TWO_SIDED|95.0|-0.117|0.251|||Mixed Models Analysis|||Week 72- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.251|-0.117|0.473
71096001|NCT02021318|141700463|SUPERIORITY||LSM Difference|-0.022||||0.813|TWO_SIDED|95.0|-0.204|0.16|||Mixed Models Analysis|||Week 76- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.160|-0.204|0.813
71096002|NCT02021318|141700463|SUPERIORITY||LSM Difference|-0.045||||0.622|TWO_SIDED|95.0|-0.223|0.134|||Mixed Models Analysis|||Week 80- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.134|-0.223|0.622
70977655|NCT02764541|141463761|EQUIVALENCE|The hypothesis is that there is no difference in anti-proliferative activity of Letrozole vs Tamoxifen by measuring the fold-change in percent Ki67 from baseline to day15 in log scale within hormone receptor positive breast cancer patients with invasive lobular carcinoma||||||0.0161|||||||Wilcoxon (Mann-Whitney)|||||||0.0161
70977656|NCT02764541|141463762|EQUIVALENCE|The hypothesis is that there is no difference of pathologic response measured by RCB index between Arm C and Arm D||||||0.9288|||||||Wilcoxon (Mann-Whitney)|||||||0.9288
70977657|NCT02764541|141463764|EQUIVALENCE|The hypothesis is that there is no difference of pathologic response measured by RCB index between Arm C and Arm D|Mean Difference (Final Values)|0.02||||0.92|TWO_SIDED|95.0|-0.29|0.32|||Regression, Linear|||||0.32|-0.29|0.920
71096003|NCT02021318|141700463|SUPERIORITY||LSM Difference|0.045||||0.632|TWO_SIDED|95.0|-0.138|0.227|||Mixed Models Analysis|||Week 84- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.227|-0.138|0.632
71096004|NCT02021318|141700463|SUPERIORITY||LSM Difference|0.055||||0.568|TWO_SIDED|95.0|-0.133|0.242|||Mixed Models Analysis|||Week 88- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.242|-0.133|0.568
70977658|NCT02764541|141463765|EQUIVALENCE|The hypothesis is that there is no difference of RCB response rate between Arm C and Arm D||||||0.758|||||||Fisher Exact|||||||0.758
70977659|NCT00749190|141463767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.1||0.0226|TWO_SIDED|95.0|-0.44|-0.03||P-values are regarded as descriptive, adjustment for multiple testing was not necessary.|ANCOVA|Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.|Difference calculated as empagliflozin 1 mg minus placebo|||-0.03|-0.44|0.0226
71096005|NCT02021318|141700463|SUPERIORITY||LSM Difference|0.034||||0.729|TWO_SIDED|95.0|-0.158|0.226|||Mixed Models Analysis|||Week 92- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.226|-0.158|0.729
71096006|NCT02021318|141700463|SUPERIORITY||LSM Difference|0.025||||0.797|TWO_SIDED|95.0|-0.168|0.218|||Mixed Models Analysis|||Week 96- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.218|-0.168|0.797
71096007|NCT02021318|141700463|SUPERIORITY||LSM Difference|-0.11||||0.28|TWO_SIDED|95.0|-0.31|0.09|||Mixed Models Analysis|||Week 100- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.090|-0.310|0.280
71096008|NCT02021318|141700463|SUPERIORITY||LSM Difference|0.037||||0.733|TWO_SIDED|95.0|-0.177|0.251|||Mixed Models Analysis|||Week 104- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.251|-0.177|0.733
71096009|NCT02021318|141700464|SUPERIORITY||LSM Difference|0.026||||0.727|TWO_SIDED|95.0|-0.119|0.17|||Mixed Models Analysis|||Weeks 28-36 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.170|-0.119|0.727
71096010|NCT02021318|141700464|SUPERIORITY||LSM Difference|-0.001||||0.985|TWO_SIDED|95.0|-0.151|0.148|||Mixed Models Analysis|||Weeks 44-52 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.148|-0.151|0.985
70977660|NCT00749190|141463767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.1||0.0002|TWO_SIDED|95.0|-0.59|-0.18||P-values are regarded as descriptive, adjustment for multiple testing was not necessary.|ANCOVA|Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.|Difference calculated as empagliflozin 5 mg minus placebo|||-0.18|-0.59|0.0002
70977661|NCT00749190|141463767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.91|-0.51||P-values are regarded as descriptive, adjustment for multiple testing was not necessary.|ANCOVA|Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.|Difference calculated as empagliflozin 10 mg minus placebo|||-0.51|-0.91|<0.0001
71096011|NCT02021318|141700464|SUPERIORITY||LSM Difference|0.003||||0.965|TWO_SIDED|95.0|-0.148|0.154|||Mixed Models Analysis|||Weeks 72-80 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.154|-0.148|0.965
70977662|NCT00749190|141463767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.91|-0.5||P-values are regarded as descriptive, adjustment for multiple testing was not necessary.|ANCOVA|Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.|Difference calculated as empagliflozin 25 mg minus placebo|||-0.50|-0.91|<0.0001
70977663|NCT00749190|141463767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.84|-0.43||P-values are regarded as descriptive, adjustment for multiple testing was not necessary.|ANCOVA|Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.|Difference calculated as empagliflozin 50 mg minus placebo|||-0.43|-0.84|<0.0001
70977664|NCT00630331|141463815|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|83.8|||<|0.001|ONE_SIDED|97.5|61.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||61.0|<0.001
70977665|NCT00630331|141463815|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|88.2|||<|0.001|ONE_SIDED|97.5|67.4|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||67.4|<0.001
70977666|NCT00630331|141463815|SUPERIORITY_OR_OTHER_LEGACY|||||||0.999||97.5||||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|For strain A/H3N2, the vaccine efficacy of the CCI vaccine vs. placebo was not evaluable since no influenza case was observed in the placebo group.||Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H3N2 strain. Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.||||0.999
70977667|NCT00630331|141463815|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|100.0||||0.394|ONE_SIDED|97.5|-410.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||-410|0.394
70977668|NCT00630331|141463815|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|78.4||||0.004|ONE_SIDED|97.5|52.1|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||52.1|0.004
70977669|NCT00630331|141463815|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|80.3||||0.002|ONE_SIDED|97.5|54.7|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||54.7|0.002
70977670|NCT00630331|141463815|SUPERIORITY_OR_OTHER_LEGACY|||||||0.992||97.5||||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|For strain A/H3N2, the vaccine efficacy of the IVV vaccine vs. placebo was not evaluable since no influenza case was observed in the placebo group.||Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H3N2 strain. Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.||||0.992
70977671|NCT00630331|141463815|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|100.0||||0.4|ONE_SIDED|97.5|-429.4|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||-429.4|0.400
71096012|NCT02021318|141700464|SUPERIORITY||LSM Difference|-0.016||||0.856|TWO_SIDED|95.0|-0.188|0.157|||Mixed Models Analysis|||Weeks 96-104 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.157|-0.188|0.856
71034392|NCT00796653|141578349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.071|0.152|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.152|0.071|<0.0001
71034393|NCT00796653|141578349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.086|0.166|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.166|0.086|<0.0001
71034394|NCT00796653|141578349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.078|0.158|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.158|0.078|<0.0001
71034395|NCT00796653|141578350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.231|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.162|0.299|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.299|0.162|<0.0001
71034396|NCT00796653|141578350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.182|0.318|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.318|0.182|<0.0001
71096013|NCT02021318|141700466|SUPERIORITY||Hazard Ratio (HR)|1.74|||<|0.001|TWO_SIDED|95.0|1.36|2.22|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and Region and adjusting on Hb and eGFR at baseline as continuous covariates.||2.22|1.36|<0.001
70922371|NCT03547908|141335695|SUPERIORITY|||||||0.0023|||||||Cochran-Mantel-Haenszel|The p-value was from CMH test stratified by baseline HBeAg status (positive vs negative) and HBV DNA category (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).||||||0.0023
70922372|NCT03547908|141335696|SUPERIORITY||Difference in Percentages|-0.3||||0.9427|TWO_SIDED|95.0|-8.9|8.3||P-value for the superiority test comparing the percentages of participants with HIV-1 RNA \< 50 copies/mL between treatment groups was from the CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentages of participants with HIV-1 RNA \< 50 copies/mL between treatment groups and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||8.3|-8.9|0.9427
70922373|NCT03547908|141335697|OTHER||Difference in least squares mean (LSM)|24.0||||0.1701|TWO_SIDED|95.0|-10.0|58.0|||ANOVA|The p-value was calculated using ANOVA model adjusted by the baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL).|The difference in least squares means and its 95% CI were calculated using ANOVA model adjusted by the baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL).|||58|-10|0.1701
71034397|NCT00796653|141578350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.266|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.198|0.334|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.334|0.198|<0.0001
71034398|NCT00796653|141578351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.182|0.32|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.320|0.182|<0.0001
71034399|NCT00796653|141578351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.249|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.18|0.318|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.318|0.180|<0.0001
71034400|NCT00796653|141578351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.281|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.212|0.35|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.350|0.212|<0.0001
71034401|NCT00796653|141578352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.229|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.159|0.299|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.299|0.159|<0.0001
70977672|NCT00630331|141463816|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|58.7||||0.078|ONE_SIDED|97.5|33.5|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||33.5|0.078
70977673|NCT00630331|141463816|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|87.3||||0.104|ONE_SIDED|97.5|4.6|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||4.6|0.104
70977674|NCT00630331|141463816|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|100.0||||0.03|ONE_SIDED|97.5|36.3|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H3N2 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||36.3|0.030
70977675|NCT00630331|141463816|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|50.0||||0.376|ONE_SIDED|97.5|17.5|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||17.5|0.376
71008751|NCT02055976|141525250|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.034|STANDARD_ERROR_OF_MEAN|9.553||0.799|TWO_SIDED|95.0|-10.948|27.015|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||27.015|-10.948|0.799
71096014|NCT02021318|141700469|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.079|TWO_SIDED|95.0|0.98|1.5|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and Region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI is below 1.0.||1.50|0.98|0.079
71096015|NCT02021318|141700470|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.3|TWO_SIDED|95.0|0.79|2.11|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI is below 1.0.||2.11|0.79|0.300
71096016|NCT02021318|141700474|SUPERIORITY||Hazard Ratio (HR)|1.59||||0.055|TWO_SIDED|95.0|0.99|2.54|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and Region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI is below 1.0.||2.54|0.99|0.055
71096017|NCT02021318|141700477|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.052|TWO_SIDED|95.0|0.51|1.0|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI is below 1.0.||1.00|0.51|0.052
71096018|NCT02021318|141700487|SUPERIORITY||LSM Difference|-1.068||||0.027|TWO_SIDED|95.0|-2.012|-0.124|||Mixed Models Analysis|||Weeks 12-28 - The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline SF-36 PCS, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||-0.124|-2.012|0.027
71096019|NCT02021318|141700487|SUPERIORITY||LSM Difference|-0.603||||0.239|TWO_SIDED|95.0|-1.606|0.401|||Mixed Models Analysis|||Weeks 36-52 - The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline SF-36 PCS, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||0.401|-1.606|0.239
71096020|NCT02021318|141700488|SUPERIORITY||LSM Difference|-0.528||||0.517|TWO_SIDED|95.0|-2.127|1.072|||Mixed Models Analysis|||Weeks 12-28 - The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline FACT-An AnS, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||1.072|-2.127|0.517
71096021|NCT02021318|141700488|SUPERIORITY||LSM Difference|-0.947||||0.308|TWO_SIDED|95.0|-2.771|0.877|||Mixed Models Analysis|||Weeks 36-52 - The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline FACT-An AnS, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||0.877|-2.771|0.308
71096022|NCT02021318|141700489|SUPERIORITY||LSM Difference|-0.904||||0.57|TWO_SIDED|95.0|-4.032|2.224|||Mixed Models Analysis|||Week 12-28 - The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline FACT-An total score, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||2.224|-4.032|0.570
71096023|NCT02021318|141700489|SUPERIORITY||LSM Difference|-1.767||||0.334|TWO_SIDED|95.0|-5.354|1.82|||Mixed Models Analysis|||Weeks 36-52 -The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline FACT-An total score, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||1.820|-5.354|0.334
71096024|NCT02021318|141700491|SUPERIORITY||LSM Difference|0.784||||0.497|TWO_SIDED|95.0|-1.481|3.049|||Mixed Models Analysis|||The model includes treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline EQ-5D 5L VAS, baseline Hb, baseline eGFR as continuous covariates.||3.049|-1.481|0.497
71096025|NCT02021318|141700502|SUPERIORITY||LSM Difference|-0.05||||0.902|TWO_SIDED|95.0|-0.93|0.82|||Mixed Models Analysis|||||0.82|-0.93|0.902
71096026|NCT02021318|141700504|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.96|TWO_SIDED|95.0|0.79|1.29|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.29|0.79|0.960
71096027|NCT02021318|141700506|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.939|TWO_SIDED|95.0|0.79|1.25|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.25|0.79|0.939
71096028|NCT02021318|141700507|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.948|TWO_SIDED|95.0|0.77|1.27|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.27|0.77|0.948
71096029|NCT02021318|141700508|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.568|TWO_SIDED|95.0|0.75|1.17|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.17|0.75|0.568
71096030|NCT00441896|141700578|SUPERIORITY|||||||0.7391|||||||ANCOVA|||||||0.7391
71096031|NCT00441896|141700578|SUPERIORITY|||||||0.537|||||||ANCOVA|||||||0.5370
71096032|NCT00441896|141700578|SUPERIORITY|||||||0.908|||||||ANCOVA|||||||0.9080
71096033|NCT00441896|141700578|SUPERIORITY|||||||0.2539|||||||ANCOVA|||||||0.2539
70977676|NCT00630331|141463816|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|58.6||||0.085|ONE_SIDED|97.5|32.9|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||32.9|0.085
70977677|NCT00630331|141463816|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|100.0||||0.033|ONE_SIDED|97.5|33.9|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||33.9|0.033
70977678|NCT00630331|141463816|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|73.6||||0.265|ONE_SIDED|97.5|-30.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H3N2 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||-30.0|0.265
70977679|NCT00630331|141463816|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|51.7||||0.319|ONE_SIDED|97.5|19.4|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||19.4|0.319
70977680|NCT00630331|141463817|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|69.5|||<|0.001|ONE_SIDED|97.5|55.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||55.0|<0.001
70977681|NCT00630331|141463817|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|89.3|||<|0.001|ONE_SIDED|97.5|73.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||73.0|<0.001
70977682|NCT00630331|141463817|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|75.6||||0.04|ONE_SIDED|97.5|35.1|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H3N2 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||35.1|0.040
71096034|NCT00441896|141700578|SUPERIORITY|||||||0.6657|||||||ANCOVA|||||||0.6657
70977683|NCT00630331|141463817|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|49.9||||0.37|ONE_SIDED|97.5|18.2|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||18.2|0.37
71034402|NCT00796653|141578352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.247|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.177|0.317|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.317|0.177|<0.0001
71034403|NCT00796653|141578352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.275|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.205|0.345|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.345|0.205|<0.0001
71034404|NCT00796653|141578353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.199|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.128|0.27|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.270|0.128|<0.0001
71034405|NCT00796653|141578353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.142|0.283|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.283|0.142|<0.0001
71034406|NCT00796653|141578353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.241|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.17|0.312|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.312|0.170|<0.0001
71034407|NCT00796653|141578354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.146|0.29|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.290|0.146|<0.0001
70977684|NCT00630331|141463817|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|63.0||||0.003|ONE_SIDED|97.5|46.7|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||46.7|0.003
70977685|NCT00630331|141463817|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|81.5|||<|0.001|ONE_SIDED|97.5|60.9|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||60.9|<0.001
70977686|NCT00630331|141463817|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|49.3||||0.53|ONE_SIDED|97.5|-9.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H3N2 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||-9.0|0.53
70977687|NCT00630331|141463817|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|53.2||||0.26|ONE_SIDED|97.5|22.2|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||22.2|0.26
70977688|NCT01565980|141463844|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P-values for the comparison of least square (LS) means represent the effect of the trial arm. The effect sizes are calculated as Cohen's d: difference between LS means divided by the standard deviation.|Mixed Models Analysis|||The outcome measure was analyzed using linear mixed effects models (LME). The main effect of the trial arm was evaluated by averaging time 2 and time 3 values of the outcomes within the LME model. The resulting least square (LS) means and their standard errors are reported.||||<.05
71034408|NCT00796653|141578354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.237|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.166|0.309|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.309|0.166|<0.0001
71034409|NCT00796653|141578354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.148|0.292|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.292|0.148|<0.0001
71034410|NCT00796653|141578355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.035||0.0133||95.0|0.018|0.157|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.157|0.018|0.0133
71034411|NCT00796653|141578355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.073|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.212|0.073|<0.0001
71034412|NCT00796653|141578355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.035||0.0212||95.0|0.012|0.151|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.151|0.012|0.0212
71034413|NCT00796653|141578356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.036||0.0004||95.0|0.057|0.197|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.197|0.057|0.0004
71034414|NCT00796653|141578356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.036||0.0012||95.0|0.045|0.185|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.185|0.045|0.0012
71034415|NCT00796653|141578356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.036||0.0056||95.0|0.029|0.169|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.169|0.029|0.0056
71034416|NCT00796653|141578357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.036||0.0045||95.0|0.032|0.173|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.173|0.032|0.0045
71034417|NCT00796653|141578357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.036||0.0046||95.0|0.032|0.173|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.173|0.032|0.0046
71034418|NCT00796653|141578357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.036||0.0023||95.0|0.039|0.181|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.181|0.039|0.0023
71096035|NCT00441896|141700579|SUPERIORITY|||||||0.4249|||||||ANCOVA|||||||0.4249
71096036|NCT00441896|141700579|SUPERIORITY|||||||0.4177|||||||ANCOVA|||||||0.4177
71096037|NCT00441896|141700579|SUPERIORITY|||||||0.3033|||||||ANCOVA|||||||0.3033
71096038|NCT00441896|141700579|SUPERIORITY|||||||0.3014|||||||ANCOVA|||||||0.3014
70977689|NCT01565980|141463845|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values below 0.05 are considered statistically significant in this study.|Mixed Models Analysis|||||||<0.05
71096039|NCT00441896|141700579|SUPERIORITY|||||||0.1839|||||||ANCOVA|||||||0.1839
71096040|NCT01301092|141700587|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|0.443|||||TWO_SIDED|90.0|0.395|0.497|||Mixed Linear effects model analyses|||||0.497|0.395|
70977690|NCT01565980|141463846|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values below 0.05 are considered statistically significant in this study.|Mixed Models Analysis|||||||<.05
70977691|NCT01565980|141463847|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values below 0.05 are considered statistically significant in this study.|Mixed Models Analysis|||||||<0.05
70977692|NCT01565980|141463848|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values below 0.05 are considered statistically significant in this study.|Mixed Models Analysis|||||||<0.05
70977693|NCT01565980|141463849|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values below 0.05 are considered statistically significant in this study.|Mixed Models Analysis|||||||<0.05
70977694|NCT01565980|141463850|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values above 0.05 are considered statistically insignificant in this study.|Descriptive statistics for outcomes|||||||<0.05
71096041|NCT01301092|141700588|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|2.1|||||TWO_SIDED|90.0|1.84|2.41|||Mixed Linear effects model analyses|||||2.41|1.84|
71096042|NCT01301092|141700589|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|0.962|||||TWO_SIDED|90.0|0.858|1.08|||Mixed Linear effects model analyses|||||1.08|0.858|
71096043|NCT01301092|141700590|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.05|||||TWO_SIDED|90.0|0.924|1.19|||Mixed Linear effects model analyses|||||1.19|0.924|
70977695|NCT02078219|141463885|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-29.28|||<|0.0001|TWO_SIDED|95.0|-36.99|-21.57|||ANCOVA, LOCF|||||-21.57|-36.99|<0.0001
70977696|NCT02078219|141463885|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-49.25|||<|0.0001|TWO_SIDED|95.0|-56.97|-41.52|||ANCOVA, LOCF|||||-41.52|-56.97|<0.0001
70977697|NCT02078219|141463885|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-53.33|||<|0.0001|TWO_SIDED|95.0|-61.0|-45.67|||ANCOVA, LOCF|||||-45.67|-61.00|<0.0001
70977698|NCT02761967|141463894|EQUIVALENCE|The statistical power of the study for the temporal variables was 82%. Multiple linear regression models were obtained for the first and second stages and for the total duration of delivery.||||||0.776|||||||Chi-squared|||||||0.776
70977699|NCT03136107|141463904|EQUIVALENCE|Statistical criterion defined in ISO 24444:2010 is that the 95 %CI is within ±17 % of the mean SPF||||||||||||||||CI % values (which is the percentage that half the 95 % CI represents of the mean values).|Test product CI of ±16.4% and reference product CI of ±16.6% of the mean SPF.|||
70977700|NCT02300129|141463913|SUPERIORITY_OR_OTHER|||||||0.742|TWO_SIDED|||||P value associated to treatment effect in the model. Study design with a power of 80% and a type I error at 5% (two-sided).|ANOVA|Analysis of variance including sequence, subject (sequence), period and treatment as factors in the model||||||0.7420
70977701|NCT00522392|141463942|SUPERIORITY_OR_OTHER|||||||0.092|TWO_SIDED||||||Log Rank|||Stratified log rank test was used to compare progression-free survival between the two arms.||||0.092
71096044|NCT02507284|141700592|NON_INFERIORITY|Results for the secondary safety endpoint, adverse events (AEs) in study subjects, was performed using a test for non-inferiority with a threshold of 0.50. The null hypothesis is that the treatment minus placebo proportion difference is greater than (or equal to) the margin of 0.50 and the alternative hypothesis is that the difference is less than 0.50.|Risk Ratio (RR)|0.025||||0.5|ONE_SIDED|97.5|||||t-test, 1 sided|||||||0.50
71096045|NCT01350973|141700593|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.876|TWO_SIDED|95.0|-4.2491|4.983||An ANCOVA model was employed, using the baseline triglyceride level as covariate and the treatment group as an independent variable.|ANCOVA|||||4.9830|-4.2491|0.8760
71096046|NCT01350973|141700593|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.35|||<|0.0001|TWO_SIDED|95.0|-15.9442|-6.7637||An ANCOVA model was employed, using the baseline triglyceride level as covariate and the treatment group as an independent variable.|ANCOVA|||||-6.7637|-15.9442|< 0.0001
70977702|NCT00522392|141463943|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Fisher Exact|||Fisher's exact test was used to compare the response rates between the two arms.||||0.029
70977703|NCT00522392|141463944|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED||||||Log Rank|||Stratified log-rank test was used to compare overall survival between the two arms.||||0.48
70977704|NCT03051633|141463952|SUPERIORITY|Event: Dichotimized self-reported first-time alcohol use in known participant history prior to data-collection, where substance use was not previously reported in prior measurement occasions of this four-wave longitudinal study. Episodes: Episodes represent the period of time between measurement occasions, as such, each episode represents the measured period of time between each wave of assessments. Censoring: If substance use was reported, censoring indicator indicates the risk period|Hazard Ratio (HR)|-0.42||||0.004|TWO_SIDED|95.0|-0.714|-0.126|||Regression, Logistic|Discrete time hazard model represents a survival analysis, with the outcome parameters reflecting a hazard ratio rather than odds.||Discrete time hazard represents the conditional probability that a student will experience first time alcohol use during a given measurement period, given that students did not use alchohol in a previous measurement period. Thus for each model, we tested the following hypothesis: Controlling for age at first-assessment, students attending BUYOI-assigned schools will have a lower risk of substance use uptake by the end of their eighth-grade year, relative to students attending control schools.||-0.126|-0.714|.004
71008752|NCT02055976|141525250|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.511|STANDARD_ERROR_OF_MEAN|9.682||0.398|TWO_SIDED|95.0|-21.748|16.727|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||16.727|-21.748|0.398
71096047|NCT01033071|141700611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3|||<|0.001||95.0|-7.6|-3.1||"Overall Type 1 error rate of 0.05 controlled using 'Closed Testing' principle (hypothesis of all treatment groups equal first tested at 0.05 significance level; upon rejection of this hypothesis, pairwise comparison was tested at the 0.05 level."|ANCOVA|||Analysis of covariance (ANCOVA) model with treatment group as a fixed effect and baseline value as a covariate.||-3.1|-7.6|<0.001
71096048|NCT01033071|141700611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.9|||<|0.001|TWO_SIDED|95.0|-9.2|-4.6||"Overall Type 1 error rate of 0.05 controlled using 'Closed Testing' principle (hypothesis of all treatment groups equal first tested at 0.05 significance level; upon rejection of this hypothesis, pairwise comparison was tested at the 0.05 level."|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.||-4.6|-9.2|<0.001
71096049|NCT01033071|141700614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.0|||<|0.001|TWO_SIDED|95.0|-9.4|-4.7||Tested at the 0.05 significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.||-4.7|-9.4|<0.001
70977705|NCT03051633|141463953|SUPERIORITY|Event: dichotimized self-reported first-time alcohol intoxication in known participant history prior to data collection, where intoxication was not reported in prior measurement occasions. Episodes: Represent the period of time between measurement occasions, thus, each episode represents the measured period of time between each assessment wave. Censoring: Indicates the risk period during which particpants experienced intoxication uptake.|Hazard Ratio, log|-0.39||||0.037|TWO_SIDED|95.0|-0.762|-0.018|||Regression, Logistic|Discrete time hazard model represents a survival analysis, with the outcome parameters reflecting a hazard ration rather than odds.||Discrete time hazard represents the conditional probability that a student will experience first time alcohol initiation during a given measurement period, given that students did not become intoxicated in a previous measurement period. Thus, for each model, we tested the following hypothesis: controlling for age at first assessment, students attending BUYOI-assigned schools will have a lower risk of substance use uptake at the end of their eight grade year||-0.018|-0.762|.037
70977706|NCT03051633|141463954|SUPERIORITY|Event: Dichotimized self-reported first-time marijuana use in known participant history prior to data-collection, where marijuana use was not previously reported in prior measurement occasions of this four-wave longitudinal study. Episodes: Episodes represent the period of time between measurement occasions, as such, each episode represents the measured period of time between each wave of assessments. Censoring: If marijuana use was reported, censoring indicator indicates the risk period.|Hazard Ratio, log|0.17||||0.228|TWO_SIDED|95.0|-0.104|0.444|||Regression, Logistic|Discrete time hazard model represents a survival analysis, with the outcome parameters reflecting a hazard ratio rather than odds.||Discrete time hazard represents the conditional probability that a student will experience first time marijuana use during a given measurement period, given that students did not use marijuana in a previous measurement period. Thus for each model, we tested the following hypothesis: Controlling for age at first-assessment, students attending BUYOI-assigned schools will have a lower risk of marijuana use uptake by the end of their eighth-grade year, relative to students attending control schools.||0.444|-0.104|0.228
70977707|NCT03575104|141463978|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-11.62||||0.0001|TWO_SIDED|95.0|-17.604|-5.633||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.025; statistically significant = YES||Between-treatment analysis for change from baseline in WASO (min) to Month 1 (Daridorexant 25 mg vs placebo).||-5.633|-17.604|0.0001
70977708|NCT03575104|141463978|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-2.74||||0.3669|TWO_SIDED|95.0|-8.693|3.215||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.00977; statistically significant = NO||Between-treatment analysis for change from baseline in WASO (min) to Month 1 (Daridorexant 10 mg vs placebo).||3.215|-8.693|0.3669
71034419|NCT00796653|141578358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.037||0.0077||95.0|0.026|0.169|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.169|0.026|0.0077
71034420|NCT00796653|141578358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.036||0.0009||95.0|0.05|0.193|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.193|0.050|0.0009
71096050|NCT01033071|141700614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|||<|0.001|TWO_SIDED|95.0|-11.5|-6.6||Tested at the 0.05 significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.||-6.6|-11.5|<0.001
71096051|NCT01033071|141700616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.4|||<|0.001|TWO_SIDED|95.0|-8.5|-4.3||Tested at the 0.05 significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.||-4.3|-8.5|<0.001
71096052|NCT01033071|141700616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.8|||<|0.001|TWO_SIDED|95.0|-11.0|-6.7||Tested at the 0.05 significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.||-6.7|-11.0|<0.001
71096053|NCT00004859|141700632|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED|95.0|||||Log Rank|||||||0.99
71096054|NCT01258855|141700650|OTHER|||||||0.002|||||||Log Rank|||||||0.002
71096055|NCT01258855|141700651|OTHER|||||||0.43|||||||Log Rank|||||||0.43
71096056|NCT01258855|141700654|OTHER|||||||0.003|||||||Log Rank|||||||0.003
71096057|NCT01258855|141700655|OTHER|||||||0.02|||||||Log Rank|||||||0.02
71096058|NCT01567085|141700657|OTHER|Exact binomial test|||||<|0.001||||||The p-value was calculated from an exact binomial test, where the null hypothesis was that the true failure rate = 40%.|Exact binomial test|Exact 95% confidence interval (3.6, 17.2)||Analysis of post-transplantation treatment failure rate||||< 0.001
71096059|NCT03928704|141700673|SUPERIORITY||Odds Ratio (OR)|3.51|||<|0.001|TWO_SIDED|95.0|2.0|6.16|||Regression, Logistic|||||6.16|2.00|<0.001
71096060|NCT03928704|141700674|SUPERIORITY||Odds Ratio (OR)|3.08|||<|0.001|TWO_SIDED|95.0|1.71|5.54|||Regression, Logistic|||||5.54|1.71|<0.001
70922374|NCT03547908|141335698|OTHER||Difference in Least Squares Means|30.0||||0.1853|TWO_SIDED|95.0|-14.0|74.0||P-value was from ANOVA model adjusted by the baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|ANOVA||Difference in least squares means (Diff in LSM), and its 95% CI were from ANOVA model adjusted by the baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|||74|-14|0.1853
70922375|NCT03547908|141335699|OTHER||Difference in least squares mean (LSM)|0.59||||0.2839|TWO_SIDED|95.0|-0.49|1.67|||ANOVA|The p-value was calculated using ANOVA model adjusted by the baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL).|The difference in least squares means and its 95% CI were calculated using ANOVA model adjusted by the baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL).|||1.67|-0.49|0.2839
70922376|NCT03547908|141335700|OTHER||Difference in LSM|0.13||||0.8456|TWO_SIDED|95.0|-1.2|1.46||P-value was from ANOVA model adjusted by the baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|ANOVA||Difference in LSM and its 95% CI were from ANOVA model adjusted by the baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|||1.46|-1.20|0.8456
70922377|NCT03547908|141335701|SUPERIORITY|P-value for the superiority test comparing the percentages of participants with HBV DNA \< 29 IU/mL between treatment groups was from the CMH test stratified by baseline HBeAg status (positive vs negative) and baseline HBV DNA category (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|Difference in Percentages|2.6||||0.6367|TWO_SIDED|95.0|-8.3|13.4|||Cochran-Mantel-Haenszel|||The difference in percentages of participants with HBV DNA \< 29 IU/mL between treatment groups and its 95% CI were calculated based on the MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA category (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).||13.4|-8.3|0.6367
70922378|NCT03547908|141335702|OTHER||Difference in Percentages|17.1||||0.0655|TWO_SIDED|95.0|-1.5|35.7|||Cochran-Mantel-Haenszel|P-value was calculated from CMH tests stratified by baseline HBeAg status (positive vs negative) and HBV DNA (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|The difference in percentages of participants between groups and their 95% CIs were calculated based on MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|||35.7|-1.5|0.0655
70922379|NCT03547908|141335703|OTHER||Difference in Percentages|14.1||||0.1253|TWO_SIDED|95.0|-4.3|32.6|||Cochran-Mantel-Haenszel|P-value was from the CMH tests stratified by baseline HBeAg status (positive vs negative) and baseline HBV DNA (\< 8 log10 IU/mL vs \>= 8 log10 IU/mL).|Difference in the proportion between treatment groups and its 95% CI were calculated based on the MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA (\< 8 log10 IU/mL vs \>= 8 log10 IU/mL).|||32.6|-4.3|0.1253
70922380|NCT03547908|141335704|OTHER||Difference in Percentages|7.1||||0.0591|TWO_SIDED|95.0|-0.8|15.0|||Cochran-Mantel-Haenszel|P-value was from the CMH tests stratified by baseline HBeAg status (positive vs negative)and baseline HBV DNA (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|Difference in the percentages between treatment groups and its 95% CI were calculated based on the MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|||15.0|-0.8|0.0591
70922381|NCT03547908|141335705|OTHER||Difference in Percentages|9.3||||0.0655|TWO_SIDED|95.0|-0.7|19.2||P value was from the CMH test stratified by baseline HBeAg status (positive vs negative) and baseline HBV DNA (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL). Statistically significant values are shown in bold.|Cochran-Mantel-Haenszel||Differences in percentages between treatment groups and their 95% CI were calculated based on MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|||19.2|-0.7|0.0655
70922382|NCT03358875|141335732|SUPERIORITY||Hazard Ratio (HR)|0.64|||<|0.0001|TWO_SIDED|95.0|0.527|0.778||OS in the ITT population was tested at one-sided p value boundary of 0.0120.|1-sided Log Rank Test|Stratified by stratification factors: histology (squamous vs non-squamous), line of therapy (second vs third), and PDL1 expression (≥25% vs \<25% TC).|A stratified Cox proportional hazards model with Efron's method of tie handling was used to determine hazard ratio (HR) and its 95% confidence interval (CI).|||0.778|0.527|<0.0001
70922383|NCT03358875|141335733|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.407|0.702||OS in the PD-L1 positive analysis set was tested at the one-sided p-value boundary of 0.025.|1-sided Log Rank Test|Stratified by stratification factors: histology (squamous vs non-squamous) and line of therapy (second vs third).||||0.702|0.407|<0.0001
70922384|NCT03358875|141335734|SUPERIORITY||Odds Ratio (OR)|3.86|||<|0.0001|TWO_SIDED|95.0|2.336|6.393|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) chi-square test stratified by histology, line of therapy, and PDL1 expression.||||6.393|2.336|<0.0001
70922385|NCT03358875|141335735|SUPERIORITY||Odds Ratio (OR)|8.04|||<|0.0001|TWO_SIDED|95.0|3.721|17.379|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) chi-square test stratified by histology and line of therapy.||||17.379|3.721|<0.0001
70922386|NCT03358875|141335736|SUPERIORITY||Hazard Ratio (HR)|0.31|||<|0.0001|TWO_SIDED|95.0|0.176|0.536|||Log Rank|Stratified by stratification factors: histology (squamous vs non-squamous), line of therapy (second vs third), and PDL1 expression (≥25% vs \<25% TC).|A stratified Cox proportional hazards model with Efron's method of tie handling was used to determine hazard ratio (HR) and its 95% CI.|||0.536|0.176|<0.0001
70922387|NCT03358875|141335737|SUPERIORITY||Hazard Ratio (HR)|0.16|||<|0.0001|TWO_SIDED|95.0|0.066|0.37|||Log Rank|Stratified by stratification factors: histology (squamous vs non-squamous) and line of therapy (second vs third).|A stratified Cox proportional hazards model with Efron's method of tie handling was used to determine hazard ratio (HR) and its 95% CI.|||0.370|0.066|<0.0001
70922388|NCT03358875|141335738|SUPERIORITY||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.528|0.745|||Log Rank|Stratified by stratification factors: histology (squamous vs non-squamous), line of therapy (second vs third), and PDL1 expression (≥25% vs \<25% TC).|A stratified Cox proportional hazards model with Efron's method of tie handling was used to determine hazard ratio (HR) and its 95% CI.|||0.745|0.528|<0.0001
71096061|NCT03928704|141700675|SUPERIORITY||LS Mean difference|-1.51|||<|0.001||95.0|-2.04|-0.98|||ANCOVA|||||-0.98|-2.04|<0.001
71096062|NCT03928704|141700675|SUPERIORITY||LS Mean difference|-0.91||||0.22|TWO_SIDED|95.0|-2.42|0.61|||ANCOVA|||||0.61|-2.42|0.220
71096063|NCT03928704|141700676|SUPERIORITY||Odds Ratio (OR)|3.69|||<|0.001|TWO_SIDED|95.0|2.17|6.26|||Regression, Logistic|||||6.26|2.17|<0.001
70977709|NCT03575104|141463979|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS Mean difference to placebo|-10.25||||0.0028|TWO_SIDED|95.0|-16.95|-3.548||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.01563; statistically significant = YES||Between-treatment analysis for change from baseline in WASO (min) to Month 3 (Daridorexant 25 mg vs placebo).||-3.548|-16.95|0.0028
70977710|NCT03575104|141463979|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS Mean difference to placebo|-1.95||||0.5686|TWO_SIDED|95.0|-8.666|4.764||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0; statistically significant = NO||Between-treatment analysis for change from baseline in WASO (min) to Month 3 (Daridorexant 10 mg vs placebo).||4.764|-8.666|0.5686
70922389|NCT03358875|141335739|SUPERIORITY||Hazard Ratio (HR)|0.38|||<|0.0001|TWO_SIDED|95.0|0.285|0.494|||Log Rank|Stratified by stratification factors: histology (squamous vs non-squamous) and line of therapy (second vs third).|A stratified Cox proportional hazards model with Efron's method of tie handling was used to determine hazard ratio (HR) and its 95% confidence interval (CI).|||0.494|0.285|<0.0001
70922390|NCT03358875|141335740|OTHER||Least Squares (LS) Mean Difference|5.7||||0.0008|TWO_SIDED|95.0|2.38|9.07|||Mixed Models Analysis|||The linear mixed-effect model for repeated measures (MMRM) includes baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects and visit as a repeated measure.||9.07|2.38|0.0008
70922391|NCT03358875|141335741|OTHER||LS Mean Difference|-8.3||||0.0007|TWO_SIDED|95.0|-13.02|-3.51|||Mixed Models Analysis|||Analysis of Change from Baseline in Coughing Scale. The linear mixed-effect model for repeated measures (MMRM) includes baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects and visit as a repeated measure.||-3.51|-13.02|0.0007
70922392|NCT03358875|141335741|OTHER||LS Mean Difference|-3.2||||0.0579|TWO_SIDED|95.0|-6.52|0.11|||Mixed Models Analysis|||Analysis of Change from Baseline in Dyspnoea Scale. The linear mixed-effect model for repeated measures (MMRM) includes baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects and visit as a repeated measure.||0.11|-6.52|0.0579
70922393|NCT03358875|141335741|OTHER||LS Mean Difference|-2.2||||0.2472|TWO_SIDED|95.0|-6.05|1.56|||Mixed Models Analysis|||Analysis of Change from Baseline in Chest Pain Scale. The linear mixed-effect model for repeated measures (MMRM) includes baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects and visit as a repeated measure.||1.56|-6.05|0.2472
70977711|NCT03575104|141463980|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-6.45||||0.0303|TWO_SIDED|95.0|-12.282|-0.614||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.025; statistically significant = NO||Between-treatment analysis for change from baseline in LPS (min) to Month 1 (Daridorexant 25 mg vs placebo).||-0.614|-12.282|0.0303
70977712|NCT03575104|141463980|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-2.61||||0.3782|TWO_SIDED|95.0|-8.41|3.197||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.00195; statistically significant = NO||Between-treatment analysis for change from baseline in LPS (min) to Month 1 (Daridorexant 10 mg vs placebo).||3.197|-8.41|0.3782
71034421|NCT00796653|141578358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|STANDARD_ERROR_OF_MEAN|0.037||0.0339||95.0|0.006|0.149|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.149|0.006|0.0339
71034422|NCT00796653|141578359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.066|STANDARD_ERROR_OF_MEAN|0.037||0.0718||95.0|-0.006|0.139|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.139|-0.006|0.0718
71034423|NCT00796653|141578359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.037||0.0863||95.0|-0.009|0.135|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.135|-0.009|0.0863
71034424|NCT00796653|141578359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038|STANDARD_ERROR_OF_MEAN|0.037||0.2982||95.0|-0.034|0.111|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.111|-0.034|0.2982
71096064|NCT03928704|141700677|SUPERIORITY||Odds Ratio (OR)|4.52|||<|0.001|TWO_SIDED|95.0|2.06|9.93|||Regression, Logistic|||||9.93|2.06|<0.001
71096065|NCT03928704|141700678|SUPERIORITY||Odds Ratio (OR)|5.43|||<|0.001|TWO_SIDED|95.0|2.41|12.23|||Regression, Logistic|||||12.23|2.41|<0.001
70977713|NCT03575104|141463981|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-9.01||||0.0053|TWO_SIDED|95.0|-15.339|-2.684||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.00313; statistically significant = NO||Between-treatment analysis for change from baseline in LPS (min) to Month 3 (Daridorexant 25 mg vs placebo).||-2.684|-15.339|0.0053
70977714|NCT03575104|141463981|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-3.19||||0.3233|TWO_SIDED|95.0|-9.528|3.146||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0; statistically significant = NO||Between-treatment analysis for change from baseline in LPS (min) to Month 3 (Daridorexant 10 mg vs placebo).||3.146|-9.528|0.3233
70977715|NCT03575104|141463982|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|16.13|||<|0.0001|TWO_SIDED|95.0|8.224|24.035||Hypothesis testing result: threshold for significance p = 0.0125; statistically significant = YES|Mixed Models Analysis|||Between-treatment analysis for change from baseline in sTST (min) to Month 1 (Daridorexant 25 mg vs placebo).||24.035|8.224|<.0001
70977716|NCT03575104|141463982|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|13.37|||=|0.0009|TWO_SIDED|95.0|5.507|21.226||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0; statistically significant = NO||Between-treatment analysis for change from baseline in sTST (min) to Month 1 (Daridorexant 10 mg vs placebo).||21.226|5.507|= 0.0009
70977717|NCT03575104|141463983|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|19.06|||<|0.0001|TWO_SIDED|95.0|10.125|27.994||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.00781; statistically significant = YES||Between-treatment analysis for change from baseline in sTST (min) to Month 3 (Daridorexant 25 mg vs placebo).||27.994|10.125|<.0001
71034425|NCT00796653|141578360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.037||0.019||95.0|0.014|0.16|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.160|0.014|0.0190
71096066|NCT03928704|141700679|SUPERIORITY||Odds Ratio (OR)|3.31|||<|0.001|TWO_SIDED|95.0|1.87|5.84|||Regression, Logistic|||||5.84|1.87|<0.001
71034426|NCT00796653|141578360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.037||0.0601||95.0|-0.003|0.143|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.143|-0.003|0.0601
71096067|NCT03928704|141700680|SUPERIORITY||LS Mean difference|-1.48|||<|0.001||95.0|-1.99|-0.97|||ANCOVA|||||-0.97|-1.99|<0.001
71096068|NCT03928704|141700680|SUPERIORITY||LS Mean difference|-1.25||||0.019|TWO_SIDED|95.0|-2.26|-0.24|||ANCOVA|||||-0.24|-2.26|0.019
71096069|NCT03928704|141700681|SUPERIORITY||LS Mean difference|-1.8|||<|0.001||95.0|-2.42|-1.18|||ANCOVA|||||-1.18|-2.42|<0.001
71096070|NCT03928704|141700681|SUPERIORITY||LS Mean difference|-1.09||||0.199|TWO_SIDED|95.0|-2.83|0.65|||ANCOVA|||||0.65|-2.83|0.199
71096071|NCT03928704|141700682|SUPERIORITY||LS Mean difference|-2.63|||<|0.001||95.0|-3.66|-1.61|||ANCOVA|||||-1.61|-3.66|<0.001
71096072|NCT03928704|141700682|SUPERIORITY||LS Mean difference|-1.84||||0.17|TWO_SIDED|95.0|-4.56|0.89|||ANCOVA|||||0.89|-4.56|0.170
71096073|NCT03928704|141700683|SUPERIORITY||LS Mean difference|3.96|||<|0.001|TWO_SIDED|95.0|2.08|5.83|||ANCOVA|||||5.83|2.08|<0.001
71096074|NCT03928704|141700683|SUPERIORITY||LS Mean difference|7.27||||0.035|TWO_SIDED|95.0|0.6|13.95|||ANCOVA|||||13.95|0.60|0.035
71096075|NCT03928704|141700684|SUPERIORITY||LS Mean difference|-0.33|||<|0.001|TWO_SIDED|95.0|-0.52|-0.14|||ANCOVA|||||-0.14|-0.52|<0.001
70977718|NCT03575104|141463983|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|13.58|||=|0.0028|TWO_SIDED|95.0|4.691|22.475||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0; statistically significant = NO||Between-treatment analysis for change from baseline in sTST (min) to Month 3 (Daridorexant 10 mg vs placebo).||22.475|4.691|= 0.0028
70977719|NCT03575104|141463984|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-0.75|||=|0.0733|TWO_SIDED|95.0|-1.581|0.071||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.00625; statistically significant = NO||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 1 (Daridorexant 25 mg vs placebo).||0.071|-1.581|= 0.0733
70977720|NCT03575104|141463984|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-0.43|||=|0.3048|TWO_SIDED|95.0|-1.251|0.392||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0; statistically significant = NO||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 1 (Daridorexant 10 mg vs placebo).||0.392|-1.251|= 0.3048
70977721|NCT03575104|141463985|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-1.25|||=|0.012|TWO_SIDED|95.0|-2.23|-0.276||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.00391; statistically significant = NO||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 3 (Daridorexant 25 mg vs placebo).||-0.276|-2.230|= 0.0120
71034427|NCT00796653|141578360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.037||0.2573||95.0|-0.031|0.115|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.115|-0.031|0.2573
71034428|NCT00796653|141578361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.037||0.02||95.0|0.014|0.16|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.160|0.014|0.0200
71034429|NCT00796653|141578361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.037||0.0013||95.0|0.047|0.194|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.194|0.047|0.0013
71034430|NCT00796653|141578361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.037||0.1598||95.0|-0.021|0.126|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.126|-0.021|0.1598
71034431|NCT00796653|141578362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.038||0.0307||95.0|0.008|0.155|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.155|0.008|0.0307
71034432|NCT00796653|141578362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.038||0.0073||95.0|0.027|0.175|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.175|0.027|0.0073
71034433|NCT00796653|141578362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038|STANDARD_ERROR_OF_MEAN|0.038||0.3147||95.0|-0.036|0.112|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.112|-0.036|0.3147
71034434|NCT00796653|141578363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.233|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.16|0.306|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.306|0.160|<0.0001
71096076|NCT03928704|141700684|SUPERIORITY||LS Mean difference|-0.5||||0.086|TWO_SIDED|95.0|-1.07|0.07|||ANCOVA|||||0.07|-1.07|0.086
71096077|NCT03928704|141700685|SUPERIORITY||LS Mean difference|-1.06|||=|0.013|TWO_SIDED|95.0|-1.88|-0.23|||ANCOVA|||||-0.23|-1.88|=0.013
70977722|NCT03575104|141463985|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-0.73|||=|0.1393|TWO_SIDED|95.0|-1.706|0.239||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0; statistically significant = NO||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 3 (Daridorexant 10 mg vs placebo).||0.239|-1.706|= 0.1393
71096078|NCT03928704|141700686|SUPERIORITY||Odds Ratio (OR)|3.49|||<|0.001|TWO_SIDED|95.0|1.84|6.62|||Regression, Logistic|||||6.62|1.84|<0.001
70977723|NCT03575104|141463986|OTHER||LS mean difference to placebo|0.93||||0.2506|TWO_SIDED|95.0|0.82|1.05||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 1 (Daridorexant 10 mg vs placebo).||1.05|0.82|0.2506
70977724|NCT03575104|141463986|OTHER||LS mean difference to placebo|0.8||||0.0004|TWO_SIDED|95.0|0.71|0.91||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 1 (Daridorexant 25 mg vs placebo).||0.91|0.71|0.0004
70977725|NCT03575104|141463987|OTHER||LS mean difference to placebo|0.96||||0.5037|TWO_SIDED|95.0|0.84|1.09||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 3 (Daridorexant 10 mg vs placebo).||1.09|0.84|0.5037
70977726|NCT03575104|141463987|OTHER||LS mean difference to placebo|0.81||||0.0021|TWO_SIDED|95.0|0.71|0.93||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in LPS (min) to Month 3 (Daridorexant 25 mg vs placebo).||0.93|0.71|0.0021
70977727|NCT00432237|141463993|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
70977728|NCT00432237|141463993|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
70977729|NCT00432237|141463994|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
70977730|NCT00432237|141463994|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
70977731|NCT00432237|141463995|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
70977732|NCT00432237|141463995|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
70977733|NCT00432237|141463996|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
71034435|NCT00796653|141578363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.229|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.156|0.302|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.302|0.156|<0.0001
71034436|NCT00796653|141578363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.248|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.175|0.321|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.321|0.175|<0.0001
71034437|NCT00796653|141578364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.247|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.174|0.321|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.321|0.174|<0.0001
71034438|NCT00796653|141578364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.221|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.148|0.295|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.295|0.148|<0.0001
71034439|NCT00796653|141578364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.254|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.18|0.328|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.328|0.180|<0.0001
71096079|NCT03083379|141700698|EQUIVALENCE|Equivalency is defined as no statistically significant difference in dorsal region redistribution of ventilation following breath cycle 1, 2, and 3 lung expansion therapy sequences.||||||0.9|||||||Mann-Whitney U test|||||||.90
71096080|NCT03403517|141700705|SUPERIORITY||Risk Ratio (RR)|0.859||||0.213|TWO_SIDED|95.0|0.682|1.082|||Fisher Exact|||||1.082|0.682|0.213
70977734|NCT00432237|141463996|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
70977735|NCT00432237|141463997|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
70977736|NCT00432237|141463997|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
70977737|NCT00432237|141463998|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
70977738|NCT00432237|141463998|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
70977739|NCT00432237|141463999|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
70977740|NCT00432237|141463999|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
70977741|NCT00432237|141464000|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
70977742|NCT00432237|141464000|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
71096081|NCT03403517|141700709|SUPERIORITY||Risk Ratio (RR)|0.977|||>|0.999|TWO_SIDED|95.0|0.557|1.715|||Fisher Exact|||||1.715|0.557|>0.999
70977743|NCT00603239|141464001|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No adjustments were made (alpha = 0.05).|ANCOVA|No adjustments for multiplicity were made.||Null hypothesis = Change from baseline in HbA1c is equal between the two treatment groups. Greater than 99% power to detect a difference between treatment groups of 0.88% in change in HbA1c from baseline using a 2-sided t-test at a significance level of 0.05.||||<0.001
70977744|NCT00603239|141464002|SUPERIORITY_OR_OTHER|||||||0.113||95.0||||No adjustments (alpha = 0.05).|CMH test|No adjustment for multiplicity.||Null hypothesis = Proportion of subjects with HbA1c \<= 7% is equal between the two treatment groups.||||0.113
70977745|NCT00603239|141464003|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||No adjustments (alpha = 0.05).|CMH test|No adjustment for multiplicity.||Null hypothesis = Proportion of subjects achieving HbA1c \<= 6.5% is equal between the two treatment groups.||||0.004
70977746|NCT00603239|141464004|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||No adjustments (alpha = 0.05).|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change from baseline in FSG is equal between the two treatment groups.||||0.009
70977747|NCT00603239|141464005|SUPERIORITY_OR_OTHER|||||||0.176||95.0||||No adjustments (alpha = 0.05).|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change from baseline to endpoint in body weight is equal between the two treatment groups.||||0.176
70977748|NCT00603239|141464007|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||No adjustments (alpha = 0.05).|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change form baseline in HOMA-B is equal between the two treatment groups.||||0.009
70977749|NCT00603239|141464008|SUPERIORITY_OR_OTHER|||||||0.794||95.0||||No adjustments (alpha = 0.05).|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change from baseline in HOMA-S is equal between the two treatment groups.||||0.794
71096082|NCT03403517|141700710|SUPERIORITY|||||||0.16|||||||Fisher Exact|||||||0.160
70977750|NCT00603239|141464009|SUPERIORITY_OR_OTHER|||||||1||95.0||||No adjustments (alpha = 0.05).|Fisher Exact|No adjustment for multiplicity.||Null hypothesis = Incidence of minor hypoglycemia episodes is equal between the two treatment groups.||||1.00
70977751|NCT00603239|141464010|SUPERIORITY_OR_OTHER|||||||0.342||95.0||||No adjustments (alpha = 0.05).|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change from baseline in IWQOL-Lite Total Score is equal between the two treatment groups. This statistical analysis is for the Total Score only.||||0.342
70977752|NCT00603239|141464011|SUPERIORITY_OR_OTHER|||||||0.186||95.0||||No adjustments (alpha = 0.05)|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change from baseline in EQ-5D score is equal between the two treatment groups. This statistical analysis is for the EQ-5D Health State Score only.||||0.186
70977753|NCT01354132|141464012|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.50
70977754|NCT01354132|141464013|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||||||0.39
70977755|NCT01354132|141464014|SUPERIORITY|||||||0.52|||||||t-test, 2 sided|||||||0.52
70977756|NCT01354132|141464015|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||||||0.71
70977757|NCT01354132|141464016|SUPERIORITY|||||||0.022|||||||t-test, 2 sided|||Speed of Processing||||0.022
70977758|NCT01354132|141464017|SUPERIORITY|||||||0.27|||||||t-test, 2 sided|||||||0.270
70977759|NCT01354132|141464018|SUPERIORITY|||||||0.153|||||||t-test, 2 sided|||||||0.153
70977760|NCT01354132|141464019|SUPERIORITY|||||||0.876|||||||t-test, 2 sided|||||||0.876
70977761|NCT01354132|141464020|SUPERIORITY|||||||0.464|||||||t-test, 2 sided|||||||0.464
70977762|NCT01354132|141464021|SUPERIORITY|||||||0.741|||||||t-test, 2 sided|||||||0.741
70977763|NCT01354132|141464022|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
70977764|NCT01354132|141464023|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||||||0.33
70977765|NCT01354132|141464024|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||||||0.90
71096083|NCT03695094|141700726|OTHER||Geometric mean ratio|0.725|||||TWO_SIDED|90.0|0.586|0.896|||ANOVA|||The analysis of variance model (ANOVA) included the fixed effects of treatment group. The natural logs were taken of the dependent variables and were back-transformed after the analysis. The geometric mean ratio and the respective 90% confidence interval (CI) was derived for the Inducers group vs the Neutral-control group from the ANOVA model using least-squares means difference.||0.896|0.586|
71096084|NCT03695094|141700728|OTHER||Geometric mean ratio|0.636|||||TWO_SIDED|90.0|0.504|0.801|||ANOVA|||The analysis of variance model (ANOVA) included the fixed effects of treatment group. The natural logs were taken of the dependent variables and were back-transformed after the analysis. The geometric mean ratio and the respective 90% confidence interval (CI) was derived for the Inducers group vs the Neutral-control group from the ANOVA model using least-squares means difference.||0.801|0.504|
70977766|NCT01354132|141464025|SUPERIORITY|||||||0.6732|||||||t-test, 1 sided|||||||0.6732
70977767|NCT01354132|141464026|SUPERIORITY|||||||0.8786|||||||t-test, 2 sided|||||||0.8786
70977768|NCT01354132|141464027|SUPERIORITY|||||||0.5622|||||||t-test, 2 sided|||||||0.5622
70977769|NCT01354132|141464028|SUPERIORITY|||||||0.9574|||||||t-test, 2 sided|||||||0.9574
70977770|NCT01354132|141464029|SUPERIORITY|||||||0.0043|||||||t-test, 2 sided|||||||0.0043
70977771|NCT01354132|141464030|SUPERIORITY|||||||0.3804|||||||t-test, 2 sided|||||||0.3804
70977772|NCT01354132|141464031|SUPERIORITY|||||||0.9403|||||||t-test, 2 sided|||||||0.9403
70977773|NCT01354132|141464032|SUPERIORITY|||||||0.9215|||||||t-test, 2 sided|||||||0.9215
70977774|NCT04355013|141464038|OTHER|Agreement between different methods of temperature measurement (Bland-Altman plot with multiple measurements per individual).|Bland-Altman for repeated measures|-0.16|STANDARD_DEVIATION|0.47|||TWO_SIDED|95.0|-1.1|0.77||||||Arterial outlet-nasopharyngeal temperatures||0.77|-1.10|
70977775|NCT04355013|141464038|OTHER|Agreement between different methods of temperature measurement (Bland-Altman plot with multiple measurements per individual).|Mean Difference (Final Values)|0.16|STANDARD_DEVIATION|0.4|||TWO_SIDED|95.0|-0.63|0.95|||Bland-Altman|||Arterial-venous inflow temperatures||0.95|-0.63|
70977776|NCT04355013|141464038|OTHER|Agreement between different methods of temperature measurement (Bland-Altman plot with multiple measurements per individual).|Mean Difference (Final Values)|-0.62|STANDARD_DEVIATION|0.69|||TWO_SIDED|95.0|-1.98|0.74|||Bland-Altman|||Arterial outlet-bladder||0.74|-1.98|
70977777|NCT04355013|141464038|OTHER|Agreement between different methods of temperature measurement (Bland-Altman plot with multiple measurements per individual).|Mean Difference (Final Values)|0.08|STANDARD_DEVIATION|0.74|||TWO_SIDED|95.0|-1.38|1.54|||Bland-Altman|||Arterial outlet- Tcore||1.54|-1.38|
70977778|NCT04355013|141464038|OTHER|Agreement between different methods of temperature measurement (Bland-Altman plot with multiple measurements per individual).|Mean Difference (Final Values)|0.32|STANDARD_DEVIATION|0.53|||TWO_SIDED|95.0|-0.73|1.38||||||Nasopharyngeal-venous inflow temperatures||1.38|-0.73|
71034440|NCT00796653|141578365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.141|0.289|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.289|0.141|<0.0001
71034441|NCT00796653|141578365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.151|0.3|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.300|0.151|<0.0001
71034442|NCT00796653|141578365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.191|0.34|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.340|0.191|<0.0001
70977779|NCT04355013|141464038|OTHER|Agreement between different methods of temperature measurement (Bland-Altman plot with multiple measurements per individual).|Mean Difference (Final Values)|-0.46|STANDARD_DEVIATION|0.52|||TWO_SIDED|95.0|-1.5|0.59||||||Nasopharyngeal-bladder temperatures||0.59|-1.50|
70977780|NCT04355013|141464038|OTHER|Bland-Altman for repeated measures|Bland-Altman for repeated measures|0.24|STANDARD_DEVIATION|0.58|||TWO_SIDED|95.0|-0.9|1.39||||||Nasopharyngeal-Tcore temperatures||1.39|-0.90|
70977781|NCT00862251|141464039|SUPERIORITY_OR_OTHER_LEGACY||Percent change in least-square means|-14.76|||<|0.001|TWO_SIDED|95.0|-19.61|-9.91|||Longitudinal data analysis (LDA)|||||-9.91|-19.61|<0.001
70977782|NCT00862251|141464040|SUPERIORITY_OR_OTHER_LEGACY||Percent change in Least Square Means|-13.62|||<|0.001|TWO_SIDED|95.0|-20.44|-6.79|||Longitudinal data analysis (LDA)|||||-6.79|-20.44|<0.001
70977783|NCT00862251|141464041|SUPERIORITY_OR_OTHER_LEGACY||Percent change in least squares mean|-15.73|||<|0.001|TWO_SIDED|95.0|-22.65|-8.81|||Longitudinal Data Analysis (LDA)|||||-8.81|-22.65|<0.001
70977784|NCT00862251|141464042|SUPERIORITY_OR_OTHER_LEGACY||Percent Change in Least Squares Means|-3.81||||0.06|TWO_SIDED|95.0|-7.78|0.17|||Longitudinal Data Analysis|||||0.17|-7.78|0.060
70977785|NCT00862251|141464043|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.9|||<|0.001|TWO_SIDED|95.0|2.5|6.2|||Regression, Logistic|||||6.2|2.5|<0.001
70977786|NCT00862251|141464043|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9|||<|0.001|TWO_SIDED|95.0|1.3|2.6|||Regression, Logistic|||||2.6|1.3|<0.001
70977787|NCT00862251|141464044|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.5|||<|0.001|TWO_SIDED|95.0|2.3|8.5|||Regression, Logistic|||||8.5|2.3|<0.001
70977788|NCT00862251|141464045|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.5|||<|0.001|TWO_SIDED|95.0|1.9|6.6|||Regression, Logistic|||||6.6|1.9|<0.001
70977789|NCT00862251|141464046|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-8.33|||<|0.001|TWO_SIDED|95.0|-11.38|-5.28|||Longitudinal data analysis (LDA)|||||-5.28|-11.38|<0.001
70977790|NCT00862251|141464046|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.63||||0.039|TWO_SIDED|95.0|-5.13|-0.13|||Longitudinal data analysis (LDA)|||||-0.13|-5.13|0.039
70977791|NCT00862251|141464047|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.88||||0.316|TWO_SIDED|95.0|-8.53|2.77|||Longitudinal data analysis (LDA)|||||2.77|-8.53|0.316
70977792|NCT00862251|141464047|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.16||||0.356|TWO_SIDED|95.0|-6.75|2.43|||Longitudinal data analysis (LDA)|||||2.43|-6.75|0.356
70977793|NCT00862251|141464048|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.47||||0.756|TWO_SIDED|95.0|-2.5|3.45|||Longitudinal data analysis (LDA)|||||3.45|-2.50|0.756
70977794|NCT00862251|141464048|SUPERIORITY_OR_OTHER_LEGACY||Least Sqares Mean Difference|-0.52||||0.675|TWO_SIDED|95.0|-2.96|1.92|||Longitudinal data analysis (LDA)|||||1.92|-2.96|0.675
70977795|NCT00862251|141464049|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-11.62|||<|0.001|TWO_SIDED|95.0|-15.93|-7.31|||Longitudinal data analysis (LDA)|||||-7.31|-15.93|<0.001
70977796|NCT00862251|141464049|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-3.18||||0.078|TWO_SIDED|95.0|-6.71|0.35|||Longitudinal data analysis (LDA)|||||0.35|-6.71|0.078
71096085|NCT01779362|141700803|SUPERIORITY||||||>|0.05||||||All analyses were conducted with values on a log scale and re-exponentiated for presentation.|Regression, Linear|Measures of ß-cell response were modeled simultaneously with insulin sensitivity (M/I) using 2-df seemingly unrelated regression models.||Seemingly unrelated regression was used to compare treatment arms on the combination of insulin sensitivity (M/I as calculated from the hyperglycemic clamp) and insulin secretion (steady-state C-peptide and ACPRmax as co-primary; ACPRg as major secondary,). See statistical analysis plan for further details and R code.||||>0.05
70977797|NCT00862251|141464050|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-14.16|||<|0.001|TWO_SIDED|95.0|-20.23|-8.1|||Longitudinal data analysis (LDA)|||||-8.10|-20.23|<0.001
70977798|NCT00862251|141464050|SUPERIORITY_OR_OTHER_LEGACY||Least Sqares Mean Difference|-2.56||||0.313|TWO_SIDED|95.0|-7.53|2.41|||Longitudinal data analysis (LDA)|||||2.41|-7.53|0.313
70977799|NCT00862251|141464051|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-8.17|||<|0.001|TWO_SIDED|95.0|-12.1|-4.23|||Longitudinal data analysis (LDA)|||||-4.23|-12.10|<0.001
70977800|NCT00862251|141464051|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-1.83||||0.266|TWO_SIDED|95.0|-5.05|1.4|||Longitudinal data analysis (LDA)|||||1.40|-5.05|0.266
70977801|NCT00862251|141464052|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-11.45|||<|0.001|TWO_SIDED|95.0|-17.16|-5.75|||Longitudinal data analysis (LDA)|||||-5.75|-17.16|<0.001
70977802|NCT00862251|141464052|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.13||||0.371|TWO_SIDED|95.0|-6.81|2.54|||Longitudinal data analysis (LDA)|||||2.54|-6.81|0.371
70977803|NCT00862251|141464053|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-8.01|||<|0.001|TWO_SIDED|95.0|-11.46|-4.56|||Longitudinal data analysis (LDA)|||||-4.56|-11.46|<0.001
70977804|NCT00862251|141464053|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.95||||0.041|TWO_SIDED|95.0|-5.78|-0.12|||Longitudinal data analysis (LDA)|||||-0.12|-5.78|0.041
70977805|NCT00862251|141464054|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.57||||0.218|TWO_SIDED|95.0|-0.93|4.06|||Longitudinal data analysis (LDA)|||||4.06|-0.93|0.218
70977806|NCT00862251|141464054|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.22||||0.832|TWO_SIDED|95.0|-2.27|1.83|||Longitudinal data analysis (LDA)|||||1.83|-2.27|0.832
70977807|NCT00862251|141464055|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-8.91|||<|0.001|TWO_SIDED|95.0|-13.36|-4.47|||Longitudinal data analysis (LDA)|||||-4.47|-13.36|<0.001
71034443|NCT00796653|141578366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.106|0.258|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.258|0.106|<0.0001
71034444|NCT00796653|141578366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.105|0.256|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.256|0.105|<0.0001
71034445|NCT00796653|141578366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.132|0.283|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.283|0.132|<0.0001
71034446|NCT00796653|141578367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.111|0.265|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.265|0.111|<0.0001
71096086|NCT01779362|141700804|SUPERIORITY||||||>|0.05|||||||Regression, Linear|||||||>0.05
71096087|NCT01779362|141700805|SUPERIORITY||||||>|0.05|||||||Regression, Linear|||||||>0.05
70977808|NCT00862251|141464055|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.52||||0.175|TWO_SIDED|95.0|-6.17|1.13|||Longitudinal data analysis (LDA)|||||1.13|-6.17|0.175
70977809|NCT00862251|141464056|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.78||||0.749|TWO_SIDED|95.0|-19.88|14.32|||Longitudinal data analysis (LDA)|||||14.32|-19.88|0.749
70977810|NCT00862251|141464056|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|4.69||||0.494|TWO_SIDED|95.0|-8.73|18.1|||Longitudinal data analysis (LDA)|||||18.10|-8.73|0.494
70977811|NCT01147926|141464073|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70977812|NCT03417440|141464092|SUPERIORITY||Estimated mean change|-898.0||||0.37|TWO_SIDED|95.0|-2884.82|1088.82||A single model was run including variables indicating Proof Positive (yes/no), Coach Me (yes/no), and On Your Feet (yes/no) and their interaction terms.|Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||1088.82|-2884.82|.37
70977813|NCT03417440|141464092|SUPERIORITY||Estimated mean change|-2602.1||||0.02|TWO_SIDED|95.0|-4687.44|-516.69||A single model was run including variables indicating Proof Positive (yes/no), Coach Me (yes/no), and On Your Feet (yes/no) and their interaction terms.|Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||-516.69|-4687.44|.02
70977814|NCT03417440|141464092|SUPERIORITY||Estimated mean change|-1244.9||||0.23|TWO_SIDED|95.0|-3287.6|797.85|||Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||797.85|-3287.60|.23
70977815|NCT03417440|141464092|SUPERIORITY||Estimated mean change|1468.5||||0.31|TWO_SIDED|95.0|-1368.93|4306.02|||Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||4306.02|-1368.93|0.31
70977816|NCT03417440|141464092|SUPERIORITY||Estimated mean change|388.1||||0.78|TWO_SIDED|95.0|-2397.51|3173.62|||Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||3173.62|-2397.51|0.78
71096088|NCT01779362|141700806|SUPERIORITY||||||<|0.001||||||For all 3 secondary outcomes at M12, p\<0.001, with the Liraglutide+Metformin group different from the 3 others (all p\<0.001).|ANOVA|||Analyses were completed on a log scale and re-exponentiated for display.||||<0.001
70977817|NCT03417440|141464092|SUPERIORITY||Estimated mean change|1991.2||||0.17|TWO_SIDED|95.0|-865.52|4847.86|||Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||4847.86|-865.52|0.17
70977818|NCT03417440|141464092|SUPERIORITY||Estimated mean change|-590.7||||0.77|TWO_SIDED|95.0|-4591.17|3409.75|||Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||3409.75|-4591.17|0.77
70977819|NCT03417440|141464093|SUPERIORITY||Mean Difference (Net)|-23.0|STANDARD_DEVIATION|118.7||0.17|ONE_SIDED|90.0||8.3||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided|||||8.3||0.17
70977820|NCT03417440|141464093|SUPERIORITY||Mean Difference (Net)|37.7|STANDARD_DEVIATION|117.8||0.94|ONE_SIDED|90.0||68.8||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided|||||68.8||0.94
70977821|NCT03417440|141464093|SUPERIORITY||Mean Difference (Net)|52.0|STANDARD_DEVIATION|116.4||0.99|ONE_SIDED|90.0||82.7||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided|||||82.7||0.99
70977822|NCT03417440|141464094|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_DEVIATION|51.0||0.47|ONE_SIDED|90.0|-12.5|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-12.5|0.47
70977823|NCT03417440|141464094|SUPERIORITY||Mean Difference (Net)|5.0|STANDARD_DEVIATION|51.0||0.315|ONE_SIDED|90.0|-8.3|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-8.3|0.315
70977824|NCT03417440|141464094|SUPERIORITY||Mean Difference (Net)|3.9|STANDARD_DEVIATION|51.0||0.355|ONE_SIDED|90.0|-9.4|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-9.4|0.355
70977825|NCT03417440|141464095|SUPERIORITY||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|1.0||0.86|ONE_SIDED|90.0|-1.3|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.3|0.86
70977826|NCT03417440|141464095|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.0||0.38|ONE_SIDED|90.0|-0.6|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.6|0.38
70977827|NCT03417440|141464095|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|1.0||0.66|ONE_SIDED|90.0|-1.1|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.1|0.66
70977828|NCT03417440|141464096|SUPERIORITY||Mean Difference (Net)|-1.9|STANDARD_DEVIATION|19.2||0.69|ONE_SIDED|90.0|-6.9|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-6.9|0.69
70977829|NCT03417440|141464096|SUPERIORITY||Mean Difference (Net)|-1.0|STANDARD_DEVIATION|19.2||0.6|ONE_SIDED|90.0|-6.0|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-6.0|0.60
70977830|NCT03417440|141464096|SUPERIORITY||Mean Difference (Net)|4.8|STANDARD_DEVIATION|19.0||0.11|ONE_SIDED|90.0|-0.2|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.2|0.11
70977831|NCT03417440|141464097|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|1.0||0.94|ONE_SIDED|90.0|-0.7|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.7|0.94
71096089|NCT01795937|141700809|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|198.55|STANDARD_DEVIATION|14.2|||TWO_SIDED|90.0|182.43|216.09|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison faldaprevir+itraconazole : faldaprevir||216.09|182.43|
70977832|NCT03417440|141464097|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_DEVIATION|1.1||0.73|ONE_SIDED|90.0|-0.4|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.4|0.73
71034447|NCT00796653|141578367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.214|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.138|0.291|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.291|0.138|<0.0001
71034448|NCT00796653|141578367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.115|0.269|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.269|0.115|<0.0001
71034449|NCT00796653|141578368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.707|STANDARD_ERROR_OF_MEAN|4.435||0.0021|TWO_SIDED|95.0|5.004|22.411|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||22.411|5.004|0.0021
70922394|NCT03599648|141335744|SUPERIORITY|||||||0.361||||||baseline versus immediately after 16-week BPT-E intervention|t-test, 2 sided|||||||.361
70922395|NCT03599648|141335744|SUPERIORITY|||||||0.126||||||baseline versus 6 months after BPT-E intervention|t-test, 2 sided|||||||.126
70922396|NCT03599648|141335744|SUPERIORITY|||||||0||||||baseline versus 12 months after BPT-E intervention|t-test, 2 sided|||||||.000
70922397|NCT03599648|141335744|SUPERIORITY|||||||0||||||baseline versus immediately after 16 week BPT-M intervention|t-test, 2 sided|||||||.000
70922398|NCT03599648|141335744|SUPERIORITY|||||||0||||||baseline versus 6 months after BPT-M intervention|t-test, 2 sided|||||||.000
70922399|NCT03599648|141335744|SUPERIORITY|||||||0||||||baseline versus 12 months after BPT-M intervention|t-test, 2 sided|||||||.000
70922400|NCT03599648|141335745|SUPERIORITY|||||||0.035||||||Baseline versus immediately following 16-week BPT-E intervention|t-test, 2 sided|||||||.035
70922401|NCT03599648|141335745|SUPERIORITY|||||||0.001||||||Baseline versus 6-months after BPT-E intervention|t-test, 2 sided|||||||.001
70922402|NCT03599648|141335745|SUPERIORITY|||||||0||||||Baseline versus 12 months after BPT-E intervention|t-test, 2 sided|||||||.000
70922403|NCT03599648|141335745|SUPERIORITY|||||||0||||||Baseline versus immediately after 16-week BPT-M intervention|t-test, 2 sided|||||||.000
70922404|NCT03599648|141335745|SUPERIORITY|||||||0||||||Baseline versus 6 months after BPT-M intervention|t-test, 2 sided|||||||.000
70922405|NCT03599648|141335745|SUPERIORITY|||||||0||||||Baseline versus 12 months after BPT-M intervention|t-test, 2 sided|||||||.000
70922406|NCT03599648|141335746|SUPERIORITY|||||||0||||||Baseline versus immediately after 16-week BPT-E intervention|t-test, 2 sided|||||||.000
70922407|NCT03599648|141335746|SUPERIORITY|||||||0||||||Baseline versus 6 months after BPT-E intervention|t-test, 2 sided|||||||.000
70922408|NCT03599648|141335746|SUPERIORITY|||||||0||||||Baseline versus 12 months after BPT-E intervention|t-test, 2 sided|||||||.000
70922409|NCT03599648|141335746|SUPERIORITY|||||||0||||||Baseline versus immediately after 16-week BPT-M intervention|t-test, 2 sided|||||||.000
70922410|NCT03599648|141335746|SUPERIORITY|||||||0||||||Baseline versus 6 months after BPT-M intervention|t-test, 2 sided|||||||.000
70922411|NCT03599648|141335746|SUPERIORITY|||||||0||||||baseline versus 12 months after BPT-M intervention|t-test, 2 sided|||||||.000
70922412|NCT02380612|141335748|OTHER||Geometric Mean Ratio|1.4575|||||TWO_SIDED|||||||||||||
70922413|NCT03494504|141335787|SUPERIORITY||Odds Ratio (OR)|2.36|||||TWO_SIDED|95.0|1.46|3.84||||||||3.84|1.46|
70922414|NCT03494504|141335787|SUPERIORITY||Odds Ratio (OR)|1.81|||||TWO_SIDED|95.0|1.11|2.94||||||||2.94|1.11|
70922415|NCT01631214|141335800|SUPERIORITY|The primary endpoints were tested at the 5% level (2-sided), accounting for multiplicity using the Hochberg procedure. If the larger of the 2 p-values was significant at the 0.05 level (2-sided), the statistical testing continued to the secondary endpoint in the testing sequence.|Odds Ratio (OR)|0.48|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|0.36|0.64|||Regression, Logistic|Based on a logistic regression model adjusted for age strata, baseline total hip BMD T-score and presence of severe vertebral fracture at baseline.|Values \< 1 for odds ratio favor romosozumab. The standard error (SE) represents the standard error of log(odds ratio).|||0.64|0.36|<0.001
70922416|NCT01631214|141335800|SUPERIORITY||Risk Ratio (RR)|0.5|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.38|0.66|||||SE represents the standard error of log (risk ratio).|"The risk ratio (ratio of percentages, Romosozumab:Alendronate) was based on the Mantel Haenszel method, adjusted for age strata (\<75 vs. ≥75 years), the presence or absence of severe vertebral fracture at baseline, and baseline bone mineral density T-score at the total hip (≤ -2.5, \> -2.5).~Values \< 1 for risk ratio favor romosozumab."||0.66|0.38|
70922417|NCT01631214|141335800|SUPERIORITY||Absolute risk reduction|4.03|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|95.0|2.5|5.57||||||"The absolute risk reduction (difference in percentages, Alendronate - Romosozumab) was based on the Mantel-Haenszel method adjusted for age strata, baseline total hip BMD T-score (≤ -2.5, \> -2.5), and presence of severe vertebral fracture at baseline.~Positive values for absolute risk reduction favor romosozumab."||5.57|2.50|
70922418|NCT01631214|141335801|SUPERIORITY|The primary endpoints were tested at the 5% level (2-sided), accounting for multiplicity using the Hochberg procedure. If the larger of the 2 p-values was significant at the 0.05 level (2-sided), the statistical testing continued to the secondary endpoint in the testing sequence.|Hazard Ratio (HR)|0.73|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|0.61|0.88|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)|||0.88|0.61|<0.001
70922419|NCT01631214|141335802|SUPERIORITY|If the 2 primary endpoints and the specified BMD secondary endpoints were all significant, the nonvertebral fracture at the primary analysis was evaluated based on a 1-sided test (overall α=0.025) determined by the Lan-DeMets alpha spending function that approximates a Pocock boundary, 0.0233 (1-sided).|Hazard Ratio (HR)|0.81|STANDARD_ERROR_OF_MEAN|0.1||0.04|TWO_SIDED|95.0|0.66|0.99||The adjusted 2-sided p-value is reported.|Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.99|0.66|0.040
70977833|NCT03417440|141464097|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.1||0.22|ONE_SIDED|90.0|-0.1|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.1|0.22
70977834|NCT03417440|141464098|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_DEVIATION|1.3||0.46|ONE_SIDED|90.0|-0.3|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.3|0.46
70977835|NCT03417440|141464098|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|1.2||0.96|ONE_SIDED|90.0|-0.7|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.7|0.96
70977836|NCT03417440|141464098|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_DEVIATION|1.3||0.495|ONE_SIDED|90.0|-0.3|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.3|0.495
70977837|NCT03417440|141464099|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_DEVIATION|4.5||0.445|ONE_SIDED|90.0|-1.1|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.1|0.445
70977838|NCT03417440|141464099|SUPERIORITY||Mean Difference (Net)|-1.3|STANDARD_DEVIATION|4.4||0.92|ONE_SIDED|90.0|-2.5|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-2.5|0.92
70977839|NCT03417440|141464099|SUPERIORITY||Mean Difference (Net)|0.7|STANDARD_DEVIATION|4.5||0.23|ONE_SIDED|90.0|-0.5|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.5|0.23
70977840|NCT03417440|141464100|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|1.1||0.78|ONE_SIDED|90.0|-0.5|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.5|0.78
70977841|NCT03417440|141464100|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|1.1||0.98|ONE_SIDED|90.0|-0.7|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.7|0.98
70977842|NCT03417440|141464100|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.1||0.13|ONE_SIDED|90.0|-0.1|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.1|0.13
70977843|NCT03417440|141464101|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|4.3||0.285|ONE_SIDED|90.0||0.6||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided|||||0.6||0.285
70977844|NCT03417440|141464101|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_DEVIATION|4.3||0.5|ONE_SIDED|90.0||1.1||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided|||||1.1||0.50
70977845|NCT03417440|141464101|SUPERIORITY||Mean Difference (Net)|1.2|STANDARD_DEVIATION|4.3||0.92|ONE_SIDED|90.0||2.3||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided|||||2.3||0.92
70977846|NCT03417440|141464102|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_DEVIATION|4.2||0.42|ONE_SIDED|90.0|-0.9|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.9|0.42
71034450|NCT00796653|141578368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.871|STANDARD_ERROR_OF_MEAN|4.44|<|0.0001|TWO_SIDED|95.0|12.158|29.584|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||29.584|12.158|<0.0001
71034451|NCT00796653|141578368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.249|STANDARD_ERROR_OF_MEAN|4.454||0.0014|TWO_SIDED|95.0|5.506|22.991|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||22.991|5.506|0.0014
71034452|NCT00796653|141578368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.4|STANDARD_ERROR_OF_MEAN|4.463||0.0001|TWO_SIDED|95.0|8.64|26.16|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||26.160|8.640|0.0001
71034453|NCT00796653|141578368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.875|STANDARD_ERROR_OF_MEAN|4.444|<|0.0001|TWO_SIDED|95.0|14.153|31.596|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||31.596|14.153|<0.0001
71034454|NCT00796653|141578368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.816|STANDARD_ERROR_OF_MEAN|4.475||0.0004|TWO_SIDED|95.0|7.032|24.599|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||24.599|7.032|0.0004
70977847|NCT03417440|141464102|SUPERIORITY||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|4.2||0.82|ONE_SIDED|90.0|-1.9|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.9|0.82
70977848|NCT03417440|141464102|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_DEVIATION|4.2||0.58|ONE_SIDED|90.0|-1.2|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.2|0.58
70977849|NCT03417440|141464103|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_DEVIATION|4.0||0.45|ONE_SIDED|90.0|-0.9|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.9|0.45
70977850|NCT03417440|141464103|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_DEVIATION|3.9||0.49|ONE_SIDED|90.0|-1.0|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.0|0.49
70977851|NCT03417440|141464103|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|3.9||0.61|ONE_SIDED|90.0|-1.2|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.2|0.61
70977852|NCT03417440|141464104|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||.84
70977853|NCT03417440|141464104|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||.96
70977854|NCT03417440|141464104|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||.41
70977855|NCT03417440|141464105|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||.13
70977856|NCT03417440|141464105|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.20
70977857|NCT03417440|141464105|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||||||0.39
70977858|NCT03417440|141464106|OTHER||Spearman Correlation|-0.10435||||0.3116|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Self-efficacy for Physical Activity change and Daily Steps change across 4 months.||||0.3116
70977859|NCT03417440|141464106|OTHER||Spearman Correlation|0.17742||||0.0838|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Correlation between Self-regulation of Physical Activity change and Daily Steps change across 4 months.||||0.0838
70977860|NCT03417440|141464106|OTHER||Spearman Correlation|-0.09834||||0.351|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Family Social Support for Physical Activity change and Daily Steps change across 4 months.||||0.3510
70977861|NCT03417440|141464106|OTHER||Spearman Correlation|-0.04562||||0.6659|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Outcome Expectation for Physical Activity change and Daily Steps change across 4 months.||||0.6659
71034455|NCT00796653|141578369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.153|STANDARD_ERROR_OF_MEAN|0.121||0.2057|TWO_SIDED|95.0|-0.391|-0.084|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||-0.084|-0.391|0.2057
70977862|NCT03417440|141464106|OTHER||Spearman Correlation|-0.04831||||0.6402|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Aging Self-perceptions (Attitude Toward Own Aging) change and Daily Steps change across 4 months.||||0.6402
70977863|NCT03417440|141464106|OTHER||Spearman Correlation|0.13128||||0.2048|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Views of Aging--Psychosocial Loss change and Daily Steps change across 4 months.||||0.2048
70977864|NCT03417440|141464106|OTHER||Spearman Correlation|0.10022||||0.3445|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Views of Aging--Physical Change change and Daily Steps change across 4 months.||||0.3445
70977865|NCT03417440|141464106|OTHER||Spearman Correlation|-0.00866||||0.934|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Views of Aging--Psychological Growth change and Daily Steps change across 4 months.||||0.9340
70977866|NCT00670709|141464107|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-07||95.0|||||t-test, 2 sided|||||||<0.0000001
70977867|NCT00670709|141464108|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.005||95.0|||||t-test, 2 sided|||HD subjects vs control subjects||||<0.005
71034456|NCT00796653|141578369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.266|STANDARD_ERROR_OF_MEAN|0.121||0.0284|TWO_SIDED|95.0|-0.504|-0.028|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||-0.028|-0.504|0.0284
71034457|NCT00796653|141578369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.222|STANDARD_ERROR_OF_MEAN|0.122||0.0685|TWO_SIDED|95.0|-0.461|0.017|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||0.017|-0.461|0.0685
71034458|NCT00796653|141578369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.278|STANDARD_ERROR_OF_MEAN|0.152||0.0674|TWO_SIDED|95.0|-0.576|0.02|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||0.020|-0.576|0.0674
71034459|NCT00796653|141578369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.365|STANDARD_ERROR_OF_MEAN|0.0163||0.0163|TWO_SIDED|95.0|-0.662|-0.067|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||-0.067|-0.662|0.0163
71034460|NCT00796653|141578369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.153||0.0364|TWO_SIDED|95.0|-0.62|-0.02|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||-0.020|-0.620|0.0364
71034461|NCT00796653|141578369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.424|STANDARD_ERROR_OF_MEAN|0.254||0.0959|TWO_SIDED|95.0|-0.922|0.075|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use||0.075|-0.922|0.0959
71034462|NCT00796653|141578369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.616|STANDARD_ERROR_OF_MEAN|0.254||0.0155|TWO_SIDED|95.0|-1.115|-0.117|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use||-0.117|-1.115|0.0155
71034463|NCT00796653|141578369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.541|STANDARD_ERROR_OF_MEAN|0.256||0.0347|TWO_SIDED|95.0|-1.042|-0.039|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use||-0.039|-1.042|0.0347
70977868|NCT03304522|141464109|SUPERIORITY||Least Squares (LS) Mean Difference|-1.085|||<|0.0001|TWO_SIDED|95.0|-1.876|-0.293|||Mixed-effects Model for Repeated Measure|||||-0.293|-1.876|<0.0001
70977869|NCT03304522|141464112|SUPERIORITY||LS Mean Difference|-1.111|||<|0.0001|TWO_SIDED|95.0|-1.911|-0.312|||Mixed-effects Model for Repeated Measure|||||-0.312|-1.911|<0.0001
70977870|NCT03304522|141464114|SUPERIORITY||LS Mean Difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-1.5|0.3|||Mixed-effects Model for Repeated Measure|||||0.3|-1.5|<0.0001
70977871|NCT00885365|141464148|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority is shown if the lower limit of the two-sided 95% confidence interval is above the non-inferiority margin set at -4.5%.|difference of least square means|-0.5||||0.64|TWO_SIDED|95.0|-2.58|1.59|||ANCOVA|||Based on previous studies, the difference between reference and placebo after 4-week treatment is assumed to be about 12% and the non-inferiority margin safely placed at 4.5%. With a between-patient SD of 13.5% and estimated difference between treatments of zero, sample size of 143 per group allows a 80% power to show the non-inferiority of Bramitob® versus TOBI®. Accounting for an expected dropout rate of 11%, a minimum of 160 participants per group is required.||1.59|-2.58|0.640
70977872|NCT00885365|141464150|SUPERIORITY_OR_OTHER||difference of least square means|-0.01||||0.634|TWO_SIDED|95.0|-0.08|0.05|||ANCOVA|||Analysis for Week 4||0.05|-0.08|0.634
70977873|NCT00885365|141464151|SUPERIORITY_OR_OTHER||difference of least square means|-0.55||||0.63|TWO_SIDED|95.0|-2.78|1.69|||ANCOVA|||Analysis for Week 4||1.69|-2.78|0.630
70977874|NCT00885365|141464152|SUPERIORITY_OR_OTHER||difference of least square means|-0.02||||0.693|TWO_SIDED|95.0|-0.09|0.06|||ANCOVA|||Analysis for Week 4||0.06|-0.09|0.693
70977875|NCT00885365|141464153|SUPERIORITY_OR_OTHER||difference of least square means|0.51||||0.777|TWO_SIDED|95.0|-3.06|4.09|||ANCOVA|||Analysis for Week 4||4.09|-3.06|0.777
70977876|NCT00885365|141464154|SUPERIORITY_OR_OTHER||difference of least square means|0.04||||0.505|TWO_SIDED|95.0|-0.08|0.15|||ANCOVA|||Analysis for Week 4||0.15|-0.08|0.505
70977877|NCT00885365|141464155|SUPERIORITY_OR_OTHER||difference of least square means|0.04|STANDARD_ERROR_OF_MEAN|0.18||0.82|TWO_SIDED|95.0|-0.31|0.39||A priori threshold for statistical significance is \<= 0.050.|ANCOVA|treatment and country are fixed effects and baseline log10 bacterial load (CFU/g) value is a covariate||Analysis of Week 4 data||0.39|-0.31|0.820
70977878|NCT00885365|141464158|SUPERIORITY_OR_OTHER|||||||0.692||||||A priori threshold for statistical significance is \<= 0.050.|Cochran-Mantel-Haenszel|Test controlling for country.||Week 4||||0.692
70977879|NCT00885365|141464158|SUPERIORITY_OR_OTHER|||||||0.128||||||A priori threshold for statistical significance is \<= 0.050.|Cochran-Mantel-Haenszel|Test controlling for country.||Week 8||||0.128
70977880|NCT02507349|141464169|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Time-by-treatment interaction||||<0.0001
70977881|NCT02507349|141464169|SUPERIORITY|||||||0.0033|||||||Mixed Models Analysis|||Three-way interaction effect (treatment, polynomial time, and age group 1) where age group 1 is defined by 0 (reference) if \<=35; 1 if (35\<age\<=49); 2 if age \>49.||||0.0033
70977882|NCT02507349|141464169|SUPERIORITY|||||||0.3164|||||||Mixed Models Analysis|||Three-way interaction effect (treatment, polynomial time, and SMI group). Participants with a diagnosis of major depression, schizoaffective or schizophrenia were classified into the SMI group and the reference group (Non-SMI) included diagnosis of anxiety, PTSD, depression/dysthymia/depression nos.||||0.3164
70977883|NCT02507349|141464169|SUPERIORITY|||||||0.0482|||||||Mixed Models Analysis|||Three-way interaction effect of time, treatment, and the basis subgroups (no symptoms =group 1; at least 1 severe symptom = group 2)||||0.0482
70977884|NCT02507349|141464169|SUPERIORITY|||||||0.9928|||||||Mixed Models Analysis|||Three-way interaction of Treatment, time, and subgroup of side effects. Subgroup of side effect= 0 if the response to the medication side effects question at baseline is 1, 2, or 3 (i.e. subgroup of participants who are minimally bothered by medication side effects at baseline); Subgroup of side effect= 1 if the response to the medication side effects question at baseline is 4-10 (i.e. subgroup of participants who are moderately or very bothered by medication side effects at baseline)||||0.9928
71034464|NCT00796653|141578370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0164||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.0|-0.4|0.0164
70977885|NCT02507349|141464170|SUPERIORITY|||||||0.6243|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.6243
70977886|NCT02507349|141464170|SUPERIORITY|||||||0.1969|||||||Mixed Models Analysis|||Test for change over time from baseline (Marginal Effect of Time)||||0.1969
70977887|NCT02507349|141464170|SUPERIORITY|||||||0.0042|||||||Mixed Models Analysis|||Three-way interaction effect (treatment, polynomial time, and age group 1) where age group 1 is defined by 0 (reference) if \<=35; 1 if (35\<age\<=49); 2 if age \>49||||0.0042
70977888|NCT02507349|141464170|SUPERIORITY|||||||0.0002|||||||Mixed Models Analysis|||Three-way interaction effect (treatment, polynomial time, and SMI group). Participants with a diagnosis of major depression, schizoaffective or schizophrenia were classified into the SMI group and the reference group (Non-SMI) included diagnosis of anxiety, PTSD, depression/dysthymia/depression nos.||||0.0002
70977889|NCT02507349|141464170|SUPERIORITY|||||||0.7254|||||||Mixed Models Analysis|||Three-way interaction effect of time, treatment, and the basis subgroups (no symptoms =group 1; at least 1 severe symptom = group 2)||||0.7254
70977890|NCT02507349|141464170|SUPERIORITY|||||||0.058|||||||Mixed Models Analysis|||Three-way interaction of Treatment, time, and subgroup of side effects. Subgroup of side effect= 0 if the response to the medication side effects question at baseline is 1, 2, or 3 (i.e. subgroup of participants who are minimally bothered by medication side effects at baseline); Subgroup of side effect= 1 if the response to the medication side effects question at baseline is 4-10 (i.e. subgroup of participants who are moderately or very bothered by medication side effects at baseline)||||0.0580
70977891|NCT02507349|141464171|SUPERIORITY|||||||0.4677|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.4677
70977892|NCT02507349|141464171|SUPERIORITY|||||||0.094|||||||Mixed Models Analysis|||Test for change over time from baseline (Marginal Effect of Time)||||0.0940
70977893|NCT02507349|141464172|SUPERIORITY|||||||0.8733|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.8733
70922420|NCT01631214|141335803|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.65|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|0.56|0.76|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.76|0.56|<0.001
70977894|NCT02507349|141464172|SUPERIORITY|||||||0.0113|||||||Mixed Models Analysis|||Test for change over time from baseline (Marginal Effect of Time)||||0.0113
70977895|NCT02507349|141464173|SUPERIORITY|||||||0.2328|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.2328
70977896|NCT02507349|141464173|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|||Test for change over time from baseline (Marginal Effect of Time)||||0.0005
70977897|NCT02507349|141464174|SUPERIORITY|||||||0.0033|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.0033
70977898|NCT02507349|141464175|SUPERIORITY|||||||0.1649|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.1649
70977899|NCT02507349|141464175|SUPERIORITY|||||||0.0016|||||||Mixed Models Analysis|||Test for change over time from baseline (Marginal Effect of Time)||||0.0016
70977900|NCT02507349|141464176|SUPERIORITY|||||||0.008|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.0080
70977901|NCT02507349|141464177|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
70977902|NCT02507349|141464178|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|||||||0.0003
70977903|NCT00888238|141464179|SUPERIORITY_OR_OTHER||Least Squares Mean|1.7|||<|0.001||90.0|1.47|1.93|||ANOVA|||||1.93|1.47|<0.001
70977904|NCT00888238|141464180|SUPERIORITY_OR_OTHER||Least Squares Mean|1.3|||<|0.001||90.0|1.08|1.52|||ANOVA|||||1.52|1.08|<0.001
70977905|NCT01748799|141464183|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||The level for statistical significance was p\< 0.05.|ANOVA|||Omnibus analysis for Cannabis Withdrawal Scale (CWS) data was a Repeated measures ANOVA (including all the experimental conditions) followed by pair-wise comparisons. The level for statistical significance was p\< 0.05.||||<0.01
70977906|NCT01748799|141464183|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||The level for statistical significance was p\< 0.05.|ANOVA|||Omnibus analysis for Cannabis Withdrawal Checklist (CWC) data was a Repeated measures ANOVA (including all the experimental conditions) followed by pair-wise comparisons. The level for statistical significance was p\< 0.05.||||0.01
70977907|NCT00516919|141464184|SUPERIORITY_OR_OTHER_LEGACY||F statistic|0.45|||=|0.51||95.0|||||ANCOVA|Covariate = Baseline (pre-treatment) BMI; Degrees of freedom = (1, 76)||Test for group differences in BMI at post-treatment, controlling for baseline BMI.||||=0.51
70977908|NCT00516919|141464184|SUPERIORITY_OR_OTHER_LEGACY||F statistic|0.69|||=|0.41||95.0|||||ANCOVA|Covariate = Baseline (pre-treatment) BMI; Degrees of freedom = (1, 76)||Test for group differences in BMI at 6-month follow-up, controlling for baseline BMI.||||=0.41
70977909|NCT03371355|141464185|SUPERIORITY||Mean Difference in % CFB|-24.0||||0.0343|TWO_SIDED|95.0|-41.0|-2.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|||-2|-41|0.0343
70977910|NCT03371355|141464185|SUPERIORITY||Mean Difference in % CFB|-44.0|||<|0.0001|TWO_SIDED|95.0|-56.0|-28.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|||-28|-56|<0.0001
70977911|NCT03371355|141464185|SUPERIORITY||Mean Difference in % CFB|-37.0||||0.0009|TWO_SIDED|95.0|-52.0|-17.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|||-17|-52|0.0009
71034465|NCT00796653|141578370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0196||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.0|-0.4|0.0196
71034466|NCT00796653|141578370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0041||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||-0.1|-0.5|0.0041
70977912|NCT03371355|141464186|SUPERIORITY||Least Squares Mean Difference|-49.87|||<|0.0001|TWO_SIDED|95.0|-62.68|-37.06|||ANCOVA|||||-37.06|-62.68|<0.0001
70977913|NCT03371355|141464186|SUPERIORITY||Least Squares Mean Difference|-71.66|||<|0.0001|TWO_SIDED|95.0|-84.47|-58.85|||ANCOVA|||||-58.85|-84.47|<0.0001
70977914|NCT03371355|141464186|SUPERIORITY||Least Squares Mean Difference|-59.74|||<|0.0001|TWO_SIDED|95.0|-74.04|-45.44|||ANCOVA|||||-45.44|-74.04|<0.0001
70977915|NCT03371355|141464187|SUPERIORITY||Least Squares Mean Difference|-16.5||||0.0327|TWO_SIDED|95.0|-31.59|-1.39|||ANCOVA|||TC||-1.39|-31.59|0.0327
70977916|NCT03371355|141464187|SUPERIORITY||Least Squares Mean Difference|-37.0|||<|0.0001|TWO_SIDED|95.0|-52.15|-21.94|||ANCOVA|||TC||-21.94|-52.15|<0.0001
70977917|NCT03371355|141464187|SUPERIORITY||Least Squares Mean Difference|-31.6||||0.0003|TWO_SIDED|95.0|-48.23|-15.05|||ANCOVA|||TC||-15.05|-48.23|0.0003
70977918|NCT03371355|141464187|SUPERIORITY||Least Squares Mean Difference|7.5||||0.256|TWO_SIDED|95.0|-5.55|20.54|||ANCOVA|||LDL-C||20.54|-5.55|0.2560
70977919|NCT03371355|141464187|SUPERIORITY||Least Squares Mean Difference|-8.6||||0.1795|TWO_SIDED|95.0|-21.26|4.05|||ANCOVA|||LDL-C||4.05|-21.26|0.1795
70977920|NCT03371355|141464187|SUPERIORITY||Least Squares Mean Difference|-8.8||||0.2065|TWO_SIDED|95.0|-22.48|4.95|||ANCOVA|||LDL-C||4.95|-22.48|0.2065
70977921|NCT03371355|141464187|SUPERIORITY||Least Squares Mean Difference|-2.7||||0.1515|TWO_SIDED|95.0|-6.43|1.01|||ANCOVA|||HDL-C||1.01|-6.43|0.1515
70977922|NCT03371355|141464187|SUPERIORITY||Least Squares Mean Difference|-8.6|||<|0.0001|TWO_SIDED|95.0|-12.29|-4.91|||ANCOVA|||HDL-C||-4.91|-12.29|<0.0001
70977923|NCT03371355|141464187|SUPERIORITY||Least Squares Mean Difference|-4.1||||0.0436|TWO_SIDED|95.0|-8.18|-0.12|||ANCOVA|||HDL-C||-0.12|-8.18|0.0436
70977924|NCT03371355|141464187|SUPERIORITY||Least Squares Mean Difference|-9.1||||0.0224|TWO_SIDED|95.0|-16.94|-1.33|||ANCOVA|||VLDL-C||-1.33|-16.94|0.0224
70977925|NCT03371355|141464187|SUPERIORITY||Least Squares Mean Difference|-15.4||||0.0001|TWO_SIDED|95.0|-22.94|-7.84|||ANCOVA|||VLDL-C||-7.84|-22.94|0.0001
71034467|NCT00796653|141578371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0388||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.0|-0.4|0.0388
71096090|NCT01795937|141700810|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|180.63|STANDARD_DEVIATION|14.5|||TWO_SIDED|90.0|165.68|196.93|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison faldaprevir+itraconazole : faldaprevir.||196.93|165.68|
71096091|NCT01795937|141700811|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|946.45|STANDARD_DEVIATION|27.3|||TWO_SIDED|90.0|797.61|1123.07|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison atorvastatin+faldaprevir : atorvastatin.||1123.07|797.61|
71096092|NCT01795937|141700812|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|3372.72|STANDARD_DEVIATION|20.5|||TWO_SIDED|90.0|2961.95|3840.47|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison atorvastatin+faldaprevir : atorvastatin.||3840.47|2961.95|
70977926|NCT03371355|141464187|SUPERIORITY||Least Squares Mean Difference|-10.8||||0.0091|TWO_SIDED|95.0|-18.86|-2.78|||ANCOVA|||VLDL-C||-2.78|-18.86|0.0091
70977927|NCT03371355|141464187|SUPERIORITY||Least Squares Mean Difference|-13.9||||0.0748|TWO_SIDED|95.0|-29.12|1.42|||ANCOVA|||Non-HDL-C||1.42|-29.12|0.0748
70977928|NCT03371355|141464187|SUPERIORITY||Least Squares Mean Difference|-28.4||||0.0004|TWO_SIDED|95.0|-43.68|-13.18|||ANCOVA|||Non-HDL-C||-13.18|-43.68|0.0004
70977929|NCT03371355|141464187|SUPERIORITY||Least Squares Mean Difference|-27.4||||0.0016|TWO_SIDED|95.0|-44.08|-10.64|||ANCOVA|||Non-HDL-C||-10.64|-44.08|0.0016
70977930|NCT03371355|141464187|SUPERIORITY||Least Squares Mean Difference|-2.44||||0.6005|TWO_SIDED|95.0|-11.68|6.8|||ANCOVA|||ApoB||6.80|-11.68|0.6005
70977931|NCT03371355|141464187|SUPERIORITY||Least Squares Mean Difference|-9.83||||0.0374|TWO_SIDED|95.0|-19.07|-0.59|||ANCOVA|||ApoB||-0.59|-19.07|0.0374
70977932|NCT03371355|141464187|SUPERIORITY||Least Squares Mean Difference|-5.28||||0.31|TWO_SIDED|95.0|-15.55|5.0|||ANCOVA|||ApoB||5.00|-15.55|0.3100
70977933|NCT03371355|141464187|SUPERIORITY||Least Squares Mean Difference|-1.002||||0.0728|TWO_SIDED|95.0|-2.1|0.09|||ANCOVA|||ApoB-48||0.09|-2.10|0.0728
70977934|NCT03371355|141464187|SUPERIORITY||Least Squares Mean Difference|-1.803||||0.0018|TWO_SIDED|95.0|-2.91|-0.69|||ANCOVA|||ApoB-48||-0.69|-2.91|0.0018
70977935|NCT03371355|141464187|SUPERIORITY||Least Squares Mean Difference|-1.091||||0.0759|TWO_SIDED|95.0|-2.3|0.12|||ANCOVA|||ApoB-48||0.12|-2.30|0.0759
70977936|NCT03371355|141464187|SUPERIORITY||Least Squares Mean Difference|-0.887||||0.8451|TWO_SIDED|95.0|-9.89|8.11|||ANCOVA|||ApoB-100||8.11|-9.89|0.8451
70977937|NCT03371355|141464187|SUPERIORITY||Least Squares Mean Difference|-7.59||||0.0973|TWO_SIDED|95.0|-16.59|1.41|||ANCOVA|||ApoB-100||1.41|-16.59|0.0973
70977938|NCT03371355|141464187|SUPERIORITY||Least Squares Mean Difference|-3.418||||0.5|TWO_SIDED|95.0|-13.45|6.61|||ANCOVA|||ApoB-100||6.61|-13.45|0.5000
70977939|NCT03371355|141464187|SUPERIORITY||Least Squares Mean Difference|-4.753||||0.0008|TWO_SIDED|95.0|-7.47|-2.03|||ANCOVA|||ApoCIII||-2.03|-7.47|0.0008
70977940|NCT03371355|141464187|SUPERIORITY||Least Squares Mean Difference|-8.499|||<|0.0001|TWO_SIDED|95.0|-11.18|-5.82|||ANCOVA|||ApoCIII||-5.82|-11.18|<0.0001
70977941|NCT03371355|141464187|SUPERIORITY||Least Squares Mean Difference|-6.86|||<|0.0001|TWO_SIDED|95.0|-9.78|-3.93|||ANCOVA|||ApoCIII||-3.93|-9.78|<0.0001
70977942|NCT03371355|141464187|SUPERIORITY||Least Squares Mean Difference|-16.8||||0.0003|TWO_SIDED|95.0|-25.8|-7.85|||ANCOVA|||ApoA1||-7.85|-25.80|0.0003
70977943|NCT03371355|141464187|SUPERIORITY||Least Squares Mean Difference|-35.2|||<|0.0001|TWO_SIDED|95.0|-44.07|-26.24|||ANCOVA|||ApoA1||-26.24|-44.07|<0.0001
70977944|NCT03371355|141464187|SUPERIORITY||Least Squares Mean Difference|-21.1|||<|0.0001|TWO_SIDED|95.0|-30.89|-11.39|||ANCOVA|||ApoA1||-11.39|-30.89|<0.0001
70977945|NCT03371355|141464188|SUPERIORITY||Least Squares Mean Difference|0.0128||||0.8299|TWO_SIDED|95.0|-0.1|0.13|||ANCOVA|||||0.13|-0.10|0.8299
70977946|NCT03371355|141464188|SUPERIORITY||Least Squares Mean Difference|-0.0144||||0.8102|TWO_SIDED|95.0|-0.13|0.1|||ANCOVA|||||0.10|-0.13|0.8102
70977947|NCT03371355|141464188|SUPERIORITY||Least Squares Mean Difference|-0.0146||||0.8223|TWO_SIDED|95.0|-0.14|0.11|||ANCOVA|||||0.11|-0.14|0.8223
70977948|NCT03371355|141464189|SUPERIORITY||Least Squares Mean Difference|7.8||||0.0604|TWO_SIDED|95.0|-0.35|16.02|||ANCOVA|||Lp(a)||16.02|-0.35|0.0604
70977949|NCT03371355|141464189|SUPERIORITY||Least Squares Mean Difference|1.6||||0.7048|TWO_SIDED|95.0|-6.61|9.74|||ANCOVA|||Lp(a)||9.74|-6.61|0.7048
70977950|NCT03371355|141464189|SUPERIORITY||Least Squares Mean Difference|-1.7||||0.7024|TWO_SIDED|95.0|-10.65|7.2|||ANCOVA|||Lp(a)||7.20|-10.65|0.7024
70977951|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|-45.0|||<|0.0001|TWO_SIDED|95.0|-54.0|-33.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ANGPTL3||-33|-54|<0.0001
70977952|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|-62.0|||<|0.0001|TWO_SIDED|95.0|-69.0|-54.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ANGPTL3||-54|-69|<0.0001
71034468|NCT00796653|141578371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0038||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.1|-0.5|0.0038
71034469|NCT00796653|141578371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0053||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||-0.1|-0.5|0.0053
71096093|NCT01795937|141700815|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|1358.91|STANDARD_DEVIATION|16.4|||TWO_SIDED|90.0|1224.32|1508.29|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison atorvastatin+faldaprevir : atorvastatin.||1508.29|1224.32|
71034470|NCT00796653|141578372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0555||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||0.0|-0.4|0.0555
71034471|NCT00796653|141578372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0122||95.0|-0.4|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.1|-0.4|0.0122
71034472|NCT00796653|141578372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0144||95.0|-0.4|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||-0.1|-0.4|0.0144
71034473|NCT00796653|141578373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.5707||95.0|-0.3|0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||0.1|-0.3|0.5707
71034474|NCT00796653|141578373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0814||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||0.0|-0.4|0.0814
71034475|NCT00796653|141578373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.7413||95.0|-0.2|0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||0.2|-0.2|0.7413
71096094|NCT01795937|141700816|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|1466.35|STANDARD_DEVIATION|23.3|||TWO_SIDED|90.0|1277.62|1682.95|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison rosuvastatin+faldaprevir : rosuvastatin.||1682.95|1277.62|
70922421|NCT01631214|141335804|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Odds Ratio (OR)|0.49|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|0.37|0.64|||Regression, Logistic|Based on logistic regression model adjusted for age strata, baseline total hip BMD T-score and presence of severe vertebral fracture at baseline.|Values \< 1 for odds ratio favor romosozumab. The standard error (SE) represents the standard error of log(odds ratio).|||0.64|0.37|<0.001
70922422|NCT01631214|141335804|SUPERIORITY||Risk Ratio (RR)|0.52|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.4|0.66|||||SE represents the standard error of log (risk ratio).|"The risk ratio (ratio of percentages, Romosozumab:Alendronate) was based on the Mantel Haenszel method, adjusted for age strata (\<75 vs. ≥75 years), the presence or absence of severe vertebral fracture at baseline, and baseline bone mineral density T-score at the total hip (≤ -2.5, \> -2.5).~Values \< 1 for risk ratio favor romosozumab."||0.66|0.40|
70922423|NCT01631214|141335804|SUPERIORITY||Absolute risk reduction|4.44|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|95.0|2.8|6.08||||||"The absolute risk reduction (difference in percentages, Alendronate - Romosozumab) was based on the Mantel-Haenszel method adjusted for age strata, baseline total hip BMD T-score (≤ -2.5, \> -2.5), and presence of severe vertebral fracture at baseline.~Positive values for absolute risk reduction favor romosozumab."||6.08|2.80|
70922424|NCT01631214|141335805|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.73|STANDARD_ERROR_OF_MEAN|0.11||0.004|TWO_SIDED|95.0|0.59|0.9|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.90|0.59|0.004
70922425|NCT01631214|141335806|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.62|STANDARD_ERROR_OF_MEAN|0.2||0.015|TWO_SIDED|95.0|0.42|0.92|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.92|0.42|0.015
70922426|NCT01631214|141335807|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Odds Ratio (OR)|0.51|STANDARD_ERROR_OF_MEAN|0.25||0.008|TWO_SIDED|95.0|0.31|0.85|||Regression, Logistic|Based on logistic regression model adjusted for age strata, baseline total hip BMD T-score and presence of severe vertebral fracture at baseline.|Values \< 1 for odds ratio favor romosozumab. The standard error (SE) represents the standard error of log(odds ratio).|||0.85|0.31|0.008
70922427|NCT01631214|141335807|SUPERIORITY||Risk Ratio (RR)|0.52|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|95.0|0.32|0.85|||||SE represents the standard error of log (risk ratio).|"The risk ratio (ratio of percentages, Romosozumab:Alendronate) was based on the Mantel Haenszel method, adjusted for age strata (\<75 vs. ≥75 years), the presence or absence of severe vertebral fracture at baseline, and baseline bone mineral density T-score at the total hip (≤ -2.5, \> -2.5).~Values \< 1 for risk ratio favor romosozumab."||0.85|0.32|
70922428|NCT01631214|141335807|SUPERIORITY||Absolute risk reduction|1.21|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|0.33|2.1||||||"The absolute risk reduction (difference in percentages, Alendronate - Romosozumab) was based on the Mantel-Haenszel method adjusted for age strata, baseline total hip BMD T-score (≤ -2.5, \> -2.5), and presence of severe vertebral fracture at baseline.~Positive values for absolute risk reduction favor romosozumab."||2.10|0.33|
70922429|NCT01631214|141335808|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.74|STANDARD_ERROR_OF_MEAN|0.11||0.005|TWO_SIDED|95.0|0.59|0.91|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.91|0.59|0.005
70977953|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|-58.0|||<|0.0001|TWO_SIDED|95.0|-66.0|-47.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ANGPTL3||-47|-66|<0.0001
70977954|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|-9.0||||0.0309|TWO_SIDED|95.0|-16.0|-1.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|TC||-1|-16|0.0309
71034476|NCT00796653|141578374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.437|STANDARD_ERROR_OF_MEAN|0.305||0.1524||95.0|-0.162|1.036|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.036|-0.162|0.1524
71034477|NCT00796653|141578374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.706|STANDARD_ERROR_OF_MEAN|0.306||0.0211||95.0|0.106|1.307|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.307|0.106|0.0211
70922430|NCT01631214|141335809|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.81|STANDARD_ERROR_OF_MEAN|0.12||0.074|TWO_SIDED|95.0|0.64|1.02|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||1.02|0.64|0.074
70922431|NCT01631214|141335810|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.72|STANDARD_ERROR_OF_MEAN|0.24||0.17|TWO_SIDED|95.0|0.46|1.15|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||1.15|0.46|0.17
70922432|NCT01631214|141335811|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.41|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|0.24|0.71|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.71|0.24|<0.001
70922433|NCT01631214|141335812|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.72|STANDARD_ERROR_OF_MEAN|0.15||0.027|TWO_SIDED|95.0|0.54|0.96|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.96|0.54|0.027
70922434|NCT01631214|141335813|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Odds Ratio (OR)|0.63|STANDARD_ERROR_OF_MEAN|0.18||0.008|TWO_SIDED|95.0|0.44|0.89|||Regression, Logistic|Based on a logistic regression model adjusted for age strata, baseline total hip BMD T-score and presence of severe vertebral fracture at baseline.|Values \< 1 for odds ratio favor romosozumab. The standard error (SE) represents the standard error of log(odds ratio).|||0.89|0.44|0.008
70922435|NCT01631214|141335813|SUPERIORITY||Risk Ratio (RR)|0.64|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|0.46|0.89|||||SE represents the standard error of log (risk ratio).|"The risk ratio (ratio of percentages, Romosozumab:Alendronate) was based on the Mantel Haenszel method, adjusted for age strata (\<75 vs. ≥75 years), the presence or absence of severe vertebral fracture at baseline, and baseline bone mineral density T-score at the total hip (≤ -2.5, \> -2.5).~Values \< 1 for risk ratio favor romosozumab."||0.89|0.46|
70922436|NCT01631214|141335813|SUPERIORITY||Absolute risk reduction|1.84|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|95.0|0.51|3.17||||||"The absolute risk reduction (difference in percentages, Alendronate - Romosozumab) was based on the Mantel-Haenszel method adjusted for age strata, baseline total hip BMD T-score (≤ -2.5, \> -2.5), and presence of severe vertebral fracture at baseline.~Positive values for absolute risk reduction favor romosozumab."||3.17|0.51|
70922437|NCT01631214|141335814|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.71|STANDARD_ERROR_OF_MEAN|0.11||0.002|TWO_SIDED|95.0|0.57|0.88|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.88|0.57|0.002
70922438|NCT01631214|141335815|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.74|STANDARD_ERROR_OF_MEAN|0.16||0.057|TWO_SIDED|95.0|0.54|1.01|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||1.01|0.54|0.057
71034478|NCT00796653|141578374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.464|STANDARD_ERROR_OF_MEAN|0.307||0.1314||95.0|-0.139|1.066|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.066|-0.139|0.1314
71096095|NCT01795937|141700817|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|3288.7|STANDARD_DEVIATION|28.5|||TWO_SIDED|90.0|2782.04|3887.63|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison rosuvastatin+faldaprevir : rosuvastatin.||3887.63|2782.04|
71096096|NCT01795937|141700818|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|1678.23|STANDARD_DEVIATION|22.6|||TWO_SIDED|90.0|1468.52|1917.89|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison rosuvastatin+faldaprevir : rosuvastatin.||1917.89|1468.52|
71096097|NCT00983957|141700831|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.105|||||TWO_SIDED|90.0|1.023|1.195|||||Point estimates and 90% Confidence Interval (CIs) for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.||1.195|1.023|
70977955|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|-19.0|||<|0.0001|TWO_SIDED|95.0|-26.0|-12.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|TC||-12|-26|<0.0001
70977956|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|-17.0|||<|0.0001|TWO_SIDED|95.0|-25.0|-9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|TC||-9|-25|<0.0001
70977957|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|6.0||||0.4016|TWO_SIDED|95.0|-7.0|21.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||21|-7|0.4016
70977958|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|-7.0||||0.2589|TWO_SIDED|95.0|-18.0|6.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||6|-18|0.2589
70977959|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|-12.0||||0.0616|TWO_SIDED|95.0|-24.0|1.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||1|-24|0.0616
70977960|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|-8.0||||0.1918|TWO_SIDED|95.0|-18.0|4.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||4|-18|0.1918
70977961|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|-24.0|||<|0.0001|TWO_SIDED|95.0|-32.0|-14.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||-14|-32|<0.0001
70977962|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|-10.0||||0.1132|TWO_SIDED|95.0|-21.0|3.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||3|-21|0.1132
70977963|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|-24.0||||0.0177|TWO_SIDED|95.0|-40.0|-5.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-5|-40|0.0177
70977964|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|-38.0|||<|0.0001|TWO_SIDED|95.0|-51.0|-23.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-23|-51|<0.0001
70977965|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|-30.0||||0.0033|TWO_SIDED|95.0|-45.0|-12.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-12|-45|0.0033
70977966|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|-10.0||||0.0523|TWO_SIDED|95.0|-18.0|0.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||0|-18|0.0523
70977967|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|-18.0||||0.0002|TWO_SIDED|95.0|-26.0|-9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||-9|-26|0.0002
70977968|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|-19.0||||0.0004|TWO_SIDED|95.0|-28.0|-9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||-9|-28|0.0004
70977969|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|-3.0||||0.4204|TWO_SIDED|95.0|-12.0|5.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||5|-12|0.4204
71096098|NCT00983957|141700832|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.071|||||TWO_SIDED|90.0|0.988|1.16|||||Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.||1.160|0.988|
71096099|NCT00983957|141700833|SUPERIORITY_OR_OTHER||Adjusted geometric mean|1.009|||||TWO_SIDED|90.0|0.951|1.07|||||Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.||1.070|0.951|
71096100|NCT00983957|141700834|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.121|||||TWO_SIDED|90.0|1.018|1.234|||||Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.||1.234|1.018|
71096101|NCT00983957|141700837|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.059|||||TWO_SIDED|90.0|0.988|1.135|||||Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.||1.135|0.988|
71096102|NCT00983957|141700842|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.115|||||TWO_SIDED|90.0|1.063|1.171|||||Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.||1.171|1.063|
70977970|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|-9.0||||0.0441|TWO_SIDED|95.0|-16.0|0.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||0|-16|0.0441
70977971|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|-7.0||||0.1324|TWO_SIDED|95.0|-16.0|2.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||2|-16|0.1324
70977972|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|-29.0||||0.1009|TWO_SIDED|95.0|-53.0|7.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB-48||7|-53|0.1009
70977973|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|-52.0||||0.0005|TWO_SIDED|95.0|-68.0|-28.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB-48||-28|-68|0.0005
70977974|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|-21.0||||0.3004|TWO_SIDED|95.0|-50.0|24.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB-48||24|-50|0.3004
70977975|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|-2.0||||0.6135|TWO_SIDED|95.0|-10.0|7.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB-100||7|-10|0.6135
70977976|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|-7.0||||0.1127|TWO_SIDED|95.0|-15.0|2.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB-100||2|-15|0.1127
70977977|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|-5.0||||0.2576|TWO_SIDED|95.0|-14.0|4.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB-100||4|-14|0.2576
70977978|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|-36.0||||0.0017|TWO_SIDED|95.0|-52.0|-16.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoCIII||-16|-52|0.0017
70977979|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|-58.0|||<|0.0001|TWO_SIDED|95.0|-68.0|-45.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoCIII||-45|-68|<0.0001
70977980|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|-47.0|||<|0.0001|TWO_SIDED|95.0|-61.0|-29.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoCIII||-29|-61|<0.0001
70977981|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|-11.0||||0.0193|TWO_SIDED|95.0|-20.0|-2.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoAI||-2|-20|0.0193
70977982|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|-26.0|||<|0.0001|TWO_SIDED|95.0|-33.0|-19.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoAI||-19|-33|<0.0001
70977983|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|-14.0||||0.0063|TWO_SIDED|95.0|-23.0|-4.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoAI||-4|-23|0.0063
70977984|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|-2.0||||0.8873|TWO_SIDED|95.0|-21.0|23.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|FFA||23|-21|0.8873
70977985|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB|-8.0||||0.4404|TWO_SIDED|95.0|-27.0|15.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|FFA||15|-27|0.4404
70977986|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB]|-1.0||||0.9665|TWO_SIDED|95.0|-22.0|27.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|FFA||27|-22|0.9665
70977987|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB]|-7.0||||0.4133|TWO_SIDED|95.0|-21.0|10.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|Lp\[a\]||10|-21|0.4133
71096103|NCT03676725|141700931|SUPERIORITY||Odds Ratio (OR)|5.17||||0.017|ONE_SIDED||||||Fisher Exact|||Women with PMS vs. without PMS.||||0.017
71096104|NCT03676725|141700931|SUPERIORITY||Odds Ratio (OR)|16.0||||0.001|TWO_SIDED||||||Fisher Exact|||Women with PMS and with ADHD vs. other women||||0.001
71096105|NCT03676725|141700931|SUPERIORITY||Odds Ratio (OR)|0.86||||0.8|TWO_SIDED||||||Fisher Exact|||ADHD vs. no ADHD||||0.8
70977988|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB]|-6.0||||0.475|TWO_SIDED|95.0|-20.0|11.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|Lp\[a\]||11|-20|0.4750
70977989|NCT03371355|141464190|SUPERIORITY||Mean Difference in % CFB]|-4.0||||0.6354|TWO_SIDED|95.0|-20.0|15.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|Lp\[a\]||15|-20|0.6354
70977990|NCT03371355|141464191|SUPERIORITY||Least Squares Mean Difference|-17.2||||0.1799|TWO_SIDED|95.0|-42.53|8.1|||ANCOVA|||||8.10|-42.53|0.1799
70977991|NCT03371355|141464191|SUPERIORITY||Least Squares Mean Difference|13.8||||0.2867|TWO_SIDED|95.0|-11.83|39.49|||ANCOVA|||||39.49|-11.83|0.2867
70977992|NCT03371355|141464191|SUPERIORITY||Least Squares Mean Difference|2.2||||0.8812|TWO_SIDED|95.0|-26.78|31.14|||ANCOVA|||||31.14|-26.78|0.8812
70977993|NCT03371355|141464192|SUPERIORITY||Least Squares Mean Difference|-0.28||||0.3995|TWO_SIDED|95.0|-0.94|0.38|||ANCOVA|||||0.38|-0.94|0.3995
70977994|NCT03371355|141464192|SUPERIORITY||Least Squares Mean Difference|0.08||||0.8155|TWO_SIDED|95.0|-0.59|0.75|||ANCOVA|||||0.75|-0.59|0.8155
70977995|NCT03371355|141464192|SUPERIORITY||Least Squares Mean Difference|0.16||||0.6466|TWO_SIDED|95.0|-0.54|0.86|||ANCOVA|||||0.86|-0.54|0.6466
71096106|NCT01579305|141700938|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is pre-defined as 15% i.e., if the difference in responder rates is significantly greater than -15% (i.e., the lower confidence limit is greater than -15%), statistical non-inferiority of VOLBELLA® to Restylane-L® is established.|Difference in responder rates|4.9|||||ONE_SIDED|97.5|-6.7||||||Difference in responder rates is calculated as the responder rate at Month 3 for VOLBELLA® minus the responder rate at Month 3 for Restylane-L®.|The null hypothesis is that VOLBELLA® is inferior to Restylane-L® in terms of responder rate at Month 3, and the alternative hypothesis is that VOLBELLA® is inferior to Restylane-L® in terms of responder rate at Month 3 with 15% pre-defined non-inferiority margin. To test the null hypothesis, a difference in responder rates of these products (VOLBELLA® - Restylane-L®) at Month 3 and a 1-sided 97.5% Wald confidence interval for the difference is calculated.|||-6.7|
71096107|NCT02070991|141700958|SUPERIORITY_OR_OTHER||Difference between maci. and placebo|10.08||||0.3372|TWO_SIDED|95.0|-15.07|33.26|||Fisher Exact|||||33.26|-15.07|0.3372
70977996|NCT03371355|141464193|SUPERIORITY||Least Squares Mean Difference|1.39||||0.7393|TWO_SIDED|95.0|-9.66|6.89|||ANCOVA|||||6.89|-9.66|0.7393
70977997|NCT03371355|141464193|SUPERIORITY||Least Squares Mean Difference|-0.13||||0.9744|TWO_SIDED|95.0|-8.45|8.18|||ANCOVA|||||8.18|-8.45|0.9744
70977998|NCT03371355|141464193|SUPERIORITY||Least Squares Mean Difference|3.58||||0.4477|TWO_SIDED|95.0|-5.75|12.91|||ANCOVA|||||12.91|-5.75|0.4477
70977999|NCT03371355|141464194|SUPERIORITY||Least Squares Mean Difference|-1.794||||0.471|TWO_SIDED|95.0|-6.72|3.14|||ANCOVA|||||3.14|-6.72|0.4710
70978000|NCT03371355|141464194|SUPERIORITY||Least Squares Mean Difference|0.26||||0.9169|TWO_SIDED|95.0|-4.68|5.2|||ANCOVA|||||5.20|-4.68|0.9169
70978001|NCT03371355|141464194|SUPERIORITY||Least Squares Mean Difference|2.133||||0.4484|TWO_SIDED|95.0|-3.44|7.7|||ANCOVA|||||7.70|-3.44|0.4484
71096108|NCT02070991|141700959|SUPERIORITY_OR_OTHER||Treatment effect (ratio of geom. means)|0.77|||||TWO_SIDED|95.0|0.55|1.08||||||||1.08|0.55|
70978002|NCT03371355|141464195|SUPERIORITY||Least Squares Mean Difference|-23.2||||0.0916|TWO_SIDED|95.0|-50.17|3.83|||ANCOVA|||||3.83|-50.17|0.0916
70978003|NCT03371355|141464195|SUPERIORITY||Least Squares Mean Difference|-11.4||||0.4032|TWO_SIDED|95.0|-38.51|15.63|||ANCOVA|||||15.63|-38.51|0.4032
70978004|NCT03371355|141464195|SUPERIORITY||Least Squares Mean Difference|1.9||||0.8959|TWO_SIDED|95.0|-27.56|31.45|||ANCOVA|||||31.45|-27.56|0.8959
70978005|NCT03371355|141464196|SUPERIORITY||Least Squares Mean Difference|-0.052||||0.3202|TWO_SIDED|95.0|-0.16|0.05|||ANCOVA|||||0.05|-0.16|0.3202
70978006|NCT03371355|141464196|SUPERIORITY||Least Squares Mean Difference|-0.01||||0.8485|TWO_SIDED|95.0|-0.11|0.09|||ANCOVA|||||0.09|-0.11|0.8485
70978007|NCT03371355|141464196|SUPERIORITY||Least Squares Mean Difference|0.0314||||0.5812|TWO_SIDED|95.0|-0.08|0.14|||ANCOVA|||||0.14|-0.08|0.5812
70978008|NCT03371355|141464197|SUPERIORITY||Least Squares Mean Difference|0.43||||0.6157|TWO_SIDED|95.0|-1.28|2.15|||ANCOVA|||||2.15|-1.28|0.6157
70978009|NCT03371355|141464197|SUPERIORITY||Least Squares Mean Difference|0.01||||0.9869|TWO_SIDED|95.0|-1.66|1.69|||ANCOVA|||||1.69|-1.66|0.9869
70978010|NCT03371355|141464197|SUPERIORITY||Least Squares Mean Difference|-0.33||||0.7084|TWO_SIDED|95.0|-2.07|1.42|||ANCOVA|||||1.42|-2.07|0.7084
70978011|NCT03371355|141464198|SUPERIORITY||Least Squares Mean Difference|2.79||||0.4431|TWO_SIDED|95.0|-4.41|10.0|||ANCOVA|||SBP||10.00|-4.41|0.4431
70978012|NCT03371355|141464198|SUPERIORITY||Least Squares Mean Difference|2.08||||0.563|TWO_SIDED|95.0|-5.05|9.22|||ANCOVA|||SBP||9.22|-5.05|0.5630
70978013|NCT03371355|141464198|SUPERIORITY||Least Squares Mean Difference|-1.63||||0.6634|TWO_SIDED|95.0|-9.06|5.79|||ANCOVA|||SBP||5.79|-9.06|0.6634
70978014|NCT03371355|141464198|SUPERIORITY||Least Squares Mean Difference|4.11||||0.0937|TWO_SIDED|95.0|-0.71|8.92|||ANCOVA|||DBP||8.92|-0.71|0.0937
70978015|NCT03371355|141464198|SUPERIORITY||Least Squares Mean Difference|3.49||||0.1522|TWO_SIDED|95.0|-1.31|8.28|||ANCOVA|||DBP||8.28|-1.31|0.1522
70978016|NCT03371355|141464198|SUPERIORITY||Least Squares Mean Difference|1.62||||0.5188|TWO_SIDED|95.0|-3.35|6.59|||ANCOVA|||DBP||6.59|-3.35|0.5188
70978017|NCT03371355|141464199|SUPERIORITY||Least Squares Mean Difference|0.57||||0.5299|TWO_SIDED|95.0|-1.24|2.39|||ANCOVA|||Weight||2.39|-1.24|0.5299
70978018|NCT03371355|141464199|SUPERIORITY||Least Squares Mean Difference|-0.12||||0.8919|TWO_SIDED|95.0|-1.89|1.65|||ANCOVA|||Weight||1.65|-1.89|0.8919
70978019|NCT03371355|141464199|SUPERIORITY||Least Squares Mean Difference|-0.4||||0.6653|TWO_SIDED|95.0|-2.25|1.44|||ANCOVA|||Weight||1.44|-2.25|0.6653
70978020|NCT03371355|141464199|SUPERIORITY||Least Squares Mean Difference|2.35||||0.4213|TWO_SIDED|95.0|-3.43|8.14|||ANCOVA|||SBP||8.14|-3.43|0.4213
70978021|NCT03371355|141464199|SUPERIORITY||Least Squares Mean Difference|1.23||||0.6696|TWO_SIDED|95.0|-4.49|6.96|||ANCOVA|||SBP||6.96|-4.49|0.6696
71096109|NCT02070991|141700960|SUPERIORITY_OR_OTHER||Treatment effect (ratio of geom. means)|0.93|||||TWO_SIDED|95.0|0.64|1.36||||||||1.36|0.64|
71096110|NCT02070991|141700961|SUPERIORITY_OR_OTHER||Treatment effect (mean change from BL)|0.3|||||TWO_SIDED|95.0|-4.3|4.9||||||||4.9|-4.3|
71096111|NCT02070991|141700962|SUPERIORITY_OR_OTHER||Treatment effect (mean change from BL)|0.7|||||TWO_SIDED|95.0|-2.2|3.6||||||||3.6|-2.2|
70978022|NCT03371355|141464199|SUPERIORITY||Least Squares Mean Difference|-1.23||||0.6819|TWO_SIDED|95.0|-7.2|4.73|||ANCOVA|||SBP||4.73|-7.20|0.6819
71096112|NCT02070991|141700963|SUPERIORITY_OR_OTHER||Treatment effect (mean change from BL)|-0.3|||||TWO_SIDED|95.0|-4.2|3.7||||||||3.7|-4.2|
71096113|NCT02070991|141700964|SUPERIORITY_OR_OTHER||Treatment effect (mean change from BL)|0.4|||||TWO_SIDED|95.0|0.11|0.69||||||||0.69|0.11|
70922439|NCT01631214|141335816|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.64|STANDARD_ERROR_OF_MEAN|0.34||0.19|TWO_SIDED|95.0|0.33|1.26|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||1.26|0.33|0.19
70922440|NCT01631214|141335817|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.72|STANDARD_ERROR_OF_MEAN|0.17||0.053|TWO_SIDED|95.0|0.52|1.01|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||1.01|0.52|0.053
70922441|NCT01631214|141335818|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.56|STANDARD_ERROR_OF_MEAN|0.39||0.14|TWO_SIDED|95.0|0.26|1.22|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||1.22|0.26|0.14
70922442|NCT01631214|141335819|SUPERIORITY|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|8.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|7.58|8.57|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an analysis of covariance (ANCOVA) model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||8.57|7.58|<0.001
70922443|NCT01631214|141335820|SUPERIORITY|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|3.42|4.1|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||4.10|3.42|<0.001
70922444|NCT01631214|141335821|SUPERIORITY|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|3.4|4.14|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||4.14|3.40|<0.001
70922445|NCT01631214|141335822|SUPERIORITY|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|8.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|8.31|9.09|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||9.09|8.31|<0.001
70922446|NCT01631214|141335823|SUPERIORITY|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|3.03|3.6|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||3.60|3.03|<0.001
70922447|NCT01631214|141335824|SUPERIORITY|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|2.9|3.54|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||3.54|2.90|<0.001
70978023|NCT03371355|141464199|SUPERIORITY||Least Squares Mean Difference|5.01||||0.1171|TWO_SIDED|95.0|-1.28|11.31|||ANCOVA|||DBP||11.31|-1.28|0.1171
70978024|NCT03371355|141464199|SUPERIORITY||Least Squares Mean Difference|3.94||||0.2155|TWO_SIDED|95.0|-2.33|10.21|||ANCOVA|||DBP||10.21|-2.33|0.2155
71096114|NCT02070991|141700965|SUPERIORITY_OR_OTHER||Treatment effect (mean change from BL)|-0.4|||||TWO_SIDED|95.0|-4.5|3.6||||||||3.6|-4.5|
70978025|NCT03371355|141464199|SUPERIORITY||Least Squares Mean Difference|1.7||||0.6034|TWO_SIDED|95.0|-4.79|8.2|||ANCOVA|||DBP||8.20|-4.79|0.6034
70978026|NCT03371355|141464200|SUPERIORITY||Least Squares Mean Difference|0.98||||0.5752|TWO_SIDED|95.0|-2.48|4.44|||ANCOVA|||||4.44|-2.48|0.5752
70978027|NCT03371355|141464200|SUPERIORITY||Least Squares Mean Difference|4.09||||0.023|TWO_SIDED|95.0|0.58|7.59|||ANCOVA|||||7.59|0.58|0.0230
70978028|NCT03371355|141464200|SUPERIORITY||Least Squares Mean Difference|1.57||||0.3965|TWO_SIDED|95.0|-2.1|5.25|||ANCOVA|||||5.25|-2.10|0.3965
71034479|NCT00796653|141578375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.662|STANDARD_ERROR_OF_MEAN|0.308||0.0319||95.0|0.057|1.267|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.267|0.057|0.0319
71034480|NCT00796653|141578375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.667|STANDARD_ERROR_OF_MEAN|0.31||0.0312||95.0|0.06|1.274|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.274|0.060|0.0312
71096115|NCT00827242|141700966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.66||0.004||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IPSS. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.004
71096116|NCT00827242|141700967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.26||0.029||95.0||||The p-value associates with LS Mean difference of changes from baseline to 4 weeks between treatment groups for BII. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.029
71096117|NCT00827242|141700968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.057||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for BII. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.057
70978029|NCT03371355|141464201|SUPERIORITY||Least Squares Mean Difference|12.44||||0.3023|TWO_SIDED|95.0|-11.39|36.26|||ANCOVA|||||36.26|-11.39|0.3023
70978030|NCT03371355|141464201|SUPERIORITY||Least Squares Mean Difference|26.03||||0.035|TWO_SIDED|95.0|1.87|50.19|||ANCOVA|||||50.19|1.87|0.0350
70978031|NCT03371355|141464201|SUPERIORITY||Least Squares Mean Difference|12.27||||0.3374|TWO_SIDED|95.0|-13.02|37.55|||ANCOVA|||||37.55|-13.02|0.3374
70978032|NCT03371355|141464203|SUPERIORITY||Least Squares Mean Difference|-2.59||||0.4583|TWO_SIDED|95.0|-9.49|4.31|||ANCOVA|||||4.31|-9.49|0.4583
70978033|NCT03371355|141464203|SUPERIORITY||Least Squares Mean Difference|-5.71||||0.0943|TWO_SIDED|95.0|-12.43|1.0|||ANCOVA|||||1.00|-12.43|0.0943
71034481|NCT00796653|141578375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.419|STANDARD_ERROR_OF_MEAN|0.311||0.1777||95.0|-0.191|1.029|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.029|-0.191|0.1777
71034482|NCT00796653|141578376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.425|STANDARD_ERROR_OF_MEAN|0.311||0.1714||95.0|-0.184|1.035|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.035|-0.184|0.1714
70978034|NCT03371355|141464203|SUPERIORITY||Least Squares Mean Difference|-4.57||||0.1909|TWO_SIDED|95.0|-11.45|2.32|||ANCOVA|||||2.32|-11.45|0.1909
70978035|NCT03371355|141464204|SUPERIORITY||Least Squares Mean Difference|7.1||||0.1294|TWO_SIDED|95.0|-2.1|16.22|||ANCOVA|||ALT||16.22|-2.10|0.1294
70978036|NCT03371355|141464204|SUPERIORITY||Least Squares Mean Difference|14.8||||0.0012|TWO_SIDED|95.0|5.98|23.59|||ANCOVA|||ALT||23.59|5.98|0.0012
70978037|NCT03371355|141464204|SUPERIORITY||Least Squares Mean Difference|8.9||||0.0594|TWO_SIDED|95.0|-0.36|18.11|||ANCOVA|||ALT||18.11|-0.36|0.0594
70978038|NCT03371355|141464204|SUPERIORITY||[Least Squares Mean Difference|5.0||||0.073|TWO_SIDED|95.0|-0.47|10.45|||ANCOVA|||AST||10.45|-0.47|0.0730
70978039|NCT03371355|141464204|SUPERIORITY||Least Squares Mean Difference|8.4||||0.002|TWO_SIDED|95.0|3.17|13.7|||ANCOVA|||AST||13.70|3.17|0.0020
70978040|NCT03371355|141464204|SUPERIORITY||Least Squares Mean Difference|6.5||||0.02|TWO_SIDED|95.0|1.05|12.0|||ANCOVA|||AST||12.00|1.05|0.0200
70978041|NCT03371355|141464205|SUPERIORITY||Least Squares Mean Difference|-1.19||||0.4812|TWO_SIDED|95.0|-4.55|2.16|||ANCOVA|||||2.16|-4.55|0.4812
70978042|NCT03371355|141464205|SUPERIORITY||Least Squares Mean Difference|-1.53||||0.3679|TWO_SIDED|95.0|-4.88|1.83|||ANCOVA|||||1.83|-4.88|0.3679
70978043|NCT03371355|141464205|SUPERIORITY||Least Squares Mean Difference|-4.18||||0.021|TWO_SIDED|95.0|-7.72|-0.65|||ANCOVA|||||-0.65|-7.72|0.0210
70978044|NCT03371355|141464206|SUPERIORITY||Least Squares Mean Difference|-0.15||||0.6227|TWO_SIDED|95.0|-0.73|0.44|||ANCOVA|||||0.44|-0.73|0.6227
70978045|NCT03371355|141464206|SUPERIORITY||Least Squares Mean Difference|-0.38||||0.195|TWO_SIDED|95.0|-0.97|0.2|||ANCOVA|||||0.20|-0.97|0.1950
70978046|NCT03371355|141464206|SUPERIORITY||Least Squares Mean Difference|-0.38||||0.2271|TWO_SIDED|95.0|-1.0|0.24|||ANCOVA|||||0.24|-1.00|0.2271
70978047|NCT03371355|141464207|SUPERIORITY||Least Squares Mean Difference|17.06||||0.8591|TWO_SIDED|95.0|-173.57|207.69|||ANCOVA|||SAT||207.69|-173.57|0.8591
71096118|NCT00827242|141700969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.3||0.002||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IPSS storage subscore. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.002
71096119|NCT00827242|141700970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.43||0.02||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IPSS voiding subscore. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.020
71096120|NCT00827242|141700971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.233||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IPSS nocturia question. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.233
70978048|NCT03371355|141464207|SUPERIORITY||Least Squares Mean Difference|32.92||||0.7404|TWO_SIDED|95.0|-164.11|229.95|||ANCOVA|||SAT||229.95|-164.11|0.7404
70978049|NCT03371355|141464207|SUPERIORITY||Least Squares Mean Difference|-16.3||||0.8711|TWO_SIDED|95.0|-215.5|182.9|||ANCOVA|||SAT||182.90|-215.50|0.8711
70978050|NCT03371355|141464207|SUPERIORITY||Least Squares Mean Difference|4.95||||0.9569|TWO_SIDED|95.0|-176.64|186.53|||ANCOVA|||VAT||186.53|-176.64|0.9569
70978051|NCT03371355|141464207|SUPERIORITY||Least Squares Mean Difference|-24.26||||0.8025|TWO_SIDED|95.0|-216.53|168.02|||ANCOVA|||VAT||168.02|-216.53|0.8025
70978052|NCT03371355|141464207|SUPERIORITY||Least Squares Mean Difference|22.02||||0.8202|TWO_SIDED|95.0|-170.09|214.12|||ANCOVA|||VAT||214.12|-170.09|0.8202
70978053|NCT03371355|141464208|SUPERIORITY||Least Squares Mean Difference|0.11||||0.9734|TWO_SIDED|95.0|-6.47|6.69|||ANCOVA|||||6.69|-6.47|0.9734
70978054|NCT03371355|141464208|SUPERIORITY||Least Squares Mean Difference|-0.7||||0.8333|TWO_SIDED|95.0|-7.25|5.86|||ANCOVA|||||5.86|-7.25|0.8333
70978055|NCT03371355|141464208|SUPERIORITY||Least Squares Mean Difference|1.66||||0.6207|TWO_SIDED|95.0|-4.99|8.31|||ANCOVA|||||8.31|-4.99|0.6207
70978056|NCT03371355|141464209|SUPERIORITY||Least Squares Mean Difference|0.01||||0.8026|TWO_SIDED|95.0|-0.04|0.06|||ANCOVA|||||0.06|-0.04|0.8026
71034483|NCT00796653|141578376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.492|STANDARD_ERROR_OF_MEAN|0.312||0.1142||95.0|-0.119|1.103|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.103|-0.119|0.1142
70978057|NCT03371355|141464209|SUPERIORITY||Least Squares Mean Difference|-0.02||||0.4917|TWO_SIDED|95.0|-0.07|0.03|||ANCOVA|||||0.03|-0.07|0.4917
70978058|NCT03371355|141464209|SUPERIORITY||Least Squares Mean Difference|0.0||||0.8916|TWO_SIDED|95.0|-0.05|0.05|||ANCOVA|||||0.05|-0.05|0.8916
70978059|NCT03371355|141464210|SUPERIORITY||Least Squares Mean Difference|0.11||||0.728|TWO_SIDED|95.0|-0.5|0.71|||ANCOVA|||||0.71|-0.50|0.7280
70978060|NCT03371355|141464210|SUPERIORITY||Least Squares Mean Difference|-0.1||||0.7354|TWO_SIDED|95.0|-0.69|0.49|||ANCOVA|||||0.49|-0.69|0.7354
70978061|NCT03371355|141464210|SUPERIORITY||Least Squares Mean Difference|-0.23||||0.4682|TWO_SIDED|95.0|-0.84|0.39|||ANCOVA|||||0.39|-0.84|0.4682
70978062|NCT00977470|141464222|EQUIVALENCE|All enrolled patients will be included in the intent-to-treat efficacy analyses. Based on historical patients with EGFR mutations treated with gefitinib, we expect median progression-free survival on the erlotinib-alone arm to be approximately 9 months. This trial can detect a difference in proportions alive without progression at 9 months from 50% in the erlotinib arm to 77% in the erlotinib plus HCQ arm, using an alpha of 0.15 and power of 85%, using the two-sided Likelihood Ratio test.||||||0.28|||||||Log Rank|||||||0.28
71034484|NCT00796653|141578376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.534|STANDARD_ERROR_OF_MEAN|0.314||0.0888||95.0|-0.081|1.15|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.150|-0.081|0.0888
71034485|NCT00796653|141578377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.318||0.1235||95.0|-0.134|1.113|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.113|-0.134|0.1235
70978063|NCT00125034|141464229|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.516||||0.064|TWO_SIDED|95.0|0.975|2.335|||stratified Cochran-Mantel-Haenszel test|Stratified odds ratio and Cochran-Mantel-Haenszel (CMH) statistics were calculated considering the randomization strata.||Assuming a difference in rate of best confirmed response of at least 20% between the 2 treatments, ie an approximately 70% response rate under cetuximab plus FOLFOX-4 \& 50% under FOLFOX-4 alone for the stratum with ECOG PS0-1 \& 66% and 45% respectively for the ECOG PS2 stratum, the common OddsR over the strata was expected to be 2.33. A sample size of approximately 146/group was calculated as necessary to detect a significant overall response of at least 2.33 at level α=0.05 with a power of 90%||2.335|0.975|0.064
70978064|NCT00125034|141464230|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.551||||0.0027|TWO_SIDED|95.0|1.38|4.717|||stratified Cochran-Mantel-Haenszel test|Stratified odds ratio and Cochran-Mantel-Haenszel (CMH) statistics were calculated considering the randomization strata.||||4.717|1.380|0.0027
70978065|NCT00125034|141464231|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.459||||0.029|TWO_SIDED|95.0|0.228|0.924|||stratified Cochran-Mantel-Haenszel test|Stratified odds ratio and Cochran-Mantel-Haenszel (CMH) statistics were calculated considering the randomization strata.||||0.924|0.228|0.0290
70978066|NCT00125034|141464232|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.931||||0.617|TWO_SIDED|95.0|0.705|1.23|||Stratified Log Rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||1.230|0.705|0.6170
70978067|NCT00125034|141464233|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.567||||0.0064|TWO_SIDED|95.0|0.375|0.856|||Stratified Log Rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||0.856|0.375|0.0064
70978068|NCT00125034|141464234|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.72||||0.0153|TWO_SIDED|95.0|1.104|2.679|||Stratified Log Rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||2.679|1.104|0.0153
70978069|NCT00125034|141464235|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.015||||0.905|TWO_SIDED|95.0|0.791|1.303|||Stratified log rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||1.303|0.791|0.9050
70978070|NCT00125034|141464236|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.855||||0.3854|TWO_SIDED|95.0|0.599|1.219|||Stratified log rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||1.219|0.599|0.3854
70978071|NCT00125034|141464237|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.2004|TWO_SIDED|95.0|0.873|1.906|||Stratified log rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||1.906|0.873|0.2004
70978072|NCT03529409|141464250|SUPERIORITY||Mean Difference (Net)|-0.287||||0.01|TWO_SIDED|95.0|-0.507|-0.066|||Mixed Models Analysis|||||-.066|-.507|.01
71034486|NCT00796653|141578377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.354|STANDARD_ERROR_OF_MEAN|0.318||0.2666||95.0|-0.271|0.978|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.978|-0.271|0.2666
71034487|NCT00796653|141578377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.309|STANDARD_ERROR_OF_MEAN|0.319||0.3335||95.0|-0.317|0.934|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.934|-0.317|0.3335
71034488|NCT00796653|141578378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.313|STANDARD_ERROR_OF_MEAN|0.32||0.3287||95.0|-0.315|0.941|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.941|-0.315|0.3287
71034489|NCT00796653|141578378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.481|STANDARD_ERROR_OF_MEAN|0.321||0.1341||95.0|-0.148|1.109|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.109|-0.148|0.1341
70978073|NCT03529409|141464251|SUPERIORITY||Mean Difference (Net)|1.95||||0.28|TWO_SIDED|95.0|-1.61|5.5||The overall omnibus test of the time by treatment interaction was p=.55. The estimate below is for post-treatment, comparing TAU to Khanya.|Mixed Models Analysis|||||5.50|-1.61|.28
70978074|NCT03529409|141464252|SUPERIORITY||Mean Difference (Net)|157.0||||0.16|TWO_SIDED|95.0|-67.0|382.0||The overall omnibus test of the time by treatment interaction was p=.38. The estimate below is for post-treatment, comparing TAU to Khanya.|Mixed Models Analysis|||||382|-67|.16
70978075|NCT03529409|141464253|SUPERIORITY||Mean Difference (Net)|0.25||||0.77|TWO_SIDED|95.0|-1.51|2.0||The overall omnibus test of the time by treatment interaction was p=.90. The estimate below is for post-treatment, comparing TAU to Khanya.|Mixed Models Analysis|||||2.00|-1.51|.77
70978076|NCT03529409|141464254|SUPERIORITY||Mean Difference (Net)|0.71||||0.63|TWO_SIDED|95.0|-2.24|3.67||The overall omnibus test of the time by treatment interaction was p=.55. The estimate below is for follow-up, comparing TAU to Khanya.|Mixed Models Analysis|||||3.67|-2.24|.63
70978077|NCT03529409|141464255|SUPERIORITY||Mean Difference (Net)|84.0||||0.44|TWO_SIDED|95.0|-136.0|304.0||The overall omnibus test of the time by treatment interaction was p=.38. The estimate below is for follow-up, comparing TAU to Khanya.|Mixed Models Analysis|||||304|-136|.44
70978078|NCT03529409|141464256|SUPERIORITY||Mean Difference (Net)|-0.16||||0.87|TWO_SIDED|95.0|-1.85|1.58||The overall omnibus test of the time by treatment interaction was p=.90. The estimate below is for follow-up, comparing TAU to Khanya.|Mixed Models Analysis|||||1.58|-1.85|.87
70978079|NCT03529409|141464261|SUPERIORITY||Mean Difference (Net)|-0.47||||0.65|TWO_SIDED|95.0|-2.49|1.55||The overall omnibus test of the time by treatment interaction was p=.89. The estimate below is for follow-up, comparing TAU to Khanya.|Mixed Models Analysis|||||1.55|-2.49|.65
70978080|NCT03529409|141464262|SUPERIORITY||Mean Difference (Net)|3.3||||0.63|TWO_SIDED|95.0|-10.5|17.1||The overall omnibus test of the time by treatment interaction was p=.66. The estimate below is for follow-up, comparing TAU to Khanya.|Mixed Models Analysis|||||17.1|-10.5|.63
70978081|NCT03529409|141464263|SUPERIORITY||Mean Difference (Net)|-0.03||||0.85|TWO_SIDED|95.0|-0.34|0.28||The overall omnibus test of the time by treatment interaction was p=.94. The estimate below is for follow-up, comparing TAU to Khanya.|Mixed Models Analysis|||||.28|-.34|.85
70978082|NCT01813890|141464284|SUPERIORITY_OR_OTHER||Mean Difference (Net)|105.61||||0.006|TWO_SIDED|95.0|32.0|179.2||P-value adjusted for multiple treatment group comparisons using the Hochberg method.|ANCOVA|ANCOVA model with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID48 in tapentadol IR group minus SPID48 in placebo group|Based on participant availability in Taiwan it was expected that 60 subjects (20 per group) would be enrolled. In consultation with the Taiwan health authority, the overall two-sided significance level was set at 0.20 (0.10 for each tapentadol versus placebo comparison). Assuming a standard deviation of 134.4, this sample size would provide 71.5% power to detect a between-group difference in SPID48 of 94.1 and 81.2% power to detect a between-group difference of 107.52.||179.2|32.0|0.006
70978083|NCT01813890|141464284|SUPERIORITY_OR_OTHER||Median Difference (Net)|126.58||||0.004|TWO_SIDED|95.0|49.5|203.7||P-value adjusted for multiple treatment group comparisons using the Hochberg method.|ANCOVA|ANCOVA model with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID48 in tapentadol IR group minus SPID48 in placebo group.|Based on participant availability in Taiwan it was expected that 60 subjects (20 per group) would be enrolled. In consultation with the Taiwan health authority, the overall two-sided significance level was set at 0.20 (0.10 for each tapentadol versus placebo comparison). Assuming a standard deviation of 134.4, this sample size would provide 71.5% power to detect a between-group difference in SPID48 of 94.1 and 81.2% power to detect a between-group difference of 107.52.||203.7|49.5|0.004
70978084|NCT03952559|141464292|SUPERIORITY||Odds Ratio (OR)|1.13||||0.7261|TWO_SIDED|95.0|0.58|2.21|||Regression, Logistic|||||2.21|0.58|0.7261
70978085|NCT03952559|141464292|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0718|TWO_SIDED|95.0|0.95|3.41|||Regression, Logistic|||||3.41|0.95|0.0718
70978086|NCT03952559|141464292|SUPERIORITY||Odds Ratio (OR)|3.73|||<|0.0001|TWO_SIDED|95.0|2.02|6.89|||Regression, Logistic|||||6.89|2.02|<0.0001
70978087|NCT03952559|141464295|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9615|TWO_SIDED|95.0|0.59|1.74|||Regression, Logistic|||||1.74|0.59|0.9615
70978088|NCT03952559|141464295|SUPERIORITY||Odds Ratio (OR)|1.42||||0.201|TWO_SIDED|95.0|0.83|2.41|||Regression, Logistic|||||2.41|0.83|0.2010
70978089|NCT03952559|141464295|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0017|TWO_SIDED|95.0|1.38|3.95|||Regression, Logistic|||||3.95|1.38|0.0017
70978090|NCT03952559|141464296|SUPERIORITY||Odds Ratio (OR)|0.93||||0.8544|TWO_SIDED|95.0|0.43|2.01|||Regression, Logistic|||||2.01|0.43|0.8544
70978091|NCT03952559|141464296|SUPERIORITY||Odds Ratio (OR)|1.96||||0.0561|TWO_SIDED|95.0|0.98|3.91|||Regression, Logistic|||||3.91|0.98|0.0561
70978092|NCT03952559|141464296|SUPERIORITY||Odds Ratio (OR)|2.99||||0.0012|TWO_SIDED|95.0|1.54|5.82|||Regression, Logistic|||||5.82|1.54|0.0012
70978093|NCT03952559|141464297|SUPERIORITY||LS Mean difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|1.349||0.2627|TWO_SIDED|95.0|-4.16|1.14|||Mixed Models Analysis|||||1.14|-4.16|0.2627
71096121|NCT00827242|141700972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.013||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IPSS QoL Index. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.013
70978094|NCT03952559|141464297|SUPERIORITY||LS Mean difference (Final Values)|-1.67|STANDARD_ERROR_OF_MEAN|1.342||0.2135|TWO_SIDED|95.0|-4.31|0.97|||Mixed Models Analysis|||||0.97|-4.31|0.2135
70978095|NCT03952559|141464297|SUPERIORITY||LS Mean difference (Final Values)|-2.72|STANDARD_ERROR_OF_MEAN|1.347||0.0443|TWO_SIDED|95.0|-5.36|-0.07|||Mixed Models Analysis|||||-0.07|-5.36|0.0443
70978096|NCT03952559|141464298|SUPERIORITY||Odds Ratio (OR)|0.73||||0.4943|TWO_SIDED|95.0|0.3|1.78|||Regression, Logistic|||||1.78|0.30|0.4943
70978097|NCT03952559|141464298|SUPERIORITY||Odds Ratio (OR)|1.72||||0.1677|TWO_SIDED|95.0|0.8|3.7|||Regression, Logistic|||||3.70|0.80|0.1677
70978098|NCT03952559|141464298|SUPERIORITY||Odds Ratio (OR)|2.24||||0.0336|TWO_SIDED|95.0|1.06|4.7|||Regression, Logistic|||||4.70|1.06|0.0336
70978099|NCT03952559|141464299|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8866|TWO_SIDED|95.0|0.42|2.77|||Regression, Logistic|||||2.77|0.42|0.8866
70978100|NCT03952559|141464299|SUPERIORITY||Odds Ratio (OR)|1.73||||0.2316|TWO_SIDED|95.0|0.7|4.26|||Regression, Logistic|||||4.26|0.70|0.2316
70978101|NCT03952559|141464299|SUPERIORITY||Odds Ratio, log|2.59||||0.0328|TWO_SIDED|95.0|1.08|6.22|||Regression, Logistic|||||6.22|1.08|0.0328
70978102|NCT03952559|141464300|SUPERIORITY||Odds Ratio (OR)|1.18||||0.5361|TWO_SIDED|95.0|0.7|1.98|||Regression, Logistic|||||1.98|0.70|0.5361
70978103|NCT03952559|141464300|SUPERIORITY||Odds Ratio (OR)|1.23||||0.4417|TWO_SIDED|95.0|0.73|2.06|||Regression, Logistic|||||2.06|0.73|0.4417
70978104|NCT03952559|141464300|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0121|TWO_SIDED|95.0|1.16|3.43|||Regression, Logistic|||||3.43|1.16|0.0121
70978105|NCT03952559|141464301|SUPERIORITY||Odds Ratio (OR)|1.19||||0.7706|TWO_SIDED|95.0|0.37|3.78|||Regression, Logistic|||||3.78|0.37|0.7706
70978106|NCT03952559|141464301|SUPERIORITY||Odds Ratio (OR)|1.22||||0.7409|TWO_SIDED|95.0|0.38|3.86|||Regression, Logistic|||||3.86|0.38|0.7409
70978107|NCT03952559|141464301|SUPERIORITY||Odds Ratio (OR)|3.15||||0.0253|TWO_SIDED|95.0|1.15|8.63|||Regression, Logistic|||||8.63|1.15|0.0253
70978108|NCT03952559|141464302|SUPERIORITY||LS Mean difference (Final Values)|-3.89|STANDARD_ERROR_OF_MEAN|2.576||0.1317|TWO_SIDED|95.0|-8.95|1.17|||Mixed Models Analysis|||||1.17|-8.95|0.1317
70978109|NCT03952559|141464302|SUPERIORITY||LS Mean difference (Final Values)|-5.15|STANDARD_ERROR_OF_MEAN|2.564||0.0451|TWO_SIDED|95.0|-10.19|-0.11|||Mixed Models Analysis|||||-0.11|-10.19|0.0451
70978110|NCT03952559|141464302|SUPERIORITY||LS Mean difference (Final Values)|-7.62|STANDARD_ERROR_OF_MEAN|2.566||0.0031|TWO_SIDED|95.0|-12.66|-2.58|||Mixed Models Analysis|||||-2.58|-12.66|0.0031
70978111|NCT03952559|141464303|SUPERIORITY||Odds Ratio (OR)|0.53||||0.4238|TWO_SIDED|95.0|0.11|2.49|||Regression, Logistic|||||2.49|0.11|0.4238
70978112|NCT03952559|141464303|SUPERIORITY||Odds Ratio (OR)|1.5||||0.5118|TWO_SIDED|95.0|0.44|5.08|||Regression, Logistic|||||5.08|0.44|0.5118
70978113|NCT03952559|141464303|SUPERIORITY||Odds Ratio (OR)|3.92||||0.0129|TWO_SIDED|95.0|1.34|11.52|||Regression, Logistic|||||11.52|1.34|0.0129
70978114|NCT03952559|141464304|SUPERIORITY||LS Mean difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|2.168||0.4852|TWO_SIDED|95.0|-5.77|2.75|||Mixed Models Analysis|||||2.75|-5.77|0.4852
70978115|NCT03952559|141464304|SUPERIORITY||LS Mean difference (Final Values)|-1.74|STANDARD_ERROR_OF_MEAN|2.16||0.4205|TWO_SIDED|95.0|-5.98|2.5|||Mixed Models Analysis|||||2.50|-5.98|0.4205
70978116|NCT03952559|141464304|SUPERIORITY||LS Mean difference (Final Values)|-5.34|STANDARD_ERROR_OF_MEAN|2.161||0.0138|TWO_SIDED|95.0|-9.59|-1.1|||Mixed Models Analysis|||||-1.10|-9.59|0.0138
70978117|NCT03952559|141464305|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
70978118|NCT03952559|141464305|SUPERIORITY|||||||0.54|||||||Fisher Exact|||||||0.540
70978119|NCT03952559|141464305|SUPERIORITY|||||||0.302|||||||Fisher Exact|||||||0.302
70978120|NCT03952559|141464306|SUPERIORITY||LS Mean difference (Final Values)|4.47|STANDARD_ERROR_OF_MEAN|5.03||0.375|TWO_SIDED|95.0|-5.41|14.35|||ANOVA|||||14.35|-5.41|0.375
70978121|NCT03952559|141464306|SUPERIORITY||LS Mean difference (Final Values)|3.12|STANDARD_ERROR_OF_MEAN|5.03||0.536|TWO_SIDED|95.0|-6.76|13.0|||ANOVA|||||13.00|-6.76|0.536
70978122|NCT03952559|141464306|SUPERIORITY||LS Mean difference (Final Values)|12.17|STANDARD_ERROR_OF_MEAN|5.03||0.016|TWO_SIDED|95.0|2.29|22.05|||ANOVA|||||22.05|2.29|0.016
70978123|NCT03952559|141464307|SUPERIORITY||LS Mean difference (Final Values)|-49.19|STANDARD_ERROR_OF_MEAN|27.28||0.073|TWO_SIDED|95.0|-102.81|4.42|||ANOVA|||||4.42|-102.81|0.073
70978124|NCT03952559|141464307|SUPERIORITY||LS Mean difference (Final Values)|-37.38|STANDARD_ERROR_OF_MEAN|27.29||0.172|TWO_SIDED|95.0|-91.0|16.23|||ANOVA|||||16.23|-91.00|0.172
70978125|NCT03952559|141464307|SUPERIORITY||LS Mean difference (Final Values)|-80.37|STANDARD_ERROR_OF_MEAN|27.28||0.004|TWO_SIDED|95.0|-133.98|-26.75|||ANOVA|||||-26.75|-133.98|0.004
70978126|NCT03952559|141464308|SUPERIORITY||LS Mean difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.372||0.0829|TWO_SIDED|95.0|-1.38|0.08|||Mixed Models Analysis|||||0.08|-1.38|0.0829
70978127|NCT03952559|141464308|SUPERIORITY||LS Mean difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.368||0.1752|TWO_SIDED|95.0|-1.22|0.22|||Mixed Models Analysis|||||0.22|-1.22|0.1752
70978128|NCT03952559|141464308|SUPERIORITY||LS Mean difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.366||0.0029|TWO_SIDED|95.0|-1.82|-0.38|||Mixed Models Analysis|||||-0.38|-1.82|0.0029
70978129|NCT03952559|141464309|SUPERIORITY||LS Mean difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.193||0.2688|TWO_SIDED|95.0|-0.6|0.17|||Mixed Models Analysis|||||0.17|-0.60|0.2688
70978130|NCT03952559|141464309|SUPERIORITY||LS Mean difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.193||0.0166|TWO_SIDED|95.0|-0.85|-0.09|||Mixed Models Analysis|||||-0.09|-0.85|0.0166
70978131|NCT03952559|141464309|SUPERIORITY||LS Mean difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.202||0.0908|TWO_SIDED|95.0|-0.75|0.06|||Mixed Models Analysis|||||0.06|-0.75|0.0908
70978132|NCT03952559|141464310|SUPERIORITY||LS Mean difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.956||0.3409|TWO_SIDED|95.0|-2.79|0.97|||Mixed Models Analysis|||||0.97|-2.79|0.3409
70978133|NCT03952559|141464310|SUPERIORITY||LS Mean difference (Final Values)|-1.56|STANDARD_ERROR_OF_MEAN|0.952||0.1022|TWO_SIDED|95.0|-3.43|0.31|||Mixed Models Analysis|||||0.31|-3.43|0.1022
70978134|NCT03952559|141464310|SUPERIORITY||LS Mean difference (Final Values)|-1.56|STANDARD_ERROR_OF_MEAN|0.953||0.1024|TWO_SIDED|95.0|-3.43|0.31|||Mixed Models Analysis|||||0.31|-3.43|0.1024
70978135|NCT03952559|141464311|SUPERIORITY||LS Mean difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.157||0.1436|TWO_SIDED|95.0|-0.54|0.08|||Mixed Models Analysis|||||0.08|-0.54|0.1436
70978136|NCT03952559|141464311|SUPERIORITY||LS Mean difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.154||0.0483|TWO_SIDED|95.0|-0.61|0.0|||Mixed Models Analysis|||||-0.00|-0.61|0.0483
70978137|NCT03952559|141464311|SUPERIORITY||LS Mean difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.154||0.0012|TWO_SIDED|95.0|-0.8|-0.2|||Mixed Models Analysis|||||-0.20|-0.80|0.0012
70978138|NCT03952559|141464312|SUPERIORITY||LS Mean difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|1.755||0.9183|TWO_SIDED|95.0|-3.27|3.63|||Mixed Models Analysis|||for 8 to \<18 years old||3.63|-3.27|0.9183
70978139|NCT03952559|141464312|SUPERIORITY||LS Mean difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|1.529||0.4805|TWO_SIDED|95.0|-4.09|1.93|||Mixed Models Analysis|||for 8 to \<18 years old||1.93|-4.09|0.4805
70978140|NCT03952559|141464312|SUPERIORITY||LS Mean difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|1.812||0.3488|TWO_SIDED|95.0|-5.26|1.86|||Mixed Models Analysis|||for 8 to \<18 years old||1.86|-5.26|0.3488
70978141|NCT03952559|141464312|SUPERIORITY||LS Mean difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|3.12||0.2388|TWO_SIDED|95.0|-4.85|7.66|||Mixed Models Analysis|||for 5 to \<8 years old||7.66|-4.85|0.2388
70978142|NCT03952559|141464312|SUPERIORITY||LS Mean difference (Final Values)|-3.13|STANDARD_ERROR_OF_MEAN|3.542||0.0098|TWO_SIDED|95.0|-10.23|3.98|||Mixed Models Analysis|||for 5 to \<8 years old||3.98|-10.23|0.0098
70978143|NCT03952559|141464312|SUPERIORITY||LS Mean difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|3.14||0.1698|TWO_SIDED|95.0|-5.18|7.42|||Mixed Models Analysis|||for 5 to \<8 years old||7.42|-5.18|0.1698
70978144|NCT03952559|141464313|SUPERIORITY||LS Mean difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|1.813||0.8611|TWO_SIDED|95.0|-3.24|3.88|||Mixed Models Analysis|||for 8 to \<18 years old||3.88|-3.24|0.8611
70978145|NCT03952559|141464313|SUPERIORITY||LS Mean difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|1.571||0.5098|TWO_SIDED|95.0|-4.12|2.05|||Mixed Models Analysis|||for 8 to \<18 years old||2.05|-4.12|0.5098
70978146|NCT03952559|141464313|SUPERIORITY||LS Mean difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|1.87||0.1997|TWO_SIDED|95.0|-6.08|1.27|||Mixed Models Analysis|||for 8 to \<18 years old||1.27|-6.08|0.1997
70978147|NCT03952559|141464313|SUPERIORITY||LS Mean difference (Final Values)|1.62|STANDARD_ERROR_OF_MEAN|3.351||0.1957|TWO_SIDED|95.0|-5.11|8.35|||Mixed Models Analysis|||for 5 to \<8 years old||8.35|-5.11|0.1957
70978148|NCT03952559|141464313|SUPERIORITY||LS Mean difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|3.864||0.0881|TWO_SIDED|95.0|-8.19|7.32|||Mixed Models Analysis|||for 5 to \<8 years old||7.32|-8.19|0.0881
70978149|NCT03952559|141464313|SUPERIORITY||LS Mean difference (Final Values)|1.51|STANDARD_ERROR_OF_MEAN|3.379||0.1604|TWO_SIDED|95.0|-5.27|8.28|||Mixed Models Analysis|||for 5 to \<8 years old||8.28|-5.27|0.1604
70978150|NCT03952559|141464314|SUPERIORITY||LS Mean difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.647||0.2987|TWO_SIDED|95.0|-1.93|0.59|||Mixed Models Analysis|||||0.59|-1.93|0.2987
70978151|NCT03952559|141464314|SUPERIORITY||LS Mean difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.632||0.3096|TWO_SIDED|95.0|-1.88|0.6|||Mixed Models Analysis|||||0.60|-1.88|0.3096
70978152|NCT03952559|141464314|SUPERIORITY||LS Mean difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.635||0.6341|TWO_SIDED|95.0|-1.55|0.95|||Mixed Models Analysis|||||0.95|-1.55|0.6341
71096122|NCT00827242|141700973|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||The p-value associates with difference between treatment groups for the 7 response categories.|Cochran-Mantel-Haenszel|Results were adjusted for baseline LUTS severity (moderate \[total IPSS \< 20\]; severe \[total IPSS \>= 20\]||||||0.021
70978153|NCT03952559|141464315|SUPERIORITY||LS Mean difference (Final Values)|5.27|STANDARD_ERROR_OF_MEAN|4.323||0.2871|TWO_SIDED|95.0|-6.54|17.09|||Mixed Models Analysis|||||17.09|-6.54|0.2871
70978154|NCT03952559|141464315|SUPERIORITY||LS Mean difference (Final Values)|4.73|STANDARD_ERROR_OF_MEAN|3.835||0.3093|TWO_SIDED|95.0|-7.83|17.29|||Mixed Models Analysis|||||17.29|-7.83|0.3093
70978155|NCT03952559|141464315|SUPERIORITY||LS Mean difference (Final Values)|-5.0|STANDARD_ERROR_OF_MEAN|3.788||0.2912|TWO_SIDED|95.0|-18.22|8.21|||Mixed Models Analysis|||||8.21|-18.22|0.2912
70978156|NCT03952559|141464316|SUPERIORITY|Absenteeism Change from Baseline|LS Mean difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|3.119||0.6079|TWO_SIDED|95.0|-7.74|4.54|||Mixed Models Analysis|||||4.54|-7.74|0.6079
70978157|NCT03952559|141464316|SUPERIORITY||LS Mean difference (Final Values)|-1.85|STANDARD_ERROR_OF_MEAN|3.092||0.5492|TWO_SIDED|95.0|-7.94|4.24|||Mixed Models Analysis|||Absenteeism Change from Baseline||4.24|-7.94|0.5492
70978158|NCT03952559|141464316|SUPERIORITY||LS Mean difference (Final Values)|-4.93|STANDARD_ERROR_OF_MEAN|3.281||0.1338|TWO_SIDED|95.0|-11.39|1.53|||Mixed Models Analysis|||Absenteeism Change from Baseline||1.53|-11.39|0.1338
70978159|NCT03952559|141464316|SUPERIORITY||LS Mean difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|3.566||0.7928|TWO_SIDED|95.0|-7.96|6.08|||Mixed Models Analysis|||Presenteeism Change from Baseline||6.08|-7.96|0.7928
70978160|NCT03952559|141464316|SUPERIORITY||LS Mean difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|3.553||0.1366|TWO_SIDED|95.0|-12.3|1.69|||Mixed Models Analysis|||Presenteeism Change from Baseline||1.69|-12.30|0.1366
70978161|NCT03952559|141464316|SUPERIORITY||LS Mean difference (Final Values)|-6.75|STANDARD_ERROR_OF_MEAN|3.792||0.076|TWO_SIDED|95.0|-14.21|0.71|||Mixed Models Analysis|||Presenteeism Change from Baseline||0.71|-14.21|0.0760
70978162|NCT03952559|141464316|SUPERIORITY||LS Mean difference (Final Values)|-4.18|STANDARD_ERROR_OF_MEAN|4.561||0.3602|TWO_SIDED|95.0|-13.16|4.8|||Mixed Models Analysis|||Overall Work Impairment Change from Baseline||4.80|-13.16|0.3602
70978163|NCT03952559|141464316|SUPERIORITY||LS Mean difference (Final Values)|-6.25|STANDARD_ERROR_OF_MEAN|4.516||0.1678|TWO_SIDED|95.0|-15.14|2.65|||Mixed Models Analysis|||Overall Work Impairment Change from Baseline||2.65|-15.14|0.1678
71034490|NCT00796653|141578378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.322||0.722||95.0|-0.516|0.745|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.745|-0.516|0.7220
71096123|NCT00827242|141700974|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||The p-value associates with difference between treatment groups for the 7 response categories.|Cochran-Mantel-Haenszel|Results were adjusted for baseline LUTS severity (moderate \[total IPSS \< 20\]; severe \[total IPSS \>= 20\]||||||0.009
70978164|NCT03952559|141464316|SUPERIORITY||LS Mean difference (Final Values)|-11.54|STANDARD_ERROR_OF_MEAN|4.808||0.017|TWO_SIDED|95.0|-21.0|-2.08|||Mixed Models Analysis|||Overall Work Impairment Change from Baseline||-2.08|-21.00|0.0170
70978165|NCT03952559|141464316|SUPERIORITY||LS Mean difference (Final Values)|-4.42|STANDARD_ERROR_OF_MEAN|3.174||0.1645|TWO_SIDED|95.0|-10.66|1.82|||Mixed Models Analysis|||Activity Impairment Change from Baseline||1.82|-10.66|0.1645
70978166|NCT03952559|141464316|SUPERIORITY||LS Mean difference (Final Values)|-4.87|STANDARD_ERROR_OF_MEAN|3.158||0.124|TWO_SIDED|95.0|-11.07|1.34|||Mixed Models Analysis|||Activity Impairment Change from Baseline||1.34|-11.07|0.1240
71034491|NCT00796653|141578379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.397|STANDARD_ERROR_OF_MEAN|0.322||0.2176||95.0|-0.234|1.027|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.027|-0.234|0.2176
70978167|NCT03952559|141464316|SUPERIORITY||LS Mean difference (Final Values)|-7.02|STANDARD_ERROR_OF_MEAN|3.163||0.027|TWO_SIDED|95.0|-13.23|-0.8|||Mixed Models Analysis|||Activity Impairment Change from Baseline||-0.80|-13.23|0.0270
70978168|NCT03952559|141464317|SUPERIORITY||LS Mean difference (Final Values)|1.97|STANDARD_ERROR_OF_MEAN|2.778||0.4778|TWO_SIDED|95.0|-3.49|7.43|||Mixed Models Analysis|||||7.43|-3.49|0.4778
70978169|NCT03952559|141464317|SUPERIORITY||LS Mean difference (Final Values)|2.01|STANDARD_ERROR_OF_MEAN|2.743||0.4649|TWO_SIDED|95.0|-3.38|7.39|||Mixed Models Analysis|||||7.39|-3.38|0.4649
70978170|NCT03952559|141464317|SUPERIORITY||LS Mean difference (Final Values)|4.52|STANDARD_ERROR_OF_MEAN|2.755||0.1013|TWO_SIDED|95.0|-0.89|9.94|||Mixed Models Analysis|||||9.94|-0.89|0.1013
70978171|NCT03952559|141464318|SUPERIORITY||LS Mean difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.174||0.6574|TWO_SIDED|95.0|-0.27|0.42|||Mixed Models Analysis|||||0.42|-0.27|0.6574
70978172|NCT03952559|141464318|SUPERIORITY||LS Mean difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.172||0.9488|TWO_SIDED|95.0|-0.35|0.33|||Mixed Models Analysis|||||0.33|-0.35|0.9488
70978173|NCT03952559|141464318|SUPERIORITY||LS Mean difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.172||0.4546|TWO_SIDED|95.0|-0.47|0.21|||Mixed Models Analysis|||||0.21|-0.47|0.4546
70978174|NCT03952559|141464319|SUPERIORITY||LS Mean difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.36||0.8133|TWO_SIDED|95.0|-0.79|0.62|||Mixed Models Analysis|||||0.62|-0.79|0.8133
70978175|NCT03952559|141464319|SUPERIORITY||LS Mean difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.355||0.2517|TWO_SIDED|95.0|-1.11|0.29|||Mixed Models Analysis|||||0.29|-1.11|0.2517
70978176|NCT03952559|141464319|SUPERIORITY||LS Mean difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.354||0.0803|TWO_SIDED|95.0|-1.32|0.08|||Mixed Models Analysis|||||0.08|-1.32|0.0803
70978177|NCT01870739|141464327|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.0616||||0.7324|TWO_SIDED|95.0|-0.4178|0.2947|||Linear Model|Treatment as fixed effect and corresponding baseline as covariate.||||0.2947|-0.4178|0.7324
70978178|NCT01870739|141464328|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.0371||||0.8614|TWO_SIDED|95.0|-0.4582|0.3839|||Linear Model|Treatment as a fixed effect and corresponding baseline as a covariate||||0.3839|-0.4582|0.8614
70978179|NCT01870739|141464329|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.0812||||0.7946|TWO_SIDED|95.0|-0.6987|0.5362|||Linear Model|Treatment as a fixed effect and corresponding baseline as a covariate||||0.5362|-0.6987|0.7946
70978180|NCT01986062|141464337|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
71034492|NCT00796653|141578379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.718|STANDARD_ERROR_OF_MEAN|0.323||0.0258||95.0|0.087|1.348|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.348|0.087|0.0258
71034493|NCT00796653|141578379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|STANDARD_ERROR_OF_MEAN|0.323||0.6044||95.0|-0.466|0.8|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.800|-0.466|0.6044
71034494|NCT00796653|141578380|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.802|STANDARD_ERROR_OF_MEAN|0.133||0.1946||95.0|0.58|1.111|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.111|0.580|0.1946
71034495|NCT00796653|141578380|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.872|STANDARD_ERROR_OF_MEAN|0.141||0.4071||95.0|0.634|1.198|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.198|0.634|0.4071
71034496|NCT00796653|141578380|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.922|STANDARD_ERROR_OF_MEAN|0.15||0.6404||95.0|0.67|1.267|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum|||1.267|0.670|0.6404
71034497|NCT00796653|141578381|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.685|STANDARD_ERROR_OF_MEAN|0.249||0.2942||95.0|0.336|1.399|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.399|0.336|0.2942
71034498|NCT00796653|141578381|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.947|STANDARD_ERROR_OF_MEAN|0.316||0.8594||95.0|0.493|1.82|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.820|0.493|0.8594
71034499|NCT00796653|141578381|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.803|STANDARD_ERROR_OF_MEAN|0.281||0.5466||95.0|0.405|1.593|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum|||1.593|0.405|0.5466
70978181|NCT01986062|141464338|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
70978182|NCT01986062|141464339|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
70978183|NCT01986062|141464340|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
70978184|NCT01986062|141464341|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
70978185|NCT01986062|141464342|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
70978186|NCT00288574|141464364|SUPERIORITY|||||||0.57|||||||Chi-squared|||The proportion of patients successfully completing the trial in the fluoxetine and placebo groups was compared using the chi-squared statistic.||||0.57
70978187|NCT00288574|141464365|SUPERIORITY|||||||0.75||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in body weight, in fluoxetine vs placebo groups.||||0.75
70978188|NCT00288574|141464366|SUPERIORITY|||||||0.007||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment of BDI in fluoxetine versus placebo groups||||0.007
70978189|NCT00288574|141464367|SUPERIORITY|||||||0.79||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in BDI, in fluoxetine vs placebo groups.||||0.79
70978190|NCT00288574|141464368|SUPERIORITY|||||||0.69||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in RSES, in fluoxetine vs placebo groups.||||0.69
70978191|NCT00288574|141464369|SUPERIORITY|||||||0.78||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in Q-LES-Q, in fluoxetine vs placebo groups.||||0.78
70978192|NCT00288574|141464370|SUPERIORITY|||||||0.19||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in Drive for Thinness subscale, in fluoxetine vs placebo groups.||||0.19
70978193|NCT00288574|141464371|SUPERIORITY|||||||0.46||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in Bulimia subscale, in fluoxetine vs placebo groups.||||0.46
70978194|NCT00288574|141464372|SUPERIORITY|||||||0.86||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment on Body Dissatisfaction subscale, in fluoxetine vs placebo groups.||||0.86
70978195|NCT00288574|141464373|SUPERIORITY|||||||0.25||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment on Perfectionism subscale, in fluoxetine vs placebo groups.||||0.25
70978196|NCT00288574|141464374|SUPERIORITY|||||||0.26|||||||Mixed Models Analysis|Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.||Random effects regression analysis of change during treatment on the YBC-EDS, in fluoxetine vs placebo groups.||||0.26
70978197|NCT04596891|141464402|OTHER|Repeated measures ANOVA|F ratio|20.62|||<|0.001|TWO_SIDED|95.0|||||ANOVA||The F ratio is used to evaluate the main effect of time in the ANOVA in relation to the critical F ratio.|No control group, open trial for feasibility/safety||||<0.001
70978198|NCT04596891|141464402|OTHER|Paired-samples t-test (baseline to post-treatment)|paired-samples t-test|5.2||||0.002|TWO_SIDED|95.0|-1.79|12.93|||t-test, 2 sided|||||12.93|-1.79|0.002
70978199|NCT04596891|141464407|OTHER|ANOVA|F ratio|8.46|||<|0.001|TWO_SIDED|95.0|||||ANOVA||The F ratio is used to evaluate the main effect of time in the ANOVA in relation to the critical F ratio. If it exceeds the critical F ratio, the null hypothesis (no effect of time) is rejected.|||||<0.001
70978200|NCT03219164|141464434|NON_INFERIORITY|Non-inferiority of the 14-day treatment regimen was claimed if the lower bound of 1-sided 97.5% confidence limit of the treatment difference (14-day course group vs 28-day course group) was above the noninferiority margin of -20%.|Difference in percentage|-8.0|||||TWO_SIDED|95.0|-24.6|8.6|||||The difference in percentage between treatment groups, and the associated 95% CIs were constructed based on stratum-adjusted Mantel-Haenszel method using age as stratification factor.|||8.6|-24.6|
70978201|NCT03219164|141464436|OTHER||||||||||||||||||The historical pooled data from published results for the percentage of participants with successful PA eradication at 28 days post-treatment with TNS was estimated to be 77%.|||
70978202|NCT02689492|141464440|OTHER||Intercept|68.5027|STANDARD_DEVIATION|8.0355|||||||||||Standard deviation is actually standard error.|||||
70978203|NCT02689492|141464441|OTHER||Intercept|95.4051|STANDARD_DEVIATION|6.9951|||||||||||Standard deviation is actually standard error.|||||
70978204|NCT02689492|141464442|OTHER||Intercept|74.8895|STANDARD_DEVIATION|8.0048|||||||||||Standard deviation is actually standard error.|||||
70978205|NCT04025632|141464449|SUPERIORITY||Wilcoxon-Mann-Whitney odds|0.55||||0.464|TWO_SIDED|95.0|0.19|1.57||Conducted using a 2-sided Van Elteren test, which represents an extension of the Wilcoxon rank sum test for comparing 2 treatments in a stratified experiment using within-stratum ranks assigning greater weight to rank sums from smaller strata.|2-sided Van Elteren test||The magnitude of association between treatment groups was expressed as in Wilcoxon-Mann-Whitney odds followed by the 95% confidence intervals.|||1.57|0.19|0.464
70978206|NCT04025632|141464451|SUPERIORITY||Odds Ratio (OR)|1.088||||0.919|TWO_SIDED|95.0|0.214|5.535||P-value for the comparison of treatment groups was calculated using logistic regression with investigational medicinal product and strata as fixed factors.|Regression, Logistic|||||5.535|0.214|0.919
71034500|NCT00796653|141578382|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.807|STANDARD_ERROR_OF_MEAN|0.146||0.2494||95.0|0.566|1.15|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.150|0.566|0.2494
71034501|NCT00796653|141578382|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.791|STANDARD_ERROR_OF_MEAN|0.143||0.2006||95.0|0.555|1.126|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.126|0.555|0.2006
71034502|NCT00796653|141578382|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.903|STANDARD_ERROR_OF_MEAN|0.16||0.5795||95.0|0.637|1.279|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum|||1.279|0.637|0.5795
71034503|NCT00796653|141578383|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.785|STANDARD_ERROR_OF_MEAN|0.1342||0.1571||95.0|0.5613|1.0979|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.0979|0.5613|0.1571
71034504|NCT00796653|141578383|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.8631|STANDARD_ERROR_OF_MEAN|0.1451||0.3814||95.0|0.6205|1.2005|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.2005|0.6205|0.3814
71034505|NCT00796653|141578383|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.0631|STANDARD_ERROR_OF_MEAN|0.1748||0.7098||95.0|0.7699|1.468|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo|||1.4680|0.7699|0.7098
71034506|NCT00796653|141578384|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.7925|STANDARD_ERROR_OF_MEAN|0.2952||0.5326||95.0|0.3814|1.6464|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.6464|0.3814|0.5326
71034507|NCT00796653|141578384|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.0078|STANDARD_ERROR_OF_MEAN|0.356||0.9824||95.0|0.5038|2.016|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||2.0160|0.5038|0.9824
71096124|NCT00827242|141700975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.49||0.146||95.0||||The p-value associates with LS Mean difference of changes from baseline to 1 week between treatment groups for IPSS. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.146
70978207|NCT04025632|141464452|SUPERIORITY||Least squares (LS) mean difference|-0.688||||0.496|TWO_SIDED|95.0|-2.781|1.404||Based on a linear model with treatment and strata (anti-3-hydroxy-3-methyl-glutaryl-coenzyme A reductase \[HMGCR\]+/anti-signal recognition particle \[SRP\]+) as fixed factors with Baseline 3TUG as a covariate.|Linear Mixed Effect Model||The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||1.404|-2.781|0.496
70978208|NCT04025632|141464453|SUPERIORITY||LS mean difference|3.89||||0.431|TWO_SIDED|95.0|-6.18|13.95||Based on a linear model with treatment and strata (anti-HMGCR+/anti-SRP+) as fixed factors with Baseline proximal MMT as a covariate.|Linear Mixed Effect Model||The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||13.95|-6.18|0.431
70978209|NCT04025632|141464454|SUPERIORITY||LS mean difference|-0.204||||0.8|TWO_SIDED|95.0|-1.855|1.448||Based on a linear model with treatment and strata (anti-HMGCR+/anti-SRP+) as fixed factors with Baseline Physician Global Activity VAS as a covariate.|Linear Mixed Effect Model||The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||1.448|-1.855|0.800
70978210|NCT04025632|141464455|SUPERIORITY||LS mean difference|-1.281||||0.221|TWO_SIDED|95.0|-3.39|0.829||Based on a linear model with treatment and strata (anti-HMGCR+/anti-SRP+) as fixed factors with Baseline Patient Global Activity VAS as a covariate.|Linear Mixed Effect Model||The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||0.829|-3.390|0.221
70978211|NCT04025632|141464456|SUPERIORITY||LS mean difference|-0.147||||0.508|TWO_SIDED|95.0|-0.601|0.307||Based on a linear model with treatment and strata (anti-HMGCR+/anti-SRP+) as fixed factors with Baseline HAQ as a covariate.|Linear Mixed Effect Model||The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||0.307|-0.601|0.508
70978212|NCT04025632|141464457|SUPERIORITY||LS mean difference|-0.143||||0.765|TWO_SIDED|95.0|-1.123|0.837|||Linear Mixed Effect Model|Based on a linear model with treatment and strata (anti-HMGCR+/anti-SRP+) as fixed factors with Baseline MDAAT as a covariate.|The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||0.837|-1.123|0.765
70978213|NCT04025632|141464458|SUPERIORITY||LS mean difference|5.53||||0.265|TWO_SIDED|95.0|-4.49|15.55||Based on a linear model with treatment and strata (anti-HMGCR+/anti-SRP+) as fixed factors with Baseline FACIT-Fatigue Scale as a covariate.|Linear Mixed Effect Model||The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||15.55|-4.49|0.265
70978214|NCT02274688|141464474|SUPERIORITY||||||=|0.01|||||||Wald Chi-Square=11.29, df=3, P=0.01|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.01
70978215|NCT02274688|141464475|SUPERIORITY||||||=|0.23|||||||Wald Chi-Square=3.01, df=3, p=0.23|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.23
70978216|NCT02274688|141464476|SUPERIORITY||||||=|0.23|||||||Wald Chi-Square=4.25, df=3, p=0.23|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.23
71096125|NCT00827242|141700976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.6||0.003||95.0||||The p-value associates with LS Mean difference of changes from baseline to 4 weeks between treatment groups for IPSS. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.003
70978217|NCT02274688|141464477|SUPERIORITY||||||=|0.55|||||||Wald Chi-Square=2.12, df=3, p=0.55|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.55
70978218|NCT02274688|141464478|SUPERIORITY||||||=|0.32|||||||Wald Chi-Square=3.52, df=3; p=0.32|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.32
70978219|NCT02274688|141464479|SUPERIORITY||||||=|0.26|||||||Wald Chi-Square=4.02, df=3, p=0.26|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.26
70978220|NCT02274688|141464480|SUPERIORITY||||||=|0.22|||||||Wald Chi-Square=4.44, df=3, p=0.22|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.22
70978221|NCT02274688|141464481|SUPERIORITY||||||=|0.08||||||F(3,507)=2.24, P=0.08|Regression Poisson|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.08
70978222|NCT02274688|141464482|SUPERIORITY|||||||0.36|||||||Wald Chi-Square=3.24, df=3, p=0.36|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||0.36
71034508|NCT00796653|141578384|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.0403|STANDARD_ERROR_OF_MEAN|0.3681||0.9112||95.0|0.5194|2.0832|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo|||2.0832|0.5194|0.9112
71034509|NCT00796653|141578385|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.744|STANDARD_ERROR_OF_MEAN|0.1389||0.1136||95.0|0.5158|1.0733|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.0733|0.5158|0.1136
71034510|NCT00796653|141578385|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.7842|STANDARD_ERROR_OF_MEAN|0.1449||0.1887||95.0|0.5456|1.1271|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.1271|0.5456|0.1887
70978223|NCT00951821|141464487|SUPERIORITY_OR_OTHER||Slope|-3.3||||0.46|TWO_SIDED|95.0|-12.1|5.5||Effect sizes were also calculated due to small sample size|Mixed Models Analysis||The reported statistic (-3.3) is the difference in the change from baseline to follow-up between the two treatment arms, estimated in a mixed effect regression model.|||5.5|-12.1|.46
71034511|NCT00796653|141578385|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.9761|STANDARD_ERROR_OF_MEAN|0.1747||0.8925||95.0|0.6869|1.387|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo|||1.3870|0.6869|0.8925
70978224|NCT00951821|141464488|SUPERIORITY_OR_OTHER||Slope|0.4||||0.75|TWO_SIDED|95.0|-2.36|3.06|||Mixed Models Analysis||The statistic provided (0.4) is the difference in the change in BDI score from baseline to follow-up by treatment group.|||3.06|-2.36|.75
70978225|NCT00391599|141464500|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Chi-squared|||||||0.15
70978226|NCT00391599|141464502|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
71034512|NCT00796653|141578388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.509|STANDARD_ERROR_OF_MEAN|0.23||0.027|TWO_SIDED|95.0|0.058|0.96|||pattern mixture model|See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455-1497(2004)|"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1\) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Olo 5mcg minus placebo||0.960|0.058|0.0270
71034513|NCT00796653|141578388|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.525|STANDARD_ERROR_OF_MEAN|0.226||0.0203|TWO_SIDED|95.0|0.082|0.967|||pattern mixture model|See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455-1497(2004)|"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1\) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Olo 10 mcg minus placebo||0.967|0.082|0.0203
71034514|NCT00796653|141578388|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.355|STANDARD_ERROR_OF_MEAN|0.226||0.1166|TWO_SIDED|95.0|-0.088|0.799|||pattern mixture model|See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455-1497(2004)|"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1\) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Form 12mcg minus placebo||0.799|-0.088|0.1166
71034515|NCT03393208|141578389|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LeastSquare(LS) Mean%|99.76|||||TWO_SIDED|90.0|92.84|107.2||||||Statistical Comparison of Treatment A Versus Treatment B in Fasting state||107.20|92.84|
70978227|NCT03124459|141464520|SUPERIORITY||Mean Difference (Final Values)|13.5|STANDARD_ERROR_OF_MEAN|5.2||0.01|TWO_SIDED|90.0|4.9|22.1|||ANCOVA|||||22.1|4.9|0.01
70978228|NCT03124459|141464521|SUPERIORITY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|2.2||0.16|TWO_SIDED|90.0|-6.8|0.6|||ANCOVA|||||0.6|-6.8|0.16
70978229|NCT03124459|141464522|SUPERIORITY||Mean Difference (Final Values)|35.4|STANDARD_ERROR_OF_MEAN|23.5||0.13|TWO_SIDED|90.0|-3.2|74.0|||ANCOVA|||||74|-3.2|0.13
70978230|NCT03124459|141464523|SUPERIORITY||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|5.5||0.73|TWO_SIDED|90.0|-7.1|10.9|||ANCOVA|||||10.9|-7.1|0.73
70978231|NCT03124459|141464524|SUPERIORITY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|4.7||0.51|TWO_SIDED|90.0|-4.6|10.9|||ANCOVA|||||10.9|-4.6|0.51
70978232|NCT03124459|141464529|SUPERIORITY||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|3.9||0.63|TWO_SIDED|90.0|-8.4|4.6|||ANCOVA|||||4.6|-8.4|0.63
70978233|NCT02886702|141464606|EQUIVALENCE|90% confidence interval on the difference between the proportions to be within \[-20%, +20%\].|Risk Difference (RD)|-4.5||||||90.0|-12.6|3.6||p-value not calculated|Yates' corrected confidence interval|||||3.6|-12.6|
70978234|NCT02886702|141464606|SUPERIORITY|Last Observation Carried Forward (LOCF) for missing efficacy values||||||0.352|||||||Cochran-Mantel-Haenszel|stratified by clinical site||||||0.3520
70978235|NCT02886702|141464607|SUPERIORITY|||||||0.8105|||||||Cochran-Mantel-Haenszel|stratified by clinical site||||||0.8105
70978236|NCT02886702|141464607|SUPERIORITY|||||||0.0613|||||||Cochran-Mantel-Haenszel|stratified by clinical site||||||0.0613
70978237|NCT02886702|141464608|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|stratified by clinical site||||||1.0000
70978238|NCT02886702|141464608|SUPERIORITY|||||||0.0712|||||||Cochran-Mantel-Haenszel|stratified by clinical site||||||0.0712
70978239|NCT01355289|141464630|SUPERIORITY_OR_OTHER||Difference in % of Responders|31.62||||0.0236|TWO_SIDED|95.0|5.39|57.84|||Cochran-Mantel-Haenszel|||||57.84|5.39|0.0236
70978240|NCT01355289|141464630|SUPERIORITY_OR_OTHER||Difference in % of Responders|60.78||||0.0003|TWO_SIDED|95.0|36.3|85.27|||Cochran-Mantel-Haenszel|||||85.27|36.30|0.0003
70978241|NCT01355289|141464630|SUPERIORITY_OR_OTHER||Difference in % of Responders|58.4||||0.0003|TWO_SIDED|95.0|30.92|85.88|||Cochran-Mantel-Haenszel|||||85.88|30.92|0.0003
70978242|NCT00813995|141464647|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparison|ANCOVA|||||||<.001
70978243|NCT03618030|141464665|OTHER|||||||0.0003|||||||ANOVA|||The primary efficacy analysis used a mixed-model repeated measures (MMRM) analysis on the full day laboratory classroom PERMP-T scores.||||.0003
70978244|NCT01053312|141464668|NON_INFERIORITY_OR_EQUIVALENCE|The level of association between SUVR and the amyloid levels was analyzed using a regression model.|R²|0.688||||0.098|TWO_SIDED||||||Regression, Linear|||Contralateral to the biopsy Site||||0.098
70978245|NCT01053312|141464668|NON_INFERIORITY_OR_EQUIVALENCE|The level of association between SUVR and the amyloid levels was analyzed using a regression model.|R²|0.482||||0.268|||||||Regression, Linear|||Ipsilateral to the biopsy Site||||0.268
70978246|NCT01053312|141464668|NON_INFERIORITY_OR_EQUIVALENCE|The level of association between SUVR and the amyloid levels was analyzed using a regression model.|R²|0.685||||0.099|||||||Regression, Linear|||Composite Region||||0.099
70978247|NCT00473876|141464693|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.38||||0.08||95.0|||||t-test, 1 sided|The differences between baseline and post-intervention (4 months) was analyzed using independent t-test, comparing metformin and placebo.||Null hypothesis: Metformin has no effect on peak VO2. We targetted 66 subjects and power calculation based on our previous observational study of CHF with insulin resistance with mean peak VO2 of 11.||||0.08
70978248|NCT00473876|141464694|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.45|STANDARD_DEVIATION|10.72||0.034||95.0|||||t-test, 1 sided|Compare between metformin and placebo arm.||Null hypothesis: Metformin has no effect on the ratio between VCO2 (production of CO2) and VE (ventilation), it is also called the VE/VCO2 slope||||0.034
70978249|NCT00348140|141464695|SUPERIORITY||Mean Difference (Net)|0.3||||0.739|TWO_SIDED|95.0|-1.2|1.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||1.8|-1.2|0.739
70978250|NCT00348140|141464695|SUPERIORITY||Mean Difference (Net)|0.8||||0.343|TWO_SIDED|95.0|-0.8|2.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||2.4|-0.8|0.343
70978251|NCT00348140|141464696|SUPERIORITY||Mean Difference (Net)|-0.1||||0.783|TWO_SIDED|95.0|-1.1|0.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.9|-1.1|0.783
70978252|NCT00348140|141464696|SUPERIORITY||Mean Difference (Net)|0.0||||0.94|TWO_SIDED|95.0|-1.1|1.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||1.1|-1.1|0.940
71034516|NCT03393208|141578389|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LS Mean Percentage|98.67||||||90.0|91.25|106.69||||||Statistical Comparison of Treatment A Versus Treatment B in Fed state||106.69|91.25|
71034517|NCT03393208|141578390|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LS Mean Percentage|99.62||||||90.0|92.69|106.77||||||Statistical Comparison of Treatment A Versus Treatment B in Fasting state||106.77|92.69|
71034518|NCT03393208|141578390|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LS Mean Percentage|101.5||||||90.0|93.72|109.92||||||Statistical Comparison of Treatment A Versus Treatment B in Fed state||109.92|93.72|
70978253|NCT00348140|141464697|SUPERIORITY||Mean Difference (Net)|-0.1|||=|0.763|TWO_SIDED|95.0|-1.1|0.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.8|-1.1|=0.763
70978254|NCT00348140|141464697|SUPERIORITY||Mean Difference (Net)|-0.1|||=|0.8|TWO_SIDED|95.0|-1.1|0.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.9|-1.1|=0.800
70978255|NCT00348140|141464698|SUPERIORITY||Mean Difference (Net)|-0.1||||0.611|TWO_SIDED|95.0|-0.7|0.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.4|-0.7|0.611
71034519|NCT03393208|141578391|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Median Difference|0.0|||||TWO_SIDED|90.0|-0.25|0.25||||||Statistical Comparison of Treatment A Versus Treatment B in Fasting state||0.25|-0.25|
71034520|NCT03393208|141578391|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Median Difference|0.25||||||90.0|-0.25|0.5||||||Statistical Comparison of Treatment A Versus Treatment B in Fed state||0.50|-0.25|
71034521|NCT03393208|141578393|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LS Mean Percentage|101.26||||||90.0|94.33|108.69||||||Statistical Comparison of Treatment A Versus Treatment B in Fasting state||108.69|94.33|
71034522|NCT03393208|141578393|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LS Mean Percentage|98.17|||||TWO_SIDED|90.0|91.61|105.21||||||Statistical Comparison of Treatment A Versus Treatment B in Fed state||105.21|91.61|
71034523|NCT00207090|141578403|SUPERIORITY_OR_OTHER_LEGACY||Point estimate|0.912|||||TWO_SIDED|90.0|0.751|1.106||||||Two-way analyses of variance were performed on log-transformed values of Cmax. The factors in the analyses were participant and day. Point estimates and 90% confidence intervals for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale.||1.106|0.751|
71034524|NCT00207090|141578404|SUPERIORITY_OR_OTHER_LEGACY||Point estimate|0.566|||||TWO_SIDED|90.0|0.482|0.664||||||Two-way analyses of variance were performed on log-transformed values of (AUC \[INF\]). The factors in the analyses were participant and day. Point estimates and 90% confidence intervals for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale.||0.664|0.482|
71034525|NCT00304187|141578421|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<.05
71034526|NCT03374176|141578439|EQUIVALENCE||Mean Difference (Net)|0.05|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||||chi-square|||<0.05
71034527|NCT02911701|141578444|SUPERIORITY|||||||0.3|||||||maxim|||||||0.3
71034528|NCT01237054|141578465|SUPERIORITY|||||||0.024||||||The reported p-value is representative of the difference in levels of Ang2 in both groups.|Wilcoxon rank sum test|||||||0.024
71034529|NCT01237054|141578465|SUPERIORITY|||||||0.055||||||The reported p-value is representative of the difference in levels of G-CSF in both groups.|Wilcoxon rank sum test|||||||0.055
71034530|NCT01237054|141578465|SUPERIORITY|||||||0.055||||||The reported p-value is representative of the difference in levels of Follistatin in both groups.|Wilcoxon rank sum test|||||||0.055
71034531|NCT01237054|141578465|SUPERIORITY|||||||0.0098||||||The reported p-value is representative of the difference in levels of HGF in both groups.|Wilcoxon rank sum test|||||||0.0098
71034532|NCT01237054|141578465|SUPERIORITY|||||||0.02||||||The reported p-value is representative of the difference in levels of VEGF-A in both groups.|Wilcoxon rank sum test|||||||0.02
71034533|NCT01237054|141578466|OTHER|Other, trend test.||||||0.008|||||||Jonckheere-Terpstra test for trend|||||||0.008
71034534|NCT01237054|141578467|OTHER|Other, trend test.||||||0.15||||||The reported p-value is representative of the difference in levels of Kep between MGUS and SMM+MM.|Jonckheere-Terpstra test for trend|||||||0.15
71034535|NCT01237054|141578467|OTHER|Other, trend test.||||||0.33||||||The reported p-value is representative of the difference in levels of Ktrans between MGUS and SMM+MM.|Jonckheere-Terpstra test for trend|||||||0.33
71034536|NCT01237054|141578468|SUPERIORITY|||||||0.08|||||||Wilcoxon rank sum test|||||||0.08
71034537|NCT01237054|141578469|SUPERIORITY|||||||0.011|||||||Wilcoxon rank sum test|||||||0.011
71034538|NCT00520234|141578475|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Cochran-Mantel-Haenszel|APACHE II Stratified||||||0.14
71034539|NCT03804983|141578521|OTHER|Analysis of Variance||||||0.178||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.178
71034540|NCT03804983|141578522|OTHER|Analysis of Variance||||||0.145||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.145
71034541|NCT03804983|141578523|OTHER|Analysis of Variance||||||0.304||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.304
71034542|NCT03804983|141578524|OTHER|Analysis of Variance||||||0.131||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.131
71034543|NCT03804983|141578526|OTHER|Analysis of Variance||||||0.206||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.206
71034544|NCT03804983|141578527|OTHER|Analysis of Variance||||||0.335||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.335
70978256|NCT00348140|141464698|SUPERIORITY||Mean Difference (Net)|-0.1||||0.741|TWO_SIDED|95.0|-0.6|0.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.4|-0.6|0.741
70978257|NCT00348140|141464699|SUPERIORITY||Mean Difference (Net)|0.0||||0.913|TWO_SIDED|95.0|-0.4|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.3|-0.4|0.913
70978258|NCT00348140|141464699|SUPERIORITY||Mean Difference (Net)|-0.1||||0.481|TWO_SIDED|95.0|-0.5|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.2|-0.5|0.481
70978259|NCT00348140|141464700|SUPERIORITY||Mean Difference (Net)|-0.1||||0.557|TWO_SIDED|95.0|-0.4|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.2|-0.4|0.557
70978260|NCT00348140|141464700|SUPERIORITY||Mean Difference (Net)|-0.1||||0.404|TWO_SIDED|95.0|-0.5|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.2|-0.5|0.404
70978261|NCT00348140|141464701|SUPERIORITY||Mean Difference (Net)|0.1||||0.633|TWO_SIDED|95.0|-0.5|0.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8||0.8|-0.5|0.633
70978262|NCT00348140|141464701|SUPERIORITY||Mean Difference (Net)|0.2||||0.575|TWO_SIDED|95.0|-0.4|0.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8||0.8|-0.4|0.575
70978263|NCT00348140|141464701|SUPERIORITY||Mean Difference (Net)|0.1||||0.82|TWO_SIDED|95.0|-0.6|0.7|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 16||0.7|-0.6|0.820
71096126|NCT00827242|141700977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|1.12|<|0.001||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IIEF-EF domain score. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||<0.001
70978264|NCT00348140|141464701|SUPERIORITY||Mean Difference (Net)|0.0||||0.908|TWO_SIDED|95.0|-0.7|0.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 16||0.6|-0.7|0.908
70978265|NCT00348140|141464701|SUPERIORITY||Mean Difference (Net)|0.4||||0.292|TWO_SIDED|95.0|-0.3|1.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||1.1|-0.3|0.292
71096127|NCT00827242|141700978|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||The p-value associates with mean difference of changes from baseline to 12 weeks between treatment groups for Qmax. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ranked ANOVA|||||||0.300
70978266|NCT00348140|141464701|SUPERIORITY||Mean Difference (Net)|0.0||||0.978|TWO_SIDED|95.0|-0.7|0.7|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||0.7|-0.7|0.978
70978267|NCT00348140|141464701|SUPERIORITY||Mean Difference (Net)|0.2||||0.691|TWO_SIDED|95.0|-0.6|1.0|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36||1.0|-0.6|0.691
70978268|NCT00348140|141464701|SUPERIORITY||Mean Difference (Net)|-0.1||||0.849|TWO_SIDED|95.0|-0.9|0.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36||0.8|-0.9|0.849
70978269|NCT00348140|141464702|SUPERIORITY||Mean Difference (Net)|0.0||||0.938|TWO_SIDED|95.0|-0.2|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 12||0.2|-0.2|0.938
70978270|NCT00348140|141464702|SUPERIORITY||Mean Difference (Net)|0.0||||0.887|TWO_SIDED|95.0|-0.2|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 12||0.2|-0.2|0.887
70978271|NCT00348140|141464702|SUPERIORITY||Mean Difference (Net)|-0.1||||0.465|TWO_SIDED|95.0|-0.4|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||0.2|-0.4|0.465
71096128|NCT00827242|141700981|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||The p-value associates with mean difference of changes from baseline to 12 weeks between treatment groups for PVR volume. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ranked ANOVA|||||||0.500
71096129|NCT00514917|141701035|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.0501|TWO_SIDED|95.0|1.0|1.65||A priori threshold for statistical significance = 0.05|Log Rank|P-value was not adjusted for multiplicity of tests.|The hazard ratio Leuprolide+Bicalutamide vs. Docetaxel+Leuprolide+Bicalutamide was estimated using an un-stratified Cox proportional hazards model. A hazard ratio \>1 indicates a lower risk of Docetaxel+Leuprolide, compared to Leuprolide.|"Null hypothesis: No difference between new treatment combination (Docetaxel+Leuprolide+Bicalutamide) and conventional treatment (Leuprolide+Bicalutamide).~The study was sized to have 90% power to detect a difference between treatment arms at a 2-sided 0.05 significance level with 186 events and anticipating 10% non-evaluable participants."||1.65|1.00|0.0501
71096130|NCT02697422|141701046|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
70978272|NCT00348140|141464702|SUPERIORITY||Mean Difference (Net)|0.1||||0.596|TWO_SIDED|95.0|-0.2|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||0.3|-0.2|0.596
70978273|NCT00348140|141464702|SUPERIORITY||Mean Difference (Net)|-0.1||||0.452|TWO_SIDED|95.0|-0.4|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36||0.2|-0.4|0.452
71096131|NCT02697422|141701047|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
71096132|NCT02697422|141701048|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
71096133|NCT02697422|141701049|SUPERIORITY|||||||0.9|TWO_SIDED|95.0||||Smoker/tobacco use results were calculated using logistic regression.|Regression, Logistic|||Smoker/tobacco use results were calculated using logistic regression. A P value of .90 was found comparing smoking/tobacco use in intervention vs control participants. A difference was not reported between intervention and control because smoking/ tobacco use was a binary variable.||||0.90
70978274|NCT00348140|141464702|SUPERIORITY||Mean Difference (Net)|-0.1||||0.429|TWO_SIDED|95.0|-0.4|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36||0.2|-0.4|0.429
70978275|NCT00348140|141464703|SUPERIORITY||Mean Difference (Net)|-0.3||||0.386|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||||0.3|-0.8|0.386
70978276|NCT00348140|141464703|SUPERIORITY||Mean Difference (Net)|0.0||||0.999|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|||||0.6|-0.6|0.999
70978277|NCT00348140|141464704|SUPERIORITY||Mean Difference (Net)|1.1||||0.09|TWO_SIDED|95.0|-0.2|2.5|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8||2.5|-0.2|0.090
71096134|NCT02697422|141701050|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
71096135|NCT02697422|141701051|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
70978278|NCT00348140|141464704|SUPERIORITY||Mean Difference (Net)|0.0||||0.957|TWO_SIDED|95.0|-1.3|1.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8||1.3|-1.3|0.957
70978279|NCT00348140|141464704|SUPERIORITY||Mean Difference (Net)|0.7||||0.395|TWO_SIDED|95.0|-0.9|2.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 16||2.2|-0.9|0.395
70978280|NCT00348140|141464704|SUPERIORITY||Mean Difference (Net)|-0.9||||0.275|TWO_SIDED|95.0|-2.5|0.7|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 16||0.7|-2.5|0.275
70978281|NCT00348140|141464704|SUPERIORITY||Mean Difference (Net)|1.7||||0.039|TWO_SIDED|95.0|0.1|3.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||3.4|0.1|0.039
70978282|NCT00348140|141464704|SUPERIORITY||Mean Difference (Net)|-0.1||||0.895|TWO_SIDED|95.0|-1.8|1.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||1.6|-1.8|0.895
70978283|NCT00348140|141464704|SUPERIORITY||Mean Difference (Net)|0.1||||0.914|TWO_SIDED|95.0|-2.1|2.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||2.3|-2.1|0.914
70978284|NCT00348140|141464704|SUPERIORITY||Mean Difference (Net)|-0.9||||0.43|TWO_SIDED|95.0|-3.2|1.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||1.3|-3.2|0.430
71096136|NCT02697422|141701052|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
71096137|NCT02697422|141701053|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
71096138|NCT02697422|141701054|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
71096139|NCT02697422|141701055|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
71034545|NCT03804983|141578528|OTHER|Analysis of Variance||||||0.637||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.637
71096140|NCT01659541|141701057|OTHER|Statistical analyses were performed using a repeated measures analysis of variance and Paired t test. A p value was calculated.|||||<|0.05|||||||ANOVA|Statistical analyses will be performed using a repeated measures analysis of variance and Paired t test.||Each patient was served as their own control (Pre-Implant); comparisons was made at various points in the study (Week #28, #40 and #52).||||<0.05
71096141|NCT01659541|141701058|OTHER|Statistical analyses were performed using a repeated measures analysis of variance and Paired t test. A p value was calculated.|||||<|0.05|||||||ANOVA|Statistical analyses will be performed using a repeated measures analysis of variance and Paired t test.||Each patient was served as their own control (Pre-Implant); comparisons were made at various points in the study (Week #28, #40 and #52).||||<0.05
71096142|NCT01659541|141701059|OTHER||||||<|0.05|||||||nonparametric analog (Freidman Test)|||The data prior to implantation (Pre-Implant)) were compared with data obtained after implantation (Week ##28, #40, #52) of the cough system using a nonparametric analog (Friedman Test) to the standard repeated measures analysis of variance. A p value was calculated. This alpha level was chosen as a correlation for inflated type I error rates because of multiple comparisons. Results are reported as means ± Standard Error.||||<0.05
70922448|NCT01631214|141335825|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|LS Mean Difference|7.4|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|6.84|7.89|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||7.89|6.84|<0.001
70922449|NCT01631214|141335826|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|LS Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|3.29|4.02|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||4.02|3.29|<0.001
70922450|NCT01631214|141335827|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|LS Mean Difference|3.6|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|3.18|3.97|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||3.97|3.18|<0.001
70922451|NCT02488863|141335895|OTHER|ANOVA||||||0.0561|||||||ANOVA|||H0: mean(SPPB\_older\_pain) = mean(SPPB\_older\_no pain) = mean(SPPB\_younger)||||0.0561
70922452|NCT01046136|141335896|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0096|||||||Regression, Logistic|p-value is from a logistic regression model with terms for treatment group and center||Investigator's End-of-Study Assessment NOTE: All assessments of efficacy were considered exploratory and were given equal consideration, and were carried out on both the MITT and PP populations. LOCF method was applied to missing post baseline measurements in analyses of the MITT population.||||0.0096
70922453|NCT01046136|141335898|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0293|||||||Wilcoxon (Mann-Whitney)|P-value is from a Wilcoxon rank sum test comparing the two treatment groups.||||||0.0293
70922454|NCT01989455|141335922|SUPERIORITY_OR_OTHER||Percent ratio|73.19|||||TWO_SIDED|90.0|68.83|77.56||||||||77.56|68.83|
70922455|NCT00632203|141335924|SUPERIORITY_OR_OTHER|||||||0.6995|||||||2-sided Exact Pearson Chi-square Test|||||||0.6995
70922456|NCT02641912|141335931|SUPERIORITY_OR_OTHER||Least sqaure (LS) mean difference|0.63||||0.0084|TWO_SIDED|95.0|0.17|1.1|||ANOVA|From ANOVA model with factors for treatment and confirmed Sjögren's syndrome status stratification using Observed Margins option.|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|||1.10|0.17|0.0084
70922457|NCT04238247|141335963|SUPERIORITY||Odds Ratio (OR)|1.876119||||0.006|TWO_SIDED|95.0|1.193531|2.949084||The threshold for statistical significance was p = 0.05.|Regression, Logistic|We conducted logistic regression adjusted for randomization strata (recommended CRS and reason for eligibility).||We hypothesized the intervention group would have greater child passenger safety guideline adherence at 6 months compared with enhanced usual care group. In planning the trial, we assumed 75% of TCBD caregivers would be re-randomized. Baseline randomization was stratified by recommended CRS (rear-facing seat, forward-facing seat, booster seat) and reason for eligibility (not using the recommended CRS at baseline or planning a premature transition in the next 6 months).||2.949084|1.193531|0.006
70922458|NCT04238247|141335964|SUPERIORITY||Odds Ratio (OR)|0.8686678||||0.671|TWO_SIDED|95.0|0.4535589|1.663695||The threshold for statistical significance was p = 0.05.|Regression, Logistic|||This analysis is limited to the Phase 2 participants who were re-randomized at 6 months to test the hypothesis that the enhanced intervention (with booster MI session) would have greater guideline adherent child passenger safety behaviors at 12 month follow-up than the group that continued in the basic intervention (mHealth components).||1.663695|0.4535589|0.671
70922459|NCT04238247|141335964|SUPERIORITY||Odds Ratio (OR)|6.859599|||<|0.001|TWO_SIDED|95.0|3.173121|14.82896|||Regression, Logistic|||||14.82896|3.173121|<0.001
70922460|NCT04238247|141335967|SUPERIORITY||Odds Ratio (OR)|1.74029||||0.032|TWO_SIDED|95.0|1.049169|2.886676||The threshold for statistical significance was p = 0.05.|Regression, Logistic|||||2.886676|1.049169|0.032
70922461|NCT04238247|141335968|SUPERIORITY||Odds Ratio (OR)|1.112874||||0.752|TWO_SIDED|95.0|0.5735782|2.159233||The threshold for statistical significance was p = 0.05.|Regression, Logistic|||||2.159233|0.5735782|0.752
71034546|NCT03804983|141578529|OTHER|Analysis of Variance||||||0.347||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.347
71096143|NCT01659541|141701060|OTHER||||||<|0.05|||||||nonparametric analog (Freidman Test)|||The data prior to implantation (Pre-Implant) were compared with data obtained after implantation (Week #28, #40, #52) of the cough system using a nonparametric analog (Friedman Test) to the standard repeated measures analysis of variance. A p value was calculated. This alpha level was chosen as a correlation for inflated type I error rates because of multiple comparisons. Results are reported as means ± Standard Error.||||<0.05
71096144|NCT01659541|141701061|OTHER||||||<|0.05|||||||nonparametric analog (Freidman Test)|||The data prior to implantation (Pre-Implant) were compared with data obtained after implantation (Week #28 ,#40, #52) of the cough system using a nonparametric analog (Friedman Test) to the standard repeated measures analysis of variance. Paired t test. A p value was calculated. This alpha level was chosen as a correlation for inflated type I error rates because of multiple comparisons. Results are reported as means ± Standard Error.||||<0.05
71096145|NCT01659541|141701062|OTHER||||||<|0.05|||||||nonparametric analog (Freidman Test)|||The data prior to implantation (Pre-Implant) were compared with data obtained after implantation (Week #28, #40, #52) of the cough system using a nonparametric analog (Friedman Test) to the standard repeated measures analysis of variance. A p value was calculated. This alpha level was chosen as a correlation for inflated type I error rates because of multiple comparisons. Results are reported as means ± Standard Error.||||<0.05
70978285|NCT00348140|141464705|SUPERIORITY||Mean Difference (Net)|-0.2||||0.583|TWO_SIDED|95.0|-1.1|0.6|||Mixed model for repeated measures|||For Week 8||0.6|-1.1|0.583
70978286|NCT00348140|141464705|SUPERIORITY||Mean Difference (Net)|-0.2||||0.631|TWO_SIDED|95.0|-1.1|0.6|||Mixed model for repeated measures|||For Week 8||0.6|-1.1|0.631
70978287|NCT00348140|141464705|SUPERIORITY||Mean Difference (Net)|0.1||||0.812|TWO_SIDED|95.0|-0.8|1.1|||Mixed model for repeated measures|||For Week 16||1.1|-0.8|0.812
70978288|NCT00348140|141464705|SUPERIORITY||Mean Difference (Net)|0.0||||0.952|TWO_SIDED|95.0|-0.9|1.0|||Mixed model for repeated measures|||For Week 16||1.0|-0.9|0.952
70978289|NCT00348140|141464705|SUPERIORITY||Mean Difference (Net)|-0.9||||0.117|TWO_SIDED|95.0|-2.1|0.2|||Mixed model for repeated measures|||For Week 24||0.2|-2.1|0.117
70978290|NCT00348140|141464705|SUPERIORITY||Mean Difference (Net)|-1.0||||0.074|TWO_SIDED|95.0|-2.1|0.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||0.1|-2.1|0.074
70978291|NCT00348140|141464705|SUPERIORITY||Mean Difference (Net)|-1.0||||0.141|TWO_SIDED|95.0|-2.4|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||0.3|-2.4|0.141
70978292|NCT00348140|141464705|SUPERIORITY||Mean Difference (Net)|-0.7||||0.331|TWO_SIDED|95.0|-2.1|0.7|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||0.7|-2.1|0.331
70978293|NCT00348140|141464706|SUPERIORITY||Mean Difference (Net)|4.1||||0.251|TWO_SIDED|95.0|-2.9|11.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 12||11.2|-2.9|0.251
70978294|NCT00348140|141464706|SUPERIORITY||Mean Difference (Net)|5.9||||0.113|TWO_SIDED|95.0|-1.4|13.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 12||13.2|-1.4|0.113
70978295|NCT00348140|141464706|SUPERIORITY||Mean Difference (Net)|1.6||||0.723|TWO_SIDED|95.0|-7.1|10.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 24||10.2|-7.1|0.723
70978296|NCT00348140|141464706|SUPERIORITY||Mean Difference (Net)|3.5||||0.482|TWO_SIDED|95.0|-6.3|13.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 24||13.2|-6.3|0.482
70978297|NCT00348140|141464706|SUPERIORITY||Mean Difference (Net)|1.5||||0.785|TWO_SIDED|95.0|-9.5|12.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 36||12.6|-9.5|0.785
70978298|NCT00348140|141464706|SUPERIORITY||Mean Difference (Net)|2.2||||0.711|TWO_SIDED|95.0|-9.4|13.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 36||13.8|-9.4|0.711
70978299|NCT00348140|141464706|SUPERIORITY||Mean Difference (Net)|4.0||||0.484|TWO_SIDED|95.0|-7.2|15.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 48||15.2|-7.2|0.484
71096146|NCT01222351|141701063|EQUIVALENCE|The null hypothesis was that there is no difference in the rate of cognitive decline between participants with and without amyloid.|Slope|-0.034||||0.02|TWO_SIDED||||||latent growth curve model|Latent growth curve models tested cognitive decline rate by amyloid status.|B weights were the estimates for the association between Aβ and cognitive change.|||||0.02
70978300|NCT00348140|141464706|SUPERIORITY||Mean Difference (Net)|3.4||||0.572|TWO_SIDED|95.0|-8.5|15.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 48||15.4|-8.5|0.572
70978301|NCT00348140|141464706|SUPERIORITY||Mean Difference (Net)|6.8||||0.197|TWO_SIDED|95.0|-3.6|17.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 12||17.3|-3.6|0.197
70978302|NCT00348140|141464706|SUPERIORITY||Mean Difference (Net)|7.4||||0.183|TWO_SIDED|95.0|-3.5|18.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 12||18.4|-3.5|0.183
70978303|NCT00348140|141464706|SUPERIORITY||Mean Difference (Net)|10.0||||0.121|TWO_SIDED|95.0|-2.6|22.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 24||22.6|-2.6|0.121
70978304|NCT00348140|141464706|SUPERIORITY||Mean Difference (Net)|6.8||||0.291|TWO_SIDED|95.0|-5.8|19.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 24||19.3|-5.8|0.291
70978305|NCT00348140|141464706|SUPERIORITY||Mean Difference (Net)|7.0||||0.389|TWO_SIDED|95.0|-8.9|22.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 36||22.9|-8.9|0.389
70978306|NCT00348140|141464706|SUPERIORITY||Mean Difference (Net)|-1.2||||0.865|TWO_SIDED|95.0|-15.0|12.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 36||12.6|-15.0|0.865
70978307|NCT00348140|141464706|SUPERIORITY||Mean Difference (Net)|4.2||||0.596|TWO_SIDED|95.0|-11.3|19.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 48||19.6|-11.3|0.596
70978308|NCT00348140|141464706|SUPERIORITY||Mean Difference (Net)|-0.2||||0.975|TWO_SIDED|95.0|-14.7|14.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 48||14.2|-14.7|0.975
70978309|NCT00348140|141464707|SUPERIORITY||Mean Difference (Net)|-2.4||||0.043|TWO_SIDED|95.0|-4.7|-0.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 12||-0.1|-4.7|0.043
70978310|NCT00348140|141464707|SUPERIORITY||Mean Difference (Net)|-2.2||||0.056|TWO_SIDED|95.0|-4.5|0.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 12||0.1|-4.5|0.056
70978311|NCT00348140|141464707|SUPERIORITY||Mean Difference (Net)|-0.4||||0.758|TWO_SIDED|95.0|-2.8|2.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 36||2.1|-2.8|0.758
70978312|NCT00348140|141464707|SUPERIORITY||Mean Difference (Net)|-2.0||||0.109|TWO_SIDED|95.0|-4.5|0.5|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 36||0.5|-4.5|0.109
70978313|NCT00348140|141464707|SUPERIORITY||Mean Difference (Net)|-2.6||||0.05|TWO_SIDED|95.0|-5.2|0.0|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 48||-0.0|-5.2|0.050
71034547|NCT03804983|141578530|OTHER|Analysis of Variance||||||0.057||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.057
71034548|NCT03804983|141578531|OTHER|Analysis of Variance||||||0.435||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.435
71034549|NCT03804983|141578532|OTHER|Analysis of Variance||||||0.135||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.135
71034550|NCT03804983|141578533|OTHER|Analysis of Variance||||||0.271||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.271
71034551|NCT03804983|141578534|OTHER|Analysis of Variance||||||1||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||1.0
71096147|NCT03055507|141701069|SUPERIORITY||Mean Difference (Final Values)|-0.9|||<|0.05|TWO_SIDED|96.0|-2.4|0.5|||t-test, 1 sided|||||0.5|-2.4|<0.05
71096148|NCT02068599|141701083|SUPERIORITY||LSM difference from placebo|4.26||||0.1213|TWO_SIDED|95.0|-1.13|9.66||5% level of significance|mixed model for repeated measures|||LSM = least square mean||9.66|-1.13|0.1213
70922462|NCT04238247|141335968|SUPERIORITY||Odds Ratio (OR)|7.959981|||<|0.001|TWO_SIDED|95.0|3.321933|19.07362|||Regression, Logistic|||||19.07362|3.321933|<0.001
70922463|NCT05064735|141335969|SUPERIORITY||Estimated Treatment Difference|-10.48|||<|0.0001|TWO_SIDED|95.0|-12.34|-8.63|||ANCOVA|||The responses at week 68 were analyzed using an analysis of covariance model with randomized treatment as factor and baseline body weight as covariate.||-8.63|-12.34|<0.0001
70922464|NCT05064735|141335970|SUPERIORITY||Estimated Treatment Difference|-14.14|||<|0.0001|TWO_SIDED|95.0|-19.98|-8.3|||ANCOVA|||The responses at week 68 were analyzed using an analysis of covariance model with randomized treatment as factor and baseline WOMAC pain score as covariate.||-8.30|-19.98|<0.0001
70922465|NCT02376790|141336000|SUPERIORITY||Treatment Difference|13.9||||0.005|TWO_SIDED|95.0|5.8|22.0||Adjusted p-value was obtained by applying a Bonferroni-based testing procedure for multiplicity adjustment to control the family-wise, two-sided type one error rate at 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|The primary hypothesis of this study is that etanercept plus methotrexate therapy and etanercept monotherapy are more efficacious than methotrexate monotherapy as measured by the percentage of participants with psoriatic arthritis achieving ACR 20 response at week 24.||22.0|5.8|0.005
70922466|NCT02376790|141336000|SUPERIORITY||Treatment Difference|9.2||||0.029|TWO_SIDED|95.0|1.0|17.3||Adjusted p-value was obtained by applying a Bonferroni-based testing procedure for multiplicity adjustment to control the family-wise, two-sided type one error rate at 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|The primary hypothesis of this study is that etanercept plus methotrexate therapy and etanercept monotherapy are more efficacious than methotrexate monotherapy as measured by the percentage of participants with psoriatic arthritis achieving ACR 20 response at week 24.||17.3|1.0|0.029
70922467|NCT02376790|141336001|SUPERIORITY||Treatment Difference|12.2||||0.005|TWO_SIDED|95.0|4.9|19.6||Adjusted p-value was obtained by applying a Bonferroni-based testing procedure for multiplicity adjustment to control the family-wise, two-sided type one error rate at 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|The secondary hypothesis of this study was that etanercept plus methotrexate therapy and etanercept monotherapy are more efficacious than methotrexate monotherapy as measured by the percentage of participants with PsA achieving MDA response at week 24.||19.6|4.9|0.005
70922468|NCT02376790|141336001|SUPERIORITY||Treatment Difference|11.6||||0.005|TWO_SIDED|95.0|4.2|18.9||Adjusted p-value was obtained by applying a Bonferroni-based testing procedure for multiplicity adjustment to control the family-wise, two-sided type one error rate at 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|The secondary hypothesis of this study was that etanercept plus methotrexate therapy and etanercept monotherapy are more efficacious than methotrexate monotherapy as measured by the percentage of participants with PsA achieving MDA response at week 24.||18.9|4.2|0.005
70922469|NCT02376790|141336003|SUPERIORITY||Treatment Difference|14.7|||<|0.001|TWO_SIDED|95.0|6.4|23.0||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of the percentage of participants with an ACR50 response at week 24.||23.0|6.4|<0.001
70922470|NCT02376790|141336003|SUPERIORITY||Treatment Difference|11.8||||0.006|TWO_SIDED|95.0|3.4|20.2||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of the percentage of participants with an ACR50 response at week 24.||20.2|3.4|0.006
70978314|NCT00348140|141464707|SUPERIORITY||Mean Difference (Net)|-3.4||||0.009|TWO_SIDED|95.0|-6.0|-0.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 48||-0.9|-6.0|0.009
70978315|NCT00348140|141464708|SUPERIORITY||Mean Difference (Net)|0.01||||0.662|TWO_SIDED|95.0|-0.02|0.03|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Ultility score Week 12||0.03|-0.02|0.662
70978316|NCT00348140|141464708|SUPERIORITY||Mean Difference (Net)|-0.01||||0.503|TWO_SIDED|95.0|-0.03|0.02|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Ultility score Week 12||0.02|-0.03|0.503
70978317|NCT00348140|141464708|SUPERIORITY||Mean Difference (Net)|0.0||||0.892|TWO_SIDED|95.0|-0.03|0.03|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Utility score Week 36||0.03|-0.03|0.892
71096149|NCT02068599|141701083|SUPERIORITY||LSM difference from placebo|1.74||||0.5231|TWO_SIDED|95.0|-3.62|7.11||5% level of significance|mixed model for repeated measures|||LSM = least square mean||7.11|-3.62|0.5231
71096150|NCT02068599|141701084|SUPERIORITY||LSM difference from placebo|17.86||||0.1795|TWO_SIDED|95.0|-8.26|43.98||5% level of significance|mixed model for repeated measures|||LSM = least square mean||43.98|-8.26|0.1795
71096151|NCT02068599|141701084|SUPERIORITY||LSM difference from placebo|9.0||||0.4956|TWO_SIDED|95.0|-16.95|34.96||5% level of significance|mixed model for repeated measures|||LSM = least square mean||34.96|-16.95|0.4956
71096152|NCT02068599|141701085|SUPERIORITY||LSM difference from placebo|3.61||||0.1963|TWO_SIDED|95.0|-1.87|9.08||5% level of significance|mixed model for repeated measures|||||9.08|-1.87|0.1963
71096153|NCT02068599|141701085|SUPERIORITY||LSM difference from placebo|2.06||||0.4584|TWO_SIDED|95.0|-3.39|7.5||5% level of significance|mixed model for repeated measures|||||7.50|-3.39|0.4584
71096154|NCT02068599|141701086|SUPERIORITY||LSM difference from placebo|23.51||||0.642|TWO_SIDED|95.0|-75.83|122.84||5% level of significance|mixed model for repeated measures|||||122.84|-75.83|0.6420
71096155|NCT02068599|141701086|SUPERIORITY||LSM difference from placebo|-50.4||||0.3141|TWO_SIDED|95.0|-148.72|47.92||5% level of significance|mixed model for repeated measures|||||47.92|-148.72|0.3141
71096156|NCT02068599|141701087|SUPERIORITY||LSM difference from placebo|3.16||||0.6184|TWO_SIDED|95.0|-9.31|15.63||5% level of significance|mixed model for repeated measures|||||15.63|-9.31|0.6184
71096157|NCT02068599|141701087|SUPERIORITY||LSM difference from placebo|-3.48||||0.5775|TWO_SIDED|95.0|-15.78|8.81||5% level of significance|mixed model for repeated measures|||||8.81|-15.78|0.5775
71096158|NCT02068599|141701088|SUPERIORITY||Odds Ratio (OR)|0.62||||0.1011|TWO_SIDED|95.0|0.345|1.099||5% level of significance|mixed model for repeated measures|||\>=50% responder rate||1.099|0.345|0.1011
71096159|NCT02068599|141701088|SUPERIORITY||Odds Ratio (OR)|1.06||||0.84|TWO_SIDED|95.0|0.615|1.819||5% level of significance|mixed model for repeated measures|||\>=50% responder rate||1.819|0.615|0.8400
70978318|NCT00348140|141464708|SUPERIORITY||Mean Difference (Net)|-0.03||||0.083|TWO_SIDED|95.0|-0.05|0.0|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Utility score Week 36||0.00|-0.05|0.083
71096160|NCT02068599|141701088|SUPERIORITY||Odds Ratio (OR)|0.89||||0.6607|TWO_SIDED|95.0|0.531|1.494||5% level of significance|mixed model for repeated measures|||\>=30% responder rate||1.494|0.531|0.6607
71096161|NCT02068599|141701088|SUPERIORITY||Odds Ratio (OR)|0.87||||0.5777|TWO_SIDED|95.0|0.52|1.441||5% level of significance|mixed model for repeated measures|||\>=30% responder rate||1.441|0.520|0.5777
71096162|NCT02068599|141701089|SUPERIORITY||LSM difference from placebo|3.94||||0.4316|TWO_SIDED|95.0|-5.9|13.79||5% level of significance|mixed model for repeated measures|||||13.79|-5.90|0.4316
71096163|NCT02068599|141701089|SUPERIORITY||LSM difference from placebo|2.51||||0.6126|TWO_SIDED|95.0|-7.24|12.26||5% level of significance|mixed model for repeated measures|||||12.26|-7.24|0.6126
71096164|NCT02068599|141701090|SUPERIORITY||LSM difference from placebo|0.01||||0.9208|TWO_SIDED|95.0|-0.232|0.257||5% level of significance|mixed model for repeated measures|||Week 2||0.257|-0.232|0.9208
70978319|NCT00348140|141464708|SUPERIORITY||Mean Difference (Net)|-0.01||||0.366|TWO_SIDED|95.0|-0.05|0.02|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Utility score Week 48||0.02|-0.05|0.366
71096165|NCT02068599|141701090|SUPERIORITY||LSM difference from placebo|0.04||||0.7344|TWO_SIDED|95.0|-0.2|0.284||5% level of significance|mixed model for repeated measures|||Week 2||0.284|-0.200|0.7344
71096166|NCT02068599|141701090|SUPERIORITY||LSM difference from placebo|0.21||||0.1199|TWO_SIDED|95.0|-0.056|0.486||5% level of significance|mixed model for repeated measures|||Week 4||0.486|-0.056|0.1199
71096167|NCT02068599|141701090|SUPERIORITY||LSM difference from placebo|0.06||||0.6357|TWO_SIDED|95.0|-0.204|0.334||5% level of significance|mixed model for repeated measures|||Week 4||0.334|-0.204|0.6357
71096168|NCT02068599|141701091|SUPERIORITY||LSM difference from placebo|2.77||||0.2906|TWO_SIDED|95.0|-2.377|7.916||5% level of significance|mixed model for repeated measures|||Week 2||7.916|-2.377|0.2906
71096169|NCT02068599|141701091|SUPERIORITY||LSM difference from placebo|1.41||||0.5892|TWO_SIDED|95.0|-3.707|6.518||5% level of significance|mixed model for repeated measures|||Week 2||6.518|-3.707|0.5892
71096170|NCT02068599|141701091|SUPERIORITY||LSM difference from placebo|0.82||||0.7699|TWO_SIDED|95.0|-4.678|6.315||5% level of significance|mixed model for repeated measures|||Week 4||6.315|-4.678|0.7699
71096171|NCT02068599|141701091|SUPERIORITY||LSM difference from placebo|1.74||||0.532|TWO_SIDED|95.0|-3.721|7.193||5% level of significance|mixed model for repeated measures|||Week 4||7.193|-3.721|0.5320
71096172|NCT02068599|141701092|SUPERIORITY||Odds Ratio (OR)|0.85||||0.5358|TWO_SIDED|95.0|0.501|1.433||5% level of significance|generalized estimating equation (GEE)|||For the responder analyses, participants with missing values were deemed non-responders. Analysis performed using a generalized estimating equation (GEE) method where binary variable responder rate (Yes/No) was modeled through logit link function, with treatment, center, week, and treatment\*week as explanatory factors. The unstructured working correlation structure was applied.||1.433|0.501|0.5358
70978320|NCT00348140|141464708|SUPERIORITY||Mean Difference (Net)|0.0||||0.769|TWO_SIDED|95.0|-0.03|0.02|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Utility score Week 48||0.02|-0.03|0.769
70978321|NCT00348140|141464709|SUPERIORITY||Mean Difference (Net)|-0.2||||0.529|TWO_SIDED|95.0|-0.7|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 12||0.3|-0.7|0.529
70978322|NCT00348140|141464709|SUPERIORITY||Mean Difference (Net)|-0.1||||0.62|TWO_SIDED|95.0|-0.7|0.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 12||0.4|-0.7|0.620
70978323|NCT00348140|141464709|SUPERIORITY||Mean Difference (Net)|-0.4||||0.284|TWO_SIDED|95.0|-1.0|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 36||0.3|-1.0|0.284
71034552|NCT03804983|141578536|OTHER|Analysis of Variance||||||1||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||1.0
71034553|NCT03804983|141578537|OTHER|Analysis of Variance||||||0.294||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.294
71034554|NCT03804983|141578538|OTHER|Analysis of Variance||||||0.584||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.584
71034555|NCT03804983|141578539|OTHER|Analysis of Variance||||||0.69||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.69
71034556|NCT03804983|141578540|OTHER|Analysis of Variance||||||0.066||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.066
71034557|NCT03804983|141578541|OTHER|Analysis of Variance||||||0.904||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.904
71034558|NCT00424047|141578564|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.324|||<|0.001|TWO_SIDED|95.0|0.24|0.438|||Log Rank|The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups|Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (Lenalidomide/Dex:Placebo/Dexamethasone)|||0.438|0.240|<0.001
71034559|NCT00424047|141578565|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.105|TWO_SIDED|95.0|0.498|1.07|||Log Rank|The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.|Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (Lenalidomide/Dexamethasone:Placebo/Dexamethasone)|||1.070|0.498|0.105
71034560|NCT00424047|141578566|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.863||||0.302|TWO_SIDED|95.0|0.651|1.143|||Log Rank|The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups|Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (CC-5013/Dex:Placebo/Dex)|||1.143|0.651|0.302
71034561|NCT00424047|141578567|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Probability from Wilcoxon rank sum test||||||<0.001
71034562|NCT00424047|141578568|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Probability from Wilcoxon rank sum test||||||<0.001
71034563|NCT00424047|141578571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.558||||0.021|TWO_SIDED|95.0|0.338|0.921|||Log Rank|The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups|Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (lenalidomide/dexamethasone : placebo/dexamethasone).|||0.921|0.338|0.021
71034564|NCT00424047|141578572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.362|||<|0.001|TWO_SIDED|95.0|0.27|0.478||The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.|Log Rank||Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (CC-5013/Dex:Placebo/Dex)|||0.478|0.27|<0.001
71034565|NCT00424047|141578573|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.166||||0.271|TWO_SIDED|95.0|0.887|1.532||The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.|Log Rank||Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (lenalidomide/dexamethasone: placebo/dexamethasone)|||1.532|0.887|0.271
71034566|NCT00424047|141578574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.135||||0.359|TWO_SIDED|95.0|0.866|1.486||The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.|Log Rank||Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (CC-5013/Dex:Placebo/Dex)|||1.486|0.866|0.359
71034567|NCT00424047|141578575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.619||||0.032|TWO_SIDED|95.0|0.398|0.964|||Log Rank|The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.|Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (CC-5013/Dex:Placebo/Dex)|||0.964|0.398|0.032
71034568|NCT04633564|141578584|EQUIVALENCE|The equivalence region is (0.73, 1.36).|Risk Ratio (RR)|0.96|||||TWO_SIDED|90.0|0.83|1.12||||||||1.12|0.83|
71034569|NCT01097577|141578600|SUPERIORITY|||||||0.18|||||||ANOVA|||This study was designed to determine if pregabalin is an effective regimen for postoperative pain control following PRK. We hypothesized that there will be at least a 10% improvement in pain after PRK using a scheduled pregabalin dosing regimen compared to placebo. A power analysis was completed to determine the number of patients necessary.||||0.180
71034570|NCT01097577|141578601|SUPERIORITY|||||||0.207|||||||ANOVA|||||||0.207
71034571|NCT01097577|141578602|SUPERIORITY|||||||0.283|||||||ANOVA|||||||0.283
71034572|NCT01097577|141578603|SUPERIORITY|Question 1: Pain at its worst||||||0.223|||||||ANOVA|||||||0.223
71034573|NCT01097577|141578604|SUPERIORITY|||||||0.311|||||||ANOVA|||||||0.311
71034574|NCT01097577|141578605|SUPERIORITY|||||||0.581|||||||t-test, 2 sided|||Days to Heal, OD||||0.581
71096173|NCT02068599|141701092|SUPERIORITY||Odds Ratio (OR)|1.45||||0.1532|TWO_SIDED|95.0|0.87|2.423||5% level of significance|generalized estimating equation (GEE)|||For the responder analyses, participants with missing values were deemed non-responders. Analysis performed using a generalized estimating equation (GEE) method where binary variable responder rate (Yes/No) was modeled through logit link function, with treatment, center, week, and treatment\*week as explanatory factors. The unstructured working correlation structure was applied.||2.423|0.870|0.1532
71096174|NCT00309244|141701130|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was set to meet regulatory requirement of 250 subjects per arm with 52-week data, resulting in \> 90% power for a non-inferiority test of the difference in 12-month change of HbA1c scores between treatment groups with non-inferiority margin of 0.4%, standard deviation of 1.2 and 1-sided alpha of 0.025. Allowing for a 25% drop-out rate, 677 subjects were randomized.|Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.085|||TWO_SIDED|95.0|-0.05|0.29|||ANCOVA|||||0.29|-0.05|
71096175|NCT00309244|141701131|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6|STANDARD_ERROR_OF_MEAN|0.41||0.0002|TWO_SIDED|95.0|-2.4|-0.7|||ANCOVA|||ANCOVA model with terms of pooled site and treatment as fixed effects and baseline weight as covariate||-0.7|-2.4|0.0002
71096176|NCT00309244|141701132|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.7|STANDARD_ERROR_OF_MEAN|5.9||0.0029|TWO_SIDED|95.0|-29.3|-6.1|||ANCOVA|||ANCOVA model with terms of pooled site and treatment as fixed effects and baseline fasting plasma glucose as covariate||-6.1|-29.3|0.0029
71096177|NCT00309244|141701133|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.774||||0.2793|TWO_SIDED|95.0|0.486|1.231|||Regression, Logistic|||logistic regression analysis with the terms of treatment and baseline HbA1c in the model||1.231|0.486|0.2793
71096178|NCT00309244|141701134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.423|||<|0.001|TWO_SIDED|95.0|0.307|0.581|||Regression, Logistic||Model: Treatment + Site|||0.581|0.307|<0.001
71096179|NCT00309244|141701135|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.409||||0.0066|TWO_SIDED|95.0|0.215|0.78|||Regression, Logistic||Model: Treatment + Site|||0.780|0.215|0.0066
71096180|NCT00309244|141701136|SUPERIORITY_OR_OTHER|||||||0.0027|||||||Generalized Estimation Equation|Based on Poisson distribution||||||0.0027
71096181|NCT00309244|141701137|SUPERIORITY_OR_OTHER|||||||0.0591|||||||Generalized Estimating Equation|Based on Poission distribution||||||0.0591
71034575|NCT01097577|141578605|SUPERIORITY|||||||0.307|||||||t-test, 2 sided|||Days to Heal, OS||||0.307
71034576|NCT00748072|141578606|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.45||||0.01|TWO_SIDED|95.0|0.24|0.85|||Chi-squared|||The sample size was calculated by the difference in post-biopsy bleeding complications. Since the presence of bleeding was demonstrated in about 30-40 % in our previous observational study, we hypothesized a reduction risk of 0.50 and an absolute reduction of risk from 0.40 to 0.20. The sample size of the study for a power of 0.80 and a significance level \<0.05 was calculated in 158 patients.||0.85|0.24|0.01
71034577|NCT04493684|141578676|OTHER||Geometric Least Square Mean Ratio|2.462|||||TWO_SIDED|90.0|1.823|3.323|||Mixed Models Analysis|||The mixed model was used to estimate Food Effect for the log transformed parameter AUC (0-24). Analysis was performed using fed/ fasted state and tablet/ PiB as fixed effects and participant as a random effect.||3.323|1.823|
71034578|NCT04493684|141578676|OTHER||Geometric Least Square Mean Ratio|1.381|||||TWO_SIDED|90.0|1.223|1.56|||Mixed Models Analysis|||The mixed model was used to estimate Tablet vs. PiB effect for the log transformed parameter AUC (0-24). Analysis was performed using the independent variables included a fixed effect for treatment (PiB or Tablet) and period, and participant as a random effect.||1.56|1.223|
71034579|NCT04493684|141578677|OTHER||Geometric Least Square Mean Ratio|2.103|||||TWO_SIDED|90.0|1.629|2.717|||Mixed Models Analysis|||The mixed model was used to estimate Food Effect for the log transformed parameter AUC (0-inf). Analysis was performed using fed/ fasted state and tablet/ PiB as fixed effects and participant as a random effect.||2.717|1.629|
71034580|NCT04493684|141578677|OTHER||Geometric Least Square Mean Ratio|1.351|||||TWO_SIDED|90.0|1.22|1.497|||Mixed Models Analysis|||The mixed model was used to estimate Tablet vs. PiB effect for the log transformed parameter AUC (0-inf). Analysis was performed using the independent variables included a fixed effect for treatment (PiB or Tablet) and period, and participant as a random effect.||1.497|1.22|
71034581|NCT04493684|141578678|OTHER||Geometric Least Square Mean Ratio|2.307|||||TWO_SIDED|90.0|1.668|3.19|||Mixed Models Analysis|||The mixed model was used to estimate Food Effect for the log transformed parameter Cmax. Analysis was performed using fed/ fasted state and tablet/ PiB as fixed effects and participant as a random effect.||3.19|1.668|
71034582|NCT04493684|141578678|OTHER||Geometric Least Square Mean Ratio|1.372|||||TWO_SIDED|90.0|1.19|1.582|||Mixed Models Analysis|||The mixed model was used to estimate Tablet vs. PiB effect for the log transformed parameter Cmax. Analysis was performed using the independent variables included a fixed effect for treatment (PiB or Tablet) and period, and participant as a random effect.||1.582|1.19|
71034583|NCT05152576|141578745|SUPERIORITY||Rate Difference|41.4|||<|0.001|TWO_SIDED|95.0|23.5|59.3||Based on CMH test stratified by baseline investigator-rated FWS-FHL at maximum.|Cochran-Mantel-Haenszel|||Confidence interval for responder rate is calculated using normal approximation.||59.3|23.5|<0.001
70978324|NCT00348140|141464709|SUPERIORITY||Mean Difference (Net)|0.2||||0.488|TWO_SIDED|95.0|-0.4|0.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 36||0.9|-0.4|0.488
70978325|NCT00348140|141464709|SUPERIORITY||Mean Difference (Net)|0.2||||0.549|TWO_SIDED|95.0|-0.5|1.0|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 48||1.0|-0.5|0.549
70978326|NCT00348140|141464709|SUPERIORITY||Mean Difference (Net)|0.1||||0.78|TWO_SIDED|95.0|-0.6|0.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||0.9|-0.6|0.780
70978327|NCT00348140|141464710|SUPERIORITY||Mean Difference (Net)|-0.6||||0.106|TWO_SIDED|95.0|-1.3|0.1|||ANCOVA|||||0.1|-1.3|0.106
70978328|NCT00348140|141464710|SUPERIORITY||Mean Difference (Net)|-0.4||||0.229|TWO_SIDED|95.0|-1.2|0.3|||ANCOVA|||||0.3|-1.2|0.229
70978329|NCT00348140|141464711|SUPERIORITY||Mean Difference (Net)|-0.1||||0.324|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||||0.1|-0.3|0.324
70978330|NCT00348140|141464711|SUPERIORITY||Mean Difference (Net)|0.0||||0.987|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|||||0.2|-0.2|0.987
70978331|NCT00348140|141464712|SUPERIORITY||Mean Difference (Net)|0.05||||0.038|TWO_SIDED|95.0|0.0|0.1|||ANCOVA|||||0.10|0.00|0.038
71096182|NCT03019588|141701138|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.29|TWO_SIDED|95.0|0.58|1.36|||Log Rank|One-sided p-value based on log-rank test stratified by time to progression on first line therapy (\< 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by time to progression on first line therapy (\< 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).|||1.36|0.58|0.2900
71096183|NCT03019588|141701139|SUPERIORITY||Hazard Ratio (HR)|1.77||||0.9954|TWO_SIDED|95.0|1.14|2.74|||Log Rank|One-sided p-value based on log-rank test stratified by time to progression on first line therapy (\< 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by time to progression on first line therapy (\< 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).|||2.74|1.14|0.9954
71096184|NCT03019588|141701140|SUPERIORITY||Difference in percentage|-6.0||||0.7884|TWO_SIDED|95.0|-21.6|9.3|||Z-test|One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Based on Miettinen \& Nurminen method stratified by time to progression on first line therapy (\< 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).|||9.3|-21.6|0.7884
71096185|NCT00106535|141701149|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
70978332|NCT00348140|141464712|SUPERIORITY||Mean Difference (Net)|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.18|||ANCOVA|||||0.18|0.08|<0.001
70978333|NCT00348140|141464725|SUPERIORITY||Mean Difference (Net)|-0.1||||0.748|TWO_SIDED|95.0|-0.4|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8||0.3|-0.4|0.748
70978334|NCT00348140|141464725|SUPERIORITY||Mean Difference (Net)|0.1||||0.617|TWO_SIDED|95.0|-0.3|0.5|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8||0.5|-0.3|0.617
70978335|NCT00348140|141464725|SUPERIORITY||Mean Difference (Net)|-0.1||||0.708|TWO_SIDED|95.0|-0.5|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 16||0.3|-0.5|0.708
71096186|NCT00106535|141701149|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
71096187|NCT00106535|141701150|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
71096188|NCT00106535|141701150|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
70978336|NCT00348140|141464725|SUPERIORITY||Mean Difference (Net)|-0.2||||0.4|TWO_SIDED|95.0|-0.5|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 16||0.2|-0.5|0.400
70978337|NCT00348140|141464725|SUPERIORITY||Mean Difference (Net)|0.0||||0.928|TWO_SIDED|95.0|-0.4|0.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||0.4|-0.4|0.928
70978338|NCT00348140|141464725|SUPERIORITY||Mean Difference (Net)|0.3||||0.178|TWO_SIDED|95.0|-0.1|0.7|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||0.7|-0.1|0.178
70978339|NCT00348140|141464725|SUPERIORITY||Mean Difference (Net)|0.1||||0.626|TWO_SIDED|95.0|-0.3|0.5|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36||0.5|-0.3|0.626
71096189|NCT00106535|141701151|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
71096190|NCT00106535|141701151|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
71096191|NCT00106535|141701160|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's test|Stratified by region.||||||<0.0001
71096192|NCT00106535|141701160|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's test|Stratified by region.||||||<0.0001
70978340|NCT00348140|141464725|SUPERIORITY||Mean Difference (Net)|0.1||||0.608|TWO_SIDED|95.0|-0.3|0.5|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36||0.5|-0.3|0.608
70978341|NCT00348140|141464725|SUPERIORITY||Mean Difference (Net)|0.0||||0.865|TWO_SIDED|95.0|-0.5|0.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||0.4|-0.5|0.865
70978342|NCT00348140|141464725|SUPERIORITY||Mean Difference (Net)|0.3||||0.149|TWO_SIDED|95.0|-0.1|0.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||0.8|-0.1|0.149
70978343|NCT01032629|141464726|SUPERIORITY||Hazard Ratio (HR)|0.93|||=|0.4576|TWO_SIDED|95.0|0.78|1.12|||Cox proportional hazard model|||Comparison for canagliflozin versus placebo is reported here.||1.12|0.78|=0.4576
70978344|NCT01032629|141464726|SUPERIORITY||Hazard Ratio (HR)|0.83|||=|0.0467|TWO_SIDED|95.0|0.68|1.0|||Cox proportional hazard model|||Comparison for canagliflozin versus placebo is reported here.||1.00|0.68|=0.0467
70978345|NCT01032629|141464726|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.112|TWO_SIDED|95.0|0.75|1.03|||Cox proportional hazard method|||Comparison for canagliflozin versus placebo is reported here.||1.03|0.75|0.1120
70978346|NCT01032629|141464727|SUPERIORITY||Difference of Least Square Mean|2.79|STANDARD_ERROR_OF_MEAN|2.224|=|0.21|TWO_SIDED|95.0|-1.571|7.154|||ANCOVA|||Comparison for canagliflozin versus placebo is reported here.||7.154|-1.571|=0.210
70978347|NCT01032629|141464727|SUPERIORITY||Difference of Least Square Mean|4.07|STANDARD_ERROR_OF_MEAN|2.261|=|0.072|TWO_SIDED|95.0|-0.368|8.504|||ANCOVA|||Comparison for canagliflozin versus placebo is reported here.||8.504|-0.368|=0.072
70978348|NCT01032629|141464728|SUPERIORITY||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.67|0.97|||Regression, Logistic|||Comparison for canagliflozin versus placebo is reported here.||0.97|0.67|
70978349|NCT01032629|141464728|SUPERIORITY||Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.58|0.85|||Regression, Logistic|||Comparison for canagliflozin versus placebo is reported here.||0.85|0.58|
70978350|NCT01032629|141464729|OTHER||Difference of Least Square Mean|-0.03|STANDARD_ERROR_OF_MEAN|0.205|||TWO_SIDED|95.0|-0.429|0.374||||||Comparison for canagliflozin versus placebo is reported here.||0.374|-0.429|
70978351|NCT01032629|141464729|OTHER||Difference of Least Square Mean|0.33|STANDARD_ERROR_OF_MEAN|0.206|||TWO_SIDED|95.0|-0.079|0.731||||||Comparison for canagliflozin versus placebo is reported here.||0.731|-0.079|
70978352|NCT01032629|141464730|OTHER||Geometric mean ratio|0.87|||||TWO_SIDED|95.0|0.8|0.94||||||Comparison for canagliflozin versus placebo is reported here.||0.940|0.800|
70978353|NCT01032629|141464730|OTHER||Geometric mean ratio|0.84|||||TWO_SIDED|95.0|0.77|0.91||||||Comparison for canagliflozin versus placebo is reported here.||0.910|0.770|
70978354|NCT01032629|141464731|OTHER||Difference of Least Square Mean|1.68|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|95.0|0.599|2.755||||||Comparison for canagliflozin versus placebo is reported here.||2.755|0.599|
70978355|NCT01032629|141464731|OTHER||Difference of Least Square Mean|1.24|STANDARD_ERROR_OF_MEAN|0.553|||TWO_SIDED|95.0|0.16|2.328||||||Comparison for canagliflozin versus placebo is reported here.||2.328|0.160|
70978356|NCT01032629|141464732|OTHER||Difference of Least Square Mean|-0.27|STANDARD_ERROR_OF_MEAN|0.045|||TWO_SIDED|95.0|-0.355|-0.177||||||Comparison for canagliflozin versus placebo is reported here.||-0.177|-0.355|
70978357|NCT01032629|141464732|OTHER||Difference of Least Square Mean|-0.32|STANDARD_ERROR_OF_MEAN|0.046|||TWO_SIDED|95.0|-0.405|-0.227||||||Comparison for canagliflozin versus placebo is reported here.||-0.227|-0.405|
70978358|NCT01032629|141464733|OTHER||Difference of Least Square Mean|-0.58|STANDARD_ERROR_OF_MEAN|0.107|||TWO_SIDED|95.0|-0.794|-0.374||||||Comparison for canagliflozin versus placebo is reported here.||-0.374|-0.794|
70978359|NCT01032629|141464733|OTHER||Difference of Least Square Mean|-0.73|STANDARD_ERROR_OF_MEAN|0.108|||TWO_SIDED|95.0|-0.945|-0.523||||||Comparison for canagliflozin versus placebo is reported here.||-0.523|-0.945|
70978360|NCT01032629|141464734|OTHER||Difference of Least Square Mean|-2.96|STANDARD_ERROR_OF_MEAN|0.26||||95.0|-3.472|-2.454||||||Comparison for canagliflozin versus placebo is reported here.||-2.454|-3.472|
70978361|NCT01032629|141464734|OTHER||Difference of Least Square Mean|-3.61|STANDARD_ERROR_OF_MEAN|0.261|||TWO_SIDED|95.0|-4.125|-3.103||||||Comparison for canagliflozin versus placebo is reported here.||-3.103|-4.125|
71096193|NCT00106535|141701161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-70.26|||<|0.0001|TWO_SIDED|95.0|-96.96|-43.56|||ANOVA|Adjusted for region and original treatment group.||||-43.56|-96.96|<0.0001
71096194|NCT00106535|141701161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-85.95|||<|0.0001|TWO_SIDED|95.0|-112.69|-59.22|||ANOVA|Adjusted for region and original treatment group.||||-59.22|-112.69|<0.0001
71096195|NCT00106535|141701163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-148.1|||<|0.0001|TWO_SIDED|95.0|-205.22|-90.98|||ANOVA|Adjusted for region.||||-90.98|-205.22|<0.0001
71096196|NCT00106535|141701163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-181.4|||<|0.0001|TWO_SIDED|95.0|-238.6|-124.21|||ANOVA|Adjusted for region.||||-124.21|-238.60|<0.0001
71096197|NCT00106535|141701188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5212.28|||<|0.0001|TWO_SIDED|95.0|3139.4|7285.16|||ANOVA|Adjusted for region.||||7285.16|3139.40|<0.0001
70978362|NCT01032629|141464735|OTHER||Difference of Least Square Mean|-2.96|STANDARD_ERROR_OF_MEAN|0.532|||TWO_SIDED|95.0|-3.998|-1.914||||||Statistical analysis (Systolic blood pressure) Comparison for canagliflozin versus placebo is reported here.||-1.914|-3.998|
70978363|NCT01032629|141464735|OTHER||Difference of Least Square Mean|-4.53|STANDARD_ERROR_OF_MEAN|0.534|||TWO_SIDED|95.0|-5.579|-3.484||||||Statistical analysis (Systolic blood pressure) Comparison for canagliflozin versus placebo is reported here.||-3.484|-5.579|
70978364|NCT01032629|141464735|OTHER||Difference of Least Square Mean|-0.82|STANDARD_ERROR_OF_MEAN|0.314|||TWO_SIDED|95.0|-1.437|-0.205||||||Statistical analysis (Diastolic blood pressure) Comparison for canagliflozin versus placebo is reported here.||-0.205|-1.437|
70978365|NCT01032629|141464735|OTHER||Difference of Least Square Mean|-1.63|STANDARD_ERROR_OF_MEAN|0.316|||TWO_SIDED|95.0|-2.245|-1.007||||||Statistical analysis (Diastolic blood pressure) Comparison for canagliflozin versus placebo is reported here.||-1.007|-2.245|
70978366|NCT01032629|141464736|OTHER||Hodges-Lehman Estimate|0.02|||||TWO_SIDED|95.0|-0.04|0.07||||||Comparison for canagliflozin versus placebo is reported here.||0.070|-0.040|
70978367|NCT01032629|141464736|OTHER||Hodges-Lehman Estimate|0.02|||||TWO_SIDED|95.0|-0.03|0.08||||||Comparison for canagliflozin versus placebo is reported here.||0.080|-0.030|
70978368|NCT01032629|141464737|OTHER||Difference of Least Square Mean|0.18|STANDARD_ERROR_OF_MEAN|0.039|||TWO_SIDED|95.0|0.105|0.259||||||Statistical analysis (Cholesterol) Comparison for canagliflozin versus placebo is reported here.||0.259|0.105|
70978369|NCT01032629|141464737|OTHER||Difference of Least Square Mean|0.23|STANDARD_ERROR_OF_MEAN|0.039|||TWO_SIDED|95.0|0.152|0.307||||||Statistical analysis (Cholesterol) Comparison for canagliflozin versus placebo is reported here.||0.307|0.152|
70978370|NCT01032629|141464737|OTHER||Difference of Least Square Mean|0.05|STANDARD_ERROR_OF_MEAN|0.009|||TWO_SIDED|95.0|0.031|0.065||||||Statistical analysis (HDL-C)||0.065|0.031|
70978371|NCT01032629|141464737|OTHER||Difference of Least Square Mean|0.06|STANDARD_ERROR_OF_MEAN|0.009|||TWO_SIDED|95.0|0.04|0.075||||||Statistical analysis (HDL-C) Comparison for canagliflozin versus placebo is reported here.||0.075|0.040|
70978372|NCT01032629|141464737|OTHER||Difference of Least Square Mean|0.11|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|0.046|0.17||||||Statistical analysis (LDL-C) Comparison for canagliflozin versus placebo is reported here.||0.170|0.046|
70978373|NCT01032629|141464737|OTHER||Difference of Least Square Mean|0.16|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|0.102|0.226||||||Statistical analysis (LDL-C) Comparison for canagliflozin versus placebo is reported here.||0.226|0.102|
70978374|NCT01032629|141464738|OTHER||Difference of Least Square Mean|0.02|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.04|0.076||||||||0.076|-0.040|
70978375|NCT01032629|141464738|OTHER||Difference of Least Square Mean|0.04|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.023|0.094||||||||0.094|-0.023|
70978376|NCT03377634|141464751|OTHER|Analysis of covariance on change in PROMIS Pain intensity, with group as fixed effect and controlling for baseline pain intensity||||||0.11|||||||ANCOVA|||||||0.11
70978377|NCT03377634|141464752|OTHER|Analysis of covariance on change in PROMIS pain interference, with group as fixed effect and controlling for baseline pain interference||||||0.99|||||||ANCOVA|||||||.99
70978378|NCT03377634|141464753|OTHER|Analysis of covariance on change in SPPB, with group as fixed effect and controlling for baseline SPPB||||||0.14|||||||ANCOVA|||||||.14
70978379|NCT03377634|141464754|OTHER|Analysis of covariance on change in weight, with group as fixed effect and controlling for baseline weight||||||0.11|||||||ANCOVA|||||||.11
70978380|NCT03377634|141464755|OTHER|Analysis of covariance on change in activity time, with group as fixed effect and controlling for baseline stepping time||||||0.65|||||||ANCOVA|||||||.65
70978381|NCT03377634|141464756|OTHER|Analysis of covariance on change in sitting time, with group as fixed effect and controlling for baseline sitting time||||||0.41|||||||ANCOVA|||||||.41
70978382|NCT03377634|141464757|OTHER|Analysis of covariance on change in sit to stand transitions, with group as fixed effect and controlling for baseline transitions||||||0.28|||||||ANCOVA|||||||.28
70978383|NCT01818297|141464798|SUPERIORITY||Risk Difference (RD)|11.5|STANDARD_ERROR_OF_MEAN|10.5||0.14|ONE_SIDED|95.0|-5.8|||Due to early termination, the study was insufficiently powered to test the primary objective. This analysis is exploratory and descriptive in nature and cannot be considered conclusive.|Z-test|The Z-test (using an unpooled standard deviation, without continuity correction) was used to test the difference in responder rates between groups.|The Estimation Parameter is the difference between the responder rates in the Treatment and Control groups. The difference is calculated as Treatment - Control. A positive number represents a higher responder rate in the Treatment group.|The original sample size estimate for the primary objective was based on the following assumptions: 109 subjects in each arm with a responder rate of 22% in the Control group and 40% in the Treatment group, and a one-sided α= 0.05 using a Z test with unpooled variance, would result in 90% power. Because the study terminated early, the actual sample size (32 in Treatment, 30 in Control) resulted in 47% power under the same assumptions.|||-5.8|0.14
70978384|NCT03303989|141464817|SUPERIORITY|Efficacy of MMF was examined by the proportion of responders in MMF+Peg compared to PBO+Peg. Rates of the primary outcome were compared using proportions and 95% confidence intervals and tested for differences using Fisher's exact test.|||||<|0.01|TWO_SIDED|95.0|||||Fisher Exact|||Fisher's exact tests were performed to compare baseline and clinical characteristics between treatment groups as appropriate.||||<0.01
70978385|NCT01955707|141464827|SUPERIORITY_OR_OTHER||adjusted mean difference (log-scale)|0.08|||||TWO_SIDED|90.0|-0.09|0.26||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to baseline using an autoregressive variance-covariance matrix structure. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, and tissue plasminogen activator (tPA) use.||0.26|-0.09|
70978386|NCT01955707|141464827|SUPERIORITY_OR_OTHER||ratio of relative growth|1.09||||0.779|TWO_SIDED|90.0|0.91|1.3||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.|||1.30|0.91|0.779
70978387|NCT01955707|141464828|SUPERIORITY_OR_OTHER||adjusted mean difference (log-scale)|0.09|||||TWO_SIDED|90.0|-0.09|0.27||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to baseline using an autoregressive variance-covariance matrix structure. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, and tPA use.||0.27|-0.09|
70978388|NCT01955707|141464828|SUPERIORITY_OR_OTHER||ratio of relative growth|1.09||||0.797|TWO_SIDED|90.0|0.92|1.31||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.|||1.31|0.92|0.797
70978389|NCT01955707|141464829|SUPERIORITY_OR_OTHER||Adjusted mean difference (log-scale)|0.05|||||TWO_SIDED|90.0|-0.13|0.24||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to baseline using an autoregressive variance-covariance matrix structure. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, and tPA use.||0.24|-0.13|
71034584|NCT05152576|141578745|SUPERIORITY||Rate Difference|38.2|||<|0.001|TWO_SIDED|95.0|19.2|57.1||Based on CMH test stratified by baseline investigator-rated FWS-FHL at maximum.|Cochran-Mantel-Haenszel|||Confidence interval for responder rate is calculated using normal approximation.||57.1|19.2|<0.001
70978390|NCT01955707|141464829|SUPERIORITY_OR_OTHER||ratio of relative growth|1.05||||0.684|TWO_SIDED|90.0|0.88|1.27||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.|||1.27|0.88|0.684
70978391|NCT01955707|141464830|SUPERIORITY_OR_OTHER||Adjusted mean difference (log-scale)|0.0|||||TWO_SIDED|90.0|-0.12|0.11||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to 24 hours using an autoregressive variance-covariance matrix structure. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, and tPA use.||0.11|-0.12|
70978392|NCT01955707|141464830|SUPERIORITY_OR_OTHER||ratio of relative growth|1.0||||0.487|TWO_SIDED|90.0|0.89|1.12||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.|||1.12|0.89|0.487
70978393|NCT01955707|141464831|SUPERIORITY_OR_OTHER||Adjusted mean difference (log-scale)|-0.02|||||TWO_SIDED|90.0|-0.14|0.1||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to 24 hours using an autoregressive variance-covariance matrix structure. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, and tPA use.||0.10|-0.14|
70978394|NCT01955707|141464831|SUPERIORITY_OR_OTHER||ratio of relative growth|0.98||||0.402|TWO_SIDED|90.0|0.87|1.11||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.|||1.11|0.87|0.402
70978395|NCT01955707|141464832|SUPERIORITY_OR_OTHER||Adjusted mean difference (log-scale)|-0.02|||||TWO_SIDED|90.0|-0.18|0.13||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to Day 5 using an autoregressive variance-covariance matrix structure. The model adjusts for for treatment, log baseline DWI volume, treatment time window, and tPA use.||0.13|-0.18|
70978396|NCT01955707|141464832|SUPERIORITY_OR_OTHER||ratio of relative growth|0.98||||0.394|TWO_SIDED|90.0|0.84|1.14||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.|||1.14|0.84|0.394
70978397|NCT01955707|141464833|SUPERIORITY_OR_OTHER||adjusted mean change from baseline|-0.25||||0.427|TWO_SIDED|90.0|-2.48|1.98||one-sided p-value|repeated measures mixed effects model|||Analysis of NIHSS score and change from Baseline at 24 hours. The repeated measures mixed effects model is modeling absolute change in NIHSS score relative to baseline and using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, baseline NIHSS score and location of stroke.||1.98|-2.48|0.427
70978398|NCT01955707|141464833|SUPERIORITY_OR_OTHER||adjusted mean change from baseline|1.71||||0.896|TWO_SIDED|90.0|-0.52|3.94||one-sided p-value|repeated measures mixed effects model|||Analysis of NIHSS score and change from Baseline at Day 5. The repeated measures mixed effects model is modeling absolute change in NIHSS score relative to baseline and using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, baseline NIHSS score and location of stroke.||3.94|-0.52|0.896
70978399|NCT01955707|141464833|SUPERIORITY_OR_OTHER||adjusted mean change from baseline|3.15||||0.989|TWO_SIDED|90.0|0.89|5.4||one-sided p-value|repeated measures mixed effects model|||Analysis of NIHSS score and change from Baseline at Day 30. The repeated measures mixed effects model is modeling absolute change in NIHSS score relative to baseline and using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, baseline NIHSS score and location of stroke.||5.40|0.89|0.989
71034585|NCT05152576|141578745|SUPERIORITY||Rate Difference|41.4|||<|0.001|TWO_SIDED|95.0|23.5|59.3||Based on CMH test stratified by baseline investigator-rated FWS-FHL at maximum.|Cochran-Mantel-Haenszel|||Confidence interval for responder rate is calculated using normal approximation.||59.3|23.5|<0.001
71034586|NCT04115293|141578746|SUPERIORITY||LS Mean Difference|-2.09|||<|0.001|TWO_SIDED|95.0|-3.24|-0.95|||MMRM ANCOVA|||||-0.95|-3.24|<0.001
71034587|NCT04115293|141578747|SUPERIORITY||LS Mean Difference|-2.94|||<|0.001|TWO_SIDED|95.0|-4.39|-1.49|||MMRM ANCOVA|||||-1.49|-4.39|<0.001
71034588|NCT04115293|141578748|SUPERIORITY||LS Mean Difference|-3.2||||0.0023|TWO_SIDED|95.0|-5.24|-1.16|||MMRM ANCOVA|||||-1.16|-5.24|0.0023
71034589|NCT04115293|141578749|SUPERIORITY||LS Mean Difference|-2.49||||0.0128|TWO_SIDED|95.0|-4.45|-0.54|||MMRM ANCOVA|||||-0.54|-4.45|0.0128
71034590|NCT04115293|141578751|SUPERIORITY||Odds Ratio (OR)|2.608||||0.0885|TWO_SIDED|95.0|0.866|7.86|||Regression, Logistic|||||7.860|0.866|0.0885
71034591|NCT04115293|141578752|SUPERIORITY||Odds Ratio (OR)|3.184|||<|0.001|TWO_SIDED|95.0|1.662|6.101|||Regression, Logistic|||||6.101|1.662|<0.001
71034592|NCT04115293|141578753|SUPERIORITY||Odds Ratio (OR)|2.865||||0.0012|TWO_SIDED|95.0|1.518|5.409|||Regression, Logistic|||||5.409|1.518|0.0012
71034593|NCT04516434|141578820|OTHER|Descriptive analysis||||||1|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||1
71034594|NCT04516434|141578820|OTHER|Descriptive analysis||||||0.99|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||0.99
71034595|NCT04516434|141578821|OTHER|Descriptive analysis||||||0.08|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||0.08
71034596|NCT04516434|141578821|OTHER|Descriptive analysis||||||0.045|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||0.045
71034597|NCT04516434|141578823|OTHER|Descriptive analysis||||||1|||||||Mixed Models Analysis|||First sensation of bladder filling - change in cystometry before stimulation and after stimulation (up to 60 minutes).||||1
70978400|NCT01955707|141464833|SUPERIORITY_OR_OTHER||adjusted mean change from baseline|1.93||||0.915|TWO_SIDED|90.0|-0.38|4.25||one-sided p-value|repeated measures mixed effects model|||Analysis of NIHSS score and change from Baseline at Day 90. The repeated measures mixed effects model is modeling absolute change in NIHSS score relative to baseline and using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, baseline NIHSS score and location of stroke.||4.25|-0.38|0.915
70978401|NCT01955707|141464834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.564|TWO_SIDED|90.0|0.55|1.45||One sided p-value based on Van Elteren's test, adjusting for baseline DWI volume (\< median vs \>= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).|Van Elteren's test|||Analysis of distribution of mRS scores at Day 5. Odds ratio from a proportional-odds logistic regression model assuming a common odds ratio across all cut points of the mRS score. Covariates include baseline DWI volume (\< median vs \>= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).||1.45|0.55|0.564
70978402|NCT01955707|141464834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.077|TWO_SIDED|90.0|0.8|2.1||One-sided p-value based on Van Elteren's test, adjusting for baseline DWI volume (\< median vs \>= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).|Van Elteren's test|||Analysis of distribution of mRS scores at Day 30. Odds ratio from a proportional-odds logistic regression model assuming a common odds ratio across all cut points of the mRS score. Covariates include baseline DWI volume (\< median vs \>= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).||2.10|0.80|0.077
70978403|NCT01955707|141464834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.243|TWO_SIDED|90.0|0.71|1.86||One -sided p-value based on Van Elteren's test, adjusting for baseline DWI volume (\< median vs \>= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).|Van Elteren's test|||Analysis of the distribution of mRS scores at Day 90. Odds ratio from a proportional-odds logistic regression model assuming a common odds ratio across all cut points of the mRS score. Covariates include baseline DWI volume (\< median vs \>= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).||1.86|0.71|0.243
70978404|NCT01955707|141464835|SUPERIORITY_OR_OTHER||Adjusted mean|0.68||||0.455|TWO_SIDED|90.0|-9.19|10.56||one-sided p-value|repeated measures mixed effects model|||Analysis of Barthel Index at Day 5. The repeated measures mixed effects model is modeling Barthel Index using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, and location of stroke.||10.56|-9.19|0.455
70978405|NCT01955707|141464835|SUPERIORITY_OR_OTHER||Adjusted mean|1.21||||0.42|TWO_SIDED|90.0|-8.76|11.19||one-sided p-value|repeated measures mixed effects model|||Analysis of Barthel Index at Day 30. The repeated measures mixed effects model is modeling Barthel Index using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, and location of stroke.||11.19|-8.76|0.420
70978406|NCT01955707|141464835|SUPERIORITY_OR_OTHER||Adjusted mean|3.56||||0.283|TWO_SIDED|90.0|-6.64|13.75|||repeated measures mixed effects model|||Analysis of Barthel Index at Day 90/Final Visit. The repeated measures mixed effects model is modeling Barthel Index using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, and location of stroke.||13.75|-6.64|0.283
71034598|NCT04516434|141578823|OTHER|Descriptive analysis||||||0.41|||||||Mixed Models Analysis|||First sensation of bladder filling - change in cystometry before stimulation and after stimulation (up to 60 minutes).||||0.41
71034599|NCT04516434|141578823|OTHER|Descriptive analysis||||||1|||||||Mixed Models Analysis|||Maximum cystometric capacity - change in cystometry before stimulation and after stimulation (up to 60 minutes).||||1
70978407|NCT01817790|141464846|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.36||||0.0024|TWO_SIDED|95.0|-0.59|-0.13||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in Daily rTOSS between the Fluticasone nasal spray and the placebo nasal spray.||-0.13|-0.59|0.0024
70978408|NCT01817790|141464847|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.33||||0.0057|TWO_SIDED|95.0|-0.56|-0.1||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in AM rTOSS between the Fluticasone nasal spray and the placebo nasal spray.||-0.10|-0.56|0.0057
70978409|NCT01817790|141464848|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.41||||0.0009||95.0|-0.65|-0.17||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in PM rTOSS between the Fluticasone nasal spray and the placebo nasal spray.||-0.17|-0.65|0.0009
71034600|NCT04516434|141578823|OTHER|Descriptive analysis||||||0.01|||||||Mixed Models Analysis|||Maximum cystometric capacity - change in cystometry before stimulation and after stimulation (up to 60 minutes).||||0.01
71034601|NCT04516434|141578824|OTHER|Descriptive analysis||||||1|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||1
71034602|NCT04516434|141578824|OTHER|Descriptive analysis||||||1|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||1
71034603|NCT04516434|141578825|OTHER|Descriptive analysis||||||1|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||1
71034604|NCT04516434|141578825|OTHER|Descriptive analysis||||||0.99|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||0.99
71034605|NCT04278560|141578826|SUPERIORITY||Mean Difference (Net)|385.3||||0.009|TWO_SIDED|||||Repeated Measures Two-Way ANOVA: Group, Time, Group x Time, and controlled by Baseline Step Counts|ANOVA|||||||0.009
71034606|NCT04278560|141578827|SUPERIORITY||Mean Difference (Net)|1.2||||0.03|TWO_SIDED||||||ANOVA|We used change from baseline for this analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline.||||||0.03
71034607|NCT04278560|141578828|SUPERIORITY||Mean Difference (Net)|0.19||||0.4|TWO_SIDED||||||ANOVA|We used change from baseline for the analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline.||||||0.4
71096198|NCT00106535|141701188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7092.76|||<|0.0001|TWO_SIDED|95.0|5066.16|9119.36||Adjusted for region.|ANOVA|||||9119.36|5066.16|<0.0001
71096199|NCT00106535|141701204|SUPERIORITY_OR_OTHER|||||||0.0023||95.0|||||Van Elteren's test|Stratified by region.||||||0.0023
71096200|NCT00106535|141701204|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's test|||||||<0.0001
71096201|NCT00106535|141701205|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Van Elteren's test|Stratified by region.||||||0.0001
70978410|NCT01817790|141464849|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.1||||0.0117|TWO_SIDED|95.0|-0.19|-0.02||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in AM reflective symptom scores for Eye itching/burning between the Fluticasone nasal spray and the placebo nasal spray.||-0.02|-0.19|0.0117
70978411|NCT01817790|141464850|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.15||||0.0005||95.0|-0.23|-0.06||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in PM reflective symptom scores for Eye itching/burning between the Fluticasone nasal spray and the placebo nasal spray.||-0.06|-0.23|0.0005
70978412|NCT01817790|141464851|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.13||||0.0023||95.0|-0.22|-0.06||p-value was not adjusted for multiple comparisons.|ANCOVA|||Null hypothesis was that no difference exists in the mean change from baseline in AM reflective symptom scores for Eye Tearing/Watering between the Fluticasone nasal spray and the placebo nasal spray.||-0.06|-0.22|0.0023
70978413|NCT01817790|141464852|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.18|||<|0.0001||95.0|-0.26|-0.09||p-value was nor adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in PM reflective symptom scores for Eye Tearing/watering between the Fluticasone nasal spray and the placebo nasal spray.||-0.09|-0.26|<0.0001
70978414|NCT01817790|141464853|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.1||||0.0304||95.0|-0.18|-0.01||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in AM reflective symptom scores for Eye Redness between the Fluticasone nasal spray and the placebo nasal spray.||-0.01|-0.18|0.0304
70978415|NCT01817790|141464854|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.1||||0.0361||95.0|-0.19|-0.01||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in PM reflective symptom scores for Eye Redness between the Fluticasone nasal spray and the placebo nasal spray.||-0.01|-0.19|0.0361
70978416|NCT01817790|141464855|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.28||||0.0129|TWO_SIDED|95.0|-0.5|-0.06||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in AM iTOSS between the Fluticasone nasal spray and the placebo nasal spray.||-0.06|-0.50|0.0129
70978417|NCT01817790|141464856|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.14||||0.0002|TWO_SIDED|95.0|-0.22|-0.07||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in rNCSS between the Fluticasone nasal spray and the placebo nasal spray.||-0.07|-0.22|0.0002
70978418|NCT01817790|141464857|SUPERIORITY_OR_OTHER|||||||0.0118||95.0||||p-value was not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Using this test controlling for investigative site. The response variable lied on ordinal scale of measurement.||Null hypothesis was that no difference exists in the end of treatment assessment of response between the Fluticasone nasal spray and the placebo nasal spray.||||0.0118
71096202|NCT00106535|141701205|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's test|Stratified by region.||||||<0.0001
71096203|NCT01666314|141701268|SUPERIORITY_OR_OTHER|||||||0.1078|TWO_SIDED||||||Fisher Exact|||||||0.1078
71096204|NCT01666314|141701269|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.145||||0.0355|TWO_SIDED|95.0|0.9895|18.7606|||Fisher Exact||Odds ratio \>1 favors orteronel.|||18.7606|0.9895|0.0355
71096205|NCT00126737|141701295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.395||||0.0129|TWO_SIDED|95.0|-11.41|-1.38|||ANCOVA|Co-variates entered into the model were BMI and WOMAC function subscale.||||-1.38|-11.41|0.0129
71096206|NCT00126737|141701295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.174||||0.0535|TWO_SIDED|95.0|-10.43|0.079|||ANCOVA|Covariates entered into the model were BMI and WOMAC function||||0.079|-10.43|0.0535
71096207|NCT00126737|141701296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.545||||0.0307|TWO_SIDED|95.0|0.432|8.659|||ANCOVA|||||8.659|0.432|0.0307
71096208|NCT00126737|141701298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|39.94||||0.0158|TWO_SIDED|95.0|7.655|72.215|||ANCOVA|Total disease (co-morbidity) as covariate was entered into the model||||72.215|7.655|0.0158
71096209|NCT00126737|141701298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|62.25||||0.0002|TWO_SIDED|95.0|29.97|94.54|||ANCOVA|Total disease (co-morbidity) as covariate was entered into the model||||94.54|29.97|0.0002
71096210|NCT00126737|141701298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.95||||0.0056|TWO_SIDED|95.0|12.54|75.36|||ANCOVA|Total disease (co-morbidity) as covariate was entered into the model||||75.36|12.54|0.0056
71096211|NCT00126737|141701299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.129||||0.0018|TWO_SIDED|95.0|10.767|45.492|||ANCOVA|Kellgren Lawrence Scale was entered into the model||||45.492|10.767|0.0018
71096212|NCT00126737|141701299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.71||||0.0024|TWO_SIDED|95.0|9.675|43.746|||ANCOVA|Kellgren Lawrence scale was entered into the model||||43.746|9.675|0.0024
71096213|NCT00126737|141701299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.747||||0.0368|TWO_SIDED|95.0|1.169|36.325|||ANCOVA|Kellgren Lawrence Scale was entered into the model||||36.325|1.169|0.0368
70978419|NCT01817790|141464858|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.01||||0.8586|TWO_SIDED|95.0|-0.12|0.1|||ANCOVA|||Null hypothesis was that no difference exists in the mean change from baseline in objective assessment of conjunctival redness between the Fluticasone nasal spray and the placebo nasal spray.||0.10|-0.12|0.8586
70978420|NCT01817790|141464859|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.47|||<|0.0001|TWO_SIDED|95.0|-0.65|-0.29||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in MiniRQLQ scores between the Fluticasone nasal spray and the placebo nasal spray.||-0.29|-0.65|<0.0001
70978421|NCT01817790|141464860|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.49|||<|0.0001|TWO_SIDED|95.0|-0.68|-0.3||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in 'Activities' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal spray||-0.30|-0.68|<0.0001
70978422|NCT01817790|141464861|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.44|||<|0.0001|TWO_SIDED|95.0|-0.64|-0.24||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in 'Practical Problems' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal spray.||-0.24|-0.64|<0.0001
70978423|NCT01817790|141464862|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.73|-0.33||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in 'Nose Symptoms' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal spray.||-0.33|-0.73|<0.0001
70978424|NCT01817790|141464863|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.44|||<|0.0001|TWO_SIDED|95.0|-0.65|-0.23||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in 'Eye Symptoms' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal spray.||-0.23|-0.65|<0.0001
70978425|NCT01817790|141464864|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.42|||<|0.0001|TWO_SIDED|95.0|-0.64|-0.21||p-value was not adjusted for multiple comparisons.|ANCOVA|||Null hypothesis was that no difference exists in the mean change from baseline in 'Other Symptoms' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal spray.||-0.21|-0.64|<0.0001
70978426|NCT04533711|141464936|SUPERIORITY||Mean Difference (Final Values)|8.35||||0.3086|TWO_SIDED|95.0|-7.68|24.38|||Mixed Models Analysis|||||24.38|-7.68|0.3086
70978427|NCT04533711|141464937|SUPERIORITY||Mean Difference (Final Values)|10.93||||0.182|TWO_SIDED|95.0|-5.06|26.92|||Mixed Models Analysis|||||26.92|-5.06|0.1820
70978428|NCT04533711|141464938|SUPERIORITY||Mean Difference (Final Values)|308.4||||0.094|TWO_SIDED|95.0|-50.2|667.1|||Mixed Models Analysis|||||667.1|-50.2|0.094
70978429|NCT04533711|141464939|SUPERIORITY||Mean Difference (Final Values)|352.0||||0.0691|TWO_SIDED|95.0|-25.2|729.2|||Mixed Models Analysis|||||729.2|-25.2|0.0691
70978430|NCT04533711|141464940|SUPERIORITY||Mean Difference (Final Values)|-5.85||||0.4953|TWO_SIDED|95.0|-22.6|10.94|||Mixed Models Analysis|||||10.94|-22.6|0.4953
70978431|NCT04533711|141464941|SUPERIORITY||Mean Difference (Final Values)|-2.25||||0.8041|TWO_SIDED|95.0|-20.0|15.49|||Mixed Models Analysis|||||15.49|-20.0|0.8041
70978432|NCT04533711|141464942|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.9645|TWO_SIDED|95.0|-2.86|2.99|||Mixed Models Analysis|||||2.99|-2.86|0.9645
71034608|NCT04278560|141578829|SUPERIORITY||Mean Difference (Net)|3.1||||0.016|TWO_SIDED||||||ANOVA|We used change from baseline for this analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline.||||||0.016
70978433|NCT04533711|141464943|SUPERIORITY||Mean Difference (Final Values)|-2.68||||0.0989|TWO_SIDED|95.0|-5.85|0.49|||Mixed Models Analysis|||||0.49|-5.85|0.0989
71034609|NCT04278560|141578830|SUPERIORITY||Mean Difference (Net)|9.94||||0.17|TWO_SIDED||||||ANOVA|We used change from baseline for this analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline.||||||0.17
71034610|NCT04278560|141578831|SUPERIORITY||Median Difference (Net)|0.6||||0.1|TWO_SIDED||||||ANOVA|We used change from baseline for this analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline.||||||0.1
71096214|NCT00422461|141701309|SUPERIORITY||Least square (LS) mean difference|-2.8|STANDARD_ERROR_OF_MEAN|1.6||0.0822|TWO_SIDED|95.0|-5.97|0.36|||Nonlinear dose response regression model|||||0.36|-5.97|0.0822
70978434|NCT04533711|141464944|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.7667|TWO_SIDED|95.0|-0.77|1.05|||Mixed Models Analysis|||||1.05|-0.77|0.7667
70978435|NCT04533711|141464945|SUPERIORITY||Mean Difference (Final Values)|-0.87||||0.0894|TWO_SIDED|95.0|-1.87|0.13|||Mixed Models Analysis|||||0.13|-1.87|0.0894
71034611|NCT04278560|141578832|SUPERIORITY||Median Difference (Net)|0.07||||0.7|TWO_SIDED||||||ANOVA|We used change from baseline for this analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline||||||0.7
71034612|NCT04278560|141578833|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
70978436|NCT00371267|141464986|SUPERIORITY_OR_OTHER||||||<|0.27|TWO_SIDED||||||Mixed Models Analysis|||||||<0.27
70978437|NCT00371267|141464987|SUPERIORITY_OR_OTHER||||||<|0.35|TWO_SIDED||||||Mixed Models Analysis|||||||<0.35
70978438|NCT00371267|141464988|SUPERIORITY_OR_OTHER||||||<|0.74|TWO_SIDED||||||Mixed Models Analysis|||||||<0.74
70978439|NCT00371267|141464989|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Mixed Models Analysis|||||||0.39
71034613|NCT04278560|141578834|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||||||0.16
70978440|NCT00371267|141464990|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Mixed Models Analysis|||||||0.67
70978441|NCT02338843|141464991|SUPERIORITY||Odds Ratio (OR)|7.95|||<|0.001|TWO_SIDED|95.0|4.76|13.3|||Regression, Logistic|Stratified logistic regression model. Adjusted by baseline MAP and APACHE II, vasopressin use and average NED 6 hours prior to randomization.||||13.3|4.76|<0.001
70978442|NCT03804671|141465010|OTHER|Absolute bioavailability. The statistical model was an ANOVA on the logarithmic scale including the fixed effect for 'formulation' and 'subject' as a random effect.|Ratio of the geometric means (T/R) %|70.32|||||TWO_SIDED|90.0|56.69|87.23|||||The geometric coefficient of variation (gCV) = 18.7. Ratio was calculated as (AUC0-∞/dose) oral /(AUC0-∞/dose) intravenous multiplied by 100.|||87.23|56.69|
70978443|NCT03902080|141465011|SUPERIORITY||Least square mean difference|-0.74|STANDARD_ERROR_OF_MEAN|0.142|<|0.0001|TWO_SIDED|95.0|-1.02|-0.46|||Mixed Models Analysis|||||-0.46|-1.02|<0.0001
70978444|NCT03902080|141465012|SUPERIORITY||Least Squares Means Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.211|<|0.0001|TWO_SIDED|95.0|-1.37|-0.54|||Mixed Models Analysis|||||-0.54|-1.37|<0.0001
70978445|NCT03902080|141465013|SUPERIORITY||Least Squares Means Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.07|=|0.0015|TWO_SIDED|95.0|-0.36|-0.09|||Mixed Models Analysis|||||-0.09|-0.36|=0.0015
70978446|NCT03902080|141465014|SUPERIORITY||Least Squares Means Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.269|=|0.0034|TWO_SIDED|95.0|-1.33|-0.27|||Mixed Models Analysis|||||-0.27|-1.33|=0.0034
70978447|NCT03902080|141465015|SUPERIORITY||Least Squares Means Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.2|-0.5|||Mixed Models Analysis|||||-0.5|-1.2|<0.0001
70978448|NCT03902080|141465016|SUPERIORITY||Least Squares Means Difference|15.07|STANDARD_ERROR_OF_MEAN|3.03|<|0.0001|TWO_SIDED|95.0|9.13|21.02|||Mixed Models Analysis|||||21.02|9.13|<0.0001
70978449|NCT03155997|141465043|SUPERIORITY||Hazard Ratio (HR)|0.747||||0.00957|TWO_SIDED|95.0|0.598|0.932|||Log Rank|Stratified by Interactive Web Response Systems (IWRS) Geographical Region, IWRS Prior Treatment, IWRS Menopausal Status|Stratified by IWRS Geographical Region, IWRS Prior Treatment, IWRS Menopausal Status|||0.932|0.598|0.00957
70978450|NCT03155997|141465045|SUPERIORITY||Hazard Ratio (HR)|0.717|||||TWO_SIDED|95.0|0.559|0.92|||||Stratified by IWRS Geographical Region, IWRS Prior Treatment, IWRS Menopausal Status|||0.920|0.559|
70978451|NCT03093402|141465052|SUPERIORITY|The fixed effects included treatment, time, time² , time- and time² by treatment interactions. The Screening FSS score and the Screening 7-day average maximum daily pain NRS were included as covariates. Within-subject random effects for intercept and slopes for time and time² were fit using an unstructured covariance matrix, assuming a different structure for placebo and pooled active treatment groups.|Median Difference (Final Values)|-0.9||||0.419|TWO_SIDED|95.0|-2.5|0.6||This p-value is from the overall 3 degree of freedom test that simultaneously compares the estimated mean change from Day 1 to Day 84 for each of the 3 active treatment arms versus placebo.|Mixed Models Analysis||Mean difference in the change from Day 1 to Day 84 for High JBT-101 - Placebo. The estimated mean change (95% confidence interval) from Day 1 to Day 84 for Placebo was -0.3 (-1.5, 0.9).|The null hypothesis is that linear trends from Day 1 to Day 84 are equivalent for each active JBT-101 cohort and placebo. The overall test is a 3 degree of freedom F test that simultaneously compares the estimated mean change from Day 1 to Day 84 for each of the 3 active JBT-101 cohorts versus placebo.||0.6|-2.5|0.4190
71008525|NCT02140762|141525113|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|12.7|||||TWO_SIDED||||||generalized linear model.|||Vaccine effectiveness \<30% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity strains in ABCWY)/(% of not killed strains/without bactericidal activity strains in ACWY)\*100\].||||
71034614|NCT02832063|141578837|EQUIVALENCE|Primary efficacy power calculations assume a \>25% difference between B244 treatment and placebo and a 15% dropout. Each of the endpoints comprising the co-primary endpoint will be tested at an alpha level of p\<0.05. In order to achieve 90% power with a 5% Type I error rate, a total of 372 participants is required.||||||0.034|||||||ANCOVA|||||||0.034
71034615|NCT03086460|141578858|SUPERIORITY||Mean Difference (Final Values)|0.111|||<|0.001|TWO_SIDED|95.0|0.05|0.171|||ANCOVA|||"Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~The primary endpoint was analyzed using an analysis of covariance (ANCOVA) including treatment, period, and patient as fixed effects and baseline as a covariate. The confidence intervals (CIs) and the p-values of the comparisons between each dose of CHF 1531 pMDI and Placebo at Day 14 were adjusted for multiplicity, based on the parametric simulation method of Edwards and Berry."||0.171|0.050|<0.001
71034616|NCT03086460|141578858|SUPERIORITY||Mean Difference (Final Values)|0.158|||<|0.001|TWO_SIDED|95.0|0.095|0.22|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.220|0.095|<0.001
71034617|NCT03086460|141578858|SUPERIORITY||Mean Difference (Final Values)|0.133|||<|0.001|TWO_SIDED|95.0|0.072|0.194|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.194|0.072|<0.001
71034618|NCT03086460|141578858|SUPERIORITY||Mean Difference (Final Values)|0.167|||<|0.001|TWO_SIDED|95.0|0.109|0.225|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.225|0.109|<0.001
71034619|NCT03086460|141578858|SUPERIORITY||Mean Difference (Final Values)|0.144|||<|0.001|TWO_SIDED|95.0|0.098|0.19|||ANCOVA|||"Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~The statistical analysis was performed using an analysis of covariance (ANCOVA) including treatment, period, and patient as fixed effects, and baseline as a covariate."||0.190|0.098|<0.001
71096215|NCT00422461|141701309|SUPERIORITY||LS mean difference|-4.66|STANDARD_ERROR_OF_MEAN|1.92||0.017|TWO_SIDED|95.0|-8.47|-0.85|||Nonlinear dose response regression model|||||-0.85|-8.47|0.0170
70978452|NCT03093402|141465052|SUPERIORITY|The fixed effects included treatment, time, time² , time- and time² by treatment interactions. The Screening FSS score and the Screening 7-day average maximum daily pain NRS were included as covariates. Within-subject random effects for intercept and slopes for time and time² were fit using an unstructured covariance matrix, assuming a different structure for placebo and pooled active treatment groups.|Median Difference (Final Values)|-1.2||||0.419|TWO_SIDED|95.0|-2.7|0.3||This p-value is from the overall 3 degree of freedom test that simultaneously compares the estimated mean change from Day 1 to Day 84 for each of the 3 active treatment arms versus placebo.|Mixed Models Analysis||Mean difference in the change from Day 1 to Day 84 for Medium JBT-101 - Placebo. The estimated mean change (95% confidence interval) from Day 1 to Day 84 for Placebo was -0.3 (-1.5, 0.9).|The null hypothesis is that linear trends from Day 1 to Day 84 are equivalent for each active JBT-101 cohort and placebo. The overall test is a 3 degree of freedom F test that simultaneously compares the estimated mean change from Day 1 to Day 84 for each of the 3 active JBT-101 cohorts versus placebo.||0.3|-2.7|0.4190
70978453|NCT03093402|141465052|SUPERIORITY|The fixed effects included treatment, time, time² , time- and time² by treatment interactions. The Screening FSS score and the Screening 7-day average maximum daily pain NRS were included as covariates. Within-subject random effects for intercept and slopes for time and time² were fit using an unstructured covariance matrix, assuming a different structure for placebo and pooled active treatment groups.|Mean Difference (Final Values)|-0.7||||0.419|TWO_SIDED|95.0|-2.2|0.8||This p-value is from the overall 3 degree of freedom test that simultaneously compares the estimated mean change from Day 1 to Day 84 for each of the 3 active treatment arms versus placebo.|Mixed Models Analysis||Mean difference in the change from Day 1 to Day 84 for Low JBT-101 - Placebo. The estimated mean change (95% confidence interval) from Day 1 to Day 84 for Placebo was -0.3 (-1.5, 0.9).|The null hypothesis is that linear trends from Day 1 to Day 84 are equivalent for each active JBT-101 cohort and placebo. The overall test is a 3 degree of freedom F test that simultaneously compares the estimated mean change from Day 1 to Day 84 for each of the 3 active JBT-101 cohorts versus placebo.||0.8|-2.2|0.4190
70978454|NCT03093402|141465062|SUPERIORITY|||||||0.594|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each active treatment vs. placebo at Day 29.||||0.594
71034620|NCT03086460|141578858|SUPERIORITY||Mean Difference (Final Values)|0.047||||0.059|TWO_SIDED|95.0|-0.002|0.095|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~The statistical analysis was performed using an analysis of covariance (ANCOVA) including treatment, period, and patient as fixed effects, and baseline as a covariate."||0.095|-0.002|0.059
71034621|NCT03086460|141578858|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.361|TWO_SIDED|95.0|-0.026|0.07|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.070|-0.026|0.361
71034622|NCT03086460|141578858|SUPERIORITY||Mean Difference (Final Values)|0.057||||0.016|TWO_SIDED|95.0|0.011|0.102|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.102|0.011|0.016
71034623|NCT03086460|141578858|SUPERIORITY||Mean Difference (Final Values)|-0.025||||0.34|TWO_SIDED|95.0|-0.075|0.026|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.026|-0.075|0.340
71034624|NCT03086460|141578858|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.69|TWO_SIDED|95.0|-0.038|0.058|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.058|-0.038|0.690
70978455|NCT03093402|141465062|SUPERIORITY|||||||0.487|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each active treatment vs. placebo at Day 57.||||0.487
71034625|NCT03086460|141578858|SUPERIORITY||Mean Difference (Final Values)|0.034||||0.155|TWO_SIDED|95.0|-0.013|0.082|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.082|-0.013|0.155
71034626|NCT03086460|141578859|SUPERIORITY||Mean Difference (Final Values)|0.112|||<|0.001|TWO_SIDED|95.0|0.049|0.175|||ANCOVA|||"Comparison groups:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Analysis of covariance model: treatment, subject, and period as fixed effects; baseline FEV1 value as covariates. CIs and p-values for CHF 1531 pMDI vs Placebo are adjusted for multiplicity (parametric simulation method by Edwards and Berry). Subjects receiving the same treatment in more than one period are included in the primary efficacy model with only data from the first instance of each treatment."||0.175|0.049|<0.001
71034627|NCT03086460|141578859|SUPERIORITY||Mean Difference (Final Values)|0.166|||<|0.001|TWO_SIDED|95.0|0.101|0.23|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.230|0.101|<0.001
71096216|NCT00422461|141701309|SUPERIORITY||LS mean difference|-6.97|STANDARD_ERROR_OF_MEAN|2.26||0.0026|TWO_SIDED|95.0|-11.45|-2.48|||Nonlinear dose response regression model|||||-2.48|-11.45|0.0026
71096217|NCT00422461|141701310|SUPERIORITY||LS mean difference|-2.7|STANDARD_ERROR_OF_MEAN|1.2||0.0264|TWO_SIDED|95.0|-5.09|-0.32|||Nonlinear dose response regression model|||||-0.32|-5.09|0.0264
70978456|NCT03093402|141465062|SUPERIORITY|||||||0.76|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each active treatment vs. placebo at Day 85.||||0.760
70978457|NCT03093402|141465062|SUPERIORITY|||||||0.676|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each active treatment vs. placebo at Day 113.||||0.676
70978458|NCT03093402|141465063|SUPERIORITY|||||||0.796||||||This p-value is from an exact likelihood ratio test at Day 29 testing that the proportion of subjects with \>= 50% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.796
70978459|NCT03093402|141465063|SUPERIORITY|||||||0.955||||||This p-value is from an exact likelihood ratio test at Day 57 testing that the proportion of subjects with \>= 50% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.955
70978460|NCT03093402|141465063|SUPERIORITY|||||||0.211||||||This p-value is from an exact likelihood ratio test at Day 85 testing that the proportion of subjects with \>= 50% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.211
70978461|NCT03093402|141465063|SUPERIORITY|||||||0.481||||||This p-value is from an exact likelihood ratio test at Day 113 testing that the proportion of subjects with \>= 50% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.481
70978462|NCT03093402|141465064|SUPERIORITY|||||||0.79||||||This p-value is from an exact likelihood ratio test at Day 29 testing that the proportion of subjects with \>= 75% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.790
70978463|NCT03093402|141465064|SUPERIORITY|||||||0.843||||||This p-value is from an exact likelihood ratio test at Day 57 testing that the proportion of subjects with \>= 75% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.843
70978464|NCT03093402|141465064|SUPERIORITY|||||||0.637||||||This p-value is from an exact likelihood ratio test at Day 85 testing that the proportion of subjects with \>= 75% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.637
70978465|NCT03093402|141465064|SUPERIORITY|||||||0.243||||||This p-value is from an exact likelihood ratio test at Day 113 testing that the proportion of subjects with \>= 75% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.243
70978466|NCT03093402|141465065|SUPERIORITY||||||>|0.999||||||This p-value is from an exact likelihood ratio test at Day 57 testing that the proportion of subjects with \>=100% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebo||||>0.999
70978467|NCT03093402|141465065|SUPERIORITY|||||||0.861||||||This p-value is from an exact likelihood ratio test at Day 85 testing that the proportion of subjects with \>= 100% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebo||||0.861
70978468|NCT03093402|141465066|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.39|TWO_SIDED|95.0|-4.8|8.7||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline tender joint count at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline tender joint count for High JBT-101 - Placebo. The estimated tender joint count mean change from baseline (95% confidence interval) for Placebo was -6.3 (-12.0, -0.7).|Each active JBT-101 cohort is compared to placebo.||8.7|-4.8|0.390
70978469|NCT03093402|141465066|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.39|TWO_SIDED|95.0|-4.9|8.2||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline tender joint count at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline tender joint count for Medium JBT-101 - Placebo. The estimated tender joint count mean change from baseline (95% confidence interval) for Placebo was -6.3 (-12.0, -0.7).|Each active JBT-101 cohort is compared to placebo.||8.2|-4.9|0.390
70978470|NCT03093402|141465066|SUPERIORITY||Median Difference (Final Values)|-2.0||||0.39|TWO_SIDED|95.0|-8.6|4.6||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline tender joint count at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline tender joint count for Low JBT-101 - Placebo. The estimated tender joint count mean change from baseline (95% confidence interval) for Placebo was -6.3 (-12.0, -0.7).|Each active JBT-101 cohort is compared to placebo.||4.6|-8.6|0.390
70978471|NCT03093402|141465067|SUPERIORITY||Median Difference (Final Values)|0.7||||0.556|TWO_SIDED|95.0|-1.6|3.0||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline swollen joint count at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline swollen joint count for High JBT-101 - Placebo. The estimated swollen joint count mean change from baseline (95% confidence interval) for Placebo was -4.0 (-5.7, -2.4).|Each active JBT-101 cohort is compared to placebo.||3.0|-1.6|0.556
70978472|NCT03093402|141465067|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.556|TWO_SIDED|95.0|-2.5|2.0||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline swollen joint count at Day 85 for each JBT-101 cohort versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline swollen joint count for Medium JBT-101 - Placebo. The estimated swollen joint count mean change from baseline (95% confidence interval) for Placebo was -4.0 (-5.7, -2.4).|Each active JBT-101 cohort is compared to placebo.||2.0|-2.5|0.556
70978473|NCT03093402|141465067|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.556|TWO_SIDED|95.0|-3.1|1.4||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline swollen joint count at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline swollen joint count for High JBT-101 - Placebo. The estimated swollen joint count mean change from baseline (95% confidence interval) for Placebo was -4.0 (-5.7, -2.4).|Each active JBT-101 cohort is compared to placebo.||1.4|-3.1|0.556
71096218|NCT00422461|141701310|SUPERIORITY||LS mean difference|-4.56|STANDARD_ERROR_OF_MEAN|1.41||0.0016|TWO_SIDED|95.0|-7.35|-1.77|||Nonlinear dose response regression model|||||-1.77|-7.35|0.0016
71096219|NCT00422461|141701310|SUPERIORITY||LS mean difference|-6.96|STANDARD_ERROR_OF_MEAN|1.55|<|0.0001|TWO_SIDED|95.0|-10.03|-3.89|||Nonlinear dose response regression model|||||-3.89|-10.03|<0.0001
71096220|NCT00422461|141701311|SUPERIORITY||LS mean difference|0.13|STANDARD_ERROR_OF_MEAN|1.98||0.9479|TWO_SIDED|95.0|-3.79|4.05|||ANCOVA|||For SBP||4.05|-3.79|0.9479
71096221|NCT00422461|141701311|SUPERIORITY||LS mean difference|-4.75|STANDARD_ERROR_OF_MEAN|2.03||0.0215|TWO_SIDED|95.0|-8.78|-0.72|||ANCOVA|||For SBP||-0.72|-8.78|0.0215
71034628|NCT03086460|141578859|SUPERIORITY||Mean Difference (Final Values)|0.138|||<|0.001|TWO_SIDED|95.0|0.074|0.203|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.203|0.074|<0.001
71034629|NCT03086460|141578859|SUPERIORITY||Mean Difference (Final Values)|0.174|||<|0.001|TWO_SIDED|95.0|0.113|0.235|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.235|0.113|<0.001
71034630|NCT03086460|141578859|SUPERIORITY||Mean Difference (Final Values)|0.149|||<|0.001|TWO_SIDED|95.0|0.101|0.197|||ANCOVA|||"Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Analysis of covariance model: treatment, subject, and period as fixed effects; baseline FEV1 value as covariates. Subjects receiving the same treatment in more than one period are included in the primary efficacy model with only data from the first instance of each treatment."||0.197|0.101|<0.001
71034631|NCT03086460|141578859|SUPERIORITY||Mean Difference (Final Values)|0.054||||0.035|TWO_SIDED|95.0|0.004|0.104|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Analysis of covariance model: treatment, subject, and period as fixed effects; baseline FEV1 value as covariates. Subjects receiving the same treatment in more than one period are included in the primary efficacy model with only data from the first instance of each treatment."||0.104|0.004|0.035
71034632|NCT03086460|141578859|SUPERIORITY||Mean Difference (Final Values)|0.026||||0.301|TWO_SIDED|95.0|-0.024|0.076|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.076|-0.024|0.301
71034633|NCT03086460|141578859|SUPERIORITY||Mean Difference (Final Values)|0.062||||0.011|TWO_SIDED|95.0|0.014|0.11|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.110|0.014|0.011
71034634|NCT03086460|141578859|SUPERIORITY||Mean Difference (Final Values)|-0.028||||0.294|TWO_SIDED|95.0|-0.08|0.024|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.024|-0.080|0.294
71034635|NCT03086460|141578859|SUPERIORITY||Mean Difference (Final Values)|0.008||||0.747|TWO_SIDED|95.0|-0.042|0.058|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.058|-0.042|0.747
71096222|NCT00422461|141701311|SUPERIORITY||LS mean difference|-3.43|STANDARD_ERROR_OF_MEAN|2.0||0.0886|TWO_SIDED|95.0|-7.39|0.53|||ANCOVA|||For SBP||0.53|-7.39|0.0886
71034636|NCT03086460|141578859|SUPERIORITY||Mean Difference (Final Values)|0.036||||0.155|TWO_SIDED|95.0|-0.014|0.086|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.086|-0.014|0.155
71034637|NCT03086460|141578860|SUPERIORITY||Mean Difference (Final Values)|0.136|||<|0.001|TWO_SIDED|95.0|0.065|0.207|||ANCOVA|||"Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Analysis of covariance model: treatment, subject, and period as fixed effects; baseline FEV1 value as covariates. CIs and p-values for CHF 1531 pMDI vs Placebo are adjusted for multiplicity (parametric simulation method by Edwards and Berry). Subjects receiving the same treatment in more than one period are included in the model with only data for the instance of each treatment, which occurred after the randomization error."||0.207|0.065|<0.001
71096223|NCT00422461|141701311|SUPERIORITY||LS mean difference|-1.45|STANDARD_ERROR_OF_MEAN|1.44||0.3173|TWO_SIDED|95.0|-4.3|1.41|||ANCOVA|||For DBP||1.41|-4.30|0.3173
71096224|NCT00422461|141701311|SUPERIORITY||LS mean difference|-3.81|STANDARD_ERROR_OF_MEAN|1.42||0.0087|TWO_SIDED|95.0|-6.64|-0.99|||ANCOVA|||For DBP||-0.99|-6.64|0.0087
71096225|NCT00422461|141701311|SUPERIORITY||LS mean difference|-3.95|STANDARD_ERROR_OF_MEAN|1.41||0.0062|TWO_SIDED|95.0|-6.76|-1.15|||ANCOVA|||For DBP||-1.15|-6.76|0.0062
71034638|NCT03086460|141578860|SUPERIORITY||Mean Difference (Final Values)|0.186|||<|0.001|TWO_SIDED|95.0|0.113|0.258|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.258|0.113|<0.001
71096226|NCT00422461|141701313|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|2.48||0.8091|TWO_SIDED|95.0|-5.51|4.31|||ANCOVA|||For cuff SBP||4.31|-5.51|0.8091
71096227|NCT00422461|141701313|SUPERIORITY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|2.44||0.8809|TWO_SIDED|95.0|-5.21|4.48|||ANCOVA|||For cuff SBP||4.48|-5.21|0.8809
71096228|NCT00422461|141701313|SUPERIORITY||LS mean difference|-5.16|STANDARD_ERROR_OF_MEAN|2.46||0.0382|TWO_SIDED|95.0|-10.04|-0.29|||ANCOVA|||For cuff SBP||-0.29|-10.04|0.0382
71096229|NCT00422461|141701313|SUPERIORITY||LS mean difference|-3.03|STANDARD_ERROR_OF_MEAN|1.67||0.0731|TWO_SIDED|95.0|-6.35|0.29|||ANCOVA|||For cuff DBP||0.29|-6.35|0.0731
71096230|NCT00422461|141701313|SUPERIORITY||LS mean difference|-4.49|STANDARD_ERROR_OF_MEAN|1.65||0.0077|TWO_SIDED|95.0|-7.77|-1.22|||ANCOVA|||For cuff DBP||-1.22|-7.77|0.0077
71096231|NCT00422461|141701313|SUPERIORITY||LS mean difference|-4.29|STANDARD_ERROR_OF_MEAN|1.66||0.0111|TWO_SIDED|95.0|-7.58|-1.0|||ANCOVA|||For cuff DBP||-1.00|-7.58|0.0111
70978474|NCT03093402|141465068|SUPERIORITY|||||||0.669|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 29.||||0.669
70978475|NCT03093402|141465068|SUPERIORITY|||||||0.432|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 57.||||0.432
70978476|NCT03093402|141465068|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 85.||||0.780
70978477|NCT03093402|141465068|SUPERIORITY|||||||0.285|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 113.||||0.285
70978478|NCT03093402|141465070|SUPERIORITY|The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 29.||||||0.872|||||||Mixed Models Analysis|||JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebo||||0.872
70978479|NCT03093402|141465070|SUPERIORITY|The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 57.||||||0.895|||||||Mixed Models Analysis|||JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebo||||0.895
71034639|NCT03086460|141578860|SUPERIORITY||Mean Difference (Final Values)|0.165|||<|0.001|TWO_SIDED|95.0|0.092|0.238|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.238|0.092|<0.001
71034640|NCT03086460|141578860|SUPERIORITY||Mean Difference (Final Values)|0.185|||<|0.001|TWO_SIDED|95.0|0.118|0.252|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.252|0.118|<0.001
71034641|NCT03086460|141578860|SUPERIORITY||Mean Difference (Final Values)|0.176|||<|0.001|TWO_SIDED|95.0|0.121|0.231|||ANCOVA|||"Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Analysis of covariance model: treatment, subject, and period as fixed effects; baseline FEV1 value as covariates. Subjects receiving the same treatment in more than one period are included in the model with only data for the instance of each treatment which occurred after the randomization error."||0.231|0.121|<0.001
71034642|NCT03086460|141578860|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.088|TWO_SIDED|95.0|-0.008|0.108|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Analysis of covariance model: treatment, subject, and period as fixed effects; baseline FEV1 value as covariates. Subjects receiving the same treatment in more than one period are included in the model with only data for the instance of each treatment which occurred after the randomization error."||0.108|-0.008|0.088
71034643|NCT03086460|141578860|SUPERIORITY||Mean Difference (Final Values)|0.029||||0.323|TWO_SIDED|95.0|-0.029|0.088|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.088|-0.029|0.323
71034644|NCT03086460|141578860|SUPERIORITY||Mean Difference (Final Values)|0.049||||0.073|TWO_SIDED|95.0|-0.005|0.103|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.103|-0.005|0.073
71034645|NCT03086460|141578860|SUPERIORITY||Mean Difference (Final Values)|-0.021||||0.489|TWO_SIDED|95.0|-0.08|0.039|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.039|-0.080|0.489
71034646|NCT03086460|141578860|SUPERIORITY||Median Difference (Final Values)|-0.001||||0.978|TWO_SIDED|95.0|-0.057|0.056|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.056|-0.057|0.978
71034647|NCT03086460|141578860|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.484|TWO_SIDED|95.0|-0.037|0.077|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.077|-0.037|0.484
71034648|NCT03086460|141578861|SUPERIORITY||Mean Difference (Final Values)|0.107|||<|0.001|TWO_SIDED|95.0|0.048|0.166|||ANCOVA|||"Comparison groups:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Analysis of covariance model: treatment and period as fixed effects, subject as random effect, baseline FEV1 value as covariate. CIs and p-values for CHF 1531 pMDI vs Placebo are adjusted for multiplicity (parametric simulation method by Edwards and Berry). Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended)."||0.166|0.048|<0.001
71096232|NCT00422461|141701315|SUPERIORITY||LS mean difference|-1.94|STANDARD_ERROR_OF_MEAN|1.7||0.2567|TWO_SIDED|95.0|-5.32|1.44|||ANCOVA|||||1.44|-5.32|0.2567
71034649|NCT03086460|141578861|SUPERIORITY||Mean Difference (Final Values)|0.157|||<|0.001|TWO_SIDED|95.0|0.096|0.217|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.217|0.096|<0.001
70978480|NCT03093402|141465070|SUPERIORITY|The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 85.||||||0.669|||||||Mixed Models Analysis|||JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebo||||0.669
70978481|NCT03093402|141465070|SUPERIORITY|The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 113.||||||0.668|||||||Mixed Models Analysis|||JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebo||||0.668
70978482|NCT03093402|141465071|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.82|TWO_SIDED|95.0|-2.3|1.5||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline SELENA-SLEDAI Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline SLEDAI score for High JBT-101 - Placebo. The estimated Day 85 SLEDAI mean change from baseline (95% confidence interval) for Placebo was -2.2 (-3.6, -0.8).|Each active JBT-101 cohort is compared to placebo.||1.5|-2.3|.820
70978483|NCT03093402|141465071|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.82|TWO_SIDED|95.0|-2.0|1.8||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline SELENA-SLEDAI Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline SLEDAI score for Medium JBT-101 - Placebo. The estimated Day 85 SLEDAI mean change from baseline (95% confidence interval) for Placebo was -2.2 (-3.6, -0.8).|Each active JBT-101 cohort is compared to placebo.||1.8|-2.0|.820
70978484|NCT03093402|141465071|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.82|TWO_SIDED|95.0|-2.6|1.1||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline SELENA-SLEDAI Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline SLEDAI score for Low JBT-101 - Placebo. The estimated Day 85 SLEDAI mean change from baseline (95% confidence interval) for Placebo was -2.2 (-3.6, -0.8).|Each active JBT-101 cohort is compared to placebo.||1.1|-2.6|.820
70978485|NCT03093402|141465072|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.244|TWO_SIDED|95.0|-3.0|4.4||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline BILAG total score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline BILAG score for High JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -4.3 (-7.0, -1.5).|Each active JBT-101 cohort is compared to placebo.||4.4|-3.0|.244
70978486|NCT03093402|141465072|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.244|TWO_SIDED|95.0|-5.2|2.0||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline BILAG total score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline BILAG score for Medium JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -4.3 (-7.0, -1.5).|Each active JBT-101 cohort is compared to placebo.||2.0|-5.2|.244
71034650|NCT03086460|141578861|SUPERIORITY||Mean Difference (Final Values)|0.133|||<|0.001|TWO_SIDED|95.0|0.073|0.193|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.193|0.073|<0.001
71034651|NCT03086460|141578861|SUPERIORITY||Mean Difference (Final Values)|0.16|||<|0.001|TWO_SIDED|95.0|0.103|0.217|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.217|0.103|<0.001
71034652|NCT03086460|141578861|SUPERIORITY||Mean Difference (Final Values)|0.147|||<|0.001|TWO_SIDED|95.0|0.102|0.192|||ANCOVA|||"Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Analysis of covariance model: treatment and period as fixed effects, subject as random effect, baseline FEV1 value as covariate. Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended)."||0.192|0.102|<0.001
71034653|NCT03086460|141578861|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.041|TWO_SIDED|95.0|0.002|0.098|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Analysis of covariance model: treatment and period as fixed effects, subject as random effect, baseline FEV1 value as covariate. Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended)."||0.098|0.002|0.041
71034654|NCT03086460|141578861|SUPERIORITY||Mean Difference (Final Values)|0.026||||0.275|TWO_SIDED|95.0|-0.021|0.073|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.073|-0.021|0.275
71034655|NCT03086460|141578861|SUPERIORITY||Mean Difference (Final Values)|0.053||||0.021|TWO_SIDED|95.0|0.008|0.098|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.098|0.008|0.021
71034656|NCT03086460|141578861|SUPERIORITY||Mean Difference (Final Values)|-0.024||||0.35|TWO_SIDED|95.0|-0.073|0.026|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.026|-0.073|0.350
71096233|NCT00422461|141701315|SUPERIORITY||LS mean difference|-2.94|STANDARD_ERROR_OF_MEAN|1.69||0.086|TWO_SIDED|95.0|-6.29|0.42|||ANCOVA|||||0.42|-6.29|0.0860
70978487|NCT03093402|141465072|SUPERIORITY||Median Difference (Final Values)|-2.6||||0.244|TWO_SIDED|95.0|-6.2|0.9||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline BILAG total score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline BILAG score for Low JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -4.3 (-7.0, -1.5).|Each active JBT-101 cohort is compared to placebo.||0.9|-6.2|.244
70978488|NCT03093402|141465073|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.408|TWO_SIDED|95.0|-0.27|0.4||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Physician's Global Assessment (PGA) Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline PGA score for High JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -0.43 (-0.70, -0.15).|Each active JBT-101 cohort is compared to placebo.||0.40|-0.27|0.408
70978489|NCT03093402|141465073|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.408|TWO_SIDED|95.0|-0.4|0.26||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Physician's Global Assessment (PGA) Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline PGA score for High JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -0.43 (-0.70, -0.15).|Each active JBT-101 cohort is compared to placebo.||0.26|-0.40|0.408
70978490|NCT03093402|141465073|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.408|TWO_SIDED|95.0|-0.5|0.16||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Physician's Global Assessment (PGA) Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline PGA score for Low JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -0.43 (-0.70, -0.15).|Each active JBT-101 cohort is compared to placebo.||0.16|-0.50|0.408
70978491|NCT03093402|141465074|SUPERIORITY||Mean Difference (Final Values)|-21.48||||0.07|TWO_SIDED|95.0|-37.24|-5.72||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Patient Global Assessment Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline Patient Global Assessment score for High JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -5.27 (-16.11, 5.56).|Each active JBT-101 cohort is compared to placebo.||-5.72|-37.24|0.070
70978492|NCT03093402|141465074|SUPERIORITY||Mean Difference (Final Values)|-10.4||||0.07|TWO_SIDED|95.0|-25.33|4.54||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Patient Global Assessment Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline Patient Global Assessment score for High JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -5.27 (-16.11, 5.56).|Each active JBT-101 cohort is compared to placebo.||4.54|-25.33|0.070
70978493|NCT03093402|141465074|SUPERIORITY||Mean Difference (Final Values)|-10.81||||0.07|TWO_SIDED|95.0|-25.78|4.16||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Patient Global Assessment Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline Patient Global Assessment score for Low JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -5.27 (-16.11, 5.56).|Each active JBT-101 cohort is compared to placebo.||4.16|-25.78|0.070
70978494|NCT03093402|141465075|SUPERIORITY||Median Difference (Final Values)|0.3||||0.979|TWO_SIDED|95.0|-3.38|3.99||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Physical Function T-score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 1.8 (-0.8, 4.3).|||3.99|-3.38|0.979
71008753|NCT02055976|141525250|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.369|STANDARD_ERROR_OF_MEAN|9.58||0.515|TWO_SIDED|95.0|-18.668|19.407|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||19.407|-18.668|0.515
71008754|NCT02055976|141525250|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-10.056|STANDARD_ERROR_OF_MEAN|8.801||0.128|TWO_SIDED|95.0|-27.549|7.437|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.437|-27.549|0.128
71008755|NCT02055976|141525250|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-24.352|STANDARD_ERROR_OF_MEAN|8.882||0.004|TWO_SIDED|95.0|-42.008|-6.695|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-6.695|-42.008|0.004
71008756|NCT02055976|141525250|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-14.994|STANDARD_ERROR_OF_MEAN|8.987||0.049|TWO_SIDED|95.0|-32.858|2.87|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||2.870|-32.858|0.049
71096234|NCT00422461|141701315|SUPERIORITY||LS mean difference|-4.46|STANDARD_ERROR_OF_MEAN|1.71||0.0103|TWO_SIDED|95.0|-7.85|-1.08|||ANCOVA|||||-1.08|-7.85|0.0103
70978495|NCT03093402|141465075|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.979|TWO_SIDED|95.0|-3.13|3.93||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Physical Function T-score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 1.8 (-0.8, 4.3).|||3.93|-3.13|0.979
70978496|NCT03093402|141465075|SUPERIORITY||Median Difference (Final Values)|0.77||||0.979|TWO_SIDED|95.0|-2.77|4.31||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Physical Function Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was 1.8 (-0.8, 4.3).|||4.31|-2.77|0.979
71034657|NCT03086460|141578861|SUPERIORITY||Mean Difference (Final Values)|0.003||||0.886|TWO_SIDED|95.0|-0.044|0.051|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.051|-0.044|0.886
71096235|NCT03593629|141701326|NON_INFERIORITY|Non-inferiority margin was defined as -10%|Risk Difference (RD)|2.37|||||ONE_SIDED|95.0|-5.05||||||||||-5.05|
70922471|NCT02376790|141336004|SUPERIORITY||Treatment Difference|13.4|||<|0.001|TWO_SIDED|95.0|6.5|20.4||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of the percentage of participants with an ACR70 response at week 24.||20.4|6.5|<0.001
70978497|NCT03093402|141465076|SUPERIORITY||Mean Difference (Final Values)|-1.44||||0.788|TWO_SIDED|95.0|-6.14|3.26||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Anxiety T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -1.8 (-4.8, 1.2).|||3.26|-6.14|0.788
71096236|NCT03593629|141701327|NON_INFERIORITY|non-inferiority margin is defined as -10%|Risk Difference (RD)|-2.6|||||ONE_SIDED|95.0|-8.88||||||||||-8.88|
71096237|NCT03593629|141701328|NON_INFERIORITY|non-inferiority margin is defined as -10%|Risk Difference (RD)|-1.15|||||ONE_SIDED|95.0|-6.89||||||||||-6.89|
71096238|NCT01160744|141701390|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.1318|TWO_SIDED|90.0|0.55|1.03|||Log Rank|||||1.03|0.55|0.1318
71096239|NCT01160744|141701390|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.5215|TWO_SIDED|90.0|0.64|1.22|||Log Rank|||||1.22|0.64|0.5215
70922472|NCT02376790|141336004|SUPERIORITY||Treatment Difference|13.7|||<|0.001|TWO_SIDED|95.0|6.7|20.7||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of the percentage of participants with an ACR70 response at week 24.||20.7|6.7|<0.001
70922473|NCT02376790|141336013|SUPERIORITY||LS Mean Treatment Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.91|-0.34||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in PASDAS at week 24||-0.34|-0.91|<0.001
70922474|NCT02376790|141336013|SUPERIORITY||LS Mean Treatment Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.92|-0.34||P-value is unadjusted and considered descriptive|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in PASDAS at week 24||-0.34|-0.92|<0.001
70922475|NCT02376790|141336014|SUPERIORITY||LS Mean Treatment Difference|-0.63|STANDARD_ERROR_OF_MEAN|1.18||0.59|TWO_SIDED|95.0|-2.93|1.68||P-value is unadjusted and considered descriptive|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in CDAI at week 24||1.68|-2.93|0.59
70922476|NCT02376790|141336014|SUPERIORITY||LS Mean Treatment Difference|-1.32|STANDARD_ERROR_OF_MEAN|1.18||0.26|TWO_SIDED|95.0|-3.63|0.99||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in CDAI at week 24||0.99|-3.63|0.26
70922477|NCT02376790|141336015|SUPERIORITY||LS Mean Treatment Difference|-0.98|STANDARD_ERROR_OF_MEAN|1.2||0.41|TWO_SIDED|95.0|-3.35|1.38||P-value is unadjusted and considered descriptive|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in SDAI at week 24||1.38|-3.35|0.41
70922478|NCT02376790|141336015|SUPERIORITY||LS Mean Treatment Difference|-1.72|STANDARD_ERROR_OF_MEAN|1.21||0.15|TWO_SIDED|95.0|-4.09|0.65||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in SDAI at week 24||0.65|-4.09|0.15
70922479|NCT02376790|141336016|SUPERIORITY||LS Mean Treatment Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.11||0.01|TWO_SIDED|95.0|-0.52|-0.07||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in DAS28 at week 24||-0.07|-0.52|0.010
70922480|NCT02376790|141336016|SUPERIORITY||LS Mean Treatment Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.62|-0.17||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in DAS28 at week 24||-0.17|-0.62|<0.001
70978498|NCT03093402|141465076|SUPERIORITY||Mean Difference (Final Values)|-1.56||||0.788|TWO_SIDED|95.0|-6.07|2.96||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Anxiety T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -1.8 (-4.8, 1.2).|||2.96|-6.07|0.788
70978499|NCT03093402|141465076|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.788|TWO_SIDED|95.0|-4.0|4.94||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Anxiety T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -1.8 (-4.8, 1.2).|||4.94|-4.00|0.788
70978500|NCT03093402|141465077|SUPERIORITY||Mean Difference (Final Values)|-1.49||||0.766|TWO_SIDED|95.0|-6.14|3.16||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Depression T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -1.7(-4.6, 1.3).|||3.16|-6.14|0.766
71096240|NCT01160744|141701391|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.58||||0.1797|TWO_SIDED|90.0|0.9|2.78|||Chi-squared|||||2.78|0.90|0.1797
70978501|NCT03093402|141465077|SUPERIORITY||Mean Difference (Final Values)|0.76||||0.766|TWO_SIDED|95.0|-3.6|5.11||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Depression T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -1.7(-4.6, 1.3).|||5.11|-3.60|0.766
71034658|NCT03086460|141578861|SUPERIORITY||Mean Difference (Final Values)|0.027||||0.254|TWO_SIDED|95.0|-0.02|0.074|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.074|-0.020|0.254
71034659|NCT03086460|141578862|SUPERIORITY||Mean Difference (Final Values)|0.114|||<|0.001|TWO_SIDED|95.0|0.06|0.169|||ANCOVA|||"Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.169|0.060|<0.001
71034660|NCT03086460|141578862|SUPERIORITY||Mean Difference (Final Values)|0.154|||<|0.001|TWO_SIDED|95.0|0.099|0.208|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.208|0.099|<0.001
71034661|NCT03086460|141578862|SUPERIORITY||Mean Difference (Final Values)|0.193|||<|0.001|TWO_SIDED|95.0|0.138|0.247|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.247|0.138|<0.001
70978502|NCT03093402|141465077|SUPERIORITY||Mean Difference (Final Values)|-1.24||||0.766|TWO_SIDED|95.0|-5.55|3.07||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Depression T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -1.7(-4.6, 1.3).|||3.07|-5.55|0.766
70978503|NCT03093402|141465078|SUPERIORITY||Mean Difference (Final Values)|-0.44||||0.982|TWO_SIDED|95.0|-6.04|5.17||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Fatigue T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -4.7 (-8.3, -1.1).|||5.17|-6.04|0.982
70978504|NCT03093402|141465078|SUPERIORITY||Mean Difference (Final Values)|-0.86||||0.982|TWO_SIDED|95.0|-6.22|4.5||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Fatigue T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -4.7 (-8.3, -1.1).|Each active JBT-101 cohort is compared to placebo.||4.50|-6.22|0.982
71034662|NCT03086460|141578862|SUPERIORITY||Mean Difference (Final Values)|0.216|||<|0.001|TWO_SIDED|95.0|0.163|0.268|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.268|0.163|<0.001
71034663|NCT03086460|141578862|SUPERIORITY||Mean Difference (Final Values)|0.172|||<|0.001|TWO_SIDED|95.0|0.12|0.224|||ANCOVA|||"Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.224|0.120|<0.001
71034664|NCT03086460|141578862|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.165|TWO_SIDED|95.0|-0.016|0.095|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.095|-0.016|0.165
71096241|NCT01160744|141701391|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.66||||0.007|TWO_SIDED|90.0|1.45|4.86|||Chi-squared|||||4.86|1.45|0.0070
71096242|NCT01160744|141701392|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.03||||0.8916|TWO_SIDED|90.0|0.74|1.42|||Log Rank|||||1.42|0.74|0.8916
71096243|NCT01160744|141701392|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.6847|TWO_SIDED|90.0|0.68|1.27|||Log Rank|||||1.27|0.68|0.6847
71096244|NCT01160744|141701395|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.48||||0.0316|TWO_SIDED|90.0|1.22|5.02|||Chi-squared|||||5.02|1.22|0.0316
71096245|NCT01160744|141701395|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.3962|TWO_SIDED|90.0|0.74|2.52|||Chi-squared|||||2.52|0.74|0.3962
71096246|NCT01160744|141701396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1571|TWO_SIDED||||||t-test, 2 sided|||||||0.1571
71096247|NCT01160744|141701396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1597|TWO_SIDED||||||t-test, 2 sided|||||||0.1597
71096248|NCT04676646|141701408|SUPERIORITY||Odds Ratio (OR)|4.45|||<|0.001|TWO_SIDED|95.0|2.89|6.86|||GEE model||An odds ratio greater than 1 indicated increased odds of response on SZC compared to placebo.|||6.86|2.89|<0.001
71096249|NCT04676646|141701409|SUPERIORITY||Odds Ratio (OR)|4.58|||<|0.001|TWO_SIDED|95.0|2.78|7.55|||GEE model||An odds ratio \>1 indicated increased odds of response on SZC compared to placebo.|||7.55|2.78|<0.001
71096250|NCT04676646|141701410|SUPERIORITY||Odds Ratio (OR)|4.33|||<|0.001|TWO_SIDED|95.0|2.5|7.52|||GEE model||An odds ratio greater than 1 indicated increased odds of response on SZC compared to placebo.|||7.52|2.50|<0.001
71096251|NCT04676646|141701411|SUPERIORITY||Hazard Ratio (HR)|0.51|||<|0.001||95.0|0.37|0.71|||Regression, Cox||A hazard ratio less than 1 favors SZC to be associated with a longer time to first hyperkalaemia episode than placebo.|||0.71|0.37|<0.001
71096252|NCT04676646|141701412|SUPERIORITY||Hazard Ratio (HR)|0.37||||0.006|TWO_SIDED|95.0|0.17|0.73|||Regression, Cox||A hazard ratio less than 1 favored SZC to be associated with a longer time to first instance of a decrease of spironolactone dose due to hyperkalaemia than placebo.|||0.73|0.17|0.006
71096253|NCT04676646|141701413|SUPERIORITY||Least-squares Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|2.84||0.724|TWO_SIDED|95.0|-6.64|4.63|||t-test, 2 sided||A least-squares mean difference greater than 0 favors SZC compared to placebo.|||4.63|-6.64|0.724
70978505|NCT03093402|141465078|SUPERIORITY||Mean Difference (Final Values)|-0.98||||0.982|TWO_SIDED|95.0|-6.32|4.36||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Fatigue T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -4.7 (-8.3, -1.1).|||4.36|-6.32|0.982
70978506|NCT03093402|141465079|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.607|TWO_SIDED|95.0|-4.74|4.91||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Sleep Disturbance T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -3.5 (-6.8, -0.3).|Each active JBT-101 cohort is compared to placebo.||4.91|-4.74|0.607
70978507|NCT03093402|141465079|SUPERIORITY||Mean Difference (Final Values)|2.93||||0.607|TWO_SIDED|95.0|-1.85|7.71||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Sleep Disturbance T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -3.5 (-6.8, -0.3).|Each active JBT-101 cohort is compared to placebo.||7.71|-1.85|0.607
70978508|NCT03093402|141465079|SUPERIORITY||Mean Difference (Final Values)|1.44||||0.607|TWO_SIDED|95.0|-3.22|6.09||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Sleep Disturbance T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -3.5 (-6.8, -0.3).|Each active JBT-101 cohort is compared to placebo.||6.09|-3.22|0.607
70978509|NCT03093402|141465080|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.981|TWO_SIDED|95.0|-4.66|4.3||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Social Role Satisfaction T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 4.2 (0.8, 7.6).|||4.30|-4.66|0.981
70978510|NCT03093402|141465080|SUPERIORITY||Mean Difference (Final Values)|0.51||||0.981|TWO_SIDED|95.0|-3.84|4.86||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Social Role Satisfaction T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 4.2 (0.8, 7.6).|||4.86|-3.84|0.981
70978511|NCT03093402|141465080|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.981|TWO_SIDED|95.0|-4.62|4.08||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Social Role Satisfaction T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 4.2 (0.8, 7.6).|||4.08|-4.62|0.981
70978512|NCT03093402|141465081|SUPERIORITY||Mean Difference (Final Values)|-1.85||||0.653|TWO_SIDED|95.0|-6.0|2.29||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Pain Interference T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -4.9 (-7.6, -2.1).|Each active JBT-101 cohort is compared to placebo.||2.29|-6.00|0.653
70978513|NCT03093402|141465081|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.653|TWO_SIDED|95.0|-3.1|4.88||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Pain Interference T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -4.9 (-7.6, -2.1).|Each active JBT-101 cohort is compared to placebo.||4.88|-3.10|0.653
71034665|NCT03086460|141578862|SUPERIORITY||Mean Difference (Final Values)|0.078||||0.005|TWO_SIDED|95.0|0.024|0.132|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.132|0.024|0.005
71034666|NCT03086460|141578862|SUPERIORITY||Mean Difference (Final Values)|0.101|||<|0.001|TWO_SIDED|95.0|0.049|0.153|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.153|0.049|<0.001
71034667|NCT03086460|141578862|SUPERIORITY||Mean Difference (Final Values)|0.039||||0.187|TWO_SIDED|95.0|-0.019|0.097|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.097|-0.019|0.187
70978514|NCT03093402|141465081|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.653|TWO_SIDED|95.0|-4.31|3.67||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Pain Interference T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -4.9 (-7.6, -2.1).|Each active JBT-101 cohort is compared to placebo.||3.67|-4.31|0.653
70978515|NCT03093402|141465082|SUPERIORITY||Mean Difference (Final Values)|-1.13||||0.245|TWO_SIDED|95.0|-2.56|0.29||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Pain Intensity at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -1.1 (-2.1, -0.1).|||0.29|-2.56|0.245
70978516|NCT03093402|141465082|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.245|TWO_SIDED|95.0|-1.93|0.8||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Pain Intensity at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -1.1 (-2.1, -0.1).|||0.80|-1.93|0.245
70978517|NCT03093402|141465082|SUPERIORITY||Mean Difference (Final Values)|-1.28||||0.245|TWO_SIDED|95.0|-2.64|0.09||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Pain Intensity at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -1.1 (-2.1, -0.1).|||0.09|-2.64|0.245
71034668|NCT03086460|141578862|SUPERIORITY||Mean Difference (Final Values)|0.062||||0.028|TWO_SIDED|95.0|0.007|0.116|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.116|0.007|0.028
71096254|NCT04270760|141701418|SUPERIORITY||Treatment difference|-70.51|STANDARD_ERROR_OF_MEAN|2.35|<|0.001|TWO_SIDED|95.0|-75.12|-65.9||Adjusted p-value is reported based on the Hochberg procedure to control the type I error for multiple comparisons. Each individual adjusted p-value is compared to 0.05 to determine statistical significance.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 36.|Group 1 versus (vs) Group 5||-65.90|-75.12|<0.001
70978518|NCT03093402|141465083|SUPERIORITY||Mean Difference (Final Values)|-0.45||||0.608|TWO_SIDED|95.0|-4.45|3.54||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Cognitive Function T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 1.4 (-1.5, 4.4).|Each active JBT-101 cohort is compared to placebo.||3.54|-4.45|0.608
70978519|NCT03093402|141465083|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.608|TWO_SIDED|95.0|-2.27|5.47||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Cognitive Function T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 1.4 (-1.5, 4.4).|Each active JBT-101 cohort is compared to placebo.||5.47|-2.27|0.608
71034669|NCT03086460|141578862|SUPERIORITY||Mean Difference (Final Values)|0.023||||0.406|TWO_SIDED|95.0|-0.031|0.076|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.076|-0.031|0.406
71034670|NCT03086460|141578863|SUPERIORITY||Mean Difference (Final Values)|0.173|||<|0.001|TWO_SIDED|95.0|0.116|0.23|||ANCOVA|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.230|0.116|<0.001
71034671|NCT03086460|141578863|SUPERIORITY||Mean Difference (Final Values)|0.203|||<|0.001|TWO_SIDED|95.0|0.146|0.26|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.260|0.146|<0.001
71034672|NCT03086460|141578863|SUPERIORITY||Mean Difference (Final Values)|0.223|||<|0.001|TWO_SIDED|95.0|0.166|0.28|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.280|0.166|<0.001
70978520|NCT03093402|141465083|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.608|TWO_SIDED|95.0|-2.25|5.45||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Cognitive Function T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 1.4 (-1.5, 4.4).|Each active JBT-101 cohort is compared to placebo.||5.45|-2.25|0.608
70978521|NCT00004054|141465112|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04||||0.81|TWO_SIDED|95.0|0.76|1.43|||Log Rank|||The original target sample size was 1440 patients with a requirement of 340 deaths to test the hypothesis of overall survival (OS) efficacy of the hormones and RT plus chemotherapy arm; the design is based on detecting a 6% absolute improvement in 5-year OS from 79% to 85%, or a 33% relative reduction in the yearly hazard rate, with 90% power and a 2-sided significance level of 0.05.||1.43|0.76|0.81
70978522|NCT00004054|141465113|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.82|TWO_SIDED|95.0|0.74|1.27|||Gray's test|2-sided significance level of 0.05|Fine-Gray regression model was used to obtain the hazard ratio. Reference level = Hormones and RT.|||1.27|0.74|0.82
70978523|NCT00004054|141465114|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.09|TWO_SIDED|95.0|0.28|1.1|||Gray's test|2-sided significance level = 0.05|Fine-Gray regression model was used to obtain the hazard ratio. Reference level = Hormones and RT.|||1.10|0.28|0.09
70978524|NCT00004054|141465115|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.42|TWO_SIDED|95.0|0.48|1.36|||Gray's test|2-sided significance level = 0.05|Fine-Gray regression model was used to obtain the hazard ratio. Reference level = Hormones and RT.|||1.36|0.48|0.42
71034673|NCT03086460|141578863|SUPERIORITY||Mean Difference (Final Values)|0.27|||<|0.001|TWO_SIDED|95.0|0.216|0.325|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.325|0.216|<0.001
71034674|NCT03086460|141578863|SUPERIORITY||Mean Difference (Final Values)|0.241|||<|0.001|TWO_SIDED|95.0|0.187|0.295|||ANCOVA|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.295|0.187|<0.001
71034675|NCT03086460|141578863|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.308|TWO_SIDED|95.0|-0.028|0.089|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.089|-0.028|0.308
70978525|NCT00004054|141465116|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.61|TWO_SIDED|95.0|0.75|1.19|||Log Rank|2-sided significance level = 0.05|Cox proportional hazards model was used to obtain the hazard ratio. Reference level = Hormones and RT.|||1.19|0.75|0.61
70978526|NCT00619957|141465186|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|4.53|||<|0.0001|TWO_SIDED|95.0|3.46|5.6|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||5.60|3.46|<0.0001
70978527|NCT00619957|141465187|SUPERIORITY_OR_OTHER||LS Mean Difference|2.56|||<|0.0001|TWO_SIDED|95.0|1.66|3.47|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||3.47|1.66|<0.0001
70978528|NCT00619957|141465188|SUPERIORITY_OR_OTHER||LS Mean Difference|3.18|||<|0.0001|TWO_SIDED|95.0|2.19|4.16|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||4.16|2.19|<0.0001
70978529|NCT00619957|141465189|SUPERIORITY_OR_OTHER||LS Mean Difference|4.57|||<|0.0001|TWO_SIDED|95.0|3.49|5.66|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||5.66|3.49|<0.0001
71034676|NCT03086460|141578863|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.082|TWO_SIDED|95.0|-0.006|0.107|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.107|-0.006|0.082
71034677|NCT03086460|141578863|SUPERIORITY||Mean Difference (Final Values)|0.097|||<|0.001|TWO_SIDED|95.0|0.043|0.152|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.152|0.043|<0.001
71034678|NCT03086460|141578863|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.52|TWO_SIDED|95.0|-0.041|0.08|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.080|-0.041|0.520
71034679|NCT03086460|141578863|SUPERIORITY||Mean Difference (Final Values)|0.067||||0.022|TWO_SIDED|95.0|0.01|0.124|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.124|0.010|0.022
70978530|NCT00619957|141465190|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.1856|TWO_SIDED|95.0|-0.19|0.99|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||0.99|-0.19|0.1856
70978531|NCT00619957|141465191|SUPERIORITY_OR_OTHER||LS Mean Difference|0.65||||0.0346|TWO_SIDED|95.0|0.05|1.25|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.25|0.05|0.0346
70978532|NCT00619957|141465192|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7|||<|0.0001|TWO_SIDED|95.0|0.98|2.41|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||2.41|0.98|<0.0001
70978533|NCT00619957|141465193|SUPERIORITY_OR_OTHER||LS Mean Difference|1.46|||<|0.0001|TWO_SIDED|95.0|0.76|2.17|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||2.17|0.76|<0.0001
70978534|NCT00619957|141465194|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.2538|TWO_SIDED|95.0|-0.36|1.36|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.36|-0.36|0.2538
70978535|NCT00619957|141465195|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86||||0.0537|TWO_SIDED|95.0|-0.01|1.74|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.74|-0.01|0.0537
71034680|NCT03086460|141578863|SUPERIORITY||Mean Difference (Final Values)|0.047||||0.098|TWO_SIDED|95.0|-0.009|0.103|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.103|-0.009|0.098
71034681|NCT03086460|141578863|SUPERIORITY||Mean Difference (Final Values)|0.153|||<|0.001|TWO_SIDED|95.0|0.095|0.21|||ANCOVA|||"Day 14~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.210|0.095|<0.001
71096255|NCT04270760|141701418|SUPERIORITY||Treatment difference|-97.38|STANDARD_ERROR_OF_MEAN|2.35|<|0.001|TWO_SIDED|95.0|-101.98|-92.77||Adjusted p-value is reported based on the Hochberg procedure to control the type I error for multiple comparisons. Each individual adjusted p-value is compared to 0.05 to determine statistical significance.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 36.|Group 2 vs Group 5||-92.77|-101.98|<0.001
70978536|NCT00619957|141465196|SUPERIORITY_OR_OTHER||LS Mean Difference|1.24||||0.0081|TWO_SIDED|95.0|0.32|2.15|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||2.15|0.32|0.0081
70978537|NCT00619957|141465197|SUPERIORITY_OR_OTHER||LS Mean Difference|1.06||||0.0187|TWO_SIDED|95.0|0.18|1.94|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.94|0.18|0.0187
70978538|NCT00619957|141465198|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.1408|TWO_SIDED|95.0|-0.19|1.34|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.34|-0.19|0.1408
71034682|NCT03086460|141578863|SUPERIORITY||Mean Difference (Final Values)|0.19|||<|0.001|TWO_SIDED|95.0|0.131|0.249|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.249|0.131|<0.001
70978539|NCT00619957|141465199|SUPERIORITY_OR_OTHER||LS Mean Difference|1.07||||0.0129|TWO_SIDED|95.0|0.23|1.92|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.92|0.23|0.0129
70978540|NCT00619957|141465200|SUPERIORITY_OR_OTHER||LS Mean Difference|2.31|||<|0.0001|TWO_SIDED|95.0|1.35|3.26|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||3.26|1.35|<0.0001
70978541|NCT00619957|141465201|SUPERIORITY_OR_OTHER||LS Mean Difference|2.15|||<|0.0001|TWO_SIDED|95.0|1.22|3.08|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||3.08|1.22|<0.0001
70978542|NCT00619957|141465202|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.6|||<|0.0001|TWO_SIDED|95.0|-51.52|-35.67|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-35.67|-51.52|<0.0001
70978543|NCT00619957|141465203|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.72|||<|0.0001|TWO_SIDED|95.0|-58.01|-31.43|||ANOVA|Fixed effects for treatment and pooled center||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-31.43|-58.01|<0.0001
70978544|NCT00619957|141465204|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.33|||<|0.0001|TWO_SIDED|95.0|-55.99|-28.67|||ANOVA|Fixed effects for treatment and pooled centers.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-28.67|-55.99|<0.0001
70978545|NCT00619957|141465205|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.55|||<|0.0001|TWO_SIDED|95.0|-59.38|-33.72|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-33.72|-59.38|<0.0001
70978546|NCT00619957|141465206|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.15|||<|0.0001|TWO_SIDED|95.0|-57.01|-33.29|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-33.29|-57.01|<0.0001
71034683|NCT03086460|141578863|SUPERIORITY||Mean Difference (Final Values)|0.17|||<|0.001|TWO_SIDED|95.0|0.113|0.228|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.228|0.113|<0.001
71034684|NCT03086460|141578863|SUPERIORITY||Mean Difference (Final Values)|0.217|||<|0.001|TWO_SIDED|95.0|0.162|0.272|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.272|0.162|<0.001
71034685|NCT03086460|141578863|SUPERIORITY||Mean Difference (Final Values)|0.198|||<|0.001|TWO_SIDED|95.0|0.144|0.252|||ANCOVA|||"Day 14~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.252|0.144|<0.001
71034686|NCT03086460|141578863|SUPERIORITY||Mean Difference (Final Values)|0.037||||0.203|TWO_SIDED|95.0|-0.02|0.095|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.095|-0.020|0.203
71034687|NCT03086460|141578863|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.542|TWO_SIDED|95.0|-0.039|0.074|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.074|-0.039|0.542
71034688|NCT03086460|141578863|SUPERIORITY||Mean Difference (Final Values)|0.064||||0.021|TWO_SIDED|95.0|0.01|0.119|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.119|0.010|0.021
70978547|NCT00619957|141465207|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.88|||<|0.0001|TWO_SIDED|95.0|-23.43|-8.32|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-8.32|-23.43|<0.0001
70978548|NCT00619957|141465208|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.0|||<|0.0001|TWO_SIDED|95.0|-31.08|-12.91|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-12.91|-31.08|<0.0001
70978549|NCT00619957|141465209|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.96|||<|0.0001|TWO_SIDED|95.0|-30.75|-13.17|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-13.17|-30.75|<0.0001
70978550|NCT00619957|141465210|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.11||||0.0012|TWO_SIDED|95.0|-24.2|-6.02|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-6.02|-24.20|0.0012
70978551|NCT00619957|141465211|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.37||||0.0003|TWO_SIDED|95.0|-25.24|-7.49|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-7.49|-25.24|0.0003
70978552|NCT00619957|141465212|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.64|||<|0.0001|TWO_SIDED|95.0|-19.29|-11.99|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-11.99|-19.29|<0.0001
70978553|NCT00619957|141465213|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.1|||<|0.0001|TWO_SIDED|95.0|-25.61|-16.59|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-16.59|-25.61|<0.0001
71034689|NCT03086460|141578863|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.51|TWO_SIDED|95.0|-0.08|0.04|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.040|-0.080|0.510
70978554|NCT00619957|141465214|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.39|||<|0.0001|TWO_SIDED|95.0|-27.8|-16.98|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-16.98|-27.80|<0.0001
70978555|NCT00619957|141465215|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.15|||<|0.0001|TWO_SIDED|95.0|-39.84|-16.47|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-16.47|-39.84|<0.0001
71034690|NCT03086460|141578863|SUPERIORITY||Mean Difference (Final Values)|0.027||||0.352|TWO_SIDED|95.0|-0.03|0.084|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.084|-0.030|0.352
71034691|NCT03086460|141578863|SUPERIORITY||Mean Difference (Final Values)|0.047||||0.098|TWO_SIDED|95.0|-0.009|0.103|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.103|-0.009|0.098
71034692|NCT03086460|141578864|SUPERIORITY||Mean Difference (Final Values)|0.181|||<|0.001|TWO_SIDED|95.0|0.122|0.241|||ANCOVA|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.241|0.122|<0.001
71034693|NCT03086460|141578864|SUPERIORITY||Mean Difference (Final Values)|0.192|||<|0.001|TWO_SIDED|95.0|0.133|0.251|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.251|0.133|<0.001
71096256|NCT04270760|141701418|SUPERIORITY||Treatment difference|-101.13|STANDARD_ERROR_OF_MEAN|2.38|<|0.001|TWO_SIDED|95.0|-105.79|-96.47||Adjusted p-value is reported based on the Hochberg procedure to control the type I error for multiple comparisons. Each individual adjusted p-value is compared to 0.05 to determine statistical significance.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 36.|Group 3 vs Group 5||-96.47|-105.79|<0.001
70978556|NCT00619957|141465216|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.25|||<|0.0001|TWO_SIDED|95.0|-37.63|-16.87|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-16.87|-37.63|<0.0001
70978557|NCT00619957|141465217|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14||||0.8794|TWO_SIDED|95.0|-1.99|1.71|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.71|-1.99|0.8794
70978558|NCT00619957|141465218|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47||||0.6658|TWO_SIDED|95.0|-2.62|1.67|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.67|-2.62|0.6658
70978559|NCT00619957|141465219|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29||||0.784|TWO_SIDED|95.0|-2.39|1.81|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.81|-2.39|0.7840
70978560|NCT00619957|141465220|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Controlled for pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||||<0.0001
70978561|NCT00619957|141465221|SUPERIORITY_OR_OTHER||Relative Risk|0.771||||0.7284||95.0|0.184|3.226|||Log Rank|||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||3.226|0.184|0.7284
70978562|NCT00619957|141465222|SUPERIORITY_OR_OTHER||Relative Risk|0.688||||0.5293|TWO_SIDED|95.0|0.245|1.932|||Log Rank|||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.932|0.245|0.5293
70978563|NCT00190775|141465223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.78|STANDARD_ERROR_OF_MEAN|1.11|<|0.001||95.0|||||Mixed Models Analysis|Model included visit, baseline, treatment, pooled investigator, child with ADHD, and treatment by visit.|Least Squares Mean Difference = Atomoxetine - Placebo.|Approximately 500 participants were randomized to atomoxetine or placebo (1:1) which provided at least 90% power to detect a treatment difference of 3.64 points on the CAARS-Inv:SV Total ADHD Symptoms Score assuming a SD of 9.85 based on 2-sided significance level of 0.05 using a 2-sample t-test. Mean and SD assumptions were associated with effect size of 0.37 and 30% missing data rate. These assumptions applied to Weeks 12 and 24 treatment effects. Marginal power at Weeks 12 and 24 was 86%.||||<0.001
70978564|NCT00190775|141465224|SUPERIORITY_OR_OTHER|||||||0.905||95.0||||P-Value for Task Accomplishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.905
70978565|NCT00190775|141465224|SUPERIORITY_OR_OTHER|||||||0.491||95.0||||P-Value for Role Performance.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.491
70978566|NCT00190775|141465224|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||P-Value for Communication.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.600
70978567|NCT00190775|141465224|SUPERIORITY_OR_OTHER|||||||0.052||95.0||||P-Value for Affective Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.052
70978568|NCT00190775|141465224|SUPERIORITY_OR_OTHER|||||||0.514||95.0||||P-Value for Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.514
70978569|NCT00190775|141465224|SUPERIORITY_OR_OTHER|||||||0.515||95.0||||P-Value for Control.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.515
70978570|NCT00190775|141465224|SUPERIORITY_OR_OTHER|||||||0.315||95.0||||P-Value for Values and Norms.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.315
71096257|NCT04270760|141701418|SUPERIORITY||Treatment difference|-100.49|STANDARD_ERROR_OF_MEAN|2.38|<|0.001|TWO_SIDED|95.0|-105.16|-95.82|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 36.|Group 4 vs Group 5||-95.82|-105.16|< 0.001
70978571|NCT00190775|141465225|SUPERIORITY_OR_OTHER|||||||0.176||95.0||||P-Value for Task Accomplishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.176
70978572|NCT00190775|141465225|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||P-Value for Role Performance.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.122
70978573|NCT00190775|141465225|SUPERIORITY_OR_OTHER|||||||0.931||95.0||||P-Value for Communication.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.931
71096258|NCT04270760|141701419|SUPERIORITY||Treatment difference|-68.47|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|-74.27|-62.67|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 48.|Group 1 vs Group 5||-62.67|-74.27|<0.001
70978574|NCT00190775|141465225|SUPERIORITY_OR_OTHER|||||||0.788||95.0||||P-Value for Affective Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.788
70978575|NCT00190775|141465225|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||P-Value for Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.190
70978576|NCT00190775|141465225|SUPERIORITY_OR_OTHER|||||||0.36||95.0||||P-Value for Control.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.360
70978577|NCT00190775|141465225|SUPERIORITY_OR_OTHER|||||||0.446||95.0||||P-Value for Values and Norms.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.446
70978578|NCT00190775|141465226|SUPERIORITY_OR_OTHER|||||||0.575||95.0||||P-Value for Task Accomplishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.575
70978579|NCT00190775|141465226|SUPERIORITY_OR_OTHER|||||||0.705||95.0||||P-Value for Role Performance.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.705
70978580|NCT00190775|141465226|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||P-Value for Communication.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.686
70978581|NCT00190775|141465226|SUPERIORITY_OR_OTHER|||||||0.618||95.0||||P-Value for Affective Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.618
70978582|NCT00190775|141465226|SUPERIORITY_OR_OTHER|||||||0.903||95.0||||P-Value for Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.903
70978583|NCT00190775|141465226|SUPERIORITY_OR_OTHER|||||||0.807||95.0||||P-Value for Control.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.807
70978584|NCT00190775|141465226|SUPERIORITY_OR_OTHER|||||||0.403||95.0||||P-Value for Values and Norms.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.403
70978585|NCT00190775|141465227|SUPERIORITY_OR_OTHER|||||||0.941||95.0||||P-Value for Task Accomplishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.941
70978586|NCT00190775|141465227|SUPERIORITY_OR_OTHER|||||||0.788||95.0||||P-Value for Role Performance.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.788
70978587|NCT00190775|141465227|SUPERIORITY_OR_OTHER|||||||0.391||95.0||||P-Value for Communication.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.391
70978588|NCT00190775|141465227|SUPERIORITY_OR_OTHER|||||||0.685||95.0||||P-Value for Affective Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.685
70978589|NCT00190775|141465227|SUPERIORITY_OR_OTHER|||||||0.774||95.0||||P-Value for Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.774
70978590|NCT00190775|141465227|SUPERIORITY_OR_OTHER|||||||0.36||95.0||||P-Value for Control.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.360
70978591|NCT00190775|141465227|SUPERIORITY_OR_OTHER|||||||0.446||95.0||||P-Value for Values and Norms.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.446
70978592|NCT00190775|141465228|SUPERIORITY_OR_OTHER|||||||0.617||95.0||||P-Value for Total Dyadic Adjustment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.617
70978593|NCT00190775|141465228|SUPERIORITY_OR_OTHER|||||||0.789||95.0||||P-Value for Dyadic Consensus.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.789
70978594|NCT00190775|141465228|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||P-Value for Dyadic Satisfaction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.670
70978595|NCT00190775|141465228|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||P-Value for Affectional Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.018
70978596|NCT00190775|141465228|SUPERIORITY_OR_OTHER|||||||0.405||95.0||||P-Value for Dyadic Cohesion.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.405
70978597|NCT00190775|141465229|SUPERIORITY_OR_OTHER|||||||0.544||95.0||||P-Value for Total Dyadic Adjustment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.544
70978598|NCT00190775|141465229|SUPERIORITY_OR_OTHER|||||||0.494||95.0||||P-Value for Dyadic Consensus.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.494
70978599|NCT00190775|141465229|SUPERIORITY_OR_OTHER|||||||0.547||95.0||||P-Value for Dyadic Satisfaction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.547
71096259|NCT04270760|141701419|SUPERIORITY||Treatment difference|-96.12|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|-101.92|-90.33|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 48.|Group 2 vs Group 5||-90.33|-101.92|<0.001
71034694|NCT03086460|141578864|SUPERIORITY||Mean Difference (Final Values)|0.215|||<|0.001|TWO_SIDED|95.0|0.156|0.275|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.275|0.156|<0.001
71034695|NCT03086460|141578864|SUPERIORITY||Mean Difference (Final Values)|0.252|||<|0.001|TWO_SIDED|95.0|0.195|0.309|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.309|0.195|<0.001
71034696|NCT03086460|141578864|SUPERIORITY||Mean Difference (Final Values)|0.238|||<|0.001|TWO_SIDED|95.0|0.182|0.295|||ANCOVA|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.295|0.182|<0.001
71034697|NCT03086460|141578864|SUPERIORITY||Mean Difference (Final Values)|0.011||||0.723|TWO_SIDED|95.0|-0.049|0.071|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.071|-0.049|0.723
71034698|NCT03086460|141578864|SUPERIORITY||Mean Difference (Final Values)|0.034||||0.257|TWO_SIDED|95.0|-0.025|0.093|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.093|-0.025|0.257
71034699|NCT03086460|141578864|SUPERIORITY||Mean Difference (Final Values)|0.071||||0.016|TWO_SIDED|95.0|0.014|0.128|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.128|0.014|0.016
71034700|NCT03086460|141578864|SUPERIORITY||Mean Difference (Final Values)|0.023||||0.464|TWO_SIDED|95.0|-0.039|0.086|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.086|-0.039|0.464
71034701|NCT03086460|141578864|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.048|TWO_SIDED|95.0|0.0|0.12|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.120|0.000|0.048
71034702|NCT03086460|141578864|SUPERIORITY||Mean Difference (Final Values)|0.037||||0.219|TWO_SIDED|95.0|-0.022|0.095|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.095|-0.022|0.219
71034703|NCT03086460|141578864|SUPERIORITY||Mean Difference (Final Values)|0.163|||<|0.001|TWO_SIDED|95.0|0.1|0.226|||ANCOVA|||"Day 14~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.226|0.100|<0.001
71034704|NCT03086460|141578864|SUPERIORITY||Mean Difference (Final Values)|0.19|||<|0.001|TWO_SIDED|95.0|0.126|0.254|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.254|0.126|<0.001
71034705|NCT03086460|141578864|SUPERIORITY||Mean Difference (Final Values)|0.166|||<|0.001|TWO_SIDED|95.0|0.103|0.229|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.229|0.103|<0.001
71034706|NCT03086460|141578864|SUPERIORITY||Mean Difference (Final Values)|0.206|||<|0.001|TWO_SIDED|95.0|0.146|0.266|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.266|0.146|<0.001
71034707|NCT03086460|141578864|SUPERIORITY||Mean Difference (Final Values)|0.184|||<|0.001|TWO_SIDED|95.0|0.125|0.243|||ANCOVA|||"Day 14~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.243|0.125|<0.001
71034708|NCT03086460|141578864|SUPERIORITY||Mean Difference (Final Values)|0.027||||0.4|TWO_SIDED|95.0|-0.036|0.09|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.090|-0.036|0.400
71034709|NCT03086460|141578864|SUPERIORITY||Mean Difference (Final Values)|0.003||||0.931|TWO_SIDED|95.0|-0.059|0.064|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.064|-0.059|0.931
71034710|NCT03086460|141578864|SUPERIORITY||Mean Difference (Final Values)|0.043||||0.16|TWO_SIDED|95.0|-0.017|0.102|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.102|-0.017|0.160
71034711|NCT03086460|141578864|SUPERIORITY||Mean Difference (Final Values)|-0.024||||0.464|TWO_SIDED|95.0|-0.09|0.041|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.041|-0.090|0.464
71034712|NCT03086460|141578864|SUPERIORITY||Mean Difference (Final Values)|0.016||||0.623|TWO_SIDED|95.0|-0.047|0.078|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.078|-0.047|0.623
71034713|NCT03086460|141578864|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.197|TWO_SIDED|95.0|-0.021|0.101|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.101|-0.021|0.197
70978600|NCT00190775|141465229|SUPERIORITY_OR_OTHER|||||||0.059||95.0||||P-Value for Affectional Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.059
70978601|NCT00190775|141465229|SUPERIORITY_OR_OTHER|||||||0.918||95.0||||P-Value for Dyadic Cohesion.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.918
70978602|NCT00190775|141465230|SUPERIORITY_OR_OTHER|||||||0.334||95.0||||P-Value for Total Dyadic Adjustment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.334
70978603|NCT00190775|141465230|SUPERIORITY_OR_OTHER|||||||0.087||95.0||||P-Value for Dyadic Consensus.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.087
70978604|NCT00190775|141465230|SUPERIORITY_OR_OTHER|||||||0.795||95.0||||P-Value for Dyadic Satisfaction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.795
70978605|NCT00190775|141465230|SUPERIORITY_OR_OTHER|||||||0.955||95.0||||P-Value for Affectional Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.955
71034714|NCT03086460|141578865|SUPERIORITY||Mean Difference (Final Values)|0.052||||0.098|TWO_SIDED|95.0|-0.01|0.113|||ANCOVA|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.113|-0.010|0.098
71096260|NCT04270760|141701419|SUPERIORITY||Treatment difference|-100.88|STANDARD_ERROR_OF_MEAN|2.99|<|0.001|TWO_SIDED|95.0|-106.74|-95.02|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 48.|Group 3 vs Group 5||-95.02|-106.74|<0.001
70978606|NCT00190775|141465230|SUPERIORITY_OR_OTHER|||||||0.788||95.0||||P-Value for Dyadic Cohesion.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.788
70978607|NCT00190775|141465231|SUPERIORITY_OR_OTHER|||||||0.248||95.0||||P-Value for Total Dyadic Adjustment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.248
70978608|NCT00190775|141465231|SUPERIORITY_OR_OTHER|||||||0.163||95.0||||P-Value for Dyadic Consensus.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.163
70978609|NCT00190775|141465231|SUPERIORITY_OR_OTHER|||||||0.947||95.0||||P-Value for Dyadic Satisfaction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.947
70978610|NCT00190775|141465231|SUPERIORITY_OR_OTHER|||||||0.214||95.0||||P-Value for Affectional Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.214
70978611|NCT00190775|141465231|SUPERIORITY_OR_OTHER|||||||0.543||95.0||||P-Value for Dyadic Cohesion.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.543
70978612|NCT00190775|141465232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.28|STANDARD_ERROR_OF_MEAN|1.05||0.001||95.0|||||Mixed Models Analysis|Model included visit, baseline, treatment, pooled investigator, child with ADHD, and treatment by visit.|Least Squares Mean Difference = Atomoxetine - Placebo.|Approximately 500 participants were randomized to atomoxetine or placebo (1:1) which provided at least 90% power to detect a treatment difference of 3.64 points on the CAARS-Inv:SV Total ADHD Symptoms Score assuming a SD of 9.85 based on 2-sided significance level of 0.05 using a 2-sample t-test. Mean and SD assumptions were associated with effect size of 0.37 and 30% missing data rate. These assumptions applied to Weeks 12 and 24 treatment effects. Marginal power at Weeks 12 and 24 was 86%.||||0.001
70978613|NCT00190775|141465233|SUPERIORITY_OR_OTHER|||||||0.446||95.0||||P-Value for Total Stress.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.446
70978614|NCT00190775|141465233|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||P-Value for Life Stress.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.134
70978615|NCT00190775|141465234|SUPERIORITY_OR_OTHER|||||||0.056||95.0||||P-Value for Parent Domain Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.056
70978616|NCT00190775|141465234|SUPERIORITY_OR_OTHER|||||||0.459||95.0||||P-Value for Parent Domain Competence.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.459
70978617|NCT00190775|141465234|SUPERIORITY_OR_OTHER|||||||0.435||95.0||||P-Value for Parent Domain Isolation.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.435
70978618|NCT00190775|141465234|SUPERIORITY_OR_OTHER|||||||0.677||95.0||||P-Value for Parent Domain Attachment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.677
70978619|NCT00190775|141465234|SUPERIORITY_OR_OTHER|||||||0.376||95.0||||P-Value for Parent Domain Health.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.376
70978620|NCT00190775|141465234|SUPERIORITY_OR_OTHER|||||||0.176||95.0||||P-Value for Parent Domain Role Restriction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.176
70978621|NCT00190775|141465234|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-Value for Parent Domain Depression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.030
70978622|NCT00190775|141465234|SUPERIORITY_OR_OTHER|||||||0.434||95.0||||P-Value for Parent Domain Spouse.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.434
70978623|NCT00190775|141465235|SUPERIORITY_OR_OTHER|||||||0.578||95.0||||P-Value for Child Domain Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.578
71034715|NCT03086460|141578865|SUPERIORITY||Mean Difference (Final Values)|0.097||||0.002|TWO_SIDED|95.0|0.035|0.159|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.159|0.035|0.002
71096261|NCT04270760|141701419|SUPERIORITY||Treatment difference|-85.94|STANDARD_ERROR_OF_MEAN|3.0|<|0.001|TWO_SIDED|95.0|-91.83|-80.06|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 48.|Group 4 vs Group 5||-80.06|-91.83|< 0.001
70978624|NCT00190775|141465235|SUPERIORITY_OR_OTHER|||||||0.062||95.0||||P-Value for Defensive Responding.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.062
70978625|NCT00190775|141465235|SUPERIORITY_OR_OTHER|||||||0.567||95.0||||P-Value for Child Domain Distractibility/Hyperactive.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.567
71034716|NCT03086460|141578865|SUPERIORITY||Mean Difference (Final Values)|0.101||||0.002|TWO_SIDED|95.0|0.039|0.163|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.163|0.039|0.002
70978626|NCT00190775|141465235|SUPERIORITY_OR_OTHER|||||||0.383||95.0||||P-Value for Child Domain Adaptability.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.383
70978627|NCT00190775|141465235|SUPERIORITY_OR_OTHER|||||||0.963||95.0||||P-Value for Child Domain Reinforces Parent.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.963
70978628|NCT00190775|141465235|SUPERIORITY_OR_OTHER|||||||0.075||95.0||||P-Value for Child Domain Demandingness.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.075
70978629|NCT00190775|141465235|SUPERIORITY_OR_OTHER|||||||0.854||95.0||||P-Value for Child Domain Mood.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.854
71034717|NCT03086460|141578865|SUPERIORITY||Mean Difference (Final Values)|0.122|||<|0.001|TWO_SIDED|95.0|0.063|0.182|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.182|0.063|<0.001
71096262|NCT04270760|141701420|SUPERIORITY||Treatment difference|-23.659|STANDARD_ERROR_OF_MEAN|5.874|<|0.001|TWO_SIDED|95.0|-35.176|-12.143|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 1 vs Group 5||-12.143|-35.176|<0.001
70978630|NCT00190775|141465235|SUPERIORITY_OR_OTHER|||||||0.671||95.0||||P-Value for Child Domain Acceptability.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.671
70978631|NCT00190775|141465236|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||P-Value for Total Stress.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.280
70978632|NCT00190775|141465236|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||P-Value for Life Stress.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.34
70978633|NCT00190775|141465237|SUPERIORITY_OR_OTHER|||||||0.103||95.0||||P-Value for Parent Domain Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.103
70978634|NCT00190775|141465237|SUPERIORITY_OR_OTHER|||||||0.182||95.0||||P-Value for Parent Domain Competence.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.182
70978635|NCT00190775|141465237|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-Value for Parent Domain Isolation.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.161
70978636|NCT00190775|141465237|SUPERIORITY_OR_OTHER|||||||0.472||95.0||||P-Value for Parent Domain Attachment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.472
70978637|NCT00190775|141465237|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||P-Value for Parent Domain Health.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.949
70978638|NCT00190775|141465237|SUPERIORITY_OR_OTHER|||||||0.848||95.0||||P-Value for Parent Domain Role Restriction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.848
70978639|NCT00190775|141465237|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-Value for Parent Domain Depression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.050
70978640|NCT00190775|141465237|SUPERIORITY_OR_OTHER|||||||0.84||95.0||||P-Value for Parent Domain Spouse.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.840
70978641|NCT00190775|141465238|SUPERIORITY_OR_OTHER|||||||0.785||95.0||||P-Value for Child Domain Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.785
70978642|NCT00190775|141465238|SUPERIORITY_OR_OTHER|||||||0.081||95.0||||P-Value for Defensive Responding.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.081
70978643|NCT00190775|141465238|SUPERIORITY_OR_OTHER|||||||0.518||95.0||||P-Value for Child Domain Distractibility/Hyperactive.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.518
70978644|NCT00190775|141465238|SUPERIORITY_OR_OTHER|||||||0.883||95.0||||P-Value for Child Domain Adaptability.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.883
70978645|NCT00190775|141465238|SUPERIORITY_OR_OTHER|||||||0.439||95.0||||P-Value for Child Domain Reinforces Parent.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.439
70978646|NCT00190775|141465238|SUPERIORITY_OR_OTHER|||||||0.167||95.0||||P-Value for Child Domain Demandingness.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.167
70978647|NCT00190775|141465238|SUPERIORITY_OR_OTHER|||||||0.381||95.0||||P-Value for Child Domain Mood.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.381
70978648|NCT00190775|141465238|SUPERIORITY_OR_OTHER|||||||0.906||95.0||||P-Value for Child Domain Acceptability.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.906
71034718|NCT03086460|141578865|SUPERIORITY||Mean Difference (Final Values)|0.112|||<|0.001|TWO_SIDED|95.0|0.054|0.171|||ANCOVA|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.171|0.054|<0.001
71034719|NCT03086460|141578865|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.162|TWO_SIDED|95.0|-0.018|0.108|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.108|-0.018|0.162
70978649|NCT00190775|141465239|SUPERIORITY_OR_OTHER|||||||0.42||95.0||||P-Value for Parent Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.420
70978650|NCT00190775|141465239|SUPERIORITY_OR_OTHER|||||||0.249||95.0||||P-Value for Parent Positive Parenting.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.249
70978651|NCT00190775|141465239|SUPERIORITY_OR_OTHER|||||||0.927||95.0||||P-Value for Parent Poor Supervision.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.927
70978652|NCT00190775|141465239|SUPERIORITY_OR_OTHER|||||||0.205||95.0||||P-Value for Parent Inconsistent Discipline.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.205
70978653|NCT00190775|141465239|SUPERIORITY_OR_OTHER|||||||0.673||95.0||||P-Value for Parent Corporal Punishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.673
70978654|NCT00190775|141465239|SUPERIORITY_OR_OTHER|||||||0.881||95.0||||P-Value for Parent Other Discipline Practice.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.881
70978655|NCT00190775|141465239|SUPERIORITY_OR_OTHER|||||||0.808||95.0||||P-Value for Dysfunctional Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.808
71096263|NCT04270760|141701420|SUPERIORITY||Treatment difference|-22.518|STANDARD_ERROR_OF_MEAN|5.875|<|0.001|TWO_SIDED|95.0|-34.036|-11.0|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 2 vs Group 5||-11.000|-34.036|<0.001
71096264|NCT04270760|141701420|SUPERIORITY||Treatment difference|-22.967|STANDARD_ERROR_OF_MEAN|5.962|<|0.001|TWO_SIDED|95.0|-34.656|-11.278|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 3 vs Group 5||-11.278|-34.656|<0.001
70978656|NCT00190775|141465239|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||P-Value for Negative Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.498
70978657|NCT00190775|141465239|SUPERIORITY_OR_OTHER|||||||0.283||95.0||||P-Value for Positive Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.283
70978658|NCT00190775|141465240|SUPERIORITY_OR_OTHER|||||||0.784||95.0||||P-Value for Parent Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.784
70978659|NCT00190775|141465240|SUPERIORITY_OR_OTHER|||||||0.864||95.0||||P-Value for Parent Positive Parenting.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.864
70978660|NCT00190775|141465240|SUPERIORITY_OR_OTHER|||||||0.884||95.0||||P-Value for Parent Poor Supervision.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.884
70978661|NCT00190775|141465240|SUPERIORITY_OR_OTHER|||||||0.072||95.0||||P-Value for Parent Inconsistent Discipline.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.072
70978662|NCT00190775|141465240|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||P-Value for Parent Corporal Punishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.120
70978663|NCT00190775|141465240|SUPERIORITY_OR_OTHER|||||||0.925||95.0||||P-Value Other Discipline Practice.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.925
70978664|NCT00190775|141465240|SUPERIORITY_OR_OTHER|||||||0.444||95.0||||P-Value for Dysfunctional Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.444
70978665|NCT00190775|141465240|SUPERIORITY_OR_OTHER|||||||0.166||95.0||||P-Value for Negative Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.166
70978666|NCT00190775|141465240|SUPERIORITY_OR_OTHER|||||||0.875||95.0||||P-Value for Positive Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.875
70978667|NCT00190775|141465241|SUPERIORITY_OR_OTHER|||||||0.895||95.0||||P-Value for Child Involvement Mother.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.895
70978668|NCT00190775|141465241|SUPERIORITY_OR_OTHER|||||||0.792||95.0||||P-Value for Child Involvement Father.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.792
70978669|NCT00190775|141465241|SUPERIORITY_OR_OTHER|||||||0.318||95.0||||P-Value for Child Positive Parenting.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.318
70978670|NCT00190775|141465241|SUPERIORITY_OR_OTHER|||||||0.914||95.0||||P-Value for Child Poor Supervision.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.914
70978671|NCT00190775|141465241|SUPERIORITY_OR_OTHER|||||||0.961||95.0||||P-Value for Child Inconsistent Discipline.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.961
70978672|NCT00190775|141465241|SUPERIORITY_OR_OTHER|||||||0.807||95.0||||P-Value for Child Corporal Punishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.807
70978673|NCT00190775|141465241|SUPERIORITY_OR_OTHER|||||||0.827||95.0||||P-Value for Child Other Discipline Practice.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.827
70978674|NCT00190775|141465242|SUPERIORITY_OR_OTHER|||||||0.828||95.0||||P-Value for Child Involvement Mother.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.828
70978675|NCT00190775|141465242|SUPERIORITY_OR_OTHER|||||||0.401||95.0||||P-Value for Child Involvement Father.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.401
70978676|NCT00190775|141465242|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||P-Value for Child Positive Parenting.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.300
71096265|NCT04270760|141701420|SUPERIORITY||Treatment difference|-24.696|STANDARD_ERROR_OF_MEAN|5.969|<|0.001|TWO_SIDED|95.0|-36.399|-12.993|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 4 vs Group 5||-12.993|-36.399|< 0.001
71034720|NCT03086460|141578865|SUPERIORITY||Mean Difference (Final Values)|0.049||||0.117|TWO_SIDED|95.0|-0.012|0.11|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.110|-0.012|0.117
71034721|NCT03086460|141578865|SUPERIORITY||Mean Difference (Final Values)|0.071||||0.02|TWO_SIDED|95.0|0.011|0.13|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.130|0.011|0.020
71034722|NCT03086460|141578865|SUPERIORITY||Mean Difference (Final Values)|0.004||||0.909|TWO_SIDED|95.0|-0.062|0.07|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.070|-0.062|0.909
71034723|NCT03086460|141578865|SUPERIORITY||Mean Difference (Final Values)|0.025||||0.419|TWO_SIDED|95.0|-0.037|0.088|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.088|-0.037|0.419
71034724|NCT03086460|141578865|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.483|TWO_SIDED|95.0|-0.039|0.083|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.083|-0.039|0.483
71034725|NCT03086460|141578865|SUPERIORITY||Mean Difference (Final Values)|0.043||||0.126|TWO_SIDED|95.0|-0.012|0.099|||ANCOVA|||"Day 14~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.099|-0.012|0.126
71034726|NCT03086460|141578865|SUPERIORITY||Mean Difference (Final Values)|0.074||||0.012|TWO_SIDED|95.0|0.017|0.131|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.131|0.017|0.012
71034727|NCT03086460|141578865|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.037|TWO_SIDED|95.0|0.004|0.116|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.116|0.004|0.037
71034728|NCT03086460|141578865|SUPERIORITY||Mean Difference (Final Values)|0.082||||0.003|TWO_SIDED|95.0|0.028|0.136|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.136|0.028|0.003
71034729|NCT03086460|141578865|SUPERIORITY||Mean Difference (Final Values)|0.074||||0.006|TWO_SIDED|95.0|0.021|0.127|||ANCOVA|||"Day 14~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.127|0.021|0.006
71034730|NCT03086460|141578865|SUPERIORITY||Mean Difference (Final Values)|0.031||||0.282|TWO_SIDED|95.0|-0.025|0.087|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.087|-0.025|0.282
71034731|NCT03086460|141578865|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.554|TWO_SIDED|95.0|-0.039|0.072|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.072|-0.039|0.554
71034732|NCT03086460|141578865|SUPERIORITY||Mean Difference (Final Values)|0.039||||0.149|TWO_SIDED|95.0|-0.014|0.091|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.091|-0.014|0.149
71034733|NCT03086460|141578865|SUPERIORITY||Mean Difference (Final Values)|-0.014||||0.636|TWO_SIDED|95.0|-0.072|0.044|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.044|-0.072|0.636
71034734|NCT03086460|141578865|SUPERIORITY||Mean Difference (Final Values)|0.008||||0.775|TWO_SIDED|95.0|-0.047|0.063|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.063|-0.047|0.775
71034735|NCT03086460|141578865|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.425|TWO_SIDED|95.0|-0.032|0.077|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.077|-0.032|0.425
71034736|NCT03086460|141578866|SUPERIORITY||Mean Difference (Final Values)|0.122|||<|0.001|TWO_SIDED|95.0|0.058|0.187|||ANCOVA|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.187|0.058|<0.001
71034737|NCT03086460|141578866|SUPERIORITY||Mean Difference (Final Values)|0.15|||<|0.001|TWO_SIDED|95.0|0.085|0.215|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.215|0.085|<0.001
71034738|NCT03086460|141578866|SUPERIORITY||Mean Difference (Final Values)|0.124|||<|0.001|TWO_SIDED|95.0|0.059|0.189|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.189|0.059|<0.001
71034739|NCT03086460|141578866|SUPERIORITY||Mean Difference (Final Values)|0.18|||<|0.001|TWO_SIDED|95.0|0.118|0.242|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.242|0.118|<0.001
71096266|NCT04270760|141701420|SUPERIORITY||Treatment difference|-24.856|STANDARD_ERROR_OF_MEAN|6.119|<|0.001|TWO_SIDED|95.0|-36.853|-12.859|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 1 vs Group 5||-12.859|-36.853|<0.001
71096267|NCT04270760|141701420|SUPERIORITY||Treatment difference|-21.594|STANDARD_ERROR_OF_MEAN|6.118|<|0.001|TWO_SIDED|95.0|-33.59|-9.598|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 2 vs Group 5||-9.598|-33.590|<0.001
71096268|NCT04270760|141701420|SUPERIORITY||Treatment difference|-27.421|STANDARD_ERROR_OF_MEAN|6.194|<|0.001|TWO_SIDED|95.0|-39.565|-15.277|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 3 vs Group 5||-15.277|-39.565|<0.001
71096269|NCT04270760|141701420|SUPERIORITY||Treatment difference|-27.021|STANDARD_ERROR_OF_MEAN|6.232|<|0.001|TWO_SIDED|95.0|-39.24|-14.801|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 4 vs Group 5||-14.801|-39.240|<0.001
71096270|NCT04270760|141701421|SUPERIORITY||Treatment difference|-18.89|STANDARD_ERROR_OF_MEAN|3.779|<|0.001|TWO_SIDED|95.0|-26.303|-11.477|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 1 vs Group 5||-11.477|-26.303|<0.001
71096271|NCT04270760|141701421|SUPERIORITY||Treatment difference|-16.696|STANDARD_ERROR_OF_MEAN|3.778|<|0.001|TWO_SIDED|95.0|-24.107|-9.284|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 2 vs Group 5||-9.284|-24.107|<0.001
71096272|NCT04270760|141701421|SUPERIORITY||Treatment difference|-17.635|STANDARD_ERROR_OF_MEAN|3.825|<|0.001|TWO_SIDED|95.0|-25.139|-10.131|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 3 vs Group 5||-10.131|-25.139|<0.001
70978677|NCT00190775|141465242|SUPERIORITY_OR_OTHER|||||||0.575||95.0||||P-Value for Child Poor Supervision.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.575
70978678|NCT00190775|141465242|SUPERIORITY_OR_OTHER|||||||0.772||95.0||||P-Value for Child Inconsistent Discipline.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.772
70978679|NCT00190775|141465242|SUPERIORITY_OR_OTHER|||||||0.918||95.0||||P-Value for Child Corporal Punishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.918
70978680|NCT00190775|141465242|SUPERIORITY_OR_OTHER|||||||0.636||95.0||||P-Value for Child Other Discipline Practice.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.636
70978681|NCT00190775|141465243|SUPERIORITY_OR_OTHER|||||||0.583||95.0||||P-Value for Total ADHD Score.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.583
70978682|NCT00190775|141465243|SUPERIORITY_OR_OTHER|||||||0.997||95.0||||P-Value for Hyperactive-Impulsive Symptom ADHD Score.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.997
70978683|NCT00190775|141465243|SUPERIORITY_OR_OTHER|||||||0.333||95.0||||P-Value for Inattention Symptom ADHD Score.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.333
71096273|NCT04270760|141701421|SUPERIORITY||Treatment difference|-18.772|STANDARD_ERROR_OF_MEAN|3.839|<|0.001|TWO_SIDED|95.0|-26.303|-11.241|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 4 vs Group 5||-11.241|-26.303|< 0.001
71096274|NCT04270760|141701421|SUPERIORITY||Treatment difference|-20.04|STANDARD_ERROR_OF_MEAN|4.443|<|0.001|TWO_SIDED|95.0|-28.757|-11.323|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 1 vs Group 5||-11.323|-28.757|<0.001
71096275|NCT04270760|141701421|SUPERIORITY||Treatment difference|-17.06|STANDARD_ERROR_OF_MEAN|4.442|<|0.001|TWO_SIDED|95.0|-25.774|-8.345|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 2 vs Group 5||-8.345|-25.774|<0.001
71096276|NCT04270760|141701421|SUPERIORITY||Treatment difference|-19.509|STANDARD_ERROR_OF_MEAN|4.5|<|0.001|TWO_SIDED|95.0|-28.336|-10.682|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 3 vs Group 5||-10.682|-28.336|<0.001
71096277|NCT04270760|141701421|SUPERIORITY||Treatment difference|-21.839|STANDARD_ERROR_OF_MEAN|4.517|<|0.001|TWO_SIDED|95.0|-30.7|-12.979|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 4 vs Group 5||-12.979|-30.700|<0.001
70978684|NCT00190775|141465244|SUPERIORITY_OR_OTHER|||||||0.792||95.0||||P-Value for Oppositional Defiant Disorder Flag|Fisher Exact|||||||.792
70978685|NCT00190775|141465244|SUPERIORITY_OR_OTHER|||||||0.675||95.0||||P-Value for Conduct Disorder Flag.|Fisher Exact|||||||0.675
70978686|NCT00190775|141465245|SUPERIORITY_OR_OTHER|||||||0.875||95.0||||P-Value for PSOC Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.875
70978687|NCT00190775|141465245|SUPERIORITY_OR_OTHER|||||||0.569||95.0||||P-Value for Satisfaction Scale.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.569
70978688|NCT00190775|141465245|SUPERIORITY_OR_OTHER|||||||0.399||95.0||||P-Value for Efficacy Scale.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.399
70978689|NCT00190775|141465246|SUPERIORITY_OR_OTHER|||||||0.365||95.0||||P-Value for PSOC Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.365
70978690|NCT00190775|141465246|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||P-Value for Satisfaction Scale.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.620
70978691|NCT00190775|141465246|SUPERIORITY_OR_OTHER|||||||0.462||95.0||||P-Value for Efficacy Scale.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.462
70978692|NCT00190775|141465247|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-Value for Total Score at 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.001
70978693|NCT00190775|141465247|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-Value for Hyperactivity Score at 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.004
70978694|NCT00190775|141465247|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Inattention Score at 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||<0.001
70978695|NCT00190775|141465247|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Total Score at 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||<0.001
70978696|NCT00190775|141465247|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Hyperactivity Score at 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||<0.001
70978697|NCT00190775|141465247|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Inattention Score at 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||<0.001
71034740|NCT03086460|141578866|SUPERIORITY||Mean Difference (Final Values)|0.177|||<|0.001|TWO_SIDED|95.0|0.115|0.238|||ANCOVA|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.238|0.115|<0.001
70978698|NCT00190775|141465248|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 8 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||<0.001
70978699|NCT00190775|141465248|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||<0.001
70978700|NCT00190775|141465249|SUPERIORITY_OR_OTHER|||||||0.553||95.0||||P-Value for 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.553
70978701|NCT00190775|141465249|SUPERIORITY_OR_OTHER|||||||0.797||95.0||||P-Value for 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.797
70978702|NCT00190775|141465250|SUPERIORITY_OR_OTHER|||||||0.108||95.0||||P-Value for State Anxiety Score at 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.108
70978703|NCT00190775|141465250|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||P-Value for Trait Anxiety Score at 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.026
71034741|NCT03086460|141578866|SUPERIORITY||Mean Difference (Final Values)|0.028||||0.41|TWO_SIDED|95.0|-0.039|0.094|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.094|-0.039|0.410
71034742|NCT03086460|141578866|SUPERIORITY||Mean Difference (Final Values)|0.002||||0.961|TWO_SIDED|95.0|-0.063|0.066|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.066|-0.063|0.961
71034743|NCT03086460|141578866|SUPERIORITY||Mean Difference (Final Values)|0.057||||0.07|TWO_SIDED|95.0|-0.005|0.119|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.119|-0.005|0.070
71034744|NCT03086460|141578866|SUPERIORITY||Mean Difference (Final Values)|-0.026||||0.454|TWO_SIDED|95.0|-0.095|0.043|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.043|-0.095|0.454
71034745|NCT03086460|141578866|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.37|TWO_SIDED|95.0|-0.035|0.095|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.095|-0.035|0.370
71034746|NCT03086460|141578866|SUPERIORITY||Mean Difference (Final Values)|0.056||||0.086|TWO_SIDED|95.0|-0.008|0.12|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.120|-0.008|0.086
71034747|NCT03086460|141578866|SUPERIORITY||Mean Difference (Final Values)|0.086||||0.011|TWO_SIDED|95.0|0.02|0.151|||ANCOVA|||"Day 14~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.151|0.020|0.011
71034748|NCT03086460|141578866|SUPERIORITY||Mean Difference (Final Values)|0.097||||0.005|TWO_SIDED|95.0|0.029|0.164|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.164|0.029|0.005
70978704|NCT00190775|141465250|SUPERIORITY_OR_OTHER|||||||0.897||95.0||||P-Value is for State Anxiety Score at 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.897
71034749|NCT03086460|141578866|SUPERIORITY||Mean Difference (Final Values)|0.087||||0.01|TWO_SIDED|95.0|0.021|0.153|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.153|0.021|0.010
71034750|NCT03086460|141578866|SUPERIORITY||Mean Difference (Final Values)|0.145|||<|0.001|TWO_SIDED|95.0|0.081|0.208|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.208|0.081|<0.001
71034751|NCT03086460|141578866|SUPERIORITY||Mean Difference (Final Values)|0.127|||<|0.001|TWO_SIDED|95.0|0.065|0.189|||ANCOVA|||"Day 14~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.189|0.065|<0.001
70978705|NCT00190775|141465250|SUPERIORITY_OR_OTHER|||||||0.171||95.0||||P-Value is for Trait Anxiety Score at 24 weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.171
70978706|NCT00190775|141465251|SUPERIORITY_OR_OTHER|||||||0.892||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.892
70978707|NCT00190775|141465251|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.003
70978708|NCT00190775|141465251|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.007
70978709|NCT00190775|141465251|SUPERIORITY_OR_OTHER|||||||0.533||95.0||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.533
70978710|NCT00190775|141465251|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.054
71034752|NCT03086460|141578866|SUPERIORITY||Mean Difference (Final Values)|0.011||||0.74|TWO_SIDED|95.0|-0.055|0.078|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.078|-0.055|0.740
70978711|NCT00190775|141465251|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.012
70978712|NCT00190775|141465251|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.457
70978713|NCT00190775|141465251|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.001
70978714|NCT00190775|141465251|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.021
70978715|NCT00190775|141465251|SUPERIORITY_OR_OTHER|||||||0.71||95.0||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.710
70978716|NCT00190775|141465251|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||<0.001
70978717|NCT00190775|141465251|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.005
70978718|NCT00190775|141465252|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.722
70978719|NCT00190775|141465252|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.011
71034753|NCT03086460|141578866|SUPERIORITY||Mean Difference (Final Values)|0.001||||0.973|TWO_SIDED|95.0|-0.064|0.066|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.066|-0.064|0.973
71034754|NCT03086460|141578866|SUPERIORITY||Mean Difference (Final Values)|0.059||||0.064|TWO_SIDED|95.0|-0.003|0.122|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.122|-0.003|0.064
71034755|NCT03086460|141578866|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.774|TWO_SIDED|95.0|-0.079|0.059|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.059|-0.079|0.774
71034756|NCT03086460|141578866|SUPERIORITY||Mean Difference (Final Values)|0.048||||0.151|TWO_SIDED|95.0|-0.018|0.113|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.113|-0.018|0.151
71034757|NCT03086460|141578866|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.076|TWO_SIDED|95.0|-0.006|0.122|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.122|-0.006|0.076
71034758|NCT03086460|141578867|SUPERIORITY||Mean Difference (Final Values)|0.114||||0.003|TWO_SIDED|95.0|0.039|0.19|||ANCOVA|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.190|0.039|0.003
71034759|NCT03086460|141578867|SUPERIORITY||Mean Difference (Final Values)|0.13|||<|0.001|TWO_SIDED|95.0|0.055|0.206|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.206|0.055|<0.001
70922481|NCT02376790|141336017|SUPERIORITY||LS Mean Treatment Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.34|TWO_SIDED|95.0|-0.15|0.05||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||0.05|-0.15|0.34
70922482|NCT02376790|141336017|SUPERIORITY||LS Mean Treatment Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.67|TWO_SIDED|95.0|-0.12|0.08||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||0.08|-0.12|0.67
70922483|NCT02376790|141336018|SUPERIORITY||LS Mean Treatment Difference|1.94|STANDARD_ERROR_OF_MEAN|0.8||0.015|TWO_SIDED|95.0|0.37|3.51||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in Physical Component Summary at week 24||3.51|0.37|0.015
70978720|NCT00190775|141465252|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.005
70978721|NCT00190775|141465252|SUPERIORITY_OR_OTHER|||||||0.779||95.0||||P-Value for Hyper/Impulsive Scale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.779
70978722|NCT00190775|141465252|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.004
70978723|NCT00190775|141465252|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.002
70978724|NCT00190775|141465252|SUPERIORITY_OR_OTHER|||||||0.716||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.716
70978725|NCT00190775|141465252|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.071
70922484|NCT02376790|141336018|SUPERIORITY||LS Mean Treatment Difference|1.71|STANDARD_ERROR_OF_MEAN|0.8||0.033|TWO_SIDED|95.0|0.13|3.28||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in Physical Component Summary at week 24||3.28|0.13|0.033
70978726|NCT00190775|141465252|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.034
70922485|NCT02376790|141336018|SUPERIORITY||LS Mean Treatment Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.84||0.97|TWO_SIDED|95.0|-1.69|1.63||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in Mental Component Summary at week 24||1.63|-1.69|0.97
70978727|NCT00190775|141465252|SUPERIORITY_OR_OTHER|||||||0.938||95.0||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.938
70978728|NCT00190775|141465252|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.004
70978729|NCT00190775|141465252|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.005
70978730|NCT00190775|141465253|SUPERIORITY_OR_OTHER|||||||0.546||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.546
70978731|NCT00190775|141465253|SUPERIORITY_OR_OTHER|||||||0.53||95.0||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.530
70978732|NCT00190775|141465253|SUPERIORITY_OR_OTHER|||||||0.569||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.569
70978733|NCT00190775|141465253|SUPERIORITY_OR_OTHER|||||||0.986||95.0||||P-Vaue for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.986
70978734|NCT01173653|141465256|SUPERIORITY_OR_OTHER||Chi square|23.02|||<|0.05|||||||Chi-squared|||||||<0.05
70978735|NCT00885079|141465268|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for change from baseline in the FCS score was determined by comparing the non-inferiority margin (0.4) with the upper limit of the confidence interval of the difference between the 2 treatment groups.|Mean Difference (Final Values)|-0.9|STANDARD_DEVIATION|2.1|<|0.05|TWO_SIDED|95.0|-1.47|-0.24||An analysis of change from baseline of FCS was performed using t-test. The level of singnificanse was 5 % (2-sided).|t-test, 2 sided|||||-0.24|-1.47|<0.05
70978736|NCT00885079|141465269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1|||<|0.05|||||||t-test, 2 sided|||||||<0.05
70978737|NCT02630953|141465273|SUPERIORITY||Median Difference (Final Values)|-6.22||||0.24|TWO_SIDED|95.0|-41.15|28.7||Significance level was set at .05 a priori.|quantile regression|Bootstrapped standard errors (10,000 replications)||Using a series of quantile regression models with bootstrapped standard errors (10,000 replications) we examined the potential treatment effects on MVPA at follow-ups, controlling for baseline. Quantile regression models the median outcome instead of the mean, and are appropriate when data is skewed (as was the case in both self-reported and objectively measured MVPA).||28.70|-41.15|0.24
70978738|NCT02630953|141465274|SUPERIORITY||Median Difference (Final Values)|7.5||||0.73|TWO_SIDED|95.0|-32.37|47.37||Significance was set at .05 a priori|quantile regression|||Using a series of quantile regression models with bootstrapped standard errors (10,000 replications) we examined the potential treatment effects on MVPA at follow-up, controlling for baseline||47.37|-32.37|0.73
70978739|NCT02630953|141465275|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.035|>|0.06|TWO_SIDED|||||Significance level set at .05 a priori|Regression, Linear|||Using a series of generalized linear models with identity link, we examined treatment effects on biomarkers at 6 months controlling for baseline and potential confounders.||||>.06
70978740|NCT01651780|141465284|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Relative Risk|0.77||||0.2692|TWO_SIDED|95.0|0.48|1.23|||Chi-squared|||||1.23|0.48|0.2692
70978741|NCT01651780|141465285|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Relative Risk|0.89||||0.4967|TWO_SIDED|95.0|0.64|1.24|||Chi-squared|||||1.24|0.64|0.4967
70978742|NCT03359902|141465322|SUPERIORITY||beta|1.4||||0.11|TWO_SIDED||||||Mixed Models Analysis|||"A linear mixed effects model was conducted to account for carryover and order effects in this crossover trial.~Assuming α = 0.05, two-sided test, and 60 participants in total. If the carryover effect is negligible, we will have 90% power to detect an effect size of 0.604 for memory improvement"||||0.11
70978743|NCT02930174|141465325|EQUIVALENCE|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|2.0||0.26|TWO_SIDED||||||ANOVA|||||||0.26
70978744|NCT02930174|141465326|EQUIVALENCE|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|2.0||0.342|TWO_SIDED||||||ANOVA|||||||0.342
70978745|NCT02930174|141465327|EQUIVALENCE|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|2.0||0.184|TWO_SIDED||||||ANOVA|||||||0.184
70978746|NCT02930174|141465328|EQUIVALENCE|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|2.0||0.283|TWO_SIDED||||||ANOVA|||||||0.283
70978747|NCT02930174|141465329|EQUIVALENCE|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|2.0||0.204|TWO_SIDED||||||ANOVA|||||||0.204
70978748|NCT02930174|141465330|EQUIVALENCE|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|2.0||0.136|TWO_SIDED||||||ANOVA|||||||0.136
71034760|NCT03086460|141578867|SUPERIORITY||Mean Difference (Final Values)|0.137|||<|0.001|TWO_SIDED|95.0|0.061|0.213|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.213|0.061|<0.001
70978749|NCT00151892|141465331|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A 2-sided 95% confidence interval (CI) for the difference in the percentages of subjects in remission at 6 months of the two treatment groups will be computed. Non-inferiority of SPD476 to Asacol will be concluded if the lower limit of the 95% CI lies above the non-inferiority margin of -10%.|Difference in proportions|0.02||||||95.0|-0.04|0.08||||||The null hypothesis to be tested is that the true difference in proportions is less than or equal to -10%.||0.08|-0.04|
70978750|NCT02901431|141465336|SUPERIORITY||Difference in Adjusted LSMeans|-0.16||||0.911|TWO_SIDED|90.0|-2.56|2.23|||Mixed Models Analysis|||||2.23|-2.56|0.911
70978751|NCT02901431|141465337|SUPERIORITY||Difference in adjused LSMean|0.29|||||TWO_SIDED|90.0|-1.85|2.43||||||Week 12||2.43|-1.85|
71034761|NCT03086460|141578867|SUPERIORITY||Mean Difference (Final Values)|0.151|||<|0.001|TWO_SIDED|95.0|0.078|0.223|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.223|0.078|<0.001
70978752|NCT02901431|141465337|SUPERIORITY||Difference in adjusted LSMean|-0.23|||||TWO_SIDED|90.0|-2.67|2.22||||||Week 24||2.22|-2.67|
70978753|NCT02901431|141465338|SUPERIORITY||Difference in adjusted LSMean|-0.22|||||TWO_SIDED|90.0|-2.36|1.92||||||Communication Domain Standard Score, Week 12||1.92|-2.36|
70978754|NCT02901431|141465338|SUPERIORITY||Difference in adjusted LSMean|0.71|||||TWO_SIDED|90.0|-1.6|3.02||||||Communication Domain Standard Score, Week 24||3.02|-1.60|
70978755|NCT02901431|141465338|SUPERIORITY||Difference in adjusted LSMean|0.51|||||TWO_SIDED|90.0|-2.1|3.12||||||Socialization Domain Standard Score, Week 12||3.12|-2.10|
70978756|NCT02901431|141465338|SUPERIORITY|Socialization Domain Standard Score, Week 24|Difference in adjusted LSMean|-0.61|||||TWO_SIDED|90.0|-3.74|2.51||||||||2.51|-3.74|
70978757|NCT02901431|141465338|SUPERIORITY|Daily Living Skills Domain Standard Score, Week 12|Difference in adjusted LSMean|2.14|||||TWO_SIDED|90.0|-0.63|4.9||||||||4.90|-0.63|
70978758|NCT02901431|141465338|SUPERIORITY|Daily Living Skills Domain Standard Score, Week 24|Differences in adjusted LSMean|0.18|||||TWO_SIDED|90.0|-2.87|3.22||||||||3.22|-2.87|
70978759|NCT02901431|141465344|SUPERIORITY||Difference of Adjusted LS Means|3.74|||||TWO_SIDED|90.0|0.78|6.7|||Mixed Models Analysis|||Week 12||6.70|0.78|
70978760|NCT02901431|141465344|SUPERIORITY||Difference of Adjusted LS means|2.28|||||TWO_SIDED|90.0|-0.73|5.29||||||Week 24||5.29|-0.73|
70978761|NCT02901431|141465346|SUPERIORITY||Difference in Adjusted LS Means|0.01||||0.992|TWO_SIDED|90.0|-1.99|2.01|||Mixed Models Analysis|||||2.01|-1.99|0.992
70978762|NCT01272583|141465348|SUPERIORITY_OR_OTHER|||||||1||95.0|||||ANOVA|The Friedman Test was used for ANOVA.||||||1.0
71034762|NCT03086460|141578867|SUPERIORITY||Mean Difference (Final Values)|0.168|||<|0.001|TWO_SIDED|95.0|0.097|0.24|||ANCOVA|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.240|0.097|<0.001
70978763|NCT01272583|141465349|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||GLP-1 intact|ANOVA|The Friedman Test was used for ANOVA||||||<0.001
70978764|NCT01272583|141465349|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||GLP-1 Total|ANOVA|The Friedman Test was used for ANOVA.||||||0.98
70978765|NCT01272583|141465349|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||GIP intact|ANOVA|The Friedman Test was used for ANOVA.||||||0.049
70978766|NCT01272583|141465349|SUPERIORITY_OR_OTHER|||||||0.44||95.0||||GIP total|ANOVA|The Friedman Test was used for ANOVA||||||0.44
71034763|NCT03086460|141578867|SUPERIORITY||Mean Difference (Final Values)|0.016||||0.679|TWO_SIDED|95.0|-0.061|0.093|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.093|-0.061|0.679
71034764|NCT03086460|141578867|SUPERIORITY||Mean Difference (Final Values)|0.023||||0.549|TWO_SIDED|95.0|-0.052|0.098|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.098|-0.052|0.549
71034765|NCT03086460|141578867|SUPERIORITY||Mean Difference (Final Values)|0.036||||0.323|TWO_SIDED|95.0|-0.036|0.109|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.109|-0.036|0.323
70978767|NCT01272583|141465350|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|The Friedman Test was used for ANOVA.||||||0.14
71034766|NCT03086460|141578867|SUPERIORITY||Mean Difference (Final Values)|0.007||||0.866|TWO_SIDED|95.0|-0.073|0.087|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.087|-0.073|0.866
70978768|NCT01272583|141465351|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||ANOVA|The Friedman Test was used for ANOVA.||||||0.98
70978769|NCT01272583|141465352|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANOVA|The Friedman Test was used for ANOVA.||||||0.22
70978770|NCT01272583|141465353|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|The Friedman Test was used for ANOVA.||||||0.01
70978771|NCT01272583|141465353|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Dunn's Multiple Comparison Test|Post Hoc testing||||||<0.05
70978772|NCT01272583|141465354|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|The Friedman Test was used for ANOVA.||||||0.76
70978773|NCT00484315|141465383|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the TAXUS Element stent was to be accepted if the Bayesian posterior probability that the difference in 12-month TLF between TAXUS Element and TAXUS Express was \< 4.1%, given the data, was at least 95%. The sample size of 1264 subjects (resulting in 1200 after accounting for 5% attrition) was determined through simulations based on Bayesian modeling.|Median Difference (Final Values)|-0.57|STANDARD_DEVIATION|0.0155||0.9996|ONE_SIDED|95.0||1.85||The p-value is the posterior probability that the difference in 12-month TLF between TAXUS Element and TAXUS Express was \< 4.1%, given the data observed.|Bayesian modeling||Values are based on the posterior distribution of the difference in TLF rates between TAXUS Element and TAXUS Express. The upper limit is the 1-Sided 95% posterior credible interval, based off the 95th percentile of the posterior distribution.|Bayesian modeling was used to determine if the 12-month TLF rate for the TAXUS Element stent was non-inferior to the 12-month TLF rate in the TAXUS Express2 control. The null hypothesis was that the TAXUS Element TLF rate is at least 4.1% greater than the TAXUS Express TLF rate. The alternative hypothesis was that the TAXUS Element TLF rate is less than 4.1% greater than the TAXUS Express TLF rate.||1.85||0.9996
71008526|NCT02140762|141525113|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|18.2|||||TWO_SIDED|||||||||Vaccine effectiveness\<60% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity strains in ABCWY)/(% of not killed strains/without bactericidal activity strains in ACWY)\*100\].||||
70978774|NCT00484315|141465384|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the TAXUS Element stent was to be accepted if the Bayesian posterior probability that the difference in mean ln(9-month percent diameter stenosis) between TAXUS Element and TAXUS Express was \< 0.20, given the data, was at least 95%. The sample size of 330 subjects (resulting in 280 after accounting for 15% attrition) was determined through simulations based on Bayesian modeling.|Mean Difference (Final Values)|-0.0294|STANDARD_DEVIATION|0.08253||0.997|ONE_SIDED|95.0||0.1078||P-value is posterior probability that the difference in mean ln(9-month percent diameter stenosis) between TAXUS Element and TAXUS Express was \< 0.20, given the data observed. Non-inferiority was concluded, as this probability is greater than 95%.|Bayesian modeling||Based on posterior distribution of the difference in mean ln(9-month percent diameter stenosis) between TAXUS Element and TAXUS Express. Upper limit is 1-Sided 95% posterior credible interval, based off the 95th percentile of posterior distribution.|Natural log (ln) transformation was used to improve normality of the secondary endpoint distribution. Bayesian modeling was used to determine if the mean ln(9-month percent diameter stenosis) for the TAXUS Element stent was non-inferior to the mean ln(9-month %DS) for TAXUS Express. Null hypothesis was that the TAXUS Element mean was at least 0.20 greater than the TAXUS Express mean. Alternative hypothesis was that the TAXUS Element mean is less than 0.20 greater than the TAXUS Express TLF mean.||0.1078||0.9970
70978775|NCT04672083|141465387|OTHER||||||<|0.05|||||||ANOVA|||"CPT31 dose proportionality will be examined across dose groups using a power model approach or ANOVA model, as appropriate.PK parameters will be analyzed using a power model that will have the following form: parameter = intercept × dose\^slope + random error.~Using the natural log (ln) transformation, a power model can be expressed as a linear regression equation: ln(parameter) = intercept + slope × ln(dose) + random error. For dose proportionality, the slope = 1; for dose independence, = 0."||||<0.05
70978776|NCT04672083|141465388|OTHER||||||<|0.05|||||||ANOVA|||"CPT31 dose proportionality will be examined across dose groups using a power model approach or ANOVA model, as appropriate.PK parameters will be analyzed using a power model that will have the following form: parameter = intercept × dose\^slope + random error.~Using the natural log (ln) transformation, a power model can be expressed as a linear regression equation: ln(parameter) = intercept + slope × ln(dose) + random error. For dose proportionality, the slope = 1; for dose independence, = 0."||||<0.05
70978777|NCT04672083|141465389|OTHER||||||<|0.05|||||||Regression, Linear|||The lack of fit test will be conducted for the statistical assessment of linearity assumption (AOL), and thus appropriateness of a power model. PK parameter is dose proportional if AOL is ruled acceptable and the 95% confidence interval for the slope spans 1. If the AOL is ruled unacceptable for any PK parameter, its corresponding PK parameter normalized by dose administered will be ln-transformed and analyzed using an analysis of variance (ANOVA) model. The model will include dose as a factor.||||<0.05
70978778|NCT04672083|141465390|OTHER||||||<|0.05|||||||Regression, Linear|||The lack of fit test will be conducted for the statistical assessment of linearity assumption (AOL), and thus appropriateness of a power model. PK parameter is dose proportional if AOL is ruled acceptable and the 95% CI for the slope spans 1. If the AOL is ruled unacceptable for any PK parameter, its corresponding PK parameter normalized by dose administered will be ln-transformed and analyzed using an analysis of variance (ANOVA) model. The model will include dose as a factor.||||<0.05
70978779|NCT04672083|141465391|OTHER||||||<|0.05|||||||Regression, Linear|||The lack of fit test will be conducted for the statistical assessment of linearity assumption (AOL), and thus appropriateness of a power model. PK parameter is dose proportional if AOL is ruled acceptable and the 95% CI for the slope spans 1. If the AOL is ruled unacceptable for any PK parameter, its corresponding PK parameter normalized by dose administered will be ln-transformed and analyzed using an analysis of variance (ANOVA) model. The model will include dose as a factor.||||<0.05
70978780|NCT04672083|141465392|OTHER||||||<|0.05|||||||Regression, Linear|||The lack of fit test will be conducted for the statistical assessment of linearity assumption (AOL), and thus appropriateness of a power model. PK parameter is dose proportional if AOL is ruled acceptable and the 95% CI for the slope spans 1. If the AOL is ruled unacceptable for any PK parameter, its corresponding PK parameter normalized by dose administered will be ln-transformed and analyzed using an analysis of variance (ANOVA) model. The model will include dose as a factor.||||<0.05
70978781|NCT04672083|141465393|OTHER||||||<|0.05|||||||Regression, Linear|||The lack of fit test will be conducted for the statistical assessment of linearity assumption (AOL), and thus appropriateness of a power model. PK parameter is dose proportional if AOL is ruled acceptable and the 95% CI for the slope spans 1. If the AOL is ruled unacceptable for any PK parameter, its corresponding PK parameter normalized by dose administered will be ln-transformed and analyzed using an analysis of variance (ANOVA) model. The model will include dose as a factor.||||<0.05
70978782|NCT04672083|141465394|OTHER||||||<|0.05|||||||Regression, Linear|||Concentrations for all subjects in Cohorts 1-3 were below the limit of quantification.||||<0.05
70978783|NCT04672083|141465395|OTHER||||||<|0.05|||||||Regression, Linear|||Concentrations for all subjects in Cohorts 1-3 were below the limit of quantitation||||<0.05
70978784|NCT04672083|141465396|OTHER||||||<|0.05|||||||Regression, Linear|||Concentrations for all subjects in Cohorts 1-3 were below the limit of quantitation||||<0.05
71034767|NCT03086460|141578867|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.596|TWO_SIDED|95.0|-0.055|0.096|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.096|-0.055|0.596
70978785|NCT04672083|141465397|OTHER||||||<|0.05|||||||Regression, Linear|||The lack of fit test will be conducted for the statistical assessment of linearity assumption (AOL), and thus appropriateness of a power model. PK parameter is dose proportional if AOL is ruled acceptable and the 95% CI for the slope spans 1. If the AOL is ruled unacceptable for any PK parameter, its corresponding PK parameter normalized by dose administered will be ln-transformed and analyzed using an analysis of variance (ANOVA) model. The model will include dose as a factor.||||<0.05
71034768|NCT03086460|141578867|SUPERIORITY|"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."|Mean Difference (Final Values)|0.014||||0.72|TWO_SIDED|95.0|-0.061|0.088|||ANCOVA|||||0.088|-0.061|0.720
71034769|NCT03086460|141578867|SUPERIORITY||Mean Difference (Final Values)|0.112||||0.003|TWO_SIDED|95.0|0.038|0.185|||ANCOVA|||"Day 14~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.185|0.038|0.003
71034770|NCT03086460|141578867|SUPERIORITY||Mean Difference (Final Values)|0.133|||<|0.001|TWO_SIDED|95.0|0.057|0.209|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.209|0.057|<0.001
71034771|NCT03086460|141578867|SUPERIORITY||Mean Difference (Final Values)|0.106||||0.005|TWO_SIDED|95.0|0.032|0.18|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.180|0.032|0.005
71096278|NCT02421510|141701423|SUPERIORITY||Least squares mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.058|<|0.001|TWO_SIDED|95.0|-0.48|-0.25||Threshold for significance \<= 0.05|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C-by-time interaction as a covariate.||-0.25|-0.48|< 0.001
70922486|NCT02376790|141336018|SUPERIORITY||LS Mean Treatment Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.85||0.56|TWO_SIDED|95.0|-2.16|1.16||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in Mental Component Summary at week 24||1.16|-2.16|0.56
70922487|NCT02376790|141336019|SUPERIORITY||LS Mean Treatment Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.24||0.02|TWO_SIDED|95.0|-1.03|-0.09||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||-0.09|-1.03|0.020
70922488|NCT02376790|141336019|SUPERIORITY||LS Mean Treatment Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.1|TWO_SIDED|95.0|-0.88|0.08||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||0.08|-0.88|0.10
70922489|NCT02376790|141336021|SUPERIORITY||LS Mean Treatment Difference|13.92|STANDARD_ERROR_OF_MEAN|33.23||0.68|TWO_SIDED|95.0|-51.52|79.36||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||79.36|-51.52|0.68
70922490|NCT02376790|141336021|SUPERIORITY||LS Mean Treatment Difference|6.34|STANDARD_ERROR_OF_MEAN|33.05||0.85|TWO_SIDED|95.0|-58.75|71.42||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||71.42|-58.75|0.85
70922491|NCT02376790|141336022|SUPERIORITY||Treatment Difference|12.9||||0.057|TWO_SIDED|95.0|-0.4|26.2||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|||26.2|-0.4|0.057
70922492|NCT02376790|141336022|SUPERIORITY||Treatment Difference|10.9||||0.12|TWO_SIDED|95.0|-2.5|24.4||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|||24.4|-2.5|0.12
70922493|NCT02376790|141336023|SUPERIORITY||LS Mean Treatment Difference|0.16|STANDARD_ERROR_OF_MEAN|0.42||0.7|TWO_SIDED|95.0|-0.66|0.98||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||0.98|-0.66|0.70
70922494|NCT02376790|141336023|SUPERIORITY||LS Mean Treatment Difference|0.04|STANDARD_ERROR_OF_MEAN|0.42||0.93|TWO_SIDED|95.0|-0.79|0.86||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||0.86|-0.79|0.93
70922495|NCT02376790|141336024|SUPERIORITY||Treatment Difference|3.2||||0.55|TWO_SIDED|95.0|-7.3|13.7||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|||13.7|-7.3|0.55
70922496|NCT02376790|141336024|SUPERIORITY||Treatment Difference|8.8||||0.11|TWO_SIDED|95.0|-1.9|19.4||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|||19.4|-1.9|0.11
70922497|NCT02376790|141336025|SUPERIORITY||LS Mean Treatment Difference|9.36|STANDARD_ERROR_OF_MEAN|4.33||0.031|TWO_SIDED|95.0|0.85|17.87||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||17.87|0.85|0.031
70922498|NCT02376790|141336025|SUPERIORITY||LS Mean Treatment Difference|3.02|STANDARD_ERROR_OF_MEAN|4.33||0.49|TWO_SIDED|95.0|-5.49|11.54||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||11.54|-5.49|0.49
70922499|NCT02376790|141336026|SUPERIORITY||LS Mean Treatment Difference|15.95|STANDARD_ERROR_OF_MEAN|4.55|<|0.001|TWO_SIDED|95.0|6.99|24.9||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of percent improvement from baseline in the percentage of BSA involved in psoriasis in the subgroup of participants with ≥ 10% BSA involvement at baseline.||24.90|6.99|<0.001
70978786|NCT01552343|141465435|SUPERIORITY_OR_OTHER|||||||0.0187||95.0||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Correlation - no adjustments||||0.0187
70978787|NCT01552343|141465435|SUPERIORITY_OR_OTHER|||||||0.0094||95.0||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Partial correlation - baseline # of voids||||0.0094
70978788|NCT01552343|141465435|SUPERIORITY_OR_OTHER|||||||0.0383||95.0||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Partial correlation - baseline NI total score||||0.0383
70978789|NCT01552343|141465435|SUPERIORITY_OR_OTHER|||||||0.0133||95.0||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Partial correlation - age category||||0.0133
70978790|NCT01552343|141465435|SUPERIORITY_OR_OTHER|||||||0.0128||95.0|||||t-test, 2 sided|The a priori threshold for statistical significance was 0.05.||Partial correlation - gender||||0.0128
70978791|NCT01552343|141465436|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.7|||||TWO_SIDED|95.0|2.7|18.8|||||Non-Responders - Responders|Nocturia Impact (NI) Total Score (Q1-Q11)||18.8|2.7|
70978792|NCT01552343|141465436|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-9.6|9.6|||||Non-Responders - Responders|Overall Impact Question (Q12)||9.6|-9.6|
70978793|NCT01552343|141465439|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.6||||0.1471|TWO_SIDED|95.0|-20.3|3.1||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Nocturia Impact (NI) Total Score: Screening||3.1|-20.3|0.1471
70978794|NCT01552343|141465439|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.6||||0.0318|TWO_SIDED|95.0|-26.0|-1.2||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Nocturia Impact (NI) Total Score: Baseline||-1.2|-26.0|0.0318
70978795|NCT01552343|141465439|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.8||||0.0463|TWO_SIDED|95.0|-31.2|-0.3||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Overall Impact Question (Q12): Screening||-0.3|-31.2|0.0463
71034772|NCT03086460|141578867|SUPERIORITY||Mean Difference (Final Values)|0.152|||<|0.001|TWO_SIDED|95.0|0.081|0.223|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.223|0.081|<0.001
70978796|NCT01552343|141465439|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.7||||0.0413|TWO_SIDED|95.0|-34.6|-0.7||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Overall Impact Question (Q12): Baseline||-0.7|-34.6|0.0413
70978797|NCT01552343|141465440|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.9647|TWO_SIDED|95.0|-6.6|6.3|||ANCOVA|Covariates baseline score, treatment and age stratum (\<65, \>=65).||Treatment effect. NI total scores are transformed to a 0-100 scale where 0 is good and 100 bad.||6.3|-6.6|0.9647
70978798|NCT00046228|141465501|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.551||95.0|0.67|1.23||The null hypothesis was tested at the significance level of 0.049. If it is significant, the significance level of null hypotheses tested in the analyses 2 and 3 will be adjusted according to the modified Hochberg approach.|Log Rank|Independent Clinical Endpoints Committee confirmed components of primary endpoint except for death \& resuscitated v fib assessed by the investigator)||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the primary PCI in terms of the primary efficacy outcome. Assuming the relative risk reduction for the reteplase/abciximab facilitated PCI group versus the Primary PCI group is 15% in lower risk, 25% in medium risk, and 35% in high risk, the power of this comparison (1,000 subjects per group) is 83.4 %.||1.23|0.67|0.551
70978799|NCT00046228|141465501|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.858||95.0|0.72|1.31|||Log Rank|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in terms of the primary efficacy outcome. Assuming the relative risk reduction for the Abciximab facilitated PCI versus the Primary PCI group is 12.7%, in lower risk, 17.9% in medium risk, and 25.0% in high risk, the power of this comparison (1000 subjects per group) is 54.1%||1.31|0.72|0.858
70978800|NCT00046228|141465501|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.676||95.0|0.69|1.27|||Log Rank|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in terms of the primary efficacy outcome. Assuming the relative risk reduction for the reteplase/abciximab facilitated PCI versus the abciximab facilitated PCI group is 2.6% in lower risk, 8.7% in medium risk, and 13.3% in high risk, the power of this comparison (1,000 subjects per group) is 13.5%.||1.27|0.69|0.676
71034773|NCT03086460|141578867|SUPERIORITY||Mean Difference (Final Values)|0.142|||<|0.001|TWO_SIDED|95.0|0.072|0.212|||ANCOVA|||"Day 14~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.212|0.072|<0.001
71034774|NCT03086460|141578867|SUPERIORITY||Mean Difference (Final Values)|0.021||||0.573|TWO_SIDED|95.0|-0.053|0.096|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.096|-0.053|0.573
70978801|NCT00046228|141465502|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.247||95.0|0.57|1.16|||Chi-squared|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the primary PCI in complications of MI within 90 days.||1.16|0.57|0.247
70978802|NCT00046228|141465502|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.278||95.0|0.58|1.17|||Chi-squared|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in complications of MI within 90 days.||1.17|0.58|0.278
70978803|NCT00046228|141465502|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.944||95.0|0.68|1.43|||Chi-squared|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in complications of MI within 90 days.||1.43|0.68|0.944
70978804|NCT00046228|141465503|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.494||95.0|0.74|1.84|||Chi-squared|||The null hypothesis is if retaplase/abciximab facilitated PCI is the same as the primary PCI in 90-day all cause mortality.||1.84|0.74|0.494
70978805|NCT00046228|141465503|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.338||95.0|0.79|1.95|||Chi-squared|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in 90-day all cause mortality.||1.95|0.79|0.338
70978806|NCT00046228|141465503|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.781||95.0|0.61|1.45|||Chi-squared|||The null hypothesis is if retaplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in 90-day all cause mortality.||1.45|0.61|0.781
70978807|NCT00046228|141465504|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.016||95.0|1.08|2.1|||Chi-squared|||The null hypothesis is if retaplase/abciximab facilitated PCI is the same as the primary PCI in ST-segment resolution \>70% from baseline.||2.10|1.08|0.016
70978808|NCT00046228|141465504|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.67||95.0|0.76|1.52|||Chi-squared|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in ST-segment resolution \>70% from baseline.||1.52|0.76|0.670
70978809|NCT00046228|141465504|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.042||95.0|1.01|1.93|||Chi-squared|||The null hypothesis is if retaplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in ST-segment resolution \>70% from baseline.||1.93|1.01|0.042
70978810|NCT00046228|141465505|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.603||95.0|0.62|1.32|||Log Rank|||||1.32|0.62|0.603
70978811|NCT00046228|141465505|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.765||95.0|0.73|1.52|||Log Rank|||||1.52|0.73|0.765
70978812|NCT00046228|141465505|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.415||95.0|0.59|1.24|||Log Rank|||||1.24|0.59|0.415
70978813|NCT00046228|141465506|SUPERIORITY_OR_OTHER|||||||0.218||95.0|||||Fisher Exact|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the primary PCI in the risk of ICH.||||0.218
70978814|NCT00046228|141465506|SUPERIORITY_OR_OTHER|||||||0.497||95.0|||||Fisher Exact|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in the risk of ICH.||||0.497
70978815|NCT00046228|141465506|SUPERIORITY_OR_OTHER|||||||0.062||95.0|||||Fisher Exact|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in the risk of ICH.||||0.062
70978816|NCT00046228|141465507|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.28|||<|0.001||95.0|1.63|3.19|||Fisher Exact|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the primary PCI in the risk of non-ICH TIMI bleeding events.||3.19|1.63|<0.001
70978817|NCT00046228|141465507|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.025||95.0|1.05|2.15|||Fisher Exact|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in the risk of non-ICH TIMI bleeding events.||2.15|1.05|0.025
71034775|NCT03086460|141578867|SUPERIORITY||Mean Difference (Final Values)|-0.006||||0.881|TWO_SIDED|95.0|-0.078|0.067|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.067|-0.078|0.881
71034776|NCT03086460|141578867|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.261|TWO_SIDED|95.0|-0.03|0.11|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.110|-0.030|0.261
70978818|NCT00046228|141465507|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.008||95.0|1.12|2.05|||Fisher Exact|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in the risk of non-ICH TIMI bleeding events.||2.05|1.12|0.008
70978819|NCT00046228|141465508|SUPERIORITY_OR_OTHER|||||||0.439||95.0|||||Fisher Exact|||||||0.439
70978820|NCT00046228|141465508|SUPERIORITY_OR_OTHER|||||||0.438||95.0|||||Fisher Exact|||||||0.438
70978821|NCT00046228|141465508|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.000
70978822|NCT00046228|141465509|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
70978823|NCT00046228|141465509|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Fisher Exact|||||||0.020
71034777|NCT03086460|141578867|SUPERIORITY||Mean Difference (Final Values)|-0.027||||0.493|TWO_SIDED|95.0|-0.104|0.051|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.051|-0.104|0.493
70978824|NCT00046228|141465509|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
70978825|NCT00046228|141465510|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.434||95.0|0.69|1.18|||Chi-squared|||||1.18|0.69|0.434
70978826|NCT00046228|141465510|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.589||95.0|0.71|1.22|||Chi-squared|||||1.22|0.71|0.589
70978827|NCT00046228|141465510|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.809||95.0|0.74|1.27|||Chi-squared|||||1.27|0.74|0.809
70978828|NCT04211337|141465511|SUPERIORITY||Hazard Ratio (HR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.165|0.475|||Log Rank|Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).|Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).|||0.475|0.165|<0.0001
70978829|NCT04211337|141465512|SUPERIORITY||Hazard Ratio (HR)|0.254|||<|0.0001|TWO_SIDED|95.0|0.153|0.423|||Log Rank|Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).|Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).|||0.423|0.153|<0.0001
70978830|NCT04211337|141465513|SUPERIORITY||Odds Ratio (OR)|3.7|||<|0.0001|TWO_SIDED|95.0|2.2|6.3||Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib)|Clopper-Pearson method|||||6.3|2.2|<0.0001
70978831|NCT04211337|141465514|SUPERIORITY||Hazard Ratio (HR)|0.275||||0.0004|TWO_SIDED|95.0|0.129|0.587|||Log Rank|Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).||||0.587|0.129|0.0004
70978832|NCT04211337|141465517|SUPERIORITY||Mean Difference (Final Values)|-0.16|||<|0.0001|TWO_SIDED|95.0|-0.23|-0.1||Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).|Wilcoxon (Mann-Whitney)|||||-0.10|-0.23|<0.0001
71034778|NCT03086460|141578867|SUPERIORITY||Mean Difference (Final Values)|0.019||||0.616|TWO_SIDED|95.0|-0.055|0.092|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.092|-0.055|0.616
71096279|NCT02421510|141701423|SUPERIORITY||Least squares mean difference|-0.35|||<|0.001|TWO_SIDED|95.0|-0.47|-0.24||Threshold for significance \<= 0.05|MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from Mixed effect Model Repeat Measurement (MMRM) model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C- by-time interaction as a covariate.||-0.24|-0.47|< 0.001
70978833|NCT04068103|141465534|SUPERIORITY|||||||0.98||||||P value \<= 0.35 moves trial to phase III, \>0.35 stops trial for futility. Decision rule calls for early stopping due to futility.|Fisher Exact|||One-sided Fisher's Exact Test of ctDNA clearance by treatment arm.||||0.98
70978834|NCT02732951|141465542|OTHER||Adjusted Mean|16.45|STANDARD_ERROR_OF_MEAN|16.45||0.3199|TWO_SIDED|95.0|-16.23|49.13|||Mixed model for repeated measurements|Kenward-Roger approximation was used for denominator degrees of freedom.|Fixed effects of treatment, prior anti-diabetic macular oedema treatment status, visit, treatment by visit interaction, baseline, baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within patient errors.|Null hypothesis = The CSFT change from baseline at Week 12 is equal in both groups||49.13|-16.23|0.3199
70978835|NCT03783195|141465621|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.59||0.4|TWO_SIDED|95.0|-1.77|0.76||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in liver fat as compared to high GRS group.||0.76|-1.77|0.40
70978836|NCT03783195|141465622|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.38|STANDARD_ERROR_OF_MEAN|0.93||0.71|TWO_SIDED|95.0|-3.33|2.57||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in liver fat as compared to high GRS group.||2.57|-3.33|0.71
70978837|NCT03783195|141465623|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-21.02|STANDARD_ERROR_OF_MEAN|4.8||0.0006|TWO_SIDED|95.0|-31.33|-10.72||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in VLDL-TG as compared to high GRS group.||-10.72|-31.33|0.0006
70978838|NCT03783195|141465624|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Median Difference (Net)|0.094|STANDARD_ERROR_OF_MEAN|0.17||0.59|TWO_SIDED|95.0|-0.27|0.46|||t-test, 2 sided|||This analysis focuses on the changes in the area under the curve (AUC) for measurements at different time points between the two GRS groups.||0.46|-0.27|0.59
70978839|NCT03783195|141465625|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-21.06|STANDARD_ERROR_OF_MEAN|7.77||0.017|TWO_SIDED|95.0|-37.75|-4.38||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in serum triglycerides as compared to high GRS group.||-4.38|-37.75|0.017
70978840|NCT03783195|141465626|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.022|STANDARD_ERROR_OF_MEAN|0.16||0.89|TWO_SIDED|95.0|-0.37|0.33|||t-test, 2 sided|||This analysis focuses on the changes in the area under the curve (AUC) for measurements baseline and 3hr timepoints at week 0 and week 3 between the two GRS groups.||0.33|-0.37|0.89
70978841|NCT03783195|141465627|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-4.36|STANDARD_ERROR_OF_MEAN|4.62||0.36|TWO_SIDED|95.0|-14.28|5.55||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have less increase in HDL cholesterol as compared to high GRS group.||5.55|-14.28|0.36
70978842|NCT03783195|141465628|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|0.067|STANDARD_ERROR_OF_MEAN|0.16||0.67|TWO_SIDED|95.0|-0.27|0.4|||t-test, 2 sided|||||0.40|-0.27|0.67
70978843|NCT03783195|141465629|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-21.03|STANDARD_ERROR_OF_MEAN|11.53||0.09|TWO_SIDED|95.0|-45.76|3.69||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in LDL cholesterol as compared to high GRS group.||3.69|-45.76|0.09
70978844|NCT03783195|141465630|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|0.054|STANDARD_ERROR_OF_MEAN|0.13||0.69|TWO_SIDED|95.0|-0.24|0.34|||t-test, 2 sided|||||0.34|-0.24|0.69
70978845|NCT03783195|141465631|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-29.61|STANDARD_ERROR_OF_MEAN|15.28||0.07|TWO_SIDED|95.0|-62.39|3.17||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in total cholesterol as compared to high GRS group.||3.17|-62.39|0.07
70978846|NCT03783195|141465632|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|0.036|STANDARD_ERROR_OF_MEAN|0.14||0.8|TWO_SIDED|95.0|-0.26|0.33|||t-test, 2 sided|||||0.33|-0.26|0.80
70978847|NCT03783195|141465633|OTHER||Mean Difference (Net)|0.36|STANDARD_ERROR_OF_MEAN|0.25||0.17|TWO_SIDED|95.0|-0.18|0.91||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in serum uric acid as compared to high GRS group.||0.91|-0.18|0.17
70978848|NCT03783195|141465634|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.217|STANDARD_ERROR_OF_MEAN|0.17||0.22|TWO_SIDED|95.0|-0.58|0.15|||t-test, 2 sided|||||0.15|-0.58|0.22
70978849|NCT03783195|141465635|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.007||0.04|TWO_SIDED|95.0|-0.03|-0.0009||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in serum ALT as compared to high GRS group.||-0.0009|-0.03|0.04
70978850|NCT03783195|141465636|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.121|STANDARD_ERROR_OF_MEAN|0.19||0.53|TWO_SIDED|95.0|-0.52|0.28|||t-test, 2 sided|||||0.28|-0.52|0.53
70978851|NCT03783195|141465637|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|20.57|STANDARD_ERROR_OF_MEAN|17.5||0.25|TWO_SIDED|95.0|-16.9|58.08||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in serum AST as compared to high GRS group.||58.08|-16.9|0.25
70978852|NCT03783195|141465638|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.17||0.2|TWO_SIDED|95.0|-0.59|0.13|||t-test, 2 sided|||||0.13|-0.59|0.20
70978853|NCT03783195|141465639|OTHER||Mean Difference (Net)|28.95|STANDARD_ERROR_OF_MEAN|21.78||0.21|TWO_SIDED|95.0|-17.76|75.67||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in serum ALP as compared to high GRS group.||75.67|-17.76|0.21
70978854|NCT03783195|141465640|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|0.054|STANDARD_ERROR_OF_MEAN|0.12||0.67|TWO_SIDED|95.0|-0.214|0.321|||t-test, 2 sided|||||0.321|-0.214|0.67
70978855|NCT03783195|141465641|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.09||0.41|TWO_SIDED|95.0|-0.12|0.28||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in serum GGT as compared to high GRS group.||0.28|-0.12|0.41
70978856|NCT03783195|141465642|OTHER|Both groups received the same intervention; however, their genetic make-up was different|Mean Difference (Net)|-0.109|STANDARD_ERROR_OF_MEAN|0.15||0.49|TWO_SIDED|95.0|-0.44|0.22|||t-test, 2 sided|||||0.22|-0.44|0.49
71034779|NCT03086460|141578867|SUPERIORITY||Mean Difference (Final Values)|0.046||||0.212|TWO_SIDED|95.0|-0.026|0.118|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.118|-0.026|0.212
70978857|NCT01903876|141465643|NON_INFERIORITY_OR_EQUIVALENCE|equivalence||||||0.044|||||||ANCOVA|||||||.044
70978858|NCT01903876|141465644|NON_INFERIORITY_OR_EQUIVALENCE|equivalence||||||0.042|||||||ANCOVA|||||||.042
70978859|NCT00450580|141465674|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority can be concluded if the lower bound of a two-sided 95% confidence interval for the difference in response rates between the two treatment arms is greater than -12%.|Risk Difference (RD)|-0.9||||||95.0|-11.4|9.5||||||||9.5|-11.4|
70978860|NCT00393718|141465682|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: Upper limit of confidence interval of mean difference(= Liraglutide - Glibenclamide) is less than 0.4%. Superiority criterion: Upper limit of confidence interval of mean difference(= Liraglutide - Glibenclamide) is less than 0.0%.|Least Squares Mean|-0.5|||<|0.0001||95.0|-0.7|-0.3||p-value is for the null hypothesis for superiority. A significance level of a one-sided 2.5% was used for statistical hypothesis testing.|ANOVA|||"ANOVA model included HbA1C at baseline as a covariate and treatment group and pre-trial treatment as fixed effects.~Hypothesis for non-inferiority:~H0: μ0.9 - μG ≥ 0.4, H1: μ0.9 - μG \< 0.4,~Hypothesis for superiority:~H0: μ0.9 - μG ≥ 0.0, H1: μ0.9 - μG \< 0.0, where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively. When non-inferiority was confirmed, superiority was evaluated based on the closed testing procedure."||-0.30|-0.70|<0.0001
70978861|NCT00393718|141465683|SUPERIORITY_OR_OTHER||Least Squares Mean|-0.49||||||95.0|-0.71|-0.27|||ANOVA|||95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-0.27|-0.71|
70978862|NCT00393718|141465684|SUPERIORITY_OR_OTHER||Least Squares Mean|-12.9|||<|0.0001||95.0|-18.2|-7.5||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.||-7.5|-18.2|<0.0001
71034780|NCT03086460|141578868|SUPERIORITY||Mean Difference (Final Values)|0.034||||0.361|TWO_SIDED|95.0|-0.039|0.106|||ANCOVA|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.106|-0.039|0.361
71034781|NCT03086460|141578868|SUPERIORITY||Mean Difference (Final Values)|0.065||||0.085|TWO_SIDED|95.0|-0.009|0.138|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.138|-0.009|0.085
71034782|NCT03086460|141578868|SUPERIORITY||Mean Difference (Final Values)|0.036||||0.328|TWO_SIDED|95.0|-0.037|0.109|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.109|-0.037|0.328
71034783|NCT03086460|141578868|SUPERIORITY||Mean Difference (Final Values)|0.112||||0.002|TWO_SIDED|95.0|0.042|0.182|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.182|0.042|0.002
71034784|NCT03086460|141578868|SUPERIORITY||Mean Difference (Final Values)|0.089||||0.011|TWO_SIDED|95.0|0.02|0.158|||ANCOVA|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.158|0.020|0.011
71034785|NCT03086460|141578868|SUPERIORITY||Mean Difference (Final Values)|0.031||||0.404|TWO_SIDED|95.0|-0.042|0.104|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.104|-0.042|0.404
71034786|NCT03086460|141578868|SUPERIORITY||Mean Difference (Final Values)|0.003||||0.942|TWO_SIDED|95.0|-0.069|0.074|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.074|-0.069|0.942
71034787|NCT03086460|141578868|SUPERIORITY||Mean Difference (Final Values)|0.078||||0.027|TWO_SIDED|95.0|0.009|0.147|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.147|0.009|0.027
70922500|NCT02376790|141336026|SUPERIORITY||LS Mean Treatment Difference|6.97|STANDARD_ERROR_OF_MEAN|4.5||0.12|TWO_SIDED|95.0|-1.89|15.83||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of percent improvement from baseline in the percentage of BSA involved in psoriasis in the subgroup of participants with ≥ 10% BSA involvement at baseline.||15.83|-1.89|0.12
70922501|NCT02376790|141336031|SUPERIORITY||Treatment Difference|11.4||||0.019|TWO_SIDED|95.0|2.0|20.8||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|||20.8|2.0|0.019
70922502|NCT02376790|141336031|SUPERIORITY||Treatment Difference|4.2||||0.4|TWO_SIDED|95.0|-5.6|14.0||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|||14.0|-5.6|0.40
70922503|NCT02376790|141336032|SUPERIORITY||Treatment Difference|20.1||||0.004|TWO_SIDED|95.0|6.8|33.3||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of percentage of participants with an sPGA of 0 or 1 at Week 24 in participants with baseline BSA involvement with psoriasis ≥ 10%.||33.3|6.8|0.004
70922504|NCT02376790|141336032|SUPERIORITY||Treatment Difference|17.1||||0.012|TWO_SIDED|95.0|4.0|30.2||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of percentage of participants with an sPGA of 0 or 1 at Week 24 in participants with baseline BSA involvement with psoriasis ≥ 10%.||30.2|4.0|0.012
70922505|NCT02272816|141336046|OTHER||Percentage|95.6|||||ONE_SIDED|95.0||98.6||||||||98.6||
70922506|NCT02272816|141336047|OTHER||Percentage|45.0|||||TWO_SIDED|95.0|30.2|59.9||||||||59.9|30.2|
70922507|NCT02272816|141336048|OTHER||Percentage|100.0|||||TWO_SIDED|95.0|92.6|100.0||||||||100|92.6|
70922508|NCT00976937|141336052|SUPERIORITY_OR_OTHER||Response rate difference|4.6|STANDARD_ERROR_OF_MEAN|3.28||0.1696|TWO_SIDED|95.0|-1.84|11.0||Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata of screening HbA1c (\<8.0 or \>=8.0%) and randomization strata of screening BMI (\<35 or \>=35 kg/m\^2) was used.|Cochran-Mantel-Haenszel|||To demonstrate the superiority of lixisenatide over sitagliptin, 150 patients in each arm would provide a power of 90% with a 2-sided test at the 5% significance level, assuming the percentage of patients defined as responders on HbA1c (\<7%) and weight (at least 5% loss) is 25% with lixisenatide and 10% with sitagliptin.||11.00|-1.84|0.1696
70922509|NCT01424670|141336088|SUPERIORITY|||||||0.0562||||||For testing the null hypothesis, the distribution of the time to SCC within the 6-month Intensive Period were compared between the 2 treatment groups using the stratified modified Peto-Peto modification of Gehan's Wilcoxon rank sum test.|Modified Peto-Peto test|||Comparison of distributions of time to SCC using the MGIT culture system during the 6-month (26-week) Intensive Period.||||0.0562
70922510|NCT01424670|141336089|SUPERIORITY|For testing the homogeneity of proportions, 2 samples were compared using the stratified Cochran-Mantel-Haenszel test.|Ratio of Probability|1.096||||0.3818|TWO_SIDED|95.0|0.889|1.352|||Cochran-Mantel-Haenszel||The stratified Cochran-Mantel-Haenszel test statistics were used for estimation.|Statistical comparison of proportion of participants with SCC at 2 months.||1.352|0.889|0.3818
70922511|NCT01424670|141336089|SUPERIORITY|For testing the homogeneity of proportions, 2 samples were compared using the stratified Cochran-Mantel-Haenszel test.|Ratio of Probability|1.017||||0.7131|TWO_SIDED|95.0|0.927|1.115|||Cochran-Mantel-Haenszel||The stratified Cochran-Mantel-Haenszel test statistics were used for estimation.|Statistical comparison of proportion of participants with SCC at 6 months.||1.115|0.927|0.7131
70922512|NCT01424670|141336090|SUPERIORITY||Relative Ratio of Probability|0.969||||0.5945|TWO_SIDED|95.0|0.866|1.084|||Cochran-Mantel-Haenszel|||Statistical comparison of proportion with sustained SCC at Month 18.||1.084|0.866|0.5945
70978863|NCT00393718|141465685|SUPERIORITY_OR_OTHER||Least Squares Mean|-11.7||||||95.0|-18.6|-4.9|||ANOVA|||95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-4.9|-18.6|
70978864|NCT00393718|141465686|SUPERIORITY_OR_OTHER||Least Squares Mean|-93.05|||<|0.0001||95.0|-119.61|-66.5||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.||-66.50|-119.61|<0.0001
70978865|NCT00393718|141465687|SUPERIORITY_OR_OTHER||Least Squares Mean|-74.51||||||95.0|-105.75|-43.27|||ANOVA|||95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-43.27|-105.75|
70978866|NCT00393718|141465688|SUPERIORITY_OR_OTHER||Least Squares Mean|-17.63|||<|0.0001||95.0|-25.0|-10.27||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.||-10.27|-25.00|<0.0001
70978867|NCT00393718|141465689|SUPERIORITY_OR_OTHER||Least Squares Mean|-17.21||||||95.0|-26.32|-8.09|||ANOVA|||95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-8.09|-26.32|
70978868|NCT00393718|141465690|SUPERIORITY_OR_OTHER||Least Squares Mean|-19.97|||<|0.0001||95.0|-27.99|-11.94||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.||-11.94|-27.99|<0.0001
70978869|NCT00393718|141465691|SUPERIORITY_OR_OTHER||Least Squares Mean|-13.03||||||95.0|-21.46|-4.6|||ANOVA|||95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-4.60|-21.46|
70978870|NCT00393718|141465692|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.91|||<|0.0001||95.0|-2.34|-1.48||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.||-1.48|-2.34|<0.0001
70978871|NCT00393718|141465693|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.71||||||95.0|-2.25|-1.18|||ANOVA|||95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-1.18|-2.25|
70978872|NCT00393718|141465694|SUPERIORITY_OR_OTHER||Rate ratio|0.2||||||95.0|0.12|0.35|||Negative binomial regression model|||The relative risk for 'All hypoglycaemic episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||0.35|0.12|
70978873|NCT00393718|141465694|SUPERIORITY_OR_OTHER||Rate ratio|0.18||||||95.0|0.09|0.36|||Negative binomial regression model|||The relative risk for 'Minor episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||0.36|0.09|
71034788|NCT03086460|141578868|SUPERIORITY||Mean Difference (Final Values)|-0.028||||0.463|TWO_SIDED|95.0|-0.104|0.048|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.048|-0.104|0.463
71034789|NCT03086460|141578868|SUPERIORITY||Mean Difference (Final Values)|0.047||||0.2|TWO_SIDED|95.0|-0.025|0.119|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.119|-0.025|0.200
71034790|NCT03086460|141578868|SUPERIORITY||Mean Difference (Final Values)|0.076||||0.037|TWO_SIDED|95.0|0.005|0.146|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.146|0.005|0.037
71034791|NCT03086460|141578869|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.896|TWO_SIDED|95.0|-0.083|0.073|||ANCOVA|||"Day 14~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.073|-0.083|0.896
71034792|NCT03086460|141578869|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.81|TWO_SIDED|95.0|-0.089|0.07|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.070|-0.089|0.810
71034793|NCT03086460|141578869|SUPERIORITY||Mean Difference (Final Values)|-0.006||||0.882|TWO_SIDED|95.0|-0.084|0.073|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.073|-0.084|0.882
71034794|NCT03086460|141578869|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.115|TWO_SIDED|95.0|-0.015|0.136|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.136|-0.015|0.115
70922513|NCT01424670|141336090|SUPERIORITY||Relative Ratio of Probability|0.97||||0.6164|TWO_SIDED|95.0|0.864|1.089|||Cochran-Mantel-Haenszel|||Statistical comparison of proportion with sustained SCC at Month 24.||1.089|0.864|0.6164
70922514|NCT01424670|141336090|SUPERIORITY||Relative Ratio of Probability|0.991||||0.8951|TWO_SIDED|95.0|0.872|1.127|||Cochran-Mantel-Haenszel|||Statistical comparison of proportion with sustained SCC at Month 30.||1.127|0.872|0.8951
70922515|NCT01424670|141336091|SUPERIORITY||Relative Ratio of Probability|0.965||||0.5269|TWO_SIDED|95.0|0.869|1.073|||Cochran-Mantel-Haenszel|||Statistical comparison of proportions with favorable treatment outcomes assessed by the Principal Investigator.||1.073|0.869|0.5269
70922516|NCT01424670|141336093|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.6986|TWO_SIDED|95.0|-1.9|1.3|||ANCOVA|||Statistical comparison of mean AUC of change from Baseline.||1.3|-1.9|0.6986
70922517|NCT01424670|141336094|SUPERIORITY|||||||0.6825|||||||ANCOVA|||Statistical analysis for Week 1.||||0.6825
70922518|NCT01424670|141336094|SUPERIORITY|||||||0.807|||||||ANCOVA|||Statistical analysis for Week 2.||||0.807
70922519|NCT01424670|141336094|SUPERIORITY|||||||0.269|||||||ANCOVA|||Statistical analysis for Week 3.||||0.269
70922520|NCT01424670|141336094|SUPERIORITY|||||||0.2333|||||||ANCOVA|||Statistical analysis for Week 24.||||0.2333
70922521|NCT01424670|141336094|SUPERIORITY|||||||0.9397|||||||ANCOVA|||Statistical analysis for Month 6.||||0.9397
70922522|NCT01424670|141336095|SUPERIORITY||Relative Ratio of Probability|0.991||||0.8951|TWO_SIDED|95.0|0.872|1.127|||Cochran-Mantel-Haenszel|||Statistical comparison of proportion with treatment success at Month 30.||1.127|0.872|0.8951
70922523|NCT02891915|141336103|SUPERIORITY|DOOR is a composite endpoint created using clinical outcomes from the first 5 days and at Outcome Assessment Visit #1 (OAV #1). It is based on adequate clinical response at OAV #1, solicited symptoms from first 5 days and number of days of antibiotics use for worsening pneumonia from the first 5 days of the study.|Pr (Higher DOOR in Short-Course)|0.69|||<|0.001|TWO_SIDED|95.0|0.63|0.75||Missing DOOR values at OAV #1 were first imputed using linear regression using baseline covariates and available DOOR components as covariates.|Wilcoxon (Mann-Whitney)|The Mann-Whitney test was run on the multiple imputed datasets to generate estimates of DOOR probability and p-value||Null: the sum of the probability that a subject assigned to the 5-day arm will have a higher DOOR (higher DOOR is a lower value and is superior) than if assigned to the 10-day arm plus one-half the probability of equal DOORs is 50% (i.e., no difference in DOOR).||0.75|0.63|<0.001
70922524|NCT02891915|141336104|SUPERIORITY|Testing whether Short course is superior to Standard course based on DOOR at OAV #2|Pr (Higher DOOR in Short-Course)|0.63|||<|0.001|TWO_SIDED|95.0|0.57|0.69||Missing DOOR values at OAV #2 were first imputed using linear regression using baseline covariates and available DOOR components as covariates|Wilcoxon (Mann-Whitney)|The Mann-Whitney test was run on the multiple imputed datasets to generate estimates of DOOR probability and p-value.||Null: the sum of the probability that a subject assigned to the 5-day arm will have a higher DOOR (higher DOOR is a lower numerical value and is superior) than if assigned to the 10-day arm plus one-half the probability of equal DOORs is 50% (i.e., no difference in DOOR).||0.69|0.57|<0.001
70922525|NCT00709098|141336119|SUPERIORITY_OR_OTHER||Mean group difference|-5.1|||<|0.0001|TWO_SIDED|95.0|-7.0|-3.1|||t-test, 2 sided|||||-3.1|-7.0|<0.0001
70922526|NCT01091168|141336135|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.673|TWO_SIDED|95.0|0.86|1.25|||Cochran-Mantel-Haenszel|||Kaplan-Meier curves and life tables by treatment arm were provided. Confidence intervals on the median were calculated using the Brookmeyer and Crowley method. Hazard ratio and 95% confidence intervals were reported. A stratified Cox proportional model was performed to compare the two treatment arms taking into account the stratification factors (except centre) used at the time of randomisation.||1.25|0.86|0.673
70922527|NCT01091168|141336136|SUPERIORITY|||||||0.0424|||||||Log Rank|||The disease control rate (DCR) were compared in the ITT population and in the population evaluable for response between the 2 arms with a cochran Mantel Haenszel, stratified on WHO performance status at baseline, number of prior chemotherapy lines for the treatment of disease and disease measurability at Baseline.||||0.0424
70922528|NCT01091168|141336137|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.4927|TWO_SIDED|95.0|0.8|1.12|||Log Rank|||PFS was compared between the 2 treatment arms by the log-rank test procedure with the 5 % significant level, stratified on the stratification factors (except study site) as specified at the time of randomisation. Os was analysed using Kaplan-Meir method and summarized with median and 95% CI of the median||1.12|0.8|0.4927
70922529|NCT04567615|141336177|SUPERIORITY||Strata adjusted difference in ORR|-2.7|||||TWO_SIDED|95.0|-10.7|5.3|||||Difference in ORR of Treatment B over ORR Treatment A|||5.3|-10.7|
70922530|NCT04567615|141336180|SUPERIORITY||Cox proportional hazard model|1.0|||||TWO_SIDED|95.0|0.75|1.33|||||HR of Treatment B over HR Treatment A|||1.33|0.75|
70922531|NCT04567615|141336181|SUPERIORITY||Strata adjusted difference in ORR|-0.9|||||TWO_SIDED|95.0|-9.2|7.4|||||Difference in ORR of Treatment B over ORR Treatment A|||7.4|-9.2|
70922532|NCT04567615|141336184|SUPERIORITY||Cox proportional hazard model|1.0|||||TWO_SIDED|95.0|0.75|1.33|||||HR of Treatment B over HR of Treatment A|||1.33|0.75|
70922533|NCT04567615|141336185|SUPERIORITY||Cox proportional hazard model|1.05|||||TWO_SIDED|95.0|0.74|1.49|||||HR of Treatment B over HR of Treatment A|||1.49|0.74|
70922534|NCT03481660|141336192|NON_INFERIORITY|(4-letter margin) (1-sided)|LS mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.94|<|0.001|TWO_SIDED|95.0|-0.6|3.1|||ANOVA|||BCVA at Week 52||3.1|-0.6|<0.001
70922535|NCT03481660|141336193|NON_INFERIORITY|(4-letter margin) (1-sided)|LS mean difference|0.9|STANDARD_ERROR_OF_MEAN|0.88|<|0.001|TWO_SIDED|95.0|-0.9|2.6|||ANOVA|||BCVA over period Week 40 through Week 52||2.6|-0.9|<0.001
70922536|NCT03481660|141336193|SUPERIORITY|||||||0.164|||||||ANOVA|||BCVA over period Week 40 through Week 52||||0.164
70922537|NCT03481660|141336200|OTHER|Treatment Difference|LS mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|95.0|-0.6|3.1||||||BCVA at Week 52||3.1|-0.6|
70922538|NCT03481660|141336200|OTHER|Treatment Difference|LS mean difference|2.6|STANDARD_ERROR_OF_MEAN|1.21|||TWO_SIDED|95.0|0.2|4.9||||||BCVA at Week 100||4.9|0.2|
70922539|NCT03481660|141336201|OTHER|Treatment difference|LS mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-0.6|2.1||||||BCVA over period Week 4 through Week 52||2.1|-0.6|
70978874|NCT00393718|141465694|SUPERIORITY_OR_OTHER||Rate ratio|0.2||||||95.0|0.11|0.34|||Negative binomial regression model|||The relative risk for 'Symptoms only' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||0.34|0.11|
70978875|NCT03293654|141465709|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25. The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.28|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.18|1.39|||||For the comparison, MB02 represents the numerator and US Avastin represents the denominator.|||1.39|1.18|
70978876|NCT03293654|141465709|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25. The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.12|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.03|1.22|||||For the comparison, MB02 represents the numerator and EU Avastin represents the denominator.|||1.22|1.03|
70978877|NCT03293654|141465709|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25. The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.14|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.05|1.24|||||Ratio of GLSM, EU is the numerator and US Avastin acts as the denominator|||1.24|1.05|
70978878|NCT03293654|141465710|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.16|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.09|1.22|||||||For the comparison, MB02 represents the numerator and US Avastin represents the denominator|1.22|1.09|
70978879|NCT03293654|141465710|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.16|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.09|1.22|||||MB02 represents the numerator and EU Avastin represents the denominator|||1.22|1.09|
70978880|NCT03293654|141465710|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.07|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.0|1.13|||||EU Avastin corresponds to the numerator and US Avastin corresponds to the denominator|||1.13|1|
70978881|NCT03293654|141465717|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.02|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.962|1.07|||||MB02 in numerator and EU Avastin in denominator|||1.07|0.962|
70978882|NCT03293654|141465717|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.06|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.996|1.13|||||MB02 is numerator and US Avastin is denominator|||1.13|0.996|
70978883|NCT03293654|141465717|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.04|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.983|1.11|||||EU Avastin in the numerator and US Avastin in the denominator|||1.11|0.983|
70978884|NCT03293654|141465718|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.02|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.969|1.07|||||MB02: EU Avastin|||1.07|0.969|
70978885|NCT03293654|141465718|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.06|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.998|1.12|||||MB02: US Avastin|||1.12|0.998|
70978886|NCT03293654|141465718|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.04|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.981|1.1|||||EU Avastin: US Avastin|||1.1|0.981|
70978887|NCT03293654|141465719|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|0.986|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.903|1.08|||||MB02: EU Avastin|||1.08|0.903|
71034795|NCT03086460|141578869|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.111|TWO_SIDED|95.0|-0.014|0.134|||ANCOVA|||"Day 14~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.134|-0.014|0.111
71034796|NCT03086460|141578869|SUPERIORITY||Mean Difference (Final Values)|-0.004||||0.911|TWO_SIDED|95.0|-0.083|0.074|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.074|-0.083|0.911
71034797|NCT03086460|141578869|SUPERIORITY||Mean Difference (Final Values)|-0.001||||0.985|TWO_SIDED|95.0|-0.078|0.077|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.077|-0.078|0.985
70922540|NCT03481660|141336201|OTHER|Treatment difference|LS mean difference|1.1|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|95.0|-0.4|2.6||||||BCVA over period Week 4 through Week 100||2.6|-0.4|
70922541|NCT03481660|141336202|OTHER|Treatment difference|LS mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|95.0|-0.9|2.4||||||BCVA over period Week 20 through Week 52||2.4|-0.9|
70922542|NCT03481660|141336202|OTHER|Treatment difference|LS mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|95.0|-0.9|2.5||||||BCVA over period Week 28 through Week 52||2.5|-0.9|
70922543|NCT03481660|141336202|OTHER|Treatment difference|LS mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.87|||TWO_SIDED|95.0|-0.5|2.9||||||BCVA over period Week 20 through Week 100||2.9|-0.5|
70922544|NCT03481660|141336202|OTHER|Treatment difference|LS mean difference|1.3|STANDARD_ERROR_OF_MEAN|0.89|||TWO_SIDED|95.0|-0.5|3.0||||||BCVA over period Week 28 through Week 100||3.0|-0.5|
70922545|NCT03481660|141336203|OTHER|Treatment difference|LS mean difference|2.1|STANDARD_ERROR_OF_MEAN|1.12|||TWO_SIDED|95.0|-0.1|4.3||||||BCVA over period Week 88 through Week 100||4.3|-0.1|
70922546|NCT03481660|141336204|OTHER|Treatment difference|Clopper-Pearson exact method|0.4|||||TWO_SIDED|95.0|-7.6|8.9||||||Gain of \>= 5 letters in BCVA at Week 52||8.9|-7.6|
70922547|NCT03481660|141336204|OTHER|Treatment difference|Clopper-Pearson exact method|5.4|||||TWO_SIDED|95.0|-3.9|14.5||||||Gain of \>= 5 letters in BCVA at Week 100||14.5|-3.9|
70922548|NCT03481660|141336205|OTHER|Treatment difference|Clopper-Pearson exact method|5.4|||||TWO_SIDED|95.0|-3.9|14.7||||||Gain of \>= 10 letters in BCVA at Week 52||14.7|-3.9|
70922549|NCT03481660|141336205|OTHER|Treatment difference|Clopper-Pearson exact method|9.9|||||TWO_SIDED|95.0|-0.4|19.4||||||Gain of \>= 10 letters in BCVA at Week 100||19.4|-0.4|
70922550|NCT03481660|141336206|OTHER|Treatment difference|Clopper-Pearson exact method|9.6|||||TWO_SIDED|95.0|-0.4|20.2||||||Gain of \>= 15 letters in BCVA at Week 52||20.2|-0.4|
70922551|NCT03481660|141336206|OTHER|Treatment difference|Clopper-Pearson exact method|13.6|||||TWO_SIDED|95.0|3.3|23.5||||||Gain of \>= 15 letters in BCVA at Week 100||23.5|3.3|
70922552|NCT03481660|141336207|OTHER|Treatment difference|Clopper-Pearson exact method|-0.4|||||TWO_SIDED|95.0|-4.2|2.9||||||Loss of \>= 5 letters in BCVA at Week 52||2.9|-4.2|
70922553|NCT03481660|141336207|OTHER|Treatment difference|Clopper-Pearson exact method|-6.0|||||TWO_SIDED|95.0|-10.8|-1.7||||||Loss of \>= 5 letters in BCVA at Week 100||-1.7|-10.8|
70922554|NCT03481660|141336208|OTHER|Treatment difference|Clopper-Pearson exact method|-0.2|||||TWO_SIDED|95.0|-3.2|2.4||||||Loss of \>= 10 letters in BCVA at Week 52||2.4|-3.2|
70922555|NCT03481660|141336208|OTHER|Treatment difference|Clopper-Pearson exact method|-4.1|||||TWO_SIDED|95.0|-8.4|-0.1||||||Loss of \>= 10 letters in BCVA at Week 100||-0.1|-8.4|
70922556|NCT03481660|141336209|OTHER|Treatment difference|Clopper-Pearson exact method|-0.7|||||TWO_SIDED|95.0|-3.2|1.6||||||Loss of \>= 15 letters in BCVA at Week 52||1.6|-3.2|
70922557|NCT03481660|141336209|OTHER|Treatment difference|Clopper-Pearson exact method|-1.3|||||TWO_SIDED|95.0|-4.8|2.0||||||Loss of \>= 15 letters in BCVA at Week 100||2.0|-4.8|
70922558|NCT03481660|141336210|OTHER|Treatment difference|Clopper-Pearson exact method|3.5|||||TWO_SIDED|95.0|-4.9|12.0||||||Absolute BCVA \>= 73 letters at Week 52||12.0|-4.9|
70922559|NCT03481660|141336210|OTHER|Treatment difference|Clopper-Pearson exact method|3.6|||||TWO_SIDED|95.0|-5.4|12.6||||||Absolute BCVA \>= 73 letters at Week 100||12.6|-5.4|
70922560|NCT03481660|141336212|OTHER|Treatment difference|LS mean difference|-29.4|STANDARD_ERROR_OF_MEAN|9.76|<|0.003|TWO_SIDED|95.0|-48.6|-10.2|||ANOVA|||CSFT over period Week 40 through Week 52||-10.2|-48.6|<0.003
70922561|NCT03481660|141336212|SUPERIORITY|||||||0.001|||||||ANOVA|||CSFT over period Week 40 through Week 52||||0.001
70922562|NCT03481660|141336212|OTHER|Treatment difference|LS mean difference|-23.2|STANDARD_ERROR_OF_MEAN|10.28|||TWO_SIDED|95.0|-43.5|-3.0||||||CSFT over period Week 88 through Week 100||-3.0|-43.5|
70922563|NCT03481660|141336213|OTHER|Treatment difference|LS mean difference|-27.4|STANDARD_ERROR_OF_MEAN|9.35|||TWO_SIDED|95.0|-45.8|-9.0||||||CSFT over period Week 4 through Week 52||-9.0|-45.8|
70922564|NCT03481660|141336213|OTHER|Treatment difference|LS mean difference|-25.8|STANDARD_ERROR_OF_MEAN|9.29|||TWO_SIDED|95.0|-44.0|-7.5||||||CSFT over period Week 4 through Week 100||-7.5|-44.0|
70922565|NCT03481660|141336214|OTHER|Treatment difference|Clopper-Pearson exact method|16.3|||||TWO_SIDED|95.0|5.7|25.9||||||CSFT thickness (\<280 micrometers) at Week 52||25.9|5.7|
70922566|NCT03481660|141336214|OTHER|Treatment difference|Clopper-Pearson exact method|14.7|||||TWO_SIDED|95.0|4.2|24.9||||||CSFT thickness (\<280 micrometers) at Week 100||24.9|4.2|
70922567|NCT03481660|141336215|OTHER||Clopper-Pearson exact method|-1.2|||||TWO_SIDED|95.0|-4.5|2.1||||||Subretinal Fluid (SRF) at Week 52||2.1|-4.5|
70922568|NCT03481660|141336215|OTHER|Treatment Difference|Clopper-Pearson exact method|-0.2|||||TWO_SIDED|95.0|-3.4|3.4||||||Subretinal Fluid (SRF) at Week 100||3.4|-3.4|
71096280|NCT02421510|141701424|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Percentage difference|16.3|||<|0.001|TWO_SIDED|95.0|9.17|23.43||Threshold for significance \<= 0.05|Cochran-Mantel-Haenszel||Sotagliflozin 200 mg versus Placebo|P-values were obtained from a Cochran-Mantel-Haenszel (CMH) test stratified by the different levels of the randomization stratification factors of insulin delivery method (MDI, CSII) and Week -2 A1C (\<=8.5%, \>8.5%). The 95% Confidence Limits (CL) were calculated using asymptotic Wald method. Only positively adjudicated severe hypoglycemia and diabetic ketoacidosis were included in the analysis.||23.43|9.17|< 0.001
71096281|NCT02421510|141701424|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Percentage difference|17.2|||<|0.001|TWO_SIDED|95.0|10.06|24.35||Threshold for significance \<= 0.05|Cochran-Mantel-Haenszel||Sotagliflozin 400 mg versus Placebo|P-values were obtained from a CMH test stratified by the different levels of the randomization stratification factors of insulin delivery method (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%). The 95% CL were calculated using asymptotic Wald method.||24.35|10.06|< 0.001
71096282|NCT02421510|141701425|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-1.98|STANDARD_ERROR_OF_MEAN|0.276|<|0.001|TWO_SIDED|95.0|-2.53|-1.44||Threshold for significance \<= 0.05|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects.||-1.44|-2.53|< 0.001
71096283|NCT02421510|141701425|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-2.58|STANDARD_ERROR_OF_MEAN|0.276|<|0.001|TWO_SIDED|95.0|-3.12|-2.04|||MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects.||-2.04|-3.12|< 0.001
70922569|NCT03481660|141336216|OTHER|Treatment Difference|Clopper-Pearson exact method|-19.1|||||TWO_SIDED|95.0|-28.9|-9.2||||||Intraretinal Fluid (IRF) at Week 52||-9.2|-28.9|
70922570|NCT03481660|141336216|OTHER|Treatment Difference|Clopper-Pearson exact method|-16.1|||||TWO_SIDED|95.0|-26.3|-5.7||||||Intraretinal Fluid (IRF) at Week 100||-5.7|-26.3|
70978888|NCT03293654|141465719|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.1|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.01|1.19|||||MB02: US Avastin|||1.19|1.01|
70922571|NCT03481660|141336217|OTHER|Treatment Difference|Clopper-Pearson exact method|-18.4|||||TWO_SIDED|95.0|-28.5|-8.3||||||Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) at Week 52||-8.3|-28.5|
70922572|NCT03481660|141336217|OTHER|Treatment difference|Clopper-Pearson exact method|-16.2|||||TWO_SIDED|95.0|-26.4|-5.9||||||Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) at Week 100||-5.9|-26.4|
70922573|NCT03481660|141336218|OTHER|Treatment difference|Clopper-Pearson exact method|-25.4|||||TWO_SIDED|95.0|-34.4|-16.3||||||Fluorescein Angiography (FA) at Week 52||-16.3|-34.4|
70922574|NCT03481660|141336218|OTHER|Treatment difference|Clopper-Pearson exact method|-19.1|||||TWO_SIDED|95.0|-29.1|-8.2||||||Fluorescein Angiography (FA) at Week 100||-8.2|-29.1|
70922575|NCT03481660|141336219|OTHER|Treatment difference|Clopper-Pearson exact method|1.1|||||TWO_SIDED|95.0|-5.6|7.8||||||\>=2-step improvement in ETDRS-DRSS at Week 52||7.8|-5.6|
70922576|NCT03481660|141336219|OTHER|Treatment difference|Clopper-Pearson exact method|4.5|||||TWO_SIDED|95.0|-1.7|10.8||||||\>=2-step improvement in ETDRS-DRSS at Week 100||10.8|-1.7|
70922577|NCT03481660|141336220|OTHER|Treatment difference|Clopper-Pearson exact method|-0.6|||||TWO_SIDED|95.0|-7.1|5.7||||||\>=3-step improvement in ETDRS-DRSS at Week 52||5.7|-7.1|
70922578|NCT03481660|141336220|OTHER|Treatment difference|Clopper-Pearson exact method|3.9|||||TWO_SIDED|95.0|-2.3|10.0||||||\>=3-step improvement in ETDRS-DRSS at Week 100||10.0|-2.3|
70922579|NCT03481660|141336221|OTHER|Treatment difference|Clopper-Pearson exact method|1.1|||||TWO_SIDED|95.0|-1.0|3.6||||||\>=2-step worsening in ETDRS-DRSS at Week 52||3.6|-1.0|
70922580|NCT03481660|141336221|OTHER|Treatment difference|Clopper-Pearson exact method|2.9|||||TWO_SIDED|95.0|-0.5|6.9||||||\>=2-step worsening in ETDRS-DRSS at Week 100||6.9|-0.5|
70922581|NCT03481660|141336222|OTHER|Treatment difference|Clopper-Pearson exact method|0.6|||||TWO_SIDED|95.0|0.5|2.1||||||\>=3-step worsening in ETDRS-DRSS at Week 52||2.1|0.5|
70922582|NCT03481660|141336222|OTHER|Treatment difference|Clopper-Pearson exact method|-0.6|||||TWO_SIDED|95.0|-2.6|1.3||||||\>=3-step worsening in ETDRS-DRSS at Week 100||1.3|-2.6|
70922583|NCT03481660|141336223|OTHER|Treatment difference|Clopper-Pearson exact method|0.0|||||TWO_SIDED|95.0|-2.1|1.9||||||Proliferative diabetic retinopathy (PDR) of at least 61 by Week 100||1.9|-2.1|
70922584|NCT03012841|141336243|SUPERIORITY|The formal alternative hypothesis test for the primary effectiveness objective was that the Kaplan-Meier estimator of treatment success at 12 months (365 days) was greater than 40%, against the null hypothesis that it was less than or equal to 40%.|Kaplan-Meier (product-limit) estimator|54.8|||<|0.001|TWO_SIDED|95.0|46.7|62.1|||Exact binomial|Exact binomial p-value is shown, but the confidence intervals reported are calculated from Greenwood's approximation of the standard error.||||62.1|46.7|<0.001
70922585|NCT03012841|141336244|SUPERIORITY|The formal alternative hypothesis tested for the primary safety objective was that the Kaplan-Meier estimator of the proportion of subjects with primary safety events at 12 months (365 days) was less than 13%, against the null hypothesis that it was greater than or equal to 13%.|Kaplan-Meier (product-limit) estimator|0.6||||0.002|TWO_SIDED|95.0|0.1|4.4|||Exact binomial|Exact binomial p-value is shown, but the confidence intervals reported are calculated from Greenwood's approximation of the standard error.||||4.4|0.1|0.002
70922586|NCT03012841|141336245|SUPERIORITY||Mean Difference (Net)|25.8|||<|0.001|TWO_SIDED|95.0|22.1|29.5||A Hommel multiple testing procedure was utilized to maintain overall alpha of 0.025 for the 3 hypotheses tested for the secondary objective.|t-test, 1 sided|||The formal alternative hypothesis tested was that the mean 12-month change in AFEQT composite scores was greater than 0, against the null the hypothesis that it was equal to 0.||29.5|22.1|<0.001
70922587|NCT03012841|141336246|SUPERIORITY||Mean Difference (Net)|5.0|||<|0.001|TWO_SIDED|95.0|3.5|6.5||A Hommel multiple testing procedure was utilized to maintain overall alpha of 0.025 for the 3 hypotheses tested for the secondary objective.|t-test, 1 sided|||The formal alternative hypothesis tested was that the mean 12-month change in SF-12 physical composite scores was greater than 0, against the null the hypothesis that it was equal to 0.||6.5|3.5|<0.001
70922588|NCT03012841|141336247|SUPERIORITY||Mean Difference (Net)|4.9|||<|0.001|TWO_SIDED|95.0|3.2|6.6||A Hommel multiple testing procedure was utilized to maintain overall alpha of 0.025 for the 3 hypotheses tested for the secondary objective.|t-test, 1 sided|||The formal alternative hypothesis tested was that the mean 12-month change in SF-12 mental composite scores was greater than 0, against the null the hypothesis that it was equal to 0.||6.6|3.2|<0.001
70922589|NCT03683069|141336248|SUPERIORITY|||||||0.823|||||||Regression, Linear|||adjusted to medication dose, sex, age, race||||0.823
70922590|NCT03683069|141336248|SUPERIORITY|||||||0.839|||||||Regression, Linear|||diastolic bp adjusted for medication dose sex,age, race||||.8390
70922591|NCT03683069|141336249|SUPERIORITY|||||||0.0101|||||||Wilcoxon (Mann-Whitney)|||||||.0101
70922592|NCT03683069|141336250|SUPERIORITY|||||||0.59|||||||ANOVA|||||||0.59
70922593|NCT03683069|141336251|SUPERIORITY||Hazard Ratio, log|0.7022||||0.09|TWO_SIDED||||||Kaplan-Meier using Gehan-Breslow-Wilcoxo|||||||.09
70922594|NCT04065048|141336260|OTHER|||||||0.469|||||||t-test, 2 sided|||||||0.469
70922595|NCT04065048|141336261|OTHER|||||||0.0093|||||||ANOVA|||||||0.0093
70922596|NCT04065048|141336263|OTHER|||||||0.2487|||||||Fisher Exact|||||||0.2487
70978889|NCT03293654|141465719|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.12|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.02|1.22|||||EU Avastin: US Avastin|||1.22|1.02|
70922597|NCT04491968|141336266|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.02|TWO_SIDED|95.0|0.37|0.9|||proportional hazard regression|||||.90|.37|.02
70922598|NCT04491968|141336267|SUPERIORITY||Hazard Ratio (HR)|0.41||||0.04|TWO_SIDED|95.0|0.18|0.96|||proportional hazard regression|||||.96|.18|.04
70922599|NCT05857644|141336275|OTHER||Geometric mean ratio|84.33|||||TWO_SIDED|90.0|50.94|139.59|||||Mild Hepatic Impairment versus No Hepatic Impairment|||139.59|50.94|
70922600|NCT05857644|141336275|OTHER||Geometric mean ratio|90.89|||||TWO_SIDED|90.0|54.91|150.45|||||Moderate Hepatic Impairment versus No Hepatic Impairment|||150.45|54.91|
70922601|NCT05857644|141336275|OTHER||Geometric mean ratio|157.23|||||TWO_SIDED|90.0|84.81|291.49|||||Severe Hepatic Impairment versus No Hepatic Impairment|||291.49|84.81|
70922602|NCT05857644|141336276|OTHER||Geometric mean ratio|82.17|||||TWO_SIDED|90.0|49.24|137.11|||||Mild Hepatic Impairment versus No Hepatic Impairment|||137.11|49.24|
70922603|NCT05857644|141336276|OTHER||Geometric mean ratio|130.82|||||TWO_SIDED|90.0|78.4|218.3|||||Moderate Hepatic Impairment versus No Hepatic Impairment|||218.30|78.40|
70922604|NCT05857644|141336276|OTHER||Geometric mean ratio|385.52|||||TWO_SIDED|90.0|205.92|721.77|||||Severe Hepatic Impairment versus No Hepatic Impairment|||721.77|205.92|
70922605|NCT05857644|141336277|OTHER||Geometric mean ratio|82.99|||||TWO_SIDED|90.0|50.53|136.28|||||Mild Hepatic Impairment versus No Hepatic Impairment|||136.28|50.53|
70922606|NCT05857644|141336277|OTHER||Geometric mean ratio|131.52|||||TWO_SIDED|90.0|80.09|215.99|||||Moderate Hepatic Impairment versus No Hepatic Impairment|||215.99|80.09|
70922607|NCT05857644|141336277|OTHER||Geometric mean ratio|392.1|||||TWO_SIDED|90.0|213.57|719.85|||||Severe Hepatic Impairment versus No Hepatic Impairment|||719.85|213.57|
70922608|NCT05307978|141336305|SUPERIORITY||Ratio (%)|68.729|||||TWO_SIDED|95.0|52.74|89.56|||Mixed Models Analysis|A mixed effect model was performed to the ln-transformed PK parameter and the independent variables.||||89.56|52.74|
70922609|NCT05307978|141336306|SUPERIORITY||Ratio (%)|120.043|||||TWO_SIDED|95.0|67.2|214.43|||Mixed Models Analysis|A mixed effect model was performed with ethnicity as fixed effect and participant as random effect.||||214.43|67.20|
70922610|NCT05307978|141336307|SUPERIORITY||Ratio (%)|118.142|||||TWO_SIDED|95.0|73.93|188.8|||Mixed Models Analysis|A mixed effect model was performed with ethnicity as fixed effect and participant as random effect.||||188.80|73.93|
70922611|NCT05307978|141336308|SUPERIORITY||Ratio (%)|93.891|||||TWO_SIDED|95.0|63.17|139.56|||Mixed Models Analysis|A mixed effect model was performed with ethnicity as fixed effect and participant as random effect.||||139.56|63.17|
70922612|NCT05075408|141336324|SUPERIORITY|Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.|Strata adjusted percentage difference|7.0||||0.3696|TWO_SIDED|97.5|-10.6|24.6||Threshold of significance at 0.025.|Cochran-Mantel-Haenszel|||Nemolizumab 30 mg versus Placebo||24.6|-10.6|0.3696
70922613|NCT05075408|141336324|SUPERIORITY|Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.|Strata adjusted percentage difference|14.5||||0.0686|TWO_SIDED|97.5|-3.1|32.2||Threshold of significance at 0.025.|Cochran-Mantel-Haenszel|||Nemolizumab 60 mg versus Placebo||32.2|-3.1|0.0686
70978890|NCT00868790|141465819|SUPERIORITY_OR_OTHER||Least Squares Mean (LSM) Difference|-17.2||||0.013|TWO_SIDED|90.0|-28.3|-6.1|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-6.1|-28.3|0.013
70978891|NCT00868790|141465819|SUPERIORITY_OR_OTHER||LSM Difference|-23.4|||<|0.001|TWO_SIDED|90.0|-34.5|-12.4|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-12.4|-34.5|<0.001
70978892|NCT00868790|141465819|SUPERIORITY_OR_OTHER||LSM Difference|-34.9|||<|0.001|TWO_SIDED|95.0|-44.8|-25.0|||LDA Model|Between-group difference (metformin-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-25.0|-44.8|<0.001
70978893|NCT00868790|141465820|SUPERIORITY_OR_OTHER||LSM Difference|-11.5||||0.002|TWO_SIDED|90.0|-17.5|-5.4|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-5.4|-17.5|0.002
70978894|NCT00868790|141465820|SUPERIORITY_OR_OTHER||LSM Difference|-21.8|||<|0.001|TWO_SIDED|90.0|-27.8|-15.8|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-15.8|-27.8|<0.001
70978895|NCT00868790|141465820|SUPERIORITY_OR_OTHER||LSM Difference|-36.0|||<|0.001|TWO_SIDED|90.0|-42.0|-30.0|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-30.0|-42.0|<0.001
70978896|NCT00868790|141465820|SUPERIORITY_OR_OTHER||LSM Difference|-20.0||||0.001|TWO_SIDED|90.0|-30.0|-10.1|||LDA Model|Between-group difference (metformin-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-10.1|-30.0|0.001
70978897|NCT00868790|141465821|SUPERIORITY_OR_OTHER||LSM Difference|-14.9||||0.174|TWO_SIDED|90.0|-33.0|3.2|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||3.2|-33.0|0.174
70978898|NCT00868790|141465821|SUPERIORITY_OR_OTHER||LSM Difference|-20.4||||0.063|TWO_SIDED|90.0|-38.4|-2.4|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-2.4|-38.4|0.063
70978899|NCT00868790|141465821|SUPERIORITY_OR_OTHER||LSM Difference|-78.1|||<|0.001|TWO_SIDED|90.0|-96.4|-59.8|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-59.8|-96.4|<0.001
71008757|NCT02055976|141525250|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-13.83|STANDARD_ERROR_OF_MEAN|9.326||0.071|TWO_SIDED|95.0|-32.368|4.709|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||4.709|-32.368|0.071
71008758|NCT02055976|141525250|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.378|STANDARD_ERROR_OF_MEAN|9.464||0.361|TWO_SIDED|95.0|-22.191|15.435|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||15.435|-22.191|0.361
70922614|NCT05075408|141336325|SUPERIORITY||Strata adjusted percentage difference|4.3||||0.5909|TWO_SIDED|97.5|-13.8|22.3|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||22.3|-13.8|0.5909
71034798|NCT03086460|141578869|SUPERIORITY||Mean Difference (Final Values)|0.066||||0.084|TWO_SIDED|95.0|-0.009|0.14|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.140|-0.009|0.084
71034799|NCT03086460|141578869|SUPERIORITY||Mean Difference (Final Values)|0.004||||0.928|TWO_SIDED|95.0|-0.078|0.086|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.086|-0.078|0.928
71034800|NCT03086460|141578869|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.078|TWO_SIDED|95.0|-0.008|0.148|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.148|-0.008|0.078
70922615|NCT05075408|141336325|SUPERIORITY||Strata adjusted percentage difference|12.9||||0.1112|TWO_SIDED|97.5|-5.5|31.4|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||31.4|-5.5|0.1112
70922616|NCT05075408|141336326|SUPERIORITY||Strata adjusted percentage difference|17.3||||0.0034|TWO_SIDED|97.5|4.3|30.4|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||30.4|4.3|0.0034
70922617|NCT05075408|141336326|SUPERIORITY||Strata adjusted percentage difference|17.1||||0.0025|TWO_SIDED|97.5|4.5|29.8|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||29.8|4.5|0.0025
70922618|NCT05075408|141336327|SUPERIORITY||Strata adjusted percentage difference|3.7||||0.5788|TWO_SIDED|97.5|-12.5|19.8|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||19.8|-12.5|0.5788
70922619|NCT05075408|141336327|SUPERIORITY||Strata adjusted percentage difference|16.5||||0.0303|TWO_SIDED|97.5|-0.8|33.9|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||33.9|-0.8|0.0303
70922620|NCT05075408|141336328|SUPERIORITY||Strata adjusted percentage difference|24.2||||0.0006|TWO_SIDED|97.5|8.8|39.6|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||39.6|8.8|0.0006
70922621|NCT05075408|141336328|SUPERIORITY||Strata adjusted percentage difference|20.8||||0.0021|TWO_SIDED|97.5|6.0|35.7|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||35.7|6.0|0.0021
70922622|NCT05075408|141336329|SUPERIORITY||Strata adjusted percentage difference|14.0||||0.0028|TWO_SIDED|97.5|3.8|24.1|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||24.1|3.8|0.0028
70922623|NCT05075408|141336329|SUPERIORITY||Strata adjusted percentage difference|19.0||||0.0003|TWO_SIDED|97.5|7.6|30.5|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||30.5|7.6|0.0003
70922624|NCT04878354|141336342|SUPERIORITY||Mean Difference (Final Values)|1.29||||0.0004|TWO_SIDED|95.0|0.58|2.0|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Adjusted p-value.||2.00|0.58|0.0004
70922625|NCT04878354|141336343|SUPERIORITY||Mean Difference (Final Values)|0.85||||0.001|TWO_SIDED|95.0|0.34|1.35|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Adjusted p-value.||1.35|0.34|0.0010
71034801|NCT03086460|141578869|SUPERIORITY||Mean Difference (Final Values)|0.066||||0.089|TWO_SIDED|95.0|-0.01|0.143|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.143|-0.010|0.089
71034802|NCT03086460|141578870|SUPERIORITY||Hazard Ratio (HR)|18.01|||<|0.001|TWO_SIDED|95.0|4.25|76.37|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Time to onset of action was analyzed using a Cox proportional hazard model stratified by patient, including treatment and period as a factor, and baseline FEV1 as covariate.~For patients receiving the same treatment twice, the analysis includes only data from the first instance of each treatment."||76.37|4.25|<0.001
70922626|NCT04878354|141336344|SUPERIORITY||Mean Difference (Final Values)|0.37||||0.0354|TWO_SIDED|95.0|0.03|0.71|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Adjusted p-value.||0.71|0.03|0.0354
70922627|NCT04878354|141336345|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.0734|TWO_SIDED|95.0|-0.02|0.5|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Adjusted p-value.||0.50|-0.02|0.0734
70922628|NCT04878354|141336346|SUPERIORITY||Mean Difference (Final Values)|0.86|||<|0.0001|TWO_SIDED|95.0|0.45|1.28|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||1.28|0.45|<0.0001
70922629|NCT04878354|141336347|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.0002|TWO_SIDED|95.0|0.26|0.82|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.82|0.26|0.0002
70922630|NCT04878354|141336348|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.1516|TWO_SIDED|95.0|-0.11|0.76|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.76|-0.11|0.1516
70922631|NCT04878354|141336349|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9709|TWO_SIDED|95.0|-0.24|0.25|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.25|-0.24|0.9709
70922632|NCT04878354|141336350|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.0499|TWO_SIDED|95.0|0.0|0.41|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.41|0.00|0.0499
70922633|NCT04878354|141336351|SUPERIORITY||Median Difference (Final Values)|1.45|||<|0.0001|TWO_SIDED|95.0|0.73|2.18|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||2.18|0.73|<0.0001
70922634|NCT04878354|141336352|SUPERIORITY||Median Difference (Final Values)|0.48||||0.0075|TWO_SIDED|95.0|0.13|0.83|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.83|0.13|0.0075
70922635|NCT04878354|141336353|SUPERIORITY||Median Difference (Final Values)|0.87|||<|0.0001|TWO_SIDED|95.0|0.44|1.29|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||1.29|0.44|<0.0001
70922636|NCT04878354|141336354|SUPERIORITY||Odds Ratio (OR)|1.2|||<|0.0001|TWO_SIDED|95.0|1.1|1.32|||Generalised linear mixed model (GLMM)||Odds ratio is (odds placebo SLIT-tablet / odds tree SLIT-tablet)|The odds of having a severe day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model includes proportion of severe days as the response variable and treatment, cohort, and age group as fixed effects and pollen station as random effect. Observed p-value.||1.32|1.10|<0.0001
71034803|NCT03086460|141578870|SUPERIORITY||Hazard Ratio (HR)|31.67|||<|0.001|TWO_SIDED|95.0|7.52|133.47|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||133.47|7.52|<0.001
71034804|NCT03086460|141578870|SUPERIORITY||Hazard Ratio (HR)|44.24|||<|0.001|TWO_SIDED|95.0|10.23|191.34|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||191.34|10.23|<0.001
71034805|NCT03086460|141578870|SUPERIORITY||Hazard Ratio (HR)|40.32|||<|0.001|TWO_SIDED|95.0|9.54|170.45|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||170.45|9.54|<0.001
71034806|NCT03086460|141578870|SUPERIORITY||Hazard Ratio (HR)|22.91|||<|0.001|TWO_SIDED|95.0|5.7|92.06|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||92.06|5.70|<0.001
71034807|NCT03086460|141578870|SUPERIORITY||Hazard Ratio (HR)|1.76||||0.195|TWO_SIDED|95.0|0.75|4.13|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||4.13|0.75|0.195
71034808|NCT03086460|141578870|SUPERIORITY||Risk Ratio (RR)|2.46||||0.037|TWO_SIDED|95.0|1.06|5.72|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||5.72|1.06|0.037
71096284|NCT02421510|141701426|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-3.2|STANDARD_ERROR_OF_MEAN|0.847|<|0.001|TWO_SIDED|95.0|-4.86|-1.53||Threshold for significance \<=0.05|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline mean daily bolus insulin dose-by-time interaction as a covariate.||-1.53|-4.86|< 0.001
71096285|NCT02421510|141701426|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-3.59|STANDARD_ERROR_OF_MEAN|0.845|<|0.001|TWO_SIDED|95.0|-5.25|-1.93||Threshold for significance \<= 0.05|MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline mean daily bolus insulin dose-by-time interaction as a covariate.||-1.93|-5.25|< 0.001
71096286|NCT02421510|141701427|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-21.6|STANDARD_ERROR_OF_MEAN|5.38|<|0.001|TWO_SIDED|95.0|-32.2|-11.0||Threshold for significance \<= 0.05|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline Fasting Plasma Glucose-by-time interaction as a covariate.||-11|-32.2|< 0.001
71034809|NCT03086460|141578870|SUPERIORITY||Hazard Ratio (HR)|2.24||||0.042|TWO_SIDED|95.0|1.03|4.86|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||4.86|1.03|0.042
71034810|NCT03086460|141578870|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.435|TWO_SIDED|95.0|0.6|3.23|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||3.23|0.60|0.435
70978900|NCT00868790|141465821|SUPERIORITY_OR_OTHER||LSM Difference|-49.4|||<|0.001|TWO_SIDED|90.0|-66.9|-31.8|||LDA Model|Between-group difference (metformin-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-31.8|-66.9|<0.001
70978901|NCT00868790|141465822|SUPERIORITY_OR_OTHER||LSM Difference|-0.8||||0.742|TWO_SIDED|90.0|-4.6|3.1|||LDA Model|||LDL-C values after log transformation were analyzed using a constrained LDA model that included terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). Percentage change from baseline in LDL-C after 4-week treatment was reported, after back-transformation using the delta method with an alpha-level of 0.10 (2-sided).||3.1|-4.6|0.742
70978902|NCT00868790|141465822|SUPERIORITY_OR_OTHER||LSM Difference|4.5||||0.06|TWO_SIDED|90.0|0.6|8.4|||LDA Model|||LDL-C values after log transformation were analyzed using a constrained LDA model that included terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). Percentage change from baseline in LDL-C after 4-week treatment was reported, after back-transformation using the delta method with an alpha-level of 0.10 (2-sided).||8.4|0.6|0.060
70978903|NCT00868790|141465822|SUPERIORITY_OR_OTHER||LSM Difference|7.8||||0.002|TWO_SIDED|90.0|3.8|11.7|||LDA Model|||LDL-C values after log transformation were analyzed using a constrained LDA model that included terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). Percentage change from baseline in LDL-C after 4-week treatment was reported, after back-transformation using the delta method with an alpha-level of 0.10 (2-sided).||11.7|3.8|0.002
70978904|NCT00868790|141465822|SUPERIORITY_OR_OTHER||LSM Difference|-3.9||||0.248|TWO_SIDED|90.0|-10.2|2.3|||LDA Model|||LDL-C values after log transformation were analyzed using a constrained LDA model that included terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). Percentage change from baseline in LDL-C after 4-week treatment was reported, after back-transformation using the delta method with an alpha-level of 0.10 (2-sided).||2.3|-10.2|0.248
70978905|NCT03068715|141465833|SUPERIORITY|We assessed the superiority of active over sham.|||||<|0.001|||||||Mixed Models Analysis|||MADRS scores were assessed with generalized linear mixed models (GLMM) that used Satterthwaite approximation of degrees of freedom and robust estimation of coefficients to handle violations of model assumptions. Fixed effects of time, treatment group (sham vs. active) and their interaction were assessed.||||<0.001
70978906|NCT03068715|141465834|SUPERIORITY|We assessed the superiority of active over sham.|||||=|0.001|||||||Mixed Models Analysis|||HDRS-17 scores were assessed with generalized linear mixed models (GLMM) that used Satterthwaite approximation of degrees of freedom and robust estimation of coefficients to handle violations of model assumptions. Fixed effects of time, treatment group (sham vs. active) and their interaction were assessed.||||=0.001
71034811|NCT03086460|141578870|SUPERIORITY||Hazard Ratio (HR)|1.27||||0.564|TWO_SIDED|95.0|0.56|2.89|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||2.89|0.56|0.564
71034812|NCT03086460|141578870|SUPERIORITY|"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."|Hazard Ratio (HR)|0.91||||0.818|TWO_SIDED|95.0|0.41|2.01|||Regression, Cox|||||2.01|0.41|0.818
71034813|NCT02718963|141578904|OTHER||Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test was used to compare the Videofluoroscopic swallowing study(VFSS) kinematic variables, VDS, PAS, and high resolution manometry (HRM) variables between the neuromuscular electrical stimulation session and the control session in swallowing thin fluid and thick fluid for healthy, dysphagic and whole participants. Mann-Whitney test was used to compare the differences of VFSS variables, VDS, PAS, and HRM variables between the healthy participants and dysphagic participants.||||< 0.05
71034814|NCT00836472|141578916|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.41||||||90.0|88.43|105.1|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.10|88.43|
71034815|NCT00836472|141578917|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.78||||||90.0|95.14|102.57|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.57|95.14|
71034816|NCT00836472|141578918|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.52||||||90.0|94.44|102.78|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.78|94.44|
71034817|NCT00836472|141578919|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|94.08||||||90.0|89.6|98.77|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||98.77|89.60|
70978907|NCT03068715|141465837|SUPERIORITY|We assessed the superiority of active over sham.|||||=|0.001|||||||Mixed Models Analysis|||HDRS-17 scores were assessed with generalized linear mixed models (GLMM) that used Satterthwaite approximation of degrees of freedom and robust estimation of coefficients to handle violations of model assumptions. Fixed effects of time, treatment group (sham vs. active) and their interaction were assessed.||||=0.001
71034818|NCT00836472|141578920|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.33||||||90.0|92.6|100.21|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100.21|92.60|
70922637|NCT04878354|141336355|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9124|TWO_SIDED|95.0|0.93|1.08|||Generalised linear mixed model (GLMM)||Odds ration is (odds placebo SLIT-tablet / odds tree SLIT-tablet)|The odds of having a severe day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model includes proportion of severe days as the response variable and treatment, cohort, and age group as fixed effects and pollen station as random effect. Observed p-value.||1.08|0.93|0.9124
70922638|NCT04878354|141336356|SUPERIORITY||Odds Ratio (OR)|0.76|||<|0.0001|TWO_SIDED|95.0|0.71|0.81|||Generalised linear fixed model (GLMM)||Odds ratio is (odds placebo SLIT-tablet / odds tree SLIT-tablet)|The odds of having a well day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model includes proportion of well days as the response variable and treatment, cohort, and age group as fixed effects and pollen station as random effect. Observed p-value.||0.81|0.71|<0.0001
70922639|NCT04878354|141336357|SUPERIORITY||Odds Ratio (OR)|0.89|||<|0.0001|TWO_SIDED|95.0|0.85|0.93|||Generalised linear mixed model (GLMM)||Odds ratio is (odds placebo SLIT-tablet / odds tree SLIT-tablet)|The odds of having a well day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model includes proportion of well days as the response variable and treatment, cohort, and age group as fixed effects and pollen station as random effect. Observed p-value.||0.93|0.85|<0.0001
70922640|NCT04878354|141336358|SUPERIORITY||Odds Ratio (OR)|0.78|||<|0.0001|TWO_SIDED|95.0|0.72|0.84|||Generalised linear mixed model (GLMM)||Odds ratio is (odds placebo SLIT-tablet / odds tree SLIT-tablet)|The odds of having a symptom-free day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model includes proportion of symptom-free days as the response variable and treatment, cohort, and age group as fixed effects and pollen station as random effect. Observed p-value.||0.84|0.72|<0.0001
70922641|NCT04878354|141336359|SUPERIORITY||Odds Ratio (OR)|0.9||||0.0001|TWO_SIDED|95.0|0.86|0.95|||Generalised linear mixed model (GLMM)||Odds ratio is (odds placebo SLIT-tablet / odds tree SLIT-tablet)|The odds of having a symptom-free day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model includes proportion of symptom-free days as the response variable and treatment, cohort, and age group as fixed effects and pollen station as random effect. Observed p-value.||0.95|0.86|0.0001
70922642|NCT04878354|141336362|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.0015|TWO_SIDED|95.0|0.07|0.29|||Mixed Models Analysis||Placebo SLIT-tablet vs tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in an LME model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.29|0.07|0.0015
70922643|NCT04878354|141336363|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.0032|TWO_SIDED|95.0|0.04|0.2|||Mixed Models Analysis||Placebo SLIT-tablet vs tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.20|0.04|0.0032
70922644|NCT04878354|141336364|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.9277|TWO_SIDED|95.0|-0.21|0.23|||Mixed Models Analysis||Placebo SLIT-tablet vs tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The endpoint was analysed in each dataset in a linear mixed effects (LME) model with treatment and cohort as fixed effects, and pollen station within cohort as a random effect. Each treatment group was allowed different residual errors. Observed p-value.||0.23|-0.21|0.9277
70922645|NCT04878354|141336365|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9643|TWO_SIDED|95.0|-0.19|0.18|||Mixed Models Analysis||Placebo SLIT-tablet vs tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The endpoint was analysed in each dataset in a linear mixed effect (LME) model with treatment and cohort as fixed effects, and pollen station within cohort as a random effect. Each treatment group was allowed different residual errors. Observed p-value.||0.18|-0.19|0.9643
70922646|NCT04878354|141336366|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.0287|TWO_SIDED|95.0|0.02|0.34|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The endpoint was analysed in each dataset in a linear mixed effect (LME) model with treatment and cohort as fixed effects, and pollen station within cohort as a random effect. Each treatment group was allowed different residual errors. Observed p-value.||0.34|0.02|0.0287
70922647|NCT04878354|141336368|SUPERIORITY||Odds Ratio (OR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.3|0.58|||Generalized linear mixed model (GLMM)||Odds ratio is (odds placebo SLIT-tablet/ odds tree SLIT-tablet)|"Multiple imputation was used to impute missing data under the hypothetical strategy.~The odds of having an improved treatment efficacy according to patient-rated global evaluation was analysed using a generalised linear mixed model with a logit link function. The model includes patient-rated global evaluation of treatment efficacy (improvement/no improvement) as the response variable and treatment, cohort and age group as fixed effects and pollen station as random effects. Observed p-value."||0.58|0.30|<0.0001
70922648|NCT04878354|141336369|SUPERIORITY||Mean Difference (Final Values)|0.43|||<|0.0001|TWO_SIDED|95.0|0.38|0.48|||Mixed Models Analysis||Tree SLIT-tablet vs placebo SLIT-tablet, visit 4|Change from baseline (screening) to visit 4 (pre-TPS). Change from baseline of log transformed concentrations is analyzed in a mixed effects linear model including treatment, visit, and treatment-visit-interaction as fixed effects, log(baseline concentration) as a covariate and subject as random effect. Observed p-value.||0.48|0.38|<0.0001
71034819|NCT00836472|141578921|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.01||||||90.0|92.18|100.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100.00|92.18|
71034820|NCT01695239|141578922|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71034821|NCT01695239|141578922|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71034822|NCT01695239|141578922|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71034823|NCT03552484|141578983|SUPERIORITY||Median Difference (Final Values)|0.05||||0.59|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Within-group paired t-tests and between-group paired t-tests||||0.59
70978908|NCT03068715|141465838|SUPERIORITY|"FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis.~sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas."|||||=|0.308|||||||t-test, 2 sided|Paired-t test was used for the statistics.||Functional connectivity between lsgACC\_lDMN in participants receiving active iTBS.||||=0.308
70978909|NCT03068715|141465838|SUPERIORITY|FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis. sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas.|||||=|0.778|||||||t-test, 2 sided|Paired t-test was used for the statistics.||Functional connectivity between lsgACC\_lDMN in participants receiving sham iTBS.||||=0.778
70978910|NCT03068715|141465838|SUPERIORITY|"FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis.~sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas."|||||=|0.468|||||||t-test, 2 sided|Paired t-test was used for the statistics.||Functional connectivity between lDMN\_rDMN in participants receiving active iTBS.||||=0.468
70978911|NCT03068715|141465838|SUPERIORITY|FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis. sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas.|||||=|0.486|||||||t-test, 2 sided|Paired t-test was used for the statistics.||Functional connectivity between lDMN\_rDMN in participants receiving sham iTBS.||||=0.486
70978912|NCT03068715|141465839|SUPERIORITY|"FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis.~sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas."|||||=|0.447|||||||t-test, 2 sided|Paired t-test was used for the statistics.||Functional connectivity between lsgACC\_lDMN in participants receiving active iTBS.||||=0.447
70978913|NCT03068715|141465839|SUPERIORITY|"FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis.~sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas."|||||=|0.115|||||||t-test, 2 sided|Paired t-test was used for the statistics.||Functional connectivity between lsgACC\_lDMN in participants receiving sham iTBS.||||=0.115
70978914|NCT03068715|141465839|SUPERIORITY|"FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis.~sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas."|||||=|0.546|||||||t-test, 2 sided|Paired t-test was used for the statistics.||Functional connectivity between lDMN\_rDMN in participants receiving active iTBS.||||=0.546
71096287|NCT02421510|141701427|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-25.7|STANDARD_ERROR_OF_MEAN|5.37|<|0.001|TWO_SIDED|95.0|-36.2|-15.1||Threshold for significance \<= 0.05|MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline Fasting Plasma Glucose-by-time interaction as a covariate.||-15.1|-36.2|< 0.001
70978915|NCT03068715|141465839|SUPERIORITY|"FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis.~sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas."|||||=|0.607|||||||t-test, 2 sided|||Functional connectivity between lDMN\_rDMN in participants receiving sham iTBS.||||=0.607
70978916|NCT03068715|141465840|SUPERIORITY||P value of the interaction|0.11|||<|0.05|TWO_SIDED|||||Not adjusted for multiple comparisons at this time.|Mixed Models Analysis|We were interested in the interaction between treatment condition and timepoint.||We conducted a linear mixed models analysis, with a focus on the interaction term. No power analysis for this measure because number of participants was determined by other primary study aims.||||<0.05
70978917|NCT03068715|141465841|SUPERIORITY|The SDNN (the standard deviation of the RR intervals) was recorded using ECG. It was not necessary to conduct a power analysis for this measure because the number of participants in the study was based on other considerations (primary treatment goals of the study).|P value of the interaction|0.245|||<|0.05|TWO_SIDED|||||For reporting purposes here the p value was not adjusted for multiple comparisons.|Mixed Models Analysis|We were interested in the significance of the interaction between treatment group and timepoint.||We used a linear mixed models analysis, with the fixed factors being treatment group and timepoint.||||<0.05
71008759|NCT02055976|141525250|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-15.035|STANDARD_ERROR_OF_MEAN|9.389||0.056|TWO_SIDED|95.0|-33.698|3.629|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||3.629|-33.698|0.056
71008760|NCT02055976|141525252|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-76.189|STANDARD_ERROR_OF_MEAN|5.431|<|0.001|TWO_SIDED|95.0|-86.975|-65.403|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-65.403|-86.975|<0.001
70978918|NCT01276288|141465861|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|107.08|STANDARD_DEVIATION|11.8||0.0092|TWO_SIDED|90.0|97.11|118.07||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa plus HCT divided by Empa"|ANOVA|Model was adjusted for sequence, period and treatment as fixed effects while subjects within sequences as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+HCT were included||118.07|97.11|0.0092
70978919|NCT01276288|141465861|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|107.83|STANDARD_DEVIATION|8.9||0.003|TWO_SIDED|90.0|100.14|116.11||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa plus TOR divided by Empa"|ANOVA|Model was adjusted for sequence, period and treatment as fixed effects while subjects within sequences as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||116.11|100.14|0.0030
70978920|NCT01276288|141465862|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|102.78|STANDARD_DEVIATION|18.3||0.0199|TWO_SIDED|90.0|88.55|119.29||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ HCT divided by Empa"|ANOVA|Model was adjusted for sequence, period and treatment as fixed effects while subjects within sequences as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+HCT were included||119.29|88.55|0.0199
70978921|NCT01276288|141465862|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|107.5|STANDARD_DEVIATION|11.3||0.0086|TWO_SIDED|90.0|97.9|118.04||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR divided by Empa"|ANOVA|Model was adjusted for sequence, period and treatment as fixed effects while subjects within sequences as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||118.04|97.90|0.0086
70978922|NCT01276288|141465863|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|96.27|STANDARD_DEVIATION|9.6||0.0008|TWO_SIDED|90.0|89.08|104.05||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa plus HCT divided by HCT"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+HCT were included||104.05|89.08|0.0008
70978923|NCT01276288|141465864|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|101.77|STANDARD_DEVIATION|17.1||0.0114|TWO_SIDED|90.0|88.63|116.85||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ HCT divided by HCT"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+HCT were included||116.85|88.63|0.0114
70978924|NCT01276288|141465865|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|101.44|STANDARD_DEVIATION|2.9|<|0.0001|TWO_SIDED|90.0|99.06|103.88||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa plus TOR divided by TOR"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||103.88|99.06|<0.0001
71034824|NCT03552484|141578984|SUPERIORITY||Mean Difference (Final Values)|-1.43||||0.59|TWO_SIDED|95.0||||Between-group comparison|t-test, 2 sided|||||||0.59
71034825|NCT03552484|141578985|SUPERIORITY||Mean Difference (Final Values)|0.44||||0.62|TWO_SIDED|||||Between-group comparison of change in Multidimensional Caregiver Strain Index|t-test, 2 sided|||||||0.62
71034826|NCT03264092|141578990|OTHER|This was just a comparative study. No superiority, equivalence or non inferiority analysis was performed.||||||0.18|||||||Fisher Exact|||||||0.18
71034827|NCT03264092|141578991|OTHER|This was just a comparative study. No superiority, equivalence or non inferiority analysis was performed.||||||0.41|||||||Fisher Exact|||||||0.41
70978925|NCT01276288|141465865|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|104.42|STANDARD_DEVIATION|4.8|<|0.0001|TWO_SIDED|90.0|100.39|108.62||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR-M1 divided by TOR-M1"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||108.62|100.39|<0.0001
71034828|NCT03264092|141578992|OTHER|This was just a comparative study. No superiority, equivalence or non inferiority analysis was performed.||||||0.45|||||||Fisher Exact|||||||0.45
71034829|NCT02663349|141579004|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|df = 14||Within sample analysis of change between baseline and 3 month assessment.||||.08
71034830|NCT02663349|141579005|SUPERIORITY|||||||0.69|||||||t-test, 2 sided|||Within sample change between baseline and 6 month assessment.||||.69
71034831|NCT02663349|141579006|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|df=14||Within sample change assessed between baseline and 3-month assessment||||.02
71034832|NCT02663349|141579007|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|df = 14||Change between baseline and 6 month assessment||||.34
71034833|NCT02663349|141579008|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||completer analysis of change between baseline and 3-month assessment on the AIHQ Hostility scale||||>.05
71034834|NCT02663349|141579008|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Completer analysis to examine within group change between baseline and 3-month assessment on the AIHQ Aggression scale||||.04
71034835|NCT02663349|141579009|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||completer analysis of within group change on the AIHQ Hostility scale between baseline and the 6-month assessment||||>.05
71034836|NCT02663349|141579009|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||completer analysis of within group change on the AIHQ Aggression scale between baseline and the 6 month assessment||||> .05
71034837|NCT02663349|141579010|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 15||Change within group between baseline and 3 month assessment on the TASIT total score for part 3||||> .05
71034838|NCT02663349|141579011|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 15||within group change on the TASIT total score for Part 3 between baseline and the 6 month assessment||||> .05
71034839|NCT02663349|141579012|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 14||Within group change on SSPA Total Score between baseline and 3-month assessment||||>.05
70978926|NCT01276288|141465865|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|103.19|STANDARD_DEVIATION|8.9||0.0005|TWO_SIDED|90.0|95.93|111.01||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR-M3 divided by TOR-M3"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||111.01|95.93|0.0005
70978927|NCT01276288|141465866|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|104.43|STANDARD_DEVIATION|13.1||0.0066|TWO_SIDED|90.0|93.81|116.25||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR divided by TOR"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||116.25|93.81|0.0066
70978928|NCT01276288|141465866|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|102.67|STANDARD_DEVIATION|10.6||0.0012|TWO_SIDED|90.0|94.13|111.97||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR-M1 divided by TOR-M1"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||111.97|94.13|0.0012
70978929|NCT01276288|141465866|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|102.42|STANDARD_DEVIATION|5.8|<|0.0001|TWO_SIDED|90.0|97.65|107.42||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR-M3 divided by TOR-M3"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||107.42|97.65|<0.0001
70978930|NCT03168867|141465875|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<.05
70978931|NCT05003115|141465905|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|-6.36||||0.101|TWO_SIDED|95.0|-14.17|1.44|||Regression, Linear|||||1.44|-14.17|0.101
70978932|NCT05003115|141465906|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|-0.1||||0.78|TWO_SIDED|95.0|-0.79|0.59|||Regression, Linear|||||0.59|-0.79|0.78
70978933|NCT05003115|141465907|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|-0.95||||0.314|TWO_SIDED|95.0|-2.83|0.94|||Regression, Linear|||||0.94|-2.83|0.314
70978934|NCT05003115|141465908|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|-1.04||||0.679|TWO_SIDED|95.0|-6.0|3.92|||Regression, Linear|||||3.92|-6.00|0.679
70978935|NCT05003115|141465909|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|0.01||||0.994|TWO_SIDED|95.0|-2.23|2.25|||Regression, Linear|||||2.25|-2.23|0.994
70978936|NCT05003115|141465910|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|-1.22||||0.258|TWO_SIDED|95.0|-3.33|0.89|||Regression, Linear|||||0.89|-3.33|0.258
70978937|NCT05003115|141465911|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|-0.4||||0.857|TWO_SIDED|95.0|-4.75|3.96|||Regression, Linear|||||3.96|-4.75|0.857
70978938|NCT04696861|141465931|SUPERIORITY|||||||0.961||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||Generalized linear mixed models were conducted and odds ratios (ORs) were reported||||0.961
70978939|NCT04696861|141465932|SUPERIORITY|||||||0.961||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||Generalized linear mixed models were conducted and odds ratios (ORs) were reported||||0.961
70978940|NCT04696861|141465933|SUPERIORITY|||||||0.368||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||Generalized linear mixed models were conducted and odds ratios (ORs) were reported||||0.368
70978941|NCT04696861|141465935|SUPERIORITY|||||||0.634||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.634
70978942|NCT04696861|141465936|SUPERIORITY|||||||0.832||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.832
70978943|NCT04696861|141465938|SUPERIORITY|||||||0.624||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||Generalized linear mixed models were conducted and odds ratios (ORs) were reported||||0.624
70978944|NCT04696861|141465939|SUPERIORITY|||||||0.833||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.833
70978945|NCT04696861|141465940|SUPERIORITY|||||||0.7||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.7
70978946|NCT04696861|141465941|SUPERIORITY|||||||0.79||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.79
71096288|NCT02421510|141701428|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|2.0|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|1.3|2.7||Threshold for significance \<= 0.05.|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline DTSQs total score-by-time interaction as a covariate.||2.7|1.3|< 0.001
71096289|NCT02421510|141701428|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|1.7|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|1.0|2.4||Threshold for significance \<= 0.05.|MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline DTSQs total score-by-time interaction as a covariate.||2.4|1|< 0.001
70978947|NCT04696861|141465942|SUPERIORITY|||||||0.55||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.55
70978948|NCT04696861|141465943|SUPERIORITY|||||||0.823|||||||Mixed Models Analysis|||||||.823
70978949|NCT04696861|141465944|SUPERIORITY|||||||0.942|||||||Mixed Models Analysis|||||||.942
70978950|NCT04696861|141465945|SUPERIORITY|||||||0.207||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.207
70978951|NCT04696861|141465946|SUPERIORITY|||||||0.594||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.594
70978952|NCT04696861|141465947|SUPERIORITY|||||||0.738||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.738
70978953|NCT04696861|141465948|SUPERIORITY|||||||0.845||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.845
70978954|NCT02382133|141465952|SUPERIORITY|comparing nasal and forehead oximetry sensor pressure ulcer incidence|||||=|0.006|||||||Chi-squared|||||||=.006
70978955|NCT00655928|141465953|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
70978956|NCT01707992|141465983|SUPERIORITY||Hazard Ratio (HR)|0.937|||=|0.7057|TWO_SIDED|95.0|0.668|1.313||Threshold for significance at 0.05 level.|Cox proportional hazards model|||The primary analysis for the comparison between laquinimod 0.6 mg versus placebo was conducted using the baseline adjusted Cox proportional hazards model. Categorical EDSS at baseline (less than or equal to \[\<=\] 4 or greater than \[\>\] 4), country/geographical region (CGR), categorical age at baseline (\<=38 or \>38), and T2 volume at baseline were included as covariates in the model.||1.313|0.668|= 0.7057
70978957|NCT01976806|141465998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.13|<|0.05|||||||Mixed Models Analysis|Compound-symmetry covariance structure with age, sex, BMI, race, baseline pocket depth, baseline RBC DHA level, and intervention group variables|Mean change in pocket depth (3-month follow-up minus baseline) among dental sites with baseline pocket depths \>=5 mm in the DHA intervention group versus the placebo group.|Intent-to-treat basis with a type I error rate of 0.05. The follow-up pocket depth, was assessed in linear mixed effects models with a compound-symmetry covariance structure and age, sex, BMI, race, baseline pocket depth, baseline red blood cell (RBC) DHA level (dichotomized at median), and intervention group as fixed-effect variables.||||<0.05
70978958|NCT04551014|141466020|NON_INFERIORITY|For polypectomy without submucosal injection of EverLiftTM to be considered non-inferior, we calculated that 115 polyps were needed in each group to achieve an alpha value of 0.05, power of 90%, and non-inferiority margin of -10%.||||||0.424|||||||t-test, 2 sided|||||||0.424
70978959|NCT04551014|141466021|SUPERIORITY||||||<|0.0001||||||P-value of \<0.05 was considered statistically significant.|t-test, 2 sided|||||||<0.0001
70978960|NCT04551014|141466022|SUPERIORITY|||||||0.697||||||P-value of \<0.05 was considered statistically significant.|Chi-squared|||||||0.697
70978961|NCT00891202|141466041|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-30.03|STANDARD_ERROR_OF_MEAN|3.35|<|0.0001|TWO_SIDED|95.0|-36.82|-23.24|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model fitted with treatment and baseline spleen severity (low spleen severity: spleen volume less than or equal to \[\<=\] 20 multiples of normal spleen volume, high spleen severity: spleen volume greater than \[\>\] 20 multiples of normal spleen volume).||-23.24|-36.82|<0.0001
70978962|NCT04108429|141466058|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||generalized linear mixed model - this analysis accounts for repeated measures from each participant over the course of Weeks 1, 2, 4, 6 and 8||||.830
70978963|NCT04108429|141466059|SUPERIORITY|||||||0.759|||||||Mixed Models Analysis|||generalized linear mixed model - this analysis accounts for repeated measures from each participant over the course of Weeks 1, 2, 4, 6 and 8||||.759
70978964|NCT04108429|141466060|SUPERIORITY|||||||0.275|||||||Simulation Modeling Analysis (SMA) for T|||Counseling center utilization data were examined using Simulation Modeling Analysis (SMA) for Time-Series data to determine if there were changes in utilization between the pre-implementation and implementation phases. SMA evaluates the statistical significance of between-phase changes in data streams and also accounts for the presence of autocorrelation (the non-independence of data points in time-series data streams).||||.275
70978965|NCT04108429|141466062|SUPERIORITY|generalized linear mixed model||||||0.002|||||||Mixed Models Analysis|||||||.002
70978966|NCT04108429|141466063|SUPERIORITY|||||||0.489|||||||Mixed Models Analysis|||generalized linear mixed model||||.489
70978967|NCT04108429|141466064|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||generalized linear mixed model||||.001
70978968|NCT01587950|141466065|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.99||||0.8918|TWO_SIDED|95.0|-15.5|13.52|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||13.52|-15.50|0.8918
70978969|NCT01587950|141466065|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.89||||0.5183|TWO_SIDED|95.0|-19.91|10.14|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||10.14|-19.91|0.5183
70978970|NCT01587950|141466065|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.89||||0.5718|TWO_SIDED|95.0|-17.59|9.8|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||9.80|-17.59|0.5718
71034840|NCT02663349|141579013|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 14||Within group change on the SSPA total score between baseline and 6 month assessment||||> .05
71034841|NCT02663349|141579014|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 15||Within group change on the First Episode Social Functioning Scale Performance Total score on scales 1-7 between baseline and 3-month follow-up||||> .05
71096290|NCT02421510|141701429|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.025|TWO_SIDED|95.0|-0.6|0.0||Threshold for significance \<= 0.05.|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline DDS2 total score-by-time interaction as a covariate.||0|-0.6|0.025
70978971|NCT01587950|141466065|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.37||||0.6591|TWO_SIDED|95.0|-11.82|18.56|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||18.56|-11.82|0.6591
70978972|NCT01587950|141466065|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.02||||0.6921|TWO_SIDED|95.0|-18.17|12.13|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||12.13|-18.17|0.6921
70978973|NCT01587950|141466065|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.39||||0.3513|TWO_SIDED|95.0|-19.98|7.2|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||7.20|-19.98|0.3513
71034842|NCT02663349|141579015|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 15||Within group change between baseline and 6-month assessment on the First Episode Social Functioning Scale Performance total score on scales 1-7||||> .05
71034843|NCT02663349|141579016|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Collegial Support scale between Baseline and 3-Month assessments||||.15
71034844|NCT02663349|141579016|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Task Support scale between baseline and 3-month assessments||||.10
71034845|NCT02663349|141579016|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Mentor scale between baseline and the 3-month assessment||||>.05
71034846|NCT02663349|141579016|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Coach scale between baseline and the 3 month assessment||||> .05
71034847|NCT02663349|141579017|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Collegial Support scale between baseline and the 6-month assessment||||.01
70978974|NCT01587950|141466065|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.96||||0.2346|TWO_SIDED|95.0|-5.96|23.88|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||23.88|-5.96|0.2346
70978975|NCT01587950|141466065|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.24||||0.4138|TWO_SIDED|95.0|-8.92|21.39|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||21.39|-8.92|0.4138
70978976|NCT01587950|141466065|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.72||||0.6931|TWO_SIDED|95.0|-16.44|10.99|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||10.99|-16.44|0.6931
70978977|NCT01587950|141466066|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.39||||0.3867|TWO_SIDED|95.0|-21.04|8.26|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||8.26|-21.04|0.3867
70978978|NCT01587950|141466066|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-11.22||||0.1448|TWO_SIDED|95.0|-26.41|3.96|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||3.96|-26.41|0.1448
70978979|NCT01587950|141466066|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.83||||0.4874|TWO_SIDED|95.0|-18.66|8.99|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||8.99|-18.66|0.4874
70978980|NCT01587950|141466066|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-9.87||||0.2038|TWO_SIDED|95.0|-25.23|5.49|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||5.49|-25.23|0.2038
70978981|NCT01587950|141466066|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-11.12||||0.1518|TWO_SIDED|95.0|-26.43|4.19|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||4.19|-26.43|0.1518
70978982|NCT01587950|141466066|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.25||||0.8567|TWO_SIDED|95.0|-14.98|12.49|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||12.49|-14.98|0.8567
70978983|NCT01587950|141466066|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.01||||0.1493|TWO_SIDED|95.0|-4.06|26.08|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, at 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||26.08|-4.06|0.1493
70978984|NCT01587950|141466066|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.45||||0.4798|TWO_SIDED|95.0|-9.86|20.76|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||20.76|-9.86|0.4798
71034848|NCT02663349|141579017|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Task Support scale between baseline and 6-month assessment||||.03
71034849|NCT02663349|141579017|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Mentor scale between baseline and the 6-month assessment||||> .05
70978985|NCT01587950|141466066|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.56||||0.4255|TWO_SIDED|95.0|-19.42|8.29|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||8.29|-19.42|0.4255
70978986|NCT01587950|141466067|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.96||||0.7769||95.0|-15.71|11.8||ANCOVA with factors for treatment group, application site, period and random effect for subject.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||11.80|-15.71|0.7769
70978987|NCT01587950|141466067|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.32||||0.3811|TWO_SIDED|95.0|-20.64|8.0|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||8.00|-20.64|0.3811
70978988|NCT01587950|141466067|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.36||||0.5044||95.0|-17.35|8.63|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||8.63|-17.35|0.5044
70978989|NCT01587950|141466067|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.68||||0.4374|TWO_SIDED|95.0|-20.2|8.84|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||8.84|-20.20|0.4374
70978990|NCT01587950|141466067|SUPERIORITY_OR_OTHER||Slope|-4.02||||0.5796|TWO_SIDED|95.0|-18.46|10.41|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||10.41|-18.46|0.5796
70978991|NCT01587950|141466067|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.66||||0.7994|TWO_SIDED|95.0|-11.32|14.64|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05||14.64|-11.32|0.7994
70978992|NCT01587950|141466067|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.75||||0.2784|TWO_SIDED|95.0|-6.42|21.93|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||21.93|-6.42|0.2784
70978993|NCT01587950|141466067|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.68||||0.3581|TWO_SIDED|95.0|-7.75|21.12|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||21.12|-7.75|0.3581
71034850|NCT02663349|141579017|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Coach scale between baseline and the 6-month assessment||||> .05
71034851|NCT02663349|141579018|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|df = 13||Within group change on the VETSS Self Disclosure scale between Baseline and 3-Month Assessment||||.09
71034852|NCT02663349|141579018|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|df = 13||Within group change on the VETSS Workplace Coping scale between Baseline and 3-Month Assessment||||.12
71034853|NCT02663349|141579019|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 13||Within group change on VETSS Self Disclosure scale between Baseline and 6 month assessment||||> .05
71034854|NCT02663349|141579019|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 13||Within group change on VETSS Workplace Coping scale between baseline and the 6 month assessment||||> .05
71034855|NCT00673660|141579044|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Values less than 0.05 were considered statistically significant.|t-test, 2 sided|||Total cholesterol||||<0.001
71034856|NCT00673660|141579044|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Values less than 0.05 were considered statistically significant.|t-test, 2 sided|||LDL cholesterol||||<0.001
71034857|NCT00673660|141579044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.972|TWO_SIDED|||||p-Values less than 0.05 were considered statistically significant.|t-test, 1 sided|||HDL cholesterol||||0.972
71034858|NCT00673660|141579044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034|TWO_SIDED|||||p-Values less than 0.05 were considered statistically significant.|t-test, 2 sided|||Triglycerides||||0.034
71034859|NCT02825680|141579058|SUPERIORITY|||||||0.011|||||||Mixed Models Analysis|||This analysis compares reach within the pre-intervention timeframe versus the post-intervention timeframe for each LEAP (intervention) and control case. Intention to treat analysis was used; all participating facilities randomized to the LEAP (intervention) arm were included whether or not they completed the intervention.||||.011
70978994|NCT01587950|141466067|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.07||||0.8703|TWO_SIDED|95.0|-14.11|11.97|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||11.97|-14.11|0.8703
70978995|NCT02848833|141466104|OTHER||||||<|0.0001||||||Difference before administration versus after administration was analyzed using a paired t-test.|paired t-test|||||||<0.0001
70978996|NCT02848833|141466107|OTHER||||||<|0.0001||||||Difference before administration versus after administration was analyzed using a paired t-test.|paired t-test|||||||<0.0001
70978997|NCT02848833|141466108|OTHER|Difference before administration versus after administration was analyzed using a paired t-test.|||||<|0.0001|||||||paired t-test|||||||<0.0001
70978998|NCT02848833|141466109|OTHER||||||<|0.0001||||||Difference before administration versus after administration was analyzed using a paired t-test.|paired t-test|||||||<0.0001
70978999|NCT02848833|141466110|OTHER||||||<|0.0001||||||Difference before administration versus after administration was analyzed using a paired t-test.|paired t-test|||||||<0.0001
70979000|NCT02847598|141466112|SUPERIORITY||Least squares (LS) mean Difference|-3.4||||0.037|TWO_SIDED|95.0|-6.7|-0.2|||MMRM|||A Mixed Effect Model Repeat Measurement (MMRM) model is performed, using treatment group, study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region, study visit-by-treatment interaction, baseline value of the outcome measure, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.||-0.2|-6.7|0.037
70979001|NCT02847598|141466113|SUPERIORITY||LS mean difference|-24.29||||0.015|TWO_SIDED|95.0|-43.7|-4.88|||MMRM|||A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.||-4.88|-43.70|0.015
70979002|NCT02847598|141466113|SUPERIORITY||LS mean difference|-33.42|||<|0.001|TWO_SIDED|95.0|-52.71|-14.12|||MMRM|||A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.||-14.12|-52.71|<0.001
70979003|NCT02847598|141466113|SUPERIORITY||LS mean difference|-27.99||||0.001|TWO_SIDED|95.0|-44.55|-11.42|||MMRM|||A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.||-11.42|-44.55|0.001
70979004|NCT02847598|141466116|SUPERIORITY||LS Mean Difference|-9.93||||0.22|TWO_SIDED|95.0|-25.94|6.08|||MMRM|||Week 12: A MMRM model is performed, using treatment group study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region, study visit-by-treatment interaction, baseline value of the outcome measure, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.||6.08|-25.94|0.220
70979005|NCT02847598|141466116|SUPERIORITY||LS Mean Difference|-8.96||||0.293|TWO_SIDED|95.0|-25.82|7.9|||MMRM|||Week 16: A MMRM model is performed, using treatment group (BIIB059 450 mg vs. placebo), study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region study visit-by-treatment interaction, baseline value of the endpoint, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.||7.90|-25.82|0.293
70979006|NCT02847598|141466116|SUPERIORITY||LS Mean Difference|-15.74||||0.062|TWO_SIDED|95.0|-32.28|0.79|||MMRM|||Week 24: A MMRM model is performed, using treatment group, study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region study visit-by-treatment interaction, baseline value of the outcome measure, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.||0.79|-32.28|0.062
70979007|NCT02847598|141466117|SUPERIORITY||LS mean difference|-30.36||||0.001|TWO_SIDED|95.0|-48.75|-11.97|||MMRM|||A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.||-11.97|-48.75|0.001
70979008|NCT02847598|141466117|SUPERIORITY||LS mean difference|-37.17|||<|0.001|TWO_SIDED|95.0|-55.46|-18.87|||MMRM|||A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.||-18.87|-55.46|<0.001
70979009|NCT02847598|141466117|SUPERIORITY||LS mean difference|-26.05||||0.001|TWO_SIDED|95.0|-41.71|-10.4|||MMRM|||A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.||-10.40|-41.71|0.001
70979010|NCT02847598|141466123|SUPERIORITY||LS Mean Difference|-1.7||||0.007|TWO_SIDED|95.0|-3.0|-0.5|||MMRM|||A MMRM model is performed, using treatment group, study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region, study visit-by-treatment interaction, baseline value of the outcome measure, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.||-0.5|-3.0|0.007
70979011|NCT02847598|141466125|SUPERIORITY||LS mean difference|-0.16||||0.667|TWO_SIDED|95.0|-0.9|0.58|||MMRM|||A MMRM model is performed, using treatment group (BIIB059 450 mg vs. placebo), study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region, study visit-by-treatment interaction, baseline value of the endpoint, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.||0.58|-0.90|0.667
70979012|NCT04167345|141466148|SUPERIORITY||Mean Difference|1.7|||<|0.0001|TWO_SIDED|95.0|1.1|2.3|||t-test, 2 sided|||||2.3|1.1|<.0001
70979013|NCT04167345|141466148|SUPERIORITY||Mean Difference|2.0|||<|0.0001|TWO_SIDED|95.0|1.1|2.9|||t-test, 2 sided|||||2.9|1.1|<.0001
70979014|NCT04167345|141466150|SUPERIORITY||Mean Difference|2.0||||0.0114|TWO_SIDED|95.0|0.5|3.4|||t-test, 2 sided|||||3.4|0.5|0.0114
70979015|NCT04167345|141466150|SUPERIORITY||Mean Difference|2.3||||0.0009|TWO_SIDED|95.0|1.1|3.5|||t-test, 2 sided|||||3.5|1.1|0.0009
70979016|NCT01575912|141466152|OTHER|||||||0.121||||||using Mann Whitney test|Wilcoxon (Mann-Whitney)|||||||0.121
70979017|NCT01542307|141466153|SUPERIORITY_OR_OTHER|||||||0.674|||||||Wilcoxon (Mann-Whitney)|||||||0.674
70979018|NCT01542307|141466154|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
70979019|NCT01542307|141466155|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
70979020|NCT01542307|141466156|SUPERIORITY_OR_OTHER|||||||0.05|||||||Fisher Exact|||||||0.05
70979021|NCT01542307|141466157|SUPERIORITY_OR_OTHER|||||||0.05|||||||Fisher Exact|||||||0.05
70979022|NCT01542307|141466158|SUPERIORITY_OR_OTHER|||||||0.004|||||||Fisher Exact|||||||0.004
70979023|NCT01542307|141466159|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
70979024|NCT01542307|141466160|SUPERIORITY_OR_OTHER|||||||0.16|||||||Fisher Exact|||||||0.16
71034860|NCT01929863|141579078|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.13|||||TWO_SIDED|95.0|-50.4|-5.86|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Fasting Value.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for Fasting Value.||-5.86|-50.40|
71034861|NCT01929863|141579078|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.16|||||TWO_SIDED|95.0|-51.68|-6.64|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Maximum (0-4 h) Value.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for Maximum (0-4 h) Value.||-6.64|-51.68|
71034862|NCT01929863|141579078|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-36.58|||||TWO_SIDED|95.0|-62.25|-10.9|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Maximum (4-10 h) Value.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for Maximum (4-10 h) Value.||-10.90|-62.25|
71034863|NCT01929863|141579078|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-45.41|||||TWO_SIDED|95.0|-72.8|-18.03|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Maximum (10-14 h) Value.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for Maximum (10-14 h) Value.||-18.03|-72.80|
70979025|NCT00961532|141466172|SUPERIORITY_OR_OTHER|||||||0.014|||||||t-test, 2 sided|||We tested the hypothesis that there would be a change from baseline to 60 minutes after the start of the desmopressin (DDAVP) infusion.||||0.014
70979026|NCT02216695|141466226|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35|||||TWO_SIDED|95.0|1.3|1.4|||Regression, Logistic||This is OR for 65 to 74 years age group with \< 65 years as the reference group|||1.40|1.30|
70979027|NCT02216695|141466226|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72|||||TWO_SIDED|95.0|1.66|1.79|||Regression, Logistic||This is OR for age group 75 to 84 years age group with \< 65 years as reference|||1.79|1.66|
71034864|NCT01929863|141579078|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.35|||||TWO_SIDED|95.0|-50.84|-7.86|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Maximum (0-24 h) Value.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for Maximum (0-24 h) Value.||-7.86|-50.84|
71034865|NCT01929863|141579078|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.14|||||TWO_SIDED|95.0|-45.8|-6.49|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for AUC (0-4 h) Weighted Mean.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for AUC (0-4 h) Weighted Mean||-6.49|-45.80|
71034866|NCT01929863|141579078|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-32.0|||||TWO_SIDED|95.0|-55.41|-8.58|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for AUC (4-10 h) Weighted Mean.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for AUC (4-10 h) Weighted Mean.||-8.58|-55.41|
70979028|NCT02216695|141466226|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.03|||||TWO_SIDED|95.0|1.89|2.19|||Regression, Logistic||This is OR for age group equal to greater than 85 years age group with \< 65 years as reference|||2.19|1.89|
70979029|NCT02216695|141466227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|1.1|1.3|||Regression, Logistic||This is the OR for 1998-2003 discharge period with 2003-08 as the reference group|||1.30|1.10|
70979030|NCT02216695|141466227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|1.07|1.18|||Regression, Logistic||This is the OR for 2008-13 discharge period with 2003-08 as the reference group|||1.18|1.07|
70979031|NCT02811744|141466242|EQUIVALENCE|Equivalence was defined as no significant difference between study groups on a T-test.||||||0.5||||||No adjustments on the comparison. There was no multiple comparison adjustment for the p value, as this was the primary outcome. This is the experimental p value; the threshold for significance was 0.05.|t-test, 2 sided|||No power calculation. This is an exploratory study.||||0.5
70979032|NCT03878147|141466302|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Mean Difference (Final Values)|2.39|STANDARD_ERROR_OF_MEAN|0.82|<|0.01|TWO_SIDED|95.0|0.78|4.01||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||4.01|0.78|<.01
71034867|NCT01929863|141579078|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-40.96|||||TWO_SIDED|95.0|-66.64|-15.29|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for AUC (10-14 h) Weighted Mean.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for AUC (10-14 h) Weighted Mean.||-15.29|-66.64|
70979033|NCT03878147|141466302|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 6.|Mean Difference (Final Values)|0.82|STANDARD_ERROR_OF_MEAN|0.82||0.32|TWO_SIDED|95.0|-0.8|2.44||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||2.44|-0.80|.32
70979034|NCT03878147|141466302|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Mean Difference (Final Values)|-1.79|STANDARD_ERROR_OF_MEAN|0.99||0.07|TWO_SIDED|95.0|-3.74|0.16||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.16|-3.74|.07
70979035|NCT03878147|141466302|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 6.|Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.96||0.83|TWO_SIDED|95.0|-2.1|1.68||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||1.68|-2.10|.83
70979036|NCT03878147|141466303|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.28||0.65|TWO_SIDED|95.0|-0.71|0.42||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.42|-0.71|.65
70979037|NCT03878147|141466303|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 6.|Median Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.29||0.95|TWO_SIDED|95.0|-0.54|0.58||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.58|-0.54|.95
70979038|NCT03878147|141466303|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Median Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.27||0.34|TWO_SIDED|95.0|-0.92|0.13||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.13|-0.92|.34
70979039|NCT03878147|141466303|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 6.|Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.33||0.81|TWO_SIDED|95.0|-0.73|0.58||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.58|-0.73|.81
71034868|NCT01929863|141579078|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.76|||||TWO_SIDED|95.0|-54.67|-14.85|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for AUC (0-24 h) Weighted Mean.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for AUC (0-24 h) Weighted Mean.||-14.85|-54.67|
71034869|NCT01929863|141579079|SUPERIORITY_OR_OTHER||Ratio|1.013|||||TWO_SIDED|90.0|0.912|1.125|||||The point estimate was calculated as geometric least square mean ratio of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for AUC (0-10 h).|||1.125|0.912|
71034870|NCT01929863|141579080|SUPERIORITY_OR_OTHER||Ratio|1.036|||||TWO_SIDED|90.0|0.937|1.145|||||The point estimate was calculated as geometric least square mean ratio of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Cmax.|||1.145|0.937|
70979040|NCT03878147|141466304|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Median Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.01|TWO_SIDED|95.0|0.004|0.043||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.043|0.004|.01
71034871|NCT00830024|141579099|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on each of the pharmacokinetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|98.75||||||90.0|93.35|104.47|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.47|93.35|
71034872|NCT00830024|141579100|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on each of the pharmacokinetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|95.94||||||90.0|91.76|100.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||100.3|91.76|
71034873|NCT00830024|141579101|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on each of the pharmacokinetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|95.89||||||90.0|91.67|100.31|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||100.31|91.67|
71034874|NCT02709018|141579114|SUPERIORITY|||||||0.66|||||||Mixed Models Analysis|||||||0.66
71034875|NCT02709018|141579115|SUPERIORITY|||||||0.57|||||||Mixed Models Analysis|||||||0.57
71034876|NCT03100344|141579142|OTHER|mixed-effect model for repeated measures (MMRM)|mean difference of percentage changes|-13.6||||0.051|TWO_SIDED|95.0|-27.3|0.0|||Kenward-Rogers|||||0.0|-27.3|0.051
71034877|NCT03100344|141579142|OTHER|mixed-effect model for repeated measures (MMRM)|mean difference of percentage changes|-16.7||||0.016|TWO_SIDED|95.0|-30.2|-3.2|||Kenward Roger|||||-3.2|-30.2|0.016
71034878|NCT03100344|141579142|OTHER|mixed-effect model for repeated measures (MMRM)|mean difference of percentage changes|-6.8||||0.322|TWO_SIDED|95.0|-20.5|6.8|||Kenward Roger|||||6.8|-20.5|0.322
71034879|NCT03100344|141579143|SUPERIORITY||Mean Difference (Final Values)|18.9||||0.034|TWO_SIDED|95.0|2.0|35.8|||Cochran-Mantel-Haenszel|||||35.8|2.0|0.034
71034880|NCT03100344|141579143|SUPERIORITY||Mean Difference (Final Values)|31.4|||<|0.001|TWO_SIDED|95.0|14.7|48.2|||Cochran-Mantel-Haenszel|||||48.2|14.7|<0.001
70979041|NCT03878147|141466304|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 6.|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.02|TWO_SIDED|95.0|0.003|0.04||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.040|0.003|.02
71034881|NCT03100344|141579143|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.154|TWO_SIDED|95.0|-4.2|28.6|||Cochran-Mantel-Haenszel|||||28.6|-4.2|0.154
71034882|NCT03100344|141579144|SUPERIORITY||Mean Difference (Final Values)|10.9||||0.062|TWO_SIDED|95.0|-0.4|22.2|||Cochran-Mantel-Haenszel|||Week 1||22.2|-0.4|0.062
71034883|NCT03100344|141579144|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.042|TWO_SIDED|95.0|0.8|23.6|||Cochran-Mantel-Haenszel|||Week 1||23.6|0.8|0.042
71034884|NCT03100344|141579144|SUPERIORITY||Mean Difference (Final Values)|5.2||||0.307|TWO_SIDED|95.0|-4.7|15.0|||Cochran-Mantel-Haenszel|||Week 1||15.0|-4.7|0.307
71034885|NCT03100344|141579144|SUPERIORITY||Mean Difference (Final Values)|24.0||||0.003|TWO_SIDED|95.0|9.3|38.7|||Cochran-Mantel-Haenszel|||Week 2||38.7|9.3|0.003
71034886|NCT03100344|141579144|SUPERIORITY||Mean Difference (Final Values)|26.2||||0.001|TWO_SIDED|95.0|11.4|40.9|||Cochran-Mantel-Haenszel|||Week 2||40.9|11.4|0.001
71034887|NCT03100344|141579144|SUPERIORITY||Mean Difference (Final Values)|19.0||||0.011|TWO_SIDED|95.0|4.9|33.1|||Cochran-Mantel-Haenszel|||Week 2||33.1|4.9|0.011
71034888|NCT03100344|141579144|SUPERIORITY||Mean Difference (Final Values)|27.6|||<|0.001|TWO_SIDED|95.0|13.5|41.7|||Cochran-Mantel-Haenszel|||Week 4||41.7|13.5|<0.001
71034889|NCT03100344|141579144|SUPERIORITY||Mean Difference (Final Values)|40.3|||<|0.001|TWO_SIDED|95.0|25.7|54.8|||Cochran-Mantel-Haenszel|||Week 4||54.8|25.7|<0.001
71034890|NCT03100344|141579144|SUPERIORITY||Mean Difference (Final Values)|31.6|||<|0.001|TWO_SIDED|95.0|17.4|45.8|||Cochran-Mantel-Haenszel|||Week 4||45.8|17.4|<0.001
71034891|NCT03100344|141579144|SUPERIORITY||Mean Difference (Final Values)|20.6||||0.018|TWO_SIDED|95.0|4.2|37.1|||Cochran-Mantel-Haenszel|||Week 8||37.1|4.2|0.018
71034892|NCT03100344|141579144|SUPERIORITY||Mean Difference (Final Values)|43.7|||<|1|TWO_SIDED|95.0|27.6|59.9|||Cochran-Mantel-Haenszel|||Week 8||59.9|27.6|<0001
71034893|NCT03100344|141579144|SUPERIORITY||Mean Difference (Final Values)|26.1||||0.003|TWO_SIDED|95.0|9.7|42.6|||Cochran-Mantel-Haenszel|||Week 8||42.6|9.7|0.003
71034894|NCT03100344|141579144|SUPERIORITY||Mean Difference (Final Values)|24.4||||0.007|TWO_SIDED|95.0|7.3|41.4|||Cochran-Mantel-Haenszel|||Week 12||41.4|7.3|0.007
71034895|NCT03100344|141579144|SUPERIORITY||Mean Difference (Final Values)|43.6|||<|0.001|TWO_SIDED|95.0|27.4|59.9|||Cochran-Mantel-Haenszel|||Week 12||59.9|27.4|<0.001
71034896|NCT03100344|141579144|SUPERIORITY||Mean Difference (Final Values)|19.1||||0.03|TWO_SIDED|95.0|2.4|35.9|||Cochran-Mantel-Haenszel|||Week 12||35.9|2.4|0.030
71034897|NCT03100344|141579144|SUPERIORITY||Mean Difference (Final Values)|33.3|||<|0.001|TWO_SIDED|95.0|16.4|50.2|||Cochran-Mantel-Haenszel|||Week 16||50.2|16.4|<0.001
71034898|NCT03100344|141579144|SUPERIORITY||Mean Difference (Final Values)|47.2|||<|0.001|TWO_SIDED|95.0|31.2|63.2|||Cochran-Mantel-Haenszel|||Week 16||63.2|31.2|<0.001
71034899|NCT03100344|141579144|SUPERIORITY||Mean Difference (Final Values)|22.8||||0.01|TWO_SIDED|95.0|6.1|39.4|||Cochran-Mantel-Haenszel|||Week 16||39.4|6.1|0.010
71034900|NCT03100344|141579144|SUPERIORITY||Mean Difference (Final Values)|26.3||||0.004|TWO_SIDED|95.0|9.2|43.5|||Cochran-Mantel-Haenszel|||Week 20||43.5|9.2|0.004
70979042|NCT03878147|141466304|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.19|TWO_SIDED|95.0|-0.01|0.05||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.05|-0.01|.19
70979043|NCT03878147|141466304|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.19|TWO_SIDED|95.0|-0.01|0.04||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.04|-0.01|.19
70979044|NCT05817045|141466305|SUPERIORITY|adjusted for the following prognostic baseline covariates: baseline log10 nasopharyngeal viral load, ethnicity, hours since symptom onset, and baseline risk factor score|Hazard Ratio (HR)|1.01||||0.948|TWO_SIDED|95.0|0.777|1.31|||NPANCOVA||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19|NPANCOVA analysis for time to sustained resolution of COVID-19 signs and symptoms without subsequent recurrence or disease progression (until the end of the study) Full Analysis Set (FAS)||1.310|0.777|0.948
70979045|NCT05817045|141466305|SUPERIORITY|Per-Protocol Population|Hazard Ratio (HR)|1.02||||0.902|TWO_SIDED|95.0|0.774|1.337||adjusted for the following prognostic baseline covariates: baseline log10 nasopharyngeal viral load, ethnicity, hours since symptom onset, and baseline risk factor score.|NPANCOVA||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19|NPANCOVA analysis for time to sustained resolution of COVID-19 signs and symptoms without subsequent symptom recurrence or disease progression (until the end of the study) Per-Protocol Population||1.337|0.774|0.902
70979046|NCT05817045|141466305|SUPERIORITY|adjusted for the following prognostic baseline covariates: baseline log10 nasopharyngeal viral load, ethnicity, hours since symptom onset, and baseline risk factor score|Hazard Ratio (HR)|1.02||||0.859|TWO_SIDED|95.0|0.782|1.342|||NPANCOVA||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19;|NPANCOVA analysis for time to sustained resolution of COVID-19 signs and symptoms without subsequent symptom recurrence or disease progression (until the end of the study) - Secondary Analysis (FAS excluding subjects that were qPCR negative at baseline)||1.342|0.782|0.859
70979047|NCT05817045|141466307|SUPERIORITY|adjusted for the following prognostic baseline covariates: baseline log10 nasopharyngeal viral load, ethnicity, hours since symptom onset, and baseline risk factor score|Hazard Ratio (HR)|1.29||||0.017|TWO_SIDED|95.0|1.047|1.596|||NPANCOVA||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19|NPANCOVA analysis for time to first of two negative SARS-CoV-2 antigen tests (with a minimum time between tests of six hours) without subsequent virologic rebound (during the subject's remaining time on study) Full Analysis Set (FAS)||1.596|1.047|0.017
70979048|NCT05817045|141466307|SUPERIORITY|adjusted for the following prognostic baseline covariates: baseline log10 nasopharyngeal viral load, ethnicity, hours since symptom onset, and baseline risk factor score|Hazard Ratio (HR)|1.33||||0.014|TWO_SIDED|95.0|1.059|1.665|||NPANCOVA||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19;|NPANCOVA analysis for time to first of two negative SARS-CoV-2 antigen tests (with a minimum time between tests of six hours) without subsequent virological rebound (during the subject's remaining time on study) (Per-Protocol population)||1.665|1.059|0.014
71034901|NCT03100344|141579144|SUPERIORITY||Mean Difference (Final Values)|36.7|||<|0.001|TWO_SIDED|95.0|20.1|53.3|||Cochran-Mantel-Haenszel|||Week 20||53.3|20.1|<0.001
71034902|NCT03100344|141579144|SUPERIORITY||Mean Difference (Final Values)|24.5||||0.007|TWO_SIDED|95.0|7.6|41.4|||Cochran-Mantel-Haenszel|||Week 20||41.4|7.6|0.007
71096291|NCT02421510|141701429|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.003|TWO_SIDED|95.0|-0.7|-0.2||Threshold for significance \<= 0.05.|MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<=8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline DDS2 total score-by-time interaction as a covariate.||-0.2|-0.7|0.003
71034903|NCT03100344|141579144|SUPERIORITY||Mean Difference (Final Values)|20.9||||0.022|TWO_SIDED|95.0|3.6|38.1|||Cochran-Mantel-Haenszel|||Week 24||38.1|3.6|0.022
71034904|NCT03100344|141579144|SUPERIORITY||Mean Difference (Final Values)|24.3||||0.007|TWO_SIDED|95.0|7.4|41.3|||Cochran-Mantel-Haenszel|||Week 24||41.3|7.4|0.007
71034905|NCT03100344|141579144|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.05|TWO_SIDED|95.0|0.4|34.4|||Cochran-Mantel-Haenszel|||Week 24||34.4|0.4|0.050
71034906|NCT03100344|141579145|OTHER|mixed-effect model for repeated measures|mean difference of percentage changes|-14.4||||0.017|TWO_SIDED|95.0|-26.2|-2.7|||Kenward Roger|||||-2.7|-26.2|0.017
71034907|NCT03100344|141579145|OTHER|mixed-effect model for repeated measures|mean difference of percentage changes|-11.3||||0.058|TWO_SIDED|95.0|-23.1|0.4|||Kenward Roger|||||0.4|-23.1|0.058
71034908|NCT03100344|141579145|OTHER|mixed-effect model for repeated measures|mean difference of percentage changes|-20.0|||<|0.001|TWO_SIDED|95.0|-31.6|-8.3|||Kenward Roger|||||-8.3|-31.6|<0.001
71034909|NCT03100344|141579146|OTHER|mixed-effect model for repeated measures|mean difference of absolute changes|-9.6||||0.016|TWO_SIDED|95.0|-17.5|-1.8|||Kenward Roger|||||-1.8|-17.5|0.016
71034910|NCT03100344|141579146|OTHER|mixed-effect model for repeated measures|mean difference of absolute changes|-12.8||||0.001|TWO_SIDED|95.0|-20.6|-5.1|||Kenward Roger|||||-5.1|-20.6|0.001
70979049|NCT05817045|141466307|SUPERIORITY|adjusted for the following prognostic baseline covariates: baseline log10 nasopharyngeal viral load, ethnicity, hours since symptom onset, and baseline risk factor score|Hazard Ratio (HR)|1.35||||0.007|TWO_SIDED|95.0|1.086|1.69|||NPANCOVA||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19|NPANCOVA analysis for time to first of two negative SARS-CoV-2 antigen tests (with a minimum time between tests of six hours) without subsequent virological rebound (during the subject's remaining time on study) - Secondary analysis - (FAS excluding subjects that were qPCR negative at baseline)||1.690|1.086|0.007
70979050|NCT05817045|141466307|SUPERIORITY|SARS-CoV-2 rapid antigen test type: Flowflex|Cox Proportional Hazard|1.46|||||TWO_SIDED|95.0|1.064|1.997|||||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19|Cox proportional hazards model for time to first of two negative SARS-CoV-2 antigen tests (with a minimum time between tests of six hours) without subsequent virological rebound (during the subject's remaining time on study) (FAS)||1.997|1.064|
70979051|NCT05817045|141466307|SUPERIORITY|SARS-CoV-2 rapid antigen test type: BinaxNOW|Cox Proportional Hazard|1.12|||||TWO_SIDED|95.0|0.801|1.561|||||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19|Subgroup Analysis - Cox proportional hazards model for time to first of two negative SARS-CoV-2 antigen tests (with a minimum time between tests of six hours) without subsequent virological rebound (during the subject's remaining time on study) (FAS)||1.561|0.801|
70979052|NCT02073487|141466320|SUPERIORITY||||||<|0.01|||||||Fisher Exact|||||||<0.01
70979053|NCT00054847|141466323|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.82|TWO_SIDED|95.0|0.62|1.84||Multiple logistic regression analysis was used to adjust for stratification factors and characteristics that were potentially predictive of graft patency. We also performed prespecified subgroup analyses and assessed treatment subgroup interaction.|Chi-squared|We performed as-treated and per-protocol analyses \& multiple imputations as sensitivity analyses to the intent-to-treat analysis on primary end point.||The study was designed to have 90% power to detect 1-year patency rates of 92% in radial artery vs 83% in saphenous vein grafts, with a 2-sided type I error of 5%and an expected 1-year catheterization completion rate of 65%.||1.84|.62|.82
70979054|NCT00054847|141466324|SUPERIORITY_OR_OTHER|||||||0.61|||||||Chi-squared|||||||.61
70979055|NCT00054847|141466325|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Chi-squared|||||||>.99
70979056|NCT00619229|141466354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94||||0.122|TWO_SIDED|95.0|-0.674|2.55||The criterion for significance (α) was set at one-sided α = 0.025, which means that only an effect in the expected direction was interpreted.|ANCOVA||For exploratory testing an Analysis of Variance-Covariance (ANCOVA) F-test with dependent variable 'difference in visual acuity', fixed factors 'treatment' and 'centre' and Baseline value as a covariate was used.|"The primary goal of the study was to test the following null hypothesis:~H0: μAlprostadil ≤ μPlacebo, against the alternative hypothesis H1: μAlprostadil \> μPlacebo, where μ denotes the mean differences in visual acuity between measurements at 3 months after the end of study drug infusion minus measurements at baseline as assessed as line difference on the standard ETDRS charts."||2.55|-0.674|0.1220
70979057|NCT01157117|141466377|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|12.0||||0.42|TWO_SIDED|95.0|-13.4|37.3||No adjustments were made to the p-value.|Fisher Exact|The a priori threshold for statistical significance is 0.05.||Number of participants who successfully consumed 10,000 mg of milk protein followed by an open feeding of milk was compared using Fisher's Exact test with the null hypothesis that there was no difference between treatment groups.||37.3|-13.4|0.42
70979058|NCT02207907|141466408|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.491|||<|0.0001|TWO_SIDED|95.0|-20.317|-14.664|||ANCOVA|From ANCOVA analysis with treatment group and smoking status as factors and baseline MGI and BI as covariates|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||-14.664|-20.317|<0.0001
70979059|NCT02207907|141466409|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.201|||<|0.0001|TWO_SIDED|95.0|-0.237|-0.165|||ANCOVA|From ANCOVA analysis with treatment group and smoking status as factors and baseline MGI and BI as covariates|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||-0.165|-0.237|<0.0001
70979060|NCT02620020|141466414|SUPERIORITY||Least Squares (LS) Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.3876|TWO_SIDED|95.0|-0.88|0.34||Nominal p-value|Mixed Models Analysis|||||0.34|-0.88|0.3876
70979061|NCT02620020|141466414|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.018|TWO_SIDED|95.0|-1.32|-0.12||Nominal p-value|Mixed Models Analysis|||||-0.12|-1.32|0.0180
70979062|NCT02620020|141466414|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0288|TWO_SIDED|95.0|-1.26|-0.07||Nominal p-value|Mixed Models Analysis|||||-0.07|-1.26|0.0288
70979063|NCT02620020|141466416|SUPERIORITY||LS mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.73||0.0028|TWO_SIDED|95.0|-3.65|-0.77||Nominal p-value|Mixed Models Analysis|||||-0.77|-3.65|0.0028
70979064|NCT02620020|141466416|SUPERIORITY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.72||0.0068|TWO_SIDED|95.0|-3.36|-0.54||Nominal p-value|Mixed Models Analysis|||||-0.54|-3.36|0.0068
70979065|NCT02620020|141466416|SUPERIORITY||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.72||0.0006|TWO_SIDED|95.0|-3.88|-1.06||Nominal p-value|Mixed Models Analysis|||||-1.06|-3.88|0.0006
70979066|NCT02620020|141466417|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1501|TWO_SIDED|95.0|-0.46|0.07||Nominal p-value|Mixed Models Analysis|||||0.07|-0.46|0.1501
70979067|NCT02620020|141466417|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.2603|TWO_SIDED|95.0|-0.41|0.11||Nominal p-value|Mixed Models Analysis|||||0.11|-0.41|0.2603
70979068|NCT02620020|141466417|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0135|TWO_SIDED|95.0|-0.59|-0.07||Nominal p-value|Mixed Models Analysis|||||-0.07|-0.59|0.0135
70979069|NCT02537678|141466452|NON_INFERIORITY|We planned 0.41 standard deviation (SD) as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|1.43||0.006|ONE_SIDED|97.5|-3.26||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 SD units.|Treatment difference = standard Trauma Focused -CBT - stepped care Trauma Focused-CBT||-3.26|.006
70979070|NCT02537678|141466453|NON_INFERIORITY|We planned 0.41 standard deviation (SD) as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|1.49||0.004|ONE_SIDED|97.5|-3.47||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 SD units.|Treatment difference = standard Trauma Focused -CBT - stepped care Trauma Focused-CBT||-3.47|.004
70979071|NCT02537678|141466454|NON_INFERIORITY|We planned 0.41standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied 12-month assessment.|Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|1.2||0.001|ONE_SIDED|97.5|-2.5||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.|Treatment difference = standard TF-CBT - stepped care TF-CBT||-2.50|.001
70979072|NCT02537678|141466455|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|1.89|<|0.001|ONE_SIDED|97.5|-2.94||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.|Treatment difference = standard TF-CBT - stepped care TF-CBT||-2.94|<0.001
70979073|NCT02537678|141466456|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-1.89|STANDARD_ERROR_OF_MEAN|2.25||0.044|ONE_SIDED|97.5|-6.33||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.|Treatment difference = standard TF-CBT - stepped care TF-CBT||-6.33|.044
70979074|NCT02537678|141466457|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|1.75||0.002|ONE_SIDED|97.5|-3.07||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.|Treatment difference = standard TF-CBT - stepped care TF-CBT||-3.07|0.002
70979075|NCT02537678|141466458|NON_INFERIORITY|We planned 0.41 standard deviation (SD) as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-1.06|STANDARD_ERROR_OF_MEAN|1.52||0.016|ONE_SIDED|97.5|-4.06||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-4.06|0.016
70979076|NCT02537678|141466459|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|1.77||0.003|ONE_SIDED|97.5|-3.72||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.|Treatment difference = standard TF-CBT - stepped care TF-CBT||-3.72|0.003
70979077|NCT02537678|141466460|NON_INFERIORITY|We planned 0.41 standard deviation the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|1.89||0.007|ONE_SIDED|97.5|-3.89||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-3.89|0.007
70979078|NCT02537678|141466461|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|1.64||0.008|ONE_SIDED|97.5|-4.24||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-4.24|0.008
70979079|NCT02537678|141466462|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|1.78||0.015|ONE_SIDED|97.5|-4.88||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-4.88|0.015
70979080|NCT02537678|141466463|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|-1.75|STANDARD_ERROR_OF_MEAN|1.99||0.024|ONE_SIDED|97.5|-5.68||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-5.68|0.024
71034911|NCT03100344|141579146|OTHER|mixed-effect model for repeated measures|mean difference of absolute changes|-7.6||||0.058|TWO_SIDED|95.0|-15.4|0.3|||Kenward Roger|||||0.3|-15.4|0.058
71034912|NCT03100344|141579147|OTHER|mixed-effect model for repeated measures|mean difference of percentage changes|-24.5|||<|0.001|TWO_SIDED|95.0|-37.8|-11.2|||Kenward Roger|||||-11.2|-37.8|<0.001
71034913|NCT03100344|141579147|OTHER|mixed-effect model for repeated measures|mean difference of percentage changes|-31.7|||<|0.001|TWO_SIDED|95.0|-44.9|-18.6|||Kenward Roger|||||-18.6|-44.9|<0.001
71034914|NCT03100344|141579147|OTHER|mixed-effect model for repeated measures|mean difference of percentage changes|-25.1|||<|0.001|TWO_SIDED|95.0|-38.4|-11.8|||Kenward Roger|||||-11.8|-38.4|<0.001
71034915|NCT03100344|141579148|OTHER|mixed-effect model for repeated measures|mean difference of absolute changes|-2.0|||<|0.001|TWO_SIDED|95.0|-3.1|-1.0|||Kenward Roger|||||-1.0|-3.1|<0.001
70979081|NCT02537678|141466464|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.001|ONE_SIDED|97.5|-0.39||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-0.39|0.001
70979082|NCT02537678|141466465|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.22||0.003|ONE_SIDED|97.5|-0.47||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-0.47|0.003
70979083|NCT02537678|141466466|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|ONE_SIDED|97.5|-0.3||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-0.30|<0.001
70979084|NCT02537678|141466467|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.14||0.001|ONE_SIDED|97.5|-0.29||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-0.29|0.001
70979085|NCT02537678|141466468|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.16||0.004|ONE_SIDED|97.5|-0.38||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-0.38|0.004
70979086|NCT02537678|141466469|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|ONE_SIDED|97.5|-0.19||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-0.19|<0.001
71034916|NCT03100344|141579148|OTHER|mixed-effect model for repeated measures|mean difference of absolute changes|-2.3|||<|0.001|TWO_SIDED|95.0|-3.4|-1.3|||Kenward Roger|||||-1.3|-3.4|<0.001
71034917|NCT03100344|141579148|OTHER|mixed-effect model for repeated measures|mean difference of absolute changes|-1.9|||<|0.001|TWO_SIDED|95.0|-3.0|-0.9|||Kenward Roger|||||-0.9|-3.0|<0.001
71034918|NCT03100344|141579149|OTHER||Mean Difference (Final Values)|0.1||||0.97|TWO_SIDED|95.0|-4.9|5.1|||Cochran-Mantel-Haenszel|||At week 1||5.1|-4.9|0.970
70979087|NCT02537678|141466470|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|1.47||0.005|ONE_SIDED|97.5|-3.33||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-3.33|0.005
70979088|NCT02537678|141466471|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|1.78||0.028|ONE_SIDED|97.5|-4.99||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-4.99|0.028
71034919|NCT03100344|141579149|OTHER||Mean Difference (Final Values)|1.7||||0.574|TWO_SIDED|95.0|-4.1|7.5|||Cochran-Mantel-Haenszel|||At week 1||7.5|-4.1|0.574
71034920|NCT03100344|141579149|OTHER||Mean Difference (Final Values)|-1.8||||0.311|TWO_SIDED|95.0|-5.2|1.7|||Cochran-Mantel-Haenszel|||At week 1||1.7|-5.2|0.311
71034921|NCT03100344|141579149|OTHER||Mean Difference (Final Values)|4.2||||0.598|TWO_SIDED|95.0|-11.3|19.8|||Cochran-Mantel-Haenszel|||At week 24||19.8|-11.3|0.598
71034922|NCT03100344|141579149|OTHER||Mean Difference (Final Values)|15.5||||0.066|TWO_SIDED|95.0|-0.4|31.4|||Cochran-Mantel-Haenszel|||At week 24||31.4|-0.4|0.066
71034923|NCT03100344|141579149|OTHER||Mean Difference (Final Values)|1.7||||0.826|TWO_SIDED|95.0|-13.5|16.9|||Cochran-Mantel-Haenszel|||At week 24||16.9|-13.5|0.826
71034924|NCT03100344|141579149|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.558|TWO_SIDED|95.0|-7.7|4.1|||Cochran-Mantel-Haenszel|||Week 2||4.1|-7.7|0.558
71034925|NCT03100344|141579149|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.413|TWO_SIDED|95.0|-4.7|11.6|||Cochran-Mantel-Haenszel|||Week 2||11.6|-4.7|0.413
71034926|NCT03100344|141579149|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.543|TWO_SIDED|95.0|-7.7|4.0|||Cochran-Mantel-Haenszel|||Week 2||4.0|-7.7|0.543
71034927|NCT03100344|141579149|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.583|TWO_SIDED|95.0|-7.6|4.2|||Cochran-Mantel-Haenszel|||Week 4||4.2|-7.6|0.583
71034928|NCT03100344|141579149|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.028|TWO_SIDED|95.0|1.8|22.5|||Cochran-Mantel-Haenszel|||Week 4||22.5|1.8|0.028
71034929|NCT03100344|141579149|SUPERIORITY||Mean Difference (Final Values)|8.7||||0.087|TWO_SIDED|95.0|-0.9|18.3|||Cochran-Mantel-Haenszel|||Week 4||18.3|-0.9|0.087
71034930|NCT03100344|141579149|SUPERIORITY||Mean Difference (Final Values)|1.9||||0.632|TWO_SIDED|95.0|-5.6|9.4|||Cochran-Mantel-Haenszel|||Week 8||9.4|-5.6|0.632
71034931|NCT03100344|141579149|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.016|TWO_SIDED|95.0|3.1|24.8|||Cochran-Mantel-Haenszel|||Week 8||24.8|3.1|0.016
71034932|NCT03100344|141579149|SUPERIORITY||Mean Difference (Final Values)|15.8||||0.009|TWO_SIDED|95.0|4.5|27.0|||Cochran-Mantel-Haenszel|||Week 8||27.0|4.5|0.009
71034933|NCT03100344|141579149|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.974|TWO_SIDED|95.0|-11.2|11.6|||Cochran-Mantel-Haenszel|||Week 12||11.6|-11.2|0.974
71034934|NCT03100344|141579149|SUPERIORITY||Mean Difference (Final Values)|15.6||||0.031|TWO_SIDED|95.0|1.8|29.3|||Cochran-Mantel-Haenszel|||Week 12||29.3|1.8|0.031
71096292|NCT04053452|141701464|OTHER||Area under the curve|0.7262|||||TWO_SIDED||||||||Area under the receiver operating characteristic (ROC) curve.|||||
70979089|NCT02537678|141466472|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|1.62||0.009|ONE_SIDED|97.5|-3.64||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-3.64|0.009
70979090|NCT02537678|141466473|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.9||0.006|ONE_SIDED|97.5|-2.82||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-2.82|0.006
70979091|NCT02537678|141466474|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.88||0.001|ONE_SIDED|97.5|-2.31||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-2.31|0.001
70979092|NCT02537678|141466475|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Median Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.83|<|0.001|ONE_SIDED|97.5|-1.43||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-1.43|<0.001
70979093|NCT02537678|141466476|NON_INFERIORITY|For the non-inferiority margin for the PCL-5, the clinically significant change threshold is 10 points although adult PTSD trials have used -5 to -10 points. We used -8.8 as the margin which was based on an expert panel and prior studies with adults. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|2.16|<|0.001|ONE_SIDED|97.5|-5.04||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-5.04|<0.001
70979094|NCT02537678|141466477|NON_INFERIORITY|For the non-inferiority margin for the PCL-5, the clinically significant change threshold is 10 points although adult PTSD trials have used -5 to -10 points. We used -8.8 as the margin which was based on an expert panel and prior studies with adults. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|2.27||0.003|ONE_SIDED|97.5|-6.87||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-6.87|0.003
70979095|NCT02537678|141466478|NON_INFERIORITY|For the non-inferiority margin for the PCL-5, the clinically significant change threshold is 10 points although adult PTSD trials have used -5 to -10 points. We used -8.8 as the margin which was based on an expert panel and prior studies with adults.Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|-1.74|STANDARD_ERROR_OF_MEAN|2.06|<|0.001|ONE_SIDED|97.5|-5.8||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-5.80|<0.001
70979096|NCT01147809|141466519|SUPERIORITY_OR_OTHER||Percent difference|21.1||||0.103|TWO_SIDED|95.0|-3.9|52.5|||ANCOVA|||||52.5|-3.9|0.103
70979097|NCT01147809|141466541|SUPERIORITY_OR_OTHER||Percent difference|12.9||||0.407|TWO_SIDED|95.0|-15.6|51.1|||ANCOVA|||||51.1|-15.6|0.407
70979098|NCT01147809|141466542|SUPERIORITY_OR_OTHER||Percent difference|-4.4||||0.802|TWO_SIDED|95.0|-33.5|37.4|||ANCOVA|||||37.4|-33.5|0.802
70979099|NCT01307423|141466550|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|12.1||||0.0062|TWO_SIDED|95.0|3.5|20.7|||Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||20.7|3.5|0.0062
70979100|NCT01307423|141466550|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|14.8||||0.001|TWO_SIDED|95.0|6.1|23.5|||Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||23.5|6.1|0.0010
70979101|NCT01307423|141466551|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.168||||0.0008|TWO_SIDED|95.0|-0.265|-0.071|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group as a factor, and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.071|-0.265|0.0008
70979102|NCT01307423|141466551|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.217|||<|0.0001|TWO_SIDED|95.0|-0.314|-0.12|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group as a factor, and the baseline value as a covariate||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.120|-0.314|<.0001
71096293|NCT04053452|141701465|OTHER||Area under the curve|0.6667|||||TWO_SIDED||||||||Area under the receiver operating characteristic (ROC) curve.|||||
71096294|NCT04053452|141701466|OTHER||Area under the curve|0.7083|||||TWO_SIDED||||||||Area under the receiver operating characteristic (ROC) curve.|||||
71096295|NCT04053452|141701467|OTHER|Median at wrist|Kendall's tau correlation coefficient|-0.0623|||||TWO_SIDED|95.0|-0.5005|0.4791||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.4791|-0.5005|
70979103|NCT01307423|141466552|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|16.1||||0.0002|TWO_SIDED|95.0|7.7|24.4||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||24.4|7.7|0.0002
70979104|NCT01307423|141466552|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.4||||0.0063|TWO_SIDED|95.0|3.3|19.4||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||19.4|3.3|0.0063
70979105|NCT01307423|141466553|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.168||||0.0014|TWO_SIDED|95.0|-0.271|-0.065||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA|Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and baseline value as a covariate||||-0.065|-0.271|0.0014
70979106|NCT01307423|141466553|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.219|||<|0.0001|TWO_SIDED|95.0|-0.322|-0.117||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA|Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and baseline value as a covariate||||-0.117|-0.322|<.0001
70979107|NCT01307423|141466554|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.38||||0.0043|TWO_SIDED|95.0|0.75|4.01||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and baseline value as a covariate||||4.01|0.75|0.0043
70979108|NCT01307423|141466554|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.18||||0.0002|TWO_SIDED|95.0|1.55|4.82||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA|Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and baseline value as a covariate||||4.82|1.55|0.0002
70979109|NCT01307423|141466555|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|14.4||||0.0037|TWO_SIDED|95.0|4.8|24.0||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||24.0|4.8|0.0037
70979110|NCT01307423|141466555|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|21.0|||<|0.0001|TWO_SIDED|95.0|11.3|30.7||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||30.7|11.3|<.0001
70979111|NCT01307423|141466556|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.0||||0.0485|TWO_SIDED|95.0|-10.0|0.0||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group as a factor, and the baseline value as a covariate||||-0.0|-10.0|0.0485
70979112|NCT01307423|141466556|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.8||||0.0022|TWO_SIDED|95.0|-12.8|-2.8||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group as a factor, and the baseline value as a covariate||||-2.8|-12.8|0.0022
70979113|NCT01307423|141466557|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.7696|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||0.6|-0.8|0.7696
70979114|NCT01307423|141466557|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0||||0.0038|TWO_SIDED|95.0|-1.7|-0.3||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-0.3|-1.7|0.0038
70979115|NCT01307423|141466558|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|||||TWO_SIDED|95.0|-1.6|-0.2|||||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-0.2|-1.6|
70979116|NCT01307423|141466558|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|||||TWO_SIDED|95.0|-1.4|0.0|||||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-0.0|-1.4|
71096296|NCT04053452|141701467|OTHER|Median at forearm|Kendall's tau correlation coefficient|-0.1628|||||TWO_SIDED|95.0|-0.6503|0.4222||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.4222|-0.6503|
70979117|NCT01307423|141466559|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.91|||||TWO_SIDED|95.0|-7.04|-2.78|||||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-2.78|-7.04|
70979118|NCT01307423|141466559|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.65|||||TWO_SIDED|95.0|-7.78|-3.51|||||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-3.51|-7.78|
70979119|NCT01307423|141466560|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|||<|0.0001|TWO_SIDED|95.0|-0.67|-0.25|||ANCOVA||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-0.25|-0.67|<0.0001
71096297|NCT04053452|141701467|OTHER|Median at cubital fossa|Kendall's tau correlation coefficient|-0.185|||||TWO_SIDED|95.0|-0.549|0.1829||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.1829|-0.5490|
71096298|NCT04053452|141701467|OTHER|Median at humerus|Kendall's tau correlation coefficient|0.0512|||||TWO_SIDED|95.0|-0.3411|0.5017||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.5017|-0.3411|
70979120|NCT01307423|141466560|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.74|-0.32|||ANCOVA||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-0.32|-0.74|<0.0001
70979121|NCT01307423|141466561|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|1.12|||||TWO_SIDED|95.0|-0.63|2.87|||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||2.87|-0.63|
70979122|NCT01307423|141466561|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|2.55|||||TWO_SIDED|95.0|0.8|4.31|||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||4.31|0.80|
70979123|NCT01307423|141466562|SUPERIORITY_OR_OTHER_LEGACY||LS Means Difference|1.97|||||TWO_SIDED|95.0|0.28|3.65|||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||3.65|0.28|
70979124|NCT01307423|141466562|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.72|||||TWO_SIDED|95.0|2.02|5.41|||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||5.41|2.02|
70979125|NCT01307423|141466563|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|19.5|||||TWO_SIDED|95.0|10.5|28.6|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||28.6|10.5|
70979126|NCT01307423|141466563|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|18.2|||||TWO_SIDED|95.0|9.2|27.2|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||27.2|9.2|
70979127|NCT01307423|141466564|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.6|||||TWO_SIDED|95.0|-10.6|-0.5|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||-0.5|-10.6|
70979128|NCT01307423|141466564|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.7|||||TWO_SIDED|95.0|-10.8|-0.7|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||-0.7|-10.8|
70979129|NCT01307423|141466565|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|||||TWO_SIDED|95.0|-1.0|0.4|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||0.4|-1.0|
70979130|NCT01307423|141466565|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|||||TWO_SIDED|95.0|-1.6|-0.2|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||-0.2|-1.6|
70979131|NCT01307423|141466566|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|||||TWO_SIDED|95.0|-1.7|-0.3|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||-0.3|-1.7|
70979132|NCT01307423|141466566|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6|||||TWO_SIDED|95.0|-1.4|0.1|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||0.1|-1.4|
70979133|NCT01307423|141466567|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.07|||||TWO_SIDED|95.0|-7.31|-2.84|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||-2.84|-7.31|
70979134|NCT01307423|141466567|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.14|||||TWO_SIDED|95.0|-7.38|-2.89|||||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||-2.89|-7.38|
70979135|NCT01307423|141466568|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.23|||ANCOVA||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||-0.23|-0.70|<0.0001
70979136|NCT01307423|141466568|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46||||0.0001|TWO_SIDED|95.0|-0.69|-0.22|||ANCOVA||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||-0.22|-0.69|0.0001
70979137|NCT01307423|141466569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.12|||||TWO_SIDED|95.0|-0.68|2.93|||||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||2.93|-0.68|
70979138|NCT01307423|141466569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.33|||||TWO_SIDED|95.0|0.52|4.15|||||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||4.15|0.52|
70979139|NCT01307423|141466570|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|2.6|||||TWO_SIDED|95.0|-10.2|15.5|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||15.5|-10.2|
70979140|NCT01307423|141466570|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|17.0|||||TWO_SIDED|95.0|4.2|29.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||29.8|4.2|
70979141|NCT01307423|141466571|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|6.3|||||TWO_SIDED|95.0|-7.8|20.4|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||20.4|-7.8|
70979142|NCT01307423|141466571|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|1.9|||||TWO_SIDED|95.0|-12.6|16.4|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||16.4|-12.6|
70979143|NCT01307423|141466572|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|16.1|||||TWO_SIDED|95.0|6.4|25.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||25.8|6.4|
70979144|NCT01307423|141466572|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|19.3|||||TWO_SIDED|95.0|9.6|29.1|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||29.1|9.6|
70979145|NCT01307423|141466573|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|6.0|||||TWO_SIDED|95.0|-6.8|18.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||18.8|-6.8|
70979146|NCT01307423|141466573|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|18.0|||||TWO_SIDED|95.0|5.3|30.6|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||30.6|5.3|
70979147|NCT01307423|141466574|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.9|||||TWO_SIDED|95.0|-2.1|25.9|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||25.9|-2.1|
70979148|NCT01307423|141466574|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|5.3|||||TWO_SIDED|95.0|-9.2|19.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||19.8|-9.2|
70979149|NCT01307423|141466575|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|17.8|||||TWO_SIDED|95.0|8.8|26.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||26.8|8.8|
70979150|NCT01307423|141466575|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.4|||||TWO_SIDED|95.0|2.7|20.0|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||20.0|2.7|
70979151|NCT01307423|141466576|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|6.9|||||TWO_SIDED|95.0|1.3|12.5|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||12.5|1.3|
70979152|NCT01307423|141466576|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|6.8|||||TWO_SIDED|95.0|1.2|12.4|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||12.4|1.2|
71034935|NCT03100344|141579149|SUPERIORITY||Mean Difference (Final Values)|13.9||||0.032|TWO_SIDED|95.0|-0.3|28.2|||Cochran-Mantel-Haenszel|||Week 12||28.2|-0.3|0.032
71034936|NCT03100344|141579149|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.553|TWO_SIDED|95.0|-9.0|16.9|||Cochran-Mantel-Haenszel|||Week 16||16.9|-9.0|0.553
71034937|NCT03100344|141579149|SUPERIORITY||Mean Difference (Final Values)|20.9||||0.008|TWO_SIDED|95.0|6.1|35.8|||Cochran-Mantel-Haenszel|||Week 16||35.8|6.1|0.008
71034938|NCT03100344|141579149|SUPERIORITY||Mean Difference (Final Values)|13.9||||0.061|TWO_SIDED|95.0|-0.3|28.2|||Cochran-Mantel-Haenszel|||Week 16||28.2|-0.3|0.061
71034939|NCT03100344|141579149|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.585|TWO_SIDED|95.0|-10.1|18.0|||Cochran-Mantel-Haenszel|||Week 20||18.0|-10.1|0.585
71034940|NCT03100344|141579149|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.032|TWO_SIDED|95.0|2.0|32.8|||Cochran-Mantel-Haenszel|||Week 20||32.8|2.0|0.032
71096299|NCT04053452|141701467|OTHER|Median at axilla|Kendall's tau correlation coefficient|0.0476|||||TWO_SIDED|95.0|-0.4335|0.5592||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.5592|-0.4335|
71096300|NCT04053452|141701467|OTHER|Ulnar at wrist|Kendall's tau correlation coefficient|-0.1229|||||TWO_SIDED|95.0|-0.5092|0.304||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.3040|-0.5092|
70979153|NCT01307423|141466577|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|2.9|||||TWO_SIDED|95.0|-0.4|6.2|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||6.2|-0.4|
70979154|NCT01307423|141466577|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|2.8|||||TWO_SIDED|95.0|-0.4|6.1|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||6.1|-0.4|
70979155|NCT01307423|141466578|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|9.8|||||TWO_SIDED|95.0|3.2|16.3|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||16.3|3.2|
70979156|NCT01307423|141466578|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|6.3|||||TWO_SIDED|95.0|0.2|12.3|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||12.3|0.2|
70979157|NCT01307423|141466579|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-4.1|4.1|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||4.1|-4.1|
70979158|NCT01307423|141466579|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.6|||||TWO_SIDED|95.0|-3.7|4.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||4.8|-3.7|
70979159|NCT01307423|141466580|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|2.2|||||TWO_SIDED|95.0|-8.1|12.6|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||12.6|-8.1|
70979160|NCT01307423|141466580|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|17.8|||||TWO_SIDED|95.0|6.3|29.3|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||29.3|6.3|
71034941|NCT03100344|141579149|SUPERIORITY||Mean Difference (Final Values)|8.6||||0.254|TWO_SIDED|95.0|-5.9|23.1|||Cochran-Mantel-Haenszel|||Week 20||23.1|-5.9|0.254
71034942|NCT03100344|141579150|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.487|TWO_SIDED|95.0|-6.8|14.3|||Cochran-Mantel-Haenszel|||Week 1||14.3|-6.8|0.487
71034943|NCT03100344|141579150|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.033|TWO_SIDED|95.0|1.6|26.5|||Cochran-Mantel-Haenszel|||Week 1||26.5|1.6|0.033
71034944|NCT03100344|141579150|SUPERIORITY||Mean Difference (Final Values)|12.0||||0.053|TWO_SIDED|95.0|0.2|23.8|||Cochran-Mantel-Haenszel|||Week 1||23.8|0.2|0.053
71034945|NCT03100344|141579150|SUPERIORITY||Mean Difference (Final Values)|18.5||||0.021|TWO_SIDED|95.0|3.2|33.8|||Cochran-Mantel-Haenszel|||Week 2||33.8|3.2|0.021
71034946|NCT03100344|141579150|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.027|TWO_SIDED|95.0|2.4|32.3|||Cochran-Mantel-Haenszel|||Week 2||32.3|2.4|0.027
71034947|NCT03100344|141579150|SUPERIORITY||Mean Difference (Final Values)|22.7||||0.006|TWO_SIDED|95.0|7.3|38.1|||Cochran-Mantel-Haenszel|||Week 2||38.1|7.3|0.006
71034948|NCT03100344|141579150|SUPERIORITY||Mean Difference (Final Values)|15.2||||0.086|TWO_SIDED|95.0|-1.7|32.2|||Cochran-Mantel-Haenszel|||Week 4||32.2|-1.7|0.086
71096301|NCT04053452|141701467|OTHER|Ulnar at forearm|Kendall's tau correlation coefficient|0.0603|||||TWO_SIDED|95.0|-0.3057|0.4137||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.4137|-0.3057|
71096302|NCT04053452|141701467|OTHER|Ulnar at cubital fossa|Kendall's tau correlation coefficient|0.1059|||||TWO_SIDED|95.0|-0.4028|0.57||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.5700|-0.4028|
70979161|NCT01307423|141466581|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|9.4|||||TWO_SIDED|95.0|-4.8|23.5|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||23.5|-4.8|
70979162|NCT01307423|141466581|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|7.1|||||TWO_SIDED|95.0|-7.2|21.5|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||21.5|-7.2|
70979163|NCT01307423|141466582|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|6.5|||||TWO_SIDED|95.0|-4.8|17.7|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||17.7|-4.8|
70979164|NCT01307423|141466582|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|15.2|||||TWO_SIDED|95.0|3.4|27.1|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||27.1|3.4|
70979165|NCT01307423|141466583|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|10.5|||||TWO_SIDED|95.0|-3.8|24.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||24.8|-3.8|
70979166|NCT01307423|141466583|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|4.9|||||TWO_SIDED|95.0|-9.5|19.3|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||19.3|-9.5|
70979167|NCT01499290|141466606|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was determined by comparing the lower limit of the 95% confidence interval for risk difference (corresponding to a 97.5% 1-sided lower bound) to the non-inferiority marging of -12.5%|Risk Difference (RD)|-3.5|||||TWO_SIDED|95.0|-8.64|1.58||||||The primary objective of this study (FDA agreed) was to determine the noninferiority in the clinical cure rate for CAZ-AVI compared to that for Meropenem at TOC in the mMITT in adult subjects with cIAI.||1.58|-8.64|
70979168|NCT01499290|141466607|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was determined by comparing the lower limit of the 95% confidence interval for risk difference (corresponding to a 97.5% 1-sided lower bound) to the non-inferiority marging of -12.5%|Risk Difference (RD)|-2.4|||||TWO_SIDED|95.0|-6.9|2.1||||||The co-primary objective of this study (ROW agreed) was to determine the noninferiority in the clinical cure rate for CAZ-AVI compared to that for Meropenem at TOC in the MITT in adult subjects with cIAI.||2.10|-6.90|
70979169|NCT01499290|141466608|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was determined by comparing the lower limit of the 95% confidence interval for risk difference (corresponding to a 97.5% 1-sided lower bound) to the non-inferiority marging of -12.5%|Risk Difference (RD)|-0.8|||||TWO_SIDED|95.0|-4.61|2.89||||||The co-primary objective of this study (ROW agreed) was to determine the noninferiority in the clinical cure rate for CAZ-AVI compared to that for Meropenem at TOC in the CE in adult subjects with cIAI.||2.89|-4.61|
70979170|NCT00700804|141466661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7|STANDARD_DEVIATION|2.5||0.05|||||||Mixed Models Analysis|Effects of calcium (Ca), protein \& their interaction were tested using repeated measures analysis of variance (subjects nested under High or Low Ca)|Reported analysis is the main effect of Calcium (High vs Low) from the Mixed Model Analysis which averages across the two levels of dietary protein. The main effect of protein and the calcium x protein interaction were not statistically significant.|||||0.05
71096303|NCT04053452|141701467|OTHER|Ulnar at humerus|Kendall's tau correlation coefficient|-0.1786|||||TWO_SIDED|95.0|-0.6503|0.2838||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.2838|-0.6503|
70979171|NCT01511445|141466662|NON_INFERIORITY|The noninferiority margin was specified as 15 NDI points (0-100 scale).|Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|2.96||0.641|TWO_SIDED|95.0|-7.3|4.5|||Fisher Exact||A negative value means that the PEEK change was slightly larger than the silicon nitride study arm.|The null hypothesis was that the mean change in NDI scores from pre-op to 24 months was equal in the two study arms.||4.5|-7.3|0.641
70979172|NCT01511445|141466663|NON_INFERIORITY|The definition of fusion is rotation on flexion-extension films of less than or equal to four degrees and translation less than 1.25 mm.||||||0.71|||||||Fisher Exact|||The null hypothesis was that the fusion rates would be equal in the two study arms. The comparison includes patients with flexion-extension films at 24 months (as-treated population).||||0.710
70979173|NCT01252966|141466722|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.14|TWO_SIDED|95.0|0.42|1.13|||Regression, Logistic|||Longitudinal logistic regression with fitted generalized estimating equations (GEE) was used to estimate an overall treatment effect odds ratio including both the EOT and 6-month time points and relevant covariates (e.g., baseline smoking rate, age, Shipley IQ score). The study (n=213) had 80% power to detect small to medium effects on quit rates (corresponding to Cohen's one-sample d=0.38).||1.13|0.42|0.14
70979174|NCT01252966|141466724|SUPERIORITY_OR_OTHER|||||||0.3|||||||Regression, Linear|||Multiple regression models were used to estimate effects of treatment on change in cognitive performance. Age, Shipley IQ score, number of cigarettes smoked per day at baseline, and EOT smoking status were included as covariates.||||0.30
70979175|NCT01252966|141466725|SUPERIORITY_OR_OTHER|||||||0.3|||||||Regression, Linear|||Multiple regression models were used to estimate effects of treatment on change in cognitive performance. Age, Shipley IQ score, number of cigarettes smoked per day at baseline, and EOT smoking status were included as covariates.||||0.30
70979176|NCT01252966|141466726|SUPERIORITY_OR_OTHER|||||||0.033||||||Results would not survive correction for multiple hypothesis testing.|Regression, Linear|||Multiple regression models were used to estimate effects of treatment on change in cognitive performance. Age, Shipley IQ score, number of cigarettes smoked per day at baseline, and EOT smoking status were included as covariates.||||0.033
70979177|NCT03275870|141466727|OTHER|||||||0.042||||||p value \<0.05 used as threshold for significance|t-test, 2 sided|||||||0.042
70979178|NCT03275870|141466728|OTHER|||||||0.213||||||P value of \<0.05 used as threshold for significance|t-test, 2 sided|||||||0.213
70979179|NCT02240134|141466734|SUPERIORITY||Odds Ratio (OR)|1.23||||0.68|TWO_SIDED|95.0|0.46|3.32|||Mixed Models Analysis||Odds ratio for air filter treatment relative to placebo|Mixed effects logistic regression model with presence of LRTI as outcome (yes or no); assigned treatment as primary exposure variable relative to placebo; adjusted for child age and person-time at-risk; nested random term: home:cohort:area. Results presented as odds ratios with 95% Confidence Intervals.||3.32|0.46|0.68
71096304|NCT04053452|141701467|OTHER|Ulnar at axilla|Kendall's tau correlation coefficient|-0.2396|||||TWO_SIDED|95.0|-0.5714|0.195||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.1950|-0.5714|
70979180|NCT02240134|141466734|SUPERIORITY||Odds Ratio (OR)|0.98||||0.96|TWO_SIDED|95.0|0.35|2.72|||Mixed Models Analysis||Odds ratio for filter treatment relative to placebo|Mixed effects logistic regression model with presence of LRTI as outcome (yes or no); assigned treatment as primary exposure variable relative to placebo; adjusted for child age and person-time at-risk; nested random term: home:cohort:area. Results presented as odds ratios with 95% Confidence Intervals.||2.72|0.35|0.96
70979181|NCT02240134|141466735|SUPERIORITY||percent differences in geometric mean PM|-6.96||||0.25|TWO_SIDED|95.0|-30.5|24.55|||Mixed Models Analysis|||Linear mixed model with natural-log transformed 6-day mean indoor PM2.5 as outcome; assigned treatment as primary exposure variable; adjusted for child age; nested random term: cohort:area. Results presented as effect estimates with 95% Confidence Intervals and reported as percent differences in geometric mean PM2.5.||24.55|-30.50|0.250
70979182|NCT02240134|141466735|SUPERIORITY||percent differences in geometric mean PM|11.77||||0.295|TWO_SIDED|95.0|-16.57|49.72||Statistical significance selected as 95% confidence interval of the estimation parameter that excludes the null value, 0.|Mixed Models Analysis||Difference in indoor PM2.5 for education treatment versus placebo.|Linear mixed model with natural-log transformed 6-day mean indoor PM2.5 as outcome; assigned treatment as primary exposure variable; adjusted for child age; nested random term: cohort:area. Results presented as effect estimates with 95% Confidence Intervals and reported as percent differences in geometric mean PM2.5.||49.72|-16.57|0.295
70979183|NCT00206726|141466736|SUPERIORITY_OR_OTHER||CR rate|0.0833||||0.014||90.0|0.0334|0.1673||2-sided p-value computed from an exact binomial test comparing the observed rate versus 2% historical rate|exact binomial test|||Comparison of CR rate versus 2 percent (%) historic control (p-value and 90% confidence interval)||0.1673|0.0334|0.014
70979184|NCT02091440|141466758|OTHER|Single group|Proportion|100.0|||||TWO_SIDED|95.0||||||||||||
71034949|NCT03100344|141579150|SUPERIORITY||Mean Difference (Final Values)|26.2||||0.004|TWO_SIDED|95.0|9.3|43.1|||Cochran-Mantel-Haenszel|||Week 4||43.1|9.3|0.004
71034950|NCT03100344|141579150|SUPERIORITY||Mean Difference (Final Values)|17.3||||0.05|TWO_SIDED|95.0|0.5|34.2|||Cochran-Mantel-Haenszel|||Week 4||34.2|0.5|0.050
71034951|NCT03100344|141579150|SUPERIORITY||Mean Difference (Final Values)|20.7||||0.023|TWO_SIDED|95.0|3.3|38.1|||Cochran-Mantel-Haenszel|||Week 8||38.1|3.3|0.023
71034952|NCT03100344|141579150|SUPERIORITY||Mean Difference (Final Values)|27.9||||0.002|TWO_SIDED|95.0|10.7|45.0|||Cochran-Mantel-Haenszel|||Week 8||45.0|10.7|0.002
71034953|NCT03100344|141579150|SUPERIORITY||Mean Difference (Final Values)|27.9||||0.002|TWO_SIDED|95.0|10.7|45.0|||Cochran-Mantel-Haenszel|||Week 8||45.0|10.7|0.002
71034954|NCT03100344|141579150|SUPERIORITY||Mean Difference (Final Values)|19.3||||0.041|TWO_SIDED|95.0|1.3|37.3|||Cochran-Mantel-Haenszel|||Week 12||37.3|1.3|0.041
71034955|NCT03100344|141579150|SUPERIORITY||Mean Difference (Final Values)|27.9||||0.003|TWO_SIDED|95.0|10.4|45.4|||Cochran-Mantel-Haenszel|||Week 12||45.4|10.4|0.003
71034956|NCT03100344|141579150|SUPERIORITY||Mean Difference (Final Values)|17.3||||0.063|TWO_SIDED|95.0|-0.5|35.2|||Cochran-Mantel-Haenszel|||Week 12||35.2|-0.5|0.063
71096305|NCT04053452|141701467|OTHER|C6|Kendall's tau correlation coefficient|-0.0671|||||TWO_SIDED|95.0|-0.4667|0.3336||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.3336|-0.4667|
70979185|NCT02091440|141466759|OTHER|Single group|Kaplan-Meier Survival|100.0|||||TWO_SIDED|||||||||||||
70979186|NCT02091440|141466760|OTHER|Single group|Incidence|1.24|||||TWO_SIDED|||||||||||||
70979187|NCT02091440|141466761|OTHER|Single group|Incidence|1.66|||||TWO_SIDED|||||||||||||
70979188|NCT02091440|141466762|OTHER|Single group|Change from baseline|19.4|STANDARD_DEVIATION|11.39|||TWO_SIDED|95.0|7.5|31.4|||||Confidence interval based on t-distribution.|||31.4|7.5|
70979189|NCT02091440|141466763|OTHER|Single group|Percentage change|-83.33|||||TWO_SIDED||||||||Percentage change from 24 months to screening in NYHA classes III and IV. Percentage change is 16.67% - 100% = -83.33%|||||
70979190|NCT02091440|141466764|OTHER|Single group|Change from baseline|130.0|STANDARD_DEVIATION|275.32|||TWO_SIDED|95.0|-158.9|418.9|||||Confidence interval based on t-distribution.|||418.9|-158.9|
70979191|NCT03576144|141466775|OTHER||Slope|1.0474|STANDARD_ERROR_OF_MEAN|0.0283|||TWO_SIDED|90.0|0.9997|1.0951|||ANCOVA||Standard Error of the mean is actually standard error of slope.Based on the estimate for the slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|Dose proportionality for AUC0-12 of BI 1265162 in plasma was assessed using a power model (regression model applied to log-transformed data). The corresponding ANCOVA model included the logarithm of the dose as a covariate. No statistical hypotheses were tested in a confirmatory sense.||1.0951|0.9997|
71034957|NCT03100344|141579150|SUPERIORITY||Mean Difference (Final Values)|17.6||||0.064|TWO_SIDED|95.0|-0.4|35.6|||Cochran-Mantel-Haenszel|||Week 16||35.6|-0.4|0.064
71034958|NCT03100344|141579150|SUPERIORITY||Mean Difference (Final Values)|22.6||||0.016|TWO_SIDED|95.0|4.9|40.3|||Cochran-Mantel-Haenszel|||Week 16||40.3|4.9|0.016
71034959|NCT03100344|141579150|SUPERIORITY||Mean Difference (Final Values)|19.1||||0.041|TWO_SIDED|95.0|1.3|36.9|||Cochran-Mantel-Haenszel|||Week 16||36.9|1.3|0.041
71034960|NCT03100344|141579150|SUPERIORITY||Mean Difference (Final Values)|17.6||||0.064|TWO_SIDED|95.0|-0.4|35.6|||Cochran-Mantel-Haenszel|||Week 20||35.6|-0.4|0.064
71034961|NCT03100344|141579150|SUPERIORITY||Mean Difference (Final Values)|26.0||||0.005|TWO_SIDED|95.0|8.6|43.4|||Cochran-Mantel-Haenszel|||Week 20||43.4|8.6|0.005
71034962|NCT03100344|141579150|SUPERIORITY||Mean Difference (Final Values)|17.2||||0.064|TWO_SIDED|95.0|-0.6|35.0|||Cochran-Mantel-Haenszel|||Week 20||35.0|-0.6|0.064
71034963|NCT03100344|141579150|SUPERIORITY||Mean Difference (Final Values)|15.9||||0.094|TWO_SIDED|95.0|-2.0|33.8|||Cochran-Mantel-Haenszel|||Week 24||33.8|-2.0|0.094
71034964|NCT03100344|141579150|SUPERIORITY||Mean Difference (Final Values)|22.4||||0.014|TWO_SIDED|95.0|5.1|39.6|||Cochran-Mantel-Haenszel|||Week 24||39.6|5.1|0.014
71034965|NCT03100344|141579150|SUPERIORITY||Mean Difference (Final Values)|10.2||||0.273|TWO_SIDED|95.0|-7.7|28.0|||Cochran-Mantel-Haenszel|||Week 24||28.0|-7.7|0.273
71034966|NCT03100344|141579151|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.979|TWO_SIDED|95.0|-6.8|7.0|||Cochran-Mantel-Haenszel|||Week 1||7.0|-6.8|0.979
71096306|NCT04053452|141701467|OTHER|C7|Kendall's tau correlation coefficient|-0.2134|||||TWO_SIDED|95.0|-0.7018|0.3193||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.3193|-0.7018|
71034967|NCT03100344|141579151|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.668|TWO_SIDED|95.0|-5.8|9.0|||Cochran-Mantel-Haenszel|||Week 1||9.0|-5.8|0.668
70979192|NCT03576144|141466776|OTHER||Slope|1.0091|STANDARD_ERROR_OF_MEAN|0.038|||TWO_SIDED|90.0|0.9451|1.0732|||ANCOVA||Standard Error of the is actually standard error of slope. Based on the estimate for the slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|Dose proportionality for Cmax of BI 1265162 in plasma was assessed using a power model (regression model applied to log-transformed data). The corresponding ANCOVA model included the logarithm of the dose as a covariate. No statistical hypotheses were tested in a confirmatory sense.||1.0732|0.9451|
70979193|NCT03576144|141466777|OTHER||Slope|1.052|STANDARD_ERROR_OF_MEAN|0.0325|||TWO_SIDED|90.0|0.9972|1.1069|||ANCOVA||Standard Error of the mean is actually standard error of slope. Based on the estimate for the slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|Dose proportionality for AUCτ,ss of BI 1265162 in plasma was assessed using a power model (regression model applied to log-transformed data). The corresponding ANCOVA model included the logarithm of the dose as a covariate. No statistical hypotheses were tested in a confirmatory sense.||1.1069|0.9972|
70979194|NCT03576144|141466778|OTHER||Slope|1.0361|STANDARD_ERROR_OF_MEAN|0.0379|||TWO_SIDED|90.0|0.9722|1.1001|||ANCOVA||Standard Error of the mean is actually standard error of slope. Based on the estimate for the slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|Dose proportionality for Cmax,ss of BI 1265162 in plasma was assessed using a power model (regression model applied to log-transformed data). The corresponding ANCOVA model included the logarithm of the dose as a covariate. No statistical hypotheses were tested in a confirmatory sense.||1.1001|0.9722|
70979195|NCT03263091|141466787|OTHER||Odds Ratio (OR)|1.582||||0.217|TWO_SIDED|95.0|0.761|3.29|||Cochran-Mantel-Haenszel|||The odds ratio along with its 95% confidence interval (CI) were calculated based on the Cochran-Mantel-Haenszel (CMH) chi-square test adjusting for the stratification factors (EPO level, International Prognostic Scoring System - Revised \[IPSS-R\] risk category and RBC transfusion burden).||3.290|0.761|0.217
70979196|NCT05067127|141466879|SUPERIORITY||Difference in least squares (LS) mean|-1.143|||<|0.0001|TWO_SIDED|95.0|-1.436|-0.85|||MMRM|||An mixed-effect model for repeated measures (MMRM) including fixed categorical effect for treatment group, visit, disease type, baseline immunosuppressants use, stratification factors, and the visit-by-treatment group interactions as well as the continuous, fixed covariate of baseline log-transformed uPCR, was utilized to analyze the log-transformed ratio of uPCR at Week 26 compared to baseline.||-0.85|-1.436|<0.0001
70979197|NCT05067127|141466880|SUPERIORITY||Odds Ratio (OR)|27.516|||<|0.0001|TWO_SIDED|95.0|6.105|124.026|||Logistic|||The logistic model included treatment group as independent variable and adjusted for baseline eGFR values, baseline log-transformed uPCR values, disease type, and stratification factors.||124.026|6.105|<0.0001
70979198|NCT05067127|141466881|SUPERIORITY||Odds Ratio (OR)|30.932|||<|0.0001|TWO_SIDED|95.0|8.401|113.897|||Logistic|||The logistic model included treatment group as independent variable and adjusted for baseline log-transformed uPCR values, disease type, and stratification factors.||113.897|8.401|<0.0001
70979199|NCT05067127|141466882|SUPERIORITY||Difference in LS mean|-1.002||||0.2753|TWO_SIDED|95.0|-2.803|0.798|||ANCOVA|||Analysis of covariance (ANCOVA) model included treatment as fixed effect, adjusted for baseline C3G histologic index activity score, disease type, and stratification factors.||0.798|-2.803|0.2753
71034968|NCT03100344|141579151|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.658|TWO_SIDED|95.0|-5.8|9.2|||Cochran-Mantel-Haenszel|||Week 1||9.2|-5.8|0.658
71034969|NCT03100344|141579151|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.69|TWO_SIDED|95.0|-8.0|12.2|||Cochran-Mantel-Haenszel|||Week 2||12.2|-8.0|0.690
70979200|NCT05067127|141466883|SUPERIORITY||Odds Ratio (OR)|27.392|||<|0.0001|TWO_SIDED|95.0|6.477|115.852|||Logistic|||The logistic model included treatment group as independent variable and adjusted for baseline C3c staining, disease type, and stratification factors.||115.852|6.477|<0.0001
70979201|NCT05067127|141466884|SUPERIORITY||Difference in LS mean|6.312||||0.0333|TWO_SIDED|95.0|0.501|12.122|||MMRM|||An MMRM model included fixed categorical effect for treatment group, visit, disease type, stratification factors, and the visit-by-treatment group interactions as well as the continuous, fixed covariate of baseline eGFR, was utilized to analyze the mean change from baseline to Week 26 in eGFR.||12.122|0.501|0.0333
70979202|NCT05067127|141466885|SUPERIORITY||Odds Ratio (OR)|5.753||||0.0006|TWO_SIDED|95.0|2.106|15.716|||Logistic|||The logistic model included treatment group as independent variable and adjusted for baseline proteinuria values, disease type, and stratification factors.||15.716|2.106|0.0006
70979203|NCT05067127|141466886|SUPERIORITY||Odds Ratio (OR)|88.341||||0.0001|TWO_SIDED|95.0|8.863|880.544|||Logistic|||The logistic model included treatment group as independent variable and adjusted for baseline albumin values, disease type, and stratification factors.||880.544|8.863|0.0001
70979204|NCT05067127|141466887|SUPERIORITY||Odds Ratio (OR)|999.999||||0.0094|TWO_SIDED|95.0|12.175|9999.999|||Logistic|||The logistic model included treatment group as independent variable and adjusted for baseline C3 levels, stratification factors and disease type.||9999.999|12.175|0.0094
71034970|NCT03100344|141579151|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.521|TWO_SIDED|95.0|-6.9|13.7|||Cochran-Mantel-Haenszel|||Week 2||13.7|-6.9|0.521
71034971|NCT03100344|141579151|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.033|TWO_SIDED|95.0|1.5|26.5|||Cochran-Mantel-Haenszel|||Week 2||26.5|1.5|0.033
71034972|NCT03100344|141579151|SUPERIORITY||Mean Difference (Final Values)|7.4||||0.172|TWO_SIDED|95.0|-3.1|18.0|||Cochran-Mantel-Haenszel|||Week 4||18.0|-3.1|0.172
71034973|NCT03100344|141579151|SUPERIORITY||Mean Difference (Final Values)|15.7||||0.014|TWO_SIDED|95.0|3.7|27.7|||Cochran-Mantel-Haenszel|||Week 4||27.7|3.7|0.014
71034974|NCT03100344|141579151|SUPERIORITY||Mean Difference (Final Values)|21.0||||0.002|TWO_SIDED|95.0|8.2|33.9|||Cochran-Mantel-Haenszel|||Week 4||33.9|8.2|0.002
70979205|NCT05067127|141466888|SUPERIORITY||Difference in LS mean|0.562||||0.7384|TWO_SIDED|95.0|-2.739|3.863|||ANCOVA|||The ANCOVA model included treatment as fixed effect, adjusted for baseline, disease type, and stratification factors.||3.863|-2.739|0.7384
70979206|NCT05067127|141466889|SUPERIORITY||Difference in LS mean|1.345||||0.5648|TWO_SIDED|95.0|-3.237|5.927|||ANCOVA|||The ANCOVA model included treatment as fixed effect, adjusted for baseline, disease type, and stratification factors.||5.927|-3.237|0.5648
70979207|NCT01499173|141466895|SUPERIORITY||||||<|0.01||||||Actual p value shown here; not threshold.|multilevel linear regression|||||||<0.01
70979208|NCT01499173|141466896|SUPERIORITY|||||||0.34|||||||multilevel linear regression|||||||0.34
70979209|NCT01499173|141466897|OTHER|odds ratio|Odds Ratio (OR)|-0.5|||||TWO_SIDED|||||||||Odds ratio was calculated for each question comparing 1 week data with 1 month data||||
70979210|NCT03193866|141466923|SUPERIORITY||Difference in proportion|1.5|||||TWO_SIDED|95.0|-1.8|4.9||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.9|-1.8|
70979211|NCT03193866|141466923|SUPERIORITY||Difference in proportion|-0.2|||||TWO_SIDED|95.0|-6.8|6.5||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||6.5|-6.8|
70979212|NCT03193866|141466923|SUPERIORITY||Difference in proportion|1.3|||||TWO_SIDED|95.0|-1.7|4.3||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.3|-1.7|
70979213|NCT03193866|141466923|SUPERIORITY||Difference in proportion|-0.9|||||TWO_SIDED|95.0|-4.3|2.4||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||2.4|-4.3|
70979214|NCT03193866|141466923|SUPERIORITY||Difference in proportion|1.7|||||TWO_SIDED|95.0|-1.3|4.6||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.6|-1.3|
70979215|NCT03193866|141466923|SUPERIORITY||Difference in proportion|0.3|||||TWO_SIDED|95.0|-2.7|3.3||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||3.3|-2.7|
70979216|NCT03193866|141466923|SUPERIORITY||Difference in proportion|1.2|||||TWO_SIDED|95.0|-2.0|4.4||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.4|-2.0|
71008761|NCT02055976|141525252|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-95.205|STANDARD_ERROR_OF_MEAN|5.556|<|0.001|TWO_SIDED|95.0|-106.238|-84.172|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-84.172|-106.238|<0.001
71008762|NCT02055976|141525252|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-106.077|STANDARD_ERROR_OF_MEAN|5.622|<|0.001|TWO_SIDED|95.0|-117.239|-94.915|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-94.915|-117.239|<0.001
71008763|NCT02055976|141525252|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-71.234|STANDARD_ERROR_OF_MEAN|6.622|<|0.001|TWO_SIDED|95.0|-84.39|-58.077|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-58.077|-84.390|<0.001
71008764|NCT02055976|141525252|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-100.638|STANDARD_ERROR_OF_MEAN|6.609|<|0.001|TWO_SIDED|95.0|-113.768|-87.508|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-87.508|-113.768|<0.001
70979217|NCT03193866|141466923|SUPERIORITY||Difference in proportion|2.0|||||TWO_SIDED|95.0|-3.2|7.1||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||7.1|-3.2|
70979218|NCT03193866|141466924|SUPERIORITY||Difference in proportion|0.7|||||TWO_SIDED|95.0|-7.5|8.8||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||8.8|-7.5|
70979219|NCT03193866|141466924|SUPERIORITY||Difference in proportion|-2.9|||||TWO_SIDED|95.0|-18.5|12.8||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||12.8|-18.5|
70979220|NCT03193866|141466924|SUPERIORITY||Difference in proportion|-0.1|||||TWO_SIDED|95.0|-8.8|8.6||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||8.6|-8.8|
70979221|NCT03193866|141466924|SUPERIORITY||Difference in proportion|-0.5|||||TWO_SIDED|95.0|-8.1|7.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||7.2|-8.1|
70979222|NCT03193866|141466924|SUPERIORITY||Difference in proportion|1.6|||||TWO_SIDED|95.0|-5.7|8.9||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||8.9|-5.7|
70979223|NCT03193866|141466924|SUPERIORITY||Difference in proportion|1.6|||||TWO_SIDED|95.0|-4.7|8.0||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||8.0|-4.7|
70979224|NCT03193866|141466924|SUPERIORITY||Difference in proportion|0.9|||||TWO_SIDED|95.0|-6.2|7.9||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||7.9|-6.2|
70979225|NCT03193866|141466924|SUPERIORITY||Difference in proportion|-1.6|||||TWO_SIDED|95.0|-10.8|7.5||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||7.5|-10.8|
71034975|NCT03100344|141579151|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.404|TWO_SIDED|95.0|-7.5|18.8|||Cochran-Mantel-Haenszel|||Week 8||18.8|-7.5|0.404
71034976|NCT03100344|141579151|SUPERIORITY||Mean Difference (Final Values)|24.5||||0.003|TWO_SIDED|95.0|9.4|39.6|||Cochran-Mantel-Haenszel|||Week 8||39.6|9.4|0.003
71096307|NCT04053452|141701467|OTHER|Vagus|Kendall's tau correlation coefficient|0.0246|||||TWO_SIDED|95.0|-0.3506|0.4596||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.4596|-0.3506|
71034977|NCT03100344|141579151|SUPERIORITY||Mean Difference (Final Values)|14.1||||0.059|TWO_SIDED|95.0|-0.1|28.2|||Cochran-Mantel-Haenszel|||Week 8||28.2|-0.1|0.059
71034978|NCT03100344|141579151|SUPERIORITY||Mean Difference (Final Values)|9.7||||0.222|TWO_SIDED|95.0|-5.6|25.0|||Cochran-Mantel-Haenszel|||Week 12||25.0|-5.6|0.222
71034979|NCT03100344|141579151|SUPERIORITY||Mean Difference (Final Values)|26.1||||0.003|TWO_SIDED|95.0|10.0|42.3|||Cochran-Mantel-Haenszel|||Week 12||42.3|10.0|0.003
71034980|NCT03100344|141579151|SUPERIORITY||Mean Difference (Final Values)|19.1||||0.22|TWO_SIDED|95.0|3.3|35.0|||Cochran-Mantel-Haenszel|||Week 12||35.0|3.3|0.22
71034981|NCT03100344|141579151|SUPERIORITY||Mean Difference (Final Values)|13.3||||0.111|TWO_SIDED|95.0|-2.8|29.3|||Cochran-Mantel-Haenszel|||Week 16||29.3|-2.8|0.111
71034982|NCT03100344|141579151|SUPERIORITY||Mean Difference (Final Values)|29.6|||<|0.001|TWO_SIDED|95.0|13.2|46.0|||Cochran-Mantel-Haenszel|||Week 16||46.0|13.2|<0.001
71096308|NCT04053452|141701468|OTHER|Median at wrist|Odds Ratio (OR)|0.7686494||||0.36|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.360
71034983|NCT03100344|141579151|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.04|TWO_SIDED|95.0|1.3|33.6|||Cochran-Mantel-Haenszel|||Week 16||33.6|1.3|0.040
71034984|NCT03100344|141579151|SUPERIORITY||Mean Difference (Final Values)|10.1||||0.262|TWO_SIDED|95.0|-7.3|27.4|||Cochran-Mantel-Haenszel|||Week 20||27.4|-7.3|0.262
71034985|NCT03100344|141579151|SUPERIORITY||Mean Difference (Final Values)|8.7||||0.327|TWO_SIDED|95.0|-8.4|25.7|||Cochran-Mantel-Haenszel|||Week 20||25.7|-8.4|0.327
71034986|NCT03100344|141579151|SUPERIORITY||Mean Difference (Final Values)|15.7||||0.083|TWO_SIDED|95.0|-1.7|33.1|||Cochran-Mantel-Haenszel|||Week 20||33.1|-1.7|0.083
71034987|NCT03100344|141579151|SUPERIORITY||Mean Difference (Final Values)|10.1||||0.255|TWO_SIDED|95.0|-7.0|27.2|||Cochran-Mantel-Haenszel|||Week 24||27.2|-7.0|0.255
71034988|NCT03100344|141579151|SUPERIORITY||Mean Difference (Final Values)|19.0||||0.034|TWO_SIDED|95.0|2.2|35.9|||Cochran-Mantel-Haenszel|||Week 24||35.9|2.2|0.034
71034989|NCT03100344|141579151|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.053|TWO_SIDED|95.0|0.3|34.6|||Cochran-Mantel-Haenszel|||Week 24||34.6|0.3|0.053
71034990|NCT03100344|141579152|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.97|TWO_SIDED|95.0|-4.9|5.1|||Cochran-Mantel-Haenszel|||Week 1||5.1|-4.9|0.970
71034991|NCT03100344|141579152|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.574|TWO_SIDED|95.0|-4.1|7.5|||Cochran-Mantel-Haenszel|||Week 1||7.5|-4.1|0.574
71034992|NCT03100344|141579152|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.985|TWO_SIDED|95.0|-4.8|4.8|||Cochran-Mantel-Haenszel|||Week 1||4.8|-4.8|0.985
71034993|NCT03100344|141579152|SUPERIORITY||Mean Difference (Final Values)|-3.6||||0.154|TWO_SIDED|95.0|-8.4|1.2|||Cochran-Mantel-Haenszel|||Week 2||1.2|-8.4|0.154
71034994|NCT03100344|141579152|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.978|TWO_SIDED|95.0|-6.8|6.6|||Cochran-Mantel-Haenszel|||Week 2||6.6|-6.8|0.978
71034995|NCT03100344|141579152|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.978|TWO_SIDED|95.0|-6.8|6.6|||Cochran-Mantel-Haenszel|||Week 2||6.6|-6.8|0.978
71034996|NCT03100344|141579152|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.602|TWO_SIDED|95.0|-7.5|4.3|||Cochran-Mantel-Haenszel|||Week 4||4.3|-7.5|0.602
71034997|NCT03100344|141579152|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.413|TWO_SIDED|95.0|-4.5|11.4|||Cochran-Mantel-Haenszel|||Week 4||11.4|-4.5|0.413
71034998|NCT03100344|141579152|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.658|TWO_SIDED|95.0|-5.7|9.1|||Cochran-Mantel-Haenszel|||Week 4||9.1|-5.7|0.658
71034999|NCT03100344|141579152|SUPERIORITY||Mean Difference (Final Values)|3.6||||0.307|TWO_SIDED|95.0|-3.2|10.3|||Cochran-Mantel-Haenszel|||Week 8||10.3|-3.2|0.307
71035000|NCT03100344|141579152|SUPERIORITY||Mean Difference (Final Values)|17.3||||0.002|TWO_SIDED|95.0|6.9|27.8|||Cochran-Mantel-Haenszel|||Week 8||27.8|6.9|0.002
71035001|NCT03100344|141579152|SUPERIORITY||Mean Difference (Final Values)|8.7||||0.054|TWO_SIDED|95.0|0.1|17.4|||Cochran-Mantel-Haenszel|||Week 8||17.4|0.1|0.054
71035002|NCT03100344|141579152|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.325|TWO_SIDED|95.0|-5.4|16.5|||Cochran-Mantel-Haenszel|||Week 12||16.5|-5.4|0.325
71035003|NCT03100344|141579152|SUPERIORITY||Mean Difference (Final Values)|15.6||||0.019|TWO_SIDED|95.0|3.1|28.1|||Cochran-Mantel-Haenszel|||Week 12||28.1|3.1|0.019
71035004|NCT03100344|141579152|SUPERIORITY||Mean Difference (Final Values)|17.5||||0.011|TWO_SIDED|95.0|4.5|30.5|||Cochran-Mantel-Haenszel|||Week 12||30.5|4.5|0.011
71035005|NCT03100344|141579152|SUPERIORITY||Mean Difference (Final Values)|9.2||||0.153|TWO_SIDED|95.0|-3.2|21.7|||Cochran-Mantel-Haenszel|||Week 16||21.7|-3.2|0.153
71035006|NCT03100344|141579152|SUPERIORITY||Mean Difference (Final Values)|24.4||||0.001|TWO_SIDED|95.0|10.3|38.4|||Cochran-Mantel-Haenszel|||Week 16||38.4|10.3|0.001
71035007|NCT03100344|141579152|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.069|TWO_SIDED|95.0|-0.7|25.1|||Cochran-Mantel-Haenszel|||Week 16||25.1|-0.7|0.069
71035008|NCT03100344|141579152|SUPERIORITY||Mean Difference (Final Values)|12.9||||0.07|TWO_SIDED|95.0|-0.8|26.6|||Cochran-Mantel-Haenszel|||Week 20||26.6|-0.8|0.070
71035009|NCT03100344|141579152|SUPERIORITY||Mean Difference (Final Values)|20.9||||0.006|TWO_SIDED|95.0|6.5|35.3|||Cochran-Mantel-Haenszel|||Week 20||35.3|6.5|0.006
71035010|NCT03100344|141579152|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.052|TWO_SIDED|95.0|0.3|27.7|||Cochran-Mantel-Haenszel|||Week 20||27.7|0.3|0.052
71035011|NCT03100344|141579152|SUPERIORITY||Mean Difference (Final Values)|12.8||||0.069|TWO_SIDED|95.0|-0.7|26.3|||Cochran-Mantel-Haenszel|||Week 24||26.3|-0.7|0.069
71035012|NCT03100344|141579152|SUPERIORITY||Mean Difference (Final Values)|19.1||||0.011|TWO_SIDED|95.0|4.9|33.3|||Cochran-Mantel-Haenszel|||Week 24||33.3|4.9|0.011
71035013|NCT03100344|141579152|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.083|TWO_SIDED|95.0|-1.3|25.7|||Cochran-Mantel-Haenszel|||Week 24||25.7|-1.3|0.083
71035014|NCT03100344|141579153|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.97|TWO_SIDED|95.0|-4.9|5.1|||Cochran-Mantel-Haenszel|||Week 1||5.1|-4.9|0.970
71035015|NCT03100344|141579153|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.574|TWO_SIDED|95.0|-4.1|7.5|||Cochran-Mantel-Haenszel|||Week 1||7.5|-4.1|0.574
71035016|NCT03100344|141579153|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.311|TWO_SIDED|95.0|-5.2|1.7|||Cochran-Mantel-Haenszel|||Week 1||1.7|-5.2|0.311
71035017|NCT03100344|141579153|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.558|TWO_SIDED|95.0|-7.7|4.1|||Cochran-Mantel-Haenszel|||Week 2||4.1|-7.7|0.558
71035018|NCT03100344|141579153|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.413|TWO_SIDED|95.0|-4.7|11.6|||Cochran-Mantel-Haenszel|||Week 2||11.6|-4.7|0.413
71035019|NCT03100344|141579153|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.543|TWO_SIDED|95.0|-7.7|4.0|||Cochran-Mantel-Haenszel|||Week 2||4.0|-7.7|0.543
71035020|NCT03100344|141579153|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.583|TWO_SIDED|95.0|-7.6|4.2|||Cochran-Mantel-Haenszel|||Week 4||4.2|-7.6|0.583
70979226|NCT03193866|141466925|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-2.5|3.3||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||3.3|-2.5|
70979227|NCT03193866|141466925|SUPERIORITY||Mean Difference (Net)|-4.5|||||TWO_SIDED|95.0|-12.5|3.4||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||3.4|-12.5|
70979228|NCT03193866|141466925|SUPERIORITY||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-2.5|1.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.8|-2.5|
70979229|NCT03193866|141466925|SUPERIORITY||Mean Difference (Net)|-2.5|||||TWO_SIDED|95.0|-4.9|-0.1||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-0.1|-4.9|
70979230|NCT03193866|141466925|SUPERIORITY||Mean Difference (Net)|-0.7|||||TWO_SIDED|95.0|-2.6|1.1||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.1|-2.6|
70979231|NCT03193866|141466925|SUPERIORITY||Mean Difference (Net)|-1.9|||||TWO_SIDED|95.0|-4.2|0.3||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.3|-4.2|
70979232|NCT03193866|141466925|SUPERIORITY||Mean Difference (Net)|-1.8|||||TWO_SIDED|95.0|-4.0|0.3||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.3|-4.0|
70979233|NCT03193866|141466925|SUPERIORITY||Mean Difference (Net)|2.6|||||TWO_SIDED|95.0|-0.6|5.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||5.8|-0.6|
70979234|NCT03193866|141466926|SUPERIORITY||Mean Difference (Net)|2.3|||||TWO_SIDED|95.0|-2.2|6.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||6.8|-2.2|
70979235|NCT03193866|141466926|SUPERIORITY||Mean Difference (Net)|-8.3|||||TWO_SIDED|95.0|-20.3|3.7||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||3.7|-20.3|
70979236|NCT03193866|141466926|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-2.6|3.5||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||3.5|-2.6|
70979237|NCT03193866|141466926|SUPERIORITY||Mean Difference (Net)|-2.4|||||TWO_SIDED|95.0|-5.8|0.9||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.9|-5.8|
71035021|NCT03100344|141579153|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.028|TWO_SIDED|95.0|1.8|22.5|||Cochran-Mantel-Haenszel|||Week 4||22.5|1.8|0.028
71035022|NCT03100344|141579153|SUPERIORITY||Mean Difference (Final Values)|8.7||||0.087|TWO_SIDED|95.0|-0.9|18.3|||Cochran-Mantel-Haenszel|||Week 4||18.3|-0.9|0.087
70979238|NCT03193866|141466926|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-2.9|2.7||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||2.7|-2.9|
70979239|NCT03193866|141466926|SUPERIORITY||Mean Difference (Net)|-1.5|||||TWO_SIDED|95.0|-4.5|1.6||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.6|-4.5|
70979240|NCT03193866|141466926|SUPERIORITY||Mean Difference (Net)|-1.6|||||TWO_SIDED|95.0|-4.7|1.5||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.5|-4.7|
70979241|NCT03193866|141466926|SUPERIORITY||Mean Difference (Net)|2.3|||||TWO_SIDED|95.0|-1.7|6.4||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||6.4|-1.7|
70979242|NCT03193866|141466927|SUPERIORITY||Difference in proportion|0.39|||||TWO_SIDED|95.0|0.3|0.48||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.48|0.30|
70979243|NCT03193866|141466927|SUPERIORITY||Difference in proportion|0.27|||||TWO_SIDED|95.0|0.11|0.42||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.42|0.11|
70979244|NCT03193866|141466927|SUPERIORITY||Difference in proportion|0.17|||||TWO_SIDED|95.0|0.1|0.23||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.23|0.10|
70979245|NCT03193866|141466927|SUPERIORITY||Difference in proportion|0.05|||||TWO_SIDED|95.0|-0.03|0.13||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.13|-0.03|
70979246|NCT03193866|141466927|SUPERIORITY||Difference in proportion|0.14|||||TWO_SIDED|95.0|0.08|0.19||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.19|0.08|
70979247|NCT03193866|141466927|SUPERIORITY||Difference in proportion|0.09|||||TWO_SIDED|95.0|0.01|0.16||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.16|0.01|
70979248|NCT03193866|141466927|SUPERIORITY||Difference in proportion|0.14|||||TWO_SIDED|95.0|0.06|0.21||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.21|0.06|
70979249|NCT03193866|141466927|SUPERIORITY||Difference in proportion|0.23|||||TWO_SIDED|95.0|0.13|0.33||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.33|0.13|
71035023|NCT03100344|141579153|SUPERIORITY||Mean Difference (Final Values)|1.9||||0.632|TWO_SIDED|95.0|-5.6|9.4|||Cochran-Mantel-Haenszel|||Week 8||9.4|-5.6|0.632
71035024|NCT03100344|141579153|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.016|TWO_SIDED|95.0|3.1|24.8|||Cochran-Mantel-Haenszel|||Week 8||24.8|3.1|0.016
70979250|NCT03193866|141466928|SUPERIORITY||Difference in proportion|-71.6|||||TWO_SIDED|95.0|-76.6|-66.6||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-66.6|-76.6|
70979251|NCT03193866|141466928|SUPERIORITY||Difference in proportion|-66.3|||||TWO_SIDED|95.0|-76.3|-56.4||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-56.4|-76.3|
70979252|NCT03193866|141466928|SUPERIORITY||Difference in proportion|-47.3|||||TWO_SIDED|95.0|-53.0|-41.7||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-41.7|-53.0|
71035025|NCT03100344|141579153|SUPERIORITY||Mean Difference (Final Values)|15.8||||0.009|TWO_SIDED|95.0|4.5|27.0|||Cochran-Mantel-Haenszel|||Week 8||27.0|4.5|0.009
71035026|NCT03100344|141579153|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.974|TWO_SIDED|95.0|-11.2|11.6|||Cochran-Mantel-Haenszel|||Week 12||11.6|-11.2|0.974
71035027|NCT03100344|141579153|SUPERIORITY||Mean Difference (Final Values)|15.6||||0.031|TWO_SIDED|95.0|1.8|29.3|||Cochran-Mantel-Haenszel|||Week 12||29.3|1.8|0.031
71035028|NCT03100344|141579153|SUPERIORITY||Mean Difference (Final Values)|15.6||||0.032|TWO_SIDED|95.0|1.8|29.5|||Cochran-Mantel-Haenszel|||Week 12||29.5|1.8|0.032
71035029|NCT03100344|141579153|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.553|TWO_SIDED|95.0|-9.0|16.9|||Cochran-Mantel-Haenszel|||Week 16||16.9|-9.0|0.553
71096309|NCT04053452|141701468|OTHER|Median at forearm|Odds Ratio (OR)|0.9315228||||0.521|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.521
70979253|NCT03193866|141466928|SUPERIORITY||Difference in proportion|-43.1|||||TWO_SIDED|95.0|-49.6|-36.6||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-36.6|-49.6|
70979254|NCT03193866|141466928|SUPERIORITY||Difference in proportion|-41.3|||||TWO_SIDED|95.0|-46.4|-36.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-36.2|-46.4|
70979255|NCT03193866|141466928|SUPERIORITY||Difference in proportion|-33.9|||||TWO_SIDED|95.0|-39.8|-28.0||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-28.0|-39.8|
71035030|NCT03100344|141579153|SUPERIORITY||Mean Difference (Final Values)|20.9||||0.008|TWO_SIDED|95.0|6.1|35.8|||Cochran-Mantel-Haenszel|||Week 16||35.8|6.1|0.008
71035031|NCT03100344|141579153|SUPERIORITY||Mean Difference (Final Values)|13.9||||0.061|TWO_SIDED|95.0|-0.3|28.2|||Cochran-Mantel-Haenszel|||Week 16||28.2|-0.3|0.061
71035032|NCT03100344|141579153|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.585|TWO_SIDED|95.0|-10.1|18.0|||Cochran-Mantel-Haenszel|||Week 20||18.0|-10.1|0.585
71035033|NCT03100344|141579153|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.032|TWO_SIDED|95.0|2.0|32.8|||Cochran-Mantel-Haenszel|||Week 20||32.8|2.0|0.032
71035034|NCT03100344|141579153|SUPERIORITY||Mean Difference (Final Values)|8.6||||0.254|TWO_SIDED|95.0|-5.9|23.1|||Cochran-Mantel-Haenszel|||Week 20||23.1|-5.9|0.254
71035035|NCT03100344|141579153|SUPERIORITY||Mean Difference (Final Values)|4.2||||0.598|TWO_SIDED|95.0|-11.3|19.8|||Cochran-Mantel-Haenszel|||Week 24||19.8|-11.3|0.598
71035036|NCT03100344|141579153|SUPERIORITY||Mean Difference (Final Values)|15.5||||0.066|TWO_SIDED|95.0|-0.4|31.4|||Cochran-Mantel-Haenszel|||Week 24||31.4|-0.4|0.066
71035037|NCT03100344|141579153|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.826|TWO_SIDED|95.0|-13.5|16.9|||Cochran-Mantel-Haenszel|||Week 24||16.9|-13.5|0.826
71035038|NCT03100344|141579154|SUPERIORITY||mean difference of percentage changes|-10.0||||0.049|TWO_SIDED|95.0|-20.0|0.0|||Kenward-Rogers|||Week 1||0.0|-20.0|0.049
71035039|NCT03100344|141579154|SUPERIORITY||mean difference of percentage changes|-16.9|||<|0.001|TWO_SIDED|95.0|-26.7|-7.0|||Kenward Roger|||Week 1||-7.0|-26.7|<0.001
71035040|NCT03100344|141579154|SUPERIORITY||mean difference of percentage changes|-15.7||||0.002|TWO_SIDED|95.0|-25.6|-5.8|||Kenward Roger|||Week 1||-5.8|-25.6|0.002
71096310|NCT04053452|141701468|OTHER|Median at cubital fossa|Odds Ratio (OR)|0.7949528||||0.245|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.245
70979256|NCT03193866|141466928|SUPERIORITY||Difference in proportion|-33.9|||||TWO_SIDED|95.0|-39.7|-28.0||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-28.0|-39.7|
70979257|NCT03193866|141466928|SUPERIORITY||Difference in proportion|-49.8|||||TWO_SIDED|95.0|-58.0|-41.6||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-41.6|-58.0|
70979258|NCT03193866|141466929|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.1|0.3||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.3|-0.1|
70979259|NCT03193866|141466929|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.3|0.4||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.4|-0.3|
70979260|NCT03193866|141466929|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.2|0.1||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.1|-0.2|
70979261|NCT03193866|141466929|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.3|0.1||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.1|-0.3|
70979262|NCT03193866|141466929|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.1|-0.1|
70979263|NCT03193866|141466929|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.2|0.1||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.1|-0.2|
70979264|NCT03193866|141466929|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.1|0.2||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.2|-0.1|
70979265|NCT03193866|141466929|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.1|0.3||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.3|-0.1|
70979266|NCT03193866|141466930|SUPERIORITY||Difference in proportion|4.8|||||TWO_SIDED|95.0|-2.2|11.9||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||11.9|-2.2|
70979267|NCT03193866|141466930|SUPERIORITY||Difference in proportion|9.0|||||TWO_SIDED|95.0|-2.6|20.6||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||20.6|-2.6|
71035041|NCT03100344|141579154|SUPERIORITY||mean difference of percentage changes|-9.8||||0.084|TWO_SIDED|95.0|-20.9|1.3|||Kenward Roger|||Week 2||1.3|-20.9|0.084
71096311|NCT04053452|141701468|OTHER|Median at humerus|Odds Ratio (OR)|0.8603349||||0.541|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.541
71096312|NCT04053452|141701468|OTHER|Median at axilla|Odds Ratio (OR)|0.8767973||||0.415|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.415
70979268|NCT03193866|141466930|SUPERIORITY||Difference in proportion|-0.7|||||TWO_SIDED|95.0|-7.6|6.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||6.2|-7.6|
70979269|NCT03193866|141466930|SUPERIORITY||Difference in proportion|-2.6|||||TWO_SIDED|95.0|-9.4|4.1||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.1|-9.4|
70979270|NCT03193866|141466930|SUPERIORITY||Difference in proportion|-2.6|||||TWO_SIDED|95.0|-8.6|3.4||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||3.4|-8.6|
70979271|NCT03193866|141466930|SUPERIORITY||Difference in proportion|3.8|||||TWO_SIDED|95.0|-4.7|12.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||12.2|-4.7|
70979272|NCT03193866|141466930|SUPERIORITY||Difference in proportion|0.6|||||TWO_SIDED|95.0|-6.9|8.1||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||8.1|-6.9|
70979273|NCT03193866|141466930|SUPERIORITY||Difference in proportion|3.9|||||TWO_SIDED|95.0|-6.3|14.1||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||14.1|-6.3|
70979274|NCT03193866|141466931|SUPERIORITY||Difference in proportion|-34.1|||||TWO_SIDED|95.0|-40.3|-27.9||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-27.9|-40.3|
71035042|NCT03100344|141579154|SUPERIORITY||mean difference of percentage changes|-16.2||||0.004|TWO_SIDED|95.0|-27.2|-5.2|||Kenward Roger|||Week 2||-5.2|-27.2|0.004
71035043|NCT03100344|141579154|SUPERIORITY||mean difference of percentage changes|-14.8||||0.008|TWO_SIDED|95.0|-25.8|-3.8|||Kenward Roger|||Week 2||-3.8|-25.8|0.008
71096313|NCT04053452|141701468|OTHER|Ulnar at wrist|Odds Ratio, log|0.7613965||||0.504|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.504
71096314|NCT04053452|141701468|OTHER|Ulnar at forearm|Odds Ratio (OR)|0.8061505||||0.393|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.393
71096315|NCT04053452|141701468|OTHER|Ulnar at cubital fossa|Odds Ratio (OR)|0.8336885||||0.222|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.222
71096316|NCT04053452|141701468|OTHER|Ulnar at humerus|Odds Ratio (OR)|1.1214848||||0.615|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.615
71096317|NCT04053452|141701468|OTHER|Ulnar at axilla|Odds Ratio (OR)|0.9898411||||0.926|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.926
71096318|NCT04053452|141701468|OTHER|C6|Odds Ratio (OR)|0.9402829||||0.519|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.519
71035044|NCT03100344|141579154|SUPERIORITY||mean difference of percentage changes|-14.0||||0.044|TWO_SIDED|95.0|-27.5|-0.4|||Kenward Roger|||Week 4||-0.4|-27.5|0.044
71035045|NCT03100344|141579154|SUPERIORITY||mean difference of percentage changes|-21.1||||0.002|TWO_SIDED|95.0|-34.7|-7.6|||Kenward Roger|||Week 4||-7.6|-34.7|0.002
70979275|NCT03193866|141466931|SUPERIORITY||Difference in proportion|-32.2|||||TWO_SIDED|95.0|-43.0|-21.5||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-21.5|-43.0|
70979276|NCT03193866|141466931|SUPERIORITY||Difference in proportion|-21.8|||||TWO_SIDED|95.0|-27.9|-15.7||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-15.7|-27.9|
70979277|NCT03193866|141466931|SUPERIORITY||Difference in proportion|-7.8|||||TWO_SIDED|95.0|-14.5|-1.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-1.2|-14.5|
70979278|NCT03193866|141466931|SUPERIORITY||Difference in proportion|-23.6|||||TWO_SIDED|95.0|-28.9|-18.3||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-18.3|-28.9|
70979279|NCT03193866|141466931|SUPERIORITY||Difference in proportion|-12.7|||||TWO_SIDED|95.0|-18.9|-6.5||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-6.5|-18.9|
70979280|NCT03193866|141466931|SUPERIORITY||Difference in proportion|-26.5|||||TWO_SIDED|95.0|-32.8|-20.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-20.2|-32.8|
70979281|NCT03193866|141466931|SUPERIORITY||Difference in proportion|-31.7|||||TWO_SIDED|95.0|-40.1|-23.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-23.2|-40.1|
70979282|NCT03193866|141466932|SUPERIORITY||Difference in proportion|-33.2|||||TWO_SIDED|95.0|-39.4|-27.0||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-27.0|-39.4|
70979283|NCT03193866|141466932|SUPERIORITY||Difference in proportion|-30.6|||||TWO_SIDED|95.0|-41.4|-19.8||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-19.8|-41.4|
71035046|NCT03100344|141579154|SUPERIORITY||mean difference of percentage changes|-15.3||||0.026|TWO_SIDED|95.0|-28.8|-1.8|||Kenward Roger|||Week 4||-1.8|-28.8|0.026
71035047|NCT03100344|141579154|SUPERIORITY||mean difference of percentage changes|-14.8||||0.062|TWO_SIDED|95.0|-30.2|0.7|||Kenward Roger|||Week 8||0.7|-30.2|0.062
71035048|NCT03100344|141579154|SUPERIORITY||mean difference of percentage changes|-23.4||||0.003|TWO_SIDED|95.0|-38.9|-7.9|||Kenward Roger|||Week 8||-7.9|-38.9|0.003
71035049|NCT03100344|141579154|SUPERIORITY||mean difference of percentage changes|-20.6||||0.009|TWO_SIDED|95.0|-36.0|-5.2|||Kenward Roger|||Week 8||-5.2|-36.0|0.009
71035050|NCT03100344|141579154|SUPERIORITY||mean difference of percentage changes|-15.9||||0.022|TWO_SIDED|95.0|-29.4|-2.3|||Kenward Roger|||Week 12||-2.3|-29.4|0.022
71035051|NCT03100344|141579154|SUPERIORITY||mean difference of percentage changes|-23.7|||<|0.001|TWO_SIDED|95.0|-37.1|-10.2|||Kenward Roger|||Week 12||-10.2|-37.1|<0.001
71035052|NCT03100344|141579154|SUPERIORITY||mean difference of percentage changes|-14.7||||0.032|TWO_SIDED|95.0|-28.1|-1.3|||Kenward Roger|||Week 12||-1.3|-28.1|0.032
71035053|NCT03100344|141579154|SUPERIORITY||mean difference of percentage changes|-13.7||||0.07|TWO_SIDED|95.0|-28.6|1.1|||Kenward Roger|||Week 16||1.1|-28.6|0.070
71035054|NCT03100344|141579154|SUPERIORITY||mean difference of percentage changes|-23.7||||0.002|TWO_SIDED|95.0|-38.5|-8.9|||Kenward Roger|||Week 16||-8.9|-38.5|0.002
71035055|NCT03100344|141579154|SUPERIORITY||mean difference of percentage changes|-10.7||||0.154|TWO_SIDED|95.0|-25.6|4.1|||Kenward Roger|||Week 16||4.1|-25.6|0.154
71035056|NCT03100344|141579154|SUPERIORITY||mean difference of percentage changes|-12.1||||0.09|TWO_SIDED|95.0|-26.0|1.9|||Kenward Roger|||Week 20||1.9|-26.0|0.090
70979284|NCT03193866|141466932|SUPERIORITY||Difference in proportion|-20.8|||||TWO_SIDED|95.0|-27.0|-14.7||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-14.7|-27.0|
70979285|NCT03193866|141466932|SUPERIORITY||Difference in proportion|-7.0|||||TWO_SIDED|95.0|-13.6|-0.3||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-0.3|-13.6|
70979286|NCT03193866|141466932|SUPERIORITY||Difference in proportion|-23.7|||||TWO_SIDED|95.0|-29.2|-18.3||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-18.3|-29.2|
70979287|NCT03193866|141466932|SUPERIORITY||Difference in proportion|-12.3|||||TWO_SIDED|95.0|-18.6|-6.1||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-6.1|-18.6|
70979288|NCT03193866|141466932|SUPERIORITY||Difference in proportion|-25.3|||||TWO_SIDED|95.0|-31.7|-19.0||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-19.0|-31.7|
70979289|NCT03193866|141466932|SUPERIORITY||Difference in proportion|-29.5|||||TWO_SIDED|95.0|-38.2|-20.8||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-20.8|-38.2|
70979290|NCT03193866|141466933|SUPERIORITY||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.07|0.0||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.00|-0.07|
70979291|NCT03193866|141466933|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.09|0.06||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.06|-0.09|
70979292|NCT03193866|141466933|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.03|0.03||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.03|-0.03|
70979293|NCT03193866|141466933|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.03|0.05||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.05|-0.03|
70979294|NCT03193866|141466933|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.02|0.04||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.04|-0.02|
70979295|NCT03193866|141466933|SUPERIORITY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-0.01|0.06||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.06|-0.01|
71035057|NCT03100344|141579154|SUPERIORITY||mean difference of percentage changes|-15.9||||0.024|TWO_SIDED|95.0|-29.7|-2.1|||Kenward Roger|||Week 20||-2.1|-29.7|0.024
71035058|NCT03100344|141579154|SUPERIORITY||mean difference of percentage changes|-9.5||||0.18|TWO_SIDED|95.0|-23.4|4.4|||Kenward Roger|||Week 20||4.4|-23.4|0.180
71035059|NCT03100344|141579154|SUPERIORITY||mean difference of percentage changes|-13.6||||0.051|TWO_SIDED|95.0|-27.3|0.0|||Kenward Roger|||Week 24||0.0|-27.3|0.051
71035060|NCT03100344|141579154|SUPERIORITY||mean difference of percentage changes|-16.7||||0.016|TWO_SIDED|95.0|-30.2|-3.2|||Kenward Roger|||Week 24||-3.2|-30.2|0.016
71035061|NCT03100344|141579154|SUPERIORITY||mean difference of percentage changes|-6.8||||0.322|TWO_SIDED|95.0|-20.5|6.8|||Kenward Roger|||Week 24||6.8|-20.5|0.322
71035062|NCT03100344|141579155|SUPERIORITY||mean difference of percentage changes|-10.9||||0.012|TWO_SIDED|95.0|-19.4|-2.4|||Kenward Roger|||Week 1||-2.4|-19.4|0.012
70979296|NCT03193866|141466933|SUPERIORITY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|0.0|0.06||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.06|0.00|
70979297|NCT03193866|141466933|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.06|0.03||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.03|-0.06|
70979298|NCT03193866|141466934|SUPERIORITY||Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0|-3.3|5.2||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||5.2|-3.3|
70979299|NCT03193866|141466934|SUPERIORITY||Mean Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-9.4|6.4||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||6.4|-9.4|
70979300|NCT03193866|141466934|SUPERIORITY||Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-4.2|1.4||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.4|-4.2|
71035063|NCT03100344|141579155|SUPERIORITY||mean difference of percentage changes|-15.4|||<|0.001|TWO_SIDED|95.0|-23.8|-7.1|||Kenward Roger|||Week 1||-7.1|-23.8|<0.001
71035064|NCT03100344|141579155|SUPERIORITY||mean difference of percentage changes|-9.4||||0.029|TWO_SIDED|95.0|-17.8|-0.9|||Kenward Roger|||Week 1||-0.9|-17.8|0.029
71096319|NCT04053452|141701468|OTHER|C7|Odds Ratio (OR)|0.9347906||||0.379|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.379
71035065|NCT03100344|141579155|SUPERIORITY||mean difference of percentage changes|-21.8|||<|0.001|TWO_SIDED|95.0|-32.0|-11.6|||Kenward Roger|||Week 2||-11.6|-32.0|<0.001
71035066|NCT03100344|141579155|SUPERIORITY||mean difference of percentage changes|-29.1|||<|0.001|TWO_SIDED|95.0|-39.1|-19.1|||Kenward Roger|||Week 2||-19.1|-39.1|<0.001
71035067|NCT03100344|141579155|SUPERIORITY||mean difference of percentage changes|-23.8|||<|0.001|TWO_SIDED|95.0|-34.0|-13.6|||Kenward Roger|||Week 2||-13.6|-34.0|<0.001
71035068|NCT03100344|141579155|SUPERIORITY||mean difference of percentage changes|-21.3|||<|0.001|TWO_SIDED|95.0|-32.1|-10.5|||Kenward Roger|||Week 4||-10.5|-32.1|<0.001
71035069|NCT03100344|141579155|SUPERIORITY||mean difference of percentage changes|-34.8|||<|0.001|TWO_SIDED|95.0|-45.5|-24.2|||Kenward Roger|||Week 4||-24.2|-45.5|<0.001
71035070|NCT03100344|141579155|SUPERIORITY||mean difference of percentage changes|-30.7|||<|0.001|TWO_SIDED|95.0|-41.6|-19.9|||Kenward Roger|||Week 4||-19.9|-41.6|<0.001
71035071|NCT03100344|141579155|SUPERIORITY||mean difference of percentage changes|-22.9|||<|0.001|TWO_SIDED|95.0|-33.2|-12.6|||Kenward Roger|||Week 8||-12.6|-33.2|<0.001
71035072|NCT03100344|141579155|SUPERIORITY||mean difference of percentage changes|-37.3|||<|0.001|TWO_SIDED|95.0|-47.4|-27.2|||Kenward Roger|||Week 8||-27.2|-47.4|<0.001
71035073|NCT03100344|141579155|SUPERIORITY||mean difference of percentage changes|-34.1|||<|0.001|TWO_SIDED|95.0|-44.4|-23.8|||Kenward Roger|||Week 8||-23.8|-44.4|<0.001
71035074|NCT03100344|141579155|SUPERIORITY||mean difference of percentage changes|-24.1|||<|0.001|TWO_SIDED|95.0|-35.6|-12.5|||Kenward Roger|||Week 12||-12.5|-35.6|<0.001
71035075|NCT03100344|141579155|SUPERIORITY||mean difference of percentage changes|-38.4|||<|0.001|TWO_SIDED|95.0|-49.7|-27.2|||Kenward Roger|||Week 12||-27.2|-49.7|<0.001
71035076|NCT03100344|141579155|SUPERIORITY||mean difference of percentage changes|-30.2|||<|0.001|TWO_SIDED|95.0|-41.7|-18.7|||Kenward Roger|||Week 12||-18.7|-41.7|<0.001
71035077|NCT03100344|141579155|SUPERIORITY||mean difference of percentage changes|-20.9|||<|0.001|TWO_SIDED|95.0|-32.8|-8.9|||Kenward Roger|||Week 16||-8.9|-32.8|<0.001
71035078|NCT03100344|141579155|SUPERIORITY||mean difference of percentage changes|-34.3|||<|0.001|TWO_SIDED|95.0|-46.0|-22.6|||Kenward Roger|||Week 16||-22.6|-46.0|<0.001
71096320|NCT04053452|141701468|OTHER|Vagus|Odds Ratio (OR)|0.8968658||||0.511|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.511
70979301|NCT03193866|141466934|SUPERIORITY||Mean Difference (Final Values)|-2.6|||||TWO_SIDED|95.0|-5.9|0.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.8|-5.9|
70979302|NCT03193866|141466934|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-2.9|2.5||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||2.5|-2.9|
70979303|NCT03193866|141466934|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-4.0|1.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.8|-4.0|
70979304|NCT03193866|141466934|SUPERIORITY||Mean Difference (Final Values)|-3.1|||||TWO_SIDED|95.0|-7.0|0.9||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.9|-7.0|
70979305|NCT03193866|141466934|SUPERIORITY||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-2.9|5.4||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||5.4|-2.9|
70979306|NCT03193866|141466935|SUPERIORITY||Mean Difference (Final Values)|-5.5|||||TWO_SIDED|95.0|-8.1|-2.9||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-2.9|-8.1|
70979307|NCT03193866|141466935|SUPERIORITY||Mean Difference (Final Values)|-5.9|||||TWO_SIDED|95.0|-10.9|-1.0||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-1.0|-10.9|
71035079|NCT03100344|141579155|SUPERIORITY||mean difference of percentage changes|-28.7|||<|0.001|TWO_SIDED|95.0|-40.7|-16.8|||Kenward Roger|||Week 16||-16.8|-40.7|<0.001
71035080|NCT03100344|141579155|SUPERIORITY||mean difference of percentage changes|-21.1||||0.001|TWO_SIDED|95.0|-33.7|-8.4|||Kenward Roger|||Week 20||-8.4|-33.7|0.001
71096321|NCT04053452|141701469|OTHER|Median at wrist|Kendall's tau correlation coefficient|-0.057735|||||TWO_SIDED|95.0|-0.4273|0.3293||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.3293|-0.4273|
71035081|NCT03100344|141579155|SUPERIORITY||mean difference of percentage changes|-29.7|||<|0.001|TWO_SIDED|95.0|-42.1|-17.3|||Kenward Roger|||Week 20||-17.3|-42.1|<0.001
71035082|NCT03100344|141579155|SUPERIORITY||mean difference of percentage changes|-27.9|||<|0.001|TWO_SIDED|95.0|-40.6|-15.2|||Kenward Roger|||Week 20||-15.2|-40.6|<0.001
71096322|NCT04053452|141701469|OTHER|Median at forearm|Kendall's tau correlation coefficient|-0.0359442|||||TWO_SIDED|95.0|-0.548|0.5248||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.5248|-0.5480|
71035083|NCT03100344|141579155|SUPERIORITY||mean difference of percentage changes|-22.4||||0.002|TWO_SIDED|95.0|-36.1|-8.6|||Kenward Roger|||Week 24||-8.6|-36.1|0.002
71035084|NCT03100344|141579155|SUPERIORITY||mean difference of percentage changes|-31.5|||<|0.001|TWO_SIDED|95.0|-44.9|-18.0|||Kenward Roger|||Week 24||-18.0|-44.9|<0.001
71035085|NCT03100344|141579155|SUPERIORITY||mean difference of percentage changes|-30.0|||<|0.001|TWO_SIDED|95.0|-43.8|-16.2|||Kenward Roger|||Week 24||-16.2|-43.8|<0.001
71035086|NCT03100344|141579157|SUPERIORITY||Mean Difference (Final Values)|-2.0|||<|0.001|TWO_SIDED|95.0|-3.0|-1.0|||Kenward Roger|||Week 24||-1.0|-3.0|<0.001
71035087|NCT03100344|141579157|SUPERIORITY||Mean Difference (Final Values)|-2.8|||<|0.001|TWO_SIDED|95.0|-3.8|-1.8|||Kenward Roger|||Week 24||-1.8|-3.8|<0.001
71035088|NCT03100344|141579157|SUPERIORITY||Mean Difference (Final Values)|-2.3|||<|0.001|TWO_SIDED|95.0|-3.3|-1.3|||Kenward Roger|||Week 24||-1.3|-3.3|<0.001
71035089|NCT03100344|141579158|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|95.0|-3.0|-0.9|||Kenward Roger|||Week 24||-0.9|-3.0|<0.001
71096323|NCT04053452|141701469|OTHER|Median at cubital fossa|Kendall's tau correlation coefficient|0.1429483|||||TWO_SIDED|95.0|-0.1938|0.4763||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.4763|-0.1938|
70979308|NCT03193866|141466935|SUPERIORITY||Mean Difference (Final Values)|-2.4|||||TWO_SIDED|95.0|-4.0|-0.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-0.8|-4.0|
70979309|NCT03193866|141466935|SUPERIORITY||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-2.1|1.5||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.5|-2.1|
70979310|NCT03193866|141466935|SUPERIORITY||Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-2.2|0.6||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.6|-2.2|
70979311|NCT03193866|141466935|SUPERIORITY||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-0.3|2.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||2.8|-0.3|
70979312|NCT03193866|141466935|SUPERIORITY||Mean Difference (Final Values)|2.7|||||TWO_SIDED|95.0|0.9|4.6||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.6|0.9|
70979313|NCT03193866|141466935|SUPERIORITY||Mean Difference (Final Values)|2.1|||||TWO_SIDED|95.0|0.2|4.0||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.0|0.2|
70979314|NCT02354833|141466942|SUPERIORITY_OR_OTHER|||||||0.12|||||||t-test, 2 sided|||||||0.12
70979315|NCT02354833|141466943|SUPERIORITY_OR_OTHER|||||||0.28|||||||Chi-squared|||This analysis is comparing the percentage of participants with Nausea||||0.28
70979316|NCT02354833|141466943|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||This analysis is comparing the percentage of participants with Emesis||||< 0.001
70979317|NCT02354833|141466944|SUPERIORITY_OR_OTHER|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||0.10
70979318|NCT02354833|141466945|SUPERIORITY_OR_OTHER|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
70979319|NCT05040971|141466946|SUPERIORITY|Week 52 responses were analysed using an analysis of covariance model (ANCOVA) with randomised treatment as factor and baseline body weight as covariate.|Treatment difference|-11.19|||<|0.0001|TWO_SIDED|95.0|-12.97|-9.42|||ANCOVA|||Treatment policy estimand||-9.42|-12.97|<0.0001
70979320|NCT05040971|141466947|SUPERIORITY|Week 52 responses were analysed using a logistic regression model with randomised treatment as factor and baseline glycosylated haemoglobin (HbA1c) and fasting plasma glucose (FPG) as covariates.|Odds Ratio (OR)|19.81|||<|0.0001|TWO_SIDED|95.0|8.68|45.21|||Regression, Logistic|||Treatment policy estimand||45.21|8.68|<0.0001
70979321|NCT02623972|141466964|OTHER||Pathelogic Complete Response Rate|30.0|||||TWO_SIDED||||||Simon minimax two-stage design||Decision Rule: If the percentage of participants experiencing pathologic complete response (pCR) is ≤ 10% then the preoperative regimen is considered minimally effective. If the proportion of pCR ≥ 30% then the regimen is worthy of further study.|Null Hypothesis: the proportion of participants experiencing pCR is ≤ 0.10, Alternative hypothesis that proportion pCR ≥ 0.30. Hypothesized False Positive Rate(α)=10%; Hypothesized False Negative Rate(1-β)=10%.||||
70979322|NCT02623972|141466964|OTHER||Pathelogic Complete Response Rate|23.0|||||TWO_SIDED||||||Simon minimax two-stage design||Decision Rule: If the percentage of participants experiencing pathologic complete response (pCR) is ≤ 2% then the preoperative regimen is considered minimally effective. If the proportion of pCR ≥ 23% then the regimen is worthy of further study.|Null Hypothesis: the proportion of participants experiencing pCR is ≤ 0.02, Alternative hypothesis that proportion pCR ≥ 0.23. Hypothesized False Positive Rate(α)=5%; Hypothesized False Negative Rate(1-β)=10%.||||
70979323|NCT02148029|141467010|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|1.0||0.34|TWO_SIDED|95.0|-1.1|3.1|||t-test, 2 sided||Mean difference = Exercise - Control|||3.1|-1.1|0.34
70979324|NCT02148029|141467011|SUPERIORITY||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|3.5||0.89|TWO_SIDED|95.0|-7.1|8.0|||t-test, 2 sided||Mean difference = Exercise - Control|||8.0|-7.1|0.89
70979325|NCT02148029|141467012|SUPERIORITY||Mean Difference (Net)|-5.8|STANDARD_ERROR_OF_MEAN|7.2||0.43|TWO_SIDED|95.0|-20.3|8.4|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Physical Functioning (PF) domain score.||8.4|-20.3|0.43
70979326|NCT02148029|141467012|SUPERIORITY||Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|3.3||0.13|TWO_SIDED|95.0|-1.6|11.6|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Role limitations due to Physical health problems (RP) domain score.||11.6|-1.6|0.13
71035090|NCT03100344|141579158|SUPERIORITY||Mean Difference (Final Values)|-2.6|||<|0.001|TWO_SIDED|95.0|-3.6|-1.6|||Kenward Roger|||Week 24||-1.6|-3.6|<0.001
71035091|NCT03100344|141579158|SUPERIORITY||Mean Difference (Final Values)|-2.1|||<|0.001|TWO_SIDED|95.0|-3.1|-1.1|||Kenward Roger|||Week 24||-1.1|-3.1|<0.001
70979327|NCT02148029|141467012|SUPERIORITY||Mean Difference (Net)|2.7|STANDARD_ERROR_OF_MEAN|2.8||0.33|TWO_SIDED|95.0|-2.8|8.2|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Role limitations due to mental health or Emotional problems (RE) domain score.||8.2|-2.8|0.33
70979328|NCT02148029|141467012|SUPERIORITY||Mean Difference (Net)|5.6|STANDARD_ERROR_OF_MEAN|7.1||0.43|TWO_SIDED|95.0|-8.7|20.0|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the energy/fatigue/Vitality (VT) domain score.||20.0|-8.7|0.43
70979329|NCT02148029|141467012|SUPERIORITY||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|5.6||0.64|TWO_SIDED|95.0|-13.8|8.6|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Mental Health/emotional well-being (MH) domain score.||8.6|-13.8|0.64
70979330|NCT02148029|141467012|SUPERIORITY||Mean Difference (Net)|-3.9|STANDARD_ERROR_OF_MEAN|8.3||0.64|TWO_SIDED|95.0|-20.5|12.8|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Social Functioning (SF) domain score.||12.8|-20.5|0.64
70979331|NCT02148029|141467012|SUPERIORITY||Mean Difference (Net)|9.5|STANDARD_ERROR_OF_MEAN|10.1||0.35|TWO_SIDED|95.0|-10.7|29.7|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Bodily Pain (BP) domain score.||29.7|-10.7|0.35
70979332|NCT02148029|141467012|SUPERIORITY||Mean Difference (Net)|-3.5|STANDARD_ERROR_OF_MEAN|5.3||0.5|TWO_SIDED|95.0|-14.1|7.0|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the General Health (GH) domain score.||7.0|-14.1|0.50
70979333|NCT02148029|141467013|SUPERIORITY||Mean Difference (Net)|-33.9|STANDARD_ERROR_OF_MEAN|30.1||0.27|TWO_SIDED|95.0|-95.5|27.7|||t-test, 2 sided||Mean difference = Exercise - Control|||27.7|-95.5|0.27
70979334|NCT02148029|141467014|SUPERIORITY||Mean Difference (Net)|-1.6|STANDARD_ERROR_OF_MEAN|0.9||0.07|TWO_SIDED|95.0|-3.4|0.1|||t-test, 2 sided||Mean difference = Reflux - No reflux|||0.1|-3.4|0.07
70979335|NCT02148029|141467015|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.4||0.91|TWO_SIDED|95.0|-0.8|0.9|||t-test, 2 sided||Mean difference = PTS - No PTS|||0.9|-0.8|0.91
70979336|NCT03905928|141467016|SUPERIORITY|||||||||||||||||This was a whole-brain, voxel-wise general linear model conducted in FSL software using a one-sample t-test on the tobacco\>strawberry condition contrasts conducted at the subject-level.|A whole-brain, one-sample t-test was used with a voxel threshold p \<.001 and cluster threshold p\<.05. This method results in unique p-values for each cluster identified.|||
70979337|NCT03905928|141467017|SUPERIORITY|||||||||||||||||This was a whole-brain, voxel-wise repeated measures ANOVA conducted using FSL software on activation from baseline to post-intervention that differ by the nicotine groups (18 mg/ml vs. 0 mg/ml) for the tobacco\>strawberry condition contrasts calculated at the subject-level. The means and standard deviations presented are the average post-pre scan difference scores of the BOLD percentage signal change of tobacco \> strawberry contrasts for each group.|A whole-brain, repeated measures ANOVA was used with a voxel threshold p \<.025 and cluster threshold p\<.05. This method results in unique p-values for each cluster identified.|||
70979338|NCT03905928|141467018|SUPERIORITY|||||||||||||||||This was a whole-brain, voxel-wise repeated measures ANOVA conducted using FSL software on activation from baseline to post-intervention between the flavor groups (tobacco vs. strawberry) for the tobacco\>strawberry condition contrasts calculated at the subject-level. The means and standard deviations presented are the average post-pre scan difference scores of the BOLD percentage signal change of tobacco \> strawberry contrasts for each group.|A whole-brain, repeated measures ANOVA was used with a voxel threshold p \<.025 and cluster threshold p\<.05. This method results in unique p-values for each cluster identified.|||
70979339|NCT03905928|141467019|SUPERIORITY|||||||0.573|||||||ANOVA|||We conducted a one-way ANOVA to compare the change in e-cigarette dependence (week 4 - week 2 PSECDI difference score) between the four e-cigarette groups.||||0.573
70979340|NCT03905928|141467021|SUPERIORITY|||||||0.022|||||||ANOVA|||We conducted a one-way ANOVA to compare changes in self-reported craving across all groups.||||.022
70979341|NCT02688647|141467065|SUPERIORITY|||||||0.5733|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||GAP Stage I-- Difference: Belumosudil-WC minus BSC-NC = 38.85 (95% CI: -126.99, 204.69) mL||||0.5733
70979342|NCT02688647|141467065|SUPERIORITY|||||||0.6967|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||GAP Stage II-- Difference: Belumosudil-WC minus BSC-NC = -39.96 (95% CI: -288.63, 208.71) mL||||0.6967
71096324|NCT04053452|141701469|OTHER|Median at humerus|Kendall's tau correlation coefficient|-0.3955939|||||TWO_SIDED|95.0|-0.6811|-0.0874||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||-0.0874|-0.6811|
70979343|NCT02688647|141467065|SUPERIORITY|||||||0.5003|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||GAP Stage III-- Difference: Belumosudil-WC minus BSC-NC = 94.16 (95% CI: -1103.56, 1291.88) mL||||0.5003
70979344|NCT02688647|141467065|SUPERIORITY|||||||0.4866|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||No Prior Pirfenidone or Nintedanib-- Difference: Belumosudil-WC minus BSC-NC = -34.13 (95% CI: -137.08, 68.82)||||0.4866
70979345|NCT02688647|141467068|SUPERIORITY|GAP Stage I-- Difference: Belumosudil-WC minus BSC-NC = 1.88 (95% CI: -2.69, 6.45)||||||0.3391|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||||||0.3391
70979346|NCT02688647|141467068|SUPERIORITY|GAP Stage II-- Difference: Belumosudil-WC minus BSC-NC = -1.72 (95% CI: -8.13, 4.69)||||||0.5201|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||||||0.5201
70979347|NCT02688647|141467068|SUPERIORITY|GAP Stage III-- Difference: Belumosudil-WC minus BSC-NC = 2.48 (95% CI: -23.84, 28.81)||||||0.4426|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||||||0.4426
70979348|NCT02688647|141467068|SUPERIORITY|No Prior Use of Pirfenidone or Nintedanib-- Difference: Belumosudil-WC minus BSC-NC = 8.70 (95% CI: -78.76, -96.17)||||||0.426|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||||||0.4260
70979349|NCT02688647|141467078|SUPERIORITY|Cox Regression||||||0.8561|TWO_SIDED|95.0|||||Log Rank|||Hazard ratio: 0.86 (0.16, 4.48)||||0.8561
70979350|NCT02688647|141467078|SUPERIORITY|Cox Regression||||||0.8608|TWO_SIDED|95.0|||||Log Rank|||Hazard ratio: 0.87 (95% CI: 0.17, 4.33)||||0.8608
70979351|NCT02688647|141467079|SUPERIORITY|Cox Regression||||||0.0084|TWO_SIDED|95.0|||||Log Rank|||Hazard ratio: 0.34 (95% CI: 0.14, 0.79)||||0.0084
70979352|NCT02688647|141467079|SUPERIORITY|Cox Regression||||||0.0508|TWO_SIDED|95.0|||||Log Rank|||Hazard Ratio: 0.47 (95% CI: 0.22, 1.03)||||0.0508
70979353|NCT02688647|141467081|SUPERIORITY|Cox Regression||||||0.4251|TWO_SIDED|95.0|||||Log Rank|||Hazard ratio: 0.34 (95% CI: 0.02, 5.54)||||0.4251
70979354|NCT02688647|141467081|SUPERIORITY|Cox Regression||||||0.3294|TWO_SIDED|95.0|||||Log Rank|||Hazard ratio: 0.27 (95% CI: 0.02, 4.45)||||0.3294
70979355|NCT03619213|141467083|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0008|TWO_SIDED|95.0|0.73|0.92|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization.||Comparison Group: Placebo||0.92|0.73|0.0008
70979356|NCT03619213|141467084|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0085|TWO_SIDED|95.0|0.73|0.95|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization.||Comparison Group: Placebo||0.95|0.73|0.0085
70979357|NCT03619213|141467085|SUPERIORITY||Rate Ratio (RR)|0.77||||0.0003|TWO_SIDED|95.0|0.67|0.89|||LWYY proportional rates model|Stratified by Type 2 Diabetes status at randomization||Comparison Group: Placebo||0.89|0.67|0.0003
70979358|NCT03619213|141467086|SUPERIORITY||Rate Ratio (RR)|0.77||||0.0017|TWO_SIDED|95.0|0.65|0.9|||LWYY proportional rates model|Stratified by Type 2 Diabetes status at randomization||Comparison Group: Placebo||0.90|0.65|0.0017
70979359|NCT03619213|141467087|SUPERIORITY||Rate Ratio (RR)|1.11||||0.0086|TWO_SIDED|95.0|1.03|1.21||The p-value is obtained from a rank ANCOVA adjusted for baseline KCCQ score, stratified by T2DM status at randomisation.|Win Ratio|Stratified by Type 2 Diabetes status at randomization and including baseline score as a covariate.|The composite of change from baseline in KCCQ Total Symptom Score at 8 months, or death before 8 months.|Comparison Group: Placebo||1.21|1.03|0.0086
70979360|NCT03619213|141467088|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1678|TWO_SIDED|95.0|0.74|1.05|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization.||Comparison Group: Placebo||1.05|0.74|0.1678
71035092|NCT03100344|141579159|SUPERIORITY||mean difference of percentage changes|-23.8|||<|0.001|TWO_SIDED|95.0|-37.7|-9.9|||Kenward Roger|||Week 24||-9.9|-37.7|<0.001
70979361|NCT03619213|141467089|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.3425|TWO_SIDED|95.0|0.83|1.07|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization.||Comparison Group: Placebo||1.07|0.83|0.3425
70979362|NCT00331760|141467133|SUPERIORITY|||||||0.12|||||||Chi-squared|||A sample size of 42 patients provides 64% power to detect a reduction in short-term grade 2 or higher bowel AEs from historical rate of 40% to 25%.||||0.12
70979363|NCT00331760|141467133|SUPERIORITY|||||||0.043|||||||Chi-squared|||A sample size of 42 patients provides 88% power to detect a reduction in short-term grade 2 or higher bowel AEs from historical rate of 40% to 20%.||||0.043
70979364|NCT02514044|141467141|OTHER|"We also performed normalization by calculating the dependent variable as the percentage of change (proportional change) as it follows; (1) (post-active values - pre-active values)/ (pre-active values) and (2) (post-placebo values - pre-placebo values)/ (pre-placebo series). We compared the percentage of change in Bedside WAB-R® aphasia and language quotients and blood pressures for the experiments with active- and placebo drugs combined active tDCS with MIT using a two-tailed paired t-test."||||||0.008|||||||t-test, 2 sided|||We tested normality using the Kolmogorov-Smirnov (KS) test for all reported measures. We compared scores of Bedside WAB-R® subtests Bedside WAB-R® AQ and LQ from before the study intervention and after the intervention in both experiments by using a two-tailed and paired t-test.||||0.008
70979365|NCT02514044|141467142|OTHER|"We also performed normalization by calculating the dependent variable as the percentage of change (proportional change) as it follows; (1) (post-active values - pre-active values)/ (pre-active values) and (2) (post-placebo values - pre-placebo values)/ (pre-placebo series). We compared the percentage of change in Bedside WAB-R® aphasia and language quotients and blood pressures for the experiments with active- and placebo drugs combined active tDCS with MIT using a two-tailed paired t-test."||||||0.02|TWO_SIDED|95.0|||||t-test, 2 sided|||We tested normality using the Kolmogorov-Smirnov (KS) test for all reported measures. We compared scores of Bedside WAB-R® subtests Bedside WAB-R® AQ and LQ from before the study intervention and after the intervention in both experiments by using a two-tailed and paired t-test.||||0.02
70979366|NCT03093155|141467146|SUPERIORITY||Hazard Ratio (HR)|0.31|||<|0.001|TWO_SIDED|90.0|0.2|0.49|||Regression, Cox|||||0.49|0.20|<0.001
70979367|NCT03093155|141467147|SUPERIORITY|||||||0.003|||||||Fisher Exact|||||||0.003
70979368|NCT03093155|141467148|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.018|TWO_SIDED|90.0|0.38|0.84|||Regression, Cox|||||0.84|0.38|0.018
70979369|NCT03093155|141467149|SUPERIORITY|||||||0.77|||||||Fisher Exact|||||||0.77
70979370|NCT03093155|141467150|SUPERIORITY|||||||0.068|||||||Fisher Exact|||The RECIST responses were categorized as SD/PD or NA compared to PR or Better as a binary outcome.||||0.068
71008765|NCT02055976|141525252|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-103.386|STANDARD_ERROR_OF_MEAN|6.525|<|0.001|TWO_SIDED|95.0|-116.353|-90.42|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-90.420|-116.353|<0.001
71008766|NCT02055976|141525252|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.124|STANDARD_ERROR_OF_MEAN|5.382|<|0.001|TWO_SIDED|95.0|-71.813|-50.435|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-50.435|-71.813|<0.001
71035093|NCT03100344|141579159|SUPERIORITY||mean difference of percentage changes|-31.4|||<|0.001|TWO_SIDED|95.0|-45.0|-17.7|||Kenward Roger|||Week 24||-17.7|-45.0|<0.001
71035094|NCT03100344|141579159|SUPERIORITY||mean difference of percentage changes|-29.2|||<|0.001|TWO_SIDED|95.0|-43.2|-15.2|||Kenward Roger|||Week 24||-15.2|-43.2|<0.001
71035095|NCT01935674|141579166|SUPERIORITY||Mean Difference (Net)|12.7||||0.003|TWO_SIDED|95.0|2.9|22.5||P-value from Wilcoxon rank-sum test; significance threshold set at α = 0.05. No adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|Two-sided test; analysis based on intention-to-treat population.||Comparison of percentage change in fasting total cholesterol from baseline to week 12 between rosuvastatin and PI/r switch groups. Wilcoxon rank-sum test used. Study powered to detect a 15% difference with 80% power and α = 0.05. All participants included in intention-to-treat analysis.||22.5|2.9|0.003
70979371|NCT01075178|141467152|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was assessed with a 95% 1-sided confidence interval for which the upper bound of the difference in the event rates (CASES minus CONTROLS) will correspond to an odds ratio less than 2 (that is, the odds ratio calculated at the upper confidence bound of the difference in event rates will be less than 2).|Observed odds ratio|0.81|||||ONE_SIDED|95.0||0.96|||exact binomial||"Result provided for 95% Confidence Interval (1-Sided) is the odds ratio calculated at the upper bound of the 1-sided 95% confidence interval for the difference in event rates (CASES minus CONTROLS)."|The null hypothesis was that the odds ratio was greater than or equal to 2. The planned sample size of 2000 participants (1000 participants in each group) provided greater than 90% power to determine non-inferiority based on the odds ratio less than 2.||0.96||
70979372|NCT01075178|141467153|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was assessed with a 95% 1-sided confidence interval for which the upper bound of the difference in the event rates (CASES minus CONTROLS) will correspond to an odds ratio less than 2 (that is, the odds ratio calculated at the upper confidence bound of the difference in event rates will be less than 2).|Observed odds ratio|0.8|||||ONE_SIDED|95.0||0.95|||exact binomial||"Result provided for 95% Confidence Interval (1-Sided) is the odds ratio calculated at the upper bound of the 1-sided 95% confidence interval for the difference in event rates (CASES minus CONTROLS)."|The null hypothesis was that the odds ratio was greater than or equal to 2. The planned sample size of 2000 participants (1000 participants in each group) provided greater than 90% power to determine non-inferiority based on the odds ratio less than 2.||0.95||
70979373|NCT01075178|141467154|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was assessed with a 95% 1-sided confidence interval for which the upper bound of the difference in the event rates (CASES minus CONTROLS) will correspond to an odds ratio less than 2 (that is, the odds ratio calculated at the upper confidence bound of the difference in event rates will be less than 2).|Observed odds ratio|1.05|||||ONE_SIDED|95.0||1.64|||exact binomial||"Result provided for 95% Confidence Interval (1-Sided) is the odds ratio calculated at the upper bound of the 1-sided 95% confidence interval for the difference in event rates (CASES minus CONTROLS)."|The null hypothesis was that the odds ratio was greater than or equal to 2. The planned sample size of 2000 participants (1000 participants in each group) provided greater than 90% power to determine non-inferiority based on the odds ratio less than 2.||1.64||
70979374|NCT01075178|141467155|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was assessed with a 95% 1-sided confidence interval for which the upper bound of the difference in the event rates (CASES minus CONTROLS) will correspond to an odds ratio less than 2 (that is, the odds ratio calculated at the upper confidence bound of the difference in event rates will be less than 2).|Observed odds ratio|0.9|||||ONE_SIDED|95.0||2.19|||exact binomial||"Result provided for 95% Confidence Interval (1-Sided) is the odds ratio calculated at the upper bound of the 1-sided 95% confidence interval for the difference in event rates (CASES minus CONTROLS)."|The null hypothesis was that the odds ratio was greater than or equal to 2. The planned sample size of 2000 participants (1000 participants in each group) provided greater than 90% power to determine non-inferiority based on the odds ratio less than 2.||2.19||
70979375|NCT00826514|141467219|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.392|||TWO_SIDED|95.0|-1.15|0.209||||||Analysis was based on analysis of co-variance (ANCOVA) model with baseline value, age and treatment as covariates.||0.209|-1.150|
70979376|NCT00826514|141467222|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.42|STANDARD_ERROR_OF_MEAN|1.901|||TWO_SIDED|90.0|-4.754|1.905||||||Change at Week 6, CPSI Total Score: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||1.905|-4.754|
70979377|NCT00826514|141467222|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.06|STANDARD_ERROR_OF_MEAN|0.931|||TWO_SIDED|90.0|-2.701|0.591||||||Change at Week 6, CPSI PD Score: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||0.591|-2.701|
70979378|NCT00826514|141467222|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.38|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|90.0|-0.789|1.541||||||Change at Week 6, CPSI US Score: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||1.541|-0.789|
70979379|NCT00826514|141467222|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.697|||TWO_SIDED|90.0|-1.785|0.631||||||Change at Week 6, CPSI QoL Score: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||0.631|-1.785|
70979380|NCT00826514|141467223|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.649|||TWO_SIDED|90.0|-0.99|1.348||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||1.348|-0.990|
70979381|NCT00826514|141467224|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.93|||TWO_SIDED|90.0|-1.829|1.452||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||1.452|-1.829|
70979382|NCT00826514|141467225|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-33.56|STANDARD_ERROR_OF_MEAN|17.026|||TWO_SIDED|90.0|-64.144|-2.968||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||-2.968|-64.144|
70979383|NCT00826514|141467226|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.489|||TWO_SIDED|90.0|-1.364|0.415||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||0.415|-1.364|
71035096|NCT01494532|141579174|SUPERIORITY_OR_OTHER|||||||0.814||95.0||||P-values were estimated from Mixed Model Repeated Measures (MMRM).|Mixed Models Analysis|||4mg/day vs Placebo||||0.814
71035097|NCT01494532|141579174|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-values were estimated from Mixed Model Repeated Measures (MMRM).|Mixed Models Analysis|||8 mg/day vs Placebo||||0.013
71035098|NCT01494532|141579174|SUPERIORITY_OR_OTHER|||||||0.287||95.0||||P-values were estimated from Mixed Model Repeated Measures (MMRM).|Mixed Models Analysis|||12 mg/day vs Placebo||||0.287
71035099|NCT01494532|141579174|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||P-values were estimated from Mixed Model Repeated Measures (MMRM).|Mixed Models Analysis|||16 mg/day vs Placebo||||0.027
71096325|NCT04053452|141701469|OTHER|Median at axilla|Kendall's tau correlation coefficient|-0.3681051|||||TWO_SIDED|95.0|-0.7032|0.1185||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.1185|-0.7032|
71096326|NCT04053452|141701469|OTHER|Ulnar at wrist|Kendall's tau correlation coefficient|-0.4938292|||||TWO_SIDED|95.0|-0.7112|-0.1978||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||-0.1978|-0.7112|
70979384|NCT00826514|141467227|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.37|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|90.0|-3.146|0.401||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||0.401|-3.146|
70979385|NCT00826514|141467228|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.217|||TWO_SIDED|90.0|-0.417|0.334||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||0.334|-0.417|
70979386|NCT00826514|141467229|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.765|||TWO_SIDED|90.0|-1.791|1.822||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||1.822|-1.791|
70979387|NCT00826514|141467230|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.833|||||TWO_SIDED|90.0|0.763|4.407||||||Week 6: Logistic regression model with age, baseline pain stratification group and treatment as covariates.||4.407|0.763|
70979388|NCT00826514|141467230|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0|||||TWO_SIDED|90.0|0.388|2.575||||||Week 16: Logistic regression model with age, baseline pain stratification group and treatment as covariates.||2.575|0.388|
70979389|NCT01834404|141467293|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED||||||ANCOVA|||||||0.057
70979390|NCT01834404|141467294|SUPERIORITY_OR_OTHER|||||||0.052|TWO_SIDED||||||ANCOVA|||||||0.052
71035100|NCT01494532|141579174|SUPERIORITY_OR_OTHER|||||||0.39||95.0||||P-values were estimated from Mixed Model Repeated Measures (MMRM).|Mixed Models Analysis|||24 mg/day vs Placebo||||0.390
71035101|NCT01494532|141579174|SUPERIORITY_OR_OTHER|||||||0.844||95.0||||P-values are from a nonparametric rank ANCOVA|ANCOVA|||4mg/day vs Placebo||||0.844
71035102|NCT01494532|141579174|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-values are from a nonparametric rank ANCOVA|ANCOVA|||8 mg/day vs Placebo||||0.030
71096327|NCT04053452|141701469|OTHER|Ulnar at forearm|Kendall's tau correlation coefficient|0.1304373|||||TWO_SIDED|95.0|-0.2201|0.5014||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.5014|-0.2201|
70979391|NCT01834404|141467295|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||ANCOVA|||||||0.36
70979392|NCT01834404|141467296|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||ANCOVA|||||||0.99
70979393|NCT01834404|141467297|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||ANCOVA|||||||0.45
70979394|NCT01834404|141467298|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||ANCOVA|||||||0.22
70979395|NCT01834404|141467299|SUPERIORITY_OR_OTHER|||||||0.032|TWO_SIDED||||||ANCOVA|||||||0.032
71096328|NCT04053452|141701469|OTHER|Ulnar at cubital fossa|Kendall's tau correlation coefficient|0.3273268|||||TWO_SIDED|95.0|-0.0679|0.6612||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.6612|-0.0679|
70979396|NCT01834404|141467300|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||ANCOVA|||This p-value was based on a rank transformation.||||0.030
70979397|NCT01834404|141467301|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||ANCOVA|||||||0.35
70979398|NCT01834404|141467302|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||ANCOVA|||||||0.72
70979399|NCT01834404|141467303|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||ANCOVA|||||||0.90
70979400|NCT01834404|141467304|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.54
70979401|NCT01834404|141467305|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.26
70979402|NCT02203149|141467311|SUPERIORITY_OR_OTHER||Difference in Percentage|-2.8|||||TWO_SIDED|95.0|-14.5|10.0|||Miettinen and Nurminen Method|||95% confidence intervals were provided for between-treatment differences in the percentage of participants with events, comparing participants in the Part 2 Immediate Treatment (Grazoprevir + Elbasvir) Arm with the Part 2 Deferred Treatment (Placebo) Arm during the double blinded period through FUWK4. These analyses were performed using the Miettinen and Nurminen method, an unconditional, asymptotic method.||10.0|-14.5|
70979403|NCT02203149|141467312|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-6.0|2.8|||Miettinen and Nurminen Method|||95% confidence intervals were provided for between-treatment differences in the percentage of participants with events, comparing participants in the Part 2 Immediate Treatment (Grazoprevir + Elbasvir) Arm with the Part 2 Deferred Treatment (Placebo) Arm during the double blinded period through FUWK4. These analyses were performed using the Miettinen and Nurminen method, an unconditional, asymptotic method.||2.8|-6.0|
70979404|NCT01360996|141467315|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||||||<.0001
71096329|NCT04053452|141701469|OTHER|Ulnar at humerus|Kendall's tau correlation coefficient|-0.0552157|||||TWO_SIDED|95.0|-0.4213|0.361||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.3610|-0.4213|
71035103|NCT01494532|141579174|SUPERIORITY_OR_OTHER|||||||0.437||95.0||||P-values are from a nonparametric rank ANCOVA|ANCOVA|||12 mg/day vs Placebo||||0.437
71035104|NCT01494532|141579174|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||P-values are from a nonparametric rank ANCOVA|ANCOVA|||16 mg/day vs Placebo||||0.034
71035105|NCT01494532|141579174|SUPERIORITY_OR_OTHER|||||||0.808||95.0||||P-values are from a nonparametric rank ANCOVA|ANCOVA|||24 mg/day vs Placebo||||0.808
71035106|NCT01494532|141579175|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.123||||0.826|TWO_SIDED|95.0|0.398|3.166|||Generalized Estimating Equations model|||||3.166|0.398|0.826
71035107|NCT01494532|141579175|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.622||||0.233|TWO_SIDED|95.0|0.732|3.593|||Generalized Estimating Equations model|||||3.593|0.732|0.233
71035108|NCT01494532|141579175|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.953||||0.902|TWO_SIDED|95.0|0.439|2.065|||Generalized Estimating Equations model|||||2.065|0.439|0.902
71035109|NCT01494532|141579175|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.866||||0.127|TWO_SIDED|95.0|0.837|4.158|||Generalized Estimating Equations model|||||4.158|0.837|0.127
71035110|NCT01494532|141579175|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.362||||0.564|TWO_SIDED|95.0|0.477|3.888|||Generalized Estimating Equations model|||||3.888|0.477|0.564
71096330|NCT04053452|141701469|OTHER|Ulnar at axilla|Kendall's tau correlation coefficient|-0.1666667|||||TWO_SIDED|95.0|-0.5389|0.2057||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.2057|-0.5389|
70979405|NCT01360996|141467316|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
70979406|NCT01360996|141467317|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
70979407|NCT01360996|141467318|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
70979408|NCT01360996|141467319|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||McNemar|||||||<0.0001
70979409|NCT01360996|141467320|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
70979410|NCT01360996|141467321|SUPERIORITY_OR_OTHER||||||<|0.04|||||||ANOVA|||||||<0.04
70979411|NCT01478958|141467345|SUPERIORITY_OR_OTHER|||||||0.238||||||Overall diet effect. No post-hoc analyses required. Adjusted for multiple comparisons.|General Linear Model Univariate Analysis|Baseline values for %FMD, BMI, age, gender and intervention diet used as prognostic factors in model.||To detect a 2% inter-group difference in FMD (primary outcome) using a SD of 2.3, 90% power and 5% significance level, n=171 participants were required (n=57 per group), increasing to n=228 to include a 25% dropout rate.||||0.238
70979412|NCT01478958|141467345|SUPERIORITY_OR_OTHER|||||||0.021||||||Effect of the SFA-rich diet relative to baseline.|General Linear Model Univariate Analysis|Baseline values for %FMD, BMI and age, gender and intervention diet were used as prognostic factors in the model.||||||0.021
70979413|NCT01478958|141467345|SUPERIORITY_OR_OTHER||||||>|0.05||||||Effect of MUFA-rich diet relative to baseline.|General Linear Model Univariate Analysis|Baseline values for %FMD, BMI and age, gender and intervention diet were used as prognostic factors in the model.||||||>0.05
70979414|NCT01478958|141467345|SUPERIORITY_OR_OTHER||||||>|0.05||||||Effect of n-6 PUFA-rich diet relative to baseline.|General Linear Model Univariate Analysis|Baseline values for %FMD, BMI and age, gender and intervention diet were used as prognostic factors in the model.||||||>0.05
70979415|NCT03896581|141467392|SUPERIORITY||Odds Ratio (OR)|11.139|||<|0.001|TWO_SIDED|95.0|5.402|22.969|||Regression, Logistic|||||22.969|5.402|<0.001
70979416|NCT03896581|141467393|SUPERIORITY||Least square (LS) mean difference|-0.326|||<|0.001|TWO_SIDED|95.0|-0.42|-0.233|||ANCOVA|||||-0.233|-0.420|<0.001
70979417|NCT03896581|141467395|SUPERIORITY||Odds Ratio (OR)|30.237|||<|0.001|TWO_SIDED|95.0|12.365|73.94|||Regression, Logistic|||||73.940|12.365|<0.001
70979418|NCT03896581|141467396|SUPERIORITY||LS mean difference|6.037|||<|0.001|TWO_SIDED|95.0|4.386|7.688|||ANCOVA|||||7.688|4.386|<0.001
70979419|NCT03896581|141467397|SUPERIORITY||Odds Ratio (OR)|13.089|||<|0.001|TWO_SIDED|95.0|6.119|27.999|||Regression, Logistic|||||27.999|6.119|<0.001
70979420|NCT03797001|141467417|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.60
70979421|NCT00960076|141467457|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.108|||TWO_SIDED|95.0|-0.73|-0.31||||||||-0.31|-0.73|
70979422|NCT00960076|141467458|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.32|STANDARD_ERROR_OF_MEAN|7.128|||TWO_SIDED|95.0|-37.36|-9.28||||||||-9.28|-37.36|
70979423|NCT00960076|141467459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.18|STANDARD_ERROR_OF_MEAN|4.409|||TWO_SIDED|95.0|-21.86|-4.5||||||||-4.50|-21.86|
70979424|NCT00960076|141467460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.2||||0.0459|TWO_SIDED|95.0|0.2|22.0|||ANCOVA|||||22.0|0.2|0.0459
70979425|NCT01431287|141467464|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.108|0.157||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.157|0.108|<0.0001
70979426|NCT01431287|141467464|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.103|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.078|0.127||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.127|0.078|<0.0001
70979427|NCT01431287|141467464|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.121|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.096|0.145||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.145|0.096|< 0.0001
70979428|NCT01431287|141467464|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.131|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.106|0.155||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.155|0.106|<0.0001
70979429|NCT01431287|141467464|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.091|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.066|0.115||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.115|0.066|<0.0001
71035111|NCT01494532|141579176|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.908||||0.861|TWO_SIDED|95.0|0.31|2.659|||Generalized Estimating Equations model|||||2.659|0.310|0.861
71035112|NCT01494532|141579176|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.608||||0.277|TWO_SIDED|95.0|0.684|3.782|||Generalized Estimating Equations model|||||3.782|0.684|0.277
71035113|NCT01494532|141579176|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.074||||0.869|TWO_SIDED|95.0|0.461|2.5|||Generalized Estimating Equations model|||||2.500|0.461|0.869
71035114|NCT01494532|141579176|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.916||||0.14|TWO_SIDED|95.0|0.808|4.545|||Generalized Estimating Equations model|||||4.545|0.808|0.140
71035115|NCT01494532|141579176|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.689||||0.362|TWO_SIDED|95.0|0.547|5.218|||Generalized Estimating Equations model|||||5.218|0.547|0.362
70979430|NCT01431287|141467464|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.012||0.3394|TWO_SIDED|95.0|-0.013|0.036||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.036|-0.013|0.3394
70979431|NCT01431287|141467464|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.143|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.118|0.167||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.167|0.118|<0.0001
70979432|NCT01431287|141467464|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.012||0.0173|TWO_SIDED|95.0|0.005|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.054|0.005|0.0173
70979433|NCT01431287|141467464|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.013||0.421|TWO_SIDED|95.0|-0.035|0.014||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.014|-0.035|0.4210
70979434|NCT01431287|141467464|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.012||0.0014|TWO_SIDED|95.0|0.015|0.064||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.064|0.015|0.0014
70979435|NCT01431287|141467465|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.088|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.063|0.113||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.113|0.063|<0.0001
70979436|NCT01431287|141467465|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.013||0.0001|TWO_SIDED|95.0|0.024|0.075||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.075|0.024|0.0001
70979437|NCT01431287|141467465|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.067|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.042|0.092||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.092|0.042|<0.0001
70979438|NCT01431287|141467465|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.062|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.037|0.087||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.087|0.037|<0.0001
70979439|NCT01431287|141467465|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.029|STANDARD_ERROR_OF_MEAN|0.013||0.0231|TWO_SIDED|95.0|0.004|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.054|0.004|0.0231
70979440|NCT01431287|141467465|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.013||0.1073|TWO_SIDED|95.0|-0.004|0.046||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.046|-0.004|0.1073
70979441|NCT01431287|141467465|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.083|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.058|0.108||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.108|0.058|<0.0001
70979442|NCT01431287|141467465|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.038|STANDARD_ERROR_OF_MEAN|0.013||0.0029|TWO_SIDED|95.0|0.013|0.063||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.063|0.013|0.0029
70979443|NCT01431287|141467465|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.005|STANDARD_ERROR_OF_MEAN|0.013||0.6939|TWO_SIDED|95.0|-0.02|0.03||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.030|-0.020|0.6939
71035116|NCT01494532|141579177|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.723||||0.525|TWO_SIDED|95.0|0.266|1.965|||Generalized Estimating Equations model|||||1.965|0.266|0.525
70979444|NCT01431287|141467465|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.033|STANDARD_ERROR_OF_MEAN|0.013||0.0097|TWO_SIDED|95.0|0.008|0.058||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.058|0.008|0.0097
70979445|NCT01431287|141467466|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.693|STANDARD_ERROR_OF_MEAN|0.553||0.0022|TWO_SIDED|95.0|-2.778|-0.608||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||-0.608|-2.778|0.0022
70979446|NCT01431287|141467466|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.233|STANDARD_ERROR_OF_MEAN|0.551||0.0252|TWO_SIDED|95.0|-2.313|-0.153||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||-0.153|-2.313|0.0252
70979447|NCT01431287|141467466|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.031|STANDARD_ERROR_OF_MEAN|0.552||0.062|TWO_SIDED|95.0|-2.113|0.052||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.052|-2.113|0.0620
70979448|NCT01431287|141467466|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.456|STANDARD_ERROR_OF_MEAN|0.548||0.4051|TWO_SIDED|95.0|-1.531|0.618||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.618|-1.531|0.4051
70979449|NCT01431287|141467466|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.571|STANDARD_ERROR_OF_MEAN|0.55||0.2988|TWO_SIDED|95.0|-1.649|0.507||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.507|-1.649|0.2988
70979450|NCT01431287|141467466|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.662|STANDARD_ERROR_OF_MEAN|0.545||0.2249|TWO_SIDED|95.0|-1.731|0.407||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.407|-1.731|0.2249
70979451|NCT01431287|141467466|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.118|STANDARD_ERROR_OF_MEAN|0.549||0.0418|TWO_SIDED|95.0|-2.195|-0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||-0.042|-2.195|0.0418
70979452|NCT01431287|141467466|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.557||0.4097|TWO_SIDED|95.0|-1.552|0.633||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.633|-1.552|0.4097
70979453|NCT01431287|141467466|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.575|STANDARD_ERROR_OF_MEAN|0.556||0.3013|TWO_SIDED|95.0|-1.664|0.515||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.515|-1.664|0.3013
70979454|NCT01431287|141467466|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.115|STANDARD_ERROR_OF_MEAN|0.554||0.8355|TWO_SIDED|95.0|-0.97|1.2||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||1.200|-0.970|0.8355
70979455|NCT01431287|141467467|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.135||0.0019|TWO_SIDED|95.0|0.155|0.684||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.684|0.155|0.0019
70979456|NCT01431287|141467467|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.356|STANDARD_ERROR_OF_MEAN|0.135||0.0082|TWO_SIDED|95.0|0.092|0.619||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.619|0.092|0.0082
71035117|NCT01494532|141579177|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.851||||0.13|TWO_SIDED|95.0|0.834|4.109|||Generalized Estimating Equations model|||||4.109|0.834|0.130
70979457|NCT01431287|141467467|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.416|STANDARD_ERROR_OF_MEAN|0.135||0.002|TWO_SIDED|95.0|0.152|0.681||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.681|0.152|0.0020
70979458|NCT01431287|141467467|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.134||0.0307|TWO_SIDED|95.0|0.027|0.554||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.554|0.027|0.0307
70979459|NCT01431287|141467467|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.352|STANDARD_ERROR_OF_MEAN|0.135||0.0088|TWO_SIDED|95.0|0.089|0.616||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.616|0.089|0.0088
70979460|NCT01431287|141467467|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.003|STANDARD_ERROR_OF_MEAN|0.134||0.9801|TWO_SIDED|95.0|-0.259|0.266||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.266|-0.259|0.9801
70979461|NCT01431287|141467467|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.294|STANDARD_ERROR_OF_MEAN|0.134||0.0289|TWO_SIDED|95.0|0.03|0.557||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.557|0.030|0.0289
70979462|NCT01431287|141467467|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.136||0.6382|TWO_SIDED|95.0|-0.202|0.33||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.330|-0.202|0.6382
70979463|NCT01431287|141467467|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.126|STANDARD_ERROR_OF_MEAN|0.135||0.3525|TWO_SIDED|95.0|-0.14|0.391||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.391|-0.140|0.3525
70979464|NCT01431287|141467467|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.062|STANDARD_ERROR_OF_MEAN|0.135||0.6457|TWO_SIDED|95.0|-0.327|0.203||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.203|-0.327|0.6457
70979465|NCT01431287|141467468|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.033|STANDARD_ERROR_OF_MEAN|0.013||0.0095|TWO_SIDED|95.0|0.008|0.058||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.058|0.008|0.0095
70979466|NCT01431287|141467468|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.04|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.090|0.040|<0.0001
70979467|NCT01431287|141467468|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.033|STANDARD_ERROR_OF_MEAN|0.013||0.0112|TWO_SIDED|95.0|0.007|0.058||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.058|0.007|0.0112
71035118|NCT01494532|141579177|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.996||||0.992|TWO_SIDED|95.0|0.444|2.232|||Generalized Estimating Equations model|||||2.232|0.444|0.992
71035119|NCT01494532|141579177|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.329|TWO_SIDED|95.0|0.674|3.248|||Generalized Estimating Equations model|||||3.248|0.674|0.329
71035120|NCT01494532|141579177|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.907||||0.856|TWO_SIDED|95.0|0.315|2.61|||Generalized Estimating Equations model|||||2.610|0.315|0.856
71035121|NCT01494532|141579179|SUPERIORITY_OR_OTHER|||||||0.376|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.376
71035122|NCT01494532|141579179|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.036
71035123|NCT01494532|141579179|SUPERIORITY_OR_OTHER|||||||0.362|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.362
71035124|NCT01494532|141579179|SUPERIORITY_OR_OTHER|||||||0.089|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.089
71096331|NCT04053452|141701469|OTHER|C6|Kendall's tau correlation coefficient|-0.3194892|||||TWO_SIDED|95.0|-0.6539|0.2288||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.2288|-0.6539|
71096332|NCT04053452|141701469|OTHER|C7|Kendall's tau correlation coefficient|-0.4959498|||||TWO_SIDED|95.0|-0.686|-0.2065||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||-0.2065|-0.6860|
71096333|NCT04053452|141701469|OTHER|Vagus|Kendall's tau correlation coefficient|-0.3228883|||||TWO_SIDED|95.0|-0.6487|0.0||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.0000|-0.6487|
71096334|NCT04053452|141701470|OTHER|Median at wrist|Kendall's tau correlation coefficient|-0.1415346|||||TWO_SIDED|95.0|-0.735|0.4247||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.4247|-0.7350|
71096335|NCT04053452|141701470|OTHER|Median at forearm|Kendall's tau correlation coefficient|0.1987845|||||TWO_SIDED|95.0|-0.4377|0.8004||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.8004|-0.4377|
70979468|NCT01431287|141467468|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.093|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.068|0.119||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.119|0.068|<0.0001
70979469|NCT01431287|141467468|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.039|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.090|0.039|<0.0001
70979470|NCT01431287|141467468|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.013||0.9514|TWO_SIDED|95.0|-0.024|0.026||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.026|-0.024|0.9514
70979471|NCT01431287|141467468|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.069|0.119||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.119|0.069|<0.0001
70979472|NCT01431287|141467468|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.032|STANDARD_ERROR_OF_MEAN|0.013||0.0131|TWO_SIDED|95.0|-0.057|-0.007||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.007|-0.057|0.0131
70979473|NCT01431287|141467468|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.061|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|-0.086|-0.036||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.036|-0.086|<0.0001
70979474|NCT01431287|141467468|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.029|STANDARD_ERROR_OF_MEAN|0.013||0.0243|TWO_SIDED|95.0|0.004|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.054|0.004|0.0243
70979475|NCT01431287|141467469|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.145|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.119|0.17||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.170|0.119|<0.0001
71035125|NCT01494532|141579179|SUPERIORITY_OR_OTHER|||||||0.403|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.403
71035126|NCT01494532|141579180|SUPERIORITY_OR_OTHER|||||||0.419|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.419
71035127|NCT01494532|141579180|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.026
71035128|NCT01494532|141579180|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.230
71035129|NCT01494532|141579180|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.033
71035130|NCT01494532|141579180|SUPERIORITY_OR_OTHER|||||||0.266|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.266
71035131|NCT01494532|141579181|SUPERIORITY_OR_OTHER|||||||0.073|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.073
71035132|NCT01494532|141579181|SUPERIORITY_OR_OTHER|||||||0.996|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.996
71035133|NCT01494532|141579181|SUPERIORITY_OR_OTHER|||||||0.791|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.791
71035134|NCT01494532|141579181|SUPERIORITY_OR_OTHER|||||||0.747|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.747
71035135|NCT01494532|141579181|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.600
71035136|NCT01494532|141579182|SUPERIORITY_OR_OTHER|||||||0.998|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.998
70979476|NCT01431287|141467469|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.111|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.085|0.136||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.136|0.085|<0.0001
71096336|NCT04053452|141701470|OTHER|Median at cubital fossa|Kendall's tau correlation coefficient|-0.0789747|||||TWO_SIDED|95.0|-0.5256|0.3778||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.3778|-0.5256|
70979477|NCT01431287|141467469|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.119|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.094|0.144||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.144|0.094|<0.0001
70979478|NCT01431287|141467469|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.106|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.081|0.132||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.132|0.081|<0.0001
70979479|NCT01431287|141467469|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.085|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.059|0.11||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.110|0.059|<0.0001
70979480|NCT01431287|141467469|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.026|STANDARD_ERROR_OF_MEAN|0.013||0.047|TWO_SIDED|95.0|0.0|0.051||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.051|0.000|0.0470
70979481|NCT01431287|141467469|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.107|0.158||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.158|0.107|<0.0001
70979482|NCT01431287|141467469|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.034|STANDARD_ERROR_OF_MEAN|0.013||0.0083|TWO_SIDED|95.0|0.009|0.06||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.060|0.009|0.0083
70979483|NCT01431287|141467469|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.013|STANDARD_ERROR_OF_MEAN|0.013||0.3329|TWO_SIDED|95.0|-0.013|0.038||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.038|-0.013|0.3329
70979484|NCT01431287|141467469|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.022|STANDARD_ERROR_OF_MEAN|0.013||0.0958|TWO_SIDED|95.0|-0.004|0.047||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.047|-0.004|0.0958
70979485|NCT01431287|141467470|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.105|0.158||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.158|0.105|<0.0001
70979486|NCT01431287|141467470|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.112|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.086|0.139||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.139|0.086|<0.0001
70979487|NCT01431287|141467470|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.118|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.092|0.144||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.144|0.092|<0.0001
70979488|NCT01431287|141467470|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.118|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.092|0.144||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.144|0.092|<0.0001
71096337|NCT04053452|141701470|OTHER|Median at humerus|Kendall's tau correlation coefficient|0.1621509|||||TWO_SIDED|95.0|-0.3591|0.5606||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.5606|-0.3591|
71096338|NCT04053452|141701470|OTHER|Median at axilla|Kendall's tau correlation coefficient|0.1499412|||||TWO_SIDED|95.0|-0.3901|0.6374||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.6374|-0.3901|
71096339|NCT04053452|141701470|OTHER|Ulnar at wrist|Kendall's tau correlation coefficient|-0.0140441|||||TWO_SIDED|95.0|-0.5773|0.5407||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.5407|-0.5773|
70979489|NCT01431287|141467470|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.098|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.072|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.125|0.072|<0.0001
70979490|NCT01431287|141467470|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.014|STANDARD_ERROR_OF_MEAN|0.013||0.3008|TWO_SIDED|95.0|-0.012|0.04||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.040|-0.012|0.3008
70979491|NCT01431287|141467470|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.105|0.158||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.158|0.105|<0.0001
70979492|NCT01431287|141467470|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.014||0.1484|TWO_SIDED|95.0|-0.007|0.046||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.046|-0.007|0.1484
70979493|NCT01431287|141467470|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.014||0.9981|TWO_SIDED|95.0|-0.026|0.027||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.027|-0.026|0.9981
70979494|NCT01431287|141467470|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.013||0.148|TWO_SIDED|95.0|-0.007|0.046||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.046|-0.007|0.1480
70979495|NCT01431287|141467471|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.04|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.090|0.040|<0.0001
70979496|NCT01431287|141467471|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.036|STANDARD_ERROR_OF_MEAN|0.013||0.005|TWO_SIDED|95.0|0.011|0.061||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.061|0.011|0.0050
70979497|NCT01431287|141467471|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.039|0.089||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.089|0.039|<0.0001
70979498|NCT01431287|141467471|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.037|0.088||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.088|0.037|<0.0001
70979499|NCT01431287|141467471|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.036|STANDARD_ERROR_OF_MEAN|0.013||0.0057|TWO_SIDED|95.0|0.01|0.061||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.061|0.010|0.0057
70979500|NCT01431287|141467471|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.013||0.9633|TWO_SIDED|95.0|-0.025|0.026||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.026|-0.025|0.9633
70979501|NCT01431287|141467471|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.038|0.088||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.088|0.038|<0.0001
71096340|NCT04053452|141701470|OTHER|Ulnar at forearm|Kendall's tau correlation coefficient|0.01383297|||||TWO_SIDED|95.0|-0.5288|0.5485||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.5485|-0.5288|
71096341|NCT04053452|141701470|OTHER|Ulnar at cubital fossa|Kendall's tau correlation coefficient|-0.2935683|||||TWO_SIDED|95.0|-0.6968|0.2414||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.2414|-0.6968|
71096342|NCT04053452|141701470|OTHER|Ulnar at humerus|Kendall's tau correlation coefficient|0.1067521|||||TWO_SIDED|95.0|-0.5204|0.6392||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.6392|-0.5204|
71096343|NCT04053452|141701470|OTHER|Ulnar at axilla|Kendall's tau correlation coefficient|0.0549235|||||TWO_SIDED|95.0|-0.4633|0.5594||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.5594|-0.4633|
71096344|NCT04053452|141701470|OTHER|C6|Kendall's tau correlation coefficient|-0.2597622|||||TWO_SIDED|95.0|-0.6816|0.1857||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.1857|-0.6816|
70979502|NCT01431287|141467471|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.029|STANDARD_ERROR_OF_MEAN|0.013||0.025|TWO_SIDED|95.0|0.004|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.054|0.004|0.0250
70979503|NCT01431287|141467471|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.002|STANDARD_ERROR_OF_MEAN|0.013||0.8949|TWO_SIDED|95.0|-0.023|0.027||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.027|-0.023|0.8949
70979504|NCT01431287|141467471|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.027|STANDARD_ERROR_OF_MEAN|0.013||0.0351|TWO_SIDED|95.0|0.002|0.052||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.052|0.002|0.0351
70979505|NCT01431287|141467472|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.055|0.105||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.105|0.055|<0.0001
70979506|NCT01431287|141467472|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.013||0.0002|TWO_SIDED|95.0|0.022|0.073||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.073|0.022|0.0002
70979507|NCT01431287|141467472|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.051|0.101||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.101|0.051|<0.0001
70979508|NCT01431287|141467472|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.061|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.036|0.086||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.086|0.036|<0.0001
70979509|NCT01431287|141467472|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.044|STANDARD_ERROR_OF_MEAN|0.013||0.0007|TWO_SIDED|95.0|0.018|0.069||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.069|0.018|0.0007
70979510|NCT01431287|141467472|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.004|STANDARD_ERROR_OF_MEAN|0.013||0.7755|TWO_SIDED|95.0|-0.022|0.029||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.029|-0.022|0.7755
71096345|NCT04053452|141701470|OTHER|C7|Kendall's tau correlation coefficient|-0.0129034|||||TWO_SIDED|95.0|-0.4476|0.4025||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.4025|-0.4476|
71096346|NCT04053452|141701470|OTHER|Vagus|Kendall's tau correlation coefficient|0.02457737|||||TWO_SIDED|95.0|-0.3506|0.4596||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.4596|-0.3506|
71096347|NCT04053452|141701471|OTHER|Median at wrist|Kendall's tau correlation coefficient|0.1704986|||||TWO_SIDED|95.0|-0.395|0.6584||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.6584|-0.3950|
71096348|NCT04053452|141701471|OTHER|Median at forearm|Kendall's tau correlation coefficient|0.1704986|||||TWO_SIDED|95.0|-0.395|0.6584||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.6584|-0.3950|
71096349|NCT04053452|141701471|OTHER|Median at cubital fossa|Kendall's tau correlation coefficient|0.09040847|||||TWO_SIDED|95.0|-0.3821|0.5979||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.5979|-0.3821|
71096350|NCT04053452|141701471|OTHER|Median at humerus|Kendall's tau correlation coefficient|0.02501955|||||TWO_SIDED|95.0|-0.4158|0.479||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.4790|-0.4158|
71096351|NCT04053452|141701471|OTHER|Median at axilla|Kendall's tau correlation coefficient|-0.0349215|||||TWO_SIDED|95.0|-0.5033|0.443||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.4430|-0.5033|
70979511|NCT01431287|141467472|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.039|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.090|0.039|<0.0001
70979512|NCT01431287|141467472|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.032|STANDARD_ERROR_OF_MEAN|0.013||0.0118|TWO_SIDED|95.0|0.007|0.058||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.058|0.007|0.0118
70979513|NCT01431287|141467472|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.015|STANDARD_ERROR_OF_MEAN|0.013||0.2416|TWO_SIDED|95.0|-0.01|0.04||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.040|-0.010|0.2416
70979514|NCT01431287|141467472|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.017|STANDARD_ERROR_OF_MEAN|0.013||0.1792|TWO_SIDED|95.0|-0.008|0.043||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.043|-0.008|0.1792
70979515|NCT01431287|141467473|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.074|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.125|0.074|<0.0001
70979516|NCT01431287|141467473|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.059|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.033|0.084||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.084|0.033|<0.0001
70979517|NCT01431287|141467473|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.082|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.057|0.107||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.107|0.057|<0.0001
70979518|NCT01431287|141467473|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.048|STANDARD_ERROR_OF_MEAN|0.013||0.0002|TWO_SIDED|95.0|0.023|0.073||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.073|0.023|0.0002
70979519|NCT01431287|141467473|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.041|STANDARD_ERROR_OF_MEAN|0.013||0.0014|TWO_SIDED|95.0|0.016|0.067||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.067|0.016|0.0014
70979520|NCT01431287|141467473|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.018|STANDARD_ERROR_OF_MEAN|0.013||0.1747|TWO_SIDED|95.0|-0.008|0.043||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.043|-0.008|0.1747
70979521|NCT01431287|141467473|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.04|0.091||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.091|0.040|<0.0001
70979522|NCT01431287|141467473|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.041|STANDARD_ERROR_OF_MEAN|0.013||0.0016|TWO_SIDED|95.0|0.016|0.066||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.066|0.016|0.0016
70979523|NCT01431287|141467473|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.034|STANDARD_ERROR_OF_MEAN|0.013||0.0081|TWO_SIDED|95.0|0.009|0.06||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.060|0.009|0.0081
70979524|NCT01431287|141467473|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.007|STANDARD_ERROR_OF_MEAN|0.013||0.611|TWO_SIDED|95.0|-0.019|0.032||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.032|-0.019|0.6110
70979525|NCT01431287|141467474|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.085|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.059|0.111||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.111|0.059|<0.0001
70979526|NCT01431287|141467474|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.013||0.0001|TWO_SIDED|95.0|0.025|0.076||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.076|0.025|0.0001
70979527|NCT01431287|141467474|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.077|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.051|0.102||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.102|0.051|<0.0001
70979528|NCT01431287|141467474|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.069|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.044|0.095||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.095|0.044|<0.0001
70979529|NCT01431287|141467474|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.042|STANDARD_ERROR_OF_MEAN|0.013||0.0013|TWO_SIDED|95.0|0.016|0.068||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.068|0.016|0.0013
70979530|NCT01431287|141467474|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.008|STANDARD_ERROR_OF_MEAN|0.013||0.5274|TWO_SIDED|95.0|-0.017|0.034||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.034|-0.017|0.5274
70979531|NCT01431287|141467474|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.078|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.052|0.103||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.103|0.052|<0.0001
70979532|NCT01431287|141467474|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.035|STANDARD_ERROR_OF_MEAN|0.013||0.0083|TWO_SIDED|95.0|0.009|0.06||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.060|0.009|0.0083
70979533|NCT01431287|141467474|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.007|STANDARD_ERROR_OF_MEAN|0.013||0.5744|TWO_SIDED|95.0|-0.018|0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.033|-0.018|0.5744
70979534|NCT01431287|141467474|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.027|STANDARD_ERROR_OF_MEAN|0.013||0.0381|TWO_SIDED|95.0|0.001|0.053||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.053|0.001|0.0381
70979535|NCT01431287|141467475|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.081|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.055|0.108||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.108|0.055|<0.0001
70979536|NCT01431287|141467475|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.053|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.027|0.079||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.079|0.027|<0.0001
70979537|NCT01431287|141467475|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.039|0.091||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.091|0.039|<0.0001
71035137|NCT01494532|141579182|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.017
71035138|NCT01494532|141579182|SUPERIORITY_OR_OTHER|||||||0.312|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.312
71035139|NCT01494532|141579182|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.008
71096352|NCT04053452|141701471|OTHER|Ulnar at wrist|Kendall's tau correlation coefficient|-0.0961|||||TWO_SIDED|95.0|-0.5458|0.4037||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.4037|-0.5458|
70979538|NCT01431287|141467475|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.055|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.029|0.081||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.081|0.029|<0.0001
70979539|NCT01431287|141467475|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.037|STANDARD_ERROR_OF_MEAN|0.013||0.0052|TWO_SIDED|95.0|0.011|0.063||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.063|0.011|0.0052
70979540|NCT01431287|141467475|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.016|STANDARD_ERROR_OF_MEAN|0.013||0.2273|TWO_SIDED|95.0|-0.01|0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.042|-0.010|0.2273
70979541|NCT01431287|141467475|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.045|0.097||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.097|0.045|<0.0001
70979542|NCT01431287|141467475|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.028|STANDARD_ERROR_OF_MEAN|0.013||0.033|TWO_SIDED|95.0|0.002|0.055||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.055|0.002|0.0330
70979543|NCT01431287|141467475|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.013||0.4327|TWO_SIDED|95.0|-0.016|0.037||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.037|-0.016|0.4327
70979544|NCT01431287|141467475|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.018|STANDARD_ERROR_OF_MEAN|0.013||0.1764|TWO_SIDED|95.0|-0.008|0.044||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.044|-0.008|0.1764
70979545|NCT01431287|141467476|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.056|STANDARD_ERROR_OF_MEAN|0.025||0.0241|TWO_SIDED|95.0|0.007|0.105||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.105|0.007|0.0241
70979546|NCT01431287|141467476|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.051|0.148||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.148|0.051|<0.0001
70979547|NCT01431287|141467476|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.025||0.0049|TWO_SIDED|95.0|0.021|0.119||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.119|0.021|0.0049
71035140|NCT01494532|141579182|SUPERIORITY_OR_OTHER|||||||0.659|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.659
71035141|NCT01494532|141579183|SUPERIORITY_OR_OTHER|||||||0.337|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.337
71035142|NCT01494532|141579183|SUPERIORITY_OR_OTHER|||||||0.126|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.126
71035143|NCT01494532|141579183|SUPERIORITY_OR_OTHER|||||||0.283|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.283
71096353|NCT04053452|141701471|OTHER|Ulnar at forearm|Kendall's tau correlation coefficient|-0.2239171|||||TWO_SIDED|95.0|-0.6514|0.2935||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.2935|-0.6514|
71096354|NCT04053452|141701471|OTHER|Ulnar at cubital fossa|Kendall's tau correlation coefficient|-0.0805076|||||TWO_SIDED|95.0|-0.5371|0.2974||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.2974|-0.5371|
71096355|NCT04053452|141701471|OTHER|Ulnar at humerus|Kendall's tau correlation coefficient|0.2910126|||||TWO_SIDED|95.0|-0.2791|0.7651||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.7651|-0.2791|
70979548|NCT01431287|141467476|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.147|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.098|0.196||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.196|0.098|<0.0001
70979549|NCT01431287|141467476|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.113|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.064|0.162||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.162|0.064|<0.0001
70979550|NCT01431287|141467476|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.014|STANDARD_ERROR_OF_MEAN|0.025||0.5831|TWO_SIDED|95.0|-0.063|0.035||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.035|-0.063|0.5831
70979551|NCT01431287|141467476|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.133|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.084|0.182||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.182|0.084|<0.0001
70979552|NCT01431287|141467476|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.043|STANDARD_ERROR_OF_MEAN|0.025||0.0822|TWO_SIDED|95.0|-0.092|0.006||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.006|-0.092|0.0822
70979553|NCT01431287|141467476|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.077|STANDARD_ERROR_OF_MEAN|0.025||0.002|TWO_SIDED|95.0|-0.126|-0.028||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||-0.028|-0.126|0.0020
70979554|NCT01431287|141467476|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.034|STANDARD_ERROR_OF_MEAN|0.025||0.1774|TWO_SIDED|95.0|-0.015|0.083||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.083|-0.015|0.1774
70979555|NCT01431287|141467477|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.219|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.169|0.268||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.268|0.169|<0.0001
70979556|NCT01431287|141467477|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.143|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.094|0.193||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.193|0.094|<0.0001
70979557|NCT01431287|141467477|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.209|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.16|0.258||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.258|0.160|<0.0001
70979558|NCT01431287|141467477|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.153|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.104|0.203||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.203|0.104|<0.0001
70979559|NCT01431287|141467477|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.134|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.084|0.183||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.183|0.084|<0.0001
71035144|NCT01494532|141579183|SUPERIORITY_OR_OTHER|||||||0.148|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.148
71035145|NCT01494532|141579183|SUPERIORITY_OR_OTHER|||||||0.581|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.581
71035146|NCT01494532|141579184|SUPERIORITY_OR_OTHER|||||||0.486|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.486
71035147|NCT01494532|141579184|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.026
71035148|NCT01494532|141579184|SUPERIORITY_OR_OTHER|||||||0.121|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.121
71035149|NCT01494532|141579184|SUPERIORITY_OR_OTHER|||||||0.081|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.081
71035150|NCT01494532|141579184|SUPERIORITY_OR_OTHER|||||||0.187|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.187
71035151|NCT01494532|141579185|SUPERIORITY_OR_OTHER|||||||0.134|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.134
70979560|NCT01431287|141467477|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.025||0.6974|TWO_SIDED|95.0|-0.04|0.059||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.059|-0.040|0.6974
70979561|NCT01431287|141467477|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.163|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.114|0.213||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.213|0.114|<0.0001
70979562|NCT01431287|141467477|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.025||0.0027|TWO_SIDED|95.0|0.026|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.125|0.026|0.0027
70979563|NCT01431287|141467477|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.056|STANDARD_ERROR_OF_MEAN|0.025||0.0269|TWO_SIDED|95.0|0.006|0.105||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.105|0.006|0.0269
70979564|NCT01431287|141467477|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.025||0.4343|TWO_SIDED|95.0|-0.03|0.069||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.069|-0.030|0.4343
70979565|NCT01431287|141467478|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.198|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.148|0.248||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.248|0.148|<0.0001
70979566|NCT01431287|141467478|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.146|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.096|0.197||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.197|0.096|<0.0001
70979567|NCT01431287|141467478|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.208|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.158|0.258||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.258|0.158|<0.0001
70979568|NCT01431287|141467478|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.193|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.143|0.242||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.242|0.143|<0.0001
70979569|NCT01431287|141467478|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.156|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.106|0.206||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.206|0.106|<0.0001
70979570|NCT01431287|141467478|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.025||0.698|TWO_SIDED|95.0|-0.06|0.04||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.040|-0.060|0.6980
70979571|NCT01431287|141467478|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.183|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.132|0.233||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.233|0.132|<0.0001
70979572|NCT01431287|141467478|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.051|STANDARD_ERROR_OF_MEAN|0.026||0.0442|TWO_SIDED|95.0|0.001|0.102||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.102|0.001|0.0442
71035152|NCT01494532|141579185|SUPERIORITY_OR_OTHER|||||||0.768|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.768
71096356|NCT04053452|141701471|OTHER|Ulnar at axilla|Kendall's tau correlation coefficient|0.02342428|||||TWO_SIDED|95.0|-0.4531|0.5267||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.5267|-0.4531|
71096357|NCT04053452|141701471|OTHER|C6|Kendall's tau correlation coefficient|0.06536087|||||TWO_SIDED|95.0|-0.2786|0.4454||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.4454|-0.2786|
71096358|NCT04053452|141701471|OTHER|C7|Kendall's tau correlation coefficient|0.2207792|||||TWO_SIDED|95.0|-0.2459|0.6708||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.6708|-0.2459|
70979573|NCT01431287|141467478|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.015|STANDARD_ERROR_OF_MEAN|0.026||0.5514|TWO_SIDED|95.0|-0.035|0.065||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.065|-0.035|0.5514
70979574|NCT01431287|141467478|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.036|STANDARD_ERROR_OF_MEAN|0.026||0.1569|TWO_SIDED|95.0|-0.014|0.086||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.086|-0.014|0.1569
70979575|NCT01431287|141467479|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.202|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.15|0.253||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.253|0.150|<0.0001
70979576|NCT01431287|141467479|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.183|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.132|0.234||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.234|0.132|<0.0001
71035153|NCT01494532|141579185|SUPERIORITY_OR_OTHER|||||||0.859|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.859
71035154|NCT01494532|141579185|SUPERIORITY_OR_OTHER|||||||0.903|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.903
71035155|NCT01494532|141579185|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.470
70922649|NCT04878354|141336369|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.1038|TWO_SIDED|95.0|-0.09|0.01|||Mixed Models Analysis||Tree SLIT-tablet vs. placebo SLIT-tablet, visit 6|Change from baseline (screening) to visit 6 (end of treatment). Change from baseline of log transformed concentrations is analysed in a mixed effects linear model including treatment, visit, and treatment-visit-interaction as fixed effects, log(baseline concentration) as a covariate and subject as random effect. Observed p-value.||0.01|-0.09|0.1038
70979577|NCT01431287|141467479|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.218|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.167|0.269||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.269|0.167|<0.0001
70979578|NCT01431287|141467479|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.181|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.13|0.232||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day\^interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.232|0.130|<0.0001
70979579|NCT01431287|141467479|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.199|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.148|0.25||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.250|0.148|<0.0001
70979580|NCT01431287|141467479|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.016|STANDARD_ERROR_OF_MEAN|0.026||0.5373|TWO_SIDED|95.0|-0.067|0.035||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.035|-0.067|0.5373
71035156|NCT01494532|141579186|SUPERIORITY_OR_OTHER|||||||0.822|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.822
71035157|NCT01494532|141579186|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.025
71035158|NCT01494532|141579186|SUPERIORITY_OR_OTHER|||||||0.267|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.267
71035159|NCT01494532|141579186|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.039
71035160|NCT01494532|141579186|SUPERIORITY_OR_OTHER|||||||0.458|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.458
71035161|NCT01494532|141579187|SUPERIORITY_OR_OTHER|||||||0.734|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.734
71035162|NCT01494532|141579187|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.048
71035163|NCT01494532|141579187|SUPERIORITY_OR_OTHER|||||||0.443|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.443
71035164|NCT01494532|141579187|SUPERIORITY_OR_OTHER|||||||0.123|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.123
71035165|NCT01494532|141579187|SUPERIORITY_OR_OTHER|||||||0.641|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.641
71035166|NCT01494532|141579188|SUPERIORITY_OR_OTHER|||||||0.822|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.822
71096359|NCT04053452|141701471|OTHER|Vagus|Kendall's tau correlation coefficient|0.14415|||||TWO_SIDED|95.0|-0.2333|0.4899||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.4899|-0.2333|
70979581|NCT01431287|141467479|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.165|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.114|0.216||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.216|0.114|<0.0001
70979582|NCT01431287|141467479|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.019|STANDARD_ERROR_OF_MEAN|0.026||0.4763|TWO_SIDED|95.0|-0.033|0.07||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.070|-0.033|0.4763
70979583|NCT01431287|141467479|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.037|STANDARD_ERROR_OF_MEAN|0.026||0.1613|TWO_SIDED|95.0|-0.015|0.088||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.088|-0.015|0.1613
70979584|NCT01431287|141467479|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.018|STANDARD_ERROR_OF_MEAN|0.026||0.4908|TWO_SIDED|95.0|-0.069|0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.033|-0.069|0.4908
70979585|NCT01431287|141467480|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.122|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.072|0.173||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.173|0.072|<0.0001
70979586|NCT01431287|141467480|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.026||0.0154|TWO_SIDED|95.0|0.012|0.113||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.113|0.012|0.0154
70979587|NCT01431287|141467480|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.13|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.08|0.181||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.181|0.080|<0.0001
70979588|NCT01431287|141467480|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.084|STANDARD_ERROR_OF_MEAN|0.026||0.0012|TWO_SIDED|95.0|0.033|0.134||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.134|0.033|0.0012
70979589|NCT01431287|141467480|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.026||0.0061|TWO_SIDED|95.0|0.02|0.121||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.121|0.020|0.0061
70979590|NCT01431287|141467480|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.008|STANDARD_ERROR_OF_MEAN|0.026||0.7518|TWO_SIDED|95.0|-0.059|0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.042|-0.059|0.7518
70979591|NCT01431287|141467480|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.026||0.0034|TWO_SIDED|95.0|0.025|0.126||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.126|0.025|0.0034
70979592|NCT01431287|141467480|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.059|STANDARD_ERROR_OF_MEAN|0.026||0.0209|TWO_SIDED|95.0|0.009|0.11||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.110|0.009|0.0209
70979593|NCT01431287|141467480|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.026||0.0708|TWO_SIDED|95.0|-0.004|0.097||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.097|-0.004|0.0708
71035167|NCT01494532|141579188|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.025
71035168|NCT01494532|141579188|SUPERIORITY_OR_OTHER|||||||0.267|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.267
71096360|NCT04053452|141701472|OTHER|Median at wrist|Odds Ratio (OR)|0.9310743||||0.548|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.548
70979594|NCT01431287|141467480|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.013|STANDARD_ERROR_OF_MEAN|0.026||0.6148|TWO_SIDED|95.0|-0.038|0.064||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.064|-0.038|0.6148
70979595|NCT01431287|141467481|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.164|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.114|0.215||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.215|0.114|<0.0001
70979596|NCT01431287|141467481|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.026||0.0064|TWO_SIDED|95.0|0.02|0.122||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.122|0.020|0.0064
70979597|NCT01431287|141467481|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.152|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.102|0.203||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.203|0.102|<0.0001
70979598|NCT01431287|141467481|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.075|STANDARD_ERROR_OF_MEAN|0.026||0.0035|TWO_SIDED|95.0|0.025|0.126||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.126|0.025|0.0035
70979599|NCT01431287|141467481|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.059|STANDARD_ERROR_OF_MEAN|0.026||0.0233|TWO_SIDED|95.0|0.008|0.109||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.109|0.008|0.0233
70979600|NCT01431287|141467481|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.026||0.6413|TWO_SIDED|95.0|-0.039|0.063||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.063|-0.039|0.6413
70979601|NCT01431287|141467481|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.088|STANDARD_ERROR_OF_MEAN|0.026||0.0007|TWO_SIDED|95.0|0.037|0.138||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.138|0.037|0.0007
70979602|NCT01431287|141467481|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.026||0.0003|TWO_SIDED|95.0|0.043|0.144||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.144|0.043|0.0003
70979603|NCT01431287|141467481|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.077|STANDARD_ERROR_OF_MEAN|0.026||0.003|TWO_SIDED|95.0|0.026|0.127||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.127|0.026|0.0030
70979604|NCT01431287|141467481|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.017|STANDARD_ERROR_OF_MEAN|0.026||0.5159|TWO_SIDED|95.0|-0.034|0.068||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.068|-0.034|0.5159
70979605|NCT01431287|141467482|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.159|0.261||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.261|0.159|<0.0001
71096361|NCT04053452|141701472|OTHER|Median at forearm|Odds Ratio (OR)|0.9310743||||0.548|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.548
70979606|NCT01431287|141467482|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.089|STANDARD_ERROR_OF_MEAN|0.026||0.0006|TWO_SIDED|95.0|0.038|0.141||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.141|0.038|0.0006
70979607|NCT01431287|141467482|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.183|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.132|0.234||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.234|0.132|<0.0001
70979608|NCT01431287|141467482|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.068|STANDARD_ERROR_OF_MEAN|0.026||0.0094|TWO_SIDED|95.0|0.017|0.119||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.119|0.017|0.0094
70979609|NCT01431287|141467482|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.062|STANDARD_ERROR_OF_MEAN|0.026||0.0174|TWO_SIDED|95.0|0.011|0.113||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.113|0.011|0.0174
70979610|NCT01431287|141467482|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.028|STANDARD_ERROR_OF_MEAN|0.026||0.2888|TWO_SIDED|95.0|-0.023|0.079||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.079|-0.023|0.2888
70979611|NCT01431287|141467482|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.095|STANDARD_ERROR_OF_MEAN|0.026||0.0003|TWO_SIDED|95.0|0.044|0.146||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.146|0.044|0.0003
70979612|NCT01431287|141467482|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.121|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.07|0.172||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.172|0.070|<0.0001
70979613|NCT01431287|141467482|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.115|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.064|0.166||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.166|0.064|<0.0001
70979614|NCT01431287|141467482|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.006|STANDARD_ERROR_OF_MEAN|0.026||0.8241|TWO_SIDED|95.0|-0.045|0.057||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.057|-0.045|0.8241
71035169|NCT01494532|141579188|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.039
71035170|NCT01494532|141579188|SUPERIORITY_OR_OTHER|||||||0.458|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.458
71035171|NCT01494532|141579189|SUPERIORITY_OR_OTHER|||||||0.814|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.814
71035172|NCT01494532|141579189|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.013
71035173|NCT01494532|141579189|SUPERIORITY_OR_OTHER|||||||0.287|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.287
71035174|NCT01494532|141579189|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.027
71035175|NCT01494532|141579189|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.390
71035176|NCT01494532|141579190|SUPERIORITY_OR_OTHER|||||||0.376|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.376
71035177|NCT01494532|141579190|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.036
71035178|NCT01494532|141579190|SUPERIORITY_OR_OTHER|||||||0.362|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.362
71035179|NCT01494532|141579190|SUPERIORITY_OR_OTHER|||||||0.089|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.089
71035180|NCT01494532|141579190|SUPERIORITY_OR_OTHER|||||||0.403|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.403
71035181|NCT01494532|141579191|SUPERIORITY_OR_OTHER|||||||0.419|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.419
71035182|NCT01494532|141579191|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.026
71035183|NCT01494532|141579191|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.230
71035184|NCT01494532|141579191|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.033
71035185|NCT01494532|141579191|SUPERIORITY_OR_OTHER|||||||0.266|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.266
70979615|NCT01431287|141467483|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.158|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.108|0.208||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.208|0.108|<0.0001
70979616|NCT01431287|141467483|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.072|STANDARD_ERROR_OF_MEAN|0.025||0.0048|TWO_SIDED|95.0|0.022|0.122||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.122|0.022|0.0048
70979617|NCT01431287|141467483|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.101|0.2||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.200|0.101|<0.0001
70979618|NCT01431287|141467483|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.103|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.053|0.152||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.152|0.053|<0.0001
70979619|NCT01431287|141467483|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.025||0.0116|TWO_SIDED|95.0|0.014|0.113||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.113|0.014|0.0116
70979620|NCT01431287|141467483|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.008|STANDARD_ERROR_OF_MEAN|0.025||0.7577|TWO_SIDED|95.0|-0.042|0.058||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom|spatial power covariance structure for within-patient errors|||0.058|-0.042|0.7577
70979621|NCT01431287|141467483|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.111|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.061|0.16||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.160|0.061|<0.0001
70979622|NCT01431287|141467483|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.086|STANDARD_ERROR_OF_MEAN|0.025||0.0007|TWO_SIDED|95.0|0.037|0.136||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.136|0.037|0.0007
71035186|NCT01494532|141579192|SUPERIORITY_OR_OTHER|||||||0.073|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.073
71035187|NCT01494532|141579192|SUPERIORITY_OR_OTHER|||||||0.996|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.996
71035188|NCT01494532|141579192|SUPERIORITY_OR_OTHER|||||||0.791|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.791
71035189|NCT01494532|141579192|SUPERIORITY_OR_OTHER|||||||0.747|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.747
71035190|NCT01494532|141579192|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.600
71035191|NCT01494532|141579193|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.007
71035192|NCT01494532|141579193|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.014
71035193|NCT01494532|141579193|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.016
71035194|NCT01494532|141579193|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.005
71035195|NCT01494532|141579193|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.008
71035196|NCT01494532|141579194|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.047
71035197|NCT01494532|141579194|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.005
71035198|NCT01494532|141579194|SUPERIORITY_OR_OTHER|||||||0.172|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.172
71035199|NCT01494532|141579194|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.034
71035200|NCT01494532|141579194|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.039
71035201|NCT01494532|141579195|SUPERIORITY_OR_OTHER|||||||0.292|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.292
71035202|NCT01494532|141579195|SUPERIORITY_OR_OTHER|||||||0.068|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.068
71035203|NCT01494532|141579195|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.170
70979623|NCT01431287|141467483|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.048|STANDARD_ERROR_OF_MEAN|0.025||0.0621|TWO_SIDED|95.0|-0.002|0.097||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.097|-0.002|0.0621
70979624|NCT01431287|141467483|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.039|STANDARD_ERROR_OF_MEAN|0.025||0.1266|TWO_SIDED|95.0|-0.011|0.089||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.089|-0.011|0.1266
70979625|NCT01431287|141467484|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.156|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.104|0.209||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.209|0.104|<0.0001
70979626|NCT01431287|141467484|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.087|STANDARD_ERROR_OF_MEAN|0.027||0.0013|TWO_SIDED|95.0|0.034|0.139||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.139|0.034|0.0013
70979627|NCT01431287|141467484|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.118|0.223||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.223|0.118|<0.0001
70979628|NCT01431287|141467484|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.102|STANDARD_ERROR_OF_MEAN|0.027||0.0001|TWO_SIDED|95.0|0.049|0.154||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.154|0.049|0.0001
70979629|NCT01431287|141467484|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.027||0.0002|TWO_SIDED|95.0|0.048|0.153||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.153|0.048|0.0002
70979630|NCT01431287|141467484|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.014|STANDARD_ERROR_OF_MEAN|0.027||0.6093|TWO_SIDED|95.0|-0.066|0.039||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.039|-0.066|0.6093
70979631|NCT01431287|141467484|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.088|STANDARD_ERROR_OF_MEAN|0.027||0.0011|TWO_SIDED|95.0|0.035|0.14||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.140|0.035|0.0011
70979632|NCT01431287|141467484|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.027||0.0095|TWO_SIDED|95.0|0.017|0.123||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.123|0.017|0.0095
71035204|NCT01494532|141579195|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.003
70979633|NCT01431287|141467484|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.069|STANDARD_ERROR_OF_MEAN|0.027||0.0108|TWO_SIDED|95.0|0.016|0.121||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.121|0.016|0.0108
71035205|NCT01494532|141579195|SUPERIORITY_OR_OTHER|||||||0.153|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.153
71035206|NCT01494532|141579196|SUPERIORITY_OR_OTHER|||||||0.409|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.409
71035207|NCT01494532|141579196|SUPERIORITY_OR_OTHER|||||||0.598|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.598
71035208|NCT01494532|141579196|SUPERIORITY_OR_OTHER|||||||0.992|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.992
71035209|NCT01494532|141579196|SUPERIORITY_OR_OTHER|||||||0.169|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.169
71035210|NCT01494532|141579196|SUPERIORITY_OR_OTHER|||||||0.348|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.348
71035211|NCT02433977|141579198|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
71035212|NCT02433977|141579199|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
71035213|NCT02433977|141579200|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
71035214|NCT02433977|141579201|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
71035215|NCT02433977|141579203|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
71035216|NCT02433977|141579205|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
71035217|NCT02433977|141579206|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
70979634|NCT01431287|141467484|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.027||0.9627|TWO_SIDED|95.0|-0.051|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.054|-0.051|0.9627
70979635|NCT01431287|141467485|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.118|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.074|0.162||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.162|0.074|<0.0001
70979636|NCT01431287|141467485|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.123|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.077|0.169||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.169|0.077|<0.0001
70979637|NCT01431287|141467485|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.022||0.0012|TWO_SIDED|95.0|0.028|0.114||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.114|0.028|0.0012
70979638|NCT01431287|141467485|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.05|0.137||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.137|0.050|<0.0001
70979639|NCT01431287|141467485|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.023||0.001|TWO_SIDED|95.0|0.031|0.121||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.121|0.031|0.0010
70979640|NCT01431287|141467485|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.023||0.0384|TWO_SIDED|95.0|0.003|0.092||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.092|0.003|0.0384
70979641|NCT01431287|141467485|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.141|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.097|0.185||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.185|0.097|<0.0001
70979642|NCT01431287|141467485|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.004|STANDARD_ERROR_OF_MEAN|0.023||0.8428|TWO_SIDED|95.0|-0.049|0.04||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.040|-0.049|0.8428
70979643|NCT01431287|141467485|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.022|STANDARD_ERROR_OF_MEAN|0.022||0.3048|TWO_SIDED|95.0|-0.065|0.02||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.020|-0.065|0.3048
70979644|NCT01431287|141467485|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.018|STANDARD_ERROR_OF_MEAN|0.023||0.4311|TWO_SIDED|95.0|-0.027|0.063||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.063|-0.027|0.4311
70979645|NCT01431287|141467486|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.098|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001|TWO_SIDED|95.0|0.057|0.139||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.139|0.057|<0.0001
70979646|NCT01431287|141467486|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.106|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.063|0.149||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.149|0.063|<0.0001
70979647|NCT01431287|141467486|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.051|STANDARD_ERROR_OF_MEAN|0.021||0.0136|TWO_SIDED|95.0|0.01|0.091||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.091|0.010|0.0136
70979648|NCT01431287|141467486|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.075|STANDARD_ERROR_OF_MEAN|0.021||0.0003|TWO_SIDED|95.0|0.035|0.116||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.116|0.035|0.0003
70979649|NCT01431287|141467486|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.059|STANDARD_ERROR_OF_MEAN|0.022||0.0065|TWO_SIDED|95.0|0.016|0.101||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.101|0.016|0.0065
70979650|NCT01431287|141467486|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.021||0.0277|TWO_SIDED|95.0|0.005|0.089||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.089|0.005|0.0277
70979651|NCT01431287|141467486|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.122|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001|TWO_SIDED|95.0|0.081|0.164||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.164|0.081|<0.0001
70979652|NCT01431287|141467486|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.008|STANDARD_ERROR_OF_MEAN|0.021||0.7116|TWO_SIDED|95.0|-0.049|0.034||Comments ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.034|-0.049|0.7116
70979653|NCT01431287|141467486|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.024|STANDARD_ERROR_OF_MEAN|0.02||0.2332|TWO_SIDED|95.0|-0.065|0.016||Comments ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.016|-0.065|0.2332
70979654|NCT01431287|141467486|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.017|STANDARD_ERROR_OF_MEAN|0.021||0.4374|TWO_SIDED|95.0|-0.025|0.059||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.059|-0.025|0.4374
70979655|NCT01431287|141467487|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.161|STANDARD_ERROR_OF_MEAN|0.043||0.0002|TWO_SIDED|95.0|0.077|0.244||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.244|0.077|0.0002
70979656|NCT01431287|141467487|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.045||0.0017|TWO_SIDED|95.0|0.053|0.228||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.228|0.053|0.0017
70979657|NCT01431287|141467487|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.128|STANDARD_ERROR_OF_MEAN|0.042||0.0022|TWO_SIDED|95.0|0.046|0.21||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.210|0.046|0.0022
71035218|NCT02433977|141579207|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
71035219|NCT00834717|141579214|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|97.86||||||90.0|92.36|103.69|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.69|92.36|
70979658|NCT01431287|141467487|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.176|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001|TWO_SIDED|95.0|0.093|0.259||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.259|0.093|<0.0001
70979659|NCT01431287|141467487|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.108|STANDARD_ERROR_OF_MEAN|0.044||0.0141|TWO_SIDED|95.0|0.022|0.194||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.194|0.022|0.0141
70979660|NCT01431287|141467487|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.032|STANDARD_ERROR_OF_MEAN|0.043||0.4581|TWO_SIDED|95.0|-0.053|0.118||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.118|-0.053|0.4581
71035220|NCT00834717|141579215|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|92.57||||||90.0|82.8|103.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.48|82.80|
71096362|NCT04053452|141701472|OTHER|Median at cubital fossa|Odds Ratio (OR)|1.23944918||||0.25|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.250
71035221|NCT00834717|141579216|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|92.95||||||90.0|83.11|103.97|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.97|83.11|
71035222|NCT02222818|141579217|NON_INFERIORITY_OR_EQUIVALENCE|In order to demonstrate that CAFRPlus is no less effective than CAFR by a non-inferiority margin of 2%, assuming a true paired difference of 6% and a standard deviation of 15% for the paired differences, a sample size of 39 subjects with paired data is required to achieve 90% statistical power using the one-sample t-test for non-inferiority, while controlling the one-sided type I error rate at 0.025.|Mean Difference (Net)|7.0|STANDARD_DEVIATION|8.7|<|0.0001|TWO_SIDED|95.86|4.5|9.5||The threshold for statistical significance was 0.0207, determined by the pre-specified alpha spending function accounting for one interim analysis.|t-test, 1 sided|||Null Hypothesis (Ho): μd ≤ -2% Alternative Hypothesis (Ha): μd \> -2% where μd is the paired difference in percent effective CRT pacing during AF between when CAFRPlus is applied and when CAFR is applied, based on subjects' paired measurements from the two cross-over follow-up periods, and -2% is the non-inferiority margin selected based upon clinical judgment.||9.5|4.5|<0.0001
71035223|NCT02222818|141579218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.0|STANDARD_DEVIATION|8.7|<|0.0001|TWO_SIDED|95.86|4.5|9.5||The threshold for statistical significance was 0.0207, determined by the pre-specified alpha spending function accounting for one interim analysis.|t-test, 1 sided|||Null Hypothesis (Ho): μd ≤ 0% Alternative Hypothesis (Ha): μd \> 0% where μd is the paired difference in percent effective CRT pacing during AF between when CAFRPlus is applied and when CAFR is applied, based on subjects' paired measurements from the two cross-over follow-up periods.||9.5|4.5|<0.0001
71035224|NCT00238615|141579279|SUPERIORITY_OR_OTHER||probability of survival at 2 years|0.72|STANDARD_DEVIATION|0.0|||TWO_SIDED|95.0|0.36|0.9||The primary endpoint of 2 year overall survival was (0.72) = 72%||||2-year overall survival (OS) Our null hypothesis was a probability of survival at 2 years of 0.30. The study was powered at 80% (with α 5% two-tailed) to detect a probability of survival at 2 years of 0.55. This would require 30 patients assuming accrual over 2 years with 1 year of additional follow-up. The probability of survival at 2 years of 0.55 is based on previous studies of neoadjuvant approaches with reported 2 year survival in the 40-60% range.||0.90|0.36|
71035225|NCT05710718|141579280|SUPERIORITY|||||||0.076|||||||paired T-test|No formal hypothesis test was planned for this pilot study. P-values are provided for exploratory purposes and are unadjusted for multiplicity.||||||0.076
71035226|NCT00772603|141579300|SUPERIORITY_OR_OTHER||Median Difference (Net)|-18.3|||=|0.003|TWO_SIDED|95.0|-30.4|-5.8||P values reported are not adjusted for multiple comparisons. To preserve the overall Type I error-rate at 0.050, a step-up Hochberg procedure was used for the pair-wise comparisons.|Wilcoxon (Mann-Whitney)|||A Wilcoxon rank-sum test was used to test the hypothesis of equal median reduction in PCH(T) from baseline between SPN-804 and placebo. The sample size of 120 patients per treatment arm provides over 95% power to detect a difference of 31% to 42% between placebo and 2400mg SPN-804 at a two-sided 0.025 level for an overall Type I error rate of 0.050.||-5.80|-30.40|=0.003
71096363|NCT04053452|141701472|OTHER|Median at humerus|Odds Ratio (OR)|0.9613236||||0.874|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.874
71096364|NCT04053452|141701472|OTHER|Median at axilla|Odds Ratio (OR)|0.9442314||||0.698|TWO_SIDED|95.0|||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.698
70979661|NCT01431287|141467487|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.208|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|0.124|0.293||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.293|0.124|<0.0001
70979662|NCT01431287|141467487|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.043||0.6335|TWO_SIDED|95.0|-0.064|0.105||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.105|-0.064|0.6335
70979663|NCT01431287|141467487|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.047|STANDARD_ERROR_OF_MEAN|0.041||0.253|TWO_SIDED|95.0|-0.129|0.034||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.034|-0.129|0.2530
70979664|NCT01431287|141467487|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.068|STANDARD_ERROR_OF_MEAN|0.043||0.1188|TWO_SIDED|95.0|-0.017|0.153||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.153|-0.017|0.1188
70979665|NCT01431287|141467488|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.137|STANDARD_ERROR_OF_MEAN|0.041||0.0008|TWO_SIDED|95.0|0.057|0.217||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.217|0.057|0.0008
70979666|NCT01431287|141467488|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.126|STANDARD_ERROR_OF_MEAN|0.043||0.0032|TWO_SIDED|95.0|0.042|0.209||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.209|0.042|0.0032
70979667|NCT01431287|141467488|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.105|STANDARD_ERROR_OF_MEAN|0.04||0.0085|TWO_SIDED|95.0|0.027|0.183||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.183|0.027|0.0085
70979668|NCT01431287|141467488|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.156|STANDARD_ERROR_OF_MEAN|0.04||0.0001|TWO_SIDED|95.0|0.077|0.235||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.235|0.077|0.0001
70979669|NCT01431287|141467488|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.042||0.0255|TWO_SIDED|95.0|0.011|0.176||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.176|0.011|0.0255
70979670|NCT01431287|141467488|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.032|STANDARD_ERROR_OF_MEAN|0.041||0.4393|TWO_SIDED|95.0|-0.049|0.113||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.113|-0.049|0.4393
70979671|NCT01431287|141467488|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.188|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.108|0.269||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.269|0.108|<0.0001
70979672|NCT01431287|141467488|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.041||0.7784|TWO_SIDED|95.0|-0.069|0.092||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.092|-0.069|0.7784
70979673|NCT01431287|141467488|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.051|STANDARD_ERROR_OF_MEAN|0.039||0.1965|TWO_SIDED|95.0|-0.129|0.026||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.026|-0.129|0.1965
71035227|NCT00772603|141579300|SUPERIORITY_OR_OTHER||Median Difference (Net)|-10.3|||=|0.078|TWO_SIDED|95.0|-22.3|1.2||P values reported are not adjusted for multiple comparisons. To preserve the overall Type I error-rate at 0.050, a step-up Hochberg procedure was used for the pair-wise comparisons.|Wilcoxon (Mann-Whitney)|||A Wilcoxon rank-sum test was used to test the hypothesis of equal median reduction in PCH(T) from baseline between SPN-804 and placebo. The sample size of 120 patients per treatment arm provides over 95% power to detect a difference of 24% to 32% between placebo and 1200mg SPN-804 at a two-sided 0.025 level for an overall Type I error rate of 0.050.||1.20|-22.30|=0.078
71096365|NCT04053452|141701472|OTHER|Ulnar at wrist|Odds Ratio (OR)|1.193941||||0.665|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.665
71096366|NCT04053452|141701472|OTHER|Ulnar at forearm|Odds Ratio (OR)|1.0524489||||0.82|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.820
71096367|NCT04053452|141701472|OTHER|Ulnar at cubital fossa|Odds Ratio (OR)|1.21669122||||0.193|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.193
70979674|NCT01431287|141467488|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.041||0.1315|TWO_SIDED|95.0|-0.019|0.144||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.144|-0.019|0.1315
70979675|NCT01431287|141467489|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.141|STANDARD_ERROR_OF_MEAN|0.56||0.0001|TWO_SIDED|95.0|-3.239|-1.043||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-1.043|-3.239|0.0001
70979676|NCT01431287|141467489|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.131|STANDARD_ERROR_OF_MEAN|0.56||0.0435|TWO_SIDED|95.0|-2.23|-0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.033|-2.230|0.0435
70979677|NCT01431287|141467489|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.528|STANDARD_ERROR_OF_MEAN|0.559||0.0063|TWO_SIDED|95.0|-2.623|-0.432||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.432|-2.623|0.0063
70979678|NCT01431287|141467489|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.517|STANDARD_ERROR_OF_MEAN|0.558||0.3545|TWO_SIDED|95.0|-1.611|0.577||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.577|-1.611|0.3545
70979679|NCT01431287|141467489|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.518|STANDARD_ERROR_OF_MEAN|0.559||0.3542|TWO_SIDED|95.0|-1.614|0.578||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.578|-1.614|0.3542
70979680|NCT01431287|141467489|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.613|STANDARD_ERROR_OF_MEAN|0.556||0.2697|TWO_SIDED|95.0|-1.702|0.476||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.476|-1.702|0.2697
71096368|NCT04053452|141701472|OTHER|Ulnar at humerus|Odds Ratio (OR)|1.2994068||||0.314|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.314
70979681|NCT01431287|141467489|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.13|STANDARD_ERROR_OF_MEAN|0.559||0.0434|TWO_SIDED|95.0|-2.227|-0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.033|-2.227|0.0434
70979682|NCT01431287|141467489|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.01|STANDARD_ERROR_OF_MEAN|0.563||0.0732|TWO_SIDED|95.0|-2.114|0.095||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.095|-2.114|0.0732
70979683|NCT01431287|141467489|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.011|STANDARD_ERROR_OF_MEAN|0.563||0.0724|TWO_SIDED|95.0|-2.114|0.092||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.092|-2.114|0.0724
71035228|NCT00772603|141579301|SUPERIORITY_OR_OTHER||Median Difference (Net)|-33.0|||=|0.003|TWO_SIDED|95.0|-33.0|-6.3||P values reported are not adjusted for multiple comparisons. To preserve the overall Type I error-rate at 0.050, a step-up Hochberg procedure was used for the pair-wise comparisons.|Wilcoxon (Mann-Whitney)|||A Wilcoxon rank-sum test was used to test the hypothesis of equal median reduction in PCH(M) from baseline between SPN-804 and placebo. The sample size of 120 patients per treatment arm provides over 95% power to detect a difference of 31% to 42% between placebo and 2400mg SPN-804 at a two-sided 0.025 level for an overall Type I error rate of 0.050.||-6.30|-33.00|=0.003
71035229|NCT00772603|141579301|SUPERIORITY_OR_OTHER||Median Difference (Net)|-3.3|||=|0.589|TWO_SIDED|95.0|-16.2|9.7||P values reported are not adjusted for multiple comparisons. To preserve the overall Type I error-rate at 0.050, a step-up Hochberg procedure was used for the pair-wise comparisons.|Wilcoxon (Mann-Whitney)|||A Wilcoxon rank-sum test was used to test the hypothesis of equal median reduction in PCH(M) from baseline between SPN-804 and placebo. The sample size of 120 patients per treatment arm provides over 95% power to detect a difference of 24% to 32% between placebo and 1200mg SPN-804 at a two-sided 0.025 level for an overall Type I error rate of 0.050.||9.70|-16.20|=0.589
71035230|NCT00772603|141579302|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.983|||=|0.018|TWO_SIDED|95.0|1.126|3.494|||Regression, Logistic|||The treatment response was analyzed using a logistic regression model with treatment group as a factor and country (or cluster), age, sex, and baseline seizure frequency per 28 days as explanatory variables.||3.494|1.126|=0.018
71096369|NCT04053452|141701472|OTHER|Ulnar at axilla|Odds Ratio (OR)|1.1015629||||0.405|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.405
71096370|NCT04053452|141701472|OTHER|C6|Odds Ratio (OR)|0.9140133||||0.389|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.389
71096371|NCT04053452|141701472|OTHER|C7|Odds Ratio (OR)|0.7982946||||0.139|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.139
71096372|NCT04053452|141701472|OTHER|Vagus|Odds Ratio (OR)|0.9330042||||0.622|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.622
70979684|NCT01431287|141467489|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.563||0.9983|TWO_SIDED|95.0|-1.102|1.104||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||1.104|-1.102|0.9983
71035231|NCT00772603|141579302|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67|||=|0.075||95.0|0.95|2.937|||Regression, Logistic|||The treatment response was analyzed using a logistic regression model with treatment group as a factor and country (or cluster), age, sex, and baseline seizure frequency per 28 days as explanatory variables.||2.937|0.950|=0.075
71035232|NCT00772603|141579303|SUPERIORITY_OR_OTHER||||||=|0.013||95.0|||||Fisher Exact|||Pairwise comparisons of OXC XR 2400mg/day vs. placebo seizure-free rates during the Treatment Phase were made by means of Fisher's exact test for the ITT population.||||=0.013
71096373|NCT04053452|141701473|OTHER|Median at wrist, 3 months|Kendall's tau correlation coefficient|0.2641183|||||TWO_SIDED|95.0|-0.2344|0.7511||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.7511|-0.2344|
71096374|NCT04053452|141701473|OTHER|Median at forearm, 3 months|Kendall's tau correlation coefficient|0.02596308|||||TWO_SIDED|95.0|-0.4859|0.5555||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.5555|-0.4859|
71096375|NCT04053452|141701473|OTHER|Median at cubital fossa, 3 months|Kendall's tau correlation coefficient|0.05162687|||||TWO_SIDED|95.0|-0.3342|0.417||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.4170|-0.3342|
71096376|NCT04053452|141701473|OTHER|Median at humerus, 3 months|Kendall's tau correlation coefficient|-0.1714461|||||TWO_SIDED|95.0|-0.6473|0.2723||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.2723|-0.6473|
71096377|NCT04053452|141701473|OTHER|Median at axilla, 3 months|Kendall's tau correlation coefficient|-0.0531775|||||TWO_SIDED|95.0|-0.583|0.4451||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.4451|-0.5830|
70979685|NCT01431287|141467490|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.852|STANDARD_ERROR_OF_MEAN|0.578||0.0014|TWO_SIDED|95.0|-2.985|-0.718||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.718|-2.985|0.0014
70979686|NCT01431287|141467490|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.444|STANDARD_ERROR_OF_MEAN|0.576||0.4413|TWO_SIDED|95.0|-1.573|0.686||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.686|-1.573|0.4413
70979687|NCT01431287|141467490|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.437|STANDARD_ERROR_OF_MEAN|0.578||0.0129|TWO_SIDED|95.0|-2.569|-0.304||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.304|-2.569|0.0129
70979688|NCT01431287|141467490|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.056|STANDARD_ERROR_OF_MEAN|0.574||0.9222|TWO_SIDED|95.0|-1.182|1.07||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||1.070|-1.182|0.9222
70979689|NCT01431287|141467490|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.029|STANDARD_ERROR_OF_MEAN|0.576||0.9602|TWO_SIDED|95.0|-1.157|1.1||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||1.100|-1.157|0.9602
70979690|NCT01431287|141467490|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.415|STANDARD_ERROR_OF_MEAN|0.57||0.4669|TWO_SIDED|95.0|-1.533|0.703||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.703|-1.533|0.4669
70979691|NCT01431287|141467490|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.471|STANDARD_ERROR_OF_MEAN|0.575||0.4126|TWO_SIDED|95.0|-1.598|0.656||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.656|-1.598|0.4126
70979692|NCT01431287|141467490|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.408|STANDARD_ERROR_OF_MEAN|0.583||0.0158|TWO_SIDED|95.0|-2.551|-0.265||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.265|-2.551|0.0158
70979693|NCT01431287|141467490|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.381|STANDARD_ERROR_OF_MEAN|0.582||0.0177|TWO_SIDED|95.0|-2.521|-0.24||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.240|-2.521|0.0177
70979694|NCT01431287|141467490|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.027|STANDARD_ERROR_OF_MEAN|0.58||0.9624|TWO_SIDED|95.0|-1.164|1.109||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||1.109|-1.164|0.9624
70979695|NCT01431287|141467491|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.595|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.329|0.862||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.862|0.329|<0.0001
70979696|NCT01431287|141467491|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.64|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.373|0.907||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.907|0.373|<0.0001
71035233|NCT00772603|141579303|SUPERIORITY_OR_OTHER||||||=|0.528||95.0|||||Fisher Exact|||Pairwise comparisons of OXC XR 1200mg/day vs. placebo seizure-free rates during the Treatment Phase were made by means of Fisher's exact test for the ITT population.||||=0.528
71035234|NCT00772603|141579304|SUPERIORITY_OR_OTHER||||||=|0.008||95.0|||||Fisher Exact|||Pairwise comparisons of OXC XR 2400mg/day vs. placebo seizure-free rates during the Maintenance Period were made by means of Fisher's exact test for the ITT population.||||=0.008
71035235|NCT00772603|141579304|SUPERIORITY_OR_OTHER||||||=|0.0546||95.0|||||Fisher Exact|||Pairwise comparisons of OXC XR 1200mg/day vs. placebo seizure-free rates during the Maintenance Period were made by means of Fisher's exact test for the ITT population.||||=0.0546
71096378|NCT04053452|141701473|OTHER|Ulnar at wrist, 3 months|Kendall's tau correlation coefficient|0.1371924|||||TWO_SIDED|95.0|-0.3592|0.6944||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.6944|-0.3592|
71096379|NCT04053452|141701473|OTHER|Ulnar at forearm, 3 months|Kendall's tau correlation coefficient|-0.0134595|||||TWO_SIDED|95.0|-0.5145|0.4627||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.4627|-0.5145|
71096380|NCT04053452|141701473|OTHER|Ulnar at cubital fossa, 3 months|Kendall's tau correlation coefficient|0.01313517|||||TWO_SIDED|95.0|-0.5056|0.4833||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.4833|-0.5056|
71096381|NCT04053452|141701473|OTHER|Ulnar at humerus, 3 months|Kendall's tau correlation coefficient|-0.1196495|||||TWO_SIDED|95.0|-0.5876|0.3467||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.3467|-0.5876|
71096382|NCT04053452|141701473|OTHER|Ulnar at axilla, 3 months|Kendall's tau correlation coefficient|0.0|||||TWO_SIDED|95.0|-0.3682|0.3885||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.3885|-0.3682|
71096383|NCT04053452|141701473|OTHER|C6, 3 months|Kendall's tau correlation coefficient|0.1194695|||||TWO_SIDED|95.0|-0.422|0.6686||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.6686|-0.4220|
71096384|NCT04053452|141701473|OTHER|C7, 3 months|Kendall's tau correlation coefficient|-0.0593456|||||TWO_SIDED|95.0|-0.5651|0.454||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.4540|-0.5651|
70979697|NCT01431287|141467491|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.423|STANDARD_ERROR_OF_MEAN|0.136||0.0019|TWO_SIDED|95.0|0.156|0.69||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.690|0.156|0.0019
70979698|NCT01431287|141467491|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.446|STANDARD_ERROR_OF_MEAN|0.136||0.0011|TWO_SIDED|95.0|0.179|0.712||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.712|0.179|0.0011
71096385|NCT04053452|141701473|OTHER|Vagus, 3 months|Kendall's tau correlation coefficient|-0.1920694|||||TWO_SIDED|95.0|-0.549|0.238||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.238|-0.5490|
71096386|NCT04053452|141701473|OTHER|Median at wrist, 6 months|Kendall's tau correlation coefficient|0.3150905|||||TWO_SIDED|||||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||||
71096387|NCT04053452|141701473|OTHER|Median at forearm, 6 months|Kendall's tau correlation coefficient|0.1203751|||||TWO_SIDED|||||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||||
71096388|NCT04053452|141701473|OTHER|Median at cubital fossa, 6 months|Kendall's tau correlation coefficient|0.2526605|||||TWO_SIDED|95.0|-0.1865|0.643||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.6430|-0.1865|
71096389|NCT04053452|141701473|OTHER|Median at humerus, 6 months|Kendall's tau correlation coefficient|-0.073601|||||TWO_SIDED|95.0|-0.5806|0.4223||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.4223|-0.5806|
71096390|NCT04053452|141701473|OTHER|Median at axilla, 6 months|Kendall's tau correlation coefficient|0.01369735|||||TWO_SIDED|95.0|-0.5619|0.5236||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.5236|-0.5619|
71096391|NCT04053452|141701473|OTHER|Ulnar at wrist, 6 months|Kendall's tau correlation coefficient|0.2685663|||||TWO_SIDED|95.0|-0.2488|0.7683||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.7683|-0.2488|
71096392|NCT04053452|141701473|OTHER|Ulnar at forearm, 6 months|Kendall's tau correlation coefficient|0.1802776|||||TWO_SIDED|95.0|-0.2573|0.6027||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.6027|-0.2573|
71096393|NCT04053452|141701473|OTHER|Ulnar at cubital fossa, 6 months|Kendall's tau correlation coefficient|0.2571327|||||TWO_SIDED|95.0|-0.2595|0.6227||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.6227|-0.2595|
71096394|NCT04053452|141701473|OTHER|Ulnar at humerus, 6 months|Kendall's tau correlation coefficient|-0.0684867|||||TWO_SIDED|95.0|-0.5757|0.3944||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.3944|-0.5757|
71096395|NCT04053452|141701473|OTHER|Ulnar at axilla, 6 months|Kendall's tau correlation coefficient|0.1929429|||||TWO_SIDED|95.0|-0.1828|0.555||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.5550|-0.1828|
71096396|NCT04053452|141701473|OTHER|C6, 6 months|Kendall's tau correlation coefficient|0.1975146|||||TWO_SIDED|95.0|-0.3557|0.7344||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.7344|-0.3557|
71096397|NCT04053452|141701473|OTHER|C7, 6 months|Kendall's tau correlation coefficient|-0.0754722|||||TWO_SIDED|95.0|-0.615|0.5083||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.5083|-0.6150|
71096398|NCT04053452|141701473|OTHER|Vagus, 6 months|Kendall's tau correlation coefficient|-0.0706753|||||TWO_SIDED|95.0|-0.5042|0.3963||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.3963|-0.5042|
71096399|NCT03338023|141701486|NON_INFERIORITY|Noninferiority of LY2963016 to Lantus® was demonstrated at the 0.4% noninferiority margin and over 80 percent power.|Mean Difference (Net)|-0.12|||||TWO_SIDED|95.0|-0.32|0.08||||||||0.08|-0.32|
71096400|NCT03338023|141701487|NON_INFERIORITY|Noninferiority of Lantus® to LY2963016 was demonstrated at the 0.4% noninferiority margin.|Mean Difference (Net)|-0.12|||||TWO_SIDED|95.0|-0.32|0.08||||||||0.08|-0.32|
70979699|NCT01431287|141467491|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.468|STANDARD_ERROR_OF_MEAN|0.136||0.0006|TWO_SIDED|95.0|0.201|0.735||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.735|0.201|0.0006
70979700|NCT01431287|141467491|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.172|STANDARD_ERROR_OF_MEAN|0.136||0.2045|TWO_SIDED|95.0|-0.094|0.438||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.438|-0.094|0.2045
70979701|NCT01431287|141467491|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.618|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.351|0.885||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.885|0.351|<0.0001
70979702|NCT01431287|141467491|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.045|STANDARD_ERROR_OF_MEAN|0.137||0.7432|TWO_SIDED|95.0|-0.313|0.223||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.223|-0.313|0.7432
70979703|NCT01431287|141467491|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.023|STANDARD_ERROR_OF_MEAN|0.136||0.8687|TWO_SIDED|95.0|-0.29|0.245||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.245|-0.290|0.8687
71035236|NCT00836004|141579307|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|99.69||||||90.0|93.88|105.85|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.85|93.88|
71035237|NCT00836004|141579308|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|96.23||||||90.0|90.62|102.19|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.19|90.62|
71035238|NCT00836004|141579309|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|97.17||||||90.0|92.14|102.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.48|92.14|
71035239|NCT00446966|141579321|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71096401|NCT03338023|141701488|SUPERIORITY||Mean Difference (Net)|-6.8||||0.191|TWO_SIDED|95.0|-17.0|3.4|||Mixed Models Analysis|||Before Morning Meal Glucose||3.4|-17.0|0.191
71096402|NCT03338023|141701488|SUPERIORITY||Mean Difference (Net)|-7.8||||0.25|TWO_SIDED|95.0|-21.2|5.5|||Mixed Models Analysis|||2 Hours After Morning Meal Glucose||5.5|-21.2|0.250
70979704|NCT01431287|141467491|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.022|STANDARD_ERROR_OF_MEAN|0.137||0.8709|TWO_SIDED|95.0|-0.29|0.246||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.246|-0.290|0.8709
70979705|NCT01431287|141467492|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.63|STANDARD_ERROR_OF_MEAN|0.137|<|0.0001|TWO_SIDED|95.0|0.362|0.898||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.898|0.362|<0.0001
71035240|NCT00859521|141579327|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|96.7||||||90.0|92.4|101.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101|92.4|
71035241|NCT00859521|141579328|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|98.4||||||90.0|96.9|100.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100|96.9|
71096403|NCT03338023|141701488|SUPERIORITY||Mean Difference (Net)|-13.1||||0.028|TWO_SIDED|95.0|-24.7|-1.5|||Mixed Models Analysis|||Before Mid-Day Meal Glucose||-1.5|-24.7|0.028
71096404|NCT03338023|141701488|SUPERIORITY||Mean Difference (Net)|-3.6||||0.599|TWO_SIDED|95.0|-16.8|9.7|||Mixed Models Analysis|||2 Hours After Mid-Day Meal Glucose||9.7|-16.8|0.599
71096405|NCT03338023|141701488|SUPERIORITY||Mean Difference (Net)|-11.0||||0.109|TWO_SIDED|95.0|-24.4|2.5|||Mixed Models Analysis|||Before Evening Meal Glucose||2.5|-24.4|0.109
71096406|NCT03338023|141701488|SUPERIORITY||Mean Difference (Net)|-5.4||||0.452|TWO_SIDED|95.0|-19.4|8.6|||Mixed Models Analysis|||Bedtime Glucose||8.6|-19.4|0.452
71096407|NCT03338023|141701488|SUPERIORITY||Mean Difference (Net)|-7.4||||0.18|TWO_SIDED|95.0|-18.3|3.5|||Mixed Models Analysis|||0300 Am Glucose||3.5|-18.3|0.180
71096408|NCT03338023|141701489|SUPERIORITY|||||||0.787|||||||Fisher Exact|||||||0.787
71096409|NCT03338023|141701490|SUPERIORITY|||||||0.201|||||||Fisher Exact|||||||0.201
71096410|NCT03338023|141701491|SUPERIORITY||Mean Difference (Net)|-0.3||||0.885|TWO_SIDED|95.0|-0.4|3.4|||Mixed Models Analysis|||||3.4|-0.4|0.885
71096411|NCT03338023|141701492|SUPERIORITY||Mean Difference (Net)|-3.5||||0.328|TWO_SIDED|95.0|-10.6|3.6|||Mixed Models Analysis|||Morning Pre-meal Standard Deviation||3.6|-10.6|0.328
70979706|NCT01431287|141467492|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.434|STANDARD_ERROR_OF_MEAN|0.137||0.0015|TWO_SIDED|95.0|0.166|0.703||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.703|0.166|0.0015
70979707|NCT01431287|141467492|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.419|STANDARD_ERROR_OF_MEAN|0.137||0.0022|TWO_SIDED|95.0|0.151|0.687||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.687|0.151|0.0022
71096412|NCT03338023|141701492|SUPERIORITY||Mean Difference (Net)|-1.7||||0.467|TWO_SIDED|95.0|-6.5|3.0|||Mixed Models Analysis|||Daily Mean Standard Deviation||3.0|-6.5|0.467
70979708|NCT01431287|141467492|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.227|STANDARD_ERROR_OF_MEAN|0.137||0.0966|TWO_SIDED|95.0|-0.041|0.495||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.495|-0.041|0.0966
70979709|NCT01431287|141467492|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.223|STANDARD_ERROR_OF_MEAN|0.137||0.1029|TWO_SIDED|95.0|-0.045|0.492||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.492|-0.045|0.1029
70979710|NCT01431287|141467492|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.211|STANDARD_ERROR_OF_MEAN|0.136||0.122|TWO_SIDED|95.0|-0.056|0.478||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.478|-0.056|0.1220
70979711|NCT01431287|141467492|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.438|STANDARD_ERROR_OF_MEAN|0.137||0.0014|TWO_SIDED|95.0|0.17|0.707||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.707|0.170|0.0014
70979712|NCT01431287|141467492|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.196|STANDARD_ERROR_OF_MEAN|0.137||0.1542|TWO_SIDED|95.0|-0.074|0.465||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.465|-0.074|0.1542
70979713|NCT01431287|141467492|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.192|STANDARD_ERROR_OF_MEAN|0.137||0.1626|TWO_SIDED|95.0|-0.077|0.461||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.461|-0.077|0.1626
70979714|NCT01431287|141467492|SUPERIORITY_OR_OTHER||djusted mean difference|0.004|STANDARD_ERROR_OF_MEAN|0.138||0.9765|TWO_SIDED|95.0|-0.265|0.274||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.274|-0.265|0.9765
70979715|NCT01431287|141467493|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.647|STANDARD_ERROR_OF_MEAN|0.142|<|0.0001|TWO_SIDED|95.0|0.37|0.925||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.925|0.370|<0.0001
70979716|NCT01431287|141467493|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.322|STANDARD_ERROR_OF_MEAN|0.141||0.0226|TWO_SIDED|95.0|0.045|0.6||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.600|0.045|0.0226
71096413|NCT03338023|141701493|SUPERIORITY||Mean Difference (Net)|-0.8||||0.09|TWO_SIDED|95.0|-1.7|0.1|||Mixed Models Analysis|||||0.1|-1.7|0.090
71096414|NCT03338023|141701494|SUPERIORITY||Mean Difference (Net)|-1.2||||0.089|TWO_SIDED|95.0|-2.6|0.2|||Mixed Models Analysis|||||0.2|-2.6|0.089
71096415|NCT03338023|141701495|SUPERIORITY||Mean Difference (Net)|-0.1||||0.77|TWO_SIDED|95.0|-0.7|0.5|||Mixed Models Analysis|||||0.5|-0.7|0.770
71096416|NCT03338023|141701496|SUPERIORITY||Mean Difference (Net)|-0.3||||0.879|TWO_SIDED|95.0|-3.9|3.3|||ANCOVA|||ITSQ Inconvenience of Regimen Transformed Score||3.3|-3.9|0.879
71096417|NCT03338023|141701496|SUPERIORITY||Mean Difference (Net)|-0.7||||0.788|TWO_SIDED|95.0|-5.9|4.5|||ANCOVA|||ITSQ Lifestyle Flexibility Transformed Score||4.5|-5.9|0.788
71096418|NCT03338023|141701496|SUPERIORITY||Mean Difference (Net)|-0.6||||0.775|TWO_SIDED|95.0|-4.5|3.3|||ANCOVA|||ITSQ Hypoglycemic Control Transformed Score||3.3|-4.5|0.775
71096419|NCT03338023|141701496|SUPERIORITY||Mean Difference (Net)|1.0||||0.681|TWO_SIDED|95.0|-3.6|5.6|||ANCOVA|||ITSQ Glycemic Control Transformed Score||5.6|-3.6|0.681
71096420|NCT03338023|141701496|SUPERIORITY||Mean Difference (Net)|0.4||||0.819|TWO_SIDED|95.0|-3.1|3.9|||ANCOVA|||ITSQ Insulin Delivery Device Satisfaction Transformed Score||3.9|-3.1|0.819
71096421|NCT03338023|141701496|SUPERIORITY||Mean Difference (Net)|-0.8||||0.605|TWO_SIDED|95.0|-3.9|2.3|||ANCOVA|||ITSQ Total Transformed Score||2.3|-3.9|0.605
71096422|NCT02734147|141701509|OTHER|||||||0.631|||||||Other|||||||0.631
71096423|NCT02734147|141701510|OTHER|||||||0.64|||||||Other|||||||0.640
71096424|NCT02734147|141701511|SUPERIORITY|||||||0.006|||||||Fisher Exact|||||||0.006
71096425|NCT02734147|141701512|SUPERIORITY|||||||0.655|||||||Fisher Exact|||||||0.655
71096426|NCT02734147|141701513|SUPERIORITY|||||||0.133|||||||Fisher Exact|||||||0.133
70979717|NCT01431287|141467493|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.371|STANDARD_ERROR_OF_MEAN|0.142||0.0089|TWO_SIDED|95.0|0.093|0.649||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.649|0.093|0.0089
71035242|NCT00859521|141579329|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|98.8||||||90.0|97.2|100.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100|97.2|
71035243|NCT02888756|141579331|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|||Analyzed for week 6, to provide statistical information for decision on execution of intracellular cytokine staining (ICS).||||0.14
71096427|NCT02734147|141701514|OTHER|||||||0.566|||||||Other|||||||0.566
71096428|NCT02734147|141701515|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
71096429|NCT05061706|141701542|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|0.77|<|0.0001|TWO_SIDED|95.0|-6.03|-3.02|||Mixed Effects Model for Repeated Measure|||||-3.02|-6.03|<0.0001
71096430|NCT05061706|141701543|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.72|-0.33|||Mixed Effects Model for Repeated Measure|||||-0.33|-0.72|<0.0001
71035244|NCT00834132|141579342|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|94.81||||||90.0|84.77|106.04|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||106.04|84.77|
71096431|NCT02864914|141701615|OTHER||Adjusted incidence rate ratio|0.77|||||TWO_SIDED|95.0|0.5|1.19|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||1.19|0.50|
71096432|NCT02864914|141701615|OTHER||Adjusted incidence rate ratio|0.55|||||TWO_SIDED|95.0|0.23|1.32|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||1.32|0.23|
71096433|NCT02864914|141701615|OTHER||Adjusted incidence rate ratio|0.86|||||TWO_SIDED|95.0|0.52|1.41|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||1.41|0.52|
71096434|NCT02864914|141701616|OTHER||Adjusted incidence rate ratio|0.54|||||TWO_SIDED|95.0|0.41|0.73|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.73|0.41|
71096435|NCT02864914|141701616|OTHER||Adjusted incidence rate ratio|0.41|||||TWO_SIDED|95.0|0.3|0.55|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.55|0.30|
71096436|NCT02864914|141701616|OTHER||Adjusted incidence rate ratio|0.69|||||TWO_SIDED|95.0|0.45|1.05|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||1.05|0.45|
71035245|NCT00834132|141579343|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.89||||||90.0|96.0|106.03|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||106.03|96.00|
71035246|NCT00834132|141579344|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|101.14||||||90.0|96.05|106.49|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||106.49|96.05|
71035247|NCT00488774|141579368|SUPERIORITY_OR_OTHER|||||||0.467|||||||Chi-squared|||||||0.467
71035248|NCT00488774|141579368|SUPERIORITY_OR_OTHER|||||||0.081|||||||Chi-squared|||||||0.081
71035249|NCT00488774|141579368|SUPERIORITY_OR_OTHER|||||||0.145|||||||Chi-squared|||||||0.145
71035250|NCT00488774|141579369|SUPERIORITY_OR_OTHER|||||||0.832|||||||Chi-squared|||||||0.832
71035251|NCT00488774|141579369|SUPERIORITY_OR_OTHER|||||||0.37|||||||Chi-squared|||||||0.370
71035252|NCT00488774|141579369|SUPERIORITY_OR_OTHER|||||||0.702|||||||Chi-squared|||||||0.702
71035253|NCT00075478|141579375|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.09|TWO_SIDED|95.0|0.3|1.1|||Regression, Cox|||Reference arm is Arm 2.||1.1|0.3|.09
71035254|NCT00075478|141579376|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.59|TWO_SIDED|95.0|0.1|3.0|||Regression, Cox|||||3.0|0.1|0.59
71035255|NCT00075478|141579377|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55||||0.06|TWO_SIDED|95.0|0.3|1.0|||Regression, Cox|||||1.0|0.3|0.06
71035256|NCT00075478|141579378|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53||||0.09|TWO_SIDED|95.0|0.3|1.1|||Regression, Cox|||||1.1|0.3|0.09
71035257|NCT00075478|141579379|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.16|TWO_SIDED|95.0|0.8|3.1|||Regression, Cox|||||3.1|0.8|0.16
71035258|NCT00075478|141579380|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.52||||0.14|TWO_SIDED|95.0|0.9|2.7|||Regression, Cox|||||2.7|0.9|0.14
71035259|NCT00075478|141579382|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.56||||0.05|TWO_SIDED|95.0|0.3|1.0|||Regression, Cox|||||1.0|0.3|0.05
71035260|NCT00462228|141579408|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for HVLT-R total recall learning scores.||||0.55
71035261|NCT00462228|141579408|SUPERIORITY_OR_OTHER|||||||1||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis:The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for HVLT-R total recall learning scores.||||1.00
71035262|NCT00462228|141579408|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for HVLT-R total recall learning scores.||||0.45
71035263|NCT00462228|141579408|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis:The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for HVLT-R total recall learning scores.||||0.43
71035264|NCT00462228|141579409|SUPERIORITY_OR_OTHER|||||||0.23||95.0||||6 week comparison,alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for HVLT-R delayed recall scores||||0.23
71035265|NCT00462228|141579409|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for HVLT-R delayed recall scores.||||0.022
71035266|NCT00462228|141579409|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for HVLT-R delayed recall scores.||||0.06
71035267|NCT00462228|141579409|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for HVLT-R delayed recall scores.||||0.027
71035268|NCT00462228|141579410|SUPERIORITY_OR_OTHER|||||||1||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the Trail Making Test Part A.||||1.0
71035269|NCT00462228|141579410|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the Trail Making Test Part A.||||0.55
71035270|NCT00462228|141579410|SUPERIORITY_OR_OTHER|||||||0.81||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the Trail Making Test Part A.||||0.81
71035271|NCT00462228|141579410|SUPERIORITY_OR_OTHER|||||||0.57||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the Trail Making Test Part A.||||0.57
71035272|NCT00462228|141579411|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the Trail Making Test Part B.||||0.55
71035273|NCT00462228|141579411|SUPERIORITY_OR_OTHER|||||||1||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the Trail Making Test Part B.||||1.0
71035274|NCT00462228|141579411|SUPERIORITY_OR_OTHER|||||||0.17||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the Trail Making Test Part B.||||0.17
71096437|NCT02864914|141701616|OTHER||Adjusted incidence rate ratio|0.41|||||TWO_SIDED|95.0|0.2|0.86|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.86|0.20|
71096438|NCT02864914|141701616|OTHER||Adjusted incidence rate ratio|0.65|||||TWO_SIDED|95.0|0.56|0.76|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.76|0.56|
71096439|NCT02864914|141701617|OTHER||Adjusted incidence rate ratio|2.19|||||TWO_SIDED|95.0|1.74|2.76|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||2.76|1.74|
71096440|NCT02864914|141701617|OTHER||Adjusted incidence rate ratio|2.78|||||TWO_SIDED|95.0|1.77|4.36|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||4.36|1.77|
71096441|NCT02864914|141701617|OTHER||Adjusted incidence rate ratio|2.14|||||TWO_SIDED|95.0|1.11|4.12|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||4.12|1.11|
71035275|NCT00462228|141579411|SUPERIORITY_OR_OTHER|||||||0.64||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the Trail Making Test Part B.||||0.64
71035276|NCT00462228|141579412|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for BVMT-R total recall scores.||||0.34
71035277|NCT00462228|141579412|SUPERIORITY_OR_OTHER|||||||1||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for BVLT-R total recall scores.||||1.0
71035278|NCT00462228|141579412|SUPERIORITY_OR_OTHER|||||||0.54||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for HVLT-R total recall scores.||||0.54
71035279|NCT00462228|141579412|SUPERIORITY_OR_OTHER|||||||0.91||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for BVLT-R total recall scores.||||0.91
71035280|NCT00462228|141579413|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for BVMT-R delayed recall scores.||||0.34
71035281|NCT00462228|141579413|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for BVMT-R delayed recall scores.||||0.55
71035282|NCT00462228|141579413|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for BVMT-R delayed recall scores.||||0.37
71035283|NCT00462228|141579413|SUPERIORITY_OR_OTHER|||||||0.95||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for BVMT-R delayed recall scores.||||0.95
71035284|NCT00462228|141579414|SUPERIORITY_OR_OTHER|||||||0.75||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the SDMT Written Score.||||0.75
71035285|NCT00462228|141579414|SUPERIORITY_OR_OTHER|||||||0.51||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the SDMT Written Score.||||0.51
71035286|NCT00462228|141579414|SUPERIORITY_OR_OTHER|||||||0.31||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the SDMT Written Score.||||0.31
70922650|NCT04878354|141336370|SUPERIORITY||Mean Difference (Final Values)|0.53|||<|0.0001|TWO_SIDED|95.0|0.48|0.57|||Mixed Models Analysis||Tree SLIT-tablet vs. placebo SLIT-tablet, visit 4|Change from baseline (screening) to visit 4 (pre-TPS). Change from baseline of log transformed concentrations is analysed in a mixed effects linear model including treatment, visit, and treatment-visit-interaction as fixed effects, log(baseline concentration) as a covariate and subject as random effect. Observed p-value.||0.57|0.48|<0.0001
70922651|NCT04878354|141336370|SUPERIORITY||Mean Difference (Final Values)|0.49|||<|0.0001|TWO_SIDED|95.0|0.45|0.53|||Mixed Models Analysis||Tree SLIT-tablet vs placebo SLIT-tablet, visit 6|Change from baseline (screening) to visit 6 (end of treatment). Change from baseline of log transformed concentrations is analysed in a mixed effects linear model including treatment, visit, and treatment-visit-interaction as fixed effects, log(baseline concentration) as a covariate and subject as random effect. Observed p-value.||0.53|0.45|<0.0001
70922652|NCT04878354|141336371|SUPERIORITY||Mean Difference (Final Values)|0.29|||<|0.0001|TWO_SIDED|95.0|0.24|0.33|||Mixed Models Analysis||Tree SLIT-tablet vs. placebo SLIT-tablet, visit 4|Change from baseline (screening) to visit 4 (pre-TPS). Change from baseline of log transformed concentrations is analyzed in a mixed effects linear model including treatment, visit, and treatment-visit-interaction as fixed effects, log(baseline concentration) as a covariate and subject as random effect. Observed p-value.||0.33|0.24|<0.0001
70922653|NCT04878354|141336371|SUPERIORITY||Mean Difference (Final Values)|0.31|||<|0.0001|TWO_SIDED|95.0|0.26|0.36|||Mixed Models Analysis||Tree SLIT-tablet vs. placebo SLIT-tablet, visit 6|Change from baseline (screening) to visit 6 (end of treatment). Change from baseline of log transformed concentrations is analysed in a mixed effects linear model including treatment, visit, and treatment-visit-interaction as fixed effects, log(baseline concentration) as a covariate and subject as random effect. Observed p-value.||0.36|0.26|<0.0001
70922654|NCT02879448|141336380|NON_INFERIORITY|The non-inferiority margin was developed based on reported rates for other devices. Therefore, the expected rate of the safety endpoint was assumed to be 15%. A non-inferiority margin of 5.8% represents a relative risk of 1.39.||||||0.0002|||||||Kaplan-Meier estimate|||"The following hypothesis was tested:~H0: p1(Amulet) - p1 (Watchman) ≥ Δ1~H1: p1(Amulet) - p1(Watchman) \< Δ1;~where Δ1 is the absolute value of the non-inferiority margin for the safety endpoint and p1 is the probability of a primary safety endpoint event."||||0.0002
70922655|NCT02879448|141336381|NON_INFERIORITY|The non-inferiority margin for this endpoint was developed based on the reported rates of ischemic stroke or systemic embolism for the Watchman. The 18-month rate of ischemic stroke or systemic embolism for the Watchman device has been reported in the literature as 4.2%. A non-inferiority margin of 3.2%, which represents a relative risk of 1.76, ensured that the rate observed was at most twice the rate expected with oral anticoagulant therapy.|||||<|0.0001|||||||Kaplan-Meier estimate|||"The following hypothesis was tested:~H0: p2(Amulet) - p2(Watchman) ≥ Δ2~H1: p2(Amulet) - p2(Watchman) \< Δ2;~where Δ2 is the absolute value of the non-inferiority margin for the effectiveness endpoint and p2 is the probability of a subject experiencing a primary effectiveness endpoint event."||||<0.0001
70922656|NCT02879448|141336382|NON_INFERIORITY|The non-inferiority margin for this endpoint was developed based on the reported closure rate for the Watchman device. The rate of device closure for the Watchman device has been reported in the literature as 95% (i.e., 5% had a residual jet \> 5mm). A non-inferiority margin of -3%, which represents a relative risk of 1.60, allows for trial to trial variability and implanter learning associated with implantation of a new device (Amulet).|||||<|0.0001|||||||Farrington Manning test|||"The following hypothesis was tested:~H0: p3(Amulet) - p3(Watchman) ≤ -Δ3~H1: p3(Amulet) - p3(Watchman) \> -Δ3;~where Δ3 is the absolute value of the non-inferiority margin and p3 is the 45-day closure probability."||||<0.0001
70922657|NCT02879448|141336383|NON_INFERIORITY|"The following hypothesis was tested:~H1: p4(Amulet) - p4(Watchman) \< 4.5%"|||||<|0.0001|||||||Kaplan-Meier estimate|||||||<0.0001
70922658|NCT02879448|141336384|SUPERIORITY|"The following hypothesis was tested:~H1: p5(Amulet) - p5(Watchman) \< 0"||||||0.3229|||||||Kaplan-Meier estimate|||||||0.3229
70922659|NCT02879448|141336385|SUPERIORITY|"The following hypothesis was tested:~H1: p1(Amulet) - p1(Watchman) \< 0"||||||0.466|||||||Kaplan-Meier estimate|||||||0.4660
70922660|NCT02879448|141336386|SUPERIORITY|"The following hypothesis was tested:~H1: p2(Amulet) - p2(Watchman) \< 0"||||||0.5017|||||||Kaplan-Meier estimate|||||||0.5017
70979718|NCT01431287|141467493|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.332|STANDARD_ERROR_OF_MEAN|0.141||0.0186|TWO_SIDED|95.0|0.056|0.609||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.609|0.056|0.0186
70922661|NCT02879448|141336387|SUPERIORITY|"The following hypothesis was tested:~H1: p3(Amulet) - p3(Watchman) \> 0"||||||0.0025|||||||Farrington Manning test|||||||0.0025
70922662|NCT03433339|141336391|SUPERIORITY||||||=|0.04||||||p-value threshold for statistical significance \<0.05|ANOVA|Mixed ANOVA model considering all available data.||||||=0.040
70922663|NCT05952076|141336408|OTHER||Adjusted mean difference|0.11||||0.6863|TWO_SIDED|95.0|-0.44|0.67|||Mixed Models Analysis|See Estimation Comments|The mixed model included treatment and visit as factors, including the interaction term, and was adjusted by baseline WAZ and baseline age (days). A random intercept for participant was included.|||0.67|-0.44|0.6863
70922664|NCT05952076|141336409|OTHER||Adjusted mean difference|109.3||||0.5567|TWO_SIDED|95.0|-259.76|478.36|||Mixed Models Analysis|See Estimation Comments|The mixed model included treatment and visit as factors, including the interaction term, and was adjusted by baseline weight (grams) and baseline age (days). A random intercept for participant was included.|||478.36|-259.76|0.5567
70922665|NCT05952076|141336410|OTHER||Adjusted mean difference|0.1||||0.7275|TWO_SIDED|95.0|-0.46|0.66|||Mixed Models Analysis|See Estimation Comments|The mixed model included treatment and visit as factors, including the interaction term, and was adjusted by baseline WAZ, baseline age (days) and study intervention compliance. A random intercept for participant was included.|||0.66|-0.46|0.7275
70922666|NCT05332340|141336427|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.683|TWO_SIDED||||||Kruskal-Wallis|||||||0.683
70979719|NCT01431287|141467493|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.046|STANDARD_ERROR_OF_MEAN|0.142||0.7441|TWO_SIDED|95.0|-0.231|0.324||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.324|-0.231|0.7441
70979720|NCT01431287|141467493|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.276|STANDARD_ERROR_OF_MEAN|0.14||0.0492|TWO_SIDED|95.0|0.001|0.551||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.551|0.001|0.0492
70979721|NCT01431287|141467493|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.608|STANDARD_ERROR_OF_MEAN|0.141|<|0.0001|TWO_SIDED|95.0|0.332|0.884||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.884|0.332|<0.0001
70979722|NCT01431287|141467493|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.325|STANDARD_ERROR_OF_MEAN|0.143||0.023|TWO_SIDED|95.0|0.045|0.605||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.605|0.045|0.0230
70979723|NCT01431287|141467493|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.039|STANDARD_ERROR_OF_MEAN|0.142||0.7855|TWO_SIDED|95.0|-0.24|0.317||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.317|-0.240|0.7855
70979724|NCT01431287|141467493|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.286|STANDARD_ERROR_OF_MEAN|0.142||0.0442|TWO_SIDED|95.0|0.007|0.564||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.564|0.007|0.0442
71096442|NCT02864914|141701617|OTHER||Adjusted incidence rate ratio|1.99|||||TWO_SIDED|95.0|1.48|2.66|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||2.66|1.48|
71096443|NCT02864914|141701618|OTHER||Adjusted incidence rate ratio|0.51|||||TWO_SIDED|95.0|0.37|0.72|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.72|0.37|
71096444|NCT02864914|141701619|OTHER||Adjusted incidence rate ratio|4.04|||||TWO_SIDED|95.0|3.46|4.71|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||4.71|3.46|
71096445|NCT02864914|141701620|OTHER||Adjusted incidence rate ratio|3.24|||||TWO_SIDED|95.0|2.81|3.74|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||3.74|2.81|
70979725|NCT00110305|141467526|SUPERIORITY_OR_OTHER||Differences in response rate|0.5||||0.92|TWO_SIDED|95.0|-10.4|11.3||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and Nucleoside/tide reverse transcriptase inhibitors (N\[t\]RTIs) used, and baseline viral load as covariate.||||11.3|-10.4|0.92
70979726|NCT00110305|141467526|SUPERIORITY_OR_OTHER||Difference in response rate|-2.3||||0.56|TWO_SIDED|95.0|-13.6|9.0||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.||||9.0|-13.6|0.56
71096446|NCT02864914|141701621|OTHER||Adjusted incidence rate ratio|0.7|||||TWO_SIDED|95.0|0.56|0.88|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.88|0.56|
71096447|NCT02864914|141701621|OTHER||Adjusted incidence rate ratio|0.5|||||TWO_SIDED|95.0|0.29|0.85|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.85|0.29|
71096448|NCT02864914|141701621|OTHER||Adjusted incidence rate ratio|0.66|||||TWO_SIDED|95.0|0.34|1.29|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||1.29|0.34|
71096449|NCT02864914|141701621|OTHER||Adjusted incidence rate ratio|0.77|||||TWO_SIDED|95.0|0.61|0.97|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.97|0.61|
71096450|NCT02864914|141701622|OTHER||Adjusted incidence rate ratio|0.53|||||TWO_SIDED|95.0|0.43|0.65|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.65|0.43|
71096451|NCT02864914|141701623|OTHER||Adjusted incidence rate ratio|4.04|||||TWO_SIDED|95.0|3.44|4.75|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||4.75|3.44|
71096452|NCT02864914|141701624|OTHER||Adjusted incidence rate ratio|3.34|||||TWO_SIDED|95.0|2.83|3.95|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||3.95|2.83|
71096453|NCT01487161|141701652|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.1249|TWO_SIDED|90.0|-1.2|0.2|||Longitudinal mixed effect model|||||0.2|-1.2|0.1249
71096454|NCT01487161|141701653|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.2002|TWO_SIDED|90.0|-1.1|0.3|||Longitudinal mixed effect model|||||0.3|-1.1|0.2002
71096455|NCT01487161|141701654|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.5541|TWO_SIDED|90.0|-0.7|0.8|||Longitudinal mixed effect model|||||0.8|-0.7|0.5541
70979727|NCT00110305|141467526|SUPERIORITY_OR_OTHER||Difference in response rate|-2.8||||0.62|TWO_SIDED|95.0|-14.0|8.4||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.||||8.4|-14.0|0.62
70979728|NCT00110305|141467526|SUPERIORITY_OR_OTHER||Difference in response rate|-1.5||||0.8|TWO_SIDED|95.0|-10.5|7.5||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.||||7.5|-10.5|0.80
70979729|NCT00110305|141467527|SUPERIORITY_OR_OTHER||Difference in response rate|-4.8||||0.45|TWO_SIDED|95.0|-17.1|7.6||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and Nucleoside/tide reverse transcriptase inhibitors (N\[t\]RTIs) used, and baseline viral load as covariate.||||7.6|-17.1|0.45
70979730|NCT00110305|141467527|SUPERIORITY_OR_OTHER||Difference in response rate|-4.8||||0.45|TWO_SIDED|95.0|-17.3|7.7||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.||||7.7|-17.3|0.45
71096456|NCT02945046|141701668|OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|1.3||0.9093|TWO_SIDED|95.0|-2.72|2.42||Threshold for significance at 0.05 level.|ANCOVA|||||2.42|-2.72|0.9093
70979731|NCT00110305|141467527|SUPERIORITY_OR_OTHER||Difference in response rate|0.0||||0.99|TWO_SIDED|95.0|-12.9|12.8||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.||||12.8|-12.9|0.99
70979732|NCT00110305|141467527|SUPERIORITY_OR_OTHER||Differences in response|2.6||||0.63|TWO_SIDED|95.0|-8.1|13.3||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.||||13.3|-8.1|0.63
70979733|NCT00110305|141467529|SUPERIORITY_OR_OTHER||Difference in response rate|-2.8||||||95.0|-14.7|9.1||||||||9.1|-14.7|
70979734|NCT00215150|141467550|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||Wilcoxon Signed Rank Test|||Results are from a Wilcoxon signed rank test on the difference from endpoint to baseline for the intent to treat sample from the open label phase of the project.||||< 0.001
70979735|NCT00215150|141467550|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|95.0|||||Kruskal-Wallis|||Results are from a Kruskal Wallis test on the ziprasidone/placebo groups from the randomization phase of the project.||||> .05
70979736|NCT01552057|141467616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.0988|TWO_SIDED|95.0|-0.7|0.06||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||0.06|-0.70|0.0988
70979737|NCT01552057|141467617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0003|TWO_SIDED|95.0|-0.76|-0.22||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-0.22|-0.76|0.0003
70979738|NCT01552057|141467618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.0012|TWO_SIDED|95.0|-0.71|-0.18||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-0.18|-0.71|0.0012
70979739|NCT01552057|141467619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.35||||0.0073|TWO_SIDED|95.0|-9.26|-1.45||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-1.45|-9.26|0.0073
70979740|NCT01552057|141467620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.34||||0.0049|TWO_SIDED|95.0|1.32|7.35||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Physical Functioning||7.35|1.32|0.0049
70979741|NCT01552057|141467620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.76||||0.0003|TWO_SIDED|95.0|3.57|11.94||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Role-Physical||11.94|3.57|0.0003
70979742|NCT01552057|141467620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.67||||0.0002|TWO_SIDED|95.0|2.76|8.59||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Bodily Pain||8.59|2.76|0.0002
70979743|NCT01552057|141467620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.25||||0.0192|TWO_SIDED|95.0|0.53|5.96||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||General Health||5.96|0.53|0.0192
71035287|NCT00462228|141579414|SUPERIORITY_OR_OTHER|||||||0.46||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the SDMT Written Score.||||0.46
70979744|NCT01552057|141467620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7||||0.0002|TWO_SIDED|95.0|3.15|10.25||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Vitality||10.25|3.15|0.0002
70979745|NCT01552057|141467620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.04||||0.0014|TWO_SIDED|95.0|2.74|11.34||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Social Functioning||11.34|2.74|0.0014
70979746|NCT01552057|141467620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.12||||0.0002|TWO_SIDED|95.0|4.41|13.83||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Role-Emotional||13.83|4.41|0.0002
70979747|NCT01552057|141467620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.91|||<|0.0001|TWO_SIDED|95.0|4.39|11.43||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Mental Health||11.43|4.39|<0.0001
70979748|NCT01552057|141467621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.85||||0.0002|TWO_SIDED|95.0|-4.32|-1.38||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-1.38|-4.32|0.0002
70979749|NCT01552057|141467622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.0029|TWO_SIDED|95.0|-2.12|-0.44||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||WPI||-0.44|-2.12|0.0029
70979750|NCT01552057|141467622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.0906|TWO_SIDED|95.0|-0.79|0.06||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Symptom Severity||0.06|-0.79|0.0906
70979751|NCT01552057|141467623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.0755|TWO_SIDED|95.0|-0.7|0.03||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Average Pain||0.03|-0.70|0.0755
70979752|NCT01552057|141467623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.0232|TWO_SIDED|95.0|-0.88|-0.06||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Worst Pain||-0.06|-0.88|0.0232
70979753|NCT01552057|141467624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.0126|TWO_SIDED|95.0|-0.99|-0.12||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Worst Pain||-0.12|-0.99|0.0126
70979754|NCT01552057|141467624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0092|TWO_SIDED|95.0|-0.87|-0.12||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Least Pain||-0.12|-0.87|0.0092
70979755|NCT01552057|141467624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0083|TWO_SIDED|95.0|-1.0|-0.15||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Pain Right Now||-0.15|-1.00|0.0083
70979756|NCT01552057|141467624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0807|TWO_SIDED|95.0|-0.98|0.06||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With General Activity||0.06|-0.98|0.0807
70979757|NCT01552057|141467624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75||||0.0057|TWO_SIDED|95.0|-1.29|-0.22||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Mood||-0.22|-1.29|0.0057
70979758|NCT01552057|141467624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.1114|TWO_SIDED|95.0|-0.84|0.09||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Walking Ability||0.09|-0.84|0.1114
71035288|NCT00462228|141579415|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the SDMT Oral Score.||||0.34
71096457|NCT02945046|141701668|OTHER||LS mean difference|-1.9|STANDARD_ERROR_OF_MEAN|1.29||0.1345|TWO_SIDED|95.0|-4.49|0.61||Threshold for significance at 0.05 level.|ANCOVA|||||0.61|-4.49|0.1345
71096458|NCT02114684|141701734|SUPERIORITY|||||||0.46|||||||Fisher Exact|||comparison of culture negative results at week 8||||0.46
71096459|NCT02114684|141701734|SUPERIORITY|||||||0.43|||||||Fisher Exact|||comparison of culture negative results at month 6||||0.43
71096460|NCT02114684|141701735|SUPERIORITY|||||||0.018|||||||Gehan-Breslow-Wilcoxon test|||||||0.018
71096461|NCT02114684|141701736|SUPERIORITY|||||||0.011|||||||Fisher Exact|||||||0.011
71096462|NCT02114684|141701737|SUPERIORITY|||||||0.01||||||There are significantly more adverse events in the active arm|Mantel Haenszel|||Comparison of the number of adverse events in the two arms, controlling for HIV status||||0.01
71096463|NCT02114684|141701737|SUPERIORITY|||||||0.45|||||||Mantel Haenszel|||Comparison of the 8-week culture conversion rates in the two arms, controlling for HIV status||||0.45
70979759|NCT01552057|141467624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.1081|TWO_SIDED|95.0|-0.94|0.09||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Normal Work||0.09|-0.94|0.1081
70979760|NCT01552057|141467624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0264|TWO_SIDED|95.0|-1.04|-0.07||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Relationships With Other People||-0.07|-1.04|0.0264
70979761|NCT01552057|141467624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.3959|TWO_SIDED|95.0|-0.81|0.32||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Sleep||0.32|-0.81|0.3959
71096464|NCT02114684|141701738|SUPERIORITY|||||||0.15|||||||Fisher Exact|||||||0.15
71096465|NCT00990769|141701739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_DEVIATION|5.0|>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Sample size calculation concluded that 20 patients in each group would have 80% power to detect a mean difference of 4 ± 4 with alpha equal to 0.05, as would be determined by a two-sample T test.||||>0.05
71096466|NCT04625972|141701742|SUPERIORITY||Relative Risk Reduction|33.31||||0.212|TWO_SIDED|95.0|-25.92|64.68|||Poisson regression||Primary Analysis Estimates are based on Poisson regression with robust variance. The model includes covariate for treatment and the log of follow-up time as an offset. Estimated RRR greater than 0% provides evidence in favor of AZD7442.|||64.68|-25.92|0.212
71096467|NCT04625972|141701742|SUPERIORITY||Relative Risk Reduction|43.28||||0.044|TWO_SIDED|95.0|1.4|67.37|||Poisson regression||Final Analysis Estimates are based on Poisson regression with robust variance. The model includes covariate for treatment and the log of follow-up time as an offset. Estimated RRR greater than 0% provides evidence in favor of AZD7442.|||67.37|1.40|0.044
71096468|NCT04625972|141701744|SUPERIORITY||Relative Risk Reduction|100.0||||0.664|ONE_SIDED|97.5|-1836.98||||Poisson regression||||||-1836.98|0.664
71096469|NCT04625972|141701745|SUPERIORITY||Relative Risk Reduction|13.9||||0.163|TWO_SIDED|95.0|-6.23|30.21|||Poisson regression|||||30.21|-6.23|0.163
71096470|NCT04625972|141701747|SUPERIORITY||Relative Risk Reduction|25.75||||0.744|TWO_SIDED|95.0|-343.53|87.57|||Poisson regression|||||87.57|-343.53|0.744
71096471|NCT02641353|141701755|OTHER||Geometric Mean Ratio|84.9|||||TWO_SIDED|90.0|77.3|93.2|||||Ratio of adjusted geometric means (Treatment B / Treatment A) expressed as a percentage.|To assess the bioavailability between the apremilast oral suspension and tablet formulation an analysis of variance (ANOVA) model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax.||93.2|77.3|
71096472|NCT02641353|141701755|OTHER||Geometric Mean Ratio|78.2|||||TWO_SIDED|90.0|71.2|86.0|||||Ratio of adjusted geometric means (Treatment C / Treatment B) expressed as a percentage.|To assess the effect of food on the PK of apremilast oral suspension formulation, an ANOVA model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax.||86.0|71.2|
71096473|NCT02641353|141701756|OTHER||Geometric Mean Ratio|87.6|||||TWO_SIDED|90.0|83.0|92.5|||||Ratio of adjusted geometric means (Treatment B / Treatment A) expressed as a percentage.|To assess the bioavailability between the apremilast oral suspension and tablet formulation an ANOVA model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t.||92.5|83.0|
71096474|NCT02641353|141701756|OTHER||Geometric Mean Ratio|115.3|||||TWO_SIDED|90.0|109.2|121.7|||||Ratio of adjusted geometric means (Treatment C / Treatment B) expressed as a percentage.|To assess the effect of food on the PK of apremilast oral suspension formulation, an ANOVA model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t.||121.7|109.2|
71096475|NCT02641353|141701757|OTHER||Geometric Mean Ratio|87.8|||||TWO_SIDED|90.0|83.2|92.6|||||Ratio of adjusted geometric means (Treatment B / Treatment A) expressed as a percentage.|To assess the bioavailability between the apremilast oral suspension and tablet formulation an ANOVA model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞.||92.6|83.2|
71096476|NCT02641353|141701757|OTHER||Geometric Mean Ratio|115.0|||||TWO_SIDED|90.0|109.0|121.7|||||Ratio of adjusted geometric means (Treatment C / Treatment B) expressed as a percentage.|To assess the effect of food on the PK of apremilast oral suspension formulation, an ANOVA model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞.||121.7|109.0|
71096477|NCT02641353|141701758|OTHER||Median Difference|0.25||||0.1508|TWO_SIDED|90.0|0.0|0.5|||Wilcoxon signed-rank test||Median difference (Treatment B - Treatment A) calculated from the Hodges-Lehmann estimate|Tmax was analyzed by nonparametric methods. The median difference and 90% confidence interval (CI) of the median difference were calculated from the Hodges-Lehrmann estimate.||0.50|0.00|0.1508
70979762|NCT01552057|141467624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.0119|TWO_SIDED|95.0|-1.18|-0.15||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Enjoyment of Life||-0.15|-1.18|0.0119
70979763|NCT01552057|141467624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.0222|TWO_SIDED|95.0|-0.96|-0.07||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Average Interference||-0.07|-0.96|0.0222
71096478|NCT02641353|141701758|OTHER||Median Difference|2.25|||<|0.0001|TWO_SIDED|90.0|1.27|3.25|||Wilcoxon signed-rank test||Median difference (Treatment C - Treatment B) calculated from the Hodges-Lehmann estimate|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||3.25|1.27|<0.0001
71096479|NCT03259308|141701765|SUPERIORITY|||||||0.027|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.027
71096480|NCT03259308|141701765|SUPERIORITY|||||||0.014|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.014
71035289|NCT00462228|141579415|SUPERIORITY_OR_OTHER|||||||0.75||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the SDMT Oral Score.||||0.75
71035290|NCT00462228|141579415|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the SDMT Oral Score.||||0.37
71035291|NCT00462228|141579415|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the SDMT Oral Score.||||0.45
71035292|NCT05099380|141579431|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the mean difference was above -5.|Least-square Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|1.86|||TWO_SIDED|95.0|-0.6|6.7|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as Test minus Control|Based on the sample size calculation using a two independent sample t test with a 2-sided type I error of 0.05, there would be enough power (i.e., 80%) for testing non-inferiority of the Test relative to the Control with 286 subjects (143 for each lens group) competing the study assuming the Test was 2 points higher than the Control.||6.7|-0.6|
71035293|NCT05099380|141579432|NON_INFERIORITY|Non-inferiority was declared if the upper bound of the 2-sided 95% confidence interval of the mean difference was below 0.05.|Least-square Mean Difference|0.008|STANDARD_ERROR_OF_MEAN|0.008|||TWO_SIDED|95.0|-0.02|0.01|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as Test minus Control|Based on the sample size calculation using a linear mixed model-based method with a 2-sided type I error of 0.05, there would be enough power (i.e., at least 80%) for testing non-inferiority of the Test relative to the Control with 16 subjects (8 for each lens group) competing the study assuming no difference between the Test and the Control.||0.01|-0.02|
71035294|NCT05099380|141579433|NON_INFERIORITY|Non-inferiority was declared if the upper bound of the 95% central posterior credible interval of proportion difference was below 0.05.|Mean Proportion Difference|0.0|STANDARD_DEVIATION|0.002|||TWO_SIDED|95.0|-0.004|0.004|||Bayesian hierarchical model||Proportion difference was calculated as Test minus Control|Based on the sample size calculation using a simulation approach and Bayesian analysis with the 95% central posterior credible interval, there would be enough power (i.e., at least 80%) for assessing non-inferiority of the Test relative to the Control with 240 subjects (120 for each lens group) competing the study assuming no difference between the Test and the Control.||0.004|-0.004|
71035295|NCT05099380|141579434|NON_INFERIORITY|Non- inferiority was declared if the upper bound of the 95% central posterior credible interval of proportion difference was below 0.1.|Mean Proportion Difference|0.0|STANDARD_DEVIATION|0.002|||TWO_SIDED|95.0|-0.004|0.004|||Bayesian hierarchical model||Proportion difference was calculated as Test minus Control|Based on the sample size calculation using a simulation approach and Bayesian analysis with the 95% central posterior credible interval, there would be enough power (i.e., at least 80%) for assessing non-inferiority of the Test relative to the Control with 140 subjects (70 for each lens group) competing the study assuming no difference between the Test and the Control.||0.004|-0.004|
71035296|NCT05099380|141579435|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the mean difference was above -5.|Least-square Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|2.35|||TWO_SIDED|95.0|-4.8|4.5|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as Test minus Control|Based on the sample size calculated for the primary endpoints (i.e., 286 subjects with 143 per lens group), assuming the Test was 2 points higher than the Control, the estimated statistical power for testing non-inferiority of the Test relative to the Control was 73% for CLUE comfort using a two independent sample t test with a 2-sided type I error of 0.05.||4.5|-4.8|
71096481|NCT03259308|141701766|SUPERIORITY|||||||0.001|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.001
71096482|NCT03259308|141701766|SUPERIORITY|||||||0.003|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.003
71096483|NCT03259308|141701767|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||<0.001
71096484|NCT03259308|141701767|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||<0.001
71096485|NCT03259308|141701768|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||<0.001
71096486|NCT03259308|141701768|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||<0.001
70979764|NCT01552057|141467625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.0113|TWO_SIDED|95.0|-0.71|-0.09||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-0.09|-0.71|0.0113
70979765|NCT01552057|141467626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.0005|TWO_SIDED|95.0|-0.94|-0.27||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-0.27|-0.94|0.0005
70979766|NCT01552057|141467627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|||<|0.0001|TWO_SIDED|95.0|-1.07|-0.37||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-0.37|-1.07|<0.0001
70979767|NCT01552057|141467628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.0226|TWO_SIDED|95.0|-0.82|-0.06||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-0.06|-0.82|0.0226
70979768|NCT01552057|141467629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.0408|TWO_SIDED|95.0|-0.74|-0.02||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||||-0.02|-0.74|0.0408
70979769|NCT05127486|141467635|SUPERIORITY||Odds Ratio (OR)|1.06||||0.695|TWO_SIDED|95.0|0.81|1.38|||pseudo likelihood-based repeated measure|||||1.38|0.81|0.695
70979770|NCT05127486|141467636|SUPERIORITY||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.89|1.56|||pseudo likelihood-based repeated measure|||||1.56|0.89|
70979771|NCT05127486|141467637|SUPERIORITY||Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|0.89|1.79|||pseudo likelihood-based repeated measure|||||1.79|0.89|
70979772|NCT05127486|141467638|SUPERIORITY||LS Mean difference|-0.37|||||TWO_SIDED|95.0|-0.82|0.09|||Mixed Models Analysis|||||0.09|-0.82|
71035297|NCT05099380|141579436|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the mean difference was above -5.|Least-square Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|2.13|||TWO_SIDED|95.0|-6.0|2.3|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as Test minus Control|Based on the sample size calculated for the primary endpoints (i.e., 286 subjects with 143 per lens group), assuming the Test was 2 points lower than the Control, the estimated statistical power for testing non-inferiority of the Test relative to the Control was 23% for CLUE handling using a two independent sample t test with a 2-sided type I error of 0.05.||2.3|-6.0|
70979773|NCT05127486|141467639|SUPERIORITY||LS Mean difference|-0.55|||||TWO_SIDED|95.0|-1.11|0.0|||Mixed Models Analysis|||||0.00|-1.11|
70979774|NCT05127486|141467640|SUPERIORITY||LS Mean difference|-0.36|||||TWO_SIDED|95.0|-0.9|0.18|||Mixed Models Analysis|||||0.18|-0.90|
70979775|NCT05127486|141467641|SUPERIORITY||LS Mean difference|-0.18|||||TWO_SIDED|95.0|-0.73|0.37|||Mixed Models Analysis|||||0.37|-0.73|
70979776|NCT05127486|141467642|SUPERIORITY||LS Mean difference|-0.49|||||TWO_SIDED|95.0|-0.86|-0.11|||Mixed Models Analysis|||||-0.11|-0.86|
70979777|NCT05127486|141467643|SUPERIORITY||LS Mean difference|4.39|STANDARD_ERROR_OF_MEAN|1.51|||TWO_SIDED|95.0|1.42|7.37|||ANCOVA|||Total score||7.37|1.42|
71096487|NCT03259308|141701769|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.002
71096488|NCT03259308|141701769|SUPERIORITY|||||||0.017|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.017
70979778|NCT05127486|141467643|SUPERIORITY||LS Mean difference|5.24|STANDARD_ERROR_OF_MEAN|1.7|||TWO_SIDED|95.0|1.9|8.58|||ANCOVA|||RF-R||8.58|1.90|
70979779|NCT05127486|141467643|SUPERIORITY||LS Mean difference|3.88|STANDARD_ERROR_OF_MEAN|1.44|||TWO_SIDED|95.0|1.06|6.71|||ANCOVA|||RF-P||6.71|1.06|
70979780|NCT05127486|141467643|SUPERIORITY||LS Mean difference|3.18|STANDARD_ERROR_OF_MEAN|1.66|||TWO_SIDED|95.0|-0.08|6.44|||ANCOVA|||EF||6.44|-0.08|
70979781|NCT05127486|141467644|SUPERIORITY||LS Mean difference|-2.43|STANDARD_ERROR_OF_MEAN|2.3|||TWO_SIDED|95.0|-6.94|2.08|||ANCOVA|||||2.08|-6.94|
70979782|NCT04971226|141467653|SUPERIORITY||Risk Difference (RD)|18.88|||<|0.001|TWO_SIDED|95.0|9.59|28.17|||Mantel Haenszel||The Estimate Value is a percentage.||The Confidence Interval are percentages.|28.17|9.59|<0.001
70979783|NCT04971226|141467685|SUPERIORITY||Risk Difference (RD)|29.55|||<|0.001|TWO_SIDED|95.0|16.91|42.18|||Mantel Haenszel||The Estimate Value is a percentage.||The Confidence Interval are percentages.|42.18|16.91|<0.001
70979784|NCT03464045|141467690|OTHER||Hazard Ratio (HR)|0.8||||0.122|TWO_SIDED|95.0|0.61|1.06|||Regression, Cox||Crude hazard ratio of empagliflozin/DPP-4i|Crude HRs were calculated using a Cox proportional hazards model with as-treated exposure (continuous exposure to the study drugs, defined as having consecutive treatment episodes separated by a grace period of 30 days, starting from index date) as the only included variable. Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes.||1.06|0.61|0.122
70979785|NCT03464045|141467690|OTHER||Hazard Ratio (HR)|0.89||||0.417|TWO_SIDED|95.0|0.67|1.18|||Regression, Cox||Base hazard ratio of empagliflozin/DPP-4i|"Base HRs were calculated using a Cox proportional hazards model by adjusting for variables unbalanced after PS matching. To be included in the Cox model, each covariate is required to have a minimum of 5 events per category level to avoid converge failure.~Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes."||1.18|0.67|0.417
70979786|NCT03464045|141467690|OTHER||Hazard Ratio (HR)|0.88||||0.376|TWO_SIDED|95.0|0.66|1.17|||Regression, Cox||Adjusted hazard ratio of empagliflozin/DPP-4i|Adjusted HRs were calculated using a Cox proportional hazards model by adjusting for variables unbalanced after PS matching, and pre-specified time-varying covariates. To be included in the Cox model, each covariate is required to have a minimum of 5 events per category level. Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes.||1.17|0.66|0.376
70979787|NCT03464045|141467691|OTHER||Hazard Ratio (HR)|0.79||||0.22|TWO_SIDED|95.0|0.55|1.15|||Regression, Cox||Crude hazard ratio of empagliflozin/DPP-4i|Crude HRs were calculated using a Cox proportional hazards model with as-treated exposure (continuous exposure to the study drugs, defined as having consecutive treatment episodes separated by a grace period of 30 days, starting from index date) as the only included variable. Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes.||1.15|0.55|0.220
70922667|NCT04143061|141336431|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in percentage of participants|6.55|||||TWO_SIDED|95.0|2.03|11.08||||||Statistical analysis for Serogroup A||11.08|2.03|
70979788|NCT03464045|141467691|OTHER||Hazard Ratio (HR)|0.91||||0.628|TWO_SIDED|95.0|0.63|1.32|||Regression, Cox||Base hazard ratio of empagliflozin/DPP-4i|"Base HRs were calculated using a Cox proportional hazards model by adjusting for variables unbalanced after PS matching. To be included in the Cox model, each covariate is required to have a minimum of 5 events per category level to avoid converge failure.~Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes."||1.32|0.63|0.628
70922668|NCT04143061|141336431|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in percentage of participants|21.67|||||TWO_SIDED|95.0|17.82|25.8||||||Statistical analysis for Serogroup C||25.80|17.82|
70922669|NCT04143061|141336431|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in percentage of participants|11.08|||||TWO_SIDED|95.0|7.43|14.89||||||Statistical analysis for Serogroup Y||14.89|7.43|
70922670|NCT04143061|141336431|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in percentage of participants|11.01|||||TWO_SIDED|95.0|7.86|14.47||||||Statistical analysis for Serogroup W||14.47|7.86|
70922671|NCT05485922|141336447|SUPERIORITY|Number of flow-stop episodes will be analysed, in a generalized linier mixed model, with subject included as a random component. Evidence of superior effect will be concluded, if the lower 95% confidence limit of the risk ratio between comparator and investigational device, is more than 1.|Risk Ratio (RR)|0.16|||<|0.05|TWO_SIDED|95.0|0.05|0.44|||Mixed Models Analysis|||||0.44|0.05|<0.05
70922672|NCT05485922|141336448|SUPERIORITY||Mean Difference (Final Values)|34.3||||0.05|TWO_SIDED|95.0|14.69|53.91||The pass criteria were based on results analysing the 2 primary endpoints in a hierarchical fashion: rejecting the H0 on the first endpoint (Residual urine at first flow-stop) before continuing to the second (Number of flow-stop episodes).|Mixed Models Analysis|||This was a superiority investigation in which the null hypothesis of the primary endpoints was to be rejected, at a 5% significance (alpha 0.05), to demonstrate the superiority of the investigational device.||53.91|14.69|0.05
70922673|NCT05485922|141336449|SUPERIORITY|The pass criteria were based on the results analysing the two primary endpoints in a hierarchical fashion: rejecting the null hypothesis on the first endpoint (Residual urine at first flow-stop) before continuing to the second (Number of flow-stop episodes).|Risk Ratio (RR)|0.16||||0.05|TWO_SIDED|95.0|0.05|0.44|||Mixed Models Analysis|||This was a superiority investigation in which the null hypothesis of the primary endpoints was to be rejected, at a 5% significance (alpha 0.05), to demonstrate the superiority of the investigational device.||0.44|0.05|0.05
70922674|NCT05485922|141336450|SUPERIORITY||Mean Difference (Final Values)|-95.69||||0.05|TWO_SIDED|95.0|-137.69|-53.7|||Mixed Models Analysis|||The intra-catheter pressure at flow stop was analysed in a general linear mixed model with subject included as a random component.||-53.70|-137.69|0.05
70922675|NCT05485922|141336451|OTHER||Mean Difference (Final Values)|1.21||||0.05|TWO_SIDED|95.0|-11.1|13.51|||Mixed Models Analysis|||||13.51|-11.10|0.05
70922676|NCT05485922|141336452|SUPERIORITY||Odds Ratio (OR)|0.26||||0.05|TWO_SIDED|95.0|0.07|0.96|||Mixed Models Analysis|||Analyzed using a generalized linear mixed model, modelling the probability of a positive outcome. Evidence of effect in favour of the MHZC was concluded if the upper 95% confidence limit (CL) of the odds ratio, O.R. was less than 1.||0.96|0.07|0.05
71008767|NCT02055976|141525252|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-81.837|STANDARD_ERROR_OF_MEAN|5.48|<|0.001|TWO_SIDED|95.0|-92.721|-70.954|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-70.954|-92.721|<0.001
71008768|NCT02055976|141525252|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-89.683|STANDARD_ERROR_OF_MEAN|5.567|<|0.001|TWO_SIDED|95.0|-100.74|-78.627|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-78.627|-100.740|<0.001
71008769|NCT02055976|141525252|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-76.747|STANDARD_ERROR_OF_MEAN|6.118|<|0.001|TWO_SIDED|95.0|-88.902|-64.593|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-64.593|-88.902|<0.001
71008770|NCT02055976|141525252|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-100.666|STANDARD_ERROR_OF_MEAN|6.098|<|0.001|TWO_SIDED|95.0|-112.781|-88.551|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-88.551|-112.781|<0.001
71008771|NCT02055976|141525252|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-109.49|STANDARD_ERROR_OF_MEAN|6.054|<|0.001|TWO_SIDED|95.0|-121.519|-97.462|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-97.462|-121.519|<0.001
71096489|NCT00694122|141701789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|277.9|STANDARD_ERROR_OF_MEAN|164.9|<|0.05|TWO_SIDED|95.0|-75.9|631.6|||t-test, 2 sided|No adjustments were made. T-test type: Paired samples t-test (df=14) was performed using 15 within subject differences.|The comparative measures was defined as (mean AUC of glargine (Lantus)) minus (mean AUC of NPH).|||631.6|-75.9|<0.05
71096490|NCT00694122|141701790|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71096491|NCT00694122|141701794|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71096492|NCT00809146|141701804|NON_INFERIORITY_OR_EQUIVALENCE|Assay sensitivity established by extensive review of lorazepam efficacy data. Noninferiority margin of 10% established by both clinical and statistical reasoning.|Risk Difference (RD)|0.1|||<|0.001|TWO_SIDED|95.0|0.04|0.16|||one-sided z statistic|||The null hypothesis of inferiority was tested with a one-sided z statistic. Sample size was estimated assuming independent proportions, 2 interim analyses, 70% control event rate; 90% power; a noninferiority margin of 10%; and a 1-sided test with type I error probability of 0.025. A sample size of 890 (445 per treatment group) was inflated by 15% (1024 subjects) to account for inadvertent repeated enrollment of the same subjects. Repeated enrollments of the same subject were not analyzed.||0.16|0.04|<0.001
70922677|NCT00894543|141336489|SUPERIORITY_OR_OTHER||||||<|0.001||||||P values from comparison of Escitalopram vs placebo in a linear model of the outcome as a function of intervention group and adjusted for race, clinical center, baseline outcome, and visit (week 4 or week 8).|Regression, Linear|Natural log transformations applied to hot flash frequencies for modeling assumptions.||Based on data from the Herbal Alternatives for Menopause (HALT) study, MsFLASH estimated that 90 women in each treatment group provide 90% power to detect a difference between drug and placebo with a 2-sided alpha of 0.025 to account for two primary outcomes of hot flash frequency and severity.||||<0.001
70922678|NCT00894543|141336493|SUPERIORITY_OR_OTHER||||||<|0.001||||||P values from comparison of Escitalopram vs placebo in a linear model of the outcome as a function of intervention group and adjusted for race, clinical center, baseline outcome, and visit (week 4 or week 8).|Regression, Linear|Natural log transformations applied to hot flash frequencies for modeling assumptions.||Based on data from the Herbal Alternatives for Menopause (HALT) study, MsFLASH estimated that 90 women in each treatment group provide 90% power to detect a difference between drug and placebo with a 2-sided alpha of 0.025 to account for two primary outcomes of hot flash frequency and severity.||||<0.001
70922679|NCT00894543|141336494|SUPERIORITY_OR_OTHER|||||||0.001|||||||Regression, Linear|||||||0.001
70922680|NCT05767437|141336511|EQUIVALENCE|effect size of 0.02, α \< 0.05, power = 0.02|Mean Difference (Net)|1.63||||0.98|TWO_SIDED|95.0|-55.79|59.05|||Mixed Models Analysis|||||59.05|-55.79|0.98
70922681|NCT05767437|141336512|EQUIVALENCE|an effect size of 0.00, α \< 0.05, power = 0.00|Mean Difference (Net)|0.0||||0.99|TWO_SIDED|95.0|-1.25|1.24|||Mixed Models Analysis|||||1.24|-1.25|0.99
70922682|NCT05767437|141336513|EQUIVALENCE|an effect size of 0.56 , α \< 0.05, power = 32.5|Mean Difference (Net)|6.71||||0.68|TWO_SIDED|95.0|-24.12|10.71|||Mixed Models Analysis|||||10.71|-24.12|0.68
70922683|NCT05767437|141336514|EQUIVALENCE|Analysis population description: patients were randomly assigned to either Group A or Group B|Mean Difference (Net)|0.2||||0.56|TWO_SIDED|95.0|-0.48|0.87|||Mixed Models Analysis|||an effect size of 0.24, α \< 0.05, power = 24.5||0.87|-0.48|0.56
70922684|NCT05767437|141336515|EQUIVALENCE|an effect size of 0.56, α \< 0.05, power = 57.9|Mean Difference (Net)|-250.35||||0.42|TWO_SIDED|95.0|-614.88|114.18||Interaction of Assessment and Group|Mixed Models Analysis|||||114.18|-614.88|0.42
70922685|NCT05767437|141336516|EQUIVALENCE|an effect size of 0.29, α \< 0.05, power = 88.9|Mean Difference (Net)|12.25||||0.45|TWO_SIDED|95.0|-18.67|43.17|||Mixed Models Analysis|||||43.17|-18.67|0.45
70922686|NCT05767437|141336517|EQUIVALENCE|an effect size of 0.18, α \< 0.05, power =6.5|mean rank (Z)|0.18||||0.67|TWO_SIDED|95.0|-0.61|0.96||MAS of Biceps|Wilcoxon (Mann-Whitney)|||||0.96|-0.61|0.67
70922687|NCT05767437|141336518|EQUIVALENCE|an effect size of 0.39, α \< 0.05, power = 16.2|Mean Difference (Net)|-6.63||||0.38|TWO_SIDED|95.0|-19.38|6.12|||t-test, 2 sided|||||6.12|-19.38|0.38
70922688|NCT05198310|141336525|SUPERIORITY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.281||0.047|TWO_SIDED|95.0|-1.13|-0.01||Analyzed using ANCOVA model with baseline value and stratification factor (≤1 vs. ≥2 classes of advanced targeted therapies) as covariates.|ANCOVA|||||-0.01|-1.13|0.0470
70922689|NCT05198310|141336525|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.282||0.2124|TWO_SIDED|95.0|-0.92|0.21||Analyzed using ANCOVA model with baseline value and stratification factor (≤1 vs. ≥2 classes of advanced targeted therapies) as covariates.|ANCOVA|||||0.21|-0.92|0.2124
70922690|NCT05198310|141336525|SUPERIORITY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.352||0.1091|TWO_SIDED|95.0|-1.28|0.13||Analyzed using ANCOVA model with baseline value and stratification factor (≤1 vs. ≥2 classes of advanced targeted therapies) as covariates.|ANCOVA|||||0.13|-1.28|0.1091
70922691|NCT05198310|141336526|SUPERIORITY|||||||0.0312|||||||t-test|||||||0.0312
70922692|NCT05198310|141336526|SUPERIORITY|||||||0.0338|||||||t-test|||||||0.0338
71096493|NCT00809146|141701805|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.7|1.34||||||||1.34|0.70|
71096494|NCT00809146|141701806|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.79|0.98||||||||0.98|0.79|
71096495|NCT00809146|141701807|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.65|0.95||||||||0.95|0.65|
70922693|NCT05198310|141336530|SUPERIORITY|||||||0.0333|||||||Fisher exact test|||||||0.0333
71096496|NCT00809146|141701808|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.74|1.56||||||All participants were included in this analysis of rate of recurrence because this is the most clinically relevant denominator, although, by definition, only participants who stopped could have recurrent seizures.||1.56|0.74|
71096497|NCT00809146|141701809|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.42|1.98||||||||1.98|0.42|
71096498|NCT00809146|141701810|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.99|||||TWO_SIDED|95.0|0.3|10.7||||||||10.70|0.30|
71096499|NCT00809146|141701812|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||t-test, 2 sided|||||||0.09
71096500|NCT00809146|141701813|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||t-test, 2 sided|||||||0.11
71096501|NCT01245062|141701832|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.31|0.64||P-value from a stratified log-rank test was adjusted for prior chemotherapy for advanced or metastatic disease and Baseline lactate dehydrogenase.|Log Rank||Investigator-Assessed PFS. HR \<1 indicates a lower risk with Trametinib compared with CT. HR from a stratified log-rank test was adjusted for prior chemotherapy for advanced or metastatic disease and Baseline lactate dehydrogenase.|||0.64|0.31|<0.0001
71096502|NCT01245062|141701832|SUPERIORITY||Hazard Ratio (HR)|0.41|||<|0.0001|TWO_SIDED|95.0|0.29|0.6||P-value from a stratified log-rank test was adjusted for prior chemotherapy for advanced or metastatic disease and Baseline lactate dehydrogenase.|Log Rank||Independent Review PFS. HR \<1 indicates a lower risk with Trametinib compared with CT. HR from a stratified log-rank test was adjusted for prior chemotherapy for advanced or metastatic disease and Baseline lactate dehydrogenase.|||0.60|0.29|<0.0001
71096503|NCT06025695|141701849|NON_INFERIORITY|Non-inferiority (NI) was to be demonstrated if the lower limit (LL) of the two-sided asymptotic standardized 95% confidence interval (CI) for the difference in seroconversion rate between the HRV PCV-free group and HRV group is greater than or equal to -10%.|Difference in seroconversion rate|-3.73|||||TWO_SIDED|95.0|-6.93|-0.55|||||The asymptotic standardized 95% CI for the difference in seroconversion rate between HRV PCV-free Group minus HRV Group is computed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of HRV PCV-free Group as compared to HRV Group in terms of seroconversion rates 1 month post-Dose 2.||-0.55|-6.93|
71096504|NCT06025695|141701850|NON_INFERIORITY|NI was to be demonstrated if the LL of the two-sided 95% CI for the ratio of anti-RV IgA Ab GMC between the HRV PCV-free group and HRV group is greater than or equal to 0.67.|GMC Ratio|0.71|||||TWO_SIDED|95.0|0.6|0.84|||||The comparison is done using the group GMC ratio (HRV PCV-free/HRV) (ANOVA model applied to the log10-transformed titers). The ANOVA model included the group as a fixed effect.|To demonstrate the non-inferiority of the HRV PCV-free Group as compared to HRV Group in terms of serum anti-RV IgA Ab concentrations 1 month post-Dose 2.||0.84|0.60|
71096505|NCT06025695|141701851|NON_INFERIORITY|NI was to be demonstrated if the LL of the two-sided asymptotic standardized 95% CI for the difference in the percentage between the HRV PCV-free group and HRV group is greater than or equal to -10%.|Difference in percentage|-6.37|||||TWO_SIDED|95.0|-10.81|-1.92|||||The asymptotic standardized 95% CI for the difference in in the percentage between HRV PCV-free Group minus HRV Group is computed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of HRV PCV-free Group as compared to HRV Group in terms of percentage of participants with anti-RV IgA antibody concentrations \>=90 U/mL 1 month post-Dose 2.||-1.92|-10.81|
71096506|NCT03834883|141701855|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|||||||0.07
71096507|NCT03834883|141701856|SUPERIORITY|||||||0.006|||||||Mixed Models Analysis|||||||0.006
71096508|NCT03834883|141701857|SUPERIORITY|||||||0.16|||||||Mixed Models Analysis|||||||0.16
71096509|NCT03834883|141701858|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||0.002
71096510|NCT03834883|141701859|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
71096511|NCT03834883|141701860|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
71096512|NCT03834883|141701862|SUPERIORITY|||||||0.015|||||||Mixed Models Analysis|||||||0.015
71096513|NCT03834883|141701863|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|||||||0.0005
71096514|NCT03834883|141701864|SUPERIORITY|||||||0.017|||||||Mixed Models Analysis|||||||0.017
71096515|NCT03834883|141701865|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||||||0.83
71096516|NCT03834883|141701866|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71096517|NCT00727064|141701886|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.||||||<0.001
71096518|NCT00727064|141701887|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.||||||<0.001
70922694|NCT05198310|141336530|SUPERIORITY|||||||0.1905|||||||Fisher exact test|||||||0.1905
70922695|NCT05198310|141336530|SUPERIORITY||Odds Ratio (OR)|2.95||||0.0716|TWO_SIDED|95.0|0.9|9.65|||Cochran-Mantel-Haenszel|||||9.65|0.90|0.0716
70922696|NCT05198310|141336530|SUPERIORITY||Odds Ratio (OR)|1.52||||0.471|TWO_SIDED|95.0|0.5|4.67|||Cochran-Mantel-Haenszel|||||4.67|0.50|0.4710
70922697|NCT05198310|141336530|SUPERIORITY||Odds Ratio (OR)|6.09||||0.0057|TWO_SIDED|95.0|1.62|22.88|||Cochran-Mantel-Haenszel|||||22.88|1.62|0.0057
70922698|NCT05198310|141336531|SUPERIORITY|||||||0.0762|||||||Fisher exact test|||||||0.0762
70922699|NCT05198310|141336531|SUPERIORITY|||||||1|||||||Fisher exact test|||||||1.000
70922700|NCT05198310|141336531|SUPERIORITY||Odds Ratio (OR)|1.67||||0.4172|TWO_SIDED|95.0|0.49|5.62|||Cochran-Mantel-Haenszel|||||5.62|0.49|0.4172
70922701|NCT05198310|141336531|SUPERIORITY||Odds Ratio (OR)|1.89||||0.3144|TWO_SIDED|95.0|0.55|6.45|||Cochran-Mantel-Haenszel|||||6.45|0.55|0.3144
70922702|NCT05198310|141336531|SUPERIORITY||Odds Ratio (OR)|0.97||||0.956|TWO_SIDED|95.0|0.28|3.39|||Cochran-Mantel-Haenszel|||||3.39|0.28|0.9560
70922703|NCT05198310|141336532|SUPERIORITY|||||||0.4667|||||||Fisher exact test|||||||0.4667
70922704|NCT05198310|141336532|SUPERIORITY|||||||1|||||||Fisher exact test|||||||1.0000
70922705|NCT05198310|141336532|SUPERIORITY||Odds Ratio (OR)|1.95||||0.5789|TWO_SIDED|95.0|0.17|22.3|||Cochran-Mantel-Haenszel|||||22.30|0.17|0.5789
71096519|NCT00727064|141701888|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.||||||0.004
71096520|NCT00727064|141701889|SUPERIORITY_OR_OTHER|||||||0.018|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.||||||0.018
71096521|NCT00727064|141701890|SUPERIORITY_OR_OTHER|||||||0.081|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.||||||0.081
71096522|NCT00727064|141701891|SUPERIORITY_OR_OTHER|||||||0.427|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.||||||0.427
70979789|NCT03464045|141467691|OTHER||Hazard Ratio (HR)|0.91||||0.632|TWO_SIDED|95.0|0.63|1.33|||Regression, Cox||Adjusted hazard ratio of empagliflozin/DPP-4i|Adjusted HRs were calculated using a Cox proportional hazards model by adjusting for variables unbalanced after PS matching, and pre-specified time-varying covariates. To be included in the Cox model, each covariate is required to have a minimum of 5 events per category level. Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes.||1.33|0.63|0.632
70979790|NCT03464045|141467692|OTHER||Hazard Ratio (HR)|0.84||||0.42|TWO_SIDED|95.0|0.54|1.29|||Regression, Cox||Crude hazard ratio of empagliflozin/DPP-4i|Crude HRs were calculated using a Cox proportional hazards model with as-treated exposure (continuous exposure to the study drugs, defined as having consecutive treatment episodes separated by a grace period of 30 days, starting from index date) as the only included variable. Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes.||1.29|0.54|0.420
70979791|NCT03464045|141467692|OTHER||Hazard Ratio (HR)|0.89||||0.606|TWO_SIDED|95.0|0.57|1.38|||Regression, Cox||Base hazard ratio of empagliflozin/DPP-4i|"Base HRs were calculated using a Cox proportional hazards model by adjusting for variables unbalanced after PS matching. To be included in the Cox model, each covariate is required to have a minimum of 5 events per category level to avoid converge failure.~Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes."||1.38|0.57|0.606
70979792|NCT03464045|141467692|OTHER||Hazard Ratio (HR)|0.89||||0.609|TWO_SIDED|95.0|0.57|1.38|||Regression, Cox||Adjusted hazard ratio of empagliflozin/DPP-4i|Adjusted HRs were calculated using a Cox proportional hazards model by adjusting for variables unbalanced after PS matching, and pre-specified time-varying covariates. To be included in the Cox model, each covariate is required to have a minimum of 5 events per category level. Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes.||1.38|0.57|0.609
70979793|NCT01262898|141467734|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-3.36|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-21.96|15.24|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 10 mg versus Placebo Day 1||15.24|-21.96|
70979794|NCT01262898|141467734|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-11.81|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-30.01|6.4|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 50 mg versus Placebo Day 1||6.40|-30.01|
70979795|NCT01262898|141467734|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-25.65|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-42.99|-8.32|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 125 mg versus Placebo Day 1||-8.32|-42.99|
70979796|NCT01262898|141467734|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.74|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-5.06|34.53|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 10 mg versus Placebo Day 28||34.53|-5.06|
70979797|NCT01262898|141467734|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.22|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-14.64|23.08|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 50 mg vs Placebo Day 28||23.08|-14.64|
71035298|NCT05099380|141579437|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the odds ratio was greater than 0.67.|Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|0.83|2.16|||Linear Mixed Model||Odds Ratio was calculated as Test over Control|"Based on the sample size calculated for the primary endpoints (i.e., 286 subjects with 143 per lens group), assuming the percentage of Excellent rating for the Test was 10% higher than the Control, the estimated statistical power for testing non-inferiority of the Test relative to the Control was 93% using a Pearson chi-square test for two proportions with a 2-sided type I error of 0.05."||2.16|0.83|
71035299|NCT05099380|141579438|SUPERIORITY|Superiority was declared if the lower bound of the 2-sided 95% confidence interval of the preference ratio was greater than 1.|Preference Ratio|2.4|||||TWO_SIDED|95.0|1.4|4.1|||Linear Mixed Model||Preference ratio was calculated as Study lens over Habitual lens within the Test lens group.|Based on the sample size calculated for the primary endpoints (i.e., 286 subjects with 143 per lens group), assuming the percentage of subjects preferring Study lens was 20% higher than preferring Habitual lens in the Test lens group, the estimated statistical power for testing superiority of the Test relative to the Habitual was 88% using a simulation approach with a 2-sided type I error of 0.05.||4.10|1.40|
71035300|NCT02294786|141579460|SUPERIORITY||Difference in Percentages|-4.8||||0.775|TWO_SIDED|95.0|-29.2|20.0|||Chi-squared|||Cycle 1-3 (up to 9 weeks)||20.0|-29.2|0.775
71035301|NCT02558491|141579491|OTHER|||||||0.045||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Primary statistical analysis was performed using the repeated measure ANOVA, with the treatment mode as within subject factor, and type of insulin treatment (pump vs. MDI) as between subject factor. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.045
70979798|NCT01262898|141467734|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.65|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-11.18|24.47|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 125 mg versus Placebo Day 28||24.47|-11.18|
70979799|NCT01262898|141467734|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-12.92|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-28.73|2.9|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|Day 28 versus Day 1 of the Placebo arm||2.90|-28.73|
71035302|NCT02558491|141579491|OTHER|||||||0.07||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Primary statistical analysis was performed using the repeated measure ANOVA, with the treatment mode as within subject factor, and type of insulin treatment (pump vs. MDI) as between subject factor. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.07
71035303|NCT02558491|141579491|OTHER|||||||0.177||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Primary statistical analysis was performed using the repeated measure ANOVA, with the treatment mode as within subject factor, and type of insulin treatment (pump vs. MDI) as between subject factor. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.177
71035304|NCT02558491|141579492|OTHER|||||||0.042||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test was used. Data were first binned (to ensure minimum count of five per bins) \& w2 statistics was used with expected counts given by standard of care. Based on achieved recruitment, moderate effect size (0.3) was detectable with 80% power, or large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.042
71035305|NCT02558491|141579492|OTHER|||||||0.276||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.276
71035306|NCT02558491|141579493|OTHER|||||||0.026||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.026
71035307|NCT02558491|141579493|OTHER|||||||0.173||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.173
71035308|NCT02558491|141579493|OTHER|||||||0.715||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.715
71035309|NCT02558491|141579494|OTHER|||||||0.036||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.036
70979800|NCT01262898|141467734|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.18|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-11.69|22.05|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|Day 28 versus Day 1 of GSK962040 10 mg arm||22.05|-11.69|
71096523|NCT00567580|141701917|SUPERIORITY||||||<|0.001||||||One-sided significance level = 0.001|Z test|||Alternative hypotheses: 10% improvement in 5-year FFP in Arm 2 and 20% improvement in Arm 3, both relative to Arm 1, which has an assumed 5-year FFP of 70%. Sample size of 1587 (529/arm) with overall one-sided 0.025 alpha provides 90% power. Interim analyses (reported here) tested at one-sided significance level of 0.001. P\<0.001 indicates comparison crossed interim efficacy boundary. See Limitations and Caveats section.||||<0.001
71096524|NCT00567580|141701917|SUPERIORITY|||||||0.003|||||||Z-test|||Alternative hypotheses: 10% improvement in 5-year FFP in Arm 2 and 20% improvement in Arm 3, both relative to Arm 1, which has an assumed 5-year FFP of 70%. Sample size of 1587 (529/arm) with overall one-sided 0.025 alpha provides 90% power. Interim analyses (reported here) tested at one-sided significance level of 0.001. P\<0.001 indicates comparison crossed interim efficacy boundary. See Limitations and Caveats section.||||0.003
71096525|NCT00567580|141701917|SUPERIORITY||||||<|0.001|||||||Z-test|||Alternative hypotheses: 10% improvement in 5-year FFP in Arm 2 and 20% improvement in Arm 3, both relative to Arm 1, which has an assumed 5-year FFP of 70%. Sample size of 1587 (529/arm) with overall one-sided 0.025 alpha provides 90% power. Interim analyses (reported here) tested at one-sided significance level of 0.001. P\<0.001 indicates comparison crossed interim efficacy boundary. See Limitations and Caveats section.||||<0.001
71096526|NCT00567580|141701918|SUPERIORITY||Hazard Ratio (HR)|0.57|||<|0.001|TWO_SIDED|97.5|0.45|0.72||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||0.72|0.45|<0.001
71096527|NCT00567580|141701918|SUPERIORITY||Hazard Ratio (HR)|0.67|||<|0.001|TWO_SIDED|97.5|0.51|0.89||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT + STAD|||0.89|0.51|<0.001
71096528|NCT00567580|141701918|SUPERIORITY||Hazard Ratio (HR)|0.39|||<|0.001|TWO_SIDED|97.5|0.3|0.51||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||0.51|0.30|<0.001
71096529|NCT00567580|141701919|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.137|TWO_SIDED|97.5|0.39|1.39||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.39|0.39|0.137
71096530|NCT00567580|141701919|SUPERIORITY||Hazard Ratio (HR)|0.39||||0.007|TWO_SIDED|97.5|0.16|0.95||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT + STAD|||0.95|0.16|0.007
71096531|NCT00567580|141701919|SUPERIORITY||Hazard Ratio (HR)|0.29|||<|0.001|TWO_SIDED|97.5|0.12|0.68||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||0.68|0.12|<0.001
71096532|NCT00567580|141701920|SUPERIORITY||Hazard Ratio (HR)|0.37||||0.01|TWO_SIDED|97.5|0.14|1.01||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.01|0.14|0.010
71096533|NCT00567580|141701920|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.177|TWO_SIDED|97.5|0.14|2.3||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT + STAD|||2.30|0.14|0.177
71096534|NCT00567580|141701920|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.001|TWO_SIDED|97.5|0.06|0.71||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||0.71|0.06|<0.001
71096535|NCT00567580|141701921|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.105|TWO_SIDED|97.5|0.49|1.22||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.22|0.49|0.105
71096536|NCT00567580|141701921|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.022|TWO_SIDED|97.5|0.36|1.06||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT + STAD|||1.06|0.36|0.022
71096537|NCT00567580|141701921|SUPERIORITY||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|97.5|0.29|0.81||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||0.81|0.29|<0.001
71096538|NCT00567580|141701922|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.137|TWO_SIDED|97.5|0.35|1.43||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.43|0.35|0.137
70922706|NCT05198310|141336532|SUPERIORITY||Odds Ratio (OR)|6.12||||0.0799|TWO_SIDED|95.0|0.62|60.1|||Cochran-Mantel-Haenszel|||||60.10|0.62|0.0799
70922707|NCT05198310|141336532|SUPERIORITY||Odds Ratio (OR)|0.28||||0.1034|TWO_SIDED|95.0|0.06|1.35|||Cochran-Mantel-Haenszel|||||1.35|0.06|0.1034
70922708|NCT03144518|141336575|SUPERIORITY||Partial Eta Squared|0.079||||0.005|TWO_SIDED|90.0|0.014|0.173||ANCOVA, controlling for pre-intervention levels|ANCOVA|ANCOVA, controlling for pre-intervention levels||VAS-Valence Scores||.173|.014|.005
70922709|NCT03144518|141336575|SUPERIORITY||Partial Eta-Squared|0.04||||0.047|TWO_SIDED|90.0|0.0|0.12|||ANCOVA|Controlling for pre-intervention scores||VAS-Arousal Scores||.120|.000|.047
70922710|NCT03144518|141336575|SUPERIORITY||Partial Eta Squared|0.096||||0.002|TWO_SIDED|90.0|0.022|0.196|||ANCOVA|Controlling for pre-intervention levels||Pictorial Scale||.196|.022|.002
70922711|NCT03144518|141336575|SUPERIORITY||Partial Eta Squared|0.002||||0.697|TWO_SIDED|90.0|0.0|0.036|||ANCOVA|Controlling for baseline levels||PANAS Positive Affect Scores||.036|.000|.697
70922712|NCT03144518|141336575|SUPERIORITY||Partial Eta Squared|0.005||||0.462|TWO_SIDED|90.0|0.0|0.053|||ANCOVA|||PANAS Negative Affect Scores||.053|.000|.462
70922713|NCT03144518|141336578|SUPERIORITY||Partial Eta Squared|0.001||||0.806|TWO_SIDED|90.0|0.0|0.031|||ANCOVA|Controlling for pre-intervention levels||||.031|.000|.806
71096539|NCT00567580|141701922|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.141|TWO_SIDED|97.5|0.3|1.54||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT + STAD|||1.54|0.30|0.141
71096540|NCT00567580|141701922|SUPERIORITY||Hazard Ratio (HR)|0.47||||0.014|TWO_SIDED|97.5|0.21|1.03||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.03|0.21|0.014
71096541|NCT00567580|141701923|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.235|TWO_SIDED|97.5|0.54|1.38||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.38|0.54|0.235
71096542|NCT00567580|141701923|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.481|TWO_SIDED|97.5|0.61|1.6||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT + STAD|||1.60|0.61|0.481
71096543|NCT00567580|141701923|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.213|TWO_SIDED|97.5|0.53|1.35||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.35|0.53|0.213
71096544|NCT00567580|141701924|SUPERIORITY||Odds Ratio (OR)|2.47|||<|0.001|TWO_SIDED|97.5|1.81|3.37||One-sided significance level = 0.025|Regression, Logistic|Model was adjusted for entry PSA level, pathology, seminal vesicle involvement, Gleason score, race, and age.|Reference level = PBRT Alone|Acute grade 2+ acute adverse events||3.37|1.81|<0.001
71096545|NCT00567580|141701924|SUPERIORITY||Odds Ratio (OR)|1.35||||0.007|TWO_SIDED|97.5|1.03|1.77||One-sided significance level = 0.025|Regression, Logistic|Model was adjusted for entry PSA level, pathology, seminal vesicle involvement, Gleason score, race, and age.|Reference level = PBRT + STAD|Acute grade 2+ acute adverse events||1.77|1.03|0.007
71096546|NCT00567580|141701924|SUPERIORITY||Odds Ratio (OR)|2.04||||0.002|TWO_SIDED|97.5|1.16|3.6||One-sided significance level = 0.025|Regression, Logistic|Univariate model was used due to the low number of events.|Reference level = PBRT Alone|Acute grade 3+ acute adverse events||3.60|1.16|0.002
71096547|NCT00567580|141701924|SUPERIORITY||Odds Ratio (OR)|1.47||||0.025|TWO_SIDED|95.0|0.975|2.27||One-sided significance level = 0.025|Regression, Logistic|Univariate model was used due to the low number of events.|Reference level = PBRT + STAD|Acute grade 3+ adverse events||2.27|0.975|0.025
70922714|NCT03144518|141336579|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.006||||0.438|TWO_SIDED|90.0|0.0|0.055|||ANCOVA|Controlling for Pre-Vaccination levels||4 Weeks A/Hong-Kong||.055|.000|.438
70922715|NCT03144518|141336579|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.004||||0.516|TWO_SIDED|90.0|0.0|0.051|||ANCOVA|controlling for pre-vaccination levels||A/Hong-Kong 16 Weeks Post-Vaccination||.051|.000|.516
70922716|NCT03144518|141336579|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.002||||0.671|TWO_SIDED|90.0|0.0|0.038|||ANCOVA|controlling for pre-vaccination levels||A/Michigan 4 weeks post-vaccination||.038|.000|.671
70922717|NCT03144518|141336579|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.0||||0.98|TWO_SIDED|90.0|0.0|0.0|||ANCOVA|Controlling for pre-vaccination levels||A/Michigan 16 weeks post-vaccination||.000|.000|.980
70922718|NCT03144518|141336579|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.007||||0.409|TWO_SIDED|90.0|0.0|0.057|||ANCOVA|Controlling for pre-vaccination levels||B/Brisbane 4 weeks post-vaccination||.057|.000|.409
70922719|NCT03144518|141336579|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.008||||0.377|TWO_SIDED|90.0|0.0|0.062|||ANCOVA|Controlling for pre-vaccination levels||B/Brisbane 16 weeks post-vaccination||.062|.000|.377
70922720|NCT03144518|141336579|SUPERIORITY||Partial Eta Squared|0.0||||0.892|TWO_SIDED|90.0|0.0|0.008|||ANCOVA|Controlling for pre-vaccination levels||B/Phuket 4 weeks post-vaccination||.008|.000|.892
70922721|NCT03144518|141336579|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.007||||0.426|TWO_SIDED|90.0|0.0|0.058|||ANCOVA|Controlling for pre-vaccination levels||||.058|.000|.426
70922722|NCT00448669|141336581|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED||||||Regression, Cox|||Safety analyses were performed in the intention-to-treat cohort. Primary safety end points included the frequency of adverse clinical or laboratory events.||||0.003
70922723|NCT00448669|141336582|SUPERIORITY_OR_OTHER_LEGACY||Efficacy|62.2||||0.03|TWO_SIDED|95.0|21.5|83.4|||Regression, Cox|||The primary efficacy end point was the difference in the rates of HIV infection between participants assigned to receive TDF-FTC and those assigned to receive placebo. The primary hypothesis was that TDF-FTC, as compared with placebo, would reduce the rate of HIV infection by at least 65%, with a predefined lower boundary for the 95% confidence interval of 10%.||83.4|21.5|0.03
70922724|NCT00448669|141336583|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.004|TWO_SIDED|95.0|1.05|1.28|||Regression, Logistic|In this univariate model with the analysis of number of condomless sex acts, our model estimates the odds of reporting no condomless sex acts.||"A logistic regression was used to estimate the odds of reporting zero condomless sex acts. The longitudinal dependent variable (number of condomless sex acts) was defined as:~Number of condomless vaginal sexual acts with both casual and main partners among those who reported having had at least one sexual partner in the previous 30 days."||1.28|1.05|0.004
70922725|NCT00448669|141336584|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79|||||||Fisher Exact|||Fisher's Exact Test was performed to test for differences between the treatment groups in terms of adherence based on pill count.||||0.79
70922726|NCT02638337|141336587|SUPERIORITY||LS Mean Difference|-21.8|||<|0.0001|TWO_SIDED|95.0|-25.7|-18.0|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||For the percentage of parabasal cells a mixed-effects model for repeated measures (MMRM) approach was used, with repeated measurements of the change from baseline as the response variable; treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||-18.0|-25.7|<0.0001
70922727|NCT02638337|141336588|SUPERIORITY||LS Mean Difference|7.2|||<|0.0001|TWO_SIDED|95.0|5.2|9.1|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||||9.1|5.2|<0.0001
70922728|NCT02638337|141336589|SUPERIORITY||LS Mean Difference|-0.72|||<|0.0001|TWO_SIDED|95.0|-0.84|-0.59|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||||-0.59|-0.84|<0.0001
70922729|NCT02638337|141336590|SUPERIORITY||Odds Ratio (OR)|2.23|||<|0.0001|TWO_SIDED|95.0|1.62|3.06|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|For the MBS of vaginal dryness a generalized estimating equations (GEE) model was used to fit a marginal proportional odds model to the longitudinal ordered categorical data, with repeated measurements of the change from baseline as the response variable; treatment, week, treatment by week interaction, and study center as fixed effects; and baseline severity of dryness modeled as a covariate.||3.06|1.62|<0.0001
70922730|NCT02638337|141336592|SUPERIORITY||LS Mean Difference|-21.6|||<|0.0001|TWO_SIDED|95.0|-25.2|-18.0|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 4||-18.0|-25.2|<0.0001
70922731|NCT02638337|141336592|SUPERIORITY||LS Mean Difference|-21.8|||<|0.0001|TWO_SIDED|95.0|-25.4|-18.1|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 8||-18.1|-25.4|<0.0001
71035310|NCT02558491|141579494|OTHER|||||||0.213||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.213
70979801|NCT01262898|141467734|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.11|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-13.13|19.36|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|Day 28 versus Day 1 of GSK962040 50 mg arm||19.36|-13.13|
70979802|NCT01262898|141467734|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|19.39|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|4.47|34.3|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|Day 28 versus Day 1 of GSK962040 125 mg arm||34.30|4.47|
70979803|NCT01262898|141467734|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.225|||||TWO_SIDED|95.0|-0.32|-0.129|||Mixed Models Analysis|||Type 1 Diabetes, Day 1|Intercept estimate was 125.45 and between participant standard deviation was 21.63|-0.129|-0.320|
70979804|NCT01262898|141467734|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.078|||||TWO_SIDED|95.0|-0.171|0.016|||Mixed Models Analysis|||Type 1 Diabetes, Day 28|Intercept estimate was 125.45 and between participant standard deviation was 21.63|0.016|-0.171|
70979805|NCT01262898|141467734|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.225|||||TWO_SIDED|95.0|-0.32|-0.129|||Mixed Models Analysis|||Type 2 Diabetes, Day 1|Intercept estimate was 113.23 and between participant standard deviation was 21.63|-0.129|-0.320|
70979806|NCT01262898|141467734|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.078||||||95.0|-0.171|0.016|||Mixed Models Analysis|||Type 2 Diabetes, Day 28|Intercept estimate was 113.23 and between participant standard deviation was 21.63|0.016|-0.171|
70979807|NCT00461175|141467792|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on a two group test of equivalence in proportions. These calculations are based on the following assumptions: 1) one sided α of 0.025; 2) power (1-β) of 0.80; 3) non-inferiority limit on hazard ratio of 2; and 4) an incidence of 0.5 and 1.0 per 1000 insertions.|Hazard Ratio (HR)|1.61|||||TWO_SIDED|95.0|0.96|2.7|||||Hazard ratio was adjusted for the following prognostic factors: age, BMI, breastfeeding at time of insertion and parity status.|The null hypothesis to be tested was: The perforation incidence ratio for LNG IUS vs. copper IUD is higher than or equal to 2.||2.70|0.96|
70979808|NCT00461175|141467792|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on a two group test of equivalence in proportions. These calculations are based on the following assumptions: 1) one sided α of 0.025; 2) power (1-β) of 0.80; 3) non-inferiority limit on hazard ratio of 2; and 4) an incidence of 0.5 and 1.0 per 1000 insertions.|Hazard Ratio (HR)|1.65|||||TWO_SIDED|95.0|0.99|2.78|||||Hazard ratio was adjusted for the following prognostic factors: age, BMI, time since last delivery, experience of the inserting health care provider.|The null hypothesis to be tested was: The perforation incidence ratio for LNG IUS vs. copper IUD is higher than or equal to 2.||2.78|0.99|
70979809|NCT00461175|141467793|SUPERIORITY_OR_OTHER||Pearl Index|0.06|||||TWO_SIDED|95.0|0.04|0.09||||||||0.09|0.04|
70979810|NCT00461175|141467793|SUPERIORITY_OR_OTHER||Pearl Index|0.52|||||TWO_SIDED|95.0|0.42|0.64||||||||0.64|0.42|
70979811|NCT00461175|141467793|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.16|||||TWO_SIDED|95.0|0.1|0.25|||||Hazard ratio was adjusted for the following prognostic factors: age, BMI, and parity.|||0.25|0.10|
70979812|NCT00327444|141467799|SUPERIORITY_OR_OTHER||Least squares (LS) Mean difference|31.8|STANDARD_ERROR_OF_MEAN|10.59||0.0019|TWO_SIDED|95.0|10.56|53.05||Estimated using Wilcoxon rank-sum test with stratification of baseline paracentesis (=\<2 weeks versus \>2 weeks) at randomization.|ANOVA|Estimated from ANOVA model with stratification of baseline paracentesis (=\<2 weeks versus \>2 weeks).|The LS mean difference is estimated for aflibercept versus placebo (aflibercept-placebo).|||53.05|10.56|0.0019
70979813|NCT00327444|141467800|SUPERIORITY_OR_OTHER||Least squares (LS) Mean difference|375.5|STANDARD_ERROR_OF_MEAN|205.99||0.016|TWO_SIDED|95.0|-46.48|797.42||Estimated using Wilcoxon rank-sum test with stratification of baseline paracentesis (=\<2 weeks versus \>2 weeks) at randomization.|ANOVA|Estimated from ANOVA model with stratification of baseline paracentesis (=\<2 weeks versus \>2 weeks).|The LS mean difference was estimated for aflibercept versus placebo (aflibercept-placebo).|||797.42|-46.48|0.0160
70979814|NCT00327444|141467801|SUPERIORITY_OR_OTHER||Least squares (LS) Mean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.94||0.0035|TWO_SIDED|95.0|-4.33|-0.54||Estimated using Wilcoxon rank-sum test with stratification of baseline paracentesis (=\<2 weeks versus \>2 weeks) at randomization.|ANOVA|Estimated from ANOVA model with stratification of baseline paracentesis (=\<2 weeks versus \>2 weeks).|The LS mean difference is estimated for aflibercept versus placebo (aflibercept-placebo).|||-0.54|-4.33|0.0035
70979815|NCT00552110|141467806|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Multiplicity for multiple treatment comparisons was not adjusted.|ANCOVA|Analysis of Covariance (ANCOVA); classification variables: treatment, center, dosing sequence (stratification variable); covariate: baseline score||"Null hypothesis: the concurrent administration of MFNS and OXY once daily has the same mean change from baseline in AM/PM NOW TNSS as that of OXY twice daily.~Power calculation: The target randomization of 875 subjects (175 subjects per treatment arm) was needed to detect a treatment difference of 0.8 point or more in change from baseline in AM/PM NOW TNSS, with a two-sided alpha of 0.05 and 90% power, assuming a pooled standard deviation of 2.3 points."||||0.002
70979816|NCT00552110|141467806|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||Null hypothesis: the concurrent administration of MFNS and OXY once daily has the same mean change from baseline in AM/PM NOW TNSS as that of OXY twice daily.||||<0.001
70979817|NCT00552110|141467806|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||Null hypothesis: the administration of MFNS once daily has the same mean change from baseline in AM/PM NOW TNSS as that of placebo.||||<0.001
70979818|NCT00552110|141467807|SUPERIORITY_OR_OTHER_LEGACY|||||||0.021||95.0||||Multiplicity for multiple treatment comparisons was not adjusted.|ANCOVA|ANCOVA; classification variables: treatment, center, dosing sequence (stratification variable); covariate: baseline score||Null hypothesis: the concurrent administration of MFNS and OXY once daily has the same standardized AUC(0-4 hr) of the change from baseline in nasal congestion score as that of MFNS once daily.||||0.021
70979819|NCT00552110|141467807|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||Null hypothesis: the concurrent administration of MFNS and OXY once daily has the same standardized AUC (0-4hr) of the change from baseline in nasal congestion score as that of MFNS once daily||||<0.001
70979820|NCT00552110|141467807|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||Null hypothesis: the administration of OXY twice daily has the same standardized AUC(0-4 hr) of the change from baseline in nasal congestion score as that of placebo||||<0.001
70979821|NCT00332202|141467871|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.541|TWO_SIDED|95.0|0.689|1.216|||Log Rank|||||1.216|0.689|0.541
71096548|NCT00567580|141701925|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.268|TWO_SIDED|97.5|0.88|1.26||One-sided significance level = 0.025|Log Rank||Reference level = PBRT Alone|Late grade 2+ adverse events||1.26|0.88|0.268
71096549|NCT00567580|141701925|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.101|TWO_SIDED|97.5|0.93|1.32||One-sided significance level = 0.025|Log Rank||Reference level = PBRT + STAD|Late grade 2+ adverse events||1.32|0.93|0.101
71096550|NCT00567580|141701925|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.119|TWO_SIDED|97.5|0.83|1.8||One-sided significance level = 0.025|Log Rank||Reference level = PBRT Alone|Late grade 3+ adverse events||1.80|0.83|0.119
71096551|NCT00567580|141701925|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.17|TWO_SIDED|97.5|0.82|1.65||One-sided significance level = 0.025|Log Rank||Reference level = PBRT + STAD|Late grade 3+ adverse events||1.65|0.82|0.170
71096552|NCT03197935|141701937|SUPERIORITY||Absolute difference in pCR rate|16.5||||0.0044|TWO_SIDED|95.0|5.91|27.1||(one-sided)|Cochran-Mantel-Haenszel|||Stratified analysis. Strata are: tumor PD-L1 status (IC0 vs. IC1/2/3) and clinical stage at presentation (Stage II vs. III).||27.10|5.91|0.0044
71096553|NCT03197935|141701938|SUPERIORITY||Difference in pCR|19.5||||0.0206|TWO_SIDED|95.0|4.17|34.83||(one-sided)|Cochran-Mantel-Haenszel|||Stratified analysis. Strata are: AJCC stage at diagnosis (II vs. III).||34.83|4.17|0.0206
71096554|NCT03197935|141701939|OTHER|This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoint of EFS. The analyses of this secondary endpoint is descriptive in nature.|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.47|1.21|||Stratified log-rank test|||"Stratified analysis. Strata are:~Tumor PD-L1 status (IC0 vs IC1/2/3) and AJCC stage at diagnosis (II vs. III)."||1.21|0.47|
71096555|NCT03197935|141701940|OTHER|This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoint of EFS. The analyses of this secondary endpoint is descriptive in nature.|Hazard Ratio (HR)|0.55|||||TWO_SIDED|95.0|0.26|1.18|||Stratified log-rank test|||Stratified analysis. Strata are: AJCC stage at diagnosis (II vs. III).||1.18|0.26|
71096556|NCT03197935|141701941|OTHER|This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoint of DFS. The analyses of this secondary endpoint are descriptive in nature.|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.44|1.3|||Stratified log-rank test|||Stratified analysis. Strata are: Tumor PD-L1 status (IC0 vs IC1/2/3) and AJCC stage at diagnosis (II vs. III).||1.30|0.44|
71096557|NCT03197935|141701942|OTHER|This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoint of DFS. The analyses of this secondary endpoint are descriptive in nature.|Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.23|1.43|||Stratified log-rank test|||Stratified analysis. Strata are: AJCC stage at diagnosis (II vs. III).||1.43|0.23|
71096558|NCT03197935|141701943|OTHER|This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoints of OS. The analyses of this secondary endpoint are descriptive in nature.|Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.3|1.04|||Stratified log-rank test|||"Stratified analysis. Strata are:~Tumor PD-L1 status (IC0 vs IC1/2/3) and AJCC stage at diagnosis (II vs. III)."||1.04|0.30|
71096559|NCT03197935|141701944|OTHER|This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoints of EFS, DFS and OS. The analyses of this secondary endpoint are descriptive in nature.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.26|1.91|||Stratified log-rank test|||Stratified analysis. Strata are: AJCC stage at diagnosis (II vs. III).||1.91|0.26|
71096560|NCT00666978|141702080|SUPERIORITY|The x2 test was used to determine whether there was a difference between treatment groups (bupropion SR vs placebo) in verified 7-day point prevalence abstinence at week 26, imputing the missing participants as smokers.|Odds Ratio (OR)|1.39||||0.23|TWO_SIDED|95.0|0.82|2.35||All tests of statistical significance were two-sided, and all P values less than .05 were considered statistically significant.|t-test, 2 sided||Raw proportions were used to estimate the verified cessation rate in each group and corresponding odds ratio along with its 95% confidence interval .|Based on our previous studies, sample size was determined a priori assuming a two-sided x2 test with a type I error rate of .05, a power of 80%, and a cotinine-verified abstinence rate of 15% in the placebo group and 25% in the bupropion SR group at week 26, with the assumption that those lost to follow-up would be imputed as smokers.||2.35|0.82|.23
70979822|NCT00332202|141467877|SUPERIORITY_OR_OTHER|||||||0.606|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 2||||0.606
71096561|NCT00666978|141702081|OTHER||Odds Ratio (OR)|0.97||||0.0022|TWO_SIDED|95.0|0.95|0.99||This reflects Week 7.|Regression, Logistic||This reflects Week 7.|||0.99|0.95|0.0022
70979823|NCT00332202|141467877|SUPERIORITY_OR_OTHER|||||||0.971|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 4||||0.971
70979824|NCT00332202|141467877|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 6||||0.580
70979825|NCT00332202|141467877|SUPERIORITY_OR_OTHER|||||||0.265|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 12||||0.265
70979826|NCT00332202|141467877|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 18||||0.460
70979827|NCT00332202|141467877|SUPERIORITY_OR_OTHER|||||||0.441|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 24||||0.441
70979828|NCT00332202|141467877|SUPERIORITY_OR_OTHER|||||||0.357|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 36||||0.357
71096562|NCT00666978|141702082|OTHER||Odds Ratio (OR)|2.82|||<|0.05|TWO_SIDED|||||Analysis relied on examining quit rates using linear regression, where the hydroxybupropion was a significant predictor of smoking cessation. CYP2B6 genotype was not a direct significant predictor of cessation in either the placebo or bupropion arm.|Regression, Linear||Bupropion adherent individuals with higher hydroxybupropion levels were more likely to be abstinent at Weeks 3, 7 and 26 compared to individuals with lower hydroxybupropion levels.|||||<0.05
71096563|NCT00676052|141702103|SUPERIORITY||Mean Difference (Net)|0.067||||0.009|TWO_SIDED|95.0|0.017|0.117||Analysis performed using ANCOVA with covariates of Baseline, sex, age, smoking status, responsiveness stratum and treatment. Missing trough FEV1 data at Day 29 was imputed using LOCF.|ANCOVA|||||0.117|0.017|0.009
71096564|NCT00676052|141702103|SUPERIORITY||Mean Difference (Net)|0.097|||<|0.001|TWO_SIDED|95.0|0.047|0.147||Analysis performed using ANCOVA with covariates of Baseline, sex, age, smoking status, responsiveness stratum and treatment. Missing trough FEV1 data at Day 29 was imputed using LOCF.|ANCOVA|||||0.147|0.047|<0.001
71096565|NCT00676052|141702103|SUPERIORITY||Mean Difference (Net)|0.069||||0.007|TWO_SIDED|95.0|0.019|0.118||Analysis performed using ANCOVA with covariates of Baseline, sex, age, smoking status, responsiveness stratum and treatment. Missing trough FEV1 data at Day 29 was imputed using LOCF.|ANCOVA|||||0.118|0.019|0.007
71096566|NCT00676052|141702103|SUPERIORITY||Mean Difference (Net)|0.082||||0.001|TWO_SIDED|95.0|0.032|0.132||Analysis performed using ANCOVA with covariates of Baseline, sex, age, smoking status, responsiveness stratum and treatment. Missing trough FEV1 data at Day 29 was imputed using LOCF.|ANCOVA|||||0.132|0.032|0.001
71096567|NCT00676052|141702103|SUPERIORITY||Mean Difference (Net)|0.137|||<|0.001|TWO_SIDED|95.0|0.086|0.187||Analysis performed using ANCOVA with covariates of Baseline, sex, age, smoking status, responsiveness stratum and treatment. Missing trough FEV1 data at Day 29 was imputed using LOCF.|ANCOVA|||||0.187|0.086|<0.001
71096568|NCT00676052|141702104|SUPERIORITY||Mean Difference (Net)|0.106|||<|0.001|TWO_SIDED|95.0|0.065|0.146||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions|Repeated Measures Model|||FEV1, Day 1||0.146|0.065|<0.001
71096569|NCT00676052|141702104|SUPERIORITY||Mean Difference (Net)|0.107|||<|0.001|TWO_SIDED|95.0|0.067|0.147||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions|Repeated Measures Model|||FEV1, Day 1||0.147|0.067|<0.001
71096570|NCT00676052|141702104|SUPERIORITY||Mean Difference (Net)|0.123|||<|0.001|TWO_SIDED|95.0|0.083|0.163||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||FEV1, Day 1||0.163|0.083|<0.001
71096571|NCT00676052|141702104|SUPERIORITY||Mean Difference (Net)|0.152|||<|0.001|TWO_SIDED|95.0|0.112|0.193||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions|Repeated Measures Model|||FEV1, Day 1||0.193|0.112|<0.001
71096572|NCT00676052|141702104|SUPERIORITY||Mean Difference (Net)|0.176|||<|0.001|TWO_SIDED|95.0|0.135|0.216||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||FEV1, Day 1||0.216|0.135|<0.001
71096573|NCT00676052|141702104|SUPERIORITY||Mean Difference (Net)|0.106|||<|0.001|TWO_SIDED|95.0|0.056|0.157||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions|Repeated Measures Model|||FEV1, Day 28||0.157|0.056|<0.001
71096574|NCT00676052|141702104|SUPERIORITY||Mean Difference (Net)|0.142|||<|0.001|TWO_SIDED|95.0|0.092|0.192||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||FEV, Day 28||0.192|0.092|<0.001
71096575|NCT00676052|141702104|SUPERIORITY||Mean Difference (Net)|0.124|||<|0.001|TWO_SIDED|95.0|0.074|0.174||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions|Repeated Measures Model|||FEV1, Day 28||0.174|0.074|<0.001
71096576|NCT00676052|141702104|SUPERIORITY||Mean Difference (Net)|0.142|||<|0.001|TWO_SIDED|95.0|0.092|0.193||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||FEV1, Day 28||0.193|0.092|<0.001
70922732|NCT02638337|141336593|SUPERIORITY||LS Mean Difference|5.8|||<|0.0001|TWO_SIDED|95.0|4.2|7.3|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 4||7.3|4.2|<0.0001
70922733|NCT02638337|141336593|SUPERIORITY||LS Mean Difference|7.2|||<|0.0001|TWO_SIDED|95.0|5.5|9.0|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 8||9.0|5.5|<0.0001
70922734|NCT02638337|141336594|SUPERIORITY||LS Mean Difference|-0.58|||<|0.0001|TWO_SIDED|95.0|-0.69|-0.46|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 4||-0.46|-0.69|<0.0001
70922735|NCT02638337|141336594|SUPERIORITY||LS Mean Difference|-0.63|||<|0.0001|TWO_SIDED|95.0|-0.75|-0.51|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 8||-0.51|-0.75|<0.0001
71096577|NCT00676052|141702104|SUPERIORITY||Mean Difference (Net)|0.17|||<|0.001|TWO_SIDED|95.0|0.12|0.22||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||FEV1, Day 28||0.220|0.120|<0.001
71096578|NCT00676052|141702105|SUPERIORITY||Mean Difference (Net)|0.166|||<|0.001|TWO_SIDED|95.0|0.094|0.237||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 1||0.237|0.094|<0.001
71096579|NCT00676052|141702105|SUPERIORITY||Mean Difference (Net)|0.186|||<|0.001|TWO_SIDED|95.0|0.115|0.258||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 1||0.258|0.115|<0.001
71096580|NCT00676052|141702105|SUPERIORITY||Mean Difference (Net)|0.198|||<|0.001|TWO_SIDED|95.0|0.127|0.268||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 1||0.268|0.127|<0.001
71096581|NCT00676052|141702105|SUPERIORITY||Mean Difference (Net)|0.244|||<|0.001|TWO_SIDED|95.0|0.172|0.315||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 1||0.315|0.172|<0.001
71096582|NCT00676052|141702105|SUPERIORITY||Mean Difference (Net)|0.301|||<|0.001|TWO_SIDED|95.0|0.229|0.372||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 1||0.372|0.229|<0.001
71096583|NCT00676052|141702105|SUPERIORITY||Mean Difference (Net)|0.178|||<|0.001|TWO_SIDED|95.0|0.098|0.258||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 28||0.258|0.098|<0.001
71096584|NCT00676052|141702105|SUPERIORITY||Mean Difference (Net)|0.219|||<|0.001|TWO_SIDED|95.0|0.139|0.298||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 28||0.298|0.139|<0.001
71096585|NCT00676052|141702105|SUPERIORITY||Mean Difference (Net)|0.191|||<|0.001|TWO_SIDED|95.0|0.111|0.27||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 28||0.270|0.111|<0.001
71096586|NCT00676052|141702105|SUPERIORITY||Mean Difference (Net)|0.232|||<|0.001|TWO_SIDED|95.0|0.152|0.312||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 28||0.312|0.152|<0.001
71096587|NCT00676052|141702105|SUPERIORITY||Mean Difference (Net)|0.294|||<|0.001|TWO_SIDED|95.0|0.214|0.373||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 28||0.373|0.214|<0.001
71096588|NCT00676052|141702106|SUPERIORITY||Mean Difference (Net)|0.099||||0.021|TWO_SIDED|95.0|0.015|0.182||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||||0.182|0.015|0.021
71096589|NCT00676052|141702106|SUPERIORITY||Mean Difference (Net)|0.15|||<|0.001|TWO_SIDED|95.0|0.067|0.233||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||||0.233|0.067|<0.001
71096590|NCT00676052|141702106|SUPERIORITY||Mean Difference (Net)|0.094||||0.026|TWO_SIDED|95.0|0.011|0.177||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||||0.177|0.011|0.026
71096591|NCT00676052|141702106|SUPERIORITY||Mean Difference (Net)|0.163|||<|0.001|TWO_SIDED|95.0|0.08|0.247||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||||0.247|0.080|<0.001
71096592|NCT00676052|141702106|SUPERIORITY||Mean Difference (Net)|0.235|||<|0.001|TWO_SIDED|95.0|0.152|0.319||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||||0.319|0.152|<0.001
71096593|NCT01967277|141702123|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||H0: µL ≤ µs Versus Ha: µL \> µs||||<0.001
71096594|NCT01028560|141702136|OTHER||Slope|0.19|STANDARD_ERROR_OF_MEAN|0.22||0.38|TWO_SIDED|95.0|-0.24|0.63|||Mixed Models Analysis||The above is the slope for immunotherapy group . The (quadratic) slope is for 1 month increase in time.|Linear mixed effects model (LME) with random coefficients model was fitted with Restricted Maximum Likelihood estimation. The functional form of the model was quadratic and the model adjusted for gender, race, ethnicity and number of asthma hospitalizations since birth. Unequal data collection were smoothed over two month period with a median score values.||0.63|-0.24|0.38
71096595|NCT01028560|141702136|OTHER||Slope|0.55|STANDARD_ERROR_OF_MEAN|0.22||0.013|TWO_SIDED|95.0|0.11|0.99|||Mixed Models Analysis|The above (quadratic) slope is for control group|The above is the (quadratic) slope is for control group and is for 1 month increase in time.|Linear mixed effects model (LME) with random coefficients model was fitted with Restricted Maximum Likelihood estimation. The functional form of the model was quadratic and the model adjusted for gender, race, ethnicity and number of asthma hospitalizations since birth. Unequal data collection were smoothed over two month period with median score values.||0.99|0.11|0.013
71096596|NCT01028560|141702136|OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|4.97||0.978|TWO_SIDED|95.0|-11.76|12.03||Post estimation means were tested between the intervention arms after LME model at year 1 and the p- values were adjusted using Bonferroni correction.|contrast testing post mixed model||The difference is IT-Control group and the confidence interval is Bonferroni CI|Linear mixed effects model (LME) with random coefficients model was fitted with Restricted Maximum Likelihood estimation. The functional form of the model was quadratic and the model adjusted for gender, race, ethnicity and number of asthma hospitalizations since birth. Unequal data collection between immunotherapy and control groups were smoothed over two month period with a median score values.||12.03|-11.76|0.978
70979829|NCT00332202|141467878|SUPERIORITY_OR_OTHER|||||||0.267|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 6||||0.267
70979830|NCT00332202|141467878|SUPERIORITY_OR_OTHER|||||||0.807|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 24||||0.807
70979831|NCT00332202|141467878|SUPERIORITY_OR_OTHER|||||||0.864|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 33||||0.864
70979832|NCT00332202|141467879|SUPERIORITY||Hazard Ratio (HR)|0.768||||0.4|TWO_SIDED|95.0|0.415|1.42|||Regression, Cox|||||1.420|0.415|0.400
70979833|NCT00332202|141467879|SUPERIORITY||Hazard Ratio (HR)|1.309||||0.539|TWO_SIDED|95.0|0.557|3.08|||Regression, Cox|||||3.080|0.557|0.539
70979834|NCT00332202|141467880|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.775||||0.084|TWO_SIDED|95.0|0.947|3.329|||Regression, Cox|||||3.329|0.947|0.084
70979835|NCT00332202|141467880|SUPERIORITY||Hazard Ratio (HR)|1.286||||0.585|TWO_SIDED|95.0|0.527|3.137|||Regression, Cox|||||3.137|0.527|0.585
70979836|NCT03871491|141467882|SUPERIORITY||Risk Ratio (RR)|0.67|||<|0.001|TWO_SIDED|95.0|0.56|0.79||We calculated P values to test each of the primary hypotheses at an alpha level of 0.05 overall, with a nominal alpha level of 0.0001 at the interim analysis.|Regression, Logistic|Used multiple imputation for missing outcomes by means of logistic regression imputation.||The null hypothesis is there is no treatment effect on the incidence of maternal death or sepsis within 6 weeks (42 days) post-delivery||0.79|0.56|<0.001
71035311|NCT02558491|141579494|OTHER|||||||0.11||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.110
71035312|NCT02558491|141579495|OTHER|||||||0.018||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.018
71035313|NCT02558491|141579495|OTHER|||||||0.149||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.149
70979837|NCT03871491|141467883|SUPERIORITY||Risk Ratio (RR)|1.02||||0.56|TWO_SIDED|95.0|0.95|1.09||We calculated P values to test each of the primary hypotheses at an alpha level of 0.05 overall, with a nominal alpha level of 0.0001 at the interim analysis.|Regression, Logistic|Used multiple imputation for missing outcomes by means of logistic regression imputation.||The null hypothesis is there is no treatment effect on the incidence of Intrapartum/Neonatal Death or Sepsis Within 4 Weeks (28 Days) Post-delivery in Intervention vs. Placebo Group||1.09|0.95|0.56
70979838|NCT03871491|141467884|SUPERIORITY||Risk Ratio (RR)|0.65|||||TWO_SIDED|95.0|0.55|0.77||||||||0.77|0.55|
70979839|NCT03871491|141467885|SUPERIORITY||Risk Ratio (RR)|4.04|||||TWO_SIDED|95.0|0.45|36.14||||||||36.14|0.45|
70979840|NCT03871491|141467887|SUPERIORITY||Risk Ratio (RR)|0.66|||||TWO_SIDED|95.0|0.55|0.79||||||||0.79|0.55|
70979841|NCT03871491|141467888|SUPERIORITY||Risk Ratio (RR)|0.57|||||TWO_SIDED|95.0|0.43|0.75||||||||0.75|0.43|
70979842|NCT03871491|141467889|SUPERIORITY||Risk Ratio (RR)|0.8|||||TWO_SIDED|95.0|0.65|0.99||||||||0.99|0.65|
70979843|NCT03871491|141467890|SUPERIORITY||Risk Ratio (RR)|0.69|||||TWO_SIDED|95.0|0.56|0.85||||||||0.85|0.56|
70979844|NCT03871491|141467891|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.95|1.01||||||||1.01|0.95|
70979845|NCT03871491|141467893|SUPERIORITY||Risk Ratio (RR)|0.65|||||TWO_SIDED|95.0|0.52|0.82||||||||0.82|0.52|
70979846|NCT03871491|141467894|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.7|1.15||||||||1.15|0.70|
70979847|NCT03871491|141467895|SUPERIORITY||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.73|0.84||||||||0.84|0.73|
70979848|NCT03871491|141467896|SUPERIORITY||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.84|1.41||||||||1.41|0.84|
70979849|NCT03871491|141467897|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.96|1.1||||||||1.1|0.96|
70979850|NCT03871491|141467898|SUPERIORITY||Risk Ratio (RR)|1.04|||||TWO_SIDED|95.0|0.73|1.47||||||||1.47|0.73|
70979851|NCT03871491|141467899|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.88|1.07||||||||1.07|0.88|
70979852|NCT03871491|141467901|SUPERIORITY||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.96|1.21||||||||1.21|0.96|
70979853|NCT03871491|141467902|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.94|1.12||||||||1.12|0.94|
70979854|NCT03871491|141467903|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.93|1.0||||||||1.0|0.93|
70979855|NCT03871491|141467904|SUPERIORITY||Risk Ratio (RR)|2.68|||||TWO_SIDED|95.0|0.71|10.1||||||||10.1|0.71|
70979856|NCT00490542|141467924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4|||||TWO_SIDED|95.0|0.6|10.2||||||||10.2|0.6|
70979857|NCT03658954|141467925|SUPERIORITY|||||||0.75|||||||Mixed Models Analysis|||Testing for group effect.||||0.75
70979858|NCT03658954|141467926|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||Testing for group effect.||||0.05
70979859|NCT03658954|141467927|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||Testing for group effect.||||0.02
70979860|NCT02863198|141467942|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
71096597|NCT01028560|141702136|OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|5.89||0.77|TWO_SIDED|95.0|-15.83|12.38||Post estimation means were tested between the intervention arms after LME model at year 2 and the p- value was unadjusted p value|contrast testing post mixed model]||The difference is IT-Control group and the confidence interval is Bonferroni CI|Linear mixed effects model (LME) with random coefficients model was fitted with Restricted Maximum Likelihood estimation. The functional form of the model was quadratic and the model adjusted for gender, race, ethnicity and number of asthma hospitalizations since birth. Unequal data collection between immunotherapy and control groups were smoothed over two month period with a median score values.||12.38|-15.83|0.77
70979861|NCT02863198|141467943|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
70979862|NCT02863198|141467944|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|Chi-squared|||||||<0.05
70979863|NCT02863198|141467945|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
70979864|NCT02863198|141467946|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
70979865|NCT02863198|141467947|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|Chi-squared|||||||<0.05
70979866|NCT00666562|141467961|SUPERIORITY_OR_OTHER|||||||0.046|TWO_SIDED||||||t-test, 2 sided|||||||0.046
70979867|NCT01587989|141467981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.327||||0.188|TWO_SIDED|95.0|-0.165|0.82|||t-test, 2 sided|||||0.820|-0.165|0.188
70979868|NCT01587989|141467981|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||ANCOVA|||At Week 12.||||0.015
70979869|NCT01587989|141467981|SUPERIORITY_OR_OTHER|||||||0.304|TWO_SIDED||||||ANCOVA|||Adjusted change in DAS28 score from Weeks 12-24.||||0.304
70979870|NCT01587989|141467982|SUPERIORITY_OR_OTHER|||||||0.732|TWO_SIDED||||||Fisher Exact|||||||0.732
70979871|NCT01587989|141467983|SUPERIORITY_OR_OTHER|||||||0.207|TWO_SIDED||||||Fisher Exact|||||||0.207
70979872|NCT01587989|141467984|SUPERIORITY_OR_OTHER|||||||0.453|TWO_SIDED||||||Fisher Exact|||||||0.453
70979873|NCT01587989|141467985|SUPERIORITY_OR_OTHER|||||||0.084|TWO_SIDED||||||Fisher Exact|||||||0.084
70979874|NCT01587989|141467986|SUPERIORITY_OR_OTHER|||||||0.842|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.842
70979875|NCT01587989|141467987|SUPERIORITY_OR_OTHER|||||||0.417|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Physical standardized value||||0.417
70979876|NCT01587989|141467987|SUPERIORITY_OR_OTHER|||||||0.112|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Mental standardized value||||0.112
70979877|NCT01587989|141467988|SUPERIORITY_OR_OTHER|||||||0.655|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Fatigue||||0.655
70979878|NCT01587989|141467988|SUPERIORITY_OR_OTHER|||||||0.839|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Pain||||0.839
70979879|NCT01587989|141467989|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Effectiveness||||0.580
70979880|NCT01587989|141467989|SUPERIORITY_OR_OTHER|||||||0.975|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Side-effects||||0.975
70979881|NCT01587989|141467989|SUPERIORITY_OR_OTHER|||||||0.421|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Convenience||||0.421
70979882|NCT01587989|141467989|SUPERIORITY_OR_OTHER|||||||0.277|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Global satisfaction||||0.277
70979883|NCT03128957|141468000|EQUIVALENCE|Given the small sample permutation are feasible.||||||0.036|||||||permutation test|Given the non-parametric nature of spearman's correlation coefficient and a small sample we used a permutation test to calculate p-values.||Non-parametric covariance adjusted Spearman's correlation ρ\_s. To test the Null that Ho: ρ\_s.=0 vs alternative that Ha: ρ\_s.≠0, we used a method that calculates the probability that it would be greater than or equal to the observed ρ ̂, given the null hypothesis, by using a permutation test. An advantage of this approach is that it automatically takes into account the number of tied data values in the sample and the way they are treated in computing the rank correlation.||||0.036
70979884|NCT03128957|141468001|SUPERIORITY|||||||0.015|||||||Kruskal-Wallis|||Set point 1 (FiO2 0.3 and PaCO2 30 mmHg) compared to set point 2 (FiO2 1.0 and PaCO2 40 mmHg)||||0.015
70979885|NCT03128957|141468002|SUPERIORITY|||||||0.047|||||||Kruskal-Wallis|||Set point 1 (FiO2 0.3 and PaCO2 30 mmHg) compared to set point 2 (FiO2 1.0 and PaCO2 40 mmHg)||||0.047
70979886|NCT05198713|141468004|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70979887|NCT03274687|141468020|NON_INFERIORITY|The non-inferiority margin for the difference in mean change score (∆2 - ∆1) is -5.||||||0.98|||||||t-test, 1 sided|||Null hypothesis (H0): mean change score of HYPORT (∆2) is worse than that of COPORT (∆1), specifically ∆2 - ∆1 \< -5. Alternative hypothesis (HA): ∆2 is not worse than ∆1, specifically ∆2 - ∆1 ≥ -5. The study sample size is based on 90% power for this endpoint and 91% power for the bowel endpoint (resulting in 81.9% statistical power to reject the null hypothesis for both endpoints) and a one-sided alpha=0.025 with an overall type I error of 0.05 with a Bonferroni adjustment.||||0.98
70979888|NCT03274687|141468021|NON_INFERIORITY|The non-inferiority margin for the difference in mean change score (∆2 - ∆1) is -6.||||||0.96|||||||t-test, 1 sided|||Null hypothesis (H0): mean change score of HYPORT (∆2) is worse than that of COPORT (∆1), specifically ∆2 - ∆1 \< -5. Alternative hypothesis (HA): ∆2 is not worse than ∆1, specifically ∆2 - ∆1 ≥ -5. The study sample size is based on 91% power for this endpoint and 90% power for the urinary endpoint (resulting in 81.9% statistical power to reject the null hypothesis for both endpoints) and a one-sided alpha=0.025 with an overall type I error of 0.05 with a Bonferroni adjustment.||||0.96
70979889|NCT03274687|141468022|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||End of RT||||0.70
70979890|NCT03274687|141468022|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||6 months||||0.67
70979891|NCT03274687|141468022|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||1 year||||0.66
70979892|NCT03274687|141468023|SUPERIORITY|||||||0.0011|||||||t-test, 2 sided|||End of RT||||0.0011
70979893|NCT03274687|141468023|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||6 months||||0.93
70979894|NCT03274687|141468023|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||1 year||||0.30
70979895|NCT03274687|141468024|SUPERIORITY|||||||0.29|||||||Gray's test|Two-sided significance level 0.05||Protocol definition of biochemical failure||||0.29
70979896|NCT03274687|141468024|SUPERIORITY|||||||0.22|||||||Gray's test|Two-sided significance level 0.05||Phoenix definition of biochemical failure||||0.22
70979897|NCT03274687|141468025|SUPERIORITY|||||||0.96||||||Two-sided significance level 0.05|Gray's test|||||||0.96
71035314|NCT02558491|141579495|OTHER|||||||0.109||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.109
70979898|NCT03274687|141468026|SUPERIORITY|||||||0.35||||||Two-sided significance level 0.05|Gray's test|||||||0.35
70979899|NCT03274687|141468027|SUPERIORITY|||||||0.41||||||Two-sided significance level 0.05|Gray's test|||||||0.41
70979900|NCT03274687|141468028|SUPERIORITY|||||||0.6||||||Two-sided significance level 0.05|Gray's test|||||||0.60
70979901|NCT03274687|141468030|SUPERIORITY||Hazard Ratio (HR)|1.58||||0.61|TWO_SIDED|95.0|0.26|9.47||Two-side significance level 0.05|Log Rank||Reference = COPORT|||9.47|0.26|0.61
70979902|NCT03274687|141468031|SUPERIORITY|||||||0.53|||||||Chi-squared|||Patients with any grade 3 or higher adverse event of any attribution||||0.53
70979903|NCT03274687|141468031|SUPERIORITY|||||||0.6929|||||||Chi-squared|||Patients with any grade 3 or higher gastrointestinal adverse event of any attribution||||0.6929
70979904|NCT03274687|141468031|SUPERIORITY|||||||0.2605|||||||Chi-squared|||Patients with any grade 3 or higher genitourinary adverse event of any attribution||||0.2605
70979905|NCT00318292|141468058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.003||95.0|-3.2|-0.7|||t-test, 2 sided|||||-0.7|-3.2|.003
70979906|NCT00824564|141468059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-55.5|STANDARD_ERROR_OF_MEAN|58.63||0.348|TWO_SIDED|95.0|-172.7|61.7|||t-test, 2 sided|||The mean difference with associated standard error (SE), and corresponding 95% confidence interval (CI) for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||61.7|-172.7|0.348
71035315|NCT02558491|141579496|OTHER|||||||0.78||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.78
71035316|NCT02558491|141579496|OTHER|||||||0.399||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.399
71035317|NCT02558491|141579496|OTHER|||||||0.824||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.824
71035318|NCT02558491|141579497|OTHER|||||||0.863||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.863
71096598|NCT01028560|141702136|OTHER||Mean Difference (Final Values)|-1.85|STANDARD_ERROR_OF_MEAN|7.39||0.8|TWO_SIDED|95.0|-19.54|15.84||Post estimation means were tested between the intervention arms after LME model at year 3 and the p- values were adjusted using Bonferroni correction.|contrast testing post mixed model||The difference is IT-Control group and the confidence interval is Bonferroni CI|Linear mixed effects model (LME) with random coefficients model was fitted with Restricted Maximum Likelihood estimation. The functional form of the model was quadratic and the model adjusted for gender, race, ethnicity and number of asthma hospitalizations since birth. Unequal data collection between immunotherapy and control groups were smoothed over two month period with a median score values.||15.84|-19.54|0.80
70922736|NCT02638337|141336595|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0005|TWO_SIDED|95.0|1.27|2.36|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 4||2.36|1.27|0.0005
70922737|NCT02638337|141336595|SUPERIORITY||Odds Ratio (OR)|2.01|||<|0.0001|TWO_SIDED|95.0|1.47|2.74|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 8||2.74|1.47|<0.0001
71035319|NCT02558491|141579497|OTHER|||||||0.965||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.965
71035320|NCT02558491|141579497|OTHER|||||||0.742||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.742
71035321|NCT02558491|141579498|OTHER|||||||0.158||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.158
71035322|NCT02558491|141579498|OTHER|||||||0.085||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.085
71035323|NCT02558491|141579498|OTHER|||||||0.055||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.055
71035324|NCT02558491|141579499|OTHER|||||||0.744||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.744
71035325|NCT02558491|141579499|OTHER|||||||0.248||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.248
71035326|NCT02558491|141579499|OTHER|||||||0.225||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.225
70979907|NCT00824564|141468060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.0|STANDARD_ERROR_OF_MEAN|32.78||0.466|TWO_SIDED|95.0|-41.3|89.3|||t-test, 2 sided|||The mean difference with associated SE and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||89.3|-41.3|0.466
70979908|NCT00824564|141468061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.3|STANDARD_ERROR_OF_MEAN|5.57||0.109|TWO_SIDED|95.0|-20.7|2.2|||t-test, 2 sided|||For 1 hour post-surgery, the mean difference with associated SE and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||2.2|-20.7|0.109
70979909|NCT00824564|141468061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.8|STANDARD_ERROR_OF_MEAN|3.24||0.045|TWO_SIDED|95.0|-13.4|-0.1|||t-test, 2 sided|||For 4 hour post-surgery, the mean difference with associated SE, and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||-0.1|-13.4|0.045
70979910|NCT00824564|141468061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.8|STANDARD_ERROR_OF_MEAN|4.2||0.119|TWO_SIDED|95.0|-15.4|1.8|||t-test, 2 sided|||For 8 hour post-surgery, the mean difference with associated SE, and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||1.8|-15.4|0.119
70979911|NCT00824564|141468061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.7|STANDARD_ERROR_OF_MEAN|15.16||0.139|TWO_SIDED|95.0|-52.9|7.5|||t-test, 2 sided|||For 24 hour post-surgery, the mean difference with associated SE, and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||7.5|-52.9|0.139
70979912|NCT00824564|141468062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.2|STANDARD_ERROR_OF_MEAN|132.1||0.849|TWO_SIDED|95.0|-238.2|288.6|||t-test, 2 sided|||The mean difference with associated SE, and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||288.6|-238.2|0.849
70979913|NCT00824564|141468063|SUPERIORITY_OR_OTHER|||||||0.714|TWO_SIDED||||||Chi-squared|||Chi-square test was used at 5% level of significance.||||0.714
70979914|NCT00824564|141468064|SUPERIORITY_OR_OTHER||Least square means difference|0.37|STANDARD_ERROR_OF_MEAN|0.295||0.208|TWO_SIDED|95.0|-0.21|0.96|||Mixed Models Analysis|||For change at end of surgery, a Mixed Model Repeated Measures (MMRM) approach was used to relate the dependent (outcome) variable and independent (treatment, time point, and treatment-by-time point interaction as factors and baseline value as co-variate) variables taking into account the within-participant correlation arising from the repeated measurements.||0.96|-0.21|0.208
70979915|NCT00824564|141468064|SUPERIORITY_OR_OTHER||Least square means difference|0.1|STANDARD_ERROR_OF_MEAN|0.255||0.682|TWO_SIDED|95.0|-0.4|0.61|||Mixed Models Analysis|||For change at 1 hour post-surgery, a MMRM approach was used to relate the dependent (outcome) variable and independent (treatment, time point, and treatment-by-time point interaction as factors and baseline value as co-variate) variables taking into account the within-participant correlation arising from the repeated measurements.||0.61|-0.40|0.682
70979916|NCT00824564|141468064|SUPERIORITY_OR_OTHER||Least square means difference|0.14|STANDARD_ERROR_OF_MEAN|0.244||0.569|TWO_SIDED|95.0|-0.35|0.63|||Mixed Models Analysis|||For change at day 1 post-surgery, a MMRM approach was used to relate the dependent (outcome) variable and independent (treatment, time point, and treatment-by-time point interaction as factors and baseline value as co-variate) variables taking into account the within-participant correlation arising from the repeated measurements.||0.63|-0.35|0.569
70979917|NCT00824564|141468064|SUPERIORITY_OR_OTHER||Least square means difference|0.2|STANDARD_ERROR_OF_MEAN|0.249||0.413|TWO_SIDED|95.0|-0.29|0.7|||Mixed Models Analysis|||For change at day 2 post-surgery, a MMRM approach was used to relate the dependent (outcome) variable and independent (treatment, time point, and treatment-by-time point interaction as factors and baseline value as co-variate) variables taking into account the within-participant correlation arising from the repeated measurements.||0.70|-0.29|0.413
70979918|NCT00824564|141468064|SUPERIORITY_OR_OTHER||Least square means difference|0.11|STANDARD_ERROR_OF_MEAN|0.276||0.686|TWO_SIDED|95.0|-0.44|0.66|||Mixed Models Analysis|||For change at day 4/ET post-surgery, a MMRM approach was used to relate the dependent (outcome) variable and independent (treatment, time point, and treatment-by-time point interaction as factors and baseline value as co-variate) variables taking into account the within-participant correlation arising from the repeated measurements.||0.66|-0.44|0.686
71035327|NCT02558491|141579500|OTHER|||||||0.86||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.86
71035328|NCT02558491|141579500|OTHER|||||||0.522||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.522
71096599|NCT01028560|141702137|SUPERIORITY|||||||0.677||||||Chi-square test (proportion of new sensitizations versus unchanged or lost sensitizations in each group, intention-to treat analysis).|Chi-squared|||||||0.677
71096600|NCT01028560|141702138|SUPERIORITY||Slope|0.56||||0.546|TWO_SIDED|95.0|-2.18|3.29||Test of parallelism (group x time) hypothesis P-value.|covariance pattern (rep. measure) model|Within group difference p-values ( baseline vs 3-years) in control and intervention arm were 0.56 and 0.20 respectively.|The estimated slope reported is for year 3 from the covariance pattern model with autoregressive covariance structure.|Covariance Pattern Model with autoregressive covariance structure with REML (Restricted Estimation of Maximum Likelihood) with time and role as categorical variable was modeled.||3.29|-2.18|0.5460
71096601|NCT01028560|141702139|SUPERIORITY||Rate ratio|1.27||||0.289|TWO_SIDED|95.0|0.82|1.96||Poisson regression model for treatment arm adjusting for gender, race and history of hospitalization was used to analyze the corticosteroid burst and the time period contributed by each child in years were fitted as offset.|Poisson regression|Poisson regression model with robust variance with contributed person years used as offset was modeled.||Null hypothesis = Incidence rate of CSB in each group are same. Poisson regression adjusting for gender, race and history of hospitalization was used to analyze the corticosteroid burst.||1.96|0.82|0.289
71096602|NCT01243424|141702143|NON_INFERIORITY|This was the first step in a pre-defined hierarchical testing approach. The upper bound of the confidence interval (CI) of the Hazard ratio (HR) of linagliptin vs. glimepiride was compared with this noninferiority margin for the testing of non-inferiority. All non-inferiority tests were based on a margin of 1.3.|Hazard Ratio (HR)|0.98|||<|0.0001|TWO_SIDED|95.47|0.84|1.14||P-values derived from Wald´s Chi-square test for non-inferiority were calculated.|Regression, Cox|Cox proportional-hazard model with factor treatment was applied to compare linagliptin with glimepiride||||1.14|0.84|<0.0001
71096603|NCT01243424|141702143|SUPERIORITY|This was the second step in a pre-defined hierarchical testing approach.|Hazard Ratio (HR)|0.98||||0.3813|TWO_SIDED|95.47|0.84|1.14||P-values derived from Wald´s Chi-square test.|Regression, Cox|Cox proportional-hazard model with factor treatment was applied to compare linagliptin with glimepiride.||||1.14|0.84|0.3813
71096604|NCT01243424|141702144|SUPERIORITY|This was the third step in a pre-defined hierarchical testing approach.|Hazard Ratio (HR)|0.99||||0.4334|TWO_SIDED|95.47|0.86|1.14||P-values derived from Wald´s Chi-square test for non-inferiority.|Regression, Cox|Cox proportional-hazard model with factor treatment was applied to compare linagliptin with glimepiride.||||1.14|0.86|0.4334
71096605|NCT01243424|141702145|OTHER||Odds Ratio (OR)|1.68|||<|0.0001|TWO_SIDED|95.47|1.43|1.96||p-value derived from logistic regression.|Regression, Logistic||Odds ratio and confidence interval are based on logistic regression with factor for treatment.|||1.96|1.43|<0.0001
71096606|NCT01243424|141702146|OTHER||Odds Ratio (OR)|1.29||||0.0004|TWO_SIDED|95.47|1.11|1.48||p-value derived from logistic regression.|Regression, Logistic||Odds ratio and confidence interval are based on logistic regression with factor for treatment.|This was the fifth step in a pre-defined hierarchical testing approach.||1.48|1.11|0.0004
71096607|NCT01243424|141702150|OTHER||Hazard Ratio (HR)|0.96||||0.5249|TWO_SIDED|95.0|0.85|1.09||p-value derived from Wald´s chi-square test.|Regression, Cox||Hazard ratio and confidence interval derived from Cox regression with factor treatment.|This was the fifth step in a pre-defined hierarchical testing approach.||1.09|0.85|0.5249
71096608|NCT01243424|141702151|OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.03||0.0023|TWO_SIDED|95.0|-0.15|-0.03|||ANCOVA|The Analysis of Covariance (ANCOVA) model includes the fixed categorical effect of treatment and the continuous covariate of baseline HbA1c.|Mean difference = Linagliptin mean - Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.||-0.03|-0.15|0.0023
71096609|NCT01243424|141702152|OTHER||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|-9.7|-4.8|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline FPG.|Mean difference = Linagliptin mean - Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.||-4.8|-9.7|<0.0001
71096610|NCT01243424|141702153|OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.9||0.64|TWO_SIDED|95.47|-1.3|2.1|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline LDL cholesterol.|Mean difference = Linagliptin mean - Glimepiride mean|LDL cholesterol, this was the fifth step in a pre-defined hierarchical testing approach.||2.1|-1.3|0.6400
71096611|NCT01243424|141702153|OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.2||0.0497|TWO_SIDED|95.0|0.0|1.0|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline HDL cholesterol.|Mean difference = Linagliptin mean - Glimepiride mean|HDL cholesterol, this was the fifth step in a pre-defined hierarchical testing approach.||1.0|0.0|0.0497
71096612|NCT01243424|141702153|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.0||0.6823|TWO_SIDED|95.0|-2.4|1.6|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline total cholesterol.|Mean difference = Linagliptin mean - Glimepiride mean|Total cholesterol, this was the fifth step in a pre-defined hierarchical testing approach.||1.6|-2.4|0.6823
71096613|NCT01243424|141702154|OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|3.1||0.2678|TWO_SIDED|95.0|-9.6|2.7|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline FPG.|Mean difference = Linagliptin mean - Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.||2.7|-9.6|0.2678
71096614|NCT01243424|141702155|OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.5165|TWO_SIDED|95.0|-0.03|0.01|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline creatinine.|Mean difference = Linagliptin mean - Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.||0.01|-0.03|0.5165
71096615|NCT01243424|141702156|OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.4||0.5165|TWO_SIDED|95.0|0.2|1.8|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline eGFR.|Mean difference = Linagliptin mean - Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.||1.8|0.2|0.5165
71096616|NCT01243424|141702157|OTHER||geometric mean (gMean) ratio (%)|0.97||||0.2921|TWO_SIDED|95.0|0.91|1.03|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline UACR.|gMean ration= Linagliptin mean/ Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.||1.03|0.91|0.2921
70979919|NCT00824564|141468065|SUPERIORITY_OR_OTHER|||||||0.241|TWO_SIDED||||||Fisher Exact|||Fisher's exact test at 5% level of significance was used as the event rate was low and the expected count for any cell in the (unstratified) 2\*2 contingency table was less than 5.||||0.241
71035329|NCT02558491|141579500|OTHER|||||||0.522||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.522
71096617|NCT01243424|141702159|EQUIVALENCE|This was the fifth step in a pre-defined hierarchical testing approach.|Mean Difference (Net)|4.13||||0.8402|TWO_SIDED|95.0|-36.46|44.71|||ANCOVA|The ANCOVA model includes the fixed categorical effects of treatment and the continuous covariate of baseline ISR.|Mean difference= Linagliptin mean- Glimepiride mean|||44.71|-36.46|0.8402
70979920|NCT04178590|141468068|SUPERIORITY|||||||0.429||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.429
70979921|NCT04178590|141468069|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
70979922|NCT04178590|141468070|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
70979923|NCT04178590|141468071|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
70979924|NCT04178590|141468072|SUPERIORITY|||||||0.575||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.575
71035330|NCT02558491|141579501|OTHER|||||||0.301||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.301
71035331|NCT02558491|141579502|OTHER|||||||0.189||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.189
71096618|NCT01243424|141702160|OTHER||Odds Ratio (OR)|1.01||||0.9112|TWO_SIDED|95.0|0.86|1.18|||Regression, Logistic|Logistic regression model with terms for treatment as a fixed effect with Wald confidence Interval was used.|Linagliptin vs. Glimepiride odds is presented.|This was the fifth step in a pre-defined hierarchical testing approach.||1.18|0.86|0.9112
71035332|NCT02558491|141579503|OTHER|||||||0.271||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.271
71096619|NCT00397930|141702166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.3||0.009|TWO_SIDED|||||Between-group differences are expressed as differences in mean Post-Pre change for the global sleep quality PSQI score.|ANCOVA|ANCOVA with post-intervention PSQI score as the outcome, with Group as the factor, and pre-intervention PSQI score as the covariate.|The negative estimated value indicates that the mean Post-Pre change for the YOCAS group was less than that of the Control group.|"H0: There is no statistically significant difference in global sleep quality between post-treatment cancer survivors under the standardized yoga intervention and control protocol at the 0.05 two-sided significance level.~Ha: There is a statistically significant difference in global sleep quality between post-treatment cancer survivors under the standardized yoga intervention and control protocol at the 0.05 two-sided significance level."||||0.009
70979925|NCT04178590|141468073|SUPERIORITY|||||||0.575||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.575
70979926|NCT04178590|141468074|SUPERIORITY|||||||0.249||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.249
70979927|NCT04178590|141468075|SUPERIORITY|||||||0.871||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.871
70979928|NCT04178590|141468076|SUPERIORITY|||||||0.773||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.773
70979929|NCT04178590|141468077|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
70979930|NCT04178590|141468078|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|p\<0.05||||||0.000
70979931|NCT04178590|141468079|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
70979932|NCT04178590|141468080|SUPERIORITY|||||||0.063||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.063
70979933|NCT04178590|141468081|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
70979934|NCT04178590|141468082|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
70979935|NCT04178590|141468083|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
70979936|NCT04178590|141468084|SUPERIORITY|||||||0.085||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.085
70979937|NCT04178590|141468085|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
70979938|NCT04178590|141468086|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
70979939|NCT04178590|141468087|SUPERIORITY|||||||0.895||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.895
70979940|NCT04178590|141468088|SUPERIORITY|||||||0.999||||||p\<0.05|McNemar|||||||0.999
70979941|NCT04178590|141468089|SUPERIORITY|||||||0||||||p\<0.05|McNemar|||||||0.000
70979942|NCT04178590|141468090|SUPERIORITY|||||||0.008||||||p\<0.05|McNemar|||||||0.008
70979943|NCT04178590|141468091|SUPERIORITY|||||||0.5||||||p\<0.05|McNemar|||||||0.500
70979944|NCT04178590|141468092|SUPERIORITY|||||||0.999||||||p\<0.05|McNemar|||||||0.999
71035333|NCT00834431|141579504|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|92.0||||||90.0|85.9|98.6|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||98.6|85.9|
70979945|NCT04178590|141468093|SUPERIORITY|||||||0||||||p\<0.05|McNemar|||||||0.000
70979946|NCT04178590|141468094|SUPERIORITY|||||||0.4||||||p\<0.05|McNemar|||||||0.40
70979947|NCT04178590|141468095|SUPERIORITY|||||||0.999|||||||McNemar|||||||0.999
70979948|NCT04178590|141468096|SUPERIORITY|||||||0.999||||||p\<0.05|McNemar|||||||0.999
70979949|NCT04178590|141468097|SUPERIORITY|||||||0.001||||||p\<0.05|McNemar|||||||0.001
70979950|NCT04178590|141468098|SUPERIORITY|||||||0.453||||||p\<0.05|McNemar|||||||0.453
70979951|NCT04178590|141468099|SUPERIORITY|||||||0.625||||||p\<0.05|McNemar|||||||0.625
70979952|NCT04178590|141468100|SUPERIORITY|||||||0.999|||||||McNemar|||||||0.999
70979953|NCT04178590|141468101|SUPERIORITY|||||||0||||||p\<0.05|McNemar|||||||0.000
70979954|NCT04178590|141468102|SUPERIORITY|||||||0.001||||||p\<0.05|McNemar|||||||0.001
70979955|NCT04178590|141468103|SUPERIORITY|||||||0.065||||||p\<0.05|McNemar|||||||0.065
70979956|NCT04178590|141468104|SUPERIORITY|||||||0.821||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.821
71035334|NCT00834431|141579505|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.6||||||90.0|96.2|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101|96.2|
71096620|NCT01960842|141702167|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.64|||<|0.001|TWO_SIDED|95.0|-5.78|-3.5|||One-sample t-test, 2-sided|||||-3.50|-5.78|<0.001
71096621|NCT01960842|141702168|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.58|||<|0.001|TWO_SIDED|95.0|4.21|6.95|||One-sample t-test, 2-sided|||||6.95|4.21|<0.001
70979957|NCT04178590|141468105|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
70979958|NCT04178590|141468106|SUPERIORITY|||||||0.001||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.001
70979959|NCT04178590|141468107|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
70979960|NCT04178590|141468108|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
70979961|NCT04178590|141468109|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
70979962|NCT04178590|141468110|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
70979963|NCT04178590|141468111|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||||||0.000
70979964|NCT04178590|141468112|SUPERIORITY|||||||0.671||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.671
70979965|NCT04178590|141468113|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
70979966|NCT04178590|141468114|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
70979967|NCT04178590|141468115|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||||||0.000
70979968|NCT04178590|141468116|SUPERIORITY|||||||0.753||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.753
70979969|NCT04178590|141468117|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
70979970|NCT04178590|141468118|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
70979971|NCT04178590|141468119|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
70979972|NCT00310310|141468157|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 1 sided|||||||0.001
70979973|NCT00310310|141468158|SUPERIORITY_OR_OTHER|||||||0.023|||||||t-test, 1 sided|||||||0.023
70979974|NCT00310310|141468159|SUPERIORITY_OR_OTHER|||||||0.8|||||||t-test, 1 sided|||||||0.8
70979975|NCT00310310|141468161|SUPERIORITY_OR_OTHER|||||||0.96|||||||t-test, 1 sided|||||||0.96
70979976|NCT00310310|141468162|SUPERIORITY_OR_OTHER|||||||0.59|||||||t-test, 1 sided|||||||0.59
70979977|NCT00310310|141468163|SUPERIORITY_OR_OTHER|||||||0|||||||t-test, 1 sided|||||||0.00
70979978|NCT00310310|141468164|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 1 sided|||||||0.02
70979979|NCT00310310|141468165|SUPERIORITY_OR_OTHER|||||||0.08|||||||t-test, 1 sided|||||||0.08
70979980|NCT00310310|141468166|SUPERIORITY_OR_OTHER|||||||0.38|||||||t-test, 1 sided|||||||0.38
70979981|NCT00363415|141468167|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.56|||<|0.01||95.0|1.27|1.92|||Log Rank|||||1.92|1.27|<0.01
70979982|NCT00363415|141468168|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Sex: Male|Log Rank|||||||<0.001
70979983|NCT00363415|141468168|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value for Sex: Female|Log Rank|||||||0.023
70979984|NCT00363415|141468168|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Race: Caucasian.|Log Rank|||||||<0.001
70979985|NCT00363415|141468168|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-value for Race: Non-Caucasian.|Log Rank|||||||0.030
70979986|NCT00363415|141468168|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for ECOG (Eastern Cooperative Oncology Group) Performance Status: 0 or 1.|Log Rank|||||||<0.001
70979987|NCT00363415|141468168|SUPERIORITY_OR_OTHER|||||||0.519||95.0||||P-value for ECOG (Eastern Cooperative Oncology Group) Performance Status: 2.|Log Rank|||||||0.519
70979988|NCT00363415|141468168|SUPERIORITY_OR_OTHER|||||||0.084||95.0||||P-value for Region: United States.|Log Rank|||||||0.084
70979989|NCT00363415|141468168|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Region: European Union.|Log Rank|||||||0.001
70979990|NCT00363415|141468168|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Region: Intercontinental Region.|Log Rank|||||||0.003
70979991|NCT00363415|141468168|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for LDH (lactate dehydrogenase): \>Upper Limit of Normal.|Log Rank|||||||0.005
70979992|NCT00363415|141468168|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Age: \<=65 years.|Log Rank|||||||<0.001
70979993|NCT00363415|141468168|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Age: \>65 years.|Log Rank|||||||0.013
70979994|NCT00363415|141468168|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||P-value for Number Metastatic Sites: \<=2.|Log Rank|||||||0.092
70979995|NCT00363415|141468168|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Number Metastatic Sites: \>=3.|Log Rank|||||||<0.001
70979996|NCT00363415|141468168|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for History of Brain Metastases: No.|Log Rank|||||||<0.001
70979997|NCT01025635|141468285|SUPERIORITY_OR_OTHER_LEGACY|||||||0.017|||||||Cochran-Mantel-Haenszel|study center adjusted||||||0.017
70979998|NCT01025635|141468286|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|with factors treatment group, study center, and baseline lesion count as covariate||||||<0.001
70979999|NCT05292755|141468290|OTHER|One-way ANOVA was used to compare mean Faith's phylogenetic diversity before and after treatment for each intervention group at a two-tailed 95% confidence interval.||||||0.232|||||||ANOVA|||||||0.232
70980000|NCT05292755|141468291|OTHER|||||||0.224|||||||ANOVA|||ANOVA was used to compare mean Shannon's diversity indices before and after treatment for each intervention group at a two-tailed 95% confidence interval.||||0.224
70980001|NCT05292755|141468292|OTHER|||||||0.227|||||||Repeated measures Mann-U-Whitney|||Repeated measures Mann-U-Whitney tests were used to compare changes in weighted and unweighted UniFrac distances between intervention groups before and after intervention at a two-tailed 95% confidence interval.||||0.227
70980002|NCT00432809|141468298|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|95.0|||||Chi-squared|||||||0.002
70980003|NCT00432809|141468298|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Chi-squared|||||||0.008
70980004|NCT00432809|141468298|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||Not adjusted for multiple comparisons|Chi-squared|||||||0.59
70980005|NCT00432809|141468302|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
70980006|NCT00432809|141468302|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
70980007|NCT00432809|141468302|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANOVA|||||||0.85
71035335|NCT00834431|141579506|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.7||||||90.0|96.3|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101|96.3|
71035336|NCT00835263|141579509|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|103.23||||||90.0|100.78|105.73|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.73|100.78|
71096622|NCT01960842|141702169|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.0|||<|0.001|TWO_SIDED|95.0|-16.3|-7.7|||One-sample t-test, 2-sided|||||-7.7|-16.3|<0.001
71096623|NCT01960842|141702170|SUPERIORITY_OR_OTHER||Mean change from score = 4|-2.1|STANDARD_DEVIATION|0.77|<|0.001|TWO_SIDED||||||Wilcoxon signed-rank test|||The p-value is based on a one-sample Wilcoxon signed-rank test with the hypothesis of no change (score = 4).||||<0.001
70980008|NCT00432809|141468303|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.004
70980009|NCT00432809|141468303|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.003
70980010|NCT00432809|141468303|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.86
70980011|NCT00432809|141468304|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
70980012|NCT00432809|141468304|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANOVA|||||||0.003
70980013|NCT00432809|141468304|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||ANOVA|||||||0.23
70980014|NCT00432809|141468305|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Medical Therapy vs. Gastric Bypass||||<0.001
71035337|NCT00835263|141579510|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|103.31||||||90.0|100.75|105.93|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.93|100.75|
70980015|NCT00432809|141468305|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
70980016|NCT00432809|141468305|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Chi-squared|||||||0.10
70980017|NCT00432809|141468306|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
70980018|NCT00432809|141468306|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
70980019|NCT00432809|141468306|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|||||||0.02
70980020|NCT00432809|141468307|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
70980021|NCT00432809|141468307|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
70980022|NCT00432809|141468307|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|||||||0.02
70980023|NCT00432809|141468308|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
70980024|NCT00432809|141468308|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
70980025|NCT00432809|141468308|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||ANOVA|||||||0.61
70980026|NCT00432809|141468309|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
70980027|NCT00432809|141468309|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
70980028|NCT00432809|141468309|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANOVA|||||||0.03
70980029|NCT00432809|141468310|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||ANOVA|||||||0.87
70980030|NCT00432809|141468310|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||ANOVA|||||||0.67
70980031|NCT00432809|141468310|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANOVA|||||||0.46
70980032|NCT00432809|141468311|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|||||||0.001
70980033|NCT00432809|141468311|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|||||||0.001
70980034|NCT00432809|141468311|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||ANOVA|||||||0.98
70980035|NCT00432809|141468312|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
70980036|NCT00432809|141468312|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.08
70980037|NCT00432809|141468312|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.17
70980038|NCT00432809|141468313|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
70980039|NCT00432809|141468313|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
70980040|NCT00432809|141468313|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.59
71035338|NCT00835263|141579511|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|102.14||||||90.0|100.06|104.26|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.26|100.06|
71035339|NCT01020474|141579544|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66||||0.121|TWO_SIDED|95.0|-1.51|0.18||Missing data for week 15 mean pain score are imputed based on distribution of baseline pain scores if participants discontinue due to adverse events/ abnormal laboratory test results or lack of efficacy.|ANCOVA|Based on LS Means using analysis of covariance (ANCOVA) model (including Treatment, Center, Baseline value as covariate).||||0.18|-1.51|0.121
71035340|NCT01020474|141579545|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.18||||0.655|TWO_SIDED|95.0|-1.0|0.63|||ANCOVA|Based on LS Means using analysis of covariance (ANCOVA) model (including Treatment, Center, Baseline value as covariate).||||0.63|-1.00|0.655
71035341|NCT01020474|141579546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07||||0.842|TWO_SIDED|95.0|-0.75|0.61|||Mixed Models Analysis|||Statistical analysis of Week 1.||0.61|-0.75|0.842
71035342|NCT01020474|141579546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63||||0.07|TWO_SIDED|95.0|-1.32|0.05|||Mixed Models Analysis|||Statistical analysis of Week 2||0.05|-1.32|0.070
71035343|NCT01020474|141579546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.83||||0.019|TWO_SIDED|95.0|-1.51|-0.14|||Mixed Models Analysis|||Statistical analysis of Week 3.||-0.14|-1.51|0.019
71096624|NCT01960842|141702171|SUPERIORITY_OR_OTHER||Mean change from score = 4|-2.0|STANDARD_DEVIATION|0.94|<|0.001|TWO_SIDED||||||Wilcoxon signed-rank test|||The p-value is based on a one-sample Wilcoxon signed-rank test with the hypothesis of no change (score = 4).||||<0.001
71096625|NCT01960842|141702172|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|||=|0.101|TWO_SIDED|95.0|-4.0|0.4|||One-sample t-test, 2-sided|||||0.4|-4.0|=0.101
71096626|NCT01960842|141702173|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.1|||=|0.182|TWO_SIDED|95.0|-5.3|1.1|||One-sample t-test, 2-sided|||||1.1|-5.3|=0.182
70980041|NCT00432809|141468314|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71035344|NCT01020474|141579546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.011|TWO_SIDED|95.0|-1.59|-0.21|||Mixed Models Analysis|||Statistical analysis of Week 4.||-0.21|-1.59|0.011
71035345|NCT01020474|141579546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68||||0.056|TWO_SIDED|95.0|-1.38|0.02|||Mixed Models Analysis|||Statistical analysis of Week 5.||0.02|-1.38|0.056
71035346|NCT01020474|141579546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.96||||0.008|TWO_SIDED|95.0|-1.66|-0.26|||Mixed Models Analysis|||Statistical analysis of Week 6.||-0.26|-1.66|0.008
71035347|NCT01020474|141579546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.89||||0.013|TWO_SIDED|95.0|-1.6|-0.19|||Mixed Models Analysis|||Statistical analysis of Week 7.||-0.19|-1.60|0.013
71035348|NCT01020474|141579546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.06||||0.004|TWO_SIDED|95.0|-1.77|-0.35|||Mixed Models Analysis|||Statistical analysis of Week 8.||-0.35|-1.77|0.004
71035349|NCT01020474|141579546|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.95||||0.009|TWO_SIDED|95.0|-1.67|-0.24|||Mixed Models Analysis|||Statistical analysis of Week 9.||-0.24|-1.67|0.009
71035350|NCT01020474|141579546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.97||||0.008|TWO_SIDED|95.0|-1.69|-0.25|||Mixed Models Analysis|||Statistical analysis of Week 10.||-0.25|-1.69|0.008
71035351|NCT01020474|141579546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.86||||0.021|TWO_SIDED|95.0|-1.59|-0.13|||Mixed Models Analysis|||Statistical analysis of Week 11.||-0.13|-1.59|0.021
71035352|NCT01020474|141579546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.97||||0.01|TWO_SIDED|95.0|-1.71|-0.23|||Mixed Models Analysis|||Statistical analysis of Week 12.||-0.23|-1.71|0.010
71035353|NCT01020474|141579546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74||||0.051|TWO_SIDED|95.0|-1.49|0.0|||Mixed Models Analysis|||Statistical analysis of Week 13.||0.00|-1.49|0.051
71096627|NCT01960842|141702174|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|||=|0.032|TWO_SIDED|95.0|-1.9|-0.09|||One-sample t-test, 2-sided|||||-0.09|-1.90|=0.032
71035354|NCT01020474|141579546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.02|TWO_SIDED|95.0|-1.66|-0.14|||Mixed Models Analysis|||Statistical analysis of Week 14.||-0.14|-1.66|0.020
71035355|NCT01020474|141579546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74||||0.06|TWO_SIDED|95.0|-1.51|0.03|||Mixed Models Analysis|||Statistical analysis of Week 15.||0.03|-1.51|0.060
71035356|NCT01020474|141579547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.21||||0.54|TWO_SIDED|95.0|-0.9|0.47|||Mixed Models Analysis|||Statistical analysis of Week 1.||0.47|-0.90|0.540
71035357|NCT01020474|141579547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19||||0.593|TWO_SIDED|95.0|-0.87|0.5|||Mixed Models Analysis|||Statistical analysis of Week 2||0.50|-0.87|0.593
71096628|NCT01960842|141702175|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.2|||<|0.001|TWO_SIDED|95.0|-27.8|-10.6|||One-sample t-test, 2-sided|||Mobility Domain analysis.||-10.6|-27.8|<0.001
71096629|NCT01960842|141702175|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.5|||=|0.059|TWO_SIDED|95.0|-13.3|0.3|||One-sample t-test, 2-sided|||Emotional Well-Being Domain analysis.||0.3|-13.3|=0.059
71096630|NCT01960842|141702175|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.5|||=|0.07|TWO_SIDED|95.0|-15.6|0.6|||One-sample t-test, 2-sided|||Stigma Domain analysis.||0.6|-15.6|=0.070
71096631|NCT01960842|141702175|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5|||=|0.591|TWO_SIDED|95.0|-7.3|4.2|||One-sample t-test, 2-sided|||Social Support Domain analysis.||4.2|-7.3|=0.591
70980042|NCT00432809|141468314|SUPERIORITY_OR_OTHER|||||||1.001||95.0|||||Chi-squared|||||||1.001
70980043|NCT00432809|141468314|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||Chi-squared|||||||0.68
70980044|NCT00432809|141468315|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
70980045|NCT00432809|141468315|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
70980046|NCT00432809|141468315|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||||||0.05
70980047|NCT00432809|141468316|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
70980048|NCT00432809|141468316|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
70980049|NCT00432809|141468316|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
71096632|NCT01960842|141702175|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.0|||<|0.001|TWO_SIDED|95.0|-20.7|-7.3|||One-sample t-test, 2-sided|||Cognition Domain analysis.||-7.3|-20.7|<0.001
71096633|NCT01960842|141702175|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|||=|0.67|TWO_SIDED|95.0|-4.2|6.4|||One-sample t-test, 2-sided|||Communication Domain analysis.||6.4|-4.2|=0.670
70980050|NCT00432809|141468317|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
70980051|NCT00432809|141468317|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Chi-squared|||||||0.005
70980052|NCT00432809|141468317|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared|||||||0.004
70980053|NCT00432809|141468318|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
70980054|NCT00432809|141468318|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
70980055|NCT00432809|141468318|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Chi-squared|||||||0.20
70980056|NCT00432809|141468319|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
70980057|NCT00432809|141468319|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
70980058|NCT00432809|141468319|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Chi-squared|||||||0.20
71035358|NCT01020474|141579547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44||||0.206|TWO_SIDED|95.0|-1.13|0.25|||Mixed Models Analysis|||Statistical analysis of Week 3.||0.25|-1.13|0.206
71035359|NCT01020474|141579547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49||||0.168|TWO_SIDED|95.0|-1.18|0.21|||Mixed Models Analysis|||Statistical analysis of Week 4.||0.21|-1.18|0.168
71035360|NCT01020474|141579547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38||||0.28|TWO_SIDED|95.0|-1.08|0.32|||Mixed Models Analysis|||Statistical analysis of Week 5.||0.32|-1.08|0.280
71035361|NCT01020474|141579547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64||||0.075|TWO_SIDED|95.0|-1.34|0.06|||Mixed Models Analysis|||Statistical analysis of Week 6.||0.06|-1.34|0.075
71035362|NCT01020474|141579547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.168|TWO_SIDED|95.0|-1.21|0.21|||Mixed Models Analysis|||Statistical analysis of Week 7.||0.21|-1.21|0.168
70980059|NCT00432809|141468320|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Chi-squared|||||||0.48
70980060|NCT00432809|141468320|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||Chi-squared|||||||0.46
70980061|NCT00432809|141468320|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
70980062|NCT00432809|141468321|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
70980063|NCT00432809|141468321|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
70980064|NCT00432809|141468321|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Chi-squared|||||||0.62
70980065|NCT00432809|141468322|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
70980066|NCT00432809|141468322|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
70980067|NCT00432809|141468322|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Chi-squared|||||||0.03
70980068|NCT01051739|141468325|SUPERIORITY_OR_OTHER|||||||0.21||||||The a priori threshold of statistical significance is p\<0.05|Kaplan Meyer survival curves|||||||.21
70980069|NCT00707577|141468326|SUPERIORITY||||||<|0.05|||||||Regression, Linear|random effects regression models for panel data adjusted for clustering within team||||||<0.05
70980070|NCT00064701|141468354|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|-1.9|||||TWO_SIDED|95.2|-8.9|5.2||||||||5.2|-8.9|
70980071|NCT00064701|141468354|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|-3.0|||||TWO_SIDED|95.2|-9.9|4.0||||||||4.0|-9.9|
70980072|NCT00064701|141468355|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|-3.3|||||TWO_SIDED|95.0|-7.2|0.6||||||||0.6|-7.2|
70980073|NCT00064701|141468355|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|0.0|||||TWO_SIDED|95.0|-3.1|3.2||||||||3.2|-3.1|
70980074|NCT00064701|141468356|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|-3.8|||||TWO_SIDED|95.0|-8.5|0.9||||||||0.9|-8.5|
70980075|NCT00064701|141468356|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|0.0|||||TWO_SIDED|95.0|-4.0|4.1||||||||4.1|-4.0|
70980076|NCT00064701|141468357|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference at 6 Months|-8.0|||||TWO_SIDED|95.0|-13.1|-3.0||||||Comparison of tacrolimus with cyclosporine at 6 months||-3.0|-13.1|
70980077|NCT00064701|141468357|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference at 6 Months|-3.8|||||TWO_SIDED|95.0|-9.5|1.8||||||Comparison of Tacrolimus Modified Release with Cyclosporine at 6 months||1.8|-9.5|
70980078|NCT00064701|141468357|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference at 12 Months|-6.1|||||TWO_SIDED|95.0|-12.0|-0.3||||||Comparison of tacrolimus with cyclosporine at 12 months||-0.3|-12.0|
70980079|NCT00064701|141468357|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference at 12 months|-3.4|||||TWO_SIDED|95.0|-9.6|2.8||||||Comparison of Tacrolimus Modified Release with Cyclosporine at 12 months||2.8|-9.6|
70980080|NCT00064701|141468367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-6.5|5.5||||||||5.5|-6.5|
70980081|NCT00064701|141468367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|||||TWO_SIDED|95.0|-3.9|6.9||||||||6.9|-3.9|
70980082|NCT00064701|141468368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-9.1|6.6||||||||6.6|-9.1|
70980083|NCT00064701|141468368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|||||TWO_SIDED|95.0|-7.1|8.6||||||||8.6|-7.1|
70980084|NCT02249052|141468369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-83.33|STANDARD_DEVIATION|25.0311|<|0.0001|TWO_SIDED|95.0|-95.394|-71.265|||t-test, 2 sided|||||-71.265|-95.394|<0.0001
71035363|NCT01020474|141579547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.01||||0.006|TWO_SIDED|95.0|-1.73|-0.3|||Mixed Models Analysis|||Statistical analysis of Week 8.||-0.30|-1.73|0.006
70980085|NCT02249052|141468370|SUPERIORITY_OR_OTHER||Binomial proportion|0.8947|||<|0.0001|TWO_SIDED|95.0|0.6686|0.987|||Sign test|||||.9870|.6686|<.0001
70980086|NCT02700451|141468397|EQUIVALENCE|Two-sided 95% confidence interval|||||<|0.001||||||Threshold for statistical significance was p = 0.05|Kruskal-Wallis|||The distribution of OME total in the first 72H is the same across these arms||||<0.001
70980087|NCT02700451|141468397|EQUIVALENCE|Two-sided 95% confidence interval|||||<|0.001||||||The thresholds for statistical significant was p = 0.05|Kruskal-Wallis|||The distribution of OME total to discharge is the same across these arms||||<0.001
70980088|NCT02700451|141468398|EQUIVALENCE|Two-sided||||||0.048|||||||Chi-squared|||Similar Distribution of opioid use between the 3 arms||||0.048
70980089|NCT02700451|141468399|EQUIVALENCE|Two-sided||||||0.595|||||||Chi-squared|||||||0.595
70980090|NCT02700451|141468402|EQUIVALENCE|Two-sided 95% confidence interval||||||0.732|||||||Kruskal-Wallis|||The distribution of POD1 - Current pain level is the same across the 3 arms||||0.732
70980091|NCT02700451|141468402|EQUIVALENCE|Two-sided 95% confidence interval||||||0.896|||||||Kruskal-Wallis|||The distribution of POD1 - Best pain level is the same across the 3 arms||||0.896
70980092|NCT02700451|141468402|EQUIVALENCE|Two-sided 95% confidence interval||||||0.004|||||||Kruskal-Wallis|||The distribution of POD1 - Worst pain level is the same across the 3 arms||||0.004
70980093|NCT02700451|141468402|EQUIVALENCE|Two-sided 95% confidence interval||||||0.325|||||||Kruskal-Wallis|||The distribution of POD3 - Current pain level is the same across the 3 arms||||0.325
70980094|NCT02700451|141468402|EQUIVALENCE|Two-sided 95% confidence interval||||||0.283|||||||Kruskal-Wallis|||The distribution of POD3 - Best pain level is the same across the 3 arms||||0.283
70980095|NCT02700451|141468402|EQUIVALENCE|Two-sided 95% confidence interval||||||0.61|||||||Kruskal-Wallis|||The distribution of POD3 - Worst pain level is the same across the 3 arms||||0.610
71035364|NCT01020474|141579547|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.57||||0.12|TWO_SIDED|95.0|-1.29|0.15|||Mixed Models Analysis|||Statistical analysis of Week 9.||0.15|-1.29|0.120
70980096|NCT02700451|141468403|EQUIVALENCE|Two-sided 95% confidence interval||||||0.016|||||||Kruskal-Wallis|||The distribution of POD1 - Pain has interfered with General Activity is the same across the 3 arms||||0.016
71035365|NCT01020474|141579547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.77||||0.037|TWO_SIDED|95.0|-1.49|-0.05|||Mixed Models Analysis|||Statistical analysis of Week 10.||-0.05|-1.49|0.037
71035366|NCT01020474|141579547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43||||0.246|TWO_SIDED|95.0|-1.16|0.3|||Mixed Models Analysis|||Statistical analysis of Week 11.||0.30|-1.16|0.246
71096634|NCT01960842|141702175|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.8|||<|0.001|TWO_SIDED|95.0|-25.2|-10.3|||One-sample t-test, 2-sided|||Bodily Discomfort Domain analysis.||-10.3|-25.2|<0.001
70980097|NCT02700451|141468403|EQUIVALENCE|Two-sided 95% confidence interval||||||0.294|||||||Kruskal-Wallis|||The distribution of POD1 - Pain has interfered with Mood is the same across the 3 arms||||0.294
70980098|NCT02700451|141468403|EQUIVALENCE|Two-sided 95% confidence interval||||||0.016|||||||Kruskal-Wallis|||The distribution of POD1 - Pain has interfered with Walking Ability is the same across the 3 arms||||0.016
70980099|NCT02700451|141468403|EQUIVALENCE|Two-sided 95% confidence interval||||||0.082|||||||Kruskal-Wallis|||The distribution of POD1 - Pain has interfered with Normal work is the same across the 3 arms||||0.082
70980100|NCT02700451|141468403|EQUIVALENCE|Two-sided 95% confidence interval||||||0.117|||||||Kruskal-Wallis|||The distribution of POD1 - Pain has interfered with Relation with other is the same across the 3 arms||||0.117
70980101|NCT02700451|141468403|EQUIVALENCE|Two-sided 95% confidence interval||||||0.061|||||||Fisher Exact|||The distribution of POD1 - Pain has interfered with Sleep is the same across the 3 arms||||0.061
70980102|NCT02700451|141468403|EQUIVALENCE|Two-sided 95% confidence interval||||||0.023|||||||Kruskal-Wallis|||The distribution of POD1 - Pain has interfered with Enjoyment of life is the same across the 3 arms||||0.023
70980103|NCT02700451|141468403|EQUIVALENCE|Two-sided 95% confidence interval||||||0.681|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with General Activity is the same across the 3 arms||||0.681
70980104|NCT02700451|141468403|EQUIVALENCE|Two-sided 95% confidence interval||||||0.405|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with Mood is the same across the 3 arms||||0.405
70980105|NCT02700451|141468403|EQUIVALENCE|Two-sided 95% confidence interval||||||0.458|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with Walking Ability is the same across the 3 arms||||0.458
70980106|NCT02700451|141468403|EQUIVALENCE|Two-sided 95% confidence interval||||||0.482|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with Normal work is the same across the 3 arms||||0.482
70980107|NCT02700451|141468403|EQUIVALENCE|Two-sided 95% confidence interval||||||0.544|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with Relation with other is the same across the 3 arms||||0.544
70980108|NCT02700451|141468403|EQUIVALENCE|Two-sided 95% confidence interval||||||0.202|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with Sleep is the same across the 3 arms||||0.202
70980109|NCT02700451|141468403|EQUIVALENCE|Two-sided 95% confidence interval||||||0.58|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with Enjoyment of life is the same across the 3 arms||||0.580
70980110|NCT02700451|141468405|EQUIVALENCE|Two-sided 95% confidence interval||||||0.928|||||||Kruskal-Wallis|||The distribution of Total Drain output at 24H is the same across the 3 arms||||0.928
70980111|NCT02700451|141468405|EQUIVALENCE|Two-sided 95% confidence interval||||||0.906|||||||Kruskal-Wallis|||The distribution of Total Drain output at 48H is the same across the 3 arms||||0.906
70980112|NCT02700451|141468405|EQUIVALENCE|Two-sided 95% confidence interval||||||0.926|||||||Kruskal-Wallis|||The distribution of Total Drain output at 72H is the same across the 3 arms||||0.926
70980113|NCT02700451|141468405|EQUIVALENCE|Two-sided 95% confidence interval||||||0.934|||||||Kruskal-Wallis|||The distribution of Total Drain output at Discharge is the same across the 3 arms||||0.934
70980114|NCT02700451|141468406|EQUIVALENCE|Two-sided||||||0.078|||||||Chi-squared|||Proportion of patient receiving at least 1 transfusion is the same across the 3 arms||||0.078
71035367|NCT01020474|141579547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.61||||0.105|TWO_SIDED|95.0|-1.36|0.13|||Mixed Models Analysis|||Statistical analysis of Week 12.||0.13|-1.36|0.105
71035368|NCT01020474|141579547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.34||||0.376|TWO_SIDED|95.0|-1.09|0.41|||Mixed Models Analysis|||Statistical analysis of Week 13.||0.41|-1.09|0.376
70980115|NCT02700451|141468407|EQUIVALENCE|Two-sided 95% confidence interval||||||792|||||||Chi-squared|||||||0792
70980116|NCT02700451|141468408|EQUIVALENCE|Two-sided 95% confidence interval||||||0.034|||||||Kruskal-Wallis|||The distribution of Length of stay in day is the same across these arms||||0.034
70980117|NCT02700451|141468408|EQUIVALENCE|Two-sided 95% confidence interval||||||0.03|||||||Kruskal-Wallis|||The distribution of Length of stay in hour is the same across these arms||||0.030
70980118|NCT02700451|141468409|EQUIVALENCE|Two-sided 95% confidence interval||||||0.974|||||||ANOVA|||Comparison of the PCS score between the 3 arms||||0.974
70980119|NCT02700451|141468409|EQUIVALENCE|Two-sided 95% confidence interval||||||0.444|||||||ANOVA|||Comparison of the MCS between the 3 ams||||0.444
70980120|NCT02700451|141468410|EQUIVALENCE|Two-sided 95% confidence interval||||||0.215|||||||ANOVA|||||||0.215
70980121|NCT02700451|141468411|EQUIVALENCE|Two-sided 95% confidence interval||||||0.044|||||||ANOVA|||Comparison PCS score between the 3 arms||||0.044
70980122|NCT02700451|141468411|EQUIVALENCE|Two-sided 95% confidence interval||||||0.767|||||||ANOVA|||Comparison MCS score between the 3 arms||||0.767
70980123|NCT02700451|141468412|EQUIVALENCE|Two-sided 95% confidence interval||||||0.191|||||||ANOVA|||||||0.191
70980124|NCT04373460|141468422|SUPERIORITY||Risk Difference (RD)|3.4||||0.005|TWO_SIDED|95.0|1.0|5.8|||Fisher Exact|||||5.8|1.0|0.005
70980125|NCT04373460|141468423|SUPERIORITY||Risk Difference (RD)|-0.05||||0.16|TWO_SIDED|95.0|-0.11|0.02|||Rate per person-years|||||0.02|-0.11|0.16
70980126|NCT04373460|141468424|SUPERIORITY||Incidence rate difference|0.18||||0.02|TWO_SIDED|95.0|0.03|0.32|||Rate per person-years|||||0.32|0.03|0.02
70980127|NCT04373460|141468425|SUPERIORITY||Risk Difference (RD)|0.01||||0.32|TWO_SIDED|95.0|-0.01|0.02|||Rate per person-years|||||0.02|-0.01|0.32
71035369|NCT01020474|141579547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41||||0.285|TWO_SIDED|95.0|-1.18|0.35|||Mixed Models Analysis|||Statistical analysis of Week 14.||0.35|-1.18|0.285
71035370|NCT01020474|141579547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17||||0.663|TWO_SIDED|95.0|-0.95|0.61|||Mixed Models Analysis|||Statistical analysis of Week 15.||0.61|-0.95|0.663
70980128|NCT04373460|141468430|SUPERIORITY|||||||0.65|||||||Fisher Exact|||||||0.65
70980129|NCT04373460|141468434|SUPERIORITY||Risk Ratio (RR)|0.525|||||TWO_SIDED|95.0|0.192|1.425||||||||1.425|0.192|
70980130|NCT02115308|141468452|SUPERIORITY|||||||0.001|||||||paired, t-test|non-adjusted||REST-TO-REGADENOSON STRESS||||0.001
70980131|NCT02115308|141468452|SUPERIORITY|||||||0.017||||||non-adjusted|paired, t-test|||REST-TO-REGADENOSON STRESS||||0.017
70980132|NCT02115308|141468452|SUPERIORITY|||||||0.495||||||non-adjusted|paired, t-test|||REST-TO-REGADENOSON STRESS||||0.495
70980133|NCT02115308|141468452|SUPERIORITY|||||||0.365|||||||t-test, 2 sided|non-adjusted||REST||||0.365
70980134|NCT02115308|141468452|SUPERIORITY|||||||0.602|||||||t-test, 2 sided|non adjusted||REST||||0.602
70980135|NCT02115308|141468452|SUPERIORITY|||||||0.915|||||||t-test, 2 sided|non adjusted||REST||||0.915
70980136|NCT02115308|141468452|SUPERIORITY|||||||0.033|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.033
70980137|NCT02115308|141468452|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.002
71096635|NCT01960842|141702176|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.8|||=|0.056|TWO_SIDED|95.0|-9.8|0.1|||One-sample t-test, 2-sided|||||0.1|-9.8|=0.056
70980138|NCT02115308|141468452|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.087
70980139|NCT02115308|141468452|SUPERIORITY|||||||0.399|||||||t-test, 2 sided|non adjusted||REST-TO-STRESS CHANGE||||0.399
70980140|NCT02115308|141468452|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|non adjusted||REST-TO-STRESS Change||||0.030
70980141|NCT02115308|141468452|SUPERIORITY|||||||0.048|||||||t-test, 2 sided|non adjusted||REST-TO-STRESS Change||||0.048
70980142|NCT02115308|141468453|SUPERIORITY|||||||0.011||||||Non-adjusted.|paired, t-test|||Rest VS Regadenoson Stress||||0.011
70980143|NCT02115308|141468453|SUPERIORITY|||||||0.003||||||non-adjusted|paired t-test|||Rest VS Regadenoson Stress||||0.003
70980144|NCT02115308|141468453|SUPERIORITY|non-adjusted||||||0.39|||||||paired, t-test|||Rest VS Regadenoson Stress||||0.390
70980145|NCT02115308|141468453|SUPERIORITY|non-adjusted|||||<|0|||||||t-test, 2 sided|||REST||||<0.000
70980146|NCT02115308|141468453|SUPERIORITY|non-adjusted|||||<|0|||||||t-test, 2 sided|||REST||||<0.000
70980147|NCT02115308|141468453|SUPERIORITY|non-adjusted||||||0.022|||||||t-test, 2 sided|||REST||||0.022
70980148|NCT02115308|141468453|SUPERIORITY|||||||0.001||||||non-adjusted|t-test, 2 sided|||Regadenoson STRESS||||0.001
70980149|NCT02115308|141468453|SUPERIORITY||||||<|0||||||non-adjusted|t-test, 2 sided|||Regadenoson STRESS||||<0.000
70980150|NCT02115308|141468453|SUPERIORITY|||||||0.006||||||non-adjusted|t-test, 2 sided|||Regadenoson STRESS||||0.006
70980151|NCT02115308|141468453|SUPERIORITY||||||<|0|||||||t-test, 2 sided|non-adjusted||REST-TO-STRESS Change||||<0.000
70980152|NCT02115308|141468453|SUPERIORITY|||||||0.058|||||||t-test, 2 sided|non-adjusted||REST-TO-STRESS Changes||||0.058
70980153|NCT02115308|141468453|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|non-adjusted||REST-TO-STRESS Change||||0.310
70980154|NCT02115308|141468454|SUPERIORITY|||||||0.001|||||||paired, t-test|non adjusted||REST vs STRESS||||0.001
70980155|NCT02115308|141468454|SUPERIORITY|||||||0.002|||||||paired, t-test|non adjusted||REST vs STRESS||||0.002
70980156|NCT02115308|141468454|SUPERIORITY|||||||0.721|||||||paired, t-test|non adjusted||REST vs STRESS||||0.721
70980157|NCT02115308|141468454|SUPERIORITY|||||||0.797|||||||t-test, 2 sided|non adjusted||REST||||0.797
70980158|NCT02115308|141468454|SUPERIORITY|||||||0.474|||||||t-test, 2 sided|non adjusted||REST||||0.474
70980159|NCT02115308|141468454|SUPERIORITY|||||||0.537|||||||t-test, 2 sided|non adjusted||||||0.537
70980160|NCT02115308|141468454|SUPERIORITY|||||||0.717|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.717
70980161|NCT02115308|141468454|SUPERIORITY|||||||0.041|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.041
71035371|NCT01020474|141579548|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87||||0.037|TWO_SIDED|95.0|-1.68|-0.05|||ANCOVA|Based on LS Means using analysis of covariance (ANCOVA) model (including Treatment, Center, Baseline value as covariate).||||-0.05|-1.68|0.037
71035372|NCT01020474|141579549|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17||||0.694|TWO_SIDED|95.0|0.53|2.58|||Regression, Logistic|||Statistical analysis at Week 15.||2.58|0.53|0.694
71096636|NCT01960842|141702177|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|||=|0.011|TWO_SIDED|95.0|-1.6|-0.2|||One-sample t-test, 2-sided|||||-0.2|-1.6|=0.011
71096637|NCT01960842|141702178|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2|||<|0.001|TWO_SIDED|95.0|-4.4|-1.9|||One-sample t-test, 2-sided|||||-1.9|-4.4|<0.001
71096638|NCT01960842|141702179|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.65|||<|0.001|TWO_SIDED|95.0|-5.83|-3.47|||One-sample t-test, 2-sided|||||-3.47|-5.83|<0.001
70980162|NCT02115308|141468454|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.050
70980163|NCT02115308|141468454|SUPERIORITY|||||||0.908||||||non adjusted|t-test, 2 sided|||REST-to-STRESS Change||||0.908
70980164|NCT02115308|141468454|SUPERIORITY|||||||0.233|||||||t-test, 2 sided|non adjusted||||||0.233
70980165|NCT02115308|141468454|SUPERIORITY|||||||0.187|||||||t-test, 2 sided|non adjusted||REST-to-STRESS Change||||0.187
70980166|NCT02115308|141468456|SUPERIORITY|||||||0.008|||||||paired, t-test|non adjusted||REST vs STRESS||||0.008
70980167|NCT02115308|141468456|SUPERIORITY|||||||0.006|||||||paired, t-test|non adjusted||REST vs STRESS||||0.006
70980168|NCT02115308|141468456|SUPERIORITY|||||||0.428|||||||paired, t-test|non adjusted||REST vs STRESS||||0.428
70980169|NCT02115308|141468456|SUPERIORITY||||||<|0|||||||t-test, 2 sided|non adjusted||REST||||<0.000
70980170|NCT02115308|141468456|SUPERIORITY||||||<|0|||||||t-test, 2 sided|non adjusted||REST||||<0.000
70980171|NCT02115308|141468456|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|non adjusted||REST||||0.006
70980172|NCT02115308|141468456|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.002
70980173|NCT02115308|141468456|SUPERIORITY||||||<|0|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||<0.000
70980174|NCT02115308|141468456|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.004
70980175|NCT02115308|141468456|SUPERIORITY||||||<|0|||||||t-test, 2 sided|non adjusted||REST-to-STRESS Change||||<0.000
70980176|NCT02115308|141468456|SUPERIORITY|||||||0.172|||||||t-test, 2 sided|non adjusted||REST-to-STRESS Change||||0.172
70980177|NCT02115308|141468456|SUPERIORITY|||||||0.957|||||||t-test, 2 sided|non adjusted||REST-to-STRESS Change||||0.957
70980178|NCT00642642|141468457|SUPERIORITY_OR_OTHER|||||||0.0109||95.0||||a priori threshold for statistical significance was 0.05|McNemar|Paired test of proportions||"Null hypothesis: no difference in the response rates between the two treatment arms.~Statistical test: McNemar's paired test of proportions Significance level: two sided alpha of 0.05 for each of the two co-primary endpoints.~Assumptions for power calculations:~Response rate for azficel-T treated cheek = 40% Response rate for placebo treated cheek = 20% 10% dropout rate; dropouts counted as failures. Low correlation between cheeks \& 50% correlation between endpoints"||||0.0109
70980179|NCT00642642|141468458|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||a priori threshold for statistical significance = 0.05|McNemar|paired test of proportions||"Null hypothesis: no difference in the response rates between the two treatment arms.~Statistical test: McNemar's paired test of proportions Significance level: two sided alpha of 0.05 for each of the two co-primary endpoints.~Assumptions for power calculations:~Response rate for azficel-T treated cheek = 40% Response rate for placebo treated cheek = 20% 10% dropout rate; dropouts counted as failures. Low correlation between cheeks \& 50% correlation between endpoints"||||<0.0001
71096639|NCT01960842|141702180|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.58|||<|0.001|TWO_SIDED|95.0|-5.73|-3.44|||One-sample t-test, 2-sided|||||-3.44|-5.73|<0.001
71096640|NCT02391584|141702189|SUPERIORITY||||||<|0.0001||||||p\<0.025 was considered significant.|t-test, 1 sided|||||||<0.0001
71096641|NCT02391584|141702193|SUPERIORITY||||||<|0.0001||||||Dunnett's t-test was used for the multiple comparisons with baseline. A p value \<0.05 was considered significant.|Mixed Models Analysis|||||||<0.0001
71096642|NCT02391584|141702194|SUPERIORITY||||||<|0.0001||||||Dunnett's t-test was used for the multiple comparisons with baseline. A p value \<0.05 was considered significant.|Mixed Models Analysis|||||||<0.0001
71096643|NCT02391584|141702195|SUPERIORITY||||||<|0.0001||||||Dunnett's t-test was used for the multiple comparisons with baseline. A p value \<0.05 was considered significant.|Mixed Models Analysis|||||||<0.0001
71096644|NCT02391584|141702196|SUPERIORITY||||||<|0.0001||||||Dunnett's t-test was used for the multiple comparisons with baseline. A p value \<0.05 was considered significant.|Mixed Models Analysis|||||||<0.0001
71096645|NCT03737032|141702203|SUPERIORITY|||||||0.8|||||||ANOVA|||Null hypothesis: post-TBS dmPFC activation will not vary by TBS condition. This is tested using the main effect of condition in a repeated measures model.||||0.80
71096646|NCT03737032|141702204|SUPERIORITY|||||||0.23|||||||ANOVA|Repeated measures ANOVA with time (pre or post), condition (cTBS, iTBS, sham TBS), and time\*condition effects.||Null hypothesis: pre-post change in positive affect will not vary by TBS condition. This is tested using the interaction of time\*condition in a repeated measures model.||||0.23
70980180|NCT02747004|141468489|SUPERIORITY|||||||0.293||||||Two-sided P-value.|Log Rank|Stratified by the randomization factors of presence of liver metastases and prior use of Tamoxifen in the advanced/metastatic setting.||||||0.2930
70980181|NCT02747004|141468489|OTHER|Informal phase 2 non-inferiority.|Hazard Ratio (HR)|1.045|||||TWO_SIDED|95.0|0.711|1.535|||Log Rank|Stratified by the randomization factors of presence of liver metastases and prior use of Tamoxifen in the advanced/metastatic setting.||||1.535|0.711|
70980182|NCT05087030|141468501|NON_INFERIORITY|The analysis was performed with an ANCOVA model with %CfB in lumbar spine BMD at Week 52 as the dependent variable, covariates were treatment arm (RGB-14-P and US-licensed Prolia).|Estimated Difference|0.18|||||TWO_SIDED|90.0|-0.465|0.826|||ANCOVA|||||0.826|-0.465|
70980183|NCT05087030|141468501|SUPERIORITY|Non-Superiority Test|Estimated Difference|0.55|||||TWO_SIDED|90.0|-0.099|1.191|||ANCOVA|||||1.191|-0.099|
70980184|NCT05087030|141468502|OTHER||Geometric mean ratio|1.01||||0.494|TWO_SIDED|95.0|0.978|1.046|||ANCOVA|||Comparison between Study Treatment Groups||1.046|0.978|0.494
70980185|NCT05087030|141468503|OTHER||Estimated difference|-0.31||||0.199|TWO_SIDED|95.0|-0.792|0.165|||Mixed model repeated measures|||at Week 26||0.165|-0.792|0.199
70980186|NCT05087030|141468503|OTHER||Estimated difference|-0.16||||0.543|TWO_SIDED|95.0|-0.68|0.358|||mixed model repeated measures|||At Week 52||0.358|-0.680|0.543
70980187|NCT05087030|141468504|OTHER||Estimated Difference|0.03||||0.929|TWO_SIDED|95.0|-0.703|0.769|||mixed model for repeated measures|||Week 26||0.769|-0.703|0.929
70980188|NCT01444300|141468514|SUPERIORITY_OR_OTHER|||||||0.51|||||||t-test, 2 sided|||t test comparing change in outcome between active and placebo||||0.51
70980189|NCT01444300|141468515|SUPERIORITY_OR_OTHER|||||||0.7|||||||t-test, 2 sided|||t test comparing change in outcome between active and placebo after 12 weeks.||||0.7
70980190|NCT01444300|141468516|SUPERIORITY_OR_OTHER|||||||0.8|||||||t-test, 2 sided|||t test comparing change in outcome between active and placebo||||0.8
70980191|NCT00963807|141468525|SUPERIORITY_OR_OTHER|||||||0.336|||||||t-test, 2 sided|||||||0.336
70980192|NCT00684177|141468528|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.4||||0.098|TWO_SIDED|95.0|-1.6|18.4|||Chi-squared|||||18.4|-1.6|0.098
70980193|NCT00684177|141468529|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.1||||0.04|TWO_SIDED|95.0|0.6|23.6|||Chi-squared|||||23.6|0.6|0.04
70980194|NCT00684177|141468530|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.1||||0.04|TWO_SIDED|95.0|0.6|23.6|||Chi-squared|||||23.6|0.6|0.04
71008527|NCT02140762|141525113|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|59.1|||||TWO_SIDED|||||||||Vaccine effectiveness \<100% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity strains in ABCWY)/(% of not killed strains/without bactericidal activity strains in ACWY)\*100\].||||
71008528|NCT02140762|141525114|SUPERIORITY_OR_OTHER||Vaccine effectiveness|44.0|||<|0.0001|TWO_SIDED|95.0|41.0|47.0|||General Linear Model (GLM)||VE is based on the relative risk (RR). The POISSON DISTRIBUTION and LOG LINK options was used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects: treatment group, strain (and center).|H0 (Null Hypothesis): Vaccine Effectiveness (VE) ≤10%. If the LL of the 95% CI for VE is \> 10% the null hypothesis is to be rejected and effectiveness declared. The VE at 4 months after the second injection for each strain is defined as \[1 - (% of subjects without bactericidal activity at 1:4 dilution in MenABCWY group / % of subjects without bactericidal activity at 1:4 dilution in MenACWY group)\] x 100.The combined VE across all strains will be computed by mean of a generalized linear model.||47|41|< 0.0001
71035373|NCT01020474|141579550|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.25||||0.162|TWO_SIDED|95.0|0.72|7.02|||Regression, Logistic|||Statistical analysis at Week 15.||7.02|0.72|0.162
71035374|NCT01020474|141579551|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013|||||||Cochran-Mantel-Haenszel|P-value uses the row mean score statistic based on Cochran Mantel Haenszel (CMH) test with modified ridit transformation.||Statistical analysis at Week 15.||||0.013
71008529|NCT02140762|141525114|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|9.1|||||TWO_SIDED|||||||||Vaccine effectiveness\<10% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:4 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
71008530|NCT02140762|141525114|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|22.7|||||TWO_SIDED|||||||||Vaccine effectiveness\<30% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:4 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
71008531|NCT02140762|141525114|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|19.1|||||TWO_SIDED|||||||||Vaccine effectiveness\<60% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:4 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
71035375|NCT03261167|141579559|OTHER||Difference|18.1|||||TWO_SIDED|95.0|1.1|35.0||||||||35.0|1.1|
71008532|NCT02140762|141525114|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|38.2|||||TWO_SIDED|||||||||Vaccine effectiveness\<100% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:4 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
71008772|NCT02055976|141525253|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-46.772|STANDARD_ERROR_OF_MEAN|3.473|<|0.001|TWO_SIDED|95.0|-53.671|-39.874|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-39.874|-53.671|<0.001
71035376|NCT03261167|141579560|OTHER||Adjusted rate difference|33.1|||||TWO_SIDED|95.0|17.0|49.2|||||Week 2, Elbow flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||49.2|17.0|
71035377|NCT03261167|141579560|OTHER||Adjusted rate difference|21.7|||||TWO_SIDED|95.0|4.9|38.5|||||Week 4, Elbow flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||38.5|4.9|
71035378|NCT03261167|141579560|OTHER||Adjusted rate difference|18.4|||||TWO_SIDED|95.0|1.3|35.5|||||Week 6, Elbow flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||35.5|1.3|
70980195|NCT01381094|141468549|SUPERIORITY||Mean Difference (Net)|0.8|||||TWO_SIDED|95.0|0.24|1.35||||||||1.35|0.24|
70980196|NCT01381094|141468549|SUPERIORITY||Mean Difference (Net)|0.76|||||TWO_SIDED|95.0|0.2|1.33||||||||1.33|0.20|
70980197|NCT01381094|141468549|SUPERIORITY||Mean Difference (Net)|1.28|||||TWO_SIDED|95.0|0.73|1.83||||||||1.83|0.73|
70980198|NCT01381094|141468549|SUPERIORITY||Mean Difference (Net)|1.45|||||TWO_SIDED|95.0|0.91|2.0||||||||2.00|0.91|
70980199|NCT01381094|141468549|SUPERIORITY||||||<|0.0001|TWO_SIDED||||||ANOVA|||||||<0.0001
71035379|NCT03261167|141579560|OTHER||Adjusted rate difference|12.9|||||TWO_SIDED|95.0|-4.2|30.1|||||Week 12, Elbow flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||30.1|-4.2|
71035380|NCT03261167|141579560|OTHER||Adjusted rate difference|-5.6|||||TWO_SIDED|95.0|-20.9|9.8|||||Week 2, Wrist flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||9.8|-20.9|
71035381|NCT03261167|141579560|OTHER||Adjusted rate difference|-8.6|||||TWO_SIDED|95.0|-23.0|5.9|||||Week 4, Wrist flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||5.9|-23.0|
71096647|NCT03737032|141702205|SUPERIORITY|||||||0.84|||||||ANOVA|||Null hypothesis: post-TBS functional connectivity between the dmPFC and ventral striatum (VS) will not vary by TBS condition. This is tested using the main effect of condition in a repeated measures model.||||0.84
71096648|NCT05156125|141702227|SUPERIORITY||Risk Difference (RD)|16.1||||0.0184|TWO_SIDED|95.0|2.58|29.05|||Cochran-Mantel-Haenszel|||At 13 weeks||29.05|2.58|0.0184
71096649|NCT05156125|141702227|SUPERIORITY||Risk Difference (RD)|13.1||||0.041|TWO_SIDED|95.0|-0.03|25.58|||Cochran-Mantel-Haenszel|||At 13 weeks||25.58|-0.03|0.0410
71096650|NCT05156125|141702228|SUPERIORITY||Risk Difference (RD)|20.6||||0.007|TWO_SIDED|95.0|5.73|34.42|||Cochran-Mantel-Haenszel|||At 13 weeks||34.42|5.73|0.0070
70980200|NCT01381094|141468550|SUPERIORITY||||||=|0.9355|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.9355
70980201|NCT01381094|141468550|SUPERIORITY||||||=|0.6594|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.6594
70980202|NCT01381094|141468550|SUPERIORITY||||||=|0.0203|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0203
70980203|NCT01381094|141468550|SUPERIORITY||||||=|0.0369|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0369
70980204|NCT01381094|141468550|SUPERIORITY|p-value was based on the comparison within treatment group (Change from Baseline to Week 1).|||||=|0.3713|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||||||=0.3713
71096651|NCT05156125|141702228|SUPERIORITY||Risk Difference (RD)|17.3||||0.0162|TWO_SIDED|95.0|2.75|30.67|||Cochran-Mantel-Haenszel|||At Week 13||30.67|2.75|0.0162
70980205|NCT01381094|141468550|SUPERIORITY||||||=|0.163|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.1630
70980206|NCT01381094|141468550|SUPERIORITY||||||=|0.7615|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.7615
70980207|NCT01381094|141468550|SUPERIORITY||||||=|0.004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0040
70980208|NCT01381094|141468550|SUPERIORITY||||||=|0.0003|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0003
70980209|NCT01381094|141468550|SUPERIORITY||||||=|0.3978|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.3978
71035382|NCT03261167|141579560|OTHER||Adjusted rate difference|-12.1|||||TWO_SIDED|95.0|-27.5|3.2|||||Week 6, Wrist flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||3.2|-27.5|
71035383|NCT03261167|141579560|OTHER||Adjusted rate difference|-9.6|||||TWO_SIDED|95.0|-27.2|7.9|||||Week 12, Wrist flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||7.9|-27.2|
71035384|NCT03261167|141579560|OTHER||Adjusted rate difference|-8.6|||||TWO_SIDED|95.0|-21.9|4.7|||||Week 2, Finger flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||4.7|-21.9|
71035385|NCT03261167|141579560|OTHER||Adjusted rate difference|-10.4|||||TWO_SIDED|95.0|-24.3|3.4|||||Week 4, Finger flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||3.4|-24.3|
71096652|NCT05156125|141702229|SUPERIORITY||Risk Difference (RD)|16.5||||0.0448|TWO_SIDED|95.0|0.65|31.37|||Cochran-Mantel-Haenszel|||||31.37|0.65|0.0448
71096653|NCT05156125|141702229|SUPERIORITY||Risk Difference (RD)|16.0||||0.0417|TWO_SIDED|95.0|0.23|30.58|||Cochran-Mantel-Haenszel|||At Week 13||30.58|0.23|0.0417
71096654|NCT05156125|141702230|SUPERIORITY||Risk Difference (RD)|11.5||||0.0499|TWO_SIDED|95.0|-0.99|23.38|||Cochran-Mantel-Haenszel|||||23.38|-0.99|0.0499
71096655|NCT05156125|141702230|SUPERIORITY||Risk Difference (RD)|21.4||||0.0011|TWO_SIDED|95.0|7.94|33.53|||Cochran-Mantel-Haenszel|||At Week 13||33.53|7.94|0.0011
71035386|NCT03261167|141579560|OTHER||Adjusted rate difference|-8.9|||||TWO_SIDED|95.0|-23.8|6.0|||||Week 6, Finger flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||6.0|-23.8|
71035387|NCT03261167|141579560|OTHER||Adjusted rate difference|-0.1|||||TWO_SIDED|95.0|-17.7|17.4|||||Week 12, Finger flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||17.4|-17.7|
71035388|NCT03261167|141579560|OTHER||Adjusted rate difference|-9.9|||||TWO_SIDED|95.0|-26.4|6.5|||||Week 2, Thumb flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||6.5|-26.4|
70922738|NCT02638337|141336596|SUPERIORITY||Odds Ratio (OR)|0.89||||0.6263|TWO_SIDED|95.0|0.55|1.43|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 4||1.43|0.55|0.6263
70922739|NCT02638337|141336596|SUPERIORITY||Odds Ratio (OR)|1.07||||0.7869|TWO_SIDED|95.0|0.66|1.75|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 8||1.75|0.66|0.7869
70922740|NCT02638337|141336596|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8894|TWO_SIDED|95.0|0.65|1.64|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 12||1.64|0.65|0.8894
70922741|NCT02638337|141336597|SUPERIORITY||Odds Ratio (OR)|0.92||||0.8369|TWO_SIDED|95.0|0.4|2.1|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 4||2.10|0.40|0.8369
70922742|NCT02638337|141336597|SUPERIORITY||Odds Ratio (OR)|1.51||||0.397|TWO_SIDED|95.0|0.58|3.95|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 8||3.95|0.58|0.3970
70922743|NCT02638337|141336597|SUPERIORITY||Odds Ratio (OR)|1.33||||0.5391|TWO_SIDED|95.0|0.54|3.26|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 12||3.26|0.54|0.5391
70922744|NCT02638337|141336598|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0095|TWO_SIDED|95.0|1.13|2.4|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 4||2.40|1.13|0.0095
70922745|NCT02638337|141336598|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0542|TWO_SIDED|95.0|0.99|2.11|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 8||2.11|0.99|0.0542
70922746|NCT02638337|141336598|SUPERIORITY||Odds Ratio (OR)|1.97||||0.0004|TWO_SIDED|95.0|1.35|2.88|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 12||2.88|1.35|0.0004
70922747|NCT02638337|141336599|SUPERIORITY||Odds Ratio (OR)|0.71||||0.4336|TWO_SIDED|95.0|0.3|1.67|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 4||1.67|0.30|0.4336
70922748|NCT02638337|141336599|SUPERIORITY||Odds Ratio (OR)|0.88||||0.7672|TWO_SIDED|95.0|0.37|2.08|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 8||2.08|0.37|0.7672
70922749|NCT02638337|141336599|SUPERIORITY||Odds Ratio (OR)|0.86||||0.7101|TWO_SIDED|95.0|0.39|1.89|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 12||1.89|0.39|0.7101
70922750|NCT02638337|141336600|SUPERIORITY||LS Mean Difference|13.98|||<|0.0001|TWO_SIDED|95.0|11.85|16.12|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 4||16.12|11.85|<0.0001
70922751|NCT02638337|141336600|SUPERIORITY||LS Mean Difference|14.73|||<|0.0001|TWO_SIDED|95.0|12.5|16.96|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 8||16.96|12.50|<0.0001
70922752|NCT02638337|141336600|SUPERIORITY||LS Mean Difference|14.91|||<|0.0001|TWO_SIDED|95.0|12.55|17.28|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 12||17.28|12.55|<0.0001
70922753|NCT02638337|141336601|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Week 4||||<0.0001
70922754|NCT02638337|141336601|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Week 8||||<0.0001
70922755|NCT02638337|141336601|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Week 12||||<0.0001
71035389|NCT03261167|141579560|OTHER||Adjusted rate difference|-6.7|||||TWO_SIDED|95.0|-23.6|10.3|||||Week 4, Thumb flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||10.3|-23.6|
71035390|NCT03261167|141579560|OTHER||Adjusted rate difference|-1.5|||||TWO_SIDED|95.0|-18.8|15.7|||||Week 6, Thumb flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||15.7|-18.8|
71035391|NCT03261167|141579560|OTHER||Adjusted rate difference|-0.5|||||TWO_SIDED|95.0|-18.8|17.9|||||Week 12, Thumb flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||17.9|-18.8|
71096656|NCT05156125|141702231|SUPERIORITY|||||||0.0072|||||||Cochran-Mantel-Haenszel|||At Week 13||||0.0072
71035392|NCT03261167|141579561|OTHER||Mean Difference (Net)|-0.48|||||TWO_SIDED|95.0|-0.75|-0.22|||||Week 2, Elbow flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||-0.22|-0.75|
70980210|NCT01381094|141468550|SUPERIORITY||||||=|0.0083|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0083
70980211|NCT01381094|141468550|SUPERIORITY||||||=|0.0323|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0323
70980212|NCT01381094|141468550|SUPERIORITY||||||=|0.0003|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0003
70980213|NCT01381094|141468550|SUPERIORITY||||||=|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0001
71035393|NCT03261167|141579561|OTHER||Mean Difference (Net)|-0.42|||||TWO_SIDED|95.0|-0.71|-0.13|||||Week 4, Elbow flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||-0.13|-0.71|
71035394|NCT03261167|141579561|OTHER||Mean Difference (Net)|-0.37|||||TWO_SIDED|95.0|-0.71|-0.04|||||Week 6, Elbow flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||-0.04|-0.71|
71035395|NCT03261167|141579561|OTHER||Mean Difference (Net)|-0.27|||||TWO_SIDED|95.0|-0.51|-0.02|||||Week 12, Elbow flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||-0.02|-0.51|
71035396|NCT03261167|141579561|OTHER||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-0.27|0.42|||||Week 2, Wrist flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.42|-0.27|
71035397|NCT03261167|141579561|OTHER||Mean Difference (Net)|0.11|||||TWO_SIDED|95.0|-0.25|0.46|||||Week 4, Wrist flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.46|-0.25|
71096657|NCT05156125|141702231|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||At Week 13||||<0.0001
70980214|NCT01381094|141468550|SUPERIORITY||||||=|0.423|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.4230
71096658|NCT05075772|141702240|OTHER||Ratio of gMeans (%)|46.3|||||TWO_SIDED|90.0|38.3|55.9|||||"Ratio of Geometric Least Squares Means (gMeans) was calculated as (gMean of SC injection (T))/(gMean of IV infusion (R)).~Intra-matched-pair geometric coefficient of variation=28.2."|The statistical model used for the analysis of this primary endpoint was an analysis of variance (ANOVA). The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included a fixed effect for treatment assignment and a random effect for matching pair (each matched pair in the study was assigned a number for the analysis).||55.9|38.3|
70980215|NCT01381094|141468550|SUPERIORITY||||||=|0.0023|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0023
70980216|NCT01381094|141468550|SUPERIORITY||||||=|0.0009|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0009
71035398|NCT03261167|141579561|OTHER||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.37|0.33|||||Week 6, Wrist flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.33|-0.37|
71035399|NCT03261167|141579561|OTHER||Mean Difference (Net)|0.09|||||TWO_SIDED|95.0|-0.19|0.38|||||Week 12, Wrist flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.38|-0.19|
71035400|NCT03261167|141579561|OTHER||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.23|0.43|||||Week 2, Finger flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.43|-0.23|
71096659|NCT05075772|141702241|OTHER||Ratio of gMeans (%)|26.8|||||TWO_SIDED|90.0|23.2|31.1|||||"Ratio of Geometric Least Squares Means (gMeans) was calculated as (gMean of SC injection (T))/(gMean of IV infusion (R)). Intra-matched-pair geometric coefficient of variation=22.5"|The statistical model used for the analysis of this primary endpoint was an analysis of variance (ANOVA). The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included a fixed effect for treatment assignment and a random effect for matching pair (each matched pair in the study was assigned a number for the analysis).||31.1|23.2|
71035401|NCT03261167|141579561|OTHER||Mean Difference (Net)|0.17|||||TWO_SIDED|95.0|-0.17|0.52|||||Week 4, Finger flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.52|-0.17|
71035402|NCT03261167|141579561|OTHER||Mean Difference (Net)|-0.14|||||TWO_SIDED|95.0|-0.2|0.48|||||Week 6, Finger flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interaction, Baseline, and Baseline by visit interaction as fixed effects.|||0.48|-0.20|
71035403|NCT03261167|141579561|OTHER||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-0.25|0.34|||||Week 12, Finger flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interaction, Baseline, and Baseline by visit interaction as fixed effects.|||0.34|-0.25|
71096660|NCT05075772|141702242|OTHER||Ratio of gMeans (%)|47.0|||||TWO_SIDED|90.0|39.0|56.6|||||"Ratio of Geometric Least Squares Means (gMeans) was calculated as (gMean of SC injection (T))/(gMean of IV infusion (R)).~Intra-matched-pair geometric coefficient of variation=27.7."|The statistical model used for the analysis of this secondary endpoint was an analysis of variance (ANOVA). The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included a fixed effect for treatment assignment and a random effect for matching pair (each matched pair in the study was assigned a number for the analysis).||56.6|39.0|
70922756|NCT02638337|141336602|SUPERIORITY||LS Mean Difference|2.5|||<|0.0001|TWO_SIDED|95.0|2.0|3.0|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 4||3.0|2.0|<0.0001
70922757|NCT02638337|141336602|SUPERIORITY||LS Mean Difference|2.9|||<|0.0001|TWO_SIDED|95.0|2.4|3.4|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 8||3.4|2.4|<0.0001
70922758|NCT02638337|141336602|SUPERIORITY||LS Mean Difference|2.8|||<|0.0001|TWO_SIDED|95.0|2.2|3.4|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 12||3.4|2.2|<0.0001
71035404|NCT03261167|141579561|OTHER||Mean Difference (Net)|0.28|||||TWO_SIDED|95.0|-0.08|0.63|||||Week 2, Thumb flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.63|-0.08|
71035405|NCT03261167|141579561|OTHER||Mean Difference (Net)|0.14|||||TWO_SIDED|95.0|-0.23|0.51|||||Week 4, Thumb flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.51|-0.23|
71035406|NCT03261167|141579561|OTHER||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.33|0.38|||||Week 6, Thumb flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.38|-0.33|
71035407|NCT03261167|141579561|OTHER||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-0.31|0.47|||||Week 12, Thumb flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.47|-0.31|
71035408|NCT03261167|141579562|OTHER||Mean Difference (Net)|-0.24|||||TWO_SIDED|95.0|-0.48|0.0|||||Week 2. Analysis method was MMRM with Treatment, Visit, Treatment by visit interaction, Baseline, and Baseline by visit interaction as fixed effects.|||0.00|-0.48|
71035409|NCT03261167|141579562|OTHER||Mean Difference (Net)|-0.16|||||TWO_SIDED|95.0|-0.42|0.09|||||Week 4. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.09|-0.42|
71035410|NCT03261167|141579562|OTHER||Mean Difference (Net)|-0.15|||||TWO_SIDED|95.0|-0.37|0.08|||||Week 6. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.08|-0.37|
71035411|NCT03261167|141579562|OTHER||Mean Difference (Net)|-0.28|||||TWO_SIDED|95.0|-0.52|-0.04|||||Week 12. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||-0.04|-0.52|
71035412|NCT00835146|141579572|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.9||||||90.0|91.8|105.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||105|91.8|
71035413|NCT00835146|141579573|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.3||||||90.0|93.3|106.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106|93.3|
71035414|NCT00466167|141579581|SUPERIORITY_OR_OTHER||Adjusted mean difference from placebo|4.9|STANDARD_ERROR_OF_MEAN|1.3||0.0001|TWO_SIDED|95.0|2.4|7.4|||ANCOVA|||ANCOVA with factors treatment, pooled country and covariate baseline||7.4|2.4|0.0001
71035415|NCT00466167|141579581|SUPERIORITY_OR_OTHER||Adjusted mean difference from placebo|6.6|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|4.2|9.1|||ANCOVA|||ANCOVA with factors treatment, pooled country and covariate baseline||9.1|4.2|<.0001
71035416|NCT00466167|141579582|SUPERIORITY_OR_OTHER||Adjusted mean difference from Placebo|4.5|STANDARD_ERROR_OF_MEAN|1.8||0.0122|TWO_SIDED|95.0|1.0|7.9|||ANCOVA|||ANCOVA with factors treatment, pooled country and covariate baseline||7.9|1.0|0.0122
71035417|NCT00466167|141579582|SUPERIORITY_OR_OTHER||Adjusted mean difference from placebo|7.1|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|TWO_SIDED|95.0|3.7|10.5|||ANCOVA|||ANCOVA with factors treatment, pooled country and covariate baseline||10.5|3.7|<.0001
71035418|NCT02927639|141579603|SUPERIORITY|"A subject was considered completed if they completed all 3 SCI (as indicated in participant flow section) - 13 control, 10 intervention.~However, the mixed model took in to account ALL available data. As such, there were 70 control, 65 intervention that completed at least 1 SCI. Their data was analyzed by the model and used to predict later outcomes so they were considered to be included in the analysis."||||||0.035||||||The mixed model may provide a significantly different change in SCI score from baseline to the 6 month using a per-protocol analysis in the intervention group as compared to the control group. A p value \<0.05 was considered significant.|Mixed Models Analysis|||A multilevel mixed effects linear regression model was used to analyze this data. This analysis allowed for an estimation of missing data. This explains the discrepancy in the number of participant study completion vs participant data analyzed (see below).||||0.035
71035419|NCT02450539|141579609|SUPERIORITY||Hazard Ratio (HR)|1.765||||0.0068|TWO_SIDED|95.0|1.165|2.672|||Stratified log-rank test.||Stratified Cox proportional hazard model|Stratified by baseline ECOG performance status (0 vs 1), number of Prior Therapies (received only platinum-based therapy vs Received platinum-based Therapy plus Immune Checkpoint Inhibitor), and time since initiation of first line therapy (\<=9 months vs \>9 months).||2.672|1.165|0.0068
71035420|NCT02450539|141579612|SUPERIORITY||Hazard Ratio (HR)|1.333||||0.1746|TWO_SIDED|95.0|0.879|2.022|||Stratified log-rank test||Stratified Cox proportional hazard model|Stratified by baseline ECOG performance status (0 vs 1), number of Prior Therapies (received only platinum-based therapy vs Received platinum-based Therapy plus Immune Checkpoint Inhibitor), and time since initiation of first line therapy (\<=9 months vs \>9 months).\]||2.022|0.879|0.1746
71096661|NCT02993302|141702251|OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
71096662|NCT02993302|141702252|OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
70980217|NCT01381094|141468550|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
70980218|NCT01381094|141468550|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
70980219|NCT01381094|141468550|SUPERIORITY||||||=|0.5291|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.5291
70980220|NCT01381094|141468550|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0002
70980221|NCT01381094|141468550|SUPERIORITY||||||=|0.0222|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0222
70980222|NCT01381094|141468550|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0002
71096663|NCT02993302|141702253|OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
71096664|NCT01755637|141702258|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%|Geometric mean Ratio of treatments|114.37|||||TWO_SIDED|90.0|100.49|130.16|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||130.16|100.49|
71096665|NCT01755637|141702259|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%|Geometric mean ratio of treatments|107.41|||||TWO_SIDED|90.0|69.03|167.13|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||167.13|69.03|
71096666|NCT01755637|141702260|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range of 70% -143%.|Geometric mean ratio of treatments|111.28|||||TWO_SIDED|90.0|94.76|130.68|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||130.68|94.76|
71096667|NCT01755637|141702261|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0167||||0.0011||95.0|||||Wilcoxon signed rank test|The values were not adjusted for this non-parametric analysis.|The median difference was calculated as = (Experimental-Reference)|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.0011
71096668|NCT01755637|141702262|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%|Geometric mean ratio of treatments|112.05|||||TWO_SIDED|90.0|103.65|121.12|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||121.12|103.65|
71096669|NCT01755637|141702263|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%|Geometric mean ratio of treatments|113.1|||||TWO_SIDED|90.0|103.4|123.71|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||123.71|103.40|
70980223|NCT01381094|141468550|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0002
70980224|NCT01381094|141468550|SUPERIORITY||||||=|0.9314|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.9314
70980225|NCT01381094|141468551|SUPERIORITY||||||=|0.5219|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.5219
70980226|NCT01381094|141468551|SUPERIORITY||||||=|0.6743|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.6743
70980227|NCT01381094|141468551|SUPERIORITY||||||=|0.0078|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0078
70980228|NCT01381094|141468551|SUPERIORITY||||||=|0.0301|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0301
70980229|NCT01381094|141468551|SUPERIORITY||||||=|0.4502|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.4502
70980230|NCT01381094|141468551|SUPERIORITY||||||=|0.6967|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.6967
70980231|NCT01381094|141468551|SUPERIORITY||||||=|0.7385|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.7385
70980232|NCT01381094|141468551|SUPERIORITY||||||=|0.0176|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0176
70980233|NCT01381094|141468551|SUPERIORITY||||||=|0.0057|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0057
70980234|NCT01381094|141468551|SUPERIORITY||||||=|0.5551|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.5551
70980235|NCT01381094|141468551|SUPERIORITY||||||=|0.0086|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0086
70980236|NCT01381094|141468551|SUPERIORITY||||||=|0.2385|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.2385
71096670|NCT01755637|141702264|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range of 70% -143%.|Geometric mean ratio of treatments|114.33|||||TWO_SIDED|90.0|102.99|126.93|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||126.93|102.99|
71096671|NCT04098302|141702301|SUPERIORITY|||||||0.012|||||||Mixed Models Analysis|||||||0.012
70980237|NCT01381094|141468551|SUPERIORITY||||||=|0.0007|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0007
70980238|NCT01381094|141468551|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0002
70980239|NCT01381094|141468551|SUPERIORITY||||||=|0.8895|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.8895
70980240|NCT01381094|141468551|SUPERIORITY||||||=|0.0127|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0127
70980241|NCT01381094|141468551|SUPERIORITY||||||=|0.0076|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0076
70980242|NCT01381094|141468551|SUPERIORITY||||||=|0.0007|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0007
71096672|NCT04098302|141702302|SUPERIORITY|||||||0.019|||||||Mixed Models Analysis|||||||0.019
71096673|NCT04098302|141702303|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71096674|NCT04098302|141702304|SUPERIORITY|||||||0.29|||||||Mixed Models Analysis|||||||0.29
71096675|NCT01810952|141702318|SUPERIORITY_OR_OTHER|||||||0.35||||||This is the p-value for Day 5|t-test, 2 sided|||||||0.35
70980243|NCT01381094|141468551|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
70980244|NCT01381094|141468551|SUPERIORITY||||||=|0.5522|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.5522
70980245|NCT01381094|141468551|SUPERIORITY||||||=|0.0031|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0031
70980246|NCT01381094|141468551|SUPERIORITY||||||=|0.2188|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.2188
70980247|NCT01381094|141468551|SUPERIORITY||||||=|0.0054|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0054
70980248|NCT01381094|141468551|SUPERIORITY||||||=|0.0037|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0037
70980249|NCT01381094|141468551|SUPERIORITY||||||=|0.9521|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.9521
70980250|NCT01381094|141468552|SUPERIORITY||||||=|0.3943|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.3943
70980251|NCT01381094|141468552|SUPERIORITY||||||=|0.2096|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.2096
70980252|NCT01381094|141468552|SUPERIORITY||||||=|0.0637|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0637
70980253|NCT01381094|141468552|SUPERIORITY||||||=|0.5016|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.5016
70980254|NCT01381094|141468552|SUPERIORITY||||||=|0.7549|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.7549
70980255|NCT01381094|141468552|SUPERIORITY||||||=|0.5991|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.5991
70980256|NCT01381094|141468552|SUPERIORITY||||||=|0.4258|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.4258
70980257|NCT01381094|141468552|SUPERIORITY||||||=|0.0336|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0336
70980258|NCT01381094|141468552|SUPERIORITY||||||=|0.0258|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0258
70980259|NCT01381094|141468552|SUPERIORITY||||||=|0.2412|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.2412
71035421|NCT02450539|141579613|SUPERIORITY||Rate Difference|-17.9|||||TWO_SIDED|95.0|-29.3|-6.6|||||Confidence intervals are based on the normal approximation to the binomial.|||-6.6|-29.3|
71035422|NCT02450539|141579614|SUPERIORITY||Rate Difference|-13.2|||||TWO_SIDED|95.0|-29.2|2.8|||||Confidence intervals are based on the normal approximation to the binomial.|||2.8|-29.2|
71096676|NCT01810952|141702319|SUPERIORITY_OR_OTHER|||||||0.65|||||||Chi-squared|||||||0.65
71035423|NCT02450539|141579615|SUPERIORITY||Hazard Ratio (HR)|1.184||||0.7039|TWO_SIDED|95.0|0.502|2.792|||Stratified Log Rank||Stratified Cox regression model.|Stratification factors are baseline ECOG performance status (0 vs 1), Number of Prior Therapies (received only platinum-based therapy vs Received platinum-based Therapy plus Immune Checkpoint Inhibitor), and time since initiation of first line therapy (\<=9 months vs \>9 months).||2.792|0.502|0.7039
70980260|NCT01381094|141468552|SUPERIORITY||||||=|0.0031|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0031
70980261|NCT01381094|141468552|SUPERIORITY||||||=|0.7705|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.7705
70980262|NCT01381094|141468552|SUPERIORITY||||||=|0.0024|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0024
70980263|NCT01381094|141468552|SUPERIORITY||||||=|0.0006|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0006
70980264|NCT01381094|141468552|SUPERIORITY||||||=|0.6189|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.6189
70980265|NCT01381094|141468552|SUPERIORITY||||||=|0.0075|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0075
70980266|NCT01381094|141468552|SUPERIORITY||||||=|0.0259|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0259
70980267|NCT01381094|141468552|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
70980268|NCT01381094|141468552|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
70980269|NCT01381094|141468552|SUPERIORITY||||||=|0.8898|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.8898
70980270|NCT01381094|141468552|SUPERIORITY||||||=|0.001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0010
70980271|NCT01381094|141468552|SUPERIORITY||||||=|0.2864|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.2864
70980272|NCT01381094|141468552|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0002
70980273|NCT01381094|141468552|SUPERIORITY||||||=|0.0016|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0016
70980274|NCT01381094|141468552|SUPERIORITY||||||=|0.9697|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.9697
70980275|NCT01381094|141468553|SUPERIORITY||||||=|1|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=1.0000
70980276|NCT01381094|141468553|SUPERIORITY||||||=|0.0055|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0055
71035424|NCT02450539|141579616|SUPERIORITY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|||||||||Headache||||
71035425|NCT02450539|141579616|SUPERIORITY||Mean Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|||||||||Diarrhea||||
71035426|NCT02450539|141579616|SUPERIORITY||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|||||||||Mean core symptom severity||||
71035427|NCT02450539|141579616|SUPERIORITY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|||||||||Mean interference||||
71035428|NCT02450539|141579616|SUPERIORITY||Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|||||||||Mean lung cancer symptom severity||||
70980277|NCT01381094|141468553|SUPERIORITY||||||=|0.0009|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0009
71035429|NCT02450539|141579616|SUPERIORITY||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|||||||||Mean core plus lung cancer symptom severity||||
70922759|NCT02638337|141336603|SUPERIORITY||LS Mean Difference|-0.8||||0.0002|TWO_SIDED|95.0|-1.3|-0.4|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 4||-0.4|-1.3|0.0002
70922760|NCT02638337|141336603|SUPERIORITY||LS Mean Difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.6|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 8||-0.6|-1.5|<0.0001
70922761|NCT02638337|141336603|SUPERIORITY||LS Mean Difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.7|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 12||-0.7|-1.6|<0.0001
70922762|NCT02638337|141336604|SUPERIORITY||LS Mean Difference|-1.0||||0.0118|TWO_SIDED|95.0|-1.8|-0.2|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-0.2|-1.8|0.0118
70922763|NCT02638337|141336605|SUPERIORITY||LS Mean Difference|0.02||||0.9748|TWO_SIDED|95.0|-1.17|1.2|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 4||1.20|-1.17|0.9748
70922764|NCT02638337|141336605|SUPERIORITY||LS Mean Difference|0.19||||0.7865|TWO_SIDED|95.0|-1.18|1.56|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 8||1.56|-1.18|0.7865
70922765|NCT02638337|141336605|SUPERIORITY||LS Mean Difference|1.59||||0.0392|TWO_SIDED|95.0|0.08|3.09|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 12||3.09|0.08|0.0392
70922766|NCT02638337|141336606|SUPERIORITY||LS Mean Difference|0.16||||0.0752|TWO_SIDED|95.0|-0.02|0.34|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Desire||0.34|-0.02|0.0752
70922767|NCT02638337|141336606|SUPERIORITY||LS Mean Difference|0.2||||0.1867|TWO_SIDED|95.0|-0.1|0.49|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Arousal||0.49|-0.10|0.1867
70922768|NCT02638337|141336606|SUPERIORITY||LS Mean Difference|0.4||||0.0161|TWO_SIDED|95.0|0.07|0.73|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Lubrication||0.73|0.07|0.0161
70922769|NCT02638337|141336606|SUPERIORITY||LS Mean Difference|0.16||||0.34|TWO_SIDED|95.0|-0.16|0.48|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Orgasm||0.48|-0.16|0.3400
70922770|NCT02638337|141336606|SUPERIORITY||LS Mean Difference|0.16||||0.2195|TWO_SIDED|95.0|-0.1|0.41|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Satisfaction||0.41|-0.10|0.2195
70922771|NCT02638337|141336606|SUPERIORITY||LS Mean Difference|0.45||||0.0103|TWO_SIDED|95.0|0.11|0.8|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Pain||0.80|0.11|0.0103
70922772|NCT02638337|141336607|SUPERIORITY||LS Mean Difference|0.1||||0.723|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 4||0.6|-0.4|0.7230
70922773|NCT02638337|141336607|SUPERIORITY||LS Mean Difference|0.4||||0.1104|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 8||0.9|-0.1|0.1104
70922774|NCT02638337|141336607|SUPERIORITY||LS Mean Difference|0.3||||0.2448|TWO_SIDED|95.0|-0.2|0.9|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 12||0.9|-0.2|0.2448
70922775|NCT02638337|141336608|SUPERIORITY||LS Mean Difference|-4388.3||||0.4263|TWO_SIDED|95.0|-15214.8|6438.3|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||6438.3|-15214.8|0.4263
70922776|NCT02638337|141336609|SUPERIORITY||LS Mean Difference|-0.049|||<|0.0001|TWO_SIDED|95.0|-0.071|-0.027|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-0.027|-0.071|<0.0001
70922777|NCT02638337|141336610|SUPERIORITY||LS Mean Difference|-0.14||||0.5159|TWO_SIDED|95.0|-0.58|0.29|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||0.29|-0.58|0.5159
70922778|NCT02638337|141336611|SUPERIORITY||LS Mean Difference|-0.75||||0.0227|TWO_SIDED|95.0|-1.39|-0.1|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-0.10|-1.39|0.0227
70922779|NCT02638337|141336612|SUPERIORITY||LS Mean Difference|-0.22||||0.0003|TWO_SIDED|95.0|-0.34|-0.1|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-0.10|-0.34|0.0003
70922780|NCT02638337|141336613|SUPERIORITY||LS Mean Difference|-6.2|||<|0.0001|TWO_SIDED|95.0|-8.1|-4.3|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-4.3|-8.1|<0.0001
70922781|NCT02638337|141336614|SUPERIORITY||LS Mean Difference|-1.35||||0.0084|TWO_SIDED|95.0|-2.35|-0.35|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-0.35|-2.35|0.0084
70922782|NCT02638337|141336615|SUPERIORITY||LS Mean Difference|-2.06|||<|0.0001|TWO_SIDED|95.0|-2.92|-1.19|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-1.19|-2.92|<0.0001
70922783|NCT02638337|141336616|SUPERIORITY||LS Mean Difference|-5.26|||<|0.0001|TWO_SIDED|95.0|-7.64|-2.89|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-2.89|-7.64|<0.0001
70922784|NCT02638337|141336617|SUPERIORITY|||||||0.9575|||||||Welch's t-test|||||||0.9575
70922785|NCT02638337|141336618|SUPERIORITY|||||||0.8772|||||||Welch's t-test|||||||0.8772
70922786|NCT02638337|141336619|SUPERIORITY|||||||0.0007|||||||Wilcoxon rank-sum test|||||||0.0007
70922787|NCT03338816|141336658|SUPERIORITY||Rate ratio|0.26|||<|0.0001|TWO_SIDED|95.0|0.16|0.41||P=6.040E-09|Negative binomial regression model|||Negative binomial regression model with treatment group and stratification factors (prior hemin prophylaxis status and historical attack rates) as fixed effects and the logarithm of the follow-up time as an offset variable.||0.41|0.16|<0.0001
71035430|NCT02450539|141579616|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|||||||||Mean brain tumor symptom severity||||
71035431|NCT02450539|141579616|SUPERIORITY||Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|||||||||Mean core plus lung worst 5 symptoms severity||||
71035432|NCT02450539|141579616|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|||||||||Rash||||
70980278|NCT01381094|141468553|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0002
70980279|NCT01381094|141468553|SUPERIORITY||||||=|0.9722|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.9722
70980280|NCT01381094|141468553|SUPERIORITY||||||=|1|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=1.0000
70980281|NCT01381094|141468553|SUPERIORITY||||||=|0.0008|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0008
70980282|NCT01381094|141468553|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0002
70980283|NCT01381094|141468553|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||<0.0001
70980284|NCT01381094|141468553|SUPERIORITY||||||=|0.6579|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.6579
70980285|NCT01381094|141468553|SUPERIORITY||||||=|0.4102|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.4102
71035433|NCT02450539|141579617|SUPERIORITY||Mean Difference (Final Values)|-3.13|STANDARD_ERROR_OF_MEAN|2.07|||TWO_SIDED|||||||||EQ VAS Overall Self-rated Health Score||||
71035434|NCT02450539|141579618|SUPERIORITY||Median Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|||||||||EQ-5D-5L Index Value||||
71035435|NCT01640197|141579619|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
70980286|NCT01381094|141468553|SUPERIORITY||||||=|0.0023|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0023
70980287|NCT01381094|141468553|SUPERIORITY||||||=|0.0052|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0052
70980288|NCT01381094|141468553|SUPERIORITY||||||=|0.0017|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0017
70980289|NCT01381094|141468553|SUPERIORITY||||||=|0.7378|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.7378
71035436|NCT01640197|141579620|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
71035437|NCT01640197|141579621|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
71035438|NCT01640197|141579622|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
71035439|NCT01640197|141579623|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
71035440|NCT01640197|141579624|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
71035441|NCT01640197|141579625|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
71035442|NCT00115063|141579672|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71035443|NCT00115063|141579673|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71035444|NCT00115063|141579674|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||P-value for systolic blood pressure mean.|t-test, 2 sided|||||||0.09
71035445|NCT00115063|141579674|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||P-value for dystolic blood pressure mean.|t-test, 2 sided|||||||0.60
71035446|NCT00115063|141579675|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||P-value for LDL cholesterol|t-test, 2 sided|||||||0.73
71035447|NCT00115063|141579675|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value for HDL cholesterol|t-test, 2 sided|||||||0.01
71035448|NCT00115063|141579675|SUPERIORITY_OR_OTHER|||||||0.42||95.0||||P-value for triglycerides|t-test, 2 sided|||||||0.42
71035449|NCT00115063|141579675|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value for uric acid|t-test, 2 sided|||||||0.05
71035450|NCT00115063|141579676|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||t-test, 2 sided|||||||0.16
71035451|NCT00115063|141579677|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||||||0.001
71096677|NCT01810952|141702320|SUPERIORITY_OR_OTHER|||||||0.06||||||Comparison of the 5 day averages resulted in a p-value of 0.06.|t-test, 2 sided|||Daily values for each protocol were compared using t-tests.||||0.06
71096678|NCT01810952|141702321|SUPERIORITY_OR_OTHER||difference in binomial proportions|||||0.795||||||Comparison of the number of participants in each group with glucose value \<70 mg/dL resulted in p-value 0.795.|Chi-squared|||||||0.795
70980290|NCT01381094|141468553|SUPERIORITY||||||=|0.3371|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.3371
70980291|NCT01381094|141468553|SUPERIORITY||||||=|0.0916|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0916
70980292|NCT01381094|141468553|SUPERIORITY||||||=|0.4656|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.4656
70980293|NCT01381094|141468553|SUPERIORITY||||||=|0.1629|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.1629
70980294|NCT01381094|141468553|SUPERIORITY||||||=|0.7032|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.7032
70980295|NCT01381094|141468553|SUPERIORITY||||||=|0.5194|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.5194
70980296|NCT01381094|141468553|SUPERIORITY||||||=|0.8516|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.8516
70980297|NCT01381094|141468553|SUPERIORITY||||||=|0.0017|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0017
70980298|NCT01381094|141468553|SUPERIORITY||||||=|0.0656|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0656
70980299|NCT01381094|141468553|SUPERIORITY||||||=|0.6495|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.6495
70980300|NCT01381094|141468554|SUPERIORITY||||||=|0.2065|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.2065
70980301|NCT01381094|141468554|SUPERIORITY||||||=|0.1807|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.1807
71035452|NCT01075282|141579687|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.45|||<|0.001|TWO_SIDED|95.0|-0.6|-0.29||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||The study was designed with 90% power to detect non-inferiority of LY2189265 1.5 mg vs insulin glargine on HbA1c change from baseline at the 52-week primary endpoint with a margin of 0.4%, a standard deviation of 1.3%, and a 1-sided alpha of 0.025 assuming no true difference between treatments. This corresponds to 223 participants per arm, with an assumed drop-out rate of 20%.||-0.29|-0.60|<0.001
70980302|NCT01381094|141468554|SUPERIORITY||||||=|0.7869|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.7869
70980303|NCT01381094|141468554|SUPERIORITY||||||=|0.4743|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.4743
70980304|NCT01381094|141468554|SUPERIORITY||||||=|0.6407|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.6407
70980305|NCT01381094|141468555|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
70980306|NCT01381094|141468555|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0002
70980307|NCT01381094|141468555|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
71035453|NCT01075282|141579687|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.13|||<|0.001|TWO_SIDED|95.0|-0.29|0.02||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||0.02|-0.29|<0.001
71035454|NCT01075282|141579687|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.45|||<|0.001|TWO_SIDED|95.0|-0.6|-0.29||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.29|-0.60|<0.001
71035455|NCT01075282|141579687|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13||||0.05|TWO_SIDED|95.0|-0.29|0.02||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||0.02|-0.29|0.05
70980308|NCT01381094|141468555|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
70980309|NCT01381094|141468555|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
70980310|NCT01381094|141468556|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0002
70980311|NCT01381094|141468556|SUPERIORITY||||||=|0.0004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0004
70980312|NCT01381094|141468556|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0002
70980313|NCT01381094|141468556|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
70980314|NCT01381094|141468556|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0002
70980315|NCT01381094|141468557|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
70980316|NCT01381094|141468557|SUPERIORITY||||||=|0.0043|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0043
70980317|NCT01381094|141468557|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
70980318|NCT01381094|141468557|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
71035456|NCT01075282|141579688|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.51|||<|0.001|TWO_SIDED|95.0|-0.65|-0.37||Treatment comparison at 26 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.37|-0.65|<0.001
70980319|NCT01381094|141468557|SUPERIORITY||||||=|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0001
70980320|NCT01381094|141468558|SUPERIORITY||||||=|0.0027|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0027
70980321|NCT01381094|141468558|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
70980322|NCT01381094|141468558|SUPERIORITY||||||=|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0001
70980323|NCT01381094|141468558|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
70980324|NCT01381094|141468558|SUPERIORITY||||||=|0.0005|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0005
70980325|NCT01381094|141468564|SUPERIORITY||||||=|0.6051|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.6051
71096679|NCT01810952|141702322|SUPERIORITY_OR_OTHER|||||||0.055||||||Comparison between groups of percent of glucose values \>180 mg/dL.|Chi-squared|||Values in each group were compared by Chi squared.||||0.055
71035457|NCT01075282|141579688|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.24|||<|0.001|TWO_SIDED|95.0|-0.38|-0.1||Treatment comparison at 26 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.10|-0.38|<0.001
71035458|NCT01075282|141579688|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.51|||<|0.001|TWO_SIDED|95.0|-0.65|-0.37||Treatment comparison at 26 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.37|-0.65|<0.001
71035459|NCT01075282|141579688|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|||<|0.001|TWO_SIDED|95.0|-0.38|-0.1||Treatment comparison at 26 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.10|-0.38|<0.001
71035460|NCT01075282|141579688|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.5|-0.13||Treatment comparison at 78 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.13|-0.50|<0.001
71035461|NCT01075282|141579688|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.03|||<|0.001|TWO_SIDED|95.0|-0.21|0.15||Treatment comparison at 78 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||0.15|-0.21|<0.001
71035462|NCT01075282|141579688|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.5|-0.13||Treatment comparison at 78 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.13|-0.50|<0.001
70980326|NCT01381094|141468564|SUPERIORITY||||||=|0.5197|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.5197
70980327|NCT01381094|141468564|SUPERIORITY||||||=|0.1073|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.1073
70980328|NCT01381094|141468564|SUPERIORITY||||||=|0.1321|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.1321
70980329|NCT01381094|141468564|SUPERIORITY||||||=|0.4358|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.4358
70980330|NCT01381094|141468564|SUPERIORITY||||||=|0.8109|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.8109
71035463|NCT01075282|141579688|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.378|TWO_SIDED|95.0|-0.21|0.15||Treatment comparison at 78 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||0.15|-0.21|0.378
71035464|NCT01075282|141579689|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.61|||<|0.001|TWO_SIDED|95.0|2.98|7.11||Treatment comparison at 26 weeks.|Regression, Logistic|||||7.11|2.98|<0.001
71035465|NCT01075282|141579689|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13|||<|0.001|TWO_SIDED|95.0|1.41|3.24||Treatment comparison at 26 weeks.|Regression, Logistic|||||3.24|1.41|<0.001
71035466|NCT01075282|141579689|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.76|||<|0.001|TWO_SIDED|95.0|2.45|5.75||Treatment comparison at 52 weeks.|Regression, Logistic|||||5.75|2.45|<0.001
71035467|NCT01075282|141579689|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.098|TWO_SIDED|95.0|0.94|2.15||Treatment comparison at 52 weeks.|Regression, Logistic|||||2.15|0.94|0.098
71035468|NCT01075282|141579689|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.77|||<|0.001|TWO_SIDED|95.0|1.85|4.14||Treatment comparison at 78 weeks.|Regression, Logistic|||||4.14|1.85|<0.001
70980331|NCT01381094|141468564|SUPERIORITY||||||=|0.2575|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.2575
70980332|NCT01381094|141468564|SUPERIORITY||||||=|0.8361|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.8361
71035469|NCT01075282|141579689|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.334|TWO_SIDED|95.0|0.82|1.82||Treatment comparison at 78 weeks.|Regression, Logistic|||||1.82|0.82|0.334
71035470|NCT01075282|141579690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.7|||<|0.001|TWO_SIDED|95.0|2.9|7.63||Treatment comparison at 26 weeks.|Regression, Logistic|||||7.63|2.90|<0.001
71035471|NCT01075282|141579690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.54|||<|0.001|TWO_SIDED|95.0|1.57|4.11||Treatment comparison at 26 weeks.|Regression, Logistic|||||4.11|1.57|<0.001
71035472|NCT01075282|141579690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.97|||<|0.001|TWO_SIDED|95.0|1.81|4.85||Treatment comparison at 52 weeks.|Regression, Logistic|||||4.85|1.81|<0.001
71035473|NCT01075282|141579690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.07||||0.004|TWO_SIDED|95.0|1.26|3.39||Treatment comparison at 52 weeks.|Regression, Logistic|||||3.39|1.26|0.004
70980333|NCT01381094|141468564|SUPERIORITY||||||=|0.0294|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0294
70980334|NCT01381094|141468564|SUPERIORITY||||||=|0.8809|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.8809
70980335|NCT01381094|141468564|SUPERIORITY||||||=|0.4971|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.4971
70980336|NCT01381094|141468564|SUPERIORITY||||||=|0.3994|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.3994
70980337|NCT01381094|141468564|SUPERIORITY||||||=|0.5022|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.5022
70980338|NCT01381094|141468564|SUPERIORITY||||||=|0.9916|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.9916
70980339|NCT01381094|141468564|SUPERIORITY||||||=|0.2292|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.2292
70980340|NCT01381094|141468564|SUPERIORITY||||||=|0.1331|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.1331
70980341|NCT01381094|141468564|SUPERIORITY||||||=|0.5518|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.5518
70980342|NCT01381094|141468564|SUPERIORITY||||||=|0.9032|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.9032
70980343|NCT01381094|141468564|SUPERIORITY||||||=|0.2387|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.2387
70980344|NCT01381094|141468564|SUPERIORITY||||||=|0.4251|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.4251
70980345|NCT01381094|141468565|SUPERIORITY||||||=|0.0448|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0448
71035474|NCT01075282|141579690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.27|||<|0.001|TWO_SIDED|95.0|1.44|3.57||Treatment comparison at 78 weeks.|Regression, Logistic|Treatment comparison at 78 weeks.||||3.57|1.44|<0.001
70980346|NCT01381094|141468565|SUPERIORITY||||||=|0.0004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0004
71035475|NCT01075282|141579690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.073|TWO_SIDED|95.0|0.96|2.42||Treatment comparison at 78 weeks.|Regression, Logistic|||||2.42|0.96|0.073
71035476|NCT01075282|141579691|SUPERIORITY_OR_OTHER|||||||0.109||||||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||||0.109
71035477|NCT01075282|141579691|SUPERIORITY_OR_OTHER|||||||0.335||||||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||||0.335
71035478|NCT01075282|141579691|SUPERIORITY_OR_OTHER|||||||0.091||||||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||||0.091
71035479|NCT01075282|141579691|SUPERIORITY_OR_OTHER|||||||0.4||||||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||||0.400
71035480|NCT01075282|141579691|SUPERIORITY_OR_OTHER|||||||0.641||||||Treatment comparison at 78 weeks.|Mixed Models Analysis|||||||0.641
71035481|NCT01075282|141579691|SUPERIORITY_OR_OTHER|||||||0.055||||||Treatment comparison at 78 weeks.|Mixed Models Analysis|||||||0.055
71035482|NCT01075282|141579694|SUPERIORITY_OR_OTHER||LS Mean Difference|2.83|||<|0.001|TWO_SIDED|95.0|2.33|3.33||Treatment comparison at 26 weeks.|ANCOVA|||||3.33|2.33|<0.001
71035483|NCT01075282|141579694|SUPERIORITY_OR_OTHER||LS Mean Difference|2.48|||<|0.001|TWO_SIDED|95.0|1.99|2.99||Treatment comparison at 26 weeks.|ANCOVA|||||2.99|1.99|<0.001
71035484|NCT01075282|141579694|SUPERIORITY_OR_OTHER||LS Mean Difference|3.31|||<|0.001|TWO_SIDED|95.0|2.71|3.9||Treatment comparison at 52 weeks.|ANCOVA|||||3.90|2.71|<0.001
71035485|NCT01075282|141579694|SUPERIORITY_OR_OTHER||LS Mean Difference|2.77|||<|0.001|TWO_SIDED|95.0|2.17|3.36||Treatment comparison at 52 weeks.|ANCOVA|||||3.36|2.17|<0.001
71035486|NCT01075282|141579694|SUPERIORITY_OR_OTHER||LS Mean Difference|3.24|||<|0.001|TWO_SIDED|95.0|2.59|3.89||Treatment comparison at 78 weeks.|ANCOVA|||||3.89|2.59|<0.001
71035487|NCT01075282|141579694|SUPERIORITY_OR_OTHER||LS Mean Difference|2.82|||<|0.001|TWO_SIDED|95.0|2.17|3.46||Treatment comparison at 78 weeks.|ANCOVA|||||3.46|2.17|<0.001
70980347|NCT01381094|141468565|SUPERIORITY||||||=|0.0813|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0813
70980348|NCT01381094|141468565|SUPERIORITY||||||=|0.0038|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0038
70980349|NCT01381094|141468565|SUPERIORITY||||||=|0.6861|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.6861
70980350|NCT01381094|141468565|SUPERIORITY||||||=|0.0553|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0553
70980351|NCT01381094|141468565|SUPERIORITY||||||=|0.0004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0004
70980352|NCT01381094|141468565|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||<0.0001
70980353|NCT01381094|141468565|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||<0.0001
70980354|NCT01381094|141468565|SUPERIORITY||||||=|0.7379|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.7379
70980355|NCT01381094|141468565|SUPERIORITY||||||=|0.072|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0720
70980356|NCT01381094|141468565|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0002
71035488|NCT02571907|141579741|OTHER||||||||||||||||||A Bayesian beta-binomial model with a Uniform(0, 1) prior was used to compute a 95% credible interval for the proportion of patients meeting the primary endpoint. The lower bound of this credible interval (2.5th percentile of the posterior distribution) was 91.2%, which was greater than the performance goal of 55%.|||
71035489|NCT02571907|141579742|OTHER||||||||||||||||||A Bayesian beta-binomial model with a Uniform(0, 1) prior was used to compute a 95% credible interval for the proportion of patients meeting the secondary endpoint. The lower bound of this credible interval (2.5th percentile of the posterior distribution) was 70.8%, which was greater than the performance goal of 46%.|||
70980357|NCT01381094|141468565|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
71035490|NCT03666026|141579748|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|1.0|1.03||||||||1.03|1.00|
71035491|NCT03666026|141579748|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|1.0|1.04||||||||1.04|1.00|
70980358|NCT01381094|141468565|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
70980359|NCT01381094|141468565|SUPERIORITY||||||=|0.6781|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.6781
70980360|NCT01381094|141468565|SUPERIORITY||||||=|0.0524|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0524
71035492|NCT03666026|141579748|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|1.0|1.04||||||||1.04|1.00|
71035493|NCT01343004|141579764|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71035494|NCT01343004|141579764|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71035495|NCT01343004|141579765|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
71035496|NCT01343004|141579765|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
71035497|NCT01343004|141579765|SUPERIORITY_OR_OTHER|||||||0.8155|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||0.8155
71035498|NCT01343004|141579766|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
71035499|NCT01343004|141579766|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
70980361|NCT01381094|141468565|SUPERIORITY||||||=|0.0367|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0367
70980362|NCT01381094|141468565|SUPERIORITY||||||=|0.6671|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.6671
70980363|NCT01381094|141468565|SUPERIORITY||||||=|0.6861|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.6861
71035500|NCT01343004|141579766|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
71035501|NCT01343004|141579767|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
71035502|NCT01343004|141579767|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
71035503|NCT01343004|141579767|SUPERIORITY_OR_OTHER|||||||0.0004|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||0.0004
71035504|NCT01343004|141579768|SUPERIORITY_OR_OTHER|||||||0.0318|||||||Chi-squared|||||||0.0318
71035505|NCT01343004|141579768|SUPERIORITY_OR_OTHER|||||||0.2304|||||||Chi-squared|||||||0.2304
71035506|NCT01343004|141579768|SUPERIORITY_OR_OTHER|||||||0.3361|||||||Chi-squared|||||||0.3361
71035507|NCT00526188|141579780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.46||||||95.0|6.0|12.93|||Test performed based on the 95% CI||Comparison was post-contrast MRI minus pre-contrast MRI|Difference in sensitivity of lesion detection between post- and pre-contrast MRI image set was calculated. Null hypothesis: No difference between post- and pre-contrast MRI image set. Test was performed based on a normal-approximated confidence interval (CI) for the average blinded reader difference. This CI had a confidence level of 95% and was two-sided. The study was planned with a power of 80%.||12.93|6.00|
71035508|NCT00526188|141579781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.81||||||95.0|1.84|7.78|||Test performed based on the 95% CI||Comparison was post-contrast MRI minus pre-contrast MRI (for investigator's result)|Difference in sensitivity of lesion detection between post- and pre-contrast MRI image sets, based on investigators assessments was calculated. Null hypothesis: No difference between post and pre contrast MRI image set. Test was performed based on a normal-approximated confidence interval (CI) for the investigators difference. This CI had a confidence level of 95% and was two-sided.||7.78|1.84|
71035509|NCT00526188|141579782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.36||||||95.0|7.45|15.28|||Test performed based on the 95% CI||Comparison was combined pre- and post-contrast MRI minus pre-contrast MRI|Difference in precision of lesion characterization between combined pre and post contrast MRI and pre contrast MRI image set was calculated. Null hypothesis: No difference between combined pre- and post-contrast MRI and pre contrast MRI image set. Test was performed based on a normal-approximated confidence interval (CI) for the average blinded reader difference. This CI had a confidence level of 95% and was two-sided.||15.28|7.45|
71035510|NCT00830258|141579798|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|105.76||||||90.0|98.17|113.93|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||113.93|98.17|
71035511|NCT00830258|141579799|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|110.45||||||90.0|104.31|116.96|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||116.96|104.31|
71035512|NCT00830258|141579800|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|110.61||||||90.0|104.39|117.2|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||117.20|104.39|
71035513|NCT04590027|141579849|NON_INFERIORITY|power calculation was not recorded Definition of non inferiority: two point difference of pain score at the measurement times|||||<|0.05|||||||ANCOVA|To rule out confounders due to an age difference, the ANCOVA test was applied to compare the differences in pain scores age-unrelatedly.|||Fisher Yates Test to compare the requirement of resue medication|||<0.05
71035514|NCT04590027|141579850|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
71096680|NCT01668537|141702344|NON_INFERIORITY|The non-inferiority margin to show that the FD formulation is non-inferior to the LF formulation in terms of ELISA GMTs at the peak visit (Week 6) was predefined as '1.5' for the GMT ratio (LF/FD). Non-inferiority is demonstrated if the upper 95% CI of the GMT ratio (LF/FD) is entirely below 1.5|GMT ratio (LF/FD)|0.796|||||TWO_SIDED|95.0|0.707|0.896||||||||0.896|0.707|
70980364|NCT01381094|141468565|SUPERIORITY||||||=|0.9012|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.9012
71035515|NCT03437265|141579872|OTHER||||||||||||||||||PK parameters were estimated for each subject by non-compartmental analysis methods using Phoenix® WinNonlin® software (v8.0, Certara USA, Inc., USA). Summary statistics (n, mean, SD, CV%, median, minimum, maximum, geometric n, geometric mean (geometric SD) and geometric CV%) were presented.|||
71035516|NCT03437265|141579873|OTHER||||||||||||||||||PK parameters were estimated for each subject by non-compartmental analysis methods using Phoenix® WinNonlin® software (v8.0, Certara USA, Inc., USA). Summary statistics (n, mean, SD, CV%, median, minimum, maximum, geometric n, geometric mean (geometric SD) and geometric CV%) were presented.|||
71096681|NCT05064800|141702362|OTHER||Ratio of Adjusted Geometric Means|233.06|||||TWO_SIDED|90.0|172.14|315.54|||Mixed Models Analysis|||Treatment 1 was Reference and Treatment 2 was Test. Natural log-transformed Cmax of dabigatran was analyzed using mixed effect model with treatment, period, sequence as fixed effects; participant within sequence as a random effect. Estimates of the adjusted mean differences(AMD) (Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||315.54|172.14|
71096682|NCT05064800|141702363|OTHER||Ratio of Adjusted Geometric Means|169.07|||||TWO_SIDED|90.0|135.25|211.35|||Mixed Models Analysis|||Treatment 1 was Reference and Treatment 2 was Test. Natural log-transformed AUCinf of dabigatran was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences(AMD)(Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means(Test/Reference) and 90%CI for the ratios.||211.35|135.25|
71096683|NCT05064800|141702364|OTHER||Ratio of Adjusted Geometric Means|160.05|||||TWO_SIDED|90.0|119.19|214.9|||Mixed Models Analysis|||Treatment 1 was Reference and Treatment 2 was Test. Natural log-transformed AUClast of dabigatran was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences(AMD)(Test-Reference) and 90%CIs were obtained from the model.The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means(Test/Reference) and 90%CI for the ratios.||214.90|119.19|
70980365|NCT01381094|141468566|SUPERIORITY||||||=|0.3953|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.3953
70980366|NCT01381094|141468566|SUPERIORITY||||||=|0.085|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0850
70980367|NCT01381094|141468566|SUPERIORITY||||||=|0.6045|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.6045
70980368|NCT01381094|141468566|SUPERIORITY||||||=|0.7743|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.7743
70980369|NCT01381094|141468566|SUPERIORITY||||||=|0.5326|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.5326
70980370|NCT01381094|141468566|SUPERIORITY||||||=|0.3465|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.3465
70980371|NCT01381094|141468566|SUPERIORITY||||||=|0.2756|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.2756
70980372|NCT01381094|141468566|SUPERIORITY||||||=|0.1414|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.1414
70980373|NCT01381094|141468566|SUPERIORITY||||||=|0.6941|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.6941
70980374|NCT01381094|141468566|SUPERIORITY||||||=|0.9403|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.9403
70980375|NCT01381094|141468566|SUPERIORITY||||||=|0.831|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.8310
70980376|NCT01381094|141468566|SUPERIORITY||||||=|0.0654|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0654
70980377|NCT01381094|141468566|SUPERIORITY||||||=|0.4169|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.4169
70980378|NCT01381094|141468566|SUPERIORITY||||||=|0.0103|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0103
70980379|NCT01381094|141468566|SUPERIORITY||||||=|0.3968|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.3968
71096684|NCT05064800|141702365|OTHER||Ratio of Adjusted Geometric Means|171.91|||||TWO_SIDED|90.0|127.51|231.77|||Mixed Models Analysis|||Treatment 1 was Reference and Treatment 3 was Test. Natural log-transformed Cmax of dabigatran was analyzed using mixed effect model with treatment, period, sequence as fixed effects; participant within sequence as a random effect. Estimates of the adjusted mean differences(AMD) (Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||231.77|127.51|
71096685|NCT05064800|141702366|OTHER||Ratio of Adjusted Geometric Means|169.07|||||TWO_SIDED|90.0|135.25|211.35|||Mixed Models Analysis|||Treatment 1 was Reference and Treatment 3 was Test. Natural log-transformed AUCinf of dabigatran was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences(AMD)(Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means(Test/Reference) and 90%CI for the ratios.||211.35|135.25|
70980380|NCT01381094|141468566|SUPERIORITY||||||=|0.0325|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0325
70980381|NCT01381094|141468566|SUPERIORITY||||||=|0.2151|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.2151
70980382|NCT01381094|141468566|SUPERIORITY||||||=|0.8436|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.8436
70980383|NCT01381094|141468566|SUPERIORITY||||||=|0.5962|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.5962
70980384|NCT01381094|141468566|SUPERIORITY||||||=|0.3957|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.3957
70980385|NCT01381094|141468567|SUPERIORITY||||||=|0.0294|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0294
70980386|NCT01381094|141468567|SUPERIORITY||||||=|0.0021|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0021
70980387|NCT01381094|141468567|SUPERIORITY||||||=|0.0004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0004
70980388|NCT01381094|141468567|SUPERIORITY||||||=|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0001
70980389|NCT01381094|141468567|SUPERIORITY||||||=|0.0925|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0925
71035517|NCT03437265|141579874|OTHER||||||||||||||||||PK parameters were estimated for each subject by non-compartmental analysis methods using Phoenix® WinNonlin® software (v8.0, Certara USA, Inc., USA). Summary statistics (n, mean, SD, CV%, median, minimum, maximum, geometric n, geometric mean (geometric SD) and geometric CV%) were presented.|||
71096686|NCT05064800|141702367|OTHER||Ratio of Adjusted Geometric Means|160.05|||||TWO_SIDED|90.0|119.19|214.9|||Mixed Models Analysis|||Treatment 1 was Reference and Treatment 3 was Test. Natural log-transformed AUClast of dabigatran was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences(AMD)(Test-Reference) and 90%CIs were obtained from the model.The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means(Test/Reference) and 90%CI for the ratios.||214.90|119.19|
71096687|NCT04477486|141702382|SUPERIORITY|Comparing against a historical reference of 12.5% CRR.|||||<|0.001|||||||Exact Binomial Distribution|||||||<0.001
70980390|NCT01381094|141468567|SUPERIORITY||||||=|0.0433|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0433
70980391|NCT01381094|141468567|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||<0.0001
70980392|NCT01381094|141468567|SUPERIORITY||||||=|0.0005|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0005
71035518|NCT03437265|141579875|OTHER||||||||||||||||||PK parameters were estimated for each subject by non-compartmental analysis methods using Phoenix® WinNonlin® software (v8.0, Certara USA, Inc., USA). Summary statistics (n, mean, SD, CV%, median, minimum, maximum, geometric n, geometric mean (geometric SD) and geometric CV%) were presented.|||
71035519|NCT03437265|141579876|OTHER||||||||||||||||||PK parameters were estimated for each subject by non-compartmental analysis methods using Phoenix® WinNonlin® software (v8.0, Certara USA, Inc., USA). Summary statistics (n, mean, SD, CV%, median, minimum, maximum, geometric n, geometric mean (geometric SD) and geometric CV%) were presented.|||
70980393|NCT01381094|141468567|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||<0.0001
70980394|NCT01381094|141468567|SUPERIORITY||||||=|0.1626|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.1626
70980395|NCT01381094|141468567|SUPERIORITY||||||=|0.0366|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0366
70980396|NCT01381094|141468567|SUPERIORITY||||||=|0.0004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0004
70980397|NCT01381094|141468567|SUPERIORITY||||||=|0.0012|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0012
70980398|NCT01381094|141468567|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
70980399|NCT01381094|141468567|SUPERIORITY||||||=|0.1779|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.1779
70980400|NCT01381094|141468567|SUPERIORITY||||||=|0.5867|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.5867
70980401|NCT01381094|141468567|SUPERIORITY||||||=|0.1306|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.1306
70980402|NCT01381094|141468567|SUPERIORITY||||||=|0.9889|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.9889
70980403|NCT01381094|141468567|SUPERIORITY||||||=|0.2026|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.2026
70980404|NCT01381094|141468567|SUPERIORITY||||||=|0.5703|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.5703
70980405|NCT01381094|141468568|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||<0.0001
70980406|NCT01381094|141468568|SUPERIORITY||||||=|0.0092|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0092
70980407|NCT01381094|141468568|SUPERIORITY||||||=|0.0012|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0012
70980408|NCT01381094|141468568|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||<0.0001
70980409|NCT01381094|141468568|SUPERIORITY||||||=|0.1157|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.1157
70980410|NCT01381094|141468568|SUPERIORITY||||||=|0.0069|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0069
70980411|NCT01381094|141468568|SUPERIORITY||||||=|0.0034|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0034
71035520|NCT03437265|141579877|OTHER||||||||||||||||||PK parameters were estimated for each subject by non-compartmental analysis methods using Phoenix® WinNonlin® software (v8.0, Certara USA, Inc., USA). Summary statistics (n, mean, SD, CV%, median, minimum, maximum, geometric n, geometric mean (geometric SD) and geometric CV%) were presented. The Geometric CV for glycolic acid was Not Calculated (appears as 0%).|||
70980412|NCT01381094|141468568|SUPERIORITY||||||=|0.0067|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0067
70980413|NCT01381094|141468568|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||<0.0001
70980414|NCT01381094|141468568|SUPERIORITY||||||=|0.0401|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0401
70980415|NCT01381094|141468568|SUPERIORITY||||||=|0.0042|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0042
70980416|NCT01381094|141468568|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
70980417|NCT01381094|141468568|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0002
70980418|NCT01381094|141468568|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
70980419|NCT01381094|141468568|SUPERIORITY||||||=|0.0422|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0422
71035521|NCT03437265|141579878|OTHER||||||||||||||||||Summary of the number of bowel movements per time period for the PD analysis set|||
71035522|NCT03437265|141579879|OTHER||||||||||||||||||The time (in minutes) to achieve clear effluent/time to turbid contents is presented for the PD analysis set.|||
70980420|NCT01381094|141468568|SUPERIORITY||||||=|0.0232|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0232
70980421|NCT01381094|141468568|SUPERIORITY||||||=|0.0243|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0243
71035523|NCT00840476|141579889|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.26||||||90.0|93.12|107.95|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107.95|93.12|
70980422|NCT01381094|141468568|SUPERIORITY||||||=|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0001
70980423|NCT01381094|141468568|SUPERIORITY||||||=|0.1089|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.1089
70980424|NCT01381094|141468568|SUPERIORITY||||||=|0.0833|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0833
70980425|NCT01381094|141468570|SUPERIORITY||||||=|0.5456|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||||||=0.5456
70980426|NCT01381094|141468570|SUPERIORITY||||||=|0.0053|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||||||=0.0053
70980427|NCT01381094|141468570|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||||||<0.0001
70980428|NCT01381094|141468570|SUPERIORITY||||||=|0.004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||||||=0.0040
71035524|NCT00840476|141579890|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|105.14||||||90.0|100.27|110.25|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||110.25|100.27|
71035525|NCT00840476|141579891|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|104.33||||||90.0|99.16|109.76|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109.76|99.16|
71035526|NCT03364192|141579899|OTHER|Multilevel modeling adapted for multiple-baseline design comparing participant goal attainment before, during, and after peer-delivered Whole Health Coaching.|||||<|0.05|||||||Multilevel Modeling|||||||<0.05
71096688|NCT02547935|141702442|SUPERIORITY||Difference in adjusted mean change|-0.58|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.8|-0.37||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures analysis included the fixed categorical effects of treatment, week, randomisation stratification factor (i.e. anti-diabetic treatment strata), and treatment-by-week interaction, as well as the continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.||-0.37|-0.80|<0.001
70980429|NCT01381094|141468570|SUPERIORITY||||||=|0.2017|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||||||=0.2017
70980430|NCT03895203|141468610|SUPERIORITY||Odds Ratio (OR)|7.082|||<|0.001|TWO_SIDED|95.0|4.583|10.943|||Regression, Logistic|||||10.943|4.583|<0.001
70980431|NCT03895203|141468611|SUPERIORITY||Least square (LS) mean difference|-0.187|||<|0.001|TWO_SIDED|95.0|-0.249|-0.125|||ANCOVA|||||-0.125|-0.249|<0.001
70980432|NCT03895203|141468613|SUPERIORITY||Odds Ratio (OR)|63.039|||<|0.001|TWO_SIDED|95.0|22.211|178.918|||Regression, Logistic|||||178.918|22.211|<0.001
70980433|NCT03895203|141468614|SUPERIORITY||LS mean difference|4.337|||<|0.001|TWO_SIDED|95.0|3.229|5.444|||ANCOVA|||||5.444|3.229|<0.001
70980434|NCT03895203|141468615|SUPERIORITY||Odds Ratio (OR)|5.447|||<|0.001|TWO_SIDED|95.0|3.668|8.088|||Regression, Logistic|||||8.088|3.668|<0.001
70980435|NCT03895203|141468616|SUPERIORITY||LS mean difference|-0.327||||0.001|TWO_SIDED|95.0|-0.524|-0.13|||ANOVA|||||-0.130|-0.524|0.001
70980436|NCT03895203|141468617|SUPERIORITY||Odds Ratio (OR)|1.904||||0.008|TWO_SIDED|95.0|1.18|3.074|||Regression, Logistic|||||3.074|1.180|0.008
70980437|NCT03895203|141468618|SUPERIORITY||Odds Ratio (OR)|3.437||||0.002|TWO_SIDED|95.0|1.559|7.574|||Regression, Logistic|||||7.574|1.559|0.002
70980438|NCT03895203|141468620|SUPERIORITY||LS mean difference|-0.281||||0.001|TWO_SIDED|95.0|-0.452|-0.111|||ANCOVA|||||-0.111|-0.452|0.001
70980439|NCT00996840|141468650|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.562|STANDARD_ERROR_OF_MEAN|0.228|||TWO_SIDED|95.0|0.357|0.885||||||Comparison at 6 h post first dose||0.885|0.357|
70980440|NCT00996840|141468650|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.612|STANDARD_ERROR_OF_MEAN|0.281|||TWO_SIDED|95.0|0.349|1.072||||||Comparison at 12 h post first dose||1.072|0.349|
70980441|NCT00996840|141468650|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.518|STANDARD_ERROR_OF_MEAN|0.319|||TWO_SIDED|95.0|0.274|0.981||||||Comparison at 18 h post first dose||0.981|0.274|
70980442|NCT00996840|141468650|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.416|STANDARD_ERROR_OF_MEAN|0.326|||TWO_SIDED|95.0|0.217|0.796||||||Comparison at 24 h post first dose||0.796|0.217|
70980443|NCT00996840|141468650|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.517|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|0.262|1.021||||||Comparison at 48 h post first dose||1.021|0.262|
70980444|NCT00996840|141468650|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.661|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|0.291|1.503||||||Comparison at 72 h post first dose||1.503|0.291|
70980445|NCT00996840|141468650|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.908|STANDARD_ERROR_OF_MEAN|0.454|||TWO_SIDED|95.0|0.366|2.254||||||Comparison at 96 h post first dose||2.254|0.366|
70980446|NCT00996840|141468650|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.768|STANDARD_ERROR_OF_MEAN|0.195|||TWO_SIDED|95.0|0.52|1.134||||||Comparison at 6 h post first dose||1.134|0.520|
70980447|NCT00996840|141468650|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.701|STANDARD_ERROR_OF_MEAN|0.248|||TWO_SIDED|95.0|0.427|1.15||||||Comparison at 12 h post first dose||1.150|0.427|
70980448|NCT00996840|141468650|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.578|STANDARD_ERROR_OF_MEAN|0.282|||TWO_SIDED|95.0|0.329|1.015||||||Comparison at 18 h post first dose||1.015|0.329|
70980449|NCT00996840|141468650|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.41|STANDARD_ERROR_OF_MEAN|0.287|||TWO_SIDED|95.0|0.231|0.728||||||Comparison at 24 h post first dose||0.728|0.231|
70980450|NCT00996840|141468650|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.896|STANDARD_ERROR_OF_MEAN|0.308|||TWO_SIDED|95.0|0.484|1.657||||||Comparison at 48 h post first dose||1.657|0.484|
70980451|NCT00996840|141468650|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.739|STANDARD_ERROR_OF_MEAN|0.374|||TWO_SIDED|95.0|0.35|1.563||||||Comparison at 72 h post first dose||1.563|0.350|
70980452|NCT00996840|141468650|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.56|STANDARD_ERROR_OF_MEAN|0.431|||TWO_SIDED|95.0|0.659|3.697||||||Comparison at 96 h post first dose||3.697|0.659|
70980453|NCT00996840|141468650|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.608|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|0.433|0.853||||||Comparison at 6 h post first dose||0.853|0.433|
70980454|NCT00996840|141468650|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.674|STANDARD_ERROR_OF_MEAN|0.217|||TWO_SIDED|95.0|0.437|1.039||||||Comparison at 12 h post first dose||1.039|0.437|
70980455|NCT00996840|141468650|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.613|STANDARD_ERROR_OF_MEAN|0.247|||TWO_SIDED|95.0|0.374|1.004||||||Comparison at 18 h post first dose||1.004|0.374|
70980456|NCT00996840|141468650|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.558|STANDARD_ERROR_OF_MEAN|0.251|||TWO_SIDED|95.0|0.338|0.921||||||Comparison at 24 h post first dose||0.921|0.338|
70980457|NCT00996840|141468650|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.725|STANDARD_ERROR_OF_MEAN|0.264|||TWO_SIDED|95.0|0.427|1.23||||||Comparison at 48 h post first dose||1.230|0.427|
70980458|NCT00996840|141468650|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.73|STANDARD_ERROR_OF_MEAN|0.321|||TWO_SIDED|95.0|0.384|1.386||||||Comparison at 72 h post first dose||1.386|0.384|
70980459|NCT00996840|141468650|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.147|STANDARD_ERROR_OF_MEAN|0.359|||TWO_SIDED|95.0|0.559|2.353||||||Comparison at 96 h post first dose||2.353|0.559|
70980460|NCT00996840|141468650|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.776|STANDARD_ERROR_OF_MEAN|0.167|||TWO_SIDED|95.0|0.556|1.082||||||Comparison at 6 h post first dose||1.082|0.556|
70980461|NCT00996840|141468650|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.602|STANDARD_ERROR_OF_MEAN|0.212|||TWO_SIDED|95.0|0.394|0.919||||||Comparison at 12 h post first dose||0.919|0.394|
70980462|NCT00996840|141468650|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.623|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|0.386|1.007||||||Comparison at 18 h post first dose||1.007|0.386|
71096689|NCT02547935|141702443|SUPERIORITY||Difference in adjusted mean change|-38.0|STANDARD_ERROR_OF_MEAN|5.7|<|0.001|TWO_SIDED|95.0|-48.2|-25.8||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation stratification factor (i.e. anti-diabetic treatment strata), as well as the continuous fixed covariates of log-baseline UACR value and log-baseline UACR value-by-week interaction.||-25.8|-48.2|<0.001
71096690|NCT02547935|141702443|SUPERIORITY||Difference in adjusted mean change|-21.0|STANDARD_ERROR_OF_MEAN|7.3||0.011|TWO_SIDED|95.0|-34.1|-5.2||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation stratification factor (i.e. anti-diabetic treatment strata), as well as the continuous fixed covariates of log-baseline UACR value and log-baseline UACR value-by-week interaction.||-5.2|-34.1|0.011
70980463|NCT00996840|141468650|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.429|STANDARD_ERROR_OF_MEAN|0.245|||TWO_SIDED|95.0|0.263|0.7||||||Comparison at 24 h post first dose||0.700|0.263|
70980464|NCT00996840|141468650|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.502|STANDARD_ERROR_OF_MEAN|0.259|||TWO_SIDED|95.0|0.299|0.842||||||Comparison at 48 h post first dose||0.842|0.299|
70980465|NCT00996840|141468650|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.479|STANDARD_ERROR_OF_MEAN|0.317|||TWO_SIDED|95.0|0.255|0.903||||||Comparison at 72 h post first dose||0.903|0.255|
70980466|NCT00996840|141468650|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.579|STANDARD_ERROR_OF_MEAN|0.361|||TWO_SIDED|95.0|0.281|1.192||||||Comparison at 96 h post first dose||1.192|0.281|
70980467|NCT00996840|141468651|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.484|STANDARD_ERROR_OF_MEAN|0.219|||TWO_SIDED|95.0|0.312|0.75||||||Comparison at 6 h post first dose||0.750|0.312|
70980468|NCT00996840|141468651|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.7|STANDARD_ERROR_OF_MEAN|0.282|||TWO_SIDED|95.0|0.399|1.229||||||Comparison at 12 h post first dose||1.229|0.399|
70980469|NCT00996840|141468651|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.681|STANDARD_ERROR_OF_MEAN|0.305|||TWO_SIDED|95.0|0.37|1.254||||||Comparison at 18 h post first dose||1.254|0.370|
71035527|NCT05133180|141579909|SUPERIORITY|The following null hypothesis is defined on this endpoint: the number of patients reaching a value of Schirmer I test (without anaesthesia) \>10mm/5min at week 4 in cenegermin (rhNGF) is lower or equal than control. The null hypothesis is rejected if the associated primary analysis p-value is lower than 0.025.|Odds Ratio (OR)|16.946|||<|0.001|TWO_SIDED|95.0|3.412|84.165||P-value of treatment variable from logistic regression model on the number of patients reaching a value of Schirmer I test (without anaesthesia) \>10mm/5min|Regression, Logistic|||It was analyzed by means of a logistic regression model adjusting by pre-defined baseline factors (treatment, gender, age class, baseline Schirmer I test value as fixed effects and site as random effect). For the imputation of missing data at week 4, a Multiple Imputation approach is adopted by performing a regression model with the baseline Schirmer I test value, gender, age class, and Schirmer I test at week 2 as explanatory variables and generating 200 datasets.||84.165|3.412|<0.001
71035528|NCT05133180|141579910|SUPERIORITY|The following null hypothesis is defined on this endpoint: the change from baseline (reduction) in the global SANDE score at week 12 in cenegermin is lower or equal than control. The null hypothesis is rejected if the associated primary analysis p-value is lower than 0.025.|adjusted mean difference|-4.561||||0.322|TWO_SIDED|95.0|-13.581|4.459||P-value of adjusted means difference between treatments from the ANCOVA model on change from baseline in the global SANDE score.|ANCOVA|||This endpoint was analyzed by means of an Analysis of Covariance with change from baseline in global SANDE Score at Week 12 as dependent variable, treatment, gender, age class, baseline global SANDE score as fixed effects and site as random effect. For missing data, Multiple Imputation approach is adopted by performing a regression model with the baseline global SANDE score, gender, age class, and intermediate global SANDE scores up to week 12 as explanatory variables and generating 200 datasets||4.459|-13.581|0.322
70980470|NCT00996840|141468651|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.673|STANDARD_ERROR_OF_MEAN|0.302|||TWO_SIDED|95.0|0.368|1.231||||||Comparison at 24 h post first dose||1.231|0.368|
70980471|NCT00996840|141468651|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.92|STANDARD_ERROR_OF_MEAN|0.351|||TWO_SIDED|95.0|0.456|1.857||||||Comparison at 48 h post first dose||1.857|0.456|
70980472|NCT00996840|141468651|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.944|STANDARD_ERROR_OF_MEAN|0.376|||TWO_SIDED|95.0|0.445|2.002||||||Comparison at 72 h post first dose||2.002|0.445|
70980473|NCT00996840|141468651|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.905|STANDARD_ERROR_OF_MEAN|0.321|||TWO_SIDED|95.0|0.476|1.723||||||Comparison at 96 h post first dose||1.723|0.476|
70980474|NCT00996840|141468651|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.726|STANDARD_ERROR_OF_MEAN|0.199|||TWO_SIDED|95.0|0.488|1.08||||||Comparison at 6 h post first dose||1.080|0.488|
70980475|NCT00996840|141468651|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.791|STANDARD_ERROR_OF_MEAN|0.255|||TWO_SIDED|95.0|0.476|1.317||||||Comparison at 12 h post first dose||1.317|0.476|
70980476|NCT00996840|141468651|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.725|STANDARD_ERROR_OF_MEAN|0.277|||TWO_SIDED|95.0|0.417|1.26||||||Comparison at 18 h post first dose||1.260|0.417|
70980477|NCT00996840|141468651|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.655|STANDARD_ERROR_OF_MEAN|0.273|||TWO_SIDED|95.0|0.379|1.13||||||Comparison at 24 h post first dose||1.130|0.379|
70980478|NCT00996840|141468651|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.111|STANDARD_ERROR_OF_MEAN|0.323|||TWO_SIDED|95.0|0.583|2.12||||||Comparison at 48 h post first dose||2.120|0.583|
70980479|NCT00996840|141468651|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.075|STANDARD_ERROR_OF_MEAN|0.346|||TWO_SIDED|95.0|0.539|2.146||||||Comparison at 72 h post first dose||2.146|0.539|
70980480|NCT00996840|141468651|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.375|STANDARD_ERROR_OF_MEAN|0.313|||TWO_SIDED|95.0|0.735|2.574||||||Comparison at 96 h post first dose||2.574|0.735|
70980481|NCT00996840|141468651|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.559|STANDARD_ERROR_OF_MEAN|0.168|||TWO_SIDED|95.0|0.4|0.783||||||Comparison at 6 h post first dose||0.783|0.400|
70980482|NCT00996840|141468651|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.83|STANDARD_ERROR_OF_MEAN|0.216|||TWO_SIDED|95.0|0.539|1.277||||||Comparison at 12 h post first dose||1.277|0.539|
70980483|NCT00996840|141468651|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.987|STANDARD_ERROR_OF_MEAN|0.238|||TWO_SIDED|95.0|0.613|1.589||||||Comparison at 18 h post first dose||1.589|0.613|
71096691|NCT02547935|141702444|SUPERIORITY||Difference in adjusted mean change|-0.04|STANDARD_ERROR_OF_MEAN|0.66||0.953|TWO_SIDED|95.0|-1.32|1.26||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation stratification factor (i.e. anti-diabetic treatment strata), as well as the continuous fixed covariates of log-baseline total body weight value and log-baseline total body weight value-by-week interaction.||1.26|-1.32|0.953
70980484|NCT00996840|141468651|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.924|STANDARD_ERROR_OF_MEAN|0.231|||TWO_SIDED|95.0|0.582|1.467||||||Comparison at 24 h post first dose||1.467|0.582|
70980485|NCT00996840|141468651|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.23|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|0.716|2.11||||||Comparison at 48 h post first dose||2.110|0.716|
70980486|NCT00996840|141468651|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.289|STANDARD_ERROR_OF_MEAN|0.292|||TWO_SIDED|95.0|0.719|2.312||||||Comparison at 72 h post first dose||2.312|0.719|
70980487|NCT00996840|141468651|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.752|STANDARD_ERROR_OF_MEAN|0.254|||TWO_SIDED|95.0|1.053|2.916||||||Comparison at 96 h post first dose||2.916|1.053|
70980488|NCT00996840|141468651|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.58|STANDARD_ERROR_OF_MEAN|0.163|||TWO_SIDED|95.0|0.419|0.803||||||Comparison at 6 h post first dose||0.803|0.419|
70980489|NCT00996840|141468651|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.657|STANDARD_ERROR_OF_MEAN|0.209|||TWO_SIDED|95.0|0.433|0.996||||||Comparison at 12 h post first dose||0.996|0.433|
70980490|NCT00996840|141468651|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.747|STANDARD_ERROR_OF_MEAN|0.225|||TWO_SIDED|95.0|0.477|1.171||||||Comparison at 18 h post first dose||1.171|0.477|
70980491|NCT00996840|141468651|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.657|STANDARD_ERROR_OF_MEAN|0.222|||TWO_SIDED|95.0|0.421|1.024||||||Comparison at 24 h post first dose||1.024|0.421|
70980492|NCT00996840|141468651|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.759|STANDARD_ERROR_OF_MEAN|0.261|||TWO_SIDED|95.0|0.451|1.279||||||Comparison at 48 h post first dose||1.279|0.451|
70980493|NCT00996840|141468651|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.968|STANDARD_ERROR_OF_MEAN|0.282|||TWO_SIDED|95.0|0.55|1.701||||||Comparison at 72 h post first dose||1.701|0.550|
70980494|NCT00996840|141468651|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.744|STANDARD_ERROR_OF_MEAN|0.251|||TWO_SIDED|95.0|0.45|1.229||||||Comparison at 96 h post first dose||1.229|0.450|
70980495|NCT00996840|141468652|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.773|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|0.607|0.985||||||Comparison at 6 h post first dose||0.985|0.607|
70980496|NCT00996840|141468652|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.795|STANDARD_ERROR_OF_MEAN|0.155|||TWO_SIDED|95.0|0.583|1.084||||||Comparison at 12 h post first dose||1.084|0.583|
70980497|NCT00996840|141468652|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.778|STANDARD_ERROR_OF_MEAN|0.189|||TWO_SIDED|95.0|0.533|1.135||||||Comparison at 18 h post first dose||1.135|0.533|
70980498|NCT00996840|141468652|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.633|STANDARD_ERROR_OF_MEAN|0.193|||TWO_SIDED|95.0|0.43|0.931||||||Comparison at 24 h post first dose||0.931|0.430|
70980499|NCT00996840|141468652|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.662|STANDARD_ERROR_OF_MEAN|0.255|||TWO_SIDED|95.0|0.397|1.103||||||Comparison at 48 h post first dose||1.103|0.397|
70980500|NCT00996840|141468652|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.465|STANDARD_ERROR_OF_MEAN|0.243|||TWO_SIDED|95.0|0.286|0.756||||||Comparison at 72 h post first dose||0.756|0.286|
70980501|NCT00996840|141468652|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.525|STANDARD_ERROR_OF_MEAN|0.287|||TWO_SIDED|95.0|0.295|0.935||||||Comparison at 96 h post first dose||0.935|0.295|
70980502|NCT00996840|141468652|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.952|STANDARD_ERROR_OF_MEAN|0.107|||TWO_SIDED|95.0|0.768|1.18||||||Comparison at 6 h post first dose||1.180|0.768|
70980503|NCT00996840|141468652|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.965|STANDARD_ERROR_OF_MEAN|0.137|||TWO_SIDED|95.0|0.733|1.269||||||Comparison at 12 h post first dose||1.269|0.733|
70980504|NCT00996840|141468652|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.992|STANDARD_ERROR_OF_MEAN|0.168|||TWO_SIDED|95.0|0.71|1.387||||||Comparison at 18 h post first dose||1.387|0.710|
70980505|NCT00996840|141468652|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.913|STANDARD_ERROR_OF_MEAN|0.171|||TWO_SIDED|95.0|0.649|1.285||||||Comparison at 24 h post first dose||1.285|0.649|
70980506|NCT00996840|141468652|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.66|STANDARD_ERROR_OF_MEAN|0.233|||TWO_SIDED|95.0|0.415|1.051||||||Comparison at 48 h post first dose||1.051|0.415|
70980507|NCT00996840|141468652|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.69|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|0.445|1.072||||||Comparison at 72 h post first dose||1.072|0.445|
70980508|NCT00996840|141468652|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.724|STANDARD_ERROR_OF_MEAN|0.268|||TWO_SIDED|95.0|0.423|1.239||||||Comparison at 96 h post first dose||1.239|0.423|
70980509|NCT00996840|141468652|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.95|STANDARD_ERROR_OF_MEAN|0.093|||TWO_SIDED|95.0|0.789|1.144||||||Comparison at 6 h post first dose||1.144|0.789|
70980510|NCT00996840|141468652|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.985|STANDARD_ERROR_OF_MEAN|0.119|||TWO_SIDED|95.0|0.777|1.249||||||Comparison at 12 h post first dose||1.249|0.777|
70980511|NCT00996840|141468652|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.067|STANDARD_ERROR_OF_MEAN|0.146|||TWO_SIDED|95.0|0.797|1.428||||||Comparison at 18 h post first dose||1.428|0.797|
70980512|NCT00996840|141468652|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.922|STANDARD_ERROR_OF_MEAN|0.148|||TWO_SIDED|95.0|0.686|1.239||||||Comparison at 24 h post first dose||1.239|0.686|
70980513|NCT00996840|141468652|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.866|STANDARD_ERROR_OF_MEAN|0.198|||TWO_SIDED|95.0|0.583|1.287||||||Comparison at 48 h post first dose||1.287|0.583|
70980514|NCT00996840|141468652|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.649|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|0.444|0.95||||||Comparison at 72 h post first dose||0.950|0.444|
70980515|NCT00996840|141468652|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.722|STANDARD_ERROR_OF_MEAN|0.228|||TWO_SIDED|95.0|0.457|1.14||||||Comparison at 96 h post first dose||1.140|0.457|
70980516|NCT00996840|141468652|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.897|STANDARD_ERROR_OF_MEAN|0.091|||TWO_SIDED|95.0|0.748|1.075||||||Comparison at 6 h post first dose||1.075|0.748|
70980517|NCT00996840|141468652|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.887|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|0.703|1.119||||||Comparison at 12 h post first dose||1.119|0.703|
70980518|NCT00996840|141468652|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.846|STANDARD_ERROR_OF_MEAN|0.142|||TWO_SIDED|95.0|0.638|1.123||||||Comparison at 18 h post first dose||1.123|0.638|
71035529|NCT05133180|141579911|SUPERIORITY|Analysis was based on a logistic regression with the number of patients reaching a value of Schirmer I test \>10mm/5min at week 8 as dependent variable, treatment, gender, age class and baseline Schirmer I test value as qualitative independent variables. Site was considered as random effects that vary randomly among patients.|Odds Ratio (OR)|15.95|||<|0.001|TWO_SIDED|95.0|3.091|82.31|||Regression, Logistic|||This key secondary endpoint was analyzed by means of a logistic regression model with the number of patients reaching a value of Schirmer I test \>10mm/5min at Week 8 as dependent variable, treatment, gender, age class and baseline Schirmer I test value as fixed effects and site as random effect.||82.310|3.091|<0.001
71035530|NCT05133180|141579912|SUPERIORITY||adjusted mean difference|-2.753||||0.572|TWO_SIDED|95.0|-12.303|6.798||P-value of adjusted means difference between treatments from the ANCOVA model on change from baseline in SANDE score for frequency at Week 12.|ANCOVA regression model|||This endpoint was analyzed by means of an ANCOVA adjusting by pre-defined baseline factors (treatment, gender, age class, baseline SANDE score for severity as fixed effects and site as random effect).||6.798|-12.303|0.572
70980519|NCT00996840|141468652|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.812|STANDARD_ERROR_OF_MEAN|0.145|||TWO_SIDED|95.0|0.609|1.084||||||Comparison at 24 h post first dose||1.084|0.609|
70980520|NCT00996840|141468652|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.58|STANDARD_ERROR_OF_MEAN|0.194|||TWO_SIDED|95.0|0.394|0.855||||||Comparison at 48 h post first dose||0.855|0.394|
70980521|NCT00996840|141468652|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.439|STANDARD_ERROR_OF_MEAN|0.188|||TWO_SIDED|95.0|0.301|0.639||||||Comparison at 72 h post first dose||0.639|0.301|
70980522|NCT00996840|141468652|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.451|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|0.285|0.714||||||Comparison at 96 h post first dose||0.714|0.285|
70980523|NCT00996840|141468653|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.85|STANDARD_ERROR_OF_MEAN|0.137|||TWO_SIDED|95.0|0.646|1.119||||||Comparison at 6 h post first dose||1.119|0.646|
70980524|NCT00996840|141468653|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.072|STANDARD_ERROR_OF_MEAN|0.138|||TWO_SIDED|95.0|0.814|1.411||||||Comparison at 12 h post first dose||1.411|0.814|
70980525|NCT00996840|141468653|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.08|STANDARD_ERROR_OF_MEAN|0.157|||TWO_SIDED|95.0|0.79|1.478||||||Comparison at 18 h post first dose||1.478|0.790|
70980526|NCT00996840|141468653|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.951|STANDARD_ERROR_OF_MEAN|0.143|||TWO_SIDED|95.0|0.715|1.266||||||Comparison at 24 h post first dose||1.266|0.715|
70980527|NCT00996840|141468653|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.918|STANDARD_ERROR_OF_MEAN|0.168|||TWO_SIDED|95.0|0.655|1.285||||||Comparison at 48 h post first dose||1.285|0.655|
70980528|NCT00996840|141468653|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.012|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|0.735|1.395||||||Comparison at 72 h post first dose||1.395|0.735|
70980529|NCT00996840|141468653|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.168|STANDARD_ERROR_OF_MEAN|0.169|||TWO_SIDED|95.0|0.831|1.64||||||Comparison at 96 h post first dose||1.640|0.831|
70980530|NCT00996840|141468653|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.912|STANDARD_ERROR_OF_MEAN|0.124|||TWO_SIDED|95.0|0.713|1.167||||||Comparison at 6 h post first dose||1.167|0.713|
70980531|NCT00996840|141468653|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.963|STANDARD_ERROR_OF_MEAN|0.123|||TWO_SIDED|95.0|0.753|1.233||||||Comparison at 12 h post first dose||1.233|0.753|
70980532|NCT00996840|141468653|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.917|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.693|1.214||||||Comparison at 18 h post first dose||1.214|0.693|
70980533|NCT00996840|141468653|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.87|STANDARD_ERROR_OF_MEAN|0.128|||TWO_SIDED|95.0|0.673|1.123||||||Comparison at 24 h post first dose||1.123|0.673|
70980534|NCT00996840|141468653|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.141|STANDARD_ERROR_OF_MEAN|0.153|||TWO_SIDED|95.0|0.84|1.55||||||Comparison at 48 h post first dose||1.550|0.840|
70980535|NCT00996840|141468653|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.122|STANDARD_ERROR_OF_MEAN|0.146|||TWO_SIDED|95.0|0.837|1.505||||||Comparison at 72 h post first dose||1.505|0.837|
70980536|NCT00996840|141468653|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.474|STANDARD_ERROR_OF_MEAN|0.164|||TWO_SIDED|95.0|1.063|2.045||||||Comparison at 96 h post first dose||2.045|1.063|
70980537|NCT00996840|141468653|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.833|STANDARD_ERROR_OF_MEAN|0.107|||TWO_SIDED|95.0|0.672|1.031||||||Comparison at 6 h post first dose||1.031|0.672|
70980538|NCT00996840|141468653|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.879|STANDARD_ERROR_OF_MEAN|0.109|||TWO_SIDED|95.0|0.707|1.092||||||Comparison at 12 h post first dose||1.092|0.707|
70980539|NCT00996840|141468653|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.023|STANDARD_ERROR_OF_MEAN|0.123|||TWO_SIDED|95.0|0.8|1.307||||||Comparison at 18 h post first dose||1.307|0.800|
70980540|NCT00996840|141468653|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.95|STANDARD_ERROR_OF_MEAN|0.111|||TWO_SIDED|95.0|0.761|1.187||||||Comparison at 24 h post first dose||1.187|0.761|
70980541|NCT00996840|141468653|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.968|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|0.743|1.262||||||Comparison at 48 h post first dose||1.262|0.743|
70980542|NCT00996840|141468653|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.926|STANDARD_ERROR_OF_MEAN|0.127|||TWO_SIDED|95.0|0.718|1.193||||||Comparison at 72 h post first dose||1.193|0.718|
70980543|NCT00996840|141468653|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.229|STANDARD_ERROR_OF_MEAN|0.136|||TWO_SIDED|95.0|0.936|1.613||||||Comparison at 96 h post first dose||1.613|0.936|
70980544|NCT00996840|141468653|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.923|STANDARD_ERROR_OF_MEAN|0.102|||TWO_SIDED|95.0|0.753|1.131||||||Comparison at 6 h post first dose||1.131|0.753|
70980545|NCT00996840|141468653|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.768|STANDARD_ERROR_OF_MEAN|0.103|||TWO_SIDED|95.0|0.625|0.943||||||Comparison at 12 h post first dose||0.943|0.625|
70980546|NCT00996840|141468653|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.826|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|0.655|1.042||||||Comparison at 18 h post first dose||1.042|0.655|
70980547|NCT00996840|141468653|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.761|STANDARD_ERROR_OF_MEAN|0.106|||TWO_SIDED|95.0|0.615|0.942||||||Comparison at 24 h post first dose||0.942|0.615|
70980548|NCT00996840|141468653|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.781|STANDARD_ERROR_OF_MEAN|0.125|||TWO_SIDED|95.0|0.608|1.003||||||Comparison at 48 h post first dose||1.003|0.608|
71096692|NCT02547935|141702444|SUPERIORITY||Difference in adjusted mean change|-0.87|STANDARD_ERROR_OF_MEAN|0.66||0.193|TWO_SIDED|95.0|-2.17|0.44||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation stratification factor (i.e. anti-diabetic treatment strata), as well as the continuous fixed covariates of log-baseline total body weight value and log-baseline total body weight value-by-week interaction.||0.44|-2.17|0.193
71096693|NCT02547935|141702445|SUPERIORITY||Difference in adjusted mean change|-6.1|STANDARD_ERROR_OF_MEAN|5.8||0.298|TWO_SIDED|95.0|-17.5|5.4||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures analysis included the fixed categorical effects of treatment, week, randomisation stratification factor (i.e.anti-diabetic treatment strata), and treatment-by-week interaction, as well as the continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.||5.4|-17.5|0.298
71096694|NCT02547935|141702445|SUPERIORITY||Difference in adjusted mean change|-1.9|STANDARD_ERROR_OF_MEAN|5.9||0.746|TWO_SIDED|95.0|-13.6|9.8||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures analysis included the fixed categorical effects of treatment, week, randomisation stratification factor (i.e.anti-diabetic treatment strata), and treatment-by-week interaction, as well as the continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.||9.8|-13.6|0.746
70980549|NCT00996840|141468653|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.668|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|0.524|0.851||||||Comparison at 72 h post first dose||0.851|0.524|
70980550|NCT00996840|141468653|OTHER||Ratio (Treatment/Placebo)|0.86|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|95.0|0.659|1.122||||||Comparison at 96 h post first dose||1.122|0.659|
70980551|NCT01485614|141468667|SUPERIORITY||Least Squares Means Difference|-0.19|||=|0.448|TWO_SIDED|95.0|-0.68|0.3|||Mixed Models Analysis|"The Least Squares (LS) Mean for the arm Sitagliptin is compared against that of Placebo (pooled)."||||0.30|-0.68|= 0.448
70980552|NCT01485614|141468669|OTHER||Difference in Percentage|2.4|||||TWO_SIDED|95.0|-10.0|14.9||"Percentage of participants with ≥1 adverse event for the arm Sitagliptin was compared against that of Placebo/Metformin with Miettinen \& Nurminen."||||||14.9|-10.0|
70980553|NCT01485614|141468671|OTHER||Difference in percentage|4.2|||||TWO_SIDED|95.0|-1.3|10.8||"Percentage of participants with ≥1 adverse event for the arm Sitagliptin was compared against that of Placebo/Metformin with Miettinen \& Nurminen."||||||10.8|-1.3|
70980554|NCT01485614|141468674|SUPERIORITY||Difference in percentage|6.7|||=|0.374|TWO_SIDED|95.0|-8.1|21.2||"Percentage of participants with an A1C goal (7.0%) in the arm Sitagliptin was compared against the arm Placebo (pooled)."|Miettinen and Nurminen||||For estimating the treatment difference, when the A1C result for a participant at Week 20 was not available, a multiple imputation method based on the Linear Discriminant Analysis (LDA) model was used to impute whether the participant had met the goal.|21.2|-8.1|= 0.374
70980555|NCT01485614|141468676|SUPERIORITY||Difference in percentage|3.6|||=|0.639|TWO_SIDED|95.0|-11.6|18.3|||Miettinen and Nurminen|"The percentage of participants with an A1C at the A1C goal (6.5%) in the arm Sitagliptin was compared against the arm Placebo (pooled)."|||For estimating the treatment difference, when the A1C result for a participant at Week 20 was not available, a multiple imputation method based on the LDA model was used to impute whether the participant had met the goal.|18.3|-11.6|= 0.639
70980556|NCT01485614|141468681|SUPERIORITY||Least Squares Means Difference|1.5|||=|0.849|TWO_SIDED|95.0|-14.4|17.5|||Mixed Models Analysis|"The Least Squares (LS) Mean for the arm Sitagliptin was compared against that of Placebo (pooled)."||||17.5|-14.4|= 0.849
70980557|NCT02210780|141468760|SUPERIORITY||Percentage Difference|34.0|||<|0.0001|TWO_SIDED|90.0|24.29|43.75|||Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using Cochran-Mantel-Haenszel test stratified by randomization strata (moderate \[IGA=3\] vs. severe \[IGA=4\] AD).||43.75|24.29|<0.0001
71096695|NCT02547935|141702446|SUPERIORITY||Odds Ratio (OR)|2.98|||<|0.001|TWO_SIDED|95.0|1.8|4.8||Statistical significance level = 0.025.|Regression, Logistic|||Logistic regression model analysis with adjustment for baseline UACR and pooled randomisation strata.||4.8|1.8|<0.001
70980558|NCT02210780|141468761|SUPERIORITY||Percentage Difference|40.2|||<|0.0001|TWO_SIDED|90.0|29.4|51.01|||Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using Cochran-Mantel-Haenszel test stratified by randomization strata (moderate \[IGA=3\] vs. severe \[IGA=4\] AD).||51.01|29.40|<0.0001
70980559|NCT02210780|141468762|SUPERIORITY||Percentage Difference|34.0|||<|0.0001|TWO_SIDED|90.0|23.38|44.66|||Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using Cochran-Mantel-Haenszel test stratified by randomization strata (moderate \[IGA=3\] vs. severe \[IGA=4\] AD).||44.66|23.38|<0.0001
71096696|NCT02547935|141702446|SUPERIORITY||Odds Ratio (OR)|1.86||||0.013|TWO_SIDED|95.0|1.1|3.0||Statistical significance level = 0.025.|Regression, Logistic|||Logistic regression model analysis with adjustment for baseline UACR and pooled randomisation strata.||3.0|1.1|0.013
70980560|NCT02210780|141468763|SUPERIORITY||LS Mean Difference|-2.13|STANDARD_ERROR_OF_MEAN|0.354|<|0.0001|TWO_SIDED|90.0|-2.72|-1.55|||ANCOVA||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using ANCOVA model which includes treatment, randomization strata, and baseline value as covariates.||-1.55|-2.72|<0.0001
70980561|NCT02210780|141468764|SUPERIORITY||LS Mean Difference|-17.8|STANDARD_ERROR_OF_MEAN|2.84|<|0.0001|TWO_SIDED|90.0|-22.5|-13.1|||ANCOVA||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using ANCOVA model that includes treatment, randomization strata and baseline value as covariates.||-13.1|-22.5|<0.0001
71096697|NCT02547935|141702447|SUPERIORITY||Odds Ratio (OR)|5.43|||<|0.001|TWO_SIDED|95.0|2.6|11.2||Statistical significance level = 0.025.|Regression, Logistic|||Logistic regression model analysis with adjustment for baseline HbA1c and pooled randomisation strata.||11.2|2.6|<0.001
71096698|NCT02547935|141702447|SUPERIORITY||Odds Ratio (OR)|1.74||||0.167|TWO_SIDED|95.0|0.8|3.8||Statistical significance level = 0.025.|Regression, Logistic|||Logistic regression model analysis with adjustment for baseline HbA1c and pooled randomisation strata.||3.8|0.8|0.167
71096699|NCT02547935|141702448|SUPERIORITY||Difference in adjusted mean change|-4.8|STANDARD_ERROR_OF_MEAN|1.8||0.009|TWO_SIDED|95.0|-8.3|-1.2||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios, included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation strata, as well as the continuous fixed covariates of log-baseline SBP value and log-baseline SBP value-by-week interaction.||-1.2|-8.3|0.009
71096700|NCT02547935|141702448|SUPERIORITY||Difference in adjusted mean change|-2.8|STANDARD_ERROR_OF_MEAN|1.8||0.122|TWO_SIDED|95.0|-6.4|0.8||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios, included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation strata, as well as the continuous fixed covariates of log-baseline SBP value and log-baseline SBP value-by-week interaction.||0.8|-6.4|0.122
71096701|NCT02547935|141702449|SUPERIORITY||Difference in adjusted mean change|-0.16|STANDARD_ERROR_OF_MEAN|0.11||0.142|TWO_SIDED|95.0|-0.38|0.05||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures analysis included the fixed categorical effects of treatment, week, randomisation stratification factor (i.e. anti-diabetic treatment strata), and treatment-by-week interaction, as well as the continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.||0.05|-0.38|0.142
70980562|NCT02210780|141468766|SUPERIORITY||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|90.0|-3.0|-1.7|||ANCOVA||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using the ANCOVA model which includes treatment, randomization strata, and baseline values as covariates.||-1.7|-3.0|<0.0001
71096702|NCT03461861|141702450|SUPERIORITY||Median Difference (Final Values)|-0.083|STANDARD_DEVIATION|0.0056||0.007567|TWO_SIDED|95.0|-0.0886|-0.0774|||t-test, 2 sided|||The null hypothesis (H0) of this superiority trials asserts that there is no true difference in functional connectivity between the interventions of placebo and AGB101, and the alternative hypothesis (H1) states that there is a difference between the interventions of placebo and AGB101. A type I error is the error of rejecting H0 when it is actually true.||-0.0774|-0.0886|0.007567
71096703|NCT03461861|141702451|SUPERIORITY||Mean Difference (Final Values)|3.12|STANDARD_DEVIATION|1.4||0.900593|TWO_SIDED|95.0|1.72|4.52|||t-test, 2 sided|||The null hypothesis (H0) of this trial asserts that there is no true difference in AVLT between the interventions of placebo and AGB101, and the alternative hypothesis (H1) states that there is a difference between the interventions of placebo and AGB101. A type I error is the error of rejecting H0 when it is actually true.||4.52|1.72|0.900593
71096704|NCT01501513|141702473|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71096705|NCT01245751|141702518|NON_INFERIORITY_OR_EQUIVALENCE|Week 6 GMT value for Group 1 is statistically non-inferior to Group 2 for the prespecified clinically relevant 1.5-fold ratio if the lower bound of the 95% confidence interval for the GMT ratio is \>0.67|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.97|1.15||The alpha threshold for statistical significance is 0.025 (1-sided)|Longitudinal regression model|The analyzed GMT ratio, 95% confidence interval, and P-value were based on a longitudinal regression model adjusting for age and vaccination group||Week 6 analysis||1.15|0.97|<0.001
71096706|NCT01245751|141702519|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.54|||<|0.001|TWO_SIDED|95.0|1.44|1.66||The alpha threshold for statistical significance is 0.025 (1-sided)|Longitudinal regression model|The analyzed GMFR, 95% confidence interval, and P-value were based on a longitudinal regression model adjusting for age||A booster dose induces a statistically acceptable VZV antibody response if the lower bound of the 95% confidence interval is \>1.0.||1.66|1.44|<0.001
71096707|NCT05788328|141702521|OTHER||Ratio of Adjusted Geometric Means|86.5|||||TWO_SIDED|90.0|66.05|113.29|||||Ratio was of test to reference of adjusted geometric means. Reference arm was DE 150mg (Period 1) and test arm was PF-07081532 80mg QD + DE 150mg (Period 4). Ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||113.29|66.05|
71096708|NCT05788328|141702521|OTHER||Ratio of Adjusted Geometric Means|82.64|||||TWO_SIDED|90.0|63.1|108.24|||||Ratio was of test to reference of adjusted geometric means. Reference arm was DE 150mg (Period 1) and test arm was PF-07081532 240mg QD + DE 150mg (Period 7). Ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||108.24|63.10|
70980563|NCT02210780|141468767|SUPERIORITY||LS Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|0.99|<|0.0001|TWO_SIDED|90.0|-9.9|-6.6|||ANCOVA||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using the ANCOVA model which included treatment, randomization strata, and baseline value as covariates.||-6.6|-9.9|<0.0001
71008773|NCT02055976|141525253|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-59.2|STANDARD_ERROR_OF_MEAN|3.554|<|0.001|TWO_SIDED|95.0|-66.257|-52.143|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-52.143|-66.257|<0.001
71008774|NCT02055976|141525253|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-66.868|STANDARD_ERROR_OF_MEAN|3.595|<|0.001|TWO_SIDED|95.0|-74.007|-59.73|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-59.730|-74.007|<0.001
71008775|NCT02055976|141525253|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.051|STANDARD_ERROR_OF_MEAN|3.595|<|0.001|TWO_SIDED|95.0|-47.195|-32.908|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-32.908|-47.195|<0.001
71008776|NCT02055976|141525253|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.009|STANDARD_ERROR_OF_MEAN|3.587|<|0.001|TWO_SIDED|95.0|-63.135|-48.882|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-48.882|-63.135|<0.001
70980564|NCT00775021|141468769|NON_INFERIORITY_OR_EQUIVALENCE|Margin = -0.5|Mean Difference (Final Values)|0.2334|STANDARD_ERROR_OF_MEAN|0.1618|||TWO_SIDED|95.0|-0.03501|0.2334|||Mixed Models Analysis||The mean difference is calculated as etafilconA minus nelfilcon A. Analysis is adjusted for lens type, period, lens type by period interaction, gender, lens type by gender interaction as fixed effects, subject nested within site as random effect.|The alternative hypothesis is that etafilcon A contact lenses will have equal to ro higher ratings of overall comfort than nelfilcon A contact lenses.||0.2334|-0.03501|
70980565|NCT00775021|141468770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.108|STANDARD_ERROR_OF_MEAN|0.07768|||TWO_SIDED|98.7|-0.108|0.06501|||Mixed Models Analysis||Mean difference calculated etafilcon A minus nelfilcon A. Analysis adjusted for lens type, period, lens by period interaction, gender, lens by gender interaction as fixed effects, subject nested within site and eye within subject as random effect.|The alternative hypothesis is that eyes that wore etafilcon A contact lenses will have less inferior region corneal staining than eyes that wore nelfilcon A contact lenses.||0.06501|-0.1080|
70980566|NCT00775021|141468771|NON_INFERIORITY_OR_EQUIVALENCE|Margin = -0.5|Mean Difference (Final Values)|0.4001|STANDARD_ERROR_OF_MEAN|0.1799|||TWO_SIDED|98.7|-0.0055|0.4001|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus nelfilcon A.|The alternative hypothesis is that etafilcon A contact lenses have equal to or higher comfort ratings at the end of the day than nelfilcon A.||0.4001|-0.0055|
70980567|NCT00775021|141468772|NON_INFERIORITY_OR_EQUIVALENCE|Margin = -0.5|Mean Difference (Final Values)|-0.1088|STANDARD_ERROR_OF_MEAN|0.1741|||TWO_SIDED|98.7|-0.5016|-0.1088|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus nelfilcon A.|The alternative hypothesis is that etafilcon A contact lenses will have equal or higher ratings of initial comfort than nelfilcon A contact lenses.||-0.1088|-0.5016|
70980568|NCT00775021|141468773|NON_INFERIORITY_OR_EQUIVALENCE|Margin = -0.5|Mean Difference (Final Values)|0.2489|STANDARD_ERROR_OF_MEAN|0.168|||TWO_SIDED|98.7|-0.1301|0.2489|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus nelfilcon A.|The alternative hypothesis is that etaflicon A contact lenses have equal to or higher ratings of ease of handling than nelfilcon A contact lenses.||0.2489|-0.1301|
70980569|NCT03431012|141468774|OTHER||||||>|0.05||||||Sidak corrections were used to adjust for multiple analyses.|ANCOVA|ANCOVAs, setting baseline intentions as a covariate, were performed to determine whether post-exposure mean intentions differed between groups.||We predicted that Virus Agency (VA) and Positive Framing (PF) would lead to greater adherence intentions, compared to the human agency (HA) and negative framing (NF) versions respectively.||||>.05
70980570|NCT03431012|141468775|OTHER||||||=|0.113||||||Sidak corrections were used to adjust for multiple analyses.|MANOVA|||Based on the literature, it was predicted that the Virus Agency would lead to higher worry than the human agency assignment.||||=.113
70980571|NCT03431012|141468776|OTHER||||||=|0.809||||||Sidak corrections were used to adjust for multiple analyses|MANOVA|||Based on the literature, it was predicted that the Virus Agency would lead to higher perceptions of susceptibility than the human agency assignment.||||=.809
70980572|NCT03431012|141468777|OTHER|||||||0.025||||||Sidak corrections were used to adjust for multiple analyses.|MANOVA|||Based on the literature, it was predicted that the Virus Agency would lead to higher perceptions of severity of the pandemic than the human agency assignment.||||0.025
70980573|NCT03431012|141468778|OTHER||||||=|0.199||||||Sidak corrections were used to adjust for multiple analyses.|MANOVA|||Based on the literature, we predicted that the Agency Assignment would not affect self-efficacy, i.e. people's perceived ability to use the antivirals as recommended.||||=0.199
70980574|NCT03431012|141468779|OTHER||||||=|0.484||||||Sidak corrections were used to adjust for multiple analyses.|MANOVA|||Based on the literature, we predicted that Positive framing of the side effects would lead to higher response efficacy.||||=0.484
70980575|NCT03431012|141468780|OTHER||||||=|0.494||||||Sidak corrections were used to adjust for multiple analyses.|MANOVA|||Based on the literature, we predicted that Positive framing of the side effects would lead to lower response costs compared to Negative Framing.||||=0.494
70980576|NCT00929240|141468782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.383|||<|0.0001|TWO_SIDED|95.0|0.266|0.551||Stratified by interactive voice/Web response system (IVRS), estrogen receptor (ER) status, visceral metastasis (yes/no), response to initial phase, and lactate dehydrogenase (LDH) level.|Log Rank||Stratified by IVRS, ER status, visceral metastasis (yes/no), response to initial phase, and LDH level.|||0.551|0.266|<0.0001
70980577|NCT00929240|141468782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.429|||<|0.0001|TWO_SIDED|95.0|0.309|0.597|||Log Rank|Unstratified analysis||||0.597|0.309|<0.0001
70980578|NCT00929240|141468783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.1||||0.113|TWO_SIDED|95.0|-2.1|20.3|||Chi-squared||CIs with Hauck-Anderson adjustment for difference in rates of bevacizumab + capecitabine arm to bevacizumab alone arm.|||20.3|-2.1|0.113
70980579|NCT00929240|141468784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.58|TWO_SIDED|95.0|-2.6|4.6|||Chi-squared||CIs with Hauck-Anderson adjustment for difference in rates of Bevacizumab+Capecitabine group to Bevacizumab only group.|||4.6|-2.6|0.580
70980580|NCT00929240|141468786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.425|||<|0.0003|TWO_SIDED|95.0|0.263|0.685||Stratified by IVRS, ER status, visceral metastasis (yes/no), response to initial phase, and LDH level.|Log Rank|||||0.685|0.263|<0.0003
70980581|NCT00929240|141468786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.516||||0.002|TWO_SIDED|95.0|0.334|0.798||Unstratified analysis|Log Rank|||||0.798|0.334|0.002
70980582|NCT00929240|141468789|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.383|||<|0.0001|TWO_SIDED|95.0|0.266|0.551||Stratified by IVRS, ER status, visceral metastasis (yes/no), response to initial phase, and LDH level.|Log Rank||Stratification variables are randomisation stratification parameters as of IVRS: ER status, Visceral metastasis (yes/no), Response to initial phase, LDH concentration level.|||0.551|0.266|<0.0001
70980583|NCT00929240|141468789|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.425|||<|0.0001|TWO_SIDED|95.0|0.305|0.591||Unstratified analysis|Log Rank||Hazard ratio was determined using the cox regression model.|||0.591|0.305|<0.0001
70980584|NCT02371629|141468793|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.033|STANDARD_ERROR_OF_MEAN|0.0169||0.051|TWO_SIDED|95.0|0.0|0.066|||Mixed model for repeated measure (MMRM)|||||0.066|0.000|0.051
70980585|NCT00805207|141468808|OTHER|||||||0.85|||||||t-test, 2 sided|||||||0.85
70980586|NCT00805207|141468808|OTHER|||||||0.7|||||||t-test, 2 sided|||||||0.70
70980587|NCT00805207|141468808|OTHER|||||||0.88||||||P-value is the main effect of treatment (i.e., Before vs. After) from ANOVA|ANOVA|VLDL-TG secretion rates were skewed and log transformed prior to performing ANOVA||||||0.88
70980588|NCT00805207|141468808|OTHER|||||||0.26||||||P-value is the main effect of group (i.e., Testosterone, Progesterone, Estrogen and Control) from ANOVA|ANOVA|VLDL-TG secretion rates were skewed and log transformed prior to performing ANOVA||||||0.26
70980589|NCT00805207|141468808|OTHER|||||||0.98||||||P value is the group by treatment interaction from the ANOVA|ANOVA|VLDL-TG secretion rates were skewed and log transformed prior to performing ANOVA||||||0.98
70980590|NCT00805207|141468809|OTHER|||||||0.31|||||||t-test, 2 sided|||||||0.31
70980591|NCT00805207|141468809|OTHER|||||||0.82|||||||t-test, 2 sided|||||||0.82
70980592|NCT00805207|141468809|OTHER||||||<|0.05|||||||ANCOVA|||||||<0.05
70980593|NCT00805207|141468809|OTHER|||||||0.87|||||||ANCOVA|||||||0.87
70980594|NCT00805207|141468809|OTHER|||||||0.57|||||||ANCOVA|||||||0.57
70980595|NCT00805207|141468810|OTHER|||||||0.94|||||||t-test, 2 sided|||||||0.94
70980596|NCT00805207|141468810|OTHER||||||<|0.05|||||||ANCOVA|||||||<0.05
70980597|NCT00805207|141468810|OTHER|||||||0.53|||||||ANCOVA|||||||0.53
70980598|NCT00805207|141468810|OTHER|||||||0.23|||||||ANCOVA|||||||0.23
70980599|NCT00805207|141468811|OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.80
70980600|NCT00805207|141468812|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70980601|NCT00805207|141468812|OTHER||||||<|0.01||||||P-value is the main effect of treatment (i.e., Before vs. After) from ANOVA|ANOVA|||||||<0.01
71035531|NCT05133180|141579913|SUPERIORITY||adjusted mean difference|-4.732||||0.307|TWO_SIDED|95.0|-13.819|4.354||P-value of adjusted means difference between treatments from the ANCOVA model on change from baseline in SANDE score for severity at Week 12.|ANCOVA regression model|||This endpoint was analyzed by means of an ANCOVA adjusting by pre-defined baseline factors (treatment, gender, age class, baseline SANDE score for severity as fixed effects and site as random effect).||4.354|-13.819|0.307
70980602|NCT00805207|141468812|OTHER|||||||0.96||||||P-value is the main effect of group (i.e., Testosterone, Progesterone, Estrogen and Control) from ANOVA|ANOVA|||||||0.96
71035532|NCT05133180|141579914|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|2.16||||0.468|TWO_SIDED|95.0|-3.668|7.988||P-value of Least Square (LS) means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Daily Activities) at Week 4|MMRM|||Impact on daily activities at week 4.||7.988|-3.668|0.468
70980603|NCT00805207|141468812|OTHER||||||<|0.05||||||P value is the group by treatment interaction from the ANOVA|ANOVA|||||||<0.05
70980604|NCT00805207|141468812|OTHER||||||<|0.01|||||||Tukey test|||||||<0.01
70980605|NCT00805207|141468812|OTHER||||||<|0.01|||||||Tukey test|||||||<0.01
70980606|NCT00805207|141468812|OTHER||||||>|0.1|||||||Tukey test|||||||>0.10
70980607|NCT00805207|141468812|OTHER||||||>|0.1|||||||Tukey test|||||||>0.10
70980608|NCT02469246|141468813|NON_INFERIORITY|Non-inferiority was assessed using a 2-sided exact 95% confidence interval (CI) approach, with a non-inferiority margin of 10%.|Difference in Percentages|-3.8||||0.15|TWO_SIDED|95.002|-8.9|1.1|||Fisher Exact||The difference in percentages and its 95.002% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of the primary efficacy endpoint was to assess the noninferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.||1.1|-8.9|0.15
70980609|NCT02469246|141468814|NON_INFERIORITY|Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 4%.|Difference in Percentages|-6.3||||0.042|TWO_SIDED|95.0|-12.3|-0.3|||Fisher Exact||The difference in percentages and its 95% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of this efficacy endpoint was to assess the non-inferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.||-0.3|-12.3|0.042
70980610|NCT02469246|141468815|NON_INFERIORITY|Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 4%.|Difference in Percentages|1.1||||0.45|TWO_SIDED|95.002|-1.0|3.5|||Fisher Exact||The difference in percentages and its 95.002% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of this efficacy endpoint was to assess the non-inferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.||3.5|-1.0|0.45
70980611|NCT02469246|141468816|NON_INFERIORITY|Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 4%.|Difference in Percentages|1.4||||0.34|TWO_SIDED|95.0|-1.0|4.2|||Fisher Exact||The difference in percentages and its 95% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of this efficacy endpoint was to assess the non-inferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.||4.2|-1.0|0.34
70980612|NCT02469246|141468817|NON_INFERIORITY|Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 10%.|Difference in Percentages|-1.6||||0.62|TWO_SIDED|95.0|-7.4|4.2|||Fisher Exact||The difference in percentages and its 95% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of this efficacy endpoint was to assess the noninferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.||4.2|-7.4|0.62
70980613|NCT02469246|141468818|NON_INFERIORITY|Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 10%.|Difference in Percentages|-5.9||||0.069|TWO_SIDED|95.0|-12.2|0.4|||Fisher Exact||The difference in percentages and its 95% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of this efficacy endpoint was to assess the noninferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.||0.4|-12.2|0.069
70980614|NCT02469246|141468819|SUPERIORITY||Difference in LSM|-32.0||||0.026|TWO_SIDED|95.0|-61.0|-4.0||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).|||-4|-61|0.026
70980615|NCT02469246|141468820|SUPERIORITY||Difference in LSM|-39.0||||0.013|TWO_SIDED|95.0|-70.0|-8.0||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).|||-8|-70|0.013
70980616|NCT02469246|141468821|SUPERIORITY||Difference in LSM|0.179||||0.4|TWO_SIDED|95.0|-0.24|0.598||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).|||0.598|-0.240|0.40
70980617|NCT02469246|141468822|SUPERIORITY||Difference in LSM|0.165||||0.53|TWO_SIDED|95.0|-0.348|0.678||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).|||0.678|-0.348|0.53
70980618|NCT02469246|141468823|SUPERIORITY||Difference in LSM|0.151||||0.63|TWO_SIDED|95.0|-0.465|0.767||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).|||0.767|-0.465|0.63
70980619|NCT02469246|141468824|SUPERIORITY||Difference in LSM|-0.056||||0.89|TWO_SIDED|95.0|-0.825|0.713||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).|||0.713|-0.825|0.89
70980620|NCT04898166|141468847|SUPERIORITY|||||||0|||||||Chi-squared|Chi-square value 18.90 and its asymptotic significance .000||||||0.000
70980621|NCT04898166|141468848|SUPERIORITY|||||||0.081|||||||Chi-squared|Chi-square value 7.544 and its asymptotic significance .273||||||0.081
70980622|NCT04325503|141468943|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|0.0905||||0.015|TWO_SIDED|95.0|0.022|0.159||A priori threshold statistical significance p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 9||||0.159|0.022|0.015
70980623|NCT04325503|141468944|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|0.333||||0.694|TWO_SIDED|95.0|-1.55|2.216||A priori threshold for statistical significance is p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 8||||2.216|-1.550|0.694
70980624|NCT04325503|141468945|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|1.444||||0.103|TWO_SIDED|95.0|-0.363|3.252||A priori threshold for statistical significance was p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 8||||3.252|-0.363|0.103
70980625|NCT04325503|141468946|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|-2.09||||0.321|TWO_SIDED|95.0|-6.554|2.372||A priori threshold for statistical significance p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 10||||2.372|-6.554|0.321
71096709|NCT05788328|141702522|OTHER||Ratio of Adjusted Geometric Means|85.65|||||TWO_SIDED|90.0|64.96|112.94|||||Ratio was of test to reference of adjusted geometric means. Reference arm was DE 150mg (Period 1) and test arm was PF-07081532 80mg QD + DE 150mg (Period 4). Ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||112.94|64.96|
70980626|NCT04325503|141468947|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|0.185||||0.265|TWO_SIDED|95.0|-0.175|0.544|||t-test, 2 sided|Paired samples t-test, df = 7||||0.544|-0.175|0.265
70980627|NCT04325503|141468948|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|8.143||||0.027|TWO_SIDED|95.0|1.296|15.0||A priori threshold for statistical significance p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 6||||15.0|1.296|0.0270
70980628|NCT04325503|141468949|OTHER|A comparison is not being made between two different treatment groups.||||||0.153||||||A priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.153
70980629|NCT00144170|141468965|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.5||||0.0001|TWO_SIDED|95.0|12.9|24.0|||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||24.0|12.9|0.0001
70980630|NCT00144170|141468966|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
70980631|NCT00144170|141468967|SUPERIORITY_OR_OTHER||Risk Difference (RD)|24.9||||0.0001|TWO_SIDED|95.0|18.6|31.1|||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||31.1|18.6|0.0001
70980632|NCT00144170|141468968|SUPERIORITY_OR_OTHER||Risk Difference (RD)|28.8||||0.0001|TWO_SIDED|95.0|22.5|35.1|||Cochran-Mantel-Haenszel|||||35.1|22.5|0.0001
70980633|NCT00144170|141468969|SUPERIORITY_OR_OTHER||Risk Difference (RD)|29.4||||0.0001|TWO_SIDED|95.0|23.2|35.7|||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||35.7|23.2|0.0001
70980634|NCT00144170|141468970|SUPERIORITY_OR_OTHER||Risk Difference (RD)|26.6||||0.0001|TWO_SIDED|95.0|20.5|32.6|||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||32.6|20.5|0.0001
70980635|NCT00144170|141468971|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.1||||0.0001|TWO_SIDED|95.0|16.2|27.9|||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||27.9|16.2|0.0001
70980636|NCT00144170|141468972|SUPERIORITY_OR_OTHER||Risk Difference (RD)|19.0||||0.0001|TWO_SIDED|95.0|13.3|24.7||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||24.7|13.3|0.0001
70980637|NCT00144170|141468973|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.7||||0.0001|TWO_SIDED|95.0|13.0|24.4||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||24.4|13.0|0.0001
70980638|NCT00144170|141468974|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.2||||0.0001|TWO_SIDED|95.0|11.7|22.7||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||22.7|11.7|0.0001
70980639|NCT00144170|141468975|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.1||||0.0001|TWO_SIDED|95.0|11.7|22.4||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||22.4|11.7|0.0001
70980640|NCT00144170|141468976|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.3||||0.0001|TWO_SIDED|95.0|12.0|22.5||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||22.5|12.0|0.0001
70980641|NCT00144170|141468977|SUPERIORITY_OR_OTHER||Risk Difference (RD)|16.4||||0.0001|TWO_SIDED|95.0|11.2|21.5||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||21.5|11.2|0.0001
70980642|NCT00144170|141468978|SUPERIORITY_OR_OTHER||Risk Difference (RD)|16.2||||0.0001|TWO_SIDED|95.0|11.1|21.3||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||21.3|11.1|0.0001
70980643|NCT00144170|141468979|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.6||||0.0001|TWO_SIDED|95.0|10.6|20.6||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||20.6|10.6|0.0001
70980644|NCT00144170|141468980|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
70980645|NCT00144170|141468981|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
70980646|NCT00144170|141468982|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
70980647|NCT00144170|141469056|SUPERIORITY_OR_OTHER|||||||0.1026||95.0|||||Log Rank|||||||0.1026
70980648|NCT01564784|141469063|SUPERIORITY_OR_OTHER||Rate difference|51.4|||<|0.0001|TWO_SIDED|97.5|38.4|64.3|||1-sided p-value based on Chi-square test|If any cell count was \<5, p-value was based on Fisher's exact test||||64.3|38.4|<0.0001
70980649|NCT01564784|141469064|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.751||||0.0105|TWO_SIDED|97.5|0.568|0.993|||1-sided stratified log-rank p-value||Stratified HR, i.e., based on analysis stratified by randomization stratification factors.|||0.993|0.568|0.0105
70980650|NCT01564784|141469065|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49||||0.0021|TWO_SIDED|95.0|0.297|0.809|||1-sided stratified log-rank p-value||Stratified HR, i.e., based on analysis stratified by randomization stratification factors.|||0.809|0.297|0.0021
70980651|NCT01564784|141469066|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|97.5|0.336|0.602|||1-sided stratified log-rank p-value||Stratified HR, i.e., based on analysis stratified by randomization stratification factors.|||0.602|0.336|<0.0001
70980652|NCT01564784|141469067|SUPERIORITY_OR_OTHER||Rate difference|31.6|||<|0.0001|TWO_SIDED|95.0|22.6|40.6|||1-sided p-value based on Chi-square test|If any cell count was \<5, p-value was based on Fisher's exact test||||40.6|22.6|<0.0001
70980653|NCT01564784|141469068|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||1-sided p-value based on Chi-Square test|If any cell count is \<5, p-value was based on Fisher's exact test||||||<0.0001
70980654|NCT01564784|141469069|SUPERIORITY_OR_OTHER|||||||0.3168|||||||1-sided p-value based on Chi-Square test|If any cell count is \<5, p-value was based on Fisher's exact test||Abnormal at Screening||||0.3168
70980655|NCT01564784|141469069|SUPERIORITY_OR_OTHER|||||||0.216|||||||1-sided p-value based on Chi-Square test|If any cell count is \<5, p-value was based on Fisher's exact test||Abnormal after remission||||0.2160
70980656|NCT01564784|141469071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.9||||0.0139|TWO_SIDED|95.0|1.4|12.3|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Physical Functioning||12.3|1.4|0.0139
70980657|NCT01564784|141469071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.4||||0.0065|TWO_SIDED|95.0|3.2|19.5|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Role Functioning||19.5|3.2|0.0065
70980658|NCT01564784|141469071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3||||0.3307|TWO_SIDED|95.0|-6.9|2.3|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Emotional Functioning||2.3|-6.9|0.3307
70980659|NCT01564784|141469071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.8||||0.1904|TWO_SIDED|95.0|-1.4|7.0|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Cognitive Functioning||7.0|-1.4|0.1904
70980660|NCT01564784|141469071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.4||||0.0336|TWO_SIDED|95.0|0.7|16.1|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Social Functioning||16.1|0.7|0.0336
70980661|NCT01564784|141469071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.3||||0.1572|TWO_SIDED|95.0|-1.7|10.3|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Global Health Status||10.3|-1.7|0.1572
70980662|NCT01564784|141469071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7||||0.1281|TWO_SIDED|95.0|-10.8|1.4|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Dyspnoea||1.4|-10.8|0.1281
70980663|NCT01564784|141469071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.6207|TWO_SIDED|95.0|-8.7|5.2|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Insomnia||5.2|-8.7|0.6207
70980664|NCT01564784|141469071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.7||||0.0193|TWO_SIDED|95.0|-16.0|-1.4|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Appetite Loss||-1.4|-16.0|0.0193
70980665|NCT01564784|141469071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4||||0.6249|TWO_SIDED|95.0|-4.4|7.3|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Constipation||7.3|-4.4|0.6249
70980666|NCT01564784|141469071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0||||0.1534|TWO_SIDED|95.0|-7.2|1.1|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Diarrhoea||1.1|-7.2|0.1534
70980667|NCT01564784|141469071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.5||||0.4915|TWO_SIDED|95.0|-9.7|4.7|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Financial Difficulties||4.7|-9.7|0.4915
70980668|NCT01564784|141469071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.4||||0.1789|TWO_SIDED|95.0|-10.8|2.0|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Fatigue||2.0|-10.8|0.1789
70980669|NCT01564784|141469071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.4578|TWO_SIDED|95.0|-6.0|2.7|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Nausea and Vomiting||2.7|-6.0|0.4578
70980670|NCT01564784|141469071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.8428|TWO_SIDED|95.0|-7.3|6.0|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Pain||6.0|-7.3|0.8428
70980671|NCT01564784|141469072|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.171|TWO_SIDED|95.0|-0.01|0.07|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||||0.07|-0.01|0.1710
70980672|NCT01564784|141469073|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.6||||0.1172|TWO_SIDED|95.0|-1.2|10.4|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||||10.4|-1.2|0.1172
71096710|NCT05788328|141702522|OTHER||Ratio of Adjusted Geometric Means|80.81|||||TWO_SIDED|90.0|61.28|106.55|||||Ratio was of test to reference of adjusted geometric means. Reference arm was DE 150mg (Period 1) and test arm was PF-07081532 240mg QD + DE 150mg (Period 7). Ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||106.55|61.28|
71096711|NCT05788328|141702523|OTHER||Ratio of Adjusted Geometric Means|229.11|||||TWO_SIDED|90.0|185.23|283.37|||||Ratio was of test to reference of adjusted geometric means. The reference arm was rosuvastatin 10 mg (Period 2) and test arm was PF-07081532 80 mg QD+rosuvastatin 10 mg (Period 5). The ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||283.37|185.23|
70980673|NCT05202808|141469077|NON_INFERIORITY|"The endothelial cell loss (ECL) at 6 months was compared between the LAL and Control groups. The statistical hypothesis is:~* H0: Median(LAL) - Median(control) ≥ 5% vs~* Ha: Median(LAL) - Median(control) \< 5%~The median ECL for the LAL group is at most 5% higher than the median ECL for the Control group.~The first co-primary safety endpoint is met if the median ECL of the LAL group is non-inferior to the Control group using a right-tail Wilcoxon test using a significance level of 0.05."|Median Difference (Final Values)|0.2|||<|0.0001|TWO_SIDED|90.0|-1.0|1.66|||Wilcoxon (Mann-Whitney)|||With a one-sided significance level of 0.05, a power of 0.80, a randomization ratio of 2:1, and then the Mann-Whitney-Wilcoxon asymptotic relative efficiency (A.R.E.) efficiency adjustment, the sample size per two-sample t-test is 192 LAL eyes and 96 Control eyes (total of 288), with an assumed dropout rate of 10%.||1.66|-1.00|<0.0001
70980674|NCT05202808|141469079|OTHER||Odds Ratio (OR)|4.61|||||TWO_SIDED|95.0|2.97|7.15|||||Light adjustable lens (LAL) and Light Delivery Device (LDD) group is the numerator and Control group is the denominator. At Month 6, the odds of achieving UCDVA of 20/20 or better were 4.61 times greater for the LAL group than the Control group.|||7.15|2.97|
71096712|NCT05788328|141702523|OTHER||Ratio of Adjusted Geometric Means|214.73|||||TWO_SIDED|90.0|173.38|265.94|||||Ratio was of test to reference of adjusted geometric means. The reference arm was rosuvastatin 10 mg (Period 2) and test arm was PF-07081532 240 mg QD+rosuvastatin 10 mg (Period 8). The ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||265.94|173.38|
70980675|NCT05202808|141469080|OTHER||Odds Ratio (OR)|20.74|||||TWO_SIDED|95.0|12.05|36.14|||||Light adjustable lens (LAL) and Light Delivery Device (LDD) group is the numerator and the Control group is the denominator. The odds of achieving Absolute MRCYL of 0.5D or less was 20.74 for the LAL group versus the Control group at month 6.|||36.14|12.05|
70980676|NCT05202808|141469081|OTHER||Odds Ratio (OR)|14.46|||||TWO_SIDED|95.0|8.89|23.57|||||Light adjustable lens (LAL) and Light Delivery Device (LDD) group is the numerator and the Control group is the denominator. The odds of achieving simultaneous Absolute MRSE and MRCL of 0.5 D or less was 14.46 in the LAL group vs. Control at month 6.|||23.57|8.89|
70980677|NCT00741819|141469086|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|16.0|STANDARD_DEVIATION|35.9|<|0.001||95.0|||||Wilcoxon signed rank test]||Change in 6MWD from Baseline was calculated for patients still remaining on study at Week 12.|Analysis of endpoints was descriptive in nature. Numeric endpoints for post-baseline assessments were compared to Baseline using Wilcoxon signed rank test, and p-values were calculated for descriptive purposes; no formal hypothesis testing was planned.||||<0.001
70980678|NCT00741819|141469087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.4|STANDARD_DEVIATION|7.7|<|0.001|||||||Wilcoxon signed rank test||Analysis based on Total CAMPHOR Score.|||||<0.001
70980679|NCT00741819|141469088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|21.3||0.895||95.0|||||Wilcoxon signed-rank test||Side-Effects Score, change from Baseline to Week 12|||||0.895
70980680|NCT00741819|141469088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.3|STANDARD_DEVIATION|25.9|<|0.001||95.0|||||Wilcoxon signed-rank test||Convenience Score, change from Baseline to Week 12|||||<0.001
70980681|NCT00741819|141469088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.0|STANDARD_DEVIATION|23.7|<|0.001||95.0|||||Wilcoxon signed-rank test||Global Satisfaction, change from Baseline to Week 12|||||<0.001
70980682|NCT00741819|141469088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.9|STANDARD_DEVIATION|21.5|<|0.001||95.0|||||Wilcoxon signed rank test||Effectiveness score, change from Baseline to Week 12|||||<0.001
70980683|NCT00741819|141469090|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon signed-rank test|||||||0.001
70980684|NCT01245647|141469127|SUPERIORITY_OR_OTHER|||||||0.82|||||||t-test, 2 sided|||||||0.82
70980685|NCT01245647|141469128|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
70980686|NCT01245647|141469129|SUPERIORITY_OR_OTHER|||||||0.46|||||||Fisher Exact|||||||0.46
70980687|NCT01245647|141469130|SUPERIORITY_OR_OTHER|||||||0.12||||||no significant difference by Fisher exact test|Fisher Exact|||||||0.12
70980688|NCT01245647|141469131|SUPERIORITY_OR_OTHER|||||||0.67|||||||t-test, 2 sided|||||||0.67
70980689|NCT02370121|141469132|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
70980690|NCT02370121|141469133|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
70980691|NCT02370121|141469134|SUPERIORITY_OR_OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
70980692|NCT02370121|141469135|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
70980693|NCT02370121|141469136|SUPERIORITY_OR_OTHER|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
70980694|NCT02370121|141469137|SUPERIORITY_OR_OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.92
70980695|NCT02370121|141469138|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
70980696|NCT02370121|141469139|SUPERIORITY_OR_OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
70980697|NCT02370121|141469140|SUPERIORITY_OR_OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
70980698|NCT02370121|141469141|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
71096713|NCT05788328|141702524|OTHER||Ratio of Adjusted Geometric Means|213.05|||||TWO_SIDED|90.0|170.46|266.29|||||Ratio was of test to reference of adjusted geometric means. The reference arm was rosuvastatin 10 mg (Period 2) and test arm was PF-07081532 80 mg QD+rosuvastatin 10 mg (Period 5). The ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||266.29|170.46|
71096714|NCT05788328|141702524|OTHER||Ratio of Adjusted Geometric Means|232.32|||||TWO_SIDED|90.0|185.88|290.38|||||Ratio was of test to reference of adjusted geometric means. The reference arm was rosuvastatin 10 mg (Period 2) and test arm was PF-07081532 240 mg QD+rosuvastatin 10 mg (Period 8). The ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||290.38|185.88|
71096715|NCT05788328|141702532|OTHER||Ratio of Adjusted Geometric Means|45.25|||||TWO_SIDED|90.0|33.97|60.27|||||Ratio was of test to reference of adjusted geometric means. Reference arm was DE 150mg (Period 1) and test arm was PF-07081532 80mg QD + DE 150mg (Period 4). Ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||60.27|33.97|
71096716|NCT05788328|141702532|OTHER||Ratio of Adjusted Geometric Means|47.44|||||TWO_SIDED|90.0|35.62|63.19|||||Ratio was of test to reference of adjusted geometric means. Reference arm was DE 150mg (Period 1) and test arm was PF-07081532 240mg QD + DE 150mg (Period 7). Ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||63.19|35.62|
71096717|NCT05788328|141702537|OTHER||Ratio of Adjusted Geometric Means|176.39|||||TWO_SIDED|90.0|135.51|229.6|||||Ratio was of test to reference of adjusted geometric means. The reference arm was rosuvastatin 10 mg (Period 2) and test arm was PF-07081532 80 mg QD+rosuvastatin 10 mg (Period 5). The ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||229.60|135.51|
71096718|NCT05788328|141702537|OTHER||Ratio of Adjusted Geometric Means|221.62|||||TWO_SIDED|90.0|170.26|288.48|||||Ratio was of test to reference of adjusted geometric means. The reference arm was rosuvastatin 10 mg (Period 2) and test arm was PF-07081532 240 mg QD+rosuvastatin 10 mg (Period 8). The ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||288.48|170.26|
70980699|NCT02370121|141469142|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
70980700|NCT02370121|141469143|SUPERIORITY_OR_OTHER|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||||||0.83
70980701|NCT02370121|141469144|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
70980702|NCT02370121|141469145|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
70980703|NCT02370121|141469146|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
70980704|NCT02370121|141469147|SUPERIORITY_OR_OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
70980705|NCT02370121|141469148|SUPERIORITY_OR_OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
70980706|NCT00275561|141469159|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||Fisher Exact|||||||0.74
70980707|NCT00275561|141469160|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||Fisher Exact|||||||0.49
71035533|NCT05133180|141579914|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|2.431||||0.492|TWO_SIDED|95.0|-4.5|9.362||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Emotional Impact) at Week 4.|MMRM|||Emotional Impact due to Dry eye at week 4.||9.362|-4.500|0.492
71096719|NCT02357485|141702553|SUPERIORITY_OR_OTHER||||||<|0.004|TWO_SIDED|||||Baseline vs 1 year Post-treatment|t-test, 2 sided|||||||<0.004
71096720|NCT02357485|141702554|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Baseline vs 1 year Post-treatment|t-test, 2 sided|||||||<0.001
71096721|NCT02357485|141702555|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED||||||t-test, 2 sided|||||||0.053
71096722|NCT02357485|141702556|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|||||||0.003
71096723|NCT02802865|141702573|SUPERIORITY||Rate ratio|1.8||||0.007|TWO_SIDED|95.0|1.18|2.75|||Chi-squared, Corrected|||||2.75|1.18|0.007
71096724|NCT02802865|141702574|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71096725|NCT02802865|141702575|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
70980708|NCT00275561|141469161|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
70980709|NCT04321343|141469170|SUPERIORITY||Mean Difference (Final Values)|-25.313|STANDARD_ERROR_OF_MEAN|9.587||0.0083|TWO_SIDED|95.0|-44.1036|-6.5227|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||-6.5227|-44.1036|0.0083
70980710|NCT04321343|141469170|SUPERIORITY||Mean Difference (Final Values)|-21.003|STANDARD_ERROR_OF_MEAN|9.287||0.0237|TWO_SIDED|95.0|-39.2074|-2.7991|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||-2.7991|-39.2074|0.0237
70980711|NCT04321343|141469170|SUPERIORITY||Mean Difference (Final Values)|-23.748|STANDARD_ERROR_OF_MEAN|9.053||0.0087|TWO_SIDED|95.0|-41.4923|-6.0035|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||-6.0035|-41.4923|0.0087
70980712|NCT04321343|141469171|SUPERIORITY||Hodges-Lehmann midpoint estimate|-26.226|STANDARD_ERROR_OF_MEAN|10.252||0.0105|TWO_SIDED|95.0|-46.3208|-6.1313|||Wilcoxon (Mann-Whitney)|Non-parametric pairwaise Wilcoxon tests using a multiple imputation procedure based on the fully conditional specification method.||||-6.1313|-46.3208|0.0105
70980713|NCT04321343|141469171|SUPERIORITY||Hodges-Lehmann midpoint estimate|-21.496|STANDARD_ERROR_OF_MEAN|9.873||0.0295|TWO_SIDED|95.0|-40.8475|-2.1451|||Wilcoxon (Mann-Whitney)|Non-parametric pairwaise Wilcoxon tests using a multiple imputation procedure based on the fully conditional specification method.||||-2.1451|-40.8475|0.0295
70980714|NCT04321343|141469171|SUPERIORITY||Hodges-Lehmann midpoint estimate|-24.29|STANDARD_ERROR_OF_MEAN|9.746||0.0127|TWO_SIDED|95.0|-43.392|-5.1884|||Wilcoxon (Mann-Whitney)|Non-parametric pairwaise Wilcoxon tests using a multiple imputation procedure based on the fully conditional specification method.||||-5.1884|-43.3920|0.0127
71096726|NCT02802865|141702576|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||0.006
71096727|NCT02802865|141702577|SUPERIORITY|||||||0.709|||||||Chi-squared|||This study was not powered to detect significant between-group differences for this conception.||||0.709
71096728|NCT02802865|141702578|SUPERIORITY|||||||0.356|||||||Chi-squared|||This study was not powered to detect significant between-group differences for clinical pregnancy.||||0.356
71096729|NCT02802865|141702580|SUPERIORITY|||||||0.356|||||||Chi-squared|||This study was not powered to detect significant between-group differences for live birth.||||0.356
71096730|NCT02802865|141702581|SUPERIORITY|||||||0.486|||||||Chi-squared, Corrected|||This study was not powered to detect significant between-group differences for pregnancy loss.||||0.486
70980715|NCT04321343|141469172|SUPERIORITY||Mean Difference (Final Values)|-4.671|STANDARD_ERROR_OF_MEAN|1.824||0.0105|TWO_SIDED|95.0|-8.2463|-1.0957|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||-1.0957|-8.2463|0.0105
70980716|NCT04321343|141469172|SUPERIORITY||Mean Difference (Final Values)|-4.097|STANDARD_ERROR_OF_MEAN|1.743||0.0188|TWO_SIDED|95.0|-7.514|-0.6799|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||-0.6799|-7.5140|0.0188
70980717|NCT04321343|141469172|SUPERIORITY||Mean Difference (Final Values)|-4.321|STANDARD_ERROR_OF_MEAN|1.689||0.0105|TWO_SIDED|95.0|-7.6307|-1.0104|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||-1.0104|-7.6307|0.0105
70980718|NCT04321343|141469173|SUPERIORITY||Odds Ratio (OR)|2.61||||0.1634|TWO_SIDED|95.0|0.677|10.087|||Cochran-Mantel-Haenszel|CMH with multiple imputation||||10.087|0.677|0.1634
70980719|NCT04321343|141469173|SUPERIORITY||Odds Ratio (OR)|3.26||||0.0722|TWO_SIDED|95.0|0.899|11.831|||Cochran-Mantel-Haenszel|CMH with multiple imputation||||11.831|0.899|0.0722
70980720|NCT04321343|141469173|SUPERIORITY||Odds Ratio (OR)|3.17||||0.0703|TWO_SIDED|95.0|0.909|11.052|||Cochran-Mantel-Haenszel|CMH with multiple imputation||||11.052|0.909|0.0703
70980721|NCT04321343|141469174|SUPERIORITY||Mean Difference (Final Values)|-6.5|STANDARD_ERROR_OF_MEAN|8.2||0.4318|TWO_SIDED|95.0|-22.66|9.72|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||9.72|-22.66|0.4318
70980722|NCT04321343|141469174|SUPERIORITY||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|8.0||0.8382|TWO_SIDED|95.0|-17.37|14.1|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||14.10|-17.37|0.8382
70980723|NCT04321343|141469174|SUPERIORITY||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|7.7||0.4982|TWO_SIDED|95.0|-9.92|20.33|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||20.33|-9.92|0.4982
70980724|NCT04321343|141469175|SUPERIORITY||Odds Ratio (OR)|0.72||||0.7137|TWO_SIDED|95.0|0.131|3.935|||Cochran-Mantel-Haenszel|||||3.935|0.131|0.7137
70980725|NCT04321343|141469175|SUPERIORITY||Odds Ratio (OR)|3.7||||0.0597|TWO_SIDED|95.0|0.937|14.58|||Cochran-Mantel-Haenszel|||||14.580|0.937|0.0597
70980726|NCT04321343|141469175|SUPERIORITY||Odds Ratio (OR)|2.61||||0.1749|TWO_SIDED|95.0|0.655|10.43|||Cochran-Mantel-Haenszel|||||10.430|0.655|0.1749
70980727|NCT04321343|141469176|SUPERIORITY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|8.8||0.7449|TWO_SIDED|95.0|-20.15|14.43|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||14.43|-20.15|0.7449
70980728|NCT04321343|141469176|SUPERIORITY||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|8.6||0.7255|TWO_SIDED|95.0|-19.93|13.9|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||13.90|-19.93|0.7255
70980729|NCT04321343|141469176|SUPERIORITY||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|8.2||0.7755|TWO_SIDED|95.0|-13.89|18.59|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||18.59|-13.89|0.7755
71096731|NCT01454063|141702589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.577|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001||95.0|0.475|0.678||p-value based on the generalized Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata.|Cochran-Mantel-Haenszel|CMH-weighted mean difference (OMS - Placebo) adjusted for randomization strata.||||0.678|0.475|<0.0001
70980730|NCT04321343|141469177|SUPERIORITY||Odds Ratio (OR)|3.12||||0.1325|TWO_SIDED|95.0|0.703|13.806|||Cochran-Mantel-Haenszel|||||13.806|0.703|0.1325
70980731|NCT04321343|141469177|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9918|TWO_SIDED|95.0|0.201|4.898|||Cochran-Mantel-Haenszel|||||4.898|0.201|0.9918
70980732|NCT04321343|141469177|SUPERIORITY||Odds Ratio (OR)|4.78||||0.041|TWO_SIDED|95.0|1.053|21.714|||Cochran-Mantel-Haenszel|||||21.714|1.053|0.0410
70980733|NCT04321343|141469178|SUPERIORITY||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|10.3||0.4413|TWO_SIDED|95.0|-28.25|12.36|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||12.36|-28.25|0.4413
70980734|NCT04321343|141469178|SUPERIORITY||Mean Difference (Final Values)|-17.6|STANDARD_ERROR_OF_MEAN|10.2||0.0859|TWO_SIDED|95.0|-37.63|2.5|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||2.50|-37.63|0.0859
70980735|NCT04321343|141469178|SUPERIORITY||Median Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|10.0||0.7887|TWO_SIDED|95.0|-22.31|16.97|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||16.97|-22.31|0.7887
70980736|NCT04321343|141469179|SUPERIORITY||Mean Difference (Final Values)|-5.9|STANDARD_ERROR_OF_MEAN|3.7||0.1166|TWO_SIDED|95.0|-13.19|1.47|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||1.47|-13.19|0.1166
71096732|NCT01454063|141702590|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.199|STANDARD_ERROR_OF_MEAN|1.076|<|0.0001||95.0|-7.307|-3.091||p-value based on the generalized CMH test stratified by randomization strata.|Cochran-Mantel-Haenszel|CMH-weighted mean difference (OMS302-placebo) adjusted for randomization strata.||||-3.091|-7.307|<0.0001
71096733|NCT01454063|141702591|SUPERIORITY_OR_OTHER|||||||0.0514||||||Treatment comparisons based on CMH test adjusting for randomization strata.|Cochran-Mantel-Haenszel|||||||0.0514
71096734|NCT01454063|141702592|SUPERIORITY_OR_OTHER|||||||0.0034||||||Treatment comparisons based on CMH test adjusting for the randomization strata.|Cochran-Mantel-Haenszel|||||||0.0034
71035534|NCT05133180|141579914|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM). Analyses included the fixed, categorical effects of treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall. Missing data will be imputed according to the questionnaire manuals"|LS means difference|3.3||||0.51|TWO_SIDED|95.0|-6.511|13.111||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Impact on Work) at Week 4.|MMRM|||Impact on Work due to Dry Eye at week 4.||13.111|-6.511|0.510
71035535|NCT05133180|141579914|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|Least square mean difference|4.078||||0.268|TWO_SIDED|95.0|-3.142|11.299||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Daily Activities) at Week 12.|MMRM|||Quality of life - Impact on daily activities - Week 12||11.299|-3.142|0.268
71035536|NCT05133180|141579914|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall"|least square mean difference|5.55||||0.227|TWO_SIDED|95.0|-3.462|14.562||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Emotional Impact) at Week 12.|MMRM|||Quality of life - Emotional Impact due to Dry eye - Week 12||14.562|-3.462|0.227
71035537|NCT05133180|141579914|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|3.475||||0.501|TWO_SIDED|95.0|-6.651|13.601||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Impact on Work) at Week 12.|MMRM|||Quality of life - Impact on Work due to Dry Eye - Week 12||13.601|-6.651|0.501
71035538|NCT05133180|141579915|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|-0.549||||0.924|TWO_SIDED|95.0|-11.82|10.723||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Treatment Satisfaction \& Bother module (Satisfaction with Treatment Effectiveness) at Week 4.|MMRM|||IDEEL Treatment satisfaction \& Bother Module Satisfaction with Treatment Effectiveness - week 4||10.723|-11.820|0.924
71035539|NCT05133180|141579915|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|1.072||||0.745|TWO_SIDED|95.0|-5.398|7.542||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Treatment Satisfaction \& Bother module (Treatment- Related Bother / Inconvenience) at Week 4.|MMRM|||IDEEL Treatment satisfaction \& Bother Module - Treatment- Related Bother / Inconvenience - week 4||7.542|-5.398|0.745
71035540|NCT05133180|141579915|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM)adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|-4.206||||0.467|TWO_SIDED|95.0|-15.53|7.118||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Treatment Satisfaction \& Bother module (Satisfaction with Treatment Effectiveness) at Week 12.|MMRM|||IDEEL Treatment satisfaction \& Bother Module - Satisfaction with Treatment Effectiveness - week 12||7.118|-15.530|0.467
70980737|NCT04321343|141469179|SUPERIORITY||Mean Difference (Final Values)|-11.0|STANDARD_ERROR_OF_MEAN|3.7||0.003|TWO_SIDED|95.0|-18.26|-3.8|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-3.80|-18.26|0.0030
70980738|NCT04321343|141469179|SUPERIORITY||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|3.5||0.0131|TWO_SIDED|95.0|-15.79|-1.87|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-1.87|-15.79|0.0131
71096735|NCT01454063|141702593|SUPERIORITY_OR_OTHER|||||||0.0963||||||Treatment comparisons based on Wilcoxon rank-sum test stratified by randomization strata. For subjects without a score due to inability to read the ETDRS chart, the log score will be imputed as 1.6 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.0963
70980739|NCT04321343|141469180|SUPERIORITY||Mean Difference (Final Values)|-1.013|STANDARD_ERROR_OF_MEAN|1.481||0.4963|TWO_SIDED|95.0|-3.9701|1.9436|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||1.9436|-3.9701|0.4963
71096736|NCT01454063|141702594|SUPERIORITY_OR_OTHER|||||||0.0532||||||Treatment comparisons are based on generalized CMH test stratified by randomization strata.|Cochran-Mantel-Haenszel|||||||0.0532
71096737|NCT01454063|141702595|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Generalized CMH test stratified by randomization strata.|Cochran-Mantel-Haenszel|||||||<0.0001
71096738|NCT03055195|141702607|OTHER||Proportions Difference|11.0|||||TWO_SIDED|90.0|-1.1|23.3|||||Difference in Proportions between Mepolizumab 100 mg SC versus Placebo SC has been presented.|||23.3|-1.1|
71096739|NCT03055195|141702609|OTHER||Proportion Difference|-1.0|||||TWO_SIDED|90.0|-14.0|12.6|||||Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 4 has been presented.|||12.6|-14.0|
71096740|NCT03055195|141702609|OTHER||Proportion Difference|11.0|||||TWO_SIDED|90.0|-1.1|23.3|||||Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 8 has been presented.|||23.3|-1.1|
71096741|NCT03055195|141702609|OTHER||Proportion Difference|11.0|||||TWO_SIDED|90.0|-1.1|23.3|||||Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 12 has been presented.|||23.3|-1.1|
71096742|NCT03055195|141702609|OTHER||Proportion Difference|11.0|||||TWO_SIDED|90.0|-1.1|23.3|||||Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 16 has been presented.|||23.3|-1.1|
71096743|NCT03055195|141702609|OTHER||Proportion Difference|6.0|||||TWO_SIDED|90.0|-3.3|14.4|||||Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 20 has been presented.|||14.4|-3.3|
71096744|NCT00976391|141702649|NON_INFERIORITY_OR_EQUIVALENCE|P-value from a one-sided t-test to test whether the difference of least square means (albiglutide - preprandial lispro insulin) is less than or equal to the pre-specified non-inferiority margin of 0.4%|Mean Difference (Net)|-0.16|||<|0.0001|TWO_SIDED|95.0|-0.32|0.0|||t-test, 1 sided|||||0.00|-0.32|<0.0001
71096745|NCT00927186|141702663|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The pre-specified significance level 0.05 was used.|Wilcoxon (Mann-Whitney)|||||||<0.001
71096746|NCT00927186|141702664|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
71096747|NCT00927186|141702665|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
70980740|NCT04321343|141469180|SUPERIORITY||Mean Difference (Final Values)|-0.712|STANDARD_ERROR_OF_MEAN|1.402||0.6131|TWO_SIDED|95.0|-3.5109|2.0866|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||2.0866|-3.5109|0.6131
71096748|NCT00927186|141702665|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)|||||||0.002
71096749|NCT00927186|141702666|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
71096750|NCT00927186|141702666|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
71096751|NCT00927186|141702667|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.002
71096752|NCT00927186|141702667|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.002
71096753|NCT00927186|141702668|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
71096754|NCT00927186|141702668|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
71096755|NCT00927186|141702668|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.002
71096756|NCT00927186|141702668|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.002
71096757|NCT00927186|141702669|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
70980741|NCT04321343|141469180|SUPERIORITY||Mean Difference (Final Values)|-1.441|STANDARD_ERROR_OF_MEAN|1.362||0.2939|TWO_SIDED|95.0|-4.1593|1.2779|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||1.2779|-4.1593|0.2939
71096758|NCT00927186|141702669|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
71096759|NCT00927186|141702670|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.002
71096760|NCT00927186|141702670|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.002
71096761|NCT00927186|141702671|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
70980742|NCT04321343|141469181|SUPERIORITY||Mean Difference (Final Values)|-0.063|STANDARD_ERROR_OF_MEAN|0.211||0.7672|TWO_SIDED|95.0|-0.4845|0.3589|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.3589|-0.4845|0.7672
71096762|NCT00927186|141702671|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
71096763|NCT00927186|141702671|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.003
71096764|NCT00927186|141702671|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.002
71096765|NCT00927186|141702672|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
71096766|NCT00927186|141702672|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
71096767|NCT00927186|141702673|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.020
71096768|NCT00927186|141702673|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.005
71096769|NCT00927186|141702674|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
71035541|NCT05133180|141579915|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM)adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|2.244||||0.564|TWO_SIDED|95.0|-5.387|9.874||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Treatment Satisfaction \& Bother module (Treatment- Related Bother / Inconvenience) at Week 12.|MMRM|||IDEEL Treatment satisfaction \& Bother Module - Treatment- Related Bother / Inconvenience - week 12||9.874|-5.387|0.564
71035542|NCT05133180|141579916|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|-0.805||||0.802|TWO_SIDED|95.0|-7.086|5.476||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Symptom Bother Module at Week 4.|MMRM|||IDEEL - Symptom Bother module - week 4||5.476|-7.086|0.802
71035543|NCT05133180|141579916|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|-8.789||||0.019|TWO_SIDED|95.0|-16.16|-1.418||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Symptom Bother Module at Week 12.|MMRM|||IDEEL - Symptom Bother module - week 12||-1.418|-16.160|0.019
71035544|NCT05133180|141579917|SUPERIORITY||least square mean difference|-1.518||||0.045|TWO_SIDED|95.0|-3.005|-0.031||P-value of LS means difference between treatments from the MMRM on change from baseline in Cornea and conjunctiva vital staining with fluorescein NEI scale at Week 4.|MMRM|||Herein Week 4 was considered. The change from baseline in Cornea and conjunctiva vital staining with fluorescein NEI scale was analyzed by means of an MMRM adjusting by pre-defined factors (gender, age class, NEI scale baseline value, treatment, visit, and treatment by visit interaction; subject was considered as a random effect).||-0.031|-3.005|0.045
71035545|NCT05133180|141579917|SUPERIORITY||least square mean difference|-1.773||||0.038|TWO_SIDED|95.0|-3.446|-0.101||P-value of LS means difference between treatments from the MMRM on change from baseline in Cornea and conjunctiva vital staining with fluorescein NEI scale at Week 8.|MMRM|||Herein Week 8 was considered. The change from baseline in Cornea and conjunctiva vital staining with fluorescein NEI scale was analyzed by means of an MMRM adjusting by pre-defined factors (gender, age class, NEI scale baseline value, treatment, visit, and treatment by visit interaction; subject was considered as a random effect).||-0.101|-3.446|0.038
71035546|NCT05133180|141579917|SUPERIORITY||least square mean difference|-1.224||||0.2|TWO_SIDED|95.0|-3.096|0.649||P-value of LS means difference between treatments from the MMRM on change from baseline in Cornea and conjunctiva vital staining with fluorescein NEI scale at Week 12|MMRM|||Herein Week 12 was considered. The change from baseline in Cornea and conjunctiva vital staining with fluorescein NEI scale was analyzed by means of an MMRM adjusting by pre-defined factors (gender, age class, NEI scale baseline value, treatment, visit, and treatment by visit interaction; subject was considered as a random effect).||0.649|-3.096|0.200
71035547|NCT05133180|141579918|SUPERIORITY||least square mean difference|1.64||||0.016|TWO_SIDED|95.0|0.3|2.98||P-value of LS means difference between treatments from the MMRM on change from baseline in TFBUT at Week 4.|MMRM|||Herein week 4 was considered. The change from baseline in TFBUT values was analyzed by means of a MMRM adjusting by pre-defined factors (gender, age class, TFBUT baseline value, treatment, visit, and treatment by visit interaction; subject was considered as a random effect).||2.980|0.300|0.016
71035548|NCT05133180|141579918|SUPERIORITY||least ssquare mean difference|1.133||||0.129|TWO_SIDED|95.0|-0.329|2.596||P-value of LS means difference between treatments from the MMRM on change from baseline in TFBUT at Week 8.|MMRM|||Herein week 8 was considered. The change from baseline in TFBUT values was analyzed by means of a MMRM adjusting by pre-defined factors (gender, age class, TFBUT baseline value, treatment, visit, and treatment by visit interaction; subject was considered as a random effect).||2.596|-0.329|0.129
71035549|NCT05133180|141579918|SUPERIORITY||least square mean difference|1.36||||0.05|TWO_SIDED|95.0|-0.002|2.722||P-value of LS means difference between treatments from the MMRM on change from baseline in TFBUT at Week 12.|MMRM|||Herein week 12 was considered. The change from baseline in TFBUT values was analyzed by means of a MMRM adjusting by pre-defined factors (gender, age class, TFBUT baseline value, treatment, visit, and treatment by visit interaction; subject was considered as a random effect).||2.722|-0.002|0.050
71035550|NCT05133180|141579919|SUPERIORITY||||||<|0.001||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 4 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||<0.001
71096770|NCT00927186|141702674|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
71035551|NCT05133180|141579919|SUPERIORITY|||||||0.009||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants|Wilcoxon (Mann-Whitney)|||Herein Week 8 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.009
71096771|NCT00927186|141702674|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.039
71096772|NCT00927186|141702674|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.025
71096773|NCT00927186|141702675|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
71096774|NCT00927186|141702675|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
71096775|NCT00927186|141702676|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.050
70980743|NCT04321343|141469181|SUPERIORITY||Mean Difference (Final Values)|-0.127|STANDARD_ERROR_OF_MEAN|0.198||0.5233|TWO_SIDED|95.0|-0.5216|0.2678|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.2678|-0.5216|0.5233
70980744|NCT04321343|141469181|SUPERIORITY||Mean Difference (Final Values)|-0.279|STANDARD_ERROR_OF_MEAN|0.18||0.1263|TWO_SIDED|95.0|-0.6376|0.0805|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.0805|-0.6376|0.1263
70980745|NCT04321343|141469182|SUPERIORITY||Mean Difference (Final Values)|-0.028|STANDARD_ERROR_OF_MEAN|0.165||0.8662|TWO_SIDED|95.0|-0.3559|0.3002|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.3002|-0.3559|0.8662
70980746|NCT04321343|141469182|SUPERIORITY||Mean Difference (Final Values)|-0.094|STANDARD_ERROR_OF_MEAN|0.166||0.5726|TWO_SIDED|95.0|-0.4253|0.2369|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.2369|-0.4253|0.5726
70980747|NCT04321343|141469182|SUPERIORITY||Mean Difference (Final Values)|-0.186|STANDARD_ERROR_OF_MEAN|0.153||0.2289|TWO_SIDED|95.0|-0.4907|0.1192|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.1192|-0.4907|0.2289
71035552|NCT05133180|141579919|SUPERIORITY|||||||0.02||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 12 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.020
71035553|NCT05133180|141579919|SUPERIORITY|||||||0.022||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 16 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.022
71035554|NCT05133180|141579920|SUPERIORITY|||||||0.065||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants|Wilcoxon (Mann-Whitney)|||Herein Week 16 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.065
71096776|NCT00927186|141702676|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.016
71096777|NCT00927186|141702677|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
70980748|NCT04321343|141469183|SUPERIORITY||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.254||0.8595|TWO_SIDED|95.0|-0.5509|0.4607|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.4607|-0.5509|0.8595
70980749|NCT04321343|141469183|SUPERIORITY||Mean Difference (Final Values)|-0.222|STANDARD_ERROR_OF_MEAN|0.25||0.3776|TWO_SIDED|95.0|-0.7194|0.2759|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.2759|-0.7194|0.3776
71035555|NCT05133180|141579921|SUPERIORITY|||||||0.125||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein week 16 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.125
71035556|NCT05133180|141579922|SUPERIORITY|||||||0.005||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 8 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.005
71035557|NCT05133180|141579922|SUPERIORITY|||||||0.116||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 12 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.116
71096778|NCT00927186|141702677|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
71096779|NCT00927186|141702677|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.003
71096780|NCT00927186|141702677|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.003
70980750|NCT04321343|141469183|SUPERIORITY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.232||0.0424|TWO_SIDED|95.0|-0.9426|0.017|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.0170|-0.9426|0.0424
70980751|NCT04321343|141469184|SUPERIORITY||Odds Ratio (OR)|3.31||||0.1084|TWO_SIDED|95.0|0.775|14.152|||Cochran-Mantel-Haenszel|||||14.152|0.775|0.1084
70980752|NCT04321343|141469184|SUPERIORITY||Odds Ratio (OR)|4.11||||0.0562|TWO_SIDED|95.0|0.959|17.594|||Cochran-Mantel-Haenszel|||||17.594|0.959|0.0562
70980753|NCT04321343|141469184|SUPERIORITY||Odds Ratio (OR)|1.87||||0.3333|TWO_SIDED|95.0|0.501|6.948|||Cochran-Mantel-Haenszel|||||6.948|0.501|0.3333
70980754|NCT04321343|141469185|SUPERIORITY||Odds Ratio (OR)|1.21||||0.7677|TWO_SIDED|95.0|0.345|4.23|||Cochran-Mantel-Haenszel|||||4.230|0.345|0.7677
70980755|NCT04321343|141469185|SUPERIORITY||Odds Ratio (OR)|1.62||||0.4828|TWO_SIDED|95.0|0.434|6.012|||Cochran-Mantel-Haenszel|||||6.012|0.434|0.4828
70980756|NCT04321343|141469185|SUPERIORITY||Odds Ratio (OR)|1.97||||0.2711|TWO_SIDED|95.0|0.598|6.486|||Cochran-Mantel-Haenszel|||||6.486|0.598|0.2711
70980757|NCT04321343|141469186|SUPERIORITY||Odds Ratio (OR)|1.44||||0.5981|TWO_SIDED|95.0|0.376|5.547|||Cochran-Mantel-Haenszel|||||5.547|0.376|0.5981
71096781|NCT00927186|141702678|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
70980758|NCT04321343|141469186|SUPERIORITY||Odds Ratio (OR)|1.42||||0.6228|TWO_SIDED|95.0|0.363|5.572|||Cochran-Mantel-Haenszel|||||5.572|0.363|0.6228
71096782|NCT00927186|141702678|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
71096783|NCT00927186|141702679|SUPERIORITY_OR_OTHER|||||||0.906||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.906
71096784|NCT00927186|141702679|SUPERIORITY_OR_OTHER|||||||0.159||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.159
71096785|NCT00927186|141702680|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.049
70980759|NCT04321343|141469186|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8799|TWO_SIDED|95.0|0.245|3.323|||Cochran-Mantel-Haenszel|||||3.323|0.245|0.8799
70980760|NCT04321343|141469187|SUPERIORITY||Odds Ratio (OR)|3.28||||0.1474|TWO_SIDED|95.0|0.625|17.208|||Cochran-Mantel-Haenszel|||||17.208|0.625|0.1474
70980761|NCT04321343|141469187|SUPERIORITY||Odds Ratio (OR)|2.65||||0.262|TWO_SIDED|95.0|0.481|14.631|||Cochran-Mantel-Haenszel|||||14.631|0.481|0.2620
70980762|NCT04321343|141469187|SUPERIORITY||Odds Ratio (OR)|0.7||||0.6935|TWO_SIDED|95.0|0.117|4.133|||Cochran-Mantel-Haenszel|||||4.133|0.117|0.6935
70980763|NCT04321343|141469188|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.6384|TWO_SIDED|95.0|-0.35|0.215|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.215|-0.350|0.6384
70980764|NCT04321343|141469188|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.14||0.0549|TWO_SIDED|95.0|-0.547|0.006|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.006|-0.547|0.0549
70980765|NCT04321343|141469188|SUPERIORITY||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.14||0.003|TWO_SIDED|95.0|-0.683|-0.142|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-0.142|-0.683|0.0030
70980766|NCT04321343|141469189|SUPERIORITY||Mean Difference (Final Values)|-0.051|STANDARD_ERROR_OF_MEAN|0.389||0.8961|TWO_SIDED|95.0|-0.8165|0.7149|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.7149|-0.8165|0.8961
70980767|NCT04321343|141469189|SUPERIORITY||Mean Difference (Final Values)|0.163|STANDARD_ERROR_OF_MEAN|0.384||0.671|TWO_SIDED|95.0|-0.5935|0.9204|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.9204|-0.5935|0.6710
70980768|NCT04321343|141469189|SUPERIORITY||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.364||0.9846|TWO_SIDED|95.0|-0.7092|0.7233|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.7233|-0.7092|0.9846
70980769|NCT04321343|141469190|SUPERIORITY||Mean Difference (Final Values)|-84.93|STANDARD_ERROR_OF_MEAN|36.75||0.0216|TWO_SIDED|95.0|-157.306|-12.558|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-12.558|-157.306|0.0216
70980770|NCT04321343|141469190|SUPERIORITY||Mean Difference (Final Values)|-46.61|STANDARD_ERROR_OF_MEAN|35.72||0.1931|TWO_SIDED|95.0|-116.957|23.738|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||23.738|-116.957|0.1931
71096786|NCT00927186|141702680|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
71096787|NCT00927186|141702680|SUPERIORITY_OR_OTHER|||||||0.151||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.151
70980771|NCT04321343|141469190|SUPERIORITY||Mean Difference (Final Values)|-63.4|STANDARD_ERROR_OF_MEAN|33.31||0.0581|TWO_SIDED|95.0|-129.002|2.194|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||2.194|-129.002|0.0581
70980772|NCT04321343|141469191|SUPERIORITY||Mean Difference (Final Values)|-0.256|STANDARD_ERROR_OF_MEAN|0.153||0.0958|TWO_SIDED|95.0|-0.5577|0.0456|||Mixed Models Analysis|Mixed Models Analysis|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.0456|-0.5577|0.0958
70980773|NCT04321343|141469191|SUPERIORITY||Mean Difference (Final Values)|-0.273|STANDARD_ERROR_OF_MEAN|0.148||0.0659|TWO_SIDED|95.0|-0.5648|0.0181|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.0181|-0.5648|0.0659
70980774|NCT04321343|141469191|SUPERIORITY||Mean Difference (Final Values)|-0.301|STANDARD_ERROR_OF_MEAN|0.138||0.0297|TWO_SIDED|95.0|-0.5728|-0.03|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-0.0300|-0.5728|0.0297
70980775|NCT04321343|141469192|SUPERIORITY||Mean Difference (Final Values)|-0.197|STANDARD_ERROR_OF_MEAN|0.175||0.2606|TWO_SIDED|95.0|-0.5423|0.1476|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.1476|-0.5423|0.2606
70980776|NCT04321343|141469192|SUPERIORITY||Mean Difference (Final Values)|-0.234|STANDARD_ERROR_OF_MEAN|0.17||0.1709|TWO_SIDED|95.0|-0.569|0.1016|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.1016|-0.5690|0.1709
70980777|NCT04321343|141469192|SUPERIORITY||Mean Difference (Final Values)|-0.321|STANDARD_ERROR_OF_MEAN|0.155||0.04|TWO_SIDED|95.0|-0.6274|-0.0148|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-0.0148|-0.6274|0.0400
70980778|NCT04321343|141469193|SUPERIORITY||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.012||0.3955|TWO_SIDED|95.0|-0.0139|0.0351|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.0351|-0.0139|0.3955
70980779|NCT04321343|141469193|SUPERIORITY||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.012||0.3081|TWO_SIDED|95.0|-0.0115|0.0362|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.0362|-0.0115|0.3081
71096788|NCT00927186|141702680|SUPERIORITY_OR_OTHER|||||||0.196||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.196
71035558|NCT05133180|141579922|SUPERIORITY|||||||0.864||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 16 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.864
71035559|NCT05133180|141579923|SUPERIORITY|||||||0.011||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 8 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.011
71035560|NCT05133180|141579923|SUPERIORITY|||||||0.316||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 12 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.316
70980780|NCT04321343|141469193|SUPERIORITY||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.011||0.1374|TWO_SIDED|95.0|-0.0053|0.0383|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.0383|-0.0053|0.1374
70980781|NCT04321343|141469194|SUPERIORITY||Mean Difference (Final Values)|-48.94|STANDARD_ERROR_OF_MEAN|20.86||0.0199|TWO_SIDED|95.0|-90.073|-7.817|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-7.817|-90.073|0.0199
70980782|NCT04321343|141469194|SUPERIORITY||Mean Difference (Final Values)|-29.77|STANDARD_ERROR_OF_MEAN|18.66||0.112|TWO_SIDED|95.0|-66.558|7.009|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||7.009|-66.558|0.1120
70980783|NCT04321343|141469194|SUPERIORITY||Mean Difference (Final Values)|-54.64|STANDARD_ERROR_OF_MEAN|17.9||0.0026|TWO_SIDED|95.0|-89.935|-19.34|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-19.340|-89.935|0.0026
70980784|NCT04321343|141469195|SUPERIORITY||Mean Difference (Final Values)|1.674|STANDARD_ERROR_OF_MEAN|0.896||0.0639|TWO_SIDED|95.0|-0.098|3.447|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||3.4470|-0.0980|0.0639
70980785|NCT04321343|141469195|SUPERIORITY||Mean Difference (Final Values)|2.831|STANDARD_ERROR_OF_MEAN|0.867||0.0014|TWO_SIDED|95.0|1.1149|4.5464|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||4.5464|1.1149|0.0014
70980786|NCT04321343|141469195|SUPERIORITY||Mean Difference (Final Values)|4.876|STANDARD_ERROR_OF_MEAN|0.848|<|0.0001|TWO_SIDED|95.0|3.1982|6.5543|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||6.5543|3.1982|<0.0001
71035561|NCT05133180|141579923|SUPERIORITY|||||||0.685||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 16 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.685
71035562|NCT05133180|141579924|SUPERIORITY|||||||0.016||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 8 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.016
70980787|NCT04321343|141469196|SUPERIORITY||Mean Difference (Final Values)|1.183|STANDARD_ERROR_OF_MEAN|0.909||0.1944|TWO_SIDED|95.0|-0.608|2.9748|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||2.9748|-0.6080|0.1944
70980788|NCT04321343|141469196|SUPERIORITY||Mean Difference (Final Values)|2.459|STANDARD_ERROR_OF_MEAN|0.879||0.0056|TWO_SIDED|95.0|0.7268|4.1907|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||4.1907|0.7268|0.0056
70980789|NCT04321343|141469196|SUPERIORITY||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|0.858||0.4288|TWO_SIDED|95.0|-1.0111|2.372|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||2.3720|-1.0111|0.4288
71035563|NCT05133180|141579924|SUPERIORITY|||||||0.16||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants|Wilcoxon (Mann-Whitney)|||Herein Week 12 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.160
71096789|NCT00927186|141702681|SUPERIORITY_OR_OTHER|||||||0.502||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.502
71096790|NCT00927186|141702681|SUPERIORITY_OR_OTHER|||||||0.597||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.597
71096791|NCT00927186|141702682|SUPERIORITY_OR_OTHER|||||||0.077||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.077
71096792|NCT00927186|141702682|SUPERIORITY_OR_OTHER|||||||0.358||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.358
71096793|NCT00927186|141702683|SUPERIORITY_OR_OTHER|||||||0.647||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.647
71096794|NCT00927186|141702683|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.120
70980790|NCT04321343|141469197|SUPERIORITY||Mean Difference (Final Values)|-1.251|STANDARD_ERROR_OF_MEAN|1.093||0.2564|TWO_SIDED|95.0|-3.4307|0.9295|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.9295|-3.4307|0.2564
70980791|NCT04321343|141469197|SUPERIORITY||Mean Difference (Final Values)|-1.598|STANDARD_ERROR_OF_MEAN|1.021||0.1222|TWO_SIDED|95.0|-3.6348|0.4392|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.4392|-3.6348|0.1222
70980792|NCT04321343|141469197|SUPERIORITY||Mean Difference (Final Values)|-2.22|STANDARD_ERROR_OF_MEAN|0.936||0.0206|TWO_SIDED|95.0|-4.088|-0.351|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||-0.3510|-4.0880|0.0206
70980793|NCT04321343|141469198|SUPERIORITY||Odds Ratio (OR)|1.51||||0.5221|TWO_SIDED|95.0|0.436|5.201|||Cochran-Mantel-Haenszel|||||5.201|0.436|0.5221
70980794|NCT04321343|141469198|SUPERIORITY||Odds Ratio (OR)|1.62||||0.4828|TWO_SIDED|95.0|0.434|6.012|||Cochran-Mantel-Haenszel|||||6.012|0.434|0.4828
70980795|NCT04321343|141469198|SUPERIORITY||Odds Ratio (OR)|2.87||||0.0914|TWO_SIDED|95.0|0.853|9.636|||Cochran-Mantel-Haenszel|||||9.636|0.853|0.0914
71096795|NCT00927186|141702683|SUPERIORITY_OR_OTHER|||||||0.695||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.695
71096796|NCT00927186|141702683|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||1.00
71096797|NCT00927186|141702684|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
70980796|NCT04321343|141469199|SUPERIORITY||Odds Ratio (OR)|2.71||||0.1854|TWO_SIDED|95.0|0.628|11.679|||Cochran-Mantel-Haenszel|||||11.679|0.628|0.1854
70980797|NCT04321343|141469199|SUPERIORITY||Odds Ratio (OR)|4.11||||0.0562|TWO_SIDED|95.0|0.959|17.594|||Cochran-Mantel-Haenszel|||||17.594|0.959|0.0562
70980798|NCT04321343|141469199|SUPERIORITY||Odds Ratio (OR)|1.53||||0.5223|TWO_SIDED|95.0|0.398|5.88|||Cochran-Mantel-Haenszel|||||5.880|0.398|0.5223
70980799|NCT04321343|141469200|SUPERIORITY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.891||0.7532|TWO_SIDED|95.0|-1.4749|2.0356|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||2.0356|-1.4749|0.7532
70980800|NCT04321343|141469200|SUPERIORITY||Mean Difference (Final Values)|1.985|STANDARD_ERROR_OF_MEAN|0.858||0.0216|TWO_SIDED|95.0|0.2946|3.6763|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||3.6763|0.2946|0.0216
70980801|NCT04321343|141469200|SUPERIORITY||Mean Difference (Final Values)|0.224|STANDARD_ERROR_OF_MEAN|0.838||0.7893|TWO_SIDED|95.0|-1.4283|1.8771|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||1.8771|-1.4283|0.7893
70980802|NCT04194944|141469201|SUPERIORITY||Hazard Ratio (HR)|0.465||||0.0002|TWO_SIDED|95.0|0.309|0.699|||Log Rank|||||0.699|0.309|0.0002
70980803|NCT04194944|141469202|SUPERIORITY||Hazard Ratio (HR)|0.482||||0.0001|TWO_SIDED|95.0|0.331|0.7|||Log Rank|||||0.700|0.331|0.0001
70980804|NCT04194944|141469203|SUPERIORITY||Odds Ratio (OR)|1.5||||0.3996|TWO_SIDED|95.0|0.7|3.4|||Cochran-Mantel-Haenszel|||||3.4|0.7|0.3996
70980805|NCT04194944|141469204|SUPERIORITY||Odds Ratio (OR)|1.7||||0.139|TWO_SIDED|95.0|0.9|3.6|||Cochran-Mantel-Haenszel|||||3.6|0.9|0.1390
70980806|NCT04194944|141469207|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0028|TWO_SIDED|95.0|1.4|5.1|||Cochran-Mantel-Haenszel|||||5.1|1.4|0.0028
70980807|NCT04194944|141469208|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0003|TWO_SIDED|95.0|1.6|5.2|||Cochran-Mantel-Haenszel|||||5.2|1.6|0.0003
70980808|NCT04194944|141469209|SUPERIORITY||Hazard Ratio (HR)|0.377||||0.0001|TWO_SIDED|95.0|0.224|0.633|||Log Rank|||||0.633|0.224|0.0001
70980809|NCT04194944|141469210|SUPERIORITY||Hazard Ratio (HR)|0.418||||0.0004|TWO_SIDED|95.0|0.256|0.684|||Log Rank|||||0.684|0.256|0.0004
70980810|NCT04194944|141469213|SUPERIORITY||Odds Ratio (OR)|3.2||||0.1809|TWO_SIDED|95.0|0.8|12.8|||Cochran-Mantel-Haenszel|||||12.8|0.8|0.1809
70980811|NCT04194944|141469214|SUPERIORITY||Odds Ratio (OR)|5.2||||0.0167|TWO_SIDED|95.0|1.4|19.6|||Cochran-Mantel-Haenszel|||||19.6|1.4|0.0167
70980812|NCT00045032|141469264|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
70980813|NCT00045032|141469264|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.44|0.67|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.67|0.44|
70980814|NCT00045032|141469265|SUPERIORITY_OR_OTHER|||||||0|||||||Log Rank|||||||0.000
70980815|NCT00045032|141469265|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43|||||TWO_SIDED|95.0|0.34|0.53|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.53|0.34|
70980816|NCT00045032|141469268|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
70980817|NCT00045032|141469268|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.67|0.86|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.86|0.67|
70980818|NCT00045032|141469268|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
70980819|NCT00045032|141469268|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.67|0.85|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.85|0.67|
70980820|NCT00045032|141469273|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.68|0.86|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.86|0.68|
70980821|NCT00045032|141469273|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.69|0.87|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.87|0.69|
70980822|NCT00045032|141469280|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.7962|TWO_SIDED|95.0|0.89|1.17|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.17|0.89|0.7962
70980823|NCT00045032|141469282|SUPERIORITY_OR_OTHER|||||||0.2379|||||||Log Rank|||||||0.2379
70980824|NCT00045032|141469282|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.47|1.21|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||1.21|0.47|
70980825|NCT00045032|141469283|SUPERIORITY_OR_OTHER|||||||0.003|||||||Log Rank|||||||0.003
70980826|NCT00045032|141469283|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.28|0.79|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.79|0.28|
70980827|NCT00045032|141469286|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Log Rank|||||||0.0005
70980828|NCT00045032|141469286|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.65|0.88|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.88|0.65|
71035564|NCT05133180|141579924|SUPERIORITY|||||||0.839||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 16 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.839
71035565|NCT05133180|141579925|SUPERIORITY|||||||0.0455|||||||Chi-squared|||||||0.0455
71035566|NCT05133180|141579926|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.06||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||Quality of life - Impact on daily activities - Week 8||||0.060
71035567|NCT05133180|141579926|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.079||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||Quality of life - Emotional impact due to Dry eye - Week 8||||0.079
71035568|NCT05133180|141579926|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.251||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants|t-test, 2 sided|||Quality of life - Impact on work due to Dry Eye - Week 8||||0.251
71035569|NCT05133180|141579926|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.203||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||Quality of life - Impact on daily activities - Week 16||||0.203
71035570|NCT05133180|141579926|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.114||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||Quality of life - Emotional impact due to Dry eye - Week 16||||0.114
71035571|NCT05133180|141579926|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.112||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||Quality of life - Impact on work due to Dry Eye - Week 16||||0.112
71035572|NCT05133180|141579927|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.002||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants|t-test, 2 sided|||Symptom bother module - Week 8||||0.002
71035573|NCT05133180|141579927|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.076||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants|t-test, 2 sided|||Symptom bother module - Week 16||||0.076
71035574|NCT05133180|141579928|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.16||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants|t-test, 2 sided|||IDEEL - Satisfaction with Treatment Effectiveness - Week 8||||0.160
71096798|NCT00927186|141702684|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
71096799|NCT00927186|141702685|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||1.00
70980829|NCT00045032|141469286|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Log Rank|||||||0.0001
70980830|NCT00045032|141469286|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.63|0.86|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.86|0.63|
70980831|NCT00045032|141469288|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.64|0.86|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.86|0.64|
70980832|NCT00045032|141469288|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.62|0.83|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.83|0.62|
71035575|NCT05133180|141579928|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.009||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||IDEEL - Treatment- Related Bother / Inconvenience - Week 8||||0.009
71035576|NCT05133180|141579928|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.076||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants|t-test, 2 sided|||IDEEL - Satisfaction with Treatment Effectiveness - Week 16||||0.076
71035577|NCT05133180|141579928|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.128||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||IDEEL - Treatment- Related Bother / Inconvenience - Week 16||||0.128
70980833|NCT00045032|141469290|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9156|TWO_SIDED|95.0|0.84|1.21|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.21|0.84|0.9156
70980834|NCT00045032|141469292|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
70980835|NCT00045032|141469292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.64|0.83|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.83|0.64|
70980836|NCT00045032|141469292|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
70980837|NCT00045032|141469292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.61|0.79|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.79|0.61|
70980838|NCT00045032|141469294|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.4755|TWO_SIDED|95.0|0.8|1.11|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.11|0.80|0.4755
71035578|NCT02284867|141579991|NON_INFERIORITY_OR_EQUIVALENCE|"Multivariable binary logistic regression was done to examine the relation between CD16+ NK and preterm labor as adjusted for other confounding factors the enter method was used to build the regression model.~A two-sided p-value \<0.05 was considered statistically significant."|Odds Ratio (OR)|65.01|STANDARD_ERROR_OF_MEAN|1.14|<|0.0002|TWO_SIDED|95.0|6.96|606.76||To our best of known , no previous human studies was analyzing this issue|Regression, Logistic|||"Categorical data were presented as number and percentage and differences were compared using the Pearson chi-squared test. Ordinal data were compared using the chi-squared test for trend~A two-sided p-value \<0.05 was considered statistically significant."||606.76|6.96|<0.0002
71096800|NCT00927186|141702685|SUPERIORITY_OR_OTHER|||||||0.198||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.198
71096801|NCT00927186|141702686|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.022
70980839|NCT00045032|141469296|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
70980840|NCT00045032|141469296|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.67|0.87|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.87|0.67|
70980841|NCT00045032|141469296|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
70980842|NCT00045032|141469296|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.65|0.85|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.85|0.65|
70980843|NCT00045032|141469298|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9626|TWO_SIDED|95.0|0.85|1.17|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.17|0.85|0.9626
70980844|NCT00045032|141469300|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
70980845|NCT00045032|141469300|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.64|0.83|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.83|0.64|
70980846|NCT00045032|141469300|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
70980847|NCT00045032|141469300|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.61|0.79|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.79|0.61|
70980848|NCT00045032|141469302|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.45|TWO_SIDED|95.0|0.8|1.1|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.10|0.80|0.4500
70980849|NCT00045032|141469304|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
70980850|NCT00045032|141469304|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.62|0.83|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.83|0.62|
70980851|NCT00045032|141469304|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
70980852|NCT00045032|141469304|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.59|0.79|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.79|0.59|
70980853|NCT00045032|141469306|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.6823|TWO_SIDED|95.0|0.8|1.15|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.15|0.80|0.6823
70980854|NCT00045032|141469308|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.7251|TWO_SIDED|95.0|0.84|1.13|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.13|0.84|0.7251
70980855|NCT05818124|141469336|OTHER||Difference in Least Squares Mean|-0.48||||0.783|TWO_SIDED|95.0|-3.97|3.0|||ANOVA|||||3.00|-3.97|0.783
70980856|NCT05818124|141469337|OTHER||Difference in Least Squares Mean|-2.21||||0.032|TWO_SIDED|95.0|-4.21|-0.21|||ANOVA|||||-0.21|-4.21|0.032
70980857|NCT05818124|141469338|OTHER||Difference in Least Squares Mean|0.2||||0.756|TWO_SIDED|95.0|-1.07|1.47|||ANOVA|||||1.47|-1.07|0.756
70980858|NCT05818124|141469339|OTHER|Clopper and Pearson exact binomial method|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-23.21|23.21||||||||23.21|-23.21|
70980859|NCT05818124|141469340|OTHER|Clopper and Pearson binomial method|Difference in percentage|-2.86|||||TWO_SIDED|95.0|-25.78|20.27||||||||20.27|-25.78|
70980860|NCT05818124|141469341|OTHER|Clopper and Pearson exact binomial method|Difference in Percentage|-8.57|||||TWO_SIDED|95.0|-30.26|13.38||||||||13.38|-30.26|
70980861|NCT05818124|141469342|OTHER|Clopper and Pearson binomial method|Difference in percentage|-5.71|||||TWO_SIDED|95.0|-25.18|13.97||||||||13.97|-25.18|
70980862|NCT05818124|141469343|OTHER|Clopper and Pearson binomial method|Difference in percentage|-5.71|||||TWO_SIDED|95.0|-25.18|13.97||||||||13.97|-25.18|
70980863|NCT05818124|141469344|OTHER|Clopper and Pearson binomial method|Difference in percentage|-8.57|||||TWO_SIDED|95.0|-27.63|10.5||||||||10.50|-27.63|
70980864|NCT05818124|141469347|OTHER||Hazard Ratio (HR)|0.82||||0.3102|TWO_SIDED|95.0|0.51|1.33|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||1.33|0.51|0.3102
70980865|NCT05818124|141469348|OTHER||Hazard Ratio (HR)|0.55||||0.0779|TWO_SIDED|95.0|0.27|1.14|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||1.14|0.27|0.0779
70980866|NCT05818124|141469351|OTHER||Difference in Least Squares Mean|-3.79||||0.045|TWO_SIDED|95.0|-7.47|-0.1|||ANOVA|||||-0.10|-7.47|0.045
70980867|NCT05818124|141469352|OTHER||Difference in Least Squares Mean|-2.56||||0.226|TWO_SIDED|95.0|-6.81|1.69|||ANOVA|||||1.69|-6.81|0.226
70980868|NCT05818124|141469353|OTHER||Difference in Least Squares Mean|-1.6||||0.09|TWO_SIDED|95.0|-3.47|0.27|||ANOVA|||||0.27|-3.47|0.090
70980869|NCT05818124|141469354|OTHER||Difference in Least Squares Mean|0.74||||0.609|TWO_SIDED|95.0|-2.19|3.66|||ANOVA|||||3.66|-2.19|0.609
70980870|NCT05818124|141469355|OTHER|Difference in Least Squares Mean|Difference in Least Squares Mean|0.34||||0.614|TWO_SIDED|95.0|-1.04|1.72|||ANOVA|||||1.72|-1.04|0.614
70980871|NCT05818124|141469356|OTHER||Difference in Least Squares Mean|0.37||||0.608|TWO_SIDED|95.0|-1.09|1.83|||ANOVA|||||1.83|-1.09|0.608
70980872|NCT05818124|141469357|OTHER||Difference in Least Squares Mean|0.43||||0.288|TWO_SIDED|95.0|-0.39|1.25|||ANOVA|||||1.25|-0.39|0.288
70980873|NCT05818124|141469358|OTHER||Difference in Least Squares Mean|0.09||||0.842|TWO_SIDED|95.0|-0.8|0.97|||ANOVA|||||0.97|-0.80|0.842
70980874|NCT05818124|141469361|OTHER||Hazard Ratio (HR)|0.31||||0.0042|TWO_SIDED|95.0|0.14|0.71|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||0.71|0.14|0.0042
70980875|NCT05818124|141469362|OTHER||Hazard Ratio (HR)|0.69||||0.329|TWO_SIDED|95.0|0.33|1.46|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||1.46|0.33|0.3290
70980876|NCT05818124|141469363|OTHER||Hazard Ratio (HR)|0.6||||0.1502|TWO_SIDED|95.0|0.27|1.34|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||1.34|0.27|0.1502
71035579|NCT01604941|141580001|SUPERIORITY_OR_OTHER_LEGACY|||||||0.296|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for 50 mg/kg/d dosing||||0.2960
71096802|NCT00927186|141702686|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
70980877|NCT05818124|141469364|OTHER||Hazard Ratio (HR)|1.32||||0.4865|TWO_SIDED|95.0|0.59|2.92|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||2.92|0.59|0.4865
70980878|NCT05818124|141469367|OTHER||Difference in Least Squares Mean|-4.79||||0.313|TWO_SIDED|95.0|-14.36|4.78|||ANOVA|||||4.78|-14.36|0.313
70980879|NCT05818124|141469368|OTHER||Difference in Least Squares Mean|-6.87||||0.138|TWO_SIDED|95.0|-16.11|2.36|||ANOVA|||||2.36|-16.11|0.138
70980880|NCT05818124|141469369|OTHER||Difference in LS mean|0.74||||0.706|TWO_SIDED|95.0|-3.26|4.74|||ANOVA|||||4.74|-3.26|0.706
70980881|NCT05818124|141469370|OTHER||Difference in LS mean|-1.58||||0.367|TWO_SIDED|95.0|-5.1|1.95|||ANOVA|||||1.95|-5.10|0.367
70980882|NCT05818124|141469376|OTHER||Difference in LS Mean|-4.14||||0.177|TWO_SIDED|95.0|-10.2|1.92|||ANOVA|||||1.92|-10.20|0.177
70980883|NCT05818124|141469377|OTHER||Difference in LS mean|-0.97||||0.395|TWO_SIDED|95.0|-3.24|1.29|||ANOVA|||||1.29|-3.24|0.395
70980884|NCT05818124|141469389|OTHER|Difference in least squares mean|Difference in least squares means|-0.94||||0.11|TWO_SIDED|95.0|-2.1|0.22|||ANOVA|||||0.22|-2.10|0.110
70980885|NCT05818124|141469390|OTHER||Difference in least squares mean|-1.6||||0.09|TWO_SIDED|95.0|-3.47|0.27|||ANOVA|||||0.27|-3.47|0.090
70980886|NCT01232946|141469450|SUPERIORITY|||||||0.65|||||||Kruskal-Wallis|||||||0.65
70980887|NCT01232946|141469451|SUPERIORITY|||||||0.065|||||||Kruskal-Wallis|||||||0.065
70980888|NCT01232946|141469452|SUPERIORITY|||||||0.8|||||||Kruskal-Wallis|||||||0.80
70980889|NCT02511522|141469453|SUPERIORITY|||||||0.004|||||||Cochran-Mantel-Haenszel|Adjusting for stratification factor (Hepatocellular carcinoma versus liver metastases)||||||0.004
70980890|NCT02511522|141469454|SUPERIORITY|||||||0.068|||||||Log Rank|Stratified Log Rank test adjusting for the stratification factor (Hepatocellular carcinoma versus liver metastases)||||||0.068
70980891|NCT02511522|141469455|SUPERIORITY|||||||0.45|||||||Cochran-Mantel-Haenszel|adjusting for the stratification factor (Hepatocellular carcinoma versus liver metastases)||||||0.45
70980892|NCT02511522|141469456|SUPERIORITY|||||||0.07|||||||Cochran-Mantel-Haenszel|adjusting for the stratification factor (Hepatocellular carcinoma versus liver metastases)||||||0.07
70980893|NCT02660580|141469457|EQUIVALENCE|MSB11022 was considered equivalent to EU-Humira if the 95% CI for the treatment difference was included in the equivalence interval \[-15%, 15%\]).|Least Square (LS) Mean difference|0.88|||||TWO_SIDED|95.0|-1.21|2.98||||||||2.98|-1.21|
70980894|NCT02660580|141469473|EQUIVALENCE|MSB11022 was considered equivalent to EU-Humira if the 95% stratified Newcombe Confidence Interval (CI) for the difference in percentage was included in the equivalence interval (-18, 18).|Percentage difference|-1.9|||||TWO_SIDED|95.0|-7.82|4.07||||||||4.07|-7.82|
70980895|NCT05224258|141469508|NON_INFERIORITY|The overall mean change in HbA1c from baseline to end of 3-month study period. The mean change will be estimated and compared to a threshold of -0.38% with a margin of 0.4%.|Mean difference from baseline to exit|-0.2|||<|0.001|TWO_SIDED|95.0|-0.4|-0.1|||t-test, 1 sided||This is one arm study, the differences of HbA1c from baseline to exit were summarized for this endpoint|||-0.1|-0.4|<0.001
70980896|NCT05224258|141469508|NON_INFERIORITY|The overall mean change in HbA1c from baseline to end of 3-month study period. The mean change will be estimated and compared to a threshold of -0.5% with a margin of 0.4%.|Mean difference from baseline to exit|-0.4|||<|0.001|TWO_SIDED|95.0|-0.5|-0.2|||Wilcoxon (Mann-Whitney)||This is one arm study, the differences of HbA1c from baseline to exit were summarized for this endpoint.|||-0.2|-0.5|<0.001
70980897|NCT05224258|141469509|NON_INFERIORITY|The mean % of time in range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) will be estimated and compared to a threshold of 65.3% with a margin of 7.5% and a significance level of 0.025 (one-sided).|Mean of Final Value|65.7|||<|0.001|TWO_SIDED|95.0|63.5|67.9|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||67.9|63.5|<0.001
70980898|NCT05224258|141469509|NON_INFERIORITY|The mean % of time in range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) will be estimated and compared to a threshold of 73.7% with a margin of 7.5% and a significance level of 0.025 (one-sided).|Mean of Final Value|77.1|||<|0.001|TWO_SIDED|95.0|75.4|78.9|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||78.9|75.4|<0.001
71035580|NCT01604941|141580001|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for all participants with BID dosing||||0.0400
71035581|NCT01604941|141580001|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6303|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 24 for all participants with BID dosing||||0.6303
71035582|NCT01604941|141580002|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0365|TWO_SIDED|||||P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for 50 mg/kg/d dosing||||0.0365
70980899|NCT05224258|141469510|NON_INFERIORITY|The mean % of time in hypoglycemia (\< 54 mg/dL \[3.0 mmol/L\]) will be estimated and compared to a threshold of 0.71% with a margin of 2% and a significance level of 0.025 (one-sided).|Mean of Final Value|0.3|||<|0.001|TWO_SIDED|95.0|0.3|0.4|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Hypoglycemia (\< 54 mg/dL \[3.0 mmol/L\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||0.4|0.3|<0.001
70980900|NCT05224258|141469510|NON_INFERIORITY|The mean % of time in hypoglycemia (\< 54 mg/dL \[3.0 mmol/L\]) will be estimated and compared to a threshold of 0.86% with a margin of 2% and a significance level of 0.025 (one-sided).|Mean of Final Value|0.3|||<|0.001|TWO_SIDED|95.0|0.2|0.4|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Hypoglycemia (\< 54 mg/dL \[3.0 mmol/L\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||0.4|0.2|<0.001
70980901|NCT05224258|141469511|SUPERIORITY|The mean % of time in range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) will be estimated and compared to a threshold of 65.3% and a significance level of 0.025 (one-sided).|Mean of Final Value|65.7||||0.208|TWO_SIDED|95.0|63.5|67.9|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||67.9|63.5|0.208
71035583|NCT01604941|141580002|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for all participants with BID dosing||||0.0019
71035584|NCT01604941|141580002|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1695|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 24 for all participants with BID dosing||||0.1695
71035585|NCT01604941|141580003|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0394|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for 50 mg/kg/d dosing||||0.0394
71035586|NCT01604941|141580003|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for all participants with BID dosing||||0.0004
71096803|NCT00927186|141702686|SUPERIORITY_OR_OTHER|||||||0.151||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.151
71096804|NCT00927186|141702686|SUPERIORITY_OR_OTHER|||||||0.139||95.0||||-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.139
71096805|NCT00927186|141702687|SUPERIORITY_OR_OTHER|||||||0.154||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.154
71096806|NCT00927186|141702687|SUPERIORITY_OR_OTHER|||||||0.052||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.052
71096807|NCT00927186|141702688|SUPERIORITY_OR_OTHER|||||||0.906||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.906
71096808|NCT00927186|141702688|SUPERIORITY_OR_OTHER|||||||0.159||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.159
70980902|NCT05224258|141469511|SUPERIORITY|The mean % of time in range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) will be estimated and compared to a threshold of 73.7% and a significance level of 0.025 (one-sided).|Mean of Final Value|77.1|||<|0.001|TWO_SIDED|95.0|75.4|78.9|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||78.9|75.4|<0.001
70980903|NCT00486902|141469512|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Fisher Exact|||Sample size was determined assuming an incidence of breakthrough pain of 75% and an absolute difference between groups of -20 to +15%. This rate of request for analgesia in the first 24 h was based on data from a parallel study utilizing the same multimodal postoperative pain regimen for cesarean delivery. Group sample sizes of 90 achieve 80% power to detect this difference using the two-sided Z test with pooled variance. The significance level of the test was targeted at 0.05.||||0.86
70980904|NCT00486902|141469513|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.02
70980905|NCT00486902|141469514|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.24
70980906|NCT00486902|141469515|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Fisher Exact|||||||0.87
70980907|NCT00486902|141469516|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Fisher Exact|||||||0.90
71035587|NCT01604941|141580003|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0332|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 24 for all participants with BID dosing||||0.0332
71035588|NCT01604941|141580004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3202|TWO_SIDED|||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for 50 mg/kg/d dosing||||0.3202
71035589|NCT01604941|141580004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4549|TWO_SIDED|||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for all participants with BID dosing||||0.4549
71035590|NCT01604941|141580004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3291|TWO_SIDED|||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 24 for all participants with BID dosing||||0.3291
71035591|NCT01604941|141580005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6703|TWO_SIDED|||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 8 for 50 mg/kg/d dosing||||0.6703
71035592|NCT01604941|141580005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2618|TWO_SIDED|||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 8 for all participants with BID dosing||||0.2618
71035593|NCT01604941|141580005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7679|TWO_SIDED|||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 16 for all participants with BID dosing||||0.7679
71035594|NCT01604941|141580006|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1683|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for 50 mg/kg/d dosing||||0.1683
71096809|NCT00927186|141702689|SUPERIORITY_OR_OTHER|||||||0.979||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.979
70980908|NCT00486902|141469517|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Fisher Exact|||||||0.24
70980909|NCT00486902|141469518|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
70980910|NCT00486902|141469519|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.6||||0.02|TWO_SIDED|95.0|-1.1|-0.09|||Wilcoxon (Mann-Whitney)|||||-0.09|-1.1|0.02
70980911|NCT00733902|141469531|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.3||0.015|TWO_SIDED|95.0|-1.32|-0.14|||ANCOVA|||Analysis of Covariance (ANCOVA) was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.14|-1.32|0.015
70980912|NCT00733902|141469531|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.3||0.005|TWO_SIDED|95.0|-1.43|-0.25|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.25|-1.43|0.005
70980913|NCT00733902|141469531|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.78|-0.61|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.61|-1.78|<0.001
70980914|NCT00733902|141469532|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.29||0.009|TWO_SIDED|95.0|-1.32|-0.19|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.19|-1.32|0.009
71096810|NCT00927186|141702689|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.002
71096811|NCT00927186|141702689|SUPERIORITY_OR_OTHER|||||||0.695||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.695
70980915|NCT00733902|141469532|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.54|-0.41|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.41|-1.54|<0.001
70980916|NCT00733902|141469532|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.8|-0.68|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.68|-1.80|<0.001
70980917|NCT00733902|141469533|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.52|-0.13|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.13|-0.52|0.001
70980918|NCT00733902|141469533|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.56|-0.17|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.17|-0.56|<0.001
70980919|NCT00733902|141469533|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.7|-0.31|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.31|-0.70|<0.001
70980920|NCT00733902|141469534|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.27||0.326|TWO_SIDED|95.0|-0.8|0.27|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.27|-0.80|0.326
70980921|NCT00733902|141469534|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.275|TWO_SIDED|95.0|-0.24|0.83|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.83|-0.24|0.275
70980922|NCT00733902|141469534|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.27||0.918|TWO_SIDED|95.0|-0.51|0.56|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.56|-0.51|0.918
70980923|NCT00733902|141469534|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.47|-0.4|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.40|-1.47|<0.001
70980924|NCT00733902|141469534|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.27||0.013|TWO_SIDED|95.0|-1.22|-0.15|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.15|-1.22|0.013
70980925|NCT00733902|141469534|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.57|-0.49|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.49|-1.57|<0.001
70980926|NCT00733902|141469534|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.27||0.003|TWO_SIDED|95.0|-1.36|-0.28|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.28|-1.36|0.003
70980927|NCT00733902|141469534|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.27||0.006|TWO_SIDED|95.0|-1.29|-0.21|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.21|-1.29|0.006
70980928|NCT00733902|141469534|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.87|-0.79|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.79|-1.87|<0.001
70980929|NCT00733902|141469534|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.68|-0.53|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.53|-1.68|<0.001
70980930|NCT00733902|141469534|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.29||0.002|TWO_SIDED|95.0|-1.48|-0.33|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.33|-1.48|0.002
70980931|NCT00733902|141469534|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.29|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.87|-0.72|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.72|-1.87|<0.001
71035595|NCT01604941|141580006|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0123|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for all participants with BID dosing||||0.0123
71035596|NCT01604941|141580006|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2334|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 24 for all participants with BID dosing||||0.2334
71035597|NCT03930732|141580012|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle primary and a few secondary endpoint analyses at a 2-sided significance level of 0.049. Testing was then performed sequentially in the order the endpoints are reported (till OM 9). The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.049 level.|Risk Difference (RD)|-0.324||||0.0005|TWO_SIDED|95.0|-0.508|-0.14|||Negative binomial model||Derived using delta method.|Derived using negative binomial model with the total number of the events occurring during the 52-week treatment period as the response variable, and treatment group, region (pooled country), inhaled corticosteroid (ICS) dose, smoking status at screening, baseline disease severity, and number of moderate or severe COPD exacerbation events within one year prior to the study as covariates, and log-transformed treatment duration as an offset variable.||-0.140|-0.508|0.0005
70980932|NCT00733902|141469534|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.31||0.027|TWO_SIDED|95.0|-1.28|-0.08|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.08|-1.28|0.027
70980933|NCT00733902|141469534|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.31||0.071|TWO_SIDED|95.0|-1.15|0.05|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.05|-1.15|0.071
70980934|NCT00733902|141469534|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-1.78|-0.58|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.58|-1.78|<0.001
70980935|NCT00733902|141469535|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.27||0.326|TWO_SIDED|95.0|-0.8|0.27|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.27|-0.80|0.326
70980936|NCT00733902|141469535|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.275|TWO_SIDED|95.0|-0.24|0.83|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.83|-0.24|0.275
71096812|NCT00927186|141702689|SUPERIORITY_OR_OTHER|||||||0.853||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.853
71096813|NCT00927186|141702690|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for sLS/BS.|Wilcoxon (Mann-Whitney)|||||||<0.001
71096814|NCT00927186|141702690|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for dLS/BS.|Wilcoxon (Mann-Whitney)|||||||<0.001
70980937|NCT00733902|141469535|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.27||0.918|TWO_SIDED|95.0|-0.51|0.56|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.56|-0.51|0.918
70980938|NCT00733902|141469535|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.27||0.002|TWO_SIDED|95.0|-1.39|-0.32|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.32|-1.39|0.002
70980939|NCT00733902|141469535|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.27||0.052|TWO_SIDED|95.0|-1.06|0.0|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.00|-1.06|0.052
70980940|NCT00733902|141469535|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.5|-0.44|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.44|-1.50|<0.001
70980941|NCT00733902|141469535|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.27||0.006|TWO_SIDED|95.0|-1.26|-0.21|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.21|-1.26|0.006
70980942|NCT00733902|141469535|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.27||0.004|TWO_SIDED|95.0|-1.28|-0.24|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.24|-1.28|0.004
70980943|NCT00733902|141469535|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.38|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.91|-0.86|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.86|-1.91|<0.001
70980944|NCT00733902|141469535|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.5|-0.43|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.43|-1.50|<0.001
71035598|NCT03930732|141580013|SUPERIORITY||Least Square (LS) Mean Difference|0.083|||<|0.0001|TWO_SIDED|95.0|0.042|0.125||Threshold for significance at 0.049 level.|MMRM model|||Derived from mixed-effect model with repeated measures (MMRM) model with the change from baseline in pre-BD FEV1 up to Week 12 as response variables, and treatment group, age, sex, height, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline pre-BD FEV1, and FEV1 baseline-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||0.125|0.042|<0.0001
71096815|NCT00927186|141702691|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value is for sLS/BS.|Wilcoxon (Mann-Whitney)|||||||0.006
71096816|NCT00927186|141702691|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value is for dLS/BS.|Wilcoxon (Mann-Whitney)|||||||0.001
71096817|NCT00927186|141702692|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for sLS/BS at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
71096818|NCT00927186|141702692|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for dLS/BS at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
71096819|NCT00927186|141702692|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value is for sLS/BS at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.004
70980945|NCT00733902|141469535|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.27||0.005|TWO_SIDED|95.0|-1.3|-0.23|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.23|-1.30|0.005
71035599|NCT03930732|141580014|SUPERIORITY||LS Mean Difference|0.083||||0.0003|TWO_SIDED|95.0|0.038|0.128||Threshold for significance at 0.049 level.|MMRM model|||Derived from MMRM model with the change from baseline in pre-BDFEV1 up to Week 52 as response variables, and treatment group, age, sex, height, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline pre-BD FEV1, and FEV1 baseline-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||0.128|0.038|0.0003
70980946|NCT00733902|141469535|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.22|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.75|-0.69|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.69|-1.75|<0.001
70980947|NCT00733902|141469535|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.28||0.061|TWO_SIDED|95.0|-1.07|0.02|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.02|-1.07|0.061
70980948|NCT00733902|141469535|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.28||0.021|TWO_SIDED|95.0|-1.2|-0.1|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.10|-1.20|0.021
70980949|NCT00733902|141469535|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.85|-0.76|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.76|-1.85|<0.001
70980950|NCT00733902|141469535|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.28||0.166|TWO_SIDED|95.0|-0.95|0.16|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.16|-0.95|0.166
71035600|NCT03930732|141580015|SUPERIORITY||LS Mean Difference|0.124||||0.0022|TWO_SIDED|95.0|0.045|0.203||Threshold for significance at 0.049 level.|MMRM model|||Derived from MMRM model with the change from baseline in pre-BD FEV1 up to Week 12 as response variables, and treatment group, age, sex, height, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline pre-BD FEV1, and FEV1 baseline-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||0.203|0.045|0.0022
70980951|NCT00733902|141469535|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.28||0.167|TWO_SIDED|95.0|-0.95|0.16|||ANOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.16|-0.95|0.167
70980952|NCT00733902|141469535|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.75|-0.64|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.64|-1.75|<0.001
70980953|NCT00733902|141469536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.27||0.044|TWO_SIDED|95.0|-1.07|-0.02|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.02|-1.07|0.044
70980954|NCT00733902|141469536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.27||0.875|TWO_SIDED|95.0|-0.57|0.48|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.48|-0.57|0.875
70980955|NCT00733902|141469536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.27||0.129|TWO_SIDED|95.0|-0.93|0.12|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.12|-0.93|0.129
70980956|NCT00733902|141469536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.51|-0.45|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.45|-1.51|<0.001
70980957|NCT00733902|141469536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.27||0.002|TWO_SIDED|95.0|-1.38|-0.32|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.32|-1.38|0.002
70980958|NCT00733902|141469536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.76|-0.7|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.70|-1.76|<0.001
70980959|NCT00733902|141469536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.27||0.002|TWO_SIDED|95.0|-1.35|-0.3|||ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.30|-1.35|0.002
70980960|NCT00733902|141469536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.27||0.001|TWO_SIDED|95.0|-1.39|-0.34|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.34|-1.39|0.001
70980961|NCT00733902|141469536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.94|-0.9|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.90|-1.94|<0.001
70980962|NCT00733902|141469536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.14|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.7|-0.58|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.58|-1.70|<0.001
70980963|NCT00733902|141469536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.57|-0.45|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.45|-1.57|<0.001
71096820|NCT00927186|141702692|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value is for dLS/BS at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.006
71035601|NCT03930732|141580016|SUPERIORITY||LS Mean Difference|0.127||||0.0034|TWO_SIDED|95.0|0.042|0.212||Threshold for significance at 0.049 level.|MMRM model|||Derived from MMRM model with the change from baseline in pre-BD FEV1 up to Week 52 as response variables, and treatment group, age, sex, height, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline pre-BD FEV1, and FEV1 baseline-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||0.212|0.042|0.0034
71035602|NCT03930732|141580017|SUPERIORITY||LS Mean Difference|-3.363||||0.0017|TWO_SIDED|95.0|-5.459|-1.266||Threshold for significance at 0.049 level.|MMRM model|||Derived from MMRM model with the change from baseline in SGRQ total score up to Week 52 as response variables, and treatment group, region (pooled country), ICS dose, smoking status at screening, treatment-by-visit interaction, baseline SGRQ total score, and SGRQ baseline-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-1.266|-5.459|0.0017
71035603|NCT03930732|141580018|SUPERIORITY||Odds Ratio (OR)|1.439||||0.0089|TWO_SIDED|95.0|1.096|1.89||Threshold for significance at 0.049 level.|Regression, Logistic|||Derived from logistic regression model which includes treatment group, region (pooled country), ICS dose, smoking status at screening, and baseline SGRQ total score as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||1.890|1.096|0.0089
71035604|NCT03930732|141580019|SUPERIORITY||LS Mean Difference|-1.137||||0.0012|TWO_SIDED|95.0|-1.823|-0.45||Threshold for significance at 0.049 level.|MMRM model|||Derived from MMRM model with the change from baseline in E-RS: COPD RS-Total Score to Week 52 as response variables, and treatment group, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline E-RS: COPD RS-Total Score, and baseline E-RS: COPD RS-Total Score-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-0.450|-1.823|0.0012
70980964|NCT00733902|141469536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.35|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.91|-0.79|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.79|-1.91|<0.001
71035605|NCT03930732|141580020|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|Risk Difference (RD)|-0.418||||0.0052|TWO_SIDED|95.0|-0.728|-0.109||Threshold for significance at 0.049 level.|Negative binomial model||Derived using delta method.|Derived using negative binomial model with the total number of the events occurring during the 52-week treatment period as the response variable, and treatment group, region (pooled country), ICS dose, smoking status at screening, baseline disease severity, and number of moderate or severe COPD exacerbation events within one year prior to the study as covariates, and log-transformed treatment duration as an offset variable.||-0.109|-0.728|0.0052
71035606|NCT04708028|141580037|SUPERIORITY|||||||0.379|||||||Wilcoxon (Mann-Whitney)|||Baseline||||0.379
71096821|NCT00927186|141702693|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||"P-value is a comparison of No Label vs. Single, Double, Single and Double Label."|Fisher Exact|||||||<0.001
71096822|NCT00927186|141702694|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||"P-value is a comparison of No Label vs. Single, Double, Single and Double Label."|Fisher Exact|||||||0.033
71096823|NCT00927186|141702695|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||"P-value is a comparison of No Label vs. Single, Double, Single and Double Label at 6 months."|Fisher Exact|||||||<0.001
71096824|NCT00927186|141702695|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||"P-value is a comparison of No Label vs. Single, Double, Single and Double Label at 24 months."|Fisher Exact|||||||0.009
71096825|NCT00927186|141702696|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
71096826|NCT00927186|141702697|SUPERIORITY_OR_OTHER|||||||0.906||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.906
71096827|NCT00927186|141702698|SUPERIORITY_OR_OTHER|||||||0.536||95.0||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)|||||||0.536
71096828|NCT00927186|141702698|SUPERIORITY_OR_OTHER|||||||0.896||95.0||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)|||||||0.896
70980965|NCT00733902|141469536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.29||0.021|TWO_SIDED|95.0|-1.26|-0.1|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.10|-1.26|0.021
70980966|NCT00733902|141469536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.29||0.029|TWO_SIDED|95.0|-1.22|-0.07|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.07|-1.22|0.029
71035607|NCT04708028|141580037|SUPERIORITY|||||||0.646|||||||Wilcoxon (Mann-Whitney)|||8 minutes Post intervention (Dog exposure or no dog exposure)||||0.646
71035608|NCT04708028|141580037|SUPERIORITY|||||||0.219|||||||Wilcoxon (Mann-Whitney)|||8 minutes after starting dental procedure||||0.219
71035609|NCT04708028|141580037|SUPERIORITY|||||||0.223|||||||Wilcoxon (Mann-Whitney)|||8 minutes after completion of dental procedure||||0.223
71035610|NCT04708028|141580038|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Baseline||||0.410
71035611|NCT04708028|141580038|SUPERIORITY|||||||0.127|||||||Wilcoxon (Mann-Whitney)|||8 minutes Post intervention (Dog exposure or no dog exposure)||||0.127
71035612|NCT04708028|141580038|SUPERIORITY|||||||0.268|||||||Wilcoxon (Mann-Whitney)|||8 minutes after starting dental procedure||||0.268
71035613|NCT04708028|141580038|SUPERIORITY|||||||0.353|||||||Wilcoxon (Mann-Whitney)|||8 minutes after completion of dental procedure||||0.353
71035614|NCT02699463|141580039|SUPERIORITY||||||<|0.01||||||The calculated p-value was \<0.01|ANCOVA|||||||<0.01
71035615|NCT01108445|141580040|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.406||||0.157|TWO_SIDED||||||Log Rank|||||||0.157
71096829|NCT00927186|141702699|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71096830|NCT00927186|141702700|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
71096831|NCT00927186|141702701|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71096832|NCT00927186|141702702|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.008
71096833|NCT00927186|141702703|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
71035616|NCT01108445|141580042|SUPERIORITY_OR_OTHER||Median PFS|5.6|||||TWO_SIDED||||||||The 95% CI for the HC was (4,6). If the median PFS for RAD001 is within the 95% CI for the HC, it is determined that there is not enough statistical evidence to say that the median PFS is different than the HC.|A comparison of the median PFS for RAD001 arm was compared to the 95% confidence interval(CI) of the median PFS of the historical control (HC). The null hypothesis was that there is no difference in the median PFS between the treatment arms and the historical control. If the median PFS is outside the 95%CI for the HC,it is determined there is statistical evidence that median PFS is different from the HC.||||
71035617|NCT01108445|141580042|SUPERIORITY_OR_OTHER||Median PFS|8.3|||||TWO_SIDED||||||||95% CI for HC was(4,6). If the median PFS for Sunitinib is within the 95% CI for the HC,it is determined that there is not enough statistical evidence to say that the median PFS is different than the HC.|A comparison of the median PFS for Sunitinib arm was compared to the 95% confidence interval(CI) of the median PFS of the historical control (HC). The null hypothesis was that there is no difference in the median PFS between the treatment arms and the historical control. If the median PFS is outside the 95%CI for the HC,it is determined there is statistical evidence that median PFS is different from the HC.||||
71035618|NCT01108445|141580044|SUPERIORITY_OR_OTHER|||||||0.589|TWO_SIDED||||||Chi-squared|||||||0.589
71035619|NCT01108445|141580045|SUPERIORITY_OR_OTHER|||||||0.066|TWO_SIDED||||||Chi-squared|||||||0.066
71035620|NCT04188392|141580061|OTHER|Rate of subjects enrolled per month of recruitment; based on 6 subjects enrolled over 5.8 months of recruitment.|Rate (per month)|1.03|||||TWO_SIDED|95.0|0.38|2.25|||||Based on 6 subjects enrolled over 5.8 months of recruitment|Recruitment goal of 6 subjects total.||2.25|0.38|
71035621|NCT04188392|141580062|OTHER|Total participants = 6; completed protocol: yes = 6, no = 0|Point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate = 100% (95% C.I. 54%,100%)|Binary outcome (completed protocol yes vs. no); goal of 75% of subjects completing protocol|Point estimate of completion rate and 95% confidence interval|1|0.54|
71035622|NCT04188392|141580063|OTHER|paired t-test|Mean of the differences|21.7||||0.2873|TWO_SIDED|95.0|-27.4|70.8||A priori significance threshold of p\<0.05|t-test, 2 sided|t=1.2263, df=4||alternative hypothesis: true difference in means is not equal to 0||70.8|-27.4|0.2873
71035623|NCT04188392|141580064|OTHER|Total participants = 6; discontinued due to adverse effects: yes = 0, no =6|Point estimate, 95% confidence interval|0.0|||||TWO_SIDED|95.0|0.0|0.46|||||Discontinuation rates due to adverse effects: Point estimate 0% (95% C.I. 0%, 45.9%)|Binary outcome: Discontinued due to adverse effects yes vs. no||0.46|0|
71035624|NCT04188392|141580065|OTHER|Total participants = 6; completed sleep study 1: yes = 6, no=0|point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate of completion rate for sleep study 1 = 100% (95% C.I. 54%, 100%)|Binary outcome: Completed sleep study 1 yes vs. no||1|0.54|
71035625|NCT04188392|141580065|OTHER|Total participants = 6; completed sleep study 2: yes = 6, no=0|point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate of completion rate for sleep study 2 = 100% (95% C.I. 54%, 100%)|Binary outcome: completed sleep study 2 yes vs. no||1|0.54|
71035626|NCT04188392|141580065|OTHER|Total participants = 6; completed sleep study 3: yes = 5, no=1|point estimate|0.83|||||TWO_SIDED|95.0|0.36|0.996|||||Point estimate of completion rate for sleep study 3 = 83.3% (95% C.I. 36%, 99.6%)|Binary outcome: completed sleep study 3 yes vs. no||0.996|0.36|
71035627|NCT04188392|141580065|OTHER|Total participants = 6; at least 4 days of actigraphy data: yes = 6, no=0|point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate of completion rate for at least 4 days of actigraphy pre-treatment = 100% (95% C.I. 54%, 100%).|Binary outcome: at least 4 days of actigraphy data pre-treatment yes vs. no||1|0.54|
71035628|NCT04188392|141580065|OTHER|Total participants = 6; at least 4 days of actigraphy post-treatment: yes = 6, no =0|point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate of at least 4 days of actigraphy post-treatment = 100% (95% C.I. 54%, 100%)|Binary outcome: at least 4 days of actigraphy post-treatment yes vs. no||1|0.54|
71035629|NCT04188392|141580065|OTHER|Total participants = 6; at least 4 days of sleep diary pre-treatment: yes = 6, no = 0|point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate of at least 4 days of sleep diary pre-treatment = 100% (95% C.I. 54%, 100%)|Binary outcome: at least 4 days of sleep diary pre-treatment yes vs. no||1|0.54|
71035630|NCT04188392|141580065|OTHER|Total participants = 6; at least 4 days of sleep diary post-treatment: yes = 6, no = 0|point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate of at least 4 days of sleep diary post-treatment = 100% (95% C.I. 54%, 100%)|Binary outcome: at least 4 days of sleep diary post-treatment yes vs. no||1|0.54|
71035631|NCT01447511|141580066|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||The null hypothesis is that the mean S-warfarin clearance among the five CYP2C9 genotypes under control conditions is the same.||||<0.0001
71035632|NCT01447511|141580066|SUPERIORITY_OR_OTHER||||||=|0.0001|||||||ANOVA|||The null hypothesis is that the mean S-warfarin clearance among the five CYP2C9 genotypes under fluconazole conditions is the same.||||=0.0001
71035633|NCT01447511|141580066|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||The null hypothesis is that the mean S-warfarin clearance among the five CYP2C9 genotypes under rifampin conditions is the same.||||<0.0001
71035634|NCT01447511|141580066|SUPERIORITY_OR_OTHER||||||=|0.3058|||||||ANOVA|||The null hypothesis is that the mean R-warfarin clearance among the five CYP2C9 genotypes under control conditions is the same.||||=0.3058
71096834|NCT00927186|141702703|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)|||||||0.006
71035635|NCT01447511|141580066|SUPERIORITY_OR_OTHER||||||=|0.3278|||||||ANOVA|||The null hypothesis is that the mean R-warfarin clearance among the five CYP2C9 genotypes under fluconazole conditions is the same.||||=0.3278
71035636|NCT01447511|141580066|SUPERIORITY_OR_OTHER||||||=|0.6155|||||||ANOVA|||The null hypothesis is that the mean R-warfarin clearance among the five CYP2C9 genotypes under rifampin conditions is the same.||||=0.6155
71035637|NCT01125163|141580084|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|95.0||||All infants were analyzed according to their assigned groups.|Wilcoxon (Mann-Whitney)|||A non-parametric rank sum analysis was performed as follows so that infants who died before 36 wks and infants who were transfused could be included in an intention-to-treat analysis. Infants were ranked by death (lowest rank) then by number of transfusions (next lowest ranks). For infants who survived and were not transfused, the 36 wks PMA Hct was used as the primary outcome.||||0.59
71096835|NCT00927186|141702704|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71096836|NCT00927186|141702705|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.079
71096837|NCT00927186|141702706|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
70980967|NCT00733902|141469536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.78|-0.62|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.62|-1.78|<0.001
71035638|NCT01125163|141580085|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||A non-parametric rank sum analysis was performed as follows so that infants who died before 36 wks and infants who were transfused could be included in an intention-to-treat analysis. Infants were ranked by death (lowest rank) then by number of transfusions (next lowest ranks). For infants who survived and were not transfused, the 36 wks PMA Hct was used as the primary outcome.||||0.64
71035639|NCT01030133|141580106|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|0.75||||||0.05
71035640|NCT04517604|141580116|SUPERIORITY||Mean Difference (Final Values)|-5.02|STANDARD_DEVIATION|4.984||0.343|TWO_SIDED|95.0|-16.52|6.47||no adjustment for multiple comparisons as was a pilot|Mixed Models Analysis|||||6.47|-16.52|.343
71035641|NCT04517604|141580117|SUPERIORITY|This was a pilot study funded under a pilot funding mechanism which specifically did not require a power analysis.|Mean Difference (Final Values)|-1.7|STANDARD_DEVIATION|0.42||0.0026|TWO_SIDED|95.0|-2.63|-0.77||no test for multiple comparisons as this was a pilot study|Mixed Models Analysis|||This was an open-label, single group study using a within subject design. We compared pre-treatment values to post-treatment values.||-.77|-2.63|.0026
71096838|NCT00927186|141702706|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)|||||||0.039
70980968|NCT00733902|141469537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.27||0.044|TWO_SIDED|95.0|-1.07|-0.02|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.02|-1.07|0.044
70980969|NCT00733902|141469537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.27||0.875|TWO_SIDED|95.0|-0.57|0.48|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.48|-0.57|0.875
71035642|NCT05511935|141580121|SUPERIORITY||Mean Difference (Final Values)|1.75|STANDARD_ERROR_OF_MEAN|3.69||0.64|TWO_SIDED|95.0|-5.57|9.06|||t-test, 2 sided|||||9.06|-5.57|0.64
71035643|NCT05511935|141580122|SUPERIORITY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|1.81||0.47|TWO_SIDED|95.0|-2.28|4.89|||t-test, 2 sided|||||4.89|-2.28|0.47
71035644|NCT05511935|141580123|SUPERIORITY||Mean Difference (Final Values)|-2.33|STANDARD_ERROR_OF_MEAN|4.25||0.59|TWO_SIDED|95.0|-10.77|6.11|||t-test, 2 sided|||||6.11|-10.77|0.59
71096839|NCT00927186|141702707|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.014
71096840|NCT00927186|141702708|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.079
71096841|NCT00927186|141702709|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)|||||||0.027
71035645|NCT05511935|141580124|SUPERIORITY||Mean Difference (Final Values)|-1.61|STANDARD_ERROR_OF_MEAN|5.53||0.77|TWO_SIDED|95.0|-12.61|9.38|||t-test, 2 sided|||||9.38|-12.61|0.77
71035646|NCT05511935|141580125|SUPERIORITY||Mean Difference (Final Values)|-12.21|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-17.95|-6.47|||t-test, 2 sided|||||-6.47|-17.95|<0.001
71035647|NCT05511935|141580126|SUPERIORITY||Mean Difference (Final Values)|1.62|STANDARD_ERROR_OF_MEAN|1.87||0.39|TWO_SIDED|95.0|-2.1|5.34|||t-test, 2 sided|||||5.34|-2.10|0.39
71035648|NCT05511935|141580127|SUPERIORITY||Mean Difference (Final Values)|-8.88|STANDARD_ERROR_OF_MEAN|2.84|<|0.01|TWO_SIDED|95.0|-14.52|-3.24|||t-test, 2 sided|||||-3.24|-14.52|<0.01
71035649|NCT05511935|141580128|SUPERIORITY||Mean Difference (Final Values)|-2.84|STANDARD_ERROR_OF_MEAN|4.06||0.49|TWO_SIDED|95.0|-10.9|5.23|||t-test, 2 sided|||||5.23|-10.90|0.49
70980970|NCT00733902|141469537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.27||0.129|TWO_SIDED|95.0|-0.93|0.12|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.12|-0.93|0.129
70980971|NCT00733902|141469537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.46|-0.41|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.41|-1.46|<0.001
70980972|NCT00733902|141469537|SUPERIORITY_OR_OTHER_LEGACY||L Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.27||0.004|TWO_SIDED|95.0|-1.28|-0.24|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.24|-1.28|0.004
70980973|NCT00733902|141469537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.71|-0.67|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.67|-1.71|<0.001
70980974|NCT00733902|141469537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.26||0.002|TWO_SIDED|95.0|-1.33|-0.3|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.30|-1.33|0.002
70980975|NCT00733902|141469537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.46|-0.43|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.43|-1.46|<0.001
71035650|NCT05511935|141580130|SUPERIORITY||Slope|7.71|STANDARD_ERROR_OF_MEAN|5.28||0.15|TWO_SIDED|95.0|-2.92|18.35|||Regression, Linear|||||18.35|-2.92|0.15
71035651|NCT05511935|141580131|SUPERIORITY||Slope|0.43|STANDARD_ERROR_OF_MEAN|4.19||0.92|TWO_SIDED|95.0|-8.13|8.99|||Regression, Linear|||||8.99|-8.13|0.92
71035652|NCT05511935|141580132|SUPERIORITY||Slope|7.66|STANDARD_ERROR_OF_MEAN|5.81||0.2|TWO_SIDED|95.0|-4.17|19.49|||Regression, Linear|||||19.49|-4.17|0.20
71035653|NCT05511935|141580133|SUPERIORITY||Slope|-9.29|STANDARD_ERROR_OF_MEAN|10.74||0.39|TWO_SIDED|95.0|-31.15|12.56|||Regression, Linear|||||12.56|-31.15|0.39
71096842|NCT00927186|141702709|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)|||||||0.268
71096843|NCT00927186|141702710|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71096844|NCT00927186|141702711|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.025
71035654|NCT05090839|141580134|EQUIVALENCE|The 95% confidence interval is used to assess the difference between the means of the 2 x 2 (English vs. Spanish) and (Trauma vs. Non-trauma) writing groups.|variance explained by the IV.|0.072|||<|0.05|TWO_SIDED|95.0|0.0|0.234|||ANOVA|||||.234|.0000|<0.05
70980976|NCT00733902|141469537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.53|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.04|-1.02|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.02|-2.04|<0.001
70980977|NCT00733902|141469537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.56|-0.51|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.51|-1.56|<0.001
70980978|NCT00733902|141469537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.52|-0.46|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.46|-1.52|<0.001
70980979|NCT00733902|141469537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.37|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.9|-0.85|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.85|-1.90|<0.001
70980980|NCT00733902|141469537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.27||0.03|TWO_SIDED|95.0|-1.12|-0.06|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.06|-1.12|0.030
70980981|NCT00733902|141469537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.27||0.002|TWO_SIDED|95.0|-1.39|-0.32|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.32|-1.39|0.002
71035655|NCT05090839|141580136|EQUIVALENCE|The 95% confidence interval is used to assess the difference between the means of the 2 x 2 (English vs. Spanish) and (Trauma vs. Non-trauma) writing groups.|Mean Difference (Final Values)|0.358|||<|0.05|TWO_SIDED|95.0|0.0|0.554|||ANOVA|||This is a comparison that is specific to the contrast of visualizing traumatic versus stressful events.||.554|0|<0.05
71096845|NCT00927186|141702712|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)|||||||0.012
71096846|NCT00927186|141702712|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)|||||||0.092
70980982|NCT00733902|141469537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.43|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.96|-0.9|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.90|-1.96|<0.001
70980983|NCT00733902|141469537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.28||0.085|TWO_SIDED|95.0|-1.03|0.07|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.07|-1.03|0.085
70980984|NCT00733902|141469537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.28||0.026|TWO_SIDED|95.0|-1.18|-0.08|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.08|-1.18|0.026
70980985|NCT00733902|141469537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.94|-0.84|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.84|-1.94|<0.001
70980986|NCT00733902|141469540|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.49|-0.14|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.14|-0.49|<0.001
70980987|NCT00733902|141469540|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.09||0.486|TWO_SIDED|95.0|-0.24|0.11|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.11|-0.24|0.486
70980988|NCT00733902|141469540|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.09||0.008|TWO_SIDED|95.0|-0.42|-0.06|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.06|-0.42|0.008
70980989|NCT00733902|141469540|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.63|-0.26|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.26|-0.63|<0.001
70980990|NCT00733902|141469540|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.64|-0.28|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.28|-0.64|<0.001
70980991|NCT00733902|141469540|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.76|-0.39|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.39|-0.76|<0.001
70980992|NCT00733902|141469540|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.53|-0.16|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.16|-0.53|<0.001
70980993|NCT00733902|141469540|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.54|-0.17|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.17|-0.54|<0.001
70980994|NCT00733902|141469540|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.85|-0.49|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.49|-0.85|<0.001
70980995|NCT00733902|141469540|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.63|-0.25|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.25|-0.63|<0.001
71096847|NCT00927186|141702713|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 1 month.|t-test, 2 sided|||||||<0.001
70980996|NCT00733902|141469540|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.57|-0.19|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.19|-0.57|<0.001
70980997|NCT00733902|141469540|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.8|-0.42|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.42|-0.80|<0.001
70980998|NCT00733902|141469540|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.1||0.035|TWO_SIDED|95.0|-0.42|-0.02|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.02|-0.42|0.035
70980999|NCT00733902|141469540|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.125|TWO_SIDED|95.0|-0.36|0.04|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.04|-0.36|0.125
71035656|NCT05090839|141580137|EQUIVALENCE|The 95% confidence interval is used to assess the difference between the means of the 2 x 2 (English vs. Spanish) and (Trauma vs. Non-trauma) writing groups.|Mean Difference (Final Values)|0.51|||<|0.05|TWO_SIDED|95.0|0.0|0.676|||ANOVA|||||.676|.000|<0.05
71035657|NCT03913377|141580138|EQUIVALENCE|A statistically significant difference in NIBUT/NIKBUT between Test lens and Spectacles was concluded if the upper confidence limit of the 95% CI is below zero or the lower limit is above zero.|LS Mean Difference|-2.79|STANDARD_ERROR_OF_MEAN|0.678|||TWO_SIDED|95.0|-4.14|-1.44|||Mixed Model Analysis|Kenward and Roger method was used for denominator degrees of freedom.|LS Mean difference was calculated as Test minus Control|The null and alternative hypotheses for testing significant difference between Test lens and Spectacles among habitual lens users with respect to NIBUT/NIKBUT.||-1.44|-4.14|
71035658|NCT03913377|141580139|OTHER|Estimated 95% confidence intervals for the point estimates of Test and Control|Mean Proportion|85.59|STANDARD_ERROR_OF_MEAN|1.038|||TWO_SIDED|95.0|43.2|97.89|||Mixed Model Analysis|||Point estimates for Test and Control with 95% confidence intervals||97.89|43.2|
71035659|NCT03913377|141580139|OTHER|Estimated 95% confidence intervals for the point estimates of Test and Control|Mean Proportion|84.17|STANDARD_ERROR_OF_MEAN|0.871|||TWO_SIDED|95.0|48.67|96.75|||Mixed Model Analysis|||Point estimates for Test and Control with 95% confidence intervals||96.75|48.67|
71035660|NCT03913377|141580140|OTHER|Estimated 95% confidence intervals for the point estimates of test.|Mean|0.52|STANDARD_ERROR_OF_MEAN|0.053|||TWO_SIDED|95.0|0.4|0.65|||Mixed Model Analysis|Kenward and Rogers Metod was used for degrees of freedom|||Point estimate was calculated for Test.|0.65|0.40|
71035661|NCT03913377|141580140|OTHER|Estimated 95% confidence intervals for the point estimates of Control.|Mean|0.13|STANDARD_ERROR_OF_MEAN|0.036|||TWO_SIDED|95.0|-0.19|0.44|||Mixed Model Analysis|Kenward and Rogers Metod was used for degrees of freedom|||Point estimates were calculated for Control.|0.44|-0.19|
71035662|NCT03913377|141580141|OTHER|Estimated 95% confidence intervals for the point estimates of Test.|Mean Proportion|30.7|STANDARD_ERROR_OF_MEAN|19.87|||TWO_SIDED|95.0|6.5|73.8|||Mixed Model Analysis||Point estimates were calculated for Test|||73.8|6.5|
71035663|NCT03913377|141580141|OTHER|Estimated 95% confidence intervals for the point estimates of Control.|Mean Proportion|27.9|STANDARD_ERROR_OF_MEAN|18.17|||TWO_SIDED|95.0|6.1|69.8|||Mixed Model Analysis||Point estimates were calculated for Control.|||69.8|6.1|
71035664|NCT00862563|141580226|SUPERIORITY_OR_OTHER||Difference between least squares means|-2.1|STANDARD_ERROR_OF_MEAN|1.1||0.06|TWO_SIDED|||||p\<0.05 considered to be significant|ANOVA|||Comparison of Week 10 means for mean drinks per day obtained for the placebo and zonisamide groups. Means used for the analysis are least means squares from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.06
71096848|NCT00927186|141702713|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 3 months.|t-test, 2 sided|||||||<0.001
71035665|NCT00862563|141580226|SUPERIORITY_OR_OTHER||Difference between least squares means|-3.0|STANDARD_ERROR_OF_MEAN|1.1||0.008|TWO_SIDED|||||p\< 0.05 was considered to be significant.|ANOVA|||Comparison of Week 11 means for mean drinks per day obtained for the placebo and zonisamide groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.008
71096849|NCT00927186|141702713|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 6 months.|t-test, 2 sided|||||||<0.001
70981000|NCT00733902|141469540|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.58|-0.18|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.18|-0.58|<0.001
70981001|NCT00733902|141469541|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.49|-0.14|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.14|-0.49|<0.001
70981002|NCT00733902|141469541|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.09||0.486|TWO_SIDED|95.0|-0.24|0.11|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.11|-0.24|0.486
70981003|NCT00733902|141469541|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.09||0.008|TWO_SIDED|95.0|-0.42|-0.06|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.06|-0.42|0.008
70981004|NCT00733902|141469541|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.64|-0.28|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.28|-0.64|<0.001
70981005|NCT00733902|141469541|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.62|-0.26|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.26|-0.62|<0.001
71096850|NCT00927186|141702714|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71096851|NCT00927186|141702715|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 1 month.|t-test, 2 sided|||||||<0.001
70981006|NCT00733902|141469541|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.75|-0.39|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.39|-0.75|<0.001
70981007|NCT00733902|141469541|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.53|-0.16|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.16|-0.53|<0.001
70981008|NCT00733902|141469541|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.58|-0.22|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.22|-0.58|<0.001
70981009|NCT00733902|141469541|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.89|-0.52|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.52|-0.89|<0.001
70981010|NCT00733902|141469541|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.59|-0.22|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.22|-0.59|<0.001
70981011|NCT00733902|141469541|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.55|-0.18|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.18|-0.55|<0.001
70981012|NCT00733902|141469541|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.83|-0.46|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.46|-0.83|<0.001
70981013|NCT00733902|141469541|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.1||0.004|TWO_SIDED|95.0|-0.47|-0.09|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.09|-0.47|0.004
70981014|NCT00733902|141469541|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.55|-0.17|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.17|-0.55|<0.001
70981015|NCT00733902|141469541|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.77|-0.39|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.39|-0.77|<0.001
70981016|NCT00733902|141469541|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.1||0.09|TWO_SIDED|95.0|-0.37|0.03|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.03|-0.37|0.090
70981017|NCT00733902|141469541|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.053|TWO_SIDED|95.0|-0.39|0.0|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.00|-0.39|0.053
71035666|NCT00862563|141580226|SUPERIORITY_OR_OTHER||Difference between least squares means|-2.1|STANDARD_ERROR_OF_MEAN|1.2||0.07|TWO_SIDED|||||p\< 0.05 was considered to be significant.|Mixed Models Analysis|||Comparison of Week 12 mean for mean drinks per day obtained for the placebo and zonisamide groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.07
70981018|NCT00733902|141469541|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.7|-0.3|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.30|-0.70|<0.001
70981019|NCT01773473|141469581|NON_INFERIORITY_OR_EQUIVALENCE|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|0.17|||||TWO_SIDED|95.0|-0.01|0.35||||||||0.35|-0.01|
70981020|NCT01440101|141469681|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value obtained from the Mann-Whitney U test stratified by the presence or absence of Gd+ lesions at baseline.|Wilcoxon (Mann-Whitney)|||||||<0.001
70981021|NCT01440101|141469684|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value obtained from the Van Elteren test stratified by the presence or absence of Gd+ lesions at baseline.|Van Elteren test|||||||<0.001
70981022|NCT01440101|141469685|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon rank sum test|||||||0.006
70981023|NCT01440101|141469686|SUPERIORITY_OR_OTHER||Difference in proportions|0.404|||<|0.001|TWO_SIDED|95.0|0.223|0.586|||Fisher Exact|||Relapse-free proportions compared using a two-sided Fisher exact test. In the analysis, participants with unknown status are considered to have relapsed.||0.586|0.223|<0.001
70981024|NCT01440101|141469687|SUPERIORITY_OR_OTHER|||||||0.729||||||P-value for comparison between the treated and placebo groups was based on analysis of covariance, adjusted for the baseline VAS score.|ANCOVA|||Change from Baseline to Week 12||||0.729
70981025|NCT01440101|141469687|SUPERIORITY_OR_OTHER|||||||0.942||||||P-value for comparison between the treated and placebo groups was based on analysis of covariance, adjusted for the baseline VAS score.|ANCOVA|||Change from Baseline at Week 24||||0.942
70981026|NCT00636818|141469701|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||<0.001
70981027|NCT00636818|141469702|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||<0.001
70981028|NCT00636818|141469703|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||<0.001
71035667|NCT00862563|141580226|SUPERIORITY_OR_OTHER||Difference between least squares means.|-3.4|STANDARD_ERROR_OF_MEAN|1.1||0.003|TWO_SIDED|||||p\<0.05 is considered as being significant.|ANOVA|||Comparison of Week 10 mean for mean drinks per day obtained for the placebo and topiramate groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates,||||0.003
71096852|NCT00927186|141702715|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 3 months.|t-test, 2 sided|||||||<0.001
70981029|NCT00636818|141469704|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.013
71035668|NCT00862563|141580226|SUPERIORITY_OR_OTHER||Difference between least squares means|-4.4|STANDARD_ERROR_OF_MEAN|1.1||0.0002|TWO_SIDED||||||ANOVA|||Comparison of Week 11 means for mean drinks per day obtained for the placebo and topiramate groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates. .||||0.0002
71035669|NCT00862563|141580226|SUPERIORITY_OR_OTHER||Difference between least squares means|-4.1|STANDARD_ERROR_OF_MEAN|1.2||0.0007|TWO_SIDED||||||ANOVA|||Comparison of Week 12 means for mean drinks per day obtained for the placebo and topiramate groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.0007
71035670|NCT00862563|141580226|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.64|STANDARD_ERROR_OF_MEAN|1.1||0.15|TWO_SIDED|||||p\<0.05 considered to be significant|ANOVA|||Comparison of Week 10 means for mean drinks per day obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.15
71035671|NCT00862563|141580226|SUPERIORITY_OR_OTHER||Difference between least squares means|-2.9|STANDARD_ERROR_OF_MEAN|1.2||0.014|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison of Week 11 means for mean drinks per day obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariate values.||||0.014
71035672|NCT00862563|141580226|SUPERIORITY_OR_OTHER||Difference between least squares means|-2.0|STANDARD_ERROR_OF_MEAN|1.2||0.1|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison of Week 12 means for mean drinks per day obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means s from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.1
71035673|NCT00862563|141580227|SUPERIORITY_OR_OTHER||Mean difference Week 12|8.9|STANDARD_ERROR_OF_MEAN|3.6||0.015|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison between mean values obtained for the topiramate and placebo groups for Week 12. Model generated least mean squares were used for this analysis.||||0.015
70981030|NCT00636818|141469705|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.005
70981031|NCT00636818|141469706|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Word Test: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.005
70981032|NCT00636818|141469706|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Color Test: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.005
71035674|NCT00862563|141580227|SUPERIORITY_OR_OTHER||Mean Difference Week 12|0.98|STANDARD_ERROR_OF_MEAN|3.6||0.784|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison of means for the zonisamide and placebo group for Week 12. Mixed models generated means were used in this analysis.||||0.784
71035675|NCT00862563|141580227|SUPERIORITY_OR_OTHER||Mean difference Week 12|3.65|STANDARD_ERROR_OF_MEAN|3.3||0.264|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison of means for the levetiracetam and placebo groups for Week 12. Model generated least mean squares were used for this analysis.||||0.264
71035676|NCT00862563|141580228|SUPERIORITY_OR_OTHER||Difference between least squares means|-24.4|STANDARD_ERROR_OF_MEAN|9.7||0.013|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison of Week 10 means for mean percent heavy drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.013
71035677|NCT00862563|141580228|SUPERIORITY_OR_OTHER||Difference between least squares means|-20.9|STANDARD_ERROR_OF_MEAN|9.8||0.036|TWO_SIDED|||||p\<0.05 is considered to be significant|ANOVA|||Comparison of Week 11 means for mean percent heavy drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.036
71096853|NCT00927186|141702715|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 6 months.|t-test, 2 sided|||||||<0.001
70981033|NCT00636818|141469706|SUPERIORITY_OR_OTHER|||||||0.144||95.0||||P-value for Color-Word Test: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.144
70981034|NCT00636818|141469707|SUPERIORITY_OR_OTHER|||||||0.791||95.0||||P-value for Physical Component Summary: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.791
71096854|NCT00927186|141702716|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
70981035|NCT00636818|141469707|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Mental Component Summary: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||<0.001
70981036|NCT00636818|141469707|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||P-value for Physical Functioning: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.037
71096855|NCT00927186|141702717|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 1 month.|t-test, 2 sided|||||||<0.001
71096856|NCT00927186|141702717|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 3 months.|t-test, 2 sided|||||||<0.001
70981037|NCT00636818|141469707|SUPERIORITY_OR_OTHER|||||||0.446||95.0||||P-value for Role-Physical: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.446
70981038|NCT00636818|141469707|SUPERIORITY_OR_OTHER|||||||0.365||95.0||||P-value for Bodily Pain: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.365
70981039|NCT00636818|141469707|SUPERIORITY_OR_OTHER|||||||0.087||95.0||||P-value for General Health Perception: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.087
70981040|NCT00636818|141469707|SUPERIORITY_OR_OTHER|||||||0.043||95.0||||P-value for Vitality: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.043
71096857|NCT00927186|141702717|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 6 months.|t-test, 2 sided|||||||<0.001
70981041|NCT00636818|141469707|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||P-value for Social Functioning: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.086
70981042|NCT00636818|141469707|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value for Role-Emotional: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.010
70981043|NCT00636818|141469707|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Mental Health: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||<0.001
70981044|NCT01658514|141469727|SUPERIORITY_OR_OTHER||% Ratio of LS Means|51.5||||0.0011|TWO_SIDED|90.0|37.77|70.23||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Normal Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||70.23|37.77|0.0011
70981045|NCT01658514|141469727|SUPERIORITY_OR_OTHER||% Ratio of LS Means|73.8||||0.0733|TWO_SIDED|90.0|55.97|97.43||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Mild RI Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||97.43|55.97|0.0733
70981046|NCT01658514|141469727|SUPERIORITY_OR_OTHER||% Ratio of LS Means|56.7||||0.0028|TWO_SIDED|90.0|42.25|76.1||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Moderate RI Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||76.10|42.25|0.0028
70981047|NCT01658514|141469727|SUPERIORITY_OR_OTHER||% Ratio of LS Means|52.4||||0.0025|TWO_SIDED|90.0|37.61|73.02||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Severe RI Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||73.02|37.61|0.0025
70981048|NCT01658514|141469728|SUPERIORITY_OR_OTHER||% Ratio of LS Means|65.5||||0.0474|TWO_SIDED|90.0|46.32|92.68||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Normal Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||92.68|46.32|0.0474
70981049|NCT01658514|141469728|SUPERIORITY_OR_OTHER||% Ratio of LS Means|77.3||||0.1691|TWO_SIDED|90.0|56.72|105.41||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Mild RI Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||105.41|56.72|0.1691
70981050|NCT01658514|141469728|SUPERIORITY_OR_OTHER||% Ratio of LS Means|56.6||||0.0064|TWO_SIDED|90.0|40.73|78.63||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Moderate RI Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||78.63|40.73|0.0064
70981051|NCT01658514|141469728|SUPERIORITY_OR_OTHER||% Ratio of LS Means|54.6||||0.0097|TWO_SIDED|90.0|37.68|79.11||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Severe RI Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||79.11|37.68|0.0097
70981052|NCT01658514|141469729|SUPERIORITY_OR_OTHER|||||||0.9444|TWO_SIDED|||||R² for Placebo-adjusted Change from Pre-dose Value in Lactate Versus Metformin Concentration|Pearson Correlation|||||||0.9444
70981053|NCT01658514|141469729|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||R² for placebo-adjusted change from pre-dose value in lactate versus metformin concentration|Pearson Correlation|||||||<0.0001
70981054|NCT00702143|141469737|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups||||0.0002
70981055|NCT00702143|141469737|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups||||<0.0001
70981056|NCT00702143|141469737|SUPERIORITY_OR_OTHER|||||||0.0014||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups||||0.0014
70981057|NCT00702143|141469739|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||Analysis of variance P value testing for an overall difference in the mean cortical SUVR between the clinical diagnostic groups.||||<0.0001
70981058|NCT00702143|141469739|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR||||<0.0001
71096858|NCT00927186|141702718|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71096859|NCT01145222|141702719|SUPERIORITY|Overall comparison between remimazolam and midazolam||||||0.007|||||||Fisher Exact|||||||0.007
71096860|NCT01421134|141702722|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|1.37|<|0.0001|TWO_SIDED|95.0|-10.2|-4.8|||Mixed Models Analysis|||||-4.8|-10.2|<0.0001
70981059|NCT00702143|141469739|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR||||<0.0001
70981060|NCT00702143|141469739|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR||||0.0003
71096861|NCT01421134|141702723|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.157|<|0.0001|TWO_SIDED|95.0|-0.96|-0.34|||Mixed Models Analysis|||||-0.34|-0.96|<0.0001
71096862|NCT01421134|141702724|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|-3.1|-1.1|||Mixed Models Analysis|||||-1.1|-3.1|<0.0001
71096863|NCT01421134|141702725|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|1.21||0.0001|TWO_SIDED|95.0|-7.2|-2.4|||ANCOVA|||||-2.4|-7.2|0.0001
70981061|NCT00609622|141469771|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.705||||0.9963|TWO_SIDED|95.0|1.272|5.751|||Log Rank|||P-value was calculated from a 1-sided, log-rank test stratified for Eastern Cooperative Oncology Group (ECOG) Performance Status (0 vs. 1), Baseline Lactate Dehydrogenase (LDH): greater than (\>) 1.5 vs. less than or equal to (\<=) 1.5 \* upper limit of normal range (ULN), and Prior Adjuvant Treatment (yes vs. no).||5.751|1.272|0.9963
70981062|NCT00609622|141469772|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.618||||0.9289|TWO_SIDED|95.0|0.845|3.096|||Log Rank|||P-value was calculated from a 1-sided, log-rank test stratified for ECOG Performance Status (0 vs. 1), Baseline LDH: \>1.5 vs. \<=1.5 \* ULN, and Prior Adjuvant Treatment (yes vs. no).||3.096|0.845|0.9289
70981063|NCT00609622|141469775|SUPERIORITY_OR_OTHER||F-Distribution|3.956||||0.5898|TWO_SIDED|95.0|-10.412|18.324|||Chi-squared|||||18.324|-10.412|0.5898
70981064|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4||||0.0515|TWO_SIDED|95.0|-2.82|0.01|||t-test, 2 sided|||Differences in PWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||0.01|-2.82|0.0515
70981065|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.45||||0.0876|TWO_SIDED|95.0|-3.11|0.22|||t-test, 2 sided|||Differences in PWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||0.22|-3.11|0.0876
70981066|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.81||||0.0522|TWO_SIDED|95.0|-3.64|0.02|||t-test, 2 sided|||Differences in PWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||0.02|-3.64|0.0522
70981067|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.64||||0.1339|TWO_SIDED|95.0|-3.81|0.52|||t-test, 2 sided|||Differences in PWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||0.52|-3.81|0.1339
70981068|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.05||||0.4233|TWO_SIDED|95.0|-3.68|1.57|||t-test, 2 sided|||Differences in PWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||1.57|-3.68|0.4233
70981069|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.97||||0.2211|TWO_SIDED|95.0|-5.18|1.24|||t-test, 2 sided|||Differences in PWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||1.24|-5.18|0.2211
70981070|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41||||0.8184|TWO_SIDED|95.0|-3.22|4.04|||t-test, 2 sided|||Differences in PWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||4.04|-3.22|0.8184
70981071|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.9||||0.038|TWO_SIDED|95.0|0.57|17.23|||t-test, 2 sided|||Differences in PWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||17.23|0.57|0.0380
70981072|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.6||||0.3266|TWO_SIDED|95.0|-6.61|17.81|||t-test, 2 sided|||Differences in PWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||17.81|-6.61|0.3266
70981073|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.75||||0.4667|TWO_SIDED|95.0|-16.26|27.76|||t-test, 2 sided|||Differences in PWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||27.76|-16.26|0.4667
70981074|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in PWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
70981075|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64||||0.5587|TWO_SIDED|95.0|-2.8|1.52|||t-test, 2 sided|||Differences in PWB between treatment arms (EOT) was analyzed from a two-sample t-test.||1.52|-2.80|0.5587
71096864|NCT01421134|141702726|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-6.1|-2.9|||ANCOVA|||||-2.9|-6.1|<0.0001
70981076|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28||||0.6122|TWO_SIDED|95.0|-1.37|0.81|||t-test, 2 sided|||Differences in SWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||0.81|-1.37|0.6122
70981077|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51||||0.4642|TWO_SIDED|95.0|-1.87|0.86|||t-test, 2 sided|||Differences in SWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||0.86|-1.87|0.4642
70981078|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.94||||0.2105|TWO_SIDED|95.0|-2.41|0.54|||t-test, 2 sided|||Differences in SWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||0.54|-2.41|0.2105
70981079|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.09||||0.195|TWO_SIDED|95.0|-0.57|2.76|||t-test, 2 sided|||Differences in SWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||2.76|-0.57|0.1950
70981080|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.5779|TWO_SIDED|95.0|-1.55|2.75|||t-test, 2 sided|||Differences in SWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||2.75|-1.55|0.5779
70981081|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.67||||0.6314|TWO_SIDED|95.0|-2.15|3.5|||t-test, 2 sided|||Differences in SWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||3.50|-2.15|0.6314
70981082|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.51||||0.7554|TWO_SIDED|95.0|-2.85|3.87|||t-test, 2 sided|||Differences in SWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||3.87|-2.85|0.7554
70981083|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.94||||0.3781|TWO_SIDED|95.0|-13.22|5.34|||t-test, 2 sided|||Differences in SWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||5.34|-13.22|0.3781
70981084|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.85||||0.5715|TWO_SIDED|95.0|-13.83|8.13|||t-test, 2 sided|||Differences in SWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||8.13|-13.83|0.5715
70981085|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.58||||0.1271|TWO_SIDED|95.0|-19.08|3.93|||t-test, 2 sided|||Differences in SWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||3.93|-19.08|0.1271
70981086|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in SWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
70981087|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27||||0.6785|TWO_SIDED|95.0|-1.03|1.58|||t-test, 2 sided|||Differences in SWB between treatment arms (EOT) was analyzed from a two-sample t-test.||1.58|-1.03|0.6785
70981088|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.4623|TWO_SIDED|95.0|-1.63|0.74|||t-test, 2 sided|||Differences in EWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||0.74|-1.63|0.4623
71096865|NCT01421134|141702727|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.615|||<|0.0001|TWO_SIDED|95.0|3.251|13.459|||Regression, Logistic||Odds Ratio was based on a logistic regression of response, with treatment group, baseline MADRS total score, and pooled center as fixed effects.|||13.459|3.251|<0.0001
70981089|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.9302|TWO_SIDED|95.0|-1.31|1.2|||t-test, 2 sided|||Differences in EWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||1.20|-1.31|0.9302
70981090|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.7502|TWO_SIDED|95.0|-1.84|1.33|||t-test, 2 sided|||Differences in EWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||1.33|-1.84|0.7502
70981091|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.9335|TWO_SIDED|95.0|-2.12|1.95|||t-test, 2 sided|||Differences in EWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||1.95|-2.12|0.9335
70981092|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.9191|TWO_SIDED|95.0|-2.4|2.17|||t-test, 2 sided|||Differences in EWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||2.17|-2.40|0.9191
70981093|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.675|TWO_SIDED|95.0|-3.46|2.27|||t-test, 2 sided|||Differences in EWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||2.27|-3.46|0.6750
70981094|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.88||||0.5874|TWO_SIDED|95.0|-4.2|2.43|||t-test, 2 sided|||Differences in EWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||2.43|-4.20|0.5874
70981095|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.27||||0.4507|TWO_SIDED|95.0|-7.53|16.06|||t-test, 2 sided|||Differences in EWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||16.06|-7.53|0.4507
70981096|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.9||||0.3087|TWO_SIDED|95.0|-4.28|12.08|||t-test, 2 sided|||Differences in EWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||12.08|-4.28|0.3087
70981097|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.9635|TWO_SIDED|95.0|-16.26|15.76|||t-test, 2 sided|||Differences in EWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||15.76|-16.26|0.9635
70981098|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in EWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
70981099|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42||||0.6699|TWO_SIDED|95.0|-2.37|1.53|||t-test, 2 sided|||Differences in EWB between treatment arms (EOT) was analyzed from a two-sample t-test.||1.53|-2.37|0.6699
70981100|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.34||||0.0055|TWO_SIDED|95.0|-3.98|-0.7|||t-test, 2 sided|||Differences in FWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||-0.70|-3.98|0.0055
70981101|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.04||||0.2793|TWO_SIDED|95.0|-2.92|0.85|||t-test, 2 sided|||Differences in FWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||0.85|-2.92|0.2793
70981102|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09||||0.2999|TWO_SIDED|95.0|-3.17|0.99|||t-test, 2 sided|||Differences in FWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||0.99|-3.17|0.2999
70981103|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.27||||0.327|TWO_SIDED|95.0|-3.82|1.29|||t-test, 2 sided|||Differences in FWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||1.29|-3.82|0.3270
70981104|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.9779|TWO_SIDED|95.0|-2.39|2.45|||t-test, 2 sided|||Differences in FWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||2.45|-2.39|0.9779
70981105|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.8344|TWO_SIDED|95.0|-4.25|3.45|||t-test, 2 sided|||Differences in FWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||3.45|-4.25|0.8344
70981106|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.46||||0.5494|TWO_SIDED|95.0|-3.5|6.41|||t-test, 2 sided|||Differences in FWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||6.41|-3.50|0.5494
70981107|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.0||||0.0136|TWO_SIDED|95.0|3.15|22.85|||t-test, 2 sided|||Differences in FWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||22.85|3.15|0.0136
70981108|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.78||||0.0247|TWO_SIDED|95.0|2.26|25.29|||t-test, 2 sided|||Differences in FWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||25.29|2.26|0.0247
70981109|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0||||0.3527|TWO_SIDED|95.0|-12.91|22.91|||t-test, 2 sided|||Differences in FWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||22.91|-12.91|0.3527
70981110|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in FWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
70981111|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.76||||0.1309|TWO_SIDED|95.0|-4.05|0.53|||t-test, 2 sided|||Differences in FWB between treatment arms (EOT) was analyzed from a two-sample t-test.||0.53|-4.05|0.1309
70981112|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.36||||0.051|TWO_SIDED|95.0|-2.72|0.01|||t-test, 2 sided|||Differences in CCS between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||0.01|-2.72|0.0510
70981113|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74||||0.3858|TWO_SIDED|95.0|-2.44|0.95|||t-test, 2 sided|||Differences in CCS between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||0.95|-2.44|0.3858
71035678|NCT00862563|141580228|SUPERIORITY_OR_OTHER||Difference between least squares means|-22.8|STANDARD_ERROR_OF_MEAN|9.9||0.24|TWO_SIDED|||||p\< 0.05 is considered to be significant|ANOVA|||Comparison of Week 12 means for mean percent heavy drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.24
71096866|NCT01421134|141702728|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.27|||<|0.0001|TWO_SIDED|95.0|2.105|8.663|||Regression, Logistic|||||8.663|2.105|<0.0001
71035679|NCT00862563|141580228|SUPERIORITY_OR_OTHER||Difference between least squares means|-33.0|STANDARD_ERROR_OF_MEAN|9.0||0.0004|TWO_SIDED|||||p\<0.05 is considered to be significant.|ANOVA|||Comparison of Week 10 means for mean percent heavy drinking days obtained for the placebo and topiramate groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.0004
70981114|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.88||||0.3943|TWO_SIDED|95.0|-2.9|1.15|||t-test, 2 sided|||Differences in CCS between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||1.15|-2.90|0.3943
70981115|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.13||||0.3499|TWO_SIDED|95.0|-3.53|1.27|||t-test, 2 sided|||Differences in CCS between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||1.27|-3.53|0.3499
70981116|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.9567|TWO_SIDED|95.0|-2.64|2.5|||t-test, 2 sided|||Differences in CCS between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||2.50|-2.64|0.9567
70981117|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.77||||0.2901|TWO_SIDED|95.0|-5.12|1.58|||t-test, 2 sided|||Differences in CCS between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||1.58|-5.12|0.2901
70981118|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.07||||0.5857|TWO_SIDED|95.0|-5.05|2.92|||t-test, 2 sided|||Differences in CCS between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||2.92|-5.05|0.5857
70981119|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.9635|TWO_SIDED|95.0|-12.56|12.02|||t-test, 2 sided|||Differences in CCS between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||12.02|-12.56|0.9635
70981120|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4||||0.685|TWO_SIDED|95.0|-15.36|10.56|||t-test, 2 sided|||Differences in CCS between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||10.56|-15.36|0.6850
70981121|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.75||||0.4968|TWO_SIDED|95.0|-19.23|11.73|||t-test, 2 sided|||Differences in CCS between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||11.73|-19.23|0.4968
70981122|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in CCS between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
70981123|NCT00609622|141469777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.58||||0.5891|TWO_SIDED|95.0|-2.71|1.55|||t-test, 2 sided|||Differences in CCS between treatment arms (EOT) was analyzed from a two-sample t-test.||1.55|-2.71|0.5891
70981124|NCT00609622|141469778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.63||||0.5081|TWO_SIDED|95.0|-2.5|1.24|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||1.24|-2.50|0.5081
70981125|NCT00609622|141469778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.6977|TWO_SIDED|95.0|-2.67|1.79|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||1.79|-2.67|0.6977
70981126|NCT00609622|141469778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.76||||0.0797|TWO_SIDED|95.0|-5.85|0.33|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||0.33|-5.85|0.0797
70981127|NCT00609622|141469778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.22||||0.5808|TWO_SIDED|95.0|-5.62|3.17|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||3.17|-5.62|0.5808
70981128|NCT00609622|141469778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.03||||0.7046|TWO_SIDED|95.0|-6.44|4.38|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||4.38|-6.44|0.7046
70981129|NCT00609622|141469778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.18||||0.2052|TWO_SIDED|95.0|-2.4|10.76|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||10.76|-2.40|0.2052
70981130|NCT00609622|141469778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.27||||0.0483|TWO_SIDED|95.0|0.07|16.46|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||16.46|0.07|0.0483
70981131|NCT00609622|141469778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.93||||0.6832|TWO_SIDED|95.0|-16.41|24.26|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||24.26|-16.41|0.6832
70981132|NCT00609622|141469778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0||||0.9081|TWO_SIDED|95.0|-18.05|20.05|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||20.05|-18.05|0.9081
70981133|NCT00609622|141469778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.75||||0.7289|TWO_SIDED|95.0|-12.88|16.38|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||16.38|-12.88|0.7289
70981134|NCT00609622|141469778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
70981135|NCT00609622|141469778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74||||0.6921|TWO_SIDED|95.0|-4.43|2.95|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (EOT) was analyzed from a two-sample t-test.||2.95|-4.43|0.6921
70981136|NCT00609622|141469778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.9788|TWO_SIDED|95.0|-0.19|0.19|||t-test, 2 sided|||Differences in item 13 between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||0.19|-0.19|0.9788
70981137|NCT00609622|141469778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.2747|TWO_SIDED|95.0|-0.33|0.09|||t-test, 2 sided|||Differences in item 13 between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||0.09|-0.33|0.2747
70981138|NCT00609622|141469778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.2776|TWO_SIDED|95.0|-0.5|0.14|||t-test, 2 sided|||Differences in item 13 between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||0.14|-0.50|0.2776
70981139|NCT00609622|141469778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.1403|TWO_SIDED|95.0|-0.62|0.09|||t-test, 2 sided|||Differences in item 13 between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||0.09|-0.62|0.1403
71035680|NCT00862563|141580228|SUPERIORITY_OR_OTHER||Difference between least squares means|-29.7|STANDARD_ERROR_OF_MEAN|9.2||0.0015|TWO_SIDED|||||p\< 0.05 is considered to be significant|ANOVA|||Comparison of Week 11 means for mean percent heavy drinking days obtained for the placebo and topiramate groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.0015
71035681|NCT00862563|141580228|SUPERIORITY_OR_OTHER||Difference between least squares means|-37.7|STANDARD_ERROR_OF_MEAN|9.3|<|0.0001|TWO_SIDED|||||p\<0.05 is considered to be significant.|ANOVA|||Comparison of Week 12 means for mean percent heavy drinking days obtained for the placebo and topiramate groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||<0.0001
71096867|NCT01543503|141702778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.851|||<|0.001|TWO_SIDED|95.0|-1.112|-0.589|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor: Analysis is based on an analysis of covariance (ANCOVA) model with change from baseline in DAS28-ESR at 24 weeks as dependent variable; therapy, site country, and treatment as fixed effects; DAS28-ESR at baseline as covariates.||-0.589|-1.112|<0.001
71096868|NCT01543503|141702779|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.91|||<|0.001|TWO_SIDED|95.0|-1.204|-0.617|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor: Analysis is based on an ANCOVA model with change from baseline to 12 months in DAS28-ESR as dependent variable; therapy and treatment as fixed effects; DAS28-ESR at baseline as covariates.||-0.617|-1.204|<0.001
71096869|NCT01543503|141702780|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.23|||<|0.001|TWO_SIDED|95.0|-15.513|-10.947|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for ESR at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in ESR as a dependent variable; therapy and treatment as fixed effects; ESR at baseline as the covariate.||-10.947|-15.513|<0.001
70981140|NCT00609622|141469778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.9151|TWO_SIDED|95.0|-0.55|0.5|||t-test, 2 sided|||Differences in item 13 between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||0.50|-0.55|0.9151
70981141|NCT00609622|141469778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.34||||0.3277|TWO_SIDED|95.0|-0.36|1.05|||t-test, 2 sided|||Differences in item 13 between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||1.05|-0.36|0.3277
70981142|NCT00609622|141469778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||1|TWO_SIDED|95.0|-0.86|0.86|||t-test, 2 sided|||Differences in item 13 between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||0.86|-0.86|1.0000
70981143|NCT00609622|141469778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.57||||0.5661|TWO_SIDED|95.0|-1.53|2.67|||t-test, 2 sided|||Differences in item 13 between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||2.67|-1.53|0.5661
70981144|NCT00609622|141469778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.7309|TWO_SIDED|95.0|-2.95|2.15|||t-test, 2 sided|||Differences in item 13 between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||2.15|-2.95|0.7309
70981145|NCT00609622|141469778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.25||||0.3273|TWO_SIDED|95.0|-2.16|4.66|||t-test, 2 sided|||Differences in item 13 between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||4.66|-2.16|0.3273
71096870|NCT01543503|141702780|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.648|||<|0.001|TWO_SIDED|95.0|-15.419|-9.876|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for ESR at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in ESR, as the dependent variable; therapy and treatment as fixed effects; ESR at baseline as the covariate.||-9.876|-15.419|<0.001
71096871|NCT01543503|141702781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.673|||<|0.001|TWO_SIDED|95.0|-10.271|-3.074|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for CRP at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in CRP as a dependent variable; therapy and treatment as fixed effects; CRP at baseline as the covariate.||-3.074|-10.271|<0.001
71096872|NCT01543503|141702781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.116||||0.659|TWO_SIDED|95.0|-6.074|3.842|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for CRP at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in CRP as the dependent variable; therapy and treatment as fixed effects; CRP at baseline as the covariate.||3.842|-6.074|0.659
70981146|NCT00609622|141469778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in item 13 between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
70981147|NCT00609622|141469778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.7108|TWO_SIDED|95.0|-0.39|0.27|||t-test, 2 sided|||Differences in item 13 between treatment arms (EOT) was analyzed from a two-sample t-test.||0.27|-0.39|0.7108
70981148|NCT01696461|141469779|OTHER||||||||||||||||||Percentage of donors mobilized with plerixafor. No comparison group was analyzed.|||
70981149|NCT01696461|141469780|OTHER||||||||||||||||||This is a descriptive analysis. Percentage of donor experiencing toxicities was assessed at 30, 60, 120, and 240 minutes after administration of plerixafor on each day of collection and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.3. Grade of maximum toxicity across all time points is reported.|||
70981150|NCT01696461|141469781|OTHER||||||||||||||||||This is a descriptive analysis. The number of donors experiencing toxicities was assessed at 30, 60, 120, and 240 minutes after administration of plerixafor on each day of collection and one, six, and 12 months post-donation. Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.3.|||
70981151|NCT01696461|141469782|OTHER||||||||||||||||||At 100 days after HCT, all patients in both the MAC and the RIC cohorts had achieved neutrophil engraftment. All patients in the MAC arm and 97% of patients in the RIC arm had achieved platelet engraftment. The median time to neutrophil engraftment was 13 and 15 days for MAC and RIC, respectively. The median time to platelet engraftment was 19 and 18 days for MAC and RIC, respectively.|||
70981152|NCT01696461|141469783|OTHER||||||||||||||||||"Full donor myeloid chimerism was achieved relatively quickly in both RIC and MAC groups (median 100% at day +28 in both RIC and MAC), but conversion to full donor T-cell chimerism appeared to be slower in the RIC patients.~T-cell chimerism for MAC patients: median donor cell % (range):~Day +28: 92(59-100)%, Day +100: 97(76-100)%, Day +180: 100(91-100)%, Day +365: 100(100-100)%~T-cell chimerism for RIC patients: median donor cell % (range):~Day +28: 80(50-100)%, Day +100: 84(64-100)%, Day +180: 95(74-100)%, Day +365: 100(87-100)%"|||
70981153|NCT01696461|141469784|OTHER||||||||||||||||||This is a descriptive outcome.There were no cases of primary graft failure.|||
70981154|NCT01696461|141469785|OTHER|||||||||||||||||The cumulative incidence of acute graft-vs-host disease was examined in the RIC and MAC groups but was not directly compared with a statistical test.|The incidence of acute GVHD was quantified by computing the cumulative incidence probability and an appropriate 95% confidence interval. Death was treated as a competing risk.|||
70981155|NCT01696461|141469786|OTHER||||||||||||||||||Immune reconstitution was measured by CD3+CD4+ and CD3+CD8+ T cells in the peripheral blood of patients at days 28, 100, 180, and 365 after HCT. Notably, median CD3+CD4+ cell counts were \>200/µL at all times analyzed, including day 28 in both MAC and RIC groups.|||
70981156|NCT01696461|141469787|OTHER|||||||||||||||||Groups were not directly compared using a statistical test.|Percentage of recipients at-risk for CMV reactivation who experienced a reactivation.|||
70981157|NCT01696461|141469788|OTHER|||||||||||||||||The probability of treatment-related mortality and disease relapse/progression were examined in the RIC and MAC cohorts but were not directly compared between the two groups using a statistical test.|The incidence of treatment-related mortality and relapse was quantified by computing the cumulative incidence probability and an appropriate 95% confidence interval. When computing the cumulative incidence probability of treatment-related mortality and relapse, relapse and treatment-related mortality, respectively, were considered as a competing risk.|||
70981158|NCT01696461|141469789|OTHER|||||||||||||||||The probability of progression free survival and overall survival were examined in the RIC and MAC cohorts but were not directly compared between the two groups using a statistical test.|Kaplan-Meier curves were used to estimate the probability of progression-free survival and overall survival. Progression-free survival at 1 year was 53% (95% CI, 36% to 71%) after MAC and 64% (95% CI, 47% to 79%) after RIC. Overall survival at 1 year was 63% (95% CI, 46% to 79%) after MAC and 70% (95% CI, 53% to 84%) after RIC.|||
70981159|NCT01696461|141469790|OTHER|||||||||||||||||This outcome measure is descriptive.|This outcome measure is descriptive. The median cell dose and range are reported.|||
70981160|NCT01696461|141469791|OTHER|||||||||||||||||The cumulative incidence of chronic graft-vs-host disease was examined in the RIC and MAC groups but was not directly compared with a statistical test.|The incidence of chronic GVHD was quantified by computing the cumulative incidence probability and an appropriate 95% confidence interval. Death was treated as a competing event.|||
70981161|NCT01696461|141469792|OTHER||||||||||||||||||This is a descriptive analysis. There were no cases of secondary graft failure.|||
70981162|NCT01696461|141469793|OTHER||||||||||||||||||This outcome measure is descriptive. The median cell dose and range are reported.|||
70981163|NCT03972488|141469794|SUPERIORITY||Hazard Ratio (HR)|0.276|||<|0.0001|TWO_SIDED|95.0|0.182|0.418|||Log Rank|Stratified one-sided P-value||||0.418|0.182|<0.0001
70981164|NCT03972488|141469795|SUPERIORITY||Stratified Odds Ratio|7.81|||<|0.0001|TWO_SIDED|95.0|3.32|18.4|||Stratified One-sided p-value|||||18.40|3.32|<0.0001
70981165|NCT03972488|141469796|SUPERIORITY||Hazard Ratio (HR)|0.856||||0.2222|TWO_SIDED|95.0|0.57|1.283|||Log Rank|Stratified one-sided P-value||Global Health Status||1.283|0.570|0.2222
70981166|NCT01380899|141469806|SUPERIORITY|IHC analyses revealed intense α-synuclein positive immunostaining in PD patients, showing small nodular deposits from 1 to 2 μm in diameter in the SCL of the epidermis including the epidermal component adjacent to hair follicles, and in cells from PSUs, while control subjects presented null immunoreaction. The α-synuclein inclusions in the two groups of patients were morphologically similar but quantitatively different. These inclusions appeared to be juxtanuclear.|Median Difference (Net)|57.9|STANDARD_DEVIATION|8.85|<|0.01|TWO_SIDED|95.0|44.9|62.6||The presence of alpha-synuclein aggregates expressed as % of cells with inclusions was tested for normality (Shapiro-Wilk test). Then, with the nonparametric Kruskal-Wallis followed by Mann-Whitney U tests (software Statistica 7.0 at 95% confidence).|Kruskal-Wallis|The groups were analyzed with Kruskal-Wallis followed by Mann-Whitney U tests.|The expression of the abnormal protein (alpha-synuclein) must be different between the three groups (PD, AP, and control)|The patients were stratified according to the clinical diagnosis made on the basis of the clinical findings, the MRI, and the progression of the disease. Both the clinical diagnosis and the semiquantitative histological analysis were carried out independently and blind to each other. The presence of aggregates of abnormal a-synuclein, expressed as the percentage of cells with positive inclusions in each experimental group, was tested for normality with the Shapiro-Wilk test.|The patients were stratified according to the clinical diagnosis based on the clinical findings, the MRI, and the progression of the disease. Both the clinical diagnosis and the semiquantitative histological analysis were carried out independently and blind to each other. The presence of aggregates of abnormal α-synuclein, expressed as the percentage of cells with positive inclusions in each experimental group, was tested for normality with the Shapiro-Wilk test. Next, the groups were analyzed with the nonparametric Kruskal-Wallis followed by Mann-Whitney U tests. One independent analysis was performed for each structure, namely the epidermis, PSU, and EG. Assessments were performed using the software Statistica 7.0 (Tulsa, OK) at 95% confidence.|62.6|44.9|< 0.01
70981167|NCT00768560|141469835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.69||||||90.0|-12.62|-6.77|||||40 mg BID minus 40 mg OD|The point estimate and 90% confidence interval of the difference of changes in SBP from baseline was estimated by using the analysis of variance (ANOVA) model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.||-6.77|-12.62|
70981168|NCT00768560|141469835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||||90.0|-2.87|2.98|||||80 mg OD minus 40 mg OD|The point estimate and 90% confidence interval of the difference of changes in SBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.||2.98|-2.87|
70981169|NCT00768560|141469835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.75||||||90.0|6.83|12.67|||||80 mg OD minus 40 mg BID|The point estimate and 90% confidence interval of the difference of changes in SBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.||12.67|6.83|
70981170|NCT00768560|141469835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.97||||||90.0|-5.5|-2.44|||||40 mg BID minus 40 mg OD|The point estimate and 90% confidence interval of the difference of changes in DBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.||-2.44|-5.50|
70981171|NCT00768560|141469835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||||90.0|-2.21|0.85|||||80 mg OD minus 40 mg OD|The point estimate and 90% confidence interval of the difference of changes in DBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.||0.85|-2.21|
70981172|NCT00768560|141469835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.29||||||90.0|1.76|4.82|||||80 mg OD minus 40 mg BID|The point estimate and 90% confidence interval of the difference of changes in DBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.||4.82|1.76|
70981173|NCT03375320|141469855|SUPERIORITY||||||<|0.0001|||||||One-sided unstratified log-rank|||||||<0.0001
71096873|NCT01543503|141702782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.576||||0.024|TWO_SIDED|95.0|-1.078|-0.075|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for SJC at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in SJC as the dependent variable; therapy and treatment as fixed effects; SJC at baseline as the covariate.||-0.075|-1.078|0.024
71096874|NCT01543503|141702782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.752||||0.002|TWO_SIDED|95.0|-1.238|-0.267|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for SJC at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in SJC, as the dependent variable; therapy and treatment as fixed effects; SJC, at baseline as the covariate.||-0.267|-1.238|0.002
70981174|NCT03375320|141469855|SUPERIORITY||||||<|0.0001|||||||One-sided unstratified log-rank|||||||<0.0001
70981175|NCT03375320|141469856|SUPERIORITY|||||||0.2438|||||||One-sided stratified log-rank|||||||0.2438
70981176|NCT03375320|141469856|SUPERIORITY|||||||0.4426|||||||One-sided stratified log-rank|||||||0.4426
70981177|NCT03375320|141469858|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
70981178|NCT03375320|141469858|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
70981179|NCT01128387|141469859|OTHER||Maximum Tolerated Dose|1.5|||||TWO_SIDED|||||||||Dose of Pantiumumab (in combination with Cisplatin \& Fluorouracil - see below)||||
70981180|NCT01128387|141469859|OTHER||Maximum Tolerated Dose|60.0|||||TWO_SIDED|||||||||Dose of Cisplatin||||
70981181|NCT01128387|141469859|OTHER||Maximum Tolerated Dose|750.0|||||TWO_SIDED|||||||||Dose of Fluorourcil||||
70981182|NCT01021111|141469864|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||The values from the three jumps were averaged in order to have one mean value per subject per session. Paired Student t-tests (baseline vs. follow-up) were used to evaluate the effects of the training.||||<0.01
70981183|NCT01021111|141469865|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Pearson|||The association between the change in the thigh coronal angular velocity from baseline to follow-up and the change in the knee abduction moment from baseline to follow-up was assessed with the Pearson correlation coefficient (R), alpha =0.05||||<0.05
70981184|NCT01535235|141469867|SUPERIORITY_OR_OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
70981185|NCT01535235|141469868|SUPERIORITY_OR_OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
70981186|NCT00389207|141469869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|0.016||||0.684||95.0|-0.062|0.095||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Controlling for screening VL and CD4+ categories (only 373 NVP patients due to empty cells)||||0.095|-0.062|0.684
70981187|NCT00389207|141469869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|0.025||||0.584||95.0|-0.065|0.115||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=186 NVP QD patients and N=193 ATZ/r patients.||||0.115|-0.065|0.584
70981188|NCT00389207|141469869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|0.009||||0.855||95.0|-0.084|0.101||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=187 NVP QD patients and N=193 ATZ/r patients.||||0.101|-0.084|0.855
70981189|NCT00389207|141469870|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.038||||0.321||95.0|-0.112|0.037||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=373 NVP QD patients and N=193 ATZ/r patients.||||0.037|-0.112|0.321
70981190|NCT00389207|141469881|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.461||||0.0403||95.0|0.22|0.966|||Regression, Cox|||||0.966|0.220|0.0403
70981191|NCT00389207|141469885|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.097||||0.0109||95.0|-0.171|-0.022||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=373 NVP QD+BID patients and N=193 ATZ/r patients||||-0.022|-0.171|0.0109
70981192|NCT00389207|141469885|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.072||||0.1033||95.0|-0.158|0.015||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=186 NVP QD patients and N=193 ATZ/r patients.||||0.015|-0.158|0.1033
70981193|NCT00389207|141469885|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.122||||0.0073||95.0|-0.212|-0.033||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=187 NVP QD patients and N=193 ATZ/r patients.||||-0.033|-0.212|0.0073
70981194|NCT00389207|141469886|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.117||||0.0031||95.0|-0.194|-0.04||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=373 NVP QD+BID patients and N=193 ATZ/r patients.||||-0.040|-0.194|0.0031
70981195|NCT00389207|141469886|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.096||||0.0365||95.0|-0.186|-0.006||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=186 NVP QD patients and N=193 ATZ/r patients.||||-0.006|-0.186|0.0365
70981196|NCT00389207|141469886|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.139||||0.0033||95.0|-0.231|-0.046||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=187 NVP QD patients and N=193 ATZ/r patients.||||-0.046|-0.231|0.0033
70981197|NCT00389207|141469889|NON_INFERIORITY_OR_EQUIVALENCE|H0: Difference in proportions = 0|Difference in proportions|0.001||||0.9784|TWO_SIDED|95.0|-0.065|0.066|||Cochran Chi-Squared|||week 48||0.066|-0.065|0.9784
70981198|NCT00389207|141469889|NON_INFERIORITY_OR_EQUIVALENCE|H0: Difference in proportions = 0|Difference in proportions|0.064||||0.0331|TWO_SIDED|95.0|0.005|0.123|||Cochran Chi-Squared|||week 96||0.123|0.005|0.0331
70981199|NCT00389207|141469889|NON_INFERIORITY_OR_EQUIVALENCE|H0: Difference in proportions = 0|Difference in proportions|0.058||||0.0691|TWO_SIDED|95.0|-0.005|0.121|||Cochran Chi-Squared|||week 144||0.121|-0.005|0.0691
70981200|NCT00389207|141469889|NON_INFERIORITY_OR_EQUIVALENCE|H0: Difference in proportions = 0|Difference in proportions|-0.023||||0.4585|TWO_SIDED|95.0|-0.084|0.038|||Cochran Chi-Squared|||week 48||0.038|-0.084|0.4585
70981201|NCT00389207|141469889|NON_INFERIORITY_OR_EQUIVALENCE|H0: Difference in proportions = 0|Difference in proportions|0.015||||0.5438|TWO_SIDED|95.0|-0.034|0.064|||Cochran Chi-Squared|||week 96||0.064|-0.034|0.5438
70981202|NCT00389207|141469889|NON_INFERIORITY_OR_EQUIVALENCE|H0: Difference in proportions = 0|Difference in proportions|0.016||||0.5659|TWO_SIDED|95.0|-0.039|0.071|||Cochran Chi-Squared|||week 144||0.071|-0.039|0.5659
71035682|NCT00862563|141580228|SUPERIORITY_OR_OTHER||Difference between least squares means|-20.7|STANDARD_ERROR_OF_MEAN|10.0||0.04|TWO_SIDED|||||p\< 0.05 is considered to be significant|ANOVA|||Comparison of Week 10 means for mean percent heavy drinking days obtained for the placebo and levetiracetam groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.04
70981203|NCT00389207|141469890|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.692||||0.0002||95.0|0.57|0.839|||Regression, Cox|||||0.839|0.570|0.0002
70981204|NCT00389207|141469890|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.0001||95.0|0.519|0.764|||Regression, Cox|||Cox regression on responders only (N=289 in Nevirapine QD+BID and N=175 in Atazanvir/ritonavir)||0.764|0.519|<0.0001
70981205|NCT00389207|141469891|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.762||||0.1329||95.0|0.535|1.086|||Regression, Cox|||||1.086|0.535|0.1329
70981206|NCT00389207|141469892|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.731||||0.0444||95.0|0.539|0.992|||Regression, Cox|||||0.992|0.539|0.0444
71035683|NCT00862563|141580228|SUPERIORITY_OR_OTHER||Difference between least squares means|-23.3|STANDARD_ERROR_OF_MEAN|10.2||0.025|TWO_SIDED|||||p\< 0.05 is considered to be significant|ANOVA|||Comparison of Week 11 means for mean percent heavy drinking days obtained for the placebo and levetiracetam groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.025
70981207|NCT03352245|141469936|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.2||0.889|TWO_SIDED||||||Mixed Models Analysis|||||||0.889
70981208|NCT03352245|141469937|SUPERIORITY||Mean Difference (Net)|-1.14|STANDARD_ERROR_OF_MEAN|0.88||0.2|TWO_SIDED||||||Mixed Models Analysis|||||||0.20
70981209|NCT03352245|141469938|SUPERIORITY||Mean Difference (Net)|7.79|STANDARD_ERROR_OF_MEAN|5.51||0.166|TWO_SIDED||||||Mixed Models Analysis|||||||0.166
70981210|NCT03352245|141469939|SUPERIORITY||Mean Difference (Net)|-0.64|STANDARD_ERROR_OF_MEAN|3.41||0.853|TWO_SIDED||||||Mixed Models Analysis|||||||0.853
71035684|NCT00862563|141580228|SUPERIORITY_OR_OTHER||Difference between least squares means|-24.8|STANDARD_ERROR_OF_MEAN|10.3||0.018|TWO_SIDED|||||p\<0.05 is considered to be significant|ANOVA|||Comparison of Week 12 means for mean percent heavy drinking days obtained for the placebo and levetiracetam groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.018
70981211|NCT03352245|141469940|SUPERIORITY||Mean Difference (Net)|17.04|STANDARD_ERROR_OF_MEAN|7.16||0.022|TWO_SIDED||||||Mixed Models Analysis|||||||0.022
70981212|NCT03352245|141469941|SUPERIORITY||Mean Difference (Net)|-0.43|STANDARD_ERROR_OF_MEAN|3.83||0.911|TWO_SIDED||||||Mixed Models Analysis|||||||0.911
70981213|NCT03352245|141469942|SUPERIORITY||Mean Difference (Net)|-5.18|STANDARD_ERROR_OF_MEAN|6.88||0.456|TWO_SIDED||||||Mixed Models Analysis|||||||0.456
70981214|NCT03352245|141469943|SUPERIORITY||Mean Difference (Net)|-2.05|STANDARD_ERROR_OF_MEAN|3.13||0.515|TWO_SIDED||||||Mixed Models Analysis|||||||0.515
70981215|NCT03352245|141469944|SUPERIORITY||Mean Difference (Net)|-8.65|STANDARD_ERROR_OF_MEAN|5.8||0.144|TWO_SIDED||||||Mixed Models Analysis|||||||0.144
70981216|NCT03352245|141469945|SUPERIORITY||Mean Difference (Net)|0.41|STANDARD_ERROR_OF_MEAN|6.28||0.948|TWO_SIDED||||||Mixed Models Analysis|||||||0.948
70981217|NCT03352245|141469946|SUPERIORITY||Mean Difference (Net)|-8.62|STANDARD_ERROR_OF_MEAN|7.45||0.254|TWO_SIDED||||||Mixed Models Analysis|||||||0.254
70981218|NCT03352245|141469947|SUPERIORITY||Mean Difference (Net)|-13.31|STANDARD_ERROR_OF_MEAN|6.62||0.051|TWO_SIDED||||||Mixed Models Analysis|||||||0.051
70981219|NCT03352245|141469948|SUPERIORITY||Mean Difference (Net)|4.07|STANDARD_ERROR_OF_MEAN|8.71||0.643|TWO_SIDED||||||Mixed Models Analysis|||||||0.643
70981220|NCT03352245|141469949|SUPERIORITY||Mean Difference (Net)|-9.11|STANDARD_ERROR_OF_MEAN|8.5||0.29|TWO_SIDED||||||Mixed Models Analysis|||||||0.290
70981221|NCT03352245|141469950|SUPERIORITY||Mean Difference (Net)|9.99|STANDARD_ERROR_OF_MEAN|5.49||0.077|TWO_SIDED||||||Mixed Models Analysis|||||||0.077
70981222|NCT03352245|141469951|SUPERIORITY||Mean Difference (Net)|5.27|STANDARD_ERROR_OF_MEAN|4.38||0.237|TWO_SIDED||||||Mixed Models Analysis|||||||0.237
70981223|NCT03352245|141469952|SUPERIORITY||Mean Difference (Net)|1.15|STANDARD_ERROR_OF_MEAN|6.49||0.861|TWO_SIDED||||||Mixed Models Analysis|||||||0.861
70981224|NCT02690701|141469960|SUPERIORITY|This superiority trial compares secukinumab with placebo with a view of demonstrating the superiority of secukinumab over placebo with regards to a specific outcome measure.|Least Square Mean|-0.053|STANDARD_ERROR_OF_MEAN|0.059||0.3712|TWO_SIDED|95.0|-0.169|0.064|||ANCOVA|||Statistical analysis (Analysis of Covariance) of change from baseline in target to background ratio for regions of the aorta at Week 12 (Full Analysis Set)||0.064|-0.169|0.3712
70981225|NCT01442181|141469990|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Energy and fatigue 3 month vs 6 month in minimally invasive group||||0.03
70981226|NCT01442181|141469990|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of the fatigue and energy was done in baseline-3 month, and 6 month in each group. Minimally Invasive: baseline vs 3 month||||0.01
70981227|NCT01442181|141469990|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Energy and fatigue in medical therapy group; baseline vs 3 month||||0.49
71096875|NCT01543503|141702783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.62||||0.123|TWO_SIDED|95.0|-1.408|0.169|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for TJC at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in TJC as the dependent variable; therapy and treatment as fixed effects; TJC at baseline as the covariate.||0.169|-1.408|0.123
71096876|NCT01543503|141702783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.216||||0.004|TWO_SIDED|95.0|-2.039|-0.393|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for TJC at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in TJC as the dependent variable; therapy and treatment as fixed effects; TJC at baseline as the covariate.||-0.393|-2.039|0.004
71096877|NCT01543503|141702784|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.475|||<|0.001|TWO_SIDED|95.0|-5.481|-1.469|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for CDAI score at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in CDAI the dependent variable; therapy and treatment as fixed effects; CDAI at baseline as the covariate.||-1.469|-5.481|<0.001
71096878|NCT01543503|141702784|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.6|||<|0.001|TWO_SIDED|95.0|-6.708|-2.492|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for CDAI score at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in CDAI as the dependent variable; therapy and treatment as fixed effects; CDAI at baseline as the covariate.||-2.492|-6.708|<0.001
71035685|NCT00862563|141580229|SUPERIORITY_OR_OTHER||Difference between least squares means|-22.5|STANDARD_ERROR_OF_MEAN|7.8||0.005|TWO_SIDED|||||p\<0.05 is considered to be significant|ANOVA|||Comparison of Week 10 means for mean percent drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.005
71035686|NCT00862563|141580229|SUPERIORITY_OR_OTHER||Difference between least squares means|-24.1|STANDARD_ERROR_OF_MEAN|7.9||0.003|TWO_SIDED||||||ANOVA|||Comparison of Week 11 means for mean percent drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.003
71035687|NCT00862563|141580229|SUPERIORITY_OR_OTHER||Difference between least square means|-16.3|STANDARD_ERROR_OF_MEAN|8.0||0.044|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison of Week 12 means for mean percent drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.044
71035688|NCT00862563|141580229|SUPERIORITY_OR_OTHER||Difference between least squares means|-38.1|STANDARD_ERROR_OF_MEAN|9.0|<|0.0001|TWO_SIDED|||||p\< 0.05 is considered to be significant|ANOVA|||Comparison of Week 10 means for mean percent drinking days obtained for the placebo and topiramate. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factors. Baseline values were used as covariates.||||<0.0001
71035689|NCT00862563|141580229|SUPERIORITY_OR_OTHER||Difference between least squares means|-47.6|STANDARD_ERROR_OF_MEAN|9.1|<|0.0001|TWO_SIDED|||||p\<0.05 is considered to be significant.|ANOVA|||Comparison of Week 11 means for mean percent drinking days obtained for the placebo and topiramate. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||<0.0001
71035690|NCT00862563|141580229|SUPERIORITY_OR_OTHER||Difference between least squares means|-34.0|STANDARD_ERROR_OF_MEAN|9.2||0.0004|TWO_SIDED|||||p\<0.05 is considered to be significant.|ANOVA|||Week 12.Comparison of Week 12 means for mean percent drinking days obtained for the placebo and topiramate. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.0004
71035691|NCT00862563|141580229|SUPERIORITY_OR_OTHER||Difference between least squares means|-19.3|STANDARD_DEVIATION|8.0||0.017|TWO_SIDED|||||p\<0.05 is considered to be significant|ANOVA|||Comparison of Week 10 means for mean percent drinking days obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis. Baseline values were used as covariates.||||0.017
71035692|NCT00862563|141580229|SUPERIORITY_OR_OTHER||Difference between least squares means|-31.2|STANDARD_ERROR_OF_MEAN|8.1||0.0002|TWO_SIDED|||||p\<0.05 is considered to be significant.|ANOVA|||Comparison of Week 11 means for mean percent drinking days obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis. Baseline values were used as covariates.||||0.0002
71035693|NCT00862563|141580229|SUPERIORITY_OR_OTHER||Difference between least squares means|-18.5|STANDARD_ERROR_OF_MEAN|8.2||0.026|TWO_SIDED|||||p\< 0.05 is considered to be significant|ANOVA|||.Comparison of Week 12 means for mean percent drinking days obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis.Baseline values were used as covariates.||||0.026
71035694|NCT00862563|141580230|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p\< 0.01 is considered to be significant.|Mixed Models Analysis|p value is for the group x time interaction term.'||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Letter Fluency scores would change towards a downward direction for the zonisamide as compared to the placebo group resulting in significant treatment x time interaction.||||<0.0001
71035695|NCT00862563|141580230|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p\<0.01 is considered to be significant|Mixed Models Analysis|p value is for group x time interaction term for the comparison of data for the topiramate and placebo group.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Letter Fluency scores would change towards a downward direction for the topiramate as compared to the placebo group resulting in a significant treatment x time interaction.||||<0.0001
71096879|NCT01543503|141702784|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.229||||0.014|TWO_SIDED|95.0|-5.806|-0.652|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for SDAI score at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in SDAI as the dependent variable; therapy and treatment as fixed effects; SDAI at baseline as the covariate.||-0.652|-5.806|0.014
71096880|NCT01543503|141702784|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.245||||0.027|TWO_SIDED|95.0|-6.121|-0.37|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for SDAI score at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in SDAI as the dependent variable; therapy and treatment as fixed effects; SDAI at baseline as the covariate.||-0.370|-6.121|0.027
70981228|NCT01442181|141469990|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Energy and fatigue 3 month vs 6 month||||0.06
70981229|NCT01642212|141470013|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
70981230|NCT01642212|141470014|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-6.75||||0.0096|TWO_SIDED|95.0|-11.808|-1.687||LS mean estimates were determined using an ANCOVA model including treatment group as a factor and the baseline score as a covariate.|ANCOVA|||||-1.687|-11.808|0.0096
70981231|NCT01642212|141470015|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.49||||0.2649|TWO_SIDED|95.0|-6.895|1.92||LS mean estimates were determined using the ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 8||1.920|-6.895|0.2649
70981232|NCT01642212|141470015|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.91||||0.2878|TWO_SIDED|95.0|-8.322|2.501||LS mean estimates were determined using the ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 12||2.501|-8.322|0.2878
70981233|NCT01642212|141470017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|TWO_SIDED||||||Fisher Exact|||Analysis of \</= 15 Eosinophils/HPF||||0.0001
70981234|NCT01642212|141470017|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||Analysis of \</= 1 Eosinophils/HPF||||<0.0001
70981235|NCT01642212|141470018|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0206|TWO_SIDED||||||Pearson's chi-square|||Analysis of \>/= 30% DSQ score reduction||||0.0206
70981236|NCT01642212|141470018|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0275|TWO_SIDED||||||Pearson's chi-square|||Analysis of \>/= 50% DSQ score reduction||||0.0275
70981237|NCT01642212|141470019|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0026|TWO_SIDED||||||Fisher Exact|||Analysis of response and \>/= 30% DSQ score reduction||||0.0026
70981238|NCT01642212|141470019|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0199|TWO_SIDED||||||Fisher Exact|||Analysis of response and \>/= 50% DSQ score reduction||||0.0199
70981239|NCT01642212|141470020|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-22.34|||<|0.0001|TWO_SIDED|95.0|-30.345|-14.334|||ANCOVA|LS mean based on the ANCOVA model including treatment group as a factor and baseline as a covariate.||||-14.334|-30.345|<0.0001
70981240|NCT01642212|141470021|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.76|||<|0.0001|TWO_SIDED|95.0|-5.172|-2.358||LS mean estimates based on the ANCOVA model including treatment group as a factor and baseline value as a covariate.|ANCOVA|||||-2.358|-5.172|<0.0001
70981241|NCT01642212|141470022|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-35.5||||0.0002|TWO_SIDED|95.0|-53.438|-17.57||LS mean estimates based on the ANCOVA model including treatment group as a factor and baseline value as a covariate.|ANCOVA|||Analysis of proximal eosinophil count||-17.570|-53.438|0.0002
70981242|NCT01642212|141470022|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-59.56|||<|0.0001|TWO_SIDED|95.0|-84.173|-34.948||LS mean estimates based on the ANCOVA model including treatment group as a factor and baseline value as a covariate.|ANCOVA|||Analysis of mid- eosinophil count||-34.948|-84.173|<0.0001
70981243|NCT01642212|141470022|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-67.38|||<|0.0001|TWO_SIDED|95.0|-93.573|-41.18||LS mean estimates based on the ANCOVA model including treatment group as a factor and baseline value as a covariate.|ANCOVA|||Analysis of distal eosinophil count||-41.180|-93.573|<0.0001
70981244|NCT01642212|141470023|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-18.44||||0.0015|TWO_SIDED|95.0|-29.593|-7.293||LS mean estimates were based on the ANCOVA model including treatment group as a factor and baseline value as a covariate.|ANCOVA|||||-7.293|-29.593|0.0015
70981245|NCT01642212|141470024|SUPERIORITY_OR_OTHER_LEGACY|||||||0.117|TWO_SIDED|||||P-value for comparison of the treatment difference was determined by Cochran-Mantel-Haenszel row mean score test.|Cochran-Mantel-Haenszel|||Analysis of distribution of scores across all responses||||0.1170
70981246|NCT01642212|141470025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1947|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of heartburn||||0.1947
70981247|NCT01642212|141470025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8029|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of chest pain||||0.8029
70981248|NCT01642212|141470025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4963|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of regurgitation||||0.4963
70981249|NCT01642212|141470025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5257|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of abdominal pain||||0.5257
70981250|NCT01642212|141470025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5219|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of nausea||||0.5219
70981251|NCT01642212|141470025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2886|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of vomiting||||0.2886
70981252|NCT01642212|141470028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. Both responses (no change, worsened) were analyzed collectively.|Cochran-Mantel-Haenszel|||Analysis of symptoms of participants with no symptoms at baseline||||0.1600
70981253|NCT01642212|141470030|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0606|TWO_SIDED||||||Pearson's chi-square|||Analysis of \>/= 30% DSQ+pain score reduction||||0.0606
70981254|NCT01642212|141470030|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0165|TWO_SIDED||||||Pearson's chi-square|||Analysis of \>/= 50% DSQ+pain score reduction||||0.0165
70981255|NCT01642212|141470031|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7817|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.7817
70981256|NCT01642212|141470032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09||||0.1686|TWO_SIDED|95.0|-0.222|0.04||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 8||0.040|-0.222|0.1686
70981257|NCT01642212|141470032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03||||0.8046|TWO_SIDED|95.0|-0.269|0.21||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 12||0.210|-0.269|0.8046
70981258|NCT01642212|141470032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01||||0.9239|TWO_SIDED|95.0|-0.199|0.219||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 16||0.219|-0.199|0.9239
70981259|NCT01642212|141470033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.73||||0.4835|TWO_SIDED|95.0|-2.806|1.339||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 8||1.339|-2.806|0.4835
70981260|NCT01642212|141470033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.92||||0.0662|TWO_SIDED|95.0|-3.974|0.132||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 12||0.132|-3.974|0.0662
70981261|NCT01642212|141470033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.8||||0.1091|TWO_SIDED|95.0|-4.006|0.41||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 16||0.410|-4.006|0.1091
71035696|NCT00862563|141580230|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|p value is for interaction effect for the comparison of data for the levetiracetam and placebo groups.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Letter Fluency scores would change towards a downward direction for the levetiracetam as compared to the placebo group resulting in a significant treatment x time interaction.||||0.30
71035697|NCT00862563|141580231|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|p value is for the group x time interaction effect for the paired comparison of COWAT-category data for the zonisamide and placebo groups.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Category scores would change towards a downward direction for the zonisamide as compared to the placebo group resulting in significant treatment x time interaction.||||0.003
70981262|NCT00004980|141470034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.76|STANDARD_ERROR_OF_MEAN|0.514||0.005||95.0|-4.65|-0.86||a priori threshold for statistical significance was .05|t-test, 2 sided|degree of freedom = 48||||-.86|-4.65|.005
70981263|NCT00004980|141470035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.27|STANDARD_ERROR_OF_MEAN|0.327||0.002||95.0|0.507|2.03||a priori threshold for statistical significance was .05|t-test, 2 sided|degrees of freedom = 48||null hypothesis is that the groups are the same||2.03|.507|.002
71035698|NCT00862563|141580231|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||p\< 0.01 is considered to be significant.|Mixed Models Analysis|The p value shown is for the group x time interaction effect for the comparison of data from the topiramate and the placebo groups.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Category scores would change towards a downward direction for the topiramate as compared to the placebo group resulting in significant treatment x time interaction||||0.01
71096881|NCT01543503|141702785|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.03|||<|0.001|TWO_SIDED|95.0|-12.655|-5.404|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for Physician Global Assessment score at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in Physician Global Assessment of Disease Activity as the dependent variable; therapy and treatment as fixed effects; Physician Global Assessment of Disease Activity at baseline as covariates.||-5.404|-12.655|<0.001
70981264|NCT00004980|141470036|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.949|STANDARD_ERROR_OF_MEAN|0.524||0.001||95.0|-1.45|-0.44||A priori threshold for statistical significance was .05|t-test, 2 sided|degrees of freedom = 46||||-.44|-1.45|.001
70981265|NCT00004980|141470037|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||a priori threshold for statistical significance = .05|Chi-squared|||||||.01
70981266|NCT01299025|141470038|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71008533|NCT02140762|141525115|SUPERIORITY_OR_OTHER||Vaccine Effectiveness|46.0|||<|0.0001|TWO_SIDED|95.0|43.0|49.0|||Generalized Linear Model||VE is based on the relative risk (RR).The Poisson Distribution and Log Link options were used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects:treatment group, strain (and center).|H0 (Null Hypothesis): Vaccine Effectiveness (VE) ≤ 10%. If the lower limit of the 95% CI for VE is \>10% the null hypothesis is to be rejected and effectiveness declared. The VE at 1 month after the 2nd injection for each strain is defined as \[1-(% of subjects without bactericidal activity at 1:8 dilution in MenABCWY group / % of subjects without bactericidal activity at 1:8 dilution in MenACWY group)\]x100. The combined VE across all strains will be computed by mean of a generalized linear model.||49|43|<0.0001
71035699|NCT00862563|141580231|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|The p value is for the group x time interaction effect for the comparison of the levetiracetam and placebo groups.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Category scores would change towards a downward direction for the levetiracetam as compared to the placebo group resulting in significant treatment x time interaction||||0.36
71035700|NCT00862563|141580232|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||p\<0.01 is considered to be significant|Mixed Models Analysis|p value is for the group x time interaction effect||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that Digit span scores would change towards a downward direction for the zonisamide as compared to the placebo group resulting in significant treatment x time interaction.||||0.07
71035701|NCT00862563|141580232|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|p value shown is for the group X time interaction effect.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that age adjusted Digit Span scores would change towards a downward direction for the topiramate as compared to the placebo group resulting in significant treatment x time interaction.||||<0.0001
71035702|NCT00862563|141580232|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|p value shown is for the group x time interaction effect.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that Digit span scores would change towards a downward direction for the levetiracetam as compared to the placebo group resulting in significant treatment x time interaction.||||0.95
71035703|NCT00862563|141580233|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|p value shown is for the group x time effect.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that Spatial Span scores would change towards a downward direction for the zonisamide as compared to the placebo group resulting in significant treatment x time interaction.||||0.038
71035704|NCT00862563|141580233|SUPERIORITY_OR_OTHER|||||||0.0025|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|p value shown is for the group x time interaction effect.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that Digit span scores would change towards a downward direction for the topiramate as compared to the placebo group resulting in significant treatment x time interaction.||||0.0025
71035705|NCT00862563|141580233|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED|||||p\<0.01 is considered to be significant|Mixed Models Analysis|p value shown is for the group x time interaction effect.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that Digit span scores would change towards a downward direction for the levetiracetam as compared to the placebo group resulting in significant treatment x time interaction.||||0.3
71035706|NCT00840216|141580312|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|106.9||||||90.0|||||||Bioequivalence is established when the ratio of the mean falls within 80-125.|||||
71035707|NCT00840216|141580313|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|92.7||||||90.0|||||||Bioequivalence is established when ratio of the mean falls within 80-125.|||||
71035708|NCT00840216|141580314|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|93.0||||||90.0|||||||Bioequivalence is established when ratio of the mean falls within 80-125.|||||
71035709|NCT01642277|141580319|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.94||||0.052|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For symptom-severity score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size and non-normal distributions of symptom severity scores. The null hypothesis is that there is no difference between the two groups in symptom severity, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) symptom severity than the other group.||||.052
71035710|NCT01642277|141580319|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|2.06||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For coping score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outliers of coping scores. The null hypothesis is that there is no difference between the two groups in coping, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) coping than the other group.||||.04
71035711|NCT01642277|141580319|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|2.176||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the concern score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outlier of the concern scores. The null hypothesis is that there is no difference between the two groups in their concern, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) concern than the other group.||||.03
71035712|NCT01642277|141580319|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|0.9||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the sleep score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outliers of sleep scores. The null hypothesis is that there is no difference between the two groups in sleep scores, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) sleep scores than the other group.||||.37
71035713|NCT01642277|141580319|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|2.02||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For social score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outliers of social scores. The null hypothesis is that there is no difference between the two groups in social scores, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) social scores than the other group.||||.04
71096882|NCT01543503|141702785|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.237|||<|0.001|TWO_SIDED|95.0|-14.13|-6.345|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for Physician Global Assessment score at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in Physician Global Assessment of Disease Activity as the dependent variable; therapy and treatment as fixed effects; Physician Global Assessment of Disease Activity at baseline as covariates.||-6.345|-14.130|<0.001
71035714|NCT01642277|141580319|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|2.03||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the overall health related quality of life (HRQL) score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outliers of HRQL scores. The null hypothesis is that there is no difference between the two groups in health related quality of life, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) health realted quality of life than the other group.||||.04
71035715|NCT01642277|141580320|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-0.74||||0.46|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the obstructive discomfort score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in obstructive discomfort, and and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) obstructive discomfort than the other group.||||.46
71035716|NCT01642277|141580320|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.8||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the irritative score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in irritation, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) irritation than the other group.||||.07
71035717|NCT01642277|141580320|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.59||||0.11|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the stress score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in stress, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) stress than the other group.||||.11
71035718|NCT01642277|141580320|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.69||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the urinary distress inventory score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in urinary distress, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) urinary distress than the other group.||||.09
71096883|NCT01543503|141702789|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Log Rank|||||||<0.001
71096884|NCT01543503|141702793|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.146||||0.02|TWO_SIDED|95.0|-0.269|-0.024|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in HAQ-DI as dependent variable; therapy and treatment as fixed effects; HAQ-DI at baseline as covariates.||-0.024|-0.269|0.020
71096885|NCT01543503|141702793|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.164||||0.02|TWO_SIDED|95.0|-0.301|-0.026|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in HAQ-DI as dependent variable; therapy and treatment as fixed effects; HAQ-DI at baseline as covariates.||-0.026|-0.301|0.020
71035719|NCT01642277|141580320|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.68||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the general score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in general pelvic floor disease severity, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) general pelvic floor disease severity than the other group.||||.09
71035720|NCT01642277|141580320|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-0.23||||0.82|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the anterior score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in anterior pelvic floor disease severity, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) anterior pelvic floor disease severity than the other group.||||.82
71035721|NCT01642277|141580320|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.92||||0.06|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the posterior score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in posterior pelvic floor disease severity, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) posterior pelvic floor disease severity than the other group.||||.06
71035722|NCT01642277|141580320|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.85||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the pelvic organ prolapse distress score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in pelvic organ prolapse distress, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) pelvic organ prolapse distress than the other group.||||.07
71096886|NCT01543503|141702794|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.893||||0.032|TWO_SIDED|95.0|-7.457|-0.329|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in FACIT-F score as dependent variable; therapy and treatment as fixed effects; FACIT-F score at baseline as covariates.||-0.329|-7.457|0.032
71096887|NCT01543503|141702794|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.787||||0.168|TWO_SIDED|95.0|-6.763|1.189|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in FACIT-F score as dependent variable; therapy and treatment as fixed effects; FACIT-F score at baseline as covariates.||1.189|-6.763|0.168
71096888|NCT01543503|141702795|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.661||||0.009|TWO_SIDED|95.0|-9.912|-1.411|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in participant's VAS score as dependent variable; therapy and treatment as fixed effects; participant's VAS score at baseline as covariates.||-1.411|-9.912|0.009
70981267|NCT03577990|141470043|SUPERIORITY|Our sample (N = 90) had approximately 80% power (assuming 5 dropouts per arm) to detect an effect size of ∼.205 or greater at the α = .05 level of statistical significance, given a realistic range of simulated unstructured covariance matrices. An 11% rate of attrition was anticipated to yield a final sample of 80 participants, an average of 40 per arm. Participants who dropped out of the study prior to receiving the allotted intervention were not included in the analysis.|Mean Difference (Final Values)|0.125||||0.05|TWO_SIDED|||||P-values were computed according to a mixed-effects repeated measures model, appropriately constrained to baseline if indicated.|mixed-effects repeated measures||||For both referent (compared by month and treatment group) and constrained longitudinal data analysis (cLDA) models, p-values were computed for the main group (G), time (T), and interaction (G x T) effects. For the first 3 months of the referent arm (IT), data were compared with usual care. Consequently, months 1 - 6 in the statistical analysis corresponds to calendar months 4 - 9 of the data collection. Months 1 - 9 of the intervention arm (ITEC) reflects months 1 - 9 of the collection. Additionally, for the cLDA model, data in the referent arm (IT) were accordingly shifted such that the starting point on the y-axis for both arms were the same (i.e. y = 0).|||.05
70981268|NCT03577990|141470044|SUPERIORITY|Our sample (N = 90) had approximately 80% power (assuming 5 dropouts per arm) to detect an effect size of ∼.205 or greater at the α = .05 level of statistical significance, given a realistic range of simulated unstructured covariance matrices. An 11% rate of attrition was anticipated to yield a final sample of 80 participants, an average of 40 per arm. Participants who dropped out of the study prior to receiving the allotted intervention were not included in the analysis.|Mean Difference (Final Values)|1250.0||||0.05|TWO_SIDED|||||P-values were computed according to a mixed-effects repeated measures model, appropriately constrained to baseline if indicated.|mixed-effects repeated measures||||For both referent (compared by month and treatment group) and constrained longitudinal data analysis (cLDA) models, p-values were computed for the main group (G), time (T), and interaction (G x T) effects. For the first 3 months of the referent arm (IT), data were compared with usual care. Consequently, months 1 - 6 in the statistical analysis corresponds to calendar months 4 - 9 of the data collection. Months 1 - 9 of the intervention arm (ITEC) reflects months 1 - 9 of the collection. Additionally, for the cLDA model, data in the referent arm (IT) were accordingly shifted such that the starting point on the y-axis for both arms were the same (i.e. y = 0).|||.05
70981269|NCT03577990|141470045|SUPERIORITY|Our sample (N = 90) had approximately 80% power (assuming 5 dropouts per arm) to detect an effect size of ∼.205 or greater at the α = .05 level of statistical significance, given a realistic range of simulated unstructured covariance matrices. An 11% rate of attrition was anticipated to yield a final sample of 80 participants, an average of 40 per arm. Participants who dropped out of the study prior to receiving the allotted intervention were not included in the analysis.|Mean Difference (Final Values)|300.0||||0.05|TWO_SIDED|||||P-values were computed according to a mixed-effects repeated measures model, appropriately constrained to baseline if indicated.|mixed-effects repeated measures||||For both referent (compared by month and treatment group) and constrained longitudinal data analysis (cLDA) models, p-values were computed for the main group (G), time (T), and interaction (G x T) effects. For the first 3 months of the referent arm (IT), data were compared with usual care. Consequently, months 1 - 6 in the statistical analysis corresponds to calendar months 4 - 9 of the data collection. Months 1 - 9 of the intervention arm (ITEC) reflects months 1 - 9 of the collection. Additionally, for the cLDA model, data in the referent arm (IT) were accordingly shifted such that the starting point on the y-axis for both arms were the same (i.e. y = 0).|||.05
70981270|NCT03577990|141470047|SUPERIORITY|Our sample (N = 90) had approximately 80% power (assuming 5 dropouts per arm) to detect an effect size of ∼.205 or greater at the α = .05 level of statistical significance, given a realistic range of simulated unstructured covariance matrices. An 11% rate of attrition was anticipated to yield a final sample of 80 participants, an average of 40 per arm. Participants who dropped out of the study prior to receiving the allotted intervention were not included in the analysis.|Mean Difference (Final Values)|500.0||||0.05|TWO_SIDED|||||P-values were computed according to a mixed-effects repeated measures model, appropriately constrained to baseline if indicated.|mixed-effects repeated measures||||For both referent (compared by month and treatment group) and constrained longitudinal data analysis (cLDA) models, p-values were computed for the main group (G), time (T), and interaction (G x T) effects. For the first 3 months of the referent arm (IT), data were compared with usual care. Consequently, months 1 - 6 in the statistical analysis corresponds to calendar months 4 - 9 of the data collection. Months 1 - 9 of the intervention arm (ITEC) reflects months 1 - 9 of the collection. Additionally, for the cLDA model, data in the referent arm (IT) were accordingly shifted such that the starting point on the y-axis for both arms were the same (i.e. y = 0).|||.05
70981271|NCT01126580|141470151|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.22|||<|0.001|TWO_SIDED|95.0|-0.36|-0.08||The p-value is adjusted for multiplicity using a tree-gatekeeping strategy. To determine significance, the p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||The study was designed with 90% power to detect non-inferiority of 1.5 mg LY2189265 vs Metformin on HbA1c change from baseline at the 26-week primary endpoint with a margin of 0.4%, a standard deviation of 1.3%, and a 2-sided alpha of 0.05 assuming no true difference between treatments. This corresponds to 223 participants per arm, with an assumed drop-out rate of 11%.||-0.08|-0.36|<0.001
70981272|NCT01126580|141470151|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.15|||<|0.001|TWO_SIDED|95.0|-0.29|-0.01||The p-value is adjusted for multiplicity using a tree-gatekeeping strategy. To determine significance, the p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||||-0.01|-0.29|<0.001
70981273|NCT01126580|141470151|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22||||0.002|TWO_SIDED|95.0|-0.36|-0.08||Tree gatekeeping strategy to control the family-wise Type I error rate was applied.|ANCOVA|||Superiority analysis.||-0.08|-0.36|0.002
70981274|NCT01126580|141470151|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.15||||0.02|TWO_SIDED|95.0|-0.29|-0.01||Tree gatekeeping strategy to control the family-wise Type I error rate was applied.|ANCOVA|||Superiority analysis.||-0.01|-0.29|0.020
71096889|NCT01543503|141702795|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.802|||<|0.001|TWO_SIDED|95.0|-14.245|-5.36|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in participant's VAS score as dependent variable; therapy and treatment as fixed effects; participant's VAS score at baseline as covariates.||-5.360|-14.245|<0.001
71096890|NCT01543503|141702797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.108||||0.01|TWO_SIDED|95.0|-9.017|-1.2|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in Patient's Global Assessment of Disease as dependent variable; therapy and treatment as fixed effects; Patient's Global Assessment of Disease at baseline as covariates.||-1.200|-9.017|0.010
71096891|NCT01543503|141702797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.767|||<|0.001|TWO_SIDED|95.0|-12.161|-3.372|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in Patient's Global Assessment of Disease as dependent variable; therapy and treatment as fixed effects; Patient's Global Assessment of Disease at baseline as covariates.||-3.372|-12.161|<0.001
71096892|NCT00986583|141702801|SUPERIORITY_OR_OTHER||Ratio of medians|1.34||||0.018|TWO_SIDED|95.0|1.05|1.72||This is for the primary comparison at 20 minute|ANCOVA||Ratio of medians of myoglobin measured at 20 minute for statin users vs. non-statin users|||1.72|1.05|0.018
71096893|NCT03767894|141702825|OTHER|Descriptive analysis (paired sample t-test)|Mean Difference (Final Values)|1.36||||0.24|TWO_SIDED|||||a priori threshold: p\<0.05 p-value is adjusted for multiple comparisons using Bonferroni correction.|t-test, 2 sided|Adjustment for p-value is 2.||Baseline scores compared to Post Unassisted condition (ARAT performed unassisted/without the use of the MyHand device).||||0.24
71096894|NCT03767894|141702825|OTHER|Descriptive analysis (paired sample t-test)|Mean Difference (Final Values)|-1.72||||0.207|TWO_SIDED|||||a priori threshold: p\<0.05 p-value is adjusted for multiple comparisons using Bonferroni correction.|t-test, 2 sided|Adjustment for p-value is 2.||Post Unassisted condition (ARAT performed unassisted/without the use of the MyHand device) compared to Post Assisted condition (ARAT performed assisted with the use of the MyHand device).||||0.207
70981275|NCT01126580|141470152|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.19|||<|0.001|TWO_SIDED|95.0|-0.35|-0.02||The p-value is adjusted for multiplicity using a tree-gatekeeping strategy. To determine significance, the p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||||-0.02|-0.35|<0.001
70981276|NCT01126580|141470152|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.04|||<|0.001|TWO_SIDED|95.0|-0.2|0.12||The p-value is adjusted for multiplicity using a tree-gatekeeping strategy. To determine significance, the p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||||0.12|-0.20|<0.001
70981277|NCT01126580|141470152|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.024|TWO_SIDED|95.0|-0.35|-0.02||Tree gatekeeping strategy to control the family-wise Type I error rate was applied.|ANCOVA|||Superiority analysis.||-0.02|-0.35|0.024
70981278|NCT01126580|141470152|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.299|TWO_SIDED|95.0|-0.2|0.12||Tree gatekeeping strategy to control the family-wise Type I error rate was applied.|ANCOVA|||Superiority analysis.||0.12|-0.20|0.299
70981279|NCT01126580|141470153|SUPERIORITY_OR_OTHER|||||||0.023||||||Treatment comparison for HbA1c less than 7.0% at 26 weeks.|Regression, Logistic|||||||0.023
70981280|NCT01126580|141470153|SUPERIORITY_OR_OTHER|||||||0.021||||||Treatment comparison for HbA1c less than 7.0% at 26 weeks.|Regression, Logistic|||||||0.021
71096895|NCT03767894|141702826|OTHER|Descriptive analysis (paired sample t-test)|Mean Difference (Final Values)|2.64||||0.026|TWO_SIDED|||||a priori threshold: p\<0.05|Paired sample T-test|2-tailed||Baseline scores compared to Post Unassisted condition (UEMF performed unassisted/without the use of the MyHand device).||||0.026
71096896|NCT03767894|141702828|OTHER|Descriptive analysis (paired Wilcoxon)|Mean Difference (Final Values)|-1.09||||0.442|TWO_SIDED|||||a priori threshold: p\<0.05 p-value is adjusted for multiple comparisons using Bonferroni correction.|Wilcoxon (Mann-Whitney)|Adjustment for p-value is 2.||Baseline scores compared to Post Unassisted condition (BBT performed unassisted/without the use of the MyHand device) of the impaired (hemiparetic) hand.||||0.442
70981281|NCT01126580|141470153|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison for HbA1c less than or equal to 6.5% at 26 weeks.|Regression, Logistic|||||||<0.001
70981282|NCT01126580|141470153|SUPERIORITY_OR_OTHER|||||||0.011||||||Treatment comparison for HbA1c less than or equal to 6.5% at 26 weeks.|Regression, Logistic|||||||0.011
70981283|NCT01126580|141470153|SUPERIORITY_OR_OTHER|||||||0.001||||||Treatment comparison for HbA1c less than 7% at 52 weeks.|Regression, Logistic|||||||0.001
70981284|NCT01126580|141470153|SUPERIORITY_OR_OTHER|||||||0.269||||||Treatment comparison for HbA1c less than 7% at 52 weeks.|Regression, Logistic|||||||0.269
70981285|NCT01126580|141470153|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison for HbA1c less than or equal to 6.5% at 52 weeks.|Regression, Logistic|||||||<0.001
70981286|NCT01126580|141470153|SUPERIORITY_OR_OTHER|||||||0.134||||||Treatment comparison for HbA1c less than or equal to 6.5% at 52 weeks.|Regression, Logistic|||||||0.134
70981287|NCT01126580|141470154|SUPERIORITY_OR_OTHER|||||||0.079||||||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||||0.079
70981288|NCT01126580|141470154|SUPERIORITY_OR_OTHER|||||||0.451||||||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||||0.451
70981289|NCT01126580|141470154|SUPERIORITY_OR_OTHER|||||||0.025||||||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||||0.025
70981290|NCT01126580|141470154|SUPERIORITY_OR_OTHER|||||||0.402||||||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||||0.402
70981291|NCT01126580|141470155|SUPERIORITY_OR_OTHER|||||||0.061||||||Treatment comparison at 26 weeks.|ANCOVA|||||||0.061
70981292|NCT01126580|141470155|SUPERIORITY_OR_OTHER|||||||0.647||||||Treatment comparison at 26 weeks.|ANCOVA|||||||0.647
70981293|NCT01126580|141470155|SUPERIORITY_OR_OTHER|||||||0.022||||||Treatment comparison at 52 weeks.|ANCOVA|||||||0.022
70981294|NCT01126580|141470155|SUPERIORITY_OR_OTHER|||||||0.469||||||Treatment comparison at 52 weeks.|ANCOVA|||||||0.469
70981295|NCT01126580|141470156|SUPERIORITY_OR_OTHER|||||||0.811||||||Treatment comparison at 26 weeks.|ANCOVA|||||||0.811
71096897|NCT03767894|141702828|OTHER|Descriptive analysis (paired Wilcoxon)|Mean Difference (Final Values)|-1.0||||1|TWO_SIDED|||||a priori threshold: p\<0.05 p-value is adjusted for multiple comparisons using Bonferroni correction.|Wilcoxon (Mann-Whitney)|Adjustment for p-value is 2.||Post Unassisted condition (BBT performed unassisted/without the use of the MyHand device) compared to Post Assisted condition (BBT performed assisted with the use of the MyHand device).||||1.0
71096898|NCT00137280|141702887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.01|TWO_SIDED|95.0|1.47|3.58|||Regression, Logistic||Comparison group is the control (denominator)|||3.58|1.47|<0.01
71096899|NCT00137280|141702888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.02|STANDARD_ERROR_OF_MEAN|5.93||0.03|||||||ANCOVA|||||||.03
71096900|NCT00137280|141702889|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.01|TWO_SIDED|95.0|1.22|4.34|||Regression, Logistic||Comparison group is the control (denominator)|||4.34|1.22|<0.01
71096901|NCT00137280|141702890|SUPERIORITY_OR_OTHER|||||||0.11|||||||Chi-squared|||||||.11
71096902|NCT05001165|141702891|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-0.1|0.7|||Regression, Linear|||||0.7|-0.1|
71096903|NCT05001165|141702892|SUPERIORITY||Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|0.84|2.14|||Regression, Logistic|||||2.14|0.84|
71096904|NCT05001165|141702893|SUPERIORITY||Odds Ratio (OR)|1.06|||<|0.05|TWO_SIDED|95.0|0.64|1.76|||Regression, Logistic|||||1.76|0.64|<0.05
71096905|NCT05001165|141702894|SUPERIORITY||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.73|1.93|||Regression, Logistic|||||1.93|0.73|
71096906|NCT05001165|141702895|SUPERIORITY||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.68|2.05|||Regression, Logistic|||||2.05|0.68|
71096907|NCT05001165|141702896|SUPERIORITY||Odds Ratio (OR)|1.48|||||TWO_SIDED|95.0|0.88|2.51|||Regression, Logistic|||||2.51|0.88|
71096908|NCT05001165|141702897|SUPERIORITY||Odds Ratio (OR)|1.87|||||TWO_SIDED|95.0|0.99|3.64|||Regression, Logistic|||||3.64|0.99|
71096909|NCT05001165|141702898|SUPERIORITY||Odds Ratio (OR)|0.68|||||TWO_SIDED|95.0|0.34|1.33|||Regression, Logistic|||||1.33|0.34|
71096910|NCT04000724|141702903|SUPERIORITY||Average treatment effect|-0.54||||0.141|TWO_SIDED|95.0|-1.26|0.18|||Longitudinal Targeted Maximum Likelihood|||||0.18|-1.26|0.141
70981296|NCT01126580|141470156|SUPERIORITY_OR_OTHER|||||||0.003||||||Treatment comparison at 26 weeks.|ANCOVA|||||||0.003
70981297|NCT01126580|141470156|SUPERIORITY_OR_OTHER|||||||0.44||||||Treatment comparison at 52 weeks.|ANCOVA|||||||0.440
70981298|NCT01126580|141470156|SUPERIORITY_OR_OTHER|||||||0.001||||||Treatment comparison at 52 weeks.|ANCOVA|||||||0.001
70981299|NCT01126580|141470157|SUPERIORITY_OR_OTHER|||||||0.75||||||Treatment comparison at 26 weeks.|ANCOVA|||||||0.750
70981300|NCT01126580|141470157|SUPERIORITY_OR_OTHER|||||||0.003||||||Treatment comparison at 26 weeks.|ANCOVA|||||||0.003
70981301|NCT01126580|141470157|SUPERIORITY_OR_OTHER|||||||0.412||||||Treatment comparison at 52 weeks.|ANCOVA|||||||0.412
70981302|NCT01126580|141470157|SUPERIORITY_OR_OTHER|||||||0.001||||||Treatment comparison at 52 weeks.|ANCOVA|||||||0.001
70981303|NCT01126580|141470158|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of HOMA2-%B at 26 weeks.|Mixed Models Analysis|||||||<0.001
70981304|NCT01126580|141470158|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of HOMA2-%B at 26 weeks.|Mixed Models Analysis|||||||<0.001
70981305|NCT01126580|141470158|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of HOMA2-%B at 52 weeks.|Mixed Models Analysis|||||||<0.001
70981306|NCT01126580|141470158|SUPERIORITY_OR_OTHER|||||||0.003||||||Treatment comparison of HOMA2-%B at 52 weeks.|Mixed Models Analysis|||||||0.003
70981307|NCT01126580|141470158|SUPERIORITY_OR_OTHER|||||||0.001||||||Treatment comparison of HOMA2-%S at 26 weeks.|Mixed Models Analysis|||||||0.001
70981308|NCT01126580|141470158|SUPERIORITY_OR_OTHER|||||||0.01||||||Treatment comparison of HOMA2-%S at 26 weeks.|Mixed Models Analysis|||||||0.010
70981309|NCT01126580|141470158|SUPERIORITY_OR_OTHER|||||||0.077||||||Treatment comparison of HOMA2-%S at 52 weeks.|Mixed Models Analysis|||||||0.077
70981310|NCT01126580|141470158|SUPERIORITY_OR_OTHER|||||||0.004||||||Treatment comparison of HOMA2-%S at 52 weeks.|Mixed Models Analysis|||||||0.004
70981311|NCT00803114|141470187|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.22||||0.05||95.0|0.12|0.41|||Fisher Exact||Relative risk describes the risk of requiring additional analgesics in the first 24 hours postpartum with the denominator being the arm which received placebo.|Relative risk ratio estimation with 95% CI using exact methods||0.41|0.12|0.05
70981312|NCT00803114|141470188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|0.8||0.05||95.0|-5.7|-2.3|||t-test, 2 sided|degrees of freedom 226|The epidural morphine group represents the baseline of comparison for difference in means, with the placebo group requiring additional analgesics earlier.|||-2.3|-5.7|0.05
70981313|NCT00803114|141470189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.3||0.05||95.0|0.7|1.8|||t-test, 2 sided|degrees of freedom 212|Difference in VAS score when compared to the baseline group, subjects receiving epidural morphine|||1.8|0.7|0.05
70981314|NCT00803114|141470190|SUPERIORITY_OR_OTHER|||||||0.8||||||Fisher's exact test result did not reveal statistically significant differences between expected and real frequencies in any of the categories.|Fisher Exact|||||||0.80
70981315|NCT01697345|141470238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.092|STANDARD_DEVIATION|6.0378|<|0.0005|TWO_SIDED|95.0|-13.928|-6.256|||t-test, 2 sided|||||-6.256|-13.928|<0.0005
70981316|NCT01697345|141470239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_DEVIATION|0.88|<|0.0005|TWO_SIDED|95.0|-1.859|-0.741|||t-test, 2 sided|||||-0.741|-1.859|<0.0005
70981317|NCT01697345|141470240|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.625|STANDARD_DEVIATION|1.369||0.002|TWO_SIDED|95.0|-2.495|-0.755|||t-test, 2 sided|||||-0.755|-2.495|0.002
70981318|NCT01697345|141470241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_DEVIATION|1.876||0.018|TWO_SIDED|95.0|-2.692|-0.308|||t-test, 2 sided|||||-0.308|-2.692|0.018
70981319|NCT01697345|141470242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_DEVIATION|1.18168||0.005|TWO_SIDED|95.0|-1.9508|-0.4492|||t-test, 2 sided|||||-.44920|-1.95080|0.005
70981320|NCT01697345|141470243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_DEVIATION|1.355||0.001|TWO_SIDED|95.0|-2.761|-1.039|||t-test, 2 sided|||||-1.039|-2.761|0.001
70981321|NCT01697345|141470244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.567|STANDARD_DEVIATION|1.793|<|0.0005|TWO_SIDED|95.0|-3.706|-1.428|||t-test, 2 sided|||||-1.428|-3.706|<0.0005
70981322|NCT02770807|141470291|SUPERIORITY||Least squares mean difference|-1.37||||0.0847|TWO_SIDED|95.0|-2.932|0.19|||Mixed model for repeated measures|||Least squares means, and p-values are derived from a mixed model repeated measures analysis with baseline modified ICARS value as covariate and the fixed effects of treatment, age, sex, region and visit and the interaction term treatment-by-visit.||0.190|-2.932|0.0847
71035723|NCT00848536|141580327|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 1.5 mmHg.|Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-0.9|0.5|||||Treatment group differences were calculated as the mean IOP in the Travoprost APS group minus the mean IOP in the Travatan group. Non-inferiority was demonstrated if the upper 95% CL of the between treatment difference in mean IOP was \< 1.5 mmHg.|A hypothesis test was performed using a repeated measures analysis of variance model. For the test of non-inferiority, a two-sided 95% confidence intervals for the treatment group difference in mean IOP at each visit and time point was constructed based on analysis of variance.||0.5|-0.9|
71035724|NCT00848536|141580328|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 1.5 mmHg.|Median Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-0.8|0.6|||||Treatment group differences were calculated as the mean IOP in the Travoprost APS group minus the mean IOP in the Travatan group. Non-inferiority was demonstrated if the upper 95% CL of the between treatment difference in mean IOP was \< 1.5 mmHg.|A hypothesis test was performed using a repeated measures analysis of variance model. For the test of non-inferiority, a two-sided 95% confidence intervals for the treatment group difference in mean IOP at each visit and time point was constructed based on analysis of variance.||00.6|-0.8|
71035725|NCT00848536|141580329|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 1.5 mmHg.|Median Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-0.9|0.5|||||Treatment group differences were calculated as the mean IOP in the Travoprost APS group minus the mean IOP in the Travatan group. Non-inferiority was demonstrated if the upper 95% CL of the between treatment difference in mean IOP was \< 1.5 mmHg.|A hypothesis test was performed using a repeated measures analysis of variance model. For the test of non-inferiority, a two-sided 95% confidence intervals for the treatment group difference in mean IOP at each visit and time point was constructed based on analysis of variance.||0.5|-0.9|
71035726|NCT03317444|141580333|SUPERIORITY||Treatment difference in % of subjects|36.7|||<|0.0001|TWO_SIDED|95.0|23.5|48.9|||Fisher Exact|||% Subjects Who Met Endpoint (≥ 4 mEq/L Change from Baseline Serum Bicarbonate or Serum Bicarbonate in the Normal Range \[22 - 29 mEq/L\]): TRC101-Placebo||48.9|23.5|< 0.0001
71096911|NCT04000724|141702903|SUPERIORITY||Average treatment effect|-0.51||||0.123|TWO_SIDED|95.0|-1.16|0.14|||Longitudinal Targeted Maximum Likelihood|||||0.14|-1.16|0.123
71096912|NCT04000724|141702904|SUPERIORITY||Average treatment effect|-0.24||||0.127|TWO_SIDED|95.0|-0.56|0.07|||Longitudinal Targeted Maximum Likelihood|||||.07|-.56|.127
71096913|NCT04000724|141702904|SUPERIORITY||Average treatment effect|-0.02||||0.899|TWO_SIDED|95.0|-0.34|0.3|||Longitudinal Targeted Maximum Likelihood|||||.30|-.34|.899
70981323|NCT02770807|141470291|SUPERIORITY||Least squares mean difference|-1.4||||0.0765|TWO_SIDED|95.0|-2.957|0.152|||Mixed model for repeated measures|||Least squares means, and p-values are derived from a mixed model repeated measures analysis with baseline modified ICARS value as covariate and the fixed effects of treatment, age, sex, region and visit and the interaction term treatment-by-visit.||0.152|-2.957|0.0765
70981324|NCT02770807|141470292|SUPERIORITY||Odds Ratio (OR)|0.946||||0.8919|TWO_SIDED|95.0|0.426|2.099|||Regression, Logistic|||Logistic regression modeling (0/1), where 0 = No change or worsening and 1= improvement, with age (at 2 levels: \<10 years, ≥10 years), sex, treatment, region as fixed effects.||2.099|0.426|0.8919
70981325|NCT02770807|141470292|SUPERIORITY||Odds Ratio (OR)|1.848||||0.1255|TWO_SIDED|95.0|0.842|4.053|||Regression, Logistic|||"Logistic regression modeling (0/1), where 0 = No change or worsening and 1= improvement, with age (at 2 levels:~\<10 years, ≥10 years), sex, treatment, region as fixed effects."||4.053|0.842|0.1255
70981326|NCT02770807|141470293|SUPERIORITY||Odds Ratio (OR)|1.369||||0.4583|TWO_SIDED|95.0|0.597|3.144|||Ordinal Logistic Regression Analysis|||Odds ratio, confidence limits, and p-value derived using a proportional odds ordinal logistic regression analysis, with age (at 2 levels: \<10 years, ≥10 years), sex, treatment, region, visit, baseline CGI-S score, and treatment-by- visit interaction as fixed effects.||3.144|0.597|0.4583
71096914|NCT03467945|141702931|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|81.4421|||||TWO_SIDED|90.0|75.2805|88.1079||||||||88.1079|75.2805|
71096915|NCT03467945|141702931|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|102.293|||||TWO_SIDED|90.0|97.8819|106.9028||||||||106.9028|97.8819|
71096916|NCT03467945|141702931|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|81.0112|||||TWO_SIDED|90.0|74.8823|87.6417||||||||87.6417|74.8823|
71096917|NCT03467945|141702932|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|102.293|||||TWO_SIDED|90.0|97.8819|106.9028||||||||106.9028|97.8819|
71096918|NCT03467945|141702932|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|105.7255|||||TWO_SIDED|90.0|101.1665|110.49||||||||110.4900|101.1665|
71096919|NCT03467945|141702932|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|96.7533|||||TWO_SIDED|90.0|92.5812|101.1135||||||||101.1135|92.5812|
70981327|NCT02770807|141470293|SUPERIORITY||Odds Ratio (OR)|1.371||||0.4585|TWO_SIDED|95.0|0.595|3.16|||Ordinal Logistic Regression Analysis|||Odds ratio, confidence limits, and p-value derived using a proportional odds ordinal logistic regression analysis, with age (at 2 levels: \<10 years, ≥10 years), sex, treatment, region, visit, baseline CGI-S score, and treatment-by- visit interaction as fixed effects.||3.160|0.595|0.4585
70981328|NCT02770807|141470294|SUPERIORITY||Least squares means difference|-13.33||||0.7029|TWO_SIDED|95.0|-82.261|55.601|||ANCOVA|||Least squares means difference, associated statistics, and p-values derived using ANCOVA, with age (at 2 levels: \<10 years, \>=10 years), sex, treatment, region, and baseline VABS score as fixed effects.||55.601|-82.261|0.7029
71035727|NCT03317444|141580333|SUPERIORITY||Treatment difference in % of subjects|34.5|||<|0.0001|TWO_SIDED|95.0|21.2|46.8|||Fisher Exact|||% Subjects with ≥ 4 mEq/L Change from Baseline in Serum Bicarbonate: TRC101-Placebo||46.8|21.2|< 0.0001
71096920|NCT03467945|141702933|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|77.6923|||||TWO_SIDED|90.0|70.383|85.7606||||||||85.7606|70.3830|
70981329|NCT02770807|141470294|SUPERIORITY||Least squares means difference|-77.31||||0.0328|TWO_SIDED|95.0|-148.201|-6.421|||ANCOVA|||Least squares means difference, associated statistics, and p-values derived using ANCOVA, with age (at 2 levels: \<10 years, \>=10 years), sex, treatment, region, and baseline VABS score as fixed effects.||-6.421|-148.201|0.0328
70981330|NCT02799381|141470372|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|-15.05|||<|0.0001|TWO_SIDED|95.0|-21.47|-8.63||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|||-8.63|-21.47|<0.0001
70981331|NCT02799381|141470373|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|3.27|||<|0.0001|TWO_SIDED|95.0|1.71|4.83||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|If the primary efficacy variable was statistically significant, each of the secondary variables were to be tested using a fixed sequence as a gatekeeping procedure and at α level of 0.050. Testing was to cease at the point that a secondary variable failed to demonstrate statistical significance.||4.83|1.71|<0.0001
71035728|NCT03317444|141580333|SUPERIORITY||Treatment difference in % of subjects|33.1|||<|0.0001|TWO_SIDED|95.0|19.7|45.6|||Fisher Exact|||% Subjects with Serum Bicarbonate in the Normal Range (22 - 29 mEq/L): TRC101-Placebo||45.6|19.7|< 0.0001
71035729|NCT03317444|141580334|SUPERIORITY||Treatment difference in LS means|2.63|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|1.77|3.5|||Mixed-effect repeated measures model||Standard error presented above is for the LS mean.|Least Squares (LS) Mean Change from Baseline: TRC101-Placebo||3.5|1.77|< 0.0001
71035730|NCT02944617|141580336|OTHER|||||||1|||||||Fisher Exact|||||||1.00
71035731|NCT02944617|141580338|OTHER|||||||0.077|||||||Log Rank|||||||0.077
71035732|NCT00506831|141580339|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||Null hypothesis is that the mRSS is not significantly different at month 6 compared with baseline. Paired t-test was used to compare the mean mRSS at month 6 compared with baseline.||||0.005
71035733|NCT02488239|141580347|OTHER||||||<|0.001|||||||exact binomial rate|||||||<0.001
71035734|NCT02488239|141580348|OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71035735|NCT00835692|141580396|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Mean x 100|98.4||||||90.0|91.5|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106|91.5|
71035736|NCT00835692|141580397|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Means x 100|93.5||||||90.0|89.6|97.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||97.6|89.6|
71035737|NCT00835692|141580398|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Means x 100|93.5||||||90.0|89.5|97.7|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||97.7|89.5|
71035738|NCT01149733|141580399|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Geometric Means|97.9|||||TWO_SIDED|90.0|91.0|105.32|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||105.32|91.00|
71035739|NCT01149733|141580400|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Geometric Means|91.81|||||TWO_SIDED|90.0|87.72|96.1|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||96.10|87.72|
71035740|NCT01149733|141580401|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Geometric Means|90.64|||||TWO_SIDED|90.0|86.59|94.89|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||94.89|86.59|
71035741|NCT04667338|141580436|SUPERIORITY||||||=|0.5061|||||||Chi-squared|||Pharmacological||||=0.5061
71035742|NCT04667338|141580436|SUPERIORITY||||||=|0.2053|||||||Chi-squared|||Non-pharmacological||||=0.2053
71035743|NCT04667338|141580437|SUPERIORITY||||||=|0.4016|||||||Chi-squared|||||||=0.4016
71035744|NCT04667338|141580440|SUPERIORITY||||||=|0.5274|||||||Chi-squared|||Educational level ongoing or completed level of education||||=0.5274
71035745|NCT04667338|141580440|SUPERIORITY||||||=|0.7051|||||||Chi-squared|||Occupational status and occupation||||=0.7051
71035746|NCT04667338|141580440|SUPERIORITY||||||=|0.3543|||||||Chi-squared|||Civil status||||=0.3543
71035747|NCT04667338|141580440|SUPERIORITY||||||=|0.0368|||||||Chi-squared|||Living conditions||||=0.0368
71035748|NCT04667338|141580440|SUPERIORITY||||||=|0.3512|||||||Chi-squared|||Smoking status||||=0.3512
71035749|NCT04667338|141580440|SUPERIORITY||||||=|0.104|||||||Chi-squared|||Alcohol intake||||=0.1040
70981332|NCT02799381|141470374|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|-16.66|||<|0.0001|TWO_SIDED|95.0|-24.48|-8.85||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|If the primary efficacy variable was statistically significant, each of the secondary variables were to be tested using a fixed sequence as a gatekeeping procedure and at α level of 0.050. Testing was to cease at the point that a secondary variable failed to demonstrate statistical significance.||-8.85|-24.48|<0.0001
70981333|NCT02799381|141470375|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|-2.11|||<|0.0001|TWO_SIDED|95.0|-2.78|-1.44||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|If the primary efficacy variable was statistically significant, each of the secondary variables were to be tested using a fixed sequence as a gatekeeping procedure and at α level of 0.050. Testing was to cease at the point that a secondary variable failed to demonstrate statistical significance.||-1.44|-2.78|<0.0001
70981334|NCT02799381|141470376|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|-5.54|||=|0.0006|TWO_SIDED|95.0|-8.59|-2.49||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|If the primary efficacy variable was statistically significant, each of the secondary variables were to be tested using a fixed sequence as a gatekeeping procedure and at α level of 0.050. Testing was to cease at the point that a secondary variable failed to demonstrate statistical significance.||-2.49|-8.59|=0.0006
70981335|NCT02799381|141470377|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|-2.35|||=|0.0002|TWO_SIDED|95.0|-3.51|-1.19||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|If the primary efficacy variable was statistically significant, each of the secondary variables were to be tested using a fixed sequence as a gatekeeping procedure and at α level of 0.050. Testing was to cease at the point that a secondary variable failed to demonstrate statistical significance.||-1.19|-3.51|=0.0002
71008534|NCT02140762|141525115|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|25.5|||||TWO_SIDED|||||||||Vaccine effectiveness\<10% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
71035750|NCT04667338|141580440|SUPERIORITY||||||=|0.0202|||||||Chi-squared|||Exercise status||||=0.0202
71035751|NCT04667338|141580440|SUPERIORITY||||||=|0.3503|||||||Chi-squared|||Family history of narcolepsy||||=0.3503
71035752|NCT04667338|141580445|SUPERIORITY||||||=|0.0715|||||||Chi-squared|||General practitioner||||=0.0715
71035753|NCT04667338|141580445|SUPERIORITY||||||=|0.0929|||||||Chi-squared|||Neurologist||||=0.0929
71035754|NCT04667338|141580445|SUPERIORITY||||||=|0.3092|||||||Chi-squared|||Neuropediatrician||||=0.3092
71035755|NCT04667338|141580445|SUPERIORITY||||||=|0.4528|||||||Chi-squared|||Neurophysiologist||||=0.4528
71035756|NCT04667338|141580445|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Pneumologist||||<0.0001
71096921|NCT03467945|141702933|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|108.0819|||||TWO_SIDED|90.0|102.237|114.2609||||||||114.2609|102.2370|
71096922|NCT03467945|141702933|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|79.4367|||||TWO_SIDED|90.0|71.9633|87.6861||||||||87.6861|71.9633|
71035757|NCT04667338|141580445|SUPERIORITY||||||=|0.1785|||||||Chi-squared|||Somnologist||||=0.1785
71035758|NCT04667338|141580445|SUPERIORITY||||||=|0.1474|||||||Chi-squared|||Somnologist-unit||||=0.1474
71035759|NCT04667338|141580446|SUPERIORITY||||||=|0.2042|||||||Chi-squared|||Clinical history||||=0.2042
71035760|NCT04667338|141580446|SUPERIORITY||||||=|0.5818|||||||Chi-squared|||Clinical assessment: ESS||||=0.5818
71035761|NCT04667338|141580446|SUPERIORITY||||||=|0.0368|||||||Chi-squared|||Neurological assessment||||=0.0368
71035762|NCT04667338|141580446|SUPERIORITY||||||=|0.1128|||||||Chi-squared|||MSLT||||=0.1128
71035763|NCT04667338|141580446|SUPERIORITY||||||=|0.3396|||||||Chi-squared|||AHI||||=0.3396
71035764|NCT04667338|141580446|SUPERIORITY||||||=|0.6794|||||||Chi-squared|||Other procedures||||=0.6794
71035765|NCT04667338|141580446|SUPERIORITY||||||=|0.0138|||||||Chi-squared|||HLA typing||||=0.0138
71035766|NCT04667338|141580446|SUPERIORITY||||||=|0.0597|||||||Chi-squared|||Hypocretin-1 CSF or Orexin||||=0.0597
71096923|NCT03467945|141702934|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|108.0819|||||TWO_SIDED|90.0|102.237|114.2609||||||||114.2609|102.2370|
71035767|NCT04667338|141580447|SUPERIORITY||||||=|0.1171|||||||t-test, 2 sided|||||||=0.1171
71035768|NCT04667338|141580448|SUPERIORITY||||||=|0.3834|||||||t-test, 2 sided|||||||=0.3834
70922788|NCT03092726|141336670|SUPERIORITY||LS Mean (LSM) Difference|0.06|STANDARD_ERROR_OF_MEAN|0.26||0.59|TWO_SIDED|90.0|-0.38|0.5||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Differences of least squares (LS) means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a mixed-effect, repeated measures (MMRM) model with change from baseline to each week from weeks 1 to 8 as response, treatment, center (pooled where necessary), time (study weeks 1 to 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||0.50|-0.38|0.590
70922789|NCT03092726|141336674|SUPERIORITY||Difference of percentages|-6.6||||0.874|TWO_SIDED|90.0|-18.7|5.7||1-sided p-value is for comparison of ASP8062 30 mg with placebo using Fisher's Exact method.|Fisher Exact|||Week 8: Differences of the percentages were calculated by subtracting the percentage of placebo group from the percentage of ASP8062 30 mg group. Confidence Interval (CI) for each treatment group and the difference of the percentages was an exact unconditional confidence interval based on Santner-Snell approach.||5.7|-18.7|0.874
70922790|NCT03092726|141336674|SUPERIORITY||Differences of percentages|-5.6||||0.838|TWO_SIDED|90.0|-17.7|6.7||1-sided p-value is for comparison of ASP8062 30 mg with placebo using Fisher's Exact method.|Fisher Exact|||EOT: Differences of the percentages were calculated by subtracting the percentage of placebo group from the percentage of ASP8062 30 mg group. Confidence Interval (CI) for each treatment group and the difference of the percentages was an exact unconditional confidence interval based on Santner-Snell approach.||6.7|-17.7|0.838
70922791|NCT03092726|141336675|SUPERIORITY||Differences of percentages|2.2||||0.412|TWO_SIDED|90.0|-10.0|14.4||1-sided p-value is for comparison of ASP8062 30 mg with placebo using Fisher's Exact method.|Fisher Exact|||Week 8: Differences of the percentages were calculated by subtracting the percentage of placebo group from the percentage of ASP8062 30 mg group. Confidence Interval (CI) for each treatment group and the difference of the percentages was an exact unconditional confidence interval based on Santner-Snell approach.||14.4|-10.0|0.412
70922792|NCT03092726|141336675|SUPERIORITY||Differences of percentages|4.3||||0.269|TWO_SIDED|90.0|-7.9|16.4||1-sided p-value is for comparison of ASP8062 30 mg with placebo using Fisher's Exact method.|Fisher Exact|||EOT: Differences of the percentages were calculated by subtracting the percentage of placebo group from the percentage of ASP8062 30 mg group. Confidence Interval (CI) for each treatment group and the difference of the percentages was an exact unconditional confidence interval based on Santner-Snell approach.||16.4|-7.9|0.269
70922793|NCT03092726|141336676|SUPERIORITY||LSM Difference|-0.68|STANDARD_ERROR_OF_MEAN|2.03||0.369|TWO_SIDED|90.0|-4.05|2.68||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 2: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||2.68|-4.05|0.369
70922794|NCT03092726|141336676|SUPERIORITY||LSM Difference|-0.64|STANDARD_ERROR_OF_MEAN|2.34||0.393|TWO_SIDED|90.0|-4.51|3.24||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 4: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||3.24|-4.51|0.393
70922795|NCT03092726|141336676|SUPERIORITY||LSM Difference|0.86|STANDARD_ERROR_OF_MEAN|2.68||0.626|TWO_SIDED|90.0|-3.57|5.3|||MMRM|||Week 8: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||5.30|-3.57|0.626
70922796|NCT03092726|141336676|SUPERIORITY||LSM Difference|1.09|STANDARD_ERROR_OF_MEAN|2.57||0.664|TWO_SIDED|90.0|-3.16|5.34||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described ANCOVA model.|ANCOVA|||EOT: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using an ANCOVA model that was performed with change from baseline at the EOT timepoint as response, treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.||5.34|-3.16|0.664
70922797|NCT03092726|141336677|SUPERIORITY||LSM Difference|0.16|STANDARD_ERROR_OF_MEAN|1.85||0.534|TWO_SIDED|90.0|-2.9|3.22||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 2: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||3.22|-2.90|0.534
71008535|NCT02140762|141525115|OTHER|For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].|Vaccine Effectiveness|19.1|||||TWO_SIDED|||||||||Vaccine effectiveness\<30%||||
71035769|NCT04667338|141580453|SUPERIORITY||||||=|0.0531|||||||t-test, 2 sided|||||||=0.0531
71035770|NCT04667338|141580454|SUPERIORITY||||||=|0.0005|||||||Chi-squared|||Take short naps||||=0.0005
71035771|NCT04667338|141580454|SUPERIORITY||||||=|0.8221|||||||Chi-squared|||Maintain a regular sleep schedule||||=0.8221
71035772|NCT04667338|141580454|SUPERIORITY||||||=|0.2291|||||||Chi-squared|||Avoid caffeine or alcohol before bedtime||||=0.2291
71035773|NCT04667338|141580454|SUPERIORITY||||||=|0.9177|||||||Chi-squared|||Avoid smoking, especially at night||||=0.9177
71035774|NCT04667338|141580454|SUPERIORITY||||||=|0.4188|||||||Chi-squared|||Exercise daily||||=0.4188
71035775|NCT04667338|141580454|SUPERIORITY||||||=|0.5818|||||||Chi-squared|||Avoid large, heavy meals right before bedtime||||=0.5818
71035776|NCT04667338|141580454|SUPERIORITY||||||=|0.5432|||||||Chi-squared|||Other||||=0.5432
71035777|NCT04667338|141580455|SUPERIORITY||||||=|0.5432|||||||Chi-squared|||Treatment||||=0.5432
71035778|NCT04667338|141580455|SUPERIORITY||||||=|0.0397|||||||Chi-squared|||Routine monitoring visits||||=0.0397
70981336|NCT02799381|141470378|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|-4.05|||=|0.0762|TWO_SIDED|95.0|-8.55|0.44||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|If the primary efficacy variable was statistically significant, each of the secondary variables were to be tested using a fixed sequence as a gatekeeping procedure and at α level of 0.050. Testing was to cease at the point that a secondary variable failed to demonstrate statistical significance.||0.44|-8.55|=0.0762
70981337|NCT03952130|141470385|NON_INFERIORITY|Noninferiority margin = 0.4% for HbA1c|LS Mean Difference|0.07|||||TWO_SIDED|95.0|-0.11|0.24||||||||0.24|-0.11|
70981338|NCT03952130|141470386|SUPERIORITY||LS Mean Difference|-17.8||||0.003|TWO_SIDED|95.0|-29.4|-6.1|||ANCOVA|||||-6.1|-29.4|0.003
70981339|NCT03952130|141470387|SUPERIORITY||LS Mean Difference|-25.5||||0.001|TWO_SIDED|95.0|-41.1|-10.0|||ANCOVA|||||-10.0|-41.1|0.001
70981340|NCT03952130|141470388|OTHER||Relative rate|0.85||||0.834|TWO_SIDED|95.0|0.19|3.77|||Empirical method|||||3.77|0.19|0.834
70981341|NCT03952130|141470389|OTHER||Relative rate|1.0||||0.983|TWO_SIDED|95.0|0.72|1.38|||Negative binomial regression|||\<=30 minutes post meal||1.38|0.72|0.983
70981342|NCT03952130|141470389|OTHER||Relative rate|1.61||||0.076|TWO_SIDED|95.0|0.95|2.74|||Negative binomial regression|||\<=1 hour post meal||2.74|0.95|0.076
70981343|NCT03952130|141470389|OTHER||Relative rate|1.19||||0.409|TWO_SIDED|95.0|0.79|1.79|||Negative binomial regression|||\<=2 hours post meal||1.79|0.79|0.409
70981344|NCT03952130|141470389|OTHER||Relative rate|1.22||||0.217|TWO_SIDED|95.0|0.89|1.68|||Negative binomial regression|||\<=4 hours post meal||1.68|0.89|0.217
70981345|NCT03952130|141470389|OTHER||Relative rate|1.09||||0.703|TWO_SIDED|95.0|0.71|1.65|||Negative binomial regression|||\>1 to \<=2 hours post meal||1.65|0.71|0.703
70981346|NCT03952130|141470389|OTHER||Relative rate|1.24||||0.206|TWO_SIDED|95.0|0.89|1.73|||Negative binomial regression|||\>2 to \<=4 hours post meal||1.73|0.89|0.206
70981347|NCT03952130|141470389|OTHER||Relative rate|0.75||||0.082|TWO_SIDED|95.0|0.55|1.04|||Negative binomial regression|||\>4 hours post meal||1.04|0.55|0.082
70981348|NCT03952130|141470390|OTHER||LS Mean Difference|-0.29||||0.309|TWO_SIDED|95.0|-0.86|0.27|||Mixed Models Analysis|||||0.27|-0.86|0.309
70981349|NCT03952130|141470391|OTHER||LS Mean Difference|-15.7|||<|0.001|TWO_SIDED|95.0|-23.8|-7.7|||Mixed Models Analysis|||Morning premeal-fasting||-7.7|-23.8|<.001
70981350|NCT03952130|141470391|OTHER||LS Mean Difference|-14.0||||0.005|TWO_SIDED|95.0|-23.8|-4.2|||Mixed Models Analysis|||Morning 1-hour post meal||-4.2|-23.8|0.005
70981351|NCT03952130|141470391|OTHER||LS Mean Difference|-14.9||||0.004|TWO_SIDED|95.0|-25.0|-4.8|||Mixed Models Analysis|||Morning 2-hour post meal||-4.8|-25.0|0.004
70981352|NCT03952130|141470391|OTHER||LS Mean Difference|-2.3||||0.616|TWO_SIDED|95.0|-11.4|6.8|||Mixed Models Analysis|||Midday premeal||6.8|-11.4|0.616
70981353|NCT03952130|141470391|OTHER||LS Mean Difference|-9.1||||0.054|TWO_SIDED|95.0|-18.4|0.1|||Mixed Models Analysis|||Midday 1-hour post meal||0.1|-18.4|0.054
70981354|NCT03952130|141470391|OTHER||LS Mean Difference|-3.3||||0.483|TWO_SIDED|95.0|-12.6|6.0|||Mixed Models Analysis|||Midday 2-hour post meal||6.0|-12.6|0.483
70981355|NCT03952130|141470391|OTHER||LS Mean Difference|10.5||||0.064|TWO_SIDED|95.0|-0.6|21.7|||Mixed Models Analysis|||Evening premeal||21.7|-0.6|0.064
70981356|NCT03952130|141470391|OTHER||LS Mean Difference|-5.6||||0.262|TWO_SIDED|95.0|-15.5|4.2|||Mixed Models Analysis|||Evening 1-hour post meal||4.2|-15.5|0.262
70981357|NCT03952130|141470391|OTHER||LS Mean Difference|-7.8||||0.117|TWO_SIDED|95.0|-17.5|2.0|||Mixed Models Analysis|||Evening 2-hour post meal||2.0|-17.5|0.117
70981358|NCT03952130|141470391|OTHER||LS Mean Difference|-4.4||||0.414|TWO_SIDED|95.0|-15.1|6.2|||Mixed Models Analysis|||Bedtime||6.2|-15.1|0.414
70981359|NCT03952130|141470392|OTHER||LS Mean Difference|0.0||||0.947|TWO_SIDED|95.0|-0.7|0.6|||Mixed Models Analysis|||Basal insulin dose||0.6|-0.7|0.947
70981360|NCT03952130|141470392|OTHER||LS Mean Difference|0.7||||0.5|TWO_SIDED|95.0|-1.3|2.6|||Mixed Models Analysis|||Bolus insulin dose||2.6|-1.3|0.500
70981361|NCT03952130|141470392|OTHER||LS Mean Difference|0.6||||0.543|TWO_SIDED|95.0|-1.4|2.7|||Mixed Models Analysis|||Total insulin dose||2.7|-1.4|0.543
70981362|NCT03952130|141470393|OTHER||Odds Ratio (OR)|0.81||||0.462|TWO_SIDED|95.0|0.47|1.42|||Regression, Logistic|||For HbA1c \< 7%||1.42|0.47|0.462
70981363|NCT03952130|141470393|OTHER||Odds Ratio (OR)|0.54||||0.089|TWO_SIDED|95.0|0.26|1.1|||Regression, Logistic|||For HbA1c ≤6.5%||1.10|0.26|0.089
70981364|NCT01075087|141470432|SUPERIORITY_OR_OTHER||Median Difference (Net)|-5.5||||0.05|TWO_SIDED|90.0|-26.0|3.0|||Wilcoxon (Mann-Whitney)|||||3|-26|.05
70981365|NCT00283387|141470436|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|||||||0.007
70981366|NCT03584009|141470450|SUPERIORITY||Risk Difference (RD)|-1.96||||0.7286|TWO_SIDED|95.0|-16.86|12.94||P-value is based on Stratified Analysis (Stratified by BCL2 status (High vs Low) and Lines of Therapy (2 vs 1)).|Cochran-Mantel-Haenszel|||||12.94|-16.86|0.7286
70981367|NCT03584009|141470451|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.7853|TWO_SIDED|95.0|0.61|1.45||P-value is based on Stratified Analysis (Stratified by BCL2 status (High vs Low) and Lines of Therapy (2 vs 1)).|Regression, Cox|||||1.45|0.61|0.7853
70981368|NCT03584009|141470452|SUPERIORITY||Risk Difference (RD)|-1.96||||0.5978|TWO_SIDED|95.0|-12.29|8.37||P-value is based on Stratified Analysis (Stratified by BCL2 status (High vs Low) and Lines of Therapy (2 vs 1)).|Cochran-Mantel-Haenszel|||||8.37|-12.29|0.5978
70981369|NCT03584009|141470454|SUPERIORITY||Hazard Ratio (HR)|1.87||||0.0403|TWO_SIDED|95.0|1.02|3.43||P-value is based on Stratified Analysis (Stratified by BCL2 status (High vs Low) and Lines of Therapy (2 vs 1)).|Log Rank||Hazard ratios were estimated by Cox regression.|||3.43|1.02|0.0403
70981370|NCT02886715|141470468|EQUIVALENCE|90% Confidence Interval for the least-squares mean Test/Reference ratios to be within 80-125%|Test-to-Reference Ratio|98.75|||||TWO_SIDED|90.0|94.39|103.31||p-value was no calculated|ANOVA|with treatment and site as fixed effects in the model||||103.31|94.39|
71035779|NCT04667338|141580455|SUPERIORITY||||||=|0.0306|||||||Chi-squared|||Tests||||=0.0306
71035780|NCT04667338|141580455|SUPERIORITY||||||=|0.7451|||||||Chi-squared|||Emergency visits||||=0.7451
71035781|NCT04667338|141580455|SUPERIORITY||||||=|0.0845|||||||Chi-squared|||Hospitalizations||||=0.0845
70981371|NCT02886715|141470468|SUPERIORITY||Mean Difference (Final Values)|-5.17||||0.0185|TWO_SIDED|95.0|-9.46|-0.87|||ANOVA|with treatment and site as fixed effects in the model||||-0.87|-9.46|0.0185
70922798|NCT03092726|141336677|SUPERIORITY||LSM Difference|1.46|STANDARD_ERROR_OF_MEAN|2.08||0.758|TWO_SIDED|90.0|-1.98|4.91||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 4: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||4.91|-1.98|0.758
70922799|NCT03092726|141336677|SUPERIORITY||LSM Difference|1.7|STANDARD_ERROR_OF_MEAN|2.57||0.745|TWO_SIDED|90.0|-2.56|5.96||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 8: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||5.96|-2.56|0.745
70922800|NCT03092726|141336677|SUPERIORITY||LSM Difference|1.68|STANDARD_ERROR_OF_MEAN|2.43||0.755|TWO_SIDED|90.0|-2.34|5.69||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described ANCOVA model.|ANCOVA|||EOT: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using an ANCOVA model that was performed with change from baseline at the EOT timepoint as response, treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.||5.69|-2.34|0.755
70922801|NCT03092726|141336678|SUPERIORITY||LSM Difference|0.19|STANDARD_ERROR_OF_MEAN|0.59||0.629|TWO_SIDED|90.0|-0.78|1.17||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 2: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||1.17|-0.78|0.629
70922802|NCT03092726|141336678|SUPERIORITY||LSM Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.73||0.41|TWO_SIDED|90.0|-1.37|1.04||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 4: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||1.04|-1.37|0.410
70922803|NCT03092726|141336678|SUPERIORITY||LSM Difference|0.06|STANDARD_ERROR_OF_MEAN|0.71||0.531|TWO_SIDED|90.0|-1.11|1.22||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 8: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||1.22|-1.11|0.531
70922804|NCT03092726|141336678|SUPERIORITY||LSM Difference|0.17|STANDARD_ERROR_OF_MEAN|0.67||0.603|TWO_SIDED|90.0|-0.93|1.28||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described ANCOVA model.|ANCOVA|||EOT: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using an ANCOVA model that was performed with change from baseline at the EOT timepoint as response, treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.||1.28|-0.93|0.603
70922805|NCT03092726|141336679|SUPERIORITY||Odds Ratio (OR)|1.07||||0.811|TWO_SIDED|90.0|0.68|1.67||2-sided p-value is for the comparison of ASP8062 30 mg with placebo from the above described proportional odds model.|Proportional Odds model|||Week 2: Odds ratio of ASP8062 30 mg versus placebo, associated 90% 2-sided CI and p-value was estimated using a proportional odds model including treatment group as a factor.||1.67|0.68|0.811
70922806|NCT03092726|141336679|SUPERIORITY||Odds Ratio (OR)|0.79||||0.368|TWO_SIDED|90.0|0.5|1.22||2-sided p-value is for the comparison of ASP8062 30 mg with placebo from the above described proportional odds model.|Proportional Odds model|||Week 4: Odds ratio of ASP8062 30 mg versus placebo, associated 90% 2-sided CI and p-value was estimated using a proportional odds model including treatment group as a factor.||1.22|0.50|0.368
70922807|NCT03092726|141336679|SUPERIORITY||Odds Ratio (OR)|0.78||||0.357|TWO_SIDED|90.0|0.5|1.21||2-sided p-value is for the comparison of ASP8062 30 mg with placebo from the above described proportional odds model.|Proportional Odds model|||Week 8: Odds ratio of ASP8062 30 mg versus placebo, associated 90% 2-sided CI and p-value was estimated using a proportional odds model including treatment group as a factor.||1.21|0.50|0.357
70922808|NCT03092726|141336679|SUPERIORITY||Odds Ratio (OR)|0.8||||0.407|TWO_SIDED|90.0|0.52|1.24||2-sided p-value is for the comparison of ASP8062 30 mg with placebo from the above described proportional odds model.|Proportional Odds model|||EOT: Odds ratio of ASP8062 30 mg versus placebo, associated 90% 2-sided CI and p-value was estimated using a proportional odds model including treatment group as a factor.||1.24|0.52|0.407
70922809|NCT04950127|141336680|SUPERIORITY||Mean Difference (Net)|-0.72||||0.001|TWO_SIDED|95.0|-1.15|-0.28|||Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline Monthly Itch score (MIS), Visit\*Baseline MIS interaction, Baseline Concomitant Itch Medication.||-0.28|-1.15|0.001
70922810|NCT04950127|141336681|SUPERIORITY||Mean Difference (Net)|-0.71|||<|0.001|TWO_SIDED|95.0|-1.07|-0.34||Adjusted for multiplicity as per Statistical Analysis Plan (SAP)|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Week, Week\*Treatment Group interaction, Baseline Weekly Itch score (WIS), Visit\*Baseline WIS interaction, Baseline Concomitant Itch Medication.||-0.34|-1.07|<0.001
71035782|NCT04667338|141580455|SUPERIORITY||||||=|0.3813|||||||Chi-squared|||Complications||||=0.3813
71035783|NCT04667338|141580457|SUPERIORITY||||||=|0.0034|||||||t-test, 2 sided|||Absenteeism||||=0.0034
71035784|NCT04667338|141580457|SUPERIORITY||||||=|0.2178|||||||t-test, 2 sided|||Presenteeism||||=0.2178
71096924|NCT03467945|141702934|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|93.6828|||||TWO_SIDED|90.0|88.6166|99.0386||||||||99.0386|88.6166|
71096925|NCT03467945|141702934|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|115.37|||||TWO_SIDED|90.0|109.131|121.9658||||||||121.9658|109.1310|
71096926|NCT03467945|141702935|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|82.6022|||||TWO_SIDED|90.0|76.5513|89.1314||||||||89.1314|76.5513|
70981372|NCT02886715|141470470|EQUIVALENCE|90% Confidence Interval for the least-squares mean Test/Reference ratios to be within 80-125%|Test-to-Reference Ratio|98.39|||||TWO_SIDED|90.0|93.42|103.61||p-value was no calculated|ANOVA|with treatment and site as fixed effects in the model||||103.61|93.42|
70981373|NCT02886715|141470470|SUPERIORITY||Mean Difference (Final Values)|-4.39||||0.0354|TWO_SIDED|95.0|-8.48|-0.3|||ANOVA|with treatment and site as fixed effects in the model||||-0.30|-8.48|0.0354
71096927|NCT03467945|141702935|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|101.8499|||||TWO_SIDED|90.0|97.8819|106.9028||||||||106.9028|97.8819|
70981374|NCT01073943|141470491|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the 1-sided 97.5% CI for the treatment difference (PICOPREP minus HalfLytely) was \>-9% for the percentage of responders. Superiority was demonstrated if the 1-sided 97.5% CI for treatment difference was \>0%.|Mean Difference (Net)|3.3|||||ONE_SIDED|97.5|-2.9||||||||||-2.9|
70981375|NCT01073943|141470492|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|-2.7|||||ONE_SIDED|97.5|-8.8||||||||||-8.8|
71096928|NCT03467945|141702935|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|81.0112|||||TWO_SIDED|90.0|74.8823|87.6417||||||||87.6417|74.8823|
71096929|NCT03467945|141702936|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|101.8499|||||TWO_SIDED|90.0|97.5947|106.2906||||||||106.2906|97.5947|
70981376|NCT01073943|141470493|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
70981377|NCT01073943|141470494|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
70981378|NCT01073943|141470495|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71096930|NCT03467945|141702936|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|105.915|||||TWO_SIDED|90.0|101.49|110.533||||||||110.5330|101.4900|
71096931|NCT03467945|141702936|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|96.1619|||||TWO_SIDED|90.0|92.1443|100.3546||||||||100.3546|92.1443|
71096932|NCT02187055|141702956|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was a treatment difference larger than -13% at the population level|Difference in response rate|-7.73||||0.2101|TWO_SIDED|98.34|-16.29|0.83|||Normal approximation to proportions|Multiplicity-adjusted||||0.83|-16.29|0.2101
71096933|NCT02187055|141702956|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was a treatment difference larger than -13% at the population level|Difference in response rate|-5.5||||0.0512|TWO_SIDED|98.34|-13.98|2.98|||Normal approximation to proportions|Multiplicity-adjusted||||2.98|-13.98|0.0512
71096934|NCT02187055|141702956|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was a treatment difference larger than -13% at the population level|Difference in response rate|2.23|||<|0.0001|TWO_SIDED|98.34|-6.4|10.86|||Normal approximation to proportions|Multiplicity adjusted||||10.86|-6.40|<0.0001
71096935|NCT02187055|141702957|SUPERIORITY_OR_OTHER||LS mean difference|2.8|||||TWO_SIDED|95.0|1.23|4.41||||||||4.41|1.23|
71096936|NCT02187055|141702957|SUPERIORITY_OR_OTHER||LS mean difference|1.9|||||TWO_SIDED|95.0|0.33|3.49||||||||3.49|0.33|
71096937|NCT02187055|141702957|SUPERIORITY_OR_OTHER||LS mean difference|-0.9|||||TWO_SIDED|95.0|-2.51|0.68||||||||0.68|-2.51|
71096938|NCT02187055|141702958|SUPERIORITY_OR_OTHER||LS mean difference|2.6|||||TWO_SIDED|95.0|1.08|4.18||||||||4.18|1.08|
71096939|NCT02187055|141702958|SUPERIORITY_OR_OTHER||LS mean difference|1.9|||||TWO_SIDED|95.0|0.4|3.48||||||||3.48|0.40|
70981379|NCT01073943|141470496|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
70981380|NCT01073943|141470497|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
70981381|NCT01073943|141470498|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
70981382|NCT01073943|141470500|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|4.5|||||ONE_SIDED|97.5|-0.1|||||||Mid colon comparison|||-0.1|
70981383|NCT01073943|141470500|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|3.2|||||ONE_SIDED|97.5|-1.5|||||||Recto-sigmoid colon comparison|||-1.5|
70981384|NCT01073943|141470500|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|0.9|||||ONE_SIDED|97.5|-5.7|||||||Overall comparison: ascending colon, mid colon and recto-sigmoid colon|||-5.7|
70981385|NCT03830281|141470516|NON_INFERIORITY|Noninferiority margin = 0.4% for HbA1c|Mean Difference (Final Values)|0.02||||0.565|TWO_SIDED|95.0|-0.06|0.11|||Mixed Models Analysis|||||0.11|-0.06|0.565
71096940|NCT02187055|141702958|SUPERIORITY_OR_OTHER||LS mean difference|-0.7|||||TWO_SIDED|95.0|-2.24|0.86||||||||0.86|-2.24|
71096941|NCT02187055|141702959|SUPERIORITY_OR_OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|0.16|0.5||||||||0.50|0.16|
71096942|NCT02187055|141702959|SUPERIORITY_OR_OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|0.05|0.39||||||||0.39|0.05|
70981386|NCT03830281|141470517|SUPERIORITY||LS Mean Difference|-24.1|||<|0.001|TWO_SIDED|95.0|-36.0|-12.2|||ANCOVA|||||-12.2|-36.0|<0.001
70981387|NCT03830281|141470518|SUPERIORITY||LS Mean Difference|-27.8|||<|0.001|TWO_SIDED|95.0|-42.6|-13.0|||ANCOVA|||||-13.0|-42.6|< 0.001
70981388|NCT03830281|141470519|SUPERIORITY||LS Mean Difference|0.7||||0.532|TWO_SIDED|95.0|-1.4|2.8|||Mixed Models Analysis|||Statistical analysis during daytime is reported.||2.8|-1.4|0.532
70981389|NCT03830281|141470519|SUPERIORITY||LS Mean Difference|0.4||||0.738|TWO_SIDED|95.0|-1.8|2.5|||Mixed Models Analysis|||Statistical analysis during 24-hour period is reported.||2.5|-1.8|0.738
70981390|NCT02201940|141470536|SUPERIORITY_OR_OTHER||||||<|0.001||||||Participants in the SOF/VEL group were compared to the performance goal of 85% using a 2-sided exact 1-sample binomial test at the 0.05 significance level.|Binomial test|||||||< 0.001
70981391|NCT03192904|141470542|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
70981392|NCT01309737|141470557|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.2|||<|0.0001|TWO_SIDED|95.0|5.33|17.68||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||17.68|5.33|<0.0001
70981393|NCT01309737|141470557|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.43|||<|0.0001|TWO_SIDED|95.0|8.99|30.59||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||30.59|8.99|<0.0001
70981394|NCT01309737|141470557|SUPERIORITY_OR_OTHER||Percent difference|13.08|STANDARD_ERROR_OF_MEAN|3.62||0.0003|TWO_SIDED|95.0|5.99|20.17|||Normal approximation|||||20.17|5.99|0.0003
70981395|NCT01309737|141470558|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-45.73|STANDARD_ERROR_OF_MEAN|3.69|<|0.0001|TWO_SIDED|95.0|-52.98|-38.49||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error.Sequential order of testing: percent change in BSA at Week 16,PASI90 response at Week 16, change in Dermatology Life Quality Index(DLQI) total score at Week 16,PGA response at Week 4,PASI75 at Week 4, change in DLQI total score at Week 4, percent change in Nail Psoriasis Severity Index(NAPSI) score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-38.49|-52.98|<0.0001
70981396|NCT01309737|141470558|SUPERIORITY_OR_OTHER||LS Mean Difference|-58.1|STANDARD_ERROR_OF_MEAN|3.69|<|0.0001|TWO_SIDED|95.0|-65.33|-50.86||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error.Sequential order of testing: percent change in BSA at Week 16,PASI90 response at Week 16, change in Dermatology Life Quality Index(DLQI) total score at Week 16,PGA response at Week 4,PASI75 at Week 4, change in DLQI total score at Week 4, percent change in Nail Psoriasis Severity Index(NAPSI) score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-50.86|-65.33|<0.0001
70981397|NCT01309737|141470558|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.36|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|-18.24|-6.48|||Mixed Models Analysis|||LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-6.48|-18.24|<0.0001
71035785|NCT04667338|141580457|SUPERIORITY||||||=|0.1758|||||||t-test, 2 sided|||Work productivity loss||||=0.1758
71035786|NCT04667338|141580457|SUPERIORITY||||||=|0.1789|||||||t-test, 2 sided|||Activity Impairment / disability||||=0.1789
71035787|NCT04667338|141580458|SUPERIORITY||||||=|0.5806|||||||Chi-squared|||||||=0.5806
71035788|NCT04667338|141580460|SUPERIORITY||||||=|0.1602|||||||Chi-squared|||Mobility||||=0.1602
71035789|NCT04667338|141580460|SUPERIORITY||||||=|0.5249|||||||Chi-squared|||Self-Care||||=0.5249
71035790|NCT04667338|141580460|SUPERIORITY||||||=|0.1095|||||||Chi-squared|||Usual activities||||=0.1095
71035791|NCT04667338|141580460|SUPERIORITY||||||=|0.3528|||||||Chi-squared|||Pain / Discomfort||||=0.3528
71035792|NCT04667338|141580460|SUPERIORITY||||||=|0.7434|||||||Chi-squared|||Anxiety / Depression||||=0.7434
71035793|NCT04667338|141580461|SUPERIORITY||||||=|0.0396|||||||t-test, 2 sided|||||||=0.0396
71035794|NCT04667338|141580462|SUPERIORITY||||||=|0.0394|||||||t-test, 2 sided|||Effectiveness||||=0.0394
71035795|NCT04667338|141580462|SUPERIORITY||||||=|0.3093|||||||t-test, 2 sided|||Convenience||||=0.3093
71035796|NCT04667338|141580462|SUPERIORITY||||||=|0.2296|||||||t-test, 2 sided|||Global satisfaction||||=0.2296
71035797|NCT04667338|141580463|SUPERIORITY||||||=|0.1817|||||||Chi-squared|||Depression||||=0.1817
71035798|NCT04667338|141580463|SUPERIORITY||||||=|0.0885|||||||Chi-squared|||Bipolar disorder||||=0.0885
71035799|NCT04667338|141580463|SUPERIORITY||||||=|0.3043|||||||Chi-squared|||Anxiety disorders||||=0.3043
71035800|NCT04667338|141580463|SUPERIORITY||||||=|0.0885|||||||Chi-squared|||Panic disorder||||=0.0885
71035801|NCT04667338|141580463|SUPERIORITY||||||=|0.5603|||||||Chi-squared|||Phobia disorder||||=0.5603
71035802|NCT04667338|141580463|SUPERIORITY||||||=|0.5603|||||||Chi-squared|||Obsessive compulsive disorder||||=0.5603
71035803|NCT04667338|141580463|SUPERIORITY||||||=|0.3646|||||||Chi-squared|||Diagnosis of ADHD||||=0.3646
71035804|NCT04667338|141580463|SUPERIORITY||||||=|0.2615|||||||Chi-squared|||Obesity||||=0.2615
70981398|NCT01309737|141470559|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.5|||<|0.0001||95.0|3.48|17.31||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||17.31|3.48|<0.0001
70981399|NCT01309737|141470559|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.53|||<|0.0001|TWO_SIDED|95.0|8.08|46.22||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||46.22|8.08|<0.0001
70981400|NCT01309737|141470559|SUPERIORITY_OR_OTHER||Percent Difference|14.3|STANDARD_ERROR_OF_MEAN|3.36|<|0.0001|TWO_SIDED|95.0|7.72|20.88|||Normal Approximation|||||20.88|7.72|<0.0001
70981401|NCT01309737|141470561|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.97|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001||95.0|-3.8|-2.14||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week4: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-2.14|-3.80|<0.0001
70981402|NCT01309737|141470561|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-5.13|-3.47||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 4: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-3.47|-5.13|<0.0001
70981403|NCT01309737|141470561|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|0.35||0.0001|TWO_SIDED|95.0|-2.01|-0.65|||Mixed Models Analysis|||Week 4: LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-0.65|-2.01|0.0001
70981404|NCT01309737|141470561|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.46|STANDARD_ERROR_OF_MEAN|0.53|<|0.0001|TWO_SIDED|95.0|-5.51|-3.42||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 16: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-3.42|-5.51|<0.0001
70981405|NCT01309737|141470561|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|0.53|<|0.0001|TWO_SIDED|95.0|-7.14|-5.05||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 16: For key secondary endpoint, family-wise step-down procedure was used to control Type I error.Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-5.05|-7.14|<0.0001
70981406|NCT01309737|141470561|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.63|STANDARD_ERROR_OF_MEAN|0.43||0.0002|TWO_SIDED|95.0|-2.48|-0.79|||Mixed Models Analysis|||Week 16: LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-0.79|-2.48|0.0002
71035805|NCT04667338|141580463|SUPERIORITY||||||=|0.3076|||||||Chi-squared|||Endocrine Disorders||||=0.3076
71035806|NCT04667338|141580463|SUPERIORITY||||||=|0.409|||||||Chi-squared|||Peripheral vascular disease||||=0.4090
71035807|NCT04667338|141580463|SUPERIORITY||||||=|0.5603|||||||Chi-squared|||Cardiovascular accident or transient ischemic attack (TIA)||||=0.5603
71035808|NCT04667338|141580463|SUPERIORITY||||||=|0.5603|||||||Chi-squared|||COPD||||=0.5603
71035809|NCT04667338|141580463|SUPERIORITY||||||=|0.5603|||||||Chi-squared|||Connective tissue disease||||=0.5603
71035810|NCT04667338|141580463|SUPERIORITY||||||=|0.7451|||||||Chi-squared|||Liver Disease||||=0.7451
71035811|NCT04667338|141580463|SUPERIORITY||||||=|0.3108|||||||Chi-squared|||Diabetes Mellitus||||=0.3108
71035812|NCT04667338|141580463|SUPERIORITY||||||=|0.2407|||||||Chi-squared|||Solid Tumor||||=0.2407
71035813|NCT04667338|141580463|SUPERIORITY||||||=|0.5603|||||||Chi-squared|||AIDS||||=0.5603
71035814|NCT04667338|141580463|SUPERIORITY||||||=|0.1739|||||||Chi-squared|||Others||||=0.1739
71035815|NCT04667338|141580464|SUPERIORITY||||||=|0.3585|||||||t-test, 2 sided|||||||=0.3585
71035816|NCT03488108|141580474|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||.009
71035817|NCT03488108|141580475|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||.90
70981407|NCT01309737|141470562|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.63|||<|0.0001|TWO_SIDED|95.0|1.89|8.95||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||8.95|1.89|<.0001
71096943|NCT02187055|141702959|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-0.28|0.06||||||||0.06|-0.28|
70981408|NCT01309737|141470562|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.25|||<|0.0001|TWO_SIDED|95.0|4.08|19.95||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||19.95|4.08|<.0001
70981409|NCT01309737|141470562|SUPERIORITY_OR_OTHER||Percent difference|10.79|STANDARD_ERROR_OF_MEAN|3.02||0.0004|TWO_SIDED|95.0|4.87|16.71|||Normal Approximation|||||16.71|4.87|0.0004
70981410|NCT01309737|141470563|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72||||0.1786|TWO_SIDED|95.0|0.74|4.62||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||4.62|0.74|0.1786
70981411|NCT01309737|141470563|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.18||||0.0003|TWO_SIDED|95.0|1.77|10.25||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error.Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||10.25|1.77|0.0003
70981412|NCT01309737|141470563|SUPERIORITY_OR_OTHER||Percent Difference|6.72|STANDARD_ERROR_OF_MEAN|2.26||0.0029|TWO_SIDED|95.0|2.3|11.14|||Normal Approximation|||||11.14|2.30|0.0029
70981413|NCT01309737|141470564|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.06|||<|0.0001|TWO_SIDED|95.0|5.02|16.45||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||16.45|5.02|<0.0001
70981414|NCT01309737|141470564|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.97|||<|0.0001||95.0|9.0|30.73||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||30.73|9.00|<0.0001
70981415|NCT01309737|141470564|SUPERIORITY_OR_OTHER||Percent difference|13.62||||0.0002|TWO_SIDED|95.0|6.54|20.69|||Normal Approximation|||||20.69|6.54|0.0002
70981416|NCT01309737|141470565|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.44|STANDARD_ERROR_OF_MEAN|13.62||0.0062|TWO_SIDED|95.0|-64.19|-10.68||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-10.68|-64.19|0.0062
71008777|NCT02055976|141525253|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-57.576|STANDARD_ERROR_OF_MEAN|3.544|<|0.001|TWO_SIDED|95.0|-64.618|-50.533|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-50.533|-64.618|<0.001
71096944|NCT02187055|141702960|SUPERIORITY_OR_OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|0.15|0.51||||||||0.51|0.15|
71096945|NCT02187055|141702960|SUPERIORITY_OR_OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|0.1|0.46||||||||0.46|0.10|
71096946|NCT02187055|141702960|SUPERIORITY_OR_OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.23|0.13||||||||0.13|-0.23|
71096947|NCT02187055|141702961|SUPERIORITY_OR_OTHER||Difference in remission rate|-1.21|||||TWO_SIDED|95.0|-4.99|2.56||||||||2.56|-4.99|
71096948|NCT02187055|141702961|SUPERIORITY_OR_OTHER||Difference in remission rate|-1.78|||||TWO_SIDED|95.0|-5.59|2.04||||||||2.04|-5.59|
71096949|NCT02187055|141702961|SUPERIORITY_OR_OTHER||Difference in remission rate|-0.56|||||TWO_SIDED|95.0|-4.53|3.4||||||||3.40|-4.53|
70981417|NCT01309737|141470565|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.79|STANDARD_ERROR_OF_MEAN|13.75||0.0025|TWO_SIDED|95.0|-68.8|-14.78||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-14.78|-68.80|0.0025
70981418|NCT01309737|141470565|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.35|STANDARD_ERROR_OF_MEAN|10.98||0.692|TWO_SIDED|95.0|-25.91|17.21|||Mixed Models Analysis|||LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||17.21|-25.91|0.6920
70981419|NCT01309737|141470569|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
70981420|NCT01309737|141470569|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
70981421|NCT01309737|141470569|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71096950|NCT02187055|141702962|SUPERIORITY_OR_OTHER||Difference in remission rate|-3.4|||||TWO_SIDED|95.0|-7.95|1.15||||||||1.15|-7.95|
70981422|NCT01309737|141470570|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
70981423|NCT01309737|141470570|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
70981424|NCT01309737|141470570|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
70981425|NCT01309737|141470571|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
70981426|NCT01309737|141470571|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
70981427|NCT01309737|141470571|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
70981428|NCT04996797|141470643|SUPERIORITY||Risk Difference (RD)|25.0|||<|0.0001|TWO_SIDED|95.0|11.8|36.5|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||36.5|11.8|<.0001
70981429|NCT04996797|141470646|SUPERIORITY||Risk Difference (RD)|30.8|||<|0.0001|TWO_SIDED|95.0|17.4|43.2|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||43.2|17.4|<0.0001
70981430|NCT04996797|141470647|SUPERIORITY||Risk Difference (RD)|43.8|||<|0.0001|TWO_SIDED|95.0|27.4|56.9|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||56.9|27.4|<.0001
70981431|NCT04996797|141470648|SUPERIORITY||Risk Difference (RD)|20.8||||0.0224||95.0|2.1|37.9|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factor of biologic status.|95% CI is estimated using Newcombe method for risk difference.|||37.9|2.1|0.0224
70981432|NCT04996797|141470649|SUPERIORITY||Risk Difference (RD)|13.1||||0.0223||95.0|1.8|24.6|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||24.6|1.8|0.0223
70981433|NCT04996797|141470650|SUPERIORITY||Risk Difference (RD)|28.6||||0.0009||95.0|12.1|42.9|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||42.9|12.1|0.0009
70981434|NCT04996797|141470651|SUPERIORITY||Risk Difference (RD)|27.3|||<|0.0001||95.0|14.3|39.6|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||39.6|14.3|<0.0001
70981435|NCT04996797|141470652|SUPERIORITY||Risk Difference (RD)|17.9||||||95.0|-2.4|36.4|||||95% CI is estimated using Newcombe method for risk difference.|||36.4|-2.4|
70981436|NCT04996797|141470653|SUPERIORITY||Risk Difference (RD)|22.8||||||95.0|0.4|42.2|||||95% CI is estimated using Newcombe method for risk difference.|||42.2|0.4|
71096951|NCT02187055|141702962|SUPERIORITY_OR_OTHER||Difference in remission rate|-3.06|||||TWO_SIDED|95.0|-7.55|1.43||||||||1.43|-7.55|
70981437|NCT04996797|141470654|SUPERIORITY||Risk Difference (RD)|10.2||||||95.0|-6.9|26.9|||||95% CI is estimated using Newcombe method for risk difference.|||26.9|-6.9|
70981438|NCT04996797|141470655|SUPERIORITY||Risk Difference (RD)|28.9||||||95.0|5.0|48.3|||||95% CI is estimated using Newcombe method for risk difference.|||48.3|5.0|
70981439|NCT04996797|141470656|SUPERIORITY||Risk Difference (RD)|22.2|||||TWO_SIDED|95.0|0.2|41.0|||||95% CI is estimated using Newcombe method for risk difference.|||41.0|0.2|
70981440|NCT04996797|141470657|SUPERIORITY||Risk Difference (RD)|27.3|||<|0.0001|TWO_SIDED|95.0|14.3|39.6|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||39.6|14.3|<0.0001
70981441|NCT04996797|141470658|SUPERIORITY||Risk Difference (RD)|22.2||||||95.0|0.2|41.0|||||95% CI is estimated using Newcombe method for risk difference.|||41.0|0.2|
71035818|NCT03488108|141580476|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||.003
71035819|NCT03488108|141580477|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||.005
71096952|NCT02187055|141702962|SUPERIORITY_OR_OTHER||Difference in remission rate|0.34|||||TWO_SIDED|95.0|-4.45|5.14||||||||5.14|-4.45|
70981442|NCT04996797|141470659|SUPERIORITY||Risk Difference (RD)|33.1|||<|0.0001||95.0|17.2|46.8|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||46.8|17.2|<0.0001
71096953|NCT02187055|141702963|SUPERIORITY_OR_OTHER||Difference in remission rate|-3.67|||||TWO_SIDED|95.0|-8.29|0.94||||||||0.94|-8.29|
70981443|NCT04996797|141470660|SUPERIORITY||Risk Difference (RD)|19.6||||||95.0|-1.7|38.7|||||95% CI is estimated using Newcombe method for risk difference.|||38.7|-1.7|
70981444|NCT05662332|141470668|NON_INFERIORITY|Noninferiority margin (NIM) was 0.4%|LS Mean Change difference|-0.03|||||TWO_SIDED|95.0|-0.18|0.12|||ANCOVA|||||0.12|-0.18|
70981445|NCT05662332|141470669|SUPERIORITY||LS Mean Change difference|-0.03||||0.684|TWO_SIDED|95.0|-0.18|0.12|||ANCOVA|||||0.12|-0.18|0.684
70981446|NCT05662332|141470670|SUPERIORITY||LS Mean Change difference|4.16||||0.155|TWO_SIDED|95.0|-1.58|9.9|||ANCOVA|||Week 52||9.90|-1.58|0.155
70981447|NCT05662332|141470671|SUPERIORITY||LS Mean Change difference|-43.7|||<|0.001|TWO_SIDED|95.0|-62.4|-25.0|||Mixed Models Analysis|||Week 52||-25.0|-62.4|<0.001
70981448|NCT05662332|141470672|SUPERIORITY||Relative Rate|0.57||||0.005|TWO_SIDED|95.0|0.39|0.84|||Negative binomial model|||||0.84|0.39|0.005
70981449|NCT05662332|141470674|SUPERIORITY||Relative Rate|0.58||||0.155|TWO_SIDED|95.0|0.28|1.23|||Negative binomial model|||||1.23|0.28|0.155
70981450|NCT05662332|141470676|SUPERIORITY||LS Mean difference (Final Values)|0.57||||0.033|TWO_SIDED|95.0|0.047|1.1|||Mixed Models Analysis|||||1.10|0.047|0.033
70981451|NCT05662332|141470677|SUPERIORITY||LS Mean difference (Final Values)|1.56||||0.071|TWO_SIDED|95.0|-0.13|3.25|||Mixed Models Analysis|||Week 52||3.25|-0.13|0.071
70981452|NCT05662332|141470680|SUPERIORITY||LS Mean difference (Final Values)|1.8||||0.072|TWO_SIDED|95.0|-0.2|3.8|||Mixed Models Analysis|||Week 52||3.8|-0.2|0.072
70981453|NCT01392183|141470689|SUPERIORITY||Hazard Ratio (HR)|1.36|||||TWO_SIDED|95.0|0.84|2.22|||||Adjusted Hazard Ratio comparing Median PFS of pazopanib (treatment group) to Temsirolimus (control group) as first line of treatment. HR \>1 treatment group performed better, \< 1 the control group performed better =1 groups performed equally.|||2.22|0.84|
71096954|NCT02187055|141702963|SUPERIORITY_OR_OTHER||Difference in remission rate|-3.06|||||TWO_SIDED|95.0|-7.59|1.48||||||||1.48|-7.59|
71096955|NCT02187055|141702963|SUPERIORITY_OR_OTHER||Difference in remission rate|0.62|||||TWO_SIDED|95.0|-4.24|5.47||||||||5.47|-4.24|
71096956|NCT02187055|141702964|SUPERIORITY_OR_OTHER||Difference in remission rate|-1.55|||||TWO_SIDED|95.0|-6.03|2.93||||||||2.93|-6.03|
70981454|NCT01392183|141470690|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.7|1.93|||||Adjusted HR comparing Median OS of pazopanib (treatment group) to Temsirolimus (control group) as first line of treatment. HR \>1 treatment group performed better, \< 1 the control group performed better =1 groups performed equally.|||1.93|0.7|
70981455|NCT03430310|141470691|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
70981456|NCT01446809|141470717|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
70981457|NCT01446809|141470718|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
70981458|NCT01212445|141470754|SUPERIORITY_OR_OTHER||Treatment Success Rate|0.192||||0.179|TWO_SIDED|95.0|0.096|0.325|||Fisher Exact|||The treatment success rate was defined as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).||0.325|0.096|0.1790
70981459|NCT01212445|141470754|SUPERIORITY_OR_OTHER||Treatment Success Rate|0.314||||1|TWO_SIDED|95.0|0.191|0.459|||Fisher Exact|||The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).||0.459|0.191|1.0000
70981460|NCT01212445|141470754|SUPERIORITY_OR_OTHER||Treatment Success Rate|0.196||||0.2558|TWO_SIDED|95.0|0.098|0.331|||Fisher Exact|||The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).||0.331|0.098|0.2558
70981461|NCT01212445|141470754|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92|||||TWO_SIDED|95.0|0.774|4.763|||Regression, Logistic|||"Logistic regression analysis was performed with treatment success as the dichotomous dependent variable and dose (13.125g, 26.25g, or 39.375 g) as the independent variable. The main effects for the model were tested for significance at the 5% level.~The odds of response for the 26.25 g dose level versus the 13.125 g dose level were presented together with the associated 95% confidence interval. There were no multiplicity adjustments."||4.763|0.774|
70981462|NCT01212445|141470754|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.024|||||TWO_SIDED|95.0|0.386|2.72|||Regression, Logistic|||"Logistic regression analysis was performed with treatment success as the dichotomous dependent variable and dose (13.125g, 26.25g, or 39.375 g) as the independent variable. The main effects for the model were tested for significance at the 5% level.~The odds of response for the 39.375 g dose level versus the 13.125 g dose level were presented together with the associated 95% confidence intervals. There were no multiplicity adjustments."||2.720|0.386|
70981463|NCT01212445|141470756|SUPERIORITY_OR_OTHER||Treatment Success Rate|0.077||||0.235|TWO_SIDED|95.0|0.021|0.185|||Fisher Exact|||The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).||0.185|0.021|0.2350
71096957|NCT02187055|141702964|SUPERIORITY_OR_OTHER||Difference in remission rate|-2.02|||||TWO_SIDED|95.0|-6.51|2.47||||||||2.47|-6.51|
71096958|NCT02187055|141702964|SUPERIORITY_OR_OTHER||Difference in remission rate|-0.47|||||TWO_SIDED|95.0|-5.11|4.18||||||||4.18|-5.11|
71096959|NCT02187055|141702965|SUPERIORITY_OR_OTHER||Difference in remission rate|-9.49|||||TWO_SIDED|95.0|-15.68|-3.3||||||||-3.30|-15.68|
71096960|NCT02187055|141702965|SUPERIORITY_OR_OTHER||Difference in remission rate|-6.89|||||TWO_SIDED|95.0|-12.94|-0.83||||||||-0.83|-12.94|
71096961|NCT02187055|141702965|SUPERIORITY_OR_OTHER||Difference in remission rate|2.61|||||TWO_SIDED|95.0|-3.86|9.07||||||||9.07|-3.86|
71096962|NCT02187055|141702966|SUPERIORITY_OR_OTHER||Difference in response rate|-6.24|||||TWO_SIDED|95.0|-13.32|0.84||||||||0.84|-13.32|
71096963|NCT02187055|141702966|SUPERIORITY_OR_OTHER||Difference in response rate|-3.66|||||TWO_SIDED|95.0|-10.69|3.37||||||||3.37|-10.69|
71096964|NCT02187055|141702966|SUPERIORITY_OR_OTHER||Difference in response rate|2.58|||||TWO_SIDED|95.0|-4.51|9.68||||||||9.68|-4.51|
71096965|NCT02187055|141702967|SUPERIORITY_OR_OTHER||Difference in response rate|-6.22|||||TWO_SIDED|95.0|-13.29|0.85||||||||0.85|-13.29|
71096966|NCT02187055|141702967|SUPERIORITY_OR_OTHER||Difference in response rate|-3.93|||||TWO_SIDED|95.0|-10.94|3.09||||||||3.09|-10.94|
71096967|NCT02187055|141702967|SUPERIORITY_OR_OTHER||Difference in response rate|2.3|||||TWO_SIDED|95.0|-4.79|9.39||||||||9.39|-4.79|
71096968|NCT02187055|141702968|SUPERIORITY_OR_OTHER||Difference in response rate|-6.02|||||TWO_SIDED|95.0|-12.05|0.0||||||||0.00|-12.05|
71096969|NCT02187055|141702968|SUPERIORITY_OR_OTHER||Difference in response rate|-6.89|||||TWO_SIDED|95.0|-12.9|-0.87||||||||-0.87|-12.90|
71096970|NCT02187055|141702968|SUPERIORITY_OR_OTHER||Difference in response rate|-0.87|||||TWO_SIDED|95.0|-7.17|5.44||||||||5.44|-7.17|
71096971|NCT02187055|141702969|SUPERIORITY_OR_OTHER||Difference in response rate|-4.87|||||TWO_SIDED|95.0|-11.92|2.18||||||||2.18|-11.92|
71096972|NCT02187055|141702969|SUPERIORITY_OR_OTHER||Difference in response rate|-5.48|||||TWO_SIDED|95.0|-12.49|1.52||||||||1.52|-12.49|
70981464|NCT01212445|141470756|SUPERIORITY_OR_OTHER||Treatment Success Rate|0.157||||0.5256|TWO_SIDED|95.0|0.07|0.286|||Fisher Exact|||The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).||0.286|0.070|0.5256
71008778|NCT02055976|141525253|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-37.991|STANDARD_ERROR_OF_MEAN|3.389|<|0.001|TWO_SIDED|95.0|-44.721|-31.26|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-31.260|-44.721|<0.001
71096973|NCT02187055|141702969|SUPERIORITY_OR_OTHER||Difference in rresponse rate|-0.61|||||TWO_SIDED|95.0|-7.7|6.47||||||||6.47|-7.70|
71096974|NCT02187055|141702970|SUPERIORITY_OR_OTHER||Difference in response rate|-8.29|||||TWO_SIDED|95.0|-14.84|-1.75||||||||-1.75|-14.84|
71096975|NCT02187055|141702970|SUPERIORITY_OR_OTHER||Difference in response rate|-6.14|||||TWO_SIDED|95.0|-12.72|0.44||||||||0.44|-12.72|
71096976|NCT02187055|141702970|SUPERIORITY_OR_OTHER||Difference in response rate|2.15|||||TWO_SIDED|95.0|-4.22|8.52||||||||8.52|-4.22|
71096977|NCT02187055|141702971|SUPERIORITY_OR_OTHER||Difference in response rate|-6.77|||||TWO_SIDED|95.0|-12.61|-0.93||||||||-0.93|-12.61|
71096978|NCT02187055|141702971|SUPERIORITY_OR_OTHER||Difference in response rate|-2.5|||||TWO_SIDED|95.0|-8.09|3.1||||||||3.10|-8.09|
71096979|NCT02187055|141702971|SUPERIORITY_OR_OTHER||Difference in response rate|4.27|||||TWO_SIDED|95.0|-1.68|10.23||||||||10.23|-1.68|
71096980|NCT02187055|141702972|SUPERIORITY_OR_OTHER||LS mean difference|0.07|||||TWO_SIDED|95.0|-0.011|0.148||||||||0.148|-0.011|
71096981|NCT02187055|141702972|SUPERIORITY_OR_OTHER||LS mean difference|0.03|||||TWO_SIDED|95.0|-0.054|0.105||||||||0.105|-0.054|
71096982|NCT02187055|141702972|SUPERIORITY_OR_OTHER||LS mean difference|-0.04|||||TWO_SIDED|95.0|-0.122|0.037||||||||0.037|-0.122|
71096983|NCT02187055|141702973|SUPERIORITY_OR_OTHER||Difference in response rate|-4.07|||||TWO_SIDED|95.0|-10.68|2.55||||||||2.55|-10.68|
71096984|NCT02187055|141702973|SUPERIORITY_OR_OTHER||Difference in response rate|-1.21|||||TWO_SIDED|95.0|-7.87|5.44||||||||5.44|-7.87|
71096985|NCT02187055|141702973|SUPERIORITY_OR_OTHER||Difference in response rate|2.86|||||TWO_SIDED|95.0|-3.72|9.43||||||||9.43|-3.72|
71096986|NCT02187055|141702974|SUPERIORITY_OR_OTHER||LS mean difference|-1.2|||||TWO_SIDED|95.0|-2.28|-0.11||||||||-0.11|-2.28|
71096987|NCT02187055|141702974|SUPERIORITY_OR_OTHER||LS mean difference|-1.1|||||TWO_SIDED|95.0|-2.16|0.01||||||||0.01|-2.16|
71096988|NCT02187055|141702974|SUPERIORITY_OR_OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.97|1.2||||||||1.20|-0.97|
71096989|NCT02187055|141702975|SUPERIORITY_OR_OTHER||LS mean difference|-0.4|||||TWO_SIDED|95.0|-1.74|0.85||||||||0.85|-1.74|
71096990|NCT02187055|141702975|SUPERIORITY_OR_OTHER||LS mean difference|0.8|||||TWO_SIDED|95.0|-0.48|2.11||||||||2.11|-0.48|
71096991|NCT02187055|141702975|SUPERIORITY_OR_OTHER||LS mean difference|1.3|||||TWO_SIDED|95.0|-0.04|2.56||||||||2.56|-0.04|
71096992|NCT02187055|141702976|SUPERIORITY_OR_OTHER||LS mean difference|-0.9|||||TWO_SIDED|95.0|-2.22|0.39||||||||0.39|-2.22|
71096993|NCT02187055|141702976|SUPERIORITY_OR_OTHER||LS mean difference|-0.9|||||TWO_SIDED|95.0|-2.19|0.42||||||||0.42|-2.19|
71096994|NCT02187055|141702976|SUPERIORITY_OR_OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-1.27|1.34||||||||1.34|-1.27|
71096995|NCT02187055|141702977|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|||||TWO_SIDED|95.0|-1.52|0.87||||||||0.87|-1.52|
71096996|NCT02187055|141702977|SUPERIORITY_OR_OTHER||LS mean difference|0.4|||||TWO_SIDED|95.0|-0.8|1.58||||||||1.58|-0.80|
71096997|NCT02187055|141702977|SUPERIORITY_OR_OTHER||LS mean difference|0.7|||||TWO_SIDED|95.0|-0.47|1.91||||||||1.91|-0.47|
71096998|NCT02187055|141702978|SUPERIORITY_OR_OTHER||LS mean difference|-2.0|||||TWO_SIDED|95.0|-3.25|-0.8||||||||-0.80|-3.25|
71096999|NCT02187055|141702978|SUPERIORITY_OR_OTHER||LS mean difference|-1.7|||||TWO_SIDED|95.0|-2.91|-0.47||||||||-0.47|-2.91|
71097000|NCT02187055|141702978|SUPERIORITY_OR_OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|-0.89|1.55||||||||1.55|-0.89|
71097001|NCT02187055|141702979|SUPERIORITY_OR_OTHER||LS mean difference|-1.2|||||TWO_SIDED|95.0|-2.27|-0.05||||||||-0.05|-2.27|
71097002|NCT02187055|141702979|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|||||TWO_SIDED|95.0|-1.4|0.82||||||||0.82|-1.40|
71097003|NCT02187055|141702979|SUPERIORITY_OR_OTHER||LS mean difference|0.9|||||TWO_SIDED|95.0|-0.25|1.98||||||||1.98|-0.25|
71097004|NCT02187055|141702980|SUPERIORITY_OR_OTHER||LS mean difference|-0.5|||||TWO_SIDED|95.0|-1.71|0.68||||||||0.68|-1.71|
71097005|NCT02187055|141702980|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-1.33|1.05||||||||1.05|-1.33|
71097006|NCT02187055|141702980|SUPERIORITY_OR_OTHER||LS mean difference|0.4|||||TWO_SIDED|95.0|-0.83|1.57||||||||1.57|-0.83|
71097007|NCT02187055|141702981|SUPERIORITY_OR_OTHER||LS mean difference|-0.9|||||TWO_SIDED|95.0|-2.2|0.45||||||||0.45|-2.20|
71097008|NCT02187055|141702981|SUPERIORITY_OR_OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-1.13|1.51||||||||1.51|-1.13|
71097009|NCT02187055|141702981|SUPERIORITY_OR_OTHER||LS mean difference|1.1|||||TWO_SIDED|95.0|-0.26|2.39||||||||2.39|-0.26|
71097010|NCT02187055|141702982|SUPERIORITY_OR_OTHER||LS mean difference|-1.1|||||TWO_SIDED|95.0|-2.54|0.39||||||||0.39|-2.54|
71097011|NCT02187055|141702982|SUPERIORITY_OR_OTHER||LS mean difference|0.7|||||TWO_SIDED|95.0|-0.76|2.16||||||||2.16|-0.76|
70981465|NCT01212445|141470756|SUPERIORITY_OR_OTHER||Treatment Success Rate|0.118||||0.7746|TWO_SIDED|95.0|0.044|0.239|||Fisher Exact|||The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).||0.239|0.044|0.7746
70981466|NCT01212445|141470756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.233|||||TWO_SIDED|95.0|0.628|7.94|||Regression, Logistic|||"Logistic regression analysis was performed with treatment success as the dichotomous dependent variable and dose (13.125g, 26.25g, or 39.375 g) as the independent variable. The main effects for the model were tested for significance at the 5% level.~The odds of response for the 26.25 g dose level versus the 13.125 g dose level were presented together with the associated 95% confidence intervals. There were no multiplicity adjustments."||7.940|0.628|
71097012|NCT02187055|141702982|SUPERIORITY_OR_OTHER||LS mean difference|1.8|||||TWO_SIDED|95.0|0.3|3.24||||||||3.24|0.30|
71097013|NCT02187055|141702983|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|||||TWO_SIDED|95.0|-1.55|1.08||||||||1.08|-1.55|
71097014|NCT02187055|141702983|SUPERIORITY_OR_OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|-1.01|1.62||||||||1.62|-1.01|
71097015|NCT02187055|141702983|SUPERIORITY_OR_OTHER||LS mean difference|0.5|||||TWO_SIDED|95.0|-0.78|1.86||||||||1.86|-0.78|
71097016|NCT02187055|141702984|SUPERIORITY_OR_OTHER||LS mean difference|-0.43|||||TWO_SIDED|95.0|-2.279|1.427||||||Work hours missed due to problems||1.427|-2.279|
71097017|NCT02187055|141702984|SUPERIORITY_OR_OTHER||LS mean difference|-0.87|||||TWO_SIDED|95.0|-2.783|1.044||||||Work hours missed due to problems||1.044|-2.783|
71097018|NCT02187055|141702984|SUPERIORITY_OR_OTHER||LS mean difference|-0.44|||||TWO_SIDED|95.0|-2.349|1.462||||||Work hours missed due to problems||1.462|-2.349|
71097019|NCT02187055|141702984|SUPERIORITY_OR_OTHER||LS mean difference|-0.29|||||TWO_SIDED|95.0|-2.928|2.346||||||Work hours missed other reason||2.346|-2.928|
71097020|NCT02187055|141702984|SUPERIORITY_OR_OTHER||LS mean difference|0.9|||||TWO_SIDED|95.0|-1.832|3.64||||||Work hours missed other reason||3.640|-1.832|
71097021|NCT02187055|141702984|SUPERIORITY_OR_OTHER||LS mean difference|1.2|||||TWO_SIDED|95.0|-1.52|3.911||||||Work hours missed other reason||3.911|-1.520|
71097022|NCT02187055|141702984|SUPERIORITY_OR_OTHER||LS mean difference|4.95|||||TWO_SIDED|95.0|0.52|9.37||||||Hours worked in past 7 days||9.370|0.520|
71097023|NCT02187055|141702984|SUPERIORITY_OR_OTHER||LS mean difference|2.85|||||TWO_SIDED|90.0|-1.736|7.43||||||Hours worked in past 7 days||7.430|-1.736|
71097024|NCT02187055|141702984|SUPERIORITY_OR_OTHER||LS mean difference|-2.1|||||TWO_SIDED|95.0|-6.65|2.454||||||Hours worked in past 7 days||2.454|-6.650|
71097025|NCT02187055|141702984|SUPERIORITY_OR_OTHER||LS mean difference|0.21|||||TWO_SIDED|95.0|-0.373|0.786||||||Problems affecting productivity||0.786|-0.373|
71097026|NCT02187055|141702984|SUPERIORITY_OR_OTHER||LS mean difference|0.01|||||TWO_SIDED|95.0|-0.578|0.607||||||Problems affecting productivity||0.607|-0.578|
71097027|NCT02187055|141702984|SUPERIORITY_OR_OTHER||LS mean difference|-0.19|||||TWO_SIDED|95.0|-0.784|0.4||||||Problems affecting productivity||0.400|-0.784|
71097028|NCT02187055|141702984|SUPERIORITY_OR_OTHER||LS mean difference|0.24|||||TWO_SIDED|95.0|-0.112|0.587||||||Problem affecting daily activities||0.587|-0.112|
71097029|NCT02187055|141702984|SUPERIORITY_OR_OTHER||LS mean difference|0.01|||||TWO_SIDED|95.0|-0.341|0.357||||||Problem affecting daily activities||0.357|-0.341|
71097030|NCT02187055|141702984|SUPERIORITY_OR_OTHER||LS mean difference|-0.23|||||TWO_SIDED|95.0|-0.582|0.122||||||Problem affecting daily activities||0.122|-0.582|
71097031|NCT02187055|141702984|SUPERIORITY_OR_OTHER||LS mean difference|-1.1|||||TWO_SIDED|95.0|-5.748|3.553||||||% work time missed due to health||3.553|-5.748|
71097032|NCT02187055|141702984|SUPERIORITY_OR_OTHER||LS mean difference|-2.64|||||TWO_SIDED|95.0|-7.339|2.067||||||% work time missed due to health||2.067|-7.339|
71097033|NCT02187055|141702984|SUPERIORITY_OR_OTHER||LS mean difference|-1.54|||||TWO_SIDED|95.0|-6.283|3.207||||||% work time missed due to health||3.207|-6.283|
71097034|NCT02187055|141702984|SUPERIORITY_OR_OTHER||LS mean difference|2.07|||||TWO_SIDED|95.0|-3.726|7.858||||||% impairment while working due to health||7.858|-3.726|
71097035|NCT02187055|141702984|SUPERIORITY_OR_OTHER||LS mean difference|0.15|||||TWO_SIDED|95.0|-5.777|6.068||||||% impairment while working due to health||6.068|-5.777|
71097036|NCT02187055|141702984|SUPERIORITY_OR_OTHER||LS mean difference|-1.92|||||TWO_SIDED|95.0|-7.839|3.998||||||% impairment while working due to health||3.998|-7.839|
71097037|NCT02187055|141702984|SUPERIORITY_OR_OTHER||LS mean difference|2.11|||||TWO_SIDED|95.0|-4.664|8.877||||||% overall work impairment due to health||8.877|-4.664|
71097038|NCT02187055|141702984|SUPERIORITY_OR_OTHER||LS mean difference|1.71|||||TWO_SIDED|95.0|-5.164|8.58||||||% overall work impairment due to health||8.580|-5.164|
71097039|NCT02187055|141702984|SUPERIORITY_OR_OTHER||LS mean difference|-0.4|||||TWO_SIDED|95.0|-7.307|6.51||||||% overall work impairment due to health||6.510|-7.307|
71097040|NCT02187055|141702984|SUPERIORITY_OR_OTHER||LS mean difference|2.38|||||TWO_SIDED|95.0|-1.118|5.873||||||% activity impairment due to health||5.873|-1.118|
71097041|NCT02187055|141702984|SUPERIORITY_OR_OTHER||LS mean difference|0.08|||||TWO_SIDED|95.0|-3.411|3.573||||||% activity impairment due to health||3.573|-3.411|
71097042|NCT02187055|141702984|SUPERIORITY_OR_OTHER||LS mean difference|-2.3|||||TWO_SIDED|95.0|-5.818|1.225||||||% activity impairment due to health||1.225|-5.818|
71097043|NCT02187055|141702985|SUPERIORITY_OR_OTHER||LS mean difference|-0.02|||||TWO_SIDED|95.0|-0.057|0.011||||||Utility score||0.011|-0.057|
71097044|NCT02187055|141702985|SUPERIORITY_OR_OTHER||LS mean difference|-0.02|||||TWO_SIDED|95.0|-0.054|0.013||||||Utility score||0.013|-0.054|
71035820|NCT03602339|141580488|NON_INFERIORITY|"The score to evaluate the non-inferiority is calculated for each subject as (combined unenhanced/gadobutrol-enhanced - unenhanced) - 0.8\*(combined unenhanced/gadoterate-enhanced - unenhanced). The 95% CI is based on a t-distribution. The non-inferiority for gadobutrol is achieved if the one-sided p-value for H0: (gadobutrol minus unenhanced) - 0.8\*(gadoterate minus unenhanced) ≤ 0 is lower than 0.025."|Mean Difference (Final Values)|0.455|||<|0.0001|TWO_SIDED|95.0|0.347|0.562||No type I error adjustment for multiple comparisons is needed because tests on all 3 primary efficacy variables must be significant to demonstrate primary efficacy.|Paired t-test|||Difference (gadobutrol minus unenhanced) - (gadoterate minus unenhanced)||0.562|0.347|< 0.0001
71035821|NCT03602339|141580489|NON_INFERIORITY|"The score to evaluate the non-inferiority is calculated for each subject as (combined unenhanced/gadobutrol-enhanced - unenhanced) - 0.8\*(combined unenhanced/gadoterate-enhanced - unenhanced). The 95% CI is based on a t-distribution. The non-inferiority for gadobutrol is achieved if the one-sided p-value for H0: (gadobutrol minus unenhanced) - 0.8\*(gadoterate minus unenhanced) ≤ 0 is lower than 0.025."|Mean Difference (Final Values)|0.18|||=|0.0151|TWO_SIDED|95.0|0.017|0.342||No type I error adjustment for multiple comparisons is needed because tests on all 3 primary efficacy variables must be significant to demonstrate primary efficacy.|Paired t-test|||Difference (gadobutrol minus unenhanced) - (gadoterate minus unenhanced)||0.342|0.017|= 0.0151
71035822|NCT03602339|141580490|NON_INFERIORITY|"The score to evaluate the non-inferiority is calculated for each subject as (combined unenhanced/gadobutrol-enhanced - unenhanced) - 0.8\*(combined unenhanced/gadoterate-enhanced - unenhanced). The 95% CI is based on a t-distribution. The non-inferiority for gadobutrol is achieved if the one-sided p-value for H0: (gadobutrol minus unenhanced) - 0.8\*(gadoterate minus unenhanced) ≤ 0 is lower than 0.025."|Mean Difference (Final Values)|0.15|||=|0.01|TWO_SIDED|95.0|0.024|0.275||No type I error adjustment for multiple comparisons is needed because tests on all 3 primary efficacy variables must be significant to demonstrate primary efficacy.|Paired t-test|||Difference (gadobutrol minus unenhanced) - (gadoterate minus unenhanced)||0.275|0.024|= 0.0100
71035823|NCT03602339|141580491|NON_INFERIORITY|Non-inferiority margin is 0.35. If the lower limit of the 95% CI is \> -0.35, then non-inferiority is achieved.|Mean Difference (Final Values)|0.073|||||TWO_SIDED|95.0|-0.03|0.176||||||Difference (Gadobutrol - Gadoterate)||0.176|-0.030|
71035824|NCT03602339|141580492|NON_INFERIORITY|Non-inferiority margin = 10%, if the lower limit of the confidence interval \> -10%, then non-inferiority is achieved.|Difference (Gadobutrol - Gadoterate)|0.0|||||TWO_SIDED|95.0|-3.4|3.4|||||The 95% confidence intervals are based on McNemar's test.|Accuracy Difference (Gadobutrol - Gadoterate)||3.40|-3.40|
71097045|NCT02187055|141702985|SUPERIORITY_OR_OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.031|0.036||||||Utility score||0.036|-0.031|
71097046|NCT02187055|141702985|SUPERIORITY_OR_OTHER||LS mean difference|-0.03|||||TWO_SIDED|95.0|-0.098|0.042||||||Mobility score||0.042|-0.098|
71097047|NCT02187055|141702985|SUPERIORITY_OR_OTHER||LS mean difference|-0.01|||||TWO_SIDED|95.0|-0.079|0.06||||||Mobility score||0.060|-0.079|
71097048|NCT02187055|141702985|SUPERIORITY_OR_OTHER||LS mean difference|0.02|||||TWO_SIDED|95.0|-0.051|0.089||||||Mobility score||0.089|-0.051|
71097049|NCT02187055|141702985|SUPERIORITY_OR_OTHER||LS mean difference|0.06|||||TWO_SIDED|95.0|-0.014|0.127||||||Self-care score||0.127|-0.014|
71097050|NCT02187055|141702985|SUPERIORITY_OR_OTHER||LS mean difference|0.04|||||TWO_SIDED|95.0|-0.027|0.114||||||Self-care score||0.114|-0.027|
71035825|NCT03602339|141580492|NON_INFERIORITY|Non-inferiority margin = 10%, if the lower limit of the confidence interval \> -10%, then non-inferiority is achieved.|Difference (Gadobutrol - Gadoterate)|0.0|||||TWO_SIDED|95.0|-5.22|5.22|||||The 95% confidence intervals are based on McNemar's test.|Sensitivity Difference (Gadobutrol - Gadoterate)||5.22|-5.22|
71035826|NCT03602339|141580492|NON_INFERIORITY|Non-inferiority margin = 10%, if the lower limit of the confidence interval \> -10%, then non-inferiority is achieved.|Difference (Gadobutrol - Gadoterate)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The 95% confidence intervals are based on McNemar's test. No continuity correction for calculation of the confidence interval was included. Zero cells lead to degenerated confidence interval.|Specificity Difference (Gadobutrol - Gadoterate)||0.00|0.00|
71035827|NCT03602339|141580493|OTHER||Mean Difference (Final Values)|0.076|||||TWO_SIDED|95.0|0.011|0.14||||||Difference (Gadobutrol - Gadoterate)||0.140|0.011|
71035828|NCT03602339|141580494|OTHER||Mean Difference (Final Values)|0.0||||0.9149|TWO_SIDED|95.0|-0.1|0.11|||Wilcoxon signed-rank test|||Comparison of image quality between gadobutrol and gadoterate||0.11|-0.10|0.9149
71035829|NCT03602339|141580495|OTHER||Mean Difference (Final Values)|-0.01968|||||TWO_SIDED|95.0|-0.03491|-0.00445||||||Difference (Gadobutrol-Gadoterate) for Relative score||-0.00445|-0.03491|
71035830|NCT03602339|141580495|OTHER||Mean Difference (Final Values)|0.00586|||||TWO_SIDED|95.0|-0.00589|0.01762||||||Difference (Gadobutrol-Gadoterate) for Full image score||0.01762|-0.00589|
71035831|NCT03602339|141580495|OTHER||Mean Difference (Final Values)|0.00139|||||TWO_SIDED|95.0|-0.00471|0.00749||||||Difference (Gadobutrol-Gadoterate) for Dice score||0.00749|-0.00471|
71035832|NCT03602339|141580497|EQUIVALENCE|An equivalence test was calculated using the two one-sided t-tests (TOST) procedure with null hypotheses H01: (gadobutrol - gadoterate) ≤ -0.05 \* (gadoterate), and H02: (gadobutrol - gadoterate) ≥ +0.05 \* (gadoterate).||||||0.0049||||||The overall p-value was calculated as max(p1, p2) where p1 and p2 are the results of null hypotheses H01 and H02 respectively.|Two one-sided t-tests (TOST)|||||||0.0049
71097051|NCT02187055|141702985|SUPERIORITY_OR_OTHER||LS mean difference|-0.01|||||TWO_SIDED|95.0|-0.083|0.058||||||Self-care score||0.058|-0.083|
71097052|NCT02187055|141702985|SUPERIORITY_OR_OTHER||LS mean difference|0.01|||||TWO_SIDED|95.0|-0.062|0.084||||||Usual activities score||0.084|-0.062|
71097053|NCT02187055|141702985|SUPERIORITY_OR_OTHER||LS mean difference|0.06|||||TWO_SIDED|95.0|-0.018|0.129||||||Usual activities score||0.129|-0.018|
71097054|NCT02187055|141702985|SUPERIORITY_OR_OTHER||LS mean difference|0.04|||||TWO_SIDED|95.0|-0.029|0.118||||||Usual activities score||0.118|-0.029|
71097055|NCT02187055|141702985|SUPERIORITY_OR_OTHER||LS mean difference|0.03|||||TWO_SIDED|95.0|-0.041|0.091||||||Pain/discomfort score||0.091|-0.041|
71097056|NCT02187055|141702985|SUPERIORITY_OR_OTHER||LS mean difference|0.05|||||TWO_SIDED|95.0|-0.015|0.116||||||Pain/discomfort score||0.116|-0.015|
71097057|NCT02187055|141702985|SUPERIORITY_OR_OTHER||LS mean difference|0.03|||||TWO_SIDED|95.0|-0.041|0.091||||||Pain/discomfort score||0.091|-0.041|
71035833|NCT03602339|141580498|EQUIVALENCE|An equivalence test was calculated using the two one-sided t-tests (TOST) procedure with null hypotheses H01: (gadobutrol - gadoterate) ≤ -0.05 \* (gadoterate) and H02: (gadobutrol - gadoterate) ≥ +0.05 \* (gadoterate).||||||0.0013||||||The overall p-value was calculated as max(p1, p2) where p1 and p2 are the results of null hypotheses H01 and H02 respectively.|Two one-sided t-tests (TOST)|||||||0.0013
71035834|NCT03602339|141580499|EQUIVALENCE|An equivalence test was calculated using the two one-sided t-tests (TOST) procedure with null hypotheses H01: (gadobutrol - gadoterate) ≤ -0.05 \* (gadoterate) and H02: (gadobutrol - gadoterate) ≥ +0.05 \* (gadoterate).||||||0.0065||||||The overall p-value was calculated as max(p1, p2) where p1 and p2 are the results of null hypotheses H01 and H02 respectively.|Two one-sided t-tests (TOST)|||||||0.0065
71035835|NCT03503318|141580536|OTHER||Hazard Ratio (HR)|0.2|||<|0.0001|TWO_SIDED|95.0|0.109|0.367||Threshold for significance at 0.05 level.|Log Rank|||Analysis was performed using the stratified Cox proportional hazard model, with treatment (placebo, TV-46000 q1m and TV-46000 q2m or placebo and TV-46000 overall \[including q1m and q2m\]) as explanatory variable and sex-dose as a stratification factor, and the stratified log rank test p-value (sex-dose as a stratification factor) referred to (TV-46000/placebo) comparison.||0.367|0.109|<0.0001
71035836|NCT03503318|141580536|OTHER||Hazard Ratio (HR)|0.375|||<|0.0001|TWO_SIDED|95.0|0.227|0.618||Threshold for significance at 0.05 level.|Log Rank|||Analysis was performed using the stratified Cox proportional hazard model, with treatment (placebo, TV-46000 q1m and TV-46000 q2m or placebo and TV-46000 overall \[including q1m and q2m\]) as explanatory variable and sex-dose as a stratification factor, and the stratified log rank test p-value (sex-dose as a stratification factor) referred to (TV-46000/placebo) comparison.||0.618|0.227|<0.0001
71035837|NCT00834873|141580566|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|94.77||||||90.0|85.04|105.61|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.61|85.04|
71097058|NCT02187055|141702985|SUPERIORITY_OR_OTHER||LS mean difference|0.03|||||TWO_SIDED|95.0|-0.046|0.103||||||Anxiety/depression score||0.103|-0.046|
71097059|NCT02187055|141702985|SUPERIORITY_OR_OTHER||LS mean difference|0.01|||||TWO_SIDED|95.0|-0.066|0.083||||||Anxiety/depression score||0.083|-0.066|
71097060|NCT02187055|141702985|SUPERIORITY_OR_OTHER||LS mean difference|-0.02|||||TWO_SIDED|95.0|-0.094|0.055||||||Anxiety/depression score||0.055|-0.094|
71097061|NCT02187055|141702985|SUPERIORITY_OR_OTHER||LS mean difference|-0.14|||||TWO_SIDED|95.0|-2.934|2.648||||||VAS score||2.648|-2.934|
71035838|NCT00834873|141580567|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.23||||||90.0|90.59|102.23|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||102.23|90.59|
71035839|NCT00834873|141580568|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.11||||||90.0|90.45|102.12|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||102.12|90.45|
71035840|NCT02635750|141580643|OTHER||Adjusted gMean ratio(%)|99.95|||||TWO_SIDED|90.0|89.502|111.62|||||"Ratio of BI 409306 25mg with donepezil 10mg and BI 409306 25mg alone (BI 409306+ don / BI 409306).~Intra-individual coefficient of variation (gCV (%)) = 18.6."|"The statistical model used for the analysis of those endpoints was an analysis of variance (ANOVA) model on the logarithmic scale (natural logarithm). This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas the other effect was considered as fixed.~Abbreviations used: geometric mean (gMean), donepezil (don)"||111.62|89.502|
71035841|NCT02635750|141580644|OTHER||Adjusted gMean ratio(%)|100.82|||||TWO_SIDED|90.0|81.861|124.17|||||Ratio of BI 409306 25mg with donepezil 10mg and BI 409306 25mg alone (BI 409306+don / BI 409306). Intra-individual coefficient of variation (gCV (%)) = 35.8.|"The statistical model used for the analysis of those endpoints was an analysis of variance (ANOVA) model on the logarithmic scale (natural logarithm). This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas the other effect was considered as fixed.~Abbreviations used: geometric mean (gMean), donepezil (don)"||124.17|81.861|
71035842|NCT02635750|141580645|OTHER||Adjusted gMean ratio (%)|100.84|||||TWO_SIDED|90.0|97.584|104.19|||||Ratio of donepezil 5mg with BI 409306 100mg and donepezil 5mg alone (BI 409306+don / don). Intra-individual coefficient of variation (gCV (%)) = 4.9.|The PK endpoints were log transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'periods' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. Abbreviations used: geometric mean (gMean), donepezil (don)||104.19|97.584|
71097062|NCT02187055|141702985|SUPERIORITY_OR_OTHER||LS mean difference|1.23|||||TWO_SIDED|95.0|-1.556|4.016||||||VAS score||4.016|-1.556|
71097063|NCT02187055|141702985|SUPERIORITY_OR_OTHER||LS mean difference|1.37|||||TWO_SIDED|95.0|-1.425|4.171||||||VAS score||4.171|-1.425|
71097064|NCT02187055|141702986|SUPERIORITY_OR_OTHER||LS mean difference|-0.45|||||TWO_SIDED|95.0|-1.706|0.808||||||||0.808|-1.706|
71097065|NCT02187055|141702986|SUPERIORITY_OR_OTHER||LS mean difference|1.07|||||TWO_SIDED|95.0|-0.178|2.325||||||||2.325|-0.178|
71097066|NCT02187055|141702986|SUPERIORITY_OR_OTHER||LS mean difference|1.52|||||TWO_SIDED|95.0|0.266|2.779||||||||2.779|0.266|
71097067|NCT03520387|141702988|SUPERIORITY||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-10.2|3.7|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Negative scores indicate benefit with LRFA over simulated LRFA.|||3.7|-10.2|
71097068|NCT03520387|141702988|SUPERIORITY||Mean Difference (Final Values)|-6.3|STANDARD_ERROR_OF_MEAN|2.1|||TWO_SIDED|95.0|-11.0|-1.6|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Negative scores indicate benefit with AcTIVE-CBT over TBSCE.|||-1.6|-11.0|
71097069|NCT03520387|141702989|SUPERIORITY||Mean Difference (Final Values)|-6059.0|STANDARD_ERROR_OF_MEAN|2832.7|||TWO_SIDED|95.0|-12467.0|349.1|||||This is an analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on CHANGE in step counts, after adjustment for age and baseline step counts. Positive values show increased steps with LRFA over simulated LRFA.|||349.1|-12467.0|
71097070|NCT03520387|141702989|SUPERIORITY||Mean Difference (Final Values)|2081.9|STANDARD_ERROR_OF_MEAN|2983.2|||TWO_SIDED|95.0|-4666.6|8830.4|||||This is an analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on CHANGE in step counts, after adjustment for age and baseline step counts.Positive values show increased steps with AcTIVE-CBT over TBSCE.|||8830.4|-4666.6|
71097071|NCT03520387|141702990|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|1.8|||TWO_SIDED|95.0|-5.2|3.1|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Negative scores indicate benefit with LRFA over simulated LRFA.|||3.1|-5.2|
71097072|NCT03520387|141702990|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|1.7|||TWO_SIDED|95.0|-4.2|3.6|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Negative scores indicate benefit with AcTIVE-CBT over TBSCE.|||3.6|-4.2|
71097073|NCT03520387|141702991|SUPERIORITY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-8.1|10.1|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months after adjustment for age and baseline value of the outcome. Positive scores indicate better health with LRFA vs. simulated LRFA.|PROMIS physical health scores||10.1|-8.1|
71097074|NCT03520387|141702991|SUPERIORITY||Mean Difference (Final Values)|6.2|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-0.4|12.9|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months after adjustment for age and baseline value of the outcome. Positive scores indicate better health with AcTIVE-CBT vs. TBSCE|PROMIS physical health scores||12.9|-0.4|
71097075|NCT03520387|141702991|SUPERIORITY||Mean Difference (Final Values)|3.7|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-5.4|12.7|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months after adjustment for age and baseline value of the outcome. Positive scores indicate better health with LRFA vs. simulated LRFA.|PROMIS mental health scores||12.7|-5.4|
71097076|NCT03520387|141702991|SUPERIORITY||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|3.9|||TWO_SIDED|95.0|-7.0|10.6|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months after adjustment for age and baseline value of the outcome. Positive scores indicate better health with AcTIVE-CBT vs. TBSCE|PROMIS mental health scores||10.6|-7.0|
71097077|NCT03520387|141702992|SUPERIORITY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|2.1|||TWO_SIDED|95.0|-7.7|1.9|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Negative scores indicate lower doses with LRFA over simulated LRFA.|||1.9|-7.7|
71097078|NCT03520387|141702992|SUPERIORITY||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|95.0|-7.5|1.0|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Negative scores indicate lower doses with AcTIVE-CBT over TBSCE.|||1.0|-7.5|
71097079|NCT03520387|141702993|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-1.4|1.7|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months, after adjustment for age. Positive scores indicate perceived benefit with LRFA over simulated LRFA.|||1.7|-1.4|
71097080|NCT03520387|141702993|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-1.3|1.5|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Positive scores indicate perceived benefit with AcTIVE-CBT over TBSCE.|||1.5|-1.3|
71097081|NCT03520387|141702994|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|-5.5|3.7|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months after adjustment for age and baseline value of the outcome. Negative scores indicate less pain with LRFA over simulated LRFA.|||3.7|-5.5|
71097082|NCT03520387|141702994|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.8|||TWO_SIDED|95.0|-5.4|2.6|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months after adjustment for age and baseline value of the outcome. Negative scores indicate less pain with AcTIVE-CBT vs. TBSCE|||2.6|-5.4|
71097083|NCT03520387|141702995|SUPERIORITY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|95.0|-0.5|3.0|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months, after adjustment for age. Positive scores indicate more satisfaction with LRFA over simulated LRFA.|||3.0|-0.5|
71097084|NCT03520387|141702995|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-0.4|2.8|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months, after adjustment for age. Positive scores indicate more satisfaction with AcTIVE-CBT over TBSCE.|||2.8|-0.4|
71097085|NCT03520387|141702996|SUPERIORITY||Mean Difference (Final Values)|-637.0|STANDARD_ERROR_OF_MEAN|433.3|||TWO_SIDED|95.0|-1636.2|362.1|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months adjusting for age and baseline value of the outcome. Positive scores indicate greater activity with LRFA over simulated LRFA.|||362.1|-1636.2|
71097086|NCT03520387|141702996|SUPERIORITY||Mean Difference (Final Values)|572.2|STANDARD_ERROR_OF_MEAN|334.5|||TWO_SIDED|95.0|-199.3|1343.6|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months adjusting for age and baseline value of the outcome. Positive scores indicate more satisfaction with AcTIVE-CBT over TBSCE.|||1343.6|-199.3|
71097087|NCT03336866|141702997|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 5 (primary). Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
71097088|NCT03336866|141702997|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 12. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
71097089|NCT03336866|141702997|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 19 (primary). Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
71097090|NCT03336866|141702997|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 26. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
71097091|NCT03336866|141702997|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 5 (primary). Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
70981467|NCT01212445|141470756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||||TWO_SIDED|95.0|0.424|6.043|||Regression, Logistic|||"Logistic regression analysis was performed with treatment success as the dichotomous dependent variable and dose (13.125g, 26.25g, or 39.375 g) as the independent variable. The main effects for the model were tested for significance at the 5% level.~The odds of response for the 39.375 g dose level versus the 13.125 g dose level were presented together with the associated 95% confidence intervals. There were no multiplicity adjustments."||6.043|0.424|
70981468|NCT01212445|141470757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.752||||0.1876|TWO_SIDED|95.0|-3.834|19.338|||ANCOVA|||||19.338|-3.834|0.1876
70981469|NCT01212445|141470757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.706||||0.768|TWO_SIDED|95.0|-9.729|13.141|||ANCOVA|||||13.141|-9.729|0.7680
70981470|NCT01212445|141470757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.046||||0.2941|TWO_SIDED|95.0|-17.412|5.32|||ANCOVA|||||5.320|-17.412|0.2941
70981471|NCT01212445|141470758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.302||||0.8109|TWO_SIDED|95.0|-12.059|9.454|||ANCOVA|||||9.454|-12.059|0.8109
70981472|NCT01212445|141470758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.075||||0.6995|TWO_SIDED|95.0|-12.693|8.544|||ANCOVA|||||8.544|-12.693|0.6995
70981473|NCT01212445|141470758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.772||||0.885|TWO_SIDED|95.0|-11.329|9.784|||ANCOVA|||||9.784|-11.329|0.8850
70981474|NCT01212445|141470759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.886||||0.0486|TWO_SIDED|95.0|0.078|25.695|||ANCOVA|||||25.695|0.078|0.0486
70981475|NCT01212445|141470759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.245||||0.8465|TWO_SIDED|95.0|-11.471|13.962|||ANCOVA|||||13.962|-11.471|0.8465
70981476|NCT01212445|141470759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.641||||0.0744|TWO_SIDED|95.0|-24.449|1.167|||ANCOVA|||||1.167|-24.449|0.0744
70981477|NCT01212445|141470760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.69||||0.4591|TWO_SIDED|95.0|-6.153|13.534|||ANCOVA|||||13.534|-6.153|0.4591
71097092|NCT03336866|141702997|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 12. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
70981478|NCT01212445|141470760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.887||||0.5546|TWO_SIDED|95.0|-6.765|12.539|||ANCOVA|||||12.539|-6.765|0.5546
70981479|NCT01212445|141470760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.803||||0.8685|TWO_SIDED|95.0|-10.397|8.79|||ANCOVA|||||8.790|-10.397|0.8685
70981480|NCT01212445|141470761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.311||||0.1865|TWO_SIDED|95.0|-0.774|0.152|||ANCOVA|||||0.152|-0.774|0.1865
70981481|NCT01212445|141470761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.139||||0.553|TWO_SIDED|95.0|-0.602|0.323|||ANCOVA|||||0.323|-0.602|0.5530
70981482|NCT01212445|141470761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172||||0.467|TWO_SIDED|95.0|-0.293|0.637|||ANCOVA|||||0.637|-0.293|0.4670
70981483|NCT01056107|141470788|SUPERIORITY_OR_OTHER|||||||0.0075||95.0|||||Dunnett's test|||||||0.0075
70981484|NCT01056107|141470788|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Dunnett's test|||||||<0.001
70981485|NCT01614457|141470796|SUPERIORITY_OR_OTHER||Least squares (LS) Mean Difference|2.1114||||0.1979|TWO_SIDED|95.0|-1.1305|5.3532|||Mixed Model Repeated Measures|||Analysis was based on mixed effects model for repeated measures (MMRM) with dependent variable absolute change from baseline, with treatment group, visit and treatment by visit interaction as fixed effects, subject as random effect, and with adjustment for the continuous baseline value of age and percent predicted FEV1, using compound symmetry covariance matrix.||5.3532|-1.1305|0.1979
70981486|NCT01614457|141470797|SUPERIORITY_OR_OTHER||LS Mean difference|0.2626||||0.778|TWO_SIDED|95.0|-1.5698|2.095||p-value for the treatment effect is from the slope of BMI (kg/m2) versus time (days).|Linear Mixed model|||Analysis was based on linear mixed model with dependent variable BMI and treatment as a fixed effect, adjustment for baseline percent predicted FEV1, age and visit by treatment interaction was included as covariates and intercept, visit were included as random effects.||2.0950|-1.5698|0.7780
70981487|NCT01614457|141470798|SUPERIORITY_OR_OTHER||LS Mean difference|-23.9693|||<|0.0001|TWO_SIDED|95.0|-28.0094|-19.9293|||Mixed Model Repeated Measures|||Analysis was based on MMRM with dependent variable absolute change from baseline, with treatment group, visit and treatment by visit interaction as fixed effects, subject as random effect, and with adjustment for the continuous baseline value of age and percent predicted FEV1, and sweat chloride, using a compound symmetry covariance matrix.||-19.9293|-28.0094|<0.0001
70981488|NCT01614457|141470799|SUPERIORITY_OR_OTHER||LS Mean difference|8.3874||||0.0091|TWO_SIDED|95.0|2.1658|14.609|||Mixed Model Repeated Measures|||Analysis was based on MMRM with dependent variable absolute change from baseline, with treatment group, visit and treatment by visit interaction as fixed effects, subject as random effect, and with adjustment for the continuous baseline value of age and percent predicted FEV1, and CFQ-R respiratory domain score, using compound symmetry covariance matrix.||14.6090|2.1658|0.0091
70981489|NCT01614457|141470800|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.928||||0.8556|TWO_SIDED||||||Cox Proportional Hazard Regression|||||||0.8556
70981490|NCT00914628|141470826|SUPERIORITY|||||||0.8974|||||||Log Rank|||||||0.8974
70981491|NCT00914628|141470826|SUPERIORITY|||||||0.7612|||||||Wilcoxon (Mann-Whitney)|||DFS- Intention-To-Treat population- from baseline to day 21||||0.7612
70981492|NCT00914628|141470826|SUPERIORITY|||||||0.5995|||||||Log Rank|||||||0.5995
70981493|NCT00914628|141470826|SUPERIORITY|||||||0.4078|||||||Wilcoxon (Mann-Whitney)|||DFS- Intention-To-Treat population - day 21 after transplant||||0.4078
70981494|NCT00914628|141470826|SUPERIORITY|||||||0.3351|||||||Log Rank|||DFS- Per-Protocol Set||||0.3351
70981495|NCT00914628|141470826|SUPERIORITY|||||||0.1233|||||||Wilcoxon (Mann-Whitney)|||DFS- Per-Protocol Set||||0.1233
70981496|NCT00914628|141470826|EQUIVALENCE|||||||0.5995|||||||Log Rank|||DFS- Per-Protocol Set DFS-day 21 after transplant||||0.5995
70981497|NCT00914628|141470826|SUPERIORITY|||||||0.4078|||||||Wilcoxon (Mann-Whitney)|||DFS- Per-Protocol Set DFS-day 21 after transplant||||0.4078
70981498|NCT00914628|141470827|SUPERIORITY|||||||0.766|||||||Log Rank|Statistical analysis was performed on Intention-To-Treat population.||||||0.7660
70981499|NCT00914628|141470827|SUPERIORITY|||||||0.6706|||||||Wilcoxon (Mann-Whitney)|||Statistical analysis has been performed for Intention-To-Treat population.||||0.6706
70981500|NCT00914628|141470827|SUPERIORITY|||||||0.7332|||||||Log Rank|||Statistical analysis has been performed for Per-Protocol Set)||||0.7332
70981501|NCT00914628|141470827|SUPERIORITY|||||||0.6439|||||||Wilcoxon (Mann-Whitney)|||Statistical analysis has been performed for Per-Protocol Set)||||0.6439
70981502|NCT00914628|141470828|SUPERIORITY|||||||0.1735|||||||Chi-squared|||This Statistical analysis refers to Immune reconstitution and was performed by Gray's Test for Equality of Cumulative Incidence Functions for intention-To-Treat population||||0.1735
70981503|NCT00914628|141470828|SUPERIORITY|||||||0.5958|||||||Chi-squared|||This Statistical analysis refers to deaths without previous immune reconstitution, relapse or progression and was performed by Gray's Test for Equality of Cumulative Incidence Functions for intention-To-Treat population||||0.5958
70981504|NCT00914628|141470828|SUPERIORITY|||||||0.2889|||||||Chi-squared|||This Statistical Analysis refers to patients with relapse or progression without previous immune reconstitution and was performed Gray's Test for Equality of Cumulative Incidence Functions||||0.2889
70981505|NCT00914628|141470828|SUPERIORITY|||||||0.1642|||||||Chi-squared|||This Statistical analysis refers to Immune reconstitution and was performed by Gray's Test for Equality of Cumulative Incidence Functions for Per-Protocol Set.||||0.1642
70981506|NCT00914628|141470828|SUPERIORITY|||||||0.8739|||||||Log Rank|||This Statistical analysis refers to deaths without previous immune reconstitution, relapse or progression and was performed by Gray's Test for Equality of Cumulative Incidence Functions for intention-To-Treat population||||0.8739
70981507|NCT00914628|141470828|SUPERIORITY|||||||0.2304|||||||Chi-squared|||This Statistical Analysis refers to patients with relapse or progression without previous immune reconstitution and was performed Gray's Test for Equality of Cumulative Incidence Functions||||0.2304
70981508|NCT00914628|141470833|SUPERIORITY|||||||0.3526|||||||Chi-squared|||This Statistical Analysis refers to ITT Patients with relapse or progression and was performed with Gray's Test for Equality of Cumulative Incidence Functions||||0.3526
70981509|NCT00914628|141470833|SUPERIORITY|||||||0.4035|||||||Chi-squared|||this Gray's Statistical Analysis refers to ITT Deaths patients without previous relapse or progression and was performed with Test for Equality of Cumulative Incidence Functions||||0.4035
70981510|NCT00914628|141470833|SUPERIORITY|||||||0.2607|||||||Chi-squared|||this Gray's Statistical Analysis refers to PPS patients with relapse or progression and was performed with Test for Equality of Cumulative Incidence Functions||||0.2607
70981511|NCT00914628|141470833|SUPERIORITY|||||||0.5929|||||||Chi-squared|||this Gray's Statistical Analysis refers to PPS Deaths patients without previous relapse or progression and was performed with Test for Equality of Cumulative Incidence Function||||0.5929
70981512|NCT00914628|141470837|SUPERIORITY|||||||0.4035|||||||Chi-squared|||This Statistical Analysis refers to ITT Deaths without previous relapse or progression and was performed with Gray's Test for Equality of Cumulative Incidence Functions||||0.4035
70981513|NCT00914628|141470837|SUPERIORITY|||||||0.3526|||||||Chi-squared|||This statistical test refers to Patients with relapse or progression and was performed to Gray's Test for Equality of Cumulative Incidence Functions.||||0.3526
70981514|NCT00914628|141470837|SUPERIORITY|||||||0.5929|||||||Chi-squared|||This Statistical Analysis refers to PPS Deaths without previous relapse or progression and was performed with Gray's Test for Equality of Cumulative Incidence Functions||||0.5929
70981515|NCT00914628|141470837|SUPERIORITY|||||||0.2607|||||||Chi-squared|||This statistical test refers to Patients with relapse or progression and was performed to Gray's Test for Equality of Cumulative Incidence Functions.||||0.2607
70981516|NCT00473694|141470871|SUPERIORITY||Estimated Treatment Effect|17.29|||<|0.0001|TWO_SIDED|95.0|13.95|21.42||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.9 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.|||21.42|13.95|<0.0001
70981517|NCT00473694|141470872|SUPERIORITY||Estimated Treatment Effect|14.86|||<|0.0001|TWO_SIDED|95.0|10.18|21.67||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.9 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.|||21.67|10.18|<0.0001
70981518|NCT00473694|141470873|SUPERIORITY||Estimated Treatment Effect|15.84|||<|0.0001|TWO_SIDED|95.0|12.58|19.95||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.7 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.|||19.95|12.58|<0.0001
70981519|NCT00473694|141470874|SUPERIORITY||Estimated Treatment Effect|18.45|||<|0.0001|TWO_SIDED|95.0|13.98|24.35||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.7 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.|||24.35|13.98|<0.0001
71102638|NCT01979185|141713915|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% CI of the geometric mean ratios fell within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|0.632|||||TWO_SIDED|90.0|0.538|0.744|||Mixed-effects Model|||The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects, and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in pharmacokinetic parameters, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.||0.744|0.538|
70981520|NCT00473694|141470875|SUPERIORITY||Estimated Treatment Effect|17.04|||<|0.0001|TWO_SIDED|95.0|13.62|21.31||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.8 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.|||21.31|13.62|<0.0001
70981521|NCT00473694|141470876|SUPERIORITY||Estimated Treatment Effect|17.7|||<|0.0001|TWO_SIDED|95.0|12.85|24.38||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.8 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.|||24.38|12.85|<0.0001
70981522|NCT00469079|141470889|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.002
70981523|NCT00469079|141470890|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Mixed Models Analysis|||Product use is by self-report and daily diaries.||||0.05
70981524|NCT00469079|141470891|SUPERIORITY_OR_OTHER_LEGACY||Other|0.0|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|A generalized linear mixed model was used for outcomes that had been repeatedly measured from baseline through the end of the treatment period.||This study was not powered to detect differences in smoking cessation rates between groups; however, smoking status was collected to obtain preliminary data. Point prevalence (no smoking during the previous 7 days) cigarette abstinence rates were calculated at the week-4 visit and at each of the 2 follow-up visits. Continuous abstinence rates were calculated for the 4 week period between the week 1 and week 4 visits. Abstinence at all visits was assessed by self-report and confirmed by CO.||||<0.05
70981525|NCT00469079|141470892|SUPERIORITY_OR_OTHER_LEGACY||Mean difference between 3 groups|0.0|||>|0.1|TWO_SIDED|95.0|||||Mixed Models Analysis|||A generalized linear mixed model was used for outcomes that had been repeatedly measured from baseline through the end of the treatment period. Each repeated-measures model included the treatment effect, a visit effect, the interaction between treatment and visit, the interaction between subject error and within-subject error terms.||||> 0.10
70981526|NCT02698410|141470939|OTHER|||||||0.2968||||||One-sided p-value estimated using an exact binomial proportion test for one-way tables comparing DCR to 30%.|Binomial proportion test|||Comparison of DCR to 30% clinically relevant threshold.||||0.2968
70981527|NCT02698410|141470939|OTHER||||||<|0.0001||||||One-sided p-value estimated using an exact binomial proportion test for one-way tables comparing DCR to 10%.|Binomial proportion test|||Comparison of DCR to 10% clinically relevant threshold.||||<0.0001
70981528|NCT02698410|141470939|OTHER|||||||0.0534||||||One-sided p-value estimated using an exact binomial proportion test for one-way tables comparing DCR to 30%.|Binomial proportion test|||Sensitivity Analyisis-1: Comparison of DCR to 30% clinically relevant threshold.||||0.0534
70981529|NCT02698410|141470939|OTHER||||||<|0.0001||||||One-sided p-value estimated using an exact binomial proportion test for one-way tables comparing DCR to 10%.|Binomial proportion test|||Sensitivity Analyisis-1: Comparison of DCR to 10% clinically relevant threshold.||||<0.0001
70981530|NCT02698410|141470939|OTHER|||||||0.032||||||One-sided p-value estimated using an exact binomial proportion test for one-way tables comparing DCR to 30%.|Binomial proportion test|||Sensitivity Analyisis-2: Comparison of DCR to 30% clinically relevant threshold.||||0.032
71035843|NCT02635750|141580646|OTHER||Adjusted gMean ratio(%)|113.08|||||TWO_SIDED|90.0|106.41|120.15|||||Ratio of donepezil 5mg with BI 409306 100mg and donepezil 5mg alone. (BI 409306+don / don) Intra-individual coefficient of variation (gCV (%)) = 9.0.|"The PK endpoints were log transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'periods' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.~Abbreviations used: geometric mean (gMean), donepezil (don)"||120.15|106.41|
71035844|NCT02635750|141580647|OTHER||Adjusted gMean ratio(%)|100.01|||||TWO_SIDED|90.0|89.549|111.68|||||Ratio of BI 409306 25mg with donepezil 10mg and BI 409306 25mg alone (BI 409306+don/ BI 409306). Intra-individual coefficient of variation (gCV(%)) = 18.6.|The statistical model used for the analysis of those endpoints was an analysis of variance (ANOVA) model on the logarithmic scale (natural logarithm). This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas the other effect was considered as fixed. Abbreviations used: geometric mean (gMean), donepezil (don)||111.68|89.549|
70981531|NCT02698410|141470939|OTHER||||||<|0.0001||||||One-sided p-value estimated using an exact binomial proportion test for one-way tables comparing DCR to 10%.|Binomial proportion test|||Sensitivity Analyisis-2: Comparison of DCR to 10% clinically relevant threshold.||||<0.0001
70981532|NCT01713348|141470955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_DEVIATION|3.3||0.9345|TWO_SIDED|95.0|-1.29|1.19|||t-test, 2 sided|||||1.19|-1.29|0.9345
70981533|NCT01713348|141470955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|STANDARD_DEVIATION|3.5||0.0427|TWO_SIDED|95.0|0.05|2.73|||t-test, 2 sided|||Difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) intervention arm compared to control arm.||2.73|0.05|0.0427
70981534|NCT01713348|141470956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_DEVIATION|1.18||0.8367|TWO_SIDED|95.0|-2.65|2.16|||ANCOVA|Performed for each type of Diabetes and adjusted for baseline Time in Range.||||2.16|-2.65|0.8367
70981535|NCT01713348|141470956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27|STANDARD_DEVIATION|1.05||0.7969|TWO_SIDED|95.0|-1.86|2.4|||ANCOVA|Performed for each type of Diabetes and adjusted for baseline Time in Range.||||2.40|-1.86|0.7969
70981536|NCT01713348|141470957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_DEVIATION|0.6||0.0352|TWO_SIDED|95.0|-0.51|-0.02|||t-test, 2 sided|||||-0.02|-0.51|0.0352
70981537|NCT01713348|141470957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_DEVIATION|0.7||0.0506|TWO_SIDED|95.0|-0.54|0.0|||t-test, 2 sided|||||0.00|-0.54|0.0506
70981538|NCT01713348|141470958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|8.0||0.058|TWO_SIDED|95.0|-6.4|0.1|||t-test, 2 sided|||||0.1|-6.4|0.0580
70981539|NCT01713348|141470958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|STANDARD_DEVIATION|12.0||0.0002|TWO_SIDED|95.0|-13.6|-4.9|||t-test, 2 sided|||||-4.9|-13.6|0.0002
70981540|NCT01713348|141470959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_DEVIATION|0.8||0.058|TWO_SIDED|95.0|-0.59|0.01|||t-test, 2 sided|||||0.01|-0.59|0.0580
70981541|NCT01713348|141470959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_DEVIATION|1.1||0.0002|TWO_SIDED|95.0|-1.24|-0.45|||t-test, 2 sided|||||-0.45|-1.24|0.0002
70981542|NCT01896232|141470960|NON_INFERIORITY_OR_EQUIVALENCE|Etelcalcetide was considered non-inferior to cinacalcet if the upper bound of the 2-sided 95% confidence interval (CI) of the treatment difference (cinacalcet - etelcalcetide) was \< 12%, the prespecified margin for non-inferiority.|Stratified Treatment Difference|-10.48|||||TWO_SIDED|95.0|-17.45|-3.51||||||"The analysis was conducted on the Full Analysis Set (683 participants). Imputation under the non-inferiority null method was applied to participants who did not have PTH data during the EAP.~The Mantel-Haenszel estimator was used to calculate the treatment difference between the proportions (Cinacalcet - Etelcalcetide) stratified by screening PTH level and region."||-3.51|-17.45|
70981543|NCT01896232|141470961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.001|TWO_SIDED|95.0|1.21|2.23|||Cochran-Mantel-Haenszel||The CMH-stratified odds ratio is Etelcalcetide : Cinacalcet.|"Achievement of \> 50% reduction in mean predialysis serum PTH from baseline during the EAP was analyzed using the Cochran-Mantel-Haenszel (CMH) test stratified by screening PTH level and region.~Superiority of etelcalcetide compared with cinacalcet was tested at the 5% significance level (2-sided)."||2.23|1.21|0.001
71097093|NCT03336866|141702997|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 19. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
70981544|NCT01896232|141470962|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.004|TWO_SIDED|95.0|1.16|2.17|||Cochran-Mantel-Haenszel||The CMH stratified odds ratio is Etelcalcetide : Cinacalcet.|"Achievement of \> 30% reduction in mean predialysis serum PTH from baseline during the EAP was analyzed using the Cochran-Mantel-Haenszel test stratified by screening PTH level and region.~Superiority of etelcalcetide compared with cinacalcet was tested at the 5% significance level (2-sided)."||2.17|1.16|0.004
70981545|NCT01896232|141470963|SUPERIORITY_OR_OTHER||Treatment Rate Ratio|1.2|STANDARD_ERROR_OF_MEAN|0.15||0.27|TWO_SIDED|95.0|0.89|1.49|||Generalized Linear Mixed Model||The treatment rate ratio is Etelcalcetide : Cinacalcet.|"Analyzed using a generalized linear mixed model with Poisson regression, including screening value of the number of days of nausea and vomiting, treatment, stratification factors (screening PTH level and region), study weeks, and treatment by study weeks as covariates.~Superiority of etelcalcetide compared with cinacalcet was tested at the 5% significance level (2-sided)."||1.49|0.89|0.27
70981546|NCT01896232|141470964|SUPERIORITY_OR_OTHER||Treatment difference|-3.48|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|95.0|-4.76|-2.21|||||Treatment difference is Etelcalcetide - Cinacalcet.|Analyzed using a repeated measures mixed effects model, including treatment group, randomization stratification factors (screening PTH level and region), study week, and study week by treatment as fixed effects.||-2.21|-4.76|
70981547|NCT01896232|141470965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.83|1.59|||||The CMH-stratified odds ratio is Etelcalcetide : Cinacalcet.|Analyzed using the Cochran-Mantel-Haenszel method stratified by screening PTH level and region.||1.59|0.83|
70981548|NCT01896232|141470966|SUPERIORITY_OR_OTHER||Treatment Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.18|0.12|||||Treatment difference is Etelcalcetide - Cinacalcet.|Analyzed using an analysis of covariance (ANCOVA) model adjusted for screening PTH level and region.||0.12|-0.18|
70981549|NCT01896232|141470967|SUPERIORITY_OR_OTHER||Treatment Rate Ratio|1.2|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|0.86|1.72|||||The treatment rate ratio is Etelcalcetide : Cinacalcet.|This analysis was conducted using a generalized linear mixed model with Poisson regression including screening value of the number of episodes of vomiting, treatment, stratification factors (screening PTH level and region), study weeks, and treatment by study weeks as covariates.||1.72|0.86|
70981550|NCT04425850|141470968|OTHER||||||<|0.0001|||||||Chi-squared|||Chi-squared test on the percentage of subjects who contracted COVID-19 in each arm||||< 0.0001
70981551|NCT00686205|141470975|SUPERIORITY_OR_OTHER||Clinical Specificity|99.94||||||95.0|99.88|99.97|||Binomial Exact|Sample size is based on power of 80%, alpha level of 0.05, using the binomial distribution when comparing to a lower bound of specificity at 99.84.||||99.97|99.88|
70981552|NCT00686205|141470976|SUPERIORITY_OR_OTHER||Clinical Sensitivity|100.0||||||95.0|99.76|100.0|||Binomial Exact|||||100.00|99.76|
70981553|NCT00265941|141470977|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.76|TWO_SIDED|95.0|0.88|1.32|||Log Rank||Reference arm = RT + cisplatin|A total of 945 patients were required (900 analyzable) to test for a 25% reduction in the hazard associated with progression-free survival with 84% statistical power using a one-sided log-rank test at the 0.025 significance level (0.0238 after 3 interim analyses).||1.32|0.88|0.76
70981554|NCT00265941|141470978|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.32|TWO_SIDED|95.0|0.74|1.21|||Log Rank|One-sided log-rank significance level of 0.025|Reference level = RT + cisplatin|Arms were compared using a one-sided log-rank test at the 0.025 significance level.||1.21|0.74|0.32
70981555|NCT00265941|141470979|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.97|TWO_SIDED|95.0|0.99|1.7|||Log Rank|One-sided significance level of 0.025|Reference level = RT + cisplatin|||1.70|0.99|0.97
70981556|NCT00265941|141470984|SUPERIORITY|||||||0.74|||||||Kolmogorov-Smirnov|2-sided significance level of 0.05||3 months||||0.74
70981557|NCT00265941|141470984|SUPERIORITY|||||||0.99|||||||Kolmogorov-Smirnov|2-sided significance level of 0.05||12 months||||0.99
70981558|NCT00265941|141470985|SUPERIORITY|||||||0.13|||||||Chi-squared|2-sided significance level of 0.05||Diet 3-month||||0.13
70981559|NCT00265941|141470985|SUPERIORITY|||||||0.87|||||||Chi-squared|2-sided significance level 0.05||Diet 12-month||||0.87
70981560|NCT00265941|141470985|SUPERIORITY|||||||0.39|||||||Chi-squared|2-sided significance level of 0.05||Eating 3-month||||0.39
70981561|NCT00265941|141470985|SUPERIORITY|||||||0.16|||||||Chi-squared|2-sided significance level of 0.05||Eating 12-month||||0.16
70981562|NCT00265941|141470985|SUPERIORITY|||||||0.81|||||||Chi-squared|2-sided significance level of 0.05||Speech 3-month||||0.81
70981563|NCT00265941|141470985|SUPERIORITY|||||||0.67|||||||Chi-squared|2-sided significance level of 0.05||Speech 12-month||||0.67
70981564|NCT00265941|141470986|SUPERIORITY|||||||0.016|||||||t-test, 2 sided|2-sided significance level of 0.05||||||0.016
70981565|NCT00265941|141470987|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.6|TWO_SIDED|95.0|0.79|1.51|||Log Rank|2-sided significance level = 0.05|Reference level = low EGFR|Progression-free survival is compared between favorable risk and unfavorable risk groups.||1.51|0.79|0.60
70981566|NCT00265941|141470987|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.37|TWO_SIDED|95.0|0.81|1.76|||Log Rank|2-sided significance level = 0.05|Reference level = low EGFR|Overall survival is compared between favorable risk and unfavorable risk groups.||1.76|0.81|0.37
70981567|NCT00265941|141470987|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.76|TWO_SIDED|95.0|0.6|1.46|||Log Rank|2-sided significance level = 0.05|Reference level = low EGFR|Local-regional failure||1.46|0.60|0.76
70981568|NCT00265941|141470988|SUPERIORITY||Hazard Ratio (HR)|0.3||||0.01|TWO_SIDED|95.0|0.12|0.75|||Log Rank|2-sided significance level = 0.05|Reference level = low|Progression-free survival is compared between low and high SUVmax groups.||0.75|0.12|0.01
70981569|NCT00265941|141470988|SUPERIORITY||Hazard Ratio (HR)|0.38||||0.1|TWO_SIDED|95.0|0.12|1.2|||Log Rank|2-sided significance level = 0.05|Reference level = low|Overall survival (OS) is compared between low and high SUVmax groups.||1.20|0.12|0.10
70981570|NCT00265941|141470988|SUPERIORITY||Hazard Ratio (HR)|0.31||||0.04|TWO_SIDED|95.0|0.1|0.97|||Log Rank|2-sided significance level = 0.05|Reference level = low|Loco-regional control (LRC) is compared between low and high SUVmax groups.||0.97|0.10|0.04
70981571|NCT03090191|141471014|SUPERIORITY|Lower bound of confidence interval greater than 20% demonstrate vaccine efficacy.|Vaccine efficacy|31.0|||||TWO_SIDED|96.4|-38.7|66.6|||||Vaccine efficacy(VE)=100\*(1-infection rate ratio\[IRR\]),IRR=calculated ratio of first primary CDI incidence between Clostridium difficile vaccine group and placebo group. 96.4% CI was estimated using Clopper-Pearson-Method.|||66.6|-38.7|
70981572|NCT03090191|141471015|SUPERIORITY|Lower bound of confidence interval greater than 20% demonstrate vaccine efficacy.|Vaccine efficacy|28.6|||||TWO_SIDED|96.4|-28.4|61.0|||||Vaccine efficacy(VE)=100\*(1-infection rate ratio\[IRR\]),IRR=calculated ratio of first primary CDI incidence between Clostridium difficile vaccine group and placebo group. 96.4% CI was estimated using Clopper-Pearson-Method.|||61.0|-28.4|
70981573|NCT03090191|141471024|SUPERIORITY||Vaccine efficacy|11.1|||||TWO_SIDED|98.2|-110.7|62.5|||||VE = 100\*(1 - Hazard Ratio). 98.2% CI was estimated using Proportional Means Model.|||62.5|-110.7|
70981574|NCT03090191|141471025|SUPERIORITY|||||||0.0172|||||||Wilcoxon Rank Sum Test (2-sided)|||||||0.0172
70981575|NCT03090191|141471026|SUPERIORITY||Ratio of proportions|0.0|||||TWO_SIDED|98.2|0.0|0.81||||||||0.81|0.00|
70981576|NCT03090191|141471027|SUPERIORITY||Vaccine efficacy|-69.3|||||TWO_SIDED|98.2|-1533.1|75.6|||||Vaccine efficacy(VE)=100\*(1-infection rate ratio\[IRR\]),IRR=calculated ratio of recurrent CDI incidence between Clostridium difficile vaccine group and placebo group. 98.2% CI was estimated using Clopper-Pearson-Method.|||75.6|-1533.1|
70981577|NCT03090191|141471028|SUPERIORITY||Vaccine efficacy|14.9|||||TWO_SIDED|98.2|-74.6|58.5|||||VE = 100\*(1 - Hazard Ratio). 98.2% CI was estimated using Proportional Means Model|||58.5|-74.6|
70981578|NCT03090191|141471029|SUPERIORITY||Vaccine efficacy|-102.4|||||TWO_SIDED|98.2|-1770.1|67.2|||||VE = 100\*(1 - IRR), where IRR= the calculated ratio of recurrent CDI incidence between the Clostridium difficile vaccine group and the placebo group. 98.2% CI was estimated using Clopper-Pearson-Method.|||67.2|-1770.1|
70981579|NCT03090191|141471030|SUPERIORITY||Vaccine efficacy|12.0|||||TWO_SIDED|98.2|-246.7|78.5|||||Vaccine efficacy(VE)=100\*(1-infection rate ratio\[IRR\]),IRR=calculated ratio of first primary CDI incidence between Clostridium difficile vaccine group and placebo group. 98.2% CI was estimated using Clopper-Pearson-Method.|||78.5|-246.7|
70981580|NCT02432807|141471032|SUPERIORITY|||||||0.2219|||||||Chi-squared|||||||0.2219
70981581|NCT02432807|141471033|SUPERIORITY|||||||0.1817|||||||Chi-squared|||||||0.1817
70981582|NCT03617926|141471062|SUPERIORITY|In case superiority is not proven, non-inferiority is tested. As non-inferiority margin (δ), a 7.5% worse cure rate is regarded as clinically not relevant. The following null hypothesis will be used: H0, NI: pT-pR \< δ, whereby δ = -7.5%. The lower, 95% confidence interval of the difference pT-pR will be used for the test. If H0, NI will be rejected, non-inferiority cannot be shown.||||||0.023||||||A priori treshold p value of 0.05 for statistical significance was set prior to study start.|Chi-squared|||"Efficacy analyses is performed on the ITT population (all subjects who were included and randomized in the study, with available baseline value of the primary endpoint and at least one follow-up visit). All statistical tests are performed at a 5% level of significance. The aim of this analysis is to show superiority for the cure rate of the test product versus a predefined limit of 70%. The following null hypothesis will be tested: H0, prim: pT - pR = 0 and Ha: pT - pR \> 15%~I"||||0.023
70981583|NCT02966314|141471088|SUPERIORITY||Odds Ratio (OR)|18.7||||0.003|TWO_SIDED|95.0|2.77|126.47|||Regression, Logistic|Accounting for repeated measures||||126.47|2.77|0.003
70981584|NCT02966314|141471090|SUPERIORITY||Mean Difference (Final Values)|9.43||||0.03|TWO_SIDED|95.0|1.24|17.63|||Regression, Linear|||||17.63|1.24|0.03
70981585|NCT02966314|141471092|SUPERIORITY||Odds Ratio (OR)|32.8||||0.03|TWO_SIDED|95.0|1.49|720.54|||Regression, Logistic|Accounting for repeated measures||||720.54|1.49|0.03
70981586|NCT02966314|141471094|SUPERIORITY||Risk Ratio (RR)|6.9||||0.005|TWO_SIDED|95.0|1.9|25.3|||Regression, Linear|Accounting for multiple measures, using poisson distribution with natural log link||||25.3|1.9|0.005
70981587|NCT04871815|141471132|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Body Aches||||0.200
70981588|NCT04871815|141471132|SUPERIORITY|||||||0.0326|||||||Wilcoxon (Mann-Whitney)|||Headaches||||0.0326
70981589|NCT04871815|141471132|SUPERIORITY|||||||0.0043|||||||Wilcoxon (Mann-Whitney)|||Coughing/Sneezing||||0.0043
70981590|NCT04871815|141471132|SUPERIORITY|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||Trouble Breathing||||0.0003
70981591|NCT04871815|141471132|SUPERIORITY|||||||0.3714|||||||Wilcoxon (Mann-Whitney)|||Congestion||||0.3714
70981592|NCT04871815|141471132|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Fatigue||||0.300
70981593|NCT04871815|141471132|SUPERIORITY|||||||0.2286|||||||Wilcoxon (Mann-Whitney)|||Loss of Smell/Taste||||0.2286
70981594|NCT04871815|141471132|SUPERIORITY|||||||0.999|||||||Wilcoxon (Mann-Whitney)|||Anxiety||||0.999
70981595|NCT04871815|141471133|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70981596|NCT04871815|141471134|SUPERIORITY|||||||0.1963|||||||ANOVA|||||||0.1963
70981597|NCT04871815|141471135|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
70981598|NCT04871815|141471135|SUPERIORITY|||||||0.0008||||||Tukey's Multiple comparison test (p-value is adjusted for multiple comparisons)|Tukey's HSD|||Day 1 baseline (day 1 of study) vs Day 1 treatment (day 7 of study).||||0.0008
70981599|NCT04871815|141471135|SUPERIORITY||||||<|0.0001||||||Tukey's Multiple comparison test (p-value is adjusted for multiple comparisons)|Tukey's HSD|||Day 1 baseline (day 1 of study) vs Day 7 treatment (day 14 of study).||||<0.0001
70981600|NCT04871815|141471135|SUPERIORITY|||||||0.0114||||||Tukey's Multiple comparison test (p-value is adjusted for multiple comparisons)|Tukey's HSD|||Day 7 baseline (day 7 of study) vs Day 1 treatment (day 7 of study).||||0.0114
70981601|NCT04871815|141471135|SUPERIORITY||||||<|0.0001||||||Tukey's Multiple comparison test (p-value is adjusted for multiple comparisons)|Tukey's HSD|||Day7 baseline (day 7 of study) vs Day 7 treatment (day 14 of study)||||<0.0001
70981602|NCT02120417|141471136|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.932||||0.762|TWO_SIDED|80.0|0.694|1.252|||Log Rank|The P-value was analyzed by Log-Rank Test stratified by Hormone Receptor Status.||||1.252|0.694|0.762
70981603|NCT03040154|141471158|SUPERIORITY||Odds Ratio (OR)|2.67||||0.006|TWO_SIDED|95.0|1.33|5.35|||Regression, Logistic|||||5.35|1.33|0.006
70981604|NCT03542682|141471161|SUPERIORITY||Mean Difference (Final Values)|-55.67|||||TWO_SIDED|95.0|-124.63|13.3|||Mixed Models Analysis|The model adjusted for order of the clamps and accounting for within subject correlation.||||13.30|-124.63|
70981605|NCT03542682|141471163|SUPERIORITY||Mean Difference (Final Values)|0.96|||||TWO_SIDED|95.0|-1.1|3.02|||Mixed Models Analysis|The model adjusted for order of the clamps and accounting for within subject correlation.||||3.02|-1.10|
70981606|NCT03542682|141471164|SUPERIORITY||Mean Difference (Final Values)|131.85|||||TWO_SIDED|95.0|-246.7|510.41|||Mixed Models Analysis|The model adjusted for order of the clamps and accounting for within subject correlation.||||510.41|-246.70|
70981607|NCT01672892|141471186|SUPERIORITY|||||||0.0476|||||||t-test, 1 sided|||Since there is no prior data using this tool in this patient population, an effect size of 0.4 was chosen to calculate sample size. Based on a two-sample t-test with one interim look and a two-sided alpha=0.05, a sample size of 225 is needed to achieve 85% statistical power. Assuming an attrition rate of 10% and noncompliance of 10%, 281 patients were required in order to ensure 225 evaluable patients for the primary endpoint analysis.||||0.0476
70981608|NCT01672892|141471187|SUPERIORITY|||||||0.4338|||||||Binomial test of proportions|2-sided significance level = 0.05||||||0.4338
70981609|NCT01672892|141471188|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|2-sided significance level of 0.05||Week 3 of RT||||0.04
70981610|NCT01672892|141471188|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|2-sided significance level of 0.05||Week 5 of RT||||0.03
70981611|NCT01672892|141471188|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|2-sided significance level of 0.05||4-6 weeks post-RT||||0.41
70981612|NCT01672892|141471189|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|2-sided significance level = 0.05||FACT-G total score - 5 weeks||||0.54
70981613|NCT01672892|141471189|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|FACT-G total score - 4-6 weeks post RT||FACT-G total score - 4-6 weeks post RT||||0.72
70981614|NCT01672892|141471189|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|2-sided significance level = 0.05||FACT-Cx subscale score - 5 weeks||||0.01
70981615|NCT01672892|141471189|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|2-sided significance level = 0.05||FACT-Cx subscale score - 4-6 weeks post RT||||0.45
70981616|NCT01672892|141471189|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|2-sided significance level = 0.0125||Physical subscale score - 5 weeks||||0.03
70981617|NCT01672892|141471189|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|2-sided significance level = 0.0125||Physical subscale score - 4-6 weeks post RT||||0.9
70981618|NCT01672892|141471189|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|2-sided significance level = 0.0125||Functional subscale score - 5 weeks||||0.55
70981619|NCT01672892|141471189|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|2-sided significance level = 0.0125||Functional subscale score - 4-6 weeks post RT||||0.35
70981620|NCT01672892|141471189|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|2-sided significance level = 0.0125||Emotional subscale score - 5 weeks||||0.66
70981621|NCT01672892|141471189|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|2-sided significance level = 0.0125||Emotional subscale score - 4-6 weeks post RT||||0.09
70981622|NCT01672892|141471189|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|2-sided significance level = 0.0125||Social subscale score - 5 weeks||||0.66
70981623|NCT01672892|141471189|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|2-sided significance level = 0.0125||Social subscale score - 4-6 weeks post RT||||0.35
70981624|NCT01672892|141471190|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|2-sided significance level = 0.05||5 weeks||||0.61
70981625|NCT01672892|141471190|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|2-sided significance level = 0.05||4-6 weeks post-RT||||0.67
70981626|NCT01672892|141471191|SUPERIORITY|||||||0.81|||||||Gray's test|Two-sided significance level = 0.05||||||0.81
70981627|NCT01672892|141471192|SUPERIORITY||Hazard Ratio (HR)|1.39||||0.21|TWO_SIDED|95.0|0.82|2.35|||Log Rank|Two-side significance level = 0.05|Reference level = Intensity-Modulated Radiation Therapy|||2.35|0.82|0.21
70981628|NCT01672892|141471193|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.53|TWO_SIDED|95.0|0.32|1.79|||Log Rank|Two-sided significance level = 0.05|Reference level = Intensity-Modulated Radiation Therapy|||1.79|0.32|0.53
70981629|NCT01672892|141471196|OTHER||||||<|0.0001|||||||nonparametric one-sample t-test|||Baseline||||<0.0001
70981630|NCT01672892|141471196|OTHER||||||<|0.0001|||||||nonparametric one-sample t-test|||Week 5||||<0.0001
70981631|NCT01672892|141471197|OTHER||||||<|0.0001|||||||One-sample t-test|||Bowel domain at baseline||||<0.0001
70981632|NCT01672892|141471197|OTHER||||||<|0.0001|||||||One-sample t-test|||Bowel domain at week 5||||<0.0001
70981633|NCT01672892|141471197|OTHER||||||<|0.0001|||||||One-sample t-test|||Urinary domain at baseline||||<0.0001
70981634|NCT01672892|141471197|OTHER||||||<|0.0001|||||||One-sample t-test|||Urinary domain at week 5||||<0.0001
70981635|NCT01672892|141471198|OTHER||||||<|0.0001|||||||Paired t-test|||Bowel domain||||<0.0001
70981636|NCT01672892|141471198|OTHER||||||<|0.0001|||||||Paired t-test|||Urinary domain||||<0.0001
70981637|NCT02559505|141471205|OTHER|||||||0.005||||||p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.005
70981638|NCT02559505|141471205|OTHER|||||||0.024||||||p-value for NP reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.024
70981639|NCT02559505|141471206|OTHER|||||||0.408||||||p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.408
70981640|NCT02559505|141471206|OTHER|||||||0.004||||||p-value for NP reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.004
70981641|NCT02559505|141471207|OTHER|||||||0.991||||||p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.991
71097094|NCT03336866|141702997|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 26. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
71097095|NCT03336866|141702998|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 5 (primary). Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
70981642|NCT02559505|141471207|OTHER|||||||0.334||||||p-value for NP reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.334
70981643|NCT02559505|141471208|OTHER|||||||0.226||||||p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.226
70981644|NCT02559505|141471208|OTHER|||||||0.036||||||p-value for NP reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.036
70981645|NCT02559505|141471209|OTHER|||||||0.68||||||p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.680
70981646|NCT02559505|141471209|OTHER|||||||0.002||||||p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.002
70981647|NCT01584024|141471213|SUPERIORITY||||||=|0.003|||||||McNemar|||||||=0.003
70981648|NCT01584024|141471214|SUPERIORITY||||||=|0.17|||||||McNemar|||||||=0.17
70981649|NCT00893789|141471241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8336||95.0||||The analyses performed were not done in accordance to the study protocol as the study was terminated early and therefore the analyses done were underpowered, no adjustments for multiple comparisons (or step-down analysis rules) were applied.|ANCOVA|||"P-value for Change from Baseline at Endpoint."||||0.8336
70981650|NCT00893789|141471241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0514||95.0||||The analyses performed were not done in accordance to the study protocol as the study was terminated early and therefore the analyses done were underpowered, no adjustments for multiple comparisons (or step-down analysis rules) were applied.|ANCOVA|||"P-value for Change from Baseline at Endpoint."||||0.0514
70981651|NCT00893789|141471241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||The analyses performed were not done in accordance to the study protocol as the study was terminated early and therefore the analyses done were underpowered, no adjustments for multiple comparisons (or step-down analysis rules) were applied.|ANCOVA|||"P-value for Change from Baseline at Endpoint."||||0.0010
70981652|NCT00893789|141471242|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7884||95.0|||||Pearson's chi-squared|||||||0.7884
70981653|NCT00893789|141471242|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2359||95.0|||||Pearson's chi-squared|||||||0.2359
70981654|NCT00893789|141471242|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4401||95.0|||||Pearson's chi-squared|||||||0.4401
70981655|NCT04419506|141471272|OTHER||Posterior difference|88.4|||||TWO_SIDED|95.0|29.5|154.2|||||Difference calculated as BI 1015550 - Placebo|Adjusted means in the placebo group were combined with the meta-analytic predictive priors derived based on the clinical trials in the nintedanib clinical development program in IPF. In order to evaluate the treatment effects, the posterior distribution for the treatment difference of BI 1015550 versus placebo with respect to the primary endpoint was used. The median of the posterior distribution for the treatment difference (and 95% credible intervals) was calculated.||154.2|29.5|
70981656|NCT04419506|141471272|OTHER||Posterior difference|62.4|||||TWO_SIDED|95.0|6.3|125.5|||||Difference calculated as BI 1015550 - Placebo|Adjusted means in the placebo group were combined with the meta-analytic predictive priors derived based on the clinical trials in the nintedanib clinical development program in IPF. In order to evaluate the treatment effects, the posterior distribution for the treatment difference of BI 1015550 versus placebo with respect to the primary endpoint was used. The median of the posterior distribution for the treatment difference (and 95% credible intervals) was calculated.||125.5|6.3|
70981657|NCT02513940|141471274|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
70981658|NCT02513940|141471275|SUPERIORITY|||||||0.001||||||"Pairwise comparisons:~Testosterone vs placebo: p=0.008 Progesterone vs placebo: p=0.73 Testosterone vs progesterone: p=0.0008"|Mixed Models Analysis|||||||0.001
70981659|NCT02513940|141471276|SUPERIORITY|||||||0.6|||||||Mixed Models Analysis|Repeated measures ANOVA||||||0.60
70981660|NCT02513940|141471277|SUPERIORITY|||||||0.0003||||||"Pairwise comparisons:~Testosterone vs placebo: p = 0.0001 Progesterone vs placebo: p = 0.25 Testosterone vs progesterone: p = 0.002"|Mixed Models Analysis|Repeated measures ANOVA||||||0.0003
70981661|NCT02513940|141471278|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||Fatigue||||>0.99
70981662|NCT02513940|141471278|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||Rash at gel application site||||>0.99
70981663|NCT01021007|141471348|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANCOVA|ANCOVA method using treatment as the factor and the baseline score as a covariate||The null hypothesis states that there is no difference between groups.||||0.005
70981664|NCT01021007|141471349|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|ANCOVA method using treatment as the factor and the baseline score as a covariate||The null hypothesis states that there is no difference between groups.||||0.05
70981665|NCT01021007|141471350|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|ANCOVA method using treatment as the factor and the baseline score as a covariate||The null hypothesis states that there is no difference between groups.||||0.05
70981666|NCT02015819|141471351|OTHER||||||||||||||||||MFD was determined to be 1.5x10\^8 in combination with oral 5-FC 37.5 mg/kg and leucovorin 25 mg every 6 hours for 7 days.|||
71097096|NCT03336866|141702998|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 12. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
70981667|NCT00087438|141471374|SUPERIORITY_OR_OTHER|||||||0.013||||||Test statistic = \[ln(estimated hazard rate) - ln(hypothesized hazard rates)\] / \[1/square root (number of patients with local progression by two years\]. Reject null hypothesis at an alpha level of 0.05 if test statistics is less than -1.645.|z-test, one-sided|||Null hypothesis = 60% two-year local control (0.02128/mo. hazard rate); alternative = 80% (0.0093/mo.) assuming at least approximately exponential distribution of time to local progression. Using the asymptotic properties of the ratio of the logarithms of hazard rates, less than 18 cases of local progression were required for a Type I error rate of 0.05 with 80% power to detect a difference in local control rates at least this large. Hazard rate estimated using life table two-year estimates.||||0.013
70981668|NCT00811252|141471390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.32|STANDARD_ERROR_OF_MEAN|1.01||0.0011|TWO_SIDED|95.0|-5.31|-1.34||Since p-value \<0.05, hierarchically testing continued|ANCOVA||A statistical testing strategy was defined a priori for a single dose of vortioxetine that was tested versus placebo in the primary and key secondary efficacy analyses.|As soon as an endpoint was non-significant at the 0.05 level of significance, the testing procedure was stopped for all subsequent endpoints.||-1.34|-5.31|0.0011
70981669|NCT00811252|141471390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.48|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|95.0|-7.5|-3.46||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||-3.46|-7.50|<0.0001
70981670|NCT00811252|141471391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.13|STANDARD_ERROR_OF_MEAN|0.94||0.024|TWO_SIDED|95.0|-3.98|-0.28||Since p-value \<0.05, hierarchically testing continued|ANCOVA||A statistical testing strategy was defined a priori for a single dose of vortioxetine that was tested versus placebo in the primary and key secondary efficacy analyses.|As soon as an endpoint was non-significant at the 0.05 level of significance, the testing procedure was stopped for all subsequent endpoints.||-0.28|-3.98|0.0240
70981671|NCT00811252|141471391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.22|STANDARD_ERROR_OF_MEAN|0.96|<|0.0001|TWO_SIDED|95.0|-6.1|-2.34||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||-2.34|-6.10|<0.0001
70981672|NCT00811252|141471392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.06|STANDARD_ERROR_OF_MEAN|0.85||0.2134|TWO_SIDED|95.0|-2.72|0.61||Since p-value \>0.05, hierarchically testing stopped here.|ANCOVA|||||0.61|-2.72|0.2134
70981673|NCT00811252|141471392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|0.86||0.0002|TWO_SIDED|95.0|-4.99|-1.6||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||-1.60|-4.99|0.0002
70981674|NCT00811252|141471393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.7||0.6879|TWO_SIDED|95.0|-1.67|1.1||A nominal p-value is provided.|ANCOVA|||||1.10|-1.67|0.6879
71097097|NCT03336866|141702998|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 19. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
70981675|NCT00811252|141471393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.72||0.0827|TWO_SIDED|95.0|-2.65|0.16||A nominal p-value is provided.|ANCOVA|||||0.16|-2.65|0.0827
70981676|NCT00811252|141471394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.55||0.4482|TWO_SIDED|95.0|-1.49|0.66||A nominal p-value is provided.|ANCOVA|||||0.66|-1.49|0.4482
70981677|NCT00811252|141471394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.56||0.7971|TWO_SIDED|95.0|-0.95|1.24||A nominal p-value is provided.|ANCOVA|||||1.24|-0.95|0.7971
70981678|NCT00811252|141471395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.29|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|95.0|-6.32|-2.26||A nominal p-value is provided. No correction for multiplicity was made.|ANCOVA|||||-2.26|-6.32|<0.0001
70981679|NCT00811252|141471396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35|STANDARD_ERROR_OF_MEAN|0.74||0.0015|TWO_SIDED|95.0|-3.8|-0.91||A nominal p-value is provided. No correction for multiplicity was made.|ANCOVA|||||-0.91|-3.80|0.0015
70981680|NCT00811252|141471397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.88|-0.32||A nominal p-value is provided. No correction for multiplicity was made.|ANCOVA|||||-0.32|-0.88|<0.0001
70981681|NCT00811252|141471398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.82|-0.31||A nominal p-value is provided. No correction for multiplicity was made.|ANCOVA|||||-0.31|-0.82|<0.0001
71097098|NCT03336866|141702998|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 26. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
70981682|NCT00811252|141471399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.23||0.0552|TWO_SIDED|95.0|-0.88|0.01||A nominal p-value is provided. No correction for multiplicity was made.|ANCOVA|||||0.01|-0.88|0.0552
70981683|NCT00811252|141471400|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.0008|TWO_SIDED|95.0|0.26|0.7||A nominal p-value is provided. No correction for multiplicity was made.|Regression, Logistic|||||0.70|0.26|0.0008
70981684|NCT00811252|141471401|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.009|TWO_SIDED|95.0|0.27|0.83||A nominal p-value is provided. No correction for multiplicity was made.|Regression, Logistic|||||0.83|0.27|0.0090
70981685|NCT01486264|141471403|NON_INFERIORITY|Analysis of covariance (ANCOVA) model adjusted for the baseline TWSTRS Severity subscale score, was used to test the non-inferiority of Short Flex versus Long Flex treatment. Non-inferiority margin delta equal to (=) 2 points.|Least Square (LS) Mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-2.9|0.1||||||||0.1|-2.9|
70981686|NCT00613626|141471492|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|22.718||0.1|ONE_SIDED|90.0|||||Log Rank|||A one-sided log rank test with an overall sample size of 68 subjects (of which 34 are in arm A and 34 are in arm B) achieves 80% power at a 0.10 significance level to detect a difference of 3 months in PFS between 4 month median PFS and 7 month median PFS.||||0.10
70981687|NCT00613626|141471492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9518|TWO_SIDED|||||P-Value (2-tailed) is calculated based on the unstratified log-rank test.|Log Rank|Degrees of freedom=1||||||0.9518
70981688|NCT00613626|141471494|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2533|TWO_SIDED||||||Difference in Rates|P-value (two-tailed) is calculated based on an unadjusted, normal-distribution approximation for the difference in rates.||||||0.2533
70981689|NCT00613626|141471495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.872|TWO_SIDED||||||Difference in Rates|||||||0.8720
70981690|NCT00613626|141471496|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4577|TWO_SIDED||||||Log Rank|||||||0.4577
70981691|NCT00613626|141471497|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.05|||||TWO_SIDED|95.0|||||||Survival analysis of VEGF variants using cox proportional hazard analysis in arm A and arm B.|Data was not collected for safety lead-in participants and these participants were not included in the analysis.||||
70981692|NCT00613626|141471497|SUPERIORITY_OR_OTHER_LEGACY||Logistic Regression Analysis|0.05|||||TWO_SIDED|95.0|||||||Objective Response Analysis of VEGF variants using Logistic Regression Analysis in arm A and arm B|||||
70981693|NCT05480514|141471521|SUPERIORITY|A superiority margin of 0.90 was used. Superiority was concluded if the lower bound of the 95% central posterior credible interval was above 0.90.|Mean Posterior Proportion|0.9741|STANDARD_DEVIATION|0.01244|||TWO_SIDED|95.0|0.9445|0.9926|||Bayesian beta-binomial model|||||0.9926|0.9445|
71097099|NCT03336866|141702998|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 5 (primary). Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
71097100|NCT03336866|141702998|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 12. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
71035845|NCT02635750|141580648|OTHER||Adjusted gMean ratio(%)|98.38|||||TWO_SIDED|90.0|93.413|103.6|||||Ratio of donepezil 5mg with BI 409306 100mg and donepezil 5mg alone (BI 409306+don / don). Intra-individual coefficient of variation (gCV (%)) = 7.7.|"The PK endpoints were log transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'periods' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.~Abbreviations used: geometric mean (gMean), donepezil (don)"||103.60|93.413|
71035846|NCT00835705|141580665|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|103.03||||||90.0|98.4|107.88|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||107.88|98.40|
71035847|NCT00835705|141580666|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|98.43||||||90.0|96.71|100.18|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||100.18|96.71|
71035848|NCT00835705|141580667|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|98.29||||||90.0|96.58|100.03|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||100.03|96.58|
71035849|NCT00835705|141580668|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|103.16||||||90.0|95.33|111.64|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||111.64|95.33|
71035850|NCT00835705|141580669|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|103.79||||||90.0|95.75|112.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||112.50|95.75|
71097101|NCT03336866|141702998|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 19. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
70981694|NCT00457639|141471532|SUPERIORITY||Mean Difference (Net)|13.8||||0.42|TWO_SIDED|95.0|-19.7|61.1|||Mixed Models Analysis|||||61.1|-19.7|0.42
70981695|NCT00457639|141471533|SUPERIORITY||Mean Difference (Final Values)|11.4||||0.45|TWO_SIDED|95.0|-17.7|50.8|||Mixed Models Analysis|||||50.8|-17.7|0.45
70981696|NCT04885257|141471534|SUPERIORITY|||||||0.896|||||||Wilcoxon (Mann-Whitney)|||||||0.896
71035851|NCT00835705|141580670|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|104.26||||||90.0|95.76|113.52|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||113.52|95.76|
71035852|NCT01592240|141580671|SUPERIORITY_OR_OTHER||Adjusted mean difference|-34.28|||<|0.001|TWO_SIDED|95.0|-45.06|-23.5|||Mixed models repeated measures analysis|||||-23.50|-45.06|<0.001
71035853|NCT01592240|141580671|SUPERIORITY_OR_OTHER||Adjusted mean difference|-45.07|||<|0.001|TWO_SIDED|95.0|-55.93|-34.21|||Mixed models repeated measures analysis|||||-34.21|-55.93|<0.001
70981697|NCT01200433|141471549|NON_INFERIORITY_OR_EQUIVALENCE|"We tested a joint hypothesis that dexmedetomidine was noninferior to propofol both in terms of cerebral blood flow velocity and brain oxygenation during DBS surgery.~A total of 44 patients provided a 90% power at the 0.05 significance level to detect noninferiority of dexmedetomidine to propofol using a noninferiority ratio of geometric means of 0.80, assuming a coefficient of variation of 25% for each of the 2 primary outcomes. Both outcomes were expected to follow a log-normal distribution."|Ratio of Geometric Means|0.94||||0.011|TWO_SIDED|90.0|0.84|1.05|||t-test, 1 sided||Dexmedetomidine vs. propofol|||1.05|0.84|0.011
70981698|NCT01200433|141471550|NON_INFERIORITY_OR_EQUIVALENCE|"We tested a joint hypothesis that dexmedetomidine was noninferior to propofol both in terms of cerebral blood flow velocity and brain oxygenation during DBS surgery.~A total of 44 patients provided a 90% power at the 0.05 significance level to detect noninferiority of dexmedetomidine to propofol using a noninferiority ratio of geometric means of 0.80, assuming a coefficient of variation of 25% for each of the 2 primary outcomes. Both outcomes were expected to follow a log-normal distribution."|Ratio of Geometric Means|0.99|||<|0.001|TWO_SIDED|90.0|0.96|1.02|||t-test, 1 sided||Dexmedetomidine vs. propofol|||1.02|0.96|< 0.001
71035854|NCT01592240|141580671|SUPERIORITY_OR_OTHER||Adjusted mean difference|-53.42|||<|0.001|TWO_SIDED|95.0|-64.14|-42.7|||Mixed models repeated measures analysis|||||-42.70|-64.14|<0.001
71035855|NCT01592240|141580671|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.58|||<|0.001|TWO_SIDED|95.0|-40.49|-14.67|||Mixed models repeated measures analysis|||||-14.67|-40.49|<0.001
71035856|NCT01592240|141580671|SUPERIORITY_OR_OTHER||Adjusted mean difference|-44.85|||<|0.001|TWO_SIDED|95.0|-57.65|-32.05|||Mixed models repeated measures analysis|||||-32.05|-57.65|<0.001
71035857|NCT01592240|141580672|SUPERIORITY_OR_OTHER||Adjusted mean difference|-28.41|||<|0.001|TWO_SIDED|95.0|-39.15|-17.67|||Mixed models repeated measures analysis|||||-17.67|-39.15|<0.001
71035858|NCT01592240|141580672|SUPERIORITY_OR_OTHER||Adjusted mean difference|-43.21|||<|0.001|TWO_SIDED|95.0|-53.9|-32.51|||Mixed models repeated measures analysis|||||-32.51|-53.90|<0.001
71035859|NCT01592240|141580672|SUPERIORITY_OR_OTHER||Adjusted mean difference|-41.03|||<|0.001|TWO_SIDED|95.0|-51.66|-30.41|||Mixed models repeated measures analysis|||||-30.41|-51.66|<0.001
71035860|NCT01592240|141580672|SUPERIORITY_OR_OTHER||Adjusted mean difference|-23.77|||<|0.001|TWO_SIDED|95.0|-33.7|-13.84|||Mixed models repeated measures analysis|||||-13.84|-33.70|<0.001
71097102|NCT00541775|141703009|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<=|0.001||95.0|-0.7|-0.32|||ANCOVA|Analysis of covariance with a term for treatment, and a covariate for baseline value.||||-0.32|-0.70|<=0.001
71097103|NCT00541775|141703010|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.8|STANDARD_ERROR_OF_MEAN|5.0|<=|0.001||95.0|-27.6|-8.1|||ANCOVA|Analysis of covariance with a term for treatment, and a covariate for baseline value.||||-8.1|-27.6|<=0.001
71097104|NCT00541775|141703011|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-30.5|STANDARD_ERROR_OF_MEAN|7.9|<=|0.001||95.0|-46.0|-15.0|||ANCOVA|Analysis of covariance with a term for treatment, and a covariate for baseline value.||||-15.0|-46.0|<=0.001
70981699|NCT01200433|141471552|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|99.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|0|<0.001
70981700|NCT01200433|141471553|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|1.0||||0.91|TWO_SIDED|99.0|0.86|1.18|||Wilcoxon (Mann-Whitney)|||||1.18|0.86|0.91
71035861|NCT01592240|141580672|SUPERIORITY_OR_OTHER||Adjusted mean difference|-30.36|||<|0.001|TWO_SIDED|95.0|-40.24|-20.49|||Mixed models repeated measures analysis|||||-20.49|-40.24|<0.001
71035862|NCT01592240|141580673|SUPERIORITY_OR_OTHER||Adjusted mean difference|-35.0|||<|0.001|TWO_SIDED|95.0|-44.91|-25.1|||Mixed models repeated measures analysis|||Week 12||-25.10|-44.91|<0.001
71035863|NCT01592240|141580673|SUPERIORITY_OR_OTHER||Adjusted mean difference|-42.32|||<|0.001|TWO_SIDED|95.0|-52.3|-32.33|||Mixed models repeated measures analysis|||Week 12||-32.33|-52.30|<0.001
71035864|NCT01592240|141580673|SUPERIORITY_OR_OTHER||Adjusted mean difference|-53.12|||<|0.001|TWO_SIDED|95.0|-62.97|-43.27|||Mixed models repeated measures analysis|||Week 12||-43.27|-62.97|<0.001
71035865|NCT01592240|141580673|SUPERIORITY_OR_OTHER||Adjusted mean difference|-26.96|||<|0.001|TWO_SIDED|95.0|-38.25|-15.67|||Mixed models repeated measures analysis|||Week 12||-15.67|-38.25|<0.001
71035866|NCT01592240|141580673|SUPERIORITY_OR_OTHER||Adjusted mean difference|-41.13|||<|0.001|TWO_SIDED|95.0|-52.32|-29.94|||Mixed models repeated measures analysis|||Week 12||-29.94|-52.32|<0.001
71035867|NCT01592240|141580673|SUPERIORITY_OR_OTHER||Adjusted mean difference|-29.09|||<|0.001|TWO_SIDED|95.0|-38.42|-19.77|||Mixed models repeated measures analysis|||Week 24||-19.77|-38.42|<0.001
71035868|NCT01592240|141580673|SUPERIORITY_OR_OTHER||Adjusted mean difference|-40.14|||<|0.001|TWO_SIDED|95.0|-49.43|-30.86|||Mixed models repeated measures analysis|||Week 24||-30.86|-49.43|<0.001
71035869|NCT01592240|141580673|SUPERIORITY_OR_OTHER||Adjusted mean difference|-39.16|||<|0.001|TWO_SIDED|95.0|-48.37|-29.94|||Mixed models repeated measures analysis|||Week 24||-29.94|-48.37|<0.001
71097105|NCT00032487|141703012|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis tested was for equivalence. We assumed 86% power with 21% of effect size and the sample size 1700 with 5% drop out rate.|Cox Proportional Hazard|0.79|||<|0.05|TWO_SIDED|95.0|0.79|0.99|||Log Rank|||It was hypothesized 21% reduction in intensive glycemic control group compared to standard control group on primary cardiovascular composite outcomes.||.99|.79|<0.05
71097106|NCT05890586|141703144|SUPERIORITY|The posterior was based on a covariate adjusted Cox proportional hazards regression with skeptical prior. The baseline hazard was a degree 5 M-spline function.|Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.86|1.07|||||Hazard ratios greater than one favored the active intervention for a faster time to recovery.|||1.07|0.86|
71097107|NCT05890586|141703145|SUPERIORITY|No hypothesis test or decision rule was evaluated.|Hazard Ratio (HR)|0.3|||||TWO_SIDED|95.0|0.03|2.88|||||Low event rate precluded covariate adjustment.|||2.88|0.03|
70981701|NCT01200433|141471555|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.9||||0.02|TWO_SIDED|99.0|-4.1|0.2|||Wilcoxon (Mann-Whitney)|||||0.2|-4.1|0.02
71035870|NCT01592240|141580673|SUPERIORITY_OR_OTHER||Adjusted mean difference|-23.79|||<|0.001|TWO_SIDED|95.0|-32.88|-14.7|||Mixed models repeated measures analysis|||Week 24||-14.70|-32.88|<0.001
71035871|NCT01592240|141580673|SUPERIORITY_OR_OTHER||Adjusted mean difference|-29.08|||<|0.001|TWO_SIDED|95.0|-38.13|-20.04|||Mixed models repeated measures analysis|||Week 24||-20.04|-38.13|<0.001
71035872|NCT01592240|141580674|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.64||||0.281|TWO_SIDED|95.0|-1.35|4.63|||Mixed models repeated measures analysis|||Week 12||4.63|-1.35|0.281
71035873|NCT01592240|141580674|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.73||||0.251|TWO_SIDED|95.0|-1.24|4.71|||Mixed models repeated measures analysis|||Week 12||4.71|-1.24|0.251
71035874|NCT01592240|141580674|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.53||||0.724|TWO_SIDED|95.0|-2.43|3.5|||Mixed models repeated measures analysis|||Week 12||3.50|-2.43|0.724
71097108|NCT05890586|141703148|SUPERIORITY|No hypothesis test or decision rule was evaluated.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.6|1.7|||||Hazard ratios less than one favor the active intervention of inhaled fluticasone furoate. The interval is a highest density credible interval.|The posterior was based on a covariate adjusted Cox proportional hazards regression with skeptical prior. The baseline hazard was a degree 5 M-spline function.||1.7|0.6|
71097109|NCT05890586|141703149|SUPERIORITY|No hypothesis test or decision rule was evaluated.|Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.74|1.98|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|Adjustment variables are randomization assignment, age (as restricted cubic spline), sex, duration of symptoms prior to receipt of study drug, calendar time (as restricted cubic spline), vaccination status, geographic region (Northeast, Midwest, South, West), call center indicator, and baseline symptom severity.||1.98|0.74|
70981702|NCT01200433|141471556|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|||>|0.99|TWO_SIDED|99.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|>0.99
70981703|NCT01756157|141471602|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.61||||0.0523|TWO_SIDED|95.0|-1.23|0.01|||Paired t-test, 2 sided|||||0.01|-1.23|0.0523
70981704|NCT02907944|141471618|SUPERIORITY||Odds Ratio (OR)|1.09||||0.55|TWO_SIDED|95.0|0.82|1.45|||Generalized Estimating Equation|||||1.45|0.82|0.55
70981705|NCT02907944|141471618|SUPERIORITY||Odds Ratio (OR)|1.76||||0.09|TWO_SIDED|95.0|0.92|3.37|||Generalized Estimating Equation|||||3.37|0.92|0.09
70981706|NCT02907944|141471618|SUPERIORITY||Odds Ratio (OR)|1.4||||0.001|TWO_SIDED|95.0|1.14|1.71|||Generalized Estimating Equation|||||1.71|1.14|0.001
70981707|NCT02907944|141471619|SUPERIORITY||Odds Ratio (OR)|1.08||||0.59|TWO_SIDED|95.0|0.81|1.45|||Generalized Estimating Equation|||||1.45|0.81|0.59
71035875|NCT01592240|141580674|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.45||||0.007|TWO_SIDED|95.0|1.21|7.7|||Mixed models repeated measures analysis|||Week 12||7.70|1.21|0.007
71035876|NCT01592240|141580674|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.86||||0.019|TWO_SIDED|95.0|0.63|7.09|||Mixed models repeated measures analysis|||Week 12||7.09|0.63|0.019
71035877|NCT01592240|141580674|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.72||||0.225|TWO_SIDED|95.0|-1.07|4.51|||Mixed models repeated measures analysis|||Week 24||4.51|-1.07|0.225
71035878|NCT01592240|141580674|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.79||||0.571|TWO_SIDED|95.0|-1.97|3.56|||Mixed models repeated measures analysis|||Week 24||3.56|-1.97|0.571
71035879|NCT01592240|141580674|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.49||||0.725|TWO_SIDED|95.0|-2.25|3.24|||Mixed models repeated measures analysis|||Week 24||3.24|-2.25|0.725
71097110|NCT05890586|141703150|SUPERIORITY|No hypothesis test or decision rule was evaluated.|Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.53|2.06|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|Adjustment variables are randomization assignment, age (as restricted cubic spline), sex, duration of symptoms prior to receipt of study drug, calendar time (as restricted cubic spline), vaccination status, geographic region (Northeast, Midwest, South, West), call center indicator, and baseline symptom severity.||2.06|0.53|
71035880|NCT01592240|141580674|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.01||||0.268|TWO_SIDED|95.0|-1.56|5.57|||Mixed models repeated measures analysis|||Week 24||5.57|-1.56|0.268
71035881|NCT01592240|141580674|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.01||||0.996|TWO_SIDED|95.0|-3.55|3.54|||Mixed models repeated measures analysis|||Week 24||3.54|-3.55|0.996
71035882|NCT01592240|141580675|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.41||||0.246|TWO_SIDED|95.0|-2.38|9.21|||Mixed models repeated measures analysis|||Week 12||9.21|-2.38|0.246
71035883|NCT01592240|141580675|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.62||||0.371|TWO_SIDED|95.0|-3.14|8.38|||Mixed models repeated measures analysis|||Week 12||8.38|-3.14|0.371
71035884|NCT01592240|141580675|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.35||||0.643|TWO_SIDED|95.0|-4.4|7.1|||Mixed models repeated measures analysis|||Week 12||7.10|-4.40|0.643
71035885|NCT01592240|141580675|SUPERIORITY_OR_OTHER||Adjusted mean difference|7.66||||0.018|TWO_SIDED|95.0|1.33|13.99|||Mixed models repeated measures analysis|||Week 12||13.99|1.33|0.018
71035886|NCT01592240|141580675|SUPERIORITY_OR_OTHER||Adjusted mean difference|6.52||||0.043|TWO_SIDED|95.0|0.22|12.83|||Mixed models repeated measures analysis|||Week 12||12.83|0.22|0.043
71035887|NCT01592240|141580675|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.9||||0.16|TWO_SIDED|95.0|-1.56|9.36|||Mixed models repeated measures analysis|||Week 24||9.36|-1.56|0.160
70981708|NCT02907944|141471619|SUPERIORITY||Odds Ratio (OR)|1.77||||0.11|TWO_SIDED|95.0|0.88|3.55|||Generalized Estimating Equation|||||3.55|0.88|0.11
70981709|NCT02907944|141471619|SUPERIORITY||Odds Ratio (OR)|1.35||||0.005|TWO_SIDED|95.0|1.09|1.66|||Generalized Estimating Equation|||||1.66|1.09|0.005
70981710|NCT03715465|141471633|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.510
70981711|NCT03715465|141471634|SUPERIORITY|||||||0.411|||||||t-test, 2 sided|||Per diary||||0.411
70981712|NCT03715465|141471634|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||Per wrist actigraphy||||0.920
70981713|NCT03715465|141471635|SUPERIORITY|||||||0.787|||||||t-test, 2 sided|||Per diary||||0.787
70981714|NCT03715465|141471635|SUPERIORITY|||||||0.916|||||||t-test, 2 sided|||Per wrist actigraphy||||0.916
70981715|NCT03715465|141471636|SUPERIORITY|||||||0.27|||||||t-test, 2 sided|||Per diary||||0.270
70981716|NCT03715465|141471636|SUPERIORITY|||||||0.406|||||||t-test, 2 sided|||Per wrist actigraphy||||0.406
70981717|NCT03715465|141471637|SUPERIORITY|||||||0.635|||||||t-test, 2 sided|||Per diary||||0.635
70981718|NCT03715465|141471637|SUPERIORITY|||||||0.383|||||||t-test, 2 sided|||Per wrist actigraphy||||0.383
70981719|NCT03715465|141471638|SUPERIORITY|||||||0.456|||||||t-test, 2 sided|||||||0.456
70981720|NCT03715465|141471639|SUPERIORITY|||||||0.402|||||||t-test, 2 sided|||||||0.402
70981721|NCT03715465|141471640|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||0.047
71035888|NCT01592240|141580675|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.85||||0.758|TWO_SIDED|95.0|-4.56|6.25|||Mixed models repeated measures analysis|||Week 24||6.25|-4.56|0.758
71035889|NCT01592240|141580675|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.57||||0.347|TWO_SIDED|95.0|-2.81|7.95|||Mixed models repeated measures analysis|||Week 24||7.95|-2.81|0.347
71035890|NCT01592240|141580675|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.99||||0.343|TWO_SIDED|95.0|-3.22|9.21|||Mixed models repeated measures analysis|||Week 24||9.21|-3.22|0.343
71035891|NCT01592240|141580675|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.7||||0.824|TWO_SIDED|95.0|-6.87|5.48|||Mixed models repeated measures analysis|||Week 24||5.48|-6.87|0.824
71035892|NCT01592240|141580676|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-18.55|||<|0.001|TWO_SIDED|95.0|-25.44|-11.67|||Mixed models repeated measures analysis|||Week 12||-11.67|-25.44|<0.001
71035893|NCT01592240|141580676|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.67|||<|0.001|TWO_SIDED|95.0|-34.55|-20.79|||Mixed models repeated measures analysis|||Week 12||-20.79|-34.55|<0.001
71035894|NCT01592240|141580676|SUPERIORITY_OR_OTHER||Adjusted mean difference|-32.09|||<|0.001|TWO_SIDED|95.0|-38.95|-25.22|||Mixed models repeated measures analysis|||Week 12||-25.22|-38.95|<0.001
71035895|NCT01592240|141580676|SUPERIORITY_OR_OTHER||Adjusted mean difference|-14.56|||<|0.001|TWO_SIDED|95.0|-22.89|-6.24|||Mixed models repeated measures analysis|||Week 12||-6.24|-22.89|<0.001
71035896|NCT01592240|141580676|SUPERIORITY_OR_OTHER||Adjusted mean difference|-28.5|||<|0.001|TWO_SIDED|95.0|-36.83|-20.16|||Mixed models repeated measures analysis|||Week 12||-20.16|-36.83|<0.001
71035897|NCT01592240|141580676|SUPERIORITY_OR_OTHER||Adjusted mean difference|-19.67|||<|0.001|TWO_SIDED|95.0|-27.07|-12.27|||Mixed models repeated measures analysis|||Week 24||-12.27|-27.07|<0.001
70981722|NCT03715465|141471641|SUPERIORITY|||||||0.525|||||||t-test, 2 sided|||||||0.525
70981723|NCT03715465|141471642|SUPERIORITY|||||||0.106|||||||t-test, 2 sided|||||||0.106
70981724|NCT03715465|141471643|SUPERIORITY|||||||0.059|||||||t-test, 2 sided|||||||0.059
70981725|NCT03715465|141471644|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||0.007
71035898|NCT01592240|141580676|SUPERIORITY_OR_OTHER||Adjusted mean difference|-28.17|||<|0.001|TWO_SIDED|95.0|-35.52|-20.82|||Mixed models repeated measures analysis|||Week 24||-20.82|-35.52|<0.001
70981726|NCT03715465|141471645|SUPERIORITY|||||||0.246|||||||t-test, 2 sided|||||||0.246
70981727|NCT03715465|141471646|SUPERIORITY|||||||0.333|||||||t-test, 2 sided|||||||0.333
70981728|NCT04902885|141471655|SUPERIORITY|||||||0.0003|||||||non-parametric ANCOVA|||70 subjects (35 per group) provided approximately 95% power at the test level of α = 0.05 (2-sided) .Assuming a dropout rate of approximately 12%, the sample size for Part II was 80 subjects (40 per group)||||0.0003
70981729|NCT04331899|141471672|OTHER||Cox Proportional Hazard|0.81||||0.29|TWO_SIDED|95.0|0.56|1.19||Tests were conducted at the 0.05 level of significance.|Regression, Cox||Cox proportional hazards model covariate-adjusted for age 50+ and sex.|||1.19|0.56|0.29
70981730|NCT04331899|141471673|OTHER||Cox Proportional Hazard|-0.06||||0.91|TWO_SIDED|95.0|-1.23|1.11||Tests were conducted at the 0.05 level of significance.|Regression, Linear||Log change at Day 14. Cox proportional hazards model covariate-adjusted for age 50+ and sex.|||1.11|-1.23|0.91
70981731|NCT04331899|141471674|OTHER||Cox Proportional Hazard|1.01||||0.95|TWO_SIDED|95.0|0.85|1.16||Tests were conducted at the 0.05 level of significance.|Regression, Linear||Cox proportional hazards model covariate-adjusted for age 50+ and sex.|||1.16|0.85|0.95
70981732|NCT04331899|141471675|OTHER||Cox Proportional Hazard|0.94||||0.76|TWO_SIDED|95.0|0.6|1.41||Tests were conducted at the 0.05 level of significance.|Regression, Cox||Cox proportional hazards model covariate-adjusted for age 50+ and sex.|||1.41|0.60|0.76
70981733|NCT00101361|141471677|NON_INFERIORITY_OR_EQUIVALENCE|the required sample size of 400 participants provided 85% power to detect an increase in healing from 25% in the placebo group to 40% in the oxandrolone group, as assuming a 0.05 (2-sided) type I error, 13% rate of loss to follow up, and a test of proportions by using an arcsine transformation.|Mean Difference (Final Values)|-5.7|||<|0.05|TWO_SIDED|95.0|-17.5|6.8|||Cochran-Mantel-Haenszel|||For spinal cord injury patients with a Stage III or IV pressure ulcer of the pelvic region who receive 24 weeks or less of optimized clinical care (i.e., guideline-driven care with nutritional support) compared with optimized clinical care and an oral anabolic steroid agent (oxandrolone) there will be no difference in the percent of healed pressure ulcers.||6.8|-17.5|<0.05
70981734|NCT02424539|141471678|OTHER||Mean Difference (Final Values)|-1.23|||<|0.001|TWO_SIDED|95.0|-1.68|-0.78|||ANCOVA||Least square (LS) mean difference between placebo and FF 55 µg QD has been presented using analysis of co-variance (ANCOVA) model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-0.78|-1.68|<0.001
70981735|NCT02424539|141471678|OTHER||Mean Difference (Final Values)|-1.32|||<|0.001|TWO_SIDED|95.0|-1.77|-0.87|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-0.87|-1.77|<0.001
70981736|NCT02424539|141471679|OTHER||Odds Ratio (OR)|0.24|||<|0.001|TWO_SIDED|95.0|0.14|0.39|||Regression, Logistic||Odds ratio for FF 55 µg QD versus placebo has been presented using a logistic regression model with Wald's test with treatment, gender, age and type of Allergic Rhinitis as factors.|||0.39|0.14|<0.001
70981737|NCT02424539|141471679|OTHER||Odds Ratio (OR)|0.2|||<|0.001|TWO_SIDED|95.0|0.12|0.33|||Regression, Logistic||Odds ratio for FF 110 µg QD versus placebo has been presented using a logistic regression model with Wald's test with treatment, gender, age and type of Allergic Rhinitis as factors.|||0.33|0.12|<0.001
71035899|NCT01592240|141580676|SUPERIORITY_OR_OTHER||Adjusted mean difference|-25.41|||<|0.001|TWO_SIDED|95.0|-32.73|-18.09|||Mixed models repeated measures analysis|||Week 24||-18.09|-32.73|<0.001
70981738|NCT02424539|141471680|OTHER||Mean Difference (Final Values)|-2.15|||<|0.001|TWO_SIDED|95.0|-2.84|-1.46|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-1.46|-2.84|<0.001
70981739|NCT02424539|141471680|OTHER||Mean Difference (Final Values)|-1.98|||<|0.001|TWO_SIDED|95.0|-2.66|-1.29|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-1.29|-2.66|<0.001
70981740|NCT02424539|141471681|OTHER||Mean Difference (Final Values)|-0.1||||0.503|TWO_SIDED|95.0|-0.38|0.18|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||0.18|-0.38|0.503
71035900|NCT01592240|141580676|SUPERIORITY_OR_OTHER||Adjusted mean difference|-12.72|||<|0.001|TWO_SIDED|95.0|-19.35|-6.09|||Mixed models repeated measures analysis|||Week 24||-6.09|-19.35|<0.001
70981741|NCT02424539|141471681|OTHER||Mean Difference (Final Values)|-0.25||||0.078|TWO_SIDED|95.0|-0.53|0.03|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||0.03|-0.53|0.078
70981742|NCT02424539|141471682|OTHER||Mean Difference (Final Values)|0.51||||0.048|TWO_SIDED|95.0|0.01|1.02|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||1.02|0.01|0.048
70981743|NCT02424539|141471682|OTHER||Mean Difference (Final Values)|0.66||||0.011|TWO_SIDED|95.0|0.16|1.17|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||1.17|0.16|0.011
70981744|NCT02424539|141471683|OTHER||Mean Difference (Final Values)|-1.36|||<|0.001|TWO_SIDED|95.0|-1.83|-0.9|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-0.90|-1.83|<0.001
70981745|NCT02424539|141471683|OTHER||Mean Difference (Final Values)|-1.46|||<|0.001|TWO_SIDED|95.0|-1.92|-0.99|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-0.99|-1.92|<0.001
70981746|NCT02424539|141471684|OTHER||Odds Ratio (OR)|0.2|||<|0.001|TWO_SIDED|95.0|0.12|0.34|||Regression, Logistic||Odds ratio for FF 55 µg QD versus placebo has been presented using a logistic regression model with Wald's test with treatment, gender, age and type of Allergic Rhinitis as factors.|||0.34|0.12|<0.001
70981747|NCT02424539|141471684|OTHER||Odds Ratio (OR)|0.17|||<|0.001|TWO_SIDED|95.0|0.1|0.29|||Regression, Logistic||Odds ratio for FF 110 µg QD versus placebo has been presented using a logistic regression model with Wald's test with treatment, gender, age and type of Allergic Rhinitis as factors.|||0.29|0.10|<0.001
70981748|NCT02424539|141471685|OTHER||Mean Difference (Final Values)|-2.48|||<|0.001|TWO_SIDED|95.0|-3.23|-1.73|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-1.73|-3.23|<0.001
70981749|NCT02424539|141471685|OTHER||Mean Difference (Final Values)|-2.27|||<|0.001|TWO_SIDED|95.0|-3.03|-1.52|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-1.52|-3.03|<0.001
70981750|NCT02424539|141471686|OTHER||Mean Difference (Final Values)|-0.11||||0.442|TWO_SIDED|95.0|-0.38|0.17|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||0.17|-0.38|0.442
70981751|NCT02424539|141471686|OTHER||Mean Difference (Final Values)|-0.3||||0.035|TWO_SIDED|95.0|-0.57|-0.02|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-0.02|-0.57|0.035
70981752|NCT02424539|141471687|OTHER||Mean Difference (Final Values)|1.88||||0.004|TWO_SIDED|95.0|0.6|3.16|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||3.16|0.60|0.004
70981753|NCT02424539|141471687|OTHER||Mean Difference (Final Values)|2.67|||<|0.001|TWO_SIDED|95.0|1.38|3.95|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||3.95|1.38|<0.001
71035901|NCT01592240|141580676|SUPERIORITY_OR_OTHER||Adjusted mean difference|-16.85|||<|0.001|TWO_SIDED|95.0|-23.47|-10.23|||Mixed models repeated measures analysis|||Week 24||-10.23|-23.47|<0.001
71035902|NCT01592240|141580677|SUPERIORITY_OR_OTHER||Adjusted mean difference|-21.58|||<|0.001|TWO_SIDED|95.0|-29.23|-13.92|||Mixed models repeated measures analysis|||Week 12||-13.92|-29.23|<0.001
71035903|NCT01592240|141580677|SUPERIORITY_OR_OTHER||Adjusted mean difference|-30.54|||<|0.001|TWO_SIDED|95.0|-38.19|-22.89|||Mixed models repeated measures analysis|||Week 12||-22.89|-38.19|<0.001
71035904|NCT01592240|141580677|SUPERIORITY_OR_OTHER||Adjusted mean difference|-35.95|||<|0.001|TWO_SIDED|95.0|-43.59|-28.31|||Mixed models repeated measures analysis|||Week 12||-28.31|-43.59|<0.001
71035905|NCT01592240|141580677|SUPERIORITY_OR_OTHER||Adjusted mean difference|-17.14|||<|0.001|TWO_SIDED|95.0|-25.87|-8.41|||Mixed models repeated measures analysis|||Week 12||-8.41|-25.87|<0.001
71035906|NCT01592240|141580677|SUPERIORITY_OR_OTHER||Adjusted mean difference|-30.72|||<|0.001|TWO_SIDED|95.0|-39.45|-21.98|||Mixed models repeated measures analysis|||Week 12||-21.98|-39.45|<0.001
71035907|NCT01592240|141580677|SUPERIORITY_OR_OTHER||Adjusted mean difference|-22.09|||<|0.001|TWO_SIDED|95.0|-30.32|-13.86|||Mixed models repeated measures analysis|||Week 24||-13.86|-30.32|<0.001
71035908|NCT01592240|141580677|SUPERIORITY_OR_OTHER||Adjusted mean difference|-30.95|||<|0.001|TWO_SIDED|95.0|-39.13|-22.77|||Mixed models repeated measures analysis|||Week 24||-22.77|-39.13|<0.001
71035909|NCT01592240|141580677|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.23|||<|0.001|TWO_SIDED|95.0|-35.38|-19.09|||Mixed models repeated measures analysis|||Week 24||-19.09|-35.38|<0.001
71035910|NCT01592240|141580677|SUPERIORITY_OR_OTHER||Adjusted mean difference|-15.34|||<|0.001|TWO_SIDED|95.0|-22.9|-7.78|||Mixed models repeated measures analysis|||Week 24||-7.78|-22.90|<0.001
71035911|NCT01592240|141580677|SUPERIORITY_OR_OTHER||Adjusted mean difference|-19.15|||<|0.001|TWO_SIDED|95.0|-26.7|-11.59|||Mixed models repeated measures analysis|||Week 24||-11.59|-26.70|<0.001
71035912|NCT01592240|141580678|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.77||||0.667|TWO_SIDED|95.0|-6.33|9.88|||Mixed models repeated measures analysis|||Week 12||9.88|-6.33|0.667
71035913|NCT01592240|141580678|SUPERIORITY_OR_OTHER||Adjusted mean difference|5.44||||0.187|TWO_SIDED|95.0|-2.66|13.54|||Mixed models repeated measures analysis|||Week 12||13.54|-2.66|0.187
71035914|NCT01592240|141580678|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.82||||0.352|TWO_SIDED|95.0|-4.25|11.9|||Mixed models repeated measures analysis|||Week 12||11.90|-4.25|0.352
71035915|NCT01592240|141580678|SUPERIORITY_OR_OTHER||Adjusted mean difference|5.6||||0.09|TWO_SIDED|95.0|-0.89|12.09|||Mixed models repeated measures analysis|||Week 12||12.09|-0.89|0.090
71035916|NCT01592240|141580678|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.36||||0.184|TWO_SIDED|95.0|-2.1|10.82|||Mixed models repeated measures analysis|||Week 12||10.82|-2.10|0.184
71097111|NCT05890586|141703151|SUPERIORITY|No hypothesis test or decision rule was evaluated.|Odds Ratio (OR)|1.45|||||TWO_SIDED|95.0|0.74|2.22|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|Adjustment variables are randomization assignment, age (as restricted cubic spline), sex, duration of symptoms prior to receipt of study drug, calendar time (as restricted cubic spline), vaccination status, geographic region (Northeast, Midwest, South, West), call center indicator, and baseline symptom severity.||2.22|0.74|
71097112|NCT05890586|141703152|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.51|0.83|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||0.83|0.51|
71035917|NCT01592240|141580678|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.59||||0.879|TWO_SIDED|95.0|-7.09|8.28|||Mixed models repeated measures analysis|||Week 24||8.28|-7.09|0.879
71035918|NCT01592240|141580678|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.43||||0.911|TWO_SIDED|95.0|-7.17|8.02|||Mixed models repeated measures analysis|||Week 24||8.02|-7.17|0.911
71035919|NCT01592240|141580678|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.12||||0.283|TWO_SIDED|95.0|-3.44|11.69|||Mixed models repeated measures analysis|||Week 24||11.69|-3.44|0.283
71035920|NCT01592240|141580678|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.41||||0.728|TWO_SIDED|95.0|-9.41|6.59|||Mixed models repeated measures analysis|||Week 24||6.59|-9.41|0.728
71035921|NCT01592240|141580678|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.19||||0.587|TWO_SIDED|95.0|-10.13|5.75|||Mixed models repeated measures analysis|||Week 24||5.75|-10.13|0.587
71035922|NCT01592240|141580679|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.66||||0.89|TWO_SIDED|95.0|-10.05|8.74|||Mixed models repeated measures analysis|||Week 12||8.74|-10.05|0.890
71097113|NCT05890586|141703152|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.7|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.21|0.70|
71097114|NCT05890586|141703152|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.75|||||TWO_SIDED|95.0|0.55|1.03|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.03|0.55|
71097115|NCT05890586|141703152|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.68|1.39|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.39|0.68|
71097116|NCT05890586|141703153|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.29|||||TWO_SIDED|95.0|1.04|1.6|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.60|1.04|
71035923|NCT01592240|141580679|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.32||||0.625|TWO_SIDED|95.0|-7.04|11.68|||Mixed models repeated measures analysis|||Week 12||11.68|-7.04|0.625
71035924|NCT01592240|141580679|SUPERIORITY_OR_OTHER||Adjusted mean difference|6.54||||0.172|TWO_SIDED|95.0|-2.86|15.94|||Mixed models repeated measures analysis|||Week 12||15.94|-2.86|0.172
71035925|NCT01592240|141580679|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.5||||0.109|TWO_SIDED|95.0|-0.79|7.8|||Mixed models repeated measures analysis|||Week 12||7.80|-0.79|0.109
71035926|NCT01592240|141580679|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.67||||0.218|TWO_SIDED|95.0|-1.6|6.94|||Mixed models repeated measures analysis|||Week 12||6.94|-1.60|0.218
71035927|NCT01592240|141580679|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.86||||0.812|TWO_SIDED|95.0|-8.01|6.29|||Mixed models repeated measures analysis|||Week 24||6.29|-8.01|0.812
71035928|NCT01592240|141580679|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.15||||0.749|TWO_SIDED|95.0|-8.24|5.94|||Mixed models repeated measures analysis|||Week 24||5.94|-8.24|0.749
71035929|NCT01592240|141580679|SUPERIORITY_OR_OTHER||Adjusted mean difference|5.82||||0.108|TWO_SIDED|95.0|-1.29|12.93|||Mixed models repeated measures analysis|||Week 24||12.93|-1.29|0.108
71035930|NCT01592240|141580679|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.83||||0.752|TWO_SIDED|95.0|-5.99|4.34|||Mixed models repeated measures analysis|||Week 24||4.34|-5.99|0.752
71035931|NCT01592240|141580679|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.55||||0.55|TWO_SIDED|95.0|-6.68|3.57|||Mixed models repeated measures analysis|||Week 24||3.57|-6.68|0.550
71035932|NCT01592240|141580680|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.19||||0.893|TWO_SIDED|95.0|-2.62|3.0|||Mixed models repeated measures analysis|||Week 12||3.00|-2.62|0.893
71097117|NCT05890586|141703153|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.98|1.51|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.51|0.98|
71035933|NCT01592240|141580680|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.33||||0.355|TWO_SIDED|95.0|-1.49|4.15|||Mixed models repeated measures analysis|||Week 12||4.15|-1.49|0.355
71035934|NCT01592240|141580680|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.64||||0.655|TWO_SIDED|95.0|-3.45|2.17|||Mixed models repeated measures analysis|||Week 12||2.17|-3.45|0.655
71035935|NCT01592240|141580680|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.49||||0.719|TWO_SIDED|95.0|-3.2|2.21|||Mixed models repeated measures analysis|||Week 12||2.21|-3.20|0.719
70981754|NCT00728416|141471776|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.31|||<|0.001|TWO_SIDED|95.0|-0.43|-0.19|||ANCOVA|||The change from Baseline in average AM/PM PRIOR nasal congestion score over 15 days: MFNS 200 mcg daily vs placebo. The difference in LS means (MFNS - Placebo) was calculated from an ANCOVA model with treatment, site and baseline AM/PM PRIOR Nasal Congestion Score as covariates.||-0.19|-0.43|<0.001
70981755|NCT00728416|141471777|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.27|||<|0.001|TWO_SIDED|95.0|-1.72|-0.83|||ANCOVA|||The change from Baseline in average AM/PM PRIOR TNSS over 15 days: MFNS 200 mcg daily vs placebo. The difference in LS means (MFNS - Placebo) was calculated from an ANCOVA model with treatment, site and baseline AM/PM TNSS as covariates.||-0.83|-1.72|<0.001
70981756|NCT01244737|141471785|OTHER||Pearson correlation co-efficient|0.8|||<|0.001|TWO_SIDED|||||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|||This is a diagnostic test of FLT uptake (SUV max) as a predictor of cellular proliferation (MIB) and is performed as an analysis of correlation using each evaluable participant enrolled in either Arm 1 (New Diagnosis) or Arm 2 (Possible recurrent tumor). The groups (Arm 1 and Arm 2) provide pathways for enrollment. Correlation between the two measures of outcome (SUV max and MIB) is evaluated.||||< 0.001
70981757|NCT01244737|141471788|OTHER|Paired T-test to assess change in FLT uptake (SUV max) with chemotherapy.||||||0.04||||||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||||||0.04
70981758|NCT02039947|141471807|SUPERIORITY||Response rate|59.0|||<|0.0001|TWO_SIDED|95.0|47.3|70.4|||percent||Percent|||70.4|47.3|<.0001
70981759|NCT01772134|141471815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.147|||<|0.001|TWO_SIDED|95.0|0.107|0.187|||Mixed Models Analysis|||||0.187|0.107|<0.001
70981760|NCT01772134|141471815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.138|||<|0.001|TWO_SIDED|95.0|0.097|0.178|||Mixed Models Analysis|||||0.178|0.097|<0.001
71097118|NCT05890586|141703153|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.84|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.35|0.84|
70981761|NCT01740362|141471819|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|137.26|||||TWO_SIDED|90.0|96.77|194.69||||||1 way Analysis of Variance (ANOVA) on natural log-transformed AUC(0-∞) analyzed using linear model with degrees of renal impairment(creatinine clearance\[CLcr, discrete\]) evaluated using blood samples collected at screening as fixed effect. Statistical Analysis System (SAS) mixed procedure (PROC MIXED) was used. Anti-log of adjusted mean difference (CP-690,550\[mild renal insufficiency\] - CP-690,550\[normal renal function\]), 90% confidence interval (CI) were taken to estimate mean ratio and 90% CI.||194.69|96.77|
70981762|NCT01740362|141471819|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|142.59|||||TWO_SIDED|90.0|100.53|202.24||||||One way ANOVA on natural log-transformed AUC (0 - ∞) were analyzed using linear model containing degrees of renal impairment (CLcr, discrete) calculated using blood samples collected at screening as fixed effects. SAS procedure PROC MIXED was used for analysis. Anti-log of the adjusted mean difference (CP-690,550 \[moderate renal insufficiency\] - CP-690,550 \[normal renal function\]) and its corresponding 90% CI were taken to estimate the mean ratio and corresponding 90% CI.||202.24|100.53|
70981763|NCT01740362|141471819|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|222.71|||||TWO_SIDED|90.0|157.02|315.89||||||One way ANOVA on natural log-transformed AUC (0 - ∞) were analyzed using linear model containing degrees of renal impairment (CLcr, discrete) calculated using blood samples collected at screening as fixed effects. SAS procedure PROC MIXED was used for analysis. Anti-log of the adjusted mean difference (CP-690,550 \[severe renal insufficiency\] - CP-690,550 \[normal renal function\]) and its corresponding 90% CI were taken to estimate the mean ratio and corresponding 90% CI.||315.89|157.02|
70981764|NCT01740362|141471820|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|93.15|||||TWO_SIDED|90.0|67.22|129.06||||||One way ANOVA on natural log-transformed Cmax were analyzed using linear model containing degrees of renal impairment (CLcr, discrete) calculated using blood samples collected at screening as fixed effects. SAS procedure PROC MIXED was used for analysis. Anti-log of the adjusted mean difference (CP-690,550 \[mild renal insufficiency\] - CP-690,550 \[normal renal function\]) and its corresponding 90% CI were taken to estimate the mean ratio and corresponding 90% CI.||129.06|67.22|
70981765|NCT01740362|141471820|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|104.17|||||TWO_SIDED|90.0|75.18|144.34||||||One way ANOVA on natural log-transformed Cmax were analyzed using linear model containing degrees of renal impairment (CLcr, discrete) calculated using blood samples collected at screening as fixed effects. SAS procedure PROC MIXED was used for analysis. Anti-log of the adjusted mean difference (CP-690,550 \[moderate renal insufficiency\] - CP-690,550 \[normal renal function\]) and its corresponding 90% CI were taken to estimate the mean ratio and corresponding 90% CI.||144.34|75.18|
71035936|NCT01592240|141580680|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.41||||0.768|TWO_SIDED|95.0|-2.31|3.12|||Mixed models repeated measures analysis|||Week 12||3.12|-2.31|0.768
71035937|NCT01592240|141580680|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.66||||0.199|TWO_SIDED|95.0|-0.88|4.2|||Mixed models repeated measures analysis|||Week 24||4.20|-0.88|0.199
71097119|NCT05890586|141703153|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.92|1.47|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.47|0.92|
71035938|NCT01592240|141580680|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.9||||0.483|TWO_SIDED|95.0|-1.62|3.41|||Mixed models repeated measures analysis|||Week 24||3.41|-1.62|0.483
71035939|NCT01592240|141580680|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.03||||0.42|TWO_SIDED|95.0|-1.49|3.56|||Mixed models repeated measures analysis|||Week 24||3.56|-1.49|0.420
71035940|NCT01592240|141580680|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.69||||0.488|TWO_SIDED|95.0|-2.67|1.28|||Mixed models repeated measures analysis|||Week 24||1.28|-2.67|0.488
71035941|NCT01592240|141580680|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.39||||0.694|TWO_SIDED|95.0|-2.36|1.58|||Mixed models repeated measures analysis|||Week 24||1.58|-2.36|0.694
70981766|NCT01740362|141471820|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|117.65|||||TWO_SIDED|95.0|84.91|163.02||||||One way ANOVA on natural log-transformed Cmax were analyzed using linear model containing degrees of renal impairment (CLcr, discrete) calculated using blood samples collected at screening as fixed effects. SAS procedure PROC MIXED was used for analysis. Anti-log of the adjusted mean difference (CP-690,550 \[severe renal insufficiency\] - CP-690,550 \[normal renal function\]) and its corresponding 90% CI were taken to estimate the mean ratio and corresponding 90% CI.||163.02|84.91|
70981767|NCT00594399|141471826|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||Omnibus test of difference between groups over time with Bonferroni correction and adjustment for baseline value of insulin|Mixed Models Analysis|||||||0.43
71097120|NCT05890586|141703154|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.8|1.29|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.29|0.80|
71097121|NCT05890586|141703154|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.84|1.47|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.47|0.84|
71097122|NCT05890586|141703154|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.8|1.46|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.46|0.80|
70981768|NCT00594399|141471829|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED|||||Omnibus test of difference between groups over time with Bonferroni correction and adjustment for baseline value of glucose|Mixed Models Analysis|||||||0.91
70981769|NCT00594399|141471832|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Omnibus test of difference between groups over time with adjustment for baseline value of physical activity|Mixed Models Analysis|||||||<0.001
70981770|NCT02698189|141471954|OTHER|80% Bayesian credible interval based on a prior distribution of Beta (1, 1).|||||||||||||||||80% 2-sided Bayesian credible interval: lower = 0.000; upper = 0.415|||
70981771|NCT02698189|141471954|OTHER|80% Bayesian credible interval based on a prior distribution of Beta (1, 1).|||||||||||||||||80% 2-sided Bayesian credible interval: lower = 0.040; upper = 0.391|||
70981772|NCT03232073|141472040|SUPERIORITY||Treatment Effect (Rate Ratio)|0.779||||||95.0|0.629|0.965||||||||0.965|0.629|
70981773|NCT03528681|141472083|OTHER||Back-transformed mean difference|0.93|||<|0.001|TWO_SIDED|95.0|0.902|0.959|||Mixed Models Analysis|||Results are derived from a longitudinal model applied to log-transformed S-K measurements adjusted for treatment, visit, treatment-by-visit interaction and baseline covariates. The back-transformation is to the original scale of the S-K measurement||0.959|0.902|<0.001
70981774|NCT03528681|141472083|OTHER||Back-transformed mean difference|0.85|||<|0.001|TWO_SIDED|95.0|0.825|0.876|||Mixed Models Analysis|||Results are derived from a longitudinal model applied to log-transformed S-K measurements adjusted for treatment, visit, treatment-by-visit interaction and baseline covariates. The back-transformation is to the original scale of the S-K measurement||0.876|0.825|<0.001
70981775|NCT03528681|141472088|OTHER|The analysis uses a generalized mixed model which includes a random intercept and logit link. The model includes all S-K data values collected at the scheduled visits between Days 8-29, dichotomized as normal and abnormal, as response variables, and baseline covariates. Placebo is the reference group.|Odds Ratio (OR)|3.8|||<|0.001|TWO_SIDED|95.0|2.17|6.67|||Mixed Models Analysis|||||6.67|2.17|<0.001
70981776|NCT03528681|141472088|OTHER||Odds Ratio (OR)|11.63|||<|0.001|TWO_SIDED|95.0|6.45|21.0|||Mixed Models Analysis|||The analysis uses a generalized mixed model which includes a random intercept and logit link. The model includes all S-K data values collected at the scheduled visits between Days 8-29, dichotomized as normal and abnormal, as response variables, and baseline covariates. Placebo is the reference group.||21.00|6.45|<0.001
71035942|NCT01592240|141580681|SUPERIORITY_OR_OTHER||Adjusted mean difference|10.29||||0.527|TWO_SIDED|95.0|-21.73|42.3|||Mixed models repeated measures analysis|||Week 12||42.30|-21.73|0.527
70981777|NCT03528681|141472089|OTHER|The model included normokalaemia status (yes, no) on Day 29 as binary response variables, and baseline covariates. Placebo is the reference group.|Odds Ratio (OR)|2.54||||0.035|TWO_SIDED|95.0|1.07|6.05|||Regression, Logistic|||||6.05|1.07|0.035
71035943|NCT01592240|141580681|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.39||||0.981|TWO_SIDED|95.0|-31.49|32.26|||Mixed models repeated measures analysis|||Week 12||32.26|-31.49|0.981
71035944|NCT01592240|141580681|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.54||||0.974|TWO_SIDED|95.0|-31.72|32.8|||Mixed models repeated measures analysis|||Week 12||32.80|-31.72|0.974
71035945|NCT01592240|141580681|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.58||||0.64|TWO_SIDED|95.0|-8.25|5.09|||Mixed models repeated measures analysis|||Week 12||5.09|-8.25|0.640
70981778|NCT03528681|141472089|OTHER||Odds Ratio (OR)|6.25|||<|0.001|TWO_SIDED|95.0|2.56|15.27|||Regression, Logistic|||The model included normokalaemia status (yes, no) on Day 29 as binary response variables, and baseline covariates. Placebo is the reference group.||15.27|2.56|<0.001
70981779|NCT03528681|141472090|OTHER||Median Difference (Final Values)|5.72|||<|0.001|TWO_SIDED|95.0|3.13|8.31|||Regression, Linear|||Results derived from a linear regression model with the following covariates: treatment group; baseline S-K values (Open-label phase and Randomized treatment phase); baseline eGFR; age category; country; baseline RAAS inhibitor, chronic kidney disease, heart failure, and diabetes mellitus statuses.||8.31|3.13|<0.001
70981780|NCT03528681|141472090|OTHER||Mean Difference (Final Values)|11.14|||<|0.001|TWO_SIDED|95.0|8.57|13.71|||Regression, Linear|||Results derived from a linear regression model with the following covariates: treatment group; baseline S-K values (Open-label phase and Randomized treatment phase); baseline eGFR; age category; country; baseline RAAS inhibitor, chronic kidney disease, heart failure, and diabetes mellitus statuses.||13.71|8.57|<0.001
71035946|NCT01592240|141580681|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.08||||0.75|TWO_SIDED|95.0|-5.61|7.77|||Mixed models repeated measures analysis|||Week 12||7.77|-5.61|0.750
71035947|NCT01592240|141580681|SUPERIORITY_OR_OTHER||Adjusted mean difference|9.8||||0.509|TWO_SIDED|95.0|-19.41|39.01|||Mixed models repeated measures analysis|||Week 24||39.01|-19.41|0.509
70981781|NCT03528681|141472093|OTHER||Mean Difference (Final Values)|-105.248|||<|0.001|TWO_SIDED|95.0|-161.293|-49.203|||Mixed Models Analysis|||S-Aldo Results derived from a longitudinal mixed model adjusted for treatment, visit, treatment-by-visit interaction and baseline covariates||-49.203|-161.293|<0.001
70981782|NCT03528681|141472093|OTHER||Median Difference (Final Values)|-137.267|||<|0.001|TWO_SIDED|95.0|-192.596|-81.937|||Mixed Models Analysis|||S-Aldo Results derived from a longitudinal mixed model adjusted for treatment, visit, treatment-by-visit interaction and baseline covariates||-81.937|-192.596|<0.001
70981783|NCT03528681|141472093|OTHER||Mean Difference (Final Values)|0.014||||0.839|TWO_SIDED|95.0|-0.12|0.147|||Mixed Models Analysis|||P-Renin Results derived from a longitudinal mixed model adjusted for treatment, visit, treatment-by-visit interaction and baseline covariates||0.147|-0.120|0.839
70981784|NCT03528681|141472093|OTHER||Mean Difference (Final Values)|-0.062||||0.355|TWO_SIDED|95.0|-0.195|0.07|||Mixed Models Analysis|||P-Renin Results derived from a longitudinal mixed model adjusted for treatment, visit, treatment-by-visit interaction and baseline covariates||0.070|-0.195|0.355
70981785|NCT03528681|141472095|OTHER||Hazard Ratio (HR)|0.39|||<|0.001|TWO_SIDED|95.0|0.27|0.57|||Regression, Cox|||The model included time to reoccurrence of hyperkalaemia as response variable (event: hyperkalaemia or discontinue treatment in RTP due to high S-K levels), baseline eGFR, OLP and RTP baseline S-K values as well as age (\< 55, 55-64, \> 64 years) and baseline binary indicators for RAASi, chronic kidney disease, heart failure, and diabetes mellitus as covariates. Placebo is the reference group||0.57|0.27|<0.001
70981786|NCT03528681|141472095|OTHER||Hazard Ratio (HR)|0.16|||<|0.001|TWO_SIDED|95.0|0.1|0.25|||Regression, Cox|||The model included time to reoccurrence of hyperkalaemia as response variable (event: hyperkalaemia or discontinue treatment in RTP due to high S-K levels), baseline eGFR, OLP and RTP baseline S-K values as well as age (\< 55, 55-64, \> 64 years) and baseline binary indicators for RAASi, chronic kidney disease, heart failure, and diabetes mellitus as covariates. Placebo is the reference group||0.25|0.10|<0.001
70981787|NCT00955110|141472096|SUPERIORITY_OR_OTHER||Least Square Means Difference|-28.8|||<|0.001|TWO_SIDED|95.0|-41.6|-16.0||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA|||||-16.0|-41.6|<0.001
71035948|NCT01592240|141580681|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.69||||0.855|TWO_SIDED|95.0|-31.76|26.38|||Mixed models repeated measures analysis|||Week 24||26.38|-31.76|0.855
71035949|NCT01592240|141580681|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.04||||0.839|TWO_SIDED|95.0|-26.39|32.47|||Mixed models repeated measures analysis|||Week 24||32.47|-26.39|0.839
70981788|NCT00955110|141472096|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-50.5|||<|0.001|TWO_SIDED|95.0|-63.4|-37.5||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA|||||-37.5|-63.4|<0.001
70981789|NCT00955110|141472096|SUPERIORITY_OR_OTHER||Least Square Mean Difference|5.5||||0.395|TWO_SIDED|95.0|-7.3|18.3||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA|||||18.3|-7.3|0.395
70981790|NCT00955110|141472096|SUPERIORITY_OR_OTHER||Least Square Mean Difference|38.0|||<|0.001|TWO_SIDED|95.0|25.2|50.8||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA|||||50.8|25.2|<0.001
70981791|NCT00955110|141472096|SUPERIORITY_OR_OTHER||Least Square Mean Difference|56.0|||<|0.001|TWO_SIDED|95.0|43.1|68.9||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA|||||68.9|43.1|<0.001
70981792|NCT00955110|141472096|SUPERIORITY_OR_OTHER||Least Square Mean Difference|66.8|||<|0.001|TWO_SIDED|95.0|53.9|79.7||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA|||||79.7|53.9|<0.001
71035950|NCT01592240|141580681|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.99||||0.392|TWO_SIDED|95.0|-6.57|2.59|||Mixed models repeated measures analysis|||Week 24||2.59|-6.57|0.392
71035951|NCT01592240|141580681|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.33||||0.565|TWO_SIDED|95.0|-5.91|3.24|||Mixed models repeated measures analysis|||Week 24||3.24|-5.91|0.565
71035952|NCT01592240|141580695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.964|||<|0.001|TWO_SIDED|95.0|3.997|56.02|||Regression, Logistic|||Week 12, Less than 100 mg/dL||56.020|3.997|<0.001
71035953|NCT01592240|141580695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|49.615|||<|0.001|TWO_SIDED|95.0|7.984|308.328|||Regression, Logistic|||Week 12, Less than 100 mg/dL||308.328|7.984|<0.001
71035954|NCT01592240|141580695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.842|||<|0.001|TWO_SIDED|95.0|3.674|44.892|||Regression, Logistic|||Week 12, Less than 100 mg/dL||44.892|3.674|<0.001
71035955|NCT01592240|141580695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.107||||0.01|TWO_SIDED|95.0|1.304|7.401|||Regression, Logistic|||Week 12, Less than 100 mg/dL||7.401|1.304|0.010
71035956|NCT01592240|141580695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.048|||<|0.001|TWO_SIDED|95.0|2.402|15.225|||Regression, Logistic|||Week 12, Less than 100 mg/dL||15.225|2.402|<0.001
70981793|NCT04893265|141472124|SUPERIORITY||Mean Difference (Net)|0.0854|STANDARD_ERROR_OF_MEAN|0.1122||0.4471|TWO_SIDED|95.0|-0.1352|0.306|||Mixed Models Analysis|||||0.3060|-0.1352|0.4471
71035957|NCT01592240|141580695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.773|||<|0.001|TWO_SIDED|95.0|3.932|41.495|||Regression, Logistic|||Week 24, Less than 100 mg/dL||41.495|3.932|<0.001
71035958|NCT01592240|141580695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|36.886|||<|0.001|TWO_SIDED|95.0|8.33|163.335|||Regression, Logistic|||Week 24, Less than 100 mg/dL||163.335|8.330|<0.001
70981794|NCT04893265|141472125|SUPERIORITY||Odds Ratio (OR)|0.8378|||<|0.05|TWO_SIDED|95.0|0.4284|1.6385|||Mixed Models Analysis|Adjusted for Demographics, COVID-19 Cases Per 100K , Test Access, Social Network, Knowledge, Test Value with random intercepts for participation mode|Adjusted odds ratio|||1.6385|0.4284|<0.05
70981795|NCT04893265|141472126|SUPERIORITY||Odds Ratio (OR)|1.4306|||<|0.05|TWO_SIDED|95.0|0.6166|3.3192|||Mixed Models Analysis|Adjusted for Demographics, COVID-19 Cases Per 100K , Test Access, Social Network, Knowledge, Test Value with random intercepts for participation mode|Adjusted odds ratio|||3.3192|0.6166|<0.05
70981796|NCT04893265|141472127|SUPERIORITY||Mean Difference (Final Values)|0.08661|STANDARD_ERROR_OF_MEAN|0.08125|||TWO_SIDED|95.0|-0.07311|0.2463|||||Adjusted for Demographics, COVID Cases Per 100,000 Population, Test Access, Social Network, Knowledge, and Test Value with random intercepts for Dyad and Individual|||0.2463|-0.07311|
70981797|NCT03818815|141472139|SUPERIORITY|||||||0.62||||||The p-value was calculated using multiple imputation with number of imputations equal to percentage of missing data.|Regression, Logistic|||The summary statistics are based on subjects with non-missing data only.||||0.62
70981798|NCT03818815|141472140|SUPERIORITY|||||||0.07||||||The p-value was calculated using multiple imputation with number of imputations equal to percentage of missing data.|Regression, Logistic|||The summary statistics are based on subjects with non-missing data only.||||0.07
70981799|NCT02158533|141472155|SUPERIORITY||Least squares mean difference|-1.8|STANDARD_ERROR_OF_MEAN|1.14||0.109|TWO_SIDED|95.0|-4.1|0.4||Hypothesis tests were two-sided with an alpha of 0.05. Control of type 1 error inflation due to multiplicity was achieved by pre-specifying a fixed sequence for statistical tests.|Mixed Models Analysis|ALKS 5461 was compared to pbo using stage-specific MMRM for MADRS-10 Change from Baseline. Model-derived estimates were combined using equal weights.|Estimates below zero favor ALKS 5461.|Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 2mg/2mg was compared to placebo (i.e., ALKS 5461 2mg/2mg S1 vs Placebo S1; and ALKS 5461 2mg/2mg S2 vs Placebo S2. The pre-specified order of hypothesis tests was ALKS 5461 2/2 compared to placebo followed by ALKS 5461 0.5mg/0.5mg compared to placebo.||0.4|-4.1|0.109
70981800|NCT02158533|141472155|SUPERIORITY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|1.17||0.975|TWO_SIDED|95.0|-2.3|2.3||Hypothesis tests were two-sided with an alpha of 0.05. Control of type 1 error inflation due to multiplicity was achieved by pre-specifying a fixed sequence for statistical tests.|Mixed Models Analysis|ALKS 5461 was compared to pbo using stage-specific MMRM for MADRS-10 Change from Baseline. Model-derived estimates were combined using equal weights.|Estimates below zero favor ALKS 5461.|Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 0.5mg/0.5mg was compared to placebo (i.e., ALKS 5461 0.5mg/0.5mg S1 vs Placebo S1; and ALKS 5461 0.5mg/0.5mg S2 vs Placebo S2). The pre-specified order of hypothesis tests was ALKS 5461 2/2 compared to placebo followed by ALKS 5461 0.5/0.5 compared to placebo.||2.3|-2.3|0.975
70981801|NCT01475955|141472164|SUPERIORITY_OR_OTHER|||||||0.0041||95.0|||||Chi-squared|||Pearson chi-square||||0.0041
70981802|NCT00756002|141472243|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|Least Squares (LS) means from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||One subject did not have postsleep questionnaire data on day 2; however, had polysomnography data recorded. Analysis was based on LOCF data.||||<0.001
70981803|NCT00756002|141472244|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
71035959|NCT01592240|141580695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.75|||<|0.001|TWO_SIDED|95.0|5.741|75.006|||Regression, Logistic|||Week 24, Less than 100 mg/dL||75.006|5.741|<0.001
70981804|NCT00756002|141472245|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
70981805|NCT00756002|141472246|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||One subject did not have postsleep questionnaire data on day 2; however, had polysomnography data recorded. Analysis was based on LOCF data.||||0.003
70981806|NCT00756002|141472247|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
70981807|NCT00756002|141472248|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
70981808|NCT00756002|141472249|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
71035960|NCT01592240|141580695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.219||||0.001|TWO_SIDED|95.0|2.061|18.764|||Regression, Logistic|||Week 24, Less than 100 mg/dL||18.764|2.061|0.001
71035961|NCT01592240|141580695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.205||||0.001|TWO_SIDED|95.0|2.06|18.693|||Regression, Logistic|||Week 24, Less than 100 mg/dL||18.693|2.060|0.001
71035962|NCT01592240|141580695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|27.703|||<|0.001|TWO_SIDED|95.0|5.752|133.423|||Regression, Logistic|||Week 12, Less than 70 mg/dL||133.423|5.752|<0.001
71035963|NCT01592240|141580695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|71.177|||<|0.001|TWO_SIDED|95.0|13.783|367.564|||Regression, Logistic|||Week 12, Less than 70 mg/dL||367.564|13.783|<0.001
71035964|NCT01592240|141580695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|100.667|||<|0.001|TWO_SIDED|95.0|19.855|510.387|||Regression, Logistic|||Week 12, Less than 70 mg/dL||510.387|19.855|<0.001
70981809|NCT00756002|141472250|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
70981810|NCT00756002|141472251|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
70981811|NCT00756002|141472252|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
70981812|NCT00756002|141472253|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
70981813|NCT00756002|141472254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
70981814|NCT00756002|141472255|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||LS means from ANCOVA model with effects for treatment \& pooled center, with Baseline as a covariate. P-values from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|||||||<0.001
70981815|NCT00756002|141472256|SUPERIORITY_OR_OTHER|||||||0.043||95.0||||LS means from ANCOVA model with effects for treatment \& pooled center, with Baseline as a covariate. P-values from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|||||||0.043
70981816|NCT00756002|141472257|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.005
70981817|NCT00756002|141472258|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.010
70981818|NCT00756002|141472259|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.002
70981819|NCT00756002|141472260|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.006
70981820|NCT00756002|141472261|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with the Baseline value as a covariate.||||||<0.001
70981821|NCT00756002|141472262|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with the Baseline value as a covariate.||||||<0.001
71035965|NCT01592240|141580695|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 70 mg/dL.||||<0.001
70981822|NCT00756002|141472263|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with the Baseline value as a covariate.||||||<0.001
70981823|NCT00756002|141472264|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
70981824|NCT00756002|141472265|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
70981825|NCT00756002|141472266|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
71035966|NCT01592240|141580695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.941|||<|0.001|TWO_SIDED|95.0|6.336|98.169|||Regression, Logistic|||Week 24, Less than 70 mg/dL.||98.169|6.336|<0.001
71035967|NCT01592240|141580695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|80.004|||<|0.001|TWO_SIDED|95.0|18.094|353.742|||Regression, Logistic|||Week 24, Less than 70 mg/dL.||353.742|18.094|<0.001
70981826|NCT00756002|141472267|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
70981827|NCT00756002|141472268|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
70981828|NCT00756002|141472269|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
70981829|NCT00756002|141472270|SUPERIORITY_OR_OTHER|||||||0.785||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.785
70981830|NCT00756002|141472271|SUPERIORITY_OR_OTHER|||||||0.422||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.422
71035968|NCT01592240|141580695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|42.101|||<|0.001|TWO_SIDED|95.0|10.621|166.894|||Regression, Logistic|||Week 24, Less than 70 mg/dL.||166.894|10.621|<0.001
71035969|NCT01592240|141580695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.7||||0.023|TWO_SIDED|95.0|1.396|98.075|||Regression, Logistic|||Week 24, Less than 70 mg/dL.||98.075|1.396|0.023
71035970|NCT01592240|141580695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|36.841|||<|0.001|TWO_SIDED|95.0|4.527|299.817|||Regression, Logistic|||Week 24, Less than 70 mg/dL||299.817|4.527|<0.001
71097123|NCT05890586|141703154|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.77|1.44|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.44|0.77|
71097124|NCT05890586|141703155|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.7|1.16|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.16|0.70|
70981831|NCT00756002|141472272|SUPERIORITY_OR_OTHER|||||||0.665||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.665
70981832|NCT00756002|141472273|SUPERIORITY_OR_OTHER|||||||0.228||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.228
70981833|NCT00756002|141472274|SUPERIORITY_OR_OTHER|||||||0.099||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.099
70981834|NCT00756002|141472275|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.005
70981835|NCT00756002|141472276|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.004
70981836|NCT00756002|141472277|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.001
71035971|NCT01592240|141580695|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 40 mg/dL.||||<0.001
71035972|NCT01592240|141580695|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 40 mg/dL.||||<0.001
71035973|NCT01592240|141580695|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 40 mg/dL.||||<0.001
71035974|NCT01592240|141580695|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 24, Less than 40 mg/dL.||||<0.001
71035975|NCT01592240|141580695|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 24, Less than 40 mg/dL.||||<0.001
71035976|NCT01592240|141580695|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 24, Less than 40 mg/dL.||||<0.001
70981837|NCT00756002|141472278|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.004
70981838|NCT00756002|141472279|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.040
71035977|NCT01592240|141580695|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 25 mg/dL.||||<0.001
71035978|NCT01592240|141580695|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 25 mg/dL.||||<0.001
70981839|NCT00756002|141472280|SUPERIORITY_OR_OTHER|||||||0.814||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.814
71035979|NCT01592240|141580695|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 25 mg/dL.||||<0.001
71035980|NCT01592240|141580695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.587||||1|||||||Regression, Logistic|||Week 24, Less than 25 mg/dL||||1.000
71035981|NCT01592240|141580695|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 24, Less than 25 mg/dL.||||<0.001
71035982|NCT01592240|141580695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.925||||1|||||||Regression, Logistic|||Week 24, Less than 25 mg/dL||||1.000
71035983|NCT01011413|141580708|NON_INFERIORITY|"Only the primary endpoint is assessed in terms of non-inferiority. All other comparisons are tests for superiority and are considered statistically significant at a two-sided alpha=0.05.~Non-inferiority of EFV 400 mg was defined as the lower 95% confidence interval (CI) of the difference between groups in the proportion of viral load below 200 copies/mL at week 48 lying above -10%."||||||0.05||||||No adjustments were made for multiple comparisons|Pearson's chi-squared|Pearson's chi-squared or Fisher's exact test derived p value was used||Sample size calculation assumes 85% of participants randomised to 600mg EFV arm will have plasma HIV RNA \<200 copies/ml at 48 weeks. Assuming no difference between randomised treatments in proportion with plasma HIV RNA \<200 copies/mL, to have 90% power to demonstrate non-inferiority in the intention to treat (ITT) analysis using a 10% non-inferiority margin will require 286 participants per arm, making a total of 572 participants. Power for modified ITT analysis was 93%.||||0.05
71035984|NCT01011413|141580708|NON_INFERIORITY|Non-inferiority will be defined as the lower 95% confidence limit of the difference in percentages of patients with undetectable viral load lying above -10% (i.e. a non-inferiority margin of 10%).||||||0.05||||||No adjustment for multiple comparisons|Chi-squared|||To ensure the per protocol (PP) analysis has 90% power to demonstrate non-inferiority, the sample size was inflated for patients who switch treatment for toxicity. This is estimated to be no more than 10% randomised patients. To ensure 90% power to demonstrate non-inferiority in the ITT and PP analyses, a total of 630 (315 per arm) patients will be randomised giving 93% power for the ITT analysis. Null hypothesis: no statistically significant difference between the 600mg and 400mg EFV regimens.||||0.05
71035985|NCT01011413|141580709|SUPERIORITY_OR_OTHER_LEGACY||difference between proportions|0.05||||0.05|TWO_SIDED|95.0||||P-value not adjusted for multiple comparisons|Chi-squared|||||||0.05
71035986|NCT03246503|141580718|OTHER||Pearson correlation coefficient|0.82|||<|0.001|TWO_SIDED|95.0|0.77|0.87||statistical significance of Pearson correlation coefficient|Pearson correlation coefficient||Bootstrapping with 1000 replications was used to estimate 95% confidence intervals.|Bootstrapping with 1000 replications was used to estimate 95% confidence intervals.||.87|0.77|<.001
71035987|NCT03246503|141580719|OTHER|t-statistic from regression analysis|intercept of regression line|4.13|||<|0.001|TWO_SIDED|95.0|3.35|4.91|||Regression, Linear|||||4.91|3.35|<.001
71035988|NCT03246503|141580720|OTHER|t-statistic from regression analysis|Slope|0.68|||<|0.001|TWO_SIDED|95.0|0.6|0.76|||Regression, Linear|||||0.76|0.60|<.001
71035989|NCT03206749|141580761|SUPERIORITY||Least Squares (LS) Mean Difference|29.5|||<|0.0001|TWO_SIDED|95.0|16.61|42.4|||ANCOVA|||||42.40|16.61|<0.0001
71035990|NCT03206749|141580762|SUPERIORITY||LS Mean Difference|28.53|||<|0.0001|TWO_SIDED|95.0|16.18|40.88|||ANCOVA|||||40.88|16.18|<0.0001
71035991|NCT03206749|141580763|SUPERIORITY||LS Mean Difference|62.79|||<|0.0001|TWO_SIDED|95.0|36.3|89.27|||ANCOVA|||||89.27|36.30|<0.0001
71035992|NCT03206749|141580764|SUPERIORITY||Hazard Ratio (HR)|1.47||||0.0469|TWO_SIDED|95.0|1.01|2.16|||Regression, Cox|||||2.16|1.01|0.0469
71035993|NCT03206749|141580765|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.3294|TWO_SIDED|95.0|0.79|2.0|||Regression, Cox|||||2.00|0.79|0.3294
71035994|NCT03206749|141580766|SUPERIORITY|||||||0.2341|||||||Regression, Cox|||||||0.2341
71035995|NCT03206749|141580767|SUPERIORITY|||||||0.3358||||||0 - 24 hours|Cochran-Mantel-Haenszel|||||||0.3358
71035996|NCT03206749|141580767|SUPERIORITY|||||||0.0849||||||Greater than (\>) 24 - 48 hours|Cochran-Mantel-Haenszel|||||||0.0849
71035997|NCT03206749|141580768|SUPERIORITY|||||||0.0004||||||0 - 24 hours|Wilcoxon rank-sum test|||||||0.0004
71035998|NCT03206749|141580768|SUPERIORITY|||||||0.0035||||||\>24 - 48 hours|Wilcoxon rank-sum test|||||||0.0035
70981840|NCT00756002|141472281|SUPERIORITY_OR_OTHER|||||||0.929||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.929
71035999|NCT01492439|141580785|SUPERIORITY_OR_OTHER|||||||0.029||||||This applies to Semester 1.|t-test, 1 sided|||||||0.029
71036000|NCT01492439|141580785|SUPERIORITY_OR_OTHER|||||||0.225||||||This applies to semester 2.|t-test, 1 sided|||||||0.225
71036001|NCT01492439|141580786|SUPERIORITY_OR_OTHER|||||||0.247||||||This applies to the 'positive' subscale of the PANSS.|ANCOVA|||||||0.247
71036002|NCT01492439|141580786|SUPERIORITY_OR_OTHER|||||||0.747||||||This applies to the 'negative' subscale of the PANSS.|ANCOVA|||||||0.747
71036003|NCT01492439|141580786|SUPERIORITY_OR_OTHER|||||||0.582||||||This applies to the 'general psychopathology' subscale of the PANSS.|ANCOVA|||||||0.582
71036004|NCT01492439|141580787|SUPERIORITY_OR_OTHER|||||||0|||||||ANCOVA|||||||0.000
71036005|NCT01492439|141580788|SUPERIORITY_OR_OTHER|||||||0.95||||||This applies to the 'positive' subscale of the PANSS.|ANCOVA|||||||0.950
71036006|NCT01492439|141580788|SUPERIORITY_OR_OTHER|||||||0.027||||||This applies to the 'negative' subscale of the PANSS.|ANCOVA|||||||0.027
71036007|NCT01492439|141580788|SUPERIORITY_OR_OTHER|||||||0.639||||||This applies to the 'general psychopathology' subscale of the PANSS.|ANCOVA|||||||0.639
71036008|NCT01492439|141580789|SUPERIORITY_OR_OTHER|||||||0.008|||||||ANCOVA|||||||0.008
71036009|NCT01492439|141580790|SUPERIORITY_OR_OTHER|||||||0.314||||||This applies to Trial 1 on the CVLT.|ANCOVA|||||||0.314
71036010|NCT01492439|141580790|SUPERIORITY_OR_OTHER|||||||0.242||||||This applies to the total score of trials 1-4 (total free recall) of the CVLT.|ANCOVA|||||||0.242
71036011|NCT01492439|141580790|SUPERIORITY_OR_OTHER|||||||0.669||||||This applies to the 'long delay free recall' subtest of the CVLT.|ANCOVA|||||||0.669
71036012|NCT01492439|141580791|SUPERIORITY_OR_OTHER|||||||0.139||||||This applies to the 'trial 1' subtest of the CVLT.|ANCOVA|||||||0.139
70981841|NCT00756002|141472282|SUPERIORITY_OR_OTHER|||||||0.591||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.591
70981842|NCT00756002|141472283|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.015
70981843|NCT00756002|141472284|SUPERIORITY_OR_OTHER|||||||0.097||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.097
71036013|NCT01492439|141580791|SUPERIORITY_OR_OTHER|||||||0.269||||||This applies to the total of trials 1-4 (total free recall) of the CVLT.|ANCOVA|||||||0.269
71036014|NCT01492439|141580791|SUPERIORITY_OR_OTHER|||||||0.666||||||This applies to the 'long delay free recall' subtest of the CVLT.|ANCOVA|||||||0.666
71036015|NCT01492439|141580792|SUPERIORITY_OR_OTHER|||||||0.391|||||||ANCOVA|||||||0.391
71036016|NCT01492439|141580793|SUPERIORITY_OR_OTHER|||||||0.958|||||||ANCOVA|||||||0.958
71036017|NCT01492439|141580794|SUPERIORITY_OR_OTHER|||||||0.754||||||This applies to the 'forward' sequence of the Digit Span Test.|ANCOVA|||||||0.754
70981844|NCT00756002|141472285|SUPERIORITY_OR_OTHER|||||||0.028||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.028
70981845|NCT00756002|141472286|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.003
70981846|NCT00756002|141472287|SUPERIORITY_OR_OTHER|||||||0.111||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.111
70981847|NCT03047005|141472293|SUPERIORITY|Analyses used all available data. Analyses to compare treatments were all intent-to-treat.||||||0.07|||||||Mixed Models Analysis|Analyses were performed for all randomized patients who attended the first treatment session. Model adjusted for stage 1 treatment condition.||||||.07
70981848|NCT03047005|141472294|SUPERIORITY|Analyses used all available data. Analyses to compare treatments were all intent-to-treat.||||||0.01|||||||Mixed Models Analysis|Analyses were performed for all randomized patients who attended the first treatment session. Model adjusted for stage 1 treatment condition.||||||.01
70981849|NCT04899271|141472299|SUPERIORITY|||||||0.807|||||||Chi-squared|||||||0.807
70981850|NCT04899271|141472300|SUPERIORITY|||||||0.746|||||||Chi-squared|||Comparison at month 6||||0.746
70981851|NCT04899271|141472300|SUPERIORITY|||||||0.201|||||||Chi-squared|||Comparison at month 18||||0.201
70981852|NCT04899271|141472301|SUPERIORITY|||||||0.867|||||||Chi-squared|||Comparison at month 6||||0.867
70981853|NCT04899271|141472301|SUPERIORITY|||||||0.769|||||||Chi-squared|||Comparison at month 12||||0.769
70981854|NCT04899271|141472301|SUPERIORITY|||||||0.776|||||||Chi-squared|||Comparison at month 18||||0.776
70981855|NCT04899271|141472302|SUPERIORITY|||||||0.521||||||Assumption of normality was confirmed by Kolmogorov-Smirnov test; the comparison between treatment arms was performed by means of two-sample t-test.|t-test, 2 sided|||Comparison at month 6 for change from baseline||||0.521
70981856|NCT04899271|141472302|SUPERIORITY|||||||0.959||||||Assumption of normality was confirmed by Kolmogorov-Smirnov test; the comparison between treatment arms was performed by means of two-sample t-test.|t-test, 2 sided|||Comparison at month 12 for change from baseline||||0.959
70981857|NCT04899271|141472302|SUPERIORITY|||||||0.773||||||Assumption of normality was confirmed by Kolmogorov-Smirnov test; the comparison between treatment arms was performed by means of two-sample t-test.|t-test, 2 sided|||Comparison at month 18 for change from baseline||||0.773
70981858|NCT04899271|141472303|SUPERIORITY|||||||0.691|||||||t-test, 2 sided|Assumption of normality is confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample t-test.||Comparison at month 6 for change from baseline||||0.691
70981859|NCT04899271|141472303|SUPERIORITY|||||||0.685||||||Assumption of normality is confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample t-test.|t-test, 2 sided|||Comparison at month 12 for change from baseline||||0.685
70981860|NCT04899271|141472303|SUPERIORITY|||||||0.64||||||Assumption of normality is not confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample Mann-Whitney U test|Wilcoxon (Mann-Whitney)|||Comparison at month 18 for change from baseline||||0.640
71036018|NCT01492439|141580794|SUPERIORITY_OR_OTHER|||||||0.518||||||This applies to the 'backward' sequence of the Digit Span Test.|ANCOVA|||||||0.518
71036019|NCT01492439|141580794|SUPERIORITY_OR_OTHER|||||||0.531||||||This applies to the total score (forward+backwards) on the Digit Span Test.|ANCOVA|||||||0.531
71036020|NCT01492439|141580795|SUPERIORITY_OR_OTHER|||||||0.802||||||This applies to the 'forward' sequence of the Digit Span Test.|ANCOVA|||||||0.802
71036021|NCT01492439|141580795|SUPERIORITY_OR_OTHER|||||||0.091||||||This applies to the 'backwards' sequence of the Digit Span Test.|ANCOVA|||||||0.091
71036022|NCT01492439|141580795|SUPERIORITY_OR_OTHER|||||||0.171||||||This applies to the total score (forward + backwards) on the Digit Span Test.|ANCOVA|||||||0.171
71036023|NCT01492439|141580796|SUPERIORITY_OR_OTHER|||||||0.267|||||||ANCOVA|||||||0.267
71036024|NCT01492439|141580797|SUPERIORITY_OR_OTHER|||||||0.527|||||||ANCOVA|||||||0.527
71036025|NCT01492439|141580798|SUPERIORITY_OR_OTHER|||||||0.852||||||This applies to the percentage of perseverative errors on the WCST.|ANCOVA|||||||0.852
71036026|NCT01492439|141580798|SUPERIORITY_OR_OTHER|||||||0.637||||||This applies to the percentage of conceptual level responses on the WCST.|ANCOVA|||||||0.637
71036027|NCT01492439|141580799|SUPERIORITY_OR_OTHER|||||||0.612||||||This applies to the total number of correct categories on the WCST|ANCOVA|||||||0.612
71097125|NCT05890586|141703155|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.83|||||TWO_SIDED|95.0|0.63|1.1|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.10|0.63|
70981861|NCT04899271|141472304|SUPERIORITY|||||||0.867||||||Comparison between treatment arms is performed by means of a Chi-squared test|Chi-squared|||Comparison at month 6||||0.867
70981862|NCT04899271|141472304|SUPERIORITY|||||||0.769||||||Comparison between treatment arms is performed by means of a Chi-squared test|Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared and Fisher's Exact test separated with a /.||Comparison at month 12||||0.769
70981863|NCT04899271|141472304|SUPERIORITY|||||||0.577|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared test.||Comparison at month 18||||0.577
70981864|NCT04899271|141472305|SUPERIORITY|The effect of treatment on the cumulative number of severe hypoglycemic events was evaluated by means of a Cox proportional hazards model. The Andersen-Gill intensity model with model-based variance was utilized.|Hazard Ratio (HR)|1.271||||0.554|TWO_SIDED|95.0|0.573|2.819|||Cox proportional hazards model|Analysis is based on Cox proportional hazards model.||||2.819|0.573|0.554
70981865|NCT04899271|141472307|SUPERIORITY|||||||0.32||||||Assumption of normality is not confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Wilcoxon (Mann-Whitney)|||Comparison at month 6 for change from baseline||||0.320
70981866|NCT04899271|141472307|SUPERIORITY|||||||0.398||||||Assumption of normality is not confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Wilcoxon (Mann-Whitney)|||Comparison at month 12 for change from baseline||||0.398
70981867|NCT04899271|141472307|SUPERIORITY|||||||1||||||Assumption of normality is not confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Wilcoxon (Mann-Whitney)|||Comparison at month 18 for change from baseline||||1.000
70981868|NCT04899271|141472308|SUPERIORITY|||||||0.892||||||Assumption of normality is confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample t-test.|t-test, 2 sided|||Comparison at month 6 for change from baseline||||0.892
70981869|NCT04899271|141472308|SUPERIORITY|||||||0.412||||||Assumption of normality is confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample t-test.|t-test, 2 sided|||Comparison at month 12 for change from baseline||||0.412
70981870|NCT04899271|141472308|SUPERIORITY|||||||0.371||||||Assumption of normality is not confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Wilcoxon (Mann-Whitney)|||Comparison at month 18 for change from baseline||||0.371
70981871|NCT01929083|141472310|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.04
70981872|NCT01929083|141472311|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.003
70981873|NCT01929083|141472312|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|||||P value for incidence of fatigue/malaise|Fisher Exact|||||||0.04
70981874|NCT01929083|141472312|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED|||||p values for incidence of headache|Fisher Exact|||||||0.60
70981875|NCT01929083|141472312|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|||||p value for incidence of mood changes|Fisher Exact|||||||0.23
70981876|NCT01929083|141472312|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|||||p value for incidence of breast tenderness|Fisher Exact|||||||0.23
70981877|NCT01929083|141472312|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||p value for incidence of hypotension|Fisher Exact|||||||0.48
70981878|NCT01929083|141472312|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||p value for incidence of vertigo requiring discontinuation of therapy|Fisher Exact|||||||0.48
70981879|NCT01929083|141472313|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.02
70981880|NCT01929083|141472314|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.002
70981881|NCT01929083|141472315|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED|||||p value for bradycardia|Fisher Exact|||||||0.65
70981882|NCT01929083|141472315|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED|||||p value for burning at infusion site|Fisher Exact|||||||>0.99
70981883|NCT01929083|141472315|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED|||||p value for transient QTc interval \> 500 ms|Fisher Exact|||||||> 0.99
70981884|NCT01929083|141472316|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.43
70981885|NCT01929083|141472317|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.36
70981886|NCT01929083|141472318|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||<0.0001
70981887|NCT01929083|141472319|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.0001
70981888|NCT02586805|141472334|OTHER||% change in mean rate (vs placebo)|-75.609|||<|0.001|TWO_SIDED|95.0|-84.65|-61.243||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1).||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-61.243|-84.650|<0.001
70981889|NCT02586805|141472334|OTHER||% change in mean rate (vs placebo)|-73.271|||<|0.001|TWO_SIDED|95.0|-82.379|-59.456||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-59.456|-82.379|<0.001
70981890|NCT02586805|141472334|OTHER||% change in mean rate (vs placebo)|-86.921|||<|0.001|TWO_SIDED|95.0|-92.828|-76.15||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-76.150|-92.828|<0.001
70981891|NCT02586805|141472335|OTHER||% change in mean rate (vs placebo)|-80.842|||<|0.001|TWO_SIDED|95.0|-89.169|-66.114||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1).||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-66.114|-89.169|<0.001
71036028|NCT01492439|141580800|SUPERIORITY_OR_OTHER|||||||0.156||||||This applies to the percentage of perseverative errors on the WCST.|ANCOVA|||||||0.156
71036029|NCT01492439|141580800|SUPERIORITY_OR_OTHER|||||||0.926||||||This applies to the percentage of conceptual level responses on the WCST.|ANCOVA|||||||0.926
71036030|NCT01492439|141580801|SUPERIORITY_OR_OTHER|||||||0.843|||||||ANCOVA|||This applies to the total number of categories on the WCST.||||0.843
71036031|NCT01492439|141580802|SUPERIORITY_OR_OTHER|||||||0.129||||||This applies to the total number of errors made on the DVT.|ANCOVA|||||||0.129
71036032|NCT01492439|141580803|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANCOVA|||This applies to the total time taken to complete the DVT.||||0.004
71036033|NCT01492439|141580804|SUPERIORITY_OR_OTHER|||||||0.853|||||||ANCOVA|This applies to the total number of errors on the DVT.||||||0.853
71036034|NCT01492439|141580805|SUPERIORITY_OR_OTHER|||||||0.468|||||||ANCOVA|||This applies to the total time taken to complete the DVT.||||0.468
71036035|NCT05523895|141580806|SUPERIORITY||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|1.52||0.2986|TWO_SIDED|95.0|-4.6|1.4|||Mixed Models Analysis|||||1.4|-4.6|0.2986
71036036|NCT05523895|141580806|SUPERIORITY||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|1.49||0.2859|TWO_SIDED|95.0|-4.5|1.3|||Mixed Models Analysis|||||1.3|-4.5|0.2859
71036037|NCT00824291|141580820|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.12||||0.002|TWO_SIDED|95.0|0.78|3.46|||ANCOVA|||||3.46|0.78|0.002
71036038|NCT00824291|141580821|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.33||||0.067|TWO_SIDED|95.0|-0.09|2.76|||ANCOVA|||||2.76|-0.09|0.067
71036039|NCT00824291|141580822|SUPERIORITY_OR_OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
71036040|NCT00824291|141580823|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Cochran-Mantel-Haenszel|||||||0.002
71036041|NCT00824291|141580824|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23||||0.04|TWO_SIDED|95.0|0.01|0.44|||ANCOVA|||||0.44|0.01|0.040
71036042|NCT00824291|141580825|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.26||||0.035|TWO_SIDED|95.0|0.16|4.37|||ANCOVA|||||4.37|0.16|0.035
71036043|NCT00824291|141580826|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.44||||0.041|TWO_SIDED|95.0|0.1|4.78|||ANCOVA|||||4.78|0.10|0.041
71036044|NCT00824291|141580827|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.145|TWO_SIDED|95.0|-0.13|0.91|||ANCOVA|||||0.91|-0.13|0.145
71036045|NCT00395694|141580835|SUPERIORITY_OR_OTHER||Percentage of participants|4.9|||||TWO_SIDED|95.0|1.6|11.1|||||The estimated value represents the percentage of participants with rash events.|||11.1|1.6|
71036046|NCT01648582|141580847|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.57|||||TWO_SIDED|95.0|-0.74|-0.4||||||||-0.40|-0.74|
71036047|NCT01648582|141580847|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.18|||||TWO_SIDED|95.0|-0.35|-0.01||||||||-0.01|-0.35|
71036048|NCT01648582|141580848|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.57|||||TWO_SIDED|95.0|-0.77|-0.38||||||||-0.38|-0.77|
71036049|NCT01648582|141580848|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.13|||||TWO_SIDED|95.0|-0.33|-0.06||||||||-0.06|-0.33|
71036050|NCT01648582|141580849|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||\<7.0% Week 26||||<0.001
71036051|NCT01648582|141580849|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Fisher Exact|||\<7.0 Week 26||||0.004
71036052|NCT01648582|141580849|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||\<=6.5% Week 26||||<0.001
71036053|NCT01648582|141580849|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||\<=6.5% Week 26||||<0.001
71036054|NCT01648582|141580849|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||\<7.0% Week 52||||<0.001
71036055|NCT01648582|141580849|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Fisher Exact|||\<7.0% Week 52||||0.002
71036056|NCT01648582|141580849|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||\<=6.5% Week 52||||<0.001
71036057|NCT01648582|141580849|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||\<=6.5% Week 52||||<0.001
71036058|NCT01648582|141580850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.24||||0.177|TWO_SIDED|95.0|-0.11|0.59|||Mixed Models Analysis|||Week 26||0.59|-0.11|0.177
71036059|NCT01648582|141580850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.88|||<|0.001|TWO_SIDED|95.0|0.53|1.23|||Mixed Models Analysis|||Week 26||1.23|0.53|<0.001
71036060|NCT01648582|141580850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.12||||0.518|TWO_SIDED|95.0|-0.25|0.5|||Mixed Models Analysis|||Week 52||0.50|-0.25|0.518
71036061|NCT01648582|141580850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.82|||<|0.001|TWO_SIDED|95.0|0.45|1.2|||Mixed Models Analysis|||Week 52||1.20|0.45|<0.001
71036062|NCT01648582|141580851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.65|||<|0.001|TWO_SIDED|95.0|0.42|0.88|||Mixed Models Analysis|||Morning pre-meal, Week 26||0.88|0.42|<0.001
70981892|NCT02586805|141472335|OTHER||% change in mean rate (vs placebo)|-74.169|||<|0.001|TWO_SIDED|95.0|-83.733|-58.983||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-58.983|-83.733|<0.001
70981893|NCT02586805|141472335|OTHER||% change in mean rate (vs placebo)|-87.299|||<|0.001|TWO_SIDED|95.0|-93.494|-75.204||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-75.204|-93.494|<0.001
70981894|NCT02586805|141472336|OTHER||% change in mean rate (vs placebo)|-70.497|||<|0.001|TWO_SIDED|95.0|-82.696|-49.699||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-49.699|-82.696|<0.001
70981895|NCT02586805|141472336|OTHER||% change in mean rate (vs placebo)|-73.285|||<|0.001|TWO_SIDED|95.0|-84.316|-54.496||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-54.496|-84.316|<0.001
70981896|NCT02586805|141472336|OTHER||% change in mean rate (vs placebo)|-83.394|||<|0.001|TWO_SIDED|95.0|-91.618|-67.099||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-67.099|-91.618|<0.001
70981897|NCT02586805|141472337|OTHER||% change in mean rate (vs placebo)|-77.622|||<|0.001|TWO_SIDED|95.0|-86.253|-63.572||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1).||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-63.572|-86.253|<0.001
71036063|NCT01648582|141580851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.94|||<|0.001|TWO_SIDED|95.0|0.71|1.17|||Mixed Models Analysis|||Morning pre-meal, Week 26||1.17|0.71|<0.001
71036064|NCT01648582|141580851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.49||||0.024|TWO_SIDED|95.0|-0.92|-0.07|||Mixed Models Analysis|||Morning 2-hours post-meal, Week 26||-0.07|-0.92|0.024
71036065|NCT01648582|141580851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.11||||0.617|TWO_SIDED|95.0|-0.53|0.32|||Mixed Models Analysis|||Morning 2-hours post-meal, Week 26||0.32|-0.53|0.617
71036066|NCT01648582|141580851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.35||||0.055|TWO_SIDED|95.0|-0.7|0.01|||Mixed Models Analysis|||Mid-day pre-meal, Week 26||0.01|-0.70|0.055
71036067|NCT01648582|141580851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.03||||0.855|TWO_SIDED|95.0|-0.32|0.39|||Mixed Models Analysis|||Mid-day pre-meal, Week 26||0.39|-0.32|0.855
71036068|NCT01648582|141580851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.05|||<|0.001|TWO_SIDED|95.0|-1.46|-0.64|||Mixed Models Analysis|||Mid-day 2-hours post-meal, Week 26||-0.64|-1.46|<0.001
71036069|NCT01648582|141580851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.6||||0.004|TWO_SIDED|95.0|-1.01|-0.19|||Mixed Models Analysis|||Mid-day 2-hours post-meal, Week 26||-0.19|-1.01|0.004
71036070|NCT01648582|141580851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.63|||<|0.001|TWO_SIDED|95.0|-0.97|-0.29|||Mixed Models Analysis|||Evening pre-meal, Week 26||-0.29|-0.97|<0.001
71036071|NCT01648582|141580851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.12||||0.489|TWO_SIDED|95.0|-0.45|0.22|||Mixed Models Analysis|||Evening pre-meal, Week 26||0.22|-0.45|0.489
71036072|NCT01648582|141580851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.89|||<|0.001|TWO_SIDED|95.0|-1.3|-0.48|||Mixed Models Analysis|||Evening 2-hours post-meal, Week 26||-0.48|-1.30|<0.001
71036073|NCT01648582|141580851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.47||||0.024|TWO_SIDED|95.0|-0.88|-0.06|||Mixed Models Analysis|||Evening 2-hours post-meal, Week 26||-0.06|-0.88|0.024
71036074|NCT01648582|141580851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.79|||<|0.001|TWO_SIDED|95.0|-1.17|-0.41|||Mixed Models Analysis|||Bedtime, Week 26||-0.41|-1.17|<0.001
71036075|NCT01648582|141580851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.35||||0.067|TWO_SIDED|95.0|-0.73|-0.03|||Mixed Models Analysis|||Bedtime, Week 26||-0.03|-0.73|0.067
71036076|NCT01648582|141580851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.77|||<|0.001|TWO_SIDED|95.0|0.52|1.01|||Mixed Models Analysis|||Morning pre-meal, Week 52||1.01|0.52|<0.001
71036077|NCT01648582|141580851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.06|||<|0.001|TWO_SIDED|95.0|0.82|1.31|||Mixed Models Analysis|||Morning pre-meal, Week 52||1.31|0.82|<0.001
71036078|NCT01648582|141580851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.53||||0.025|TWO_SIDED|95.0|-1.0|-0.07|||Mixed Models Analysis|||Morning 2-hours post-meal, Week 52||-0.07|-1.00|0.025
71036079|NCT01648582|141580851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.21||||0.384|TWO_SIDED|95.0|-0.67|0.26|||Mixed Models Analysis|||Morning 2-hours post-meal, Week 52||0.26|-0.67|0.384
71036080|NCT01648582|141580851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.43||||0.024|TWO_SIDED|95.0|-0.8|-0.06|||Mixed Models Analysis|||Mid-day pre-meal, Week 52||-0.06|-0.80|0.024
71036081|NCT01648582|141580851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.05||||0.783|TWO_SIDED|95.0|-0.32|0.42|||Mixed Models Analysis|||Mid-day pre-meal, Week 52||0.42|-0.32|0.783
71036082|NCT01648582|141580851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.63||||0.004|TWO_SIDED|95.0|-1.07|-0.2|||Mixed Models Analysis|||Mid-day 2-hours post-meal, Week 52||-0.20|-1.07|0.004
71036083|NCT01648582|141580851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.48||||0.029|TWO_SIDED|95.0|-0.92|-0.05|||Mixed Models Analysis|||Mid-day 2-hours post-meal, Week 52||-0.05|-0.92|0.029
71036084|NCT01648582|141580851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.64|||<|0.001|TWO_SIDED|95.0|-1.01|-0.27|||Mixed Models Analysis|||Evening pre-meal, Week 52||-0.27|-1.01|<0.001
71036085|NCT01648582|141580851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.603|TWO_SIDED|95.0|-0.47|0.27|||Mixed Models Analysis|||Evening pre-meal, Week 52||0.27|-0.47|0.603
71036086|NCT01648582|141580851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.83|||<|0.001|TWO_SIDED|95.0|-1.26|-0.41|||Mixed Models Analysis|||Evening 2-hours post-meal, Week 52||-0.41|-1.26|<0.001
71036087|NCT01648582|141580851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.45||||0.039|TWO_SIDED|95.0|-0.87|-0.02|||Mixed Models Analysis|||Evening 2-hours post-meal, Week 52||-0.02|-0.87|0.039
71036088|NCT01648582|141580851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.99|||<|0.001|TWO_SIDED|95.0|-1.39|-0.6|||Mixed Models Analysis|||Bedtime, Week 52||-0.60|-1.39|<0.001
71036089|NCT01648582|141580851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.59||||0.003|TWO_SIDED|95.0|-0.98|-0.2|||Mixed Models Analysis|||Bedtime, Week 52||-0.20|-0.98|0.003
71097126|NCT05890586|141703155|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.54|0.99|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||0.99|0.54|
71097127|NCT05890586|141703155|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.66|1.18|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.18|0.66|
71036090|NCT01648582|141580852|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|34.41|STANDARD_ERROR_OF_MEAN|3.831||0.352|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%B, Dula 1.5 mg, Week 26||||0.352
71036091|NCT01648582|141580852|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|31.17|STANDARD_ERROR_OF_MEAN|3.761||0.352|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%B, Dula 0.75 mg, Week 26||||0.352
71036092|NCT01648582|141580852|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|45.12|STANDARD_ERROR_OF_MEAN|4.147||0.025|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%B, Dula 1.5, Week 52||||0.025
71036093|NCT01648582|141580852|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|36.64|STANDARD_ERROR_OF_MEAN|4.061||0.025|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%B, Dula 0.75 mg, Week 52||||0.025
71036094|NCT01648582|141580853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|36.57|STANDARD_ERROR_OF_MEAN|2.977||0.025|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%S, Dula 1.5 mg, Week 26||||0.025
71036095|NCT01648582|141580853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|30.42|STANDARD_ERROR_OF_MEAN|2.94||0.025|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%S, Dula 0.75 mg, Week 26||||0.025
71036096|NCT01648582|141580853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|41.02|STANDARD_ERROR_OF_MEAN|2.9||0.029|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%S, Dula 1.5 mg, Week 52||||0.029
71036097|NCT01648582|141580853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|35.19|STANDARD_ERROR_OF_MEAN|2.864||0.029|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%S, Dula 0.75 mg, Week 52||||0.029
71036098|NCT01648582|141580856|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||||||Overall p-value|Mixed Models Analysis|||Week 26 SBP||||0.008
71036099|NCT01648582|141580856|SUPERIORITY_OR_OTHER_LEGACY|||||||0.584||||||Overall p-value|Mixed Models Analysis|||Week 26 DBP||||0.584
71036100|NCT01648582|141580856|SUPERIORITY_OR_OTHER_LEGACY|||||||0.169||||||Overall p-value|Mixed Models Analysis|||Week 52 SBP||||0.169
71036101|NCT01648582|141580856|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||||||Overall p-value|Mixed Models Analysis|||Week 52 DBP||||0.110
71036102|NCT01648582|141580857|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Overall p-value|Mixed Models Analysis|||Week 26||||<0.001
71036103|NCT01648582|141580857|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Overall p-value|Mixed Models Analysis|||Week 52||||<0.001
71036104|NCT01648582|141580864|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Week 26|Mixed Models Analysis|||||||<0.001
71097128|NCT05890586|141703156|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.85|1.37|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.37|0.85|
71036105|NCT01648582|141580864|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Week 52||||<0.001
71036106|NCT01648582|141580865|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Week 26||||<0.001
71036107|NCT01648582|141580865|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Week 52||||<0.001
71036108|NCT01058668|141580880|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.1|||<|0.001|TWO_SIDED|95.0|-8.4|-3.8|||Mixed Models Analysis||cariprazine (3-6 mg/day) - placebo|||-3.8|-8.4|<0.001
71036109|NCT01058668|141580880|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.9|||<|0.001|TWO_SIDED|95.0|-8.2|-3.6|||Mixed Models Analysis||cariprazine (6-12 mg/day) - placebo|||-3.6|-8.2|<0.001
71036110|NCT01058668|141580881|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.6|||<|0.001|TWO_SIDED|95.0|-0.9|-0.4|||Mixed Models Analysis||cariprazine (3-6 mg/day) - placebo|||-0.4|-0.9|<0.001
70981898|NCT02586805|141472337|OTHER||% change in mean rate (vs placebo)|-75.377|||<|0.001|TWO_SIDED|95.0|-84.115|-61.833||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1).||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-61.833|-84.115|<0.001
71097129|NCT05890586|141703156|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.85|1.44|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.44|0.85|
70981899|NCT02586805|141472337|OTHER||% change in mean rate (vs placebo)|-89.008|||<|0.001|TWO_SIDED|95.0|-94.325|-78.707||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1).||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-78.707|-94.325|<0.001
70981900|NCT00500071|141472339|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 1||||< 0.0001
70981901|NCT00500071|141472339|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 2||||< 0.0001
70981902|NCT00500071|141472339|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 3||||< 0.0001
70981903|NCT00500071|141472339|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 4||||< 0.0001
70981904|NCT00500071|141472339|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 5||||< 0.0001
70981905|NCT00500071|141472339|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 6||||< 0.0001
70981906|NCT00500071|141472339|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 7||||< 0.0001
70981907|NCT00500071|141472340|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||||||< 0.0001
71036111|NCT01058668|141580881|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.6|||<|0.001|TWO_SIDED|95.0|-0.9|-0.3|||Mixed Models Analysis||cariprazine (6-12 mg/day) - placebo|||-0.3|-0.9|<0.001
71036112|NCT04859517|141580882|SUPERIORITY||Risk Difference (RD)|-5.0||||0.0123|TWO_SIDED|95.0|-8.87|-1.08|||Regression, Logistic||||A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|-1.08|-8.87|0.0123
70981908|NCT00500071|141472343|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||||||< 0.0001
70981909|NCT00500071|141472344|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Global Executive Composite||||< 0.0001
70981910|NCT00500071|141472344|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Behavioral Recognition Index||||< 0.0001
70981911|NCT00500071|141472344|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Metacognition Index||||< 0.0001
70981912|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean neuropathy score from period 1 to period 2 between the two arms."|Difference in Change|-0.32||||0.02|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in neuropathy score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean neuropathy score from period 1 to period 2 between the two arms"||||0.02
70981913|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean problems maintaining an erection score from period 1 to period 2 between the two arms."|Difference in Change|-0.29||||0.11|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in problems maintaining an erection score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean problems maintaining an erection score from period 1 to period 2 between the two arms"||||0.11
70981914|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean dry mouth score from period 1 to period 2 between the two arms."|Difference in Change|-0.29||||0.02|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dry mouth score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean dry mouth score from period 1 to period 2 between the two arms"||||0.02
71036113|NCT04859517|141580883|SUPERIORITY||Risk Difference (RD)|-3.9|||<|0.0001|TWO_SIDED|95.0|-5.75|-2.01|||Regression, Logistic|||||-2.01|-5.75|<0.0001
71036114|NCT04859517|141580886|SUPERIORITY||Standardized Risk Difference|-7.6||||0.0153|TWO_SIDED|95.0|-13.74|-1.46|||Regression, Logistic||||A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|-1.46|-13.74|0.0153
71036115|NCT04859517|141580887|SUPERIORITY||Risk Difference (RD)|-4.4||||0.0612|TWO_SIDED|95.0|-9.03|0.21|||Regression, Logistic||||A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|0.21|-9.03|0.0612
71036116|NCT04859517|141580906|SUPERIORITY||Hazard Ratio (HR)|0.22||||0.0077|TWO_SIDED|95.0|0.06|0.76|||Log Rank|||||0.76|0.06|0.0077
71036117|NCT04859517|141580907|SUPERIORITY||Hazard Ratio (HR)|0.27|||<|0.0001|TWO_SIDED|95.0|0.14|0.49|||Log Rank|||||0.49|0.14|<0.0001
71036118|NCT01068821|141580908|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED|95.0|||||t-test, 2 sided|||Sample size calculations (yielding 25 patients per group): two-sided 5% significance level and a power of 80% for detection of a 2 cm (SD 2.5 cm) difference. Continuous variables analyzed by Student's T-test and One way Analysis of Variance (ANOVA) with statistical significance: p value ≤ 0.05 or 95% Confidence Interval excluding one. Confirmation by Wilcoxon Rank-Sum/Mann-Whitney and Kruskal-Wallis tests. Categorical variables by Chi Square Test, confirmed by Fisher's Exact test.||||0.1
71036119|NCT01068821|141580909|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Fisher Exact|||Fischer's exact test, significance defined as p\<0.05||||0.5
71036120|NCT00908128|141580910|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses of Variance (PROC MIXED) was performed on lon-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|90.96||||||90.0|82.4|100.41|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100.41|82.40|
71036121|NCT00908128|141580911|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses of Variance (PROC MIXED) was performed on log-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|99.16||||||90.0|96.24|102.16|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.16|96.24|
71036122|NCT00908128|141580912|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses of Variance (PROC MIXED) was performed on the log-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|98.78||||||90.0|95.76|101.89|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.89|95.76|
71036123|NCT02842853|141580913|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% Confidence Interval (CI) for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.88|||||TWO_SIDED|95.0|0.751|1.03||||||Serogroup A: Lot 1 vs Lot 2||1.03|0.751|
71097130|NCT05890586|141703156|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.7|1.24|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.24|0.70|
71036124|NCT02842853|141580913|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.985|||||TWO_SIDED|95.0|0.843|1.15||||||Serogroup A: Lot 2 vs Lot 3||1.15|0.843|
71036125|NCT02842853|141580913|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.867|||||TWO_SIDED|95.0|0.74|1.02||||||Serogroup A: Lot 1 vs Lot 3||1.02|0.740|
71036126|NCT02842853|141580913|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|1.07|||||TWO_SIDED|95.0|0.888|1.29||||||Serogroup C: Lot 1 vs Lot 2||1.29|0.888|
71097131|NCT05890586|141703156|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.78|1.37|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.37|0.78|
71036127|NCT02842853|141580913|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.866|||||TWO_SIDED|95.0|0.714|1.05||||||Serogroup C: Lot 2 vs Lot 3||1.05|0.714|
71036128|NCT02842853|141580913|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.927|||||TWO_SIDED|95.0|0.766|1.12||||||Serogroup C: Lot 1 vs Lot 3||1.12|0.766|
71036129|NCT02842853|141580913|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.869|1.19||||||Serogroup Y: Lot 1 vs Lot 2||1.19|0.869|
71036130|NCT02842853|141580913|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.961|||||TWO_SIDED|95.0|0.816|1.13||||||Serogroup Y: Lot 2 vs Lot 3||1.13|0.816|
71036131|NCT02842853|141580913|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.975|||||TWO_SIDED|95.0|0.829|1.15||||||Serogroup Y: Lot 1 vs Lot 3||1.15|0.829|
71036132|NCT02842853|141580913|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|1.04|||||TWO_SIDED|95.0|0.878|1.22||||||Serogroup W: Lot 1 vs Lot 2||1.22|0.878|
71036133|NCT02842853|141580913|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.936|||||TWO_SIDED|95.0|0.791|1.11||||||Serogroup W: Lot 2 vs Lot 3||1.11|0.791|
71036134|NCT02842853|141580913|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.97|||||TWO_SIDED|95.0|0.818|1.15||||||Serogroup W: Lot 1 vs Lot 3||1.15|0.818|
71036135|NCT02842853|141580914|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|19.1|||||TWO_SIDED|95.0|14.8|23.5||||||Serogroup A||23.5|14.8|
70981915|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean ringing in ear score from period 1 to period 2 between the two arms."|Difference in Change|-0.29||||0.01|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in ringing in ear score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean ringing in ear score from period 1 to period 2 between the two arms"||||0.01
70981916|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean vomit score from period 1 to period 2 between the two arms."|Difference in Change|-0.28||||0.01|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in vomit score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean vomit score from period 1 to period 2 between the two arms"||||0.01
70981917|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean dry eyes score from period 1 to period 2 between the two arms."|Difference in Change|-0.24||||0.02|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dry eyes score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean dry eyes score from period 1 to period 2 between the two arms"||||0.02
70981918|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean heartburn score from period 1 to period 2 between the two arms."|Difference in Change|-0.19||||0.11|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in heartburn score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean heartburn score from period 1 to period 2 between the two arms"||||0.11
70981919|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean diarrhea score from period 1 to period 2 between the two arms."|Difference in Change|-0.16||||0.21|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in diarrhea score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean diarrhea score from period 1 to period 2 between the two arms"||||0.21
70981920|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean constipation score from period 1 to period 2 between the two arms."|Difference in Change|-0.14||||0.33|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in constipation score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean constipation score from period 1 to period 2 between the two arms"||||0.33
70981921|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean appetite change score from period 1 to period 2 between the two arms."|Difference in Change|-0.1||||0.46|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in appetite change score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean appetite change score from period 1 to period 2 between the two arms"||||0.46
70981922|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean difficulty remembering score from period 1 to period 2 between the two arms."|Difference in Change|-0.1||||0.46|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty remembering score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean difficulty remembering score from period 1 to period 2 between the two arms"||||0.46
70981923|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean fatigue score from period 1 to period 2 between the two arms."|Difference in Change|-0.07||||0.58|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in fatigue score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean fatigue score from period 1 to period 2 between the two arms"||||0.58
70981924|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean cough score from period 1 to period 2 between the two arms."|Difference in Change|0.01||||0.92|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in cough score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean cough score from period 1 to period 2 between the two arms"||||0.92
71036136|NCT02842853|141580914|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|40.9|||||TWO_SIDED|95.0|36.7|45.0||||||Serogroup C||45|36.7|
71036137|NCT02842853|141580914|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|18.1|||||TWO_SIDED|95.0|14.5|21.9||||||Serogroup Y||21.9|14.5|
70981925|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean urination score from period 1 to period 2 between the two arms."|Difference in Change|0.02||||0.84|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in urination score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean urination score from period 1 to period 2 between the two arms"||||0.84
70981926|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean clumsy score from period 1 to period 2 between the two arms."|Difference in Change|0.03||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in clumsy score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean clumsy score from period 1 to period 2 between the two arms"||||0.83
70981927|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean fever score from period 1 to period 2 between the two arms."|Difference in Change|0.04||||0.72|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in fever score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean fever score from period 1 to period 2 between the two arms"||||0.72
70981928|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean pain during sex score from period 1 to period 2 between the two arms."|Difference in Change|0.06||||0.48|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in pain during sex score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean pain during sex score from period 1 to period 2 between the two arms"||||0.48
70981929|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean dizziness score from period 1 to period 2 between the two arms."|Difference in Change|0.08||||0.54|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dizziness score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean dizziness score from period 1 to period 2 between the two arms"||||0.54
70981930|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean muscle aches score from period 1 to period 2 between the two arms."|Difference in Change|0.09||||0.56|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in muscle aches score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean muscle aches score from period 1 to period 2 between the two arms"||||0.56
70981931|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean speech difficulties score from period 1 to period 2 between the two arms."|Difference in Change|0.1||||0.22|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in speech difficulties score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean speech difficulties score from period 1 to period 2 between the two arms"||||0.22
71036138|NCT02842853|141580914|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|19.1|||||TWO_SIDED|95.0|14.9|23.3||||||Serogroup W||23.3|14.9|
71036139|NCT02842853|141580915|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|19.6|||||TWO_SIDED|95.0|13.5|25.8||||||Serogroup A||25.8|13.5|
71036140|NCT02842853|141580915|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|41.1|||||TWO_SIDED|95.0|35.0|46.9||||||Serogroup C||46.9|35.0|
71036141|NCT02842853|141580915|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|27.4|||||TWO_SIDED|95.0|21.7|33.3||||||Serogroup Y||33.3|21.7|
71036142|NCT02842853|141580915|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|26.8|||||TWO_SIDED|95.0|20.7|32.9||||||Serogroup W||32.9|20.7|
71036143|NCT02842853|141580916|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|18.7|||||TWO_SIDED|95.0|12.5|24.9||||||Serogroup A||24.9|12.5|
71036144|NCT02842853|141580916|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|42.3|||||TWO_SIDED|95.0|36.6|48.0||||||Serogroup C||48.0|36.6|
71036145|NCT02842853|141580916|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|10.0|||||TWO_SIDED|95.0|6.18|14.5||||||Serogroup Y||14.5|6.18|
71036146|NCT02842853|141580916|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|12.5|||||TWO_SIDED|95.0|7.22|18.2||||||Serogroup W||18.2|7.22|
71036147|NCT02842853|141580917|OTHER||Percentage Difference|-5.4|||||TWO_SIDED|95.0|-9.59|-1.16||||||Serogroup A: Lot 1 vs Lot 2||-1.16|-9.59|
71036148|NCT02842853|141580917|OTHER||Percentage Difference|2.9|||||TWO_SIDED|95.0|-1.3|7.01||||||Serogroup A: Lot 2 vs Lot 3||7.01|-1.3|
71036149|NCT02842853|141580917|OTHER||Percentage Difference|-2.5|||||TWO_SIDED|95.0|-6.78|1.74||||||Serogroup A: Lot 1 vs Lot 3||1.74|-6.78|
71036150|NCT02842853|141580917|OTHER||Percentage Difference|1.3|||||TWO_SIDED|95.0|-1.58|4.28||||||Serogroup C: Lot 1 vs Lot 2||4.28|-1.58|
71036151|NCT02842853|141580917|OTHER||Percentage Difference|2.4|||||TWO_SIDED|95.0|-0.74|5.54||||||Serogroup C: Lot 2 vs Lot 3||5.54|-0.740|
71036152|NCT02842853|141580917|OTHER||Percentage Difference|3.7|||||TWO_SIDED|95.0|0.708|6.79||||||Serogroup C: Lot 1 vs Lot 3||6.79|0.708|
71036153|NCT02842853|141580917|OTHER||Percentage Difference|0.5|||||TWO_SIDED|95.0|-2.14|3.07||||||Serogroup Y: Lot 1 vs Lot 2||3.07|-2.14|
71097132|NCT05890586|141703157|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.68|1.05|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.05|0.68|
71097133|NCT05890586|141703157|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.7|1.11|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.11|0.70|
71097134|NCT05890586|141703157|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.72|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.21|0.72|
71036154|NCT02842853|141580917|OTHER||Percentage Difference|2.0|||||TWO_SIDED|95.0|-0.763|4.79||||||Serogroup Y: Lot 2 vs Lot 3||4.79|-0.763|
71036155|NCT02842853|141580917|OTHER||Percentage Difference|2.5|||||TWO_SIDED|95.0|-0.248|5.2||||||Serogroup Y: Lot 1 vs Lot 3||5.20|-0.248|
71036156|NCT02842853|141580917|OTHER||Percentage Difference|0.8|||||TWO_SIDED|95.0|-3.0|4.54||||||Serogroup W: Lot 1 vs Lot 2||4.54|-3.00|
71036157|NCT02842853|141580917|OTHER||Percentage Difference|2.0|||||TWO_SIDED|95.0|-1.84|5.89||||||Serogroup W: Lot 2 vs Lot 3||5.89|-1.84|
71097135|NCT05890586|141703157|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.75|1.29|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.29|0.75|
71097136|NCT05890586|141703158|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio, log|1.3|||||TWO_SIDED|95.0|1.05|1.6|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.60|1.05|
71036158|NCT02842853|141580917|OTHER||Percentage Difference|2.8|||||TWO_SIDED|95.0|-1.02|6.61||||||Serogroup W: Lot 1 vs Lot 3||6.61|-1.02|
71036159|NCT02842853|141580918|OTHER||GMT Ratio|1.93|||||TWO_SIDED|95.0|1.67|2.24||||||Serogroup A||2.24|1.67|
71036160|NCT02842853|141580918|OTHER||GMT Ratio|8.05|||||TWO_SIDED|95.0|6.58|9.84||||||Serogroup C||9.84|6.58|
71036161|NCT02842853|141580918|OTHER||GMT Ratio|3.22|||||TWO_SIDED|95.0|2.71|3.84||||||Serogroup Y||3.84|2.71|
71036162|NCT02842853|141580918|OTHER||GMT Ratio|1.9|||||TWO_SIDED|95.0|1.61|2.24||||||Serogroup W||2.24|1.61|
71036163|NCT00608322|141580988|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.03||||0.37|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.37
71036164|NCT00834444|141580990|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.9||||||90.0|87.8|107.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107|87.8|
71036165|NCT00834444|141580991|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.0||||||90.0|97.9|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103|97.9|
71036166|NCT00834444|141580992|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.0||||||90.0|97.7|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103|97.7|
71036167|NCT03325881|141581027|SUPERIORITY||Difference in LS Mean|-1.9|STANDARD_ERROR_OF_MEAN|2.48||0.451|TWO_SIDED|95.0|-6.8|3.1|||Mixed-effects model for repeated measure|||Number of participants with SHP465 was compared with placebo using the linear mixed-effects model for repeated measures (MMRM) that included treatment group, nominal visit, age group, interaction of the treatment group with the visits as factors, baseline ADHD-RS5 total score as a covariate and an adjustment for the interaction of the baseline ADHD-RS-5 Total Score with the visit.||3.1|-6.8|0.451
71036168|NCT03325881|141581028|SUPERIORITY||Difference in LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.597|TWO_SIDED|95.0|-0.5|0.3|||Mixed-effects model for repeated measure|||Number of participants with SHP465 was compared with placebo using the mixed effects model for repeated measures (MMRM) that includes treatment group, nominal visit, age group,interaction of the treatment group with the visit as factors, baseline CGI-S as a covariate and an adjustment for the interaction of the baseline CGI-S with the visit.||0.3|-0.5|0.597
71036169|NCT03060486|141581041|OTHER||Signed Rank Score Difference|-60.0|||<|0.0001|TWO_SIDED||||||Wilcoxon signed-rank test|||||||<.0001
70981932|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean decreased sex drive score from period 1 to period 2 between the two arms."|Difference in Change|0.11||||0.4|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in decreased sex drive score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean decreased sex drive score from period 1 to period 2 between the two arms"||||0.40
70981933|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean anxiety score from period 1 to period 2 between the two arms."|Difference in Change|0.13||||0.35|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in anxiety score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean anxiety score from period 1 to period 2 between the two arms"||||0.35
70981934|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean difficulty concentrating score from period 1 to period 2 between the two arms."|Difference in Change|0.17||||0.11|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty concentrating score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty concentrating score from period 1 to period 2 between the two arms"||||0.11
70981935|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean shortness of breath score from period 1 to period 2 between the two arms."|Difference in Change|0.2||||0.11|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in shortness of breath score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean shortness of breath score from period 1 to period 2 between the two arms"||||0.11
70981936|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean difficulty falling asleep score from period 1 to period 2 between the two arms."|Difference in Change|0.2||||0.15|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty falling asleep score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty falling asleep score from period 1 to period 2 between the two arms"||||0.15
70981937|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean unplanned changes in weight score from period 1 to period 2 between the two arms."|Difference in Change|0.22||||0.08|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in unplanned changes in weight score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean unplanned changes in weight score from period 1 to period 2 between the two arms"||||0.08
70981938|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean depression score from period 1 to period 2 between the two arms."|Difference in Change|0.34||||0.02|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in depression score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean depression score from period 1 to period 2 between the two arms"||||0.02
70981939|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean difficulty staying asleep score from period 1 to period 2 between the two arms."|Difference in Change|0.36||||0.01|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty staying asleep score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty staying asleep score from period 1 to period 2 between the two arms"||||0.01
70981940|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean dry mouth score from period 1 to period 3 between the two arms."|Difference in Change|-0.27||||0.08|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dry mouth score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean dry mouth score from period 1 to period 3 between the two arms"||||0.08
70981941|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean ringing in ear score from period 1 to period 3 between the two arms."|Difference in Change|-0.24||||0.08|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in ringing in ear score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean ringing in ear score from period 1 to period 3 between the two arms"||||0.08
70981942|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean dry eyes score from period 1 to period 3 between the two arms."|Difference in Change|-0.24||||0.08|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dry eyes score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean dry eyes score from period 1 to period 3 between the two arms"||||0.08
71097137|NCT05890586|141703158|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|1.0|1.52|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.52|1.00|
71097138|NCT05890586|141703158|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.84|1.27|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.27|0.84|
70981943|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean maintaining an erection score from period 1 to period 3 between the two arms."|Difference in Change|-0.13||||0.71|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in maintaining an erection score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean maintaining an erection score from period 1 to period 3 between the two arms"||||0.71
70981944|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean vomit score from period 1 to period 3 between the two arms."|Difference in Change|-0.11||||0.41|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in vomit score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean vomit score from period 1 to period 3 between the two arms"||||0.41
70981945|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean neuropathy score from period 1 to period 3 between the two arms."|Difference in Change|-0.08||||0.84|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in neuropathy score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean neuropathy score from period 1 to period 3 between the two arms"||||0.84
70981946|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean urination score from period 1 to period 3 between the two arms."|Difference in Change|-0.07||||0.71|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in urination score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean urination score from period 1 to period 3 between the two arms"||||0.71
70981947|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean appetite change score from period 1 to period 3 between the two arms."|Difference in Change|-0.05||||0.88|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in appetite change score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean appetite change score from period 1 to period 3 between the two arms"||||0.88
70981948|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean shortness of breath score from period 1 to period 3 between the two arms."|Difference in Change|-0.03||||0.93|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in shortness of breath score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean shortness of breath score from period 1 to period 3 between the two arms"||||0.93
70981949|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean difficulty remembering score from period 1 to period 3 between the two arms."|Difference in Change|-0.03||||0.93|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty remembering score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean difficulty remembering score from period 1 to period 3 between the two arms"||||0.93
70981950|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean muscle aches score from period 1 to period 3 between the two arms."|Difference in Change|-0.03||||0.94|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in muscle aches score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean muscle aches score from period 1 to period 3 between the two arms"||||0.94
71097139|NCT05890586|141703158|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.8|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.21|0.80|
71097140|NCT05890586|141703159|SUPERIORITY||Difference in model estimate time unwell|-0.07|||||TWO_SIDED|95.0|-0.43|0.31|||||The interval is a highest-density credible interval.|Analysis is exploratory. No hypothesis test or decision rule was evaluated.||0.31|-0.43|
70981951|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean diarrhea score from period 1 to period 3 between the two arms."|Difference in Change|0.004||||0.97|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in diarrhea score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean diarrhea score from period 1 to period 3 between the two arms"||||0.97
70981952|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean fatigue score from period 1 to period 3 between the two arms."|Difference in Change|0.01||||0.95|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in fatigue score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean fatigue score from period 1 to period 3 between the two arms"||||0.95
70981953|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean anxiety score from period 1 to period 3 between the two arms."|Difference in Change|0.01||||0.95|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in anxiety score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean anxiety score from period 1 to period 3 between the two arms"||||0.95
70981954|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean constipation score from period 1 to period 3 between the two arms."|Difference in Change|0.03||||0.93|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in constipation score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean constipation score from period 1 to period 3 between the two arms"||||0.93
70981955|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean fever score from period 1 to period 3 between the two arms."|Difference in Change|0.06||||0.84|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in fever score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean fever score from period 1 to period 3 between the two arms"||||0.84
70981956|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean cough score from period 1 to period 3 between the two arms."|Difference in Change|0.07||||0.84|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in cough score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean cough score from period 1 to period 3 between the two arms"||||0.84
71036170|NCT00835614|141581042|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|90.9||||||90.0|87.5|94.4|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||94.4|87.5|
71097141|NCT05890586|141703160|SUPERIORITY||Difference in model estimated means|0.08|||||TWO_SIDED|95.0|-0.37|0.52|||||The interval is a highest-density credible interval.|Analysis is exploratory. No hypothesis test or decision rule was evaluated.||0.52|-0.37|
71097142|NCT00669331|141703235|SUPERIORITY_OR_OTHER||Rate Ratio Mannitol:Control|0.92||||0.3115|TWO_SIDED|95.0|0.78|1.08|||Negative binomial regression model|Negative binomial regression model with treatment, region and baseline PE rate as predictors and log of follow-up time as an offset variable|For rate ratio, Mannitol rate is the numerator, Control rate is the denominator|||1.08|0.78|0.3115
70981957|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean heartburn score from period 1 to period 3 between the two arms."|Difference in Change|0.11||||0.54|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in heartburn score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean heartburn score from period 1 to period 3 between the two arms"||||0.54
70981958|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean pain during sex score from period 1 to period 3 between the two arms."|Difference in Change|0.14||||0.13|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in pain during sex score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean pain during sex score from period 1 to period 3 between the two arms"||||0.13
71036171|NCT00835614|141581043|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|92.1||||||90.0|90.3|93.9|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||93.9|90.3|
71036172|NCT00835614|141581044|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|92.2||||||90.0|90.4|94.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||94|90.4|
71036173|NCT00829712|141581045|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.95||||||90.0|94.02|108.39|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.39|94.02|
71036174|NCT00829712|141581046|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.05||||||90.0|95.08|103.19|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103.19|95.08|
71036175|NCT00829712|141581047|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.94||||||90.0|96.08|103.95|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103.95|96.08|
71036176|NCT00606281|141581048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0|||<|0.001|TWO_SIDED|95.0|-9.4|-2.7|||ANCOVA|||||-2.7|-9.4|<0.001
71036177|NCT00606281|141581049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.001||95.0|-1.1|-0.3|||ANCOVA|||||-0.3|-1.1|<0.001
71036178|NCT02213263|141581072|EQUIVALENCE|Equivalence was tested within the pre-specified margins of (-16%, 16%) 95% confidence interval.|Difference in ORR|4.66|||||TWO_SIDED|95.0|-4.16|13.47||||||Difference in ORR between PF-05280586 and rituximab-EU was computed using the stratified Mantel-Haenszel method. The 95% confidence interval for the difference was calculated using the asymptotic stratified method proposed by Miettinen and Nurminen.||13.47|-4.16|
71036179|NCT02213263|141581078|SUPERIORITY||Hazard Ratio (HR)|1.163||||0.45|TWO_SIDED|95.0|0.786|1.72||A log-rank test stratified by follicular lymphoma international prognostic index 2 (FLIPI2) risk was used to compare the treatment groups with respect to TTF at a 2-sided alpha level of 0.05.|Log Rank||Hazard ratio and its confidence intervals (CIs) were estimated from Cox Proportional hazards model stratified by FLIPI2 risk categorization.|||1.720|0.786|0.450
71036180|NCT02213263|141581079|SUPERIORITY||Hazard Ratio (HR)|1.393||||0.189|TWO_SIDED|95.0|0.847|2.291|||Log Rank|A log-rank test stratified by FLIPI2 risk was used to compare the treatment groups with respect to PFS at a 2-sided alpha level of 0.05.|Hazard ratio and its CIs were estimated from Cox Proportional hazards model stratified by FLIPI2 risk categorization.|||2.291|0.847|0.189
71036181|NCT02213263|141581080|SUPERIORITY||Mean Difference (Final Values)|-2.31|||||TWO_SIDED|95.0|-11.09|6.5||||||Difference in CR between PF-05280586 and rituximab-EU was computed using the stratified Mantel-Haenszel method. The 95% confidence interval for the difference was calculated using the asymptotic stratified method proposed by Miettinen and Nurminen.||6.50|-11.09|
71036182|NCT02213263|141581081|SUPERIORITY||Hazard Ratio (HR)|1.492||||0.185|TWO_SIDED|95.0|0.823|2.704||A log-rank test stratified by FLIPI2 risk was used to compare the treatment groups with respect to DOR at a 2-sided alpha level of 0.05.|Log Rank||Hazard ratio and its CIs were estimated from Cox Proportional hazards model stratified by FLIPI2 risk categorization.|||2.704|0.823|0.185
71036183|NCT02213263|141581082|SUPERIORITY||Hazard Ratio (HR)|2.94||||0.319|TWO_SIDED|95.0|0.0||Due to smaller number of participants with an event, upper limit of 95% CI could not be calculated.|A log-rank test stratified by FLIPI2 risk was used to compare the treatment groups with respect to overall survival at a 2-sided alpha level of 0.05.|Log Rank||Hazard ratio and its CIs were estimated from Cox Proportional hazards model stratified by FLIPI2 risk categorization.||||0.000|0.319
71036184|NCT00909753|141581111|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|92.5||||||90.0|85.8|99.7|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.7|85.8|
71036185|NCT00909753|141581112|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|95.5||||||90.0|92.2|98.9|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||98.9|92.2|
71036186|NCT00909753|141581113|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|90.4||||||90.0|83.1|98.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||98.3|83.1|
71036187|NCT00909753|141581114|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|90.5||||||90.0|85.5|95.9|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||95.9|85.5|
71036188|NCT00909753|141581115|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|92.2||||||90.0|85.5|99.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.5|85.5|
71036189|NCT00909753|141581116|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|95.0||||||90.0|91.3|98.7|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||98.7|91.3|
71036190|NCT00909753|141581117|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|90.4||||||90.0|83.1|98.3|||||Bioequivalence is established when 90% COnfidence Interval falls within 80-125.|||98.3|83.1|
71097143|NCT00669331|141703236|SUPERIORITY_OR_OTHER||LS mean difference across the 52 weeks|-2.4||||0.0457|TWO_SIDED|95.0|-4.76|-0.05|||Mixed model repeated measures analysis|Model included treatment, visit, treatment\*visit, region and baseline SGRQ Total score.|difference calculated Mannitol-control. Negative difference is in favour of mannitol since lower scores indicate improved quality of life.|||-0.05|-4.76|0.0457
71097144|NCT00669331|141703237|SUPERIORITY_OR_OTHER||Rate ratio|0.91||||0.2754|TWO_SIDED|95.0|0.77|1.08|||Negative binomial regression model|Negative binomial regression model with treatment, region and baseline pulmonary exacerbation rate as predictors, log follow-up as offset|Rate ratio is for mannitol vs control.|||1.08|0.77|0.2754
71097145|NCT00669331|141703238|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0218|TWO_SIDED|95.0|0.63|0.96|||Regression, Cox|Cox regression model was stratified by region and baseline PE rate||||0.96|0.63|0.0218
70981959|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean clumsy score from period 1 to period 3 between the two arms."|Difference in Change|0.18||||0.18|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in clumsy score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean clumsy score from period 1 to period 3 between the two arms"||||0.18
70981960|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean difficulty falling asleep score from period 1 to period 3 between the two arms."|Difference in Change|0.19||||0.29|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty falling asleep score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty falling asleep score from period 1 to period 3 between the two arms"||||0.29
71008779|NCT02055976|141525253|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-50.856|STANDARD_ERROR_OF_MEAN|3.451|<|0.001|TWO_SIDED|95.0|-57.709|-44.002|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-44.002|-57.709|<0.001
71008780|NCT02055976|141525253|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.354|STANDARD_ERROR_OF_MEAN|3.505|<|0.001|TWO_SIDED|95.0|-63.315|-49.393|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-49.393|-63.315|<0.001
71008781|NCT02055976|141525253|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-43.172|STANDARD_ERROR_OF_MEAN|3.647|<|0.001|TWO_SIDED|95.0|-50.417|-35.926|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-35.926|-50.417|<0.001
71008782|NCT02055976|141525253|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.698|STANDARD_ERROR_OF_MEAN|3.633|<|0.001|TWO_SIDED|95.0|-63.916|-49.48|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-49.480|-63.916|<0.001
71008783|NCT02055976|141525253|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.305|STANDARD_ERROR_OF_MEAN|3.609|<|0.001|TWO_SIDED|95.0|-68.477|-54.134|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-54.134|-68.477|<0.001
71008784|NCT02055976|141525255|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.69928|STANDARD_ERROR_OF_MEAN|0.13216|<|0.001|TWO_SIDED|95.0|-1.96175|-1.43682|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.43682|-1.96175|<0.001
71008785|NCT02055976|141525255|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.07922|STANDARD_ERROR_OF_MEAN|0.13446|<|0.001|TWO_SIDED|95.0|-2.34622|-1.81223|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.81223|-2.34622|<0.001
71008786|NCT02055976|141525255|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.23886|STANDARD_ERROR_OF_MEAN|0.13553|<|0.001|TWO_SIDED|95.0|-2.50795|-1.96978|||Mixed Models Analysis|||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.96978|-2.50795|<0.001
71008787|NCT02055976|141525255|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.43281|STANDARD_ERROR_OF_MEAN|0.16311|<|0.001|TWO_SIDED|95.0|-1.75689|-1.10872|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.10872|-1.75689|<0.001
71036191|NCT00909753|141581118|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|90.5||||||90.0|85.0|96.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||96.3|85.0|
71036192|NCT02336074|141581126|SUPERIORITY|||||||0.26||||||Treatment arms were compared in terms of absolute total HIV DNA levels (on a log10-scale) at post-randomization weeks 16 and 18 adjusted for the baseline (i.e. randomization) level and by stratum.|Regression, Linear|||||||0.26
71036193|NCT02336074|141581128|SUPERIORITY||Odds Ratio (OR)|0.41||||0.145|TWO_SIDED||||||Regression, Logistic|||"Comparison of the proportion of patients with undetectable viral outgrowth using logistic regression.~The analysis was adjusted for stratum and baseline viral outgrowth. Missing baseline values were imputed."||||0.145
70981961|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean difficulty concentrating score from period 1 to period 3 between the two arms."|Difference in Change|0.2||||0.12|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty concentrating score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty concentrating score from period 1 to period 3 between the two arms"||||0.12
70981962|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean decreased sex drive score from period 1 to period 3 between the two arms."|Difference in Change|0.24||||0.1|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in decreased sex drive score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean decreased sex drive score from period 1 to period 3 between the two arms"||||0.10
70981963|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean speech difficulties score from period 1 to period 3 between the two arms."|Difference in Change|0.25||||0.01|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in speech difficulties score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean speech difficulties score from period 1 to period 3 between the two arms"||||0.01
70981964|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean unplanned changes in weight score from period 1 to period 3 between the two arms."|Difference in Change|0.26||||0.08|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in unplanned changes in weight score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean unplanned changes in weight score from period 1 to period 3 between the two arms"||||0.08
70981965|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean dizziness score from period 1 to period 3 between the two arms."|Difference in Change|0.27||||0.08|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dizziness score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean dizziness score from period 1 to period 3 between the two arms"||||0.08
71036194|NCT02679729|141581134|SUPERIORITY_OR_OTHER||Slope|0.625|||||TWO_SIDED|95.0|0.396|0.853||||||Statistical Analysis for Part A||0.853|0.396|
70981966|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean difficulty staying asleep score from period 1 to period 3 between the two arms."|Difference in Change|0.27||||0.09|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty staying asleep score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty staying asleep score from period 1 to period 3 between the two arms"||||0.09
70981967|NCT03182738|141472368|SUPERIORITY|"Linear mixed models to test difference in mean depression score from period 1 to period 3 between the two arms."|Difference in Change|0.38||||0.05|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in depression score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean depression score from period 1 to period 3 between the two arms"||||0.05
70981968|NCT03182738|141472369|SUPERIORITY|Linear mixed models to test difference in mean score of Fatigue PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|-2.09||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||The parameter was estimated using a difference in change in Fatigue PROMIS T-score from baseline to 3 months between two arms|The null hypothesis is that there is no difference in change in Fatigue PROMIS T-score from baseline to 3 months between two arms||||0.83
71036195|NCT02679729|141581135|SUPERIORITY_OR_OTHER||Slope|1.2|||||TWO_SIDED|95.0|0.905|1.49||||||Statistical Analysis for Part A||1.49|0.905|
71036196|NCT02679729|141581136|SUPERIORITY_OR_OTHER||Slope|1.55|||||TWO_SIDED|95.0|1.34|1.76||||||Statistical Analysis for Part A||1.76|1.34|
71036197|NCT00836758|141581150|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.007
71036198|NCT00906399|141581152|SUPERIORITY_OR_OTHER||Rate Ratio|0.725||||0.0114|TWO_SIDED|95.0|0.565|0.93|||Negative Binomial Regression|Based on negative binomial regression, with adjustment for baseline EDSS (\< 4 versus ≥ 4), baseline relapse rate, age (\< 40 versus ≥ 40 years).||||0.930|0.565|0.0114
71036199|NCT00906399|141581152|SUPERIORITY_OR_OTHER||Rate Ratio|0.644||||0.0007|TWO_SIDED|95.0|0.5|0.831|||Negative Binomial Regression|Based on negative binomial regression, with adjustment for baseline EDSS (\< 4 versus ≥ 4), baseline relapse rate, age (\< 40 versus ≥ 40).||||0.831|0.500|0.0007
71036200|NCT00906399|141581153|SUPERIORITY_OR_OTHER||Lesion Mean Ratio|0.72||||0.0008|TWO_SIDED|95.0|0.6|0.87|||Negative Binomial Regression|Lesion mean ratio (95% CI) and p-value based on negative binomial regression, adjusted for baseline number of T2 lesions.||||0.87|0.60|0.0008
70981969|NCT03182738|141472369|SUPERIORITY|Linear mixed models to test difference in mean score of Anxiety PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|-0.94||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||The parameter was estimated using a difference in change in Anxiety PROMIS T-score from baseline to 3 months between two arms|The null hypothesis is that there is no difference in change in Anxiety PROMIS T-score from baseline to 3 months between two arms||||0.83
70981970|NCT03182738|141472369|SUPERIORITY|Linear mixed models to test difference in mean score of Depression PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|-0.79||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||The parameter was estimated using a difference in change in Depression PROMIS T-score from baseline to 3 months between two arms|The null hypothesis is that there is no difference in change in Depression PROMIS T-score from baseline to 3 months between two arms||||0.83
70981971|NCT03182738|141472369|SUPERIORITY|Linear mixed models to test difference in mean score of Pain Interference PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|-0.78||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||The parameter was estimated using a difference in change in Pain Interference PROMIS T-score from baseline to 3 months between two arms|The null hypothesis is that there is no difference in change in Pain Interference PROMIS T-score from baseline to 3 months between two arms||||0.83
70981972|NCT03182738|141472369|SUPERIORITY|Linear mixed models to test difference in mean score of Satisfaction with Social Role PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|0.04||||0.98|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Satisfaction with Social Role PROMIS T-score from baseline to 3 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm"|The null hypothesis is that there is no difference in change in Satisfaction with Social Role PROMIS T-score from baseline to 3 months between two arms||||0.98
70981973|NCT03182738|141472369|SUPERIORITY|Linear mixed models to test difference in mean score of Physical Function PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|0.55||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Physical Function PROMIS T-score from baseline to 3 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Physical Function PROMIS T-score from baseline to 3 months between two arms.||||0.83
70981974|NCT03182738|141472369|SUPERIORITY|Linear mixed models to test difference in mean score of Sleep Disturbance PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|0.84||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Sleep Disturbance PROMIS T-score from baseline to 3 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Sleep Disturbance PROMIS T-score from baseline to 3 months between two arms.||||0.83
70981975|NCT03182738|141472369|SUPERIORITY|Linear mixed models to test difference in mean score of Physical Function PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|-0.43||||0.96|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||The parameter was estimated using a difference in change in Physical Function PROMIS T-score from baseline to 6 months between two arms.|The null hypothesis is that there is no difference in change in Physical Function PROMIS T-score from baseline to 6 months between two arms.||||0.96
70981976|NCT03182738|141472369|SUPERIORITY|Linear mixed models to test difference in mean score of Depression PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|0.07||||0.96|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Depression PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Depression PROMIS T-score from baseline to 6 months between two arms.||||0.96
70981977|NCT03182738|141472369|SUPERIORITY|Linear mixed models to test difference in mean score of Satisfaction with Social Role PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|0.23||||0.96|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model|||The null hypothesis is that there is no difference in change in Satisfaction with Social Role PROMIS T-score from baseline to 6 months between two arms.|"The parameter was estimated using a difference in change in Satisfaction with Social Role PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|||0.96
70981978|NCT03182738|141472369|SUPERIORITY|Linear mixed models to test difference in mean score of Anxiety PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|0.77||||0.96|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Anxiety PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Anxiety PROMIS T-score from baseline to 6 months between two arms.||||0.96
71036201|NCT00906399|141581153|SUPERIORITY_OR_OTHER||Lesion Mean Ratio|0.33|||<|0.0001|TWO_SIDED|95.0|0.27|0.4|||Negative Binomial Regression|Lesion mean ratio (95% CI) and p-value based on negative binomial regression, adjusted for baseline number of T2 lesions.||||0.40|0.27|<0.0001
71036202|NCT00906399|141581154|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.02|TWO_SIDED|95.0|0.57|0.95||Based on Cox proportion hazards model, adjusted for baseline EDSS (\< 4 versus ≥ 4), age (\<40 versus ≥ 40 years), baseline relapse rate, and baseline Gd enhancing lesions (presence versus absence).|Cox Proportion Hazards model|||||0.95|0.57|0.0200
70981979|NCT03182738|141472369|SUPERIORITY|Linear mixed models to test difference in mean score of Pain Interference PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|1.05||||0.96|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Pain Interference PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Pain Interference PROMIS T-score from baseline to 6 months between two arms.||||0.96
70981980|NCT03182738|141472369|SUPERIORITY|Linear mixed models to test difference in mean score of Fatigue PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|1.5||||0.96|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Fatigue PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Fatigue PROMIS T-score from baseline to 6 months between two arms.||||0.96
70981981|NCT03182738|141472369|SUPERIORITY|Linear mixed models to test difference in mean score of Sleep Disturbance PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|2.04||||0.64|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Sleep Disturbance PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Sleep Disturbance PROMIS T-score from baseline to 6 months between two arms.||||0.64
70981982|NCT00356915|141472404|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|This was stratified by analysis center.||P-Value from a Cochran-Mantel-Haenszel test, . The superiority analysis was restricted to the itraconazole 200-mg tablets and placebo tablets dosing groups.||||<0.001
70981983|NCT00356915|141472405|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority was established if the lower limit of the one-sided, 97.5% CI in the observed difference between the proportions of subjects by study drug with Complete Cure at week 52 (itraconazole 200-mg tablets minus itraconazole 100-mg capsules) was greater than -10%. No p-value was calculated for this endpoint.|Wald's CI|0.56|||||ONE_SIDED|97.5|-4.3||||Wald's CI|The statistical analysis used Wald's CI with Yates' continuity correction.||Comparison between the 2 itraconazole groups was based on lower bound of the 97.5% confidence interval for the difference. The non-inferiority analysis was restricted to the active dosing groups.|||-4.3|
70981984|NCT00356915|141472406|NON_INFERIORITY_OR_EQUIVALENCE|The assumption was that the Complete Cure rate at week 52 was 35% for the active dosing groups, a sample size of 552 ITT subjects per active group would have had a 93% power for testing the proportion of subjects with Complete Cure. These computations assumed a non inferiority margin of 10% and a one-sided significance level of 0.025. Power computations were performed using nQuery Advisor, Version 5.0.|Mean Difference (Final Values)|10.0|||<|0.001|ONE_SIDED|97.5|-1.1||||Wald's CI|The statistical analysis used Wald's CI with Yates' continuity correction.||The test for demonstrating non-inferiority was based on a margin of 10%. Thus, non-inferiority was established if the lower limit of the one-sided, 97.5% CI in the observed difference between the proportions of subjects by study drug with Complete Cure at week 52 (itraconazole 200-mg tablets minus itraconazole 100-mg capsules) was greater than -10%. The non-inferiority analysis was restricted to the active dosing groups.|||-1.1|< 0.001
70981985|NCT00356915|141472407|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|This was stratified by analysis center.||The superiority analysis was restricted to the itraconazole 200-mg tablets and placebo tablets dosing groups.||||<0.001
70981986|NCT00509106|141472408|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% Confidence Interval (CI) for the observed difference in the primary outcome measure (clinical cure rate) between the ceftaroline group and the ceftriaxone group was calculated based on the MITTE Population at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10% for the MITTE populations.|Risk Difference (RD)|5.9|||||TWO_SIDED|95.0|-1.0|12.7|||||Risk difference corresponds to Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The confidence interval was calculated using the Miettinen and Nurminen method without adjustment.|The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared with that for ceftriaxone at TOC in the MITTE Population in adult subjects with CABP.||12.7|-1.0|
70981987|NCT00488631|141472439|SUPERIORITY_OR_OTHER|||||||0.01||||||A fixed sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level (i.e., testing golimumab 100 mg vs. placebo first, then, if positive, testing 50 mg vs. placebo).|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants in clinical response through Week 54 were summarized using the Cochran-Mantel-Haenszel (CMH) test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.010
70981988|NCT00488631|141472439|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level (i.e., testing golimumab 100 mg vs. placebo first, then, if positive, testing 50 mg vs. placebo).|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants in clinical response through Week 54 were summarized using the Cochran-Mantel-Haenszel (CMH) test stratified by clinical remission status at Week 0 and the induction dose factor.||||<0.001
70981989|NCT00488631|141472440|SUPERIORITY_OR_OTHER|||||||0.122||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at both Week 30 and Week 54 were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.122
70981990|NCT00488631|141472440|SUPERIORITY_OR_OTHER|||||||0.004||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at both Week 30 and Week 54 were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.004
71036203|NCT00906399|141581154|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.0003|TWO_SIDED|95.0|0.47|0.8||Based on Cox proportion hazards model, adjusted for baseline EDSS (\< 4 versus ≥ 4), age (\<40 versus ≥ 40 years), baseline relapse rate, and baseline Gd enhancing lesions (presence versus absence).|Cox Proportion Hazards model|||||0.80|0.47|0.0003
71036204|NCT00906399|141581155|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.038|TWO_SIDED|95.0|0.4|0.97||Based on Cox Proportional Hazards model, adjusted for baseline EDSS (\< 4 versus ≥ 4) and age (\< 40 versus ≥ 40 years).|Cox Proportion Hazards model|||||0.97|0.40|0.0380
71036205|NCT00906399|141581155|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.0383|TWO_SIDED|95.0|0.4|0.97||Based on Cox Proportional Hazards model, adjusted for baseline EDSS (\< 4 versus ≥ 4) and age (\< 40 versus ≥ 40 years).|Cox Proportion Hazards model|||||0.97|0.40|0.0383
71036206|NCT01124786|141581156|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.994|||<|0.973|TWO_SIDED|95.0|0.746|1.326|||Log Rank||Hazard ratio and confidence interval presented above, so parameter dispersion not indicated in standard deviation field directly above.|If the median Overall Survival (OS) for the CO-1.01-treated patients is 7.7 months and the median OS for gemcitabine-treated patients with hENT1-low status is 4 months (hazard ratio of 0.53), then a total of 144 events of death in the hENT1-low subgroup will provide over 90% power at a 0.05 (2 sided) significance level for the comparison of CO-1.01 to gemcitabine in the hENT1-low patients.||1.326|0.746|<0.973
71036207|NCT02055547|141581227|OTHER|Treatment comparison (MK-8521 125μg - placebo) of the slope of ISR/G during GGI at Tmax was performed using a linear mixed effect model with treatment and period as fixed effects and participant as random effect. The 90% confidence interval of GMR of the slope of ISR/G for MK-8521 125μg vs. placebo was calculated from the model.|Geometric mean ratio|4.61|||<|0.001|TWO_SIDED|90.0|3.69|5.76|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3 period crossover study design was conducted for 12 participants in Part 3).|5.76|3.69|<0.001
71036208|NCT02055547|141581227|OTHER|Treatment comparison (MK-8521 35μg - placebo) of the slope of ISR/G during GGI at Tmax was performed using a linear mixed effect model with treatment and period as fixed effects and participant as random effect. The 90% confidence interval of GMR of the slope of ISR/G for MK-8521 35μg vs. placebo was calculated from the model.|Geometric mean ratio|2.67|||<|0.001|TWO_SIDED|90.0|2.12|3.36|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3 period crossover study design was conducted for 12 participants in Part 3).|3.36|2.12|<0.001
71036209|NCT02055547|141581227|OTHER|"Treatment comparison (MK-8521 125μg - MK-8521 35μg) of the slope of ISR/G during GGI at Tmax was performed using a linear mixed effect model with treatment and period as fixed effects and participant as random effect. The 90% confidence interval of GMR of the slope of ISR/G for MK-8521 125μg vs.~MK-8521 35μg was calculated from the model."|Geometric mean ratio|1.73|||<|0.001|TWO_SIDED|90.0|1.38|2.16|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3 period crossover study design was conducted for 12 participants in Part 3).|2.16|1.38|<0.001
71036210|NCT02055547|141581228|OTHER|Treatment comparison (MK-8521 125μg - placebo) of the ratio of ISR/G during GGI at Tmax was performed using a linear mixed effect model with treatment and period as fixed effects and participant as random effect. The 90% confidence interval of GMR of TWA120-160min of ratio (ISR/G) for MK-8521 125μg vs. placebo was calculated from the model.|Geometric mean ratio|3.04|||<|0.001|TWO_SIDED|90.0|2.62|3.53|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3-period crossover study design was conducted for 12 participants in Part 3).|3.53|2.62|<0.001
71036211|NCT02055547|141581228|OTHER|Treatment comparison (MK-8521 35μg - placebo) of the ratio of ISR/G during GGI at Tmax was performed using a linear mixed effect model with treatment and period as fixed effects and participant as random effect. The 90% confidence interval of GMR of TWA120-160min of ratio (ISR/G) for MK-8521 35μg vs. placebo was calculated from the model.|Geometric mean ratio|1.94|||<|0.001|TWO_SIDED|90.0|1.67|2.26|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3-period crossover study design was conducted for 12 participants in Part 3).|2.26|1.67|<0.001
71036212|NCT02055547|141581228|OTHER|Treatment comparison (MK-8521 125μg - 35μg) of the ratio of ISR/G during GGI at Tmax was performed using a linear mixed effect model with treatment and period as fixed effects and participant as random effect. The 90% confidence interval of GMR of TWA120-160min of ratio (ISR/G) for MK-8521 125μg - 35μg was calculated from the model.|Geometric mean ratio|1.57|||<|0.001|TWO_SIDED|90.0|1.35|1.82|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3-period crossover study design was conducted for 12 participants in Part 3).|1.82|1.35|<0.001
71036213|NCT02055547|141581229|OTHER|The least squares means and 90% confidence intervals for the treatment difference (MK-8521 125mcg - placebo) in glucose (TWA0-160min) after a single dose was determined using a linear mixed effect model with treatment and period as fixed effects and participant as random effect.|Geometric mean ratio|0.65|||<|0.001|TWO_SIDED|90.0|0.6|0.7|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3-period crossover study design was conducted for 12 participants in Part 3).|0.7|0.6|<0.001
71097146|NCT00669331|141703239|SUPERIORITY_OR_OTHER||Rate ratio|0.88||||0.3602|TWO_SIDED|95.0|0.67|1.16|||Negative binomial model|treatment, region and baseline pulmonary exacerbation rate as predictors, and with log of follow-up time as the offset variable||Analysed using a negative binomial model with treatment, region and baseline pulmonary exacerbation rate as predictors, and with log of follow-up time as the offset variable||1.16|0.67|0.3602
71097147|NCT00669331|141703240|SUPERIORITY_OR_OTHER||ls mean difference across 52 weeks|2.76||||0.0355|TWO_SIDED|95.0|0.19|5.33|||Mixed Models Analysis|Model includes treatment, visit, treatment\*visit, region and baseline sputum weight (g).|Difference mannitol-control|||5.33|0.19|0.0355
71036214|NCT02055547|141581229|OTHER|The least squares means and 90% confidence intervals for the treatment difference (MK-8521 35μg - placebo) in glucose (TWA0-160min) after a single dose was determined using a linear mixed effect model with treatment and period as fixed effects and participant as random effect.|Geometric mean ratio|0.8|||<|0.001|TWO_SIDED|90.0|0.74|0.87|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3-period crossover study design was conducted for 12 participants in Part 3).|0.87|0.74|<0.001
71036215|NCT02055547|141581229|OTHER|The least squares means and 90% confidence intervals for the treatment difference (MK-8521 125μg - MK-8521 35μg) in glucose (TWA0-160min) after a single dose was determined using a linear mixed effect model with treatment and period as fixed effects and participant as random effect.|Geometric mean ratio|0.81|||<|0.001|TWO_SIDED|90.0|0.75|0.87|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3-period crossover study design was conducted for 12 participants in Part 3).|0.87|0.75|<0.001
71036216|NCT02055547|141581230|OTHER|The least squares means and 90% confidence intervals for the treatment difference (MK-8521 125μg vs. placebo) in Gmax after a single dose was determined using a linear mixed effect model with treatment and period as fixed effects and participant as random effect.|Geometric mean ratio|0.55|||<|0.001|TWO_SIDED|90.0|0.49|0.63|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3 period crossover study design was conducted for 12 participants in Part 3).|0.63|0.49|<0.001
71036217|NCT02055547|141581230|OTHER|The least squares means and 90% confidence intervals for the treatment difference (MK-8521 35μg - placebo) in Gmax after a single dose was determined using a linear mixed effect model with treatment and period as fixed effects and participant as random effect.|Geometric mean ratio|0.71|||<|0.001|TWO_SIDED|90.0|0.62|0.81|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3 period crossover study design was conducted for 12 participants in Part 3).|0.81|0.62|<0.001
71036218|NCT02055547|141581230|OTHER|The least squares means and 90% confidence intervals for the treatment difference (MK-8521 125μg - MK-8521 35μg) in Gmax after a single dose was determined using a linear mixed effect model with treatment and period as fixed effects and participant as random effect.|Geometric mean ratio|0.78||||0.004|TWO_SIDED|90.0|0.69|0.89|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3 period crossover study design was conducted for 12 participants in Part 3).|0.89|0.69|0.004
71036219|NCT03067987|141581237|SUPERIORITY||||||<|0.007|||||||ANOVA|||||||<0.007
71036220|NCT03067987|141581238|SUPERIORITY|||||||0.0006|||||||ANOVA|||||||0.0006
71036221|NCT00834275|141581241|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.0||||||90.0|94.0|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||104|94|
71036222|NCT00834275|141581242|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|98.3|105.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||105|98.3|
71036223|NCT00834275|141581243|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|98.3|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||104|98.3|
71036224|NCT00829764|141581244|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|93.52||||||90.0|88.49|98.83|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||98.83|88.49|
71036225|NCT00829764|141581245|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.75||||||90.0|93.98|101.67|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101.67|93.98|
71036226|NCT00829764|141581246|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.46||||||90.0|94.78|102.28|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||102.28|94.78|
71036227|NCT01750294|141581247|SUPERIORITY_OR_OTHER|||||||0.01||||||a = 0.05|Mixed Models Analysis|||||||0.01
71036228|NCT00907907|141581366|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (PROC MIXED) were performed on the log-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|93.97||||||90.0|80.25|110.04|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||110.04|80.25|
71036229|NCT00907907|141581367|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses of Variance (PROC MIXED) were performed on the log-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|102.01||||||90.0|98.74|105.39|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.39|98.74|
71036230|NCT00907907|141581368|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses of Variance (PROC MIXED) were performed on the log-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|99.91||||||90.0|95.99|103.98|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.98|95.99|
71036231|NCT00545792|141581370|SUPERIORITY_OR_OTHER||Single point estiamte of 1-yr PFS|0.8|||||TWO_SIDED|95.0|0.56|0.94|||||The reported 1-year PFS rate 80% (Exact 95% CI: 56% - 94%) was the proportion of the patients remained progression free after 12 months.|Single-arm feasibility study; Kaplan Meier analysis was applied to estimate one-year PFS distribution as well as to calculate proportion of patients remain progression free by month 12.||0.94|0.56|
71036232|NCT03779334|141581380|SUPERIORITY||||||<|0.0001|||||||Exact Binomial Test|Performance Criterion = 5%||||||<0.0001
71036233|NCT01175135|141581408|OTHER||Least Squares (LS) Mean Difference|-2.21|STANDARD_ERROR_OF_MEAN|2.683||0.2053|TWO_SIDED|80.0|-5.66|1.24||Reported p-value was 1-sided.|Mixed Models Analysis|||Mixed effect repeated measures (MMRM) model with fixed effect for baseline PANSS total score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS total score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||1.24|-5.66|0.2053
71036234|NCT01175135|141581408|OTHER||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|2.698||0.4024|TWO_SIDED|80.0|-4.14|2.8||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline PANSS total score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS total score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||2.80|-4.14|0.4024
71036235|NCT01175135|141581408|OTHER||LS Mean Difference|-8.24|STANDARD_ERROR_OF_MEAN|3.453||0.009|TWO_SIDED|80.0|-12.68|-3.8||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline PANSS total score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS total score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||-3.80|-12.68|0.0090
71036236|NCT01175135|141581409|OTHER||Difference in Proportion|-0.03|||||TWO_SIDED|80.0|-0.07|0.01|||||The adjusted 80% Confidence Interval (CI) equals 88.6% CI, adjusted due to 1 interim look.|||0.01|-0.07|
71036237|NCT01175135|141581409|OTHER||Difference in Proportion|0.04|||||TWO_SIDED|80.0|-0.02|0.1|||||The adjusted 80% CI equals 88.6% CI, adjusted due to 1 interim look.|||0.10|-0.02|
71036238|NCT01175135|141581409|OTHER||Difference in Proportion|-0.04|||||TWO_SIDED|80.0|-0.08|0.0|||||The adjusted 80% CI equals 88.6% CI, adjusted due to 1 interim look.|||-0.00|-0.08|
71036239|NCT01175135|141581410|OTHER||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.845||0.3144|TWO_SIDED|80.0|-1.5|0.68||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS positive subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS positive subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||0.68|-1.50|0.3144
71036240|NCT01175135|141581410|OTHER||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.854||0.57|TWO_SIDED|80.0|-0.95|1.25||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS positive subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS positive subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||1.25|-0.95|0.5700
71036241|NCT01175135|141581410|OTHER||LS Mean Difference|-2.99|STANDARD_ERROR_OF_MEAN|1.093||0.0034|TWO_SIDED|80.0|-4.4|-1.59||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS positive subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS positive subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||-1.59|-4.40|0.0034
71036242|NCT01175135|141581410|OTHER||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.73||0.0942|TWO_SIDED|80.0|-1.9|-0.02||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS negative subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS negative subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||-0.02|-1.90|0.0942
71097148|NCT00669331|141703241|SUPERIORITY_OR_OTHER||LS mean diff across post-baseline visits|-0.44||||0.1159|TWO_SIDED|95.0|-0.99|0.11|||Mixed Models Analysis|Model includes treatment, visit, treatment\*visit, region and baseline ESS score|Negative change indicates an improvement in ESS score. Difference calculated Mannitol - Control.|||0.11|-0.99|0.1159
71097149|NCT00669331|141703242|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.56||||0.6677|TWO_SIDED|95.0|-27.01|42.13|||Mixed Models Analysis|Model of absolute change from baseline in FEV1. Model includes terms for treatment, visit, trt\*visit, region and baseline value|ls mean difference Mannitol-Control|||42.13|-27.01|0.6677
71097150|NCT00669331|141703249|SUPERIORITY_OR_OTHER||Rate ratio|0.61||||0.0928|TWO_SIDED|95.0|0.34|1.09|||Negative binomial regression|||||1.09|0.34|0.0928
71097151|NCT03300336|141703272|SUPERIORITY||Odds Ratio (OR)|0.77||||0.01|TWO_SIDED|95.0|0.64|0.93||a priori threshold for statistical significance p \<.05|generalized linear model|generalized linear model with a logit link and a binomial distribution|Odds in intervention numerator vs odds in usual care denominator|Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the 7 post-baseline timepoints), and a site-level random effect. Model was not adjusted for patient characteristics. Estimated means and standard errors are provided in Outcome Measure Data table.||0.93|0.64|0.01
71036243|NCT01175135|141581410|OTHER||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.735||0.203|TWO_SIDED|80.0|-1.56|0.33||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS negative subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS negative subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||0.33|-1.56|0.2030
71036244|NCT01175135|141581410|OTHER||LS Mean Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.944||0.0907|TWO_SIDED|80.0|-2.48|-0.05||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS negative subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS negative subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||-0.05|-2.48|0.0907
71036245|NCT01175135|141581410|OTHER||LS Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|1.33||0.2904|TWO_SIDED|80.0|-2.45|0.97||Reported p-value was 1-sided.|Mixed Models Analysis|||General Score: MMRM model with fixed effect for baseline PANSS general subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS general subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||0.97|-2.45|0.2904
71036246|NCT01175135|141581410|OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.339||0.471|TWO_SIDED|80.0|-1.82|1.62||Reported p-value was 1-sided.|Mixed Models Analysis|||General Score: MMRM model with fixed effect for baseline PANSS general subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS general subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||1.62|-1.82|0.4710
71036247|NCT01175135|141581410|OTHER||LS Mean Difference|-3.66|STANDARD_ERROR_OF_MEAN|1.718||0.0172|TWO_SIDED|80.0|-5.86|-1.45||Reported p-value was 1-sided.|Mixed Models Analysis|||General Score: MMRM model with fixed effect for baseline PANSS general subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS general subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||-1.45|-5.86|0.0172
70981991|NCT00488631|141472441|SUPERIORITY_OR_OTHER|||||||0.011||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with mucosal healing at both Week 30 and Week 54 were summarized using CMH test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.011
70981992|NCT00488631|141472441|SUPERIORITY_OR_OTHER|||||||0.002||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with mucosal healing at both Week 30 and Week 54 were summarized using CMH test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.002
70981993|NCT00488631|141472442|SUPERIORITY_OR_OTHER|||||||0.365||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at both Week 30 and 54 among participants with clinical remission at Week 0 of maintenance study were summarized using CMH test stratified by the induction dose factor.||||0.365
70981994|NCT00488631|141472442|SUPERIORITY_OR_OTHER|||||||0.098||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at both Week 30 and 54 among participants with clinical remission at Week 0 of maintenance study were summarized using CMH test stratified by the induction dose factor.||||0.098
70981995|NCT00488631|141472443|SUPERIORITY_OR_OTHER|||||||0.279||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at Week 54 and not receiving concomitant corticosteroids among participants on corticosteroids at Week 0 of maintenance study were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.279
71036248|NCT01175135|141581411|OTHER||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.154||0.197|TWO_SIDED|80.0|-0.33|0.07||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline CGI-S, investigator site, treatment, visit, treatment by visit interaction, a baseline CGI-S by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||0.07|-0.33|0.1970
71036249|NCT01175135|141581411|OTHER||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.154||0.3835|TWO_SIDED|80.0|-0.24|0.15||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline CGI-S, investigator site, treatment, visit, treatment by visit interaction, a baseline CGI-S by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||0.15|-0.24|0.3835
71036250|NCT01175135|141581411|OTHER||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.199||0.0395|TWO_SIDED|80.0|-0.61|-0.1||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline CGI-S, investigator site, treatment, visit, treatment by visit interaction, a baseline CGI-S by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||-0.10|-0.61|0.0395
70981996|NCT00488631|141472443|SUPERIORITY_OR_OTHER|||||||0.423||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at Week 54 and not receiving concomitant corticosteroids among participants on corticosteroids at Week 0 of maintenance study were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.423
70981997|NCT01873950|141472444|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||For each ECG biomarker and treatment, the null hypothesis is that there is no difference in the biomarker change from baseline between the treatment and placebo.|Mixed Models Analysis|For each ECG biomarker and treatment, the placebo-corrected change from baseline was computed using linear mixed effect model.||||||<0.05
70981998|NCT01873950|141472445|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||For each ECG biomarker and treatment, the null hypothesis is that there is no difference in the biomarker change from baseline between the treatment and placebo.|Mixed Models Analysis|For each ECG biomarker and treatment, the placebo-corrected change from baseline was computed using linear mixed effect model.||||||<0.05
71036251|NCT01175135|141581412|OTHER||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.863||0.1999|TWO_SIDED|80.0|-1.84|0.38||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS Marder positive score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder positive score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.38|-1.84|0.1999
71036252|NCT01175135|141581412|OTHER||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.87||0.3399|TWO_SIDED|80.0|-1.48|0.76||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS Marder positive score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder positive score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.76|-1.48|0.3399
71097152|NCT03300336|141703273|SUPERIORITY||rate ratio|1.05||||0.25|TWO_SIDED|95.0|0.97|1.15||a priori threshold for statistical significance p\<.05|generalized linear model|generalized linear model with a log link and negative binomial distribution.|The rate ratio compares the intervention rate in the numerator vs the usual care rate in the denominator|Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the 7 post-baseline time points), a site-level random effect and random effects for each of the time periods. Model was not adjusted for patient characteristics. Estimated means and standard errors are provided in Outcome Measure Data table.||1.15|0.97|0.25
70981999|NCT01873950|141472446|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||For each ECG biomarker and treatment, the null hypothesis is that there is no difference in the biomarker change from baseline between the treatment and placebo.|Mixed Models Analysis|For each ECG biomarker and treatment, the placebo-corrected change from baseline was computed using linear mixed effect model.||||||<0.05
70982000|NCT01193335|141472457|SUPERIORITY_OR_OTHER||Percent difference|-2.0|||||TWO_SIDED|95.0|-7.65|2.88||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||2.88|-7.65|
70982001|NCT01193335|141472457|SUPERIORITY_OR_OTHER||Percent difference|-14.9|||||TWO_SIDED|95.0|-26.4|-3.21||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||-3.21|-26.40|
70982002|NCT01193335|141472457|SUPERIORITY_OR_OTHER||Percent difference|0.06|||||TWO_SIDED|95.0|-5.84|6.05||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||6.05|-5.84|
70982003|NCT01193335|141472457|SUPERIORITY_OR_OTHER||Percent difference|2.06|||||TWO_SIDED|95.0|-1.71|7.25||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||7.25|-1.71|
70982004|NCT01193335|141472457|SUPERIORITY_OR_OTHER||Percent difference|2.12|||||TWO_SIDED|95.0|-4.09|8.89||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||8.89|-4.09|
71036253|NCT01175135|141581412|OTHER||LS Mean Difference|-2.62|STANDARD_ERROR_OF_MEAN|1.117||0.01|TWO_SIDED|80.0|-4.06|-1.18||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS Marder positive score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder positive score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||-1.18|-4.06|0.0100
71036254|NCT01175135|141581412|OTHER||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.778||0.1625|TWO_SIDED|80.0|-1.77|0.23||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS Marder negative score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder negative score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.23|-1.77|0.1625
70982005|NCT01193335|141472457|SUPERIORITY_OR_OTHER||Percent difference|0.02|||||TWO_SIDED|95.0|-4.54|4.68||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.68|-4.54|
70982006|NCT01193335|141472457|SUPERIORITY_OR_OTHER||Percent difference|-6.92|||||TWO_SIDED|95.0|-16.19|1.89||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||1.89|-16.19|
70982007|NCT01193335|141472457|SUPERIORITY_OR_OTHER||Percent difference|-1.94|||||TWO_SIDED|95.0|-9.07|4.86||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.86|-9.07|
70982008|NCT01193335|141472457|SUPERIORITY_OR_OTHER||Percent difference|-4.86|||||TWO_SIDED|95.0|-14.4|4.39||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.39|-14.40|
70982009|NCT01193335|141472457|SUPERIORITY_OR_OTHER||Percent difference|-19.0|||||TWO_SIDED|95.0|-30.1|-7.16||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||-7.16|-30.10|
70982010|NCT01193335|141472457|SUPERIORITY_OR_OTHER||Percent difference|-12.19|||||TWO_SIDED|95.0|-21.66|-3.26||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||-3.26|-21.66|
71036255|NCT01175135|141581412|OTHER||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.783||0.2354|TWO_SIDED|80.0|-1.57|0.44||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS Marder negative score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder negative score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.44|-1.57|0.2354
70982011|NCT01193335|141472457|SUPERIORITY_OR_OTHER||Percent difference|0.02|||||TWO_SIDED|95.0|-4.54|4.68||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.68|-4.54|
70982012|NCT01193335|141472457|SUPERIORITY_OR_OTHER||Percent difference|0.02|||||TWO_SIDED|95.0|-4.54|4.68||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.68|-4.54|
70982013|NCT01193335|141472458|SUPERIORITY_OR_OTHER||GMC ratio|0.8|||||TWO_SIDED|95.0|0.62|1.02||||||Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.02|0.62|
70982014|NCT01193335|141472458|SUPERIORITY_OR_OTHER||GMC ratio|0.56|||||TWO_SIDED|95.0|0.38|0.82||||||Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.82|0.38|
70982015|NCT01193335|141472458|SUPERIORITY_OR_OTHER||GMC ratio|0.74|||||TWO_SIDED|95.0|0.59|0.93||||||Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.93|0.59|
71097153|NCT03300336|141703274|SUPERIORITY||Mean Difference (Net)|1.32||||0.52|TWO_SIDED|95.0|-2.7|5.33||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care group: 5 out of 227 Missing data due to item nonresponse in intervention group: 18 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||5.33|-2.70|0.52
70982016|NCT01193335|141472458|SUPERIORITY_OR_OTHER||GMC ratio|1.23|||||TWO_SIDED|95.0|0.92|1.65||||||Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.65|0.92|
70982017|NCT01193335|141472458|SUPERIORITY_OR_OTHER||GMC ratio|1.0|||||TWO_SIDED|95.0|0.8|1.25||||||Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.25|0.80|
70982018|NCT01193335|141472458|SUPERIORITY_OR_OTHER||GMC ratio|0.72|||||TWO_SIDED|95.0|0.58|0.9||||||Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.90|0.58|
70982019|NCT01193335|141472458|SUPERIORITY_OR_OTHER||GMC ratio|0.64|||||TWO_SIDED|95.0|0.47|0.86||||||Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.86|0.47|
70982020|NCT01193335|141472458|SUPERIORITY_OR_OTHER||GMC ratio|0.7|||||TWO_SIDED|95.0|0.55|0.89||||||Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.89|0.55|
70982021|NCT01193335|141472458|SUPERIORITY_OR_OTHER||GMC ratio|0.96|||||TWO_SIDED|95.0|0.77|1.19||||||Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.19|0.77|
70982022|NCT01193335|141472458|SUPERIORITY_OR_OTHER||GMC ratio|0.54|||||TWO_SIDED|95.0|0.4|0.72||||||Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.72|0.40|
70982023|NCT01193335|141472458|SUPERIORITY_OR_OTHER||GMC ratio|0.61|||||TWO_SIDED|95.0|0.45|0.82||||||Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.82|0.45|
70982024|NCT01193335|141472458|SUPERIORITY_OR_OTHER||GMC ratio|0.71|||||TWO_SIDED|95.0|0.57|0.88||||||Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.88|0.57|
70982025|NCT01193335|141472458|SUPERIORITY_OR_OTHER||GMC ratio|0.85|||||TWO_SIDED|95.0|0.68|1.07||||||Serotype 19: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.07|0.68|
70982026|NCT01193335|141472467|SUPERIORITY_OR_OTHER|||||||0.668|TWO_SIDED||||||Fisher Exact|||AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.668
70982027|NCT01193335|141472467|SUPERIORITY_OR_OTHER|||||||0.051|TWO_SIDED||||||Fisher Exact|||SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.051
70982028|NCT01193335|141472468|SUPERIORITY_OR_OTHER|||||||0.704|TWO_SIDED||||||Fisher Exact|||AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.704
70982029|NCT01193335|141472468|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED||||||Fisher Exact|||SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||>0.99
70982030|NCT01193335|141472469|SUPERIORITY_OR_OTHER|||||||0.531|TWO_SIDED||||||Fisher Exact|||AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.531
70982031|NCT01193335|141472469|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED||||||Fisher Exact|||SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||>0.99
70982032|NCT01193335|141472470|SUPERIORITY_OR_OTHER|||||||0.183|TWO_SIDED||||||Fisher Exact|||AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.183
70982033|NCT01193335|141472470|SUPERIORITY_OR_OTHER|||||||0.357|TWO_SIDED||||||Fisher Exact|||SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.357
70982034|NCT01193335|141472471|SUPERIORITY_OR_OTHER|||||||0.794|TWO_SIDED||||||Fisher Exact|||AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.794
70982035|NCT01193335|141472471|SUPERIORITY_OR_OTHER|||||||0.782|TWO_SIDED||||||Fisher Exact|||SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.782
70982036|NCT01193335|141472472|SUPERIORITY_OR_OTHER||GMFR Ratio|0.85|||||TWO_SIDED|95.0|0.63|1.14||||||Serotype 4: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.14|0.63|
70982037|NCT01193335|141472472|SUPERIORITY_OR_OTHER||GMFR ratio|1.24|||||TWO_SIDED|95.0|0.95|1.62||||||Serotype 6B: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.62|0.95|
70982038|NCT01193335|141472472|SUPERIORITY_OR_OTHER||GMFR ratio|1.19|||||TWO_SIDED|95.0|0.96|1.47||||||Serotype 9V: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.47|0.96|
71036256|NCT01175135|141581412|OTHER||LS Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|1.002||0.2161|TWO_SIDED|80.0|-2.08|0.5||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS Marder negative score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder negative score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.50|-2.08|0.2161
70982039|NCT01193335|141472472|SUPERIORITY_OR_OTHER||GMFR ratio|0.97|||||TWO_SIDED|95.0|0.74|1.26||||||Serotype 14: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.26|0.74|
71036257|NCT01175135|141581412|OTHER||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.627||0.248|TWO_SIDED|80.0|-1.23|0.38||Reported p-value was 1-sided.|Mixed Models Analysis|||Disorganized Thought Score: MMRM model with fixed effect for baseline PANSS Marder disorganized thought score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder disorganized thought score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.38|-1.23|0.2480
71036258|NCT01175135|141581412|OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.632||0.4345|TWO_SIDED|80.0|-0.92|0.71||Reported p-value was 1-sided.|Mixed Models Analysis|||Disorganized Thought Score: MMRM model with fixed effect for baseline PANSS Marder disorganized thought score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder disorganized thought score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.71|-0.92|0.4345
71036259|NCT01175135|141581412|OTHER||LS Mean Difference|-1.48|STANDARD_ERROR_OF_MEAN|0.813||0.0346|TWO_SIDED|80.0|-2.53|-0.44||Reported p-value was 1-sided.|Mixed Models Analysis|||Disorganized Thought Score: MMRM model with fixed effect for baseline PANSS Marder disorganized thought score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder disorganized thought score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||-0.44|-2.53|0.0346
71097154|NCT03300336|141703275|SUPERIORITY||Mean Difference (Net)|1.56||||0.66|TWO_SIDED|95.0|-3.14|6.25||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care group: 5 out of 227 Missing data due to item nonresponse in intervention group: 18 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||6.25|-3.14|0.66
71097155|NCT03300336|141703276|SUPERIORITY||Mean Difference (Net)|-0.52||||0.81|TWO_SIDED|95.0|-4.74|3.7||a priori threshold for significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect.. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care group: 5 out of 227 Missing data due to item nonresponse in intervention group: 14 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||3.70|-4.74|0.81
70982040|NCT01193335|141472472|SUPERIORITY_OR_OTHER||GMFR ratio|0.8|||||TWO_SIDED|95.0|0.63|1.02||||||Serotype 18C: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.02|0.63|
70982041|NCT01193335|141472472|SUPERIORITY_OR_OTHER||GMFR ratio|0.88|||||TWO_SIDED|95.0|0.65|1.19||||||Serotype 19F: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.19|0.65|
70982042|NCT01193335|141472472|SUPERIORITY_OR_OTHER||GMFR ratio|1.0|||||TWO_SIDED|95.0|0.74|1.33||||||Serotype 23F: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale.||1.33|0.74|
70982043|NCT01193335|141472472|SUPERIORITY_OR_OTHER||GMFR ratio|0.84|||||TWO_SIDED|95.0|0.64|1.11||||||Serotype 1: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale.||1.11|0.64|
70982044|NCT01193335|141472472|SUPERIORITY_OR_OTHER||GMFR ratio|1.46|||||TWO_SIDED|95.0|1.03|2.05||||||Serotype 3: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||2.05|1.03|
70982045|NCT01193335|141472472|SUPERIORITY_OR_OTHER||GMFR ratio|1.0|||||TWO_SIDED|95.0|0.81|1.24||||||Serotype 5: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.24|0.81|
71097156|NCT03300336|141703277|SUPERIORITY||Odds Ratio (OR)|1.13||||0.74|TWO_SIDED|95.0|0.55|2.32||a priori threshold for statistical significance p\<.05|generalized linear model|generalized linear model with a logit link and a binomial distribution|Odds in intervention numerator vs odds in usual care denominator|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 0 out of 227 Missing data due to item nonresponse in intervention: 5 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||2.32|0.55|0.74
71097157|NCT03300336|141703278|SUPERIORITY||Mean Difference (Net)|0.02||||0.4|TWO_SIDED|95.0|-0.03|0.06||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 14 out of 227 Missing data due to item nonresponse in intervention: 33 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||0.06|-0.03|0.40
71097158|NCT03300336|141703279|SUPERIORITY||Mean Difference (Net)|0.03||||0.18|TWO_SIDED|95.0|-0.01|0.07||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 7 out of 227 Missing data due to item nonresponse in intervention: 23 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||0.07|-0.01|0.18
70982046|NCT01193335|141472472|SUPERIORITY_OR_OTHER||GMFR ratio|1.36|||||TWO_SIDED|95.0|1.02|1.82||||||Serotype 6A: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.82|1.02|
70982047|NCT01193335|141472472|SUPERIORITY_OR_OTHER||GMFR ratio|0.96|||||TWO_SIDED|95.0|0.78|1.18||||||Serotype 7F: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.18|0.78|
70982048|NCT01193335|141472472|SUPERIORITY_OR_OTHER||GMFR ratio|1.15|||||TWO_SIDED|95.0|0.88|1.52||||||Serotype 19A: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.52|0.88|
70982049|NCT01193335|141472474|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
71097159|NCT03300336|141703280|SUPERIORITY||Mean Difference (Net)|0.8||||0.83|TWO_SIDED|95.0|-6.38|7.98||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 1 out of 227 Missing data due to item nonresponse in intervention: 4 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||7.98|-6.38|0.83
70982050|NCT01193335|141472474|SUPERIORITY_OR_OTHER||Percent difference|-2.33|||||TWO_SIDED|95.0|-8.15|1.96||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||1.96|-8.15|
70982051|NCT01193335|141472474|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
70982052|NCT01193335|141472474|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
70982053|NCT01193335|141472474|SUPERIORITY_OR_OTHER||Percent difference|1.15|||||TWO_SIDED|95.0|-3.13|6.24||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||6.24|-3.13|
70982054|NCT01193335|141472474|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
70982055|NCT01193335|141472474|SUPERIORITY_OR_OTHER||Percent difference|-1.16|||||TWO_SIDED|95.0|-6.32|3.1||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||3.10|-6.32|
70982056|NCT01193335|141472474|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
70982057|NCT01193335|141472474|SUPERIORITY_OR_OTHER||Percent difference|-8.72|||||TWO_SIDED|95.0|-21.93|4.42||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.42|-21.93|
70982058|NCT01193335|141472474|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
70982059|NCT01193335|141472474|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
70982060|NCT01193335|141472474|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
70982061|NCT01193335|141472474|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
70982062|NCT01193335|141472476|SUPERIORITY_OR_OTHER||GMC Ratio|0.76|||||TWO_SIDED|95.0|0.6|0.97||||||Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the ratio difference of the logarithms of the measures.||0.97|0.60|
70982063|NCT01193335|141472476|SUPERIORITY_OR_OTHER||GMC Ratio|0.51|||||TWO_SIDED|95.0|0.39|0.66||||||Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.66|0.39|
70982064|NCT01193335|141472476|SUPERIORITY_OR_OTHER||GMC Ratio|0.64|||||TWO_SIDED|95.0|0.51|0.8||||||Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.80|0.51|
70982065|NCT01193335|141472476|SUPERIORITY_OR_OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.66|1.12||||||Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the ratio difference of the logarithms of the measures.||1.12|0.66|
70982066|NCT01193335|141472476|SUPERIORITY_OR_OTHER||GMC Ratio|1.06|||||TWO_SIDED|95.0|0.85|1.32||||||Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the ratio difference of the logarithms of the measures.||1.32|0.85|
70982067|NCT01193335|141472476|SUPERIORITY_OR_OTHER||GMC Ratio|0.73|||||TWO_SIDED|95.0|0.58|0.92||||||Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the ratio difference of the logarithms of the measures.||0.92|0.58|
70982068|NCT01193335|141472476|SUPERIORITY_OR_OTHER||GMC Ratio|0.6|||||TWO_SIDED|95.0|0.43|0.83||||||Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.83|0.43|
70982069|NCT01193335|141472476|SUPERIORITY_OR_OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.77|1.2||||||Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.20|0.77|
70982070|NCT01193335|141472476|SUPERIORITY_OR_OTHER||GMC Ratio|0.6|||||TWO_SIDED|95.0|0.41|0.87||||||Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.87|0.41|
70982071|NCT01193335|141472476|SUPERIORITY_OR_OTHER||GMC Ratio|0.7|||||TWO_SIDED|95.0|0.56|0.88||||||Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.88|0.56|
70982072|NCT01193335|141472476|SUPERIORITY_OR_OTHER||GMC Ratio|0.54|||||TWO_SIDED|95.0|0.41|0.7||||||Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.70|0.41|
70982073|NCT01193335|141472476|SUPERIORITY_OR_OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.71|1.03||||||Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.03|0.71|
70982074|NCT01193335|141472476|SUPERIORITY_OR_OTHER||GMC Ratio|0.55|||||TWO_SIDED|95.0|0.42|0.72||||||Serotype 19A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.72|0.42|
70982075|NCT01193335|141472477|SUPERIORITY_OR_OTHER||GMC Ratio|0.65|||||TWO_SIDED|95.0|0.51|0.82||||||Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.82|0.51|
70982076|NCT01193335|141472477|SUPERIORITY_OR_OTHER||GMC Ratio|0.61|||||TWO_SIDED|95.0|0.47|0.79||||||Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.79|0.47|
70982077|NCT01193335|141472477|SUPERIORITY_OR_OTHER||GMC Ratio|0.75|||||TWO_SIDED|95.0|0.61|0.93||||||Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.93|0.61|
70982078|NCT01193335|141472477|SUPERIORITY_OR_OTHER||GMC Ratio|0.84|||||TWO_SIDED|95.0|0.66|1.07||||||Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.07|0.66|
70982079|NCT01193335|141472477|SUPERIORITY_OR_OTHER||GMC Ratio|0.84|||||TWO_SIDED|95.0|0.66|1.08||||||Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.08|0.66|
70982080|NCT01193335|141472477|SUPERIORITY_OR_OTHER||GMC Ratio|0.63|||||TWO_SIDED|95.0|0.48|0.83||||||Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.83|0.48|
71097160|NCT03300336|141703281|SUPERIORITY||Mean Difference (Net)|1.46||||0.25|TWO_SIDED|95.0|-1.05|3.96||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 2 out of 227 Missing data due to item nonresponse in intervention: 6 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||3.96|-1.05|0.25
71097161|NCT03300336|141703282|SUPERIORITY||Odds Ratio (OR)|1.16||||0.59|TWO_SIDED|95.0|0.68|1.99||a priori threshold for statistical significance p\<.05|generalized linear model|generalized linear model with a logit link and a binomial distribution|Odds in intervention numerator vs odds in usual care denominator|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 1 out of 227 Missing data due to item nonresponse in intervention: 3 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||1.99|0.68|0.59
71097162|NCT03300336|141703283|SUPERIORITY||Mean Difference (Net)|0.99||||0.47|TWO_SIDED|95.0|-1.71|3.69||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 11 out of 227 Missing data due to item nonresponse in intervention: 20 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||3.69|-1.71|0.47
71097163|NCT03300336|141703284|SUPERIORITY||Mean Difference (Net)|-0.07||||0.94|TWO_SIDED|95.0|-1.76|1.62||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 2 out of 227 Missing data due to item nonresponse in intervention group: 7 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||1.62|-1.76|0.94
71097164|NCT00710554|141703291|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|-0.34||||0.139|TWO_SIDED|95.0|-0.79|0.11|||ANCOVA|||The model used for the analysis of the end of study value was an analysis of covariance (ANCOVA) with baseline value as a covariate and treatment group and centre group as main effect. Due to the low power of the test for interaction, the test was performed at the 10% significance level as a possible indicator of an interactive effect. The null hypothesis was one of no difference between treatments.||0.11|-0.79|0.139
71097165|NCT00710554|141703292|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-2.86||||0.198|TWO_SIDED|95.0|-7.22|1.5|||ANCOVA|||The change from baseline in mean Neuropathic Pain Scale score was compared between treatment groups and centres using ANCOVA. The model was to include treatment and centre group as factors and baseline mean usage as a covariate.||1.50|-7.22|0.198
71097166|NCT00710554|141703293|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.83||||0.007|TWO_SIDED|95.0|-1.43|-0.23|||ANCOVA|||The change from baseline score was compared between treatment groups and centres using ANCOVA. The model was to include treatment and centre group as factors and baseline mean usage as a covariate.||-0.23|-1.43|0.007
70982081|NCT01193335|141472477|SUPERIORITY_OR_OTHER||GMC Ratio|0.61|||||TWO_SIDED|95.0|0.46|0.79||||||Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.79|0.46|
70982082|NCT01193335|141472477|SUPERIORITY_OR_OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.64|1.03||||||Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.03|0.64|
70982083|NCT01193335|141472477|SUPERIORITY_OR_OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.73|1.15||||||Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.15|0.73|
70982084|NCT01193335|141472477|SUPERIORITY_OR_OTHER||GMC Ratio|0.71|||||TWO_SIDED|95.0|0.58|0.87||||||Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.87|0.58|
70982085|NCT01193335|141472477|SUPERIORITY_OR_OTHER||GMC Ratio|0.72|||||TWO_SIDED|95.0|0.57|0.9||||||Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.90|0.57|
70982086|NCT01193335|141472477|SUPERIORITY_OR_OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.69|1.0||||||Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.00|0.69|
70982087|NCT01193335|141472477|SUPERIORITY_OR_OTHER||GMC Ratio|0.63|||||TWO_SIDED|95.0|0.49|0.81||||||Serotype 19A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.81|0.49|
70982088|NCT01193335|141472478|SUPERIORITY_OR_OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.63|1.04||||||Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.04|0.63|
70922811|NCT04950127|141336682|SUPERIORITY||Mean Difference (Net)|-0.53||||0.024|TWO_SIDED|95.0|-0.98|-0.07||Adjusted for multiplicity as per Statistical Analysis Plan (SAP)|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline Monthly sleep score (MSS), Visit\*Baseline MSS interaction, Baseline Concomitant Itch Medication.||-0.07|-0.98|0.024
70982089|NCT01193335|141472478|SUPERIORITY_OR_OTHER||GMC Ratio|0.63|||||TWO_SIDED|95.0|0.48|0.83||||||Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.83|0.48|
70982090|NCT01193335|141472478|SUPERIORITY_OR_OTHER||GMC Ratio|0.62|||||TWO_SIDED|95.0|0.46|0.84||||||Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.84|0.46|
70982091|NCT01193335|141472478|SUPERIORITY_OR_OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.61|1.12||||||Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.12|0.61|
70982092|NCT01193335|141472478|SUPERIORITY_OR_OTHER||GMC Ratio|0.5|||||TWO_SIDED|95.0|0.37|0.67||||||Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.67|0.37|
70982093|NCT01193335|141472478|SUPERIORITY_OR_OTHER||GMC Ratio|0.54|||||TWO_SIDED|95.0|0.4|0.72||||||Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.72|0.40|
70982094|NCT01193335|141472478|SUPERIORITY_OR_OTHER||GMC Ratio|0.47|||||TWO_SIDED|95.0|0.35|0.64||||||Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.64|0.35|
70982095|NCT01193335|141472478|SUPERIORITY_OR_OTHER||GMC Ratio|0.76|||||TWO_SIDED|95.0|0.61|0.94||||||Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.94|0.61|
70982096|NCT01193335|141472478|SUPERIORITY_OR_OTHER||GMC Ratio|0.59|||||TWO_SIDED|95.0|0.39|0.9||||||Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.90|0.39|
70982097|NCT01193335|141472478|SUPERIORITY_OR_OTHER||GMC Ratio|0.67|||||TWO_SIDED|95.0|0.52|0.87||||||Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.87|0.52|
70982098|NCT01193335|141472478|SUPERIORITY_OR_OTHER||GMC Ratio|0.68|||||TWO_SIDED|95.0|0.52|0.88||||||Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.88|0.52|
70982099|NCT01193335|141472478|SUPERIORITY_OR_OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.67|1.02||||||Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.02|0.67|
70982100|NCT01193335|141472478|SUPERIORITY_OR_OTHER||GMC Ratio|0.51|||||TWO_SIDED|95.0|0.36|0.72||||||Serotype 19A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.72|0.36|
70982101|NCT01193335|141472479|SUPERIORITY_OR_OTHER||GMC Ratio|0.8|||||TWO_SIDED|95.0|0.61|1.03||||||Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.03|0.61|
70982102|NCT01193335|141472479|SUPERIORITY_OR_OTHER||GMC Ratio|0.53|||||TWO_SIDED|95.0|0.38|0.76||||||Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.76|0.38|
70982103|NCT01193335|141472479|SUPERIORITY_OR_OTHER||GMC Ratio|0.74|||||TWO_SIDED|95.0|0.54|1.03||||||Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.03|0.54|
70982104|NCT01193335|141472479|SUPERIORITY_OR_OTHER||GMC Ratio|0.77|||||TWO_SIDED|95.0|0.51|1.17||||||Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.17|0.51|
70922812|NCT04950127|141336683|SUPERIORITY||Percentage difference|4.0||||0.539||95.0|-9.0|17.0||Adjusted for multiplicity as per Statistical Analysis Plan (SAP)|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel (CMH) stratified analysis adjusted for baseline factors: Baseline Itch Severity (Moderate: \>=4 and less than \[\<\]7, Severe: \>=7); Concomitant cholestatic pruritus treatment regimen (Regimen contains Bile Acid Binding Resin \[BABR\], Regimen does not contain BABR, No defined treatment). Multiple imputation of missing Monthly itch scores was done before deriving responder definitions. Imputed datasets were analyzed using the CMH method and combined.||17.0|-9.0|0.539
71036260|NCT01175135|141581412|OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.495||0.4685|TWO_SIDED|80.0|-0.68|0.6||Reported p-value was 1-sided.|Mixed Models Analysis|||Uncontrolled hostility/excitement Score: MMRM model with fixed effect for baseline PANSS Marder hostility/excitement score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder hostility/excitement score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.60|-0.68|0.4685
71097167|NCT00710554|141703294|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.08||||0.795|TWO_SIDED|95.0|-0.52|0.68|||ANCOVA|||The change in the dynamic allodynia pain score from baseline to the end of treatment was analysed using ANCOVA with the baseline value as a covariate and country and treatment group as factors.||0.68|-0.52|0.795
70982105|NCT01193335|141472479|SUPERIORITY_OR_OTHER||GMC Ratio|0.56|||||TWO_SIDED|95.0|0.4|0.78||||||Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.78|0.40|
70982106|NCT01193335|141472479|SUPERIORITY_OR_OTHER||GMC Ratio|0.45|||||TWO_SIDED|95.0|0.29|0.71||||||Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.71|0.29|
70982107|NCT01193335|141472479|SUPERIORITY_OR_OTHER||GMC Ratio|0.56|||||TWO_SIDED|95.0|0.38|0.83||||||Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.83|0.38|
70982108|NCT01193335|141472479|SUPERIORITY_OR_OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.63|1.07||||||Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.07|0.63|
70982109|NCT01193335|141472479|SUPERIORITY_OR_OTHER||GMC Ratio|0.66|||||TWO_SIDED|95.0|0.39|1.11||||||Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.11|0.39|
70982110|NCT01193335|141472479|SUPERIORITY_OR_OTHER||GMC Ratio|0.68|||||TWO_SIDED|95.0|0.5|0.92||||||Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.92|0.50|
70982111|NCT01193335|141472479|SUPERIORITY_OR_OTHER||GMC Ratio|0.67|||||TWO_SIDED|95.0|0.47|0.95||||||Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.95|0.47|
70982112|NCT01193335|141472479|SUPERIORITY_OR_OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.7|1.13||||||Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.13|0.70|
70982113|NCT01193335|141472479|SUPERIORITY_OR_OTHER||GMC Ratio|0.53|||||TWO_SIDED|95.0|0.37|0.78||||||Serotype 19A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.78|0.37|
70982114|NCT01193335|141472485|SUPERIORITY_OR_OTHER||GMT Ratio|1.3|||||TWO_SIDED|95.0|0.99|1.81||||||Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.81|0.99|
70982115|NCT01193335|141472485|SUPERIORITY_OR_OTHER||GMT Ratio|1.1|||||TWO_SIDED|95.0|0.59|2.2||||||Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.20|0.59|
70982116|NCT01193335|141472485|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.26|1.93||||||Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.93|0.26|
70982117|NCT01193335|141472485|SUPERIORITY_OR_OTHER||GMT Ratio|1.3|||||TWO_SIDED|95.0|0.8|1.98||||||Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.98|0.80|
70982118|NCT01193335|141472485|SUPERIORITY_OR_OTHER||GMT Ratio|1.4|||||TWO_SIDED|95.0|1.01|2.0||||||Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.00|1.01|
71036261|NCT01175135|141581412|OTHER||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.499||0.6214|TWO_SIDED|80.0|-0.49|0.8||Reported p-value was 1-sided.|Mixed Models Analysis|||Uncontrolled hostility/excitement Score: MMRM model with fixed effect for baseline PANSS Marder hostility/excitement score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder hostility/excitement score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.80|-0.49|0.6214
71097168|NCT00710554|141703295|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.14||||0.233|TWO_SIDED|95.0|-0.37|0.09|||ANCOVA|||The change in the punctate allodynia pain threshold force from baseline to the end of treatment was analysed using ANCOVA with the baseline value as a covariate and country and treatment group as factors.||0.09|-0.37|0.233
71036262|NCT01175135|141581412|OTHER||LS Mean Difference|-1.66|STANDARD_ERROR_OF_MEAN|0.641||0.0052|TWO_SIDED|80.0|-2.48|-0.84||Reported p-value was 1-sided.|Mixed Models Analysis|||Uncontrolled hostility/excitement Score: MMRM model with fixed effect for baseline PANSS Marder hostility/excitement score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder hostility/excitement score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||-0.84|-2.48|0.0052
70982119|NCT01193335|141472485|SUPERIORITY_OR_OTHER||GMT Ratio|1.2|||||TWO_SIDED|95.0|0.82|1.89||||||Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.89|0.82|
70982120|NCT01193335|141472485|SUPERIORITY_OR_OTHER||GMT Ratio|1.3|||||TWO_SIDED|95.0|0.8|1.99||||||Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.99|0.80|
70982121|NCT01193335|141472485|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.56|1.15||||||Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.15|0.56|
70982122|NCT01193335|141472485|SUPERIORITY_OR_OTHER||GMT Ratio|1.1|||||TWO_SIDED|95.0|0.83|1.41||||||Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.41|0.83|
70982123|NCT01193335|141472485|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.36|0.94||||||Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.94|0.36|
70982124|NCT01193335|141472485|SUPERIORITY_OR_OTHER||GMT Ratio|1.2|||||TWO_SIDED|95.0|0.88|1.68||||||Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.68|0.88|
70982125|NCT01193335|141472485|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.78|1.39||||||Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.39|0.78|
70982126|NCT01193335|141472485|SUPERIORITY_OR_OTHER||GMT Ratio|1.2|||||TWO_SIDED|95.0|0.89|1.51||||||Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.51|0.89|
70982127|NCT01193335|141472486|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.37|1.44||||||Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.44|0.37|
71036263|NCT01175135|141581412|OTHER||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.523||0.5894|TWO_SIDED|80.0|-0.55|0.79||Reported p-value was 1-sided.|Mixed Models Analysis|||Anxiety/Depression Score: MMRM model with fixed effect for baseline PANSS Marder anxiety/depression score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder anxiety/depression score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.79|-0.55|0.5894
71036264|NCT01175135|141581412|OTHER||LS Mean Difference|0.47|STANDARD_ERROR_OF_MEAN|0.526||0.8155|TWO_SIDED|80.0|-0.2|1.15||Reported p-value was 1-sided.|Mixed Models Analysis|||Anxiety/Depression Score: MMRM model with fixed effect for baseline PANSS Marder anxiety/depression score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder anxiety/depression score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||1.15|-0.20|0.8155
71036265|NCT01175135|141581412|OTHER||LS Mean Difference|-1.68|STANDARD_ERROR_OF_MEAN|0.677||0.0069|TWO_SIDED|80.0|-2.55|-0.81||Reported p-value was 1-sided.|Mixed Models Analysis|||Anxiety/Depression Score: MMRM model with fixed effect for baseline PANSS Marder anxiety/depression score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder anxiety/depression score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||-0.81|-2.55|0.0069
71036266|NCT01175135|141581413|OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.559||0.2727|TWO_SIDED|80.0|-1.06|0.38||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline PANSS derived BPRS core score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS derived BPRS core score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.38|-1.06|0.2727
71036267|NCT01175135|141581413|OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.562||0.4747|TWO_SIDED|80.0|-0.76|0.69||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline PANSS derived BPRS core score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS derived BPRS core score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.69|-0.76|0.4747
71036268|NCT01175135|141581413|OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.723||0.0031|TWO_SIDED|80.0|-2.93|-1.07||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline PANSS derived BPRS core score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS derived BPRS core score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||-1.07|-2.93|0.0031
71036269|NCT01175135|141581414|OTHER||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.196||0.3598|TWO_SIDED|80.0|-0.32|0.18||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for investigator site, treatment, visit, treatment by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||0.18|-0.32|0.3598
71036270|NCT01175135|141581414|OTHER||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.198||0.7275|TWO_SIDED|80.0|-0.13|0.37||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for investigator site, treatment, visit, treatment by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||0.37|-0.13|0.7275
71097169|NCT00710554|141703296|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.762||||0.023|TWO_SIDED|95.0|1.08|2.88|||Regression, Logistic|||The two treatment groups were compared using ordinal logistic regression and the proportional odds model. The initial model incorporated treatment and centre group as factors. The odds ratio together with its 95% CI and associated p-value are presented.||2.88|1.08|0.023
70982128|NCT01193335|141472486|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.37|1.71||||||Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.71|0.37|
70982129|NCT01193335|141472486|SUPERIORITY_OR_OTHER||GMT Ratio|1.5|||||TWO_SIDED|95.0|0.76|3.12||||||Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||3.12|0.76|
70982130|NCT01193335|141472486|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.33|1.17||||||Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.17|0.33|
70982131|NCT01193335|141472486|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.24|1.55||||||Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.55|0.24|
70982132|NCT01193335|141472486|SUPERIORITY_OR_OTHER||GMT Ratio|1.3|||||TWO_SIDED|95.0|0.97|1.77||||||Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.77|0.97|
70982133|NCT01193335|141472486|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.35|1.46||||||Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.46|0.35|
70982134|NCT01193335|141472486|SUPERIORITY_OR_OTHER||GMT Ratio|1.3|||||TWO_SIDED|95.0|1.0|1.6||||||Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.60|1.00|
70982135|NCT01193335|141472486|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.68|1.33||||||Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.33|0.68|
70982136|NCT01193335|141472486|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.82|1.31||||||Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.31|0.82|
70982137|NCT01193335|141472486|SUPERIORITY_OR_OTHER||GMT Ratio|0.5|||||TWO_SIDED|95.0|0.24|1.04||||||Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.04|0.24|
70982138|NCT01193335|141472486|SUPERIORITY_OR_OTHER||GMT Ratio|1.2|||||TWO_SIDED|95.0|0.58|2.53||||||Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.53|0.58|
70982139|NCT01193335|141472486|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.52|1.37||||||Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.37|0.52|
70982140|NCT01193335|141472487|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.45|0.97||||||Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.97|0.45|
71036271|NCT01175135|141581414|OTHER||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.255||0.0019|TWO_SIDED|80.0|-1.07|-0.42||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for investigator site, treatment, visit, treatment by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||-0.42|-1.07|0.0019
71097170|NCT00710554|141703297|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.25||||0.288|TWO_SIDED|95.0|-0.72|0.21|||ANCOVA|||The change from baseline in mean Brief Pain Inventory (short form) score was compared between treatment groups and centres using ANCOVA. The model was to include treatment and centre group as factors and baseline mean usage as a covariate.||0.21|-0.72|0.288
71097171|NCT00710554|141703298|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.01||||0.617|TWO_SIDED|95.0|-0.06|0.04|||ANCOVA|||The change from baseline in mean EuroQol-5D score was compared between treatment groups and centres using ANCOVA. The model included treatment and centre groups as factors and baseline mean usage as a covariate.||0.04|-0.06|0.617
71097172|NCT00710554|141703299|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|2.459||0.76|TWO_SIDED|95.0|-5.6|4.09|||ANCOVA|||The change from baseline in mean EuroQol-5D score was compared between treatment groups and centres using ANCOVA. The model included treatment and centre groups as factors and baseline mean usage as a covariate.||4.09|-5.60|0.76
70982141|NCT01193335|141472487|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.54|1.4||||||Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.40|0.54|
70982142|NCT01193335|141472487|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.41|1.31||||||Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.31|0.41|
70982143|NCT01193335|141472487|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.54|1.14||||||Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.14|0.54|
70982144|NCT01193335|141472487|SUPERIORITY_OR_OTHER||GMT Ratio|0.5|||||TWO_SIDED|95.0|0.34|0.87||||||Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.87|0.34|
70982145|NCT01193335|141472487|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.31|1.1||||||Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.10|0.31|
70982146|NCT01193335|141472487|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.4|1.01||||||Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.01|0.40|
71036272|NCT01175135|141581415|OTHER||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|1.478||0.5429|TWO_SIDED|80.0|-2.06|1.74||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline GAF score, investigator site, treatment, visit, treatment by visit interaction, baseline GAF score by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||1.74|-2.06|0.5429
71036273|NCT01175135|141581415|OTHER||LS Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|1.492||0.4354|TWO_SIDED|80.0|-1.68|2.16||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline GAF score, investigator site, treatment, visit, treatment by visit interaction, baseline GAF score by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||2.16|-1.68|0.4354
71036274|NCT01175135|141581415|OTHER||LS Mean Difference|2.53|STANDARD_ERROR_OF_MEAN|1.907||0.093|TWO_SIDED|80.0|0.08|4.99||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline GAF score, investigator site, treatment, visit, treatment by visit interaction, baseline GAF score by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||4.99|0.08|0.0930
71036275|NCT05283148|141581439|OTHER|Distribution was non-normal, so a Wilcoxon rank-sum test (two-sided) was used.||||||0.321||||||A p-value \< 0.05 was considered statistically significant.|Wilcoxon rank-sum test (two-sided)|||Comparison between Group A and Group B as defined above. Values are reported as median (full range) for each group, measured by DXA at the lumbar spine. Distribution was non-normal, so a Wilcoxon rank-sum test (two-sided) was used. A p-value \< 0.05 was considered statistically significant.||||0.321
70982147|NCT01193335|141472487|SUPERIORITY_OR_OTHER||GMT Ratio|0.5|||||TWO_SIDED|95.0|0.38|0.81||||||Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.81|0.38|
71036276|NCT05283148|141581440|OTHER|Welch two-sample t-test (two-sided) was used to account for unequal variances.||||||0.714||||||A p-value \< 0.05 was considered statistically significant.|Welch two sample t-test|||Comparison between Group A and Group B as defined above. Values are reported as median ± full range for each group, derived from DXA lumbar spine scans. Welch two-sample t-test (two-sided) was used to account for unequal variances. A p-value \< 0.05 was considered statistically significant.||||0.714
71036277|NCT05283148|141581441|OTHER|Distribution was non-normal, so a Wilcoxon rank-sum test (two-sided) was used.||||||0.09||||||p-value \< 0.05 was considered statistically significant.|Wilcoxon rank-sum test (two-sided)|||Comparison between Group A and Group B as defined above. Values are reported as median (full range) for each group, measured by DXA at the total hip. Distribution was non-normal, so a Wilcoxon rank-sum test (two-sided) was used. A p-value \< 0.05 was considered statistically significant.||||0.09
71036278|NCT05283148|141581442|OTHER|Welch two-sample t-test (two-sided) was used to account for unequal variances.||||||0.604||||||A p-value \< 0.05 was considered statistically significant.|Welch two sample t-test (two sided)|||Comparison between Group A and Group B as defined above. Values are reported as median ± full range for each group, derived from DXA total hip scans. Welch two-sample t-test (two-sided) was used to account for unequal variances. A p-value \< 0.05 was considered statistically significant.||||0.604
71036279|NCT05283148|141581443|OTHER|Distribution was non-normal, so a Wilcoxon rank-sum test (two-sided) was used.||||||0.013||||||A p-value \< 0.05 was considered statistically significant.|Wilcoxon rank-sum test (two-sided)|||Comparison between Group A and Group B as defined above. Values are reported as median (full range) for each group, measured by DXA at the femoral neck. Distribution was non-normal, so a Wilcoxon rank-sum test (two-sided) was used. A p-value \< 0.05 was considered statistically significant.||||0.013
71097173|NCT00710554|141703300|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.38||||0.112|TWO_SIDED|95.0|-0.85|0.09|||ANCOVA|||The model used for the analysis of the end of study value was an ANCOVA with baseline value as a covariate and treatment group and centre group as main effect. The null hypothesis was one of no difference between treatments.||0.09|-0.85|0.112
71097174|NCT00378560|141703303|SUPERIORITY_OR_OTHER||Percent Relative Risk Reduction|87.6|||||TWO_SIDED|95.0|59.2|97.6|||||Binomial probability conditional on the fixed number of events.|||97.6|59.2|
71097175|NCT00378560|141703304|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
70982148|NCT01193335|141472487|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.76|1.17||||||Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.17|0.76|
70982149|NCT01193335|141472487|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.45|0.91||||||Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.91|0.45|
70982150|NCT01193335|141472487|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.47|0.85||||||Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.85|0.47|
70982151|NCT01193335|141472487|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.74|1.15||||||Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.15|0.74|
70982152|NCT01193335|141472487|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.52|0.88||||||Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.88|0.52|
70982153|NCT01193335|141472488|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.35|2.05||||||Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.05|0.35|
70982154|NCT01193335|141472488|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.41|2.63||||||Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.63|0.41|
70982155|NCT01193335|141472488|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.22|1.53||||||Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.53|0.22|
70982156|NCT01193335|141472488|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.38|1.44||||||Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.44|0.38|
70982157|NCT01193335|141472488|SUPERIORITY_OR_OTHER||GMT Ratio|0.3|||||TWO_SIDED|95.0|0.1|0.76||||||Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.76|0.10|
70982158|NCT01193335|141472488|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.25|1.3||||||Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.30|0.25|
70982159|NCT01193335|141472488|SUPERIORITY_OR_OTHER||GMT Ratio|0.3|||||TWO_SIDED|95.0|0.11|0.65||||||Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.65|0.11|
70982160|NCT01193335|141472488|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.81|1.32||||||Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.32|0.81|
70982161|NCT01193335|141472488|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.56|1.37||||||Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.37|0.56|
70982162|NCT01193335|141472488|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.51|1.23||||||Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.23|0.51|
70982163|NCT01193335|141472488|SUPERIORITY_OR_OTHER||GMT Ratio|0.4|||||TWO_SIDED|95.0|0.17|0.86||||||Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.86|0.17|
70982164|NCT01193335|141472488|SUPERIORITY_OR_OTHER||GMT Ratio|1.1|||||TWO_SIDED|95.0|0.64|1.97||||||Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.97|0.64|
71097176|NCT00378560|141703305|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71097177|NCT00378560|141703306|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71097178|NCT00378560|141703307|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71097179|NCT03203512|141703313|SUPERIORITY||||||<|0.001||||||Treatment effect: p\<0.001; period effect : p=0.552; treatment x period interaction: p=0.622|ANOVA|||Null hypothesis is that there was no difference in change of total EV numbers detected by NTA between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on total EV numbers.||||<0.001
71097180|NCT03203512|141703314|SUPERIORITY||||||=|0.001||||||Treatment: p=0.001; period: p=0.646; treatment x period interaction: p=0.267|ANOVA|||Null hypothesis is that there was no difference in change of total PS+EV numbers detected by FCM between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on total PS+EV numbers.||||=0.001
71097181|NCT03203512|141703315|SUPERIORITY||||||=|0.002||||||Treatment: p=0.002; period: p=0.350; treatment x period interaction: p=0.572|ANOVA|||Null hypothesis is that there was no difference in change of PDEV numbers detected by FCM between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on PDEV numbers.||||=0.002
71097182|NCT03203512|141703315|SUPERIORITY|Null hypothesis is that there was no difference in change of EDEV numbers detected by FCM between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EDEV numbers.|||||<|0.001||||||Treatment: p\<0.001; period: p=0.362; treatment x period interaction: p=0.225|ANOVA|||||||<0.001
71097183|NCT03203512|141703316|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.010; treatment x period: p=0.608|ANOVA|||Null hypothesis is that there was no difference in change of EV thrombogenicity in affecting lag time for TF-dependent thrombin generation between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EV thrombogenicity.||||<0.001
71097184|NCT03203512|141703317|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.073; treatment x period: p=0.667|ANOVA|||Null hypothesis is that there was no difference in change of EV thrombogenicity in affecting TF-dependent thrombin peak concentration between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EV thrombogenicity.||||<0.001
71097185|NCT03203512|141703318|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.138; treatment x period: p=0.872|ANOVA|||Null hypothesis is that there was no difference in change of EV thrombogenicity in affecting the time to reach peak TF-dependent thrombin concentration between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EV thrombogenicity.||||<0.001
70982165|NCT01193335|141472488|SUPERIORITY_OR_OTHER||GMT Ratio|0.5|||||TWO_SIDED|95.0|0.27|0.97||||||Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.97|0.27|
71097186|NCT03203512|141703319|SUPERIORITY||||||=|0.015||||||Treatment: p=0.015; period: p=0.059; treatment x period: p=0.220|ANOVA|||Null hypothesis is that there was no difference in change of EV thrombogenicity in affecting TF-dependent velocity index between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EV thrombogenicity.||||=0.015
71097187|NCT03203512|141703320|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.118; treatment x period: p=0.802|ANOVA|||Null hypothesis is that there was no difference in change of EV thrombogenicity in affecting TF-dependent endogenous thrombin potential (ETP) between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EV thrombogenicity.||||<0.001
71097188|NCT03203512|141703321|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of platelet function in affecting LogEC50 values in response to ADP between fish oil and placebo capsules. Comparisons of this parameter after each intervention were drawn using 2-way ANOVA with the Turkey multiple comparisons test.||||>0.05
70922813|NCT04950127|141336684|SUPERIORITY||Percentage Difference|13.0||||0.043|TWO_SIDED|95.0|0.0|27.0||Adjusted for multiplicity; two-sided p-values \<0.05 were considered to be nominally significant as per SAP.|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel (CMH) stratified analysis adjusted for baseline factors: Baseline Itch Severity (Moderate: \>=4 and \<7, Severe: \>=7); Concomitant cholestatic pruritus treatment regimen (Regimen contains BABR, Regimen does not contain BABR, No defined treatment). Multiple imputation of missing Monthly itch scores was done before deriving responder definitions. Imputed datasets were analyzed using the CMH method and combined.||27.0|0.0|0.043
70922814|NCT04950127|141336685|SUPERIORITY||Percentage Difference|12.0||||0.058|TWO_SIDED|95.0|0.0|24.0||Adjusted for multiplicity; two-sided p-values \<0.05 were considered to be nominally significant as per SAP.|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel (CMH) stratified analysis adjusted for baseline factors: Baseline Itch Severity (Moderate: \>=4 and \<7, Severe: \>=7); Concomitant cholestatic pruritus treatment regimen (Regimen contains BABR, Regimen does not contain BABR, No defined treatment). Multiple imputation of missing Monthly itch scores was done before deriving responder definitions. Imputed datasets were analyzed using the CMH method and combined.||24.0|-0.0|0.058
70922815|NCT04950127|141336686|SUPERIORITY|Cognitive|Mean Difference (Net)|0.76||||0.176|TWO_SIDED|95.0|-0.34|1.86||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.||1.86|-0.34|0.176
70922816|NCT04950127|141336686|SUPERIORITY|Emotional|Mean Difference (Net)|0.27||||0.403|TWO_SIDED|95.0|-0.36|0.89||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.||0.89|-0.36|0.403
70982166|NCT01193335|141472489|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.33|2.37||||||Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.37|0.33|
70982167|NCT01193335|141472489|SUPERIORITY_OR_OTHER||GMT Ratio|1.1|||||TWO_SIDED|95.0|0.37|3.07||||||Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||3.07|0.37|
70982168|NCT01193335|141472489|SUPERIORITY_OR_OTHER||GMT Ratio|1.7|||||TWO_SIDED|95.0|0.57|5.36||||||Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||5.36|0.57|
70982169|NCT01193335|141472489|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.38|2.07||||||Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.07|0.38|
70982170|NCT01193335|141472489|SUPERIORITY_OR_OTHER||GMT Ratio|0.5|||||TWO_SIDED|95.0|0.18|1.21||||||Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.21|0.18|
70982171|NCT01193335|141472489|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.27|1.53||||||Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.53|0.27|
70982172|NCT01193335|141472489|SUPERIORITY_OR_OTHER||GMT Ratio|0.4|||||TWO_SIDED|95.0|0.17|1.15||||||Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.15|0.17|
70982173|NCT01193335|141472489|SUPERIORITY_OR_OTHER||GMT Ratio|1.1|||||TWO_SIDED|95.0|0.96|1.31||||||Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.31|0.96|
70982174|NCT01193335|141472489|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.41|1.14||||||Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.14|0.41|
70982175|NCT01193335|141472489|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.49|0.92||||||Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.92|0.49|
70982176|NCT01193335|141472489|SUPERIORITY_OR_OTHER||GMT Ratio|0.4|||||TWO_SIDED|95.0|0.16|1.03||||||Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.03|0.16|
70982177|NCT01193335|141472489|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.27|1.48||||||Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.48|0.27|
70982178|NCT01193335|141472489|SUPERIORITY_OR_OTHER||GMT Ratio|0.5|||||TWO_SIDED|95.0|0.22|0.91||||||Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.91|0.22|
70982179|NCT01193335|141472490|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.33|5.99||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.99|-6.33|
70982180|NCT01193335|141472490|SUPERIORITY_OR_OTHER||Percent Difference|-4.89|||||TWO_SIDED|95.0|-16.87|5.39||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.39|-16.87|
71036280|NCT05283148|141581444|OTHER|Welch two-sample t-test (two-sided) was used to account for unequal variances.||||||0.166||||||A p-value \< 0.05 was considered statistically significant.|Welch two sample t-test|||Comparison between Group A and Group B as defined above. Values are reported as median ± full range for each group, derived from DXA femoral neck scans. Welch two-sample t-test (two-sided) was used to account for unequal variances. A p-value \< 0.05 was considered statistically significant.||||0.166
70982181|NCT01193335|141472490|SUPERIORITY_OR_OTHER||Percent Difference|-6.85|||||TWO_SIDED|95.0|-24.28|10.67||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||10.67|-24.28|
70982182|NCT01193335|141472490|SUPERIORITY_OR_OTHER||Percent Difference|3.03|||||TWO_SIDED|95.0|-3.68|10.57||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||10.57|-3.68|
70982183|NCT01193335|141472490|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.57|5.88||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.88|-6.57|
71097189|NCT03203512|141703321|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of platelet function in affecting LogEC50 values in response to epinephrine between fish oil and placebo capsules. Comparisons of this parameter after each intervention were drawn using 2-way ANOVA with the Turkey multiple comparisons test.||||>0.05
70982184|NCT01193335|141472490|SUPERIORITY_OR_OTHER||Percent Difference|3.45|||||TWO_SIDED|95.0|-3.32|11.91||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||11.91|-3.32|
70982185|NCT01193335|141472490|SUPERIORITY_OR_OTHER||Percent Difference|1.52|||||TWO_SIDED|95.0|-6.73|9.94||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||9.94|-6.73|
70982186|NCT01193335|141472490|SUPERIORITY_OR_OTHER||Perecent Difference|-10.82|||||TWO_SIDED|95.0|-25.51|4.34||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||4.34|-25.51|
70982187|NCT01193335|141472490|SUPERIORITY_OR_OTHER||Percent Difference|4.65|||||TWO_SIDED|95.0|0.04|11.48||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||11.48|0.04|
70982188|NCT01193335|141472490|SUPERIORITY_OR_OTHER||Percent Difference|-16.06|||||TWO_SIDED|95.0|-29.15|-2.6||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-2.60|-29.15|
70982189|NCT01193335|141472490|SUPERIORITY_OR_OTHER||Percent Difference|2.27|||||TWO_SIDED|95.0|-1.96|7.97||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||7.97|-1.96|
70982190|NCT01193335|141472490|SUPERIORITY_OR_OTHER||Percent Difference|-2.15|||||TWO_SIDED|95.0|-7.55|2.1||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||2.10|-7.55|
70982191|NCT01193335|141472490|SUPERIORITY_OR_OTHER||Percent Difference|-1.09|||||TWO_SIDED|95.0|-5.96|3.18||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||3.18|-5.96|
70982192|NCT01193335|141472491|SUPERIORITY_OR_OTHER||Percent Difference|-9.08|||||TWO_SIDED|95.0|-25.11|7.49||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||7.49|-25.11|
70982193|NCT01193335|141472491|SUPERIORITY_OR_OTHER||Percent Difference|-5.39|||||TWO_SIDED|95.0|-21.03|10.4||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||10.40|-21.03|
70982194|NCT01193335|141472491|SUPERIORITY_OR_OTHER||Percent Difference|6.53|||||TWO_SIDED|95.0|-7.16|21.16||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||21.16|-7.16|
70982195|NCT01193335|141472491|SUPERIORITY_OR_OTHER||Percent Difference|-7.88|||||TWO_SIDED|95.0|-20.28|3.35||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||3.35|-20.28|
70982196|NCT01193335|141472491|SUPERIORITY_OR_OTHER||Percent Difference|-10.73|||||TWO_SIDED|95.0|-29.01|8.11||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||8.11|-29.01|
70982197|NCT01193335|141472491|SUPERIORITY_OR_OTHER||Percent Difference|7.11|||||TWO_SIDED|95.0|-1.52|17.65||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||17.65|-1.52|
70982198|NCT01193335|141472491|SUPERIORITY_OR_OTHER||Percent Difference|-13.37|||||TWO_SIDED|95.0|-29.57|3.31||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||3.31|-29.57|
71036281|NCT05283148|141581445|OTHER|Welch two-sample t-test (two-sided) was used to account for unequal variances.||||||0.23||||||A p-value \< 0.05 was considered statistically significant.|Welch two sample t-test (two sided)|||Comparison between Group A and Group B as defined above. Values are reported as median (interquartile range) for each group, based on the ASCQ-Me Pain Impact instrument (lower scores indicate worse pain impact). Welch two-sample t-test (two-sided) was used to account for unequal variances. A p-value \< 0.05 was considered statistically significant.||||0.23
71036282|NCT00095784|141581454|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Mixed Models Analysis|5 degrees of freedom test over six time points: day 1 (pre-treatment) and days 5, 12, 43, 47, and 54 post treatment.||Mixed effects regression analysis of change over time in CD34+ cell levels. Analysis performed on log scale.||||<0.0001
70982199|NCT01193335|141472491|SUPERIORITY_OR_OTHER||Percent Difference|8.09|||||TWO_SIDED|95.0|-0.52|17.81||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||17.81|-0.52|
70982200|NCT01193335|141472491|SUPERIORITY_OR_OTHER||Percent Difference|-7.38|||||TWO_SIDED|95.0|-22.86|8.29||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||8.29|-22.86|
70982201|NCT01193335|141472491|SUPERIORITY_OR_OTHER||Percent Difference|0.51|||||TWO_SIDED|95.0|-8.82|10.08||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||10.08|-8.82|
70982202|NCT01193335|141472491|SUPERIORITY_OR_OTHER||Percent Difference|-20.19|||||TWO_SIDED|95.0|-35.45|-3.95||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-3.95|-35.45|
70982203|NCT01193335|141472491|SUPERIORITY_OR_OTHER||Percent Difference|5.25|||||TWO_SIDED|95.0|-8.5|19.06||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||19.06|-8.50|
70982204|NCT01193335|141472491|SUPERIORITY_OR_OTHER||Percent Difference|-3.14|||||TWO_SIDED|95.0|-17.51|11.13||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||11.13|-17.51|
70982205|NCT01193335|141472492|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-5.59|5.89||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.89|-5.59|
71036283|NCT00095784|141581460|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Mixed Models Analysis|5 degrees of freedom test over six time points: day 1 (pre-treatment) and days 5, 12, 43, 47, and 54 post treatment.||Mixed effects regression analysis of change over time in CXCR4 levels. Analysis performed on log scale.||||0.29
70982206|NCT01193335|141472492|SUPERIORITY_OR_OTHER||Percent Difference|0.08|||||TWO_SIDED|95.0|-6.81|7.37||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||7.37|-6.81|
70982207|NCT01193335|141472492|SUPERIORITY_OR_OTHER||Percent Difference|-1.55|||||TWO_SIDED|95.0|-10.87|7.44||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||7.44|-10.87|
70982208|NCT01193335|141472492|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-5.94|5.94||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.94|-5.94|
71036284|NCT00095784|141581466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99|||||||Mixed Models Analysis|5 degrees of freedom test over six time points: day 1 (pre-treatment) and days 5, 12, 43, 47, and 54 post treatment.||Mixed effects regression analysis of change over time in hemoglobin F levels.||||0.99
71036285|NCT03676634|141581467|OTHER||single proportion|0.844|||||TWO_SIDED|95.0|0.672|0.947|||||Values listed in table are for Type A. Estimated Value for the Estimation Parameter for type B = 0.875. Lower limit = 0.710, upper limit = 0.965|Consider increase from baseline to post-dose values. Parameter is proportion achieving desired increase (≥ 3x or 4x increase in Type A and Type B NAC).|Proportion of participants achieving ≥ 3x or 4x increase in NAC values was calculated for both Type A and Type B. Primary endpoint was achieved if both Type A and Type B had proportion ≥50%.|.947|.672|
71036286|NCT02052895|141581470|SUPERIORITY_OR_OTHER||Difference of ROC-AUC|0.0317||||0.3924|TWO_SIDED|95.0|-0.0409|0.1043|||Regression, Logistic|||||0.1043|-0.0409|0.3924
71036287|NCT00540423|141581477|SUPERIORITY_OR_OTHER||Risk Difference (RD)|60.0||||||95.0|35.21|84.79|||||The units of risk difference is percentage.|||84.79|35.21|
71036288|NCT00540423|141581479|SUPERIORITY_OR_OTHER||Percentage of 75% responders|43.5||||||95.0|23.19|65.51|||||Confidence interval of the percentage of participants for whom at least 75% of their assessments during the course of 26 weeks of SB-494115-GR treatment met the definition of responders.|||65.51|23.19|
71036289|NCT03131895|141581501|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90 percent (%) confidence intervals (CIs) on the original scale.|Least square (LS) mean ratio|1.0436||||0.5535|TWO_SIDED|90.0|0.9453|1.1521|||ANOVA|||||1.1521|0.9453|0.5535
71036290|NCT03131895|141581501|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs on the original scale.|LS mean ratio|1.0185||||0.892|TWO_SIDED|90.0|0.9334|1.1113|||ANOVA|||||1.1113|0.9334|0.8920
71036291|NCT03131895|141581502|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs on the original scale.|LS mean ratio|1.039||||0.3209|TWO_SIDED|90.0|0.9792|1.1024|||ANOVA|||||1.1024|0.9792|0.3209
71036292|NCT03131895|141581502|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs on the original scale.|LS mean ratio|1.0353||||0.3896|TWO_SIDED|90.0|0.9719|1.1029|||ANOVA|||||1.1029|0.9719|0.3896
71036293|NCT03131895|141581503|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs on the original scale.|LS mean ratio|1.0335||||0.4163|TWO_SIDED|90.0|0.9733|1.0975|||ANOVA|||||1.0975|0.9733|0.4163
71036294|NCT03131895|141581503|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs on the original scale.|LS mean ratio|1.0031||||0.9778|TWO_SIDED|90.0|0.9458|1.0638|||ANOVA|||||1.0638|0.9458|0.9778
71036295|NCT05143047|141581534|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71036296|NCT05143047|141581535|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
71036297|NCT05143047|141581536|SUPERIORITY|||||||0.42|||||||Fisher Exact|||||||0.42
71036298|NCT05143047|141581537|SUPERIORITY|||||||0.17|||||||Fisher Exact|||||||0.17
71036299|NCT05143047|141581538|SUPERIORITY|||||||0.03|||||||Fisher Exact|||||||0.03
71036300|NCT05143047|141581539|SUPERIORITY|||||||0.42|||||||Fisher Exact|||||||0.42
71036301|NCT05143047|141581540|SUPERIORITY|||||||0.04|||||||Fisher Exact|||||||0.04
71036302|NCT05143047|141581541|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71036303|NCT05143047|141581542|SUPERIORITY|||||||0.22|||||||Fisher Exact|||||||0.22
71036304|NCT03214588|141581551|SUPERIORITY||Least Squares Mean Difference|-0.00054|STANDARD_ERROR_OF_MEAN|0.000746|>|0.999|TWO_SIDED|90.0|-0.00179|0.0007||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||0.00070|-0.00179|>0.999
71097190|NCT03203512|141703321|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of platelet function in affecting LogEC50 values in response to TRAP-6 between fish oil and placebo capsules. Comparisons of this parameter after each intervention were drawn using 2-way ANOVA with the Turkey multiple comparisons test.||||>0.05
70982209|NCT01193335|141472492|SUPERIORITY_OR_OTHER||Percent Difference|-1.61|||||TWO_SIDED|95.0|-8.66|4.25||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||4.25|-8.66|
70982210|NCT01193335|141472492|SUPERIORITY_OR_OTHER||Percent Difference|-6.64|||||TWO_SIDED|95.0|-17.93|3.56||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||3.56|-17.93|
70982211|NCT01193335|141472492|SUPERIORITY_OR_OTHER||Percent Difference|0.05|||||TWO_SIDED|95.0|-6.74|7.04||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||7.04|-6.74|
70982212|NCT01193335|141472492|SUPERIORITY_OR_OTHER||Percent Difference|-6.48|||||TWO_SIDED|95.0|-16.37|2.75||||||Serotype 1: CI Parameter was percent difference between the groups. Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||2.75|-16.37|
70982213|NCT01193335|141472492|SUPERIORITY_OR_OTHER||Percent Difference|1.27|||||TWO_SIDED|95.0|-3.37|6.85||||||Serotype 3: CI Parameter was percent difference between the groups. Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||6.85|-3.37|
70982214|NCT01193335|141472492|SUPERIORITY_OR_OTHER||Percent Difference|-1.34|||||TWO_SIDED|95.0|-8.36|5.14||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.14|-8.36|
70982215|NCT01193335|141472492|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-4.73|5.04||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.04|-4.73|
70982216|NCT01193335|141472492|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-4.48|4.55||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||4.55|-4.48|
70982217|NCT01193335|141472492|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-4.48|4.55||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||4.55|-4.48|
70982218|NCT01193335|141472493|SUPERIORITY_OR_OTHER||Percent Difference|-7.5|||||TWO_SIDED|95.0|-24.5|9.9||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||9.9|-24.5|
70982219|NCT01193335|141472493|SUPERIORITY_OR_OTHER||Percent Difference|-5.9|||||TWO_SIDED|95.0|-23.6|11.8||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||11.8|-23.6|
70982220|NCT01193335|141472493|SUPERIORITY_OR_OTHER||Percent Difference|-10.7|||||TWO_SIDED|95.0|-27.6|6.0||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||6.0|-27.6|
70982221|NCT01193335|141472493|SUPERIORITY_OR_OTHER||Percent Difference|-4.3|||||TWO_SIDED|95.0|-17.0|8.4||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||8.4|-17.0|
70982222|NCT01193335|141472493|SUPERIORITY_OR_OTHER||Percent Difference|-23.0|||||TWO_SIDED|95.0|-40.0|-4.9||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-4.9|-40.0|
70982223|NCT01193335|141472493|SUPERIORITY_OR_OTHER||Percent Difference|-11.9|||||TWO_SIDED|95.0|-27.4|3.4||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||3.4|-27.4|
70982224|NCT01193335|141472493|SUPERIORITY_OR_OTHER||Percent Difference|-28.2|||||TWO_SIDED|95.0|-43.9|-11.0||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-11.0|-43.9|
70982225|NCT01193335|141472493|SUPERIORITY_OR_OTHER||Percent Difference|-0.3|||||TWO_SIDED|95.0|-10.9|10.3||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||10.3|-10.9|
70982226|NCT01193335|141472493|SUPERIORITY_OR_OTHER||Percent Difference|-1.2|||||TWO_SIDED|95.0|-17.5|15.1||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||15.1|-17.5|
70982227|NCT01193335|141472493|SUPERIORITY_OR_OTHER||Percent Difference|-10.6|||||TWO_SIDED|95.0|-25.3|4.5||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||4.5|-25.3|
70982228|NCT01193335|141472493|SUPERIORITY_OR_OTHER||Percent Difference|-18.6|||||TWO_SIDED|95.0|-33.3|-3.0||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-3.0|-33.3|
70982229|NCT01193335|141472493|SUPERIORITY_OR_OTHER||Percent Difference|2.8|||||TWO_SIDED|95.0|-7.1|13.1||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||13.1|-7.1|
70982230|NCT01193335|141472493|SUPERIORITY_OR_OTHER||Percent Difference|-18.5|||||TWO_SIDED|95.0|-33.7|-2.8||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-2.8|-33.7|
71097191|NCT03203512|141703321|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of platelet function in affecting LogEC50 values in response to U46619 between fish oil and placebo capsules. Comparisons of this parameter after each intervention were drawn using 2-way ANOVA with the Turkey multiple comparisons test.||||>0.05
70982231|NCT01193335|141472494|SUPERIORITY_OR_OTHER||Percent Difference|-7.9|||||TWO_SIDED|95.0|-25.2|9.9||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||9.9|-25.2|
70982232|NCT01193335|141472494|SUPERIORITY_OR_OTHER||Percent Difference|0.3|||||TWO_SIDED|95.0|-18.5|19.0||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||19.0|-18.5|
70982233|NCT01193335|141472494|SUPERIORITY_OR_OTHER||Percent Difference|7.3|||||TWO_SIDED|95.0|-12.0|26.2||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||26.2|-12.0|
70982234|NCT01193335|141472494|SUPERIORITY_OR_OTHER||Percent Difference|-2.8|||||TWO_SIDED|95.0|-19.1|13.3||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||13.3|-19.1|
70982235|NCT01193335|141472494|SUPERIORITY_OR_OTHER||Percent Difference|-17.9|||||TWO_SIDED|95.0|-34.6|-0.3||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-0.3|-34.6|
70982236|NCT01193335|141472494|SUPERIORITY_OR_OTHER||Percent Difference|-4.3|||||TWO_SIDED|95.0|-20.6|12.1||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||12.1|-20.6|
70982237|NCT01193335|141472494|SUPERIORITY_OR_OTHER||Percent Difference|-21.1|||||TWO_SIDED|95.0|-37.8|-3.2||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-3.2|-37.8|
70982238|NCT01193335|141472494|SUPERIORITY_OR_OTHER||Percent Difference|5.6|||||TWO_SIDED|95.0|-2.7|15.2||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||15.2|-2.7|
70982239|NCT01193335|141472494|SUPERIORITY_OR_OTHER||Percent Difference|-5.1|||||TWO_SIDED|95.0|-22.0|12.0||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||12.0|-22.0|
70982240|NCT01193335|141472494|SUPERIORITY_OR_OTHER||Percent Difference|-14.4|||||TWO_SIDED|95.0|-26.7|-2.4||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-2.4|-26.7|
70982241|NCT01193335|141472494|SUPERIORITY_OR_OTHER||Percent Difference|-20.4|||||TWO_SIDED|95.0|-36.8|-3.0||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-3.0|-36.8|
70982242|NCT01193335|141472494|SUPERIORITY_OR_OTHER||Percent Difference|-11.3|||||TWO_SIDED|95.0|-26.4|4.1||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||4.1|-26.4|
70982243|NCT01193335|141472494|SUPERIORITY_OR_OTHER||Percent difference|-21.6|||||TWO_SIDED|95.0|-37.7|-4.6||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-4.6|-37.7|
70982244|NCT01733329|141472495|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Fisher Exact|||||||<0.01
70982245|NCT01733329|141472496|SUPERIORITY_OR_OTHER|||||||0.026|||||||Fisher Exact|||||||0.026
70982246|NCT01733329|141472497|SUPERIORITY_OR_OTHER|||||||0.058|||||||Fisher Exact|||||||0.058
70982247|NCT01733329|141472498|SUPERIORITY_OR_OTHER|||||||0.007|||||||Kruskal-Wallis|||||||0.007
70982248|NCT01078753|141472499|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.813||||0.009|TWO_SIDED|95.0|0.462|3.163||Desmopressin was considered to be superior to Placebo if the p-value for the comparison was \< 0.05 and the reduction from Baseline in number of wet nights was larger in the FE992026 group than in the Placebo group.|ANCOVA|Factors in the analysis were Gender (male, female), age (6≤x≤9, 10≤x≤15), number of wet nights at Baseline (10≤x≤13, x=14), and treatment group.||||3.163|0.462|0.009
70982249|NCT01078753|141472500|SUPERIORITY_OR_OTHER||Least Squares mean Difference|1.629||||0.018|TWO_SIDED|95.0|0.287|2.972|||ANCOVA|Factors in the analysis were Gender (male, female), age (6≤x≤9, 10≤x≤15), number of wet nights at Baseline (10≤x≤13, x=14), and treatment group.||||2.972|0.287|0.018
70982250|NCT01078753|141472501|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.183||||0.752|TWO_SIDED|95.0|-0.968|1.335|||ANCOVA|Factors in the analysis included Gender (male, female), age (6≤x≤9, 10≤x≤15), number of wet nights at Baseline (10≤x≤13, x=14), and treatment group.||||1.335|-0.968|0.752
70982251|NCT03772327|141472551|SUPERIORITY||Mean Difference (Net)|0.333||||0.07|TWO_SIDED|95.0|-0.028|0.694|||t-test, 2 sided|A ratio of Week 12 to baseline TFV-DP levels was used rather than a raw difference as a ratio was normally distributed.|The mean difference is mean ratio (Week 12 TFV-DP level over the Week 0 TFV-DP level) in the Routine counseling + AdhereTech bottle arm less the mean ratio in the Routine counseling arm.|The power calculation was based on a null hypothesis of no difference in mean tenofovir-diphosphate (TFV-DP) concentrations between baseline versus week 12. Expected baseline mean (SD): 900 (404) fmol/punch. 12 week mean (SD): 1332 (597) fmol/punch in the AdhereTech bottle arm vs. 900 (404) fmol/punch in control arm. Type 1 error = 0.05, power = 80%, a sample size of 32 per arm (64 total) based on a two-sided t-test with equal variance.||0.694|-0.028|0.070
70982252|NCT03772327|141472552|EQUIVALENCE|Equivalence defined if a two-sided 2 sample proportion test accepts the null hypothesis with p \> 0.05.|Difference in proportions|0.045||||0.89|TWO_SIDED|95.0|-0.179|0.27|||Chi-squared, Corrected|degrees of freedom = 1|This is the proportion of those completing a week 12 visit less those completing a week 0 visit.|The null hypothesis is that the proportion of randomized participants that complete a week 12 visit is not lower in the AdhereTech bottle arm.||0.270|-0.179|0.89
70982253|NCT03772327|141472553|SUPERIORITY||Median Difference (Net)|-0.07||||0.328|TWO_SIDED||||||Kruskal-Wallis|Log transformation of viral load|Difference of log viral load at Week 12 less the log viral load at baseline|Null hypothesis: Mean HIV viral load is not significantly different in the AdhereTech bottle group compared to the routine counseling only group.||||0.328
70982254|NCT03772327|141472554|SUPERIORITY||Odds Ratio (OR)|0.395||||0.294|TWO_SIDED|95.0|0.058|2.044|||Fisher Exact||Odds ratio for change from HIV RNA ≥ 20 copies/mL at baseline to HIV RNA \< 20 copies/mL at week 12 due to the intervention (AdhereTech bottle).|Null hypothesis: There is no difference in proportion of participants that go from HIV RNA ≥ 20 copies/mL to HIV RNA \< 20 copies/mL between baseline to Week 12 in the AdhereTech bottle group compared the routine counseling group.||2.044|0.058|0.294
70982255|NCT03772327|141472556|SUPERIORITY||Difference in proportions|0.019||||1|TWO_SIDED|95.0|-0.237|0.276|||Chi-squared, Corrected|||Null hypothesis: Adherence in the AdhereTech bottle arm is not better than the control arm at Week 12.||0.276|-0.237|1
71036305|NCT03214588|141581551|SUPERIORITY||Least Squares Mean Difference|-0.00069|STANDARD_ERROR_OF_MEAN|0.000616|>|0.999|TWO_SIDED|90.0|-0.00172|0.00033||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||0.00033|-0.00172|>0.999
71036306|NCT03214588|141581552|SUPERIORITY||Least Squares Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.782||0.135|TWO_SIDED|90.0|-2.18|0.44||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||0.44|-2.18|0.135
71036307|NCT03214588|141581552|SUPERIORITY||Least Squares Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.64||0.818|TWO_SIDED|90.0|-0.48|1.66||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||1.66|-0.48|0.818
71036308|NCT03214588|141581552|SUPERIORITY||Least Squares Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.77||0.591|TWO_SIDED|90.0|-1.11|1.47||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||1.47|-1.11|0.591
71036309|NCT03214588|141581552|SUPERIORITY||Least Squares Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.643||0.713|TWO_SIDED|90.0|-0.71|1.44||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||1.44|-0.71|0.713
71036310|NCT03214588|141581552|SUPERIORITY||Least Squares Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.822||0.616|TWO_SIDED|90.0|-1.13|1.62||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||1.62|-1.13|0.616
71036311|NCT03214588|141581552|SUPERIORITY||Least Squares Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.679||0.708|TWO_SIDED|90.0|-0.76|1.51||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||1.51|-0.76|0.708
71036312|NCT03214588|141581553|SUPERIORITY||Least Squares Mean Difference|-0.00039|STANDARD_ERROR_OF_MEAN|0.000604||0.741|TWO_SIDED|90.0|-0.0014|0.00062||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||0.00062|-0.00140|0.741
71036313|NCT03214588|141581553|SUPERIORITY||Least Squares Mean Difference|-0.00093|STANDARD_ERROR_OF_MEAN|0.000505||0.964|TWO_SIDED|90.0|-0.00177|-0.00008||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||-0.00008|-0.00177|0.964
71036314|NCT03214588|141581553|SUPERIORITY||Least Squares Mean Difference|-0.00014|STANDARD_ERROR_OF_MEAN|0.000772||0.573|TWO_SIDED|90.0|-0.00143|0.00115||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||0.00115|-0.00143|0.573
70982256|NCT03133767|141472609|SUPERIORITY|||||||0.608|||||||Wilcoxon (Mann-Whitney)|||||||0.608
71036315|NCT03214588|141581553|SUPERIORITY||Least Squares Mean Difference|-0.00044|STANDARD_ERROR_OF_MEAN|0.000646||0.749|TWO_SIDED|90.0|-0.00152|0.00064||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||0.00064|-0.00152|0.749
70982257|NCT03133767|141472610|SUPERIORITY|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||||||0.027
70982258|NCT03133767|141472611|SUPERIORITY|||||||0.202|||||||Chi-squared|||||||0.202
70982259|NCT03133767|141472612|SUPERIORITY|||||||0.361|||||||Chi-squared|||||||0.361
71036316|NCT03214588|141581554|SUPERIORITY||Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.154||0.571|TWO_SIDED|90.0|-0.23|0.29||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Cutting-Handling Utensils||0.29|-0.23|0.571
71036317|NCT03214588|141581554|SUPERIORITY||Least Squares Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.126||0.963|TWO_SIDED|90.0|0.02|0.44||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Cutting-Handling Utensils||0.44|0.02|0.963
71036318|NCT03214588|141581554|SUPERIORITY||Least Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.165||0.515|TWO_SIDED|90.0|-0.27|0.28||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Cutting-Handling Utensils||0.28|-0.27|0.515
71097192|NCT03203512|141703322|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of platelet function in affecting LogEC50 values in response to CRP-XL between fish oil and placebo capsules. Comparisons of this parameter after each intervention were drawn using 2-way ANOVA with the Turkey multiple comparisons test.||||>0.05
71097193|NCT03203512|141703323|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of pro-thrombotic activity of PDEVs in affecting endpoint for ex vivo thrombus formation between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on the pro-thrombotic activity of PDEVs.||||>0.05
71097194|NCT03203512|141703323|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of pro-thrombotic activity of PDEVs in affectingamximum for ex vivo thrombus formation between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on the pro-thrombotic activity of PDEVs.||||>0.05
71097195|NCT03203512|141703324|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of pro-thrombotic activity of PDEVs in affecting area under curve for ex vivo thrombus formation between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on the pro-thrombotic activity of PDEVs.||||>0.05
71097196|NCT03203512|141703325|SUPERIORITY||||||<|0.001||||||Treatment: \<0.001; period: p=0.978; treatment x period interaction: p=0.140|ANOVA|||Null hypothesis is that there was no difference in change of EPA in circulating EV total lipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EPA in circulating EV total lipids.||||<0.001
71097197|NCT03203512|141703325|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.699; treatment x period interaction: p=0.114|ANOVA|||Null hypothesis is that there was no difference in change of DHA in circulating EV total lipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on DHA in circulating EV total lipids.||||<0.001
71097198|NCT03203512|141703325|SUPERIORITY||||||=|0.011||||||Treatment: p=0.011; period: p=0.381; treatment x period interaction: p=0.762|ANOVA|||Null hypothesis is that there was no difference in change of oleic acid in circulating EV total lipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on oleic acid in circulating EV total lipids.||||=0.011
71097199|NCT03203512|141703325|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.512; treatment x period interaction: p=0.812|ANOVA|||Null hypothesis is that there was no difference in change of AA in circulating EV total lipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on AA in circulating EV total lipids.||||<0.001
71097200|NCT03203512|141703325|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.160; treatment x period interaction: p=0.132|ANOVA|||Null hypothesis is that there was no difference in change of total n-3 PUFA in circulating EV total lipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on total n-3 PUFA in circulating EV total lipids.||||<0.001
71097201|NCT03203512|141703325|SUPERIORITY||||||=|0.013||||||Treatment: p=0.013; period: p=0.500; treatment x period interaction: p=0.522|ANOVA|||Null hypothesis is that there was no difference in change of total MUFA in circulating EV total lipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on total MUFA in circulating EV total lipids.||||=0.013
71097202|NCT03203512|141703326|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.169; treatment x period interaction: p=0.629|ANOVA|||Null hypothesis is that there was no difference in change of EPA in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EPA in plasma total phospholipids.||||<0.001
71097203|NCT03203512|141703326|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.262; treatment x period interaction: p=0.150|ANOVA|||Null hypothesis is that there was no difference in change of DHA in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on DHA in plasma total phospholipids.||||<0.001
71097204|NCT03203512|141703326|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.302; treatment x period interaction: p=0.385|ANOVA|||Null hypothesis is that there was no difference in change of DPA in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on DPA in plasma total phospholipids.||||<0.001
71097205|NCT03203512|141703326|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.793; treatment x period interaction: p=0.522|ANOVA|||Null hypothesis is that there was no difference in change of linoleic acid in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on linoleic acid in plasma total phospholipids.||||<0.001
71097206|NCT03203512|141703326|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.956; treatment x period interaction: p=0.238|ANOVA|||Null hypothesis is that there was no difference in change of dihomo-γ-linolenic acid (DGLA) in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on DGLA in plasma total phospholipids.||||<0.001
71097207|NCT03203512|141703326|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.457; treatment x period interaction: p=0.613|ANOVA|||Null hypothesis is that there was no difference in change of AA in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on AA in plasma total phospholipids.||||<0.001
70982260|NCT03133767|141472613|SUPERIORITY|||||||0.509|||||||Chi-squared|||||||0.509
70982261|NCT04233424|141472614|SUPERIORITY||Risk Ratio (RR)|-2.8||||0.152|TWO_SIDED|95.0|-6.7|1.0|||Cochran-Mantel-Haenszel|||||1.0|-6.7|0.152
70982262|NCT04233424|141472615|SUPERIORITY||Risk Ratio (RR)|-0.8||||0.6219|TWO_SIDED|95.0|-3.9|2.3|||Cochran-Mantel-Haenszel|||||2.3|-3.9|0.6219
70982263|NCT04233424|141472616|SUPERIORITY||Risk Ratio (RR)|-0.8||||0.4373|TWO_SIDED|95.0|-2.8|1.2|||Kaplan-Meier Analysis|||||1.2|-2.8|0.4373
70982264|NCT03664726|141472619|SUPERIORITY|||||||0.0034||||||Comparison of differences by group|ANOVA|||||||0.0034
70982265|NCT03664726|141472620|SUPERIORITY|||||||0.76|||||||ANOVA|||||||0.76
71036319|NCT03214588|141581554|SUPERIORITY||Least Squares Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.138||0.986|TWO_SIDED|90.0|0.08|0.54||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Cutting-Handling Utensils||0.54|0.08|0.986
70982266|NCT03664726|141472621|SUPERIORITY|||||||0.77|||||||ANOVA|||||||0.77
70982267|NCT03119649|141472624|SUPERIORITY||Difference in LS Means|-3.3|STANDARD_ERROR_OF_MEAN|4.15||0.4291|TWO_SIDED|95.0|-11.6|5.0||P-value obtained from the Mixed Effects Model for Repeated Measures (MMRM) analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 50 mg QD vs. Pooled Placebo||5.0|-11.6|0.4291
70982268|NCT03119649|141472624|SUPERIORITY||Difference in LS Means|-4.1|STANDARD_ERROR_OF_MEAN|4.32||0.3477|TWO_SIDED|95.0|-12.8|4.6||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 100 mg QD vs. Pooled Placebo||4.6|-12.8|0.3477
70982269|NCT03119649|141472624|SUPERIORITY||Difference in LS Means|-15.8|STANDARD_ERROR_OF_MEAN|3.72|<|0.0001|TWO_SIDED|95.0|-23.2|-8.3||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 200 mg QD vs. Pooled Placebo||-8.3|-23.2|<0.0001
70982270|NCT03119649|141472624|SUPERIORITY||Difference in LS Means|-6.3|STANDARD_ERROR_OF_MEAN|3.76||0.0995|TWO_SIDED|95.0|-13.9|1.2||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 400 mg QD vs. Pooled Placebo||1.2|-13.9|0.0995
70982271|NCT03119649|141472625|SUPERIORITY||Difference in LS Means|1.1|STANDARD_ERROR_OF_MEAN|2.11||0.594|TWO_SIDED|95.0|-3.1|5.4||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 50 mg QD vs. Pooled Placebo||5.4|-3.1|0.5940
70982272|NCT03119649|141472625|SUPERIORITY||Difference in LS Means|0.6|STANDARD_ERROR_OF_MEAN|2.06||0.7553|TWO_SIDED|95.0|-3.5|4.8||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 100 mg QD vs. Pooled Placebo||4.8|-3.5|0.7553
70982273|NCT03119649|141472625|SUPERIORITY||Difference in LS Means|1.0|STANDARD_ERROR_OF_MEAN|1.94||0.5958|TWO_SIDED|95.0|-2.9|4.9||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 200 mg QD vs. Pooled Placebo||4.9|-2.9|0.5958
70982274|NCT03119649|141472625|SUPERIORITY||Difference in LS Means|2.3|STANDARD_ERROR_OF_MEAN|1.94||0.2403|TWO_SIDED|95.0|-1.6|6.2||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 400 mg QD vs. Pooled Placebo||6.2|-1.6|0.2403
70982275|NCT03119649|141472626|SUPERIORITY||Difference in LS Means|2.7|STANDARD_ERROR_OF_MEAN|4.81||0.5749|TWO_SIDED|95.0|-6.9|12.4||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 50 mg QD vs. Pooled Placebo||12.4|-6.9|0.5749
71097208|NCT03203512|141703326|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.134; treatment x period interaction: p=0.260|ANOVA|||Null hypothesis is that there was no difference in change of total n-3 PUFA in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on total n-3 PUFA in plasma total phospholipids.||||<0.001
70982276|NCT03119649|141472626|SUPERIORITY||Difference in LS Means|1.6|STANDARD_ERROR_OF_MEAN|4.83||0.7381|TWO_SIDED|95.0|-8.1|11.3||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 100 mg QD vs. Pooled Placebo||11.3|-8.1|0.7381
70982277|NCT03119649|141472626|SUPERIORITY||Difference in LS Means|6.8|STANDARD_ERROR_OF_MEAN|4.43||0.1282|TWO_SIDED|95.0|-2.0|15.7||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 200 mg QD vs. Pooled Placebo||15.7|-2.0|0.1282
70982278|NCT03119649|141472626|SUPERIORITY||Difference in LS Means|1.6|STANDARD_ERROR_OF_MEAN|4.43||0.7212|TWO_SIDED|95.0|-7.3|10.5||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 400 mg QD vs. Pooled Placebo||10.5|-7.3|0.7212
70982279|NCT02333227|141472631|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis||||We employed generalized linear mixed methods (GLMM) with binomial distribution to examine the association between study primary outcomes of baby's birth weight (\<2500) and gestational age at delivery (\<37 weeks including up to 36 and 6/7 weeks) and assignment to the study intervention group. To account for clustering of outcomes by cluster (sites), we used random slope/random intercept GLMM models with a cluster as a random effect (level 2) and treatment as a fixed effect (level 1), since random effect modeling is an individual-level analyses that accounts for within-cluster dependence by maximum likelihood estimation. A separate model was fit to each study outcome and corresponding relative risk with 95% confidence intervals (CI) estimated. Full information maximum likelihood estimation (FIML) allows for analyses to be performed with the full sample, under conditions of Missing Completely at Random (MCAR) and Missing at Random (MAR), and with missing data rates up to 50%.|||<0.05
70982280|NCT02333227|141472632|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Co-primary outcomes|We employed generalized linear mixed methods (GLMM) with binomial distribution to examine the association between study primary outcomes of baby's birth weight (\<2500) and gestational age at delivery (\<37 weeks including up to 36 and 6/7 weeks) and assignment to the study intervention group. To account for clustering of outcomes by cluster (sites), we used random slope/random intercept GLMM models with a cluster as a random effect (level 2) and treatment as a fixed effect (level 1), since random effect modeling is an individual-level analyses that accounts for within-cluster dependence by maximum likelihood estimation. A separate model was fit to each study outcome and corresponding relative risk with 95% confidence intervals (CI) estimated. Full information maximum likelihood estimation (FIML) allows for analyses to be performed with the full sample, under conditions of Missing Completely at Random (MCAR) and Missing at Random (MAR), and with missing data rates up to 50%.|||<0.05
70982281|NCT02333227|141472633|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
70982282|NCT02333227|141472634|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis||||Specifically, the composite of periodontal disease was also created; this composite was positive if any of the following were detected: gingival bleeding, pockets of 4 mm or greater, or loss of attachment of 4 mm or greater. A scaled periodontal disease score was also created which was the sum of scores for gingival bleeding (+1 if bleeding was present, per tooth), gingival pockets (+1 for pockets of 4-5 mm and +2 for 6 mm or deeper, per tooth), and loss of attachment (+1 for 4-5 mm loss, +2 for 6-8 mm, +3 for 9-11 mm, and +4 for 12 mm or more, per tooth with values recorded for index teeth) divided by the number of teeth present.|||<0.05
70982283|NCT02333227|141472635|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
70982284|NCT01254344|141472636|NON_INFERIORITY_OR_EQUIVALENCE|"Assuming a 70% rate (i.e., proportion of participants with success of prophylaxis) for both groups and a significance level of 0.025, at least 200 evaluable participants per group were needed to have 90% probability that the lower limit of the 95% (two-sided) confidence interval for the difference in the response rates between the 2 groups was greater than -15 percentage points."|Difference in percentage of prophylaxis|0.1|||||TWO_SIDED|95.0|-5.2|5.5|||Miettinen and Nurminen|||||5.5|-5.2|
71097209|NCT03203512|141703326|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.917; treatment x period interaction: p=0.603|ANOVA|||Null hypothesis is that there was no difference in change of total n-6 PUFA in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on total n-6 PUFA in plasma total phospholipids.||||<0.001
71097210|NCT03203512|141703327|SUPERIORITY||||||=|0.016||||||Treatment: p=0.016; period: p=0.566; treatment x period interaction: p=0.659|ANOVA|||Null hypothesis is that there was no difference in change of plasma TAG between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on plasma TAG.||||=0.016
70982285|NCT01254344|141472637|SUPERIORITY_OR_OTHER||Difference in percentage of prophylaxis|1.3|||||TWO_SIDED|95.0|-2.2|5.1|||Miettinen and Nurminen|||||5.1|-2.2|
70982286|NCT01624194|141472651|OTHER|||||||0.0275|||||||General Linear Model (GLM)|||||||0.0275
70982287|NCT01624194|141472652|OTHER||||||>|0.05||||||Fisher's Exact Test was used to test for differences in adverse events between oxytocin-treated and placebo-treated individuals. A p-value of ≤0.05 would have been statistically significant.|Fisher Exact|||||||>0.05
70982288|NCT01624194|141472653|OTHER||||||>|0.05|||||||Mixed Models Analysis|A mixed-models analysis was used to compare between groups, and between baseline and Week 4.||||||>0.05
70982289|NCT01624194|141472656|OTHER|||||||0.3395|||||||General Linear Model (GLM)|||||||0.3395
70982290|NCT01624194|141472664|OTHER|||||||0.9757|||||||General Linear Model (GLM)|||||||0.9757
70982291|NCT01624194|141472665|OTHER||||||>|0.05|||||||Mixed Models Analysis|A mixed-models analysis was used to compare between groups, and between baseline and Week 4.||||||>0.05
70982292|NCT01624194|141472666|OTHER||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
70982293|NCT01624194|141472667|OTHER||||||>|0.05||||||For all blood pressure analyses.|Mixed Models Analysis|||||||>0.05
71097211|NCT03203512|141703327|SUPERIORITY||||||=|0.014||||||Treatment: p=0.014; period: p=0.842; treatment x period interaction: p=0.943|ANOVA|||Null hypothesis is that there was no difference in change of plasma LDL-C between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on plasma LDL-C.||||=0.014
70982294|NCT03199911|141472749|SUPERIORITY||Risk Ratio (RR)|0.0||||0.025|TWO_SIDED||||||Fisher Exact|||||||0.025
71036320|NCT03214588|141581554|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.162||0.718|TWO_SIDED|90.0|-0.18|0.37||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Cutting-Handling Utensils||0.37|-0.18|0.718
71036321|NCT03214588|141581554|SUPERIORITY||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.133||0.986|TWO_SIDED|90.0|0.08|0.52||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Cutting-Handling Utensils||0.52|0.08|0.986
71036322|NCT03214588|141581554|SUPERIORITY||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.148||0.153|TWO_SIDED|90.0|-0.4|0.09||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Dressing||0.09|-0.40|0.153
71036323|NCT03214588|141581554|SUPERIORITY||Least Squares Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.119||0.861|TWO_SIDED|90.0|-0.07|0.33||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Dressing||0.33|-0.07|0.861
71036324|NCT03214588|141581554|SUPERIORITY||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.12||0.443|TWO_SIDED|90.0|-0.22|0.18||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Dressing||0.18|-0.22|0.443
71036325|NCT03214588|141581554|SUPERIORITY||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.1||0.359|TWO_SIDED|90.0|-0.2|0.13||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Dressing||0.13|-0.20|0.359
71036326|NCT03214588|141581554|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.157||0.268|TWO_SIDED|90.0|-0.36|0.17||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Dressing||0.17|-0.36|0.268
71097212|NCT03203512|141703327|SUPERIORITY||||||=|0.077||||||Treatment: p=0.077; period: p=0.921; treatment x period interaction: p=0.793|ANOVA|||Null hypothesis is that there was no difference in change of plasma TC between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on plasma TC.||||=0.077
70982295|NCT03199911|141472751|SUPERIORITY||Risk Ratio (RR)|1.3||||0.77|TWO_SIDED|95.0|0.42|4.03|||Fisher Exact|||||4.03|0.42|0.77
70982296|NCT03199911|141472752|SUPERIORITY||Risk Ratio (RR)|0.93||||1|TWO_SIDED|95.0|0.06|14.77|||Fisher Exact|||||14.77|0.06|1.00
70982297|NCT00698516|141472753|SUPERIORITY_OR_OTHER||Greenwood variance|65.0|STANDARD_ERROR_OF_MEAN|7.07||0.017|TWO_SIDED|95.0|49.3|76.9||Historical data in target population showed 3-month PFS rates of \<=50%. Oral topotecan with IV bevacizumab would provide clinically meaningful improvement in 3-month PFS if it could demonstrate a 40% improvement relative to the historical data.|Z statistic|Z statistic was used to reject the null hypothesis provided Z\>=1.65, where Z = (KM estimate at 3 months - null hypothesis value \[50%\])/Greenwood SE.||||76.9|49.3|0.017
70982298|NCT01142323|141472815|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|95.0|||||Matched pairs|||||||0.008
70982299|NCT01142323|141472816|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
70982300|NCT00345605|141472831|SUPERIORITY_OR_OTHER||Slope|0.5|||||TWO_SIDED||||||||Assuming r=0.5 between two measurements from the same subject, 12 subjects would provide a power of 0.8 to detect a 10% reduction in primary endpoints at an alpha value of 0.05.|For sample size calculation, we used the means and standard deviation for PT, PTT. Assuming r=0.5 between two measurements from the same subject, 12 subjects would provide a power of 0.8 to detect a 10% reduction in primary endpoints at an alpha value of 0.05.||||
70982301|NCT01335971|141472838|SUPERIORITY_OR_OTHER|||||||0.45|||||||Kruskal-Wallis|||Applies to gene expression of NAD(P)H Quinone Dehydrogenase 1 (NQ01) in alveolar macrophages||||0.45
70982302|NCT01335971|141472838|SUPERIORITY_OR_OTHER|||||||0.4|||||||Kruskal-Wallis|||Applies to gene expression of Heme Oxygenase 1 (HO1) in alveolar macrophages||||0.40
70982303|NCT01335971|141472838|SUPERIORITY_OR_OTHER|||||||0.75|||||||Kruskal-Wallis|||Applies to gene expression of Aldo-Keto Reductase Family 1 Member C1 (AKR1C1) in alveolar macrophages||||0.75
70982304|NCT01335971|141472838|SUPERIORITY_OR_OTHER|||||||0.49|||||||Kruskal-Wallis|||Applies to gene expression of Aldo-Keto Reductase Family 1 Member C3 (AKR1C3) in alveolar macrophages||||0.49
70982305|NCT01335971|141472838|SUPERIORITY_OR_OTHER|||||||0.88|||||||Kruskal-Wallis|||Applies to gene expression of nuclear factor erythroid 2 like 2 (Nrf2) in alveolar macrophages||||0.88
70982306|NCT01335971|141472838|SUPERIORITY_OR_OTHER|||||||0.71|||||||Kruskal-Wallis|||Applies to gene expression of Kelch Like ECH Associated Protein 1 (Keap1) in alveolar macrophages||||0.71
71097213|NCT03203512|141703327|SUPERIORITY||||||=|0.379||||||Treatment: p=0.379; period: p=0.938; treatment x period interaction: p=0.341|ANOVA|||Null hypothesis is that there was no difference in change of plasma HDL-C between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on plasma HDL-C.||||=0.379
70982307|NCT01335971|141472839|SUPERIORITY_OR_OTHER|||||||0.68|||||||Kruskal-Wallis|||Applies to gene expression of Nrf2 in bronchial epithelial cells||||0.68
70982308|NCT01335971|141472840|SUPERIORITY_OR_OTHER|||||||0.69|||||||Kruskal-Wallis|||Applies to gene expression of NAD(P)H Quinone Dehydrogenase 1 (NQ01) in bronchial epithelial cells||||0.69
70982309|NCT01335971|141472840|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Kruskal-Wallis|||Applies to gene expression of Kelch Like ECH Associated Protein 1 (Keap1) in bronchial epithelial cells||||<0.01
70982310|NCT01335971|141472841|SUPERIORITY_OR_OTHER|||||||0.53|||||||Kruskal-Wallis|||Applies to gene expression of Heme Oxygenase 1 (HO1) in bronchial epithelial cells||||0.53
70982311|NCT01335971|141472842|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Kruskal-Wallis|||Applies to gene expression of Aldo-Keto Reductase Family 1 Member C1 (AKR1C1) in bronchial epithelial cells.||||<0.01
70982312|NCT01335971|141472843|SUPERIORITY_OR_OTHER|||||||0.06|||||||Kruskal-Wallis|||Applies to gene expression of Aldo-Keto Reductase Family 1 Member C3 (AKR1C3) in bronchial epithelial cells.||||0.06
70982313|NCT01335971|141472844|SUPERIORITY_OR_OTHER|||||||0.2|||||||Kruskal-Wallis|||||||0.20
70982314|NCT01335971|141472845|SUPERIORITY_OR_OTHER|||||||0.41|||||||Kruskal-Wallis|||Applies to C-reactive protein concentration||||0.41
70982315|NCT01335971|141472845|SUPERIORITY_OR_OTHER|||||||0.07|||||||Kruskal-Wallis|||Applies to Interleukin-6 concentration||||0.07
70982316|NCT01335971|141472845|SUPERIORITY_OR_OTHER|||||||0.65|||||||Kruskal-Wallis|||Applies to Interleukin-8 concentration||||0.65
70982317|NCT01335971|141472846|SUPERIORITY_OR_OTHER|||||||0.71|||||||Kruskal-Wallis|||Applies to interleukin-8 results||||0.71
70982318|NCT01335971|141472846|SUPERIORITY_OR_OTHER|||||||0.33|||||||Kruskal-Wallis|||Applies to secretory leukoprotease inhibitor results||||0.33
70982319|NCT01335971|141472847|SUPERIORITY_OR_OTHER|||||||0.8|||||||Kruskal-Wallis|||Applies to isoprostane results.||||0.80
70982320|NCT01335971|141472847|SUPERIORITY_OR_OTHER|||||||0.35|||||||Kruskal-Wallis|||Applies to thiobarbituric acid reactive substances results.||||0.35
70982321|NCT01335971|141472847|SUPERIORITY_OR_OTHER|||||||0.53|||||||Kruskal-Wallis|||Applies to total antioxidants results.||||0.53
70982322|NCT00917384|141472857|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.776||||0.0473||95.0|0.603|0.998|||Stratified Log-Rank Test|Stratified Log-Rank Test and HR stratified by randomization strata (weight loss over the prior 3 months, primary tumor site and geographical region).||||0.998|0.603|0.0473
70982323|NCT00917384|141472858|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.483|||<|0.0001|TWO_SIDED|95.0|0.376|0.62|||Stratified Log-Rank Test|Stratified Log-Rank Test and HR stratified by randomization strata (weight loss over the prior 3 months, primary tumor site and geographical region).||||0.620|0.376|<0.0001
70982324|NCT00917384|141472859|SUPERIORITY_OR_OTHER_LEGACY||Difference Between Arms|24.2|||<|0.0001|TWO_SIDED|95.0|14.9|33.6|||Normal Approximation|||||33.6|14.9|<0.0001
70982325|NCT00149214|141472866|SUPERIORITY_OR_OTHER||Percentage of Participants|16.5||||||95.0|10.5|24.2||||||Confidence Interval for pathological complete response in the Pemetrexed treatment arm.||24.2|10.5|
70982326|NCT00149214|141472866|SUPERIORITY_OR_OTHER||Percentage of Participants|20.2||||||95.0|13.4|28.5||||||Confidence Interval for pathological complete response in the Cyclophosphamide treatment group.||28.5|13.4|
70982327|NCT00644592|141472875|SUPERIORITY_OR_OTHER||Ratio of mean effects|1.27|STANDARD_ERROR_OF_MEAN|0.16||0.015|TWO_SIDED|95.0|1.06|1.52|||t-test, 2 sided||The estimated mean log difference (SE) between the period 2 and period 1 effects and SE was estimated. This estimates twice the effect size\[since (B-A)-(A-B)=2B-2A\] so the actual estimate was based upon the antilog of half of this difference.|This is a crossover analysis. To convert to a ratio effect, the mean difference must be divided by two and antilogs take. The outcome represents a relative effect.||1.52|1.06|0.015
70982328|NCT00749606|141472900|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Mixed linear models analyzed within-subject variation in repeated measures over time. Intention to treat analysis used 5 imputations for missing data.||||||<0.01
70982329|NCT00892437|141472907|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than in the ATV+RTV+FTC/TDF group; alternative hypothesis: the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group. ATV+COBI+FTC/TDF was noninferior if the lower bound of the 2-sided 95% confidence interval (CI) of the baseline HIV-1 RNA stratum-weighted difference (COBI group - RTV group) in the response rate at Week 24 was greater than -12%.|Difference in percentages|-7.4|||||TWO_SIDED|95.0|-24.6|9.9|||||Difference in percentages of success and its 95% confidence interval (CI) were calculated based on baseline HIV-1 RNA stratum-adjusted Mantel-Haenszel (MH) proportion.|A total planned sample size of 75 subjects had 26% power to evaluate noninferiority with respect to the response rate of HIV-1 RNA \< 50 copies/mL at Week 24 if a response rate of 84% for both arms and a noninferiority margin of 0.12 were assumed.||9.9|-24.6|
70982330|NCT00892437|141472908|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than the response rate in ATV+RTV+FTC/TDF group; the alternative hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group.|Difference in percentages|-8.3|||||TWO_SIDED|95.0|-25.9|9.4|||||Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.|||9.4|-25.9|
70982331|NCT00892437|141472909|SUPERIORITY_OR_OTHER||Difference in least squares mean (LSM)|-0.02||||0.87|TWO_SIDED|95.0|-0.25|0.22||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in least squares mean (LSM) and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||0.22|-0.25|0.87
70982332|NCT00892437|141472910|SUPERIORITY_OR_OTHER||Difference in LSM|-0.03||||0.82|TWO_SIDED|95.0|-0.3|0.23||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||0.23|-0.30|0.82
70982333|NCT00892437|141472911|SUPERIORITY_OR_OTHER||Difference in LSM|10.0||||0.78|TWO_SIDED|95.0|-63.0|84.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||84|-63|0.78
70982334|NCT00892437|141472912|SUPERIORITY_OR_OTHER||Difference in LSM|47.0||||0.29|TWO_SIDED|95.0|-41.0|134.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||134|-41|0.29
71036327|NCT03214588|141581554|SUPERIORITY||Least Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.129||0.411|TWO_SIDED|90.0|-0.24|0.19||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Dressing||0.19|-0.24|0.411
71036328|NCT03214588|141581554|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.151||0.358|TWO_SIDED|90.0|-0.31|0.2||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Personal Hygiene||0.20|-0.31|0.358
71036329|NCT03214588|141581554|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.123||0.946|TWO_SIDED|90.0|0.0|0.41||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Personal Hygiene||0.41|0.00|0.946
71036330|NCT03214588|141581554|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.193||0.505|TWO_SIDED|90.0|-0.32|0.33||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Personal Hygiene||0.33|-0.32|0.505
71036331|NCT03214588|141581554|SUPERIORITY||Least Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.158||0.658|TWO_SIDED|90.0|-0.2|0.33||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Personal Hygiene||0.33|-0.20|0.658
71036332|NCT03214588|141581554|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.184||0.649|TWO_SIDED|90.0|-0.24|0.38||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Personal Hygiene||0.38|-0.24|0.649
71036333|NCT03214588|141581554|SUPERIORITY||Least Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.151||0.661|TWO_SIDED|90.0|-0.19|0.32||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Personal Hygiene||0.32|-0.19|0.661
71036334|NCT03214588|141581555|SUPERIORITY||Least Squares Mean Difference|2.67|STANDARD_ERROR_OF_MEAN|1.078||0.992|TWO_SIDED|90.0|0.86|4.47||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||4.47|0.86|0.992
71036335|NCT03214588|141581555|SUPERIORITY||Least Squares Mean Difference|2.78|STANDARD_ERROR_OF_MEAN|0.892||0.999|TWO_SIDED|90.0|1.29|4.28||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||4.28|1.29|0.999
71036336|NCT03214588|141581555|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.338||0.616|TWO_SIDED|90.0|-1.84|2.64||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||2.64|-1.84|0.616
71036337|NCT03214588|141581555|SUPERIORITY||Least Squares Mean Difference|1.06|STANDARD_ERROR_OF_MEAN|1.131||0.823|TWO_SIDED|90.0|-0.83|2.95||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||2.95|-0.83|0.823
71036338|NCT03214588|141581555|SUPERIORITY||Least Squares Mean Difference|2.02|STANDARD_ERROR_OF_MEAN|1.266||0.942|TWO_SIDED|90.0|-0.1|4.13||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||4.13|-0.10|0.942
71036339|NCT03214588|141581555|SUPERIORITY||Least Squares Mean Difference|2.11|STANDARD_ERROR_OF_MEAN|1.053||0.975|TWO_SIDED|90.0|0.35|3.87||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||3.87|0.35|0.975
71097214|NCT03203512|141703328|SUPERIORITY||||||=|0.285||||||Treatment: p=0.285; period: p=0.954; treatment x period interaction: p=0.528|ANOVA|||Null hypothesis is that there was no difference in change of plasma TC/HDL-C ratio between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on plasma TC/HDL-C ratio.||||=0.285
71097215|NCT03203512|141703329|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period effect: p=0.011; treatment x period interaction: p=0.033|ANOVA|||Null hypothesis is that there was no difference in change of SBP between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on SBP.||||<0.001
71036340|NCT03214588|141581556|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|90.0|-0.15|0.29||||||Change at Week 2, Bulbar||0.29|-0.15|
71097216|NCT03203512|141703329|SUPERIORITY||||||=|0.002||||||Treatment: p=0.002; period: p=0.952; treatment x period interaction: p=0.114|ANOVA|||Null hypothesis is that there was no difference in change of DBP between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on DBP.||||=0.002
71097217|NCT02933476|141703342|SUPERIORITY||||||>|0.05|||||||ANOVA|||We compared off therapy UPDRS III scores at baseline to one and four weeks after stimulation.||||>0.05
71097218|NCT02933476|141703343|SUPERIORITY|||||||0.008|||||||ANOVA|||||||0.008
71036341|NCT03214588|141581556|SUPERIORITY||Least Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.12|0.25||||||Change at Week 2, Bulbar||0.25|-0.12|
71036342|NCT03214588|141581556|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.122|||TWO_SIDED|90.0|-0.3|0.11||||||Change at Week 7, Bulbar||0.11|-0.30|
71036343|NCT03214588|141581556|SUPERIORITY||Least Squares Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|90.0|-0.02|0.33||||||Change at Week 7, Bulbar||0.33|-0.02|
71036344|NCT03214588|141581556|SUPERIORITY||Least Squares Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|90.0|-0.19|0.28||||||Change at Week 12, Bulbar||0.28|-0.19|
71036345|NCT03214588|141581556|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.118|||TWO_SIDED|90.0|0.0|0.4||||||Change at Week 12, Bulbar||0.40|0.00|
71036346|NCT03214588|141581556|SUPERIORITY||Least Squares Mean Difference|1.99|STANDARD_ERROR_OF_MEAN|0.689|||TWO_SIDED|90.0|0.83|3.14||||||Change at Week 2, Upper Limb Coordination||3.14|0.83|
71036347|NCT03214588|141581556|SUPERIORITY||Least Squares Mean Difference|1.02|STANDARD_ERROR_OF_MEAN|0.571|||TWO_SIDED|90.0|0.06|1.97||||||Change at Week 2, Upper Limb Coordination||1.97|0.06|
71036348|NCT03214588|141581556|SUPERIORITY||Least Squares Mean Difference|1.08|STANDARD_ERROR_OF_MEAN|0.882|||TWO_SIDED|90.0|-0.4|2.55||||||Change at Week 7, Upper Limb Coordination||2.55|-0.40|
71036349|NCT03214588|141581556|SUPERIORITY||Least Squares Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.743|||TWO_SIDED|90.0|-1.06|1.43||||||Change at Week 7, Upper Limb Coordination||1.43|-1.06|
71036350|NCT03214588|141581556|SUPERIORITY||Least Squares Mean Difference|1.21|STANDARD_ERROR_OF_MEAN|1.016|||TWO_SIDED|90.0|-0.48|2.91||||||Change at Week 12, Upper Limb Coordination||2.91|-0.48|
71036351|NCT03214588|141581556|SUPERIORITY||Least Squares Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|90.0|-0.87|1.94||||||Change at Week 12, Upper Limb Coordination||1.94|-0.87|
71036352|NCT03214588|141581556|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.482|||TWO_SIDED|90.0|-0.41|1.2||||||Change at Week 2, Lower Limb Coordination||1.20|-0.41|
71036353|NCT03214588|141581556|SUPERIORITY||Least Squares Mean Difference|0.79|STANDARD_ERROR_OF_MEAN|0.397|||TWO_SIDED|90.0|0.12|1.45||||||Change at Week 2, Lower Limb Coordination||1.45|0.12|
71036354|NCT03214588|141581556|SUPERIORITY||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.837|||TWO_SIDED|90.0|-1.44|1.36||||||Change at Week 7, Lower Limb Coordination||1.36|-1.44|
71036355|NCT03214588|141581556|SUPERIORITY||Least Squares Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.707|||TWO_SIDED|90.0|-1.01|1.36||||||Change at Week 7, Lower Limb Coordination||1.36|-1.01|
71036356|NCT03214588|141581556|SUPERIORITY||Least Squares Mean Difference|0.99|STANDARD_ERROR_OF_MEAN|0.755|||TWO_SIDED|90.0|-0.27|2.25||||||Change at Week 12, Lower Limb Coordination||2.25|-0.27|
71036357|NCT03214588|141581556|SUPERIORITY||Least Squares Mean Difference|0.95|STANDARD_ERROR_OF_MEAN|0.626|||TWO_SIDED|90.0|-0.09|2.0||||||Change at Week 12, Lower Limb Coordination||2.00|-0.09|
71036358|NCT03214588|141581556|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|90.0|-0.8|1.3||||||Change at Week 2, Upright Stability||1.3|-0.8|
71036359|NCT03214588|141581556|SUPERIORITY||Least Squares Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|90.0|0.1|1.9||||||Change at Week 2, Upright Stability||1.9|0.1|
71036360|NCT03214588|141581556|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|90.0|-1.3|0.2||||||Change at Week 7, Upright Stability||0.2|-1.3|
71036361|NCT03214588|141581556|SUPERIORITY||Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|90.0|0.0|1.2||||||Change at Week 7, Upright Stability||1.2|0.0|
71036362|NCT03214588|141581556|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|90.0|-1.2|0.7||||||Change at Week 12, Upright Stability||0.7|-1.2|
71036363|NCT03214588|141581556|SUPERIORITY||Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|90.0|-0.3|1.3||||||Change at Week 12, Upright Stability||1.3|-0.3|
71036364|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.084|||TWO_SIDED|90.0|-0.13|0.15||||||Change at Week 2, Cough||0.15|-0.13|
71036365|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.069|||TWO_SIDED|90.0|-0.11|0.12||||||Change at Week 2, Cough||0.12|-0.11|
71036366|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.105|||TWO_SIDED|90.0|-0.24|0.11||||||Change at Week 7, Cough||0.11|-0.24|
71036367|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.088|||TWO_SIDED|90.0|-0.05|0.25||||||Change at Week 7, Cough||0.25|-0.05|
71036368|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.106|||TWO_SIDED|90.0|-0.11|0.25||||||Change at Week 12, Cough||0.25|-0.11|
71036369|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.087|||TWO_SIDED|90.0|-0.03|0.26||||||Change at Week 12, Cough||0.26|-0.03|
71097219|NCT02933476|141703344|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
71097220|NCT00191152|141703386|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||Log Rank|||||||0.145
70982335|NCT02750410|141472915|SUPERIORITY||LS mean percent difference|-1.5|||<|0.001|TWO_SIDED|95.0|-1.73|-1.28|||Mixed Models Analysis|||||-1.28|-1.73|<0.001
70982336|NCT02750410|141472916|SUPERIORITY||Odds Ratio (OR)|0.117||||0.003|TWO_SIDED|95.0|0.028|0.479|||Regression, Logistic|||analysis was based on repeated measures logistic regression||0.479|0.028|0.003
70982337|NCT02750410|141472917|SUPERIORITY||LS mean difference|-30.14|||<|0.001|TWO_SIDED|95.0|-41.37|-18.91|||Mixed Models Analysis|||||-18.91|-41.37|<0.001
70982338|NCT02750410|141472918|SUPERIORITY||LS mean difference|-26.59|||<|0.001|TWO_SIDED|95.0|-36.39|-16.78|||t-test, 2 sided|||Prebreakfast BG||-16.78|-36.39|<0.001
70982339|NCT02750410|141472918|SUPERIORITY||LS mean difference|-45.38|||<|0.001|TWO_SIDED|95.0|-61.77|-29.0|||t-test, 2 sided|||Breakfast 2-hour PPBG||-29.00|-61.77|<0.001
70982340|NCT02750410|141472918|SUPERIORITY||LS mean difference|-36.82|||<|0.001|TWO_SIDED|95.0|-49.2|-24.45|||t-test, 2 sided|||Prelunch BG||-24.45|-49.20|<0.001
70982341|NCT02750410|141472918|SUPERIORITY||LS mean difference|-50.16|||<|0.001|TWO_SIDED|95.0|-67.85|-32.46|||t-test, 2 sided|||Lunch 2-hour PPBG||-32.46|-67.85|<0.001
70982342|NCT02750410|141472918|SUPERIORITY||LS mean difference|-31.27|||<|0.001|TWO_SIDED|95.0|-44.05|-18.48|||t-test, 2 sided|||Predinner BG||-18.48|-44.05|<0.001
70982343|NCT02750410|141472918|SUPERIORITY||LS mean difference|-34.97|||<|0.001|TWO_SIDED|95.0|-52.55|-17.38|||t-test, 2 sided|||Dinner 2-hour PPBG||-17.38|-52.55|<0.001
70982344|NCT02750410|141472918|SUPERIORITY||LS mean difference|-41.45|||<|0.001|TWO_SIDED|95.0|-58.81|-24.09|||t-test, 2 sided|||Bedtime BG||-24.09|-58.81|<0.001
70982345|NCT02750410|141472919|SUPERIORITY||LS mean difference|0.1||||0.776|TWO_SIDED|95.0|-0.59|0.78|||Mixed Models Analysis|||||0.78|-0.59|0.776
70982346|NCT01238120|141472926|SUPERIORITY|||||||0.9168|||||||ANCOVA|||||||0.9168
70982347|NCT01238120|141472927|SUPERIORITY|||||||0.6536|||||||ANCOVA|||||||0.6536
70982348|NCT04112914|141472944|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.021|TWO_SIDED||||||Regression, Linear|||||||0.021
70982349|NCT04112914|141472945|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.638|TWO_SIDED||||||Regression, Linear|||||||0.638
70982350|NCT04112914|141472946|SUPERIORITY||Odds Ratio (OR)|1.77||||0.338|TWO_SIDED|95.0|0.55|5.72|||Regression, Logistic|||||5.72|0.55|0.338
70982351|NCT04112914|141472947|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.606|TWO_SIDED||||||Regression, Linear|||||||0.606
70982352|NCT04112914|141472948|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.508|TWO_SIDED||||||Regression, Linear|||||||0.508
70982353|NCT04112914|141472949|SUPERIORITY||Mean Difference (Final Values)|0.45||||0.042|TWO_SIDED||||||Regression, Linear|||||||0.042
70982354|NCT04112914|141472950|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.128|TWO_SIDED||||||Regression, Linear|||||||0.128
70982355|NCT02580058|141473004|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.8253|TWO_SIDED|95.0|0.867|1.497|||Log Rank|1-sided||||1.497|0.867|0.8253
70982356|NCT02580058|141473004|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.2082|TWO_SIDED|95.0|0.672|1.179|||Log Rank|1-sided||||1.179|0.672|0.2082
70982357|NCT02580058|141473005|SUPERIORITY||Hazard Ratio (HR)|1.68|||>|0.9999|TWO_SIDED|95.0|1.31|2.16|||Log Rank|1-sided||||2.160|1.310|>0.9999
70982358|NCT02580058|141473005|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0301|TWO_SIDED|95.0|0.607|1.011|||Log Rank|1-sided||||1.011|0.607|0.0301
70982359|NCT02580058|141473024|OTHER||Geometric Mean Ratio (Test/Reference, %)|110.0|||||TWO_SIDED|90.0|95.4|126.7||||||Avelumab was the Reference treatment and Avelumab + PLD was the Test treatment||126.7|95.4|
70982360|NCT02580058|141473025|OTHER||Geometric Mean Ratio (Test/Reference, %)|90.0|||||TWO_SIDED|90.0|79.5|101.5||||||Avelumab was the Reference treatment and Avelumab + PLD was the Test treatment||101.5|79.5|
70982361|NCT02580058|141473026|OTHER||Geometric Mean Ratio (Test/Reference, %)|96.0|||||TWO_SIDED|90.0|87.0|106.0||||||PLD was the Reference treatment and Avelumab + PLD was the Test treatment.||106|87|
70982362|NCT02580058|141473027|OTHER||Geometric Mean Ratio (Test/Reference, %)|95.0|||||TWO_SIDED|90.0|88.0|104.0||||||PLD was the Reference treatment and Avelumab + PLD was the Test treatment.||104|88|
70982363|NCT02580058|141473028|OTHER||Geometric Mean Ratio (Test/Reference, %)|90.0|||||TWO_SIDED|90.0|76.0|107.0||||||PLD was the Reference treatment and Avelumab + PLD was the Test treatment.||107|76|
70982364|NCT02580058|141473029|OTHER||Geometric Mean Ratio (Test/Reference, %)|100.0|||||TWO_SIDED|90.0|60.0|168.0||||||PLD was the Reference treatment and Avelumab + PLD was the Test treatment.||168|60|
70982365|NCT03826914|141473051|SUPERIORITY||Median Difference (Net)|-0.43||||0.042|TWO_SIDED|95.0|-0.846|-0.015||The threshold of significance was P=0.05|Anaylsis of Covariance||Placebo - Cardioflex|The primary analysis was conducted using the post-treatment biomarker value, comparing the two groups, and controlling for their baseline values by using analysis of covariance. In this study, the dependent variable was the biomarkers being tested, the controlled independent variable was the treatment given and the uncontrolled variables were the baseline differences between participants.||-0.015|-0.846|0.042
70982366|NCT03826914|141473052|SUPERIORITY||Mean Difference (Final Values)|-6.772||||0.04|TWO_SIDED|95.0|-11.2|-2.24||The threshold of significance was P=0.05|Anaylsis of Covariance|||The primary analysis was conducted using the post-treatment biomarker value, comparing the two groups, and controlling for their baseline values by using analysis of covariance. In this study, the dependent variable was the biomarkers being tested, the controlled independent variable was the treatment given and the uncontrolled variables were the baseline differences between participants.||-2.24|-11.2|0.04
70982367|NCT04334148|141473053|OTHER|||||||0.2|||||||Fisher Exact|||||||0.200
70982368|NCT04334148|141473054|OTHER|||||||1|||||||Regression, Linear|||||||1.0
70982369|NCT04334148|141473055|SUPERIORITY|||||||0.802|||||||Chi-squared|||||||0.802
70982370|NCT04246047|141473086|SUPERIORITY||Hazard Ratio (HR)|0.41|||<|1e-05||95.0|0.31|0.53|||one-sided stratified log-rank||Hazard ratio was estimated using a Cox Proportional Hazards model stratified by the number of lines of prior therapy, prior bortezomib and revised international staging system (R-ISS) at screening, with a covariate of treatment.|||0.53|0.31|<0.00001
71097221|NCT00191152|141703387|SUPERIORITY_OR_OTHER|||||||0.361||95.0|||||Log Rank|||||||0.361
71097222|NCT00191152|141703388|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||Log Rank|||||||0.145
71097223|NCT00191152|141703389|SUPERIORITY_OR_OTHER|||||||0.385||95.0|||||Log Rank|||||||0.385
71097224|NCT00191152|141703390|SUPERIORITY_OR_OTHER|||||||0.377||95.0|||||Log Rank|||||||0.377
71097225|NCT00191152|141703391|SUPERIORITY_OR_OTHER|||||||0.446||95.0|||||Log Rank|||||||0.446
71036370|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|-0.09|0.25||||||Change at Week 2, Speech||0.25|-0.09|
71036371|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.083|||TWO_SIDED|90.0|-0.04|0.24||||||Change at Week 2, Speech||0.24|-0.04|
71036372|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.071|||TWO_SIDED|90.0|-0.16|0.08||||||Change at Week 7, Speech||0.08|-0.16|
71036373|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|90.0|-0.03|0.17||||||Change at Week 7, Speech||0.17|-0.03|
71036374|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.095|||TWO_SIDED|90.0|-0.16|0.16||||||Change at Week 12, Speech||0.16|-0.16|
71036375|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.079|||TWO_SIDED|90.0|-0.04|0.22||||||Change at Week 12, Speech||0.22|-0.04|
71036376|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.131|||TWO_SIDED|90.0|-0.14|0.29||||||Change at Week 2, Right Finger to Finger Test||0.29|-0.14|
71036377|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.108|||TWO_SIDED|90.0|-0.22|0.14||||||Change at Week 2, Right Finger to Finger Test||0.14|-0.22|
71036378|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.122|||TWO_SIDED|90.0|-0.13|0.28||||||Change at Week 7, Right Finger to Finger Test||0.28|-0.13|
71036379|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.103|||TWO_SIDED|90.0|-0.24|0.11||||||Change at Week 7, Right Finger to Finger Test||0.11|-0.24|
71036380|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.126|||TWO_SIDED|90.0|-0.3|0.12||||||Change at Week 12, Right Finger to Finger Test||0.12|-0.30|
71036381|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|90.0|-0.32|0.03||||||Change at Week 12, Right Finger to Finger Test||0.03|-0.32|
71036382|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.142|||TWO_SIDED|90.0|-0.15|0.33||||||Change at Week 2, Left Finger to Finger Test||0.33|-0.15|
71036383|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.117|||TWO_SIDED|90.0|-0.16|0.23||||||Change at Week 2, Left Finger to Finger Test||0.23|-0.16|
71036384|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.123|||TWO_SIDED|90.0|-0.18|0.23||||||Change at Week 7, Left Finger to Finger Test||0.23|-0.18|
71036385|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|90.0|-0.15|0.2||||||Change at Week 7, Left Finger to Finger Test||0.20|-0.15|
71036386|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.158|||TWO_SIDED|90.0|-0.17|0.36||||||Change at Week 12, Left Finger to Finger Test||0.36|-0.17|
71036387|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.3|0.13||||||Change at Week 12, Left Finger to Finger Test||0.13|-0.30|
71036388|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.145|||TWO_SIDED|90.0|0.04|0.53||||||Change at Week 2, Right Nose to Finger Test||0.53|0.04|
71036389|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.118|||TWO_SIDED|90.0|-0.06|0.33||||||Change at Week 2, Right Nose to Finger Test||0.33|-0.06|
71036390|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.174|||TWO_SIDED|90.0|-0.22|0.37||||||Change at Week 7, Right Nose to Finger Test||0.37|-0.22|
71036391|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.146|||TWO_SIDED|90.0|-0.32|0.16||||||Change at Week 7, Right Nose to Finger Test||0.16|-0.32|
71036392|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.166|||TWO_SIDED|90.0|-0.43|0.12||||||Change at Week 12, Right Nose to Finger Test||0.12|-0.43|
71036393|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.136|||TWO_SIDED|90.0|-0.23|0.23||||||Change at Week 12, Right Nose to Finger Test||0.23|-0.23|
71036394|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.161|||TWO_SIDED|90.0|-0.14|0.4||||||Change at Week 2, Left Nose to Finger Test||0.40|-0.14|
71036395|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|90.0|-0.12|0.33||||||Change at Week 2, Left Nose to Finger Test||0.33|-0.12|
71036396|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.157|||TWO_SIDED|90.0|-0.09|0.43||||||Change at Week 7, Left Nose to Finger Test||0.43|-0.09|
71036397|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.134|||TWO_SIDED|90.0|-0.36|0.09||||||Change at Week 7, Left Nose to Finger Test||0.09|-0.36|
71036398|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.169|||TWO_SIDED|90.0|-0.29|0.27||||||Change at Week 12, Left Nose to Finger Test||0.27|-0.29|
71036399|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|90.0|-0.21|0.27||||||Change at Week 12, Left Nose to Finger Test||0.27|-0.21|
71036400|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.176|||TWO_SIDED|90.0|-0.33|0.26||||||Change at Week 2, Right Dysmetria Test||0.26|-0.33|
71036401|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.145|||TWO_SIDED|90.0|-0.12|0.36||||||Change at Week 2, Right Dysmetria Test||0.36|-0.12|
71036402|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.217|||TWO_SIDED|90.0|-0.25|0.48||||||Change at Week 7, Right Dysmetria Test||0.48|-0.25|
71036403|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.183|||TWO_SIDED|90.0|-0.14|0.47||||||Change at Week 7, Right Dysmetria Test||0.47|-0.14|
71036404|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.221|||TWO_SIDED|90.0|-0.26|0.48||||||Change at Week 12, Right Dysmetria Test||0.48|-0.26|
71036405|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.183|||TWO_SIDED|90.0|-0.36|0.25||||||Change at Week 12, Right Dysmetria Test||0.25|-0.36|
71036406|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.185|||TWO_SIDED|90.0|-0.02|0.6||||||Change at Week 2, Left Dysmetria Test||0.60|-0.02|
71036407|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.153|||TWO_SIDED|90.0|-0.1|0.41||||||Change at Week 2, Left Dysmetria Test||0.41|-0.10|
71097226|NCT00191152|141703392|SUPERIORITY_OR_OTHER|||||||0.785||95.0|||||Log Rank|||||||0.785
71036408|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.228|||TWO_SIDED|90.0|-0.63|0.13||||||Change at Week 7, Left Dysmetria Test||0.13|-0.63|
71036409|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.192|||TWO_SIDED|90.0|-0.47|0.18||||||Change at Week 7, Left Dysmetria Test||0.18|-0.47|
71036410|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.254|||TWO_SIDED|90.0|-0.37|0.48||||||Change at Week 12, Left Dysmetria Test||0.48|-0.37|
71036411|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.209|||TWO_SIDED|90.0|-0.11|0.58||||||Change at Week 12, Left Dysmetria Test||0.58|-0.11|
71036412|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.06|0.51||||||Change at Week 2, RAM of Right Hands||0.51|-0.06|
71036413|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|90.0|-0.12|0.35||||||Change at Week 2, RAM of Right Hands||0.35|-0.12|
71036414|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.204|||TWO_SIDED|90.0|-0.41|0.28||||||Change at Week 7, RAM of Right Hands||0.28|-0.41|
71036415|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.172|||TWO_SIDED|90.0|-0.29|0.29||||||Change at Week 7, RAM of Right Hands||0.29|-0.29|
71036416|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.187|||TWO_SIDED|90.0|-0.12|0.51||||||Change at Week 12, RAM of Right Hands||0.51|-0.12|
71036417|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.156|||TWO_SIDED|90.0|-0.31|0.21||||||Change at Week 12, RAM of Right Hands||0.21|-0.31|
71036418|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|90.0|-0.15|0.32||||||Change at Week 2, RAM of Left Hands||0.32|-0.15|
71036419|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|90.0|-0.12|0.27||||||Change at Week 2, RAM of Left Hands||0.27|-0.12|
71036420|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.209|||TWO_SIDED|90.0|-0.27|0.43||||||Change at Week 7, RAM of Left Hands||0.43|-0.27|
71036421|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.176|||TWO_SIDED|90.0|-0.17|0.42||||||Change at Week 7, RAM of Left Hands||0.42|-0.17|
71036422|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.159|||TWO_SIDED|90.0|0.04|0.58||||||Change at Week 12, RAM of Left Hand||0.58|0.04|
71097227|NCT00191152|141703393|SUPERIORITY_OR_OTHER|||||||0.364||95.0|||||Fisher Exact|||||||0.364
71097228|NCT00191152|141703394|SUPERIORITY_OR_OTHER|||||||0.446||95.0|||||Fisher Exact|||||||0.446
71097229|NCT00191152|141703395|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||Mixed Models Analysis|||||||0.990
71097230|NCT00191152|141703396|SUPERIORITY_OR_OTHER|||||||0.117||95.0|||||Mixed Models Analysis|||||||0.117
71097231|NCT00191152|141703397|SUPERIORITY_OR_OTHER|||||||0.801||95.0|||||Mixed Models Analysis|||||||0.801
71097232|NCT00191152|141703398|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||Mixed Models Analysis|||||||0.190
71097233|NCT00114777|141703408|SUPERIORITY_OR_OTHER||Treament Difference|1.1|||||TWO_SIDED|97.3|-7.2|9.4|||||The treatment differences between each belatacept treatment group and cyclosporin group was tested at the 0.027 significance level for participant and graft survival (based on 10% non-inferiority margin).|||9.4|-7.2|
71036423|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|90.0|-0.01|0.43||||||Change at Week 12, RAM of Left Hand||0.43|-0.01|
71036424|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.201|||TWO_SIDED|90.0|0.1|0.77||||||Change at Week 2, Right Finger Taps||0.77|0.10|
71036425|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.168|||TWO_SIDED|90.0|-0.12|0.44||||||Change at Week 2, Right Finger Taps||0.44|-0.12|
71036426|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.227|||TWO_SIDED|90.0|-0.16|0.6||||||Change at Week 7, Right Finger Taps||0.60|-0.16|
71036427|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.193|||TWO_SIDED|90.0|-0.33|0.31||||||Change at Week 7, Right Finger Taps||0.31|-0.33|
71097234|NCT00114777|141703408|SUPERIORITY_OR_OTHER||Treatment difference|3.2|||||TWO_SIDED|97.3|-5.0|11.4|||||The treatment differences between each belatacept treatment group and cyclosporin group was tested at the 0.027 significance level for participant and graft survival (based on 10% non-inferiority margin).|||11.4|-5.0|
71097235|NCT00114777|141703409|SUPERIORITY_OR_OTHER||Percentage difference|-14.4||||0.0018|TWO_SIDED|97.3|-24.0|-4.7|||Chi-squared||A continuity-corrected chi-squared test at the significance level 0.027 was performed to assess the effect of each belatacept regimen compared with cyclosporin A.|||-4.7|-24|0.0018
71036428|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.233|||TWO_SIDED|90.0|-0.22|0.56||||||Change at Week 12, Right Finger Taps||0.56|-0.22|
71036429|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.194|||TWO_SIDED|90.0|-0.39|0.26||||||Change at Week 12, Right Finger Taps||0.26|-0.39|
71097236|NCT00114777|141703409|SUPERIORITY_OR_OTHER||Percentage difference|-8.5||||0.0616|TWO_SIDED|97.3|-18.0|0.9|||Chi-squared||A continuity-corrected chi-squared test at the significance level 0.027 was performed to assess the effect of each belatacept regimen compared with cyclosporin A.|||0.9|-18|0.0616
71097237|NCT00682838|141703453|SUPERIORITY_OR_OTHER|||||||0.5|||||||t-test, 1 sided|||||||0.50
71097238|NCT03566550|141703459|OTHER|||||||0.04|||||||Log Rank|||||||0.04
71097239|NCT03566550|141703460|OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
71097240|NCT03566550|141703461|OTHER|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
71097241|NCT03566550|141703462|OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
71097242|NCT03566550|141703463|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
70982371|NCT05139030|141473133|SUPERIORITY|A one-sided hypothesis test was performed at alpha=0.025 level of significance comparing EXPAREL admix and bupivacaine HCI|Mean Difference (Final Values)|-65.8|STANDARD_ERROR_OF_MEAN|26.97||0.0074|TWO_SIDED|95.0|-118.7|-12.9|||ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||The superiority of EXPAREL admixed to bupivacaine HCI was evaluated using the Efficacy Analysis Set.||-12.9|-118.7|0.0074
70982372|NCT05139030|141473134|SUPERIORITY|A one-sided hypothesis test was performed at alpha=0.025 level of significance comparing EXPAREL admix and bupivacaine HCI|Mean Ratio|0.77||||0.0018|TWO_SIDED|95.0|0.64|0.92|||ANCOVA|Total opioid consumption was transformed to log scale. Main effect of treatment, covariates: pooled Investigator site (categorical); age (continuous)||The superiority of EXPAREL admixed to bupivacaine HCI was evaluated using the Efficacy Analysis Set.||0.92|0.64|0.0018
70982373|NCT05139030|141473135|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0127|TWO_SIDED|95.0|0.51|0.96|||Cox proportional hazards model|Cox proportional hazard model: treatment as main effect, pooled Investigator site as categorical, and age and height as continuous covariates||||0.96|0.51|0.0127
70982374|NCT05139030|141473136|SUPERIORITY||Least square mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.3674|TWO_SIDED|95.0|-0.6|0.4||Worst pain 0-24 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.4|-0.6|0.3674
70982375|NCT05139030|141473136|SUPERIORITY||Least square mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.29||0.1016|TWO_SIDED|95.0|-0.9|0.2||Worst pain 24-48 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.2|-0.9|0.1016
70982376|NCT05139030|141473136|SUPERIORITY||Least square mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.34||0.0215|TWO_SIDED|95.0|-1.4|0.0||Worst pain 48-72 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-0.0|-1.4|0.0215
71036430|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.223|||TWO_SIDED|90.0|0.12|0.87||||||Change at Week 2, Left Finger Taps||0.87|0.12|
71036431|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.183|||TWO_SIDED|90.0|-0.25|0.36||||||Change at Week 2, Left Finger Taps||0.36|-0.25|
71036432|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.218|||TWO_SIDED|90.0|0.22|0.95||||||Change at Week 7, Left Finger Taps||0.95|0.22|
71097243|NCT02618187|141703469|OTHER|Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks||||||0.766|||||||Wilcoxon (Mann-Whitney)|2-sided||||||0.766
71097244|NCT02618187|141703469|OTHER|Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks||||||0.037|||||||Wilcoxon (Mann-Whitney)|2-sided||||||0.037
70982377|NCT05139030|141473136|SUPERIORITY||Least square mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.34||0.0794|TWO_SIDED|95.0|-1.2|0.2||Worst pain 72-96 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.2|-1.2|0.0794
70982378|NCT05139030|141473136|SUPERIORITY||Least square mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.29||0.3606|TWO_SIDED|95.0|-0.7|0.5||Average pain 0-24 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.5|-0.7|0.3606
70982379|NCT05139030|141473136|SUPERIORITY||Least square mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.28||0.0184|TWO_SIDED|95.0|-1.1|0.0||Average pain 24-48 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-0.0|-1.1|0.0184
70982380|NCT05139030|141473136|SUPERIORITY||Least square mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.31||0.0476|TWO_SIDED|95.0|-1.1|0.1||Average pain 48-72 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.1|-1.1|0.0476
70982381|NCT05139030|141473136|SUPERIORITY||Least square mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.31||0.0529|TWO_SIDED|95.0|-1.1|0.1||Average pain 72-96 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.1|-1.1|0.0529
70982382|NCT01982630|141473141|OTHER||Difference of Least Squares Means|-0.23|||||TWO_SIDED|90.0|-4.59|4.13|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||4.13|-4.59|
71036433|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.184|||TWO_SIDED|90.0|-0.15|0.47||||||Change at Week 7, Left Finger Taps||0.47|-0.15|
71036434|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.57|STANDARD_ERROR_OF_MEAN|0.272|||TWO_SIDED|90.0|0.11|1.02||||||Change at Week 12, Left Finger Taps||1.02|0.11|
71036435|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.224|||TWO_SIDED|90.0|-0.04|0.71||||||Change at Week 12, Left Finger Taps||0.71|-0.04|
71036436|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.193|||TWO_SIDED|90.0|-0.12|0.53||||||Change at Week 2, Right Heel Along Shin Slide||0.53|-0.12|
71036437|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.161|||TWO_SIDED|90.0|-0.26|0.27||||||Change at Week 2, Right Heel Along Shin Slide||0.27|-0.26|
71036438|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.251|||TWO_SIDED|90.0|-0.56|0.28||||||Change at Week 7, Right Heel Along Shin Slide||0.28|-0.56|
71036439|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.214|||TWO_SIDED|90.0|-0.53|0.19||||||Change at Week 7, Right Heel Along Shin Slide||0.19|-0.53|
71036440|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-0.12|0.78||||||Change at Week 12,Right Heel Along Shin Slide||0.78|-0.12|
71036441|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.226|||TWO_SIDED|90.0|-0.25|0.51||||||Change at Week 12,Right Heel Along Shin Slide||0.51|-0.25|
71036442|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.205|||TWO_SIDED|90.0|-0.51|0.18||||||Change at Week 2, Left Heel Along Shin Slide||0.18|-0.51|
71036443|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.166|||TWO_SIDED|90.0|-0.25|0.31||||||Change at Week 2, Left Heel Along Shin Slide||0.31|-0.25|
71036444|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.224|||TWO_SIDED|90.0|-0.68|0.07||||||Change at Week 7, Left Heel Along Shin Slide||0.07|-0.68|
71036445|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.188|||TWO_SIDED|90.0|-0.48|0.15||||||Change at Week 7, Left Heel Along Shin Slide||0.15|-0.48|
71036446|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.254|||TWO_SIDED|90.0|-0.45|0.4||||||Change at Week 12, Left Heel Along Shin Slide||0.40|-0.45|
71036447|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.209|||TWO_SIDED|90.0|-0.34|0.36||||||Change at Week 12, Left Heel Along Shin Slide||0.36|-0.34|
71036448|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.187|||TWO_SIDED|90.0|-0.1|0.53||||||Change at Week 2, Right Heel Along Shin Tap||0.53|-0.10|
71036449|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.155|||TWO_SIDED|90.0|0.17|0.69||||||Change at Week 2, Right Heel Along Shin Tap||0.69|0.17|
71036450|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.272|||TWO_SIDED|90.0|-0.72|0.19||||||Change at Week 7, Right Heel Along Shin Tap||0.19|-0.72|
71036451|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.231|||TWO_SIDED|90.0|-0.38|0.39||||||Change at Week 7, Right Heel Along Shin Tap||0.39|-0.38|
71097245|NCT02618187|141703469|OTHER|Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks||||||0.313|||||||Wilcoxon (Mann-Whitney)|2-sided||||||0.313
71036452|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.222|||TWO_SIDED|90.0|-0.23|0.51||||||Change at Week 12, Right Heel Along Shin Tap||0.51|-0.23|
71036453|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.186|||TWO_SIDED|90.0|0.02|0.64||||||Change at Week 12, Right Heel Along Shin Tap||0.64|0.02|
71036454|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.199|||TWO_SIDED|90.0|-0.17|0.5||||||Change at Week 2, Left Heel Along Shin Tap||0.50|-0.17|
71036455|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.164|||TWO_SIDED|90.0|0.06|0.61||||||Change at Week 2, Left Heel Along Shin Tap||0.61|0.06|
71036456|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.277|||TWO_SIDED|90.0|-0.09|0.84||||||Change at Week 7, Left Heel Along Shin Tap||0.84|-0.09|
71036457|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.234|||TWO_SIDED|90.0|-0.19|0.6||||||Change at Week 7, Left Heel Along Shin Tap||0.60|-0.19|
71036458|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.303|||TWO_SIDED|90.0|-0.2|0.82||||||Change at Week 12, Left Heel Along Shin Tap||0.82|-0.20|
71036459|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.17|0.67||||||Change at Week 12, Left Heel Along Shin Tap||0.67|-0.17|
71036460|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.1|0.5||||||Change at Week 2, Siting Posture||0.5|-0.1|
71036461|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.1|0.4||||||Change at Week 2, Siting Posture||0.4|-0.1|
71036462|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.4|0.2||||||Change at Week 7, Siting Posture||0.2|-0.4|
71036463|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.0|0.5||||||Change at Week 7, Siting Posture||0.5|0.0|
71036464|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.5|0.2||||||Change at Week 12, Siting Posture||0.2|-0.5|
71036465|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|90.0|-0.2|0.3||||||Change at Week 12, Siting Posture||0.3|-0.2|
71036466|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.4|0.4||||||Change at Week 2, SFA - TTA||0.4|-0.4|
71036467|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-0.3|0.3||||||Change at Week 2, SFA - TTA||0.3|-0.3|
71036468|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-0.4|0.2||||||Change at Week 7, SFA - TTA||0.2|-0.4|
71036469|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.5|0.1||||||Change at Week 7, SFA - TTA||0.1|-0.5|
71036470|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|-0.3|0.4||||||Change at Week 12, SFA - TTA||0.4|-0.3|
71036471|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.2|0.4||||||Change at Week 12, SFA - TTA||0.4|-0.2|
71036472|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.1|0.3||||||Change at Week 2, SFA (Eyes Closed) - TTA||0.3|-0.1|
71036473|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 2, SFA (Eyes Closed) - TTA||0.1|-0.2|
71036474|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.4|0.2||||||Change at Week 7, SFA (Eyes Closed) - TTA||0.2|-0.4|
71036475|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|90.0|-0.4|0.1||||||Change at Week 7, SFA (Eyes Closed) - TTA||0.1|-0.4|
71036476|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.3|0.4||||||Change at Week 12, SFA (Eyes Closed) - TTA||0.4|-0.3|
71036477|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.5|0.1||||||Change at Week 12, SFA (Eyes Closed) - TTA||0.1|-0.5|
71036478|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|-0.8|0.2||||||Change at Week 2, SFT - TTA||0.2|-0.8|
71036479|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|0.0|0.8||||||Change at Week 2, SFT - TTA||0.8|0.0|
71097246|NCT02618187|141703469|OTHER|Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks||||||0.384|||||||Wilcoxon (Mann-Whitney)|2-sided||||||0.384
71097247|NCT02618187|141703469|OTHER|Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks||||||0.237|||||||Wilcoxon (Mann-Whitney)|2-sided||||||0.237
71097248|NCT02618187|141703470|SUPERIORITY|Weekly SER-287, after Placebo Pre-Treat. tested against Daily placebo, after Placebo Pre-Treat., for superiority||||||0.257|||||||Wilcoxon (Mann-Whitney)|1-sided||||||0.257
71036480|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.3|0.4||||||Change at Week 7, SFT - TTA||0.4|-0.3|
71036481|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.2|0.7||||||Change at Week 7, SFT - TTA||0.7|0.2|
71036482|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.5|0.2||||||Change at Week 12, SFT - TTA||0.2|-0.5|
71036483|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|0.0|0.7||||||Change at Week 12, SFT - TTA||0.7|0.0|
71036484|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 2, SFT (Eyes Closed) - TTA||0.1|-0.2|
71036485|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 2, SFT (Eyes Closed) - TTA||0.1|-0.2|
71036486|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.2|0.2||||||Change at Week 7, SFT (Eyes Closed) - TTA||0.2|-0.2|
71097249|NCT02618187|141703470|SUPERIORITY|Daily SER-287, After Vanco. Pre-Treat. tested against Daily Placebo, After Placebo Pre-Treat., for superiority||||||0.001|||||||Wilcoxon (Mann-Whitney)|1-sided||||||0.001
71036487|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.1|0.2||||||Change at Week 7, SFT (Eyes Closed) - TTA||0.2|-0.1|
71036488|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.2|0.2||||||Change at Week 12, SFT (Eyes Closed) - TTA||0.2|-0.2|
71036489|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.3|0.0||||||Change at Week 12, SFT (Eyes Closed) - TTA||0.0|-0.3|
71036490|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 2, Tandem Stance - TTA||0.1|-0.2|
71036491|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.1|0.1||||||Change at Week 2, Tandem Stance - TTA||0.1|-0.1|
70922817|NCT04950127|141336686|SUPERIORITY|Fatigue|Mean Difference (Net)|1.59||||0.132|TWO_SIDED|95.0|-0.48|3.67||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.||3.67|-0.48|0.132
71036492|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.2|0.0||||||Change at Week 7, Tandem Stance - TTA||0.0|-0.2|
71036493|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.1|0.2||||||Change at Week 7, Tandem Stance - TTA||0.2|-0.1|
71036494|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 12, Tandem Stance - TTA||0.1|-0.2|
71036495|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.1|0.2||||||Change at Week 12, Tandem Stance - TTA||0.2|-0.1|
71036496|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|90.0|-0.1|0.1||||||Change at Week 2, Tandem Walk||0.1|-0.1|
71036497|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.1|0.1||||||Change at Week 2, Tandem Walk||0.1|-0.1|
71036498|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 7, Tandem Walk||0.1|-0.2|
71036499|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.1|0.1||||||Change at Week 7, Tandem Walk||0.1|-0.1|
71036500|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|-0.3|0.0||||||Change at Week 12, Tandem Walk||0.0|-0.3|
71036501|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 12, Tandem Walk||0.1|-0.2|
71036502|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-0.2|0.4||||||Change at Week 2, Gait||0.4|-0.2|
71036503|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|0.1|0.7||||||Change at Week 2, Gait||0.7|0.1|
71036504|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.4|0.2||||||Change at Week 7, Gait||0.2|-0.4|
71036505|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.1|0.6||||||Change at Week 7, Gait||0.6|0.1|
71097250|NCT02618187|141703470|SUPERIORITY|Weekly SER-287, After Vanco. Pre-Treat. tested against Daily Placebo, After Placebo Pre-Treat., for superiority||||||0.001|||||||Wilcoxon (Mann-Whitney)|1-sided||||||0.001
71097251|NCT02618187|141703470|SUPERIORITY|Weekly SER-287, After Vanco. Pre-Treat. tested against Weekly SER-287, After Placebo Pre-Treat., for superiority||||||0.009|||||||Wilcoxon (Mann-Whitney)|1-sided||||||0.009
71097252|NCT02618187|141703470|SUPERIORITY|Daily SER-287, After Vanco. Pre-Treat., tested against Weekly SER-287, After Vanco. Pre-Treat., for superiority||||||0.168|||||||Wilcoxon (Mann-Whitney)|1-sided||||||0.168
71097253|NCT02618187|141703471|SUPERIORITY||Rate difference (SER-287 - placebo)|13.3||||0.4923|TWO_SIDED|95.0|-3.87|30.54|||Fisher Exact|||||30.54|-3.87|0.4923
71097254|NCT02618187|141703471|SUPERIORITY||Rate difference (SER-287 - placebo)|40.0||||0.0237|TWO_SIDED|95.0|15.21|64.79|||Fisher Exact|||||64.79|15.21|0.0237
70982383|NCT01982630|141473141|OTHER||Difference of Least Squares Means|-6.25|||||TWO_SIDED|90.0|-10.48|-2.01|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||-2.01|-10.48|
70982384|NCT01982630|141473141|OTHER||Difference of Least Squares Means|6.02|||||TWO_SIDED|90.0|1.81|10.22|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||10.22|1.81|
70982385|NCT01982630|141473141|OTHER||Difference of Least Squares Means|1.5|||||TWO_SIDED|90.0|-2.65|5.64|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||5.64|-2.65|
70982386|NCT01982630|141473141|OTHER||Difference of Least Squares Means|-4.52|||||TWO_SIDED|90.0|-8.52|-0.52|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||-0.52|-8.52|
70982387|NCT01982630|141473141|OTHER||Difference of Least Squares Means|1.73|||||TWO_SIDED|90.0|-2.38|5.83|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||5.83|-2.38|
71036506|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.4|0.2||||||Change at Week 12, Gait||0.2|-0.4|
71036507|NCT03214588|141581557|SUPERIORITY||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|90.0|0.0|0.5||||||Change at Week 12, Gait||0.5|0.0|
71036508|NCT03214588|141581558|SUPERIORITY||Least Squares Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.889||0.599|TWO_SIDED|90.0|-1.31|1.76||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||1.76|-1.31|0.599
71036509|NCT03214588|141581558|SUPERIORITY||Least Squares Mean Difference|1.34|STANDARD_ERROR_OF_MEAN|0.625||0.978|TWO_SIDED|90.0|0.26|2.42||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||2.42|0.26|0.978
71097255|NCT02618187|141703471|SUPERIORITY||Rate difference (SER-287 - placebo)|17.6||||0.2579|TWO_SIDED|95.0|-0.47|35.77|||Fisher Exact|||||35.77|-0.47|0.2579
71097256|NCT02618187|141703472|SUPERIORITY||Rate difference (SER-287 - placebo)|24.2||||0.1973|TWO_SIDED|95.0|-5.04|53.53|||Fisher Exact|||||53.53|-5.04|0.1973
71097257|NCT02618187|141703472|SUPERIORITY||Rate difference (SER-287 - placebo)|30.9||||0.1783|TWO_SIDED|95.0|0.86|60.96|||Fisher Exact|||||60.96|0.86|0.1783
71097258|NCT02618187|141703472|SUPERIORITY||Rate difference (SER-287 - placebo)|14.4||||0.6195|TWO_SIDED|95.0|-11.93|40.81|||Fisher Exact|||||40.81|-11.93|0.6195
71097259|NCT02362412|141703555|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.5|||||TWO_SIDED|95.0|-3.4|2.3||p-value was not adjusted|||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.|||2.3|-3.4|
71097260|NCT02362412|141703556|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.1|||||TWO_SIDED|95.0|-1.7|1.9|||||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.|||1.9|-1.7|
71097261|NCT02362412|141703557|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.1|||||TWO_SIDED|95.0|-0.3|0.4|||||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.|||0.4|-0.3|
71097262|NCT02362412|141703558|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.1|||||TWO_SIDED|95.0|-0.3|0.4|||||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.|||0.4|-0.3|
71097263|NCT02362412|141703560|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.0|||||TWO_SIDED|95.0|-0.5|0.5|||||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.|||0.5|-0.5|
71097264|NCT02362412|141703561|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.0|||||TWO_SIDED|95.0|-0.5|0.5|||||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.|||0.5|-0.5|
71097265|NCT05103332|141703570|SUPERIORITY||Difference in LS Mean|-12.1|STANDARD_ERROR_OF_MEAN|2.24|<|0.0001|TWO_SIDED|95.0|-16.5|-7.6||MMRM: Fixed factors: treatment, visit, treatment-by-visit interaction, race (black/all other races); Covariates: Baseline (BA) 24-hour mean SBP using ABPM \& BA estimated glomerular filtration rate (eGFR). Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to indapamide) and placebo (add on to indapamide), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort \& handle primary \& key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \< 0.05. Data for SBP, assessed using ABPM, while participants were on \& within 2 weeks after stopping any escape medication were censored for this endpoint.||-7.6|-16.5|<0.0001
70982388|NCT01982630|141473142|OTHER||Difference of Least Squares Means|-2.11|||||TWO_SIDED|90.0|-4.55|0.32|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||0.32|-4.55|
70982389|NCT01982630|141473142|OTHER||Difference of Least Squares Means|2.53|||||TWO_SIDED|90.0|-0.61|5.66|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||5.66|-0.61|
70982390|NCT01982630|141473142|OTHER||Difference of Least Squares Means|4.64|||||TWO_SIDED|90.0|1.35|7.93|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||7.93|1.35|
70982391|NCT01982630|141473143|OTHER||Difference of Least Squares Means|-0.65|||||TWO_SIDED|90.0|-5.01|3.71|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||3.71|-5.01|
70982392|NCT01982630|141473143|OTHER||Difference of Least Squares Means|-6.42|||||TWO_SIDED|90.0|-10.66|-2.19|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||-2.19|-10.66|
70982393|NCT01982630|141473143|OTHER||Difference of Least Squares Means|5.77|||||TWO_SIDED|90.0|1.57|9.97|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||9.97|1.57|
70982394|NCT01982630|141473143|OTHER||Difference of Least Squares Means|-0.15|||||TWO_SIDED|90.0|-4.29|4.0|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||4.00|-4.29|
70982395|NCT01982630|141473143|OTHER||Difference of Least Squares Means|-5.91|||||TWO_SIDED|90.0|-9.91|-1.92|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||-1.92|-9.91|
70982396|NCT01982630|141473143|OTHER||Difference of Least Squares Means|0.51|||||TWO_SIDED|90.0|-3.6|4.62|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||4.62|-3.60|
70982397|NCT01982630|141473144|OTHER||Difference of Least Squares Means|-0.89|||||TWO_SIDED|90.0|-3.8|2.02|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||2.02|-3.80|
70982398|NCT01982630|141473144|OTHER||Difference of Least Squares Means|5.24|||||TWO_SIDED|90.0|1.34|9.15|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||9.15|1.34|
70982399|NCT01982630|141473144|OTHER||Difference of Least Squares Means|6.13|||||TWO_SIDED|90.0|2.05|10.22|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||10.22|2.05|
70982400|NCT01982630|141473145|OTHER||Difference of Least Squares Means|-0.57|||||TWO_SIDED|90.0|-3.71|2.57|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||2.57|-3.71|
70982401|NCT01982630|141473145|OTHER||Difference of Least Squares Means|7.77|||||TWO_SIDED|90.0|3.5|12.03|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||12.03|3.50|
70982402|NCT01982630|141473145|OTHER||Difference of Least Squares Means|8.34|||||TWO_SIDED|90.0|3.89|12.79|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||12.79|3.89|
70982403|NCT01982630|141473146|OTHER||Difference of Least Squares Means|1.35|||||TWO_SIDED|90.0|-2.4|5.09|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||5.09|-2.40|
70982404|NCT01982630|141473146|OTHER||Difference of Least Squares Means|8.29|||||TWO_SIDED|90.0|3.29|13.3|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||13.30|3.29|
70982405|NCT01982630|141473146|OTHER||Difference of Least Squares Means|6.95|||||TWO_SIDED|90.0|1.69|12.2|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||12.20|1.69|
70982406|NCT01982630|141473147|OTHER||Difference of Least Squares Means|2.46|||||TWO_SIDED|90.0|-1.42|6.34|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||6.34|-1.42|
70982407|NCT01982630|141473147|OTHER||Difference of Least Squares Means|9.61|||||TWO_SIDED|90.0|4.42|14.81|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||14.81|4.42|
70982408|NCT01982630|141473147|OTHER||Difference of Least Squares Means|7.15|||||TWO_SIDED|90.0|1.7|12.6|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||12.60|1.70|
70982409|NCT01982630|141473148|OTHER||Difference of Least Squares Means|-3.97|||||TWO_SIDED|90.0|-6.8|-1.14|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||-1.14|-6.80|
70982410|NCT01982630|141473148|OTHER||Difference of Least Squares Means|-0.7|||||TWO_SIDED|90.0|-4.33|2.93|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||2.93|-4.33|
70982411|NCT01982630|141473148|OTHER||Difference of Least Squares Means|3.26|||||TWO_SIDED|90.0|-0.54|7.06|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||7.06|-0.54|
70982412|NCT01982630|141473149|OTHER||Difference of Least Squares Means|-1.58|||||TWO_SIDED|90.0|-5.31|2.15|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||2.15|-5.31|
70982413|NCT01982630|141473149|OTHER||Difference of Least Squares Means|2.52|||||TWO_SIDED|90.0|-2.32|7.35|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||7.35|-2.32|
70982414|NCT01982630|141473149|OTHER||Difference of Least Squares Means|4.1|||||TWO_SIDED|90.0|-0.96|9.16|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||9.16|-0.96|
70982415|NCT01982630|141473150|OTHER||Difference of Least Squares Means|-3.48|||||TWO_SIDED|90.0|-7.31|0.34|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||0.34|-7.31|
70982416|NCT01982630|141473150|OTHER||Difference of Least Squares Means|3.96|||||TWO_SIDED|90.0|-1.11|9.03|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||9.03|-1.11|
70982417|NCT01982630|141473150|OTHER||Difference of Least Squares Means|7.44|||||TWO_SIDED|90.0|2.16|12.73|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||12.73|2.16|
70982418|NCT01982630|141473151|OTHER||Difference of Least Squares Means|0.03|||||TWO_SIDED|90.0|-4.51|4.57|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||4.57|-4.51|
70982419|NCT01982630|141473151|OTHER||Difference of Least Squares Means|4.7|||||TWO_SIDED|90.0|-1.33|10.73|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||10.73|-1.33|
70982420|NCT01982630|141473151|OTHER||Difference of Least Squares Means|4.66|||||TWO_SIDED|90.0|-1.67|11.0|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||11.00|-1.67|
70982421|NCT01982630|141473152|OTHER||Difference of Least Squares Means|3.34|||||TWO_SIDED|90.0|-0.7|7.39|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||7.39|-0.70|
70982422|NCT01982630|141473152|OTHER||Difference of Least Squares Means|8.88|||||TWO_SIDED|90.0|3.53|14.23|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||14.23|3.53|
70982423|NCT01982630|141473152|OTHER||Difference of Least Squares Means|5.54|||||TWO_SIDED|90.0|-0.08|11.15|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||11.15|-0.08|
70982424|NCT01982630|141473153|OTHER||Difference of Least Squares Means|-3.55|||||TWO_SIDED|90.0|-6.98|-0.12|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||-0.12|-6.98|
70982425|NCT01982630|141473153|OTHER||Difference of Least Squares Means|1.05|||||TWO_SIDED|90.0|-3.38|5.49|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||5.49|-3.38|
70982426|NCT01982630|141473153|OTHER||Difference of Least Squares Means|4.61|||||TWO_SIDED|90.0|-0.02|9.23|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||9.23|-0.02|
70982427|NCT01982630|141473154|OTHER||Difference of Least Squares Means|-1.16|||||TWO_SIDED|90.0|-4.59|2.28|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||2.28|-4.59|
70982428|NCT01982630|141473154|OTHER||Difference of Least Squares Means|8.65|||||TWO_SIDED|90.0|3.99|13.31|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||13.31|3.99|
70982429|NCT01982630|141473154|OTHER||Difference of Least Squares Means|9.8|||||TWO_SIDED|90.0|4.96|14.65|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||14.65|4.96|
70982430|NCT01982630|141473155|OTHER||Difference of Least Squares Means|-4.04|||||TWO_SIDED|90.0|-7.52|-0.56|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||-0.56|-7.52|
70982431|NCT01982630|141473155|OTHER||Difference of Least Squares Means|10.23|||||TWO_SIDED|90.0|5.57|14.89|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||14.89|5.57|
70982432|NCT01982630|141473155|OTHER||Difference of Least Squares Means|14.27|||||TWO_SIDED|90.0|9.38|19.15|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||19.15|9.38|
70982433|NCT01982630|141473156|OTHER||Difference of Least Squares Means|-2.12|||||TWO_SIDED|90.0|-5.7|1.47|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||1.47|-5.70|
70982434|NCT01982630|141473156|OTHER||Difference of Least Squares Means|13.34|||||TWO_SIDED|90.0|8.64|18.03|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||18.03|8.64|
70982435|NCT01982630|141473156|OTHER||Difference of Least Squares Means|15.45|||||TWO_SIDED|90.0|10.53|20.38|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||20.38|10.53|
70982436|NCT01982630|141473157|OTHER||Difference of Least Squares Means|2.11|||||TWO_SIDED|90.0|-1.47|5.7|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||5.70|-1.47|
71036510|NCT03214588|141581558|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|1.14||0.533|TWO_SIDED|90.0|-1.87|2.06||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||2.06|-1.87|0.533
71036511|NCT03214588|141581558|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.886||0.37|TWO_SIDED|90.0|-1.83|1.23||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||1.23|-1.83|0.370
71036512|NCT03214588|141581558|SUPERIORITY||Least Squares Mean Difference|2.18|STANDARD_ERROR_OF_MEAN|1.078||0.972|TWO_SIDED|90.0|0.32|4.04||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||4.04|0.32|0.972
71036513|NCT03214588|141581558|SUPERIORITY||Least Squares Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|0.819||0.825|TWO_SIDED|90.0|-0.63|2.19||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||2.19|-0.63|0.825
71036514|NCT03214588|141581559|SUPERIORITY||Least Squares Mean Difference|0.045|STANDARD_ERROR_OF_MEAN|0.23858||0.426|TWO_SIDED|90.0|-0.3665|0.4565||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||0.4565|-0.3665|0.426
71036515|NCT03214588|141581559|SUPERIORITY||Least Squares Mean Difference|-0.3281|STANDARD_ERROR_OF_MEAN|0.15794||0.975|TWO_SIDED|90.0|-0.6005|-0.0557||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||-0.0557|-0.6005|0.975
71036516|NCT03214588|141581559|SUPERIORITY||Least Squares Mean Difference|0.1448|STANDARD_ERROR_OF_MEAN|0.31186||0.324|TWO_SIDED|90.0|-0.3931|0.6826||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||0.6826|-0.3931|0.324
71036517|NCT03214588|141581559|SUPERIORITY||Least Squares Mean Difference|0.0113|STANDARD_ERROR_OF_MEAN|0.23213||0.481|TWO_SIDED|90.0|-0.3891|0.4117||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||0.4117|-0.3891|0.481
71036518|NCT03214588|141581559|SUPERIORITY||Least Squares Mean Difference|-0.2067|STANDARD_ERROR_OF_MEAN|0.28088||0.765|TWO_SIDED|90.0|-0.6911|0.2778||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||0.2778|-0.6911|0.765
71036519|NCT03214588|141581559|SUPERIORITY||Least Squares Mean Difference|0.1173|STANDARD_ERROR_OF_MEAN|0.19778||0.28|TWO_SIDED|90.0|-0.2238|0.4585||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||0.4585|-0.2238|0.280
71097266|NCT05103332|141703571|SUPERIORITY||Difference in LS Mean|-9.7|STANDARD_ERROR_OF_MEAN|1.61|<|0.0001|TWO_SIDED|95.0|-12.9|-6.6||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to amlodipine) and placebo (add on to amlodipine), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort \& handle primary \& key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \< 0.05. Data for SBP, assessed using ABPM, while participants were on \& within 2 weeks after stopping any escape medication were censored for this endpoint.||-6.6|-12.9|<0.0001
71036520|NCT03214588|141581560|SUPERIORITY||Least Squares Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|4.28||0.735|TWO_SIDED|90.0|-9.9|4.4||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||4.4|-9.9|0.735
71036521|NCT03214588|141581560|SUPERIORITY||Least Squares Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|3.51||0.182|TWO_SIDED|90.0|-2.7|9.1||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||9.1|-2.7|0.182
71036522|NCT03214588|141581560|SUPERIORITY||Least Squares Mean Difference|-6.9|STANDARD_ERROR_OF_MEAN|3.59||0.97|TWO_SIDED|90.0|-12.9|-0.9||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||-0.9|-12.9|0.970
71036523|NCT03214588|141581560|SUPERIORITY||Least Squares Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|3.0||0.321|TWO_SIDED|90.0|-3.6|6.4||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||6.4|-3.6|0.321
71036524|NCT03214588|141581560|SUPERIORITY||Least Squares Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|4.34||0.905|TWO_SIDED|90.0|-13.0|1.5||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||1.5|-13.0|0.905
71036525|NCT03214588|141581560|SUPERIORITY||Least Squares Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|3.57||0.199|TWO_SIDED|90.0|-2.9|9.0||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||9.0|-2.9|0.199
71036526|NCT03214588|141581561|SUPERIORITY|||||||0.974||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.974
71036527|NCT03214588|141581561|SUPERIORITY|||||||0.893||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.893
71036528|NCT03214588|141581561|SUPERIORITY|||||||0.954||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.954
71036529|NCT03214588|141581561|SUPERIORITY|||||||0.793||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.793
71036530|NCT03214588|141581561|SUPERIORITY|||||||0.845||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.845
71036531|NCT03214588|141581561|SUPERIORITY|||||||0.816||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.816
71036532|NCT03214588|141581562|SUPERIORITY|||||||0.84||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.840
71036533|NCT03214588|141581562|SUPERIORITY|||||||0.854||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.854
71036534|NCT03214588|141581562|SUPERIORITY|||||||0.922||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.922
71097267|NCT05103332|141703572|SUPERIORITY||Difference in LS Mean|-4.5|STANDARD_ERROR_OF_MEAN|1.89|=|0.0183|TWO_SIDED|95.0|-8.2|-0.8||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to olmesartan) and placebo (add on to olmesartan), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort \& handle primary \& key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \< 0.05. Data for SBP, assessed using ABPM, while participants were on \& within 2 weeks after stopping any escape medication were censored for this endpoint.||-0.8|-8.2|=0.0183
71097268|NCT05103332|141703573|SUPERIORITY||Difference in LS Mean|-18.5|STANDARD_ERROR_OF_MEAN|2.17|<|0.0001|TWO_SIDED|95.0|-22.8|-14.2||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to indapamide) and placebo (add on to indapamide), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \< 0.05. Data for office SBP assessed while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.||-14.2|-22.8|<0.0001
71036535|NCT03214588|141581562|SUPERIORITY|||||||0.794||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.794
71036536|NCT03214588|141581562|SUPERIORITY|||||||0.83||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.830
71036537|NCT03214588|141581562|SUPERIORITY|||||||0.998||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.998
71036538|NCT03214588|141581563|SUPERIORITY|||||||0.987||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.987
71036539|NCT03214588|141581563|SUPERIORITY|||||||0.771||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.771
71036540|NCT03214588|141581563|SUPERIORITY|||||||0.526||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.526
71036541|NCT03214588|141581563|SUPERIORITY|||||||0.665||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.665
71036542|NCT03214588|141581563|SUPERIORITY|||||||0.576||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.576
71036543|NCT03214588|141581563|SUPERIORITY|||||||0.865||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.865
71036544|NCT03214588|141581564|SUPERIORITY|||||||0.966||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.966
71036545|NCT03214588|141581564|SUPERIORITY|||||||0.983||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.983
71036546|NCT03214588|141581564|SUPERIORITY|||||||0.953||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.953
71036547|NCT03214588|141581564|SUPERIORITY|||||||0.781||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.781
70982437|NCT01982630|141473157|OTHER||Difference of Least Squares Means|10.43|||||TWO_SIDED|90.0|5.73|15.13|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||15.13|5.73|
70982438|NCT01982630|141473157|OTHER||Difference of Least Squares Means|8.32|||||TWO_SIDED|90.0|3.4|13.24|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||13.24|3.40|
70982439|NCT01982630|141473173|OTHER||Difference of Least Squares Means|29.56|||||TWO_SIDED|90.0|4.34|54.77|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||54.77|4.34|
70982440|NCT01982630|141473173|OTHER||Difference of Least Squares Means|26.1|||||TWO_SIDED|90.0|2.02|50.19|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||50.19|2.02|
70982441|NCT01982630|141473173|OTHER||Difference of Least Squares Means|3.45|||||TWO_SIDED|90.0|-20.23|27.14|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||27.14|-20.23|
70982442|NCT01982630|141473173|OTHER||Difference of Least Squares Means|-26.45|||||TWO_SIDED|90.0|-49.96|-2.93|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-2.93|-49.96|
70982443|NCT01982630|141473173|OTHER||Difference of Least Squares Means|-29.9|||||TWO_SIDED|90.0|-52.04|-7.77|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-7.77|-52.04|
70982444|NCT01982630|141473173|OTHER||Difference of Least Squares Means|-56.0|||||TWO_SIDED|90.0|-79.53|-32.48|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-32.48|-79.53|
70982445|NCT01982630|141473174|OTHER||Difference of Least Squares Means|14.96|||||TWO_SIDED|90.0|-10.25|40.18|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||40.18|-10.25|
71036548|NCT03214588|141581564|SUPERIORITY|||||||0.948||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.948
70982446|NCT01982630|141473174|OTHER||Difference of Least Squares Means|6.57|||||TWO_SIDED|90.0|-17.52|30.65|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||30.65|-17.52|
70982447|NCT01982630|141473174|OTHER||Difference of Least Squares Means|8.4|||||TWO_SIDED|90.0|-15.29|32.08|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||32.08|-15.29|
71036549|NCT03214588|141581564|SUPERIORITY|||||||0.998||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.998
70982448|NCT01982630|141473174|OTHER||Difference of Least Squares Means|-35.23|||||TWO_SIDED|90.0|-58.75|-11.72|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-11.72|-58.75|
70982449|NCT01982630|141473174|OTHER||Difference of Least Squares Means|-43.63|||||TWO_SIDED|90.0|-65.77|-21.5|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-21.50|-65.77|
70982450|NCT01982630|141473174|OTHER||Difference of Least Squares Means|-50.2|||||TWO_SIDED|90.0|-73.72|-26.68|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-26.68|-73.72|
70982451|NCT01982630|141473175|OTHER||Difference of Least Squares Means|-31.2|||||TWO_SIDED|90.0|-56.59|-5.81|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||-5.81|-56.59|
70982452|NCT01982630|141473175|OTHER||Difference of Least Squares Means|-25.12|||||TWO_SIDED|90.0|-50.25|0.01|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||0.01|-50.25|
70982453|NCT01982630|141473175|OTHER||Difference of Least Squares Means|-6.08|||||TWO_SIDED|90.0|-17.31|5.14|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||5.14|-17.31|
70982454|NCT01982630|141473176|OTHER||Difference of Least Squares Means|-27.48|||||TWO_SIDED|90.0|-52.87|-2.09|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||-2.09|-52.87|
70982455|NCT01982630|141473176|OTHER||Difference of Least Squares Means|-30.59|||||TWO_SIDED|90.0|-55.72|-5.46|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||-5.46|-55.72|
70982456|NCT01982630|141473176|OTHER||Difference of Least Squares Means|3.11|||||TWO_SIDED|90.0|-8.11|14.34|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||14.34|-8.11|
71036550|NCT03214588|141581565|SUPERIORITY|||||||0.666||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.666
71036551|NCT03214588|141581565|SUPERIORITY|||||||0.812||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.812
71036552|NCT03214588|141581565|SUPERIORITY|||||||0.834||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.834
71036553|NCT03214588|141581565|SUPERIORITY|||||||0.841||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.841
71036554|NCT03214588|141581565|SUPERIORITY|||||||0.893||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.893
70982457|NCT01982630|141473177|OTHER||Difference of Least Squares Means|4.59|||||TWO_SIDED|90.0|-20.88|30.06|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||30.06|-20.88|
71036555|NCT03214588|141581565|SUPERIORITY|||||||0.907||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.907
71036556|NCT03214588|141581566|SUPERIORITY|||||||0.032||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.032
71036557|NCT03214588|141581566|SUPERIORITY|||||||0.216||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.216
71036558|NCT03214588|141581566|SUPERIORITY|||||||0.215||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.215
70982458|NCT01982630|141473177|OTHER||Difference of Least Squares Means|-5.42|||||TWO_SIDED|90.0|-30.68|19.85|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||19.85|-30.68|
70982459|NCT01982630|141473177|OTHER||Difference of Least Squares Means|10.01|||||TWO_SIDED|90.0|-1.77|21.78|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||21.78|-1.77|
70982460|NCT01982630|141473178|OTHER||Difference of Least Squares Means|-14.98|||||TWO_SIDED|90.0|-40.53|10.57|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||10.57|-40.53|
70982461|NCT01982630|141473178|OTHER||Difference of Least Squares Means|-14.5|||||TWO_SIDED|90.0|-39.77|10.76|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||10.76|-39.77|
70982462|NCT01982630|141473178|OTHER||Difference of Least Squares Means|-0.48|||||TWO_SIDED|90.0|-12.47|11.52|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||11.52|-12.47|
70982463|NCT01982630|141473179|OTHER||Difference of Least Squares Means|-43.68|||||TWO_SIDED|90.0|-65.81|-21.55|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-21.55|-65.81|
70982464|NCT01982630|141473179|OTHER||Difference of Least Squares Means|-47.4|||||TWO_SIDED|90.0|-69.35|-25.45|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-25.45|-69.35|
70982465|NCT01982630|141473179|OTHER||Difference of Least Squares Means|3.72|||||TWO_SIDED|90.0|-5.76|13.19|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||13.19|-5.76|
70982466|NCT01982630|141473180|OTHER||Difference of Least Squares Means|-34.01|||||TWO_SIDED|90.0|-56.14|-11.88|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-11.88|-56.14|
71036559|NCT03214588|141581566|SUPERIORITY|||||||0.411||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.411
71036560|NCT03214588|141581566|SUPERIORITY|||||||0.194||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.194
71036561|NCT03214588|141581566|SUPERIORITY|||||||0.408||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.408
70982467|NCT01982630|141473180|OTHER||Difference of Least Squares Means|-39.2|||||TWO_SIDED|90.0|-61.15|-17.26|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-17.26|-61.15|
70982468|NCT01982630|141473180|OTHER||Difference of Least Squares Means|5.2|||||TWO_SIDED|90.0|-4.28|14.67|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||14.67|-4.28|
71036562|NCT03214588|141581567|SUPERIORITY|||||||0.406||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.406
71036563|NCT03214588|141581567|SUPERIORITY|||||||0.235||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.235
71036564|NCT03214588|141581567|SUPERIORITY|||||||0.225||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.225
71036565|NCT03214588|141581567|SUPERIORITY|||||||0.434||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.434
71036566|NCT03214588|141581567|SUPERIORITY|||||||0.249||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.249
71036567|NCT03214588|141581567|SUPERIORITY|||||||0.38||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.380
71036568|NCT03214588|141581568|SUPERIORITY|||||||0.422||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.422
70982469|NCT01982630|141473181|OTHER||Difference of Least Squares Means|-23.73|||||TWO_SIDED|90.0|-45.89|-1.56|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-1.56|-45.89|
70982470|NCT01982630|141473181|OTHER||Difference of Least Squares Means|-33.95|||||TWO_SIDED|90.0|-55.93|-11.98|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-11.98|-55.93|
70982471|NCT01982630|141473181|OTHER||Difference of Least Squares Means|10.23|||||TWO_SIDED|90.0|0.56|19.89|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||19.89|0.56|
70982472|NCT01982630|141473182|OTHER||Difference of Least Squares Means|-23.49|||||TWO_SIDED|90.0|-45.65|-1.32|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-1.32|-45.65|
70982473|NCT01982630|141473182|OTHER||Difference of Least Squares Means|-29.76|||||TWO_SIDED|90.0|-51.74|-7.79|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-7.79|-51.74|
70982474|NCT01982630|141473182|OTHER||Difference of Least Squares Means|6.27|||||TWO_SIDED|90.0|-3.39|15.93|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||15.93|-3.39|
70982475|NCT01273818|141473198|SUPERIORITY_OR_OTHER||Fscher exact test|||||0.198|TWO_SIDED||||||Fisher Exact||we did not need an estimation parameter such as odds or relative risk because of our experimental design and hypothesis of this study.|"Comparison Group Selection: our primary outcome is infection positive or negativeso, we compared the frequencies of being positive infections for these three groups. Our null hypothesis is  positive infection frequencies are same for three groups. We calculated post-hoc power for this design and found 0.99 for the percentages which shows positive infections respectively for Topical Gentamicin, cefazoline iv and topical gentamicin and iv cefazolin; 2.3%, 3.1% and 0%."||||0.198
71036569|NCT03214588|141581568|SUPERIORITY|||||||0.226||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.226
70982476|NCT03815175|141473199|NON_INFERIORITY|"H0: Death/(MI\[1m-DAPT\]) - Death/(MI \[XIENCE V USA\]) ≥ δ HA: Death/MI(\[1m-DAPT\]) - Death/(MI \[XIENCE V USA: NCT00676520\]) \< δ~Where δ is the non-inferiority margin. The test will be carried out with a one-sided significance level of 0.025 and a non-inferiority margin (δ) of 2.5%."||||||0.0005|||||||Farrington-Manning method|||||||0.0005
70982477|NCT03815175|141473202|SUPERIORITY|"H0: B (1m-DAPT) - B (XIENCE V USA) ≥ 0 HA: B (1m-DAPT) - B (XIENCE V USA: NCT00676520) \< 0~B 1m-DAPT and B XIENCE V USA are bleeding rates (BARC type 2-5) between 1-month and 6-month follow-up for the pooled 1-month DAPT arm and XIENCE V USA historical control, respectively."||||||0.1888|||||||Farrington and Manning method|||||||0.1888
70982478|NCT02513446|141473277|SUPERIORITY_OR_OTHER||Adjusted gMean T/R ratio|176.1|||||TWO_SIDED|90.0|160.5|193.2|||ANOVA|Analysis of variance (ANOVA) on the logarithmic scale; Fixed effects: sequence, period and treatment; Random effects: subjects within sequences|Ratio of the treatment adjusted geometric means (gMean) of (T) versus (R).|||193.2|160.5|
70982479|NCT02513446|141473278|SUPERIORITY_OR_OTHER||Adjusted gMean T/R ratio|136.5|||||TWO_SIDED|90.0|109.9|169.4|||ANOVA|Analysis of variance (ANOVA) on the logarithmic scale; Fixed effects: sequence, period and treatment; Random effects: subjects within sequences|Ratio of the treatment adjusted geometric means (gMean) of (T) versus (R).|||169.4|109.9|
70982480|NCT02513446|141473279|SUPERIORITY_OR_OTHER||Adjusted gMean T/R ratio|174.8|||||TWO_SIDED|90.0|159.1|192.0|||ANOVA|Analysis of variance (ANOVA) on the logarithmic scale; Fixed effects: sequence, period and treatment; Random effects: subjects within sequences|Ratio of the treatment adjusted geometric means (gMean) of (T) versus (R).|||192.0|159.1|
70982481|NCT05300087|141473298|EQUIVALENCE|Bioequivalence would be demonstrated if the 90% confidence interval for the ratio of geometric means for Cmax between the test and reference products were completely contained within the FDA defined acceptance range of 80.00%-125.00%.|Ratio of geometric least square mean|1.014|||<|0.0001|TWO_SIDED|90.0|0.947|1.085|||ANOVA|||||1.085|0.947|<0.0001
71036570|NCT03214588|141581568|SUPERIORITY|||||||0.639||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.639
71036571|NCT03214588|141581568|SUPERIORITY|||||||0.094||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.094
71036572|NCT03214588|141581568|SUPERIORITY|||||||0.516||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.516
71036573|NCT03214588|141581568|SUPERIORITY|||||||0.266||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.266
71036574|NCT03214588|141581569|SUPERIORITY||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.362||0.299|TWO_SIDED|90.0|-0.8|0.41||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||0.41|-0.80|0.299
70982482|NCT05300087|141473299|EQUIVALENCE|Bioequivalence would be demonstrated if the 90% confidence interval for the ratio of geometric means for AUC(0-t) between the test and reference products were completely contained within the FDA defined acceptance range of 80.00%-125.00%.|Ratio of geometric least square mean|1.022|||<|0.0001|TWO_SIDED|90.0|0.993|1.051|||ANOVA|||||1.051|0.993|<0.0001
70982483|NCT05300087|141473300|EQUIVALENCE|Bioequivalence would be demonstrated if the 90% confidence interval for the ratio of geometric means for AUC(0-inf) between the test and reference products were completely contained within the FDA defined acceptance range of 80.00%-125.00%.|Ratio of geometric least square mean|1.021|||<|0.0001|TWO_SIDED|90.0|0.994|1.048|||ANOVA|||||1.048|0.994|<0.0001
70982484|NCT03248128|141473305|SUPERIORITY||Least Square Mean Difference|0.083|||<|0.001|TWO_SIDED|95.0|0.037|0.129|||ANCOVA|Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||0.129|0.037|<0.001
70982485|NCT03248128|141473306|SUPERIORITY||Least Square Mean Difference|3.2||||0.228|TWO_SIDED|95.0|-2.0|8.4|||ANCOVA|Analysis was performed using analysis of covariance (ANCOVA) with covariates of baseline, region, sex, age and treatment.||||8.4|-2.0|0.228
71097269|NCT05103332|141703574|SUPERIORITY||Difference in LS Mean|-11.0|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|-14.7|-7.3||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to indapamide) and placebo (add on to indapamide), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05. All collected data for SBP assessed by ABPM, were included in the analysis for this endpoint.||-7.3|-14.7|<0.0001
71097270|NCT05103332|141703575|SUPERIORITY||Difference in LS Mean|-13.6|STANDARD_ERROR_OF_MEAN|1.66|<|0.0001|TWO_SIDED|95.0|-16.9|-10.3||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to indapamide) and placebo (add on to indapamide), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05. All collected data for office SBP were included in the analysis for this endpoint.||-10.3|-16.9|<0.0001
71097271|NCT05103332|141703576|SUPERIORITY||Odds Ratio (OR)|12.39|||<|0.0001|TWO_SIDED|95.0|4.61|33.29||Logistic regression model included treatment and race (black or all other races) as factors and baseline 24-hour mean SBP and baseline eGFR as covariates.|Regression, Logistic|||A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05.||33.29|4.61|<0.0001
71097272|NCT05103332|141703587|SUPERIORITY||Difference in LS Mean|-10.2|STANDARD_ERROR_OF_MEAN|1.67|<|0.0001|TWO_SIDED|95.0|-13.4|-6.9||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to amlodipine) and placebo (add on to amlodipine), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \< 0.05. Data for office SBP assessed while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.||-6.9|-13.4|<0.0001
70982486|NCT03248128|141473307|SUPERIORITY||Least Square Mean Difference|6.2||||0.011|TWO_SIDED|95.0|1.4|10.9|||ANCOVA|Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||10.9|1.4|0.011
70982487|NCT03248128|141473308|SUPERIORITY||Least Square Mean Difference|0.073||||0.002|TWO_SIDED|95.0|0.028|0.118|||ANCOVA|Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||0.118|0.028|0.002
70982488|NCT03248128|141473309|SUPERIORITY||Least Square Mean Difference|-0.3||||0.87|TWO_SIDED|95.0|-4.5|3.8|||ANCOVA|Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||3.8|-4.5|0.870
70982489|NCT03248128|141473310|SUPERIORITY||Least Square Mean Difference|0.0||||0.988|TWO_SIDED|95.0|-4.2|4.1|||ANCOVA|Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||4.1|-4.2|0.988
70982490|NCT03248128|141473311|SUPERIORITY||Least Square Mean Difference|0.035||||0.124|TWO_SIDED|0.95|-0.01|0.08|||Repeated measures analysis|||Analysis was performed using a repeated measures analysis adjusted for baseline, region, sex, age, treatment, visit, visit by baseline interaction and visit by treatment group interaction.||0.080|-0.010|0.124
70982491|NCT03248128|141473312|SUPERIORITY||Least Square Mean Difference|-0.01||||0.91|TWO_SIDED|95.0|-0.1|0.09|||Repeated measures analysis|||Analysis was performed using a repeated measures analysis adjusted for baseline, region, sex, age, treatment, visit, visit by baseline interaction and visit by treatment group interaction.||0.09|-0.10|0.910
70982492|NCT03248128|141473313|SUPERIORITY||Least Square Mean Difference|1.3||||0.614|TWO_SIDED|95.0|-3.6|6.2|||ANCOVA|Analysis performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||6.2|-3.6|0.614
70982493|NCT03248128|141473314|SUPERIORITY||Least Square Mean Difference|1.3||||0.594|TWO_SIDED|95.0|-3.6|6.3|||ANCOVA|Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||6.3|-3.6|0.594
70982494|NCT03248128|141473315|SUPERIORITY||Least Square Mean Difference|0.028||||0.226|TWO_SIDED|95.0|-0.017|0.073|||Repeated measures analysis|||Analysis was performed using a repeated measures analysis adjusted for baseline, region, sex, age, treatment, visit, visit by baseline interaction and visit by treatment group interaction.||0.073|-0.017|0.226
70982495|NCT03248128|141473316|SUPERIORITY||Least Square Mean Difference|-0.02||||0.663|TWO_SIDED|95.0|-0.13|0.09|||Repeated measures analysis|||Analysis was performed using a repeated measures analysis adjusted for baseline, region, sex, age, treatment, visit, visit by baseline interaction and visit by treatment group interaction.||0.09|-0.13|0.663
70982496|NCT00002850|141473338|SUPERIORITY_OR_OTHER|||||||0.218|||||||Fisher Exact|Target accrual=70 patients per arm to provide 92% power to detect a difference of 0.31 vs. 0.08 in the proportion of patients with serious infection.||"H0: There is no significant difference in the incidence of severe bacterial infections among all three arms during the first 2 months of treatment at the two-sided 0.05 significance level.~Ha: There is a significant difference in the incidence of severe bacterial infections among all three arms during the first 2 months of treatment at the two-sided 0.05 significance level."||||0.218
70982497|NCT05635838|141473346|SUPERIORITY|Response Variable = Treatment + Baseline AN Count Category (≥3 to 4, ≥5 to 10) + Visit + Treatment\*Visit|least squares mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.506||0.0215|TWO_SIDED|95.0|-2.21|-0.18|||ANCOVA|||||-0.18|-2.21|0.0215
70982498|NCT05635838|141473348|SUPERIORITY|Response Variable = Treatment + Baseline AN Count Category (≥3 to 4, ≥5 to 10) + Visit + Treatment\*Visit|least squares mean difference|-0.68|STANDARD_ERROR_OF_MEAN|0.485||0.1671|TWO_SIDED|95.0|-1.65|0.29|||ANCOVA|||||0.29|-1.65|0.1671
70982499|NCT05635838|141473349|SUPERIORITY|Response Variable = Treatment + Baseline AN Count Category (≥3 to 4, ≥5 to 10) + Visit + Treatment\*Visit|least squares mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.728||0.7982|TWO_SIDED|95.0|-1.27|1.64|||ANCOVA|||||1.64|-1.27|0.7982
70982500|NCT05635838|141473350|SUPERIORITY|Response Variable = Treatment + Baseline AN Count Category (≥3 to 4, ≥5 to 10) + Visit + Treatment\*Visit|least squares mean difference|0.94|STANDARD_ERROR_OF_MEAN|0.73||0.2031|TWO_SIDED|95.0|-0.52|2.4|||ANCOVA|||||2.40|-0.52|0.2031
70982501|NCT05635838|141473352|SUPERIORITY|Response Variable = Treatment + Baseline AN Count Category (≥3 to 4, ≥5 to 10) + Visit + Treatment\*Visit|least squares mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.683||0.2387|TWO_SIDED|95.0|-2.2|0.56|||ANCOVA|||||0.56|-2.20|0.2387
70982502|NCT03518840|141473382|SUPERIORITY||Mean Difference (Final Values)|-1.9615|STANDARD_ERROR_OF_MEAN|0.3329|<|0.001|TWO_SIDED|95.0|-2.6299|-1.2932|||paired t-test, 2 sided|||The null hypothesis is that there is no change in the baseline ASLR score following four weeks of SIJ belt therapy.||-1.2932|-2.6299|<.001
70982503|NCT03518840|141473383|SUPERIORITY||Median Difference (Final Values)|-1.9474|STANDARD_ERROR_OF_MEAN|0.3353|<|0.001|TWO_SIDED|95.0|-2.619|-1.2757|||paired t-test, 2 sided|||The null hypothesis is that there is no change in the baseline NRS score following four weeks of SIJ belt therapy.||-1.2757|-2.6190|<.001
70982504|NCT05652660|141473384|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|120.5|||||TWO_SIDED|90.0|104.77|138.59|||||The ratios (and 90% CIs) are expressed as percentages.|Rosuvastatin administered alone as the Reference and ARV-471 coadministered with rosuvastatin as the Test. Natural log transformed Cmax was analyzed using a mixed effect model with treatment as fixed effects and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||138.59|104.77|
70982505|NCT05652660|141473385|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|110.56|||||TWO_SIDED|90.0|103.53|118.06|||||The ratios (and 90% CIs) are expressed as percentages.|Rosuvastatin administered alone as the Reference and ARV-471 coadministered with rosuvastatin as the Test. Natural log transformed AUClast was analyzed using a mixed effect model with treatment as fixed effects and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||118.06|103.53|
70982506|NCT01416181|141473411|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.2866|TWO_SIDED|95.0|0.66|1.13|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on ≥ 1 of EDSS, T25FW, or 9HPT at 2 years||1.13|0.66|0.2866
70982507|NCT01416181|141473411|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.753|TWO_SIDED|95.0|0.74|1.53|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on EDSS||1.53|0.74|0.7530
70982508|NCT01416181|141473411|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9137|TWO_SIDED|95.0|0.74|1.3|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on T25FW||1.30|0.74|0.9137
70982509|NCT01416181|141473411|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.0012|TWO_SIDED|95.0|0.4|0.8|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).||Confirmed progressors on 9HPT (either hand)||0.80|0.40|0.0012
70982510|NCT01416181|141473411|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.1251|TWO_SIDED|95.0|0.48|1.09|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).||Confirmed progressors on 9HPT (dominant hand)||1.09|0.48|0.1251
70982511|NCT01416181|141473411|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58||||0.0091|TWO_SIDED|95.0|0.39|0.87|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).||Confirmed progressors on 9HPT (non-dominant hand)||0.87|0.39|0.0091
70982512|NCT01416181|141473413|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.4369|TWO_SIDED|95.0|0.8|1.7|||Regression, Logistic|Based on logistic regression, adjusted for baseline EDSS (\<=5.5 or \>=6) and T25FW.|active/placebo|||1.70|0.80|0.4369
70982513|NCT01416181|141473414|SUPERIORITY_OR_OTHER|||||||0.5409|||||||ANCOVA|p-value for comparison between the active and placebo groups at Week 96 is based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or \>=6) and BL MSWS-12.||||||0.5409
70982514|NCT01416181|141473415|SUPERIORITY_OR_OTHER|||||||0.2586|||||||ANCOVA|p-value for comparison between active and placebo groups at Week 96 is based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or \>=6) and BL ABILHAND.||||||0.2586
70982515|NCT01416181|141473416|SUPERIORITY_OR_OTHER|||||||0.1529|||||||ANCOVA|p-value for comparison between active \& placebo groups at Wk 96 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL MSIS-29 physical score.||||||0.1529
70982516|NCT01416181|141473417|SUPERIORITY_OR_OTHER|||||||0.2424||||||natalizumab participants had a baseline after 6 months of treatment and the placebo-to-natalizumab group had a baseline of initiation of treatment|ANCOVA|p-value for comparison between active and placebo groups at Week 96 is based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or \>=6) and BL brain volume.||Only participants with BL brain volume are included in the p-value calculation.||||0.2424
70982517|NCT01416181|141473418|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.1052|TWO_SIDED|95.0|0.58|1.05|||Regression, Logistic|Based on logistic regression, adjusted for baseline EDSS (\<=5.5 or \>=6).||||1.05|0.58|0.1052
70982518|NCT01416181|141473419|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.0205|TWO_SIDED|95.0|0.47|0.94|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on ≥ 1 of EDSS, T25FW, or 9HPT at 156 weeks||0.94|0.47|0.0205
70982519|NCT01416181|141473419|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.1305|TWO_SIDED|95.0|0.48|1.1|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on EDSS at 156 weeks||1.10|0.48|0.1305
70982520|NCT01416181|141473419|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.1988|TWO_SIDED|95.0|0.57|1.12|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on T25FW at 156 weeks||1.12|0.57|0.1988
70982521|NCT01416181|141473419|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.0093|TWO_SIDED|95.0|0.39|0.88|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on 9HPT (either hand) at 156 weeks||0.88|0.39|0.0093
70982522|NCT01416181|141473419|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63||||0.054|TWO_SIDED|95.0|0.39|1.01|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors onm 9HPT (dominant hand) at 156 weeks||1.01|0.39|0.0540
70982523|NCT01416181|141473419|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.141|TWO_SIDED|95.0|0.44|1.12|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on 9HPT (non-dominant hand) at 156 weeks||1.12|0.44|0.1410
70982524|NCT01416181|141473420|SUPERIORITY_OR_OTHER|||||||0.0273|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL T25FW.||Week 156||||0.0273
70982525|NCT01416181|141473420|SUPERIORITY_OR_OTHER|||||||0.1974|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL T25FW.||CP Group: Week 156||||0.1974
70982526|NCT01416181|141473420|SUPERIORITY_OR_OTHER|||||||0.2506|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL T25FW.||NP Group: Week 156||||0.2506
70982527|NCT01416181|141473421|SUPERIORITY_OR_OTHER|||||||0.096|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL T25FW.||Overall: Week 156||||0.0960
70982528|NCT01416181|141473421|SUPERIORITY_OR_OTHER|||||||0.4957|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL T25FW.||CP Group: Week 156||||0.4957
70982529|NCT01416181|141473421|SUPERIORITY_OR_OTHER|||||||0.2916|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL T25FW.||NP Group: Week 156||||0.2916
70982530|NCT01416181|141473422|SUPERIORITY_OR_OTHER|||||||0.1119|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (dominant hand).||Overall, Week 156||||0.1119
70982531|NCT01416181|141473422|SUPERIORITY_OR_OTHER|||||||0.1129|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (dominant hand).||CP Group: Week 156||||0.1129
70982532|NCT01416181|141473422|SUPERIORITY_OR_OTHER|||||||0.2351|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (dominant hand).||NP Group: Week 156||||0.2351
71036575|NCT03214588|141581569|SUPERIORITY||Least Squares Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.293||0.967|TWO_SIDED|90.0|0.06|1.04||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||1.04|0.06|0.967
70982533|NCT01416181|141473423|SUPERIORITY_OR_OTHER|||||||0.0261|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (dominant hand).||Overall: Week 156||||0.0261
70982534|NCT01416181|141473423|SUPERIORITY_OR_OTHER|||||||0.0585|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (dominant hand).||CP Group: Week 156||||0.0585
70982535|NCT01416181|141473423|SUPERIORITY_OR_OTHER|||||||0.6095|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (dominant hand).||NP Group: Week 156||||0.6095
70982536|NCT01416181|141473424|SUPERIORITY_OR_OTHER|||||||0.723|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (non-dominant hand).||Overall: Week 156||||0.7230
70982537|NCT01416181|141473424|SUPERIORITY_OR_OTHER|||||||0.8781|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (non-dominant hand).||CP Group: Week 156||||0.8781
70982538|NCT01416181|141473424|SUPERIORITY_OR_OTHER|||||||0.2751|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (non-dominant hand).||NP Group: Week 156||||0.2751
70982539|NCT01416181|141473425|SUPERIORITY_OR_OTHER|||||||0.5051|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (non-dominant hand).||Overall: Week 156||||0.5051
70982540|NCT01416181|141473425|SUPERIORITY_OR_OTHER|||||||0.7283|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (non-dominant hand).||CP Group: Week 156||||0.7283
70982541|NCT01416181|141473425|SUPERIORITY_OR_OTHER|||||||0.1666|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (non-dominant hand).||NP Group: Week 156||||0.1666
70982542|NCT01416181|141473426|SUPERIORITY_OR_OTHER|||||||0.433|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||Overall: Week 156||||0.4330
70982543|NCT01416181|141473426|SUPERIORITY_OR_OTHER|||||||0.7122|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||CP Group: Week 156||||0.7122
70982544|NCT01416181|141473426|SUPERIORITY_OR_OTHER|||||||0.3861|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||NP Group: Week 156||||0.3861
70982545|NCT01416181|141473427|SUPERIORITY_OR_OTHER|||||||0.7225|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||Overall: Week 156||||0.7225
70982546|NCT01416181|141473427|SUPERIORITY_OR_OTHER|||||||0.9121|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||CP Group: Week 156||||0.9121
70982547|NCT01416181|141473427|SUPERIORITY_OR_OTHER|||||||0.2594|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||NP Group: Week 156||||0.2594
70982548|NCT01416181|141473428|SUPERIORITY_OR_OTHER|||||||0.8066|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 6MWT.||Week 156||||0.8066
70982549|NCT01416181|141473430|SUPERIORITY_OR_OTHER|||||||0.7084|||||||ANCOVA|p-value for comparison between active \& placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL MSIS-29 physical score.||||||0.7084
70982550|NCT01416181|141473432|SUPERIORITY_OR_OTHER|||||||0.3465|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL SDMT.||Week 156||||0.3465
71036576|NCT03214588|141581569|SUPERIORITY||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.338||0.529|TWO_SIDED|90.0|-0.54|0.59||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||0.59|-0.54|0.529
71036577|NCT03214588|141581569|SUPERIORITY||Least Squares Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.279||0.88|TWO_SIDED|90.0|-0.13|0.8||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||0.80|-0.13|0.880
71036578|NCT03214588|141581569|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.408||0.599|TWO_SIDED|90.0|-0.58|0.79||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||0.79|-0.58|0.599
71036579|NCT03214588|141581569|SUPERIORITY||Least Squares Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.333||0.846|TWO_SIDED|90.0|-0.21|0.9||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||0.90|-0.21|0.846
71036580|NCT03214588|141581570|SUPERIORITY||Odds Ratio (OR)|0.0|||>|0.999||||||P-value was from Fisher's exact test. Odds ratio was obtained from Cochran-Mantel-Haenszel with ambulation status at randomization as a stratification factor.|Fisher Exact|||At Least 15% Reduction from Baseline||||>0.999
71036581|NCT03214588|141581570|SUPERIORITY||Odds Ratio (OR)|0.0|||>|0.999||||||P-value was from Fisher's exact test. Odds ratio was obtained from Cochran-Mantel-Haenszel with ambulation status at randomization as a stratification factor.|Fisher Exact|||At Least 15% Reduction from Baseline||||>0.999
70982551|NCT01416181|141473436|SUPERIORITY_OR_OTHER|||||||0.007||||||natalizumab participants had a baseline after 6 months of treatment and the placebo-to-natalizumab group had a baseline of initiation of treatment|ANCOVA|p-value for comparison between active \& placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL normalized brain volume.||Percentage change from Week 24 to Week 156||||0.0070
70982552|NCT01416181|141473437|SUPERIORITY_OR_OTHER|||||||0.5034||||||natalizumab participants had a baseline after 6 months of treatment and the placebo-to-natalizumab group had a baseline of initiation of treatment|ANCOVA|p-value for comparison between active \& placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL WGM brain volume||Percentage hange from Baseline to Week 156||||0.5034
70982553|NCT01416181|141473438|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value for comparison between the active and placebo groups at Week 156 compared to Week 108 is based on negative binomial regression model, adjusted for baseline EDSS (\<=5.5 or \>=6) and baseline volume of T2 lesions.|negative binomial regression model|natalizumab participants had a baseline after 6 months of treatment and the placebo-to-natalizumab group had a baseline of initiation of treatment||Week 156||||< 0.0001
70982554|NCT01121406|141473494|SUPERIORITY_OR_OTHER||Difference in Kaplan-Meier DC rates|-12.5|||||TWO_SIDED|95.0|-31.1|6.0|||||"95% CI using Greenwood´s variance estimate.~Volasertib (BI 6727) minus Cytotoxic."|Kaplan Meier estimates and confidence intervals (CI) were calculated using Greenwood's variance estimate within each treatment arm and the asymptotic CI for the difference in the rates found. The time was censored in those cases where there was no death or progression until the last trial visit||6.0|-31.1|
70982555|NCT01121406|141473495|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.66|1.53|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727) /Cytotoxic"|||1.53|0.66|
70982556|NCT01121406|141473496|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.63|1.42|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727) /Cytotoxic"|||1.42|0.63|
70982557|NCT01121406|141473499|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.73|1.7|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"|||1.70|0.73|
70982558|NCT01121406|141473500|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.4|1.61|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"|||1.61|0.40|
70982559|NCT01121406|141473501|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.37|1.65|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"|||1.65|0.37|
70982560|NCT01121406|141473502|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.39|1.93|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"|||1.93|0.39|
70982561|NCT01121406|141473503|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.33|1.47|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"|||1.47|0.33|
70982562|NCT01121406|141473504|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.27|||||TWO_SIDED|95.0|0.09|0.77|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"|||0.77|0.09|
70982563|NCT03215277|141473534|SUPERIORITY||Mean Posterior Difference|0.23|||||TWO_SIDED|95.0|-0.14|0.6|||Regression, Linear|||Results were based on a complete case (ie, data as observed) Bayesian linear model with the change from Baseline in ASDAS as the independent variable. Treatment was included as a predictor in the model and Baseline ASDAS as a covariate. The mean posterior difference and 95% credible interval were presented for the BKZ vs CZP comparison.||0.60|-0.14|
70982564|NCT03215277|141473534|SUPERIORITY||PR[Diff > 0%](%)|88.4|||||TWO_SIDED||||||Regression, Linear|||Results were based on a complete case (ie, data as observed) Bayesian linear model with the change from Baseline in ASDAS as the independent variable. Treatment was included as a predictor in the model and Baseline ASDAS as a covariate. Pr\[Diff\>0%\](%) refers to the probability that the mean change from Baseline in ASDAS in the BKZ group was greater than the mean change from Baseline in ASDAS in the CZP group.||||
70982565|NCT01882725|141473546|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
70982566|NCT01882725|141473547|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
70982567|NCT02498652|141473562|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|103.0|||||TWO_SIDED|90.0|90.7|117.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects.||||117|90.7|
70982568|NCT02498652|141473562|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|92.6|||||TWO_SIDED|90.0|78.1|110.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects.||||110|78.1|
70982569|NCT02498652|141473562|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|102.0|||||TWO_SIDED|90.0|85.7|120.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||120|85.7|
70982570|NCT02498652|141473562|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|88.9|||||TWO_SIDED|90.0|78.4|101.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||101|78.4|
70982571|NCT02498652|141473562|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|100.0|||||TWO_SIDED|90.0|87.7|114.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale||||114|87.7|
71036582|NCT03214588|141581570|SUPERIORITY||Odds Ratio (OR)|0.0|||>|0.999||||||P-value was from Fisher's exact test. Odds ratio was obtained from Cochran-Mantel-Haenszel with ambulation status at randomization as a stratification factor.|Fisher Exact|||At Least 20% Reduction from Baseline||||>0.999
71036583|NCT03214588|141581570|SUPERIORITY||Odds Ratio (OR)|0.0|||>|0.999||||||P-value was from Fisher's exact test. Odds ratio was obtained from Cochran-Mantel-Haenszel with ambulation status at randomization as a stratification factor.|Fisher Exact|||At Least 20% Reduction from Baseline||||>0.999
71036584|NCT03480763|141581588|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|4.2||||0.043|TWO_SIDED|95.0|0.1|8.5|||Miettinen & Nurminen|||Injection site redness/erythema||8.5|0.1|0.043
71036585|NCT03480763|141581588|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|13.7|||<|0.001|TWO_SIDED|95.0|6.0|21.2|||Miettinen & Nurminen|||Injection site tenderness/pain||21.2|6.0|<0.001
71036586|NCT03480763|141581588|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|4.8||||0.077|TWO_SIDED|95.0|-0.5|10.2|||Miettinen & Nurminen|||Injection site swelling||10.2|-0.5|0.077
71036587|NCT03480763|141581589|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.6||||0.855|TWO_SIDED|95.0|-5.5|6.6|||Miettinen & Nurminen|||Injection site redness/erythema||6.6|-5.5|0.855
71036588|NCT03480763|141581589|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|3.5||||0.385||95.0|-4.4|11.3|||Miettinen & Nurminen|||Injection site tenderness/pain||11.3|-4.4|0.385
71036589|NCT03480763|141581589|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|2.0||||0.577|TWO_SIDED|95.0|-5.1|9.2|||Miettinen & Nurminen|||Injection site swelling||9.2|-5.1|0.577
71036590|NCT03480763|141581590|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|1.2||||0.523|TWO_SIDED|95.0|-2.5|4.9|||Miettinen & Nurminen|||Joint pain/arthralgia||4.9|-2.5|0.523
71036591|NCT03480763|141581590|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|9.7||||0.002|TWO_SIDED|95.0|3.7|15.6|||Miettinen & Nurminen|||Tiredness/fatigue||15.6|3.7|0.002
71036592|NCT03480763|141581590|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|1.4||||0.597|TWO_SIDED|95.0|-3.9|6.7|||Miettinen & Nurminen|||Headache||6.7|-3.9|0.597
71097273|NCT05103332|141703588|SUPERIORITY||Difference in LS Mean|-7.9|STANDARD_ERROR_OF_MEAN|1.36|<|0.0001|TWO_SIDED|95.0|-10.6|-5.3||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to amlodipine) and placebo (add on to amlodipine), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05. All collected data for SBP assessed by ABPM, were included in the analysis for this endpoint.||-5.3|-10.6|<0.0001
71097274|NCT05103332|141703589|SUPERIORITY||Difference in LS Mean|-8.6|STANDARD_ERROR_OF_MEAN|1.16|<|0.0001|TWO_SIDED|95.0|-10.9|-6.3||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to amlodipine) and placebo (add on to amlodipine), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05. All collected data for office SBP were included in the analysis for this endpoint.||-6.3|-10.9|<0.0001
71097275|NCT05103332|141703590|SUPERIORITY||Odds Ratio (OR)|5.08|||<|0.0001|TWO_SIDED|95.0|2.43|10.61||Logistic regression model included treatment and race (black or all other races) as factors and baseline 24-hour mean SBP and baseline eGFR as covariates.|Regression, Logistic|||A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05.||10.61|2.43|<0.0001
71036593|NCT03480763|141581590|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|6.6||||0.016|TWO_SIDED|95.0|1.2|12.1|||Miettinen & Nurminen|||Muscle pain/myalgia||12.1|1.2|0.016
71036594|NCT03480763|141581591|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.1||||0.961|TWO_SIDED|95.0|-4.4|4.7|||Miettinen & Nurminen|||Joint pain/arthralgia||4.7|-4.4|0.961
71036595|NCT03480763|141581591|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|4.0||||0.252|TWO_SIDED|95.0|-2.8|10.8|||Miettinen & Nurminen|||Tiredness/fatigue||10.8|-2.8|0.252
70982572|NCT02498652|141473562|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|101.0|||||TWO_SIDED|90.0|85.5|119.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||119|85.5|
70982573|NCT02498652|141473565|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|100.0|||||TWO_SIDED|90.0|94.3|107.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||107|94.3|
70982574|NCT02498652|141473565|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|98.0|||||TWO_SIDED|90.0|90.4|106.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||106|90.4|
70982575|NCT02498652|141473565|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|104.0|||||TWO_SIDED|90.0|94.5|114.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||114|94.5|
70982576|NCT02498652|141473565|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|92.0|||||TWO_SIDED|90.0|86.7|97.7|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||97.7|86.7|
70982577|NCT02498652|141473565|NON_INFERIORITY|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|98.9|||||TWO_SIDED|90.0|91.0|107.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||107|91.0|
70982578|NCT02498652|141473565|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%|Geometric Least Squares Mean Ratio (%)|97.5|||||TWO_SIDED|90.0|92.8|102.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||102|92.8|
70982579|NCT04207710|141473571|SUPERIORITY|||||||0.317||||||A priori threshold for significance was p\<0.05.|Friedman|||Comparison of incidence of positive growth in samples obtained following application of ChloraPrep vs. ChloraPrep followed by Gebauer's Ethyl Chloride.||||0.317
70982580|NCT04207710|141473571|SUPERIORITY|||||||0.317||||||A priori threshold was p\<0.05|Friedman|||Comparison of incidence of positive growth in samples obtained following application of ChloraPrep vs. ChloraPrep followed by Gebauer's Ethyl Chloride.||||0.317
71097276|NCT05103332|141703601|SUPERIORITY||Difference in LS Mean|-6.7|STANDARD_ERROR_OF_MEAN|1.76|=|0.0002|TWO_SIDED|95.0|-10.2|-3.3||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to olmesartan) and placebo (add on to olmesartan), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \< 0.05. Data for office SBP assessed while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.||-3.3|-10.2|=0.0002
70982581|NCT04207710|141473571|SUPERIORITY|||||||0.317||||||A priori threshold was p\<0.05|Friedman|||Comparison of incidence of positive growth in samples obtained following application of ChloraPrep vs. ChloraPrep followed by Gebauer's Pain Ease.||||0.317
70982582|NCT04207710|141473571|SUPERIORITY|||||||0.317||||||A priori threshold was p\<0.05|Friedman|||Comparison of incidence of positive growth in samples obtained following application of ChloraPrep vs. ChloraPrep followed by Gebauer's Pain Ease.||||0.317
70982583|NCT00095303|141473578|SUPERIORITY_OR_OTHER||slope of linear trajectory of drug use|0.05||||0.27|TWO_SIDED|95.0|-0.04|0.14|||Mixed Models Analysis||The parameter estimated is the regression coefficient on the interaction of the BSFT treatment assignment and the linear time trend.|Null Hypothesis: BSFT will be significantly more effective than TAU in reducing adolescent drug abuse, defined as the percentage of drug use days in 28-day periods. The outcome variable is the percentage of days of drug use within a 28-day period. This variable constructed from the Timeline-Follow-back instrument and measured as the sum of the number of days with positive use in 28-day increments. Hypothesis tested using hierarchical linear models.||.14|-.04|.27
70982584|NCT00095303|141473580|SUPERIORITY_OR_OTHER||Slope|-0.1||||0.26|TWO_SIDED|95.0|-0.28|0.08|||Mixed Models Analysis||The parameter estimated is the regression coefficient on the interaction of BSFT treatment assignment and the linear time trend.|Null hypothesis: It is hypothesized that BSFT will be significantly more effective than TAU in decreasing adolescent externalizing problem behaviors||0.08|-0.28|.26
70982585|NCT00095303|141473596|SUPERIORITY_OR_OTHER||Rate Ratio|0.94||||0.21|TWO_SIDED|95.0|0.82|1.09|||GEE|||Null Hypothesis: BSFT will be significantly more effective than TAU in the rates of drug use, defined as the percentage of drug use days in last 90 days. The primary hypothesis will be evaluated in terms of % of days of drug use in the last 90 days, assessed by the timeline follow-back. The general analytic approach will use generalized estimating equation (GEE) with negative binomial distribution comparing the BSFT and TAU participants||1.09|.82|.21
70982586|NCT00095303|141473598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||<|0.006|TWO_SIDED|95.0|-0.71|-0.12|||GEE|||Null hypothesis: It is hypothesized that BSFT will be significantly more effective than TAU in the level of externalizing problem behaviors||-.12|-.71|<.006
70982587|NCT00095303|141473599|SUPERIORITY_OR_OTHER||Slope|0.12||||0.015|TWO_SIDED|95.0|0.03|0.22|||Mixed Models Analysis|||Null hypothesis: BSFT will be significantly more effective than TAU in improving family functioning.The four components of the 'Parenting Practices Inventory' will be used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are 'Positive Parenting', 'Discipline Effectiveness,' 'Avoidance of Discipline' and 'Monitoring' scales from the Pittsburgh Youth Survey. Hypothesis will be analyzed as using hierarchical linear models.||.22|.03|.015
70982588|NCT00095303|141473603|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.68||||0.12|TWO_SIDED|95.0|-0.18|1.54|||GEE|||||1.54|-.18|.12
70982589|NCT00095303|141473604|SUPERIORITY_OR_OTHER||Slope|0.33||||0.12|TWO_SIDED|95.0|-0.09|0.76|||GEE||The parameter estimated is the regression coefficient on the interaction of BSFT treatment assignment and the linear time trend.|Null hypothesis: BSFT will be significantly more effective than TAU in decreasing sexually risky behaviors. The total score of the 'HIV/Sex Risk Behaviors' measure will be used as the outcome.Hypothesis analyzed using the hierarchical linear model.||.76|-.09|.12
70982590|NCT00095303|141473608|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.14||||0.23|TWO_SIDED|95.0|-0.09|0.37|||GEE|||||.37|-.09|.23
70982591|NCT01499576|141473609|SUPERIORITY_OR_OTHER||percent agreement|89.2|||||TWO_SIDED|||||||||||||
70982592|NCT01499576|141473610|SUPERIORITY_OR_OTHER||Kappa index of agreement|0.808|||<|0.01|TWO_SIDED||||||Kappa index of agreement|||||||<0.01
70982593|NCT01499576|141473611|SUPERIORITY_OR_OTHER||persent of adverse event|10.48|||||TWO_SIDED|||||||||||||
70982594|NCT00397150|141473631|SUPERIORITY_OR_OTHER||Prevalence ratio|2.29|||||TWO_SIDED|95.0|1.33|3.92||||||||3.92|1.33|
70982595|NCT00397150|141473636|SUPERIORITY_OR_OTHER||Prevalence ratio|1.89|||||TWO_SIDED|95.0|1.7|2.11||||||||2.11|1.70|
71097277|NCT05103332|141703602|SUPERIORITY||Difference in LS Mean|-1.8|STANDARD_ERROR_OF_MEAN|1.42|=|0.2103|TWO_SIDED|95.0|-4.6|1.0||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to olmesartan) and placebo (add on to olmesartan), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05. All collected data for SBP assessed by ABPM, were included in the analysis for this endpoint.||1.0|-4.6|=0.2103
70982596|NCT00397150|141473637|SUPERIORITY_OR_OTHER||Prevalence ratio|1.72|||||TWO_SIDED|95.0|1.12|2.63||||||||2.63|1.12|
70982597|NCT00195351|141473642|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0||||0.009||95.0|-13.1|5.1|||t-test, 2 sided|||||5.1|-13.1|0.009
70982598|NCT00195351|141473643|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.4||||0.02||95.0|-14.5|7.8|||t-test, 2 sided|||||7.8|-14.5|0.020
70982599|NCT00195351|141473644|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.9||||0.015||95.0|-13.9|8.1|||Method of Mehrotra and Railkar|||||8.1|-13.9|0.015
70982600|NCT03322657|141473652|SUPERIORITY||Hazard Ratio (HR)|3.8|||<|0.001|TWO_SIDED|95.0|2.2|6.5|||Cox proportional hazard model|||||6.5|2.2|<0.001
70982601|NCT03322657|141473653|SUPERIORITY||Median Difference (Final Values)|6.3||||0.13|TWO_SIDED|95.0|-2.0|14.0|||Wilcoxon (Mann-Whitney)|||||14|-2.0|0.13
70982602|NCT03322657|141473654|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.3|TWO_SIDED|95.0|0.43|1.34|||Cox proportional hazard model|||||1.34|0.43|0.30
70982603|NCT03322657|141473655|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.21|TWO_SIDED|95.0|-0.35|1.0|||t-test, 2 sided|||||1.00|-0.35|0.21
70982604|NCT03322657|141473656|SUPERIORITY||Mean Difference (Final Values)|0.82||||0.04|TWO_SIDED|95.0|-0.18|1.81|||t-test, 2 sided|||||1.81|-0.18|0.04
70982605|NCT00843180|141473674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_DEVIATION|0.0||0.8|TWO_SIDED|95.0|-5.4|4.2||unadjusted|t-test, 2 sided||this was a feasibility pilot study CI is descriptor of dispersion|comparison between groups by t-test||4.2|-5.4|0.80
70982606|NCT00843180|141473675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.38|STANDARD_DEVIATION|0.0||0.29|TWO_SIDED|95.0|-6.9|2.1||unadjusted|t-test, 2 sided||CI serves as dispersion measure|||2.1|-6.9|0.29
70982607|NCT00843180|141473676|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.8|STANDARD_DEVIATION|0.0||0.78|TWO_SIDED|95.0|-31.9|24.3|||t-test, 2 sided||95% CI is dispersion parameter|||24.3|-31.9|0.78
70982608|NCT00843180|141473677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|STANDARD_DEVIATION|0.0||0.7|TWO_SIDED|95.0|-9.5|13.2|||t-test, 2 sided|unadjusted|95%CI is dispersion measure|||13.2|-9.5|0.70
70982609|NCT01662999|141473718|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.943|||||TWO_SIDED|90.0|0.867|1.026|||Mixed Models Analysis|||The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.026|0.867|
70982610|NCT01662999|141473719|SUPERIORITY_OR_OTHER||Ration of adjusted geometric mean|0.984|||||TWO_SIDED|90.0|0.961|1.008|||Mixed Models Analysis|||Treatment B versus C in AUC(INF). The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.008|0.961|
70982611|NCT01662999|141473721|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.99|||||TWO_SIDED|90.0|0.966|1.014|||Mixed Models Analysis|||Treatment B versus C in AUC(0-T). The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.014|0.966|
70982612|NCT01662999|141473723|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.927|||||TWO_SIDED|90.0|0.883|0.972|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of saxagliptin. The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||0.972|0.883|
71036596|NCT03480763|141581591|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-0.5||||0.852|TWO_SIDED|95.0|-5.8|4.8|||Miettinen & Nurminen|||Headache||4.8|-5.8|0.852
71036597|NCT03480763|141581591|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|4.9||||0.125|TWO_SIDED|95.0|-1.4|11.2|||Miettinen & Nurminen|||Muscle pain/myalgia||11.2|-1.4|0.125
71036598|NCT03480763|141581592|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.2|1.2||||||Vaccine-related SAEs following V114 or Prevnar 13™||1.2|-1.2|
71036599|NCT03480763|141581593|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.3|1.3||||||Vaccine-related SAEs following PNEUMOVAX™23||1.3|-1.3|
71036600|NCT03480763|141581594|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.38|||||TWO_SIDED|95.0|1.1|1.74||||||Serotype 1 (Shared)||1.74|1.10|
70982613|NCT01662999|141473725|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.055|||||TWO_SIDED|90.0|1.004|1.109|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of 5-OH saxagliptin (metabolite of saxagliptin). The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.109|1.004|
70982614|NCT01662999|141473726|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.991|||||TWO_SIDED|90.0|0.96|1.022|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of saxagliptin. The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.022|0.960|
70982615|NCT01662999|141473727|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.991|||||TWO_SIDED|90.0|0.961|1.022|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of saxagliptin. The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.022|0.961|
70982616|NCT01662999|141473728|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.085|||||TWO_SIDED|90.0|1.058|1.113|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of 5-OH saxagliptin (metabolite). The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.113|1.058|
70982617|NCT01662999|141473729|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|1.085|||||TWO_SIDED|90.0|1.058|1.113|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of 5-OH saxagliptin (metabolite). The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.113|1.058|
70982618|NCT01662999|141473730|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.994|||||TWO_SIDED|90.0|0.96|1.03|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of saxagliptin total active moiety. The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.030|0.960|
71036601|NCT03480763|141581594|OTHER|GMT ratio and 95% CI are estimated from a cLDA model|GMT Ratio|1.08|||||TWO_SIDED|95.0|0.9|1.29||||||Serotype 3 (Shared)||1.29|0.90|
71036602|NCT03480763|141581594|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.06|||||TWO_SIDED|95.0|0.85|1.32||||||Serotype 4 (Shared)||1.32|0.85|
71036603|NCT03480763|141581594|OTHER|GMT ratio and 95% CI are estimated from a cLDA model|GMT Ratio|1.21|||||TWO_SIDED|95.0|0.94|1.56||||||Serotype 5 (Shared)||1.56|0.94|
71036604|NCT03480763|141581594|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.16|||||TWO_SIDED|95.0|0.95|1.43||||||Serotype 6A (Shared)||1.43|0.95|
71036605|NCT03480763|141581594|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.12|||||TWO_SIDED|95.0|0.93|1.35||||||Serotype 6B (Shared)||1.35|0.93|
71036606|NCT03480763|141581594|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.06|||||TWO_SIDED|95.0|0.9|1.25||||||Serotype 7F (Shared)||1.25|0.90|
71036607|NCT03480763|141581594|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.91|1.33||||||Serotype 9V (Shared)||1.33|0.91|
71036608|NCT03480763|141581594|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.27|||||TWO_SIDED|95.0|1.05|1.53||||||Serotype 14 (Shared)||1.53|1.05|
71036609|NCT03480763|141581594|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.13|||||TWO_SIDED|95.0|0.95|1.34||||||Serotype 18C (Shared)||1.34|0.95|
71036610|NCT03480763|141581594|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.15|||||TWO_SIDED|95.0|0.96|1.38||||||Serotype 19A (Shared)||1.38|0.96|
71036611|NCT03480763|141581594|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.03|||||TWO_SIDED|95.0|0.89|1.2||||||Serotype 19F (Shared)||1.20|0.89|
71036612|NCT03480763|141581594|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.28|||||TWO_SIDED|95.0|1.01|1.61||||||Serotype 23F (Shared)||1.61|1.01|
71036613|NCT03480763|141581594|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.63|||||TWO_SIDED|95.0|1.29|2.06||||||Serotype 22F (Unique to V114)||2.06|1.29|
70982619|NCT01662999|141473731|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.046|||||TWO_SIDED|90.0|1.029|1.064|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the AUC(0-T) of saxagliptin total active moiety. The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.064|1.029|
70982620|NCT02234622|141473770|SUPERIORITY||Mean Difference (Final Values)|-5.0|STANDARD_ERROR_OF_MEAN|1.6||0.002|TWO_SIDED|95.0|-8.2|-1.8|||Mixed Models Analysis|||||-1.8|-8.2|0.002
70982621|NCT02234622|141473771|SUPERIORITY||Mean Difference (Net)|-6.1|STANDARD_ERROR_OF_MEAN|2.2||0.005|TWO_SIDED|95.0|-10.3|-1.8|||Mixed Models Analysis|||||-1.8|-10.3|0.005
70982622|NCT02234622|141473772|SUPERIORITY||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|2.6||0.042|TWO_SIDED|95.0|-11.9|-1.6|||Mixed Models Analysis|||||-1.6|-11.9|0.042
70982623|NCT02234622|141473773|SUPERIORITY||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|1.4||0.482|TWO_SIDED|95.0|-4.2|1.1|||Mixed Models Analysis|||||1.1|-4.2|0.482
70982624|NCT02234622|141473774|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.7||0.635|TWO_SIDED|95.0|-4.7|1.9|||Mixed Models Analysis|||||1.9|-4.7|0.635
70982625|NCT02234622|141473775|SUPERIORITY||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|1.8||0.367|TWO_SIDED|95.0|-6.0|1.1|||Mixed Models Analysis|||||1.1|-6.0|0.367
70982626|NCT02234622|141473776|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.4||0.668|TWO_SIDED|95.0|-0.5|1.0|||Mixed Models Analysis|||||1.0|-0.5|0.668
70982627|NCT05175170|141473821|OTHER||Mean Difference (Final Values)|-33.902|||<|0.001|TWO_SIDED||||||t-test, 1 sided|||The hypothesis of this analysis was that using the AFFRMED would increase fertility-related knowledge. This paired-samples t-test compares participants' pre- and post-test knowledge scores.||||<.001
70982628|NCT05175170|141473821|OTHER||Mean Difference (Final Values)|-26.098|||<|0.001|TWO_SIDED||||||t-test, 1 sided|||The hypothesis of this analysis was that using the AFFRMED would increase fertility-related knowledge. This paired-samples t-test compares participants' pre- and post-test knowledge scores.||||<.001
70982629|NCT05175170|141473822|OTHER||Mean Difference (Final Values)|-20.202||||0.002|TWO_SIDED||||||t-test, 1 sided|||The hypothesis of this analysis was that using the AFFRMED would increase fertility-related decision self-efficacy. This paired-samples t-test compares participants' pre- and post-test decision self-efficacy scores.||||0.002
70982630|NCT05175170|141473822|OTHER||Mean Difference (Final Values)|-8.081||||0.051|TWO_SIDED||||||t-test, 1 sided|||The hypothesis of this analysis was that using the AFFRMED would increase fertility-related decision self-efficacy. This paired-samples t-test compares participants' pre- and post-test decision self-efficacy scores.||||0.051
70982631|NCT04090164|141473826|OTHER||Odds Ratio (OR)|2.406||||0.0027|TWO_SIDED|95.0|1.341|4.316|||Fisher Exact|||Fisher exact test was used for testing of association of Breast Cancer diagnosis with anti-HCV test status.||4.316|1.341|0.0027
70982632|NCT04090164|141473826|OTHER||Odds Ratio (OR)|7.032||||0.0034|TWO_SIDED|95.0|1.582|31.25|||Fisher Exact|||Fisher exact test was used to test the association of Breast Cancer diagnosis with anti-HCV test result in women younger than 45 years.||31.25|1.582|0.0034
70982633|NCT01650805|141473828|SUPERIORITY_OR_OTHER|||||||0.074|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified Analysis by Sokal score||||||0.074
70982634|NCT01650805|141473830|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified Analysis by Sokal score||||||<0.001
70982635|NCT01650805|141473831|SUPERIORITY_OR_OTHER|||||||0.317|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified Analysis by Sokal score||||||0.317
70982636|NCT02625402|141473834|EQUIVALENCE|Knowledge scores within 10% points|Mean Difference (Final Values)|6.4|STANDARD_ERROR_OF_MEAN|7.6|<|0.05|TWO_SIDED|95.0|-8.8|21.5|||t-test, 2 sided|||||21.5|-8.8|<0.05
70982637|NCT01877655|141473837|SUPERIORITY||Odds Ratio (OR)|1.27||||0.205|TWO_SIDED|95.0|0.87|1.85||P-value based on CMH general association test stratified by donor-recipient relatedness and donor CMV serostatus.|Cochran-Mantel-Haenszel||Odds ratio (ASP0113 vs placebo) and 95% CI was based on CMH general association test stratified by donor-recipient relatedness \& donor CMV serostatus.|Analysis of all-cause mortality and adjudicated CMV EOD. Analysis was completed using the Cochran-Mantel-Haenszel (CMH) test at the 1-sided 5% level stratified by use of antithymocyte globulin (ATG) and by receipt of a kidney from a living or deceased donor.||1.85|0.87|0.205
70982638|NCT01877655|141473838|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.748|TWO_SIDED|95.0|0.76|1.22||P-value based on cox proportional hazards model parameter estimate for the treatment effect.|Cox Proportional Hazard Model|Parameter estimate from cox proportional hazard model (ASP0113 v placebo) with treatment \& randomization strata adjusted for death as a competing risk||Analysis of CMV viremia through 1 year posttransplant. CMV viremia was defined by the protocol as CMV plasma viral load ≥ 1000 IU/mL as assessed by the central laboratory. The 95% CI was based on cumulative incidence function CMV viremia rate at 1 year.||1.22|0.76|0.748
70982639|NCT01877655|141473839|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.888|TWO_SIDED|95.0|0.8|1.29||P-value based on cox proportional hazards model parameter estimate for the treatment effect.|Cox Proportional Hazard Model|Parameter estimate from cox proportional hazard model (ASP0113 v placebo) with treatment \& randomization strata adjusted for death as a competing risk||Analysis of CMV-specific antiviral therapy (AVT) through 1 year. Time to first adjudicated CMV-specific therapy was defined as time to the start of AVT for CMV viremia. CMV-specific AVT was determined by the adjudication committee. Rate was based on cumulative incidence function estimate at 1 year.||1.29|0.80|0.888
70982640|NCT01877655|141473840|SUPERIORITY||Odds Ratio (OR)|1.05||||0.802|TWO_SIDED|95.0|0.73|1.51||P value based on CMH general association test stratified by donor-recipient relatedness and donor CMV serostatus.|Cochran-Mantel-Haenszel||Odds ratio (ASP0113 vs placebo) and 95% CI based on CMH general association test stratified by donor recipient relatedness and donor CMV serostatus.|Analysis of composite of CMV viremia and adjudicated CMV-AVT. The CMV viremia was defined by the protocol as CMV plasma viral load ≥ 1000 IU/mL as assessed by the central laboratory. CMV-specific AVT was determined by the adjudication committee. Participants with no posttransplant viral load data were excluded from the analysis.||1.51|0.73|0.802
71036614|NCT03480763|141581594|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.77|1.17||||||Serotype 33F (Unique to V114)||1.17|0.77|
70982641|NCT01877655|141473841|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.928|TWO_SIDED|95.0|0.8|1.28||P value based on cox proportional hazards model parameter estimate for the treatment effect.|Cox Proportional Hazards Model|Parameter estimate from cox proportional hazard model (ASP0113 v placebo) with treatment \& randomization strata adjusted for death as a competing risk||Analysis of rate of adjudicated CMV AVT or CMV EOD. Time to first CMV-specific AVT was defined as time to the start of AVT for CMV viremia or CMV EOD. CMV-specific AVT and EOD and were determined by the adjudication committee. Rate based on cumulative incidence function estimate at 1 year.||1.28|0.80|0.928
70982642|NCT01877655|141473842|SUPERIORITY||Odds Ratio (OR)|1.18||||0.393|TWO_SIDED|95.0|0.81|1.73||P value based on cox proportional hazards model parameter estimate for the treatment effect.|Cox Proportional Hazards Model||Odds ratio (ASP0113 vs placebo) and 95% CI based on CMH general association test stratified by donor-recipient relatedness and donor CMV serostatus.|Analysis of all-cause mortality at 1 year. Participants with unknown survival status at 1 year were considered dead for this analysis.||1.73|0.81|0.393
70982643|NCT03439345|141473861|SUPERIORITY|For the time-to-event analyses, survival analytic methods will be used to evaluate the time to the first event during the entire study period. Cox proportional hazards regression analyses, adjusted for baseline covariates used in minimised randomisation, will be used to estimate the hazard ratios, 95% confidence intervals and corresponding p-values, comparing all participants allocated active fenofibrate with all those allocated placebo.|Hazard Ratio (HR)|0.73||||0.006|TWO_SIDED|95.0|0.58|0.91|||Regression, Cox|Adjusted for baseline covariates used in minimised randomisation.||||0.91|0.58|0.006
70982644|NCT03439345|141473862|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.72||||0.005|TWO_SIDED|95.0|0.57|0.91|||Regression, Cox|||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.91|0.57|0.005
70982645|NCT03439345|141473863|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.58||||0.08|TWO_SIDED|95.0|0.31|1.06|||Regression, Cox|||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.06|0.31|0.08
70982646|NCT03439345|141473864|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.74||||0.003|TWO_SIDED|95.0|0.61|0.9|||Regression, Cox|||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.90|0.61|0.003
71036615|NCT03480763|141581595|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.92|||||TWO_SIDED|95.0|0.79|1.07||||||Serotype 1 (Shared)||1.07|0.79|
70982647|NCT03439345|141473865|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.66||||0.001|TWO_SIDED|95.0|0.52|0.85|||Regression, Cox|||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.85|0.52|0.001
70982648|NCT03439345|141473866|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.5||||0.008|TWO_SIDED|95.0|0.3|0.84|||Regression, Cox|||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.84|0.30|0.008
70982649|NCT03439345|141473867|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation and for the baseline visual acuity.|Mean Difference (Final Values)|0.0||||0.36|TWO_SIDED|95.0|-0.01|0.01|||Regression, Cox|||The estimates were derived from linear mixed model repeated measures.||0.01|-0.01|0.36
70982650|NCT03439345|141473868|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation and for baseline VFQ-25 composite score.|Mean Difference (Final Values)|0.0||||0.58|TWO_SIDED|95.0|-1.0|1.0|||Regression, Cox|||The estimates were derived from linear mixed model repeated measures.||1|-1|0.58
70982651|NCT03439345|141473869|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation and for baseline EQ-5D Index Score.|Mean Difference (Final Values)|0.0||||0.93|TWO_SIDED|95.0|-0.02|0.02|||Regression, Cox|||The estimates were derived from linear mixed model repeated measures.||0.02|-0.02|0.93
70982652|NCT03439345|141473870|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation and for baseline EQ-5D Visual Analogue Score.|Mean Difference (Final Values)|-1.0||||0.43|TWO_SIDED|95.0|-2.0|1.0|||Regression, Cox|||The estimates were derived from a linear mixed model repeated measures||1|-2|0.43
70982653|NCT03439345|141473871|OTHER||Mean Difference (Final Values)|-254.0|||||TWO_SIDED|95.0|-1062.0|624.0||||||||624|-1062|
70982654|NCT03439345|141473872|OTHER||Incremental cost-effectiveness ratio|614.0|||||TWO_SIDED||||||||£614 cost per QALY gained based on probabilistic analysis|||||
70982655|NCT03439345|141473873|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.58|0.99||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.99|0.58|
70982656|NCT03439345|141473874|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.4|1.0||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.00|0.40|
71036616|NCT03480763|141581595|OTHER|GMC ratio and 95% CI are estimated from a cLDA model|GMC Ratio|1.0|||||TWO_SIDED|95.0|0.87|1.16||||||Serotype 3 (Shared)||1.16|0.87|
71036617|NCT03480763|141581595|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.87|||||TWO_SIDED|95.0|0.74|1.02||||||Serotype 4 (Shared)||1.02|0.74|
71036618|NCT03480763|141581595|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.99|||||TWO_SIDED|95.0|0.84|1.18||||||Serotype 5 (Shared)||1.18|0.84|
70982657|NCT03439345|141473875|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.52|0.97||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.97|0.52|
70982658|NCT03439345|141473876|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.55|1.07||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.07|0.55|
70982659|NCT03439345|141473877|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.51|1.21||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.21|0.51|
70982660|NCT03439345|141473878|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.54|0.93||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.93|0.54|
70982661|NCT03439345|141473879|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.28|0.93||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.93|0.28|
70982662|NCT03439345|141473880|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.6|0.99||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.99|0.60|
70982663|NCT03439345|141473881|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.49|0.95||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.95|0.49|
70982664|NCT03439345|141473882|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.53|1.06||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.06|0.53|
70982665|NCT03439345|141473883|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|1.4|||||TWO_SIDED|95.0|0.55|3.57||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||3.57|0.55|
70982666|NCT03439345|141473884|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.48|1.03||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.03|0.48|
70982667|NCT03439345|141473885|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.56|0.99||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.99|0.56|
70982668|NCT03439345|141473886|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation and for the baseline UACR.|Hazard Ratio (HR)|-12.4|||||TWO_SIDED|95.0|-25.8|3.5|||||Estimates are in %.|Linear mixed model repeated measures analyses were conducted to estimate the trial-averaged percentage difference in geometric mean UACR between the randomised treatment groups. UACR data at baseline was available for 312 participants allocated fenofibrate and 310 participants allocated placebo.||3.5|-25.8|
71036619|NCT03480763|141581595|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.16|||||TWO_SIDED|95.0|0.96|1.41||||||Serotype 6A (Shared)||1.41|0.96|
71036620|NCT03480763|141581595|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.16|||||TWO_SIDED|95.0|0.96|1.4||||||Serotype 6B (Shared)||1.40|0.96|
71036621|NCT03480763|141581595|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.99|||||TWO_SIDED|95.0|0.85|1.16||||||Serotype 7F (Shared)||1.16|0.85|
71036622|NCT03480763|141581595|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.04|||||TWO_SIDED|95.0|0.89|1.22||||||Serotype 9V (Shared)||1.22|0.89|
71036623|NCT03480763|141581595|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.17|||||TWO_SIDED|95.0|0.98|1.39||||||Serotype 14 (Shared)||1.39|0.98|
71036624|NCT03480763|141581595|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.16|||||TWO_SIDED|95.0|1.0|1.36||||||Serotype 18C (Shared)||1.36|1.00|
71036625|NCT03480763|141581595|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.1|||||TWO_SIDED|95.0|0.95|1.29||||||Serotype 19A (Shared)||1.29|0.95|
71036626|NCT03480763|141581595|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.09|||||TWO_SIDED|95.0|0.93|1.27||||||Serotype 19F (Shared)||1.27|0.93|
71036627|NCT03480763|141581595|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.14|||||TWO_SIDED|95.0|0.96|1.35||||||Serotype 23F (Shared)||1.35|0.96|
71036628|NCT03480763|141581595|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.43|||||TWO_SIDED|95.0|1.16|1.77||||||Serotype 22F (Unique to V114)||1.77|1.16|
71036629|NCT03480763|141581595|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.8|||||TWO_SIDED|95.0|0.67|0.95||||||Serotype 33F (Unique to V114)||0.95|0.67|
71036630|NCT03480763|141581596|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.22|||||TWO_SIDED|95.0|0.94|1.58||||||Serotype 1 (Shared)||1.58|0.94|
71036631|NCT03480763|141581596|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.9|||||TWO_SIDED|95.0|1.56|2.3||||||Serotype 3 (Shared)||2.30|1.56|
70982669|NCT03439345|141473887|SUPERIORITY|"Adjusted for baseline covariates used in minimised randomisation.~."|Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.69|1.6||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.60|0.69|
70982670|NCT03439345|141473888|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.35|||||TWO_SIDED|95.0|0.11|1.12||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.12|0.11|
70982671|NCT02128490|141473908|SUPERIORITY_OR_OTHER||Difference in Proportions|35.9|||<|0.001|TWO_SIDED|95.0|20.8|51.0|||Fisher Exact|||||51.0|20.8|<0.001
70982672|NCT02128490|141473908|SUPERIORITY_OR_OTHER||Difference in Proportions|44.7|||<|0.001|TWO_SIDED|95.0|28.9|60.5|||Fisher Exact|||||60.5|28.9|<0.001
70982673|NCT02128490|141473908|SUPERIORITY_OR_OTHER||Difference in Proportions|22.4||||0.034|TWO_SIDED|95.0|3.7|41.0|||Fisher Exact|||||41.0|3.7|0.034
70982674|NCT02128490|141473908|SUPERIORITY_OR_OTHER||Difference in Proportions|4.2||||0.817|TWO_SIDED|95.0|-18.2|26.6|||Fisher Exact|||||26.6|-18.2|0.817
70982675|NCT02128490|141473909|SUPERIORITY_OR_OTHER||Difference in Proportions|12.6||||0.224|TWO_SIDED|95.0|-3.9|29.0|||Fisher Exact|||||29.0|-3.9|0.224
70982676|NCT02128490|141473909|SUPERIORITY_OR_OTHER||Difference in Proportions|31.6||||0.004|TWO_SIDED|95.0|13.1|50.1|||Fisher Exact|||||50.1|13.1|0.004
70982677|NCT02128490|141473909|SUPERIORITY_OR_OTHER||Difference in Proportions|-17.5||||0.139|TWO_SIDED|95.0|-38.1|3.2|||Fisher Exact|||||3.2|-38.1|0.139
70982678|NCT02128490|141473909|SUPERIORITY_OR_OTHER||Difference in Proportions|4.3||||0.815|TWO_SIDED|95.0|-17.9|26.4|||Fisher Exact|||||26.4|-17.9|0.815
70982679|NCT02128490|141473910|SUPERIORITY_OR_OTHER||Difference in Proportions|53.8|||<|0.001|TWO_SIDED|95.0|38.2|69.5|||Fisher Exact|||||69.5|38.2|<0.001
70982680|NCT02128490|141473910|SUPERIORITY_OR_OTHER||Difference in Proportions|55.3|||<|0.001|TWO_SIDED|95.0|39.5|71.1|||Fisher Exact|||||71.1|39.5|<0.001
70982681|NCT02128490|141473910|SUPERIORITY_OR_OTHER||Difference in Proportions|21.4||||0.069|TWO_SIDED|95.0|-0.3|43.1|||Fisher Exact|||||43.1|-0.3|0.069
70982682|NCT02128490|141473910|SUPERIORITY_OR_OTHER||Difference in Proportions|-4.2||||0.817|TWO_SIDED|95.0|-26.6|18.2|||Fisher Exact|||||18.2|-26.6|0.817
71008536|NCT02140762|141525115|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|10.9|||||TWO_SIDED|||||||||Vaccine effectiveness\<60% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
70982683|NCT02243176|141473911|NON_INFERIORITY_OR_EQUIVALENCE|With a total sample size of 480 patients randomized and an expected drop-out rate of 20%, the trial will be powered at 90% to establish non-inferiority for the primary endpoint, at a one-sided alpha level of 0.025, with the non-inferiority margin of 0.4%, assuming the true effects are the same between treatments. The calculation is also based on the assumption that the standard deviation for the change in HbA1c is 1.2%.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.09||0.6236|TWO_SIDED|95.0|-0.22|0.13||This p value is for the hypothesis of superiority|Mixed Model Repeated Measures||Mean difference=Saxagliptin - Acarbose|"H01: μS-μA≥ 0.4% vs Ha1: μS-μA\< 0.4%. Null hypothesis will be rejected if the upper limit of 2-sided 95% CI is below 0.4%.If the null hypothesis above (H01) is rejected, the following hypothesis will be tested to further establish superiority:~H02: μS-μA≥ 0 vs Ha2: μS-μA\< 0. This null hypothesis (H02) will be rejected if the upper limit of 2-sided 95% CI is below 0."||0.13|-0.22|0.6236
70982684|NCT02243176|141473912|NON_INFERIORITY_OR_EQUIVALENCE|With a total sample size of 480 patients randomized and an expected drop-out rate of 20%, the trial will be powered at 90% to establish non-inferiority for the primary endpoint, at a one-sided alpha level of 0.025, with the non-inferiority margin of 0.4%, assuming the true effects are the same between treatments. The calculation is also based on the assumption that the standard deviation for the change in HbA1c is 1.2%.|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.09||0.7809|TWO_SIDED|95.0|-0.21|0.15||This p value is for the hypothesis of superiority|Mixed Model Repeated Measures||Mean difference=Saxagliptin - Acarbose|"H01: μS-μA≥ 0.4% vs Ha1: μS-μA\< 0.4%. Null hypothesis will be rejected if the upper limit of 2-sided 95% CI is below 0.4%.If the null hypothesis above (H01) is rejected, the following hypothesis will be tested to further establish superiority:~H02: μS-μA≥ 0 vs Ha2: μS-μA\< 0. This null hypothesis (H02) will be rejected if the upper limit of 2-sided 95% CI is below 0."||0.15|-0.21|0.7809
70982685|NCT02243176|141473913|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.22|||<|0.0001|TWO_SIDED|95.0|0.12|0.39|||Cochran-Mantel-Haenszel|Stratefied by the baseline disease severity (HbA1c \< 8.0% and ≥ 8.0%)|RR = Saxagliptin/Acarbose|||0.39|0.12|<0.0001
70982686|NCT02243176|141473914|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92||||0.5044|TWO_SIDED|95.0|0.74|1.15|||Cochran-Mantel-Haenszel|stratefied by baseline disease severity (HbA1c\<8%, \>=8%)||||1.15|0.74|0.5044
70982687|NCT02243176|141473915|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.28||||0.0518|TWO_SIDED|95.0|0.98|1.67|||Cochran-Mantel-Haenszel|Stratefied by the baseline disease severity (HbA1c \< 8.0% and ≥ 8.0%)|RR = Saxagliptin/Acarbose|||1.67|0.98|0.0518
70982688|NCT02243176|141473916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.18||0.8915|TWO_SIDED|95.0|-0.33|0.38|||Mixed Model Repeated Measures||Mean difference=Saxagliptin - Acarbose|||0.38|-0.33|0.8915
70982689|NCT02243176|141473917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.249||0.2248|TWO_SIDED|95.0|-0.186|0.791|||ANCOVA||Mean difference=Saxagliptin - Acarbose|||0.791|-0.186|0.2248
70982690|NCT02243176|141473918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.48|STANDARD_ERROR_OF_MEAN|8.407||0.3739|TWO_SIDED|95.0|-9.039|24.005|||ANCOVA||Mean difference=Saxagliptin - Acarbose|||24.005|-9.039|0.3739
70982691|NCT02243176|141473919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.26||0.0078|TWO_SIDED|95.0|0.18|1.19|||Mixed Model Repeated Measures||Mean difference=Saxagliptin - Acarbose|||1.19|0.18|0.0078
70982692|NCT03704051|141473926|EQUIVALENCE|A priori power analysis based on pilot testing with 12 dyads indicated that a sample size of at least 40 dyads would provide 80% power to detect significant within-subjects (condition, i.e., breastfeeding directly from the breast vs. bottle-feeding expressed breast milk) effects at an α = 0.05 Type I error level.||||||0.634|||||||Mixed Models Analysis|All models adjusted for order of conditions, time since last feeding and infant age.||||||0.634
70982693|NCT03704051|141473927|EQUIVALENCE|A priori power analysis based on pilot testing with 12 dyads indicated that a sample size of at least 40 dyads would provide 80% power to detect significant within-subjects (condition, i.e., breastfeeding directly from the breast vs. bottle-feeding expressed breast milk) effects at an α = 0.05 Type I error level.||||||0.115|||||||Mixed Models Analysis|All models adjusted for order of conditions, time since last feeding and infant age.||||||0.115
70982694|NCT03440112|141473952|SUPERIORITY||Chi-Squared|3.0039||||0.391|TWO_SIDED||||||Mixed Models Analysis|||A pair of random-intercept mixed linear models was fitted, a visit model and an interaction model. Visit model included fixed effect of visit and a random intercept by participant. Interaction model adds an interaction by treatment term on top of the visit model. Null hypothesis is that visit by treatment interaction does not explain significant additional variance in clinical outcome scores. Likelihood ratio test comparing the interaction model to the visit model was used to derive a p-value.||||0.391
70982695|NCT03440112|141473953|SUPERIORITY||Chi-Squared|9.4836||||0.02351|TWO_SIDED||||||Mixed Models Analysis|||A pair of random-intercept mixed linear models was fitted, a visit model and an interaction model. Visit model included fixed effect of visit and a random intercept by participant. Interaction model adds an interaction by treatment term on top of the visit model. Null hypothesis is that visit by treatment interaction does not explain significant additional variance in clinical outcome scores. Likelihood ratio test comparing the interaction model to the visit model was used to derive a p-value.||||0.02351
70982696|NCT01943539|141473954|SUPERIORITY||Effect Size|0.62||||0.008|TWO_SIDED||||||t-test, 2 sided|||||||0.008
71036632|NCT03480763|141581596|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|0.76|||||TWO_SIDED|95.0|0.6|0.97||||||Serotype 4 (Shared)||0.97|0.60|
70982697|NCT02413255|141473966|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0195||||0.465|TWO_SIDED|90.0|0.9752|1.0637|||Power Model|||||1.0637|0.9752|0.465
70982698|NCT02413255|141473967|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.1124||||0.126|TWO_SIDED|90.0|0.9913|1.2336|||Power Model|||Day 1||1.2336|0.9913|0.126
70982699|NCT02413255|141473967|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.09||||0.114|TWO_SIDED|90.0|0.9962|1.1838|||Power Model|||Day 9||1.1838|0.9962|0.114
70982700|NCT02413255|141473968|SUPERIORITY|||||||0.5402|||||||ANOVA|Statistical analysis results were obtained using Analysis of Variance (ANOVA) with dose level as a fixed effect.||||||0.5402
70982701|NCT02413255|141473969|SUPERIORITY|||||||0.7824|||||||ANOVA|Statistical analysis results were obtained using ANOVA with dose level as a fixed effect.||Day 1||||0.7824
70982702|NCT02413255|141473969|SUPERIORITY|||||||0.4056|||||||ANOVA|Statistical analysis results were obtained using ANOVA with dose level as a fixed effect.||Day 9||||0.4056
71036633|NCT03480763|141581596|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.07|||||TWO_SIDED|95.0|0.81|1.4||||||Serotype 5 (Shared)||1.40|0.81|
70982703|NCT02413255|141473970|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0606||||0.019|TWO_SIDED|90.0|1.0187|1.1026|||Power Model|||||1.1026|1.0187|0.019
70982704|NCT02413255|141473971|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0789||||0.258|TWO_SIDED|90.0|0.9628|1.195|||Power Model|||Day 1||1.1950|0.9628|0.258
70982705|NCT02413255|141473971|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0929||||0.144|TWO_SIDED|90.0|0.9878|1.198|||Power Model|||Day 9||1.1980|0.9878|0.144
70982706|NCT02413255|141473974|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0799||||0.003|TWO_SIDED|90.0|1.0371|1.1227|||Power Model|||||1.1227|1.0371|0.003
70982707|NCT02413255|141473975|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0897||||0.201|TWO_SIDED|90.0|0.9735|1.206|||Power Model|||||1.2060|0.9735|0.201
70982708|NCT02413255|141473976|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0188||||0.49|TWO_SIDED|90.0|0.9734|1.0642|||Power Model|||||1.0642|0.9734|0.490
70982709|NCT02413255|141473977|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0846||||0.224|TWO_SIDED|90.0|0.969|1.2002|||Power Model|||||1.2002|0.9690|0.224
70982710|NCT02413255|141473984|SUPERIORITY||||||<|0.0001|||||||ANOVA|Statistical analysis results were obtained using ANOVA with dose level as a fixed effect.||||||<.0001
70982711|NCT02413255|141474000|OTHER||Estimated Ratio|1.121|||||TWO_SIDED|90.0|0.772|1.628||||||||1.628|0.772|
70982712|NCT02413255|141474000|OTHER||Estimated Ratio|1.156|||||TWO_SIDED|90.0|0.796|1.678||||||||1.678|0.796|
70982713|NCT02413255|141474000|OTHER||Estimated Ratio|0.982|||||TWO_SIDED|90.0|0.676|1.425||||||||1.425|0.676|
70982714|NCT02413255|141474000|OTHER||Estimated Ratio|1.055|||||TWO_SIDED|90.0|0.701|1.587||||||||1.587|0.701|
70982715|NCT02413255|141474000|OTHER||Estimated Ratio|1.105|||||TWO_SIDED|90.0|0.761|1.604||||||||1.604|0.761|
70982716|NCT02413255|141474000|OTHER||Estimated Ratio|1.225|||||TWO_SIDED|90.0|0.844|1.778||||||||1.778|0.844|
70982717|NCT02333331|141474001|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.274|TWO_SIDED|95.0|-0.64|1.21|||Mixed Models Analysis|||||1.21|-0.64|0.274
70982718|NCT02333331|141474001|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.32|TWO_SIDED|95.0|-0.83|1.35|||Mixed Models Analysis|||||1.35|-0.83|0.320
70982719|NCT02333331|141474001|SUPERIORITY||Mean Difference (Final Values)|0.31||||0.134|TWO_SIDED|95.0|-0.24|0.87|||Mixed Models Analysis|||||0.87|-0.24|0.134
70982720|NCT02333331|141474002|SUPERIORITY||Mean Difference (Final Values)|-3.32||||0.576|TWO_SIDED|95.0|-37.6|30.95|||Mixed Models Analysis|||||30.95|-37.6|0.576
70982721|NCT02333331|141474002|SUPERIORITY||Mean Difference (Final Values)|19.6||||0.178|TWO_SIDED|95.0|-22.2|61.41|||Mixed Models Analysis|||||61.41|-22.2|0.178
70982722|NCT02333331|141474002|SUPERIORITY||Mean Difference (Final Values)|10.31||||0.163|TWO_SIDED|95.0|-10.4|30.98|||Mixed Models Analysis|||||30.98|-10.4|0.163
71036634|NCT03480763|141581596|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.19|||||TWO_SIDED|95.0|0.92|1.53||||||Serotype 6A (Shared)||1.53|0.92|
71036635|NCT03480763|141581596|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.64|||||TWO_SIDED|95.0|1.31|2.06||||||Serotype 6B (Shared)||2.06|1.31|
71036636|NCT03480763|141581596|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.8|1.14||||||Serotype 7F (Shared)||1.14|0.80|
71036637|NCT03480763|141581596|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.83|1.24||||||Serotype 9V (Shared)||1.24|0.83|
71036638|NCT03480763|141581596|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.09|||||TWO_SIDED|95.0|0.87|1.37||||||Serotype 14 (Shared)||1.37|0.87|
71036639|NCT03480763|141581596|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.48|||||TWO_SIDED|95.0|1.2|1.84||||||Serotype 18C (Shared)||1.84|1.20|
71036640|NCT03480763|141581596|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.28|||||TWO_SIDED|95.0|1.06|1.55||||||Serotype 19A (Shared)||1.55|1.06|
71097278|NCT05103332|141703603|SUPERIORITY||Difference in LS Mean|-4.5|STANDARD_ERROR_OF_MEAN|1.14|<|0.0001|TWO_SIDED|95.0|-6.8|-2.3||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to olmesartan) and placebo (add on to olmesartan), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05. All collected data for office SBP were included in the analysis for this endpoint.||-2.3|-6.8|<0.0001
71097279|NCT05103332|141703604|SUPERIORITY||Odds Ratio (OR)|1.67|||=|0.123|TWO_SIDED|95.0|0.87|3.23||Logistic regression model included treatment and race (black or all other races) as factors and baseline 24-hour mean SBP and baseline eGFR as covariates.|Regression, Logistic|||A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05.||3.23|0.87|=0.1230
71097280|NCT01740427|141703621|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.576|||<|1e-06|TWO_SIDED|95.0|0.463|0.718||1-sided p-value from the stratified log-rank test.|Stratified Log Rank|||||0.718|0.463|<0.000001
70982723|NCT02333331|141474003|SUPERIORITY||Mean Difference (Net)|0.0||||0.488|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||||0.10|-0.10|0.488
70982724|NCT02333331|141474003|SUPERIORITY||Mean Difference (Net)|0.1||||0.055|TWO_SIDED|95.0|-0.02|0.22|||Mixed Models Analysis|||||0.22|-0.02|0.055
70982725|NCT02333331|141474003|SUPERIORITY||Mean Difference (Net)|0.03||||0.161|TWO_SIDED|95.0|-0.03|0.09|||Mixed Models Analysis|||||0.09|-0.03|0.161
70982726|NCT02333331|141474004|SUPERIORITY||Mean Difference (Net)|1.01||||0.213|TWO_SIDED|95.0|0.99|1.03|||Mixed Models Analysis|||||1.03|0.99|0.213
70982727|NCT02333331|141474004|SUPERIORITY||Mean Difference (Net)|1.06|||<|0.001|TWO_SIDED|95.0|1.03|1.09|||Mixed Models Analysis|||||1.09|1.03|<0.001
70982728|NCT02333331|141474004|SUPERIORITY||Mean Difference (Net)|1.06|||<|0.001|TWO_SIDED|95.0|1.05|1.08|||Mixed Models Analysis|||||1.08|1.05|<0.001
70982729|NCT02333331|141474005|SUPERIORITY||Mean Difference (Net)|1.0||||0.458|TWO_SIDED|95.0|0.98|1.02|||Mixed Models Analysis|||||1.02|0.98|0.458
70982730|NCT02333331|141474005|SUPERIORITY||Mean Difference (Net)|1.05|||<|0.001|TWO_SIDED|95.0|1.03|1.08|||Mixed Models Analysis|||||1.08|1.03|<0.001
70982731|NCT02333331|141474005|SUPERIORITY||Mean Difference (Net)|1.06|||<|0.001|TWO_SIDED|95.0|1.04|1.07|||Mixed Models Analysis|||||1.07|1.04|<0.001
70982732|NCT03815292|141474032|SUPERIORITY|||||||0.02|||||||Fisher Exact|||||||0.02
70982733|NCT03815292|141474033|SUPERIORITY|||||||0.0445|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and after 24 weeks total scores row.||||0.0445
70982734|NCT03815292|141474034|SUPERIORITY|||||||0.0345|||||||Fisher Exact|||||||0.0345
70982735|NCT03815292|141474035|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and after 24 weeks total scores row.||||0.04
70982736|NCT03815292|141474036|SUPERIORITY|||||||0.0016|||||||t-test, 2 sided|||This analysis applies to ∆ between baseline and after 24 weeks total scores row.||||0.0016
70982737|NCT03815292|141474037|SUPERIORITY|||||||0.0054|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to Therapeutic effect row.||||0.0054
70982738|NCT03815292|141474037|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to Side effects row.||||0.78
70982739|NCT03815292|141474037|SUPERIORITY|||||||0.0042|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to Efficiency index row.||||0.0042
70982740|NCT03815292|141474038|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between 24 and 28 weeks total scores row.||||0.77
70982741|NCT03815292|141474039|SUPERIORITY|||||||0.0118|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between 24 and 28 weeks total scores row.||||0.0118
70982742|NCT03815292|141474040|SUPERIORITY|||||||0.058|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between 24 and 28 weeks total scores row.||||0.058
70982743|NCT04243369|141474044|OTHER|Only descriptive statistics was provided. The rate and the exact 95% CI of the rate using the Clopper-Pearson Exact method is calculated.|Rate|100.0|||||TWO_SIDED|95.0|88.4|100.0||||||||100|88.4|
70982744|NCT03230097|141474115|OTHER||Hazard Ratio (HR)|0.849||||0.7873|TWO_SIDED|95.0|0.258|2.795|||Regression, Cox|Stratified (by baseline use of antipsychotic medication) Cox proportional hazards model was used. Treatment effect and NAPLS risk score as covariates.|Ratio = BI 409306/placebo.|||2.795|0.258|0.7873
71008788|NCT02055976|141525255|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.01501|STANDARD_ERROR_OF_MEAN|0.16217|<|0.001|TWO_SIDED|95.0|-2.33718|-1.69283|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.69283|-2.33718|<0.001
70982745|NCT03230097|141474117|OTHER||Adjusted mean difference|1.77||||0.5212|TWO_SIDED|95.0|-3.773|7.315|||Mixed Models Analysis|||BI 409306 vs. placebo of change from baseline at week 24. Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM) including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline North American Prodromal Longitudinal Study (NAPLS) risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction.||7.315|-3.773|0.5212
70982746|NCT03230097|141474117|OTHER||Adjusted mean difference|3.18||||0.3127|TWO_SIDED|95.0|-3.071|9.425|||Mixed Models Analysis||Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM), see endpoint description for details.|BI 409306 vs. placebo of change from baseline at week 52. Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM) including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline North American Prodromal Longitudinal Study (NAPLS) risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction.||9.425|-3.071|0.3127
70982747|NCT03230097|141474118|OTHER||Adjusted mean difference|-4.99||||0.1602|TWO_SIDED|95.0|-12.033|2.057|||Mixed Models Analysis|||BI 409306 vs. placebo of change from baseline at week 52. Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM) including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline North American Prodromal Longitudinal Study (NAPLS) risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction.||2.057|-12.033|0.1602
71036641|NCT03480763|141581596|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.92|1.32||||||Serotype 19F (Shared)||1.32|0.92|
71036642|NCT03480763|141581596|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.53|||||TWO_SIDED|95.0|1.18|2.0||||||Serotype 23F (Shared)||2.00|1.18|
71036643|NCT03480763|141581596|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|34.86|||||TWO_SIDED|95.0|26.13|46.5||||||Serotype 22F (Unique to V114)||46.50|26.13|
71036644|NCT03480763|141581596|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|9.15|||||TWO_SIDED|95.0|7.48|11.2||||||Serotype 33F (Unique to V114)||11.20|7.48|
71036645|NCT03480763|141581597|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.89|||||TWO_SIDED|95.0|0.72|1.09||||||Serotype 1 (Shared)||1.09|0.72|
71036646|NCT03480763|141581597|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.74|||||TWO_SIDED|95.0|1.46|2.07||||||Serotype 3 (Shared)||2.07|1.46|
71036647|NCT03480763|141581597|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.64|0.99||||||Serotype 4 (Shared)||0.99|0.64|
71036648|NCT03480763|141581597|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.04|||||TWO_SIDED|95.0|0.84|1.3||||||Serotype 5 (Shared)||1.30|0.84|
71036649|NCT03480763|141581597|OTHER|GMCs, GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.4|||||TWO_SIDED|95.0|1.1|1.77||||||Serotype 6A (Shared)||1.77|1.10|
71036650|NCT03480763|141581597|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.64|||||TWO_SIDED|95.0|1.28|2.1||||||Serotype 6B (Shared)||2.10|1.28|
71036651|NCT03480763|141581597|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.91|||||TWO_SIDED|95.0|0.74|1.13||||||Serotype 7F (Shared)||1.13|0.74|
71036652|NCT03480763|141581597|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.13|||||TWO_SIDED|95.0|0.91|1.41||||||Serotype 9V (Shared)||1.41|0.91|
71036653|NCT03480763|141581597|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.09|||||TWO_SIDED|95.0|0.87|1.38||||||Serotype 14 (Shared)||1.38|0.87|
71036654|NCT03480763|141581597|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.56|||||TWO_SIDED|95.0|1.27|1.92||||||Serotype 18C (Shared)||1.92|1.27|
71036655|NCT03480763|141581597|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.13|||||TWO_SIDED|95.0|0.91|1.39||||||Serotype 19A (Shared)||1.39|0.91|
71036656|NCT03480763|141581597|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.14|||||TWO_SIDED|95.0|0.92|1.41||||||Serotype 19F (Shared)||1.41|0.92|
71036657|NCT03480763|141581597|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.61|||||TWO_SIDED|95.0|1.27|2.04||||||Serotype 23F (Shared)||2.04|1.27|
71036658|NCT03480763|141581597|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|16.54|||||TWO_SIDED|95.0|13.78|19.86||||||Serotype 22F (Unique to V114)||19.86|13.78|
71036659|NCT03480763|141581597|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|12.82|||||TWO_SIDED|95.0|10.82|15.19||||||Serotype 33F (Unique to V114)||15.19|10.82|
71036660|NCT03480763|141581602|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.19|||||TWO_SIDED|95.0|0.92|1.53||||||Serotype 1 (Shared)||1.53|0.92|
71036661|NCT03480763|141581602|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.57|||||TWO_SIDED|95.0|1.29|1.9||||||Serotype 3 (Shared)||1.90|1.29|
71036662|NCT03480763|141581602|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|0.72|||||TWO_SIDED|95.0|0.57|0.9||||||Serotype 4 (Shared)||0.90|0.57|
71036663|NCT03480763|141581602|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.78|1.33||||||Serotype 5 (Shared)||1.33|0.78|
71036664|NCT03480763|141581602|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.15|||||TWO_SIDED|95.0|0.93|1.41||||||Serotype 6A (Shared)||1.41|0.93|
71036665|NCT03480763|141581602|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.43|||||TWO_SIDED|95.0|1.16|1.77||||||Serotype 6B (Shared)||1.77|1.16|
71036666|NCT03480763|141581602|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|0.94|||||TWO_SIDED|95.0|0.8|1.11||||||Serotype 7F (Shared)||1.11|0.80|
71036667|NCT03480763|141581602|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|0.98|||||TWO_SIDED|95.0|0.81|1.18||||||Serotype 9V (Shared)||1.18|0.81|
71036668|NCT03480763|141581602|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.11|||||TWO_SIDED|95.0|0.9|1.36||||||Serotype 14 (Shared)||1.36|0.90|
71036669|NCT03480763|141581602|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.28|||||TWO_SIDED|95.0|1.05|1.55||||||Serotype 18C (Shared)||1.55|1.05|
70982748|NCT03230097|141474119|OTHER||Adjusted mean difference|-0.8||||0.5858|TWO_SIDED|95.0|-3.749|2.153|||Mixed Models Analysis|||BI 409306 vs. placebo of change from baseline at week 52, positive items score. Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM) including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline North American Prodromal Longitudinal Study (NAPLS) risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction.||2.153|-3.749|0.5858
70982749|NCT03230097|141474119|OTHER||Adjusted mean difference|1.43||||0.3445|TWO_SIDED|95.0|-1.604|4.462|||Mixed Models Analysis|||BI 409306 vs. placebo of change from baseline at week 52, negative items score. Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM) including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline North American Prodromal Longitudinal Study (NAPLS) risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction.||4.462|-1.604|0.3445
70982750|NCT03230097|141474119|OTHER||Adjusted mean difference|1.71||||0.7154|TWO_SIDED|95.0|-7.772|11.196|||Mixed Models Analysis|||BI 409306 vs. placebo of change from baseline at week 52, total score. Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM) including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline North American Prodromal Longitudinal Study (NAPLS) risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction.||11.196|-7.772|0.7154
70982751|NCT05370157|141474120|SUPERIORITY||Mean Difference (Net)|4.25|STANDARD_ERROR_OF_MEAN|0.85||0.03|TWO_SIDED|95.0|0.76|7.74|||Regression, Linear|Satterthwaite Approximation||Intent-to-treat analyses tested changes in knowledge from baseline to follow-up using linear mixed models. Mixed models analyses were conducted in R using the lme4 package and restricted maximum likelihood estimation (REML). Models included fixed effects of time (baseline vs. follow-up), intervention condition, and their interaction as well as random effects for person and team. We used the clubSandwich package to calculate cluster robust standard errors.||7.74|0.76|.03
70982752|NCT05370157|141474121|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.3|TWO_SIDED|95.0|-0.4|0.2|||Regression, Linear|Satterthwaite Approximation||Intent-to-treat analyses tested changes in skill use from baseline to follow-up using linear mixed models. Mixed models analyses were conducted in R using the lme4 package and restricted maximum likelihood estimation (REML). Models included fixed effects of time (baseline vs. follow-up), intervention condition, and their interaction as well as random effects for person and team. We used the clubSandwich package to calculate cluster robust standard errors.||0.20|-0.40|.30
70982753|NCT05370157|141474125|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.25||0.45|TWO_SIDED|95.0|-1.25|0.79|||Regression, Linear|||Intent-to-treat analyses tested changes in psychological safety from baseline to follow-up using linear mixed models. Mixed models analyses were conducted in R using the lme4 package and restricted maximum likelihood estimation (REML). Models included fixed effects of time (baseline vs. follow-up), intervention condition, and their interaction as well as random effects for person and team. We used the clubSandwich package to calculate cluster robust standard errors.||0.79|-1.25|.45
70982754|NCT05370157|141474126|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.1||0.89|TWO_SIDED|95.0|-0.44|0.4|||Regression, Linear|||Intent-to-treat analyses tested changes in learning behavior from baseline to follow-up using linear mixed models. Mixed models analyses were conducted in R using the lme4 package and restricted maximum likelihood estimation (REML). Models included fixed effects of time (baseline vs. follow-up), intervention condition, and their interaction as well as random effects for person and team. We used the clubSandwich package to calculate cluster robust standard errors.||0.40|-0.44|.89
71036670|NCT03480763|141581602|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.09|||||TWO_SIDED|95.0|0.91|1.31||||||Serotype 19A (Shared)||1.31|0.91|
71036671|NCT03480763|141581602|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.08|||||TWO_SIDED|95.0|0.91|1.29||||||Serotype 19F (Shared)||1.29|0.91|
70982755|NCT05370157|141474127|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.36||0.85|TWO_SIDED|95.0|-1.51|1.36|||Regression, Linear|||Intent-to-treat analyses tested changes in team performance from baseline to follow-up using linear mixed models. Mixed models analyses were conducted in R using the lme4 package and restricted maximum likelihood estimation (REML). Models included fixed effects of time (baseline vs. follow-up), intervention condition, and their interaction as well as random effects for person and team. We used the clubSandwich package to calculate cluster robust standard errors.||1.36|-1.51|.85
70982756|NCT01144637|141474134|EQUIVALENCE|The equivalence margins to show that the 3 vaccine lots are equivalent in terms of PRNT GMTs at Week 6 was predefined as \[0.5; 2\] for the GMT ratios (pairwise)|GMT ratio (Group 1 / Group 2)|1.1012|||||TWO_SIDED|95.0|0.9992|1.2136||||||||1.2136|0.9992|
70982757|NCT01144637|141474134|EQUIVALENCE|The equivalence margins to show that the 3 vaccine lots are equivalent in terms of PRNT GMTs at Week 6 was predefined as \[0.5; 2\] for the GMT ratios (pairwise)|GMT ratio (Group 1 / Group 3)|0.9444|||||TWO_SIDED|95.0|0.8554|1.0427||||||||1.0427|0.8554|
70982758|NCT01144637|141474134|EQUIVALENCE|The equivalence margins to show that the 3 vaccine lots are equivalent in terms of PRNT GMTs at Week 6 was predefined as \[0.5; 2\] for the GMT ratios (pairwise)|GMT ratio (Group 2 / Group 3)|0.8577|||||TWO_SIDED|95.0|0.7753|0.9488||||||||0.9488|0.7753|
70982759|NCT01364467|141474146|OTHER|||||||0.013|||||||t-test, 2 sided|||||||0.013
70982760|NCT01364467|141474147|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|||||||0.98
70982761|NCT01364467|141474147|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|||||||0.65
70982762|NCT03842137|141474149|SUPERIORITY||Slope|-0.53|STANDARD_ERROR_OF_MEAN|0.19||0.008|TWO_SIDED|95.0|-0.91|-0.15|||Regression, Linear|Utilizing a regression model, baseline craving scores, group condition, and their interaction are regressed on 2-week craving scores.||||-.15|-.91|.008
70982763|NCT03842137|141474150|SUPERIORITY|An ancova model was conducted comparing differences between tDCS and sham on post-stimulation theta burst rate, while controlling for pre-stimulation theta burst rate||||||0.005|||||||ANCOVA|||||||.005
70982764|NCT04322708|141474163|SUPERIORITY||Percent Difference from Placebo|81.6|||<|0.0001|TWO_SIDED|95.0|71.5|89.0|||Fisher Exact|||||89.0|71.5|<0.0001
70982765|NCT04322708|141474163|SUPERIORITY||Percent Difference from Placebo|77.0|||<|0.0001|TWO_SIDED|95.0|66.1|85.4|||Fisher Exact|||||85.4|66.1|<0.0001
70982766|NCT04322708|141474164|SUPERIORITY||LSM Difference from Placebo|2.7||||0.247|TWO_SIDED|95.0|-1.9|7.3|||ANCOVA|||||7.3|-1.9|0.2470
70982767|NCT04322708|141474164|SUPERIORITY||LSM Difference from Placebo|-2.8||||0.2372|TWO_SIDED|95.0|-7.3|1.8|||ANCOVA|||||1.8|-7.3|0.2372
71097281|NCT01740427|141703622|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.428||||0.0224|TWO_SIDED|95.0|1.008|2.03||1-sided p-value is from exact test.|Fisher Exact|||Stratified analysis: Stratified by disease site (visceral vs non-visceral) per randomization.||2.030|1.008|0.0224
71097282|NCT01740427|141703623|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.594||||0.009|TWO_SIDED|95.0|1.08|2.347||1-sided p-value is from exact test.|Fisher Exact|||Stratified analysis: Stratified by disease site (visceral vs non-visceral) per randomization.||2.347|1.080|0.0090
71097283|NCT01740427|141703625|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.451|||<|0.0001|TWO_SIDED|95.0|1.619|3.722||1-sided p-value is from exact test.|Fisher Exact|||Stratified analysis: Stratified by disease site (visceral, non-visceral) per randomization.||3.722|1.619|<0.0001
70982768|NCT04322708|141474165|SUPERIORITY||LSM Difference from Placebo|-95.7|||<|0.0001|TWO_SIDED|95.0|-109.0|-82.4|||ANCOVA|||||-82.4|-109|<0.0001
70982769|NCT04322708|141474165|SUPERIORITY||LSM Difference from Placebo|-96.2|||<|0.0001|TWO_SIDED|95.0|-110.0|-82.5|||ANCOVA|||||-82.5|-110|<0.0001
70982770|NCT04322708|141474166|SUPERIORITY||Percent Difference from Placebo|83.8|||<|0.0001|TWO_SIDED|95.0|74.4|90.8|||Fisher Exact|||||90.8|74.4|<0.0001
70982771|NCT04322708|141474166|SUPERIORITY||Percent Difference from Placebo|80.3|||<|0.0001|TWO_SIDED|95.0|69.8|87.9|||Fisher Exact|||||87.9|69.8|<0.0001
70982772|NCT04322708|141474167|SUPERIORITY||Percent Difference from Placebo|77.3|||<|0.0001|TWO_SIDED|95.0|66.4|85.5|||Fisher Exact|||||85.5|66.4|<0.0001
70982773|NCT04322708|141474167|SUPERIORITY||Percent Difference from Placebo|72.7|||<|0.0001|TWO_SIDED|95.0|61.3|81.9|||Fisher Exact|||||81.9|61.3|<0.0001
70982774|NCT04322708|141474168|SUPERIORITY||Percent Difference from Placebo|36.5|||<|0.0001|TWO_SIDED|95.0|22.9|49.5|||Fisher Exact|||||49.5|22.9|<0.0001
70982775|NCT04322708|141474168|SUPERIORITY||Percent Difference from Placebo|49.5|||<|0.0001|TWO_SIDED|95.0|35.9|61.0|||Fisher Exact|||||61.0|35.9|<0.0001
70982776|NCT04322708|141474169|SUPERIORITY||Percent Difference from Placebo|-4.8||||0.5561|TWO_SIDED|95.0|-19.2|10.0|||Fisher Exact|||||10.0|-19.2|0.5561
71097284|NCT01740427|141703626|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.571|||<|0.0001|TWO_SIDED|95.0|0.443|0.737|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for ER positive||0.737|0.443|<0.0001
71097285|NCT01740427|141703626|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.405||||0.003|TWO_SIDED|95.0|0.218|0.751|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for ER Negative||0.751|0.218|0.0030
71097286|NCT01740427|141703626|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.531|||<|0.0001|TWO_SIDED|95.0|0.416|0.68|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Rb Positive||0.680|0.416|<0.0001
71097287|NCT01740427|141703626|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.675||||0.3237|TWO_SIDED|95.0|0.308|1.481|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Rb Negative||1.481|0.308|0.3237
70982777|NCT04322708|141474169|SUPERIORITY||Percent Difference from Placebo|4.9||||0.5554|TWO_SIDED|95.0|-9.9|19.6|||Fisher Exact|||||19.6|-9.9|0.5554
70982778|NCT04322708|141474170|SUPERIORITY||LSM Difference from Placebo|-0.6||||0.9506|TWO_SIDED|95.0|-18.1|17.0|||ANCOVA|||||17.0|-18.1|0.9506
70982779|NCT04322708|141474170|SUPERIORITY||LSM Difference from Placebo|-17.6||||0.0511|TWO_SIDED|95.0|-35.4|0.1|||ANCOVA|||||0.1|-35.4|0.0511
70982780|NCT04322708|141474171|SUPERIORITY||LSM Difference from Placebo|2.6||||0.2007|TWO_SIDED|95.0|-1.4|6.7|||Mixed Models Analysis|||Weeks 23-24 Change from Baseline||6.7|-1.4|0.2007
70982781|NCT04322708|141474171|SUPERIORITY||LSM Difference from Placebo|-2.7||||0.1889|TWO_SIDED|95.0|-6.8|1.3|||Mixed Models Analysis|||Weeks 23-24 Change from Baseline||1.3|-6.8|0.1889
70982782|NCT04322708|141474172|SUPERIORITY||LSM Difference from Placebo|-0.3||||0.498|TWO_SIDED|95.0|-1.3|0.6|||ANCOVA|||||0.6|-1.3|0.4980
70982783|NCT04322708|141474172|SUPERIORITY||LSM Difference from Placebo|0.2||||0.639|TWO_SIDED|95.0|-0.7|1.2|||ANCOVA|||||1.2|-0.7|0.6390
70982784|NCT03959189|141474216|SUPERIORITY||mixed effects model|-0.0796|STANDARD_ERROR_OF_MEAN|0.2768||0.7746|TWO_SIDED|95.0|-0.6|0.5|||Mixed Models Analysis|||A mixed effects model will be used to compare SSS effects following ERX-963 versus placebo. In the primary analysis of SSS, the cohort 1 and cohort 2 data were combined for ERX-963 and placebo treatments.||0.5|-0.6|0.7746
70982785|NCT03959189|141474216|SUPERIORITY||mixed effects model|-0.2608|STANDARD_ERROR_OF_MEAN|0.3589||0.47|TWO_SIDED|95.0|-1.0|0.5|||Mixed Models Analysis|||A mixed effects model will be used to compare SSS effects following 1 mg ERX-963 versus placebo. In this analysis of SSS, the effect of 1 mg ERX-963 treatment was compared to the effect of placebo treatment.||0.5|-1.0|0.4700
70982786|NCT03959189|141474216|SUPERIORITY||mixed effects model|0.1016|STANDARD_ERROR_OF_MEAN|0.4272||0.8127|TWO_SIDED|95.0|-0.8|1.0|||Mixed Models Analysis|||A mixed effects model will be used to compare SSS effects following 2 mg ERX-963 versus placebo. In this analysis of SSS, the effect of 2 mg ERX-963 treatment was compared to the effect of placebo treatment.||1.0|-0.8|0.8127
70982787|NCT01476787|141474253|SUPERIORITY|||||||0.128|||||||Cochran-Mantel-Haenszel|||||||0.128
70982788|NCT01476787|141474254|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.406|TWO_SIDED|95.0|0.756|1.12|||Log Rank|||||1.120|0.756|0.406
70982789|NCT01476787|141474256|SUPERIORITY||Hazard Ratio (HR)|1.038|||||TWO_SIDED|95.0|0.854|1.261||||||||1.261|0.854|
70982790|NCT01476787|141474257|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.775|1.395||||||||1.395|0.775|
70982791|NCT01476787|141474258|SUPERIORITY||Hazard Ratio (HR)|0.809|||||TWO_SIDED|95.0|0.651|1.006|||Regression, Cox|||||1.006|0.651|
70982792|NCT01450137|141474271|SUPERIORITY||Risk Difference (RD)|0.45||||0.0301|TWO_SIDED|95.0|0.11|0.79|||Fisher Exact|||||0.79|0.11|0.0301
70982793|NCT01450137|141474272|SUPERIORITY||Risk Difference (RD)|0.65||||0.001|TWO_SIDED|95.0|0.36|0.94|||Fisher Exact|||||0.94|0.36|0.0010
70982794|NCT01450137|141474273|SUPERIORITY|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||||||0.0005
70982795|NCT01450137|141474274|SUPERIORITY||Mean Difference (Final Values)|25.0||||0.0005|TWO_SIDED|95.0|11.0|39.0|||z-test||Difference between restricted mean survival time at 12 months|||39|11|0.0005
70982796|NCT01477450|141474296|SUPERIORITY_OR_OTHER|||||||0.3|||||||Chi-squared|||||||0.3
70982797|NCT01477450|141474296|SUPERIORITY_OR_OTHER|||||||0.47|||||||Chi-squared|||||||0.47
70982798|NCT01477450|141474296|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.00
70982799|NCT03875235|141474297|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.021|TWO_SIDED|97.0|0.64|0.99||The analysis was performed using a stratified log-rank test adjusting for disease status (initially unresectable versus recurrent) and primary tumor location (IHCC versus EHCC versus GBC), and tested at 0.03 significance level.|Log Rank||The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for disease status and primary tumor location.|The 2-sided significance level for OS at the second interim analysis was 3%.|95% CI 0.66 to 0.97|0.99|0.64|0.021
70982800|NCT03875235|141474300|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.001|TWO_SIDED|95.19|0.63|0.89||The p-value is based on a stratified log-rank test adjusting for disease status (initially unresectable versus recurrent) and primary tumor location (IHCC versus EHCC versus GBC), and tested at 0.0481 significance level.|Log Rank||The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for disease status and primary tumor location.|The 2-sided significance level for PFS at the second interim analysis was 4.81%.|95% CI 0.63 to 0.89|0.89|0.63|0.001
70982801|NCT03875235|141474303|SUPERIORITY||Odds Ratio (OR)|1.6||||0.011|TWO_SIDED|95.0|1.11|2.31|||Cochran-Mantel-Haenszel||OR and CI were estimated from a stratified CMH test adjusting for disease status and primary tumor location.|||2.31|1.11|0.011
71036672|NCT03480763|141581602|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.37|||||TWO_SIDED|95.0|1.06|1.76||||||Serotype 23F (Shared)||1.76|1.06|
71036673|NCT03480763|141581602|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|12.79|||||TWO_SIDED|95.0|9.44|17.34||||||Serotype 22F (Unique to V114)||17.34|9.44|
71036674|NCT03480763|141581602|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|3.24|||||TWO_SIDED|95.0|2.73|3.84||||||Serotype 33F (Unique to V114)||3.84|2.73|
71036675|NCT03480763|141581603|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.78|||||TWO_SIDED|95.0|0.65|0.92||||||Serotype 1 (Shared)||0.92|0.65|
71036676|NCT03480763|141581603|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.42|||||TWO_SIDED|95.0|1.24|1.63||||||Serotype 3 (Shared)||1.63|1.24|
71036677|NCT03480763|141581603|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.77|||||TWO_SIDED|95.0|0.64|0.91||||||Serotype 4 (Shared)||0.91|0.64|
71036678|NCT03480763|141581603|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.89|||||TWO_SIDED|95.0|0.75|1.05||||||Serotype 5 (Shared)||1.05|0.75|
71036679|NCT03480763|141581603|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.37|||||TWO_SIDED|95.0|1.12|1.67||||||Serotype 6A (Shared)||1.67|1.12|
70982802|NCT03851510|141474313|OTHER|95% confidence of prevalence measure.|prevalence|46.3|||||TWO_SIDED|95.0|32.6|60.4||||||All participants that were consented, eligible, and completed the Vector EFL screening (supine).||60.4|32.6|
70982803|NCT01151137|141474318|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.294||||0.0019|TWO_SIDED|95.0|1.337|3.936||A priori threshold for statistical significance: 0.05|Log Rank|2-sided Log-rank's asymptotic test|"Hazard ratio (HR) of Dronedarone versus placebo for stroke, systemic arterial embolism, myocardial infarction or cardiovascular death~HR and confidence interval were estimated using Cox regression model with treatment group as the only factor."|As a consequence of the early termination of the study, the analysis was performed for information only without any adjustment.||3.936|1.337|0.0019
71008789|NCT02055976|141525255|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.11359|STANDARD_ERROR_OF_MEAN|0.16038|<|0.001|TWO_SIDED|95.0|-2.4323|-1.79489|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.79489|-2.43230|<0.001
71097288|NCT01740427|141703626|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.555|||<|0.0001|TWO_SIDED|95.0|0.437|0.705|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Cyclin D1 Positive||0.705|0.437|<0.0001
71097289|NCT01740427|141703626|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.997||||0.9964|TWO_SIDED|95.0|0.287|3.461|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Cyclin D1 Negative||3.461|0.287|0.9964
71097290|NCT01740427|141703626|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.518|||<|0.0001|TWO_SIDED|95.0|0.4|0.67|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for p16 Positive||0.670|0.400|<0.0001
71097291|NCT01740427|141703626|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.731||||0.3221|TWO_SIDED|95.0|0.392|1.364|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for p16 Negative||1.364|0.392|0.3221
71097292|NCT01740427|141703626|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.581|||<|0.0001|TWO_SIDED|95.0|0.455|0.742|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for p16 HScore\<175||0.742|0.455|<0.0001
71097293|NCT01740427|141703626|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.255||||0.0022|TWO_SIDED|95.0|0.1|0.65|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for p16 HScore\>=175||0.650|0.100|0.0022
71097294|NCT01740427|141703626|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.53||||0.0002|TWO_SIDED|95.0|0.379|0.742|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Ki67 \<=20%||0.742|0.379|0.0002
71097295|NCT01740427|141703626|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.569||||0.0007|TWO_SIDED|95.0|0.409|0.791|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Ki67 \>20%||0.791|0.409|0.0007
71097296|NCT01740427|141703630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.023||||0.0925|TWO_SIDED|95.0|-0.004|0.051|||Mixed Models Analysis|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||||0.051|-0.004|0.0925
71097297|NCT01740427|141703631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.325||||0.7822|TWO_SIDED|95.0|-2.63|1.98|||Mixed Models Analysis|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||||1.98|-2.63|0.7822
71097298|NCT01740427|141703633|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.956||||0.33775|TWO_SIDED|95.0|0.777|1.177||1-sided p-value from the stratified log-rank test.|Stratified Log Rank|||||1.177|0.777|0.337750
71097299|NCT01740427|141703634|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.921||||0.208706|TWO_SIDED|95.0|0.755|1.124||1-sided p-value from the stratified log-rank test.|Stratified Log Rank|||||1.124|0.755|0.208706
71097300|NCT04906421|141703637|SUPERIORITY|||||||0.0018||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|One-sided||ITT Population analysis||||0.0018
71097301|NCT04906421|141703637|SUPERIORITY|||||||0.0035||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||ITT Population Analysis||||0.0035
71097302|NCT04906421|141703637|SUPERIORITY|||||||0.0001||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|t-test, 1 sided|One-sided||mITT Population Analysis||||0.0001
71097303|NCT04906421|141703637|SUPERIORITY|||||||0.0003||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||mITT Population Analysis||||0.0003
71097304|NCT04906421|141703638|SUPERIORITY|||||||0.0087||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|One-sided||ITT Population Analysis||||0.0087
71097305|NCT04906421|141703638|SUPERIORITY|||||||0.0173||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||ITT Population Analysis||||0.0173
71097306|NCT04906421|141703638|SUPERIORITY|||||||0.0022||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|One-sided||mITT Population Analysis||||0.0022
71097307|NCT04906421|141703638|SUPERIORITY|||||||0.0044||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||mITT Population Analysis||||0.0044
71097308|NCT04906421|141703639|SUPERIORITY|||||||0.0102|TWO_SIDED|95.0||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||mITT Population Analysis||||0.0102
71036680|NCT03480763|141581603|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.48|||||TWO_SIDED|95.0|1.21|1.81||||||Serotype 6B (Shared)||1.81|1.21|
70982804|NCT01151137|141474319|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.947|||<|0.0001|TWO_SIDED|95.0|1.448|2.617||A priori threshold for statistical significance: 0.05|Log Rank|2-sided Log-rank's asymptotic test|"Hazard ratio (HR) of Dronedarone versus placebo for unscheduled cardiovascular hospitalization or death from any cause~HR and confidence interval were estimated using Cox regression model with treatment group as the only factor."|As a consequence of the early termination of the study, the analysis was performed for information only without any adjustment.||2.617|1.448|<0.0001
71036681|NCT03480763|141581603|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.86|||||TWO_SIDED|95.0|0.72|1.02||||||Serotype 7F (Shared)||1.02|0.72|
71036682|NCT03480763|141581603|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.04|||||TWO_SIDED|95.0|0.88|1.23||||||Serotype 9V (Shared)||1.23|0.88|
70982805|NCT01151137|141474321|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.115||||0.046|TWO_SIDED|95.0|0.996|4.49||A priori threshold for statistical significance: 0.05|Log Rank|2-sided Log-rank's asymptotic test|"Hazard ratio (HR) of Dronedarone versus placebo for cardiovascular death~HR and confidence interval were estimated using Cox regression model with treatment group as the only factor."|As a consequence of the early termination of the study, the analysis was performed for information only without any adjustment.||4.490|0.996|0.0460
70982806|NCT03478683|141474324|NON_INFERIORITY|Non-inferiority was to be demonstrated, if the lower bound of the two-sided 95 percentage (%) confidence interval around the (FF/UMEC/VI versus BUD/FOR+TIO) treatment difference was above -50 milliliter.|Mean Difference (Net)|0.015|STANDARD_ERROR_OF_MEAN|0.0143|||TWO_SIDED|95.0|-0.013|0.043|||||The primary treatment effect estimated (hypothetical effect) excluded data following intercurrent events: discontinuation of treatment, taking wrong treatment, taking prohibited medication, unblinding, noncompliance, COPD exacerbation or pneumonia.|||0.043|-0.013|
70982807|NCT03478683|141474325|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.0139||0.481|TWO_SIDED|95.0|-0.037|0.018||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 2 using p-values.|Mixed model repeated measures||Day 2|||0.018|-0.037|0.481
70982808|NCT03478683|141474325|SUPERIORITY||Mean Difference (Net)|0.061|STANDARD_ERROR_OF_MEAN|0.0124|<|0.001|TWO_SIDED|95.0|0.037|0.086||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 28 using p-values.|Mixed model repeated measures||Day 28|||0.086|0.037|<0.001
70982809|NCT03478683|141474325|SUPERIORITY||Mean Difference (Net)|0.058|STANDARD_ERROR_OF_MEAN|0.0133|<|0.001|TWO_SIDED|95.0|0.032|0.084||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 84 using p-values.|Mixed model repeated measures||Day 84|||0.084|0.032|<0.001
70982810|NCT03478683|141474325|SUPERIORITY||Mean Difference (Net)|0.038|STANDARD_ERROR_OF_MEAN|0.014||0.007|TWO_SIDED|95.0|0.01|0.066||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 85 using p-values.|Mixed model repeated measures||Day 85|||0.066|0.010|0.007
70982811|NCT03478683|141474326|SUPERIORITY||Mean Difference (Net)|-0.009|STANDARD_ERROR_OF_MEAN|0.011||0.415|TWO_SIDED|95.0|-0.03|0.013||Only if superiority is achieved on the primary study endpoint, then inferences can be made on weighted mean change from Baseline in FEV1 over 0-24 hours on Day 1 using p-values.|Mixed model repeated measures||The treatment effect to be estimated was hypothetical effect if all participants stayed on their randomized study treatment. Only on treatment data was included in analysis.|||0.013|-0.030|0.415
70982812|NCT03478683|141474327|SUPERIORITY||Mean Difference (Net)|0.013|STANDARD_ERROR_OF_MEAN|0.0138||0.335|TWO_SIDED|95.0|-0.014|0.04||The analysis was performed using mixed model repeated measures analysis, which included covariates of Baseline FEV1, geographical region, treatment, visit, visit by treatment and visit by Baseline interaction.|Mixed model repeated measures||The treatment effect to be estimated was hypothetical effect if all participants stayed on their randomized study treatment. Only on treatment data was included in analysis.|||0.040|-0.014|0.335
71036683|NCT03480763|141581603|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.05|||||TWO_SIDED|95.0|0.88|1.26||||||Serotype 14 (Shared)||1.26|0.88|
71036684|NCT03480763|141581603|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.38|||||TWO_SIDED|95.0|1.17|1.64||||||Serotype 18C (Shared)||1.64|1.17|
71036685|NCT03480763|141581603|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.13|||||TWO_SIDED|95.0|0.97|1.33||||||Serotype 19A (Shared)||1.33|0.97|
71036686|NCT03480763|141581603|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.13|||||TWO_SIDED|95.0|0.96|1.32||||||Serotype 19F (Shared)||1.32|0.96|
71036687|NCT03480763|141581603|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.35|||||TWO_SIDED|95.0|1.12|1.62||||||Serotype 23F (Shared)||1.62|1.12|
71036688|NCT03480763|141581603|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|6.2|||||TWO_SIDED|95.0|5.33|7.21||||||Serotype 22F (Unique to V114)||7.21|5.33|
71036689|NCT03480763|141581603|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|5.01|||||TWO_SIDED|95.0|4.38|5.73||||||Serotype 33F (Unique to V114)||5.73|4.38|
71036690|NCT05143801|141581621|EQUIVALENCE|Main effect for environmental conditions.||||||0.003||||||Statistical significance was set at p \< 0.05.|2x2 repeated measures ANOVA|||||||0.003
71036691|NCT05143801|141581621|EQUIVALENCE|Main effect for mask condition.||||||0.933||||||Statistical significance was set at p \< 0.05.|2x2 repeated measures ANOVA|||||||0.933
71036692|NCT05143801|141581621|EQUIVALENCE|Interaction effect across environmental and mask conditions.|No Method of Estimation was used|||||0.344||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 repeated measures ANOVA|||||||0.344
71036693|NCT05143801|141581622|EQUIVALENCE|Main effect for environmental conditions.||||||0.117||||||Statistical significance was set at p \< 0.05.|2x2 Repeated Measures ANOVA|||A 2x2 repeated measures ANOVA was performed to investigate statistical differences for all variables across the four conditions. Both main and interaction effects were calculated along with effect size, reported as partial ⴄ2 as provided by the statistical software JASP (version 0.14.1.0).||||0.117
70982813|NCT00770861|141474332|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|Between-treatment comparison of efficacy was performed by ANCOVA, with treatment, baseline BMI, center as factors \& baseline value as a covariate.||H0 - There was no difference in BP reduction between Neb and Placebo. The efficacy analyses were based on the ITT population for the double-blind treatment phase. The LOCF was used to impute missing postbaseline values. Sensitivity analyses were based on observed cases for all efficacy parameters. All statistical tests were two-sided hypothesis tests performed at the 5% level of significance for main effects. All confidence intervals were two-sided 95% confidence intervals.||||<0.0001
70982814|NCT00770861|141474333|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||||||0.001
70982815|NCT01287117|141474336|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.96||||0.001|TWO_SIDED|95.0|-4.71|-1.21||A multiplicity type I error control plan was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided).|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups.||-1.21|-4.71|0.0010
70982816|NCT01287117|141474336|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.95||||0.0012|TWO_SIDED|95.0|-4.72|-1.18||A multiplicity type I error control plan was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided).|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||-1.18|-4.72|0.0012
70982817|NCT01287117|141474336|SUPERIORITY_OR_OTHER||Least squares mean difference|-5.8|||<|0.0001|TWO_SIDED|95.0|-7.49|-4.1||A multiplicity type I error control plan was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided).|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-4.10|-7.49|<0.0001
70982818|NCT01287117|141474337|SUPERIORITY_OR_OTHER||Least squares mean difference|-5.75||||0.0035|TWO_SIDED|95.0|-9.59|-1.92||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups.||-1.92|-9.59|0.0035
70982819|NCT01287117|141474337|SUPERIORITY_OR_OTHER||Least squares mean difference|-6.54||||0.0008|TWO_SIDED|95.0|-10.33|-2.75||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||-2.75|-10.33|0.0008
70982820|NCT01287117|141474337|SUPERIORITY_OR_OTHER||Least squares mean difference|-12.8|||<|0.0001|TWO_SIDED|95.0|-16.44|-9.16||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-9.16|-16.44|<0.0001
70982821|NCT01287117|141474338|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.75||||0.0149|TWO_SIDED|95.0|-4.95|-0.54||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups.||-0.54|-4.95|0.0149
71036694|NCT05143801|141581622|EQUIVALENCE|Main effect for mask condition||||||0.832||||||Statistical significance was set at p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.832
71036695|NCT05143801|141581622|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.879||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.879
71036696|NCT05143801|141581623|EQUIVALENCE|Main effect for environmental condition.||||||0.749||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.749
71097309|NCT04906421|141703639|SUPERIORITY|||||||0.59|TWO_SIDED|95.0||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||Subgroup Fibrosis Stage F2 at Baseline Population Analysis||||0.59
71036697|NCT05143801|141581623|EQUIVALENCE|Main effect for mask condition.||||||0.311||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.311
71097310|NCT04906421|141703639|SUPERIORITY|||||||0.0032|TWO_SIDED|95.0||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-Sided||Subgroup Fibrosis Stage F3 at Baseline Population Analysis||||0.0032
70982822|NCT01287117|141474338|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.44||||0.0017|TWO_SIDED|95.0|-5.57|-1.32||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||-1.32|-5.57|0.0017
71036698|NCT05143801|141581623|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.368||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.368
71036699|NCT05143801|141581624|EQUIVALENCE|Main effect for environmental condition.||||||0.789||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.789
71036700|NCT05143801|141581624|EQUIVALENCE|Main effect for mask condition.||||||0.739||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.739
71036701|NCT05143801|141581624|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.158||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.158
71036702|NCT05143801|141581625|EQUIVALENCE|Main effect for environmental condition.||||||0.394||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.394
71036703|NCT05143801|141581625|EQUIVALENCE|Main effect for mask condition||||||0.157||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.157
71036704|NCT05143801|141581625|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.015||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.015
71097311|NCT04906421|141703639|SUPERIORITY|||||||0.0764|TWO_SIDED|95.0||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||Subgroup Type 2 Diabetes Mellitus at Baseline Population Analysis||||0.0764
70982823|NCT01287117|141474338|SUPERIORITY_OR_OTHER||Least squares mean difference|-6.93|||<|0.0001|TWO_SIDED|95.0|-9.1|-4.76||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-4.76|-9.10|<0.0001
70982824|NCT01287117|141474339|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.39||||0.0879|TWO_SIDED|95.0|0.95|2.03||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups.||2.03|0.95|0.0879
70982825|NCT01287117|141474339|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49||||0.0301|TWO_SIDED|95.0|1.04|2.14||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||2.14|1.04|0.0301
71036705|NCT05143801|141581626|EQUIVALENCE|Main effect for environmental condition.||||||0.96||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.960
71036706|NCT05143801|141581626|EQUIVALENCE|Main effect for mask condition.||||||0.073||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.073
71036707|NCT05143801|141581626|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.503||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.503
71036708|NCT05143801|141581627|EQUIVALENCE|Main effect for environmental condition.||||||0.786||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.786
71036709|NCT05143801|141581627|EQUIVALENCE|Main effect for mask condition.||||||0.18||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.180
71036710|NCT05143801|141581627|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.239||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.239
71036711|NCT05143801|141581628|EQUIVALENCE|Main effect for environmental condition.||||||0.134||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.134
71036712|NCT05143801|141581628|EQUIVALENCE|Main effect for mask condition.||||||0.621||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.621
71036713|NCT05143801|141581628|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.553||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.553
71036714|NCT05143801|141581629|EQUIVALENCE|Main effect for environmental condition.||||||0.461||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.461
71097312|NCT04906421|141703640|SUPERIORITY|||||||0.0043||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||mITT Population Analysis||||0.0043
70982826|NCT01287117|141474339|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.34|||<|0.0001|TWO_SIDED|95.0|1.63|3.36||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||3.36|1.63|<0.0001
70982827|NCT01287117|141474340|SUPERIORITY_OR_OTHER|||||||0.0148||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||||0.0148
70982828|NCT01287117|141474340|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||||<0.0001
71036715|NCT05143801|141581629|EQUIVALENCE|Main effect for mask condition.||||||0.877||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.877
70982829|NCT01287117|141474340|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
71036716|NCT05143801|141581629|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.919||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.919
71097313|NCT04906421|141703641|SUPERIORITY|||||||0.0018||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||mITT Population Analysis||||0.0018
71036717|NCT05143801|141581630|EQUIVALENCE|Main effect for environmental condition.||||||0.466||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.466
71036718|NCT05143801|141581630|EQUIVALENCE|Main effect for mask condition.||||||0.186||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.186
71097314|NCT04906421|141703642|SUPERIORITY||||||<|0.0001||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||mITT Population Analysis||||<0.0001
71036719|NCT05143801|141581630|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.08||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.080
71036720|NCT05143801|141581631|EQUIVALENCE|Main effect for environmental condition.||||||0.375||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.375
71036721|NCT05143801|141581631|EQUIVALENCE|Main effect for mask condition.||||||0.178||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.178
71036722|NCT05143801|141581631|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.533||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.533
71036723|NCT05143801|141581632|EQUIVALENCE|Main effect for environmental condition.||||||0.29||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.290
71036724|NCT05143801|141581632|EQUIVALENCE|Main effect for mask condition.||||||0.527||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.527
71097315|NCT05067270|141703655|OTHER||Geometric Least Squares Mean Ratio|1.77|||||TWO_SIDED|95.0|1.3|2.4||||||1 min post bolus (Bolus time: 3 hours)||2.40|1.30|
71097316|NCT05067270|141703655|OTHER||Geometric Least Squares Mean Ratio|1.91|||||TWO_SIDED|95.0|1.42|2.59||||||1 min post bolus (Bolus time: 3 hours)||2.59|1.42|
71097317|NCT05067270|141703655|OTHER||Geometric Least Squares Mean Ratio|1.84|||||TWO_SIDED|95.0|1.37|2.49||||||1 min post bolus (Bolus time: 3 hours)||2.49|1.37|
71097318|NCT05067270|141703655|OTHER||Geometric Least Squares Mean Ratio|1.42|||||TWO_SIDED|95.0|1.05|1.92||||||1 min post bolus (Bolus time: 3 hours)||1.92|1.05|
71097319|NCT05067270|141703655|OTHER||Geometric Least Squares Mean Ratio|1.08|||||TWO_SIDED|95.0|0.8|1.46||||||1 min post bolus (Bolus time: 3 hours)||1.46|0.80|
70982830|NCT01287117|141474341|SUPERIORITY_OR_OTHER|||||||0.0118||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||||0.0118
70982831|NCT01287117|141474341|SUPERIORITY_OR_OTHER|||||||0.0226||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||||0.0226
70982832|NCT01287117|141474341|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
70982833|NCT01287117|141474342|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.34||||0.0124|TWO_SIDED|95.0|-4.17|-0.51||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||-0.51|-4.17|0.0124
70982834|NCT01287117|141474342|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.16||||0.0012|TWO_SIDED|95.0|-5.05|-1.27||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||-1.27|-5.05|0.0012
70982835|NCT01287117|141474342|SUPERIORITY_OR_OTHER||Least squares mean difference|-5.73|||<|0.0001|TWO_SIDED|95.0|-7.59|-3.87||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-3.87|-7.59|<0.0001
70982836|NCT01287117|141474343|SUPERIORITY_OR_OTHER||Least squares mean difference|0.26||||0.7956|TWO_SIDED|95.0|-1.76|2.28||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||2.28|-1.76|0.7956
70982837|NCT01287117|141474343|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.31||||0.2286|TWO_SIDED|95.0|-3.46|0.84||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||0.84|-3.46|0.2286
70982838|NCT01287117|141474343|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.08|||<|0.0001|TWO_SIDED|95.0|-5.96|-2.2||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-2.20|-5.96|<0.0001
70982839|NCT01287117|141474344|SUPERIORITY_OR_OTHER|||||||0.4867||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||||0.4867
70982840|NCT01287117|141474344|SUPERIORITY_OR_OTHER|||||||0.1747||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||||0.1747
70982841|NCT01287117|141474344|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
70982842|NCT01287117|141474345|SUPERIORITY_OR_OTHER|||||||0.458||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||||0.4580
70982843|NCT01287117|141474345|SUPERIORITY_OR_OTHER|||||||0.2087||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||||0.2087
71097320|NCT05067270|141703655|OTHER||Geometric Least Squares Mean Ratio|1.04|||||TWO_SIDED|95.0|0.77|1.41||||||1 min post bolus (Bolus time: 3 hours)||1.41|0.77|
71097321|NCT05067270|141703655|OTHER||Geometric Least Squares Mean Ratio|0.8|||||TWO_SIDED|95.0|0.59|1.08||||||1 min post bolus (Bolus time: 3 hours)||1.08|0.59|
71097322|NCT05067270|141703655|OTHER||Geometric Least Squares Mean Ratio|0.96|||||TWO_SIDED|95.0|0.72|1.3||||||1 min post bolus (Bolus time: 3 hours)||1.30|0.72|
71097323|NCT05067270|141703655|OTHER||Geometric Least Squares Mean Ratio|0.74|||||TWO_SIDED|95.0|0.55|1.0||||||1 min post bolus (Bolus time: 3 hours)||1.00|0.55|
71097324|NCT05067270|141703655|OTHER||Geometric Least Squares Mean Ratio|0.77|||||TWO_SIDED|95.0|0.57|1.04||||||1 min post bolus (Bolus time: 3 hours)||1.04|0.57|
71097325|NCT05067270|141703655|OTHER||Geometric Least Squares Mean Ratio|1.49|||||TWO_SIDED|95.0|1.09|2.02||||||1 min post bolus (Bolus time: 6 hours)||2.02|1.09|
71097326|NCT05067270|141703655|OTHER||Geometric Least Squares Mean Ratio|1.68|||||TWO_SIDED|95.0|1.25|2.28||||||1 min post bolus (Bolus time: 6 hours)||2.28|1.25|
70982844|NCT01287117|141474345|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
70982845|NCT00630032|141474346|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.175|TWO_SIDED|95.0|0.59|1.1|||Log Rank|||||1.10|0.59|0.175
71097327|NCT05067270|141703655|OTHER||Geometric Least Squares Mean Ratio|1.84|||||TWO_SIDED|95.0|1.36|2.48||||||1 min post bolus (Bolus time: 6 hours)||2.48|1.36|
71097328|NCT05067270|141703655|OTHER||Geometric Least Squares Mean Ratio|1.16|||||TWO_SIDED|95.0|0.85|1.56||||||1 min post bolus (Bolus time: 6 hours)||1.56|0.85|
71097329|NCT05067270|141703655|OTHER||Geometric Least Squares Mean Ratio|1.13|||||TWO_SIDED|95.0|0.83|1.54||||||1 min post bolus (Bolus time: 6 hours)||1.54|0.83|
71097330|NCT05067270|141703655|OTHER||Geometric Least Squares Mean Ratio|1.24|||||TWO_SIDED|95.0|0.91|1.68||||||1 min post bolus (Bolus time: 6 hours)||1.68|0.91|
71097331|NCT05067270|141703655|OTHER||Geometric Least Squares Mean Ratio|0.78|||||TWO_SIDED|95.0|0.57|1.05||||||1 min post bolus (Bolus time: 6 hours)||1.05|0.57|
71097332|NCT05067270|141703655|OTHER||Geometric Least Squares Mean Ratio|1.09|||||TWO_SIDED|95.0|0.81|1.47||||||1 min post bolus (Bolus time: 6 hours)||1.47|0.81|
71097333|NCT05067270|141703655|OTHER||Geometric Least Squares Mean Ratio|0.69|||||TWO_SIDED|95.0|0.51|0.93||||||1 min post bolus (Bolus time: 6 hours)||0.93|0.51|
71097334|NCT05067270|141703655|OTHER||Geometric Least Squares Mean Ratio|0.63|||||TWO_SIDED|95.0|0.47|0.85||||||1 min post bolus (Bolus time: 6 hours)||0.85|0.47|
71097335|NCT05067270|141703655|OTHER||Geometric Least Squares Mean Ratio|1.49|||||TWO_SIDED|95.0|1.1|2.03||||||1 min post bolus (Bolus time: 9 hours)||2.03|1.10|
71097336|NCT05067270|141703655|OTHER||Geometric Least Squares Mean Ratio|1.96|||||TWO_SIDED|95.0|1.45|2.65||||||1 min post bolus (Bolus time: 9 hours)||2.65|1.45|
71097337|NCT05067270|141703655|OTHER||Geometric Least Squares Mean Ratio|2.03|||||TWO_SIDED|95.0|1.5|2.74||||||1 min post bolus (Bolus time: 9 hours)||2.74|1.50|
71097338|NCT05067270|141703655|OTHER||Geometric Least Squares Mean Ratio|1.25|||||TWO_SIDED|95.0|0.93|1.69||||||1 min post bolus (Bolus time: 9 hours)||1.69|0.93|
71097339|NCT05067270|141703655|OTHER||Geometric Least Squares Mean Ratio|1.31|||||TWO_SIDED|95.0|0.97|1.78||||||1 min post bolus (Bolus time: 9 hours)||1.78|0.97|
71097340|NCT05067270|141703655|OTHER||Geometric Least Squares Mean Ratio|1.36|||||TWO_SIDED|95.0|1.01|1.84||||||1 min post bolus (Bolus time: 9 hours)||1.84|1.01|
71097341|NCT05067270|141703655|OTHER||Geometric Least Squares Mean Ratio|0.84|||||TWO_SIDED|95.0|0.62|1.14||||||1 min post bolus (Bolus time: 9 hours)||1.14|0.62|
71097342|NCT05067270|141703655|OTHER||Geometric Least Squares Mean Ratio|1.04|||||TWO_SIDED|95.0|0.77|1.4||||||1 min post bolus (Bolus time: 9 hours)||1.40|0.77|
71097343|NCT05067270|141703655|OTHER||Geometric Least Squares Mean Ratio|0.64|||||TWO_SIDED|95.0|0.47|0.86||||||1 min post bolus (Bolus time: 9 hours)||0.86|0.47|
71097344|NCT05067270|141703655|OTHER||Geometric Least Squares Mean Ratio|0.62|||||TWO_SIDED|95.0|0.46|0.83||||||1 min post bolus (Bolus time: 9 hours)||0.83|0.46|
71097345|NCT02186171|141703664|SUPERIORITY||LS Mean Difference|10.9|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|9.6|12.2||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA|||||12.2|9.6|< 0.0001
70982846|NCT00630032|141474347|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.1687|TWO_SIDED|95.0|0.53|1.11|||Log Rank|||||1.11|0.53|0.1687
70982847|NCT00630032|141474348|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.6502|TWO_SIDED|95.0|0.45|1.63|||Log Rank|||||1.63|0.45|0.6502
70982848|NCT00630032|141474349|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0665|TWO_SIDED|95.0|0.49|1.02|||Log Rank|||||1.02|0.49|0.0665
70982849|NCT00630032|141474350|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.148|TWO_SIDED|95.0|0.59|1.08|||Log Rank|||||1.08|0.59|0.148
70982850|NCT00630032|141474351|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8968|TWO_SIDED|95.0|0.67|1.42|||Log Rank|||||1.42|0.67|0.8968
70982851|NCT02332915|141474352|SUPERIORITY|||||||0.0128|||||||t-test, 2 sided|dependent t-test||Null hypothesis is that there is no difference in mean effect size values for 2-week follow-up values for treated items for SPT-Intense and SPT-Traditional. The test was performed with a significance level of 0.05 (two-sided).||||.0128
71036725|NCT05143801|141581632|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.045||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.045
71036726|NCT05143801|141581633|EQUIVALENCE|Main effect for environmental condition.||||||0.018||||||Statistical significance was set at p \< 0.05|2x2x3 Repeated Measures ANOVA|||||||0.018
71036727|NCT05143801|141581633|EQUIVALENCE|Main effect for mask condition.|||||<|0.001||||||Statistical significance was set at p \< 0.05|2x2x3 Repeated Measures ANOVA|||||||<0.001
71036728|NCT05143801|141581633|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.035||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2x3 Repeated Measures ANOVA|||||||0.035
71036729|NCT05143801|141581634|EQUIVALENCE|Main effect for environmental condition.|||||<|0.001||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||<0.001
71036730|NCT05143801|141581634|EQUIVALENCE|Main effect for mask condition.||||||0.678||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.678
71036731|NCT05143801|141581634|EQUIVALENCE|Interaction effect||||||0.678|||||||2x2 Repeated Measures ANOVA|||||||0.678
70982852|NCT02332915|141474353|SUPERIORITY|||||||0.942|||||||t-test, 2 sided|dependent t-test||Null hypothesis is that there is no difference in mean effect size values for 2-week follow-up values for untreated (generalization) items for SPT-Intense and SPT-Traditional. The test was performed with a significance level of 0.05 (two-sided).||||.942
70982853|NCT02332915|141474354|OTHER||||||<|0.001|||||||t-test, 2 sided|||Null Hypothesis: No difference in pre-treatment and post-treatment intelligibility scores||||<.001
70982854|NCT03063385|141474364|OTHER|\[Not specified\]|Slope|0.0153|STANDARD_ERROR_OF_MEAN|0.0067||0.0229|TWO_SIDED|95.0|0.0022|0.0285||Statistical significance taken at the 0.05 level|GEE modeling|P-value \& estimate rely on group x time interaction effect on primary outcome when controlling for self-efficacy. Used modified Baron \& Kenny method|\[Not specified\]|The intervention effect of sexual risk communication (primary outcome in parents) controlling for self-efficacy as a mediator from baseline through 12 months was examined using longitudinal general estimating equations (GEE) modeling, with the Health promotion control condition as the reference category and adjusting for baseline sexual risk communication and average monthly income.||0.0285|0.0022|.0229
70982855|NCT03063385|141474364|OTHER|\[Not specified\]|Slope|0.0151|STANDARD_ERROR_OF_MEAN|0.0067||0.0249|TWO_SIDED|95.0|0.0019|0.0282||Statistical significance taken at the 0.05 level|GEE modeling|P-value and estimate rely on group x time interaction effect on primary outcome when controlling for sexual communication attitudes. Same method B\&K|\[Not specified\]|The intervention effect of sexual risk communication (primary outcome in parents) controlling for sexual communication attitudes as a mediator from baseline through 12 months was examined using longitudinal general estimating equations (GEE) modeling, with the Health promotion control condition as the reference category and adjusting for baseline sexual risk communication and average monthly income.||0.0282|0.0019|0.0249
71036732|NCT05143801|141581635|EQUIVALENCE|Main effect for environmental condition.|||||<|0.001||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||<0.001
71036733|NCT05143801|141581635|EQUIVALENCE|Main effect for mask condition.||||||0.487||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.487
71036734|NCT05143801|141581635|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.79||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.790
71036735|NCT05143801|141581636|EQUIVALENCE|Main effect for environmental condition.||||||0.089||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.089
71036736|NCT05143801|141581636|EQUIVALENCE|Main effect for mask condition.||||||0.297||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.297
71036737|NCT05143801|141581636|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.111||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.111
71036738|NCT05143801|141581637|EQUIVALENCE|Main effect for environmental condition.||||||0.024||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.024
71036739|NCT05143801|141581637|EQUIVALENCE|Main effect for mask condition.||||||0.002||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.002
71036740|NCT05143801|141581637|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.014||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.014
71036741|NCT05143801|141581638|EQUIVALENCE|Main effect for environmental condition.||||||0.012||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.012
71036742|NCT05143801|141581638|EQUIVALENCE|Main effect for mask condition.||||||0.893||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.893
70982856|NCT03063385|141474364|OTHER|\[Not specified\]|Slope|0.0158|STANDARD_ERROR_OF_MEAN|0.0068||0.0204|TWO_SIDED|95.0|0.0025|0.0292||Statistical significance taken at the 0.05 level|GEE modeling|Reported P-value and estimate rely on the group x time interaction effect on primary outcome when controlling for subjective norms. Same method B\&K|\[Not specified\]|The intervention effect of sexual risk communication (primary outcome in parents) controlling for subjective norms as a mediator from baseline through 12 months was examined using longitudinal general estimating equations (GEE) modeling, with the Health promotion control condition as the reference category and adjusting for baseline sexual risk communication and average monthly income.||0.0292|0.0025|0.0204
70982857|NCT05165394|141474375|SUPERIORITY||Least-Squares Mean Treatment Difference|-3.9|STANDARD_ERROR_OF_MEAN|3.5||0.8663|ONE_SIDED|90.0|-8.4|||Significance level = 0.1|ANCOVA||Confidence interval and p-value are one-sided for test of null hypothesis that the LS mean difference between NBI-1065846 and placebo in DARS total score at Day 57 is greater than or equal to zero.||||-8.4|0.8663
70982858|NCT05165394|141474376|SUPERIORITY||Least-Squares Mean Treatment Difference|-1.1|STANDARD_ERROR_OF_MEAN|3.0||0.7008|TWO_SIDED|95.0|-7.1|4.8|||ANCOVA||NBI-1065846 - Placebo|||4.8|-7.1|0.7008
70982859|NCT05165394|141474377|SUPERIORITY|||||||0.9051|||||||Cochran-Mantel-Haenszel Chi-square test|||CGI-S scores at Day 57 for NBI-1065846 compared to placebo.||||0.9051
70982860|NCT00492622|141474378|EQUIVALENCE|Primary study objective was to compare the pharmacokinetics of omeprazole between IR and DR omeprazole in patients with GERD associated with gastroparesis.|||||<|0.01||||||\<0.01 is used for determining the level of significance.|paired t-tests|||||||< 0.01
70982861|NCT00492622|141474379|EQUIVALENCE|Primary study objective was to compare the pharmacokinetics of omeprazole between IR and DR omeprazole in patients with GERD associated with gastroparesis.|||||||||||||||||P\<0.05 was used as the level of significance with ANOVA for this endpoint.|||
70982862|NCT00492622|141474380|EQUIVALENCE|Primary study objective was to compare the pharmacokinetics of omeprazole between IR and DR omeprazole in patients with GERD associated with gastroparesis.||||||0.95||||||An analysis of variance model was used to compare AUC between IR and DR omeprazole using the natural logarithmic transformation. The model included the following factors: treatment, period, sequence and patient nested within the sequence.|ANOVA|||||||0.95
70982863|NCT01332435|141474381|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
70982864|NCT01332435|141474381|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Chi-squared|||||||0.0002
70982865|NCT01332435|141474382|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
70982866|NCT01332435|141474382|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||Chi-squared|||||||0.0006
70982867|NCT01332435|141474383|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
70982868|NCT01332435|141474383|SUPERIORITY_OR_OTHER|||||||0.0699||95.0|||||Chi-squared|||||||0.0699
70982869|NCT01332435|141474384|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|||||||<0.001
70982870|NCT01332435|141474384|SUPERIORITY_OR_OTHER|||||||0.8645||95.0|||||Regression, Linear|||||||0.8645
70982871|NCT01332435|141474385|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|||||||<0.001
70982872|NCT01332435|141474385|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|||||||<0.001
70982873|NCT02517515|141474387|SUPERIORITY|The superiority of the rate of sustained virologic response at 12 weeks after treatment (SVR12) for the treatment-naïve participants in the Double-blind 3-DAA group as compared with the historical rate for treatment-naïve patients treated with TVR + pegIFN + RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with SVR12 must exceed 84% to achieve superiority.|percentage of participants|99.5|||||TWO_SIDED|95.0|97.0|99.9||||||Based on a 2-sided significance level of 0.05 and an underlying rate of 96% for the Double-blind 3-DAA treatment-naïve group, the sample size 180 treatment-naïve participants provided \>90% power to demonstrate superiority of the regimen to the historical rate for treatment-naïve patients treated with TVR + pegIFN + RBV (80%) (based on one-sample chi-square test of a single binomial proportion for superiority).||99.9|97.0|
70982874|NCT02517515|141474387|SUPERIORITY|The superiority of the rate of sustained virologic response at 12 weeks after treatment for the treatment-experienced participants in the Double-blind 3-DAA group as compared with the historical rate for treatment-experienced patients treated with TVR + pegIFN + RBV was analyzed; the lower confidence bound of the 2-sided 95% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority.|percentage of participants|100.0|||||TWO_SIDED|95.0|97.4|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of 96% for the Double-blind 3-DAA treatment-experienced group, the sample size 180 treatment-experienced participants provided \>90% power to demonstrate superiority of the regimen to the historical rate for treatment-experienced patients treated with TVR + pegIFN + RBV (80%) (based on one-sample chi-square test of a single binomial proportion for superiority).||100.0|97.4|
70982875|NCT02517515|141474388|SUPERIORITY|The superiority of the rate of sustained virologic response at 24 weeks after treatment (SVR24) for the treatment-naïve participants in the Double-blind 3-DAA group as compared with the historical rate for treatment-naïve patients treated with TVR + pegIFN + RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with SVR24 must exceed 84% to achieve superiority.|percentage of participants|99.5|||||TWO_SIDED|95.0|97.0|99.9||||||Based on a 2-sided significance level of 0.05 and an underlying rate of 96% for the Double-blind 3-DAA treatment-experienced group, the sample size 180 treatment-experienced participants provided \>90% power to demonstrate superiority of the regimen to the historical rate for treatment-experienced patients treated with TVR + pegIFN + RBV (80%) (based on one-sample chi-square test of a single binomial proportion for superiority).||99.9|97.0|
70982876|NCT02517515|141474388|SUPERIORITY|The superiority of the rate of sustained virologic response at 24 weeks after treatment (SVR24) for the treatment-experienced participants in the double-blind 3-DAA group as compared with the historical rate for treatment-experienced patients treated with TVR + pegIFN + RBV was analyzed; the lower confidence bound of the 2-sided 95% CI for the percentage of participants with SVR24 must exceed 75% to achieve superiority.|percentage of participants|100.0|||||TWO_SIDED|95.0|97.4|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of 96% for the Double-blind 3-DAA treatment-experienced group, the sample size 180 treatment-experienced participants provided \>90% power to demonstrate superiority of the regimen to the historical rate for treatment-experienced patients treated with TVR + pegIFN + RBV (80%) (based on one-sample chi-square test of a single binomial proportion for superiority).||100.0|97.4|
70982877|NCT02786537|141474396|SUPERIORITY|Superiority test derived by comparing whether the 95% CI includes zero.|Mean Difference (Net)|-1.7|||||TWO_SIDED|95.0|-3.6|0.3|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|PROD vs. SOF/LDV based regimens as reported in PRO (ALL PATIENTS WHO STARTED TREATMENT BY ARM AS TREATED), population limited to as randomization date of the last PrOD patient start date - RBV FREE REGIMENS||0.3|-3.6|
70982878|NCT02786537|141474396|SUPERIORITY||Mean Difference (Net)|1.4|||||TWO_SIDED|95.0|-0.4|3.1|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method. CI for median derived from PROC QUANTREG.|RBV free EBR/GZR regimen compared to PrOD in consideration that RBV usage was determined by provider and not study randomization.||3.1|-0.4|
70982879|NCT02786537|141474397|SUPERIORITY|Superiority test completed by comparing whether the 95% CI includes zero.|Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-0.6|1.0|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|Analysis based on RBV free EBR/GZR regimen vs SOF/LDV (all patients who started treatment by arm as treated)||1.0|-0.6|
70982880|NCT02786537|141474399|SUPERIORITY|Superiority test comparison based on whether the 95% CI includes zero|Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|0.0|1.0|||||The comparisons between regimens can be viewed as superiority test, by comparing whether the 95% CI includes zero|Analysis of EBR/GZR vs. SOF/LDV irrespective of RBV usage in consideration that RBV usage was determined by provider and not study randomization.||1.0|0.0|
70982881|NCT02786537|141474400|SUPERIORITY|Superiority test comparison based on whether the 95% CI includes zero|Mean Difference (Net)|1.4|||||TWO_SIDED|95.0|-4.2|7.0|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method|Analysis based on RBV free SOF/LDV vs. PrOD in consideration that RBV usage was determined by provider and not study randomization and limited RBV sample size.||7.0|-4.2|
71036743|NCT05143801|141581638|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.969||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.969
71036744|NCT03629054|141581639|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (gMean) (T/R).|Adjusted gMean ratio|100.42|STANDARD_ERROR_OF_MEAN|4.8|<|0.0001|TWO_SIDED|90.0|98.17|102.72|||ANOVA||gMean ratio = T/R. Standard error of the mean is actually intra-individual geometric coefficient of variation (gCV).|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||102.72|98.17|<0.0001
71036745|NCT03629054|141581640|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|95.34|STANDARD_ERROR_OF_MEAN|8.5|<|0.0001|TWO_SIDED|90.0|91.58|99.24|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||99.24|91.58|<0.0001
70982882|NCT02786537|141474400|SUPERIORITY|Superiority test comparison based on whether the 95% CI includes zero.|Mean Difference (Net)|1.4|||||TWO_SIDED|95.0|-4.2|7.0|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|RBV free PrOD vs. SOF/LDV regimens (all patients who started treatment by arm as treated, population is limited to as randomization date of the last PrOD patient start date)||7.0|-4.2|
70982883|NCT02786537|141474401|SUPERIORITY|Superiority test comparison based on whether the 95% CI includes zero|Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-1.6|1.3|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|RBV free EBR/GZR vs. SOF/LDV (all patients who started treatment by arm as treated)||1.3|-1.6|
70982884|NCT02786537|141474404|SUPERIORITY|Superiority test based on whether the 95% CI includes zero|Mean Difference (Net)|1.8|||||TWO_SIDED|95.0|-1.9|5.5|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|RBV free EBR/GZR vs. PrOD regimens as reported in PRO (all patients who started treatment by arm as treated, population is limited to as randomization date of the last PrOD patient start date). Analysis limited to RBV free regimen in consideration RBV usage determined by provider and not study randomization.||5.5|-1.9|
70982885|NCT02786537|141474404|SUPERIORITY|Superiority test based on whether the 95% CI includes zero|Mean Difference (Net)|-1.0|||||TWO_SIDED|95.0|-4.6|2.7|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|RBV free SOF/LDV vs. PrOD regimens as reported in PRO (all patients who started treatment by arm as treated, population is limited to as randomization date of the last PrOD patient start date)||2.7|-4.6|
70982886|NCT02786537|141474405|SUPERIORITY|Superiority test comparison based on presence of zero in 95% CI.|Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-1.4|1.6|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method|Analysis limited to RBV free regimens in consideration that RBV usage determined by provider and not study randomization. All patients who started treatment by arm as treated.||1.6|-1.4|
70982887|NCT02786537|141474408|SUPERIORITY|Superiority test determined by comparing presence of zero in CI.|Mean Difference (Net)|-4.3|||||TWO_SIDED|95.0|-9.9|1.3|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method|Analysis based on RBV free regimens -all patients who started treatment by arm as treated, population is limited to as randomization date of the last PrOD patient start date.||1.3|-9.9|
71036746|NCT03629054|141581641|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|100.16|STANDARD_ERROR_OF_MEAN|8.6|<|0.0001|TWO_SIDED|90.0|96.17|104.31|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||104.31|96.17|<0.0001
70982888|NCT02786537|141474408|SUPERIORITY|Superiority comparison by viewing presence of zero in CI.|Mean Difference (Net)|3.0|||||TWO_SIDED|95.0|-3.4|9.4||||||RBV free regimens as reported in PRO (all patients who started treatment by arm as treated, population limited to as randomization date of the last PrOD patient start date)||9.4|-3.4|
70982889|NCT02786537|141474410|SUPERIORITY||Mean Difference (Net)|-0.7|||||TWO_SIDED|95.0|-3.6|2.1|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|Analysis based on RBV free regimens in consideration that RBV usage was determined by provider and not study randomization. Population includes patients who started treatment by arm as treated.||2.1|-3.6|
70982890|NCT02786537|141474419|EQUIVALENCE|Pre-specified equivalence range +/-5%|Mean Difference (Net)|-2.3|||||TWO_SIDED|95.0|-15.3|11.3||||||||11.3|-15.3|
70982891|NCT00443560|141474425|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.3|||<|0.01||95.0|2.3|4.5|||Chi-squared, Corrected|||||4.5|2.3|<0.01
70982892|NCT00443560|141474426|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.2|||<|0.01||95.0|9.9|15.0|||Chi-squared, Corrected|||||15.0|9.9|<0.01
70982893|NCT00443560|141474427|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.01
71036747|NCT03629054|141581642|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|92.57|STANDARD_ERROR_OF_MEAN|17.9||0.0029|TWO_SIDED|90.0|85.21|100.57|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||100.57|85.21|0.0029
70982894|NCT01494038|141474428|NON_INFERIORITY|Calculate the difference between the immediate arm incidence rate and the deferred arm incidence rate; if the upper bound of the 95% confidence interval is lower than a 5% difference in incidence rates, non-inferiority will be considered to be proven.|Incidence rate difference|0.1|||||TWO_SIDED|95.0|-4.77|4.98||||||||4.98|-4.77|
70982895|NCT01494038|141474429|SUPERIORITY|||||||0.093|||||||Fisher Exact|mid-P adjustment||||||0.093
70982896|NCT01494038|141474431|SUPERIORITY|||||||0.288|||||||Fisher Exact|mid-P adjustment||||||0.288
70982897|NCT01494038|141474432|SUPERIORITY|||||||0.073|||||||Fisher Exact|mid-P adjustment||||||0.073
70982898|NCT01494038|141474433|SUPERIORITY|||||||0.264|||||||Fisher Exact|mid-P adjustment||||||0.264
70982899|NCT01494038|141474434|SUPERIORITY|||||||0.012|||||||Fisher Exact|Mid-P adjustment||||||0.012
70982900|NCT01494038|141474437|SUPERIORITY|||||||0.279|||||||Fisher Exact|mid-P adjustment||||||0.279
70982901|NCT01494038|141474438|SUPERIORITY|||||||0.893|||||||Fisher Exact|mid-P adjustment||||||.893
70982902|NCT01494038|141474439|SUPERIORITY||Incidence rate difference|0.01|||||TWO_SIDED|95.0|-0.94|0.96||||||||0.96|-0.94|
70982903|NCT01494038|141474440|SUPERIORITY||Incidence rate difference|0.02|||||TWO_SIDED|95.0|-1.02|1.07||||||||1.07|-1.02|
70982904|NCT01494038|141474441|SUPERIORITY||Incidence rate difference|-1.43|||||TWO_SIDED|95.0|-4.17|1.32||||||||1.32|-4.17|
70982905|NCT01494038|141474442|SUPERIORITY||Incidence rate difference|-0.39|||||TWO_SIDED|95.0|-1.33|0.56||||||||0.56|-1.33|
70982906|NCT01494038|141474443|SUPERIORITY||Incidence rate difference|-0.38|||||TWO_SIDED|95.0|-1.72|0.97||||||||0.97|-1.72|
70982907|NCT01494038|141474444|SUPERIORITY||Incidence rate difference|-1.69|||||TWO_SIDED|95.0|-4.48|1.1||||||||1.1|-4.48|
70982908|NCT01494038|141474445|SUPERIORITY||Incidence rate difference|-1.3|||||TWO_SIDED|95.0|-3.86|1.25||||||||1.25|-3.86|
70982909|NCT01494038|141474446|SUPERIORITY||Incidence rate difference|2.14|||||TWO_SIDED|95.0|-7.86|12.13||||||||12.13|-7.86|
70982910|NCT01494038|141474447|SUPERIORITY||Incidence rate difference|6.89|||||TWO_SIDED|95.0|-0.08|13.86||||||||13.86|-0.08|
70982911|NCT01494038|141474448|SUPERIORITY||Incidence rate difference|5.49|||||TWO_SIDED|95.0|-13.7|24.68||||||||24.68|-13.7|
70982912|NCT01494038|141474449|SUPERIORITY||Incidence rate difference|15.88|||||TWO_SIDED|95.0|2.11|29.65||||||||29.65|2.11|
70982913|NCT01494038|141474450|SUPERIORITY||Incidence rate difference|-0.82|||||TWO_SIDED|95.0|-4.63|3.0||||||||3|-4.63|
70982914|NCT01494038|141474451|SUPERIORITY||Incidence rate difference|3.38|||||TWO_SIDED|95.0|-1.31|8.07||||||||8.07|-1.31|
70982915|NCT01494038|141474452|SUPERIORITY||Incidence rate difference|-0.82|||||TWO_SIDED|95.0|-4.63|3.0||||||||3|-4.63|
70982916|NCT01494038|141474453|SUPERIORITY||Incidence rate difference|3.39|||||TWO_SIDED|95.0|-1.46|8.25||||||||8.25|-1.46|
70982917|NCT01494038|141474454|SUPERIORITY||Incidence rate difference|-0.82|||||TWO_SIDED|95.0|-4.63|3.0||||||||3|-4.63|
70982918|NCT01494038|141474455|SUPERIORITY||Incidence rate difference|3.38|||||TWO_SIDED|95.0|-1.31|8.07||||||||8.07|-1.31|
70982919|NCT01494038|141474456|SUPERIORITY||Incidence rate difference|-0.82|||||TWO_SIDED|95.0|-4.63|3.0||||||||3|-4.63|
70982920|NCT01494038|141474457|SUPERIORITY||Incidence rate difference|3.39|||||TWO_SIDED|95.0|-1.46|8.25||||||||8.25|-1.46|
70982921|NCT01494038|141474462|OTHER|Measuring agreement between the tests|||||<|0.0001|||||||Chi-squared|McNemars test||||||< 0.0001
70982922|NCT01494038|141474462|OTHER|Agreement between tests|Kappa coefficient|0.42|||||TWO_SIDED|95.0|0.35|0.5||||||||0.50|0.35|
70982923|NCT01494038|141474463|OTHER|Agreement between tests||||||0.22|||||||Chi-squared|McNemar's test||||||0.22
70982924|NCT01494038|141474463|OTHER|Agreement between tests|Kappa coefficient|0.11|||||TWO_SIDED|95.0|0.001|0.21||||||||0.21|0.001|
70982925|NCT01494038|141474464|OTHER|Agreement between tests|||||<|0.0001|||||||Chi-squared|McNemar's test||||||< 0.0001
70982926|NCT01494038|141474464|OTHER|Agreement between tests|Kappa coefficient|0.46|||||TWO_SIDED|95.0|0.39|0.53||||||||0.53|0.39|
70982927|NCT05299892|141474467|OTHER||Mean Difference (Final Values)|6.46153||||0.005|TWO_SIDED|95.0|1.79|12.99|||ANOVA|||An ANOVA was conducted for the three SE conditions (off, moderate, strong) at 50 dBA .Post -hoc comparisons were done using Bonferroni's correction. Below result is the mean comparison between SE of and SE moderate. Analysis of age effects was not completed.||12.99|1.79|.005
70982928|NCT05299892|141474467|OTHER||Mean Difference (Final Values)|9.00961|||<|0.001|TWO_SIDED|95.0|3.91|15.11|||ANOVA|||An ANOVA was conducted for the three SE conditions (off, moderate, strong) at 50 dBA . Post -hoc comparisons were done using Bonferroni's correction. Below result is the mean comparison between SE of and SE strong. An analysis of age effects was not completed.||15.11|3.91|<.001
70982929|NCT05299892|141474467|OTHER||||||<|0.001|||||||t-test, 2 sided|||Null hypothesis: There will be no significant differences between the mean unaided CNC score at 50 dBA and the mean aided CNC score with SE off.||||<0.001
70982930|NCT01458340|141474469|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.69||0.6026|ONE_SIDED|95.0||3.2||α=0.05 significance level.|Mixed Model for Repeated Measures (MMRM)|One-sided p-values were obtained from the pairwise comparisons between TD-9855 group and placebo group based on the final model.||||3.2||0.6026
70982931|NCT01458340|141474469|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.69||0.4844|ONE_SIDED|95.0||2.7||α=0.05 significance level.|MMRM|One-sided p-values were obtained from the pairwise comparisons between TD-9855 group and placebo group based on the final model.||||2.7||0.4844
70982932|NCT01458340|141474470|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|2.17||0.5269|ONE_SIDED|95.0||3.7||α=0.05 significance level.|MMRM|One-sided p-values were obtained from the pairwise comparisons between TD-9855 group and placebo group based on the final model.||||3.7||0.5269
71097346|NCT02186171|141703665|SUPERIORITY|The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 12 months in total hip and femoral neck to maintain the overall significance level at 0.05.|LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.3|3.7||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA|||||3.7|2.3|< 0.0001
71097347|NCT02186171|141703666|SUPERIORITY|The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 12 months in total hip and femoral neck to maintain the overall significance level at 0.05.|LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|1.5|3.3||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA|||||3.3|1.5|< 0.0001
71097348|NCT02186171|141703667|SUPERIORITY|The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 6 months at the lumbar spine, total hip and femoral neck BMD in order to maintain the overall significance level at 0.05.|LS Mean Difference|8.7|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|7.6|9.7||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA|||||9.7|7.6|< 0.0001
71097349|NCT02186171|141703668|SUPERIORITY|The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 6 months at the lumbar spine, total hip and femoral neck BMD in order to maintain the overall significance level at 0.05.|LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|0.8|2.0||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA|||||2.0|0.8|< 0.0001
70982933|NCT01458340|141474470|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|2.16||0.2092|ONE_SIDED|95.0||1.8||α=0.05 significance level.|MMRM|One-sided p-values were obtained from the pairwise comparisons between TD-9855 group and placebo group based on the final model.||||1.8||0.2092
70982934|NCT03351244|141474519|OTHER||Hazard Ratio (HR)|1.097||||0.7735|TWO_SIDED|95.0|0.585|2.056|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||2.056|0.585|0.7735
70982935|NCT03351244|141474519|OTHER||Hazard Ratio (HR)|0.91||||0.7809|TWO_SIDED|95.0|0.468|1.77|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||1.770|0.468|0.7809
70982936|NCT03351244|141474519|OTHER||Hazard Ratio (HR)|1.005||||0.9862|TWO_SIDED|95.0|0.576|1.753|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||1.753|0.576|0.9862
70982937|NCT03351244|141474520|OTHER|A restricted maximum likelihood-based approach using a mixed model with repeated measurements was applied.|Placebo-corrected adjusted mean|0.38||||0.5289|TWO_SIDED|95.0|-0.809|1.57|||Mixed model with repeated measurements|The analysis included the fixed, categorical effects of treatment at each visit, and the fixed continuous effects of baseline at each visit.||||1.570|-0.809|0.5289
70982938|NCT03351244|141474520|OTHER|A restricted maximum likelihood-based approach using a mixed model with repeated measurements was applied.|Placebo-corrected adjusted mean|0.21||||0.744|TWO_SIDED|95.0|-1.055|1.475|||Mixed model with repeated measurements|The analysis included the fixed, categorical effects of treatment at each visit, and the fixed continuous effects of baseline at each visit.||||1.475|-1.055|0.7440
70982939|NCT03351244|141474520|OTHER|A restricted maximum likelihood-based approach using a mixed model with repeated measurements was applied.|Placebo-corrected adjusted mean|0.31||||0.5659|TWO_SIDED|95.0|-0.745|1.358|||Mixed model with repeated measurements|The analysis included the fixed, categorical effects of treatment at each visit, and the fixed continuous effects of baseline at each visit.||||1.358|-0.745|0.5659
70982940|NCT03351244|141474523|OTHER||Hazard Ratio (HR)|1.006||||0.9938|TWO_SIDED|95.0|0.203|4.989|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||4.989|0.203|0.9938
70982941|NCT03351244|141474523|OTHER||Hazard Ratio (HR)|1.116||||0.893|TWO_SIDED|95.0|0.225|5.531|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||5.531|0.225|0.8930
70982942|NCT03351244|141474523|OTHER||Hazard Ratio (HR)|1.058||||0.936|TWO_SIDED|95.0|0.265|4.233|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||4.233|0.265|0.9360
70982943|NCT03351244|141474525|OTHER||Hazard Ratio (HR)|0.788||||0.6362|TWO_SIDED|95.0|0.293|2.118|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||2.118|0.293|0.6362
71097350|NCT02186171|141703669|SUPERIORITY|The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 6 months at the lumbar spine, total hip and femoral neck BMD in order to maintain the overall significance level at 0.05.|LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.4|=|0.0033|TWO_SIDED|95.0|0.4|2.1||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA|||||2.1|0.4|= 0.0033
70982944|NCT03351244|141474525|OTHER||Hazard Ratio (HR)|0.612||||0.3782|TWO_SIDED|95.0|0.205|1.826|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||1.826|0.205|0.3782
70982945|NCT03351244|141474525|OTHER||Hazard Ratio (HR)|0.703||||0.4253|TWO_SIDED|95.0|0.296|1.671|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||1.671|0.296|0.4253
70982946|NCT00091793|141474535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|||<|0.0001||95.0|6.2|7.8|||ANCOVA|||||7.8|6.2|<0.0001
70982947|NCT01165229|141474549|OTHER|The efficacy of Herpes Zoster subunit (HZ/su) vaccine against herpes zoster disease was demonstrated if the lower limit (LL) of the two-sided 95% Confidence Interval (CI) of VE was above 10%.|Vaccine efficacy|90.02|||<|0.0001|TWO_SIDED|95.0|83.54|94.32|||Poisson exact test|||Comparison of vaccine efficacy in prevention of Herpes Zoster (HZ) disease between Zoster-022 GSK1437173A 70-79 YOA group and Zoster-022 Placebo 70-79 YOA group.||94.32|83.54|<0.0001
70982948|NCT01165229|141474549|OTHER|The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%|Vaccine efficacy|89.08|||<|0.0001|TWO_SIDED|95.0|74.65|96.16|||Poisson exact method|||Comparison of vaccine efficacy in prevention of Herpes Zoster (HZ) disease between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo Zoster-022 Placebo \>=80YOA Group||96.16|74.65|<0.0001
70982949|NCT01165229|141474549|OTHER|The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%|Vaccine efficacy|89.79|||<|0.0001|TWO_SIDED|95.0|84.29|93.66|||Poisson exact test|||Comparison of vaccine efficacy in prevention of Herpes Zoster (HZ) disease between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo \>=70YOA Group||93.66|84.29|<0.0001
70982950|NCT01165229|141474550|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|93.04|||<|0.0001|TWO_SIDED|95.0|72.47|99.19|||Poisson exact test|||Comparison of vaccine efficacy in prevention of Post-Herpetic Neuralgia (PHN) between Zoster-022/006 Pooled GSK1437173A 70-79YOA Group and Zoster-022/006 Pooled Placebo 70-79YOA Group||99.19|72.47|<0.0001
70982951|NCT01165229|141474550|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|71.16||||0.1844|TWO_SIDED|95.0|-51.51|97.08|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022/006 Pooled GSK1437173A \>=80YOA Group and Zoster-022/006 Pooled Placebo \>=80YOA Group||97.08|-51.51|0.1844
70982952|NCT01165229|141474550|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|88.78|||<|0.0001|TWO_SIDED|95.0|68.7|97.1|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022/006 Pooled GSK1437173A \>=70YOA Group and Zoster-022/006 Pooled Placebo \>=70YOA Group||97.10|68.70|<0.0001
70982953|NCT01165229|141474551|OTHER|The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%|Vaccine efficacy|91.27|||<|0.0001|TWO_SIDED|95.0|86.04|94.85|||Poisson exact test|||Comparison of vaccine efficacy in prevention of herpes zoster disease between Zoster-022/006 Pooled GSK1437173A 70-79YOA Group and Zoster-022/006 Pooled Placebo 70-79YOA Group||94.85|86.04|<0.0001
70982954|NCT01165229|141474551|OTHER|The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%|Vaccine efficacy|91.37|||<|0.0001|TWO_SIDED|95.0|80.22|96.94|||Poisson exact test|||Comparison of vaccine efficacy in prevention of herpes zoster disease between Zoster-022/006 Pooled GSK1437173A \>=80YOA Group and Zoster-022/006 Pooled Placebo \>=80YOA Group||96.94|80.22|<0.0001
70982955|NCT01165229|141474551|OTHER|The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%|Vaccine efficacy|91.3|||<|0.0001|TWO_SIDED|95.0|86.88|94.46|||Poisson exact test|||Comparison of vaccine efficacy in prevention of herpes zoster disease between Zoster-022/006 pooled GSK1437173A \>=70 YOA Group and Zoster-022/006 Pooled Placebo \>=70YOA Group||94.46|86.88|<0.0001
70982956|NCT01165229|141474552|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|90.8|||<|0.0001|TWO_SIDED|95.0|62.57|98.95|||Poisson exact test|||Comparison of of Vaccine Efficacy (VE) in prevention of PHN between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 placebo 70-79YOA Group||98.95|62.57|<0.0001
70982957|NCT01165229|141474552|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|65.76||||0.3072|TWO_SIDED|95.0|-91.58|96.62|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo \>=80YOA Group||96.62|-91.58|0.3072
70982958|NCT01165229|141474552|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|85.49|||<|0.0001|TWO_SIDED|95.0|58.52|96.3|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo \>=70YOA Group||96.30|58.52|<0.0001
70982959|NCT01165229|141474553|OTHER|The efficacy of HZ/su vaccine against duration of severe worst HZ associated pain was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|21.7||||0.3749|TWO_SIDED|95.0|-34.4|54.39|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group||54.39|-34.40|0.3749
70982960|NCT01165229|141474553|OTHER|The efficacy of HZ/su vaccine against duration of severe worst HZ associated pain was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|51.76||||0.2466|TWO_SIDED|95.0|-65.55|85.95|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo\>=80YOA Group||85.95|-65.55|0.2466
71097351|NCT06765889|141703674|OTHER||Bayes Factor (BF₁₀)|0.03|||||TWO_SIDED|||||||||||||
71097352|NCT06765889|141703677|OTHER||Mean (of both conditions)|4.17|||||TWO_SIDED|||||||||||||
70982961|NCT01165229|141474553|OTHER|The efficacy of HZ/su vaccine against duration of severe worst HZ associated pain was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|28.4||||0.1877|TWO_SIDED|95.0|-17.69|56.44|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo\>=70YOA Group||56.44|-17.69|0.1877
70982962|NCT01165229|141474556|OTHER|Efficacy of the HZ/su vaccine against overall and HZ related hospitalizations was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|100.0||||0.2533|TWO_SIDED|95.0|-144.13|100.0|||Poisson exact test|||Comparison of VE in reduction of overall and HZ related hospitalizations between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group||100.00|-144.13|0.2533
70982963|NCT01165229|141474556|OTHER|Efficacy of the HZ/su vaccine against overall and HZ related hospitalizations was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|100.0||||0.5024|TWO_SIDED|95.0|-435.14|100.0|||Poisson exact test|||Comparison of VE in reduction of overall and HZ related hospitalizations between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo \>=80YOA Group||100.00|-435.14|0.5024
70982964|NCT01165229|141474556|OTHER|Efficacy of the HZ/su vaccine against overall and HZ related hospitalizations was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|100.0||||0.0636|TWO_SIDED|95.0|-9.92|100.0|||Poisson exact test|||Comparison of VE in reduction of overall and HZ related hospitalizations between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo \>=70YOA Group||100.00|-9.92|0.0636
70982965|NCT01165229|141474557|OTHER|Efficacy of the HZ/su vaccine against HZ related complications was demonstrated if the LL of the VE was above 0%.|Vaccine efficacy|-65.69||||0.4947|TWO_SIDED|95.0|-827.06|73.62|||Poisson exact test|||Comparison of VE in reduction of HZ related complications between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group||73.62|-827.06|0.4947
70982966|NCT01165229|141474557|OTHER|Efficacy of the HZ/su vaccine against HZ related complications was demonstrated if the LL of the VE was above 0%|Vaccine efficacy|100.0||||1|TWO_SIDED|95.0|-558.05|100.0|||Poisson exact test|||Comparison of VE in reduction of HZ related complications between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo \>=80YOA Group||100.00|-558.05|1.0000
70982967|NCT01165229|141474557|OTHER|Efficacy of the HZ/su vaccine against HZ related complications was demonstrated if the LL of the VE was above 0%|Vaccine efficacy|0.97||||1|TWO_SIDED|95.0|-433.32|83.16|||Poisson exact test|||Comparison of VE in reduction of HZ related complications between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo \>=70YOA Group||83.16|-433.32|1.0000
70982968|NCT01165229|141474558|OTHER|Efficacy of the HZ/su vaccine against use of pain medications was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|43.42||||0.0112|TWO_SIDED|95.0|10.77|70.53|||Poisson exact test|||Comparison of VE in reduction in use of pain medication between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group||70.53|10.77|0.0112
70982969|NCT01165229|141474558|OTHER|Efficacy of the HZ/su vaccine against use of pain medications was demonstrated if the LL of the two-sided 95% CI of the VE was above 0%|Vaccine efficacy|27.03||||0.3903|TWO_SIDED|95.0|-26.43|73.2|||Poisson exact test|||Comparison of VE in reduction in use of pain medication between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo \>=80YOA Group||73.20|-26.43|0.3903
70982970|NCT01165229|141474558|OTHER|Efficacy of the HZ/su vaccine against use of pain medications was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|39.6||||0.0083|TWO_SIDED|95.0|10.79|64.75|||Poisson exact test|||Comparison of VE in reduction in use of pain medication between Zoster-022 GSK1437173A \>=70YOA group and Zoster-022 Placebo \>=70YOA Group||64.75|10.79|0.0083
70982971|NCT01165229|141474559|OTHER|Efficacy of the HZ/su vaccine against duration of pain medication associated with HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the hazard ratio was above 0%.|Vaccine efficacy|58.94||||0.0232|TWO_SIDED|95.0|11.45|80.96|||Poisson exact test|||Comparison of VE in reduction in duration of pain medication associated with HZ between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group||80.96|11.45|0.0232
70982972|NCT01165229|141474559|OTHER|Efficacy of the HZ/su vaccine against duration of pain medication associated with HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the hazard ratio was above 0%.|Vaccine efficacy|-14.56||||0.8324|TWO_SIDED|95.0|-303.3|67.46|||Poisson exact test|||Comparison of VE in reduction in duration of pain medication associated with HZ between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo \>=80YOA Group||67.46|-303.30|0.8324
70982973|NCT01165229|141474559|OTHER|Efficacy of the HZ/su vaccine against duration of pain medication associated with HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the hazard ratio was above 0%.|Vaccine efficacy|49.25||||0.0404|TWO_SIDED|95.0|2.92|73.47|||Poisson exact test|||Comparison of VE in reduction in duration of pain medication associated with HZ between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo \>=70YOA Group||73.47|2.92|0.0404
70982974|NCT01165229|141474568|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|100.0||||0.0081|TWO_SIDED|95.0|40.88|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022/006 Pooled GSK1437173A 50-59YOA Group and Zoster-022/006 Pooled Placebo 50-59YOA Group.Comparison of vaccine efficacy for groups 70-79 and above 80 YOA are presented in outcome measure 2.||100.00|40.88|0.0081
70982975|NCT01165229|141474568|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|100.0||||0.5097|TWO_SIDED|95.0|-442.83|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022/006 Pooled GSK1437173A 60-69YOA Group and Zoster-022/006 Pooled Placebo 60-69YOA Group||100.00|-442.83|0.5097
70982976|NCT01165229|141474569|OTHER|The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%|Vaccine efficacy|100.0||||1|TWO_SIDED|95.0|-649.86|100.0|||Poisson exact test|||Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A 50-59 YOA Group versus Zoster-022/006 Pooled Placebo 50-59 YOA Group||100.00|-649.86|1.0000
70982977|NCT01165229|141474569|OTHER|The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%|Vaccine efficacy|100.0||||1|TWO_SIDED|95.0|-3938.7|100.0|||Poisson exact test|||Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A 60-69 YOA Group versus Zoster-022/006 Pooled Placebo 60-69 YOA Group||100.00|-3938.70|1.0000
70982978|NCT01165229|141474569|OTHER|The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%|Vaccine efficacy|21.6||||1|TWO_SIDED|95.0|-149.41|78.91|||Poisson exact test|||Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A 70-79 YOA Group versus Zoster-022/006 Pooled Placebo 70-79 YOA Group||78.91|-149.41|1.0000
70982979|NCT01165229|141474569|OTHER|The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%|Vaccine efficacy|-223.81||||0.1528|TWO_SIDED|95.0|-883.05|18.84|||Poisson exact test|||Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A \>=80 YOA Group versus Zoster-022/006 Pooled Placebo\>=80 YOA Group||18.84|-883.05|0.1528
70982980|NCT01165229|141474569|OTHER|The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%|Vaccine efficacy|0.29||||0.5417|TWO_SIDED|95.0|-161.53|65.57|||Poisson exact test|||Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A \>=50 YOA Group versus Zoster-022/006 Pooled Placebo \>=50 YOA Group||65.57|-161.53|0.5417
70982981|NCT01165229|141474570|OTHER|The VE of HZ/su against duration of severe worst pain in subjects with confirmed HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|23.75||||0.2885|TWO_SIDED|95.0|-25.8|53.78|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022/006 pooled GSK1437173A 70-79YOA Group and Zoster-022/006 pooled Placebo 70-79YOA Group||53.78|-25.80|0.2885
70982982|NCT01165229|141474570|OTHER|The VE of HZ/su against duration of severe worst pain in subjects with confirmed HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|54.93||||0.194|TWO_SIDED|95.0|-50.03|86.46|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022/006 pooled GSK1437173A \>=80 YOA Group and Zoster-022/006 pooled Placebo \>=80 YOA Group||86.46|-50.03|0.1940
70982983|NCT01165229|141474570|OTHER|The VE of HZ/su against duration of severe worst pain in subjects with confirmed HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|30.48||||0.1243|TWO_SIDED|95.0|-10.52|56.27|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022/006 pooled GSK1437173A \>=70 YOA Group and Zoster-022/006 pooled Placebo\>=70 YOA Group||56.27|-10.52|0.1243
70982984|NCT00780403|141474627|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Statistical tests were performed at the significance level of 5%, without multiplicity adjustment.|Mainland-Gart Test|The p-value was derived from Mainland-Gart Test applied to a 2 (treatment sequence) by 2 (preferred period) contingency table.||The Mainland-Gart test was applied to the preference rates in the subjects who showed a preference, to assess the difference in preference rates between RediTab and Zyrtec.||||<0.0001
70982985|NCT03240081|141474651|NON_INFERIORITY|We set 2 points (20%) as the margin of difference when defining and evaluating non-inferiority in comparing the 2 arms at 4 weeks.|Median Difference (Final Values)|2.0||||0.08|TWO_SIDED|||||Threshold for significance \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.08
70982986|NCT03240081|141474652|NON_INFERIORITY|We set 2 points (20%) as the margin of difference when evaluating non-inferiority in comparing the 2 arms at 4 weeks.|Median Difference (Final Values)|2.0||||0.95|ONE_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.95
70982987|NCT01480180|141474654|OTHER||Poisson estimate|3.7|||<|0.001|TWO_SIDED|95.0|2.94|4.66||P-values are from the 1-sided test of the null hypothesis that the ABR is at least 8.5 evaluated at the 2.5% level.|Poisson regression|||The analysis is based on a Poisson regression model allowing for over-dispersion. For participants withdrawing prematurely, the log planned treatment duration is used as offset; for completers, the log actual treatment duration is used.||4.66|2.94|<0.001
70982988|NCT01480180|141474656|OTHER||Poisson estimate|3.27|||<|0.001|TWO_SIDED|95.0|2.59|4.11||P-values are from the 1-sided test of the null hypothesis that the ABR is at least 8.5 evaluated at the 2.5% level.|Poisson regression|||The analysis is based on a Poisson regression model allowing for over-dispersion. For participants withdrawing prematurely, the log planned treatment duration is used as offset; for completers, the log actual treatment duration is used.||4.11|2.59|<0.001
70982989|NCT01480180|141474658|OTHER||Poisson estimate|2.35|||<|0.001|TWO_SIDED|95.0|1.87|2.95||P-values are from the 1-sided test of the null hypothesis that the ABR is at least 8.5 evaluated at the 2.5% level.|Poisson regression|||The analysis is based on a Poisson regression model allowing for over-dispersion. For participants withdrawing prematurely, the log planned treatment duration is used as offset; for completers, the log actual treatment duration is used.||2.95|1.87|<0.001
70982990|NCT01480180|141474658|OTHER||Poisson estimate|4.39|||<|0.001|TWO_SIDED|95.0|3.09|6.24||P-values are from the 1-sided test of the null hypothesis that the ABR is at least 8.5 evaluated at the 2.5% level.|Poisson regression|||The analysis is based on a Poisson regression model allowing for over-dispersion. For participants withdrawing prematurely, the log planned treatment duration is used as offset; for completers, the log actual treatment duration is used.||6.24|3.09|<0.001
70982991|NCT03429075|141474757|EQUIVALENCE|ANCOVA||||||0.17|||||||ANCOVA|||||||0.17
70982992|NCT00524303|141474837|SUPERIORITY_OR_OTHER||Percent difference|-9.0|||||TWO_SIDED|95.0|-38.1|17.9|||||Approximate 95% confidence interval for the difference in response rates between the trastuzumab arm and the lapatinib arm was calculated.|||17.9|-38.1|
70982993|NCT00524303|141474837|SUPERIORITY_OR_OTHER||Percent difference|20.0|||||TWO_SIDED|95.0|-8.0|49.4|||||Approximate 95% confidence interval for the difference in response rates between the transtuzumab arm and the transtuzumab + lapatinib arm was calculated.|||49.4|-8.0|
70982994|NCT00524303|141474838|SUPERIORITY_OR_OTHER||Percent Difference|7.0||||0.627|TWO_SIDED|95.0|-17.8|32.5|||Fisher Exact||Approximate 95% confidence interval for the difference in response rates between the transtuzumab arm and the lapatinib arm was calculated.|||32.5|-17.8|0.627
70982995|NCT00524303|141474838|SUPERIORITY_OR_OTHER||Percent Difference|0.0||||1|TWO_SIDED|95.0|-25.1|25.1|||Fisher Exact||Approximate 95% confidence interval for the difference in response rates between the transtuzumab arm and the transtuzumab + lapatinib arm was calculated.|||25.1|-25.1|1.000
70982996|NCT01676116|141474893|SUPERIORITY_OR_OTHER||Treatment contrast|-0.94|||<|0.001|TWO_SIDED|95.0|-1.11|-0.78|||ANCOVA|||||-0.78|-1.11|<0.001
70982997|NCT00538642|141474934|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
70982998|NCT02975349|141474952|SUPERIORITY||Lesion rate ratio|1.45||||0.2947|TWO_SIDED|95.0|0.72|2.91|||Negative Binomial model|||||2.91|0.72|0.2947
70982999|NCT02975349|141474952|SUPERIORITY||Lesion rate ratio|0.3||||0.0015|TWO_SIDED|95.0|0.14|0.63|||Negative Binomial model|||||0.63|0.14|0.0015
70983000|NCT02975349|141474952|SUPERIORITY||Lesion rate ratio|0.44||||0.0313|TWO_SIDED|95.0|0.21|0.93|||Negative Binomial model|||||0.93|0.21|0.0313
70983001|NCT02975349|141474953|SUPERIORITY||Qualified relapse rate ratio|1.66||||0.2692|TWO_SIDED|95.0|0.67|4.09|||Negative Binomial model|||||4.09|0.67|0.2692
70983002|NCT02975349|141474953|SUPERIORITY||Qualified relapse rate ratio|0.31||||0.0896|TWO_SIDED|95.0|0.08|1.2|||Negative Binomial model|||||1.20|0.08|0.0896
70983003|NCT02975349|141474953|SUPERIORITY||Qualified relapse rate ratio|0.23||||0.0633|TWO_SIDED|95.0|0.05|1.09|||Negative Binomial model|||||1.09|0.05|0.0633
70983004|NCT02975349|141474954|SUPERIORITY||Odds Ratio (OR)|0.75||||0.5609|TWO_SIDED|95.0|0.29|1.95|||Logistic model|||||1.95|0.29|0.5609
70983005|NCT02975349|141474954|SUPERIORITY||Odds Ratio (OR)|2.79||||0.0689|TWO_SIDED|95.0|0.92|8.41|||Logistic model|||||8.41|0.92|0.0689
70983006|NCT02975349|141474954|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1767|TWO_SIDED|95.0|0.72|5.99|||Logistic model|||||5.99|0.72|0.1767
70983007|NCT02975349|141474955|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.407|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon rank-sum test|||||0.00|0.00|0.4070
70983008|NCT02975349|141474955|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.5829|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon rank-sum test|||||0.00|0.00|0.5829
70983009|NCT02975349|141474955|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.2732|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon rank-sum test|||||0.00|0.00|0.2732
70983010|NCT02975349|141474967|SUPERIORITY||Lesion rate ratio|1.36||||0.3676|TWO_SIDED|95.0|0.7|2.65|||Negative Binomial|||||2.65|0.70|0.3676
70983011|NCT02975349|141474967|SUPERIORITY||Lesion rate ratio|0.27||||0.0005|TWO_SIDED|95.0|0.13|0.57|||Negative Binomial|||||0.57|0.13|0.0005
70983012|NCT02975349|141474967|SUPERIORITY||Lesion rate ratio|0.41||||0.0157|TWO_SIDED|95.0|0.2|0.85|||Negative Binomial|||||0.85|0.20|0.0157
70983013|NCT02975349|141474968|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.9731|TWO_SIDED|95.0|-0.25|0.25|||Wilcoxon rank-sum test|||||0.25|-0.25|0.9731
70983014|NCT02975349|141474968|SUPERIORITY||Hodges-Lehmann estimate|-0.25||||0.0017|TWO_SIDED|95.0|-0.5|0.0|||Wilcoxon rank-sum test|||||0.00|-0.50|0.0017
70983015|NCT02975349|141474968|SUPERIORITY||Hodges-Lehmann estimate|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.75|-0.25|||Wilcoxon rank-sum test|||||-0.25|-0.75|< 0.0001
70983016|NCT02975349|141474969|SUPERIORITY||Lesion Rate ratio|1.29||||0.4807|TWO_SIDED|95.0|0.63|2.65|||Negative Binomial|||||2.65|0.63|0.4807
70983017|NCT02975349|141474969|SUPERIORITY||Lesion Rate ratio|0.5||||0.062|TWO_SIDED|95.0|0.24|1.04|||Negative Binomial|||||1.04|0.24|0.0620
70983018|NCT02975349|141474969|SUPERIORITY||Lesion Rate ratio|0.42||||0.0189|TWO_SIDED|95.0|0.2|0.87|||Negative Binomial|||||0.87|0.20|0.0189
70983019|NCT02975349|141474970|SUPERIORITY||Difference in least squares means|0.02||||0.8776|TWO_SIDED|95.0|-0.24|0.28|||Mixed Effect Model for Repeat Measures||Difference in least squares means of change from baseline in cube root of volume measured in centimeter.|||0.28|-0.24|0.8776
70983020|NCT02975349|141474970|SUPERIORITY||Difference in least squares means|-0.41||||0.0019|TWO_SIDED|95.0|-0.66|-0.15|||Mixed Effect Model for Repeat Measures||Difference in least squares means of change from baseline in cube root of volume measured in centimeter.|||-0.15|-0.66|0.0019
70983021|NCT02975349|141474970|SUPERIORITY||Difference in least squares means|-0.36||||0.0063|TWO_SIDED|95.0|-0.62|-0.1|||Mixed Effect Model for Repeat Measures||Difference in least squares means of change from baseline in cube root of volume measured in centimeter.|||-0.10|-0.62|0.0063
70983022|NCT02975349|141474971|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.9315|TWO_SIDED|95.0|-0.004|0.009|||Wilcoxon rank-sum test|||||0.009|-0.004|0.9315
70983023|NCT02975349|141474971|SUPERIORITY||Hodges-Lehmann estimate|-0.014||||0.0008|TWO_SIDED|95.0|-0.05|0.0|||Wilcoxon rank-sum test|||||0.000|-0.050|0.0008
70983024|NCT02975349|141474971|SUPERIORITY||Hodges-Lehmann estimate|-0.018||||0.0014|TWO_SIDED|95.0|-0.042|0.0|||Wilcoxon rank-sum test|||||0.000|-0.042|0.0014
70983025|NCT03191786|141475018|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.025|TWO_SIDED|95.0|0.63|0.97|||Log Rank|||Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.||0.97|0.63|0.025
70983026|NCT03191786|141475019|SUPERIORITY||Difference in OS Rates|6.5|||||TWO_SIDED|95.0|-3.3|16.3||||||OS Rate at 6 Months||16.3|-3.3|
70983027|NCT03191786|141475019|SUPERIORITY||Difference in OS Rates|5.1|||||TWO_SIDED|95.0|-4.9|15.0||||||OS Rate at 12 Months||15.0|-4.9|
70983028|NCT03191786|141475019|SUPERIORITY||Difference in OS Rates|7.4|||||TWO_SIDED|95.0|-1.6|16.5||||||OS Rate at 18 Months||16.5|-1.6|
70983029|NCT03191786|141475019|SUPERIORITY||Difference in OS Rates|11.9|||||TWO_SIDED|95.0|4.4|19.5||||||OS Rate at 24 Months||19.5|4.4|
70983030|NCT03191786|141475021|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.182|TWO_SIDED|95.0|0.7|1.07|||Log Rank|||Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.||1.07|0.70|0.182
70983031|NCT03191786|141475026|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|1.01||||0.975||95.0|0.57|1.78|||Log Rank|||Time to deterioration for Dyspnoea (single item QLQ-C30)||1.78|0.57|0.975
70983032|NCT03191786|141475026|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.89||||0.62|TWO_SIDED|95.0|0.55|1.42|||Log Rank|||Time to deterioration for Fatigue (multi items QLQ-C30)||1.42|0.55|0.620
70983033|NCT03191786|141475027|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|1.16||||0.653|TWO_SIDED|95.0|0.6|2.26|||Log Rank|||Time to deterioration for Cough (single item QLQ-LC13)||2.26|0.60|0.653
71097353|NCT05675020|141703707|OTHER|The descriptive analysis yields frequencies and percentages for categorical variables. The statistical analysis was conducted using IBM SPSS V27.0. We analyzed the percentage of correct responses for knowledge survey questions from pre- and post-intervention survey responses.|||||||||||||||||Participant data was collected from the REDCap pre- and post-intervention questionnaires completed by the adolescents and parents/legal guardians that participated in the project. Data was collected from October to December 2022. The sample size was nine parent-adolescent dyads. Descriptive analysis was used to assess differences in sociodemographic variables, including age, gender, race, material status, employment status, salary, height, and weight. The descriptive analysis yields frequencies and percentages for categorical variables. The statistical analysis was conducted using IBM SPSS V27.0.|||
71097354|NCT02014103|141703710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Astellas Ratio X 100|115.78|||||TWO_SIDED|90.0|107.04|125.22|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||125.22|107.04|
71097355|NCT02014103|141703710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr. Reddys/Astellas Ratio|103.7|||||TWO_SIDED|90.0|95.91|112.12|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||112.12|95.91|
71097356|NCT02014103|141703710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Astellas Ratio X 100|99.79|||||TWO_SIDED|90.0|92.3|107.89|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||107.89|92.30|
71097357|NCT02014103|141703710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Astellas Ratio|103.65|||||TWO_SIDED|90.0|95.83|112.11|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 and Cmax parameters||112.11|95.83|
71097358|NCT02014103|141703710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Sandoz/Astellas Ratio X100|101.7|||||TWO_SIDED|90.0|94.03|110.0|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 and parameters||110.0|94.03|
70983034|NCT03191786|141475027|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.51||||0.036|TWO_SIDED|95.0|0.27|0.97|||Log Rank|||Time to deterioration for Chest pain (single item QLQ-LC13)||0.97|0.27|0.036
70983035|NCT03191786|141475027|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.7||||0.125|TWO_SIDED|95.0|0.45|1.11|||Log Rank|||Time to deterioration for Dyspnoea (multiple items QLQ-LC13)||1.11|0.45|0.125
70983036|NCT03191786|141475027|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.75||||0.362|TWO_SIDED|95.0|0.41|1.39|||Log Rank|||Time to deterioration for Arm and/or shoulder pain (single item QLQ-LC13)||1.39|0.41|0.362
70983037|NCT03191786|141475027|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.68||||0.041|TWO_SIDED|95.0|0.46|0.99|||Log Rank|||Time to Confirmed Deterioration for the Composite of the 3 following symptoms: cough, dyspnoea (multi-items QLQ-LC13) and chest pain||0.99|0.46|0.041
70983038|NCT03191786|141475028|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.84||||0.272|TWO_SIDED|95.0|0.61|1.15|||Log Rank|||SP263 TC\>=1%||1.15|0.61|0.272
71097359|NCT02014103|141703710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Dr Reddys Ratio X 100|111.64|||||TWO_SIDED|90.0|103.26|120.7|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||120.70|103.26|
71097360|NCT02014103|141703710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Mylan Ratio X 100|116.02|||||TWO_SIDED|90.0|107.27|125.49|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||125.49|107.27|
71097361|NCT02014103|141703710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Panacea Ratio X 100|111.7|||||TWO_SIDED|90.0|103.27|120.81|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||120.81|103.27|
70983039|NCT03191786|141475029|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.87||||0.366|TWO_SIDED|95.0|0.64|1.18|||Log Rank|||SP263 TC\>=1%||1.18|0.64|0.366
70983040|NCT02082184|141475038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.114||0.8222|TWO_SIDED||||||ANCOVA|||||||0.8222
70983041|NCT02082184|141475039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.58||0.7925|TWO_SIDED||||||ANCOVA|||||||0.7925
70983042|NCT02082184|141475040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.134|<|0.001|TWO_SIDED||||||ANCOVA|||Statistical analysis of time spent \<70 mg/dL||||<0.001
70983043|NCT02082184|141475040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.068||0.0014|TWO_SIDED||||||ANCOVA|||Statistical analysis of time spent \<55 mg/dL||||0.0014
70983044|NCT02082184|141475041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.065||0.0164|TWO_SIDED||||||ANCOVA|||Statistical analysis of frequency of episodes \<70 mg/dL||||0.0164
70983045|NCT02082184|141475041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.037||0.0017|TWO_SIDED||||||ANCOVA|||Statistical analysis of frequency of episodes \<55 mg/dL||||0.0017
70983046|NCT02082184|141475042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.63||0.597|TWO_SIDED||||||ANCOVA|||Statistical analysis of time spent \>180 mg/dL||||0.5970
70983047|NCT02082184|141475042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.46||0.8729|TWO_SIDED||||||ANCOVA|||Statistical analysis of time spent \>240 mg/dL||||0.8729
70983048|NCT02082184|141475045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.31||0.6075|TWO_SIDED||||||ANCOVA|||Perceived frequency of hyperglycaemia||||0.6075
70983049|NCT02082184|141475045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.26||0.2295|TWO_SIDED||||||ANCOVA|||Perceived frequency of hypoglycaemia||||0.2295
70983050|NCT02082184|141475045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED||||||ANCOVA|||Total treatment satisfaction score||||<0.001
70983051|NCT01362322|141475056|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios \[Boostrix-Prev Group over Boostrix-New Group\] for anti-diphtheria (anti-D) antibodies was ≤ 1.5 (clinical limit for non-inferiority).|Adjusted radio|0.96|||||TWO_SIDED|95.0|0.85|1.09|||ANCOVA|||Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to diphteria vaccine antigens, one month after booster vaccination.||1.09|0.85|
70983052|NCT01362322|141475056|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios \[Boostrix-Prev Group over Boostrix-New Group\] for anti-tetanus (anti-T) antibodies was ≤ 1.5 (clinical limit for non-inferiority).|Adjusted Ratio|0.97|||||TWO_SIDED|95.0|0.86|1.1|||ANCOVA|||Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to tetanus vaccine antigens, one month after booster vaccination.||1.1|0.86|
70983053|NCT01362322|141475057|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios \[Boostrix-Prev Group over Boostrix-New Group\] for anti-pertussis toxoid (anti-PT) antibodies was ≤ 1.5 (clinical limit for non-inferiority).|Adjusted Ratio|0.92|||||TWO_SIDED|95.0|0.82|1.04|||ANCOVA|||Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to pertussis toxoid vaccine antigens, one month after booster vaccination.||1.04|0.82|
70983054|NCT01362322|141475057|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios \[Boostrix-Prev Group over Boostrix-New Group\] for anti-filamentous haemagglutinin (anti-FHA) antibodies was ≤ 1.5 (clinical limit for non-inferiority).|Adjusted Ratio|0.92|||||TWO_SIDED|95.0|0.83|1.03||||||Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to filamentous haemagglutinin vaccine antigens, one month after booster vaccination.||1.03|0.83|
70983055|NCT01362322|141475057|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios \[Boostrix-Prev Group over Boostrix-New Group\] for anti-pertactin (anti-PRN) antibodies was ≤ 1.5 (clinical limit for non-inferiority).|Adjusted ratio|0.98|||||TWO_SIDED|95.0|0.85|1.13||||||Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to pertactin vaccine antigens, one month after booster vaccination.||1.13|0.85|
70983056|NCT01009463|141475069|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.87||||0.181|TWO_SIDED|95.0|0.72|1.06|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||1.06|0.72|0.181
70983057|NCT01009463|141475069|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.66|||<|0.001|TWO_SIDED|95.0|0.54|0.81||Nominal p-value|Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||0.81|0.54|<0.001
70983058|NCT01009463|141475069|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.85||||0.109|TWO_SIDED|95.0|0.7|1.04|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||1.04|0.70|0.109
70983059|NCT01009463|141475070|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.43|TWO_SIDED|95.0|0.76|1.13|||Regression, Cox|||||1.13|0.76|0.430
70983060|NCT01009463|141475070|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.002|TWO_SIDED|95.0|0.59|0.89||Nominal p-value|Regression, Cox|||||0.89|0.59|0.002
70983061|NCT01009463|141475070|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.114|TWO_SIDED|95.0|0.69|1.04|||Regression, Cox|||||1.04|0.69|0.114
70983062|NCT01009463|141475071|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84||||0.125|TWO_SIDED|95.0|0.67|1.05|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||1.05|0.67|0.125
70983063|NCT01009463|141475071|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.62|||<|0.001|TWO_SIDED|95.0|0.49|0.78||Nominal p-value|Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable||||0.78|0.49|<0.001
70983064|NCT01009463|141475071|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81||||0.064|TWO_SIDED|95.0|0.64|1.01|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable||||1.01|0.64|0.064
70983065|NCT01009463|141475072|SUPERIORITY_OR_OTHER||Least squares mean difference|0.041||||0.011|TWO_SIDED|95.0|0.009|0.072||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.072|0.009|0.011
70983066|NCT01009463|141475072|SUPERIORITY_OR_OTHER||Least squares mean difference|0.058|||<|0.001|TWO_SIDED|95.0|0.027|0.09||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.090|0.027|<0.001
70983067|NCT01009463|141475072|SUPERIORITY_OR_OTHER||Least squares mean difference|0.064|||<|0.001|TWO_SIDED|95.0|0.033|0.096||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.096|0.033|<0.001
70983068|NCT00634543|141475075|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was demonstrated if lower confidence limit of 2-sided 95% CI was less than the non-inferiority margin of 1.39.|Mean Difference (Net)|0.39||||0.2143|TWO_SIDED|95.0|-0.23|1.01|||t-test, 2 sided|P-value was calculated for change from baseline in pain intensity score at Day 43.||||1.01|-0.23|0.2143
70983069|NCT00634543|141475076|SUPERIORITY_OR_OTHER|||||||0.7539|||||||Chi-squared|P-value was evaluated for pain relief in tramadol hydrochloride/ acetaminophen versus gabapentin groups at Day 15.||||||0.7539
70983070|NCT00634543|141475076|SUPERIORITY_OR_OTHER|||||||0.5905|||||||Chi-squared|P-value was evaluated for pain relief in tramadol hydrochloride/ acetaminophen versus gabapentin groups at Day 29.||||||0.5905
70983071|NCT00634543|141475076|SUPERIORITY_OR_OTHER|||||||0.7407|||||||Chi-squared|P-value was evaluated for pain relief in tramadol hydrochloride/ acetaminophen versus gabapentin groups at Day 43.||||||0.7407
70983072|NCT00634543|141475077|SUPERIORITY_OR_OTHER|||||||0.3504|||||||Chi-squared|P-value was evaluated for all categories (bad, no change, good and very good).||||||0.3504
70983073|NCT00634543|141475078|SUPERIORITY_OR_OTHER|||||||0.569|||||||Chi-squared|P-value was evaluated for all categories (bad, no change, good and very good).||||||0.5690
70983074|NCT00430781|141475090|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.535||90.0|0.65|1.7||Stratified log-rank test with one-sided p-value. p\<=0.0037 required for significance, and p\>0.4956 indicated futility.|Log Rank||The estimated value is the hazard ratio comparing combination to lapatinib monotherapy|||1.7|0.65|0.535
70983075|NCT00430781|141475093|SUPERIORITY_OR_OTHER|||||||0.237||95.0||||One-sided p-value.|Fisher Exact|||||||0.237
70983076|NCT00430781|141475097|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.66||||0.013||90.0|0.48|0.91||Stratified log-rank test with one-sided p-value.|Log Rank|||||0.91|0.48|0.013
70983077|NCT05099991|141475098|NON_INFERIORITY|Non-inferiority would be demonstrated with a mean increase in procedure of 5 minutes.|Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-7.8|8.2||||||||8.2|-7.8|
70983078|NCT05099991|141475099|OTHER|||||||0.07|||||||Fisher Exact|||||||0.07
70983079|NCT01389128|141475101|OTHER||||||<|0.01|||||||Chi-squared|||||||<0.01
70983080|NCT01389128|141475104|OTHER|||||||0.68|||||||Chi-squared|||||||0.68
70983081|NCT01521845|141475112|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.001
70983082|NCT01521845|141475113|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
70983083|NCT01521845|141475114|SUPERIORITY_OR_OTHER|||||||1||95.0|||||not comparable|||||||1
70983084|NCT01532453|141475115|SUPERIORITY_OR_OTHER|||||||0.0278|TWO_SIDED|||||Rank ANCOVA With treatment, center, gender, transplanted organ as factors and age of organ transplant as a covariable.|ANCOVA|||||||0.0278
70983085|NCT01532453|141475116|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.579|||<|0.05|TWO_SIDED|95.0|0.2703|1.2405|||ANCOVA|||||1.2405|0.2703|<0.05
70983086|NCT05483127|141475154|NON_INFERIORITY|Noninferiority in distance VA was declared if upper confidence limit was less than 0.05.|Least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.003|||ONE_SIDED|95.0||0.0||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, visit, lens by visit interaction, period, sequence) and random (subject) effects. Difference=P1fA - MDT. Sign (negative or positive) is retained with the rounded value.|||-0.00||
70983087|NCT00315302|141475155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|0.24||0.21||95.0|-0.2|0.8|||ANCOVA||The difference was calculated as atropine plus plano group minus atropine group|"The primary analysis was a treatment group comparison of logMAR visual acuity scores in the amblyopic eye obtained 18 weeks after randomization, adjusted for baseline acuity scores in an analysis of covariance (ANCOVA) model.~The primary analysis included only patients with visual acuity of 20/40 to 20/100; sample size was based upon a two-sided alpha of 0.05, with 90% power to detect a difference if the true difference in change from baseline between groups was 0.075 logMAR at 18 weeks."||0.8|-0.2|0.21
70983088|NCT00315302|141475156|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Regression, Logistic|proportion 20/25 as a function of treatment group controlling for baseline acuity||"Null hypothesis: proportion 20/25 or better at 18wks in atropine group = proportion 20/25 or better at 18wks in atropine plus plano group~Alternative hypothesis: proportion 20/25 or better at 18wks in atropine group NOT equal to proportion 20/25 or better at 18wks in atropine plus plano group"||||.03
70983089|NCT00315302|141475157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5|STANDARD_DEVIATION|3.1|||TWO_SIDED|95.0|3.2|5.8||||||95% confidence interval calculated within treatment group on the amount of change from baseline||5.8|3.2|
70983090|NCT00315302|141475157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|STANDARD_DEVIATION|3.7|||TWO_SIDED|95.0|3.7|6.4||||||95% confidence interval calculated within treatment group on the amount of change from baseline||6.4|3.7|
70983091|NCT00315302|141475158|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||Regression, Logistic|proportion 20/25 as a function of treatment group controlling for baseline acuity||"Null hypothesis: proportion 3 or more lines better at 18wks in atropine group = proportion 3 or more lines better at 18wks in atropine plus plano group~Alternative hypothesis: proportion 3 or more lines better at 18wks in atropine group NOT equal to proportion 3 or more lines better at 18wks in atropine plus plano group"||||0.39
70983092|NCT00315302|141475159|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test to evaluate difference in change from baseline in stereoacuity by treatment group||All patients without respect to cause of amblyopia.||||0.39
70983093|NCT00315302|141475160|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test to evaluate difference in change from baseline in stereoacuity by treatment group||Among anisometropic patients only||||0.90
70983094|NCT00315302|141475162|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||"Null hypothesis: proportion 1 or more lines worse and worse than 20/20 at 18wks same in both groups;~Alternate: proportion 1 or more lines worse and worse than 20/20 at 18wks same in both groups"||||0.003
70983095|NCT00440401|141475174|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Normal approximation to the binominal distribution is used to construct the asymptotic confidence intervals||||||<0.0001
70983096|NCT00440401|141475175|SUPERIORITY_OR_OTHER||||||<|0.0006||95.0|||||Cochran-Mantel-Haenszel|Normal approximation to the binominal distribution is used to construct the asymptotic confidence intervals||||||<0.0006
70983097|NCT00736229|141475200|SUPERIORITY_OR_OTHER||||||<|0.001||||||Comparison for the difference in Median glucose values during steady state across all three groups.|Kruskal-Wallis|||Median Glucose Values (mg/dl) after steady state were evaluated across the three groups (Exenatide,Moderate and Intensive) with a Kruskal-Wallis test.||||<0.001
70983098|NCT00736229|141475200|SUPERIORITY_OR_OTHER||||||<|0.001||||||Comparison of Median Glucose Values between Exenatide and Intensive Groups.|Wilcoxon (Mann-Whitney)|||Median Glucose Values (mg/dl) after steady state were evaluated between the Exenatide and Intensive study groups using a Wilcoxon Rank Sum tests.||||<0.001
70983099|NCT00736229|141475200|SUPERIORITY_OR_OTHER|||||||0.15||||||Comparison of Median Glucose Values between Exenatide and Moderate Groups.|Wilcoxon (Mann-Whitney)|||Median Glucose Values (mg/dl) after steady state were evaluated between the Exenatide and Moderate study groups using a Wilcoxon Rank Sum tests.||||0.15
70983100|NCT00736229|141475201|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Kruskal-Wallis|||Median Time (Hrs) to steady state was evaluated across the three groups (exenatide, moderate and intensive) with a Kruskal-Wallis test.||||<0.001
70983101|NCT00736229|141475201|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||Median time (hours) to steady state were evaluated between the Exenatide and Intensive study groups using a Wilcoxon Rank Sum tests.||||0.80
70983102|NCT00736229|141475201|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Median time (hours) to steady state were evaluated between the Exenatide and Moderate study groups using a Wilcoxon Rank Sum tests.||||<0.001
70983103|NCT00258154|141475216|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (Rotateq+INFANRIX hexa group minus Placebo+INFANRIX hexa group) for subjects who achieve serum antibody levels of ≥ 10 mIU/mL greater than -10%|Percentage point difference|0.0|||<|0.001||95.0|-3.7|3.6|||Miettinen and Nurminen's|Comparing percentage difference with the non-inferiority margin of 10 percentage point with Miettinen and Nurminen's method|Percentage point difference (RotaTeq - Placebo)|||3.6|-3.7|<0.001
70983104|NCT00258154|141475218|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (Rotateq+INFANRIX hexa group minus Placebo+INFANRIX hexa group) for subjects who achieve serum antibody levels of ≥ 0.15 μg/mL greater than -10%.|Percentage point difference|-3.7||||0.015||95.0|-9.3|1.3|||Miettinen and Nurminen's|Comparing percentage difference with the non-inferiority margin of 10 percentage point with Miettinen and Nurminen's method|Percentage point difference (RotaTeq - Placebo)|||1.3|-9.3|0.015
71036748|NCT03629054|141581643|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|97.33|STANDARD_ERROR_OF_MEAN|16.9||0.0001|TWO_SIDED|90.0|89.99|105.26|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||105.26|89.99|0.0001
71097362|NCT02014103|141703710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Sandoz Ratio X 100|113.84|||||TWO_SIDED|90.0|105.3|123.08|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||123.08|105.30|
70983105|NCT00754390|141475248|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Mixed Models Analysis|||Two-way mixed model analysis of variance was used to test for main effect of dietary calcium and phytate and their interaction. Null Hypothesis: Dietary calcium does not affect zinc absorption||||0.17
70983106|NCT00754390|141475248|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Mixed Models Analysis|||Two-way mixed model analysis of variance was used to test for main effect of dietary calcium and phytate and their interaction. Null Hypothesis: Dietary Phytate does not affect zinc absorption||||0.0002
70983107|NCT00754390|141475248|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Mixed Models Analysis|||Two-way mixed model analysis of variance was used to test for main effect of dietary calcium and phytate and their interaction. Null Hypothesis: Dietary calcium and dietary phytate do not affect zinc absorption. Eight women were required to detect a difference in zinc absorption of 7 percentage points with a power of 90%, alpha level of 0.05.||||0.09
71097363|NCT02014103|141703710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Mylan Ratio X 100|103.92|||||TWO_SIDED|90.0|96.08|112.4|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||112.40|96.08|
70983108|NCT00847613|141475249|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|36.48|||<|0.0001|TWO_SIDED|95.0|27.73|45.23||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690,550 to placebo.||45.23|27.73|<0.0001
70983109|NCT00847613|141475249|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|26.13|||<|0.0001|TWO_SIDED|95.0|17.28|34.97||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690,550 to placebo.||34.97|17.28|<0.0001
70983110|NCT00847613|141475250|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.0376|TWO_SIDED|95.0|-0.79|-0.02||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in ACR20 had to be significant.|Mixed Models Analysis|||Change at Month 6: Linear mixed model with treatment effect and site location as fixed effects and baseline value as covariate was used for the analysis.||-0.02|-0.79|0.0376
70983111|NCT00847613|141475250|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.2||0.0792|TWO_SIDED|95.0|-0.73|0.04||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in ACR20 had to be statistically significant.|Mixed Models Analysis|||Change at Month 6: Linear mixed model with treatment effect and site location as fixed effects and baseline value as covariate was used for the analysis.||0.04|-0.73|0.0792
70983112|NCT00847613|141475251|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.49|-0.31||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in mTSS had to be significant.|Mixed Models Analysis|||Change at Month 3: Least squares mean difference and corresponding 95% confidence interval (CI) was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.||-0.31|-0.49|<0.0001
70983113|NCT00847613|141475251|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.05||0.0002|TWO_SIDED|95.0|-0.34|-0.16||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in mTSS had to be statistically significant.|Mixed Models Analysis|||Change at Month 3: Least squares mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.||-0.16|-0.34|0.0002
70983114|NCT00847613|141475252|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|14.4|||<|0.0001|TWO_SIDED|95.0|9.44|19.36||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in HAQ-DI had to be significant.|Normal approximation|||Normal approximation to the binomial distribution was used to test the superiority of CP-690,550 10 mg to placebo and two-sided 95% CI was evaluated for the difference in percentages.||19.36|9.44|<0.0001
70983115|NCT00847613|141475252|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|5.61||||0.0034|TWO_SIDED|95.0|1.85|9.38||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.|Normal approximation|||Normal approximation to the binomial distribution was used to test the superiority of CP-690,550 10 mg to placebo and two-sided 95% CI was evaluated for the difference in percentages.||9.38|1.85|0.0034
70983116|NCT03443024|141475394|SUPERIORITY|||||||0.0165|||||||ANCOVA|||||||0.0165
70983117|NCT03443024|141475394|SUPERIORITY|||||||0.0022|TWO_SIDED|95.0|||||ANCOVA|||||||0.0022
70983118|NCT03443024|141475394|SUPERIORITY|||||||0.0005|TWO_SIDED|95.0|||||ANCOVA|||||||0.0005
70983119|NCT03443024|141475395|SUPERIORITY|||||||0.061|||||||Cochran-Mantel-Haenszel|||||||0.0610
70983120|NCT03443024|141475395|SUPERIORITY|||||||0.0021|||||||Cochran-Mantel-Haenszel|||||||0.0021
70983121|NCT03443024|141475395|SUPERIORITY|||||||0.0005|||||||Cochran-Mantel-Haenszel|||||||0.0005
70983122|NCT03443024|141475396|SUPERIORITY|||||||0.1917|||||||Cochran-Mantel-Haenszel|||||||0.1917
70983123|NCT03443024|141475396|SUPERIORITY|||||||0.0392|||||||Cochran-Mantel-Haenszel|||||||0.0392
70983124|NCT03443024|141475396|SUPERIORITY|||||||0.0023|||||||Cochran-Mantel-Haenszel|||||||0.0023
70983125|NCT03443024|141475397|SUPERIORITY|||||||0.2043|||||||Cochran-Mantel-Haenszel|||||||0.2043
70983126|NCT03443024|141475397|SUPERIORITY|||||||0.0021|||||||Cochran-Mantel-Haenszel|||||||0.0021
70983127|NCT03443024|141475397|SUPERIORITY|||||||0.0018|||||||Cochran-Mantel-Haenszel|||||||0.0018
70983128|NCT03443024|141475398|SUPERIORITY|||||||0.0554|||||||Cochran-Mantel-Haenszel|||||||0.0554
70983129|NCT03443024|141475398|SUPERIORITY|||||||0.0037|||||||Cochran-Mantel-Haenszel|||||||0.0037
70983130|NCT03443024|141475398|SUPERIORITY|||||||0.0008|||||||Cochran-Mantel-Haenszel|||||||0.0008
70983131|NCT03443024|141475399|SUPERIORITY|||||||0.08|||||||Cochran-Mantel-Haenszel|||||||0.0800
70983132|NCT03443024|141475399|SUPERIORITY|||||||0.0062|||||||Cochran-Mantel-Haenszel|||||||0.0062
70983133|NCT03443024|141475399|SUPERIORITY|||||||0.0006|||||||Cochran-Mantel-Haenszel|||||||0.0006
70983134|NCT03443024|141475400|SUPERIORITY|||||||0.0773|||||||ANCOVA|||||||0.0773
71097364|NCT02014103|141703710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Panacea Ratio x 100|100.05|||||TWO_SIDED|90.0|92.5|108.21|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||108.21|92.50|
71097365|NCT02014103|141703710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Sandoz Ratio X 100|101.97|||||TWO_SIDED|90.0|94.28|110.29|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||110.29|94.28|
70983135|NCT03443024|141475400|SUPERIORITY|||||||0.0459|||||||ANCOVA|||||||0.0459
70983136|NCT03443024|141475400|SUPERIORITY|||||||0.0062|TWO_SIDED|95.0|||||ANCOVA|||||||0.0062
70983137|NCT03443024|141475401|SUPERIORITY|||||||0.0047|||||||ANCOVA|||||||0.0047
70983138|NCT03443024|141475401|SUPERIORITY|||||||0.0002|TWO_SIDED|95.0|||||ANCOVA|||||||0.0002
70983139|NCT03443024|141475401|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70983140|NCT03443024|141475402|SUPERIORITY|||||||0.6674|||||||Cochran-Mantel-Haenszel|||||||0.6674
70983141|NCT03443024|141475402|SUPERIORITY|||||||0.1166|||||||Cochran-Mantel-Haenszel|||||||0.1166
70983142|NCT03443024|141475402|SUPERIORITY|||||||0.0119|||||||Cochran-Mantel-Haenszel|||||||0.0119
70983143|NCT03443024|141475403|SUPERIORITY|||||||0.2371|||||||Cochran-Mantel-Haenszel|||||||0.2371
70983144|NCT03443024|141475403|SUPERIORITY|||||||0.1067|||||||Cochran-Mantel-Haenszel|||||||0.1067
70983145|NCT03443024|141475403|SUPERIORITY|||||||0.0008|||||||Cochran-Mantel-Haenszel|||||||0.0008
70983146|NCT03443024|141475404|SUPERIORITY|||||||0.4631|||||||ANCOVA|||||||0.4631
70983147|NCT03443024|141475404|SUPERIORITY|||||||0.0368|||||||ANCOVA|||||||0.0368
70983148|NCT03443024|141475404|SUPERIORITY|||||||0.0232|||||||ANCOVA|||||||0.0232
70983149|NCT03443024|141475405|SUPERIORITY|||||||0.4729|||||||ANCOVA|||||||0.4729
70983150|NCT03443024|141475405|SUPERIORITY|||||||0.0282|||||||ANCOVA|||||||0.0282
70983151|NCT03443024|141475405|SUPERIORITY|||||||0.0506|||||||ANCOVA|||||||0.0506
70983152|NCT00624338|141475406|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.518|TWO_SIDED|95.0|0.74|1.82||Odds ratios were calculated from a logistic regression model adjusted for race and disease severity reported at screening.|Regression, Logistic|||||1.82|0.74|0.518
70983153|NCT00624338|141475406|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.003|TWO_SIDED|95.0|0.31|0.78||Odds ratios were calculated from a logistic regression model adjusted for race and disease severity reported at screening.|Regression, Logistic|Atacicept 150 mg arm was discontinued prematurely. The analysis of 150 mg was considered post-hoc.||||0.78|0.31|0.003
70983154|NCT00624338|141475407|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.984||||0.929|TWO_SIDED|95.0|0.69|1.4||Cox proportional hazards model was performed to calculate hazard ratios and adjusted for race and disease severity at time of screening.|Regression, Cox|||||1.40|0.69|0.929
70983155|NCT00624338|141475407|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.562||||0.009|TWO_SIDED|95.0|0.36|0.87||Cox proportional hazards model was performed to calculate hazard ratios and adjusted for race and disease severity at time of screening.|Regression, Cox|Atacicept 150 mg arm was discontinued prematurely. The analysis of 150 mg was considered post-hoc.||||0.87|0.36|0.009
70983156|NCT00624338|141475408|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.215||||0.412|TWO_SIDED|95.0|0.76|1.94||Odds ratios were calculated from a logistic regression model, adjusted for race and disease severity reported at screening.|Regression, Logistic|||||1.94|0.76|0.412
70983157|NCT00624338|141475408|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.722||||0.198|TWO_SIDED|95.0|0.44|1.19||Odds ratios were calculated from a logistic regression model, adjusted for race and disease severity reported at screening.|Regression, Logistic|Atacicept 150 mg arm was discontinued prematurely. The analysis of 150 mg was considered post-hoc.||||1.19|0.44|0.198
71097366|NCT02014103|141703710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Panacea Ratio X 100|96.28|||||TWO_SIDED|90.0|89.05|104.09|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||104.09|89.05|
70983158|NCT05593432|141475418|SUPERIORITY||Response Rate Difference|29.4|STANDARD_ERROR_OF_MEAN|11.17||0.0129|TWO_SIDED|95.0|7.55|51.33||stratified by Baseline Investigator's Global Assessment (IGA) score (3 or 4)|Cochran-Mantel-Haenszel||stratified by Baseline IGA score (3 or 4)|||51.33|7.55|0.0129
70983159|NCT05593432|141475418|SUPERIORITY||Odds Ratio (OR)|4.04|||||TWO_SIDED|95.0|1.32|12.38|||||stratified by Baseline IGA score (3 or 4)|||12.38|1.32|
70983160|NCT05593432|141475419|EQUIVALENCE|A Cochran-Mantel-Haenszel test stratified by Baseline IGA score (3 or 4) at a 2-sided α = 0.05 level was used for the comparison between ruxolitinib 1.5% cream BID and vehicle cream BID at Week 16.|Response Rate Difference|30.6|STANDARD_ERROR_OF_MEAN|11.68||0.0141|TWO_SIDED|95.0|7.71|53.51|||Cochran-Mantel-Haenszel|stratified by Baseline IGA score (3 or 4)||||53.51|7.71|0.0141
70983161|NCT05593432|141475419|EQUIVALENCE|A Cochran-Mantel-Haenszel test stratified by Baseline IGA score (3 or 4) at a 2-sided α = 0.05 level was used for the comparison between ruxolitinib 1.5% cream BID and vehicle cream BID at Week 16.|Odds Ratio (OR)|4.16|||||TWO_SIDED|95.0|1.31|13.17|||||stratified by Baseline IGA score (3 or 4)|||13.17|1.31|
70983162|NCT05593432|141475421|EQUIVALENCE|A Cochran-Mantel-Haenszel test stratified by Baseline IGA score (3 or 4) at a 2-sided α = 0.05 level was used for the comparison between ruxolitinib 1.5% cream BID and vehicle cream BID at Week 16.|Response Rate Difference|40.3|STANDARD_ERROR_OF_MEAN|12.09||0.0027|TWO_SIDED|95.0|16.61|64.0|||Cochran-Mantel-Haenszel|stratified by Baseline IGA score (3 or 4)||||64.00|16.61|0.0027
70983163|NCT05593432|141475421|EQUIVALENCE|A Cochran-Mantel-Haenszel test stratified by Baseline IGA score (3 or 4) at a 2-sided α = 0.05 level was used for the comparison between ruxolitinib 1.5% cream BID and vehicle cream BID at Week 16.|Odds Ratio (OR)|6.67|||||TWO_SIDED|95.0|1.85|24.02|||||stratified by Baseline IGA score (3 or 4)|||24.02|1.85|
70983164|NCT05593432|141475423|EQUIVALENCE|A log-rank test stratified by randomization stratification factor, Baseline IGA score (3 or 4), was used for between-treatment group comparisons. The hazard ratio and its 95% confidence interval was estimated based on the stratified Cox regression model. using Efron's method accounting for ties.|Hazard Ratio (HR)|2.85||||0.0008|TWO_SIDED|95.0|1.51|5.381|||Log Rank|stratified by Baseline IGA score (3 or 4) between ruxolitinib 1.5% cream and vehicle cream|Cox regression model stratified by Baseline IGA score (3 or 4) was conducted to compare the difference in hazard rate between ruxolitinib 1.5% cream and vehicle cream|||5.381|1.510|0.0008
70983165|NCT03476850|141475430|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.883|TWO_SIDED||||||Mixed Models Analysis|||An a priori sample size calculation found 24 subjects per group (48 total) provided \>80% power to detect a 2 unit difference in patient reported pain based on a 2-sided test and significance level a = 0.05 assuming at least 3 measures per subject and a within subject covariance having a compound symmetric structure with a standard deviation in pain score of 3 units and within subject correlation of 0.5.||||.883
70983166|NCT03476850|141475431|SUPERIORITY||Median Difference (Final Values)|0.25||||0.977|TWO_SIDED||||||ANOVA|||||||.977
70983167|NCT03476850|141475432|SUPERIORITY||Odds Ratio (OR)|4.9||||0.009|TWO_SIDED||||||Chi-squared|||||||.009
70983168|NCT03476850|141475434|SUPERIORITY||Median Difference (Final Values)|18.0||||0.11|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.110
70983169|NCT03476850|141475435|SUPERIORITY||Median Difference (Final Values)|0.26||||0.719|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.719
70983170|NCT02912364|141475436|OTHER||Mean Difference (Final Values)|0.23|||<|0.001|TWO_SIDED|95.0|0.13|0.34|||t-test, 2 sided|degrees of freedom = 22||||.34|.13|< .001
70983171|NCT02912364|141475437|OTHER||Mean Difference (Final Values)|0.54|||<|0.001|TWO_SIDED|95.0|0.3|0.79|||t-test, 2 sided|Degrees of freedom = 22.||||.79|.30|< .001
70983172|NCT04800315|141475473|SUPERIORITY||Mean Difference (Final Values)|-21.76||||0.003|TWO_SIDED|95.0|-35.81|-7.7|||ANCOVA|||||-7.70|-35.81|0.003
70983173|NCT04800315|141475473|SUPERIORITY||Mean Difference (Final Values)|-13.38||||0.057|TWO_SIDED|95.0|-27.19|0.43|||ANCOVA|||||0.43|-27.19|0.057
70983174|NCT04800315|141475473|SUPERIORITY||Mean Difference (Final Values)|-16.28||||0.029|TWO_SIDED|95.0|-30.88|-1.68|||ANCOVA|||||-1.68|-30.88|0.029
70983175|NCT04800315|141475474|OTHER|Risk Difference|Risk Difference VS Placebo|24.0||||0.004|TWO_SIDED|95.0|8.8|39.2|||Cochran-Mantel-Haenszel|||||39.2|8.8|0.004
70983176|NCT04800315|141475474|OTHER|Risk Difference|Risk Difference VS Placebo|15.3||||0.061|TWO_SIDED|95.0|0.8|29.8|||Cochran-Mantel-Haenszel|||||29.8|0.8|0.061
70983177|NCT04800315|141475474|OTHER|Risk Difference|Risk Difference VS Placebo|28.9|||<|0.001|TWO_SIDED|95.0|13.6|44.2|||Cochran-Mantel-Haenszel|||||44.2|13.6|<0.001
70983178|NCT04800315|141475475|OTHER|Risk Difference|Difference VS Placebo|23.7||||0.018|TWO_SIDED|95.0|6.2|41.2|||Cochran-Mantel-Haenszel|||||41.2|6.2|0.018
70983179|NCT04800315|141475475|OTHER|Risk Difference|Difference VS Placebo|21.8||||0.033|TWO_SIDED|95.0|4.3|39.3|||Cochran-Mantel-Haenszel|||||39.3|4.3|0.033
70983180|NCT04800315|141475475|OTHER|Risk Difference|Difference VS Placebo|26.7||||0.006|TWO_SIDED|95.0|9.3|44.0|||Cochran-Mantel-Haenszel|||||44.0|9.3|0.006
70983181|NCT04800315|141475476|OTHER|Risk Difference|Risk Difference|18.1|||||TWO_SIDED|95.0|2.3|33.9|||Cochran-Mantel-Haenszel|||||33.9|2.3|
70983182|NCT04800315|141475476|OTHER|Risk Difference|Risk Difference|10.5|||||TWO_SIDED|95.0|-4.6|25.7|||Cochran-Mantel-Haenszel|||||25.7|-4.6|
70983183|NCT04800315|141475476|SUPERIORITY||Risk Difference|15.9|||||TWO_SIDED|95.0|0.4|31.4|||Cochran-Mantel-Haenszel|||||31.4|0.4|
70983184|NCT04800315|141475477|SUPERIORITY||Mean Difference (Final Values)|-28.16|||||TWO_SIDED|95.0|-41.89|-14.44|||ANCOVA|||||-14.44|-41.89|
70983185|NCT04800315|141475477|SUPERIORITY||Mean Difference (Final Values)|-14.36|||||TWO_SIDED|95.0|-27.26|-1.46|||ANCOVA|||||-1.46|-27.26|
70983186|NCT04800315|141475477|SUPERIORITY||Mean Difference (Final Values)|-19.07|||||TWO_SIDED|95.0|-33.53|-4.62|||ANCOVA|||||-4.62|-33.53|
70983187|NCT04800315|141475478|OTHER|Adjusted Mean Difference VS Placebo|Adjusted Mean Difference VS Placebo|-22.5|||||TWO_SIDED|95.0|-41.46|-3.54|||ANCOVA|||||-3.54|-41.46|
70983188|NCT04800315|141475478|OTHER|Adjusted Mean Difference VS Placebo|Adjusted Mean Difference VS Placebo|-13.17|||||TWO_SIDED|95.0|-30.67|4.33|||ANCOVA|||||4.33|-30.67|
70983189|NCT04800315|141475478|OTHER|Adjusted Mean Difference VS Placebo|Adjusted Mean Difference VS Placebo|-16.32|||||TWO_SIDED|95.0|-36.4|3.75|||ANCOVA|||||3.75|-36.40|
71036749|NCT03629054|141581644|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|104.83|STANDARD_ERROR_OF_MEAN|13.2|<|0.0001|TWO_SIDED|90.0|98.56|111.5|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||111.50|98.56|<0.0001
71036750|NCT03629054|141581645|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|100.73|STANDARD_ERROR_OF_MEAN|5.1|<|0.0001|TWO_SIDED|90.0|98.33|103.18|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||103.18|98.33|<0.0001
71036751|NCT03629054|141581646|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|103.57|STANDARD_ERROR_OF_MEAN|14.3|<|0.0001|TWO_SIDED|90.0|96.9|110.71|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||110.71|96.90|<0.0001
71036752|NCT03629054|141581647|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|95.74|STANDARD_ERROR_OF_MEAN|7.8|<|0.0001|TWO_SIDED|90.0|92.29|99.32|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||99.32|92.29|<0.0001
71036753|NCT00205777|141581649|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.647||||0.22|TWO_SIDED|95.0|0.322|1.302|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% confidence intervals (CIs).||1.302|0.322|0.22
70983190|NCT04800315|141475479|OTHER|Risk Difference VS Placebo|Risk Difference VS Placebo|18.5||||0.042|TWO_SIDED|95.0|2.7|34.3|||Cochran-Mantel-Haenszel|||||34.3|2.7|0.042
70983191|NCT04800315|141475479|OTHER|Risk Difference VS Placebo|Risk Difference VS Placebo|19.9||||0.029|TWO_SIDED|95.0|4.1|35.7|||Cochran-Mantel-Haenszel|||||35.7|4.1|0.029
70983192|NCT04800315|141475479|OTHER|Risk Difference VS Placebo|Risk Difference VS Placebo|18.0||||0.052|TWO_SIDED|95.0|2.3|33.6|||Cochran-Mantel-Haenszel|||||33.6|2.3|0.052
70983193|NCT04800315|141475481|OTHER|Adjusted mean difference VS Placebo|Adjusted mean difference VS Placebo|-23.12|||||TWO_SIDED|95.0|-41.48|-4.76|||ANCOVA|||||-4.76|-41.48|
70983194|NCT04800315|141475481|OTHER|Adjusted mean difference VS Placebo|Adjusted mean difference VS Placebo|-8.28|||||TWO_SIDED|95.0|-25.16|8.59|||ANCOVA|||||8.59|-25.16|
70983195|NCT04800315|141475481|OTHER|Adjusted mean difference VS Placebo|Adjusted mean difference VS Placebo|-10.87|||||TWO_SIDED|95.0|-29.39|7.66|||ANCOVA|||||7.66|-29.39|
70983196|NCT01933672|141475516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.24|||||TWO_SIDED|80.0|-36.35|-26.12||||||Change from baseline||-26.12|-36.35|
70983197|NCT01933672|141475516|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-31.33|||||TWO_SIDED|80.0|-37.29|-25.37||||||Change from baseline||-25.37|-37.29|
70983198|NCT01933672|141475516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.24|||||TWO_SIDED|80.0|-24.99|-13.5||||||Change from baseline||-13.50|-24.99|
70983199|NCT01933672|141475516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.99|||||TWO_SIDED|80.0|-19.81|-4.17||||||There was no hypothesis to be tested. Difference in change from baseline in WMDG between the 2 treatment groups was calculated based on the mixed effects repeated measures model.||-4.17|-19.81|
71036754|NCT00205777|141581649|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.647||||0.24|TWO_SIDED|95.0|0.322|1.301|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg \[Core\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.301|0.322|0.24
70983200|NCT01933672|141475516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.09|||||TWO_SIDED|80.0|-19.81|-4.17||||||There was no hypothesis to be tested. Difference in change from baseline in WMDG between the 2 treatment groups was calculated based on the mixed effects repeated measures model.||-4.17|-19.81|
70983201|NCT01933672|141475517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.92|||||TWO_SIDED|80.0|-27.0|-16.85||||||Compared with Baseline||-16.85|-27.00|
70983202|NCT01933672|141475517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.7|||||TWO_SIDED|80.0|-26.3|-15.1||||||Compared with Baseline||-15.10|-26.30|
70983203|NCT01933672|141475517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.51|||||TWO_SIDED|80.0|-22.24|-10.78||||||Compared with Baseline||-10.78|-22.24|
70983204|NCT01933672|141475517|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-5.41|||||TWO_SIDED|80.0|-11.74|0.92||||||Change from baseline in FPG was analyzed in a mixed model analysis of covariance (ANCOVA) with regimen, period, sequence, treatment × period, and carryover as fixed effects. Subjects within sequences were modelled as random effects, with each subject's period-specific baseline response included, as fixed covariates.||0.92|-11.74|
70983205|NCT01933672|141475517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.19|||||TWO_SIDED|80.0|-10.86|2.49||||||Change from baseline in FPG was analyzed in a mixed model analysis of covariance (ANCOVA) with regimen, period, sequence, treatment × period, and carryover as fixed effects. Subjects within sequences were modelled as random effects, with each subject's period-specific baseline response included, as fixed covariates.||2.49|-10.86|
70983206|NCT01933672|141475518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|80.0|-0.19|0.07||||||Compared with Baseline （Pre-breakfast）||0.07|-0.19|
70983207|NCT01933672|141475518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|||||TWO_SIDED|80.0|-0.09|0.21||||||Compared with Baseline (Pre-breakfast)||0.21|-0.09|
70983208|NCT01933672|141475518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|80.0|0.16|0.45||||||Compared with Baseline (Pre-breakfast)||0.45|0.16|
70983209|NCT01933672|141475518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|80.0|-0.56|-0.36||||||Pre-breakfast; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||-0.36|-0.56|
70983210|NCT01933672|141475518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|||||TWO_SIDED|80.0|-0.45|-0.03||||||Pre-breakfast; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||-0.03|-0.45|
70983211|NCT01933672|141475518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|80.0|-0.08|0.48||||||Compared with Baseline (Pre-lunch)||0.48|-0.08|
70983212|NCT01933672|141475518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|||||TWO_SIDED|80.0|0.38|1.03||||||Compared with Baseline (Pre-lunch)||1.03|0.38|
70983213|NCT01933672|141475518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|||||TWO_SIDED|80.0|-0.26|0.37||||||Compared with Baseline (Pre-lunch)||0.37|-0.26|
70983214|NCT01933672|141475518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||||80.0|-0.28|0.57||||||Pre-lunch; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||0.57|-0.28|
70983215|NCT01933672|141475518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65|||||TWO_SIDED|80.0|0.19|1.11||||||Pre-lunch; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||1.11|0.19|
70983216|NCT01933672|141475518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.36|||||TWO_SIDED|80.0|0.03|0.68||||||Compared with Baseline (Pre-dinner)||0.68|0.03|
70983217|NCT01933672|141475518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|80.0|-0.08|0.67||||||Compared with Baseline (Pre-dinner)||0.67|-0.08|
70983218|NCT01933672|141475518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32|||||TWO_SIDED|80.0|-0.05|0.68||||||Compared with Baseline (Pre-dinner)||0.68|-0.05|
70983219|NCT01933672|141475518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|||||TWO_SIDED|80.0|-0.45|0.53||||||Pre-dinner; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||0.53|-0.45|
70983220|NCT01933672|141475518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|80.0|-0.55|0.51||||||Pre-dinner; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||0.51|-0.55|
70983221|NCT01933672|141475519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|||||TWO_SIDED|80.0|-0.75|1.07||||||Compared with Baseline （Pre-breakfast）||1.07|-0.75|
70983222|NCT01933672|141475519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46|||||TWO_SIDED|80.0|-0.58|1.51||||||Compared with Baseline (Pre-breakfast)||1.51|-0.58|
70983223|NCT01933672|141475519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|||||TWO_SIDED|80.0|0.58|2.63||||||Compared with Baseline (Pre-breakfast)||2.63|0.58|
70983224|NCT01933672|141475519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.45|||||TWO_SIDED|80.0|-2.84|-0.05||||||Pre-breakfast; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||-0.05|-2.84|
70983225|NCT01933672|141475519|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.14|||||TWO_SIDED|80.0|-2.63|0.35||||||Pre-breakfast; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||0.35|-2.63|
70983226|NCT01933672|141475519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.69|||||TWO_SIDED|80.0|-0.5|3.88||||||Compared with Baseline (Pre-lunch)||3.88|-0.50|
70983227|NCT01933672|141475519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.07|||||TWO_SIDED|80.0|1.56|6.58||||||Compared with Baseline (Pre-lunch)||6.58|1.56|
70983228|NCT01933672|141475519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|80.0|-2.42|2.4||||||Compared with Baseline (Pre-lunch)||2.40|-2.42|
70983229|NCT01933672|141475519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|||||TWO_SIDED|80.0|-1.62|5.01||||||Pre-lunch; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||5.01|-1.62|
70983230|NCT01933672|141475519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.08|||||TWO_SIDED|80.0|0.54|7.62||||||Pre-lunch; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||7.62|0.54|
70983231|NCT01933672|141475519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|80.0|-3.66|2.27||||||Compared with Baseline (Pre-dinner)||2.27|-3.66|
70983232|NCT01933672|141475519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.06|||||TWO_SIDED|80.0|1.7|8.43||||||Compared with Baseline (Pre-dinner)||8.43|1.70|
70983233|NCT01933672|141475519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.42|||||TWO_SIDED|80.0|-0.1|6.94||||||Compared with Baseline (Pre-dinner)||6.94|-0.10|
70983234|NCT01933672|141475519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.12|||||TWO_SIDED|80.0|-8.42|0.18||||||Pre-dinner; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||0.18|-8.42|
70983235|NCT01933672|141475519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.64|||||TWO_SIDED|80.0|-2.6|5.89||||||Pre-dinner; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||5.89|-2.60|
70983236|NCT01933672|141475522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|||||TWO_SIDED|80.0|0.21|1.39||||||Compared with baseline||1.39|0.21|
70983237|NCT01933672|141475522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||||TWO_SIDED|80.0|-0.43|0.93||||||Compared with baseline||0.93|-0.43|
70983238|NCT01933672|141475522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|||||TWO_SIDED|80.0|-0.92|0.4||||||Compared with baseline||0.40|-0.92|
70983239|NCT01933672|141475522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06|||||TWO_SIDED|80.0|0.17|1.95||||||||1.95|0.17|
70983240|NCT01933672|141475522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.51|||||TWO_SIDED|80.0|-0.45|1.47||||||||1.47|-0.45|
70983241|NCT02031146|141475556|OTHER|||||||0.29|||||||Two sample test of proportion in Stata|||||||0.29
70983242|NCT02031146|141475557|OTHER|||||||0.69|||||||Log Rank|||||||0.69
70983243|NCT02031146|141475558|OTHER|||||||0.04|||||||Log Rank|||||||0.04
70983244|NCT03167619|141475605|SUPERIORITY||MLE assuming exponential distribution|0.18||||0.0023|TWO_SIDED|95.0|0.11|0.27|||Chi-squared|Comparison to mean of historical control|Presence of patients with long PFS may have violated exponential assumption.|Assumed median PFS = 2.0 months as historical control, transformed to rate of 0.35/month||0.27|0.11|0.0023
70983245|NCT03167619|141475606|SUPERIORITY||MLE assuming exponential distribution|0.11|||<|0.0001|TWO_SIDED|95.0|0.07|0.19|||Chi-squared|Comparison to mean of historical control|Presence of patients with long PFS may have violated exponential assumption.|Assumed median PFS = 2.0 months as historical control, transformed to rate of 0.35/month||0.19|0.07|<0.0001
70983246|NCT02839746|141475635|OTHER||||||<|0.0001|||||||non-parametric Wilcoxon signed-rank|||Within group comparison of Baseline convenience with that of Visit 2.||||<0.0001
70983247|NCT02839746|141475635|OTHER||||||<|0.0001|||||||non-parametric Wilcoxon signed-rank|||Within group comparison of Baseline satisfaction with that of Visit 2.||||<0.0001
70983248|NCT02839746|141475636|OTHER||||||<|0.0001|||||||non-parametric Wilcoxon signed-rank|||Within group comparison of Baseline convenience with that of Visit 3.||||<0.0001
70983249|NCT02839746|141475636|OTHER|Within group comparison of Baseline satisfaction with that of Visit 3.|||||<|0.0001|||||||non-parametric Wilcoxon signed-rank]|||||||<0.0001
70983250|NCT02839746|141475637|OTHER||||||<|0.0001|||||||non-parametric Wilcoxon signed-rank|||Within group comparison of visit 2 convenience with that of Visit 3.||||<0.0001
70983251|NCT02839746|141475637|OTHER||||||<|0.0001|||||||non-parametric Wilcoxon signed-rank|||Within group comparison of visit 2 satisfaction with that of Visit 3.||||<0.0001
71036755|NCT00205777|141581649|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.097||||0.83|TWO_SIDED|95.0|0.501|2.405|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg \[Core\] versus Raloxifene 60 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||2.405|0.501|0.83
70983252|NCT02767570|141475648|SUPERIORITY||Mean Difference (Net)|-1.2||||0.001|TWO_SIDED|95.0|-1.9|-0.5||The threshold for statistical significance was p=0.05.|Regression, Linear||Difference = Altered FPA - Consistent FPA|For the primary hypothesis that there would be a greater reduction in pain for the altered compared to the consistent FPA group, an effect size of 0.57 was assumed. To achieve 80% power with an alpha of 0.05, 39 participants per group were needed, so our recruitment goal was 40 subjects per group.||-0.5|-1.9|0.001
70983253|NCT02767570|141475649|SUPERIORITY||Mean Difference (Net)|-0.26|||<|0.001|TWO_SIDED|95.0|-0.39|-0.13||The threshold for statistical significance was p=0.05.|Regression, Linear||Difference = Altered FPA - Consistent FPA|||-0.13|-0.39|<0.001
70983254|NCT02767570|141475650|SUPERIORITY||Mean Difference (Net)|-3.74||||0.006|TWO_SIDED|95.0|-6.42|-1.05||The threshold for statistical significance was p=0.05.|Regression, Linear||Difference = Altered FPA - Consistent FPA|||-1.05|-6.42|0.006
71036756|NCT00205777|141581649|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.074||||0.87|TWO_SIDED|95.0|0.49|2.356|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Raloxifene 60 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||2.356|0.490|0.87
71036757|NCT00205777|141581649|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.988||||0.96|TWO_SIDED|95.0|0.458|2.131|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||2.131|0.458|0.96
71036758|NCT00205777|141581649|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.592||||0.16|TWO_SIDED|95.0|0.289|1.212|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Raloxifene 60 mg \[Core\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.212|0.289|0.16
71036759|NCT00205777|141581649|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.551||||0.035|TWO_SIDED|95.0|0.324|0.937|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||0.937|0.324|0.035
70983255|NCT02767570|141475651|SUPERIORITY||Mean Difference (Net)|-0.06||||0.93|TWO_SIDED|95.0|-1.42|1.3||The threshold for statistical significance was p=0.05.|Regression, Linear||Difference = Altered FPA - Consistent FPA|||1.30|-1.42|0.93
71036760|NCT00205777|141581649|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.624||||0.07|TWO_SIDED|95.0|0.373|1.045|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg \[Core\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.045|0.373|0.070
70983256|NCT02767570|141475652|SUPERIORITY||Mean Difference (Net)|-0.29||||0.85|TWO_SIDED|95.0|-3.38|2.8||The threshold for statistical significance was p=0.05.|Regression, Linear||Difference = Altered FPA - Consistent FPA|||2.80|-3.38|0.85
70983257|NCT02767570|141475653|SUPERIORITY||Mean Difference (Net)|0.0||||0.99|TWO_SIDED|95.0|-0.89|0.9||The threshold for statistical significance was p=0.05.|Regression, Linear||Difference = Altered FPA - Consistent FPA|||0.90|-0.89|0.99
70983258|NCT00151411|141475654|SUPERIORITY||Mean Difference (Final Values)|4.3||||0.54|TWO_SIDED|95.0|-9.9|18.4|||Mixed Models Analysis|||||18.4|-9.9|0.54
70983259|NCT00151411|141475655|SUPERIORITY||Rate Ratio|2.5||||0.07|TWO_SIDED|95.0|0.9|6.6|||Zero-altered negative binomial model||Placebo is the reference group, i.e. for the rate ratio, Metformin represents the numerator and Placebo the denominator.|This statistical analysis models the probability of ovulation.||6.6|0.9|0.07
70983260|NCT00151411|141475655|SUPERIORITY||rate ratio|1.2||||0.51|TWO_SIDED|95.0|0.7|1.9|||Zero-altered negative binomial model||Placebo is the reference group, i.e. for the rate ratio, Metformin represents the numerator and Placebo the denominator.|This statistical analysis models the count of ovulations provided a woman actually ovulated.||1.9|0.7|0.51
70983261|NCT00151411|141475656|SUPERIORITY||Mean Difference (Final Values)|4.6||||0.05|TWO_SIDED|95.0|0.1|9.0|||Mixed Models Analysis|||||9.0|0.1|0.05
71036761|NCT00205777|141581649|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.085||||0.79|TWO_SIDED|95.0|0.605|1.947|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg \[Core\] versus Raloxifene 60 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.947|0.605|0.79
71036762|NCT00205777|141581649|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.959||||0.99|TWO_SIDED|95.0|0.527|1.743|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Raloxifene 60 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.743|0.527|0.99
70983262|NCT01819935|141475662|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.72|1.2||||||Propensity Cox proportional hazards regression model was used.||1.20|0.72|
70983263|NCT01819935|141475663|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.53|1.05||||||Propensity Cox proportional hazards regression model was used.||1.05|0.53|
70983264|NCT01819935|141475664|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.9|1.15||||||Propensity Cox proportional hazards regression model was used.||1.15|0.90|
70983265|NCT01819935|141475665|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.39|1.09||||||Propensity Cox proportional hazards regression model was used.||1.09|0.39|
70983266|NCT01819935|141475666|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.68|1.37||||||Propensity Cox proportional hazards regression model was used.||1.37|0.68|
70983267|NCT01819935|141475667|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.68|1.13||||||Propensity Cox proportional hazards regression model was used.||1.13|0.68|
70983268|NCT01819935|141475668|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.54|1.48||||||Propensity Cox proportional hazards regression model was used.||1.48|0.54|
70983269|NCT01819935|141475669|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|1.06|1.45||||||Propensity Cox proportional hazards regression model was used.||1.45|1.06|
70983270|NCT01157169|141475670|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|110.49|||||TWO_SIDED|90.0|101.67|120.07|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||120.07|101.67|
70983271|NCT01157169|141475671|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.91|||||TWO_SIDED|90.0|99.74|112.45|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||112.45|99.74|
70983272|NCT01157169|141475672|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.97|||||TWO_SIDED|90.0|97.18|111.24|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||111.24|97.18|
70983273|NCT01157169|141475673|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|93.28|||||TWO_SIDED|90.0|85.37|101.93|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101.93|85.37|
70983274|NCT01157169|141475674|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|94.19|||||TWO_SIDED|90.0|87.44|101.46|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101.46|87.44|
70983275|NCT01157169|141475675|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.06|||||TWO_SIDED|90.0|86.56|104.39|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||104.39|86.56|
70983276|NCT02396147|141475683|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|87.09|||||TWO_SIDED|90.0|58.56|129.52|||||T4 Formulation B Fasted (test)/T2 Formulation Fasted (reference)\*100|||129.52|58.56|
70983277|NCT02396147|141475683|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|83.09|||||TWO_SIDED|90.0|59.95|115.18|||||T4 Formulation C Fasted (test)/T2 Formulation Fasted (reference) \* 100|||115.18|59.95|
70983278|NCT02396147|141475683|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|78.59|||||TWO_SIDED|90.0|52.88|116.79|||||T4 Formulation B Fed (test)/T4 Formulation B Fasted (reference) \* 100|||116.79|52.88|
70983279|NCT02396147|141475683|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|94.23|||||TWO_SIDED|90.0|67.98|130.61|||||T4 Formulation C Fed (test)/T4 Formulation C Fasted (reference) \* 100|||130.61|67.98|
70983280|NCT02396147|141475684|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|94.53|||||TWO_SIDED|90.0|74.83|119.4|||||T4 Formulation B Fasted (test)/T2 Formulation Fasted (Reference) \*100|||119.40|74.83|
70983281|NCT02396147|141475684|SUPERIORITY_OR_OTHER||Geometric Mean Ration|77.99|||||TWO_SIDED|90.0|64.29|94.61|||||T4 Formulation C Fasted (test)/T2 Formulation Fasted (reference) \* 100|||94.61|64.29|
70983282|NCT02396147|141475684|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|81.08|||||TWO_SIDED|90.0|64.21|102.37|||||T4 Formulation B Fed (test)/T4 Formulation B Fasted (reference) \* 100|||102.37|64.21|
70983283|NCT02396147|141475684|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|92.78|||||TWO_SIDED|90.0|76.48|112.55|||||T4 Formulation C Fed (test)/T4 Formulation C Fasted (reference) \* 100|||112.55|76.48|
70983284|NCT02396147|141475685|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|94.43|||||TWO_SIDED|90.0|74.85|119.12|||||T4 Formulation B Fasted (test)/T2 Formulation Fasted (reference) \* 100|||119.12|74.85|
70983285|NCT02396147|141475685|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|78.09|||||TWO_SIDED|90.0|64.53|94.51|||||T4 Formulation C Fasted (test)/T2 Formulation Fasted (reference) \* 100|||94.51|64.53|
70983286|NCT02396147|141475685|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|81.16|||||TWO_SIDED|90.0|64.36|102.34|||||T4 Formulation B Fed (test)/T4 Formulation B Fasted (reference) \* 100|||102.34|64.36|
70983287|NCT02396147|141475685|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|92.99|||||TWO_SIDED|90.0|76.84|112.54|||||T4 Formulation C Fed (test)/T4 Formulation C Fasted (reference) \* 100|||112.54|76.84|
71036763|NCT00205777|141581649|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.882||||0.78|TWO_SIDED|95.0|0.488|1.593|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.593|0.488|0.78
71036764|NCT00205777|141581649|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.574||||0.036|TWO_SIDED|95.0|0.34|0.968|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Raloxifene 60 mg \[Core\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||0.968|0.340|0.036
71036765|NCT00205777|141581650|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.097|TWO_SIDED|95.0|0.339|1.099|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.099|0.339|0.097
71036766|NCT00205777|141581650|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.645||||0.15|TWO_SIDED|95.0|0.361|1.151|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40/20 mg \[SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.151|0.361|0.15
70983288|NCT02413398|141475700|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.53|-0.15|||Mixed Models Analysis|||Difference in adjusted mean change from baseline (MMRM model)||-0.15|-0.53|<0.001
70983289|NCT02413398|141475701|SUPERIORITY||Mean Difference (Final Values)|-1.43|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.15|-0.69|||Mixed Models Analysis|||Difference in adjusted mean percent change from baseline (MMRM)||-0.69|-2.15|<0.001
70983290|NCT02413398|141475702|SUPERIORITY||Mean Difference (Final Values)|-16.59|STANDARD_ERROR_OF_MEAN|5.15||0.001|TWO_SIDED|95.0|-26.73|-6.45|||Mixed Models Analysis|||Difference in adjusted mean change from baseline versus placebo (MMRM)||-6.45|-26.73|0.001
70983291|NCT02413398|141475703|SUPERIORITY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|1.6|<|0.05|TWO_SIDED|95.0|-6.3|0.0|||Mixed Models Analysis|||Difference in adjusted mean change from baseline vs. placebo (MMRM)||0.0|-6.3|<0.050
70983292|NCT02874794|141475704|SUPERIORITY||Median Difference (Final Values)|-2.2||||0.7827|TWO_SIDED|95.0|-17.6|13.2|||ANCOVA|||||13.2|-17.6|0.7827
70983293|NCT02874794|141475707|SUPERIORITY||Ratio of Geometric Means|0.6667|||<|0.0001|TWO_SIDED|95.0|0.5858|0.7589|||ANCOVA|||||0.7589|0.5858|<.0001
70983294|NCT02874794|141475708|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.5792|TWO_SIDED|95.0|-0.58|0.33|||ANCOVA|||||0.33|-0.58|0.5792
70983295|NCT02874794|141475709|SUPERIORITY||Mean Difference (Final Values)|-2.8|||<|0.0001|TWO_SIDED|95.0|-4.02|-1.59|||ANCOVA|||||-1.59|-4.02|<.0001
70983296|NCT02874794|141475710|SUPERIORITY||Median Difference (Final Values)|-0.03||||0.8617|TWO_SIDED|95.0|-0.33|0.27|||ANCOVA|||||0.27|-0.33|0.8617
70983297|NCT02874794|141475711|SUPERIORITY||Median Difference (Final Values)|-1.75||||0.0007|TWO_SIDED|95.0|-2.76|-0.75|||ANCOVA|||vs Enalapril||-0.75|-2.76|0.0007
70983298|NCT02874794|141475712|SUPERIORITY||Median Difference (Final Values)|0.63||||0.2354|TWO_SIDED|95.0|-0.41|1.68|||ANCOVA|||||1.68|-0.41|0.2354
70983299|NCT02874794|141475713|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.8215|TWO_SIDED|95.0|-0.05|0.04|||ANCOVA|||||0.04|-0.05|0.8215
70983300|NCT02874794|141475714|SUPERIORITY||Median Difference (Final Values)|-1.58||||0.0452|TWO_SIDED|95.0|-3.13|-0.03|||ANCOVA|||||-0.03|-3.13|0.0452
70983301|NCT02874794|141475715|SUPERIORITY||Mean Difference (Final Values)|-1.97||||0.0242|TWO_SIDED|95.0|-3.68|-0.26|||ANCOVA|||||-0.26|-3.68|0.0242
71036767|NCT00205777|141581650|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.941||||0.83|TWO_SIDED|95.0|0.493|1.793|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40/20 mg \[SE I\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.793|0.493|0.83
71036768|NCT00205777|141581650|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.666||||0.067|TWO_SIDED|95.0|0.435|1.019|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.019|0.435|0.067
71097367|NCT02014103|141703710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Sandoz Ratio X 100|98.12|||||TWO_SIDED|90.0|90.72|106.12|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||106.12|90.72|
70983302|NCT00537940|141475716|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.8708|TWO_SIDED|95.0|-6.0|7.0|||Ranked ANCOVA|||Rank analysis of covariance (ANCOVA) model was used to derive p-value with treatment as main effect and cluster as cofactor, percent change in 28-day seizure counts between Baseline and treatment periods as dependent variable. Median differences and 95% confidence interval (CI) were based on Hodges-Lehmann estimation.||7.0|-6.0|0.8708
70983303|NCT00537940|141475717|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.92||||0.662|TWO_SIDED|95.0|0.635|1.335|||Regression, Logistic|||The odds ratio and its 95% CI are calculated by exponentiating the log odds ratio and 95% CI that correspond to the treatment contrast in the logistic regression model with treatment as fixed effect and Baseline term and country as covariate. All statistical tests for secondary efficacy parameters were two sided and performed at significance level of α = 0.05. The above statistical analysis applies to All Partial Seizures - FAS Population.||1.335|0.635|0.662
70983304|NCT00537940|141475718|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9232|TWO_SIDED|||||All partial seizure: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.9232
70983305|NCT00537940|141475718|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6361|TWO_SIDED|||||Simple Partial: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.6361
70983306|NCT00537940|141475718|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9075|TWO_SIDED|||||Complex partial: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.9075
70983307|NCT00537940|141475718|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4203|TWO_SIDED|||||SGTC seizure: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.4203
70983308|NCT00537940|141475719|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5069|TWO_SIDED|||||All partial seizure: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.5069
70983309|NCT00537940|141475719|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4721|TWO_SIDED|||||Simple partial seizure: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.4721
70983310|NCT00537940|141475719|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6054|TWO_SIDED|||||Complex partial seizure: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.6054
70983311|NCT00537940|141475719|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6603|TWO_SIDED|||||SGTC seizure: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.6603
70983312|NCT00537940|141475721|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1881|TWO_SIDED|||||p-value is calculated using Fisher Exact Test.|Fisher Exact|||||||0.1881
70983313|NCT00537940|141475722|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.38||0.5643|TWO_SIDED|95.0|-0.53|0.97|||ANCOVA|||Baseline, HADS-A: ANCOVA model was used to calculate least square (LS) mean estimates of the treatment difference along with 95% CI, with main effects of treatment and and country as covariates.||0.97|-0.53|0.5643
70983314|NCT00537940|141475722|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.32||0.7712|TWO_SIDED|95.0|-0.73|0.54|||ANCOVA|||Change at Week 21 / ET , HADS-A: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country as covariates.||0.54|-0.73|0.7712
70983315|NCT00537940|141475722|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.35||0.4236|TWO_SIDED|95.0|-0.41|0.97|||Ranked ANCOVA|||Baseline, HADS-D: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.97|-0.41|0.4236
70983316|NCT00537940|141475722|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.29||0.5492|TWO_SIDED|95.0|-0.75|0.4|||Ranked ANCOVA|||Change at Week 21/ET, HADS-D: ANCOVA model was used to calculate LS mean estimates of the treatment1difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.40|-0.75|0.5492
70983317|NCT00537940|141475723|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|3.25|STANDARD_ERROR_OF_MEAN|2.07||0.116|TWO_SIDED|95.0|-0.81|7.31|||ANCOVA|||Baseline Sleep disturbance: ANCOVA model was used to calculate least square (LS) mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||7.31|-0.81|0.1160
70983318|NCT00537940|141475723|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|1.68||0.849|TWO_SIDED|95.0|-3.62|2.98|||ANCOVA|||Week 21 Sleep disturbance: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||2.98|-3.62|0.8490
70983319|NCT00537940|141475723|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|1.19|STANDARD_ERROR_OF_MEAN|2.82||0.6728|TWO_SIDED|95.0|-4.34|6.73|||ANCOVA|||Baseline snoring: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||6.73|-4.34|0.6728
71097368|NCT02014103|141703710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Sandoz Ratio X 100|101.92|||||TWO_SIDED|90.0|94.27|110.19|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||110.19|94.27|
70983320|NCT00537940|141475723|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|1.96|STANDARD_ERROR_OF_MEAN|2.3||0.3954|TWO_SIDED|95.0|-2.56|6.47|||ANCOVA|||Week 21 snoring: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||6.47|-2.56|0.3954
70983321|NCT00537940|141475723|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|4.03|STANDARD_ERROR_OF_MEAN|2.52||0.1106|TWO_SIDED|95.0|-0.92|8.98|||ANCOVA|||Baseline Awaken Short of Breath: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||8.98|-0.92|0.1106
70983322|NCT00537940|141475723|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|2.11||0.3603|TWO_SIDED|95.0|-6.09|2.22|||ANCOVA|||Week 21 Awaken Short of Breath: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||2.22|-6.09|0.3603
70983323|NCT00537940|141475723|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8312|TWO_SIDED|95.0|-0.3|0.24|||ANCOVA|||Baseline Quantity of Sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||0.24|-0.30|0.8312
70983324|NCT00537940|141475723|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.2||0.9101|TWO_SIDED|95.0|-0.38|0.42|||ANCOVA|||Week 21 Quantity of Sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||0.42|-0.38|0.9101
70983325|NCT00537940|141475723|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|-2.37|STANDARD_ERROR_OF_MEAN|2.45||0.3346|TWO_SIDED|95.0|-7.19|2.45|||ANCOVA|||Baseline Adequacy of Sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||2.45|-7.19|0.3346
70983326|NCT00537940|141475723|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|2.05||0.7491|TWO_SIDED|95.0|-4.69|3.37|||ANCOVA|||Week 21 Adequacy of Sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||3.37|-4.69|0.7491
70983327|NCT00537940|141475723|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|2.98|STANDARD_ERROR_OF_MEAN|1.9||0.1162|TWO_SIDED|95.0|-0.74|6.71|||ANCOVA|||Baseline Somnolence: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||6.71|-0.74|0.1162
70983328|NCT00537940|141475723|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|2.06|STANDARD_ERROR_OF_MEAN|1.66||0.2163|TWO_SIDED|95.0|-1.21|5.32|||ANCOVA|||Week 21 Somnolence: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||5.32|-1.21|0.2163
70983329|NCT00537940|141475723|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|3.45|STANDARD_ERROR_OF_MEAN|1.61||0.0321|TWO_SIDED|95.0|0.3|6.61|||ANCOVA|||Baseline Sleep Problem Index (9): ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||6.61|0.30|0.0321
70983330|NCT00537940|141475723|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|1.28||0.7889|TWO_SIDED|95.0|-2.17|2.85|||ANCOVA|||Week 21 Sleep Problem Index (9): ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||2.85|-2.17|0.7889
70983331|NCT00537940|141475724|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.653||||0.0252|TWO_SIDED|95.0|0.449|0.948|||Regression, Logistic|||Baseline: Logistic regression model was used to estimate odds ratio and corresponding 95% CI of treatment difference, with treatment as fixed effect and for post-baseline assessments baseline was included as a covariate.||0.948|0.449|0.0252
70983332|NCT00537940|141475724|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.811||||0.3459|TWO_SIDED|95.0|0.524|1.254|||Regression, Logistic|||Week 21: Logistic regression model was used to estimate odds ratio and corresponding 95% CI of treatment difference, with treatment as fixed effect and for post-baseline assessments baseline was included as a covariate.||1.254|0.524|0.3459
70983333|NCT00320671|141475754|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence Analysis|Cumulative Response Rates|56.8||||0.61|TWO_SIDED|95.0|43.9|69.9|||Log Rank||Only the subjects taking risperidone were analysed in this section|||69.9|43.9|.61
70983334|NCT00320671|141475754|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence Analysis|Cumulative Response Rates|62.8||||0.61|TWO_SIDED|95.0|50.8|74.8|||Log Rank||Only subjects taking aripiprazole were analysed in this section|||74.8|50.8|.61
70983335|NCT03334214|141475770|SUPERIORITY|||||||0.003|||||||ANOVA|||||||0.003
70983336|NCT03334214|141475771|SUPERIORITY|||||||0.026|||||||ANOVA|||||||0.026
70983337|NCT03334214|141475774|SUPERIORITY|||||||0.024|||||||ANOVA|||||||0.024
70983338|NCT03334214|141475775|SUPERIORITY|||||||0.0774|||||||Cochran-Mantel-Haenszel|The p-value is obtained using Cochran-Mantel-Haenszel (CMH) test stratified by the baseline liver fat stratum (\<20%, ≥20%) stratification factor.||||||0.0774
70983339|NCT03334214|141475776|SUPERIORITY|||||||0.183|||||||ANOVA|||||||0.183
70983340|NCT03334214|141475777|SUPERIORITY|||||||0.682|||||||ANOVA|||Total Cholesterol||||0.682
70983341|NCT03334214|141475777|SUPERIORITY|||||||0.716|||||||ANOVA|||ApoB||||0.716
70983342|NCT03334214|141475777|SUPERIORITY|||||||0.717|||||||ANOVA|||HDL||||0.717
70983343|NCT03334214|141475777|SUPERIORITY|||||||0.463|||||||ANOVA|||LDL-C||||0.463
70983344|NCT03334214|141475777|SUPERIORITY|||||||0.555|||||||ANOVA|||Non-HDL||||0.555
70983345|NCT03334214|141475777|SUPERIORITY|||||||0.619|||||||ANOVA|||Triglycerides||||0.619
71097369|NCT02014103|141703710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Astellas Ratio X 100|109.75|||||TWO_SIDED|90.0|100.42|119.25|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||119.25|100.42|
70983346|NCT03334214|141475777|SUPERIORITY|||||||0.698|||||||ANOVA|||VLDL-C||||0.698
71097370|NCT02014103|141703710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Astellas Ratio X 100|99.76|||||TWO_SIDED|90.0|91.28|109.03|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||109.03|91.28|
71097371|NCT02014103|141703710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Astellas Ratio X 100|101.63|||||TWO_SIDED|90.0|92.99|111.06|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||111.06|92.99|
71097372|NCT02014103|141703710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Astellas Ratio X 100|106.2|||||TWO_SIDED|90.0|97.17|116.06|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||116.06|97.17|
71097373|NCT02014103|141703710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Sandoz/Astellas Ratio X 100|104.09|||||TWO_SIDED|90.0|95.25|113.75|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||113.75|95.25|
71097374|NCT02014103|141703710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Dr Reddy Ratio X 100|110.02|||||TWO_SIDED|90.0|100.66|120.24|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||120.24|100.66|
70983347|NCT03334214|141475778|SUPERIORITY|||||||0.902|||||||ANOVA|||FPG||||0.902
70983348|NCT03334214|141475778|SUPERIORITY|||||||0.267|||||||Van Elteren test|||HOMA-IR||||0.267
70983349|NCT03334214|141475778|SUPERIORITY|||||||0.2|||||||Van Elteren test|||Insulin||||0.200
70983350|NCT03334214|141475779|SUPERIORITY|||||||0.933|||||||ANOVA|||||||0.933
70983351|NCT00995371|141475792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.52|||<|0.05|TWO_SIDED|95.0|1.09|3.96|||t-test, 2 sided|||The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||3.96|1.09|<0.05
70983352|NCT00995371|141475792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|||>|0.05|TWO_SIDED|95.0|-1.43|1.55|||t-test, 2 sided|||The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||1.55|-1.43|>0.05
70983353|NCT00995371|141475793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.33|||<|0.05|TWO_SIDED|95.0|3.35|19.31|||t-test, 2 sided|||The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||19.31|3.35|<0.05
70983354|NCT00995371|141475793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.65|||>|0.05||95.0|-4.12|15.41|||t-test, 2 sided|||The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||15.41|-4.12|>0.05
70983355|NCT00995371|141475794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.19|||<|0.05||95.0|0.61|3.77|||t-test, 2 sided|||The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||3.77|0.61|<0.05
70983356|NCT00995371|141475794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|||>|0.05||95.0|-0.66|2.66|||t-test, 2 sided|||The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||2.66|-0.66|>0.05
70983357|NCT00995371|141475795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.13|||<|0.05||95.0|7.43|24.83|||t-test, 2 sided|||The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||24.83|7.43|<0.05
70983358|NCT00995371|141475795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.17|||>|0.05||95.0|-1.24|13.58|||t-test, 2 sided|||The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||13.58|-1.24|>0.05
71097375|NCT02014103|141703710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Mylan Ratio X 100|108.0|||||TWO_SIDED|90.0|98.82|118.02|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||118.02|98.82|
71097376|NCT02014103|141703710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Panacea Ratio X 100|103.34|||||TWO_SIDED|90.0|94.56|112.94|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||112.94|94.56|
71097377|NCT02014103|141703710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Sandoz Ratio X 100|105.44|||||TWO_SIDED|90.0|96.48|115.23|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||115.23|96.48|
71097378|NCT02014103|141703710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Mylan Ration X 100|98.16|||||TWO_SIDED|90.0|89.82|107.28|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||107.28|89.82|
71097379|NCT02014103|141703710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr. Reddys/Panacea Ratio X 100|93.93|||||TWO_SIDED|90.0|85.96|102.65|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||102.65|85.96|
71097380|NCT02014103|141703710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Sandoz Ratio X 100|95.84|||||TWO_SIDED|90.0|87.69|104.74|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||104.74|87.69|
70983359|NCT00144300|141475811|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07||||||95.0|0.71|1.6||||||||1.60|0.71|
70983360|NCT03414359|141475851|NON_INFERIORITY|As there is no existing data in the literature that clearly defines a clinically significant reduction in the onset time of anesthesia, the non-inferiority margin was defined a priori based on clinical reasoning.||||||0.1||||||The a priori threshold for statistical significance is, \<0.05|Wilcoxon (Mann-Whitney)|||To exclude a clinically important difference between the LEBF group and the chloroprocaine group, given a standard deviation of 4 minutes, and a non-inferiority margin of 3 minutes difference between groups, 62 mother-infant dyads (31 mother-infant dyads in each arm) are required to have a significance level of 5% and a power of 90%. In total, 70 female patients were recruited to account for any withdrawals.||||0.10
70983361|NCT02273973|141475853|SUPERIORITY||Difference in Response Rates|10.71||||0.049|TWO_SIDED|95.0|0.11|21.32|||Cochran-Mantel-Haenszel|||||21.32|0.11|0.0490
70983362|NCT02273973|141475854|SUPERIORITY||Difference in Response Rates|1.21||||0.3698|TWO_SIDED|95.0|-1.12|3.55|||Fisher Exact|||||3.55|-1.12|0.3698
70983363|NCT02273973|141475855|SUPERIORITY||Difference in Response Rates|18.19||||0.0332|TWO_SIDED|95.0|2.57|33.81|||Cochran-Mantel-Haenszel|||||33.81|2.57|0.0332
70983364|NCT02273973|141475856|SUPERIORITY||Difference in Response Rates|1.37||||0.4803|TWO_SIDED|95.0|-1.3|4.04|||Fisher Exact|||||4.04|-1.30|0.4803
70983365|NCT02273973|141475857|SUPERIORITY||Difference in Response Rates|5.2||||0.5017|TWO_SIDED|95.0|-9.2|19.61|||Cochran-Mantel-Haenszel|||||19.61|-9.20|0.5017
70983366|NCT02273973|141475858|SUPERIORITY||Difference in Response Rates|1.05||||1|TWO_SIDED|95.0|-2.65|4.75|||Fisher Exact|||||4.75|-2.65|1.0000
71097381|NCT02014103|141703710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Panacea Ratio X 100|95.69|||||TWO_SIDED|90.0|87.56|104.58|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||104.58|87.56|
70983367|NCT02273973|141475859|SUPERIORITY||Difference in Response Rates|21.14||||0.0115|TWO_SIDED|95.0|5.59|36.68|||Cochran-Mantel-Haenszel|||||36.68|5.59|0.0115
70983368|NCT02273973|141475860|SUPERIORITY||Difference in Response Rates|2.66||||0.7928|TWO_SIDED|95.0|-11.88|17.2|||Cochran-Mantel-Haenszel|||||17.20|-11.88|0.7928
70983369|NCT02273973|141475861|SUPERIORITY||Difference in Response Rates|9.45||||0.2659|TWO_SIDED|95.0|-5.8|24.7|||Cochran-Mantel-Haenszel|||||24.70|-5.80|0.2659
70983370|NCT02273973|141475862|SUPERIORITY||Difference in Response Rates|7.63||||0.3299|TWO_SIDED|95.0|-6.34|21.6|||Cochran-Mantel-Haenszel|||||21.60|-6.34|0.3299
70983371|NCT02273973|141475863|SUPERIORITY||Difference in Response Rates|10.68||||0.1554|TWO_SIDED|95.0|-3.96|25.32|||Cochran-Mantel-Haenszel|||||25.32|-3.96|0.1554
70983372|NCT02273973|141475864|SUPERIORITY||Difference in Response Rates|2.41||||0.787|TWO_SIDED|95.0|-11.82|16.63|||Cochran-Mantel-Haenszel|||||16.63|-11.82|0.7870
70983373|NCT02273973|141475865|SUPERIORITY||Ratio of Least square mean|0.83||||0.117|TWO_SIDED|95.0|0.65|1.05|||Regression, Linear|||Statistical analysis for changes in Ki67 levels from Baseline to Week 3.||1.05|0.65|0.117
70983374|NCT02273973|141475865|SUPERIORITY||Ratio of Least square mean|1.25||||0.105|TWO_SIDED|95.0|0.95|1.65|||Regression, Linear|||Statistical analysis for changes in Ki67 levels from Baseline to Surgery.||1.65|0.95|0.105
70983375|NCT02273973|141475867|SUPERIORITY||Least squares mean difference|-13.32||||0.002|TWO_SIDED|95.0|-21.67|-4.96|||Regression, Linear|||||-4.96|-21.67|0.002
70983376|NCT02680301|141475916|EQUIVALENCE|Wilcoxon sign- rank test values with ranks from change in cream efficacy ratings minus change in ointment efficacy ratings.||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
70983377|NCT00095121|141475919|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||End of double-blind treatment|Fisher Exact|||After unblinding the results, due to the small number of responders in the placebo group, it was determined that a statistical exact test would be more appropriate in the evaluation of treatment group differences than the originally planned 95% confidence intervals of the difference between the groups. Therefore, the results were analyzed by study visit, and a Fisher exact test was used to evaluate treatment differences between the adefovir dipivoxil and placebo groups.||||<0.001
70983378|NCT00095121|141475935|SUPERIORITY_OR_OTHER|||||||0.051||||||Comparison of HBeAg Loss|Fisher Exact|||||||0.051
70983379|NCT00095121|141475935|SUPERIORITY_OR_OTHER|||||||0.051||||||Comparison of HBeAg Seroconversion|Fisher Exact|||||||0.051
70983380|NCT02209597|141475941|SUPERIORITY||||||<|0.05|ONE_SIDED|90.0|||||ANOVA|||||||<0.05
71097382|NCT02014103|141703710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Sandoz Ratio X 100|97.63|||||TWO_SIDED|90.0|89.34|107.71|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||107.71|89.34|
71097383|NCT02014103|141703710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Pancea/Sandoz Ratio X 100|102.03|||||TWO_SIDED|90.0|93.36|111.51|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||111.51|93.36|
70983381|NCT03551522|141475957|OTHER|The LS Means, confidence intervals, and p-values come from an ANCOVA model with relative (percent) change from baseline as the dependent variable and treatment and stratification groups (diabetic status and fibrosis stage) as factors and baseline as a covariate.|LS Mean of Difference|11.02||||0.0874|TWO_SIDED|95.0|-1.63|23.67|||ANCOVA|||||23.67|-1.63|0.0874
71097384|NCT02014103|141703711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Astellas Ratio X 100|141.91|||||TWO_SIDED|90.0|125.73|160.16|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||160.16|125.73|
71097385|NCT02014103|141703711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Astellas Ratio X 100|104.13|||||TWO_SIDED|90.0|92.33|117.45|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||117.45|92.33|
71097386|NCT02014103|141703711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Astellas Ratio X 100|116.02|||||TWO_SIDED|90.0|102.87|130.87|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||130.87|102.87|
71097387|NCT02014103|141703711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Astellas Ratio X 100|108.92|||||TWO_SIDED|90.0|96.51|122.94|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||122.94|96.51|
71097388|NCT02014103|141703711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Sandoz/Astellas Ratio X 100|94.06|||||TWO_SIDED|90.0|83.33|106.16|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||106.16|83.33|
71097389|NCT02014103|141703711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Dr. Reddys Ratio X 100|136.27|||||TWO_SIDED|90.0|120.82|153.7|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||153.70|120.82|
71097390|NCT02014103|141703711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Mylan Ratio X 100|122.31|||||TWO_SIDED|90.0|108.37|138.04|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||138.04|108.37|
71097391|NCT02014103|141703711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Panacea Ratio X 100|130.28|||||TWO_SIDED|90.0|115.43|147.04|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||147.04|115.43|
70983382|NCT03551522|141475957|OTHER|The LS Means, confidence intervals, and p-values come from an ANCOVA model with relative (percent) change from baseline as the dependent variable and treatment and stratification groups (diabetic status and fibrosis stage) as factors and baseline as a covariate.|LS Mean of Difference|6.54||||0.3151|TWO_SIDED|95.0|-6.28|19.37|||ANCOVA|||||19.37|-6.28|0.3151
70983383|NCT03551522|141475957|OTHER|The LS Means, confidence intervals, and p-values come from an ANCOVA model with relative (percent) change from baseline as the dependent variable and treatment and stratification groups (diabetic status and fibrosis stage) as factors and baseline as a covariate.|LS Mean of Difference|7.78||||0.2313|TWO_SIDED|95.0|-5.01|20.58|||ANCOVA|||||20.58|-5.01|0.2313
71097392|NCT02014103|141703711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Sandoz Ratio X 100|150.88|||||TWO_SIDED|90.0|133.77|170.18|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||170.18|133.77|
71097393|NCT02014103|141703711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr. Reddys/Mylan Ratio X 100|89.75|||||TWO_SIDED|90.0|79.52|101.3|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||101.30|79.52|
71097394|NCT02014103|141703711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Panacea Ratio X 100|95.6|||||TWO_SIDED|90.0|84.71|107.9|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||107.90|84.71|
71097395|NCT02014103|141703711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Sandoz Ratio X 100|110.72|||||TWO_SIDED|90.0|98.1|124.96|||||Bioequivalence is established when 90% confidence interval falls within 80-125|||124.96|98.10|
71097396|NCT02014103|141703711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Panacea Ratio X 100|106.52|||||TWO_SIDED|90.0|94.44|120.15|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||120.15|94.44|
71097397|NCT02014103|141703711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Sandoz Ratio X 100|123.36|||||TWO_SIDED|90.0|109.3|139.23|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||139.23|109.30|
71097398|NCT02014103|141703711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Sandoz Ratio X 100|115.81|||||TWO_SIDED|90.0|102.68|130.62|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||130.62|102.68|
70983384|NCT01225068|141475981|SUPERIORITY_OR_OTHER||effect size|0.22||||||||||no p value for effect size calculations ES is dimensionless; ES (Cohen's d) is a well described statistical construct and is calculated from the difference between the means (here at baseline and 6 weeks) divided by the pooled standard deviation.|effect size is endpoint and not comparis|no p value for effect size calculations||effect size is endpoint and not comparison||||
70983385|NCT02858193|141475991|EQUIVALENCE|Acceptance criterion for bioequivalence was that 94.12% confidence intervals (CIs) of the T/R ratios of the geometric means of the analysed PK parameters were within the 80.00-125.00% range according to the current guidelines for bioequivalence studies.|Geometric means ratio|111.63||||0.0482|TWO_SIDED|94.12|100.51|123.99||"treatment p-value reported"|ANOVA||Estimated value and limits are expressed in %|||123.99|100.51|0.0482
70983386|NCT02858193|141475993|EQUIVALENCE|Acceptance criterion for bioequivalence was that 94.12% confidence intervals (CIs) of the T/R ratios of the geometric means of the analysed PK parameters were within the 80.00-125.00% range according to the current guidelines for bioequivalence studies|geometric means ratio|109.41||||0.0002|TWO_SIDED|94.12|104.93|114.07||"treatment p-value is reported"|ANOVA||Estimated value and limits are expressed in%|||114.07|104.93|0.0002
70983387|NCT02858193|141475994|EQUIVALENCE|Acceptance criterion for bioequivalence was that 94.12% confidence intervals (CIs) of the T/R ratios of the geometric means of the analysed PK parameters were within the 80.00-125.00% range according to the current guidelines for bioequivalence studies.||||||0.593|||||||Friedman|||||||0.5930
70983388|NCT04426630|141476001|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.||||<0.001
70983389|NCT04426630|141476002|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||<0.001
70983390|NCT04426630|141476003|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||<0.001
70983391|NCT04426630|141476004|SUPERIORITY|||||||0.028|||||||Chi-squared|Wilcoxon sign-rank test used to compared baseline outcomes to 6 month outcomes.||Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.||||0.028
70983392|NCT04426630|141476005|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
70983393|NCT04426630|141476006|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
70983394|NCT04426630|141476007|SUPERIORITY|||||||0.23|||||||Chi-squared|||||||0.23
70983395|NCT04426630|141476008|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
70983396|NCT04426630|141476009|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||<0.001
70983397|NCT04426630|141476010|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||<0.001
70983398|NCT04426630|141476011|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||0.07
70983399|NCT04426630|141476012|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
70983400|NCT01466751|141476013|SUPERIORITY_OR_OTHER||Type III Tests of Fixed Effects|8.687||||0.004|TWO_SIDED|||||A-priori threshold for statistical significance: p \< 0.05. No correction for multiple comparisons. The omnibus effect from the linear mixed model for the Treatment Arm x Time Interaction was utilized to establish significance of the effect.|Mixed Models Analysis|Numerator degrees of freedom=1, Denominator degrees of freedom = 168||A linear mixed model was utilized to test the null hypothesis that the intervention groups would show equivalent performance change on the outcome measure from baseline to the 3 month time points.||||0.004
70983401|NCT01466751|141476014|SUPERIORITY_OR_OTHER||Type III Tests of Fixed Effects|2.032||||0.156|TWO_SIDED|||||No adjustment for multiple comparisons. The a priori threshold was: p \< 0.05.|Mixed Models Analysis|Numerator degrees of freedom: 1, Denominator degrees of freedom: 168||A linear mixed model was used to test the null hypothesis that the two treatment groups would display no differential changes in amygdala BOLD signal from baseline to 3 months as a main effect or in interaction with facial affect type (fear or happy) or by brain hemisphere (left or right).||||0.156
70983402|NCT00849693|141476037|SUPERIORITY_OR_OTHER|||||||0.193||95.0|||||Mixed Models Analysis|||||||0.193
70983403|NCT01062399|141476050|OTHER||||||||||||||||||A dose level for RAD001 will be considered acceptable if no patient of the first 3patients or no more than 2 patients of the first 6 patients experience a DLT. If the current level is considered acceptable, then dose escalation will occur and the protocol will be reopened. Otherwise, the preceding acceptable dose level will be declared the MTD.|||
70983404|NCT01062399|141476051|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.79|TWO_SIDED|95.0|0.82|1.6|||Log Rank||Reference arm = RT + TMZ|Assuming exponential distribution with median PFS (mPFS) time for control of 6.7 mos. for the control arm, tt was hypothesized that there would be a 43% improvement in mPFS time, corresponding to a mPFS time of 9.6. This is equivalent to a hazard ratio of 0.7 for the experimental arm vs. control arm. With a 1-sided significance level = 0.15 and 85% power, a total of 134 PFS events out of 180 eligible patients were required to detect the projected effect size.||1.60|0.82|0.79
70983405|NCT01062399|141476052|SUPERIORITY||Hazard Ratio (HR)|1.67||||0.008|TWO_SIDED|95.0|1.14|2.45|||Log Rank|2-sided significance level = 0.05|Reference level = RT + TMZ|||2.45|1.14|0.008
70983406|NCT00984659|141476083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.713|TWO_SIDED|95.0|-0.03|0.05|||t-test, 2 sided|||||0.05|-0.03|0.713
70983407|NCT00984659|141476087|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Analysis of covariance (ANCOVA) adjusted for age, gender, and percent predicted Forced Expiratory volume in one second (FEV1) at Screening.|ANCOVA|||||||<0.001
70983408|NCT00984659|141476088|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||ANCOVA adjusted for age, gender, and percent predicted FEV1 at Screening.|ANCOVA|||||||<0.001
70983409|NCT00984659|141476089|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||ANCOVA adjusted for age, gender, and percent predicted FEV1 at Screening|ANCOVA|||||||0.008
70983410|NCT00984659|141476091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|||<|0.001||95.0|0.18|0.31||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 8|ANCOVA|||||0.31|0.18|<0.001
71097399|NCT02014103|141703711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Astellas Ratio X 100|112.96|||||TWO_SIDED|90.0|100.32|127.2|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||127.20|100.32|
71097400|NCT02014103|141703711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Astellas Ratio X 100|101.75|||||TWO_SIDED|90.0|90.37|114.57|||||Bioequivalence is established when 90% confidence interval falls within 80-125|||114.57|90.37|
71097401|NCT02014103|141703711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Astella Ratio X 100|113.52|||||TWO_SIDED|90.0|100.82|127.83|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||127.83|100.82|
71097402|NCT02014103|141703711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Astellas Ratio X 100|99.16|||||TWO_SIDED|90.0|88.06|111.64|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||111.64|88.06|
71097403|NCT02014103|141703711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Sandoz/Astellas Ratio X 100|95.57|||||TWO_SIDED|90.0|84.89|107.61|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||107.61|84.89|
70983411|NCT00984659|141476091|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.12|||<|0.001||95.0|0.06|0.19||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 15|ANCOVA|||||0.19|0.06|<0.001
70983412|NCT00984659|141476091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|||<|0.001||95.0|0.06|0.16||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 22|ANCOVA|||||0.16|0.06|<0.001
70983413|NCT00984659|141476091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|||<|0.001||95.0|0.06|0.17||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 29|ANCOVA|||||0.17|0.06|<0.001
70983414|NCT00984659|141476091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|||<|0.001||95.0|0.08|0.18||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 36|ANCOVA|||||0.18|0.08|<0.001
70983415|NCT00984659|141476091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.18||95.0|-0.03|0.15||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 43|ANCOVA|||||0.15|-0.03|0.180
70983416|NCT00984659|141476091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.307||95.0|-0.07|0.23||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Visit 3/PD|ANCOVA|||||0.23|-0.07|0.307
70983417|NCT00984659|141476095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|||<|0.001||95.0|0.14|0.34||ANCOVA adjusted for age, gender, and SOBDA Baseline score; comparision of mean SOBDA score for CGI-C responders and non-responders|ANCOVA|||||0.34|0.14|<0.001
70983418|NCT00984659|141476096|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.3|||<|0.001|TWO_SIDED|95.0|0.21|0.4||ANCOVA adjusted for age, gender, and SOBDA Baseline score; comparision of mean SOBDA score for CRQ-SAS Dyspnea Domain responders and non-responders|ANCOVA|||||0.40|0.21|<0.001
70983419|NCT00984659|141476097|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.03||||0.535||95.0|-0.08|0.15||ANCOVA adjusted for age, gender, and SOBDA Baseline score; comparision of mean SOBDA score for Physician-Completed mMRC responders and non-responders|ANCOVA|||||0.15|-0.08|0.535
70983420|NCT00984659|141476097|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.08||||0.08||95.0|-0.02|0.19||ANCOVA adjusted for age, gender, and SOBDA Baseline score; comparison of mean SOBDA score for Participant-Completed mMRC responders and non-responders|ANCOVA|||||0.19|-0.02|0.08
70983421|NCT02951273|141476102|SUPERIORITY|||||||0.0276|||||||repeated measure mixed model|||||||0.0276
70983422|NCT02951273|141476103|SUPERIORITY||||||<|0.0001|||||||repeated measure mixed model|||||||<0.0001
71097404|NCT02014103|141703711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Dr Reddy Ratio X 100|111.01|||||TWO_SIDED|90.0|98.59|125.0|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||125.00|98.59|
71097405|NCT02014103|141703711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Mylan Ratio X 100|99.51|||||TWO_SIDED|90.0|88.38|112.04|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||112.04|88.38|
71097406|NCT02014103|141703711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Panacea Ratio X 100|113.93|||||TWO_SIDED|90.0|101.18|128.28|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||128.28|101.18|
71097407|NCT02014103|141703711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Sandoz Ratio X 100|118.19|||||TWO_SIDED|90.0|104.96|133.08|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||133.08|104.96|
71097408|NCT02014103|141703711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Mylan|89.64|||||TWO_SIDED|90.0|79.61|100.93|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||100.93|79.61|
71097409|NCT02014103|141703711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr. Reddys/Panacea Ratio X 100|102.63|||||TWO_SIDED|90.0|91.15|115.55|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||115.55|91.15|
70983423|NCT02951273|141476104|SUPERIORITY|||||||0.6025|||||||Regression, Linear|||||||0.6025
70983424|NCT02951273|141476105|SUPERIORITY|||||||0.3213|||||||repeated measure mixed model|||||||0.3213
70983425|NCT02951273|141476106|SUPERIORITY|||||||0.0005||||||The reported p-value was calculated|repeated measure mixed model|||||||0.0005
70983426|NCT02951273|141476107|SUPERIORITY|||||||0.5404|||||||repeated measure mixed model|||||||0.5404
70983427|NCT02951273|141476108|SUPERIORITY|||||||0.8947|||||||repeated measure mixed model|||||||0.8947
70983428|NCT02951273|141476109|SUPERIORITY|||||||0.0068|||||||Linear mixed models|||||||0.0068
70983429|NCT02951273|141476110|SUPERIORITY||||||<|0.0001|||||||repeated measure mixed model|||||||<0.0001
70983430|NCT02951273|141476111|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
70983431|NCT02951273|141476112|SUPERIORITY||||||<|0.0001|||||||repeated measure mixed model|||||||<0.0001
70983432|NCT02951273|141476113|SUPERIORITY||||||<|0.0001|||||||repeated measure mixed model|||||||<0.0001
70983433|NCT00121225|141476118|SUPERIORITY|||||||0.029|||||||Fisher Exact|||||||0.029
70983434|NCT02424149|141476206|SUPERIORITY_OR_OTHER|||||||0.77|||||||t-test, 2 sided|||||||0.77
70983435|NCT02424149|141476207|SUPERIORITY_OR_OTHER|||||||0.73|||||||t-test, 2 sided|||||||0.73
70983436|NCT02424149|141476208|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
70983437|NCT02424149|141476209|SUPERIORITY_OR_OTHER|||||||0.78|||||||t-test, 2 sided|||||||0.78
70983438|NCT02424149|141476210|SUPERIORITY_OR_OTHER|||||||0.04|||||||Fisher Exact|||||||0.04
70983439|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.32|0.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.46|0.32|
70983440|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.3|0.41|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.41|0.30|
70983441|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.44|0.61|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.61|0.44|
70983442|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.17|0.25|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.25|0.17|
70983443|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.18|0.24|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.24|0.18|
70983444|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.31|0.41|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.41|0.31|
70983445|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.19|0.32|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.32|0.19|
70983446|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.22|0.33|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.33|0.22|
70983447|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.17|0.3|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.30|0.17|
71097410|NCT02014103|141703711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr. Reddys/Sandoz Ratio X 100|106.46|||||TWO_SIDED|90.0|94.55|119.88|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||119.88|94.55|
71097411|NCT02014103|141703711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Panacea Ratio X 100|114.49|||||TWO_SIDED|90.0|110.68|128.92|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||128.92|110.68|
70983448|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.25|0.39|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.39|0.25|
70983449|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.27|0.38|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.38|0.27|
70983450|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.44|0.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.60|0.44|
70983451|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.1|||||TWO_SIDED|95.0|0.1|0.2|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.20|0.10|
70983452|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.17|0.25|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.25|0.17|
70983453|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.1|||||TWO_SIDED|95.0|0.09|0.16|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.16|0.09|
70983454|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.41|0.62|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.62|0.41|
70983455|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.43|0.62|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.62|0.43|
70983456|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.38|0.59|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.59|0.38|
70983457|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.6|1.0|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.00|0.60|
70983458|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.51|0.75|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.75|0.51|
70983459|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.86|1.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.46|0.86|
70983460|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.41|0.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.80|0.41|
70983461|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.39|0.73|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.73|0.39|
70983462|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.78|1.67|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.67|0.78|
70983463|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.71|1.08|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.08|0.71|
71097412|NCT02014103|141703711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Sandoz Ratio X 100|118.77|||||TWO_SIDED|90.0|105.48|133.74|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||133.74|105.48|
70983464|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.54|0.75|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.75|0.54|
70983465|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.78|1.06|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.06|0.78|
71097413|NCT02014103|141703711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Sandoz Ratio X 100|103.74|||||TWO_SIDED|90.0|92.13|116.81|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||116.81|92.13|
71097414|NCT04193176|141703724|SUPERIORITY||Mean Difference (Net)|-11.67||||0.004|TWO_SIDED|95.0|-19.67|-3.67|||ANCOVA|||||-3.67|-19.67|0.004
71097415|NCT02370394|141703734|SUPERIORITY||Mean Difference (Final Values)|-4.14||||0.4016|TWO_SIDED|95.0|-14.02|5.75|||t-test, 2 sided|Unequal variances handled by Satterthwaite's degrees of freedom||CAS Victimization Total Score at Follow Up||5.75|-14.02|0.4016
71097416|NCT02370394|141703734|SUPERIORITY||Mean Difference (Net)|14.46||||0.0072|TWO_SIDED|95.0|4.11|24.82|||t-test, 2 sided|||Change in CAS Victimization Total score from Baseline to Follow Up||24.82|4.11|0.0072
71097417|NCT02370394|141703735|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.6011|TWO_SIDED|95.0|-0.21|0.12|||t-test, 2 sided|||Safety Behavior Change Score at Follow Up||0.12|-0.21|0.6011
71097418|NCT02370394|141703735|SUPERIORITY||Mean Difference (Net)|-0.01||||0.9116|TWO_SIDED|95.0|-0.16|0.15|||t-test, 2 sided|||Change is Safety Behavior Change Score from Baseline to Follow Up||0.15|-0.16|0.9116
70983466|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.29|0.51|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.51|0.29|
70983467|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.39|0.56|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.56|0.39|
71097419|NCT02370394|141703736|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.8646|TWO_SIDED|95.0|-1.62|1.36|||t-test, 2 sided|Unequal variances handled by Satterthwaite's degrees of freedom||EOR Number of issues Effective at Accomplishing at Follow Up||1.36|-1.62|0.8646
71097420|NCT02370394|141703736|SUPERIORITY||Mean Difference (Net)|-0.86||||0.3045|TWO_SIDED|95.0|-2.54|0.82|||t-test, 2 sided|||Change in Number of Issues Effective at Accomplishing from Baseline to Follow Up||0.82|-2.54|0.3045
71097421|NCT02370394|141703737|SUPERIORITY|||||||0.9085|||||||Wilcoxon (Mann-Whitney)|||Motivation Scale at Follow Up||||0.9085
71097422|NCT02370394|141703737|SUPERIORITY|||||||0.3256|||||||Wilcoxon (Mann-Whitney)|||Change in Motivation Scale from Baseline to Follow Up||||0.3256
71097423|NCT02370394|141703738|SUPERIORITY|||||||0.4085|||||||Wilcoxon (Mann-Whitney)|||Readiness at Follow Up||||0.4085
71097424|NCT02370394|141703738|SUPERIORITY|||||||0.2467|||||||Wilcoxon (Mann-Whitney)|||Change in Readiness from Baseline to Follow Up||||0.2467
71097425|NCT01902303|141703742|SUPERIORITY_OR_OTHER||||||>|0.5|TWO_SIDED||||||Chi-squared|||||||>.5000
71097426|NCT01902303|141703743|SUPERIORITY_OR_OTHER|||||||0.3835|TWO_SIDED||||||Chi-squared|||||||.3835
71097427|NCT00908388|141703808|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||(1-Posterior probability of meeting performance goal given the data)|Bayesian adaptive|||||||.006
71097428|NCT01301001|141703826|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.07|TWO_SIDED|95.0|-0.7|0.0|||Mixed Models Analysis|||||0.0|-0.7|0.07
71097429|NCT01301001|141703827|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.76|TWO_SIDED|95.0|-0.9|0.6|||Mixed Models Analysis|||||0.6|-0.9|0.76
71097430|NCT01301001|141703828|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.36|TWO_SIDED|95.0|-0.5|0.2|||Mixed Models Analysis|||||0.2|-0.5|0.36
71097431|NCT00337194|141703858|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Chi-squared|||||||0.06
71097432|NCT00337194|141703859|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0
71097433|NCT01623752|141703868|OTHER|||||||0.278|||||||Paired t-test|||P-value was calculated using Paired t-test for the change in normalized progression.||||0.278
71097434|NCT01623752|141703868|OTHER|||||||0.222|||||||Paired t-test|||P-value was calculated using Paired t-test for the change in normalized progression.||||0.222
71097435|NCT01623752|141703869|OTHER|||||||0.251|||||||Paired t-test|||P-value was calculated using Paired t-test for the change in normalized progression.||||0.251
71097436|NCT01623752|141703869|OTHER|||||||0.218|||||||Paired t-test|||P-value was calculated using Paired t-test for the change in normalized progression.||||0.218
71097437|NCT01623752|141703872|OTHER|||||||0.675|||||||Regression, Linear|||||||0.675
71097438|NCT01623752|141703872|OTHER|||||||0.357|||||||Regression, Linear|||||||0.357
71097439|NCT01623752|141703873|OTHER|||||||0.106|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.106
70983468|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.53|0.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.69|0.53|
70983469|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.49|0.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.69|0.49|
70983470|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.52|0.63|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.63|0.52|
70983471|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.53|0.66|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.66|0.53|
70983472|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.42|0.64|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.64|0.42|
70983473|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.44|0.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.60|0.44|
70983474|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.63|0.88|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.88|0.63|
70983475|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.15|0.26|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.26|0.15|
70983476|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.23|0.35|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.35|0.23|
70983477|NCT01025336|141476212|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.28|0.43|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.43|0.28|
70983478|NCT01025336|141476213|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.42|0.56|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.56|0.42|
71097440|NCT01623752|141703873|OTHER|||||||0.181|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.181
71097441|NCT01623752|141703874|OTHER|||||||0.015|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.015
71097442|NCT01623752|141703874|OTHER|||||||0.969|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.969
71097443|NCT01623752|141703875|OTHER|||||||0.489|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.489
71097444|NCT01623752|141703875|OTHER|||||||0.386|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.386
71097445|NCT01623752|141703876|OTHER|||||||0.364|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.364
71097446|NCT01623752|141703876|OTHER|||||||0.849|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.849
71097447|NCT00165698|141703913|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Symbols rank sum test|||||||0.26
71097448|NCT00165698|141703914|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||Symbols rank sum test|||||||0.19
71097449|NCT00165698|141703915|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Symbols rank sum test|||||||0.31
71097450|NCT00165698|141703916|SUPERIORITY_OR_OTHER|||||||0.869||95.0|||||symbols rank sum test|||||||0.869
71097451|NCT00165698|141703917|SUPERIORITY_OR_OTHER|||||||0.174||95.0|||||symbols rank sum test|||||||0.174
71097452|NCT00165698|141703918|SUPERIORITY_OR_OTHER|||||||0||95.0|||||symbols rank sum test|||||||0.000
71097453|NCT00165698|141703919|SUPERIORITY_OR_OTHER|||||||0||95.0|||||symbols rank sum test|||||||0.000
71097454|NCT00165698|141703920|SUPERIORITY_OR_OTHER|||||||0||95.0|||||symbols rank sum test|||||||0.000
71097455|NCT01107457|141703924|SUPERIORITY_OR_OTHER_LEGACY|||||||0.079|TWO_SIDED||||||Fisher Exact|||||||0.079
71097456|NCT01107457|141703924|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
70983479|NCT01025336|141476213|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.56|0.72|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.72|0.56|
70983480|NCT01025336|141476213|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.35|0.45|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.45|0.35|
71097457|NCT01107457|141703924|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
71097458|NCT01107457|141703924|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
71097459|NCT01107457|141703925|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71097460|NCT01107457|141703925|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71097461|NCT01107457|141703925|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71097462|NCT01107457|141703925|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71097463|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|0.81|||||TWO_SIDED|95.0|0.61|1.07||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.07|0.61|
71097464|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC Ratio|1.15|||||TWO_SIDED|95.0|0.87|1.52||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.52|0.87|
71097465|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC Ratio|1.42|||||TWO_SIDED|95.0|1.03|1.96||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.96|1.03|
71097466|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|0.62|||||TWO_SIDED|95.0|0.46|0.84||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.84|0.46|
71097467|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|0.89|||||TWO_SIDED|95.0|0.66|1.2||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.20|0.66|
71097468|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|1.44|||||TWO_SIDED|95.0|1.02|2.04||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.04|1.02|
71097469|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|1.04|||||TWO_SIDED|95.0|0.82|1.32||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.32|0.82|
71097470|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|1.09|||||TWO_SIDED|95.0|0.86|1.39||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.39|0.86|
71097471|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|1.05|||||TWO_SIDED|95.0|0.79|1.39||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.39|0.79|
71097472|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|1.02|||||TWO_SIDED|95.0|0.77|1.34||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.34|0.77|
71097473|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|1.04|||||TWO_SIDED|95.0|0.79|1.37||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.37|0.79|
71097474|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|1.02|||||TWO_SIDED|95.0|0.74|1.4||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.40|0.74|
71097475|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|0.75|||||TWO_SIDED|95.0|0.57|0.97||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.97|0.57|
71097476|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|0.85|||||TWO_SIDED|95.0|0.65|1.11||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.11|0.65|
71097477|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMCratio|1.14|||||TWO_SIDED|95.0|0.84|1.56||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.56|0.84|
71097478|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|1.37|||||TWO_SIDED|95.0|0.97|1.94||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.94|0.97|
70983481|NCT01025336|141476213|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.44|0.57|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.57|0.44|
71036769|NCT00205777|141581650|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.573||||0.014|TWO_SIDED|95.0|0.367|0.896|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40/20 mg \[SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||0.896|0.367|0.014
71036770|NCT00205777|141581650|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.157||||0.5|TWO_SIDED|95.0|0.71|1.885|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40/20 mg \[SE I\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.885|0.710|0.50
71036771|NCT00205777|141581651|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.085|TWO_SIDED|95.0|0.44|1.052|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[SE II\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.052|0.440|0.085
71036772|NCT00205777|141581651|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.004|TWO_SIDED|95.0|0.434|0.857|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[SE II\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||0.857|0.434|0.004
71036773|NCT00205777|141581652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.621||||0.4|TWO_SIDED|95.0|0.203|1.903|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.||1.903|0.203|0.40
71036774|NCT00205777|141581652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.504||||0.26|TWO_SIDED|95.0|0.151|1.676|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.||1.676|0.151|0.26
71097479|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|1.1|||||TWO_SIDED|95.0|0.78|1.55||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.55|0.78|
71097480|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|0.8|||||TWO_SIDED|95.0|0.54|1.19||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.19|0.54|
71097481|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|0.8|||||TWO_SIDED|95.0|0.61|1.05||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.05|0.61|
71097482|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|0.95|||||TWO_SIDED|95.0|0.73|1.25||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.25|0.73|
71097483|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|1.19|||||TWO_SIDED|95.0|0.87|1.64||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.64|0.87|
71097484|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|3.62|||||TWO_SIDED|95.0|2.76|4.74||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.74|2.76|
71097485|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|0.52|||||TWO_SIDED|95.0|0.4|0.68||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.68|0.40|
71097486|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|0.14|||||TWO_SIDED|95.0|0.1|0.2||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.20|0.10|
71097487|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|1.13|||||TWO_SIDED|95.0|0.8|1.59||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.59|0.80|
71097488|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|0.87|||||TWO_SIDED|95.0|0.62|1.23||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.23|0.62|
71036775|NCT00205777|141581652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.54||||0.33|TWO_SIDED|95.0|0.157|1.86|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.||1.860|0.157|0.33
71036776|NCT00205777|141581652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.661||||0.49|TWO_SIDED|95.0|0.206|2.118|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.||2.118|0.206|0.49
71036777|NCT00205777|141581652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.76|TWO_SIDED|95.0|0.305|2.37|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.||2.370|0.305|0.76
71097489|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|0.77|||||TWO_SIDED|95.0|0.52|1.15||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.15|0.52|
71097490|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|3.49|||||TWO_SIDED|95.0|2.68|4.54||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.54|2.68|
70983482|NCT01025336|141476213|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.6|0.85|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.85|0.60|
70983483|NCT01025336|141476213|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.63|0.97|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.97|0.63|
70983484|NCT01025336|141476213|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.81|1.08|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.08|0.81|
70983485|NCT01025336|141476213|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.74|0.99|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.99|0.74|
70983486|NCT01025336|141476213|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.19|0.29|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.29|0.19|
70983487|NCT01025336|141476213|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.19|0.29|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations|Serotype 6A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.29|0.19|
70983488|NCT01025336|141476213|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.31|0.45|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.45|0.31|
70983489|NCT01025336|141476213|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.4|0.59|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.59|0.40|
70983490|NCT01025336|141476213|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.58|0.96|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations|Serotype 7F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.96|0.58|
70983491|NCT01025336|141476213|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.67|1.13|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.13|0.67|
70983492|NCT01025336|141476213|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.37|0.67|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.67|0.37|
70983493|NCT01025336|141476213|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.57|1.12|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.12|0.57|
70983494|NCT01025336|141476213|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.85|1.09|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.09|0.85|
70983495|NCT01025336|141476213|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.04|1.43|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.43|1.04|
70983496|NCT01025336|141476213|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.48|0.62|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.62|0.48|
70983497|NCT01025336|141476213|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.59|0.83|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.83|0.59|
70983498|NCT01025336|141476213|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.57|0.72|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.72|0.57|
70983499|NCT01025336|141476213|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.65|0.79|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.79|0.65|
71097491|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|0.52|||||TWO_SIDED|95.0|0.4|0.68||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.68|0.40|
71097492|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|0.15|||||TWO_SIDED|95.0|0.11|0.2||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.20|0.11|
71097493|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|1.61|||||TWO_SIDED|95.0|1.15|2.23||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.23|1.15|
71097494|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|1.24|||||TWO_SIDED|95.0|0.89|1.72||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.72|0.89|
71097495|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|0.77|||||TWO_SIDED|95.0|0.53|1.13||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.13|0.53|
70983500|NCT01025336|141476213|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.66|0.93|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.93|0.66|
70983501|NCT01025336|141476213|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.75|1.05|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.05|0.75|
70983502|NCT01025336|141476213|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.27|0.37|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations|Serotype 23F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.37|0.27|
70983503|NCT01025336|141476213|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.34|0.48|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.48|0.34|
70983504|NCT01025336|141476214|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.85|1.22|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.22|0.85|
70983505|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.79|1.02|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.02|0.79|
70983506|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.69|0.9|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.90|0.69|
70983507|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.82|1.1|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.10|0.82|
70983508|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.98|1.32|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.32|0.98|
71097496|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|1.63|||||TWO_SIDED|95.0|1.28|2.08||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.08|1.28|
70983509|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.62|0.81|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.81|0.62|
70983510|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.41|0.69|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.69|0.41|
70983511|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.6|0.82|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.82|0.60|
70983512|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.47|0.76|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.76|0.47|
70983513|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.67|0.87|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.87|0.67|
71036778|NCT00205777|141581652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.238||||0.75|TWO_SIDED|95.0|0.332|4.616|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.||4.616|0.332|0.75
71036779|NCT00205777|141581653|SUPERIORITY_OR_OTHER||Relative Risk|0.9|||||TWO_SIDED|95.0|0.38|2.15||||||Relative risk versus placebo was provided together with 95% CIs.||2.15|0.38|
71097497|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|1.03|||||TWO_SIDED|95.0|0.81|1.3||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.30|0.81|
71097498|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|0.63|||||TWO_SIDED|95.0|0.47|0.83||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.83|0.47|
71097499|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|1.99|||||TWO_SIDED|95.0|1.51|2.63||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.63|1.51|
71097500|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|1.04|||||TWO_SIDED|95.0|0.79|1.37||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.37|0.79|
70983514|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.96|1.3|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.30|0.96|
71097501|NCT01026038|141703956|SUPERIORITY_OR_OTHER||GMC ratio|0.52|||||TWO_SIDED|95.0|0.38|0.72||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.72|0.38|
70983515|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.75|1.02|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.02|0.75|
70983516|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.48|0.79|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.79|0.48|
70983517|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.32|0.46|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.46|0.32|
71036780|NCT00205777|141581653|SUPERIORITY_OR_OTHER||Relative Risk|0.92|||||TWO_SIDED|95.0|0.39|2.21||||||Relative risk versus placebo was provided together with 95% CIs.||2.21|0.39|
71036781|NCT00205777|141581654|SUPERIORITY_OR_OTHER||Relative risk|1.01|||||TWO_SIDED|95.0|0.5|2.06||||||Relative risk versus placebo was provided together with 95% CIs.||2.06|0.5|
71036782|NCT00205777|141581655|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Log Rank|||||||0.57
71036783|NCT00205777|141581655|SUPERIORITY_OR_OTHER|||||||0.62|TWO_SIDED||||||Log Rank|||||||0.62
71036784|NCT00205777|141581655|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||Log Rank|||||||0.72
71036785|NCT00205777|141581655|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Log Rank|||||||0.67
71036786|NCT00205777|141581655|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||Log Rank|||||||0.89
71097502|NCT01026038|141703957|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Fisher Exact|||Pain (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||>0.990
70983518|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.3|||||TWO_SIDED|95.0|0.94|1.75|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.75|0.94|
70983519|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.32|2.19|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.19|1.32|
70983520|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.4|||||TWO_SIDED|95.0|1.14|1.6|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.60|1.14|
70983521|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.6|||||TWO_SIDED|95.0|1.2|2.01|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.01|1.20|
70983522|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.24|2.26|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.26|1.24|
70983523|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|3.1|||||TWO_SIDED|95.0|2.26|4.3|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||4.30|2.26|
70983524|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.0|||||TWO_SIDED|95.0|1.53|2.75|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.75|1.53|
70983525|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.48|2.95|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.95|1.48|
70983526|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.7|||||TWO_SIDED|95.0|1.97|3.7|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||3.70|1.97|
70983527|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.9|||||TWO_SIDED|95.0|1.99|4.29|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||4.29|1.99|
70983528|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.6|||||TWO_SIDED|95.0|1.23|2.05|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.05|1.23|
70983529|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.4|||||TWO_SIDED|95.0|1.18|1.78|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.78|1.18|
71036787|NCT00205777|141581655|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||Log Rank|||||||0.95
71036788|NCT00205777|141581656|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Log Rank|||||||0.29
71036789|NCT00205777|141581656|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||Log Rank|||||||0.31
71036790|NCT00205777|141581656|SUPERIORITY_OR_OTHER|||||||0.94|TWO_SIDED||||||Log Rank|||||||0.94
71036791|NCT00205777|141581657|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Log Rank|||||||0.18
71036792|NCT00205777|141581661|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.||||0.46
71036793|NCT00205777|141581661|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.||||0.90
71036794|NCT00205777|141581661|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.||||0.93
71036795|NCT00205777|141581661|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.||||0.84
71036796|NCT00205777|141581661|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.||||0.39
71036797|NCT00205777|141581661|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.||||0.52
71036798|NCT00205777|141581661|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Log Rank|||Hip: P value was calculated using Log-Rank test.||||0.28
71036799|NCT00205777|141581661|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||Log Rank|||Hip: P value was calculated using Log-Rank test.||||0.31
70983530|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.04|1.42|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.42|1.04|
70983531|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.82|1.19|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.19|0.82|
70983532|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.96|1.29|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.29|0.96|
70983533|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.89|1.2|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.20|0.89|
70983534|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.07|1.46|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.46|1.07|
70983535|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.4|||||TWO_SIDED|95.0|1.24|1.61|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.61|1.24|
70983536|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.96|1.27|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.27|0.96|
70983537|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rises|2.1|||||TWO_SIDED|95.0|1.56|2.8|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.80|1.56|
70983538|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.3|||||TWO_SIDED|95.0|1.82|2.88|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.88|1.82|
70983539|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.5|||||TWO_SIDED|95.0|1.18|1.9|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.90|1.18|
70983540|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.89|1.48|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.48|0.89|
71036800|NCT00205777|141581661|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||Log Rank|||Hip: P value was calculated using Log-Rank test.||||0.17
71036801|NCT00205777|141581661|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||Log Rank|||Hip: P value was calculated using Log-Rank test.||||0.72
71036802|NCT00205777|141581661|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Log Rank|||Hip: P value was calculated using Log-Rank test.||||0.97
71036803|NCT00205777|141581661|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Log Rank|||Hip: P value was calculated using Log-Rank test.||||0.76
71036804|NCT00205777|141581661|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.||||0.29
71036805|NCT00205777|141581661|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.||||0.43
71036806|NCT00205777|141581661|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.||||0.59
71036807|NCT00205777|141581661|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.||||0.19
70983541|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.63|0.85|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.85|0.63|
70983542|NCT01025336|141476214|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|0.99|1.51|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.51|0.99|
70983543|NCT01025336|141476215|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.03|1.31|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.31|1.03|
71036808|NCT00205777|141581661|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.||||0.80
71036809|NCT00205777|141581661|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.||||0.11
70983544|NCT01025336|141476215|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.91|1.16|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.16|0.91|
70983545|NCT01025336|141476215|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.07|1.37|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.37|1.07|
70983546|NCT01025336|141476215|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.91|1.13|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.13|0.91|
71036810|NCT00205777|141581662|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.012||||0.968|TWO_SIDED|95.0|0.79|1.296|||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.296|0.790|0.968
71036811|NCT00205777|141581662|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.846||||0.211|TWO_SIDED|95.0|0.652|1.097|||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 40/20 mg \[SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.097|0.652|0.211
71036812|NCT00205777|141581662|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.191|TWO_SIDED|95.0|0.925|1.556|||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40/20 mg \[SE I\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.556|0.925|0.191
71036813|NCT00205777|141581662|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.406||||0.493|TWO_SIDED|95.0|0.566|3.497|||Log Rank|||Hip: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||3.497|0.566|0.493
71036814|NCT00205777|141581662|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.872||||0.82|TWO_SIDED|95.0|0.316|2.405|||Log Rank|||Hip: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 40/20 mg \[SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||2.405|0.316|0.820
71036815|NCT00205777|141581662|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.612||||0.371|TWO_SIDED|95.0|0.624|4.161|||Log Rank|||Hip: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40/20 mg \[SE I\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||4.161|0.624|0.371
71036816|NCT00205777|141581662|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.202||||0.423|TWO_SIDED|95.0|0.776|1.861|||Log Rank|||Wrist: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.861|0.776|0.423
71036817|NCT00205777|141581662|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.936||||0.799|TWO_SIDED|95.0|0.587|1.491|||Log Rank|||Wrist: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 40/20 mg \[SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.491|0.587|0.799
71036818|NCT00205777|141581662|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.28||||0.298|TWO_SIDED|95.0|0.818|2.002|||Log Rank|||Wrist: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40/20 mg \[SE I\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||2.002|0.818|0.298
71097503|NCT01026038|141703957|SUPERIORITY_OR_OTHER|||||||0.429||95.0|||||Fisher Exact|||Pain (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.429
71036819|NCT00205777|141581663|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.73|TWO_SIDED|95.0|0.78|1.19|||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[SE II\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.19|0.78|0.73
71036820|NCT00205777|141581663|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.71|TWO_SIDED|95.0|0.41|1.83|||Log Rank|||Hip: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[SE II\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.83|0.41|0.71
71036821|NCT00205777|141581663|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.45|TWO_SIDED|95.0|0.8|1.66|||Log Rank|||Wrist: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[SE II\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.66|0.80|0.45
71036822|NCT00205777|141581664|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||ANCOVA|||||||0.31
71036823|NCT00205777|141581664|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED||||||ANCOVA|||||||0.039
71036824|NCT00205777|141581664|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||ANCOVA|||||||0.13
71036825|NCT00205777|141581664|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||ANCOVA|||||||0.12
71036826|NCT00205777|141581664|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANCOVA|||||||0.002
71036827|NCT00205777|141581665|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||ANCOVA|||||||0.12
71036828|NCT00205777|141581665|SUPERIORITY_OR_OTHER|||||||0.94|TWO_SIDED||||||ANCOVA|||||||0.94
71036829|NCT00205777|141581666|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||ANCOVA|||||||0.26
71097504|NCT01026038|141703957|SUPERIORITY_OR_OTHER|||||||0.314||95.0|||||Fisher Exact|||Pain (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.314
71097505|NCT01026038|141703957|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Pain (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||>0.990
71036830|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in lumbar spine BMD: P value was calculated using Analysis of covariance (ANCOVA).||||<0.001
71036831|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71036832|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71036833|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71036834|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71036835|NCT00205777|141581667|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.018
71036836|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71036837|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71036838|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71036839|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71036840|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71036841|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71036842|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71036843|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71036844|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71036845|NCT00205777|141581667|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.036
71036846|NCT00205777|141581667|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.003
71036847|NCT00205777|141581667|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.019
71036848|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71036849|NCT00205777|141581667|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.002
71036850|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71036851|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71036852|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71036853|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71036854|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71097506|NCT01026038|141703957|SUPERIORITY_OR_OTHER|||||||0.552||95.0|||||Fisher Exact|||Pain (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.552
71036855|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
70983547|NCT01025336|141476215|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.6|2.68|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.68|1.60|
70983548|NCT01025336|141476215|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.4|||||TWO_SIDED|95.0|1.82|3.24|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||3.24|1.82|
70983549|NCT01025336|141476215|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.8|||||TWO_SIDED|95.0|1.55|2.03|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.03|1.55|
70983550|NCT01025336|141476215|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.8|||||TWO_SIDED|95.0|1.54|2.09|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.09|1.54|
70983551|NCT01025336|141476215|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.79|1.07|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.07|0.79|
70983552|NCT01025336|141476215|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.48|2.55|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.55|1.48|
70983553|NCT01025336|141476215|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.05|1.53|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.53|1.05|
70983554|NCT01025336|141476215|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.5|2.51|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.51|1.50|
71097507|NCT01026038|141703957|SUPERIORITY_OR_OTHER|||||||0.499||95.0|||||Fisher Exact|||Pain (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.499
70983555|NCT01025336|141476215|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.6|||||TWO_SIDED|95.0|1.98|3.5|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||3.50|1.98|
70983556|NCT01025336|141476215|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.31|2.18|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.18|1.31|
70983557|NCT01025336|141476215|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.37|2.61|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.61|1.37|
70983558|NCT01025336|141476215|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.4|||||TWO_SIDED|95.0|1.76|3.38|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||3.38|1.76|
70983559|NCT01025336|141476215|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.6|||||TWO_SIDED|95.0|1.33|1.86|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.86|1.33|
70983560|NCT01025336|141476215|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.38|2.01|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.01|1.38|
71036856|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71036857|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71036858|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71036859|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71097508|NCT01026038|141703957|SUPERIORITY_OR_OTHER|||||||0.376||95.0|||||Fisher Exact|||Pain (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.376
70983561|NCT01025336|141476215|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.1|1.42|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.42|1.10|
70983562|NCT01025336|141476215|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.14|1.55|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.55|1.14|
70983563|NCT01025336|141476215|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.14|1.43|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.43|1.14|
70983564|NCT01025336|141476215|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.5|||||TWO_SIDED|95.0|1.28|1.67|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.67|1.28|
70983565|NCT01025336|141476215|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.2|||||TWO_SIDED|95.0|1.8|2.6|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.60|1.80|
70983566|NCT01025336|141476215|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.53|2.31|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.31|1.53|
70983567|NCT01025336|141476215|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.44|2.06|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.06|1.44|
70983568|NCT01025336|141476215|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.5|||||TWO_SIDED|95.0|1.24|1.84|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.84|1.24|
70983569|NCT01025336|141476216|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.19|0.29|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.29|0.19|
70983570|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.17|0.25|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.25|0.17|
71097509|NCT01026038|141703957|SUPERIORITY_OR_OTHER|||||||0.633||95.0|||||Fisher Exact|||Pain (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.633
70983571|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.2|0.29|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.29|0.20|
70983572|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.2|0.3|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.30|0.20|
70983573|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.31|0.42|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.42|0.31|
70983574|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.18|0.26|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.26|0.18|
70983575|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.1|||||TWO_SIDED|95.0|0.1|0.18|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.18|0.10|
70983576|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.12|0.2|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.20|0.12|
71097510|NCT01026038|141703957|SUPERIORITY_OR_OTHER|||||||0.658||95.0|||||Fisher Exact|||Pain (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.658
71097511|NCT01026038|141703957|SUPERIORITY_OR_OTHER|||||||0.544||95.0|||||Fisher Exact|||Pain (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.544
70983577|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.1|||||TWO_SIDED|95.0|0.1|0.18|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.18|0.10|
70983578|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.13|0.22|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.22|0.13|
70983579|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.22|0.33|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.33|0.22|
70983580|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.25|0.38|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.38|0.25|
70983581|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.1|||||TWO_SIDED|95.0|0.08|0.14|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.14|0.08|
70983582|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.1|||||TWO_SIDED|95.0|0.06|0.1|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.10|0.06|
70983583|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.22|0.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.46|0.22|
70983584|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.4|0.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.60|0.40|
70983585|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.29|0.43|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.43|0.29|
70983586|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.29|0.59|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.59|0.29|
70983587|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.17|0.38|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.38|0.17|
70983588|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.21|0.36|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.36|0.21|
70983589|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.27|0.56|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.56|0.27|
70983590|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.13|0.28|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.28|0.13|
70983591|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.2|0.39|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.39|0.20|
70983592|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.28|0.67|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.67|0.28|
70983593|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.48|0.83|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.83|0.48|
70983594|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.49|0.74|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.74|0.49|
71097512|NCT01026038|141703957|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Pain (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
70983595|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.42|0.65|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.65|0.42|
70983596|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.2|0.32|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.32|0.20|
70983597|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.28|0.43|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.43|0.28|
70983598|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.29|0.45|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.45|0.29|
70983599|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.3|0.41|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.41|0.30|
70983600|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.35|0.45|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.45|0.35|
70983601|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.36|0.51|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.51|0.36|
70983602|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.35|0.58|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.58|0.35|
70983603|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.39|0.62|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.62|0.39|
70983604|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.34|0.54|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.54|0.34|
70983605|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.23|0.42|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.42|0.23|
70983606|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.15|0.24|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.24|0.15|
70983607|NCT01025336|141476216|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.42|0.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.69|0.42|
70983608|NCT01025336|141476217|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.36|0.5|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.50|0.36|
70983609|NCT01025336|141476217|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.36|0.48|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.48|0.36|
70983610|NCT01025336|141476217|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.33|0.44|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.44|0.33|
71097513|NCT01026038|141703957|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Pain (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
70983611|NCT01025336|141476217|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.26|0.37|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.37|0.26|
70983612|NCT01025336|141476217|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.42|0.68|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.68|0.42|
71097514|NCT01026038|141703957|SUPERIORITY_OR_OTHER|||||||0.859||95.0|||||Fisher Exact|||Swelling (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.859
70983613|NCT01025336|141476217|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.64|1.14|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.14|0.64|
70983614|NCT01025336|141476217|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.6|0.82|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.82|0.60|
70983615|NCT01025336|141476217|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.86|1.18|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.18|0.86|
70983616|NCT01025336|141476217|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.22|0.33|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.33|0.22|
70983617|NCT01025336|141476217|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.81|1.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.46|0.81|
70983618|NCT01025336|141476217|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.34|0.51|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.51|0.34|
70983619|NCT01025336|141476217|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.66|1.09|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.09|0.66|
70983620|NCT01025336|141476217|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.37|0.68|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.68|0.37|
70983621|NCT01025336|141476217|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.43|0.77|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.77|0.43|
70983622|NCT01025336|141476217|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.3|0.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.60|0.30|
70983623|NCT01025336|141476217|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.47|0.98|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.98|0.47|
70983624|NCT01025336|141476217|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.72|1.01|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.01|0.72|
70983625|NCT01025336|141476217|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.71|1.0|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.00|0.71|
70983626|NCT01025336|141476217|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.5|0.66|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.66|0.50|
71097515|NCT01026038|141703957|SUPERIORITY_OR_OTHER|||||||0.197||95.0|||||Fisher Exact|||Swelling (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.197
70983627|NCT01025336|141476217|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.56|0.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.80|0.56|
70983628|NCT01025336|141476217|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.54|0.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.69|0.54|
70983629|NCT01025336|141476217|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.78|1.05|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.05|0.78|
70983630|NCT01025336|141476217|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.59|0.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.80|0.59|
70983631|NCT01025336|141476217|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.53|0.83|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.83|0.53|
70983632|NCT01025336|141476217|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.51|0.74|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.74|0.51|
70983633|NCT01025336|141476217|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.75|1.15|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.15|0.75|
70983634|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.0|||||TWO_SIDED|95.0|6.05|10.67|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||10.67|6.05|
70983635|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.3|||||TWO_SIDED|95.0|6.65|10.45|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||10.45|6.65|
70983636|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.8|||||TWO_SIDED|95.0|3.71|6.14|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||6.14|3.71|
70983637|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.2|||||TWO_SIDED|95.0|2.59|3.91|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.91|2.59|
70983638|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.4|||||TWO_SIDED|95.0|3.67|5.26|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||5.26|3.67|
70983639|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.6|||||TWO_SIDED|95.0|2.2|3.14|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.14|2.20|
70983640|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.9|||||TWO_SIDED|95.0|7.8|21.34|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||21.34|7.80|
70983641|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|9.0|||||TWO_SIDED|95.0|6.26|12.92|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||12.92|6.26|
70983642|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.5|||||TWO_SIDED|95.0|3.71|8.07|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||8.07|3.71|
70983643|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.2|||||TWO_SIDED|95.0|4.35|8.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||8.80|4.35|
70983644|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.6|||||TWO_SIDED|95.0|9.71|16.3|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||16.30|9.71|
70983645|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.5|||||TWO_SIDED|95.0|5.59|10.02|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||10.02|5.59|
70983646|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|15.1|||||TWO_SIDED|95.0|9.56|23.81|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||23.81|9.56|
70983647|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.3|||||TWO_SIDED|95.0|8.66|17.38|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||17.38|8.66|
70983648|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.5|||||TWO_SIDED|95.0|4.29|9.89|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||9.89|4.29|
70983649|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|20.8|||||TWO_SIDED|95.0|12.59|34.24|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||34.24|12.59|
70983650|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|21.4|||||TWO_SIDED|95.0|14.56|31.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||31.46|14.56|
70983651|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.1|||||TWO_SIDED|95.0|7.24|17.01|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||17.01|7.24|
70983652|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|32.2|||||TWO_SIDED|95.0|19.75|52.57|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||52.57|19.75|
70983653|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|47.2|||||TWO_SIDED|95.0|34.0|65.43|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||65.43|34.00|
70983654|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|19.4|||||TWO_SIDED|95.0|12.95|29.17|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||29.17|12.95|
70983655|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.8|||||TWO_SIDED|95.0|7.79|21.13|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||21.13|7.79|
70983656|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.6|||||TWO_SIDED|95.0|8.56|18.68|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||18.68|8.56|
70983657|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.8|||||TWO_SIDED|95.0|4.54|10.1|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||10.10|4.54|
70983658|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.8|||||TWO_SIDED|95.0|8.16|20.02|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||20.02|8.16|
70983659|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.5|||||TWO_SIDED|95.0|8.15|16.23|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||16.23|8.15|
70983660|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.0|||||TWO_SIDED|95.0|5.75|11.25|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||11.25|5.75|
71036860|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71036861|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71036862|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71036863|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71036864|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
70983661|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|20.0|||||TWO_SIDED|95.0|12.99|30.76|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||30.76|12.99|
70983662|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|22.3|||||TWO_SIDED|95.0|16.5|30.06|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||30.06|16.50|
70983663|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|9.8|||||TWO_SIDED|95.0|7.07|13.63|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||13.63|7.07|
70983664|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.0|||||TWO_SIDED|95.0|8.82|16.34|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||16.34|8.82|
70983665|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|13.0|||||TWO_SIDED|95.0|10.21|16.66|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||16.66|10.21|
70983666|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.6|||||TWO_SIDED|95.0|5.86|9.94|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||9.94|5.86|
70983667|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.2|||||TWO_SIDED|95.0|8.05|18.34|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||18.34|8.05|
70983668|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|17.2|||||TWO_SIDED|95.0|12.77|23.24|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||23.24|12.77|
70983669|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.5|||||TWO_SIDED|95.0|8.01|16.45|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||16.45|8.01|
70983670|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.0|||||TWO_SIDED|95.0|7.89|18.19|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||18.19|7.89|
70983671|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.7|||||TWO_SIDED|95.0|5.02|8.92|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||8.92|5.02|
70983672|NCT01025336|141476218|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.7|||||TWO_SIDED|95.0|3.52|6.29|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||6.29|3.52|
71036865|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71036866|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71036867|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71036868|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71036869|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71036870|NCT00205777|141581667|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.||||0.008
71036871|NCT00205777|141581667|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.||||0.007
71036872|NCT00205777|141581667|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.||||0.002
71036873|NCT00205777|141581667|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.||||0.002
70983673|NCT01025336|141476219|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.7|||||TWO_SIDED|95.0|3.05|4.49|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||4.49|3.05|
70983674|NCT01025336|141476219|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.3|||||TWO_SIDED|95.0|1.92|2.81|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||2.81|1.92|
70983675|NCT01025336|141476219|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.83|2.5|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||2.50|1.83|
70983676|NCT01025336|141476219|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.5|||||TWO_SIDED|95.0|1.32|1.74|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||1.74|1.32|
70983677|NCT01025336|141476219|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.0|||||TWO_SIDED|95.0|5.82|11.09|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||11.09|5.82|
70983678|NCT01025336|141476219|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.9|||||TWO_SIDED|95.0|4.25|8.21|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||8.21|4.25|
70983679|NCT01025336|141476219|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.9|||||TWO_SIDED|95.0|3.96|6.0|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||6.00|3.96|
70983680|NCT01025336|141476219|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.1|||||TWO_SIDED|95.0|2.58|3.79|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.79|2.58|
70983681|NCT01025336|141476219|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.9|||||TWO_SIDED|95.0|8.56|16.49|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||16.49|8.56|
70983682|NCT01025336|141476219|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.5|||||TWO_SIDED|95.0|2.59|4.76|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||4.76|2.59|
70983683|NCT01025336|141476219|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.5|||||TWO_SIDED|95.0|4.61|9.03|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||9.03|4.61|
70983684|NCT01025336|141476219|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.1|||||TWO_SIDED|95.0|2.32|4.24|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||4.24|2.32|
70983685|NCT01025336|141476219|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.4|||||TWO_SIDED|95.0|5.23|10.33|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||10.33|5.23|
70983686|NCT01025336|141476219|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.6|||||TWO_SIDED|95.0|4.07|7.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||7.69|4.07|
71036874|NCT00205777|141581667|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.||||0.006
71036875|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71036876|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71036877|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71036878|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71036879|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71036880|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
70983687|NCT01025336|141476219|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.6|||||TWO_SIDED|95.0|2.5|5.2|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||5.20|2.50|
70983688|NCT01025336|141476219|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.9|||||TWO_SIDED|95.0|2.1|4.04|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||4.04|2.10|
70983689|NCT01025336|141476219|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.9|||||TWO_SIDED|95.0|2.26|3.71|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.71|2.26|
71036881|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71036882|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71036883|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71036884|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71036885|NCT00205777|141581667|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.||||0.47
71036886|NCT00205777|141581667|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.||||0.005
71097516|NCT01026038|141703957|SUPERIORITY_OR_OTHER|||||||0.198||95.0|||||Fisher Exact|||Swelling (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.198
71097517|NCT01026038|141703957|SUPERIORITY_OR_OTHER|||||||0.443||95.0|||||Fisher Exact|||Swelling (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.443
71097518|NCT01026038|141703957|SUPERIORITY_OR_OTHER|||||||0.261||95.0|||||Fisher Exact|||Swelling (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.261
71097519|NCT01026038|141703957|SUPERIORITY_OR_OTHER|||||||0.687||95.0|||||Fisher Exact|||Swelling (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.687
71097520|NCT01026038|141703957|SUPERIORITY_OR_OTHER|||||||0.671||95.0|||||Fisher Exact|||Swelling (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.671
71097521|NCT01026038|141703957|SUPERIORITY_OR_OTHER|||||||0.253||95.0|||||Fisher Exact|||Swelling (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.253
71097522|NCT01026038|141703957|SUPERIORITY_OR_OTHER|||||||0.074||95.0|||||Fisher Exact|||Swelling (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.074
71036887|NCT00205777|141581667|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.||||0.002
71036888|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71036889|NCT00205777|141581667|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.||||0.004
71036890|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71036891|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71036892|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71036893|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71036894|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71036895|NCT00205777|141581667|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.||||0.39
71036896|NCT00205777|141581667|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.||||0.17
71036897|NCT00205777|141581667|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.||||0.34
71097523|NCT01026038|141703957|SUPERIORITY_OR_OTHER|||||||0.323||95.0|||||Fisher Exact|||Swelling (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.323
71097524|NCT01026038|141703957|SUPERIORITY_OR_OTHER|||||||0.489||95.0|||||Fisher Exact|||Swelling (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.489
71097525|NCT01026038|141703957|SUPERIORITY_OR_OTHER|||||||0.607||95.0|||||Fisher Exact|||Redness (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.607
70983690|NCT01025336|141476219|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.8|||||TWO_SIDED|95.0|2.23|3.63|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.63|2.23|
70983691|NCT01025336|141476219|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.1|||||TWO_SIDED|95.0|3.16|5.2|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||5.20|3.16|
70983692|NCT01025336|141476219|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.5|||||TWO_SIDED|95.0|2.06|3.14|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.14|2.06|
70983693|NCT01025336|141476219|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.0|||||TWO_SIDED|95.0|2.46|3.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.60|2.46|
70983694|NCT01025336|141476219|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.7|||||TWO_SIDED|95.0|2.24|3.15|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.15|2.24|
70983695|NCT01025336|141476219|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.9|||||TWO_SIDED|95.0|4.55|7.76|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||7.76|4.55|
71097526|NCT01026038|141703957|SUPERIORITY_OR_OTHER|||||||0.549||95.0|||||Fisher Exact|||Redness (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.549
71097527|NCT01026038|141703957|SUPERIORITY_OR_OTHER|||||||0.864||95.0|||||Fisher Exact|||Redness (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.864
71097528|NCT01026038|141703957|SUPERIORITY_OR_OTHER|||||||0.859||95.0|||||Fisher Exact|||Redness (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.859
71097529|NCT01026038|141703957|SUPERIORITY_OR_OTHER|||||||0.836||95.0|||||Fisher Exact|||Redness (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.836
71097530|NCT01026038|141703957|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Redness (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
70983696|NCT01025336|141476219|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.0|||||TWO_SIDED|95.0|3.13|5.17|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||5.17|3.13|
70983697|NCT01025336|141476219|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.9|||||TWO_SIDED|95.0|5.16|9.25|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||9.25|5.16|
71097531|NCT01026038|141703957|SUPERIORITY_OR_OTHER|||||||0.297||95.0|||||Fisher Exact|||Redness (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.297
71097532|NCT01026038|141703957|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||Fisher Exact|||Redness (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.145
70983698|NCT01025336|141476219|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.8|||||TWO_SIDED|95.0|2.24|3.4|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.40|2.24|
70983699|NCT01025336|141476220|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|1.02|2.08|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 1: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.08|1.02|
71097533|NCT01026038|141703957|SUPERIORITY_OR_OTHER|||||||0.517||95.0|||||Fisher Exact|||Redness (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.517
71097534|NCT01026038|141703957|SUPERIORITY_OR_OTHER|||||||0.323||95.0|||||Fisher Exact|||Redness (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.323
71097535|NCT01026038|141703957|SUPERIORITY_OR_OTHER|||||||0.489||95.0|||||Fisher Exact|||Redness (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.489
71036898|NCT00205777|141581667|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.||||0.016
71036899|NCT00205777|141581667|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.||||0.47
71036900|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71097536|NCT01026038|141703958|SUPERIORITY_OR_OTHER|||||||0.075|TWO_SIDED||||||Fisher Exact|||Fever (\>=38 degree C to \<=39 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC||||0.075
71097537|NCT01026038|141703958|SUPERIORITY_OR_OTHER|||||||0.345||95.0|||||Fisher Exact|||Fever (\>=38 degree C to \<=39 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC||||0.345
70983700|NCT01025336|141476220|SUPERIORITY_OR_OTHER||Ratio|1.5|||||TWO_SIDED|95.0|1.14|1.99|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 3: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.99|1.14|
70983701|NCT01025336|141476220|SUPERIORITY_OR_OTHER||Ratio|1.9|||||TWO_SIDED|95.0|1.22|3.06|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 4: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||3.06|1.22|
70983702|NCT01025336|141476220|SUPERIORITY_OR_OTHER||Ratio|1.7|||||TWO_SIDED|95.0|1.15|2.56|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 5: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.56|1.15|
70983703|NCT01025336|141476220|SUPERIORITY_OR_OTHER||Ratio|2.2|||||TWO_SIDED|95.0|1.36|3.53|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 6A: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||3.53|1.36|
70983704|NCT01025336|141476220|SUPERIORITY_OR_OTHER||Ratio|1.8|||||TWO_SIDED|95.0|1.15|2.91|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 6B: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.91|1.15|
70983705|NCT01025336|141476220|SUPERIORITY_OR_OTHER||Ratio|2.8|||||TWO_SIDED|95.0|1.8|4.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 7F: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||4.44|1.80|
70983706|NCT01025336|141476220|SUPERIORITY_OR_OTHER||Ratio|1.7|||||TWO_SIDED|95.0|0.99|2.96|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 9V: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.96|0.99|
71036901|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71036902|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
70983707|NCT01025336|141476220|SUPERIORITY_OR_OTHER||Ratio|1.1|||||TWO_SIDED|95.0|0.73|1.62|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 14: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.62|0.73|
70983708|NCT01025336|141476220|SUPERIORITY_OR_OTHER||Ratio|1.6|||||TWO_SIDED|95.0|1.02|2.39|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 18C: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.39|1.02|
70983709|NCT01025336|141476220|SUPERIORITY_OR_OTHER||Ratio|1.8|||||TWO_SIDED|95.0|1.38|2.45|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 19A: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.45|1.38|
70983710|NCT01025336|141476220|SUPERIORITY_OR_OTHER||Ratio|2.2|||||TWO_SIDED|95.0|1.53|3.12|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 19F: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||3.12|1.53|
71036903|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71036904|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71036905|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71097538|NCT01026038|141703958|SUPERIORITY_OR_OTHER|||||||0.628||95.0|||||Fisher Exact|||Fever (\>=38 degree C to \<=39 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC||||0.628
71036906|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
70983711|NCT01025336|141476220|SUPERIORITY_OR_OTHER||Ratio|1.8|||||TWO_SIDED|95.0|1.18|2.82|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 23F: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.82|1.18|
70983712|NCT01025336|141476221|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|1.02|2.25|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 1: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.25|1.02|
70983713|NCT01025336|141476221|SUPERIORITY_OR_OTHER||Ratio of GMT|1.1|||||TWO_SIDED|95.0|0.78|1.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 3: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.44|0.78|
70983714|NCT01025336|141476221|SUPERIORITY_OR_OTHER||Ratio of GMT|1.8|||||TWO_SIDED|95.0|1.06|3.0|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 4: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||3.00|1.06|
70983715|NCT01025336|141476221|SUPERIORITY_OR_OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.41|1.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 5: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.04|0.41|
70983716|NCT01025336|141476221|SUPERIORITY_OR_OTHER||Ratio of GMT|3.1|||||TWO_SIDED|95.0|1.82|5.24|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 6A: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||5.24|1.82|
70983717|NCT01025336|141476221|SUPERIORITY_OR_OTHER||Ratio of GMT|2.4|||||TWO_SIDED|95.0|1.43|4.11|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 6B: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||4.11|1.43|
70983718|NCT01025336|141476221|SUPERIORITY_OR_OTHER||Ratio of GMT|1.7|||||TWO_SIDED|95.0|0.96|3.0|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 7F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||3.00|0.96|
71036907|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71036908|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71036909|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71036910|NCT00205777|141581667|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.||||0.01
70983719|NCT01025336|141476221|SUPERIORITY_OR_OTHER||Ratio of GMT|1.6|||||TWO_SIDED|95.0|0.88|3.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 9V: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||3.04|0.88|
70983720|NCT01025336|141476221|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.64|1.54|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 14: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.54|0.64|
70983721|NCT01025336|141476221|SUPERIORITY_OR_OTHER||Ratio of GMT|1.2|||||TWO_SIDED|95.0|0.71|1.93|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 18C: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.93|0.71|
70983722|NCT01025336|141476221|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|1.01|2.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 19A: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.04|1.01|
70983723|NCT01025336|141476221|SUPERIORITY_OR_OTHER||Ratio of GMT|1.3|||||TWO_SIDED|95.0|0.84|2.06|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 19F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.06|0.84|
71036911|NCT00205777|141581667|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.||||0.002
71036912|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71036913|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71036914|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71036915|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71036916|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71036917|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71036918|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71036919|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71036920|NCT00205777|141581667|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.||||0.048
71036921|NCT00205777|141581667|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.||||0.038
71036922|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71036923|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71036924|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71097539|NCT01026038|141703958|SUPERIORITY_OR_OTHER|||||||0.592||95.0|||||Fisher Exact|||Fever (\>=39 degree C to \<=40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.592
71097540|NCT01026038|141703958|SUPERIORITY_OR_OTHER|||||||0.608||95.0|||||Fisher Exact|||Fever (\>=39 degree C to \<=40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.608
71097541|NCT01026038|141703958|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fever (\>=39 degree C to \<=40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
71097542|NCT01026038|141703958|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fever (\>40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
71097543|NCT01026038|141703958|SUPERIORITY_OR_OTHER|||||||0.333||95.0|||||Fisher Exact|||Fever (\>40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.333
71036925|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71036926|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71036927|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71036928|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71036929|NCT00205777|141581667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71036930|NCT00205777|141581668|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71036931|NCT00205777|141581668|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.010
71036932|NCT00205777|141581668|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71036933|NCT00205777|141581668|SUPERIORITY_OR_OTHER|||||||0.023|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.023
71036934|NCT00205777|141581668|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71036935|NCT00205777|141581668|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71036936|NCT00205777|141581668|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71036937|NCT00205777|141581668|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71097544|NCT01026038|141703958|SUPERIORITY_OR_OTHER|||||||0.215||95.0|||||Fisher Exact|||Vomiting (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.215
71097545|NCT01026038|141703958|SUPERIORITY_OR_OTHER|||||||0.714||95.0|||||Fisher Exact|||Vomiting (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.714
71036938|NCT00205777|141581668|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71036939|NCT00205777|141581668|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71036940|NCT00205777|141581668|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71036941|NCT00205777|141581668|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71097546|NCT01026038|141703958|SUPERIORITY_OR_OTHER|||||||0.397||95.0|||||Fisher Exact|||Vomiting (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.397
71097547|NCT01026038|141703958|SUPERIORITY_OR_OTHER|||||||0.215||95.0|||||Fisher Exact|||Vomiting (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.215
71097548|NCT01026038|141703958|SUPERIORITY_OR_OTHER|||||||0.714||95.0|||||Fisher Exact|||Vomiting (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.714
71097549|NCT01026038|141703958|SUPERIORITY_OR_OTHER|||||||0.397||95.0|||||Fisher Exact|||Vomiting (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.397
71097550|NCT01026038|141703958|SUPERIORITY_OR_OTHER|||||||0.161||95.0|||||Fisher Exact|||Diarrhea (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.161
71097551|NCT01026038|141703958|SUPERIORITY_OR_OTHER|||||||0.226||95.0|||||Fisher Exact|||Diarrhea (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.226
71097552|NCT01026038|141703958|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Diarrhea (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
71097553|NCT01026038|141703958|SUPERIORITY_OR_OTHER|||||||0.161||95.0|||||Fisher Exact|||Diarrhea (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.161
71097554|NCT01026038|141703958|SUPERIORITY_OR_OTHER|||||||0.226||95.0|||||Fisher Exact|||Diarrhea (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.226
71036942|NCT00205777|141581668|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71036943|NCT00205777|141581668|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71036944|NCT00205777|141581668|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71036945|NCT00205777|141581668|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71036946|NCT00205777|141581669|SUPERIORITY_OR_OTHER|||||||0.34|||||||ANCOVA|||Percent change at Month 72 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.34
71036947|NCT00205777|141581669|SUPERIORITY_OR_OTHER|||||||0.15|||||||ANCOVA|||Percent change at Month 84 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.15
71036948|NCT00205777|141581669|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 72 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71036949|NCT00205777|141581669|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 84 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71036950|NCT00205777|141581669|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||Percent change at Month 72 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71036951|NCT00205777|141581669|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 84 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71097555|NCT01026038|141703958|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Diarrhea (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
71097556|NCT01026038|141703958|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Diarrhea (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||>0.990
71097557|NCT01026038|141703958|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Diarrhea (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
71097558|NCT01026038|141703958|SUPERIORITY_OR_OTHER|||||||0.237||95.0|||||Fisher Exact|||Fatigue (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.237
71097559|NCT01026038|141703958|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||Fisher Exact|||Fatigue (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.045
71097560|NCT01026038|141703958|SUPERIORITY_OR_OTHER|||||||0.285||95.0|||||Fisher Exact|||Fatigue (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.285
70983724|NCT01025336|141476221|SUPERIORITY_OR_OTHER||Ratio of GMT|3.1|||||TWO_SIDED|95.0|1.89|5.2|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 23F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||5.20|1.89|
70983725|NCT01025336|141476222|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.72|1.51|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 1: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.51|0.72|
70983726|NCT01025336|141476222|SUPERIORITY_OR_OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.52|0.94|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 3: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||0.94|0.52|
70983727|NCT01025336|141476222|SUPERIORITY_OR_OTHER||Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.58|1.47|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 4: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.47|0.58|
70983728|NCT01025336|141476222|SUPERIORITY_OR_OTHER||Ratio of GMT|0.4|||||TWO_SIDED|95.0|0.25|0.59|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 5: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||0.59|0.25|
70983729|NCT01025336|141476222|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|0.85|2.32|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 6A: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.32|0.85|
71036952|NCT00205777|141581669|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANCOVA|||Percent change at Month 72 in femoral trochanter BMD: P value was calculated using ANCOVA.||||0.003
71036953|NCT00205777|141581669|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||Percent change at Month 84 in femoral trochanter BMD: P value was calculated using ANCOVA.||||0.002
71036954|NCT00205777|141581670|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Ranked ANCOVA|||Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
71036955|NCT00205777|141581670|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
71097561|NCT01026038|141703958|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fatigue (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||>0.990
71097562|NCT01026038|141703958|SUPERIORITY_OR_OTHER|||||||0.174||95.0|||||Fisher Exact|||Fatigue (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.174
70983730|NCT01025336|141476222|SUPERIORITY_OR_OTHER||Ratio of GMT|1.3|||||TWO_SIDED|95.0|0.82|2.13|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 6B: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.13|0.82|
70983731|NCT01025336|141476222|SUPERIORITY_OR_OTHER||Ratio of GMT|0.6|||||TWO_SIDED|95.0|0.37|0.97|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 7F: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||0.97|0.37|
70983732|NCT01025336|141476222|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.54|1.7|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 9V: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.70|0.54|
71036956|NCT00205777|141581670|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Ranked ANCOVA|||Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
71036957|NCT00205777|141581670|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED||||||Ranked ANCOVA|||Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.||||0.93
71036958|NCT00205777|141581670|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Ranked ANCOVA|||Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
71036959|NCT00205777|141581670|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
71036960|NCT00205777|141581670|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
71036961|NCT00205777|141581670|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
71036962|NCT00205777|141581670|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Ranked ANCOVA|||Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.||||0.30
71036963|NCT00205777|141581670|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
71097563|NCT01026038|141703958|SUPERIORITY_OR_OTHER|||||||0.125||95.0|||||Fisher Exact|||Fatigue (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.125
70983733|NCT01025336|141476222|SUPERIORITY_OR_OTHER||Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.59|1.41|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 14: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.41|0.59|
71097564|NCT01026038|141703958|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||Fisher Exact|||Fatigue (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.058
70983734|NCT01025336|141476222|SUPERIORITY_OR_OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.48|1.17|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 18C: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.17|0.48|
70983735|NCT01025336|141476222|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.58|1.05|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 19A: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.05|0.58|
70983736|NCT01025336|141476222|SUPERIORITY_OR_OTHER||Ratio of GMT|0.6|||||TWO_SIDED|95.0|0.41|0.88|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 19F: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||0.88|0.41|
70983737|NCT01025336|141476222|SUPERIORITY_OR_OTHER||Ratio of GMT|1.7|||||TWO_SIDED|95.0|1.05|2.81|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 23F: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.81|1.05|
70983738|NCT01025336|141476223|SUPERIORITY_OR_OTHER||Ratio of GMT|1.7|||||TWO_SIDED|95.0|1.27|2.4|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 1: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||2.40|1.27|
70983739|NCT01025336|141476223|SUPERIORITY_OR_OTHER||Ratio of GMT|1.2|||||TWO_SIDED|95.0|0.95|1.59|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 3: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||1.59|0.95|
70983740|NCT01025336|141476223|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|1.03|2.29|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 4: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||2.29|1.03|
71097565|NCT01026038|141703958|SUPERIORITY_OR_OTHER|||||||0.092||95.0|||||Fisher Exact|||Fatigue (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.092
71097566|NCT01026038|141703958|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fatigue (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
70983741|NCT01025336|141476223|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|0.95|1.97|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 5: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||1.97|0.95|
70983742|NCT01025336|141476223|SUPERIORITY_OR_OTHER||Ratio of GMT|2.2|||||TWO_SIDED|95.0|1.42|3.31|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 6A: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||3.31|1.42|
70983743|NCT01025336|141476223|SUPERIORITY_OR_OTHER||Ratio of GMT|1.3|||||TWO_SIDED|95.0|0.88|2.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 6B: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||2.04|0.88|
70983744|NCT01025336|141476223|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|0.95|2.4|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 7F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||2.40|0.95|
70983745|NCT01025336|141476223|SUPERIORITY_OR_OTHER||Ratio of GMT|1.2|||||TWO_SIDED|95.0|0.7|1.99|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 9V: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||1.99|0.70|
71097567|NCT01026038|141703958|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fatigue (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||>0.990
70983746|NCT01025336|141476223|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.57|1.25|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 14: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||1.25|0.57|
71036964|NCT00205777|141581670|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
71036965|NCT00205777|141581670|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
71036966|NCT00205777|141581670|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
71036967|NCT00205777|141581670|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
71036968|NCT00205777|141581670|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
71036969|NCT00205777|141581671|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Ranked ANCOVA|||Percent change at Month 36 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
71036970|NCT00205777|141581671|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Ranked ANCOVA|||Percent change at Month 60 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
71036971|NCT00205777|141581671|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 36 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
71036972|NCT00205777|141581671|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 60 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
71036973|NCT00205777|141581672|SUPERIORITY_OR_OTHER|||||||0.037|||||||Ranked ANCOVA|||Percent change at Month 72 in osteocalcin: P value was calculated using Ranked ANCOVA.||||0.037
71036974|NCT00205777|141581672|SUPERIORITY_OR_OTHER|||||||0.16|||||||Ranked ANCOVA|||Percent change at Month 84 in osteocalcin: P value was calculated using Ranked ANCOVA.||||0.16
71036975|NCT00205777|141581673|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
71036976|NCT00205777|141581673|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
70983747|NCT01025336|141476223|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|1.06|2.12|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 18C: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||2.12|1.06|
71036977|NCT00205777|141581673|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
71036978|NCT00205777|141581673|SUPERIORITY_OR_OTHER|||||||0.4|||||||Ranked ANCOVA|||Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||0.40
71036979|NCT00205777|141581673|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
71036980|NCT00205777|141581673|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
71036981|NCT00205777|141581673|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
71036982|NCT00205777|141581673|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
71036983|NCT00205777|141581673|SUPERIORITY_OR_OTHER|||||||0.004|||||||Ranked ANCOVA|||Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||0.004
71036984|NCT00205777|141581673|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
71036985|NCT00205777|141581673|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
71036986|NCT00205777|141581673|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
71036987|NCT00205777|141581673|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
71036988|NCT00205777|141581673|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
71036989|NCT00205777|141581673|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
71036990|NCT00205777|141581674|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 36 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
71036991|NCT00205777|141581674|SUPERIORITY_OR_OTHER|||||||0.001|||||||Ranked ANCOVA|||Percent change at Month 60 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||0.001
71036992|NCT00205777|141581674|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 36 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
71036993|NCT00205777|141581674|SUPERIORITY_OR_OTHER|||||||0.009|||||||Ranked ANCOVA|||Percent change at Month 60 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||0.009
71036994|NCT00205777|141581675|SUPERIORITY_OR_OTHER|||||||0.034||95.0|||||Ranked ANCOVA|||Percent change at Month 72 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||0.034
71036995|NCT00205777|141581675|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||Ranked ANCOVA|||Percent change at Month 84 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||0.77
71036996|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
71036997|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
70983748|NCT01025336|141476223|SUPERIORITY_OR_OTHER||Ratio of GMT|1.3|||||TWO_SIDED|95.0|0.97|1.69|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 19A: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||1.69|0.97|
70983749|NCT01025336|141476223|SUPERIORITY_OR_OTHER||Ratio of GMT|1.8|||||TWO_SIDED|95.0|1.21|2.53|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 19F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||2.53|1.21|
70983750|NCT01025336|141476223|SUPERIORITY_OR_OTHER||Ratio of GMT|2.3|||||TWO_SIDED|95.0|1.54|3.42|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 23F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||3.42|1.54|
70983751|NCT01025336|141476224|SUPERIORITY_OR_OTHER||Ratio of GMT|1.1|||||TWO_SIDED|95.0|0.8|1.63|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 1: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.63|0.80|
70983752|NCT01025336|141476224|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.77|1.39|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 3: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.39|0.77|
70983753|NCT01025336|141476224|SUPERIORITY_OR_OTHER||Ratio of GMT|1.1|||||TWO_SIDED|95.0|0.68|1.69|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 4: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.69|0.68|
70983754|NCT01025336|141476224|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|1.03|2.31|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 5: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.31|1.03|
70983755|NCT01025336|141476224|SUPERIORITY_OR_OTHER||Ratio of GMT|2.7|||||TWO_SIDED|95.0|1.66|4.55|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 6A: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||4.55|1.66|
70983756|NCT01025336|141476224|SUPERIORITY_OR_OTHER||Ratio of GMT|3.7|||||TWO_SIDED|95.0|2.25|5.94|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 6B: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||5.94|2.25|
70983757|NCT01025336|141476224|SUPERIORITY_OR_OTHER||Ratio of GMT|6.2|||||TWO_SIDED|95.0|3.85|9.98|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 7F: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||9.98|3.85|
70983758|NCT01025336|141476224|SUPERIORITY_OR_OTHER||Ratio of GMT|4.2|||||TWO_SIDED|95.0|2.43|7.4|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 9V: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||7.40|2.43|
70983759|NCT01025336|141476224|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|0.89|2.13|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 14: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.13|0.89|
70983760|NCT01025336|141476224|SUPERIORITY_OR_OTHER||Ratio of GMT|1.7|||||TWO_SIDED|95.0|1.06|2.57|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 18C: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.57|1.06|
71036998|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
71036999|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
71037000|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
71037001|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
71037002|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
71037003|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.||||0.001
71037004|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
71097568|NCT01026038|141703958|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fatigue (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
71097569|NCT01026038|141703958|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fatigue (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
71097570|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|0.75|||||TWO_SIDED|95.0|0.56|1.0||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.00|0.56|
70983761|NCT01025336|141476224|SUPERIORITY_OR_OTHER||Ratio of GMT|2.0|||||TWO_SIDED|95.0|1.5|2.78|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 19A: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.78|1.50|
70983762|NCT01025336|141476224|SUPERIORITY_OR_OTHER||Ratio of GMT|3.4|||||TWO_SIDED|95.0|2.3|5.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 19F: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||5.04|2.30|
70983763|NCT01025336|141476224|SUPERIORITY_OR_OTHER||Ratio of GMT|2.1|||||TWO_SIDED|95.0|1.37|3.37|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 23F: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||3.37|1.37|
70983764|NCT01025336|141476225|SUPERIORITY_OR_OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.48|0.9|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 1: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||0.90|0.48|
70983765|NCT01025336|141476225|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.64|1.09|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 3: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.09|0.64|
70983766|NCT01025336|141476225|SUPERIORITY_OR_OTHER||Ratio of GMT|0.3|||||TWO_SIDED|95.0|0.2|0.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 4: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||0.44|0.20|
70983767|NCT01025336|141476225|SUPERIORITY_OR_OTHER||Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.59|1.26|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 5: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.26|0.59|
71037005|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
71037006|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
71037007|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
71037008|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANCOVA|||Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.||||0.009
71037009|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
71097571|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.73|1.28||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.28|0.73|
70983768|NCT01025336|141476225|SUPERIORITY_OR_OTHER||Ratio of GMT|0.2|||||TWO_SIDED|95.0|0.11|0.26|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 6A: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||0.26|0.11|
70983769|NCT01025336|141476225|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.49|1.22|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 6B: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.22|0.49|
70983770|NCT01025336|141476225|SUPERIORITY_OR_OTHER||Ratio of GMT|1.1|||||TWO_SIDED|95.0|0.68|1.76|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 7F: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.76|0.68|
70983771|NCT01025336|141476225|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|0.9|2.55|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 9V: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.55|0.90|
71037010|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||ANCOVA|||Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.||||0.055
71097572|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC Ratio|1.29|||||TWO_SIDED|95.0|0.92|1.79||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.79|0.92|
70983772|NCT01025336|141476225|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|1.02|2.3|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 14: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.30|1.02|
70983773|NCT01025336|141476225|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.52|1.14|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 18C: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.14|0.52|
70983774|NCT01025336|141476225|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.62|1.08|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 19A: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.08|0.62|
70983775|NCT01025336|141476225|SUPERIORITY_OR_OTHER||Ratio of GMT|1.3|||||TWO_SIDED|95.0|0.89|1.98|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 19F: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.98|0.89|
70983776|NCT01025336|141476225|SUPERIORITY_OR_OTHER||Ratio of GMT|0.4|||||TWO_SIDED|95.0|0.26|0.59|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 23F: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||0.59|0.26|
70983777|NCT01025336|141476226|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.85|1.22|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.22|0.85|
70983778|NCT01025336|141476226|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.82|1.1|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.10|0.82|
70983779|NCT01025336|141476226|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.41|0.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.69|0.41|
70983780|NCT01025336|141476226|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.67|0.87|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.87|0.67|
71037011|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANCOVA|||Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.||||0.004
71037012|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
70983781|NCT01025336|141476226|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.48|0.79|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.79|0.48|
70983782|NCT01025336|141476226|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.32|2.19|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.19|1.32|
70983783|NCT01025336|141476226|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.24|2.26|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.26|1.24|
70983784|NCT01025336|141476226|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.48|2.95|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.95|1.48|
71037013|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
71037014|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
71037015|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
71037016|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in LDL: P value was calculated using ANCOVA.||||<0.001
71037017|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in LDL: P value was calculated using ANCOVA.||||<0.001
71037018|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in LDL: P value was calculated using ANCOVA.||||<0.001
70983785|NCT01025336|141476226|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.6|||||TWO_SIDED|95.0|1.23|2.05|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.05|1.23|
70983786|NCT01025336|141476226|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.82|1.19|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.19|0.82|
70983787|NCT01025336|141476226|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.07|1.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.46|1.07|
70983788|NCT01025336|141476226|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.56|2.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.80|1.56|
71037019|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in LDL: P value was calculated using ANCOVA.||||<0.001
71037020|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in LDL: P value was calculated using ANCOVA.||||<0.001
71037021|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in LDL: P value was calculated using ANCOVA.||||<0.001
71097573|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|0.7|||||TWO_SIDED|95.0|0.49|1.0||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.00|0.49|
71097574|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|0.89|||||TWO_SIDED|95.0|0.62|1.27||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.27|0.62|
71097575|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|1.27|||||TWO_SIDED|95.0|0.84|1.94||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.94|0.84|
71097576|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|0.78|||||TWO_SIDED|95.0|0.58|1.03||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.03|0.58|
70983789|NCT01025336|141476226|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.89|1.48|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.48|0.89|
70983790|NCT01025336|141476227|SUPERIORITY_OR_OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.48|0.92|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 1: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||0.92|0.48|
71037022|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in LDL: P value was calculated using ANCOVA.||||<0.001
71037023|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in LDL: P value was calculated using ANCOVA.||||<0.001
71097577|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|1.01|||||TWO_SIDED|95.0|0.76|1.33||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.33|0.76|
71097578|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|1.29|||||TWO_SIDED|95.0|0.93|1.8||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.80|0.93|
71097579|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|1.04|||||TWO_SIDED|95.0|0.69|1.58||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.58|0.69|
71097580|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|1.3|||||TWO_SIDED|95.0|0.86|1.97||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.97|0.86|
70983791|NCT01025336|141476227|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.76|1.28|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 3: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.28|0.76|
71037024|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in LDL: P value was calculated using ANCOVA.||||<0.001
71037025|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in LDL: P value was calculated using ANCOVA.||||<0.001
70983792|NCT01025336|141476227|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|0.88|2.22|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 4: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.22|0.88|
70983793|NCT01025336|141476227|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|0.93|1.95|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 5: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.95|0.93|
70983794|NCT01025336|141476227|SUPERIORITY_OR_OTHER||Ratio of GMT|0.4|||||TWO_SIDED|95.0|0.27|0.66|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 6A: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||0.66|0.27|
70983795|NCT01025336|141476227|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.64|1.56|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 6B: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.56|0.64|
71037026|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in LDL: P value was calculated using ANCOVA.||||<0.001
71037027|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in LDL: P value was calculated using ANCOVA.||||<0.001
71037028|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||ANCOVA|||Percent change at Month 6 in LDL: P value was calculated using ANCOVA.||||0.012
71097581|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|1.25|||||TWO_SIDED|95.0|0.77|2.03||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.03|0.77|
71097582|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|0.58|||||TWO_SIDED|95.0|0.42|0.78||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.78|0.42|
71097583|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|0.91|||||TWO_SIDED|95.0|0.67|1.23||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.23|0.67|
71097584|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|1.58|||||TWO_SIDED|95.0|1.11|2.25||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.25|1.11|
71097585|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|1.05|||||TWO_SIDED|95.0|0.66|1.68||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.68|0.66|
71097586|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|1.54|||||TWO_SIDED|95.0|0.97|2.44||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.44|0.97|
70983796|NCT01025336|141476227|SUPERIORITY_OR_OTHER||Ratio of GMT|1.9|||||TWO_SIDED|95.0|1.14|3.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 7F: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||3.04|1.14|
70983797|NCT01025336|141476227|SUPERIORITY_OR_OTHER||Ratio of GMT|1.7|||||TWO_SIDED|95.0|1.01|2.85|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 9V: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.85|1.01|
70983798|NCT01025336|141476227|SUPERIORITY_OR_OTHER||Ratio of GMT|1.9|||||TWO_SIDED|95.0|1.26|2.87|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 14: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.87|1.26|
71037029|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in LDL: P value was calculated using ANCOVA.||||<0.001
71037030|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||ANCOVA|||Percent change at Month 24 in LDL: P value was calculated using ANCOVA.||||0.031
71037031|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||ANCOVA|||Percent change at Month 36 in LDL: P value was calculated using ANCOVA.||||0.008
71037032|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in LDL: P value was calculated using ANCOVA.||||<0.001
71037033|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in LDL: P value was calculated using ANCOVA.||||<0.001
71037034|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in LDL: P value was calculated using ANCOVA.||||<0.001
71037035|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in LDL: P value was calculated using ANCOVA.||||<0.001
70983799|NCT01025336|141476227|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.57|1.19|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 18C: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.19|0.57|
70983800|NCT01025336|141476227|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.75|1.31|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 19A: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.31|0.75|
70983801|NCT01025336|141476227|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|0.93|2.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 19F: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.04|0.93|
70983802|NCT01025336|141476227|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.5|1.15|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 23F: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.15|0.50|
70983803|NCT01025336|141476228|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.03|1.31|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.31|1.03|
71097587|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|1.46|||||TWO_SIDED|95.0|0.85|2.51||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.51|0.85|
71097588|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|0.8|||||TWO_SIDED|95.0|0.56|1.15||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.15|0.56|
71097589|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|1.06|||||TWO_SIDED|95.0|0.74|1.52||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.52|0.74|
71097590|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|1.32|||||TWO_SIDED|95.0|0.87|2.01||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.01|0.87|
71097591|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|2.59|||||TWO_SIDED|95.0|1.8|3.73||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||3.73|1.80|
71097592|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|1.26|||||TWO_SIDED|95.0|0.88|1.79||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.79|0.88|
71097593|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|0.49|||||TWO_SIDED|95.0|0.32|0.74||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.74|0.32|
71097594|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|1.06|||||TWO_SIDED|95.0|0.61|1.87||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.87|0.61|
71097595|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|1.19|||||TWO_SIDED|95.0|0.68|2.09||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.09|0.68|
70983804|NCT01025336|141476228|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.07|1.37|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.37|1.07|
70983805|NCT01025336|141476228|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.6|2.68|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.68|1.60|
70983806|NCT01025336|141476228|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.8|||||TWO_SIDED|95.0|1.55|2.03|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.03|1.55|
70983807|NCT01025336|141476228|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.79|1.07|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.07|0.79|
71097596|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|1.12|||||TWO_SIDED|95.0|0.59|2.15||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.15|0.59|
71097597|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|1.15|||||TWO_SIDED|95.0|0.87|1.52||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.52|0.87|
70983808|NCT01025336|141476228|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.05|1.53|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.53|1.05|
70983809|NCT01025336|141476228|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.6|||||TWO_SIDED|95.0|1.98|3.5|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||3.50|1.98|
70983810|NCT01025336|141476228|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.37|2.61|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.61|1.37|
71037036|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||Percent change at Month 6 in HDL: P value was calculated using ANCOVA.||||0.001
71037037|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in HDL: P value was calculated using ANCOVA.||||<0.001
71037038|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||Percent change at Month 24 in HDL: P value was calculated using ANCOVA.||||0.001
71037039|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in HDL: P value was calculated using ANCOVA.||||<0.001
71037040|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||ANCOVA|||Percent change at Month 6 in HDL: P value was calculated using ANCOVA.||||0.10
70983811|NCT01025336|141476228|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.6|||||TWO_SIDED|95.0|1.33|1.86|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.86|1.33|
70983812|NCT01025336|141476228|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.1|1.42|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.42|1.10|
70983813|NCT01025336|141476228|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.14|1.43|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.43|1.14|
70983814|NCT01025336|141476228|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.2|||||TWO_SIDED|95.0|1.8|2.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.60|1.80|
70983815|NCT01025336|141476228|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.44|2.06|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.06|1.44|
70983816|NCT01025336|141476229|SUPERIORITY_OR_OTHER||Ratio|1.2|||||TWO_SIDED|95.0|0.87|1.64|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 1: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||1.64|0.87|
70983817|NCT01025336|141476229|SUPERIORITY_OR_OTHER||Ratio|0.8|||||TWO_SIDED|95.0|0.63|1.08|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 3: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||1.08|0.63|
70983818|NCT01025336|141476229|SUPERIORITY_OR_OTHER||Ratio|1.9|||||TWO_SIDED|95.0|1.25|2.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 4: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||2.80|1.25|
70983819|NCT01025336|141476229|SUPERIORITY_OR_OTHER||Ratio|1.0|||||TWO_SIDED|95.0|0.71|1.53|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 5: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||1.53|0.71|
71037041|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||ANCOVA|||Percent change at Month 12 in HDL: P value was calculated using ANCOVA.||||0.89
70983820|NCT01025336|141476229|SUPERIORITY_OR_OTHER||Ratio|7.3|||||TWO_SIDED|95.0|4.67|11.44|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 6A: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||11.44|4.67|
70983821|NCT01025336|141476229|SUPERIORITY_OR_OTHER||Ratio|2.6|||||TWO_SIDED|95.0|1.61|4.17|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 6B: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||4.17|1.61|
70983822|NCT01025336|141476229|SUPERIORITY_OR_OTHER||Ratio|2.0|||||TWO_SIDED|95.0|1.22|3.29|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 7F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||3.29|1.22|
70983823|NCT01025336|141476229|SUPERIORITY_OR_OTHER||Ratio|1.6|||||TWO_SIDED|95.0|0.96|2.77|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 9V: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||2.77|0.96|
70983824|NCT01025336|141476229|SUPERIORITY_OR_OTHER||Ratio|0.8|||||TWO_SIDED|95.0|0.54|1.28|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 14: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||1.28|0.54|
70983825|NCT01025336|141476229|SUPERIORITY_OR_OTHER||Ratio|1.4|||||TWO_SIDED|95.0|0.92|2.07|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 18C: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||2.07|0.92|
70983826|NCT01025336|141476229|SUPERIORITY_OR_OTHER||Ratio|1.4|||||TWO_SIDED|95.0|1.01|1.83|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 19A: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||1.83|1.01|
70983827|NCT01025336|141476229|SUPERIORITY_OR_OTHER||Ratio|1.2|||||TWO_SIDED|95.0|0.77|1.78|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 19F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||1.78|0.77|
71037042|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||ANCOVA|||Percent change at Month 24 in HDL: P value was calculated using ANCOVA.||||0.60
71037043|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||ANCOVA|||Percent change at Month 36 in HDL: P value was calculated using ANCOVA.||||0.82
70983828|NCT01025336|141476229|SUPERIORITY_OR_OTHER||Ratio|3.0|||||TWO_SIDED|95.0|1.97|4.64|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 23F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||4.64|1.97|
70983829|NCT01025336|141476230|SUPERIORITY_OR_OTHER||Ratio|1.6|||||TWO_SIDED|95.0|1.15|2.15|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 1: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||2.15|1.15|
70983830|NCT01025336|141476230|SUPERIORITY_OR_OTHER||Ratio|1.0|||||TWO_SIDED|95.0|0.76|1.32|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 3: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||1.32|0.76|
70983831|NCT01025336|141476230|SUPERIORITY_OR_OTHER||Ratio|1.8|||||TWO_SIDED|95.0|1.09|3.05|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 4: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||3.05|1.09|
70983832|NCT01025336|141476230|SUPERIORITY_OR_OTHER||Ratio|1.4|||||TWO_SIDED|95.0|0.95|1.96|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 5: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||1.96|0.95|
70983833|NCT01025336|141476230|SUPERIORITY_OR_OTHER||Ratio|4.8|||||TWO_SIDED|95.0|3.05|7.5|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 6A: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||7.50|3.05|
70983834|NCT01025336|141476230|SUPERIORITY_OR_OTHER||Ratio|2.3|||||TWO_SIDED|95.0|1.4|3.64|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 6B: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||3.64|1.40|
70983835|NCT01025336|141476230|SUPERIORITY_OR_OTHER||Ratio|1.0|||||TWO_SIDED|95.0|0.58|1.62|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 7F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||1.62|0.58|
70983836|NCT01025336|141476230|SUPERIORITY_OR_OTHER||Ratio|1.4|||||TWO_SIDED|95.0|0.83|2.32|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 9V: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||2.32|0.83|
70983837|NCT01025336|141476230|SUPERIORITY_OR_OTHER||Ratio|0.9|||||TWO_SIDED|95.0|0.58|1.4|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 14: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||1.40|0.58|
70983838|NCT01025336|141476230|SUPERIORITY_OR_OTHER||Ratio|1.6|||||TWO_SIDED|95.0|1.09|2.41|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 18C: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||2.41|1.09|
70983839|NCT01025336|141476230|SUPERIORITY_OR_OTHER||Ratio|1.5|||||TWO_SIDED|95.0|1.1|2.03|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 19A: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||2.03|1.10|
71037044|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||Percent change at Month 6 in HDL: P value was calculated using ANCOVA.||||0.001
70983840|NCT01025336|141476230|SUPERIORITY_OR_OTHER||Ratio|1.3|||||TWO_SIDED|95.0|0.89|2.02|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 19F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||2.02|0.89|
70983841|NCT01025336|141476230|SUPERIORITY_OR_OTHER||Ratio|1.9|||||TWO_SIDED|95.0|1.27|2.97|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 23F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||2.97|1.27|
70983842|NCT02723630|141476245|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|100.52||||0.8826|TWO_SIDED|90.0|94.84|106.53||P-value for the formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and mean treatment difference.|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||106.53|94.84|0.8826
70983843|NCT02723630|141476245|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|96.03||||0.1095|TWO_SIDED|90.0|92.11|100.12||P-value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and mean treatment difference.|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||100.12|92.11|0.1095
70983844|NCT02723630|141476246|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|100.8||||0.8121|TWO_SIDED|90.0|95.31|106.61||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||106.61|95.31|0.8121
70983845|NCT02723630|141476246|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|96.51||||0.163|TWO_SIDED|90.0|92.53|100.65||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||100.65|92.53|0.1630
71037045|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in HDL: P value was calculated using ANCOVA.||||<0.001
70983846|NCT02723630|141476247|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|99.68||||0.9427|TWO_SIDED|90.0|92.45|107.47||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||107.47|92.45|0.9427
70983847|NCT02723630|141476247|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|93.5||||0.0403|TWO_SIDED|90.0|88.63|98.64||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||98.64|88.63|0.0403
71037046|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||ANCOVA|||Percent change at Month 24 in HDL: P value was calculated using ANCOVA.||||0.012
71037047|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in HDL: P value was calculated using ANCOVA.||||<0.001
71037048|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.083||95.0|||||ANCOVA|||Percent change at Month 6 in HDL: P value was calculated using ANCOVA.||||0.083
71037049|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||ANCOVA|||Percent change at Month 12 in HDL: P value was calculated using ANCOVA.||||0.96
71037050|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||ANCOVA|||Percent change at Month 24 in HDL: P value was calculated using ANCOVA.||||0.84
71037051|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||ANCOVA|||Percent change at Month 36 in HDL: P value was calculated using ANCOVA.||||0.15
71037052|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||ANCOVA|||Percent change at Month 6 in HDL: P value was calculated using ANCOVA.||||0.13
71037053|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in HDL: P value was calculated using ANCOVA.||||<0.001
71037054|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||ANCOVA|||Percent change at Month 24 in HDL: P value was calculated using ANCOVA.||||0.007
71037055|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in HDL: P value was calculated using ANCOVA.||||<0.001
71037056|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||ANCOVA|||Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.||||0.28
71037057|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||ANCOVA|||Percent change at Month 12 in HDL2: P value was calculated using ANCOVA||||0.10
71037058|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||ANCOVA|||Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.||||0.94
71037059|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANCOVA|||Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.||||0.46
71037060|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||ANCOVA|||Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.||||0.63
71037061|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||ANCOVA|||Percent change at Month 12 in HDL2: P value was calculated using ANCOVA.||||0.70
71037062|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.58||95.0|||||ANCOVA|||Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.||||0.58
70983848|NCT02723630|141476248|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|100.29||||0.9373|TWO_SIDED|90.0|94.37|106.58||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||106.58|94.37|0.9373
71097598|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|0.91|||||TWO_SIDED|95.0|0.69|1.2||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.20|0.69|
70983849|NCT02723630|141476248|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|95.17||||0.0682|TWO_SIDED|90.0|91.03|99.5||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||99.50|91.03|0.0682
70983850|NCT02723630|141476249|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|98.73||||0.8448|TWO_SIDED|90.0|88.57|110.06||P value for formulation|Mixed Models Analysis||Geometric Least Squares Mean Ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||110.06|88.57|0.8448
70983851|NCT02723630|141476249|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|90.64||||0.0498|TWO_SIDED|90.0|83.51|98.38||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||98.38|83.51|0.0498
71097599|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|0.79|||||TWO_SIDED|95.0|0.57|1.1||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.10|0.57|
71097600|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|2.14|||||TWO_SIDED|95.0|1.52|3.02||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||3.02|1.52|
71037063|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||ANCOVA|||Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.||||0.29
71037064|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||ANCOVA|||Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.||||0.59
71097601|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|1.64|||||TWO_SIDED|95.0|1.16|2.3||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.30|1.16|
71097602|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|0.76|||||TWO_SIDED|95.0|0.51|1.14||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.14|0.51|
70983852|NCT00479466|141476254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.6|||<|0.001|TWO_SIDED|95.0|-44.0|-17.3|||ANCOVA|||||-17.3|-44.0|<0.001
70983853|NCT00479466|141476254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.6|||<|0.001|TWO_SIDED|95.0|-59.7|-33.4|||ANCOVA|||||-33.4|-59.7|<0.001
70983854|NCT00479466|141476254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.1|||<|0.001|TWO_SIDED|95.0|-64.3|-38.0|||ANCOVA|||||-38.0|-64.3|<0.001
70983855|NCT00479466|141476254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-61.2|||<|0.001|TWO_SIDED|95.0|-74.6|-47.8|||ANCOVA|||||-47.8|-74.6|<0.001
71037065|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||ANCOVA|||Percent change at Month 12 in HDL2: P value was calculated using ANCOVA.||||0.036
71037066|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.57||95.0|||||ANCOVA|||Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.||||0.57
71037067|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||ANCOVA|||Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.||||0.49
71037068|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||ANCOVA|||Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.||||0.038
71037069|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||ANCOVA|||Percent change at Month 12 in HDL2: P value was calculated using ANCOVA.||||0.93
70983856|NCT00479466|141476254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.5|||<|0.001|TWO_SIDED|95.0|-48.6|-22.4|||ANCOVA|||||-22.4|-48.6|<0.001
70983857|NCT00479466|141476255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|||<|0.001|TWO_SIDED|95.0|-1.53|-0.76|||ANCOVA|||||-0.76|-1.53|<0.001
70983858|NCT00479466|141476255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.53|||<|0.001|TWO_SIDED|95.0|-1.91|-1.15|||ANCOVA|||||-1.15|-1.91|<0.001
70983859|NCT00479466|141476255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69|||<|0.001|TWO_SIDED|95.0|-2.07|-1.31|||ANCOVA|||||-1.31|-2.07|<0.001
70983860|NCT00479466|141476255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|||<|0.001|TWO_SIDED|95.0|-2.45|-1.68|||ANCOVA|||||-1.68|-2.45|<0.001
70983861|NCT00479466|141476255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32|||<|0.001|TWO_SIDED|95.0|-1.7|-0.95|||ANCOVA|||||-0.95|-1.70|<0.001
70983862|NCT00479466|141476256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-56.8|||<|0.001|TWO_SIDED|95.0|-79.4|-34.3|||ANCOVA|||||-34.3|-79.4|<0.001
70983863|NCT00479466|141476256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-70.0|||<|0.001|TWO_SIDED|95.0|-91.8|-48.2|||ANCOVA|||||-48.2|-91.8|<0.001
70983864|NCT00479466|141476256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-87.4|||<|0.001|TWO_SIDED|95.0|-109.4|-65.3|||ANCOVA|||||-65.3|-109.4|<0.001
70983865|NCT00479466|141476256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-101.6|||<|0.001|TWO_SIDED|95.0|-124.2|-79.1|||ANCOVA|||||-79.1|-124.2|<0.001
70983866|NCT00479466|141476256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-60.8|||<|0.001|TWO_SIDED|95.0|-82.7|-38.8|||ANCOVA|||||-38.8|-82.7|<0.001
70983867|NCT02255838|141476261|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|paired t-test||||||<0.05
70983868|NCT01184989|141476269|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability analysis|Ratio|102.16|STANDARD_DEVIATION|22.8||||90.0|97.64|106.893|||Geometric Mean||Dispersion value is actually the intraindividual gCV.|Estimated local measurements are compared to HPLC-MS/MS measurements. The comparison was done for the 136 quantifiable measurements.||106.893|97.640|
70983869|NCT01184989|141476270|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability analysis|Ratio|92.37|STANDARD_DEVIATION|23.5||||90.0|90.079|94.719|||Geometric Mean||The Dispersion Value is actually the intraindividual gCV.|Estimated central measurements are compared to HPLC-MS/MS measurements. The comparison was done for the 468 quantifiable measurements.||94.719|90.079|
70983870|NCT01570491|141476272|SUPERIORITY_OR_OTHER|||||||0.83|||||||Kruskal-Wallis|||"We hypothesized that real-time US guidance would result in a 20% lower number of attempts compared to the control group.~At the 0.05 level of significance with a power of 0.8, we will require a minimum of 20 patients per group, therefore we planned to recruit 40 patients in total."||||0.83
71037070|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||ANCOVA|||Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.||||0.96
70983871|NCT01570491|141476273|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
70983872|NCT01570491|141476274|SUPERIORITY|||||||0.09|||||||Kruskal-Wallis|||||||0.09
70983873|NCT01570491|141476275|SUPERIORITY|||||||0.06|||||||Kruskal-Wallis|||||||0.06
70983874|NCT01015443|141476284|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.032||||0.921|TWO_SIDED|95.0|0.552|1.931|||Adjusted log rank|||||1.931|0.552|0.921
70983875|NCT01515072|141476290|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.38|TWO_SIDED|95.0|-0.37|0.21||This is an unadjusted comparison. P value \< 0.05|t-test, 2 sided|Adjusted analyses for the RIPC effect are provided below.|0.08 less organs per donor in the RIPC group.|Sample Size and Power estimation: A sample size of at least 150 donors in each arm was estimated to provide 80% power to detect a difference of 0.44 of an organ recovered and 0.48 of an organ transplanted per donor. The difference criterion was chosen based on published results achieved with hormonal resuscitation in organ donors. 6 Pooled standard deviations (organs recovered: 1.35; organs transplanted: 1.5) from data of two OPOs were used.||0.21|-0.37|0.38
70983876|NCT01515072|141476291|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.7|TWO_SIDED|95.0|-0.33|0.26||This is an unadjusted analysis. P \< 0.05|t-test, 2 sided|Adjusted analyses are provided below.|0.03 less organs per donor in the RIPC group.|Sample Size A sample size of at least 150 donors in each arm was estimated to provide 80% power to detect a difference of 0.44 of an organ recovered and 0.48 of an organ transplanted per donor. The difference criterion was chosen based on published results achieved with hormonal resuscitation in organ donors. 6 Pooled standard deviations (organs recovered: 1.35; organs transplanted: 1.5) from data of two OPOs were used.||0.26|-0.33|0.70
70983877|NCT01515072|141476292|SUPERIORITY_OR_OTHER|||||||0.63||||||P\<0.05|Wilcoxon (Mann-Whitney)|This is an unadjusted comparison||||||0.63
70983878|NCT01515072|141476293|SUPERIORITY_OR_OTHER|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||||||0.86
71037071|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||ANCOVA|||Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.||||0.72
71037072|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||ANCOVA|||Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.||||0.12
70983879|NCT01515072|141476294|SUPERIORITY_OR_OTHER|||||||0.55||||||P\<0.05|Wilcoxon (Mann-Whitney)|This is an unadjusted comparison||||||0.55
70983880|NCT01515072|141476295|SUPERIORITY_OR_OTHER|||||||0.55||||||P\<0.05|Wilcoxon (Mann-Whitney)|This is an unadjusted comparison||||||0.55
70983881|NCT01515072|141476296|SUPERIORITY_OR_OTHER|||||||0.48||||||P\<0.05|Wilcoxon (Mann-Whitney)|This is an unadjusted comparison||||||0.48
70983882|NCT01515072|141476297|SUPERIORITY_OR_OTHER|||||||0.04||||||P\<0.05|Wilcoxon (Mann-Whitney)|This is an unadjusted comparison||||||0.04
70983883|NCT01515072|141476298|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.7||||0.53|TWO_SIDED|95.0|-10.1|19.5||P\<0.05|Regression, Linear|Final flow was modeled on RIPC and adjusted for donor stratum and duration of perfusion|Data shown above is the the adjusted mean difference in final flow in RIPC group|||19.5|-10.1|0.53
70983884|NCT01515072|141476299|SUPERIORITY_OR_OTHER|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
70983885|NCT01515072|141476300|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.07|TWO_SIDED|95.0|0.95|2.76||Adjusted analysis with recipient age as a continuous variable, sex, race as black versus not black, body mass index, diabetes, hypertension,antigen mismatches, donor age as a continuous variable and trial site.|Chi-squared|||||2.76|0.95|0.07
70983886|NCT01515072|141476300|SUPERIORITY_OR_OTHER|||||||0.36||||||Unadjusted analysis|Chi-squared|||||||0.36
71037073|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.043||95.0|||||ANCOVA|||Percent change at Month 12 in HDL2: P value was calculated using ANCOVA.||||0.043
70983887|NCT01515072|141476301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.006|TWO_SIDED|95.0|0.03|0.17|||Regression, Linear|Final resistance was modeled on RIPC and adjusted for donor stratum and duration of perfusion.|Data shown above is the adjusted mean difference in final resistance in the RIPC group.|||0.17|0.03|0.006
70983888|NCT01515072|141476302|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|This is an unadjusted comparison||||||0.50
70983889|NCT01515072|141476303|SUPERIORITY_OR_OTHER|||||||0.03|||||||Log Rank|This is an unadjusted comparison||||||0.03
70983890|NCT01515072|141476304|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.19||||0.01|TWO_SIDED|95.0|0.04|0.9|||Log Rank|Results of adjusted Cox proportional hazard analyses for six month death-censored kidney graft survival are shown below|The proportional hazard ratio favors RIPC group|||0.90|0.04|0.01
70983891|NCT01515072|141476305|SUPERIORITY_OR_OTHER|||||||0.37|||||||Log Rank|This is an unadjusted comparison||||||0.37
70983892|NCT00609128|141476306|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|ANOVA with preplanned comparisons was used to generate two tailed P values. Paired t tests were used to make appropriate post-ANOVA comparisons.||"tears were collected in season from eyes of allergic patients with or without olopatadine treatment, that is one eye was treated and the patients other eye was not.~Tears from each patient's eyes were pooled to provide enough volume."||||<0.05
70983893|NCT00923091|141476318|SUPERIORITY_OR_OTHER|||||||0.0071||95.0|||||ANCOVA|||||||0.0071
70983894|NCT00923091|141476318|SUPERIORITY_OR_OTHER|||||||0.0323||95.0|||||ANCOVA|||||||0.0323
70983895|NCT00923091|141476318|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||ANCOVA|||||||0.0080
70983896|NCT00923091|141476318|SUPERIORITY_OR_OTHER|||||||0.0071||95.0|||||ANCOVA|||||||0.0071
70983897|NCT00923091|141476318|SUPERIORITY_OR_OTHER|||||||0.0107||95.0|||||ANCOVA|||||||0.0107
70983898|NCT00923091|141476319|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|||||||0.0006
70983899|NCT00923091|141476319|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||ANCOVA|||||||0.0008
70983900|NCT00923091|141476319|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71037074|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||ANCOVA|||Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.||||0.53
70983901|NCT00923091|141476319|SUPERIORITY_OR_OTHER|||||||0.0034||95.0|||||ANCOVA|||||||0.0034
70983902|NCT00923091|141476319|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|||||||0.0006
70983903|NCT00923091|141476320|SUPERIORITY_OR_OTHER|||||||0.0295||95.0|||||Cochran-Mantel-Haenszel|||||||0.0295
70983904|NCT00923091|141476320|SUPERIORITY_OR_OTHER|||||||0.2529||95.0|||||Cochran-Mantel-Haenszel|||||||0.2529
70983905|NCT00923091|141476320|SUPERIORITY_OR_OTHER|||||||0.0037||95.0|||||Cochran-Mantel-Haenszel|||||||0.0037
70983906|NCT00923091|141476320|SUPERIORITY_OR_OTHER|||||||0.2033||95.0|||||Cochran-Mantel-Haenszel|||||||0.2033
70983907|NCT00923091|141476320|SUPERIORITY_OR_OTHER|||||||0.2529||95.0|||||Cochran-Mantel-Haenszel|||||||0.2529
70983908|NCT00923091|141476321|SUPERIORITY_OR_OTHER|||||||0.1135||95.0|||||ANCOVA|||||||0.1135
70983909|NCT00923091|141476322|SUPERIORITY_OR_OTHER|||||||0.2765||95.0|||||ANCOVA|||||||0.2765
71037075|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||ANCOVA|||Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.||||0.75
71037076|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.||||<0.001
71037077|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.||||<0.001
70983910|NCT00923091|141476323|SUPERIORITY_OR_OTHER|||||||0.4964||95.0|||||Cochran-Mantel-Haenszel|||||||0.4964
70983911|NCT00923091|141476324|SUPERIORITY_OR_OTHER|||||||0.1301||95.0|||||ANCOVA|||||||0.1301
70983912|NCT00923091|141476324|SUPERIORITY_OR_OTHER|||||||0.01301||95.0|||||ANCOVA|||||||0.01301
70983913|NCT00923091|141476325|SUPERIORITY_OR_OTHER|||||||0.0503||95.0|||||ANCOVA|||||||0.0503
70983914|NCT00467649|141476328|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||Fisher Exact|||||||0.0180
70983915|NCT01852344|141476354|SUPERIORITY|||||||0.159|||||||t-test, 2 sided|||||||0.159
70983916|NCT01852344|141476354|SUPERIORITY|||||||0.159|||||||t-test, 2 sided|||||||0.159
70983917|NCT01852344|141476355|SUPERIORITY|||||||0.236|||||||t-test, 2 sided|||||||0.236
70983918|NCT01852344|141476356|SUPERIORITY|||||||0.032|||||||t-test, 2 sided|||||||0.032
70983919|NCT04458857|141476396|OTHER||LS mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.44||0.021|TWO_SIDED|95.0|-1.9|-0.16|||ANCOVA|||||-0.16|-1.90|0.0210
70983920|NCT03368404|141476411|NON_INFERIORITY|A sample size of 33 evaluable patients per treatment group was calculated to provide at least 90% power to demonstrate non-inferiority of CBL-102 to Vismed Multi. Assumptions included a non-inferiority margin of 2 grades and a standard deviation of 2.5|Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-1.34|0.13|||||Treatment difference : CBL-102 - Vismed Multi|||0.13|-1.34|
70983921|NCT03368404|141476412|SUPERIORITY|||||||0.0592||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0592
70983922|NCT03368404|141476413|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||>0.05
70983923|NCT03368404|141476414|SUPERIORITY||||||>|0.05||||||Significance level 0.05|ANCOVA|Adjustment for baseline||||||>0.05
70983924|NCT03368404|141476415|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||>0.05
70983925|NCT03368404|141476416|SUPERIORITY|||||||0.0176||||||Significance level 0.05|ANCOVA|||Change from Baseline in Global Sum Score of Dry Eye Symptoms at Day 28 (Visit 4)||||0.0176
70983926|NCT03368404|141476416|SUPERIORITY|||||||0.001||||||Significance level 0.05|ANCOVA|Adjustment to baseline||Change from Baseline in Global Sum Score of Dry Eye Symptoms at Day 90 (Visit 5)||||0.0010
70983927|NCT03368404|141476417|SUPERIORITY|||||||0.0251||||||Significance level 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality of Life (OSD-QoL®) dimension:~Daily Activities"||||0.0251
70983928|NCT03368404|141476417|SUPERIORITY|||||||0.0015||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality of Life (OSD-QoL®) dimension:~Difficulties with work and handicap"||||0.0015
70983929|NCT03368404|141476417|SUPERIORITY|||||||0.2024||||||Significance level 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension:~Giving up makeup"||||0.2024
71037078|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.||||<0.001
70983930|NCT03368404|141476417|SUPERIORITY|||||||0.0421||||||Significance level 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension:~Acknowledgement of the Disease"||||0.0421
70983931|NCT03368404|141476417|SUPERIORITY|||||||0.3945||||||Significance level 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension:~Acceptance of the disease"||||0.3945
70983932|NCT03368404|141476417|SUPERIORITY|||||||0.0536||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension:~Fear for the Future"||||0.0536
70983933|NCT03368404|141476417|SUPERIORITY|||||||0.1998||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension:~Emotional well-being"||||0.1998
70983934|NCT03368404|141476417|SUPERIORITY|||||||0.0306||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality of Life (OSD-QoL®) questions:~Global Question"||||0.0306
70983935|NCT03368404|141476418|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||>0.05
70983936|NCT03368404|141476419|SUPERIORITY||||||>|0.05||||||Significance level 0.05|ANCOVA|Adjustment for baseline||||||>0.05
70983937|NCT03368404|141476420|SUPERIORITY|||||||0.0017||||||Significance level of 0.05|Wilcoxon (Mann-Whitney)|||||||0.0017
70983938|NCT01282814|141476462|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|115.85|||||TWO_SIDED|90.0|108.45|123.72|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||123.72|108.45|
70983939|NCT01282814|141476463|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|109.97|||||TWO_SIDED|90.0|103.68|116.63|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||116.63|103.68|
70983940|NCT01282814|141476464|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.46|||||TWO_SIDED|90.0|101.45|111.71|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||111.71|101.45|
70983941|NCT01524289|141476467|SUPERIORITY||Difference in Least Squares (LS) Means|-39.7|||<|0.001|TWO_SIDED|95.0|-45.7|-33.7|||Constrained Longitudinal Data Analysis|Between group comparison of percent change from baseline performed using Constrained Longitudinal Data Analysis (cLDA) model.||||-33.7|-45.7|<0.001
70983942|NCT01524289|141476468|OTHER|Pre-specified|Difference in Percentages|-2.1|||||TWO_SIDED|95.0|-11.5|8.4|||||||Miettinen and Nurminen|8.4|-11.5|
70983943|NCT01524289|141476469|OTHER|Pre-specified|Difference in Percentages|4.5|||||TWO_SIDED|95.0|-4.8|12.6|||||||Miettinen and Nurminen|12.6|-4.8|
70983944|NCT01524289|141476470|OTHER|Pre-specified|Difference in Percentages|-0.9|||||TWO_SIDED|95.0|-8.9|5.6|||||||Miettinen \& Nurminen|5.6|-8.9|
71037079|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.||||<0.001
71037080|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANCOVA|||Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.||||0.46
71037081|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||ANCOVA|||Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.||||0.64
71037082|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||ANCOVA|||Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.||||0.47
71037083|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||ANCOVA|||Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.||||0.75
71037084|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANCOVA|||Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.||||0.003
71037085|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.||||<0.001
71037086|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.||||<0.001
71037087|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.||||<0.001
71037088|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||ANCOVA|||Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.||||0.81
71037089|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||ANCOVA|||Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.||||0.98
71037090|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||ANCOVA|||Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.||||0.87
71037091|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||ANCOVA|||Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.||||0.40
71037092|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.||||0.001
71037093|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.||||<0.001
71037094|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.||||<0.001
71037095|NCT00205777|141581676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.||||<0.001
71037096|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANCOVA|||Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.||||0.85
70983945|NCT01524289|141476471|OTHER|Pre-specified|Difference in Percentages|1.0|||||TWO_SIDED|95.0|-5.5|6.1|||||||Miettinen and Nurminen|6.1|-5.5|
70983946|NCT01524289|141476472|OTHER|Pre-Specified|Difference in Percentages|-8.4||||0.168|TWO_SIDED|95.0|-20.1|3.5|||Miettinen and Nurminen|||||3.5|-20.1|0.168
70983947|NCT01524289|141476473|OTHER|Pre-specified|Difference in Percentages|-7.4||||0.179|TWO_SIDED|95.0|-18.7|3.3|||Miettinen and Nurminen|||||3.3|-18.7|0.179
70983948|NCT01524289|141476474|OTHER|Pre-specified|Difference in Percentages|-13.9||||0.011|TWO_SIDED|95.0|-25.0|-3.1|||Miettinen and Nurminen|||||-3.1|-25.0|0.011
70983949|NCT01524289|141476475|OTHER|Pre-specified|Difference in Percentages|1.5||||0.696|TWO_SIDED|95.0|-6.8|8.4|||Miettinen and Nurminen|||||8.4|-6.8|0.696
70983950|NCT01524289|141476476|OTHER|Pre-specified|Difference in Percentages|0.5||||0.48|TWO_SIDED|95.0|-3.2|2.8|||Miettinen and Nurminen|||||2.8|-3.2|0.480
70983951|NCT01524289|141476477|OTHER|Pre-specified|Difference in Percentages|0.5||||0.722|TWO_SIDED|95.0|-4.0|3.5|||Miettinen and Nurminen|||||3.5|-4.0|0.722
70983952|NCT01524289|141476478|OTHER|Pre-specified|Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-3.7|1.9|||Miettinen and Nurminen|||||1.9|-3.7|>0.999
70983953|NCT01524289|141476479|OTHER|Pre-specified|Difference in Percentages|0.5||||0.722|TWO_SIDED|95.0|-4.0|3.5|||Miettinen and Nurminen|||||3.5|-4.0|0.722
70983954|NCT01524289|141476480|OTHER|Pre-specified|Difference in Percentages|-1.0||||0.157|TWO_SIDED|95.0|-5.4|0.9|||Miettinen and Nurminen|||||0.9|-5.4|0.157
70983955|NCT01524289|141476481|OTHER|Pre-specified|Difference in Percentages|-1.0||||0.157|TWO_SIDED|95.0|-5.4|0.9|||Miettinen and Nurminen|||||0.9|-5.4|0.157
71037097|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||ANCOVA|||Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.||||0.26
71037098|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||ANCOVA|||Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.||||0.33
71097603|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|3.11|||||TWO_SIDED|95.0|2.23|4.33||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.33|2.23|
71097604|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|0.84|||||TWO_SIDED|95.0|0.61|1.17||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.17|0.61|
70983956|NCT01524289|141476482|OTHER|Pre-specified|Difference in Percentages|1.5||||0.218|TWO_SIDED|95.0|-2.2|4.3|||Miettinen and Nurminen|||||4.3|-2.2|0.218
70983957|NCT01524289|141476483|OTHER|Pre-specified|Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-3.6|1.9|||Miettinen and Nurminen|||||1.9|-3.6|>0.999
71037099|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANCOVA|||Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.||||0.22
71097605|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|0.27|||||TWO_SIDED|95.0|0.19|0.4||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.40|0.19|
70983958|NCT01524289|141476484|SUPERIORITY||Difference in Least Squares (LS) Means|102.1|||<|0.001|TWO_SIDED|95.0|94.2|110.1|||Constrained Longitudinal Data Analysis|||||110.1|94.2|<0.001
70983959|NCT01524289|141476485|SUPERIORITY||Difference in LS Means|-36.4|||<|0.001|TWO_SIDED|95.0|-41.7|-31.1|||Constrained Longitudinal Data Analysis|||||-31.1|-41.7|<0.001
70983960|NCT01524289|141476486|SUPERIORITY||Difference in LS Means|-24.8|||<|0.001|TWO_SIDED|95.0|-29.5|-20.1|||Constrained Longitudinal Data Analysis|||||-20.1|-29.5|<0.001
70983961|NCT01524289|141476487|SUPERIORITY||Difference in LS Means|32.9|||<|0.001|TWO_SIDED|95.0|28.2|37.6|||Constrained Longitudinal Data Analysis|||||37.6|28.2|<0.001
70983962|NCT01524289|141476488|SUPERIORITY||Median Difference (Final Values)|-27.9|||<|0.001|TWO_SIDED|95.0|-34.7|-21.2|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimate of the median difference between treatments with a corresponding distribution-free confidence interval (CI) based on Wilcoxon's rank sum test.|||-21.2|-34.7|<0.001
70983963|NCT02104180|141476489|NON_INFERIORITY|An estimate of the difference between the pain felt by patient during the two dressings removals along with a 95% confidence interval (CI) has been derived. If the upper limit of the confidence interval was less than 13 mm, clinical non-inferiority of Tulle Gras versus Urgotul has been demonstrated.|Mean Difference (Final Values)|0.26|||||TWO_SIDED|95.0|-1.339|1.864|||||The pain intensity has been analyzed using analysis of variance (ANOVA). The model for this cross-over study included sequence, period and treatment as fixed effects and subject within sequence as random effect.|||1.864|-1.339|
70983964|NCT02495077|141476529|SUPERIORITY||Mean Difference (Final Values)|-4.9||||0.099|TWO_SIDED|95.0|-10.73|0.93|||Mixed Models Analysis|||Mean eGFR of the two treatment groups was compared. The p-value, estimated month 24 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence intervals result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group. Random effects for the intercept and eGFR collection day were utilized in the model.||0.93|-10.73|0.099
70983965|NCT02495077|141476530|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
70983966|NCT02495077|141476531|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
70983967|NCT02495077|141476533|SUPERIORITY|||||||0.746|||||||Fisher Exact|||||||0.746
70983968|NCT02495077|141476534|SUPERIORITY|||||||0.242|||||||Chi-squared|||||||0.242
70983969|NCT02495077|141476536|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
70983970|NCT02495077|141476537|SUPERIORITY|||||||0.497|||||||Fisher Exact|||||||0.497
70983971|NCT02495077|141476538|SUPERIORITY|||||||0.622|||||||Fisher Exact|||||||0.622
71037100|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||ANCOVA|||Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.||||0.86
71037101|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||ANCOVA|||Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.||||0.65
71037102|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||1||95.0|||||ANCOVA|||Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.||||1.00
70983972|NCT02495077|141476540|SUPERIORITY|||||||0.011|||||||Chi-squared|||||||0.011
70983973|NCT02495077|141476541|SUPERIORITY|||||||0.135|||||||Cochran-Mantel-Haenszel|||||||0.135
70983974|NCT02495077|141476542|SUPERIORITY|||||||0.157|||||||Chi-squared|||||||0.157
70983975|NCT02495077|141476543|SUPERIORITY|||||||0.071|||||||Chi-squared|||||||0.071
71037103|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||ANCOVA|||Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.||||0.44
71037104|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||ANCOVA|||Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.||||0.058
71037105|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||ANCOVA|||Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.||||0.55
71037106|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||ANCOVA|||Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.||||0.34
71037107|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||ANCOVA|||Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.||||0.96
71037108|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||ANCOVA|||Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.||||0.058
71097606|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratrio|1.82|||||TWO_SIDED|95.0|1.25|2.66||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.66|1.25|
70983976|NCT02495077|141476544|SUPERIORITY|||||||0.543|||||||t-test, 2 sided|||||||0.543
71097607|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|1.33|||||TWO_SIDED|95.0|0.91|1.94||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.94|0.91|
70983977|NCT02495077|141476545|SUPERIORITY|||||||0.617|||||||t-test, 2 sided|||||||0.617
70983978|NCT02495077|141476546|SUPERIORITY|||||||0.275|||||||t-test, 2 sided|||||||0.275
70983979|NCT02495077|141476547|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.300
70983980|NCT02495077|141476548|SUPERIORITY|||||||0.152|||||||t-test, 2 sided|||||||0.152
70983981|NCT02495077|141476549|SUPERIORITY|||||||0.181|||||||t-test, 2 sided|||||||0.181
71037109|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||ANCOVA|||Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.||||0.031
70983982|NCT02495077|141476550|SUPERIORITY||Mean Difference (Final Values)|-1.03||||0.639|TWO_SIDED|95.0|-5.37|3.3|||Mixed Models Analysis|||Day 7. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 7 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from day 7 and months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 7. Random effects for the intercept and eGFR collection day were utilized in the model.||3.30|-5.37|0.639
70983983|NCT02495077|141476551|SUPERIORITY||Mean Difference (Final Values)|-1.56||||0.51|TWO_SIDED|95.0|-6.22|3.1|||Mixed Models Analysis|||Day 30. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 30 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 30. Random effects for the intercept and eGFR collection day were utilized in the model.||3.10|-6.22|0.510
70983984|NCT02495077|141476551|SUPERIORITY||Mean Difference (Final Values)|-1.85||||0.43|TWO_SIDED|95.0|-6.45|2.76|||Mixed Models Analysis|||Day 90. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 90 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 90. Random effects for the intercept and eGFR collection day were utilized in the model.||2.76|-6.45|0.430
71037110|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.054||95.0|||||ANCOVA|||Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.||||0.054
71037111|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||ANCOVA|||Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.||||0.62
71037112|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||ANCOVA|||Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.||||0.99
71037113|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANCOVA|||Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.||||0.11
71037114|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||ANCOVA|||Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.||||0.33
71037115|NCT00205777|141581676|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||ANCOVA|||Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.||||0.65
71037116|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.97|||||||ANOVA|||BV: P value was calculated using Analysis of Variance (ANOVA).||||0.97
71037117|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||ANOVA|||BV: P value was calculated using ANOVA.||||0.19
71037118|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||ANOVA|||BV: P value was calculated using ANOVA.||||0.74
71037119|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||ANOVA|||BV: P value was calculated using ANOVA.||||0.79
71037120|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.11|||||||ANOVA|||BV: P value was calculated using ANOVA.||||0.11
71037121|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.78|||||||ANOVA|||OV: P value was calculated using ANOVA.||||0.78
71037122|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||OV: P value was calculated using ANOVA.||||0.90
71037123|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.33|||||||ANOVA|||OV: P value was calculated using ANOVA.||||0.33
71037124|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.51|||||||ANOVA|||OV: P value was calculated using ANOVA.||||0.51
71037125|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.28|||||||ANOVA|||OV: P value was calculated using ANOVA.||||0.28
71037126|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.86|||||||ANOVA|||OS: P value was calculated using ANOVA.||||0.86
71037127|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.6|||||||ANOVA|||OS: P value was calculated using ANOVA.||||0.60
71037128|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.84|||||||ANOVA|||OS: P value was calculated using ANOVA.||||0.84
71037129|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.98|||||||ANOVA|||OS: P value was calculated using ANOVA.||||0.98
71037130|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.47|||||||ANOVA|||OS: P value was calculated using ANOVA.||||0.47
71037131|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.59|||||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.59
71037132|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.13|||||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.13
71037133|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.65|||||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.65
71037134|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.33|||||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.33
71037135|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.053|||||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.053
71037136|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.51|||||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.51
71037137|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.5|||||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.50
71037138|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.27|||||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.27
71037139|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.091|||||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.091
71037140|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.087|||||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.087
71037141|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.82|||||||ANOVA|||MS: P value was calculated using ANOVA.||||0.82
71037142|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.82|||||||ANOVA|||MS: P value was calculated using ANOVA.||||0.82
71037143|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.12|||||||ANOVA|||MS: P value was calculated using ANOVA.||||0.12
71037144|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.085|||||||ANOVA|||MS: P value was calculated using ANOVA.||||0.085
71037145|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.08|||||||ANOVA|||MS: P value was calculated using ANOVA.||||0.080
71037146|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.24|||||||ANOVA|||ES: P value was calculated using ANOVA.||||0.24
71037147|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.035|||||||ANOVA|||ES: P value was calculated using ANOVA.||||0.035
71037148|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.024|||||||ANOVA|||ES: P value was calculated using ANOVA.||||0.024
71037149|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.3|||||||ANOVA|||ES: P value was calculated using ANOVA.||||0.30
71037150|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.89|||||||ANOVA|||ES: P value was calculated using ANOVA.||||0.89
71037151|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.8|||||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.80
71037152|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.75|||||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.75
71037153|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.060
71037154|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.12|||||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.12
71037155|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.13|||||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.13
71037156|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.78|||||||ANOVA|||CP: P value was calculated using ANOVA.||||0.78
71037157|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.7|||||||ANOVA|||CP: P value was calculated using ANOVA.||||0.70
71037158|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.98|||||||ANOVA|||CP: P value was calculated using ANOVA.||||0.98
71037159|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|||CP: P value was calculated using ANOVA.||||0.76
71037160|NCT00205777|141581677|SUPERIORITY_OR_OTHER|||||||0.73|||||||ANOVA|||CP: P value was calculated using ANOVA.||||0.73
71037161|NCT00205777|141581678|SUPERIORITY_OR_OTHER|||||||0.7|||||||ANOVA|||BV: P value was calculated using ANOVA.||||0.70
71037162|NCT00205777|141581678|SUPERIORITY_OR_OTHER|||||||0.65|||||||ANOVA|||BV: P value was calculated using ANOVA.||||0.65
71037163|NCT00205777|141581678|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA|||OV: P value was calculated using ANOVA.||||0.006
71037164|NCT00205777|141581678|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|||OV: P value was calculated using ANOVA.||||0.010
71037165|NCT00205777|141581678|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||OS: P value was calculated using ANOVA.||||0.050
71037166|NCT00205777|141581678|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||ANOVA|||OS: P value was calculated using ANOVA.||||0.045
71037167|NCT00205777|141581678|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.18
71037168|NCT00205777|141581678|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.56
71037169|NCT00205777|141581678|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.14
71037170|NCT00205777|141581678|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.22
71037171|NCT00205777|141581678|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANOVA|||MS: P value was calculated using ANOVA.||||0.11
71037172|NCT00205777|141581678|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||ANOVA|||MS: P value was calculated using ANOVA.||||0.055
71037173|NCT00205777|141581678|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||ANOVA|||ES: P value was calculated using ANOVA.||||0.069
71037174|NCT00205777|141581678|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||ANOVA|||ES: P value was calculated using ANOVA.||||0.28
71037175|NCT00205777|141581678|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.62
71037176|NCT00205777|141581678|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.96
71037177|NCT00205777|141581679|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||ANOVA|||WTh: P value was calculated using ANOVA.||||0.22
71037178|NCT00205777|141581679|SUPERIORITY_OR_OTHER|||||||0.087|TWO_SIDED||||||ANOVA|||WTh: p-value was calculated using ANOVA.||||0.087
71037179|NCT00205777|141581679|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||ANOVA|||WTh: p-value was calculated using ANOVA.||||0.37
71037180|NCT00205777|141581679|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||ANOVA|||WTh: p-value was calculated using ANOVA.||||0.73
70983985|NCT02495077|141476551|SUPERIORITY||Mean Difference (Final Values)|-2.28||||0.328|TWO_SIDED|95.0|-6.86|2.31|||Mixed Models Analysis|||Day 180. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 180 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 180. Random effects for the intercept and eGFR collection day were utilized in the model.||2.31|-6.86|0.328
70983986|NCT02495077|141476552|SUPERIORITY||Mean Difference (Final Values)|-0.85||||0.725|TWO_SIDED|95.0|-5.58|3.89|||Mixed Models Analysis|||Day 7. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 7 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from day 7 and months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 7. Random effects for the intercept and eGFR collection day were utilized in the model.||3.89|-5.58|0.725
70983987|NCT02495077|141476553|SUPERIORITY||Mean Difference (Final Values)|-1.35||||0.601|TWO_SIDED|95.0|-6.41|3.72|||Mixed Models Analysis|||Day 30. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 30 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 30. Random effects for the intercept and eGFR collection day were utilized in the model.||3.72|-6.41|0.601
70983988|NCT02495077|141476553|SUPERIORITY||Mean Difference (Final Values)|-1.64||||0.519|TWO_SIDED|95.0|-6.66|3.37|||Mixed Models Analysis|||Day 90. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 90 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 90. Random effects for the intercept and eGFR collection day were utilized in the model.||3.37|-6.66|0.519
70983989|NCT02495077|141476553|SUPERIORITY||Mean Difference (Final Values)|-2.09||||0.411|TWO_SIDED|95.0|-7.08|2.91|||Mixed Models Analysis|||Day 180. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 180 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 180. Random effects for the intercept and eGFR collection day were utilized in the model.||2.91|-7.08|0.411
70983990|NCT02495077|141476554|SUPERIORITY|||||||0.569|||||||Chi-squared|||||||0.569
70983991|NCT02495077|141476555|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
70983992|NCT02495077|141476556|SUPERIORITY|||||||0.451|||||||Chi-squared|||||||0.451
70983993|NCT02495077|141476557|SUPERIORITY|||||||0.614|||||||t-test, 2 sided|||||||0.614
70983994|NCT02495077|141476558|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||||||0.710
70983995|NCT02495077|141476559|SUPERIORITY|||||||0.622|||||||Fisher Exact|||||||0.622
70983996|NCT02495077|141476560|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.256|TWO_SIDED|95.0|-0.36|1.35|||Mixed Models Analysis|||24 Hours/Day 1. Mean serum creatinine of the two treatment groups was compared. The p-value, estimated 24 hour creatinine level within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available serum creatinine data from 24, 48, and 72 hours to compare the experimental group to the control group at 24 hours/day 1. A random effect for the intercept was utilized in the model.||1.35|-0.36|0.256
70983997|NCT02495077|141476560|SUPERIORITY||Mean Difference (Final Values)|0.37||||0.391|TWO_SIDED|95.0|-0.48|1.23|||Mixed Models Analysis|||48 Hours/Day 2. Mean serum creatinine of the two treatment groups was compared. The p-value, estimated 48 hour creatinine level within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available serum creatinine data from 24, 48, and 72 hours to compare the experimental group to the control group at 48 hours/day 2. A random effect for the intercept was utilized in the model.||1.23|-0.48|0.391
70983998|NCT02495077|141476560|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.199|TWO_SIDED|95.0|-0.3|1.42|||Mixed Models Analysis|||72 Hours/Day 3. Mean serum creatinine of the two treatment groups was compared. The p-value, estimated 72 hour creatinine level within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available serum creatinine data from 24, 48, and 72 hours to compare the experimental group to the control group at 72 hours/day 3. A random effect for the intercept was utilized in the model.||1.42|-0.30|0.199
71037181|NCT00205777|141581679|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||ANOVA|||WTh: p-value was calculated using ANOVA.||||0.41
70983999|NCT02495077|141476561|SUPERIORITY|||||||0.812|||||||Log Rank|||||||0.812
70984000|NCT02495077|141476562|SUPERIORITY|||||||0.576|||||||Chi-squared|||||||0.576
70984001|NCT02495077|141476563|SUPERIORITY|||||||0.311|||||||t-test, 2 sided|||||||0.311
70984002|NCT02495077|141476564|SUPERIORITY|||||||0.418|||||||t-test, 2 sided|||||||0.418
70984003|NCT02495077|141476565|SUPERIORITY|||||||0.03|||||||Chi-squared|||||||0.030
70984004|NCT02495077|141476566|SUPERIORITY|||||||0.153|||||||Chi-squared|||||||0.153
70984005|NCT02495077|141476567|SUPERIORITY|||||||0.171|||||||Fisher Exact|||||||0.171
70984006|NCT02495077|141476568|SUPERIORITY|||||||0.163|||||||Chi-squared|||||||0.163
70984007|NCT02495077|141476569|SUPERIORITY|||||||0.572|||||||Chi-squared|||||||0.572
70984008|NCT02495077|141476570|SUPERIORITY|||||||0.973|||||||Chi-squared|||||||0.973
70984009|NCT02495077|141476571|SUPERIORITY|||||||0.152|||||||Chi-squared|||||||0.152
70984010|NCT02495077|141476572|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
70984011|NCT02495077|141476573|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
70984012|NCT02495077|141476574|SUPERIORITY|||||||0.347|||||||Chi-squared|||||||0.347
71037182|NCT00205777|141581679|SUPERIORITY_OR_OTHER|||||||0.085||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.085
71037183|NCT00205777|141581679|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.15
71037184|NCT00205777|141581679|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.71
70984013|NCT03726671|141476575|OTHER|||||||0.0247|||||||Repeated measures ANOVA|||Betaine IER||||0.0247
70984014|NCT03726671|141476575|OTHER||||||<|0.0001|||||||Repeated measures ANOVA|||Choline IER||||<0.0001
70984015|NCT03726671|141476575|OTHER|||||||0.0002|||||||Repeated measures ANOVA|||Phosphatidylcholine IER||||0.0002
70984016|NCT03726671|141476576|OTHER||Odds Ratio (OR)|7.16|||<|0.001|TWO_SIDED|95.0|3.48|14.7|||Fisher Exact|||||14.7|3.48|<0.001
70984017|NCT03726671|141476576|OTHER||Odds Ratio (OR)|4.09||||0.01|TWO_SIDED|95.0|2.06|8.11|||Fisher Exact|||||8.11|2.06|0.01
70984018|NCT03726671|141476576|OTHER||Odds Ratio (OR)|1.75||||0.086|TWO_SIDED|95.0|0.86|3.58|||Fisher Exact|||||3.58|0.86|0.086
70984019|NCT03726671|141476577|OTHER|||||||0.6985|||||||t-test, 2 sided|||Betaine IER||||0.6985
70984020|NCT03726671|141476577|OTHER|||||||0.035|||||||t-test, 2 sided|||Choline IER||||0.0350
70984021|NCT03726671|141476577|OTHER|||||||0.6864|||||||t-test, 2 sided|||Phosphatidylcholine IER||||0.6864
70984022|NCT03726671|141476578|EQUIVALENCE|There are linear combinations of metabolites that differentiate (non-equivalent) the 25% choline diet from the 100% choline diet.|||||<|0.049|||||||Paired 2-sided t-test||||Supervised OPLSDA was used to determine the variable importance to projections of metabolites/signals that differentiated the 25% and 100% choline diet arms.|||<0.049
71037185|NCT00205777|141581679|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.042
71097608|NCT01026038|141703959|SUPERIORITY_OR_OTHER||GMC ratio|0.73|||||TWO_SIDED|95.0|0.47|1.13||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.13|0.47|
70984023|NCT03726671|141476579|OTHER|||||||0.9567|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Betaine IER in Pre-Menopausal Females||||0.9567
70984024|NCT03726671|141476579|OTHER|||||||0.0899|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Betaine IER in Post-Menopausal Females||||0.0899
70984025|NCT03726671|141476579|OTHER|||||||0.9003|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Betaine IER in Males||||0.9003
71097609|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|0.63|||||TWO_SIDED|95.0|0.23|1.76||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.76|0.23|
70984026|NCT03726671|141476579|OTHER|||||||0.9932|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Choline IER in Pre-Menopausal Females||||0.9932
70984027|NCT03726671|141476579|OTHER|||||||0.3984|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Choline IER in Post-Menopausal Females||||0.3984
70984028|NCT03726671|141476579|OTHER|||||||0.308|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Choline IER in Males||||0.3080
70984029|NCT03726671|141476579|OTHER|||||||0.7603|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Phosphatidylcholine IER in Pre-Menopausal Females||||0.7603
70984030|NCT03726671|141476579|OTHER|||||||0.2995|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Phosphatidylcholine IER in Post-Menopausal Females||||0.2995
70984031|NCT03726671|141476579|OTHER|||||||0.0003|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Phosphatidylcholine IER in Males||||0.0003
70984032|NCT03726671|141476579|OTHER|||||||0.1303|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Betaine IER in Pre-Menopausal Females||||0.1303
70984033|NCT03726671|141476579|OTHER|||||||0.0015|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Betaine IER in Post-Menopausal Females||||0.0015
70984034|NCT03726671|141476579|OTHER|||||||0.4185|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Betaine IER in Males||||0.4185
70984035|NCT03726671|141476579|OTHER|||||||0.3464|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Choline IER in Pre-Menopausal Females||||0.3464
70984036|NCT03726671|141476579|OTHER|||||||0.0019|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Choline IER in Post-Menopausal Females||||0.0019
70984037|NCT03726671|141476579|OTHER|||||||0.2091|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Choline IER in Males||||0.2091
71037186|NCT00205777|141581679|SUPERIORITY_OR_OTHER|||||||0.077||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.077
71037187|NCT00205777|141581679|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.35
71037188|NCT00205777|141581679|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.12
71037189|NCT00205777|141581679|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.41
70984038|NCT03726671|141476579|OTHER|||||||0.8141|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Phosphatidylcholine IER in Pre-Menopausal Females||||0.8141
70984039|NCT03726671|141476579|OTHER|||||||0.0187|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Phosphatidylcholine IER in Post-Menopausal Females||||0.0187
70984040|NCT03726671|141476579|OTHER|||||||0.0107|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Phosphatidylcholine IER in Males||||0.0107
70984041|NCT03726671|141476580|OTHER|||||||0.0842|||||||Mixed Models Analysis|||||||0.0842
71037190|NCT00205777|141581679|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.90
71037191|NCT00205777|141581679|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.46
71037192|NCT00205777|141581679|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.18
71037193|NCT00205777|141581679|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.75
71037194|NCT00205777|141581679|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.10
70984042|NCT03726671|141476580|OTHER|||||||0.0819|||||||Wilcoxon (Mann-Whitney)|Non-parametric method was used due to data deviation from normality.||||||0.0819
71037195|NCT00205777|141581679|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.79
71037196|NCT00205777|141581679|SUPERIORITY_OR_OTHER|||||||0.057||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.057
70984043|NCT03726671|141476580|OTHER|||||||0.9015|||||||t-test, 2 sided|||||||0.9015
71037197|NCT00205777|141581679|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||ANOVA|||CTh: P value was calculated using ANOVA.||||0.17
71037198|NCT00205777|141581679|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANOVA|||CTh: P value was calculated using ANOVA.||||0.46
71037199|NCT00205777|141581679|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||ANOVA|||CTh: P value was calculated using ANOVA.||||0.83
71037200|NCT00205777|141581679|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||ANOVA|||CTh: P value was calculated using ANOVA.||||0.25
70984044|NCT03726671|141476580|OTHER|||||||0.1191|||||||Wilcoxon (Mann-Whitney)|Non-parametric method was used due to data deviation from normality.||||||0.1191
70984045|NCT03726671|141476581|OTHER|||||||0.2351|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. betaine IER||||0.2351
70984046|NCT03726671|141476581|OTHER|||||||0.4501|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Phosphatidylcholine IER||||0.4501
70984047|NCT03726671|141476581|OTHER|||||||0.4136|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Choline IER||||0.4136
70984048|NCT03726671|141476581|OTHER|||||||0.9463|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Betaine IER||||0.9463
70984049|NCT03726671|141476581|OTHER|||||||0.0675|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Phosphatidylcholine IER||||0.0675
70984050|NCT03726671|141476581|OTHER|||||||0.2863|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Choline IER||||0.2863
70984051|NCT03726671|141476581|OTHER|||||||0.5552|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Betaine IER||||0.5552
70984052|NCT03726671|141476581|OTHER|||||||0.4209|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Phosphatidylcholine IER||||0.4209
70984053|NCT03726671|141476581|OTHER|||||||0.6647|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Choline IER||||0.6647
71037201|NCT00205777|141581679|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANOVA|||CTh: P value was calculated using ANOVA.||||0.35
71037202|NCT00205777|141581680|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||ANOVA|||WTh: P value was calculated using ANOVA.||||0.018
71037203|NCT00205777|141581680|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||ANOVA|||WTh: P value was calculated using ANOVA.||||0.29
71037204|NCT00205777|141581680|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.049
71037205|NCT00205777|141581680|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.37
71037206|NCT00205777|141581680|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.97
71037207|NCT00205777|141581680|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.78
71037208|NCT00205777|141581680|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.43
71037209|NCT00205777|141581680|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.32
71037210|NCT00205777|141581681|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||ANOVA|||||||0.35
71037211|NCT00205777|141581681|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||ANOVA|||||||0.66
71037212|NCT00205777|141581681|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||ANOVA|||||||0.30
71037213|NCT00205777|141581681|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||ANOVA|||||||0.95
71037214|NCT00205777|141581681|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||ANOVA|||||||0.15
71037215|NCT00205777|141581682|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||ANOVA|||||||1.00
71037216|NCT00205777|141581682|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||ANOVA|||||||0.40
71037217|NCT00205777|141581683|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||ANOVA|||||||0.71
71037218|NCT00205777|141581683|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||ANOVA|||||||0.83
71037219|NCT00205777|141581683|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||ANOVA|||||||0.63
71037220|NCT00205777|141581683|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||ANOVA|||||||0.92
71037221|NCT00205777|141581683|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||ANOVA|||||||0.50
71037222|NCT00205777|141581684|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||ANOVA|||||||0.73
71037223|NCT00205777|141581684|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||ANOVA|||||||0.80
71037224|NCT00205777|141581685|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.81
71037225|NCT00205777|141581685|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.96
71037226|NCT00205777|141581685|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.005
71037227|NCT00205777|141581685|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.013
71037228|NCT00205777|141581685|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.006
71037229|NCT00205777|141581685|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||0.70
71037230|NCT00205777|141581685|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||0.44
71037231|NCT00205777|141581685|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||0.47
71037232|NCT00205777|141581685|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||0.28
71037233|NCT00205777|141581685|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||0.14
71037234|NCT00205777|141581685|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.93
71037235|NCT00205777|141581685|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.85
71037236|NCT00205777|141581685|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.010
71037237|NCT00205777|141581685|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.015
71037238|NCT00205777|141581685|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.006
71037239|NCT00205777|141581686|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.60
71037240|NCT00205777|141581686|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.53
71037241|NCT00205777|141581686|SUPERIORITY_OR_OTHER|||||||1||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||1.00
71037242|NCT00205777|141581686|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||0.43
71037243|NCT00205777|141581686|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.60
71037244|NCT00205777|141581686|SUPERIORITY_OR_OTHER|||||||0.52||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.52
71037245|NCT00205777|141581687|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||ANOVA|||||||0.22
71037246|NCT00205777|141581687|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|||||||0.76
71037247|NCT00205777|141581687|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||ANOVA|||||||0.26
71037248|NCT00205777|141581687|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||ANOVA|||||||0.90
71037249|NCT00205777|141581687|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||||||0.16
71037250|NCT00205777|141581688|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||ANOVA|||||||0.41
71037251|NCT00205777|141581688|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||||||0.18
71037252|NCT00205777|141581689|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||ANOVA|||||||0.68
71037253|NCT00205777|141581689|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||ANOVA|||||||0.97
71037254|NCT00205777|141581689|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||||||0.18
71037255|NCT00205777|141581689|SUPERIORITY_OR_OTHER|||||||0.088||95.0|||||ANOVA|||||||0.088
71037256|NCT00205777|141581689|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||ANOVA|||||||0.17
71037257|NCT00205777|141581690|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||ANOVA|||||||0.25
71037258|NCT00205777|141581690|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||ANOVA|||||||0.10
71037259|NCT00205777|141581691|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||ANOVA|||||||0.90
71037260|NCT00205777|141581691|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||ANOVA|||||||0.74
71037261|NCT00205777|141581691|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||ANOVA|||||||0.13
71037262|NCT00205777|141581691|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANOVA|||||||0.11
71037263|NCT00205777|141581691|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||ANOVA|||||||0.24
71037264|NCT00205777|141581692|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||ANOVA|||||||0.25
71037265|NCT00205777|141581692|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||ANOVA|||||||0.070
71037266|NCT00205777|141581693|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||ANOVA|||||||0.77
71037267|NCT00205777|141581693|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||ANOVA|||||||0.91
71037268|NCT00205777|141581693|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANOVA|||||||0.009
71037269|NCT00205777|141581693|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANOVA|||||||0.023
71037270|NCT00205777|141581693|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||ANOVA|||||||0.012
71037271|NCT00205777|141581694|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||ANOVA|||||||0.79
71037272|NCT00205777|141581694|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||ANOVA|||||||0.61
71037273|NCT00205777|141581695|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||ANOVA|||||||0.30
71037274|NCT00205777|141581695|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||ANOVA|||||||0.62
71037275|NCT00205777|141581695|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||ANOVA|||||||0.28
71037276|NCT00205777|141581695|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||ANOVA|||||||0.041
71037277|NCT00205777|141581695|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||ANOVA|||||||0.12
71037278|NCT00205777|141581696|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||ANOVA|||||||0.70
71037279|NCT00205777|141581696|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||ANOVA|||||||0.61
71037280|NCT00205777|141581697|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||ANOVA|||||||0.22
71037281|NCT00205777|141581697|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|||||||0.76
71037282|NCT00205777|141581697|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||ANOVA|||||||0.26
71037283|NCT00205777|141581697|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||ANOVA|||||||0.89
70984054|NCT01709799|141476590|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,90.577)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)||||< .001
70984055|NCT01709799|141476590|SUPERIORITY_OR_OTHER|||||||0.995|TWO_SIDED|||||The p-value is not adjusted for multiple comparisons, and the a priori threshold for statistical significance was 0.05|Mixed Models Analysis|Degrees of freedom are (4,90.564)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)||||0.995
70984056|NCT01709799|141476591|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,97.137)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)||||<.001
70984057|NCT01709799|141476591|SUPERIORITY_OR_OTHER|||||||0.254|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (4,97.108)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)||||0.254
70984058|NCT01709799|141476592|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,99.647)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)||||<0.001
70984059|NCT01709799|141476592|SUPERIORITY_OR_OTHER|||||||0.781|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (4,99.601)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)||||0.781
70984060|NCT01709799|141476593|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,102.315)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)||||<0.001
70984061|NCT01709799|141476593|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (4,102.216)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)||||0.026
70984062|NCT01709799|141476594|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,93.240)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)||||<0.001
70984063|NCT01709799|141476594|SUPERIORITY_OR_OTHER|||||||0.313|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (4,93.167)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)||||0.313
70984064|NCT01709799|141476595|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,115.573)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)||||0.630
70984065|NCT01709799|141476595|SUPERIORITY_OR_OTHER|||||||0.498|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (4,115.593)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)||||0.498
70984066|NCT00435539|141476596|SUPERIORITY_OR_OTHER|||||||0.4783|||||||Fisher Exact|||||||0.4783
70984067|NCT00435539|141476596|SUPERIORITY_OR_OTHER|||||||0.0932|||||||Fisher Exact|||||||0.0932
70984068|NCT00435539|141476596|SUPERIORITY_OR_OTHER|||||||0.0721|||||||Fisher Exact|||||||0.0721
70984069|NCT00435539|141476597|SUPERIORITY_OR_OTHER|||||||0.4762|||||||Fisher Exact|||||||0.4762
70984070|NCT00435539|141476597|SUPERIORITY_OR_OTHER|||||||0.4762|||||||Fisher Exact|||||||0.4762
70984071|NCT00435539|141476597|SUPERIORITY_OR_OTHER|||||||0.5343|||||||Fisher Exact|||||||0.5343
70984072|NCT01508676|141476796|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||.04
70984073|NCT02532543|141476799|SUPERIORITY|||||||0.863|||||||ANOVA|||||||0.863
70984074|NCT02532543|141476800|SUPERIORITY|||||||0.718|||||||ANOVA|||Comparison between each arm/group at 2 mm from the height of the bone crest||||0.718
70984075|NCT02532543|141476800|SUPERIORITY|||||||0.853|||||||ANOVA|||Comparison between each arm/group at 4 mm from the height of the bone crest||||0.853
70984076|NCT02532543|141476801|SUPERIORITY|||||||0.718|||||||ANOVA|||Comparison between each arm/group of change in mid buccal bone height||||0.718
70984077|NCT02532543|141476801|SUPERIORITY|||||||0.999|||||||ANOVA|||Comparison between each arm/group of change in mid palatal bone height||||0.999
70984078|NCT02532543|141476801|SUPERIORITY|||||||0.44|||||||ANOVA|||Comparison between each arm/group of change in mesial bone height||||0.440
70984079|NCT02532543|141476801|SUPERIORITY|||||||0.729|||||||ANOVA|||Comparison between each arm/group of change in distal bone height||||0.729
70984080|NCT02532543|141476802|SUPERIORITY|||||||0.613|||||||ANOVA|||||||0.613
71037284|NCT00205777|141581697|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||ANOVA|||||||0.17
71037285|NCT00205777|141581698|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||ANOVA|||||||0.41
71037286|NCT00205777|141581698|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||||||0.18
71037287|NCT00205777|141581699|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||ANOVA|||||||0.97
71037288|NCT00205777|141581699|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||ANOVA|||||||0.61
71037289|NCT00205777|141581699|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.050
71037290|NCT00205777|141581699|SUPERIORITY_OR_OTHER|||||||0.061||95.0|||||ANOVA|||||||0.061
71037291|NCT00205777|141581699|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||||||0.14
71037292|NCT00205777|141581700|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||ANOVA|||||||0.15
71037293|NCT00205777|141581700|SUPERIORITY_OR_OTHER|||||||0.056||95.0|||||ANOVA|||||||0.056
71037294|NCT00205777|141581702|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||ANOVA|||Change at Month 12 in WHQ: P value was calculated using ANOVA.||||0.20
71037295|NCT00205777|141581702|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||ANOVA|||Change at Month 12 in WHQ: P value was calculated using ANOVA.||||0.12
71037296|NCT00205777|141581702|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||ANOVA|||Change at Month 12 in WHQ: P value was calculated using ANOVA.||||0.17
71037297|NCT00205777|141581702|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||ANOVA|||Change at Month 12 in WHQ: P value was calculated using ANOVA.||||0.92
71097610|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC Ratio|0.77|||||TWO_SIDED|95.0|0.3|1.99||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.99|0.30|
71097611|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC Ratio|1.21|||||TWO_SIDED|95.0|0.38|3.86||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.86|0.38|
71097612|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|0.93|||||TWO_SIDED|95.0|0.43|1.99||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.99|0.43|
71037298|NCT00205777|141581702|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||ANOVA|||Change at Month 12 in WHQ: P value was calculated using ANOVA.||||0.86
71037299|NCT00205777|141581702|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||Change at Month 24 in WHQ: P value was calculated using ANOVA.||||0.18
71037300|NCT00205777|141581702|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||ANOVA|||Change at Month 24 in WHQ: P value was calculated using ANOVA.||||0.12
71037301|NCT00205777|141581702|SUPERIORITY_OR_OTHER|||||||0.096||95.0|||||ANOVA|||Change at Month 24 in WHQ: P value was calculated using ANOVA.||||0.096
71037302|NCT00205777|141581702|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|||Change at Month 24 in WHQ: P value was calculated using ANOVA.||||0.76
71037303|NCT00205777|141581702|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||ANOVA|||Change at Month 24 in WHQ: P value was calculated using ANOVA.||||0.93
71037304|NCT00205777|141581702|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||ANOVA|||Change at Month 36 in WHQ: P value was calculated using ANOVA.||||0.36
71037305|NCT00205777|141581702|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||ANOVA|||Change at Month 36 in WHQ: P value was calculated using ANOVA.||||0.34
71037306|NCT00205777|141581702|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||ANOVA|||Change at Month 36 in WHQ: P value was calculated using ANOVA.||||0.98
71037307|NCT00205777|141581702|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANOVA|||Change at Month 36 in WHQ: P value was calculated using ANOVA.||||0.35
71037308|NCT00205777|141581702|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANOVA|||Change at Month 36 in WHQ: P value was calculated using ANOVA.||||0.35
71037309|NCT00205777|141581704|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||ANOVA|||Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.||||0.080
71037310|NCT00205777|141581704|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||ANOVA|||Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.||||0.41
71037311|NCT00205777|141581704|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||ANOVA|||Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.||||0.65
71037312|NCT00205777|141581704|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||ANOVA|||Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.||||0.18
71037313|NCT00205777|141581704|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||ANOVA|||Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.||||0.36
71037314|NCT00205777|141581704|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||ANOVA|||Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.||||0.27
71037315|NCT00205777|141581704|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||ANOVA|||Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.||||0.25
71037316|NCT00205777|141581704|SUPERIORITY_OR_OTHER|||||||0.053||95.0|||||ANOVA|||Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.||||0.053
71037317|NCT00205777|141581704|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||ANOVA|||Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.||||0.40
71037318|NCT00205777|141581704|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||ANOVA|||Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.||||0.45
71037319|NCT00205777|141581704|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||ANOVA|||Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.||||0.012
71037320|NCT00205777|141581704|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||ANOVA|||Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.||||0.54
71037321|NCT00205777|141581704|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANOVA|||Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.||||0.11
70984081|NCT02532543|141476803|SUPERIORITY|||||||0.492|||||||ANOVA|||Comparison between each arm/group at 2 mm from the height of the bone crest||||0.492
70984082|NCT02532543|141476803|SUPERIORITY|||||||0.917|||||||ANOVA|||Comparison between each arm/group at 4 mm from the height of the bone crest||||0.917
70984083|NCT02532543|141476804|SUPERIORITY|||||||0.353|||||||ANOVA|||Comparison between each arm/group of change in mid buccal soft tissue height||||0.353
70984084|NCT02532543|141476804|SUPERIORITY|||||||0.823|||||||ANOVA|||Comparison between each arm/group of change in mid palatal soft tissue height||||0.823
70984085|NCT02532543|141476804|SUPERIORITY|||||||0.243|||||||ANOVA|||Comparison between each arm/group of change in mesial soft tissue height||||0.243
70984086|NCT02532543|141476804|SUPERIORITY|||||||0.756|||||||ANOVA|||Comparison between each arm/group of change in distal soft tissue height||||0.756
70984087|NCT00906789|141476831|NON_INFERIORITY_OR_EQUIVALENCE|Given a continuous confidence score (0-100), the trapezoidal method was used to obtain the area under the LROC with bootstrapping at 10,000 iterations to obtain the 95% confidence interval (CI). Acceptance criteria for tests of non-inferiority and superiority were previously set at 95% CI upper bound of ΔAUCUA-SV less than δ=0.1 and δ=0, respectively. If the 95% CI upper bound difference of UA-SV is less than 0.1, then SV is non-inferior. If it is 0 or less than 0, then SV is superior.||||||0.05|||||||Bootstraping|||The sample size of 351 patients, in a 2:1 ratio of nodule absent to present patients was selected to provide 80% power to detect a difference in areas under the curve of 0.10 or greater. This sample size was calculated using PASS software (Hintze, 2008). Settings: • α = 0.025. • one-sided test • AUCA = 0.80 and AUCSV = 0.90.• 2:1 ratio of patients with nodules to those without • areas calculated for the entire curves • correlation 0.3\* • discrete data. • standard deviation ratios of 1\*.||||0.05
70984088|NCT02334267|141476834|SUPERIORITY_OR_OTHER||||||<|0.0001||||||trend analysis over time|Mixed Models Analysis|||||||<0.0001
70984089|NCT02334267|141476835|SUPERIORITY_OR_OTHER|||||||0.4||||||trend analysis over time|Mixed Models Analysis|||||||0.4
71037322|NCT00205777|141581704|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANOVA|||Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.||||0.35
71037323|NCT00205777|141581704|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||ANOVA|||Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.||||0.34
71037324|NCT00205777|141581706|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||ANOVA|||Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.||||0.21
71037325|NCT00205777|141581706|SUPERIORITY_OR_OTHER|||||||0.058|TWO_SIDED||||||ANOVA|||Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.||||0.058
70984090|NCT02334267|141476836|SUPERIORITY_OR_OTHER|||||||0.003||||||trend analysis over time|Mixed Models Analysis|||||||0.003
70984091|NCT02334267|141476837|SUPERIORITY_OR_OTHER||||||<|0.0001||||||trend analysis over time|Mixed Models Analysis|||||||<0.0001
70984092|NCT03291197|141476850|OTHER|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||Our study was not powered to perform statistical analysis though was still conduct to look for a trend in reduction of VAS.||||0.043
70984093|NCT01633060|141476858|OTHER|Comparison of progression-free survival (PFS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.67|||<|0.001|ONE_SIDED|95.0|0.53||||Log Rank||||||0.53|<0.001
70984094|NCT03114969|141476970|SUPERIORITY||Odds Ratio (OR)|4.657||||0.005|TWO_SIDED|95.0|1.584|13.686||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||13.686|1.584|0.005
70984095|NCT03114969|141476970|SUPERIORITY||Odds Ratio (OR)|2.478||||0.114|TWO_SIDED|95.0|0.805|7.632||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||7.632|0.805|0.114
70984096|NCT03114969|141476970|SUPERIORITY||Odds Ratio (OR)|3.499||||0.026|TWO_SIDED|95.0|1.16|10.555||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||10.555|1.160|0.026
70984097|NCT03114969|141476970|SUPERIORITY||Odds Ratio (OR)|3.943||||0.012|TWO_SIDED|95.0|1.348|11.534||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||11.534|1.348|0.012
71037326|NCT00205777|141581706|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||ANOVA|||Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.||||0.76
71037327|NCT00205777|141581706|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||ANOVA|||Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.||||0.34
71037328|NCT00205777|141581706|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||ANOVA|||Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.||||0.51
71037329|NCT00205777|141581706|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.||||0.14
71037330|NCT00205777|141581706|SUPERIORITY_OR_OTHER|||||||0.57||95.0|||||ANOVA|||Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.||||0.57
71037331|NCT00205777|141581706|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||ANOVA|||Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.||||0.78
71037332|NCT00205777|141581706|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||ANOVA|||Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.||||0.24
70984098|NCT03114969|141476970|SUPERIORITY||Odds Ratio (OR)|1.223||||0.746|TWO_SIDED|95.0|0.361|4.151||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||4.151|0.361|0.746
70984099|NCT03114969|141476970|SUPERIORITY||Odds Ratio (OR)|5.562||||0.001|TWO_SIDED|95.0|1.932|16.013||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||16.013|1.932|0.001
70984100|NCT03114969|141476970|SUPERIORITY||Odds Ratio (OR)|2.979||||0.05|TWO_SIDED|95.0|0.999|8.882||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||8.882|0.999|0.050
70984101|NCT03114969|141476970|SUPERIORITY||Odds Ratio (OR)|4.418||||0.006|TWO_SIDED|95.0|1.521|12.834||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||12.834|1.521|0.006
70984102|NCT03114969|141476970|SUPERIORITY||Odds Ratio (OR)|4.165||||0.009|TWO_SIDED|95.0|1.425|12.178||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||12.178|1.425|0.009
70984103|NCT03114969|141476970|SUPERIORITY||Odds Ratio (OR)|1.209||||0.761|TWO_SIDED|95.0|0.357|4.095||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||4.095|0.357|0.761
70984104|NCT03114969|141476971|SUPERIORITY||Odds Ratio (OR)|2.292||||0.1|TWO_SIDED|95.0|0.853|6.163||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||6.163|0.853|0.100
70984105|NCT03114969|141476971|SUPERIORITY||Odds Ratio (OR)|2.642||||0.051|TWO_SIDED|95.0|0.994|7.022||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||7.022|0.994|0.051
70984106|NCT03114969|141476972|SUPERIORITY||Odds Ratio (OR)|3.995|||<|0.001|TWO_SIDED|95.0|1.808|8.829||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||8.829|1.808|<0.001
70984107|NCT03114969|141476972|SUPERIORITY||Odds Ratio (OR)|2.181||||0.069|TWO_SIDED|95.0|0.94|5.059||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||5.059|0.940|0.069
70984108|NCT03114969|141476972|SUPERIORITY||Odds Ratio (OR)|4.855|||<|0.001|TWO_SIDED|95.0|2.339|10.08||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||10.080|2.339|<0.001
70984109|NCT03114969|141476972|SUPERIORITY||Odds Ratio (OR)|2.71||||0.01|TWO_SIDED|95.0|1.274|5.764||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||5.764|1.274|0.010
71037333|NCT00205777|141581706|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||ANOVA|||Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.||||0.78
71037334|NCT00205777|141581706|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||ANOVA|||Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.||||0.62
71037335|NCT00205777|141581706|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||ANOVA|||Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.||||0.72
71037336|NCT00205777|141581706|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.||||0.16
71037337|NCT00205777|141581706|SUPERIORITY_OR_OTHER|||||||0.059||95.0|||||ANOVA|||Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.||||0.059
71037338|NCT00205777|141581706|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||ANOVA|||Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.||||0.30
71037339|NCT00205777|141581708|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||ANOVA|||Change at Month 12 in EQ-5D: P value was calculated using ANOVA.||||0.72
71037340|NCT00205777|141581708|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||ANOVA|||Change at Month 12 in EQ-5D: P value was calculated using ANOVA.||||0.98
71037341|NCT00205777|141581708|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||ANOVA|||Change at Month 12 in EQ-5D: P value was calculated using ANOVA.||||0.84
71037342|NCT00205777|141581708|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||ANOVA|||Change at Month 12 in EQ-5D: P value was calculated using ANOVA.||||0.88
71037343|NCT00205777|141581708|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||ANOVA|||Change at Month 12 in EQ-5D: P value was calculated using ANOVA.||||0.86
71037344|NCT00205777|141581708|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||ANOVA|||Change at Month 24 in EQ-5D: P value was calculated using ANOVA.||||0.82
71037345|NCT00205777|141581708|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANOVA|||Change at Month 24 in EQ-5D: P value was calculated using ANOVA.||||0.11
71037346|NCT00205777|141581708|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||Change at Month 24 in EQ-5D: P value was calculated using ANOVA.||||0.14
71097613|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|1.09|||||TWO_SIDED|95.0|0.54|2.22||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.22|0.54|
70984110|NCT03114969|141476973|SUPERIORITY||Odds Ratio (OR)|2.503||||0.108|TWO_SIDED|95.0|0.818|7.659||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||7.659|0.818|0.108
70984111|NCT03114969|141476973|SUPERIORITY||Odds Ratio (OR)|2.409||||0.122|TWO_SIDED|95.0|0.792|7.331||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||7.331|0.792|0.122
70984112|NCT03114969|141476974|SUPERIORITY||Odds Ratio (OR)|4.887||||0.001|TWO_SIDED|95.0|1.851|12.903||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||12.903|1.851|0.001
70984113|NCT03114969|141476974|SUPERIORITY||Odds Ratio (OR)|5.484|||<|0.001|TWO_SIDED|95.0|2.106|14.284||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||14.284|2.106|<0.001
70984114|NCT03114969|141476975|SUPERIORITY||Odds Ratio (OR)|3.941|||<|0.001|TWO_SIDED|95.0|1.863|8.337||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||8.337|1.863|<0.001
70984115|NCT03114969|141476975|SUPERIORITY||Odds Ratio (OR)|2.391||||0.03|TWO_SIDED|95.0|1.088|5.256||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||5.256|1.088|0.030
70984116|NCT03114969|141476975|SUPERIORITY||Odds Ratio (OR)|4.728|||<|0.001|TWO_SIDED|95.0|2.388|9.364||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||9.364|2.388|<0.001
70984117|NCT03114969|141476975|SUPERIORITY||Odds Ratio (OR)|2.957||||0.002|TWO_SIDED|95.0|1.473|5.936||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||5.936|1.473|0.002
70984118|NCT03114969|141476976|SUPERIORITY||Odds Ratio (OR)|2.404||||0.045|TWO_SIDED|95.0|1.018|5.676||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||5.676|1.018|0.045
70984119|NCT03114969|141476976|SUPERIORITY||Odds Ratio (OR)|1.823||||0.172|TWO_SIDED|95.0|0.77|4.319||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||4.319|0.770|0.172
70984120|NCT03114969|141476976|SUPERIORITY||Odds Ratio (OR)|2.989||||0.016|TWO_SIDED|95.0|1.229|7.272||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||7.272|1.229|0.016
70984121|NCT03114969|141476976|SUPERIORITY||Odds Ratio (OR)|1.747||||0.179|TWO_SIDED|95.0|0.775|3.937||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||3.937|0.775|0.179
70984122|NCT03114969|141476976|SUPERIORITY||Odds Ratio (OR)|1.189||||0.69|TWO_SIDED|95.0|0.509|2.775||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||2.775|0.509|0.690
70984123|NCT03114969|141476976|SUPERIORITY||Odds Ratio (OR)|3.363||||0.004|TWO_SIDED|95.0|1.48|7.639||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||7.639|1.480|0.004
70984124|NCT03114969|141476976|SUPERIORITY||Odds Ratio (OR)|2.848||||0.012|TWO_SIDED|95.0|1.264|6.42||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||6.420|1.264|0.012
71097614|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|1.18|||||TWO_SIDED|95.0|0.5|2.79||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.79|0.50|
71097615|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|1.11|||||TWO_SIDED|95.0|0.56|2.19||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.19|0.56|
70984125|NCT03114969|141476976|SUPERIORITY||Odds Ratio (OR)|4.63|||<|0.001|TWO_SIDED|95.0|1.986|10.791||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||10.791|1.986|<0.001
70984126|NCT03114969|141476976|SUPERIORITY||Odds Ratio (OR)|2.037||||0.081|TWO_SIDED|95.0|0.916|4.528||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||4.528|0.916|0.081
70984127|NCT03114969|141476976|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.438|2.283||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||2.283|0.438|1.000
70984128|NCT03114969|141476977|SUPERIORITY||Odds Ratio (OR)|1.935||||0.067|TWO_SIDED|95.0|0.955|3.921||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||3.921|0.955|0.067
70984129|NCT03114969|141476977|SUPERIORITY||Odds Ratio (OR)|2.523||||0.007|TWO_SIDED|95.0|1.283|4.961||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||4.961|1.283|0.007
70984130|NCT03114969|141476978|SUPERIORITY||Odds Ratio (OR)|2.399||||0.008|TWO_SIDED|95.0|1.252|4.596||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||4.596|1.252|0.008
70984131|NCT03114969|141476978|SUPERIORITY||Odds Ratio (OR)|1.812||||0.082|TWO_SIDED|95.0|0.926|3.544||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||3.544|0.926|0.082
70984132|NCT03114969|141476978|SUPERIORITY||Odds Ratio (OR)|3.84|||<|0.001|TWO_SIDED|95.0|2.135|6.905||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||6.905|2.135|<0.001
70984133|NCT03114969|141476978|SUPERIORITY||Odds Ratio (OR)|3.231|||<|0.001|TWO_SIDED|95.0|1.81|5.766||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||5.766|1.810|<0.001
70984134|NCT03114969|141476979|SUPERIORITY||Odds Ratio (OR)|1.931||||0.12|TWO_SIDED|95.0|0.842|4.428||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||4.428|0.842|0.120
70984135|NCT03114969|141476979|SUPERIORITY||Odds Ratio (OR)|1.636||||0.232|TWO_SIDED|95.0|0.73|3.664||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||3.664|0.730|0.232
70984136|NCT03114969|141476980|SUPERIORITY||Odds Ratio (OR)|4.217|||<|0.001|TWO_SIDED|95.0|2.019|8.807||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||8.807|2.019|<0.001
70984137|NCT03114969|141476980|SUPERIORITY||Odds Ratio (OR)|5.41|||<|0.001|TWO_SIDED|95.0|2.66|11.005||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||11.005|2.660|<0.001
71037347|NCT00205777|141581708|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANOVA|||Change at Month 24 in EQ-5D: P value was calculated using ANOVA.||||0.22
70984138|NCT03114969|141476981|SUPERIORITY||Odds Ratio (OR)|2.477||||0.007|TWO_SIDED|95.0|1.274|4.815||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||4.815|1.274|0.007
70984139|NCT03114969|141476981|SUPERIORITY||Odds Ratio (OR)|2.748||||0.006|TWO_SIDED|95.0|1.328|5.683||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||5.683|1.328|0.006
71037348|NCT00205777|141581708|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||ANOVA|||Change at Month 24 in EQ-5D: P value was calculated using ANOVA.||||0.88
71037349|NCT00205777|141581708|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||ANOVA|||Change at Month 36 in EQ-5D: P value was calculated using ANOVA.||||0.96
71037350|NCT00205777|141581708|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|||Change at Month 36 in EQ-5D: P value was calculated using ANOVA.||||0.76
71037351|NCT00205777|141581708|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||ANOVA|||Change at Month 36 in EQ-5D: P value was calculated using ANOVA.||||0.92
71037352|NCT00205777|141581708|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||ANOVA|||Change at Month 36 in EQ-5D: P value was calculated using ANOVA.||||0.89
71037353|NCT00205777|141581708|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||ANOVA|||Change at Month 36 in EQ-5D: P value was calculated using ANOVA.||||0.83
70984140|NCT03114969|141476981|SUPERIORITY||Odds Ratio (OR)|3.896|||<|0.001|TWO_SIDED|95.0|2.133|7.118||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||7.118|2.133|<0.001
70984141|NCT03114969|141476981|SUPERIORITY||Odds Ratio (OR)|4.777|||<|0.001|TWO_SIDED|95.0|2.508|9.1||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||9.100|2.508|<0.001
70984142|NCT03114969|141476982|SUPERIORITY||Odds Ratio (OR)|7.347||||0.176|TWO_SIDED|95.0|0.408|132.143||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||132.143|0.408|0.176
70984143|NCT03114969|141476982|SUPERIORITY||Odds Ratio (OR)|9.3||||0.128|TWO_SIDED|95.0|0.526|164.465||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||164.465|0.526|0.128
70984144|NCT03114969|141476982|SUPERIORITY||Odds Ratio (OR)|20.454||||0.038|TWO_SIDED|95.0|1.19|351.613||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||351.613|1.190|0.038
70984145|NCT03114969|141476982|SUPERIORITY||Odds Ratio (OR)|18.776||||0.041|TWO_SIDED|95.0|1.131|311.669||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||311.669|1.131|0.041
70984146|NCT03114969|141476982|SUPERIORITY||Odds Ratio (OR)|8.873||||0.141|TWO_SIDED|95.0|0.484|162.775||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||162.775|0.484|0.141
70984147|NCT03114969|141476982|SUPERIORITY||Odds Ratio (OR)|10.215||||0.126|TWO_SIDED|95.0|0.519|200.904||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||200.904|0.519|0.126
70984148|NCT03114969|141476982|SUPERIORITY||Odds Ratio (OR)|13.717||||0.082|TWO_SIDED|95.0|0.715|263.125||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||263.125|0.715|0.082
70984149|NCT03114969|141476982|SUPERIORITY||Odds Ratio (OR)|28.283||||0.024|TWO_SIDED|95.0|1.561|512.532||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||512.532|1.561|0.024
70984150|NCT03114969|141476982|SUPERIORITY||Odds Ratio (OR)|21.736||||0.038|TWO_SIDED|95.0|1.183|399.541||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||399.541|1.183|0.038
70984151|NCT03114969|141476982|SUPERIORITY||Odds Ratio (OR)|7.603||||0.188|TWO_SIDED|95.0|0.371|155.763||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||155.763|0.371|0.188
70984152|NCT03114969|141476983|SUPERIORITY||Odds Ratio (OR)|7.781||||0.147|TWO_SIDED|95.0|0.488|124.117||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||124.117|0.488|0.147
70984153|NCT03114969|141476983|SUPERIORITY||Odds Ratio (OR)|9.786||||0.12|TWO_SIDED|95.0|0.553|173.301||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||173.301|0.553|0.120
70984154|NCT03114969|141476984|SUPERIORITY||Odds Ratio (OR)|2.089||||0.395|TWO_SIDED|95.0|0.383|11.389||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||11.389|0.383|0.395
70984155|NCT03114969|141476984|SUPERIORITY||Odds Ratio (OR)|3.25||||0.166|TWO_SIDED|95.0|0.612|17.244||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||17.244|0.612|0.166
70984156|NCT03114969|141476984|SUPERIORITY||Odds Ratio (OR)|3.196||||0.175|TWO_SIDED|95.0|0.596|17.14||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||17.140|0.596|0.175
70984157|NCT03114969|141476984|SUPERIORITY||Odds Ratio (OR)|5.408||||0.042|TWO_SIDED|95.0|1.059|27.61||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||27.610|1.059|0.042
70984158|NCT03114969|141476985|SUPERIORITY||Odds Ratio (OR)|12.145||||0.09|TWO_SIDED|95.0|0.68|216.818||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||216.818|0.680|0.090
70984159|NCT03114969|141476985|SUPERIORITY||Odds Ratio (OR)|9.991||||0.13|TWO_SIDED|95.0|0.508|196.435||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||196.435|0.508|0.130
70984160|NCT03114969|141476986|SUPERIORITY||Odds Ratio (OR)|11.907||||0.079|TWO_SIDED|95.0|0.753|188.208||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||188.208|0.753|0.079
70984161|NCT03114969|141476986|SUPERIORITY||Odds Ratio (OR)|15.06||||0.063|TWO_SIDED|95.0|0.866|262.042||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||262.042|0.866|0.063
70984162|NCT03114969|141476987|SUPERIORITY||Odds Ratio (OR)|2.67||||0.239|TWO_SIDED|95.0|0.521|13.69||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||13.690|0.521|0.239
70984163|NCT03114969|141476987|SUPERIORITY||Odds Ratio (OR)|2.929||||0.2|TWO_SIDED|95.0|0.567|15.125||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||15.125|0.567|0.200
70984164|NCT03114969|141476987|SUPERIORITY||Odds Ratio (OR)|4.269||||0.078|TWO_SIDED|95.0|0.848|21.489||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||21.489|0.848|0.078
70984165|NCT03114969|141476987|SUPERIORITY||Odds Ratio (OR)|5.132||||0.046|TWO_SIDED|95.0|1.031|25.55||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||25.550|1.031|0.046
71097616|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|1.09|||||TWO_SIDED|95.0|0.58|2.06||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.06|0.58|
71097617|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|0.98|||||TWO_SIDED|95.0|0.46|2.13||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.13|0.46|
71097618|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|0.98|||||TWO_SIDED|95.0|0.38|2.55||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.55|0.38|
71097619|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|1.23|||||TWO_SIDED|95.0|0.5|3.0||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.00|0.50|
71097620|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|1.25|||||TWO_SIDED|95.0|0.42|3.72||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.72|0.42|
71097621|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|0.69|||||TWO_SIDED|95.0|0.29|1.68||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.68|0.29|
71097622|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|0.92|||||TWO_SIDED|95.0|0.4|2.1||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.10|0.40|
70984166|NCT03114969|141476988|SUPERIORITY||Odds Ratio (OR)|3.483||||0.02|TWO_SIDED|95.0|1.218|9.961||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||9.961|1.218|0.020
70984167|NCT03114969|141476988|SUPERIORITY||Odds Ratio (OR)|2.284||||0.143|TWO_SIDED|95.0|0.757|6.895||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||6.895|0.757|0.143
70984168|NCT03114969|141476988|SUPERIORITY||Odds Ratio (OR)|5.268||||0.006|TWO_SIDED|95.0|1.615|17.187||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||17.187|1.615|0.006
70984169|NCT03114969|141476988|SUPERIORITY||Odds Ratio (OR)|4.655||||0.009|TWO_SIDED|95.0|1.478|14.666||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||14.666|1.478|0.009
70984170|NCT03114969|141476988|SUPERIORITY||Odds Ratio (OR)|1.274||||0.679|TWO_SIDED|95.0|0.405|4.005||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||4.005|0.405|0.679
70984171|NCT03114969|141476988|SUPERIORITY||Odds Ratio (OR)|3.804||||0.01|TWO_SIDED|95.0|1.372|10.544||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||10.544|1.372|0.010
70984172|NCT03114969|141476988|SUPERIORITY||Odds Ratio (OR)|2.555||||0.083|TWO_SIDED|95.0|0.886|7.369||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||7.369|0.886|0.083
70984173|NCT03114969|141476988|SUPERIORITY||Odds Ratio (OR)|5.93||||0.002|TWO_SIDED|95.0|1.89|18.611||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||18.611|1.890|0.002
71097623|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|1.33|||||TWO_SIDED|95.0|0.49|3.64||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.64|0.49|
71097624|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|1.7|||||TWO_SIDED|95.0|0.7|4.12||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.12|0.70|
70984174|NCT03114969|141476988|SUPERIORITY||Odds Ratio (OR)|4.929||||0.007|TWO_SIDED|95.0|1.556|15.612||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||15.612|1.556|0.007
70984175|NCT03114969|141476988|SUPERIORITY||Odds Ratio (OR)|1.208||||0.746|TWO_SIDED|95.0|0.385|3.788||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||3.788|0.385|0.746
70984176|NCT03114969|141476989|SUPERIORITY||Odds Ratio (OR)|1.502||||0.404|TWO_SIDED|95.0|0.578|3.905||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||3.905|0.578|0.404
70984177|NCT03114969|141476989|SUPERIORITY||Odds Ratio (OR)|1.591||||0.33|TWO_SIDED|95.0|0.625|4.05||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||4.050|0.625|0.330
70984178|NCT03114969|141476990|SUPERIORITY||Odds Ratio (OR)|1.738||||0.189|TWO_SIDED|95.0|0.761|3.968||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||3.968|0.761|0.189
71037354|NCT00367133|141581710|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANCOVA|Repeated Measures Model. Adjusted for baseline visual acuity and prior photocoagulation; Accounted for correlated data from subjects with 2 study eyes||P values for two group comparisons for difference in mean change.||||0.02
71037355|NCT00367133|141581710|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|Repeated Measures Model. Adjusted for baseline visual acuity and prior photocoagulation; Accounted for correlated data from subjects with 2 study eyes||P Values for 2 group comparisons of difference in mean change||||0.002
70984179|NCT03114969|141476990|SUPERIORITY||Odds Ratio (OR)|2.079||||0.086|TWO_SIDED|95.0|0.901|4.799||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||4.799|0.901|0.086
70984180|NCT03114969|141476990|SUPERIORITY||Odds Ratio (OR)|1.95||||0.082|TWO_SIDED|95.0|0.918|4.142||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||4.142|0.918|0.082
70984181|NCT03114969|141476990|SUPERIORITY||Odds Ratio (OR)|2.415||||0.018|TWO_SIDED|95.0|1.161|5.024||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||5.024|1.161|0.018
71037356|NCT00367133|141581710|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||ANCOVA|Repeated Measures Model. Adjusted for baseline visual acuity and prior photocoagulation; Accounted for correlated data from subjects with 2 study eyes||P Values for 2 group comparisons of difference in mean change||||0.49
71097625|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|1.37|||||TWO_SIDED|95.0|0.6|3.14||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.14|0.60|
71097626|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|0.81|||||TWO_SIDED|95.0|0.3|2.21||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.21|0.30|
70984182|NCT03114969|141476991|SUPERIORITY||Odds Ratio (OR)|1.51||||0.472|TWO_SIDED|95.0|0.492|4.633||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||4.633|0.492|0.472
70984183|NCT03114969|141476991|SUPERIORITY||Odds Ratio (OR)|1.402||||0.553|TWO_SIDED|95.0|0.459|4.283||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||4.283|0.459|0.553
70984184|NCT03114969|141476992|SUPERIORITY||Odds Ratio (OR)|2.523||||0.052|TWO_SIDED|95.0|0.993|6.407||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||6.407|0.993|0.052
70984185|NCT03114969|141476992|SUPERIORITY||Odds Ratio (OR)|2.757||||0.029|TWO_SIDED|95.0|1.107|6.862||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||6.862|1.107|0.029
70984186|NCT03114969|141476993|SUPERIORITY||Odds Ratio (OR)|2.434||||0.024|TWO_SIDED|95.0|1.123|5.276||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||5.276|1.123|0.024
70984187|NCT03114969|141476993|SUPERIORITY||Odds Ratio (OR)|2.389||||0.035|TWO_SIDED|95.0|1.061|5.376||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||5.376|1.061|0.035
71037357|NCT00367133|141581713|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||GEE Repeated Measures|Hochberg procedure used to determine statistical significance.||Proportion with 15-letter or more worsening||||0.03
70984188|NCT03114969|141476993|SUPERIORITY||Odds Ratio (OR)|2.889||||0.003|TWO_SIDED|95.0|1.434|5.819||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||5.819|1.434|0.003
70984189|NCT03114969|141476993|SUPERIORITY||Odds Ratio (OR)|2.974||||0.003|TWO_SIDED|95.0|1.461|6.055||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||6.055|1.461|0.003
70984190|NCT00949650|141476994|SUPERIORITY_OR_OTHER|||||||0.0002||||||Two-sided p-value from log-rank test stratified by EGFR mutation group and race.|Log Rank|||||||0.0002
70984191|NCT00949650|141476994|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.576||||0.0002||95.0|0.426|0.778|||Regression, Cox|Cox Proportional Hazard (PH) regression stratified by epidermal growth factor receptor (EGFR) mutation group and race.|Afatinib 40 mg versus Pemetrexed/Cisplatin Chemotherapy.|||0.778|0.426|0.0002
70984192|NCT00949650|141476995|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.802|||<|0.0001||95.0|2.855|8.075|||Regression, Logistic|Logistic regression stratified for EGFR mutation group and race.|Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.|||8.075|2.855|<0.0001
71037358|NCT00367133|141581713|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||GEE Repeated Measures|Hochberg procedure used to determine statistical significance.||Proportion with 15-letter or more worsening||||0.01
71037359|NCT00367133|141581713|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||GEE Repeated Measures|Hochberg procedure used to determine statistical significance.||Proportion with 15-letter or more worsening||||0.82
71037360|NCT00367133|141581714|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Repeated Measures Model. Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P value not adjusted for multiple comparisons||||<0.001
71037361|NCT00367133|141581714|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Repeated Measures Model. Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Value not adjusted for multiple comparisons||||<0.001
71037362|NCT00367133|141581714|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||ANCOVA|Repeated Measures Model. Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Values not adjusted for multiple comparisons||||0.91
71037363|NCT00367133|141581716|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Values not adjusted for multiple comparisons||||<0.001
71037364|NCT00367133|141581716|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Values not adjusted for multiple comparisons||||<0.001
71037365|NCT00367133|141581716|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Value not adjusted for multiple comparisons||||0.60
71037366|NCT00367133|141581717|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Values not adjusted for multiple comparisons||||<0.001
70984193|NCT00949650|141476996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.288||||0.0118||95.0|1.202|4.356|||Regression, Logistic|Logistic regression stratified for EGFR mutation group and race.|Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.|||4.356|1.202|0.0118
71037367|NCT00367133|141581717|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Value not adjusted for statistical analysis||||<0.001
71037368|NCT00367133|141581717|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Value not adjusted for statistical analysis||||0.55
71037369|NCT01252953|141581726|OTHER|Time to first event|Rate Ratio|0.91||||0.004|TWO_SIDED|95.0|0.85|0.97|||Log Rank|||||0.97|0.85|0.004
71037370|NCT01252953|141581727|OTHER|Time to first event|Rate Ratio|0.93||||0.052|TWO_SIDED|95.0|0.86|1.0|||Log Rank|||||1|0.86|0.052
71037371|NCT01252953|141581728|OTHER|Time to first event|Rate Ratio|0.99|||||TWO_SIDED|95.0|0.87|1.12||In accordance with the data analysis plan, if the outcome of a major atherosclerotic event did not reach significance, there was no hypothesis testing for presumed ischemic stroke, so no P value is given.||||||1.12|0.87|
71037372|NCT01252953|141581729|OTHER|Time to first event|Rate Ratio|0.93||||0.02|TWO_SIDED|95.0|0.88|0.99|||Log Rank|||||0.99|0.88|0.02
71037373|NCT01665508|141581733|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Continuous variables were reported as the mean ± (SD) and categorical data presented as frequency and percentage of the sample. Comparisons between baseline and post-treatment SAQ scores, SF-36v2 scores, and CPET variables were performed using a paired t-test for normally distributed variables or a Wilcoxon signed-rank test for non-normally distributed variables. Normality was defined by the Shapiro-Wilk test. For categorical variables, data were compared using a chi-squared test.||||< 0.05
71037374|NCT00858780|141581745|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.17||||0.007|TWO_SIDED|95.0|1.72|29.82|||GEE Model|||Analysis was performed using a generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, their interaction, and the stratification factor as factors in the model.||29.82|1.72|0.007
71037375|NCT00858780|141581745|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.362|TWO_SIDED|95.0|0.54|5.41|||GEE Model|||Analysis was performed using a GEE model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, their interaction, and the stratification factor as factors in the model.||5.41|0.54|0.362
71037376|NCT00858780|141581745|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.2||||0.044|TWO_SIDED|95.0|1.04|16.99|||GEE Model|||Analysis was performed using a GEE model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, their interaction, and the stratification factor as factors in the model.||16.99|1.04|0.044
71037377|NCT02615249|141581768|OTHER||Kappa statistic|0.28|||||TWO_SIDED|95.0|-0.01|0.58||||||Comparison between 0.12 mg/cm2 copper sulfate and copper sulfate 2% in petrolatum||0.58|-0.01|
70984194|NCT00949650|141476997|SUPERIORITY_OR_OTHER|||||||0.7916||||||Two-sided p-value from log-rank test stratified by EGFR mutation group and race.|Log Rank|||||||0.7916
70984195|NCT00949650|141476997|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.385||95.0|0.66|1.174|||Regression, Cox|Cox PH regression stratified by EGFR mutation group and race.|Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.|||1.174|0.660|0.3850
70984196|NCT00949650|141476998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.82|||<|0.0001||95.0|-13.64|-5.99|||ANCOVA|Adjusted for baseline SoD, EGFR mutation group and race.|Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.|||-5.99|-13.64|<0.0001
70984197|NCT00949650|141477001|SUPERIORITY_OR_OTHER|||||||0.0062||||||Two-sided p-value from log-rank test stratified by EGFR mutation group and race.|Log Rank|||||||0.0062
71037378|NCT02615249|141581768|OTHER||Kappa statistic|0.45|||||TWO_SIDED|95.0|0.24|0.66||||||Comparison between 0.24 mg/cm2 manganese chloride and manganese chloride 2% in petrolatum||0.66|0.24|
71037379|NCT02615249|141581768|OTHER||Kappa statistic|0.23|||||TWO_SIDED|95.0|0.07|0.38|||||Kappa statistic is for 0.33 mg/cm2 tin chloride vs 1% tin chloride in petrolatum reference allergen|Comparison between 0.33 mg/cm2 tin chloride and tin chloride 1% in petrolatum||0.38|0.07|
71037380|NCT02615249|141581768|OTHER||Kappa statistic|0.4|||||TWO_SIDED|95.0|0.15|0.65|||||Kappa statistic is for 0.22 mg Ti/cm2 ammonium titanium oxide oxalate vs 19% ammonium titanium oxide oxalate in petrolatum reference allergen|Comparison between 0.22 mg Ti/cm2 ammonium titanium oxide oxalate and ammnium titanium oxide oxalate 19% in petrolatum||0.65|0.15|
71037381|NCT02615249|141581768|OTHER||Kappa statistic|0.52|||||TWO_SIDED|95.0|0.3|0.73|||||Kappa statistic is for 0.050 mg V/cm2 vanadium sulfate vs 1.5% vanadium sulfate in petrolatum reference allergen|Comparison between 0.050 mg/cm2 vanadium sulfate and vanadium sulfate 1.5% in petrolatum||0.73|0.30|
71037382|NCT02615249|141581768|OTHER||Kappa statistic|0.36|||||TWO_SIDED|95.0|0.07|0.38|||||Kappa statistic is for 0.24 mg/cm2 zinc chloride vs 2% zinc chloride in petrolatum reference allergen|Comparison betweenm 0.24 mg/cm2 zinc chloride and zinc chloride 2% in petrolatum||0.38|0.07|
71037383|NCT03703258|141581774|SUPERIORITY||Slope|0.14|STANDARD_ERROR_OF_MEAN|0.26||0.6|TWO_SIDED||||||Mixed Models Analysis||Condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|||||.60
71037384|NCT03703258|141581774|SUPERIORITY||Cohen's D|0.36|||||TWO_SIDED||||||||Between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|||||
71037385|NCT03703258|141581775|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.27||0.94|TWO_SIDED||||||Mixed Models Analysis||Condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|||||.94
71037386|NCT03703258|141581775|SUPERIORITY||Cohen's D|-0.01|||||TWO_SIDED||||||||Between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|||||
71037387|NCT03703258|141581776|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.13||0.38|TWO_SIDED||||||Mixed Models Analysis||Condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|||||.38
71037388|NCT03703258|141581776|SUPERIORITY||Cohen's D|-0.15|||||TWO_SIDED||||||||Between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|||||
71037389|NCT03703258|141581777|SUPERIORITY||Slope|-0.28|STANDARD_ERROR_OF_MEAN|0.14||0.04|TWO_SIDED||||||Mixed Models Analysis||Condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|||||.04
71037390|NCT03703258|141581777|SUPERIORITY||Cohen's D|-0.7|||||TWO_SIDED||||||||Between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|||||
71037391|NCT03703258|141581778|SUPERIORITY||Slope|-1.23|STANDARD_ERROR_OF_MEAN|1.88||0.51|TWO_SIDED||||||Mixed Models Analysis||Post-intervention condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to post-intervention only||||.51
71037392|NCT03703258|141581778|SUPERIORITY||Slope|-0.9|STANDARD_ERROR_OF_MEAN|1.9||0.64|TWO_SIDED||||||Mixed Models Analysis||3 month condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to 3 months||||.64
70984198|NCT00949650|141477001|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.589||||0.2133||95.0|0.401|0.866|||Regression, Cox|Cox PH regression stratified by EGFR mutation group and race.|Afatinib 40 mg vs. Pemetrexed/Cisplatin Chemotherapy, if HR\<1 then favours Afatinib 40 mg.|||0.866|0.401|0.2133
70984199|NCT00949650|141477002|SUPERIORITY_OR_OTHER|||||||0.0129||||||Two-sided p-value from log-rank test stratified by EGFR mutation group and race.|Log Rank|||||||0.0129
70984200|NCT00949650|141477002|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0078||95.0|0.499|0.927|||Regression, Cox|Cox PH regression stratified by EGFR mutation group and race.|Afatinib 40 mg vs. Pemetrexed/Cisplatin Chemotherapy, if HR\<1 then favours Afatinib 40 mg.|||0.927|0.499|0.0078
71037393|NCT03703258|141581778|SUPERIORITY||Cohen's D|-0.1|||||TWO_SIDED||||||||Post-intervention between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to post-intervention only||||
70984201|NCT00949650|141477003|SUPERIORITY_OR_OTHER|||||||0.1882||||||Two-sided p-value from log-rank test stratified by EGFR mutation group and race.|Log Rank|||||||0.1882
70984202|NCT00949650|141477003|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.826||||0.0427||95.0|0.618|1.104|||Regression, Cox|Cox PH regression stratified by EGFR mutation group and race.|Afatinib 40 mg vs. Pemetrexed/Cisplatin Chemotherapy, if HR\<1 then favours Afatinib 40 mg.|||1.104|0.618|0.0427
70984203|NCT00069121|141477060|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0038|TWO_SIDED|95.0|0.69|0.93||This test used a two-sided significance level of 5%.|Log Rank||The hazard ratio was calculated as XELOX versus 5-FU/LV arms.|||0.93|0.69|0.0038
70984204|NCT00069121|141477061|OTHER|Descriptive analysis only.|Hazard Ratio (HR)|0.78||||0.0015|TWO_SIDED|95.0|0.67|0.91|||Log Rank||The hazard ratio was calculated as XELOX versus 5-FU/LV arms.|||0.91|0.67|0.0015
70984205|NCT00069121|141477063|OTHER|Descriptive analysis only.|Hazard Ratio (HR)|0.83||||0.0367|TWO_SIDED|95.0|0.7|0.99|||Log Rank||The hazard ratio was calculated as XELOX versus 5-FU/LV arms.|||0.99|0.70|0.0367
70984206|NCT01832961|141477065|OTHER||||||<|0.05|||||||Friedman's Test|Friedman's test followed by Dunn's multiple comparison||The statistical analysis compared the results: immediately after to baseline values, after 20 minutes of rest to baseline values and after 20 minutes of rest to values immediately after using Friedman's Test followed by Dunn's multiple comparison test|The effect of size used to calculate responsiveness and classified as small (0.2), moderate (0.5) and large (0.8).|||<0.05
71037394|NCT03703258|141581778|SUPERIORITY||Cohen's D|0.02|||||TWO_SIDED||||||||3 month between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to 3 months||||
71037395|NCT03703258|141581779|SUPERIORITY||Slope|0.64|STANDARD_ERROR_OF_MEAN|0.3||0.04|TWO_SIDED||||||Mixed Models Analysis||Post-intervention condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to post-intervention only||||.04
71037396|NCT03703258|141581779|SUPERIORITY||Slope|0.29|STANDARD_ERROR_OF_MEAN|0.3||0.34|TWO_SIDED||||||Mixed Models Analysis||3 month condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to 3 months||||.34
71037397|NCT03703258|141581779|SUPERIORITY||Cohen's D|0.92|||||TWO_SIDED||||||||Post-intervention between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Positive values favor intervention and negative values favor control.|Baseline to post-intervention only||||
71037398|NCT03703258|141581779|SUPERIORITY||Cohen's D|0.68|||||TWO_SIDED||||||||3 month between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Positive values favor intervention and negative values favor control.|Baseline to 3 months||||
70984207|NCT01832961|141477066|OTHER||||||<|0.05|||||||Friedman's Test|||The statistical analysis compared the results: immediately after to baseline values, after 20 minutes of rest to baseline values and after 20 minutes of rest to values immediately after using Friedman's Test followed by Dunn's multiple comparison test|The effect size was used to calculate responsiveness and classifed as small (0.2), moderate (0.5) and large (0.8)|||<0.05
70984208|NCT01832961|141477067|OTHER||||||<|0.05|||||||Friedman's Test|||The statistical analysis compared the results: immediately after to baseline values, after 20 minutes of rest to baseline values and after 20 minutes of rest to values immediately after using Friedman's Test followed by Dunn's multiple comparison test|The effect size was used to calculate responsiveness and classifed as small (0.2), moderate (0.5) and large (0.8)|||<0.05
70984209|NCT01832961|141477068|OTHER||||||<|0.05|||||||T-test|T-test was used to comparisons before and after FeNO results||||||<0.05
70984210|NCT01832961|141477069|OTHER||||||<|0.05|||||||T-test|||||||<0.05
70984211|NCT01274897|141477131|SUPERIORITY_OR_OTHER||Lower limit of the two-sided 95% CI|71.0|||||TWO_SIDED|95.0|71.0|81.0||The immune response considered sufficient if for serogroup A the lower limit of the two-sided 95% Clopper-Pearson confidence interval (CI) of the percentage of subjects with hSBA seroresponse is ≥50%.|Clopper and Pearson||For serogroup A.|The null hypothesis associated with the primary immunogenicity objective is that for at least one of the four serogroups, the percentage of subjects with hSBA seroresponse at 29 days postvaccination is \< 50%.||81|71|
70984212|NCT01274897|141477131|SUPERIORITY_OR_OTHER||Lower limit of the two-sided 95% CI|82.0|||||TWO_SIDED|95.0|82.0|90.0||The immune response was considered sufficient if for serogroup C, the lower limit of the two-sided 95% CI of the percentage of subjects with hSBA seroresponse was ≥50%.|Clopper and Pearson||For the serogroup C|The null hypothesis associated with the primary immunogenicity objective is that for at least one of the four serogroups, the percentage of subjects with hSBA seroresponse at 29 days postvaccination is \< 50%.||90|82|
70984213|NCT01274897|141477131|SUPERIORITY_OR_OTHER||Lower limit of the two-sided 95% CI|23.0|||||TWO_SIDED|95.0|23.0|33.0||The immune response was considered sufficient if for serogroup W, the lower limit of the two-sided 95% CI of the percentage of subjects with hSBA seroresponse was ≥50%.|Clopper and Pearson||For the serogroup W|The null hypothesis associated with the primary immunogenicity objective is that for at least one of the four serogroups, the percentage of subjects with hSBA seroresponse at 29 days postvaccination is \< 50%.||33|23|
70984214|NCT01274897|141477131|SUPERIORITY_OR_OTHER||Lower limit of the two-sided 95% CI|63.0|||||TWO_SIDED|95.0|63.0|74.0||The immune response was considered sufficient if for serogroup Y, the lower limit of the two-sided 95% CI of the percentage of subjects with hSBA seroresponse was ≥50%.|Clopper and Pearson||For serogroup Y|The null hypothesis associated with the primary immunogenicity objective is that for at least one of the four serogroups, the percentage of subjects with hSBA seroresponse at 29 days postvaccination is \< 50%.||74|63|
70984215|NCT01821677|141477135|SUPERIORITY|||||||0.16|||||||ANCOVA|||||||0.16
70984216|NCT01821677|141477135|SUPERIORITY|||||||0.07|||||||ANCOVA|||||||0.07
70984217|NCT01821677|141477135|SUPERIORITY|||||||0.03|||||||ANCOVA|||||||0.03
70984218|NCT01821677|141477136|SUPERIORITY|||||||0.42|||||||ANCOVA|||||||0.42
70984219|NCT01821677|141477136|SUPERIORITY|||||||0.28|||||||ANCOVA|||||||0.28
70984220|NCT01821677|141477136|SUPERIORITY|||||||0.14|||||||ANCOVA|||||||0.14
70984221|NCT01855789|141477137|NON_INFERIORITY|Non-inferiority of TCZ + PBO was claimed if the upper bound of the 95% confidence interval (CI) for the mean difference was below 0.6.|Estimated Mean Difference|0.318|STANDARD_ERROR_OF_MEAN|0.139|||TWO_SIDED|95.0|0.045|0.592||||||Analysis of covariance (ANCOVA) model included Week 24 DAS28 as a covariate, treatment group, and the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>/=2.6 to \</=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>/=100 kg qw), participant anti-tumor necrosis factor (anti-TNF) exposure (Yes/No).||0.592|0.045|
70984222|NCT01855789|141477138|SUPERIORITY||ACR 20 Response Rate Difference|-10.2||||0.0746|TWO_SIDED|95.0|-20.2|-0.2|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 40: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||-0.2|-20.2|0.0746
70984223|NCT01855789|141477138|SUPERIORITY||ACR 20 Response Rate Difference|-8.8||||0.1159|TWO_SIDED|95.0|-19.3|1.6|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 52: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||1.6|-19.3|0.1159
70984224|NCT01855789|141477138|SUPERIORITY||ACR 20 Response Rate Difference|-8.2|||||TWO_SIDED|95.0|-15.8|-0.6|||||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 24||-0.6|-15.8|
70984225|NCT01855789|141477139|SUPERIORITY||ACR 50 Response Rate Difference|-13.6||||0.0377|TWO_SIDED|95.0|-24.8|-2.4|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 40: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||-2.4|-24.8|0.0377
70984226|NCT01855789|141477139|SUPERIORITY||ACR 50 Response Rate Difference|-15.0||||0.013|TWO_SIDED|95.0|-26.2|-3.7|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 52: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||-3.7|-26.2|0.0130
70984227|NCT01855789|141477139|SUPERIORITY||ACR 50 Response Rate Difference|-10.9|||||TWO_SIDED|95.0|-21.4|-0.4|||||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 24||-0.4|-21.4|
70984228|NCT01855789|141477140|SUPERIORITY||ACR 70 Response Rate Difference|-8.2||||0.3599|TWO_SIDED|95.0|-19.2|2.9|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 40: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||2.9|-19.2|0.3599
70984229|NCT01855789|141477140|SUPERIORITY||ACR 70 Response Rate Difference|-11.6||||0.0663|TWO_SIDED|95.0|-22.8|-0.3|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 52: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||-0.3|-22.8|0.0663
70984230|NCT01855789|141477140|SUPERIORITY||ACR 70 Response Rate Difference|-8.2|||||TWO_SIDED|95.0|-19.4|3.1|||||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 24||3.1|-19.4|
70984231|NCT01855789|141477141|SUPERIORITY||DAS28 Worsening Rate Difference|7.5||||0.2371|TWO_SIDED|95.0|-2.4|17.3|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 40: Analysis of association between treatment group and worsening in DAS28, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||17.3|-2.4|0.2371
70984232|NCT01855789|141477141|SUPERIORITY||DAS28 Worsening Rate Difference|3.4||||0.4811|TWO_SIDED|95.0|-6.9|13.7|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 52: Analysis of association between treatment group and worsening in DAS28, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||13.7|-6.9|0.4811
70984233|NCT01855789|141477142|SUPERIORITY||DAS28 Remission Rate Difference|-9.5||||0.1062|TWO_SIDED|95.0|-20.9|1.8|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 40: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||1.8|-20.9|0.1062
70984234|NCT01855789|141477142|SUPERIORITY||DAS28 Remission Rate Difference|-6.8||||0.3611|TWO_SIDED|95.0|-18.2|4.6|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 52: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||4.6|-18.2|0.3611
70984235|NCT01855789|141477143|SUPERIORITY||Low DAS28 Rate Difference|-13.6||||0.0228|TWO_SIDED|95.0|-24.0|-3.3|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 40: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||-3.3|-24.0|0.0228
70984236|NCT01855789|141477143|SUPERIORITY||Low DAS28 Rate Difference|-5.4||||0.3665|TWO_SIDED|95.0|-16.3|5.4|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 52: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||5.4|-16.3|0.3665
70984237|NCT01855789|141477144|SUPERIORITY||Estimated Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-0.21|0.68|||||TCZ + PBO minus TCZ + MTX|ANCOVA model included Week 24 bone erosion as a covariate, treatment group, and the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>/=2.6 to \</=3.2), participant anti-TNF exposure (Yes/No), baseline weight-by-dosing group (\<80 kg q2w, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw).||0.68|-0.21|
70984238|NCT01582282|141477160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.64||||0.028|||||||ANCOVA|||||||0.028
70984239|NCT01582282|141477160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.72||||0.009|||||||ANCOVA|||||||0.009
70984240|NCT01582282|141477161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53||||0.013|||||||ANCOVA|||||||0.013
70984241|NCT01582282|141477161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65||||0.003|||||||ANCOVA|||||||0.003
70984242|NCT01582282|141477162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48||||0.808|||||||ANCOVA|||||||0.808
70984243|NCT01582282|141477162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.328|||||||ANCOVA|||||||0.328
70984244|NCT01582282|141477163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1||||0.508|||||||ANCOVA|||||||0.508
70984245|NCT01582282|141477163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43||||0.962|||||||ANCOVA|||||||0.962
70984246|NCT01582282|141477164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.84||||0.363|||||||ANCOVA|||||||0.363
70984247|NCT01582282|141477164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.978|||||||ANCOVA|||||||0.978
70984248|NCT01582282|141477165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.14||||0.785|||||||ANCOVA|||||||0.785
70984249|NCT01582282|141477165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.45||||0.811|||||||ANCOVA|||||||0.811
70984250|NCT00112151|141477169|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.025|TWO_SIDED|||||A one-sided P-value of \<0.025 was used to define statistical significance|Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (any T). The primary analysis was conducted in the PRT groups and compared CS-PFP at 12 months with any T to placebo, adjusted for baseline CS-PFP score.||||<0.025
70984251|NCT00112151|141477169|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.025|TWO_SIDED|||||A one-sided P-value of \<0.025 was used to define statistical significance.|Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (any T). To address whether the effects of any T on physical function are the same without PRT, the analysis was also conducted in the No PRT groups, comparing CS-PFP at 12 months with any T to placebo, adjusted for baseline CS-PFP score.||||<0.025
70984252|NCT00112151|141477170|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in average upper body strength with any T to placebo in subjects assigned to PRT.||||<0.05
70984253|NCT00112151|141477170|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in average upper body strength with any T to placebo in subjects assigned to no PRT.||||<0.05
70984254|NCT00112151|141477171|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in average lower body strength with any T to placebo in subjects assigned to PRT.||||<0.05
70984255|NCT00112151|141477171|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in average lower body strength with any T to placebo in subjects assigned to no PRT.||||<0.05
70984256|NCT00112151|141477172|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in leg extensor power with any T to placebo in subjects assigned to PRT.||||<0.05
70984257|NCT00112151|141477172|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in leg extensor power with any T to placebo in subjects assigned to no PRT.||||<0.05
70984258|NCT00112151|141477173|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in fat mass measured by dual x-ray absorptiometry (DXA) with any T to placebo in subjects assigned to PRT.||||<0.05
70984259|NCT00112151|141477173|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in fat mass measured by dual x-ray absorptiometry (DXA) with any T to placebo in subjects assigned to no PRT.||||<0.05
70984260|NCT00112151|141477174|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in fat free mass measured by dual x-ray absorptiometry (DXA) with any T to placebo in subjects assigned to PRT.||||<0.05
70984261|NCT00112151|141477174|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in fat free mass measured by dual x-ray absorptiometry (DXA) with any T to placebo in subjects assigned to no PRT.||||<0.05
70984262|NCT03191396|141477180|NON_INFERIORITY|HbA1c non-inferiority was tested using a non-inferiority margin of 0.3.|Treatment difference|-0.69|||<|0.0001|TWO_SIDED|95.0|-0.82|-0.56||The non-inferiority p-value is calculated as two times the one-sided p-value from a t-distributed test statistic comparing the treatment contrast with 0.3.|ANCOVA||Semaglutide 1.0 mg - Liraglutide 1.2 mg|The responses are analysed using an ANCOVA with treatment and stratification factor as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.||-0.56|-0.82|<0.0001
70984263|NCT03191396|141477180|SUPERIORITY||Treatment difference|-0.69|||<|0.0001|TWO_SIDED|95.0|-0.82|-0.56|||ANCOVA||Semaglutide 1.0 mg - Liraglutide 1.2 mg|||-0.56|-0.82|<0.0001
70984264|NCT03191396|141477181|SUPERIORITY||Treatment difference|-3.83|||<|0.0001|TWO_SIDED|95.0|-4.57|-3.09|||ANCOVA||Semaglutide 1.0 mg - Liraglutide 1.2 mg|||-3.09|-4.57|<0.0001
70984265|NCT01981122|141477274|SUPERIORITY|||||||0.095|||||||Mixed Models Analysis|Repeated Measures||||||.095
70984266|NCT02435173|141477291|SUPERIORITY||Adjusted means difference|-0.24|STANDARD_ERROR_OF_MEAN|0.06||0.0012|TWO_SIDED|95.0|-0.37|-0.11|||ANCOVA|Treatment as a fixed effect and log10 transformed baseline SPD as a covariate.||||-0.11|-0.37|0.0012
70984267|NCT02435173|141477292|SUPERIORITY||Adjusted means difference|40.13|STANDARD_ERROR_OF_MEAN|5.04|<|0.0001|TWO_SIDED|95.0|28.51|51.75|||ANCOVA|Treatment as a fixed effect and baseline as a covariate.||||51.75|28.51|<0.0001
70984268|NCT04328623|141477338|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70984269|NCT01539837|141477340|SUPERIORITY||||||<|0.01||||||calculated|Pairwise comparisons,post-hoc Bonferoni|||||||<0.01
70984270|NCT02747043|141477368|EQUIVALENCE|Clinical equivalence of the primary endpoint will first be demonstrated by comparing the 1-sided 95% lower confidence limit of the RD of ORR by week 28 between ABP 798 and rituximab with a noninferiority margin of -15%. If this is successful, the 1-sided upper 95% confidence limit of the RD of ORR by week 28 will be compared with a nonsuperiority margin of +35.5%.|Risk Difference (RD)|7.7|||||TWO_SIDED|90.0|-1.4|16.8|||||The 2-sided 90% confidence limits of the risk difference (RD) of ORR by week 28 used a generalized linear model adjusted for the stratification factors (geographic region and age group).|||16.8|-1.4|
70984271|NCT02747043|141477368|OTHER||Risk Difference (RD)|7.7|||||TWO_SIDED|95.0|-3.2|18.6||||||||18.6|-3.2|
70984272|NCT02747043|141477369|OTHER||Risk Difference (RD)|0.9|||||TWO_SIDED|90.0|-9.3|11.2||||||The 2-sided 90% confidence limits of the risk difference (RD) of ORR at week 12 used a generalized linear model adjusted for the stratification factors (geographic region and age group).||11.2|-9.3|
71097627|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|0.9|||||TWO_SIDED|95.0|0.43|1.89||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.89|0.43|
71097628|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|0.83|||||TWO_SIDED|95.0|0.42|1.67||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.67|0.42|
71097629|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|0.93|||||TWO_SIDED|95.0|0.4|2.16||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.16|0.40|
71097630|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|7.53|||||TWO_SIDED|95.0|2.86|19.78||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||19.78|2.86|
71097631|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|0.53|||||TWO_SIDED|95.0|0.22|1.31||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.31|0.22|
71097632|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|0.07|||||TWO_SIDED|95.0|0.02|0.21||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.21|0.02|
71097633|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|1.11|||||TWO_SIDED|95.0|0.53|2.3||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.30|0.53|
71097634|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|1.0|||||TWO_SIDED|95.0|0.5|1.97||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.97|0.50|
71097635|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|0.9|||||TWO_SIDED|95.0|0.39|2.07||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.07|0.39|
71097636|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|4.2|||||TWO_SIDED|95.0|2.18|8.09||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||8.09|2.18|
70984273|NCT02747043|141477369|OTHER||Risk Difference (RD)|0.9|||||TWO_SIDED|95.0|-11.3|13.2||||||The 2-sided 95% confidence limits of the risk difference (RD) of ORR at week 12 used a generalized linear model adjusted for the stratification factors (geographic region and age group).||13.2|-11.3|
70984274|NCT02747043|141477375|OTHER|Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.|Risk Difference (RD)|4.0|||||TWO_SIDED|95.0|-8.3|16.3||||||Percentage risk difference for 'Any adverse event of interest'||16.3|-8.3|
70984275|NCT02747043|141477375|OTHER|Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-12.1|12.3||||||Percentage risk difference for 'Infusion reactions including hypersensitivity'||12.3|-12.1|
71097637|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|0.61|||||TWO_SIDED|95.0|0.33|1.13||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.13|0.33|
71097638|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|0.15|||||TWO_SIDED|95.0|0.07|0.31||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.31|0.07|
71097639|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|3.11|||||TWO_SIDED|95.0|1.51|6.4||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||6.40|1.51|
71097640|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|1.88|||||TWO_SIDED|95.0|0.96|3.69||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.69|0.96|
71097641|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|0.6|||||TWO_SIDED|95.0|0.27|1.37||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.37|0.27|
70984276|NCT02747043|141477375|OTHER|Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.|Risk Difference (RD)|0.7|||||TWO_SIDED|95.0|-11.8|13.0||||||Percentage risk difference for 'Hematological reactions'||13.0|-11.8|
70984277|NCT02747043|141477375|OTHER|Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.|Risk Difference (RD)|0.8|||||TWO_SIDED|95.0|-11.8|13.2||||||Percentage risk difference in 'Cardiac disorders'||13.2|-11.8|
71037399|NCT03703258|141581780|SUPERIORITY||Slope|-2.46|STANDARD_ERROR_OF_MEAN|1.63||0.13|TWO_SIDED||||||Mixed Models Analysis||Post-intervention condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to post-intervention only||||.13
71037400|NCT03703258|141581780|SUPERIORITY||Slope|-1.94|STANDARD_ERROR_OF_MEAN|1.64||0.24|TWO_SIDED||||||Mixed Models Analysis||3 month condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to 3 months||||.24
71037401|NCT03703258|141581780|SUPERIORITY||Cohen's D|-0.41|||||TWO_SIDED||||||||Post-intervention between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to post-intervention only||||
71037402|NCT03703258|141581780|SUPERIORITY||Cohen's D|-0.23|||||TWO_SIDED||||||||3 month between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to 3 months||||
71037403|NCT03703258|141581781|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.25||0.85|TWO_SIDED||||||Mixed Models Analysis||Post-intervention condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to post-intervention only||||.85
70984278|NCT02747043|141477375|OTHER|Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.|Risk Difference (RD)|1.6|||||TWO_SIDED|95.0|-10.9|14.0||||||Percentage risk difference in 'Serious infections'||14.0|-10.9|
70984279|NCT02747043|141477375|OTHER|Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.|Risk Difference (RD)|0.8|||||TWO_SIDED|95.0|-11.7|13.2||||||Percentage risk difference in 'Severe mucocutaneous reactions'||13.2|-11.7|
71037404|NCT03703258|141581781|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.25||0.96|TWO_SIDED||||||Mixed Models Analysis||3 month condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to 3 months||||.96
70984280|NCT01629667|141477432|SUPERIORITY_OR_OTHER||Least square mean difference|-1.77||||0.14|TWO_SIDED|95.0|-4.13|0.59|||ANCOVA|||||0.59|-4.13|0.140
70984281|NCT01629667|141477432|SUPERIORITY_OR_OTHER||Least square mean difference|-1.41||||0.234|TWO_SIDED|95.0|-3.73|0.91|||ANCOVA|||||0.91|-3.73|0.234
70984282|NCT03065530|141477484|OTHER||||||<|0.05|||||||Kruskal-Wallis|||The sample size was calculated on the basis of an our initial pilot study, and the SD was 1.4 between the four groups. We hypothesized that the differences in VAS between the four groups and the SDs would be 15%. A power analysis suggested that there will be 80% power to detect differences at an α=0.05 significance level (two-tailed), including 24 individuals per treatment group. Considering the exclusion of 25% of patients, 30 parturients were eventually recruited in each group.||||<0.05
70984283|NCT01512368|141477508|SUPERIORITY_OR_OTHER||Slope|0.089|STANDARD_ERROR_OF_MEAN|0.063|<|0.001|TWO_SIDED|95.0|0.034|0.144||All reported p values are based on two-sided tests considering ≤0.05 as significant.|Regression, Linear|Adjusted for age, time of exercise, creatinine, waist to hip ratio, fat percentage, body mass index, mean rest heart rate, blood pressure.|Metabolic equivalents (METs) consumed were independently associated with the log of delta (final-basal) FGF21 levels.|"FGF21 was log transformed to approximate normality before analyses. Null hypothesis was Ho = Y1 (FGF21 level at baseline) = Y2 (FGF21 level after two weeks of exercising). Power calculation was 80% with 60 participants evaluated (one group). To evaluate the effect of exercise on clinical and biochemical parameters, we used the difference between final - basal levels (delta)."||0.144|0.034|<0.001
70984284|NCT02708212|141477585|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||The two-sample t test will be used to compare the total doses of fentanyl and midazolam between the two study groups.||||<0.0001
70984285|NCT02708212|141477586|SUPERIORITY_OR_OTHER|||||||0.0012|||||||t-test, 2 sided|||The two-sample t test will be used to compare the total doses of midazolam between the two study groups.||||0.0012
70984286|NCT02708212|141477587|SUPERIORITY_OR_OTHER|||||||0.6967|||||||t-test, 2 sided|||||||0.6967
70984287|NCT05341466|141477588|SUPERIORITY||Mean Difference (Net)|0.528|STANDARD_ERROR_OF_MEAN|0.188||0.0098|||||||Mixed Models Analysis|||||||0.0098
71037405|NCT03703258|141581781|SUPERIORITY||Cohen's D|-0.15|||||TWO_SIDED||||||||Post-intervention between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to post-intervention only||||
71037406|NCT03703258|141581781|SUPERIORITY||Cohen's D|0.003|||||TWO_SIDED||||||||3 month between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to 3 months||||
71037407|NCT03703258|141581782|SUPERIORITY||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.26||0.75|TWO_SIDED||||||Mixed Models Analysis||Post-intervention condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to post-intervention only||||.75
71037408|NCT03703258|141581782|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.27||0.64|TWO_SIDED||||||Mixed Models Analysis||3 month condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to 3 months||||.64
71037409|NCT03703258|141581782|SUPERIORITY||Cohen's D|-0.12|||||TWO_SIDED||||||||Post-intervention between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to post-intervention only||||
71037410|NCT03703258|141581782|SUPERIORITY||Cohen's D|-0.16|||||TWO_SIDED||||||||3 month between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to 3 months||||
71037411|NCT03703258|141581783|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.35||0.86|TWO_SIDED||||||Mixed Models Analysis||Post-intervention condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to post-intervention only||||.86
71037412|NCT03703258|141581783|SUPERIORITY||Slope|-0.22|STANDARD_ERROR_OF_MEAN|0.36||0.55|TWO_SIDED||||||Mixed Models Analysis||3 month condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to 3 months||||.55
71037413|NCT03703258|141581783|SUPERIORITY||Cohen's D|-0.04|||||TWO_SIDED||||||||Post-intervention between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to post-intervention only||||
71037414|NCT03703258|141581783|SUPERIORITY||Cohen's D|-0.39|||||TWO_SIDED||||||||3 month between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to 3 months||||
71037415|NCT01248728|141581857|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Mixed Models Analysis|||||||0.5
71037416|NCT01248728|141581858|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Mixed Models Analysis|||||||0.02
71037417|NCT01248728|141581860|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
71037418|NCT01248728|141581861|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|||||||Regression, Linear|||||||0.6
71037419|NCT01838681|141581884|SUPERIORITY||Odds Ratio (OR)|0.83||||0.2641|TWO_SIDED|95.0|0.6|1.15|||Regression, Logistic|Model included MADRS total score at the randomisation visit, treatment group, country, and the randomisation criteria used||||1.15|0.60|0.2641
71037420|NCT01229150|141581904|SUPERIORITY_OR_OTHER|||||||0.24|||||||Log Rank|||||||0.24
71037421|NCT01229150|141581904|SUPERIORITY_OR_OTHER|||||||0.75|||||||Log Rank|||||||0.75
71037422|NCT01229150|141581908|SUPERIORITY_OR_OTHER|||||||0.51|||||||Log Rank|||||||0.51
71037423|NCT01229150|141581908|SUPERIORITY_OR_OTHER|||||||0.81|||||||Log Rank|||||||0.81
71037424|NCT01229150|141581910|SUPERIORITY_OR_OTHER||||||<|0.0007||||||P-value was determined by comparison by the level of p-ERK at cycle 1 day 1 to cycle 1 day 2.|Wilcoxon matched-pairs signed rank test|||||||<0.0007
71037425|NCT01229150|141581910|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value was determined by comparison by the level of p-ERK at cycle 1 day 1 to cycle 1 day 14.|Wilcoxon matched-pairs signed rank test|||||||<0.0001
71037426|NCT01229150|141581910|SUPERIORITY_OR_OTHER|||||||0.0209||||||P-value was determined by comparison by the level of p-ERK at cycle 1 day 2 and cycle 1 day 14.|Wilcoxon matched-pairs signed rank test|||4 patients in this group; statistically underpowered.||||0.0209
71037427|NCT00849797|141581949|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|90.86||||||90.0|85.47|96.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||96.60|85.47|
71037428|NCT00849797|141581950|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.6||||||90.0|96.59|100.66|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100.66|96.59|
71037429|NCT00849797|141581951|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.74||||||90.0|96.71|100.8|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100.80|96.71|
71037430|NCT00849797|141581952|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.5||||||90.0|95.66|100.48|||||Results presented for informational purposes only; metabolite not subjected to bioequivalence criteria.|||100.48|95.66|
71037431|NCT00849797|141581953|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.29||||||90.0|98.96|101.64|||||Results presented for informational purposes only, metabolite not subjected to bioequivalence criteria.|||101.64|98.96|
71037432|NCT00849797|141581954|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.08||||||90.0|98.91|101.27|||||Results presented for informational purposes only; metabolite not subjected to bioequivalence criteria.|||101.27|98.91|
71037433|NCT04198363|141581962|NON_INFERIORITY|Noninferiority of vonoprazan to esomeprazole was evaluated by Farrington and Manning test using a noninferiority margin of 10% for analysis.|Difference in Proportions|0.1|||=|0.0009|TWO_SIDED|95.0|-5.95|6.17|||Farrington and Manning Test||Difference in proportions for vonoprazan versus esomeprazole was analyzed and the 2-sided Wald confidence interval was used for determining the 95% confidence interval.|||6.17|-5.95|=0.0009
70984288|NCT05341466|141477588|OTHER||Adjusted R-squared|0.418||||0.014|||||||Regression, Linear|||Linear regression analyses performed with the change in the MEP amplitude versus step length asymmetry.||||0.014
71097642|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|2.88|||||TWO_SIDED|95.0|1.39|5.98||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||5.98|1.39|
71097643|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|1.15|||||TWO_SIDED|95.0|0.58|2.28||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.28|0.58|
71097644|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|0.4|||||TWO_SIDED|95.0|0.17|0.92||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.92|0.17|
71097645|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|2.57|||||TWO_SIDED|95.0|1.5|4.39||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.39|1.50|
71097646|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|1.24|||||TWO_SIDED|95.0|0.75|2.05||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.05|0.75|
71097647|NCT01026038|141703960|SUPERIORITY_OR_OTHER||GMC ratio|0.48|||||TWO_SIDED|95.0|0.26|0.89||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.89|0.26|
71097648|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT Ratio|0.2|||||TWO_SIDED|95.0|0.04|0.73||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.73|0.04|
71097649|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT Ratio|0.2|||||TWO_SIDED|95.0|0.04|0.64||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.64|0.04|
71097650|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.19|5.46||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||5.46|0.19|
71097651|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.17|5.85||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||5.85|0.17|
71097652|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|0.7|||||TWO_SIDED|95.0|0.15|3.72||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.72|0.15|
71097653|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|0.7|||||TWO_SIDED|95.0|0.1|5.37||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||5.37|0.10|
71097654|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|1.2|||||TWO_SIDED|95.0|0.23|6.25||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||6.25|0.23|
71097655|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.17|3.92||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.92|0.17|
71097656|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|0.7|||||TWO_SIDED|95.0|0.11|4.43||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||4.43|0.11|
71097657|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|2.4|||||TWO_SIDED|95.0|0.48|12.35||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||12.35|0.48|
71097658|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|2.0|||||TWO_SIDED|95.0|0.45|9.05||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||9.05|0.45|
71097659|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.13|5.14||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||5.14|0.13|
71097660|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|0.2|||||TWO_SIDED|95.0|0.04|0.8||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.80|0.04|
70984289|NCT05341466|141477588|OTHER||Adjusted R-squared|0.496||||0.006|||||||Regression, Linear|||Linear regression analyses performed with the change in the MEP amplitude versus step time asymmetry.||||0.006
70984290|NCT05341466|141477588|OTHER||Adjusted R-squared|0.666||||0.001|||||||Regression, Linear|||Linear regression analyses performed with the change in the MEP amplitude versus changes in net metabolic power.||||0.001
70984291|NCT05341466|141477589|SUPERIORITY||Median Difference (Net)|-0.0042|STANDARD_DEVIATION|0.0232||0.744|||||||ANOVA|||||||0.744
71097661|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|0.5|||||TWO_SIDED|95.0|0.12|2.03||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.03|0.12|
70984292|NCT05341466|141477590|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.0231||0.269|||||||ANOVA|||||||0.269
70984293|NCT05341466|141477591|SUPERIORITY||Median Difference (Net)|-0.4|STANDARD_DEVIATION|0.681||0.02|||||||ANOVA|||||||0.020
70984294|NCT01145391|141477615|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence||||||0.5||95.0||||For systolic blood pressure|Mixed Models Analysis|||||||0.50
70984295|NCT03037905|141477627|SUPERIORITY||Mean Difference (Final Values)|-6.7||||0.2|TWO_SIDED|95.0|-17.1|3.7|||Mixed Models Analysis|||||3.7|-17.1|0.20
70984296|NCT03037905|141477628|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.6|TWO_SIDED|95.0|-5.9|10.3|||Mixed Models Analysis|||||10.3|-5.9|0.60
70984297|NCT03037905|141477629|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.76|TWO_SIDED|95.0|-7.0|5.1|||Mixed Models Analysis|||||5.1|-7.0|.76
70984298|NCT03037905|141477630|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||||||.83
70984299|NCT01333189|141477631|SUPERIORITY_OR_OTHER||||||=|0.329|TWO_SIDED||||||Mixed Models Analysis|||||||=0.329
70984300|NCT01333189|141477632|SUPERIORITY_OR_OTHER||||||=|0.891|TWO_SIDED||||||Mixed Models Analysis|||||||=0.891
70984301|NCT01333189|141477633|SUPERIORITY_OR_OTHER||||||=|0.021|TWO_SIDED||||||Mixed Models Analysis|||||||=0.021
70984302|NCT01333189|141477634|SUPERIORITY_OR_OTHER||||||=|0.509|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the hip||||=0.509
70984303|NCT01333189|141477634|SUPERIORITY_OR_OTHER||||||=|0.5|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the knee||||=0.500
70984304|NCT01333189|141477634|SUPERIORITY_OR_OTHER||||||=|0.607|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the ankle||||=0.607
70984305|NCT01333189|141477635|SUPERIORITY_OR_OTHER||||||=|0.068|TWO_SIDED||||||Mixed Models Analysis|||||||=0.068
70984306|NCT01333189|141477636|SUPERIORITY_OR_OTHER||||||=|0.48|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the hip||||=0.480
70984307|NCT01333189|141477636|SUPERIORITY_OR_OTHER||||||=|0.12|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the knee||||=0.120
70984308|NCT01333189|141477636|SUPERIORITY_OR_OTHER||||||=|0.668|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the ankle||||=0.668
70984309|NCT01333189|141477637|SUPERIORITY_OR_OTHER||||||=|0.511|TWO_SIDED||||||Mixed Models Analysis|||||||=0.511
70984310|NCT01333189|141477638|SUPERIORITY_OR_OTHER||||||=|0.402|TWO_SIDED||||||Mixed Models Analysis|||||||=0.402
70984311|NCT01333189|141477639|SUPERIORITY_OR_OTHER||||||=|0.021|TWO_SIDED||||||Mixed Models Analysis|||||||=0.021
70984312|NCT01333189|141477640|SUPERIORITY_OR_OTHER||||||=|0.686|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the hip||||=0.686
70984313|NCT01333189|141477640|SUPERIORITY_OR_OTHER||||||=|0.434|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the knee||||=0.434
70984314|NCT01333189|141477640|SUPERIORITY_OR_OTHER||||||=|0.227|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the ankle||||=0.227
70984315|NCT01333189|141477641|SUPERIORITY_OR_OTHER||||||=|0.068|TWO_SIDED||||||Mixed Models Analysis|||||||=0.068
70984316|NCT01333189|141477642|SUPERIORITY_OR_OTHER||||||=|0.16|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the hip||||=0.160
70984317|NCT01333189|141477642|SUPERIORITY_OR_OTHER||||||=|0.008|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the knee||||=0.008
70984318|NCT01333189|141477642|SUPERIORITY_OR_OTHER||||||=|0.877|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the ankle||||=0.877
70984319|NCT02042131|141477654|SUPERIORITY|||||||0.082|||||||Log Rank|||Omnibus test of all three groups||||.082
70984320|NCT02042131|141477654|SUPERIORITY|||||||0.028|||||||Log Rank|||Planned contrast #1: TAU vs. S-CRP/E-CRP||||.028
70984321|NCT02042131|141477654|SUPERIORITY||Cox Proportional Hazard|0.24||||0.04|TWO_SIDED|95.0|0.06|0.96|||Regression, Cox|||Planned contrast #1: TAU vs. S-CRP/E-CRP||0.96|0.06|.040
70984322|NCT02042131|141477655|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Omnibus test comparing all three groups.||||<0.001
70984323|NCT02042131|141477655|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Planned contrast #1: TAU vs. S-CRP/E-CRP||||<0.001
70984324|NCT02042131|141477656|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Planned contrast #1: TAU vs. S-CRP/E-CRP||||<0.001
70984325|NCT02042131|141477657|SUPERIORITY|||||||0.04|||||||Chi-squared|||Omnibus test of all groups||||0.040
70984326|NCT02042131|141477657|SUPERIORITY||Odds Ratio (OR)|0.1||||0.045|TWO_SIDED|95.0|0.002|0.9|||Chi-squared|||Planned contrast #2: E-CRP vs. TAU/S-CRP||0.9|0.002|0.045
70984327|NCT00377299|141477692|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||Significance was set at a p value of ≤ 0.05.|ANCOVA|||||||0.05
70984328|NCT00377299|141477693|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Significance was set at a p value of ≤ 0.05.|ANCOVA|||||||>0.05
70984329|NCT00377299|141477694|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Significance was set at a p value of ≤ 0.05.|ANCOVA|||||||>0.05
70984330|NCT00377299|141477695|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Significance was set at a p value of ≤ 0.05.|ANCOVA|||||||>0.05
70984331|NCT00377299|141477696|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Significance was set at a p value of ≤ 0.05.|ANCOVA|||||||>0.05
70984332|NCT00035815|141477698|SUPERIORITY_OR_OTHER|||||||0.529||95.0|||||Wilcoxon (Mann-Whitney)|||Analysis of MMT was calculated as a ratio of change from baseline to last follow-up to time to duration until last follow-up. For the patients that died during the study period, the last follow-up time was considered as the time of death with a zero score for MMT measurement. Analysis was performed using intention to treat approach. Comparison of rate of change in MMT scores between the placebo and IGF-1 group was made using two sample t-test or Wilcoxon rank sum test as appropriate.||||0.529
71037434|NCT03442322|141581973|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|1.25||||0.492|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.492
71037435|NCT03442322|141581974|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-0.73||||0.765|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.765
71037436|NCT03442322|141581975|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|0.77||||0.808|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.808
71037437|NCT03442322|141581976|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|3.86||||0.108|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.108
71037438|NCT03442322|141581977|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|2.59||||0.411|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.411
70984333|NCT00035815|141477699|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.04||||0.415|TWO_SIDED|95.0|0.77|1.4|||Regression, Cox|||Patients who elected to proceed to tracheostomy were assessed on the day of their procedure. Subjects who continuously utilized NIPPV for greater than 10 days were assessed as being ventilator-dependent on the first day they began continuous NIPPV. Survival between groups was compared using the Cox-proportional Hazards model.||1.4|0.77|0.415
70984334|NCT00035815|141477700|SUPERIORITY_OR_OTHER|||||||0.321||95.0|||||Wilcoxon (Mann-Whitney)|||The final secondary outcome measure was the rate of change in the ALSFRS-r score. The ALSFRS-r was completed at each visit (randomization and then at 3, 6, 12, 18 and 24 months post-randomization). As with the MMT scores a score of 0 was imputed on the day of death. Analysis of the ALSFRS-r scores as a secondary outcome was performed in similar manner as MMT score.||||0.321
70984335|NCT03165981|141477701|SUPERIORITY||Risk Ratio (RR)|0.87||||0.7588|TWO_SIDED|95.0|0.36|2.1|||Mantel Haenszel|Mantel Haenzel is stratified by site.|RR is adjusted by site.|||2.10|0.36|0.7588
70984336|NCT03165981|141477702|SUPERIORITY||Risk Ratio (RR)|0.97||||0.9412|TWO_SIDED|95.0|0.39|2.4|||Mantel Haenszel|Mantel Haenzel is stratified by site.|RR is adjusted by site.|||2.40|0.39|.9412
70984337|NCT03165981|141477703|SUPERIORITY|||||||0.3408|||||||Mantel Haenszel|Mantel Haenzel is stratified by site.||||||0.3408
70984338|NCT03165981|141477704|SUPERIORITY||Risk Ratio (RR)|0.87||||0.8325|TWO_SIDED|95.0|0.24|3.13|||Mantel Haenszel|Mantel Haenzel is stratified by site.|RR is adjusted by site.|||3.13|0.24|0.8325
70984339|NCT03165981|141477705|SUPERIORITY|||||||0.3408|||||||Mantel Haenszel|Mantel Haenzel is stratified by site.||||||0.3408
70984340|NCT03165981|141477706|SUPERIORITY||Risk Ratio (RR)|0.73||||0.6101|TWO_SIDED|95.0|0.21|2.48|||Mantel Haenszel|Mantel Haenzel is stratified by site.|RR is adjusted by site.|||2.48|0.21|0.6101
70984341|NCT03165981|141477707|SUPERIORITY|||||||0.848|||||||Wilcoxon (Mann-Whitney)|||||||0.848
70984342|NCT03165981|141477709|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
70984343|NCT01894516|141477713|SUPERIORITY||Difference in percentage rates|37.5|||<|0.0001|TWO_SIDED|95.0|22.4|52.6||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||52.6|22.4|< 0.0001
70984344|NCT01894516|141477713|SUPERIORITY||Difference in percentage rates|36.5|||<|0.0001|TWO_SIDED|95.0|21.3|51.8||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||51.8|21.3|< 0.0001
70984345|NCT01894516|141477713|SUPERIORITY||Difference in percentage rates|43.3|||<|0.0001|TWO_SIDED|95.0|28.4|58.2||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||58.2|28.4|< 0.0001
70984346|NCT03270085|141477724|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
70984347|NCT03270085|141477725|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||||||0.81
70984348|NCT03270085|141477726|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
70984349|NCT00417612|141477732|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|TWO_SIDED||||||ANOVA|||||||0.007
70984350|NCT01330381|141477741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9002|||||||Cochran-Mantel-Haenszel|||||||0.9002
70984351|NCT01330381|141477742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.352|||||||Cochran-Mantel-Haenszel|||||||0.3520
70984352|NCT01330381|141477743|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5228|||||||Cochran-Mantel-Haenszel|||||||0.5228
70984353|NCT01330381|141477752|SUPERIORITY_OR_OTHER_LEGACY|||||||0.377|||||||Chi-squared|||||||0.377
70984354|NCT01330381|141477755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1599|||||||Van Elteren test|||||||0.1599
70984355|NCT01330381|141477756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||Van Elteren test|||||||0.0003
70984356|NCT01330381|141477757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4647|||||||Van Elteren test|||||||0.4647
70984357|NCT01330381|141477758|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren test|||||||<0.0001
70984358|NCT01330381|141477759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3044|||||||Van Elteren test|||||||0.3044
70984359|NCT00663858|141477760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.592|STANDARD_ERROR_OF_MEAN|0.662||0.371|TWO_SIDED|95.0|-1.894|0.709|||ANOVA|||||0.709|-1.894|0.371
70984360|NCT00663858|141477760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.711|STANDARD_ERROR_OF_MEAN|0.722||0.3253|TWO_SIDED|95.0|-709.0|2.132|||ANCOVA|||||2.132|-0709|0.3253
71037439|NCT03442322|141581978|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-0.08||||0.981|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.981
70984361|NCT00663858|141477760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.324|STANDARD_ERROR_OF_MEAN|0.62||0.0333|TWO_SIDED|95.0|-2.542|-0.106|||ANCOVA|||||-0.106|-2.542|0.0333
70984362|NCT03216265|141477761|OTHER||Least Square Mean difference|-1.44|||<|0.0001|TWO_SIDED|95.0|-2.1|-0.78|||ANCOVA|Analysis model (ANCOVA) included participant as random effect, treatment arm and side of body as fixed effects, and baseline value as covariate.|Difference is the first named treatment adjusted (LS) mean change from baseline (Visit 2) minus the second named treatment adjusted mean change from baseline (Visit 2).|||-0.78|-2.10|<0.0001
70984363|NCT02988986|141477785|SUPERIORITY|Based on prior data for Ki67 changes in the tamoxifen arm alone, we will assume null hypothesis and alternative hypotheses of 60% and 80% reduction in Ki67, respectively. A sample of 25 patients will provide 86% power to detect the hypothesized reduction in Ki67 with 5% alpha based on a two-sided, one sample t-test of mean percent change in Ki67 level.|||||=|0.0023|||||||Wilcoxon (Mann-Whitney)|||The primary endpoint was the change in Ki67 after 6 weeks of treatment.||||=0.0023
70984364|NCT00685178|141477794|SUPERIORITY||F-value for main effect of Condition|2.21||||0.531|TWO_SIDED|||||Using the proportion of negative urine samples obtained, the four groups were compared to determine whether there are any group differences in cocaine abstinence (as measured by negative urine samples).|Chi-squared||F-value for main effect of Drug Condition|||||0.531
70984365|NCT00685178|141477795|SUPERIORITY||Spearmann's rank correlation|0.969|||<|0.001|TWO_SIDED||||||ANOVA||CR subjects only|Analyses were performed to measure the correlation between CR groups (topiramate + CR and Placebo + CR) and abstinence.||||<0.001
70984366|NCT00685178|141477795|SUPERIORITY||Spearmann's rank correlation|0.494|||<|0.001|TWO_SIDED||||||Generalized Estimating Equation (GEE)||NonCR subjects only|Analyses were performed to measure the correlation between Non-CR groups (topiramate + NonCR and Placebo + NonCR) and abstinence.||||<0.001
70984367|NCT00077623|141477796|NON_INFERIORITY_OR_EQUIVALENCE|The two RO0503821 dosing schedules were compared separately to epoetin reference using ANCOVA, with Hb at BL and region as the covariates. The test for non-inferiority were based on the lower limit of the two-sided 97.5% confidence interval for the difference between the two groups. When the lower limit was greater than or equal to -0.75 g/dL, the RO0503821 groups were regarded as non-inferior to the epoetin reference group. The confidence level of 97.5% was chosen to adjust for multiplicity.|Mean Difference between groups|0.141|||<|0.0001|TWO_SIDED|97.5|-0.098|0.38||The p-value for the non-inferiority test can be derived via the t-test.|ANCOVA, CI for difference between groups|||The non-inferiority test for treatment differences in Hb change from baseline, based on ANCOVA analysis with a non-inferiority limit of -0.75 g/dL (Per Protocol Population)||0.380|-0.098|<0.0001
71037440|NCT03442322|141581979|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|3.51||||0.02|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.020
70984368|NCT00077623|141477796|NON_INFERIORITY_OR_EQUIVALENCE|The two RO0503821 dosing schedules were compared separately to epoetin reference using ANCOVA, with Hb at BL and region as the covariates. The test for non-inferiority were based on the lower limit of the two-sided 97.5% confidence interval for the difference between the two groups. When the lower limit was greater than or equal to -0.75 g/dL, the RO0503821 groups were regarded as non-inferior to the epoetin reference group. The confidence level of 97.5% was chosen to adjust for multiplicity .|Mean Difference between groups|-0.022|||<|0.0001|TWO_SIDED|97.5|-0.262|0.217||The p-value for the non-inferiority test can be derived via the t-test.|ANCOVA, CI for difference between groups|||The non-inferiority test for treatment differences in Hb change from baseline, based on ANCOVA analysis with a non-inferiority limit of -0.75 g/dL (Per Protocol Population)||0.217|-0.262|<0.0001
70984369|NCT00401973|141477828|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||P-value for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|Mixed Models Analysis|Repeated Measures Analysis||To detect a difference between treatment arms of 3.06 kg in mean weight change from baseline to endpoint, 150 patients must be enrolled in stepped intervention arm and 50 in control arm. Assuming a standard deviation of 6.87 kg, there is 80% power to detect a difference between treatment arms on a 1-sided 2-sample t-test at the 5% significance level. Primary analysis was the comparison of mean weight change for 'olanzapine only' versus pooled 'olanzapine \& adjunctive treatment' arm at Week 22.||||0.065
70984370|NCT00401973|141477828|SUPERIORITY_OR_OTHER|||||||0.113||95.0|||||Mixed Models Analysis|Repeated Measures Analysis||Hypothesis=weight gain associated with olanzapine can be prevented or mitigated with an adjunctive pharmacological algorithm.||||0.113
70984371|NCT00401973|141477828|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||Mixed Models Analysis|Repeated Measures Analysis||||||0.036
70984372|NCT00401973|141477829|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.498
70984373|NCT00401973|141477829|SUPERIORITY_OR_OTHER|||||||0.637||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.637
70984374|NCT00401973|141477829|SUPERIORITY_OR_OTHER|||||||0.125||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.125
70984375|NCT00401973|141477830|SUPERIORITY_OR_OTHER|||||||0.173||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.173
70984376|NCT00401973|141477830|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.016
70984377|NCT00401973|141477830|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.029
70984378|NCT00401973|141477831|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.017
70984379|NCT00401973|141477831|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.015
70984380|NCT00401973|141477831|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.071
70984381|NCT00401973|141477832|SUPERIORITY_OR_OTHER|||||||0.152||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.152
70984382|NCT00401973|141477832|SUPERIORITY_OR_OTHER|||||||0.35||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.350
70984383|NCT00401973|141477832|SUPERIORITY_OR_OTHER|||||||0.123||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.123
70984384|NCT00401973|141477833|SUPERIORITY_OR_OTHER|||||||0.499||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.499
70984385|NCT00401973|141477833|SUPERIORITY_OR_OTHER|||||||0.833||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.833
70984386|NCT00401973|141477833|SUPERIORITY_OR_OTHER|||||||0.339||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.339
71037441|NCT03442322|141581980|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|1.62||||0.299|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.299
71037442|NCT03442322|141581981|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|1.68||||0.389|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.389
71037443|NCT03442322|141581982|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-2.14||||0.389|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.389
71097662|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|2.7|||||TWO_SIDED|95.0|0.48|14.92||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||14.92|0.48|
71097663|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.23|4.36||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.36|0.23|
70984387|NCT00401973|141477834|SUPERIORITY_OR_OTHER|||||||0.278||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.278
70984388|NCT00401973|141477834|SUPERIORITY_OR_OTHER|||||||0.976||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.976
70984389|NCT00401973|141477834|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.049
70984390|NCT00401973|141477835|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.122
70984391|NCT00401973|141477835|SUPERIORITY_OR_OTHER|||||||0.225||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.225
70984392|NCT00401973|141477835|SUPERIORITY_OR_OTHER|||||||0.124||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.124
70984393|NCT00401973|141477836|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.020
70984394|NCT00401973|141477836|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||P-value for Change from Baseline|ANCOVA|||||||0.037
70984395|NCT00401973|141477836|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.038
70984396|NCT00401973|141477837|SUPERIORITY_OR_OTHER|||||||0.474||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.474
70984397|NCT00401973|141477837|SUPERIORITY_OR_OTHER|||||||0.404||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.404
70984398|NCT00401973|141477837|SUPERIORITY_OR_OTHER|||||||0.652||95.0||||P-value for Change from Baseline|ANCOVA|||||||0.652
70984399|NCT01954628|141477870|SUPERIORITY_OR_OTHER||Least sqaure mean difference|23.7||||0.759|TWO_SIDED|95.0|-128.3|175.7||AAC were compared between treatments using an analysis of variance model adjusting for treatment and region as factors and including the baseline score as a covariate.|ANOVA|||Sample size based on area above the daily EXACT score curve (AAC) from Day 1 to Day 29 from subjects with an acute COPD exacerbation, collected over 28 days. Assuming a residual SD of 500 points, a sample size of 200 subjects per arm would be expected to have an 80% power to detect a true treatment difference in the AAC of 140 points over 12-weeks treatment, using a 2-sided test; alpha-level of 0.05.This difference corresponds to a mean daily improvement of 1.67 points on the EXACT symptom score||175.7|-128.3|0.759
70984400|NCT01954628|141477871|SUPERIORITY_OR_OTHER||Least sqaure mean difference|-0.34||||0.588|TWO_SIDED|95.0|-1.57|0.89|||ANOVA|||ANOVA model with fixed factors treatment, region and baseline total CAT score as covariate were used. Missing post-treatment data were imputed using the Last Observation Carried Forward principle.||0.89|-1.57|0.588
70984401|NCT01954628|141477872|SUPERIORITY_OR_OTHER||Least sqaure mean difference|1.083||||0.646|TWO_SIDED|95.0|0.771|1.52|||Negative binomial regression model|Negative binomial regression model with fixed factors treatment, region and time in study as offset.||The number of subjects with at least one COPD exacerbation were summarised by treatment group.||1.520|0.771|0.646
70984402|NCT01954628|141477875|SUPERIORITY_OR_OTHER|||||||0.226|||||||ANOVA|||Missing post-treatment data was imputed using the Last Observation Carried Forward principle.||||0.226
70984403|NCT01650779|141477884|SUPERIORITY_OR_OTHER|||||||0.0002|||||||One sample t-test|||Baseline versus Month 2: Analysis was performed using one sample t-test.||||0.0002
70984404|NCT01650779|141477884|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||Baseline versus Month 4: Analysis was performed using one sample t-test.||||<0.0001
70984405|NCT01650779|141477884|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||Baseline versus Month 6: Analysis was performed using one sample t-test.||||<0.0001
70984406|NCT01650779|141477885|SUPERIORITY_OR_OTHER|||||||0.1178|||||||One sample t-test|||Baseline versus Month 2: Analysis was performed using one sample t-test.||||0.1178
71037444|NCT03442322|141581983|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-5.95||||0.043|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.043
71037445|NCT03442322|141581984|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-3.91||||0.279|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.279
71037446|NCT03442322|141581985|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|0.92||||0.728|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.728
71037447|NCT03442322|141581986|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-1.75||||0.49|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.490
71037448|NCT03442322|141581987|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|4.44||||0.232|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.232
71037449|NCT03442322|141581988|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|1.11||||0.708|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.708
71037450|NCT03442322|141581989|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|1.0||||0.775|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.775
71037451|NCT03442322|141581990|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|1.77||||0.584|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.584
71037452|NCT03442322|141581991|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-0.25||||0.898|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.898
71037453|NCT03442322|141581992|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-2.79||||0.217|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.217
71037454|NCT03442322|141581993|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-1.39||||0.56|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.560
71037455|NCT03442322|141581994|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-3.08||||0.277|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.277
71037456|NCT03442322|141581995|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-2.53||||0.4|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.400
71037457|NCT03442322|141581996|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-3.18||||0.303|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.303
71037458|NCT01404988|141581997|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED|||||For this pilot study, the Type 1 error was set at 5%|Wilcoxon (Mann-Whitney)|||||||0.1
71037459|NCT01404988|141581997|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.2
71037460|NCT01404988|141581998|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED|||||For this pilot study, the type 1 error was set at 5%|Wilcoxon (Mann-Whitney)|||||||.3
71037461|NCT01404988|141581998|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.77
71037462|NCT01404988|141581999|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||For this pilot study, the type 1 error was set at 5%|Wilcoxon (Mann-Whitney)|||||||0.03
71037463|NCT01404988|141581999|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.06
71037464|NCT01404988|141582000|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED|||||For this pilot study, type 1 error was set at 5%|Fisher Exact|||||||0.60
71037465|NCT01404988|141582000|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Fisher Exact|||||||0.16
71037466|NCT02997176|141582031|OTHER|Bioequivalence|Percent Ratio of Geometric Means|142.19|||||TWO_SIDED|90.0|79.92|252.98||||||AUC0-24 was natural log-transformed and analyzed using an analysis of variance (ANOVA) model with hepatic function group as a fixed effect.||252.98|79.92|
71037467|NCT02997176|141582031|OTHER|Bioequivalence|Percent Ratio of Geometric Means|110.54|||||TWO_SIDED|90.0|54.58|223.85||||||AUC0-24 was natural log-transformed and analyzed using an analysis of variance (ANOVA) model with hepatic function group as a fixed effect.||223.85|54.58|
70984407|NCT01650779|141477885|SUPERIORITY_OR_OTHER|||||||0.1176|||||||One sample t-test|||Baseline versus Month 4: Analysis was performed using one sample t-test.||||0.1176
70984408|NCT01650779|141477885|SUPERIORITY_OR_OTHER|||||||0.0322|||||||One sample t-test|||Baseline versus Month 6: Analysis was performed using one sample t-test.||||0.0322
70984409|NCT01650779|141477886|SUPERIORITY_OR_OTHER|||||||0.5811|||||||One sample test of median (sign test)|||Baseline versus Month 2: Analysis was performed using one sample test of median (sign test). The percent change and absolute change from baseline in urine GL-3 levels were not normally distributed and thus medians were evaluated.||||0.5811
70984410|NCT01650779|141477886|SUPERIORITY_OR_OTHER|||||||0.7744|||||||One sample test of median (sign test)|||Baseline versus Month 4: Analysis was performed using one sample test of median (sign test). The percent change and absolute change from baseline in urine GL-3 levels were not normally distributed and thus medians were evaluated.||||0.7744
70984411|NCT01650779|141477886|SUPERIORITY_OR_OTHER|||||||0.3877|||||||One sample test of median (sign test)|||Baseline versus Month 6: Analysis was performed using one sample test of median (sign test). The percent change and absolute change from baseline in urine GL-3 levels were not normally distributed and thus medians were evaluated.||||0.3877
70984412|NCT00283712|141477901|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||1|TWO_SIDED|90.0|-0.22|0.22|||Fisher Exact|||The study goals were to gather evidence of safety and possible efficacy of infliximab for treatment of pemphigus vulgaris (PV). The analyses focused on estimation rather than hypothesis testing; therefore, there was not sufficient power to detect plausible treatment differences unless they were very large. The sample size reflects a balance between the desire to meet study goals and to expose as few participants as possible until the safety of infliximab for treatment of PV has been clarified.||0.22|-0.22|1.00
70984413|NCT00283712|141477901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||1|TWO_SIDED|90.0|0.02|42.67|||Fisher Exact|||||42.67|0.02|1.00
70984414|NCT00283712|141477902|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1|||||TWO_SIDED|90.0|-0.26|0.06||||||||0.06|-0.26|
70984415|NCT00283712|141477903|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.02||||1|TWO_SIDED|90.0|-0.31|0.36||All secondary analyses are considered supplemental supportive analyses|Fisher Exact|||The primary endpoint analysis was replicated using the per-protocol population.||0.36|-0.31|1.00
70984416|NCT00283712|141477903|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||1|TWO_SIDED|90.0|0.02|38.35||All secondary analyses are considered supplemental supportive analyses|Fisher Exact|||The primary endpoint analysis was replicated using the per-protocol population.||38.35|0.02|1.00
70984417|NCT00283712|141477904|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.2||||0.65|TWO_SIDED|90.0|-0.15|0.55|||Fisher Exact|||||0.55|-0.15|0.65
70984418|NCT00283712|141477904|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.65|TWO_SIDED|90.0|0.06|2.79|||Fisher Exact|||||2.79|0.06|0.650
70984419|NCT00283712|141477914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|90.0|-0.3|0.3|||Fisher Exact|||||0.3|-0.3|1.00
70984420|NCT04329923|141477917|SUPERIORITY||Cox Proportional Hazard|0.58||||0.28|TWO_SIDED||||||Regression, Cox|||||||0.28
70984421|NCT01272180|141477922|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of ABCWY+OMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+OMV - ACWY)|16.0|||||TWO_SIDED|95.0|5.0|29.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup A of two doses of MenABCWY combination vaccine to that of one dose of MenACWY vaccine.||29|5|
71008790|NCT02055976|141525255|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.35298|STANDARD_ERROR_OF_MEAN|0.13609|<|0.001|TWO_SIDED|95.0|-1.62324|-1.08271|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.08271|-1.62324|<0.001
71008791|NCT02055976|141525255|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.79615|STANDARD_ERROR_OF_MEAN|0.1379|<|0.001|TWO_SIDED|95.0|-2.07001|-1.52229|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.52229|-2.07001|<0.001
71008792|NCT02055976|141525255|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.86921|STANDARD_ERROR_OF_MEAN|0.13927|<|0.001|TWO_SIDED|95.0|-2.14575|-1.59266|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.59266|-2.14575|<0.001
71008793|NCT02055976|141525255|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.57311|STANDARD_ERROR_OF_MEAN|0.14333|<|0.001|TWO_SIDED|95.0|-1.85788|-1.28834|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.28834|-1.85788|<0.001
71008794|NCT02055976|141525255|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.00256|STANDARD_ERROR_OF_MEAN|0.14228|<|0.001|TWO_SIDED|95.0|-2.28521|-1.7199|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.71990|-2.28521|<0.001
70984422|NCT01272180|141477922|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of ABCWY+OMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between MenABCWY and MenACWY groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+OMV - ACWY)|32.0|||||TWO_SIDED|95.0|21.0|44.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup C of two doses of ABCWY+OMV combination vaccine to that of one dose of MenACWY vaccine.||44|21|
70984423|NCT01272180|141477922|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of ABCWY+OMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+OMV - ACWY)|15.0|||||TWO_SIDED|95.0|0.0|30.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup W-135 of two doses of ABCWY+OMV combination vaccine to that of one dose of MenACWY vaccine.||30|0|
70984424|NCT01272180|141477922|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of ABCWY+OMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+OMV - ACWY)|18.0|||||TWO_SIDED|95.0|5.0|31.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup Y of two doses MenABCWY combination vaccine to that of one dose of MenACWY vaccine.||31|5|
70984425|NCT01272180|141477922|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of MenABCWY+qOMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+qOMV - ACWY)|18.0|||||TWO_SIDED|95.0|7.0|30.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup A of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine.||30|7|
70984426|NCT01272180|141477922|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of MenABCWY+qOMV group was considered to be non-inferior to that of MenACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+qOMV - ACWY)|30.0|||||TWO_SIDED|95.0|18.0|42.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup C of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine.||42|18|
70984427|NCT01272180|141477922|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of MenABCWY+qOMV group was considered to be non-inferior to that of MenACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+qOMV - ACWY)|19.0|||||TWO_SIDED|95.0|4.0|33.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup W-135 of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine.||33|4|
71037468|NCT02997176|141582032|OTHER|Bioequivalence|Percent Ratio of Geometric Means|109.76|||||TWO_SIDED|90.0|70.93|169.84||||||Cmax was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||169.84|70.93|
71037469|NCT02997176|141582032|OTHER|Bioequivalence|Percent Ratio of Geometric Means|131.67|||||TWO_SIDED|90.0|77.14|224.74||||||Cmax was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||224.74|77.14|
70984428|NCT01272180|141477922|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of MenABCWY+qOMV group was considered to be non-inferior to that of MenACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days.|Group Difference % (ABCWY+qOMV - ACWY)|15.0|||||TWO_SIDED|95.0|3.0|29.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup Y of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine.||29|3|
70984429|NCT01183858|141477933|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.671|TWO_SIDED|95.0|0.83|1.33||Unstratified analysis.|Log Rank|||||1.33|0.83|0.671
70984430|NCT01183858|141477939|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.625|TWO_SIDED|95.0|0.84|1.33|||Log Rank|||||1.33|0.84|0.625
70984431|NCT00641147|141477954|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
70984432|NCT00641147|141477954|SUPERIORITY|||||||0.57|||||||ANCOVA|||||||0.57
70984433|NCT00641147|141477955|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||||||0.76
70984434|NCT00641147|141477956|SUPERIORITY|||||||0.85|||||||Chi-squared|||||||0.85
70984435|NCT00641147|141477957|SUPERIORITY|||||||0.16|||||||Chi-squared|||||||0.16
70984436|NCT00641147|141477958|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
70984437|NCT00641147|141477959|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||||||0.63
70984438|NCT00641147|141477960|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
70984439|NCT00641147|141477961|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||||||0.63
70984440|NCT00641147|141477962|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||||||0.93
71037470|NCT02997176|141582033|OTHER|Bioequivalence|Percent Ratio of Geometric Means|149.39|||||TWO_SIDED|90.0|91.49|243.93||||||AUC0-24u was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||243.93|91.49|
70984441|NCT00641147|141477963|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
70984442|NCT00641147|141477964|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
70984443|NCT00641147|141477965|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
70984444|NCT00641147|141477969|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
70984445|NCT01380093|141477977|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.9|||<|0.0001|TWO_SIDED|95.0|-31.7|-18.1||p-value adjusted for multiple comparisons with Hochberg adjustment. At least one primary outcome for each of drug liking and high was required to be significant with adjusted p-value less than or equal to 0.05.|Mixed Models Analysis|||Least square (LS) mean and 95% confidence interval (CI) were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-18.1|-31.7|<0.0001
70984446|NCT01380093|141477977|SUPERIORITY_OR_OTHER||LS Mean Difference|11.9||||0.0009|TWO_SIDED|95.0|5.1|18.6||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||18.6|5.1|0.0009
70984447|NCT01380093|141477977|SUPERIORITY_OR_OTHER||LS Mean Difference|36.8|||<|0.0001|TWO_SIDED|95.0|30.0|43.6||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||43.6|30.0|<0.0001
70984448|NCT01380093|141477978|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.7|||<|0.0001|TWO_SIDED|95.0|-20.2|-11.1||p-value adjusted for multiple comparisons with Hochberg adjustment. At least one primary outcome for each of drug liking and high was required to be significant with adjusted p-value less than or equal to 0.05.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence. Planned power of at least 89% assumed a mean difference of 15 to 30 points and a standard deviation of paired differences of 15 to 20 points, with conservative multiple comparison adjustment for alpha of 0.025.||-11.1|-20.2|<0.0001
70984449|NCT01380093|141477978|SUPERIORITY_OR_OTHER||LS Mean Difference|13.4|||<|0.0001|TWO_SIDED|95.0|8.9|18.0||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||18.0|8.9|<0.0001
70984450|NCT01380093|141477978|SUPERIORITY_OR_OTHER||LS Mean Difference|29.1|||<|0.0001|TWO_SIDED|95.0|24.6|33.7||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||33.7|24.6|<0.0001
70984451|NCT01380093|141477979|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.1|||<|0.0001|TWO_SIDED|95.0|-61.2|-41.0||p-value adjusted for multiple comparisons with Hochberg adjustment. At least one primary outcome for each of drug liking and high was required to be significant with adjusted p-value less than or equal to 0.05.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-41.0|-61.2|<0.0001
70984452|NCT01380093|141477979|SUPERIORITY_OR_OTHER||LS Mean Difference|24.6|||<|0.0001|TWO_SIDED|95.0|14.5|34.6||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||34.6|14.5|<0.0001
70984453|NCT01380093|141477979|SUPERIORITY_OR_OTHER||LS Mean Difference|75.7|||<|0.0001|TWO_SIDED|95.0|65.6|85.8||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||85.8|65.6|<0.0001
70984454|NCT01380093|141477980|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.9|||<|0.0001|TWO_SIDED|95.0|-11.8|-6.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-6.0|-11.8|<0.0001
70984455|NCT01380093|141477980|SUPERIORITY_OR_OTHER||LS Mean Difference|5.2||||0.0006|TWO_SIDED|95.0|2.3|8.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||8.1|2.3|0.0006
70984456|NCT01380093|141477980|SUPERIORITY_OR_OTHER||LS Mean Difference|14.1|||<|0.0001|TWO_SIDED|95.0|11.2|17.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||17.0|11.2|<0.0001
70984457|NCT01380093|141477981|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.8|||<|0.0001|TWO_SIDED|95.0|-62.0|-35.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-35.5|-62.0|<0.0001
70984458|NCT01380093|141477981|SUPERIORITY_OR_OTHER||LS Mean Difference|29.0|||<|0.0001|TWO_SIDED|95.0|15.8|42.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||42.3|15.8|<0.0001
70984459|NCT01380093|141477981|SUPERIORITY_OR_OTHER||LS Mean Difference|77.8|||<|0.0001|TWO_SIDED|95.0|64.5|91.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||91.0|64.5|<0.0001
70984460|NCT01380093|141477982|SUPERIORITY_OR_OTHER||LS Mean Difference|-68.6|||<|0.0001|TWO_SIDED|95.0|-95.0|-42.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-42.2|-95.0|<0.0001
70984461|NCT01380093|141477982|SUPERIORITY_OR_OTHER||LS Mean Difference|56.5|||<|0.0001|TWO_SIDED|95.0|30.1|82.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||82.8|30.1|<0.0001
70984462|NCT01380093|141477982|SUPERIORITY_OR_OTHER||LS Mean Difference|125.1|||<|0.0001|TWO_SIDED|95.0|98.7|151.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||151.5|98.7|<0.0001
70984463|NCT01380093|141477983|SUPERIORITY_OR_OTHER||LS Mean Difference|-76.0||||0.0001|TWO_SIDED|95.0|-112.8|-39.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-39.2|-112.8|0.0001
70984464|NCT01380093|141477983|SUPERIORITY_OR_OTHER||LS Mean Difference|66.5||||0.0006|TWO_SIDED|95.0|29.8|103.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||103.2|29.8|0.0006
71037471|NCT02997176|141582033|OTHER|Bioequivalence|Percent Ratio of Geometric Means|111.04|||||TWO_SIDED|90.0|60.91|202.43||||||AUC0-24u was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||202.43|60.91|
71037472|NCT02997176|141582034|OTHER|Bioequivalence|Percent Ratio of Geometric Means|115.32|||||TWO_SIDED|90.0|77.95|170.6||||||Cmaxu was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||170.6|77.95|
70984465|NCT01380093|141477983|SUPERIORITY_OR_OTHER||LS Mean Difference|142.5|||<|0.0001|TWO_SIDED|95.0|105.7|179.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||179.3|105.7|<0.0001
70984466|NCT01380093|141477984|SUPERIORITY_OR_OTHER||LS Mean Difference|-86.2||||0.0011|TWO_SIDED|95.0|-136.5|-35.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-35.9|-136.5|0.0011
70984467|NCT01380093|141477984|SUPERIORITY_OR_OTHER||LS Mean Difference|69.8||||0.0071|TWO_SIDED|95.0|19.7|120.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||120.0|19.7|0.0071
70984468|NCT01380093|141477984|SUPERIORITY_OR_OTHER||LS Mean Difference|156.0|||<|0.0001|TWO_SIDED|95.0|105.7|206.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||206.3|105.7|<0.0001
70984469|NCT01380093|141477985|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0||||0.1254|TWO_SIDED|95.0|-0.6|4.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.7|-0.6|0.1254
70984470|NCT01380093|141477985|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0||||0.4592|TWO_SIDED|95.0|-3.6|1.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.6|-3.6|0.4592
70984471|NCT01380093|141477985|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.0||||0.0251|TWO_SIDED|95.0|-5.6|-0.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-0.4|-5.6|0.0251
70984472|NCT01380093|141477986|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.4|||<|0.0001|TWO_SIDED|95.0|-19.9|-11.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-11.0|-19.9|<0.0001
70984473|NCT01380093|141477986|SUPERIORITY_OR_OTHER||LS Mean Difference|9.3|||<|0.0001|TWO_SIDED|95.0|4.8|13.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||13.7|4.8|<0.0001
70984474|NCT01380093|141477986|SUPERIORITY_OR_OTHER||LS Mean Difference|24.7|||<|0.0001|TWO_SIDED|95.0|20.3|29.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||29.1|20.3|<0.0001
70984475|NCT01380093|141477987|SUPERIORITY_OR_OTHER||LS Mean Difference|-116.1|||<|0.0001|TWO_SIDED|95.0|-136.5|-95.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-95.7|-136.5|<0.0001
71037473|NCT02997176|141582034|OTHER|Bioequivalence|Percent Ratio of Geometric Means|132.26|||||TWO_SIDED|90.0|81.87|213.67||||||Cmaxu was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||213.67|81.87|
71037474|NCT02997176|141582035|OTHER|Bioequivalence|Percent Ratio of Geometric Means|124.4|||||TWO_SIDED|90.0|85.19|181.66||||||AUC0-24 was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||181.66|85.19|
70984476|NCT01380093|141477987|SUPERIORITY_OR_OTHER||LS Mean Difference|59.7|||<|0.0001|TWO_SIDED|95.0|39.3|80.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||80.1|39.3|<0.0001
70984477|NCT01380093|141477987|SUPERIORITY_OR_OTHER||LS Mean Difference|175.8|||<|0.0001|TWO_SIDED|95.0|155.4|196.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||196.2|155.4|<0.0001
70984478|NCT01380093|141477988|SUPERIORITY_OR_OTHER||LS Mean Difference|-202.2|||<|0.0001|TWO_SIDED|95.0|-239.0|-165.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-165.3|-239.0|<0.0001
70984479|NCT01380093|141477988|SUPERIORITY_OR_OTHER||LS Mean Difference|122.5|||<|0.0001|TWO_SIDED|95.0|85.7|159.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||159.2|85.7|<0.0001
70984480|NCT01380093|141477988|SUPERIORITY_OR_OTHER||LS Mean Difference|324.6|||<|0.0001|TWO_SIDED|95.0|287.7|361.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||361.5|287.7|<0.0001
70984481|NCT01380093|141477989|SUPERIORITY_OR_OTHER||LS Mean Difference|-253.0|||<|0.0001|TWO_SIDED|95.0|-301.5|-204.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-204.5|-301.5|<0.0001
71037475|NCT02997176|141582035|OTHER|Bioequivalence|Percent Ratio of Geometric Means|113.42|||||TWO_SIDED|90.0|73.9|174.07||||||AUC0-24 was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||174.07|73.90|
71037476|NCT02997176|141582035|OTHER|Bioequivalence|Percent Ratio of Geometric Means|95.68|||||TWO_SIDED|90.0|67.9|134.83||||||AUC0-24 was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||134.83|67.90|
71097664|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|1.2|||||TWO_SIDED|95.0|0.31|4.84||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||4.84|0.31|
71097665|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|1.2|||||TWO_SIDED|95.0|0.23|6.65||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||6.65|0.23|
71097666|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.17|4.17||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.17|0.17|
70984482|NCT01380093|141477989|SUPERIORITY_OR_OTHER||LS Mean Difference|151.9|||<|0.0001|TWO_SIDED|95.0|103.5|200.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||200.2|103.5|<0.0001
70984483|NCT01380093|141477989|SUPERIORITY_OR_OTHER||LS Mean Difference|404.9|||<|0.0001|TWO_SIDED|95.0|356.4|453.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||453.3|356.4|<0.0001
70984484|NCT01380093|141477990|SUPERIORITY_OR_OTHER||LS Mean Difference|-306.8|||<|0.0001|TWO_SIDED|95.0|-370.9|-242.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-242.6|-370.9|<0.0001
70984485|NCT01380093|141477990|SUPERIORITY_OR_OTHER||LS Mean Difference|168.6|||<|0.0001|TWO_SIDED|95.0|104.7|232.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||232.6|104.7|<0.0001
70984486|NCT01380093|141477990|SUPERIORITY_OR_OTHER||LS Mean Difference|475.4|||<|0.0001|TWO_SIDED|95.0|411.3|539.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||539.6|411.3|<0.0001
70984487|NCT01380093|141477991|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.5607|TWO_SIDED|95.0|-0.6|1.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.0|-0.6|0.5607
70984488|NCT01380093|141477991|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0|||<|0.0001|TWO_SIDED|95.0|1.2|2.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.8|1.2|<0.0001
71037477|NCT02997176|141582036|OTHER|Bioequivalence|Percent Ratio of Geometric Means|99.31|||||TWO_SIDED|90.0|57.74|170.8||||||Cmax was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||170.80|57.74|
71037478|NCT02997176|141582036|OTHER|Bioequivalence|Percent Ratio of Geometric Means|96.45|||||TWO_SIDED|90.0|52.22|178.14||||||Cmax was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||178.14|52.22|
71097667|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|0.3|||||TWO_SIDED|95.0|0.07|1.24||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.24|0.07|
71097668|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|0.3|||||TWO_SIDED|95.0|0.06|2.08||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.08|0.06|
70984489|NCT01380093|141477991|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8|||<|0.0001|TWO_SIDED|95.0|1.0|2.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.6|1.0|<0.0001
70984490|NCT01380093|141477992|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.3|||<|0.0001|TWO_SIDED|95.0|-20.3|-10.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-10.3|-20.3|<0.0001
70984491|NCT01380093|141477992|SUPERIORITY_OR_OTHER||LS Mean Difference|11.2|||<|0.0001|TWO_SIDED|95.0|6.3|16.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||16.2|6.3|<0.0001
70984492|NCT01380093|141477992|SUPERIORITY_OR_OTHER||LS Mean Difference|26.5|||<|0.0001|TWO_SIDED|95.0|21.5|31.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||31.5|21.5|<0.0001
70984493|NCT01380093|141477993|SUPERIORITY_OR_OTHER||LS Mean Difference|-47.7|||<|0.0001|TWO_SIDED|95.0|-59.5|-35.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-35.9|-59.5|<0.0001
71037479|NCT02997176|141582036|OTHER|Bioequivalence|Percent Ratio of Geometric Means|64.05|||||TWO_SIDED|90.0|39.65|103.46||||||Cmax was natural log-transformed and analyzed using ANOVA model with hepatic function group as a fixed effect.||103.46|39.65|
71037480|NCT02997176|141582039|OTHER|Bioequivalence|Percent Ratio of Geometric Means|118.47|||||TWO_SIDED|90.0|83.81|167.47||||||AUC0-24u was natural log-transformed and analyzed using ANOVA model with hepatic function group as a fixed effect.||167.47|83.81|
71037481|NCT02997176|141582039|OTHER|Bioequivalence|Percent Ratio of Geometric Means|108.36|||||TWO_SIDED|90.0|73.25|160.3||||||AUC0-24u was natural log-transformed and analyzed using ANOVA model with hepatic function group as a fixed effect.||160.30|73.25|
71097669|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|1.3|||||TWO_SIDED|95.0|0.79|1.97||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.97|0.79|
70984494|NCT01380093|141477993|SUPERIORITY_OR_OTHER||LS Mean Difference|28.3|||<|0.0001|TWO_SIDED|95.0|16.5|40.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||40.1|16.5|<0.0001
70984495|NCT01380093|141477993|SUPERIORITY_OR_OTHER||LS Mean Difference|76.0|||<|0.0001|TWO_SIDED|95.0|64.2|87.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||87.8|64.2|<0.0001
70984496|NCT01380093|141477994|SUPERIORITY_OR_OTHER||LS Mean Difference|-109.3|||<|0.0001|TWO_SIDED|95.0|-132.9|-85.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-85.6|-132.9|<0.0001
70984497|NCT01380093|141477994|SUPERIORITY_OR_OTHER||LS Mean Difference|67.0|||<|0.0001|TWO_SIDED|95.0|43.5|90.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||90.6|43.5|<0.0001
70984498|NCT01380093|141477994|SUPERIORITY_OR_OTHER||LS Mean Difference|176.3|||<|0.0001|TWO_SIDED|95.0|152.6|199.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||199.9|152.6|<0.0001
70984499|NCT01380093|141477995|SUPERIORITY_OR_OTHER||LS Mean Difference|-190.8|||<|0.0001|TWO_SIDED|95.0|-234.2|-147.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-147.3|-234.2|<0.0001
70984500|NCT01380093|141477995|SUPERIORITY_OR_OTHER||LS Mean Difference|134.7|||<|0.0001|TWO_SIDED|95.0|91.5|178.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||178.0|91.5|<0.0001
70984501|NCT01380093|141477995|SUPERIORITY_OR_OTHER||LS Mean Difference|325.5|||<|0.0001|TWO_SIDED|95.0|282.1|368.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||368.9|282.1|<0.0001
70984502|NCT01380093|141477996|SUPERIORITY_OR_OTHER||LS Mean Difference|-244.9|||<|0.0001|TWO_SIDED|95.0|-302.0|-187.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-187.7|-302.0|<0.0001
70984503|NCT01380093|141477996|SUPERIORITY_OR_OTHER||LS Mean Difference|166.5|||<|0.0001|TWO_SIDED|95.0|109.5|223.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||223.5|109.5|<0.0001
71037482|NCT02997176|141582039|OTHER|Bioequivalence|Percent Ratio of Geometric Means|117.84|||||TWO_SIDED|90.0|85.29|162.83||||||AUC0-24u was natural log-transformed and analyzed using ANOVA model with hepatic function group as a fixed effect.||162.83|85.29|
71037483|NCT02997176|141582040|OTHER|Bioequivalence|Percent Ratio of Geometric Means|94.58|||||TWO_SIDED|90.0|56.74|157.64||||||Cmaxu was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||157.64|56.74|
71037484|NCT02997176|141582040|OTHER|Bioequivalence|Percent Ratio of Geometric Means|92.15|||||TWO_SIDED|90.0|51.69|164.26||||||Cmaxu was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||164.26|51.69|
71037485|NCT02997176|141582040|OTHER|Bioequivalence|Percent Ratio of Geometric Means|84.42|||||TWO_SIDED|90.0|53.14|134.1||||||Cmaxu was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||134.10|53.14|
71037486|NCT00373256|141582090|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6299||||0.9986|TWO_SIDED|95.0|1.1793|2.2527||p-value from 1-sided log-rank stratified for prior adjuvant chemotherapy, hormone receptor status, disease-free interval from prior adjuvant treatment. Stratification factors from Interactive Voice Randomization System.|Log Rank||Assuming proportional hazards, a hazard ratio greater than 1 indicated a reduction in hazard rate in favor Bevacizumab + Paclitaxel.|||2.2527|1.1793|0.9986
70984504|NCT01380093|141477996|SUPERIORITY_OR_OTHER||LS Mean Difference|411.4|||<|0.0001|TWO_SIDED|95.0|354.3|468.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||468.6|354.3|<0.0001
70984505|NCT01380093|141477997|SUPERIORITY_OR_OTHER||LS Mean Difference|-310.0|||<|0.0001|TWO_SIDED|95.0|-384.5|-235.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-235.5|-384.5|<0.0001
70984506|NCT01380093|141477997|SUPERIORITY_OR_OTHER||LS Mean Difference|185.2|||<|0.0001|TWO_SIDED|95.0|110.8|259.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||259.5|110.8|<0.0001
70984507|NCT01380093|141477997|SUPERIORITY_OR_OTHER||LS Mean Difference|495.1|||<|0.0001|TWO_SIDED|95.0|420.6|569.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||569.7|420.6|<0.0001
70984508|NCT01380093|141477998|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.5|||<|0.0001|TWO_SIDED|95.0|-38.7|-22.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-22.3|-38.7|<0.0001
71037487|NCT00373256|141582091|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|32.2|||||TWO_SIDED|95.0|26.4|38.5||||||||38.5|26.4|
71097670|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|0.6|||||TWO_SIDED|95.0|0.38|0.88||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.88|0.38|
71097671|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|0.5|||||TWO_SIDED|95.0|0.27|0.77||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.77|0.27|
71097672|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|2.0|||||TWO_SIDED|95.0|0.85|4.9||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.90|0.85|
70984509|NCT01380093|141477998|SUPERIORITY_OR_OTHER||LS Mean Difference|30.8|||<|0.0001|TWO_SIDED|95.0|22.6|39.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||39.0|22.6|<0.0001
70984510|NCT01380093|141477998|SUPERIORITY_OR_OTHER||LS Mean Difference|61.3|||<|0.0001|TWO_SIDED|95.0|53.1|69.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||69.5|53.1|<0.0001
70984511|NCT01380093|141477999|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.8671|TWO_SIDED|95.0|-1.0|0.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.8|-1.0|0.8671
70984512|NCT01380093|141477999|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8||||0.0001|TWO_SIDED|95.0|0.9|2.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.7|0.9|0.0001
70984513|NCT01380093|141477999|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9|||<|0.0001|TWO_SIDED|95.0|1.0|2.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.8|1.0|<0.0001
70984514|NCT01380093|141478000|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.0|||<|0.0001|TWO_SIDED|95.0|-17.0|-9.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-9.0|-17.0|<0.0001
70984515|NCT01380093|141478000|SUPERIORITY_OR_OTHER||LS Mean Difference|8.8|||<|0.0001|TWO_SIDED|95.0|4.8|12.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||12.8|4.8|<0.0001
70984516|NCT01380093|141478000|SUPERIORITY_OR_OTHER||LS Mean Difference|21.8|||<|0.0001|TWO_SIDED|95.0|17.8|25.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||25.8|17.8|<0.0001
70984517|NCT01380093|141478001|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.3|||<|0.0001|TWO_SIDED|95.0|-55.3|-35.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-35.3|-55.3|<0.0001
70984518|NCT01380093|141478001|SUPERIORITY_OR_OTHER||LS Mean Difference|24.5|||<|0.0001|TWO_SIDED|95.0|14.6|34.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||34.5|14.6|<0.0001
71037488|NCT00373256|141582091|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|32.1|||||TWO_SIDED|95.0|26.3|38.4||||||||38.4|26.3|
71037489|NCT00373256|141582094|SUPERIORITY_OR_OTHER||Percentage|76.8|||||TWO_SIDED|95.0|68.7|83.0||||||1 year||83.0|68.7|
71037490|NCT00373256|141582094|SUPERIORITY_OR_OTHER||Percentage|35.5|||||TWO_SIDED|95.0|20.9|50.3||||||2 years||50.3|20.9|
71037491|NCT00373256|141582094|SUPERIORITY_OR_OTHER||Percentage|83.7|||||TWO_SIDED|95.0|76.0|89.1||||||1 year||89.1|76.0|
70984519|NCT01380093|141478001|SUPERIORITY_OR_OTHER||LS Mean Difference|69.8|||<|0.0001|TWO_SIDED|95.0|59.9|79.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||79.8|59.9|<0.0001
70984520|NCT01380093|141478002|SUPERIORITY_OR_OTHER||LS Mean Difference|-109.1|||<|0.0001|TWO_SIDED|95.0|-129.3|-88.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-88.8|-129.3|<0.0001
70984521|NCT01380093|141478002|SUPERIORITY_OR_OTHER||LS Mean Difference|60.1|||<|0.0001|TWO_SIDED|95.0|39.9|80.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||80.4|39.9|<0.0001
70984522|NCT01380093|141478002|SUPERIORITY_OR_OTHER||LS Mean Difference|169.2|||<|0.0001|TWO_SIDED|95.0|148.9|189.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||189.5|148.9|<0.0001
70984523|NCT01380093|141478003|SUPERIORITY_OR_OTHER||LS Mean Difference|-207.0|||<|0.0001|TWO_SIDED|95.0|-242.0|-172.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-172.1|-242.0|<0.0001
71037492|NCT00373256|141582094|SUPERIORITY_OR_OTHER||Percentage|61.0|||||TWO_SIDED|95.0|43.2|74.7||||||2 years||74.7|43.2|
71037493|NCT02645253|141582119|SUPERIORITY_OR_OTHER||Slope|1.02|STANDARD_ERROR_OF_MEAN|0.0785|||TWO_SIDED|90.0|0.882|1.15|||Linear Model|||||1.15|0.882|
71037494|NCT02645253|141582121|SUPERIORITY_OR_OTHER||Slope|1.14|STANDARD_ERROR_OF_MEAN|0.0503|||TWO_SIDED|90.0|1.06|1.23|||Linear Model|||||1.23|1.06|
71097673|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|1.1|||||TWO_SIDED|95.0|0.49|2.48||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.48|0.49|
70984524|NCT01380093|141478003|SUPERIORITY_OR_OTHER||LS Mean Difference|118.7|||<|0.0001|TWO_SIDED|95.0|83.9|153.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||153.5|83.9|<0.0001
70984525|NCT01380093|141478003|SUPERIORITY_OR_OTHER||LS Mean Difference|325.8|||<|0.0001|TWO_SIDED|95.0|290.8|360.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||360.7|290.8|<0.0001
70984526|NCT01380093|141478004|SUPERIORITY_OR_OTHER||LS Mean Difference|-268.2|||<|0.0001|TWO_SIDED|95.0|-313.2|-223.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-223.2|-313.2|<0.0001
70984527|NCT01380093|141478004|SUPERIORITY_OR_OTHER||LS Mean Difference|147.0|||<|0.0001|TWO_SIDED|95.0|102.1|191.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||191.9|102.1|<0.0001
70984528|NCT01380093|141478004|SUPERIORITY_OR_OTHER||LS Mean Difference|415.2|||<|0.0001|TWO_SIDED|95.0|370.2|460.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||460.2|370.2|<0.0001
70984529|NCT01380093|141478005|SUPERIORITY_OR_OTHER||LS Mean Difference|-336.0|||<|0.0001|TWO_SIDED|95.0|-395.4|-276.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-276.6|-395.4|<0.0001
70984530|NCT01380093|141478005|SUPERIORITY_OR_OTHER||LS Mean Difference|165.6|||<|0.0001|TWO_SIDED|95.0|106.4|224.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||224.8|106.4|<0.0001
70984531|NCT01380093|141478005|SUPERIORITY_OR_OTHER||LS Mean Difference|501.6|||<|0.0001|TWO_SIDED|95.0|442.2|561.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||561.0|442.2|<0.0001
70984532|NCT01380093|141478006|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.8|||<|0.0001|TWO_SIDED|95.0|-40.7|-26.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-26.8|-40.7|<0.0001
71037495|NCT02645253|141582123|SUPERIORITY_OR_OTHER||Slope|1.05|STANDARD_ERROR_OF_MEAN|0.119|||TWO_SIDED|90.0|0.801|1.31|||Linear Model|||||1.31|0.801|
71037496|NCT02645253|141582133|SUPERIORITY_OR_OTHER||Slope|0.979|STANDARD_ERROR_OF_MEAN|0.0633|||TWO_SIDED|90.0|0.87|1.09|||Linear Model|||||1.09|0.870|
71037497|NCT02645253|141582138|SUPERIORITY_OR_OTHER||Slope|1.05|STANDARD_ERROR_OF_MEAN|0.0552|||TWO_SIDED|90.0|0.951|1.14|||Linear Model|||||1.14|0.951|
71037498|NCT02645253|141582150|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean (%)|102.99|||||TWO_SIDED|95.0|86.88|122.09|||ANCOVA||Day 1/ Day -1|||122.09|86.88|
71037499|NCT02645253|141582150|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean (%)|91.82|||||TWO_SIDED|95.0|77.32|109.04|||ANCOVA||Day 16 / Day -1|||109.04|77.32|
71037500|NCT02645253|141582150|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean (%)|105.92|||||TWO_SIDED|95.0|89.4|125.49|||ANCOVA||Day 1 / Day -1|||125.49|89.40|
71037501|NCT02645253|141582150|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean (%)|89.44|||||TWO_SIDED|95.0|75.35|106.16|||ANCOVA||Day 16 / Day -1|||106.16|75.35|
71037502|NCT02645253|141582150|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean (%)|99.82|||||TWO_SIDED|95.0|84.12|118.46|||ANCOVA||Day 1 / Day -1|||118.46|84.12|
71097674|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|0.5|||||TWO_SIDED|95.0|0.2|1.45||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.45|0.20|
70984533|NCT01380093|141478006|SUPERIORITY_OR_OTHER||LS Mean Difference|26.7|||<|0.0001|TWO_SIDED|95.0|19.7|33.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||33.6|19.7|<0.0001
70984534|NCT01380093|141478006|SUPERIORITY_OR_OTHER||LS Mean Difference|60.4|||<|0.0001|TWO_SIDED|95.0|53.4|67.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||67.4|53.4|<0.0001
70984535|NCT01380093|141478007|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.3345|TWO_SIDED|95.0|-0.4|1.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.3|-0.4|0.3345
70984536|NCT01380093|141478007|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4|||<|0.0001|TWO_SIDED|95.0|1.5|3.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||3.3|1.5|<0.0001
70984537|NCT01380093|141478007|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0|||<|0.0001|TWO_SIDED|95.0|1.1|2.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.8|1.1|<0.0001
70984538|NCT01380093|141478008|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0||||0.0453|TWO_SIDED|95.0|-2.0|0.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-0.0|-2.0|0.0453
70984539|NCT01380093|141478008|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.5637|TWO_SIDED|95.0|-0.7|1.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.3|-0.7|0.5637
70984540|NCT01380093|141478008|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3||||0.011|TWO_SIDED|95.0|0.3|2.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.3|0.3|0.0110
70984541|NCT01380093|141478009|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.9||||0.0041|TWO_SIDED|95.0|-8.2|-1.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-1.6|-8.2|0.0041
70984542|NCT01380093|141478009|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1||||0.2178|TWO_SIDED|95.0|-1.2|5.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||5.3|-1.2|0.2178
70984543|NCT01380093|141478009|SUPERIORITY_OR_OTHER||LS Mean Difference|7.0|||<|0.0001|TWO_SIDED|95.0|3.7|10.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||10.3|3.7|<0.0001
70984544|NCT01380093|141478010|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.4||||0.0001|TWO_SIDED|95.0|-28.8|-9.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-9.9|-28.8|0.0001
70984545|NCT01380093|141478010|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9||||0.151|TWO_SIDED|95.0|-2.6|16.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||16.3|-2.6|0.1510
70984546|NCT01380093|141478010|SUPERIORITY_OR_OTHER||LS Mean Difference|26.2|||<|0.0001|TWO_SIDED|95.0|16.8|35.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||35.7|16.8|<0.0001
70984547|NCT01380093|141478011|SUPERIORITY_OR_OTHER||LS Mean Difference|-55.2|||<|0.0001|TWO_SIDED|95.0|-75.9|-34.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-34.4|-75.9|<0.0001
70984548|NCT01380093|141478011|SUPERIORITY_OR_OTHER||LS Mean Difference|18.5||||0.0796|TWO_SIDED|95.0|-2.2|39.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||39.2|-2.2|0.0796
70984549|NCT01380093|141478011|SUPERIORITY_OR_OTHER||LS Mean Difference|73.6|||<|0.0001|TWO_SIDED|95.0|52.9|94.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||94.4|52.9|<0.0001
70984550|NCT01380093|141478012|SUPERIORITY_OR_OTHER||LS Mean Difference|-82.8|||<|0.0001|TWO_SIDED|95.0|-112.9|-52.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-52.7|-112.9|<0.0001
70984551|NCT01380093|141478012|SUPERIORITY_OR_OTHER||LS Mean Difference|26.9||||0.078|TWO_SIDED|95.0|-3.1|56.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||56.9|-3.1|0.0780
70984552|NCT01380093|141478012|SUPERIORITY_OR_OTHER||LS Mean Difference|109.7|||<|0.0001|TWO_SIDED|95.0|79.6|139.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||139.8|79.6|<0.0001
70984553|NCT01380093|141478013|SUPERIORITY_OR_OTHER||LS Mean Difference|-111.9|||<|0.0001|TWO_SIDED|95.0|-153.7|-70.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-70.2|-153.7|<0.0001
70984554|NCT01380093|141478013|SUPERIORITY_OR_OTHER||LS Mean Difference|33.9||||0.1089|TWO_SIDED|95.0|-7.8|75.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||75.5|-7.8|0.1089
70984555|NCT01380093|141478013|SUPERIORITY_OR_OTHER||LS Mean Difference|145.8|||<|0.0001|TWO_SIDED|95.0|104.1|187.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||187.5|104.1|<0.0001
70984556|NCT01380093|141478014|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.7|||<|0.0001|TWO_SIDED|95.0|-18.8|-8.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-8.6|-18.8|<0.0001
70984557|NCT01380093|141478014|SUPERIORITY_OR_OTHER||LS Mean Difference|6.0||||0.0215|TWO_SIDED|95.0|0.9|11.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||11.1|0.9|0.0215
70984558|NCT01380093|141478014|SUPERIORITY_OR_OTHER||LS Mean Difference|19.7|||<|0.0001|TWO_SIDED|95.0|14.6|24.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||24.8|14.6|<0.0001
70984559|NCT01380093|141478015|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3||||0.0007|TWO_SIDED|95.0|-3.6|-1.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-1.0|-3.6|0.0007
70984560|NCT01380093|141478015|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3||||0.0455|TWO_SIDED|95.0|0.0|2.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.6|0.0|0.0455
70984561|NCT01380093|141478015|SUPERIORITY_OR_OTHER||LS Mean Difference|3.6|||<|0.0001|TWO_SIDED|95.0|2.3|4.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.9|2.3|<0.0001
70984562|NCT01380093|141478016|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.3749|TWO_SIDED|95.0|-0.9|0.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.3|-0.9|0.3749
70984563|NCT01380093|141478016|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.7939|TWO_SIDED|95.0|-0.5|0.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.7|-0.5|0.7939
70984564|NCT01380093|141478016|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.2524|TWO_SIDED|95.0|-0.3|1.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.0|-0.3|0.2524
70984565|NCT01380093|141478017|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7||||0.1211|TWO_SIDED|95.0|-3.8|0.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.5|-3.8|0.1211
70984566|NCT01380093|141478017|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4||||0.1997|TWO_SIDED|95.0|-0.7|3.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||3.5|-0.7|0.1997
70984567|NCT01380093|141478017|SUPERIORITY_OR_OTHER||LS Mean Difference|3.1||||0.0057|TWO_SIDED|95.0|0.9|5.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||5.2|0.9|0.0057
70984568|NCT01380093|141478018|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.8||||0.0057|TWO_SIDED|95.0|-16.7|-3.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-3.0|-16.7|0.0057
70984569|NCT01380093|141478018|SUPERIORITY_OR_OTHER||LS Mean Difference|4.5||||0.1918|TWO_SIDED|95.0|-2.3|11.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||11.4|-2.3|0.1918
70984570|NCT01380093|141478018|SUPERIORITY_OR_OTHER||LS Mean Difference|14.4|||<|0.0001|TWO_SIDED|95.0|7.5|21.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||21.2|7.5|<0.0001
70984571|NCT01380093|141478019|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.5||||0.0013|TWO_SIDED|95.0|-50.2|-12.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-12.9|-50.2|0.0013
70984572|NCT01380093|141478019|SUPERIORITY_OR_OTHER||LS Mean Difference|14.9||||0.1136|TWO_SIDED|95.0|-3.7|33.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||33.5|-3.7|0.1136
70984573|NCT01380093|141478019|SUPERIORITY_OR_OTHER||LS Mean Difference|46.5|||<|0.0001|TWO_SIDED|95.0|27.8|65.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||65.1|27.8|<0.0001
70984574|NCT01380093|141478020|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.6||||0.0006|TWO_SIDED|95.0|-83.2|-24.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-24.0|-83.2|0.0006
70984575|NCT01380093|141478020|SUPERIORITY_OR_OTHER||LS Mean Difference|23.2||||0.1207|TWO_SIDED|95.0|-6.3|52.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||52.7|-6.3|0.1207
70984576|NCT01380093|141478020|SUPERIORITY_OR_OTHER||LS Mean Difference|76.8|||<|0.0001|TWO_SIDED|95.0|47.3|106.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||106.4|47.3|<0.0001
70984577|NCT01380093|141478021|SUPERIORITY_OR_OTHER||LS Mean Difference|-75.8||||0.0008|TWO_SIDED|95.0|-118.6|-33.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-33.0|-118.6|0.0008
70984578|NCT01380093|141478021|SUPERIORITY_OR_OTHER||LS Mean Difference|31.8||||0.141|TWO_SIDED|95.0|-10.8|74.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||74.5|-10.8|0.1410
70984579|NCT01380093|141478021|SUPERIORITY_OR_OTHER||LS Mean Difference|107.7|||<|0.0001|TWO_SIDED|95.0|64.9|150.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||150.5|64.9|<0.0001
70984580|NCT01380093|141478022|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.0|||<|0.0001|TWO_SIDED|95.0|-14.4|-5.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-5.6|-14.4|<0.0001
70984581|NCT01380093|141478022|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3||||0.0529|TWO_SIDED|95.0|-0.1|8.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||8.7|-0.1|0.0529
70984582|NCT01380093|141478022|SUPERIORITY_OR_OTHER||LS Mean Difference|14.3|||<|0.0001|TWO_SIDED|95.0|9.9|18.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||18.7|9.9|<0.0001
70984583|NCT01380093|141478023|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8||||0.0806|TWO_SIDED|95.0|-3.8|0.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.2|-3.8|0.0806
70984584|NCT01380093|141478023|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1||||0.2769|TWO_SIDED|95.0|-0.9|3.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||3.1|-0.9|0.2769
70984585|NCT01380093|141478023|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9||||0.0056|TWO_SIDED|95.0|0.9|5.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||5.0|0.9|0.0056
70984586|NCT01380093|141478024|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8||||0.11|TWO_SIDED|95.0|-1.7|0.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.2|-1.7|0.1100
70984587|NCT01380093|141478024|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.9421|TWO_SIDED|95.0|-1.0|0.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.9|-1.0|0.9421
70984588|NCT01380093|141478024|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.1266|TWO_SIDED|95.0|-0.2|1.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.7|-0.2|0.1266
70984589|NCT01380093|141478025|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.6||||0.0723|TWO_SIDED|95.0|-5.3|0.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.2|-5.3|0.0723
70984590|NCT01380093|141478025|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1||||0.4515|TWO_SIDED|95.0|-1.7|3.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||3.8|-1.7|0.4515
70984591|NCT01380093|141478025|SUPERIORITY_OR_OTHER||LS Mean Difference|3.6||||0.0121|TWO_SIDED|95.0|0.8|6.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||6.4|0.8|0.0121
70984592|NCT01380093|141478026|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.0||||0.0059|TWO_SIDED|95.0|-18.7|-3.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-3.3|-18.7|0.0059
70984593|NCT01380093|141478026|SUPERIORITY_OR_OTHER||LS Mean Difference|4.2||||0.28|TWO_SIDED|95.0|-3.5|11.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||11.8|-3.5|0.2800
71037503|NCT02645253|141582150|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean (%)|75.38||||||95.0|63.4|89.61|||ANCOVA||Day 16 / Day -1|||89.61|63.40|
71037504|NCT02752074|141582156|OTHER||Hazard Ratio (HR)|1.0||||0.51711|TWO_SIDED|95.0|0.83|1.21||One-sided p-value based on log-rank test.|Log Rank|||||1.21|0.83|0.51711
71037505|NCT02752074|141582157|OTHER||Hazard Ratio (HR)|1.13||||0.80666|TWO_SIDED|95.0|0.86|1.49||One-sided p-value based on log-rank test.|Log Rank|||||1.49|0.86|0.80666
71037506|NCT02554877|141582180|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.91|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.34|-0.48||Two (2)-sided p-values were from mixed model for repeated measurements (MMRM) with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12||-0.48|-1.34|<0.0001
70984594|NCT01380093|141478026|SUPERIORITY_OR_OTHER||LS Mean Difference|15.1||||0.0002|TWO_SIDED|95.0|7.5|22.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||22.8|7.5|0.0002
70984595|NCT01380093|141478027|SUPERIORITY_OR_OTHER||LS Mean Difference|-36.7||||0.0001|TWO_SIDED|95.0|-54.8|-18.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-18.6|-54.8|0.0001
70984596|NCT01380093|141478027|SUPERIORITY_OR_OTHER||LS Mean Difference|13.2||||0.1488|TWO_SIDED|95.0|-4.8|31.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||31.2|-4.8|0.1488
70984597|NCT01380093|141478027|SUPERIORITY_OR_OTHER||LS Mean Difference|49.9|||<|0.0001|TWO_SIDED|95.0|31.8|67.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||67.9|31.8|<0.0001
70984598|NCT01380093|141478028|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.1|||<|0.0001|TWO_SIDED|95.0|-88.5|-31.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-31.6|-88.5|<0.0001
70984599|NCT01380093|141478028|SUPERIORITY_OR_OTHER||LS Mean Difference|20.4||||0.1556|TWO_SIDED|95.0|-8.0|48.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||48.7|-8.0|0.1556
70984600|NCT01380093|141478028|SUPERIORITY_OR_OTHER||LS Mean Difference|80.4|||<|0.0001|TWO_SIDED|95.0|52.0|108.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||108.9|52.0|<0.0001
70984601|NCT01380093|141478029|SUPERIORITY_OR_OTHER||LS Mean Difference|-84.0||||0.0001|TWO_SIDED|95.0|-124.8|-43.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-43.2|-124.8|0.0001
70984602|NCT01380093|141478029|SUPERIORITY_OR_OTHER||LS Mean Difference|27.4||||0.1826|TWO_SIDED|95.0|-13.3|68.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||68.1|-13.3|0.1826
70984603|NCT01380093|141478029|SUPERIORITY_OR_OTHER||LS Mean Difference|111.4|||<|0.0001|TWO_SIDED|95.0|70.6|152.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||152.2|70.6|<0.0001
70984604|NCT01380093|141478030|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.7|||<|0.0001|TWO_SIDED|95.0|-16.4|-7.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-7.0|-16.4|<0.0001
70984605|NCT01380093|141478030|SUPERIORITY_OR_OTHER||LS Mean Difference|4.2||||0.0811|TWO_SIDED|95.0|-0.5|8.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||8.9|-0.5|0.0811
71037507|NCT02554877|141582180|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.16|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.59|-0.73||Two (2)-sided p-values were from mixed model for repeated measurements (MMRM) with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12||-0.73|-1.59|<0.0001
71037508|NCT02554877|141582180|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.17|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.6|-0.74||Two (2)-sided p-values were from mixed model for repeated measurements (MMRM) with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||-0.74|-1.60|<0.0001
70984606|NCT01380093|141478030|SUPERIORITY_OR_OTHER||LS Mean Difference|15.9|||<|0.0001|TWO_SIDED|95.0|11.1|20.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||20.6|11.1|<0.0001
70984607|NCT01380093|141478031|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5||||0.0007|TWO_SIDED|95.0|-3.8|-1.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-1.1|-3.8|0.0007
70984608|NCT01380093|141478031|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0||||0.1631|TWO_SIDED|95.0|-0.4|2.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.3|-0.4|0.1631
70984609|NCT01380093|141478031|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4|||<|0.0001|TWO_SIDED|95.0|2.1|4.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.8|2.1|<0.0001
71097675|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.87|1.15||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.15|0.87|
71097676|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.79|1.03||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.03|0.79|
71097677|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.76|1.06||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.06|0.76|
71097678|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|16.5|||||TWO_SIDED|95.0|3.56|76.14||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||76.14|3.56|
71097679|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|2.3|||||TWO_SIDED|95.0|0.56|9.06||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||9.06|0.56|
71097680|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|0.1|||||TWO_SIDED|95.0|0.02|0.78||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.78|0.02|
71097681|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|1.3|||||TWO_SIDED|95.0|0.22|7.07||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||7.07|0.22|
70984610|NCT01380093|141478032|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.2||||0.2117|TWO_SIDED|95.0|-3.1|0.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.7|-3.1|0.2117
70984611|NCT01380093|141478032|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1||||0.0345|TWO_SIDED|95.0|0.2|4.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.0|0.2|0.0345
70984612|NCT01380093|141478032|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3||||0.0011|TWO_SIDED|95.0|1.4|5.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||5.2|1.4|0.0011
70984613|NCT01380093|141478033|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.2||||0.0002|TWO_SIDED|95.0|-18.4|-6.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-6.0|-18.4|0.0002
70984614|NCT01380093|141478033|SUPERIORITY_OR_OTHER||LS Mean Difference|8.4||||0.0081|TWO_SIDED|95.0|2.3|14.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||14.6|2.3|0.0081
70984615|NCT01380093|141478033|SUPERIORITY_OR_OTHER||LS Mean Difference|20.6|||<|0.0001|TWO_SIDED|95.0|14.4|26.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||26.8|14.4|<0.0001
70984616|NCT01380093|141478034|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.2|||<|0.0001|TWO_SIDED|95.0|-55.6|-20.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-20.8|-55.6|<0.0001
70984617|NCT01380093|141478034|SUPERIORITY_OR_OTHER||LS Mean Difference|34.4||||0.0002|TWO_SIDED|95.0|17.0|51.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||51.7|17.0|0.0002
70984618|NCT01380093|141478034|SUPERIORITY_OR_OTHER||LS Mean Difference|72.6|||<|0.0001|TWO_SIDED|95.0|55.2|90.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||90.0|55.2|<0.0001
70984619|NCT01380093|141478035|SUPERIORITY_OR_OTHER||LS Mean Difference|-100.3|||<|0.0001|TWO_SIDED|95.0|-142.2|-58.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-58.4|-142.2|<0.0001
70984620|NCT01380093|141478035|SUPERIORITY_OR_OTHER||LS Mean Difference|93.9|||<|0.0001|TWO_SIDED|95.0|52.1|135.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||135.7|52.1|<0.0001
71097682|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|0.2|||||TWO_SIDED|95.0|0.03|0.74||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.74|0.03|
71097683|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|0.1|||||TWO_SIDED|95.0|0.02|0.84||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.84|0.02|
71097684|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|4.8|||||TWO_SIDED|95.0|1.35|16.98||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||16.98|1.35|
71097685|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.28|3.23||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.23|0.28|
71097686|NCT01026038|141703961|SUPERIORITY_OR_OTHER||GMT ratio|0.2|||||TWO_SIDED|95.0|0.05|0.85||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.85|0.05|
71097687|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.8|1.38||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.38|0.80|
71097688|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.76|1.3||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.30|0.76|
71097689|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.69|1.3||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.30|0.69|
71097690|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|0.7|||||TWO_SIDED|95.0|0.49|0.9||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.90|0.49|
70984621|NCT01380093|141478035|SUPERIORITY_OR_OTHER||LS Mean Difference|194.2|||<|0.0001|TWO_SIDED|95.0|152.3|236.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||236.1|152.3|<0.0001
70984622|NCT01380093|141478036|SUPERIORITY_OR_OTHER||LS Mean Difference|-147.4|||<|0.0001|TWO_SIDED|95.0|-205.1|-89.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-89.6|-205.1|<0.0001
71097691|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|0.7|||||TWO_SIDED|95.0|0.55|1.01||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.01|0.55|
70984623|NCT01380093|141478036|SUPERIORITY_OR_OTHER||LS Mean Difference|134.1|||<|0.0001|TWO_SIDED|95.0|76.5|191.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||191.7|76.5|<0.0001
70984624|NCT01380093|141478036|SUPERIORITY_OR_OTHER||LS Mean Difference|281.5|||<|0.0001|TWO_SIDED|95.0|223.7|339.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||339.2|223.7|<0.0001
70984625|NCT01380093|141478037|SUPERIORITY_OR_OTHER||LS Mean Difference|-201.4|||<|0.0001|TWO_SIDED|95.0|-279.3|-123.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-123.6|-279.3|<0.0001
70984626|NCT01380093|141478037|SUPERIORITY_OR_OTHER||LS Mean Difference|169.1|||<|0.0001|TWO_SIDED|95.0|91.5|246.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||246.7|91.5|<0.0001
70984627|NCT01380093|141478037|SUPERIORITY_OR_OTHER||LS Mean Difference|370.5|||<|0.0001|TWO_SIDED|95.0|292.7|448.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||448.4|292.7|<0.0001
70984628|NCT01380093|141478038|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.4|||<|0.0001|TWO_SIDED|95.0|-23.8|-9.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-9.0|-23.8|<0.0001
70984629|NCT01380093|141478038|SUPERIORITY_OR_OTHER||LS Mean Difference|25.7|||<|0.0001|TWO_SIDED|95.0|18.3|33.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||33.1|18.3|<0.0001
70984630|NCT01380093|141478038|SUPERIORITY_OR_OTHER||LS Mean Difference|42.1|||<|0.0001|TWO_SIDED|95.0|34.7|49.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||49.5|34.7|<0.0001
70984631|NCT01380093|141478039|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4||||0.0253|TWO_SIDED|95.0|-2.6|-0.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-0.2|-2.6|0.0253
70984632|NCT01380093|141478039|SUPERIORITY_OR_OTHER||LS Mean Difference|2.8|||<|0.0001|TWO_SIDED|95.0|1.6|4.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.0|1.6|<0.0001
70984633|NCT01380093|141478039|SUPERIORITY_OR_OTHER||LS Mean Difference|4.2|||<|0.0001|TWO_SIDED|95.0|3.0|5.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||5.4|3.0|<0.0001
70984634|NCT01380093|141478040|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1||||0.0062|TWO_SIDED|95.0|-3.7|-0.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-0.6|-3.7|0.0062
70984635|NCT01380093|141478040|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.4998|TWO_SIDED|95.0|-1.0|2.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.0|-1.0|0.4998
70984636|NCT01380093|141478040|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7||||0.0008|TWO_SIDED|95.0|1.1|4.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.2|1.1|0.0008
70984637|NCT01380093|141478041|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.0||||0.0009|TWO_SIDED|95.0|-11.1|-3.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-3.0|-11.1|0.0009
70984638|NCT01380093|141478041|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2||||0.2693|TWO_SIDED|95.0|-1.8|6.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||6.3|-1.8|0.2693
70984639|NCT01380093|141478041|SUPERIORITY_OR_OTHER||LS Mean Difference|9.3|||<|0.0001|TWO_SIDED|95.0|5.3|13.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||13.3|5.3|<0.0001
70984640|NCT01380093|141478042|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.2||||0.0042|TWO_SIDED|95.0|-27.2|-5.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-5.3|-27.2|0.0042
71097692|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|1.1|||||TWO_SIDED|95.0|0.79|1.59||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.59|0.79|
71037509|NCT02554877|141582181|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.39|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.52|-0.26||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects|ANCOVA|Least squares mean (LS mean) difference from placebo adjusted for baseline values was derived from the ANCOVA model||Placebo was the reference and each of the active doses was the test for Week 2.||-0.26|-0.52|<0.0001
70984641|NCT01380093|141478042|SUPERIORITY_OR_OTHER||LS Mean Difference|8.7||||0.1139|TWO_SIDED|95.0|-2.2|19.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||19.6|-2.2|0.1139
70984642|NCT01380093|141478042|SUPERIORITY_OR_OTHER||LS Mean Difference|25.0|||<|0.0001|TWO_SIDED|95.0|14.1|35.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||35.9|14.1|<0.0001
70984643|NCT01380093|141478043|SUPERIORITY_OR_OTHER||LS Mean Difference|-34.9|||<|0.0001|TWO_SIDED|95.0|-42.1|-27.7||p-value adjusted for multiple comparisons with Hochberg adjustment. At least one primary outcome for each of drug liking and high was required to be significant with adjusted p-value less than or equal to 0.05.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-27.7|-42.1|<0.0001
70984644|NCT01380093|141478043|SUPERIORITY_OR_OTHER||LS Mean Difference|27.2|||<|0.0001|TWO_SIDED|95.0|20.1|34.4||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||34.4|20.1|<0.0001
70984645|NCT01380093|141478043|SUPERIORITY_OR_OTHER||LS Mean Difference|62.1|||<|0.0001|TWO_SIDED|95.0|54.9|69.4||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||69.4|54.9|<0.0001
70984646|NCT01380093|141478044|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.1||||0.0039|TWO_SIDED|95.0|-58.5|-11.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-11.7|-58.5|0.0039
70984647|NCT01380093|141478044|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3||||0.1026|TWO_SIDED|95.0|-4.0|42.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||42.7|-4.0|0.1026
70984648|NCT01380093|141478044|SUPERIORITY_OR_OTHER||LS Mean Difference|54.4|||<|0.0001|TWO_SIDED|95.0|31.0|77.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||77.8|31.0|<0.0001
70984649|NCT01380093|141478045|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.3||||0.0051|TWO_SIDED|95.0|-73.1|-13.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-13.5|-73.1|0.0051
71037510|NCT02554877|141582181|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.39|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.52|-0.26||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 2.||-0.26|-0.52|<0.0001
71037511|NCT02554877|141582181|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.44|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.57|-0.3||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 2.||-0.30|-0.57|<0.0001
70984650|NCT01380093|141478045|SUPERIORITY_OR_OTHER||LS Mean Difference|25.3||||0.0941|TWO_SIDED|95.0|-4.4|55.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||55.0|-4.4|0.0941
70984651|NCT01380093|141478045|SUPERIORITY_OR_OTHER||LS Mean Difference|68.6|||<|0.0001|TWO_SIDED|95.0|38.8|98.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||98.4|38.8|<0.0001
70984652|NCT01380093|141478046|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.0||||0.0083|TWO_SIDED|95.0|-85.0|-13.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-13.1|-85.0|0.0083
70984653|NCT01380093|141478046|SUPERIORITY_OR_OTHER||LS Mean Difference|32.3||||0.0766|TWO_SIDED|95.0|-3.5|68.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||68.1|-3.5|0.0766
70984654|NCT01380093|141478046|SUPERIORITY_OR_OTHER||LS Mean Difference|81.3|||<|0.0001|TWO_SIDED|95.0|45.4|117.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||117.3|45.4|<0.0001
70984655|NCT01380093|141478047|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.0||||0.0018|TWO_SIDED|95.0|-12.9|-3.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-3.1|-12.9|0.0018
71097693|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|1.3|||||TWO_SIDED|95.0|0.98|1.63||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.63|0.98|
70984656|NCT01380093|141478047|SUPERIORITY_OR_OTHER||LS Mean Difference|4.8||||0.0527|TWO_SIDED|95.0|-0.1|9.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||9.7|-0.1|0.0527
70984657|NCT01380093|141478047|SUPERIORITY_OR_OTHER||LS Mean Difference|12.8|||<|0.0001|TWO_SIDED|95.0|7.9|17.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||17.7|7.9|<0.0001
70984658|NCT01380093|141478048|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.3986|TWO_SIDED|95.0|-1.4|0.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.6|-1.4|0.3986
70984659|NCT01380093|141478048|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5||||0.0023|TWO_SIDED|95.0|0.6|2.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.5|0.6|0.0023
70984660|NCT01380093|141478048|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9||||0.0002|TWO_SIDED|95.0|1.0|2.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.9|1.0|0.0002
70984661|NCT01380093|141478049|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.2||||0.0029|TWO_SIDED|95.0|-18.0|-4.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-4|-18|0.0029
70984662|NCT01380093|141478049|SUPERIORITY_OR_OTHER||LS Mean Difference|8.1||||0.0286|TWO_SIDED|95.0|1.0|15.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||15|1|0.0286
70984663|NCT01380093|141478049|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3|||<|0.0001|TWO_SIDED|95.0|12.0|27.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||27|12|<0.0001
70984664|NCT01380093|141478050|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.0||||0.005|TWO_SIDED|95.0|-22.0|-4.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-4|-22|0.0050
70984665|NCT01380093|141478050|SUPERIORITY_OR_OTHER||LS Mean Difference|8.2||||0.07|TWO_SIDED|95.0|-1.0|17.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||17|-1|0.0700
70984666|NCT01380093|141478050|SUPERIORITY_OR_OTHER||LS Mean Difference|21.2|||<|0.0001|TWO_SIDED|95.0|12.0|30.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||30|12|<0.0001
70984667|NCT01380093|141478051|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|||<|0.0001|TWO_SIDED|95.0|0.5|0.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.9|0.5|<0.0001
70984668|NCT01380093|141478051|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-0.3|-0.8|<0.0001
70984669|NCT01380093|141478051|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.5|-1.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-1.0|-1.5|<0.0001
70984670|NCT01380093|141478052|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4|||<|0.0001|TWO_SIDED|95.0|1.9|2.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.9|1.9|<0.0001
70984671|NCT01380093|141478052|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.2|-1.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-1.3|-2.2|<0.0001
70984672|NCT01380093|141478052|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.1|||<|0.0001|TWO_SIDED|95.0|-4.6|-3.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-3.6|-4.6|<0.0001
70984673|NCT01380093|141478053|SUPERIORITY_OR_OTHER||LS Mean Difference|4.9|||<|0.0001|TWO_SIDED|95.0|3.9|5.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||5.8|3.9|<0.0001
70984674|NCT01380093|141478053|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.3|||<|0.0001|TWO_SIDED|95.0|-6.3|-4.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-4.3|-6.3|<0.0001
70984675|NCT01380093|141478053|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.1|||<|0.0001|TWO_SIDED|95.0|-11.1|-9.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-9.2|-11.1|<0.0001
70984676|NCT01380093|141478054|SUPERIORITY_OR_OTHER||LS Mean Difference|8.6|||<|0.0001|TWO_SIDED|95.0|6.6|10.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||10.7|6.6|<0.0001
70984677|NCT01380093|141478054|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.8|||<|0.0001|TWO_SIDED|95.0|-15.9|-11.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-11.8|-15.9|<0.0001
70984678|NCT01380093|141478054|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.4|||<|0.0001|TWO_SIDED|95.0|-24.5|-20.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-20.4|-24.5|<0.0001
70984679|NCT01380093|141478055|SUPERIORITY_OR_OTHER||LS Mean Difference|11.7|||<|0.0001|TWO_SIDED|95.0|8.7|14.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||14.7|8.7|<0.0001
70984680|NCT01380093|141478055|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.5|||<|0.0001|TWO_SIDED|95.0|-24.5|-18.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-18.6|-24.5|<0.0001
70984681|NCT01380093|141478055|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.2|||<|0.0001|TWO_SIDED|95.0|-36.2|-30.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-30.2|-36.2|<0.0001
70984682|NCT01380093|141478056|SUPERIORITY_OR_OTHER||LS Mean Difference|17.5|||<|0.0001|TWO_SIDED|95.0|11.6|23.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||23.3|11.6|<0.0001
70984683|NCT01380093|141478056|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.7|||<|0.0001|TWO_SIDED|95.0|-43.6|-31.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-31.9|-43.6|<0.0001
70984684|NCT01380093|141478056|SUPERIORITY_OR_OTHER||LS Mean Difference|-55.2|||<|0.0001|TWO_SIDED|95.0|-61.1|-49.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-49.3|-61.1|<0.0001
70984685|NCT01380093|141478057|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|||<|0.0001|TWO_SIDED|95.0|0.8|1.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.4|0.8|<0.0001
70984686|NCT01380093|141478057|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.1|-1.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-1.5|-2.1|<0.0001
70984687|NCT01380093|141478057|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.9|||<|0.0001|TWO_SIDED|95.0|-3.2|-2.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-2.6|-3.2|<0.0001
70984688|NCT01380093|141478058|SUPERIORITY_OR_OTHER||LS Mean Difference|2.5||||0.0262|TWO_SIDED|95.0|0.3|4.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.6|0.3|0.0262
70984689|NCT01380093|141478058|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9||||0.418|TWO_SIDED|95.0|-1.3|3.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||3.0|-1.3|0.4180
70984690|NCT01380093|141478058|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6||||0.1479|TWO_SIDED|95.0|-3.7|0.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.6|-3.7|0.1479
70984691|NCT01380093|141478059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.21||||0.0181|TWO_SIDED|90.0|0.07|0.35|||Mixed Models Analysis|||Tmax was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.35|0.07|0.0181
70984692|NCT01380093|141478060|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.75|||<|0.0001|TWO_SIDED|90.0|0.68|0.83|||Mixed Models Analysis|||Natural log transformed Cmax was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.83|0.68|<0.0001
70984693|NCT01380093|141478061|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.77||||0.0004|TWO_SIDED|90.0|0.69|0.86|||Mixed Models Analysis|||Natural log transformed AUC (0-1) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.86|0.69|0.0004
70984694|NCT01380093|141478062|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.86||||0.0065|TWO_SIDED|90.0|0.79|0.94|||Mixed Models Analysis|||Natural log transformed AUC (0-2) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.94|0.79|0.0065
70984695|NCT01380093|141478063|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.98||||0.6399|TWO_SIDED|90.0|0.91|1.06|||Mixed Models Analysis|||Natural log transformed AUC (0-4) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.06|0.91|0.6399
70984696|NCT01380093|141478064|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.0||||0.9057|TWO_SIDED|90.0|0.94|1.08|||Mixed Models Analysis|||Natural log transformed AUC (0-8) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.08|0.94|0.9057
70984697|NCT01380093|141478065|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.03||||0.425|TWO_SIDED|90.0|0.97|1.1|||Mixed Models Analysis|||Natural log transformed AUC (0-12) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.10|0.97|0.4250
70984698|NCT01380093|141478066|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.1||||0.0204|TWO_SIDED|90.0|1.03|1.18|||Mixed Models Analysis|||Natural log transformed AUC (0-24) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.18|1.03|0.0204
70984699|NCT01380093|141478067|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.32||||0.0005|TWO_SIDED|90.0|1.17|1.49|||Mixed Models Analysis|||Natural log transformed AUC (0-∞) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.49|1.17|0.0005
70984700|NCT03237845|141478128|SUPERIORITY||Risk Difference (RD)|7.6||||0.0006|TWO_SIDED|95.0|3.3|11.9|||Cochran-Mantel-Haenszel|||||11.9|3.3|0.0006
70984701|NCT03237845|141478129|SUPERIORITY||Risk Difference (RD)|12.4|||<|0.0001|TWO_SIDED|95.0|6.9|17.9|||Cochran-Mantel-Haenszel|||||17.9|6.9|< 0.0001
70984702|NCT03237845|141478130|SUPERIORITY||Risk Difference (RD)|15.1|||<|0.0001|TWO_SIDED|95.0|9.4|20.8|||Cochran-Mantel-Haenszel|||||20.8|9.4|< 0.0001
70984703|NCT03237845|141478131|SUPERIORITY||Risk Difference (RD)|9.9||||0.0039|TWO_SIDED|95.0|3.2|16.6|||Cochran-Mantel-Haenszel|||||16.6|3.2|0.0039
70984704|NCT03237845|141478132|SUPERIORITY||Risk Difference (RD)|15.3|||<|0.0001|TWO_SIDED|95.0|9.4|21.2|||Cochran-Mantel-Haenszel|||||21.2|9.4|< 0.0001
70984705|NCT03237845|141478133|SUPERIORITY||Risk Difference (RD)|4.8||||0.2084|TWO_SIDED|95.0|-2.7|12.2||P-Value ≥ 0.05; therefore, all secondary outcome measures listed after this outcome measure in the hierarchy were not tested.|Cochran-Mantel-Haenszel|||||12.2|-2.7|0.2084
70984706|NCT03865407|141478152|SUPERIORITY|||||||0.1839|||||||t-test, 2 sided|||||||0.1839
70984707|NCT03865407|141478153|SUPERIORITY|||||||0.3036|||||||t-test, 2 sided|||||||0.3036
70984708|NCT03865407|141478154|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
70984709|NCT03865407|141478155|SUPERIORITY|||||||0.1421|||||||t-test, 2 sided|||||||0.1421
70984710|NCT03865407|141478156|SUPERIORITY|||||||0.0022|||||||t-test, 2 sided|||||||0.0022
70984711|NCT03865407|141478157|SUPERIORITY|||||||0.3032|||||||t-test, 2 sided|||||||0.3032
70984712|NCT01645280|141478173|SUPERIORITY_OR_OTHER|||||||0.184|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.184
70984713|NCT01645280|141478173|SUPERIORITY_OR_OTHER|||||||0.13|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.130
70984714|NCT01645280|141478173|SUPERIORITY_OR_OTHER|||||||0.642|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.642
70984715|NCT01645280|141478173|SUPERIORITY_OR_OTHER|||||||0.832|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.832
70984716|NCT01645280|141478174|SUPERIORITY_OR_OTHER|||||||0.019|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.019
70984717|NCT01645280|141478174|SUPERIORITY_OR_OTHER|||||||0.025|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.025
70984718|NCT01645280|141478174|SUPERIORITY_OR_OTHER|||||||0.248|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.248
70984719|NCT01645280|141478174|SUPERIORITY_OR_OTHER|||||||0.045|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.045
71037512|NCT02554877|141582181|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.59|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.76|-0.42||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 4.||-0.42|-0.76|<0.0001
71037513|NCT02554877|141582181|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.63|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.8|-0.46||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 4.||-0.46|-0.80|<0.0001
71037514|NCT02554877|141582181|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.62|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.79|-0.46||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 4.||-0.46|-0.79|<0.0001
71097694|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.76|1.27||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.27|0.76|
71097695|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.58|1.05||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.05|0.58|
71097696|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.67|1.21||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.21|0.67|
70984720|NCT01645280|141478175|SUPERIORITY_OR_OTHER|||||||0.381|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.381
70984721|NCT01645280|141478175|SUPERIORITY_OR_OTHER|||||||0.543|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.543
70984722|NCT01645280|141478175|SUPERIORITY_OR_OTHER|||||||0.629|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.629
71097697|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.7|1.25||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.25|0.70|
71097698|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.73|1.46||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.46|0.73|
70984723|NCT01645280|141478175|SUPERIORITY_OR_OTHER|||||||0.273|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.273
70984724|NCT01645280|141478176|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.060
71037515|NCT02554877|141582181|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.71|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.93|-0.49||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model||Placebo was the reference and each of the active doses was the test for Week 8.||-0.49|-0.93|<0.0001
71037516|NCT02554877|141582181|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.96|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.17|-0.74||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects..|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 8.||-0.74|-1.17|<0.0001
71097699|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|1.1|||||TWO_SIDED|95.0|0.83|1.43||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.43|0.83|
71097700|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.7|1.2||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.20|0.70|
71097701|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.61|1.15||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.15|0.61|
70984725|NCT01645280|141478176|SUPERIORITY_OR_OTHER|||||||0.134|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.134
70984726|NCT01645280|141478176|SUPERIORITY_OR_OTHER|||||||0.28|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.280
70984727|NCT01645280|141478176|SUPERIORITY_OR_OTHER|||||||0.345|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.345
70984728|NCT00234104|141478180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09||||0.0074||95.0|||||t-test, 2 sided|Dunnett's test was used||||||0.0074
70984729|NCT00234104|141478180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.0459||95.0|||||t-test, 2 sided|Dunnett's test was used||||||0.0459
70984730|NCT00234104|141478180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32||||0.001||95.0|||||t-test, 2 sided|Dunnett's test was used||||||0.0010
70984731|NCT01088412|141478184|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.77|||||TWO_SIDED|95.0|2.24|5.96||||||Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.||5.96|2.24|
70984732|NCT01088412|141478185|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.71|||||TWO_SIDED|95.0|0.39|1.2||||||Epidemiological comparison between incidence of primary malignancies in study versus general population registry data, stratified by age and gender.||1.20|0.39|
70984733|NCT01088412|141478192|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.03|||||TWO_SIDED|95.0|2.14|4.15||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for All DM (T1, T2 and DM Not Otherwise Specified \[NOS\] Combined)"||4.15|2.14|
70984734|NCT01088412|141478192|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|2.74|||||TWO_SIDED|95.0|1.72|4.15||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for GHD DM (T1, T2 and DM NOS Combined)"||4.15|1.72|
70984735|NCT01088412|141478192|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|4.91|||||TWO_SIDED|95.0|1.8|10.69||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for TS DM (T1, T2 and DM NOS Combined)"||10.69|1.80|
70984736|NCT01088412|141478192|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.1|||||TWO_SIDED|95.0|0.84|7.93||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for ISS DM (T1, T2 and DM NOS Combined)"||7.93|0.84|
70984737|NCT01088412|141478192|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|11.83||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SHOX-D DM (T1, T2 and DM NOS Combined)"||11.83|0.00|
70984738|NCT01088412|141478192|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.0|||||TWO_SIDED|95.0|0.36|10.83||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SGA DM (T1, T2 and DM NOS Combined)"||10.83|0.36|
70984739|NCT01088412|141478192|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|4.55|||||TWO_SIDED|95.0|1.24|11.66||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Other DM (T1, T2 and DM NOS Combined)"||11.66|1.24|
70984740|NCT01088412|141478192|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|24.3||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Unknown DM (T1, T2 and DM NOS Combined)"||24.30|0.00|
70984741|NCT01088412|141478192|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.92|||||TWO_SIDED|95.0|0.56|1.44||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for All T1 DM."||1.44|0.56|
71097702|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.51|1.15||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.15|0.51|
70984742|NCT01088412|141478192|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.76|||||TWO_SIDED|95.0|0.36|1.4||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for GHD T1DM."||1.40|0.36|
70984743|NCT01088412|141478192|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|1.5|||||TWO_SIDED|95.0|0.31|4.38||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for TS T1DM."||4.38|0.31|
70984744|NCT01088412|141478192|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|1.42|||||TWO_SIDED|95.0|0.29|4.14||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for ISS T1DM."||4.14|0.29|
71097703|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|0.7|||||TWO_SIDED|95.0|0.46|1.03||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.03|0.46|
71097704|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.56|1.44||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.44|0.56|
71097705|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.74|1.37||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.37|0.74|
71097706|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.67|1.23||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.23|0.67|
71097707|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.63|1.29||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.29|0.63|
71097708|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|3.1|||||TWO_SIDED|95.0|2.4|4.06||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.06|2.40|
71097709|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|0.5|||||TWO_SIDED|95.0|0.39|0.66||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.66|0.39|
71097710|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|0.2|||||TWO_SIDED|95.0|0.12|0.22||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.22|0.12|
70984745|NCT01088412|141478192|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|7.23||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SHOX-D T1DM."||7.23|0.00|
70984746|NCT01088412|141478192|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|3.38||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SGA T1DM."||3.38|0.00|
70984747|NCT01088412|141478192|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio]|2.09|||||TWO_SIDED|95.0|0.43|6.1||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Other T1DM."||6.10|0.43|
70984748|NCT01088412|141478192|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio]|0.0|||||TWO_SIDED|95.0|0.0|14.84||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Unknown T1DM."||14.84|0.00|
70984749|NCT01088412|141478192|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.79|||||TWO_SIDED|95.0|2.24|5.96||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for All T2 DM."||5.96|2.24|
70984750|NCT01088412|141478192|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.93|||||TWO_SIDED|95.0|2.03|6.87||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for GHD T2DM."||6.87|2.03|
70984751|NCT01088412|141478192|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|6.46|||||TWO_SIDED|95.0|1.33|18.89||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for TS T2DM."||18.89|1.33|
70984752|NCT01088412|141478192|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|7.52||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for ISS T2DM."||7.52|0.00|
70984753|NCT01088412|141478192|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|31.16||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SHOX-D T2DM."||31.16|0.00|
70984754|NCT01088412|141478192|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|7.9|||||TWO_SIDED|95.0|0.96|28.52||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SGA T2DM."||28.52|0.96|
70984755|NCT01088412|141478192|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.0|||||TWO_SIDED|95.0|0.08|16.7||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Other T2DM."||16.70|0.08|
70984756|NCT01088412|141478192|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|63.97||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Unknown T2DM."||63.97|0.00|
70984757|NCT01065428|141478210|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
70984758|NCT01065428|141478211|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
70984759|NCT01507246|141478263|SUPERIORITY_OR_OTHER||Ratio of geometric means|2.62||||0.0251|TWO_SIDED|95.0|1.14|6.03|||least-squares mean ratio||Group 1 represents the numerator.|Null hypothesis: Mean ratio of geometric least-squares mean for each group is identical.||6.03|1.14|0.0251
70984760|NCT01507246|141478264|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.24||||0.02767|TWO_SIDED|95.0|1.03|1.49|||least-squares mean ratio||Group 1 represents the numerator.|Null hypothesis = distribution of costs is identical between the two groups.||1.49|1.03|0.02767
70984761|NCT00969618|141478280|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for total ADHD symptoms score.|Paired t-test|||||||<0.001
70984762|NCT00969618|141478280|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for inattention subscale score.|Paired t-test|||||||<0.001
70984763|NCT00969618|141478280|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for hyperactivity/impulsivity subscale score.|Paired t-test|||||||<0.001
70984764|NCT00969618|141478280|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for ADHD index subscale score.|Paired t-test|||||||<0.001
70984765|NCT00969618|141478281|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Paired t-test|||||||<0.001
70984766|NCT00969618|141478282|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is GEC subscale score.|Paired t-test|||||||<0.001
70984767|NCT00969618|141478282|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for behavioral regulation subscale score.|Paired t-test|||||||<0.001
70984768|NCT00969618|141478282|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for metacognition subscale score.|Paired t-test|||||||<0.001
70984769|NCT00969618|141478283|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Paired t-test|||||||0.200
70984770|NCT00969618|141478284|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Paired t-test|||||||<0.001
70984771|NCT00969618|141478285|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for GEC subscale score.|Paired t-test|||||||<0.001
70984772|NCT00969618|141478285|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for behavioral regulation subscale score.|Paired t-test|||||||<0.001
70984773|NCT00969618|141478285|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for metacognition subscale score.|Paired t-test|||||||<0.001
70984774|NCT00969618|141478286|SUPERIORITY_OR_OTHER|||||||0.384||95.0|||||Paired t-test|||||||0.384
71008537|NCT02140762|141525115|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|40.9|||||TWO_SIDED|||||||||Vaccine effectiveness\<100% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
70984775|NCT05136885|141478287|SUPERIORITY||Disease Rate Ratio|0.87|STANDARD_DEVIATION|0.111|||TWO_SIDED|95.0|0.665|1.102||Posterior probability that the disease rate ratio (DRR) is less than 1 (i.e. (Trehalose) slowed progression) was (0.8772). NOTE: p-value is not provided for Bayesian model.|Bayesian shared-parameter model|A Bayesian shared-parameter model of change in disease severity as measured by ALSFRS-R total score and mortality.|"DDR \<1 imply slowing of disease progression by Trehalose relative to placebo.Note: reported Confidence Interval is actually a Bayesian credible interval."||The DRR parameter for active treatment represents the relative change to the rate of decline of ALSFRS-R and the rate of mortality of treated participant relative to a placebo participant. The estimated DRR can also be interpreted as the average rate of decline in function and mortality. The model includes covariates for baseline use of edaravone, baseline use of riluzole, baseline use of Relyvrio, months since onset of symptoms, and pre-baseline slope of ALSFRS-R, serum NfL concentration and random effects for regimen and participant-specific slopes.|1.102|0.665|
70984776|NCT05136885|141478289|SUPERIORITY||Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|1.79||0.7607|TWO_SIDED|95.0|-4.06|2.97|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, pre-baseline ALSFRS-R slope, and baseline log-transformed NfL.|Trehalose 24-week change from baseline relative to placebo 24-week change from baseline.|||2.97|-4.06|0.7607
70984777|NCT05136885|141478290|SUPERIORITY||Mean Difference (Net)|0.92|STANDARD_ERROR_OF_MEAN|3.204||0.7737|TWO_SIDED|95.0|-5.37|7.21|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, pre-baseline ALSFRS-R slope, and baseline log-transformed NfL.|Trehalose 24-week change from baseline relative to placebo 24-week change from baseline.|||7.21|-5.37|0.7737
70984778|NCT05136885|141478291|SUPERIORITY|||||||0.2137|||||||Log Rank|||||||0.2137
70984779|NCT01438710|141478339|SUPERIORITY_OR_OTHER|||||||0.0048|TWO_SIDED|95.0|||||t-test, 2 sided|||The mean change (i.e., absolute change) from baseline (Day 7, pre-conversion) on FTM overall score to Day 14 (post-conversion) was evaluated using paired t-test (at 0.05 significance level, two sided). An estimation of mean change from baseline and the corresponding 95% confidence interval (CI) were provided.||||0.0048
70984780|NCT00128206|141478342|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.51|||>|0.05||95.0|0.13|2.01|||Chi-squared|||The null hypothesis was that there would be no difference in toxicity by study group, and a sample of 360 participants (180 in each group)was estimated to have sufficient power to detect a difference.||2.01|.13|>.05
70984781|NCT02340104|141478345|EQUIVALENCE|Geometric Least Square (LS) Means values were calculated using Log pharmacokinetic (PK) model with treatment, participant, random error as model with treatment as a fixed effect and participant and error as random effects.|Ratio of Geometric LS Means|0.789|||||TWO_SIDED|90.0|0.769|0.81|||||Geometric Least Square (LS) Means values were calculated using Log pharmacokinetic (PK) model with treatment, participant, random error as independent variables, where participant was fitted as a random effect.|||0.810|0.769|
70984782|NCT04315363|141478353|EQUIVALENCE|Two by two Mixed Analysis of Variance (ANOVA) models (i.e., within-subject effect: pre- and post- intervention \* between-subject effect: intervention and control group) were estimated to investigate the primary outcome changes (i.e., sedentary time) before and after the intervention.||||||0.8|||||||ANOVA|||||||0.8
70984783|NCT04315363|141478354|EQUIVALENCE|Two by two Mixed Analysis of Variance (ANOVA) models (i.e., within-subject effect: pre- and post- intervention \* between-subject effect: intervention and control group) were estimated to investigate the secondary outcome changes (i.e., moderate-to-vigorous physical activity) before and after the intervention.||||||0.35|||||||ANOVA|||||||0.35
70984784|NCT04655586|141478359|SUPERIORITY|||||||0.4715||||||All rNAPc2 vs. Heparin|Wilcoxon Rank Sum|||All rNAPc2 doses (lower and higher) were pooled and compared to Heparin for statistical analysis presentation.||||0.4715
70984785|NCT04655586|141478360|SUPERIORITY|||||||0.1883|||||||Wilcoxon Rank Sum|||All rNAPc2 doses (lower and higher) were pooled and compared to Heparin for statistical analysis presentation.||||0.1883
70984786|NCT04655586|141478363|SUPERIORITY|||||||1|||||||Wilcoxon Rank Sum|||All rNAPc2 doses (lower and higher) were pooled and compared to Heparin for statistical analysis presentation.||||1.0
70984787|NCT04655586|141478364|SUPERIORITY|||||||0.0254|||||||Wilcoxon Rank Sum|||All rNAPc2 doses (lower and higher) were pooled and compared to Heparin for statistical analysis presentation.||||0.0254
70984788|NCT04655586|141478365|SUPERIORITY|||||||0.0535|||||||Wilcoxon Rank Sum|||All rNAPc2 doses (lower and higher) were pooled and compared to Heparin for statistical analysis presentation.||||0.0535
70984789|NCT04655586|141478366|SUPERIORITY|||||||0.83|||||||Wilcoxon Rank Sum|||All rNAPc2 doses (lower and higher) were pooled and compared to Heparin for statistical analysis presentation.||||0.8300
70984790|NCT00201201|141478370|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic (1,161)=4.44,p=0.035).||Repeated measures linear-mixed model ANOVA methodology was employed as each participant was measured on 4 visits and the 4 repeated measures are likely dependent. We used study group (intervention vs. control) and visit as categorical variables and controlled for gender, age, APRN, income, education, computer use. Non-parametric tests (Cochran-Mantel-Haenszel statistic), based on rank scores, controlling for participant code were used for the transformed behavior risk scores within groups.||||0.035
70984791|NCT00201201|141478371|SUPERIORITY_OR_OTHER|||||||0.0204||95.0|||||ANOVA|||Repeated measures linear-mixed model ANOVA methodology was employed as each participant was measured on 4 visits and the 4 repeated measures are likely dependent. We used study group (intervention vs. control) and visit as categorical variables and controlled for gender, age, APRN, income, education, computer use.||||.0204
70984792|NCT00201201|141478372|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANOVA|||Repeated measures linear-mixed model ANOVA methodology was employed as each participant was measured on 4 visits and the 4 repeated measures are likely dependent. We used study group (intervention vs. control) and visit as categorical variables and controlled for gender, age, APRN, income, education, computer use.||||.0001
70984793|NCT00201201|141478373|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANOVA|||Repeated measures linear-mixed model ANOVA methodology was employed as each participant was measured on 4 visits and the 4 repeated measures are likely dependent. We used study group (intervention vs. control) and visit as categorical variables and controlled for gender, age, APRN, income, education, computer use.||||0.0001
70984794|NCT00201201|141478374|SUPERIORITY_OR_OTHER|||||||0.0431||95.0|||||t-test, 2 sided|||||||0.0431
70984795|NCT00201201|141478375|SUPERIORITY_OR_OTHER||||||<|0.1||95.0|||||t-test, 2 sided|||Analyzed at 0 and 12 weeks.||||<.10
71097711|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|1.4|||||TWO_SIDED|95.0|1.11|1.78||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.78|1.11|
70984796|NCT01342640|141478380|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Change from baseline in mean Hb levels at Week 20 was analyzed using paired t-test.||||<0.0001
70984797|NCT01342640|141478381|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Change from baseline in mean Hb levels at Week 24 was analyzed using paired t-test.||||<.0001
70984798|NCT01342640|141478382|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Change from baseline in mean Hb levels at Week 28 was analyzed using paired t-test.||||<.0001
71097712|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.66|1.06||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.06|0.66|
71097713|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|0.6|||||TWO_SIDED|95.0|0.45|0.78||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.78|0.45|
71097714|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|1.2|||||TWO_SIDED|95.0|0.84|1.62||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.62|0.84|
71097715|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|0.6|||||TWO_SIDED|95.0|0.45|0.87||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.87|0.45|
71097716|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|0.5|||||TWO_SIDED|95.0|0.36|0.79||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.79|0.36|
71097717|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.71|1.4||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.40|0.71|
71097718|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.66|1.31||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.31|0.66|
71097719|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.63|1.39||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.39|0.63|
71097720|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|0.5|||||TWO_SIDED|95.0|0.41|0.7||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.70|0.41|
71097721|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|1.1|||||TWO_SIDED|95.0|0.82|1.38||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.38|0.82|
70984799|NCT01745055|141478383|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|103.06|||||TWO_SIDED|90.0|99.0|107.29||||||Natural log transformed, AUC (0-12) of CP-690,550 was analyzed using mixed effect model with treatment as fixed effects and participant as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||107.29|99.00|
70984800|NCT01745055|141478384|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|102.71|||||TWO_SIDED|90.0|93.79|112.47||||||Natural log transformed, Cmax of CP-690,550 was analyzed using mixed effect model with treatment as fixed effects and participant as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||112.47|93.79|
70984801|NCT01745055|141478385|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|89.53|||||TWO_SIDED|90.0|77.38|103.57||||||Natural log transformed, AUClast of MTX was analyzed using mixed effect model with treatment as fixed effects and participant as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||103.57|77.38|
70984802|NCT01745055|141478386|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|87.25|||||TWO_SIDED|90.0|76.03|100.12||||||Natural log transformed, Cmax of MTX was analyzed using mixed effect model with treatment as fixed effects and participant as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||100.12|76.03|
70984803|NCT03472534|141478411|OTHER|The p-value for the overall F-test was used to determine if the mean irritation scores were equal for all four products.|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
70984804|NCT02052960|141478462|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.86|TWO_SIDED|95.0|0.736|1.359|||Log Rank|||||1.359|0.736|0.86
70984805|NCT02052960|141478463|SUPERIORITY||Mean Difference (Net)|-1.9||||0.77|TWO_SIDED|95.0|-14.5|10.7|||Chi-squared|||||10.7|-14.5|0.77
70984806|NCT02052960|141478464|SUPERIORITY||Mean Difference (Net)|-1.21||||0.83|TWO_SIDED|95.0|-12.05|9.63|||Chi-squared|||||9.63|-12.05|0.83
70984807|NCT02052960|141478465|SUPERIORITY||Hazard Ratio (HR)|1.057||||0.7|TWO_SIDED|95.0|0.814|1.372|||Log Rank|||||1.372|0.814|0.70
70984808|NCT02052960|141478466|SUPERIORITY||Hazard Ratio (HR)|1.012||||0.96|TWO_SIDED|95.0|0.734|1.396|||Log Rank|||||1.396|0.734|0.96
70984809|NCT03849560|141478468|NON_INFERIORITY|Odds ratio was calculated to compare seroconversion for antigen H1N1 in group Grippol® Quadri and groups Grippol® Plus, trivalent (Yamagata lineage)+Grippol® Plus, trivalent (Victoria lineage)|Odds Ratio, log|1.22|||||TWO_SIDED|95.0|0.82|1.82||||||||1.82|0.82|
70984810|NCT03849560|141478468|NON_INFERIORITY|Odds ratio was calculated to compare seroconversion for antigen H3N2 in group Grippol® Quadri and groups Grippol® Plus, trivalent (Yamagata lineage)+Grippol® Plus, trivalent (Victoria lineage)|Odds Ratio, log|1.54|||||TWO_SIDED|95.0|1.08|2.3||||||||2.30|1.08|
71097722|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|2.0|||||TWO_SIDED|95.0|1.46|2.69||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.69|1.46|
71097723|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.74|1.28||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.28|0.74|
70984811|NCT03849560|141478468|NON_INFERIORITY|Odds ratio was calculated to compare seroconversion for YAMA antigen in group Grippol® Quadri and group Grippol® Plus, trivalent (Yamagata lineage)|Odds Ratio, log|1.39|||||TWO_SIDED|95.0|0.9|2.15||||||||2.15|0.90|
70984812|NCT03849560|141478468|NON_INFERIORITY|Odds ratio was calculated to compare seroconversion for VICT antigen in group Grippol® Quadri and group Grippol® Plus, trivalent (Victoria lineage)|Odds Ratio, log|1.05|||||TWO_SIDED|95.0|0.68|1.63||||||||1.63|0.68|
70984813|NCT03849560|141478469|NON_INFERIORITY|The Grippol® Quadri vaccine considered non-inferior to Grippol® Plus, trivalent (Yamagata lineage) and Grippol® Plus, trivalent (Victoria lineage) vaccines for the strain A/H1N1 if the upper limit of the two-sided 95% Confidence Interval (CI) of the ratio of means of geometric antibody titers for H1N1 was ≤1.5|Mean Difference (Final Values)|0.8933|||||TWO_SIDED|95.0|0.7762|1.03||||||Non-inferiority of Grippol® Quadri over Grippol® Plus, trivalent (Yamagata lineage) and Grippol® Plus, trivalent (Victoria lineage) for the strain A/H1N1||1.030|0.7762|
70984814|NCT03849560|141478469|NON_INFERIORITY|The Grippol® Quadri vaccine considered non-inferior to Grippol® Plus, trivalent (Yamagata lineage) and Grippol® Plus, trivalent (Victoria lineage) vaccines for the strain A/H3N2 if the upper limit of the two-sided 95% CI of the ratio of means of geometric antibody titers for H3N2 was ≤1.5|Median Difference (Final Values)|0.8913|||||TWO_SIDED|95.0|0.7516|1.0593||||||Non-inferiority of Grippol® Quadri over Grippol® Plus, trivalent (Yamagata lineage) and Grippol® Plus, trivalent (Victoria lineage) for the strain A/H3N2||1.0593|0.7516|
70984815|NCT03849560|141478469|NON_INFERIORITY|The Grippol® Quadri vaccine considered non-inferior to Grippol® Plus, trivalent (Yamagata lineage) vaccine for the strain B/Yamagata if the upper limit of the two-sided 95% CI of the ratio of means of geometric antibody titers for Yamagata antigen was ≤1|Mean Difference (Final Values)|0.8185|||||TWO_SIDED|95.0|0.6918|0.9683||||||Non-inferiority of Grippol® Quadri over Grippol® Plus, trivalent (Yamagata lineage) for the strain B/Yamagata||0.9683|0.6918|
70984816|NCT03849560|141478469|NON_INFERIORITY|The Grippol® Quadri vaccine considered non-inferior to Grippol® Plus, trivalent (Victoria lineage) vaccine for the strain B/Victoria if the upper limit of the two-sided 95% CI of the ratio of means of geometric antibody titers for Victoria antigen was ≤1|Mean Difference (Final Values)|1.0328||||0.05|TWO_SIDED|95.0|0.857|1.2445|||ANCOVA|||Non-inferiority of Grippol® Quadri over Grippol® Plus, trivalent (Victoria lineage) for the strain B/Victoria||1.2445|0.8570|0.05
70984817|NCT03849560|141478470|NON_INFERIORITY|Seroprotection for strain A/H1N1 in Grippol® Quadri group in comparison to Grippol® Plus, trivalent (Yamagata lineage)+Grippol® Plus, trivalent (Victoria lineage) groups||||||0.758|||||||Fisher Exact|||||||0.758
70984818|NCT03849560|141478470|NON_INFERIORITY|Seroprotection for strain A/H3N2 in Grippol® Quadri group in comparison to Grippol® Plus, trivalent (Yamagata lineage)+Grippol® Plus, trivalent (Victoria lineage) groups||||||0.282|||||||Fisher Exact|||||||0.282
70984819|NCT03849560|141478470|NON_INFERIORITY|Seroprotection for strain B/Yamagata in Grippol® Quadri group in comparison to Grippol® Plus, trivalent (Yamagata lineage) group||||||0.352|||||||Fisher Exact|||||||0.352
70984820|NCT03849560|141478470|NON_INFERIORITY|Seroprotection for strain B/Victoria in Grippol® Quadri group in comparison to Grippol® Plus, trivalent (Victoria lineage) group||||||0.815|||||||Fisher Exact|||||||0.815
70984821|NCT03849560|141478471|OTHER|||||||0.452|||||||Log Rank|||||||0.452
70984822|NCT03849560|141478471|OTHER|||||||0.639|||||||Log Rank|||||||0.639
70984823|NCT03849560|141478473|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H1N1 should be ˃ 2.5|Coefficient of increase of mean geometri|4.86|||||TWO_SIDED|95.0|4.22|5.6||||||Coefficient of increase of mean geometric antibody titer for H1N1 in Grippol® Quadri group||5.60|4.22|
70984824|NCT03849560|141478473|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H3N2 should be ˃ 2.5|Coefficient of increase of GMT|5.32|||||TWO_SIDED|95.0|4.53|6.24||||||Coefficient of increase of mean geometric antibody titer for H3N2 in Grippol® Quadri group||6.24|4.53|
70984825|NCT03849560|141478473|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for Yamagata should be ˃ 2.5|Coefficient of increase of GMT|5.47|||||TWO_SIDED|95.0|4.78|6.25||||||Coefficient of increase of mean geometric antibody titer for Yamagata in Grippol® Quadri group||6.25|4.78|
70984826|NCT03849560|141478473|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for Victoria should be ˃ 2.5|Coefficient of increase of GMT|4.77|||||TWO_SIDED|95.0|4.14|5.49||||||Coefficient of increase of mean geometric antibody titer for Victoria in Grippol® Quadri group||5.49|4.14|
70984827|NCT03849560|141478473|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H1N1 should be ˃ 2.5|Coefficient of increase of GMT|4.21|||||TWO_SIDED|95.0|3.59|4.94||||||Coefficient of increase of mean geometric antibody titer for H1N1 in Grippol® Plus, trivalent (Yamagata lineage) group||4.94|3.59|
70984828|NCT03849560|141478473|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H3N2 should be ˃ 2.5|Coefficient of increase of GMT|5.22|||||TWO_SIDED|95.0|4.45|6.12||||||Coefficient of increase of mean geometric antibody titer for H3N2 in Grippol® Plus, trivalent (Yamagata lineage) group||6.12|4.45|
70984829|NCT03849560|141478473|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for Yamagata should be ˃ 2.5|Coefficient of increase of GMT|4.04|||||TWO_SIDED|95.0|3.48|4.69||||||Coefficient of increase of mean geometric antibody titer for Yamagata in Grippol® Plus, trivalent (Yamagata lineage) group||4.69|3.48|
70984830|NCT03849560|141478473|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H1N1 should be ˃ 2.5|Coefficient of increase of GMT|4.6|||||TWO_SIDED|95.0|3.97|5.34||||||Coefficient of increase of mean geometric antibody titer for H1N1 in Grippol® Plus, trivalent (Victoria lineage) group||5.34|3.97|
70984831|NCT03849560|141478473|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H3N2 should be ˃ 2.5|Coefficient of increase of GMT|5.17|||||TWO_SIDED|95.0|4.38|6.12||||||Coefficient of increase of mean geometric antibody titer for H3N2 in Grippol® Plus, trivalent (Victoria lineage) group||6.12|4.38|
71037517|NCT02554877|141582181|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.98|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.2|-0.76||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 8.||-0.76|-1.20|<0.0001
70984832|NCT03849560|141478473|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for Victoria should be ˃ 2.5|Coefficient of increase of GMT|4.72|||||TWO_SIDED|95.0|4.0|5.56||||||Coefficient of increase of mean geometric antibody titer for Victoria in Grippol® Plus, trivalent (Victoria lineage) group||5.56|4.00|
71097724|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.59|1.02||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.02|0.59|
71097725|NCT01026038|141703962|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.58|1.1||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.10|0.58|
71097726|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.5|6.7||||||Serotype 4: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.7|-3.5|
71097727|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.5||||||Serotype 4: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-3.6|
71097728|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.8|6.6||||||Serotype 4: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-6.8|
71097729|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.7|6.3||||||Serotype 6B: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.3|-3.7|
71097730|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-3.6|6.4||||||Serotype 6B: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.4|-3.6|
71097731|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.4|6.5||||||Serotype 6B: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-6.4|
71097732|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.6||||||Serotype 9V: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-3.6|
70984833|NCT01678846|141478531|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4|||<|0.0001|TWO_SIDED|95.0|0.26|0.64|||Regression, Logistic||An odds ratio of less than 1 would demonstrate a protective effect of the intervention. Unadjusted odds ratio presented, accounting for correlation between students within schools.|Does the Toolkit intervention reduce physical violence from school staff to Ugandan primary school students.||0.64|0.26|<0.0001
70984834|NCT01507545|141478540|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.7335|TWO_SIDED|95.0|0.76|1.67|||One-sided log-rank test|||||1.67|0.76|0.7335
70984835|NCT01507545|141478541|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.9498|TWO_SIDED|95.0|0.93|2.19|||One-sided log-rank test|||||2.19|0.93|0.9498
70984836|NCT01507545|141478542|SUPERIORITY||Difference of arms|-2.4||||0.333|TWO_SIDED|95.0|-6.992|2.23|||Fisher Exact|||||2.230|-6.992|0.333
70984837|NCT00553787|141478552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|0.328|<|0.0001|TWO_SIDED|95.0|7.96|9.25||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||9.25|7.96|<0.0001
70984838|NCT00553787|141478552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.58|STANDARD_ERROR_OF_MEAN|0.403|<|0.0001|TWO_SIDED|95.0|5.79|7.37||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||7.37|5.79|<0.0001
70984839|NCT00553787|141478552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03|STANDARD_ERROR_OF_MEAN|0.402|<|0.0001|TWO_SIDED|95.0|1.24|2.82||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||2.82|1.24|<0.0001
70984840|NCT00553787|141478553|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.03|STANDARD_ERROR_OF_MEAN|0.955|<|0.0001|TWO_SIDED|95.0|7.34|11.11||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||11.11|7.34|<0.0001
70984841|NCT00553787|141478553|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.27|STANDARD_ERROR_OF_MEAN|0.768|<|0.0001|TWO_SIDED|95.0|4.93|7.97||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||7.97|4.93|<0.0001
70984842|NCT00553787|141478553|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44|STANDARD_ERROR_OF_MEAN|0.169||0.0018|TWO_SIDED|95.0|1.15|1.81||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||1.81|1.15|0.0018
70984843|NCT02285010|141478554|NON_INFERIORITY|Definition: 50% reduction of morphine consumption Type I error (alpha) 0.05, Type II error (beta) 80%||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.60
70984844|NCT02285010|141478555|NON_INFERIORITY|Alpha 0.05, Beta 80%||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||0.10
70984845|NCT02285010|141478556|NON_INFERIORITY|alpha 0.05, beta 80%||||||0.33|||||||Wilcoxon (Mann-Whitney)|||for NRS at rest||||0.33
70984846|NCT02285010|141478556|NON_INFERIORITY|alpha 0.05, beta 80%||||||0.75|||||||Wilcoxon (Mann-Whitney)|||for NRS at movement||||0.75
70984847|NCT02285010|141478557|NON_INFERIORITY|alpha 0.05, beta 80%||||||0.16|||||||Chi-squared|||For pruritus||||0.16
70984848|NCT02285010|141478557|NON_INFERIORITY|Alpha 0.05, beta 80%||||||0.66|||||||Chi-squared|||For Nausea||||0.66
71097733|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.5||||||Serotype 9V: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-3.6|
70984849|NCT02285010|141478557|NON_INFERIORITY|alpha 0.05, beta 80%||||||0.46|||||||Chi-squared|||For Vomiting||||0.46
71097734|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.7|6.5||||||Serotype 9V: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-6.7|
71097735|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.7|6.6||||||Serotype 14: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-3.7|
71097736|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.7|6.5||||||Serotype 14: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-3.7|
70984850|NCT02285010|141478557|NON_INFERIORITY|Alpha 0.05, beta 80%||||||0.54|||||||Chi-squared|||For Dizziness||||0.54
70984851|NCT02285010|141478557|NON_INFERIORITY|Alpha 0.05, beta 80%||||||0.05|||||||Chi-squared|||For visual disturbance||||0.05
70984852|NCT02285010|141478558|NON_INFERIORITY|Alpha 0.05, beta 80%||||||0.05||||||P-Value 0.05 was calculated.|Chi-squared|||||||0.05
70984853|NCT01426386|141478561|OTHER|Based on the ANCOVA model the slope of the dose-response curve was estimated. Null hypothesis: Slope of dose-response curve equal to 0 (zero)|Slope of the dose-response curve|7.9|||<|0.001|TWO_SIDED|95.0|5.69|10.18||The a priori threshold for statistical significance was 5% (two-sided)|ANCOVA|Number of oocytes retrieved as dependent variable, centre and AMH strata (5.0-14.9 pmol/L and 15.0-44.9 pmol/L) as factors and log(dose) as covariate||The dose-response relationship was analysed using an analysis of covariance (ANCOVA) model||10.18|5.69|<0.001
70984854|NCT01426386|141478562|OTHER|Based on the ANCOVA model the slope of the dose-response curve was estimated. Null hypothesis: Slope of dose-response curve equal to 0 (zero)|Slope of the dose-response curve|11.1|||<|0.001|TWO_SIDED|95.0|6.78|15.48||No adjustment for multiplicity was applied for the secondary endpoints|ANCOVA|Follicular volume as dependent variable, centre and AMH strata (5.0-14.9 pmol/L and 15.0-44.9 pmol/L) as factors and log(dose) as covariate||The dose-response relationship was analysed using an analysis of covariance (ANCOVA) model||15.48|6.78|<0.001
70984855|NCT01426386|141478563|OTHER|Based on the ANCOVA model the slope of the dose-response curve was estimated. Null hypothesis: Slope of dose-response curve equal to 0 (zero)|Slope of the dose-response curve|0.8|||<|0.001|TWO_SIDED|95.0|0.56|1.11||No adjustment for multiplicity was applied for the secondary endpoints|ANCOVA|Log(estradiol) as dependent variable, AMH strata (5.0-14.9 pmol/L and 15.0-44.9 pmol/L) as factor, log(dose) and log(baseline estradiol) as covariates||The dose-response relationship was analysed using an analysis of covariance (ANCOVA) model||1.11|0.56|<0.001
70984856|NCT01426386|141478565|OTHER|Based on the ANCOVA model the slope of the dose-response curve was estimated. Null hypothesis: Slope of dose-response curve equal to 0 (zero)|Slope of the dose-response curve|3.2|||<|0.001|TWO_SIDED|95.0|1.71|4.78||No adjustment for multiplicity was applied for the secondary endpoints|ANCOVA|Fertilised oocytes as dependent variable, AMH strata (5.0-14.9 pmol/L and 15.0-44.9 pmol/L) as factor and log(dose) as covariate||The dose-response relationship was analysed using an analysis of covariance (ANCOVA) model||4.78|1.71|<0.001
70984857|NCT01426386|141478567|OTHER|Treatment groups were compared using the chi-squared test.||||||0.248||||||No adjustment for multiplicity was applied for the secondary endpoints|Chi-squared|||||||0.248
70984858|NCT00196937|141478569|NON_INFERIORITY|Non-inferiority with respect to seroconversion was shown if, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the difference \[Cervarix (15-25 years) Group minus Cervarix (26-45 years) Group\] was below 10%.|Difference in SCR|0.0|||||TWO_SIDED|95.0|-1.97|2.29||||||Immune response to anti-HPV-16 in terms of SCR: To evaluate if the immunogenicity (as determined by ELISA) of the Cervarix vaccine, one month after the third dose (Month 7), in young women 26 - 45 years of age is non-inferior to that in women 15 - 25 years of age.||2.29|-1.97|
70984859|NCT00196937|141478569|NON_INFERIORITY|Non-inferiority with respect to seroconversion was shown if, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the difference \[Cervarix (15-25 years) Group minus Cervarix (26-45 years) Group\] was below 10%.|Difference in SCR|0.0|||||TWO_SIDED|95.0|-1.87|2.03||||||Immune response to anti-HPV-18 in terms of SCR: To evaluate if the immunogenicity (as determined by ELISA) of the Cervarix vaccine, one month after the third dose (Month 7), in young women 26 - 45 years of age is non-inferior to that in women 15 - 25 years of age.||2.03|-1.87|
70984860|NCT01096667|141478584|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.97||||0.034|TWO_SIDED|80.0|-5.05|-0.89||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-0.89|-5.05|0.034
70984861|NCT01096667|141478584|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.0||||0.01|TWO_SIDED|80.0|-6.17|-1.82||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.82|-6.17|0.010
71037518|NCT02554877|141582182|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-37.83|STANDARD_ERROR_OF_MEAN|5.13|<|0.0001|TWO_SIDED|95.0|-47.96|-27.7||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||-27.70|-47.96|<0.0001
70984862|NCT01096667|141478584|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.69||||0.012|TWO_SIDED|80.0|-5.78|-1.6||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.60|-5.78|0.012
70984863|NCT01096667|141478584|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.21||||0.024|TWO_SIDED|80.0|-5.3|-1.13||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.13|-5.30|0.024
70984864|NCT01096667|141478586|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.7||||0.018|TWO_SIDED|80.0|-5.94|-1.46||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.46|-5.94|0.018
70984865|NCT01096667|141478586|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.43||||0.008|TWO_SIDED|80.0|-6.78|-2.09||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-2.09|-6.78|0.008
70984866|NCT01096667|141478586|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.99||||0.002|TWO_SIDED|80.0|-7.24|-2.74||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-2.74|-7.24|0.002
70984867|NCT01096667|141478586|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.92||||0.013|TWO_SIDED|80.0|-6.16|-1.67||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.67|-6.16|0.013
70984868|NCT01096667|141478587|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.19||||0.152|TWO_SIDED|80.0|-4.93|0.54||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.54|-4.93|0.152
70984869|NCT01096667|141478587|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.18||||0.078|TWO_SIDED|80.0|-6.06|-0.3||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-0.30|-6.06|0.078
71037519|NCT02554877|141582182|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-44.85|STANDARD_ERROR_OF_MEAN|5.13|<|0.0001|TWO_SIDED|95.0|-54.98|-34.72||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||-34.72|-54.98|<0.0001
70984870|NCT01096667|141478587|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.02||||0.174|TWO_SIDED|80.0|-4.79|0.74||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.74|-4.79|0.174
70984871|NCT01096667|141478587|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.01||||0.174|TWO_SIDED|80.0|-4.77|0.74||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.74|-4.77|0.174
70984872|NCT01096667|141478589|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.01||||0.047|TWO_SIDED|80.0|-7.09|-0.94||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-0.94|-7.09|0.047
70984873|NCT01096667|141478589|SUPERIORITY_OR_OTHER||Difference in least squares means|-7.16||||0.002|TWO_SIDED|80.0|-10.25|-4.07||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-4.07|-10.25|0.002
70984874|NCT01096667|141478589|SUPERIORITY_OR_OTHER||Difference in least squares means|-6.2||||0.005|TWO_SIDED|80.0|-9.28|-3.11||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-3.11|-9.28|0.005
70984875|NCT01096667|141478589|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.37||||0.033|TWO_SIDED|80.0|-7.41|-1.33||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-1.33|-7.41|0.033
71097737|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.7|6.5||||||Serotype 14: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-6.7|
71097738|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.6||||||Serotype 18C: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-3.6|
70984876|NCT01096667|141478591|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.66||||0.007|TWO_SIDED|80.0|-4.03|-1.29||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-1.29|-4.03|0.007
71097739|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.7|6.3||||||Serotype 18C: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.3|-3.7|
70984877|NCT01096667|141478591|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.11||||0.003|TWO_SIDED|80.0|-4.55|-1.67||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-1.67|-4.55|0.003
70984878|NCT01096667|141478591|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.27||||0.018|TWO_SIDED|80.0|-3.65|-0.88||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-0.88|-3.65|0.018
70984879|NCT01096667|141478591|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.19||||0.021|TWO_SIDED|80.0|-3.56|-0.82||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-0.82|-3.56|0.021
70984880|NCT01096667|141478592|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.99||||0.004|TWO_SIDED|80.0|-4.43|-1.55||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-1.55|-4.43|0.004
70984881|NCT01096667|141478592|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.75||||0.01|TWO_SIDED|80.0|-4.26|-1.24||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-1.24|-4.26|0.010
70984882|NCT01096667|141478592|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.64||||0.01|TWO_SIDED|80.0|-4.09|-1.19||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-1.19|-4.09|0.010
70984883|NCT01096667|141478592|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.57||||0.011|TWO_SIDED|80.0|-4.0|-1.13||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-1.13|-4.00|0.011
70984884|NCT01096667|141478593|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.5||||0.048|TWO_SIDED|80.0|-4.43|-0.57||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-0.57|-4.43|0.048
70984885|NCT01096667|141478593|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.54||||0.013|TWO_SIDED|80.0|-5.58|-1.51||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.51|-5.58|0.013
70984886|NCT01096667|141478593|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.88||||0.111|TWO_SIDED|80.0|-3.82|0.09||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.09|-3.82|0.111
70984887|NCT01096667|141478593|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.58||||0.148|TWO_SIDED|80.0|-3.51|0.36||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.36|-3.51|0.148
70984888|NCT01096667|141478595|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.2||||0.196|TWO_SIDED|80.0|-3.01|0.6||P-value is one-sided.|Mixed Measures Repeated Model|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||0.60|-3.01|0.196
70984889|NCT01096667|141478595|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.05||||0.229|TWO_SIDED|80.0|-2.86|0.77||P-value is one-sided.|Mixed Measures Repeated Model|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||0.77|-2.86|0.229
70984890|NCT01096667|141478595|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.02||||0.017|TWO_SIDED|80.0|-4.83|-1.2||P-value is one-sided.|Mixed Measures Repeated Model|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-1.20|-4.83|0.017
71097740|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.6|6.4||||||Serotype 18C: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.4|-6.6|
71097741|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|-1.7|||||TWO_SIDED|95.0|-6.2|4.5||||||Serotype 19F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||4.5|-6.2|
71097742|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|0.1|||||TWO_SIDED|95.0|-4.8|7.5||||||Serotype 19F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||7.5|-4.8|
71097743|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|1.8|||||TWO_SIDED|95.0|-4.8|9.5||||||Serotype 19F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||9.5|-4.8|
71097744|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.5|6.7||||||Serotype 23F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.7|-3.5|
71097745|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.4||||||Serotype 23F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.4|-3.6|
71097746|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.7|6.5||||||Serotype 23F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-6.7|
71097747|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.5|6.4||||||Serotype 1: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.4|-3.5|
71097748|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.3||||||Serotype 1: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.3|-3.6|
70984891|NCT01096667|141478595|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.84||||0.021|TWO_SIDED|80.0|-4.63|-1.06||P-value is one-sided.|Mixed Measures Repeated Model|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-1.06|-4.63|0.021
70984892|NCT01096667|141478597|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.22||||0.039|TWO_SIDED|80.0|-3.83|-0.61||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-0.61|-3.83|0.039
70984893|NCT01096667|141478597|SUPERIORITY_OR_OTHER||Difference in least squares means|0.07||||0.521|TWO_SIDED|80.0|-1.63|1.77||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||1.77|-1.63|0.521
70984894|NCT01096667|141478597|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.39||||0.031|TWO_SIDED|80.0|-4.02|-0.75||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-0.75|-4.02|0.031
70984895|NCT01096667|141478597|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.56||||0.11|TWO_SIDED|80.0|-3.19|0.07||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.07|-3.19|0.110
70984896|NCT01096667|141478598|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.38||||0.007|TWO_SIDED|80.0|-5.13|-1.63||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.63|-5.13|0.007
70984897|NCT01096667|141478598|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.48||||0.37|TWO_SIDED|80.0|-2.33|1.38||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||1.38|-2.33|0.370
70984898|NCT01096667|141478598|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.65||||0.029|TWO_SIDED|80.0|-4.43|-0.87||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-0.87|-4.43|0.029
70984899|NCT01096667|141478598|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.64||||0.118|TWO_SIDED|80.0|-3.42|0.13||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.13|-3.42|0.118
70984900|NCT01096667|141478599|SUPERIORITY_OR_OTHER||Difference in least squares means|0.02||||0.506|TWO_SIDED|80.0|-1.96|2.0||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||2.00|-1.96|0.506
70984901|NCT01096667|141478599|SUPERIORITY_OR_OTHER||Difference in least squares means|1.61||||0.838|TWO_SIDED|80.0|-0.49|3.71||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||3.71|-0.49|0.838
70984902|NCT01096667|141478599|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.82||||0.123|TWO_SIDED|80.0|-3.82|0.19||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.19|-3.82|0.123
70984903|NCT01096667|141478599|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.07||||0.246|TWO_SIDED|80.0|-3.06|0.93||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.93|-3.06|0.246
71097749|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.5|6.3||||||Serotype 1: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.3|-6.5|
71097750|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|1.8|||||TWO_SIDED|95.0|-1.7|9.6||||||Serotype 3: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||9.6|-1.7|
71097751|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.7|6.2||||||Serotype 3: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.2|-3.7|
71097752|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|-1.8|||||TWO_SIDED|95.0|-9.6|4.5||||||Serotype 3: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||4.5|-9.6|
71097753|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|2.8|||||TWO_SIDED|95.0|-2.0|11.3||||||Serotype 5: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||11.3|-2.0|
71097754|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|-0.8|||||TWO_SIDED|95.0|-4.9|5.6||||||Serotype 5: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||5.6|-4.9|
70984904|NCT01096667|141478601|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.2||||0.005|TWO_SIDED|80.0|-6.3|-2.1||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-2.10|-6.30|0.005
70984905|NCT01096667|141478601|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.12||||0.248|TWO_SIDED|80.0|-3.23|0.99||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||0.99|-3.23|0.248
70984906|NCT01096667|141478601|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.84||||0.01|TWO_SIDED|80.0|-5.95|-1.73||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-1.73|-5.95|0.010
70984907|NCT01096667|141478601|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.33||||0.02|TWO_SIDED|80.0|-5.4|-1.25||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-1.25|-5.40|0.020
70984908|NCT01096667|141478603|SUPERIORITY_OR_OTHER||Difference in least squares means|42.18||||0|TWO_SIDED|80.0|31.42|52.94||P-value is one-sided. P-value rounded to thousandths.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||52.94|31.42|0.000
70984909|NCT01096667|141478603|SUPERIORITY_OR_OTHER||Difference in least squares means|60.39||||0|TWO_SIDED|80.0|49.47|71.31||P-value is one-sided. P-value rounded to thousandths.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||71.31|49.47|0.000
70984910|NCT01096667|141478603|SUPERIORITY_OR_OTHER||Difference in least squares means|70.34||||0|TWO_SIDED|80.0|59.58|81.1||P-value is one-sided. P-value rounded to thousandths.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||81.10|59.58|0.000
70984911|NCT01096667|141478603|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.63||||0.713|TWO_SIDED|80.0|-15.22|5.96||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||5.96|-15.22|0.713
70984912|NCT01096667|141478605|SUPERIORITY_OR_OTHER||Difference in least squares means|-18.1||||0.007|TWO_SIDED|80.0|-27.45|-8.75||P-value is one-sided.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||-8.75|-27.45|0.007
70984913|NCT01096667|141478605|SUPERIORITY_OR_OTHER||Difference in least squares means|-34.81||||0|TWO_SIDED|80.0|-44.19|-25.43||P-value is one-sided. P-value rounded to thousandths.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||-25.43|-44.19|0.000
70984914|NCT01096667|141478605|SUPERIORITY_OR_OTHER||Difference in least squares means|-35.42||||0|TWO_SIDED|80.0|-44.78|-26.07||P-value is one-sided. P-value rounded to thousandths.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||-26.07|-44.78|0.000
70984915|NCT01096667|141478605|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.61||||0.467|TWO_SIDED|80.0|-9.86|8.65||P-value is one-sided.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||8.65|-9.86|0.467
70984916|NCT01096667|141478606|SUPERIORITY_OR_OTHER||Difference in least squares means|-5.54||||0.224|TWO_SIDED|80.0|-14.89|3.82||P-value is one-sided.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||3.82|-14.89|0.224
70984917|NCT01096667|141478606|SUPERIORITY_OR_OTHER||Difference in least squares means|-17.0||||0.011|TWO_SIDED|80.0|-26.39|-7.61||P-value is one-sided.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||-7.61|-26.39|0.011
70984918|NCT01096667|141478606|SUPERIORITY_OR_OTHER||Difference in least squares means|-26.59||||0|TWO_SIDED|80.0|-35.84|-17.33||P-value is one-sided. P-value rounded to thousandths.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||-17.33|-35.84|0.000
70984919|NCT01096667|141478606|SUPERIORITY_OR_OTHER||Difference in least squares means|8.65||||0.886|TWO_SIDED|80.0|-0.56|17.87||P-value is one-sided.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||17.87|-0.56|0.886
71037520|NCT02554877|141582182|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-48.59|STANDARD_ERROR_OF_MEAN|5.18|<|0.0001|TWO_SIDED|95.0|-58.81|-38.37||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||-38.37|-58.81|<0.0001
71037521|NCT02554877|141582182|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-30.63|STANDARD_ERROR_OF_MEAN|6.03|<|0.0001|TWO_SIDED|95.0|-42.52|-18.74||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||-18.74|-42.52|<0.0001
71097755|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|-3.6|||||TWO_SIDED|95.0|-12.5|3.2||||||Serotype 5: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||3.2|-12.5|
71097756|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.5||||||Serotype 6A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-3.6|
71097757|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.5||||||Serotype 6A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-3.6|
71097758|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.6|6.6||||||Serotype 6A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-6.6|
71097759|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.4||||||Serotype 7F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.4|-3.6|
70984920|NCT01462292|141478609|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.946||||0.554|TWO_SIDED|95.0|-39.122|21.229||Due to the two comparisons for the two different doses, the type 1 error rate (5% overall) was preserved by utilizing a hierarchical approach, testing the 6mg/kg GSK2402968 dose first|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, centre grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 3 mg||21.229|-39.122|0.554
70984921|NCT01462292|141478609|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.099||||0.069|TWO_SIDED|95.0|-2.21|56.408||Due to the two comparisons for the two different doses, the type 1 error rate (5% overall) was preserved by utilising a hierarchical approach, testing the 6mg/kg GSK2402968 dose first|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, centre grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 6 mg||56.408|-2.210|0.069
70984922|NCT01462292|141478610|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.387||||0.699|TWO_SIDED|95.0|-1.618|2.392||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Treatment difference: Placebo Vs GSK2402968 3 mg||2.392|-1.618|0.699
70984923|NCT01462292|141478610|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.831||||0.384|TWO_SIDED|95.0|-1.072|2.735||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Treatment difference: Placebo Vs GSK2402968 6 mg||2.735|-1.072|0.384
71037522|NCT02554877|141582182|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-39.24|STANDARD_ERROR_OF_MEAN|6.03|<|0.0001|TWO_SIDED|95.0|-51.13|-27.35||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||-27.35|-51.13|<0.0001
71037523|NCT02554877|141582182|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-38.3|STANDARD_ERROR_OF_MEAN|6.04|<|0.0001|TWO_SIDED|95.0|-50.22|-26.38||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||-26.38|-50.22|<0.0001
71037524|NCT02554877|141582182|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-19.47|STANDARD_ERROR_OF_MEAN|6.29||0.0023|TWO_SIDED|95.0|-31.88|-7.05||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||-7.05|-31.88|0.0023
71037525|NCT02554877|141582182|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-36.98|STANDARD_ERROR_OF_MEAN|6.23|<|0.0001|TWO_SIDED|95.0|-49.27|-24.69||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||-24.69|-49.27|<0.0001
71037526|NCT02554877|141582182|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-35.14|STANDARD_ERROR_OF_MEAN|6.29|<|0.0001|TWO_SIDED|95.0|-47.55|-22.72||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||-22.72|-47.55|<0.0001
71037527|NCT02554877|141582182|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-19.77|STANDARD_ERROR_OF_MEAN|6.1||0.0014|TWO_SIDED|95.0|-31.81|-7.73||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||-7.73|-31.81|0.0014
71037528|NCT02554877|141582182|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-35.26|STANDARD_ERROR_OF_MEAN|6.03|<|0.0001|TWO_SIDED|95.0|-47.17|-23.35||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12||-23.35|-47.17|<0.0001
71037529|NCT02554877|141582182|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-36.44|STANDARD_ERROR_OF_MEAN|6.07|<|0.0001|TWO_SIDED|95.0|-48.43|-24.46||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12||-24.46|-48.43|<0.0001
71037530|NCT02554877|141582183|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.057||||0.0059|TWO_SIDED|95.0|1.68|21.82||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C\<7%)||21.82|1.68|0.0059
71037531|NCT02554877|141582183|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.927||||0.0008|TWO_SIDED|95.0|2.49|31.96||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C\<7%)||31.96|2.49|0.0008
71037532|NCT02554877|141582183|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|15.116|||<|0.0001|TWO_SIDED|95.0|4.34|52.67||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C\<7%)||52.67|4.34|<0.0001
71037533|NCT02554877|141582183|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.34||||0.1532|TWO_SIDED|95.0|0.64|17.47||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C\<6.5%)||17.47|0.64|0.1532
71037534|NCT02554877|141582183|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|4.198||||0.0826|TWO_SIDED|95.0|0.83|21.22||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C\<6.5%)||21.22|0.83|0.0826
71037535|NCT02554877|141582183|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.588||||0.0272|TWO_SIDED|95.0|1.21|25.73||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C\<6.5%)||25.73|1.21|0.0272
71037536|NCT02554877|141582188|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.03|STANDARD_ERROR_OF_MEAN|3.4||0.7618|TWO_SIDED|90.0|-6.66|4.59||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||4.59|-6.66|0.7618
71037537|NCT02554877|141582188|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.65|STANDARD_ERROR_OF_MEAN|3.39||0.8489|TWO_SIDED|90.0|-6.25|4.96||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||4.96|-6.25|0.8489
71037538|NCT02554877|141582188|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|2.47|STANDARD_ERROR_OF_MEAN|3.42||0.4699|TWO_SIDED|90.0|-3.17|8.12||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||8.12|-3.17|0.4699
71097760|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.5|6.6||||||Serotype 7F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-3.5|
70984924|NCT01462292|141478611|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.002||||0.997|TWO_SIDED|95.0|-0.883|0.886||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment,centre grouping and baseline||Placebo (combined) Vs GSK2402968 3 mg/kg/week, Ascent Week 24||0.886|-0.883|0.997
70984925|NCT01462292|141478611|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.803||||0.064|TWO_SIDED|95.0|-1.655|0.048||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Placebo (combined) Vs GSK2402968 6 mg/kg/week, Ascent, Week 24||0.048|-1.655|0.064
70984926|NCT01462292|141478611|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.685||||0.311|TWO_SIDED|95.0|-2.033|0.662||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Placebo (combined) Vs GSK2402968 3 mg/kg/week, Descent Week 24||0.662|-2.033|0.311
70984927|NCT01462292|141478611|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.412||||0.523|TWO_SIDED|95.0|-1.702|0.878||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Placebo (combined) Vs GSK2402968 6 mg/kg/week, Descent Week 24||0.878|-1.702|0.523
70984928|NCT01462292|141478612|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.564||||0.05|TWO_SIDED|95.0|0.0|1.127||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Treatment difference: Placebo Vs GSK2402968 3 mg||1.127|0.000|0.050
70984929|NCT01462292|141478612|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.037||||0.89|TWO_SIDED|95.0|-0.498|0.571||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, center grouping and baseline||Treatment difference: Placebo Vs GSK2402968 6 mg||0.571|-0.498|0.890
70984930|NCT01462292|141478613|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.356||||0.723|TWO_SIDED|95.0|-10.936|15.648||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model includes terms for Treatment, Centre Grouping and Baseline Muscle Strength Total Score||Treatment difference: Placebo Vs GSK2402968 3 mg||15.648|-10.936|0.723
70984931|NCT01462292|141478613|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.821||||0.898|TWO_SIDED|95.0|-12.034|13.676||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model includes terms for Treatment, Centre Grouping and Baseline Muscle Strength Total Score||Treatment difference: Placebo Vs GSK2402968 6mg||13.676|-12.034|0.898
71097761|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.5|6.7||||||Serotype 7F:Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.7|-6.5|
71097762|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.7||||||Serotype 19A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.7|-3.6|
70984932|NCT01462292|141478615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49||||0.684|TWO_SIDED|95.0|-2.9|1.92||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, center grouping and baseline||Treatment difference: Placebo Vs GSK2402968 3 mg||1.92|-2.90|0.684
70984933|NCT01462292|141478615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.873|TWO_SIDED|95.0|-2.49|2.12||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, center grouping and baseline||Treatment difference: Placebo Vs GSK2402968 6 mg||2.12|-2.49|0.873
70984934|NCT01462292|141478617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-892.88||||0.61|TWO_SIDED|95.0|-4391.1|2605.35||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, center grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 3 mg, Week 24||2605.35|-4391.10|0.610
70984935|NCT01462292|141478617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2054.86||||0.248|TWO_SIDED|95.0|-5587.33|1477.6||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, center grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 3 mg, Week 48||1477.60|-5587.33|0.248
70984936|NCT01462292|141478617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1305.46||||0.439|TWO_SIDED|95.0|-4668.41|2057.48||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, center grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 6 mg, Week 24||2057.48|-4668.41|0.439
70984937|NCT01462292|141478617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|167.39||||0.921|TWO_SIDED|95.0|-3208.98|3543.77||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, center grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 6 mg, Week 48||3543.77|-3208.98|0.921
70984938|NCT01462292|141478624|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41||||0.541|TWO_SIDED|95.0|0.02|7.01||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Regression, Logistic|Model includes terms for Treatment and Centre Grouping||Placebo (combined), GSK2402968 3 mg/kg/week||7.01|0.02|0.541
71097763|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.6||||||Serotype 19A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-3.6|
71097764|NCT01026038|141703965|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.8|6.6||||||Serotype 19A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-6.8|
71097765|NCT01227395|141703979|SUPERIORITY_OR_OTHER||||||=|0.696|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=0.696
70984939|NCT01462292|141478624|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.417|TWO_SIDED|95.0|0.03|4.27||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Regression, Logistic|Model includes terms for Treatment and Centre Grouping||Placebo (combined), GSK2402968 6 mg/kg/week||4.27|0.03|0.417
70984940|NCT01751646|141478627|OTHER|||||||0.1166||||||P-value from Wilcoxon rank sum test for change between baseline and Week 48 Vitamin D vs. Placebo|Wilcoxon (Mann-Whitney)|||||||0.1166
70984941|NCT01751646|141478629|OTHER|||||||0.8383|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.8383
70984942|NCT01751646|141478632|OTHER|||||||0.1378|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.1378
70984943|NCT01751646|141478634|OTHER|||||||0.4686|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.4686
70984944|NCT01751646|141478636|OTHER|||||||0.7601|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.7601
70984945|NCT01751646|141478638|OTHER|||||||0.3978|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.3978
70984946|NCT01751646|141478640|OTHER|||||||0.1187|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.1187
70984947|NCT01751646|141478643|OTHER|||||||0.5098|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.5098
70984948|NCT01751646|141478644|OTHER|||||||0.255|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.2550
70984949|NCT01751646|141478645|OTHER|||||||0.6499|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.6499
70984950|NCT01751646|141478646|OTHER|||||||0.2348|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.2348
70984951|NCT01751646|141478649|OTHER|||||||0.2648|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.2648
70984952|NCT01751646|141478652|OTHER|||||||0.3728|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.3728
70984953|NCT01751646|141478655|OTHER|||||||0.7825|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.7825
70984954|NCT01751646|141478658|OTHER|||||||0.195|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.1950
71097766|NCT01227395|141703980|SUPERIORITY_OR_OTHER||||||=|0.334|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between Male and Female  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=0.334
71097767|NCT01227395|141703981|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was concomitant drugs. The null hypothesis is there is no difference between with and without concomitant drugs  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=1.000
70984955|NCT01751646|141478661|OTHER|||||||0.7127|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.7127
70984956|NCT01751646|141478664|OTHER|||||||0.4676|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.4676
70984957|NCT01751646|141478667|OTHER|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.0210
71097768|NCT01227395|141703982|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without renal dysfunction  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=1.000
70984958|NCT01751646|141478670|OTHER|||||||0.0144|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.0144
70984959|NCT01751646|141478673|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||< 0.0001
70984960|NCT01751646|141478676|OTHER|||||||0.0814|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.0814
70984961|NCT01751646|141478679|OTHER|||||||0.4808|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.4808
70984962|NCT01751646|141478682|OTHER|||||||0.387|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.3870
70984963|NCT01751646|141478685|OTHER|||||||0.429|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.4290
70984964|NCT01751646|141478686|OTHER|||||||0.9186|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.9186
70984965|NCT01751646|141478687|OTHER|||||||0.4016|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.4016
71097769|NCT01227395|141703983|SUPERIORITY_OR_OTHER||||||=|0.015|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Allergies. The null hypothesis is there is no difference between with and without allergies in the frequency of Treatment Related Adverse Events(TRAEs)."||||=0.015
70984966|NCT01751646|141478688|OTHER|||||||0.581|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.5810
70984967|NCT01751646|141478689|OTHER|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.1570
70984968|NCT01751646|141478695|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Test of change from baseline to week 48||||<0.0001
70984969|NCT01751646|141478695|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Test of change from baseline to Week 48||||<0.0001
70984970|NCT01751646|141478698|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Test of Week 48 difference from baseline||||< 0.0001
70984971|NCT01751646|141478698|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Test of Week 48 difference from baseline||||< 0.0001
70984972|NCT02973815|141478703|OTHER||Mean Difference (Final Values)|-0.062|STANDARD_ERROR_OF_MEAN|0.065||0.342|TWO_SIDED|95.0|-0.194|0.067|||Regression, Linear|||This was adjusted for the baseline BMI-Z score, child sex, baseline child age, and economic assistance||0.067|-0.194|0.342
70984973|NCT02973815|141478704|OTHER||Mean Difference (Net)|1.25|STANDARD_ERROR_OF_MEAN|0.73104||0.09|TWO_SIDED|95.0|-0.2|2.71|||Regression, Linear|||Adjusted for: baseline HFI Fruit value, and economic assistance status||2.71|-0.20|0.09
70984974|NCT02973815|141478705|OTHER||Mean Difference (Net)|1.23|STANDARD_ERROR_OF_MEAN|0.61||0.047|TWO_SIDED|95.0|0.02|2.44|||Regression, Linear|||Adjusted for: baseline HFI Vegetable value, and economic assistance status||2.44|0.02|0.047
70984975|NCT02973815|141478706|OTHER||Mean Difference (Net)|0.48|STANDARD_ERROR_OF_MEAN|0.2||0.019|TWO_SIDED|95.0|0.08|0.88|||Regression, Linear|||Adjusted for: baseline healthfulness score and economic assistance status||0.88|0.08|0.019
70984976|NCT02973815|141478707|OTHER||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.12||0.218|TWO_SIDED|95.0|-0.4|0.09|||Regression, Linear|||Adjusted for: baseline vegetable intake, child age (baseline), parent education status (bachelors or higher vs lower)||0.09|-0.4|0.218
70984977|NCT02973815|141478708|OTHER||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|0.2||0.066|TWO_SIDED|95.0|-0.03|0.77|||Regression, Linear|||Adjusted for: baseline fruit intake, child age (baseline), parent education status (bachelors or higher vs lower)||0.77|-0.03|0.066
70984978|NCT02973815|141478709|OTHER||Mean Difference (Net)|-4.79|STANDARD_ERROR_OF_MEAN|4.41||0.28|TWO_SIDED|95.0|-13.56|3.98|||Regression, Linear|||Adjusted for: baseline MVPA, child age (baseline), and child sex||3.98|-13.56|0.28
70984979|NCT02973815|141478710|OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.17||0.928|TWO_SIDED|95.0|-0.31|0.34|||Regression, Linear|||Adjusted for: baseline screentime, child age (baseline), and child sex||0.34|-0.31|0.928
70984980|NCT02613572|141478711|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
70984981|NCT02613572|141478712|SUPERIORITY|||||||0.009|||||||Mixed Models Analysis|||||||0.009
70984982|NCT02613572|141478713|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
71037539|NCT02554877|141582188|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-2.22|STANDARD_ERROR_OF_MEAN|3.27||0.4979|TWO_SIDED|90.0|-7.63|3.19||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||3.19|-7.63|0.4979
70984983|NCT02613572|141478714|SUPERIORITY|||||||0.3|||||||Mixed Models Analysis|||||||0.30
70984984|NCT02613572|141478715|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|||||||0.14
70984985|NCT02613572|141478716|SUPERIORITY|||||||0.69|||||||Mixed Models Analysis|||||||0.69
70984986|NCT02342561|141478722|SUPERIORITY_OR_OTHER|||||||0.601|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||At end of surgery||||0.601
70984987|NCT02342561|141478722|SUPERIORITY_OR_OTHER|||||||0.823|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||After skin disinfection||||0.823
70984988|NCT02342561|141478723|SUPERIORITY_OR_OTHER|||||||0.731|TWO_SIDED||||||Fisher Exact|||Difference in prevalence of CoNs between the 2 groups was analysed. The null-hypothesis was no difference.||||0.731
70984989|NCT02218203|141478750|OTHER|We report the interaction between the lidocaine dose response and dextromethorphan dose response. The type of statistical test was a linear regression model with Chi-square test.|Lidocaine dose*dextromethorphan dose|0.0042|STANDARD_ERROR_OF_MEAN|0.002||0.0322|TWO_SIDED|95.0|0.0004|0.0081|||Pearson's Chi-squared test||The estimated value is an estimated interaction term, and not a P-value.|We performed a lidocaine dose response clinical trial nested within a dextromethorphan clinical trial to evaluate a potential interaction between lidocaine dose and dextromethorphan dose (pain intensity; Gracely scale).||0.0081|0.0004|0.0322
70984990|NCT00465738|141478751|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% Newcombe-Wilson confidence interval for the difference between the response rates of the groups was calculated. The lower bound of the Newcombe-Wilson CI for the difference of proportions was compared to the non-inferiority margin of -25%.|difference in response rates|10.6|||||TWO_SIDED|95.0|-4.4|24.9|||||difference in response rates = response rate for high volume dilution group (20 U/ml) - response rate for low volume dilution group (50 U/ml)|Null hypothesis: The response rate for the low volume dilution group (50 U/ml) is greater than the response rate for the high volume dilution group (20 U/ml).||24.9|-4.4|
70984991|NCT03425656|141478813|NON_INFERIORITY|We used a non-inferiority margin of 0.25 for the primary endpoint.|Mean Difference (Net)|-0.03||||0.73|TWO_SIDED|95.0|-0.23|0.16|||Chi-squared|||||0.16|-0.23|0.73
70984992|NCT03425656|141478814|OTHER|||||||0.72|||||||Fisher Exact|||||||0.72
70984993|NCT03425656|141478815|OTHER||Chi-squared|0.42||||0.42|TWO_SIDED||||||Chi-squared|||||||0.42
70984994|NCT03425656|141478816|NON_INFERIORITY|We used a non-inferiority margin of 0.25 for the primary endpoint.||||||0.59|||||||Chi-squared|||||||0.59
70984995|NCT03461965|141478818|OTHER|p-value \< 0.05 was considered statistically significant||||||0.007|||||||t-test, 2 sided|||Comparing total responses that were correct across all participants in both arms||||0.007
70984996|NCT03461965|141478819|OTHER|p-value \< 0.05 was considered statistically significant||||||0.0001|||||||t-test, 2 sided|||Difference of pre (baseline) and post-test scores within each treatment group||||0.0001
70984997|NCT03461965|141478819|OTHER|p-value \< 0.05 was considered statistically significant|||||<|0.03|||||||t-test, 2 sided|||Difference of pre (baseline) and post-test scores within each treatment group||||<0.03
70984998|NCT03461965|141478819|OTHER|p-value \< 0.05 was considered statistically significant||||||0.352|||||||t-test, 2 sided|paired t-test||Comparing change in scores (post-stage minus baseline) between experimental and control groups||||0.352
70984999|NCT03461965|141478820|OTHER|p-value \< 0.05 was considered statistically significant|||||<|0.0001|||||||t-test, 2 sided|||Difference of pre (baseline) and post-test scores within each treatment group||||<0.0001
70985000|NCT03461965|141478820|OTHER|p-value \< 0.05 was considered statistically significant||||||0.04|||||||t-test, 2 sided|||Difference of pre (baseline) and post-test scores within each treatment group||||0.04
70985001|NCT03461965|141478820|OTHER|p-value \< 0.05 was considered statistically significant||||||0.052|||||||t-test, 2 sided|paired t-test||Comparing change in scores (post-stage minus baseline) between experimental and control groups||||0.052
70985002|NCT03461965|141478821|OTHER|p-value \< 0.05 was considered statistically significant|||||<|0.0001|||||||t-test, 2 sided|||Difference of pre (baseline) and post-test scores within each treatment group||||<0.0001
70985003|NCT03461965|141478821|OTHER|p-value \< 0.05 was considered statistically significant|||||<|0.0001|||||||t-test, 2 sided|||Difference of pre (baseline) and post-test scores within each treatment group||||<0.0001
70985004|NCT03461965|141478821|OTHER|p-value \< 0.05 was considered statistically significant||||||0.208|||||||t-test, 2 sided|paired t-test||Comparing change in scores (post-stage minus baseline) between experimental and control groups||||0.208
70985005|NCT03461965|141478822|OTHER|p-value \< 0.05 was considered statistically significant|||||<|0.03|||||||Chi-squared|||||||<0.03
70985006|NCT01863758|141478823|SUPERIORITY_OR_OTHER||Annualized number of bleeding episodes|3.13|||<|0.05|TWO_SIDED|95.0|2.56|3.8|||2-sided, 1-sample Poisson test||The annualized number of bleeding episodes in study GENA-01 was 49.36.|This study was considered as showing efficacy if the annualized number of bleeding episodes (BE) was reduced by 50% compared to the number of BEs observed in study GENA-01 (NCT00989196).||3.80|2.56|<0.05
70985007|NCT01863758|141478824|SUPERIORITY_OR_OTHER||Annualized number of spontaneous BEs|1.9|||<|0.05|TWO_SIDED|95.0|1.46|2.43|||2-sided, 1-sample Poisson test||The annualized number of spontaneous bleeding episodes in study GENA-01 was 32.23|This study was considered as showing efficacy if the annualized number of spontaneous bleeding episodes (BE) was reduced by 50% compared to the number of spontaneous BEs observed in study GENA-01 (NCT00989196).||2.43|1.46|<0.05
70985008|NCT04192448|141478917|OTHER|Target sample size was 200 participants. Power calculation was determined using nQuery version 8.4.1 for the 2x2 design, using 50 subject per group (including a conservative 10% dropout). Power calculation estimated 80% power to detect an effect size of 0.3 in both factors with no interaction, and greater power if there is an interaction effect. Current enrollment indicates study is underpowered. Because there are not enough participants to conduct an ANOVA or ANCOVA, t-tests were conducted.|Mean Difference (Final Values)|1.82||||0.28|TWO_SIDED|95.0|-29.82|26.19|||t-test, 1 sided|This t-test examined the difference in sexual aggression intentions between those in the Alcohol condition and those in the Sober condition.|The estimation parameter refers to the mean difference in the outcome between those in the Alcohol condition and those in the Sober condition. A positive value indicates greater likelihood of sexual aggression among those in the Alcohol condition.|The number of participants enrolled in the study constrained the type of statistical analyses able to be conducted. Indeed, the Sober x Anger condition could not be compared to the other arms because no participants were randomly assigned to that arm.||26.19|-29.82|.28
71097770|NCT01227395|141703984|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=1.000
71097771|NCT01227395|141703985|SUPERIORITY_OR_OTHER||||||=|0.29|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between Male and Female  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=0.290
70985009|NCT04192448|141478917|OTHER|Target sample size was 200 participants. Power calculation was determined using nQuery version 8.4.1 for the 2x2 design, using 50 subject per group (including a conservative 10% dropout). Power calculation estimated 80% power to detect an effect size of 0.3 in both factors with no interaction, and greater power if there is an interaction effect. Current enrollment indicates study is underpowered. Because there are not enough participants to conduct an ANOVA or ANCOVA, t-tests were conducted.|Mean Difference (Final Values)|-1.0||||0.39|TWO_SIDED|95.0|-33.01|35.01|||t-test, 1 sided|This t-test examined the difference in sexual aggression intentions between those in the Anger condition and those in the Control condition.|The estimation parameter refers to the mean difference in the outcome between those in the Anger condition and those in the Control condition. A negative value indicates greater likelihood of sexual aggression among those in the Control condition.|The number of participants enrolled in the study constrained the type of statistical analyses able to be conducted. Indeed, the Sober x Anger condition could not be compared to the other arms because no participants were randomly assigned to that arm.||35.01|-33.01|.39
71008795|NCT02055976|141525255|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.20298|STANDARD_ERROR_OF_MEAN|0.14142|<|0.001|TWO_SIDED|95.0|-2.48399|-1.92197|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.92197|-2.48399|<0.001
71008796|NCT02055976|141525256|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-41.92915|STANDARD_ERROR_OF_MEAN|2.83037|<|0.001|TWO_SIDED|95.0|-47.55052|-36.30778|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-36.30778|-47.55052|<0.001
71097772|NCT01227395|141703986|SUPERIORITY_OR_OTHER||||||=|0.003|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without renal dysfunction  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=0.003
71097773|NCT01227395|141703987|SUPERIORITY_OR_OTHER||||||=|0.707|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Allergies. The null hypothesis is there is no difference between with and without allergies in the frequency of Treatment Related Adverse Events(TRAEs)."||||=0.707
71097774|NCT01398475|141703990|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|1.02|||||TWO_SIDED|90.0|0.951|1.1|||||The geometric LS mean ratio (TF1 fasted divided by RF fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.|||1.10|0.951|
70985010|NCT04192448|141478918|OTHER|Target sample size was 200 participants. Power calculation was determined using nQuery version 8.4.1 for the 2x2 design, using 50 subject per group (including a conservative 10% dropout). Power calculation estimated 80% power to detect an effect size of 0.3 in both factors with no interaction, and greater power if there is an interaction effect. Current enrollment indicates study is underpowered. Because there are not enough participants to conduct an ANOVA or ANCOVA, t-tests were conducted.|Mean Difference (Final Values)|0.25||||0.33|TWO_SIDED|95.0|-2.88|2.63|||t-test, 1 sided|This t-test examined the difference in physical aggression intentions between those in the Alcohol Condition and those in the Sober condition.|The estimation parameter refers to the mean difference in the outcome between those in the Alcohol condition and those in the Sober condition. A positive value indicates greater likelihood of physical aggression among those in the Alcohol condition.|The number of participants enrolled in the study constrained the type of statistical analyses able to be conducted. Indeed, the Sober x Anger condition could not be compared to the other arms because no participants were randomly assigned to that arm.||2.63|-2.88|.33
70985011|NCT04192448|141478918|OTHER|Target sample size was 200 participants. Power calculation was determined using nQuery version 8.4.1 for the 2x2 design, using 50 subject per group (including a conservative 10% dropout). Power calculation estimated 80% power to detect an effect size of 0.3 in both factors with no interaction, and greater power if there is an interaction effect. Current enrollment indicates study is underpowered. Because there are not enough participants to conduct an ANOVA or ANCOVA, t-tests were conducted.|Mean Difference (Final Values)|-0.25||||0.33|TWO_SIDED|95.0|-2.53|2.88|||t-test, 1 sided|The t-test examined the difference in physical aggression intentions between those in the Anger condition and those in the Control condition.|The estimation parameter refers to the mean difference in the outcome between those in the Anger condition and those in the Control condition. A negative value indicates greater likelihood of physical aggression among those in the Control condition.|The number of participants enrolled in the study constrained the type of statistical analyses able to be conducted. Indeed, the Sober x Anger condition could not be compared to the other arms because no participants were randomly assigned to that arm.||2.88|-2.53|.33
70985012|NCT04192448|141478919|OTHER|Target sample size was 200 participants. Power calculation was determined using nQuery version 8.4.1 for the 2x2 design, using 50 subject per group (including a conservative 10% dropout). Power calculation estimated 80% power to detect an effect size of 0.3 in both factors with no interaction, and greater power if there is an interaction effect. Current enrollment indicates study is underpowered. Because there are not enough participants to conduct an ANOVA or ANCOVA, t-tests were conducted.|Mean Difference (Final Values)|0.67||||0.23|TWO_SIDED|95.0|-8.0|6.67|||t-test, 1 sided|The t-test examined differences in psychological aggression intentions between those in the Alcohol condition and those in the Sober condition.|The estimation parameter refers to the mean difference in the outcome between those in the Alcohol condition and those in the Sober condition. A positive value indicates greater likelihood of psych aggression among those in the Alcohol condition.|The number of participants enrolled in the study constrained the type of statistical analyses able to be conducted. Indeed, the Sober x Anger condition could not be compared to the other arms because no participants were randomly assigned to that arm.||6.67|-8.00|.23
71037540|NCT02554877|141582188|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-3.45|STANDARD_ERROR_OF_MEAN|3.27||0.2927|TWO_SIDED|90.0|-8.85|1.95||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||1.95|-8.85|0.2927
71037541|NCT02554877|141582188|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-4.83|STANDARD_ERROR_OF_MEAN|3.28||0.143|TWO_SIDED|90.0|-10.26|0.6||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||0.60|-10.26|0.1430
71037542|NCT02554877|141582188|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.25|STANDARD_ERROR_OF_MEAN|3.73||0.7373|TWO_SIDED|90.0|-7.42|4.92||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||4.92|-7.42|0.7373
71097775|NCT01398475|141703990|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|1.02|||||TWO_SIDED|90.0|0.947|1.09|||||The geometric LS mean ratio (TF2 fasted divided by RF fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.|||1.09|0.947|
71097776|NCT01398475|141703990|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.888|||||TWO_SIDED|90.0|0.827|0.953|||||The geometric LS mean ratio (TF2 fed divided by TF2 fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.|||0.953|0.827|
71097777|NCT01398475|141703991|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|0.979|||||TWO_SIDED|90.0|0.868|1.1|||||The geometric LS mean ratio (TF1 fasted divided by RF fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.|||1.10|0.868|
71097778|NCT01398475|141703991|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.962|||||TWO_SIDED|90.0|0.852|1.08|||||The geometric LS mean ratio (TF2 fasted divided by RF fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.|||1.08|0.852|
71097779|NCT01398475|141703991|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.82|||||TWO_SIDED|90.0|0.727|0.925|||||The geometric LS mean ratio (TF2 fed divided by TF2 fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.|||0.925|0.727|
71097780|NCT01398475|141703992|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.719|TWO_SIDED|90.0|-0.25|0.5|||Wilcoxon (Mann-Whitney)||The median difference was calculated as TF1 fasted minus RF fasted.|||0.500|-0.250|0.719
70985013|NCT04192448|141478919|OTHER|Target sample size was 200 participants. Power calculation was determined using nQuery version 8.4.1 for the 2x2 design, using 50 subject per group (including a conservative 10% dropout). Power calculation estimated 80% power to detect an effect size of 0.3 in both factors with no interaction, and greater power if there is an interaction effect. Current enrollment indicates study is underpowered. Because there are not enough participants to conduct an ANOVA or ANCOVA, t-tests were conducted.|Mean Difference (Final Values)|-0.17||||0.44|TWO_SIDED|95.0|-10.84|11.17|||t-test, 1 sided|The t-test examined the difference in psychological aggression intentions between those in the Anger condition and those in the Control condition.|The estimation parameter refers to the mean difference in the outcome between those in the Alcohol condition and those in the Sober condition. A negative value indicates greater likelihood of psych aggression among those in the Control condition.|The number of participants enrolled in the study constrained the type of statistical analyses able to be conducted. Indeed, the Sober x Anger condition could not be compared to the other arms because no participants were randomly assigned to that arm.||11.17|-10.84|.44
70985014|NCT01269125|141478926|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.28|STANDARD_ERROR_OF_MEAN|0.0||0.8|TWO_SIDED|95.0|-0.2|0.3|||Chi-squared|||||0.3|-0.2|0.80
70985015|NCT01269125|141478930|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.05|STANDARD_ERROR_OF_MEAN|0.0||0.8||95.0|-0.2|0.3|||Chi-squared|||||0.3|-0.2|0.80
70985016|NCT01269125|141478930|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.48||95.0|-0.4|0.2|||Chi-squared|||In order to handle the problem of small sample size combined with the inability to identify the theoretical statistical distribution of data, bootstrap techniques are used (10). Ader and co-workers recommend the bootstrap procedure when (a) the theoretical distribution is complicated or unknown, and/or (b) power calculations have to be performed and a small sample is available (11). Finally, the bootstrap distribution has been used in order to calculate all the confidence intervals.||0.2|-0.4|0.48
70985017|NCT01269125|141478930|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|-0.15|STANDARD_ERROR_OF_MEAN|0.0||0.22||95.0|-0.4|0.1|||Chi-squared|||In order to handle the problem of small sample size combined with the inability to identify the theoretical statistical distribution of data, bootstrap techniques are used (10). Ader and co-workers recommend the bootstrap procedure when (a) the theoretical distribution is complicated or unknown, and/or (b) power calculations have to be performed and a small sample is available (11). Finally, the bootstrap distribution has been used in order to calculate all the confidence intervals.||0.1|-0.4|0.22
70985018|NCT02773758|141478955|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.509|-1.071|||ANCOVA|From ANCOVA model with change from baseline in Schiff Sensitivity Score as response and treatment and baseline Schiff sensitivity score as covariates.|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|||-1.071|-1.509|<0.0001
70985019|NCT03952546|141479011|NON_INFERIORITY|The test for non-inferiority was carried out by calculating the upper 95% confidence limit (one sided confidence interval) for the difference in estimated blood loss (δ = Unipolar electrocautery system - Saline-coupled bipolar sealer), with the margin of inferiority (δ), set at 200 cc.||||||0.1254|||||||t-test, 1 sided|||||||0.1254
70985020|NCT03952546|141479012|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70985021|NCT01371838|141479017|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the observed difference in the primary outcome measure (clinical cure rate) between the ceftaroline group and the ceftriaxone group was calculated in CE Population at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10% in CE Population. If non-inferioirity was achieved then a test of superioirty was conducted whereby if lower limit of 95% CI for the difference was \>0% superioirty was concluded.|Risk Difference (RD)|9.9|||||TWO_SIDED|95.0|2.8|17.1||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared to that for ceftriaxone at TOC in the CE in adult subjects with CABP.||17.1|2.8|
70985022|NCT01371838|141479018|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.7|||||TWO_SIDED|95.0|4.9|16.4||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||16.4|4.9|
71037543|NCT02554877|141582188|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-2.46|STANDARD_ERROR_OF_MEAN|3.7||0.5075|TWO_SIDED|90.0|-8.57|3.66||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||3.66|-8.57|0.5075
71037544|NCT02554877|141582188|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.81|STANDARD_ERROR_OF_MEAN|3.74||0.6295|TWO_SIDED|90.0|-7.99|4.37||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||4.37|-7.99|0.6295
71037545|NCT02554877|141582188|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.15|STANDARD_ERROR_OF_MEAN|3.95||0.4266|TWO_SIDED|90.0|-3.39|9.69||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||9.69|-3.39|0.4266
71037546|NCT02554877|141582188|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|4.96|STANDARD_ERROR_OF_MEAN|3.89||0.2038|TWO_SIDED|90.0|-1.47|11.4||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||11.40|-1.47|0.2038
71037547|NCT02554877|141582188|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|2.29|STANDARD_ERROR_OF_MEAN|3.92||0.5592|TWO_SIDED|90.0|-4.19|8.78||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||8.78|-4.19|0.5592
70985023|NCT01371838|141479019|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.5|||||TWO_SIDED|95.0|1.8|15.4||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||15.4|1.8|
70985024|NCT01371838|141479020|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.0|||||TWO_SIDED|95.0|6.8|19.2||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments. If lower limit of 95% CI for the risk difference was \>0% superioirty was concluded in this population.|||19.2|6.8|
70985025|NCT01371838|141479021|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.2|||||TWO_SIDED|95.0|2.7|27.1||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||27.1|2.7|
70985026|NCT01371838|141479022|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.9|||||TWO_SIDED|95.0|-2.2|25.8||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||25.8|-2.2|
70985027|NCT01371838|141479025|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.2|||||TWO_SIDED|95.0|2.7|27.1||||RD is (Ceftaroline-Ceftriaxone) microbiologically favourable outcome rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||27.1|2.7|
70985028|NCT01371838|141479026|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.9|||||TWO_SIDED|95.0|-2.2|25.8||||RD is (Ceftaroline-Ceftriaxone) microbiologically favourable outcome rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||25.8|-2.2|
70985029|NCT01371838|141479027|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.0|||||TWO_SIDED|95.0|6.8|19.2||||RD is Ceftaroline minus Ceftriaxone overall success rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||19.2|6.8|
70985030|NCT01371838|141479028|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.9|||||TWO_SIDED|95.0|2.8|17.1||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||17.1|2.8|
71097781|NCT01398475|141703992|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.96|TWO_SIDED|90.0|-0.25|0.75|||Wilcoxon (Mann-Whitney)||The median difference was calculated as TF2 fasted minus RF fasted.|||0.750|-0.250|0.960
70985031|NCT01371838|141479029|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-2.5|3.0||||RD is Ceftaroline minus Ceftriaxone No-relapse rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||3.0|-2.5|
70985032|NCT01371838|141479030|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.1|||||TWO_SIDED|95.0|-2.4|4.5||||RD is Ceftaroline minus Ceftriaxone No-relapse rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||4.5|-2.4|
71037548|NCT02554877|141582189|SUPERIORITY_OR_OTHER||Median Difference (Net)|5.09|||||TWO_SIDED|90.0|-5.86|16.05||||||Placebo was the reference and each of the active doses was the test for Week 2.||16.05|-5.86|
71037549|NCT02554877|141582189|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.86|||||TWO_SIDED|90.0|-9.76|15.48||||||Placebo was the reference and each of the active doses was the test for Week 2.||15.48|-9.76|
71037550|NCT02554877|141582189|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.13|||||TWO_SIDED|90.0|3.91|30.34||||||Placebo was the reference and each of the active doses was the test for Week 2.||30.34|3.91|
71037551|NCT02554877|141582189|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.71|||||TWO_SIDED|90.0|-10.8|16.22||||||Placebo was the reference and each of the active doses was the test for Week 4.||16.22|-10.80|
71037552|NCT02554877|141582189|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.92|||||TWO_SIDED|90.0|-10.61|16.45||||||Placebo was the reference and each of the active doses was the test for Week 4.||16.45|-10.61|
71037553|NCT02554877|141582189|SUPERIORITY_OR_OTHER||Median Difference (Net)|-2.57|||||TWO_SIDED|90.0|-15.08|9.94||||||Placebo was the reference and each of the active doses was the test for Week 4.||9.94|-15.08|
71037554|NCT02554877|141582189|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.63|||||TWO_SIDED|90.0|-16.29|13.03||||||Placebo was the reference and each of the active doses was the test for Week 8.||13.03|-16.29|
71037555|NCT02554877|141582189|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.59|||||TWO_SIDED|90.0|-20.4|11.22||||||Placebo was the reference and each of the active doses was the test for Week 8.||11.22|-20.40|
71037556|NCT02554877|141582189|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.75|||||TWO_SIDED|90.0|-13.66|19.16||||||Placebo was the reference and each of the active doses was the test for Week 8.||19.16|-13.66|
71037557|NCT02554877|141582189|SUPERIORITY_OR_OTHER||Median Difference (Net)|7.86|||||TWO_SIDED|90.0|-3.3|19.02||||||Placebo was the reference and each of the active doses was the test for Week 12.||19.02|-3.30|
71037558|NCT02554877|141582189|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.13|||||TWO_SIDED|90.0|-16.13|13.87||||||Placebo was the reference and each of the active doses was the test for Week 12.||13.87|-16.13|
71037559|NCT02554877|141582189|SUPERIORITY_OR_OTHER||Median Difference (Net)|5.99|||||TWO_SIDED|90.0|-7.07|19.04||||||Placebo was the reference and each of the active doses was the test for Week 12.||19.04|-7.07|
71037560|NCT02554877|141582190|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.04|STANDARD_ERROR_OF_MEAN|2.52||0.68|TWO_SIDED|90.0|-3.12|5.2||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||5.20|-3.12|0.6800
71037561|NCT02554877|141582190|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.64|STANDARD_ERROR_OF_MEAN|2.52||0.515|TWO_SIDED|90.0|-2.52|5.8||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||5.80|-2.52|0.5150
70985033|NCT01334125|141479033|SUPERIORITY_OR_OTHER|||||||0.903|TWO_SIDED|||||Individual two-way mixed ANOVA models were fitted for each of our outcomes of interest, with treatment type (metformin or placebo) as the fixed effect, and baseline values, age, gender, and BMI as covariates.|ANOVA|||Analyses were based on the intent-to-treat principle and were performed using SPSS v.22 (IBM Corporation, Armonk, NY).||||0.903
70985034|NCT01334125|141479034|SUPERIORITY_OR_OTHER|||||||0.578|TWO_SIDED|95.0||||Individual two-way mixed ANOVA models were fitted for each of our outcomes of interest, with treatment type (metformin or placebo) as the fixed effect, and baseline values, age, gender, and BMI as covariates.|ANOVA|||Analyses were based on the intent-to-treat principle and were performed using SPSS v.22 (IBM Corporation, Armonk, NY).||||0.578
70985035|NCT01334125|141479035|SUPERIORITY_OR_OTHER|||||||0.057|||||||ANOVA|||Two way ANOVA comparison of the means of the adiponectin/leptin ratios between the metformin and placebo groups||||0.057
70985036|NCT01334125|141479036|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||p value represents the analysis for minor hypoglycemia||||1.00
70985037|NCT01334125|141479036|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||p value represents the analysis of the nocturnal hypoglycemia||||1.00
70985038|NCT00641043|141479041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.71|-0.3|||ANCOVA|||Linagliptin vs. Placebo||-0.30|-0.71|<0.0001
70985039|NCT00641043|141479042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|-0.52|-0.24|||ANCOVA|||Linagliptin vs. Placebo||-0.24|-0.52|<0.0001
70985040|NCT00641043|141479043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.67|-0.32|||ANCOVA|||Linagliptin vs. Placebo||-0.32|-0.67|<0.0001
70985041|NCT00641043|141479044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.7|-0.32|||ANCOVA|||Linagliptin vs. Placebo||-0.32|-0.70|<0.0001
70985042|NCT00641043|141479045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.2|STANDARD_ERROR_OF_MEAN|3.5|<|0.0001||95.0|-21.1|-7.3|||ANCOVA|||Linagliptin vs. Placebo||-7.3|-21.1|<0.0001
70985043|NCT00641043|141479046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.4|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001||95.0|-22.3|-10.5|||ANCOVA|||Linagliptin vs. Placebo||-10.5|-22.3|<0.0001
70985044|NCT00641043|141479047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.2|STANDARD_ERROR_OF_MEAN|3.2|<|0.0001||95.0|-19.5|-7.0|||ANCOVA|||Linagliptin vs. Placebo||-7.0|-19.5|<0.0001
70985045|NCT00641043|141479048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.9|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-20.5|-7.3|||ANCOVA|||Linagliptin vs. Placebo||-7.3|-20.5|<0.0001
70985046|NCT00641043|141479049|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.103||||0.0051||95.0|1.25|3.539|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."||3.539|1.25|0.0051
70985047|NCT00641043|141479051|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.348||||0.3547||95.0|0.716|2.537|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."||2.537|0.716|0.3547
70985048|NCT00641043|141479053|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.823|||<|0.0001||95.0|2.286|6.394|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."||6.394|2.286|<0.0001
70985049|NCT03088605|141479102|SUPERIORITY||Mean Difference (Net)|-0.3||||0.02|TWO_SIDED|90.0|-0.7|0.0|||ANCOVA|||Change from Baseline. ANCOVA model includes baseline scores as a covariate||0|-0.7|0.02
70985050|NCT03088605|141479103|SUPERIORITY||Mean Difference (Net)|-1.0||||0.0001|TWO_SIDED|90.0|-1.4|0.5|||ANCOVA|||Change form baseline. ANCOVA model includes baseline score as a covariate.||0.5|-1.4|0.0001
70985051|NCT03088605|141479104|SUPERIORITY||Mean Difference (Net)|-1.42||||0.03|TWO_SIDED|90.0|-2.36|-0.47|||ANCOVA|||Change from baseline. ANCOVA model includes baseline score as a covariate.||-0.47|-2.36|0.03
70985052|NCT03088605|141479105|SUPERIORITY||Mean Difference (Net)|0.199||||0.39|TWO_SIDED|90.0|-0.177|0.575|||ANCOVA|||Change from Baseline; ANCOVA model includes baseline score as a covariate.||0.575|-0.177|0.39
70985053|NCT03088605|141479106|SUPERIORITY||Mean Difference (Net)|0.2||||0.97|TWO_SIDED|90.0|-1.7|2.0|||ANCOVA|||Change from baseline. ANCOVA model includes baseline score as a covariate.||2.0|-1.7|0.97
70985054|NCT03088605|141479107|SUPERIORITY||Mean Difference (Net)|-0.23||||0.06|TWO_SIDED|90.0|-0.48|0.03|||ANCOVA|||Change from baseline. ANCOVA model includes baseline score as a covariate.||0.03|-0.48|0.06
70985055|NCT03136705|141479113|SUPERIORITY||trend analysis|1.009||||0.3738|TWO_SIDED|95.0|0.989|1.031|||Mixed Models Analysis|||linear mixed model for repeated measures data||1.031|0.989|0.3738
70985056|NCT03136705|141479114|SUPERIORITY||trend analysis|0.0043||||0.854|TWO_SIDED|95.0|-0.0414|0.0499|||Mixed Models Analysis|||linear mixed model for repeated measures data||0.0499|-0.0414|0.854
70985057|NCT03136705|141479115|SUPERIORITY||trend analysis|20.38||||0.0648|TWO_SIDED|95.0|-1.26|42.03|||Mixed Models Analysis|||linear mixed model for repeated measures data||42.03|-1.26|0.0648
70985058|NCT02927171|141479130|OTHER|||||||0.17|||||||t-test, 1 sided|||||||0.17
70985059|NCT01720667|141479153|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||Comparison of 24 hour seizure termination rates using a Fisher's exact test.||||<0.001
70985060|NCT01720667|141479154|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||Comparison of seizure cessation at 48 hours using Fisher's exact test||||<0.001
70985061|NCT01221233|141479181|SUPERIORITY||Median Difference (Final Values)|17.6||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.000
70985062|NCT00611455|141479186|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.86|||<|0.001|TWO_SIDED|95.0|1.67|4.91|||Cochran-Mantel-Haenszel|||||4.91|1.67|<0.001
70985063|NCT00858702|141479235|SUPERIORITY_OR_OTHER|||||||0.0158||95.0||||No consideration for multiplicity|Fisher Exact|||||||0.0158
70985064|NCT00858702|141479236|SUPERIORITY_OR_OTHER|||||||0.0566||95.0||||No consideration for multiplicity|Fisher Exact|||||||0.0566
70985065|NCT00858702|141479237|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No consideration for multiplicity|Fisher Exact|||||||<0.001
70985066|NCT04382651|141479260|SUPERIORITY||Mean Difference (Final Values)|0.98|STANDARD_ERROR_OF_MEAN|2.225||0.33|TWO_SIDED|90.0|-2.7|4.7||1-Sided|ANCOVA|||||4.7|-2.7|0.33
70985067|NCT01873742|141479266|OTHER|The BDI's Cronbach's alpha was .93 at start of therapy, and .95 at the end of therapy.|Mean Difference (Final Values)|1.01|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
70985068|NCT01753518|141479297|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.053
70985069|NCT01753518|141479298|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||Chi-squared|||||||0.73
70985070|NCT01753518|141479299|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Fisher Exact|||Comparison for staple expulsion or suture trimming||||0.25
70985071|NCT01753518|141479299|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Fisher Exact|||Comparison for Surgical Site Infection||||0.06
70985072|NCT01753518|141479299|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||Fisher Exact|||Comparison for Superficial Wound Separation||||0.21
70985073|NCT01753518|141479299|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||Fisher Exact|||Comparison for Seroma||||0.49
70985074|NCT01753518|141479299|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Fisher Exact|||Comparison for Hematoma||||0.50
70985075|NCT01753518|141479300|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the arms for Tylenol use.||||0.48
70985076|NCT01753518|141479300|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the arms for Ibuprofen use.||||0.30
70985077|NCT01753518|141479300|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the arms for Toradol use.||||0.85
70985078|NCT01753518|141479300|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the arms for Oxycodone use.||||0.78
70985079|NCT01753518|141479302|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||Fisher Exact|||"Comparison for negative responses to Appearance of incision question."||||0.51
70985080|NCT01753518|141479302|SUPERIORITY_OR_OTHER|||||||0.098|TWO_SIDED||||||Chi-squared|||"Comparison for negative responses to Would recommend treatment to friends question."||||0.098
70985081|NCT01753518|141479302|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Chi-squared|||"Comparison of negative responses to Willingness to use treatment again question."||||0.57
70985082|NCT01753518|141479302|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Fisher Exact|||"Comparison of negative responses to Overall satisfaction question."||||0.41
70985083|NCT01753518|141479303|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED||||||Chi-squared|||"Comparison between arms for appearance of incision."||||0.85
70985084|NCT01753518|141479303|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||Chi-squared|||"Comparison between arms for recommend treatment."||||0.004
70985085|NCT01753518|141479303|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"Comparison between arms for willingness to use treatment again."||||<0.001
70985086|NCT01753518|141479304|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70985087|NCT01753518|141479305|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar painful.||||0.35
70985088|NCT01753518|141479305|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar itching.||||0.48
70985089|NCT01753518|141479305|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar color is different.||||0.034
70985090|NCT01753518|141479305|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar stiffness is different.||||0.041
70985091|NCT01753518|141479305|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar thickness is different.||||0.23
70985092|NCT01753518|141479305|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar more irregular.||||0.13
70985093|NCT01753518|141479305|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: overall opinion.||||0.11
70985094|NCT01753518|141479305|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: vascularity.||||0.68
70985095|NCT01753518|141479305|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: pigmentation.||||0.18
70985096|NCT01753518|141479305|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: thickness||||0.75
70985097|NCT01753518|141479305|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: relief.||||0.36
70985098|NCT01753518|141479305|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: pliability.||||0.78
70985099|NCT01753518|141479305|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: surface area.||||0.76
70985100|NCT01753518|141479305|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: overall opinion.||||0.97
70985101|NCT02075255|141479318|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|33.3|||<|0.001|TWO_SIDED|95.0|16.7|50.0|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimate is used.|||50.00|16.70|<0.001
70985102|NCT02075255|141479318|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|37.5|||<|0.001|TWO_SIDED|95.0|20.8|50.0|||Wilcoxon (Mann-Whitney)||Hodges Lehmann estimate is used.|||50.00|20.80|<0.001
70985103|NCT02075255|141479319|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.09|||<|0.001|TWO_SIDED|95.0|2.22|7.57|||proportional odds model|Controlling for treatment group, region, and baseline OCS dose.||||7.57|2.22|<0.001
70985104|NCT02075255|141479319|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.12|||<|0.001|TWO_SIDED|95.0|2.22|7.63|||proportional odds model|Controlling for treatment group, region, and baseline OCS dose.||||7.63|2.22|<0.001
70985105|NCT02075255|141479320|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|50.0|||<|0.001|TWO_SIDED|95.0|25.0|66.7|||Wilcoxon (Mann-Whitney)||Hodges Lehmann estimate is used.|||66.70|25.00|<0.001
70985106|NCT02075255|141479320|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|50.0|||<|0.001|TWO_SIDED|95.0|25.0|66.7|||Wilcoxon (Mann-Whitney)||Hodges Lehmann estimate is used.|||66.70|25.00|<0.001
70985107|NCT02075255|141479321|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.59|||<|0.001|TWO_SIDED|95.0|1.79|7.22|||Cochran-Mantel-Haenszel|Controlling for region.||||7.22|1.79|<0.001
71037562|NCT02554877|141582190|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|4.66|STANDARD_ERROR_OF_MEAN|2.53||0.0676|TWO_SIDED|90.0|0.47|8.85||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||8.85|0.47|0.0676
71037563|NCT02554877|141582190|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.62|STANDARD_ERROR_OF_MEAN|2.48||0.8021|TWO_SIDED|90.0|-4.73|3.48||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||3.48|-4.73|0.8021
71097782|NCT01398475|141703992|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.5||||0.006|TWO_SIDED|90.0|0.0|2.0|||Wilcoxon (Mann-Whitney)||The median difference was calculated as TF2 fed minus TF2 fasted.|||2.00|0|0.006
70985108|NCT02075255|141479321|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.001|TWO_SIDED|95.0|1.57|5.86|||Cochran-Mantel-Haenszel|Controlling for region.||||5.86|1.57|<0.001
70985109|NCT02075255|141479322|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.23|||<|0.001|TWO_SIDED|95.0|1.92|14.21|||Cochran-Mantel-Haenszel|Controlling for region.||||14.21|1.92|<0.001
70985110|NCT02075255|141479322|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.19||||0.002|TWO_SIDED|95.0|1.58|11.12|||Cochran-Mantel-Haenszel|Controlling for region.||||11.12|1.58|0.002
70985111|NCT02075255|141479323|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42||||0.012|TWO_SIDED|95.0|0.21|0.83|||Cochran-Mantel-Haenszel|Controlling for region.||||0.83|0.21|0.012
71097783|NCT00086307|141703997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.826|STANDARD_ERROR_OF_MEAN|2.296||0.018|TWO_SIDED|95.0|1.111|12.541||This is the omnibus effect of drug.|Mixed Models Analysis|||A linear mixed model with restricted maximum likelihood estimation and a first order autoregressive covariance structure was used to examine depressive symptoms over time. Fixed factors for drug, time, and a time by drug interaction were included in the model along with the intercept. No random factors were included because the subject factor did not contribute significantly to the model. Baseline symptoms were used as a covariate.||12.541|1.111|.018
71097784|NCT00086307|141703997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.826|STANDARD_ERROR_OF_MEAN|2.296||0.014|TWO_SIDED|95.0|1.111|12.541||The significance level was adjusted using a Bonferroni correction.|Post hoc simple effects test||The pramipexole group had a lower MADRS score than the pramipexole and escitalopram group.|Post-hoc simple effects tests with Bonferroni correction were used to compare the pramipexole group to the pramipexole and escitalopram combination group.||12.541|1.111|.014
71097785|NCT00086307|141703997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.353|STANDARD_ERROR_OF_MEAN|2.296||0.454|TWO_SIDED|95.0|-2.36|9.066||The significance level was adjusted using a Bonferroni correction.|Post hoc simple effects test||The escitalopram group had a lower MADRS score than the pramipexole and escitalopram group.|Post-hoc simple effects tests with Bonferroni correction were used to compare the escitalopram group to the pramipexole and escitalopram combination group.||9.066|-2.360|.454
70985112|NCT02075255|141479323|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52||||0.053|TWO_SIDED|95.0|0.27|1.01|||Cochran-Mantel-Haenszel|Controlling for region.||||1.01|0.27|0.053
70985113|NCT02075255|141479324|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.16|||<|0.001|TWO_SIDED|95.0|1.6|6.23|||Cochran-Mantel-Haenszel|Controlling for region.||||6.23|1.60|<0.001
70985114|NCT02075255|141479324|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.74||||0.002|TWO_SIDED|95.0|1.41|5.31|||Cochran-Mantel-Haenszel|Controlling for region.||||5.31|1.41|0.002
70985115|NCT02075255|141479325|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32||||0.001|TWO_SIDED|95.0|0.16|0.65|||Cochran-Mantel-Haenszel|Controlling for region.||||0.65|0.16|0.001
70985116|NCT02075255|141479325|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.28|||<|0.001|TWO_SIDED|95.0|0.14|0.56|||Cochran-Mantel-Haenszel|Controlling for region.||||0.56|0.14|<0.001
71097786|NCT00086307|141703997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.473|STANDARD_ERROR_OF_MEAN|2.162||0.349|TWO_SIDED|95.0|-1.942|8.888||The significance level was adjusted using a Bonferroni correction.|Post hoc simple effects test||The pramipexole group had a lower MADRS score than the escitalopram group.|Post-hoc simple effects tests with Bonferroni correction were used to compare the pramipexole group to the escitalopram group.||8.888|-1.942|.349
71097787|NCT03632720|141704024|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95 percent (%) confidence interval (CI) was greater (\>) -10% for all four serogroups.|Difference in Percentage|0.64|||||TWO_SIDED|95.0|-1.78|3.54||||||Serogroup A||3.54|-1.78|
71097788|NCT03632720|141704024|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for all four serogroups.|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-2.24|2.28||||||Serogroup C||2.28|-2.24|
71097789|NCT03632720|141704024|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for all four serogroups.|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-2.33|2.36||||||Serogroup Y||2.36|-2.33|
71097790|NCT03632720|141704024|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for all four serogroups.|Difference in Percentage|-0.58|||||TWO_SIDED|95.0|-3.22|1.81||||||Serogroup W||1.81|-3.22|
71097791|NCT06868667|141704074|OTHER||Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.11|1.52|||||Hazard ratio was estimated using a Cox Proportional Hazards model stratified by the number of lines of prior therapy, prior bortezomib and revised international staging system (R-ISS) at screening, with a covariate of treatment.|||1.52|0.11|
70985117|NCT02075255|141479326|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39|||<|0.001|TWO_SIDED|95.0|0.22|0.66|||Regression, Cox|Including covariates treatment group, region, number of exacerbations in the previous year.||||0.66|0.22|<0.001
70985118|NCT02075255|141479326|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.32|||<|0.001|TWO_SIDED|95.0|0.17|0.57|||Regression, Cox|Including covariates treatment group, region, number of exacerbations in the previous year.||||0.57|0.17|<0.001
70985119|NCT02075255|141479327|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53||||0.291|TWO_SIDED|95.0|0.14|1.64|||Regression, Cox|Including covariates treatment group, region, any exacerbations in the previous year requiring hospitalization or ER visit.||||1.64|0.14|0.291
70985120|NCT02075255|141479327|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.12||||0.042|TWO_SIDED|95.0|0.01|0.63|||Regression, Cox|Including covariates treatment group, region, any exacerbations in the previous year requiring hospitalization or ER visit.||||0.63|0.01|0.042
70985121|NCT02075255|141479328|SUPERIORITY_OR_OTHER||Rate ratio|0.45||||0.003|TWO_SIDED|95.0|0.27|0.76|||negative binomial model|Including covariates treatment group, region, number of exacerbations in the previous year. The log of follow-up time is used as offset variable.||||0.76|0.27|0.003
70985122|NCT02075255|141479328|SUPERIORITY_OR_OTHER||Rate ratio|0.3|||<|0.001|TWO_SIDED|95.0|0.17|0.53|||negative binomial model|Including covariates treatment group, region, number of exacerbations in the previous year. The log of follow-up time is used as offset variable.||||0.53|0.17|<0.001
70985123|NCT02075255|141479329|SUPERIORITY_OR_OTHER||Rate ratio|0.44||||0.187|TWO_SIDED|95.0|0.13|1.49|||negative binomial model|Covariates include treatment, region, any exacerbations in the previous year requiring hospitalization/ER. Log of follow-up time is the offset.||||1.49|0.13|0.187
70985124|NCT02075255|141479329|SUPERIORITY_OR_OTHER||Rate ratio|0.07||||0.018|TWO_SIDED|95.0|0.01|0.63|||negative binomial model|Covariates include treatment, region, any exacerbations in the previous year requiring hospitalization/ER. Log of follow-up time is the offset.||||0.63|0.01|0.018
70985125|NCT02075255|141479331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105||||0.153|TWO_SIDED|95.0|-0.04|0.251|||Mixed Models Analysis|Including covariates: treatment group, region, baseline pre-BD FEV1 value, visit, and visit by treatment interaction.||||0.251|-0.040|0.153
70985126|NCT02075255|141479331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112||||0.129|TWO_SIDED|95.0|-0.033|0.258|||Mixed Models Analysis|Including covariates: treatment group, region, baseline pre-BD FEV1 value, visit, and visit by treatment interaction.||||0.258|-0.033|0.129
70985127|NCT02075255|141479332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.947|TWO_SIDED|95.0|-0.35|0.32|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.||||0.32|-0.35|0.947
70985128|NCT02075255|141479332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.291|TWO_SIDED|95.0|-0.51|0.16|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.||||0.16|-0.51|0.291
70985129|NCT02075255|141479333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.998|TWO_SIDED|95.0|-0.18|0.18|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.||||0.18|-0.18|0.998
70985130|NCT02075255|141479333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.177|TWO_SIDED|95.0|-0.3|0.05|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.||||0.05|-0.30|0.177
70985131|NCT02075255|141479334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.973|TWO_SIDED|95.0|-0.17|0.17|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.||||0.17|-0.17|0.973
70985132|NCT02075255|141479334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.48|TWO_SIDED|95.0|-0.23|0.11|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.||||0.11|-0.23|0.480
70985133|NCT02075255|141479335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.397|TWO_SIDED|95.0|-1.44|0.57|||Mixed Models Analysis|Include covariates: treatment group, baseline total asthma rescue medication use, region, visit, and treatment by visit interaction.||||0.57|-1.44|0.397
70985134|NCT02075255|141479335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.41||||0.006|TWO_SIDED|95.0|-2.42|-0.41|||Mixed Models Analysis|Include covariates: treatment group, baseline total asthma rescue medication use, region, visit, and treatment by visit interaction.||||-0.41|-2.42|0.006
70985135|NCT02075255|141479336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.25||||0.143|TWO_SIDED|95.0|-6.58|45.07|||Mixed Models Analysis|Include covariates: treatment group, baseline morning PEF, region, visit, and treatment by visit interaction.||||45.07|-6.58|0.143
71037564|NCT02554877|141582190|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.95|STANDARD_ERROR_OF_MEAN|2.49||0.4346|TWO_SIDED|90.0|-6.06|2.16||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||2.16|-6.06|0.4346
71097792|NCT05330429|141704100|SUPERIORITY||Hazard Ratio (HR)|0.956||||0.9323|TWO_SIDED|95.0|0.339|2.691|||Unstratified Log-rank Test|2-Sided P-value was based on unstratified log-rank test.|Hazard ratio and its 95% CI were calculated using unstratified Cox proportional hazards regression model.|||2.691|0.339|0.9323
70985136|NCT02075255|141479336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.01||||0.023|TWO_SIDED|95.0|4.26|55.76|||Mixed Models Analysis|Include covariates: treatment group, baseline morning PEF, region, visit, and treatment by visit interaction.||||55.76|4.26|0.023
70985137|NCT02075255|141479337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.19||||0.237|TWO_SIDED|95.0|-10.08|40.46|||Mixed Models Analysis|Include covariates: treatment group, baseline evening PEF, region, visit, and treatment by visit interaction.||||40.46|-10.08|0.237
70985138|NCT02075255|141479337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.52||||0.014|TWO_SIDED|95.0|6.32|56.71|||Mixed Models Analysis|Include covariates: treatment group, baseline evening PEF, region, visit, and treatment by visit interaction.||||56.71|6.32|0.014
70985139|NCT02075255|141479338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.742|TWO_SIDED|95.0|-0.08|0.11|||Mixed Models Analysis|Including covariates: treatment group, baseline proportion of nights with noctural awakenings, region, visit, and treatment by visit interaction.||||0.11|-0.08|0.742
70985140|NCT02075255|141479338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.693|TWO_SIDED|95.0|-0.11|0.07|||Mixed Models Analysis|Including covariates: treatment group, baseline proportion of nights with noctural awakenings, region, visit, and treatment by visit interaction.||||0.07|-0.11|0.693
70985141|NCT02075255|141479339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.139|TWO_SIDED|95.0|-0.55|0.08|||Mixed Models Analysis|Include covariates: treatment group, baseline ACQ-6 score, region, visit, and treatment by visit interaction.||||0.08|-0.55|0.139
70985142|NCT02075255|141479339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.001|TWO_SIDED|95.0|-0.86|-0.23|||Mixed Models Analysis|Include covariates: treatment group, baseline ACQ-6 score, region, visit, and treatment by visit interaction.||||-0.23|-0.86|0.001
70985143|NCT02075255|141479340|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.165||||0.658|TWO_SIDED|95.0|0.592|2.295|||Regression, Logistic|Including covariates: treatment group, baseline ACQ-6 score, region, number of exacerbations in the previous year.||||2.295|0.592|0.658
70985144|NCT02075255|141479340|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.661||||0.155|TWO_SIDED|95.0|0.826|3.34|||Regression, Logistic|Including covariates: treatment group, baseline ACQ-6 score, region, number of exacerbations in the previous year.||||3.340|0.826|0.155
70985145|NCT02075255|141479341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.151|TWO_SIDED|95.0|-0.08|0.53|||Mixed Models Analysis|Including covariates: treatment group, region, baseline AQLQ(S)+12 score, visit, and treatment by visit interaction.||||0.53|-0.08|0.151
70985146|NCT02075255|141479341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.004|TWO_SIDED|95.0|0.14|0.76|||Mixed Models Analysis|Including covariates: treatment group, region, baseline AQLQ(S)+12 score, visit, and treatment by visit interaction.||||0.76|0.14|0.004
70985147|NCT02075255|141479342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.538||||0.22|TWO_SIDED|95.0|0.773|3.06|||Regression, Logistic|Including covariates: treatment group, region, baseline AQLQ(S)+12 score, number of exacerbations in the previous year.||||3.060|0.773|0.220
70985148|NCT02075255|141479342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.783||||0.108|TWO_SIDED|95.0|0.882|3.605|||Regression, Logistic|Including covariates: treatment group, region, baseline AQLQ(S)+12 score, number of exacerbations in the previous year.||||3.605|0.882|0.108
70985149|NCT02075255|141479346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-162.2|||<|0.001|TWO_SIDED|95.0|-220.1|-104.3|||Mixed Models Analysis|Include covariates: treatment group, baseline eosinophil count, region, visit, treatment by visit|Percent change|||-104.3|-220.1|<0.001
70985150|NCT02075255|141479346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-159.4|||<|0.001|TWO_SIDED|95.0|-217.9|-100.9|||Mixed Models Analysis|Include covariates: treatment group, baseline eosinophil count, region, visit, treatment by visit.|Percent change|||-100.9|-217.9|<0.001
70985151|NCT03503773|141479352|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.2682|TWO_SIDED|95.0|-4.8|1.7|||ANCOVA||There was no formal hypothesis testing conducted in the study. 95% CIs are intended to be descriptive in nature only|The null hypothesis to be tested is that there is no difference in the change in 24 hour mean SBP between treatment and sham control. The Type I error rate for rejecting the null hypothesis will be set at an alpha level of 0.05.||1.7|-4.8|0.2682
70985152|NCT03503773|141479353|SUPERIORITY|||||||0.6964|||||||ANCOVA|||Difference between treatment arms||||0.6964
70985153|NCT03503773|141479354|SUPERIORITY|||||||0.0775|||||||ANCOVA|||Between group difference||||0.0775
70985154|NCT03503773|141479356|SUPERIORITY|||||||0.4734|||||||ANCOVA|||Between group difference||||0.4734
70985155|NCT03503773|141479358|SUPERIORITY|||||||0.0341|||||||ANCOVA|||||||0.0341
70985156|NCT03503773|141479360|SUPERIORITY||Mean Difference (Final Values)|-0.029||||0.573|TWO_SIDED|95.0|-0.132|0.073|||Fisher Exact|||||0.073|-0.132|0.573
70985157|NCT01208181|141479407|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|-0.29||||0.004|TWO_SIDED|95.0|-0.49|-0.09|||Tukey-Ciminera-Heysetrend test|||||-0.09|-0.49|0.004
70985158|NCT01208181|141479407|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|-0.27||||0.034|TWO_SIDED|95.0|-0.48|-0.06|||Tukey-Ciminera-Heysetrend test|||||-0.06|-0.48|0.034
71097793|NCT05330429|141704103|SUPERIORITY||Hazard Ratio (HR)|0.299|||||TWO_SIDED|95.0|0.056|1.6|||||Hazard ratio and its 95% CI were calculated using unstratified Cox proportional hazards regression model.|||1.600|0.056|
71097794|NCT06097273|141704110|NON_INFERIORITY|The noninferiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.155|||||TWO_SIDED|97.5|1.086|1.229||||||GMR (Cohort A1 vs Cohort A2) for Influenza A H1N1 Antibody||1.229|1.086|
70985159|NCT01208181|141479408|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|-7.99|||<|0.001|TWO_SIDED|95.0|-11.85|-4.13|||Tukey-Ciminera-Heyse trend test|||||-4.13|-11.85|<0.001
70985160|NCT01208181|141479408|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|-10.7|||<|0.001|TWO_SIDED|95.0|-14.74|-6.66|||Tukey-Ciminera-Heyse trend test|||||-6.66|-14.74|<0.001
70985161|NCT01208181|141479409|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|0.02||||0.73|TWO_SIDED|95.0|-0.1|0.14|||Tukey-Ciminera-Heysetrend test|||||0.14|-0.10|0.730
70985162|NCT01208181|141479410|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|-2.71||||0.019|TWO_SIDED|95.0|-4.98|-0.45|||Tukey-Ciminera-Heyse trend test|||||-0.45|-4.98|0.019
70985163|NCT01208181|141479411|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares mean|1.61||||0.327|TWO_SIDED|80.0|-0.49|3.71|||covariance model|||||3.71|-0.49|0.327
70985164|NCT03694522|141479535|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0727|TWO_SIDED|95.0|0.44|1.04|||Stratified log-rank test|Adjusted for randomization stratification factors of geographic region and administration of mFOLFOX6 single dose prior to randomization.|Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model, adjusted for randomization stratification factors, including geographic region and administration of mFOLFOX6 single dose prior to randomization.|||1.04|0.44|0.0727
70985165|NCT03694522|141479536|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.0268|TWO_SIDED|95.0|0.35|0.95|||Stratified log-rank test|Adjusted for randomization stratification factors, including geographic region and administration of mFOLFOX6 single dose prior to randomization.|Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model, adjusted for randomization stratification factors, including geographic region and administration of mFOLFOX6 single dose prior to randomization.|||0.95|0.35|0.0268
70985166|NCT03694522|141479537|SUPERIORITY||Difference|13.1||||0.106|TWO_SIDED|95.0|-2.8|29.0|||Cochran-Mantel-Haenszel|P-value was calculated based on stratum-adjusted Cochran-Mantel-Haenszel (CMH) proportions||||29.0|-2.8|0.1060
70985167|NCT03694522|141479539|SUPERIORITY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.38|0.94|||||Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model, adjusted for randomization stratification factors, including geographic region and administration of mFOLFOX6 single dose prior to randomization.|||0.94|0.38|
70985168|NCT01748760|141479540|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Chi-squared|||||||.87
71097795|NCT06097273|141704110|SUPERIORITY|The superiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% confidence interval (CI) of the geometric mean ratio (GMR) was \>1.|GMR|1.155|||||TWO_SIDED|95.0|1.094|1.22||||||GMR (Cohort A1 vs Cohort A2) for Influenza A H1N1 Antibody||1.220|1.094|
71097796|NCT06097273|141704110|NON_INFERIORITY|The noninferiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.063|||||TWO_SIDED|97.5|0.999|1.13||||||GMR (Cohort A1 vs Cohort A2) for Influenza A H3N2 Antibody||1.130|0.999|
71037565|NCT02554877|141582190|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-2.03|STANDARD_ERROR_OF_MEAN|2.49||0.4173|TWO_SIDED|90.0|-6.15|2.09||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||2.09|-6.15|0.4173
71037566|NCT02554877|141582190|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.98|STANDARD_ERROR_OF_MEAN|2.56||0.7036|TWO_SIDED|90.0|-5.21|3.26||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||3.26|-5.21|0.7036
71037567|NCT02554877|141582190|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-2.64|STANDARD_ERROR_OF_MEAN|2.54||0.2993|TWO_SIDED|90.0|-6.84|1.56||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||1.56|-6.84|0.2993
71037568|NCT02554877|141582190|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.08|STANDARD_ERROR_OF_MEAN|2.57||0.9751|TWO_SIDED|90.0|-4.16|4.32||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||4.32|-4.16|0.9751
71037569|NCT02554877|141582190|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|4.23|STANDARD_ERROR_OF_MEAN|2.86||0.1408|TWO_SIDED|90.0|-0.5|8.96||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||8.96|-0.50|0.1408
71037570|NCT02554877|141582190|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|4.7|STANDARD_ERROR_OF_MEAN|2.83||0.0986|TWO_SIDED|90.0|0.02|9.38||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||9.38|0.02|0.0986
71037571|NCT02554877|141582190|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.79|STANDARD_ERROR_OF_MEAN|2.85||0.1851|TWO_SIDED|90.0|-0.92|8.5||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||8.50|-0.92|0.1851
71037572|NCT02554877|141582191|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.39|STANDARD_ERROR_OF_MEAN|2.17||0.8559|TWO_SIDED|90.0|-3.19|3.98||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||3.98|-3.19|0.8559
71097797|NCT06097273|141704110|SUPERIORITY|The superiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.063|||||TWO_SIDED|95.0|1.007|1.122||||||GMR (Cohort A1 vs Cohort A2) for Influenza A H3N2 Antibody||1.122|1.007|
71037573|NCT02554877|141582191|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|2.97|STANDARD_ERROR_OF_MEAN|2.17||0.1729|TWO_SIDED|90.0|-0.62|6.55||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||6.55|-0.62|0.1729
71097798|NCT06097273|141704110|NON_INFERIORITY|The noninferiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.414|||||TWO_SIDED|97.5|1.322|1.513||||||GMR (Cohort B1 vs Cohort B2) for Influenza A H1N1 Antibody||1.513|1.322|
71037574|NCT02554877|141582191|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|8.45|STANDARD_ERROR_OF_MEAN|2.18||0.0002|TWO_SIDED|90.0|4.84|12.06||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||12.06|4.84|0.0002
71037575|NCT02554877|141582191|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.37|STANDARD_ERROR_OF_MEAN|2.55||0.8837|TWO_SIDED|90.0|-3.85|4.59||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||4.59|-3.85|0.8837
71037576|NCT02554877|141582191|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.62|STANDARD_ERROR_OF_MEAN|2.55||0.1573|TWO_SIDED|90.0|-0.6|7.84||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||7.84|-0.60|0.1573
71037577|NCT02554877|141582191|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|7.88|STANDARD_ERROR_OF_MEAN|2.56||0.0024|TWO_SIDED|90.0|3.65|12.11||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||12.11|3.65|0.0024
71037578|NCT02554877|141582191|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.59|STANDARD_ERROR_OF_MEAN|2.51||0.1538|TWO_SIDED|90.0|-0.55|7.73||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||7.73|-0.55|0.1538
71037579|NCT02554877|141582191|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|4.39|STANDARD_ERROR_OF_MEAN|2.48||0.0789|TWO_SIDED|90.0|0.28|8.49||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||8.49|0.28|0.0789
71037580|NCT02554877|141582191|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|10.14|STANDARD_ERROR_OF_MEAN|2.51|<|0.0001|TWO_SIDED|90.0|5.98|14.3||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||14.30|5.98|<0.0001
71037581|NCT02554877|141582191|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|6.96|STANDARD_ERROR_OF_MEAN|2.78||0.0132|TWO_SIDED|90.0|2.36|11.56||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||11.56|2.36|0.0132
71037582|NCT02554877|141582191|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|7.41|STANDARD_ERROR_OF_MEAN|2.75||0.0079|TWO_SIDED|90.0|2.85|11.96||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||11.96|2.85|0.0079
71037583|NCT02554877|141582191|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|10.83|STANDARD_ERROR_OF_MEAN|2.77||0.0001|TWO_SIDED|90.0|6.24|15.42||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||15.42|6.24|0.0001
71037584|NCT02554877|141582192|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.46|STANDARD_ERROR_OF_MEAN|3.31||0.6597|TWO_SIDED|90.0|-4.01|6.92||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||6.92|-4.01|0.6597
71037585|NCT02554877|141582192|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.02|STANDARD_ERROR_OF_MEAN|3.31||0.7583|TWO_SIDED|90.0|-4.45|6.49||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||6.49|-4.45|0.7583
70985169|NCT01164501|141479541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.62|-0.39||Hierarchical testing to adjust for multiple comparisons, no adjustment in p-values. Empa 25 mg versus placebo in mild or moderate renal impaired patients was the first step in the hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal impairment and baseline HbA1c.|Difference calculated as empa 25mg minus placebo|||-0.39|-0.62|<0.0001
70985170|NCT01164501|141479542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.72|-0.32||Hierarchical testing to adjust for multiple comparisons, no adjustment in p-values. Empa 25 mg versus placebo in mild renal impaired patients was the second step in the hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication and baseline HbA1c.|Difference calculated as empa 10mg minus placebo|||-0.32|-0.72|<0.0001
70985171|NCT01164501|141479542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.88|-0.49||Hierarchical testing to adjust for multiple comparisons, no adjustment in p-values. Empa 10 mg versus placebo in mild renal impaired patients was the third step in the hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication and baseline HbA1c.|Difference calculated as empa 25mg minus placebo|||-0.49|-0.88|<0.0001
70985172|NCT01164501|141479543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.56|-0.28||Hierarchical testing to adjust for multiple comparisons, no adjustment in p-values. Empa 10 mg versus placebo in moderate renal impaired patients was the fourth step in the hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication and baseline HbA1c.|Difference calculated as empa 25mg minus placebo|||-0.28|-0.56|<0.0001
71037586|NCT02554877|141582192|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.11|STANDARD_ERROR_OF_MEAN|3.33||0.3516|TWO_SIDED|90.0|-2.39|8.61||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||8.61|-2.39|0.3516
71037587|NCT02554877|141582192|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.83|STANDARD_ERROR_OF_MEAN|3.38||0.5877|TWO_SIDED|90.0|-7.42|3.75||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||3.75|-7.42|0.5877
71037588|NCT02554877|141582192|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-4.33|STANDARD_ERROR_OF_MEAN|3.38||0.2016|TWO_SIDED|90.0|-9.92|1.26||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||1.26|-9.92|0.2016
71037589|NCT02554877|141582192|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-6.49|STANDARD_ERROR_OF_MEAN|3.39||0.0568|TWO_SIDED|90.0|-12.08|-0.89||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||-0.89|-12.08|0.0568
71097799|NCT06097273|141704110|SUPERIORITY|The superiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.414|||||TWO_SIDED|95.0|1.333|1.5||||||GMR (Cohort B1 vs Cohort B2) for Influenza A H1N1 Antibody||1.500|1.333|
71097800|NCT06097273|141704110|NON_INFERIORITY|The noninferiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.38|||||TWO_SIDED|97.5|1.3|1.465||||||GMR (Cohort B1 vs Cohort B2) for Influenza A H3N2 Antibody||1.465|1.300|
70985173|NCT02522377|141479545|SUPERIORITY|Superiority test based upon group differences pooled across infusions|Mean Difference (Final Values)|1.22|STANDARD_ERROR_OF_MEAN|3.28||0.72|TWO_SIDED||||||Mixed Models Analysis|Model includes main effect for treatment group and infusion number categorically. Satterthwaite DF=9.987.|Midazolam - Ketamine Infusions|||||0.72
70985174|NCT02522377|141479546|SUPERIORITY|Superiority test based upon group differences pooled across infusions in mixed effect model|Mean Difference (Final Values)|1.98|STANDARD_ERROR_OF_MEAN|6.4||0.77|TWO_SIDED||||||Mixed Models Analysis|Model includes main effect for treatment group and infusion number categorically. Satterthwaite DF=7.836.|Midazolam - Ketamine Infusions|||||0.77
70985175|NCT02522377|141479547|SUPERIORITY|Superiority test based upon group differences pooled across infusions|Mean Difference (Final Values)|0.98|STANDARD_ERROR_OF_MEAN|1.12||0.4|TWO_SIDED||||||Mixed Models Analysis|Model includes main effect for treatment group and infusion number categorically. Satterthwaite DF=9.987.|Midazolam - Ketamine Infusions|||||0.40
70985176|NCT02522377|141479548|SUPERIORITY|Superiority test based upon group differences pooled across infusions|Mean Difference (Final Values)|1.78|STANDARD_ERROR_OF_MEAN|0.54||0.009|TWO_SIDED||||||Mixed Models Analysis|Model includes main effect for treatment group and infusion number categorically. Satterthwaite DF=9.3634.|Midazolam - Ketamine Infusions|||||0.009
70985177|NCT02522377|141479549|SUPERIORITY|Superiority test based upon group differences pooled across infusions|Mean Difference (Final Values)|3.72|STANDARD_ERROR_OF_MEAN|3.71||0.34|TWO_SIDED||||||Mixed Models Analysis|Model includes main effect for treatment group and infusion number categorically. Satterthwaite DF=9.987.|Midazolam - Ketamine Infusions|||||0.34
70985178|NCT02522377|141479550|SUPERIORITY||Odds Ratio (OR)|0.36||||0.58|TWO_SIDED|95.0|0.01|7.2|||Fisher Exact||Odds Ratio of Midazolam (numerator) to Ketamine Infusions (denominator)|||7.20|0.01|0.58
70985179|NCT01004107|141479569|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
70985180|NCT01004107|141479570|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
70985181|NCT01004107|141479571|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
70985182|NCT01004107|141479572|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
70985183|NCT01004107|141479575|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70985184|NCT01004107|141479576|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
70985185|NCT01748695|141479596|SUPERIORITY_OR_OTHER|||||||0.834||||||Based on a linear mixed measures model with treatment and period included as fixed effects, subject included as a random effect and between- and within- subject baseline covariates included.|Regression, Linear|||||||0.834
70985186|NCT01707147|141479624|OTHER||Mean Difference (Final Values)|-0.77|STANDARD_DEVIATION|1.5|<|0.0001|TWO_SIDED|95.0|-0.83|-0.71|||Paired t-test||p-value of paired t-test for change from baseline is presented. 95% confidence interval for the mean was calculated using t-distribution.|||-0.71|-0.83|<0.0001
70985187|NCT01707147|141479627|OTHER||Mean Difference (Final Values)|-18.05|STANDARD_DEVIATION|61.84|<|0.0001|TWO_SIDED|95.0|-20.98|-15.12|||Paired t-test||p-value of paired t-test for change from baseline is presented. 95% confidence interval for the mean was calculated using t-distribution.|||-15.12|-20.98|<0.0001
70985188|NCT01040832|141479634|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.793|TWO_SIDED|95.0|0.7|1.6|||Stratified log rank|||||1.6|0.7|0.793
70985189|NCT01040832|141479635|SUPERIORITY_OR_OTHER||||||>|0.999||95.0|||||Cochran-Mantel-Haenszel|||||||>0.999
70985190|NCT01040832|141479636|SUPERIORITY_OR_OTHER|||||||0.557||95.0|||||Cochran-Mantel-Haenszel|||||||0.557
70985191|NCT01592851|141479643|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.83|||<|0.0001|TWO_SIDED|95.0|-1.03|-0.63||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a negative difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||-0.63|-1.03|<0.0001
70985192|NCT01592851|141479644|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.26||||0.0006|TWO_SIDED|95.0|-0.41|-0.12||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a negative difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||-0.12|-0.41|0.0006
70985193|NCT01592851|141479645|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.45|||<|0.0001|TWO_SIDED|95.0|-0.63|-0.28||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a negative difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||-0.28|-0.63|<0.0001
70985194|NCT01592851|141479646|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|19.42|||<|0.0001|TWO_SIDED|95.0|13.7|25.15||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a positive difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||25.15|13.70|<0.0001
70985195|NCT01592851|141479647|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.84||||0.0021|TWO_SIDED|95.0|2.54|11.13||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a positive difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||11.13|2.54|0.0021
70985196|NCT01592851|141479648|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|3.87||||0.007|TWO_SIDED|95.0|1.08|6.65||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a positive difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||6.65|1.08|0.0070
70985197|NCT02940886|141479657|NON_INFERIORITY|Non-inferiority could be claimed if the lower bound of the 95% confidence interval (CI) was above -0.5 g/dL.|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.13|0.13|||||Mixed Model for Repeated Measurement was used for testing and included the fixed categorical effects of treatment, week, treatment-by-week interaction, strata, and the continuous covariates of baseline Hb and baseline Hb-by-week interaction.|"Power:~With N=1000 subjects in the iron isomaltoside/ferric derisomaltose treatment group and with N=500 subjects in the iron sucrose treatment group, assuming no difference between the treatment groups and assuming a common standard deviation (SD) of 1.5 g/dL, the power was 100% for demonstrating non-inferiority of the change in Hb from baseline to week 8, using a non-inferiority margin of -0.5 g/dL.~The significance level was set to 5%."||0.13|-0.13|
70985198|NCT02940886|141479658|OTHER||95% two-sided CI (iron isomaltoside)|0.3|||||TWO_SIDED|95.0|0.06|0.88||||||"Power:~With N=1000 subjects in the iron isomaltoside/ferric derisomaltose, the power was 88% to demonstrate that the upper bound of the 95% CI of the incidence of treatment-emergent serious and/or severe non-serious hypersensitivity AEs was less than 3%.~The significance level was set to 5%."||0.88|0.06|
70985199|NCT02940886|141479658|OTHER||Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.91|0.71||||||Risk difference between iron isomaltoside/ferric derisomaltose and iron sucrose was assessed for the individual trial with 95% Newcombe CI adjusted for stratum using the Cochran-Mantel-Haenszel method.||0.71|-0.91|
70985200|NCT02940886|141479658|NON_INFERIORITY|Non-inferiority can be claimed if the upper bound of the 95% CI is below 1.5 % point.|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.57|0.48||||||Risk difference between iron isomaltoside/ferric derisomaltose and iron sucrose was assessed for the pooled FERWON-IDA and FERWON-NEPHRO trials (2008 subjects treated with iron isomaltoside/ferric derisomaltose and 1000 subjects treated with iron sucrose) with 95% Newcombe CI adjusted for stratum using the Cochran-Mantel-Haenszel method.||0.48|-0.57|
70985201|NCT02940886|141479659|SUPERIORITY|||||||0.5695|||||||Fisher Exact|||Adjudicated and confirmed treatment-emergent composite cardiovascular AEs. Any treatment emergent composite cardiovascular AEs were included in the statistical evaluation. The overall incidence of adjudicated and confirmed composite cardiovascular AEs was tabulated and compared between the treatment groups by a Fisher's exact test.||||0.5695
70985202|NCT02940886|141479660|SUPERIORITY|||||||0.3913|||||||Log Rank|||The time to first adjudicated and confirmed composite cardiovascular AEs was estimated using the Kaplan-Meier method and the hypothesis of no treatment difference was assessed by a log-rank test.||||0.3913
71037590|NCT02554877|141582192|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-2.94|STANDARD_ERROR_OF_MEAN|3.36||0.3827|TWO_SIDED|90.0|-8.48|2.61||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||2.61|-8.48|0.3827
71037591|NCT02554877|141582192|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-5.31|STANDARD_ERROR_OF_MEAN|3.33||0.1126|TWO_SIDED|90.0|-10.81|0.2||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||0.20|-10.81|0.1126
71037592|NCT02554877|141582192|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-4.17|STANDARD_ERROR_OF_MEAN|3.36||0.216|TWO_SIDED|90.0|-9.73|1.38||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||1.38|-9.73|0.2160
71037593|NCT02554877|141582192|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.54|STANDARD_ERROR_OF_MEAN|3.74||0.3443|TWO_SIDED|90.0|-2.64|9.72||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||9.72|-2.64|0.3443
71037594|NCT02554877|141582192|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.82|STANDARD_ERROR_OF_MEAN|3.7||0.3031|TWO_SIDED|90.0|-2.3|9.94||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||9.94|-2.30|0.3031
71037595|NCT02554877|141582192|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.88|STANDARD_ERROR_OF_MEAN|3.72||0.8129|TWO_SIDED|90.0|-5.27|7.04||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||7.04|-5.27|0.8129
71037596|NCT02554877|141582193|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.34|STANDARD_ERROR_OF_MEAN|0.4||0.402|TWO_SIDED|90.0|-0.33|1.01||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||1.01|-0.33|0.4020
71037597|NCT02554877|141582193|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.06|STANDARD_ERROR_OF_MEAN|0.4||0.8789|TWO_SIDED|90.0|-0.61|0.73||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||0.73|-0.61|0.8789
71037598|NCT02554877|141582193|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.87|STANDARD_ERROR_OF_MEAN|0.41||0.0345|TWO_SIDED|90.0|0.19|1.54||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||1.54|0.19|0.0345
71097801|NCT06097273|141704110|SUPERIORITY|The superiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.38|||||TWO_SIDED|95.0|1.31|1.454||||||GMR (Cohort B1 vs Cohort B2) for Influenza A H3N2 Antibody||1.454|1.310|
70985203|NCT02940886|141479662|SUPERIORITY||Odds Ratio (OR)|2.44||||0.0077|TWO_SIDED|95.0|1.27|4.72|||Repeated measures logistic regressioin|||"Week 1~Hb increase of ≥2 g/dL from baseline to week 1.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||4.72|1.27|0.0077
70985204|NCT02940886|141479662|SUPERIORITY||Odds Ratio (OR)|2.42|||<|0.0001|TWO_SIDED|95.0|1.8|3.26|||Repeated measures logistic regressioin|||"Week 2~Hb increase of ≥2 g/dL from baseline to week 2.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||3.26|1.80|<0.0001
70985205|NCT02940886|141479662|SUPERIORITY||Odds Ratio (OR)|1.23||||0.1049|TWO_SIDED|95.0|0.96|1.58|||Repeated measures logistic regressioin|||"Week 4~Hb increase of ≥2 g/dL from baseline to week 4.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||1.58|0.96|0.1049
70985206|NCT02940886|141479662|SUPERIORITY||Odds Ratio (OR)|1.05||||0.7032|TWO_SIDED|95.0|0.8|1.38|||Repeated measures logistic regressioin|||"Week 8~Hb increase of ≥2 g/dL from baseline to week 8.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||1.38|0.80|0.7032
70985207|NCT02940886|141479663|SUPERIORITY|||||||0.088|||||||Log Rank|||Time to Hb response was estimated using the Kaplan-Meier method and the hypothesis of no treatment difference was assessed by a 2-sided log-rank test.||||0.0880
70985208|NCT02940886|141479664|SUPERIORITY||Odds Ratio (OR)|1.14||||0.242|TWO_SIDED|95.0|0.92|1.41|||Regression, Logistic|||The proportion of subjects who achieved a Hb level of \>12 g/dL at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects. The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose is presented with 95% CI and corresponding p-value.||1.41|0.92|0.2420
70985209|NCT02940886|141479665|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8746|TWO_SIDED|95.0|0.81|1.28|||Regression, Logistic|||"The proportion of subjects who achieved an increase in Hb concentration ≥2 g/dL at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects.~The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose was presented with 95% CI and corresponding p-value."||1.28|0.81|0.8746
70985210|NCT02940886|141479666|SUPERIORITY||Odds Ratio (OR)|4.52|||<|0.0001|TWO_SIDED|95.0|3.58|5.71|||Regression, Logistic|||"Proportion of subject who achieved a s-ferritin level of ≥100 ng/mL AND a TSAT of 20-50% at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects.~The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose is presented with 95% CI and corresponding p-value."||5.71|3.58|<0.0001
70985211|NCT02940886|141479667|SUPERIORITY||Mean Difference (Final Values)|0.26|||<|0.0001|TWO_SIDED|95.0|0.19|0.34|||Mixed model for repeated measures|||"Week 1~Change in Hb concentration from baseline to week 1 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."||0.34|0.19|<0.0001
70985212|NCT02940886|141479667|SUPERIORITY||Mean Difference (Final Values)|0.29|||<|0.0001|TWO_SIDED|95.0|0.19|0.38|||Mixed model for repeated measures|||"Week 2~Change in Hb concentration from baseline to week 2 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."||0.38|0.19|<0.0001
70985213|NCT02940886|141479667|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.1091|TWO_SIDED|95.0|-0.02|0.2|||Mixed model for repeated measures|||"Week 4~Change in Hb concentration from baseline to week 4 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."||0.20|-0.02|0.1091
71097802|NCT06097273|141704110|NON_INFERIORITY|The noninferiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.118|||||TWO_SIDED|97.5|1.063|1.175||||||GMR (Cohort A1 vs Cohort A2) for Influenza B Victoria-lineage Antibody||1.175|1.063|
70985214|NCT02940886|141479668|SUPERIORITY||Mean Difference (Final Values)|267.7|||<|0.0001|TWO_SIDED|95.0|246.3|289.0|||Mixed model for repeated measures|||"Week 1~Change in concentrations of s-ferritin from baseline to week 1 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||289.0|246.3|<0.0001
70985215|NCT02940886|141479668|SUPERIORITY||Mean Difference (Final Values)|41.7|||<|0.0001|TWO_SIDED|95.0|25.6|57.8|||Mixed model for repeated measures|||"Week 2~Change in concentrations of s-ferritin from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||57.8|25.6|<0.0001
70985216|NCT02940886|141479668|SUPERIORITY||Mean Difference (Final Values)|-9.0||||0.115|TWO_SIDED|95.0|-20.3|2.2|||Mixed model for repeated measures|||"Week 4~Change in concentrations of s-ferritin from baseline to week 4 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||2.2|-20.3|0.1150
71097803|NCT06097273|141704110|SUPERIORITY|The superiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.118|||||TWO_SIDED|95.0|1.07|1.167||||||GMR (Cohort A1 vs Cohort A2) for Influenza B Victoria-lineage Antibody||1.167|1.070|
71097804|NCT06097273|141704110|NON_INFERIORITY|The noninferiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.007|||||TWO_SIDED|97.5|0.969|1.047||||||GMR (Cohort A1 vs Cohort A2) for Influenza B Yamagata-lineage Antibody||1.047|0.969|
70985217|NCT02940886|141479668|SUPERIORITY||Mean Difference (Final Values)|-8.3||||0.0812|TWO_SIDED|95.0|-17.7|1.0|||Mixed model for repeated measures|||"Week 8~Change in concentrations of s-ferritin from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||1.0|-17.7|0.0812
70985218|NCT02940886|141479669|SUPERIORITY||Mean Difference (Final Values)|11.4|||<|0.0001|TWO_SIDED|95.0|10.1|12.7|||Mixed model for repeated measures|||"Week 1~Change in TSAT from baseline to week 1 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||12.7|10.1|<0.0001
70985219|NCT02940886|141479669|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.0001|TWO_SIDED|95.0|1.2|3.6|||Mixed model for repeated measures|||"Week 2~Change in TSAT from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||3.6|1.2|0.0001
70985220|NCT02940886|141479669|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.0162|TWO_SIDED|95.0|0.2|2.1|||Mixed model for repeated measures|||"Week 4~Change in TSAT from baseline to week 4 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||2.1|0.2|0.0162
70985221|NCT02940886|141479669|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.0569|TWO_SIDED|95.0|0.0|1.8|||Mixed model for repeated measures|||"Week 8~Change in TSAT from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||1.8|0.0|0.0569
70985222|NCT02940886|141479670|SUPERIORITY||Mean Difference (Final Values)|43.7|||<|0.0001|TWO_SIDED|95.0|38.1|49.3|||Mixed model for repeated measures|||"Week 1~Change in s-iron from baseline to week 1 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, including 95% CIs and corresponding p-value."||49.3|38.1|<0.0001
70985223|NCT02940886|141479670|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.0375|TWO_SIDED|95.0|0.3|9.8|||Mixed model for repeated measures|||"Week 2~Change in s-iron from baseline to week 2 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, including 95% CIs and corresponding p-value."||9.8|0.3|0.0375
70985224|NCT02940886|141479670|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.6027|TWO_SIDED|95.0|-4.0|2.3|||Mixed model for repeated measures|||"Week 4~Change in s-iron from baseline to week 4 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, including 95% CIs and corresponding p-value."||2.3|-4.0|0.6027
70985225|NCT02940886|141479670|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.8207|TWO_SIDED|95.0|-2.7|3.4|||Mixed model for repeated measures|||"Week 8~Change in s-iron from baseline to week 8 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, including 95% CIs and corresponding p-value."||3.4|-2.7|0.8207
70985226|NCT02940886|141479671|SUPERIORITY||Mean Difference (Final Values)|1.02||||0.0422|TWO_SIDED|95.0|0.04|2.01|||Mixed model for repeated measures|||"Week 1~Change in fatigue symptoms score from baseline to week 1 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."||2.01|0.04|0.0422
70985227|NCT02940886|141479671|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.4646|TWO_SIDED|95.0|-1.44|0.66|||Mixed model for repeated measures|||"Week 2~Change in fatigue symptoms score from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."||0.66|-1.44|0.4646
70985228|NCT02940886|141479671|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.5703|TWO_SIDED|95.0|-1.39|0.76|||Mixed model for repeated measures|||"Week 8~Change in fatigue symptoms score from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."||0.76|-1.39|0.5703
70985229|NCT01306058|141479693|NON_INFERIORITY|Paired T-test. Two tailed.|||||<|0.05|||||||Wilcoxon signed rank test|||||||<0.05
70985230|NCT01306058|141479694|NON_INFERIORITY|Paired T-test. Two tailed.|||||<|0.0001||||||Cycle 1 day 15 vs. cycle 1 day 1|Wilcoxon signed rank test|||||||<0.0001
70985231|NCT01306058|141479694|NON_INFERIORITY|Cycle 2 day 1 vs. cycle 1 day 1. Paired T-test. Two tailed.|||||<|0.0001|||||||Wilcoxon signed rank test|||||||<0.0001
70985232|NCT01306058|141479694|NON_INFERIORITY|eos (end of study) vs. cycle 1 day 1. Paired T-test. Two tailed.||||||0.0009|||||||Wilcoxon signed rank test|||||||0.0009
70985233|NCT01666444|141479696|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.22||||0.923|ONE_SIDED|92.0||1.48||P-value is for a one-sided hypothesis test.|Log Rank|The logrank test is stratified for platinum-free interval (\<= 6 months vs \> 6 months), and performance status (0 vs 1).|Treatment Hazard ratio for overall survival (PLD+VTX relative to PLD+placebo). Survival is measured from date of enrollment and randomization on the study until death from any cause, or date of last contact.|The null hypothesis is that the hazards of death are equal for both treatment groups. The primary assessment of this hypothesis was done with a stratified logrank test and the study was to be considered sufficiently mature to assess this hypothesis when at least 211 deaths had occurred among all individuals enrolled. Type I error was to be set to 0.08 for a one-sided test and the power for detecting a 30% reduction in the hazard (hazard ratio=0.70) due to VTX-2337 was 88.2%.||1.48||0.923
70985234|NCT01666444|141479697|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.21||||0.943|ONE_SIDED|98.0||1.56||P-value is for a one-sided hypothesis test.|Log Rank|The logrank test is stratified for platinum-free interval (\<= 6 months vs \> 6 months), and performance status (0 vs 1).||The null hypothesis is that the hazards of first progression or death are equal for both treatment groups. The primary assessment was to use a stratified logrank test and the study was to be considered sufficiently mature when survival is mature for analysis. Type I error was to be set to 0.02 for a one-sided test and the power for detecting a 31% reduction in the hazard (hazard ratio=0.69) due to VTX-2337 was expected to be approximately 83%.||1.56||0.943
70985235|NCT04011436|141479708|SUPERIORITY|In the bivariate analysis, a comparison was initially made of each of the domains of the Kujala test, for the assessment of pain at baseline, assessing the differences between the intervention groups using the chi-square or Fisher's exact tests. The Spearman correlation coefficient was used to evaluate the relationship between two continuous variables, such as Q angle and anterior knee pain, assessing the correlation marginally and conditionally on each of the treatment groups.|difference in frequency distribution|0.05|||<|0.05|TWO_SIDED|95.0|0.025|0.05|||Fisher Exact|we also used Chi-squared for the domains of pain and limp.||||0.05|0.025|<0.05
70985236|NCT04011436|141479709|SUPERIORITY|For the analysis of the differences in medians between the groups, taking into account that the outcomes did not present a normal distribution, and assuming the assumption of independence of the variables, the non-parametric Mann-Whitney U test was used.|Median Difference (Final Values)|0.058|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Estimated Value was done for the assessment of change in pain with Visual Analogue Scale.~The dispersion parameter that was calculated were interquartile ranges for the differences in medians between groups."|||||<0.05
70985237|NCT04011436|141479710|SUPERIORITY||Median Difference (Final Values)|0.75|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Estimated value was calculated for Change in Patellofemoral Misalignment With Q Angle´s Exam.~The dispersion parameter that was calculated were interquartile ranges for the differences in medians between groups."|||||<0.05
70985238|NCT04011436|141479711|SUPERIORITY||Median Difference (Final Values)|0.001|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Estimated Value was calculated for the change in core strength with McGill´s Exam.~The dispersion parameter that was calculated were interquartile ranges for the differences in medians between groups."|||||<0.05
70985239|NCT04011436|141479712|SUPERIORITY||Median Difference (Final Values)|0.67|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Estimated value was calculated for the change in Quadriceps and Gluteus Strength With Squat´s Test.~The dispersion parameter that was calculated were interquartile ranges for the differences in medians between groups."|||||<0.05
70985240|NCT04011436|141479713|SUPERIORITY||Median Difference (Final Values)|0.55|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||||"Estimated value was calculated for the change in Static Balance with Single Leg Stance.~The dispersion parameter that was calculated were interquartile ranges for the differences in medians between groups."|||<0.05
70985241|NCT04011436|141479714|SUPERIORITY||Median Difference (Final Values)|0.492|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||||"Estimated value was calculated for the change in the total amount of Physical Activity reported in minutes.~The dispersion parameter that was calculated were interquartile ranges for the differences in medians between groups."|||<0.05
70985242|NCT00474630|141479745|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.28|||<|0.001||95.0|-4.34|-2.22|||ANCOVA|||||-2.22|-4.34|<0.001
70985243|NCT00474630|141479746|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49|||<|0.001|TWO_SIDED|95.0|-0.71|-0.27|||ANCOVA|||||-0.27|-0.71|<0.001
70985244|NCT00474630|141479747|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.44|||<|0.001|TWO_SIDED|95.0|2.15|5.5|||Regression, Logistic|||||5.50|2.15|<0.001
71097805|NCT06097273|141704110|SUPERIORITY|The superiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.007|||||TWO_SIDED|95.0|0.973|1.042||||||GMR (Cohort A1 vs Cohort A2) for Influenza B Yamagata-lineage Antibody||1.042|0.973|
70985245|NCT00474630|141479748|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.4||||0.007|TWO_SIDED||||||ANCOVA|||||||0.007
70985246|NCT00474630|141479749|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.32|||<|0.001|TWO_SIDED|95.0|1.8|4.84|||ANCOVA|||||4.84|1.80|<0.001
70985247|NCT00474630|141479750|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.85||||0.065|TWO_SIDED|95.0|-16.21|0.5|||ANCOVA|||||0.50|-16.21|0.065
70985248|NCT00474630|141479751|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.08|||||TWO_SIDED|95.0|-3.57|-0.59||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||-0.59|-3.57|
70985249|NCT00474630|141479752|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.75|||||TWO_SIDED|95.0|1.79|7.88||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||7.88|1.79|
71097806|NCT06097273|141704110|NON_INFERIORITY|The noninferiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.216|||||TWO_SIDED|97.5|1.156|1.278||||||GMR (Cohort B1 vs Cohort B2) for Influenza B Victoria-lineage Antibody||1.278|1.156|
71097807|NCT06097273|141704110|SUPERIORITY|The superiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.216|||||TWO_SIDED|95.0|1.163|1.27||||||GMR (Cohort B1 vs Cohort B2) for Influenza B Victoria-lineage Antibody||1.270|1.163|
70985250|NCT00474630|141479753|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.46|||||TWO_SIDED|95.0|1.5|4.04||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||4.04|1.50|
70985251|NCT00474630|141479754|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55|||||TWO_SIDED|95.0|0.35|0.86||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.86|0.35|
70985252|NCT00474630|141479755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43|||||TWO_SIDED|95.0|0.27|7.57||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||7.57|0.27|
70985253|NCT00474630|141479756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.63|||||TWO_SIDED|95.0|0.55|12.67||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||12.67|0.55|
70985254|NCT00474630|141479757|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.89|||||TWO_SIDED|||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||
70985255|NCT00474630|141479758|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.13|||||TWO_SIDED|||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||
70985256|NCT00474630|141479759|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.64|||||TWO_SIDED|95.0|1.36|5.14||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||5.14|1.36|
70985257|NCT00474630|141479760|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.37|||||TWO_SIDED|95.0|-0.77|3.51||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||3.51|-0.77|
71097808|NCT06097273|141704110|NON_INFERIORITY|The noninferiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.154|||||TWO_SIDED|97.5|1.109|1.201||||||GMR (Cohort B1 vs Cohort B2) for Influenza B Yamagata-lineage Antibody||1.201|1.109|
71097809|NCT06097273|141704110|SUPERIORITY|The superiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.154|||||TWO_SIDED|95.0|1.115|1.195||||||GMR (Cohort B1 vs Cohort B2) for Influenza B Yamagata-lineage Antibody||1.195|1.115|
70985258|NCT00474630|141479761|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.62|||||TWO_SIDED|||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||
70985259|NCT00474630|141479763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.98|||||TWO_SIDED|95.0|-9.22|-0.74||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||-0.74|-9.22|
70985260|NCT00474630|141479764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.43|||||TWO_SIDED|95.0|-7.48|4.62||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||4.62|-7.48|
70985261|NCT00474630|141479765|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.16|||||TWO_SIDED|95.0|-1.02|3.33||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||3.33|-1.02|
70985262|NCT00474630|141479766|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41|||||TWO_SIDED|95.0|-1.04|1.86||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.86|-1.04|
70985263|NCT00474630|141479767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.62|||||TWO_SIDED|95.0|0.59|2.65||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||2.65|0.59|
70985264|NCT00474630|141479768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.43|||||TWO_SIDED|95.0|-0.42|1.27||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.27|-0.42|
70985265|NCT00474630|141479769|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04|||||TWO_SIDED|96.0|-0.76|0.85||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.85|-0.76|
71008797|NCT02055976|141525256|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-51.08604|STANDARD_ERROR_OF_MEAN|2.88356|<|0.001|TWO_SIDED|95.0|-56.81235|-45.35973|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-45.35973|-56.81235|<0.001
71008798|NCT02055976|141525256|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-55.516|STANDARD_ERROR_OF_MEAN|2.91014|<|0.001|TWO_SIDED|95.0|-61.29424|-49.73777|||Mixed Models Analysis|||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-49.73777|-61.29424|<0.001
71097810|NCT06097273|141704111|SUPERIORITY|The superiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.641|||||TWO_SIDED|95.0|1.526|1.765||||||GMR (Cohort A1 vs Cohort A2) for SARS-CoV-2 Antibody||1.765|1.526|
71097811|NCT06097273|141704111|NON_INFERIORITY|The noninferiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.641|||||TWO_SIDED|97.5|1.51|1.783||||||GMR (Cohort A1 vs Cohort A2) for SARS-CoV-2 Antibody||1.783|1.510|
70985266|NCT00958568|141479772|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Log Rank|||Power estimate assumes approximately 1230 participants enter SPII. With a 60% drop-out/disqualification rate in SPII, then 492 participants enter SPIII. If 26% of participants drop out during SPIII, then 364 participants enter SPIV. Assuming 20% drop-out rate, 25% relapse rate on OFC and 40% relapse rate for fluoxetine (hazard ratio = 0.56), the log-rank test is 80% powered to detect a difference at a 2-sided 0.05 level. A total of 95 relapse events during SPIV should satisfy these assumptions.||||<0.001
70985267|NCT00958568|141479773|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|Relapse rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.||||||<0.001
70985268|NCT00958568|141479774|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|Relapse rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.||||||<0.001
70985269|NCT00958568|141479775|SUPERIORITY_OR_OTHER|||||||0.713||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|Relapse rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.||||||0.713
70985270|NCT00958568|141479776|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|Relapse rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.||||||<0.001
70985271|NCT00958568|141479777|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Log Rank|||||||<0.001
70985272|NCT00958568|141479778|SUPERIORITY_OR_OTHER|||||||0.831||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Log Rank|||||||0.831
70985273|NCT00958568|141479779|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Log Rank|||||||<0.001
70985274|NCT00958568|141479783|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|Remission rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.||||||0.047
71037599|NCT02554877|141582193|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.28|STANDARD_ERROR_OF_MEAN|0.48||0.0087|TWO_SIDED|90.0|0.48|2.08||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||2.08|0.48|0.0087
70985275|NCT00958568|141479784|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.91|STANDARD_ERROR_OF_MEAN|0.78|<|0.001|TWO_SIDED|95.0|-4.46|-1.36||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||-1.36|-4.46|<0.001
70985276|NCT00958568|141479785|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.82|||<|0.001|TWO_SIDED|95.0|-5.39|-2.24||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment and country.||||-2.24|-5.39|<0.001
70985277|NCT00958568|141479786|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.11||0.002|TWO_SIDED|95.0|-0.55|-0.12||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||-0.12|-0.55|0.002
70985278|NCT00958568|141479789|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.94|STANDARD_ERROR_OF_MEAN|0.72||0.007|TWO_SIDED|95.0|-3.36|-0.53||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment and country.||||-0.53|-3.36|0.007
70985279|NCT00958568|141479790|SUPERIORITY_OR_OTHER|||||||1||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||1.00
70985280|NCT00958568|141479791|SUPERIORITY_OR_OTHER|||||||0.248||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.248
70985281|NCT00958568|141479792|SUPERIORITY_OR_OTHER|||||||1||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||1.00
71037600|NCT02554877|141582193|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.08|STANDARD_ERROR_OF_MEAN|0.48||0.0268|TWO_SIDED|90.0|0.28|1.88||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||1.88|0.28|0.0268
70985282|NCT00958568|141479793|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|4.47||0.839|TWO_SIDED|95.0|-9.71|7.89||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||7.89|-9.71|0.839
70985283|NCT00958568|141479794|SUPERIORITY_OR_OTHER|||||||0.352||95.0||||P-value is for Borderline to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.352
70922818|NCT04950127|141336686|SUPERIORITY|Itch|Mean Difference (Net)|-0.58||||0.132|TWO_SIDED|95.0|-1.34|0.18||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.||0.18|-1.34|0.132
70985284|NCT00958568|141479794|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for Normal to Borderline. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||1.00
70985285|NCT00958568|141479794|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for Normal to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||1.00
70985286|NCT00958568|141479795|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.57|STANDARD_ERROR_OF_MEAN|4.12||0.703|TWO_SIDED|95.0|-9.69|6.54||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||6.54|-9.69|0.703
70985287|NCT00958568|141479796|SUPERIORITY_OR_OTHER|||||||0.139||95.0||||P-value is for Borderline to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.139
70985288|NCT00958568|141479796|SUPERIORITY_OR_OTHER|||||||0.746||95.0||||P-value is for Normal to Borderline. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.746
70985289|NCT00958568|141479796|SUPERIORITY_OR_OTHER|||||||0.458||95.0||||P-value is for Normal to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.458
70985290|NCT00958568|141479797|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.73|STANDARD_ERROR_OF_MEAN|1.15||0.001|TWO_SIDED|95.0|-5.99|-1.47||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||-1.47|-5.99|0.001
71037601|NCT02554877|141582193|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.39|STANDARD_ERROR_OF_MEAN|0.49||0.0047|TWO_SIDED|90.0|0.58|2.19||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||2.19|0.58|0.0047
71037602|NCT02554877|141582193|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.07|STANDARD_ERROR_OF_MEAN|0.42||0.0116|TWO_SIDED|90.0|0.38|1.76||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||1.76|0.38|0.0116
71037603|NCT02554877|141582193|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.97|STANDARD_ERROR_OF_MEAN|0.42||0.022|TWO_SIDED|90.0|0.27|1.66||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||1.66|0.27|0.0220
71037604|NCT02554877|141582193|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.31|STANDARD_ERROR_OF_MEAN|0.42||0.0021|TWO_SIDED|90.0|0.62|2.01||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||2.01|0.62|0.0021
71037605|NCT02554877|141582193|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.41|STANDARD_ERROR_OF_MEAN|0.51||0.0067|TWO_SIDED|90.0|0.56|2.26||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||2.26|0.56|0.0067
71037606|NCT02554877|141582193|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.18|STANDARD_ERROR_OF_MEAN|0.51||0.0225|TWO_SIDED|90.0|0.33|2.02||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||2.02|0.33|0.0225
71037607|NCT02554877|141582193|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.4|STANDARD_ERROR_OF_MEAN|0.51||0.0073|TWO_SIDED|90.0|0.55|2.25||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||2.25|0.55|0.0073
71097812|NCT06097273|141704111|SUPERIORITY|The superiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.308|||||TWO_SIDED|95.0|1.219|1.404||||||GMR (Cohort B1 vs Cohort B2) for SARS-CoV-2 Antibody||1.404|1.219|
70922819|NCT04950127|141336686|SUPERIORITY|Social|Mean Difference (Net)|-0.15||||0.836|TWO_SIDED|95.0|-1.57|1.27||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.||1.27|-1.57|0.836
70985291|NCT00958568|141479798|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.004
70985292|NCT00958568|141479799|SUPERIORITY_OR_OTHER|||||||1||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||1.00
70985293|NCT00958568|141479800|SUPERIORITY_OR_OTHER||LS Mean Difference|13.27|STANDARD_ERROR_OF_MEAN|7.62||0.083|TWO_SIDED|95.0|-1.72|28.26||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||28.26|-1.72|0.083
70985294|NCT00958568|141479801|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value is for Borderline to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.029
70985295|NCT00958568|141479801|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||P-value is for Normal to Borderline. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.014
70985296|NCT00958568|141479801|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||P-value is for Normal to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.054
70985297|NCT00958568|141479802|SUPERIORITY_OR_OTHER||LS Mean Difference|5.89|STANDARD_ERROR_OF_MEAN|1.87||0.002|TWO_SIDED|95.0|2.22|9.56||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||9.56|2.22|0.002
71037608|NCT02554877|141582193|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.3|STANDARD_ERROR_OF_MEAN|0.26||0.2391|TWO_SIDED|90.0|-0.12|0.73||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation. (Excluding outliers)||0.73|-0.12|0.2391
71037609|NCT02554877|141582193|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.9912|TWO_SIDED|90.0|-0.42|0.43||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation. (Excluding outliers)||0.43|-0.42|0.9912
71037610|NCT02554877|141582193|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.34|STANDARD_ERROR_OF_MEAN|0.26||0.193|TWO_SIDED|90.0|-0.09|0.77||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation. (Excluding outliers)||0.77|-0.09|0.1930
71037611|NCT02554877|141582193|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.8|STANDARD_ERROR_OF_MEAN|0.27||0.0038|TWO_SIDED|90.0|0.35|1.25||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation. (Excluding outliers)||1.25|0.35|0.0038
71037612|NCT02554877|141582193|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.57|STANDARD_ERROR_OF_MEAN|0.27||0.0394|TWO_SIDED|90.0|0.12|1.02||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||1.02|0.12|0.0394
71037613|NCT02554877|141582193|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.48|STANDARD_ERROR_OF_MEAN|0.28||0.0862|TWO_SIDED|90.0|0.02|0.93||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||0.93|0.02|0.0862
71037614|NCT02554877|141582193|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.05|STANDARD_ERROR_OF_MEAN|0.34||0.0024|TWO_SIDED|90.0|0.48|1.61||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||1.61|0.48|0.0024
71097813|NCT06097273|141704111|NON_INFERIORITY|The noninferiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.308|||||TWO_SIDED|97.5|1.207|1.418||||||GMR (Cohort B1 vs Cohort B2) for SARS-CoV-2 Antibody||1.418|1.207|
71097814|NCT06097273|141704112|SUPERIORITY|The superiority in seroconversion rate (SCR) in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|5.4|||||TWO_SIDED|95.0|2.4|8.4||||||Percentage Difference (Cohort A1 vs Cohort A2) for Influenza A H1N1 Antibody||8.4|2.4|
71097815|NCT06097273|141704112|NON_INFERIORITY|The noninferiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|5.4|||||TWO_SIDED|97.5|1.9|8.8||||||Percentage Difference (Cohort A1 vs Cohort A2) for Influenza A H1N1 Antibody||8.8|1.9|
70985298|NCT00958568|141479803|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||P-value is for Impaired to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.031
70985299|NCT00958568|141479803|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for Normal to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||1.00
70985300|NCT00958568|141479803|SUPERIORITY_OR_OTHER|||||||0.344||95.0||||P-value is for Normal to Impaired. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.344
70985301|NCT00958568|141479803|SUPERIORITY_OR_OTHER|||||||0.072||95.0||||P-value is for Normal/Impaired to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.072
70985302|NCT00958568|141479804|SUPERIORITY_OR_OTHER||LS Mean Difference|3.92|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|2.96|4.88||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||4.88|2.96|<0.001
70985303|NCT00958568|141479805|SUPERIORITY_OR_OTHER||||||<|0.001||||||The threshold for statistical significance was 0.05.|Fisher Exact|||||||<0.001
70985304|NCT00958568|141479806|SUPERIORITY_OR_OTHER|||||||0.392||95.0||||P-value is for suicidal ideation. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.392
70985305|NCT00958568|141479807|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.57|STANDARD_ERROR_OF_MEAN|1.95||0.421|TWO_SIDED|95.0|-5.42|2.27||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||2.27|-5.42|0.421
70985306|NCT01591018|141479816|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||Pre-study calculations using chi-square test with a continuity correction showed that ≥60 patients in each group were needed to reach a significant difference with an alpha value of 0.05 (two-tailed) and a beta value of 0.8.|Chi-squared, Corrected|||Sample size was based on an expected 20% reduction of new ischemic lesions on DW-MRI in the sonolysis group (estimated prevalence, 10%) compared with the control group (estimated prevalence, 30%).||||<0.05
70985307|NCT02677701|141479832|SUPERIORITY||Mean Difference (Net)|3.44||||0.0846|TWO_SIDED|95.0|-0.48|7.35|||Regression, Linear|Adjusted for baseline: ppFEV1 (25%-50%, \>50%-75%, \>75%), azithromycin use (current vs. non-current), inhaled tobramycin type (powder vs. solution).||||7.35|-0.48|0.0846
70985308|NCT02677701|141479833|SUPERIORITY||Mean Difference (Net)|1.31||||0.51|TWO_SIDED|95.0|-2.64|5.26|||Regression, Linear|Adjusted for baseline: ppFEV1 (25%-50%, \>50%-75%, \>75%), azithromycin use (current vs. non-current), inhaled tobramycin type (powder vs. solution).||||5.26|-2.64|0.51
70985309|NCT02677701|141479834|SUPERIORITY||Mean Difference (Net)|-2.89||||0.17|TWO_SIDED|95.0|-7.01|1.22|||Regression, Linear|Adjusted for baseline: ppFEV1 (25%-50%, \>50%-75%, \>75%), azithromycin use (current vs. non-current), inhaled tobramycin type (powder vs. solution).||||1.22|-7.01|0.17
70985310|NCT02677701|141479835|SUPERIORITY||Mean Difference (Net)|1.53||||0.56|TWO_SIDED|95.0|-3.7|6.77||Adjusted for baseline: ppFEV1 (25%-50%, \>50%-75%, \>75%), azithromycin use (current vs. non-current), inhaled tobramycin type (powder vs. solution).|Regression, Linear|||||6.77|-3.70|0.56
70985311|NCT02677701|141479836|SUPERIORITY||Mean Difference (Net)|0.75||||0.043|TWO_SIDED|95.0|0.03|1.47||Adjusted for baseline: ppFEV1 (25%-50%, \>50%-75%, \>75%), azithromycin use (current vs. non-current), inhaled tobramycin type (powder vs. solution).|Regression, Linear|||||1.47|0.03|0.043
70985312|NCT00909090|141479873|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
70985313|NCT00909090|141479874|SUPERIORITY|||||||0.21|||||||Regression, Linear|||Analysis compared mean differences between placebo and intervention at the 12-month time point.||||0.21
70985314|NCT00909090|141479875|SUPERIORITY|||||||0.01|||||||t-test, 1 sided|||Analysis compared mean change from baseline to 12-month time points.||||0.01
70985315|NCT00909090|141479876|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||analysis conducted on mean change over one year, between groups||||0.02
70985316|NCT02345434|141479879|SUPERIORITY||Mean Difference (Final Values)|3.53|||||TWO_SIDED|95.0|-6.35|13.4||||||||13.4|-6.35|
70985317|NCT02345434|141479880|SUPERIORITY||Mean Difference (Final Values)|-0.79|||||TWO_SIDED|95.0|-3.68|2.1||||||||2.1|-3.68|
70985318|NCT00062738|141479885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.7|||<|0.05|TWO_SIDED|95.0|0.8|15.9|||Fisher Exact|||For the responder analysis, an LOCF approach was used in which a clinical response was operationally defined as at least a 50% reduction in the HAM-D score from baseline to 8 weeks. Clinical response was cross-tabulated with treatment and Fisher exact test was used to distinguish differences among these groups.||15.9|0.8|<.05
70985319|NCT01214434|141479891|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Chi-squared|||||||>0.05
70985320|NCT01214434|141479893|SUPERIORITY_OR_OTHER||||||=|0.03||95.0|||||t-test, 2 sided|||||||=0.03
70985321|NCT01214434|141479894|SUPERIORITY_OR_OTHER||||||=|0.6||95.0|||||t-test, 2 sided|||||||=0.6
70985322|NCT01214434|141479895|SUPERIORITY_OR_OTHER||||||=|0.24||95.0|||||t-test, 2 sided|||||||=.24
70985323|NCT01214434|141479896|SUPERIORITY_OR_OTHER||||||=|0.8||95.0|||||t-test, 2 sided|||||||=0.8
70985324|NCT03494725|141479936|SUPERIORITY|||||||0.757||||||Outcome was subjected to transformation to meet model assumptions. The threshold for statistical significance was p=0.05.|Mixed Models Analysis|Linear mixed model||The sample size was computed for a repeated measurement ANOVA with two groups and seven repeated measurements (power=0.85, α=0.05, f=0.1). The calculation resulted in a group size of 56 participants each, which was rounded up to 60 participants per treatment group to account for attrition.||||0.757
70985325|NCT00514449|141479977|OTHER||number of voxels in a cluster|2037.0||||0.004|TWO_SIDED|||||p value is adjusted for multiple comparisons|ANCOVA||Time by treatment group interaction term|||||0.004
70985326|NCT00149825|141479986|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||Chi-squared|This is a one-tailed test||We hypothesized that compared with MED+CTRL, a greater percent of participants randomized to MED+CBTI will experience remission of depression||||.13
70985327|NCT00149825|141479987|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||We hypothesized that compared with MED+CTRL, a greater percent of participants in MED+CBTI will experience remission of insomnia.||||.05
70985328|NCT00942708|141479989|OTHER|Single group evaluation of change in PVR between 12 weeks and baseline (T-test for one group, 2-sided, p\<0.05 considered significant)||||||0.09|||||||t-test, 1 sided|||||||0.09
70985329|NCT02760407|141479992|SUPERIORITY||Risk Difference (RD)|0.27|||<|0.0001|TWO_SIDED|97.5|0.183|0.352|||Chi-squared|2x2 chi-square test||The OKZ ACR20 response rate for the 64 mg q4w treatment group at Week 12 was expected to be at least 50% resulting in an expected difference in ACR20 response rates of 25 percentage points between the respective OKZ treatment group and placebo. Sample size yield 100% disjunctive power for testing the primary hypothesis||0.352|0.183|<0.0001
70985330|NCT02760407|141479992|SUPERIORITY||Risk Difference (RD)|0.258|||<|0.0001|TWO_SIDED|97.5|0.171|0.341|||Chi-squared|2x2 chi-square test||The OKZ ACR20 response rate for the 64 mg q2w treatment group at Week 12 was expected to be at least 55%, resulting in an expected difference in ACR20 response rate of 30 percentage points between the respective OKZ treatment group and placebo. Sample size yield 100% disjunctive power for testing the primary hypothesis||0.341|0.171|<0.0001
70985331|NCT02760407|141479993|SUPERIORITY||Risk Difference (RD)|0.224|||<|0.0001|TWO_SIDED|95.0|0.148|0.298|||Chi-squared|2x2 chi-square test||The ACR20 response rate for adalimumab was expected to be at least 52.5% at Week 12.||0.298|0.148|<0.0001
70985332|NCT02760407|141479993|NON_INFERIORITY|Non-Inferiority for each OKZ dosing regimen versus Adalimumab is achieved if the lower limit of the 97.5% confidence interval is greater than the protocol defined non-inferiority margin of -12%.|Risk Difference (RD)|0.045|||||TWO_SIDED|97.5|-0.022|0.112||||||A noninferiority margin of 12% was used for the comparison between OKZ and adalimumab with respect to this endpoint.||0.112|-0.022|
70985333|NCT02760407|141479993|NON_INFERIORITY|Non-Inferiority for each OKZ dosing regimen versus Adalimumab is achieved if the lower limit of the 97.5% confidence interval is greater than the protocol defined non-inferiority margin of -12%.|Risk Difference (RD)|0.034|||||TWO_SIDED|97.5|-0.035|0.102||||||A noninferiority margin of 12% was used for the comparison between OKZ and adalimumab with respect to this endpoint.||0.102|-0.035|
70985334|NCT02760407|141479994|SUPERIORITY||Risk Difference (RD)|0.332|||<|0.0001|TWO_SIDED|97.5|0.257|0.397|||Chi-squared|2x2 chi-square test||The DAS28 low disease activity (based on DAS28 \[CRP\] \<3.2) response rate at Week 12 is estimated to be 10% in the placebo group and 22% in the 64 mg q4w OKZ group, resulting in an expected difference of 12 percentage points between respective OKZ group and placebo.||0.397|0.257|<0.0001
70985335|NCT02760407|141479994|SUPERIORITY||Risk Difference (RD)|0.325|||<|0.0001|TWO_SIDED|97.5|0.25|0.391|||Chi-squared|2x2 chi-square test||The DAS28 low disease activity (based on DAS28 \[CRP\] \<3.2) response rate at Week 12 is estimated to be 10% in the placebo group and 30% in the 64 mg q2w OKZ group, resulting in an expected difference of 20 percentage points between respective OKZ group and placebo.||0.391|0.250|<0.0001
70985336|NCT02760407|141479995|SUPERIORITY||Risk Difference (RD)|0.256|||<|0.0001|TWO_SIDED|95.0|0.191|0.313|||Chi-squared|2x2 chi-square test||The DAS28 low disease activity response rate for adalimumab was expected to be at least 27% at Week 12.||0.313|0.191|<0.0001
70985337|NCT02760407|141479995|NON_INFERIORITY|Non-Inferiority for each OKZ dosing regimen versus Adalimumab is achieved if the lower limit of the 97.5% confidence interval is greater than the protocol defined noninferiority margin of -7.5%.|Risk Difference (RD)|0.076|||||TWO_SIDED|97.5|0.004|0.147||||||A noninferiority margin of 7.5% was used for the comparison between OKZ and adalimumab with respect to this endpoint.||0.147|0.004|
70985338|NCT02760407|141479995|NON_INFERIORITY|Non-Inferiority for each OKZ dosing regimen versus Adalimumab is achieved if the lower limit of the 97.5% confidence interval is greater than the protocol defined noninferiority margin of -7.5%.|Risk Difference (RD)|0.069|||||TWO_SIDED|97.5|-0.003|0.141||||||A noninferiority margin of 7.5% was used for the comparison between OKZ and adalimumab with respect to this endpoint.||0.141|-0.003|
70985339|NCT02760407|141479996|SUPERIORITY||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.046|<|0.0001|TWO_SIDED|97.5|-0.29|-0.09|||ANCOVA|||||-0.09|-0.29|<0.0001
70985340|NCT02760407|141479996|SUPERIORITY||Least Squares Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.046|<|0.0001|TWO_SIDED|97.5|-0.33|-0.12|||ANCOVA|||||-0.12|-0.33|<0.0001
70985341|NCT02760407|141479996|OTHER||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.046|||TWO_SIDED|95.0|-0.28|-0.1||||||||-0.10|-0.28|
70985342|NCT02760407|141479997|SUPERIORITY||Risk Difference (RD)|0.275|||<|0.0001|TWO_SIDED|97.5|0.192|0.349|||Chi-squared|2x2 chi-square test||||0.349|0.192|<0.0001
71037615|NCT02554877|141582193|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.92|STANDARD_ERROR_OF_MEAN|0.34||0.0068|TWO_SIDED|90.0|0.37|1.48||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||1.48|0.37|0.0068
71037616|NCT02554877|141582193|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.86|STANDARD_ERROR_OF_MEAN|0.34||0.0132|TWO_SIDED|90.0|0.29|1.42||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||1.42|0.29|0.0132
71097816|NCT06097273|141704112|SUPERIORITY|The superiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|4.0|||||TWO_SIDED|95.0|1.0|7.1||||||Percentage Difference (Cohort A1 vs Cohort A2) for Influenza A H3N2 Antibody||7.1|1.0|
70985343|NCT02760407|141479997|SUPERIORITY||Risk Difference (RD)|0.278|||<|0.0001|TWO_SIDED|97.5|0.195|0.353|||Chi-squared|2x2 chi-square test||||0.353|0.195|<0.0001
70985344|NCT02760407|141479997|OTHER||Risk Difference (RD)|0.237|||||TWO_SIDED|95.0|0.165|0.303||||||||0.303|0.165|
70985345|NCT02760407|141479998|SUPERIORITY||Risk Difference (RD)|0.08||||0.0003|TWO_SIDED|97.5|0.031|0.123|||Chi-squared|2x2 chi-square test||||0.123|0.031|0.0003
70985346|NCT02760407|141479998|SUPERIORITY||Risk Difference (RD)|0.069||||0.001|TWO_SIDED|97.5|0.02|0.111|||Chi-squared|2x2 chi-square test||||0.111|0.020|0.001
70985347|NCT02760407|141479998|OTHER||Risk Difference (RD)|0.089|||||TWO_SIDED|95.0|0.046|0.127||||||||0.127|0.046|
70985348|NCT03245814|141480011|SUPERIORITY||Odds Ratio (OR)|0.22|||<|0.001|TWO_SIDED|95.0|0.12|0.42|||Ordinal cumulative probability model|Covariates included baseline score \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.42|0.12|<.001
70985349|NCT03245814|141480012|SUPERIORITY||Odds Ratio (OR)|0.21|||<|0.001|TWO_SIDED|95.0|0.11|0.4|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.40|0.11|<.001
70985350|NCT03245814|141480013|SUPERIORITY||Odds Ratio (OR)|0.45||||0.02|TWO_SIDED|95.0|0.23|0.86|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.86|0.23|.02
70985351|NCT03245814|141480014|SUPERIORITY||Odds Ratio (OR)|0.25|||<|0.001|TWO_SIDED|95.0|0.13|0.5|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.50|0.13|<.001
70985352|NCT03245814|141480015|SUPERIORITY||Odds Ratio (OR)|0.34||||0.001|TWO_SIDED|95.0|0.18|0.64|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.64|0.18|.001
70985353|NCT03245814|141480016|SUPERIORITY||Odds Ratio (OR)|2.83||||0.003|TWO_SIDED|95.0|1.47|5.45|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||5.45|1.47|.003
70985354|NCT03245814|141480017|SUPERIORITY||Odds Ratio (OR)|0.24|||<|0.001|TWO_SIDED|95.0|0.12|0.48|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.48|0.12|<.001
70985355|NCT03245814|141480018|SUPERIORITY||Odds Ratio (OR)|3.84|||<|0.001|TWO_SIDED|95.0|2.0|7.38|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||7.38|2.00|<.001
70985356|NCT03245814|141480019|SUPERIORITY||Odds Ratio (OR)|4.49|||<|0.001|TWO_SIDED|95.0|2.28|8.83|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||8.83|2.28|<.001
71037617|NCT02554877|141582193|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.39|STANDARD_ERROR_OF_MEAN|0.45||0.0024|TWO_SIDED|90.0|0.65|2.14||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||2.14|0.65|0.0024
71037618|NCT02554877|141582193|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.15|STANDARD_ERROR_OF_MEAN|0.45||0.0115|TWO_SIDED|90.0|0.4|1.89||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||1.89|0.40|0.0115
71037619|NCT02554877|141582193|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.97|STANDARD_ERROR_OF_MEAN|0.45||0.0344|TWO_SIDED|90.0|0.22|1.72||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||1.72|0.22|0.0344
71037620|NCT04547192|141582206|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|1.54||||0.504|TWO_SIDED|||||Adjusted for TIF introduction and time periods as fixed effects and hospitals and time periods as random effects.|generalized linear mixed regression mode|||For mobility on EU arrival assessed,||||0.504
71097817|NCT06097273|141704112|NON_INFERIORITY|The noninferiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|4.0|||||TWO_SIDED|97.5|0.5|7.6||||||Percentage Difference (Cohort A1 vs Cohort A2) for Influenza A H3N2 Antibody||7.6|0.5|
70985357|NCT03245814|141480020|SUPERIORITY||Odds Ratio (OR)|3.73|||<|0.001|TWO_SIDED|95.0|1.88|7.4|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||7.40|1.88|<.001
71097818|NCT06097273|141704112|SUPERIORITY|The superiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|4.5|||||TWO_SIDED|95.0|1.9|7.2||||||Percentage Difference (Cohort A1 vs Cohort A2) for Victoria-lineage Antibody||7.2|1.9|
70985358|NCT03245814|141480021|SUPERIORITY||Odds Ratio (OR)|2.33||||0.02|TWO_SIDED|95.0|1.22|4.47|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||4.47|1.22|.02
70985359|NCT03245814|141480022|SUPERIORITY||Odds Ratio (OR)|0.39||||0.009|TWO_SIDED|95.0|0.2|0.75|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.75|0.20|.009
71097819|NCT06097273|141704112|NON_INFERIORITY|The noninferiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|4.5|||||TWO_SIDED|95.0|1.5|7.5||||||Percentage Difference (Cohort A1 vs Cohort A2) for Victoria-lineage Antibody||7.5|1.5|
70985360|NCT03245814|141480023|SUPERIORITY||Slope|0.42|STANDARD_ERROR_OF_MEAN|0.14||0.002|TWO_SIDED||||||Mixed Models Analysis|Mixed effects regression models to account for repeated measures (multiple assessments per day) within individuals.||||||0.002
70985361|NCT01158950|141480031|SUPERIORITY|||||||0.032||||||The threshold for statistical significance was set to p \< 0.05.|Fisher transformation|||The comparison group represents the difference in ICR and the baseline impulsiveness scale.||||0.032
70985362|NCT01158950|141480032|SUPERIORITY||||||<|0.05||||||The threshold is set to p \< 0.05, corrected for multiple comparisons.|Fisher transformation|Statistical tests are computed across multiple subregions (voxels) within each area. Thus, the correlation coefficient above is a summary score.||||||< 0.05
70985363|NCT03320512|141480103|SUPERIORITY||Average Treatment Effect|0.15||||0.04965|TWO_SIDED|95.0|0.0|0.29|||TMLE estimation of ATE and Wald test|Targeted Maximum Likelihood Estimation (TMLE) Average Treatment Effect (ATE)||Month 3 The analysis includes the intent-to-treat population||0.29|0.00|0.04965
70985364|NCT03320512|141480103|SUPERIORITY||Average Treatment Effect|-0.04||||0.62|TWO_SIDED|95.0|-0.21|0.13|||TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population||0.13|-0.21|0.62
70985365|NCT03320512|141480104|SUPERIORITY||Average Treatment Effect|0.12||||0.11|TWO_SIDED|95.0|-0.03|0.26|||TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population||0.26|-0.03|0.11
70985366|NCT03320512|141480104|SUPERIORITY||Average Treatment Effect|0.06||||0.38|TWO_SIDED|95.0|-0.08|0.21|||TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population||0.21|-0.08|0.38
70985367|NCT03320512|141480105|SUPERIORITY||Average Treatment Effect|0.04||||0.68|TWO_SIDED|95.0|-0.09|0.16||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.16|-0.09|0.68
71097820|NCT06097273|141704112|SUPERIORITY|The superiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|-1.4|||||TWO_SIDED|95.0|-3.3|0.4||||||Percentage Difference (Cohort A1 vs Cohort A2) for Yamagata-lineage Antibody||0.4|-3.3|
71097821|NCT06097273|141704112|NON_INFERIORITY|The noninferiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|-1.4|||||TWO_SIDED|97.5|-3.6|0.7||||||Percentage Difference (Cohort A1 vs Cohort A2) for Yamagata-lineage Antibody||0.7|-3.6|
71097822|NCT06097273|141704112|SUPERIORITY|The superiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|17.9|||||TWO_SIDED|95.0|14.8|21.0||||||Percentage Difference (Cohort B1 vs Cohort B2) for Influenza A H1N1 Antibody||21.0|14.8|
71097823|NCT06097273|141704112|NON_INFERIORITY|The noninferiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|17.9|||||TWO_SIDED|97.5|14.3|21.4||||||Percentage Difference (Cohort B1 vs Cohort B2) for Influenza A H1N1 Antibody||21.4|14.3|
70922820|NCT04950127|141336686|SUPERIORITY|Symptoms|Mean Difference (Net)|0.45||||0.318|TWO_SIDED|95.0|-0.44|1.34||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.||1.34|-0.44|0.318
70922821|NCT04950127|141336687|SUPERIORITY||Mean Difference (Net)|-0.37|||<|0.001|TWO_SIDED|95.0|-0.55|-0.2||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PGI-S score, Visit\*Baseline PGI-S score interaction, Baseline Concomitant Itch Medication.||-0.20|-0.55|<0.001
70985368|NCT03320512|141480105|SUPERIORITY||Average Treatment Effect|0.11||||0.53|TWO_SIDED|95.0|-0.03|0.25||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.25|-0.03|0.53
70985369|NCT03320512|141480106|SUPERIORITY||Average Treatment Effect|0.06||||0.53|TWO_SIDED|95.0|-0.02|0.15||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.15|-0.02|0.53
70985370|NCT03320512|141480106|SUPERIORITY||Average Treatment Effect|0.0||||0.96|TWO_SIDED|95.0|-0.12|0.12||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.12|-0.12|0.96
70985371|NCT03320512|141480107|SUPERIORITY||Average Treatment Effect|0.08||||0.93|TWO_SIDED|95.0|-0.84|1.0||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||1.00|-0.84|0.93
70985372|NCT03320512|141480107|SUPERIORITY||Average Treatment Effect|-1.12||||0.6|TWO_SIDED|95.0|-4.16|1.91||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||1.91|-4.16|0.60
70985373|NCT03320512|141480108|SUPERIORITY||Average Treatment Effect|0.73||||0.6|TWO_SIDED|95.0|-1.03|2.48||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||2.48|-1.03|0.60
71037621|NCT04547192|141582206|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|2.31||||0.169|TWO_SIDED||||||generalized linear mixed regression mode|||Respiratory rate at EU assessed||||0.169
71037622|NCT04547192|141582206|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|25.29||||0.006|TWO_SIDED||||||generalized linear mixed regression|||Airway assessed||||0.006
71097824|NCT06097273|141704112|SUPERIORITY|The superiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|14.6|||||TWO_SIDED|95.0|11.6|17.6||||||Percentage Difference (Cohort B1 vs Cohort B2) for Influenza A H3N2 Antibody||17.6|11.6|
71097825|NCT06097273|141704112|NON_INFERIORITY|The noninferiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|14.6|||||TWO_SIDED|97.5|11.1|18.0||||||Percentage Difference (Cohort B1 vs Cohort B2) for Influenza A H3N2 Antibody||18.0|11.1|
71097826|NCT06097273|141704112|SUPERIORITY|The superiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|8.6|||||TWO_SIDED|95.0|6.0|11.2||||||Percentage Difference (Cohort B1 vs Cohort B2) for Victoria-lineage Antibody||11.2|6.0|
71097827|NCT06097273|141704112|NON_INFERIORITY|The noninferiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|8.6|||||TWO_SIDED|97.5|5.6|11.6||||||Percentage Difference (Cohort B1 vs Cohort B2) for Victoria-lineage Antibody||11.6|5.6|
71097828|NCT06097273|141704112|SUPERIORITY|The superiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|2.7|||||TWO_SIDED|95.0|0.6|4.7||||||Percentage Difference (Cohort B1 vs Cohort B2) for Yamagata-lineage Antibody||4.7|0.6|
71097829|NCT06097273|141704112|NON_INFERIORITY|The noninferiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|2.7|||||TWO_SIDED|97.5|0.3|5.0||||||Percentage Difference (Cohort B1 vs Cohort B2) for Yamagata-lineage Antibody||5.0|0.3|
71097830|NCT06097273|141704113|SUPERIORITY|The superiority in seroresponse rate (SRR) in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the SRR difference was \>0%.|Percentage Difference|12.8|||||TWO_SIDED|95.0|10.0|15.5||||||Percentage Difference (Cohort A1 vs Cohort A2) for SARS-CoV-2 Antibody||15.5|10.0|
71097831|NCT06097273|141704113|NON_INFERIORITY|The noninferiority in SRR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the SRR difference was \>-10%.|Percentage Difference|12.8|||||TWO_SIDED|97.5|9.6|15.9||||||Percentage Difference (Cohort A1 vs Cohort A2) for SARS-CoV-2 Antibody||15.9|9.6|
71097832|NCT06097273|141704113|SUPERIORITY|The superiority in SRR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the SRR difference was \>0%.|Percentage Difference|8.1|||||TWO_SIDED|95.0|5.5|10.6||||||Percentage Difference (Cohort B1 vs Cohort B2) for SARS-CoV-2 Antibody||10.6|5.5|
71037623|NCT04547192|141582206|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|38.38||||0.001|TWO_SIDED||||||generalized linear mixed regression|||Chest examined||||0.001
71037624|NCT04547192|141582206|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|93.01||||0.001|TWO_SIDED||||||generalized linear mixed regression|||For Intra-abdominal bleeding evaluated||||0.001
71037625|NCT04547192|141582206|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|354.91||||0.001|TWO_SIDED||||||generalized linear mixed regression|||For Spine Immobilized for RTI or Fall Victims||||0.001
71037626|NCT04547192|141582206|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|4.95||||0.001|TWO_SIDED||||||generalized linear mixed regression|||Splinting of Fractures Considered||||0.001
71037627|NCT04547192|141582206|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|5.18||||0.006|TWO_SIDED||||||generalized linear mixed regression|||Tetanus Considered for bites, burns, lacerations, and abrasions||||0.006
71097833|NCT06097273|141704113|NON_INFERIORITY|The noninferiority in SRR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the SRR difference was \>-10%.|Percentage Difference|8.1|||||TWO_SIDED|97.5|5.2|11.0||||||Percentage Difference (Cohort B1 vs Cohort B2) for SARS-CoV-2 Antibody||11.0|5.2|
70985374|NCT03320512|141480108|SUPERIORITY||Average Treatment Effect|-0.91||||0.6|TWO_SIDED|95.0|-2.86|1.04||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||1.04|-2.86|0.60
70985375|NCT03320512|141480109|SUPERIORITY||Average Treatment Effect|-0.06||||0.6|TWO_SIDED|95.0|-0.2|0.08||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 Gonorrhea The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.08|-0.20|0.60
70985376|NCT03320512|141480109|SUPERIORITY||Average Treatment Effect|-0.06||||0.6|TWO_SIDED|95.0|-0.21|0.09||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 Gonorrhea The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.09|-0.21|0.60
70985377|NCT03320512|141480109|SUPERIORITY||Average Treatment Effect|-0.13||||0.53|TWO_SIDED|95.0|-0.3|0.03||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 Chlamydia The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.03|-0.30|0.53
70985378|NCT03320512|141480109|SUPERIORITY||Average Treatment Effect|-0.08||||0.6|TWO_SIDED|95.0|-0.24|0.08||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 Chlamydia The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.08|-0.24|0.60
70985379|NCT03320512|141480109|SUPERIORITY||Average Treatment Effect|-0.11||||0.53|TWO_SIDED|95.0|-0.25|0.04||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 Syphillis The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.04|-0.25|0.53
70985380|NCT03320512|141480109|SUPERIORITY||Average Treatment Effect|-0.07||||0.6|TWO_SIDED|95.0|-0.2|0.07||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 Syphillis The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.07|-0.20|0.60
70985381|NCT03320512|141480110|SUPERIORITY||Average Treatment Effect|0.11|||||TWO_SIDED|95.0|-0.07|0.29|||||TMLE estimation of ATE and Wald Confidence Interval|Month 3 The analysis includes the intent-to-treat population and compares P3 vs. Control.||0.29|-0.07|
70985382|NCT03320512|141480110|SUPERIORITY||Average Treatment Effect|0.19|||||TWO_SIDED|95.0|0.03|0.34|||||TMLE estimation of ATE and Wald Confidence Interval|Month 3 The analysis includes the intent-to-treat population and compares P3+ vs. Control.||0.34|0.03|
71097834|NCT05894564|141704124|SUPERIORITY|Posterior probability of efficacy (P(HR\>1))|Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.88|1.1|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.10|0.88|
70985383|NCT03320512|141480110|SUPERIORITY||Average Treatment Effect|-0.06|||||TWO_SIDED|95.0|-0.27|0.15|||||TMLE estimation of ATE and Wald Confidence Interval|Month 6 The analysis includes the intent-to-treat population and compares P3 vs. Control.||0.15|-0.27|
70985384|NCT03320512|141480110|SUPERIORITY||Average Treatment Effect|-0.02|||||TWO_SIDED|95.0|-0.21|0.16|||||TMLE estimation of ATE and Wald Confidence Interval|Month 6 The analysis includes the intent-to-treat population and compares P3+ vs. Control.||0.16|-0.21|
70985385|NCT03320512|141480111|SUPERIORITY||Average Treatment Effect|0.11|||||TWO_SIDED|95.0|-0.05|0.26|||||TMLE estimation of ATE and Wald Confidence Interval|Month 3 The analysis includes the intent-to-treat population and compares P3 vs. Control.||0.26|-0.05|
71097835|NCT05894564|141704125|SUPERIORITY||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.05|5.65|||||Low event rate precluded covariate adjustment.|No hypothesis test or decision rule was evaluated.||5.65|0.05|
70985386|NCT03320512|141480111|SUPERIORITY||Average Treatment Effect|0.13|||||TWO_SIDED|95.0|-0.04|0.29|||||TMLE estimation of ATE and Wald Confidence Interval|Month 3 The analysis includes the intent-to-treat population and compares P3+ vs. Control.||0.29|-0.04|
71097836|NCT05894564|141704128|SUPERIORITY|Posterior probability of efficacy (P(HR\<1))|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.31|1.28|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.28|0.31|
71097837|NCT05894564|141704129|SUPERIORITY||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.56|1.87|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.87|0.56|
71097838|NCT05894564|141704130|SUPERIORITY||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.25|1.16|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.16|0.25|
71097839|NCT05894564|141704131|SUPERIORITY||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.33|1.74|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.74|0.33|
71097840|NCT05894564|141704132|OTHER||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.71|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.21|0.71|
71097841|NCT05894564|141704132|OTHER||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.67|1.19|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.19|0.67|
71097842|NCT05894564|141704132|OTHER||Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.61|1.19|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.19|0.61|
71097843|NCT05894564|141704132|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.61|1.28|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.28|0.61|
71097844|NCT05894564|141704132|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.7|1.49|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.49|0.70|
70985387|NCT03320512|141480111|SUPERIORITY||Average Treatment Effect|0.09|||||TWO_SIDED|95.0|-0.08|0.26|||||TMLE estimation of ATE and Wald Confidence Interval|Month 6 The analysis includes the intent-to-treat population and compares P3 vs. Control.||0.26|-0.08|
71097845|NCT05894564|141704133|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.8|1.27|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.27|0.80|
71097846|NCT05894564|141704133|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.77|1.26|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.26|0.77|
71097847|NCT05894564|141704133|OTHER||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.67|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.14|0.67|
71097848|NCT05894564|141704133|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.77|1.36|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.36|0.77|
71097849|NCT05894564|141704133|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.76|1.33|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.33|0.76|
71097850|NCT05894564|141704134|OTHER||Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.65|1.09|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.09|0.65|
71097851|NCT05894564|141704134|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.74|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.32|0.74|
71097852|NCT05894564|141704134|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.64|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.21|0.64|
71097853|NCT05894564|141704134|OTHER||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.87|1.73|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.73|0.87|
70985388|NCT03320512|141480111|SUPERIORITY||Average Treatment Effect|0.03|||||TWO_SIDED|95.0|-0.13|0.19|||||TMLE estimation of ATE and Wald Confidence Interval|Month 6 The analysis includes the intent-to-treat population and compares P3+ vs. Control.||0.19|-0.13|
70985389|NCT03320512|141480112|SUPERIORITY||Average Treatment Effect|0.09||||0.11|TWO_SIDED|95.0|-0.02|0.19|||TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.19|-0.02|0.11
70985390|NCT03320512|141480112|SUPERIORITY||Average Treatment Effect|-0.01||||0.82|TWO_SIDED|95.0|-0.14|0.11|||TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.11|-0.14|0.82
70985391|NCT03320512|141480113|SUPERIORITY||Average Treatment Effect|8.95||||0.05|TWO_SIDED|95.0|0.07|17.83||The a priori threshold for statistical significance is 0.025.|TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||17.83|0.07|0.05
70985392|NCT03320512|141480113|SUPERIORITY||Average Treatment Effect|-3.69||||0.45|TWO_SIDED|95.0|-13.33|5.95|||TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||5.95|-13.33|0.45
70985393|NCT03320512|141480114|SUPERIORITY||Incremental cost effectiveness ratio|25.79|||||TWO_SIDED|95.0|-194.05|236.81|||||The confidence interval was created using percentile bootstrap.|Participants were included if they were at an active site with cost data and had a 3-month binary TFV measure.||236.81|-194.05|
70985394|NCT00638846|141480115|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.739|||||TWO_SIDED|97.4|1.136|1.739|||Generalized Linear Model||Odds ratio was senofilcon A toric / balafilcon A toric|Alternative hypothesis is senofilcon A toric is superior to balfilcon A toric by having less degrees of rotation||1.739|1.136|
70985395|NCT00638846|141480116|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.138|||||TWO_SIDED|97.4|0.624|1.138|||Generalized Linear Model||Odds ratio was senofilcon A toric/balafilcon A toric|Alternative hypothesis is that senofilcon A toric is superior to balafilcon A toric by having less degrees of instability.||1.138|0.624|
70985396|NCT00638846|141480117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1307|STANDARD_ERROR_OF_MEAN|0.2856|||TWO_SIDED|97.5|-1.1307|-0.568|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus balafilcon At toric.|Alternative hypothesis is that senofilcon A toric is superior to balafilcon A toric by having less time required to fit.||-0.5680|-1.1307|
70985397|NCT00638846|141480118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.368|STANDARD_ERROR_OF_MEAN|0.1331|||TWO_SIDED|97.4|0.07001|0.368|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus balafilcon A toric.|Alternative hypothesis is that senofilcon A is superior to balafilcon A.||0.3680|0.07001|
70985398|NCT00638846|141480119|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is -0.4.|Mean Difference (Final Values)|-0.0688|STANDARD_ERROR_OF_MEAN|0.1648|||TWO_SIDED|97.5|-0.0688|-0.0197|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus balafilcon A toric.|Alternative hypothesis is that senofilcon A toric is superior to balafilcon A toric by having a lower grade fo corneal staining.||-0.0197|-0.0688|
70985399|NCT00638846|141480120|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.368|STANDARD_ERROR_OF_MEAN|0.1331|||TWO_SIDED|97.4|0.07001|0.368|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus balafilcon A toric.|Alternative hypothesis is that senofilcon A toric is superior to balafilcon A toric.||0.3680|0.07001|
70985400|NCT00945750|141480183|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the AUC geometric mean ratio (famotidine CT without water/famotidine FCT with water) is within the hypothesized interval (0.80 and 1.25), then the primary hypothesis of bioequivalence between CT without water and FCT with water is accepted.|Geometric Mean Ratio|1.01||||||90.0|0.94|1.09||||||||1.09|0.94|
70985401|NCT00945750|141480184|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the Cmax geometric mean ratio (famotidine CT without water/famotidine FCT with water) is within the hypothesized interval (0.80 and 1.25), then the primary hypothesis of bioequivalence between CT without water and FCT with water is accepted.|Geometric Mean Ratio|1.03||||||90.0|0.93|1.14||||||||1.14|0.93|
70985402|NCT00945750|141480185|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.11||||||90.0|1.04|1.2||||||||1.20|1.04|
70985403|NCT00945750|141480186|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.12||||||90.0|1.02|1.24||||||||1.24|1.02|
70985404|NCT02531035|141480187|SUPERIORITY||Percentage difference|13.4|||<|0.001|TWO_SIDED|95.0|8.97|17.81||P-values from Cochran-Mantel-Haenszel test stratified by different levels of stratification factors of BMI at Screening(\<25 kg/m\^2,\>=25 kg/m\^2),Week -2 A1C(\<=9.0%, \>9.0%),and using continuous subcutaneous insulin infusion(CSII) at Screening(yes,no).|Cochran-Mantel-Haenszel|||||17.81|8.97|< 0.001
70985405|NCT02531035|141480188|SUPERIORITY||Least Squares Mean Difference|-0.46|||<|0.001|TWO_SIDED|95.0|-0.54|-0.38|||MMRM|||Testing according to hierarchical procedure. Post-Baseline LS means and p-values were obtained from MMRM model with treatment, randomization stratum of BMI at Screening (\<25 kg/m\^2, \>=25 kg/m\^2), randomization stratum of Week -2 A1C (\<=9.0%, \>9.0%), randomization stratum of use of CSII at Screening (yes, no), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline A1C-by-time interaction as a covariate.||-0.38|-0.54|< 0.001
70985406|NCT02531035|141480189|SUPERIORITY||Least squares mean difference|-2.98|||<|0.001|TWO_SIDED|95.0|-3.31|-2.66|||MMRM|||Testing according to hierarchical procedure. Post-Baseline LS means and p-values were obtained from MMRM model with treatment, randomization stratum of BMI at Screening (\<25 kg/m\^2, \>=25 kg/m\^2), randomization stratum of Week -2 A1C (\<=9%, \>9%), randomization stratum of Use of CSII at Screening (Yes, No), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline weight-by-time interaction as a covariate.||-2.66|-3.31|< 0.001
70985407|NCT02531035|141480190|SUPERIORITY||Least Squares Mean Difference|-3.5|||=|0.002|TWO_SIDED|95.0|-5.7|-1.3|||MMRM|||Testing according to the hierarchical procedure. Post-Baseline LS means and p-values were obtained from MMRM model with treatment, randomization stratum of BMI at Screening (\<25 kg/m2, \>=25 kg/m2), randomization stratum of Week -2 A1C (\<=9.0%, \>9.0%), randomization stratum of use of CSII at Screening (yes, no), time (study week), and a treatment-by- time interaction as fixed categorical effects, and Baseline SBP-by-time interaction as a covariate.||-1.3|-5.7|= 0.002
70985408|NCT02531035|141480191|SUPERIORITY||Least squares mean difference|-12.32|||<|0.001|TWO_SIDED|95.0|-18.17|-6.48|||MMRM|||Testing according to hierarchical procedure. Post-Baseline LS means and p-values were obtained from MMRM model with treatment, randomization stratum of BMI at Screening (\<25 kg/m2, \>=25 kg/m2), randomization stratum of Week -2 A1C (\<=9.0%, \>9.0%), randomization stratum of use of CSII at Screening (yes, no), time (study week), a treatment-by-time interaction as fixed categorical effects, and Baseline mean daily bolus insulin dose-by-time interaction as a covariate.||-6.48|-18.17|< 0.001
70985409|NCT03567291|141480228|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.78|TWO_SIDED|95.0|-3.4|2.6|||ANCOVA|||||2.6|-3.4|0.78
70985410|NCT01103349|141480229|SUPERIORITY||Adjusted mean treatment differences|3.87|STANDARD_DEVIATION|1.494||0.005|TWO_SIDED|95.0|0.931|6.809||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||H0: Mean FEV1 % predicted trough change from baseline (BI671800 ED 400 mg bid) ≤ Mean FEV1 % predicted trough change from baseline (placebo)||6.809|0.931|0.0050
70985411|NCT01103349|141480229|SUPERIORITY||Adjusted mean treatment differences|2.369|STANDARD_DEVIATION|1.567||0.0657||95.0|-0.713|5.452||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||H0: Mean FEV1 % predicted trough change from baseline (Montelukast 10 mg qd) ≤ Mean FEV1 % predicted trough change from baseline (placebo)||5.452|-0.713|0.0657
70985412|NCT01103349|141480229|SUPERIORITY||Adjusted mean treatment differences|1.501|STANDARD_DEVIATION|1.602||0.1748|TWO_SIDED|95.0|-1.652|4.653||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||H0: Mean FEV1 % predicted trough change from baseline (BI671800 ED 400 mg bid) ≤ Mean FEV1 % predicted trough change from baseline (Montelukast 10 mg qd)||4.653|-1.652|0.1748
70985413|NCT01103349|141480230|SUPERIORITY||Adjusted mean treatment differences|-0.28|STANDARD_DEVIATION|0.118||0.0092|TWO_SIDED|95.0|-0.512|-0.048||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||-0.048|-0.512|0.0092
70985414|NCT01103349|141480230|SUPERIORITY||Adjusted mean treatment differences|-0.18|STANDARD_DEVIATION|0.124||0.0732|TWO_SIDED|95.0|-0.423|0.063||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.063|-0.423|0.0732
70985415|NCT01103349|141480230|SUPERIORITY||Adjusted mean treatment differences|-0.1|STANDARD_DEVIATION|0.126||0.2139|TWO_SIDED|95.0|-0.347|0.147||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.147|-0.347|0.2139
70985416|NCT00090285|141480231|SUPERIORITY_OR_OTHER||Risk Difference (RD)|90.6||||||95.0|70.1|98.2|||||Confidence Interval (CI) based on binomial tail probabilities and not from a dispersion parameter.|||98.2|70.1|
70985417|NCT00090285|141480239|SUPERIORITY_OR_OTHER||Risk Difference (RD)|77.5||||||95.0|39.6|93.3||||||||93.3|39.6|
70985418|NCT00090285|141480240|SUPERIORITY_OR_OTHER||Risk Difference (RD)|85.5||||||95.0|77.0|91.3|||||CI based on binomial tail probabilities and not from a dispersion parameter. Hochberg multiplicity adjustment applied to the CI.|||91.3|77.0|
71037628|NCT04547192|141582206|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|0.03||||0.047|TWO_SIDED||||||generalized linear mixed regression|||Date of Injury Recorded||||0.047
71037629|NCT04547192|141582206|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|0.42||||0.166|TWO_SIDED||||||generalized linear mixed regression|||Death||||0.166
71037630|NCT04547192|141582206|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|2.14||||0.013|TWO_SIDED||||||generalized linear mixed regression|||Important Clinical Data Document||||0.013
70985419|NCT00090285|141480241|SUPERIORITY_OR_OTHER||Risk Difference (RD)|51.0||||||95.0|40.3|59.9|||||CI based on binomial tail probabilities and not from a dispersion parameter. Hochberg multiplicity adjustment applied to the CI.|||59.9|40.3|
70985420|NCT04498910|141480252|SUPERIORITY||Difference in Estimated change|-1.1|STANDARD_ERROR_OF_MEAN|1.2|||TWO_SIDED|95.0|-3.6|1.2|||Bayesian Mixed Model Analysis|||||1.2|-3.6|
71037631|NCT04547192|141582207|SUPERIORITY||Odds Ratio (OR)|0.42||||0.166|TWO_SIDED||||||generalized linear mixed regression|||||||0.166
71037632|NCT04723693|141582210|OTHER||||||||||||||||||This is a qualitative interview study and as such no statistical analysis was carried out.|||
71037633|NCT04723693|141582211|OTHER||||||||||||||||||This is a qualitative interview study and as such no statistical analysis was carried out.|||
71037634|NCT00538031|141582213|OTHER|||||||0.61|||||||Log Rank|||||||0.61
71037635|NCT00538031|141582214|OTHER|||||||0.95|||||||Log Rank|||||||0.95
71037636|NCT01410227|141582215|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The null hypothesis of the rate of subjects with a treatment success of \<= 0.65 (H0: p \<= 0.65) versus an alternative hypothesis of \> 0.65 (HA: p \> 0.65) was tested at the 5% one-sided level of significance. The proportion of subjects with treatment success under the alternative hypothesis was expected to be approximately 0.90. If 20 subjects were treated, the study provided 86% power to reject the null hypothesis.|Clopper-Pearson|100.0|||||TWO_SIDED|90.0|84.7|100.0|||Clopper-Pearson|||||100|84.7|
71037637|NCT01484912|141582287|NON_INFERIORITY_OR_EQUIVALENCE|The superiority testing was conducted one sided with 0.025 significance level. If H0 was rejected one-sided 0.025 significance level, STA-2 was concluded to be statistically superior to Placebo.All hypothesis testing except for the primary efficacy endpoint was conducted two sides at 0.05 significance level and 95% Confidence Interval (C.I.) was adopted if needed.||||||0.025||95.0|||||t-test, 1 sided|||T-test was used to compare the change in total exercise time between the treatment groups. The change in total exercise time (△) was defined as the total exercise time at end-point visit minus the total exercise time at baseline. Let △T be the change in total exercise time for treatment group (STA-2) and △C be the change in total exercise time for control group (Placebo). The hypothesis testing for the superiority of STA-2 to Placebo was H0：△T-△C≦0 with H1：△T-△C﹥0.||||0.025
71037638|NCT01484912|141582288|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||All hypothesis testing was conducted with T-tests, two sides at 0.05 significance level and 95% Confidence Interval (C.I.) was adopted if needed.||||0.005
71037639|NCT00911274|141582354|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|92.41||||||90.0|82.77|103.18|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.18|82.77|
70985421|NCT04498910|141480253|SUPERIORITY||Difference in Estimated change|-1.5|STANDARD_ERROR_OF_MEAN|1.3|||TWO_SIDED|95.0|-4.2|1.0|||Bayesian Mixed Model Analysis|||||1.0|-4.2|
71037640|NCT00911274|141582355|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|101.3||||||90.0|97.84|104.88|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.88|97.84|
71037641|NCT00911274|141582356|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|97.77|104.34|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.34|97.77|
71097854|NCT05894564|141704134|OTHER||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.85|1.64|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.64|0.85|
70985422|NCT02926573|141480299|SUPERIORITY||Median Difference (Final Values)|0.26|||||TWO_SIDED|95.0|-0.27|0.94||||||||0.94|-0.27|
70985423|NCT02926573|141480300|SUPERIORITY||Percent Difference|9.2|||||TWO_SIDED|95.0|-3.0|21.0||||||||21|-3.0|
70985424|NCT02926573|141480302|SUPERIORITY||Percent Difference|-2.0|||||TWO_SIDED|95.0|-15.0|11.0|||||"The estimation parameter is based on those participants who answered they were very satisfied with overall pain control."|||11|-15|
70985425|NCT02926573|141480303|SUPERIORITY||Mean Difference (Final Values)|7.4|||||TWO_SIDED|95.0|-3.4|18.3|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7AM.|||18.3|-3.4|
70985426|NCT02926573|141480303|SUPERIORITY||Mean Difference (Final Values)|8.7|||||TWO_SIDED|95.0|-2.9|20.3|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 10AM.|||20.3|-2.9|
70985427|NCT02926573|141480303|SUPERIORITY||Mean Difference (Final Values)|7.2|||||TWO_SIDED|95.0|-4.6|18.9|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7PM.|||18.9|-4.6|
71037642|NCT02412852|141582366|OTHER||||||||||||||||||\]The pharmacokinetics data are particularly sparse, and therefore substantial interpolations and imputations were required to produce an analyzable data set. Consequently, while not ideal, the Last Observation Carried Forward method was used for these data. There was a large amount of missing data which required imputation to determine results. The large amount of interpolations and imputations required for the pharmacokinetic analysis means that the pharmacokinetic results will need to be interpreted with caution. 3 X 3 Analysis of Variance used to compare Placebo to the two active groups. Missing data required imputation of available data.|||
70985428|NCT02926573|141480303|SUPERIORITY||Mean Difference (Final Values)|5.1|||||TWO_SIDED|95.0|-6.6|16.8|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7AM.|||16.8|-6.6|
70985429|NCT02926573|141480303|SUPERIORITY||Mean Difference (Final Values)|7.4|||||TWO_SIDED|95.0|-3.6|18.3|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 10AM.|||18.3|-3.6|
70985430|NCT02926573|141480303|SUPERIORITY||Mean Difference (Final Values)|8.0|||||TWO_SIDED|95.0|-5.6|21.6|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7PM.|||21.6|-5.6|
70985431|NCT02926573|141480303|SUPERIORITY||Mean Difference (Final Values)|10.1|||||TWO_SIDED|95.0|-3.5|23.8|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 3 7AM.|||23.8|-3.5|
70985432|NCT02926573|141480304|SUPERIORITY||Mean Difference (Final Values)|10.7|||||TWO_SIDED|95.0|-0.9|22.3|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7AM.|||22.3|-0.9|
70985433|NCT02926573|141480304|SUPERIORITY||Mean Difference (Final Values)|9.1|||||TWO_SIDED|95.0|-3.4|21.6|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 10AM.|||21.6|-3.4|
70985434|NCT02926573|141480304|SUPERIORITY||Mean Difference (Final Values)|6.3|||||TWO_SIDED|95.0|-6.1|18.6|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7PM.|||18.6|-6.1|
70985435|NCT02926573|141480304|SUPERIORITY||Mean Difference (Final Values)|5.3|||||TWO_SIDED|95.0|-7.3|17.8|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7AM.|||17.8|-7.3|
70985436|NCT02926573|141480304|SUPERIORITY||Mean Difference (Final Values)|11.2|||||TWO_SIDED|95.0|-1.4|23.8|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 10AM.|||23.8|-1.4|
70985437|NCT02926573|141480304|SUPERIORITY||Mean Difference (Final Values)|14.9|||||TWO_SIDED|95.0|-0.1|29.9|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7PM.|||29.9|-0.1|
70985438|NCT02926573|141480304|SUPERIORITY||Mean Difference (Final Values)|11.6|||||TWO_SIDED|95.0|-2.8|26.0|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 3 7AM.|||26.0|-2.8|
70985439|NCT02926573|141480305|SUPERIORITY||Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-14.7|11.9|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7AM.|||11.9|-14.7|
71097855|NCT05894564|141704135|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.74|1.33|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.33|0.74|
71097856|NCT05894564|141704135|OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.59|1.1|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.10|0.59|
71097857|NCT05894564|141704135|OTHER||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.59|1.12|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.12|0.59|
71097858|NCT05894564|141704135|OTHER||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.83|1.62|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.62|0.83|
71097859|NCT05894564|141704135|OTHER||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.7|1.34|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.34|0.70|
70985440|NCT02926573|141480305|SUPERIORITY||Mean Difference (Final Values)|5.3|||||TWO_SIDED|95.0|-8.6|19.2|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 10AM.|||19.2|-8.6|
70985441|NCT02926573|141480305|SUPERIORITY||Mean Difference (Final Values)|10.9|||||TWO_SIDED|95.0|-2.4|24.2|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7PM.|||24.2|-2.4|
70985442|NCT02926573|141480305|SUPERIORITY||Mean Difference (Final Values)|7.0|||||TWO_SIDED|95.0|-6.6|20.7|||||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7AM.|20.7|-6.6|
70985443|NCT02926573|141480305|SUPERIORITY||Mean Difference (Final Values)|8.0|||||TWO_SIDED|95.0|-6.4|22.3|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 10AM.|||22.3|-6.4|
71037643|NCT02412852|141582368|OTHER|ANOVA on only those subjects who completed testing.||||||0.05||||||The results were analyzed using an ANOVA with one between-subjects factor (Group: both placebo groups combined, 40 mg TV1001sr, and 80 mg TV1001sr); and one within-subjects factor (Visit: Visit 1, Visit 2, and Visit 3).|ANOVA|The means of the three groups were further analyzed using a post hoc comparison procedure (the Scheffé test).||||||0.05
71037644|NCT02412852|141582369|OTHER|The composite conduction measure and the composite velocity measure were analyzed using an Analysis of Variance with one between-subjects factor (Group: combined placebo, 40 mg TV1001, and 80 mg TV1001); and one within-subjects factor (Visit: Visit 1, Visit 2, and Visit 3).||||||0.15|||||||ANOVA|||||||.15
71097860|NCT05894564|141704136|OTHER||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.79|1.34|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.34|0.79|
71097861|NCT05894564|141704136|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.74|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.32|0.74|
71097862|NCT05894564|141704136|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.64|1.2|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.20|0.64|
71097863|NCT05894564|141704136|OTHER||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.7|1.34|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.34|0.70|
71097864|NCT05894564|141704136|OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.64|1.25|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.25|0.64|
70985444|NCT02926573|141480305|SUPERIORITY||Mean Difference (Final Values)|15.7|||||TWO_SIDED|95.0|-0.4|31.7|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7PM.|||31.7|-0.4|
70985445|NCT02926573|141480305|SUPERIORITY||Mean Difference (Final Values)|16.7|||||TWO_SIDED|95.0|0.0|33.4|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 3 7AM.|||33.4|0.0|
70985446|NCT02487745|141480306|SUPERIORITY||Odds Ratio (OR)|2.29||||0.05|TWO_SIDED|95.0|||||Regression, Logistic|||||||.05
70985447|NCT02487745|141480307|SUPERIORITY||Odds Ratio (OR)|3.88||||0.05|TWO_SIDED|95.0|||||Regression, Logistic|||||||.05
70985448|NCT04083144|141480324|SUPERIORITY||η2|0.01||||0.98|TWO_SIDED||||||Mixed Models Analysis|||||||0.98
70985449|NCT04083144|141480325|SUPERIORITY||η2|0.16||||0.76|TWO_SIDED||||||Mixed Models Analysis|||||||0.76
70985450|NCT04083144|141480326|SUPERIORITY||η2|0.02||||0.98|TWO_SIDED||||||Mixed Models Analysis|||||||0.98
70985451|NCT04083144|141480327|SUPERIORITY||η2|0.07||||0.24|TWO_SIDED||||||Mixed Models Analysis|||||||0.24
71037645|NCT02412852|141582370|OTHER|A 3 by 3 Analysis of Variance with one between-subjects factor (Combined placebo, 40 mg TV1001, or 80 mg TV1001) and one within-subjects factor (Visit 1, Visit 2, or Visit 3) was performed for HbA1c values.||||||0.36|||||||ANOVA|||||||.36
71037646|NCT02412852|141582371|OTHER|ANOVA to compare differences from baseline to completion of testing.||||||0.93|||||||ANOVA|||||||.93
70985452|NCT04083144|141480328|SUPERIORITY||η2|0.17||||0.26|TWO_SIDED||||||Mixed Models Analysis|||||||0.26
70985453|NCT00510692|141480336|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.06||||0.005|TWO_SIDED|95.0|-1.78|-0.35|||ANCOVA|||||-0.35|-1.78|0.005
70985454|NCT01765712|141480341|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.55|TWO_SIDED|95.0|-1.99|1.03|||t-test, 2 sided|||||1.03|-1.99|0.55
70985455|NCT02519231|141480381|SUPERIORITY||Mean Difference (Net)|-1.76|STANDARD_ERROR_OF_MEAN|5.0||0.11|TWO_SIDED|95.0||||The threshold for statistical significance was p =0.05|t-test, 2 sided|For days with bleeding/spotting outcomes, we used independent t-tests to compare the unadjusted mean difference between groups.|Treatment Difference = Naproxen - Placebo|We originally planned to enroll 60 subjects based on other similar studies that evaluated treatment for bleeding among women using contraception; as reported by Cohen et al., a sample size of 42 provided 80% power to detect a difference of 7 bleeding/spotting days in 30 days by two-sample t-test, allowing for an expected 20% drop-out.|We designed the study to include another site, in addition to the UW site enrolled participants. After 6 months of failed active recruitment at the other site, we discontinued that site from the study. Resources did not permit us to contract with an alternative recruitment site, and thus the protocol was revised to enroll 32 participants at the Seattle site only.|||.11
70985456|NCT02519231|141480382|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
70985457|NCT02428140|141480401|SUPERIORITY||Risk Ratio (RR)|3.29||||0.003|TWO_SIDED|95.0|1.45|7.42|||t-test, 2 sided|||||7.42|1.45|0.003
70985458|NCT02428140|141480402|SUPERIORITY||Risk Difference (RD)|10.7||||0.005|TWO_SIDED|95.0|3.4|17.9|||t-test, 2 sided|||||17.9|3.4|.005
70985459|NCT02428140|141480403|SUPERIORITY||Risk Difference (RD)|2.7||||0.28|TWO_SIDED|95.0|-1.0|6.3|||t-test, 2 sided|||||6.3|-1.0|0.28
71037647|NCT00841542|141582372|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|98.19||||||90.0|94.2|102.34|||||Bioequivalence is established when 90% Confidence Interval falls withing 80 - 125|||102.34|94.20|
70985460|NCT02428140|141480405|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-1.8|1.8||||||||1.8|-1.8|
71037648|NCT00841542|141582373|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|98.86||||||90.0|93.38|104.66|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.66|93.38|
71037649|NCT00841542|141582374|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|99.22||||||90.0|93.87|104.88|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.88|93.87|
71037650|NCT00924638|141582377|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|6.4||||0.0006|TWO_SIDED|95.0|1.9|21.7|||Log Rank||A hazard ratio of \> 1 indicates that Continuous Monitoring is superior to Control in detecting AF.|||21.7|1.9|0.0006
71037651|NCT00924638|141582378|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|7.3|||<|0.0001|TWO_SIDED|95.0|2.6|20.8|||Log Rank||A hazard ratio of \> 1 indicates that Continuous Monitoring is superior to Control in detecting AF.|||20.8|2.6|<0.0001
70985461|NCT02428140|141480406|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-3.2|3.2||||||||3.2|-3.2|
70985462|NCT02746679|141480415|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||<0.001
70985463|NCT02746679|141480416|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
70985464|NCT02746679|141480417|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
70985465|NCT02746679|141480418|SUPERIORITY_OR_OTHER|||||||0.024|||||||Chi-squared|||||||0.024
70985466|NCT02746679|141480419|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||<0.001
70985467|NCT02746679|141480420|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||0.001
70985468|NCT02746679|141480421|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||0.003
70985469|NCT02746679|141480422|SUPERIORITY_OR_OTHER|||||||0.024|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||0.024
70985470|NCT02746679|141480423|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||0.004
70985471|NCT02746679|141480424|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||<0.001
70985472|NCT02746679|141480425|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||<0.001
70985473|NCT02746679|141480426|SUPERIORITY_OR_OTHER|||||||0.277|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||0.277
70985474|NCT02746679|141480427|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||0.001
70985475|NCT02961764|141480454|SUPERIORITY||Odds Ratio (OR)|0.289|||<|0.001|TWO_SIDED|95.0|0.156|0.532|||Fisher Exact|||||0.532|0.156|<0.001
70985476|NCT02961764|141480455|SUPERIORITY|||||||0.005|||||||t-test, 1 sided|||||||0.005
70985477|NCT02961764|141480456|SUPERIORITY|||||||0.05|||||||t-test, 1 sided|||||||0.050
70985478|NCT02961764|141480458|SUPERIORITY|||||||0.002|||||||t-test, 1 sided|||||||0.002
70985479|NCT01422304|141480489|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.7|||||TWO_SIDED|95.0|0.38|1.29|||Cochran-Mantel-Haenszel||Relative risk is Sugammadex versus Usual Care|Cochran-Mantel-Haenszel method was stratified for renal function (estimated creatinine clearance \< or ≥ 60 mL/min) and prophylactic antithrombotic therapy (including low molecular weight heparin \[LMWH\], including unfractionated heparin \[UFH\], or not including either LMWH or UFH)||1.29|0.38|
70985480|NCT01422304|141480490|SUPERIORITY_OR_OTHER_LEGACY||Geometric Mean Ratio (GMR) (%)|5.5|||||TWO_SIDED|95.0|3.7|7.3|||Constrained Longitudinal Data Analysis|Model included those in APaT population with any baseline or post baseline aPTT value in 10 or 60 minute window (Sugammadex, Usual Care N=567, 548)|Estimate of difference in Sugammadex versus Usual Care change from baseline at 10 minutes post dose calculated with log of aPTT values as dependent variable. Results transformed back to GMR of respective changes (expressed as %, = \[GMR - 1\]\*100).|Model was restricted to have no difference between treatment groups for baseline assessment, and was adjusted for center, usual care group (active reversal or spontaneous recovery), renal function (estimated creatinine clearance \< or ≥ 60 mL/min), prophylactic antithrombotic therapy (including LMWH, including UFH, or not including either LMWH or UFH), type of hip/knee surgical procedure, and the interaction of time by treatment.||7.3|3.7|
71097865|NCT05894564|141704137|OTHER||Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.61|1.01|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.01|0.61|
71097866|NCT05894564|141704137|OTHER||Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.64|1.11|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.11|0.64|
70985481|NCT01422304|141480490|SUPERIORITY_OR_OTHER_LEGACY||GMR (%)|0.9||||||95.0|-0.9|2.8|||Constrained Longitudinal Data Analysis|Model included those in APaT population with any baseline or post baseline aPTT value in 10 or 60 minute window (Sugammadex, Usual Care N=567, 548)|Estimate of difference in Sugammadex versus Usual Care change from baseline at 60 minutes post dose calculated with log of aPTT values as dependent variable. Results transformed back to GMR of respective changes (expressed as %, = \[GMR - 1\]\*100).|Model was restricted to have no difference between treatment groups for baseline assessment, and was adjusted for center, usual care group (active reversal or spontaneous recovery), renal function (estimated creatinine clearance \< or ≥ 60 mL/min), prophylactic antithrombotic therapy (including LMWH, including UFH, or not including either LMWH or UFH), type of hip/knee surgical procedure, and the interaction of time by treatment.||2.8|-0.9|
70985482|NCT01422304|141480491|SUPERIORITY_OR_OTHER_LEGACY||GMR (%)|3.0|||||TWO_SIDED|95.0|1.3|4.7|||Constrained Longitudinal Data Analysis|Model included those in APaT population with any baseline or post baseline PT(INR) value in 10 or 60 minute window (Sugammadex, Usual Care N=567, 548)|Estimate of difference in Sugammadex versus Usual Care change from baseline at 10 minutes post dose calculated with log of PT(INR) values as dependent variable. Results transformed back to GMR of respective changes (expressed as %, = \[GMR - 1\]\*100).|Model was restricted to have no difference between treatment groups for baseline assessment, and was adjusted for center, usual care group (active reversal or spontaneous recovery), renal function (estimated creatinine clearance \< or ≥ 60 mL/min), prophylactic antithrombotic therapy (including LMWH, including UFH, or not including either LMWH or UFH), type of hip/knee surgical procedure, and the interaction of time by treatment.||4.7|1.3|
70985483|NCT01422304|141480491|SUPERIORITY_OR_OTHER_LEGACY||GMR (%)|0.9|||||TWO_SIDED|95.0|-1.0|2.9|||Constrained Longitudinal Data Analysis|Model included those in APaT population with any baseline or post baseline PT(INR) value in 10 or 60 minute window (Sugammadex, Usual Care N=567, 548)|Estimate of difference in Sugammadex versus Usual Care change from baseline at 60 minutes post dose calculated with log of PT(INR) values as dependent variable. Results transformed back to GMR of respective changes (expressed as %, = \[GMR - 1\]\*100).|Model was restricted to have no difference between treatment groups for baseline assessment, and was adjusted for center, usual care group (active reversal or spontaneous recovery), renal function (estimated creatinine clearance \< or ≥ 60 mL/min), prophylactic antithrombotic therapy (including LMWH, including UFH, or not including either LMWH or UFH), type of hip/knee surgical procedure, and the interaction of time by treatment.||2.9|-1.0|
70985484|NCT01422304|141480492|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (%)|-0.6|||||TWO_SIDED|95.0|-3.0|1.8|||Miettinen and Nurminen||Risk difference (%) = Sugammadex incidence - Usual Care incidence|||1.8|-3.0|
70985485|NCT01422304|141480493|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (%)|-1.4|||||TWO_SIDED|95.0|-3.4|0.5|||Miettinen and Nurminen||Risk difference (%) = Sugammadex incidence - Usual Care incidence|||0.5|-3.4|
70985486|NCT01422304|141480494|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (%)|-0.9|||||TWO_SIDED|95.0|-3.1|1.2|||Miettinen and Nurminen||Risk difference (%) = Sugammadex incidence - Usual Care incidence|||1.2|-3.1|
70985487|NCT01422304|141480495|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (%)|0.3|||||TWO_SIDED|95.0|-0.7|1.5|||Miettinen and Nurminen||Risk difference (%) = Sugammadex incidence - Usual Care incidence|||1.5|-0.7|
70985488|NCT01422304|141480497|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.2|||||TWO_SIDED|95.0|-45.0|30.5|||Generalized Linear Model||Difference is Sugammadex versus Usual Care. A negative value indicates that the average adjusted drainage volume was lower in the sugammadex treatment group.|Generalized Linear Model was adjusted for strata (renal function and use of prophylactic antithrombotic therapy) and investigational site.||30.5|-45.0|
71097867|NCT05894564|141704137|OTHER||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.63|1.12|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.12|0.63|
71097868|NCT05894564|141704137|OTHER||Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.6|1.12|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.12|0.60|
70985489|NCT01422304|141480498|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (%)|-2.7|||||TWO_SIDED|95.0|-7.4|2.0|||Miettinen and Nurminen||Risk difference (%) = Sugammadex incidence - Usual Care incidence, adjusted for strata and investigational site|Miettinen and Nurminen Method was adjusted for strata (renal function and use of prophylactic antithrombotic therapy) and investigational site||2.0|-7.4|
70985490|NCT01422304|141480499|SUPERIORITY_OR_OTHER_LEGACY||GMR|1.1|||||TWO_SIDED|95.0|0.98|1.24|||Generalized Linear Model||GMR is Sugammadex versus Usual Care|Generalized Linear Model was applied to transfusion volume transformed to the log-scale, adjusted for strata (renal function and use of prophylactic antithrombotic therapy) and investigational site. Result and 95% Confidence Interval was transformed back to the original scale.||1.24|0.98|
70985491|NCT01422304|141480500|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-0.4|3.1|||Generalized Linear Model||Difference is Sugammadex versus Usual Care. A positive value indicates that the average adjusted reduction in Hgb at Visit 3 (bleeding index) was lower in the sugammadex treatment group.|Generalized Linear Model was adjusted for strata (renal function and use of prophylactic antithrombotic therapy), investigational site and baseline hemoglobin value.||3.1|-0.4|
70985492|NCT01422304|141480501|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (%)|-1.6|||||TWO_SIDED|95.0|-6.3|3.1|||Miettinen and Nurminen||Risk difference (%) = Sugammadex incidence - Usual Care incidence|||3.1|-6.3|
70985493|NCT00866294|141480512|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4|||<|0.001|TWO_SIDED|95.0|-3.8|-1.1||The hypothesis test was conducted with a two-sided significance level of 5% to show the superiority of paroxetine CR relative to placebo.|ANCOVA|The primary analysis was based on an ANCOVA with a model adjusting for baseline HAM-D total score and region (Japan and South Korea).|Mean difference = paroxetine CR minus placebo|||-1.1|-3.8|<0.001
70985494|NCT04799782|141480518|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|||||||0.015
70985495|NCT04799782|141480519|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||||||0.82
70985496|NCT02606877|141480520|OTHER||T1/R1 Ratio (%)|88.58|STANDARD_DEVIATION|45.1|||TWO_SIDED|90.0|65.4|119.97|||ANOVA|The analysis of variance (ANOVA) model on a logarithmic scale including effects: 'subject' and 'treatment'.|To get,geometric mean ratio and Confidence Interval,least square estimates of log-transformed PK endpoint for T1 and R1 were back transformed to original scale. Standard Deviation is actually the intra-individual geometric Coefficient of Variance(%).|||119.97|65.40|
70985497|NCT02606877|141480521|OTHER||T1/R1 Ratio (%)|80.63|STANDARD_DEVIATION|74.6|||TWO_SIDED|90.0|51.27|126.79|||ANOVA|The analysis of variance (ANOVA) model on a logarithmic scale including effects: 'subject' and 'treatment'.|To get,geometric mean ratio and Confidence Interval,least square estimates of log-transformed PK endpoint for T1 and R1 were back transformed to original scale. Standard Deviation is actually the intra-individual geometric Coefficient of Variance(%).|||126.79|51.27|
70985498|NCT02606877|141480522|OTHER||T2/R2 Ratio (%)|97.17|STANDARD_DEVIATION|14.1|||TWO_SIDED|90.0|87.84|107.48|||ANOVA|The analysis of variance (ANOVA) model on a logarithmic scale including effects: 'subject' and 'treatment'.|To get,geometric mean ratio and Confidence Interval,least square estimates of log-transformed PK endpoint for T2 and R2 were back transformed to original scale. Standard Deviation is actually the intra-individual geometric Coefficient of Variance(%).|||107.48|87.84|
70985499|NCT02606877|141480523|OTHER||T2/R2 Ratio (%)|99.49|STANDARD_DEVIATION|17.4|||TWO_SIDED|90.0|87.94|112.56|||ANOVA|The analysis of variance (ANOVA) model on a logarithmic scale including effects: 'subject' and 'treatment'.|To get,geometric mean ratio and Confidence Interval,least square estimates of log-transformed PK endpoint for T2 and R2 were back transformed to original scale. Standard Deviation is actually the intra-individual geometric Coefficient of Variance(%).|||112.56|87.94|
70985500|NCT02606877|141480524|OTHER||T1/R1 Ratio (%)|89.49|STANDARD_DEVIATION|44.3|||TWO_SIDED|90.0|66.33|120.73|||ANOVA|The analysis of variance (ANOVA) model on a logarithmic scale including effects: 'subject' and 'treatment'.|To get,geometric mean ratio and Confidence Interval,least square estimates of log-transformed PK endpoint for T1 and R1 were back transformed to original scale. Standard Deviation is actually the intra-individual geometric Coefficient of Variance(%).|||120.73|66.33|
70985501|NCT02989727|141480536|SUPERIORITY||ANOVA estimate|1.88|STANDARD_ERROR_OF_MEAN|3.51||0.59|TWO_SIDED||||||ANOVA|||Weighted ANOVA models were used to compare change scores between lamotrigine and placebo groups while testing for interactions by melancholic status. The estimate and test reported is for the the interaction between treatment condition and melancholic status.||||.59
70985502|NCT02989727|141480537|SUPERIORITY||ANOVA estimate|0.5|STANDARD_ERROR_OF_MEAN|2.56||0.84|TWO_SIDED||||||ANOVA|||Weighted ANOVA models were used to compare change scores between lamotrigine and placebo groups while testing for interactions by melancholic status. The estimate and test reported is for the the interaction between treatment condition and melancholic status.||||.84
70985503|NCT02989727|141480538|SUPERIORITY||Cox Proportional Hazard|1.2|STANDARD_ERROR_OF_MEAN|0.1||0.08|TWO_SIDED||||||Regression, Cox|||"Weighted Cox regression with treatment condition (lamotrigine vs. placebo) predicting treatment response. Response is defined as a score reduction of at least 50% from baseline. The outcome variable is binary coded with 1 being a response at anytime point and 0 indicating no response."||||.08
70985504|NCT02989727|141480538|SUPERIORITY||Cox Proportional Hazard|1.08|STANDARD_ERROR_OF_MEAN|0.12||0.53|TWO_SIDED||||||Regression, Cox|||"Weighted Cox regression with treatment condition (lamotrigine vs. placebo) predicting treatment response. Response is defined as a score reduction of at least 50% from baseline. The outcome variable is binary coded with 1 being a response at anytime point and 0 indicating no response."||||.53
70985505|NCT02989727|141480546|SUPERIORITY||Cox Proportional Hazard|1.27|STANDARD_ERROR_OF_MEAN|0.11||0.02|TWO_SIDED||||||Regression, Cox|||"Weighted Cox regression with treatment condition (lamotrigine vs. placebo) predicting treatment response. Response is defined as a score reduction of at least 50% from baseline. The outcome variable is binary coded with 1 being a response at any time point and 0 indicating no response."||||.02
70985506|NCT02989727|141480546|SUPERIORITY||Cox Proportional Hazard|1.05|STANDARD_ERROR_OF_MEAN|0.13||0.73|TWO_SIDED||||||Regression, Cox|||"Weighted Cox regression with treatment condition (lamotrigine vs. placebo) predicting treatment response. Response is defined as a score reduction of at least 50% from baseline. The outcome variable is binary coded with 1 being a response at any time point and 0 indicating no response."||||.73
70985507|NCT00515463|141480559|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||||95.0|-0.7|0.7|||||Risk difference \> 0 indicates that incidence of binding anti-denosumab antibodies in denosumab PFS is greater than denosumab vial. 95% CI based on a normal approximation with continuity correction.|||0.7|-0.7|
70985508|NCT00515463|141480560|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||||95.0|-0.7|0.7||||||||0.7|-0.7|
70985509|NCT02222129|141480632|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Statistical analysis was performed using SAS, version 9.2 (Statistical Analysis Software, Cary, NC). All power calculations were at the 80% level with an alpha of 0.05. Based upon opioid consumption data previously reported for robotic-assisted laparoscopic prostatectomy, a sample size of 74 would be necessary to detect a 10 mg difference in morphine equivalents totaled over the entire hospital stay. (Webster TM, Herrell SD, Chang SS, et al. The Journal of Urology 2005;174(3):912-914.||||0.39
70985510|NCT03990766|141480662|SUPERIORITY||Risk Difference (RD)|3.3|||||TWO_SIDED|95.0|-35.6|42.3||||||||42.3|-35.6|
70985511|NCT03990766|141480663|SUPERIORITY||Median Difference (Net)|1.0|||||TWO_SIDED|95.0|-3.0|5.0||||||||5|-3|
70985512|NCT03990766|141480664|SUPERIORITY||Median Difference (Net)|-10.0|||||TWO_SIDED|95.0|-15.0|-4.0||||||The within-subject change in QOD-NS scores from baseline and 6 weeks was calculated for each individual patient. Then the median of all the patients' change in score for each cohort was calculated. Because these were within-subject changes in scores, the median difference values for each cohort do not necessarily correspond with simply subtracting the median change in score in the theophylline cohort from the median change in score in the placebo cohort.||-4|-15|
70985513|NCT03990766|141480665|SUPERIORITY||Median Difference (Net)|7.0|||||TWO_SIDED|95.0|-2.0|17.0||||||The within-subject change in ODOR scores from baseline and 6 weeks was calculated for each individual patient. Then the median of all the patients' change in score for each cohort was calculated. Because these were within-subject changes in scores, the median difference values for each cohort do not necessarily correspond with simply subtracting the median change in score in the theophylline cohort from the median change in score in the placebo cohort. We confirmed the reported results.||17|-2|
70985514|NCT03825042|141480678|SUPERIORITY||Mean Difference (Final Values)|-21.01||||0|TWO_SIDED|95.0|-26.8|-15.2|||ANCOVA|||||-15.20|-26.80|0.0000
70985515|NCT03825042|141480679|SUPERIORITY||Mean Difference (Final Values)|-6.08||||0|TWO_SIDED|95.0|-8.45|-3.61|||ANCOVA|||||-3.61|-8.45|0.0000
70985516|NCT03825042|141480680|SUPERIORITY||Mean Difference (Final Values)|-14.56||||0|TWO_SIDED|95.0|-20.02|-9.11|||ANCOVA|||||-9.11|-20.02|0.0000
70985517|NCT02316470|141480681|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70985518|NCT02316470|141480681|SUPERIORITY_OR_OTHER|||||||0.0261|||||||Cochran-Mantel-Haenszel|||||||0.0261
70985519|NCT02316470|141480681|SUPERIORITY_OR_OTHER|||||||0.0364|||||||Cochran-Mantel-Haenszel|||||||0.0364
70985520|NCT02316470|141480681|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70985521|NCT02316470|141480681|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70985522|NCT02316470|141480681|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70985523|NCT02316470|141480681|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70985524|NCT02316470|141480682|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value was \<0.0001 at each time point (Day 14, 28, 35, 120, 210)|Fisher-Freeman-Halton Test|||statistical test was applied across all treatment groups at each of the listed time points.||||<0.0001
70985525|NCT02316470|141480683|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value was \<0.0001 at each time point (Day 14, 28, 35, 56, 120, 210)|Fisher-Freeman-Halton Test|||statistical test was applied across all treatment groups at each of the listed time points.||||<0.0001
70985526|NCT02316470|141480684|SUPERIORITY_OR_OTHER||||||<|0.0001||||||the p-value was \<0.0001 at each time point (Day 14, 28, 35, 56, 120, 210)|Fisher-Freeman-Halton Test|||statistical test was applied across all treatment groups at each of the listed time points.||||<0.0001
70985527|NCT00089843|141480737|SUPERIORITY_OR_OTHER_LEGACY||Percent change between 0 and 12 months|3.2|||<|0.0001|TWO_SIDED|95.0|1.8|4.6||This p value was for the effect of Actonel (risedronate) on bone mineral density of the spine.|Factorial analysis|||Factorial analysis||4.6|1.8|<0.0001
70985528|NCT00089843|141480737|SUPERIORITY_OR_OTHER_LEGACY||Percent change between 0 and 12 months|-0.6||||0.41|TWO_SIDED|95.0|-2.0|0.8||This p value was for the effect of testosterone on bone mineral density of the spine.|Factorial analysis|||Factorial analysis||0.8|-2.0|0.41
70985529|NCT00089843|141480738|SUPERIORITY_OR_OTHER_LEGACY||Percent change between 0 and 12 months|-41.0||||0.002|TWO_SIDED|95.0||||This p value was for the effect of Actonel (risedronate).|Factorial analysis|||Factorial analysis||||0.002
70985530|NCT00089843|141480738|SUPERIORITY_OR_OTHER_LEGACY||Percent change between 0 and 12 months|-11.0||||0.39||95.0||||This p value was for the effect of testosterone.|Factorial analysis|||Factorial analysis||||0.39
70985531|NCT02639182|141480770|SUPERIORITY|The difference between treatment groups was tested using a stratified log rank test at a one-sided 0.1 significance level.||||||0.983||||||The stratification factors were the ECOG PS at baseline and the number of prior systemic renal cell carcinoma (RCC) regimens, without any other covariate(s). The model contained terms for treatment group and stratum.|Log Rank|||||||0.983
70985532|NCT02639182|141480771|SUPERIORITY|The difference between treatment groups was tested using a stratified log rank test at a one-sided 0.1 significance level.|Hazard Ratio (HR)|1.423||||0.11|TWO_SIDED|95.0|0.924|2.192||The stratification factors were the ECOG PS at baseline and the number of prior systemic RCC regimens, without any other covariate(s). The model contained terms for treatment group and stratum.|Log Rank|||||2.192|0.924|0.110
71037652|NCT00924638|141582379|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.25|TWO_SIDED|95.0|0.35|1.32|||Log Rank||A hazard ratio of \< 1 indicates that the incidence rate of recurrent stroke or TIA is lower in the Continuous Monitoring arm compared to the Control arm.|||1.32|0.35|0.25
71037653|NCT00924638|141582380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.8|||||TWO_SIDED|95.0|2.8|14.8|||||A difference of greater than 0 means that a higher percentage of subjects in the Continuous Monitoring arm were using the OAC drugs at the 12 months visit compared to the Control arm.|||14.8|2.8|
71037654|NCT00924638|141582381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-2.3|3.1|||||A difference of greater than 0 means that a higher percentage of subjects in the Continuous Monitoring arm were using the anti-arrhythmic drugs at the 12 months visit compared to the Control arm.|||3.1|-2.3|
71037655|NCT00924638|141582382|SUPERIORITY_OR_OTHER|||||||0.11|||||||t-test, 2 sided|||||||0.11
71097869|NCT05894564|141704137|OTHER||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.67|1.24|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.24|0.67|
70985533|NCT02639182|141480772|SUPERIORITY||Odds Ratio (OR)|0.4||||0.062|TWO_SIDED|95.0|0.1|1.1||A Cochran-Mantel-Haenszel (CMH) analysis of the ORR, stratified for baseline ECOG-PS and number of prior systemic therapies for RCC, was conducted at a two-sided significance level of 0.05.|Cochran-Mantel-Haenszel|Stratified Mantel-Haenszel estimate of the odds ratio for experiencing objective response, with the axitinib arm as the reference level, was reported.||||1.1|0.1|0.062
70985534|NCT02639182|141480773|SUPERIORITY||Hazard Ratio (HR)|0.376||||0.439||95.0|0.031|4.482||The stratification factors were the ECOG PS at baseline and the number of prior systemic RCC regimens, without any other covariate(s). The model contained terms for treatment group and stratum.|Log Rank|The difference between treatment groups was tested using a stratified log rank test at a one-sided 0.1 significance level.||||4.482|0.031|0.439
70985535|NCT02639182|141480774|SUPERIORITY|||||||0.746||||||Test conducted at a 2-sided significance level of 0.05. The stratification factors were the ECOG PS at baseline and number of prior systemic RCC regimens.|Log Rank|||||||0.746
70985536|NCT02639182|141480775|SUPERIORITY|A CMH analysis of the DCR, stratified for baseline ECOG-PS and number of prior systemic therapies for RCC, was conducted at a two-sided significance level of 0.05.|Odds Ratio (OR)|0.5||||0.152|TWO_SIDED|95.0|0.2|1.3||The stratified Mantel-Haenszel estimate of the odds ratio for experiencing objective response, with the axitinib arm as the reference level, was reported as a measure of relative treatment effect, along with its two-sided 95% CI.|Cochran-Mantel-Haenszel|||||1.3|0.2|0.152
70985537|NCT03864237|141480792|SUPERIORITY||beta coefficient for condition|0.53|STANDARD_ERROR_OF_MEAN|0.93||0.568|TWO_SIDED|95.0|-1.31|2.37|||Regression, Linear|Regression controls for baseline value of outcome and sex to determine pre-post change in the outcome as a function of condition.||||2.37|-1.31|0.568
70985538|NCT03864237|141480793|SUPERIORITY||beta coefficient for condition|1.22|STANDARD_ERROR_OF_MEAN|0.69||0.077|TWO_SIDED|95.0|-0.13|2.59|||Regression, Linear|||||2.59|-0.13|0.077
70985539|NCT03864237|141480794|SUPERIORITY||beta coefficient for condition|-1.21|STANDARD_ERROR_OF_MEAN|1.17||0.3|TWO_SIDED|95.0|-3.52|1.11|||Regression, Linear|||||1.11|-3.52|0.30
70985540|NCT03864237|141480795|SUPERIORITY||beta coefficient for condition|0.84|STANDARD_ERROR_OF_MEAN|1.09||0.44|TWO_SIDED|95.0|-1.31|3.0|||Regression, Linear|||||3.0|-1.31|0.44
70985541|NCT03864237|141480796|SUPERIORITY||Beta coefficient for condition|-0.25|STANDARD_ERROR_OF_MEAN|1.29||0.845|TWO_SIDED|95.0|-2.81|2.3|||Regression, Linear|||||2.30|-2.81|0.845
70985542|NCT03864237|141480797|SUPERIORITY||Beta coefficient for condition|0.3|STANDARD_ERROR_OF_MEAN|1.01||0.77|TWO_SIDED|95.0|-1.72|2.31|||Regression, Linear|||||2.31|-1.72|0.77
70985543|NCT03864237|141480798|SUPERIORITY||Beta coefficient for condition|1.77|STANDARD_ERROR_OF_MEAN|1.4||0.21|TWO_SIDED|95.0|-1.0|4.54|||Regression, Linear|||||4.54|-1.0|0.21
70985544|NCT03069690|141480799|SUPERIORITY||Mean Difference (Net)|-0.3996|STANDARD_ERROR_OF_MEAN|2.665||0.8|TWO_SIDED|95.0|-5.649|4.85||The value was not adjusted for multiple comparisons.|ANCOVA|||||4.850|-5.649|.80
70985545|NCT03069690|141480799|SUPERIORITY||Mean Difference (Net)|-3.387|STANDARD_ERROR_OF_MEAN|2.755||0.8|TWO_SIDED|95.0|-8.813|2.039||The value was not adjusted for multiple comparisons.|ANCOVA|||||2.039|-8.813|.80
70985546|NCT03069690|141480799|SUPERIORITY||Mean Difference (Net)|-1.1729|STANDARD_ERROR_OF_MEAN|2.72||0.8|TWO_SIDED|95.0|-6.53|4.184||The value was not adjusted for multiple comparisons.|ANCOVA|||||4.184|-6.530|.80
70985547|NCT02385123|141480810|OTHER||||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
70985548|NCT02385123|141480811|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
71037656|NCT00924638|141582383|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.37||||0.33|TWO_SIDED|95.0|0.73|2.6|||Log Rank||A hazard ratio of \< 1 indicates that the incidence rate of cardiovascular or stroke/TIA related hospitalization is lower in the Continuous Monitoring arm compared to the Control arm.|||2.60|0.73|0.33
71037657|NCT00841659|141582427|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|99.96||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.|||||
71037658|NCT00841659|141582428|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|93.58||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.|||||
71037659|NCT00841659|141582429|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|94.29||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.|||||
71037660|NCT00073307|141582431|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.146||95.0|0.74|1.04||According to O'Brien-Fleming type alpha spending function and total actual deaths at final analysis, threshold for statistical significance was alpha=0.037 (two-sided).|Log Rank||Two treatment groups compared using log-rank test (Sorafenib over Placebo) stratified by country and Motzer category|Sample size based on primary efficacy endpoint of OS. Clinically meaningful improvement defined as 33.3% improvement in median OS (i.e. HR of 0.75, Sorafenib over Placebo). With overall two-sided alpha of 0.04, 90% power and randomization of 1:1, two formal interim analyses and one final analysis were planned using O'Brien-Fleming type error spending function, and a total of approximately 540 events (deaths) were required for the final analysis.||1.04|0.74|0.146
70985549|NCT02385123|141480812|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
70985550|NCT02385123|141480813|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people|||
70985551|NCT02385123|141480814|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
70985552|NCT02385123|141480815|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
70985553|NCT02385123|141480816|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
70985554|NCT02385123|141480817|OTHER|||||||||||||||||A single group analysis was used to determine this outcome measure.|A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
70985555|NCT02385123|141480818|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
71097870|NCT05894564|141704138|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.81|1.27|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.27|0.81|
71097871|NCT05894564|141704138|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.76|1.18|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.18|0.76|
70985556|NCT02385123|141480819|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
70985557|NCT02385123|141480820|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
70985558|NCT02385123|141480821|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
70985559|NCT02385123|141480822|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
71097872|NCT05894564|141704138|OTHER||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.72|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.14|0.72|
70985560|NCT02385123|141480823|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
70985561|NCT02385123|141480825|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
70985562|NCT02385123|141480826|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
70985563|NCT02385123|141480827|OTHER|Single group analysis.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
70985564|NCT02385123|141480828|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
70985565|NCT02385123|141480829|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
70985566|NCT02385123|141480830|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
70985567|NCT02385123|141480831|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
70985568|NCT02544984|141480844|SUPERIORITY|||||||0.473|||||||negative binomial model|negative binomial model adjusting for use of Synagis and tracheostomy||The numbers of unscheduled clinic visits due to respiratory symptoms are compared.||||0.473
70985569|NCT02544984|141480844|SUPERIORITY|||||||0.505|||||||negative binomial model|negative binomial model adjusting for use of Synagis and tracheostomy||Unscheduled clinic visits due to symptoms other than respiratory symptoms are compared||||0.505
70985570|NCT02544984|141480844|SUPERIORITY|||||||0.047|||||||negative binomial model|negative binomial model adjusting for use of Synagis and tracheostomy||Numbers of emergency room visits are compared||||0.047
70985571|NCT02544984|141480844|SUPERIORITY|||||||0.675|||||||negative binomial model|negative binomial model adjusting for use of Synagis and tracheostomy||Numbers of hospital admissions are compared||||0.675
70985572|NCT02544984|141480845|SUPERIORITY|||||||0.435|||||||negative binomial model|negative binomial model adjusting for use of Synagis and tracheostomy||||||0.435
70985573|NCT01845077|141480858|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|99.3|||||TWO_SIDED|90.0|95.3|103.5|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||103.5|95.3|
70985574|NCT01845077|141480858|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|101.5|||||TWO_SIDED|90.0|98.4|104.7|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||One patient was excluded from this analysis due to the lack of the 72h sample for the L+M1000 fed treatment.||104.7|98.4|
70985575|NCT01845077|141480858|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|100.9|||||TWO_SIDED|90.0|98.2|103.7|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||103.7|98.2|
71037661|NCT00073307|141582432|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0287||95.0|0.62|0.97||According to O'Brien-Fleming type alpha spending function and total actual deaths at final analysis, threshold for statistical significance was alpha=0.037 (two-sided).|Log Rank||Two treatment groups compared using log-rank test (Sorafenib over Placebo) stratified by country and Motzer category|Sample size based on primary efficacy endpoint of OS. Clinically meaningful improvement defined as 33.3% improvement in median OS (i.e. HR of 0.75, Sorafenib over Placebo). With overall two-sided alpha of 0.04, 90% power and randomization of 1:1, two formal interim analyses and one final analysis were planned using O'Brien-Fleming type error spending function, and a total of approximately 540 events (deaths) were required for the final analysis.||0.97|0.62|0.0287
71037662|NCT00073307|141582433|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.44|||<|1e-06||95.0|0.35|0.55|||Log Rank||Two treatment groups compared using log-rank test (Sorafenib over Placebo) stratified by country and Motzer category|The planned final PFS analysis was to be performed when approximately 363 progressions or deaths (if death occurred before progression) were observed. The analysis had power of 90% to detect a 50% increase in PFS using a two-sided alpha of 0.01||0.55|0.35|<0.000001
71037663|NCT00073307|141582434|SUPERIORITY_OR_OTHER||Difference in response rates (CR+PR)|-2.1||||||95.0|-3.7|-0.6|||Cochran-Mantel-Haenszel|Adjustments for country and Motzer category|difference in response rates (CR+PR) = Placebo - Sorafenib|||-0.6|-3.7|
71037664|NCT00073307|141582435|SUPERIORITY_OR_OTHER|||||||0.98|||||||random coefficient model|Random coefficient model adjusted for baseline Motzer score, baseline FKSI-10 score and relative day of FKSI-10 completion.||Approximately 200 subjects per group, assuming a 10% drop out rate, were required to detect a 2 point difference between sorafenib and placebo at approximately 80% power with a two-sided alpha of 0.05||||0.98
71037665|NCT00073307|141582436|SUPERIORITY_OR_OTHER|||||||0.83|||||||random coefficient model|Random coefficient model adjusted for baseline Motzer score, baseline PWB score and relative day of PWB completion.||Approximately 200 subjects per group, assuming a 10% drop out rate, were required to detect a 2 point difference between sorafenib and placebo at approximately 80% power with a two-sided alpha of 0.05||||0.83
71037666|NCT01438060|141582437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.802|TWO_SIDED|95.0|-1.15|1.49||Baseline data was evaluated by analysis of variance (ANOVA) with treatment and study center as main effects.|ANOVA||Model based estimate.|Analysis at Baseline (Day 0)||1.49|-1.15|0.802
70985576|NCT01845077|141480859|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|94.9|||||TWO_SIDED|90.0|86.8|103.6|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||103.6|86.8|
70985577|NCT01845077|141480859|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|96.8|||||TWO_SIDED|90.0|90.2|103.8|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||103.8|90.2|
70985578|NCT01845077|141480859|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|108.6||||||90.0|99.5|118.5|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||118.5|99.5|
70985579|NCT01845077|141480860|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|103.7|||||TWO_SIDED|90.0|97.1|110.8|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||110.8|97.1|
70985580|NCT01845077|141480860|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|105.3|||||TWO_SIDED|90.0|99.9|111.0|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||111.0|99.9|
70985581|NCT01845077|141480860|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|96.9|||||TWO_SIDED|90.0|90.2|104.1|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||104.1|90.2|
70985582|NCT01845077|141480861|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|96.9|||||TWO_SIDED|90.0|86.8|108.2|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||108.2|86.8|
70985583|NCT01845077|141480861|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|99.7|||||TWO_SIDED|90.0|96.1|103.5|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||103.5|96.1|
70985584|NCT01845077|141480861|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|95.9|||||TWO_SIDED|90.0|86.7|106.0|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||106.0|86.7|
70985585|NCT01845077|141480862|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|96.8|||||TWO_SIDED|90.0|86.6|108.2|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||108.2|86.6|
70985586|NCT01845077|141480862|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|99.4|||||TWO_SIDED|90.0|95.6|103.4|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||103.4|95.6|
70985587|NCT01845077|141480862|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|99.3|||||TWO_SIDED|90.0|90.1|109.5|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||109.5|90.1|
70985588|NCT01845077|141480863|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|96.5|||||TWO_SIDED|90.0|84.8|109.8|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||109.8|84.8|
70985589|NCT01845077|141480863|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|103.2|||||TWO_SIDED|90.0|98.9|107.7|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||107.7|98.9|
71037667|NCT01438060|141582437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02||||0.169|TWO_SIDED|95.0|-2.49|0.44||ANCOVA model for LOCF data set included the baseline measure as covariate and the study center and treatment as main effects.|ANCOVA||Model based estimate|Analysis at Week 10||0.44|-2.49|0.169
71037668|NCT01438060|141582440|SUPERIORITY_OR_OTHER||Response ratio|0.79||||0.391|TWO_SIDED|95.0|0.47|1.35|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test with controlling for treatment and study center||Analysis at Week 1||1.35|0.47|0.391
71037669|NCT01438060|141582440|SUPERIORITY_OR_OTHER||Response ratio|0.95||||0.766|TWO_SIDED|95.0|0.69|1.31|||Cochran-Mantel-Haenszel|CMH test with controlling for treatment and study center||Analysis at Week 2||1.31|0.69|0.766
71037670|NCT01438060|141582440|SUPERIORITY_OR_OTHER||Response ratio|1.01||||0.967|TWO_SIDED|95.0|0.76|1.32||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at Week 3||1.32|0.76|0.967
71037671|NCT01438060|141582440|SUPERIORITY_OR_OTHER||Response ratio|0.92||||0.505|TWO_SIDED|95.0|0.71|1.19||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at Week 4||1.19|0.71|0.505
71037672|NCT01438060|141582440|SUPERIORITY_OR_OTHER||Response ratio|1.07||||0.59|TWO_SIDED|95.0|0.84|1.36||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at Week 6||1.36|0.84|0.590
71037673|NCT01438060|141582440|SUPERIORITY_OR_OTHER||Response ratio|1.1||||0.374|TWO_SIDED|95.0|0.89|1.37||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at Week 8||1.37|0.89|0.374
71037674|NCT01438060|141582440|SUPERIORITY_OR_OTHER||Response ratio|1.15||||0.175|TWO_SIDED|95.0|0.94|1.41||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at Week 10||1.41|0.94|0.175
71097873|NCT05894564|141704138|OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.79|1.26|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.26|0.79|
71097874|NCT05894564|141704138|OTHER||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.64|1.01|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.01|0.64|
71097875|NCT05894564|141704139|SUPERIORITY|Posterior probability of efficacy (P(Difference in MTU (Active - Placebo)\<0))|Difference in model estimate time unwell|-0.17|||||TWO_SIDED|95.0|-0.56|0.26|||||The mean time unwell is estimated from receipt of study drug to study day 14. The interval is a highest density credible interval.|No hypothesis test or decision rule was evaluated.||0.26|-0.56|
71097876|NCT05894564|141704140|SUPERIORITY|Posterior probability of efficacy (P(Difference days benefit (Active - Placebo)\>0))|Difference in model estimated means|0.21|||||TWO_SIDED|95.0|-0.29|0.68|||||The interval is a highest density credible interval.|Analysis is exploratory. No hypothesis test or decision rule was evaluated.||0.68|-0.29|
71097877|NCT03882801|141704141|SUPERIORITY||Least Square Geometric Means Ratio|0.92|||||TWO_SIDED|90.0|0.73|1.17|||||Back transformed least squares mean and confidence interval from linear mixed effects model performed on natural log-transformed values.|||1.17|0.73|
70985590|NCT01845077|141480863|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|107.7|||||TWO_SIDED|90.0|92.5|125.4|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||125.4|92.5|
71037675|NCT01438060|141582441|SUPERIORITY_OR_OTHER||Response ratio|0.88||||0.753|TWO_SIDED|95.0|0.41|1.92||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 1||1.92|0.41|0.753
71037676|NCT01438060|141582441|SUPERIORITY_OR_OTHER||Response ratio|0.9||||0.6|TWO_SIDED|95.0|0.62|1.32||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 2||1.32|0.62|0.600
71037677|NCT01438060|141582441|SUPERIORITY_OR_OTHER||Response ratio|0.93||||0.673|TWO_SIDED|95.0|0.65|1.31||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 3||1.31|0.65|0.673
71037678|NCT01438060|141582441|SUPERIORITY_OR_OTHER||Response ratio|0.83||||0.255|TWO_SIDED|95.0|0.6|1.14||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 4||1.14|0.60|0.255
71097878|NCT03548415|141704154|SUPERIORITY|||||||0.306||||||The p-value was analyzed using the nonparametric test, Van Elteren test with IGF-1 level as stratification factor.|Van Elteren test|||||||0.306
70985591|NCT00394914|141480864|SUPERIORITY_OR_OTHER|||||||0.973|||||||Cochran-Mantel-Haenszel|||||||0.973
70985592|NCT00394914|141480865|SUPERIORITY_OR_OTHER|||||||0.425|||||||Cochran-Mantel-Haenszel|||||||0.425
70985593|NCT00872898|141480889|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.2||||0.1197|TWO_SIDED|95.0|-4.9|0.6|||mixed-model for repeated measures|||||0.6|-4.9|0.1197
70985594|NCT00872898|141480890|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.1||||0.9781|TWO_SIDED|95.0|-7.2|7.0|||mixed-model for repeated measures|||||7.0|-7.2|0.9781
70985595|NCT00872898|141480891|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.4||||0.1459|TWO_SIDED|95.0|-3.2|0.5|||mixed-model for repeated measures|||||0.5|-3.2|0.1459
70985596|NCT00872898|141480892|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.8||||0.1344|TWO_SIDED|95.0|-1.9|0.3|||mixed-model for repeated measures|||||0.3|-1.9|0.1344
70985597|NCT00872898|141480893|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.2||||0.7|TWO_SIDED|95.0|-1.5|1.0|||mixed-model for repeated measures|||||1.0|-1.5|0.7000
70985598|NCT00872898|141480894|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.1||||0.9069|TWO_SIDED|95.0|-1.3|1.1|||mixed-model for repeated measures|||||1.1|-1.3|0.9069
70985599|NCT00872898|141480895|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.3||||0.4679|TWO_SIDED|95.0|-1.2|0.6|||mixed-model for repeated measures|||||0.6|-1.2|0.4679
70985600|NCT00872898|141480896|SUPERIORITY_OR_OTHER||Least squares mean difference|0.0||||0.9598|TWO_SIDED|95.0|-1.3|1.3|||mixed-model for repeated measures|||||1.3|-1.3|0.9598
70985601|NCT00872898|141480897|SUPERIORITY_OR_OTHER||Least squares mean difference|0.0||||0.9898|TWO_SIDED|95.0|-1.3|1.3|||mixed-model for repeated measures|||||1.3|-1.3|0.9898
70985602|NCT00872898|141480898|SUPERIORITY_OR_OTHER||Least squares mean difference|0.5||||0.4228|TWO_SIDED|95.0|-0.7|1.6|||mixed-model for repeated measures|||||1.6|-0.7|0.4228
70985603|NCT00872898|141480899|SUPERIORITY_OR_OTHER||Least squares mean difference|1.4||||0.0201|TWO_SIDED|95.0|0.2|2.5|||mixed-model for repeated measures|||||2.5|0.2|0.0201
70985604|NCT00872898|141480900|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.2||||0.6889|TWO_SIDED|95.0|-1.3|0.9|||mixed-model for repeated measures|||||0.9|-1.3|0.6889
70985605|NCT00872898|141480901|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2||||0.7481|TWO_SIDED|95.0|-0.9|1.2|||mixed-model for repeated measures|||||1.2|-0.9|0.7481
70985606|NCT00872898|141480902|SUPERIORITY_OR_OTHER||Least squares mean difference|0.0||||0.95|TWO_SIDED|95.0|-1.2|1.1|||mixed-model for repeated measures|||||1.1|-1.2|0.9500
70985607|NCT00044044|141480903|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
70985608|NCT00044044|141480904|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
70985609|NCT00044044|141480905|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
70985610|NCT00044044|141480906|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
70985611|NCT02179398|141480907|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|95.0|||||Chi-squared|||||||1
70985612|NCT02179398|141480908|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|95.0|||||Chi-squared|||||||1
70985613|NCT02179398|141480909|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED|95.0|||||Chi-squared|||Power calculation suggested 97 patients should be enrolled in each group to give 80% power at the 5% level of significance to detect a 20% difference in antibiotic prescription rate||||0.810
70985614|NCT01520922|141480974|SUPERIORITY_OR_OTHER||Percentage of participants|95.0|||||TWO_SIDED|95.0|84.53|99.44|||||The estimated value represents the percentage of participants with OR (CR+CRi+nPR+PR) while receiving ofatumumab + bendamustine 90 mg/m\^2.|||99.44|84.53|
70985615|NCT01520922|141480974|SUPERIORITY_OR_OTHER||Percentage of participants|74.0|||||TWO_SIDED|95.0|59.67|84.74|||||The estimated value represents the percentage of participants with OR (CR+CRi+nPR+PR) while receiving ofatumumab + bendamustine 70 mg/m\^2.|||84.74|59.67|
70985616|NCT04036136|141481002|EQUIVALENCE|The equivalence margin is 0.|Mean Difference (Final Values)|-0.36||||0.724|TWO_SIDED|95.0|-2.41|1.68|||ANCOVA|||Model covariates are Baseline SHAPS, age, and sex.||1.68|-2.41|0.724
70985617|NCT04036136|141481003|EQUIVALENCE|The equivalence margin is 0.|Mean Difference (Final Values)|-0.043||||0.292|TWO_SIDED|95.0|-0.124|0.038|||Regression, Linear|||Model covariates are Baseline fMRI, age, and sex.||0.038|-0.124|0.292
70985618|NCT04036136|141481004|EQUIVALENCE|The equivalence margin is 0.|Median Difference (Final Values)|-0.148||||0.084|TWO_SIDED|95.0|-0.316|0.02||The equivalence margin is 0.|Regression, Linear|||Model covariates are Baseline fMRI, age, and sex.||0.020|-0.316|0.084
70985619|NCT00336492|141481079|SUPERIORITY_OR_OTHER|||||||0.146|||||||Chi-squared|||||||0.146
70985620|NCT00227877|141481080|SUPERIORITY||Adjusted Relative Risk Ratio|1.39|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED|95.0|1.08|1.8|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Cessation)/(Control Cessation) controlling for age; gender; parent education; number of parents in home; visit type; perceived parent, sibling, and peer substance use; provider gender; and connectedness to provider.|||1.80|1.08|< 0.05
71037679|NCT01438060|141582441|SUPERIORITY_OR_OTHER||Response ratio|0.99||||0.958|TWO_SIDED|95.0|0.74|1.33||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 6||1.33|0.74|0.958
71037680|NCT01438060|141582441|SUPERIORITY_OR_OTHER||Response ratio|0.92||||0.525|TWO_SIDED|95.0|0.71|1.19||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 8||1.19|0.71|0.525
71097879|NCT01260324|141704188|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.01|||||TWO_SIDED|95.0|0.01|0.01|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age 18 to 34||0.01|0.01|
71097880|NCT01260324|141704188|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.01|||||TWO_SIDED|95.0|0.01|0.01|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age 35 to 44||0.01|0.01|
71097881|NCT01260324|141704188|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.03|||||TWO_SIDED|95.0|0.03|0.04|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age 45 to 54||0.04|0.03|
71097882|NCT01260324|141704188|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.08|||||TWO_SIDED|95.0|0.07|0.09|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age 55 to 64||0.09|0.07|
70985621|NCT00227877|141481081|SUPERIORITY||Adjusted Relative Risk Ratio|0.7|STANDARD_ERROR_OF_MEAN|0.25||0.32|TWO_SIDED|95.0|0.34|1.42|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Initiation)/(Control Initiation) controlling for age; gender; parent education; number of parents in home; visit type; perceived parent, sibling, and peer substance use; provider gender; and connectedness to provider.|||1.42|0.34|.32
70985622|NCT00227877|141481082|SUPERIORITY||Adjusted Relative Risk Ratio|1.8|STANDARD_ERROR_OF_MEAN|0.55||0.05|TWO_SIDED|95.0|0.99|3.27|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|||Risk Ratio: (Intervention Cessation)/(Control Cessation) controlling for age; gender; parent education; number of parents in home; visit type; perceived parent, sibling, and peer substance use; provider gender; and connectedness to provider.|3.27|.99|0.05
70985623|NCT00227877|141481083|SUPERIORITY||Adjusted Relative Risk Ratio|0.79|STANDARD_ERROR_OF_MEAN|0.16||0.23|TWO_SIDED|95.0|0.53|1.16|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Initiation)/(Control Initiation) controlling for age; gender; parent education; number of parents in home; visit type; perceived parent, sibling, and peer substance use; provider gender; and connectedness to provider.|||1.16|.53|0.23
70985624|NCT00227877|141481084|SUPERIORITY||Adjusted Relative Risk Ratio|1.52|STANDARD_ERROR_OF_MEAN|0.34||0.07|TWO_SIDED|95.0|0.97|2.36|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Cessation)/(Control Cessation) controlling for age and gender.|||2.36|.97|.07
71097883|NCT01260324|141704188|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.12|||||TWO_SIDED|95.0|0.11|0.14|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age 65 to 74||0.14|0.11|
71097884|NCT01260324|141704188|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.18|||||TWO_SIDED|95.0|0.15|0.21|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age ≥75||0.21|0.15|
70985625|NCT00227877|141481085|SUPERIORITY||Adjusted Relative Risk Ratio|0.96|STANDARD_ERROR_OF_MEAN|0.41||0.93|TWO_SIDED|95.0|0.42|2.21|||Regression, Logistic||Risk Ratio: (Intervention Initiation)/(Control Initiation) controlling for age and gender.|||2.21|.42|.93
70985626|NCT00227877|141481086|SUPERIORITY||Adjusted Relative Risk Ratio|0.85|STANDARD_ERROR_OF_MEAN|0.5||0.78|TWO_SIDED|95.0|0.27|2.7|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Cessation)/(Control Cessation) controlling for age and gender.|||2.70|.27|.78
70985627|NCT00227877|141481087|SUPERIORITY||Adjusted Relative Risk Ratio|0.74|STANDARD_ERROR_OF_MEAN|0.15||0.13|TWO_SIDED|95.0|0.51|1.09|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Initiation)/(Control Initiation) controlling for age and gender.|||1.09|.51|.13
70985628|NCT00227877|141481088|SUPERIORITY||Adjusted Relative Risk Ratio|0.66|STANDARD_ERROR_OF_MEAN|0.11||0.66|TWO_SIDED|95.0|0.48|0.91|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention)/(Control) controlling for age; gender; parent education; number of parents in home; visit type; provider gender; connectedness to provider, and baseline DRWI risk.|||.91|.48|.66
71097885|NCT01260324|141704188|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.09|||||TWO_SIDED|95.0|0.06|0.13|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Age 18 to 34||0.13|0.06|
71097886|NCT01260324|141704188|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.11|||||TWO_SIDED|95.0|0.08|0.16|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Age 35 to 44||0.16|0.08|
71097887|NCT01260324|141704188|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.37|||||TWO_SIDED|95.0|0.3|0.45|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Age 45 to 54||0.45|0.30|
70985629|NCT00227877|141481089|SUPERIORITY||Adjusted Relative Risk Ratio|0.87|STANDARD_ERROR_OF_MEAN|0.13||0.35|TWO_SIDED|95.0|0.64|1.17||Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Regression, Logistic||Risk Ratio: (Intervention)/(Control) controlling for age; gender; parent education; number of parents in home; visit type; provider gender; connectedness to provider, and baseline DRWI risk.|||1.17|.64|.35
71097888|NCT01260324|141704188|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.83|||||TWO_SIDED|95.0|2.68|5.47|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Age 65 to 74||5.47|2.68|
71097889|NCT01260324|141704188|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.73|||||TWO_SIDED|95.0|4.0|8.22|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Age ≥75||8.22|4.00|
70985630|NCT00227877|141481090|SUPERIORITY||Adjusted Relative Risk Ratio|0.63|STANDARD_ERROR_OF_MEAN|0.1|<|0.01|TWO_SIDED|95.0|0.46|0.87|||Regression, Logistic||Risk Ratio: (Intervention)/(Control) controlling for age; gender; connectedness to provider, and baseline DRWI risk.|||.87|.46|<.01
70985631|NCT00227877|141481091|SUPERIORITY||Adjusted Relative Risk Ratio|0.73|STANDARD_ERROR_OF_MEAN|0.11|<|0.05|TWO_SIDED|95.0|0.54|0.98|||Regression, Logistic||Risk Ratio: (Intervention)/(Control) controlling for age; gender; connectedness to provider, and baseline DRWI risk.|||.98|.54|< 0.05
70985632|NCT02026908|141481098|OTHER|Paired T- test|p value|0.05||||0.0001|TWO_SIDED|0.0||||P value was calculated with threshold of significance \<0.05.|t-test, 2 sided||A p-value was calculated. Pretreatment (baseline) values for each parameter are compared to post-treatment values in a paired fashion.|||||0.0001
70985633|NCT02026908|141481099|OTHER|Paired t test|p value|0.05||||0.0001|TWO_SIDED|0.0||||P value was calculated and a value of \<0.05 was considered significant. A p-value was calculated. Comments: Pretreatment (baseline) values for each parameter are compared to post-treatment values in a paired fashion.|t-test, 2 sided||P value was calculated with threshold of significance \<0.05.|||||0.0001
70985634|NCT02026908|141481100|OTHER|Paired T test|p value|0.05||||0.0001|TWO_SIDED|0.0||||P value was calculated and a value of \<0.05 was considered significant. A p-value was calculated. Comments: Pretreatment (baseline) values for each parameter are compared to post-treatment values in a paired fashion.|t-test, 2 sided||P value was calculated with threshold of significance \<0.05.|||||0.0001
70985635|NCT02026908|141481101|OTHER|Paired T Test|p value|0.05||||0.0001|TWO_SIDED|||||P value was calculated and a value of \<0.05 was considered significant. A p-value was calculated. Comments: Pretreatment (baseline) values for each parameter are compared to post-treatment values in a paired fashion.|t-test, 2 sided|||||||0.0001
70985636|NCT02026908|141481102|OTHER|Paired T test|p value|0.05||||0.008|TWO_SIDED|0.0||||P value was calculated and a value of \<0.05 was considered significant. A p-value was calculated. Comments: Pretreatment (baseline) values for each parameter are compared to post-treatment values in a paired fashion.|t-test, 2 sided||P value was calculated and a value of \<0.05 was considered significant. A p-value was calculated. Comments: Pretreatment (baseline) values for each parameter are compared to post-treatment values in a paired fashion.|||||0.008
70985637|NCT01543490|141481109|SUPERIORITY|Statistical hypotheses testing for the primary efficacy endpoint was 2-sided and performed using a significance (alpha) level of 0.05.|Risk Difference (RD)|8.5|STANDARD_ERROR_OF_MEAN|4.03||0.0354|TWO_SIDED|95.0|0.2|16.6||The p-value was from a 2-sided Fisher's exact test.|Fisher Exact|The point estimate of treatment effect (ISV-305 compared with Vehicle) was reported using Fisher's exact test.|The risk difference was obtained by taking the difference in proportions (ISV-305 minus Vehicle). A 2-sided exact unconditional 95% confidence interval (CI) was calculated.|||16.6|0.2|0.0354
70985638|NCT01543490|141481110|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoint was 2-sided and performed using a significance (alpha) level of 0.05, and missing data imputed using the LOCF approach.|Risk Difference (RD)|7.1|STANDARD_ERROR_OF_MEAN|4.07||0.1036|TWO_SIDED|95.0|-1.3|15.0||The p-value was from a 2-sided Fisher's exact test.|Fisher Exact|The point estimate of treatment effect (ISV-305 compared with Vehicle) was reported using Fisher's exact test.|The risk difference was obtained by taking the difference in proportions (ISV-305 minus Vehicle). A 2-sided exact unconditional 95% CI was calculated.|||15.0|-1.3|0.1036
71097890|NCT01260324|141704189|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.04|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Female||0.05|0.04|
71097891|NCT01260324|141704189|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.05|0.06|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Male||0.06|0.05|
71097892|NCT01260324|141704189|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.83|||||TWO_SIDED|95.0|1.5|2.22|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Male||2.22|1.50|
71097893|NCT01260324|141704190|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Year 2003||0.05|0.04|
71097894|NCT01260324|141704190|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Year 2004||0.05|0.04|
71097895|NCT01260324|141704190|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Year 2005||0.05|0.04|
70985639|NCT03918642|141481111|SUPERIORITY||Mean Difference (Net)|-1.59|||<|0.001|TWO_SIDED|95.0|-2.35|-0.83|||Mixed Models Analysis|||||-0.83|-2.35|<0.001
70985640|NCT03918642|141481112|SUPERIORITY||Mean Difference (Net)|-1.01||||0.01|TWO_SIDED|95.0|-1.78|-0.24|||Mixed Models Analysis|||||-0.24|-1.78|0.01
70985641|NCT03918642|141481113|SUPERIORITY||Mean Difference (Net)|0.28|||<|0.001|TWO_SIDED|95.0|0.12|0.45|||Mixed Models Analysis|||||0.45|0.12|<0.001
70985642|NCT03918642|141481114|SUPERIORITY||Mean Difference (Net)|-1.42||||0.14|TWO_SIDED|95.0|-3.3|0.46|||Mixed Models Analysis|||||0.46|-3.30|0.14
70985643|NCT03918642|141481115|SUPERIORITY||Mean Difference (Net)|0.21||||0.85|TWO_SIDED|95.0|-1.99|2.42|||Mixed Models Analysis|||||2.42|-1.99|0.85
70985644|NCT03918642|141481116|SUPERIORITY||Mean Difference (Net)|-3.06||||0.03|TWO_SIDED|95.0|-5.88|-0.25|||Mixed Models Analysis|||||-0.25|-5.88|0.03
70985645|NCT03918642|141481117|SUPERIORITY||Mean Difference (Net)|-2.39||||0.02|TWO_SIDED|95.0|-4.33|-0.45|||Mixed Models Analysis|||||-0.45|-4.33|0.02
71097896|NCT01260324|141704190|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.04|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Year 2006||0.05|0.04|
70985646|NCT03918642|141481118|SUPERIORITY||Mean Difference (Net)|-2.49||||0.006|TWO_SIDED|95.0|-4.3|-0.68|||Mixed Models Analysis|||||-0.68|-4.30|0.006
70985647|NCT03918642|141481119|SUPERIORITY||Mean Difference (Net)|-1.95||||0.11|TWO_SIDED|95.0|-4.34|0.45|||Mixed Models Analysis|||||0.45|-4.34|0.11
70985648|NCT03918642|141481120|SUPERIORITY||Mean Difference (Net)|-4.39||||0.03|TWO_SIDED|95.0|-8.44|-0.34|||Mixed Models Analysis|||||-0.34|-8.44|0.03
70985649|NCT03918642|141481121|SUPERIORITY||Mean Difference (Net)|-3.76||||0.07|TWO_SIDED|95.0|-7.83|0.32|||Mixed Models Analysis|||||0.32|-7.83|0.07
70985650|NCT03918642|141481122|SUPERIORITY||Mean Difference (Net)|1.23||||0.005|TWO_SIDED|95.0|0.36|2.1|||Mixed Models Analysis|||||2.10|0.36|0.005
70985651|NCT03918642|141481123|SUPERIORITY||Mean Difference (Net)|0.95||||0.17|TWO_SIDED|95.0|-0.4|2.29|||Mixed Models Analysis|||||2.29|-0.40|0.17
70985652|NCT03918642|141481124|SUPERIORITY||Mean Difference (Net)|-1.85||||0.11|TWO_SIDED|95.0|-4.14|0.44|||Mixed Models Analysis|||||0.44|-4.14|0.11
70985653|NCT03918642|141481125|SUPERIORITY||Mean Difference (Net)|-2.57||||0.11|TWO_SIDED|95.0|-5.73|0.6|||Mixed Models Analysis|||||0.60|-5.73|0.11
70985654|NCT03918642|141481126|SUPERIORITY||Mean Difference (Net)|-0.78||||0.33|TWO_SIDED|95.0|-2.33|0.78|||Mixed Models Analysis|||||0.78|-2.33|0.33
70985655|NCT03918642|141481127|SUPERIORITY||Mean Difference (Net)|-0.3||||0.69|TWO_SIDED|95.0|-1.74|1.14|||Mixed Models Analysis|||||1.14|-1.74|0.69
70985656|NCT03918642|141481128|SUPERIORITY||Mean Difference (Net)|1.46|||<|0.001|TWO_SIDED|95.0|0.77|2.15|||Mixed Models Analysis|||||2.15|0.77|<0.001
70985657|NCT03918642|141481129|SUPERIORITY||Mean Difference (Net)|1.24|||<|0.001|TWO_SIDED|95.0|0.62|1.86|||Mixed Models Analysis|||||1.86|0.62|<0.001
70985658|NCT03918642|141481130|SUPERIORITY||Odds Ratio (OR)|21.54|||<|0.001|TWO_SIDED|95.0|4.66|99.56|||Mixed Models Analysis|||||99.56|4.66|<0.001
70985659|NCT03918642|141481131|SUPERIORITY||Odds Ratio (OR)|7.24||||0.006|TWO_SIDED|95.0|1.74|30.06|||Mixed Models Analysis|||||30.06|1.74|0.006
70985660|NCT03918642|141481132|SUPERIORITY||Odds Ratio (OR)|11.77||||0.002|TWO_SIDED|95.0|2.38|58.25|||Mixed Models Analysis|||||58.25|2.38|0.002
70985661|NCT03918642|141481133|SUPERIORITY||Odds Ratio (OR)|6.58||||0.05|TWO_SIDED|95.0|0.99|43.67|||Mixed Models Analysis|||||43.67|0.99|0.05
70985662|NCT03918642|141481134|SUPERIORITY||Odds Ratio (OR)|13.93||||0.06|TWO_SIDED|95.0|0.86|225.44|||Mixed Models Analysis|||||225.44|0.86|0.06
70985663|NCT03918642|141481135|SUPERIORITY||Odds Ratio (OR)|5.61||||0.22|TWO_SIDED|95.0|0.35|89.3|||Mixed Models Analysis|||||89.30|0.35|0.22
70985664|NCT04003155|141481168|SUPERIORITY||LSMean Difference|-1.87|STANDARD_ERROR_OF_MEAN|0.42|<|0.001||95.0|-2.69|-1.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Least squares Mean (LSM), Standard error (SE), Confidence interval (CI), Mixed model repeated measures (MMRM), Change from Baseline (CFB), Dependent variable (dv), Treatment (tr), Week (wk), Baseline (bl), Weight (wt)||-1.05|-2.69|<0.001
70985665|NCT04003155|141481168|SUPERIORITY||LSMean Difference|-2.07|STANDARD_ERROR_OF_MEAN|0.42|<|0.001||95.0|-2.89|-1.25||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-1.25|-2.89|<0.001
70985666|NCT04003155|141481168|SUPERIORITY|||||||0.012|||||||Hochberg|||||||0.012
70985667|NCT04003155|141481168|SUPERIORITY|||||||0.007|||||||Hochberg|||||||0.007
70985668|NCT04003155|141481169|SUPERIORITY||LSMean difference|-2.39|STANDARD_ERROR_OF_MEAN|0.44|<|0.001||95.0|-3.25|-1.52||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-1.52|-3.25|<0.001
70985669|NCT04003155|141481169|SUPERIORITY||LSMean Difference|-2.55|STANDARD_ERROR_OF_MEAN|0.43|<|0.001||95.0|-3.4|-1.7||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-1.70|-3.40|<0.001
70985670|NCT04003155|141481169|SUPERIORITY|||||||0.012|||||||Hochberg|||||||0.012
70985671|NCT04003155|141481169|SUPERIORITY|||||||0.007|||||||Hochberg|||||||0.007
71037681|NCT01438060|141582441|SUPERIORITY_OR_OTHER||Response ratio|1.07||||0.602|TWO_SIDED|95.0|0.82|1.4||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 10||1.40|0.82|0.602
71037682|NCT01438060|141582445|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 1||||0.133
71037683|NCT01438060|141582445|SUPERIORITY_OR_OTHER|||||||0.282||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 2||||0.282
71037684|NCT01438060|141582445|SUPERIORITY_OR_OTHER|||||||0.571||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 3||||0.571
71037685|NCT01438060|141582445|SUPERIORITY_OR_OTHER|||||||0.895||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 4||||0.895
71037686|NCT01438060|141582445|SUPERIORITY_OR_OTHER|||||||0.817||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 6||||0.817
71037687|NCT01438060|141582445|SUPERIORITY_OR_OTHER|||||||0.795||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 8||||0.795
71037688|NCT01438060|141582445|SUPERIORITY_OR_OTHER|||||||0.564||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 10||||0.564
71037689|NCT01438060|141582447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.733|TWO_SIDED|95.0|-1.08|1.54|||ANCOVA|||Analysis at baseline||1.54|-1.08|0.733
71037690|NCT01438060|141582447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35||||0.001|TWO_SIDED|95.0|-2.16|-0.54|||ANOVA|||Analysis at Week 10||-0.54|-2.16|0.001
71037691|NCT00834405|141582480|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-72 and Cmax.|Geometric Test/Ref Ratio x 100|106.0||||||90.0|98.0|114.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||114|98.0|
71037692|NCT00834405|141582481|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-72 and Cmax.|Geometric Test/Ref Ratio x 100|107.0||||||90.0|100.0|115.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||115|100|
71037693|NCT00957021|141582518|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||KSS Pain/Motion and Function Score comparison from pre-op to 1, 2 and 5 year||||<.0001
71037694|NCT00957021|141582519|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||SF-36 Physical score comparison from pre-op to 1, 2, 3, 4 and 5 years||||<.0001
71037695|NCT00957021|141582519|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||SF-36 Mental score comparison from pre-op to 1 year||||<.0001
71037696|NCT00957021|141582519|SUPERIORITY_OR_OTHER|||||||0.0017|||||||t-test, 2 sided|||SF-36 Mental score comparison from pre-op to 2 year||||0.0017
71037697|NCT00957021|141582519|SUPERIORITY_OR_OTHER|||||||0.0055|||||||t-test, 2 sided|||SF-36 Mental score comparison from pre-op to 3 year||||0.0055
71037698|NCT00957021|141582519|SUPERIORITY_OR_OTHER|||||||0.005|||||||t-test, 2 sided|||SF-36 Mental score comparison from pre-op to 4 year||||0.0050
71037699|NCT00957021|141582519|SUPERIORITY_OR_OTHER|||||||0.0018|||||||t-test, 2 sided|||SF-36 Mental score comparison from pre-op to 5 year||||0.0018
71097897|NCT01260324|141704190|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Year 2007||0.05|0.04|
71037700|NCT00957021|141582521|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||LEAS score comparison from pre-op to 1, 2, 3, 4 and 5 years||||<.0001
71037701|NCT01822119|141582525|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation|||||||<0.0001
71037702|NCT01822119|141582526|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation|||||||<0.0001
71037703|NCT01822119|141582527|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Statistically significant changes with the same value at 500 to 4000Hz||||<0.0001
71037704|NCT01822119|141582527|SUPERIORITY_OR_OTHER|||||||0.0499|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Change at 6000Hz||||0.0499
71037705|NCT01822119|141582527|SUPERIORITY_OR_OTHER|||||||0.0632|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Change at 8000Hz||||0.0632
71037706|NCT01822119|141582528|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||||||0.39
71037707|NCT01822119|141582529|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||500Hz||||0.79
71037708|NCT01822119|141582529|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||1000Hz||||0.26
71037709|NCT01822119|141582529|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||2000Hz||||0.24
71037710|NCT01822119|141582529|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||3000Hz||||0.83
71037711|NCT01822119|141582529|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||4000Hz||||0.026
71037712|NCT01822119|141582529|SUPERIORITY_OR_OTHER|||||||0.0085|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6000Hz||||0.0085
71037713|NCT01822119|141582529|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||8000Hz||||0.13
71037714|NCT01822119|141582530|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Statistically significant improvement with the same value at all presentation levels.||||<0.0001
71037715|NCT01822119|141582531|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||50dB||||0.55
71037716|NCT01822119|141582531|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||60dB||||0.72
71037717|NCT01822119|141582531|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||80dB||||0.28
71037718|NCT01822119|141582532|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||||||<0.0001
71037719|NCT01822119|141582533|SUPERIORITY_OR_OTHER|||||||0.0092|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||||||0.0092
71037720|NCT01822119|141582534|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Aversiveness||||0.59
71097898|NCT01260324|141704190|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.61|0.96|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Year 2004||0.96|0.61|
71037721|NCT01822119|141582534|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Ease of Communication||||0.71
71037722|NCT01822119|141582534|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Reverberation||||0.59
71037723|NCT01822119|141582534|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Background noise||||0.40
71037724|NCT01822119|141582534|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Global score||||0.50
71037725|NCT05604209|141582556|SUPERIORITY||Median log2 fold change|1.63|||<|0.001|TWO_SIDED|95.0|0.67|2.14|||Wilcoxon (Mann-Whitney)|Within-group log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-1 from baseline to day 35 within all vaccinees is zero.||2.14|0.67|<0.001
71037726|NCT05604209|141582556|SUPERIORITY||median log2 fold change|1.15||||0.008|TWO_SIDED|95.0|0.09|2.59|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-1 from baseline to day 35 within the C62-M4 vaccinated arm is zero.||2.59|0.09|0.008
71037727|NCT05604209|141582556|SUPERIORITY||Median log2 fold change|1.66||||0.008|TWO_SIDED|95.0|0.93|4.59|||Wilcoxon (Mann-Whitney)|Within-am log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-1 from baseline to day 35 within the C1C62-M3M4 vaccinated arm is zero.||4.59|0.93|0.008
71097899|NCT01260324|141704190|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.58|0.91|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Year 2005||0.91|0.58|
70985672|NCT04003155|141481170|SUPERIORITY||LSMean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.06||0.012||95.0|-0.27|-0.03||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.03|-0.27|0.012
70985673|NCT04003155|141481170|SUPERIORITY||LSMean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.06||0.002||95.0|-0.3|-0.07||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.07|-0.30|0.002
70985674|NCT04003155|141481170|SUPERIORITY|||||||0.012|||||||Hochberg|||||||0.012
70985675|NCT04003155|141481170|SUPERIORITY|||||||0.007|||||||Hochberg|||||||0.007
70985676|NCT04003155|141481171|SUPERIORITY||LSMean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.08||0.002||95.0|-0.39|-0.09||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.09|-0.39|0.002
70985677|NCT04003155|141481171|SUPERIORITY||LSMean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.007||95.0|-0.35|-0.06||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.06|-0.35|0.007
70985678|NCT04003155|141481171|SUPERIORITY|||||||0.012|||||||Hochberg|||||||0.012
70985679|NCT04003155|141481171|SUPERIORITY|||||||0.007|||||||Hochberg|||||||0.007
70985680|NCT04003155|141481172|SUPERIORITY||LSMean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.8||0.489||95.0|-2.0|1.0||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||1.0|-2.0|0.489
71037728|NCT05604209|141582556|SUPERIORITY|||||||0.279|||||||Wilcoxon (Mann-Whitney)|Between-arm comparisons in log2 fold changes were statistically assessed using a two-sided exact Wilcoxon rank-sum test.||The contrast is the magnitude of the T-cell response to Mosaic-1 from baseline to day 35 in C62-M4 versus C1C62-M3M4.The null hypothesis is that he distributions of the T-cell response to Mosaic-1 from pre-vaccination to day 35 are the same between the two vaccinated arms.||||0.279
71037729|NCT05604209|141582557|SUPERIORITY||Median log2 fold change|1.66|||<|0.001|TWO_SIDED|95.0|1.09|2.33|||Wilcoxon (Mann-Whitney)|Within-group log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-2 from baseline to day 35 within all vaccinees is zero.||2.33|1.09|<0.001
71037730|NCT05604209|141582557|SUPERIORITY||Median log2 fold change|1.79||||0.008|TWO_SIDED|95.0|0.59|3.4|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-2 from baseline to day 35 within the C62-M4 vaccinated arm is zero.||3.40|0.59|0.008
71037731|NCT05604209|141582557|SUPERIORITY||Median log2 fold change|1.66||||0.008|TWO_SIDED|95.0|0.94|3.09|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-2 from baseline to day 35 within the C1C62-M3M4 vaccinated arm is zero.||3.09|0.94|0.008
71037732|NCT05604209|141582557|SUPERIORITY|||||||0.878|||||||Wilcoxon (Mann-Whitney)|Between-arm comparisons in log2 fold changes were statistically assessed using a two-sided exact Wilcoxon rank-sum test.||The contrast is the magnitude of the T-cell response to Mosaic-2 from baseline to day 35 in C62-M4 versus C1C62-M3M4.The null hypothesis is that he distributions of the T-cell response to Mosaic-2 from pre-vaccination to day 35 are the same between the two vaccinated arms.||||0.878
70985681|NCT04003155|141481172|SUPERIORITY||LSMean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.7||0.155||95.0|-2.5|0.4||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||0.4|-2.5|0.155
71037733|NCT05604209|141582558|SUPERIORITY||Median log2 fold change|1.47|||<|0.001|TWO_SIDED|95.0|0.54|2.63|||Wilcoxon (Mann-Whitney)|Within-group log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-1 from baseline to day 42 within all vaccinees is zero.||2.63|0.54|<0.001
71037734|NCT05604209|141582558|SUPERIORITY||Median log2 fold change|1.09||||0.008|TWO_SIDED|95.0|0.39|3.61|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-1 from baseline to day 42 within the C62-M4 vaccinated arm is zero.||3.61|0.39|0.008
70985682|NCT04003155|141481173|SUPERIORITY||LSMean difference|-1.81|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.53|-1.09||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-1.09|-2.53|<0.001
70985683|NCT04003155|141481173|SUPERIORITY||LSMean Difference|-1.25|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-1.97|-0.53||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.53|-1.97|<0.001
70985684|NCT04003155|141481173|SUPERIORITY||LSMean Difference|-1.97|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.75|-1.19||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-1.19|-2.75|<0.001
70985685|NCT04003155|141481173|SUPERIORITY||LSMean Difference|-1.83|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-2.6|-1.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-1.05|-2.60|<0.001
70985686|NCT04003155|141481173|SUPERIORITY||LSMean Difference|-1.99|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-2.79|-1.19||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-1.19|-2.79|<0.001
70985687|NCT04003155|141481173|SUPERIORITY||LSMean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.9|-1.31||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-1.31|-2.90|<0.001
70985688|NCT04003155|141481173|SUPERIORITY||LSMean Difference|-2.07|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-2.87|-1.27||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-1.27|-2.87|<0.001
70985689|NCT04003155|141481173|SUPERIORITY||LSMean Difference|-2.18|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.98|-1.39||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-1.39|-2.98|<0.001
70985690|NCT04003155|141481173|SUPERIORITY||LSMean Difference|-2.11|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-2.92|-1.3||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-1.30|-2.92|<0.001
70985691|NCT04003155|141481173|SUPERIORITY||LSMean Difference|-2.39|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-3.19|-1.59||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-1.59|-3.19|<0.001
70985692|NCT04003155|141481173|SUPERIORITY||LSMean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-2.95|-1.25||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-1.25|-2.95|<0.001
71037735|NCT05604209|141582558|SUPERIORITY||Median log2 fold change|2.0||||0.016|TWO_SIDED|95.0|0.43|4.37|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-1 from baseline to day 42 within the C1C62-M3M4 vaccinated arm is zero.||4.37|0.43|0.016
71037736|NCT05604209|141582558|SUPERIORITY|||||||0.189|||||||Wilcoxon (Mann-Whitney)|Between-arm comparisons in log2 fold changes were statistically assessed using a two-sided exact Wilcoxon rank-sum test.||The contrast is the magnitude of the T-cell response to Mosaic-1 from baseline to day 42 in C62-M4 versus C1C62-M3M4.The null hypothesis is that he distributions of the T-cell response to Mosaic-1 from pre-vaccination to day 42 are the same between the two vaccinated arms.||||0.189
71037737|NCT05604209|141582559|SUPERIORITY||Median log2 fold change|1.78|||<|0.001|TWO_SIDED|95.0|0.81|2.51|||Wilcoxon (Mann-Whitney)|Within-group log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-2 from baseline to day 42 within all vaccinees is zero.||2.51|0.81|<0.001
71037738|NCT05604209|141582559|SUPERIORITY||Median log2 fold change|1.57||||0.008|TWO_SIDED|95.0|0.63|3.89|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-2 from baseline to day 42 within the C62-M4 vaccinated arm is zero.||3.89|0.63|0.008
71037739|NCT05604209|141582559|SUPERIORITY||Median log2 fold change|1.78||||0.016|TWO_SIDED|95.0|0.7|3.79|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-2 from baseline to day 42 within the C162-M3M4 vaccinated arm is zero.||3.79|0.70|0.016
71037740|NCT05604209|141582559|SUPERIORITY|||||||0.955|||||||Wilcoxon (Mann-Whitney)|Between-arm comparisons in log2 fold changes were statistically assessed using a two-sided exact Wilcoxon rank-sum test.||The contrast is the magnitude of the T-cell response to Mosaic-2 from baseline to day 42 in C62-M4 versus C1C62-M3M4.The null hypothesis is that he distributions of the T-cell response to Mosaic-2 from pre-vaccination to day 42 are the same between the two vaccinated arms.||||0.955
71037741|NCT05604209|141582560|SUPERIORITY||Median Difference (Net)|2.0||||0.125|TWO_SIDED|95.0|-1.0|4.0|||Wilcoxon (Mann-Whitney)|Within-group changes in breadth from baseline to day 56 were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median change in breadth of T-cell response to HIV-1 subpools from baseline to day 56 within all vaccinees is zero.||4|-1|0.125
70985693|NCT04003155|141481173|SUPERIORITY||LSMean Difference|-2.27|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.11|-1.42||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-1.42|-3.11|<0.001
70985694|NCT04003155|141481173|SUPERIORITY||LSMean Difference|-2.39|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.25|-1.54||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-1.54|-3.25|<0.001
70985695|NCT04003155|141481173|SUPERIORITY||LSMean Difference|-2.39|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.23|-1.55||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-1.55|-3.23|<0.001
70985696|NCT04003155|141481173|SUPERIORITY||LSMean Difference|-2.08|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-2.93|-1.22||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-1.22|-2.93|<0.001
70985697|NCT04003155|141481173|SUPERIORITY||LSMean Difference|-2.16|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.0|-1.31||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-1.31|-3.00|<0.001
70985698|NCT04003155|141481173|SUPERIORITY||LSMean Difference|-2.21|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.05|-1.37||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-1.37|-3.05|<0.001
70985699|NCT04003155|141481173|SUPERIORITY||LSMean Difference|-2.16|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-2.98|-1.33||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-1.33|-2.98|<0.001
70985700|NCT04003155|141481173|SUPERIORITY||LSMean Difference|-2.48|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED|95.0|-3.34|-1.62||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-1.62|-3.34|<0.001
70985701|NCT04003155|141481173|SUPERIORITY||LSMean Difference|-2.45|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.3|-1.6||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-1.60|-3.30|<0.001
70985702|NCT04003155|141481174|SUPERIORITY||LSMean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.006|TWO_SIDED|95.0|-0.17|-0.03||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.03|-0.17|0.006
70985703|NCT04003155|141481174|SUPERIORITY||LSMean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.006|TWO_SIDED|95.0|-0.17|-0.03||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.03|-0.17|0.006
70985704|NCT04003155|141481174|SUPERIORITY||LSMean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.05||0.003|TWO_SIDED|95.0|-0.24|-0.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-0.05|-0.24|0.003
70985705|NCT04003155|141481174|SUPERIORITY||LSMean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.05||0.002|TWO_SIDED|95.0|-0.25|-0.06||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-0.06|-0.25|0.002
70985706|NCT04003155|141481174|SUPERIORITY||LSMean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.06||0.004|TWO_SIDED|95.0|-0.27|-0.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-0.05|-0.27|0.004
70985707|NCT04003155|141481174|SUPERIORITY||LSMean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.003|TWO_SIDED|95.0|-0.28|-0.06||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-0.06|-0.28|0.003
70985708|NCT04003155|141481174|SUPERIORITY||LSMean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.006|TWO_SIDED|95.0|-0.29|-0.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-0.05|-0.29|0.006
70985709|NCT04003155|141481174|SUPERIORITY||LSMean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.004|TWO_SIDED|95.0|-0.29|-0.06||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-0.06|-0.29|0.004
71097900|NCT01260324|141704190|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.68|1.12|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Year 2006||1.12|0.68|
70985710|NCT04003155|141481174|SUPERIORITY||LSMean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.003|TWO_SIDED|95.0|-0.33|-0.07||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-0.07|-0.33|0.003
70985711|NCT04003155|141481174|SUPERIORITY||LSMean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.38|-0.13||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-0.13|-0.38|<0.001
70985712|NCT04003155|141481174|SUPERIORITY||LSMean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.37|-0.11||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-0.11|-0.37|<0.001
70985713|NCT04003155|141481174|SUPERIORITY||LSMean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.39|-0.13||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-0.13|-0.39|<0.001
70985714|NCT04003155|141481174|SUPERIORITY||LSMean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.41|-0.15||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-0.15|-0.41|<0.001
70985715|NCT04003155|141481174|SUPERIORITY||LSMean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.37|-0.11||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-0.11|-0.37|<0.001
70985716|NCT04003155|141481174|SUPERIORITY||MMRM|-0.26|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.41|-0.12||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-0.12|-0.41|<0.001
70985717|NCT04003155|141481174|SUPERIORITY||LSMean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.07||0.004|TWO_SIDED|95.0|-0.35|-0.06||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-0.06|-0.35|0.004
70985718|NCT04003155|141481174|SUPERIORITY||LSMean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.43|-0.13||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-0.13|-0.43|<0.001
70985719|NCT04003155|141481174|SUPERIORITY||LSMean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED|95.0|-0.37|-0.08||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-0.08|-0.37|0.002
70985720|NCT04003155|141481174|SUPERIORITY||LSMean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.43|-0.12||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-0.12|-0.43|<0.001
70985721|NCT04003155|141481174|SUPERIORITY||LSMean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.08||0.002|TWO_SIDED|95.0|-0.4|-0.09||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-0.09|-0.40|0.002
70985722|NCT04003155|141481175|SUPERIORITY||LSMean Difference|-15.52|STANDARD_ERROR_OF_MEAN|3.29|<|0.001|TWO_SIDED|95.0|-21.99|-9.06||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-9.06|-21.99|<0.001
70985723|NCT04003155|141481175|SUPERIORITY||LSMean Difference|-12.22|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-18.69|-5.74||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-5.74|-18.69|<0.001
70985724|NCT04003155|141481175|SUPERIORITY||LSMean Difference|-17.3|STANDARD_ERROR_OF_MEAN|3.57|<|0.001|TWO_SIDED|95.0|-24.32|-10.27||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-10.27|-24.32|<0.001
70985725|NCT04003155|141481175|SUPERIORITY||LSMean Difference|-18.29|STANDARD_ERROR_OF_MEAN|3.57|<|0.001|TWO_SIDED|95.0|-25.3|-11.29||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-11.29|-25.30|<0.001
70985726|NCT04003155|141481175|SUPERIORITY||LSMean Difference|-18.13|STANDARD_ERROR_OF_MEAN|3.63|<|0.001|TWO_SIDED|95.0|-25.25|-11.0||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-11.00|-25.25|<0.001
71097901|NCT01260324|141704190|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.72|1.19|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Year 2007||1.19|0.72|
70985727|NCT04003155|141481175|SUPERIORITY||LSMean Difference|-21.19|STANDARD_ERROR_OF_MEAN|3.61|<|0.001|TWO_SIDED|95.0|-28.29|-14.09||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-14.09|-28.29|<0.001
70985728|NCT04003155|141481175|SUPERIORITY||LSMean Difference|-16.75|STANDARD_ERROR_OF_MEAN|3.81|<|0.001|TWO_SIDED|95.0|-24.24|-9.26||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 4||-9.26|-24.24|<0.001
70985729|NCT04003155|141481175|SUPERIORITY||LSMean Difference|-21.05|STANDARD_ERROR_OF_MEAN|3.79|<|0.001|TWO_SIDED|95.0|-28.5|-13.61||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 4||-13.61|-28.50|<0.001
70985730|NCT04003155|141481175|SUPERIORITY||LSMean Difference|-17.57|STANDARD_ERROR_OF_MEAN|3.79|<|0.001|TWO_SIDED|95.0|-25.02|-10.12||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-10.12|-25.02|<0.001
71097902|NCT01260324|141704191|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.04|0.06|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Northeast||0.06|0.04|
71097903|NCT01260324|141704191|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Midwest||0.05|0.04|
71097904|NCT01260324|141704191|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.05|0.06|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate South||0.06|0.05|
70985731|NCT04003155|141481175|SUPERIORITY||LSMean Difference|-21.78|STANDARD_ERROR_OF_MEAN|3.76|<|0.001|TWO_SIDED|95.0|-29.18|-14.39||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-14.39|-29.18|<0.001
70985732|NCT04003155|141481175|SUPERIORITY||LSMean Difference|-18.39|STANDARD_ERROR_OF_MEAN|3.89|<|0.001|TWO_SIDED|95.0|-26.03|-10.75||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-10.75|-26.03|<0.001
70985733|NCT04003155|141481175|SUPERIORITY||LSMean Difference|-23.83|STANDARD_ERROR_OF_MEAN|3.85|<|0.001|TWO_SIDED|95.0|-31.39|-16.27||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-16.27|-31.39|<0.001
70985734|NCT04003155|141481175|SUPERIORITY||LSMean Difference|-18.29|STANDARD_ERROR_OF_MEAN|4.09|<|0.001|TWO_SIDED|95.0|-26.33|-10.25||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-10.25|-26.33|<0.001
70985735|NCT04003155|141481175|SUPERIORITY||LSMean Difference|-21.41|STANDARD_ERROR_OF_MEAN|4.04|<|0.001|TWO_SIDED|95.0|-29.35|-13.48||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-13.48|-29.35|<0.001
71097905|NCT01260324|141704191|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.04|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate West||0.05|0.04|
70985736|NCT04003155|141481175|SUPERIORITY||LSMean Difference|-20.16|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-28.14|-12.19||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-12.19|-28.14|<0.001
70985737|NCT04003155|141481175|SUPERIORITY||LSMean Difference|-21.17|STANDARD_ERROR_OF_MEAN|4.01|<|0.001|TWO_SIDED|95.0|-29.04|-13.3||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-13.30|-29.04|<0.001
70985738|NCT04003155|141481175|SUPERIORITY||LSMean Difference|-16.67|STANDARD_ERROR_OF_MEAN|4.1|<|0.001|TWO_SIDED|95.0|-24.73|-8.61||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-8.61|-24.73|<0.001
70985739|NCT04003155|141481175|SUPERIORITY||LSMean Difference|-18.89|STANDARD_ERROR_OF_MEAN|4.05|<|0.001|TWO_SIDED|95.0|-26.84|-10.94||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-10.94|-26.84|<0.001
71097906|NCT01260324|141704191|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.41|||||TWO_SIDED|95.0|0.31|0.56|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Northeast||0.56|0.31|
70985740|NCT04003155|141481175|SUPERIORITY||LSMean Difference|-17.88|STANDARD_ERROR_OF_MEAN|4.01|<|0.001|TWO_SIDED|95.0|-25.77|-9.99||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-9.99|-25.77|<0.001
70985741|NCT04003155|141481175|SUPERIORITY||LSMean Difference|-19.5|STANDARD_ERROR_OF_MEAN|3.96|<|0.001|TWO_SIDED|95.0|-27.28|-11.72||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-11.72|-27.28|<0.001
70985742|NCT04003155|141481175|SUPERIORITY||LSMean Difference|-20.32|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-28.3|-12.35||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-12.35|-28.30|<0.001
70985743|NCT04003155|141481175|SUPERIORITY||LSMean Difference|-22.14|STANDARD_ERROR_OF_MEAN|4.0|<|0.001|TWO_SIDED|95.0|-30.0|-14.28||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-14.28|-30.00|<0.001
70985744|NCT04003155|141481175|SUPERIORITY||LSMean Difference|-20.08|STANDARD_ERROR_OF_MEAN|4.13|<|0.001|TWO_SIDED|95.0|-28.19|-11.96||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 12||-11.96|-28.19|<0.001
70985745|NCT04003155|141481175|SUPERIORITY||LSMean Difference|-24.18|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-32.16|-16.2||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 12||-16.20|-32.16|<0.001
70985746|NCT04003155|141481176|SUPERIORITY||Odds Ratio (OR)|3.245|||<|0.001|TWO_SIDED|95.0|1.823|5.999||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 1||5.999|1.823|<0.001
70985747|NCT04003155|141481176|SUPERIORITY||Odds Ratio (OR)|2.964|||<|0.001|TWO_SIDED|95.0|1.658|5.497||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 1||5.497|1.658|<0.001
70985748|NCT04003155|141481176|SUPERIORITY||Odds Ratio (OR)|2.187||||0.001|TWO_SIDED|95.0|1.363|3.549||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||3.549|1.363|0.001
70985749|NCT04003155|141481176|SUPERIORITY||Odds Ratio (OR)|2.847|||<|0.001|TWO_SIDED|95.0|1.786|4.601||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||4.601|1.786|<0.001
70985750|NCT04003155|141481176|SUPERIORITY||Odds Ratio (OR)|2.096||||0.002|TWO_SIDED|95.0|1.326|3.345||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||3.345|1.326|0.002
70985751|NCT04003155|141481176|SUPERIORITY||Odds Ratio (OR)|3.333|||<|0.001|TWO_SIDED|95.0|2.121|5.302||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||5.302|2.121|<0.001
70985752|NCT04003155|141481176|SUPERIORITY||Odds Ratio (OR)|2.061||||0.001|TWO_SIDED|95.0|1.323|3.233||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||3.233|1.323|0.001
70985753|NCT04003155|141481176|SUPERIORITY||Odds Ratio (OR)|3.025|||<|0.001|TWO_SIDED|95.0|1.947|4.746||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||4.746|1.947|<0.001
70985754|NCT04003155|141481176|SUPERIORITY||Odds Ratio (OR)|2.13|||<|0.001|TWO_SIDED|95.0|1.363|3.357||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||3.357|1.363|<0.001
70985755|NCT04003155|141481176|SUPERIORITY||Odds Ratio (OR)|3.223|||<|0.001|TWO_SIDED|95.0|2.067|5.08||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||5.080|2.067|<0.001
70985756|NCT04003155|141481176|SUPERIORITY||Odds Ratio (OR)|2.049||||0.002|TWO_SIDED|95.0|1.317|3.21||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||3.210|1.317|0.002
70985757|NCT04003155|141481176|SUPERIORITY||Odds Ratio (OR)|3.097|||<|0.001|TWO_SIDED|95.0|1.994|4.858||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||4.858|1.994|<0.001
71037742|NCT00112437|141582561|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|3.5|||<=|0.001|TWO_SIDED|95.0|2.54|4.45||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 12 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 12 months.||4.45|2.54|<=0.001
71037743|NCT00112437|141582561|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.78|||<=|0.001|TWO_SIDED|95.0|1.82|3.73||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 12 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 12 months.||3.73|1.82|<=0.001
71037744|NCT00112437|141582561|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.63||||0.003|TWO_SIDED|95.0|0.68|2.59||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 12 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 12 months.||2.59|0.68|0.003
71037745|NCT00112437|141582561|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.49||||0.343|TWO_SIDED|95.0|-1.44|0.46||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 12 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 12 months.||0.46|-1.44|0.343
71037746|NCT00112437|141582562|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|5.67|||<=|0.001|TWO_SIDED|95.0|4.32|7.02||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 24 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 24 months.||7.02|4.32|<=0.001
71097907|NCT01260324|141704191|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.68|||||TWO_SIDED|95.0|0.56|0.84|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Midwest||0.84|0.56|
71097908|NCT01260324|141704191|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.57|0.93|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio West||0.93|0.57|
71097909|NCT01260324|141704192|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.09|||||TWO_SIDED|95.0|0.08|0.1|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Diabetes||0.10|0.08|
71097910|NCT01260324|141704192|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.11|||||TWO_SIDED|95.0|0.08|0.14|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Smoking||0.14|0.08|
71097911|NCT01260324|141704192|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.04|||||TWO_SIDED|95.0|0.03|0.06|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Obesity||0.06|0.03|
71097912|NCT01260324|141704192|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.07|||||TWO_SIDED|95.0|0.06|0.09|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Nitrates||0.09|0.06|
71097913|NCT01260324|141704192|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.15|||||TWO_SIDED|95.0|0.12|0.18|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Anti-platelet agents||0.18|0.12|
71097914|NCT01260324|141704192|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.13|||||TWO_SIDED|95.0|0.09|0.17|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Diuretics||0.17|0.09|
71097915|NCT01260324|141704192|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.03|||||TWO_SIDED|95.0|0.01|0.04|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Recent PDE-5 inhibitors use||0.04|0.01|
71097916|NCT01260324|141704192|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.82|||||TWO_SIDED|95.0|1.47|2.25|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Diabetes||2.25|1.47|
71097917|NCT01260324|141704192|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|0.63|2.85|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Smoking||2.85|0.63|
71097918|NCT01260324|141704192|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.43|||||TWO_SIDED|95.0|0.23|0.81|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Obesity||0.81|0.23|
71097919|NCT01260324|141704192|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.63|||||TWO_SIDED|95.0|0.42|0.94|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Nitrates||0.94|0.42|
70985758|NCT04003155|141481176|SUPERIORITY||Odds Ratio (OR)|1.984||||0.002|TWO_SIDED|95.0|1.28|3.097||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||3.097|1.280|0.002
70985759|NCT04003155|141481176|SUPERIORITY||Odds Ratio (OR)|3.062|||<|0.001|TWO_SIDED|95.0|1.977|4.788||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||4.788|1.977|<0.001
71037747|NCT00112437|141582562|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|4.45|||<=|0.001|TWO_SIDED|95.0|3.15|5.76||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 24 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 24 months.||5.76|3.15|<=0.001
71037748|NCT00112437|141582562|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|3.39|||<=|0.001|TWO_SIDED|95.0|2.06|4.73||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 24 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 24 months.||4.73|2.06|<=0.001
71037749|NCT00112437|141582562|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-0.84||||0.218||95.0|-2.19|0.51||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 24 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 24 months.||0.51|-2.19|0.218
71037750|NCT00112437|141582563|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.49|||<=|0.001|TWO_SIDED|95.0|1.62|3.35||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 12 months.||3.35|1.62|<=0.001
71097920|NCT01260324|141704192|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.12|||||TWO_SIDED|95.0|1.53|2.94|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Anti-platelet agents||2.94|1.53|
71097921|NCT01260324|141704192|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.24|||||TWO_SIDED|95.0|1.46|3.43|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Diuretics||3.43|1.46|
71097922|NCT01260324|141704192|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.57|||||TWO_SIDED|95.0|0.31|1.04|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Recent PDE-5 inhibitors use||1.04|0.31|
71097923|NCT01260324|141704193|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.33|||||TWO_SIDED|95.0|0.28|0.39|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Other retinal disorders||0.39|0.28|
71097924|NCT01260324|141704193|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.13|||||TWO_SIDED|95.0|0.11|0.16|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Glaucoma||0.16|0.11|
71097925|NCT01260324|141704193|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.2|||||TWO_SIDED|95.0|0.08|0.41|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Cataract||0.41|0.08|
70985760|NCT04003155|141481176|SUPERIORITY||Odds Ratio (OR)|2.748|||<|0.001|TWO_SIDED|95.0|1.774|4.294||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||4.294|1.774|<0.001
71097926|NCT01260324|141704193|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.99|||||TWO_SIDED|95.0|0.83|1.17|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Visual disturbances||1.17|0.83|
71097927|NCT01260324|141704193|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|2.0|||||TWO_SIDED|95.0|1.6|2.46|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Blindness and low vision||2.46|1.60|
71097928|NCT01260324|141704193|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.19|||||TWO_SIDED|95.0|0.16|0.23|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Other disorders of eye||0.23|0.16|
70985761|NCT04003155|141481176|SUPERIORITY||Odds Ratio (OR)|2.379|||<|0.001|TWO_SIDED|95.0|1.536|3.712||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||3.712|1.536|<0.001
70985762|NCT04003155|141481176|SUPERIORITY||Odds Ratio (OR)|2.051||||0.001|TWO_SIDED|95.0|1.329|3.186||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||3.186|1.329|0.001
70985763|NCT04003155|141481176|SUPERIORITY||Odds Ratio (OR)|2.701|||<|0.001|TWO_SIDED|95.0|1.75|4.204||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||4.204|1.750|<0.001
70985764|NCT04003155|141481176|SUPERIORITY||Odds Ratio (OR)|2.725|||<|0.001|TWO_SIDED|95.0|1.742|4.306||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||4.306|1.742|<0.001
70985765|NCT04003155|141481176|SUPERIORITY||Odds Ratio (OR)|3.921|||<|0.001|TWO_SIDED|95.0|2.505|6.214||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||6.214|2.505|<0.001
70985766|NCT04003155|141481176|SUPERIORITY||Odds Ratio (OR)|2.104|||<|0.001|TWO_SIDED|95.0|1.363|3.27||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||3.270|1.363|<0.001
70985767|NCT04003155|141481176|SUPERIORITY||Odds Ratio (OR)|2.953|||<|0.001|TWO_SIDED|95.0|1.912|4.602||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||4.602|1.912|<0.001
70985768|NCT04003155|141481176|SUPERIORITY||Odds Ratio (OR)|1.894||||0.005|TWO_SIDED|95.0|1.22|2.961||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||2.961|1.220|0.005
70985769|NCT04003155|141481176|SUPERIORITY||Odds Ratio (OR)|3.156|||<|0.001|TWO_SIDED|95.0|2.035|4.944||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||4.944|2.035|<0.001
70985770|NCT04003155|141481177|SUPERIORITY||Odds Ratio (OR)|3.158||||0.322|TWO_SIDED|95.0|0.398|64.304||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||64.304|0.398|0.322
70985771|NCT04003155|141481177|SUPERIORITY||Odds Ratio (OR)|3.925||||0.225|TWO_SIDED|95.0|0.569|77.353||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||77.353|0.569|0.225
71097929|NCT01260324|141704193|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.22|||||TWO_SIDED|95.0|0.18|0.27|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Occlusion and stenosis of precerebral arteries||0.27|0.18|
70985772|NCT04003155|141481177|SUPERIORITY||Odds Ratio (OR)|6.334||||0.089|TWO_SIDED|95.0|1.064|120.422||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||120.422|1.064|0.089
70985773|NCT04003155|141481177|SUPERIORITY||Odds Ratio (OR)|5.026||||0.143|TWO_SIDED|95.0|0.797|96.916||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||96.916|0.797|0.143
70985774|NCT04003155|141481177|SUPERIORITY||Odds Ratio (OR)|1.257||||0.711|TWO_SIDED|95.0|0.37|4.468||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||4.468|0.370|0.711
70985775|NCT04003155|141481177|SUPERIORITY||Odds Ratio (OR)|1.57||||0.441|TWO_SIDED|95.0|0.508|5.328||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||5.328|0.508|0.441
70985776|NCT04003155|141481177|SUPERIORITY||Odds Ratio (OR)|5.351||||0.032|TWO_SIDED|95.0|1.383|35.172||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||35.172|1.383|0.032
70985777|NCT04003155|141481177|SUPERIORITY||Odds Ratio (OR)|3.059||||0.175|TWO_SIDED|95.0|0.693|21.086||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||21.086|0.693|0.175
70985778|NCT04003155|141481177|SUPERIORITY||Odds Ratio (OR)|4.225||||0.071|TWO_SIDED|95.0|1.039|28.29||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||28.290|1.039|0.071
70985779|NCT04003155|141481177|SUPERIORITY||Odds Ratio (OR)|5.22||||0.035|TWO_SIDED|95.0|1.348|34.323||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||34.323|1.348|0.035
70985780|NCT04003155|141481177|SUPERIORITY||Odds Ratio (OR)|7.064||||0.011|TWO_SIDED|95.0|1.912|45.64||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||45.640|1.912|0.011
70985781|NCT04003155|141481177|SUPERIORITY||Odds Ratio (OR)|6.949||||0.012|TWO_SIDED|95.0|1.881|44.892||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||44.892|1.881|0.012
70985782|NCT04003155|141481177|SUPERIORITY||Odds Ratio (OR)|5.344||||0.032|TWO_SIDED|95.0|1.381|35.134||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||35.134|1.381|0.032
70985783|NCT04003155|141481177|SUPERIORITY||Odds Ratio (OR)|7.514||||0.008|TWO_SIDED|95.0|2.055|48.354||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||48.354|2.055|0.008
70985784|NCT04003155|141481177|SUPERIORITY||Odds Ratio (OR)|3.238||||0.026|TWO_SIDED|95.0|1.222|10.148||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||10.148|1.222|0.026
70985785|NCT04003155|141481177|SUPERIORITY||Odds Ratio (OR)|3.438||||0.019|TWO_SIDED|95.0|1.311|10.714||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||10.714|1.311|0.019
70985786|NCT04003155|141481177|SUPERIORITY||Odds Ratio (OR)|2.626||||0.037|TWO_SIDED|95.0|1.101|6.951||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||6.951|1.101|0.037
70985787|NCT04003155|141481177|SUPERIORITY||Odds Ratio (OR)|2.758||||0.027|TWO_SIDED|95.0|1.167|7.263||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||7.263|1.167|0.027
70985788|NCT04003155|141481177|SUPERIORITY||Odds Ratio (OR)|1.69||||0.21|TWO_SIDED|95.0|0.753|3.968||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||3.968|0.753|0.210
70985789|NCT04003155|141481177|SUPERIORITY||Odds Ratio (OR)|2.01||||0.087|TWO_SIDED|95.0|0.923|4.634||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||4.634|0.923|0.087
70985790|NCT04003155|141481177|SUPERIORITY||Odds Ratio (OR)|2.1||||0.148|TWO_SIDED|95.0|0.795|6.157||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||6.157|0.795|0.148
70985791|NCT04003155|141481177|SUPERIORITY||Odds Ratio (OR)|3.262||||0.015|TWO_SIDED|95.0|1.329|9.194||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||9.194|1.329|0.015
70985792|NCT02778867|141481225|OTHER|||||||0.58||||||α \< 0.05|Fisher Exact|Two-sided||||||0.58
70985793|NCT02778867|141481226|OTHER|||||||0.06||||||α \< 0.05|Fisher Exact|Two sided||||||0.06
70985794|NCT02778867|141481229|OTHER|||||||0.9||||||α \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.90
70985795|NCT02778867|141481230|OTHER|||||||0.22||||||α \< 0.05|t-test, 2 sided|Two sample t-test||||||0.22
70985796|NCT02778867|141481231|OTHER|||||||0.71||||||α \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.71
70985797|NCT03504774|141481232|OTHER||Mean Difference (Net)|0.6||||0.3|TWO_SIDED||||||Mixed Models Analysis|||analysis of the change from baseline in CD28 expression||||0.30
70985798|NCT03504774|141481233|OTHER||Mean Difference (Net)|0.9||||0.82|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change from baseline to week 52||||0.82
70985799|NCT03504774|141481233|OTHER||Mean Difference (Net)|1.2||||0.053|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis on the change from baseline to week 58||||0.053
70985800|NCT03504774|141481233|OTHER||Mean Difference (Net)|0.3||||0.062|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change from week 52 to week 58||||0.062
70985801|NCT03504774|141481233|OTHER||Mean Difference (Net)|0.2||||0.3|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change from baseline to week 52||||0.30
70985802|NCT03504774|141481233|OTHER||Mean Difference (Net)|1.0||||0.54|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change from baseline to week 58||||0.54
70985803|NCT03504774|141481233|OTHER||Mean Difference (Net)|1.2||||0.82|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change from week 52 to week 58||||0.82
70985804|NCT03504774|141481234|OTHER||Mean Difference (Net)|4.8||||0.25|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in INFG from baseline to week 52||||0.25
70985805|NCT03504774|141481234|OTHER||Mean Difference (Net)|10.8||||0.24|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in INFG from baseline to week 58||||0.24
70985806|NCT03504774|141481234|OTHER||Mean Difference (Net)|6.0||||0.61|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in INFG from week 52 to week 58||||0.61
70985807|NCT03504774|141481234|OTHER||Mean Difference (Net)|8.5||||0.034|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in INFG from baseline to week 52||||0.034
70985808|NCT03504774|141481234|OTHER||Mean Difference (Net)|0.8||||0.45|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in INFG from baseline to week 58||||0.45
70985809|NCT03504774|141481234|OTHER||Mean Difference (Net)|7.7||||0.12|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in INFG from week 52 to week 58||||0.12
70985810|NCT03504774|141481234|OTHER||Mean Difference (Net)|1.0||||0.83|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL4 from baseline to week 52||||0.83
70985811|NCT03504774|141481234|OTHER||Mean Difference (Net)|2.0||||0.67|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL4 from baseline to week 58||||0.67
70985812|NCT03504774|141481234|OTHER||Mean Difference (Net)|1.0||||0.8|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL4 from week 52 to week 58||||0.80
70985813|NCT03504774|141481234|OTHER||Mean Difference (Net)|1.7||||0.46|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL4 from baseline to week 52||||0.46
70985814|NCT03504774|141481234|OTHER||Mean Difference (Net)|3.2||||0.48|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL4 from baseline to week 58||||0.48
70985815|NCT03504774|141481234|OTHER||Mean Difference (Net)|3.2||||0.25|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL4 from week 52 to week 58||||0.25
70985816|NCT03504774|141481234|OTHER||Mean Difference (Net)|2.6||||0.14|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL10 from baseline to week 52||||0.14
71037751|NCT00112437|141582563|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.06|||<=|0.001|TWO_SIDED|95.0|1.2|2.93||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 12 months.||2.93|1.20|<=0.001
71037752|NCT00112437|141582563|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.67|||<=|0.001|TWO_SIDED|95.0|0.8|2.53||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 12 months.||2.53|0.80|<=0.001
71037753|NCT00112437|141582563|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.75||||0.135|TWO_SIDED|95.0|-1.61|0.11||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 12 months.||0.11|-1.61|0.135
71097930|NCT01260324|141704193|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.07|||||TWO_SIDED|95.0|0.05|0.08|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Acute sinusitis||0.08|0.05|
71097931|NCT01260324|141704193|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.06|||||TWO_SIDED|95.0|0.05|0.08|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Other dermatoses||0.08|0.05|
71097932|NCT01260324|141704193|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.08|||||TWO_SIDED|95.0|0.06|0.1|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Other disorders of bone and cartilage||0.10|0.06|
71097933|NCT01260324|141704193|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.12|||||TWO_SIDED|95.0|0.1|0.14|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Symptoms involving head and neck||0.14|0.10|
70985817|NCT03504774|141481234|OTHER||Mean Difference (Net)|0.6||||0.73|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL10 from baseline to week 58||||0.73
70985818|NCT03504774|141481234|OTHER||Mean Difference (Net)|2.0||||0.16|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL10 from week 52 to week 58||||0.16
70985819|NCT03504774|141481234|OTHER||Mean Difference (Net)|1.8||||0.47|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL10 from baseline to week 52||||0.47
70985820|NCT03504774|141481234|OTHER||Mean Difference (Net)|1.1||||0.84|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL10 from baseline to week 58||||0.84
70985821|NCT03504774|141481234|OTHER||Mean Difference (Net)|0.7||||0.55|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL10 from week 52 to week 58||||0.55
70985822|NCT03504774|141481235|OTHER||Mean Difference (Net)|2269.0||||0.23|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in GPR15 from baseline to week 52||||0.23
70985823|NCT03504774|141481235|OTHER||Mean Difference (Net)|1311.0||||0.12|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in GPR15 from baseline to week 58||||0.12
70985824|NCT03504774|141481235|OTHER||Mean Difference (Net)|958.0||||0.79|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in GPR15 from week 52 to week 58||||0.79
70985825|NCT03504774|141481235|OTHER||Mean Difference (Net)|347.0||||0.29|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in GPR15 from baseline to week 52||||0.29
70985826|NCT03504774|141481235|OTHER||Mean Difference (Net)|4364.0||||0.29|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in GPR15 from baseline to week 58||||0.29
70985827|NCT03504774|141481235|OTHER||Mean Difference (Net)|4017.0||||0.42|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in GPR15 from week 52 to week 58||||0.42
70985828|NCT00719576|141481256|SUPERIORITY|The Wilks lambda test statistic and associated single P value from the MANOVA model were used to test the statistical significance of the difference in the co-primary endpoint between MACI and microfracture.||||||0.001|||||||MANOVA|||The changes from Baseline to Week 104 in KOOS Pain and Function (SRA) scores (co-primary efficacy parameter) were analyzed with a multivariate analysis of variance (MANOVA) model, with the last observation carried forward (LOCF) method for handling missing data. Terms included in the model are treatment and center as class variables and baseline KOOS pain and Function (SRA) as continuous covariates.||||0.001
70985829|NCT00719576|141481257|SUPERIORITY_OR_OTHER_LEGACY|||||||0.717||||||Differences between groups were tested using analysis of variance|ANOVA|ANOVA with terms for treatment and center||||||.717
71097934|NCT01260324|141704193|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.14|||||TWO_SIDED|95.0|0.1|0.18|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Other ill defined and unknown causes of morbidity and mortality||0.18|0.10|
70985830|NCT00719576|141481258|SUPERIORITY|||||||0.92|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Row Mean Score Chi-Square||Differences between groups were tested by the Cochran-Mantel-Haenszel row mean score chi-squared test for defect fill.||||.920
70985831|NCT00719576|141481259|SUPERIORITY|||||||0.016||||||KOOS Response Rate: a participant is regarded as a responder for KOOS if a 10-point improvement in both KOOS Pain and Function (SRA) scores was achieved with respect to Baseline. Otherwise, the patient is regarded as a nonresponder.|Cochran-Mantel-Haenszel|p-value was calculated for response categories 'Responded' and 'Not responded' using a Cochran-Mantel-Haenszel χ2 Test stratified by Center||Differences between groups were tested by the Cochran-Mantel-Haenszel chi-squared test stratified by center for responders.||||0.016
70985832|NCT00719576|141481261|SUPERIORITY||||||<|0.001||||||KOOS activities of daily living p-value \<0.001|ANCOVA|||Analysis of covariance was conducted with treatment and center as fixed effects and Baseline subscale as covariate, conducted at α = 0.05 level of significance. Last observation carried forward was used for missing data imputation.||||<0.001
70985833|NCT00719576|141481261|SUPERIORITY|||||||0.029||||||KOOS knee-related quality of life p-value 0.029|ANCOVA|||Analysis of covariance was conducted with treatment and center as fixed effects and Baseline subscale as covariate, conducted at α = 0.05 level of significance. Last observation carried forward was used for missing data imputation.||||0.029
70985834|NCT00719576|141481261|SUPERIORITY||||||<|0.001||||||KOOS other symptoms p-value \<0.001|ANCOVA|||Analysis of covariance was conducted with treatment and center as fixed effects and Baseline subscale as covariate, conducted at α = 0.05 level of significance. Last observation carried forward was used for missing data imputation.||||<0.001
71097935|NCT01260324|141704193|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.65|||||TWO_SIDED|95.0|4.72|9.38|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Other retinal disorders||9.38|4.72|
71097936|NCT01260324|141704193|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.6|||||TWO_SIDED|95.0|1.77|3.81|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Glaucoma||3.81|1.77|
71097937|NCT01260324|141704193|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.31|||||TWO_SIDED|95.0|1.02|1.68|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Cataract||1.68|1.02|
71097938|NCT01260324|141704193|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|14.2|||||TWO_SIDED|95.0|10.4|19.3|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Visual disturbances||19.30|10.40|
71097939|NCT01260324|141704193|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|15.1|||||TWO_SIDED|95.0|6.6|34.5|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Blindness and low vision||34.50|6.60|
71097940|NCT01260324|141704193|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.02|||||TWO_SIDED|95.0|1.44|2.82|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Other disorders of eye||2.82|1.44|
70985835|NCT00305006|141481270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|1.0|<|0.01|TWO_SIDED|95.0||||ANOVA|ANOVA|||ANOVA||||<0.01
70985836|NCT00631488|141481272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.9||||0.002|TWO_SIDED|95.0|5.2|22.7|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+sitagliptin provide greater reduction in 24-hour WMG than sitagliptin+metformin. Using a standard deviation (SD) of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 24-hour WMG between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval (CI) for the between group difference.||22.7|5.2|0.002
70985837|NCT00631488|141481272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.8|||<|0.001|TWO_SIDED|95.0|-26.5|-9.2|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+metformin provide greater reduction in 24-hour WMG than sitagliptin+metformin. Using a standard deviation (SD) of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 24-hour WMG between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval for the between group difference.||-9.2|-26.5|<0.001
70985838|NCT00631488|141481273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.1||||0.05|TWO_SIDED|95.0|0.0|18.2|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+sitagliptin provide greater reduction in 24-hour FPG than sitagliptin+metformin. Using a standard deviation (SD) of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 24-hour FPG between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval for the between group difference.||18.2|0.0|0.050
71097941|NCT01260324|141704193|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.64|2.31|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Occlusion and stenosis of precerebral arteries||2.31|0.64|
71097942|NCT01260324|141704193|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.29|||||TWO_SIDED|95.0|0.96|1.74|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Acute sinusitis||1.74|0.96|
71097943|NCT01260324|141704193|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|1.02|1.77|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Other dermatoses||1.77|1.02|
71097944|NCT01260324|141704193|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.98|1.77|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Other disorders of bone and cartilage||1.77|0.98|
71097945|NCT01260324|141704193|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37|||||TWO_SIDED|95.0|1.02|1.84|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Symptoms involving head and neck||1.84|1.02|
71097946|NCT01260324|141704193|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.64|||||TWO_SIDED|95.0|1.08|2.49|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Ill defined and unknown causes of morbidity and mortality||2.49|1.08|
70985839|NCT00631488|141481273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.1|||<|0.001|TWO_SIDED|95.0|-28.0|-10.1|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+metformin provide greater reduction in 24-hour FPG than sitagliptin+metformin. Using a standard deviation (SD) of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 24-hour FPG between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval for the between group difference.||-10.1|-28.0|<0.001
70985840|NCT00631488|141481274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.6||||0.056|TWO_SIDED|95.0|-0.6|45.8|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+sitagliptin provide greater reduction in 2-hr Glucose AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Glucose Total AUC between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval for the between group difference.||45.8|-0.6|0.056
70985841|NCT00631488|141481274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.6|||<|0.001|TWO_SIDED|95.0|-67.3|-21.8|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+metformin provide greater reduction in 2-hr Glucose AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Glucose Total AUC between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval for the between group difference.||-21.8|-67.3|<0.001
70985842|NCT00631488|141481275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2||||0.001|TWO_SIDED|95.0|1.7|6.7|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+sitagliptin provide greater reduction in 2-Hour Total GLP-1 Total AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants/group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Total GLP-1 Total AUC between any 2 treatment groups for a 2-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% CI for the between group difference.||6.7|1.7|0.001
70985843|NCT00631488|141481275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.2|||<|0.001|TWO_SIDED|95.0|10.7|15.7|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+metformin provide greater reduction in 2-Hour Total GLP-1 Total AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants/group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Total GLP-1 Total AUC between any 2 treatment groups for a 2-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% CI for the between group difference.||15.7|10.7|<0.001
70985844|NCT00631488|141481276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||<|0.001|TWO_SIDED|95.0|-9.5|-3.8|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+sitagliptin provide greater reduction in 2-Hour Active GLP-1 Total AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants/group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Active GLP-1 Total AUC between any 2 treatment groups for a 2-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% CI for the between group difference||-3.8|-9.5|<0.001
70985845|NCT00631488|141481276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.3|||<|0.001|TWO_SIDED|95.0|-14.1|-8.5|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+metformin provide greater reduction in 2-Hour Active GLP-1 Total AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants/group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Active GLP-1 Total AUC between any 2 treatment groups for a 2-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% CI for the between group difference.||-8.5|-14.1|<0.001
70985846|NCT02546856|141481289|NON_INFERIORITY|For the hypothesis that the relative dose of BBs would reach 52% by the end of the study and using an equivalence margin of 7%, we would need 157 patients per group for an alpha level of significance of 0.05 and a statistical power of 80% (beta of 0.80).|Mean Difference (Final Values)|14.8|||<|0.001|TWO_SIDED|95.0|7.5|22.1|||t-test, 2 sided|||||22.1|7.5|<0.001
70985847|NCT02546856|141481290|EQUIVALENCE|equivalence margin of 5%|Difference in percentages|1.4||||0.52|TWO_SIDED|95.0|-3.33|6.32|||Chi-squared|||||6.32|-3.33|0.52
70985848|NCT02546856|141481291|NON_INFERIORITY|Equivalence margin of 5%|Difference in percentages|2.1||||0.31|TWO_SIDED|95.0|-1.9|6.1|||Chi-squared|||||6.1|-1.9|0.31
70985849|NCT02546856|141481292|NON_INFERIORITY|Equivalence margin of 5%|Difference in percentages|-0.63||||0.85|TWO_SIDED|95.0|-7.1|5.85|||Chi-squared|||||5.85|-7.1|0.85
70985850|NCT02546856|141481293|NON_INFERIORITY|Equivalence margin of 5%|Difference in percentages|2.12||||0.44|TWO_SIDED|95.0|-3.3|7.54|||Chi-squared|||||7.54|-3.3|0.44
70985851|NCT02546856|141481295|NON_INFERIORITY|equivalence margin of 5%|Difference in percentages|0.7||||0.56|TWO_SIDED|95.0|-1.6|3.04|||Chi-squared|||||3.04|-1.6|0.56
70985852|NCT02546856|141481299|NON_INFERIORITY|Equivalence margin of 5%|Mean Difference (Final Values)|0.07||||0.96|TWO_SIDED|95.0|-2.69|2.83|||t-test, 2 sided|||||2.83|-2.69|0.96
70985853|NCT02546856|141481300|NON_INFERIORITY|Equivalence margin of 5%|Mean Difference (Final Values)|16.47||||0.97|TWO_SIDED|95.0|-781.0|748.0|||t-test, 2 sided|||||748|-781|0.97
70985854|NCT02546856|141481301|NON_INFERIORITY|Equivalence margin of 5%|Mean Difference (Final Values)|7.28||||0.44|TWO_SIDED|95.0|-11.27|25.83|||t-test, 2 sided|||||25.83|-11.27|0.44
71097947|NCT01260324|141704194|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.03|0.07|||||Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.|Incidence rate Recent use||0.07|0.03|
70985855|NCT02546856|141481303|NON_INFERIORITY|Equivalence margin of 5%|Mean Difference (Final Values)|-0.91||||0.75|TWO_SIDED|95.0|-6.63|4.81|||t-test, 2 sided|||||4.81|-6.63|0.75
70985856|NCT02546856|141481304|NON_INFERIORITY|Equivalence margin of 5%|Mean Difference (Final Values)|0.04||||0.2|TWO_SIDED|95.0|-0.2|0.28|||t-test, 2 sided|||||0.28|-0.2|0.20
70985857|NCT02546856|141481305|EQUIVALENCE|equivalence margin of 5%|Difference in percentages|-5.5||||0.01|TWO_SIDED|95.0|-9.7|-1.4|||Chi-squared|||||-1.4|-9.7|0.01
70985858|NCT02546856|141481306|NON_INFERIORITY|Equivalence margin of 5%|Difference in percentages|-0.68||||0.71|TWO_SIDED|95.0|-4.2|2.87|||Chi-squared|Equivalence margin of 7%||||2.87|-4.2|0.71
70985859|NCT02546856|141481307|NON_INFERIORITY|Equivalence margin of 7%|Mean Difference (Final Values)|16.5|||<|0.001|TWO_SIDED|95.0|8.7|24.3|||t-test, 2 sided|||||24.3|8.7|<0.001
70985860|NCT02546856|141481308|NON_INFERIORITY|Equivalence margin of 7%|Mean Difference (Final Values)|0.9||||0.93|TWO_SIDED|95.0|-15.1|17.1|||t-test, 2 sided|||||17.1|-15.1|0.93
70985861|NCT02546856|141481309|NON_INFERIORITY|Equivalence margin of 7%|Mean Difference (Final Values)|0.5||||0.86|TWO_SIDED|95.0|-7.1|8.2|||t-test, 2 sided|||||8.2|-7.1|0.86
70985862|NCT01097616|141481310|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|19.6|||<|1e-05|TWO_SIDED|95.0|12.0|27.1||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 sTSTm, had planned marginal power of 97.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||27.1|12.0|<0.00001
70985863|NCT01097616|141481311|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|19.7|||<|1e-05|TWO_SIDED|95.0|11.9|27.6||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 sTSTm, had planned marginal power of 95.7%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||27.6|11.9|<0.00001
70985864|NCT01097616|141481312|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-26.3|||<|1e-05|TWO_SIDED|95.0|-33.5|-19.2||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 WASO, had planned marginal power of 99.2%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-19.2|-33.5|<0.00001
70985865|NCT01097616|141481313|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-22.9|||<|1e-05|TWO_SIDED|95.0|-30.3|-15.4||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 WASO, had planned marginal power of 98.3%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-15.4|-30.3|<0.00001
71037754|NCT00112437|141582564|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.66|||<=|0.001|TWO_SIDED|95.0|1.71|3.61||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 12 months.||3.61|1.71|<=0.001
71037755|NCT00112437|141582564|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.89|||<=|0.001|TWO_SIDED|95.0|0.93|2.84||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 12 months.||2.84|0.93|<=0.001
71037756|NCT00112437|141582564|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.87||||0.095|TWO_SIDED|95.0|-0.09|1.82||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 12 months.||1.82|-0.09|0.095
71097948|NCT01260324|141704194|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.06|||||TWO_SIDED|95.0|0.04|0.08|||||Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.|Incidence rate Any use (includes chronic and non-chronic use)||0.08|0.04|
71097949|NCT01260324|141704194|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.03|0.08|||||Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.|Incidence rate Chronic use||0.08|0.03|
70985866|NCT01097616|141481314|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-7.4||||0.00298|TWO_SIDED|95.0|-12.3|-2.5||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 sTSOm, had planned marginal power of 99.9%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-2.5|-12.3|0.00298
70985867|NCT01097616|141481315|SUPERIORITY_OR_OTHER||[Difference in Least Squares Means|-8.4||||0.00019|TWO_SIDED|95.0|-12.8|-4.0||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 sTSOm, had planned marginal power of 99.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-4.0|-12.8|0.00019
70985868|NCT01097616|141481316|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-11.2||||2e-05|TWO_SIDED|95.0|-16.3|-6.1||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 LPS, had planned marginal power of 81.4%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-6.1|-16.3|0.00002
70985869|NCT01097616|141481317|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-9.4||||0.00037|TWO_SIDED|95.0|-14.6|-4.3||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 LPS, had planned marginal power of 76.2%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-4.3|-14.6|0.00037
70985870|NCT01097616|141481318|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|13.6||||7e-05|TWO_SIDED|95.0|6.9|20.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance and sleep onset endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either the subjective or objective Month 3 endpoint must be significant to test the Week 1/Night 1 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||20.3|6.9|0.00007
70985871|NCT01097616|141481318|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|21.4|||<|1e-05|TWO_SIDED|95.0|15.5|27.4|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Week 1 sTSTm, had planned marginal power of 98.3%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||27.4|15.5|<0.00001
71008799|NCT02055976|141525256|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-33.30375|STANDARD_ERROR_OF_MEAN|3.07498|<|0.001|TWO_SIDED|95.0|-39.41376|-27.19373|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-27.19373|-39.41376|<0.001
71097950|NCT01260324|141704194|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.06|||||TWO_SIDED|95.0|0.03|0.11|||||Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.|Incidence rate Non-chronic use||0.11|0.03|
71097951|NCT01260324|141704194|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.09|||||TWO_SIDED|95.0|0.08|0.1|||||Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.|Incidence rate Never use||0.10|0.08|
71097952|NCT00004228|141704198|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Regression, Cox|||"A Cox model was used to assess evidence of a difference in event-free survival comparing regimens A1+A2 (A: CCG BFM) to regimens B1+B2 (B: NHL/BFM-95) while adjusting for the other intervention through stratification."||||.97
71037757|NCT00112437|141582564|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.19|||||TWO_SIDED|95.0|-1.14|0.75|||ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 12 months.||0.75|-1.14|
71037758|NCT00112437|141582565|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.94|||<=|0.001|TWO_SIDED|95.0|1.64|4.24||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 12 months.||4.24|1.64|<=0.001
71097953|NCT00004228|141704198|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED||||||Regression, Cox|||"A Cox model was used to assess evidence of a difference in event-free survival comparing A1+B1 (1: no intensification) to A2 +B2 (2: intensification), while adjusting for the other intervention through stratification."||||.63
71097954|NCT01292473|141704206|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.69||||0.4637|TWO_SIDED|95.0|-2.54|1.16||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||1.16|-2.54|0.4637
71097955|NCT01292473|141704206|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.04||||0.0011|TWO_SIDED|95.0|-4.85|-1.24||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||-1.24|-4.85|0.0011
71097956|NCT01292473|141704206|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.81|||<|0.0001|TWO_SIDED|95.0|-6.49|-3.13||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg groups.||-3.13|-6.49|<0.0001
71097957|NCT01292473|141704207|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.73||||0.1575|TWO_SIDED|95.0|-6.53|1.07||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||1.07|-6.53|0.1575
71097958|NCT01292473|141704207|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.69||||0.0001||95.0|-11.49|-3.88||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||-3.88|-11.49|0.0001
71097959|NCT01292473|141704207|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-12.4|||<|0.0001|TWO_SIDED|95.0|-16.13|-8.66||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg groups.||-8.66|-16.13|<0.0001
70985872|NCT01097616|141481319|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|16.3||||0.00016|TWO_SIDED|95.0|7.9|24.8|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||24.8|7.9|0.00016
71097960|NCT01292473|141704208|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.01||||0.0603|TWO_SIDED|95.0|-4.11|0.09||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||0.09|-4.11|0.0603
70985873|NCT01097616|141481320|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|10.7||||0.01711|TWO_SIDED|95.0|1.9|19.5|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||19.5|1.9|0.01711
70985874|NCT01097616|141481321|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-32.5|||<|1e-05|TWO_SIDED|95.0|-39.3|-25.7|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance and sleep onset endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either the subjective or objective Month 3 endpoint must be significant to test the Week 1/Night 1 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-25.7|-39.3|<0.00001
70985875|NCT01097616|141481321|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-38.4|||<|1e-05|TWO_SIDED|95.0|-44.5|-32.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Night 1 WASO, had planned marginal power of 100.0%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||-32.3|-44.5|<0.00001
70985876|NCT01097616|141481322|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-26.4|||<|1e-05|TWO_SIDED|95.0|-34.3|-18.4|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-18.4|-34.3|<0.00001
70985877|NCT01097616|141481323|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-16.6||||9e-05|TWO_SIDED|95.0|-24.8|-8.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-8.3|-24.8|0.00009
70985878|NCT01097616|141481324|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-5.6||||0.01564|TWO_SIDED|95.0|-10.2|-1.1|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance and sleep onset endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either the subjective or objective Month 3 endpoint must be significant to test the Week 1/Night 1 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-1.1|-10.2|0.01564
70985879|NCT01097616|141481324|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-5.7||||0.00609|TWO_SIDED|95.0|-9.7|-1.6|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Week 1 sTSOm, had planned marginal power of 99.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||-1.6|-9.7|0.00609
70985880|NCT01097616|141481325|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-5.4||||0.05191|TWO_SIDED|95.0|-10.9|0.0|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||0.0|-10.9|0.05191
70985881|NCT01097616|141481326|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-5.2||||0.03771|TWO_SIDED|95.0|-10.2|-0.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-0.3|-10.2|0.03771
71097961|NCT01292473|141704208|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.51|||<|0.0001|TWO_SIDED|95.0|-6.65|-2.36||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||-2.36|-6.65|<0.0001
71097962|NCT01292473|141704208|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.09|||<|0.0001|TWO_SIDED|95.0|-9.26|-4.93||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg groups.||-4.93|-9.26|<0.0001
70985882|NCT01097616|141481329|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-9.6||||0.00041|TWO_SIDED|95.0|-14.9|-4.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance and sleep onset endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either the subjective or objective Month 3 endpoint must be significant to test the Week 1/Night 1 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-4.3|-14.9|0.00041
70985883|NCT01097616|141481329|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-10.3||||2e-05|TWO_SIDED|95.0|-15.0|-5.5|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Night 1 LPS, had planned marginal power of 100.0%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||-5.5|-15.0|0.00002
70985884|NCT01097616|141481330|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-10.3||||0.0004|TWO_SIDED|95.0|-16.0|-4.6|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-4.6|-16.0|0.00040
70985885|NCT01097616|141481331|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-8.1||||0.00606|TWO_SIDED|95.0|-13.8|-2.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-2.3|-13.8|0.00606
70985886|NCT03626415|141481335|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Mean|94.4|||||TWO_SIDED|90.0|62.96|141.55|||ANOVA|||Mild Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||141.55|62.96|
70985887|NCT03626415|141481335|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adusted Geometric Means|105.53|||||TWO_SIDED|90.0|70.38|158.24|||ANOVA|||Moderate Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||158.24|70.38|
70985888|NCT03626415|141481336|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Means|133.33|||||TWO_SIDED|90.0|86.17|206.28|||ANOVA|||Mild Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||206.28|86.17|
70985889|NCT03626415|141481336|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Mean|153.99|||||TWO_SIDED|90.0|99.52|238.25|||ANOVA|||Moderate Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||238.25|99.52|
71097963|NCT01292473|141704209|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.43||||0.0478|TWO_SIDED|95.0|1.0|2.05||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between Placebo and Omalizumab 75 mg.||2.05|1.00|0.0478
70985890|NCT03626415|141481337|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Means|75.94|||||TWO_SIDED|90.0|57.39|100.47|||ANOVA|||Mild Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||100.47|57.39|
70985891|NCT03626415|141481337|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Means|84.14|||||TWO_SIDED|90.0|63.59|111.33|||ANOVA|||Moderate Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||111.33|63.59|
70985892|NCT03626415|141481338|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Means|95.74|||||TWO_SIDED|90.0|72.71|126.08|||ANOVA|||Mild Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||126.08|72.71|
70985893|NCT03626415|141481338|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Means|114.82|||||TWO_SIDED|90.0|87.19|151.2|||ANOVA|||Moderate Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||151.20|87.19|
70985894|NCT01703819|141481343|SUPERIORITY_OR_OTHER|||||||0.7726||||||Threshold less than or equal to 0.05. The final analysis demonstrated reasonable doubt of the implicit normality assumption of the two sets of AUC data, thus medians presented for efficacy analysis. Need for further investigation (ex-post analyses).|ANCOVA|||The null-hypotheses of no treatment differences were tested by the two-sided t-tests from the respective ANCOVAs.||||0.7726
70985895|NCT01703819|141481344|SUPERIORITY_OR_OTHER|||||||0.5702||||||Threshold less than or equal to 0.05. The final analysis demonstrated reasonable doubt of the implicit normality assumption of the two sets of AUC data, thus medians presented for efficacy analysis. Need for further investigation (ex-post analyses).|ANCOVA|||The null-hypotheses of no treatment differences were tested by the two-sided t-tests from the respective ANCOV As.||||0.5702
70985896|NCT00859898|141481356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.1056|<|0.0001|TWO_SIDED|95.0|-0.74|-0.32||Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant. Two-sided significance level at α=0.05|ANCOVA|treatment group as an effect and the baseline HbA1c value as a covariate.||||-0.32|-0.74|<0.0001
70985897|NCT00859898|141481356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.1072|<|0.0001|TWO_SIDED|95.0|-0.75|-0.33||Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant. Two-sided significance level at α=0.05|ANCOVA|treatment group as an effect and the baseline HbA1c value as a covariate.||||-0.33|-0.75|<0.0001
70985898|NCT00859898|141481356|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority of dapagliflozin 10 mg versus metformin XR was demonstrated when the upper limit of the two-sided 95% confidence interval of the difference in change in HbA1c from baseline to Week 24 (LOCF) between dapagliflozin 10 mg and metformin XR was less than 0.35%.|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.1054|||TWO_SIDED|95.0|-0.22|0.2|||ANCOVA|treatment group as an effect and the baseline value as a covariate||||0.20|-0.22|
70985899|NCT00859898|141481356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.1054||0.9144|TWO_SIDED|95.0|-0.22|0.2||two-sided significance level at α=0.05|ANCOVA|treatment group as an effect and the baseline HbA1c value as a covariate.||When testing for superiority, significance is claimed only if dapagliflozin 10 mg is superior to metformin XR||0.20|-0.22|0.9144
70985900|NCT00859898|141481357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.9|STANDARD_ERROR_OF_MEAN|3.558|<|0.0001|TWO_SIDED|95.0|-20.9|-7.0||two-sided significance level at α=0.05. Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|ANCOVA|treatment group as an effect and the baseline value as a covariate.||A hierarchical closed testing procedure was implemented to control the familywise type I error rate related to this endpoint at the two-sided 0.05 level. Statistical tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.||-7.0|-20.9|<0.0001
70985901|NCT00859898|141481357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.5|STANDARD_ERROR_OF_MEAN|3.59|<|0.0001|TWO_SIDED|95.0|-32.6|-18.5||two-sided significance level at α=0.05. Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|ANCOVA|treatment group as an effect and the baseline value as a covariate.||A hierarchical closed testing procedure was implemented to control the familywise type I error rate related to this endpoint at the two-sided 0.05 level. Statistical tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.||-18.5|-32.6|<0.0001
71097964|NCT01292473|141704209|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.59||||0.0101|TWO_SIDED|95.0|1.12|2.26||Refer to the Type-I error control plan.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||2.26|1.12|0.0101
70985902|NCT00859898|141481357|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority of dapagliflozin 10 mg versus metformin XR was demonstrated when the upper limit of the two-sided 95% confidence interval of the difference in change FPG from baseline to Week 24 (LOCF) between dapagliflozin 10 mg and metformin XR was less than 15 mg/dL.|Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|3.566|||TWO_SIDED|95.0|-18.6|-4.6|||ANCOVA|treatment group as an effect and the baseline value as a covariate||||-4.6|-18.6|
70985903|NCT00859898|141481357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|3.566||0.0012|TWO_SIDED|95.0|-18.6|-4.6||two-sided significance level at α=0.05.|ANCOVA|treatment group as an effect and the baseline value as a covariate.||When testing for superiority, significance is claimed only if dapagliflozin 10 mg is superior to metformin XR||-4.6|-18.6|0.0012
70985904|NCT00859898|141481358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.9|STANDARD_ERROR_OF_MEAN|4.598||0.0012|TWO_SIDED|95.0|5.9|23.9||Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|Regression, Logistic|Logistic regression based on the methodology of Zhang, Tsiatis and Davidian and Tsiatis, Davidian, Zhang and Lu, with adjustment for baseline HbA1c.||The probability of response was modeled using a logistic regression model with baseline HbA1c as the covariate. Treatment group estimates of response rate were then obtained by integrating each group's modeled probability of response over the observed distribution of baseline covariate (combined across groups).||23.9|5.9|0.0012
70985905|NCT00859898|141481358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.3|STANDARD_ERROR_OF_MEAN|4.73||0.0165|TWO_SIDED|95.0|2.1|20.6||Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|Regression, Logistic|Logistic regression based on the methodology of Zhang, Tsiatis and Davidian and Tsiatis, Davidian, Zhang and Lu, with adjustment for baseline HbA1c.||The probability of response was modeled using a logistic regression model with baseline HbA1c as the covariate. Treatment group estimates of response rate were then obtained by integrating each group's modeled probability of response over the observed distribution of baseline covariate (combined across groups).||20.6|2.1|0.0165
70985906|NCT00859898|141481359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.1807||0.0133|TWO_SIDED|95.0|-0.81|-0.09||two-sided significance level at α=0.05. Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|ANCOVA|: treatment group as an effect and the baseline HbA1c value as a covariate.||A hierarchical closed testing procedure was implemented to control the familywise type I error rate related to this endpoint at the two-sided 0.05 level. Statistical testing was only performed if the dapagliflozin 10 mg plus metformin XR group was statistically significantly superior to both control groups for the primary efficacy endpoint. Tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.||-0.09|-0.81|0.0133
70985907|NCT00859898|141481359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.1817||0.0036|TWO_SIDED|95.0|-0.89|-0.18||two-sided significance level at α=0.05. Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|ANCOVA|treatment group as an effect and the baseline HbA1c value as a covariate.||A hierarchical closed testing procedure was implemented to control the familywise type I error rate related to this endpoint at the two-sided 0.05 level. Statistical testing was only performed if the dapagliflozin 10 mg plus metformin XR group was statistically significantly superior to both control groups for the primary efficacy endpoint. Tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.||-0.18|-0.89|0.0036
70985908|NCT00859898|141481360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.97|STANDARD_ERROR_OF_MEAN|0.3401|<|0.0001|TWO_SIDED|95.0|-2.64|-1.3||two-sided significance level at α=0.05|ANCOVA|treatment group as an effect and the baseline value as a covariate.||A hierarchical closed testing procedure was implemented to control the familywise type I error rate related to this endpoint at the two-sided 0.05 level. Statistical testing was only performed if the dapagliflozin 10 mg plus metformin XR group was statistically significantly superior to both control groups for the primary efficacy endpoint. Tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.||-1.30|-2.64|<0.0001
70985909|NCT00859898|141481360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|0.3362|<|0.0001|TWO_SIDED|95.0|-2.03|-0.71||two-sided significance level at α=0.05|ANCOVA|treatment group as an effect and the baseline value as a covariate||Statistical tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.||-0.71|-2.03|<0.0001
70985910|NCT02145156|141481368|SUPERIORITY_OR_OTHER|||||||0.36|||||||Fisher Exact|||||||.36
70985911|NCT02145156|141481368|SUPERIORITY_OR_OTHER|||||||0.18|||||||Fisher Exact|||||||.18
70985912|NCT02145156|141481368|SUPERIORITY_OR_OTHER|||||||0.22|||||||Fisher Exact|||||||.22
70985913|NCT02145156|141481368|SUPERIORITY_OR_OTHER|||||||0.88|||||||Fisher Exact|||||||.88
70985914|NCT02145156|141481369|SUPERIORITY_OR_OTHER|||||||0.35|||||||Fisher Exact|||||||0.35
70985915|NCT02145156|141481369|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
70985916|NCT02145156|141481369|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||||||.23
70985917|NCT02145156|141481369|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||||||.23
70985918|NCT02145156|141481370|SUPERIORITY_OR_OTHER|||||||0.37|||||||Fisher Exact|||||||0.37
70985919|NCT02145156|141481370|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||||||.23
70985920|NCT02145156|141481370|SUPERIORITY_OR_OTHER|||||||0.25|||||||Fisher Exact|||||||.25
70985921|NCT02145156|141481370|SUPERIORITY_OR_OTHER|||||||0.7|||||||Fisher Exact|||||||.70
70985922|NCT02145156|141481371|SUPERIORITY_OR_OTHER|||||||0.59|||||||Fisher Exact|||||||0.59
70985923|NCT02145156|141481371|SUPERIORITY_OR_OTHER|||||||0.52|||||||Fisher Exact|||||||.52
70985924|NCT02145156|141481371|SUPERIORITY_OR_OTHER|||||||0.71|||||||Fisher Exact|||||||.71
70985925|NCT02145156|141481371|SUPERIORITY_OR_OTHER|||||||0.34|||||||Fisher Exact|||||||.34
70985926|NCT02145156|141481372|SUPERIORITY_OR_OTHER|||||||0.16|||||||Fisher Exact|||||||0.16
70985927|NCT02145156|141481372|SUPERIORITY_OR_OTHER|||||||0.15|||||||Fisher Exact|||||||.15
70985928|NCT02145156|141481372|SUPERIORITY_OR_OTHER|||||||0.98|||||||Fisher Exact|||||||.98
70985929|NCT02145156|141481372|SUPERIORITY_OR_OTHER|||||||0.34|||||||Fisher Exact|||||||.34
70985930|NCT02145156|141481373|SUPERIORITY_OR_OTHER|||||||0.37|||||||Fisher Exact|||||||0.37
70985931|NCT02145156|141481373|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||||||.23
70985932|NCT02145156|141481373|SUPERIORITY_OR_OTHER|||||||0.25|||||||Fisher Exact|||||||.25
70985933|NCT02145156|141481373|SUPERIORITY_OR_OTHER|||||||0.7|||||||Fisher Exact|||||||.70
70985934|NCT02145156|141481374|SUPERIORITY_OR_OTHER|||||||0.87|||||||Chi-squared|||||||0.87
70985935|NCT02145156|141481374|SUPERIORITY_OR_OTHER|||||||0.62|||||||Chi-squared|||||||0.62
70985936|NCT02145156|141481374|SUPERIORITY_OR_OTHER|||||||0.81|||||||Chi-squared|||||||0.81
70985937|NCT02145156|141481374|SUPERIORITY_OR_OTHER|||||||0.76|||||||Chi-squared|||||||0.76
70985938|NCT02145156|141481375|SUPERIORITY_OR_OTHER|||||||0.7|||||||Chi-squared|||||||0.70
70985939|NCT02145156|141481375|SUPERIORITY_OR_OTHER|||||||0.41|||||||Chi-squared|||||||0.41
71037759|NCT00112437|141582565|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.65|||<=|0.001|TWO_SIDED|95.0|1.35|3.94||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 12 months.||3.94|1.35|<=0.001
71037760|NCT00112437|141582565|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.38|||<=|0.001|TWO_SIDED|95.0|1.08|3.69||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 12 months.||3.69|1.08|<=0.001
71037761|NCT00112437|141582565|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.29||||0.731|TWO_SIDED|95.0|-1.58|1.0||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 12 months.||1.00|-1.58|0.731
71037762|NCT00112437|141582566|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.29||||0.112|TWO_SIDED|95.0|-0.77|1.35||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total body BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total body BMD compared to placebo over 12 months.||1.35|-0.77|0.112
71097965|NCT01292473|141704209|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.12|||<|0.0001|TWO_SIDED|95.0|1.48|3.03||Refer to the Type-I error control plan.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between placebo and omalizumab 300 mg groups.||3.03|1.48|<0.0001
71097966|NCT01292473|141704210|SUPERIORITY_OR_OTHER|||||||0.3419||||||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||||0.3419
70985940|NCT02145156|141481375|SUPERIORITY_OR_OTHER|||||||0.59|||||||Chi-squared|||||||0.59
70985941|NCT02145156|141481375|SUPERIORITY_OR_OTHER|||||||0.74|||||||Chi-squared|||||||0.74
70985942|NCT02145156|141481376|SUPERIORITY_OR_OTHER|||||||0.38|||||||Chi-squared|||||||0.38
70985943|NCT02145156|141481376|SUPERIORITY_OR_OTHER|||||||0.17|||||||Chi-squared|||||||0.17
70985944|NCT02145156|141481376|SUPERIORITY_OR_OTHER|||||||0.6|||||||Chi-squared|||||||0.60
70985945|NCT02145156|141481376|SUPERIORITY_OR_OTHER|||||||0.35|||||||Chi-squared|||||||0.35
70985946|NCT02145156|141481377|SUPERIORITY_OR_OTHER|||||||0.39|||||||Chi-squared|||||||0.39
70985947|NCT02145156|141481377|SUPERIORITY_OR_OTHER|||||||0.51|||||||Chi-squared|||||||0.51
71097967|NCT01292473|141704210|SUPERIORITY_OR_OTHER|||||||0.001||||||Refer to the Type-I error control plan.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||||0.0010
71097968|NCT01292473|141704210|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Refer to the Type-I error control plan.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between placebo and omalizumab 300 mg groups.||||<0.0001
70985948|NCT02145156|141481377|SUPERIORITY_OR_OTHER|||||||0.49|||||||Chi-squared|||||||0.49
70985949|NCT02145156|141481377|SUPERIORITY_OR_OTHER|||||||0.14|||||||Chi-squared|||||||0.14
70985950|NCT02145156|141481378|SUPERIORITY_OR_OTHER|||||||0.09|||||||Chi-squared|||||||0.09
70985951|NCT02145156|141481378|SUPERIORITY_OR_OTHER|||||||0.51|||||||Chi-squared|||||||0.51
70985952|NCT02145156|141481378|SUPERIORITY_OR_OTHER|||||||0.15|||||||Chi-squared|||||||0.15
70985953|NCT02145156|141481378|SUPERIORITY_OR_OTHER|||||||0.03|||||||Chi-squared|||||||0.03
70985954|NCT02145156|141481379|SUPERIORITY_OR_OTHER|||||||0.38|||||||Chi-squared|||||||0.38
70985955|NCT02145156|141481379|SUPERIORITY_OR_OTHER|||||||0.17|||||||Chi-squared|||||||0.17
70985956|NCT02145156|141481379|SUPERIORITY_OR_OTHER|||||||0.6|||||||Chi-squared|||||||0.60
70985957|NCT02145156|141481379|SUPERIORITY_OR_OTHER|||||||0.35|||||||Chi-squared|||||||0.35
70985958|NCT05232097|141481470|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: the median of differences of the rumination score before and after therapy equals 0.||||0.005
70985959|NCT05232097|141481471|OTHER|||||||0.11|||||||Chi-squared|||The null hypothesis is that the same number of patients has intragastric pressure peaks indicating rumination before and after therapy.||||0.11
70985960|NCT05232097|141481472|OTHER|||||||0.06|||||||t-test, 2 sided|||Null hypothesis: The differences of means of 15D before and after therapy equals 0.||||0.060
70985961|NCT05232097|141481473|OTHER|||||||0.865|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: The median of differences of WHODAS 2.0 before and after therapy equals 0.||||0.865
70985962|NCT05232097|141481474|OTHER|||||||0.149|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis : the differences of median BDI before and after behavioral therapy equals 0.||||0.149
70985963|NCT05232097|141481475|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: The differences of median of BAI before and after behavioral therapy equals 0.||||1.000
71097969|NCT01292473|141704211|SUPERIORITY_OR_OTHER|||||||0.4366||||||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||||0.4366
71097970|NCT01292473|141704211|SUPERIORITY_OR_OTHER|||||||0.0045||||||Refer to the Type-I error control plan.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||||0.0045
71097971|NCT01292473|141704211|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Refer to the Type-I error control plan.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg groups.||||<0.0001
71097972|NCT01292473|141704212|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.48||||0.0082|TWO_SIDED|95.0|-4.32|-0.65||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||-0.65|-4.32|0.0082
71097973|NCT01292473|141704212|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.76|||<|0.0001|TWO_SIDED|95.0|-5.61|-1.9||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||-1.90|-5.61|<0.0001
71097974|NCT01292473|141704212|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.15|||<|0.0001|TWO_SIDED|95.0|-9.03|-5.27||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and the omalizumab 300 mg groups.||-5.27|-9.03|<0.0001
71097975|NCT01292473|141704213|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.68||||0.1207|TWO_SIDED|95.0|-3.82|0.45||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||0.45|-3.82|0.1207
70985964|NCT05232097|141481476|OTHER|||||||0.102|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: The differences of median weight before and after therapy equals 0.||||0.102
70985965|NCT01327339|141481477|SUPERIORITY_OR_OTHER||percentage of participants|5.9|||||TWO_SIDED|95.0|4.3|7.8|||||The estimated value represents the percentage of participants with an adverse event.|||7.8|4.3|
70985966|NCT01847547|141481483|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||||95.0|0.64|1.7|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||1.70|0.64|
70985967|NCT01847547|141481484|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||||95.0|0.69|1.36|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||1.36|0.69|
70985968|NCT01847547|141481485|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||||95.0|0.62|2.45|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||2.45|0.62|
71037763|NCT00112437|141582566|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.09|||||TWO_SIDED|95.0|-1.13|0.95||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total body BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total body BMD compared to placebo over 12 months.||0.95|-1.13|
71037764|NCT00112437|141582566|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.63|||||TWO_SIDED|95.0|-1.69|0.42||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total body BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total body BMD compared to placebo over 12 months.||0.42|-1.69|
71037765|NCT00112437|141582566|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.47|||||TWO_SIDED|95.0|-2.53|-0.42||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total body BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total body BMD compared to placebo over 12 months.||-0.42|-2.53|
71037766|NCT00112437|141582567|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.23|||<=|0.001|TWO_SIDED|95.0|0.22|2.24||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on distal forearm BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase distal forearm BMD compared to placebo over 12 months.||2.24|0.22|<=0.001
71037767|NCT00112437|141582567|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.1||||0.005|TWO_SIDED|95.0|0.09|2.11||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on distal forearm BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase distal forearm BMD compared to placebo over 12 months.||2.11|0.09|0.005
71037768|NCT00112437|141582567|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.27||||0.63|TWO_SIDED|95.0|-0.74|1.29||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on distal forearm BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase distal forearm BMD compared to placebo over 12 months.||1.29|-0.74|0.630
71097976|NCT01292473|141704213|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.51||||0.0215|TWO_SIDED|95.0|-4.64|-0.38||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||-0.38|-4.64|0.0215
71097977|NCT01292473|141704213|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.79||||0.0004|TWO_SIDED|95.0|-5.85|-1.73||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg groups.||-1.73|-5.85|0.0004
70985969|NCT01847547|141481486|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29||||||95.0|0.15|0.59|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||0.59|0.15|
70985970|NCT01847547|141481487|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||||95.0|0.15|0.67|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible.||0.67|0.15|
70985971|NCT01847547|141481488|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.27||||||95.0|0.09|0.84|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||0.84|0.09|
70985972|NCT01847547|141481489|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||||95.0|0.78|2.01|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||2.01|0.78|
70985973|NCT01847547|141481491|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||||95.0|0.48|1.14|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||1.14|0.48|
70985974|NCT01847547|141481492|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||||95.0|0.47|2.2|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||2.20|0.47|
70985975|NCT01847547|141481493|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||||95.0|0.21|1.98|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and very few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||1.98|0.21|
70985976|NCT01847547|141481494|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||||95.0|0.5|1.08|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||1.08|0.50|
70985977|NCT01847547|141481495|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||||95.0|0.21|0.76|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||0.76|0.21|
70985978|NCT01847547|141481496|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||||95.0|0.58|1.55|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||1.55|0.58|
70985979|NCT01847547|141481497|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.36||||||95.0|0.32|5.72|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and very few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||5.72|0.32|
71097978|NCT01292473|141704214|SUPERIORITY_OR_OTHER|||||||0.1361||||||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||||0.1361
71097979|NCT01292473|141704214|SUPERIORITY_OR_OTHER|||||||0.0905||||||Refer to the Type-I error control plan.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||||0.0905
70985980|NCT01847547|141481498|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||||95.0|0.83|3.08|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||3.08|0.83|
70985981|NCT01847547|141481499|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||||95.0|0.57|3.7|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||3.70|0.57|
70985982|NCT01847547|141481500|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||||95.0|0.67|1.35|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible.||1.35|0.67|
70985983|NCT01847547|141481501|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26||||||95.0|0.79|2.01|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||2.01|0.79|
70985984|NCT00700752|141481502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1636|STANDARD_ERROR_OF_MEAN|0.1887|||TWO_SIDED|95.0|0.789|1.1636|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus balafilcon A.|Alternative hypothesis is senofilcon A is superior to balafilcon A for comfort.||1.1636|0.7890|
70985985|NCT03461289|141481572|SUPERIORITY||Difference of Proportion|0.71|||<|0.0001|TWO_SIDED|95.0|0.48|0.87|||Fisher Exact||||Data for the current study were compared to historical control data (Finkel et al 2014 - PubMed 25080519) where 6 out of 23 (26.1%) babies were alive and did not need mechanical ventilation at 14 months of age.|0.87|0.48|<0.0001
70985986|NCT00916721|141481593|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Mixed Models Analysis|Multiple significance testing:we adjusted p-value by controlling the expected proportion of falsely rejected hypotheses:false discovery rate,Benjamini||||||0.05
70985987|NCT01797029|141481596|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
70985988|NCT02101411|141481663|OTHER|The Chi-squared test was used for comparisons of all categorical variables. If 20% of the cells had an expected value \< 5, then Fisher's exact test was used.|Hazard Ratio (HR)|1.19|STANDARD_DEVIATION|0.005||0.002|TWO_SIDED|||||The Chi-squared test was used for comparisons of all categorical variables. If 20% of the cells had an expected value \< 5, then Fisher's exact test was used.|Chi-squared|The differences among the three PRU groups (\<85, 85-208,\>208) and ADEs were compared using the Chi-squared test.||The differences among the three PRU groups (\<85, 85-208,\>208) and MACE rate at 24 months were compared using the Chi-squared test. was recorded.||||0.002
71037769|NCT00112437|141582567|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.27|||||TWO_SIDED|95.0|-2.28|-0.27||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on distal forearm BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase distal forearm BMD compared to placebo over 12 months.||-0.27|-2.28|
71097980|NCT01292473|141704214|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Refer to the Type-I error control plan.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg.||||<0.0001
70985989|NCT02101411|141481663|OTHER|The Chi-squared test was used for comparisons of all categorical variables. If 20% of the cells had an expected value \< 5, then Fisher's exact test was used.|Hazard Ratio (HR)|1.02|STANDARD_DEVIATION|0.005||0.002|TWO_SIDED|||||The Chi-squared test was used for comparisons of all categorical variables. If 20% of the cells had an expected value \< 5, then Fisher's exact test was used.|Chi-squared|||The differences among the three PRU groups (\<85, 85-208,\>208) and ADEs were compared using the Chi-squared test.||||0.002
70985990|NCT03242759|141481671|OTHER|||||||0.505|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.505
70985991|NCT03242759|141481671|OTHER|||||||0.181|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.181
70985992|NCT03242759|141481672|OTHER|||||||0.571|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.571
70985993|NCT03242759|141481672|OTHER|||||||0.232|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.232
70985994|NCT03242759|141481673|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||< 0.001
70985995|NCT03242759|141481673|OTHER|||||||0.375|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.375
70985996|NCT03242759|141481674|OTHER|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.027
70985997|NCT03242759|141481674|OTHER|||||||0.938|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.938
70985998|NCT03242759|141481675|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.001
70985999|NCT03242759|141481675|OTHER|||||||0.048|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.048
70986000|NCT03242759|141481676|OTHER|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.018
70986001|NCT03242759|141481676|OTHER|||||||0.125|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.125
70986002|NCT03242759|141481677|OTHER|||||||0.073|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.073
70986003|NCT03242759|141481677|OTHER|||||||0.755|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.755
70986004|NCT03242759|141481678|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||< 0.001
70986005|NCT03242759|141481678|OTHER|||||||0.281|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.281
70986006|NCT03242759|141481679|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||< 0.001
70986007|NCT03242759|141481679|OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.008
70986008|NCT03242759|141481680|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||< 0.001
70986009|NCT03242759|141481680|OTHER|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.031
70986010|NCT03242759|141481682|OTHER||||||<|0.001|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||< 0.001
70986011|NCT03242759|141481682|OTHER|||||||0.939|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.939
70986012|NCT03242759|141481683|OTHER|||||||0.169|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.169
70986013|NCT03242759|141481683|OTHER|||||||0.545|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.545
70986014|NCT03242759|141481684|OTHER|||||||0.333|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.333
70986015|NCT03242759|141481684|OTHER|||||||0.786|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.786
70986016|NCT03242759|141481685|OTHER|||||||0.245|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.245
70986017|NCT03242759|141481685|OTHER|||||||0.454|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.454
70986018|NCT03242759|141481686|OTHER|||||||0.543|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.543
70986019|NCT03242759|141481686|OTHER|||||||0.733|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.733
70986020|NCT03242759|141481687|OTHER|||||||0.046|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.046
71097981|NCT05463705|141704263|EQUIVALENCE|We estimated that 178 providers caring for 1,249 eligible patients would provide 80% power to observe an 11 percentage-point difference in prescribing rates between each intervention arm and control, assuming a control arm prescribing rate of 30%, an ICC of 0.07 (estimated based on prior studies in this system), an average of 7 patients per provider, and a type I error rate of 5%.|Odds Ratio (OR)|1.31|||||TWO_SIDED|95.0|0.88|1.96||||||||1.96|0.88|
71097982|NCT05463705|141704263|EQUIVALENCE|We estimated that 178 providers caring for 1,249 eligible patients would provide 80% power to observe an 11 percentage-point difference in prescribing rates between each intervention arm and control, assuming a control arm prescribing rate of 30%, an ICC of 0.07 (estimated based on prior studies in this system),72,73 an average of 7 patients per provider, and a type I error rate of 5%.|Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.66|1.52||||||||1.52|0.66|
71097983|NCT05463705|141704264|SUPERIORITY|We estimated that 178 providers caring for 1,249 eligible patients would provide 80% power to observe an 11 percentage-point difference in prescribing rates between each intervention arm and control, assuming a control arm prescribing rate of 30%, an ICC of 0.07 (estimated based on prior studies in this system), an average of 7 patients per provider, and a type I error rate of 5%.|Odds Ratio (OR)|1.17|||||TWO_SIDED|95.0|0.83|1.61||||||||1.61|0.83|
70986021|NCT03242759|141481687|OTHER|||||||0.898|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.898
70986022|NCT04430582|141481697|OTHER|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.90
70986023|NCT04430582|141481698|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
70986024|NCT04430582|141481699|OTHER|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
70986025|NCT04430582|141481700|OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||0.51
70986026|NCT04430582|141481701|OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.70
70986027|NCT04430582|141481702|OTHER|||||||0.95|||||||Kruskal-Wallis|||||||0.95
70986028|NCT04430582|141481703|OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
70986029|NCT04430582|141481704|OTHER|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||||||0.85
70986030|NCT04430582|141481705|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
70986031|NCT04430582|141481706|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
70986032|NCT04430582|141481707|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
70986033|NCT04430582|141481708|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
70986034|NCT04430582|141481709|OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.30
70986035|NCT04430582|141481710|OTHER|||||||0.045|||||||Wilcoxon (Mann-Whitney)|||||||0.045
70986036|NCT04430582|141481711|OTHER|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
70986037|NCT02522481|141481712|SUPERIORITY|||||||0.0896|||||||McNemar|||Sensitivity: superiority test comparing CE-DSE and UE-DSE based on the difference||||0.0896
70986038|NCT02522481|141481712|SUPERIORITY||||||<|0.0001|||||||McNemar|||Specificity: superiority test comparing CE-DSE and UE-DSE based on the difference||||<0.0001
70986039|NCT01240811|141481762|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||ANOVA|||||||0.80
70986040|NCT01240811|141481762|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||ANOVA|||||||0.97
70986041|NCT01240811|141481763|SUPERIORITY|||||||0.08|||||||Kruskal-Wallis|||Difference in paired change in Nugent score from baseline to 2 months||||0.08
70986042|NCT01240811|141481764|SUPERIORITY|||||||0.46|||||||Kruskal-Wallis|||Change in quantity of H2O2 producing Lactobacilli species by qPCR||||0.46
70986043|NCT01240811|141481764|SUPERIORITY|||||||0.62|||||||Kruskal-Wallis|||Change in quantity of Garnerella vaginalis species by qPCR||||0.62
70986044|NCT00500149|141481778|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 1.5 hours post-dose||||<0.0001
70986045|NCT00500149|141481778|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 2.5 hours post-dose||||<0.0001
70986046|NCT00500149|141481778|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 5.0 hours post-dose||||<0.0001
70986047|NCT00500149|141481778|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 7.5 hours post-dose||||<0.0001
71037770|NCT00112437|141582568|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-57.86|||<=|0.001|TWO_SIDED|95.0|-72.33|-43.38||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 12 months.||-43.38|-72.33|<=0.001
71097984|NCT05463705|141704264|EQUIVALENCE|We estimated that 178 providers caring for 1,249 eligible patients would provide 80% power to observe an 11 percentage-point difference in prescribing rates between each intervention arm and control, assuming a control arm prescribing rate of 30%, an ICC of 0.07 (estimated based on prior studies in this system), an average of 7 patients per provider, and a type I error rate of 5%.|Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.64|1.3||||||||1.30|0.64|
71097985|NCT05463705|141704265|SUPERIORITY||Difference in HbA1c %|0.18|||||TWO_SIDED|95.0|-0.07|0.43||||||||0.43|-0.07|
71097986|NCT05463705|141704265|SUPERIORITY||Difference in HbA1c %|0.06|||||TWO_SIDED|95.0|-0.22|0.34||||||||0.34|-0.22|
71097987|NCT02046200|141704317|SUPERIORITY_OR_OTHER|||||||0.0563|||||||ANOVA|||||||0.0563
71097988|NCT02046200|141704318|SUPERIORITY_OR_OTHER|||||||0.0342|||||||ANOVA|||||||0.0342
71097989|NCT02046200|141704319|SUPERIORITY_OR_OTHER|||||||0.1597|||||||ANOVA|||||||0.1597
71097990|NCT02046200|141704320|SUPERIORITY_OR_OTHER|||||||0.7617|||||||ANOVA|||||||0.7617
71097991|NCT02046200|141704321|SUPERIORITY_OR_OTHER|||||||0.93|||||||ANOVA|||||||0.93
71097992|NCT02046200|141704322|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANOVA|||||||0.95
71097993|NCT02046200|141704323|SUPERIORITY_OR_OTHER|||||||0.43|||||||ANOVA|||||||0.43
71097994|NCT02046200|141704324|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANOVA|||||||0.06
71097995|NCT02046200|141704325|SUPERIORITY_OR_OTHER|||||||0.21|||||||ANOVA|||||||0.21
71097996|NCT02046200|141704326|SUPERIORITY_OR_OTHER|||||||0.09|||||||ANOVA|||||||0.09
71097997|NCT02046200|141704327|SUPERIORITY_OR_OTHER|||||||0.99|||||||ANOVA|||||||0.99
71097998|NCT01691482|141704334|SUPERIORITY_OR_OTHER||Adjusted Mean|0.058|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.049|0.067|||||Treatment: A/S alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.067|0.049|
71097999|NCT01691482|141704334|SUPERIORITY_OR_OTHER||Adjusted Mean|0.071|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.062|0.08|||||Treatment: ipratropium alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.080|0.062|
71098000|NCT01691482|141704334|SUPERIORITY_OR_OTHER||Adjusted Mean|0.053|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.044|0.062|||||Treatment: A+I. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.062|0.044|
71098001|NCT01691482|141704334|SUPERIORITY_OR_OTHER||Slope|0.062|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.053|0.071|||||Treatment: I+A. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.071|0.053|
71098002|NCT01691482|141704338|SUPERIORITY_OR_OTHER||Adjusted Mean|0.058|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.049|0.067|||||Treatment: A/S alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.067|0.049|
71098003|NCT01691482|141704338|SUPERIORITY_OR_OTHER||Adjusted Mean|0.071|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.062|0.08|||||Treatment: ipratropium alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.080|0.062|
71098004|NCT01691482|141704338|SUPERIORITY_OR_OTHER||Adjusted Mean|0.053|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.044|0.062|||||Treatment: A+I. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.062|0.044|
71098005|NCT01691482|141704338|SUPERIORITY_OR_OTHER||Adjusted Mean|0.062||||||95.0|0.053|0.071|||||Treatment: I+A. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.071|0.053|
71098006|NCT01691482|141704339|SUPERIORITY_OR_OTHER||Adjusted Mean|0.067|STANDARD_ERROR_OF_MEAN|0.0045||||95.0|0.058|0.076|||||Treatment: A/S alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.076|0.058|
71098007|NCT01691482|141704339|SUPERIORITY_OR_OTHER||Adjusted Mean|0.07|STANDARD_ERROR_OF_MEAN|0.0045||||95.0|0.061|0.079|||||Treatment: ipratropium alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.079|0.061|
71098008|NCT01691482|141704339|SUPERIORITY_OR_OTHER||Adjusted Mean|0.069|STANDARD_ERROR_OF_MEAN|0.0045||||95.0|0.06|0.078|||||Treatment: A+I. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.078|0.060|
71098009|NCT01691482|141704339|SUPERIORITY_OR_OTHER||Adjusted Mean|0.064|STANDARD_ERROR_OF_MEAN|0.0045||||95.0|0.055|0.073|||||Treatment: I+A. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.073|0.055|
70986048|NCT00500149|141481778|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 10.0 hours post-dose||||<0.0001
71037771|NCT00112437|141582568|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-45.92|||<=|0.001|TWO_SIDED|95.0|-60.93|-30.91||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 12 months.||-30.91|-60.93|<=0.001
71037772|NCT00112437|141582568|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-31.84|||<=|0.001|TWO_SIDED|95.0|-48.11|-15.58||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 12 months.||-15.58|-48.11|<=0.001
71037773|NCT00112437|141582568|SUPERIORITY_OR_OTHER||Difference in Least Square Means|11.17||||0.249|TWO_SIDED|95.0|-0.94|43.24||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 12 months.||43.24|-0.94|0.249
71037774|NCT00112437|141582569|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-56.33|||<=|0.001||95.0|-75.86|-36.81||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation from difference in log-fraction)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 12 months.||-36.81|-75.86|<=0.001
71037775|NCT00112437|141582569|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-35.57|||<=|0.001||95.0|-56.63|-14.51||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Square Means (back-transformation from difference in log-fraction)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 12 months.||-14.51|-56.63|<=0.001
71037776|NCT00112437|141582569|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-21.66||||0.08||95.0|-44.54|1.23||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation from difference in log-fraction)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 12 months.||1.23|-44.54|0.080
71098010|NCT01691482|141704340|SUPERIORITY_OR_OTHER||Adjusted Mean|0.228|STANDARD_ERROR_OF_MEAN|0.014||||95.0|0.2|0.255|||||Treatment: A/S alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.255|0.200|
71098011|NCT01691482|141704340|SUPERIORITY_OR_OTHER||Adjusted Mean|0.231|STANDARD_ERROR_OF_MEAN|0.014||||95.0|0.203|0.258|||||Treatment: ipratropium alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.258|0.203|
71098012|NCT01691482|141704340|SUPERIORITY_OR_OTHER||Adjusted Mean|0.232|STANDARD_ERROR_OF_MEAN|0.014||||95.0|0.204|0.259|||||Treatment: A+I. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.259|0.204|
70986049|NCT00500149|141481778|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 12.0 hours post-dose||||<0.0001
70986050|NCT00500149|141481778|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 13.0 hours post-dose||||<0.0001
70986051|NCT00500149|141481779|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 1.5 hours post-dose||||< 0.0001
70986052|NCT00500149|141481779|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 2.5 hours post-dose||||<0.0001
71037777|NCT00112437|141582569|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|19.7|||||TWO_SIDED|95.0|-8.48|47.88||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation from difference in log-fraction)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 12 months.||47.88|-8.48|
71037778|NCT00112437|141582570|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-18.28||||0.004|TWO_SIDED|95.0|-35.82|-0.74||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-DPyr) over 12 months.||-0.74|-35.82|0.004
71037779|NCT00112437|141582570|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.26||||0.344|TWO_SIDED|95.0|-19.9|17.39||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-DPyr) over 12 months.||17.39|-19.90|0.344
71037780|NCT00112437|141582570|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.33|||||TWO_SIDED|95.0|-20.55|17.89||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-DPyr) over 12 months.||17.89|-20.55|
71098013|NCT01691482|141704340|SUPERIORITY_OR_OTHER||Adjusted Mean|0.217|STANDARD_ERROR_OF_MEAN|0.014||||95.0|0.19|0.245|||||Treatment: I+A. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.245|0.190|
71098014|NCT04576949|141704377|SUPERIORITY||Odds Ratio (OR)|8.0|||<|0.0001|TWO_SIDED|95.0|3.94|16.25||Two-sided, calculated by exact computations with clinical site as a stratifier.|exact computations||Stratified by site|Abstinence from Week 3 to Week 6||16.25|3.94|< 0.0001
70986053|NCT00500149|141481779|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 5.0 hours post-dose||||<0.0001
70986054|NCT00500149|141481779|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 7.5 hours post-dose||||<0.0001
70986055|NCT00500149|141481779|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 10.0 hours post-dose||||<0.0001
70986056|NCT00500149|141481779|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 12.0 hours post-dose||||<0.001
70986057|NCT00500149|141481779|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 13.0 hours post-dose||||<0.0001
70986058|NCT00521339|141481807|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
70986059|NCT00521339|141481808|SUPERIORITY_OR_OTHER_LEGACY|||||||0.074|||||||Wilcoxon (Mann-Whitney)|||||||0.074
70986060|NCT00521339|141481809|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||||||0.018
71037781|NCT00112437|141582570|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|28.15|||||TWO_SIDED|95.0|5.84|50.46||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-DPyr) over 12 months.||50.46|5.84|
71037782|NCT00112437|141582571|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-15.57|||<=|0.001|TWO_SIDED|95.0|-26.11|-5.04||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation from difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 12 months.||-5.04|-26.11|<=0.001
71037783|NCT00112437|141582571|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|5.43||||0.645|TWO_SIDED|95.0|-6.02|16.89||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation from difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 12 months.||16.89|-6.02|0.645
71037784|NCT00112437|141582571|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|11.73|||||TWO_SIDED|95.0|-0.47|23.92||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation from difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 12 months.||23.92|-0.47|
70986061|NCT00521339|141481810|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
70986062|NCT00521339|141481811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.632|||||||Wilcoxon (Mann-Whitney)|||||||0.632
70986063|NCT00521339|141481812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.242|||||||Wilcoxon (Mann-Whitney)|||||||0.242
70986064|NCT00521339|141481813|SUPERIORITY_OR_OTHER_LEGACY|||||||0.329|||||||Wilcoxon (Mann-Whitney)|||||||0.329
70986065|NCT00521339|141481814|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.130
70986066|NCT00521339|141481816|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.008
70986067|NCT00521339|141481817|SUPERIORITY_OR_OTHER_LEGACY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||||||0.031
70986068|NCT00521339|141481818|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
70986069|NCT00521339|141481820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
70986070|NCT00521339|141481821|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||||||0.015
70986071|NCT00521339|141481822|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||||||0.018
70986072|NCT00521339|141481823|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||||||0.018
70986073|NCT00521339|141481824|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70986074|NCT00521339|141481825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||||||0.031
70986075|NCT00521339|141481826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.217|||||||Wilcoxon (Mann-Whitney)|||||||0.217
70986076|NCT00521339|141481827|SUPERIORITY_OR_OTHER_LEGACY|||||||0.539|||||||Wilcoxon (Mann-Whitney)|||||||0.539
70986077|NCT00521339|141481828|SUPERIORITY_OR_OTHER_LEGACY|||||||0.169|||||||Wilcoxon (Mann-Whitney)|||||||0.169
70986078|NCT00521339|141481829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.339|||||||Wilcoxon (Mann-Whitney)|||||||0.339
70986079|NCT00521339|141481830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.898|||||||Wilcoxon (Mann-Whitney)|||||||0.898
70986080|NCT00521339|141481831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.622|||||||Wilcoxon (Mann-Whitney)|||||||0.622
70986081|NCT00103194|141481848|SUPERIORITY_OR_OTHER||PSA response rate|0.0|||||TWO_SIDED|90.0|0.0|8.2||||||||8.2|0|
71037785|NCT00112437|141582571|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|44.85|||||TWO_SIDED|95.0|30.55|59.16||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation from difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 12 months.||59.16|30.55|
70986082|NCT00103194|141481849|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Mixed Models Analysis|The analysis is testing the null hypothesis that there is no difference between the pre-treatment and post-treatment PSA slopes.||||||0.006
70986083|NCT01996319|141481855|SUPERIORITY_OR_OTHER||null hypoth|0.2021|||<|0.0001|TWO_SIDED|95.0|0.1583|0.246|||ANCOVA|||||0.2460|0.1583|<0.0001
70986084|NCT01996319|141481856|SUPERIORITY_OR_OTHER||Null hypoth|36.7126||||0.0399|TWO_SIDED|95.0|1.7241|71.7011|||ANCOVA|||||71.7011|1.7241|0.0399
70986085|NCT00591227|141481863|SUPERIORITY_OR_OTHER_LEGACY|||||||0.58||95.0|||||t-test, 1 sided|||||||0.58
70986086|NCT00117338|141481897|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01||||0.775||95.0|-0.06|0.08|||ANCOVA|Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate||||0.08|-0.06|0.775
70986087|NCT00117338|141481898|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.931||95.0|-0.41|0.45|||ANCOVA|Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate||||0.45|-0.41|0.931
70986088|NCT00117338|141481899|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.99||||0.975||95.0|0.61|1.61|||Regression, Logistic|Model terms: treatment and baseline FEV1 as covariate||||1.61|0.61|0.975
70986089|NCT00117338|141481900|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.612||95.0|-0.05|0.09|||ANCOVA|Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate||||0.09|-0.05|0.612
70986090|NCT00117338|141481901|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01||||0.774||95.0|-0.06|0.08|||ANCOVA|Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate||||0.08|-0.06|0.774
70986091|NCT00117338|141481902|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04||||0.173||95.0|-0.02|0.11|||ANCOVA|Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate||||0.11|-0.02|0.173
70986092|NCT00117338|141481903|SUPERIORITY_OR_OTHER_LEGACY|||||||0.58||95.0|||||ANCOVA|ANCOVA model (Nonparametric) based on Tukey's normalized ranks with terms treatment, region (US, non-US) and baseline FEV1 as covariate||||||0.580
70986093|NCT02202031|141481910|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.6222|TWO_SIDED|95.0|-0.73|1.21|||ANCOVA|change from baseline, adjusted for baseline value||||1.21|-0.73|0.6222
70986094|NCT02202031|141481911|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.7695|TWO_SIDED|95.0|-0.64|0.47|||ANCOVA|change from baseline, adjusted for baseline value||||0.47|-0.64|0.7695
70986095|NCT02202031|141481912|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.6456|TWO_SIDED|95.0|-0.24|0.39|||ANCOVA|change from baseline value, adjusted for baseline value||||0.39|-0.24|0.6456
70986096|NCT02202031|141481913|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.919|TWO_SIDED|95.0|-0.66|0.6|||ANCOVA|change from baseline, adjusted for baseline value||||0.60|-0.66|0.9190
70986097|NCT02202031|141481914|SUPERIORITY||Mean Difference (Final Values)|1.16||||0.5358|TWO_SIDED|95.0|-2.51|4.84|||ANCOVA|change from baseline, adjusted for baseline value.||||4.84|-2.51|0.5358
70986098|NCT02202031|141481915|SUPERIORITY||Mean Difference (Final Values)|1.72||||0.4663|TWO_SIDED|95.0|-2.9|6.34|||ANCOVA|change from baseline, adjusted for baseline value||||6.34|-2.90|0.4663
70986099|NCT02202031|141481916|SUPERIORITY||Mean Difference (Final Values)|2.17||||0.3134|TWO_SIDED|95.0|-2.05|6.38|||ANCOVA|change from baseline, adjusted for baseline value||||6.38|-2.05|0.3134
70986100|NCT02202031|141481917|SUPERIORITY||Mean Difference (Final Values)|-1.76||||0.5146|TWO_SIDED|95.0|-7.05|3.53|||ANCOVA|change from baseline, adjusted for baseline value||||3.53|-7.05|0.5146
70986101|NCT02202031|141481918|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.3611|TWO_SIDED|95.0|-0.44|0.16|||ANCOVA|change from baseline, adjusted for baseline value||||0.16|-0.44|0.3611
70986102|NCT02202031|141481919|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.6722|TWO_SIDED|95.0|-2.43|1.57|||ANCOVA|change from baseline, adjusted for baseline value||||1.57|-2.43|0.6722
70986103|NCT02202031|141481920|SUPERIORITY||Mean Difference (Final Values)|-0.67||||0.0786|TWO_SIDED|95.0|-1.4|0.07|||ANCOVA|change from baseline, adjusted for baseline value||||0.07|-1.4|0.0786
70986104|NCT02202031|141481921|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.2284|TWO_SIDED|95.0|-2.87|0.79|||ANCOVA|change from baseline, adjusted for baseline value||||0.79|-2.87|0.2284
70986105|NCT02202031|141481922|SUPERIORITY||Mean Difference (Final Values)|-1.71||||0.0335|TWO_SIDED|95.0|-3.28|-0.13|||ANCOVA|change from baseline, adjusted for baseline value||||-0.13|-3.28|0.0335
70986106|NCT02202031|141481923|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.8408|TWO_SIDED|95.0|-0.66|0.81|||ANCOVA|change from baseline, adjusted for baseline value||||0.81|-0.66|0.8408
70986107|NCT02202031|141481924|SUPERIORITY|adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic|Mean Difference (Final Values)|0.14||||0.5578|TWO_SIDED|95.0|-0.32|0.6|||ANCOVA|||||0.60|-0.32|0.5578
70986108|NCT02202031|141481925|SUPERIORITY|||||||0.5578|||||||ANCOVA|Adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.||||||0.5578
70986109|NCT02202031|141481926|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.7301|TWO_SIDED|95.0|-0.79|0.31|||ANCOVA|adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.||||0.31|-0.79|0.7301
70986110|NCT02202031|141481927|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.6646|TWO_SIDED|95.0|-0.89|0.04|||ANCOVA|adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic||||0.04|-0.89|0.6646
70986111|NCT02202031|141481928|SUPERIORITY|||||||0.4993|||||||ANCOVA|Adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.||||||0.4993
70986112|NCT02202031|141481929|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.7506|TWO_SIDED|95.0|-3.05|4.23|||ANCOVA|adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.||||4.23|-3.05|0.7506
70986113|NCT02202031|141481930|SUPERIORITY||Mean Difference (Final Values)|-1.55||||0.6268|TWO_SIDED|95.0|-6.98|3.87|||ANCOVA|adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.||||3.87|-6.98|0.6268
70986114|NCT02853331|141481956|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.00012|TWO_SIDED|95.0|0.56|0.84|||Log Rank||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World).|||0.84|0.56|0.00012
70986115|NCT02853331|141481957|SUPERIORITY||Hazard Ratio (HR)|0.53||||5e-05|TWO_SIDED|95.0|0.38|0.74|||Log Rank||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World).|||0.74|0.38|0.00005
70986116|NCT02853331|141481958|SUPERIORITY||Difference in percentages|23.6|||<|0.0001|TWO_SIDED|95.0|17.2|29.9|||Miettinen & Nurminen method|H0: difference in %=0 versus H1: difference in % \>0|Difference in percentages based on Miettinen \& Nurminen method stratified by IMDC risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World).|||29.9|17.2|<0.0001
70986117|NCT02853331|141481959|SUPERIORITY||Difference in percentages|11.0|||||TWO_SIDED|95.0|4.8|17.0|||||Difference in percentages based on Miettinen \& Nurminen method stratified by IMDC risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World).|||17.0|4.8|
70986118|NCT00844428|141481980|SUPERIORITY_OR_OTHER||Percent of TMA event-free responders|80.0|||||TWO_SIDED|95.0|56.0|94.0||||||"With a total of 20 patients enrolled between both protocols and, assuming that the true expected probability of TMA Event-Free for eculizumab-treated patients is 40%, then the study had 93.5% power to detect a statistically significant difference. Up to approximately 30 patients were to be enrolled.~All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS."||94|56|
70986119|NCT00844428|141481981|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||99|68|
70986120|NCT00844428|141481982|SUPERIORITY_OR_OTHER||Percent of complete TMA response|25.0|||||TWO_SIDED|95.0|9.0|49.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||49|9|
70986121|NCT00844428|141481983|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.29|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||||<0.0001
70986122|NCT00844428|141481984|SUPERIORITY_OR_OTHER||LS mean change from baseline|6.75||||0.5423|TWO_SIDED|95.0|-15.73|29.23|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years||29.23|-15.73|0.5423
70986123|NCT00844428|141481985|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years||99|68|
70986124|NCT00844428|141481986|SUPERIORITY_OR_OTHER||Percent of TMA event-free responders|95.0|||||TWO_SIDED|95.0|75.0|100.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||100|75|
70986125|NCT00844428|141481987|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||99|68|
70986126|NCT00844428|141481988|SUPERIORITY_OR_OTHER||Percent of complete TMA response|55.0|||||TWO_SIDED|95.0|32.0|77.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||77|32|
70986127|NCT00844428|141481989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||||<0.0001
70986128|NCT00844428|141481990|SUPERIORITY_OR_OTHER||LS mean change from baseline|-3.68||||0.7307|TWO_SIDED|95.0|-25.15|17.79|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||17.79|-25.15|0.7307
70986129|NCT00844428|141481991|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years||99|68|
71098015|NCT04576949|141704377|SUPERIORITY||Marginal Difference in Proportions|0.21|||<|0.0001|TWO_SIDED|95.0|0.16|0.25||p-value for difference in proportions|Cochran-Mantel-Haenszel|||||0.25|0.16|<0.0001
71098016|NCT04576949|141704378|SUPERIORITY||Odds Ratio (OR)|6.29|||<|0.0001|TWO_SIDED|95.0|3.69|11.57||Two-sided, calculated by exact computations with clinical site as a stratifier.|exact computations||Stratified by site|Abstinence from Week 9 to Week 12||11.57|3.69|< 0.0001
71098017|NCT04576949|141704378|SUPERIORITY||Marginal Difference in Proportions|0.26|||<|0.0001|TWO_SIDED|95.0|0.2|0.3||p-value for difference in proportions|Cochran-Mantel-Haenszel|||||0.30|0.20|<0.0001
70986130|NCT03290300|141481993|OTHER||||||<|0.0001||||||The pre-specified threshold for statistical significance was p\<0.05.|ANOVA|Repeated measures ANOVA with multiple comparisons to baseline||||||<0.0001
70986131|NCT01276847|141481998|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 1||||0.016
70986132|NCT01276847|141481998|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 2||||0.007
70986133|NCT01276847|141481998|SUPERIORITY_OR_OTHER|||||||0.00015||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 4||||0.00015
70986134|NCT01276847|141481998|SUPERIORITY_OR_OTHER|||||||0.000184||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 16||||0.000184
70986135|NCT01276847|141481999|SUPERIORITY_OR_OTHER|||||||0.397||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 1||||0.397
70986136|NCT01276847|141481999|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 2||||0.010
70986137|NCT01276847|141481999|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 4||||0.002
70986138|NCT01276847|141481999|SUPERIORITY_OR_OTHER|||||||0.000215||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 16||||0.000215
70986139|NCT01276847|141482000|SUPERIORITY_OR_OTHER|||||||0.787||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 1||||0.787
70986140|NCT01276847|141482000|SUPERIORITY_OR_OTHER|||||||0.577||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 2||||0.577
70986141|NCT01276847|141482000|SUPERIORITY_OR_OTHER|||||||0.053||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 4||||0.053
70986142|NCT01276847|141482000|SUPERIORITY_OR_OTHER|||||||0.098||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 16||||0.098
71008800|NCT02055976|141525256|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-47.8521|STANDARD_ERROR_OF_MEAN|3.05746|<|0.001|TWO_SIDED|95.0|-53.92668|-41.77751|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-41.77751|-53.92668|<0.001
71008801|NCT02055976|141525256|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-48.65686|STANDARD_ERROR_OF_MEAN|3.02097|<|0.001|TWO_SIDED|95.0|-54.6606|-42.65313|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-42.65313|-54.66060|<0.001
71098018|NCT04576949|141704379|SUPERIORITY||Odds Ratio (OR)|3.67||||0.0016|TWO_SIDED|95.0|1.5|10.24||Two-sided, calculated by exact computations with clinical site as a stratifier.|exact computations|||Abstinence from Week 6 to Week 24|Stratified by site|10.24|1.50|0.0016
70986143|NCT01899144|141482007|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|22.6|STANDARD_ERROR_OF_MEAN|4.87|<|0.0001|TWO_SIDED|95.0|13.0|32.2|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||32.20|13.00|<0.0001
71098019|NCT04576949|141704379|SUPERIORITY||Marginal Difference in Proportions|0.06||||0.0015|TWO_SIDED|95.0|0.03|0.09||p-value for difference in proportions|Cochran-Mantel-Haenszel|||||0.09|0.03|0.0015
70986144|NCT01899144|141482007|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.2|STANDARD_ERROR_OF_MEAN|4.87|<|0.0001|TWO_SIDED|95.0|11.6|30.81|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||30.81|11.6|<0.0001
70986145|NCT01899144|141482007|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|23.7|STANDARD_ERROR_OF_MEAN|4.85|<|0.0001|TWO_SIDED|95.0|14.13|33.23|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||33.23|14.13|<0.0001
70986146|NCT01899144|141482007|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.5|STANDARD_ERROR_OF_MEAN|4.85||0.0107|TWO_SIDED|95.0|2.93|22.05|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||22.05|2.93|0.0107
70986147|NCT01899144|141482007|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|4.88||0.7772|TWO_SIDED|95.0|-11.0|8.23||0.05 level of significance|ANOVA||90 mcg - 180 mcg|Pre-specified, exploratory analysis||8.23|-11.00|0.7772
70986148|NCT01899144|141482007|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.2|STANDARD_ERROR_OF_MEAN|4.87||0.0226|TWO_SIDED|95.0|-20.8|-1.59||0.05 level of significance|ANOVA||90 mcg - 180 mcg|Pre-specified, exploratory analysis||-1.59|-20.80|0.0226
71098020|NCT04576949|141704380|SUPERIORITY||Odds Ratio (OR)|5.32|||<|0.0001|TWO_SIDED|95.0|2.81|11.09||Two-sided, calculated by exact computations with clinical site as a stratifier.|exact computations||Stratified by site|Abstinence from Week 12 to Week 24||11.09|2.81|< 0.0001
71098021|NCT04576949|141704380|SUPERIORITY||Marginal Difference in Proportions|0.16|||<|0.0001|TWO_SIDED|95.0|0.11|0.2||p-value for difference in proportions|Cochran-Mantel-Haenszel|||||0.20|0.11|<.0001
71098022|NCT04576949|141704381|SUPERIORITY||Odds Ratio (OR)|1.31||||0.3484|TWO_SIDED|95.0|0.75|2.33||Two-sided, calculated by exact computations with clinical site as a stratifier.|exact computations||Stratified by site|Relapse free from Week 6 to Week 24||2.33|0.75|0.3484
71098023|NCT00407030|141704382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|||<|0.001|TWO_SIDED|95.0|-12.0|-5.9||Due to the hierarchical testing no adjustment of type I error was necessary.|ANCOVA|Independent variables in the model were treatment, baseline TWSTRS-Total score, gender, age, pre-treatment of cervical dystonia, and pooled center.||Hierarchical testing: Primary null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to placebo. Rejection of 1st hypothesis lead to test of 2nd null hypothesis: incobotulinumtoxinA (Xeomin) (120 Units) identical to placebo. Rejection of 2nd hypothesis lead to test of 3rd null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to incobotulinumtoxinA (Xeomin) (120 Units). 3 separate models were used to test these hypotheses which results in different LS means estimates.||-5.9|-12.0|<0.001
71098024|NCT00407030|141704388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5|||<|0.001|TWO_SIDED|95.0|-10.4|-4.6||Due to the hierarchical testing no adjustment of type I error was necessary.|ANCOVA|Independent variables in the model were treatment, baseline TWSTRS-Total score, gender, age, pre-treatment of cervical dystonia, and pooled center.||Hierarchical testing: Primary null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to placebo. Rejection of 1st hypothesis lead to test of 2nd null hypothesis: incobotulinumtoxinA (Xeomin) (120 Units) identical to placebo. Rejection of 2nd hypothesis lead to test of 3rd null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to incobotulinumtoxinA (Xeomin) (120 Units). 3 separate models were used to test these hypotheses which results in different LS means estimates.||-4.6|-10.4|<0.001
70986149|NCT01899144|141482008|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|0.26|0.64|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||0.64|0.26|<0.0001
70986150|NCT01899144|141482008|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|0.21|0.59|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||0.59|0.21|<0.0001
70986151|NCT01899144|141482008|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|0.26|0.64|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||0.64|0.26|<0.0001
71008802|NCT02055976|141525256|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-33.5292|STANDARD_ERROR_OF_MEAN|2.96599|<|0.001|TWO_SIDED|95.0|-39.42015|-27.63826|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-27.63826|-39.42015|<0.001
71008803|NCT02055976|141525256|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-43.8568|STANDARD_ERROR_OF_MEAN|3.00531|<|0.001|TWO_SIDED|95.0|-49.82617|-37.88744|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-37.88744|-49.82617|<0.001
71008804|NCT02055976|141525256|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-46.36865|STANDARD_ERROR_OF_MEAN|3.03981|<|0.001|TWO_SIDED|95.0|-52.40589|-40.33142|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-40.33142|-52.40589|<0.001
71008805|NCT02055976|141525256|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-38.06019|STANDARD_ERROR_OF_MEAN|3.1361|<|0.001|TWO_SIDED|95.0|-44.29176|-31.82863|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-31.82863|-44.29176|<0.001
71008806|NCT02055976|141525256|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-48.57807|STANDARD_ERROR_OF_MEAN|3.1135|<|0.001|TWO_SIDED|95.0|-54.76397|-42.39217|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-42.39217|-54.76397|<0.001
71008807|NCT02055976|141525256|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-51.87214|STANDARD_ERROR_OF_MEAN|3.09363|<|0.001|TWO_SIDED|95.0|-58.01968|-45.7246|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-45.72460|-58.01968|<0.001
71008808|NCT02055976|141525258|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.33157|STANDARD_ERROR_OF_MEAN|0.02639|<|0.001|TWO_SIDED|95.0|-0.38399|-0.27916|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.27916|-0.38399|<0.001
71008809|NCT02055976|141525258|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.44402|STANDARD_ERROR_OF_MEAN|0.02682|<|0.001|TWO_SIDED|95.0|-0.49727|-0.39077|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.39077|-0.49727|<0.001
71008810|NCT02055976|141525258|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.48314|STANDARD_ERROR_OF_MEAN|0.02698|<|0.001|TWO_SIDED|95.0|-0.53671|-0.42956|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.42956|-0.53671|<0.001
71098025|NCT00407030|141704389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.447|TWO_SIDED|95.0|-2.1|4.6||Due to the hierarchical testing no adjustment of type I error was necessary.|ANCOVA|Independent variables in the model were treatment, baseline TWSTRS-Total score, gender, age, pre-treatment of cervical dystonia, and pooled center.||Hierarchical testing: Primary null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to placebo. Rejection of 1st hypothesis lead to test of 2nd null hypothesis: incobotulinumtoxinA (Xeomin) (120 Units) identical to placebo. Rejection of 2nd hypothesis lead to test of 3rd null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to incobotulinumtoxinA (Xeomin) (120 Units). 3 separate models were used to test these hypotheses which results in different LS means estimates.||4.6|-2.1|0.447
71098026|NCT03193307|141704411|OTHER||Geometric Mean (T1/R1) ratio (%)|153.2|||||TWO_SIDED|90.0|134.34|174.7|||||"Analysis of variance (ANOVA) model including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\]) =21.4."|||174.70|134.34|
71098027|NCT03193307|141704412|OTHER||Geometric Mean (T1/R1) ratio (%)|115.91|||||TWO_SIDED|90.0|104.559|128.502|||||"Analysis of variance (ANOVA) including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\]) = 16.7."|||128.502|104.559|
71098028|NCT03193307|141704413|OTHER||Geometric Mean (T2/R2) ratio (%)|104.82|||||TWO_SIDED|90.0|102.092|107.613|||||"Analysis of variance (ANOVA) model including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\]) =4.3."|||107.613|102.092|
71098029|NCT03193307|141704414|OTHER||Geometric Mean (T2/R2) ratio (%)|102.77|||||TWO_SIDED|90.0|100.66|104.92|||||"Analysis of variance (ANOVA) model including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\]) = 3.3."|||104.92|100.66|
71098030|NCT03193307|141704415|OTHER||Geometric Mean (T2/R2) ratio (%)|114.12|||||TWO_SIDED|90.0|109.266|119.183|||||"Analysis of variance (ANOVA) model including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\])=7.0."|||119.183|109.266|
71098031|NCT03193307|141704416|OTHER||Geometric Mean (T2/R2) ratio (%)|110.7|||||TWO_SIDED|90.0|105.8|115.83|||||"Analysis of variance (ANOVA) model including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\]) = 7.3."|||115.83|105.80|
71098032|NCT03193307|141704417|OTHER||Geometric Mean (T1/R1) ratio (%)|154.15|||||TWO_SIDED|90.0|133.81|177.58|||||"Analysis of variance (ANOVA) model including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\]) = 22.4."|||177.58|133.81|
71098033|NCT03518203|141704420|EQUIVALENCE|A binomial test was used to test 6 month survival in study cohort against an 18% historical rate.|Proportion|0.714|||<|0.0001|TWO_SIDED|||||The a priori threshold was 0.05.|binomial test|||||||<0.0001
71098034|NCT04560309|141704439|SUPERIORITY|||||||0.993||||||The threshold for statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.993
71098035|NCT04560309|141704440|SUPERIORITY|||||||0.883||||||The threshold for statistical significance was p \< 0.05|Unpaired T-Test|||||||0.883
71098036|NCT04560309|141704441|SUPERIORITY|||||||0.034||||||The threshold for statistical significance was p \< 0.05|Unpaired T-Test|||||||0.034
71098037|NCT04560309|141704442|SUPERIORITY|||||||0.038||||||The threshold for statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.038
71098038|NCT04560309|141704443|SUPERIORITY|||||||0.423||||||The threshold for statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.423
71098039|NCT04560309|141704444|SUPERIORITY|||||||0.216||||||The threshold for statistical significance was p \< 0.05|Unpaired T-Test|||||||0.216
71098040|NCT04560309|141704445|SUPERIORITY|||||||0.001||||||The threshold for statistical significance was p \< 0.05|Unpaired T-Test|||||||0.001
71098041|NCT04560309|141704446|SUPERIORITY|||||||0.043||||||The threshold for statistical significance was p \< 0.05|Unpaired T-Test|||||||0.043
71098042|NCT04560309|141704447|SUPERIORITY|||||||0.011||||||The threshold for statistical significance was p \< 0.05|Unpaired T-Test|||||||0.011
71098043|NCT04560309|141704448|SUPERIORITY|||||||0.975||||||The threshold for statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.975
71098044|NCT04560309|141704449|SUPERIORITY|||||||0.031||||||The threshold for statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.031
71098045|NCT04560309|141704450|SUPERIORITY|||||||0.549||||||The threshold of statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.549
71098046|NCT04560309|141704451|SUPERIORITY|||||||0.645||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||||||0.645
71098047|NCT04560309|141704452|SUPERIORITY|||||||0.33||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||After induction to anesthesia||||0.330
71098048|NCT04560309|141704452|SUPERIORITY|||||||0.352||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||5 minutes after cardiopulmonary bypass||||0.352
71098049|NCT04560309|141704452|SUPERIORITY|||||||0.544||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||2 hours after cardiopulmonary bypass||||0.544
71098050|NCT04560309|141704452|SUPERIORITY|||||||0.022||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||6 hours after cardiopulmonary bypass||||0.022
71098051|NCT04560309|141704452|SUPERIORITY|||||||0.038||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||24 hour after cardiopulmonary bypass||||0.038
70986152|NCT01899144|141482008|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.1||0.0062|TWO_SIDED|95.0|0.08|0.45|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||0.45|0.08|0.0062
70986153|NCT01899144|141482008|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.1||0.6342|TWO_SIDED|95.0|-0.23|0.14||0.05 level of significance|ANOVA||90 mcg - 180 mcg|Pre-specified, exploratory analysis||0.14|-0.23|0.6342
70986154|NCT01899144|141482008|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.0488|TWO_SIDED|95.0|-0.38|0.0||0.05 level of significance|ANOVA||90 mcg - 180 mcg|Pre-specified, exploratory analysis||0.00|-0.38|0.0488
70986155|NCT00751881|141482012|SUPERIORITY_OR_OTHER||Relative risk reduction (%)|36.3||||0.0001|TWO_SIDED|95.0||||"Step down approach used to adjust for multiplicity:~* H1 tested first~* H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance for both comparisons ≤0.05"|Regression, Poisson||Relative risk reduction with teriflunomide 14 mg compared to placebo|"Null hypothesis:~* H1: No difference between teriflunomide 14 mg and placebo~* H2: No difference between teriflunomide 7 mg and placebo~The study was sized to have 94% power to detect a 25% relative risk reduction in ARR with teriflunomide compared to placebo at a 2-sided 0.05 significance level."||||0.0001
70986156|NCT00751881|141482012|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|22.3||||0.0183|TWO_SIDED|95.0||||"Step down approach used to adjust for multiplicity:~* H1 tested first~* H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance for both comparisons ≤0.05"|Regression, Poisson||Relative risk reduction with teriflunomide 7 mg compared to placebo|||||0.0183
70986157|NCT00751881|141482013|SUPERIORITY_OR_OTHER||Hazard ratio reduction (%)|31.5||||0.0442|TWO_SIDED|95.0||||"Step down approach:~* S1 tested only if both comparisons on the primary outcome measure were statistically significant~* S2 tested only if the comparison S1 was statistically significant~A priori threshold for statistical significance ≤0.05"|Log Rank|Two-sided Log-rank test stratified by region of enrollment and baseline EDSS stratum|Relative reduction in the hazard rate with teriflunomide 14 mg compared to placebo (estimated from a Cox proportional hazard model with treatment arm, region of enrollment and baseline EDSS stratum as covariates)|"Null hypothesis:~* S1: No difference between teriflunomide 14 mg and placebo~* S2: No difference between teriflunomide 7 mg and placebo~The study was also sized to have 75% power to detect a 37% hazard ratio reduction in time to disability progression with teriflunomide compared to placebo."||||0.0442
70986158|NCT00751881|141482013|SUPERIORITY_OR_OTHER||Hazard ratio reduction (%)|4.5||||0.762|TWO_SIDED|95.0||||"Step down approach:~* S1 tested only if both comparisons on the primary outcome measure were statistically significant~* S2 tested only if the comparison S1 was statistically significant~A priori threshold for statistical significance ≤0.05"|Log Rank|Two-sided Log-rank test stratified by region of enrollment and baseline EDSS stratum|Relative reduction in the hazard rate with teriflunomide 7 mg compared to placebo (estimated from a Cox proportional hazard model with treatment arm, region of enrollment and baseline EDSS stratum as covariates)|||||0.7620
70986159|NCT03415464|141482046|OTHER|||||||0.134|||||||Chi-squared|||||||0.134
71037786|NCT00112437|141582572|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-35.74|||<=|0.001|TWO_SIDED|95.0|-52.14|-19.33||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 12 months.||-19.33|-52.14|<=0.001
71098052|NCT04560309|141704453|SUPERIORITY|||||||0.2||||||The threshold of statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.200
71098053|NCT04560309|141704454|SUPERIORITY|||||||0.72||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||||||0.720
70986160|NCT02273323|141482055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.43|TWO_SIDED|0.23|-0.37|0.83|||Mixed Models Analysis|||Estimated effect of tea vs placebo||0.83|-0.37|0.43
70986161|NCT02273323|141482056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71||||0.2|TWO_SIDED|95.0|-0.4|1.82|||Mixed Models Analysis|Subject=random factor; treatment, on/off medication, period = fixed effects||Estimated effect of tea vs. placebo||1.82|-0.40|0.20
70986162|NCT02273323|141482057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35|||||TWO_SIDED|95.0|-5.26|2.55|||Mixed Models Analysis|||||2.55|-5.26|
70986163|NCT02273323|141482058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.16|1.37|||Mixed Models Analysis|||||1.37|-2.16|
70986164|NCT02273323|141482059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.89|||||TWO_SIDED|95.0|-4.65|0.87|||Mixed Models Analysis|||||0.87|-4.65|
70986165|NCT02273323|141482060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68|||||TWO_SIDED|95.0|-0.73|4.09|||Mixed Models Analysis|||||4.09|-0.73|
70986166|NCT03117049|141482064|SUPERIORITY||Hazard Ratio (HR)|0.56|||<|0.0001|TWO_SIDED|96.37|0.43|0.71|||Stratified log-rank test|||||0.71|0.43|<0.0001
70986167|NCT03117049|141482065|SUPERIORITY||Stratified hazard ratio|0.85|||||TWO_SIDED|95.0|0.63|1.14||||||||1.14|0.63|
70986168|NCT03117049|141482066|SUPERIORITY||Odds Ratio (OR)|1.55|||||TWO_SIDED|95.0|1.11|2.17||||||||2.17|1.11|
70986169|NCT03117049|141482067|SUPERIORITY||Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.46|1.31||||||||1.31|0.46|
71098054|NCT04560309|141704455|SUPERIORITY|||||||0.042||||||The threshold of statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.042
71098055|NCT04560309|141704456|SUPERIORITY|||||||0.044||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||||||0.044
71098056|NCT04560309|141704457|SUPERIORITY|||||||0.349||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||||||0.349
71098057|NCT04560309|141704458|SUPERIORITY|||||||0.95||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||||||0.950
71098058|NCT04560309|141704459|SUPERIORITY|The threshold of statistical significance was p \< 0.05||||||0.862|||||||Wilcoxon (Mann-Whitney)|||||||0.862
71098059|NCT04560309|141704460|SUPERIORITY|The threshold of statistical significance was p \< 0.05||||||0.075|||||||Wilcoxon (Mann-Whitney)|||||||0.075
71098060|NCT00567112|141704483|NON_INFERIORITY_OR_EQUIVALENCE|Geometric Mean Ratio of OCT (fasted)/DFC (fasted)|Geometric Mean Ratio|0.98|||>|0.2|TWO_SIDED|90.0|0.92|1.05|||ANOVA|||OCT (fasted)/DFC (fasted)||1.05|0.92|>0.200
71098061|NCT00567112|141704484|NON_INFERIORITY_OR_EQUIVALENCE|Geometric Mean Ratio of OCT (fasted)/DFC (fasted)|Geometric Mean Ratio|0.98|||>|0.2|TWO_SIDED|90.0|0.8|1.19|||ANOVA|||OCT (fasted)/DFC (fasted)||1.19|0.80|>0.200
71098062|NCT00567112|141704485|NON_INFERIORITY_OR_EQUIVALENCE|Geometric Mean Ratio of OCT (after meal)/OCT (fasted)|Geometric Mean Ratio|0.92||||0.026|TWO_SIDED|90.0|0.86|0.98|||ANOVA|||OCT (after meal)/OCT (fasted)||0.98|0.86|0.026
70986170|NCT00839098|141482070|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.27
70986171|NCT00839098|141482071|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
70986172|NCT00839098|141482072|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.04
70986173|NCT00839098|141482073|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
70986174|NCT00839098|141482074|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
70986175|NCT00839098|141482075|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||P values below 0.05 were considered statistically significant in this study.|Wilcoxon (Mann-Whitney)|||||||>0.05
70986176|NCT00839098|141482076|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
70986177|NCT00121810|141482077|SUPERIORITY_OR_OTHER||Median Difference (Net)|18.7||||0.012||95.0|4.2|33.2||P value comparing the treatment groups calculated using ANCOVA model treatment and baseline calcineurin inhibitor (cyclosporine or tacrolimus) as factors and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||The primary analysis tested the null hypothesis that mean percent change from baseline to 12 months for Group 1 (mycophenolate mofetil + sirolimus) was equal to that for Group 2 (mycophenolate mofetil + cyclosporine or tacrolimus) based on the intent-to-treat population.||33.2|4.2|0.012
70986178|NCT00121810|141482078|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.3||||0.543||95.0|-9.6|18.2||P value comparing the treatment groups calculated using ANCOVA model treatment and baseline calcineurin inhibitor (cyclosporine or tacrolimus) type as factors and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||||18.2|-9.6|0.543
70986179|NCT00121810|141482079|SUPERIORITY_OR_OTHER||Median Difference (Net)|-10.8||||0.003||95.0|-17.9|-3.7||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||6 months||-3.7|-17.9|0.003
70986180|NCT00121810|141482079|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.0||||0.108||95.0|-35.4|3.5||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||12 months||3.5|-35.4|0.108
70986181|NCT00121810|141482079|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.4||||0.039||95.0|-47.7|-1.2||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||24 months||-1.2|-47.7|0.039
70986182|NCT00121810|141482080|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.7|||<|0.001||95.0|4.1|13.3||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||6 months||13.3|4.1|<0.001
70986183|NCT00121810|141482080|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.9||||0.029||95.0|0.7|13.1||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||12 months||13.1|0.7|0.029
70986184|NCT00121810|141482080|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.8||||0.015||95.0|1.7|15.9||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||24 months||15.9|1.7|0.015
70986185|NCT00121810|141482081|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.5|||<|0.001||95.0|4.2|12.9||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||6 months||12.9|4.2|<0.001
70986186|NCT00121810|141482081|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.8||||0.059||95.0|-0.2|11.9||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||12 months||11.9|-0.2|0.059
70986187|NCT00121810|141482081|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.5||||0.036||95.0|0.5|14.5||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||24 months||14.5|0.5|0.036
70986188|NCT02260193|141482094|SUPERIORITY||Least Squares Mean Differences|0.29|||||TWO_SIDED|95.0|-0.25|0.82||||||||0.82|-0.25|
70986189|NCT02260193|141482094|SUPERIORITY||Least Squares Mean Differences|0.36|||||TWO_SIDED|95.0|-0.19|0.9||||||||0.90|-0.19|
70986190|NCT02260193|141482094|SUPERIORITY||Least Squares Mean Differences|0.07|||||TWO_SIDED|95.0|-0.48|0.61||||||||0.61|-0.48|
70986191|NCT02260193|141482095|SUPERIORITY||Least Squares Mean Differences|0.04|||||TWO_SIDED|95.0|-0.54|0.61||||||||0.61|-0.54|
71098063|NCT00567112|141704486|NON_INFERIORITY_OR_EQUIVALENCE|Geometric Mean Ratio OCT (after meal)/OCT (fasted)|Geometric Mean Ratio|0.59|||<|0.001|TWO_SIDED|90.0|0.49|0.72|||ANOVA|||OCT (after meal)/OCT (fasted)||0.72|0.49|<0.001
71098064|NCT00567112|141704487|SUPERIORITY_OR_OTHER||||||>|0.2||95.0|||||ANOVA|||OCT (fasted)/DFC (fasted)||||>0.200
70986192|NCT02260193|141482095|SUPERIORITY||Least Squares Mean Differences|0.1|||||TWO_SIDED|95.0|-0.49|0.7||||||||0.70|-0.49|
70986193|NCT02260193|141482095|SUPERIORITY||Least squares mean difference|0.07|||||TWO_SIDED|95.0|-0.53|0.66||||||||0.66|-0.53|
70986194|NCT02260193|141482096|SUPERIORITY||Least squares mean difference|-0.34|||||TWO_SIDED|95.0|-0.71|0.04||||||||0.04|-0.71|
70986195|NCT02260193|141482096|SUPERIORITY||Least squares mean difference|-0.11|||||TWO_SIDED|95.0|-0.5|0.29||||||||0.29|-0.50|
70986196|NCT02260193|141482096|SUPERIORITY||Least squares mean difference|0.23|||||TWO_SIDED|95.0|-0.16|0.62||||||||0.62|-0.16|
70986197|NCT02389946|141482118|NON_INFERIORITY|Non-inferiority of the 12-month TLF rate for the Orsiro stent vs. the Xience stent was assessed as the primary endpoint. The null hypothesis H0 was that the Orsiro stent would have a primary endpoint (12-month TLF) rate equal to or exceeding that of the Xience group by the non-inferiority margin or more. The alternative hypothesis HA was that the Orsiro stent would have a 12-month TLF rate less than the Xience group rate plus the non-inferiority margin of 3.85%.|Posterior Probability of non-inferioriry|100.0|||||TWO_SIDED|||||||||Bayesian calculation using a hierarchical model to incorporate data from previous BIOFLOW-II and BIOFLOW-IV trials.||||
70986198|NCT02389946|141482119|OTHER|||||||0.415|||||||Fisher Exact|||||||0.415
70986199|NCT01377467|141482128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.059|STANDARD_ERROR_OF_MEAN|0.967|<|0.001|TWO_SIDED|95.0|3.137|6.98|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.|We calculated that a sample size of 43 patients per group would provide a statistical power of 86% to detect a 4% difference in the percentage change of areal BMD at the total lumbar spine at 12 months, using a two-sided t-test with an α-level of 0.05 and assuming a mean ± SD change of 4 ± 6% in the denosumab group and 0 ± 6% in the control group. To account for a dropout rate of 5%, it was planned to randomize a total of 90 patients.||6.980|3.137|<0.001
70986200|NCT01377467|141482129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.895|STANDARD_ERROR_OF_MEAN|0.887||0.035|TWO_SIDED|95.0|0.132|3.659|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.|||3.659|0.132|0.035
70986201|NCT01377467|141482130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.059|STANDARD_ERROR_OF_MEAN|1.201||0.38|TWO_SIDED|95.0|-1.329|3.447|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.|||3.447|-1.329|0.380
70986202|NCT01377467|141482131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.567|STANDARD_ERROR_OF_MEAN|0.806|<|0.001|TWO_SIDED|95.0|2.975|6.178|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.|||6.178|2.975|<0.001
70986203|NCT01377467|141482132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.756|STANDARD_ERROR_OF_MEAN|0.662||0.009|TWO_SIDED|95.0|0.44|3.072|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.|||3.072|0.440|0.009
70986204|NCT01377467|141482133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.035|STANDARD_ERROR_OF_MEAN|1.085||0.064|TWO_SIDED|95.0|-0.122|4.193|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.|||4.193|-0.122|0.064
70986205|NCT01377467|141482134|SUPERIORITY_OR_OTHER||between-subjects effect|10.466|||<|0.001|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p=0.007. Time\*treatment interaction: p=0.002. The a priori threshold for statistical significance is \<0.05.|||||<0.001
70986206|NCT01377467|141482135|SUPERIORITY_OR_OTHER||between-subjects effect|275622.016|||<|0.001|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p\<0.001. Time\*treatment interaction: p=0.012. The a priori threshold for statistical significance is \<0.05.|||||<0.001
70986207|NCT01377467|141482136|SUPERIORITY_OR_OTHER||between-subjects effect|0.717||||0.014|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p\<0.001. Time\*treatment interaction: p\<0.001. The a priori threshold for statistical significance is \<0.05.|||||0.014
71098065|NCT00567112|141704488|SUPERIORITY_OR_OTHER||||||>|0.2||95.0|||||ANOVA|||OCT (fasted)/DFC (fasted)||||>0.200
70986208|NCT01377467|141482137|SUPERIORITY_OR_OTHER||between-subjects effect|0.707||||0.068|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p\<0.001. Time\*treatment interaction: p=0.047. The a priori threshold for statistical significance is \<0.05.|||||0.068
70986209|NCT01377467|141482138|SUPERIORITY_OR_OTHER||between-subjects effect|99952.126||||0.114|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p\<0.001. Time\*treatment interaction: p=0.047. The a priori threshold for statistical significance is \<0.05.|||||0.114
71098066|NCT00567112|141704489|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||OCT (after meal)/OCT (fasted)||||<0.001
71098067|NCT00567112|141704490|SUPERIORITY_OR_OTHER||||||>|0.2|||||||ANOVA|||OCT (after meal)/OCT (fasted)||||>0.200
71098068|NCT04595370|141704502|OTHER||F test statistics|1.07||||0.3645|||||||F-Test|||||||0.3645
71098069|NCT04595370|141704503|OTHER||Percent difference between treatment|-33.606||||0.1588|TWO_SIDED|95.0|-62.53|17.644|||Mixed Models Analysis|||||17.644|-62.530|0.1588
71098070|NCT04595370|141704503|OTHER||Percent difference between treatment|-11.826||||0.6846|TWO_SIDED|95.0|-52.195|62.634|||Mixed Models Analysis|||||62.634|-52.195|0.6846
71098071|NCT04595370|141704503|OTHER||Percent difference between treatment|-36.127||||0.1398|TWO_SIDED|95.0|-64.85|16.066|||Mixed Models Analysis|||||16.066|-64.850|0.1398
70986210|NCT01377467|141482139|SUPERIORITY_OR_OTHER||between-subjects effect|84.83||||0.578|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p\<0.001. Time\*treatment interaction: p=0.593. The a priori threshold for statistical significance is \<0.05.|||||0.578
71098072|NCT01125748|141704523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.3|||||TWO_SIDED|95.0|5.0|33.6||||||||33.6|5.0|
71098073|NCT02405962|141704525|SUPERIORITY||Adjusted Incidence Rate Ratio|0.2|||<|0.05|TWO_SIDED|95.0|0.08|0.53|||Mixed Models Analysis|||||0.53|0.08|<0.05
71098074|NCT01028391|141704540|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|4.0||||95.0|-0.76|-0.26|||||This is a difference in least squares means, based on an ANCOVA model with terms for treatment and baseline (i.e., Week 0 of the 24-week base study) HbA1c.|||-0.26|-0.76|
70986211|NCT01377467|141482140|SUPERIORITY_OR_OTHER||between-subjects effect|248.686||||0.607|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p\<0.001. Time\*treatment interaction: p=0.296. The a priori threshold for statistical significance is \<0.05.|||||0.607
70986212|NCT01377467|141482141|SUPERIORITY_OR_OTHER||z value|-2.342||||0.019|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.019
71098075|NCT01028391|141704541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.5|STANDARD_ERROR_OF_MEAN|4.0||||95.0|-16.3|-0.7|||||This is a difference in least squares means, based on an ANCOVA model with terms for treatment and baseline (i.e., Week 0 of the 24-week base study) FPG.|||-0.7|-16.3|
70986213|NCT01377467|141482142|SUPERIORITY_OR_OTHER||z value|-2.049||||0.042|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.042
70986214|NCT01377467|141482143|SUPERIORITY_OR_OTHER||z value|-0.937||||0.371|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.371
70986215|NCT01377467|141482144|SUPERIORITY_OR_OTHER||z value|-2.752||||0.005|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.005
70986216|NCT01377467|141482145|SUPERIORITY_OR_OTHER||z value|-2.166||||0.031|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.031
70986217|NCT01377467|141482146|SUPERIORITY_OR_OTHER||z value|-1.288||||0.212|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.212
70986218|NCT01377467|141482147|SUPERIORITY_OR_OTHER||z value|-1.64||||0.108|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.108
70986219|NCT01377467|141482148|SUPERIORITY_OR_OTHER||z value|-1.991||||0.048|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.048
70986220|NCT01354691|141482149|SUPERIORITY||||||<|0.67|||||||ANCOVA|||||||<0.67
70986221|NCT01354691|141482150|SUPERIORITY||||||<|0.21|||||||ANCOVA|||||||<0.21
70986222|NCT01354691|141482151|SUPERIORITY||||||<|0.78|||||||ANCOVA|||||||<0.78
70986223|NCT01354691|141482152|SUPERIORITY||||||=|0.83|||||||ANCOVA|||||||=0.83
70986224|NCT01354691|141482153|SUPERIORITY||||||=|0.77|||||||ANCOVA|||||||=.77
70986225|NCT00633139|141482154|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4013|TWO_SIDED||||||ANCOVA|||||||0.4013
70986226|NCT00633139|141482155|SUPERIORITY_OR_OTHER_LEGACY|||||||0.275|TWO_SIDED|95.0|||||ANCOVA|||||||0.2750
70986227|NCT00633139|141482156|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1363|TWO_SIDED|95.0|||||ANCOVA|||||||0.1363
70986228|NCT00410280|141482158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.44||||0.0947|TWO_SIDED|95.0|-14.04|1.15|||ANOVA|||Repeated measures analysis of variance (ANOVA) model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95 % confidence interval (CI) and p-value were derived from the model.||1.15|-14.04|0.0947
71098076|NCT01049828|141704557|OTHER|The analysis is based on a threshold-free cluster enhancement permutation technique.|||||<|0.01||||||all correlations were transformed into z scores using Fisher's transformation and a t test evaluated group differences.|Fisher Exact|The analysis is based on a threshold-free cluster enhancement permutation technique.||Null hypothesis: Fisher's transform z scores for a seed region were comparable between the control and non-bothered tinnitus groups.||||<0.01
71098077|NCT03572218|141704586|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.22|TWO_SIDED||||||Mixed Models Analysis|||||||0.22
71098078|NCT03572218|141704587|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.45|TWO_SIDED||||||Mixed Models Analysis|||||||0.45
70986229|NCT00410280|141482159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.24||||0.2673|TWO_SIDED|95.0|-11.84|3.35|||ANOVA|||Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||3.35|-11.84|0.2673
70986230|NCT00410280|141482160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.8||||0.0391|TWO_SIDED|95.0|-46.35|-1.24|||ANOVA|||Day 14: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||-1.24|-46.35|0.0391
70986231|NCT00410280|141482160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.17||||0.1326|TWO_SIDED|95.0|-39.72|5.39|||ANOVA|||Day 35: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||5.39|-39.72|0.1326
70986232|NCT00410280|141482161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.76||||0.0423|TWO_SIDED|95.0|-19.16|-0.35|||ANOVA|||Day 14: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||-0.35|-19.16|0.0423
70986233|NCT00410280|141482161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.06||||0.3902|TWO_SIDED|95.0|-13.46|5.35|||ANOVA|||Day 35: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||5.35|-13.46|0.3902
71098079|NCT03572218|141704588|SUPERIORITY||Mean Difference (Net)|-4.4|STANDARD_ERROR_OF_MEAN|1.9||0.03|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-Total||||0.03
71098080|NCT03572218|141704588|SUPERIORITY||Mean Difference (Net)|-2.8|STANDARD_ERROR_OF_MEAN|1.1||0.02|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-SD||||0.02
70986234|NCT00410280|141482162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.05||||0.0302|TWO_SIDED|95.0|-36.21|-1.9|||ANOVA|||Day 14: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||-1.90|-36.21|0.0302
70986235|NCT00410280|141482162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.19||||0.1289|TWO_SIDED|95.0|-30.34|3.97|||ANOVA|||Day 35: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||3.97|-30.34|0.1289
70986236|NCT00410280|141482163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.8469|TWO_SIDED|95.0|-0.79|0.96|||Mixed Models Analysis|||Screening: Mixed model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participants was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-values were derived from the model.||0.96|-0.79|0.8469
70986237|NCT00410280|141482163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9995|TWO_SIDED|95.0|-0.86|0.86|||Mixed Models Analysis|||Day 14: Mixed model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participants was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-values were derived from the model.||0.86|-0.86|0.9995
70986238|NCT00410280|141482163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.528|TWO_SIDED|95.0|-1.14|0.59|||Mixed Models Analysis|||Day 35: Mixed model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participants was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-values were derived from the model.||0.59|-1.14|0.5280
70986239|NCT01522651|141482179|OTHER|Pairwise Comparative analysis|Percentage Difference|-19.8|STANDARD_ERROR_OF_MEAN|25.7||0.493|TWO_SIDED|95.0|-57.5|51.5||An equal-slopes analysis of covariance (ANCOVA) model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||51.5|-57.5|0.493
70986240|NCT01522651|141482179|OTHER|Pairwise Comparative analysis|Percentage Difference|8.8|STANDARD_ERROR_OF_MEAN|32.9||0.78|TWO_SIDED|95.0|-40.2|98.2||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||98.2|-40.2|0.780
70986241|NCT01522651|141482179|OTHER|Pairwise Comparative analysis|Percentage Difference|-57.0|STANDARD_ERROR_OF_MEAN|13.4||0.008|TWO_SIDED|95.0|-76.8|-20.1||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||-20.1|-76.8|0.008
70986242|NCT01522651|141482179|OTHER|Pairwise Comparative analysis|Percentage Difference|-42.6|STANDARD_ERROR_OF_MEAN|17.5||0.072|TWO_SIDED|95.0|-68.7|5.2||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||5.2|-68.7|0.072
70986243|NCT01522651|141482179|OTHER|Pairwise Comparative analysis||||||0.315||||||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||||0.315
70986244|NCT01522651|141482179|OTHER|Pairwise Comparative analysis||||||0.049||||||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||||0.049
70986245|NCT01522651|141482179|OTHER|Pairwise Comparative analysis||||||0.275||||||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||||0.275
70986246|NCT01522651|141482179|OTHER|Pairwise Comparative analysis||||||0.002||||||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||||0.002
70986247|NCT01522651|141482179|OTHER|Pairwise Comparative analysis||||||0.028||||||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||||0.028
70986248|NCT01522651|141482179|OTHER|Pairwise Comparative analysis||||||0.334||||||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||||0.334
70986249|NCT02658656|141482182|SUPERIORITY||Risk Ratio (RR)|0.91||||0.798|TWO_SIDED|95.0|0.45|1.85|||Chi-squared|||||1.85|.45|0.798
70986250|NCT02658656|141482183|SUPERIORITY||Risk Ratio (RR)|0.97||||0.935|TWO_SIDED|95.0|0.44|2.15|||Chi-squared|||||2.15|0.44|0.935
71098081|NCT03572218|141704588|SUPERIORITY||Mean Difference (Net)|-1.6|STANDARD_ERROR_OF_MEAN|1.2||0.19|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-FNE||||0.19
71098082|NCT03572218|141704589|SUPERIORITY||Mean Difference (Net)|-3.5|STANDARD_ERROR_OF_MEAN|2.1||0.11|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-Total||||0.11
71098083|NCT03572218|141704589|SUPERIORITY||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|1.1||0.03|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-SD||||0.03
70986251|NCT02658656|141482184|SUPERIORITY||Risk Ratio (RR)|0.93||||0.829|TWO_SIDED|95.0|0.49|1.79|||Chi-squared|||||1.79|0.49|0.829
70986252|NCT02658656|141482185|SUPERIORITY||Risk Ratio (RR)|1.09||||0.809|TWO_SIDED|95.0|0.56|2.11|||Chi-squared|||||2.11|0.56|0.809
70986253|NCT02658656|141482186|SUPERIORITY||Risk Ratio (RR)|1.15||||0.717|TWO_SIDED|95.0|0.54|2.47|||Chi-squared|||||2.47|0.54|0.717
70986254|NCT02658656|141482187|SUPERIORITY||Risk Ratio (RR)|1.11||||0.738|TWO_SIDED|95.0|0.61|2.02|||Chi-squared|||||2.02|0.61|0.738
70986255|NCT01850563|141482215|OTHER||Hazard Ratio (HR)|0.87||||0.76|TWO_SIDED||||||Kaplan-Meier|||||||0.76
70986256|NCT01850563|141482217|OTHER||Hazard Ratio (HR)|0.82||||0.76|TWO_SIDED||||||Kaplan-Meier|||||||0.76
70986257|NCT03478878|141482249|SUPERIORITY||Mean Difference (Final Values)|1.83||||0.705|TWO_SIDED|95.0|-9.43|13.11||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the treatment completion visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the treatment completion visit (Month 2 for Cohort 1)."||13.11|-9.43|0.705
70986258|NCT03478878|141482249|SUPERIORITY||Mean Difference (Final Values)|1.8||||0.577|TWO_SIDED|95.0|-27.43|31.02||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the treatment completion visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the treatment completion visit (Month 1 for Cohort 2)."||31.02|-27.43|0.577
70986259|NCT03478878|141482250|SUPERIORITY||Mean Difference (Final Values)|1.87||||0.646|TWO_SIDED|95.0|-7.6|11.35||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the treatment completion visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the post-treatment follow-up visit (Month 3 for Cohort 1)."||11.35|-7.60|0.646
70986260|NCT03478878|141482250|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.405|TWO_SIDED|95.0|-19.3|23.9||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the treatment completion visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the post-treatment follow-up visit (Month 2 for Cohort 2)."||23.90|-19.30|0.405
70986261|NCT05057988|141482263|OTHER|paired T test|Mean Difference (Net)|1.04|STANDARD_DEVIATION|1.8|<|0.001|TWO_SIDED|95.0|0.53|1.55|||t-test, 2 sided|||||1.55|0.53|<.001
70986262|NCT05057988|141482264|OTHER|Paired T test|Mean Difference (Net)|0.98|STANDARD_DEVIATION|8.17||0.208|TWO_SIDED|95.0|-1.42|3.37|||t-test, 2 sided|||||3.37|-1.42|.208
70986263|NCT05057988|141482265|OTHER|Paired T test|Mean Difference (Net)|0.86|STANDARD_DEVIATION|1.2|<|0.001|TWO_SIDED|95.0|0.52|1.2|||t-test, 2 sided|||||1.20|0.52|<.001
70986264|NCT05057988|141482266|OTHER|Paired t test|Mean Difference (Net)|0.81|STANDARD_DEVIATION|5.65||0.328|TWO_SIDED|95.0|-0.84|2.47|||t-test, 1 sided|||||2.47|-.84|.328
70986265|NCT05057988|141482267|OTHER|Paired T test|Mean Difference (Final Values)|2.71|STANDARD_DEVIATION|4.95|<|0.001|TWO_SIDED|95.0|1.26|4.16|||t-test, 1 sided|||||4.16|1.26|<.001
70986266|NCT05057988|141482268|OTHER|Paired T test|Mean Difference (Final Values)|0.65|STANDARD_DEVIATION|6.38||0.486|TWO_SIDED|95.0|-1.22|2.53|||t-test, 1 sided|||||2.53|-1.22|.486
70986267|NCT05057988|141482269|OTHER|Paired T test|Mean Difference (Final Values)|-0.24|STANDARD_DEVIATION|7.57||0.832|TWO_SIDED|95.0|-2.46|1.99|||t-test, 2 sided|||||1.99|-2.46|.832
70986268|NCT05057988|141482270|OTHER|Paired T test|Mean Difference (Net)|-0.43|STANDARD_DEVIATION|3.06||0.34|TWO_SIDED|95.0|-1.33|0.47|||t-test, 2 sided|||||0.47|-1.33|.340
70986269|NCT05057988|141482272|SUPERIORITY||Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.31||0.37|TWO_SIDED|95.0|-0.34|0.89|||t-test, 2 sided|paired sample t test||paired sample t test||0.89|-0.34|0.370
70986270|NCT05057988|141482272|OTHER|Paired T test|Mean Difference (Net)|0.28|STANDARD_DEVIATION|2.09||0.37|TWO_SIDED|95.0|-0.34|0.89|||t-test, 2 sided|||||.89|-.34|.370
70986271|NCT00532883|141482369|SUPERIORITY_OR_OTHER|||||||0.93||95.0||||This is a global test comparing all four treatment arms.|Mixed Models Analysis|||F-test from a longitudinal mixed model (controlling for baseline measurement)testing the hypothesis of no difference in mean percent dense cells between the four treatment groups at Visit 6. The study was originally powered to detect a difference of 20%, but it was stopped early.||||0.93
70986272|NCT00076219|141482370|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09|STANDARD_ERROR_OF_MEAN|0.12||0.47|TWO_SIDED|95.0|0.86|1.4|||Regression, Logistic|||||1.40|0.86|0.47
70986273|NCT02795767|141482435|OTHER||ABR Ratio|0.01|||||TWO_SIDED|95.0|0.006|0.023|||||Emicizumab QW is the numerator and Prophylactic/Episodic Bypassing Agent is the denominator.|||0.023|0.006|
70986274|NCT02795767|141482436|OTHER||ABR Ratio|0.1|||||TWO_SIDED|95.0|0.051|0.21|||||Emicizumab QW is the numerator and Prophylactic/Episodic Bypassing Agent is the denominator.|||0.210|0.051|
71098084|NCT03572218|141704589|SUPERIORITY||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|1.3||0.53|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-FNE||||0.53
70986275|NCT02553915|141482465|OTHER|Comparisons were made for each biomarker within each arm pre and post 12 weeks of treatment.|||||<|0.1|||||||Kruskal-Wallis|||To evaluate whether a dose-response relationship exists between dose of EPA and decrease either in plasma IL-6 levels or in mitogen-stimulated PBMC TNF-α expression and secretion, when compared with placebo. \[Time Frame: 12 weeks\]. Comparisons were made within each arm pre and post 12 weeks of treatment.||||<0.10
70986276|NCT02553915|141482466|SUPERIORITY||||||<|0.1|||||||ANOVA|||"To evaluate:~1. whether EPA treatment produces a decrease in ratings of depression severity, when compared with placebo-treated subjects; and~2. whether the changes in IL-6 or mitogen- stimulated PBMC TNF-α expression mediate changes observed in ratings of depression.~\[Time Frame: 12 weeks\]"||||<0.1
70986277|NCT02553915|141482467|OTHER||||||<|0.01|||||||Kruskal-Wallis|||Change in IDS-C30 scores were compared pre and post 12 weeks of treatment with each intervention, within each arm.||||<0.01
70986278|NCT02553915|141482468|OTHER|Exploratory.|||||<|0.1|||||||Spearman Rank Order Correlation|||To evaluate whether EPA treatment produces decreases in mitogen-stimulated PBMC IL-6. \[Time Frame: 12 weeks\] Comparisons were made between pre and post treatment levels in each of the 4 treatment arms.||||<0.1
70986279|NCT02553915|141482469|OTHER|Exploratory|||||<|0.1|||||||Spearman Rank Order Correlation|||To evaluate whether EPA treatment produces decreases in the expression of inflammation pathway-related genes. \[Time Frame: 12 weeks\] (We evaluated gene expression of IL-6 and TNF-α.)||||<0.1
70986280|NCT03078608|141482504|SUPERIORITY||F statistic|0.0||||1|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||1.00
70986281|NCT03078608|141482505|SUPERIORITY||F statistic|2.58||||0.11|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.11
71098085|NCT03572218|141704590|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.12|TWO_SIDED||||||Mixed Models Analysis|||||||0.12
71098086|NCT03572218|141704591|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.09|TWO_SIDED||||||Mixed Models Analysis|||||||0.09
70986282|NCT03078608|141482506|SUPERIORITY||F statistic|0.07||||0.79|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.79
70986283|NCT03078608|141482507|SUPERIORITY||F statistic|1.17||||0.29|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.29
70986284|NCT03078608|141482508|SUPERIORITY||F statistic|0.18||||0.67|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.67
70986285|NCT03078608|141482509|SUPERIORITY||F statistic|1.41||||0.24|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.24
70986286|NCT03078608|141482510|SUPERIORITY||F statistic|1.36||||0.25|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.25
70986287|NCT03078608|141482511|SUPERIORITY||F statistic|0.53||||0.47|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.47
71037787|NCT00112437|141582572|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.68||||0.161|TWO_SIDED|95.0|-20.58|17.23||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 12 months.||17.23|-20.58|0.161
71037788|NCT00112437|141582572|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.58|||||TWO_SIDED|95.0|-20.99|17.82||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 12 months.||17.82|-20.99|
71037789|NCT00112437|141582572|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|46.9|||||TWO_SIDED|95.0|22.35|71.44||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 12 months.||71.44|22.35|
71037790|NCT00112437|141582573|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|4.1|||<=|0.001|TWO_SIDED|95.0|2.77|5.42||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 24 months.||5.42|2.77|<=0.001
71037791|NCT00112437|141582573|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|3.48|||<=|0.001|TWO_SIDED|95.0|2.2|4.77||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 24 months.||4.77|2.20|<=0.001
71037792|NCT00112437|141582573|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.75|||<=|0.001|TWO_SIDED|95.0|1.43|4.07||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 24 months.||4.07|1.43|<=0.001
71037793|NCT00112437|141582573|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.51||||0.536|TWO_SIDED|95.0|-1.84|0.83||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 24 months.||0.83|-1.84|0.536
71098087|NCT03572218|141704592|SUPERIORITY||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|2.9||0.84|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Impact of Weight on Quality of Life Questionnaire-Lite for Total score||||0.84
71098088|NCT03572218|141704592|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|4.0||0.82|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Physical Function Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.82
71098089|NCT03572218|141704592|SUPERIORITY||Mean Difference (Net)|3.7|STANDARD_ERROR_OF_MEAN|4.3||0.39|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Self Esteem Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.39
71098090|NCT03572218|141704592|SUPERIORITY||Mean Difference (Net)|-4.0|STANDARD_ERROR_OF_MEAN|5.0||0.42|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Sexual Life Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.42
71098091|NCT03572218|141704592|SUPERIORITY||Mean Difference (Net)|-2.0|STANDARD_ERROR_OF_MEAN|4.3||0.64|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Work Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.64
71098092|NCT03572218|141704592|SUPERIORITY||Mean Difference (Net)|-2.0|STANDARD_ERROR_OF_MEAN|3.6||0.59|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Public Distress Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.59
70986288|NCT03078608|141482512|SUPERIORITY||F statistic|1.54||||0.23|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.23
70986289|NCT03078608|141482513|SUPERIORITY||F statistic|0.8||||0.39|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.39
70986290|NCT00784784|141482567|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.23||||0.25|TWO_SIDED|95.0|0.01|4.8|||Fisher Exact|||That in a year with mismatch between influenza vaccine antigen and infecting H3N2 strain, seasonal (10-13 weeks) antiviral prophylaxis in adults will provide better protection from symptomatic influenza infection than trivalent inactivated split virus influenza vaccine.||4.8|0.01|0.25
70986291|NCT01729598|141482569|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
70986292|NCT01729598|141482570|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||||||0.19
70986293|NCT01729598|141482571|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
70986294|NCT01729598|141482572|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||||||0.31
70986295|NCT01905397|141482573|SUPERIORITY||Difference in proportions|0.05||||0.27|ONE_SIDED||||||t-test, 1 sided|||||||0.27
70986296|NCT02099799|141482576|SUPERIORITY||Mean Difference (Final Values)|-12.0||||0.189|TWO_SIDED||||||Mixed Models Analysis|||||||0.189
70986297|NCT02099799|141482577|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.572|TWO_SIDED||||||Mixed Models Analysis|||||||0.572
70986298|NCT02099799|141482578|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.799|TWO_SIDED||||||Mixed Models Analysis|||||||0.799
70986299|NCT02099799|141482579|SUPERIORITY||Mean Difference (Final Values)|1312.0|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
70986300|NCT02099799|141482580|SUPERIORITY|||||||0.2265|||||||t-test, 2 sided|||||||0.2265
70986301|NCT02099799|141482581|SUPERIORITY|||||||0.8897|||||||t-test, 2 sided|||||||0.8897
70986302|NCT00772967|141482583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.611||||0.089||90.0|-1.36|0.14||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||0.14|-1.36|0.089
70986303|NCT00772967|141482583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.804||||0.043||90.0|-1.57|-0.04||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||-0.04|-1.57|0.043
70986304|NCT00772967|141482584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.518||||0.048||90.0|-1.03|-0.01||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||-0.01|-1.03|0.048
70986305|NCT00772967|141482584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.001||90.0|-1.54|-0.53||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||-0.53|-1.54|0.001
70986306|NCT00772967|141482585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.658||||0.052||90.0|-1.32|0.01||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||0.01|-1.32|0.052
70986307|NCT00772967|141482585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15||||0.003||90.0|-1.81|-0.49||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||-0.49|-1.81|0.003
70986308|NCT00772967|141482586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.875||||0.019||90.0|-1.56|-0.19||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||-0.19|-1.56|0.019
70986309|NCT00772967|141482586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07||||0.007||90.0|-1.77|-0.37||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||-0.37|-1.77|0.007
70986310|NCT04172831|141482589|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.16||0.01|TWO_SIDED|95.0|-0.7|-0.1|||Mixed Model Repeated Measures||Treatment Difference = TNX-102 - Placebo|||-0.1|-0.7|0.010
70986311|NCT04172831|141482590|SUPERIORITY||Odds Ratio (OR)|1.44||||0.058|TWO_SIDED|95.0|0.99|2.1|||Regression, Logistic|||||2.10|0.99|0.058
70986312|NCT04172831|141482591|SUPERIORITY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|1.6||0.007|TWO_SIDED|95.0|-7.5|-1.2|||Mixed Model Repeated Measures||Treatment Difference = TNX-102 - Placebo|||-1.2|-7.5|0.007
70986313|NCT04172831|141482592|SUPERIORITY||LS Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|1.69||0.009|TWO_SIDED|95.0|-7.7|-1.1|||Mixed Model Repeated Measures||Treatment Difference = TNX-102 - Placebo|||-1.1|-7.7|0.009
70986314|NCT04172831|141482593|SUPERIORITY||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.82|<|0.001|TWO_SIDED|95.0|-4.5|-1.3|||Mixed Model Repeated Measures||Treatment Difference = TNX-102 - Placebo|||-1.3|-4.5|<0.001
70986315|NCT04172831|141482594|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.76||0.018|TWO_SIDED|95.0|-3.3|-0.3|||Mixed Model Repeated Measures||Treatment Difference = TNX-102 - Placebo|||-0.3|-3.3|0.018
70986316|NCT04172831|141482595|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-0.9|-0.3|||Mixed Model Repeated Measures||Treatment Difference = TNX-102 - Placebo|||-0.3|-0.9|<0.001
70986317|NCT01041573|141482596|SUPERIORITY_OR_OTHER_LEGACY|||||||0.641|||||||Fisher Exact|||||||0.641
70986318|NCT01041573|141482596|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
70986319|NCT01052012|141482603|SUPERIORITY||LS Mean Difference (Final Values)|-0.89|STANDARD_ERROR_OF_MEAN|0.597||0.1473|TWO_SIDED|95.0|-2.11|0.33|||ANCOVA|With pooled site and treatment group as factors and incision length as a covariate.||||0.33|-2.11|0.1473
70986320|NCT01052012|141482603|SUPERIORITY||LS Mean Difference (Final Values)|-1.06|STANDARD_ERROR_OF_MEAN|0.547||0.0601|TWO_SIDED|95.0|-2.16|0.05|||ANCOVA|with pooled site and treatment group as factors and incision length as a covariate.||||0.05|-2.16|0.0601
70986321|NCT01052012|141482603|SUPERIORITY||LS Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.233||0.1483|TWO_SIDED|95.0|-0.8|0.12|||ANCOVA|with pooled site and treatment group as factors and incision length as a covariate.||||0.12|-0.80|0.1483
70986322|NCT01052012|141482604|SUPERIORITY||Median Difference (Hodge-Lehmann)|-1.0||||0.9901|TWO_SIDED|95.0|-54.5|52.0|||Wilcoxon (Mann-Whitney)|||||52.0|-54.5|0.9901
70986323|NCT01052012|141482604|SUPERIORITY||Median Difference (Hodge-Lehmann)|-5.0||||0.201|TWO_SIDED|95.0|-14.0|3.4|||Wilcoxon Rank-Sum|||||3.4|-14.0|0.2010
70986324|NCT01052012|141482604|SUPERIORITY||Median Difference (Hodge-Lehmann)|-3.0||||0.5897|TWO_SIDED|95.0|-15.0|8.0|||Wilcoxon Rank-Sum|||||8.0|-15.0|0.5897
70986325|NCT00492401|141482626|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Expression levels of miR-29b in pre treatment marrow samples from responding or non responding patients were compared using Wilcoxon rank sum tests||||.02
71037794|NCT00112437|141582574|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|4.69|||<=|0.001|TWO_SIDED|95.0|3.25|6.12||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 24 months.||6.12|3.25|<=0.001
71037795|NCT00112437|141582574|SUPERIORITY_OR_OTHER||Difference in Least Square Means|3.57|||<=|0.001|TWO_SIDED|95.0|2.18|4.97||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 24 months.||4.97|2.18|<=0.001
71037796|NCT00112437|141582574|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.82|||<=|0.001|TWO_SIDED|95.0|1.39|4.25||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 24 months.||4.25|1.39|<=0.001
71037797|NCT00112437|141582574|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.41||||0.585|TWO_SIDED|95.0|-1.85|1.04||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 24 months.||1.04|-1.85|0.585
71037798|NCT00112437|141582575|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|5.09|||<=|0.001|TWO_SIDED|95.0|3.18|7.01||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 24 months.||7.01|3.18|<=0.001
71037799|NCT00112437|141582575|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|4.56|||<=|0.001|TWO_SIDED|95.0|2.7|6.42||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 24 months.||6.42|2.70|<=0.001
71037800|NCT00112437|141582575|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|4.43|||<=|0.001|TWO_SIDED|95.0|2.52|6.33||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 24 months.||6.33|2.52|<=0.001
71098093|NCT03572218|141704593|SUPERIORITY||Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|3.0||0.58|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Impact of Weight on Quality of Life Questionnaire-Lite for Total score||||0.58
71098094|NCT03572218|141704593|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|4.0||0.89|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Physical Function Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.89
71098095|NCT03572218|141704593|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|4.7||0.9|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Self Esteem Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.90
71098096|NCT03572218|141704593|SUPERIORITY||Mean Difference (Net)|-7.1|STANDARD_ERROR_OF_MEAN|5.0||0.16|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Sexual Life Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.16
71098097|NCT03572218|141704593|SUPERIORITY||Mean Difference (Net)|1.8|STANDARD_ERROR_OF_MEAN|4.3||0.68|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Work Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.68
71098098|NCT03572218|141704593|SUPERIORITY||Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|3.6||0.72|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Public Distress Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.72
71037801|NCT00112437|141582575|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.04||||0.981|TWO_SIDED|95.0|-1.97|1.89||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 24 months.||1.89|-1.97|0.981
71037802|NCT00112437|141582576|SUPERIORITY_OR_OTHER||Difference in Least square means|1.73|||<=|0.001||95.0|0.46|3.01||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Total Body BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Total Body BMD compared to placebo over 24 months.||3.01|0.46|<=0.001
71037803|NCT00112437|141582576|SUPERIORITY_OR_OTHER||Difference in Least square means|1.11||||0.028||95.0|-0.12|2.34||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Total Body BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Total Body BMD compared to placebo over 24 months.||2.34|-0.12|0.028
71037804|NCT00112437|141582576|SUPERIORITY_OR_OTHER||Difference in Least square means|0.2||||0.804||95.0|-1.1|1.49||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Total Body BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Total Body BMD compared to placebo over 24 months.||1.49|-1.10|0.804
71037805|NCT00112437|141582576|SUPERIORITY_OR_OTHER||Difference in Least square means|-1.15|||||TWO_SIDED|95.0|-2.46|0.15||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Total Body BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Total Body BMD compared to placebo over 24 months.||0.15|-2.46|
71098099|NCT03572218|141704594|SUPERIORITY||Mean Difference (Net)|-3.0|STANDARD_ERROR_OF_MEAN|1.7||0.08|TWO_SIDED||||||Mixed Models Analysis|||||||0.08
71098100|NCT03572218|141704595|SUPERIORITY||Mean Difference (Net)|-2.9|STANDARD_ERROR_OF_MEAN|1.7||0.1|TWO_SIDED||||||Mixed Models Analysis|||||||0.10
71098101|NCT03572218|141704596|SUPERIORITY||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|1.1||0.4|TWO_SIDED||||||Mixed Models Analysis|||||||0.40
71098102|NCT03572218|141704597|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|1.1||0.98|TWO_SIDED||||||Mixed Models Analysis|||||||0.98
71098103|NCT03572218|141704598|SUPERIORITY||Mean Difference (Net)|9.7|STANDARD_ERROR_OF_MEAN|6.5||0.14|TWO_SIDED||||||Mixed Models Analysis|||||||0.14
71098104|NCT03572218|141704599|SUPERIORITY||Mean Difference (Net)|12.1|STANDARD_ERROR_OF_MEAN|6.5||0.06|TWO_SIDED||||||Mixed Models Analysis|||||||0.06
71098105|NCT03572218|141704600|SUPERIORITY||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|4.4||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||0.80
71098106|NCT03572218|141704601|SUPERIORITY||Mean Difference (Net)|3.1|STANDARD_ERROR_OF_MEAN|4.4||0.49|TWO_SIDED||||||Mixed Models Analysis|||||||0.49
71098107|NCT03572218|141704602|SUPERIORITY||Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|1.4||0.31|TWO_SIDED||||||Mixed Models Analysis|||||||0.31
71098108|NCT03572218|141704603|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|1.3||0.54|TWO_SIDED||||||Mixed Models Analysis|||||||0.54
71098109|NCT03572218|141704604|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|2.2||0.94|TWO_SIDED||||||Mixed Models Analysis|||Systolic Blood Pressure||||0.94
71098110|NCT03572218|141704604|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|1.6||0.64|TWO_SIDED||||||Mixed Models Analysis|||Diastolic Blood Pressure||||0.64
71098111|NCT03572218|141704605|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.58|TWO_SIDED||||||Mixed Models Analysis|||Full Scale||||0.58
71098112|NCT03572218|141704605|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.49|TWO_SIDED||||||Mixed Models Analysis|||Negative Affect||||0.49
71098113|NCT03572218|141704605|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.96|TWO_SIDED||||||Mixed Models Analysis|||Maladaptive Eating||||0.96
71098114|NCT03572218|141704605|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.71|TWO_SIDED||||||Mixed Models Analysis|||Healthy Lifestyle||||0.71
71098115|NCT03572218|141704605|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.41|TWO_SIDED||||||Mixed Models Analysis|||Exercise Avoidance||||0.41
71098116|NCT03572218|141704606|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.61|TWO_SIDED||||||Mixed Models Analysis|||Full Scale||||0.61
71098117|NCT03572218|141704606|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.73|TWO_SIDED||||||Mixed Models Analysis|||Negative Affect||||0.73
71037806|NCT00112437|141582577|SUPERIORITY_OR_OTHER||Difference in Least square means|2.9|||<=|0.001|TWO_SIDED|95.0|1.34|4.46||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Distal Forearm BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Distal Forearm BMD compared to placebo over 24 months.||4.46|1.34|<=0.001
71037807|NCT00112437|141582577|SUPERIORITY_OR_OTHER||Difference in Least square means|2.09|||<=|0.001||95.0|0.59|3.6||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Distal Forearm BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Distal Forearm BMD compared to placebo over 24 months.||3.60|0.59|<=0.001
71037808|NCT00112437|141582577|SUPERIORITY_OR_OTHER||Difference in Least square means|1.53||||0.094||95.0|-0.01|3.07||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Distal Forearm BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Distal Forearm BMD compared to placebo over 24 months.||3.07|-0.01|0.094
71037809|NCT00112437|141582577|SUPERIORITY_OR_OTHER||Difference in Least square means|-2.95||||||95.0|-4.5|-1.4||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Distal Forearm BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Distal Forearm BMD compared to placebo over 24 months.||-1.40|-4.50|
71037810|NCT00112437|141582578|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-47.21|||<=|0.001||95.0|-64.51|-29.9||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 24 months.||-29.90|-64.51|<=0.001
71037811|NCT00112437|141582578|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-33.67|||<=|0.001||95.0|-51.44|-15.91||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 24 months.||-15.91|-51.44|<=0.001
71098118|NCT03572218|141704606|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.94|TWO_SIDED||||||Mixed Models Analysis|||Maladaptive Eating||||0.94
71098119|NCT03572218|141704606|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.47|TWO_SIDED||||||Mixed Models Analysis|||Healthy Lifestyle||||0.47
71098120|NCT03572218|141704606|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.99|TWO_SIDED||||||Mixed Models Analysis|||Exercise Avoidance||||0.99
71098121|NCT03572218|141704607|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.13
71098122|NCT03572218|141704608|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.13
71098123|NCT03572218|141704609|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.53|TWO_SIDED||||||Mixed Models Analysis|||||||0.53
71098124|NCT03572218|141704610|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.24|TWO_SIDED||||||Mixed Models Analysis|||||||0.24
71098125|NCT03572218|141704611|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.83|TWO_SIDED||||||Mixed Models Analysis|||Global||||0.83
71098126|NCT03572218|141704611|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.69|TWO_SIDED||||||Mixed Models Analysis|||Eating Restraint||||0.69
71098127|NCT03572218|141704611|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3|TWO_SIDED||||||Mixed Models Analysis|||Eating Concern||||0.30
71098128|NCT03572218|141704611|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.99|TWO_SIDED||||||Mixed Models Analysis|||Weight Concern||||0.99
71098129|NCT03572218|141704611|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.36|TWO_SIDED||||||Mixed Models Analysis|||Shape Concern||||0.36
71098130|NCT03572218|141704612|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3|TWO_SIDED||||||Mixed Models Analysis|||Global||||0.30
71098131|NCT03572218|141704612|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.69|TWO_SIDED||||||Mixed Models Analysis|||Eating Restraint||||0.69
71098132|NCT03572218|141704612|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7|TWO_SIDED||||||Mixed Models Analysis|||Eating Concern||||0.70
70986326|NCT00492401|141482626|SUPERIORITY_OR_OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Expression levels of DNMT3a in pre treatment marrow samples from responding or non responding patients were compared using Wilcoxon rank sum tests||||.06
70986327|NCT01000064|141482687|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.053
70986328|NCT01000064|141482688|SUPERIORITY_OR_OTHER|||||||0.052|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.052
70986329|NCT01000064|141482689|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED||||||t-test, 2 sided|||||||0.047
70986330|NCT01000064|141482690|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED||||||t-test, 2 sided|||||||0.047
70986331|NCT01000064|141482691|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|||||||0.003
70986332|NCT01000064|141482692|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||0.040
70986333|NCT01000064|141482693|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED||||||t-test, 2 sided|||||||0.047
70986334|NCT00798967|141482704|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Cochran-Mantel-Haenszel (CMH) test adjusted for the randomization stratification variable (\<= 6 or \> 6 L/week of PN at baseline)|Cochran-Mantel-Haenszel|||||||0.002
70986335|NCT00798967|141482705|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||Last Dosing Visit||||< 0.001
70986336|NCT03141307|141482713|EQUIVALENCE|95% margin|||||<|0.001||||||a priori threshold for statistical significance set for p \< .05|t-test, 2 sided|||||||<.001
70986337|NCT03141307|141482714|EQUIVALENCE|95% margin|||||<|0.05||||||a priori threshold for statistical significance set for p \< .05|t-test, 2 sided|||||||<.05
70986338|NCT03141307|141482715|EQUIVALENCE|95% margin|||||=|0.502||||||a priori threshold for statistical significance set for p \< .05|t-test, 2 sided|||||||=.502
70986339|NCT03141307|141482716|EQUIVALENCE|95% margin|||||=|0.071||||||a priori threshold for statistical significance set for p \< .05|t-test, 2 sided|||||||=.071
70986340|NCT03141307|141482717|EQUIVALENCE|95% margin|||||=|0.124||||||a prior threshold for statistical significance set for p \< .05.|t-test, 2 sided|||||||=.124
70986341|NCT03141307|141482718|EQUIVALENCE|95% margin|||||<|0.05||||||a priori threshold for statistical significance set for p \< .05|t-test, 2 sided|||||||<.05
70986342|NCT02160977|141482719|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70986343|NCT02160977|141482720|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70986344|NCT02160977|141482721|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70986345|NCT00408421|141482749|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for treatment effect at last visit. Effects evaluated based on 2-sided significance level=0.05. Model: treatment, NSAID use, investigator, week, treatment-by-week interaction, baseline score and baseline-by-week interaction.|Mixed-Effects Model Repeated Measures|No adjustments for multiple comparisons were made.||Null hypothesis: the difference in 24-hour average pain score between duloxetine and placebo treatment groups at last visit of treatment phase is zero. This study will have at least 80% power to detect a treatment group difference of 1.0 point in the baseline-to-endpoint mean change on the weekly mean of 24-hour average pain severity between duloxetine and placebo treatment groups based on Baseline Observation Carried Forward (BOCF).||||<0.001
70986346|NCT00408421|141482750|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53||||0.001||95.0|-0.84|-0.21||Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made.|ANCOVA|||An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), PGI severity at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean outcome measure at endpoint.||-0.21|-0.84|0.001
71098133|NCT03572218|141704612|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.26|TWO_SIDED||||||Mixed Models Analysis|||Weight Concern||||0.26
70986347|NCT00408421|141482751|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.41||||0.003||95.0|-2.33|-0.48||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-Baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.48|-2.33|0.003
70986348|NCT00408421|141482752|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.65||||0.004||95.0|-1.09|-0.22||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-Baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.22|-1.09|0.004
70986349|NCT00408421|141482753|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.18||||0.001||95.0|-8.33|-2.03||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-Baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-2.03|-8.33|0.001
70986350|NCT00408421|141482754|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.42||||0.004||95.0|-10.72|-2.11||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-Baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-2.11|-10.72|0.004
71037812|NCT00112437|141582578|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-35.94|||<=|0.001||95.0|-54.15|-17.74||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 24 months.||-17.74|-54.15|<=0.001
71037813|NCT00112437|141582578|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|17.51||||0.101|TWO_SIDED|95.0|-6.78|41.8||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 24 months.||41.80|-6.78|0.101
71037814|NCT00112437|141582579|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-63.34|||<=|0.001||95.0|-88.32|-38.36||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 24 months.||-38.36|-88.32|<=0.001
71037815|NCT00112437|141582579|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-39.29|||<=|0.001|TWO_SIDED|95.0|-65.4|-13.18||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 24 months.||-13.18|-65.40|<=0.001
71037816|NCT00112437|141582579|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-23.98||||0.124|TWO_SIDED|95.0|-53.04|5.09||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 24 months.||5.09|-53.04|0.124
71098134|NCT03572218|141704612|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.18|TWO_SIDED||||||Mixed Models Analysis|||Shape Concern||||0.18
71098135|NCT03572218|141704613|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|1.0||0.69|TWO_SIDED||||||Mixed Models Analysis|||Dietary Restraint||||0.69
71098136|NCT03572218|141704613|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|0.8||0.28|TWO_SIDED||||||Mixed Models Analysis|||Disinhibition||||0.28
71098137|NCT03572218|141704613|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.8||0.02|TWO_SIDED||||||Mixed Models Analysis|||Hunger||||0.02
71098138|NCT03572218|141704614|SUPERIORITY||Mean Difference (Net)|1.2|STANDARD_ERROR_OF_MEAN|1.1||0.29|TWO_SIDED||||||Mixed Models Analysis|||Dietary Restraint||||0.29
71098139|NCT03572218|141704614|SUPERIORITY||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|0.8||0.34|TWO_SIDED||||||Mixed Models Analysis|||Disinhibition||||0.34
71098140|NCT03572218|141704614|SUPERIORITY||Mean Difference (Net)|-2.5|STANDARD_ERROR_OF_MEAN|0.8||0.001|TWO_SIDED||||||Mixed Models Analysis|||Hunger||||0.001
71098141|NCT03572218|141704615|SUPERIORITY||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|1.1||0.32|TWO_SIDED||||||Mixed Models Analysis|||||||0.32
71098142|NCT03572218|141704616|SUPERIORITY||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|1.2||0.16|TWO_SIDED||||||Mixed Models Analysis|||||||0.16
71098143|NCT03572218|141704617|SUPERIORITY||Mean Difference (Net)|2.6|STANDARD_ERROR_OF_MEAN|4.8||0.59|TWO_SIDED||||||Mixed Models Analysis|||||||0.59
71098144|NCT03572218|141704618|SUPERIORITY||Mean Difference (Net)|-10.2|STANDARD_ERROR_OF_MEAN|13.1||0.44|TWO_SIDED||||||Mixed Models Analysis|||||||0.44
71098145|NCT03572218|141704619|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.46|TWO_SIDED||||||Mixed Models Analysis|||Self-Reported Weighing||||0.46
71098146|NCT03572218|141704619|SUPERIORITY||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|0.4||0.12|TWO_SIDED||||||Mixed Models Analysis|||Track Food/Drink||||0.12
71098147|NCT03572218|141704619|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.4||0.42|TWO_SIDED||||||Mixed Models Analysis|||Track Calories||||0.42
71098148|NCT03572218|141704619|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|0.4||0.03|TWO_SIDED||||||Mixed Models Analysis|||Track Activity||||0.03
71098149|NCT03572218|141704620|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.3||0.23|TWO_SIDED||||||Mixed Models Analysis|||Self-Reported Weighing||||0.23
70986351|NCT00408421|141482755|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.83||||0.005||95.0|-1.4|-0.25||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-Baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.25|-1.40|0.005
70986352|NCT00408421|141482756|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for treatment effect at last visit. Effects evaluated based on 2-sided significance level=0.05. Model: treatment, NSAID use, investigator, week, treatment-by-week interaction, baseline score and baseline-by-week interaction.|Mixed-Effects Model Repeated Measures|No adjustments for multiple comparisons were made.||||||<0.001
70986353|NCT00408421|141482757|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.87||||0.039||95.0|-1.69|-0.05||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.05|-1.69|0.039
70986354|NCT00408421|141482758|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35||||0.001||95.0|-0.56|-0.14||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.14|-0.56|0.001
70986355|NCT00408421|141482759|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.06|||<|0.001||95.0|-1.66|-0.46||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.46|-1.66|<0.001
70986356|NCT00408421|141482760|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.76||||0.004||95.0|-1.28|-0.24||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.24|-1.28|0.004
70986357|NCT00408421|141482761|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.97|||<|0.001||95.0|-1.52|-0.42||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.42|-1.52|<0.001
70986358|NCT00408421|141482762|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.91||||0.003||95.0|-1.5|-0.32||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.32|-1.50|0.003
70986359|NCT00408421|141482763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.71||||0.019||95.0|-1.3|-0.12||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.12|-1.30|0.019
71098150|NCT03572218|141704620|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.4||0.9|TWO_SIDED||||||Mixed Models Analysis|||Track Food/Drink||||0.90
71098151|NCT03572218|141704620|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.5||0.36|TWO_SIDED||||||Mixed Models Analysis|||Track Calories||||0.36
71098152|NCT03572218|141704620|SUPERIORITY||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|0.4||0.29|TWO_SIDED||||||Mixed Models Analysis|||Track Activity||||0.29
71098153|NCT03572218|141704621|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.25|TWO_SIDED||||||Mixed Models Analysis|||||||0.25
71098154|NCT03572218|141704622|SUPERIORITY||Mean Difference (Net)|-2.5|STANDARD_ERROR_OF_MEAN|2.2||0.27|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-Total||||0.27
71098155|NCT03572218|141704622|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|1.2||0.13|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-SD||||0.13
71037817|NCT00112437|141582579|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|22.18|||||TWO_SIDED|95.0|-12.38|56.73|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 24 months.||56.73|-12.38|
71037818|NCT00112437|141582580|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-16.71||||0.015||95.0|-36.03|2.61||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 24 months. The secondary hypothesis states that MK0822 will decrease biochemical indices of bone resorption (u-DPyr) over 24 months.||2.61|-36.03|0.015
71037819|NCT00112437|141582580|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-8.51||||0.246||95.0|-27.31|10.29||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 24 months. The secondary hypothesis states that MK0822 will decrease biochemical indices of bone resorption (u-DPyr) over 24 months.||10.29|-27.31|0.246
71037820|NCT00112437|141582580|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-1.79||||||95.0|-22.66|19.08|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 24 months. The secondary hypothesis states that MK0822 will decrease biochemical indices of bone resorption (u-DPyr) over 24 months.||19.08|-22.66|
71037821|NCT00112437|141582580|SUPERIORITY_OR_OTHER||Difference in Least Square Means|21.74||||||95.0|-1.32|44.81|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 24 months. The secondary hypothesis states that MK0822 will decrease biochemical indices of bone resorption (u-DPyr) over 24 months.||44.81|-1.32|
71098156|NCT03572218|141704622|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|1.4||0.65|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-FNE||||0.65
71098157|NCT03572218|141704623|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.21|TWO_SIDED||||||Mixed Models Analysis|||||||0.21
71098158|NCT03572218|141704624|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|1.2||0.7|TWO_SIDED||||||Mixed Models Analysis|||||||0.7
71098159|NCT03572218|141704625|SUPERIORITY||Mean Difference (Net)|-2.3|STANDARD_ERROR_OF_MEAN|1.8||0.2|TWO_SIDED||||||Mixed Models Analysis|||||||0.2
71098160|NCT03572218|141704626|SUPERIORITY||Mean Difference (Net)|3.7|STANDARD_ERROR_OF_MEAN|6.9||0.59|TWO_SIDED||||||Mixed Models Analysis|||||||0.59
71098161|NCT03572218|141704627|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|3.5||0.81|TWO_SIDED||||||Mixed Models Analysis|||Total||||0.81
71098162|NCT03572218|141704627|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|4.4||0.86|TWO_SIDED||||||Mixed Models Analysis|||Physical Function||||0.86
71098163|NCT03572218|141704627|SUPERIORITY||Mean Difference (Net)|1.2|STANDARD_ERROR_OF_MEAN|7.0||0.87|TWO_SIDED||||||Mixed Models Analysis|||Self Esteem||||0.87
71098164|NCT03572218|141704627|SUPERIORITY||Mean Difference (Net)|1.8|STANDARD_ERROR_OF_MEAN|5.2||0.73|TWO_SIDED||||||Mixed Models Analysis|||Sexual Life||||0.73
71098165|NCT03572218|141704627|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|4.4||0.95|TWO_SIDED||||||Mixed Models Analysis|||Work||||0.95
71098166|NCT03572218|141704627|SUPERIORITY||Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|3.8||0.19|TWO_SIDED||||||Mixed Models Analysis|||Public Distress||||0.19
71098167|NCT03572218|141704628|SUPERIORITY||Mean Difference (Net)|7.3|STANDARD_ERROR_OF_MEAN|4.9||0.14|TWO_SIDED||||||Mixed Models Analysis|||||||0.14
71098168|NCT03572218|141704629|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|1.5||0.53|TWO_SIDED||||||Mixed Models Analysis|||||||0.53
71098169|NCT03572218|141704630|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|1.5||0.99|TWO_SIDED||||||Mixed Models Analysis|||||||0.99
71098170|NCT03572218|141704631|SUPERIORITY||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|3.6||0.71|TWO_SIDED||||||Mixed Models Analysis|||Systolic Blood Pressure||||0.71
71098171|NCT03572218|141704631|SUPERIORITY||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|1.9||0.72|TWO_SIDED||||||Mixed Models Analysis|||Diastolic Blood Pressure||||0.72
71098172|NCT03572218|141704632|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.07|TWO_SIDED||||||Mixed Models Analysis|||||||0.07
71098173|NCT03572218|141704633|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.52|TWO_SIDED||||||Mixed Models Analysis|||Full Scale||||0.52
71098174|NCT03572218|141704633|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.02|TWO_SIDED||||||Mixed Models Analysis|||Negative Affect||||0.02
71098175|NCT03572218|141704633|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.63|TWO_SIDED||||||Mixed Models Analysis|||Maladaptive Eating||||0.63
71098176|NCT03572218|141704633|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.4||0.74|TWO_SIDED||||||Mixed Models Analysis|||Exercise Avoidance||||0.74
71098177|NCT03572218|141704633|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.49|TWO_SIDED||||||Mixed Models Analysis|||Healthy Lifestyle||||0.49
71098178|NCT03572218|141704634|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.33|TWO_SIDED||||||Mixed Models Analysis|||||||0.33
71098179|NCT03572218|141704635|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|1.2||0.11|TWO_SIDED||||||Mixed Models Analysis|||||||0.11
71098180|NCT03572218|141704636|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.35|TWO_SIDED||||||Mixed Models Analysis|||Global||||0.35
70986360|NCT00408421|141482764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.164||95.0|-0.97|0.17||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.17|-0.97|0.164
70986361|NCT00408421|141482765|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.63||||0.049||95.0|-1.25|0.0||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.00|-1.25|0.049
70986362|NCT00408421|141482766|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51||||0.093||95.0|-1.1|0.08||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.08|-1.10|0.093
71008811|NCT02055976|141525258|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.30542|STANDARD_ERROR_OF_MEAN|0.0323|<|0.001|TWO_SIDED|95.0|-0.3696|-0.24124|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.24124|-0.36960|<0.001
71098181|NCT03572218|141704636|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.4||0.46|TWO_SIDED||||||Mixed Models Analysis|||Eating Restraint||||0.46
71098182|NCT03572218|141704636|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.33|TWO_SIDED||||||Mixed Models Analysis|||Eating Concern||||0.33
71098183|NCT03572218|141704636|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.18|TWO_SIDED||||||Mixed Models Analysis|||Weight Concern||||0.18
71098184|NCT03572218|141704636|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.16|TWO_SIDED||||||Mixed Models Analysis|||Shape Concern||||0.16
71098185|NCT03572218|141704637|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|1.3||0.82|TWO_SIDED||||||Mixed Models Analysis|||Dietary Restraint||||0.82
71098186|NCT03572218|141704637|SUPERIORITY||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.8||0.45|TWO_SIDED||||||Mixed Models Analysis|||Disinhibition||||0.45
71098187|NCT03572218|141704637|SUPERIORITY||Mean Difference (Net)|-2.2|STANDARD_ERROR_OF_MEAN|0.8||0.007|TWO_SIDED||||||Mixed Models Analysis|||Hunger||||0.007
71098188|NCT03572218|141704638|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.3||0.23|TWO_SIDED||||||Mixed Models Analysis|||Self-Reported Weighing||||0.23
71098189|NCT03572218|141704638|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.48|TWO_SIDED||||||Mixed Models Analysis|||Track Food/Drink||||0.48
71098190|NCT03572218|141704638|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.4||0.89|TWO_SIDED||||||Mixed Models Analysis|||Track Calories||||0.89
71098191|NCT03572218|141704638|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.5||0.3|TWO_SIDED||||||Mixed Models Analysis|||Track Activity||||0.30
71098192|NCT03572218|141704639|SUPERIORITY|||||||0.32|||||||ANOVA|||BWL component||||0.32
71098193|NCT03572218|141704640|SUPERIORITY|||||||0.14|||||||ANOVA|||||||0.14
70986363|NCT00408421|141482767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29||||0.287||95.0|-0.82|0.24||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.24|-0.82|0.287
70986364|NCT00408421|141482768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64||||0.033||95.0|-1.23|-0.05||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.05|-1.23|0.033
71098194|NCT00286455|141704641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.001|TWO_SIDED|95.0|-0.76|-0.31||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint (HbA1c) as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=325 subjects had 95% power to detect a treatment difference as small as 0.5% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level and \>=80% of subjects meeting per protocol criteria.||-0.31|-0.76|<0.001
70986365|NCT00408421|141482769|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.78||||0.015||95.0|-1.4|-0.15||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.15|-1.40|0.015
70986366|NCT00408421|141482770|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56||||0.029||95.0|-1.06|-0.06||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.06|-1.06|0.029
70986367|NCT00408421|141482771|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Fisher Exact|||This study will also have at least 85% power to detect a treatment group difference of 25% in the response rates (≥30% reduction from baseline) based on the weekly mean of 24-hour average pain severity between duloxetine and placebo treatment groups.||||0.033
70986368|NCT00408421|141482772|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||Fisher Exact|||This study will also have at least 85% power to detect a treatment group difference of 25% in the response rates (≥30% reduction from baseline) based on the weekly mean of 24-hour average pain severity between duloxetine and placebo treatment groups.||||0.075
70986369|NCT00408421|141482773|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.83||||0.088||95.0|-0.28|3.94||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||3.94|-0.28|0.088
70986370|NCT00408421|141482774|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.87||||0.08||95.0|-0.22|3.96||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||3.96|-0.22|0.080
70986371|NCT00408421|141482775|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|||<|0.001||95.0|0.03|0.1||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.10|0.03|<0.001
71008812|NCT02055976|141525258|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.44143|STANDARD_ERROR_OF_MEAN|0.03183|<|0.001|TWO_SIDED|95.0|-0.50466|-0.37821|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.37821|-0.50466|<0.001
70986372|NCT00408421|141482776|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.23||||0.641||95.0|-1.19|0.74||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.74|-1.19|0.641
70986373|NCT00408421|141482777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.193||95.0|-1.17|0.24||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.24|-1.17|0.193
71037822|NCT00112437|141582581|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-16.64||||0.002||95.0|-28.84|-4.44||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 24 months.||-4.44|-28.84|0.002
71098195|NCT00286455|141704641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.001|TWO_SIDED|95.0|-0.8|-0.35|||ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint (HbA1c) as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=325 subjects had 95% power to detect a treatment difference as small as 0.5% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level and \>=80% of subjects meeting per protocol criteria.||-0.35|-0.80|<0.001
71098196|NCT00286455|141704642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|||<|0.001|TWO_SIDED|95.0|-0.39|-0.14||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.14|-0.39|<0.001
71098197|NCT00286455|141704642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.001|TWO_SIDED|95.0|-0.46|-0.21||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.21|-0.46|<0.001
71098198|NCT00286455|141704643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.57|-0.23||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.23|-0.57|<0.001
71098199|NCT00286455|141704643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|||<|0.001|TWO_SIDED|95.0|-0.68|-0.33||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.33|-0.68|<0.001
71098200|NCT00286455|141704644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|||<|0.001|TWO_SIDED|95.0|-0.63|-0.25||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.25|-0.63|<0.001
71098201|NCT00286455|141704644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.001|TWO_SIDED|95.0|-0.73|-0.35||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.35|-0.73|<0.001
71098202|NCT00286455|141704645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||<|0.001|TWO_SIDED|95.0|-0.68|-0.27||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.27|-0.68|<0.001
71098203|NCT00286455|141704645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.001|TWO_SIDED|95.0|-0.74|-0.33||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.33|-0.74|<0.001
71098204|NCT00286455|141704646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|||<|0.001|TWO_SIDED|95.0|-0.67|-0.24||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.24|-0.67|<0.001
71037823|NCT00112437|141582581|SUPERIORITY_OR_OTHER||Difference in Least Square Means|7.24||||0.852||95.0|-5.73|20.21||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 24 months.||20.21|-5.73|0.852
71098205|NCT00286455|141704646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|||<|0.001|TWO_SIDED|95.0|-0.7|-0.27||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.27|-0.70|<0.001
71098206|NCT00286455|141704647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.2||||0.002|TWO_SIDED|95.0|-21.5|-5.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-5.0|-21.5|0.002
71098207|NCT00286455|141704647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.7|||<|0.001|TWO_SIDED|95.0|-27.0|-10.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.4|-27.0|<0.001
71098208|NCT00286455|141704648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.4|||<|0.001|TWO_SIDED|95.0|-26.7|-10.1||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.1|-26.7|<0.001
70986374|NCT00408421|141482778|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA|ANOVA on ranked data.||An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Rank-transformed data will be used in the analysis given the view that the change scores for most of the laboratory analytes are not normally distributed. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||||0.003
70986375|NCT00408421|141482779|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA|ANOVA on ranked data.||An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Rank-transformed data will be used in the analysis given the view that the change scores for most of the laboratory analytes are not normally distributed. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||||0.026
70986376|NCT00408421|141482780|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8||||0.459||95.0|-1.32|2.92||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA||Mean Difference = Duloxetine minus Placebo|An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||2.92|-1.32|0.459
71037824|NCT00112437|141582581|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-0.39||||||95.0|-13.69|12.92|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 24 months.||12.92|-13.69|
71037825|NCT00112437|141582581|SUPERIORITY_OR_OTHER||Difference in Least Square Means|36.79||||||95.0|21.19|52.38|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 24 months.||52.38|21.19|
71098209|NCT00286455|141704648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.4|||<|0.001|TWO_SIDED|95.0|-29.7|-13.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-13.0|-29.7|<0.001
71098210|NCT00286455|141704649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.4|||<|0.001|TWO_SIDED|95.0|-27.1|-9.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.7|-27.1|<0.001
71098211|NCT00286455|141704649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.4|||<|0.001|TWO_SIDED|95.0|-33.2|-15.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-15.7|-33.2|<0.001
71098212|NCT00286455|141704650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.7||||0.001|TWO_SIDED|95.0|-26.8|-6.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-6.7|-26.8|0.001
71098213|NCT00286455|141704650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.3|||<|0.001|TWO_SIDED|95.0|-32.4|-12.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-12.2|-32.4|<0.001
70986377|NCT00408421|141482781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.09||||0.326||95.0|-1.1|3.28||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA||Mean Difference = Duloxetine minus Placebo|An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||3.28|-1.10|0.326
70986378|NCT00408421|141482782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.16||||0.069||95.0|-0.25|6.56||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA||Mean Difference = Duloxetine minus Placebo|An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||6.56|-0.25|0.069
70986379|NCT00408421|141482783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.54||||0.107||95.0|-1.2|0.12||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA||Mean Difference = Duloxetine minus Placebo|An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.12|-1.20|0.107
70986380|NCT02772965|141482784|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.08|TWO_SIDED|95.0|0.45|1.05|||Log Rank|||||1.05|0.45|0.08
70986381|NCT02772965|141482785|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.4||0.32|TWO_SIDED||||||Mixed Models Analysis|||||||0.32
70986382|NCT02772965|141482786|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|1.8||0.69|TWO_SIDED||||||Mixed Models Analysis|||||||0.69
70986383|NCT02772965|141482787|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|1.6||0.72|TWO_SIDED||||||Mixed Models Analysis|||||||0.72
70986384|NCT02772965|141482788|SUPERIORITY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|1.9||0.64|TWO_SIDED||||||Mixed Models Analysis|||||||0.64
70986385|NCT02772965|141482789|SUPERIORITY||Risk Ratio (RR)|0.71||||0.08|TWO_SIDED|95.0|0.49|1.04|||Chi-squared|||||1.04|0.49|0.08
70986386|NCT01614769|141482841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.41|||||TWO_SIDED|90.0|-22.98|51.8||||||||51.80|-22.98|
70986387|NCT01614769|141482841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.33|||||TWO_SIDED|90.0|-2.08|72.74||||||||72.74|-2.08|
70986388|NCT01614769|141482842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|90.0|-0.21|0.0||||||||0.00|-0.21|
70986389|NCT01614769|141482842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|||||TWO_SIDED|90.0|-0.24|-0.03||||||||-0.03|-0.24|
70986390|NCT01614769|141482843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.03|||||TWO_SIDED|90.0|-11.12|1.05||||||||1.05|-11.12|
70986391|NCT01614769|141482843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.27|||||TWO_SIDED|90.0|-13.3|-1.24||||||||-1.24|-13.30|
70986392|NCT04760314|141482849|SUPERIORITY||Risk Difference (RD)|22.6|||<|0.001|TWO_SIDED|95.0|11.6|33.6|||Cochran-Mantel-Haenszel|||||33.6|11.6|<0.001
70986393|NCT04760314|141482849|SUPERIORITY||Risk Difference (RD)|27.3|||<|0.001|TWO_SIDED|95.0|17.5|37.0|||Cochran-Mantel-Haenszel|||||37.0|17.5|<0.001
70986394|NCT04760314|141482850|SUPERIORITY||Risk Difference (RD)|33.2|||<|0.001|TWO_SIDED|95.0|20.6|45.8|||Cochran-Mantel-Haenszel|||||45.8|20.6|<0.001
70986395|NCT04760314|141482850|SUPERIORITY||Risk Difference (RD)|37.6|||<|0.001|TWO_SIDED|95.0|26.2|49.0|||Cochran-Mantel-Haenszel|||||49.0|26.2|<0.001
70986396|NCT04760314|141482851|SUPERIORITY||LS Mean Difference|-34.5|||<|0.001|TWO_SIDED|95.0|-44.1|-24.9|||ANCOVA|||||-24.9|-44.1|<0.001
70986397|NCT04760314|141482851|SUPERIORITY||LS Mean Difference|-38.99|||<|0.001|TWO_SIDED|95.0|-47.7|-30.3|||ANCOVA|||||-30.3|-47.7|<0.001
70986398|NCT04760314|141482852|SUPERIORITY||Risk Difference (RD)|18.4||||0.003|TWO_SIDED|95.0|6.8|29.9|||Cochran-Mantel-Haenszel|||||29.9|6.8|0.003
70986399|NCT04760314|141482852|SUPERIORITY||Risk Difference (RD)|24.2|||<|0.001|TWO_SIDED|95.0|13.9|34.5|||Cochran-Mantel-Haenszel|||||34.5|13.9|<0.001
70986400|NCT04760314|141482853|SUPERIORITY||Risk Difference (RD)|1.2||||0.404|TWO_SIDED|95.0|-1.2|3.6|||Cochran-Mantel-Haenszel|||||3.6|-1.2|0.404
70986401|NCT04760314|141482854|SUPERIORITY||Risk Difference (RD)|1.8||||0.294|TWO_SIDED|95.0|-1.6|5.1|||Cochran-Mantel-Haenszel|||||5.1|-1.6|0.294
70986402|NCT04760314|141482854|SUPERIORITY||Risk Difference (RD)|3.7||||0.138|TWO_SIDED|95.0|-0.5|7.8|||Cochran-Mantel-Haenszel|||||7.8|-0.5|0.138
70986403|NCT04760314|141482855|SUPERIORITY||Risk Difference (RD)|9.2||||0.013|TWO_SIDED|95.0|1.8|16.5|||Cochran-Mantel-Haenszel|||||16.5|1.8|0.013
70986404|NCT04760314|141482855|SUPERIORITY||Risk Difference (RD)|16.2||||0.001|TWO_SIDED|95.0|8.1|24.3|||Cochran-Mantel-Haenszel|||||24.3|8.1|0.001
70986405|NCT04760314|141482856|SUPERIORITY||Risk Difference (RD)|20.6||||0.001|TWO_SIDED|95.0|8.7|32.4|||Cochran-Mantel-Haenszel|||||32.4|8.7|0.001
70986406|NCT04760314|141482856|SUPERIORITY||Risk Difference (RD)|29.2|||<|0.001|TWO_SIDED|95.0|17.9|40.4|||Cochran-Mantel-Haenszel|||||40.4|17.9|<0.001
70986407|NCT01290484|141482857|SUPERIORITY_OR_OTHER||Mean percentage volume change|-3.47||||||||||||||||||
70986408|NCT00960440|141482858|SUPERIORITY_OR_OTHER||Percentage Difference|23.69|STANDARD_ERROR_OF_MEAN|5.73|<|0.0001|TWO_SIDED|95.0|12.45|34.92||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 10 mg to placebo and 2-sided 95% confidence interval (CI) was evaluated for the difference in percentages.||34.92|12.45|<0.0001
70986409|NCT00960440|141482858|SUPERIORITY_OR_OTHER||Percentage Difference|17.23|STANDARD_ERROR_OF_MEAN|5.7||0.0024|TWO_SIDED|95.0|6.06|28.41||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||28.41|6.06|0.0024
70986410|NCT00960440|141482859|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.38|-0.17||A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo in ACR20 had to be significant.|Mixed Models Analysis|||Least squares mean difference (LS Mean Difference) and corresponding 95% CI was calculated using a mixed effect repeated measure model with treatment, visit, treatment by visit interaction, and geographic region as fixed effects and participants as a random effect.||-0.17|-0.38|<0.0001
70986411|NCT00960440|141482859|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.36|-0.15||Step-down procedure: For the comparison of 5 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo as well as the comparison of 5 mg to placebo in ACR20 had to be statistically significant.|Mixed Models Analysis|||LS Mean Difference and corresponding 95% CI was calculated using a mixed effect repeated measure model with treatment, visit, treatment by visit interaction, and geographic region as fixed effects and participants as a random effect.||-0.15|-0.36|<0.0001
70986412|NCT00960440|141482860|SUPERIORITY_OR_OTHER||Percentage Difference|9.53|STANDARD_ERROR_OF_MEAN|3.05||0.0017|TWO_SIDED|95.0|3.54|15.51||A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo in HAQ-DI had to be statistically significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 10 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||15.51|3.54|0.0017
70986413|NCT00960440|141482860|SUPERIORITY_OR_OTHER||Percentage Difference|5.05|STANDARD_ERROR_OF_MEAN|2.57||0.0496|TWO_SIDED|95.0|0.0|10.1||Step-down procedure: For the comparison of 5 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo as well as comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||10.10|0.00|0.0496
70986414|NCT02345161|141482919|SUPERIORITY_OR_OTHER||Adjusted LS mean difference|0.171|STANDARD_ERROR_OF_MEAN|0.0118|<|0.001|TWO_SIDED|95.0|0.148|0.194|||Mixed Model Repeated Measures|||||0.194|0.148|<0.001
70986415|NCT02345161|141482920|SUPERIORITY_OR_OTHER||Adjusted LS mean difference|0.179|STANDARD_ERROR_OF_MEAN|0.0242|<|0.001|TWO_SIDED|95.0|0.131|0.226|||Mixed Model Repeated Measures|||||0.226|0.131|<0.001
70986416|NCT02345161|141482921|SUPERIORITY_OR_OTHER||Adjusted LS mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-3.5|-1.0|||Mixed Model Repeated Measures|||||-1.0|-3.5|<0.001
70986417|NCT02345161|141482922|SUPERIORITY_OR_OTHER||Adjusted LS mean difference|-2.7|STANDARD_ERROR_OF_MEAN|1.44||0.065|TWO_SIDED|95.0|-5.5|0.2|||Mixed Model Repeated Measures|||||0.2|-5.5|0.065
70986418|NCT02345161|141482923|SUPERIORITY_OR_OTHER||LS Mean difference|0.57|STANDARD_ERROR_OF_MEAN|0.138|<|0.001|TWO_SIDED|95.0|0.3|0.84|||Mixed effect repeated measures model|||||0.84|0.30|<0.001
70986419|NCT02345161|141482924|SUPERIORITY_OR_OTHER||LS Mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.317||0.279|TWO_SIDED|95.0|-0.28|0.97|||Mixed effect repeated measures model|||||0.97|-0.28|0.279
70986420|NCT02345161|141482925|SUPERIORITY_OR_OTHER||LS Mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.51||0.817|TWO_SIDED|95.0|-0.9|1.1|||ANCOVA|||||1.1|-0.9|0.817
70986421|NCT02345161|141482926|SUPERIORITY_OR_OTHER||LS Mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.95||0.767|TWO_SIDED|95.0|-2.1|1.6|||ANCOVA|||||1.6|-2.1|0.767
70986422|NCT02345161|141482927|SUPERIORITY_OR_OTHER||Rate ratio|0.65||||0.002|TWO_SIDED|95.0|0.49|0.86|||Generalized linear modeL|Generalized linear model assuming a negative binomial distribution||||0.86|0.49|0.002
70986423|NCT02345161|141482928|SUPERIORITY_OR_OTHER||Rate ratio|0.56||||0.006|TWO_SIDED|95.0|0.37|0.85|||Generalized Linear model|Generalized linear model assuming a negative binomial distribution||||0.85|0.37|0.006
70986424|NCT02345161|141482929|SUPERIORITY_OR_OTHER||LS Mean difference|-0.95|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-1.25|-0.66|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 1-4|||-0.66|-1.25|<0.001
70986425|NCT02345161|141482929|SUPERIORITY_OR_OTHER||LS Mean difference|-1.23|STANDARD_ERROR_OF_MEAN|0.183|<|0.001|TWO_SIDED|95.0|-1.59|-0.87|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 5-8|||-0.87|-1.59|<0.001
70986426|NCT02345161|141482929|SUPERIORITY_OR_OTHER||LS Mean difference|-1.18|STANDARD_ERROR_OF_MEAN|0.201|<|0.001|TWO_SIDED|95.0|-1.57|-0.78|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 9-12|||-0.78|-1.57|<0.001
70986427|NCT02345161|141482929|SUPERIORITY_OR_OTHER||LS Mean difference|-1.33|STANDARD_ERROR_OF_MEAN|0.213|<|0.001|TWO_SIDED|95.0|-1.75|-0.91|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 13-16|||-0.91|-1.75|<0.001
70986428|NCT02345161|141482929|SUPERIORITY_OR_OTHER||LS Mean difference|-1.41|STANDARD_ERROR_OF_MEAN|0.223|<|0.001|TWO_SIDED|95.0|-1.85|-0.97|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 17-20|||-0.97|-1.85|<0.001
70986429|NCT02345161|141482929|SUPERIORITY_OR_OTHER||Mixed Model Repeated Measures|-1.35|STANDARD_ERROR_OF_MEAN|0.224|<|0.001|TWO_SIDED|95.0|-1.79|-0.91|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 21-24|||-0.91|-1.79|<0.001
70986430|NCT02345161|141482929|SUPERIORITY_OR_OTHER||LS Mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.67|-0.36|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 1-4|||-0.36|-0.67|<0.001
70986431|NCT02345161|141482929|SUPERIORITY_OR_OTHER||LS Mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.098|<|0.001|TWO_SIDED|95.0|-0.88|-0.5|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 5-8|||-0.50|-0.88|<0.001
70986432|NCT02345161|141482929|SUPERIORITY_OR_OTHER||LS Mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.108|<|0.001|TWO_SIDED|95.0|-0.9|-0.48|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 9-12|||-0.48|-0.90|<0.001
70986433|NCT02345161|141482929|SUPERIORITY_OR_OTHER||LS Mean difference|-0.75|STANDARD_ERROR_OF_MEAN|0.115|<|0.001|TWO_SIDED|95.0|-0.97|-0.52|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 13-16|||-0.52|-0.97|<0.001
71037826|NCT00112437|141582582|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-21.49||||0.011|TWO_SIDED|95.0|-39.55|-3.43||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 24 months.||-3.43|-39.55|0.011
71037827|NCT00112437|141582582|SUPERIORITY_OR_OTHER||Difference in Least square means|13.31||||0.618||95.0|-7.1|33.71||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least square means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 24 months.||33.71|-7.10|0.618
71037828|NCT00112437|141582582|SUPERIORITY_OR_OTHER||Difference in Least square means|7.77|||||TWO_SIDED|95.0|-13.46|29.01|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 24 months.||29.01|-13.46|
71098214|NCT00286455|141704651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.5||||0.002|TWO_SIDED|95.0|-26.8|-6.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-6.2|-26.8|0.002
71098215|NCT00286455|141704651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.2|||<|0.001|TWO_SIDED|95.0|-31.6|-10.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.8|-31.6|<0.001
70986434|NCT02345161|141482929|SUPERIORITY_OR_OTHER||LS Mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-1.03|-0.56|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 17-20|||-0.56|-1.03|<0.001
70986435|NCT02345161|141482929|SUPERIORITY_OR_OTHER||LS Mean difference|-0.77|STANDARD_ERROR_OF_MEAN|0.122|<|0.001|TWO_SIDED|95.0|-1.01|-0.54|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 21-24|||-0.54|-1.01|<0.001
70986436|NCT02345161|141482929|SUPERIORITY_OR_OTHER||LS Mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.044|<|0.001|TWO_SIDED|95.0|-0.26|-0.09|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 1-4|||-0.09|-0.26|<0.001
70986437|NCT02345161|141482929|SUPERIORITY_OR_OTHER||LS Mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.053|<|0.001|TWO_SIDED|95.0|-0.31|-0.1|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 5-8|||-0.10|-0.31|<0.001
70986438|NCT02345161|141482929|SUPERIORITY_OR_OTHER||LS Mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.058||0.004|TWO_SIDED|95.0|-0.28|-0.05|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 9-12|||-0.05|-0.28|0.004
70986439|NCT02345161|141482929|SUPERIORITY_OR_OTHER||LS Mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.061|<|0.001|TWO_SIDED|95.0|-0.34|-0.1|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 13-16|||-0.10|-0.34|<0.001
70986440|NCT02345161|141482929|SUPERIORITY_OR_OTHER||LS Mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.064|<|0.001|TWO_SIDED|95.0|-0.36|-0.11|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 17-20|||-0.11|-0.36|<0.001
70986441|NCT02345161|141482929|SUPERIORITY_OR_OTHER||LS Mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.065|<|0.001|TWO_SIDED|95.0|-0.35|-0.1|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 21-24|||-0.10|-0.35|<0.001
70986442|NCT02345161|141482929|SUPERIORITY_OR_OTHER||LS Mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.049|<|0.001|TWO_SIDED|95.0|-0.37|-0.18|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 1-4|||-0.18|-0.37|<0.001
70986443|NCT02345161|141482929|SUPERIORITY_OR_OTHER||LS Mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.46|-0.23|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 5-8|||-0.23|-0.46|<0.001
70986444|NCT02345161|141482929|SUPERIORITY_OR_OTHER||LS Mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.066|<|0.001|TWO_SIDED|95.0|-0.47|-0.21|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 9-12|||-0.21|-0.47|<0.001
70986445|NCT02345161|141482929|SUPERIORITY_OR_OTHER||LS Mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.068|<|0.001|TWO_SIDED|95.0|-0.51|-0.25|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 13-16|||-0.25|-0.51|<0.001
71098216|NCT00286455|141704652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.8|||<|0.001|TWO_SIDED|95.0|-30.9|-8.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.7|-30.9|<0.001
70986446|NCT02345161|141482929|SUPERIORITY_OR_OTHER||LS Mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|95.0|-0.53|-0.26|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 17-20|||-0.26|-0.53|<0.001
70986447|NCT02345161|141482929|SUPERIORITY_OR_OTHER||LS Mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.072|<|0.001|TWO_SIDED|95.0|-0.5|-0.22|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 21-24|||-0.22|-0.50|<0.001
70986448|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.311||0.094|TWO_SIDED|95.0|-1.13|0.09|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 1-4|||0.09|-1.13|0.094
70986449|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-1.07|STANDARD_ERROR_OF_MEAN|0.371||0.004|TWO_SIDED|95.0|-1.8|-0.34|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 5-8|||-0.34|-1.80|0.004
70986450|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.97|STANDARD_ERROR_OF_MEAN|0.419||0.022|TWO_SIDED|95.0|-1.79|-0.14|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 9-12|||-0.14|-1.79|0.022
70986451|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-1.01|STANDARD_ERROR_OF_MEAN|0.445||0.024|TWO_SIDED|95.0|-1.88|-0.13|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 13-16|||-0.13|-1.88|0.024
70986452|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-1.11|STANDARD_ERROR_OF_MEAN|0.481||0.021|TWO_SIDED|95.0|-2.06|-0.17|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 17-20|||-0.17|-2.06|0.021
70986453|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-1.11|STANDARD_ERROR_OF_MEAN|0.481||0.022|TWO_SIDED|95.0|-2.05|-0.16|||Mixed Model Repeated Measures||EXACT-RS Score, Week 21-24|||-0.16|-2.05|0.022
70986454|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-1.32|STANDARD_ERROR_OF_MEAN|0.492||0.008|TWO_SIDED|95.0|-2.29|-0.35|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 25-28|||-0.35|-2.29|0.008
70986455|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-1.43|STANDARD_ERROR_OF_MEAN|0.494||0.004|TWO_SIDED|95.0|-2.4|-0.46|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 29-32|||-0.46|-2.40|0.004
70986456|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.519||0.004|TWO_SIDED|95.0|-2.52|-0.48|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 33-36|||-0.48|-2.52|0.004
70986457|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-1.23|STANDARD_ERROR_OF_MEAN|0.507||0.016|TWO_SIDED|95.0|-2.22|-0.23|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 37-40|||-0.23|-2.22|0.016
70986458|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-1.49|STANDARD_ERROR_OF_MEAN|0.513||0.04|TWO_SIDED|95.0|-2.5|-0.48|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 41-44|||-0.48|-2.50|0.04
70986459|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-1.53|STANDARD_ERROR_OF_MEAN|0.525||0.007|TWO_SIDED|95.0|-2.56|-0.5|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 45-49|||-0.50|-2.56|0.007
70986460|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-1.42|STANDARD_ERROR_OF_MEAN|0.524||0.007|TWO_SIDED|95.0|-2.45|-0.39|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 49-52|||-0.39|-2.45|0.007
70986461|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.169||0.051|TWO_SIDED|95.0|-0.66|0.0|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 1-4|||0.00|-0.66|0.051
70986462|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.207||0.003|TWO_SIDED|95.0|-1.02|-0.2|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 5-8|||-0.20|-1.02|0.003
70986463|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.234||0.01|TWO_SIDED|95.0|-1.07|-0.15|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 9-12|||-0.15|-1.07|0.010
70986464|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.62|STANDARD_ERROR_OF_MEAN|0.247||0.013|TWO_SIDED|95.0|-1.1|-0.13|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 13-16|||-0.13|-1.10|0.013
70986465|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.265||0.012|TWO_SIDED|95.0|-1.19|-0.15|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 17-20|||-0.15|-1.19|0.012
70986466|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.268||0.018|TWO_SIDED|95.0|-1.16|-0.11|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 21-24|||-0.11|-1.16|0.018
70986467|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.275||0.006|TWO_SIDED|95.0|-1.3|-0.21|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 25-28|||-0.21|-1.30|0.006
70986468|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.85|STANDARD_ERROR_OF_MEAN|0.276||0.002|TWO_SIDED|95.0|-1.4|-0.31|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 29-32|||-0.31|-1.40|0.002
70986469|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.95|STANDARD_ERROR_OF_MEAN|0.288||0.001|TWO_SIDED|95.0|-1.51|-0.38|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 33-36|||-0.38|-1.51|0.001
70986470|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.287||0.008|TWO_SIDED|95.0|-1.32|-0.2|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 37-40|||-0.20|-1.32|0.008
70986471|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.294||0.006|TWO_SIDED|95.0|-1.4|-0.24|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 41-44|||-0.24|-1.40|0.006
70986472|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.85|STANDARD_ERROR_OF_MEAN|0.299||0.004|TWO_SIDED|95.0|-1.44|-0.27|||Breathlessness score, Week 41-44||Breathlessness EXACT-RS score, Week 45-48|||-0.27|-1.44|0.004
70986473|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.294||0.003|TWO_SIDED|95.0|-1.45|-0.3|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 49-52EXA|||-0.30|-1.45|0.003
70986474|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.091||0.84|TWO_SIDED|95.0|-0.2|0.16|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 1-4|||0.16|-0.20|0.840
70986475|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.106||0.167|TWO_SIDED|95.0|-0.36|-0.06|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 5-8|||-0.06|-0.36|0.167
70986476|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.117||0.359|TWO_SIDED|95.0|-0.34|0.12|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 9-12|||0.12|-0.34|0.359
70986477|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.124||0.36|TWO_SIDED|95.0|-0.36|0.13|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 13-16|||0.13|-0.36|0.360
70986478|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.134||0.49|TWO_SIDED|95.0|-0.36|0.17|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 17-20|||0.17|-0.36|0.490
70986479|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.138||0.388|TWO_SIDED|95.0|-0.39|0.15|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 21-24|||0.15|-0.39|0.388
70986480|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.137||0.218|TWO_SIDED|95.0|-0.44|0.1|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 25-28|||0.10|-0.44|0.218
70986481|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.136||0.138|TWO_SIDED|95.0|-0.47|0.07|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 29-32|||0.07|-0.47|0.138
70986482|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.239|TWO_SIDED|95.0|-0.44|0.11|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 33-36|||0.11|-0.44|0.239
70986483|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.138||0.417|TWO_SIDED|95.0|-0.38|0.16|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 37-40|||0.16|-0.38|0.417
70986484|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.144||0.078|TWO_SIDED|95.0|-0.54|0.03|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 41-44|||0.03|-0.54|0.078
70986485|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.14||0.058|TWO_SIDED|95.0|-0.54|0.01|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 45-48|||0.01|-0.54|0.058
70986486|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.141||0.231|TWO_SIDED|95.0|-0.45|0.11|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 49-52|||0.11|-0.45|0.231
70986487|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.097||0.068|TWO_SIDED|95.0|-0.37|0.01|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 1-4|||0.01|-0.37|0.068
70986488|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.118||0.006|TWO_SIDED|95.0|-0.56|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 5-8|||-0.09|-0.56|0.006
70986489|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.131||0.042|TWO_SIDED|95.0|-0.53|-0.01|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 9-12|||-0.01|-0.53|0.042
70986490|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.136||0.027|TWO_SIDED|95.0|-0.57|-0.03|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 13-16|||-0.03|-0.57|0.027
70986491|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.146||0.01|TWO_SIDED|95.0|-0.67|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 17-20|||-0.09|-0.67|0.010
70986492|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.144||0.01|TWO_SIDED|95.0|-0.66|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 21-24|||-0.09|-0.66|0.010
70986493|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.148|||TWO_SIDED|95.0|-0.7|-0.12|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 25-28|||-0.12|-0.70|
70986494|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.152||0.011|TWO_SIDED|95.0|-0.68|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 29-32|||-0.09|-0.68|0.011
70986495|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.157||0.011|TWO_SIDED|95.0|-0.71|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 33-36|||-0.09|-0.71|0.011
70986496|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.151||0.014|TWO_SIDED|95.0|-0.67|-0.07|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 37-40|||-0.07|-0.67|0.014
70986497|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.153||0.007|TWO_SIDED|95.0|-0.72|-0.12|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 41-44|||-0.12|-0.72|0.007
70986498|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.16||0.006|TWO_SIDED|95.0|-0.76|-0.13|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 45-48|||-0.13|-0.76|0.006
70986499|NCT02345161|141482930|SUPERIORITY_OR_OTHER||LS Mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.163||0.013|TWO_SIDED|95.0|-0.73|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 49-52|||-0.09|-0.73|0.013
70986500|NCT02345161|141482939|SUPERIORITY_OR_OTHER||LS mean difference|1.8|STANDARD_ERROR_OF_MEAN|0.81||0.023|TWO_SIDED|95.0|0.3|3.4|||Mixed Model Repeated Measures||For QTcF|||3.4|0.3|0.023
70986501|NCT02345161|141482939|SUPERIORITY_OR_OTHER||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.78||0.471|TWO_SIDED|95.0|-2.1|1.0|||Mixed Model Repeated Measures||For PR interval|||1.0|-2.1|0.471
70986502|NCT02345161|141482940|SUPERIORITY_OR_OTHER||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.83||0.564|TWO_SIDED|95.0|-4.7|2.5|||Mixed Model Repeated Measures||For QTcF|||2.5|-4.7|0.564
70986503|NCT02345161|141482940|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|1.57||0.908|TWO_SIDED|95.0|-2.9|3.3|||Mixed Model Repeated Measures||For PR interval|||3.3|-2.9|0.908
70986504|NCT02345161|141482943|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.56||0.849|TWO_SIDED|95.0|-1.0|1.2|||Mixed Model Repeated Measures||Week 24, SBP|||1.2|-1.0|0.849
70986505|NCT02345161|141482943|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.38||0.613|TWO_SIDED|95.0|-0.6|0.9|||Mixed Model Repeated Measures||Week 24, DBP|||0.9|-0.6|0.613
70986506|NCT02345161|141482944|SUPERIORITY_OR_OTHER||: LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|1.19||0.183|TWO_SIDED|95.0|-3.9|0.8|||Mixed Model Repeated Measures||Week 52, SBP|||0.8|-3.9|0.183
70986507|NCT02345161|141482944|SUPERIORITY_OR_OTHER||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.75||0.253|TWO_SIDED|95.0|-2.3|0.6|||Mixed Model Repeated Measures||Week 52, DBP|||0.6|-2.3|0.253
70986508|NCT02345161|141482946|SUPERIORITY_OR_OTHER||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.45||0.526|TWO_SIDED|95.0|-0.6|1.2|||Mixed Model Repeated Measures|||||1.2|-0.6|0.526
71037829|NCT00112437|141582582|SUPERIORITY_OR_OTHER||Difference in Least Square Means|49.23|||||TWO_SIDED|95.0|23.86|74.59|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 24 months.||74.59|23.86|
71037830|NCT00112437|141582583|SUPERIORITY_OR_OTHER||Difference in Least Square Means|6.45|||||TWO_SIDED|95.0|3.38|9.53||||||In postmenopausal women with osteoporosis assess the time course of resolution of effect on lumbar spine BMD during the 12 month extension following 24 months of treatment with odanacatib once weekly. The primary objective was to assess the resolution of effect, on lumbar spine BMD, for the participants who received odanacatib 50 mg for 3 years compared to those who received odanacatib 50 mg in the 2nd year and switched to placebo for the 3rd year extension.||9.53|3.38|
71037831|NCT00112437|141582584|SUPERIORITY_OR_OTHER||Difference in Least Square Means|6.31|||||TWO_SIDED|95.0|3.44|9.17||||||||9.17|3.44|
70986509|NCT02345161|141482947|SUPERIORITY_OR_OTHER||LS mean difference|2.6|STANDARD_ERROR_OF_MEAN|0.96||0.007|TWO_SIDED|95.0|0.7|4.5|||Mixed Model Repeated Measures|||||4.5|0.7|0.007
70986510|NCT02238028|141482970|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Paired t-test,2 sided|||Paired Student's t tests were used in the absence and presence of wearing respirators. HRV was log-transformed before regression analyses. Linear mixed-effect models were applied to investigate the effects of wearing respirators. Age, sex, body mass index, PM2.5 concentration, 48-h mean temperature and 48-h mean humidity were introduced into the model as fixed-effect terms. At last, we incorporated random-effect intercepts for subjects to account for correlations between repeated measurements.||||<0.05
70986511|NCT02238028|141482971|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Paired t-test,2 sided|||||||<0.05
70986513|NCT02606045|141483005|SUPERIORITY||Mean Difference (Final Values)|46.0||||0.039|TWO_SIDED|95.0|2.0|90.0|||Mixed Models Analysis|||||90|2|0.039
70986514|NCT02606045|141483006|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.998|TWO_SIDED|95.0|-0.7|0.7|||Mixed Models Analysis|||||0.7|-0.7|0.998
70986515|NCT02606045|141483007|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.168|TWO_SIDED|95.0|-1.0|5.8|||Mixed Models Analysis|||||5.8|-1.0|0.168
71098217|NCT00286455|141704652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.4|||<|0.001|TWO_SIDED|95.0|-34.6|-12.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-12.2|-34.6|<0.001
70986516|NCT02606045|141483008|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.055|TWO_SIDED|95.0|-4.9|0.1|||Mixed Models Analysis|||||0.1|-4.9|0.055
70986517|NCT02606045|141483009|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.681|TWO_SIDED|95.0|-4.8|3.2|||Mixed Models Analysis|||||3.2|-4.8|0.681
70986518|NCT02606045|141483009|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.633|TWO_SIDED|95.0|-12.4|7.6|||Mixed Models Analysis|||Role limitations of physical health||7.6|-12.4|0.633
70986519|NCT02606045|141483009|SUPERIORITY||Mean Difference (Final Values)|4.8||||0.362|TWO_SIDED|95.0|-5.7|15.3|||Mixed Models Analysis|||Role limitations of emotional health||15.3|-5.7|0.362
70986520|NCT02606045|141483009|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.375|TWO_SIDED|95.0|-7.4|2.8|||Mixed Models Analysis|||Energy/fatigue||2.8|-7.4|0.375
70986521|NCT02606045|141483009|SUPERIORITY||Mean Difference (Final Values)|3.6||||0.068|TWO_SIDED|95.0|-0.3|7.4|||Mixed Models Analysis|||Emotional well-being||7.4|-0.3|0.068
70986522|NCT02606045|141483009|SUPERIORITY||Mean Difference (Final Values)|4.5||||0.189|TWO_SIDED|95.0|-2.3|11.3|||Mixed Models Analysis|||Social functioning||11.3|-2.3|0.189
70986523|NCT02606045|141483009|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.489|TWO_SIDED|95.0|-9.2|4.5|||Mixed Models Analysis|||Pain||4.5|-9.2|0.489
70986524|NCT02606045|141483009|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.786|TWO_SIDED|95.0|-3.2|4.3|||Mixed Models Analysis|||General Health||4.3|-3.2|0.786
71098218|NCT00286455|141704653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.3|||<|0.001|TWO_SIDED|95.0|-30.6|-8.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.0|-30.6|<0.001
70986525|NCT02606045|141483010|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.098|TWO_SIDED|95.0|-2.3|0.2|||Mixed Models Analysis|||Physically Unhealthy Days||0.2|-2.3|0.098
70986526|NCT02606045|141483010|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.557|TWO_SIDED|95.0|-1.6|3.0|||Mixed Models Analysis|||Mentally Unhealthy Days||3.0|-1.6|0.557
70986527|NCT02606045|141483011|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.266|TWO_SIDED|95.0|0.8|2.7|||Mixed Models Analysis|||Cycle Severity Rating||2.7|0.8|0.266
70986528|NCT00907881|141483012|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Regression, Linear|Pearson correlation coefficient||||||0.0002
70986529|NCT01671085|141483020|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-50.49|||<|0.001|TWO_SIDED|90.0|-71.27|-29.7||P-value is for Day 43.|Mixed Effects Model Analysis|||||-29.70|-71.27|<0.001
70986530|NCT01671085|141483020|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-45.11|||<|0.001|TWO_SIDED|90.0|-65.91|-24.31||P-value is for Day 57.|Mixed Effects Models Analysis|||||-24.31|-65.91|<0.001
70986531|NCT00637273|141483021|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.131|<|0.0001|TWO_SIDED|95.0|0.37|0.89||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANOVA|Analysis of Variance (ANOVA) model includes treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors.||Null hypothesis: no difference across treatments. Alternative hypothesis: a difference exists between exenatide once weekly and at least one comparator group (sitagliptin or pioglitazone). Power: Assuming 10% dropout, delta=0.5%, and common SD=1.2%, 450 subjects would provide \>90% power to detect a treatment difference (alpha=0.05, two-sided) in the change in HbA1c between exenatide once weekly and sitagliptin or pioglitazone, with Hochberg's multiplicity adjustment method.||0.89|0.37|<.0001
70986532|NCT00637273|141483021|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.131||0.0165|TWO_SIDED|95.0|0.06|0.57||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANOVA|Analysis of Variance (ANOVA) model includes treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors.||Null hypothesis: no difference across treatments. Alternative hypothesis: a difference exists between exenatide once weekly and at least one comparator group (sitagliptin or pioglitazone). Power: Assuming 10% dropout, delta=0.5%, and common SD=1.2%, 450 subjects would provide \>90% power to detect a treatment difference (alpha=0.05, two-sided) in the change in HbA1c between exenatide once weekly and sitagliptin or pioglitazone, with Hochberg's multiplicity adjustment method.||0.57|0.06|0.0165
70986533|NCT00637273|141483022|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentage of subjects achieving HbA1c target of \<7% at Week 26 were compared between treatments using a Cochran Mantel Haenszel (CMH) test, in which baseline HbA1c stratum (\<9% or \>=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||||<.0001
70986534|NCT00637273|141483022|SUPERIORITY_OR_OTHER|||||||0.0015|TWO_SIDED|||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentage of subjects achieving HbA1c target of \<7% at Week 26 were compared between treatments using a Cochran Mantel Haenszel (CMH) test, in which baseline HbA1c stratum (\<9% or \>=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||||0.0015
70986535|NCT00637273|141483023|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target of \<=6.5% at Week 26 were compared between treatments using a CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||||<.0001
70986536|NCT00637273|141483023|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target of \<=6.5% at Week 26 were compared between treatments using a CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||||0.0120
70986537|NCT00637273|141483024|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target of \<=6.0% at Week 26 were compared between treatments using a CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||||0.1700
70986538|NCT00637273|141483024|SUPERIORITY_OR_OTHER|||||||0.0091|TWO_SIDED|||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target of \<=6.0% at Week 26 were compared between treatments using a CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||||0.0091
70986539|NCT00637273|141483025|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.54|STANDARD_ERROR_OF_MEAN|0.416||0.0002|TWO_SIDED|95.0|0.72|2.35||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in body weight from baseline (Day 1) to Week 26 was analyzed by an analysis of covariance (ANCOVA) model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of body weight as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||2.35|0.72|0.0002
70986540|NCT00637273|141483025|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.1|STANDARD_ERROR_OF_MEAN|0.415|<|0.0001|TWO_SIDED|95.0|4.28|5.91||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in body weight from baseline (Day 1) to Week 26 was analyzed by an analysis of covariance (ANCOVA) model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of body weight as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||5.91|4.28|<.0001
71037832|NCT00112437|141582585|SUPERIORITY_OR_OTHER||Difference in Least Square Means|2.71|||||TWO_SIDED|95.0|-0.16|5.57||||||||5.57|-0.16|
71037833|NCT00112437|141582586|SUPERIORITY_OR_OTHER||Difference in Least Square Means|8.13|||||TWO_SIDED|95.0|3.8|12.46||||||||12.46|3.80|
70986541|NCT00637273|141483026|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|15.5|STANDARD_ERROR_OF_MEAN|4.95||0.0038|TWO_SIDED|95.0|5.7|25.2||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting plasma glucose from baseline (Day 1) to Week 26 was analyzed using an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting plasma glucose as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||25.2|5.7|0.0038
70986542|NCT00637273|141483026|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.4|STANDARD_ERROR_OF_MEAN|4.98||0.3729|TWO_SIDED|95.0|-5.3|14.2||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting plasma glucose from baseline (Day 1) to Week 26 was analyzed using an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting plasma glucose as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||14.2|-5.3|0.3729
70986543|NCT00637273|141483027|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|1.26||0.0055|TWO_SIDED|95.0|1.3|6.3||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in systolic blood pressure from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of systolic blood pressure as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||6.3|1.3|0.0055
71037834|NCT00112437|141582587|SUPERIORITY_OR_OTHER||Difference in Least Square Means|1.46|||||TWO_SIDED|95.0|-1.54|4.46||||||||4.46|-1.54|
71037835|NCT00112437|141582588|SUPERIORITY_OR_OTHER||Difference in Least Square Means|2.47|||||TWO_SIDED|95.0|-0.93|5.88||||||||5.88|-0.93|
71037836|NCT00112437|141582589|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-78.06|||||TWO_SIDED|95.0|-119.2|-36.92||||||||-36.92|-119.20|
71037837|NCT00112437|141582590|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-34.25|||||TWO_SIDED|95.0|-78.7|10.2||||||||10.20|-78.70|
71037838|NCT00112437|141582591|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-39.25|||||TWO_SIDED|95.0|-87.17|8.68||||||||8.68|-87.17|
71037839|NCT00112437|141582592|SUPERIORITY_OR_OTHER||Difference in Least Square Means|16.59|||||TWO_SIDED|95.0|-5.67|38.85||||||||38.85|-5.67|
71008813|NCT02055976|141525258|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.46235|STANDARD_ERROR_OF_MEAN|0.03148|<|0.001|TWO_SIDED|95.0|-0.52491|-0.3998|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.39980|-0.52491|<0.001
71008814|NCT02055976|141525258|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.26949|STANDARD_ERROR_OF_MEAN|0.02615|<|0.001|TWO_SIDED|95.0|-0.32142|-0.21755|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.21755|-0.32142|<0.001
71008815|NCT02055976|141525258|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.37493|STANDARD_ERROR_OF_MEAN|0.02649|<|0.001|TWO_SIDED|95.0|-0.42754|-0.32231|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.32231|-0.42754|<0.001
71008816|NCT02055976|141525258|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.41199|STANDARD_ERROR_OF_MEAN|0.02676|<|0.001|TWO_SIDED|95.0|-0.46512|-0.35886|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.35886|-0.46512|<0.001
71008817|NCT02055976|141525258|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.31806|STANDARD_ERROR_OF_MEAN|0.02979|<|0.001|TWO_SIDED|95.0|-0.37723|-0.25888|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.25888|-0.37723|<0.001
71008818|NCT02055976|141525258|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.42583|STANDARD_ERROR_OF_MEAN|0.02932|<|0.001|TWO_SIDED|95.0|-0.48409|-0.36758|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.36758|-0.48409|<0.001
71008819|NCT02055976|141525258|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.45501|STANDARD_ERROR_OF_MEAN|0.02912|<|0.001|TWO_SIDED|95.0|-0.51287|-0.39715|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.39715|-0.51287|<0.001
71008820|NCT02055976|141525259|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-49.42411|STANDARD_ERROR_OF_MEAN|3.72907|<|0.001|TWO_SIDED|95.0|-56.83019|-42.01803|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-42.01803|-56.83019|<0.001
71037840|NCT00112437|141582593|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-5.43|||||TWO_SIDED|95.0|-42.04|31.18||||||||31.18|-42.04|
71037841|NCT00112437|141582594|SUPERIORITY_OR_OTHER||Difference in Least Square Means|49.1|||||TWO_SIDED|95.0|13.37|84.83||||||||84.83|13.37|
71037842|NCT00112437|141582595|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|209.44|||||TWO_SIDED|95.0|127.14|291.73||||||||291.73|127.14|
71037843|NCT02003391|141582608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6191|||<|0.0001|ONE_SIDED|95.0||-3.8503|||ANCOVA|||||-3.8503||<0.0001
70986544|NCT00637273|141483027|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.25||0.1117|TWO_SIDED|95.0|-0.5|4.5||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in systolic blood pressure from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of systolic blood pressure as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||4.5|-0.5|0.1117
70986545|NCT00637273|141483028|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.75||0.1685|TWO_SIDED|95.0|-0.4|2.5||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in diastolic blood pressure from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of diastolic blood pressure as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||2.5|-0.4|0.1685
70986546|NCT00637273|141483028|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.75||0.1685|TWO_SIDED|95.0|-2.6|0.4||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in diastolic blood pressure from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of diastolic blood pressure as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||0.4|-2.6|0.1685
70986547|NCT00637273|141483029|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|3.31||0.2686|TWO_SIDED|95.0|-2.8|10.2||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting total cholesterol from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting total cholesterol as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||10.2|-2.8|0.2686
70986548|NCT00637273|141483029|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.8|STANDARD_ERROR_OF_MEAN|3.3||0.0814|TWO_SIDED|95.0|0.3|13.2||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting total cholesterol from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting total cholesterol as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||13.2|0.3|0.0814
70986549|NCT00637273|141483030|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.8||0.9546|TWO_SIDED|95.0|-1.6|1.5||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting HDL from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting HDL as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||1.5|-1.6|0.9546
70986550|NCT00637273|141483030|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.2|STANDARD_ERROR_OF_MEAN|0.79|<|0.0001|TWO_SIDED|95.0|2.6|5.7||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting HDL from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting HDL as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||5.7|2.6|<.0001
70986551|NCT00637273|141483031|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|1.0|STANDARD_ERROR_OF_MEAN|0.04||0.9718|TWO_SIDED|95.0|0.93|1.08||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Triglycerides data were logarithm-transformed and the change at Week 26 to baseline (Day 1), expressed as the ratio, was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting triglycerides as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||1.08|0.93|0.9718
71008821|NCT02055976|141525259|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-66.63383|STANDARD_ERROR_OF_MEAN|3.7905|<|0.001|TWO_SIDED|95.0|-74.16086|-59.10681|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-59.10681|-74.16086|<0.001
71098219|NCT00286455|141704653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.3|||<|0.001|TWO_SIDED|95.0|-35.7|-12.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-12.9|-35.7|<0.001
71008822|NCT02055976|141525259|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-71.72901|STANDARD_ERROR_OF_MEAN|3.81541|<|0.001|TWO_SIDED|95.0|-79.30431|-64.15371|||Mixed Models Analysis|||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-64.15371|-79.30431|<0.001
71008823|NCT02055976|141525259|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-43.56596|STANDARD_ERROR_OF_MEAN|3.92236|<|0.001|TWO_SIDED|95.0|-51.35899|-35.77293|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-35.77293|-51.35899|<0.001
71008824|NCT02055976|141525259|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-62.34926|STANDARD_ERROR_OF_MEAN|3.86432|<|0.001|TWO_SIDED|95.0|-70.02607|-54.67245|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-54.67245|-70.02607|<0.001
70986552|NCT00637273|141483031|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|0.89|STANDARD_ERROR_OF_MEAN|0.035||0.0062|TWO_SIDED|95.0|0.82|0.96||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Triglycerides data were logarithm-transformed and the change at Week 26 to baseline (Day 1), expressed as the ratio, was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting triglycerides as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||0.96|0.82|0.0062
70986553|NCT01505491|141483078|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|113.22|STANDARD_ERROR_OF_MEAN|1.086||0.1163|TWO_SIDED|90.0|98.752|129.812|||ANOVA||Bio-equivalence of BI 695501 vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||129.812|98.752|0.1163
70986554|NCT01505491|141483078|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|132.24|STANDARD_ERROR_OF_MEAN|1.094||0.7345|TWO_SIDED|90.0|113.984|153.412|||ANOVA||Bio-equivalence of BI 695501 vs. Humira EU was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||153.412|113.984|0.7345
70986555|NCT01505491|141483078|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|86.51|STANDARD_ERROR_OF_MEAN|1.09||0.1833|TWO_SIDED|90.0|74.974|99.83|||ANOVA||Bio-equivalence of Humira EU vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||99.830|74.974|0.1833
70986556|NCT01505491|141483079|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|109.42|STANDARD_ERROR_OF_MEAN|1.073||0.0303|TWO_SIDED|90.0|97.384|122.935|||ANOVA||Bio-equivalence of BI 695501 vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||122.935|97.384|0.0303
70986557|NCT01505491|141483079|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|128.88|STANDARD_ERROR_OF_MEAN|1.08||0.6547|TWO_SIDED|90.0|113.492|146.365|||ANOVA||Bio-equivalence of BI 695501 vs. Humira EU was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||146.365|113.492|0.6547
70986558|NCT01505491|141483079|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|86.24|STANDARD_ERROR_OF_MEAN|1.077||0.1572|TWO_SIDED|90.0|76.238|97.564|||ANOVA||Bio-equivalence of Humira EU vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||97.564|76.238|0.1572
70986559|NCT01505491|141483080|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|110.3|STANDARD_ERROR_OF_MEAN|1.063||0.0212|TWO_SIDED|90.0|99.687|122.035|||ANOVA||Bio-equivalence of BI 695501 vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||122.035|99.687|0.0212
70986560|NCT01505491|141483080|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|117.53|STANDARD_ERROR_OF_MEAN|1.066||0.17|TWO_SIDED|90.0|105.638|130.757|||ANOVA||Bio-equivalence of BI 695501 vs. Humira EU was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||130.757|105.638|0.1700
70986561|NCT01505491|141483080|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|96.53|STANDARD_ERROR_OF_MEAN|1.064||0.0016|TWO_SIDED|90.0|87.064|107.017|||ANOVA||Bio-equivalence of Humira EU vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||107.017|87.064|0.0016
70986562|NCT02759146|141483083|SUPERIORITY||Difference between least squared means|0.09||||0.72|TWO_SIDED|95.0|-0.36|0.52||Adjusted for baseline and balancing factors used in the randomization|Mixed Models Analysis||Difference between reflexology and meditative practice for weeks 1-4|Aim 1: Comparing reflexology vs meditative practice for weeks 1-4||.52|-.36|.72
70986563|NCT02759146|141483083|SUPERIORITY||Difference between least squared means|-0.15||||0.58|TWO_SIDED|95.0|-0.72|0.41|||Mixed Models Analysis||Difference between reflexology and control for weeks 1-4|Aim 1: Comparing reflexology vs control for weeks 1-4||.41|-.72|.58
70986564|NCT02759146|141483083|SUPERIORITY||Difference between least squared means|-0.24||||0.42|TWO_SIDED|95.0|-0.81|0.34|||Mixed Models Analysis||Difference between meditative practice and control for weeks 1-4|Aim 1: Comparing meditative practices vs control for weeks 1-4||.34|-.81|.42
70986565|NCT02759146|141483084|SUPERIORITY||Difference between least squared means|-0.01||||0.96|TWO_SIDED|95.0|-0.44|0.42|||Mixed Models Analysis||Difference between reflexology and meditative practice for weeks 1-4|Aim 1: Comparing reflexology vs meditative practice for weeks 1-4||0.42|-0.44|0.96
71037844|NCT02272803|141582613|SUPERIORITY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.41|1.67|||||Hazard Ratio of E-Ld to Ld. Stratified by stage of disease (International Staging System 1 - 2 vs 3)|||1.67|0.41|
71037845|NCT00902538|141582640|SUPERIORITY_OR_OTHER|||||||0.1187||95.0|||||ANCOVA|||||||0.1187
71037846|NCT00902538|141582640|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71037847|NCT00902538|141582641|SUPERIORITY_OR_OTHER|||||||0.0425||95.0|||||ANCOVA|||||||0.0425
71037848|NCT00902538|141582641|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71037849|NCT00902538|141582642|SUPERIORITY_OR_OTHER|||||||0.1939||95.0|||||Cochran-Mantel-Haenszel|||||||0.1939
70986566|NCT02759146|141483084|SUPERIORITY||Difference between least squared means|-0.2||||0.48|TWO_SIDED|95.0|-0.75|0.35|||Mixed Models Analysis||Difference between reflexology and control for weeks 1-4|Aim 1: Comparing reflexology vs control for weeks 1-4||0.35|-0.75|0.48
70986567|NCT02759146|141483084|SUPERIORITY||Difference between least squared means|-0.19||||0.52|TWO_SIDED|95.0|-0.75|0.38|||Mixed Models Analysis||Difference between meditative practice and control for weeks 1-4|Aim 1: Comparing meditative practice vs control for weeks 1-4||0.38|-0.75|0.52
70986568|NCT02759146|141483085|SUPERIORITY||Difference between least squared means|0.67||||0.68|TWO_SIDED|95.0|-2.52|3.86|||Mixed Models Analysis||Comparing reflexology to meditative practices for weeks 1-4|Aim 1: Comparing reflexology vs meditative practice for weeks 1-4||3.86|-2.52|.68
70986569|NCT02759146|141483085|SUPERIORITY||Difference between least squared means|-2.53||||0.23|TWO_SIDED|95.0|-6.64|1.58|||Mixed Models Analysis||Comparing reflexology to control for weeks 1-4|Aim 1: Comparing reflexology vs control for weeks 1-4||1.58|-6.64|.23
70986570|NCT02759146|141483085|SUPERIORITY||Difference between least squared means|-3.2||||0.14|TWO_SIDED|95.0|-7.41|1.01|||Mixed Models Analysis||Comparing meditative practice to control for weeks 1-4|Aim 1: Comparing meditative practice vs control for weeks 1-4||1.01|-7.41|0.14
70986571|NCT02759146|141483086|SUPERIORITY||Difference between least squared means|0.01||||0.98|TWO_SIDED|95.0|-0.38|0.39|||Mixed Models Analysis||Difference between reflexology and meditative practice for weeks 1-4|Aim 1: Comparing reflexology vs meditative practice for weeks 1-4||0.39|-0.38|0.98
70986572|NCT02759146|141483086|SUPERIORITY||Difference between least squared means|-0.24||||0.34|TWO_SIDED|95.0|-0.74|0.25|||Mixed Models Analysis||Comparing reflexology to control for weeks 1-4|Aim 1: Comparing reflexology vs control for weeks 1-4||0.25|-0.74|0.34
70986573|NCT02759146|141483086|SUPERIORITY||Difference between least squared means|-0.25||||0.34|TWO_SIDED|95.0|-0.76|0.26|||Mixed Models Analysis||Comparing meditative practices vs control for weeks 1-4|Aim 1: Comparing meditative practices vs control for weeks 1-4||0.26|-0.76|0.34
70986574|NCT02759146|141483087|SUPERIORITY||Difference between least squared means|0.25||||0.57|TWO_SIDED|95.0|-0.63|1.14|||Mixed Models Analysis||After the initial 4 weeks of reflexology, comparing continued reflexology to added meditative practice|Aim 2: After 4 weeks of reflexology, comparing continuing reflexology vs adding meditative practice||1.14|-.63|0.57
70986575|NCT02759146|141483087|SUPERIORITY||Least Square (LS) Mean|0.49||||0.39|TWO_SIDED|95.0|-0.64|1.63|||Mixed Models Analysis||After the initial 4 weeks of meditative practices, comparing continuing meditative practice to adding reflexology|Aim 3: After 4 weeks of meditative practice, comparing continuing with meditative practice vs. adding reflexology for weeks 5-12||1.63|-0.64|0.39
70986576|NCT02759146|141483088|SUPERIORITY||Least Square (LS) Mean|1.94||||0.67|TWO_SIDED|95.0|-10.93|7.04|||Mixed Models Analysis||After 4 weeks of reflexology, comparing continued reflexology vs adding meditative practice|Aim 2: After 4 weeks of reflexology, comparing continued reflexology vs added meditative practice for weeks 5-12||7.04|-10.93|0.67
70986577|NCT02759146|141483088|SUPERIORITY||Least Square (LS) Mean|-1.85||||0.66|TWO_SIDED|95.0|-6.59|10.29|||Mixed Models Analysis||After 4 weeks of meditative practice, comparing continued meditative practice vs adding reflexology for weeks 5-12|Aim 3: After 4 weeks of meditative practices, comparing continued meditative practice vs adding reflexology for weeks 5-12||10.29|-6.59|0.66
70986578|NCT02759146|141483089|SUPERIORITY||Difference between least squared means|-0.19||||0.62|TWO_SIDED|95.0|-0.95|0.57|||Mixed Models Analysis||After 4 weeks of reflexology, comparing continued reflexology vs added meditative practice for weeks 5-12|Aim 2: After 4 weeks of reflexology, comparing continued reflexology vs added meditative practice for weeks 5-12||0.57|-0.95|0.62
71098220|NCT00286455|141704654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.6|||<|0.001|TWO_SIDED|95.0|-34.1|-9.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.0|-34.1|<0.001
70986579|NCT02759146|141483089|SUPERIORITY||Least Square (LS) Mean|-0.04||||0.95|TWO_SIDED|95.0|-1.15|1.22|||Mixed Models Analysis||After 4 weeks of meditative practice, comparing continued meditative practice vs adding reflexology for weeks 5-12|Aim 3: After 4 weeks of meditative practice, comparing continuing meditative practice vs adding reflexology for weeks 5-12||1.22|-1.15|0.95
70986580|NCT02759146|141483090|SUPERIORITY||Difference between least squared means|-0.14||||0.77|TWO_SIDED|95.0|-1.04|0.77|||Mixed Models Analysis||After 4 weeks of reflexology, comparing continued reflexology vs added meditative practice for weeks 5-12|Aim 2: After 4 weeks of reflexology, comparing continued reflexology vs adding meditative practice for weeks 5-12||0.77|-1.04|0.77
70986581|NCT02759146|141483090|SUPERIORITY||Least Square (LS) Mean|0.22||||0.67|TWO_SIDED|95.0|-1.23|0.8|||Mixed Models Analysis||After 4 weeks of meditative practice, comparing continued meditative practice vs added reflexology for weeks 5-12|Aim 3: After 4 weeks of meditative practice, comparing continued meditative practice vs added reflexology for weeks 5-12||0.80|-1.23|0.67
70986582|NCT02759146|141483091|SUPERIORITY||Least Square (LS) Mean|0.09||||0.42|TWO_SIDED|95.0|-0.88|0.37|||Mixed Models Analysis||Comparing reflexology vs control for weeks 5-12|Aim 4: Comparing reflexology vs control for weeks 5-12||0.37|-0.88|0.42
70986583|NCT02759146|141483091|SUPERIORITY||Least Square (LS) Mean|-0.34||||0.29|TWO_SIDED|95.0|-0.98|0.29|||Mixed Models Analysis||Comparing meditative practice vs control for weeks 5-12|Aim 4: Comparing meditative practices vs control for weeks 5-12||0.29|-0.98|0.29
70986584|NCT02759146|141483092|SUPERIORITY||Least Square (LS) Mean|-0.42||||0.15|TWO_SIDED|95.0|-1.0|0.15|||Mixed Models Analysis||Comparing reflexology vs control for weeks 5-12|Aim 4: Comparing reflexology vs control for weeks 5-12||0.15|-1.00|0.15
70986585|NCT02759146|141483092|SUPERIORITY||Least Square (LS) Mean|-0.2||||0.5|TWO_SIDED|95.0|-0.8|0.39|||Mixed Models Analysis||Comparing meditative practice vs control for weeks 5-12|Aim 4: Comparing meditative practice vs control for weeks 5-12||0.39|-0.80|0.50
70986586|NCT02759146|141483093|SUPERIORITY||Least Square (LS) Mean|-0.27||||0.33|TWO_SIDED|95.0|-0.83|0.28|||Mixed Models Analysis||Comparing reflexology vs control for week 5-12|Aim 4: Comparing reflexology vs control for weeks 5-12||0.28|-0.83|0.33
70986587|NCT02759146|141483093|SUPERIORITY||Least Square (LS) Mean|-0.36||||0.22|TWO_SIDED|95.0|-0.93|0.21|||Mixed Models Analysis|||Aim 4: Comparing meditative practice vs control for weeks 5-12||0.21|-0.93|0.22
70986588|NCT02759146|141483094|SUPERIORITY||Least Square (LS) Mean|0.92||||0.17|TWO_SIDED|95.0|-8.62|1.52|||Mixed Models Analysis||Comparing reflexology vs control for weeks 5-12|Aim 4: Comparing reflexology vs control for weeks 5-12||1.52|-8.62|0.17
70986589|NCT02759146|141483094|SUPERIORITY||Least Square (LS) Mean|-4.48||||0.09|TWO_SIDED|95.0|-9.66|0.7|||Mixed Models Analysis||Comparing meditative practice vs control for weeks 5-12|Aim 4: Comparing meditative practice vs control for weeks 5-12||0.70|-9.66|0.09
70986590|NCT01397071|141483095|OTHER||Mean Difference (Final Values)|2.2||||0.052|TWO_SIDED|95.0|||||t-test, 2 sided|||Comparison of change in PAT measurements was made to beef alone vs. beef with avocado 2 hours post-ingestion||||0.052
70986591|NCT01397071|141483096|OTHER||% of baseline|0.58||||0.03|TWO_SIDED|||||Significance is defined as p\<0.05.|t-test, 2 sided|||Comparison was made to beef patty alone vs. beef patty with avocado added 3 hours post-ingestion.||||0.03
70986592|NCT03408873|141483107|OTHER||Mean Difference (Final Values)|-31.4|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 29 participants with screen data only 11 had Week 24 data. Statistical Analysis was conducted for 11 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
70986593|NCT03408873|141483107|OTHER||Mean Difference (Final Values)|-11.7||||0.12|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between baseline \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 28 participants with baseline data only 11 had Week 24 data. Statistical Analysis was conducted for 11 participants with data at the 2 timepoints. The mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||0.12
70986594|NCT03408873|141483108|OTHER||Mean Difference (Final Values)|-19.6||||0.0599|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 29 participants with screen data only 11 had Week 24 data. Statistical Analysis was conducted for 11 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||0.0599
70986595|NCT03408873|141483108|OTHER||Mean Difference (Final Values)|-3.2||||0.63|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between baseline \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 28 participants with baseline data only 11 had Week 24 data. Statistical Analysis was conducted for 11 participants with data at the 2 timepoints. The mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||0.63
71037850|NCT00902538|141582642|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
71037851|NCT00902538|141582643|SUPERIORITY_OR_OTHER|||||||0.0009||95.0|||||ANCOVA|||||||0.0009
71037852|NCT00902538|141582643|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71037853|NCT00902538|141582644|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANCOVA|||||||0.0001
71037854|NCT00902538|141582644|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71037855|NCT00902538|141582645|SUPERIORITY_OR_OTHER|||||||0.1611||95.0|||||ANCOVA|||||||0.1611
71037856|NCT00902538|141582646|SUPERIORITY_OR_OTHER|||||||0.0451||95.0|||||ANCOVA|||||||0.0451
71037857|NCT00902538|141582647|SUPERIORITY_OR_OTHER|||||||0.0412||95.0|||||ANCOVA|||||||0.0412
71037858|NCT00902538|141582648|SUPERIORITY_OR_OTHER|||||||0.0253||95.0|||||ANCOVA|||||||0.0253
71037859|NCT00902538|141582649|SUPERIORITY_OR_OTHER|||||||0.0063||95.0|||||ANCOVA|||||||0.0063
71037860|NCT00926887|141582652|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
71037861|NCT00926887|141582655|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|t=-2.711; df=102; p\<0.01||||||<0.01
71037862|NCT00926887|141582659|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|df=102, t=-3.44||||||<0.001
71037863|NCT00834964|141582720|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|97.0||||||90.0|92.72|101.49|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.49|92.72|
71037864|NCT00834964|141582721|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|99.7||||||90.0|94.74|104.92|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.92|94.74|
71037865|NCT00834964|141582722|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.6||||||90.0|93.46|104.02|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.02|93.46|
71037866|NCT00834964|141582723|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.29||||||90.0|91.96|100.82|||||Metabolite results not subjected to bioequivalence criteria; results are presented for informational purposes only.|||100.82|91.96|
71037867|NCT00834964|141582724|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|104.1||||||90.0|100.08|108.29|||||Metaboite results not subjected to bioequivalence criteria, results are presented for informational purposes only.|||108.29|100.08|
70986596|NCT03408873|141483110|OTHER||Mean Difference (Final Values)|-10.7|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between baseline \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with baseline data only 19 had Week 24 data. Statistical Analysis was conducted for 19 participants with data at the 2 timepoints. The mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
70986597|NCT03408873|141483111|OTHER||Mean Difference (Final Values)|-8.4|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 19 had Week 24 data. Statistical Analysis was conducted for 19 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
70986598|NCT03408873|141483111|OTHER||Mean Difference (Final Values)|-5.8|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared for the primary and secondary outcomes across two sets of time-points: 1) difference between screen and week 24, and 2) between baseline and week 24. A non-parametric Wilcoxon signed-rank test compared these repeated measurements (matched on participant) between these time-points to determine whether the population medians differed.||||<0.001
70986599|NCT03408873|141483112|OTHER||Mean Difference (Final Values)|-16.6|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
70986600|NCT03408873|141483112|OTHER|We compared the repeated measure outcome across 2 time-points (difference between baseline \& week 24) to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with baseline data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. The mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.|Mean Difference (Final Values)|-8.1||||0.003|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared for the primary and secondary outcomes across two sets of time-points: 1) difference between screen and week 24, and 2) between baseline and week 24. A non-parametric Wilcoxon signed-rank test compared these repeated measurements (matched on participant) between these time-points to determine whether the population medians differed.||||0.003
70986601|NCT03408873|141483113|OTHER|We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data.|Mean Difference (Final Values)|-1.8|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
70986602|NCT03408873|141483113|OTHER||Mean Difference (Final Values)|-1.3|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared for the primary and secondary outcomes across two time-points: difference between baseline and week 24. A non-parametric Wilcoxon signed-rank test compared these repeated measurements (matched on participant with complete data) between these time-points to determine whether the population medians differed.||||<0.001
70986603|NCT03408873|141483114|OTHER||Mean Difference (Final Values)|0.8||||0.0566|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared for the primary and secondary outcomes across two sets of time-points: 1) difference between screen and week 24, and 2) between baseline and week 24. A non-parametric Wilcoxon signed-rank test compared these repeated measurements (matched on participant) between these time-points to determine whether the population medians differed.||||0.0566
70986604|NCT03408873|141483115|OTHER||Mean Difference (Final Values)|-3.4|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared for the primary and secondary outcomes across two time-points: difference between screen and week 24. A non-parametric Wilcoxon signed-rank test compared these repeated measurements (matched on participant with complete data) between these time-points to determine whether the population medians differed.||||<0.001
70986605|NCT03408873|141483116|OTHER||Mean Difference (Final Values)|17.7|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
70986606|NCT03408873|141483117|OTHER||Mean Difference (Final Values)|16.9|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between baseline \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with baseline data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. The mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
70986607|NCT03408873|141483118|OTHER||Mean Difference (Final Values)|14.7|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 29 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
71098221|NCT00286455|141704654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.8|||<|0.001|TWO_SIDED|95.0|-40.4|-15.1||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-15.1|-40.4|<0.001
70986608|NCT03408873|141483119|OTHER||Mean Difference (Final Values)|19.2|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
70986609|NCT03408873|141483120|OTHER||Mean Difference (Final Values)|-0.5||||0.73|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||0.73
70986610|NCT03408873|141483121|OTHER||Mean Difference (Final Values)|-10.7||||0.02|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||0.02
70986611|NCT01600131|141483122|SUPERIORITY||Slope|-0.68|STANDARD_ERROR_OF_MEAN|1.72||0.693|TWO_SIDED|||||a priori \<.05 threshold|Mixed Models Analysis||group X time interaction|||||0.693
70986612|NCT01600131|141483123|SUPERIORITY||Slope|-2.17|STANDARD_ERROR_OF_MEAN|2.07||0.693|TWO_SIDED|||||a priori \<.05 threshold|Mixed Models Analysis||group x time interaction|||||0.693
70986613|NCT01600131|141483124|SUPERIORITY||Slope|-2.08|STANDARD_ERROR_OF_MEAN|1.08||0.055|TWO_SIDED||||||Mixed Models Analysis||group X time interaction|||||0.055
70986614|NCT01600131|141483125|SUPERIORITY||Slope|-1.08|STANDARD_ERROR_OF_MEAN|1.15||0.346|TWO_SIDED||||||Mixed Models Analysis||group X time interaction|||||0.346
70986615|NCT01600131|141483127|SUPERIORITY||Slope|-0.72|STANDARD_ERROR_OF_MEAN|1.79||0.688|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.688
70986616|NCT01600131|141483128|SUPERIORITY||Slope|-1.52|STANDARD_ERROR_OF_MEAN|1.87||0.418|TWO_SIDED|||||a priori \<.05|Mixed Models Analysis||group X time interaction|||||0.418
70986617|NCT01600131|141483129|SUPERIORITY||Slope|-1.94|STANDARD_ERROR_OF_MEAN|1.45||0.18|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.180
70986618|NCT01600131|141483130|SUPERIORITY||Slope|-0.63|STANDARD_ERROR_OF_MEAN|0.65||0.332|TWO_SIDED||||||Mixed Models Analysis||group X time interaction|||||0.332
71098222|NCT00286455|141704655|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.569||||0.165|TWO_SIDED|95.0|0.257|1.262|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||1.262|0.257|0.165
71098223|NCT00286455|141704655|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32||||0.008|TWO_SIDED|95.0|0.138|0.739|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.739|0.138|0.008
70986619|NCT01600131|141483131|SUPERIORITY||Slope|-0.56|STANDARD_ERROR_OF_MEAN|0.56||0.318|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.318
70986620|NCT01600131|141483132|SUPERIORITY||Slope|2.33|STANDARD_ERROR_OF_MEAN|1.31||0.077|TWO_SIDED|||||a priori \<.05|Mixed Models Analysis||group X time interaction|||||0.077
70986621|NCT01600131|141483133|SUPERIORITY||Slope|1.5|STANDARD_ERROR_OF_MEAN|1.46||0.305|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.305
70986622|NCT01600131|141483136|SUPERIORITY||Slope|-0.62|STANDARD_ERROR_OF_MEAN|0.94||0.514|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.514
70986623|NCT01600131|141483137|SUPERIORITY||Slope|-1.61|STANDARD_ERROR_OF_MEAN|0.94||0.09|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.090
70986624|NCT01600131|141483138|SUPERIORITY||Slope|6.71|STANDARD_ERROR_OF_MEAN|2.57||0.009|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.009
70986625|NCT01600131|141483139|SUPERIORITY||Slope|4.29|STANDARD_ERROR_OF_MEAN|3.53||0.225|TWO_SIDED||||||Mixed Models Analysis||group X time interaction|||||0.225
70986626|NCT01600131|141483140|SUPERIORITY||Slope|3.75|STANDARD_ERROR_OF_MEAN|4.89||0.443|TWO_SIDED|||||a priori \<.05 threshold|Mixed Models Analysis||group X time interaction|||||0.443
70986627|NCT01600131|141483141|SUPERIORITY||Slope|7.39|STANDARD_ERROR_OF_MEAN|5.23||0.158|TWO_SIDED||||||Mixed Models Analysis||group x time interaction|||||0.158
70986628|NCT01600131|141483142|SUPERIORITY||Slope|7.28|STANDARD_ERROR_OF_MEAN|3.64||0.046|TWO_SIDED|||||a priori \<.05 threshold|Mixed Models Analysis||group X time interaction|||||0.046
70986629|NCT01600131|141483143|SUPERIORITY||Slope|5.54|STANDARD_ERROR_OF_MEAN|3.83||0.149|TWO_SIDED||||||Mixed Models Analysis||group X time interaction|||||0.149
70986630|NCT01600131|141483144|SUPERIORITY||Slope|4.16|STANDARD_ERROR_OF_MEAN|1.95||0.034|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.034
70986631|NCT01600131|141483145|SUPERIORITY||Slope|-0.3|STANDARD_ERROR_OF_MEAN|1.52||0.846|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.846
70986632|NCT01600131|141483146|SUPERIORITY||Slope|1.67|STANDARD_ERROR_OF_MEAN|2.17||0.0442|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||.0442
70986633|NCT01600131|141483147|SUPERIORITY||Slope|1.98|STANDARD_ERROR_OF_MEAN|1.88||0.293|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.293
70986634|NCT02214186|141483190|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Mann-Whitney followed by Friedman test||||||<0.05
70986635|NCT02214186|141483191|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Mann-Whitney followed by Friedman test||||||<0.05
70986636|NCT02214186|141483192|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|ANOVA for repeated measures||||||<0.05
70986637|NCT02214186|141483193|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Mann-Whitney followed by Friedman test||||||<0.05
70986638|NCT02214186|141483194|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|ANOVA for repeated measures.||||||>0.05
70986639|NCT02214186|141483195|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Mann-Whitney followed by Friedman test||||||<0.05
71037868|NCT00834964|141582725|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.52||||||90.0|97.3|103.84|||||Metabolite results were not subjected to bioequivalence criteria, results are presented for informational purposes only.|||103.84|97.30|
71037869|NCT00385736|141582753|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||The primary endpoint analysis was carried out in hierarchical order (as presented) to handle the multiplicity issues induced by the two adalimumab groups being compared to placebo and to control the overall alpha level of 0.05.|Chi-squared|||||||0.031
71037870|NCT00385736|141582753|SUPERIORITY_OR_OTHER|||||||0.833||95.0||||The primary endpoint analysis was carried out in hierarchical order (as presented) to handle the multiplicity issues induced by the two adalimumab groups being compared to placebo and to control the overall alpha level of 0.05.|Chi-squared|||||||0.833
71098224|NCT00286455|141704656|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.194||||0.001|TWO_SIDED|95.0|0.073|0.516|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.516|0.073|0.001
71098225|NCT00286455|141704656|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.145|||<|0.001|TWO_SIDED|95.0|0.052|0.405|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.405|0.052|<0.001
71098226|NCT00286455|141704657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.6||||0.056|TWO_SIDED|95.0|-15.3|0.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.2|-15.3|0.056
71098227|NCT00286455|141704657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.3|||<|0.001|TWO_SIDED|95.0|-21.1|-5.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-5.5|-21.1|<0.001
71098228|NCT00286455|141704658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.85|TWO_SIDED|95.0|-7.8|9.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||9.4|-7.8|0.850
71098229|NCT00286455|141704658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.571|TWO_SIDED|95.0|-6.2|11.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||11.2|-6.2|0.571
71098230|NCT00286455|141704659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.917|TWO_SIDED|95.0|-7.8|7.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.0|-7.8|0.917
70986640|NCT02214186|141483196|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70986641|NCT02214186|141483197|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|ANOVA for repeated measures.||||||<0.05
70986642|NCT02214186|141483198|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70986643|NCT02086565|141483278|SUPERIORITY||Group differences in expected 12 month c|-0.21|||||TWO_SIDED|95.0|-0.56|0.15||||||||0.15|-0.56|
70986644|NCT02086565|141483279|SUPERIORITY||Group differences in expected 12 month c|0.19|||||TWO_SIDED|95.0|-0.27|0.68|||||Estimation parameter: Other. Group differences in expected 12 month change from baseline|||0.68|-0.27|
70986645|NCT02086565|141483280|SUPERIORITY||Group differences in expected 12 month c|-0.6|||||TWO_SIDED|95.0|-2.21|0.97||||||||0.97|-2.21|
70986646|NCT02086565|141483281|SUPERIORITY||Group differences in expected 12 month c|-0.53|||||TWO_SIDED|95.0|-1.08|-0.24||||||||-0.24|-1.08|
70986647|NCT02086565|141483282|SUPERIORITY||Group differences in expected 12 month c|-0.09|||||TWO_SIDED|95.0|-0.24|0.06||||||||0.06|-0.24|
71037871|NCT00385736|141582754|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.107
71037872|NCT00385736|141582755|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.382
71037873|NCT00385736|141582756|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.038
71037874|NCT00385736|141582757|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.035
70986648|NCT02116972|141483283|SUPERIORITY||Mean Difference (Final Values)|-0.58||||0.0821|TWO_SIDED|95.0|-1.22|0.07|||Logitudinal mixed effects model|||The step-down testing procedure to control for multiplicity would be voided if the primary endpoint is not met and analyses proceeded for exploratory purposes.||0.07|-1.22|0.0821
70986649|NCT00325442|141483296|SUPERIORITY_OR_OTHER||Hodges-Lehmann|11.0||||0.072|TWO_SIDED|95.0|0.0|22.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||22|0|0.072
70986650|NCT00325442|141483297|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|0.0||||0.062|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||Change in Borg dyspnea score from Baseline to Week 16||0.0|-1.0|0.062
70986651|NCT00325442|141483298|SUPERIORITY_OR_OTHER|||||||0.491||95.0|||||Fisher Exact|||||||0.491
70986652|NCT00325442|141483299|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|0.0||||0.011|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon sum-rank test|||Change in dyspnea-fatigue index from Baseline to Week 16||1.0|0.0|0.011
70986653|NCT00325442|141483301|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|13.0||||0.015|TWO_SIDED|95.0|3.0|23.0|||ANCOVA|||Change in 6MWD from Baseline to Week 12||23.0|3.0|0.015
70986654|NCT00325442|141483302|SUPERIORITY_OR_OTHER||Hodges-Lehmann|9.0||||0.051|TWO_SIDED|95.0|0.0|18.0|||ANCOVA|||Change in 6MWD from Baseline to Week 8||18.0|0.0|0.051
70986655|NCT00325442|141483303|SUPERIORITY_OR_OTHER||Hodges-Lehmann ( H-L)|4.0||||0.238|TWO_SIDED|95.0|-2.4|12.0|||ANCOVA|||Change in 6MWD from Baseline to Week 4||12.0|-2.4|0.238
71037875|NCT00385736|141582758|SUPERIORITY_OR_OTHER|||||||0.08||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.080
70986656|NCT00325442|141483304|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|24.0||||0.121|TWO_SIDED|95.0|0.0|45.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||45|0|0.121
71037876|NCT00385736|141582759|SUPERIORITY_OR_OTHER|||||||0.264||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.264
70986657|NCT00325442|141483305|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|15.0||||0.069|TWO_SIDED|95.0|-7.0|41.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||41|-7|0.069
70986658|NCT00325442|141483306|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|4.0||||0.889|TWO_SIDED|95.0|-15.0|24.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||24|-15|0.889
70986659|NCT00325442|141483307|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|0.0||||0.966|TWO_SIDED|95.0|-23.0|24.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||24|-23|0.966
70986660|NCT00325442|141483309|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|5.0||||0.853|TWO_SIDED|95.0|-16.0|28.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||28|-16|0.853
70986661|NCT00325442|141483310|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|7.0||||0.327|TWO_SIDED|95.0|-7.0|21.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||21|-7|0.327
70986662|NCT00325442|141483311|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|29.5||||0.085|TWO_SIDED|95.0|1.0|73.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||73|1|0.085
70986663|NCT00325442|141483312|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|5.0||||0.615|TWO_SIDED|95.0|-12.0|24.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||24|-12|0.615
70986664|NCT00325442|141483313|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|17.0||||0.23|TWO_SIDED|95.0|-6.0|40.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||40|-6|0.230
70986665|NCT00325442|141483314|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|10.0||||0.209|TWO_SIDED|95.0|-6.0|28.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||28|-6|0.209
70986666|NCT02986958|141483439|OTHER|We used generalized estimating equations with an exchangeable correlation structure to assess the direction, magnitude, and statistical significance of between-group differences. Regression models included treatment assignment and patient-level covariates (patient age, gender, and MMSE score) that were postulated as affecting communication outcomes. Statistical tests were 2-sided with a significance level of 0.05. Analyses were performed in SAS statistical software, version 9.4 (SAS, Cary, NC).|Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.08||0.046|TWO_SIDED||||||t-test, 2 sided|||||||0.046
70986667|NCT01605396|141483457|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.565|TWO_SIDED|80.0|0.81|1.72|||Regression, Cox|||Hazard ratio (HR) and p-value for treatment difference based on Cox regression model with Efron tie handling for treatment comparison (Ridaforolimus + Dalotuzumab + Exemestane arm versus Ridaforolimus + Exemestane arm).||1.72|0.81|0.565
70986668|NCT01605396|141483459|OTHER||Difference of Percentages|-10.0||||0.267|TWO_SIDED|95.0|-27.8|8.0|||Miettinen and Nurminen's Method|||Miettinen and Nurminen's method was used to compare ORR between the two treatment arms (Ridaforolimus + Dalotuzumab + Exemestane arm versus Ridaforolimus + Exemestane arm), and to calculate a p-value and 95% confidence interval (CI) for the difference in response rates.||8.0|-27.8|0.267
70986669|NCT01605396|141483460|OTHER||Hazard Ratio (HR)|1.38||||0.562|TWO_SIDED|95.0|0.46|4.13|||Regression, Cox|||HR and p-value for treatment difference based on Cox regression model with Efron tie handling for treatment comparison (Ridaforolimus + Dalotuzumab + Exemestane arm versus Ridaforolimus + Exemestane arm).||4.13|0.46|0.562
70986670|NCT02795988|141483463|SUPERIORITY||Cox proportional hazard regression model|0.603||||0.078|TWO_SIDED|80.0|0.38|0.957||1-sided p-value was calculated from Log-rank test stratified by factor tumor stage which used for randomization at screening.|Log Rank|||||0.957|0.380|0.078
70986671|NCT00390780|141483476|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Expected cure rate: 70% Type I error: 2.5% Type II error: 5%"|comparison of proportion clinical cure|0.15|||>|0.025|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025|one-sided test|||"Analyses for ITT and PP populations:~H0: clinical cure rate for miconazole Lauriad minus clinical cure rate for clotrimazole troches is less than or equal to -0.15 H1: clinical cure rate for miconazole Lauriad minus clinical cure rate for Mycelex troches is greater than -0.15"|||-0.15|>0.025
70986672|NCT00390780|141483477|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Expected cure rate: 70% Type I error: 2.5% Type II error: 5%"|comparison of proportion clinical cure|0.15|||>|0.025|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|one-sided noninferiority test|||"Analysis for ITT and PP populations:~H0: clinical cure rate for miconazole Lauriad minus clinical cure rate for clotrimazole troches is less than or equal to -0.15 H1: clinical cure rate for miconazole Lauriad minus clinical cure rate for Mycelex troches is greater than -0.15"|||-0.15|>0.025
71037877|NCT00385736|141582760|SUPERIORITY_OR_OTHER|||||||0.526||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.526
71037878|NCT00385736|141582761|SUPERIORITY_OR_OTHER|||||||0.506||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.506
71037879|NCT00385736|141582762|SUPERIORITY_OR_OTHER|||||||0.264||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.264
70986673|NCT00390780|141483478|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|compare proportion of clinical success|0.15||||0.0974|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Cochran-Mantel-Haenszel|||"Analysis for ITT population:~H0: clinical success rate for miconazole Lauriad minus clinical success rate for clotrimazole troches is less than or equal to -0.15 H1: clinical success rate for miconazole Lauriad minus clinical success rate for Mycelex troches is greater than -0.15"|||-0.15|0.0974
70986674|NCT00390780|141483478|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|Compare proportion of clinical success|0.15||||0.1115|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Cochran-Mantel-Haenszel|||"Analysis for PP population:~H0: clinical success rate for miconazole Lauriad minus clinical success rate for clotrimazole troches is less than or equal to -0.15 H1: clinical success rate for miconazole Lauriad minus clinical success rate for Mycelex troches is greater than -0.15"|||-0.15|0.1115
70986675|NCT00390780|141483479|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|compare proportion of clinical success|0.15||||0.8787|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Cochran-Mantel-Haenszel|||"Analysis for ITT population:~H0: clinical success rate for miconazole Lauriad minus clinical success rate for clotrimazole troches is less than or equal to -0.15 H1: clinical success rate for miconazole Lauriad minus clinical success rate for Mycelex troches is greater than -0.15"|||-0.15|0.8787
70986676|NCT00390780|141483479|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|compare proportion of clinical success|0.15||||0.7969|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Cochran-Mantel-Haenszel|||"Analysis for PP population:~H0: clinical success rate for miconazole Lauriad minus clinical success rate for clotrimazole troches is less than or equal to -0.15 H1: clinical success rate for miconazole Lauriad minus clinical success rate for Mycelex troches is greater than -0.15"|||-0.15|0.7969
70986677|NCT00390780|141483480|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|compare proportion of partial response|0.15||||0.882|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Cochran-Mantel-Haenszel|||"Analysis for ITT population:~H0: partial response rate for miconazole Lauriad minus partial response rate for clotrimazole troches is less than or equal to -0.15 H1: partial response rate for miconazole Lauriad minus partial response rate for Mycelex troches is greater than -0.15"|||-0.15|0.8820
71037880|NCT00385736|141582763|SUPERIORITY_OR_OTHER|||||||0.797||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.797
71037881|NCT00385736|141582764|SUPERIORITY_OR_OTHER|||||||0.614||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.614
70986678|NCT00390780|141483480|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|compare proportion of partial response|0.15||||0.9033|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Cochran-Mantel-Haenszel|||"Analysis for PP population:~H0: partial response rate for miconazole Lauriad minus partial response rate for clotrimazole troches is less than or equal to -0.15 H1: partial response rate for miconazole Lauriad minus partial response rate for Mycelex troches is greater than -0.15"|||-0.15|0.9033
71037882|NCT00385736|141582765|SUPERIORITY_OR_OTHER|||||||0.532||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.532
71098231|NCT00286455|141704659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.133|TWO_SIDED|95.0|-13.2|1.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.7|-13.2|0.133
71098232|NCT00286455|141704660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9||||0.348|TWO_SIDED|95.0|-12.1|4.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.3|-12.1|0.348
71037883|NCT01662960|141582779|SUPERIORITY|Test for the superiority of Mirror therapy over Divider therapy.|Slope|2.2||||0.443|TWO_SIDED|||||ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.|ANCOVA|||||||.443
71037884|NCT01662960|141582780|SUPERIORITY|Test for the superiority of Mirror therapy over Divider therapy.|Slope|0.4||||0.8|TWO_SIDED|||||ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.|ANCOVA|||||||.80
71037885|NCT01662960|141582781|SUPERIORITY|Test for the superiority of Mirror therapy over Divider therapy.|Slope|-0.002||||0.93|TWO_SIDED|||||ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.|ANCOVA|||||||.93
70986679|NCT00390780|141483481|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority statistical analysis for ITT population.|difference in proportion mycologic cure|0.15||||0.5816|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Chi-squared||||||-0.15|0.5816
70986680|NCT00390780|141483481|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority statistical analysis for PP population|difference in proportion mycologic cure|0.15||||0.4439|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Chi-squared||||||-0.15|0.4439
70986681|NCT00390780|141483482|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority statistical analysis for ITT population.|difference in proportion relapsed|0.15||||0.833|ONE_SIDED|95.0|-0.15|||Significance level is \<0.025.|Chi-squared||||||-0.15|0.8330
70986682|NCT00390780|141483482|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority statistical analysis for PP population.|difference in proportion relapsed|0.15||||0.9738|ONE_SIDED|95.0|-0.15|||Significance level is \<0.025.|Chi-squared||||||-0.15|0.9738
70986683|NCT00390780|141483487|SUPERIORITY_OR_OTHER|||||||0.186||95.0|||||Wilcoxon (Mann-Whitney)|||Analysis for Clotrimazole minimum inhibitory concentration (MIC) between treatment groups||||0.1860
70986684|NCT00390780|141483487|SUPERIORITY_OR_OTHER|||||||0.9564||95.0|||||Wilcoxon (Mann-Whitney)|||Analysis for Miconazole minimum inhibitory concentration (MIC) between treatment groups||||0.9564
70986685|NCT00109733|141483507|SUPERIORITY_OR_OTHER|||||||0.177|||||||ANOVA|||"The null hypothesis (% change in trunk fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in trunk fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.177
70986686|NCT00109733|141483507|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANOVA|||"The null hypothesis (% change in trunk fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in trunk fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.004
70986687|NCT00109733|141483508|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANOVA|||"The null hypothesis (% change in lean body mass (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in lean body mass (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.004
70986688|NCT00109733|141483508|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||"The null hypothesis (% change in lean body mass (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in lean body mass (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||<0.001
70986689|NCT00109733|141483509|SUPERIORITY_OR_OTHER|||||||0.653|||||||ANOVA|||"The null hypothesis (% change in total body fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in total body fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.653
70986690|NCT00109733|141483509|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANOVA|||"The null hypothesis (% change in total body fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in total body fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.002
70986691|NCT00109733|141483510|SUPERIORITY_OR_OTHER|||||||0.755|||||||ANOVA|||"The null hypothesis (% change in limb fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in limb fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.755
70986692|NCT00109733|141483510|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||"The null hypothesis (% change in limb fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in limb fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||<0.001
70986693|NCT00109733|141483511|SUPERIORITY_OR_OTHER|||||||0.041|||||||ANOVA|||"The null hypothesis (% change in trunk to limb fat ratio from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in trunk to limb fat ratio from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.041
70986694|NCT00109733|141483511|SUPERIORITY_OR_OTHER|||||||0.044|||||||ANOVA|||"The null hypothesis (% change in trunk to limb fat ratio from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in trunk to limb fat ratio from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.044
70986695|NCT02433288|141483521|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Log Rank|||||||0.0019
70986696|NCT02433288|141483522|SUPERIORITY_OR_OTHER|||||||0.0017|||||||Chi-squared|||||||0.0017
70986697|NCT02433288|141483523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.24|STANDARD_ERROR_OF_MEAN|3.39|<|0.0001|TWO_SIDED|95.0|-26.91|-13.57|||t-test, 2 sided|||||-13.57|-26.91|<0.0001
70986698|NCT02433288|141483524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|1.6||0.3939|TWO_SIDED|95.0|-4.56|1.8|||t-test, 2 sided|||||1.80|-4.56|0.3939
70986699|NCT02433288|141483525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|1.99||0.7514|TWO_SIDED|95.0|-3.27|4.53|||ANCOVA|linear model including terms for randomized group and baseline LDL-C||||4.53|-3.27|0.7514
70986700|NCT00367640|141483526|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||ANCOVA of the average RTSS, with treatment and pooled sites as factors, and retrospective RTSS, asthma and sensitised status as covariates.|ANCOVA|||A step-down approach is performed to address the multiplicity issue.||||0.0006
70986701|NCT00367640|141483526|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||ANCOVA of the average RTSS, with treatment and pooled sites as factors, and retrospective RTSS, asthma and sensitised status as covariates.|ANCOVA|||A step-down approach is performed to address the multiplicity issue.||||0.0001
70986702|NCT00367640|141483526|SUPERIORITY_OR_OTHER|||||||0.4606|TWO_SIDED|||||ANCOVA of the average RTSS, with treatment and pooled sites as factors, and retrospective RTSS, asthma and sensitised status as covariates.|ANCOVA|||A step-down approach is performed to address the multiplicity issue.||||0.4606
70986703|NCT00406315|141483529|SUPERIORITY_OR_OTHER_LEGACY||One-sided upper confidence limit|-0.53|||||ONE_SIDED|95.0|||||||A one-sided 95% confidence interval (CI) was constructed for the mean weight change from baseline to infer whether there was a significant decrease in weight.|Week 16.||||
70986704|NCT00406315|141483529|SUPERIORITY_OR_OTHER_LEGACY||One-sided upper confidence limit|-0.33|||||ONE_SIDED|95.0|||||||A one-sided 95% CI was constructed for the mean weight change from baseline to infer whether there was a significant decrease in weight.|Week 16 LOCF. Based on past information, the standard deviation of the mean weight difference was expected to be 2.2. The sample size of the study was estimated so that the one-sided CI of the mean weight decrease has a certain width. To obtain a one-sided CI with a width of 0.27 kg, a sample size of 180 subjects was needed. In other words, we were 95% certain that the true mean weight decrease was in an interval starting from the observed weight decrease and extending 0.27 kg unit above it.||||
70986705|NCT00406315|141483530|SUPERIORITY_OR_OTHER_LEGACY||Mean|-3.0|||||TWO_SIDED|95.0|-8.48|2.41||||||Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||2.41|-8.48|
70986706|NCT00406315|141483531|SUPERIORITY_OR_OTHER_LEGACY||Mean|-0.2|||||TWO_SIDED|95.0|-1.82|1.44||||||HDL. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||1.44|-1.82|
70986707|NCT00406315|141483531|SUPERIORITY_OR_OTHER_LEGACY||Mean|-2.5|||||TWO_SIDED|95.0|-7.07|2.09||||||LDL. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||2.09|-7.07|
70986708|NCT00406315|141483531|SUPERIORITY_OR_OTHER_LEGACY||Mean|-1.6|||||TWO_SIDED|95.0|-16.44|13.15||||||Triglycerides. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||13.15|-16.44|
70986709|NCT00406315|141483532|SUPERIORITY_OR_OTHER_LEGACY||Mean|0.1|||||TWO_SIDED|95.0|-0.02|0.14||||||The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||0.14|-0.02|
70986710|NCT00406315|141483533|SUPERIORITY_OR_OTHER_LEGACY||Mean|3.0|||||TWO_SIDED|95.0|-0.09|6.15||||||The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||6.15|-0.09|
70986711|NCT00406315|141483534|SUPERIORITY_OR_OTHER_LEGACY||Mean|134.8|||||TWO_SIDED|95.0|-20.43|289.98||||||The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||289.98|-20.43|
70986712|NCT00406315|141483535|SUPERIORITY_OR_OTHER_LEGACY||Mean|-2.9|||||TWO_SIDED|95.0|-5.93|0.11||||||Waist. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||0.11|-5.93|
70986713|NCT00406315|141483535|SUPERIORITY_OR_OTHER_LEGACY||Mean|-3.0|||||TWO_SIDED|95.0|-6.2|0.1||||||Hip. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||0.10|-6.20|
70986714|NCT00406315|141483536|SUPERIORITY_OR_OTHER_LEGACY||Mean|0.05|||||TWO_SIDED|95.0|-0.32|0.42||||||Total Score. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||0.42|-0.32|
70986715|NCT00406315|141483536|SUPERIORITY_OR_OTHER_LEGACY||Mean|0.03|||||TWO_SIDED|95.0|-0.05|0.11||||||Global Severity Score. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||0.11|-0.05|
70986716|NCT00406315|141483536|SUPERIORITY_OR_OTHER_LEGACY||Mean|0.01|||||TWO_SIDED|95.0|-0.06|0.07||||||Global Incapacitation Score. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||0.07|-0.06|
70986717|NCT00406315|141483537|SUPERIORITY_OR_OTHER_LEGACY||Mean|-10.22|||||TWO_SIDED|95.0|-12.7|-7.75||||||Total Score, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-7.75|-12.70|
70986718|NCT00406315|141483537|SUPERIORITY_OR_OTHER_LEGACY||Mean|-6.61|||||TWO_SIDED|95.0|-8.59|-4.63||||||Total Score, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-4.63|-8.59|
70986719|NCT00406315|141483537|SUPERIORITY_OR_OTHER_LEGACY||Mean|-3.3|||||TWO_SIDED|95.0|-4.07|-2.53||||||Positive Subscale Score, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-2.53|-4.07|
70986720|NCT00406315|141483537|SUPERIORITY_OR_OTHER_LEGACY||Mean|-2.43|||||TWO_SIDED|95.0|-3.03|-1.83||||||Positive Subscale Score, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-1.83|-3.03|
70986721|NCT00406315|141483537|SUPERIORITY_OR_OTHER_LEGACY||Mean|-1.67|||||TWO_SIDED|95.0|-2.36|-0.99||||||Negative Subscale Score, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.99|-2.36|
70986722|NCT00406315|141483537|SUPERIORITY_OR_OTHER_LEGACY||Mean|-0.92|||||TWO_SIDED|95.0|-1.48|-0.35||||||Negative Subscale Score, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.35|-1.48|
70986723|NCT00406315|141483538|SUPERIORITY_OR_OTHER_LEGACY||Mean|-0.76|||||TWO_SIDED|95.0|-0.9|-0.61||||||Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.61|-0.90|
70986724|NCT00406315|141483538|SUPERIORITY_OR_OTHER_LEGACY||Mean|-0.47|||||TWO_SIDED|95.0|-0.58|-0.36||||||Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.36|-0.58|
70986725|NCT00406315|141483539|SUPERIORITY_OR_OTHER_LEGACY||Mean|2.7|||||TWO_SIDED|95.0|2.52|2.88||||||Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||2.88|2.52|
70986726|NCT00406315|141483539|SUPERIORITY_OR_OTHER_LEGACY||Mean|3.2|||||TWO_SIDED|95.0|3.02|3.34||||||Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||3.34|3.02|
70986727|NCT00406315|141483540|SUPERIORITY_OR_OTHER_LEGACY||Mean|-2.55|||||TWO_SIDED|95.0|-3.27|-1.83||||||Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-1.83|-3.27|
70986728|NCT00406315|141483540|SUPERIORITY_OR_OTHER_LEGACY||Mean|-1.58|||||TWO_SIDED|95.0|-2.16|-0.99||||||Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.99|-2.16|
70986729|NCT00406315|141483541|SUPERIORITY_OR_OTHER_LEGACY||Mean|-4.61|||||TWO_SIDED|95.0|-5.95|-3.26||||||Total Score, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-3.26|-5.95|
71037886|NCT01662960|141582783|SUPERIORITY|Test for the superiority of Mirror therapy over Divider therapy.|Slope|10.7||||0.28|TWO_SIDED|||||ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.|ANCOVA|||||||.28
71037887|NCT01662960|141582784|SUPERIORITY|Test for the superiority of Mirror therapy over Divider therapy.|Slope|-0.36||||0.86|TWO_SIDED|||||ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.|ANCOVA|||||||.86
71037888|NCT02727192|141582787|SUPERIORITY||Mean Difference (Net)|-0.6||||0.52|TWO_SIDED|95.0|-2.6|1.3||A two-sided significance level of 5% was considered to indicate statistical significance.|Regression, Linear|||||1.3|-2.6|0.520
71037889|NCT02727192|141582788|SUPERIORITY||Mean Difference (Net)|-0.9||||0.44|TWO_SIDED|95.0|-3.3|1.5|||Regression, Linear|||||1.5|-3.3|0.440
71037890|NCT02727192|141582789|SUPERIORITY||Mean Difference (Net)|-0.6||||0.41|TWO_SIDED|95.0|-2.1|0.9|||Regression, Linear|||||0.9|-2.1|0.410
71037891|NCT02727192|141582790|SUPERIORITY||Difference in Percentage of Participants|-9.3||||0.33|TWO_SIDED||||||Chi-squared|||||||0.33
71037892|NCT02727192|141582793|SUPERIORITY||Mean Difference (Net)|2.8||||0.058|TWO_SIDED|95.0|-0.1|5.8|||Regression, Linear|||Mental Component Summary score||5.8|-0.1|0.058
70986730|NCT00406315|141483541|SUPERIORITY_OR_OTHER_LEGACY||Mean|-4.21|||||TWO_SIDED|95.0|-5.57|-2.85||||||Total Score, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-2.85|-5.57|
70986731|NCT00406315|141483541|SUPERIORITY_OR_OTHER_LEGACY||Mean|-1.02|||||TWO_SIDED|95.0|-1.31|-0.73||||||Global Rating, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.73|-1.31|
70986732|NCT00406315|141483541|SUPERIORITY_OR_OTHER_LEGACY||Mean|-0.88|||||TWO_SIDED|95.0|-1.13|-0.63||||||Global Rating, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.63|-1.13|
71037893|NCT02727192|141582793|SUPERIORITY||Mean Difference (Net)|-2.1||||0.16|TWO_SIDED|95.0|-5.1|0.8|||Regression, Linear|||Physical Component Summary score||0.8|-5.1|0.160
71037894|NCT02727192|141582794|SUPERIORITY||Mean Difference (Net)|-0.9||||0.11|TWO_SIDED|95.0|-2.0|0.2|||Regression, Linear|||||0.2|-2.0|0.110
71037895|NCT02727192|141582796|SUPERIORITY||Mean Difference (Net)|0.1||||0.85|TWO_SIDED|95.0|-0.5|0.6|||Regression, Linear|||||0.6|-0.5|0.850
71037896|NCT02727192|141582798|SUPERIORITY||Median Difference (Net)|0.3||||0.65|TWO_SIDED|95.0|-1.0|1.6|||Regression, Linear|||||1.6|-1.0|0.650
71037897|NCT02727192|141582799|SUPERIORITY||Mean Difference (Net)|2.6||||0.006|TWO_SIDED|95.0|0.8|4.5|||Regression, Linear|||||4.5|0.8|0.006
71037898|NCT02727192|141582800|SUPERIORITY||Median Difference (Net)|-31.4||||0.389|TWO_SIDED|95.0|-103.4|40.7|||Regression, Linear|||||40.7|-103.4|0.389
71037899|NCT02727192|141582803|SUPERIORITY||Mean Difference (Net)|0.1||||0.697|TWO_SIDED|95.0|-0.3|0.5|||Regression, Logistic|||||0.5|-0.3|0.697
70986733|NCT00406315|141483542|SUPERIORITY_OR_OTHER_LEGACY||Mean|7.88|||||TWO_SIDED|95.0|6.07|9.69||||||Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||9.69|6.07|
70986734|NCT00406315|141483542|SUPERIORITY_OR_OTHER_LEGACY||Mean|5.27|||||TWO_SIDED|95.0|3.89|6.65||||||Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||6.65|3.89|
71037900|NCT00928057|141582805|NON_INFERIORITY_OR_EQUIVALENCE|"To conclude equivalence for glycemic control, the average absolute percent change in fructosamine and 95% confidence interval had to be within 20%.~80 subjects were required to be in each insulin dose group (40 per PN arm) to provide 90% power for an equivalence with alpha=0.05."||||||0.506||||||The threshold for statistical significance, or alpha, is 0.05.|ANOVA|The ANOVA model has effects for subject, insulin dose group, investigator site and order of pen needle use.||"The effects of pen needle type on glycemic control were tested for statistical significance using analysis of variance (ANOVA). The ANOVA model was used to calculate the absolute percent (%)change in fructosamine (% \|∆ Fru\|), with 95 % confidence intervals."||||0.506
71037901|NCT00928057|141582805|NON_INFERIORITY_OR_EQUIVALENCE|"To conclude equivalence for glycemic control, the average absolute percent change in fructosamine and 95% confidence interval had to be within 20%.~80 subjects were required to be in each insulin dose group (40 per PN arm) to provide 90% power for an equivalence with alpha=0.05."||||||0.878||||||The threshold for significance, or alpha, is 0.05.|ANOVA|The ANOVA model has effects for subject, insulin dose group, investigator site and order of pen needle use.||"The effects of pen needle type on glycemic control were tested for statistical significance using ANOVA. The ANOVA model was used to calculate the % \|∆ Fru\|, with 95% confidence intervals."||||0.878
71037902|NCT00928057|141582810|SUPERIORITY_OR_OTHER|||||||0.019||||||The threshold for statistical significance, or alpha, is 0.05.|t-test, 1 sided|||The null hypothesis is that the pain from the 4mm is the same or greater than the pain for the reference. The alternative hypothesis is that the pain from the 4mm is less than the pain for the reference.||||0.019
71037903|NCT00928057|141582810|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||As described for the 4 vs. 5mm statistical analysis.||||<0.001
71037904|NCT05497557|141582814|OTHER|Drug-drug Interaction Assessment|Ratio of geometric least squares mean|0.677|||||TWO_SIDED|90.0|0.547|0.839||||||Ratios of geometric least squares means, and corresponding confidence intervals were obtained by taking the exponential of the least square means (LSMs), differences in LSMs, and corresponding confidence intervals on the natural log (ln) scale.||0.839|0.547|
70986735|NCT00406315|141483543|SUPERIORITY_OR_OTHER_LEGACY||Mean|10.49|||||TWO_SIDED|95.0|5.95|15.02||||||Effectiveness, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||15.02|5.95|
70986736|NCT00406315|141483543|SUPERIORITY_OR_OTHER_LEGACY||Mean|10.49|||||TWO_SIDED|95.0|5.95|15.02||||||Effectiveness, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||15.02|5.95|
70986737|NCT00406315|141483543|SUPERIORITY_OR_OTHER_LEGACY||Mean|18.49|||||TWO_SIDED|95.0|11.94|25.04||||||Side Effect, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||25.04|11.94|
70986738|NCT00406315|141483543|SUPERIORITY_OR_OTHER_LEGACY||Mean|18.49|||||TWO_SIDED|95.0|11.94|25.04||||||Side Effect, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||25.04|11.94|
70986739|NCT00406315|141483543|SUPERIORITY_OR_OTHER_LEGACY||Mean|6.45|||||TWO_SIDED|95.0|2.98|9.93||||||Convenience, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||9.93|2.98|
70986740|NCT00406315|141483543|SUPERIORITY_OR_OTHER_LEGACY||Mean|6.45|||||TWO_SIDED|95.0|2.98|9.93||||||Convenience, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||9.93|2.98|
71037905|NCT05497557|141582815|OTHER|Drug-drug Interaction Assessment|Ratio of geometric least squares mean|0.771|||||TWO_SIDED|90.0|0.628|0.948||||||Ratios of geometric least squares means, and corresponding confidence intervals were obtained by taking the exponential of the least square means (LSMs), differences in LSMs, and corresponding confidence intervals on the natural log (ln) scale.||0.948|0.628|
70986741|NCT00406315|141483543|SUPERIORITY_OR_OTHER_LEGACY||Mean|15.32|||||TWO_SIDED|95.0|9.97|20.68||||||Global Satisfaction, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||20.68|9.97|
70986742|NCT00406315|141483543|SUPERIORITY_OR_OTHER_LEGACY||Mean|15.32|||||TWO_SIDED|95.0|9.97|20.68||||||Global Satisfaction, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||20.68|9.97|
70986743|NCT02142894|141483546|EQUIVALENCE|The results are analyzed in a 2x2 contingency table with 95%CI.|2 x 2 contingency table|87.9|||||TWO_SIDED|95.0|72.7|95.2||||||||95.2|72.7|
71037906|NCT05497557|141582816|OTHER|Drug-drug Interaction Assessment|Ratio of geometric least squares mean|0.766|||||TWO_SIDED|90.0|0.619|0.948||||||Ratios of geometric least squares means, and corresponding confidence intervals were obtained by taking the exponential of the least square means (LSMs), differences in LSMs, and corresponding confidence intervals on the natural log (ln) scale.||0.948|0.619|
70986744|NCT04392011|141483547|OTHER||AUC ratio (geometric mean)|1.39|||||TWO_SIDED|90.0|1.23|1.57||||||||1.57|1.23|
70986745|NCT04392011|141483548|OTHER||AUC ratio (geometric mean)|0.99|||||TWO_SIDED|90.0|0.83|1.19||||||||1.19|0.83|
70986746|NCT04392011|141483550|OTHER||Cmax ratio (midazolam)|1.5|||||TWO_SIDED|90.0|1.32|1.7||||||||1.70|1.32|
70986747|NCT04392011|141483550|OTHER||Cmax ratio (dextromethorphan)|0.96|||||TWO_SIDED|90.0|0.78|1.19||||||||1.19|0.78|
70986748|NCT04392011|141483552|OTHER||half-life ratio (dextromethorphan)|1.0|||||TWO_SIDED|90.0|0.92|1.08||||||||1.08|0.92|
70986749|NCT04392011|141483552|OTHER||half-life ratio (midazolam)|1.07|||||TWO_SIDED|90.0|0.98|1.17||||||||1.17|0.98|
71037907|NCT06078501|141582825|OTHER|||||||0.695||||||The a priori threshold for statistical significance was \<0.05.|Mann-Whitney U test|||||||0.695
71037908|NCT06078501|141582826|OTHER|||||||0.91|||||||Mann-Whitney U test|The a priori threshold for statistical significance was \<0.05.||||||0.91
70986750|NCT01455428|141483563|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.188||0.0002|TWO_SIDED|95.0|-1.08|-0.34||Primary analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||-0.34|-1.08|0.0002
70986751|NCT01455428|141483564|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.149||0.001|TWO_SIDED|95.0|-0.79|-0.2||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 1 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.20|-0.79|0.0010
70986752|NCT01455428|141483564|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.94|-0.35||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 2 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.35|-0.94|<0.0001
70986753|NCT01455428|141483564|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.151||0.0001|TWO_SIDED|95.0|-0.88|-0.29||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 3 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.29|-0.88|0.0001
70986754|NCT01455428|141483564|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.152||0.0009|TWO_SIDED|95.0|-0.81|-0.21||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 4 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.21|-0.81|0.0009
71037909|NCT06078501|141582827|OTHER|||||||1||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||1.0
71037910|NCT06078501|141582828|OTHER|||||||1||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||1.0
71037911|NCT06078501|141582829|OTHER|||||||0.887||||||The a priori threshold for statistical significance was \<0.05.|Mann-Whitney U test|||||||0.887
71037912|NCT06078501|141582830|OTHER|||||||0.887||||||The a priori threshold for statistical significance was \<0.05.|Mann-Whitney U test|||||||0.887
71037913|NCT06078501|141582832|OTHER|||||||1|||||||Fisher Exact|||||||1.0
71037914|NCT06078501|141582833|OTHER|||||||1||||||The a priori threshold for statistical significance was \<0.05.|Mann-Whitney U test|||||||1.0
71037915|NCT06078501|141582834|OTHER|||||||1|||||||Fisher Exact|||||||1.0
71037916|NCT03428750|141582849|SUPERIORITY|||||||0.006|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||0.006
71037917|NCT03428750|141582850|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
71037918|NCT03428750|141582851|SUPERIORITY|||||||0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||0.001
71037919|NCT03428750|141582852|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
71037920|NCT03428750|141582853|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
71037921|NCT03428750|141582854|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
71098233|NCT00286455|141704660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0||||0.152|TWO_SIDED|95.0|-14.3|2.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.2|-14.3|0.152
71037922|NCT03428750|141582855|SUPERIORITY||||||<|0.001|||||||ANCOVA|With factors of treatment group and analysis center adjusted for baseline values in the model||CCH 0.84 mg/Buttock versus Placebo||||<0.001
71037923|NCT03428750|141582856|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
71037924|NCT03428750|141582857|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
71037925|NCT01919112|141582873|OTHER|Regression models using interaction terms will used to assess for heterogeneity of intervention effects across the novel radiological variable corticobulbar tract (CBT)-lesion load, a combined measure of lesion size and location. For purposes of the analysis, the CBT-lesion load was dichotomized into 2 groups based on the median CBT-lesion load volume.||||||0.116||||||Interaction p-values will be considered statistically significant at the 0.15 level of significance given the relatively low power for tests of interaction to detect a true interaction.|2-way analysis of variance with interact|The tDCS intervention was the main variable of interest, PAS score the main outcome and CBT-lesion load was the interaction term used.||The aim for this analysis was to assess for effect modification of the trial intervention across the novel radiological variable corticobulbar tract-lesion load.||||0.116
71037926|NCT01339247|141582958|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency - ANVISA - upon a manufacturing site change.|Ratio T formulation/R formulation|1.0886|||||TWO_SIDED|90.0|1.0011|1.177|||||The ratio between the geometric means of the test (T) and reference (R) formulations was calculated.|||1.1770|1.0011|
71037927|NCT01339247|141582959|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency - ANVISA - upon a manufacturing site change.|Ratio T formulation/R formulation|1.0246|||||TWO_SIDED|90.0|0.9676|1.0849|||||The ratio between the geometric means of the test (T) and reference (R) formulations was calculated.|||1.0849|0.9676|
71037928|NCT01339247|141582960|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency - ANVISA - upon a manufacturing site change.|Ratio T formulation/R formulation|1.0317|||||TWO_SIDED|90.0|0.9716|1.0956|||||The ratio between the geometric means of the test (T) and reference (R) formulations was calculated.|||1.0956|0.9716|
71037929|NCT00985439|141582961|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.407|STANDARD_ERROR_OF_MEAN|2.643|<|0.001|TWO_SIDED|95.0|6.195|16.619|||ANCOVA|||||16.619|6.195|<0.001
71037930|NCT02960295|141582970|OTHER|There was no comparison group and no test of statistical significance.||||||||||||||||In this interventional study the number of glucose checks per patient per day was calculated as stated above. There was no comparison group and no test of statistical significance.|This is a simple calculation of the mean (sd) of the number of glucose checks per pt per day|||
71037931|NCT02960295|141582971|OTHER|This is an observational study|||||<|0.05|||||||Pearson correlation (r)|||||||<0.05
71037932|NCT02960295|141582971|OTHER|This is an observational study|||||<|0.05|||||||Pearson correlation coefficient (r)|||||||<0.05
71037933|NCT02960295|141582971|OTHER||||||<|0.05|||||||Pearson correlation coefficient (r)|||||||<0.05
71037934|NCT01906372|141582995|SUPERIORITY_OR_OTHER||Frequency of achieving primary endpoint|0.7|||||TWO_SIDED|||||Open label single arm pilot trial without control group.||||||||
71037935|NCT01906372|141582996|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71037936|NCT04428307|141582997|SUPERIORITY||Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.61|2.02||||||||2.02|0.61|
71037937|NCT04428307|141582997|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.49|1.71||||||||1.71|0.49|
71037938|NCT04428307|141582998|SUPERIORITY||Risk Ratio (RR)|1.22|||||TWO_SIDED|95.0|0.83|1.8||||||||1.80|0.83|
71037939|NCT04428307|141582998|SUPERIORITY||Risk Ratio (RR)|1.15|||||TWO_SIDED|95.0|0.81|1.62||||||||1.62|0.81|
71037940|NCT04428307|141582999|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.8|1.09||||||||1.09|0.80|
71037941|NCT04428307|141582999|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.85|1.16||||||||1.16|0.85|
71037942|NCT04428307|141583000|SUPERIORITY||Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.75|1.73||||||||1.73|0.75|
71037943|NCT04428307|141583000|SUPERIORITY||Risk Ratio (RR)|1.15|||||TWO_SIDED|95.0|0.77|1.74||||||||1.74|0.77|
71037944|NCT04428307|141583001|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.95|1.11||||||||1.11|0.95|
71037945|NCT04428307|141583001|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.89|1.04||||||||1.04|0.89|
70986755|NCT01455428|141483564|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.153||0.0009|TWO_SIDED|95.0|-0.81|-0.21||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 5 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.21|-0.81|0.0009
70986756|NCT01455428|141483564|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.153||0.0001|TWO_SIDED|95.0|-0.89|-0.29||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 6 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.29|-0.89|0.0001
70986757|NCT01455428|141483564|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.154|<|0.0001|TWO_SIDED|95.0|-1.01|-0.41||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 7 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.41|-1.01|<0.0001
70986758|NCT01455428|141483564|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.154|<|0.0001|TWO_SIDED|95.0|-1.0|-0.4||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 8 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.40|-1.00|<0.0001
70986759|NCT01455428|141483566|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.2||0.0079|TWO_SIDED|95.0|-0.93|-0.14||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||-0.14|-0.93|0.0079
70986760|NCT01455428|141483567|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.172||0.0024|TWO_SIDED|95.0|-0.86|-0.19||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 1 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.19|-0.86|0.0024
71037946|NCT05604014|141583007|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.49|TWO_SIDED||||||t-test, 2 sided|||||||0.49
71037947|NCT05604014|141583008|SUPERIORITY||Mean Difference (Final Values)|-0.69||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.5
71037948|NCT05604014|141583009|SUPERIORITY||Mean Difference (Final Values)|-1.44||||0.16|TWO_SIDED||||||t-test, 2 sided|||||||0.16
71037949|NCT05604014|141583010|SUPERIORITY||Mean Difference (Final Values)|-0.78||||0.44|TWO_SIDED||||||t-test, 2 sided|||||||0.44
70986761|NCT01455428|141483567|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.173||0.0002|TWO_SIDED|95.0|-0.99|-0.31||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 2 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.31|-0.99|0.0002
71037950|NCT02054715|141583030|OTHER||Mean Difference (MP - PE)|-0.1|STANDARD_ERROR_OF_MEAN|2.0||0.9621|TWO_SIDED|95.0|-4.1|3.9|||F-Test|||Two-sided F-Test as a statistical comparing MP and PE means.||3.9|-4.1|0.9621
71037951|NCT02054715|141583031|OTHER||Mean Difference (MP - PE)|0.18|STANDARD_ERROR_OF_MEAN|1.57||0.9065|TWO_SIDED|95.0|-2.89|3.26|||F-test|||Two-sided F-Test comparing the MP and PE means.||3.26|-2.89|0.9065
71037952|NCT02054715|141583032|OTHER||Mean Difference (MP - PE)|-0.05|STANDARD_ERROR_OF_MEAN|1.4||0.9709|TWO_SIDED|95.0|-2.79|2.69|||F-Test|||Two-sided F-Test comparing the MP and PE means.||2.69|-2.79|0.9709
71037953|NCT02054715|141583033|OTHER|||||||0.014|||||||Chi-squared|||Chi-square test between MP and PE. 69% of subjects that got the Multimedia Psychoeducation intervention chose to participate in a clinical trial, compared with 62% in the Print Education group||||0.014
71037954|NCT01442376|141583040|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 15% at an alpha level of 2.5% in a 1-sided test (equivalent to 5.0% 2-sided test) to reject the null hypothesis that the study drug was inferior to the active control drug by more than the non-inferiority margin.|Risk Difference (RD)|0.36|||||TWO_SIDED|97.5|-11.7|12.4||||||The stratum adjusted Mantel-Haenszel method was used to compute the confidence interval (CI) of the difference in proportion. If the lower bound of the 97.5% CI of either the difference (CR0-24h palonosetron 20 mcg/kg - CR0-24h ondansetron) or the difference (CR0-24h palonosetron 10 mcg/kg - CR0-24h ondansetron) was strictly superior to the non-inferiority margin (δ=-0.15) then the null hypothesis (H0) was rejected. A power of 80% was used for sample size computation.||12.4|-11.7|
71037955|NCT01442376|141583040|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 15% at an alpha level of 2.5% in a 1-sided test (equivalent to 5.0% 2-sided test) to reject the null hypothesis that the study drug was inferior to the active control drug by more than the non-inferiority margin.|Risk Difference (RD)|-4.4|||||TWO_SIDED|97.5|-16.4|7.6||||||The stratum adjusted Mantel-Haenszel method was used to compute the confidence interval (CI) of the difference in proportion. If the lower bound of the 97.5% CI of either the difference (CR0-24h palonosetron 20 mcg/kg - CR0-24h ondansetron) or the difference (CR0-24h palonosetron 10 mcg/kg - CR0-24h ondansetron) was strictly superior to the non-inferiority margin (δ=-0.15) then the null hypothesis (H0) was rejected. A power of 80% was used for sample size computation.||7.6|-16.4|
71037956|NCT03499873|141583048|EQUIVALENCE|90% CI on the Test-to-Reference difference for the proportion of subjects with cure should be contained within the interval \[-0.20, +0.20\]|Mean Difference (Net)|-0.026|||||TWO_SIDED|90.0|-0.124|0.073||||||||0.073|-0.124|
71037957|NCT03499873|141583048|SUPERIORITY|||||||0.0005|||||||ANOVA|||||||0.0005
71037958|NCT03499873|141583048|SUPERIORITY|||||||0.0003|||||||ANOVA|||||||0.0003
70986762|NCT01455428|141483567|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.173||0.0012|TWO_SIDED|95.0|-0.91|-0.22||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 3 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.22|-0.91|0.0012
70986763|NCT01455428|141483567|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.174||0.0101|TWO_SIDED|95.0|-0.79|-0.11||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 4 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.11|-0.79|0.0101
70986764|NCT01455428|141483567|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.175||0.0258|TWO_SIDED|95.0|-0.73|-0.05||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 5 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.05|-0.73|0.0258
70986765|NCT01455428|141483567|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.175||0.026|TWO_SIDED|95.0|-0.74|-0.05||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 6 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.05|-0.74|0.0260
70986766|NCT01455428|141483567|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.175||0.0062|TWO_SIDED|95.0|-0.83|-0.14||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 7 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.14|-0.83|0.0062
70986767|NCT01455428|141483567|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.176||0.0081|TWO_SIDED|95.0|-0.81|-0.12||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 8 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.12|-0.81|0.0081
70986768|NCT01455428|141483568|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007||||||Analysis was two-sided and performed at the 0.05 significance level|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel test comparing pregabalin to placebo adjusted for center.||||0.0007
71037959|NCT01075516|141583049|OTHER|Continuous data summarized as mean ± Standard Deviation (SD). For cost data Wilcoxon rank-sum test was used to compare costs across groups. The analysis evaluated HCS perspective of group membership impact (SC vs RM) on total health care cost, adjusting for covariates that were significantly different between the groups at the .2 significance level. Differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals)|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
70986769|NCT01455428|141483571|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-8.18|STANDARD_ERROR_OF_MEAN|1.932|<|0.0001|TWO_SIDED|95.0|-11.99|-4.37||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||-4.37|-11.99|<0.0001
71098234|NCT00286455|141704661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.2||||0.12|TWO_SIDED|95.0|-11.7|1.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.4|-11.7|0.120
71098235|NCT00286455|141704661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.5||||0.104|TWO_SIDED|95.0|-12.1|1.1||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.1|-12.1|0.104
71098236|NCT00286455|141704662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.247|TWO_SIDED|95.0|-10.9|2.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.8|-10.9|0.247
71098237|NCT00286455|141704662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.4||||0.129|TWO_SIDED|95.0|-12.3|1.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.6|-12.3|0.129
71098238|NCT00286455|141704663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73||||0.671|TWO_SIDED|95.0|-4.14|2.67||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.67|-4.14|0.671
71098239|NCT00286455|141704663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15||||0.218|TWO_SIDED|95.0|-5.57|1.27||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.27|-5.57|0.218
70986770|NCT01455428|141483572|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.107||0.0007|TWO_SIDED|95.0|-0.58|-0.16||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||-0.16|-0.58|0.0007
70986771|NCT01455428|141483574|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-7.21|STANDARD_ERROR_OF_MEAN|2.464||0.0039|TWO_SIDED|95.0|-12.08|-2.35||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||-2.35|-12.08|0.0039
70986772|NCT01455428|141483575|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.73|STANDARD_ERROR_OF_MEAN|2.783||0.5351|TWO_SIDED|95.0|-3.76|7.22||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||7.22|-3.76|0.5351
70986773|NCT01455428|141483576|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|2.579||0.8892|TWO_SIDED|95.0|-5.45|4.73||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||4.73|-5.45|0.8892
70986774|NCT01455428|141483577|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.147||0.0035|TWO_SIDED|95.0|0.14|0.72||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||0.72|0.14|0.0035
70986775|NCT01455428|141483578|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.8||||0.0972|TWO_SIDED|95.0|0.9|3.6||Analysis was two-sided and performed at the 0.05 significance level.|Regression, Logistic|||Analysis performed using a logistic regression model with treatment and center as factors, and baseline value as a covariate.||3.60|0.90|0.0972
71037960|NCT01075516|141583050|OTHER|Continuous data are summarized as mean ± SD. For cost data the Wilcoxon rank-sum test was used to compare costs across groups. This analysis evaluated the impact of group membership (SC vs RM) on cardiovascular hospitalization timeframe (outcome), adjusting for covariates that were significantly different between the groups at the .2 significance level. Differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals).||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
70986776|NCT01455428|141483579|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|3.161||0.5702|TWO_SIDED|95.0|-4.44|8.03||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||8.03|-4.44|0.5702
70986777|NCT01455428|141483580|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.87|STANDARD_ERROR_OF_MEAN|2.194||0.6929|TWO_SIDED|95.0|-3.46|5.2||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||5.20|-3.46|0.6929
70986778|NCT01455428|141483581|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.84|STANDARD_ERROR_OF_MEAN|1.92||0.1403|TWO_SIDED|95.0|-6.63|0.94||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||0.94|-6.63|0.1403
70986779|NCT01455428|141483582|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.118|<|0.0001|TWO_SIDED|95.0|-0.86|-0.39||Analysis was two-sided and performed at the 0.05 significance level.|ANOVA|||Analysis was performed using a general linear model with treatment and center as factors.||-0.39|-0.86|<0.0001
71098240|NCT00286455|141704664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.54||||0.403|TWO_SIDED|95.0|-2.07|5.14||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.14|-2.07|0.403
71098241|NCT00286455|141704664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29||||0.487|TWO_SIDED|95.0|-2.35|4.93||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.93|-2.35|0.487
71098242|NCT00286455|141704665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.143|TWO_SIDED|95.0|-0.88|6.08||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.08|-0.88|0.143
71098243|NCT00286455|141704665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.974|TWO_SIDED|95.0|-3.46|3.57||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.57|-3.46|0.974
71098244|NCT00286455|141704666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.97||||0.612|TWO_SIDED|95.0|-2.78|4.71||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.71|-2.78|0.612
70986780|NCT01455428|141483583|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.113|<|0.0001|TWO_SIDED|95.0|-0.72|-0.27||Analysis was two-sided and performed at the 0.05 significance level.|ANOVA|||Analysis was performed using a general linear model with treatment and center as factors.||-0.27|-0.72|<0.0001
71098245|NCT00286455|141704666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04||||0.587|TWO_SIDED|95.0|-4.82|2.74||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.74|-4.82|0.587
71037961|NCT01075516|141583051|OTHER|Continuous data are summarized as mean ± SD. This analysis evaluated the impact of group membership (SC vs RM) on total health care cost (outcome), adjusting for covariates that were significantly different between the groups at the .2 significance level. However, as the arithmetic mean is the most informative measurement for policy decisions, differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals).||||||0.8||||||Comparison of utility at baseline from the EQ-5D-3L questionnaire.|t-test, 2 sided|||For the patient perspective, the quality of life associated with the 2 strategies was assessed. Quality of life is reported as utility values from the EuroQoL Group 5-Dimension 3-Level Self-Report (EQ-5D-3L) questionnaire and quality adjusted life years (QALYs) were based on utility (patients' preferences). The EQ-5D-3L questionnaire was administered to each patient at baseline and at 12 months in order to calculate utility values (from 0 to 1).||||0.80
71037962|NCT01075516|141583051|OTHER|Continuous data are summarized as mean ± SD. This analysis evaluated the impact of group membership (SC vs RM) on total health care cost (outcome), adjusting for covariates that were significantly different between the groups at the .2 significance level. However, as the arithmetic mean is the most informative measurement for policy decisions, differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals).||||||0.38||||||Comparison of utility at 12 months from the EQ-5D-3L questionnaire.|t-test, 2 sided|||For the patient perspective, the quality of life associated with the 2 strategies was assessed. Quality of life is reported as utility values from the EQ-5D-3L questionnaire and quality adjusted life years (QALYs) were based on utility (patients' preferences). The EQ-5D-3L questionnaire was administered to each patient at baseline and at 12 months in order to calculate utility values (from 0 to 1).||||0.38
71037963|NCT01075516|141583051|OTHER|Continuous data are summarized as mean ± SD. This analysis evaluated the impact of group membership (SC vs RM) on total health care cost (outcome), adjusting for covariates that were significantly different between the groups at the .2 significance level. However, as the arithmetic mean is the most informative measurement for policy decisions, differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals).||||||0.53|||||||t-test, 2 sided|||For the patient perspective, the quality of life associated with the 2 strategies was assessed. Quality of life is reported as utility values from the EQ-5D-3L questionnaire and quality adjusted life years (QALYs) were based on utility (patients' preferences). The EQ-5D-3L questionnaire was administered to each patient at baseline and at 12 months in order to calculate utility values (from 0 to 1).||||0.53
71037964|NCT02252016|141583053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.5|||||TWO_SIDED|95.0|-7.3|23.3||||||The estimated difference (± 95% confidence interval \[CI\]) in percentage of participants experiencing an AE in the Immediate versus Deferred arms was determined.||23.3|-7.3|
71037965|NCT02252016|141583054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.155|TWO_SIDED|95.0|-10.2|1.6|||Miettinen & Nurminen method|||The estimated difference (± 95% CI) in percentage of participants withdrawing from study treatment due to an AE(s) in the Immediate versus Deferred arms was determined.||1.6|-10.2|0.155
71037966|NCT00840281|141583056|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.0||||||90.0|94.9|105.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||105|94.9|
71037967|NCT00840281|141583057|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|98.6|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||103|98.6|
71037968|NCT00840281|141583058|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|98.7|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103|98.7|
71037969|NCT03031795|141583110|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance was set at \< 0.05 for each row comparison with no adjustment for multiple comparisons.|Wilcoxon rank sum test|||"A 2 point difference was used to power the study. This is consistent with previous definitions of a clinically meaningful reductions in pain and provides a visually meaningful change on the 0-10 numerical rating scale with anchors at every other point, for example moving from very severe (8) to severe pain (6) or from moderate pain (4) to mild pain (2)."||||< 0.05
71098246|NCT00286455|141704667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.514|TWO_SIDED|95.0|-2.0|3.99||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.99|-2.00|0.514
71037970|NCT02227238|141583115|SUPERIORITY|Non-inferiority of DTG plus 2 NRTI's was to be declared if the lower bound of 95% confidence interval (CI) for the difference in snapshot response rates (DTG - LPV/RTV) is greater than - 12%. This was also performed using the Per-Protocol (PP) Population. If both analyses show non-inferiority, the hypothesis of antiviral effect of DTG + 2 NRTI's was superior to LPV/RTV + 2 NRTIs was to be tested.|Proportion difference|13.8|||<|0.001|TWO_SIDED|95.0|7.3|20.3|||Cochran-Mantel-Haenszel||Adjusted proportion difference, calculated as proportion on DTG minus that on LPV/RTV and based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline plasma HIV-1 RNA and number of fully active background NRTIs, has been presented.||Superiority would be declared if the lower end of the confidence interval was above 0%|20.3|7.3|<.001
70986781|NCT01455428|141483585|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.315||0.506|TWO_SIDED|95.0|-0.83|0.41||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis was performed using a general linear model with treatment and center as factors, and the baseline value as a covariate.||0.41|-0.83|0.5060
70986782|NCT01455428|141483586|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.285||0.7247|TWO_SIDED|95.0|-0.66|0.46||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis was performed using a general linear model with treatment and center as factors, and the baseline value as a covariate.||0.46|-0.66|0.7247
70986783|NCT03303339|141483587|OTHER||Maximum Tolerated Dose|60.0|||||TWO_SIDED|||||||||||||
70986784|NCT00257192|141483611|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-1.8|STANDARD_ERROR_OF_MEAN|1.26||0.153|TWO_SIDED|95.0|-4.28|0.67||Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|ANCOVA|P-value for final analysis is to be adjusted due to planned interim analysis (0.0462).||Sample size for 85% power 2-tailed 0.05 significance level based on expected difference of -5 with average within-group standard deviation=13 was 276 subjects (2 to 1 ratio of enrollment: 184 ziprasidone, 92 placebo). Interim analysis at 60 percent (%) enrollment (ITT population): may stop trial early for efficacy (2-sided p-value less than (\<) 0.0124) or for futility (2-sided p-value greater than (\>) 0.4772; The final analysis is to employ a 2-sided p-value \<0.0462.||0.67|-4.28|0.1530
70986785|NCT00257192|141483612|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.21|STANDARD_ERROR_OF_MEAN|0.14||0.1289|TWO_SIDED|95.0|-0.48|0.06||Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|ANCOVA|Hochberg procedure was applied to p-value to preserve type I error in the analysis of key secondary endpoints (PANSS total score and CGI-S).||Difference from placebo||0.06|-0.48|0.1289
70986786|NCT00257192|141483613|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-2.57|STANDARD_ERROR_OF_MEAN|2.0||0.1987||95.0|-6.5|1.36||Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|ANCOVA|Hochberg procedure was applied to p-value to preserve type I error in the analysis of key secondary endpoints (PANSS total score and CGI-S).||Total score: difference from placebo||1.36|-6.50|0.1987
70986787|NCT00257192|141483614|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-1.33|STANDARD_ERROR_OF_MEAN|0.65||0.0412|TWO_SIDED|95.0|-2.61|-0.05||Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|ANCOVA|||Positive score: difference from placebo||-0.05|-2.61|0.0412
71037971|NCT02227238|141583118|OTHER||Proportion difference|5.7|||||TWO_SIDED|95.0|2.2|9.3|||||Proportion difference, calculated as proportion on DTG minus proportion on LPV/RTV, at Week 24 has been presented.|||9.3|2.2|
71037972|NCT02227238|141583118|OTHER||Proportion difference|9.8|||||TWO_SIDED|95.0|5.3|14.4|||||Proportion difference, calculated as proportion on DTG minus proportion on LPV/RTV, at Week 48 has been presented.|||14.4|5.3|
70986788|NCT00257192|141483614|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.43|STANDARD_ERROR_OF_MEAN|0.58||0.4661|TWO_SIDED|95.0|-1.57|0.72||Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|ANCOVA|||Negative score: difference from placebo||0.72|-1.57|0.4661
70986789|NCT00257192|141483615|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.19|STANDARD_ERROR_OF_MEAN|0.14||0.182|TWO_SIDED|95.0|-0.47|0.09||Mixed effects MMRM with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects.|ANOVA|||Difference from placebo||0.09|-0.47|0.1820
71037973|NCT02227238|141583145|OTHER||Mean Difference (Net)|-0.171||||0.001|TWO_SIDED|95.0|-0.272|-0.069|||Multiple imputation||Mean difference at Week 24 was calculated using multiple imputation using missing at random, adjusting for Baseline LDL cholesterol, Baseline plasma HIV-1 RNA, Baseline number of Fully Active NRTIs in the background regimen and Age|||-0.069|-0.272|0.0010
70986790|NCT00257192|141483623|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|1.34|STANDARD_ERROR_OF_MEAN|1.19||0.2613|TWO_SIDED|95.0|-1.01|3.69||SAS PROC MIXED to fit a mixed model analysis of covariance with treatment and region as fixed effects and baseline score as covariate.|ANCOVA|Observed cases at Week 6.||Neurocognitive Index score at Week 6: difference from placebo||3.69|-1.01|0.2613
70986791|NCT00570739|141483630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.0123|TWO_SIDED|95.0|-0.27|-0.03||P-Value is for the LS mean difference between treatment groups|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 4 weeks||-0.03|-0.27|0.0123
70986792|NCT00570739|141483630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.0201|TWO_SIDED|95.0|-0.33|-0.03||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||-0.03|-0.33|0.0201
70986793|NCT00570739|141483630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.0239|TWO_SIDED|95.0|-0.36|-0.03||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 12 weeks||-0.03|-0.36|0.0239
70986794|NCT00570739|141483630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0046|TWO_SIDED|95.0|-0.42|-0.08||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks||-0.08|-0.42|0.0046
70986795|NCT00570739|141483631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1||||0.1112|TWO_SIDED|95.0|-11.3|1.2|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 4 Weeks||1.2|-11.3|0.1112
70986796|NCT00570739|141483631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3||||0.2167|TWO_SIDED|95.0|-8.6|2.0|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||2.0|-8.6|0.2167
70986797|NCT00570739|141483631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.7269|TWO_SIDED|95.0|-7.0|4.9|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 12 weeks||4.9|-7.0|0.7269
71037974|NCT02227238|141583145|OTHER||Mean Difference (Net)|-0.147||||0.01|TWO_SIDED|95.0|-0.259|-0.035|||'Multiple imputation||Mean difference at Week 48 was calculated using multiple imputation using missing at random, adjusting for Baseline LDL cholesterol, Baseline plasma HIV-1 RNA, Baseline number of Fully Active NRTIs in the background regimen and Age|||-0.035|-0.259|0.0100
71037975|NCT02227238|141583146|OTHER||Mean Difference (Net)|-0.542|||<|0.0001|TWO_SIDED|95.0|-0.729|-0.356|||Multiple imputation||Estimates at Week 24 are calculated using multiple imputation using missing at random, adjusting for Baseline total cholesterol/HDL ratio, Baseline plasma HIV-1 RNA, Baseline number of Fully Active NRTIs in the background regimen and Age.|||-0.356|-0.729|<0.0001
71037976|NCT02227238|141583146|OTHER||Mean Difference (Net)|-0.358||||0.0004|TWO_SIDED|95.0|-0.555|-0.161|||Multiple imputation||Estimates at Week 48 are calculated using multiple imputation using missing at random, adjusting for Baseline total cholesterol/HDL ratio, Baseline plasma HIV-1 RNA, Baseline number of Fully Active NRTIs in the background regimen and Age.|||-0.161|-0.555|0.0004
71037977|NCT03966911|141583158|SUPERIORITY||Intercept from ANCOVA as agreement rate|88.0|||<|0.041|TWO_SIDED|91.8|86.05|89.95|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).|A group sequential study design was utilized to perform interim analysis. For the final stage, the p-value is 0.041.|||89.95|86.05|<0.041
71037978|NCT03966911|141583158|SUPERIORITY||Intercept from ANCOVA as agreement rate|87.96|||<|0.041|TWO_SIDED|91.8|86.13|89.8|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).|A group sequential study design was utilized to perform interim analysis. For the final stage, the p-value is 0.041.|||89.80|86.13|<0.041
71037979|NCT03966911|141583158|SUPERIORITY||Intercept from ANCOVA as agreement rate|84.59||||0.041|TWO_SIDED|91.8|82.02|87.17|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).|A group sequential study design was utilized to perform interim analysis. For the final stage, the p-value is 0.041.|||87.17|82.02|0.041
71037980|NCT03966911|141583158|SUPERIORITY||Intercept from ANCOVA as agreement rate|81.05|||<|0.041|TWO_SIDED|91.8|77.58|84.53|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).|A group sequential study design was utilized to perform interim analysis. For the final stage, the p-value is 0.041.|||84.53|77.58|<0.041
70986798|NCT00570739|141483631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.4063|TWO_SIDED|95.0|-8.4|3.4|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks||3.4|-8.4|0.4063
70986799|NCT00570739|141483631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.4909|TWO_SIDED|95.0|-8.0|3.9|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks (LOCF)||3.9|-8.0|0.4909
70986800|NCT00570739|141483632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.303||||0.7606|TWO_SIDED|95.0|-2.259|1.653||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 4 weeks||1.653|-2.259|0.7606
70986801|NCT00570739|141483632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.015||||0.1782|TWO_SIDED|95.0|-2.477|0.447||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 weeks||0.447|-2.477|0.1782
70986802|NCT00570739|141483632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.504||||0.0332|TWO_SIDED|95.0|-2.887|-0.121||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 12 weeks||-0.121|-2.887|0.0332
70986803|NCT00570739|141483632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176||||0.861|TWO_SIDED|95.0|-1.805|2.158||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks||2.158|-1.805|0.8610
70986804|NCT00570739|141483632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.8196|TWO_SIDED|95.0|-1.599|2.019||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks (LOCF)||2.019|-1.599|0.8196
70986805|NCT00570739|141483633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.153||||0.1078|TWO_SIDED|95.0|-0.34|0.034||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 weeks||0.034|-0.340|0.1078
71037981|NCT01986647|141583159|SUPERIORITY_OR_OTHER|||||||0.2691|||||||Mixed Models Analysis|linear mixed model due to clustering by facility and multiple imputation for missing data||||||0.2691
71037982|NCT01986647|141583160|SUPERIORITY_OR_OTHER|||||||0.6087|||||||Mixed Models Analysis|linear mixed model due to clustering by facility and multiple imputation for missing data||||||0.6087
71037983|NCT01986647|141583161|SUPERIORITY_OR_OTHER|||||||0.0022|||||||Mixed Models Analysis|linear mixed model due to clustering by facility and multiple imputation for missing data||||||0.0022
71037984|NCT01986647|141583162|SUPERIORITY_OR_OTHER|||||||0.0344|||||||Mixed Models Analysis|linear mixed model due to clustering by facility and multiple imputation for missing data||||||0.0344
71037985|NCT01986647|141583163|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.6879|TWO_SIDED|95.0|0.49|1.6|||Regression, Logistic|||||1.60|0.49|0.6879
71037986|NCT01986647|141583164|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.88||||0.5719|TWO_SIDED|95.0|0.56|1.37|||Regression, Logistic|||||1.37|0.56|0.5719
71037987|NCT01986647|141583165|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.489|TWO_SIDED|95.0|0.44|5.53|||Regression, Logistic|||||5.53|0.44|0.489
71037988|NCT01986647|141583166|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.12||||0.2981|TWO_SIDED|95.0|0.37|26.6|||Regression, Logistic|||||26.6|0.37|0.2981
71098247|NCT00286455|141704667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.899|TWO_SIDED|95.0|-2.83|3.22||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.22|-2.83|0.899
71098248|NCT00286455|141704668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.885|TWO_SIDED|95.0|-3.09|3.58||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.58|-3.09|0.885
71037989|NCT01986647|141583167|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.9279|TWO_SIDED|95.0|0.3|3.74|||Regression, Logistic|||||3.74|0.30|0.9279
71037990|NCT01986647|141583168|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.5835|TWO_SIDED|95.0|0.67|2.06|||Regression, Logistic|||||2.06|0.67|0.5835
71037991|NCT01986647|141583169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.46||0.18|TWO_SIDED||||||Mixed Models Analysis|||||||0.18
71037992|NCT01986647|141583170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|1.42||0.73|TWO_SIDED||||||Mixed Models Analysis|||||||0.73
71037993|NCT01986647|141583171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.28||0.71|TWO_SIDED||||||Mixed Models Analysis|||||||0.71
71037994|NCT01986647|141583172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.004||0.77|TWO_SIDED||||||Mixed Models Analysis|||||||0.77
71037995|NCT01986647|141583173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.44||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||0.80
71037996|NCT01986647|141583174|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52||||0.0324|TWO_SIDED|95.0|0.29|0.95|||Regression, Logistic|||||0.95|0.29|0.0324
71037997|NCT00199901|141583207|SUPERIORITY||Hazard Ratio (HR)|0.913|||||TWO_SIDED|95.0|0.532|1.568||||||||1.568|0.532|
71037998|NCT00199901|141583209|SUPERIORITY||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.532|1.455||||||||1.455|0.532|
71037999|NCT00199901|141583210|SUPERIORITY||Hazard Ratio (HR)|0.911|||||TWO_SIDED|95.0|0.514|1.614||||||||1.614|0.514|
71038000|NCT05776901|141583218|OTHER|Descriptive statistics and measures of central tendency, including mean, median, and standard deviation of the System Usability Scores collected from the baseline and week 3 were computed. Then, a two-sided, paired sample t-test was conducted to evaluate the change in mean System Usability Scores from baseline at week 3.|Mean diff in SUS from baseline at week 3|34.17|STANDARD_ERROR_OF_MEAN|14.49|<|0.05|TWO_SIDED|95.0|-28.04|96.37|||t-test, 2 sided|||||96.37|-28.04|<0.05
71038001|NCT02302716|141583222|NON_INFERIORITY_OR_EQUIVALENCE|The primary treatment comparison was to compare LY2963016 versus Lantus at the non-inferiority margin of +0.4%. If the upper limit of the 95% confidence interval on the change from baseline to 24-week HbA1c level for LY2963016 versus Lantus was below +0.4%, then LY2963016 would be declared non-inferior to Lantus.|Mean Difference (Final Values)|-0.04||||0.693|TWO_SIDED|95.0|-0.22|0.15|||Mixed Models Analysis|||||0.15|-0.22|0.693
71038002|NCT01911429|141583247|SUPERIORITY_OR_OTHER||LS mean difference (SE)|-8.0||||0.0003|TWO_SIDED|95.0|-12.4|-3.7|||LS mean difference (SE)|||"The sample size was estimated to provide at least 85% power to reject at least one of the null hypotheses of no difference between placebo and lurasidone doses.~LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM)."||-3.7|-12.4|0.0003
71038003|NCT01911429|141583247|SUPERIORITY_OR_OTHER||LS mean difference (SE)|-7.7||||0.0006|TWO_SIDED|95.0|-12.1|-3.4|||LS mean difference (SE)|||"The sample size was estimated to provide at least 85% power to reject at least one of the null hypotheses of no difference between placebo and lurasidone doses.~LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM)."||-3.4|-12.1|0.0006
71038004|NCT01911429|141583248|SUPERIORITY_OR_OTHER||LS mean difference (SE)|-0.47||||0.0003|TWO_SIDED|95.0|-0.73|-0.22|||LS mean difference (SE)|||LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||-0.22|-0.73|0.0003
71098249|NCT00286455|141704668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.958|TWO_SIDED|95.0|-3.28|3.46||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.46|-3.28|0.958
71098250|NCT00286455|141704669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.051||||0.003|TWO_SIDED|95.0|-0.084|-0.018||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.018|-0.084|0.003
70986806|NCT00570739|141483633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.141||||0.1146|TWO_SIDED|95.0|-0.317|0.035||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks (LOCF)||0.035|-0.317|0.1146
70986807|NCT00570739|141483634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9933|TWO_SIDED|95.0|-9.3|9.4||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 weeks||9.4|-9.3|0.9933
70986808|NCT00570739|141483634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.8203|TWO_SIDED|95.0|-10.5|8.3||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 weeks LOCF||8.3|-10.5|0.8203
70986809|NCT00570739|141483635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.0||||0.195|TWO_SIDED|95.0|-17.5|3.6||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks||3.6|-17.5|0.1950
70986810|NCT00570739|141483635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.7||||0.1583|TWO_SIDED|95.0|-18.3|3.0||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||3.0|-18.3|0.1583
70986811|NCT00570739|141483636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1||||0.3663|TWO_SIDED|95.0|-16.1|6.0||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||6.0|-16.1|0.3663
70986812|NCT00570739|141483636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6||||0.2524|TWO_SIDED|95.0|-17.9|4.7||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||4.7|-17.9|0.2524
70986813|NCT00570739|141483637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.051||||0.8158|TWO_SIDED|95.0|-7.828|9.929||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||9.929|-7.828|0.8158
70986814|NCT00570739|141483637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.565||||0.7433|TWO_SIDED|95.0|-10.966|7.836||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||7.836|-10.966|0.7433
70986815|NCT00570739|141483638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215||||0.5161|TWO_SIDED|95.0|-0.437|0.867||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||0.867|-0.437|0.5161
70986816|NCT00570739|141483638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.8319|TWO_SIDED|95.0|-0.581|0.722||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||0.722|-0.581|0.8319
70986817|NCT00570739|141483639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.19|||<|0.0001|TWO_SIDED|95.0|-22.61|-13.76|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||-13.76|-22.61|<0.0001
70986818|NCT00570739|141483639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.08|||<|0.0001|TWO_SIDED|95.0|-22.09|-12.08|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||-12.08|-22.09|<0.0001
71098251|NCT00286455|141704669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.072|||<|0.001|TWO_SIDED|95.0|-0.105|-0.038||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.038|-0.105|<0.001
71098252|NCT00286455|141704670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.069|||<|0.001|TWO_SIDED|95.0|-0.099|-0.038||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.038|-0.099|<0.001
71098253|NCT00286455|141704670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.052||||0.001|TWO_SIDED|95.0|-0.083|-0.021||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.021|-0.083|0.001
71098254|NCT00286455|141704671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.068|||<|0.001|TWO_SIDED|95.0|-0.103|-0.032||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.032|-0.103|<0.001
70986819|NCT00570739|141483639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.33|||<|0.0001|TWO_SIDED|95.0|-20.96|-11.69|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||-11.69|-20.96|<0.0001
70986820|NCT00570739|141483640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4|||<|0.0001|TWO_SIDED|95.0|-15.99|-8.81|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||-8.81|-15.99|<0.0001
70986821|NCT00570739|141483640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.28|||<|0.0001|TWO_SIDED|95.0|-13.23|-5.34|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||-5.34|-13.23|<0.0001
70986822|NCT00570739|141483640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.33|||<|0.0001|TWO_SIDED|95.0|-11.98|-4.67|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Week LOCF||-4.67|-11.98|<0.0001
70986823|NCT00570739|141483641|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.63||||0.2026|TWO_SIDED|95.0|-1.43|6.7|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||6.70|-1.43|0.2026
70986824|NCT00570739|141483641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32||||0.4506|TWO_SIDED|95.0|-2.12|4.75|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||4.75|-2.12|0.4506
70986825|NCT00570739|141483641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81||||0.2609|TWO_SIDED|95.0|-1.35|4.97|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||4.97|-1.35|0.2609
70986826|NCT00570739|141483642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.81|||<|0.0001|TWO_SIDED|95.0|-11.53|-6.08|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||-6.08|-11.53|<0.0001
70986827|NCT00570739|141483642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.94|||<|0.0001|TWO_SIDED|95.0|-10.23|-3.66|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||-3.66|-10.23|<0.0001
70986828|NCT00570739|141483642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.09||||0.0001|TWO_SIDED|95.0|-9.14|-3.05|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||-3.05|-9.14|0.0001
70986829|NCT00570739|141483643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.05||||0.0171|TWO_SIDED|95.0|-0.33|13.99||The P-Value was from the non-parametric ANCOVA stratified by country.|ANCOVA|The median difference was calculated using Hodges-Lehmann point estimate and corresponding 95% CI was constructed using the method of Moses.||Baseline to 8 weeks||13.99|-0.33|0.0171
70986830|NCT00570739|141483643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.71|||<|0.0001|TWO_SIDED|95.0|9.66|25.54||The P-Value was from the non-parametric ANCOVA stratified by country.|ANCOVA|The median difference was calculated using Hodges-Lehmann point estimate and corresponding 95% CI was constructed using the method of Moses.||Baseline to 16 Weeks||25.54|9.66|<0.0001
70986831|NCT00570739|141483643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.62|||<|0.0001|TWO_SIDED|95.0|11.18|25.74||The P-Value was from the non-parametric ANCOVA stratified by country.|ANCOVA|The median difference was calculated using Hodges-Lehmann point estimate and corresponding 95% CI was constructed using the method of Moses.||Baseline to 16 Weeks LOCF||25.74|11.18|<0.0001
70986832|NCT00570739|141483644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.81||||0.0496|TWO_SIDED|95.0|0.0|5.62|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 weeks||5.62|0.0|0.0496
70986833|NCT00570739|141483644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.65||||0.0117|TWO_SIDED|95.0|0.82|6.47|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||6.47|0.82|0.0117
70986834|NCT00570739|141483644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.43||||0.0009|TWO_SIDED|95.0|1.83|7.03|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||7.03|1.83|0.0009
70986835|NCT00570739|141483645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.56|||<|0.0001|TWO_SIDED|95.0|-14.74|-8.38|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||-8.38|-14.74|<0.0001
70986836|NCT00570739|141483645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.53||||0.0001|TWO_SIDED|95.0|-13.14|-5.92|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||-5.92|-13.14|0.0001
70986837|NCT00570739|141483645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.97|||<|0.0001|TWO_SIDED|95.0|-11.35|-4.59|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||-4.59|-11.35|<0.0001
70986838|NCT00570739|141483646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.57||||0.0003|TWO_SIDED|95.0|5.76|19.38|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||19.38|5.76|0.0003
70986839|NCT00570739|141483646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.52||||0.0003|TWO_SIDED|95.0|6.64|22.4|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||22.40|6.64|0.0003
70986840|NCT00570739|141483646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.08|||<|0.0001|TWO_SIDED|95.0|7.95|22.2|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||22.20|7.95|<0.0001
70986841|NCT00570739|141483647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.84||||0.0363|TWO_SIDED|95.0|0.44|13.24||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Very Low Density Lipoprotein (VLDL) Particles||13.24|0.44|0.0363
70986842|NCT00570739|141483647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.39||||0.0347|TWO_SIDED|95.0|0.46|12.31||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Very Low Density Lipoprotein (VLDL) Particles||12.31|0.46|0.0347
70986843|NCT00570739|141483647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.31||||0.0028|TWO_SIDED|95.0|0.8|3.81||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||VLDL Chylomicron Particles||3.81|0.80|0.0028
70986844|NCT00570739|141483647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.34||||0.001|TWO_SIDED|95.0|0.96|3.73||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||VLDL Chylomicron Particles||3.73|0.96|0.0010
70986845|NCT00570739|141483647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.13||||0.0006|TWO_SIDED|95.0|3.1|11.21||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium VLDL Particles||11.21|3.10|0.0006
70986846|NCT00570739|141483647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.13||||0.0003|TWO_SIDED|95.0|3.35|10.91||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium VLDL Particles||10.91|3.35|0.0003
70986847|NCT00570739|141483647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.88||||0.175|TWO_SIDED|95.0|-7.04|1.29||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small VLDL Particles||1.29|-7.04|0.1750
70986848|NCT00570739|141483647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.23||||0.1007|TWO_SIDED|95.0|-7.1|0.63||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small VLDL Particles||0.63|-7.10|0.1007
70986849|NCT00570739|141483647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-199.3|||<|0.0001|TWO_SIDED|95.0|-272.9|-125.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Low Density Lipoprotein (LDL) Particles||-125.8|-272.9|<0.0001
70986850|NCT00570739|141483647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-186.1||||0.0001|TWO_SIDED|95.0|-255.9|-116.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Low Density Lipoprotein (LDL) Particles||-116.3|-255.9|0.0001
70986851|NCT00570739|141483647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.7||||0.0466|TWO_SIDED|95.0|-23.3|-0.2||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Intermediate Density Lipoprotein Particles||-0.2|-23.3|0.0466
70986852|NCT00570739|141483647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.7||||0.057|TWO_SIDED|95.0|-21.8|0.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Intermediate Density Lipoprotein Particles||0.3|-21.8|0.0570
70986853|NCT00570739|141483647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-77.7||||0.0004|TWO_SIDED|95.0|-120.3|-35.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large LDL Particles||-35.0|-120.3|0.0004
71038005|NCT01911429|141583248|SUPERIORITY_OR_OTHER||LS mean difference (SE)|-0.42||||0.0015|TWO_SIDED|95.0|-0.67|-0.16|||LS mean difference (SE)|||LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||-0.16|-0.67|0.0015
71098255|NCT00286455|141704671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.073|||<|0.001|TWO_SIDED|95.0|-0.109|-0.037||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.037|-0.109|<0.001
70986854|NCT00570739|141483647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-69.3||||0.0007|TWO_SIDED|95.0|-109.2|-29.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large LDL Particles||-29.3|-109.2|0.0007
70986855|NCT00570739|141483647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-109.9||||0.0124|TWO_SIDED|95.0|-195.8|-23.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small LDL Particles||-23.9|-195.8|0.0124
71038006|NCT01026402|141583421|SUPERIORITY_OR_OTHER||Maximum Tolerated Dose|50.0|||||||||||||50mg twice daily continuous dosing 20 evaluable patients|||||
71038007|NCT01026402|141583421|SUPERIORITY_OR_OTHER||Maximum Tolerated Dose|100.0|||||||||||||100mg once daily continuous dosing 16 evaluable patients|||||
71038008|NCT01026402|141583421|SUPERIORITY_OR_OTHER||Maximum Tolerated Dose|125.0|||||||||||||125mg twice daily intermittent dosing (2 days on, 5 days off) 29 evaluable patients|||||
71038009|NCT00840203|141583437|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|97.6||||||90.0|88.6|107.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107|88.6|
71038010|NCT00840203|141583438|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|97.3||||||90.0|82.8|114.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||114|82.8|
70986856|NCT00570739|141483647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-106.8||||0.0098|TWO_SIDED|95.0|-187.6|-26.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small LDL Particles||-26.0|-187.6|0.0098
70986857|NCT00570739|141483647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2||||0.102|TWO_SIDED|95.0|-35.6|3.2||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium Small LDL Particles||3.2|-35.6|0.1020
71038011|NCT00840203|141583439|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|94.0||||||90.0|83.0|107.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107|83.0|
70986858|NCT00570739|141483647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.4||||0.0997|TWO_SIDED|95.0|-33.8|3.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium Small LDL Particles||3.0|-33.8|0.0997
70986859|NCT00570739|141483647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-93.7||||0.0069|TWO_SIDED|95.0|-161.6|-25.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Small LDL Particles||-25.9|-161.6|0.0069
70986860|NCT00570739|141483647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-91.4||||0.0052|TWO_SIDED|95.0|-155.2|-27.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Small LDL Particles||-27.5|-155.2|0.0052
70986861|NCT00570739|141483647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94||||0.0524|TWO_SIDED|95.0|-0.01|1.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total High Density Lipoprotein (HDL) Particles||1.90|-0.01|0.0524
70986862|NCT00570739|141483647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01||||0.0301|TWO_SIDED|95.0|0.1|1.91||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total High Density Lipoprotein (HDL) Particles||1.91|0.10|0.0301
70986863|NCT00570739|141483647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.0416|TWO_SIDED|95.0|0.02|0.89||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large HDL Particles||0.89|0.02|0.0416
70986864|NCT00570739|141483647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46||||0.0333|TWO_SIDED|95.0|0.04|0.88||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large HDL Particles||0.88|0.04|0.0333
70986865|NCT00570739|141483647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69||||0.0693|TWO_SIDED|95.0|-0.05|1.44||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium HDL Particles||1.44|-0.05|0.0693
70986866|NCT00570739|141483647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.0187|TWO_SIDED|95.0|0.14|1.56||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium HDL Particles||1.56|0.14|0.0187
70986867|NCT00570739|141483647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.5765|TWO_SIDED|95.0|-1.34|0.75||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small HDL Particles||0.75|-1.34|0.5765
71038012|NCT00840203|141583440|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|98.3||||||90.0|91.5|106.0|||||Metabolite results presented for informational purposes only.|||106|91.5|
71038013|NCT00840203|141583441|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|97.6||||||90.0|86.7|110.0|||||Metabolite results presented for informational purposes only.|||110|86.7|
71038014|NCT00840203|141583442|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|95.6||||||90.0|86.1|106.0|||||Metabolite results presented for informational purposes only.|||106|86.1|
70986868|NCT00570739|141483647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.4762|TWO_SIDED|95.0|-1.35|0.63||P-Value is for the LS Mean Difference between treatment group|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small HDL Particles||0.63|-1.35|0.4762
70986869|NCT00570739|141483648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.21||||0.0652|TWO_SIDED|95.0|-0.14|4.57||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Low Density Lipoprotein Particles||4.57|-0.14|0.0652
70986870|NCT00570739|141483648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.74||||0.0137|TWO_SIDED|95.0|0.57|4.92||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Low Density Lipoprotein Particles||4.92|0.57|0.0137
70986871|NCT00570739|141483648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.4726|TWO_SIDED|95.0|-0.2|0.09||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Low Density Lipoprotien Particles||0.09|-0.20|0.4726
70986872|NCT00570739|141483648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.5715|TWO_SIDED|95.0|-0.17|0.1||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Low Density Lipoprotein Particles||0.10|-0.17|0.5715
70986873|NCT00570739|141483648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.0083|TWO_SIDED|95.0|0.02|0.15||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||High Density Lipoprotein Particles||0.15|0.02|0.0083
70986874|NCT00570739|141483648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.0022|TWO_SIDED|95.0|0.03|0.15||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||High Density Lipoprotein Particles||0.15|0.03|0.0022
70986875|NCT00570739|141483649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.0||||0.0036|TWO_SIDED|95.0|8.6|43.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||43.5|8.6|0.0036
70986876|NCT00570739|141483649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.2||||0.001|TWO_SIDED|95.0|11.2|43.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||43.3|11.2|0.0010
70986877|NCT00570739|141483650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.8||||0.0008|TWO_SIDED|95.0|12.5|47.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||47.0|12.5|0.0008
70986878|NCT00570739|141483650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.7||||0.0002|TWO_SIDED|95.0|14.9|46.6||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||46.6|14.9|0.0002
70986879|NCT00570739|141483651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.0033|TWO_SIDED|95.0|0.9|4.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||4.3|0.9|0.0033
70986880|NCT00570739|141483651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8||||0.0008|TWO_SIDED|95.0|1.2|4.4||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||4.4|1.2|0.0008
70986881|NCT00570739|141483652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.0035|TWO_SIDED|95.0|-0.44|-0.09||P-Value is for the LS mean difference between the treatment groups|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||||-0.09|-0.44|0.0035
70986882|NCT00570739|141483653|SUPERIORITY_OR_OTHER|||||||0.5848||95.0|||||Cochran-Mantel-Haenszel|Stratified by country.||Baseline to 4 Weeks||||0.5848
70986883|NCT00570739|141483653|SUPERIORITY_OR_OTHER|||||||0.8147||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 8 weeks||||0.8147
70986884|NCT00570739|141483653|SUPERIORITY_OR_OTHER|||||||0.4957||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 12 Weeks||||0.4957
70986885|NCT00570739|141483653|SUPERIORITY_OR_OTHER|||||||0.0467||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks||||0.0467
70986886|NCT00570739|141483653|SUPERIORITY_OR_OTHER|||||||0.0589||95.0|||||Cochran-Mantel-Haenszel|Stratified by country.||Baseline to 16 Weeks LOCF||||0.0589
70986887|NCT00570739|141483653|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9||||0.0049|TWO_SIDED|95.0|1.38|6.1|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||6.10|1.38|0.0049
70986888|NCT00570739|141483653|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.44||||0.0092|TWO_SIDED|95.0|1.25|4.76|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||4.76|1.25|0.0092
70986889|NCT00570739|141483654|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||Cochran-Mantel-Haenszel|Startified by country||Baseline to 4 Weeks||||0.0008
70986890|NCT00570739|141483654|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 8 Weeks||||0.0280
71098256|NCT00286455|141704672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045||||0.021|TWO_SIDED|95.0|-0.084|-0.007||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.007|-0.084|0.021
70986891|NCT00570739|141483654|SUPERIORITY_OR_OTHER|||||||0.0414||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 12 Weeks||||0.0414
70986892|NCT00570739|141483654|SUPERIORITY_OR_OTHER|||||||0.084||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks||||0.0840
70986893|NCT00570739|141483654|SUPERIORITY_OR_OTHER|||||||0.0589||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks LOCF||||0.0589
70986894|NCT00570739|141483654|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.0095|TWO_SIDED|95.0|1.21|3.96|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||3.96|1.21|0.0095
70986895|NCT00570739|141483654|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.08||||0.0088|TWO_SIDED|95.0|1.2|3.6|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||3.60|1.20|0.0088
70986896|NCT00570739|141483655|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 8 Weeks||||<0.0001
70986897|NCT00570739|141483655|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks||||<0.0001
70986898|NCT00570739|141483655|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks LOCF||||<0.0001
70986899|NCT00570739|141483655|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.59|||<|0.0001|TWO_SIDED|95.0|2.78|11.23|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||11.23|2.78|<0.0001
70986900|NCT00570739|141483655|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.8|||<|0.0001|TWO_SIDED|95.0|2.53|9.1|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||9.10|2.53|<0.0001
70986901|NCT00570739|141483656|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 8 Weeks||||0.0004
70986902|NCT00570739|141483656|SUPERIORITY_OR_OTHER|||||||0.0326||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks||||0.0326
70986903|NCT00570739|141483656|SUPERIORITY_OR_OTHER|||||||0.0157||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks LOCF||||0.0157
70986904|NCT00570739|141483656|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.49||||0.087|TWO_SIDED|95.0|0.88|7.07|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||7.07|0.88|0.0870
70986905|NCT00570739|141483656|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.86||||0.00439|TWO_SIDED|95.0|1.03|7.94|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||7.94|1.03|0.00439
70986906|NCT00570739|141483657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.7959|TWO_SIDED|95.0|-1.32|1.72||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||1.72|-1.32|0.7959
70986907|NCT00570739|141483657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.8371|TWO_SIDED|95.0|-1.28|1.57||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||1.57|-1.28|0.8371
70986908|NCT00570739|141483658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0033||||0.4584|TWO_SIDED|95.0|-0.0122|0.0055||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||0.0055|-0.0122|0.4584
70986909|NCT00570739|141483658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0035||||0.4039|TWO_SIDED|95.0|-0.0118|0.0048||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||0.0048|-0.0118|0.4039
70986910|NCT00570739|141483659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.59|||<|0.0001|TWO_SIDED|95.0|-21.07|-10.11||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate.||||-10.11|-21.07|<0.0001
70986911|NCT00570739|141483660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.46||||0.2289|TWO_SIDED|95.0|-27.53|6.62||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||6.62|-27.53|0.2289
70986912|NCT00570739|141483660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.54||||0.1997|TWO_SIDED|95.0|-29.22|6.14||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||6.14|-29.22|0.1997
70986913|NCT00570739|141483661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.81||||0.0144|TWO_SIDED|95.0|2.57|23.05||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Calculated Triglycerides||23.05|2.57|0.0144
70986914|NCT00570739|141483661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.12||||0.0037|TWO_SIDED|95.0|4.63|23.61||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Calculated Triglycerides||23.61|4.63|0.0037
70986915|NCT00570739|141483661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.79||||0.006|TWO_SIDED|95.0|6.59|39.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Calculated Very Low Density Lipoprotein Triglycerides||39.00|6.59|0.0060
70986916|NCT00570739|141483661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.72||||0.0013|TWO_SIDED|95.0|9.71|39.73||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Calculated Very Low Density Lipoprotein Triglycerides||39.73|9.71|0.0013
70986917|NCT00570739|141483661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.35||||0.0005|TWO_SIDED|95.0|3.71|13.0|||ANCOVA|||Calculated High Density Lipoprotein-Cholesterol||13.00|3.71|0.0005
70986918|NCT00570739|141483661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.69||||0.0001|TWO_SIDED|95.0|4.27|13.11||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Calculated High Density Lipoprotein-Cholesterol||13.11|4.27|0.0001
70986919|NCT00570739|141483662|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.8804|TWO_SIDED|95.0|0.63|2.34||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||2.34|0.63|0.8804
70986920|NCT00570739|141483662|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.5525|TWO_SIDED|95.0|0.73|2.6||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||2.60|0.73|0.5525
70986921|NCT00570739|141483662|SUPERIORITY_OR_OTHER|||||||0.5648||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.5648
70986922|NCT00570739|141483662|SUPERIORITY_OR_OTHER|||||||0.317||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.3170
70986923|NCT00570739|141483663|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.9008|TWO_SIDED|95.0|0.66|4.06||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||4.06|0.66|0.9008
70986924|NCT00570739|141483663|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.9035|TWO_SIDED|95.0|0.6|3.37||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||3.37|0.60|0.9035
70986925|NCT00570739|141483663|SUPERIORITY_OR_OTHER|||||||0.2874||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.2874
70986926|NCT00570739|141483663|SUPERIORITY_OR_OTHER|||||||0.4344||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.4344
70986927|NCT00570739|141483664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.62|||<|0.0001|TWO_SIDED|95.0|-24.61|-14.63||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||-14.63|-24.61|<0.0001
70986928|NCT00570739|141483664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.47|||<|0.0001|TWO_SIDED|95.0|-23.24|-11.69||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||-11.69|-23.24|<0.0001
70986929|NCT00570739|141483665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.47|||<|0.0001|TWO_SIDED|95.0|-16.26|-8.69||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||-8.69|-16.26|<0.0001
70986930|NCT00570739|141483665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.28|||<|0.0001|TWO_SIDED|95.0|-15.15|-5.41||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||-5.41|-15.15|<0.0001
70986931|NCT00570739|141483665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.06||||0.0002|TWO_SIDED|95.0|-13.69|-4.42||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||-4.42|-13.69|0.0002
70986932|NCT00570739|141483666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.96||||0.0357|TWO_SIDED|95.0|0.27|7.66||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||7.66|0.27|0.0357
71038015|NCT03349567|141583470|SUPERIORITY||Incident rate ratio|0.99||||0.35|TWO_SIDED|95.0|0.98|1.01|||Mixed Models Analysis|Segmented regression analysis was conducted using generalized linear models to estimate change in monthly antimicrobial prescription rates.||||1.01|0.98|0.35
71038016|NCT03349567|141583471|NON_INFERIORITY|A Poisson regression model with log link was used to estimate the rate of safety outcomes. Models were adjusted for time as a continuous covariate, an indicator for month of implementation of intervention (Oct 2018), and included random effects to account for repeated measurements. An interaction variable for the study period (baseline or intervention) and site (intervention or control) was included in the model to estimate the Incident Rate Ratio (IRR) and 95% CIs.|Incident rate ratio|1.12|||||TWO_SIDED|95.0|0.93|1.35||||||||1.35|0.93|
71038017|NCT03349567|141583472|NON_INFERIORITY|A Poisson regression model with log link was used to estimate the rate of safety outcomes. Models were adjusted for time as a continuous covariate, an indicator for month of implementation of intervention (Oct 2018), and included random effects to account for repeated measurements. An interaction variable for the study period (baseline or intervention) and site (intervention or control) was included in the model to estimate the Incident Rate Ratio (IRR) and 95% CIs.|Incident rate ratio|1.01|||||TWO_SIDED|95.0|0.81|1.27||||||||1.27|0.81|
71098257|NCT00286455|141704672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.043|TWO_SIDED|95.0|-0.079|-0.001||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.001|-0.079|0.043
71098258|NCT00286455|141704673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.162|||<|0.001|TWO_SIDED|95.0|-0.255|-0.069||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.069|-0.255|<0.001
70986933|NCT00570739|141483666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||0.6878|TWO_SIDED|95.0|-5.01|3.31||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||3.31|-5.01|0.6878
70986934|NCT00570739|141483666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.7972|TWO_SIDED|95.0|-4.37|3.36||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||3.36|-4.37|0.7972
70986935|NCT00570739|141483667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.91|||<|0.0001|TWO_SIDED|95.0|-12.02|-5.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||-5.80|-12.02|<0.0001
70986936|NCT00570739|141483667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.26|||<|0.0001|TWO_SIDED|95.0|-12.25|-4.26||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||-4.26|-12.25|<0.0001
70986937|NCT00570739|141483667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.23||||0.0002|TWO_SIDED|95.0|-11.03|-3.44||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||-3.44|-11.03|0.0002
70986938|NCT00570739|141483668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.0257|TWO_SIDED|95.0|0.43|6.57||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||6.57|0.43|0.0257
70986939|NCT00570739|141483668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.13||||0.2238|TWO_SIDED|95.0|-1.32|5.58||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||5.58|-1.32|0.2238
70986940|NCT00570739|141483668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.78||||0.2763|TWO_SIDED|95.0|-1.44|4.99||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||4.99|-1.44|0.2763
71038018|NCT03349567|141583473|NON_INFERIORITY|A Poisson regression model with log link was used to estimate the rate of safety outcomes. Models were adjusted for time as a continuous covariate, an indicator for month of implementation of intervention (Oct 2018), and included random effects to account for repeated measurements. An interaction variable for the study period (baseline or intervention) and site (intervention or control) was included in the model to estimate the Incident Rate Ratio (IRR) and 95% CIs.|Incident rate ratio|0.88|||||TWO_SIDED|95.0|0.58|1.34||||||||1.34|0.58|
70986941|NCT00570739|141483669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.83|||<|0.0001|TWO_SIDED|95.0|-13.68|-5.98||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||-5.98|-13.68|<0.0001
70986942|NCT00570739|141483669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.67||||0.0004|TWO_SIDED|95.0|-13.4|-3.94||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||-3.94|-13.40|0.0004
70986943|NCT00570739|141483669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.09||||0.0004|TWO_SIDED|95.0|-12.5|-3.68||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||-3.68|-12.50|0.0004
70986944|NCT00570739|141483670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.8||||0.0007|TWO_SIDED|95.0|5.87|21.74||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||21.74|5.87|0.0007
70986945|NCT00570739|141483670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.58||||0.0901|TWO_SIDED|95.0|-1.83|24.99||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||24.99|-1.83|0.0901
70986946|NCT00570739|141483670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.45||||0.0918|TWO_SIDED|95.0|-1.71|22.62||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a||Baseline to 16 Weeks LOCF||22.62|-1.71|0.0918
70986947|NCT00570739|141483671|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|15.78||||0.0005|TWO_SIDED|95.0|6.27|25.83||P-Value is from the non-parametric ANCOVA stratified by country|ANCOVA|Non-parametric|The median difference was calculated using Hodges-Lehmann point estimates and corresponding 95% confidence interval was constructed using the method of Moses.|Baseline to 8 Weeks||25.83|6.27|0.0005
70986948|NCT00570739|141483671|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|16.07||||0.0011|TWO_SIDED|95.0|6.33|26.02||P-Value is from the non-parametric ANCOVA stratified by country|ANCOVA|Non-parametric|The median difference was calculated using Hodges-Lehmann point estimates and corresponding 95% confidence interval was constructed using the method of Moses.|Baseline to 16 Weeks||26.02|6.33|0.0011
70986949|NCT00570739|141483671|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|14.33||||0.0009|TWO_SIDED|95.0|5.11|23.84||P-Value is from the non-parametric ANCOVA stratified by country|ANCOVA|Non-parametric|The median difference was calculated using Hodges-Lehmann point estimates and corresponding 95% confidence interval was constructed using the method of Moses.|Baseline to 16 Weeks LOCF||23.84|5.11|0.0009
70986950|NCT00570739|141483672|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.29||||0.6523|TWO_SIDED|95.0|-17.5|10.32||P-Value was from the non-parametric ANCOVA stratified by country|ANCOVA|Non-parametric|The median difference was calculated using Hodges-Lehmann point estimates and corresponding 95% confidence interval was constructed using the method of Moses.|Baseline to 16 Weeks||10.32|-17.50|0.6523
70986951|NCT00570739|141483672|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.38||||0.3934|TWO_SIDED|95.0|-17.51|8.77||P-Value was from the non-parametric ANCOVA stratified by country|ANCOVA|Non-parametric|The median difference was calculated using Hodges-Lehmann point estimates and corresponding 95% confidence interval was constructed using the method of Moses.|Baseline to 16 Weeks LOCF||8.77|-17.51|0.3934
71098259|NCT00286455|141704673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.159||||0.001|TWO_SIDED|95.0|-0.254|-0.065||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.065|-0.254|0.001
71098260|NCT00286455|141704674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.086||||0.001|TWO_SIDED|95.0|-0.138|-0.034||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.034|-0.138|0.001
70986952|NCT00570739|141483673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.9838|TWO_SIDED|95.0|-8.66|8.84||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total VLDL Particles||8.84|-8.66|0.9838
70986953|NCT00570739|141483673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.53||||0.7157|TWO_SIDED|95.0|-6.73|9.79||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total VLDL Particles||9.79|-6.73|0.7157
70986954|NCT00570739|141483673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.44|||<|0.0001|TWO_SIDED|95.0|1.25|3.63||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large VLDL Chylomicron Particles||3.63|1.25|<0.0001
71098261|NCT00286455|141704674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.084||||0.002|TWO_SIDED|95.0|-0.137|-0.032||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.032|-0.137|0.002
71098262|NCT00286455|141704675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.216||||0.23|TWO_SIDED|95.0|-0.568|0.137||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.137|-0.568|0.230
70986955|NCT00570739|141483673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.39|||<|0.0001|TWO_SIDED|95.0|1.27|3.51||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large VLDL Chylomicron Particles||3.51|1.27|<0.0001
70986956|NCT00570739|141483673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.04||||0.0577|TWO_SIDED|95.0|-0.17|10.24||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium VLDL Chylomicron Particles||10.24|-0.17|0.0577
70986957|NCT00570739|141483673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.24||||0.039|TWO_SIDED|95.0|0.27|10.22||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium VLDL Chylomicron Particles||10.22|0.27|0.0390
71038019|NCT03349567|141583474|NON_INFERIORITY|A Poisson regression model with log link was used to estimate the rate of safety outcomes. Models were adjusted for time as a continuous covariate, an indicator for month of implementation of intervention (Oct 2018), and included random effects to account for repeated measurements. An interaction variable for the study period (baseline or intervention) and site (intervention or control) was included in the model to estimate the Incident Rate Ratio (IRR) and 95% CIs.|Incident rate ratio|0.83|||||TWO_SIDED|95.0|0.53|1.29||||||||1.29|0.53|
70986958|NCT00570739|141483673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.49||||0.0044|TWO_SIDED|95.0|-12.61|-2.37||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small VLDL Particles||-2.37|-12.61|0.0044
71038020|NCT03349567|141583475|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
71038021|NCT03349567|141583475|SUPERIORITY|||||||0.13|||||||Chi-squared|||||||0.13
71038022|NCT03349567|141583476|SUPERIORITY|||||||0.46|||||||Regression, Logistic|Segmented regression analysis was conducted using generalized linear models to estimate change in monthly antibiotic prescription rates.||||||0.46
71038023|NCT02705716|141583486|OTHER||Least Square (LS) Mean Difference|-0.12||||0.5191|TWO_SIDED|95.0|-0.497|0.252|||ANCOVA|From ANCOVA Model, Response: change from baseline in Schiff sensitivity score Factors: treatment \& site Covariates: baseline Schiff sensitivity score|Difference is first named dentifrice minus second named dentifrice such that a negative difference favors first named dentifrice.|||0.252|-0.497|0.5191
71038024|NCT01395017|141583513|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.3864|TWO_SIDED|95.0|0.85|1.65||The log-rank test was used to test OS. As a sensitivity analysis, HR and its confidence interval was also provided for OS using the Cox proportional hazard model.|Cox proportional hazard model|Adjusting for baseline factors - treatment, ECOG PS, region, CA19-9 level (\< 1000 IU/mL or \>/=1000 IU/mL), and RT during trial (yes or no).||Using a 1-sided alpha=0.2, a population of 200 participants (100 GEM plus dasatinib and 100 GEM plus placebo) has 79% power to show an increase in median OS from 10 to 13.3 months (hazard ratio \[HR\] =0.75, assuming analysis of 135 deaths).||1.65|0.85|0.3864
70922822|NCT04950127|141336688|SUPERIORITY||Mean Difference (Net)|-0.49|||<|0.001|TWO_SIDED|95.0|-0.76|-0.21||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline Concomitant Itch Medication.||-0.21|-0.76|<0.001
70986959|NCT00570739|141483673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.24||||0.0118|TWO_SIDED|95.0|-11.09|-1.4||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small VLDL Particles||-1.40|-11.09|0.0118
70986960|NCT00570739|141483673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-110.6||||0.0293|TWO_SIDED|95.0|-209.9|-11.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Low Density Lipoprotein (LDL) Particles||-11.3|-209.9|0.0293
70986961|NCT00570739|141483673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-112.7||||0.0202|TWO_SIDED|95.0|-207.6|-17.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Low Density Lipoprotein (LDL) Particles||-17.8|-207.6|0.0202
70986962|NCT00570739|141483673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.9629|TWO_SIDED|95.0|-15.2|14.5|||ANCOVA|||Intermediate Density Lipoprotein (LDL) Particles||14.5|-15.2|0.9629
71038025|NCT01395017|141583514|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.6761|TWO_SIDED|95.0|0.73|1.34||The log-rank test was used to test PFS. As a sensitivity analysis, HR and its confidence interval was also provided for PFS using the Cox proportional hazard model.|Cox proportional hazard model|Adjusting for baseline factors: treatment, ECOG PS, region, CA19-9 level (\< 1000 IU/mL or \>/=1000 IU/mL), and RT during trial (yes or no).||Trial has 88% power to show a median PFS increase from 5 to 7 months (with 1-sided alpha=0.15, total 176 events, HR=0.714).||1.34|0.73|0.6761
71038026|NCT00557245|141583606|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33|||<|0.001|TWO_SIDED|95.0|0.19|0.56||The a priori threshold was 0.05.|Regression, Cox||Placebo arm is the reference group.|We used Cox regression stratified according to site, to estimate the relative rates of time to first positive HIV-1 serologic test.||0.56|0.19|<0.001
71038027|NCT00557245|141583606|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.25|||<|0.001|TWO_SIDED|95.0|0.13|0.45||The a priori threshold was 0.05.|Regression, Cox||Placebo arm is the reference group.|We used Cox regression stratified according to site, to estimate the relative rates of time to first positive HIV-1 serologic test.||0.45|0.13|<0.001
70986963|NCT00570739|141483673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.7485|TWO_SIDED|95.0|-16.5|11.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Intermediate Density Lipoprotein (LDL) Particles||11.9|-16.5|0.7485
70986964|NCT00570739|141483673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-63.6||||0.1007|TWO_SIDED|95.0|-139.7|12.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large LDL Particles||12.5|-139.7|0.1007
70986965|NCT00570739|141483673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-63.8||||0.0768|TWO_SIDED|95.0|-134.6|6.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large LDL Particles||6.9|-134.6|0.0768
70986966|NCT00570739|141483673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.7||||0.4143|TWO_SIDED|95.0|-162.7|67.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small LDL Particles||67.3|-162.7|0.4143
70986967|NCT00570739|141483673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.9||||0.402|TWO_SIDED|95.0|-157.1|63.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small LDL Particles||63.3|-157.1|0.4020
70986968|NCT00570739|141483673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6||||0.6378|TWO_SIDED|95.0|-29.1|17.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium Small LDL Particles||17.9|-29.1|0.6378
70986969|NCT00570739|141483673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7||||0.5528|TWO_SIDED|95.0|-29.1|15.6||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium Small LDL Particles||15.6|-29.1|0.5528
70986970|NCT00570739|141483673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.0||||0.373|TWO_SIDED|95.0|-134.8|50.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Small LDL Particles||50.8|-134.8|0.3730
70986971|NCT00570739|141483673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.0||||0.3764|TWO_SIDED|95.0|-129.0|49.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Small LDL Particles||49.0|-129.0|0.3764
70986972|NCT00570739|141483673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9807|TWO_SIDED|95.0|-1.2|1.17||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total High Density Lipoprotein (HDL) Particles||1.17|-1.20|0.9807
70986973|NCT00570739|141483673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.8615|TWO_SIDED|95.0|-1.23|1.03||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total High Density Lipoprotein (HDL) Particles||1.03|-1.23|0.8615
70986974|NCT00570739|141483673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.0364|TWO_SIDED|95.0|0.04|1.14||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large HDL Particles||1.14|0.04|0.0364
70986975|NCT00570739|141483673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56||||0.034|TWO_SIDED|95.0|0.04|1.08||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large HDL Particles||1.08|0.04|0.0340
70986976|NCT00570739|141483673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.6587|TWO_SIDED|95.0|-0.68|1.07||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium HDL Particles||1.07|-0.68|0.6587
70986977|NCT00570739|141483673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.6554|TWO_SIDED|95.0|-0.63|1.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium HDL Particles||1.00|-0.63|0.6554
71038028|NCT00557245|141583607|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
70986978|NCT00570739|141483673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.1957|TWO_SIDED|95.0|-2.06|0.42||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small HDL Particles||0.42|-2.06|0.1957
70986979|NCT00570739|141483673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||0.1622|TWO_SIDED|95.0|-2.03|0.34||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small HDL Particles||0.34|-2.03|0.1622
70986980|NCT00570739|141483674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.99|||<|0.0001|TWO_SIDED|95.0|3.51|8.48||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Low Density Lipoprotein Particles||8.48|3.51|<0.0001
70986981|NCT00570739|141483674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.31|||<|0.0001|TWO_SIDED|95.0|3.0|7.63||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Low Density Lipoprotein Particles||7.63|3.00|<0.0001
70986982|NCT00570739|141483674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.1742|TWO_SIDED|95.0|-0.3|0.05||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Low Density Lipoprotein Particles||0.05|-0.30|0.1742
70986983|NCT00570739|141483674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.187|TWO_SIDED|95.0|-0.28|0.06|||ANCOVA|||Low Density Lipoprotein Particles||0.06|-0.28|0.1870
71038029|NCT00557245|141583607|SUPERIORITY_OR_OTHER|||||||0.89|||||||Fisher Exact|||||||0.89
70986984|NCT00570739|141483674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.0063|TWO_SIDED|95.0|0.03|0.16||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||High Density Lipoprotein Particles||0.16|0.03|0.0063
70986985|NCT00570739|141483674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.002|TWO_SIDED|95.0|0.04|0.16||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||High Density Lipoprotein Particles||0.16|0.04|0.0020
70986986|NCT00570739|141483675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.4||||0.0022|TWO_SIDED|95.0|8.9|39.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes in Calculated Total Triglycerides||39.9|8.9|0.0022
70986987|NCT00570739|141483675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.3||||0.0013|TWO_SIDED|95.0|9.6|39.1||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes in Calculated Total Triglycerides||39.1|9.6|0.0013
70986988|NCT00570739|141483675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.3||||0.0006|TWO_SIDED|95.0|11.5|41.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes: Calculated Very Low Density Triglycerides||41.0|11.5|0.0006
70986989|NCT00570739|141483675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.5||||0.0003|TWO_SIDED|95.0|12.5|40.6||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes: Calculated Very Low Density Triglycerides||40.6|12.5|0.0003
70986990|NCT00570739|141483675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.1257|TWO_SIDED|95.0|-0.4|3.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes in Calculated High Density Lipoprotein-Cholesterol||3.5|-0.4|0.1257
70986991|NCT00570739|141483675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.1054|TWO_SIDED|95.0|-0.3|3.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes in Calculated High Density Lipoprotein-Cholesterol||3.3|-0.3|0.1054
70986992|NCT00570739|141483676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.2971|TWO_SIDED|95.0|-0.11|0.03||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 4 Weeks||0.03|-0.11|0.2971
70986993|NCT00570739|141483676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.2567|TWO_SIDED|95.0|-0.11|0.03||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||0.03|-0.11|0.2567
70986994|NCT00570739|141483676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.1081|TWO_SIDED|95.0|-0.13|0.01||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 12 Weeks||0.01|-0.13|0.1081
70986995|NCT00570739|141483676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.079|TWO_SIDED|95.0|-0.17|0.01||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||0.01|-0.17|0.0790
71038030|NCT00557245|141583611|SUPERIORITY_OR_OTHER|||||||0.24|||||||Regression, Logistic|Generalized estimating equations, with logistic link and robust standard errors to adjust for individual correlation over time.||||||0.24
71038031|NCT00557245|141583611|SUPERIORITY_OR_OTHER|||||||0.49|||||||Regression, Logistic|Generalized estimating equations, with logistic link and robust standard errors to adjust for individual correlation over time.||||||0.49
70986996|NCT00570739|141483676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.0206|TWO_SIDED|95.0|-0.18|-0.01||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||-0.01|-0.18|0.0206
70986997|NCT00570739|141483677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3||||0.0009|TWO_SIDED|95.0|-6.8|-1.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 4 Weeks||-1.8|-6.8|0.0009
70986998|NCT00570739|141483677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.1184|TWO_SIDED|95.0|-4.5|0.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||0.5|-4.5|0.1184
70986999|NCT00570739|141483677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.0615|TWO_SIDED|95.0|-5.8|0.1||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 12 Weeks||0.1|-5.8|0.0615
71038032|NCT00557245|141583612|SUPERIORITY_OR_OTHER|||||||0.32|||||||Regression, Logistic|Generalized estimating equations, logistic link, with robust standard errors.||||||0.32
71038033|NCT00557245|141583612|SUPERIORITY_OR_OTHER|||||||0.66|||||||Regression, Logistic|Generalized estimating equations, logistic link, with robust standard errors.||||||0.66
71038034|NCT00557245|141583613|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||Regression, Logistic|Generalized estimating equations with logistic link to account for multiple pregnancies and multiple births||||||0.51
71038035|NCT00557245|141583613|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Regression, Logistic|generalized estimating equations with logistic link to account for multiple pregnancies and multiple births||||||0.86
71038036|NCT00557245|141583614|SUPERIORITY_OR_OTHER|||||||0.42|||||||Mixed Models Analysis|linear mixed-effects model||||||0.42
71038037|NCT00557245|141583614|SUPERIORITY_OR_OTHER||Slope Difference over time|0.07||||0.08|||||||Mixed Models Analysis|Linear mixed-effects model|Placebo arm is the reference group.|||||0.08
71038038|NCT00557245|141583615|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|Linear mixed effects model||||||0.02
70987000|NCT00570739|141483677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.3617|TWO_SIDED|95.0|-7.2|2.6||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||2.6|-7.2|0.3617
70987001|NCT00570739|141483677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.2372|TWO_SIDED|95.0|-7.0|1.7||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||1.7|-7.0|0.2372
70987002|NCT00570739|141483678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.921||||0.2982|TWO_SIDED|95.0|-0.821|2.663||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 4 Weeks||2.663|-0.821|0.2982
70987003|NCT00570739|141483678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.695||||0.2361|TWO_SIDED|95.0|-0.458|1.848||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||1.848|-0.458|0.2361
70987004|NCT00570739|141483678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.218||||0.0413|TWO_SIDED|95.0|-2.388|-0.049|||ANCOVA|||Baseline to 12 Weeks||-0.049|-2.388|0.0413
70987005|NCT00570739|141483678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.434||||0.7858|TWO_SIDED|95.0|-3.583|2.715|||ANCOVA|||Baseline to 16 Weeks||2.715|-3.583|0.7858
70987006|NCT00570739|141483678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.493||||0.7314|TWO_SIDED|95.0|-3.321|2.335|||ANCOVA|||Baseline to 16 Weeks LOCF||2.335|-3.321|0.7314
70987007|NCT00570739|141483679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.089||||0.553|TWO_SIDED|95.0|-0.385|0.207||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||0.207|-0.385|0.5530
71038039|NCT00557245|141583615|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Linear mixed effects model||||||<0.001
71038040|NCT00557245|141583616|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Mixed Models Analysis|Linear mixed effects model||||||0.35
71038041|NCT00557245|141583616|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Mixed Models Analysis|Linear mixed effects model||||||0.008
71038042|NCT01127087|141583637|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||t-test, 2 sided|||Comparison of Urinary oxalate before and at the end of 4 weeks on Oxazyme in the RYGB Calcium oxalate (CaOx) Stone Formers arm.||||0.027
71038043|NCT01127087|141583637|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||t-test, 2 sided|||Comparison of Urinary oxalate before and at the end of 4 weeks on Oxazyme in the Idiopathic Hyperoxaluria CaOx Stone Formers arm.||||0.14
71038044|NCT01127087|141583638|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||t-test, 2 sided|||Comparison of Oxalate before and at the end of 4 weeks on Oxazyme in the RYGB CaOx Stone Formers arm.||||0.018
71038045|NCT01127087|141583638|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||t-test, 2 sided|||Comparison of Oxalate before and at the end of 4 weeks on Oxazyme in the Idiopathic Hyperoxaluria CaOx Stone Formers arm.||||0.06
71098263|NCT00286455|141704675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.154||||0.393|TWO_SIDED|95.0|-0.508|0.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.200|-0.508|0.393
70987008|NCT00570739|141483679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.105||||0.4554|TWO_SIDED|95.0|-0.383|0.172||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||0.172|-0.383|0.4554
71038046|NCT00521586|141583649|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower limit of the 2-sided 95% CI was greater than -0.1 or -10%|percent difference|2.8|||||TWO_SIDED|95.0|-1.8|7.4||||||A/H1N1 strain: Exact 2-sided, 95 percent (%) confidence intervals was computed based on the methodology by Chan and Zhang||7.4|-1.8|
71038047|NCT00521586|141583649|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower limit of the 2-sided 95% CI was greater than -0.1 or -10%|percent difference|1.6|||||TWO_SIDED|95.0|-3.9|7.2||||||A/H3N2 strain: Exact 2-sided, 95 % confidence intervals was computed based on the methodology by Chan and Zhang.||7.2|-3.9|
71038048|NCT00521586|141583649|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower limit of the 2-sided 95% CI was greater than -0.1 or -10%|percent difference|0.3|||||TWO_SIDED|95.0|-5.6|6.2||||||B strain: Exact 2-sided, 95 % confidence intervals was computed based on the methodology by Chan and Zhang.||6.2|-5.6|
71038049|NCT00521586|141583650|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.74|||||TWO_SIDED|95.0|0.58|0.95||||||Serotype 1: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||0.95|0.58|
71038050|NCT00521586|141583650|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.79|||||TWO_SIDED|95.0|0.66|0.93||||||Serotype 3: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||0.93|0.66|
70987009|NCT00570739|141483680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.8583|TWO_SIDED|95.0|-10.7|8.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||8.9|-10.7|0.8583
70987010|NCT00570739|141483680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.7975|TWO_SIDED|95.0|-10.5|8.1||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||8.1|-10.5|0.7975
70987011|NCT00570739|141483681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.0||||0.233||95.0|-18.5|4.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||4.5|-18.5|0.2330
70987012|NCT00570739|141483681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2||||0.1412|TWO_SIDED|95.0|-19.2|2.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||2.8|-19.2|0.1412
70987013|NCT00570739|141483682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.8192|TWO_SIDED|95.0|-13.7|10.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||10.8|-13.7|0.8192
70987014|NCT00570739|141483682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.7513|TWO_SIDED|95.0|-13.5|9.7||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||9.7|-13.5|0.7513
70987015|NCT00570739|141483683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.91||||0.4301|TWO_SIDED|95.0|-24.156|10.336||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||10.336|-24.156|0.4301
70987016|NCT00570739|141483683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.17||||0.5369|TWO_SIDED|95.0|-21.661|11.321||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||11.321|-21.661|0.5369
70987017|NCT00570739|141483684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.151||||0.7447|TWO_SIDED|95.0|-1.068|0.765||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||0.765|-1.068|0.7447
70987018|NCT00570739|141483684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.029||||0.9476|TWO_SIDED|95.0|-0.853|0.911||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||0.911|-0.853|0.9476
70987019|NCT00570739|141483685|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 8 Weeks||||<0.0001
71038051|NCT00521586|141583650|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.69|||||TWO_SIDED|95.0|0.55|0.87||||||Serotype 4: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||0.87|0.55|
71098264|NCT00286455|141704676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084||||0.703|TWO_SIDED|95.0|-0.348|0.515||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.515|-0.348|0.703
71098265|NCT00286455|141704676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.282||||0.203|TWO_SIDED|95.0|-0.153|0.717||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.717|-0.153|0.203
70987020|NCT00570739|141483685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.23||||0.0018|TWO_SIDED|95.0|2.06|13.58||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||13.58|2.06|0.0018
70987021|NCT00570739|141483685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.46||||0.0019|TWO_SIDED|95.0|1.89|10.54||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||10.54|1.89|0.0019
70987022|NCT00570739|141483685|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.0005
70987023|NCT00570739|141483685|SUPERIORITY_OR_OTHER|||||||0.0007||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.0007
70987024|NCT00570739|141483686|SUPERIORITY_OR_OTHER|||||||0.0104||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 8 Weeks||||0.0104
70987025|NCT00570739|141483686|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.22||||0.2224|TWO_SIDED|95.0|0.53|9.39||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||9.39|0.53|0.2224
70987026|NCT00570739|141483686|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21||||0.199|TWO_SIDED|95.0|0.53|9.33||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||9.33|0.53|0.1990
70987027|NCT00570739|141483686|SUPERIORITY_OR_OTHER|||||||0.2778||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.2778
71098266|NCT00286455|141704677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169||||0.408|TWO_SIDED|95.0|-0.232|0.569||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.569|-0.232|0.408
70987028|NCT00570739|141483686|SUPERIORITY_OR_OTHER|||||||0.2785||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.2785
70987029|NCT00570739|141483687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.5353|TWO_SIDED|95.0|-2.84|1.48||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||1.48|-2.84|0.5353
70987030|NCT00570739|141483687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.5475|TWO_SIDED|95.0|-2.64|1.4||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||1.40|-2.64|0.5475
70987031|NCT00570739|141483688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0116||||0.0678|TWO_SIDED|95.0|-0.0241|0.0009||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||0.0009|-0.0241|0.0678
70987032|NCT00570739|141483688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0112||||0.0585|TWO_SIDED|95.0|-0.0228|0.0004||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||0.0004|-0.0228|0.0585
70987033|NCT00570739|141483689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.7051|TWO_SIDED|95.0|-18.64|12.64||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||12.64|-18.64|0.7051
70987034|NCT00570739|141483689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8||||0.5267|TWO_SIDED|95.0|-19.72|10.13||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||10.13|-19.72|0.5267
70987035|NCT00570739|141483690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.5882|TWO_SIDED|95.0|0.4|1.83||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||1.83|0.40|0.5882
70987036|NCT00570739|141483690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.7098|TWO_SIDED|95.0|0.44|1.96||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||1.96|0.44|0.7098
71038052|NCT00521586|141583650|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.84|||||TWO_SIDED|95.0|0.67|1.05||||||Serotype 5: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.05|0.67|
71038053|NCT00521586|141583650|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.86|||||TWO_SIDED|95.0|0.7|1.06||||||Serotype 6A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.06|0.70|
71038054|NCT00521586|141583650|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.75|||||TWO_SIDED|95.0|0.6|0.93||||||Serotype 6B: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||0.93|0.60|
71038055|NCT00521586|141583650|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.77|||||TWO_SIDED|95.0|0.63|0.95||||||Serotype 7F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||0.95|0.63|
71038056|NCT00521586|141583650|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.71|||||TWO_SIDED|95.0|0.59|0.86||||||Serotype 9V: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution||0.86|0.59|
70987037|NCT00570739|141483690|SUPERIORITY_OR_OTHER|||||||0.6835||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.6835
70987038|NCT00570739|141483690|SUPERIORITY_OR_OTHER|||||||0.8461||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.8461
70987039|NCT00570739|141483691|SUPERIORITY_OR_OTHER|||||||0.2079||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country|Cochran-Mantel-Haenszel|||Baseline to 4 Weeks||||0.2079
70987040|NCT00570739|141483691|SUPERIORITY_OR_OTHER|||||||0.4053||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country|Cochran-Mantel-Haenszel|||Baseline to 8 Weeks||||0.4053
70987041|NCT00570739|141483691|SUPERIORITY_OR_OTHER|||||||0.5752||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country|Cochran-Mantel-Haenszel|||Baseline to 12 Weeks||||0.5752
70987042|NCT00570739|141483691|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.7994|TWO_SIDED|95.0|0.25|2.29||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||2.29|0.25|0.7994
71098267|NCT00286455|141704677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.013||||0.949|TWO_SIDED|95.0|-0.391|0.417||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.417|-0.391|0.949
71098268|NCT00286455|141704678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.886|TWO_SIDED|95.0|-0.44|0.38||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.380|-0.440|0.886
70987043|NCT00570739|141483691|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.996|TWO_SIDED|95.0|0.32|3.03||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||3.03|0.32|0.9960
70987044|NCT00570739|141483691|SUPERIORITY_OR_OTHER|||||||0.7783||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.7783
70987045|NCT00570739|141483691|SUPERIORITY_OR_OTHER|||||||0.9774||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.9774
70987046|NCT00570739|141483692|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 4 Weeks||||<0.0001
70987047|NCT00570739|141483692|SUPERIORITY_OR_OTHER|||||||0.4058||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 8 Weeks||||0.4058
70987048|NCT00570739|141483692|SUPERIORITY_OR_OTHER|||||||0.0254||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 12 Weeks||||0.0254
70987049|NCT00570739|141483692|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.1499|TWO_SIDED|95.0|0.74|3.55||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||3.55|0.74|0.1499
70987050|NCT00570739|141483692|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.08||||0.042|TWO_SIDED|95.0|0.97|4.45||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||4.45|0.97|0.0420
70987051|NCT00570739|141483692|SUPERIORITY_OR_OTHER|||||||0.224||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.2240
70987052|NCT00570739|141483692|SUPERIORITY_OR_OTHER|||||||0.0593||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.0593
71038057|NCT00521586|141583650|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.77|||||TWO_SIDED|95.0|0.6|0.98||||||Serotype 14: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution||0.98|0.60|
71038058|NCT00521586|141583650|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.72|||||TWO_SIDED|95.0|0.58|0.88||||||Serotype 18C: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution||0.88|0.58|
71038059|NCT00521586|141583650|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.89|||||TWO_SIDED|95.0|0.74|1.08||||||Serotype 19A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution||1.08|0.74|
70987053|NCT00570739|141483693|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.4794|TWO_SIDED|95.0|0.31|1.4||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||1.40|0.31|0.4794
70987054|NCT00570739|141483693|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.6667|TWO_SIDED|95.0|0.37|1.55||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||1.55|0.37|0.6667
71038060|NCT00521586|141583650|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.86|||||TWO_SIDED|95.0|0.67|1.1||||||Serotype 19F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution||1.10|0.67|
70987055|NCT00570739|141483693|SUPERIORITY_OR_OTHER|||||||0.2768||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.2768
70987056|NCT00570739|141483693|SUPERIORITY_OR_OTHER|||||||0.4395||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.4395
70987057|NCT00570739|141483694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.43||||0.1375|TWO_SIDED|95.0|0.89|6.64||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||6.64|0.89|0.1375
70987058|NCT00570739|141483694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.22||||0.1996|TWO_SIDED|95.0|0.85|5.82|||Cochran-Mantel-Haenszel|P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.||Baseline to 16 Weeks LOCF||5.82|0.85|0.1996
70987059|NCT00570739|141483694|SUPERIORITY_OR_OTHER|||||||0.0829||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.0829
70987060|NCT00570739|141483694|SUPERIORITY_OR_OTHER|||||||0.1037||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.1037
70987061|NCT01400971|141483700|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.54|0.92||||||Public insurance||0.92|0.54|
70987062|NCT01400971|141483700|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|1.92|||||TWO_SIDED|95.0|1.5|2.46||||||Diabetes support service available||2.46|1.50|
70987063|NCT01400971|141483700|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|1.85|||||TWO_SIDED|95.0|1.38|2.49||||||Baseline HbA1c \> 7.80 (reference:HbA1c≤7.80 median)||2.49|1.38|
70987064|NCT01400971|141483700|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|1.54|||||TWO_SIDED|95.0|1.15|2.07||||||Baseline HbA1c missing (reference:HbA1c≤7.80 median)||2.07|1.15|
70987065|NCT01400971|141483700|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|1.46|||||TWO_SIDED|95.0|1.13|1.88||||||Diabetes duration \> 11 years||1.88|1.13|
70987066|NCT01400971|141483700|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.97|1.0||||||Age (per year increase)||1.00|0.97|
70987067|NCT01400971|141483700|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|10.5|||||TWO_SIDED|95.0|3.3|33.41||||||Baseline insulin therapy: combination||33.41|3.30|
70987068|NCT01400971|141483700|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|5.71|||||TWO_SIDED|95.0|1.77|18.37||||||Baseline insulin therapy: prandial only||18.37|1.77|
70987069|NCT01400971|141483700|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|4.16|||||TWO_SIDED|95.0|3.02|5.73||||||Baseline insulin therapy: pre-mixed only||5.73|3.02|
70987070|NCT01400971|141483700|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy. IPC ranges from 1-5 with higher scores indicating more discrimination.|Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.39|0.65||||||Discrimination domain of the IPC||0.65|0.39|
70987071|NCT01400971|141483700|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy. Diabetes Distress Scale ranges from 1-6 with higher scores indicating more distress.|Odds Ratio (OR)|0.74|||||TWO_SIDED|95.0|0.57|0.95||||||Diabetes Distress Scale total score \> 2||0.95|0.57|
70987072|NCT00455858|141483731|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean|-1.356|||<|0.0001||95.0|-1.368|-1.344|||t-test|||||-1.344|-1.368|<.0001
70987073|NCT00455858|141483732|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean|-1.338|||<|0.0001||95.0|-1.35|-1.327|||t-test|||||-1.327|-1.350|<.0001
70987074|NCT00455858|141483733|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean|-69.553|||<|0.0001||95.0|-70.047|-69.06|||Paired t-test|||Estimated mean decrease in FPG at week 12||-69.060|-70.047|<.0001
70987075|NCT00455858|141483733|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean|-72.159|||<|0.0001||95.0|-72.647|-71.671|||Paired t-test|||Estimated mean decrease in FPG at week 20||-71.671|-72.647|<.0001
70987076|NCT00803244|141483766|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.49||||0.2344||95.0|-1.3|0.32|||ANCOVA|||||0.32|-1.30|0.2344
70987077|NCT00803244|141483767|SUPERIORITY_OR_OTHER||LS Mean difference vs. Placebo|-0.09||||0.0401|TWO_SIDED|95.0|-0.18|0.0|||ANCOVA||Relative LS Means difference (%) = -19.7|||0.00|-0.18|0.0401
70987078|NCT02873715|141483769|SUPERIORITY||Mean Difference (Final Values)|-6.21|||<|0.05|TWO_SIDED|95.0|-10.14|-2.29|||ANCOVA||Results are pooled across 10 multiple imputations and reported as mean (standard error)|||-2.29|-10.14|<0.05
70987079|NCT02873715|141483770|SUPERIORITY||Mean Difference (Final Values)|-3.97||||0.001|TWO_SIDED|95.0|-5.68|-2.26|||ANCOVA||Results are pooled across 10 multiple imputations and reported as mean (standard error)|||-2.26|-5.68|0.001
70987080|NCT02873715|141483772|SUPERIORITY||Mean Difference (Final Values)|-0.5384||||0.65|TWO_SIDED||||||ANOVA|time x group analysis.||repeated measures analysis of variance for parent delay discounting changes from 0 to 24-month. This includes only parents with complete data for both time points and does not exclude based on johnson-bickel rules. Reporting time x group analysis.||||0.65
70987081|NCT02873715|141483772|SUPERIORITY||Mean Difference (Net)|-0.3913||||0.87|TWO_SIDED|||||time x group analysis|ANOVA|||repeated measures analysis of variance for child delay discounting changes from 0 to 24-month. This includes only parents with complete data for both time points and does not exclude based on johnson-bickel rules. Reporting time x group analysis.||||0.87
70987082|NCT01651260|141483797|SUPERIORITY_OR_OTHER||upper probability of failure|0.05||||||||||Minimum sample size of 60 subjects was required based on the ability of the device to perform at an observed level of non-failure equivalent to an expected upper probability of failure not to exceed 5%.|||Minimum sample size of 60 subjects was required based on the ability of the device to perform at an observed level of non-failure equivalent to an expected upper probability of failure not to exceed 5%.|||||
70987083|NCT00053846|141483827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.483|STANDARD_ERROR_OF_MEAN|0.275||0.08|TWO_SIDED|95.0|-1.02|0.0576|||ANCOVA||Multiple Imputation (MI) used for estimates. MICE software in R was used to generate 100 imputed datasets. ANCOVA was run on each, and results were pooled.|H0: The true difference in means is equal to zero. Ha: The true difference in means is not equal to zero.||0.0576|-1.020|0.080
70987084|NCT00064662|141483828|SUPERIORITY_OR_OTHER||Other|0.0||||0.01||95.0|||||Log Rank|||Time to event analysis of 24 month success rates. Null hypothesis is that the distributions in the two groups are equal.||||0.01
70987085|NCT00064662|141483829|SUPERIORITY_OR_OTHER||Chi-square|16.2|||<|0.001||95.0|||||Log Rank|||Time to event analysis of cumulative success rates in the two groups. Null hypothesis is that the distributions are equal in the two groups.||||<0.001
70987086|NCT00064662|141483829|SUPERIORITY_OR_OTHER||Other|0.0|||<|0.0001||95.0|||||Kalpan Meier (Wald statistic)|||Kaplan Meier time-to-event analysis of cumulative success rates. Used Wald test of equality of survival distributions.||||<0.0001
71038061|NCT00521586|141583650|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.84|||||TWO_SIDED|95.0|0.66|1.08||||||Serotype 23F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution||1.08|0.66|
70987087|NCT03008590|141483830|SUPERIORITY|||||||0.9||||||Significance pre-specified at P\<0.05|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.90
70987088|NCT03008590|141483831|SUPERIORITY|||||||0.22||||||Significance pre-specified at P\<0.05|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.22
70987089|NCT03008590|141483832|SUPERIORITY|||||||0.02||||||Although significance was pre-specified at P\<0.05, it is suspected that this result is spurious due to multiple comparisons|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.02
71038062|NCT00521586|141583651|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.83|1.34||||||Serotype 1: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.34|0.83|
71038063|NCT00521586|141583651|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.9|||||TWO_SIDED|95.0|0.75|1.08||||||Serotype 3: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.08|0.75|
71038064|NCT00521586|141583651|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.92|1.28||||||Serotype 4: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.28|0.92|
71038065|NCT00521586|141583651|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.9|||||TWO_SIDED|95.0|0.68|1.08||||||Serotype 5: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.08|0.68|
71038066|NCT00521586|141583651|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.88|1.3||||||Serotype 6A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.30|0.88|
71038067|NCT00521586|141583651|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.84|1.21||||||Serotype 6B: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.21|0.84|
71038068|NCT00521586|141583651|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.9|||||TWO_SIDED|95.0|0.78|1.06||||||Serotype 7F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.06|0.78|
71038069|NCT00521586|141583651|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.2|||||TWO_SIDED|95.0|0.93|1.48||||||Serotype 9V: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.48|0.93|
71038070|NCT00521586|141583651|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.86|1.17||||||Serotype 14: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.17|0.86|
71038071|NCT00521586|141583651|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.84|1.27||||||Serotype 18C: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.27|0.84|
71038072|NCT00521586|141583651|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.87|1.21||||||Serotype 19A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.21|0.87|
71038073|NCT00521586|141583651|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.85|1.31||||||Serotype 19F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.31|0.85|
71038074|NCT00521586|141583651|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.8|1.27||||||Serotype 23F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.27|0.80|
70987090|NCT03008590|141483833|SUPERIORITY|||||||0.3||||||Significance pre-specified at P\<0.05|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.3
70987091|NCT03008590|141483834|SUPERIORITY|||||||0.04||||||Although significance was pre-specified at P\<0.05, it is suspected that this result is spurious due to multiple comparisons|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.04
70987092|NCT03008590|141483835|SUPERIORITY|||||||0.78||||||Significance pre-specified at P\<0.05|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.78
70987093|NCT03008590|141483836|SUPERIORITY|||||||0.92||||||Significance pre-specified at P\<0.05|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.92
70987094|NCT00872833|141483843|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<.001
70987095|NCT00872833|141483844|SUPERIORITY_OR_OTHER|||||||0.028|||||||Chi-squared|||||||0.028
70987096|NCT01417780|141483865|OTHER|||||||0.016|||||||ANOVA|||||||0.016
70987097|NCT01417780|141483866|OTHER|||||||0.019|||||||Chi-squared|||The null hypothesis was that the frequency of Day 14 SOFA score less than or equal to 1 was not different among treatment groups.||||0.019
70987098|NCT01417780|141483867|OTHER|||||||0.11||||||Wilcoxon p value represents comparison of active dose groups versus placebo group.|Wilcoxon (Mann-Whitney)|||||||0.11
71038075|NCT00521586|141583660|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.01|||||TWO_SIDED|95.0|0.87|1.18||||||Serotype 1: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.18|0.87|
71038076|NCT00521586|141583660|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.95|||||TWO_SIDED|95.0|0.82|1.1||||||Serotype 3: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.10|0.82|
71038077|NCT00521586|141583660|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.03|||||TWO_SIDED|95.0|0.88|1.21||||||Serotype 4: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.21|0.88|
70987099|NCT01417780|141483868|OTHER|||||||0.18||||||Wilcoxon p value represents comparison of active dose groups versus placebo group.|Wilcoxon (Mann-Whitney)|||||||0.18
70987100|NCT01417780|141483869|OTHER|||||||0.19||||||Wilcoxon p value represents comparison of active dose groups versus placebo group.|Wilcoxon (Mann-Whitney)|||||||0.19
70987101|NCT01345786|141483870|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|137.5||||||90.0|131.0|144.4|||||Commercial Batch Test / Phase 3 Batch Reference.|||144.4|131|
70987102|NCT01345786|141483870|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|111.8||||||90.0|107.5|116.4|||||Commercial Batch Test / Phase 3 Batch Reference.|||116.4|107.5|
70987103|NCT01345786|141483871|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|107.3||||||90.0|99.0|116.4|||||Commercial Batch Test / Phase 3 Batch Reference.|||116.4|99|
70987104|NCT01345786|141483871|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|103.6||||||90.0|99.2|108.2|||||"Commercial Batch Test / Phase 3 Batch Reference.~In addition to the participants/profiles excluded, 1 participant from the Phase 3 Batch Reference group did not contribute to this comparison."|||108.2|99.2|
70987105|NCT01345786|141483872|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|110.0||||||90.0|106.4|113.7|||||Commercial Batch Test / Phase 3 Batch Reference.|Analysis for AUClast||113.7|106.4|
70987106|NCT01345786|141483872|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|103.3||||||90.0|100.9|105.7|||||Commercial Batch Test / Phase 3 Batch Reference|Analysis for AUC last||105.7|100.9|
70987107|NCT01345786|141483872|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|108.1||||||90.0|104.7|111.6|||||Commercial Batch Test / Phase 3 Batch Reference.|Analysis for AUC infinity||111.6|104.7|
70987108|NCT01345786|141483872|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|103.1||||||90.0|100.5|105.8|||||Commercial Batch Test / Phase 3 Batch Reference|Analysis for AUC infinity||105.8|100.5|
70987109|NCT01345786|141483873|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|101.5||||||90.0|96.7|106.4|||||Commercial Batch Test / Phase 3 Batch Reference.|||106.4|96.7|
70987110|NCT01345786|141483873|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|101.3||||||90.0|98.1|104.7|||||"Commercial Batch Test / Phase 3 Batch Reference.~In addition to the participants/profiles excluded, 1 participant from the Phase 3 Batch Reference group did not contribute to this comparison."|||104.7|98.1|
70987111|NCT01929044|141483880|NON_INFERIORITY_OR_EQUIVALENCE|One-sided test relative to the non-inferiority margin of 1|Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-0.88|0.04|||Mixed Models Analysis|Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.|Restricted maximum likelihood (REML) -repeated measures approach||0.04|-0.88|<0.0001
70987112|NCT01929044|141483880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.23||0.0743|TWO_SIDED|95.0|-0.88|0.04|||Mixed Models Analysis|Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.|||0.04|-0.88|0.0743
70987113|NCT01929044|141483881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.2||0.121|TWO_SIDED|95.0|-0.7|0.08|||Mixed Models Analysis|Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.|||0.08|-0.70|0.1210
70987114|NCT01929044|141483882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0658|TWO_SIDED|95.0|-0.82|0.03|||Mixed Models Analysis|Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.|||0.03|-0.82|0.0658
70987115|NCT01929044|141483883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.2||0.022|TWO_SIDED|95.0|-0.85|-0.07|||Mixed Models Analysis|Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.|||-0.07|-0.85|0.0220
70987116|NCT01929044|141483884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.0149|TWO_SIDED|95.0|-0.81|-0.09|||Mixed Models Analysis|Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.|||-0.09|-0.81|0.0149
70987117|NCT01929044|141483885|SUPERIORITY_OR_OTHER|||||||0.0113|||||||van Elteren test|The van Elteren test stratifying for centre (Cochran-Mantel-Haenszel test using modified ridit scores) was performed.||||||0.0113
70987118|NCT01929044|141483886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.0992|TWO_SIDED|95.0|0.37|1.09|||Regression, Logistic|A logistic regression model was used to evaluate the response with treatment as fixed effect and baseline pain intensity as continuous covariate.|Exact 95% confidence interval obtained by Clopper and Pearson approach.|||1.09|0.37|0.0992
70987119|NCT04436510|141483887|SUPERIORITY||Disease Rate Ratio|0.98|STANDARD_DEVIATION|0.118|||TWO_SIDED|95.0|0.769|1.237||Posterior probability that the disease rate ratio (DRR) is less than 1 (i.e. verdiperstat slowed progression) was 0.57467. NOTE: p-value is not provided for Bayesian model.|Bayesian shared-parameter model|A Bayesian shared-parameter model of change in disease severity as measured by ALSFRS-R total score and mortality.|"DDR \<1 imply slowing of disease progression by verdiperstat relative to placebo. Note: reported Confidence Interval is actually a Bayesian credible interval."||The model includes covariates for baseline use of edaravone, baseline use of riluzole, months since onset of symptoms, and pre-baseline slope of ALSFRS-R, and random effects for regimen and participant-specific slopes.|1.237|0.769|
70987120|NCT04436510|141483889|SUPERIORITY||Mean Difference (Net)|0.29|STANDARD_ERROR_OF_MEAN|2.054||0.8875|TWO_SIDED|95.0|-3.74|4.32|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Verdiperstat 24-week change from baseline relative to placebo 24-week change from baseline.|||4.32|-3.74|0.8875
71038078|NCT00521586|141583660|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.8|1.09||||||Serotype 5: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.09|0.80|
70987121|NCT04436510|141483890|SUPERIORITY||Mean Difference (Net)|3.57|STANDARD_ERROR_OF_MEAN|3.848||0.3538|TWO_SIDED|95.0|-3.99|11.13|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Verdiperstat 24-week change from baseline relative to placebo 24-week change from baseline.|||11.13|-3.99|0.3538
70987122|NCT04436510|141483891|SUPERIORITY|||||||0.318|||||||Log Rank|||||||0.318
71038079|NCT00521586|141583660|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.01|||||TWO_SIDED|95.0|0.84|1.22||||||Serotype 6A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.22|0.84|
70987123|NCT01663740|141484002|SUPERIORITY_OR_OTHER||Mean Difference|-40.166|STANDARD_ERROR_OF_MEAN|14.1387||0.0075|TWO_SIDED|95.0|-68.869|-11.463|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm density,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in sperm density from Baseline to EOT|||-11.463|-68.869|0.0075
70987124|NCT01663740|141484003|SUPERIORITY_OR_OTHER||Mean Difference|1.758|STANDARD_ERROR_OF_MEAN|2.646||0.5109|TWO_SIDED|95.0|-3.619|7.135|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline TUNEL score,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in TUNEL score from Baseline to EOT|||7.135|-3.619|0.5109
70987125|NCT01663740|141484003|SUPERIORITY_OR_OTHER||Mean Difference|-1.051|STANDARD_ERROR_OF_MEAN|3.2058||0.7449|TWO_SIDED|95.0|-7.566|5.464|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline TUNEL score,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in TUNEL score from Baseline to end of FU|||5.464|-7.566|0.7449
70987126|NCT01663740|141484004|SUPERIORITY_OR_OTHER||Mean Difference|2.869|STANDARD_ERROR_OF_MEAN|3.2934||0.394|TWO_SIDED|95.0|-4.001|9.739|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline TUNEL score,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in TUNEL score from EOT to end of FU|||9.739|-4.001|0.3940
70987127|NCT01663740|141484005|SUPERIORITY_OR_OTHER||Mean Difference|0.155|STANDARD_ERROR_OF_MEAN|0.3687||0.6773|TWO_SIDED|95.0|-0.594|0.903|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline semen volume,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in seminal volume from Basline to EOT|||0.903|-0.594|0.6773
70987128|NCT01663740|141484005|SUPERIORITY_OR_OTHER||Mean Difference|-0.128|STANDARD_ERROR_OF_MEAN|0.3343||0.7046|TWO_SIDED|95.0|-0.806|0.551|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline semen volume,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in seminal volume from Baseline to end of FU|||0.551|-0.806|0.7046
70987129|NCT01663740|141484006|SUPERIORITY_OR_OTHER||Mean Difference|-0.128|STANDARD_ERROR_OF_MEAN|0.3684||0.7323|TWO_SIDED|95.0|-0.888|0.633|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline semen volume,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in seminal volume from EOT to end of FU|||0.633|-0.888|0.7323
70987130|NCT01663740|141484007|SUPERIORITY_OR_OTHER||Mean Difference|51.267|STANDARD_ERROR_OF_MEAN|36.6869||0.1756|TWO_SIDED|95.0|-24.626|127.159|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm density,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in sperm density from EOT to end of FU|||127.159|-24.626|0.1756
70987131|NCT01663740|141484008|SUPERIORITY_OR_OTHER||Mean Difference|-10.195|STANDARD_ERROR_OF_MEAN|19.5745||0.6058|TWO_SIDED|95.0|-49.934|29.543|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm density,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in sperm density from Baseline to end of FU|||29.543|-49.934|0.6058
71038080|NCT00521586|141583660|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.77|1.12||||||Serotype 6B: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.12|0.77|
70987132|NCT01663740|141484009|SUPERIORITY_OR_OTHER||Mean Difference|-21.828|STANDARD_ERROR_OF_MEAN|9.1214||0.0222|TWO_SIDED|95.0|-40.346|-3.311|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm motility,age,duration of pre-transplant dialysis as explanatory variables.|Change in total motility of sperm from Baseline to EOT|||-3.311|-40.346|0.0222
70987133|NCT01663740|141484009|SUPERIORITY_OR_OTHER||Mean Difference|-9.802|STANDARD_ERROR_OF_MEAN|8.3702||0.2495|TWO_SIDED|95.0|-26.795|7.19|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm motility,age,duration of pre-transplant dialysis as explanatory variables.|Change in total motility of sperm from Baseline to end of FU|||7.190|-26.795|0.2495
70987134|NCT01663740|141484010|SUPERIORITY_OR_OTHER||Mean Difference|-11.683|STANDARD_ERROR_OF_MEAN|12.2576||0.3505|TWO_SIDED|95.0|-37.039|13.674|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm motility,age,duration of pre-transplant dialysis as explanatory variables.|Change in total motility of sperm from EOT to end of FU|||13.674|-37.039|0.3505
70987135|NCT01663740|141484011|SUPERIORITY_OR_OTHER||Mean Difference|-5.741|STANDARD_ERROR_OF_MEAN|6.7578||0.4021|TWO_SIDED|95.0|-19.524|8.042|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm morphology,age,pre-transplant dialysis duration as explanatory variables.|Change in sperm morphology from Baseline to EOT|||8.042|-19.524|0.4021
71038081|NCT00521586|141583660|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.11||||||Serotype 7F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.11|0.85|
71038082|NCT00521586|141583660|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.81|1.07||||||Serotype 9V: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.07|0.81|
71038083|NCT00521586|141583660|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.95|||||TWO_SIDED|95.0|0.81|1.11||||||Serotype 14: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.11|0.81|
70987136|NCT01663740|141484011|SUPERIORITY_OR_OTHER||Mean Difference|-1.854|STANDARD_ERROR_OF_MEAN|5.1817||0.7229|TWO_SIDED|95.0|-12.423|8.714|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm morphology,age,pre-transplant dialysis duration as explanatory variables.|Change in sperm morphology from Baseline to end of FU|||8.714|-12.423|0.7229
70987137|NCT01663740|141484012|SUPERIORITY_OR_OTHER||Mean Difference|-2.95|STANDARD_ERROR_OF_MEAN|7.7598||0.708|TWO_SIDED|95.0|-19.192|13.291|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm morphology,age,pre-transplant dialysis duration as explanatory variables.|Change in sperm morphology from EOT to end of FU|||13.291|-19.192|0.7080
70987138|NCT01663740|141484013|SUPERIORITY_OR_OTHER||Mean Difference|-1.861|STANDARD_ERROR_OF_MEAN|1.6512||0.2673|TWO_SIDED|95.0|-5.213|1.491|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline testosterone,age,duration of pre-transplant dialysis as explanatory variables.|Change in total testosterone level from Baseline to EOT|||1.491|-5.213|0.2673
70987139|NCT01663740|141484013|SUPERIORITY_OR_OTHER||Mean Difference|-1.114|STANDARD_ERROR_OF_MEAN|1.6147||0.4949|TWO_SIDED|95.0|-4.392|2.164|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline testosterone,age,duration of pre-transplant dialysis as explanatory variables.|Change in total testosterone level from Baseline to end of FU|||2.164|-4.392|0.4949
70987140|NCT01663740|141484014|SUPERIORITY_OR_OTHER||Mean Difference|0.047|STANDARD_ERROR_OF_MEAN|1.51||0.9753|TWO_SIDED|95.0|-3.063|3.157|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline testosterone,age,duration of pre-transplant dialysis as explanatory variables.|Change in total testosterone level from EOT to end of FU|||3.157|-3.063|0.9753
71038084|NCT00521586|141583660|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.92|||||TWO_SIDED|95.0|0.79|1.06||||||Serotype 18C: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.06|0.79|
71038085|NCT00521586|141583660|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.8|1.08||||||Serotype 19A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.08|0.80|
71038086|NCT00521586|141583660|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.77|1.12||||||Serotype 19F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.12|0.77|
71038087|NCT00521586|141583660|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.9|||||TWO_SIDED|95.0|0.74|1.09||||||Serotype 23F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.09|0.74|
71098269|NCT00286455|141704678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.097||||0.645|TWO_SIDED|95.0|-0.51|0.317||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.317|-0.510|0.645
71098270|NCT00286455|141704679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.656|TWO_SIDED|95.0|-0.378|0.239||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.239|-0.378|0.656
71098271|NCT00286455|141704679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.036||||0.819|TWO_SIDED|95.0|-0.347|0.275||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.275|-0.347|0.819
71098272|NCT00286455|141704680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.079||||0.642|TWO_SIDED|95.0|-0.411|0.253||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.253|-0.411|0.642
71098273|NCT00286455|141704680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003||||0.986|TWO_SIDED|95.0|-0.332|0.338||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.338|-0.332|0.986
71098274|NCT00286455|141704681|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.686||||0.305|TWO_SIDED|95.0|0.622|4.571|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||4.571|0.622|0.305
71098275|NCT00286455|141704681|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.349||||0.091|TWO_SIDED|95.0|0.873|6.321|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||6.321|0.873|0.091
70987141|NCT01663740|141484015|SUPERIORITY_OR_OTHER||Mean Difference|0.076|STANDARD_ERROR_OF_MEAN|0.6347||0.9053|TWO_SIDED|95.0|-1.214|1.366|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline LH concentration,age,pre-transplant dialysis duration as explanatory variables.|Change in LH level from Baseline to EOT|||1.366|-1.214|0.9053
70987142|NCT01663740|141484015|SUPERIORITY_OR_OTHER||Mean Difference|-1.215|STANDARD_ERROR_OF_MEAN|0.4477||0.0104|TWO_SIDED|95.0|-2.125|-0.305|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline LH concentration,age,pre-transplant dialysis duration as explanatory variables.|Change in LH level from Baseline to end of FU|||-0.305|-2.125|0.0104
70987143|NCT01663740|141484016|SUPERIORITY_OR_OTHER||Mean Difference|-1.065|STANDARD_ERROR_OF_MEAN|0.4057||0.0143|TWO_SIDED|95.0|-1.899|-0.231|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline LH concentration,age,\& pre-transplant dialysis duration as explanatory variables.|Change in LH level from EOT to end of FU|||-0.231|-1.899|0.0143
70987144|NCT01663740|141484017|SUPERIORITY_OR_OTHER||Mean Difference|2.541|STANDARD_ERROR_OF_MEAN|1.7274||0.1505|TWO_SIDED|95.0|-0.969|6.052|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline FSH concentration,age,pre-transplant dialysis duration as explanatory variables.|Change in FSH level from Baseline to EOT|||6.052|-0.969|0.1505
70987145|NCT01663740|141484017|SUPERIORITY_OR_OTHER||Mean Difference|-0.983|STANDARD_ERROR_OF_MEAN|0.6739||0.1539|TWO_SIDED|95.0|-2.352|0.387|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline FSH concentration,age,pre-transplant dialysis duration as explanatory variables.|Change in FSH level from Baseline to end of FU|||0.387|-2.352|0.1539
70987146|NCT01663740|141484018|SUPERIORITY_OR_OTHER||Mean Difference|-1.474|STANDARD_ERROR_OF_MEAN|0.8084||0.0798|TWO_SIDED|95.0|-3.136|0.188|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline FSH concentration,age,pre-transplant dialysis duration as explanatory variables.|Change in FSH level from EOT to end of FU|||0.188|-3.136|0.0798
70987147|NCT01663740|141484019|SUPERIORITY_OR_OTHER||Mean Difference|-0.104|STANDARD_ERROR_OF_MEAN|23.466||0.9965|TWO_SIDED|95.0|-47.792|47.585|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline prolactin level,age,pre-transplant dialysis duration as explanatory variables.|Change in prolactin level from Baseline to EOT|||47.585|-47.792|0.9965
70987148|NCT01663740|141484019|SUPERIORITY_OR_OTHER||Mean Difference|15.272|STANDARD_ERROR_OF_MEAN|20.6031||0.4636|TWO_SIDED|95.0|-26.599|57.142|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline prolactin level,age,pre-transplant dialysis duration as explanatory variables.|Change in prolactin level from Baseline to end of FU|||57.142|-26.599|0.4636
70987149|NCT01663740|141484020|SUPERIORITY_OR_OTHER||Mean Difference|8.74|STANDARD_ERROR_OF_MEAN|17.0805||0.6134|TWO_SIDED|95.0|-26.438|43.917|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline prolactin level,age,pre-transplant dialysis duration as explanatory variables.|Change in prolactin level from EOT to end of FU|||43.917|-26.438|0.6134
70987150|NCT01663740|141484021|SUPERIORITY_OR_OTHER||Mean Difference|8.142|STANDARD_ERROR_OF_MEAN|11.9301||0.5002|TWO_SIDED|95.0|-16.223|32.506|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline inhibin B level,age,pre-transplant dialysis duration as explanatory variables.|Change in inhibin B level from Baseline to EOT|||32.506|-16.223|0.5002
70987151|NCT01663740|141484021|SUPERIORITY_OR_OTHER||Mean Difference|40.682|STANDARD_ERROR_OF_MEAN|17.6084||0.0279|TWO_SIDED|95.0|4.72|76.643|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline inhibin B level,age,pre-transplant dialysis duration as explanatory variables.|Change in inhibin B level from Baseline to end of FU|||76.643|4.720|0.0279
71038088|NCT00828321|141583698|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|94.16||||||90.0|85.08|104.21|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104.21|85.08|
71038089|NCT00828321|141583699|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.22||||||90.0|96.21|108.6|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.6|96.21|
71098276|NCT00286455|141704682|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.704||||0.001|TWO_SIDED|95.0|1.694|8.1|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||8.100|1.694|0.001
71098277|NCT00286455|141704682|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.305||||0.003|TWO_SIDED|95.0|1.505|7.255|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||7.255|1.505|0.003
71098278|NCT00286455|141704683|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.905||||0.006|TWO_SIDED|95.0|1.359|6.21|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||6.210|1.359|0.006
71098279|NCT00286455|141704683|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.552|||<|0.001|TWO_SIDED|95.0|2.068|10.017|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||10.017|2.068|<0.001
70987152|NCT01663740|141484022|SUPERIORITY_OR_OTHER||Mean Difference|25.881|STANDARD_ERROR_OF_MEAN|22.1348||0.2548|TWO_SIDED|95.0|-20.024|71.786|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline inhibin B level,age,pre-transplant dialysis duration as explanatory variables|Change in inhibin B level from EOT to end of FU|||71.786|-20.024|0.2548
70987153|NCT01663740|141484023|SUPERIORITY_OR_OTHER||Difference in Percentage|14.3|||||TWO_SIDED|95.0|-19.3|45.3|||||Change in abnormal to abnormal sperm density from Baseline to EOT|||45.3|-19.3|
70987154|NCT01663740|141484023|SUPERIORITY_OR_OTHER||Difference in Percentage|5.0|||||TWO_SIDED|95.0|-34.3|43.3|||||Change in abnormal to abnormal sperm density from Baseline to end of FU|||43.3|-34.3|
70987155|NCT01663740|141484023|SUPERIORITY_OR_OTHER||Difference in Percentage|17.9|||||TWO_SIDED|95.0|-15.3|48.8|||||Change in normal to abnormal sperm density from Baseline to EOT|||48.8|-15.3|
70987156|NCT01663740|141484024|SUPERIORITY_OR_OTHER||Difference in Percentage|4.1|||||TWO_SIDED|95.0|-34.5|42.5|||||Change in abnormal to abnormal sperm density from EOT to end of FU|||42.5|-34.5|
70987157|NCT01663740|141484025|SUPERIORITY_OR_OTHER||Difference in Percentage|1.3|||||TWO_SIDED|95.0|-31.3|33.7|||||Improvement from Baseline to EOT|||33.7|-31.3|
70987158|NCT01663740|141484025|SUPERIORITY_OR_OTHER||Difference in Percentage|6.7|||||TWO_SIDED|95.0|-31.1|44.4|||||Improvement from Baseline to end of FU|||44.4|-31.1|
70987159|NCT01663740|141484026|SUPERIORITY_OR_OTHER||Difference in Percentage|-11.8|||||TWO_SIDED|95.0|-50.0|29.3|||||Improvement from EOT to end of FU|||29.3|-50.0|
70987160|NCT01663740|141484027|SUPERIORITY_OR_OTHER||Difference in Percentage|-31.0|||||TWO_SIDED|95.0|-59.7|2.7|||||Improvement from Baseline to EOT|||2.7|-59.7|
70987161|NCT01663740|141484027|SUPERIORITY_OR_OTHER||Difference in Percentage|10.0|||||TWO_SIDED|95.0|-29.7|47.7|||||Improvement from Baseline to end of FU|||47.7|-29.7|
70987162|NCT01663740|141484028|SUPERIORITY_OR_OTHER||Difference in Percentage|-9.9|||||TWO_SIDED|95.0|-47.2|27.9|||||Improvement from EOT to end of FU|||27.9|-47.2|
70987163|NCT02574312|141484063|NON_INFERIORITY|Non-Inferiority Analysis of absolute value of mechanical axis alignment with NI margin of 1.5 degrees, using a 1-sided T-test with alpha of 0.05. Anticipated power was 95%.||||||0.028|||||||t-test, 1 sided|||||||0.028
70987164|NCT03151148|141484128|SUPERIORITY||Risk Ratio (RR)|0.56||||0.075|TWO_SIDED|95.0|0.29|1.06|||Negative Binomial Regression|Negative binomial generalized linear model, adjusting for site, offset by follow-up days within the outcome measure time frame|TMT represents the numerator, placebo represents the denominator|||1.06|0.29|0.075
70987165|NCT03151148|141484129|SUPERIORITY||Risk Difference (RD)|-0.28||||0.044|TWO_SIDED|95.0|-0.51|-0.04|||Chi-squared||95% exact unconditional confidence interval is based on the Santner and Snell method|||-0.04|-0.51|0.044
70987166|NCT03151148|141484130|SUPERIORITY||Risk Ratio (RR)|0.63||||0.121|TWO_SIDED|95.0|0.36|1.13|||Negative Binomial Regression|Negative binomial generalized linear model, adjusting for site, offset by follow-up days within the outcome measure time frame|TMT represents the numerator, placebo represents the denominator|||1.13|0.36|0.121
70987167|NCT03151148|141484131|SUPERIORITY||Risk Difference (RD)|-0.25||||0.053|TWO_SIDED|95.0|-0.46|-0.04|||Chi-squared||95% exact unconditional confidence interval is based on the Santner and Snell method|||-0.04|-0.46|0.053
70987168|NCT03151148|141484136|SUPERIORITY||Geometric mean ratio (GMR)|2.76||||0.261|TWO_SIDED|95.0|0.469|16.226|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||16.226|0.469|0.261
71098280|NCT00286455|141704684|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.663||||0.004|TWO_SIDED|95.0|1.367|5.188|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||5.188|1.367|0.004
70987169|NCT03151148|141484136|SUPERIORITY||Geometric mean ratio (GMR)|0.41||||0.319|TWO_SIDED|95.0|0.069|2.393|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.393|0.069|0.319
71098281|NCT00286455|141704684|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.277|||<|0.001|TWO_SIDED|95.0|1.671|6.429|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||6.429|1.671|<0.001
71098282|NCT00286455|141704685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.331||||0.002|TWO_SIDED|95.0|1.714|10.947|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||10.947|1.714|0.002
71098283|NCT00286455|141704685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.732||||0.001|TWO_SIDED|95.0|1.862|12.025|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||12.025|1.862|0.001
71098284|NCT00286455|141704686|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.766||||0.153|TWO_SIDED|95.0|0.685|11.16|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||11.160|0.685|0.153
71008825|NCT02055976|141525259|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-65.06617|STANDARD_ERROR_OF_MEAN|3.82052|<|0.001|TWO_SIDED|95.0|-72.65818|-57.47415|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-57.47415|-72.65818|<0.001
71098285|NCT00286455|141704686|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.632||||0.029|TWO_SIDED|95.0|1.169|18.354|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||18.354|1.169|0.029
71098286|NCT00286455|141704687|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||No multiplicity adjustments.|Mantel Haenszel|Odd's Ratio and 95% CI not estimable using logistic regression model. Tested using extended Mantel-Haenszel test.||||||0.102
71098287|NCT00286455|141704687|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||No multiplicity adjustments.|Mantel Haenszel|Odd's Ratio and 95% CI not estimable using logistic regression model. Tested using extended Mantel-Haenszel test.||||||0.063
71098288|NCT00286455|141704688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.186|TWO_SIDED|95.0|-0.18|0.93||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.93|-0.18|0.186
71098289|NCT00286455|141704688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.237|TWO_SIDED|95.0|-0.22|0.89||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.89|-0.22|0.237
71098290|NCT00286455|141704689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.702|TWO_SIDED|95.0|-0.74|0.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.50|-0.74|0.702
71098291|NCT00286455|141704689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.338|TWO_SIDED|95.0|-0.32|0.93||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.93|-0.32|0.338
71098292|NCT00286455|141704690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.978|TWO_SIDED|95.0|-0.74|0.72||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.72|-0.74|0.978
71098293|NCT00286455|141704690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.991|TWO_SIDED|95.0|-0.73|0.74||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.74|-0.73|0.991
71098294|NCT00286455|141704691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.539|TWO_SIDED|95.0|-1.16|0.61||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.61|-1.16|0.539
71098295|NCT00286455|141704691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.379|TWO_SIDED|95.0|-1.29|0.49||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.49|-1.29|0.379
71098296|NCT00286455|141704692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.616|TWO_SIDED|95.0|-4.4|7.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.5|-4.4|0.616
71098297|NCT00286455|141704692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.93|TWO_SIDED|95.0|-6.4|5.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.8|-6.4|0.930
71098298|NCT00286455|141704693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.915|TWO_SIDED|95.0|-5.3|6.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.0|-5.3|0.915
71038090|NCT00828321|141583700|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.22||||||90.0|96.34|108.58|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.58|96.34|
71038091|NCT00828321|141583701|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.52||||||90.0|92.63|104.79|||||This analysis was for informational purposes and was not used to establish bioequivalence.|||104.79|92.63|
71038092|NCT00828321|141583702|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.45||||||90.0|94.66|100.32|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||100.32|94.66|
71038093|NCT03234907|141583703|SUPERIORITY||Risk Difference (RD)|-5.2|||=|0.347|TWO_SIDED|95.0|-17.2|6.8||P-value was based on CHW test, based on weighted CMH chi-square test, with stratification according to: (1)previous failure of TNF-α antagonist therapy/concomitant use of immunomodulators(Yes/No);(2)concomitant use of oral corticosteroids(Yes/No).|Cui-Hung-Wang (CHW) test||Mantel-Haenszel estimate of the treatment difference and its variance was used to calculate the 95% confidence interval for the treatment difference. Adjustment to the stratification factors was implemented.|||6.8|-17.2|=0.347
71038094|NCT03234907|141583704|SUPERIORITY||Risk Difference (RD)|-2.7|||=|0.531|TWO_SIDED|95.0|-11.5|6.0||P-value based on Cochran-Mantel-Haenszel, weighted CMH chi-square test, with stratification according to:(1)previous failure of TNF-α antagonist therapy/concomitant use of immunomodulators(Yes/No);(2)concomitant use of oral corticosteroids(Yes/No).|Cochran-Mantel-Haenszel||Mantel-Haenszel estimate of the treatment difference and its variance was used to calculate the 95% confidence interval for the treatment difference. Adjustment to the stratification factors was implemented.|||6.0|-11.5|=0.531
71038095|NCT02664415|141583706|SUPERIORITY|||||||1|||||||Fisher Exact|This is to confirm that the p-value from Fisher's Exact test was 1.000.||||||1.000
71038096|NCT02664415|141583707|SUPERIORITY|||||||0.051|||||||Log Rank|||A comparison of time from ATI to HIV-1 RNA \>= 20 copies/mL between arms.||||0.051
71038097|NCT02664415|141583707|SUPERIORITY|||||||0.01|||||||Log Rank|||A comparison of time from ATI to HIV-1 RNA \>= 1000 copies/mL between arms.||||0.01
71038098|NCT02664415|141583708|SUPERIORITY|||||||0.027||||||This is a p-value, comparing HIV-1 RNA levels at first detection between arms.|Wilcoxon (Mann-Whitney)|||||||0.027
71038099|NCT02664415|141583708|SUPERIORITY|||||||0.588||||||This is p-value, comparing HIV-1 RNA levels at ART resumption between arms.|Wilcoxon (Mann-Whitney)|||||||0.588
71038100|NCT02664415|141583709|SUPERIORITY|||||||0.031|||||||Log Rank|||||||0.031
71098299|NCT00286455|141704693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.745|TWO_SIDED|95.0|-4.8|6.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.7|-4.8|0.745
71098300|NCT00286455|141704694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.466|TWO_SIDED|95.0|-3.4|7.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.5|-3.4|0.466
71038101|NCT02664415|141583711|SUPERIORITY|||||||0.693|||||||Wilcoxon (Mann-Whitney)|||||||0.693
71038102|NCT02664415|141583712|SUPERIORITY|||||||0.15||||||The p-value is not adjusted for multiple comparisons.|Wilcoxon signed-rank test|||A comparison of total HIV DNA at baseline ATI and ART resumption within the VRC01 arm.||||0.15
71038103|NCT02664415|141583712|SUPERIORITY|||||||0.04||||||The p-value is not adjusted for multiple comparisons.|Wilcoxon signed-rank test|||A comparison of total HIV DNA at baseline ATI and ART resumption within the placebo arm.||||0.04
71038104|NCT02664415|141583712|SUPERIORITY|||||||0.002||||||The p-value is adjusted for multiple comparisons.|Wilcoxon signed-rank test|||A comparison of total HIV DNA at ART resumption and 6 months after ART resumption within the VRC01 arm.||||0.002
71038105|NCT02664415|141583712|SUPERIORITY|||||||0.22||||||The p-value is adjusted for multiple comparisons.|Wilcoxon signed-rank test|||A comparison of total HIV DNA at ART resumption and 6 months after ART resumption within the placebo arm.||||0.22
71038106|NCT02664415|141583712|SUPERIORITY|||||||0.05|||||||Wilcoxon signed-rank test|||A comparison of total HIV DNA atbaseline ATI and 6 months after ART resumption within the VRC01 arm.||||0.05
71038107|NCT02664415|141583712|SUPERIORITY|||||||0.22|||||||Wilcoxon signed-rank test|||A comparison of total HIV DNA at baeline ATI versus 6 months after ART resumption in the placebo arm||||0.22
71038108|NCT02664415|141583715|SUPERIORITY|||||||0.961|||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at baseline ATI||||0.961
71038109|NCT02664415|141583715|SUPERIORITY|||||||0.805|||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at ART resumption||||0.805
71038110|NCT02664415|141583715|SUPERIORITY|||||||0.221|||||||Wilcoxon signed-rank test|||Comparison between Baseline and ART resumption within VRC01 arm.||||0.221
71038111|NCT02664415|141583715|SUPERIORITY|||||||0.5|||||||Wilcoxon signed-rank test|||Comparison between Baseline and ART resumption within Placebo arm.||||0.500
71038112|NCT02664415|141583716|SUPERIORITY|||||||0.522|||||||Wilcoxon (Mann-Whitney)|||Comparison between groups at baseline ATI.||||0.522
71038113|NCT02664415|141583716|SUPERIORITY|||||||0.961|||||||Wilcoxon (Mann-Whitney)|||A comparison between groups at ART resumption.||||0.961
71038114|NCT02664415|141583716|SUPERIORITY|||||||0.002|||||||Wilcoxon signed-rank test|||A comparison between baseline ATI and ART resumption within VRC01 group.||||0.002
71038115|NCT02664415|141583716|SUPERIORITY|||||||0.043|||||||Wilcoxon signed-rank test|||A comparison between baseline ATI and ART resumption within Placebo group.||||0.043
71098301|NCT00286455|141704694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0||||0.154|TWO_SIDED|95.0|-1.5|9.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||9.6|-1.5|0.154
71098302|NCT00286455|141704695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.774|TWO_SIDED|95.0|-5.1|6.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.9|-5.1|0.774
71098303|NCT00286455|141704695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.761|TWO_SIDED|95.0|-5.2|7.1||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.1|-5.2|0.761
71098304|NCT00286455|141704696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.559|TWO_SIDED|95.0|-4.2|7.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.7|-4.2|0.559
71098305|NCT00286455|141704696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.523|TWO_SIDED|95.0|-4.1|8.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||8.0|-4.1|0.523
71098306|NCT00286455|141704697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.739|TWO_SIDED|95.0|-7.4|5.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.2|-7.4|0.739
70987170|NCT03151148|141484136|SUPERIORITY||Geometric mean ratio (GMR)|1.02||||0.978|TWO_SIDED|95.0|0.174|6.027|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||6.027|0.174|0.978
71098307|NCT00286455|141704697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.388|TWO_SIDED|95.0|-9.3|3.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.6|-9.3|0.388
71098308|NCT04826731|141704698|OTHER|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||Nonparametric testing was utilized due to non-standard distribution and reduced sample size. Comparison between groups was made by Mann-Whitney U testing. Spearman's rho was utilized for correlation analysis. No subgroup analyses were planned for the study.||||0.374
71098309|NCT04826731|141704699|OTHER|||||||0.635|||||||Wilcoxon (Mann-Whitney)|||Nonparametric testing was utilized due to non-standard distribution and reduced sample size. Comparison between groups was made by Mann-Whitney U testing. Spearman's rho was utilized for correlation analysis. No subgroup analyses were planned for the study.||||0.635
71098310|NCT04359680|141704710|SUPERIORITY||Odds Ratio (OR)|1.029||||0.9434|TWO_SIDED|95.0|0.4696|2.2546|||Cochran-Mantel-Haenszel|||||2.2546|0.4696|0.9434
71098311|NCT04359680|141704711|SUPERIORITY||Odds Ratio (OR)|1.1162||||0.6805|TWO_SIDED|95.0|0.6623|1.8813|||Cochran-Mantel-Haenszel|||||1.8813|0.6623|0.6805
71098312|NCT04359680|141704713|SUPERIORITY|||||||0.3459|||||||Cochran-Mantel-Haenszel|||||||0.3459
71098313|NCT03931785|141704722|SUPERIORITY||Least squares (LS) mean difference|0.08||||0.7467|TWO_SIDED|95.0|-0.42|0.58|||MMRM||MD-7246 minus placebo|||0.58|-0.42|0.7467
71098314|NCT03931785|141704722|SUPERIORITY||LS mean difference|0.43||||0.0941|TWO_SIDED|95.0|-0.07|0.93|||MMRM||MD-7246 minus placebo|||0.93|-0.07|0.0941
71098315|NCT03931785|141704722|SUPERIORITY||LS mean difference|0.06||||0.8098|TWO_SIDED|95.0|-0.44|0.56|||MMRM||MD-7246 minus placebo|||0.56|-0.44|0.8098
70987171|NCT03151148|141484136|SUPERIORITY||Geometric mean ratio (GMR)|3.44||||0.177|TWO_SIDED|95.0|0.57|20.749|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||20.749|0.570|0.177
71098316|NCT03931785|141704723|SUPERIORITY||Difference in Responder Rate|1.0|||||TWO_SIDED|95.0|-12.9|15.0|||||Difference in responder rate (MD-7246 - placebo). 95% confidence intervals (CIs) for differences in responder rates were obtained using the normal approximation to the binomial distribution.|||15.0|-12.9|
71098317|NCT03931785|141704723|SUPERIORITY||Difference in Responder Rate|-11.3|||||TWO_SIDED|95.0|-25.3|2.6|||||Difference in responder rate (MD-7246 - placebo). 95% CIs for differences in responder rates were obtained using the normal approximation to the binomial distribution.|||2.6|-25.3|
71098318|NCT03931785|141704723|SUPERIORITY||Difference in Responder Rate|-7.2|||||TWO_SIDED|95.0|-21.2|6.8|||||Difference in responder rate (MD-7246 - placebo). 95% CIs for differences in responder rates were obtained using the normal approximation to the binomial distribution.|||6.8|-21.2|
71098319|NCT03931785|141704723|SUPERIORITY||Odds Ratio (OR)|1.043||||0.8852|TWO_SIDED|95.0|0.591|1.839|||Cochran-Mantel-Haenszel||Odds ratio for response (MD-7246 : placebo)|||1.839|0.591|0.8852
71098320|NCT03931785|141704723|SUPERIORITY||Odds Ratio (OR)|0.634||||0.1152|TWO_SIDED|95.0|0.36|1.117|||Cochran-Mantel-Haenszel||Odds ratio for response (MD-7246 : placebo)|||1.117|0.360|0.1152
71098321|NCT03931785|141704723|SUPERIORITY||Odds Ratio (OR)|0.749||||0.3157|TWO_SIDED|95.0|0.425|1.317|||Cochran-Mantel-Haenszel||Odds ratio for response (MD-7246 : placebo)|||1.317|0.425|0.3157
71098322|NCT02504775|141704726|NON_INFERIORITY_OR_EQUIVALENCE|Log-transformed PK parameter was compared between products using a linear mixed effects model including terms for product, period, sequence as fixed effect and subject nested within sequence as random effect. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25|Ratio of Averages of Tylenol/Mejoral|94.704|||||TWO_SIDED|90.0|88.329|101.54|||ANOVA|||||101.540|88.329|
71098323|NCT02504775|141704727|NON_INFERIORITY_OR_EQUIVALENCE|Log-transformed PK parameter was compared between products using a linear mixed effects model including terms for product, period, sequence as fixed effect and subject nested within sequence as random effect. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25|Ratio of Averages of Tylenol/Mejoral|95.989|||||TWO_SIDED|90.0|89.826|102.574|||ANOVA|||||102.574|89.826|
71098324|NCT02504775|141704728|NON_INFERIORITY_OR_EQUIVALENCE|Log-transformed PK parameter was compared between products using a linear mixed effects model including terms for product, period, sequence as fixed effect and subject nested within sequence as random effect. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25|Ratio of Averages of Tylenol/Mejoral|106.132|||||TWO_SIDED|90.0|85.151|132.283|||ANOVA|||||132.283|85.151|
71098325|NCT01230814|141704731|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92||||0.69|TWO_SIDED|95.0|0.62|1.37||The a priori threshold for statistical significance for VVC was p\<0.020 (two-sided).|Clustered chi-squared statistic||For the relative risk estimate, the metronidazole plus miconazole arm represented the numerator and the placebo arm represented the denominator such that a relative risk \<1 indicates a lower percentage of positive test visits in the treated arm.|Each participant within a study arm was considered a cluster, with observations at a maximum of 6 visits. The percentage of visits at which VVC was detected was compared between metronidazole plus miconazole arm versus placebo arm using a chi-squared statistic adjusted for clustering using the method of Donner and Klar (2000).||1.37|0.62|0.690
71098326|NCT01230814|141704732|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.65||||0.005|TWO_SIDED|95.0|0.48|0.87||The a priori threshold for statistical significance for BV was p\<0.030 (two-sided).|clutstered chi-squared statistic||For the relative risk estimate, the metronidazole plus miconazole arm represented the numerator and the placebo arm represented the denominator such that a relative risk \<1 indicates a lower percentage of test visits in the treated arm.|Each participant within a study arm was considered a cluster, with observations at a maximum of 6 visits. The percentage of visits at which BV was detected was compared between metronidazole plus miconazole arm versus placebo arm using a chi-squared statistic adjusted for clustering using the method of Donner and Klar (2000).||0.87|0.48|0.005
71098327|NCT02596893|141704739|SUPERIORITY||Stratified Difference|-2.9||||0.2523|TWO_SIDED|95.0|-9.7|3.9|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||3.9|-9.7|0.2523
70987172|NCT03151148|141484136|SUPERIORITY||Geometric mean ratio (GMR)|1.7||||0.558|TWO_SIDED|95.0|0.288|9.973|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||9.973|0.288|0.558
70987173|NCT03151148|141484136|SUPERIORITY||Geometric mean ratio (GMR)|1.04||||0.977|TWO_SIDED|95.0|0.082|13.151|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||13.151|0.082|0.977
70987174|NCT03151148|141484136|SUPERIORITY||Geometric mean ratio (GMR)|33.86||||0.007|TWO_SIDED|95.0|2.672|429.219|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||429.219|2.672|0.007
70987175|NCT03151148|141484136|SUPERIORITY||Geometric mean ratio (GMR)|11.97||||0.055|TWO_SIDED|95.0|0.945|151.752|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||151.752|0.945|0.055
71038116|NCT00642993|141583717|SUPERIORITY_OR_OTHER||Difference in means|0.41||||0.187|TWO_SIDED|95.0|-0.2|1.03|||ANOVA|Mean and standard error are least squares means and corresponding standard errors based on an ANOVA model with main effects for treatment.||||1.03|-0.20|0.187
71038117|NCT00642993|141583718|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58||||0.14|TWO_SIDED|95.0|0.28|1.2|||Cochran-Mantel-Haenszel|The P-value is from the Cochran-Mantel-Haenszel Test adjusting for gender.||||1.20|0.28|0.140
71038118|NCT00642993|141583719|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.515|TWO_SIDED|95.0|0.24|9.93|||Cochran-Mantel-Haenszel|The p-value is from the Cochran-Mantel-Haenszel Test adjusting for gender.||||9.93|0.24|0.515
71038119|NCT00642993|141583720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.543|TWO_SIDED|95.0|-1.2|0.63|||ANOVA|Mean and standard error are least squares means and corresponding standard errors based on an ANOVA model with main effects for treatment.||||0.63|-1.20|0.543
71038120|NCT00642993|141583721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.231|TWO_SIDED|95.0|-0.09|0.35|||ANOVA|Mean and standard error are least squares means and corresponding standard errors based on an ANOVA model with main effects for treatment.||||0.35|-0.09|0.231
71038121|NCT02986139|141583723|SUPERIORITY||LS Mean Difference|-4.0||||0.048|TWO_SIDED|95.0|-8.0|0.0|||Mixed effects analysis of variance model|||A mixed effects analysis of variance model was used to assess injection site pain with the new formulation of etanercept as the test treatment and the commercial formulation of etanercept as the reference treatment. Treatment, study period, sequence, and disease indication were evaluated as fixed effect covariates, and subject within sequence was included as a random effect.||-0.0|-8.0|0.048
71038122|NCT02155257|141583726|OTHER||Slope|0.19||||0.54|TWO_SIDED|95.0|-0.39|0.76|||Regression, Linear|||Interaction between resting pupil diameter and correlation of cognitive-affective style to pain reporting. Note that this analysis is an INTERACTION between the primary outcome of this measure (pupil diameter) to that of the primary outcome measure of cognitive-affective style.||.76|-.39|0.540
71098328|NCT02596893|141704739|SUPERIORITY||Slope|4.8||||0.1626|TWO_SIDED|95.0|-3.0|11.8|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||11.8|-3.0|0.1626
71038123|NCT00414726|141583729|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||Wilcoxon (Mann-Whitney)|We used the Van-Elteren extension of the Wilcoxon rank sum test; ajustments made for baseline NIHSS categories (4-11)(12-20)(\>20).||Subjects were analyzed using an intention to treat approach. All subjects were analyzed at 24 hours. For four subjects missing 24-hour NIHSS scores, the change score was given the highest possible value.||||0.91
71038124|NCT00414726|141583730|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||Wilcoxon (Mann-Whitney)|We used the Van Elteren extension of the Wilcoxin rank sum test that adjusts for stratified randomization.||||||0.68
71098329|NCT02596893|141704739|SUPERIORITY||Stratified Difference|-2.1||||0.442|TWO_SIDED|95.0|-9.1|5.3|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||5.3|-9.1|0.4420
71098330|NCT02596893|141704740|SUPERIORITY||Stratified Difference|-2.6||||0.1799|TWO_SIDED|95.0|-9.5|5.0|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||5.0|-9.5|0.1799
71098331|NCT02596893|141704740|SUPERIORITY||Stratified Difference|-2.4||||0.2309|TWO_SIDED|95.0|-9.4|4.9|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||4.9|-9.4|0.2309
70987176|NCT03151148|141484136|SUPERIORITY||Geometric mean ratio (GMR)|0.93||||0.957|TWO_SIDED|95.0|0.062|13.875|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||13.875|0.062|0.957
71038125|NCT01243151|141583753|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-54.68|STANDARD_ERROR_OF_MEAN|8.323|<|0.0001|TWO_SIDED|95.0|-71.37|-37.99|||ANCOVA|||Day 8: Analysis was performed using the analysis of covariance (ANCOVA) treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-37.99|-71.37|<0.0001
71038126|NCT01243151|141583753|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.18|STANDARD_ERROR_OF_MEAN|8.53|<|0.0001|TWO_SIDED|95.0|-61.28|-27.08|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-27.08|-61.28|<0.0001
71038127|NCT01243151|141583753|SUPERIORITY_OR_OTHER||LS Mean Difference|-64.44|STANDARD_ERROR_OF_MEAN|8.433|<|0.0001|TWO_SIDED|95.0|-81.35|-47.53|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-47.53|-81.35|<0.0001
71038128|NCT01243151|141583753|SUPERIORITY_OR_OTHER||LS Mean Difference|-61.75|STANDARD_ERROR_OF_MEAN|8.282|<|0.0001|TWO_SIDED|95.0|-78.36|-45.15|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-45.15|-78.36|<0.0001
71038129|NCT01243151|141583753|SUPERIORITY_OR_OTHER||LS Mean Difference|-72.16|STANDARD_ERROR_OF_MEAN|10.097|<|0.0001|TWO_SIDED|95.0|-92.4|-51.92|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-51.92|-92.40|<0.0001
71038130|NCT01243151|141583753|SUPERIORITY_OR_OTHER||LS Mean Difference|-63.89|STANDARD_ERROR_OF_MEAN|10.328|<|0.0001|TWO_SIDED|95.0|-84.59|-43.19|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-43.19|-84.59|<0.0001
71038131|NCT01243151|141583753|SUPERIORITY_OR_OTHER||LS Mean Difference|-88.69|STANDARD_ERROR_OF_MEAN|10.327|<|0.0001|TWO_SIDED|95.0|-109.39|-68.0|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-68.00|-109.39|<0.0001
70987177|NCT03151148|141484136|SUPERIORITY||Geometric mean ratio (GMR)|1.78||||0.654|TWO_SIDED|95.0|0.141|22.607|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||22.607|0.141|0.654
71038132|NCT01243151|141583753|SUPERIORITY_OR_OTHER||LS Mean Difference|-84.65|STANDARD_ERROR_OF_MEAN|10.028|<|0.0001|TWO_SIDED|95.0|-104.76|-64.54|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-64.54|-104.76|<0.0001
71038133|NCT01243151|141583753|SUPERIORITY_OR_OTHER||LS Mean Difference|-78.47|STANDARD_ERROR_OF_MEAN|8.854|<|0.0001|TWO_SIDED|95.0|-96.22|-60.71|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-60.71|-96.22|<0.0001
71038134|NCT01243151|141583753|SUPERIORITY_OR_OTHER||LS Mean Difference|-84.45|STANDARD_ERROR_OF_MEAN|8.998|<|0.0001|TWO_SIDED|95.0|-102.51|-66.4|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-66.40|-102.51|<0.0001
71098332|NCT02596893|141704740|SUPERIORITY||Stratified Difference|-2.1||||0.3264|TWO_SIDED|95.0|-9.1|4.6|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||4.6|-9.1|0.3264
71038135|NCT01243151|141583753|SUPERIORITY_OR_OTHER||LS Mean Difference|-96.08|STANDARD_ERROR_OF_MEAN|8.994|<|0.0001|TWO_SIDED|95.0|-114.12|-78.03|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-78.03|-114.12|<0.0001
71038136|NCT01243151|141583753|SUPERIORITY_OR_OTHER||LS Mean Difference|-92.33|STANDARD_ERROR_OF_MEAN|8.703|<|0.0001|TWO_SIDED|95.0|-109.8|-74.86|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-74.86|-109.80|<0.0001
71098333|NCT02596893|141704741|SUPERIORITY||Stratified Difference|-11.7||||0.0299|TWO_SIDED|95.0|-22.0|-1.1|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||-1.1|-22.0|0.0299
71098334|NCT02596893|141704741|SUPERIORITY||Stratified difference|-9.9||||0.0582|TWO_SIDED|95.0|-20.3|0.7|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||0.7|-20.3|0.0582
70987178|NCT03151148|141484138|SUPERIORITY||Geometric mean ratio (GMR)|2.722||||0.432|TWO_SIDED|95.0|0.2227|33.2594|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||33.2594|0.2227|0.432
70987179|NCT03151148|141484138|SUPERIORITY||Geometric mean ratio (GMR)|0.147||||0.133|TWO_SIDED|95.0|0.0121|1.8018|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.8018|0.0121|0.133
70987180|NCT03151148|141484138|SUPERIORITY||Geometric mean ratio (GMR)|0.371||||0.437|TWO_SIDED|95.0|0.0304|4.5392|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||4.5392|0.0304|0.437
71038137|NCT01243151|141583753|SUPERIORITY_OR_OTHER||LS Mean Difference|-71.41|STANDARD_ERROR_OF_MEAN|9.534|<|0.0001|TWO_SIDED|95.0|-90.51|-52.3|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-52.30|-90.51|<0.0001
71038138|NCT01243151|141583753|SUPERIORITY_OR_OTHER||LS Mean Difference|-76.01|STANDARD_ERROR_OF_MEAN|9.659|<|0.0001|TWO_SIDED|95.0|-95.37|-56.65|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-56.65|-95.37|<0.0001
71038139|NCT01243151|141583753|SUPERIORITY_OR_OTHER||LS Mean Difference|-93.78|STANDARD_ERROR_OF_MEAN|9.678|<|0.0001|TWO_SIDED|95.0|-113.18|-74.38|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-74.38|-113.18|<0.0001
71038140|NCT01243151|141583753|SUPERIORITY_OR_OTHER||LS Mean Difference|-89.58|STANDARD_ERROR_OF_MEAN|9.362|<|0.0001|TWO_SIDED|95.0|-108.35|-70.81|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-70.81|-108.35|<0.0001
71038141|NCT01243151|141583754|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.82|STANDARD_ERROR_OF_MEAN|5.077|<|0.0001|TWO_SIDED|95.0|-43.99|-23.65|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-23.65|-43.99|<0.0001
71038142|NCT01243151|141583754|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.93|STANDARD_ERROR_OF_MEAN|5.202|<|0.0001|TWO_SIDED|95.0|-38.35|-17.51|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-17.51|-38.35|<0.0001
71038143|NCT01243151|141583754|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.59|STANDARD_ERROR_OF_MEAN|5.143|<|0.0001|TWO_SIDED|95.0|-49.89|-29.28|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.28|-49.89|<0.0001
71038144|NCT01243151|141583754|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.63|STANDARD_ERROR_OF_MEAN|5.051|<|0.0001|TWO_SIDED|95.0|-47.75|-27.51|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-27.51|-47.75|<0.0001
71038145|NCT01243151|141583754|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.99|STANDARD_ERROR_OF_MEAN|6.384|<|0.0001|TWO_SIDED|95.0|-58.78|-33.2|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-33.20|-58.78|<0.0001
71038146|NCT01243151|141583754|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.82|STANDARD_ERROR_OF_MEAN|6.527|<|0.0001|TWO_SIDED|95.0|-54.9|-28.74|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-28.74|-54.90|<0.0001
71098335|NCT02596893|141704741|SUPERIORITY||Stratified difference|-9.7||||0.0741|TWO_SIDED|95.0|-20.1|1.0|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||1.0|-20.1|0.0741
71098336|NCT02596893|141704742|SUPERIORITY||Stratified difference|-5.8||||0.2493|TWO_SIDED|95.0|-15.5|4.0|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||4.0|-15.5|0.2493
71098337|NCT02596893|141704742|SUPERIORITY||Stratified difference|-1.8||||0.716|TWO_SIDED|95.0|-11.8|8.2|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||8.2|-11.8|0.7160
70987181|NCT03151148|141484138|SUPERIORITY||Geometric mean ratio (GMR)|1.247||||0.863|TWO_SIDED|95.0|0.1002|15.5231|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||15.5231|0.1002|0.863
70987182|NCT03151148|141484138|SUPERIORITY||Geometric mean ratio (GMR)|0.615||||0.702|TWO_SIDED|95.0|0.0503|7.5106|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||7.5106|0.0503|0.702
70987183|NCT03151148|141484138|SUPERIORITY||Geometric mean ratio (GMR)|0.465||||0.675|TWO_SIDED|95.0|0.0128|16.8576|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||16.8576|0.0128|0.675
70987184|NCT03151148|141484138|SUPERIORITY||Geometric mean ratio (GMR)|32.638||||0.057|TWO_SIDED|95.0|0.8994|1184.4298|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1184.4298|0.8994|0.057
70987185|NCT03151148|141484138|SUPERIORITY||Geometric mean ratio (GMR)|11.539||||0.181|TWO_SIDED|95.0|0.318|418.7586|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||418.7586|0.3180|0.181
70987186|NCT03151148|141484138|SUPERIORITY||Geometric mean ratio (GMR)|0.895||||0.953|TWO_SIDED|95.0|0.0219|36.5559|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||36.5559|0.0219|0.953
70987187|NCT03151148|141484138|SUPERIORITY||Geometric mean ratio (GMR)|1.719||||0.767|TWO_SIDED|95.0|0.0474|62.3828|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||62.3828|0.0474|0.767
70987188|NCT03151148|141484140|SUPERIORITY||Geometric mean ratio (GMR)|1.395||||0.488|TWO_SIDED|95.0|0.5429|3.5835|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.5835|0.5429|0.488
71038147|NCT01243151|141583754|SUPERIORITY_OR_OTHER||LS Mean Difference|-56.35|STANDARD_ERROR_OF_MEAN|6.531|<|0.0001|TWO_SIDED|95.0|-69.43|-43.27|||ANCOVA|||Day 15: Analysis was performed using ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-43.27|-69.43|<0.0001
71038148|NCT01243151|141583754|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.45|STANDARD_ERROR_OF_MEAN|6.344|<|0.0001|TWO_SIDED|95.0|-66.17|-40.74|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-40.74|-66.17|<0.0001
71038149|NCT01243151|141583754|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.67|STANDARD_ERROR_OF_MEAN|5.498|<|0.0001|TWO_SIDED|95.0|-60.7|-38.64|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-38.64|-60.70|<0.0001
71038150|NCT01243151|141583754|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.92|STANDARD_ERROR_OF_MEAN|5.592|<|0.0001|TWO_SIDED|95.0|-65.14|-42.7|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-42.70|-65.14|<0.0001
71038151|NCT01243151|141583754|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.6|STANDARD_ERROR_OF_MEAN|5.59|<|0.0001|TWO_SIDED|95.0|-71.81|-49.38|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-49.38|-71.81|<0.0001
71038152|NCT01243151|141583754|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.67|STANDARD_ERROR_OF_MEAN|5.413|<|0.0001|TWO_SIDED|95.0|-68.53|-46.8|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-46.80|-68.53|<0.0001
71038153|NCT01243151|141583754|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.18|STANDARD_ERROR_OF_MEAN|5.8|<|0.0001|TWO_SIDED|95.0|-55.8|-32.57|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-32.57|-55.80|<0.0001
71098338|NCT02596893|141704742|SUPERIORITY||Stratified difference|-5.8||||0.2452|TWO_SIDED|95.0|-15.5|4.1|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||4.1|-15.5|0.2452
71098339|NCT02596893|141704743|SUPERIORITY||Stratified difference|-1.3||||0.7541|TWO_SIDED|95.0|-9.8|7.1|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||7.1|-9.8|0.7541
71098340|NCT02596893|141704743|SUPERIORITY||Stratified difference|-3.7||||0.3784|TWO_SIDED|95.0|-12.0|4.6|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||4.6|-12.0|0.3784
71038154|NCT01243151|141583754|SUPERIORITY_OR_OTHER||LS Mean Difference|-47.28|STANDARD_ERROR_OF_MEAN|5.881|<|0.0001|TWO_SIDED|95.0|-59.06|-35.5|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-35.50|-59.06|<0.0001
71038155|NCT01243151|141583754|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.73|STANDARD_ERROR_OF_MEAN|5.891|<|0.0001|TWO_SIDED|95.0|-69.53|-45.94|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-45.94|-69.53|<0.0001
71098341|NCT02596893|141704743|SUPERIORITY||Stratified difference|-4.4||||0.2865|TWO_SIDED|95.0|-12.6|3.8|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||3.8|-12.6|0.2865
71098342|NCT02596893|141704744|SUPERIORITY||Unstratified CMH|-2.2||||0.3572|TWO_SIDED|95.0|-11.3|7.0|||Cochran-Mantel-Haenszel|p-values were based on the unstratified CMH test when 1 and only 1 of the 2 treatment groups being compared had no subjects in a stratum.|The weighted average of the treatment differences across the strata with the CMH weights.|2-sided 95% CI were based on the unstratified Newcombe method.||7.0|-11.3|0.3572
71098343|NCT02596893|141704744|SUPERIORITY||Stratified difference|4.7||||0.2823|TWO_SIDED|95.0|-8.8|18.9|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||18.9|-8.8|0.2823
71098344|NCT02596893|141704744|SUPERIORITY||Stratified difference|0.0|||>|0.9999|TWO_SIDED|95.0|-12.8|13.7|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||13.7|-12.8|> 0.9999
70987189|NCT03151148|141484140|SUPERIORITY||Geometric mean ratio (GMR)|2.823||||0.03|TWO_SIDED|95.0|1.1038|7.221|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||7.2210|1.1038|0.030
70987190|NCT03151148|141484140|SUPERIORITY||Geometric mean ratio (GMR)|2.077||||0.127|TWO_SIDED|95.0|0.8122|5.3135|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||5.3135|0.8122|0.127
70987191|NCT03151148|141484140|SUPERIORITY||Geometric mean ratio (GMR)|0.789||||0.623|TWO_SIDED|95.0|0.3065|2.0331|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.0331|0.3065|0.623
70987192|NCT03151148|141484140|SUPERIORITY||Geometric mean ratio (GMR)|0.627||||0.328|TWO_SIDED|95.0|0.245|1.6028|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.6028|0.2450|0.328
71008826|NCT02055976|141525259|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.52435|STANDARD_ERROR_OF_MEAN|3.66973|<|0.001|TWO_SIDED|95.0|-47.81299|-33.23571|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-33.23571|-47.81299|<0.001
71038156|NCT01243151|141583754|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.96|STANDARD_ERROR_OF_MEAN|5.701|<|0.0001|TWO_SIDED|95.0|-66.38|-43.54|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-43.54|-66.38|<0.0001
71038157|NCT01243151|141583755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.972||||0.0472|TWO_SIDED|95.0|1.04|599.65|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||599.65|1.04|0.0472
71038158|NCT01243151|141583755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.815||||0.1368|TWO_SIDED|95.0|0.46|305.54|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||305.54|0.46|0.1368
71038159|NCT01243151|141583755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|47.527||||0.019|TWO_SIDED|95.0|1.89|1198.29|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||1198.29|1.89|0.0190
70987193|NCT03151148|141484140|SUPERIORITY||Geometric mean ratio (GMR)|2.231||||0.242|TWO_SIDED|95.0|0.5799|8.5866|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||8.5866|0.5799|0.242
70987194|NCT03151148|141484140|SUPERIORITY||Geometric mean ratio (GMR)|1.977||||0.321|TWO_SIDED|95.0|0.5137|7.6055|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||7.6055|0.5137|0.321
70987195|NCT03151148|141484140|SUPERIORITY||Geometric mean ratio (GMR)|1.86||||0.366|TWO_SIDED|95.0|0.4833|7.1564|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||7.1564|0.4833|0.366
70987196|NCT03151148|141484140|SUPERIORITY||Geometric mean ratio (GMR)|3.713||||0.068|TWO_SIDED|95.0|0.908|15.1856|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||15.1856|0.9080|0.068
70987197|NCT03151148|141484140|SUPERIORITY||Geometric mean ratio (GMR)|2.858||||0.13|TWO_SIDED|95.0|0.7328|11.1434|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||11.1434|0.7328|0.130
70987198|NCT03151148|141484141|SUPERIORITY||Geometric mean ratio (GMR)|3.16||||0.233|TWO_SIDED|95.0|0.476|20.952|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||20.952|0.476|0.233
71038160|NCT01243151|141583755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|45.328||||0.0192|TWO_SIDED|95.0|1.86|1103.73|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||1103.73|1.86|0.0192
71038161|NCT01243151|141583755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|74.273||||0.0105|TWO_SIDED|95.0|2.74|2014.67|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||2014.67|2.74|0.0105
71038162|NCT01243151|141583755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|86.088||||0.0086|TWO_SIDED|95.0|3.1|2389.27|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||2389.27|3.10|0.0086
71038163|NCT01243151|141583755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|87.733||||0.0084|TWO_SIDED|95.0|3.14|2449.11|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||2449.11|3.14|0.0084
71038164|NCT01243151|141583755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|112.272||||0.0053|TWO_SIDED|95.0|4.07|3097.22|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||3097.22|4.07|0.0053
71038165|NCT01243151|141583755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|27.697||||0.0403|TWO_SIDED|95.0|1.16|662.2|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||662.20|1.16|0.0403
70987199|NCT03151148|141484141|SUPERIORITY||Geometric mean ratio (GMR)|0.08||||0.008|TWO_SIDED|95.0|0.012|0.514|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.514|0.012|0.008
71008827|NCT02055976|141525259|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.14495|STANDARD_ERROR_OF_MEAN|3.71641|<|0.001|TWO_SIDED|95.0|-63.52668|-48.76322|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-48.76322|-63.52668|<0.001
71008828|NCT02055976|141525259|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.5637|STANDARD_ERROR_OF_MEAN|3.7569|<|0.001|TWO_SIDED|95.0|-69.0251|-54.1023|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-54.10230|-69.02510|<0.001
71038166|NCT01243151|141583755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|30.247||||0.0361|TWO_SIDED|95.0|1.25|733.32|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||733.32|1.25|0.0361
70987200|NCT03151148|141484141|SUPERIORITY||Geometric mean ratio (GMR)|0.04||||0.001|TWO_SIDED|95.0|0.007|0.298|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.298|0.007|0.001
70987201|NCT03151148|141484141|SUPERIORITY||Geometric mean ratio (GMR)|0.09||||0.017|TWO_SIDED|95.0|0.013|0.651|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.651|0.013|0.017
71008829|NCT02055976|141525259|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-46.34109|STANDARD_ERROR_OF_MEAN|4.16385|<|0.001|TWO_SIDED|95.0|-54.61427|-38.06792|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-38.06792|-54.61427|<0.001
71008830|NCT02055976|141525259|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.3789|STANDARD_ERROR_OF_MEAN|4.09957|<|0.001|TWO_SIDED|95.0|-69.52338|-53.23443|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-53.23443|-69.52338|<0.001
71038167|NCT01243151|141583755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|89.341||||0.0069|TWO_SIDED|95.0|3.43|2326.44|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||2326.44|3.43|0.0069
71038168|NCT01243151|141583755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|76.034||||0.0081|TWO_SIDED|95.0|3.08|1875.15|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||1875.15|3.08|0.0081
71038169|NCT01243151|141583755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.018||||0.9931|TWO_SIDED|95.0|0.02|64.41|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||64.41|0.02|0.9931
71008831|NCT02055976|141525259|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-64.67274|STANDARD_ERROR_OF_MEAN|4.06866|<|0.001|TWO_SIDED|95.0|-72.75728|-56.5882|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-56.58820|-72.75728|<0.001
71008832|NCT02514889|141525282|SUPERIORITY||Mean Difference (Final Values)|-2.11|STANDARD_ERROR_OF_MEAN|2.05||0.3|TWO_SIDED|95.0|-6.12|1.91||a priori threshold is p = .017, so that experiment-wide critical alpha would be p = .05.|Mixed Models Analysis|Covariates: sex, age, ethnicity, marital status and educational attainment|Difference in differences interaction term is the product of assessment period (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting).|||1.91|-6.12|0.30
71008833|NCT02514889|141525283|EQUIVALENCE|p-value \>0.20 would be considered equivalent.|Mean Difference (Final Values)|2.59|STANDARD_ERROR_OF_MEAN|1.39||0.06|TWO_SIDED|95.0|-0.1342|5.3228|||Mixed Models Analysis|Covariates included age, sex, ethnicity, educational attainment and marital status||||5.3228|-0.1342|0.06
71008834|NCT02514889|141525284|SUPERIORITY||Mean Difference (Net)|-1.37|STANDARD_ERROR_OF_MEAN|2.55||0.504|TWO_SIDED|95.0|-6.37|3.63|||Mixed Models Analysis|Covariates included: age, sex, ethnicity, educational attainment and marital status|Difference in differences interaction term is the product of assessment period (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting).|||3.63|-6.37|0.504
71008835|NCT02514889|141525285|SUPERIORITY|Difference in differences|Mean Difference (Net)|-1.88|STANDARD_ERROR_OF_MEAN|2.35||0.3|TWO_SIDED|95.0|-6.47|2.74|||Mixed Models Analysis|Covariates included: age, sex, ethnicity, educational attainment, marital status|The difference in differences interaction term is the product of assessment period (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting)|||2.74|-6.47|0.30
71008836|NCT02514889|141525286|SUPERIORITY||Mean Difference (Net)|0.46|STANDARD_ERROR_OF_MEAN|0.99||0.64|TWO_SIDED|95.0|-1.47|2.39|||Mixed Models Analysis||The differences in difference interaction term consists of the product of assessment intervals (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting)|||2.39|-1.47|0.640
70987202|NCT03151148|141484141|SUPERIORITY||Geometric mean ratio (GMR)|0.04||||0.001|TWO_SIDED|95.0|0.007|0.292|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.292|0.007|0.001
70987203|NCT03151148|141484141|SUPERIORITY||Geometric mean ratio (GMR)|2.42||||0.358|TWO_SIDED|95.0|0.366|15.967|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||15.967|0.366|0.358
70987204|NCT03151148|141484141|SUPERIORITY||Geometric mean ratio (GMR)|0.1||||0.019|TWO_SIDED|95.0|0.016|0.683|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.683|0.016|0.019
70987205|NCT03151148|141484141|SUPERIORITY||Geometric mean ratio (GMR)|0.11||||0.023|TWO_SIDED|95.0|0.017|0.739|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.739|0.017|0.023
70987206|NCT03151148|141484141|SUPERIORITY||Geometric mean ratio (GMR)|0.09||||0.017|TWO_SIDED|95.0|0.013|0.647|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.647|0.013|0.017
70987207|NCT03151148|141484141|SUPERIORITY||Geometric mean ratio (GMR)|0.37||||0.299|TWO_SIDED|95.0|0.056|2.436|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.436|0.056|0.299
71038170|NCT01243151|141583755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|38.943||||0.0259|TWO_SIDED|95.0|1.55|975.84|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||975.84|1.55|0.0259
71038171|NCT01243151|141583755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|57.766||||0.0142|TWO_SIDED|95.0|2.26|1477.88|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||1477.88|2.26|0.0142
71038172|NCT01243151|141583755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|48.734||||0.0179|TWO_SIDED|95.0|1.95|1216.9|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||1216.90|1.95|0.0179
71098345|NCT02596893|141704745|SUPERIORITY||Stratified difference|-0.5||||0.8031|TWO_SIDED|95.0|-6.7|5.9|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||5.9|-6.7|0.8031
71098346|NCT02596893|141704745|SUPERIORITY||Stratified difference|1.4||||0.5583|TWO_SIDED|95.0|-5.1|7.3|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||7.3|-5.1|0.5583
71098347|NCT02596893|141704745|SUPERIORITY||Stratified difference|-1.0||||0.6123|TWO_SIDED|95.0|-7.2|6.8|||Cochran-Mantel-Haenszel||||The weighted average of the treatment differences across the strata with the CMH weights.|6.8|-7.2|0.6123
70987208|NCT03151148|141484142|SUPERIORITY||Geometric mean ratio (GMR)|1.49||||0.538|TWO_SIDED|95.0|0.415|5.38|||Mixed Models Analysis|||"TMT vs Placebo on Lesional Skin at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."|All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|5.380|0.415|0.538
70987209|NCT03151148|141484142|SUPERIORITY||Geometric mean ratio (GMR)|0.88||||0.849|TWO_SIDED|95.0|0.245|3.18|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.180|0.245|0.849
70987210|NCT03151148|141484142|SUPERIORITY||Geometric mean ratio (GMR)|0.4||||0.155|TWO_SIDED|95.0|0.11|1.424|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.424|0.110|0.155
70987211|NCT03151148|141484142|SUPERIORITY||Geometric mean ratio (GMR)|0.45||||0.242|TWO_SIDED|95.0|0.117|1.722|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.722|0.117|0.242
70987212|NCT03151148|141484142|SUPERIORITY||Geometric mean ratio (GMR)|0.47||||0.258|TWO_SIDED|95.0|0.129|1.735|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.735|0.129|0.258
70987213|NCT03151148|141484142|SUPERIORITY||Geometric mean ratio (GMR)|1.26||||0.726|TWO_SIDED|95.0|0.349|4.52|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||4.520|0.349|0.726
70987214|NCT03151148|141484142|SUPERIORITY||Geometric mean ratio (GMR)|0.32||||0.08|TWO_SIDED|95.0|0.088|1.145|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.145|0.088|0.080
71008837|NCT02514889|141525287|EQUIVALENCE|For the comparison conditions to be equivalent, as predicted, the critical alpha was set at P \> 0.20.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.135||0.747|TWO_SIDED|95.0|-0.31|0.22|||Mixed Models Analysis|Covariates included: age, sex, ethnicity, educational attainment and marital status|The differences in difference interaction term consists of the product of assessment intervals (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting)|||0.22|-.31|0.747
71098348|NCT02596893|141704746|SUPERIORITY||Stratified difference|-10.6||||0.0239|TWO_SIDED|95.0|-19.6|-1.4|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||-1.4|-19.6|0.0239
71098349|NCT02596893|141704746|SUPERIORITY||Stratified difference|-1.0||||0.8334|TWO_SIDED|95.0|-10.8|8.7|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||8.7|-10.8|0.8334
71098350|NCT02596893|141704746|SUPERIORITY||Stratified difference|-3.9||||0.4383|TWO_SIDED|95.0|-13.5|5.8|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||5.8|-13.5|0.4383
71098351|NCT02596893|141704747|SUPERIORITY||Stratified difference|-1.6||||0.3573|TWO_SIDED|95.0|-8.3|5.9|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with CMH weights.|||5.9|-8.3|0.3573
71098352|NCT02596893|141704747|SUPERIORITY||Stratified difference|-2.0||||0.2221|TWO_SIDED|95.0|-8.7|5.1|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||5.1|-8.7|0.2221
71098353|NCT02596893|141704747|SUPERIORITY||Stratified difference|-2.0||||0.2578|TWO_SIDED|95.0|-8.7|5.6|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||5.6|-8.7|0.2578
71038173|NCT01243151|141583756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|353.058||||0.0013|TWO_SIDED|95.0|9.95|12528.19|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||12528.19|9.95|0.0013
71038174|NCT01243151|141583756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|129.984||||0.0047|TWO_SIDED|95.0|4.44|3808.21|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||3808.21|4.44|0.0047
71038175|NCT01243151|141583756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|300.099||||0.0018|TWO_SIDED|95.0|8.35|10787.45|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||10787.45|8.35|0.0018
71038176|NCT01243151|141583756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|190.835||||0.0025|TWO_SIDED|95.0|6.34|5743.12|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||5743.12|6.34|0.0025
71038177|NCT01243151|141583756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|255.421||||0.0018|TWO_SIDED|95.0|7.87|8290.22|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||8290.22|7.87|0.0018
71038178|NCT01243151|141583756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|150.547||||0.0034|TWO_SIDED|95.0|5.28|4291.89|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||4291.89|5.28|0.0034
71038179|NCT01243151|141583756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|745.542||||0.0018|TWO_SIDED|95.0|11.6|47929.45|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||47929.45|11.60|0.0018
71038180|NCT01243151|141583756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|146.296||||0.0031|TWO_SIDED|95.0|5.4|3963.01|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||3963.01|5.40|0.0031
71038181|NCT01243151|141583756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|213.512||||0.002|TWO_SIDED|95.0|7.13|6396.64|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||6396.64|7.13|0.0020
71038182|NCT01243151|141583756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|124.439||||0.0038|TWO_SIDED|95.0|4.73|3277.13|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||3277.13|4.73|0.0038
71038183|NCT01243151|141583756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|622.309||||0.002|TWO_SIDED|95.0|10.51|36846.03|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||36846.03|10.51|0.0020
71038184|NCT01243151|141583756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|224.427||||0.0017|TWO_SIDED|95.0|7.63|6598.0|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||6598.00|7.63|0.0017
71038185|NCT01243151|141583756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.158||||0.2751|TWO_SIDED|95.0|0.24|161.08|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||161.08|0.24|0.2751
71038186|NCT01243151|141583756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|152.977||||0.0038|TWO_SIDED|95.0|5.05|4633.92|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||4633.92|5.05|0.0038
71038187|NCT01243151|141583756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|756.203||||0.002|TWO_SIDED|95.0|11.18|51133.53|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||51133.53|11.18|0.0020
71038188|NCT01243151|141583756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|258.938||||0.0021|TWO_SIDED|95.0|7.53|8902.61|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||8902.61|7.53|0.0021
71038189|NCT01243151|141583757|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.896||||0.958|TWO_SIDED|95.0|0.02|52.79|||Regression, Logistic|||Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||52.79|0.02|0.9580
71038190|NCT01243151|141583757|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.375||||0.0732|TWO_SIDED|95.0|0.76|394.65|||Regression, Logistic|||Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||394.65|0.76|0.0732
71038191|NCT01243151|141583757|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|47.86||||0.0159|TWO_SIDED|95.0|2.07|1109.11|||Regression, Logistic|||Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||1109.11|2.07|0.0159
70987215|NCT03151148|141484142|SUPERIORITY||Geometric mean ratio (GMR)|0.81||||0.748|TWO_SIDED|95.0|0.225|2.917|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.917|0.225|0.748
70987216|NCT03151148|141484142|SUPERIORITY||Geometric mean ratio (GMR)|1.23||||0.76|TWO_SIDED|95.0|0.327|4.617|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||4.617|0.327|0.760
70987217|NCT03151148|141484142|SUPERIORITY||Geometric mean ratio (GMR)|0.79||||0.713|TWO_SIDED|95.0|0.219|2.832|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.832|0.219|0.713
70987218|NCT03151148|141484143|SUPERIORITY||Geometric mean ratio (GMR)|12.08|||<|0.001|TWO_SIDED|95.0|3.524|41.435|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||41.435|3.524|<0.001
70987219|NCT03151148|141484143|SUPERIORITY||Geometric mean ratio (GMR)|2.58||||0.131|TWO_SIDED|95.0|0.753|8.853|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||8.853|0.753|0.131
70987220|NCT03151148|141484143|SUPERIORITY||Geometric mean ratio (GMR)|2.2||||0.21|TWO_SIDED|95.0|0.64|7.527|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||7.527|0.640|0.210
70987221|NCT03151148|141484143|SUPERIORITY||Geometric mean ratio (GMR)|3.98||||0.031|TWO_SIDED|95.0|1.138|13.29|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||13.290|1.138|0.031
70987222|NCT03151148|141484143|SUPERIORITY||Geometric mean ratio (GMR)|1.64||||0.429|TWO_SIDED|95.0|0.479|5.63|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||5.630|0.479|0.429
71038192|NCT01243151|141583757|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|33.246||||0.0264|TWO_SIDED|95.0|1.51|733.62|||Regression, Logistic|||Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||733.62|1.51|0.0264
71038193|NCT01243151|141583758|SUPERIORITY_OR_OTHER||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|5.131||0.2883|TWO_SIDED|95.0|-4.77|15.77|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||15.77|-4.77|0.2883
71038194|NCT01243151|141583758|SUPERIORITY_OR_OTHER||LS Mean Difference|6.05|STANDARD_ERROR_OF_MEAN|5.277||0.2563|TWO_SIDED|95.0|-4.51|16.61|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||16.61|-4.51|0.2563
70987223|NCT03151148|141484143|SUPERIORITY||Geometric mean ratio (GMR)|9.26||||0.01|TWO_SIDED|95.0|1.712|50.043|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||50.043|1.712|0.010
70987224|NCT03151148|141484143|SUPERIORITY||Geometric mean ratio (GMR)|3.45||||0.15|TWO_SIDED|95.0|0.637|18.627|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||18.627|0.637|0.150
71038195|NCT01243151|141583758|SUPERIORITY_OR_OTHER||LS Mean Difference|1.92|STANDARD_ERROR_OF_MEAN|5.225||0.7149|TWO_SIDED|95.0|-8.54|12.37|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||12.37|-8.54|0.7149
71038196|NCT01243151|141583758|SUPERIORITY_OR_OTHER||LS Mean Difference|3.95|STANDARD_ERROR_OF_MEAN|5.174||0.448|TWO_SIDED|95.0|-6.4|14.3|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||14.30|-6.40|0.4480
71038197|NCT01243151|141583758|SUPERIORITY_OR_OTHER||LS Mean Difference|14.5|STANDARD_ERROR_OF_MEAN|6.214||0.0231|TWO_SIDED|95.0|2.06|26.94|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||26.94|2.06|0.0231
71098354|NCT02596893|141704750|SUPERIORITY||Stratified Difference|0.5||||0.9141|TWO_SIDED|95.0|-8.9|10.0|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights|||10.0|-8.9|0.9141
71098355|NCT02596893|141704750|SUPERIORITY||Stratified Difference|-3.6||||0.4286|TWO_SIDED|95.0|-12.8|5.6|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||5.6|-12.8|0.4286
70987225|NCT03151148|141484143|SUPERIORITY||Geometric mean ratio (GMR)|5.47||||0.048|TWO_SIDED|95.0|1.012|29.578|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||29.578|1.012|0.048
70987226|NCT03151148|141484143|SUPERIORITY||Geometric mean ratio (GMR)|3.98||||0.13|TWO_SIDED|95.0|0.665|23.821|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||23.821|0.665|0.130
70987227|NCT03151148|141484143|SUPERIORITY||Geometric mean ratio (GMR)|13.74||||0.002|TWO_SIDED|95.0|2.542|74.304|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||74.304|2.542|0.002
71098356|NCT02596893|141704750|SUPERIORITY||Stratified Difference|-2.7||||0.5591|TWO_SIDED|95.0|-12.0|6.6|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||6.6|-12.0|0.5591
71098357|NCT03052257|141704751|SUPERIORITY||Median Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|0.15|0.3|||Regression, Linear|||||0.30|0.15|<0.0001
71098358|NCT02255279|141704776|NON_INFERIORITY_OR_EQUIVALENCE|"Hypothesis: Demonstrate non-inferiority (NI) of aTIV to TIV:~H0 : μAi - μBi ≤ -0.176 (Null) H1 : μAi - μBi \>-0.176 (alternative) (i= H1N1, H3N2, B) μA and μB are means of log10-transformed titers 21 days after last vaccination of the aTIV \& TIV vaccine groups respectively. NI is claimed if LL of 95% CI for GMT ratios is \>0.67.~Significance level is α = 2.5% (1-sided), which needs no further adjustment for multiplicity as to reach NI, above hypothesis needs to be rejected for all 3 strains."|Ratio of GMTs|4.06|||||TWO_SIDED|95.0|3.0|5.51|||ANCOVA|||Geometric mean titers (GMTs), in H1N1 strain of all the tree strains in Subjects 6 to \< 72 months of Age.||5.51|3.00|
70987228|NCT03151148|141484144|SUPERIORITY||Geometric mean ratio (GMR)|3.68||||0.001|TWO_SIDED|95.0|1.689|8.028|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||8.028|1.689|0.001
70987229|NCT03151148|141484144|SUPERIORITY||Geometric mean ratio (GMR)|2.42||||0.027|TWO_SIDED|95.0|1.109|5.267|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||5.267|1.109|0.027
70987230|NCT03151148|141484144|SUPERIORITY||Geometric mean ratio (GMR)|1.76||||0.153|TWO_SIDED|95.0|0.81|3.847|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.847|0.810|0.153
70987231|NCT03151148|141484144|SUPERIORITY||Geometric mean ratio (GMR)|1.76||||0.16|TWO_SIDED|95.0|0.799|3.884|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.884|0.799|0.160
70987232|NCT03151148|141484144|SUPERIORITY||Geometric mean ratio (GMR)|1.32||||0.489|TWO_SIDED|95.0|0.603|2.868|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.868|0.603|0.489
70987233|NCT03151148|141484144|SUPERIORITY||Geometric mean ratio (GMR)|3.1||||0.044|TWO_SIDED|95.0|1.032|9.295|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||9.295|1.032|0.044
70987234|NCT03151148|141484144|SUPERIORITY||Geometric mean ratio (GMR)|0.87||||0.805|TWO_SIDED|95.0|0.29|2.614|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.614|0.290|0.805
71008838|NCT02514889|141525288|EQUIVALENCE|For the comparison conditions to be judged equivalent, as predicted, the critical p-value was set to P \>.20|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.51||0.776|TWO_SIDED|95.0|-0.85|1.14|||Mixed Models Analysis|Covariates included: age, sex, ethnicity, educational attainment and marital status|The differences in difference interaction term consists of the product of assessment intervals (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting)|||1.14|-0.85|0.776
71098359|NCT02255279|141704776|NON_INFERIORITY_OR_EQUIVALENCE|"Hypothesis: Demonstrate non-inferiority (NI) of aTIV to TIV:~H0 : μAi - μBi ≤ -0.176 (Null) H1 : μAi - μBi \>-0.176 (alternative) (i= H1N1, H3N2, B) μA and μB are means of log10-transformed titers 21 days after last vaccination of the aTIV \& TIV vaccine groups respectively. NI is claimed if LL of 95% CI for GMT ratios is \>0.67.~Significance level is α = 2.5% (1-sided), which needs no further adjustment for multiplicity as to reach NI, above hypothesis needs to be rejected for all 3 strains."|Ratio of GMTs|2.58|||||TWO_SIDED|95.0|2.05|3.25|||ANCOVA|||Geometric mean titers (GMTs), in H3N2 strain of all three homologous virus strains in Subjects 6 to \< 72 months of Age.||3.25|2.05|
71098360|NCT02255279|141704776|NON_INFERIORITY_OR_EQUIVALENCE|"Hypothesis: Demonstrate non-inferiority (NI) of aTIV to TIV:~H0 : μAi - μBi ≤ -0.176 (Null) H1 : μAi - μBi \>-0.176 (alternative) (i= H1N1, H3N2, B) μA and μB are means of log10-transformed titers 21 days after last vaccination of the aTIV \& TIV vaccine groups respectively. NI is claimed if LL of 95% CI for GMT ratios is \>0.67.~Significance level is α = 2.5% (1-sided), which needs no further adjustment for multiplicity as to reach NI, above hypothesis needs to be rejected for all 3 strains."|Ratio of GMTs|4.67|||||TWO_SIDED|95.0|3.52|6.2|||ANCOVA|||Geometric mean titers (GMTs), in B strain of all three homologous virus strains in Subjects 6 to \< 72 months of Age.||6.20|3.52|
71098361|NCT02255279|141704777|NON_INFERIORITY_OR_EQUIVALENCE|"The following hypotheses should be tested to demonstrate non-inferiority of aTIV to TIV:~H0i: πi1 \> πi2-0.1 vs. H1i: πi1 \> πi2- 0.1 where H0i and H1i represent the null and the alternative hypothesis (respectively) of the non- inferiority objective and πi1 and πi2 represent the seroresponse rates 21 days after last immunization of the aTIV and TIV vaccine groups respectively in the i-th strain (H1N1, H3N2, B). The non-inferiority criterion is -0.1 (i.e., -10%)."|Vaccine Group Differences|17.0|||||TWO_SIDED|95.0|8.1|26.3|||Loglinear model|Binary data were analyzed using loglinear models with a qualitative factor for vaccine group (αik, i = A, B) and center (δlk, k=1).||Percentage of subjects achieving seroconversion in H1N1 strain after last vaccination with aTIV or TIV in naïve and non-naive subjects.||26.3|8.1|
70987235|NCT03151148|141484144|SUPERIORITY||Geometric mean ratio (GMR)|3.62||||0.022|TWO_SIDED|95.0|1.205|10.859|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||10.859|1.205|0.022
70987236|NCT03151148|141484144|SUPERIORITY||Geometric mean ratio (GMR)|4.83||||0.01|TWO_SIDED|95.0|1.458|15.978|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||15.978|1.458|0.010
70987237|NCT03151148|141484144|SUPERIORITY||Geometric mean ratio (GMR)|2.19||||0.169|TWO_SIDED|95.0|0.716|6.692|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||6.692|0.716|0.169
70987238|NCT03151148|141484145|SUPERIORITY||Geometric mean ratio (GMR)|0.176||||0.035|TWO_SIDED|95.0|0.0351|0.8807|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.8807|0.0351|0.035
71008839|NCT03479203|141525317|OTHER|T-Test followed by Bonferroni post-hoc analysis.|Mean Difference (Final Values)|1.96|STANDARD_DEVIATION|1.5||0.05|TWO_SIDED|95.0|1.0|6.0|||t-test, 2 sided|||"Blood assessed for C-reactive protein (CRP), soluble intercellular adhesion molecule (sICAM), the high mobility group box-1 (HMGB1), the NLRP3 inflammasome, and nitrates (NOx for nitric oxide) pre- and post-vaping. CRP, sICAM HMGB1 and NLRP3 is in ng/ml blood and NOx is in nanomol/ml. These numbers were weighted to obtain an inflammation index in blood. This index represents the fold increase over pre-vaping values."||6|1|0.05
71008840|NCT03419741|141525325|OTHER|We plan to enroll 20 participants within one year. Eleven participants were enrolled. 11/20 = 55% completed the number of enrollment.|%|11.0|||||TWO_SIDED||||||percentage|||||||
71008841|NCT01091116|141525368|SUPERIORITY_OR_OTHER|||||||0.5263||95.0|||||ANCOVA|||Tests of Fixed Effects for the primary efficacy variable including baseline treatment and visit (from Visit 3 to Visit 5) as covariates||||0.5263
71008842|NCT04450394|141525382|NON_INFERIORITY|The non-inferiority margin is 0.4%. Non-inferiority is achieved if the upper limit of the 90% Confidence Interval is below 0.4.|LS Mean Difference|0.06|||||TWO_SIDED|90.0|-0.11|0.24||||||||0.24|-0.11|
71008843|NCT00836342|141525386|SUPERIORITY_OR_OTHER|||||||0.31|||||||t-test, 2 sided|||Null hypothesis: There is no difference in mean carotenoid levels between subjects with a history of squamous cell carcinom and control subjects.||||0.31
70987239|NCT03151148|141484145|SUPERIORITY||Geometric mean ratio (GMR)|0.214||||0.06|TWO_SIDED|95.0|0.0427|1.0702|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.0702|0.0427|0.060
70987240|NCT03151148|141484145|SUPERIORITY||Geometric mean ratio (GMR)|0.182||||0.038|TWO_SIDED|95.0|0.0363|0.91|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.9100|0.0363|0.038
70987241|NCT03151148|141484145|SUPERIORITY||Geometric mean ratio (GMR)|0.329||||0.179|TWO_SIDED|95.0|0.065|1.6691|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.6691|0.0650|0.179
70987242|NCT03151148|141484145|SUPERIORITY||Geometric mean ratio (GMR)|0.136||||0.015|TWO_SIDED|95.0|0.0271|0.6805|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.6805|0.0271|0.015
70987243|NCT03151148|141484145|SUPERIORITY||Geometric mean ratio (GMR)|0.302||||0.309|TWO_SIDED|95.0|0.0299|3.0493|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.0493|0.0299|0.309
71008844|NCT00836342|141525387|SUPERIORITY_OR_OTHER|||||||0.49|||||||t-test, 2 sided|||||||0.49
71008845|NCT00836342|141525388|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||t-test, 2 sided|||||||0.09
71008846|NCT02194699|141525389|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate ratio|0.84||||0.4656|TWO_SIDED|95.0|0.53|1.34|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|"Comparison of AAER (rate ratio): Biomarker positive population; Tralo 300 mg Q2W vs placebo.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model."||1.34|0.53|0.4656
71008847|NCT02194699|141525389|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate ratio|1.13||||0.4126|TWO_SIDED|95.0|0.85|1.5|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|"Comparison of AAER (rate ratio): Biomarker negative population; Tralo 300 mg Q2W vs placebo.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model."||1.50|0.85|0.4126
71008848|NCT02194699|141525389|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate reduction|15.83||||0.4656|TWO_SIDED|95.0|-33.71|47.01|||Negative binominal||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|"Comparison of AAER (rate reduction): Biomarker positive population; Tralo 300 mg Q2W vs placebo.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model."||47.01|-33.71|0.4656
70987244|NCT03151148|141484145|SUPERIORITY||Geometric mean ratio (GMR)|0.372||||0.401|TWO_SIDED|95.0|0.0369|3.7569|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.7569|0.0369|0.401
70987245|NCT03151148|141484145|SUPERIORITY||Geometric mean ratio (GMR)|0.591||||0.655|TWO_SIDED|95.0|0.0586|5.9658|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||5.9658|0.0586|0.655
71038198|NCT01243151|141583758|SUPERIORITY_OR_OTHER||LS Mean Difference|11.13|STANDARD_ERROR_OF_MEAN|6.369||0.0858|TWO_SIDED|95.0|-1.62|23.87|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||23.87|-1.62|0.0858
71038199|NCT01243151|141583758|SUPERIORITY_OR_OTHER||LS Mean Difference|7.57|STANDARD_ERROR_OF_MEAN|6.431||0.244|TWO_SIDED|95.0|-5.3|20.44|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||20.44|-5.30|0.2440
71038200|NCT01243151|141583758|SUPERIORITY_OR_OTHER||LS Mean Difference|11.52|STANDARD_ERROR_OF_MEAN|6.249||0.0702|TWO_SIDED|95.0|-0.98|24.03|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||24.03|-0.98|0.0702
71038201|NCT01243151|141583758|SUPERIORITY_OR_OTHER||LS Mean Difference|9.64|STANDARD_ERROR_OF_MEAN|4.878||0.0531|TWO_SIDED|95.0|-0.13|19.41|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||19.41|-0.13|0.0531
71038202|NCT01243151|141583758|SUPERIORITY_OR_OTHER||LS Mean Difference|8.93|STANDARD_ERROR_OF_MEAN|4.94||0.0758|TWO_SIDED|95.0|-0.96|18.83|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||18.83|-0.96|0.0758
71038203|NCT01243151|141583758|SUPERIORITY_OR_OTHER||LS Mean Difference|1.95|STANDARD_ERROR_OF_MEAN|4.975||0.6965|TWO_SIDED|95.0|-8.01|11.92|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||11.92|-8.01|0.6965
71038204|NCT01243151|141583758|SUPERIORITY_OR_OTHER||LS Mean Difference|13.52|STANDARD_ERROR_OF_MEAN|4.842||0.0071|TWO_SIDED|95.0|3.83|23.22|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||23.22|3.83|0.0071
71038205|NCT01243151|141583758|SUPERIORITY_OR_OTHER||LS Mean Difference|11.2|STANDARD_ERROR_OF_MEAN|5.155||0.0339|TWO_SIDED|95.0|0.88|21.52|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||21.52|0.88|0.0339
71038206|NCT01243151|141583758|SUPERIORITY_OR_OTHER||LS Mean Difference|8.56|STANDARD_ERROR_OF_MEAN|5.235||0.1075|TWO_SIDED|95.0|-1.92|19.03|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||19.03|-1.92|0.1075
71038207|NCT01243151|141583758|SUPERIORITY_OR_OTHER||LS Mean Difference|5.98|STANDARD_ERROR_OF_MEAN|5.258||0.2601|TWO_SIDED|95.0|-4.54|16.5|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||16.50|-4.54|0.2601
71038208|NCT01243151|141583758|SUPERIORITY_OR_OTHER||LS Mean Difference|9.96|STANDARD_ERROR_OF_MEAN|5.132||0.057|TWO_SIDED|95.0|-0.31|20.24|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||20.24|-0.31|0.0570
71038209|NCT01243151|141583759|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.88|STANDARD_ERROR_OF_MEAN|5.008|<|0.0001|TWO_SIDED|95.0|-42.93|-22.84|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-22.84|-42.93|<0.0001
71038210|NCT01243151|141583759|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.8|STANDARD_ERROR_OF_MEAN|5.26|<|0.0001|TWO_SIDED|95.0|-41.34|-20.26|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-20.26|-41.34|<0.0001
71038211|NCT01243151|141583759|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.98|STANDARD_ERROR_OF_MEAN|5.088|<|0.0001|TWO_SIDED|95.0|-50.18|-29.77|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.77|-50.18|<0.0001
71038212|NCT01243151|141583759|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.37|STANDARD_ERROR_OF_MEAN|5.07|<|0.0001|TWO_SIDED|95.0|-48.54|-28.2|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-28.20|-48.54|<0.0001
71038213|NCT01243151|141583759|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.18|STANDARD_ERROR_OF_MEAN|6.271|<|0.0001|TWO_SIDED|95.0|-54.73|-29.63|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.63|-54.73|<0.0001
71038214|NCT01243151|141583759|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.69|STANDARD_ERROR_OF_MEAN|6.512|<|0.0001|TWO_SIDED|95.0|-55.72|-29.67|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.67|-55.72|<0.0001
71038215|NCT01243151|141583759|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.56|STANDARD_ERROR_OF_MEAN|6.445|<|0.0001|TWO_SIDED|95.0|-67.45|-41.67|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-41.67|-67.45|<0.0001
71038216|NCT01243151|141583759|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.89|STANDARD_ERROR_OF_MEAN|6.321|<|0.0001|TWO_SIDED|95.0|-64.54|-39.25|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-39.25|-64.54|<0.0001
71038217|NCT01243151|141583759|SUPERIORITY_OR_OTHER||LS Mean Difference|-47.35|STANDARD_ERROR_OF_MEAN|5.359||95|TWO_SIDED|95.0|-58.1|-36.59|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-36.59|-58.10|95
71038218|NCT01243151|141583759|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.08|STANDARD_ERROR_OF_MEAN|5.566|<|0.0001|TWO_SIDED|95.0|-62.24|-39.91|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-39.91|-62.24|<0.0001
71038219|NCT01243151|141583759|SUPERIORITY_OR_OTHER||LS Mean Difference|-59.89|STANDARD_ERROR_OF_MEAN|5.482|<|0.0001|TWO_SIDED|95.0|-70.89|-48.89|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-48.89|-70.89|<0.0001
71038220|NCT01243151|141583759|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.03|STANDARD_ERROR_OF_MEAN|5.377|<|0.0001|TWO_SIDED|95.0|-67.83|-46.24|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-46.24|-67.83|<0.0001
71038221|NCT01243151|141583759|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.06|STANDARD_ERROR_OF_MEAN|5.767|<|0.0001|TWO_SIDED|95.0|-60.61|-37.51|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-37.51|-60.61|<0.0001
71098362|NCT02255279|141704777|NON_INFERIORITY_OR_EQUIVALENCE|"The following hypotheses should be tested to demonstrate non-inferiority of aTIV to TIV:~H0i: πi1 \> πi2-0.1 vs. H1i: πi1 \> πi2- 0.1 where H0i and H1i represent the null and the alternative hypothesis (respectively) of the non- inferiority objective and πi1 and πi2 represent the seroresponse rates 21 days after last immunization of the aTIV and TIV vaccine groups respectively in the i-th strain (H1N1, H3N2, B). The non-inferiority criterion is -0.1 (i.e., -10%)."|Vaccine Group Differences|10.0|||||TWO_SIDED|95.0|-1.8|21.0|||Loglinear model|Binary data were analyzed using loglinear models with a qualitative factor for vaccine group (αik, i = A, B) and center (δlk, k=1).||Percentage of subjects achieving seroconversion in H3N2 strain after last vaccination with aTIV or TIV in naive and non-naive subjects.||21|-1.8|
71038222|NCT01243151|141583759|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.52|STANDARD_ERROR_OF_MEAN|5.974|<|0.0001|TWO_SIDED|95.0|-63.48|-39.56|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-39.56|-63.48|<0.0001
71038223|NCT01243151|141583759|SUPERIORITY_OR_OTHER||LS Mean Difference|-64.22|STANDARD_ERROR_OF_MEAN|5.901|<|0.0001|TWO_SIDED|95.0|-76.04|-52.4|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-52.40|-76.04|<0.0001
71038224|NCT01243151|141583759|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.01|STANDARD_ERROR_OF_MEAN|5.785|<|0.0001|TWO_SIDED|95.0|-71.59|-48.42|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-48.42|-71.59|<0.0001
71038225|NCT01243151|141583760|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.91|STANDARD_ERROR_OF_MEAN|10.392|<|0.0001|TWO_SIDED|95.0|-75.54|-34.29|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-34.29|-75.54|<0.0001
71038226|NCT01243151|141583760|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.07|STANDARD_ERROR_OF_MEAN|10.646|<|0.0001|TWO_SIDED|95.0|-65.21|-22.94|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-22.94|-65.21|<0.0001
71038227|NCT01243151|141583760|SUPERIORITY_OR_OTHER||LS Mean Difference|-67.98|STANDARD_ERROR_OF_MEAN|10.547|<|0.0001|TWO_SIDED|95.0|-88.92|-47.05|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-47.05|-88.92|<0.0001
71038228|NCT01243151|141583760|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.51|STANDARD_ERROR_OF_MEAN|10.381|<|0.0001|TWO_SIDED|95.0|-81.11|-39.9|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-39.90|-81.11|<0.0001
70987246|NCT03151148|141484145|SUPERIORITY||Geometric mean ratio (GMR)|0.43||||0.488|TWO_SIDED|95.0|0.0395|4.6836|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||4.6836|0.0395|0.488
70987247|NCT03151148|141484145|SUPERIORITY||Geometric mean ratio (GMR)|1.485||||0.737|TWO_SIDED|95.0|0.1471|14.9869|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||14.9869|0.1471|0.737
70987248|NCT03151148|141484146|SUPERIORITY||Geometric mean ratio (GMR)|0.248||||0.011|TWO_SIDED|95.0|0.0844|0.7281|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.7281|0.0844|0.011
70987249|NCT03151148|141484146|SUPERIORITY||Geometric mean ratio (GMR)|0.656||||0.44|TWO_SIDED|95.0|0.2245|1.9178|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.9178|0.2245|0.440
71008849|NCT02194699|141525389|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate ratio|1.03||||0.8027|TWO_SIDED|95.0|0.81|1.31|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate ratio): FAS population; Tralo 300 mg Q2W vs placebo.||1.31|0.81|0.8027
71008850|NCT02194699|141525389|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate reduction|-3.14||||0.8027|TWO_SIDED|95.0|-31.46|19.08|||Negative binominal||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate reduction): FAS population; Tralo 300 mg Q2W vs placebo.||19.08|-31.46|0.8027
71038229|NCT01243151|141583760|SUPERIORITY_OR_OTHER||LS Mean Difference|-68.39|STANDARD_ERROR_OF_MEAN|10.392|<|0.0001|TWO_SIDED|95.0|-89.02|-47.76|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-47.76|-89.02|<0.0001
71038230|NCT01243151|141583760|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.41|STANDARD_ERROR_OF_MEAN|10.646|<|0.0001|TWO_SIDED|95.0|-81.54|-39.27|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-39.27|-81.54|<0.0001
71038231|NCT01243151|141583760|SUPERIORITY_OR_OTHER||LS Mean Difference|-86.6|STANDARD_ERROR_OF_MEAN|10.656|<|0.0001|TWO_SIDED|95.0|-107.74|-65.46|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-65.46|-107.74|<0.0001
71038232|NCT01243151|141583760|SUPERIORITY_OR_OTHER||LS Mean Difference|-81.13|STANDARD_ERROR_OF_MEAN|10.381|<|0.0001|TWO_SIDED|95.0|-101.73|-60.52|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-60.52|-101.73|<0.0001
70987250|NCT03151148|141484146|SUPERIORITY||Geometric mean ratio (GMR)|0.479||||0.178|TWO_SIDED|95.0|0.164|1.4007|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.4007|0.1640|0.178
70987251|NCT03151148|141484146|SUPERIORITY||Geometric mean ratio (GMR)|0.478||||0.18|TWO_SIDED|95.0|0.1624|1.4091|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.4091|0.1624|0.180
70987252|NCT03151148|141484146|SUPERIORITY||Geometric mean ratio (GMR)|0.357||||0.06|TWO_SIDED|95.0|0.1222|1.0441|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.0441|0.1222|0.060
71038233|NCT01243151|141583760|SUPERIORITY_OR_OTHER||LS Mean Difference|-80.16|STANDARD_ERROR_OF_MEAN|10.479|<|0.0001|TWO_SIDED|95.0|-100.96|-59.37|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-59.37|-100.96|<0.0001
71038234|NCT01243151|141583760|SUPERIORITY_OR_OTHER||LS Mean Difference|-83.0|STANDARD_ERROR_OF_MEAN|10.646|<|0.0001|TWO_SIDED|95.0|-104.14|-61.87|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-61.87|-104.14|<0.0001
71038235|NCT01243151|141583760|SUPERIORITY_OR_OTHER||LS Mean Difference|-104.77|STANDARD_ERROR_OF_MEAN|10.656|<|0.0001|TWO_SIDED|95.0|-125.91|-83.62|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-83.62|-125.91|<0.0001
71038236|NCT01243151|141583760|SUPERIORITY_OR_OTHER||LS Mean Difference|-90.23|STANDARD_ERROR_OF_MEAN|10.381|<|0.0001|TWO_SIDED|95.0|-110.84|-69.63|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-69.63|-110.84|<0.0001
71038237|NCT01243151|141583760|SUPERIORITY_OR_OTHER||LS Mean Difference|-71.54|STANDARD_ERROR_OF_MEAN|10.479|<|0.0001|TWO_SIDED|95.0|-92.34|-50.75|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-50.75|-92.34|<0.0001
70987253|NCT03151148|141484146|SUPERIORITY||Geometric mean ratio (GMR)|0.498||||0.373|TWO_SIDED|95.0|0.1068|2.3188|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.3188|0.1068|0.373
70987254|NCT03151148|141484146|SUPERIORITY||Geometric mean ratio (GMR)|0.281||||0.106|TWO_SIDED|95.0|0.0604|1.3106|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.3106|0.0604|0.106
70987255|NCT03151148|141484146|SUPERIORITY||Geometric mean ratio (GMR)|1.168||||0.843|TWO_SIDED|95.0|0.2507|5.4434|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||5.4434|0.2507|0.843
70987256|NCT03151148|141484146|SUPERIORITY||Geometric mean ratio (GMR)|1.559||||0.587|TWO_SIDED|95.0|0.3122|7.7818|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||7.7818|0.3122|0.587
71098363|NCT02255279|141704777|NON_INFERIORITY_OR_EQUIVALENCE|"The following hypotheses should be tested to demonstrate non-inferiority of aTIV to TIV:~H0i: πi1 \> πi2-0.1 vs. H1i: πi1 \> πi2- 0.1 where H0i and H1i represent the null and the alternative hypothesis (respectively) of the non- inferiority objective and πi1 and πi2 represent the seroresponse rates 21 days after last immunization of the aTIV and TIV vaccine groups respectively in the i-th strain (H1N1, H3N2, B). The non-inferiority criterion is -0.1 (i.e., -10%)."|Vaccine Group Differences|58.0|||||TWO_SIDED|95.0|47.5|68.5|||Loglinear model|Binary data were analyzed using loglinear models with a qualitative factor for vaccine group (αik, i = A, B) and center (δlk, k=1).||Percentage of subjects achieving seroconversion in B strains after last vaccination with aTIV or TIV in naïve and non naive subjects.||68.5|47.5|
71098364|NCT01524705|141704803|SUPERIORITY||Wilcoxon||||<|0.024||||||Wilcoxon rank sum test was used due to nonnormality distribution|Wilcoxon (Mann-Whitney)|||Two-tailed t test with type I error = 0.05, a sample of 110 participants (55 per group) would give 90% power to detect a difference of a mean change from baseline of 5 CV units (SD = 8) between control and treatment groups. An ANCOVA model, adjusting for baseline value and clinical site, was to be performed. If residual values from the ANCOVA indicated nonnormality in distribution by Shapiro-Wilk testing, a Wilcoxon rank sum test was used instead.||||<0.024
71098365|NCT01524705|141704805|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71098366|NCT01524705|141704806|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
71098367|NCT02123511|141704830|SUPERIORITY|||||||0.1232|||||||t-test, 1 sided|||||||0.1232
71098368|NCT02123511|141704831|SUPERIORITY|||||||0.0422|||||||t-test, 1 sided|||||||0.0422
71098369|NCT02123511|141704832|SUPERIORITY|||||||0.5634|||||||t-test, 1 sided|||||||0.5634
71098370|NCT02123511|141704833|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||||||0.02
71098371|NCT02123511|141704834|SUPERIORITY|||||||0.22|||||||t-test, 1 sided|||||||0.22
71098372|NCT02123511|141704835|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||||||0.02
71098373|NCT02123511|141704836|SUPERIORITY|||||||0.95|||||||t-test, 1 sided|||||||0.95
71098374|NCT02123511|141704837|SUPERIORITY|||||||0.17|||||||t-test, 1 sided|||||||0.17
71098375|NCT02123511|141704838|SUPERIORITY|||||||0.48|||||||t-test, 1 sided|||||||0.48
71098376|NCT02123511|141704839|SUPERIORITY|||||||0.3824|||||||Wilcoxon (Mann-Whitney)|||||||0.3824
71098377|NCT03615534|141704846|SUPERIORITY|||||||0.0001||||||Results were evaluated in terms of adjusted end line TG levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: TG= 240.4 mg/dl, HDL-C = 31.8 mg/dl, ApoA1 = 144.6 mg/dl.||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline TG level as a covariate, with further adjustments for baseline HDL-C, ApoA1levels.||||0.0001
70987257|NCT03151148|141484146|SUPERIORITY||Geometric mean ratio (GMR)|0.707||||0.661|TWO_SIDED|95.0|0.1495|3.3426|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.3426|0.1495|0.661
70987258|NCT03151148|141484147|SUPERIORITY||Geometric mean ratio (GMR)|1197.16|||<|0.001|TWO_SIDED|95.0|525.563|2726.953|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 0 (post-treatment)~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2726.953|525.563|<0.001
70987259|NCT03151148|141484147|SUPERIORITY||Geometric mean ratio (GMR)|779.24|||<|0.001|TWO_SIDED|95.0|342.093|1774.996|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1774.996|342.093|<0.001
70987260|NCT03151148|141484147|SUPERIORITY||Geometric mean ratio (GMR)|673.56|||<|0.001|TWO_SIDED|95.0|295.697|1534.265|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1534.265|295.697|<0.001
70987261|NCT03151148|141484147|SUPERIORITY||Geometric mean ratio (GMR)|60.12|||<|0.001|TWO_SIDED|95.0|24.92|145.027|||Mixed Models Analysis|||"TMT vs Placebo on Lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."|All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|145.027|24.920|<0.001
71038238|NCT01243151|141583760|SUPERIORITY_OR_OTHER||LS Mean Difference|-74.46|STANDARD_ERROR_OF_MEAN|10.646|<|0.0001|TWO_SIDED|95.0|-95.59|-53.32|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-53.32|-95.59|<0.0001
71038239|NCT01243151|141583760|SUPERIORITY_OR_OTHER||LS Mean Difference|-102.35|STANDARD_ERROR_OF_MEAN|10.656|<|0.0001|TWO_SIDED|95.0|-123.49|-81.21|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-81.21|-123.49|<0.0001
71038240|NCT01243151|141583760|SUPERIORITY_OR_OTHER||LS Mean Difference|-87.15|STANDARD_ERROR_OF_MEAN|10.381|<|0.0001|TWO_SIDED|95.0|-107.76|-66.55|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-66.55|-107.76|<0.0001
71038241|NCT01243151|141583761|SUPERIORITY_OR_OTHER||LS Mean Difference|2.01|STANDARD_ERROR_OF_MEAN|1.945||0.3064|TWO_SIDED|95.0|-1.89|5.9|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||5.90|-1.89|0.3064
71038242|NCT01243151|141583761|SUPERIORITY_OR_OTHER||LS Mean Difference|2.67|STANDARD_ERROR_OF_MEAN|2.025||0.1922|TWO_SIDED|95.0|-1.38|6.73|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||6.73|-1.38|0.1922
71038243|NCT01243151|141583761|SUPERIORITY_OR_OTHER||LS Mean Difference|0.82|STANDARD_ERROR_OF_MEAN|1.984||0.6827|TWO_SIDED|95.0|-3.16|4.79|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||4.79|-3.16|0.6827
71038244|NCT01243151|141583761|SUPERIORITY_OR_OTHER||LS Mean Difference|2.45|STANDARD_ERROR_OF_MEAN|1.981||0.2211|TWO_SIDED|95.0|-1.52|6.42|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||6.42|-1.52|0.2211
71038245|NCT01243151|141583761|SUPERIORITY_OR_OTHER||LS Mean Difference|6.64|STANDARD_ERROR_OF_MEAN|2.158||0.0033|TWO_SIDED|95.0|2.31|10.97|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||10.97|2.31|0.0033
70987262|NCT03151148|141484147|SUPERIORITY||Geometric mean ratio (GMR)|3.79||||0.002|TWO_SIDED|95.0|1.636|8.767|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||8.767|1.636|0.002
70987263|NCT03151148|141484147|SUPERIORITY||Geometric mean ratio (GMR)|757.38|||<|0.001|TWO_SIDED|95.0|331.143|1732.242|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 0 (post-treatment)~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1732.242|331.143|<0.001
70987264|NCT03151148|141484147|SUPERIORITY||Geometric mean ratio (GMR)|199.71|||<|0.001|TWO_SIDED|95.0|87.636|455.127|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||455.127|87.636|<0.001
70987265|NCT03151148|141484147|SUPERIORITY||Geometric mean ratio (GMR)|508.45|||<|0.001|TWO_SIDED|95.0|223.113|1158.715|||Mixed Models Analysis|||"TMT vs Placebo on Non-lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."|All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|1158.715|223.113|<0.001
70987266|NCT03151148|141484147|SUPERIORITY||Geometric mean ratio (GMR)|107.86|||<|0.001|TWO_SIDED|95.0|45.568|255.313|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||255.313|45.568|<0.001
70987267|NCT03151148|141484147|SUPERIORITY||Geometric mean ratio (GMR)|16.09|||<|0.001|TWO_SIDED|95.0|7.058|36.657|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||36.657|7.058|<0.001
70987268|NCT03151148|141484148|SUPERIORITY||Geometric mean ratio (GMR)|142.89|||<|0.001|TWO_SIDED|95.0|58.484|349.119|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 0 (post-treatment)~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||349.119|58.484|<0.001
70987269|NCT03151148|141484148|SUPERIORITY||Geometric mean ratio (GMR)|35.19|||<|0.001|TWO_SIDED|95.0|14.402|85.972|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||85.972|14.402|<0.001
70987270|NCT03151148|141484148|SUPERIORITY||Geometric mean ratio (GMR)|41.64|||<|0.001|TWO_SIDED|95.0|17.043|101.739|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||101.739|17.043|<0.001
70987271|NCT03151148|141484148|SUPERIORITY||Geometric mean ratio (GMR)|3.61||||0.008|TWO_SIDED|95.0|1.395|9.33|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||9.330|1.395|0.008
70987272|NCT03151148|141484148|SUPERIORITY||Geometric mean ratio (GMR)|1.39||||0.474|TWO_SIDED|95.0|0.561|3.458|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.458|0.561|0.474
70987273|NCT03151148|141484148|SUPERIORITY||Geometric mean ratio (GMR)|266.87|||<|0.001|TWO_SIDED|95.0|108.86|654.231|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 0 (post-treatment)~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||654.231|108.860|<0.001
70987274|NCT03151148|141484148|SUPERIORITY||Geometric mean ratio (GMR)|51.07|||<|0.001|TWO_SIDED|95.0|20.907|124.768|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||124.768|20.907|<0.001
70987275|NCT03151148|141484148|SUPERIORITY||Geometric mean ratio (GMR)|74.96|||<|0.001|TWO_SIDED|95.0|30.686|183.125|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||183.125|30.686|<0.001
71098378|NCT03615534|141704847|SUPERIORITY|||||||0.06||||||Results were evaluated in terms of adjusted end line TC levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: TC=199.9 mg/dl, Non HDL-C= 168.0 mg/dl, d-LDL-C= 119.1 mg/dl.||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline TC level as a covariate, with further adjustments for baseline Non HDL-C and d-LDL-C.||||0.060
71098379|NCT03615534|141704847|SUPERIORITY|||||||0.0001||||||Results were evaluated in terms of adjusted end line HDL-C levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: HDL-C = 31.8 mg/dL,TG= 240.4 mg/dL, ApoA1 = 144.6 mg/dL.||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline HDL-C level as a covariate, with further adjustments for baselineTG, ApoA1levels.||||0.0001
70987276|NCT03151148|141484148|SUPERIORITY||Geometric mean ratio (GMR)|26.06|||<|0.001|TWO_SIDED|95.0|10.262|66.169|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||66.169|10.262|<0.001
70987277|NCT03151148|141484148|SUPERIORITY||Geometric mean ratio (GMR)|3.41||||0.007|TWO_SIDED|95.0|1.397|8.338|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||8.338|1.397|0.007
70987278|NCT03151148|141484149|SUPERIORITY||Geometric mean ratio (GMR)|51.1|||<|0.001|TWO_SIDED|95.0|21.692|120.379|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 0 (post-treatment)~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||120.379|21.692|<0.001
70987279|NCT03151148|141484149|SUPERIORITY||Geometric mean ratio (GMR)|12.87|||<|0.001|TWO_SIDED|95.0|5.463|30.317|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||30.317|5.463|<0.001
70987280|NCT03151148|141484149|SUPERIORITY||Geometric mean ratio (GMR)|11.46|||<|0.001|TWO_SIDED|95.0|4.863|26.986|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||26.986|4.863|<0.001
70987281|NCT03151148|141484149|SUPERIORITY||Geometric mean ratio (GMR)|2.42||||0.058|TWO_SIDED|95.0|0.971|6.024|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||6.024|0.971|0.058
70987282|NCT03151148|141484149|SUPERIORITY||Geometric mean ratio (GMR)|0.75||||0.526|TWO_SIDED|95.0|0.315|1.805|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.805|0.315|0.526
70987283|NCT03151148|141484149|SUPERIORITY||Geometric mean ratio (GMR)|55.53|||<|0.001|TWO_SIDED|95.0|23.49|131.279|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 0 (post-treatment)~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||131.279|23.490|<0.001
70987284|NCT03151148|141484149|SUPERIORITY||Geometric mean ratio (GMR)|11.78|||<|0.001|TWO_SIDED|95.0|5.0|27.755|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||27.755|5.000|<0.001
70987285|NCT03151148|141484149|SUPERIORITY||Geometric mean ratio (GMR)|23.17|||<|0.001|TWO_SIDED|95.0|9.833|54.579|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||54.579|9.833|<0.001
70987286|NCT03151148|141484149|SUPERIORITY||Geometric mean ratio (GMR)|11.05|||<|0.001|TWO_SIDED|95.0|4.516|27.052|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||27.052|4.516|<0.001
70987287|NCT03151148|141484149|SUPERIORITY||Geometric mean ratio (GMR)|2.43||||0.042|TWO_SIDED|95.0|1.031|5.724|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||5.724|1.031|0.042
70987288|NCT00494871|141484150|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 2.0|Hazard Ratio (HR)|1.11||||0.025|TWO_SIDED|95.0|0.87|1.42|||Regression, Cox|||||1.42|0.87|0.025
70987289|NCT00494871|141484151|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||||TWO_SIDED|95.0|0.24|1.0||||||||1.00|0.24|
70987290|NCT00494871|141484152|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.34|1.22||||||||1.22|0.34|
70987291|NCT00494871|141484153|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.41|1.34||||||||1.34|0.41|
70987292|NCT00494871|141484154|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.22|0.98||||||||0.98|0.22|
70987293|NCT00494871|141484155|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.06|15.85||||||||15.85|0.06|
70987294|NCT00494871|141484156|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.93|||||TWO_SIDED|95.0|0.3|28.16||||||||28.16|0.30|
70987295|NCT00494871|141484157|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.97|||||TWO_SIDED|95.0|0.6|14.7||||||||14.70|0.60|
70987296|NCT00494871|141484158|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.48|||||TWO_SIDED|95.0|0.16|1.4||||||||1.40|0.16|
70987297|NCT00494871|141484159|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.37|||||TWO_SIDED|95.0|0.43|4.31||||||||4.31|0.43|
70987298|NCT00494871|141484160|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.5|1.43||||||||1.43|0.50|
70987299|NCT00494871|141484161|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.92|1.56||||||||1.56|0.92|
70987300|NCT02433210|141484174|SUPERIORITY||||||<|0.001||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 clearance beta 2 microglobilin Optiflux vs Revaclear.||||<0.001
70987301|NCT02433210|141484174|SUPERIORITY||||||<|0.001||||||The p value is not adjusted for multiple comparisons and a p\<0.05 is considered significant.|t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Clearance beta 2 microglobulin Optiflux vs ELISIO.||||<0.001
70987302|NCT02433210|141484174|SUPERIORITY||||||=|0.178||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 clearance beta 2 microglobulin Revaclear vs ELISIO..||||=0.178
70987303|NCT02433210|141484174|SUPERIORITY||||||=|0.016||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Clearance of myoglobin Optiflux vs Revaclear.||||=0.016
70987304|NCT02433210|141484174|SUPERIORITY||||||=|0.033||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Clearance of myoglobin Optiflux vs ELISIO.||||=0.033
70987305|NCT02433210|141484174|SUPERIORITY||||||=|0.935|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Clearance of myoglobin Revaclear vs ELISIO.||||=0.935
70987306|NCT02433210|141484174|SUPERIORITY||||||=|0.463|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of urea nitrogen Optiflux vs Revaclaer.||||=0.463
70987307|NCT02433210|141484174|SUPERIORITY||||||=|0.392|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of urea nitrogen Optiflux vs ELISIO.||||=0.392
70987308|NCT02433210|141484174|SUPERIORITY||||||=|0.597|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance urea nitrogen Revaclear vs ELISIO.||||=0.597
70987309|NCT02433210|141484174|SUPERIORITY||||||=|0.162|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of creatinine Optiflux vs Revaclear.||||=0.162
70987310|NCT02433210|141484174|SUPERIORITY|||||||0.186|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of creatinine Optiflux vs ELISIO.||||0.186
70987311|NCT02433210|141484174|SUPERIORITY|No Significant difference.||||||0.624|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Urea nitrogen clearance Optiflux vs Revaclear.||||0.624
70987312|NCT02433210|141484174|SUPERIORITY|||||||0.732|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Urea nitrogen clearance Optiflux vs ELISIO.||||0.732
70987313|NCT02433210|141484174|SUPERIORITY|||||||0.427|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Urea Nitrogen clearance Revaclear vs Optiflux.||||0.427
70987314|NCT02433210|141484174|SUPERIORITY|||||||0.379|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Creatinine clearance Optiflux vs Revaclear..||||0.379
70987315|NCT02433210|141484174|SUPERIORITY|||||||0.318|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Creatinine clearance Optiflux vs ELISIO.||||0.318
70987316|NCT02433210|141484174|SUPERIORITY||||||=|0.914|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Creatinine clearance Revaclear vs ELISIO.||||=0.914
70987317|NCT02433210|141484174|SUPERIORITY||||||=|0.623|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Phosphate clearance Optiflux vs Revaclear.||||=0.623
70987318|NCT02433210|141484174|SUPERIORITY||||||=|0.403|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Phosphate clearance Optiflux vs ELISIO.||||=0.403
70987319|NCT02433210|141484174|SUPERIORITY||||||=|0.85|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 1 Phosphate clearance Revaclear vs ELISIO.||||=0.850
71098380|NCT03615534|141704847|SUPERIORITY|||||||0.334||||||Results were evaluated in terms of adjusted end line d-LDL-C levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: d-LDL-C= 119.1 mg/dl.TC=199.9 mg/dl, Non HDL-C= 168.0 mg/dl,||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline d-LDL-C level as a covariate, with further adjustments for baseline TC and Non HDL-C .||||0.334
70987320|NCT02433210|141484174|SUPERIORITY||||||=|0.815|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of creatinine Revaclear vs ELISIO.||||=0.815
70987321|NCT02433210|141484174|SUPERIORITY||||||=|0.367|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of Phosphate Optiflux vs Revaclear.||||=0.367
70987322|NCT02433210|141484174|SUPERIORITY||||||=|0.821|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of phosphate Optiflux vs Elisio.||||=0.821
70987323|NCT02433210|141484174|SUPERIORITY||||||=|0.364|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance phosphate Revaclear vs ELISIO.||||=0.364
70987324|NCT02433210|141484174|SUPERIORITY||||||<|0.001||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of beta 2 microglobulin Optiflux vs Revaclear.||||<0.001
70987325|NCT02433210|141484174|SUPERIORITY||||||<|0.001||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of beta 2 microglobulin Optiflux vs ELISIO.||||<0.001
70987326|NCT02433210|141484174|SUPERIORITY||||||=|0.254|||||||t-test, 2 sided|||Session 2 Clearance of beta 2 microglobulin Revaclear vs ELISIO.||||=0.254
70987327|NCT02433210|141484174|SUPERIORITY||||||=|0.079|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of myoglobin Optiflux vs Revaclear.||||=0.079
70987328|NCT02433210|141484174|SUPERIORITY||||||=|0.086|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of myoglobin Optiflux vs ELISIO.||||=0.086
70987329|NCT02433210|141484174|SUPERIORITY||||||=|0.888|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance myoglobin Revaclear vs ELISIO.||||=0.888
70987330|NCT02433210|141484174|SUPERIORITY||||||=|0.663||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of urea nitrogen Optiflux vs Revaclear.||||=0.663
70987331|NCT02433210|141484174|SUPERIORITY||||||=|0.391|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of urea nitrogen Optiflux vs ELISIO.||||=0.391
70987332|NCT02433210|141484174|SUPERIORITY||||||=|0.214|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of urea nitrogen Revaclear vs ELISIO.||||=0.214
70987333|NCT02433210|141484174|SUPERIORITY||||||=|0.918|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of creatinine Optiflux vs Revaclear.||||=0.918
70987334|NCT02433210|141484174|SUPERIORITY||||||=|0.394|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of creatinine Optiflux vs ELISIO.||||=0.394
70987335|NCT02433210|141484174|SUPERIORITY||||||=|0.211|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of creatinine Revaclear vs ELISIO.||||=0.211
70987336|NCT02433210|141484174|SUPERIORITY||||||=|0.222|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of phosphate Optiflux vs ELISIO.||||=0.222
70987337|NCT02433210|141484174|SUPERIORITY||||||=|0.162|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearances of phosphate Revaclear vs ELISIO.||||=0.162
70987338|NCT02433210|141484174|SUPERIORITY||||||<|0.001||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of beta 2 microglobulin Optiflux vs Revaclear.||||<0.001
70987339|NCT02433210|141484174|SUPERIORITY||||||=|0.025||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearances of beta 2 microglobulin Optiflux vs ELISIO.||||=0.025
70987340|NCT02433210|141484174|SUPERIORITY||||||=|0.903|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of beta 2 microglobulin Revaclear vs ELISIO.||||=0.903
70987341|NCT02433210|141484174|SUPERIORITY||||||=|0.003||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearances of myoglobin Optiflux vs Revaclear.||||=0.003
70987342|NCT02433210|141484174|SUPERIORITY||||||<|0.001||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of myoglobin Optiflux vs ELISIO.||||<0.001
71038246|NCT01243151|141583761|SUPERIORITY_OR_OTHER||LS Mean Difference|5.09|STANDARD_ERROR_OF_MEAN|2.237||0.0269|TWO_SIDED|95.0|0.6|9.57|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||9.57|0.60|0.0269
71038247|NCT01243151|141583761|SUPERIORITY_OR_OTHER||LS Mean Difference|3.87|STANDARD_ERROR_OF_MEAN|2.232||0.089|TWO_SIDED|95.0|-0.61|8.34|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||8.34|-0.61|0.0890
70987343|NCT02433210|141484174|SUPERIORITY||||||=|0.472|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of myoglobin Revaclear vs ELISIO.||||=0.472
70987344|NCT02433210|141484175|SUPERIORITY||||||=|0.216||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.216
70987345|NCT02433210|141484175|SUPERIORITY|No significant difference|||||=|0.216||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.216
70987346|NCT02433210|141484175|SUPERIORITY|No significant difference|||||=|0.952||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.952
70987347|NCT02433210|141484175|SUPERIORITY|No Significant difference|||||=|0.714||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.714
70987348|NCT02433210|141484175|SUPERIORITY||||||=|0.156||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.156
70987349|NCT02433210|141484175|SUPERIORITY||||||=|0.427||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.427
70987350|NCT02433210|141484175|SUPERIORITY||||||=|0.487||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||No significant difference||||=0.487
70987351|NCT02433210|141484175|SUPERIORITY|Failed normality test|||||=|0.111||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|The difference in the median values between the two groups is not \> enough to exclude that the difference is due to random sampling variability||No significant difference||||=0.111
70987352|NCT02433210|141484175|SUPERIORITY|Failed normality test|||||=|0.198||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||No significant difference||||=0.198
70987353|NCT02433210|141484175|SUPERIORITY||||||=|0.007||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Showed a significant difference||||=0.007
70987354|NCT02433210|141484175|SUPERIORITY||||||=|0.202||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||No significant difference||||=0.202
70987355|NCT02433210|141484175|SUPERIORITY||||||=|0.54||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||No significant difference||||=0.540
71098381|NCT03615534|141704847|SUPERIORITY|||||||0.012||||||Results were evaluated in terms of adjusted end line Non HDL-C levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: Non HDL-C= 168.0 mg/dl,TC=199.9 mg/dl, d-LDL-C= 119.1 mg/dl.||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline Non HDL-C level as a covariate, with further adjustments for baseline TC and d-LDL-C.||||0.012
70987356|NCT02433210|141484176|SUPERIORITY||||||=|0.204|||||||Wilcoxon (Mann-Whitney)|||||||=0.204
70987357|NCT02433210|141484176|SUPERIORITY||||||=|0.234|||||||Wilcoxon (Mann-Whitney)|||||||=0.234
70987358|NCT02433210|141484176|SUPERIORITY||||||=|0.015||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the \<0.050 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either then the non-parametric Mann-Whitney Rank Sum Test was used.||||||=0.015
70987359|NCT02433210|141484176|SUPERIORITY||||||=|0.413||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.413
70987360|NCT02433210|141484176|SUPERIORITY||||||=|0.314||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.314
70987361|NCT02433210|141484176|SUPERIORITY||||||=|0.769||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.769
70987362|NCT02433210|141484177|SUPERIORITY||||||=|0.376|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.376
70987363|NCT02433210|141484177|SUPERIORITY|||||||1||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||1.000
70987364|NCT02433210|141484177|SUPERIORITY|||||||0.713|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||0.713
70987365|NCT02433210|141484177|SUPERIORITY||||||=|0.424|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.424
70987366|NCT02433210|141484177|SUPERIORITY||||||=|0.23|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.230
70987367|NCT02433210|141484177|SUPERIORITY||||||=|0.678|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.678
70987368|NCT02433210|141484177|SUPERIORITY||||||=|0.643|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.643
70987369|NCT02433210|141484177|SUPERIORITY||||||=|0.43|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.430
70987370|NCT02433210|141484177|SUPERIORITY||||||=|0.295|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.295
70987371|NCT02433210|141484177|SUPERIORITY||||||=|0.723|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.723
70987372|NCT02433210|141484177|SUPERIORITY||||||=|0.749|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.749
70987373|NCT02433210|141484177|SUPERIORITY||||||=|0.967|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.967
70987374|NCT02433210|141484178|SUPERIORITY||||||=|0.67|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.670
70987375|NCT02433210|141484178|SUPERIORITY||||||=|0.993|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.993
70987376|NCT02433210|141484178|SUPERIORITY||||||=|0.65|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.650
70987377|NCT02433210|141484178|SUPERIORITY||||||=|0.299|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.299
70987378|NCT02433210|141484178|SUPERIORITY||||||=|0.659|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.659
70987379|NCT02433210|141484178|SUPERIORITY||||||=|0.176|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.176
71098382|NCT03615534|141704847|SUPERIORITY|||||||0.001||||||Results were evaluated in terms of adjusted end line RC levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values:RC=48.9,TC=199.9, Non HDL-C=168.0, d-LDL-C=119.1, ApoB=133.1mg/dl||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline RC level as a covariate, with further adjustments for baselineTC, Non HDL-C, d-LDL-C, and ApoB.||||0.001
71098383|NCT03615534|141704848|SUPERIORITY|||||||0.058||||||Results were evaluated in terms of adjusted end line ApoA1 levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: ApoA1 = 144.6 mg/dl, TG= 240.4 mg/dl, HDL-C = 31.8 mg/dl.||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline ApoA1 level as a covariate, with further adjustments for baseline TG and HDL-C levels.||||0.058
71098384|NCT03615534|141704848|SUPERIORITY|||||||0.067||||||Results were evaluated in terms of adjusted end line ApoB levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values:ApoB=133.1, RC=48.9,TC=199.9, Non HDL-C=168.0, d-LDL-C=119.1mg/dl||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline ApoB level as a covariate, with further adjustments for baselineTC, Non HDL-C, dLDL-C, and RC .||||0.067
71098385|NCT03615534|141704849|SUPERIORITY|||||||0.001||||||Results were evaluated in terms of adjusted end line FSG levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: FSG= 95.7 mg/dl.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline FSG level as a covariate.||||0.001
71098386|NCT03615534|141704850|SUPERIORITY|||||||0.786||||||Results were evaluated in terms of adjusted end line eGFR levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: eGFR= 88.0 ml/min per 1.73 m\^2.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline eGFR level as a covariate.||||0.786
70987380|NCT02433210|141484178|SUPERIORITY||||||=|0.853|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.853
70987381|NCT02433210|141484178|SUPERIORITY||||||=|0.494|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.494
70987382|NCT02433210|141484178|SUPERIORITY||||||=|0.631|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.631
70987383|NCT02433210|141484178|SUPERIORITY||||||=|0.37|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.370
70987384|NCT02433210|141484178|SUPERIORITY||||||=|0.95|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.950
70987385|NCT02433210|141484178|SUPERIORITY||||||=|0.377|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.377
70987386|NCT02433210|141484179|SUPERIORITY||||||=|0.534|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.534
70987387|NCT02433210|141484179|SUPERIORITY||||||=|0.578|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.578
71098387|NCT03615534|141704851|SUPERIORITY|||||||0.0001||||||Results were evaluated in terms of adjusted end line serum uric acid levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: serum uric acid= 5.0 mg/dl.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline serum uric acid level as a covariate.||||0.0001
71098388|NCT03615534|141704852|OTHER|||||||0.201||||||Results were evaluated in terms of adjusted end line AST levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|"Covariates appearing in ANCOVA model are evaluated at the following baseline values: AST= 18.1 IU/L.~."||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline AST level as a covariate.||||0.201
71098389|NCT03615534|141704852|SUPERIORITY|||||||0.033||||||Results were evaluated in terms of adjusted end line ALT levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: ALT= 16.0 IU/L.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline ALT level as a covariate.||||0.033
70987388|NCT02433210|141484179|SUPERIORITY||||||=|0.225|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.225
70987389|NCT02433210|141484179|SUPERIORITY||||||=|0.125|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.125
70987390|NCT02433210|141484179|SUPERIORITY||||||=|0.466|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.466
70987391|NCT02433210|141484179|SUPERIORITY||||||=|0.534|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.534
70987392|NCT02433210|141484179|SUPERIORITY||||||=|0.584|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.584
70987393|NCT02433210|141484179|SUPERIORITY||||||=|0.981|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.981
71098390|NCT03615534|141704852|SUPERIORITY|||||||0.511||||||Results were evaluated in terms of adjusted end line CK levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: CK= 28.0 IU/L.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline CK level as a covariate.||||0.511
71098391|NCT03615534|141704853|OTHER|||||||0.434||||||Results were evaluated in terms of adjusted end line diastolic blood pressure levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: diastolic blood pressure= 80.0 mmHg.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline diastolic blood pressure level as a covariate.||||0.434
71098392|NCT03615534|141704853|SUPERIORITY|||||||0.966||||||Results were evaluated in terms of adjusted end line systolic blood pressure levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: systolic blood pressure= 121.5 mmHg.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline systolic blood pressure level as a covariate.||||0.966
71098393|NCT00604383|141704855|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.034
71098394|NCT01750281|141704864|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A hazard ratio \<1 favours selumetinib in combination with docetaxel|Hazard Ratio (HR)|1.12||||0.584|TWO_SIDED|90.0|0.8|1.61|||Cox Proportional Hazards|||||1.61|0.80|0.584
71098395|NCT01750281|141704864|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A hazard ratio \<1 favours selumetinib in combination with docetaxel|Hazard Ratio (HR)|0.92||||0.69|TWO_SIDED|90.0|0.65|1.31|||Cox Proportional Hazards|||||1.31|0.65|0.690
70987394|NCT02433210|141484179|SUPERIORITY||||||=|0.568|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.568
70987395|NCT02433210|141484179|SUPERIORITY||||||=|0.24|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.240
70987396|NCT02433210|141484179|SUPERIORITY||||||=|0.724|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.724
70987397|NCT02433210|141484179|SUPERIORITY||||||=|0.445|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.445
70987398|NCT02433210|141484180|SUPERIORITY||||||=|0.114|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.114
70987399|NCT02433210|141484180|SUPERIORITY||||||=|0.292|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.292
70987400|NCT02433210|141484180|SUPERIORITY||||||=|0.714|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.714
70987401|NCT02433210|141484180|SUPERIORITY||||||=|0.176|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.176
70987402|NCT02433210|141484180|SUPERIORITY||||||=|0.19|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.190
70987403|NCT02433210|141484180|SUPERIORITY|||||||-0.009|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||-0.009
70987404|NCT02433210|141484180|SUPERIORITY||||||=|0.911|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.911
70987405|NCT02433210|141484180|SUPERIORITY||||||=|0.388|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.388
70987406|NCT02433210|141484180|SUPERIORITY||||||=|0.337|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.337
70987407|NCT02433210|141484180|SUPERIORITY||||||=|0.575|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.575
70987408|NCT02433210|141484180|SUPERIORITY||||||=|0.88|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.880
70987409|NCT02433210|141484180|SUPERIORITY||||||=|0.731|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.731
70987410|NCT03046472|141484193|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
70987411|NCT03046472|141484194|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
70987412|NCT03046472|141484195|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
70987413|NCT01958671|141484205|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.99|||<|0.001|TWO_SIDED|95.0|-1.22|-0.76|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-0.76|-1.22|<0.001
70987414|NCT01958671|141484205|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.16|||<|0.001|TWO_SIDED|95.0|-1.39|-0.93|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-0.93|-1.39|<0.001
70987415|NCT01958671|141484206|SUPERIORITY_OR_OTHER||Difference in percentage|-2.6|||||TWO_SIDED|95.0|-13.1|8.1|||||Based on Miettinen \& Nurminen method.|||8.1|-13.1|
70987416|NCT01958671|141484206|SUPERIORITY_OR_OTHER||Difference in percentage|-4.2|||||TWO_SIDED|95.0|-14.8|6.6|||||Based on Miettinen \& Nurminen method.|||6.6|-14.8|
70987417|NCT01958671|141484207|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0|||||TWO_SIDED|95.0|-7.7|3.3|||||Based on Miettinen \& Nurminen method.|||3.3|-7.7|
70987418|NCT01958671|141484207|SUPERIORITY_OR_OTHER||Difference in percentage|-2.6|||||TWO_SIDED|95.0|-8.2|2.7|||||Based on Miettinen \& Nurminen method.|||2.7|-8.2|
70987419|NCT01958671|141484208|SUPERIORITY_OR_OTHER||Difference in least squares means|-34.53|||<|0.001|TWO_SIDED|95.0|-42.76|-26.29|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-26.29|-42.76|<0.001
70987420|NCT01958671|141484208|SUPERIORITY_OR_OTHER||Difference in least squares means|-44.01|||<|0.001|TWO_SIDED|95.0|-52.28|-35.74|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-35.74|-52.28|<0.001
70987421|NCT01958671|141484209|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.76|||<|0.001|TWO_SIDED|95.0|-2.57|-0.95|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-0.95|-2.57|<0.001
70987422|NCT01958671|141484209|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.16|||<|0.001|TWO_SIDED|95.0|-2.98|-1.34|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-1.34|-2.98|<0.001
70987423|NCT01958671|141484210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.59|||<|0.001|TWO_SIDED|95.0|1.85|6.95|||Regression, Logistic|Fixed effects for treatment, prior antihyperglycemic medication, covariates for baseline A1C and baseline eGFR.||||6.95|1.85|<0.001
70987424|NCT01958671|141484210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.77|||<|0.001|TWO_SIDED|95.0|3.46|13.24|||Regression, Logistic|Fixed effects for treatment, prior antihyperglycemic medication, covariates for baseline A1C and baseline||||13.24|3.46|<0.001
70987425|NCT01958671|141484212|SUPERIORITY_OR_OTHER||Difference in least squares means|-69.03|||<|0.001|TWO_SIDED|95.0|-83.24|-54.83|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-54.83|-83.24|<0.001
70987426|NCT01958671|141484212|SUPERIORITY_OR_OTHER||Difference in least squares means|-67.33|||<|0.001|TWO_SIDED|95.0|-81.73|-52.93|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-52.93|-81.73|<0.001
70987427|NCT01958671|141484214|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.31||||0.015|TWO_SIDED|95.0|-5.98|-0.65||Nominal p-value|Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-0.65|-5.98|0.015
70987428|NCT01958671|141484214|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.71||||0.213|TWO_SIDED|95.0|-4.4|0.98|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||0.98|-4.40|0.213
70987429|NCT01958671|141484216|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|-1.8||||0.039|TWO_SIDED|95.0|-3.51|-0.09||Nominal p-value|Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-0.09|-3.51|0.039
70987430|NCT01958671|141484216|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.37||||0.669|TWO_SIDED|95.0|-2.09|1.35||Nominal p-value|Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||1.35|-2.09|0.669
70987431|NCT01993329|141484217|SUPERIORITY||Geometric means ratio|1.108||||0.616|TWO_SIDED|95.0|0.734|1.673|||ANOVA||Analysis was based on an ANOVA model with log (base 2) PC20 methacholine challenge at each period as dependent variable, treatment and period as fixed effects and participant as random effect.|||1.673|0.734|0.616
70987432|NCT01993329|141484217|SUPERIORITY||Geometric means ratio|1.016||||0.939|TWO_SIDED|95.0|0.673|1.534|||ANOVA||Analysis was based on an ANOVA model with log (base 2) PC20 methacholine challenge at each period as dependent variable, treatment and period as fixed effects and participant as random effect.|||1.534|0.673|0.939
70987433|NCT01993329|141484217|SUPERIORITY||Geometric means ratio|0.917||||0.671|TWO_SIDED|95.0|0.607|1.384|||ANOVA||Analysis was based on an ANOVA model with log (base 2) PC20 methacholine challenge at each period as dependent variable, treatment and period as fixed effects and participant as random effect.|||1.384|0.607|0.671
70987434|NCT01993329|141484218|SUPERIORITY||Mean Difference (Final Values)|-0.111||||0.066|TWO_SIDED|95.0|-0.23|0.008|||ANOVA||Analysis is based on an ANOVA model with minimum highest FEV1 after methacholine challenge at each period as dependent variable, treatment and period as fixed effects and participant as random effect.|||0.008|-0.230|0.066
70987435|NCT01993329|141484218|SUPERIORITY||Mean Difference (Final Values)|-0.012||||0.843|TWO_SIDED|95.0|-0.131|0.107|||ANOVA||Analysis is based on an ANOVA model with minimum highest FEV1 after methacholine challenge at each period as dependent variable, treatment and period as fixed effects and participant as random effect|||0.107|-0.131|0.843
70987436|NCT01993329|141484218|SUPERIORITY||Mean Difference (Final Values)|-0.099||||0.098|TWO_SIDED|95.0|-0.218|0.02|||ANOVA||Analysis is based on an ANOVA model with minimum highest FEV1 after methacholine challenge at each period as dependent variable, treatment and period as fixed effects and participant as random effect|||0.020|-0.218|0.098
70987437|NCT02948777|141484219|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70987438|NCT02948777|141484220|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70987439|NCT02948777|141484221|OTHER|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
70987440|NCT02948777|141484222|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70987441|NCT02948777|141484223|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70987442|NCT02948777|141484224|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70987443|NCT02948777|141484225|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
70987444|NCT02948777|141484226|OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
70987445|NCT02948777|141484227|OTHER|||||||0.31|||||||Kruskal-Wallis|||||||0.31
70987446|NCT02948777|141484228|OTHER|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||||||0.61
70987447|NCT02948777|141484229|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
70987448|NCT02948777|141484230|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
70987449|NCT02948777|141484231|OTHER|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||||||0.027
70987450|NCT02948777|141484232|OTHER|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||||||0.84
70987451|NCT02948777|141484233|OTHER|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||||||0.59
70987452|NCT02948777|141484234|OTHER|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||||||0.81
70987453|NCT02948777|141484235|OTHER|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
70987454|NCT02948777|141484236|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
70987455|NCT02948777|141484237|OTHER|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
70987456|NCT02948777|141484238|OTHER|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
70987457|NCT02948777|141484239|OTHER|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
70987458|NCT02948777|141484240|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
70987459|NCT02948777|141484242|OTHER|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||||||0.84
70987460|NCT02948777|141484243|OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
70987461|NCT02311478|141484244|OTHER|Given that this is a observational cohort design we do not use either non-inferiority or equivalence analysis. Using ANOVA we test for differences in the number of days per month of bleeding between the 90 days pre-insertion, the 90 days following insertion, and 91-180 days following insertion.|Mean Difference (Net)|1.77|STANDARD_ERROR_OF_MEAN|0.28|<|0.05|TWO_SIDED|95.0|1.2|2.3||The p-value is not adjusted for multiple comparisons.|ANOVA|df=2||The null hypothesis is that there is no difference between the number of days of bleeding per month at baseline and the days of bleeding per month during 90 days after insertion, and months or 91-180 days following insertion.||2.3|1.2|<0.05
70987462|NCT02311478|141484244|EQUIVALENCE|α of 0.05 or lower.|Mean Difference (Final Values)|0.93|||<|0.05|TWO_SIDED|95.0|0.36|1.5|||t-test, 2 sided|||The estimation parameter compares the 90 days following to the 90 days prior.||1.5|0.36|<0.05
70987463|NCT03242928|141484247|SUPERIORITY||Mean Difference (Final Values)|-0.087|STANDARD_ERROR_OF_MEAN|0.037|=|0.021|TWO_SIDED|95.0|-0.161|-0.013|||ANCOVA|||||-0.013|-0.161|= 0.021
70987464|NCT03242928|141484248|SUPERIORITY||Mean Difference (Final Values)|-0.177|STANDARD_ERROR_OF_MEAN|0.077|=|0.025|TWO_SIDED|95.0|-0.331|-0.023|||ANOVA|||||-0.023|-0.331|= 0.025
70987465|NCT03242928|141484249|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.038|=|0.072|TWO_SIDED|95.0|-0.146|0.006|||ANCOVA|||||0.006|-0.146|= 0.072
70987466|NCT03691623|141484261|SUPERIORITY||LS Mean Difference|-588.08|||<|0.001|TWO_SIDED|95.0|-719.8|-456.35|||ANCOVA|||||-456.35|-719.8|< 0.001
70987467|NCT03691623|141484261|SUPERIORITY||LS Mean Difference|-564.63|||<|0.001|TWO_SIDED|95.0|-689.23|-440.02|||ANCOVA|||||-440.02|-689.23|< 0.001
70987468|NCT03691623|141484261|SUPERIORITY||LS Mean Difference|-716.08|||<|0.001|TWO_SIDED|95.0|-879.92|-552.24|||ANCOVA|||||-552.24|-879.92|< 0.001
70987469|NCT03691623|141484261|SUPERIORITY||LS Mean Difference|-736.23|||<|0.001|TWO_SIDED|95.0|-916.36|-556.11|||ANCOVA|||||-556.11|-916.36|< 0.001
70987470|NCT03691623|141484262|SUPERIORITY||LS Mean Difference|-355.91|||<|0.001|TWO_SIDED|95.0|-506.12|-205.69|||ANCOVA|||||-205.69|-506.12|< 0.001
71038248|NCT01243151|141583761|SUPERIORITY_OR_OTHER||LS Mean Difference|5.08|STANDARD_ERROR_OF_MEAN|2.19||0.0242|TWO_SIDED|95.0|0.69|9.47|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||9.47|0.69|0.0242
71038249|NCT01243151|141583761|SUPERIORITY_OR_OTHER||LS Mean Difference|3.25|STANDARD_ERROR_OF_MEAN|2.101||0.127|TWO_SIDED|95.0|-0.95|7.46|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||7.46|-0.95|0.1270
71038250|NCT01243151|141583761|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|2.151||0.1199|TWO_SIDED|95.0|-0.91|7.7|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||7.70|-0.91|0.1199
71038251|NCT01243151|141583761|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|2.15||0.8123|TWO_SIDED|95.0|-3.79|4.82|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||4.82|-3.79|0.8123
71038252|NCT01243151|141583761|SUPERIORITY_OR_OTHER||LS Mean Difference|5.65|STANDARD_ERROR_OF_MEAN|2.106||0.0095|TWO_SIDED|95.0|1.44|9.87|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||9.87|1.44|0.0095
71038253|NCT01243151|141583761|SUPERIORITY_OR_OTHER||LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|2.492||0.1141|TWO_SIDED|95.0|-0.99|8.99|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||8.99|-0.99|0.1141
71038254|NCT01243151|141583761|SUPERIORITY_OR_OTHER||LS Mean Difference|3.65|STANDARD_ERROR_OF_MEAN|2.536||0.1552|TWO_SIDED|95.0|-1.42|8.73|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||8.73|-1.42|0.1552
71038255|NCT01243151|141583761|SUPERIORITY_OR_OTHER||LS Mean Difference|1.57|STANDARD_ERROR_OF_MEAN|2.547||0.5407|TWO_SIDED|95.0|-3.53|6.67|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||6.67|-3.53|0.5407
70987471|NCT03691623|141484262|SUPERIORITY||LS Mean Difference|-326.64|||<|0.001|TWO_SIDED|95.0|-469.68|-183.6|||ANCOVA|||||-183.6|-469.68|< 0.001
71038256|NCT01243151|141583761|SUPERIORITY_OR_OTHER||LS Mean Difference|6.56|STANDARD_ERROR_OF_MEAN|2.485||0.0107|TWO_SIDED|95.0|1.58|11.53|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||11.53|1.58|0.0107
71038257|NCT01243151|141583762|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.35|STANDARD_ERROR_OF_MEAN|8.152|<|0.0001|TWO_SIDED|95.0|-76.74|-43.97|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-43.97|-76.74|<0.0001
71038258|NCT01243151|141583762|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.53|STANDARD_ERROR_OF_MEAN|8.422|<|0.0001|TWO_SIDED|95.0|-69.45|-35.61|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-35.61|-69.45|<0.0001
71038259|NCT01243151|141583762|SUPERIORITY_OR_OTHER||LS Mean Difference|-69.46|STANDARD_ERROR_OF_MEAN|8.26|<|0.0001|TWO_SIDED|95.0|-86.06|-52.86|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-52.86|-86.06|<0.0001
71038260|NCT01243151|141583762|SUPERIORITY_OR_OTHER||LS Mean Difference|-66.25|STANDARD_ERROR_OF_MEAN|8.112|<|0.0001|TWO_SIDED|95.0|-82.55|-49.94|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-49.94|-82.55|<0.0001
71038261|NCT01243151|141583762|SUPERIORITY_OR_OTHER||LS Mean Difference|-78.46|STANDARD_ERROR_OF_MEAN|10.766|<|0.0001|TWO_SIDED|95.0|-100.05|-56.87|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-56.87|-100.05|<0.0001
71038262|NCT01243151|141583762|SUPERIORITY_OR_OTHER||LS Mean Difference|-71.28|STANDARD_ERROR_OF_MEAN|11.051|<|0.0001|TWO_SIDED|95.0|-93.43|-49.13|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-49.13|-93.43|<0.0001
71098396|NCT01750281|141704865|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A hazard ratio \<1 favours selumetinib in combination with docetaxel|Hazard Ratio (HR)|1.43||||0.126|TWO_SIDED|90.0|0.97|2.13|||Cox Proportional Hazards|||||2.13|0.97|0.126
70987472|NCT03691623|141484262|SUPERIORITY||LS Mean Difference|-313.98|||=|0.001|TWO_SIDED|95.0|-494.27|-133.69|||ANCOVA|||||-133.69|-494.27|= 0.001
70987473|NCT03691623|141484262|SUPERIORITY||LS Mean Difference|-312.73|||=|0.003|TWO_SIDED|95.0|-508.05|-117.4|||ANCOVA|||||-117.4|-508.05|= 0.003
70987474|NCT03691623|141484263|SUPERIORITY||LS Mean Difference|-3.7|||<|0.001|TWO_SIDED|95.0|-5.3|-2.0|||ANCOVA|||||-2|-5.3|< 0.001
70987475|NCT03691623|141484263|SUPERIORITY||LS Mean Difference|-3.9|||<|0.001|TWO_SIDED|95.0|-5.5|-2.4|||ANCOVA|||||-2.4|-5.5|< 0.001
70987476|NCT03691623|141484263|SUPERIORITY||LS Mean Difference|-3.0|||=|0.002|TWO_SIDED|95.0|-4.9|-1.2|||ANCOVA|||||-1.2|-4.9|= 0.002
70987477|NCT03691623|141484263|SUPERIORITY||LS Mean Difference|-2.9|||=|0.006|TWO_SIDED|95.0|-4.9|-0.9|||ANCOVA|||||-0.9|-4.9|= 0.006
70987478|NCT03691623|141484265|SUPERIORITY||LS Mean Difference|-0.82|||=|0.199|TWO_SIDED|95.0|-2.09|0.44|||ANCOVA|||||0.44|-2.09|= 0.199
70987479|NCT03691623|141484265|SUPERIORITY||LS Mean Difference|0.22|||=|0.714|TWO_SIDED|95.0|-0.98|1.43|||ANCOVA|||||1.43|-0.98|= 0.714
70987480|NCT03691623|141484265|SUPERIORITY||LS Mean Difference|-0.19|||=|0.844|TWO_SIDED|95.0|-2.15|1.77|||ANCOVA|||||1.77|-2.15|= 0.844
70987481|NCT03691623|141484265|SUPERIORITY||LS Mean Difference|-1.34|||=|0.21|TWO_SIDED|95.0|-3.46|0.79|||ANCOVA|||||0.79|-3.46|= 0.21
70987482|NCT03691623|141484266|SUPERIORITY||LS Mean Difference|-1.01|||=|0.145|TWO_SIDED|95.0|-2.37|0.36|||ANCOVA|||||0.36|-2.37|= 0.145
70987483|NCT03691623|141484266|SUPERIORITY||LS Mean Difference|-0.65|||=|0.352|TWO_SIDED|95.0|-2.03|0.73|||ANCOVA|||||0.73|-2.03|= 0.352
70987484|NCT03691623|141484266|SUPERIORITY||LS Mean Difference|-2.85|||=|0.002|TWO_SIDED|95.0|-4.55|-1.15|||ANCOVA|||||-1.15|-4.55|= 0.002
70987485|NCT03691623|141484266|SUPERIORITY||LS Mean Difference|-3.4|||<|0.001|TWO_SIDED|95.0|-5.19|-1.61|||ANCOVA|||||-1.61|-5.19|< 0.001
70987486|NCT03691623|141484267|SUPERIORITY||LS Mean Difference|-24.081|||<|0.001|TWO_SIDED|95.0|-36.554|-11.607|||ANCOVA|||||-11.607|-36.554|< 0.001
70987487|NCT03691623|141484267|SUPERIORITY||LS Mean Difference|-25.954|||<|0.001|TWO_SIDED|95.0|-37.695|-14.213|||ANCOVA|||||-14.213|-37.695|< 0.001
70987488|NCT03691623|141484267|SUPERIORITY||LS Mean Difference|-18.13|||<|0.001|TWO_SIDED|95.0|-27.176|-9.083|||ANCOVA|||||-9.083|-27.176|< 0.001
70987489|NCT03691623|141484267|SUPERIORITY||LS Mean Difference|-19.329|||<|0.001|TWO_SIDED|95.0|-29.106|-9.552|||ANCOVA|||||-9.552|-29.106|< 0.001
70987490|NCT03691623|141484268|SUPERIORITY||LS Mean Difference|-2.1292|||<|0.001|TWO_SIDED|95.0|-2.8491|-1.4093|||ANCOVA|||||-1.4093|-2.8491|< 0.001
70987491|NCT03691623|141484268|SUPERIORITY||LS Mean Difference|-2.1129|||<|0.001|TWO_SIDED|95.0|-2.7938|-1.4319|||ANCOVA|||||-1.4319|-2.7938|< 0.001
70987492|NCT03691623|141484268|SUPERIORITY||LS Mean Difference|-3.2191|||<|0.001|TWO_SIDED|95.0|-4.1915|-2.2467|||ANCOVA|||||-2.2467|-4.1915|< 0.001
70987493|NCT03691623|141484268|SUPERIORITY||LS Mean Difference|-2.7831|||<|0.001|TWO_SIDED|95.0|-3.8522|-1.714|||ANCOVA|||||-1.714|-3.8522|< 0.001
70987494|NCT03691623|141484269|SUPERIORITY||LS Mean Difference|-2.01|||<|0.001|TWO_SIDED|95.0|-2.67|-1.35|||ANCOVA|||||-1.35|-2.67|< 0.001
70987495|NCT03691623|141484269|SUPERIORITY||LS Mean Difference|-1.78|||<|0.001|TWO_SIDED|95.0|-2.4|-1.16|||ANCOVA|||||-1.16|-2.4|< 0.001
70987496|NCT03691623|141484269|SUPERIORITY||LS Mean Difference|-1.98|||=|0.009|TWO_SIDED|95.0|-3.43|-0.54|||ANCOVA|||||-0.54|-3.43|= 0.009
70987497|NCT03691623|141484269|SUPERIORITY||LS Mean Difference|-2.41|||=|0.004|TWO_SIDED|95.0|-4.0|-0.82|||ANCOVA|||||-0.82|-4|= 0.004
70987498|NCT03691623|141484270|SUPERIORITY||LS Mean Difference|-2.1|||<|0.001|TWO_SIDED|95.0|-3.04|-1.17|||ANCOVA|||||-1.17|-3.04|< 0.001
70987499|NCT03691623|141484270|SUPERIORITY||LS Mean Difference|-2.0|||<|0.001|TWO_SIDED|95.0|-2.89|-1.11|||ANCOVA|||||-1.11|-2.89|< 0.001
70987500|NCT03691623|141484270|SUPERIORITY||LS Mean Difference|-1.97|||<|0.001|TWO_SIDED|95.0|-3.06|-0.89|||ANCOVA|||||-0.89|-3.06|< 0.001
70987501|NCT03691623|141484270|SUPERIORITY||LS Mean Difference|-2.46|||<|0.001|TWO_SIDED|95.0|-3.64|-1.29|||ANCOVA|||||-1.29|-3.64|< 0.001
70987502|NCT03691623|141484271|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||< 0.001
70987503|NCT03691623|141484271|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||< 0.001
70987504|NCT03691623|141484271|SUPERIORITY||||||=|0.001|||||||Log Rank|||||||= 0.001
70987505|NCT03691623|141484271|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||< 0.001
70987506|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.903||||0.0126|TWO_SIDED|95.0|0.833|0.978|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.978|0.833|0.0126
70987507|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.966||||0.0042|TWO_SIDED|95.0|0.944|0.989|||Regression, Logistic|||The statistical analysis is presented for Body Mass Index (BMI) in kilogram per square meter (kg/m\^2). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.989|0.944|0.0042
70987508|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.732|||<|0.0001|TWO_SIDED|95.0|0.656|0.816|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at Baseline (BL) in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.816|0.656|<0.0001
70987509|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.686|||<|0.0001|TWO_SIDED|95.0|1.347|2.109|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.109|1.347|<0.0001
70987510|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.103||||0.4759|TWO_SIDED|95.0|0.843|1.442|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missed vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.442|0.843|0.4759
71098397|NCT01750281|141704865|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A hazard ratio \<1 favours selumetinib in combination with docetaxel|Hazard Ratio (HR)|1.18||||0.485|TWO_SIDED|90.0|0.8|1.78|||Cox Proportional Hazards|||||1.78|0.80|0.485
70987511|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.656||||0.018|TWO_SIDED|95.0|0.462|0.93|||Regression, Logistic|||The statistical analysis is presented for Alanine transaminase (ALT) ratio at BL (\<=1 vs \> 3). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.930|0.462|0.0180
70987512|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.742||||0.0262|TWO_SIDED|95.0|0.57|0.965|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\> 1 - 3 vs \> 3). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.965|0.570|0.0262
70987513|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.717||||0.0069|TWO_SIDED|95.0|0.563|0.913|||Regression, Logistic|||The statistical analysis is presented for aspartate aminotransferase (AST) ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.913|0.563|0.0069
70987514|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.062|||<|0.0001|TWO_SIDED|95.0|1.056|1.067|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.067|1.056|<0.0001
70987515|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.107||||0.0062|TWO_SIDED|95.0|1.029|1.191|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.191|1.029|0.0062
70987516|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.739||||0.0295|TWO_SIDED|95.0|0.563|0.97|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.970|0.563|0.0295
70987517|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.166|||<|0.0001|TWO_SIDED|95.0|0.083|0.329|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.329|0.083|<0.0001
70987518|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.049||||0.0048|TWO_SIDED|95.0|1.015|1.084|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.084|1.015|0.0048
70987519|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.797||||0.0019|TWO_SIDED|95.0|2.136|28.458|||Regression, Logistic|||The statistical analysis is presented for cumulative PEG-IFN alfa-2a dose per 1000 ug, first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||28.458|2.136|0.0019
70987520|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.638||||0.0255|TWO_SIDED|95.0|0.431|0.946|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.946|0.431|0.0255
70987521|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.755||||0.0059|TWO_SIDED|95.0|0.618|0.922|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.922|0.618|0.0059
70987522|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.521||||0.0005|TWO_SIDED|95.0|1.501|4.236|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||4.236|1.501|0.0005
70987523|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.602||||0.0011|TWO_SIDED|95.0|1.463|4.627|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missed vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||4.627|1.463|0.0011
70987524|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.727||||0.0034|TWO_SIDED|95.0|1.198|2.491|||Regression, Logistic|||The statistical analysis is presented for mode of infection (other vs injection drug U). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.491|1.198|0.0034
70987525|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.545||||0.0014|TWO_SIDED|95.0|0.376|0.792|||Regression, Logistic|||The statistical analysis is presented for AST ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.792|0.376|0.0014
70987526|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.047|||<|0.0001|TWO_SIDED|95.0|1.029|1.065|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.065|1.029|<0.0001
70987527|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.896||||0.0074|TWO_SIDED|95.0|0.827|0.971|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.971|0.827|0.0074
70987528|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.971||||0.0088|TWO_SIDED|95.0|0.95|0.993|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.993|0.950|0.0088
70987529|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.719|||<|0.0001|TWO_SIDED|95.0|0.643|0.803|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.803|0.643|<0.0001
70987530|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.683|||<|0.0001|TWO_SIDED|95.0|1.346|2.106|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.106|1.346|<0.0001
70987531|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.4479|TWO_SIDED|95.0|0.848|1.453|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.453|0.848|0.4479
70987532|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.0123|TWO_SIDED|95.0|0.451|0.908|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\<=1 vs \> 3). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.908|0.451|0.0123
70987533|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.0147|TWO_SIDED|95.0|0.553|0.937|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\> 1 - 3 vs \> 3). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.937|0.553|0.0147
70987534|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.718||||0.0071|TWO_SIDED|95.0|0.564|0.914|||Regression, Logistic|||The statistical analysis is presented for AST ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.914|0.564|0.0071
70987535|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.058|||<|0.0001|TWO_SIDED|95.0|1.052|1.064|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.064|1.052|<0.0001
71038263|NCT01243151|141583762|SUPERIORITY_OR_OTHER||LS Mean Difference|-91.83|STANDARD_ERROR_OF_MEAN|11.018|<|0.0001|TWO_SIDED|95.0|-113.92|-69.74|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-69.74|-113.92|<0.0001
71038264|NCT01243151|141583762|SUPERIORITY_OR_OTHER||LS Mean Difference|-89.5|STANDARD_ERROR_OF_MEAN|10.736|<|0.0001|TWO_SIDED|95.0|-111.03|-67.97|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-67.97|-111.03|<0.0001
71038265|NCT01243151|141583762|SUPERIORITY_OR_OTHER||LS Mean Difference|-86.73|STANDARD_ERROR_OF_MEAN|8.452|<|0.0001|TWO_SIDED|95.0|-103.73|-69.72|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-69.72|-103.73|<0.0001
71038266|NCT01243151|141583762|SUPERIORITY_OR_OTHER||LS Mean Difference|-92.18|STANDARD_ERROR_OF_MEAN|8.643|<|0.0001|TWO_SIDED|95.0|-109.57|-74.8|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-74.80|-109.57|<0.0001
71098398|NCT01122680|141704914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.039||0.0043||95.0|0.036|0.19||First step of closed testing procedure, where the active treatments are compared to placebo. If this statisical test significant at the 0.05 alpha level then proceed to comparison of the next lower dose to placebo.|Mixed model repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R5 minus Placebo||0.190|0.036|0.0043
71098399|NCT01122680|141704914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.039||0.1484||95.0|-0.021|0.135||Second step of closed testing procedure. If this statisical test significant at the 0.05 alpha level then proceed to comparison of the next lower dose to placebo.|Mixed effect repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R2.5 minus Placebo||0.135|-0.021|0.1484
71098400|NCT01122680|141704914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.067|STANDARD_ERROR_OF_MEAN|0.036||0.0664||95.0|-0.005|0.138||This test is considered as descriptive.|Mixed effect repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R1.25 minus Placebo||0.138|-0.005|0.0664
71098401|NCT01122680|141704914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.039||||95.0|-0.031|0.124|||Mixed effect repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R5 minus Tio R1.25||0.124|-0.031|
71098402|NCT01122680|141704914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.036||||95.0|-0.014|0.126|||Mixed effect repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R5 minus Tio R2.5||0.126|-0.014|
71098403|NCT01122680|141704914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.04||||95.0|-0.088|0.069|||Mixed effect repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R2.5 minus Tio R1.25||0.069|-0.088|
70987536|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.014||||0.0019|TWO_SIDED|95.0|1.005|1.023|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.023|1.005|0.0019
70987537|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.701||||0.0083|TWO_SIDED|95.0|0.539|0.913|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.913|0.539|0.0083
70987538|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.174|||<|0.0001|TWO_SIDED|95.0|0.09|0.338|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.338|0.090|<0.0001
71098404|NCT01550965|141704928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.4|||<|0.001|TWO_SIDED|95.0|16.08|18.73|||paired t-test, 2 sided|||Hypothesis testing for the first ranked primary outcome was performed in a hierarchical order using the two-sided paired t-test for mean change equal to zero.||18.73|16.08|<0.001
70987539|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.057||||0.0008|TWO_SIDED|95.0|1.023|1.091|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.091|1.023|0.0008
71098405|NCT01550965|141704929|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1383.81|||<|0.001|TWO_SIDED|95.0|-1586.36|-1181.26|||Paired t-test, 2 sided|||Hypothesis testing for the second ranked primary outcome was performed in a hierarchical order using the two-sided paired t-test for mean change equal to zero.||-1181.26|-1586.36|<0.001
71098406|NCT01550965|141704930|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1297.77|||<|0.001|TWO_SIDED|95.0|-1562.17|-1033.36|||Paired t-test, 2 sided|||||-1033.36|-1562.17|<0.001
71098407|NCT01550965|141704931|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4308.32|||<|0.001|TWO_SIDED|95.0|-4985.13|-3631.51|||Paired t-test, 2 sided|||||-3631.51|-4985.13|<0.001
71098408|NCT01550965|141704932|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.3|||<|0.001|TWO_SIDED|95.0|-9.83|-4.78|||Paired t-test, 2 sided|||||-4.78|-9.83|<0.001
71098409|NCT01550965|141704933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.37|||<|0.001|TWO_SIDED|95.0|21.5|27.25|||Paired t-test, 2 sided|||Statistical analysis for Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness.||27.25|21.50|<0.001
71098410|NCT01550965|141704933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.95|||<|0.001|TWO_SIDED|95.0|15.42|22.48|||Paired t-test, 2 sided|||Statistical analysis for Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects.||22.48|15.42|<0.001
70987540|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.638||||0.0255|TWO_SIDED|95.0|0.431|0.946|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.946|0.431|0.0255
70987541|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.755||||0.0059|TWO_SIDED|95.0|0.618|0.922|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.922|0.618|0.0059
70987542|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.521||||0.0005|TWO_SIDED|95.0|1.501|4.236|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||4.236|1.501|0.0005
70987543|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.602||||0.0011|TWO_SIDED|95.0|1.463|4.627|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||4.627|1.463|0.0011
70987544|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.727||||0.0034|TWO_SIDED|95.0|1.198|2.491|||Regression, Logistic|||The statistical analysis is presented for mode of infection (other vs injection drug U). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.491|1.198|0.0034
70987545|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.545||||0.0014|TWO_SIDED|95.0|0.376|0.792|||Regression, Logistic|||The statistical analysis is presented for AST ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.792|0.376|0.0014
70987546|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.0042|TWO_SIDED|95.0|0.822|0.964|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.964|0.822|0.0042
70987547|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.824||||0.0363|TWO_SIDED|95.0|0.687|0.988|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.988|0.687|0.0363
71038267|NCT01243151|141583762|SUPERIORITY_OR_OTHER||LS Mean Difference|-106.06|STANDARD_ERROR_OF_MEAN|8.585|<|0.0001|TWO_SIDED|95.0|-123.34|-88.78|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-88.78|-123.34|<0.0001
71038268|NCT01243151|141583762|SUPERIORITY_OR_OTHER||LS Mean Difference|-99.18|STANDARD_ERROR_OF_MEAN|8.334|<|0.0001|TWO_SIDED|95.0|-115.95|-82.4|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-82.40|-115.95|<0.0001
71038269|NCT01243151|141583762|SUPERIORITY_OR_OTHER||LS Mean Difference|-79.07|STANDARD_ERROR_OF_MEAN|8.557|<|0.0001|TWO_SIDED|95.0|-96.22|-61.93|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-61.93|-96.22|<0.0001
71038270|NCT01243151|141583762|SUPERIORITY_OR_OTHER||LS Mean Difference|-83.89|STANDARD_ERROR_OF_MEAN|8.736|<|0.0001|TWO_SIDED|95.0|-101.4|-66.39|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-66.39|-101.40|<0.0001
71098411|NCT01550965|141704933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2|||<|0.001|TWO_SIDED|95.0|3.89|8.5|||Paired t-test, 2 sided)|||Statistical analysis for Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience.||8.50|3.89|<0.001
71098412|NCT01550965|141704933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.6|||<|0.001|TWO_SIDED|95.0|19.55|25.64|||Paired t-test, 2 sided|||Statistical analysis for Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction.||25.64|19.55|<0.001
71098413|NCT01550965|141704934|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.85|||<|0.001|TWO_SIDED|95.0|-5.42|-4.27|||Paired t-test, 2 sided|||Statistical analysis for overall UC-related outpatient utilization.||-4.27|-5.42|<0.001
71098414|NCT01550965|141704934|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.83|TWO_SIDED|95.0|-0.11|0.09|||Paired t-test, 2 sided|||Statistical analysis for overall UC-related outpatient utilization during emergency department visits.||0.09|-0.11|0.830
71098415|NCT01550965|141704934|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.92|||<|0.001|TWO_SIDED|95.0|-1.18|-0.66|||Paired t-test, 2 sided|||Statistical analysis for overall UC-related outpatient utilization during primary care doctor visits.||-0.66|-1.18|<0.001
71038271|NCT01243151|141583762|SUPERIORITY_OR_OTHER||LS Mean Difference|-104.74|STANDARD_ERROR_OF_MEAN|8.679|<|0.0001|TWO_SIDED|95.0|-122.13|-87.35|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-87.35|-122.13|<0.0001
71098416|NCT01550965|141704935|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||McNemar|||Statistical analysis for percentage of participants with absence of blood in stool from week 0 to week 26.||||<0.001
70987548|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.842||||0.0033|TWO_SIDED|95.0|0.751|0.944|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.944|0.751|0.0033
70987549|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.477||||0.0006|TWO_SIDED|95.0|1.183|1.844|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.844|1.183|0.0006
70987550|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.128||||0.381|TWO_SIDED|95.0|0.862|1.477|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.477|0.862|0.3810
70987551|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.812||||0.0279|TWO_SIDED|95.0|0.674|0.978|||Regression, Logistic|||The statistical analysis is presented for AST ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.978|0.674|0.0279
70987552|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|45.894|||<|0.0001|TWO_SIDED|95.0|27.972|75.299|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (RVR vs no RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||75.299|27.972|<0.0001
70987553|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|32.176|||<|0.0001|TWO_SIDED|95.0|20.129|51.434|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs no RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||51.434|20.129|<0.0001
70987554|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.928|||<|0.0001|TWO_SIDED|95.0|4.291|11.188|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs NO RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||11.188|4.291|<0.0001
70987555|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.733||||0.0204|TWO_SIDED|95.0|0.564|0.953|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.953|0.564|0.0204
70987556|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.17|||<|0.0001|TWO_SIDED|95.0|0.087|0.331|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.331|0.087|<0.0001
70987557|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.806||||0.001|TWO_SIDED|95.0|1.514|5.201|||Regression, Logistic|||The statistical analysis is presented for on-treatment response, combined (RVR vs no RVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||5.201|1.514|0.0010
70987558|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.663||||0.0459|TWO_SIDED|95.0|0.443|0.993|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.993|0.443|0.0459
70987559|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.758||||0.0087|TWO_SIDED|95.0|0.616|0.932|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.932|0.616|0.0087
71038272|NCT01243151|141583762|SUPERIORITY_OR_OTHER||LS Mean Difference|-97.0|STANDARD_ERROR_OF_MEAN|8.426|<|0.0001|TWO_SIDED|95.0|-113.89|-80.11|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-80.11|-113.89|<0.0001
71098417|NCT01550965|141704936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.11|||<|0.001|TWO_SIDED|95.0|10.21|12.02|||Paired t-test, 2 sided|||Statistical analysis for mean change in SIBDQ: Total Score from week 0 to week 2.||12.02|10.21|<0.001
71098418|NCT01550965|141704936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.38|||<|0.001|TWO_SIDED|95.0|14.2|16.56|||Paired t-test, 2 sided|||Statistical analysis for mean change in SIBDQ: Total Score from week 0 to week 8.||16.56|14.20|<0.001
71098419|NCT01550965|141704936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.77|||<|0.001|TWO_SIDED|95.0|13.57|15.96|||Paired t-test, 2 sided|||Statistical analysis for mean change in SIBDQ: Total Score from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF).||15.96|13.57|<0.001
71098420|NCT01550965|141704936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.4|||<|0.001|TWO_SIDED|95.0|16.08|18.73|||Paired t-test, 2 sided|||Statistical analysis for mean change in SIBDQ: Total Score from week 0 to week 26.||18.73|16.08|<0.001
71098421|NCT01550965|141704937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63|||<|0.001|TWO_SIDED|95.0|-0.69|-0.57|||Paired t-test, 2 sided|||Statistical analysis for mean change in PGA from week 0 to week 2.||-0.57|-0.69|<0.001
71098422|NCT01550965|141704937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|||<|0.001|TWO_SIDED|95.0|-1.16|-1.0|||Paired t-test, 2 sided|||Statistical analysis for mean change in PGA from week 0 to week 8.||-1.00|-1.16|<0.001
71098423|NCT01550965|141704937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86|||<|0.001|TWO_SIDED|95.0|-0.95|-0.77|||Paired t-test, 2 sided|||Statistical analysis for mean change in PGA from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using LOCF.||-0.77|-0.95|<0.001
71098424|NCT01550965|141704937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|||<|0.001|TWO_SIDED|95.0|-1.23|-1.06|||Paired t-test, 2 sided|||Statistical analysis for mean change in PGA from week 0 to week 26.||-1.06|-1.23|<0.001
71098425|NCT01550965|141704938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.22|||<|0.001|TWO_SIDED|95.0|-3.46|-2.99|||Paired t-test, 2 sided|||Statistical analysis for mean change in total SCCAI from week 0 to week 2.||-2.99|-3.46|<0.001
71098426|NCT01550965|141704938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.06|||<|0.001|TWO_SIDED|95.0|-4.37|-3.76|||Paired t-test, 2 sided|||Statistical analysis for mean change in total SCCAI from week 0 to week 8.||-3.76|-4.37|<0.001
71098427|NCT01550965|141704938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.01|||<|0.001|TWO_SIDED|95.0|-3.36|-2.66|||Paired t-test, 2 sided|||Statistical analysis for mean change in total SCCAI from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using LOCF.||-2.66|-3.36|<0.001
71098428|NCT01550965|141704938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.07|||<|0.001|TWO_SIDED|95.0|-4.43|-3.72|||Paired t-test, 2 sided|||Statistical analysis for mean change in total SCCAI from week 0 to week 26.||-3.72|-4.43|<0.001
71098429|NCT01550965|141704939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||<|0.001|TWO_SIDED|95.0|0.08|0.11|||Paired t-test, 2 sided|||Statistical analysis for mean change in total EQ-5D-5L total score from week 0 to week 2.||0.11|0.08|<0.001
71098430|NCT01550965|141704939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|||<|0.001|TWO_SIDED|95.0|0.11|0.15|||Paired t-test, 2 sided|||Statistical analysis for mean change in total EQ-5D-5L total score from week 0 to week 8.||0.15|0.11|<0.001
71098431|NCT01550965|141704939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|||<|0.001|TWO_SIDED|95.0|0.1|0.14|||Paired t-test, 2 sided|||Statistical analysis for mean change in total EQ-5D-5L total score from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using LOCF.||0.14|0.10|<0.001
71098432|NCT01550965|141704939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||<|0.001|TWO_SIDED|95.0|0.12|0.17|||Paired t-test, 2 sided|||Statistical analysis for mean change in total EQ-5D-5L total score from week 0 to week 26.||0.17|0.12|<0.001
71098433|NCT01550965|141704940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.62|||<|0.001|TWO_SIDED|95.0|-12.07|-5.18|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of work time missed from week 0 to week 2.||-5.18|-12.07|<0.001
71098434|NCT01550965|141704940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.22|||<|0.001|TWO_SIDED|95.0|-16.27|-8.16|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of work time missed from week 0 to week 8.||-8.16|-16.27|<0.001
71098435|NCT01550965|141704940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.61|||<|0.001|TWO_SIDED|95.0|-15.82|-7.4|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of work time missed from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF).||-7.40|-15.82|<0.001
71098436|NCT01550965|141704940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.43|||<|0.001|TWO_SIDED|95.0|-15.5|-7.35|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of work time missed from week 0 to week 26.||-7.35|-15.50|<0.001
71098437|NCT01550965|141704941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.56|||<|0.001|TWO_SIDED|95.0|-20.0|-13.12|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of impairment while working from week 0 to week 2.||-13.12|-20.00|<0.001
71098438|NCT01550965|141704941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.95|||<|0.001|TWO_SIDED|95.0|-26.93|-18.97|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of impairment while working from week 0 to week 8.||-18.97|-26.93|<0.001
71098439|NCT01550965|141704941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.68|||<|0.001|TWO_SIDED|95.0|-25.69|-17.67|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of impairment while working from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF).||-17.67|-25.69|<0.001
71098440|NCT01550965|141704941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.45|||<|0.001|TWO_SIDED|95.0|-28.33|-20.58|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of impairment while working from week 0 to week 26.||-20.58|-28.33|<0.001
71098441|NCT01550965|141704942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.34|||<|0.001|TWO_SIDED|95.0|-22.1|-14.57|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: overall work impairment percentage from week 0 to week 2.||-14.57|-22.10|<0.001
71098442|NCT01550965|141704942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.54|||<|0.001|TWO_SIDED|95.0|-31.08|-22.0|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: overall work impairment percentage from week 0 to week 8.||-22.00|-31.08|<0.001
70987560|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.054||||0.0064|TWO_SIDED|95.0|1.224|3.447|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.447|1.224|0.0064
70987561|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.931||||0.0271|TWO_SIDED|95.0|1.077|3.461|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missed vs cirrhosis). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.461|1.077|0.0271
70987562|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.738||||0.0039|TWO_SIDED|95.0|1.194|2.528|||Regression, Logistic|||The statistical analysis is presented for mode of infection (other vs injection drug U). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.528|1.194|0.0039
70987563|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.565||||0.0035|TWO_SIDED|95.0|0.386|0.829|||Regression, Logistic|||The statistical analysis is presented for AST ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.829|0.386|0.0035
70987564|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.533||||0.0071|TWO_SIDED|95.0|1.593|19.219|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs no RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||19.219|1.593|0.0071
71038273|NCT01243151|141583763|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.3|STANDARD_ERROR_OF_MEAN|29.336||0.448|TWO_SIDED|95.0|-80.08|35.49|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||35.49|-80.08|0.4480
70987565|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.964||||0.3042|TWO_SIDED|95.0|0.542|7.114|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs no RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||7.114|0.542|0.3042
71038274|NCT01243151|141583763|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.52|STANDARD_ERROR_OF_MEAN|30.091||0.2809|TWO_SIDED|95.0|-91.8|26.76|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||26.76|-91.80|0.2809
71038275|NCT01243151|141583763|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.92|STANDARD_ERROR_OF_MEAN|29.942||0.2875|TWO_SIDED|95.0|-90.9|27.07|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||27.07|-90.90|0.2875
71038276|NCT01243151|141583763|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.52|STANDARD_ERROR_OF_MEAN|29.37||0.5743|TWO_SIDED|95.0|-74.38|41.33|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||41.33|-74.38|0.5743
71098443|NCT01550965|141704942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.33|||<|0.001|TWO_SIDED|95.0|-29.97|-20.7|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: overall work impairment percentage from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using LOCF.||-20.70|-29.97|<0.001
70987566|NCT01070550|141484312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.726||||0.41|TWO_SIDED|95.0|0.471|6.318|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs no RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.318|0.471|0.4100
71038277|NCT01243151|141583763|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.83|STANDARD_ERROR_OF_MEAN|29.336||0.4997|TWO_SIDED|95.0|-77.62|37.96|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||37.96|-77.62|0.4997
71038278|NCT01243151|141583763|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.5|STANDARD_ERROR_OF_MEAN|30.091||0.4756|TWO_SIDED|95.0|-80.78|37.78|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||37.78|-80.78|0.4756
71038279|NCT01243151|141583763|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.73|STANDARD_ERROR_OF_MEAN|30.458||0.561|TWO_SIDED|95.0|-77.73|42.26|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||42.26|-77.73|0.5610
71098444|NCT01550965|141704942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.22|||<|0.001|TWO_SIDED|95.0|-33.5|-24.93|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: overall work impairment percentage from week 0 to week 26.||-24.93|-33.50|<0.001
70987567|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.379|||<|0.0001|TWO_SIDED|95.0|1.236|1.538|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.538|1.236|<0.0001
70987568|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.033||||0.0251|TWO_SIDED|95.0|1.004|1.063|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.063|1.004|0.0251
70987569|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.585|||<|0.0001|TWO_SIDED|95.0|1.358|1.849|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.849|1.358|<0.0001
70987570|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.501||||0.0317|TWO_SIDED|95.0|1.036|2.174|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\<=1 vs \> 3). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.174|1.036|0.0317
70987571|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.493||||0.0129|TWO_SIDED|95.0|1.089|2.048|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\> 1 - 3 vs \> 3). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.048|1.089|0.0129
70987572|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.616||||0.0128|TWO_SIDED|95.0|1.107|2.357|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\^9/L at BL (\< 140 vs \>=180). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.357|1.107|0.0128
70987573|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.046||||0.7809|TWO_SIDED|95.0|0.763|1.432|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\^9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.432|0.763|0.7809
70987574|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.969|||<|0.0001|TWO_SIDED|95.0|0.962|0.976|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.976|0.962|<0.0001
71098445|NCT01550965|141704943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.16|||<|0.001|TWO_SIDED|95.0|-20.47|-15.85|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of activity impairment from week 0 to week 2.||-15.85|-20.47|<0.001
70987575|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.298||||0.0189|TWO_SIDED|95.0|1.273|14.512|||Regression, Logistic|||The statistical analysis is presented for Cumulative PEG-IFN alfa-2a dose per 1000 ug, first 12 weeks. The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||14.512|1.273|0.0189
70987576|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.567||||0.0316|TWO_SIDED|95.0|1.04|2.359|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.359|1.040|0.0316
70987577|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.495||||0.0024|TWO_SIDED|95.0|1.701|11.879|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||11.879|1.701|0.0024
71098446|NCT01550965|141704943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.43|||<|0.001|TWO_SIDED|95.0|-28.3|-22.56|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of activity impairment from week 0 to week 8.||-22.56|-28.30|<0.001
71098447|NCT01550965|141704943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.42|||<|0.001|TWO_SIDED|95.0|-27.33|-21.5|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of activity impairment from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF).||-21.50|-27.33|<0.001
71038280|NCT01243151|141583763|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.41|STANDARD_ERROR_OF_MEAN|29.37||0.4667|TWO_SIDED|95.0|-79.27|36.44|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||36.44|-79.27|0.4667
71098448|NCT01550965|141704943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.22|||<|0.001|TWO_SIDED|95.0|-30.28|-24.16|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of activity impairment from week 0 to week 26.||-24.16|-30.28|<0.001
70987578|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.112||||0.0247|TWO_SIDED|95.0|1.014|1.219|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.219|1.014|0.0247
70987579|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.844||||0.0258|TWO_SIDED|95.0|1.077|3.158|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.158|1.077|0.0258
70987580|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.677||||0.0007|TWO_SIDED|95.0|1.243|2.263|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.263|1.243|0.0007
70987581|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.384||||0.0002|TWO_SIDED|95.0|1.166|1.641|||Regression, Logistic|||The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.641|1.166|0.0002
70987582|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.09||||0.0002|TWO_SIDED|95.0|1.421|3.074|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.074|1.421|0.0002
70987583|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.288||||0.0006|TWO_SIDED|95.0|0.141|0.588|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.588|0.141|0.0006
70987584|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.247||||0.0013|TWO_SIDED|95.0|0.106|0.579|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.579|0.106|0.0013
70987585|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.959||||0.0062|TWO_SIDED|95.0|0.931|0.988|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.988|0.931|0.0062
70987586|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.708||||0.002|TWO_SIDED|95.0|0.568|0.881|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, first 12 weeks. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.881|0.568|0.0020
70987587|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.434|||<|0.0001|TWO_SIDED|95.0|1.288|1.596|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.596|1.288|<0.0001
70987588|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.475|||<|0.0001|TWO_SIDED|95.0|1.26|1.726|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.726|1.260|<0.0001
71098449|NCT03760640|141704944|SUPERIORITY||LS Mean Difference|-0.86||||0.339|TWO_SIDED|90.0|-2.35|0.63|||Mixed Models Analysis|||||0.63|-2.35|0.339
71098450|NCT03760640|141704945|SUPERIORITY||LS Mean Difference|3.0||||0.011|TWO_SIDED|90.0|1.1|4.9|||Mixed Models Analysis|||||4.90|1.10|0.011
71098451|NCT03760640|141704946|SUPERIORITY||LS Mean Difference|0.56||||0.557|TWO_SIDED|90.0|-1.02|2.14|||Mixed Models Analysis|||||2.14|-1.02|0.557
71098452|NCT03760640|141704947|SUPERIORITY||LS Mean Difference|-0.04||||0.548|TWO_SIDED|90.0|-0.15|0.07|||Mixed Models Analysis|||||0.07|-0.15|0.548
71098453|NCT03760640|141704949|SUPERIORITY||LS Mean Difference|0.49||||0.577|TWO_SIDED|90.0|-0.97|1.94|||Mixed Models Analysis|||||1.94|-0.97|0.577
70987589|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.963|||<|0.0001|TWO_SIDED|95.0|0.956|0.97|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.970|0.956|<0.0001
70987590|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.195|||<|0.0001|TWO_SIDED|95.0|1.12|1.275|||Regression, Logistic|||The statistical analysis is presented for cumulative PEG-IFN alfa-2a dose per 1000 ug. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.275|1.120|<0.0001
70987591|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.567||||0.0316|TWO_SIDED|95.0|1.04|2.359|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.359|1.040|0.0316
70987592|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.495||||0.0024|TWO_SIDED|95.0|1.701|11.879|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||11.879|1.701|0.0024
70987593|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.112||||0.0247|TWO_SIDED|95.0|1.014|1.219|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.219|1.014|0.0247
70987594|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.844||||0.0258|TWO_SIDED|95.0|1.077|3.158|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.158|1.077|0.0258
70987595|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.0009|TWO_SIDED|95.0|1.232|2.235|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.235|1.232|0.0009
70987596|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.255||||0.0045|TWO_SIDED|95.0|1.073|1.467|||Regression, Logistic|||The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.467|1.073|0.0045
70987597|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.086||||0.0001|TWO_SIDED|95.0|1.434|3.034|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.034|1.434|0.0001
70987598|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.318||||0.001|TWO_SIDED|95.0|0.16|0.63|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.630|0.160|0.0010
70987599|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.275||||0.0021|TWO_SIDED|95.0|0.121|0.626|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.626|0.121|0.0021
70987600|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.962||||0.0064|TWO_SIDED|95.0|0.935|0.989|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.989|0.935|0.0064
70987601|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.391|||<|0.0001|TWO_SIDED|95.0|1.245|1.553|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.553|1.245|<0.0001
70987602|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.295||||0.0029|TWO_SIDED|95.0|1.092|1.535|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.535|1.092|0.0029
70987603|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.109|||<|0.0001|TWO_SIDED|95.0|0.05|0.236|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (RVR vs no RVR/EVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.236|0.050|<0.0001
71038281|NCT01243151|141583763|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.7|STANDARD_ERROR_OF_MEAN|29.828||0.3045|TWO_SIDED|95.0|-89.45|28.06|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||28.06|-89.45|0.3045
71038282|NCT01243151|141583763|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.78|STANDARD_ERROR_OF_MEAN|30.091||0.4301|TWO_SIDED|95.0|-83.06|35.5|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||35.50|-83.06|0.4301
71038283|NCT01243151|141583763|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.15|STANDARD_ERROR_OF_MEAN|30.458||0.0881|TWO_SIDED|95.0|-112.15|7.85|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||7.85|-112.15|0.0881
70987604|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32||||0.0014|TWO_SIDED|95.0|0.159|0.645|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs no RVR/EVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.645|0.159|0.0014
70987605|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.248||||0.539|TWO_SIDED|95.0|0.616|2.528|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs no RVR/EVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.528|0.616|0.5390
70987606|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.604||||0.0223|TWO_SIDED|95.0|1.069|2.405|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.405|1.069|0.0223
70987607|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.444||||0.0056|TWO_SIDED|95.0|1.547|12.766|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||12.766|1.547|0.0056
70987608|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.403||||0.0267|TWO_SIDED|95.0|1.04|1.892|||Regression, Logistic|||The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.892|1.040|0.0267
70987609|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.226||||0.0018|TWO_SIDED|95.0|0.089|0.575|||Regression, Logistic|||The statistical analysis is presented for on-treatment response, combined (RVR vs no RVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.575|0.089|0.0018
70987610|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.529||||0.0083|TWO_SIDED|95.0|1.116|2.097|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.097|1.116|0.0083
70987611|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.285||||0.0028|TWO_SIDED|95.0|1.09|1.515|||Regression, Logistic|||The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.515|1.090|0.0028
70987612|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.061||||0.0002|TWO_SIDED|95.0|1.401|3.032|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.032|1.401|0.0002
70987613|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.327||||0.0019|TWO_SIDED|95.0|0.162|0.662|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.662|0.162|0.0019
70987614|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32||||0.0086|TWO_SIDED|95.0|0.137|0.749|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missed vs cirrhosis). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.749|0.137|0.0086
70987615|NCT01070550|141484328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.247|||<|0.0001|TWO_SIDED|95.0|0.138|0.441|||Regression, Logistic|||The statistical analysis is presented for on-treatment response, combined (RVR vs NO RVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.441|0.138|<0.0001
70987616|NCT04964063|141484333|OTHER||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-1.47|-1.19|||ANOVA||Q1: How intense are the sensation|||-1.19|-1.47|<.0001
70987617|NCT04964063|141484333|OTHER||Mean Difference (Final Values)|-1.61|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.77|-1.45|||ANOVA||Q2: How bothered are you by any sensation|||-1.45|-1.77|<.0001
70987618|NCT04964063|141484333|OTHER||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.33|-1.0|||ANOVA||Q3: How well can you tolerate sensations|||-1.00|-1.33|<.0001
70987619|NCT04964063|141484334|OTHER||Median Difference (Final Values)|-1.84|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-1.98|-1.7|||ANOVA||Q1: How intense are the sensation|||-1.70|-1.98|<.0001
70987620|NCT04964063|141484334|OTHER||Mean Difference (Final Values)|-2.17|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-2.33|-2.02|||ANOVA||Q2: How bothered are you by any sensation|||-2.02|-2.33|<.0001
70987621|NCT04964063|141484334|OTHER||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.61|-1.29|||ANOVA||Q3: How well can you tolerate sensations|||-1.29|-1.61|<.0001
70987622|NCT04964063|141484335|OTHER||Mean Difference (Final Values)|-2.29|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-2.43|-2.15|||ANOVA||Q1: How intense are the sensation|||-2.15|-2.43|<.0001
70987623|NCT04964063|141484335|OTHER||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-2.79|-2.47|||ANOVA||Q2: How bothered are you by any sensation|||-2.47|-2.79|<.0001
70987624|NCT04964063|141484335|OTHER||Mean Difference (Final Values)|-1.86|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-2.02|-1.7|||ANOVA||Q3: How well can you tolerate sensations|||-1.70|-2.02|<.0001
70987625|NCT04964063|141484336|OTHER||Mean Difference (Final Values)|-2.54|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-2.68|-2.4|||ANOVA||Q1: How intense are the sensation|||-2.40|-2.68|<.0001
70987626|NCT04964063|141484336|OTHER||Mean Difference (Final Values)|-2.89|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-3.05|-2.73|||ANOVA||Q2: How bothered are you by any sensation|||-2.73|-3.05|<.0001
70987627|NCT04964063|141484336|OTHER||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-2.2|-1.87|||ANOVA||Q3: How well can you tolerate sensations|||-1.87|-2.20|<.0001
70987628|NCT04964063|141484337|OTHER||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-2.84|-2.55|||ANOVA||Q1: How intense are the sensation|||-2.55|-2.84|<.0001
70987629|NCT04964063|141484337|OTHER||Mean Difference (Final Values)|-2.99|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-3.15|-2.83|||ANOVA||Q2: How bothered are you by any sensation|||-2.83|-3.15|<.0001
70987630|NCT04964063|141484337|OTHER||Mean Difference (Final Values)|-2.18|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-2.35|-2.02|||ANOVA||Q3: How well can you tolerate sensations|||-2.02|-2.35|<.0001
71098454|NCT03016403|141704950|SUPERIORITY||Mean Difference (Final Values)|1.75||||0.0057|TWO_SIDED|95.0|0.52|2.98||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||2.98|0.52|0.0057
70987631|NCT04964063|141484338|OTHER||Median Difference (Final Values)|-2.94|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-3.08|-2.79|||ANOVA||Q1: How intense are the sensation|||-2.79|-3.08|<.0001
70987632|NCT04964063|141484338|OTHER||Median Difference (Final Values)|-3.24|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-3.4|-3.08|||ANOVA||Q2: How bothered are you by any sensation|||-3.08|-3.40|<.0001
70987633|NCT04964063|141484338|OTHER||Mean Difference (Final Values)|-2.37|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-2.53|-2.21|||ANOVA||Q3: How well can you tolerate sensations|||-2.21|-2.53|<.0001
70987634|NCT04964063|141484340|OTHER||Mean Difference (Final Values)|-17.93|STANDARD_ERROR_OF_MEAN|1.91|<|0.0001|TWO_SIDED|95.0|-20.81|-15.05|||ANOVA|||||-15.05|-20.81|<.0001
70987635|NCT04964063|141484341|OTHER||Mean Difference (Final Values)|-31.2|STANDARD_ERROR_OF_MEAN|1.9|<|0.0001|TWO_SIDED|95.0|-34.04|-28.36|||ANOVA|||||-28.36|-34.04|<.0001
70987636|NCT04964063|141484342|OTHER||Mean Difference (Final Values)|-39.45|STANDARD_ERROR_OF_MEAN|1.9|<|0.0001|TWO_SIDED|95.0|-42.3|-36.59|||ANOVA|||||-36.59|-42.30|<.0001
70987637|NCT04964063|141484343|OTHER||Mean Difference (Final Values)|-44.37|STANDARD_ERROR_OF_MEAN|1.91|<|0.0001|TWO_SIDED|95.0|-47.24|-41.49|||ANOVA|||||-41.49|-47.24|<.0001
70987638|NCT04964063|141484344|OTHER||Mean Difference (Final Values)|-48.04|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED|95.0|-50.96|-45.12|||ANOVA|||||-45.12|-50.96|<.0001
70987639|NCT04964063|141484345|OTHER||Mean Difference (Final Values)|-52.47|STANDARD_ERROR_OF_MEAN|1.91|<|0.0001|TWO_SIDED|95.0|-55.33|-49.62|||ANOVA|||||-49.62|-55.33|<.0001
70987640|NCT04964063|141484347|OTHER||Mean Difference (Final Values)|-2.45|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.88|-2.02|||ANOVA|||||-2.02|-2.88|<.0001
70987641|NCT04964063|141484348|OTHER||Mean Difference (Final Values)|-4.27|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-4.69|-3.85|||ANOVA|||||-3.85|-4.69|<.0001
70987642|NCT04964063|141484349|OTHER||Mean Difference (Final Values)|-5.71|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-6.13|-5.28|||ANOVA|||||-5.28|-6.13|<.0001
70987643|NCT04964063|141484350|OTHER||Mean Difference (Final Values)|-6.45|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-6.88|-6.02|||ANOVA|||||-6.02|-6.88|<.0001
70987644|NCT04964063|141484351|OTHER||Median Difference (Final Values)|-7.01|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-7.45|-6.58|||ANOVA|||||-6.58|-7.45|<.0001
70987645|NCT04964063|141484352|OTHER||Mean Difference (Final Values)|-7.44|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-7.87|-7.01|||ANOVA|||||-7.01|-7.87|<.0001
70987646|NCT04964063|141484354|OTHER||Mean Difference (Final Values)|-6.33|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|-7.46|-5.2|||ANOVA|||||-5.20|-7.46|<.0001
70987647|NCT04964063|141484355|OTHER||Mean Difference (Final Values)|-11.53|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|-12.64|-10.41|||ANOVA|||||-10.41|-12.64|<.0001
70987648|NCT04964063|141484356|OTHER||Mean Difference (Final Values)|-14.54|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|-15.66|-13.42|||ANOVA|||||-13.42|-15.66|<.0001
70987649|NCT04964063|141484357|OTHER||Median Difference (Final Values)|-16.54|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|-17.67|-15.41|||ANOVA|||||-15.41|-17.67|<.0001
70987650|NCT04964063|141484358|OTHER||Mean Difference (Final Values)|-17.73|STANDARD_ERROR_OF_MEAN|0.73|<|0.0001|TWO_SIDED|95.0|-18.87|-16.58|||ANOVA|||||-16.58|-18.87|<.0001
70987651|NCT04964063|141484359|OTHER||Mean Difference (Final Values)|-18.84|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|-19.96|-17.72|||ANOVA|||||-17.72|-19.96|<.0001
70987652|NCT04964063|141484361|OTHER||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-2.52|-1.56|||ANOVA|||||-1.56|-2.52|<.0001
70987653|NCT04964063|141484362|OTHER||Mean Difference (Final Values)|-3.69|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-4.17|-3.22|||ANOVA|||||-3.22|-4.17|<.0001
70987654|NCT04964063|141484363|OTHER||Mean Difference (Final Values)|-4.67|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-5.15|-4.2|||ANOVA|||||-4.20|-5.15|<.0001
70987655|NCT04964063|141484364|OTHER||Mean Difference (Final Values)|-5.24|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-5.72|-4.76|||ANOVA|||||-4.76|-5.72|<.0001
70987656|NCT04964063|141484365|OTHER||Mean Difference (Final Values)|-5.63|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-6.12|-5.14|||ANOVA|||||-5.14|-6.12|<.0001
70987657|NCT04964063|141484366|OTHER||Mean Difference (Final Values)|-6.24|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-6.72|-5.77|||ANOVA|||||-5.77|-6.72|<.0001
70987658|NCT04964063|141484368|OTHER||Mean Difference (Final Values)|-5.25|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-6.06|-4.44|||ANOVA|||||-4.44|-6.06|<.0001
70987659|NCT04964063|141484369|OTHER||Mean Difference (Final Values)|-8.52|STANDARD_ERROR_OF_MEAN|0.47|<|0.0001|TWO_SIDED|95.0|-9.32|-7.72|||ANOVA|||||-7.72|-9.32|<.0001
70987660|NCT04964063|141484370|OTHER||Mean Difference (Final Values)|-10.55|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-11.35|-9.75|||ANOVA|||||-9.75|-11.35|<.0001
71038284|NCT01243151|141583763|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.51|STANDARD_ERROR_OF_MEAN|29.37||0.2844|TWO_SIDED|95.0|-89.36|26.35|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||26.35|-89.36|0.2844
71038285|NCT01243151|141583763|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.56|STANDARD_ERROR_OF_MEAN|29.828||0.3741|TWO_SIDED|95.0|-85.32|32.19|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||32.19|-85.32|0.3741
71038286|NCT01243151|141583763|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.88|STANDARD_ERROR_OF_MEAN|30.091||0.4283|TWO_SIDED|95.0|-83.16|35.4|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||35.40|-83.16|0.4283
71038287|NCT01243151|141583763|SUPERIORITY_OR_OTHER||LS Mean Difference|-56.32|STANDARD_ERROR_OF_MEAN|30.458||0.0657|TWO_SIDED|95.0|-116.31|3.68|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||3.68|-116.31|0.0657
71038288|NCT01243151|141583763|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.26|STANDARD_ERROR_OF_MEAN|29.37||0.2586|TWO_SIDED|95.0|-91.11|24.6|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||24.60|-91.11|0.2586
70987661|NCT04964063|141484371|OTHER||Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-12.41|-10.79|||ANOVA|||||-10.79|-12.41|<.0001
70987662|NCT04964063|141484372|OTHER||Mean Difference (Final Values)|-12.63|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-13.45|-11.81|||ANOVA|||||-11.81|-13.45|<.0001
70987663|NCT04964063|141484373|OTHER||Mean Difference (Final Values)|-13.88|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-14.69|-13.08|||ANOVA|||||-13.08|-14.69|<.0001
70987664|NCT04964063|141484375|OTHER||Mean Difference (Final Values)|-1.88|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.43|-1.33|||ANOVA|||||-1.33|-2.43|<.0001
70987665|NCT04964063|141484376|OTHER||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-3.74|-2.65|||ANOVA|||||-2.65|-3.74|<.0001
70987666|NCT04964063|141484377|OTHER||Mean Difference (Final Values)|-3.98|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-4.53|-3.44|||ANOVA|||||-3.44|-4.53|<.0001
70987667|NCT04964063|141484378|OTHER||Mean Difference (Final Values)|-4.55|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-5.1|-4.0|||ANOVA|||||-4.00|-5.10|<.0001
70987668|NCT04964063|141484379|OTHER||Median Difference (Final Values)|-5.04|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-5.6|-4.48|||ANOVA|||||-4.48|-5.60|<.0001
70987669|NCT04964063|141484380|OTHER||Mean Difference (Final Values)|-6.07|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-6.62|-5.53|||ANOVA|||||-5.53|-6.62|<.0001
70987670|NCT04964063|141484382|OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.1091|TWO_SIDED|95.0|-0.12|0.01|||ANOVA|||||0.01|-0.12|0.1091
70987671|NCT04964063|141484383|OTHER||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.19|-0.06|||ANOVA|||||-0.06|-0.19|<.0001
70987672|NCT04964063|141484384|OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.23|-0.1|||ANOVA|||||-0.10|-0.23|<.0001
70987673|NCT04964063|141484385|OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.24|-0.11|||ANOVA|||||-0.11|-0.24|<.0001
70987674|NCT04964063|141484386|OTHER||Median Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.26|-0.13|||ANOVA|||||-0.13|-0.26|<.0001
70987675|NCT04964063|141484387|OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.31|-0.18|||ANOVA|||||-0.18|-0.31|<.0001
70987676|NCT04964063|141484389|OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.95|-1.45|||ANOVA|||||-1.45|-1.95|<.0001
70987677|NCT04964063|141484390|OTHER||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-2.94|-2.44|||ANOVA|||||-2.44|-2.94|<.0001
70987678|NCT04964063|141484391|OTHER||Mean Difference (Final Values)|-3.09|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-3.35|-2.84|||ANOVA|||||-2.84|-3.35|<.0001
70987679|NCT04964063|141484392|OTHER||Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-3.69|-3.19|||ANOVA|||||-3.19|-3.69|<.0001
70987680|NCT04964063|141484393|OTHER||Median Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-4.06|-3.55|||ANOVA|||||-3.55|-4.06|<.0001
70987681|NCT04964063|141484394|OTHER||Mean Difference (Final Values)|-4.26|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-4.51|-4.0|||ANOVA|||||-4.00|-4.51|<.0001
70987682|NCT03350750|141484395|SUPERIORITY||ANCOVA Model Effect (Open vs. Closed)|0.22||||0.071|TWO_SIDED|95.0|-0.02|0.46|||ANCOVA||This is the coefficient for an indicator variable comparing the Open versus Closed shunt group, in a linear regression model with Month 4 gait velocity as the outcome and Baseline gait velocity included as a predictor along with treatment.|||0.46|-0.02|0.071
70987683|NCT03350750|141484396|SUPERIORITY|||||||0.337|||||||ANCOVA|||||||0.337
70987684|NCT03350750|141484397|SUPERIORITY|||||||0.007|||||||ANCOVA|||||||0.007
70987685|NCT03350750|141484398|SUPERIORITY|||||||0.201|||||||ANCOVA|||||||0.201
70987686|NCT03350750|141484399|SUPERIORITY|||||||0.172|||||||ANCOVA|||||||0.172
70987687|NCT03350750|141484400|SUPERIORITY|||||||0.78|||||||ANCOVA|||||||0.780
70987688|NCT03350750|141484401|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70987689|NCT03350750|141484402|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.240
70987690|NCT03350750|141484403|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||||||0.013
70987691|NCT03350750|141484404|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||||||0.019
70987692|NCT03350750|141484405|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.040
70987693|NCT03350750|141484406|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||||||0.013
70987694|NCT03350750|141484407|SUPERIORITY|||||||0.235|||||||Fisher Exact|Fisher's exact test with a mid-p-value correction||||||0.235
70987695|NCT01849250|141484410|SUPERIORITY|||||||0.5|||||||ANCOVA|||||||.50
70987696|NCT01849250|141484413|SUPERIORITY|||||||0.19|||||||ANCOVA|||||||.19
70987697|NCT01849250|141484414|SUPERIORITY|||||||0.52|||||||ANOVA|||||||.52
70987698|NCT01849250|141484415|SUPERIORITY|||||||0.12|||||||ANCOVA|||||||.12
70987699|NCT01525849|141484443|NON_INFERIORITY_OR_EQUIVALENCE|Significance level=0.025 (1-sided alpha), power=90%, delta=0.8, true difference=0, SD for both arms=1.0. A total sample size of 72 participants (36 per arm) was required to test the hypothesis.|||||<|0.001|||||||t-test, 1 sided|||Non-inferiority test to demonstrate that the long-term (1-year) change in sinus symptoms (overall SNOT-20 score) after balloon dilation is not worse than after FESS.||||<0.001
70987700|NCT01525849|141484444|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 1 sided|||Test for superiority of balloon dilation over FESS. Significance level=0.025 (1-sided alpha), power=90%, BD estimate=0.5, FESS estimate=1.5, SD for both arms=1.0. A total sample size of 46 participants (23 per arm) was required to test the hypothesis.||||<0.0001
70987701|NCT01525849|141484445|SUPERIORITY_OR_OTHER|||||||0.628|||||||t-test, 2 sided|||||||0.628
70987702|NCT01525849|141484447|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70987703|NCT00339183|141484448|SUPERIORITY_OR_OTHER_LEGACY||Normal score|-2.91||||0.0036|||||||Stratified log-rank test|P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure, and prior oxaliplatin exposure (yes or no).|A normal score \<0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer progression-free survival time.|An overall 5% significance level was used to compare treatments with respect to both overall survival (OS) and PFS. A 4% and 1% level (2-sided) was used to independently test OS and PFS, respectively.||||0.0036
70987704|NCT00339183|141484448|SUPERIORITY_OR_OTHER_LEGACY||Normal score|-1.46||||0.1448|||||||Stratified log-rank test|P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure and prior oxaliplatin exposure (yes or no).|A normal score \<0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer progression-free survival time.|PFS in the Mutant Efficacy Analysis Set was compared at a 1% level conditional upon first demonstrating a significant difference in PFS in the Wild-type KRAS Efficacy Analysis Set.||||0.1448
70987705|NCT00339183|141484449|SUPERIORITY_OR_OTHER_LEGACY||Normal score|-1.57||||0.1154|||||||Stratified log-rank test|P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure, and prior oxaliplatin exposure (yes or no).|A normal score \<0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer overall survival time.|An overall 5% significance level was used to compare treatments with respect to both overall survival (OS) and PFS. A 4% and 1% level (2-sided) was used to independently test OS and PFS, respectively.||||0.1154
70987706|NCT00339183|141484449|SUPERIORITY_OR_OTHER_LEGACY||Normal score|-0.6||||0.5503|||||||Stratified log-rank test|P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure, and prior oxaliplatin exposure (yes or no).|A normal score \<0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer overall survival time.|The treatment effect on OS in the Mutant KRAS Efficacy Analysis Set was compared at the 4% level conditional on first demonstrating a significant OS treatment effect in the Wild-type KRAS Efficacy Analysis Set.||||0.5503
70987707|NCT00339183|141484450|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.33|||<|0.0001|TWO_SIDED|95.0|3.21|8.6|||Stratified exact test|Adjusted for ECOG score, prior bevacizumab exposure, prior oxaliplatin exposure.|The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFIRI alone arm.|||8.60|3.21|<0.0001
70987708|NCT00339183|141484450|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.56|1.76|||Stratified exact test|Adjusted for ECOG score, prior bevacizumab exposure, prior oxaliplatin exposure.|The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFIRI alone arm.|||1.76|0.56|1.0000
70987709|NCT00477451|141484467|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.200
70987710|NCT00477451|141484468|SUPERIORITY|||||||0.368|||||||Wilcoxon (Mann-Whitney)|||||||0.368
70987711|NCT00477451|141484469|SUPERIORITY|||||||0.207|||||||t-test, 2 sided|||||||0.207
70987712|NCT01757704|141484472|SUPERIORITY_OR_OTHER||Median Difference (Net)|56.0|||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.01
70987713|NCT02144220|141484496|SUPERIORITY_OR_OTHER|||||||0.39|||||||t-test, 2 sided|||||||0.39
70987714|NCT02650284|141484528|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.46||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||Comparison between groups at pre-operation timepoint.||||0.46
70987715|NCT02650284|141484528|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.23||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||Comparison between groups at 6-week timepoint.||||0.23
70987716|NCT02650284|141484528|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.1||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||Comparison between groups at 3-month timepoint.||||0.10
70987717|NCT02650284|141484528|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.98||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||Comparison between groups at 12-month timepoint.||||0.98
70987718|NCT02650284|141484528|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.5||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||Comparison between groups at 24-month timepoint.||||0.50
70987719|NCT02650284|141484529|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.59||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D Index preoperatively between both groups.||||0.59
70987720|NCT02650284|141484529|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.9||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D index at 3-months between both groups.||||0.90
70987721|NCT02650284|141484529|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.57||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D index at 12-months between both groups.||||0.57
70987722|NCT02650284|141484529|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.49||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D index at 24-months between both groups.||||0.49
70987723|NCT02650284|141484529|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means||||||0.65||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D VAS preoperatively between both groups.||||0.65
70987724|NCT02650284|141484529|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.3||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D VAS at 3-months between both groups.||||0.30
70987725|NCT02650284|141484529|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.06||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D VAS at 12-months between both groups.||||0.06
70987726|NCT02650284|141484529|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.44||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D VAS at 24-months between both groups.||||0.44
70987727|NCT02650284|141484530|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.97||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Rest preoperatively between both groups.||||0.97
70987728|NCT02650284|141484530|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.45||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Rest at 3-months between both groups.||||0.45
70987729|NCT02650284|141484530|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.64||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Rest at 12-months between both groups.||||0.64
70987730|NCT02650284|141484530|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.19||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Rest at 24-months between both groups.||||0.19
70987731|NCT02650284|141484530|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.57||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Mobilisation preoperatively between both groups.||||0.57
70987732|NCT02650284|141484530|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.98||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Mobilisation at 3-months between both groups.||||0.98
70987733|NCT02650284|141484530|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.58||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Mobilisation at 12-months between both groups.||||0.58
70987734|NCT02650284|141484530|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.16||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Mobilisation at 24-months between both groups.||||0.16
70987735|NCT02650284|141484531|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.62||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare New Knee Society Function Score preoperatively between both groups.||||0.62
70987736|NCT02650284|141484531|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.06||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare New Knee Society Function Score at 3-months between both groups.||||0.06
70987737|NCT02650284|141484531|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.93||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare New Knee Society Function Score at 24-months between both groups.||||0.93
70987738|NCT02650284|141484532|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.57||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||Comparison between groups at pre-operation timepoint.||||0.57
71038289|NCT01243151|141583764|SUPERIORITY_OR_OTHER||LS Mean Difference|3.33|STANDARD_ERROR_OF_MEAN|3.404||0.3326|TWO_SIDED|95.0|-3.49|10.14|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||10.14|-3.49|0.3326
70987739|NCT02650284|141484532|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.17||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare FJS at 3-months between both groups.||||0.17
70987740|NCT02650284|141484532|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.8||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare FJS at 12-months between both groups.||||0.80
71038290|NCT01243151|141583764|SUPERIORITY_OR_OTHER||LS Mean Difference|3.69|STANDARD_ERROR_OF_MEAN|3.502||0.2967|TWO_SIDED|95.0|-3.32|10.7|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||10.70|-3.32|0.2967
70987741|NCT02650284|141484532|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.9||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare FJS at 24-months between both groups.||||0.90
70987742|NCT02650284|141484534|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.81||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare length of hospital stay (number of nights) between both groups.||||0.81
70987743|NCT00554294|141484540|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69|||<|0.05||95.0|0.48|0.98|||Regression, Logistic|The Odds Ratio (OR) describes the probability ob beeing overweight of the intervention group compared to the control group (reference, denominator).||adjusted for overweight at baseline, age at baseline,sex and clustering by school||0.98|0.48|<0.05
70987744|NCT00337467|141484591|SUPERIORITY_OR_OTHER||Percentage of Participants|21.3|||||TWO_SIDED|95.0|11.9|33.7|||exact binomial methods|Given the small sample size, the 95% confidence interval is made with exact binomial methods.||||33.7|11.9|
70987745|NCT00337467|141484592|SUPERIORITY_OR_OTHER||Percentage of Participants|34.4|||||TWO_SIDED|95.0|22.7|47.7|||exact binomial methods|Given the small sample size, the 95% confidence interval is made with exact binomial methods.||||47.7|22.7|
70987746|NCT00337467|141484597|SUPERIORITY_OR_OTHER||Mean Change (Final Values)|61.0|STANDARD_ERROR_OF_MEAN|24.3|||TWO_SIDED|95.0|12.3|109.8|||normal approximation for 95% CI|||||109.8|12.3|
70987747|NCT00337467|141484598|SUPERIORITY_OR_OTHER||Mean Change (Final Values)|53.0|STANDARD_ERROR_OF_MEAN|30.0|||TWO_SIDED|95.0|-7.1|113.7|||normal approximation for 95% CI|||||113.7|-7.1|
70987748|NCT00337467|141484599|SUPERIORITY_OR_OTHER||Mean Change (Final Values)|63.0|STANDARD_ERROR_OF_MEAN|32.9|||TWO_SIDED|95.0|-4.0|129.1|||normal approximation for 95% CI|||||129.1|-4.0|
70987749|NCT00337467|141484601|SUPERIORITY_OR_OTHER||Mean Change|9.0|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|2.5|14.6|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting Total Cholesterol at Week 48||14.6|2.5|
70987750|NCT00337467|141484601|SUPERIORITY_OR_OTHER||Mean Change|2.0|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-3.9|8.8|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting HDL Cholesterol at Week 48||8.8|-3.9|
70987751|NCT00337467|141484601|SUPERIORITY_OR_OTHER||Mean Change|12.0|STANDARD_ERROR_OF_MEAN|4.1|||TWO_SIDED|95.0|4.0|20.8|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting Non-HDL Cholesterol at Week 48||20.8|4.0|
70987752|NCT00337467|141484601|SUPERIORITY_OR_OTHER||Mean Change|20.0|STANDARD_ERROR_OF_MEAN|5.8|||TWO_SIDED|95.0|8.0|31.7|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting LDL Cholesterol at Week 48||31.7|8.0|
70987753|NCT00337467|141484601|SUPERIORITY_OR_OTHER||Mean Change|17.0|STANDARD_ERROR_OF_MEAN|8.6|||TWO_SIDED|95.0|-0.4|34.4|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting Triglycerides at Week 48||34.4|-0.4|
70987754|NCT00337467|141484602|SUPERIORITY_OR_OTHER||Mean Change|14.0|STANDARD_ERROR_OF_MEAN|3.2||||95.0|6.9|20.1|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting Total Cholesterol at Week 96||20.1|6.9|
70987755|NCT00337467|141484602|SUPERIORITY_OR_OTHER||Mean Change|2.0|STANDARD_ERROR_OF_MEAN|3.9|||TWO_SIDED|95.0|-6.0|10.2|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting HDL Cholesterol at Week 96||10.2|-6.0|
70987756|NCT00337467|141484602|SUPERIORITY_OR_OTHER||Mean Change|19.0|STANDARD_ERROR_OF_MEAN|4.4|||TWO_SIDED|95.0|10.3|28.4|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting Non-HDL Cholesterol at Week 96||28.4|10.3|
70987757|NCT00337467|141484602|SUPERIORITY_OR_OTHER||Mean Change|29.0|STANDARD_ERROR_OF_MEAN|6.5|||TWO_SIDED|95.0|15.3|42.0|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting LDL Cholesterol at Week 96||42.0|15.3|
70987758|NCT00337467|141484602|SUPERIORITY_OR_OTHER||Mean Change|16.0|STANDARD_ERROR_OF_MEAN|12.5|||TWO_SIDED|95.0|-9.5|41.6|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting Triglycerides at Week 96||41.6|-9.5|
70987759|NCT04083222|141484613|SUPERIORITY||||||<|0.001||||||P-value was analyzed using Analysis of Variance (ANOVA) with treatment and screening angiotensin-converting enzyme inhibitor/ angiotensin receptor blockers (ACEi/ARB) dose status stratification factor.|ANOVA|||||||< 0.001
70987760|NCT04083222|141484614|SUPERIORITY|||||||0.399||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 3||||0.399
70987761|NCT04083222|141484614|SUPERIORITY|||||||0.338||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 8||||0.338
70987762|NCT04083222|141484614|SUPERIORITY|||||||0.207||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 15||||0.207
70987763|NCT04083222|141484614|SUPERIORITY|||||||0.927||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 22||||0.927
70987764|NCT04083222|141484614|SUPERIORITY|||||||0.146||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 29||||0.146
70987765|NCT04083222|141484614|SUPERIORITY|||||||0.055||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 36||||0.055
70987766|NCT04083222|141484614|SUPERIORITY|||||||0.095||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 43||||0.095
71038291|NCT01243151|141583764|SUPERIORITY_OR_OTHER||LS Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|3.466||0.8812|TWO_SIDED|95.0|-6.42|7.46|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||7.46|-6.42|0.8812
70987767|NCT04083222|141484614|SUPERIORITY|||||||0.046||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 50||||0.046
70987768|NCT04083222|141484614|SUPERIORITY|||||||0.246||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 57||||0.246
70987769|NCT04083222|141484614|SUPERIORITY|||||||0.17||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 64||||0.170
70987770|NCT04083222|141484614|SUPERIORITY|||||||0.527||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 78||||0.527
70987771|NCT04083222|141484614|SUPERIORITY|||||||0.167||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 92||||0.167
70987772|NCT04083222|141484614|SUPERIORITY|||||||0.266||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 120||||0.266
70987773|NCT04083222|141484614|SUPERIORITY|||||||0.078||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 141||||0.078
70987774|NCT04083222|141484615|SUPERIORITY|||||||0.661||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 3||||0.661
70987775|NCT04083222|141484615|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 8||||<0.001
70987776|NCT04083222|141484615|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 15||||<0.001
70987777|NCT04083222|141484615|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 22||||<0.001
70987778|NCT04083222|141484615|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 29||||<0.001
70987779|NCT04083222|141484615|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 36||||<0.001
70987780|NCT04083222|141484615|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 43||||<0.001
70987781|NCT04083222|141484615|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 50||||<0.001
70987782|NCT04083222|141484615|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 57||||<0.001
70987783|NCT04083222|141484615|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 64||||<0.001
70987784|NCT04083222|141484615|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 78||||<0.001
70987785|NCT04083222|141484615|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 92||||<0.001
70987786|NCT04083222|141484615|SUPERIORITY|||||||0.106||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 120||||0.106
70987787|NCT04083222|141484615|SUPERIORITY|||||||0.318||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 141||||0.318
70987788|NCT04083222|141484616|SUPERIORITY|||||||0.609||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 3||||0.609
70987789|NCT04083222|141484616|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 8||||<0.001
70987790|NCT04083222|141484616|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 15||||<0.001
70987791|NCT04083222|141484616|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 22||||<0.001
70987792|NCT04083222|141484616|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 29||||<0.001
70987793|NCT04083222|141484616|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 36||||<0.001
70987794|NCT04083222|141484616|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 43||||<0.001
71038292|NCT01243151|141583764|SUPERIORITY_OR_OTHER||LS Mean Difference|3.42|STANDARD_ERROR_OF_MEAN|3.433||0.3227|TWO_SIDED|95.0|-3.45|10.3|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||10.30|-3.45|0.3227
71038293|NCT01243151|141583764|SUPERIORITY_OR_OTHER||LS Mean Difference|10.01|STANDARD_ERROR_OF_MEAN|4.221||0.021|TWO_SIDED|95.0|1.56|18.46|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||18.46|1.56|0.0210
71038294|NCT01243151|141583764|SUPERIORITY_OR_OTHER||LS Mean Difference|6.84|STANDARD_ERROR_OF_MEAN|4.326||0.1192|TWO_SIDED|95.0|-1.82|15.49|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||15.49|-1.82|0.1192
70987795|NCT04083222|141484616|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 50||||<0.001
70987796|NCT04083222|141484616|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 64||||<0.001
70987797|NCT04083222|141484616|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 78||||<0.001
70987798|NCT04083222|141484616|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 92||||<0.001
70987799|NCT04083222|141484616|SUPERIORITY|||||||0.112||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 120||||0.112
70987800|NCT04083222|141484616|SUPERIORITY|||||||0.371||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 141||||0.371
70987801|NCT03103750|141484618|SUPERIORITY|||||||0.016|||||||Mixed Models Analysis|||The primary hypothesis of calcitriol-related differences in amphetamine-induced dopamine release was determined by significance of the main effect of medication (calcitriol vs. placebo) on %change in BPND (i.e., post-Amp relative to pre-Amp scans) at a threshold of p\<0.05.||||0.016
70987802|NCT03103750|141484620|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
70987803|NCT01128972|141484621|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.66|||<|0.0001|TWO_SIDED|95.0|7.09|16.24||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and test dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||16.24|7.09|<0.0001
70987804|NCT01128972|141484621|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|26.6|||<|0.0001|TWO_SIDED|95.0|22.02|31.18||No adjustments made for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and reference dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||31.18|22.02|<0.0001
70987805|NCT01128972|141484621|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|37.17|||<|0.0001|TWO_SIDED|95.0|32.59|41.74||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and placebo dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||41.74|32.59|<0.0001
70987806|NCT01128972|141484622|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.11||||0.0083|TWO_SIDED|95.0|1.07|7.15||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and test dentifrice + Sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||7.15|1.07|0.0083
70987807|NCT01128972|141484622|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|11.25|||<|0.0001|TWO_SIDED|95.0|8.22|14.29||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect)|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and reference dentifrice + Sterile water rinse treatment regimen to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||14.29|8.22|<0.0001
71038295|NCT01243151|141583764|SUPERIORITY_OR_OTHER||LS Mean Difference|5.04|STANDARD_ERROR_OF_MEAN|4.367||0.2529|TWO_SIDED|95.0|-3.69|13.78|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||13.78|-3.69|0.2529
70987808|NCT01128972|141484622|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.56|||<|0.0001|TWO_SIDED|95.0|8.53|14.6||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect)|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and placebo dentifrice + Sterile water rinse treatment regimen to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||14.60|8.53|<0.0001
70987809|NCT01128972|141484623|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.88||||0.7041|TWO_SIDED|95.0|-5.46|3.69||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Placebo Dentifrice + Test MR and Test dentifrice+ Test MR treatment regimen treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||3.69|-5.46|0.7041
70987810|NCT01128972|141484623|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.78|||<|0.0001|TWO_SIDED|95.0|6.21|15.36||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Placebo dentifrice+ test MR treatment regimen and test dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||15.36|6.21|<0.0001
70987811|NCT01128972|141484623|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|25.72|||<|0.0001|TWO_SIDED|95.0|21.14|30.29||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the Placebo dentifrice+ Test MR treatment regimen and Reference dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||30.29|21.14|<0.0001
70987812|NCT01128972|141484623|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|36.29|||<|0.0001|TWO_SIDED|95.0|31.71|40.86||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Placebo dentifrice+ test MR treatment regimen and Placebo dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||40.86|31.71|<0.0001
70987813|NCT01128972|141484624|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.39||||0.0049|TWO_SIDED|95.0|-7.43|-1.35||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis considered population means for the Placebo dentifrice+ Test MR treatment regimen and Test dentifrice + Test MR to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||-1.35|-7.43|0.0049
71038296|NCT01243151|141583764|SUPERIORITY_OR_OTHER||LS Mean Difference|7.76|STANDARD_ERROR_OF_MEAN|4.244||0.0725|TWO_SIDED|95.0|-0.73|16.25|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||16.25|-0.73|0.0725
71038297|NCT01243151|141583764|SUPERIORITY_OR_OTHER||LS Mean Difference|6.74|STANDARD_ERROR_OF_MEAN|3.214||0.0405|TWO_SIDED|95.0|0.3|13.18|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||13.18|0.30|0.0405
71038298|NCT01243151|141583764|SUPERIORITY_OR_OTHER||LS Mean Difference|6.27|STANDARD_ERROR_OF_MEAN|3.258||0.0593|TWO_SIDED|95.0|-0.25|12.8|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||12.80|-0.25|0.0593
71098455|NCT03016403|141704951|SUPERIORITY||Mean Difference (Final Values)|1.46||||0.0243|TWO_SIDED|95.0|0.19|2.73||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|Linear mixed models (LMM) have been used with time and the interaction between time and group as fixed effects. A structure of random effects that includes random intercepts for patients was used. The study was powered for testing the hypothesis of no group differences in change over the four time points. A significant group by time interaction was hypothesized.||2.73|0.19|0.0243
70987814|NCT01128972|141484624|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.28||||0.8571|TWO_SIDED|95.0|-3.31|2.76||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the Placebo dentifrice+ test MR treatment regimen and test dentifrice + sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||2.76|-3.31|0.8571
70987815|NCT01128972|141484624|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.87|||<|0.0001|TWO_SIDED|95.0|3.83|9.9||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Placebo Dentifrice + Test MR treatment regimen and Reference Dentifrice + Sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||9.90|3.83|<0.0001
70987816|NCT01128972|141484624|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.17|||<|0.0001|TWO_SIDED|95.0|4.14|10.21||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the Placebo Dentifrice + Test MR treatment regimen and Placebo dentifrice + Sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||10.21|4.14|<0.0001
70987817|NCT01128972|141484625|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|14.94|||||TWO_SIDED|95.0|10.36|19.51||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Test Dentifrice + Sterile water rinse treatment regimen andReference Dentifrice + Sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||19.51|10.36|
70987818|NCT01128972|141484626|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.14|||<|0.0001|TWO_SIDED|95.0|4.11|10.18||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Test Dentifrice + Sterile water rinse treatment regimen and Reference Dentifrice + Sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||10.18|4.11|<0.0001
70987819|NCT02429427|141484629|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.751|TWO_SIDED|95.0|0.8|1.17|||Log Rank|Analysis stratified by oestrogen receptor status and country.|Analysis stratified by oestrogen receptor status and country.|||1.17|0.80|0.751
70987820|NCT02429427|141484630|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.781|TWO_SIDED|95.0|0.76|1.22|||Log Rank|Analysis is stratified for oestrogen receptor status and country.|Analysis is stratified for oestrogen receptor status and country.|||1.22|0.76|0.781
70987821|NCT02078713|141484633|SUPERIORITY||Odds Ratio (OR)|0.89||||0.46|TWO_SIDED|95.0|0.65|1.22||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 7 months post-enrollment||1.22|0.65|0.46
70987822|NCT02078713|141484633|SUPERIORITY||Odds Ratio (OR)|0.79||||0.16|TWO_SIDED|95.0|0.57|1.1||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 4 months post-enrollment||1.10|0.57|0.16
70987823|NCT02078713|141484634|SUPERIORITY||Odds Ratio (OR)|1.45||||0.03|TWO_SIDED|95.0|1.03|2.05||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||2.05|1.03|0.03
70987824|NCT02078713|141484635|SUPERIORITY||Odds Ratio (OR)|1.61||||0.01|TWO_SIDED|95.0|1.11|2.33||P-value calculated in imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||2.33|1.11|0.01
70987825|NCT02078713|141484636|SUPERIORITY||Odds Ratio (OR)|1.11||||0.62|TWO_SIDED|95.0|0.74|1.67||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||1.67|0.74|0.62
70987826|NCT02078713|141484637|SUPERIORITY||Relative risk ratio|1.1||||0.85|TWO_SIDED|95.0|0.4|3.04||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of patients who wished provider had been less involved to right amount (ref)||3.04|0.40|0.85
70987827|NCT02078713|141484637|SUPERIORITY||Relative risk ratio|1.6||||0.24|TWO_SIDED|95.0|0.73|3.5||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of patients who reported they wished their providers had been more involved, compared to right amount (ref)||3.50|0.73|0.24
71038299|NCT01243151|141583764|SUPERIORITY_OR_OTHER||LS Mean Difference|1.76|STANDARD_ERROR_OF_MEAN|3.279||0.5936|TWO_SIDED|95.0|-4.81|8.33|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||8.33|-4.81|0.5936
71038300|NCT01243151|141583764|SUPERIORITY_OR_OTHER||LS Mean Difference|9.78|STANDARD_ERROR_OF_MEAN|3.192||0.0034|TWO_SIDED|95.0|3.38|16.17|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||16.17|3.38|0.0034
71038301|NCT01243151|141583764|SUPERIORITY_OR_OTHER||LS Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|3.428||0.0305|TWO_SIDED|95.0|0.74|14.46|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||14.46|0.74|0.0305
71038302|NCT01243151|141583764|SUPERIORITY_OR_OTHER||LS Mean Difference|5.41|STANDARD_ERROR_OF_MEAN|3.479||0.1252|TWO_SIDED|95.0|-1.55|12.37|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||12.37|-1.55|0.1252
71038303|NCT01243151|141583764|SUPERIORITY_OR_OTHER||LS Mean Difference|3.71|STANDARD_ERROR_OF_MEAN|3.495||0.2923|TWO_SIDED|95.0|-3.28|10.71|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||10.71|-3.28|0.2923
71038304|NCT01243151|141583764|SUPERIORITY_OR_OTHER||LS Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|3.411||0.0297|TWO_SIDED|95.0|0.78|14.43|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||14.43|0.78|0.0297
71038305|NCT01243151|141583765|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.35|STANDARD_ERROR_OF_MEAN|4.117|<|0.0001|TWO_SIDED|95.0|-34.59|-18.1|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-18.10|-34.59|<0.0001
71098456|NCT03016403|141704952|SUPERIORITY||Mean Difference (Final Values)|-15.31||||0.0061|TWO_SIDED|95.0|-26.23|-4.39||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of an interaction between time and intervention arm.|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|Linear mixed models (LMM) have been used with time and the interaction between time and group as fixed effects. A structure of random effects that includes random intercepts for patients was used. The study was powered for testing the hypothesis of no group differences in change over the four time points. A significant group by time interaction was hypothesized.||-4.39|-26.23|0.0061
71098457|NCT03016403|141704953|SUPERIORITY||Mean Difference (Final Values)|-7.73||||0.21|TWO_SIDED|95.0|-19.73|4.27||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||4.27|-19.73|0.21
71038306|NCT01243151|141583765|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.29|STANDARD_ERROR_OF_MEAN|4.325|<|0.0001|TWO_SIDED|95.0|-32.95|-15.63|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-15.63|-32.95|<0.0001
71038307|NCT01243151|141583765|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.2|STANDARD_ERROR_OF_MEAN|4.182|<|0.0001|TWO_SIDED|95.0|-39.58|-22.83|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-22.83|-39.58|<0.0001
70987828|NCT02078713|141484638|SUPERIORITY||Relative risk ratio|1.0||||0.997|TWO_SIDED|95.0|0.45|2.25||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of patients who wished provider had expressed preference less strongly to right amount (ref).||2.25|0.45|0.997
70987829|NCT02078713|141484638|SUPERIORITY||Relative risk ratio|0.69||||0.16|TWO_SIDED|95.0|0.41|1.16||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of patients who reported they wished provider had expressed preference more strongly, compared to right amount (ref).||1.16|0.41|0.16
71038308|NCT01243151|141583765|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.43|STANDARD_ERROR_OF_MEAN|4.169|<|0.0001|TWO_SIDED|95.0|-38.78|-22.08|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-22.08|-38.78|<0.0001
71038309|NCT01243151|141583765|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.3|STANDARD_ERROR_OF_MEAN|5.055|<|0.0001|TWO_SIDED|95.0|-43.42|-23.19|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-23.19|-43.42|<0.0001
71038310|NCT01243151|141583765|SUPERIORITY_OR_OTHER||LS Mean Difference|-34.14|STANDARD_ERROR_OF_MEAN|5.255|<|0.0001|TWO_SIDED|95.0|-44.65|-23.63|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-23.63|-44.65|<0.0001
71038311|NCT01243151|141583765|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.57|STANDARD_ERROR_OF_MEAN|5.194|<|0.0001|TWO_SIDED|95.0|-52.96|-32.18|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-32.18|-52.96|<0.0001
71038312|NCT01243151|141583765|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.87|STANDARD_ERROR_OF_MEAN|5.097|<|0.0001|TWO_SIDED|95.0|-52.07|-31.67|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-31.67|-52.07|<0.0001
71038313|NCT01243151|141583765|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.75|STANDARD_ERROR_OF_MEAN|4.343|<|0.0001|TWO_SIDED|95.0|-46.46|-29.05|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.05|-46.46|<0.0001
71038314|NCT01243151|141583765|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.98|STANDARD_ERROR_OF_MEAN|4.519|<|0.0001|TWO_SIDED|95.0|-50.04|-31.93|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-31.93|-50.04|<0.0001
71038315|NCT01243151|141583765|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.98|STANDARD_ERROR_OF_MEAN|4.441|<|0.0001|TWO_SIDED|95.0|-55.88|-38.08|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-38.08|-55.88|<0.0001
71038316|NCT01243151|141583765|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.77|STANDARD_ERROR_OF_MEAN|4.363|<|0.0001|TWO_SIDED|95.0|-54.52|-37.03|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-37.03|-54.52|<0.0001
71038317|NCT01243151|141583765|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.61|STANDARD_ERROR_OF_MEAN|4.616|<|0.0001|TWO_SIDED|95.0|-47.85|-29.37|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.37|-47.85|<0.0001
71038318|NCT01243151|141583765|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.19|STANDARD_ERROR_OF_MEAN|4.795|<|0.0001|TWO_SIDED|95.0|-50.78|-31.6|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-31.60|-50.78|<0.0001
71098458|NCT03016403|141704954|SUPERIORITY||Mean Difference (Final Values)|1.52||||0.052|TWO_SIDED|95.0|-0.01|3.05||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||3.05|-0.01|0.052
71098459|NCT03016403|141704955|SUPERIORITY||Mean Difference (Final Values)|0.91||||0.214|TWO_SIDED|95.0|-0.52|2.36||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||2.36|-0.52|0.214
70987830|NCT02078713|141484639|SUPERIORITY|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|Odds Ratio (OR)|1.3||||0.13|TWO_SIDED|95.0|0.93|1.82||P-value calculated in multiply imputed dataset.|Regression, Logistic||The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||1.82|0.93|0.13
70987831|NCT02078713|141484640|SUPERIORITY||Relative risk ratio|1.13||||0.5|TWO_SIDED|95.0|0.79|1.61||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of patient decision to both (ref)||1.61|0.79|0.50
70987832|NCT02078713|141484640|SUPERIORITY||Relative risk ratio|2.14||||0.09|TWO_SIDED|95.0|0.89|5.15||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of provider decision to both (ref)||5.15|0.89|0.09
70987833|NCT02078713|141484641|SUPERIORITY||Odds Ratio (OR)|1.27||||0.12|TWO_SIDED|95.0|0.94|1.71||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||1.71|0.94|0.12
70987834|NCT02078713|141484642|SUPERIORITY||Odds Ratio (OR)|1.18||||0.41|TWO_SIDED|95.0|0.8|1.74||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of overall score||1.74|0.80|0.41
70987835|NCT02078713|141484642|SUPERIORITY||Odds Ratio (OR)|1.34||||0.0496|TWO_SIDED|95.0|1.0|1.8|||Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of informed decision subscale||1.80|1.00|0.0496
70987836|NCT02078713|141484642|SUPERIORITY||Odds Ratio (OR)|1.45||||0.03|TWO_SIDED|95.0|1.03|2.05||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of uncertainty subscale of DCS||2.05|1.03|0.03
70987837|NCT02078713|141484642|SUPERIORITY||Odds Ratio (OR)|1.13||||0.5|TWO_SIDED|95.0|0.8|1.59||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of effective decision subscale||1.59|0.80|0.5
71098460|NCT03016403|141704956|SUPERIORITY||Mean Difference (Final Values)|-4.16||||0.0134|TWO_SIDED|95.0|-7.45|-0.87||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||-0.87|-7.45|0.0134
71098461|NCT03016403|141704957|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.42|TWO_SIDED|95.0|-0.9|2.12||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||2.12|-0.9|0.42
70987838|NCT02078713|141484642|SUPERIORITY||Odds Ratio (OR)|1.17||||0.31|TWO_SIDED|95.0|0.86|1.59||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of values clarity subscale||1.59|0.86|0.31
70987839|NCT02078713|141484642|SUPERIORITY||Odds Ratio (OR)|1.06||||0.73|TWO_SIDED|95.0|0.76|1.49||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of support subscale||1.49|0.76|0.73
70987840|NCT02078713|141484643|SUPERIORITY||Odds Ratio (OR)|1.27||||0.12|TWO_SIDED|95.0|0.94|1.72||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - pills are more effective than condoms||1.72|0.94|0.12
70987841|NCT02078713|141484643|SUPERIORITY||Odds Ratio (OR)|2.65|||<|0.0001|TWO_SIDED|95.0|1.94|3.62||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - IUDs are more effective than pills||3.62|1.94|<0.0001
70987842|NCT02078713|141484643|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0004|TWO_SIDED|95.0|1.29|2.44||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - depo is more effective than condoms||2.44|1.29|0.0004
70987843|NCT02078713|141484643|SUPERIORITY||Odds Ratio (OR)|1.92||||0.0002|TWO_SIDED|95.0|1.36|2.71||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - IUDs are an option for nulliparous young women||2.71|1.36|0.0002
70987844|NCT02078713|141484643|SUPERIORITY||Odds Ratio (OR)|1.86||||0.001|TWO_SIDED|95.0|1.28|2.71||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - Methods causing periods to stop are safe.||2.71|1.28|0.001
70987845|NCT02078713|141484643|SUPERIORITY||Odds Ratio (OR)|1.15||||0.36|TWO_SIDED|95.0|0.85|1.57||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - LARC can be removed early||1.57|0.85|0.36
70987846|NCT02078713|141484643|SUPERIORITY||Odds Ratio (OR)|2.76|||<|0.0001|TWO_SIDED|95.0|1.72|4.41||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of knowledge - Copper IUD can act as EC||4.41|1.72|<0.0001
70987847|NCT02078713|141484643|SUPERIORITY||Odds Ratio (OR)|0.77||||0.49|TWO_SIDED|95.0|0.36|1.63||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a regression model in a multiply imputed dataset. This outcome was not adjusted for site due to model being unable to run with imputed data.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of knowledge - After sex, there is something you can do to prevent pregnancy||1.63|0.36|0.49
71038319|NCT01243151|141583765|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.75|STANDARD_ERROR_OF_MEAN|4.722|<|0.0001|TWO_SIDED|95.0|-59.2|-40.3|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-40.30|-59.20|<0.0001
71038320|NCT01243151|141583765|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.04|STANDARD_ERROR_OF_MEAN|4.639|<|0.0001|TWO_SIDED|95.0|-57.33|-38.76|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-38.76|-57.33|<0.0001
71038321|NCT01243151|141583766|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.7|STANDARD_ERROR_OF_MEAN|4.211|<|0.0001|TWO_SIDED|95.0|-31.06|-14.34|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-14.34|-31.06|<0.0001
70987848|NCT02078713|141484643|SUPERIORITY||Odds Ratio (OR)|0.73||||0.31|TWO_SIDED|95.0|0.39|1.34||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a regression model in a multiply imputed dataset. This outcome was not adjusted for site due to model being unable to run with imputed data.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of knowledge - EC can prevent pregnancy after sex||1.34|0.39|0.31
70987849|NCT02078713|141484643|SUPERIORITY||Odds Ratio (OR)|1.33||||0.08|TWO_SIDED|95.0|0.96|1.84||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - pill does not affect fertility||1.84|0.96|0.08
70987850|NCT02078713|141484643|SUPERIORITY||Odds Ratio (OR)|1.65||||0.002|TWO_SIDED|95.0|1.2|2.26||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.||Comparison of correct knowledge - patch does not affect fertility|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|2.26|1.2|0.002
70987851|NCT02078713|141484643|SUPERIORITY||Odds Ratio (OR)|1.7||||0.002|TWO_SIDED|95.0|1.23|2.35||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - ring does not affect fertility||2.35|1.23|0.002
70987852|NCT02078713|141484643|SUPERIORITY||Odds Ratio (OR)|0.94||||0.77|TWO_SIDED|95.0|0.62|1.43||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - Depo does affect fertility||1.43|0.62|0.77
70987853|NCT02078713|141484643|SUPERIORITY||Odds Ratio (OR)|1.61||||0.002|TWO_SIDED|95.0|1.19|2.17||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - Hormonal IUD does not affect fertility||2.17|1.19|0.002
70987854|NCT02078713|141484643|SUPERIORITY||Odds Ratio (OR)|1.56||||0.004|TWO_SIDED|95.0|1.15|2.1||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - Non-hormonal IUD does not affect fertility||2.1|1.15|0.004
70987855|NCT02078713|141484643|SUPERIORITY||Odds Ratio (OR)|1.54||||0.005|TWO_SIDED|95.0|1.14|2.07||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - Implant does not affect fertility||2.07|1.14|0.005
70987856|NCT02078713|141484643|SUPERIORITY||Odds Ratio (OR)|2.47|||<|0.0001|TWO_SIDED|95.0|1.75|3.49||P-value calculated in multiply imputed dataset.|Regression, Logistic||OR calculated in multiply imputed dataset. Intervention patients had 2.47 times the odds of control patients to give correct answer.|Comparison of correct knowledge - composite IUD knowledge item (all correct responses on items related to IUD knowledge, versus any incorrect)||3.49|1.75|<0.0001
70987857|NCT02078713|141484644|SUPERIORITY||Odds Ratio (OR)|1.19||||0.25|TWO_SIDED|95.0|0.88|1.61||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of percentage of patients giving top score at baseline||1.61|0.88|0.25
70987858|NCT02078713|141484644|SUPERIORITY||Odds Ratio (OR)|0.9||||0.5|TWO_SIDED|95.0|0.66|1.22||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention groups in the numerator over the odds of the control group in the denominator.|Comparison of percentage of patients giving top score at 4 months post-enrollment||1.22|0.66|0.5
70987859|NCT02078713|141484644|SUPERIORITY||Odds Ratio (OR)|0.83||||0.23|TWO_SIDED|95.0|0.6|1.13||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of percentage of patients giving a top score on the 5-point Likert scale at 7 months post-enrollment.||1.13|0.60|0.23
70987860|NCT02078713|141484645|SUPERIORITY||Odds Ratio (OR)|0.91||||0.55|TWO_SIDED|95.0|0.66|1.25||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||1.25|0.66|0.55
70987861|NCT02078713|141484646|SUPERIORITY||Odds Ratio (OR)|1.22||||0.13|TWO_SIDED|95.0|0.92|1.6||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating for hormonal IUD. Patients excluded from analysis if they had not heard of hormonal IUD.||1.6|0.92|0.13
70987862|NCT02078713|141484646|SUPERIORITY||Odds Ratio (OR)|0.99||||0.92|TWO_SIDED|95.0|0.75|1.3||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on non-hormonal IUD. Patients were excluded from this analysis if they reported not having heard of the non-hormonal IUD in the post-visit survey.||1.3|0.75|0.92
70987863|NCT02078713|141484646|SUPERIORITY||Odds Ratio (OR)|0.85||||0.17|TWO_SIDED|95.0|0.67|1.07||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating of implant||1.07|0.67|0.17
70987864|NCT02078713|141484646|SUPERIORITY||Odds Ratio (OR)|0.71||||0.009|TWO_SIDED|95.0|0.54|0.92||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on condoms. Patients were excluded from this analysis if they reported not having heard of condoms in the post-visit survey.||0.92|0.54|0.009
70987865|NCT02078713|141484646|SUPERIORITY||Odds Ratio (OR)|0.86||||0.26|TWO_SIDED|95.0|0.65|1.12||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on the shot (Depo Provera). Patients were excluded from this analysis if they reported not having heard of the the shot (Depo Provera) in the post-visit survey.||1.12|0.65|0.26
70987866|NCT02078713|141484646|SUPERIORITY||Odds Ratio (OR)|0.85||||0.23|TWO_SIDED|95.0|0.64|1.11||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on the pill. Patients were excluded from this analysis if they reported not having heard of the pill in the post-visit survey.||1.11|0.64|0.23
70987867|NCT02078713|141484646|SUPERIORITY||Odds Ratio (OR)|0.92||||0.55|TWO_SIDED|95.0|0.69|1.22||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on the patch. Patients were excluded from this analysis if they reported not having heard of the patch in the post-visit survey.||1.22|0.69|0.55
70987868|NCT02078713|141484646|SUPERIORITY||Odds Ratio (OR)|0.97||||0.84|TWO_SIDED|95.0|0.76|1.25||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on the pull-out method. Patients were excluded from this analysis if they reported not having heard of the pull-out method in the post-visit survey.||1.25|0.76|0.84
70987869|NCT02078713|141484646|SUPERIORITY||Odds Ratio (OR)|0.81||||0.07|TWO_SIDED|95.0|0.64|1.02||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on the ring. Patients were excluded from this analysis if they reported not having heard of the ring in the post-visit survey.||1.02|0.64|0.07
70987870|NCT02078713|141484646|SUPERIORITY||Odds Ratio (OR)|0.59||||0.002|TWO_SIDED|95.0|0.42|0.82||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on female sterilization/tubal ligation. Patients were excluded from this analysis if they reported not having heard of female sterilization/tubal ligation in the post-visit survey.||0.82|0.42|0.002
70987871|NCT02078713|141484646|SUPERIORITY||Odds Ratio (OR)|0.58||||0.005|TWO_SIDED|95.0|0.4|0.85||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on male sterilization/vasectomy. Patients were excluded from this analysis if they reported not having heard of male sterilization/vasectomy in the post-visit survey.||0.85|0.4|0.005
70987872|NCT02078713|141484647|SUPERIORITY||Odds Ratio (OR)|1.55||||0.27|TWO_SIDED|95.0|0.71|3.42||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of hormonal IUD||3.42|0.71|0.27
71098462|NCT03016403|141704958|SUPERIORITY||Mean Difference (Final Values)|1.77||||0.0269|TWO_SIDED|95.0|0.2|3.34||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||3.34|0.2|0.0269
71098463|NCT03016403|141704959|SUPERIORITY||Mean Difference (Final Values)|2.56||||0.0044|TWO_SIDED|95.0|0.8|4.32||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||4.32|0.8|0.0044
70987873|NCT02078713|141484647|SUPERIORITY||Odds Ratio (OR)|1.65||||0.18|TWO_SIDED|95.0|0.8|3.4||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of non-hormonal IUD||3.40|0.80|0.18
70987874|NCT02078713|141484647|SUPERIORITY||Odds Ratio (OR)|1.29||||0.5|TWO_SIDED|95.0|0.62|2.69||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of implant||2.69|0.62|0.5
70987875|NCT02078713|141484647|SUPERIORITY||Odds Ratio (OR)|1.7||||0.32|TWO_SIDED|95.0|0.59|4.89||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of the patch||4.89|0.59|0.32
70987876|NCT02078713|141484647|SUPERIORITY||Odds Ratio (OR)|1.38||||0.37|TWO_SIDED|95.0|0.68|2.81||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of ring||2.81|0.68|0.37
70987877|NCT02078713|141484647|SUPERIORITY||Odds Ratio (OR)|1.49||||0.39|TWO_SIDED|95.0|0.6|3.73||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of male sterilization (vasectomy)||3.73|0.60|0.39
70987878|NCT02078713|141484647|SUPERIORITY||Odds Ratio (OR)|1.49||||0.39|TWO_SIDED|95.0|0.6|3.73||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of female sterilization||3.73|0.6|0.39
70987879|NCT02078713|141484648|SUPERIORITY||Odds Ratio (OR)|1.27||||0.18|TWO_SIDED|95.0|0.9|1.81||P-value calculated from multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|"The odds ratio represents the odds of the intervention group rating their appointment as much better, in the numerator, over the odds of the control group giving this rating in the denominator."|Patients excluded from test if they reported not having had a previous contraceptive counseling appointment.||1.81|0.90|0.18
70987880|NCT02078713|141484649|SUPERIORITY||Mean Difference (Final Values)|11.81|||<|0.001|TWO_SIDED|95.0|8.54|18.66||P-value calculated in multiple imputed dataset|Regression, Linear|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation parameter is a beta coefficient from a linear regression model, calculated in an imputed dataset. It represents additional minutes in an intervention visit versus a control visit.|||18.66|8.54|<0.001
70987881|NCT02078713|141484650|SUPERIORITY||Mean Difference (Final Values)|1.05||||0.63|TWO_SIDED|95.0|-3.19|5.29||P-value calculated in multiply imputed dataset|Regression, Linear|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation parameter is a beta coefficient from a linear regression model, calculated in an imputed dataset. It represents additional minutes in an intervention visit versus a control visit.|||5.29|-3.19|0.63
70987882|NCT02078713|141484651|SUPERIORITY||Observed coefficient|-3.97|STANDARD_ERROR_OF_MEAN|3.34||0.24|TWO_SIDED|95.0|-10.62|2.68|||Regression, Linear||Tool group is compared to control group (ref). Bootstrapping used for standard error.|Test of follow-up score of emotional exhaustion subscale of Maslach Burnout Inventory, controlling for baseline score and site||2.68|-10.62|0.24
70987883|NCT02078713|141484651|SUPERIORITY||Observed coefficient|-1.52|STANDARD_ERROR_OF_MEAN|1.91||0.36|TWO_SIDED|95.0|-4.76|1.72|||Regression, Linear||Tool group is compared to control group (ref). Bootstrapping used for standard error|Linear regression of follow-up score for depersonalization subscale of Maslach Burnout Inventory, controlling for baseline score and site.||1.72|-4.76|0.36
70987884|NCT02078713|141484651|SUPERIORITY||Slope|-1.64|STANDARD_ERROR_OF_MEAN|1.34||0.28|TWO_SIDED|95.0|-4.61|1.34|||Regression, Linear||Tool group compared to control group (ref). Bootstrapping used for standard error.|Linear regression of follow-up score for personal accomplishment subscale of Maslach Burnout Inventory, controlling for site and baseline score.||1.34|-4.61|0.28
71038322|NCT01243151|141583766|SUPERIORITY_OR_OTHER||LS Mean Difference|-18.6|STANDARD_ERROR_OF_MEAN|4.315|<|0.0001|TWO_SIDED|95.0|-27.17|-10.03|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-10.03|-27.17|<0.0001
70987885|NCT02078713|141484652|SUPERIORITY||Odds Ratio (OR)|1.06||||0.78|TWO_SIDED|95.0|0.69|1.65||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||1.65|0.69|0.78
71038323|NCT01243151|141583766|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.97|STANDARD_ERROR_OF_MEAN|4.274|<|0.0001|TWO_SIDED|95.0|-36.46|-19.49|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-19.49|-36.46|<0.0001
70987886|NCT02078713|141484653|SUPERIORITY||Odds Ratio (OR)|0.94||||0.75|TWO_SIDED|95.0|0.66|1.35||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 4 months post-enrollment||1.35|0.66|0.75
70987887|NCT02078713|141484653|SUPERIORITY||Odds Ratio (OR)|1.07||||0.71|TWO_SIDED|95.0|0.75|1.53||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 7 months post-enrollment||1.53|0.75|0.71
70987888|NCT02078713|141484654|SUPERIORITY||Odds Ratio (OR)|0.94||||0.75|TWO_SIDED|95.0|0.66|1.34||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 4 months post-enrollment||1.34|0.66|0.75
70987889|NCT02078713|141484654|SUPERIORITY||Odds Ratio (OR)|1.17||||0.37|TWO_SIDED|95.0|0.83|1.64||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 7 months post-enrollment||1.64|0.83|0.37
71038324|NCT01243151|141583766|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.89|STANDARD_ERROR_OF_MEAN|4.207|<|0.0001|TWO_SIDED|95.0|-33.24|-16.54|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-16.54|-33.24|<0.0001
71038325|NCT01243151|141583766|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.89|STANDARD_ERROR_OF_MEAN|4.211|<|0.0001|TWO_SIDED|95.0|-37.25|-20.53|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-20.53|-37.25|<0.0001
71038326|NCT01243151|141583766|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.35|STANDARD_ERROR_OF_MEAN|4.315|<|0.0001|TWO_SIDED|95.0|-34.92|-17.79|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-17.79|-34.92|<0.0001
71038327|NCT01243151|141583766|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.89|STANDARD_ERROR_OF_MEAN|4.318|<|0.0001|TWO_SIDED|95.0|-44.46|-27.33|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-27.33|-44.46|<0.0001
71038328|NCT01243151|141583766|SUPERIORITY_OR_OTHER||LS Mean Difference|-34.23|STANDARD_ERROR_OF_MEAN|4.207|<|0.0001|TWO_SIDED|95.0|-42.58|-25.88|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-25.88|-42.58|<0.0001
71038329|NCT01243151|141583766|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.96|STANDARD_ERROR_OF_MEAN|4.246|<|0.0001|TWO_SIDED|95.0|-42.39|-25.53|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-25.53|-42.39|<0.0001
71038330|NCT01243151|141583766|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.41|STANDARD_ERROR_OF_MEAN|4.315|<|0.0001|TWO_SIDED|95.0|-43.98|-26.85|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-26.85|-43.98|<0.0001
71038331|NCT01243151|141583766|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.28|STANDARD_ERROR_OF_MEAN|4.318|<|0.0001|TWO_SIDED|95.0|-51.85|-34.71|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-34.71|-51.85|<0.0001
71038332|NCT01243151|141583766|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.0|STANDARD_ERROR_OF_MEAN|4.207|<|0.0001|TWO_SIDED|95.0|-46.35|-29.65|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.65|-46.35|<0.0001
71038333|NCT01243151|141583766|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.77|STANDARD_ERROR_OF_MEAN|4.246|<|0.0001|TWO_SIDED|95.0|-38.19|-21.34|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-21.34|-38.19|<0.0001
71038334|NCT01243151|141583766|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.22|STANDARD_ERROR_OF_MEAN|4.315|<|0.0001|TWO_SIDED|95.0|-39.79|-22.65|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-22.65|-39.79|<0.0001
71038335|NCT01243151|141583766|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.34|STANDARD_ERROR_OF_MEAN|4.318|<|0.0001|TWO_SIDED|95.0|-49.91|-32.78|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-32.78|-49.91|<0.0001
70987890|NCT02078713|141484655|SUPERIORITY||Odds Ratio (OR)|1.27||||0.63|TWO_SIDED|95.0|0.48|3.37||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 4 months post-enrollment||3.37|0.48|0.63
70987891|NCT02078713|141484655|SUPERIORITY||Odds Ratio (OR)|1.83||||0.11|TWO_SIDED|95.0|0.88|3.8||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 7 months post-enrollment||3.80|0.88|0.11
70987892|NCT00696657|141484664|SUPERIORITY||Estimated treatment differences|-1.19|||<|0.0001|TWO_SIDED|95.0|-1.58|-0.8|||ANOVA|Confidence interval (CIs) for treatment differences versus placebo are based on Dunnett's method.||"The comparison sequence should be read as Semaglutide 1.6 mg (with titration) - Placebo. The estimates are from an analysis of variance (ANOVA) model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.80|-1.58|<0.0001
70987893|NCT00696657|141484664|SUPERIORITY||Estimated treatment differences|-0.95|||<|0.0001|TWO_SIDED|95.0|-1.33|-0.57|||ANOVA|CIs for treatment differences versus placebo are based on Dunnett's method.||"The comparison sequence should be read as Semaglutide 0.8 mg (with titration) - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.57|-1.33|<0.0001
70987894|NCT00696657|141484664|SUPERIORITY||Estimated treatment differences|-0.97|||<|0.0001|TWO_SIDED|95.0|-1.35|-0.59|||ANOVA|CIs for treatment differences versus placebo are based on Dunnett's method.||"The comparison sequence should be read as Semaglutide 0.8 mg - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.59|-1.35|<0.0001
70987895|NCT00696657|141484664|SUPERIORITY||Estimated treatment differences|-0.61||||0.0002|TWO_SIDED|95.0|-0.98|-0.23|||ANOVA|CIs for treatment differences versus placebo are based on Dunnett's method.||"The comparison sequence should be read as Semaglutide 0.4 mg - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.23|-0.98|0.0002
70987896|NCT00696657|141484664|SUPERIORITY||Estimated treatment differences|-0.41||||0.0324|TWO_SIDED|95.0|-0.79|-0.02|||ANOVA|CIs for treatment differences versus placebo are based on Dunnett's method.||"The comparison sequence should be read as Semaglutide 0.2 mg - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.02|-0.79|0.0324
70987897|NCT00696657|141484664|SUPERIORITY||Estimated treatment differences|-0.09||||0.9772|TWO_SIDED|95.0|-0.46|0.28|||ANOVA|CIs for treatment differences versus placebo are based on Dunnett's method.||"The comparison sequence should be read as Semaglutide 0.1 mg - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.28|-0.46|0.9772
70987898|NCT00696657|141484664|OTHER||Estimated treatment differences|-0.35|||||TWO_SIDED|95.0|-0.64|-0.06|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 1.6 mg (with titration) - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.06|-0.64|
70987899|NCT00696657|141484664|OTHER||Estimated treatment differences|-0.11|||||TWO_SIDED|95.0|-0.39|0.18|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.8 mg (with titration) - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.18|-0.39|
70987900|NCT00696657|141484664|OTHER||Estimated treatment differences|-0.13|||||TWO_SIDED|95.0|-0.42|0.16|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.8 mg - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.16|-0.42|
70987901|NCT00696657|141484664|OTHER||Estimated treatment differences|0.24|||||TWO_SIDED|95.0|-0.05|0.52|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.4 mg - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.52|-0.05|
70987902|NCT00696657|141484664|OTHER||Estimated treatment differences|0.44|||||TWO_SIDED|95.0|0.15|0.73|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.2 mg - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.73|0.15|
70987903|NCT00696657|141484664|OTHER||Estimated treatment differences|0.75|||||TWO_SIDED|95.0|0.48|1.03|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.1 mg - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||1.03|0.48|
71038336|NCT01243151|141583766|SUPERIORITY_OR_OTHER||LS Mean Difference|-36.04|STANDARD_ERROR_OF_MEAN|4.207|<|0.0001|TWO_SIDED|95.0|-44.39|-27.69|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-27.69|-44.39|<0.0001
71038337|NCT01243151|141583767|SUPERIORITY_OR_OTHER||LS Mean Difference|4.44|STANDARD_ERROR_OF_MEAN|3.975||0.269|TWO_SIDED|95.0|-3.53|12.41|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||12.41|-3.53|0.2690
70987904|NCT00696657|141484664|OTHER||Estimated treatment differences|-0.84|||||TWO_SIDED|95.0|-1.12|-0.56|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Liraglutide 1.8 mg - Placebo . The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.56|-1.12|
70987905|NCT00696657|141484664|OTHER||Estimated treatment differences|-0.51|||||TWO_SIDED|95.0|-0.8|-0.22|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 1.6 mg (with titration) - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.22|-0.80|
70987906|NCT00696657|141484664|OTHER||Estimated treatment differences|-0.27|||||TWO_SIDED|95.0|-0.56|0.02|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.8 mg (with titration) - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.02|-0.56|
70987907|NCT00696657|141484664|OTHER||Estimated treatment differences|-0.29|||||TWO_SIDED|95.0|-0.58|0.01|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.8 mg - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.01|-0.58|
70987908|NCT00696657|141484664|OTHER||Estimated treatment differences|0.08|||||TWO_SIDED|95.0|-0.22|0.37|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.4 mg - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.37|-0.22|
70987909|NCT00696657|141484664|OTHER||Estimated treatment differences|0.28|||||TWO_SIDED|95.0|-0.02|0.57|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.2 mg - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.57|-0.02|
70987910|NCT00696657|141484664|OTHER||Estimated treatment differences|0.59|||||TWO_SIDED|95.0|0.31|0.88|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.1 mg - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.88|0.31|
70987911|NCT00696657|141484664|OTHER||Estimated treatment differences|-0.68|||||TWO_SIDED|95.0|-0.97|-0.4|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Liraglutide 1.2 mg - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.40|-0.97|
70987912|NCT04688346|141484701|NON_INFERIORITY|t-test|Mean Difference (Final Values)|1.0||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
70987913|NCT00059215|141484703|SUPERIORITY_OR_OTHER|||||||0.933||95.0|||||Fisher Exact|||||||0.933
70987914|NCT00059215|141484703|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||Log Rank|||||||0.590
71098464|NCT00564070|141704965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.2|||<|0.0001|TWO_SIDED|95.0|17.37|42.9|||Mixed Models Analysis|General linear model, controlling for baseline values|The Mean Difference was calculated as percent adherence to glucose monitoring for the CBT-AD Arm minus the adherence to glucose monitoring for the Enhanced Treatment as Usual Arm.|Multiple imputation was used to handle missing data; analyses are reported for the acute outcomes of glucose monitoring (i.e., 4 month)||42.9|17.37|<.0001
71098465|NCT00564070|141704966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72|||=|0.001|TWO_SIDED|95.0|0.29|1.15|||ANCOVA|General linear model; Controlling for baseline values|The Mean Difference was calculated as percent of HbA1c for the Enhanced Treatment as Usual Arm minus percent of HbA1c for the CBT-AD Arm.|Multiple imputation was used to handle missing data; results are reported for HbA1c at the acute outcome (i.e., 4 months)||1.15|.29|=.001
71098466|NCT00564070|141704967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.7|||<|0.0001|TWO_SIDED|95.0|10.22|31.14|||Mixed Models Analysis||The Mean Difference was calculated as percent pill adherence via MEMs for the CBT-AD Arm minus the percent pill adherence for the Enhanced Treatment as Usual Arm.|Analyses are reported for the acute outcomes of MEMs monitoring (4 month). Higher percentages represent better adherence.||31.14|10.22|<0.0001
71098467|NCT00564070|141704968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.22|||=|0.002|TWO_SIDED|95.0|2.33|10.56|||Mixed Models Analysis|General linear model, controlling for baseline values.|The Mean Difference was calculated as MADRS unit scale for the CBT-AD Arm minus the MADRS unit scale for the Enhanced Treatment as Usual Arm.|Analyses are reported for the acute outcomes of depression as assessed on the MADRS at acute outcome.||10.56|2.33|=.002
70987915|NCT00059215|141484704|SUPERIORITY_OR_OTHER|||||||0.945||95.0|||||Fisher Exact|||||||0.945
70987916|NCT00059215|141484704|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Log Rank|||||||0.260
70987917|NCT00059215|141484705|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
70987918|NCT00059215|141484705|SUPERIORITY_OR_OTHER|||||||0.544||95.0|||||Log Rank|||||||0.544
70987919|NCT00059215|141484706|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Fisher Exact|||||||0.370
70987920|NCT04985799|141484710|NON_INFERIORITY|For the sample size, a total of 143 participants, or 72 participants per group was needed, based on a 90% effectiveness for both slings 14% non-inferiority margin, 80% power, alpha of 0.05 and a 20% dropout rate.|Risk Difference (RD)|14.8||||0.04|TWO_SIDED|95.0|1.1|28.5|||Chi-squared|||||28.5|1.1|0.04
70987921|NCT04985799|141484711|NON_INFERIORITY|For the sample size, a total of 143 participants, or 72 participants per group was needed, based on a 90% effectiveness for both slings 14% non-inferiority margin, 80% power, alpha of 0.05 and a 20% dropout rate.|Risk Difference (RD)|7.4||||0.29|TWO_SIDED|95.0|-6.2|21.1|||Chi-squared|||||21.1|-6.2|0.29
70987922|NCT04985799|141484713|SUPERIORITY|||||||0.11|||||||Chi-squared|||||||0.11
70987923|NCT04494633|141484714|SUPERIORITY|||||||0.482314|||||||t-test, 2 sided|The change for each group was analyzed using a 2-tailed, unpaired, independent means, t-test with 61 degrees of freedom.||||||0.482314
70987924|NCT04494633|141484715|SUPERIORITY|||||||0.876964|||||||t-test, 2 sided|The change for each group was analyzed using a 2-tailed, unpaired, independent means, t test with 61 degrees of freedom.||||||.876964
70987925|NCT04494633|141484716|SUPERIORITY|||||||0.66602|||||||t-test, 2 sided|The change for each group was analyzed using a 2-tailed, unpaired, independent means, with 61 degrees of freedom.||||||.66602
70987926|NCT04494633|141484717|SUPERIORITY|||||||0.726421|||||||t-test, 2 sided|Two-tailed unpaired t test comparing change for control (Pre to 2 weeks later) to case (Pre- to 2 weeks post) with 61 degrees of freedom.||||||.726421
70987927|NCT04494633|141484718|SUPERIORITY|||||||0.908468|||||||t-test, 2 sided|The statistical test used was a 2 tailed, unpaired t test with 61 degrees of freedom.||||||0.908468
70987928|NCT04494633|141484719|SUPERIORITY|||||||0.468104|||||||t-test, 2 sided|The groups were compared using a two tailed unpaired t test with 61 degrees of freedom.||||||.468104
70987929|NCT01254604|141484723|NON_INFERIORITY_OR_EQUIVALENCE|The study was planned to enroll 248 subjects (124 per treatment group) to yield approximately 230 evaluable subjects (115 per treatment group). The study had power of 90% to test the primary hypothesis. The power and sample size were based on the following assumptions for treatment difference in change from baseline in IOP at Week 4: α = 0.025 (1-sided), Non-inferiority margin = 1.5 mmHg, True treatment difference = 0 mmHg, Standard deviation = 3.5 mmHg.|Difference in Least Squares Means|-1.7|||||TWO_SIDED|95.0|-2.6|-0.7|||ANCOVA|Analysis model includes terms for treatment, baseline IOP and ocular diagnosis (open-angle glaucoma or ocular hypertension)|Difference is tafluprost - timolol|The study hypothesis was that tafluprost is non-inferior to timolol with respect to change from baseline in diurnal IOP at Week 4 in participants with open-angle glaucoma or ocular hypertension. The study hypothesis would be met if the upper bound of the two-sided 95% confidence interval for the between-treatment difference in mean diurnal IOP change from baseline at Week4 (tafluprost - timolol) was ≤1.5 mmHg.||-0.7|-2.6|
70987930|NCT01254604|141484724|SUPERIORITY_OR_OTHER||Difference in percentage|19.5|||||TWO_SIDED|95.0|5.7|33.4|||Stratified Miettinen and Nurminen method|Participants were stratified by baseline IOP (\<26 mmHg or ≥26 mmHg at 0800 hours) and ocular diagnosis (open-angle glaucoma or ocular hypertension)|Between-group difference in percentage of participants with ≥25% reduction in IOP at Week 4 = percentage (tafluprost) - percentage (timolol)|||33.4|5.7|
70987931|NCT01254604|141484725|SUPERIORITY_OR_OTHER||Difference in percentage|-3.9|||||TWO_SIDED|95.0|-17.3|9.4|||Miettinen and Nurminen||Between-group difference in percentage of participants with an AE = percentage (tafluprost) - percentage (timolol)|||9.4|-17.3|
70987932|NCT01254604|141484726|SUPERIORITY_OR_OTHER||Difference in percentage|1.1|||||TWO_SIDED|95.0|-3.5|5.7|||Miettinen and Nurminen||Between-group difference in percentage of participants discontinued study drug due to an AE = percentage (tafluprost) - percentage (timolol)|||5.7|-3.5|
70987933|NCT03074162|141484727|EQUIVALENCE|The statistical model was an variance (ANOVA) on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment for comparison of B with R.|Geometric Mean (gMean) Ratio (%)|45.54|STANDARD_ERROR_OF_MEAN|35.99|||TWO_SIDED|90.0|40.11|51.7|||ANOVA|Only the data for the comparison under investigation were included in the statistical analysis.|gMean Ratio=(B/R) \*100. Standard Error of the mean is actually intra-individual geometric coefficient of variation.|||51.70|40.11|
70987934|NCT03074162|141484727|EQUIVALENCE|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment for comparison of B with A.|Geometric Mean (gMean) Ratio (%)|85.56|STANDARD_ERROR_OF_MEAN|42.05|||TWO_SIDED|90.0|74.11|98.77|||ANOVA|Only the data for the comparison under investigation were included in the statistical analysis.|gMean Ratio=(B/A) \*100. Standard Error of the mean is actually intra-individual geometric coefficient of variation|||98.77|74.11|
70987935|NCT03074162|141484728|EQUIVALENCE|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment for comparison of B with R.|Geometric Mean (gMean) Ratio (%)|49.6|STANDARD_ERROR_OF_MEAN|38.13|||TWO_SIDED|90.0|43.39|56.71|||ANOVA|Only the data for the comparison under investigation were included in the statistical analysis.|gMean Ratio=(B/R) \*100. Standard Error of the mean is actually intra-individual geometric coefficient of variation.|||56.71|43.39|
71098468|NCT00564070|141704969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|||=|0.01|TWO_SIDED|95.0|0.16|1.32|||ANCOVA|using GLM|The Mean Difference was calculated as CGI unit scale for the Enhanced Treatment as Usual Arm minus the CGI unit scale for the CBT-AD Arm.|||1.32|.16|=.01
70987936|NCT03074162|141484728|EQUIVALENCE|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment for comparison of B with A.|Geometric Mean (gMean) Ratio (%)|83.57|STANDARD_ERROR_OF_MEAN|72.45|||TWO_SIDED|90.0|66.33|105.31|||ANOVA|Only the data for the comparison under investigation were included in the statistical analysis.|gMean Ratio=(B/A) \*100. Standard Error of the mean is actually intra-individual geometric coefficient of variation|||105.31|66.33|
71038338|NCT01243151|141583767|SUPERIORITY_OR_OTHER||LS Mean Difference|5.22|STANDARD_ERROR_OF_MEAN|4.133||0.2122|TWO_SIDED|95.0|-3.07|13.5|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||13.50|-3.07|0.2122
71038339|NCT01243151|141583767|SUPERIORITY_OR_OTHER||LS Mean Difference|0.54|STANDARD_ERROR_OF_MEAN|4.054||0.8953|TWO_SIDED|95.0|-7.59|8.67|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||8.67|-7.59|0.8953
71038340|NCT01243151|141583767|SUPERIORITY_OR_OTHER||LS Mean Difference|5.59|STANDARD_ERROR_OF_MEAN|4.045||0.1723|TWO_SIDED|95.0|-2.51|13.7|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||13.70|-2.51|0.1723
71038341|NCT01243151|141583767|SUPERIORITY_OR_OTHER||LS Mean Difference|14.95|STANDARD_ERROR_OF_MEAN|4.293||0.001|TWO_SIDED|95.0|6.34|23.56|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||23.56|6.34|0.0010
71038342|NCT01243151|141583767|SUPERIORITY_OR_OTHER||LS Mean Difference|10.86|STANDARD_ERROR_OF_MEAN|4.451||0.0179|TWO_SIDED|95.0|1.95|19.78|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||19.78|1.95|0.0179
71038343|NCT01243151|141583767|SUPERIORITY_OR_OTHER||LS Mean Difference|9.06|STANDARD_ERROR_OF_MEAN|4.44||0.0462|TWO_SIDED|95.0|0.16|17.96|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||17.96|0.16|0.0462
71038344|NCT01243151|141583767|SUPERIORITY_OR_OTHER||LS Mean Difference|11.78|STANDARD_ERROR_OF_MEAN|4.358||0.0091|TWO_SIDED|95.0|3.05|20.52|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||20.52|3.05|0.0091
71038345|NCT01243151|141583767|SUPERIORITY_OR_OTHER||LS Mean Difference|7.31|STANDARD_ERROR_OF_MEAN|4.064||0.0774|TWO_SIDED|95.0|-0.83|15.45|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||15.45|-0.83|0.0774
71038346|NCT01243151|141583767|SUPERIORITY_OR_OTHER||LS Mean Difference|7.16|STANDARD_ERROR_OF_MEAN|4.165||0.0909|TWO_SIDED|95.0|-1.18|15.5|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||15.50|-1.18|0.0909
71038347|NCT01243151|141583767|SUPERIORITY_OR_OTHER||LS Mean Difference|2.13|STANDARD_ERROR_OF_MEAN|4.157||0.6107|TWO_SIDED|95.0|-6.2|10.45|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||10.45|-6.20|0.6107
71038348|NCT01243151|141583767|SUPERIORITY_OR_OTHER||LS Mean Difference|11.59|STANDARD_ERROR_OF_MEAN|4.076||0.0062|TWO_SIDED|95.0|3.42|19.75|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||19.75|3.42|0.0062
71038349|NCT01243151|141583767|SUPERIORITY_OR_OTHER||LS Mean Difference|8.69|STANDARD_ERROR_OF_MEAN|4.712||0.0702|TWO_SIDED|95.0|-0.74|18.13|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||18.13|-0.74|0.0702
71038350|NCT01243151|141583767|SUPERIORITY_OR_OTHER||LS Mean Difference|6.69|STANDARD_ERROR_OF_MEAN|4.807||0.1692|TWO_SIDED|95.0|-2.93|16.32|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||16.32|-2.93|0.1692
71038351|NCT01243151|141583767|SUPERIORITY_OR_OTHER||LS Mean Difference|4.31|STANDARD_ERROR_OF_MEAN|4.819||0.3751|TWO_SIDED|95.0|-5.34|13.96|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||13.96|-5.34|0.3751
71038352|NCT01243151|141583767|SUPERIORITY_OR_OTHER||LS Mean Difference|13.65|STANDARD_ERROR_OF_MEAN|4.709||0.0053|TWO_SIDED|95.0|4.23|23.08|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||23.08|4.23|0.0053
71038353|NCT01243151|141583768|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.64|STANDARD_ERROR_OF_MEAN|3.951|<|0.0001|TWO_SIDED|95.0|-38.56|-22.72|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-22.72|-38.56|<0.0001
71038354|NCT01243151|141583768|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.62|STANDARD_ERROR_OF_MEAN|4.084|<|0.0001|TWO_SIDED|95.0|-34.8|-18.44|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-18.44|-34.80|<0.0001
71038355|NCT01243151|141583768|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.27|STANDARD_ERROR_OF_MEAN|4.003|<|0.0001|TWO_SIDED|95.0|-43.29|-27.24|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-27.24|-43.29|<0.0001
71038356|NCT01243151|141583768|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.42|STANDARD_ERROR_OF_MEAN|3.931|<|0.0001|TWO_SIDED|95.0|-41.3|-25.54|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-25.54|-41.30|<0.0001
71038357|NCT01243151|141583768|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.38|STANDARD_ERROR_OF_MEAN|5.467|<|0.0001|TWO_SIDED|95.0|-52.34|-30.42|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-30.42|-52.34|<0.0001
71038358|NCT01243151|141583768|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.12|STANDARD_ERROR_OF_MEAN|5.61|<|0.0001|TWO_SIDED|95.0|-49.36|-26.88|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-26.88|-49.36|<0.0001
71038359|NCT01243151|141583768|SUPERIORITY_OR_OTHER||LS Mean Difference|-47.42|STANDARD_ERROR_OF_MEAN|5.599|<|0.0001|TWO_SIDED|95.0|-58.64|-36.2|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-36.20|-58.64|<0.0001
70987937|NCT03041116|141484732|SUPERIORITY||Difference in LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.8|=|0.9115|TWO_SIDED|95.0|-1.69|1.51||p-value was derived from test of contrast between treatment effects using LSM estimate, adjusted for baseline score and age group from Type III analysis. The test of contrast at Week 24 was considered the primary comparison.|Mixed Models Analysis|||||1.51|-1.69|=0.9115
70987938|NCT03041116|141484734|SUPERIORITY||Difference in LS Mean|2.0|STANDARD_ERROR_OF_MEAN|1.38|=|0.1421|TWO_SIDED|95.0|-0.7|4.78||p-value was derived from the test of contrast between treatment effects using the LSM estimate, adjusted for baseline score and age group from the Type III analysis. The test of contrast at week 24 was considered the primary comparison.|Mixed Models Analysis|||||4.78|-0.7|=0.1421
70987939|NCT02436577|141484739|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|93.16|||||TWO_SIDED|90.0|85.8|101.15|||ANOVA|||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||101.15|85.80|
70987940|NCT02436577|141484739|SUPERIORITY_OR_OTHER||Geometric mean ratio|93.67|||||TWO_SIDED|90.0|87.88|99.84|||ANOVA|||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||99.84|87.88|
70987941|NCT02436577|141484739|SUPERIORITY_OR_OTHER||Geometric mean ratio|96.79|||||TWO_SIDED|90.0|88.27|106.14|||ANOVA|||Statistical Assessment of Bioequivalence for metabolite AR-C124910XX Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||106.14|88.27|
70987942|NCT02436577|141484739|SUPERIORITY_OR_OTHER||Geometric mean ratio|92.32|||||TWO_SIDED|90.0|85.04|100.23|||ANOVA|||Statistical Assessment of Bioequivalence for metabolite AR-C124910XX Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||100.23|85.04|
70987943|NCT02436577|141484740|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|97.76|||||TWO_SIDED|90.0|94.46|101.18|||ANOVA|||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||101.18|94.46|
70987944|NCT02436577|141484740|SUPERIORITY_OR_OTHER||Geometric Mean ratio|96.38|||||TWO_SIDED|90.0|93.24|99.63|||ANOVA|||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||99.63|93.24|
70987945|NCT02436577|141484740|SUPERIORITY_OR_OTHER||Geometric mean ratio|98.43|||||TWO_SIDED|90.0|94.75|102.25|||ANOVA|||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered compared to ticagrelor IR tablets.||102.25|94.75|
70987946|NCT02436577|141484740|SUPERIORITY_OR_OTHER||Geometric mean ratio|95.15|||||TWO_SIDED|90.0|91.59|98.85|||ANOVA|||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered compared to ticagrelor IR tablets.||98.85|91.59|
70987947|NCT02436577|141484741|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|97.75|||||TWO_SIDED|90.0|94.4|101.21|||ANOVA|||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||101.21|94.40|
71038360|NCT01243151|141583768|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.93|STANDARD_ERROR_OF_MEAN|5.453|<|0.0001|TWO_SIDED|95.0|-57.87|-36.0|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-36.00|-57.87|<0.0001
71038361|NCT01243151|141583768|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.37|STANDARD_ERROR_OF_MEAN|4.275|<|0.0001|TWO_SIDED|95.0|-53.96|-36.77|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-36.77|-53.96|<0.0001
71038362|NCT01243151|141583768|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.78|STANDARD_ERROR_OF_MEAN|4.374|<|0.0001|TWO_SIDED|95.0|-57.58|-39.99|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-39.99|-57.58|<0.0001
71038363|NCT01243151|141583768|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.49|STANDARD_ERROR_OF_MEAN|4.346|<|0.0001|TWO_SIDED|95.0|-63.23|-45.75|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-45.75|-63.23|<0.0001
70987948|NCT02436577|141484741|SUPERIORITY_OR_OTHER||Geometric mean ratio|96.5|||||TWO_SIDED|90.0|93.31|99.8|||ANOVA|||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||99.80|93.31|
71038364|NCT01243151|141583768|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.75|STANDARD_ERROR_OF_MEAN|4.222|<|0.0001|TWO_SIDED|95.0|-60.25|-43.26|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-43.26|-60.25|<0.0001
70987949|NCT02436577|141484741|SUPERIORITY_OR_OTHER||Geometric mean ratio|98.46|||||TWO_SIDED|90.0|94.85|102.2|||ANOVA|||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered compared to ticagrelor IR tablets.||102.20|94.85|
70987950|NCT02436577|141484741|SUPERIORITY_OR_OTHER||Geometric mean ratio|95.47|||||TWO_SIDED|90.0|91.99|99.08|||ANOVA|||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered compared to ticagrelor IR tablets.||99.08|91.99|
70987951|NCT00931892|141484785|OTHER|||||||0.67|||||||t-test, 2 sided|||||||0.670
70987952|NCT00931892|141484786|OTHER|||||||0.409|||||||t-test, 2 sided|||||||0.409
70987953|NCT00931892|141484787|OTHER|||||||0.387|||||||t-test, 2 sided|||||||0.387
70987954|NCT00931892|141484787|OTHER|||||||0.208|||||||t-test, 2 sided|||||||0.208
70987955|NCT00931892|141484788|SUPERIORITY|||||||0.01|||||||ANOVA|||P Value for IgA anti-tTG||||0.010
70987956|NCT00931892|141484788|SUPERIORITY|||||||0.036|||||||ANOVA|||P Value for IgA/IgG anti-DGP||||0.036
70987957|NCT00931892|141484788|SUPERIORITY|||||||0.013|||||||ANOVA|||P Value for IgA anti-tTG||||0.013
70987958|NCT00931892|141484788|SUPERIORITY|||||||0.006|||||||ANOVA|||P Value for IgA/IgG anti-DGP||||0.006
70987959|NCT00931892|141484790|OTHER|||||||0.05|||||||t-test, 2 sided|||P Value for Celiac Symptom Index (CSI) score for Day 3 of Gluten Challenge||||0.05
70987960|NCT00931892|141484790|OTHER|||||||0.02|||||||t-test, 2 sided|||P Value for Celiac Symptom Index (CSI) Score from baseline to Day 14||||0.020
70987961|NCT00931892|141484790|SUPERIORITY|||||||0.06|||||||ANOVA|||P Value for Celiac Symptom Index (CSI)score between high gluten group and low gluten group across study||||0.060
70987962|NCT00931892|141484792|OTHER|||||||0.01|||||||t-test, 2 sided|||P Value for the Gastrointestinal Symptom Rating Scale (GSRS) on Day 3 of the Gluten Challenge||||0.01
70987963|NCT00931892|141484792|OTHER|||||||0.012|||||||t-test, 2 sided|||P Value for Gastrointestinal Symptom Rating Scale (GSRS) from baseline to Day 14 of Gluten Challenge||||0.012
70987964|NCT00931892|141484792|SUPERIORITY|||||||0.09|||||||ANOVA|||P Value for Gastrointestinal Symptom Rating Scale (GSRS) between high gluten group and low gluten group across study||||0.090
70987965|NCT01876732|141484794|SUPERIORITY_OR_OTHER|||||||0.047||||||"P- value for social function"|Wilcoxon signed-rank test|||||||0.047
70987966|NCT01876732|141484794|SUPERIORITY_OR_OTHER|||||||0.688||||||"P- value of  symptom/problem list "|Wilcoxon signed-rank test|||||||0.688
70987967|NCT01876732|141484794|SUPERIORITY_OR_OTHER|||||||0.772||||||"P- value of  effects of kidney disease "|Wilcoxon signed-rank test|||||||0.772
70987968|NCT01876732|141484794|SUPERIORITY_OR_OTHER|||||||0.301||||||"P-value of  burden of kidney disease "|Wilcoxon signed-rank test|||||||0.301
70987969|NCT01876732|141484794|SUPERIORITY_OR_OTHER|||||||0.25||||||"P-value of  work status "|Wilcoxon signed-rank test|||||||0.250
70987970|NCT01876732|141484794|SUPERIORITY_OR_OTHER|||||||0.895||||||"P-value of  cognitive function "|Wilcoxon signed-rank test|||||||0.895
70987971|NCT01876732|141484794|SUPERIORITY_OR_OTHER|||||||0.281||||||"P-value of  quality of social interaction "|Wilcoxon signed-rank test|||||||0.281
70987972|NCT01876732|141484794|SUPERIORITY_OR_OTHER|||||||1||||||"P-value of  sleep "|Wilcoxon signed-rank test|||||||1.00
70987973|NCT01876732|141484794|SUPERIORITY_OR_OTHER|||||||1||||||"P-value of  social support "|Wilcoxon signed-rank test|||||||1.00
70987974|NCT01876732|141484794|SUPERIORITY_OR_OTHER|||||||0.943||||||"P-value of  dialysis staff encouragement "|Wilcoxon signed-rank test|||||||0.943
70987975|NCT01876732|141484794|SUPERIORITY_OR_OTHER|||||||1||||||"P-value of  overall health "|Wilcoxon signed-rank test|||||||1.00
70987976|NCT01876732|141484794|SUPERIORITY_OR_OTHER|||||||0.09||||||"P-value of  patient satisfaction "|Wilcoxon signed-rank test|||||||0.090
70987977|NCT01876732|141484794|SUPERIORITY_OR_OTHER|||||||0.391||||||"P-value of  physical functioning "|Wilcoxon signed-rank test|||||||0.391
70987978|NCT01876732|141484794|SUPERIORITY_OR_OTHER|||||||0.438||||||"P-value of  role-physical "|Wilcoxon signed-rank test|||||||0.438
70987979|NCT01876732|141484794|SUPERIORITY_OR_OTHER|||||||0.424||||||"P-value of  pain "|Wilcoxon signed-rank test|||||||0.424
70987980|NCT01876732|141484794|SUPERIORITY_OR_OTHER|||||||0.169||||||"P-value of  general health "|Wilcoxon signed-rank test|||||||0.169
70987981|NCT01876732|141484794|SUPERIORITY_OR_OTHER|||||||0.858||||||"P-value of  emotional well-being "|Wilcoxon signed-rank test|||||||0.858
70987982|NCT01876732|141484794|SUPERIORITY_OR_OTHER|||||||0.156||||||"P-value of  role-emotional "|Wilcoxon signed-rank test|||||||0.156
70987983|NCT01876732|141484794|SUPERIORITY_OR_OTHER|||||||0.084||||||"P-value of  energy/fatigue "|Wilcoxon signed-rank test|||||||0.084
71038365|NCT01243151|141583768|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.82|STANDARD_ERROR_OF_MEAN|4.373|<|0.0001|TWO_SIDED|95.0|-49.58|-32.07|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-32.07|-49.58|<0.0001
71038366|NCT01243151|141583768|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.75|STANDARD_ERROR_OF_MEAN|4.464|<|0.0001|TWO_SIDED|95.0|-52.68|-34.81|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-34.81|-52.68|<0.0001
70987984|NCT01876732|141484794|SUPERIORITY_OR_OTHER|||||||0.583||||||"P-value of  SF-12 physical composite "|Wilcoxon signed-rank test|||||||0.583
70987985|NCT01876732|141484794|SUPERIORITY_OR_OTHER|||||||0.358||||||"p-value of  SF-12 mental composite "|Wilcoxon signed-rank test|||||||0.358
70987986|NCT02531373|141484799|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|-4.0|||||TWO_SIDED|95.0|-13.5|3.1||||||||3.1|-13.5|
70987987|NCT02531373|141484799|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|-6.0|||||TWO_SIDED|95.0|-16.3|1.2||||||||1.2|-16.3|
70987988|NCT02531373|141484799|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|-3.9|||||TWO_SIDED|95.0|-13.3|3.2||||||||3.2|-13.3|
70987989|NCT02531373|141484799|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|-1.9|||||TWO_SIDED|95.0|-10.2|5.1||||||||5.1|-10.2|
70987990|NCT02531373|141484800|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-6.9|7.2||||||||7.2|-6.9|
70987991|NCT02531373|141484800|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-6.9|7.2||||||||7.2|-6.9|
70987992|NCT02531373|141484800|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-6.9|7.1||||||||7.1|-6.9|
70987993|NCT02531373|141484800|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-6.9|6.9||||||||6.9|-6.9|
70987994|NCT02531373|141484801|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|20.3||||0.029|TWO_SIDED|95.0|2.1|37.3|||Miettinen and Nurminen method|||||37.3|2.1|0.029
70987995|NCT02531373|141484801|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|22.3||||0.016|TWO_SIDED|95.0|4.3|39.1|||Miettinen and Nurminen method|||||39.1|4.3|0.016
70987996|NCT02531373|141484801|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|1.1||||0.908|TWO_SIDED|95.0|-17.7|19.9|||Miettinen and Nurminen method|||||19.9|-17.7|0.908
70987997|NCT02531373|141484801|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|23.1||||0.011|TWO_SIDED|95.0|5.4|39.6|||Miettinen and Nurminen method|||||39.6|5.4|0.011
70987998|NCT02531373|141484802|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|-0.5||||0.943|TWO_SIDED|95.0|-14.0|12.9|||Miettinen and Nurminen method|||||12.9|-14.0|0.943
70987999|NCT02531373|141484802|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|-2.5||||0.711|TWO_SIDED|95.0|-16.4|11.2|||Miettinen and Nurminen method|||||11.2|-16.4|0.711
70988000|NCT02531373|141484802|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|3.7||||0.529|TWO_SIDED|95.0|-8.7|16.4|||Miettinen and Nurminen method|||||16.4|-8.7|0.529
70988001|NCT02531373|141484802|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|5.8||||0.298|TWO_SIDED|95.0|-5.8|18.2|||Miettinen and Nurminen method|||||18.2|-5.8|0.298
70988002|NCT02531373|141484803|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.61|1.1||||||Serotype 1||1.10|0.61|
70988003|NCT02531373|141484803|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|1.77|||||TWO_SIDED|95.0|1.33|2.35||||||Serotype 3||2.35|1.33|
70988004|NCT02531373|141484803|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|1.28|||||TWO_SIDED|95.0|0.91|1.81||||||Serotype 4||1.81|0.91|
71038367|NCT01243151|141583768|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.36|STANDARD_ERROR_OF_MEAN|4.437|<|0.0001|TWO_SIDED|95.0|-61.25|-43.48|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-43.48|-61.25|<0.0001
71038368|NCT01243151|141583768|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.94|STANDARD_ERROR_OF_MEAN|4.312|<|0.0001|TWO_SIDED|95.0|-58.58|-41.31|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-41.31|-58.58|<0.0001
71038369|NCT01243151|141583769|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|19.581||0.9789|TWO_SIDED|95.0|-39.08|38.04|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||38.04|-39.08|0.9789
71098469|NCT00564070|141704970|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|22.3|STANDARD_ERROR_OF_MEAN|7.0|=|0.002|TWO_SIDED|95.0|8.6|36.1|||Mixed Models Analysis|||We hypothesized that differences in glucose monitoring adherence would continue to be superior in the CBT-AD condition compared to ETAU||36.1|8.6|=.002
71098470|NCT00564070|141704971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.3|STANDARD_ERROR_OF_MEAN|5.0|=|0.001|TWO_SIDED|95.0|6.5|26.1|||Mixed Models Analysis|||We hypothesized that the CBT-AD condition would maintain higher medication adherence over follow up compared to ETAU||26.1|6.5|=.001
71098471|NCT00564070|141704972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|2.1||0.16|TWO_SIDED|95.0|-1.2|7.2|||Mixed Models Analysis|||We hypothesized that the lower depression scores would remain in the CBT arm compared to ETAU over follow up.||7.2|-1.2|.16
71098472|NCT00564070|141704973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.29||0.1|TWO_SIDED|95.0|-0.1|1.1|||Mixed Models Analysis|||We hypothesized that depression scores would remain lower in the CBT-AD arm compared to the ETAU arm||1.1|-.1|.10
71098473|NCT00564070|141704974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.29||0.03|TWO_SIDED|95.0|0.6|1.2|||Mixed Models Analysis|||We hypothesized that glucose control (HbA1C) would remain superior in the CBT-AD arm compared to the ETAU arm over follow up.||1.2|.6|.03
71098474|NCT03142334|141704989|OTHER|HR and the associated 95% CIs were calculated based on Cox Regression model and p-value was calculated based on log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.68||||0.001|TWO_SIDED|95.0|0.53|0.87|||Log Rank|One-sided p-value was based on log-rank test stratified by metastasis status, ECOG PS, US participant within M0 group by investigator.|Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastasis status, ECOG PS, and US participant within M0 group by investigator was used to calculate HR and 95% CIs.|||0.87|0.53|0.0010
70988005|NCT02531373|141484803|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.95|||||TWO_SIDED|95.0|0.59|1.51||||||Serotype 5||1.51|0.59|
70988006|NCT02531373|141484803|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.5||||||95.0|0.29|0.86||||||Serotype 6A||0.86|0.29|
70988007|NCT02531373|141484803|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.58|2.1||||||Serotype 6B||2.10|0.58|
70988008|NCT02531373|141484803|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.55|1.03||||||Serotype 7F||1.03|0.55|
70988009|NCT02531373|141484803|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.74|1.75||||||Serotype 9V||1.75|0.74|
70988010|NCT02531373|141484803|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.58|1.27||||||Serotype 14||1.27|0.58|
70988011|NCT02531373|141484803|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.63||||||95.0|0.43|0.92||||||Serotype 18C||0.92|0.43|
70988012|NCT02531373|141484803|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.64|1.26||||||Serotype 19A||1.26|0.64|
70988013|NCT02531373|141484803|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.62|1.11||||||Serotype 19F||1.11|0.62|
70988014|NCT02531373|141484803|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|81.47|||||TWO_SIDED|95.0|60.51|109.68||||||Serotype 22F (non-Prevnar serotype)||109.68|60.51|
70988015|NCT02531373|141484803|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.56|1.47||||||Serotype 23F||1.47|0.56|
70988016|NCT02531373|141484803|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|22.23|||||TWO_SIDED|95.0|11.77|41.97||||||Serotype 33F (non-Prevnar serotype)||41.97|11.77|
70988017|NCT02531373|141484803|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.68|1.23||||||Serotype 1||1.23|0.68|
70988018|NCT02531373|141484803|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|2.11|||||TWO_SIDED|95.0|1.6|2.8||||||Serotype 3||2.80|1.60|
70988019|NCT02531373|141484803|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|1.15|||||TWO_SIDED|95.0|0.82|1.62||||||Serotype 4||1.62|0.82|
70988020|NCT02531373|141484803|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.53|1.31||||||Serotype 5||1.31|0.53|
70988021|NCT02531373|141484803|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.54|||||TWO_SIDED|95.0|0.31|0.92||||||Serotype 6A||0.92|0.31|
70988022|NCT02531373|141484803|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.8|||||TWO_SIDED|95.0|0.42|1.5||||||Serotype 6B||1.50|0.42|
70988023|NCT02531373|141484803|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.71|1.31||||||Serotype 7F||1.31|0.71|
70988024|NCT02531373|141484803|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.64|1.49||||||Serotype 9V||1.49|0.64|
71038370|NCT01243151|141583769|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.94|STANDARD_ERROR_OF_MEAN|20.069||0.5525|TWO_SIDED|95.0|-51.46|27.59|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||27.59|-51.46|0.5525
70988025|NCT02531373|141484803|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.63|1.37||||||Serotype 14||1.37|0.63|
70988026|NCT02531373|141484803|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.55|1.16||||||Serotype 18C||1.16|0.55|
70988027|NCT02531373|141484803|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.63|1.22||||||Serotype 19A||1.22|0.63|
70988028|NCT02531373|141484803|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.81|1.44||||||Serotype 19F||1.44|0.81|
70988029|NCT02531373|141484803|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|89.87|||||TWO_SIDED|95.0|67.02|120.51||||||Serotype 22F (non-Prevnar serotype)||120.51|67.02|
70988030|NCT02531373|141484803|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.61|1.57||||||Serotype 23F||1.57|0.61|
70988031|NCT02531373|141484803|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|18.38|||||TWO_SIDED|95.0|9.82|34.41||||||Serotype 33F (non-Prevnar serotype)||34.41|9.82|
71098475|NCT03071965|141705001|SUPERIORITY||Median Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.0881||0.5455|TWO_SIDED|95.0|-0.226|0.12|||Mixed Models Analysis|||||0.120|-0.226|0.5455
71098476|NCT05529173|141705015|OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71098477|NCT03892915|141705071|SUPERIORITY||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.73|1.93||||||||1.93|0.73|
70988032|NCT00623467|141484828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03|STANDARD_DEVIATION|0.86|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
70988033|NCT00623467|141484828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85|STANDARD_DEVIATION|0.74|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
70988034|NCT00623467|141484828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53|STANDARD_DEVIATION|0.54|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
70988035|NCT00623467|141484829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.94|STANDARD_DEVIATION|0.8|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
70988036|NCT00623467|141484829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17|STANDARD_DEVIATION|0.94|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
70988037|NCT00623467|141484829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08|STANDARD_DEVIATION|0.74|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
70988038|NCT00623467|141484830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.93|STANDARD_DEVIATION|0.82|<|0.0001||||||for contrast enhancement|paired t-test|||||||<0.0001
70988039|NCT00623467|141484830|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.12|STANDARD_DEVIATION|0.74|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
70988040|NCT00623467|141484830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_DEVIATION|0.57|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
70988041|NCT00623467|141484831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.94|STANDARD_DEVIATION|0.77|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
70988042|NCT00623467|141484831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02|STANDARD_DEVIATION|0.71|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
70988043|NCT00623467|141484831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.78|STANDARD_DEVIATION|0.53|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
70988044|NCT00623467|141484832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66|STANDARD_DEVIATION|5.31|||||||||||for BR1|||||
70988045|NCT00623467|141484832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_DEVIATION|8.77|||||||||||for BR2|||||
70988046|NCT00623467|141484832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|STANDARD_DEVIATION|4.2|||||||||||for BR3|||||
70988047|NCT00623467|141484832|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.32|STANDARD_DEVIATION|3.53|||TWO_SIDED|95.0|-0.07|0.704|||95% confidence interval for paired means||confidence interval provided for average reader, lower limit is compared to noninferiority margin|||0.704|-0.070|
70988048|NCT00623467|141484833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89|STANDARD_DEVIATION|0.68|<|0.0001||||||for border delineation|paired t-test|||||||< 0.0001
70988049|NCT00623467|141484833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|STANDARD_DEVIATION|0.65|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
70988050|NCT00623467|141484834|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.21|STANDARD_DEVIATION|1.6||||95.0|0.03|0.381|||||lower limit of the confidence interval is compared to the noninferiority margin|||0.381|0.030|
70988051|NCT00623467|141484835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.59|STANDARD_DEVIATION|1.47|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
70988052|NCT00623467|141484835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75|STANDARD_DEVIATION|1.34|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
70988053|NCT00623467|141484835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|STANDARD_DEVIATION|1.03|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
70988054|NCT00623467|141484836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.49|STANDARD_DEVIATION|1.38|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
70988055|NCT00623467|141484836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|STANDARD_DEVIATION|1.6|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
70988056|NCT00623467|141484836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02|STANDARD_DEVIATION|1.25|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
70988057|NCT00623467|141484837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67|STANDARD_DEVIATION|1.39|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
70988058|NCT00623467|141484837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|STANDARD_DEVIATION|1.3|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
71098478|NCT03892915|141705072|SUPERIORITY||beta coefficient|5.33|STANDARD_ERROR_OF_MEAN|5.39|||TWO_SIDED|||||||||||||
70988059|NCT00623467|141484837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91|STANDARD_DEVIATION|1.02|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
70988060|NCT00623467|141484838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51|STANDARD_DEVIATION|1.32|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
70988061|NCT00623467|141484838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|1.27|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
70988062|NCT00623467|141484838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_DEVIATION|0.99|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
70988063|NCT00623467|141484839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_DEVIATION|0.48|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
70988064|NCT00623467|141484839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93|STANDARD_DEVIATION|0.46|<|0.0001||||||for border delineation|paired t test|||||||<0.0001
70988065|NCT00623467|141484839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62|STANDARD_DEVIATION|0.32|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
70988066|NCT00623467|141484840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.35|STANDARD_DEVIATION|0.4|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
70988067|NCT00623467|141484840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.27|STANDARD_DEVIATION|0.38|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
70988068|NCT00623467|141484840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17|STANDARD_DEVIATION|0.34|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
70988069|NCT00623467|141484841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.21|STANDARD_DEVIATION|0.37|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
70988070|NCT00623467|141484841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07|STANDARD_DEVIATION|0.45|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
70988071|NCT00623467|141484841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72|STANDARD_DEVIATION|0.3|<|0.0001||||||for internal morphology|paired t test|||||||<0.0001
70988072|NCT00623467|141484842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.32|STANDARD_DEVIATION|0.34|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
70988073|NCT00623467|141484842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.09|STANDARD_DEVIATION|0.3|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
70988074|NCT00623467|141484842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.84|STANDARD_DEVIATION|0.22|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
70988075|NCT00623467|141484844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|STANDARD_DEVIATION|1.0|<|0.0001||||||for border delineation|paired t-test|||||||< 0.0001
70988076|NCT00623467|141484844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66|STANDARD_DEVIATION|0.9|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
70988077|NCT00623467|141484845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99|STANDARD_DEVIATION|0.63|<|0.0001||||||for border delineation|paired t-test|||||||< 0.0001
70988078|NCT00623467|141484845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85|STANDARD_DEVIATION|0.64|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
70988079|NCT00623467|141484846|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.4||||0.0002|||||||McNemar|||||||0.0002
70988080|NCT00623467|141484847|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.3||||0.0001|||||||McNemar|||||||0.0001
70988081|NCT00623467|141484848|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.0||||0.0285|||||||McNemar|||||||0.0285
70988082|NCT00623467|141484849|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.5||||0.0004|||||||McNemar|||||||0.0004
70988083|NCT00623467|141484850|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-12.5||||0.0588|||||||McNemar|||||||0.0588
70988084|NCT00623467|141484851|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.0||||0.0093|||||||McNemar|||||||0.0093
70988085|NCT00623467|141484852|SUPERIORITY_OR_OTHER||Risk Difference (RD)|20.6||||0.0003|||||||McNemar|||||||0.0003
70988086|NCT00623467|141484853|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||1|||||||McNemar|||||||1.0000
70988087|NCT00623467|141484854|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.8||||0.0016|||||||McNemar|||||||0.0016
70988088|NCT00623467|141484855|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.9||||0.0253|||||||McNemar|||||||0.0253
70988089|NCT00623467|141484856|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.5||||0.0253|||||||McNemar|||||||0.0253
70988090|NCT00623467|141484857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_DEVIATION|0.7|<|0.0001|||||||paired t-test|||||||< 0.0001
70988091|NCT00623467|141484858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.84|STANDARD_DEVIATION|0.81|<|0.0001|||||||paired t-test|||||||< 0.0001
70988092|NCT04705597|141484870|SUPERIORITY||Odds Ratio (OR)|1.366||||0.3312|TWO_SIDED|95.0|0.728|2.562|||Regression, Logistic|||||2.562|0.728|0.3312
70988093|NCT04705597|141484872|SUPERIORITY||Odds Ratio (OR)|0.574||||0.4561|TWO_SIDED|95.0|0.133|2.475|||Regression, Logistic|||Day 14||2.475|0.133|0.4561
70988094|NCT04705597|141484872|SUPERIORITY||Odds Ratio (OR)|0.521||||0.1559|TWO_SIDED|95.0|0.212|1.282|||Regression, Logistic|||Day 28||1.282|0.212|0.1559
70988095|NCT04705597|141484872|SUPERIORITY||Odds Ratio (OR)|0.498||||0.1293|TWO_SIDED|95.0|0.203|1.226|||Regression, Logistic|||Day 57||1.226|0.203|0.1293
70988096|NCT04705597|141484873|SUPERIORITY|||||||0.2687|||||||Log Rank|||Statistical analysis was only performed for Day 28. This is timeframe used for the primary endpoint||||0.2687
70988097|NCT04705597|141484874|SUPERIORITY|||||||0.3977|||||||Log Rank|||||||0.3977
70988098|NCT04705597|141484875|SUPERIORITY|||||||0.2229|||||||Log Rank|||||||0.2229
70988099|NCT04705597|141484876|SUPERIORITY||Odds Ratio (OR)|1.388||||0.2941|TWO_SIDED|95.0|0.752|2.561|||Regression, Logistic|||||2.561|0.752|0.2941
70988100|NCT04705597|141484877|SUPERIORITY|||||||0.3325|||||||Log Rank|||||||0.3325
70988101|NCT04705597|141484878|SUPERIORITY||Mean Difference (Final Values)|0.64||||0.0254|TWO_SIDED|95.0|0.08|1.2||Change at Day 14|ANCOVA|||||1.2|0.08|0.0254
70988102|NCT04705597|141484878|SUPERIORITY||Mean Difference (Final Values)|0.53||||0.1109|TWO_SIDED|95.0|-0.12|1.18|||ANCOVA|||Change at Day 28||1.18|-0.12|0.1109
70988103|NCT04705597|141484878|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.864|TWO_SIDED|95.0|-0.1|0.12|||ANCOVA|||Change at Day 57||0.12|-0.10|0.8640
71098479|NCT03892915|141705074|SUPERIORITY||Odds Ratio (OR)|1.85|||||TWO_SIDED|95.0|0.53|6.5||||||||6.50|0.53|
70988104|NCT04705597|141484879|SUPERIORITY||Odds Ratio (OR)|2.046||||0.0919|TWO_SIDED|95.0|0.89|4.706|||Regression, Logistic|||||4.706|0.89|0.0919
70988105|NCT04705597|141484880|SUPERIORITY||Mean Difference (Final Values)|3.83||||0.749|TWO_SIDED|95.0|-0.42|8.08|||ANCOVA|||||8.08|-0.42|0.749
70988106|NCT04705597|141484881|SUPERIORITY||Mean Difference (Final Values)|3.69||||0.1769|TWO_SIDED|95.0|-1.75|9.13|||ANCOVA|||||9.13|-1.75|0.1769
70988107|NCT04705597|141484882|SUPERIORITY||Odds Ratio (OR)|0.54||||0.2621|TWO_SIDED|95.0|0.184|1.586|||Regression, Logistic|||||1.586|0.184|0.2621
70988108|NCT04705597|141484883|SUPERIORITY||Mean Difference (Final Values)|2.81||||0.2265|TWO_SIDED|95.0|-1.76|7.37|||ANCOVA|||||7.37|-1.76|0.2265
70988109|NCT04705597|141484884|SUPERIORITY||Odds Ratio (OR)|1.223||||0.5497|TWO_SIDED|95.0|0.633|2.364|||Regression, Logistic|||||2.364|0.633|0.5497
71038371|NCT01243151|141583769|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.39|STANDARD_ERROR_OF_MEAN|19.979||0.5035|TWO_SIDED|95.0|-52.73|25.96|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||25.96|-52.73|0.5035
71038372|NCT01243151|141583769|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.21|STANDARD_ERROR_OF_MEAN|19.601||0.8302|TWO_SIDED|95.0|-42.81|34.39|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||34.39|-42.81|0.8302
71098480|NCT03892915|141705075|SUPERIORITY||Odds Ratio (OR)|2.73|||||TWO_SIDED|95.0|0.45|16.64||||||||16.64|0.45|
70988110|NCT04705597|141484885|SUPERIORITY||Mean Difference (Final Values)|4.89||||0.1172|TWO_SIDED|95.0|-1.27|11.05|||ANCOVA|||||11.05|-1.27|0.1172
71098481|NCT03892915|141705076|SUPERIORITY||Odds Ratio (OR)|0.2|||||TWO_SIDED|95.0|0.05|0.83||||||||0.83|0.05|
71098482|NCT01181128|141705082|SUPERIORITY_OR_OTHER_LEGACY||Bleeding Rate Ratio|0.08|||<|0.001|TWO_SIDED|95.0|0.05|0.13|||negative binomial model|||The null hypothesis for the primary endpoint is no difference between the individualized (tailored) prophylaxis regimen and the on-demand regimen. The sample size of this study was mainly based on clinical rather than statistical considerations. However it was projected to have \> 90% power at the 2-sided 0.05 level of significance to detect a 60% reduction in annualized bleeding episodes, based upon this hypothesis test.||0.13|0.05|<0.001
70988111|NCT04705597|141484886|SUPERIORITY||Odds Ratio (OR)|0.914||||0.853|TWO_SIDED|95.0|0.353|2.368|||Regression, Logistic|||||2.368|0.353|0.853
70988112|NCT04705597|141484887|SUPERIORITY||Mean Difference (Final Values)|3.16||||0.1991|TWO_SIDED|95.0|-1.86|8.18|||ANCOVA|||||8.18|-1.86|0.1991
70988113|NCT04705597|141484888|SUPERIORITY||Odds Ratio (OR)|4.103||||0.0166|TWO_SIDED|95.0|1.293|13.027|||Regression, Logistic|||||13.027|1.293|0.0166
70988114|NCT04705597|141484889|SUPERIORITY||Mean Difference (Final Values)|4.56||||0.1297|TWO_SIDED|95.0|-1.51|10.64|||ANCOVA|||||10.64|-1.51|0.1297
70988115|NCT04705597|141484890|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.1916|TWO_SIDED|95.0|-0.35|0.07|||ANCOVA|||Baseline||0.07|-0.35|0.1916
70988116|NCT04705597|141484890|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.1097|TWO_SIDED|95.0|-0.44|0.05|||ANCOVA|||Treatment Day 2||0.05|-0.44|0.1097
70988117|NCT04705597|141484890|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.0276|TWO_SIDED|95.0|-0.63|-0.04|||ANCOVA|||Treatment Day 3||-0.04|-0.63|0.0276
70988118|NCT04705597|141484890|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.0463|TWO_SIDED|95.0|-0.71|-0.01|||ANCOVA|||Treatment Day 4||-0.01|-0.71|0.0463
70988119|NCT04705597|141484890|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.0969|TWO_SIDED|95.0|-0.71|0.06|||ANCOVA|||Treatment Day 5||0.06|-0.71|0.0969
70988120|NCT04705597|141484890|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.4367|TWO_SIDED|95.0|-0.57|0.25|||ANCOVA|||Treatment Day 6||0.25|-0.57|0.4367
70988121|NCT04705597|141484890|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.6685|TWO_SIDED|95.0|-0.54|0.35|||ANCOVA|||Treatment Day 7||0.35|-0.54|0.6685
70988122|NCT04705597|141484890|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.2287|TWO_SIDED|95.0|-0.73|0.18|||ANCOVA|||Treatment Day 8||0.18|-0.73|0.2287
70988123|NCT04705597|141484890|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.1061|TWO_SIDED|95.0|-0.96|0.09|||ANCOVA|||Treatment Day 9||0.09|-0.96|0.1061
70988124|NCT04705597|141484890|SUPERIORITY||Mean Difference (Final Values)|-0.54||||0.0415|TWO_SIDED|95.0|-1.06|-0.02|||ANCOVA|||Treatment Day 10||-0.02|-1.06|0.0415
70988125|NCT04705597|141484890|SUPERIORITY||Mean Difference (Final Values)|-0.44||||0.1236|TWO_SIDED|95.0|-1.0|0.12|||ANCOVA|||Treatment Day 11||0.12|-1.00|0.1236
70988126|NCT04705597|141484890|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.0097|TWO_SIDED|95.0|-1.23|-0.18|||ANCOVA|||Treatment Day 12||-0.18|-1.23|0.0097
70988127|NCT04705597|141484890|SUPERIORITY||Mean Difference (Final Values)|-0.57||||0.0157|TWO_SIDED|95.0|-1.02|-0.11|||ANCOVA|||Treatment Day 13||-0.11|-1.02|0.0157
70988128|NCT04705597|141484890|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.001|TWO_SIDED|95.0|-1.32|-0.36|||ANCOVA|||Treatment Day 14||-0.36|-1.32|0.0010
70988129|NCT04705597|141484890|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.644|TWO_SIDED|95.0|-0.4|0.25|||ANCOVA|||Time of Discharge Visit||0.25|-0.40|0.6440
70988130|NCT04705597|141484890|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9869|TWO_SIDED|95.0|-0.6|0.59|||ANCOVA|||Follow up Day 28||0.59|-0.60|0.9869
70988131|NCT04705597|141484891|SUPERIORITY||Mean Difference (Final Values)|1.69||||0.2399|TWO_SIDED|95.0|-1.14|4.52|||ANCOVA|||||4.52|-1.14|0.2399
70988132|NCT04705597|141484892|SUPERIORITY||Odds Ratio (OR)|0.869||||0.8081|TWO_SIDED|95.0|0.28|2.695|||Regression, Logistic|||||2.695|0.28|0.8081
70988133|NCT04705597|141484893|SUPERIORITY||Odds Ratio (OR)|1.436||||0.3193|TWO_SIDED|95.0|0.704|2.929|||Regression, Logistic|||||2.929|0.704|0.3193
70988134|NCT01035606|141484924|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<.01
70988135|NCT01035606|141484925|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<.01
70988136|NCT01809262|141484926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.02||0.0005||95.0|0.031|0.109|||ANCOVA|||||0.109|0.031|0.0005
70988137|NCT01809262|141484926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.06|0.138|||ANCOVA|||||0.138|0.060|<0.0001
71098483|NCT01181128|141705088|SUPERIORITY_OR_OTHER_LEGACY||Bleeding Rate Ratio|0.24|||<|0.001|TWO_SIDED|95.0|0.12|0.46|||negative binomial model|||||0.46|0.12|<0.001
71038373|NCT01243151|141583769|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.45|STANDARD_ERROR_OF_MEAN|19.581||0.559|TWO_SIDED|95.0|-50.01|27.1|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||27.10|-50.01|0.5590
71038374|NCT01243151|141583769|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.84|STANDARD_ERROR_OF_MEAN|20.069||0.5558|TWO_SIDED|95.0|-51.36|27.69|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||27.69|-51.36|0.5558
71098484|NCT00395512|141705135|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.56|||<|0.001|TWO_SIDED|95.0|-0.78|-0.33||ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.|ANCOVA|||The primary efficacy variable was defined as change from Baseline in HbA1c level at Week 26. The null hypothesis was that the average change from Baseline in HbA1c at Week 26 for the A25 + P30 group would be equal to the average changes for the P30 alone and A25 alone groups; further, under the null hypothesis, the average change from Baseline in HbA1c at Week 26 for the A12.5 + P30 group was equal to the average change for the P30 alone group.||-0.33|-0.78|<0.001
70988138|NCT01809262|141484926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.074|0.152|||ANCOVA|||||0.152|0.074|<0.0001
70988139|NCT01809262|141484926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.08|0.158|||ANCOVA|||||0.158|0.080|<0.0001
70988140|NCT01809262|141484927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.077|0.139|||ANCOVA|||||0.139|0.077|<0.0001
70988141|NCT01809262|141484927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.124|0.186|||ANCOVA|||||0.186|0.124|<0.0001
70988142|NCT01809262|141484927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.13|0.192|||ANCOVA|||||0.192|0.130|<0.0001
70988143|NCT01809262|141484927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.161|0.223|||ANCOVA|||||0.223|0.161|<0.0001
70988144|NCT01809262|141484928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.068|0.131|||ANCOVA|||||0.131|0.068|<0.0001
71038375|NCT01243151|141583769|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|20.332||0.6835|TWO_SIDED|95.0|-48.34|31.74|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||31.74|-48.34|0.6835
71038376|NCT01243151|141583769|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.15|STANDARD_ERROR_OF_MEAN|19.601||0.5699|TWO_SIDED|95.0|-49.75|27.45|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||27.45|-49.75|0.5699
71098485|NCT00395512|141705135|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-0.98|-0.53||ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.|ANCOVA|||||-0.53|-0.98|<0.001
71098486|NCT00395512|141705135|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-0.63|-0.18||ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.|ANCOVA|||||-0.18|-0.63|<0.001
70988145|NCT01809262|141484928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.107|0.171|||ANCOVA|||||0.171|0.107|<0.0001
70988146|NCT01809262|141484928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.153|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.122|0.185|||ANCOVA|||||0.185|0.122|<0.0001
70988147|NCT01809262|141484928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.152|0.215|||ANCOVA|||||0.215|0.152|<0.0001
70988148|NCT01809262|141484929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001||95.0|0.056|0.117|||ANCOVA|||||0.117|0.056|<0.0001
70988149|NCT01809262|141484929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001||95.0|0.087|0.148|||ANCOVA|||||0.148|0.087|<0.0001
70988150|NCT01809262|141484929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001||95.0|0.107|0.168|||ANCOVA|||||0.168|0.107|<0.0001
70988151|NCT01809262|141484929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001||95.0|0.132|0.193|||ANCOVA|||||0.193|0.132|<0.0001
70988152|NCT01809262|141484930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.074|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.041|0.108|||ANCOVA|||||0.108|0.041|<0.0001
70988153|NCT01809262|141484930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.096|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.062|0.13|||ANCOVA|||||0.130|0.062|<0.0001
70988154|NCT01809262|141484930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.122|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.089|0.156|||ANCOVA|||||0.156|0.089|<0.0001
70988155|NCT01809262|141484930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.107|0.174|||ANCOVA|||||0.174|0.107|<0.0001
70988156|NCT01809262|141484931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.084|0.158|||ANCOVA|||||0.158|0.084|<0.0001
70988157|NCT01809262|141484931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.129|0.203|||ANCOVA|||||0.203|0.129|<0.0001
70988158|NCT01809262|141484931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.139|0.214|||ANCOVA|||||0.214|0.139|<0.0001
70988159|NCT01809262|141484931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.176|0.25|||ANCOVA|||||0.250|0.176|<0.0001
70988160|NCT01809262|141484932|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.306|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001||95.0|0.21|0.402|||ANCOVA|||||0.402|0.210|<0.0001
70988161|NCT01809262|141484932|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.355|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001||95.0|0.258|0.452|||ANCOVA|||||0.452|0.258|<0.0001
70988162|NCT01809262|141484932|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001||95.0|0.253|0.447|||ANCOVA|||||0.447|0.253|<0.0001
70988163|NCT01809262|141484932|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.455|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001||95.0|0.359|0.551|||ANCOVA|||||0.551|0.359|<0.0001
70988164|NCT02064439|141484940|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.34||||0.0001|TWO_SIDED|95.0|0.2|0.59||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||0.59|0.20|0.0001
70988165|NCT02064439|141484940|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26|||<|0.0001|TWO_SIDED|98.0|0.14|0.47||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||0.47|0.14|<0.0001
70988166|NCT02064439|141484940|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.34||||0.4328|TWO_SIDED|95.0|0.65|2.75||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||2.75|0.65|0.4328
70988167|NCT02064439|141484941|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.01||||0.3235|TWO_SIDED|95.0|0.5|8.04||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||8.04|0.50|0.3235
70988168|NCT02064439|141484941|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.64||||0.5005|TWO_SIDED|95.0|0.39|6.84||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||6.84|0.39|0.5005
70988169|NCT02064439|141484941|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.7337|TWO_SIDED|95.0|0.37|4.03||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||4.03|0.37|0.7337
70988170|NCT02064439|141484942|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.34|||<|0.0001|TWO_SIDED|95.0|0.2|0.57||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||0.57|0.20|<0.0001
70988171|NCT02064439|141484942|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.32|||<|0.0001|TWO_SIDED|95.0|0.19|0.54||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||0.54|0.19|<0.0001
70988172|NCT02064439|141484942|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.8172|TWO_SIDED|95.0|0.57|2.06||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||2.06|0.57|0.8172
70988173|NCT02064439|141484943|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.44||||0.3318|TWO_SIDED|95.0|0.69|3.02||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||||3.02|0.69|0.3318
70988174|NCT02064439|141484943|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.9726|TWO_SIDED|95.0|0.44|2.2||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||||2.20|0.44|0.9726
70988175|NCT02064439|141484943|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.46||||0.3137|TWO_SIDED|95.0|0.7|3.06||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||||3.06|0.70|0.3137
70988176|NCT00385268|141484962|SUPERIORITY||Odds Ratio (OR)|1.68||||0.44|TWO_SIDED|95.0|0.55|5.14|||GEE model of repeated measures|GEE on repeated binary indicators of BE positive / negative test||||5.14|0.55|0.44
70988177|NCT02389816|141484963|SUPERIORITY||Least square (LS) mean difference|-2.66|STANDARD_ERROR_OF_MEAN|0.999||0.008|TWO_SIDED|95.0|-4.63|-0.7|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||||-0.70|-4.63|0.0080
70988178|NCT02389816|141484963|SUPERIORITY||LS mean difference|-3.07|STANDARD_ERROR_OF_MEAN|1.003||0.0023|TWO_SIDED|95.0|-5.05|-1.1|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||||-1.10|-5.05|0.0023
70988179|NCT02389816|141484964|SUPERIORITY||Odds Ratio (OR)|1.621||||0.0341|TWO_SIDED|95.0|1.037|2.533|||Regression, Logistic|||||2.533|1.037|0.0341
70988180|NCT02389816|141484964|SUPERIORITY||Odds Ratio (OR)|1.788||||0.011||95.0|1.143|2.799|||Regression, Logistic|||||2.799|1.143|0.0110
70988181|NCT02389816|141484965|SUPERIORITY||Odds Ratio (OR)|1.839||||0.0186|TWO_SIDED|95.0|1.107|3.054|||Regression, Logistic|||||3.054|1.107|0.0186
70988182|NCT02389816|141484965|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0418|TWO_SIDED|95.0|1.02|2.834|||Regression, Logistic|||||2.834|1.020|0.0418
70988183|NCT02389816|141484966|SUPERIORITY||LS mean difference|-1.81|STANDARD_ERROR_OF_MEAN|0.753||0.0165|TWO_SIDED|95.0|-3.29|-0.332|||ANCOVA|||||-0.332|-3.290|0.0165
71098487|NCT00395512|141705136|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.33||||0.003|TWO_SIDED|95.0|-0.55|-0.12|||ANCOVA|ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.||Comparison of change from Baseline at Week 20 between Pioglitazone 30 mg and Alogliptin 12.5 mg + Pioglitazone 30 mg.||-0.12|-0.55|0.003
71098488|NCT00395512|141705136|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.74|-0.3|||ANCOVA|ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.||Comparison of change from Baseline at Week 20 between Pioglitazone 30 mg and Alogliptin 25 mg + Pioglitazone 30 mg.||-0.30|-0.74|<0.001
71098489|NCT00395512|141705136|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.73|||<|0.001|TWO_SIDED|95.0|-0.94|-0.51|||ANCOVA|ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.||Comparison of change from Baseline at Week 20 between Alogliptin 25 mg and Alogliptin 25 mg + Pioglitazone 30 mg.||-0.51|-0.94|<0.001
71098490|NCT00395512|141705137|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.2||||0.017|TWO_SIDED|95.0|-20.3|-2.0|||ANCOVA|P-value is from an ANCOVA model with treatment and geographic region as class variables and Baseline fasting plasma glucose as covariate.||Comparison of change from Baseline in fasting plasma glucose at Week 26 between Pioglitazone 30 mg and Alogliptin 12.5 mg + Pioglitazone 30 mg.||-2.0|-20.3|0.017
71098491|NCT00395512|141705137|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.9||||0.006|TWO_SIDED|95.0|-22.0|-3.8|||ANCOVA|P-value is from an ANCOVA model with treatment and geographic region as class variables and Baseline fasting plasma glucose as covariate.||Comparison of change from Baseline in fasting plasma glucose at Week 26 between Pioglitazone 30 mg and Alogliptin 25 mg + Pioglitazone 30 mg.||-3.8|-22.0|0.006
71098492|NCT00395512|141705137|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.5|||<|0.001|TWO_SIDED|95.0|-33.5|-15.4|||ANCOVA|P-value is from an ANCOVA model with treatment and geographic region as class variables and Baseline fasting plasma glucose as covariate.||Comparison of change from Baseline in fasting plasma glucose at Week 26 between Alogliptin 25 mg and Alogliptin 25 mg + Pioglitazone 30 mg.||-15.4|-33.5|<0.001
71098493|NCT00185900|141705176|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
71098494|NCT00754559|141705182|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Exact Binomial Test|||Null hypothesis: Proportion of participants reaching LDAS (≤ 3.2) at Week 24 equals (=) expected proportion of 42%.||||<0.001
71098495|NCT04913675|141705256|NON_INFERIORITY|This outcome measure was analyzed using a hypothetical estimand and assessing non-inferiority of 500 mg IM dose versus 500 mg IV using a non-inferiority margin of 3.5 percent (%) on the risk difference scale. A post-hoc weekly imputation algorithm imputes the missing outcome iteratively for each week, where missing outcomes at Day 8, 15, 22, 29 are imputed.|Risk Difference (RD)|1.06|||||TWO_SIDED|95.0|-1.15|3.26|||||Analysis was performed using a binomial regression model with identity link function and with treatment (Sotrovimab 500mg IM, 500mg IV), age (\<65, =\>65 years old) and gender (male, female) as covariates.|||3.26|-1.15|
71098496|NCT04913675|141705256|NON_INFERIORITY|This outcome measure was analyzed using a hypothetical estimand and assessing non-inferiority of 500 mg IM vs 500 mg IV using a non-inferiority margin of 3.5 percent (%) on the risk difference scale. A pre-specified daily imputation algorithm imputed the missing outcome iteratively for each study day starting with Day 2 and ending at Day 29.|Risk Difference (RD)|1.16|||||TWO_SIDED|95.0|-1.23|3.56|||||Analysis was performed using a binomial regression model with identity link function and with treatment (Sotrovimab 500mg IM, 500mg IV), age (\<65, =\>65 years old) and gender (male, female) as covariates.|||3.56|-1.23|
70988184|NCT02389816|141484966|SUPERIORITY||LS mean difference|-1.79|STANDARD_ERROR_OF_MEAN|0.759||0.019|TWO_SIDED|95.0|-3.278|-0.295|||ANCOVA|||||-0.295|-3.278|0.0190
70988185|NCT02389816|141484967|SUPERIORITY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.12||0.0031|TWO_SIDED|95.0|-0.59|-0.121|||ANCOVA|||||-0.121|-0.590|0.0031
71098497|NCT04913675|141705274|NON_INFERIORITY|This outcome measure was analyzed using a hypothetical estimand and assessing non-inferiority of IM dose versus IV using a non-inferiority margin of 3.5% on the risk difference scale. Weekly imputation algorithm imputes the missing outcome iteratively for each week, where missing outcomes at Day 8, 15, 22, 29 are imputed.|Risk Difference (RD)|0.86|||||TWO_SIDED|95.0|-1.56|3.28|||||Post-hoc analysis was performed using a binomial regression model with identify link function and with treatment (Sotrovimab 500 mg IM, 500 mg IV), age (\<65, \>-65 years old), and sex (male, female) as covariates.|||3.28|-1.56|
71098498|NCT04913675|141705277|EQUIVALENCE|IM dose was assessed for equivalence to IV based on the two-sided 90% confidence interval for the treatment ratio falling within equivalence bounds of 0.5 to 2.0.|Ratio of least square(LS) geometric mean|1.04|||||TWO_SIDED|90.0|1.0|1.07|||||LS geometric mean was calculated for 500mg IV versus IM by using an Analysis of Covariance (ANCOVA) Model with treatment group (sotrovimab 500mg IM, 500mg IV), age (\<65, =\>65 years old), gender (male, female) and Baseline viral load as covariates.|||1.07|1.00|
71098499|NCT05181657|141705313|OTHER|The intervention effect was determined via a two sided, 0.05 level of significance, multivariable Poisson regression model, with Intervention group as the primary predictor.|Risk Ratio (RR)|1.45|||<|0.05|TWO_SIDED|95.0|1.18|1.78||"Alpha significance levels used:~For the primary predictor (i.e., intervention group): alpha=0.05; For covariates: alpha=0.10; For interactions: alpha=0.15"|Poisson Regression||The estimate refers to the relative risk of getting a COVID-19 test onsite (Intervention/Control). Also, the above estimate is from the unadjusted Poisson regression model (i.e., model not adjusted for covariates and interactions).|To assess whether the active intervention was more successful than the control condition at increasing COVID-19 testing, we used univariable and multivariable Poisson regression models, with whether one received onsite testing right after the intervention as the outcome and intervention group as the main predictor. Potential clustering due to the randomization by week was accounted for by specifying an exchangeable correlation structure for participants who were recruited during the same week.||1.78|1.18|<0.05
71098500|NCT01348490|141705315|OTHER|1-sample t-test with null hypothesis mean \>= 0||||||0.025||||||1-sample t-test was used.|t-test, 1 sided|||||||0.0250
71098501|NCT01348490|141705315|OTHER|1-sample t-test with null hypothesis mean \>= 0||||||0.0163||||||1-sample t-test was used.|t-test, 1 sided|||||||0.0163
71098502|NCT01348490|141705315|OTHER|1-sample t-test with null hypothesis mean \>= 0|||||<|0.0001||||||1-sample t-test was used.|t-test, 1 sided|||||||<0.0001
71098503|NCT01348490|141705315|OTHER|1-sample t-test with null hypothesis mean \>= 0||||||0.2019||||||1-sample t-test was used.|t-test, 1 sided|||||||0.2019
71098504|NCT01348490|141705316|OTHER|||||||0.6887||||||1-sample t-test was used.|t-test, 1 sided|||||||0.6887
70988186|NCT02389816|141484967|SUPERIORITY||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.12||0.0011|TWO_SIDED|95.0|-0.629|-0.158|||ANCOVA|||||-0.158|-0.629|0.0011
70988187|NCT02389816|141484968|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.123||0.0609|TWO_SIDED|95.0|-0.474|0.011|||ANCOVA|||||0.011|-0.474|0.0609
70988188|NCT02389816|141484968|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.124||0.0179|TWO_SIDED|95.0|-0.537|-0.051|||ANCOVA|||||-0.051|-0.537|0.0179
70988189|NCT02389816|141484969|SUPERIORITY||LS mean difference|-1.34|STANDARD_ERROR_OF_MEAN|0.621||0.0311|TWO_SIDED|95.0|-2.564|-0.122|||ANCOVA|||||-0.122|-2.564|0.0311
70988190|NCT02389816|141484969|SUPERIORITY||LS mean difference|-1.57|STANDARD_ERROR_OF_MEAN|0.628||0.0126|TWO_SIDED|95.0|-2.807|-0.339|||ANCOVA|||||-0.339|-2.807|0.0126
70988191|NCT02389816|141484970|SUPERIORITY||LS mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.893||0.3793|TWO_SIDED|95.0|-2.539|0.968|||ANCOVA|||||0.968|-2.539|0.3793
71098505|NCT01348490|141705316|OTHER||||||<|0.0001||||||1-sample t-test was used.|t-test, 1 sided|||||||<0.0001
70988192|NCT02389816|141484970|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.891||0.9011|TWO_SIDED|95.0|-1.862|1.641|||ANCOVA|||||1.641|-1.862|0.9011
70988193|NCT02389816|141484971|SUPERIORITY||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.329||0.0089|TWO_SIDED|95.0|-1.512|-0.218|||ANCOVA|||||-0.218|-1.512|0.0089
70988194|NCT02389816|141484971|SUPERIORITY||LS mean difference|-1.27|STANDARD_ERROR_OF_MEAN|0.332||0.0001|TWO_SIDED|95.0|-1.922|-0.619|||ANCOVA|||||-0.619|-1.922|0.0001
70988195|NCT02417233|141484972|OTHER||Odds Ratio (OR)|0.958||||0.848|TWO_SIDED|95.0|0.62|1.49|||Regression, Logistic|||||1.49|0.62|0.848
70988196|NCT02417233|141484972|OTHER||Odds Ratio (OR)|1.492||||0.125|TWO_SIDED|95.0|0.9|2.49|||Regression, Logistic|||||2.49|0.90|0.125
70988197|NCT02417233|141484973|OTHER||Odds Ratio (OR)|0.866||||0.636|TWO_SIDED|96.0|0.48|1.57|||Regression, Logistic|||||1.57|0.48|0.636
70988198|NCT02417233|141484973|OTHER||Odds Ratio (OR)|1.401||||0.165|TWO_SIDED|95.0|0.87|2.26|||Regression, Logistic|||||2.26|0.87|0.165
70988199|NCT02417233|141484974|OTHER||Odds Ratio (OR)|1.48||||0.16|TWO_SIDED|95.0|0.86|2.55|||Regression, Logistic|||||2.55|0.86|0.16
70988200|NCT02417233|141484974|OTHER||Odds Ratio (OR)|1.82||||0.03|TWO_SIDED|95.0|1.06|3.14|||Regression, Logistic|||||3.14|1.06|0.03
70988201|NCT02417233|141484975|OTHER||Odds Ratio (OR)|0.27||||0.24|TWO_SIDED|95.0|0.03|2.45|||Regression, Logistic|||||2.45|0.03|0.24
70988202|NCT02417233|141484975|OTHER||Odds Ratio (OR)|2.68||||0.2|TWO_SIDED|95.0|0.59|12.16|||Regression, Logistic|||||12.16|0.59|0.20
70988203|NCT02417233|141484976|OTHER||Odds Ratio (OR)|1.943||||0.093|TWO_SIDED|95.0|0.9|4.21|||Regression, Logistic|||||4.21|0.90|0.093
70988204|NCT02417233|141484976|OTHER||Odds Ratio (OR)|1.764||||0.152|TWO_SIDED|95.0|0.81|3.83|||Regression, Logistic|||||3.83|0.81|0.152
70988205|NCT02262039|141484999|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70988206|NCT02262039|141485000|SUPERIORITY_OR_OTHER|||||||0.92|||||||t-test, 2 sided|||||||0.92
70988207|NCT02262039|141485001|SUPERIORITY_OR_OTHER|||||||0.78|||||||t-test, 2 sided|||||||0.78
70988208|NCT02262039|141485002|SUPERIORITY_OR_OTHER|||||||0.52|||||||t-test, 2 sided|||||||0.52
70988209|NCT02262039|141485003|SUPERIORITY_OR_OTHER|||||||0.25|||||||t-test, 2 sided|||||||0.25
70988210|NCT02262039|141485004|SUPERIORITY_OR_OTHER|||||||0.82|||||||t-test, 2 sided|||||||0.82
70988211|NCT02262039|141485005|SUPERIORITY_OR_OTHER|||||||0.45|||||||t-test, 2 sided|||||||0.45
70988212|NCT04174638|141485006|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05. The p value was the value of the total score of the Fluid Control in Hemodialysis Patients Scale.|t-test, 2 sided|||||||<0.001
70988213|NCT04174638|141485007|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||||||<0.001
70988214|NCT04174638|141485008|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||It was calculated for detect of difference in mean the knowledge sub-dimension score of Modified Morisky Scale between intervention and control group from baseline to week 12.||||<0.001
70988215|NCT04174638|141485008|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||It was calculated for detect of difference in mean the motivation sub-dimension score of Modified Morisky Scale between intervention and control group from baseline to week 12.||||<0.001
70988216|NCT04174638|141485012|SUPERIORITY|||||||0.297||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||It was calculated for detect of difference in mean the physical functions sub-dimension score of Kidney Disease Quality of Life Instrument 36 Scale between intervention and control group from baseline to week 12.||||0.297
70988217|NCT04174638|141485012|SUPERIORITY|||||||0.742||||||The threshold for statistical significance was p=0.05|t-test, 2 sided|||It was calculated for detect of difference in mean the mental functions sub-dimension score of Kidney Disease Quality of Life Instrument 36 Scale between intervention and control group from baseline to week 12.||||0.742
70988218|NCT04174638|141485012|SUPERIORITY|||||||0.719||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||It was calculated for detect of difference in mean the burden of kidney disease sub-dimension score of Kidney Disease Quality of Life Instrument 36 Scale between intervention and control group from baseline to week 12.||||0.719
70988219|NCT04174638|141485012|SUPERIORITY|||||||0.063||||||The threshold for statistical significance was p=0.05|t-test, 2 sided|||It was calculated for detect of difference in mean the symptoms/problems sub-dimension score of Kidney Disease Quality of Life Instrument 36 Scale between intervention and control group from baseline to week 12.||||0.063
70988220|NCT04174638|141485012|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||It was calculated for detect of difference in mean the effects of kidney disease on daily life sub-dimension score of Kidney Disease Quality of Life Instrument 36 Scale between intervention and control group from baseline to week 12.||||<0.001
71098506|NCT01348490|141705316|OTHER|||||||0.8701||||||1-sample t-test was used.|t-test, 1 sided|||||||0.8701
71098507|NCT01348490|141705320|OTHER||||||<|0.0001||||||1-sample t-test was used.|t-test, 1 sided|||||||<0.0001
71098508|NCT01348490|141705321|OTHER|||||||0.0028||||||1-sample t-test was used.|t-test, 1 sided|||||||0.0028
70988221|NCT00321984|141485017|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
70988222|NCT00321984|141485017|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
71098509|NCT01117350|141705329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.54||||0.439|TWO_SIDED|95.0|-3.88|8.93||"If superiority not demonstrated, switching from superiority to non-inferiority considered.~Conclusion of non-inferiority reached if lower limit of 2-sided 95% confidence interval of the difference (insulin glargine - liraglutide) \> or = to - 3.5%"|Chi-squared|||"Superiority testing~H0: Rate measured with insulin glargine = rate measured with liraglutide~H1: Rate measured with insulin glargine ≠ rate measured with liraglutide~Sample size calculation (465 randomized patients per arm) was based on the assumption of an expected success rate of 46% with insulin glargine and 35% with liraglutide, an alpha risk of 5% (2-sided) and a power of 90%, taking into account an estimated non evaluability rate of 10%."||8.93|-3.88|0.439
71098510|NCT03389750|141705346|EQUIVALENCE|An F-test was used to assess for significant differences among the 13 dose conditions.||||||0.0001|||||||ANOVA|F = 7.06 (DF=12)||||||.0001
71098511|NCT01027754|141705362|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||Fisher Exact|||||||0.03
71098512|NCT01027754|141705363|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|||||||Fisher Exact|||||||0.24
71098513|NCT01027754|141705372|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
71098514|NCT03280615|141705381|SUPERIORITY|||||||0.257|||||||Fisher Exact|||A Fisher exact test was performed||||0.257
71098515|NCT03280615|141705382|SUPERIORITY|||||||0.231|||||||Fisher Exact|||A mixed linear regression model for repeated measures was performed to test if the outcome behaved differently in both treatment groups||||0.231
71098516|NCT03280615|141705383|SUPERIORITY|||||||0.043|||||||Mixed Models Analysis|||A mixed linear regression model for repeated measures was performed to test if the outcome behaved differently in both treatment groups||||0.043
70988223|NCT00321984|141485017|SUPERIORITY_OR_OTHER|||||||0.72941||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.72941
70988224|NCT00321984|141485019|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
70988225|NCT00321984|141485019|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
70988226|NCT00321984|141485019|SUPERIORITY_OR_OTHER|||||||0.3146||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.31460
71098517|NCT02683954|141705384|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality of numerical data distribution was examined by the Shapiro-Wilk. Normally distributed numerical variables were presented as mean±SD and inter-group differences were compared using unpaired t test. Skewed numerical variables were presented as median and interquartile range and between-group differences were compared using Mann-Whitney U test. Ordinal data were compared using the chi-squared test for trend. Correlations among numerical variables were tested by Spearman rank correlation.||||0.05
71098518|NCT01755156|141705388|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.55|||<|0.001|TWO_SIDED|95.0|-0.75|-0.34|||cLDA|Based on a cLDA method with a restriction of the same baseline mean.||||-0.34|-0.75|<0.001
71098519|NCT01755156|141705389|SUPERIORITY_OR_OTHER||Difference in %|0.5|||||TWO_SIDED|95.0|-8.8|9.8|||||Based on Miettinen \& Nurminen method. The 95% CI was computed only for those endpoints with at least 4 participants having events in 1 or more treatment groups.|||9.8|-8.8|
71098520|NCT01755156|141705390|SUPERIORITY_OR_OTHER||Difference in %|-2.5|||||TWO_SIDED|95.0|-6.6|1.1|||||Based on Miettinen \& Nurminen method. The 95% CI was computed only for those endpoints with at least 4 participants having events in 1 or more treatment groups.|||1.1|-6.6|
71098521|NCT01755156|141705391|SUPERIORITY_OR_OTHER||Difference in %|4.5|||||TWO_SIDED|95.0|-3.3|12.3||||||||12.3|-3.3|
71098522|NCT01755156|141705392|SUPERIORITY_OR_OTHER||Difference in %|-14.5||||0.011|TWO_SIDED|95.0|-25.6|-3.4|||cLDA|Based on a cLDA method with a restriction of the same baseline mean.||||-3.4|-25.6|0.011
71098523|NCT01755156|141705393|SUPERIORITY_OR_OTHER||Difference in least squares means|-9.5||||0.01|TWO_SIDED|95.0|-16.7|-2.3|||cLDA|Based on a cLDA method with a restriction of the same baseline mean.||||-2.3|-16.7|0.010
71098524|NCT01755156|141705396|SUPERIORITY_OR_OTHER||Between-group rate difference (%)|19.2|||<|0.001|TWO_SIDED|95.0|10.1|28.0|||Miettinen & Nurminen method|||||28.0|10.1|<0.001
71098525|NCT01755156|141705397|SUPERIORITY_OR_OTHER||Between-group rate difference (%)|4.2||||0.164|TWO_SIDED|95.0|-1.8|10.5|||Miettinen & Nurminen method|||||10.5|-1.8|0.164
71098526|NCT01755156|141705400|SUPERIORITY_OR_OTHER||Difference in least squares means|-27.8||||0.001|TWO_SIDED|95.0|-44.8|-10.8|||cLDA|Based on a cLDA method with a restriction of the same baseline mean.||||-10.8|-44.8|0.001
71098527|NCT01755156|141705401|SUPERIORITY_OR_OTHER||Difference in least squares means|3.7||||0.025|TWO_SIDED|95.0|0.5|6.9|||cLDA|Based on a cLDA method with a restriction of the same baseline mean.||||6.9|0.5|0.025
71098528|NCT01755156|141705403|SUPERIORITY_OR_OTHER||Kaplan-Meier difference %|-1.2||||0.654|TWO_SIDED|95.0|-7.0|4.7|||Log Rank|||||4.7|-7.0|0.654
71098529|NCT00090402|141705407|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|95.0|||||Regression, Linear|Adjusted for age and body mass index||||||0.83
71098530|NCT00292370|141705435|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71098531|NCT01133977|141705470|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.23|0.75||||||The current study was not powered or designed to determine superiority of the '20 mg Lenvatinib + Dacarbazine (Phase 2)' arm compared with 'Dacarbazine (Phase 2) ' arm.||0.75|0.23|
70988227|NCT02985450|141485046|OTHER||Mean Difference (Final Values)|513.5|STANDARD_DEVIATION|73.6||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Anti-HBs levels difference: high risk obesity group - low risk obesity group NAFLD patients|||||0.02
70988228|NCT00431847|141485056|SUPERIORITY_OR_OTHER||Slope|-0.0323|STANDARD_ERROR_OF_MEAN|0.00619|<|0.0001|TWO_SIDED|95.0|-0.0448|-0.02013|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.02013|-0.0448|<0.0001
70988229|NCT00431847|141485056|SUPERIORITY_OR_OTHER||Chi Squared|2.65||||0.4492|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.4492
71038377|NCT01243151|141583769|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.42|STANDARD_ERROR_OF_MEAN|19.918||0.3826|TWO_SIDED|95.0|-56.64|21.8|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||21.80|-56.64|0.3826
71038378|NCT01243151|141583769|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.83|STANDARD_ERROR_OF_MEAN|20.069||0.5233|TWO_SIDED|95.0|-52.35|26.7|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||26.70|-52.35|0.5233
71038379|NCT01243151|141583769|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.47|STANDARD_ERROR_OF_MEAN|20.332||0.3391|TWO_SIDED|95.0|-59.51|20.57|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||20.57|-59.51|0.3391
71038380|NCT01243151|141583769|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.95|STANDARD_ERROR_OF_MEAN|19.601||0.3606|TWO_SIDED|95.0|-56.55|20.65|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||20.65|-56.55|0.3606
71038381|NCT01243151|141583769|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.33|STANDARD_ERROR_OF_MEAN|19.918||0.5364|TWO_SIDED|95.0|-51.55|26.89|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||26.89|-51.55|0.5364
71038382|NCT01243151|141583769|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.56|STANDARD_ERROR_OF_MEAN|20.069||0.5651|TWO_SIDED|95.0|-51.08|27.96|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||27.96|-51.08|0.5651
71098532|NCT03606213|141705476|OTHER|||||||0.56||||||P-value week 14 versus baseline (Cohort A, arm 1; placebo)|Wilcoxon (Mann-Whitney)|||||||0.56
71038383|NCT01243151|141583769|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.65|STANDARD_ERROR_OF_MEAN|20.332||0.4719|TWO_SIDED|95.0|-54.69|25.39|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||25.39|-54.69|0.4719
70988230|NCT00431847|141485056|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.108|STANDARD_ERROR_OF_MEAN|0.2308||0.64|TWO_SIDED|95.0|-0.5621|0.3461|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.|Estimated intercept group difference|A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.3461|-0.5621|0.640
70988231|NCT00431847|141485056|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3299|STANDARD_ERROR_OF_MEAN|0.3372||0.3286|TWO_SIDED|95.0|-0.3334|0.9932|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.9932|-0.3334|0.3286
71098533|NCT03074643|141705485|SUPERIORITY|||||||0.16|||||||ANCOVA|Adjusted for age, sex, race||||||0.16
71098534|NCT03074643|141705485|SUPERIORITY|||||||0.45|||||||ANCOVA|Adjusted for age, sex, race||||||0.45
71098535|NCT03074643|141705486|SUPERIORITY|||||||0.81|||||||ANCOVA|Adjusted for age, sex, race||||||0.81
71098536|NCT03074643|141705486|SUPERIORITY|||||||0.8|||||||ANCOVA|Adjusted for age, sex, race||||||0.80
71098537|NCT03074643|141705487|SUPERIORITY|||||||0.56|||||||ANCOVA|Adjusted for age, sex, race||||||0.56
71098538|NCT03074643|141705487|SUPERIORITY|||||||0.96|||||||ANCOVA|Adjusted for age, sex, race||||||0.96
71098539|NCT03074643|141705488|SUPERIORITY|||||||0.76|||||||ANCOVA|Adjusted for age, sex, race||||||0.76
71098540|NCT03074643|141705488|SUPERIORITY|||||||0.45|||||||ANCOVA|Adjusted for age, sex, race||||||0.45
71098541|NCT03074643|141705489|SUPERIORITY|||||||0.75|||||||ANCOVA|Adjusted for age, sex, race||||||0.75
71098542|NCT03074643|141705489|SUPERIORITY|||||||0.95|||||||ANCOVA|Adjusted for age, sex, race||||||0.95
71098543|NCT03074643|141705490|SUPERIORITY|||||||0.06|||||||ANCOVA|Adjusted for age, sex, race||||||0.06
70988232|NCT00431847|141485056|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8591|STANDARD_ERROR_OF_MEAN|0.4716||0.0694|TWO_SIDED|95.0|-0.06841|1.7866|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.7866|-0.06841|0.0694
70988233|NCT00431847|141485057|SUPERIORITY_OR_OTHER||Slope|-0.02332|STANDARD_ERROR_OF_MEAN|0.003777|<|0.0001|TWO_SIDED|95.0|-0.03076|-0.01589|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.01589|-0.03076|<0.0001
70988234|NCT00431847|141485057|SUPERIORITY_OR_OTHER||Chi-Squared|2.49||||0.4772|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.4772
70988235|NCT00431847|141485057|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07724|STANDARD_ERROR_OF_MEAN|0.1503||0.6077|TWO_SIDED|95.0|-0.2184|0.3729|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.3729|-0.2184|0.6077
70988236|NCT00431847|141485057|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2004|STANDARD_ERROR_OF_MEAN|0.2194||0.3616|TWO_SIDED|95.0|-0.2311|0.6319|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.6319|-0.2311|0.3616
70988237|NCT00431847|141485057|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3082|STANDARD_ERROR_OF_MEAN|0.3066||0.3155|TWO_SIDED|95.0|-0.2948|0.9112|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.9112|-0.2948|0.3155
70988238|NCT00431847|141485058|SUPERIORITY_OR_OTHER||Slope|-0.02746|STANDARD_ERROR_OF_MEAN|0.004202|<|0.0001|TWO_SIDED|95.0|-0.03573|-0.01919|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.01919|-0.03573|<0.0001
70988239|NCT00431847|141485058|SUPERIORITY_OR_OTHER||Chi-Squared|3.4||||0.3345|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.3345
71038384|NCT01243151|141583769|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.53|STANDARD_ERROR_OF_MEAN|19.601||0.3999|TWO_SIDED|95.0|-55.13|22.07|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||22.07|-55.13|0.3999
71038385|NCT03123874|141583802|OTHER|Linear mixed effects models testing the effect of pump set-up on the number of live aerobic bacterial counts. The fixed effect of interest will be pump set-up. Model will also be adjusted for infant feeding status (human milk only vs. human milk and complementary foods) and randomization schedule (which pump set-up went first).|Mean Difference (Final Values)|0.827||||0.9|TWO_SIDED|||||Results were considered statistically significant at p\<0.05. No adjustments were made to p-values.|Mixed Models Analysis||Ratio of mean bacterial taxa in milk collected with own / sterile pump set-ups.|||||0.9
70988240|NCT00431847|141485058|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0386|STANDARD_ERROR_OF_MEAN|0.1718||0.8223|TWO_SIDED|95.0|-0.2993|0.3765|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.3765|-0.2993|0.8223
70988241|NCT00431847|141485058|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2919|STANDARD_ERROR_OF_MEAN|0.2506||0.2448|TWO_SIDED|95.0|-0.2009|0.7848|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.7848|-0.2009|0.2448
70988242|NCT00431847|141485058|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4482|STANDARD_ERROR_OF_MEAN|0.3502||0.2014|TWO_SIDED|95.0|-0.2405|1.1369|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.1369|-0.2405|0.2014
71098544|NCT03074643|141705490|SUPERIORITY|||||||0.22|||||||ANCOVA|Adjusted for age, sex, race||||||0.22
71098545|NCT03074643|141705491|SUPERIORITY|||||||0.48|||||||ANCOVA|Adjusted for age, sex, race||||||0.48
70988243|NCT00431847|141485059|SUPERIORITY_OR_OTHER||Slope|-0.0403|STANDARD_ERROR_OF_MEAN|0.007196|<|0.0001|TWO_SIDED|95.0|-0.5446|-0.02613|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||-0.02613|-0.5446|<0.0001
70988244|NCT00431847|141485059|SUPERIORITY_OR_OTHER||Chi-Squared|3.19||||0.3631|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.3631
70988245|NCT00431847|141485059|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1004|STANDARD_ERROR_OF_MEAN|0.2746||0.7148|TWO_SIDED|95.0|-0.6404|0.4396|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.4396|-0.6404|0.7148
70988246|NCT00431847|141485059|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3568|STANDARD_ERROR_OF_MEAN|0.4009||0.3741|TWO_SIDED|95.0|-0.4318|1.1453|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.1453|-0.4318|0.3741
71038386|NCT03123874|141583803|OTHER|Linear mixed effects models testing the effect of pump set-up on the number of live aerobic bacterial counts. The fixed effect of interest will be pump set-up. Model will also be adjusted for infant feeding status (human milk only vs. human milk and complementary foods) and randomization schedule (which pump set-up went first).|Mean Difference (Final Values)|0.163||||0.3|TWO_SIDED|||||Results were considered statistically significant at p\<0.05. No adjustments were made to p-values.|Mixed Models Analysis||Ratio of mean Shannon Diversity Index in milk collected with own / sterile pump set-ups|||||0.3
71038387|NCT03123874|141583804|OTHER|Linear mixed effects models testing the effect of pump set-up on the number of live aerobic bacterial counts. The fixed effect of interest will be pump set-up. Model will also be adjusted for infant feeding status (human milk only vs. human milk and complementary foods) and randomization schedule (which pump set-up went first). Random effect was participant ID to account for multiple samples for each participant.|Mean Difference (Final Values)|4.95||||0.0003|TWO_SIDED|||||Results were considered statistically significant at p\<0.05. No adjustments were made to p-values.|Mixed Models Analysis||Ratio of mean bacterial counts in milk collected with own / sterile pump set-ups.|||||0.0003
71038388|NCT01630616|141583812|SUPERIORITY_OR_OTHER||Ratio (Adolescents/adults)|0.89|||||TWO_SIDED|90.0|0.62|1.26||||||||1.26|0.62|
71038389|NCT01630616|141583813|SUPERIORITY_OR_OTHER||Ratio (Adolescents/Adults)|0.87|||||TWO_SIDED|90.0|0.62|1.23||||||||1.23|0.62|
71038390|NCT01630616|141583814|SUPERIORITY_OR_OTHER||Ratio (Adolescents/Adults)|0.81|||||TWO_SIDED|90.0|0.57|1.16||||||||1.16|0.57|
71038391|NCT02218541|141583817|OTHER|||||||1||||||threshold for significance will be p-value \<0.05|Fisher Exact|||||||1.00
71038392|NCT02218541|141583818|OTHER|||||||0.039||||||This statistical analysis applies to Yes bleeding|Binomial|The statistical analysis was changed during the analysis phase but the protocol was not amended to reflect this change||||||0.039
70988247|NCT00431847|141485059|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2969|STANDARD_ERROR_OF_MEAN|0.5609||0.0213|TWO_SIDED|95.0|0.1938|2.4|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||2.4000|0.1938|0.0213
71038393|NCT02218541|141583819|EQUIVALENCE|No power calculation was done as this was a pilot study.||||||1||||||This statistical analysis applies to Yes Provisional Crown fit|Binomial|The statistical analysis was changed during the analysis phase but the protocol was not amended to reflect this change||||||1.0
71038394|NCT01993186|141583820|SUPERIORITY||Hodges-Lehmann estimate|13.45||||0.5812|TWO_SIDED|90.0|-38.63|80.95|||Wilcoxon rank-sum test|||Non-parametric post-hoc analysis: Hodges-Lehmann estimate of the location shift with 90% confidence interval (CI) and Wilcoxon Rank Sum test p-value, based on Wilcoxon rank-sum test||80.95|-38.63|0.5812
71038395|NCT01993186|141583823|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.8197|TWO_SIDED|90.0|-51.23|84.25|||Wilcoxon rank-sum test|||Non-parametric post-hoc analysis: Hodges-Lehmann estimate of the location shift with 90% CI and Wilcoxon Rank Sum test p-value, based on Wilcoxon rank-sum test||84.25|-51.23|0.8197
71038396|NCT01993186|141583824|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.7276|TWO_SIDED|90.0|0.0|37.5|||Wilcoxon rank-sum test|||Non-parametric post-hoc analysis: Hodges-Lehmann estimate of the location shift with 90% CI and Wilcoxon Rank Sum test p-value, based on Wilcoxon rank-sum test||37.5|0|0.7276
71038397|NCT01993186|141583828|SUPERIORITY||Least squares mean difference|-2.384|STANDARD_ERROR_OF_MEAN|68.1231||0.486|TWO_SIDED|90.0|-114.44|109.67||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||RTISRTSD||109.67|-114.44|0.486
71038398|NCT01993186|141583828|SUPERIORITY||Least squares mean difference|63.669|STANDARD_ERROR_OF_MEAN|53.0537||0.8849|TWO_SIDED|90.0|-23.6|150.94||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||RTIMDSRT||150.94|-23.6|0.8849
71038399|NCT01993186|141583828|SUPERIORITY||Least squares mean difference|-63.835|STANDARD_ERROR_OF_MEAN|60.6496||0.1463|TWO_SIDED|90.0|-163.59|35.93||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||RTIMDFRT||35.93|-163.59|0.1463
70988248|NCT00431847|141485060|SUPERIORITY_OR_OTHER||Slope|-0.02776|STANDARD_ERROR_OF_MEAN|0.004706|<|0.0001|TWO_SIDED|95.0|-0.03702|-0.0185|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.01850|-0.03702|<0.0001
70988249|NCT00431847|141485060|SUPERIORITY_OR_OTHER||Chi-Squared|3.88||||0.2752|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.2752
70988250|NCT00431847|141485060|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3079|STANDARD_ERROR_OF_MEAN|0.1918||0.1094|TWO_SIDED|95.0|-0.6851|0.06941|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.06941|-0.6851|0.1094
70988251|NCT00431847|141485060|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0428|STANDARD_ERROR_OF_MEAN|0.28||0.8786|TWO_SIDED|95.0|-0.5079|0.5935|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.5935|-0.5079|0.8786
70988252|NCT00431847|141485060|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6759|STANDARD_ERROR_OF_MEAN|0.391||0.0847|TWO_SIDED|95.0|-0.09297|1.4448|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.4448|-0.09297|0.0847
70988253|NCT00431847|141485061|SUPERIORITY_OR_OTHER||Slope|-0.03645|STANDARD_ERROR_OF_MEAN|0.005913|<|0.0001|TWO_SIDED|95.0|-0.04808|-0.02481|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.02481|-0.04808|<0.0001
70988254|NCT00431847|141485061|SUPERIORITY_OR_OTHER||Chi-Squared|3.16||||0.3677|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.3677
70988255|NCT00431847|141485061|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05816|STANDARD_ERROR_OF_MEAN|0.221||0.7926|TWO_SIDED|95.0|-0.4929|0.3766|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.3766|-0.4929|0.7926
70988256|NCT00431847|141485061|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1708|STANDARD_ERROR_OF_MEAN|0.3212||0.5953|TWO_SIDED|95.0|-0.461|0.8026|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.8026|-0.4610|0.5953
70988257|NCT00431847|141485061|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6873|STANDARD_ERROR_OF_MEAN|0.4482||0.1261|TWO_SIDED|95.0|-0.1943|1.5689|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.5689|-0.1943|0.1261
70988258|NCT00431847|141485062|SUPERIORITY_OR_OTHER||Slope|-0.4831|STANDARD_ERROR_OF_MEAN|0.1243||0.0002|TWO_SIDED|95.0|-0.7286|-0.2377|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.2377|-0.7286|0.0002
70988259|NCT00431847|141485062|SUPERIORITY_OR_OTHER||Chi-Squared|3.2||||0.3617|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.3617
71038400|NCT01993186|141583829|SUPERIORITY||Least squares mean difference|17.768|STANDARD_ERROR_OF_MEAN|11.5659||0.9378|TWO_SIDED|90.0|-1.26|36.79||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||PALTEA||36.79|-1.26|0.9378
71098546|NCT03074643|141705491|SUPERIORITY|||||||0.22|||||||ANCOVA|Adjusted for age, sex, race||||||0.22
70988260|NCT00431847|141485062|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.1574|STANDARD_ERROR_OF_MEAN|2.7573||0.2532|TWO_SIDED|95.0|-2.2715|8.5863|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||8.5863|-2.2715|0.2532
70988261|NCT00431847|141485062|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2227|STANDARD_ERROR_OF_MEAN|3.9633||0.758|TWO_SIDED|95.0|-6.5833|9.0286|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||9.0286|-6.5833|0.7580
70988262|NCT00431847|141485062|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.1649|STANDARD_ERROR_OF_MEAN|5.3759||0.1837|TWO_SIDED|95.0|-17.7484|3.4187|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||3.4187|-17.7484|0.1837
70988263|NCT00431847|141485063|SUPERIORITY_OR_OTHER||Slope|0.4741|STANDARD_ERROR_OF_MEAN|0.03909|<|0.0001|TWO_SIDED|95.0|0.3971|0.5511|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||0.5511|0.3971|<0.0001
70988264|NCT00431847|141485063|SUPERIORITY_OR_OTHER||Chi-Squared|1.83||||0.6075|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.6075
70988265|NCT00431847|141485063|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9534|STANDARD_ERROR_OF_MEAN|1.2763||0.4558|TWO_SIDED|95.0|-3.4675|1.5607|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.5607|-3.4675|0.4558
70988266|NCT00431847|141485063|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3505|STANDARD_ERROR_OF_MEAN|1.977||0.0914|TWO_SIDED|95.0|-7.2442|0.5432|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.5432|-7.2442|0.0914
70988267|NCT00431847|141485063|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.37|STANDARD_ERROR_OF_MEAN|3.0921||0.007|TWO_SIDED|95.0|-14.4589|-2.281|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||-2.2810|-14.4589|0.007
70988268|NCT00431847|141485064|SUPERIORITY_OR_OTHER||Slope|-0.2169|STANDARD_ERROR_OF_MEAN|0.04148|<|0.0001|TWO_SIDED|95.0|-0.2987|-0.1352|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.1352|-0.2987|<0.0001
70988269|NCT00431847|141485064|SUPERIORITY_OR_OTHER||Chi-Squared|6.37||||0.095|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.0950
70988270|NCT00431847|141485064|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7246|STANDARD_ERROR_OF_MEAN|1.3351||0.5878|TWO_SIDED|95.0|-1.9056|3.3547|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||3.3547|-1.9056|0.5878
71038401|NCT01993186|141583829|SUPERIORITY||Least squares mean difference|-0.531|STANDARD_ERROR_OF_MEAN|2.1853||0.5959|TWO_SIDED|90.0|-4.13|3.06||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||PALFTMS||3.06|-4.13|0.5959
70988271|NCT00431847|141485064|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2466|STANDARD_ERROR_OF_MEAN|2.0697||0.9053|TWO_SIDED|95.0|-4.3231|3.8299|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||3.8299|-4.3231|0.9053
70988272|NCT00431847|141485064|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3457|STANDARD_ERROR_OF_MEAN|3.2285||0.4682|TWO_SIDED|95.0|-8.7034|4.012|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||4.0120|-8.7034|0.4682
70988273|NCT00431847|141485065|SUPERIORITY_OR_OTHER||Slope|0.04639|STANDARD_ERROR_OF_MEAN|0.03562||0.1938|TWO_SIDED|95.0|-0.02369|0.1165|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||0.1165|-0.02369|0.1938
70988274|NCT00431847|141485065|SUPERIORITY_OR_OTHER||Chi-Squared|2.43||||0.4884|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.4884
70988275|NCT00431847|141485065|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6174|STANDARD_ERROR_OF_MEAN|1.3991||0.6593|TWO_SIDED|95.0|-2.1348|3.3696|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||3.3696|-2.1348|0.6593
70988276|NCT00431847|141485065|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.4575|STANDARD_ERROR_OF_MEAN|2.0263||0.0889|TWO_SIDED|95.0|-0.528|7.4431|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||7.4431|-0.5280|0.0889
70988277|NCT00431847|141485065|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4499|STANDARD_ERROR_OF_MEAN|2.8061||0.8727|TWO_SIDED|95.0|-5.9692|5.0694|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||5.0694|-5.9692|0.8727
70988278|NCT00431847|141485066|SUPERIORITY_OR_OTHER||Slope|-0.523|STANDARD_ERROR_OF_MEAN|0.08855|<|0.0001|TWO_SIDED|95.0|-0.6973|-0.3486|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.3486|-0.6973|<.0001
70988279|NCT00431847|141485066|SUPERIORITY_OR_OTHER||Chi-Squared|4.89||||0.18|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.1800
70988280|NCT00431847|141485066|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.302|STANDARD_ERROR_OF_MEAN|2.8198||0.4151|TWO_SIDED|95.0|-3.253|7.857|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||7.8570|-3.2530|0.4151
70988281|NCT00431847|141485066|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.3376|STANDARD_ERROR_OF_MEAN|4.314||0.3157|TWO_SIDED|95.0|-4.1592|12.8344|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||12.8344|-4.1592|0.3157
70988282|NCT00431847|141485066|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.825|STANDARD_ERROR_OF_MEAN|6.9715||0.0911|TWO_SIDED|95.0|-1.904|25.5541|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||25.5541|-1.9040|0.0911
71038402|NCT01993186|141583830|SUPERIORITY||Least squares mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.4988||0.4522|TWO_SIDED|90.0|-0.76|0.88||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||SSPSLF||0.88|-0.76|0.4522
70988283|NCT00431847|141485067|SUPERIORITY_OR_OTHER||Slope|-0.2888|STANDARD_ERROR_OF_MEAN|0.09078||0.0016|TWO_SIDED|95.0|-0.4675|-0.11|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.1100|-0.4675|0.0016
70988284|NCT00431847|141485067|SUPERIORITY_OR_OTHER||Chi-Squared|6.33||||0.0966|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.0966
70988285|NCT00431847|141485067|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9879|STANDARD_ERROR_OF_MEAN|2.4264||0.2195|TWO_SIDED|95.0|-1.7938|7.7697|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||7.7697|-1.7938|0.2195
70988286|NCT00431847|141485067|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4636|STANDARD_ERROR_OF_MEAN|3.7381||0.5105|TWO_SIDED|95.0|-9.8289|4.9018|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||4.9018|-9.8289|0.5105
70988287|NCT00431847|141485067|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.3871|STANDARD_ERROR_OF_MEAN|6.1087||0.0903|TWO_SIDED|95.0|-22.4174|1.6433|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.6433|-22.4174|0.0903
70988288|NCT00431847|141485068|SUPERIORITY_OR_OTHER||Slope|-0.04113|STANDARD_ERROR_OF_MEAN|-0.04113||0.6602|TWO_SIDED|95.0|-0.2252|0.1429|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||0.1429|-0.2252|0.6602
70988289|NCT00431847|141485068|SUPERIORITY_OR_OTHER||Chi-Squared|1.53||||0.6764|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.6764
71098547|NCT01655069|141705524|OTHER||Adjusted change from baseline|-0.95|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-1.19|-0.71|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.71|-1.19|
71098548|NCT01655069|141705524|OTHER||Adjusted change from baseline|-1.11|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-1.34|-0.88|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.88|-1.34|
71038403|NCT01993186|141583831|SUPERIORITY||LS Mean Difference|-1.237|STANDARD_ERROR_OF_MEAN|2.381||0.3017|TWO_SIDED|90.0|-5.15|2.68||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||SWMBE48||2.68|-5.15|0.3017
70988290|NCT00431847|141485068|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.4902|STANDARD_ERROR_OF_MEAN|2.6357||0.3458|TWO_SIDED|95.0|-2.7036|7.684|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||7.6840|-2.7036|0.3458
70988291|NCT00431847|141485068|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.2518|STANDARD_ERROR_OF_MEAN|4.0583||0.1969|TWO_SIDED|95.0|-13.2466|2.743|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||2.7430|-13.2466|0.1969
71038404|NCT01993186|141583831|SUPERIORITY||Least squares mean difference|0.038|STANDARD_ERROR_OF_MEAN|0.6495||0.5235|TWO_SIDED|90.0|-1.03|1.11||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||SWMS68||1.11|-1.03|0.5235
71098549|NCT01655069|141705524|OTHER||Adjusted change from baseline|-1.26|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-1.53|-1.0|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.00|-1.53|
71098550|NCT01655069|141705524|OTHER||Adjusted change from baseline|-1.39|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-1.63|-1.16|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.16|-1.63|
70988292|NCT00431847|141485068|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.9796|STANDARD_ERROR_OF_MEAN|6.5287||0.048|TWO_SIDED|95.0|-25.8429|-0.1162|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||-0.1162|-25.8429|0.0480
70988293|NCT00431847|141485069|SUPERIORITY_OR_OTHER||Slope|-0.2349|STANDARD_ERROR_OF_MEAN|0.1003||0.0199|TWO_SIDED|95.0|-0.4323|-0.03745|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.03745|-0.4323|0.0199
70988294|NCT00431847|141485069|SUPERIORITY_OR_OTHER||Chi-Squared|2.6||||0.4577|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.4577
70988295|NCT00431847|141485069|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9502|STANDARD_ERROR_OF_MEAN|2.8797||0.7417|TWO_SIDED|95.0|-6.624|4.7236|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||4.7236|-6.6240|0.7417
71098551|NCT01655069|141705524|OTHER||Adjusted change from baseline|-1.54|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-1.76|-1.32|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.32|-1.76|
71098552|NCT01655069|141705524|OTHER||Adjusted change from baseline|-1.56|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-1.81|-1.31|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"||-1.31|-1.81|
70988296|NCT00431847|141485069|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.258|STANDARD_ERROR_OF_MEAN|4.4523||0.7778|TWO_SIDED|95.0|-7.5129|10.0289|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||10.0289|-7.5129|0.7778
70988297|NCT00431847|141485069|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.5232|STANDARD_ERROR_OF_MEAN|7.2532||0.2411|TWO_SIDED|95.0|-5.7608|22.8073|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||22.8073|-5.7608|0.2411
70988298|NCT00431847|141485070|SUPERIORITY_OR_OTHER||Slope|0.1629|STANDARD_ERROR_OF_MEAN|0.08284||0.0504|TWO_SIDED|95.0|-0.00029|0.3261|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||0.3261|-0.00029|0.0504
70988299|NCT00431847|141485070|SUPERIORITY_OR_OTHER||Chi-Squared|1.45||||0.6942|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.6942
70988300|NCT00431847|141485070|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5241|STANDARD_ERROR_OF_MEAN|2.4216||0.5297|TWO_SIDED|95.0|-3.2469|6.2951|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||6.2951|-3.2469|0.5297
70988301|NCT00431847|141485070|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.7679|STANDARD_ERROR_OF_MEAN|3.7464||0.3155|TWO_SIDED|95.0|-11.1478|3.612|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||3.6120|-11.1478|0.3155
70988302|NCT00431847|141485070|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.7558|STANDARD_ERROR_OF_MEAN|6.092||0.1105|TWO_SIDED|95.0|-21.7515|2.2399|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||2.2399|-21.7515|0.1105
70988303|NCT00431847|141485071|SUPERIORITY_OR_OTHER||Slope|-0.2979|STANDARD_ERROR_OF_MEAN|0.07538||0.001|TWO_SIDED|95.0|-0.4465|-0.1493|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.1493|-0.4465|0.001
70988304|NCT00431847|141485071|SUPERIORITY_OR_OTHER||Chi-Squared|2.72||||0.4361|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.4361
70988305|NCT00431847|141485071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9001|STANDARD_ERROR_OF_MEAN|2.6015||0.7297|TWO_SIDED|95.0|-6.0247|4.2246|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||4.2246|-6.0247|0.7297
70988306|NCT00431847|141485071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.2896|STANDARD_ERROR_OF_MEAN|4.0186||0.2868|TWO_SIDED|95.0|-3.625|12.2043|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||12.2043|-3.6250|0.2868
70988307|NCT00431847|141485071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.0118|STANDARD_ERROR_OF_MEAN|6.2663||0.1516|TWO_SIDED|95.0|-3.327|21.3505|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||21.3505|-3.3270|0.1516
71098553|NCT01655069|141705524|OTHER||Adjusted change from baseline|-1.93|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-2.19|-1.67|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.67|-2.19|
70988308|NCT00431847|141485072|SUPERIORITY_OR_OTHER||Slope|-0.9776|STANDARD_ERROR_OF_MEAN|0.1426|<|0.0001|TWO_SIDED|95.0|-1.2584|-0.6967|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury. T||-0.6967|-1.2584|<0.0001
70988309|NCT00431847|141485072|SUPERIORITY_OR_OTHER||Chi-Squared|0.78||||0.8548|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.8548
70988310|NCT00431847|141485072|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.3635|STANDARD_ERROR_OF_MEAN|3.8899||0.3882|TWO_SIDED|95.0|-4.3026|11.0296|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||11.0296|-4.3026|0.3882
70988311|NCT00431847|141485072|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5029|STANDARD_ERROR_OF_MEAN|5.9044||0.9322|TWO_SIDED|95.0|-12.1376|11.1317|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||11.1317|-12.1376|0.9322
70988312|NCT00431847|141485072|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.1166|STANDARD_ERROR_OF_MEAN|9.2462||0.0233|TWO_SIDED|95.0|2.8992|39.3341|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||39.3341|2.8992|0.0233
70988313|NCT01469013|141485073|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
70988314|NCT01469013|141485075|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED||||||Cochran-Armitage trend test|||||||0.009
70988315|NCT03161678|141485111|OTHER|The effect of CES1 genotype on agonist-stimulated change in platelet aggregation was calculated using variance component method that simultaneously adjusted for age, sex, body mass index (BMI), and relatedness among study participants. Relatedness among participants were accounted for by including a polygenic component as a random effect. Please see the Study Protocol and Statistical Analysis Plan document for additional information.|||||<|0.001|||||||Regression, Linear|All analyses were adjusted for age, sex, body mass index (BMI), and relatedness among study participants.||Change in platelet aggregation was assessed between the wild-type group and the carriers of the CES1 G143E mutation. The null hypothesis is that, following drug intervention, there is no difference in the change in platelet aggregation between genotype groups.||||<0.001
70988316|NCT03161678|141485111|OTHER|The effect of CES1 genotype on agonist-stimulated change in platelet aggregation was calculated using variance component method that simultaneously adjusted for age, sex, body mass index (BMI), and relatedness among study participants. Relatedness among participants were accounted for by including a polygenic component as a random effect. Please see the Study Protocol and Statistical Analysis Plan document for additional information.||||||0.24|||||||Regression, Linear|All analyses were adjusted for age, sex, body mass index (BMI), and relatedness among study participants.||Change in platelet aggregation was assessed between the wild-type group and the carriers of the CES1 functional mutation (rs7498748). The null hypothesis is that, following drug intervention, there is no difference in the change in platelet aggregation between genotype groups.||||0.24
70988317|NCT03161678|141485112|OTHER|The effect of CES1 genotype on agonist-stimulated change in platelet aggregation was calculated using variance component method that simultaneously adjusted for age, sex, body mass index (BMI), and relatedness among study participants. Relatedness among participants were accounted for by including a polygenic component as a random effect. Please see the Study Protocol and Statistical Analysis Plan document for additional information.||||||0.75|||||||Regression, Linear|All analyses were adjusted for age, sex, body mass index (BMI), and relatedness among study participants.||Change in platelet aggregation was assessed between the wild-type group and the carriers of the CES1 G143E mutation. The null hypothesis is that, following drug intervention, there is no difference in the change in platelet aggregation between genotype groups.||||0.75
70988318|NCT03161678|141485112|OTHER|The effect of CES1 genotype on agonist-stimulated change in platelet aggregation was calculated using variance component method that simultaneously adjusted for age, sex, body mass index (BMI), and relatedness among study participants. Relatedness among participants were accounted for by including a polygenic component as a random effect. Please see the Study Protocol and Statistical Analysis Plan document for additional information.||||||0.011|||||||Regression, Linear|All analyses were adjusted for age, sex, body mass index (BMI), and relatedness among study participants.||Change in platelet aggregation was assessed between the wild-type group and the carriers of the CES1 functional mutation (rs7498748). The null hypothesis is that, following drug intervention, there is no difference in the change in platelet aggregation between genotype groups.||||0.011
70988319|NCT00739297|141485113|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.04||||||95.0|-0.01|0.08|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.08|-0.01|
71098554|NCT01655069|141705524|OTHER||Adjusted change from baseline|-0.93|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-1.62|-0.23|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.23|-1.62|
70988320|NCT00739297|141485113|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.1||||||95.0|0.04|0.15|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.15|0.04|
70988321|NCT00739297|141485113|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.06||||||95.0|0.02|0.11|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.11|0.02|
70988322|NCT00739297|141485113|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.05||||||95.0|-0.01|0.11|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.11|-0.01|
70988323|NCT00739297|141485113|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.08||||||95.0|0.04|0.13|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.13|0.04|
70988324|NCT00739297|141485114|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.19||||||95.0|0.04|0.34|||||Repeated measures model with terms for treatment (Albuterol/Placebo), dose, treatment-by-dose interaction and baseline FEV1|||0.34|0.04|
70988325|NCT00739297|141485115|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.06||||||95.0|-0.01|0.12|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.12|-0.01|
71098555|NCT01655069|141705524|OTHER||Adjusted change from baseline|-1.38|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-2.09|-0.68|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"||-0.68|-2.09|
71098556|NCT01655069|141705524|OTHER||Adjusted change from baseline|-1.4|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-2.09|-0.7|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.70|-2.09|
71098557|NCT01655069|141705524|OTHER||Adjusted change from baseline|-1.58|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-2.27|-0.88|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.88|-2.27|
71098558|NCT01655069|141705524|OTHER||Adjusted change from baseline|-1.8|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-2.5|-1.1|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.10|-2.50|
71098559|NCT01655069|141705524|OTHER||Adjusted change from baseline|-1.57|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-2.29|-0.85|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.85|-2.29|
71098560|NCT01655069|141705524|OTHER||Adjusted change from baseline|-2.0|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-2.83|-1.17|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.17|-2.83|
71098561|NCT01655069|141705525|OTHER||Adjusted change from baseline|1.35|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|0.97|1.73|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||1.73|0.97|
71098562|NCT01655069|141705525|OTHER||Adjusted change from baseline|1.43|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|1.02|1.83|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||1.83|1.02|
70988326|NCT00739297|141485115|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.07||||||95.0|0.0|0.15|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.15|-0.00|
70988327|NCT00739297|141485115|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.05||||||95.0|-0.01|0.11|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.11|-0.01|
70988328|NCT00739297|141485115|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.06||||||95.0|-0.03|0.14|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.14|-0.03|
70988329|NCT00739297|141485115|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.08||||||95.0|0.01|0.15|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.15|0.01|
70988330|NCT00739297|141485116|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.04||||||95.0|-0.03|0.1|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.10|-0.03|
70988331|NCT00739297|141485116|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.09||||||95.0|0.01|0.17|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.17|0.01|
70988332|NCT00739297|141485116|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.05||||||95.0|-0.01|0.1|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.10|-0.01|
70988333|NCT00739297|141485116|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.07||||||95.0|-0.02|0.15|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.15|-0.02|
70988334|NCT00739297|141485116|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.08||||||95.0|0.01|0.15|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.15|0.01|
70988335|NCT02749721|141485121|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
70988336|NCT02749721|141485122|OTHER|||||||0.012|||||||Paired t-test|||||||0.012
70988337|NCT02749721|141485123|OTHER||Pearson's R|0.125||||0.61|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P200 (amplitude) baseline scores||||0.610
70988338|NCT02749721|141485123|OTHER||Pearson's R|-0.294||||0.288|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P3a (amplitude) baseline scores||||0.288
70988339|NCT02749721|141485123|OTHER||Pearson's R|-0.405||||0.134|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P3b (amplitude) baseline scores||||0.134
70988340|NCT02749721|141485123|OTHER||Pearson's R|-0.397||||0.083|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and VGNG P200 (amplitude) baseline scores||||0.083
70988341|NCT02749721|141485123|OTHER||Pearson's R|-0.476||||0.034|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and VGNG P3a (amplitude) baseline scores||||0.034
70988342|NCT02749721|141485123|OTHER||Pearson's R|-0.509||||0.031|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P200 baseline scores||||0.031
70988343|NCT02749721|141485123|OTHER||Pearson's R|-0.197||||0.5|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P3a (amplitude) baseline scores||||0.500
70988344|NCT02749721|141485123|OTHER||Pearson's R|0.376||||0.185|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P3b baseline scores||||0.185
70988345|NCT02749721|141485123|OTHER||Pearson's R|-0.108||||0.659|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and VGNG P200 baseline scores||||0.659
70988346|NCT02749721|141485123|OTHER||Pearson's R|0.125||||0.611|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and VGNG P3a baseline scores||||0.611
70988347|NCT02749721|141485123|OTHER||Pearson's R|-0.111||||0.671|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and MADRS (baseline to endpoint percent change)||||0.671
70988348|NCT02749721|141485123|OTHER||Pearson's R|-0.026||||0.931|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and MADRS (baseline to endpoint percent change)||||0.931
70988349|NCT02749721|141485123|OTHER||Pearson's R|0.516||||0.155|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and MADRS (baseline to endpoint percent change)||||0.155
70988350|NCT02749721|141485123|OTHER||Pearson's R|0.268||||0.297|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and MADRS (baseline to endpoint percent change)||||0.297
70988351|NCT02749721|141485123|OTHER||Pearson's R|0.184||||0.494|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and MADRS (baseline to endpoint percent change)||||0.494
70988352|NCT02749721|141485123|OTHER||Pearson's R|-0.065||||0.811|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and DSST (baseline to endpoint percent change)||||0.811
70988353|NCT02749721|141485123|OTHER||Pearson's R|-0.048||||0.877|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and DSST (baseline to endpoint percent change)||||0.877
70988354|NCT02749721|141485123|OTHER||Pearson's R|-0.246||||0.557|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and DSST (baseline to endpoint percent change)||||0.557
70988355|NCT02749721|141485123|OTHER||Pearson's R|0.182||||0.5|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and DSST (baseline to endpoint percent change)||||0.500
70988356|NCT02749721|141485123|OTHER||Pearson's R|0.288||||0.297|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and DSST (baseline to endpoint percent change)||||0.297
70988357|NCT02749721|141485123|OTHER|Differences in BNA scores between MDD and healthy subjects were analyzed for baseline visits using an ANCOVA model with group as a factor, and age as a covariate.|F statistic|0.318||||0.575|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P200 amplitudes at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.575
70988358|NCT02749721|141485123|OTHER||F statistic|0.378||||0.541|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P200 amplitudes at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.541
70988359|NCT02749721|141485123|OTHER||F|0.012||||0.912|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3a amplitudes at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.912
70988360|NCT02749721|141485123|OTHER||F statistic|1.586||||0.214|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3a amplitudes at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.214
70988361|NCT02749721|141485123|OTHER||F statistic|0.453||||0.504|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3b amplitudes at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.504
71038405|NCT01993186|141583832|SUPERIORITY||Least squares mean difference|-6.897|STANDARD_ERROR_OF_MEAN|22.4806||0.6205|TWO_SIDED|90.0|-43.874|30.08||One-sided p-value. Additional model covariates include the corresponding baseline value, visit and the interaction between visit and treatment.|GEE model|||6MWT distance traveled||30.08|-43.874|0.6205
70988362|NCT02749721|141485123|OTHER||F statistic|0.37||||0.546|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3b amplitudes at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.546
70988363|NCT02749721|141485123|OTHER||F statistic|0.017||||0.895|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P200 amplitudes at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.895
70988364|NCT02749721|141485123|OTHER||F statistic|0.179||||0.673|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P200 amplitudes at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.673
70988365|NCT02749721|141485123|OTHER||F statistic|1.241||||0.27|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P3a amplitudes at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.27
70988366|NCT02749721|141485123|OTHER||F statistic|0.042||||0.837|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P3a amplitudes at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.837
70988367|NCT02749721|141485124|OTHER||Pearson's R|0.359||||0.143|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P200 (Latency) baseline scores||||0.143
71038406|NCT01993186|141583833|SUPERIORITY||Least squares mean difference|-1.354|STANDARD_ERROR_OF_MEAN|3.5759||0.6476|TWO_SIDED|90.0|-7.236|4.527||One-sided p-value. Additional model covariates include the corresponding baseline value, visit and the interaction between visit and treatment.|GEE model|||6MWT distance traveled (percent predicted)||4.527|-7.236|0.6476
71038407|NCT01993186|141583835|SUPERIORITY||Least squares mean difference|1.568|STANDARD_ERROR_OF_MEAN|3.8899||0.3435|TWO_SIDED|90.0|-4.83|7.97||One-sided p-value. Additional model covariates include baseline GMFM-88 total score, visit and the interaction between visit and treatment.|GEE model|||GMFM-88 UX007-Placebo||7.97|-4.83|0.3435
71038408|NCT01634139|141583921|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001|TWO_SIDED|95.0|0.108|0.231|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis was performed in a stepwise manner, firstly for this endpoint, then Trough FEV1. Each step was only considered confirmatory if all previous steps were successful.||0.231|0.108|<0.0001
71038409|NCT01634139|141583921|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.164|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001|TWO_SIDED|95.0|0.103|0.255|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis was performed in a stepwise manner, firstly for this endpoint, then Trough FEV1. Each step was only considered confirmatory if all previous steps were successful.||0.255|0.103|<0.0001
71038410|NCT01634139|141583922|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.116|STANDARD_ERROR_OF_MEAN|0.036||0.0012|TWO_SIDED|95.0|0.046|0.186|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.186|0.046|0.0012
71038411|NCT01634139|141583922|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.118|STANDARD_ERROR_OF_MEAN|0.036||0.001|TWO_SIDED|95.0|0.048|0.188|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.188|0.048|0.0010
71038412|NCT01634139|141583922|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.071|STANDARD_ERROR_OF_MEAN|0.036||0.0477|TWO_SIDED|95.0|0.001|0.142|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.142|0.001|0.0477
71038413|NCT01634139|141583922|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.099|STANDARD_ERROR_OF_MEAN|0.036||0.0059|TWO_SIDED|95.0|0.029|0.17|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.170|0.029|0.0059
71038414|NCT01634139|141583923|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.124|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001|TWO_SIDED|95.0|0.062|0.185|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.185|0.062|<0.0001
70988368|NCT02749721|141485124|OTHER||Pearson's R|-0.197||||0.5|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P3b (latency) baseline scores||||0.500
70988369|NCT02749721|141485124|OTHER||Pearson's R|0.277||||0.337|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P3b (latency) baseline scores||||0.337
70988370|NCT02749721|141485124|OTHER||Pearson's R|0.052||||0.832|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and VGNG P200 (latency) baseline scores||||0.832
70988371|NCT02749721|141485124|OTHER||Pearson's R|0.103||||0.68|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and VGNG P3a (latency) baseline scores||||0.68
71038415|NCT01634139|141583923|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.127|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001|TWO_SIDED|95.0|0.065|0.188|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.188|0.065|<0.0001
71038416|NCT01634139|141583924|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.154|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.095|0.212|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.212|0.095|<0.0001
71038417|NCT01634139|141583924|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.157|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.098|0.215|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.215|0.098|<0.0001
70988372|NCT02749721|141485124|OTHER||Pearson's R|-0.074||||0.777|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P200 (Latency) baseline to endpoint percentage change||||0.777
70988373|NCT02749721|141485124|OTHER||Pearson's R|0.061||||0.834|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P3a (Latency) baseline to endpoint percentage change||||0.834
70988374|NCT02749721|141485124|OTHER||Pearson's R|-0.006||||0.988|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P3b (Latency) baseline to endpoint percentage change||||0.988
70988375|NCT02749721|141485124|OTHER||Pearson's R|0.073||||0.788|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and VGNG P200 (Latency) baseline to endpoint percentage change||||0.788
70988376|NCT02749721|141485124|OTHER||Pearson's R|0.375||||0.168|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and VGNG P3a (Latency) baseline to endpoint percentage change||||0.168
70988377|NCT02749721|141485124|OTHER||Pearson's R|-0.392||||0.108|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P200 (Latency) baseline scores||||0.108
70988378|NCT02749721|141485124|OTHER||Pearson's R|0.415||||0.124|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P3a (Latency) baseline scores||||0.124
70988379|NCT02749721|141485124|OTHER||Pearson's R|0.362||||0.185|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P3b (Latency) baseline scores||||0.185
70988380|NCT02749721|141485124|OTHER||Pearson's R|-0.023||||0.923|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and VGNG P200 (Latency) baseline scores||||0.923
71038418|NCT01634139|141583925|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.116|STANDARD_ERROR_OF_MEAN|0.036||0.0012|TWO_SIDED|95.0|0.046|0.186|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|10 minutes pre-dose (Week 24)||0.186|0.046|0.0012
71038419|NCT01634139|141583925|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.118|STANDARD_ERROR_OF_MEAN|0.036||0.001|TWO_SIDED|95.0|0.048|0.188|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|10 minutes pre-dose (Week 24)||0.188|0.048|0.0010
70988381|NCT02749721|141485124|OTHER||Pearson's R|0.071||||0.77|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and VGNG P3a (Latency) baseline scores||||0.77
70988382|NCT02749721|141485124|OTHER||Pearson's R|0.097||||0.712|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P200 (Latency) baseline to endpoint percent change||||0.712
70988383|NCT02749721|141485124|OTHER||Pearson's R|-0.058||||0.845|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P3a (Latency) baseline to endpoint percent change||||0.845
70988384|NCT02749721|141485124|OTHER||Pearson's R|0.194||||0.616|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P3b (Latency) baseline to endpoint percent change||||0.616
70988385|NCT02749721|141485124|OTHER||Pearson's R|0.255||||0.323|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and VGNG P200 (Latency) baseline to endpoint percent change||||0.323
70988386|NCT02749721|141485124|OTHER||Pearson's R|-0.193||||0.473|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and VGNG P3a (Latency) baseline to endpoint percent change||||0.473
71038420|NCT01634139|141583925|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.139|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.076|0.201|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|30 minutes post-dose (Week 24)||0.201|0.076|<0.0001
71038421|NCT01634139|141583925|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.151|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.088|0.213|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|30 minutes post-dose (Week 24)||0.213|0.088|<0.0001
70988387|NCT02749721|141485124|OTHER||F statistic|4.909||||0.031|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P200 latencies at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.031
70988388|NCT02749721|141485124|OTHER||F statistic|1.189||||0.281|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P200 latencies at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.281
70988389|NCT02749721|141485124|OTHER||F statistic|0.001||||0.966|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3a latencies at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.966
70988390|NCT02749721|141485124|OTHER||F statistic|4.121||||0.048|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3a latencies at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.048
70988391|NCT02749721|141485124|OTHER||F statistic|8.573||||0.005|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3b latencies at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.005
71038422|NCT01634139|141583925|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.148|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.084|0.211|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|1 hour post-dose (Week 24)||0.211|0.084|<0.0001
71038423|NCT01634139|141583925|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.147|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.084|0.21|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|1 hour post-dose (Week 24)||0.210|0.084|<0.0001
71038424|NCT01634139|141583925|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.163|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.101|0.226|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|2 hours post-dose (Week 24)||0.226|0.101|<0.0001
71038425|NCT01634139|141583925|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.168|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.106|0.231|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|2 hours post-dose (Week 24)||0.231|0.106|<0.0001
71038426|NCT01634139|141583925|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.178|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.116|0.24|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|3 hours post-dose (Week 24)||0.240|0.116|<0.0001
71038427|NCT01634139|141583925|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.176|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.114|0.238|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|3 hours post-dose (Week 24)||0.238|0.114|<0.0001
71038428|NCT01634139|141583926|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.038||0.0036|TWO_SIDED|95.0|0.036|0.184|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.184|0.036|0.0036
71038429|NCT01634139|141583926|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.091|STANDARD_ERROR_OF_MEAN|0.037||0.0152|TWO_SIDED|95.0|0.018|0.165|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.165|0.018|0.0152
71038430|NCT01634139|141583926|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.069|STANDARD_ERROR_OF_MEAN|0.038||0.0687|TWO_SIDED|95.0|-0.005|0.143|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.143|-0.005|0.0687
71038431|NCT01634139|141583926|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.052|STANDARD_ERROR_OF_MEAN|0.038||0.1666|TWO_SIDED|95.0|-0.022|0.126|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.126|-0.022|0.1666
71038432|NCT01634139|141583927|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.092|STANDARD_ERROR_OF_MEAN|0.04||0.0228|TWO_SIDED|95.0|0.013|0.171|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.171|0.013|0.0228
71038433|NCT01634139|141583927|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.052|STANDARD_ERROR_OF_MEAN|0.04||0.198|TWO_SIDED|95.0|-0.027|0.131|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.131|-0.027|0.1980
71038434|NCT01634139|141583927|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.062|STANDARD_ERROR_OF_MEAN|0.04||0.1256|TWO_SIDED|95.0|-0.017|0.141|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.141|-0.017|0.1256
71038435|NCT01634139|141583927|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.053|STANDARD_ERROR_OF_MEAN|0.04||0.188|TWO_SIDED|95.0|-0.026|0.133|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.133|-0.026|0.1880
71038436|NCT01634139|141583928|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.105|STANDARD_ERROR_OF_MEAN|0.034||0.0023|TWO_SIDED|95.0|0.037|0.172|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.172|0.037|0.0023
71038437|NCT01634139|141583928|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.076|STANDARD_ERROR_OF_MEAN|0.034||0.0255|TWO_SIDED|95.0|0.009|0.143|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.143|0.009|0.0255
71038438|NCT01634139|141583929|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.092|STANDARD_ERROR_OF_MEAN|0.04||0.0228|TWO_SIDED|95.0|0.013|0.171|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|10 minutes pre-dose (Week 24)||0.171|0.013|0.0228
71038439|NCT01634139|141583929|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.052|STANDARD_ERROR_OF_MEAN|0.04||0.198|TWO_SIDED|95.0|-0.027|0.131|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|10 minutes pre-dose.(Week 24)||0.131|-0.027|0.1980
71038440|NCT01634139|141583929|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.078|STANDARD_ERROR_OF_MEAN|0.037||0.0344|TWO_SIDED|95.0|0.006|0.15|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|30 minutes post-dose (Week 24)||0.150|0.006|0.0344
71038441|NCT01634139|141583929|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.067|STANDARD_ERROR_OF_MEAN|0.037||0.0696|TWO_SIDED|95.0|-0.005|0.139|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|30 minutes post-dose (Week 24)||0.139|-0.005|0.0696
71038442|NCT01634139|141583929|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.109|STANDARD_ERROR_OF_MEAN|0.037||0.0032|TWO_SIDED|95.0|0.037|0.182|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|1 hour post-dose (week 24)||0.182|0.037|0.0032
71038443|NCT01634139|141583929|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.037||0.1044|TWO_SIDED|95.0|-0.012|0.132|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|1 hour post-dose (week 24)||0.132|-0.012|0.1044
71038444|NCT01634139|141583929|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.113|STANDARD_ERROR_OF_MEAN|0.037||0.0027|TWO_SIDED|95.0|0.039|0.186|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|2 hours post-dose (week 24)||0.186|0.039|0.0027
71038445|NCT01634139|141583929|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.093|STANDARD_ERROR_OF_MEAN|0.037||0.013|TWO_SIDED|95.0|0.02|0.166|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|2 hours post-dose (week 24)||0.166|0.020|0.0130
71038446|NCT01634139|141583929|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.115|STANDARD_ERROR_OF_MEAN|0.038||0.0025|TWO_SIDED|95.0|0.041|0.19|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|3 hours post-dose (week 24)||0.190|0.041|0.0025
70988392|NCT02749721|141485124|OTHER||F statistic|2.823||||0.101|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3b latencies at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.101
70988393|NCT02749721|141485124|OTHER||F statistic|0.806||||0.373|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P200 latencies at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.373
70988394|NCT02749721|141485124|OTHER||F statistic|1.822||||0.183|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P200 latencies at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.183
70988395|NCT02749721|141485124|OTHER||F statistic|0.516||||0.475|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P3a latencies at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.475
70988396|NCT02749721|141485124|OTHER||F statistic|0.214||||0.645|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P3a latencies at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.645
70988397|NCT02749721|141485125|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
70988398|NCT02749721|141485126|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
71038447|NCT01634139|141583929|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.092|STANDARD_ERROR_OF_MEAN|0.038||0.0156|TWO_SIDED|95.0|0.017|0.166|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|3 hours post-dose (Week 24)||0.166|0.017|0.0156
71038448|NCT01634139|141583930|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.165|STANDARD_ERROR_OF_MEAN|0.11||0.1349|TWO_SIDED|95.0|-0.382|0.051|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.051|-0.382|0.1349
70988399|NCT02749721|141485127|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
70988400|NCT02749721|141485128|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
70988401|NCT02749721|141485129|OTHER||Pearson's R|-0.044||||0.859|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and HDRS-28 baseline scores||||0.859
70988402|NCT02749721|141485129|OTHER||Pearson's R|-0.211||||0.451|TWO_SIDED||||||Pearson's correlation|||AOB P3a (amplitude)||||0.451
70988403|NCT02749721|141485129|OTHER||Pearson's R|0.015||||0.957|TWO_SIDED||||||Pearson's correlation|||AOB P3b (amplitude)||||0.957
70988404|NCT02749721|141485129|OTHER||Pearson's R|-0.322||||0.166|TWO_SIDED||||||Pearson's correlation|||VGNG P200 (amplitude)||||0.166
70988405|NCT02749721|141485129|OTHER||Pearson's R|-0.374||||0.105|TWO_SIDED||||||Pearson's correlation|||VGNG P3a (amplitude)||||0.105
70988406|NCT02749721|141485129|OTHER||Pearson's R|-0.137||||0.601|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and HDRS-28 baseline to endpoint percent change||||0.601
70988407|NCT02749721|141485129|OTHER||Pearson's R|-0.234||||0.421|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and HDRS-28 baseline to endpoint percent change||||0.421
70988408|NCT02749721|141485129|OTHER||Pearson's R|0.378||||0.316|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and HDRS-28 baseline to endpoint percent change||||0.316
70988409|NCT02749721|141485129|OTHER||Pearson's R|0.185||||0.478|TWO_SIDED||||||Pearson's correlation|||||||0.478
70988410|NCT02749721|141485129|OTHER||Pearson's R|0.011||||0.969|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and HDRS-28 baseline to endpoint percent change||||0.969
70988411|NCT02749721|141485129|OTHER||Pearson's R|-0.018||||0.943|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and HDRS-17 baseline scores||||0.943
70988412|NCT02749721|141485129|OTHER||Pearson's R|-0.074||||0.795|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and HDRS-17 baseline scores||||0.795
70988413|NCT02749721|141485129|OTHER||Pearson's R|-0.011||||0.969|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and HDRS-17 baseline scores||||0.969
70988414|NCT02749721|141485129|OTHER||Pearson's R|-0.197||||0.406|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and HDRS-17 baseline scores||||0.406
70988415|NCT02749721|141485129|OTHER||Pearson's R|-0.309||||0.185|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and HDRS-17 baseline scores||||0.185
70988416|NCT02749721|141485129|OTHER||Pearson's R|-0.195||||0.454|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and HDRS-17 baseline to endpoint percent change||||0.454
70988417|NCT02749721|141485129|OTHER||Pearson's R|-0.162||||0.579|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and HDRS-17 baseline to endpoint percent change||||0.579
70988418|NCT02749721|141485129|OTHER||Pearson's R|0.232||||0.549|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and HDRS-17 baseline to endpoint percent change||||0.549
71038449|NCT01634139|141583930|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.209|STANDARD_ERROR_OF_MEAN|0.11||0.0588|TWO_SIDED|95.0|-0.425|0.008|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.008|-0.425|0.0588
71098563|NCT01655069|141705525|OTHER||Adjusted change from baseline|1.72|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|1.27|2.16|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||2.16|1.27|
71098564|NCT01655069|141705525|OTHER||Adjusted change from baseline|1.8|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|1.36|2.24|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||2.24|1.36|
70988419|NCT02749721|141485129|OTHER||Pearson's R|0.169||||0.518|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and HDRS-17 baseline to endpoint percent change||||0.518
70988420|NCT02749721|141485129|OTHER||Pearson's R|0.027||||0.922|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and HDRS-17 baseline to endpoint percent change||||0.922
70988421|NCT02749721|141485129|OTHER||Pearson's R|-0.064||||0.796|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and QIDS-SR baseline scores||||0.796
70988422|NCT02749721|141485129|OTHER||Pearson's R|-0.506||||0.054|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and QIDS-SR baseline scores||||0.054
71038450|NCT01634139|141583930|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.154|STANDARD_ERROR_OF_MEAN|0.111||0.1675|TWO_SIDED|95.0|-0.372|0.065|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.065|-0.372|0.1675
71038451|NCT01634139|141583930|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.201|STANDARD_ERROR_OF_MEAN|0.111||0.0709|TWO_SIDED|95.0|-0.419|0.017|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.017|-0.419|0.0709
71098565|NCT01655069|141705525|OTHER||Adjusted change from baseline|2.21|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|1.74|2.67|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||2.67|1.74|
71098566|NCT01655069|141705525|OTHER||Adjusted change from baseline|2.28|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|95.0|1.79|2.77|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||2.77|1.79|
70988423|NCT02749721|141485129|OTHER||Pearson's R|0.002||||0.995|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and QIDS-SR baseline scores||||0.995
70988424|NCT02749721|141485129|OTHER||Pearson's R|0.102||||0.668|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and QIDS-SR baseline scores||||0.668
70988425|NCT02749721|141485129|OTHER||Pearson's R|0.037||||0.875|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and QIDS-SR baseline scores||||0.875
70988426|NCT02749721|141485129|OTHER||Pearson's R|-0.049||||0.852|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and QIDS-SR baseline to endpoint percent change||||0.852
70988427|NCT02749721|141485129|OTHER||Pearson's R|-0.34||||0.234|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and QIDS-SR baseline to endpoint percent change||||0.234
70988428|NCT02749721|141485129|OTHER||Pearson's R|0.655||||0.056|TWO_SIDED||||||Pearson's correlation|||||||0.056
70988429|NCT02749721|141485129|OTHER||Pearson's R|0.297||||0.248|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and QIDS-SR baseline to endpoint percent change||||0.248
70988430|NCT02749721|141485129|OTHER||Pearson's R|0.179||||0.507|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and QIDS-SR baseline to endpoint percent change||||0.507
71038452|NCT01634139|141583931|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.116|STANDARD_ERROR_OF_MEAN|0.065||0.0749|TWO_SIDED|95.0|-0.245|0.012|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.012|-0.245|0.0749
70988431|NCT02749721|141485129|OTHER||Pearson's R|0.049||||0.841|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and PDQ baseline scores||||0.841
70988432|NCT02749721|141485129|OTHER||Pearson's R|-0.185||||0.508|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and PDQ baseline scores||||0.508
70988433|NCT02749721|141485129|OTHER||Pearson's R|-0.03||||0.916|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and PDQ baseline scores||||0.916
70988434|NCT02749721|141485129|OTHER||Pearson's R|-0.345||||0.147|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and PDQ baseline scores||||0.147
70988435|NCT02749721|141485129|OTHER||Pearson's R|-0.284||||0.225|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and PDQ baseline scores||||0.225
70988436|NCT02749721|141485129|OTHER||Pearson's R|-0.044||||0.868|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and PDQ baseline to endpoint percent change||||0.868
70988437|NCT02749721|141485129|OTHER||Pearson's R|-0.18||||0.537|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and PDQ baseline to endpoint percent change||||0.537
70988438|NCT02749721|141485129|OTHER||Pearson's R|0.476||||0.195|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and PDQ baseline to endpoint percent change||||0.195
71038453|NCT01634139|141583931|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.141|STANDARD_ERROR_OF_MEAN|0.065||0.0305|TWO_SIDED|95.0|-0.269|-0.013|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||-0.013|-0.269|0.0305
70988439|NCT02749721|141485129|OTHER||Pearson's R|0.594||||0.015|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and PDQ baseline to endpoint percent change||||0.015
70988440|NCT02749721|141485129|OTHER||Pearson's R|-0.009||||0.972|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and PDQ baseline to endpoint percent change||||0.972
70988441|NCT02749721|141485129|OTHER||Pearson's R|0.067||||0.785|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and MGH-CPFQ baseline scores||||0.785
70988442|NCT02749721|141485129|OTHER||Pearson's R|-0.129||||0.646|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and MGH-CPFQ baseline scores||||0.646
70988443|NCT02749721|141485129|OTHER||Pearson's R|0.364||||0.182|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and MGH-CPFQ baseline scores||||0.182
70988444|NCT02749721|141485129|OTHER||Pearson's R|-0.414||||0.069|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and MGH-CPFQ baseline scores||||0.069
71038454|NCT01634139|141583931|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.125|STANDARD_ERROR_OF_MEAN|0.066||0.0581|TWO_SIDED|95.0|-0.255|0.004|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.004|-0.255|0.0581
71038455|NCT01634139|141583931|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.131|STANDARD_ERROR_OF_MEAN|0.066||0.0464|TWO_SIDED|95.0|-0.26|-0.002|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||-0.002|-0.260|0.0464
71098567|NCT01655069|141705525|OTHER||Adjusted change from baseline|2.84|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|95.0|2.19|3.49|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||3.49|2.19|
71098568|NCT01655069|141705525|OTHER||Adjusted change from baseline|1.53|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|0.17|2.89|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||2.89|0.17|
70988445|NCT02749721|141485129|OTHER||Pearson's R|-0.416||||0.068|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and MGH-CPFQ baseline scores||||0.068
70988446|NCT02749721|141485129|OTHER||Pearson's R|-0.023||||0.929|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and MGH-CPFQ baseline to endpoint percent change||||0.929
70988447|NCT02749721|141485129|OTHER||Pearson's R|-0.074||||0.802|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and MGH-CPFQ baseline to endpoint percent change||||0.802
70988448|NCT02749721|141485129|OTHER||Pearson's R|0.518||||0.153|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and MGH-CPFQ baseline to endpoint percent change||||0.153
70988449|NCT02749721|141485129|OTHER||Pearson's R|0.268||||0.298|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and MGH-CPFQ baseline to endpoint percent change||||0.298
70988450|NCT02749721|141485129|OTHER||Pearson's R|-0.001||||0.996|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and MGH-CPFQ baseline to endpoint percent change||||0.996
70988451|NCT02749721|141485129|OTHER||Pearson's R|0.242||||0.531|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and WLQ baseline scores||||0.531
70988452|NCT02749721|141485129|OTHER||Pearson's R|-0.598||||0.21|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and WLQ baseline scores||||0.210
70988453|NCT02749721|141485129|OTHER||Pearson's R|0.054||||0.899|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and WLQ baseline scores||||0.899
70988454|NCT02749721|141485129|OTHER||Pearson's R|0.568||||0.087|TWO_SIDED||||||Pearson's correlation|||||||0.087
70988455|NCT02749721|141485129|OTHER||Pearson's R|0.568||||0.087|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and WLQ baseline scores||||0.087
70988456|NCT02749721|141485129|OTHER||Pearson's R|0.231||||0.55|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and WLQ baseline to endpoint percent change||||0.550
70988457|NCT02749721|141485129|OTHER||Pearson's R|0.158||||0.766|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and WLQ baseline to endpoint percent change||||0.766
70988458|NCT02749721|141485129|OTHER||Pearson's R|-0.406||||0.498|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and WLQ baseline to endpoint percent change||||0.498
70988459|NCT02749721|141485129|OTHER||Pearson's R|0.221||||0.599|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and WLQ baseline to endpoint percent change||||0.599
70988460|NCT02749721|141485129|OTHER||Pearson's R|0.679||||0.064|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and WLQ baseline to endpoint percent change||||0.064
70988461|NCT02749721|141485130|OTHER||Pearson's R|-0.038||||0.881|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and HDRS-28 baseline scores||||0.881
70988462|NCT02749721|141485130|OTHER||Pearson's R|0.299||||0.279|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and HDRS-28 baseline scores||||0.279
70988463|NCT02749721|141485130|OTHER||Pearson's R|0.538||||0.039|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and HDRS-28 baseline scores||||0.039
70988464|NCT02749721|141485130|OTHER||Pearson's R|-0.018||||0.94|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and HDRS-28 baseline scores||||0.940
70988465|NCT02749721|141485130|OTHER||Pearson's R|0.107||||0.65|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and HDRS-28 baseline scores||||0.65
70988466|NCT02749721|141485130|OTHER||Pearson's R|0.247||||0.34|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and HDRS-28 baseline to endpoint percentage change||||0.340
70988467|NCT02749721|141485130|OTHER||Pearson's R|0.067||||0.819|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and HDRS-28 baseline to endpoint percentage change||||0.819
71038456|NCT01634139|141583932|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.096|STANDARD_ERROR_OF_MEAN|0.062||0.1182|TWO_SIDED|95.0|-0.217|0.025|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.025|-0.217|0.1182
71098569|NCT01655069|141705525|OTHER||Adjusted change from baseline|1.9|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|0.52|3.27|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||3.27|0.52|
71098570|NCT01655069|141705525|OTHER||Adjusted change from baseline|1.75|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|0.39|3.1|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||3.10|0.39|
70988468|NCT02749721|141485130|OTHER||Pearson's R|0.321||||0.4|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and HDRS-28 baseline to endpoint percentage change||||0.400
70988469|NCT02749721|141485130|OTHER||Pearson's R|0.279||||0.278|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and HDRS-28 baseline to endpoint percentage change||||0.278
70988470|NCT02749721|141485130|OTHER||Pearson's R|-0.136||||0.614|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and HDRS-28 baseline to endpoint percentage change||||0.614
70988471|NCT02749721|141485130|OTHER||Pearson's R|0.0||||0.999|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and HDRS-17 baseline scores||||0.999
70988472|NCT02749721|141485130|OTHER||Pearson's R|0.193||||0.491|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and HDRS-17 baseline scores||||0.491
70988473|NCT02749721|141485130|OTHER||Pearson's R|0.567||||0.028|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and HDRS-17 baseline scores||||0.028
70988474|NCT02749721|141485130|OTHER||Pearson's R|-0.03||||0.9|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and HDRS-17 baseline scores||||0.900
70988475|NCT02749721|141485130|OTHER||Pearson's R|0.141||||0.55|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and HDRS-17 baseline scores||||0.55
70988476|NCT02749721|141485130|OTHER||Pearson's R|0.231||||0.373|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and HDRS-17 baseline to endpoint percent change||||0.373
70988477|NCT02749721|141485130|OTHER||Pearson's R|0.019||||0.949|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and HDRS-17 baseline to endpoint percent change||||0.949
70988478|NCT02749721|141485130|OTHER||Pearson's R|0.122||||0.754|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and HDRS-17 baseline to endpoint percent change||||0.754
70988479|NCT02749721|141485130|OTHER||Pearson's R|0.176||||0.499|TWO_SIDED||||||0.176|||Correlation between VGNG P200 (latency) and HDRS-17 baseline to endpoint percent change||||0.499
70988480|NCT02749721|141485130|OTHER||Pearson's R|-0.162||||0.549|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and HDRS-17 baseline to endpoint percent change||||0.549
70988481|NCT02749721|141485130|OTHER||Pearson's R|-0.126||||0.617|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and QIDS-SR baseline scores||||0.617
70988482|NCT02749721|141485130|OTHER||Pearson's R|0.1||||0.722|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and QIDS-SR baseline scores||||0.722
70988483|NCT02749721|141485130|OTHER||Pearson's R|0.249||||0.371|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and QIDS-SR baseline scores||||0.371
70988484|NCT02749721|141485130|OTHER||Pearson's R|-0.072||||0.764|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and QIDS-SR baseline scores||||0.764
70988485|NCT02749721|141485130|OTHER||Pearson's R|-0.225||||0.34|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and QIDS-SR baseline scores||||0.34
70988486|NCT02749721|141485130|OTHER||Pearson's R|0.148||||0.57|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and QIDS-SR baseline to endpoint percent change||||0.570
70988487|NCT02749721|141485130|OTHER||Pearson's R|0.228||||0.434|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and QIDS-SR baseline to endpoint percent change||||0.434
70988488|NCT02749721|141485130|OTHER||Pearson's R|0.22||||0.569|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and QIDS-SR baseline to endpoint percent change||||0.569
70988489|NCT02749721|141485130|OTHER||Pearson's R|0.645||||0.005|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and QIDS-SR baseline to endpoint percent change||||0.005
70988490|NCT02749721|141485130|OTHER||Pearson's R|0.105||||0.698|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and QIDS-SR baseline to endpoint percent change||||0.698
70988491|NCT02749721|141485130|OTHER||Pearson's R|-0.073||||0.774|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and PDQ baseline scores||||0.774
70988492|NCT02749721|141485130|OTHER||Pearson's R|0.577||||0.024|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and PDQ baseline score||||0.024
70988493|NCT02749721|141485130|OTHER||Pearson's R|0.146||||0.603|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and PDQ baseline scores||||0.603
70988494|NCT02749721|141485130|OTHER||Pearson's R|-0.232||||0.326|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and PDQ baseline scores||||0.326
70988495|NCT02749721|141485130|OTHER||Pearson's R|0.098||||0.68|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and PDQ baseline scores||||0.68
70988496|NCT02749721|141485130|OTHER||Pearson's R|-0.073||||0.774|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and PDQ baseline to endpoint percent change||||0.774
70988497|NCT02749721|141485130|OTHER||Pearson's R|0.577||||0.024|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and PDQ baseline to endpoint percent change||||0.024
70988498|NCT02749721|141485130|OTHER||Pearson's R|0.146||||0.603|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and PDQ baseline to endpoint percent change||||0.603
70988499|NCT02749721|141485130|OTHER||Pearson's R|-0.232||||0.326|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and PDQ baseline to endpoint percent change||||0.326
70988500|NCT02749721|141485130|OTHER||Pearson's R|0.098||||0.68|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and PDQ baseline to endpoint percent change||||0.68
70988501|NCT02749721|141485130|OTHER||Pearson's R|-0.1||||0.692|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and MGH-CPFQ baseline scores||||0.692
70988502|NCT02749721|141485130|OTHER||Pearson's R|0.498||||0.059|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and MGH-CPFQ baseline scores||||0.059
70988503|NCT02749721|141485130|OTHER||Pearson's R|-0.332||||0.227|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and MGH-CPFQ baseline scores||||0.227
70988504|NCT02749721|141485130|OTHER||Pearson's R|-0.125||||0.6|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and MGH-CPFQ baseline scores||||0.600
71098571|NCT01655069|141705525|OTHER||Adjusted change from baseline|2.69|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|1.34|4.05|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||4.05|1.34|
71098572|NCT01655069|141705525|OTHER||Adjusted change from baseline|3.07|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|1.7|4.43|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||4.43|1.70|
70988505|NCT02749721|141485130|OTHER||Pearson's R|-0.096||||0.69|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and MGH-CPFQ baseline scores||||0.69
70988506|NCT02749721|141485130|OTHER||Pearson's R|0.259||||0.315|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and MGH-CPFQ baseline to endpoint percent change||||0.315
70988507|NCT02749721|141485130|OTHER||Pearson's R|0.002||||0.996|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and MGH-CPFQ baseline to endpoint percent change||||0.996
70988508|NCT02749721|141485130|OTHER||Pearson's R|0.234||||0.544|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and MGH-CPFQ baseline to endpoint percent change||||0.544
70988509|NCT02749721|141485130|OTHER||Pearson's R|0.455||||0.066|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and MGH-CPFQ baseline to endpoint percent change||||0.066
70988510|NCT02749721|141485130|OTHER||Pearson's R|-0.28||||0.293|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and MGH-CPFQ baseline to endpoint percent change||||0.293
70988511|NCT02749721|141485130|OTHER||Pearson's R|0.783||||0.013|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and WLQ baseline scores||||0.013
70988512|NCT02749721|141485130|OTHER||Pearson's R|0.135||||0.799|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and WLQ baseline scores||||0.799
70988513|NCT02749721|141485130|OTHER||Pearson's R|0.506||||0.201|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and WLQ baseline scores||||0.201
70988514|NCT02749721|141485130|OTHER||Pearson's R|-0.197||||0.586|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and WLQ baseline scores||||0.586
70988515|NCT02749721|141485130|OTHER||Pearson's R|-0.024||||0.95|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and WLQ baseline scores||||0.95
70988516|NCT02749721|141485130|OTHER||Pearson's R|0.039||||0.92|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and WLQ baseline to endpoint percent change||||0.920
70988517|NCT02749721|141485130|OTHER||Pearson's R|0.113||||0.831|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and WLQ baseline to endpoint percent change||||0.831
70988518|NCT02749721|141485130|OTHER||Pearson's R|0.655||||0.23|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and WLQ baseline to endpoint percent change||||0.230
70988519|NCT02749721|141485130|OTHER||Pearson's R|-0.602||||0.115|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and WLQ baseline to endpoint percent change||||0.115
70988520|NCT02749721|141485130|OTHER||Pearson's R|-0.313||||0.45|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and WLQ baseline to endpoint percent change||||0.450
70988521|NCT02137772|141485131|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-23.5|||<|0.0001|TWO_SIDED|95.0|-32.5|-14.6||A 1-sided p-value ≤0.0249 for the risk difference was used for declaring statistical significance|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||-14.6|-32.5|<0.0001
70988522|NCT02137772|141485132|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Nominal 2-sided p-value|Log Rank|The log rank test was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||||<0.0001
70988523|NCT02137772|141485133|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-31.3|||<|0.0001|TWO_SIDED|95.0|-39.9|-22.6||Nominal 1-sided p-value|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||-22.6|-39.9|<0.0001
70988524|NCT02137772|141485134|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-0.4||||0.4056|TWO_SIDED|95.0|-4.0|3.2||Nominal 1-sided p-value|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||3.2|-4.0|0.4056
70988525|NCT02137772|141485135|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-1.0||||0.2258|TWO_SIDED|95.0|-3.5|1.5||Nominal 1-sided p-value|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||1.5|-3.5|0.2258
70988526|NCT02137772|141485136|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-31.0|||<|0.0001|TWO_SIDED|95.0|-39.6|-22.4||Nominal 1-sided p-value|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||-22.4|-39.6|<0.0001
70988527|NCT02137772|141485137|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-23.3|||<|0.0001|TWO_SIDED|95.0|-32.3|-14.3||Nominal 1-sided p-value|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||-14.3|-32.3|<0.0001
70988528|NCT02137772|141485138|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Nominal 2-sided p-value|Log Rank|The log rank test analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||||<0.0001
70988529|NCT00418262|141485146|SUPERIORITY||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-0.21|0.3|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.30|-0.21|
70988530|NCT00418262|141485146|SUPERIORITY||Mean Difference (Net)|0.11|||||TWO_SIDED|95.0|-0.42|0.6|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.60|-0.42|
70988531|NCT00418262|141485147|SUPERIORITY||Mean Difference (Net)|0.12|||||TWO_SIDED|95.0|-0.11|0.39|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.39|-0.11|
70988532|NCT00418262|141485147|SUPERIORITY||Mean Difference (Net)|0.24|||||TWO_SIDED|95.0|-0.23|0.77|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.77|-0.23|
70988533|NCT00418262|141485148|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.17|0.36|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.36|-0.17|
70988534|NCT00418262|141485148|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.17|0.36|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.36|-0.17|
70988535|NCT00418262|141485149|SUPERIORITY||Mean Difference (Net)|0.13|||||TWO_SIDED|95.0|-0.16|0.4|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.40|-0.16|
71038457|NCT01634139|141583932|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.126|STANDARD_ERROR_OF_MEAN|0.061||0.0404|TWO_SIDED|95.0|-0.246|-0.006|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||-0.006|-0.246|0.0404
70988536|NCT00418262|141485149|SUPERIORITY||Mean Difference (Net)|0.13|||||TWO_SIDED|95.0|-0.16|0.4|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.40|-0.16|
71038458|NCT01634139|141583932|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.099|STANDARD_ERROR_OF_MEAN|0.062||0.1105|TWO_SIDED|95.0|-0.221|0.023|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.023|-0.221|0.1105
71038459|NCT01634139|141583932|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.103|STANDARD_ERROR_OF_MEAN|0.062||0.0983|TWO_SIDED|95.0|-0.224|0.019|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.019|-0.224|0.0983
70988537|NCT00418262|141485150|SUPERIORITY||Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-0.36|0.18|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.18|-0.36|
70988538|NCT00418262|141485150|SUPERIORITY||Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-0.36|0.18|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.18|-0.36|
70988539|NCT00418262|141485151|SUPERIORITY||Mean Difference (Net)|0.04|||||TWO_SIDED|95.0|-0.2|0.35|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.35|-0.20|
70988540|NCT00418262|141485151|SUPERIORITY||Mean Difference (Net)|0.04|||||TWO_SIDED|95.0|-0.2|0.35|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.35|-0.20|
71038460|NCT01634139|141583933|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.507|STANDARD_ERROR_OF_MEAN|5.387||0.1146|TWO_SIDED|95.0|-2.063|19.077|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||19.077|-2.063|0.1146
71038461|NCT01634139|141583933|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.493|STANDARD_ERROR_OF_MEAN|5.365||0.1628|TWO_SIDED|95.0|-3.034|18.02|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||18.020|-3.034|0.1628
71038462|NCT01634139|141583933|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.538|STANDARD_ERROR_OF_MEAN|5.435||0.3085|TWO_SIDED|95.0|-5.127|16.203|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||16.203|-5.127|0.3085
71038463|NCT01634139|141583933|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.774|STANDARD_ERROR_OF_MEAN|5.413||0.1053|TWO_SIDED|95.0|-1.847|19.394|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||19.394|-1.847|0.1053
71038464|NCT01634139|141583934|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.36|STANDARD_ERROR_OF_MEAN|5.451||0.0236|TWO_SIDED|95.0|1.663|23.056|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||23.056|1.663|0.0236
71038465|NCT01634139|141583934|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.146|STANDARD_ERROR_OF_MEAN|5.427||0.0093|TWO_SIDED|95.0|3.497|24.794|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||24.794|3.497|0.0093
71038466|NCT01634139|141583934|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.882|STANDARD_ERROR_OF_MEAN|5.497||0.7322|TWO_SIDED|95.0|-12.667|8.904|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||8.904|-12.667|0.7322
71038467|NCT01634139|141583934|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.176|STANDARD_ERROR_OF_MEAN|5.481||0.4463|TWO_SIDED|95.0|-6.578|14.929|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||14.929|-6.578|0.4463
71038468|NCT01634139|141583935|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.262|STANDARD_ERROR_OF_MEAN|1.039||0.8008|TWO_SIDED|95.0|-1.775|2.299|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||2.299|-1.775|0.8008
71038469|NCT01634139|141583935|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.166|STANDARD_ERROR_OF_MEAN|1.041||0.8731|TWO_SIDED|95.0|-1.875|2.208|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||2.208|-1.875|0.8731
71038470|NCT01634139|141583935|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.272|STANDARD_ERROR_OF_MEAN|1.058||0.7975|TWO_SIDED|95.0|-1.803|2.346|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||2.346|-1.803|0.7975
71038471|NCT01634139|141583935|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.579|STANDARD_ERROR_OF_MEAN|1.059||0.5845|TWO_SIDED|95.0|-2.656|1.498|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||1.498|-2.656|0.5845
71038472|NCT01634139|141583936|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.019|STANDARD_ERROR_OF_MEAN|0.048||0.6932|TWO_SIDED|95.0|-0.075|0.113|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.113|-0.075|0.6932
71038473|NCT01634139|141583936|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.065|STANDARD_ERROR_OF_MEAN|0.048||0.1741|TWO_SIDED|95.0|-0.158|0.029|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.029|-0.158|0.1741
70988541|NCT00418262|141485152|SUPERIORITY||Mean Difference (Net)|-0.03|||||TWO_SIDED|95.0|-0.24|0.24|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.24|-0.24|
70988542|NCT00418262|141485152|SUPERIORITY||Mean Difference (Net)|-0.06|||||TWO_SIDED|95.0|-0.49|0.49|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.49|-0.49|
70988543|NCT00418262|141485153|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.28|0.26|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.26|-0.28|
70988544|NCT00418262|141485153|SUPERIORITY||Mean Difference (Net)|-0.01|||||TWO_SIDED|95.0|-0.56|0.52|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.52|-0.56|
70988545|NCT00418262|141485154|SUPERIORITY||Mean Difference (Net)|-0.06|||||TWO_SIDED|95.0|-0.32|0.2|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.20|-0.32|
70988546|NCT00418262|141485154|SUPERIORITY||Median Difference (Net)|-0.12|||||TWO_SIDED|95.0|-0.64|0.39|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.39|-0.64|
70988547|NCT00418262|141485155|SUPERIORITY||Mean Difference (Net)|-0.05|||||TWO_SIDED|95.0|-0.28|0.24|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.24|-0.28|
70988548|NCT00418262|141485155|SUPERIORITY||Mean Difference (Net)|-0.09|||||TWO_SIDED|95.0|-0.57|0.47|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.47|-0.57|
70988549|NCT00418262|141485156|SUPERIORITY||Mean Difference (Net)|0.07|||||TWO_SIDED|95.0|-0.21|0.32|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.32|-0.21|
71038474|NCT01634139|141583936|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.024|STANDARD_ERROR_OF_MEAN|0.048||0.625|TWO_SIDED|95.0|-0.071|0.118|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.118|-0.071|0.6250
71038475|NCT01634139|141583936|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.015|STANDARD_ERROR_OF_MEAN|0.048||0.7597|TWO_SIDED|95.0|-0.109|0.08|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.080|-0.109|0.7597
71038476|NCT01634139|141583937|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.025|STANDARD_ERROR_OF_MEAN|0.05||0.6166|TWO_SIDED|95.0|-0.122|0.073|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.073|-0.122|0.6166
70988550|NCT00418262|141485156|SUPERIORITY||Mean Difference (Net)|0.07|||||TWO_SIDED|95.0|-0.21|0.32|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.32|-0.21|
70988551|NCT00418262|141485157|SUPERIORITY||Mean Difference (Net)|-0.11|||||TWO_SIDED|95.0|-0.36|0.13|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.13|-0.36|
70988552|NCT00418262|141485157|SUPERIORITY||Mean Difference (Net)|-0.22|||||TWO_SIDED|95.0|-0.72|0.27|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.27|-0.72|
70988553|NCT00418262|141485158|SUPERIORITY||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-0.19|0.35|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.35|-0.19|
70988554|NCT00418262|141485158|SUPERIORITY||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-0.19|0.35|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.35|-0.19|
70988555|NCT00418262|141485159|SUPERIORITY||Mean Difference (Net)|-7.4|||||TWO_SIDED|95.0|-7.76|-7.04|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||-7.04|-7.76|
70988556|NCT00418262|141485159|SUPERIORITY||Mean Difference (Net)|-2.44|||||TWO_SIDED|95.0|-3.03|-1.9|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||-1.90|-3.03|
71038477|NCT01634139|141583937|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.076|STANDARD_ERROR_OF_MEAN|0.049||0.1267|TWO_SIDED|95.0|-0.173|0.021|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.021|-0.173|0.1267
71098573|NCT01655069|141705525|OTHER||Adjusted change from baseline|2.45|STANDARD_ERROR_OF_MEAN|0.71|||TWO_SIDED|95.0|1.05|3.85|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||3.85|1.05|
71098574|NCT01655069|141705525|OTHER||Adjusted change from baseline|3.93|STANDARD_ERROR_OF_MEAN|0.81|||TWO_SIDED|95.0|2.34|5.53|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||5.53|2.34|
71038478|NCT01634139|141583937|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.006|STANDARD_ERROR_OF_MEAN|0.05||0.9|TWO_SIDED|95.0|-0.092|0.105|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.105|-0.092|0.9000
71038479|NCT01634139|141583937|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.05||0.3897|TWO_SIDED|95.0|-0.141|0.055|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.055|-0.141|0.3897
70988557|NCT00418262|141485160|SUPERIORITY||Mean Difference (Net)|0.39|||||TWO_SIDED|95.0|-0.69|1.38|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||1.38|-0.69|
70988558|NCT00418262|141485160|SUPERIORITY||Mean Difference (Net)|0.39|||||TWO_SIDED|95.0|-0.69|1.38|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||1.38|-0.69|
70988559|NCT05022004|141485202|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed|Mean Difference (Final Values)|0.31|||||TWO_SIDED|95.0|-0.28|0.91|||||The reported mean difference represents value for Left Eye at Week 2, 08:00am|||0.91|-0.28|
70988560|NCT05022004|141485202|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed|Mean Difference (Final Values)|0.19|||||TWO_SIDED|95.0|-0.39|0.76|||||The reported mean difference represents value for Right Eye at Week 2, 08:00am|||0.76|-0.39|
70988561|NCT05022004|141485202|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed|Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.59|0.5|||||The reported mean difference represents value for Left Eye at Week 6, 08:00am|||0.50|-0.59|
70988562|NCT05022004|141485202|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed|Mean Difference (Final Values)|-0.12|||||TWO_SIDED|95.0|-0.64|0.4|||||The reported mean difference represents value for Right Eye at Week 6, 08:00am|||0.40|-0.64|
70988563|NCT05022004|141485203|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed||||||0.0015||||||P value reported for Left Eye at Week 2; 08:00 am|two-sample t-test|||||||0.0015
70988564|NCT05022004|141485203|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed||||||0.0008|||||||two-sample t-test|P value reported for Right Eye at Week 2; 08:00am||||||0.0008
70988565|NCT05022004|141485203|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed|||||<|0.0001|||||||two-sample t-test|P value reported for left eye at week 6, 08:00 am||||||<.0001
70988566|NCT05022004|141485203|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed|||||<|0.0001|||||||two-sample t-test|P value reported for Right eye at Week 6; 08:00 am||||||<.0001
70988567|NCT01323673|141485237|SUPERIORITY_OR_OTHER|||||||0.151||95.0||||Cochran-Mantel-Haenszel (CMH) test stratified by center was used for analysis.|Cochran-Mantel-Haenszel|||||||0.151
70988568|NCT04598165|141485253|SUPERIORITY||Risk Ratio (RR)|1.25||||0.314|TWO_SIDED|95.0|0.81|1.92||The primary intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and taking into account a 10% attrition. Multiple imputation with chain equations (MICE) was used to impute missing values for any outcome with greater than 10% missingness. Any variables associated with the outcome or outcome missingness were included in the imputation model.||1.92|0.81|0.314
70988569|NCT04598165|141485254|SUPERIORITY||Risk Ratio (RR)|1.36||||0.217|TWO_SIDED|95.0|0.84|2.21||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and taking into account a 10% attrition. Multiple imputation with chain equations (MICE) was used to impute missing values for any outcome with greater than 10% missingness. Any variables associated with the outcome or outcome missingness were included in the imputation model.||2.21|0.84|0.217
70988570|NCT04598165|141485255|SUPERIORITY||Risk Ratio (RR)|1.04||||0.064|TWO_SIDED|95.0|1.0|1.08||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.05 in early initiation of breast feeding assuming 80% uptake in controls.||1.08|1.00|0.064
71098575|NCT01655069|141705526|OTHER||Adjusted change from baseline|-0.98|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-1.27|-0.69|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.69|-1.27|
71098576|NCT01655069|141705526|OTHER||Adjusted change from baseline|-1.15|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-1.44|-0.86|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"||-0.86|-1.44|
71098577|NCT01655069|141705526|OTHER||Adjusted change from baseline|-1.31|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-1.6|-1.02|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"||-1.02|-1.60|
71098578|NCT01655069|141705526|OTHER||Adjusted change from baseline|-1.22|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-1.51|-0.93|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"||-0.93|-1.51|
71098579|NCT01655069|141705526|OTHER||Adjusted change from baseline|-1.5|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-1.8|-1.21|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.21|-1.80|
71098580|NCT01655069|141705526|OTHER||Adjusted change from baseline|-1.52|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-1.83|-1.22|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.22|-1.83|
71098581|NCT01655069|141705526|OTHER||Adjusted change from baseline|-1.83|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-2.22|-1.43|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.43|-2.22|
71098582|NCT01655069|141705526|OTHER||Adjusted change from baseline|-0.93|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-1.73|-0.13|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.13|-1.73|
71098583|NCT01655069|141705526|OTHER||Adjusted change from baseline|-0.94|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-1.48|-0.4|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.40|-1.48|
71098584|NCT01655069|141705526|OTHER||Adjusted change from baseline|-0.81|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-1.46|-0.17|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.17|-1.46|
70988571|NCT04598165|141485256|SUPERIORITY||Risk Ratio (RR)|0.99||||0.363|TWO_SIDED|95.0|0.98|1.01||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.05 in exclusive breast feeding assuming 80% uptake in controls.||1.01|0.98|0.363
70988572|NCT04598165|141485257|SUPERIORITY||Risk Ratio (RR)|1.01||||0.093|TWO_SIDED|95.0|1.0|1.02||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.11 in application of substances to the cord or delaying first bath assuming 50% in controls.||1.02|1.00|0.093
70988573|NCT04598165|141485258|SUPERIORITY||Risk Ratio (RR)|1.03||||0.353|TWO_SIDED|95.0|0.97|1.09||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.11 in application of substances to the cord or delaying first bath assuming 50% in controls.||1.09|0.97|0.353
70988574|NCT04598165|141485259|SUPERIORITY||Risk Ratio (RR)|1.14||||0.751|TWO_SIDED|95.0|0.5|2.61||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.53 in provision of Kangaroo Mother Care assuming 25% in controls.||2.61|0.50|0.751
70988575|NCT04598165|141485260|SUPERIORITY||Risk Ratio (RR)|1.0||||0.431|TWO_SIDED|95.0|1.0|1.01||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson generalized estimating equations||n (%) are values at 6-week visit, and RR compares change over time for enrollment, 2- and 6-week visits. SMS group is the numerator.|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.04 in number of danger signs correctly named assuming median of 3 in controls.||1.01|1.00|0.431
70988576|NCT04598165|141485261|SUPERIORITY||Risk Ratio (RR)|1.03||||0.321|TWO_SIDED|95.0|0.98|1.08||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator.|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.11 in appropriate care seeking assuming 1 clinic visit in the 6-weeks postpartum for controls.||1.08|0.98|0.321
70988577|NCT04598165|141485262|SUPERIORITY||Risk Ratio (RR)|1.01||||0.65|TWO_SIDED|95.0|0.98|1.04||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson generalized estimating equations||n (%) are values at 6-week visit, and RR compares change over time for enrollment, 2- and 6-week visits. SMS group is the numerator.|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 0.76 in elevated depression symptoms assuming 19% in controls.||1.04|0.98|0.650
70988578|NCT04598165|141485263|SUPERIORITY||Coefficient|0.09||||0.071|TWO_SIDED|95.0|-0.007|0.18||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Linear generalized estimating equations||n (%) are values at 6-week visit, and RR compares change over time for enrollment, 2- and 6-week visits. SMS group is the numerator. Coefficient (95% CI) for linear GEE using enrollment, 2- and 6-week visits.|||0.18|-0.007|0.071
71038480|NCT01634139|141583938|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.072||0.0975|TWO_SIDED|95.0|-0.262|0.022|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.022|-0.262|0.0975
71038481|NCT01634139|141583938|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.182|STANDARD_ERROR_OF_MEAN|0.072||0.0116|TWO_SIDED|95.0|-0.323|-0.041|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||-0.041|-0.323|0.0116
71038482|NCT01634139|141583938|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.065|STANDARD_ERROR_OF_MEAN|0.073||0.3732|TWO_SIDED|95.0|-0.208|0.078|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.078|-0.208|0.3732
71038483|NCT01634139|141583938|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.093|STANDARD_ERROR_OF_MEAN|0.073||0.1985|TWO_SIDED|95.0|-0.236|0.049|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.049|-0.236|0.1985
71038484|NCT01634139|141583940|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.176|STANDARD_ERROR_OF_MEAN|0.072||0.0144|TWO_SIDED|95.0|0.035|0.316|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.316|0.035|0.0144
71038485|NCT01634139|141583940|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.127|STANDARD_ERROR_OF_MEAN|0.071||0.0747|TWO_SIDED|95.0|-0.013|0.267|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.267|-0.013|0.0747
70988579|NCT04598165|141485264|SUPERIORITY||Coefficient|0.02||||0.19|TWO_SIDED|95.0|-0.01|0.04||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Linear generalized estimating equations||n (%) are values at 6-week visit, and RR compares change over time for enrollment, 2- and 6-week visits. SMS group is the numerator. Coefficient (95% CI) for linear GEE using enrollment, 2- and 6-week visits.|||0.04|-0.01|0.190
70988580|NCT00426751|141485265|NON_INFERIORITY_OR_EQUIVALENCE|For the assessment of differences between both treatment groups, a generalized model (under binomial probability distribution), adjusted for center, was applied.|Median Difference (Final Values)|2.1||||||90.0|-8.5|12.8||||||||12.8|-8.5|
70988581|NCT00426751|141485266|NON_INFERIORITY_OR_EQUIVALENCE|For the assessment of differences between both treatment groups a generalised model (under binomial probability distribution), adjusted for centre, was applied.|Mean Difference (Final Values)|6.8||||||95.0|-3.0|16.6|||||Analysis based on the ITT population confirmed the results observed in the PP population.|||16.6|-3.0|
71038486|NCT01634139|141583940|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.021|STANDARD_ERROR_OF_MEAN|0.072||0.7654|TWO_SIDED|95.0|-0.163|0.12|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.120|-0.163|0.7654
71038487|NCT01634139|141583940|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.017|STANDARD_ERROR_OF_MEAN|0.072||0.8082|TWO_SIDED|95.0|-0.124|0.158|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.158|-0.124|0.8082
71038488|NCT01634139|141583941|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.175|STANDARD_ERROR_OF_MEAN|0.085||0.0392|TWO_SIDED|95.0|0.009|0.341|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.341|0.009|0.0392
71038489|NCT01634139|141583941|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.126|STANDARD_ERROR_OF_MEAN|0.084||0.1351|TWO_SIDED|95.0|-0.039|0.292|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.292|-0.039|0.1351
71038490|NCT01634139|141583941|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.018|STANDARD_ERROR_OF_MEAN|0.085||0.8291|TWO_SIDED|95.0|-0.185|0.149|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.149|-0.185|0.8291
71038491|NCT01634139|141583941|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.004|STANDARD_ERROR_OF_MEAN|0.085||0.9655|TWO_SIDED|95.0|-0.163|0.171|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.171|-0.163|0.9655
71038492|NCT01634139|141583942|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.191|STANDARD_ERROR_OF_MEAN|0.077||0.0139|TWO_SIDED|95.0|0.039|0.343|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.343|0.039|0.0139
70988582|NCT00747617|141485303|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Mixed Models Analysis|||||||<0.05
71038493|NCT01634139|141583942|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.125|STANDARD_ERROR_OF_MEAN|0.077||0.1043|TWO_SIDED|95.0|-0.026|0.276|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.276|-0.026|0.1043
71038494|NCT01634139|141583942|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.035|STANDARD_ERROR_OF_MEAN|0.078||0.6547|TWO_SIDED|95.0|-0.118|0.187|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.187|-0.118|0.6547
71038495|NCT01634139|141583942|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.077||0.3648|TWO_SIDED|95.0|-0.082|0.222|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.222|-0.082|0.3648
71098585|NCT01655069|141705526|OTHER||Adjusted change from baseline|-0.91|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-1.53|-0.28|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.28|-1.53|
71038496|NCT01634139|141583943|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.166|STANDARD_ERROR_OF_MEAN|0.074||0.0256|TWO_SIDED|95.0|0.02|0.312|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.312|0.020|0.0256
70988583|NCT02279524|141485305|SUPERIORITY||Difference in least square means|-3.09||||0.0655|TWO_SIDED|1.6|||||Mixed Models Analysis||||Post-Hoc Responder Analysis - was also carried out. See Post-Hoc analysis|||0.0655
70988584|NCT02279524|141485305|SUPERIORITY||Difference in least square means|-3.32||||0.045|TWO_SIDED|1.6|||||Mixed Models Analysis||||Post-Hoc Responder Analysis - was also carried out. See Post-Hoc analysis|||0.0450
71038497|NCT01634139|141583943|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.141|STANDARD_ERROR_OF_MEAN|0.074||0.0561|TWO_SIDED|95.0|-0.004|0.286|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.286|-0.004|0.0561
70988585|NCT02279524|141485306|SUPERIORITY||Odds Ratio (OR)|4.74||||0.0514|TWO_SIDED|95.0|0.99|22.66|||Regression, Logistic|The method used was a Baseline Adjusted Logistic Regression||||22.66|0.99|0.0514
70988586|NCT02279524|141485306|SUPERIORITY||Odds Ratio (OR)|1.79||||0.4955|TWO_SIDED|95.0|0.33|9.61|||Regression, Logistic|||||9.61|0.33|0.4955
70988587|NCT02279524|141485307|SUPERIORITY||Odds Ratio (OR)|1.88||||0.211|TWO_SIDED|95.0|0.7|5.04|||Regression, Logistic|||||5.04|0.70|0.2110
70988588|NCT02279524|141485307|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8425|TWO_SIDED|95.0|0.4|3.05|||Regression, Logistic|||||3.05|0.40|0.8425
70988589|NCT02279524|141485308|SUPERIORITY||Difference in least square means|-29.1|STANDARD_ERROR_OF_MEAN|6.4|<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||< 0.0001
70988590|NCT02279524|141485308|SUPERIORITY||Difference in least square means|-23.8|STANDARD_ERROR_OF_MEAN|6.3||0.0002|TWO_SIDED||||||Mixed Models Analysis|||||||0.0002
70988591|NCT02279524|141485309|SUPERIORITY||Difference in least square means|-0.447||||0.0008|TWO_SIDED|95.0|-0.7063|-0.1877|||Mixed Models Analysis|||||-0.1877|-0.7063|0.0008
70988592|NCT02279524|141485309|SUPERIORITY||Difference in least square means|-0.362||||0.0061|TWO_SIDED|95.0|-0.6196|-0.1043|||Mixed Models Analysis|||||-0.1043|-0.6196|0.0061
70988593|NCT02279524|141485310|SUPERIORITY||Difference in least square means|-17.5|STANDARD_ERROR_OF_MEAN|4.2|<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
70988594|NCT02279524|141485310|SUPERIORITY||Difference in least square means|-13.9|STANDARD_ERROR_OF_MEAN|4.2||0.0011|TWO_SIDED||||||Mixed Models Analysis|||||||0.0011
70988595|NCT02279524|141485311|SUPERIORITY||Odds Ratio (OR)|2.77||||0.0279|TWO_SIDED|95.0|1.11|6.88|||Mixed Models Analysis|||||6.88|1.11|0.0279
70988596|NCT02279524|141485311|SUPERIORITY||Odds Ratio (OR)|2.2||||0.0878|TWO_SIDED|95.0|0.89|5.46|||Regression, Logistic|||||5.46|0.89|0.0878
70988597|NCT02279524|141485312|SUPERIORITY||Odds Ratio (OR)|0.14||||0.1008|TWO_SIDED|95.0|0.01|1.46|||Regression, Logistic||This analysis is limited by low number of events, and the duration of the study.|||1.46|0.01|0.1008
70988598|NCT02279524|141485312|SUPERIORITY||Odds Ratio (OR)|0.63||||0.5693|TWO_SIDED|95.0|0.13|3.05|||Regression, Logistic||This analysis is limited by low number of events, and the duration of the study.|||3.05|0.13|0.5693
70988599|NCT00137436|141485333|SUPERIORITY_OR_OTHER|||||||0.942||95.0|||||Wilcoxon rank-sum test|||C1D14 : C1D1||||0.942
70988600|NCT00137436|141485333|SUPERIORITY_OR_OTHER|||||||0.323||95.0|||||Wilcoxon rank-sum test|||C2.D1 : C1D1||||0.323
70988601|NCT00137436|141485333|SUPERIORITY_OR_OTHER|||||||0.865||95.0|||||Wilcoxon rank-sum test|||C2.D14 : C1D1||||0.865
70988602|NCT00137436|141485333|SUPERIORITY_OR_OTHER|||||||0.873||95.0|||||Wilcoxon rank-sum test|||C3.D14 : C1D1||||0.873
70988603|NCT00137436|141485334|SUPERIORITY_OR_OTHER|||||||0.736||95.0|||||Wilcoxon rank-sum test|||C1D14 : C1D1||||0.736
70988604|NCT00137436|141485334|SUPERIORITY_OR_OTHER|||||||0.962||95.0|||||Wilcoxon rank-sum test|||C2.D1 : C1D1||||0.962
70988605|NCT00137436|141485334|SUPERIORITY_OR_OTHER|||||||0.185||95.0|||||Wilcoxon rank-sum test|||C2.D14 : C1D1||||0.185
70988606|NCT00137436|141485334|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon rank-sum test|||C3.D14 : C1D1||||1.000
70988607|NCT00137436|141485335|SUPERIORITY_OR_OTHER|||||||0.386||95.0|||||Wilcoxon rank-sum test|||C1D14 : C1D1||||0.386
70988608|NCT00137436|141485335|SUPERIORITY_OR_OTHER|||||||0.904||95.0|||||Wilcoxon rank-sum test|||C2.D1 : C1D1||||0.904
70988609|NCT00137436|141485335|SUPERIORITY_OR_OTHER|||||||0.812||95.0|||||Wilcoxon rank-sum test|||C2.D14 : C1D1||||0.812
70988610|NCT00137436|141485335|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||Wilcoxon rank-sum test|||C3.D14 : C1D1||||0.490
70988611|NCT00137436|141485336|SUPERIORITY_OR_OTHER|||||||0.839||95.0|||||Wilcoxon rank-sum test|||C1D14 : C1D1||||0.839
70988612|NCT00137436|141485336|SUPERIORITY_OR_OTHER|||||||0.219||95.0|||||Wilcoxon rank-sum test|||C2.D1 : C1D1||||0.219
70988613|NCT00137436|141485336|SUPERIORITY_OR_OTHER|||||||0.788||95.0|||||Wilcoxon rank-sum test|||C2.D14 : C1D1||||0.788
70988614|NCT00137436|141485336|SUPERIORITY_OR_OTHER|||||||0.164||95.0|||||Wilcoxon rank-sum test|||C3.D14 : C1D1||||0.164
70988615|NCT00137436|141485337|SUPERIORITY_OR_OTHER|||||||0.656||95.0|||||Wilcoxon rank-sum test|||C1D14 : C1D1||||0.656
70988616|NCT00137436|141485337|SUPERIORITY_OR_OTHER|||||||0.628||95.0|||||Wilcoxon rank-sum test|||C2.D1 : C1D1||||0.628
70988617|NCT00137436|141485337|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||Wilcoxon rank-sum test|||C2.D14 : C1D1||||0.420
70988618|NCT00137436|141485337|SUPERIORITY_OR_OTHER|||||||0.296||95.0|||||Wilcoxon rank-sum test|||C3.D14 : C1D1||||0.296
70988619|NCT00137436|141485338|SUPERIORITY_OR_OTHER|||||||0.903||95.0|||||Wilcoxon rank-sum test|||C1D14 : C1D1||||0.903
70988620|NCT00137436|141485338|SUPERIORITY_OR_OTHER|||||||0.434||95.0|||||Wilcoxon rank-sum test|||C2.D1 : C1D1||||0.434
70988621|NCT00137436|141485338|SUPERIORITY_OR_OTHER|||||||0.687||95.0|||||Wilcoxon rank-sum test|||C2.D14 : C1D1||||0.687
70988622|NCT00137436|141485338|SUPERIORITY_OR_OTHER|||||||0.296||95.0|||||Wilcoxon rank-sum test|||C3.D14 : C1D1||||0.296
70988623|NCT00738543|141485344|NON_INFERIORITY_OR_EQUIVALENCE|A minimal sample of 20 volunteers was calculated to to find a difference of 200 CFU/mL, with a power of 80% and bilateral error of 5%.|||||<|0.05||||||Post-hoc test of Kruskal-Wallis for multiple comparisons of Z values was used to determine which arm was different.|Kruskal-Wallis|2 degrees of freedom corrected for ties||The null hypothesis established that the three medians were equal. To test significant differences for non-normally distributed data, a range test (Kruskal-Wallis) was used.||||<0.05
71038498|NCT01634139|141583943|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.061|STANDARD_ERROR_OF_MEAN|0.075||0.4127|TWO_SIDED|95.0|-0.208|0.085|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.085|-0.208|0.4127
71038499|NCT01634139|141583943|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.074||0.8922|TWO_SIDED|95.0|-0.136|0.156|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.156|-0.136|0.8922
71038500|NCT01634139|141583945|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.009|STANDARD_ERROR_OF_MEAN|0.036||0.7931|TWO_SIDED|95.0|-0.08|0.061|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.061|-0.080|0.7931
71038501|NCT01634139|141583945|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.075|STANDARD_ERROR_OF_MEAN|0.036||0.0369|TWO_SIDED|95.0|-0.145|-0.005|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||-0.005|-0.145|0.0369
71038502|NCT01634139|141583945|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.036||0.4086|TWO_SIDED|95.0|-0.101|0.041|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.041|-0.101|0.4086
71038503|NCT01634139|141583945|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.026|STANDARD_ERROR_OF_MEAN|0.036||0.4714|TWO_SIDED|95.0|-0.097|0.045|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.045|-0.097|0.4714
71038504|NCT01634139|141583946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.001|STANDARD_ERROR_OF_MEAN|0.047||0.988|TWO_SIDED|95.0|-0.091|0.092|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.092|-0.091|0.9880
71038505|NCT01634139|141583946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.082|STANDARD_ERROR_OF_MEAN|0.046||0.0794|TWO_SIDED|95.0|-0.173|0.01|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.010|-0.173|0.0794
70988624|NCT00738543|141485346|NON_INFERIORITY_OR_EQUIVALENCE|The minimal sample of 20 volunteers was calculated to find a difference of 200 CFU/mL.|||||<|0.05||95.0||||Post-hoc test of Kruskal-Wallis for multiple comparisons of Z values was used to determine which arm was different.|Kruskal-Wallis|2 degrees of freedom corrected for ties||The null hypothesis established that the 3 medians were equal. To test significant differences for non-normally distributed data, a range test (Kruskal-Wallis) was used. The alpha level for significance was established at 5%. A minimal sample of 20 volunteers was calculated for a power of 80%, and bilateral error of 5%.||||<0.05
71098586|NCT01655069|141705526|OTHER||Adjusted change from baseline|-0.71|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-1.8|-0.38|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.38|-1.80|
71098587|NCT01655069|141705526|OTHER||Adjusted change from baseline|-1.18|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-1.92|-0.44|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.44|-1.92|
70988625|NCT05070429|141485400|SUPERIORITY||Maximum likelihood (MLE)|-0.035||||0.92|TWO_SIDED|95.0|-0.727|0.657||To account for the non-normal distribution of the outcome, confidence intervals and p-values were obtained using a bias corrected and accelerated bootstrap resampling procedure with 10,000 replicates.|generalized linear model (GLM)|generalized linear model (GLM) with an identity link|Confidence intervals and p-values were obtained using a bias-corrected and accelerated bootstrap resampling procedure with 10,000 replicates.|Used a weighted regression model with an identity link to compare average daily hours of hearing aid use at one-year post-randomization between participants assigned to the telehealth HHC or conventional HHC. Inverse probability of treatment weights will be calculated and included in the model for the primary outcome.||0.657|-0.727|0.92
70988626|NCT05070429|141485401|SUPERIORITY||Maximum likelihood (MLE)|-0.011||||0.87|TWO_SIDED|95.0|-0.147|0.125|||generalized linear model (GLM)||To account for the non-normal distribution of the outcome, confidence intervals and p-values were obtained using a bias corrected and accelerated bootstrap resampling procedure with 10,000 replicates.|Used a weighted regression model with an identity link to compare treatment satisfaction at one-year post-randomization between participants assigned to the telehealth HHC or conventional HHC. Inverse probability of treatment weights will be calculated and included in the model for the secondary outcome.||0.125|-0.147|0.87
70988627|NCT05070429|141485402|SUPERIORITY||Maximum likelihood (MLE)|0.059||||0.66|TWO_SIDED|95.0|-0.201|0.32|||generalized linear model (GLM)||To account for the non-normal distribution of the outcome, confidence intervals and p-values were obtained using a bias corrected and accelerated bootstrap resampling procedure with 10,000 replicates.|Used a weighted regression model with an identity link to compare primary COSI goal achievement at one-year post-randomization between participants assigned to the telehealth HHC or conventional HHC. Inverse probability of treatment weights will be calculated and included in the model for the secondary outcome.||0.320|-0.201|0.66
70988628|NCT05070429|141485403|SUPERIORITY||Maximum likelihood (MLE)|-1.96||||0.38|TWO_SIDED|95.0|-6.349|2.435|||generalized linear model (GLM)||To account for the non-normal distribution of the outcome, confidence intervals and p-values were obtained using a bias corrected and accelerated bootstrap resampling procedure with 10,000 replicates.|Used a weighted regression model with an identity link to compare hearing-specific quality of life at one-year post-randomization between participants assigned to the telehealth HHC or conventional HHC. Inverse probability of treatment weights will be calculated and included in the model for the secondary outcome.||2.435|-6.349|0.38
70988629|NCT00943319|141485406|OTHER||Median Survival time|161.0|||||TWO_SIDED|95.0|121.0|305.0|||Product limit survival estimate|||||305|121|
70988630|NCT00943319|141485407|OTHER||Median Disease Free Survival Time|172.0|||||TWO_SIDED|95.0|85.0|436.0||||||Estimated median survival time||436|85|
70988631|NCT02043301|141485408|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|120.96|||||TWO_SIDED|90.0|101.99|143.45|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed body weight as a covariate.||Thigh (Test) versus Abdomen (Reference)||143.45|101.99|
70988632|NCT02043301|141485408|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|94.93|||||TWO_SIDED|90.0|80.2|112.38|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed body weight as a covariate.||Upper Arm (Test) versus Abdomen (Reference)||112.38|80.20|
70988633|NCT02043301|141485409|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|127.65|||||TWO_SIDED|90.0|107.19|152.02|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed body weight as a covariate.||Thigh (Test) versus Abdomen (Reference)||152.02|107.19|
70988634|NCT02043301|141485409|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|86.16|||||TWO_SIDED|90.0|72.49|102.4|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed body weight as a covariate.||Upper Arm (Test) versus Abdomen (Reference)||102.40|72.49|
70988635|NCT02043301|141485410|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|129.98|||||TWO_SIDED|90.0|106.76|158.27|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed body weight as a covariate.||Thigh (Test) versus Abdomen (Reference)||158.27|106.76|
70988636|NCT02043301|141485410|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|100.27|||||TWO_SIDED|90.0|82.54|121.82|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed body weight as a covariate.||Upper Arm (Test) versus Abdomen (Reference)||121.82|82.54|
70988637|NCT02043301|141485415|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|97.35|||||TWO_SIDED|90.0|84.659|111.943|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||111.943|84.659|
70988638|NCT02043301|141485415|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|103.96|||||TWO_SIDED|90.0|90.405|119.557|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||119.557|90.405|
70988639|NCT02043301|141485416|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|97.1|||||TWO_SIDED|90.0|86.558|108.926|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||108.926|86.558|
70988640|NCT02043301|141485416|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|93.52|||||TWO_SIDED|90.0|83.359|104.912|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||104.912|83.359|
70988641|NCT02043301|141485417|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|97.1|||||TWO_SIDED|90.0|86.558|108.926|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||108.926|86.558|
70988642|NCT02043301|141485417|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|93.52|||||TWO_SIDED|90.0|83.359|104.912|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||104.912|83.359|
70988643|NCT02043301|141485419|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|102.51|||||TWO_SIDED|90.0|97.555|107.717|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||107.717|97.555|
71038506|NCT01634139|141583946|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.053|STANDARD_ERROR_OF_MEAN|0.047||0.2623|TWO_SIDED|95.0|-0.145|0.04|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.040|-0.145|0.2623
71038507|NCT01634139|141583946|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.047||0.3552|TWO_SIDED|95.0|-0.136|0.04|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.040|-0.136|0.3552
71038508|NCT01634139|141583947|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.039|STANDARD_ERROR_OF_MEAN|0.049||0.4359|TWO_SIDED|95.0|-0.135|0.058|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.058|-0.135|0.4359
71038509|NCT01634139|141583947|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.059|STANDARD_ERROR_OF_MEAN|0.049||0.2293|TWO_SIDED|95.0|-0.155|0.037|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.037|-0.155|0.2293
70988644|NCT02043301|141485419|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|102.02|||||TWO_SIDED|90.0|97.131|107.151|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||107.151|97.131|
70988645|NCT02043301|141485420|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|79.09|||||TWO_SIDED|90.0|60.883|102.735|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||102.735|60.883|
70988646|NCT02043301|141485420|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|91.15|||||TWO_SIDED|90.0|70.269|118.248|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||118.248|70.269|
70988647|NCT02043301|141485421|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|79.09|||||TWO_SIDED|90.0|60.883|102.735|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||102.735|60.883|
70988648|NCT02043301|141485421|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|91.15|||||TWO_SIDED|90.0|70.269|118.248|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||118.248|70.269|
71038510|NCT01634139|141583947|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.8372|TWO_SIDED|95.0|-0.108|0.088|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.088|-0.108|0.8372
71038511|NCT01634139|141583947|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.051|STANDARD_ERROR_OF_MEAN|0.049||0.3022|TWO_SIDED|95.0|-0.148|0.046|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.046|-0.148|0.3022
71038512|NCT01634139|141583948|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.031|STANDARD_ERROR_OF_MEAN|0.046||0.5004|TWO_SIDED|95.0|-0.122|0.06|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.060|-0.122|0.5004
71038513|NCT01634139|141583948|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.059|STANDARD_ERROR_OF_MEAN|0.046||0.1982|TWO_SIDED|95.0|-0.149|0.031|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.031|-0.149|0.1982
71038514|NCT01634139|141583948|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.012|STANDARD_ERROR_OF_MEAN|0.047||0.8019|TWO_SIDED|95.0|-0.103|0.08|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.080|-0.103|0.8019
71038515|NCT01634139|141583948|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.032|STANDARD_ERROR_OF_MEAN|0.046||0.4872|TWO_SIDED|95.0|-0.123|0.059|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.059|-0.123|0.4872
70988649|NCT00883558|141485438|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of INSULIN-PH20 NP to insulin lispro was supported if the upper limit of the one-sided 95% confidence interval for the difference in blood glucose between the treatments did not exceed 21.6 mg/dL.|LS Mean Difference|3.06||||0.3217|ONE_SIDED|95.0||14.11|||Mixed Models Analysis|Adjustments included treatment, phase, and treatment sequence as fixed effects and participant within treatment sequence as a random effect.||A total of at least 40 participants were to be enrolled in the study, and 30 participants were expected to complete both treatment cycles. Assuming a standard deviation for blood glucose of 45 milligrams per deciliter (mg/dL) and a true difference between the treatments of 0 mg/dL, the study had approximately 80% power to show that INSULIN-PH20 NP was non-inferior to insulin lispro with respect to the overall two-hour postprandial blood glucose excursion.||14.11||0.3217
70988650|NCT03703375|141485441|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.0541|TWO_SIDED|95.0|0.41|1.09|||Stratified Cox|Stratified Cox proportional hazards model||||1.09|0.41|0.0541
70988651|NCT03703375|141485442|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.0166|TWO_SIDED|95.0|0.32|0.96|||Efron|Stratified Cox proportional hazards model||||0.96|0.32|0.0166
70988652|NCT03703375|141485443|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.2139|TWO_SIDED|95.0|0.51|1.33|||Stratified Cox|Stratified Cox proportional hazards model||||1.33|0.51|0.2139
70988653|NCT00903032|141485477|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.003|TWO_SIDED||||||Chi-squared|||Unpaired t tests were used to compare continuous variables, and χ2 testswere used to compare categorical variables across the intervention and usual care. We used a log-rank test to compare the hazardof first hospitalization for MI, revascularization, or death.We used a Wilcoxon rank sum test to compare PDCs between study arms. For all other outcomes, χ2 tests and t testswere used for comparisons, as appropriate.||||0.003
70988654|NCT01703286|141485496|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|0.884||||0.5403|TWO_SIDED|90.0|0.633|1.235|||ANOVA|||||1.235|0.633|0.5403
70988655|NCT01703286|141485496|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|0.884||||0.5402|TWO_SIDED|90.0|0.632|1.235|||ANOVA|||||1.235|0.632|0.5402
70988656|NCT01703286|141485496|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|1.0||||0.9989|TWO_SIDED|90.0|0.715|1.397|||ANOVA|||||1.397|0.715|0.9989
70988657|NCT01703286|141485497|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|1.208||||0.3885|TWO_SIDED|90.0|0.84|1.738|||ANOVA|||||1.738|0.840|0.3885
70988658|NCT01703286|141485497|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|1.251||||0.3105|TWO_SIDED|90.0|0.868|1.801|||ANOVA|||||1.801|0.868|0.3105
70988659|NCT01703286|141485497|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|1.035||||0.8749|TWO_SIDED|90.0|0.721|1.485|||ANOVA|||||1.485|0.721|0.8749
70988660|NCT01703286|141485498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.048||0.2982|TWO_SIDED|90.0|-0.13|0.03|||ANOVA|||||0.030|-0.130|0.2982
70988661|NCT01703286|141485498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.021|STANDARD_ERROR_OF_MEAN|0.048||0.6601|TWO_SIDED|90.0|-0.059|0.101|||ANOVA|||||0.101|-0.059|0.6601
70988662|NCT01703286|141485498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.072|STANDARD_ERROR_OF_MEAN|0.048||0.1412|TWO_SIDED|90.0|-0.009|0.152|||ANOVA|||||0.152|-0.009|0.1412
70988663|NCT01984346|141485500|SUPERIORITY||Mean Difference (Net)|16.7||||0.0472|TWO_SIDED|95.0|0.1|33.2||A prior threshold for statistical significance was 0.05|Chi-square test|||||33.2|0.1|0.0472
70988664|NCT00972244|141485523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.0987|<|0.0001|TWO_SIDED|95.0|-0.67|-0.28||significant at alpha=0.015 (2-sided) applying Dunnett's adjustment. A sequential closed testing procedure was used to control Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.015 applying Dunnett's adjustment, two-sided)||-0.28|-0.67|<0.0001
70988665|NCT00972244|141485523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.1009|<|0.0001|TWO_SIDED|95.0|-0.65|-0.26||significant at alpha=0.015 (2-sided) applying Dunnett's adjustment. A sequential closed testing procedure was used to control Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.015 applying Dunnett's adjustment, two-sided)||-0.26|-0.65|<0.0001
70988666|NCT00972244|141485523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.099|<|0.0001|TWO_SIDED|95.0|-0.92|-0.53||significant at alpha=0.015 (2-sided) applying Dunnett's adjustment. A sequential closed testing procedure was used to control Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.015 applying Dunnett's adjustment, two-sided)||-0.53|-0.92|<0.0001
70988667|NCT00972244|141485523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.1018|<|0.0001|TWO_SIDED|95.0|-0.99|-0.59||significant at alpha=0.015 (2-sided) applying Dunnett's adjustment. A sequential closed testing procedure was used to control Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.015 applying Dunnett's adjustment, two-sided)||-0.59|-0.99|<0.0001
71038516|NCT01634139|141583949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.046||0.3498|TWO_SIDED|95.0|-0.135|0.048|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.048|-0.135|0.3498
71038517|NCT01634139|141583949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.106|STANDARD_ERROR_OF_MEAN|0.046||0.0222|TWO_SIDED|95.0|-0.196|-0.015|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||-0.015|-0.196|0.0222
71038518|NCT01634139|141583949|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.012|STANDARD_ERROR_OF_MEAN|0.047||0.799|TWO_SIDED|95.0|-0.104|0.08|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.080|-0.104|0.7990
70988668|NCT00972244|141485524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.08|STANDARD_ERROR_OF_MEAN|4.7589|<|0.0001|TWO_SIDED|95.0|-35.45|-16.7||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-16.70|-35.45|<0.0001
70988669|NCT00972244|141485524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.42|STANDARD_ERROR_OF_MEAN|4.71|<|0.0001|TWO_SIDED|95.0|-38.7|-20.14||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-20.14|-38.70|<0.0001
70988670|NCT00972244|141485524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.94|STANDARD_ERROR_OF_MEAN|4.7402|<|0.0001|TWO_SIDED|95.0|-42.28|-23.6||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-23.60|-42.28|<0.0001
70988671|NCT00972244|141485524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.37|STANDARD_ERROR_OF_MEAN|4.8358|<|0.0001|TWO_SIDED|95.0|-50.9|-31.85||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-31.85|-50.90|<0.0001
71038519|NCT01634139|141583949|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.035|STANDARD_ERROR_OF_MEAN|0.047||0.4586|TWO_SIDED|95.0|-0.126|0.057|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.057|-0.126|0.4586
71038520|NCT01634139|141583950|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.045|STANDARD_ERROR_OF_MEAN|0.056||0.4221|TWO_SIDED|95.0|-0.156|0.065|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.065|-0.156|0.4221
71038521|NCT01634139|141583950|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.093|STANDARD_ERROR_OF_MEAN|0.056||0.0959|TWO_SIDED|95.0|-0.204|0.017|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.017|-0.204|0.0959
71098588|NCT01655069|141705526|OTHER||Adjusted change from baseline|-1.79|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-2.59|-1.0|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.00|-2.59|
71098589|NCT01655069|141705527|OTHER||Adjusted change from baseline|-0.74|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.65|0.17|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||0.17|-1.65|
70988672|NCT00972244|141485525|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.2||||1|TWO_SIDED|95.0|-9.1|7.6||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|Fisher Exact|||H0: proportion(treat) minus proportion(placebo) = 0 versus HA: proportion(treat) minus proportion(placebo) =/= 0||7.6|-9.1|1.0000
70988673|NCT00972244|141485525|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.3||||0.2057|TWO_SIDED|95.0|-2.3|18.8||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|Fisher Exact|||H0: proportion(treat) minus proportion(placebo) = 0 versus HA: proportion(treat) minus proportion(placebo) =/= 0||18.8|-2.3|0.2057
71038522|NCT01634139|141583950|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.003|STANDARD_ERROR_OF_MEAN|0.057||0.9627|TWO_SIDED|95.0|-0.109|0.114|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.114|-0.109|0.9627
71098590|NCT01655069|141705527|OTHER||Adjusted change from baseline|-1.3|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-2.23|-0.36|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.36|-2.23|
70988674|NCT00972244|141485525|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.2||||0.6203|TWO_SIDED|95.0|-6.2|13.2||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|Fisher Exact|||H0: proportion(treat) minus proportion(placebo) = 0 versus HA: proportion(treat) minus proportion(placebo) =/= 0||13.2|-6.2|0.6203
71038523|NCT01634139|141583950|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.054|STANDARD_ERROR_OF_MEAN|0.057||0.3457|TWO_SIDED|95.0|-0.165|0.058|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.058|-0.165|0.3457
71038524|NCT01634139|141583951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.041|STANDARD_ERROR_OF_MEAN|0.043||0.3375|TWO_SIDED|95.0|-0.043|0.125|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.125|-0.043|0.3375
71098591|NCT01655069|141705527|OTHER||Adjusted change from baseline|-1.14|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-2.06|-0.22|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.22|-2.06|
70988675|NCT00972244|141485525|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.7||||0.205|TWO_SIDED|95.0|-2.0|19.5||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|Fisher Exact|||H0: proportion(treat) minus proportion(placebo) = 0 versus HA: proportion(treat) minus proportion(placebo) =/= 0||19.5|-2.0|0.2050
70988676|NCT03480282|141485529|OTHER|Because the observations were matched by the patient, we used the Wilcoxon signed-rank test, a nonparametric paired test|Mean Difference (Final Values)|2.5|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||This was a descriptive feasibility study.|This was an exploratory and descriptive study to learn if it was feasible to provide PCPs with their patients (aged 76-89) with information about their 10-year prognosis and engage in shared decision making around stopping screening. We measured among the 90 patients that the 45 PCPs saw whether their intentions to be screened declined after seeing their PCP.|This was a descriptive feasibility study.|||<0.001
70988677|NCT03480282|141485529|OTHER|This was a descriptive feasibility study.|Risk Difference (RD)|0.05|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This was a descriptive feasibility study.|Because the observations were matched by the patient, we used the Wilcoxon signed-rank test, a nonparametric paired test|||<0.001
70988678|NCT01234402|141485536|OTHER||Hazard Ratio (HR)|0.691||||0.1315|TWO_SIDED|95.0|0.429|1.114|||Log Rank|||Kaplan-Meier methodology estimated median PFS||1.114|0.429|0.1315
70988679|NCT01234402|141485536|OTHER||Hazard Ratio (HR)|1.48||||0.0851|TWO_SIDED|95.0|0.938|2.335|||Log Rank|||Kaplan-Meier methodology estimated median PFS||2.335|0.938|0.0851
70988680|NCT01234402|141485537|OTHER||Hazard Ratio (HR)|1.833||||0.0283|TWO_SIDED|95.0|1.06|3.169|||Log Rank|||||3.169|1.060|0.0283
71098592|NCT01655069|141705527|OTHER||Adjusted change from baseline|-1.28|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-2.18|-0.38|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.38|-2.18|
71098593|NCT01655069|141705527|OTHER||Adjusted change from baseline|-1.04|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.95|-0.12|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"||-0.12|-1.95|
71098594|NCT01655069|141705527|OTHER||Adjusted change from baseline|-1.96|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-2.93|-1.0|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.00|-2.93|
70988681|NCT01234402|141485537|OTHER||Hazard Ratio (HR)|1.468||||0.155|TWO_SIDED|95.0|0.862|2.501|||Log Rank|||||2.501|0.862|0.1550
70988682|NCT01234402|141485538|OTHER|||||||0.6691|||||||Fisher Exact|||||||0.6691
70988683|NCT01234402|141485538|OTHER|||||||0.1743|||||||Fisher Exact|||||||0.1743
70988684|NCT00374907|141485574|SUPERIORITY_OR_OTHER||Adjusted Percent Difference|18.5||||0.035|TWO_SIDED|95.0|1.3|38.7||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted percent difference for saxagliptin 5 mg vs placebo in Week 12 (LOCF) to baseline ratio. Adjusted for baseline.|ANCOVA model: logarithm(post/pre) = logarithm(pre) treatment|||38.7|1.3|0.0350
70988685|NCT00374907|141485575|SUPERIORITY_OR_OTHER||Adjusted Percent Difference|27.9||||0.0204|TWO_SIDED|95.0|4.2|57.1||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted percent difference for saxagliptin 5 mg vs placebo in Week 12 (LOCF) to baseline ratio. Adjusted for baseline.|ANCOVA model: logarithm(post/pre) = logarithm(pre) treatment|||57.1|4.2|0.0204
70988686|NCT00783705|141485592|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.39|TWO_SIDED|95.0|0.7|3.0|||Generalized estimating equation model|||Generalized estimating equation model on lesions (progressive disease vs. complete response/stable disease) was used to account for intra-patient correlation in the lesion-specific analysis.||3.0|0.7|0.39
70988687|NCT00783705|141485596|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CC-16 level between arms.||||0.10
70988688|NCT00783705|141485597|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker IL-6 level between arms.||||0.03
70988689|NCT00783705|141485598|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CCL-2 level between arms.||||0.58
70988690|NCT00783705|141485599|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker MPO level between arms.||||0.06
70988691|NCT00783705|141485600|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CC18 level between arms.||||0.63
70988692|NCT00783705|141485601|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker SFTPD level between arms.||||0.22
70988693|NCT00783705|141485602|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker Total Glutathione level between arms.||||0.06
70988694|NCT00783705|141485603|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CC-16 level between arms.||||0.35
70988695|NCT00783705|141485604|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CRP level between arms.||||0.80
70988696|NCT00783705|141485605|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker IL-6 level between arms.||||0.22
70988697|NCT00783705|141485606|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CCL-2 level between arms.||||0.74
70988698|NCT00783705|141485607|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker MPO level between arms.||||0.55
70988699|NCT00783705|141485608|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker Nitrotyrosine level between arms.||||0.91
70988700|NCT00783705|141485609|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CC18 level between arms.||||0.46
70988701|NCT00783705|141485610|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker SFTPD level between arms.||||0.52
70988702|NCT00576693|141485665|SUPERIORITY_OR_OTHER|||||||0.0252|||||||Log Rank|||The statistical analysis was based on a comparison of the of the two treatment groups with respect to the time to a primary outcome using the logrank test.||||0.0252
70988703|NCT00804193|141485666|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CI was constructed for the difference in the Therapeutic Success rates between the Test Product and Reference Product at Visit 4/Week 6 (Follow-Up). The interval was calculated using Wald's method with Yates' continuity correction. Therapeutic equivalence (bioequivalence) was established if this 90% CI was contained within the interval -0.20 to +0.20 (-20% to +20%).|Difference in Percentage of Participants|9.0|||||TWO_SIDED|90.0|-0.69|18.85|||Wald's method, Yates|CI calculated using Wald's method with Yates' continuity correction.|The sample size for this study was calculated assuming that both active treatments would have equivalent success proportions of at least 55% and the Vehicle would have a success proportion no greater than 25%.|||18.85|-0.69|
70988704|NCT00804193|141485667|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CI was constructed for the difference in the Success rates between the Test Product and Reference Product at Visit 4/Week 6 (Follow-Up). The interval was calculated using Wald's method with Yates' continuity correction. Bioequivalence was established if this 90% confidence interval was contained within the interval -0.20 to +0.20).|Difference in Percentage of Participants|1.0||||0.001|TWO_SIDED|90.0|-7.08|9.24|||Wald's method with Yates' continuity cor||The sample size for this study was calculated assuming that both active treatments would have equivalent success proportions of at least 55% and the Vehicle would have a success proportion no greater than 25%.|||9.24|-7.08|0.001
70988705|NCT00804193|141485668|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CI was constructed for the difference in the Success rates between the Test Product and Reference Product at Visit 4/Week 6 (Follow-Up). The interval was calculated using Wald's method with Yates' continuity correction. Bioequivalence was established if this 90% confidence interval was contained within the interval -0.20 to +0.20).|Difference in Percentage of Participants|4.0||||0.001|TWO_SIDED|90.0|-4.6|14.24|||Wald's method Yates' continuity cor||The sample size for this study was calculated assuming that both active treatments would have equivalent success proportions of at least 55% and the Vehicle would have a success proportion no greater than 25%.|||14.24|-4.60|0.001
71038525|NCT01634139|141583951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.037|STANDARD_ERROR_OF_MEAN|0.043||0.388|TWO_SIDED|95.0|-0.047|0.121|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.121|-0.047|0.3880
71038526|NCT01634139|141583951|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.019|STANDARD_ERROR_OF_MEAN|0.043||0.6541|TWO_SIDED|95.0|-0.066|0.104|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.104|-0.066|0.6541
71038527|NCT01634139|141583951|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.028|STANDARD_ERROR_OF_MEAN|0.043||0.5089|TWO_SIDED|95.0|-0.056|0.133|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.133|-0.056|0.5089
71038528|NCT01694563|141583952|SUPERIORITY|||||||0.05|||||||Fisher Exact|||The primary effectiveness hypothesis for this study was to demonstrate a superiority success rate at 36-months follow-up in patients treated with the AtriCure Synergy Ablation System compared to a pre-established performance goal.||||0.05
71038529|NCT01694563|141583953|SUPERIORITY||Clopper-Pearson|90.0|||||TWO_SIDED|90.0|||||||90% confidence interval calculated using the Clopper-Pearson method.|Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage at 12 months post-operatively.||||
71038530|NCT01694563|141583953|SUPERIORITY||Clopper-Pearson|90.0|||||TWO_SIDED|90.0|||||||90% confidence interval calculated using the Clopper-Pearson method.|Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage at 24 months post-operatively.||||
71038531|NCT01694563|141583953|SUPERIORITY||Clopper-Pearson|90.0|||||TWO_SIDED|90.0||||||||Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage at 36 months post-operatively.|90% confidence interval using the Clopper-Pearson method.|||
71038532|NCT01087502|141584029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.6|-0.24|||ANCOVA|||||-0.24|-0.60|<0.0001
71038533|NCT01087502|141584031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.29|STANDARD_ERROR_OF_MEAN|6.59||0.1602||95.0|-22.28|3.7|||ANCOVA|||||3.7|-22.28|0.1602
71098595|NCT01655069|141705527|OTHER||Adjusted change from baseline|-2.2|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|95.0|-3.48|-0.93|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.93|-3.48|
70988706|NCT01617434|141485669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19|||<|0.0001||95.0|-1.39|-0.99|||Mixed Models Analysis|||The null hypothesis of no difference between the two treatment arms with regard to changes from baseline in HbA1c (%) after 26 weeks of randomised treatment was analysed using a mixed model repeated measurements (MMRM) analysis with treatment, country, stratification groups as factors and baseline HbA1c as a covariate, all nested within visit.||-0.99|-1.39|<0.0001
71098596|NCT06399471|141705529|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.126||||||One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.|ANOVA|||An ANOVA was used to compare the Power Knee and the C-Leg 4.0 when used during Ten Meter Walking Test.||||0.126
71038534|NCT00985751|141584041|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The 95% CI for the difference between groups in the percentage of subjects with rectal temperature \> 40.0°C within the 7-day follow-up period following primary vaccination was computed for the Synflorix/GSK 2189242A Group minus Synflorix Group. No statistically significant difference between groups in rectal temperature \>40.0°C would be detected if the 95% CIs included 0 and non-inferiority would|Difference in percentage|0.97|||||TWO_SIDED|95.0|-6.1|5.32||||||Fever \>40°C-non-inferiority: To compare the 2 formulations of GSK Biologicals' S. pneumoniae protein containing vaccine (GSK 2189242A) combined with Synflorix™ vaccine (pooled groups) versus Synflorix™ vaccine (Synflorix/GSK 2189242A Group minus Synflorix Group) with respect to the percentage of subjects reporting fever \> 40.0°C (rectal temperature) within 7 days after at least 1 dose of primary vaccination.||5.32|-6.1|
71098597|NCT06399471|141705529|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.015|||||||ANOVA|||An ANOVA was used to compare the Power Knee and the Rheo when used during Ten Meter Walking Test.||||0.015
71098598|NCT06399471|141705529|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.852|||||||ANOVA|||An ANOVA was used to compare the Rheo and the C-Leg 4.0 when used during Ten Meter Walking Test.||||0.852
71038535|NCT00985751|141584042|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The 95% CI for the difference between groups in the percentage of subjects with rectal temperature \> 40.0°C within the 7-day follow-up period following primary vaccination was computed for the GSK 2189242A Group minus Synflorix Group. No statistically significant difference between groups in rectal temperature \>40.0°C would be detected if the 95% CIs included 0 and non-inferiority would be express|Difference in percentage|0.97|||||TWO_SIDED|95.0|-6.1|5.32||||||Fever \>40°C-non-inferiority: To compare the 2 formulations of GSK Biologicals' S. pneumoniae protein containing vaccine GSK 2189242A (pooled groups) versus Synflorix™ vaccine (GSK 2189242A Group minus Synflorix Group) with respect to the percentage of subjects reporting fever \> 40.0°C (rectal temperature) within 7 days after at least 1 dose of primary vaccination.||5.32|-6.1|
71098599|NCT06399471|141705530|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary||||||0.003|||||||ANOVA|||An ANOVA was used to compare the Power Knee and the C-Leg 4.0 when used during Two Meter Walking Test.||||0.003
71098600|NCT06399471|141705530|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary||||||0.027|||||||ANOVA|||An ANOVA was used to compare the Power Knee and the Rheo when used during Two Meter Walking Test.||||0.027
71098601|NCT06399471|141705530|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary||||||0.425|||||||ANOVA|||An ANOVA was used to compare the Rheo and the C-Leg 4.0 when used during Two Meter Walking Test.||||0.425
71098602|NCT06399471|141705531|OTHER|Non-parametric Friedman's test with multiple comparison correction||||||0.006|||||||Non-parametric Friedman's test with mult|||The Non-parametric Friedman's test was used to compare the survey results between the participants using the Power Knee and the C-Leg 4.0.||||0.006
71098603|NCT06399471|141705531|OTHER|Non-parametric Friedman's test with multiple comparison correction||||||0.236|||||||Non-parametric Friedman's test with mult|||The Non-parametric Friedman's test was used to compare the survey results between the participants using the Power Knee and the Rheo.||||0.236
71098604|NCT06399471|141705531|OTHER|Non-parametric Friedman's test with multiple comparison correction||||||0.118|||||||Non-parametric Friedman's test with mult|||The Non-parametric Friedman's test was used to compare the survey results between the participants using the Rheo and the C-Leg 4.0.||||0.118
70988707|NCT01617434|141485670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28|||<|0.0001||95.0|-1.7|-0.86|||Mixed Models Analysis|||The response was analysed using a mixed model repeated measurements (MMRM) analysis with treatment, country, stratification groups as factors and baseline as a covariate, all nested within visit.||-0.86|-1.70|<0.0001
70988708|NCT01617434|141485671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.59|||<|0.0001||95.0|-2.01|-1.18|||Mixed Models Analysis|||The response was analysed using a mixed model repeated measurements (MMRM) analysis with treatment, country, stratification groups as factors and baseline as a covariate, all nested within visit.||-1.18|-2.01|<0.0001
71038536|NCT00380588|141584054|SUPERIORITY_OR_OTHER|||||||0.38||95.0||||P-value for response (Complete Response + Partial Response).|Fisher Exact|||||||0.380
71038537|NCT00380588|141584055|SUPERIORITY_OR_OTHER|||||||0.074||95.0|||||Log Rank|||||||0.074
71098605|NCT06399471|141705532|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.687|||||||ANOVA|||An ANOVA was used to compare the Power Knee, the C-Leg 4.0, and the Rheo when used during Stance Time Asymmetry Index test.||||0.687
71098606|NCT06399471|141705533|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.082|||||||ANOVA|||An ANOVA was used to compare the Power Knee, the C-Leg 4.0, and Rheo when used during the Narrowing beam walking test.||||0.082
70988709|NCT01617434|141485672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.11|||<|0.0001||95.0|-3.85|-2.37|||Mixed Models Analysis|||The response was analysed using a mixed model repeated measurements (MMRM) analysis with treatment, country, stratification groups as factors and baseline as a covariate, all nested within visit.||-2.37|-3.85|<0.0001
70988710|NCT01617434|141485673|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.91|||<|0.0001||95.0|5.45|14.59|||Regression, Logistic|||This endpoint was analysed using a logistic regression model with treatment and stratification factors as fixed factors and the HbA1c value at baseline as a covariate. Subjects previously treated with insulin detemir without the use of metformin were not included in the analysis due to the small size of the stratum.||14.59|5.45|<0.0001
70988711|NCT01617434|141485674|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.12|||<|0.0001||95.0|9.92|40.84|||Regression, Logistic|||This endpoint was analysed using a logistic regression model with treatment and stratification factors as fixed factors and the HbA1c value at baseline as a covariate. Subjects previously treated with insulin detemir without the use of metformin were not included in the analysis due to the small size of the stratum.||40.84|9.92|<0.0001
70988712|NCT03283163|141485691|OTHER|||||||0.04|||||||t-test, 2 sided|||paired samples t-test to compare PTSD severity from baseline to endpoint (week 13).||||.040
71038538|NCT00380588|141584056|SUPERIORITY_OR_OTHER|||||||0.136||95.0|||||Log Rank|||||||0.136
71038539|NCT01451541|141584058|SUPERIORITY_OR_OTHER||LS Means with adjusted pvalues|0.59|||<|0.05||||||Multiple comparisons were adjusted for the primary and key secondary endpoints|Bonferroni-based gatekeeping method|Bonferroni-based gatekeeping method was used for multiple comparison adjustment.||Using an estimate of the standard deviation of 2.2 for the change from baseline in daily average subject-reported AM and PM rTNSS averaged over the first 6 weeks of double-blind treatment, 284 subjects per treatment group would have provided 90% power to detect a mean difference between treatment groups of 0.6 in the change from baseline with a 2-sided significance level of 0.05. Approx. 852 subjects were randomly assigned in a 1:1:1 ratio (ie, approximately 284 subjects per treatment group).||||<0.05
71038540|NCT01451541|141584058|SUPERIORITY_OR_OTHER||LS Means with adjusted p-values.|0.47|||<|0.05||||||Multiple comparisons were adjusted for the primary and key secondary endpoints|Bonferroni-based gatekeeping method|Bonferroni-based gatekeeping method was used for multiple comparison adjustment.||Using an estimate of the standard deviation of 2.2 for the change from baseline in daily average subject-reported AM and PM rTNSS averaged over the first 6 weeks of double-blind treatment, 284 subjects per treatment group would have provided 90% power to detect a mean difference between treatment groups of 0.6 in the change from baseline with a 2-sided significance level of 0.05. Approx. 852 subjects were randomly assigned in a 1:1:1 ratio (ie, approximately 284 subjects per treatment group).||||<0.05
71038541|NCT01120028|141584100|OTHER||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.28|0.64|||Log Rank|||||0.64|0.28|<0.0001
71038542|NCT01120028|141584101|OTHER|||||||0.5|||||||ANCOVA|||||||0.5
71038543|NCT01120028|141584102|OTHER||Hazard Ratio (HR)|1.23||||0.58|TWO_SIDED|95.0|0.59|2.55|||Regression, Cox|||||2.55|0.59|0.58
71038544|NCT01120028|141584103|OTHER||Rate Ratio|1.99||||0.23|TWO_SIDED|95.0|0.64|6.18|||Log Rank|||||6.18|0.64|0.23
71098607|NCT06399471|141705534|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.943|||||||ANOVA|||An ANOVA was used to compare the reported falls when for when the Power Knee, C-Leg 4.0, and the Rheo were used.||||0.943
70988713|NCT03283163|141485692|OTHER|||||||0.69|||||||t-test, 2 sided|||paired samples t-test to compare degree of pain-related interference from baseline to endpoint (week 13).||||.69
70988714|NCT03283163|141485693|OTHER|||||||0.098|||||||t-test, 2 sided|||paired samples t-test to compare severity of pain catastrophizing from baseline to endpoint (week 13).||||.098
71038545|NCT01120028|141584104|OTHER||Rate Ratio|1.02||||0.88|TWO_SIDED|95.0|0.8|1.29|||Regression, Cox|||||1.29|0.80|0.88
71038546|NCT01120028|141584105|OTHER||Rate ratio|1.51||||0.008|TWO_SIDED|95.0|1.11|2.06|||Log Rank|||||2.06|1.11|0.008
70988715|NCT03283163|141485694|OTHER|||||||0.194|||||||t-test, 2 sided|||paired samples t-tests were conducted for comparison of resting ALLO+PA levels from baseline to endpoint (week 13).||||.194
70988716|NCT03283163|141485695|OTHER|paired samples t-test||||||0.343|||||||t-test, 2 sided|||paired samples t-tests were conducted for comparison of peak ALLO+PA levels (30 minutes post MAXEX) from baseline to endpoint (week 13).||||.343
70988717|NCT04238663|141485696|EQUIVALENCE|"Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25.~The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of Geometric Least Square Mean|1.06|||||TWO_SIDED|90.0|0.976|1.16|||||For the comparison, MB02 represents the numerator and EU Avastin represents the denominator.|||1.16|0.976|
70988718|NCT04238663|141485696|EQUIVALENCE|"Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25.~The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of Geometric Least Square Mean|0.983|||||TWO_SIDED|90.0|0.897|1.08||||||For the comparison, MB02 represents the numerator and US Avastin represents the denominator.||1.08|0.897|
70988719|NCT04238663|141485696|EQUIVALENCE|"Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25.~The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of Geometric Least Square Mean|0.926|||||TWO_SIDED|90.0|0.851|1.01|||||For Ratio of geometric least square mean (GLSM): EU is the numerator and US Avastin acts as the denominator|||1.01|0.851|
71038547|NCT01120028|141584106|OTHER||Rate Ratio|1.0||||0.99|TWO_SIDED|95.0|0.51|1.97|||Log Rank|||||1.97|0.51|0.99
71038548|NCT01120028|141584107|OTHER||Rate Ratio|0.76||||0.52|TWO_SIDED|95.0|0.34|1.73|||Log Rank|||||1.73|0.34|0.52
71098608|NCT06399471|141705535|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.535|||||||ANOVA|||An ANOVA was used to compare the Physiological cost index for when the Power Knee, the C-Leg 4.0, and the Rheo were used.||||0.535
70988720|NCT04238663|141485697|EQUIVALENCE|"Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25.~The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|1.07|||||TWO_SIDED|90.0|1.0|1.14|||||For the comparison, MB02 represents the numerator and EU Avastin represents the denominator|||1.14|1.00|
70988721|NCT04238663|141485697|EQUIVALENCE|"Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25.~The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|0.998|||||TWO_SIDED|90.0|0.944|1.05|||||For the comparison, MB02 represents the numerator and US Avastin represents the denominator.|||1.05|0.944|
70988722|NCT04238663|141485697|EQUIVALENCE|"Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25.~The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|0.934|||||TWO_SIDED|90.0|0.884|0.988|||||EU Avastin corresponds to the numerator and US Avastin corresponds to the denominator|||0.988|0.884|
70988723|NCT03596177|141485704|SUPERIORITY||Mean Difference (Net)|-2.58||||0.011|TWO_SIDED|90.0|-4.15|-1.0|||ANCOVA|||||-1.00|-4.15|0.011
70988724|NCT03596177|141485705|SUPERIORITY||Mean Difference (Net)|-45.481||||0.002|TWO_SIDED|90.0|-67.777|-23.186|||ANCOVA|||Statistical Analysis for Day 32||-23.186|-67.777|0.002
70988725|NCT03596177|141485705|SUPERIORITY||Mean Difference (Net)|-41.323||||0.011|TWO_SIDED|90.0|-66.74|-15.907|||ANCOVA|||Statistical Analysis for Day 59||-15.907|-66.740|0.011
70988726|NCT03596177|141485706|SUPERIORITY||Mean Difference (Net)|-1551.194|||<|0.001|TWO_SIDED|90.0|-2190.515|-911.873|||ANCOVA|||Statistical Analysis for Day 32||-911.873|-2190.515|<0.001
70988727|NCT03596177|141485706|SUPERIORITY||Mean Difference (Net)|-1332.515||||0.015|TWO_SIDED|90.0|-2187.711|-477.318|||ANCOVA|||Statistical Analysis for Day 59||-477.318|-2187.711|0.015
70988728|NCT03596177|141485707|SUPERIORITY||Mean Difference (Net)|-3.173||||0.384|TWO_SIDED|90.0|-9.368|3.022|||ANCOVA|||||3.022|-9.368|0.384
70988729|NCT03596177|141485708|SUPERIORITY||Mean Difference (Net)|-10.039||||0.351|TWO_SIDED|90.0|-28.287|8.209|||ANCOVA|||||8.209|-28.287|0.351
70988730|NCT03596177|141485709|SUPERIORITY||Mean Difference (Net)|0.186||||0.968|TWO_SIDED|90.0|-7.858|8.229|||ANCOVA|||||8.229|-7.858|0.968
70988731|NCT03596177|141485710|SUPERIORITY||Mean Difference (Net)|0.867||||0.58|TWO_SIDED|90.0|-1.81|3.545|||ANCOVA|||||3.545|-1.810|0.580
70988732|NCT03596177|141485711|SUPERIORITY||Mean Difference (Net)|-3.645||||0.324|TWO_SIDED|90.0|-9.894|2.603|||ANCOVA|||||2.603|-9.894|0.324
70988733|NCT03596177|141485712|SUPERIORITY||Mean Difference (Net)|-5.672||||0.412|TWO_SIDED|90.0|-17.415|6.072|||ANCOVA|||||6.072|-17.415|0.412
70988734|NCT03596177|141485713|SUPERIORITY||Mean Difference (Net)|7.357||||0.177|TWO_SIDED|90.0|-1.742|16.456|||ANCOVA|||||16.456|-1.742|0.177
70988735|NCT03596177|141485714|SUPERIORITY||Mean Difference (Net)|15.186||||0.168|TWO_SIDED|90.0|-3.151|33.523|||ANCOVA|||||33.523|-3.151|0.168
70988736|NCT03596177|141485715|SUPERIORITY||Mean Difference (Net)|-2.54||||0.009|TWO_SIDED|90.0|-4.05|-1.03|||ANCOVA|||||-1.03|-4.05|0.009
70988737|NCT03596177|141485716|SUPERIORITY||Mean Difference (Net)|-5.122||||0.107|TWO_SIDED|90.0|-10.364|0.119|||ANCOVA|||||0.119|-10.364|0.107
70988738|NCT03596177|141485717|SUPERIORITY||Mean Difference (Net)|-1.848||||0.085|TWO_SIDED|90.0|-3.605|-0.091|||ANCOVA|||||-0.091|-3.605|0.085
70988739|NCT03596177|141485718|SUPERIORITY||Mean Difference (Net)|-3.159||||0.204|TWO_SIDED|90.0|-7.326|1.007|||ANCOVA|||||1.007|-7.326|0.204
70988740|NCT03596177|141485719|SUPERIORITY||Mean Difference (Net)|-0.019||||0.145|TWO_SIDED|90.0|-0.041|0.003|||ANCOVA|||||0.003|-0.041|0.145
70988741|NCT03596177|141485720|SUPERIORITY||Mean Difference (Net)|-26.001||||0.001|TWO_SIDED|90.0|-37.801|-14.201|||ANCOVA|||||-14.201|-37.801|0.001
70988742|NCT03596177|141485721|SUPERIORITY||Mean Difference (Net)|-12.332||||0.01|TWO_SIDED|90.0|-19.726|-4.938|||ANCOVA|||||-4.938|-19.726|0.010
70988743|NCT00968253|141485735|SUPERIORITY_OR_OTHER||Maximum tolerated dose|5.0|||||TWO_SIDED||||||||Maximum tolerated dose (MTD) of Everolimus measured in mg/day in combination with HyperCVAD|||||
70988744|NCT01301742|141485738|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa and gemfibrozil divided by empa alone|Geometric Mean Ratio|158.5|STANDARD_DEVIATION|7.5|||TWO_SIDED|90.0|151.77|165.53|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the intra-individual geometric coefficient of variation (gCV)|||165.53|151.77|
70988745|NCT01301742|141485739|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa and gemfibrozil divided by empa alone|Geometric Mean Ratio|115.0|STANDARD_DEVIATION|13.8|||TWO_SIDED|90.0|106.15|124.59|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the intra-individual gCV|||124.59|106.15|
70988746|NCT01301742|141485740|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa and gemfibrozil divided by empa alone|Geometric Mean Ratio|158.29|STANDARD_DEVIATION|7.7|||TWO_SIDED|90.0|151.41|165.49|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the intra-individual gCV|||165.49|151.41|
70988747|NCT04657016|141485748|SUPERIORITY||Mean Difference (Net)|-24.5|||<|0.001|TWO_SIDED|95.0|-26.1|-22.8|||Mixed Models Analysis|||||-22.8|-26.1|<0.001
70988748|NCT04657016|141485749|SUPERIORITY||Odds Ratio (OR)|130.36|||<|0.001|TWO_SIDED|95.0|69.98|242.84|||Regression, Logistic|||||242.84|69.98|<0.001
70988749|NCT04657016|141485750|SUPERIORITY||Odds Ratio (OR)|101.6|||<|0.001|TWO_SIDED|95.0|39.17|263.55|||Regression, Logistic|||||263.55|39.17|<0.001
70988750|NCT04657016|141485751|SUPERIORITY||Odds Ratio (OR)|153.95|||<|0.001|TWO_SIDED|95.0|78.9|300.37|||Regression, Logistic|||||300.37|78.90|<0.001
70988751|NCT04657016|141485752|SUPERIORITY||Odds Ratio (OR)|144.48|||<|0.001|TWO_SIDED|95.0|62.65|333.21|||Regression, Logistic|||||333.21|62.65|<0.001
70988752|NCT04657016|141485753|SUPERIORITY||Odds Ratio (OR)|118.06|||<|0.001|TWO_SIDED|95.0|40.08|347.74|||Regression, Logistic|||||347.74|40.08|<0.001
70988753|NCT04657016|141485754|SUPERIORITY||Mean Difference (Net)|-17.9|||<|0.001|TWO_SIDED|95.0|-19.5|-16.3|||Mixed Models Analysis|||||-16.3|-19.5|<0.001
70988754|NCT04657016|141485755|SUPERIORITY||Mean Difference (Net)|-25.0|||<|0.001|TWO_SIDED|95.0|-26.9|-23.2|||Mixed Models Analysis|||||-23.2|-26.9|<0.001
70988755|NCT04657016|141485756|SUPERIORITY||Mean Difference (Net)|-8.9|||<|0.001|TWO_SIDED|95.0|-9.6|-8.3|||Mixed Models Analysis|||||-8.3|-9.6|<0.001
70988756|NCT04657016|141485757|SUPERIORITY||Mean Difference (Net)|-10.2|||<|0.001|TWO_SIDED|95.0|-12.2|-8.1|||Mixed Models Analysis|||||-8.1|-12.2|<0.001
70988757|NCT04657016|141485758|SUPERIORITY||Mean Difference (Net)|-5.7|||<|0.001|TWO_SIDED|95.0|-7.2|-4.3|||Mixed Models Analysis|||||-4.3|-7.2|<0.001
70988758|NCT04657016|141485759|SUPERIORITY||Mean Difference (Net)|-7.79|STANDARD_ERROR_OF_MEAN|1.348|<|0.001|TWO_SIDED|95.0|-10.4|-5.1|||Mixed Models Analysis|||||-5.10|-10.40|<0.001
70988759|NCT04657016|141485760|SUPERIORITY||Mean Difference (Net)|11.4|STANDARD_ERROR_OF_MEAN|1.67|<|0.001|TWO_SIDED|95.0|8.2|14.7|||Mixed Models Analysis|||||14.7|8.2|<0.001
71038549|NCT00128219|141584128|SUPERIORITY_OR_OTHER||Vaccine Efficacy, VE=1-RR=1-exp(ß)|36.0||||0.044|TWO_SIDED|95.0|1.0|58.0||The a priori threshold for statistical significance was set at 0.05.|Regression, Cox|The study was multi-center, and the Cox model was stratified by geographic region of the participating clinical sites.|Vaccine efficacy (VE) was defined as one minus the relative risk (RR), which was estimated by exponentiating the treatment parameter (ß) from the Cox model fit.|Time to first acquisition of vaginal type III GBS was analyzed by fitting a Cox Proportional Hazards model stratified by region to the data. The null hypothesis of no vaccine efficacy was tested by the stratified log-rank test (score test). The point and interval estimates for vaccine efficacy were obtained by transforming those for treatment effect in the model.||58|1|0.044
71038550|NCT00128219|141584153|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.12|TWO_SIDED|95.0|0.917|2.34||The a priori threshold for statistical significance for the analysis of secondary endpoints was set at .05 without adjustment for multiplicity.|Fisher Exact|Fisher's exact test was used to test no difference in proportions always vaginal GBS-III negative by arm to a two-sided alternative of a difference.|The OR was calculated from the 2x2 contingency table, and the 95% CI was obtained by inverting the 2-sided 5% level Fisher's exact, with GBS III-TT arm in the numerator and Td arm in the denominator so \<1 favors the GBS III-TT arm.|A two-sided 5% level Fisher's exact test was used to test the null hypothesis of no difference in proportion of participants who were vaginal type III GBS negative throughout the study between treatment arms. The two-sided 5% Fisher's exact test was inverted to obtain a 95% confidence interval for the odds ratio.||2.34|0.917|0.120
71038551|NCT00128219|141584154|SUPERIORITY_OR_OTHER||Vaccine Efficacy, VE=1-RR=1-exp(ß)|36.0||||0.089||95.0|-7.0|61.0||Significance was set at .05 without adjustment for multiplicity. Exchangeable correlation structure and GEE were used for repeated measures.|Binomial regression, log-linear link|The Wald test of treatment effect was used to test no difference in proportion of GBS III pos. by arm against a 2-sided alternative of a difference.|Estimate of vaccine efficacy and 95% CI were obtained by transforming the estimate of log relative risk for treatment effect and the robust Wald CI in the log-linear binomial regression model fit to the proportion of vaginal type III GBS swabs.|The proportion of vaginal swabs that were GBS III culture positive was estimated from a GEE model fit with binomial family, log-link, and exchangeable correlation. Point and robust interval estimates for vaccine efficacy, were obtained by transforming those for treatment effect in this model, and used to test the hypothesis of no efficacy.||61|-7|0.089
71038552|NCT00128219|141584155|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53||||0.256|TWO_SIDED|95.0|0.18|1.45||The a priori threshold for statistical significance for the analysis of secondary endpoints was set at .05 without adjustment for multiplicity.|Fisher Exact|Fisher's exact test was used to test no difference in proportion persistently colonized by arm against a two-sided alternative of a difference.|The OR was calculated from the 2x2 contingency table, and the 95% CI was obtained by inverting the two-sided 5% level Fisher's exact test. The GBS III-TT arm is in the numerator and Td arm in the denominator, so a value \<1 favors the GBS III-TT arm.|A two-sided 5% level Fisher's exact test was used to test the null hypothesis of no difference in proportion of participants who were vaginal type III GBS negative throughout the study between treatment arms. The two-sided 5% Fisher's exact test was inverted to obtain a 95% confidence interval for the odds ratio.||1.45|0.18|0.256
71098609|NCT06399471|141705536|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.229|||||||ANOVA|||An ANOVA was used to compare the Stair Ascent Speed for the Power Knee, C-Leg 4.0, and the Rheo when used.||||0.229
71098610|NCT06399471|141705537|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.528|||||||ANOVA|||An ANOVA was used to compare the Stair Descent Speed for the Power Knee, C-Leg 4.0, and the Rheo when used.||||0.528
71098611|NCT06399471|141705538|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.144|||||||ANOVA|||An ANOVA was used to compare the Ramp Ascent Speed between the Power Knee and the C-Leg 4.0.||||0.144
71098612|NCT06399471|141705538|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.024|||||||ANOVA|||An ANOVA was used to compare the Ramp Ascent Speed between the Power Knee and the Rheo.||||0.024
70988760|NCT04657016|141485761|SUPERIORITY||Mean Difference (Net)|-11.5|STANDARD_ERROR_OF_MEAN|1.97|<|0.001|TWO_SIDED|95.0|-15.3|-7.53|||Mixed Models Analysis|||||-7.53|-15.30|<0.001
70988761|NCT04657016|141485762|SUPERIORITY||Mean Difference (Net)|-27.8|STANDARD_ERROR_OF_MEAN|2.25|<|0.001|TWO_SIDED|95.0|-32.1|-23.2|||Mixed Models Analysis|||||-23.2|-32.1|<0.001
70988762|NCT04657016|141485763|SUPERIORITY||Mean Difference (Net)|-28.0|STANDARD_ERROR_OF_MEAN|2.26|<|0.001|TWO_SIDED|95.0|-32.3|-23.4|||Mixed Models Analysis|||||-23.4|-32.3|<0.001
70988763|NCT04657016|141485764|SUPERIORITY||Mean Difference (Net)|-21.3|STANDARD_ERROR_OF_MEAN|3.76|<|0.001|TWO_SIDED|95.0|-28.4|-13.6|||Mixed Models Analysis|||||-13.6|-28.4|<0.001
70988764|NCT04657016|141485765|SUPERIORITY||Mean Difference (Net)|-11.2|||<|0.001|TWO_SIDED|95.0|-13.5|-8.8|||Mixed Models Analysis|||||-8.8|-13.5|<0.001
70988765|NCT04657016|141485766|SUPERIORITY||Mean Difference (Net)|-0.47|||<|0.001|TWO_SIDED|95.0|-0.53|-0.42|||Mixed Models Analysis|||||-0.42|-0.53|<0.001
70988766|NCT04657016|141485767|SUPERIORITY||Mean Difference (Net)|-48.1|STANDARD_ERROR_OF_MEAN|3.04|<|0.001|TWO_SIDED|95.0|-53.7|-41.7|||Mixed Models Analysis|||||-41.7|-53.7|<0.001
70988767|NCT04657016|141485768|SUPERIORITY||Mean Difference (Net)|3.8|||<|0.001|TWO_SIDED|95.0|2.8|4.9|||ANCOVA|||||4.9|2.8|<0.001
70988768|NCT04657016|141485769|SUPERIORITY||Mean Difference (Net)|12.8|||<|0.001|TWO_SIDED|95.0|9.7|16.0|||ANCOVA|||||16.0|9.7|<0.001
71038553|NCT02034513|141584167|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the 95% confidence interval for the rate ratio (IDeg/IGlar) was ≤1.10 or equivalently if the p-value for the 1-sided test of H0: RR \>1.10 against HA: RR ≤1.10 was less than 2.5%, where RR is the estimated rate ratio IDeg/IGlar.|Treatment ratio|0.89|||<|0.0001|TWO_SIDED|95.0|0.85|0.94|||Poisson||If non-inferiority was confirmed the superiority of IDeg/IGlar was investigated outside of the test hierarchy. Superiority was considered confirmed if the upper bound of the 2-sided 95% confidence interval was \<1.00.|Statistical analysis was performed on the FAS. Number of subjects analysed=subjects in the FAS, who were exposed in at least one maintenance period. Stepwise hierarchical testing procedure was applied for confirmatory endpoints: Step 1: Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the maintenance period.||0.94|0.85|<0.0001
71038554|NCT02034513|141584168|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the 95% confidence interval for the rate ratio (IDeg/IGlar) was ≤1.10 or equivalently if the p-value for the 1-sided test of H0: RR \>1.10 against HA: RR ≤1.10 was less than 2.5%, where RR is the estimated rate ratio IDeg/IGlar.|Treatment ratio|0.64|||<|0.0001|TWO_SIDED|95.0|0.56|0.73|||Poisson||If non-inferiority was confirmed the superiority of IDeg/IGlar was investigated outside of the test hierarchy. Superiority was considered confirmed if the upper bound of the 2-sided 95% confidence interval was \<1.00.|Statistical analysis was performed on the FAS. Number of subjects analysed=subjects in the FAS, who were exposed in at least one maintenance period. Stepwise hierarchical testing procedure was applied for confirmatory endpoints: Step 2: Number of treatment-emergent severe or BG confirmed symptomatic nocturnal hypoglycaemic episodes during the maintenance period.||0.73|0.56|<0.0001
71038555|NCT02034513|141584169|SUPERIORITY_OR_OTHER|||||||0.0016||||||Superiority was confirmed if the p-value was less than 0.025.|McNemar|||Statistical analysis was performed on the FAS. Number of subjects analysed=subjects in the FAS, who were exposed in both the maintenance periods. Stepwise hierarchical testing procedure was applied for confirmatory endpoints: Step 3: Proportion of subjects with one or more severe hypoglycaemic episodes during the maintenance period.||||0.0016
71038556|NCT02034513|141584171|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.40%. Comparison groups: IDeg versus IGlar. Number of subjects included in analysis is 437 (n=220 for IDeg and n=217 for IGlar).|Treatment contrast|0.03|||||TWO_SIDED|95.0|-0.1|0.15||||||"Change from baseline in HbA1c at week 32 (treatment period 1). Before testing the primary endpoint, the secondary supportive efficacy endpoint Change from baseline in HbA1c after 32 weeks of treatment was tested for non-inferiority as a prerequisite for testing the primary endpoint. Analysis was based on mixed model for repeated measurement (MMRM); treatment, sex, region, pre-trial insulin treatment regimen, visit and dosing time were fixed effects, and age and baseline HbA1c were covariates."||0.15|-0.10|
70988776|NCT03470922|141485804|SUPERIORITY||Cox Proportional Hazard|0.75||||0.0055|TWO_SIDED|95.0|0.62|0.92|||Log Rank|Log-rank test stratified by LAG-3 (≥ 1% vs \< 1%), BRAF (mutation positive vs mutation wild-type), AJCC M-stage (M0/M1any\[0\] vs M1any\[1\])||||0.92|0.62|0.0055
70988777|NCT02361762|141485837|OTHER|||||||0.36|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.36
70988778|NCT02361762|141485838|OTHER|||||||0.79|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.79
70988779|NCT02361762|141485839|OTHER|||||||0.009|||||||ANOVA|Repeated measures ANOVA compared group (Training/Waitlist) by time (Pre/Post) by condition (Congruent/Incongruent)||||||0.009
70988780|NCT02361762|141485840|OTHER|||||||0.79||||||ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)|ANCOVA|Compared scores at post testing with baseline scores covaried.||||||.79
70988781|NCT02361762|141485841|OTHER|||||||0.61|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.61
70988782|NCT02361762|141485842|OTHER|||||||0.68|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)0.||||||0.68
70988783|NCT02361762|141485843|OTHER|||||||0.54|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.54
70988784|NCT02361762|141485844|OTHER|||||||0.08|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.08
70988785|NCT02361762|141485845|OTHER|||||||0.37|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.37
70988786|NCT02361762|141485847|OTHER|||||||0.62|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.62
70988787|NCT02361762|141485848|OTHER|||||||0.1|||||||ANCOVA|Repeated measures ANOVA compared group (Training/Waitlist) by time (Pre/Post) by condition (Go/Nogo)||||||0.10
70988788|NCT02361762|141485849|OTHER|||||||0.02|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.02
70988789|NCT04467164|141485920|SUPERIORITY|||||||0.03|||||||ANCOVA|||The null hypothesis is that there were no differences in change of brain activity in the subgenual anterior cingulate cortex (fMRI BOLD signal) between exhalatory-gated and inhalatory-gated tVNS. An ANCOVA model was used with average beta weights in response to stress task at baseline as a covariate. The test was performed with a significance level of 0.05 (two-sided).||||0.03
70988790|NCT04467164|141485920|SUPERIORITY|||||||0.022|||||||ANCOVA|||The null hypothesis is that there were no differences in change of brain activity in the orbitofrontal cortex (fMRI BOLD signal) between exhalatory-gated and inhalatory-gated tVNS. An ANCOVA model was used with average beta weights in response to stress task at baseline as a covariate. The test was performed with a significance level of 0.05 (two-sided).||||0.022
70988791|NCT04467164|141485920|SUPERIORITY|||||||0.027|||||||ANCOVA|||The null hypothesis is that there were no differences in change of brain activity in the ventromedial prefrontal cortex (fMRI BOLD signal) between exhalatory-gated and inhalatory-gated tVNS. An ANCOVA model was used with average beta weights in response to stress task at baseline as a covariate. The test was performed with a significance level of 0.05 (two-sided).||||0.027
70988792|NCT04467164|141485921|SUPERIORITY|||||||0.03|||||||ANOVA|||Null hypothesis is that there was no difference in the change in BDI scale score between exhalatory-gated tVNS and inhalatory-gated tVNS. A repeated measures ANOVA controlled by baseline values was used to test this difference. A p\<0.05 was designated for statistical significance. A positive difference indicates an increase in depressive symptomatology, whereas a negative difference indicates a reduction in depressive symptoms.||||0.03
70988793|NCT04467164|141485922|SUPERIORITY|||||||0.01|||||||Regression, Linear|||The null hypothesis is that there were no differences in percent HFn changes post-pre stimulation between exhalatory-gated and inhalatory-gated tVNS. A General Linear Model (GLM) analysis adjusted by baseline values was used for evaluating differences in this measure between treatment groups. A p\<0.05 was designated for statistical significance. A positive percent change value indicates an increase in cardiovagal activity, whereas a negative change indicates a reduction in cardiovagal activity.||||0.01
70988794|NCT02369835|141485923|OTHER|||||||0.8872|||||||Chi-squared|||||||.8872
70988795|NCT01441440|141485928|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.5||||0.031|TWO_SIDED|95.0|0.14|2.87||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group|||2.87|0.14|0.031
70988796|NCT01441440|141485928|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.12||||0.106|TWO_SIDED|95.0|-0.24|2.48||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group|||2.48|-0.24|0.106
70988797|NCT01441440|141485929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.88||||0.008|TWO_SIDED|95.0|0.77|5.0||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group|||5.00|0.77|0.008
70988798|NCT01441440|141485929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.64||||0.014|TWO_SIDED|95.0|0.54|4.74||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group|||4.74|0.54|0.014
70988799|NCT01441440|141485930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26||||0.025|TWO_SIDED|95.0|0.03|0.49||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group|||0.49|0.03|0.025
70988800|NCT01441440|141485930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25||||0.032|TWO_SIDED|95.0|0.02|0.48||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group|||0.48|0.02|0.032
70988801|NCT01441440|141485931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.18||||0.004|TWO_SIDED|95.0|0.39|1.97||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group|||1.97|0.39|0.004
70988802|NCT01441440|141485931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.06||||0.008|TWO_SIDED|95.0|0.28|1.85||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group|||1.85|0.28|0.008
70988803|NCT01441440|141485932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.5||||0.004|TWO_SIDED|95.0|0.48|2.53||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group|||2.53|0.48|0.004
70988804|NCT01441440|141485932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.77||||0.137|TWO_SIDED|95.0|-0.25|1.79||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group|||1.79|-0.25|0.137
70988805|NCT01441440|141485933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21||||0.073|TWO_SIDED|95.0|-0.02|0.45||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline score of CGI-S as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group|||0.45|-0.02|0.073
70988806|NCT01441440|141485933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25||||0.034|TWO_SIDED|95.0|0.02|0.48||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline score of CGI-S as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group|||0.48|0.02|0.034
70988807|NCT00366548|141485960|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.8||||||95.0|-5.4|3.7||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.7|-5.4|
70988808|NCT00366548|141485960|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-5.5||||||95.0|-14.2|3.3||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.3|-14.2|
70988809|NCT00366548|141485960|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.4||||||95.0|-3.7|2.8||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.8|-3.7|
70988810|NCT00366548|141485960|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-2.9||||||95.0|-6.9|0.7||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||0.7|-6.9|
70988811|NCT00366548|141485960|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.0||||||95.0|-3.0|3.0||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.0|-3.0|
70988812|NCT00366548|141485960|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-2.5||||||95.0|-6.1|0.6||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||0.6|-6.1|
70988813|NCT00366548|141485960|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-6.3||||||95.0|-12.1|-0.7||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||-0.7|-12.1|
70988814|NCT00366548|141485960|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|3.4||||||95.0|-0.9|7.9||||||For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||7.9|-0.9|
70988815|NCT00366548|141485960|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-1.3||||||95.0|-4.1|1.1||||||For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.1|-4.1|
70988816|NCT00366548|141485960|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|1.7||||||95.0|-3.0|6.4||||||For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||6.4|-3.0|
70988817|NCT00366548|141485960|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.4||||||95.0|-5.8|6.7||||||For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||6.7|-5.8|
70988818|NCT00366548|141485960|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.8||||||95.0|-3.2|1.2||||||For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.2|-3.2|
70988819|NCT00366548|141485960|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-1.3||||||95.0|-3.6|0.3||||||For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||0.3|-3.6|
70988820|NCT00366548|141485961|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.0||||||95.0|-2.1|1.9||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated.||1.9|-2.1|
70988821|NCT00366548|141485961|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.4||||||95.0|-1.7|2.6||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated.||2.6|-1.7|
70988822|NCT00366548|141485961|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.4||||||95.0|-2.4|1.1||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.1|-2.4|
70988823|NCT00366548|141485961|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.0||||||95.0|-2.1|1.9||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.9|-2.1|
70988824|NCT00366548|141485961|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.4||||||95.0|-1.2|2.3||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.3|-1.2|
70988825|NCT00366548|141485961|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.4||||||95.0|-2.0|2.9||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.9|-2.0|
70988826|NCT00366548|141485961|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.9||||||95.0|-3.4|1.1||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.1|-3.4|
70988827|NCT00366548|141485961|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.8||||||95.0|-0.8|3.0||||||For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.0|-0.8|
70988828|NCT00366548|141485961|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.6||||||95.0|-3.7|4.9||||||For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.9|-3.7|
70988829|NCT00366548|141485961|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.4||||||95.0|-2.4|1.1||||||For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.1|-2.4|
71038557|NCT02034513|141584171|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.40%. Comparison groups: IDeg versus IGlar. Number of subjects included in analysis is 410 (n=202 for IDeg and n=208 for IGlar).|Treatment contrast|0.11|||||TWO_SIDED|95.0|0.0|0.23||||||"Change from baseline in HbA1c at week 64 (treatment period 2). The baseline values are week 32 values. Before the primary endpoint was tested, the secondary supportive efficacy endpoint Change from baseline in HbA1c after 32 weeks of treatment was tested for non-inferiority as prerequisite for testing the primary endpoint. Analysis was based on MMRM; treatment, sex, region, pre-trial insulin treatment regimen, visit and dosing time were fixed effects, and age and baseline HbA1c were covariates"||0.23|-0.00|
71038558|NCT04158687|141584204|SUPERIORITY||Least Square (LS) Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.8||0.6003|TWO_SIDED|95.0|-4.5|2.6|||Mixed model repeated measures (MMRM)|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||2.6|-4.5|0.6003
71038559|NCT04158687|141584204|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.8||0.392|TWO_SIDED|95.0|-2.0|5.0|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||5.0|-2.0|0.3920
71038560|NCT04158687|141584204|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.8||0.1444|TWO_SIDED|95.0|-0.9|6.0|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||6.0|-0.9|0.1444
71098613|NCT06399471|141705538|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.949|||||||ANOVA|||An ANOVA was used to compare the Ramp Ascent Speed between the Rheo and the C-Leg 4.0.||||0.949
71098614|NCT06399471|141705539|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary||||||0.051|||||||ANOVA|||An ANOVA was used to compare the Ramp Descent Speed for the Power Knee, C-Leg 4.0, and the Rheo when used.||||0.051
70988830|NCT00366548|141485961|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.4||||||95.0|-2.4|1.2||||||For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.2|-2.4|
70988831|NCT00366548|141485961|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.0||||||95.0|-1.7|1.6||||||For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.6|-1.7|
71038561|NCT04158687|141584205|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8065|TWO_SIDED|95.0|-0.3|0.2|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||0.2|-0.3|0.8065
71038562|NCT04158687|141584205|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.1||0.2121|TWO_SIDED|95.0|-0.1|0.4|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||0.4|-0.1|0.2121
71038563|NCT04158687|141584205|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0264|TWO_SIDED|95.0|0.0|0.5|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||0.5|0.0|0.0264
71098615|NCT06399471|141705540|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary||||||0.367|||||||ANOVA|||An ANOVA was used to compare the Steps per Day for the Power Knee, C-Leg 4.0, and the Rheo when used.||||0.367
71038564|NCT04158687|141584206|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.4||0.6101|TWO_SIDED|95.0|-2.1|3.5|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||3.5|-2.1|0.6101
71038565|NCT04158687|141584206|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.4||0.6237|TWO_SIDED|95.0|-3.4|2.1|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||2.1|-3.4|0.6237
71038566|NCT04158687|141584206|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.4||0.1764|TWO_SIDED|95.0|-4.6|0.8|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||0.8|-4.6|0.1764
71038567|NCT00835666|141584236|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.5||||||90.0|92.6|105.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105|92.6|
71038568|NCT00835666|141584237|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.2||||||90.0|94.7|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102|94.7|
71038569|NCT00835666|141584238|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.4||||||90.0|94.9|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102|94.9|
71038570|NCT02312154|141584253|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The change in each of the biophysical parameters was calculated as the pretreatment value minus the posttreatment value for each visit, and these pre- vs posttreatment changes were used in the statistical analysis to minimize the intraindividual variation between the two cheeks. The Wilcoxon rank-sum test was performed to compare the week-by-week changes in parameters of the right and left cheeks (i.e., treated vs untreated).||||<0.05
71038571|NCT02312154|141584254|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The change in each of the biophysical parameters was calculated as the pretreatment value minus the posttreatment value for each visit, and these pre- vs posttreatment changes were used in the statistical analysis to minimize the intraindividual variation between the two cheeks. The Wilcoxon rank-sum test was performed to compare the week-by-week changes in parameters of the right and left cheeks (i.e., treated vs untreated).||||<0.05
71038572|NCT02312154|141584255|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The change in each of the biophysical parameters was calculated as the pretreatment value minus the posttreatment value for each visit, and these pre- vs posttreatment changes were used in the statistical analysis to minimize the intraindividual variation between the two cheeks. The Wilcoxon rank-sum test was performed to compare the week-by-week changes in parameters of the right and left cheeks (i.e., treated vs untreated).||||<0.05
71038573|NCT02312154|141584256|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The change in each of the biophysical parameters was calculated as the pretreatment value minus the posttreatment value for each visit, and these pre- vs posttreatment changes were used in the statistical analysis to minimize the intraindividual variation between the two cheeks. The Wilcoxon rank-sum test was performed to compare the week-by-week changes in parameters of the right and left cheeks (i.e., treated vs untreated).||||<0.05
71038574|NCT02312154|141584257|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The therapeutic outcome was assessed by patient self-assessment using the Global Aesthetic Improvement Scale, which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and -1, worse. Two independent investigators also individually assessed every patient's improvement, and the values of the two scores were averaged for each patient. The Wilcoxon rank-sum test was performed to compare the pre-by-posttreatment changes in treated side.||||<0.05
71038575|NCT02312154|141584258|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The therapeutic outcome was assessed by patient self-assessment using the Global Aesthetic Improvement Scale, which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and -1, worse. Two independent investigators also individually assessed every patient's improvement, and the values of the two scores were averaged for each patient. The Wilcoxon rank-sum test was performed to compare the pre-by-posttreatment changes in treated side.||||<0.05
71038576|NCT01167829|141584262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|183.0|STANDARD_ERROR_OF_MEAN|44.0||0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.05
71038577|NCT04442503|141584305|SUPERIORITY||Least Square Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.16||0.0007|TWO_SIDED|95.0|-6.3|-1.7|||MMRM|||Change from Baseline at Day 15||-1.7|-6.3|0.0007
71038578|NCT04442503|141584306|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.999||0.0008|TWO_SIDED|95.0|-5.4|-1.4|||MMRM|||Change from Baseline at Day 3||-1.4|-5.4|0.0008
71038579|NCT04442503|141584306|SUPERIORITY||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|1.244||0.0203|TWO_SIDED|95.0|-5.4|-0.5|||MMRM|||Change from Baseline at Day 28||-0.5|-5.4|0.0203
71038580|NCT04442503|141584306|SUPERIORITY||LS Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|1.277||0.0067|TWO_SIDED|95.0|-6.0|-1.0|||MMRM|||Change from Baseline at Day 45||-1.0|-6.0|0.0067
70988832|NCT00366548|141485961|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.0||||||95.0|-1.7|1.6||||||For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.6|-1.7|
70988833|NCT00366548|141485964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.96||||||95.0|0.81|1.13||||||For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated||1.13|0.81|
70988834|NCT00366548|141485964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.9||||||95.0|0.72|1.14||||||For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated||1.14|0.72|
70988835|NCT00366548|141485964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.97||||||95.0|0.85|1.1||||||For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated||1.10|0.85|
70988836|NCT00366548|141485964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.96||||||95.0|0.79|1.15||||||For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated||1.15|0.79|
70988837|NCT00366548|141485964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.98||||||95.0|0.86|1.13||||||For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated||1.13|0.86|
70988838|NCT00366548|141485964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.84||||||95.0|0.72|0.97||||||For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated||0.97|0.72|
70988839|NCT00366548|141485964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.84||||||95.0|0.71|0.98||||||For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated||0.98|0.71|
71038581|NCT04442503|141584307|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.196||0.0052|TWO_SIDED|95.0|-0.9|-0.2|||MMRM|||Change from Baseline at Day 15||-0.2|-0.9|0.0052
71038582|NCT04442503|141584308|SUPERIORITY||Odds Ratio (OR)|2.02||||0.0209|TWO_SIDED|95.0|1.112|3.67||P-value are from a generalized estimating equation (GEE) for binary response model, with factors for treatment, baseline HAMD-17 total score, baseline antidepressant use, assessment time point, and time-point-by treatment interaction.|GEE Model|||Day 15||3.670|1.112|0.0209
71038583|NCT04442503|141584308|SUPERIORITY||Odds Ratio (OR)|1.534||||0.1661|TWO_SIDED|95.0|0.837|2.812||P-value are from a GEE for binary response model, with factors for treatment, baseline HAMD-17 total score, baseline antidepressant use, assessment time point, and time-point-by treatment interaction.|GEE Model|||Day 45||2.812|0.837|0.1661
70988840|NCT00366548|141485964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.94||||||95.0|0.81|1.1||||||For serotype 1 the GMC ratio (13vPnC/7vPnC) was calculated||1.10|0.81|
70988841|NCT00366548|141485964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.93||||||95.0|0.83|1.04||||||For serotype 3 the GMC ratio (13vPnC/7vPnC) was calculated||1.04|0.83|
70988842|NCT00366548|141485964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.97||||||95.0|0.83|1.13||||||For serotype 5 the GMC ratio (13vPnC/7vPnC) was calculated||1.13|0.83|
70988843|NCT00366548|141485964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.96||||||95.0|0.81|1.13||||||For serotype 6A the GMC ratio (13vPnC/7vPnC) was calculated||1.13|0.81|
70988844|NCT00366548|141485964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|1.05||||||95.0|0.93|1.18||||||For serotype 7F the GMC ratio (13vPnC/7vPnC) was calculated||1.18|0.93|
70988845|NCT00366548|141485964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.91||||||95.0|0.8|1.04||||||For serotype 19A the GMC ratio (13vPnC/7vPnC) was calculated||1.04|0.80|
70988846|NCT03463941|141485970|OTHER||||||||||||||||||descriptive|||
70988847|NCT03463941|141485971|OTHER||||||||||||||||||descriptive|||
70988848|NCT03463941|141485973|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
70988849|NCT03463941|141485974|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
70988850|NCT03463941|141485975|OTHER||||||||||||||||||descriptive|||
70988851|NCT03463941|141485976|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
70988852|NCT03650452|141485977|SUPERIORITY||Hodges-Lehmann Estimation|-30.48||||0.0007|TWO_SIDED|95.0|-46.99|-13.19||The p-value is 2-sided and it is for the difference of percent change from baseline between TAK-935 and Placebo were computed using Rank Transformed Analysis of Covariance (ANCOVA) adjusting for baseline seizure frequency and indication.|Ranked ANCOVA||The location shift (TAK-935 - Placebo) and Asymptotic 95% confidence interval between TAK-935 and Placebo (TAK-935 - Placebo) were based on Hodges-Lehmann Estimation from un-adjusted rank statistics.|||-13.19|-46.99|0.0007
71038584|NCT04442503|141584309|SUPERIORITY||Odds Ratio (OR)|1.781||||0.111|TWO_SIDED|95.0|0.876|3.621||P-value are from a GEE for binary response model, with factors for treatment, baseline HAMD-17 total score, baseline antidepressant use, assessment time point, and time-point-by treatment interaction.|GEE Model|||Day 15||3.621|0.876|0.1110
70988853|NCT03650452|141485978|SUPERIORITY||Hodges-Lehmann Estimate|-25.93||||0.0024|TWO_SIDED|95.0|-43.96|-10.69||The p-value is 2-sided and it is for the difference of percent change from baseline between TAK-935 and Placebo were computed using Rank Transformed ANCOVA adjusting for baseline seizure frequency and indication.|Ranked ANCOVA||The location shift (TAK-935 - Placebo) and Asymptotic 95% confidence interval between TAK-935 and Placebo (TAK-935 - Placebo) were based on Hodges-Lehmann Estimation from un-adjusted rank statistics.|||-10.69|-43.96|0.0024
70988854|NCT03650452|141485979|SUPERIORITY||Hodges-Lehmann Estimate|-50.0||||0.0001|TWO_SIDED|95.0|-75.03|-25.09||The p-value is 2-sided and it is for the difference of percent change from baseline between TAK-935 and Placebo were computed using Rank Transformed ANCOVA adjusting for baseline seizure frequency.|Ranked ANCOVA||The location shift (TAK-935 - Placebo) and Asymptotic 95% confidence interval between TAK-935 and Placebo (TAK-935 - Placebo) were based on Hodges-Lehmann Estimation from un-adjusted rank statistics.|||-25.09|-75.03|0.0001
70988855|NCT03650452|141485980|SUPERIORITY||Hodges-Lehmann Estimate|-16.22||||0.147|TWO_SIDED|95.0|-39.5|4.49||The p-value is 2-sided and it is for the difference of percent change from baseline between TAK-935 and Placebo were computed using Rank Transformed ANCOVA adjusting for baseline seizure frequency.|Ranked ANCOVA||The location shift (TAK-935 - Placebo) and Asymptotic 95% confidence interval between TAK-935 and Placebo (TAK-935 - Placebo) were based on Hodges-Lehmann Estimation from un-adjusted rank statistics.|||4.49|-39.50|0.1470
70988856|NCT03650452|141485983|SUPERIORITY||Least Square (LS) Mean|0.1|STANDARD_DEVIATION|0.21||0.6829|TWO_SIDED|95.0|-0.32|0.49||The p-value is 2-sided and it is for the difference (TAK-935 - Placebo) of change from baseline between TAK-935 and Placebo was computed using MMRM.|Mixed-Model Repeated Measure (MMRM)||The MMRM model included treatment and visit as factors along with treatment\*visit interaction and baseline score as a covariate; and visit as repeated measure.|||0.49|-0.32|0.6829
70988857|NCT02273050|141485988|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.885|STANDARD_ERROR_OF_MEAN|0.0994|<|0.001|TWO_SIDED|95.0|-1.08|-0.689|||ANCOVA|||||-0.689|-1.080|<0.001
70988858|NCT02273050|141485988|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.213|STANDARD_ERROR_OF_MEAN|0.1005||0.034|TWO_SIDED|95.0|-0.41|-0.016|||ANCOVA|||||-0.016|-0.410|0.034
70988859|NCT02273050|141485989|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.5|||<|0.001|TWO_SIDED|95.0|29.0|46.0|||Fisher Exact|||||46.0|29.0|<0.001
70988860|NCT02273050|141485989|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.7||||0.011|TWO_SIDED|95.0|2.6|18.9|||Fisher Exact|||||18.9|2.6|0.011
70988861|NCT02273050|141485990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.39|STANDARD_ERROR_OF_MEAN|0.158|<|0.001|TWO_SIDED|95.0|-1.7|-1.08|||ANCOVA|||||-1.08|-1.70|<0.001
70988862|NCT02273050|141485990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.159||0.046|TWO_SIDED|95.0|-0.63|0.0|||ANCOVA|||||0.00|-0.63|0.046
70988863|NCT02273050|141485991|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-416.0|STANDARD_ERROR_OF_MEAN|51.54|<|0.001|TWO_SIDED|95.0|-517.3|-314.6|||ANCOVA|||||-314.6|-517.3|<0.001
70988864|NCT02273050|141485991|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-169.3|STANDARD_ERROR_OF_MEAN|52.05||0.001|TWO_SIDED|95.0|-271.7|-66.9|||ANCOVA|||||-66.9|-271.7|0.001
70988865|NCT02273050|141485992|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.9|||<|0.001|TWO_SIDED|95.0|26.0|43.9|||Fisher Exact|||||43.9|26.0|<0.001
71038585|NCT04442503|141584309|SUPERIORITY||Odds Ratio (OR)|2.083||||0.0226|TWO_SIDED|95.0|1.108|3.915||P-value are from a GEE for binary response model, with factors for treatment, baseline HAMD-17 total score, baseline antidepressant use, assessment time point, and time-point-by treatment interaction.|GEE Model|||Day 45||3.915|1.108|0.0226
71038586|NCT04442503|141584310|SUPERIORITY||Odds Ratio (OR)|2.23||||0.0089|TWO_SIDED|95.0|1.223|4.072|||MMRM|||Day 15||4.072|1.223|0.0089
71038587|NCT04442503|141584311|SUPERIORITY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.98||0.0235|TWO_SIDED|95.0|-4.2|-0.3|||MMRM|||Change from Baseline at Day 15||-0.3|-4.2|0.0235
71038588|NCT04442503|141584312|SUPERIORITY||LS Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|1.706||0.0034|TWO_SIDED|95.0|-8.4|-1.7|||MMRM|||Change from Baseline at Day 15||-1.7|-8.4|0.0034
71038589|NCT04442503|141584313|SUPERIORITY||LS Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|2.4||0.0151|TWO_SIDED|95.0|-10.6|-1.2|||MMRM|||Change from Baseline in Core Subscale at Day 15||-1.2|-10.6|0.0151
71038590|NCT04442503|141584313|SUPERIORITY||LS Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|2.27||0.0123|TWO_SIDED|95.0|-10.2|-1.3|||MMRM|||Change from Baseline in Anxiety Subscale at Day 15||-1.3|-10.2|0.0123
71038591|NCT04442503|141584313|SUPERIORITY||LS Mean Difference|-8.6|STANDARD_ERROR_OF_MEAN|2.96||0.004|TWO_SIDED|95.0|-14.5|-2.8|||MMRM|||Change from Baseline in Bech-6 Subscale at Day 15||-2.8|-14.5|0.0040
71038592|NCT04442503|141584313|SUPERIORITY||LS Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|2.609||0.0041|TWO_SIDED|95.0|-12.7|-2.4|||MMRM|||Change from Baseline in Meier Subscale at Day 15||-2.4|-12.7|0.0041
70922823|NCT03833167|141336692|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.07243|TWO_SIDED|95.0|0.53|1.1||One-sided p-value based on log-rank test stratified by baseline Extracapsular extension (yes versus no) and Cortical bone invasion (yes versus no) with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by baseline Extracapsular extension (yes versus no) and Cortical bone invasion (yes versus no) with small strata collapsed.|||1.10|0.53|0.07243
70988866|NCT02273050|141485992|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.6||||0.02|TWO_SIDED|95.0|2.3|20.9|||Fisher Exact|||||20.9|2.3|0.020
70922824|NCT03833167|141336693|SUPERIORITY||Hazard Ratio (HR)|1.47|||||TWO_SIDED|95.0|0.87|2.48|||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by baseline Extracapsular extension (yes versus no) and Cortical bone invasion (yes versus no) with small strata collapsed.|||2.48|0.87|
70988867|NCT02273050|141485993|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.97|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-3.7|-2.25|||ANCOVA|||||-2.25|-3.70|<0.001
70988868|NCT02273050|141485993|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.14|STANDARD_ERROR_OF_MEAN|0.374||0.002|TWO_SIDED|95.0|-1.88|-0.41|||ANCOVA|||||-0.41|-1.88|0.002
70988869|NCT02273050|141485994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.9|||<|0.001|TWO_SIDED|95.0|-13.3|-4.5|||Fisher Exact|||||-4.5|-13.3|<0.001
71038593|NCT04442503|141584315|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.649||0.6912|TWO_SIDED|95.0|-1.0|1.5|||MMRM|||Change from Baseline at Day 3||1.5|-1.0|0.6912
71038594|NCT04442503|141584315|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.874||0.041|TWO_SIDED|95.0|-3.5|-0.1|||MMRM|||Change from Baseline at Day 8||-0.1|-3.5|0.0410
70988870|NCT02273050|141485994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||>|0.999|TWO_SIDED|95.0|-2.3|2.3|||Fisher Exact|||||2.3|-2.3|>0.999
70988871|NCT02297438|141485995|SUPERIORITY||Hazard Ratio (HR)|0.677||||0.0012|TWO_SIDED|95.0|0.529|0.867||1-sided p-value from the adjusted log-rank test.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Letrozole.|Stratified by disease site (visceral vs. non-visceral) per Randomization.||0.867|0.529|0.0012
71038595|NCT04442503|141584315|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.922||0.0444|TWO_SIDED|95.0|-3.7|0.0|||MMRM|||Change from Baseline at Day 15||0.0|-3.7|0.0444
70988872|NCT02297438|141485996|SUPERIORITY||Hazard Ratio (HR)|0.861||||0.14778|TWO_SIDED|95.0|0.651|1.139||1-sided p-value from the log-rank test.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Letrozole.|Stratified by disease site (visceral versus non-visceral) per Randomization.||1.139|0.651|0.14778
70988873|NCT02297438|141485997|SUPERIORITY||Odds Ratio (OR)|1.301||||0.154|TWO_SIDED|95.0|0.805|2.1||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||2.100|0.805|0.154
70988874|NCT02297438|141485998|SUPERIORITY||Odds Ratio (OR)|1.255||||0.206|TWO_SIDED|95.0|0.762|2.066||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||2.066|0.762|0.206
70988875|NCT02297438|141485999|SUPERIORITY||Odds Ratio (OR)|1.315||||0.135|TWO_SIDED|95.0|0.825|2.095||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||2.095|0.825|0.135
70988876|NCT02297438|141486000|SUPERIORITY||Odds Ratio (OR)|1.392||||0.117|TWO_SIDED|95.0|0.825|2.346||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||2.346|0.825|0.117
70988877|NCT02297438|141486003|SUPERIORITY||Odds Ratio (OR)|0.945||||0.471|TWO_SIDED|95.0|0.533|1.673||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||1.673|0.533|0.471
70988878|NCT02297438|141486004|SUPERIORITY||Odds Ratio (OR)|0.878||||0.383|TWO_SIDED|95.0|0.474|1.621||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||1.621|0.474|0.383
70988879|NCT02297438|141486005|SUPERIORITY||Odds Ratio (OR)|1.227||||0.248|TWO_SIDED|95.0|0.725|2.082||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||2.082|0.725|0.248
70988880|NCT02297438|141486006|SUPERIORITY||Odds Ratio (OR)|1.349||||0.189|TWO_SIDED|95.0|0.731|2.509||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||2.509|0.731|0.189
70988881|NCT02297438|141486007|SUPERIORITY||Hazard Ratio (HR)|0.947||||0.36502|TWO_SIDED|95.0|0.698|1.286||1-sided p-value was from exact test.|Log Rank||Assuming Cox proportional hazards, hazard ratio less than 1 indicates reduction in hazard rate in favor of Palbociclib + Letrozole.|Stratified by disease site (visceral versus non-visceral) per Randomization.||1.286|0.698|0.36502
70988882|NCT02297438|141486014|SUPERIORITY||Mean|0.031||||0.1914|TWO_SIDED|95.0|-0.02|0.08|||Mixed effects model||A positive change indicates improvement from baseline and a negative change indicates deterioration.|The analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||0.08|-0.02|0.1914
70988883|NCT02297438|141486015|SUPERIORITY||Mean|3.358||||0.0078|TWO_SIDED|95.0|0.88|5.83|||Mixed effects model||A positive change indicates improvement from baseline and a negative change indicates deterioration.|The analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||5.83|0.88|0.0078
71038596|NCT04442503|141584315|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.924||0.0811|TWO_SIDED|95.0|-3.4|0.2|||MMRM|||Change from Baseline at Day 21||0.2|-3.4|0.0811
71038597|NCT04442503|141584315|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.987||0.1846|TWO_SIDED|95.0|-3.3|0.6|||MMRM|||Change from Baseline at Day 28||0.6|-3.3|0.1846
71038598|NCT04442503|141584315|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.031||0.0625|TWO_SIDED|95.0|-4.0|0.1|||MMRM|||Change from Baseline at Day 45||0.1|-4.0|0.0625
70988884|NCT02297438|141486016|SUPERIORITY||Mean|0.476||||0.7862|TWO_SIDED|95.0|-2.97|3.92|||Mixed effects model||A positive change indicates improvement from baseline and a negative change indicates deterioration.|The analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||3.92|-2.97|0.7862
70988885|NCT02042404|141486019|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||repeated measures ANOVA|||||||<0.0001
70988886|NCT02042404|141486020|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||repeated measures ANOVA|||||||<0.0001
70988887|NCT02042404|141486021|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||repeated measures ANOVA|||||||<0.0001
70988888|NCT02042404|141486022|SUPERIORITY_OR_OTHER|||||||0.0281|TWO_SIDED||||||repeated measures ANOVA|||||||0.0281
70988889|NCT05761444|141486033|OTHER||Least Squares (LS) mean difference|-21.22|||<|0.0001|TWO_SIDED|95.0|-29.26|-13.19||The analysis of covariance (ANCOVA) model with treatment group (ezetimibe/atorvastatin, atorvastatin) and history of statin administration (yes, no) as fixed effects and baseline LDL-C as a covariate.|ANCOVA|||||-13.19|-29.26|<0.0001
70988890|NCT05761444|141486036|OTHER||LS mean difference|-15.96|||<|0.0001|TWO_SIDED|95.0|-23.56|-8.36||The ANCOVA model with treatment group (ezetimibe/atorvastatin, atorvastatin) and history of statin administration (yes, no) as fixed effects and baseline LDL-C as a covariate.|ANCOVA|||||-8.36|-23.56|<0.0001
70988891|NCT04716933|141486040|OTHER||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.48|0.97||||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate||0.97|0.48|
70988892|NCT04716933|141486041|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.54|1.12||||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate||1.12|0.54|
71038599|NCT01945580|141584334|NON_INFERIORITY|With type I error of 0.05 and type II error of 0.20 (power 80%), 362 subjects (181 subjects per arm) are needed to detect non-inferiority of transvaginal biologic to native tissue repair, using a margin of 12.0%.|Adjusted Difference in Percentages|0.2|||||TWO_SIDED|90.0|-5.6|5.9|||||The propensity adjusted treatment difference of Xenform transvaginal mesh (TVM) minus NTR was estimated and missing data was handled using multiple imputation method.|||5.9|-5.6|
71038600|NCT01945580|141584335|NON_INFERIORITY|With type I error of 0.05 and type II error of 0.10 (power 90%), 308 subjects (154 subjects per arm) are needed to detect non-inferiority with a margin of 11.6%.|Adjusted Difference in Percentages|2.0|||||TWO_SIDED|90.0|-0.8|4.7|||||The propensity score adjusted difference in SAE rate of Xenform transvaginal mesh (TVM) vs. NTR was estimated.|||4.7|-0.8|
71038601|NCT03068780|141584347|SUPERIORITY||Odds Ratio (OR)|1.84||||0.013|TWO_SIDED|95.0|1.02|3.3||P-value adjusted with CHW method using CMH test statistics based on a test stratified by EB subtype and target wound size class estimated separately before and after the interim analysis for sample size re-estimation.Threshold of superiority p\<0.05.|Cui, Hung, Wang (CHW) approach|Primary efficacy endpoint was first assessed with the CMH test, but the final statistical analysis was performed based on the CHW approach.|The CMH test statistic from the data until the interim analysis (IA) and the CMH test statistic of the data after the IA must be calculated separately. The results are then combined using the CHW weighted approach to one test-statistic.|||3.30|1.02|0.013
71038602|NCT03068780|141584348|SUPERIORITY|||||||0.302||||||Threshold of superiority is p\<0.05|Chi-squared|||||||0.302
71038603|NCT00989950|141584394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34|STANDARD_DEVIATION|14.0||0.588|TWO_SIDED|95.0|0.0|233.0|||ANOVA|||||233|0|0.588
71038604|NCT00101439|141584395|SUPERIORITY_OR_OTHER_LEGACY||Geometric Mean Ratio (GMR)|0.89||||0.241|TWO_SIDED|95.0|0.73|1.08||Data were back-transformed from the log scale and adjusted for treatment|ANOVA||GMR=Ezetimibe divided by placebo|||1.08|0.73|0.241
71038605|NCT00101439|141584396|SUPERIORITY_OR_OTHER_LEGACY||Geometric Mean Ratio (GMR)|1.02||||0.812|TWO_SIDED|95.0|0.87|1.2||Data were back-transformed from the log scale and adjusted for treatment|ANOVA||GMR=Ezetimibe divided by placebo|||1.20|0.87|0.812
71038606|NCT00840658|141584410|SUPERIORITY|||||||0.036|TWO_SIDED|95.0||||P-value is for the Ciudad Juarez site and it corresponds to the interaction between group (Intervention vs. Control) and study visit (12-months vs. baseline).|Mixed Models Analysis|||Alternative hypothesis: There is a difference between the intervention and the control group with respect to the change in the odds of higher receptive needle sharing. (i.e., The interaction between study visit (baseline, 4-, 8-, and 12-months) and intervention group will be significant at 0.05 significance level. Over time, the intervention group will experience a significant decline in receptive needle sharing but the control group will not.)|To examine the receptive needle sharing outcome, we used ordinal logistic regression for correlated data via GEE with the correlation matrix estimated empirically from the data. The final analyses were stratified by site. The final ordinal logistic regression models included the following main effects: Group, Visit, and Visit\*Group interaction, with our primary interest in the Visit\*Group interaction, as a significant p-value would be indicative of an intervention effect.|||0.036
71038607|NCT00840658|141584411|SUPERIORITY|||||||0.013|TWO_SIDED|95.0||||P-value is for the Ciudad Juarez site and it corresponds to the interaction between group (Intervention vs. Control) and study visit (12-months vs. baseline).|Mixed Models Analysis|||Alternative hypothesis: There is a difference between the intervention and the control group with respect to the change in the mean score IRI (i.e., The interaction between study visit (baseline, 4-, 8-, and 12-months) and intervention group will be significant at 0.05 significance level. Over time, the intervention group will experience a significant decline in the IRI but the control group will not.)|We used gamma regression for correlated data via GEE, with the correlation matrix estimated empirically from the data. The final analyses were stratified by site. The final gamma regression models included the following main effects: Group, Visit, and Visit\*Group interaction, with our primary interest in the Visit\*Group interaction, as a significant p-value would be indicative of an intervention effect.|||0.013
71038608|NCT00474058|141584416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.55||||0.0002||95.0|-5.37|-1.73||No p-value adjustment was necessary, since a multiple test procedure in a hierarchical sequentially rejective manner for the primary variable was applied.|ANCOVA|||Analyses of covariance were performed for the efficacy variables with treatment and (pooled) sites as factors, and baseline value as covariate. Least square means (LS means) for treatment effect were calculated and differences between rotigotine and placebo were presented with 95% confidence intervals (CIs) and p- values.||-1.73|-5.37|0.0002
71038609|NCT00474058|141584417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.26|||<|0.0001||95.0|-6.08|-2.45||No p-value adjustment was necessary, since a multiple testing in a hierarchical sequentially rejective manner for the primary variable was applied.|ANCOVA|||Analyses of covariance were performed for the efficacy variables with treatment and (pooled) sites as factors, and baseline value as covariate. Least square means (LS means) for treatment effect were calculated and differences between rotigotine and placebo were presented with 95% confidence intervals (CIs) and p- values.||-2.45|-6.08|<0.0001
71038610|NCT00474058|141584418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.0301||95.0|-0.79|-0.04|||ANCOVA|||Analyses of covariance were performed for the efficacy variables with treatment and (pooled) sites as factors, and baseline value as covariate. Least square means (LS means) for treatment effect were calculated and differences between rotigotine and placebo were presented with 95% confidence intervals (CIs) and p- values.||-0.04|-0.79|0.0301
70988893|NCT04716933|141486042|OTHER||Percent Difference|11.3|||||TWO_SIDED|95.0|-2.0|24.2||||||Comparision based on unstratified Miettinen \& Nurminen method||24.2|-2.0|
70988894|NCT01005719|141486047|SUPERIORITY_OR_OTHER|||||||0.0242||95.0||||p-value for 10-15 mins Post-dose on Day 7. No adjustments were made for multiple comparisons. P-values \<= 0.05 were reported as statistically significant.|Wilcoxon (Mann-Whitney)|||||||0.0242
70988895|NCT01005719|141486047|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||p-value for 15-20 mins Post-dose on Day 7. No adjustments were made for multiple comparisons. P-values \<= 0.05 were reported as statistically significant.|Wilcoxon (Mann-Whitney)|||||||0.0270
70988896|NCT01005719|141486047|SUPERIORITY_OR_OTHER|||||||0.0067||95.0||||p-value for 20-25 mins Post-dose on Day 7. No adjustments were made for multiple comparisons. P-values \<= 0.05 were reported as statistically significant.|Wilcoxon (Mann-Whitney)|||||||0.0067
70988897|NCT01005719|141486048|SUPERIORITY_OR_OTHER|||||||0.0465||95.0||||p-value for 10-15 mins Post-dose on Day 1|Wilcoxon (Mann-Whitney)|||||||0.0465
70988898|NCT01005719|141486048|SUPERIORITY_OR_OTHER|||||||0.0012||95.0||||p-value for 15-20 mins Post-dose on Day 1|Wilcoxon (Mann-Whitney)|||||||0.0012
70988899|NCT01005719|141486048|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value for 20-25 mins Post-dose on Day 1|Wilcoxon (Mann-Whitney)|||||||<0.0001
70988900|NCT01005719|141486049|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The statistical analysis is for Day 1 (0-5 mins).|Wilcoxon (Mann-Whitney)|||||||<0.05
70988901|NCT01005719|141486049|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The statistical analysis is for Day 1 (0-5 mins).|Wilcoxon (Mann-Whitney)|||||||<0.05
70988902|NCT01005719|141486049|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The statistical analysis is for Day 7 (0-5 mins).|Wilcoxon (Mann-Whitney)|||||||<0.05
71038611|NCT00474058|141584419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.8842||95.0|-0.29|0.25|||ANCOVA|||Analyses of covariance were performed for the efficacy variables with treatment and (pooled) sites as factors, and baseline value as covariate. Least square means (LS means) for treatment effect were calculated and differences between rotigotine and placebo were presented with 95% confidence intervals (CIs) and p- values.||0.25|-0.29|0.8842
70988903|NCT01005719|141486049|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The statistical analysis is for Day 7 (0-5 mins).|Wilcoxon (Mann-Whitney)|||||||<0.05
70988904|NCT05187013|141486125|SUPERIORITY||Mean Difference (Net)|-7.16|STANDARD_ERROR_OF_MEAN|2.72||0.006|TWO_SIDED|95.0|-12.59|-1.73|||t-test, 1 sided|||Null Hypothesis: No improvement between baseline and final SBP, i.e., Final SBP - Baseline SBP \>= 0 Alternative Hypothesis: Final SBP - Baseline SBP \<0 Power calculation: Based on the data, the mean and SD of the change in SBP are -7.16 and 21.40, respectively. Using a one-sided paired t-test with a significance level of 0.05, we should have a power of 83.16%||-1.73|-12.59|0.006
70988905|NCT05187013|141486125|SUPERIORITY||Mean Difference (Net)|-2.15|STANDARD_ERROR_OF_MEAN|1.32||0.056|TWO_SIDED|95.0|-4.79|0.49|||t-test, 1 sided|||Null Hypothesis: No improvement between baseline and final DBP, i.e., Final DBP - Baseline DBP \>= 0 Alternative Hypothesis: Final DBP - Baseline DBP \<0 Power calculation: Based on the data, the mean and SD of the change in SBP are -2.15 and 10.49, respectively. Using a one-sided paired t-test with a significance level of 0.05, we should have a power of 51.48%||0.49|-4.79|0.056
70988906|NCT05187013|141486125|EQUIVALENCE|The margin was considered to be 0.|Mean Difference (Net)|-0.67|STANDARD_ERROR_OF_MEAN|4.13||0.87|TWO_SIDED|95.0|-8.76|7.42|||ANCOVA|Adjusted for baseline SBP and follow-up time|The parameter was defined as the change in SBP for the general health education arm - the change in SBP for the HTN specific education arm adjusted for follow-up time and baseline SBP|"Null hypothesis: No difference between the change in SBP between the two arms~Power calculation: With our sample size, we expect to have 80% power as long as the effect size is at least 0.72 at a 5% level."||7.42|-8.76|0.87
70988907|NCT05187013|141486125|EQUIVALENCE|The margin was taken to be 0|Mean Difference (Net)|0.98|STANDARD_ERROR_OF_MEAN|2.04||0.63|TWO_SIDED|95.0|-3.02|4.98|||ANCOVA|Adjusted for baseline DBP and follow-up time|The parameter was defined as the change in DBP for the general health education arm - the change in DBP for the HTN specific education arm adjusted for follow-up time and baseline SBP|"Null hypothesis: No difference between the change in DBP between the two arms~Power calculation: With our sample size, we expect to have 80% power as long as the effect size is at least 0.72 at a 5% level."||4.98|-3.02|0.63
70988908|NCT05187013|141486126|EQUIVALENCE|The margin is taken to be 0|Odds Ratio, log|0.89|STANDARD_ERROR_OF_MEAN|0.61||0.14|TWO_SIDED|95.0|-0.26|2.29|||Regression, Logistic|A mixed effect model with study arm as a fixed effect and subject-specific random effect.|For OR: the general education arm was taken as the baseline (denominator)|Null hypothesis: There is no difference in medicine adherence between the two groups||2.29|-0.26|0.14
70988909|NCT05187013|141486127|EQUIVALENCE|The margin was taken to be 0.|Odds Ratio, log|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.32|TWO_SIDED|95.0|-0.58|0.19|||Regression, Logistic|Binomial regression for appointment attended/appointment scheduled.|The baseline (denominator) was taken to be the general education arm.|Null hypothesis: No difference in appointment adherence between the study arms||0.19|-0.58|0.32
70988910|NCT01954121|141486255|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for the adjusted difference in seizure free proportion in the LEV minus the seizure free proportion in the CBZ-IR group was set to absolute -20% points.|adjusted difference in proportions|-22.9|||||TWO_SIDED|95.0|-33.1|-12.6||||||The adjusted absolute difference in treatment group seizure-free proportions (referenced as 'Adjusted difference in proportions' in 'Method of Estimation' below) was derived from the adjusted treatment group proportions of seizure-free subjects. The adjusted proportions were derived from a logistic regression model of seizure freedom using treatment and the categories for the number of seizures in the 3-month period prior to Visit 1 (≤2 seizures and \>2 seizures) as covariates.||-12.6|-33.1|
70988911|NCT01678807|141486296|SUPERIORITY_OR_OTHER||Percent Difference|13.8|||||TWO_SIDED|95.0|-3.4|30.3|||||Estimate based on Miettinen \& Nurminen method stratified by asthma status.|||30.3|-3.4|
70988912|NCT01678807|141486296|SUPERIORITY_OR_OTHER||Percent Difference|10.8|||||TWO_SIDED|95.0|-6.4|27.4|||||Estimate based on Miettinen \& Nurminen method stratified by asthma status.|||27.4|-6.4|
70988913|NCT01678807|141486297|SUPERIORITY_OR_OTHER||Percent Difference|6.2|||||TWO_SIDED|95.0|0.4|14.8|||||Estimate based on Miettinen \& Nurminen method stratified by asthma status.|||14.8|0.4|
70988914|NCT01678807|141486297|SUPERIORITY_OR_OTHER||Percent Difference|6.2|||||TWO_SIDED|95.0|0.4|14.8|||||Estimate based on Miettinen \& Nurminen method stratified by asthma status.|||14.8|0.4|
70988915|NCT04400318|141486301|SUPERIORITY||Odds Ratio (OR)|9.81|||<|0.001|TWO_SIDED|95.0|3.13|30.82|||Cochran-Mantel-Haenszel|||Odds Ratio, 95% confidence interval (CI) of the odds ratio and p-value between the dupilumab and placebo group based on the Cochran-Mantel-Haenszel (CMH) test adjusted by ICS dose level (medium/high) and region (Eastern Europe/ROW).||30.82|3.13|<0.001
70988916|NCT04400318|141486302|SUPERIORITY||Least square mean difference|21.76|STANDARD_ERROR_OF_MEAN|14.022||0.138|TWO_SIDED|95.0|-7.73|51.25|||MMRM|||The mixed model for repeated measures (MMRM) included study intervention, baseline value, region, ICS dose level, visits, study intervention by visit interaction, and baseline by visit interaction terms all as fixed effects. Region, ICS, study intervention and visits were considered as categorical parameters.||51.25|-7.73|0.138
71038612|NCT02426918|141584447|NON_INFERIORITY|Non-inferiority for the low dose was confirmed if the upper bound of the CI was \< 15% and if non-inferiority was confirmed for the high dose.|Risk Difference (RD)|-4.2|||||TWO_SIDED|95.0|-11.42|3.0||||||Treatment difference estimates and 95% CIs are calculated accounting for the randomization strata infection type \[cellulitis, noncellulitis\] according to a Mantel-Haenszel type risk difference estimator.||3.00|-11.42|
71038613|NCT02426918|141584447|NON_INFERIORITY|Non-inferiority for the high dose was confirmed if the upper bound of the CI was \< 15%.|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-8.32|8.38||||||Treatment difference estimates and 95% CIs are calculated accounting for the randomization strata infection type \[cellulitis, noncellulitis\] according to a Mantel-Haenszel type risk difference estimator.||8.38|-8.32|
71038614|NCT03306277|141584512|SUPERIORITY||||||<|0.0001|||||||One-sided Exact Binomial Test|||This comparison is made to an assumed rate of zero 0 (or as low as 0.1%). By definition, children with spinal muscular atrophy Type 1 are never able to sit independently.||||<0.0001
71038615|NCT03306277|141584513|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||This comparison is made against the results from the age and gender-matched control participants selected from existing natural history data sets (PNCR) \[Neurol. 2014; 83(9):810-817\].|Data for the current study were compared to historical control data (Finkel et al,2014 - PubMed 25080519) where event-free survival was 6 out of 23 participants (26.1%) at 14 months of age.|||<0.0001
70988917|NCT04400318|141486303|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure is reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only 2 secondary outcome measures (#4 and #5) were included in this procedure.|Least square mean difference|-4.92|STANDARD_ERROR_OF_MEAN|0.798|<|0.001|TWO_SIDED|95.0|-6.5|-3.34|||MMRM|||MMRM model included study intervention (dupilumab, placebo), baseline value of global lung UCSF mucus scoring, region (Eastern Europe/ROW), ICS dose level (medium/high), visit (up to Week 24), study intervention-by-visit interaction and baseline-by-visit interaction as covariates.||-3.34|-6.50|<0.001
70988918|NCT04400318|141486304|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure is reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only 2 secondary outcome measures (#4 and #5) were included in this procedure.|Least square mean difference|-53.45|STANDARD_ERROR_OF_MEAN|39.562||0.18|TWO_SIDED|95.0|-132.09|25.19|||MMRM|||MMRM model included study intervention (dupilumab, placebo), baseline value of trimmed distal \[s\]iRaw at TLC, region (Eastern Europe/ROW), ICS dose level (medium/high), visit (up to Week 24), study intervention-by-visit interaction, and baseline-by-visit interaction as covariates.||25.19|-132.09|0.180
70988919|NCT01096446|141486314|NON_INFERIORITY_OR_EQUIVALENCE|The Chi Square satistical calculation was used for analysis.||||||0.011|TWO_SIDED|95.0|||||Chi-squared|||Four infants(44%)in the control group developed hypertriglyceridemia (\>200 mg/dl) while 100% of the infants in the experimental group developed hypertriglyceridemia (\>200 mg/dl) during the first week of life.||||0.011
71038616|NCT00829452|141584520|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.03||||||90.0|89.11|103.49|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103.49|89.11|
70988920|NCT03395197|141486372|SUPERIORITY||Hazard Ratio (HR)|0.627|||<|0.0001|TWO_SIDED|95.0|0.506|0.777||1-sided|Log Rank||Hazard ratio was based on Cox proportional hazards model; under proportional hazards, if hazard ratio \< 1, it indicates reduction in hazard rate in favor of Talazoparib+Enzalutamide compared to Placebo+Enzalutamide.|The following statistical hypotheses was tested to address the primary objectives: H01: HRrPFS ≥1 vs H11: HRrPFS \<1, where HRrPFS and HRrPFS+ are the hazard ratios (talazoparib in combination with enzalutamide vs. placebo in combination with enzalutamide) of rPFS based on BICR assessment in the all-comers population for Part 2 Cohort 1.||0.777|0.506|<0.0001
70988921|NCT03395197|141486373|SUPERIORITY||Hazard Ratio (HR)|0.447|||<|0.0001|TWO_SIDED|95.0|0.328|0.61||1-sided|Log Rank||Hazard ratio was based on Cox proportional hazards model; under proportional hazards, hazard ratio \< 1 indicates reduction in hazard rate in favor of Talazoparib+Enzalutamide compared to Placebo+Enzalutamide.|The following statistical hypotheses was tested to address the primary objectives: H02: HRrPFS+ ≥1 vs H12: HRrPFS+ \<1, where HRrPFS and HRrPFS+ are the hazard ratios (talazoparib in combination with enzalutamide vs. placebo in combination with enzalutamide) of rPFS based on BICR assessment in the DDR deficient population for Part 2 Cohort 2.||0.610|0.328|<0.0001
70988922|NCT05137041|141486374|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
70988923|NCT05137041|141486376|SUPERIORITY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.015|TWO_SIDED|95.0|-0.817|-0.137|||ANCOVA|The p-value was adjusted using a False Discovery Rate approach (Benjamini-Hochberg).||||-0.137|-0.817|0.015
70988924|NCT05137041|141486377|SUPERIORITY||Least Square Mean Difference|-15.9|STANDARD_ERROR_OF_MEAN|8.47||0.103|TWO_SIDED|95.0|-32.661|0.828||The p-value was adjusted using a False Discovery Rate approach (Benjamini-Hochberg).|ANCOVA|||||0.828|-32.661|0.103
70988925|NCT05137041|141486378|SUPERIORITY||Least Square Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|0.511|1.581||The p-value was adjusted using a False Discovery Rate approach (Benjamini-Hochberg).|ANCOVA|||||1.581|0.511|<0.001
70988926|NCT05137041|141486379|SUPERIORITY||Least Square Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.82||0.121|TWO_SIDED|95.0|-2.976|0.25||The p-value was adjusted using a False Discovery Rate approach (Benjamini-Hochberg).|ANCOVA|||||0.250|-2.976|0.121
70988927|NCT05137041|141486380|SUPERIORITY|||||||0.564||||||The p-value is adjusted using a False Discovery Rate approach (Benjamini-Hochberg).|Log Rank|||||||0.564
70988928|NCT05137041|141486381|SUPERIORITY|||||||0.289|||||||Log Rank|||||||0.289
71038617|NCT00829452|141584521|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|95.34||||||90.0|90.82|100.09|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.09|90.82|
71038618|NCT00829452|141584522|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.98||||||90.0|92.73|101.42|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101.42|92.73|
70988929|NCT05137041|141486382|SUPERIORITY|||||||0.001|||||||Satterthwaite t-test|||Change from Baseline at Day 1 Evening||||0.001
70988930|NCT05137041|141486382|SUPERIORITY|||||||0.035|||||||Satterthwaite t-test|||Change from Baseline at Day 2 Morning||||0.035
70988931|NCT05137041|141486382|SUPERIORITY|||||||0.004|||||||Satterthwaite t-test|||Change from Baseline at Day 2 Evening||||0.004
70988932|NCT05137041|141486382|SUPERIORITY|||||||0.007|||||||Satterthwaite t-test|||Change from Baseline at Day 3 Morning||||0.007
70988933|NCT05137041|141486382|SUPERIORITY|||||||0.005|||||||Satterthwaite t-test|||Change from Baseline at Day 3 Evening||||0.005
70988934|NCT05137041|141486382|SUPERIORITY|||||||0.001|||||||Satterthwaite t-test|||Change from Baseline at Day 4 Morning||||0.001
70988935|NCT05137041|141486382|SUPERIORITY|||||||0.007|||||||Satterthwaite t-test|||Change from Baseline at Day 4 Evening||||0.007
70988936|NCT05137041|141486382|SUPERIORITY|||||||0.096|||||||Satterthwaite t-test|||Change from Baseline at Day 5 Morning||||0.096
70988937|NCT05137041|141486382|SUPERIORITY|||||||0.015|||||||Satterthwaite t-test|||Change from Baseline at Day 5||||0.015
70988938|NCT05137041|141486383|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 1 Evening||||<0.001
71038619|NCT00829452|141584523|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.78||||||90.0|89.34|109.23|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||109.23|89.34|
71038620|NCT00829452|141584524|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.59||||||90.0|94.62|100.66|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||100.66|94.62|
71038621|NCT01296841|141584527|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|We performed t-test statistics for univariate comparisons for continuous variables.||||||<0.05
71038622|NCT01852799|141584546|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||bALP changes from baseline to cycle 1||||0.002
71038623|NCT01852799|141584546|OTHER||||||<|0.001|||||||t-test, 2 sided|||b-ALP changes from baseline to cycle 4||||<0.001
71038624|NCT01852799|141584546|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||DKK-1 changes from baseline to cycle 1||||0.005
71038625|NCT01852799|141584546|OTHER||||||<|0.001|||||||t-test, 2 sided|||DKK-1 changes from baseline to cycle 4||||<0.001
71038626|NCT00834561|141584553|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|104.14||||||90.0|99.99|108.47|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||108.47|99.99|
71038627|NCT00834561|141584554|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|104.07||||||90.0|101.33|106.89|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.89|101.33|
70988939|NCT05137041|141486383|SUPERIORITY|||||||0.001|||||||Satterthwaite t-test|||VRS: Day 2 Morning||||0.001
70988940|NCT05137041|141486383|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 2 Evening||||<0.001
70988941|NCT05137041|141486383|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 3 Morning||||<0.001
70988942|NCT05137041|141486383|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 3 Evening||||<0.001
70988943|NCT05137041|141486383|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 4 Morning||||<0.001
70988944|NCT05137041|141486383|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 4 Evening||||<0.001
70988945|NCT05137041|141486383|SUPERIORITY|||||||0.024|||||||Satterthwaite t-test|||VRS: Day 5 Morning||||0.024
70988946|NCT05137041|141486383|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 5||||<0.001
70988947|NCT05137041|141486384|SUPERIORITY||Least Square Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|0.415|0.903|||ANCOVA|||||0.903|0.415|<0.001
70988948|NCT01808118|141486406|OTHER||||||<|0.001||||||2-sided Pearson's chi-square test|Chi-squared|||||||<0.001
70988949|NCT01808118|141486425|OTHER||||||<|0.001|||||||Log Rank|||The statistical test was performed at a 2-sided significance level of 0.05. Time to flare analysis showed statistically significant lower risk of flare in the adalimumab group than in the placebo group.||||<0.001
70988950|NCT04102098|141486545|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.012|TWO_SIDED|95.0|0.56|0.93|||Log Rank|||Stratification factors include geographic region (Asia Pacific excluding Japan vs. rest of world) and High risk features/curative procedure (Ablation vs. Resection with 1 high risk feature vs. Resection with 2 or more high risk features).||0.93|0.56|0.0120
70988951|NCT04742907|141486557|SUPERIORITY||Cox Proportional Hazard|0.91||||0.767|TWO_SIDED|90.0|0.74|1.12||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: hazard ratio (HR) = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and confidence intervals (CIs) are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|||1.12|0.74|0.767
71038628|NCT00834561|141584555|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|103.68||||||90.0|101.42|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.00|101.42|
71038629|NCT00672984|141584587|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.43||||||90.0|-4.52|-0.34||||||||-0.34|-4.52|
70988952|NCT04742907|141486557|SUPERIORITY||Cox Proportional Hazard|1.17||||0.107|TWO_SIDED|90.0|0.95|1.44||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|||1.44|0.95|0.107
70988953|NCT04742907|141486558|SUPERIORITY||Cox Proportional Hazard|0.9||||0.78|TWO_SIDED|90.0|0.71|1.13||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to GI-2||1.13|0.71|0.780
70988954|NCT04742907|141486558|SUPERIORITY||Cox Proportional Hazard|1.06||||0.33|TWO_SIDED|90.0|0.84|1.34||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to GI-2||1.34|0.84|0.330
71038630|NCT00672984|141584587|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.87||||||90.0|11.45|16.29||||||||16.29|11.45|
71038631|NCT00672984|141584588|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.08||||||90.0|-11.37|-4.78||||||||-4.78|-11.37|
71098616|NCT00601107|141705579|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||1|TWO_SIDED|95.0|0.17|4.22||The p-value was not adjusted for multiple comparisons or a prior significance threshold.|Regression, Exact Logistic|||Estimate of the log odds, relative to the Placebo, in participants with at least 50 % reduction in PASI score at Week 12 or early termination was analyzed using exact logistic regression model adjusted for site and baseline PASI strata (\<=16, \>16).||4.22|0.17|1.000
70988955|NCT04742907|141486558|SUPERIORITY||Cox Proportional Hazard|0.9||||0.788|TWO_SIDED|90.0|0.73|1.11||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to first toleration of clear liquids||1.11|0.73|0.788
70988956|NCT04742907|141486558|SUPERIORITY||Cox Proportional Hazard|1.22||||0.055|TWO_SIDED|90.0|0.99|1.51||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to first toleration of clear liquids||1.51|0.99|0.055
71038632|NCT00672984|141584588|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.13||||||90.0|9.33|16.93||||||||16.93|9.33|
71038633|NCT00672984|141584589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.98||||||90.0|-1.07|3.03||||||||3.03|-1.07|
71038634|NCT00672984|141584589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.11||||||90.0|8.97|13.24||||||||13.24|8.97|
71038635|NCT00672984|141584590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.64||||||90.0|-0.99|4.27||||||||4.27|-0.99|
71038636|NCT00672984|141584590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.8||||||90.0|7.63|13.97||||||||13.97|7.63|
71038637|NCT00672984|141584591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.76||||||90.0|-8.01|-5.51||||||||-5.51|-8.01|
71038638|NCT00672984|141584591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.73||||||90.0|3.08|6.38||||||||6.38|3.08|
71038639|NCT00672984|141584592|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.85||||||90.0|-21.92|-17.78||||||||-17.78|-21.92|
71038640|NCT00672984|141584592|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.44||||||90.0|1.77|5.11||||||||5.11|1.77|
70988957|NCT04742907|141486558|SUPERIORITY||Cox Proportional Hazard|1.07||||0.306|TWO_SIDED|90.0|0.86|1.32||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to absence of distension and presence of bowel sounds and flatus||1.32|0.86|0.306
70988958|NCT04742907|141486558|SUPERIORITY||Cox Proportional Hazard|1.09||||0.243|TWO_SIDED|90.0|0.88|1.35||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to absence of distension and presence of bowel sounds and flatus||1.35|0.88|0.243
70988959|NCT04742907|141486559|SUPERIORITY||Cox Proportional Hazard|1.0||||0.489|TWO_SIDED|90.0|0.81|1.24||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to ready for discharge||1.24|0.81|0.489
71038641|NCT00672984|141584593|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.32||||||90.0|11.75|18.89||||||||18.89|11.75|
71038642|NCT00672984|141584593|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.93||||||90.0|-2.77|4.63||||||||4.63|-2.77|
71038643|NCT00672984|141584594|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|49.85||||||90.0|44.71|54.98||||||||54.98|44.71|
71038644|NCT00672984|141584594|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.63||||||90.0|-0.41|7.66||||||||7.66|-0.41|
71038645|NCT01151618|141584621|OTHER|"Sensitivity and Specificity of values with respect to the Mead Whittenberger method were computed as follows (FL=flow limited and NFL = Non Flow limited):~Sensitivity = (# of FL breaths detected by FOT / # of FL breaths detected by M\&W) \* 100 Specificity =(# of NFL breaths detected by FOT / # of NFL breaths detected by M\&W) \* 100"|DeltaXrs (cmH2O*s/L)|2.6|||||TWO_SIDED|90.0|0.0|100.0|||||DeltaXrs equals average inspiratory reactance minus average expiratory reactance.|||100|0|
71038646|NCT03867760|141584646|SUPERIORITY|The study was designed to detect a difference in pain intensity of at least 0.85 points corresponding to an effect size of 0.57 based on results from our pilot study. The sample size needed was 50 per group based on power of .80, alpha of .05.||||||0.809||||||An a priori significance level was set at 0.05.|ANCOVA|We controlled for pre-treatment scores in addition to baseline pain medications in the ANCOVA analysis.||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in pain intensity than cancer survivors assigned to the relaxation intervention.||||0.809
71038647|NCT03867760|141584647|SUPERIORITY|||||||0.369||||||An a priori significance level was set at 0.05.|ANCOVA|We controlled for pre-treatment scores in addition to baseline pain medications in the ANCOVA analysis.||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in pain interference than cancer survivors assigned to the relaxation intervention.||||0.369
71038648|NCT03867760|141584648|SUPERIORITY|||||||0.029||||||An a priori significance level was set at 0.05.|ANCOVA|We controlled for pre-treatment scores in the ANCOVA analysis.||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in anxiety than cancer survivors assigned to the relaxation intervention.||||0.029
71038649|NCT03867760|141584649|SUPERIORITY|||||||0.236||||||An a priori significance level was set at 0.05.|ANCOVA|We controlled for pre-treatment scores in the ANCOVA analysis.||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in depression than cancer survivors assigned to the relaxation intervention.||||0.236
71038650|NCT03867760|141584650|SUPERIORITY|||||||0.904||||||An a priori significance level was set at 0.05.|ANCOVA|We controlled for pre-treatment scores in the ANCOVA analysis.||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in fatigue than cancer survivors assigned to the relaxation intervention.||||0.904
71038651|NCT03867760|141584651|SUPERIORITY|||||||0.936||||||An a priori significance level was set at 0.05.|ANCOVA|We controlled for pre-treatment scores in the ANCOVA analysis.||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in sleep disturbance than cancer survivors assigned to the relaxation intervention.||||0.936
71038652|NCT03867760|141584652|SUPERIORITY|||||||0.02||||||An a priori significance level was set at 0.05.|t-test, 2 sided|||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention who experience a clinically meaningful improvement in pain intensity will not have a significantly higher pre-treatment treatment credibility and expectancy score than non-improvers.||||0.02
71038653|NCT02286466|141584660|SUPERIORITY||Mean Difference (Final Values)|1.14|STANDARD_ERROR_OF_MEAN|1.38||0.412|TWO_SIDED|95.0|-1.6|3.87||a priori threshold p\<0.05|ANCOVA|Adjusted for baseline values of criterion outcomes and psychotropic medication use||Analysis comparing the change in anxiety symptoms (HAM-A) from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use.||3.87|-1.60|0.412
71038654|NCT02286466|141584661|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|2.51||0.997|TWO_SIDED|95.0|-4.99|4.96||a priori threshold p\<0.05|ANCOVA|Adjusted for baseline values of criterion outcome and psychotropic medication use||Analysis comparing the change in quality of life (FACT-G) from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use||4.96|-4.99|0.997
71098617|NCT00601107|141705579|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.992||95.0|0.13|4.14||The p-value was not adjusted for multiple comparisons or a prior significance threshold.|Regression, Exact Logistic|||Estimate of the log odds, relative to the Placebo, in participants with at least 50 % reduction in PASI score at Week 12 or early termination was analyzed using exact logistic regression model adjusted for site and baseline PASI strata (\<=16, \>16).||4.14|0.13|0.992
70988960|NCT04742907|141486559|SUPERIORITY||Cox Proportional Hazard|1.15||||0.138|TWO_SIDED|90.0|0.93|1.42||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to ready for discharge||1.42|0.93|0.138
70988961|NCT04742907|141486559|SUPERIORITY||Cox Proportional Hazard|1.01||||0.473|TWO_SIDED|90.0|0.82|1.24||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to discharge order written||1.24|0.82|0.473
70988962|NCT04742907|141486559|SUPERIORITY||Cox Proportional Hazard|1.24||||0.045|TWO_SIDED|90.0|1.01|1.53||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to discharge order written||1.53|1.01|0.045
70988963|NCT04742907|141486560|SUPERIORITY|||||||0.923||||||P-value is from two-sample t-test comparing TU-100 15 g/day treatment group versus placebo.|t-test, 2 sided|||||||0.923
70988964|NCT04742907|141486560|SUPERIORITY|||||||0.039||||||P-value is from two-sample t-test comparing TU-100 7.5 g/day treatment group versus placebo.|t-test, 2 sided|||||||0.039
70988965|NCT04742907|141486562|SUPERIORITY||Odds Ratio (OR)|0.79||||0.434|TWO_SIDED|95.0|0.44|1.42||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 1||1.42|0.44|0.434
70988966|NCT04742907|141486562|SUPERIORITY||Odds Ratio (OR)|0.9||||0.71|TWO_SIDED|95.0|0.51|1.59||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 1||1.59|0.51|0.710
70988967|NCT04742907|141486562|SUPERIORITY||Odds Ratio (OR)|1.23||||0.41|TWO_SIDED|95.0|0.75|2.02||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Chi-squared||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 2||2.02|0.75|0.410
70988968|NCT04742907|141486562|SUPERIORITY||Odds Ratio (OR)|1.7||||0.037|TWO_SIDED|95.0|1.03|2.81||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 2||2.81|1.03|0.037
71038655|NCT02286466|141584662|SUPERIORITY||Mean Difference (Final Values)|0.78|STANDARD_ERROR_OF_MEAN|0.63||0.215|TWO_SIDED|95.0|-0.46|2.02||a priori threshold p\<0.05|ANCOVA|Adjusted for baseline values of criterion outcome and psychotropic medication use||Analysis comparing the change in self-report anxiety symptoms on the HADS-Anxiety Subscale from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use.||2.02|-0.46|0.215
71038656|NCT02286466|141584662|SUPERIORITY||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.55||0.379|TWO_SIDED|95.0|-0.6|1.57||a priori threshold p\<0.05|ANCOVA|Adjusted for baseline values of criterion outcome and psychotropic medication use||Analysis comparing the change in self-report depression symptoms on the HADS-Depression Subscale from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use.||1.57|-0.60|0.379
71038657|NCT02286466|141584663|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.81||0.852|TWO_SIDED|95.0|-1.45|1.75||a priori threshold p\<0.05|ANCOVA|Adjusted for baseline values of criterion outcome and psychotropic medication use||Analysis comparing the change in depression symptoms on the PHQ-9 from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use.||1.75|-1.45|0.852
71038658|NCT02153645|141584664|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|2.9||0.179|TWO_SIDED|95.0|-13.9|2.6|||ANCOVA|||||2.6|-13.9|0.179
71038659|NCT02153645|141584664|SUPERIORITY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|2.95||0.458|TWO_SIDED|95.0|-11.2|5.1|||ANCOVA|||||5.1|-11.2|0.458
71038660|NCT00874276|141584666|SUPERIORITY_OR_OTHER||Kendall's Tau-B|0.6|STANDARD_ERROR_OF_MEAN|0.127||0.023|TWO_SIDED|95.0|0.35|0.85||This is the primary outcome, and there is no adjustment.|Wilcoxon (Mann-Whitney)|||We used a Wilcoxon test (and accompanying Kendal's Tau B) because these outcomes are outlier prone.||0.85|0.35|0.023
70988969|NCT04742907|141486562|SUPERIORITY||Odds Ratio (OR)|0.84||||0.579|TWO_SIDED|95.0|0.46|1.55||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 3||1.55|0.46|0.579
70988970|NCT04742907|141486562|SUPERIORITY||Odds Ratio (OR)|0.63||||0.167|TWO_SIDED|95.0|0.33|1.21||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic|||For Day 3||1.21|0.33|0.167
70988971|NCT04742907|141486562|SUPERIORITY||Odds Ratio (OR)|0.63||||0.4|TWO_SIDED|95.0|0.21|1.86||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 4||1.86|0.21|0.400
70988972|NCT04742907|141486562|SUPERIORITY||Odds Ratio (OR)|0.28||||0.083|TWO_SIDED|95.0|0.07|1.18|||Regression, Logistic||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 4||1.18|0.07|0.083
70988973|NCT04742907|141486563|SUPERIORITY||Odds Ratio (OR)|1.33||||0.621|TWO_SIDED|95.0|0.43|4.14||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||POI-related Morbidity status is analyzed using logistic regression with POI-related morbidity as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|||4.14|0.43|0.621
70988974|NCT04742907|141486563|SUPERIORITY||Odds Ratio (OR)|1.03||||0.962|TWO_SIDED|95.0|0.31|3.46||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||POI-related Morbidity status is analyzed using logistic regression with POI-related morbidity as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|||3.46|0.31|0.962
70988975|NCT04742907|141486565|SUPERIORITY||Odds Ratio (OR)|1.16||||0.604|TWO_SIDED|95.0|0.66|2.05||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 1||2.05|0.66|0.604
70988976|NCT04742907|141486565|SUPERIORITY||Odds Ratio (OR)|1.12||||0.693|TWO_SIDED|95.0|0.63|1.99||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 1||1.99|0.63|0.693
70988977|NCT04742907|141486565|SUPERIORITY||Odds Ratio (OR)|1.8||||0.122|TWO_SIDED|95.0|0.85|3.78||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 2||3.78|0.85|0.122
70988978|NCT04742907|141486565|SUPERIORITY||Odds Ratio (OR)|0.78||||0.518|TWO_SIDED|95.0|0.36|1.67||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 2||1.67|0.36|0.518
71038661|NCT00874276|141584667|SUPERIORITY_OR_OTHER||Kendall's Tau B|-0.23|STANDARD_ERROR_OF_MEAN|0.23||0.42|TWO_SIDED|95.0|-0.23|0.69|||Wilcoxon (Mann-Whitney)|||This is the same analysis as the previous, except we use the day 5 pharmacogenetics on the amount of time needed to clear one-half of dose of the drug. This is for the environmental dose. A positive (negative) Kendall's Tau is associated with the EGT allele being faster (slower) than lacking EGT in terms of metabolization of DCA.||0.69|-0.23|0.42
71038662|NCT03247686|141584708|SUPERIORITY|||||||4.96e-05|||||||t-test, 2 sided|||Module M1.2 Placebo versus RSLV-132 All||||0.0000496
71038663|NCT03247686|141584708|SUPERIORITY|||||||1.03e-05|||||||t-test, 2 sided|||Module M3.4 Placebo versus RSLV-132 All||||0.0000103
71038664|NCT03247686|141584708|SUPERIORITY|||||||0.0004398|||||||t-test, 2 sided|||Module M5.12 Placebo versus RSLV-132 All||||0.0004398
71038665|NCT03247686|141584708|SUPERIORITY|||||||6.8e-06|||||||t-test, 2 sided|||Module 1.2 Placebo versus RSLV-132 Responders||||0.0000068
70988979|NCT04742907|141486565|SUPERIORITY||Odds Ratio (OR)|1.45||||0.528|TWO_SIDED|95.0|0.46|4.53||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 3||4.53|0.46|0.528
70988980|NCT04742907|141486565|SUPERIORITY||Odds Ratio (OR)|1.27||||0.689|TWO_SIDED|95.0|0.4|4.07||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 3||4.07|0.40|0.689
70988981|NCT04742907|141486565|SUPERIORITY||Odds Ratio (OR)|0.68||||0.653|TWO_SIDED|95.0|0.12|3.7||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 4||3.70|0.12|0.653
71038666|NCT03247686|141584708|SUPERIORITY|||||||2e-07|||||||t-test, 2 sided|||Module M3.4 Placebo versus RSLV-132 Responders||||0.0000002
71038667|NCT03247686|141584708|SUPERIORITY|||||||9.26e-05|||||||t-test, 2 sided|||Module 5.12 Placebo versus RSLV-132 Responders||||0.0000926
71038668|NCT03247686|141584708|SUPERIORITY|||||||0.001545|||||||t-test, 2 sided|||Module M1.2 Placebo versus RSLV-132 Non-responders||||0.0015450
71038669|NCT03247686|141584708|SUPERIORITY|||||||0.0004632|||||||t-test, 2 sided|||Module M3.4 Placebo versus RSLV-132 Non-responders||||0.0004632
71038670|NCT03247686|141584708|SUPERIORITY|||||||0.009696|||||||t-test, 2 sided|||Module M5.12||||0.0096960
71038671|NCT03247686|141584709|EQUIVALENCE|Two sample t-test with Satterthwaite approximation|Mean Difference (Final Values)|-2.5||||0.18|TWO_SIDED|95.0|-6.34|1.34|||t-test, 2 sided|||Mean difference in change from baseline (95% CI)||1.34|-6.34|0.180
71038672|NCT01472432|141584719|SUPERIORITY_OR_OTHER||||||<|0.05||||||"* Vildagliptin vs Placebo at 3 months.~* Placebo baseline versus placebo 3 months.~* Vildagliptin baseline versus Vildagliptin 3 months."|t-test, 2 sided|"* Vildagliptin vs Placebo at 3 months.~* Placebo baseline versus placebo 3 months.~* Vildagliptin baseline versus Vildagliptin 3 months."||"* Vildagliptin vs Placebo at 3 months.~* Placebo baseline versus placebo 3 months.~* Vildagliptin baseline versus Vildagliptin 3 months."||||<0.05
70988982|NCT04742907|141486565|SUPERIORITY||Odds Ratio (OR)|1.85||||0.452|TWO_SIDED|95.0|0.37|9.25||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 4||9.25|0.37|0.452
70988983|NCT04742907|141486566|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.359|TWO_SIDED|95.0|-1.8|0.6|||Mixed Models Analysis|||For Day 1, least square (LS) mean difference between placebo and TU-100 15 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Nausea as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||0.6|-1.8|0.359
70988984|NCT04742907|141486566|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.907|TWO_SIDED|95.0|-1.3|1.2|||Mixed Models Analysis|||For Day 1, LS mean difference between placebo and TU-100 7.5 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Nausea as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||1.2|-1.3|0.907
70988985|NCT04742907|141486566|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.856|TWO_SIDED|95.0|-1.3|1.6|||Mixed Models Analysis|||For Day 2, LS mean difference between placebo and TU-100 15 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Nausea as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||1.6|-1.3|0.856
70988986|NCT04742907|141486566|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.18|TWO_SIDED|95.0|-2.7|0.5|||Mixed Models Analysis|||For Day 2, LS mean difference between placebo and TU-100 7.5 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Nausea as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||0.5|-2.7|0.180
70988987|NCT04742907|141486566|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.814|TWO_SIDED|95.0|-1.9|2.4|||Mixed Models Analysis|||For Day 3, LS mean difference between placebo and TU-100 15 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Nausea as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||2.4|-1.9|0.814
70988988|NCT04742907|141486566|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.409|TWO_SIDED|95.0|-3.2|1.3|||Mixed Models Analysis|||For Day 3, LS mean difference between placebo and TU-100 7.5 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Nausea as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||1.3|-3.2|0.409
71038673|NCT01472432|141584720|SUPERIORITY_OR_OTHER||||||<|0.05||||||"* Vildagliptin vs Placebo at 3 months.~* Placebo baseline versus placebo 3 months.~* Vildagliptin baseline versus Vildagliptin 3 months"|t-test, 2 sided|"* Vildagliptin vs Placebo at 3 months.~* Placebo baseline versus placebo 3 months.~* Vildagliptin baseline versus Vildagliptin 3 months"||"* Vildagliptin vs Placebo at 3 months.~* Placebo baseline versus placebo 3 months.~* Vildagliptin baseline versus Vildagliptin 3 months."||||<0.05
71038674|NCT01472432|141584721|SUPERIORITY_OR_OTHER||||||<|0.05||||||P-values from multiple comparisons: placebo at baseline vs. placebo at 3 months; placebo at 3 months vs. Vildagliptin at 3 months; Vildagliptin at baseline vs. Vildagliptin at 3 months. P\< 0.05 versus control patients. P \< 0.05 versus baseline.|t-test, 2 sided|||p-values from multiple comparisons: placebo at baseline vs. placebo at 3 months; placebo at 3 months vs. Vildagliptin at 3 months; Vildagliptin at baseline vs. Vildagliptin at 3 months.||||<0.05
71038675|NCT01472432|141584722|SUPERIORITY_OR_OTHER||||||<|0.05||||||P\< 0.05 versus control patients. P \< 0.05 versus baseline|t-test, 2 sided|||||||<0.05
71038676|NCT01390415|141584726|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0374||95.0|||||t-test, 2 sided|||Between-group comparison of Change from Baseline at Month 6||||0.0374
71038677|NCT01390415|141584727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0566||95.0|||||t-test, 2 sided|||Between-group comparison of Change from Baseline at Month 6||||0.0566
70988989|NCT04742907|141486567|SUPERIORITY||Odds Ratio (OR)|0.8||||0.43|TWO_SIDED|95.0|0.46|1.4||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 1||1.40|0.46|0.430
70988990|NCT04742907|141486567|SUPERIORITY||Odds Ratio (OR)|1.1||||0.739|TWO_SIDED|95.0|0.62|1.96||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 1||1.96|0.62|0.739
70988991|NCT04742907|141486567|SUPERIORITY||Odds Ratio (OR)|0.54||||0.13|TWO_SIDED|95.0|0.25|1.2||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 2||1.20|0.25|0.130
70988992|NCT04742907|141486567|SUPERIORITY||Odds Ratio (OR)|0.52||||0.099|TWO_SIDED|95.0|0.24|1.13||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 2||1.13|0.24|0.099
70988993|NCT04742907|141486567|SUPERIORITY||Odds Ratio (OR)|0.78||||0.686|TWO_SIDED|95.0|0.23|2.63||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 3||2.63|0.23|0.686
70988994|NCT04742907|141486567|SUPERIORITY||Odds Ratio (OR)|0.75||||0.644|TWO_SIDED|95.0|0.22|2.56||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 3||2.56|0.22|0.644
70988995|NCT04742907|141486567|SUPERIORITY||Odds Ratio (OR)|0.54||||0.498|TWO_SIDED|95.0|0.09|3.18||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 4||3.18|0.09|0.498
70988996|NCT04742907|141486567|SUPERIORITY||Odds Ratio (OR)|0.71||||0.7|TWO_SIDED|95.0|0.12|4.05||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 4||4.05|0.12|0.700
71038678|NCT02583048|141584728|SUPERIORITY||Mean Difference (Net)|8.4|||||TWO_SIDED|95.1|2.0|14.8|||||Arm 3 minus Arm 1 difference in change from baseline estimated from ANOVA model. Interim analysis conducted when week 24 QT data was available for ≥12 participants stipulated 99.9% confidence interval; original coverage of 95% was widened to 95.1%.|||14.8|2.0|
71038679|NCT02583048|141584728|SUPERIORITY||Mean Difference (Net)|12.1|||||TWO_SIDED|95.1|5.7|18.6|||||Arm 3 minus Arm 2 difference in change from baseline estimated from ANOVA model. Interim analysis conducted when week 24 QT data was available for ≥12 participants stipulated 99.9% confidence interval; original coverage of 95% was widened to 95.1%.|||18.6|5.7|
71038680|NCT02583048|141584735|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.117|||||TWO_SIDED|90.0|0.884|1.411|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 2.||1.411|0.884|
70988997|NCT04742907|141486568|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.919|TWO_SIDED|95.0|-0.9|0.8|||Mixed Models Analysis|||For Day 1, LS mean difference between placebo and TU-100 15 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Abdominal Bloating as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||0.8|-0.9|0.919
71038681|NCT02583048|141584735|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.202|||||TWO_SIDED|90.0|0.989|1.461|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 8.||1.461|0.989|
71038682|NCT02583048|141584735|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.958|||||TWO_SIDED|90.0|0.774|1.187|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 24.||1.187|0.774|
71038683|NCT02583048|141584736|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.986|||||TWO_SIDED|90.0|0.801|1.215|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 2.||1.215|0.801|
71038684|NCT02583048|141584736|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.978|||||TWO_SIDED|90.0|0.764|1.251|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 8.||1.251|0.764|
71038685|NCT02583048|141584736|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.859|||||TWO_SIDED|90.0|0.667|1.108|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 24.||1.108|0.667|
71038686|NCT02583048|141584737|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.036|||||TWO_SIDED|90.0|0.847|1.267|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 2.||1.267|0.847|
70988998|NCT04742907|141486568|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.016|TWO_SIDED|95.0|-1.8|-0.2|||Mixed Models Analysis|||For Day 1, LS mean difference between placebo and TU-100 7.5 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Abdominal Bloating as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||-0.2|-1.8|0.016
70988999|NCT04742907|141486568|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.064|TWO_SIDED|95.0|-0.1|2.0|||Mixed Models Analysis|||For Day 2, LS mean difference between placebo and TU-100 15 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Abdominal Bloating as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||2.0|-0.1|0.064
70989000|NCT04742907|141486568|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.683|TWO_SIDED|95.0|-1.3|0.8|||Mixed Models Analysis|||For Day 2, LS mean difference between placebo and TU-100 7.5 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Abdominal Bloating as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||0.8|-1.3|0.683
70989001|NCT04742907|141486568|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.462|TWO_SIDED|95.0|-1.0|2.1|||Mixed Models Analysis|||For Day 3, LS mean difference between placebo and TU-100 15 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Abdominal Bloating as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||2.1|-1.0|0.462
70989002|NCT04742907|141486568|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.343|TWO_SIDED|95.0|-2.3|0.8|||Mixed Models Analysis|||For Day 3, LS mean difference between placebo and TU-100 7.5 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Abdominal Bloating as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||0.8|-2.3|0.343
70989003|NCT00210158|141486585|SUPERIORITY||Mean Difference (Final Values)|9.7||||0.5|TWO_SIDED|95.0|-23.4|42.8|||t-test, 2 sided|||T-test for a difference of means, assuming independant samples and unequal variances||42.8|-23.4|0.5
70989004|NCT03015610|141486612|SUPERIORITY|||||||0.8716|||||||Wilcoxon (Mann-Whitney)|||||||0.8716
70989005|NCT03015610|141486613|SUPERIORITY|||||||0.2471|||||||Wilcoxon (Mann-Whitney)|||||||0.2471
70989006|NCT03015610|141486614|SUPERIORITY|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
70989007|NCT03015610|141486615|SUPERIORITY|||||||0.2765|||||||Wilcoxon (Mann-Whitney)|||||||0.2765
70989008|NCT03015610|141486616|SUPERIORITY||Risk Ratio (RR)|2.32||||0.191|TWO_SIDED|95.0|0.66|8.2|||Negative binomial regression|||||8.20|0.66|0.191
71038687|NCT02583048|141584737|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.037|||||TWO_SIDED|90.0|0.843|1.276|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 8.||1.276|0.843|
70989009|NCT03015610|141486617|SUPERIORITY||Risk Ratio (RR)|0.53||||0.0435|TWO_SIDED|95.0|0.29|0.98|||Negative binomial regression|||||0.98|0.29|0.0435
70989010|NCT03015610|141486618|SUPERIORITY|||||||0.3808|||||||Wilcoxon (Mann-Whitney)|||||||0.3808
70989011|NCT05692154|141486626|SUPERIORITY||Least Square Mean Difference|-4.24|STANDARD_ERROR_OF_MEAN|2.015||0.038|TWO_SIDED|95.0|-8.24|-0.23|||ANCOVA||Least-squares means, standard errors and p-value are taken from an analysis of covariance model, with treatment group as fixed effect and baseline TNSS (H0 at Visit 4) as covariate.|||-0.23|-8.24|0.038
70989012|NCT05692154|141486627|SUPERIORITY||Least Square Mean Difference|-4.75|STANDARD_ERROR_OF_MEAN|2.088||0.025|TWO_SIDED|95.0|-8.9|-0.6|||ANCOVA||Least-squares means, standard errors and p-value are taken from an analysis of covariance, with treatment group as fixed categorical effect and baseline TOSS (H0 at Visit 4) as covariate.|||-0.60|-8.90|0.025
71038688|NCT02583048|141584737|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.915|||||TWO_SIDED|90.0|0.727|1.151|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 24.||1.151|0.727|
70989013|NCT05692154|141486628|SUPERIORITY||Least Square Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|3.247||0.048|TWO_SIDED|95.0|-12.95|-0.05|||ANCOVA||Least-squares means, standard errors and p-value are taken from an analysis of covariance model, with treatment group as fixed effect and baseline TNSS (H0 at Visit 4) as covariate.|||-0.05|-12.95|0.048
70989014|NCT05692154|141486629|SUPERIORITY||Least Square Mean Difference|-7.47|STANDARD_ERROR_OF_MEAN|2.89||0.011|TWO_SIDED|95.0|-13.21|-1.73|||ANCOVA||Least-squares means, standard errors and p-value are taken from an analysis of covariance, with treatment group as fixed categorical effect and baseline TOSS (H0 at Visit 4) as covariate.|||-1.73|-13.21|0.011
70989015|NCT05692154|141486630|SUPERIORITY||Least Square Mean Difference|-18.45|STANDARD_ERROR_OF_MEAN|10.211||0.074|TWO_SIDED|95.0|-38.74|1.83|||ANCOVA||Least-squares means, standard errors and p-value are taken from an analysis of covariance, with treatment group as fixed categorical effect and baseline TNSS (Day 1) as covariate.|||1.83|-38.74|0.074
70989016|NCT05692154|141486631|SUPERIORITY||Least Square Mean Difference|-4.06|STANDARD_ERROR_OF_MEAN|11.672||0.729|TWO_SIDED|95.0|-27.24|19.12|||ANCOVA||Least-squares means, standard errors and p-value are taken from an analysis of covariance, with treatment group as fixed categorical effect and baseline TOSS (H0 at Day 1) as covariate.|||19.12|-27.24|0.729
70989017|NCT01519245|141486654|SUPERIORITY_OR_OTHER|||||||0.0493||95.0|||||t-test, 2 sided|||Intention to Treat principles of data analysis were applied. The two-sided T-test (95% confidence interval) was used for statistical calculation of primary outcomes. The null hypothesis was that no difference in chest tube losses would be found between the topical tranexamic acid and placebo groups in low-risk cardiac patients undergoing CABG.||||0.0493
70989018|NCT01519245|141486656|SUPERIORITY_OR_OTHER|||||||0.1876||95.0|||||t-test, 2 sided|||Intention to Treat principles of data analysis were applied. The two-sided T-test (95% confidence interval) was used for statistical calculation of secondary outcomes. The null hypothesis was that no difference in chest tube losses would be found between the topical tranexamic acid and placebo groups in low-risk cardiac patients undergoing CABG.||||0.1876
71038689|NCT02583048|141584738|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.043|||||TWO_SIDED|90.0|0.864|1.258|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 2.||1.258|0.864|
71038690|NCT02583048|141584738|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.029|||||TWO_SIDED|90.0|0.858|1.235|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 8.||1.235|0.858|
70989019|NCT01519245|141486657|SUPERIORITY_OR_OTHER|||||||0.093||95.0|||||t-test, 2 sided|||Intention to Treat principles of data analysis were applied. The two-sided T-test (95% confidence interval) was used for statistical calculation of secondary outcomes. The null hypothesis was that no difference in chest tube losses would be found between the topical tranexamic acid and placebo groups in low-risk cardiac patients undergoing CABG.||||0.0930
70989020|NCT01193348|141486668|SUPERIORITY_OR_OTHER||Percent of Complete TMA Response|63.6|||||TWO_SIDED|95.0|40.7|82.8||||||||82.8|40.7|
70989021|NCT01193348|141486669|SUPERIORITY_OR_OTHER||Percent of Complete Hematologic Response|81.8|||||TWO_SIDED|95.0|59.7|94.8||||||||94.8|59.7|
70989022|NCT01193348|141486670|SUPERIORITY_OR_OTHER||Percent of Platelet Count Normalization|95.0|||||TWO_SIDED|95.0|77.2|99.9||||||||99.9|77.2|
70989023|NCT01193348|141486671|SUPERIORITY_OR_OTHER||Percent of eGFR Improvement|86.4|||||TWO_SIDED|95.0|65.1|97.1||||||||97.1|65.1|
70989024|NCT01193348|141486672|SUPERIORITY_OR_OTHER||LS mean change from baseline|204.96|||<|0.0001|TWO_SIDED|95.0|164.44|245.49|||ANOVA|||||245.49|164.44|<0.0001
70989025|NCT01193348|141486673|SUPERIORITY_OR_OTHER||Percent of Complete TMA Response|68.2|||||TWO_SIDED|95.0|45.1|86.1||||||||86.1|45.1|
71098618|NCT00601107|141705579|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||1|TWO_SIDED|95.0|0.15|4.59||The p-value was not adjusted for multiple comparisons or a prior significance threshold.|Regression, Exact Logistic|||Estimate of the log odds, relative to the Placebo, in participants with at least 50 % reduction in PASI score at Week 12 or early termination was analyzed using exact logistic regression model adjusted for site and baseline PASI strata (\<=16, \>16).||4.59|0.15|1.000
71098619|NCT00147537|141705617|SUPERIORITY_OR_OTHER||||||=|0.027|TWO_SIDED||||||binomial test|||A one-sided p-value for H0: objective response rate \<=0.28 using exact binomial test at level 0.05.||||=0.027
70989026|NCT01193348|141486674|SUPERIORITY_OR_OTHER||Percent of Complete Hematologic Response|90.9|||||TWO_SIDED|95.0|70.8|98.9||||||||98.9|70.8|
70989027|NCT01193348|141486675|SUPERIORITY_OR_OTHER||Percent of Platelet Count Normalization|95.5|||||TWO_SIDED|95.0|77.2|99.9||||||||99.9|77.2|
70989028|NCT01193348|141486676|SUPERIORITY_OR_OTHER||Percent of eGFR Improvement|86.4|||||TWO_SIDED|95.0|65.1|97.1||||||||97.1|65.1|
70989029|NCT01193348|141486677|SUPERIORITY_OR_OTHER||LS mean change from baseline|165.43|||<|0.0001|TWO_SIDED|95.0|98.43|232.43|||ANOVA|||||232.43|98.43|<0.0001
70989030|NCT03259334|141486690|SUPERIORITY|||||||0.617|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.617
70989031|NCT03259334|141486690|SUPERIORITY|||||||0.018|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.018
70989032|NCT03259334|141486691|SUPERIORITY|||||||0.253|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.253
70989033|NCT03259334|141486691|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.002
70989034|NCT03259334|141486692|SUPERIORITY|||||||0.764|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline||||||0.764
70989035|NCT03259334|141486692|SUPERIORITY|||||||0.08|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.080
70989036|NCT03259334|141486693|SUPERIORITY|||||||0.44|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.440
70989037|NCT03259334|141486693|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline||||||0.002
70989038|NCT03259334|141486694|SUPERIORITY|||||||0.286|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline||||||0.286
70989039|NCT03259334|141486694|SUPERIORITY|||||||0.005|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.005
70989040|NCT03141086|141486714|SUPERIORITY||Mean Difference (Final Values)|1.711||||0.1272|TWO_SIDED|95.0|-1.34|4.762|||ANOVA|||||4.762|-1.340|0.1272
70989041|NCT03141086|141486715|SUPERIORITY||Mean Difference (Final Values)|2.866||||0.0607|TWO_SIDED|95.0|-0.821|6.553|||Mixed Models Analysis|||3.5 hours post dose||6.553|-0.821|0.0607
70989042|NCT03141086|141486715|SUPERIORITY||Mean Difference (Net)|1.975||||0.0919|TWO_SIDED|95.0|-1.024|4.973|||Mixed Models Analysis|||5.5 hours post dose||4.973|-1.024|0.0919
70989043|NCT03141086|141486715|SUPERIORITY||Mean Difference (Net)|1.576||||0.0811|TWO_SIDED|95.0|-0.697|3.848|||Mixed Models Analysis|||7.5 hours post dose||3.848|-0.697|0.0811
70989044|NCT03141086|141486715|SUPERIORITY||Mean Difference (Net)|0.879||||0.2026|TWO_SIDED|95.0|-1.268|3.026|||Mixed Models Analysis|||9.5 hours post dose||3.026|-1.268|0.2026
70989045|NCT01286272|141486757|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.8457|TWO_SIDED|95.0|0.51|1.74|||Log Rank|||||1.74|0.51|0.8457
70989046|NCT06018350|141486787|OTHER|||||||0.002|||||||McNemar|||||||0.002
70989047|NCT03625986|141486789|OTHER||Mean Difference (Final Values)|-186.68||||0.0039|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0039
70989048|NCT03625986|141486790|OTHER||Mean Difference (Final Values)|-0.06||||0.8103|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.8103
71098620|NCT00147537|141705618|SUPERIORITY_OR_OTHER||||||=|0.121|TWO_SIDED||||||binomial test|||A One-sided p-value for H0: objective response rate \<=0.30 using exact binomial test at level 0.05.||||=0.121
70989049|NCT03625986|141486791|OTHER||Mean Difference (Final Values)|-3.14||||0.0105|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0105
70989050|NCT03625986|141486792|OTHER||Mean Difference (Final Values)|2415.93||||0.0182|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0182
71038691|NCT02583048|141584738|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.808|||||TWO_SIDED|90.0|0.657|0.993|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 24.||0.993|0.657|
70989051|NCT03625986|141486793|OTHER||Mean Difference (Final Values)|1.18||||0.8429|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.8429
70989052|NCT03625986|141486794|OTHER||Mean Difference (Final Values)|0.49||||0.4881|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.4881
70989053|NCT03625986|141486795|OTHER||Mean Difference (Final Values)|1.76||||0.0835|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0835
70989054|NCT03625986|141486796|OTHER||Mean Difference (Final Values)|-0.96||||0.043|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.043
70989055|NCT03625986|141486797|OTHER||Odds Ratio (OR)|4.35||||0.0052|TWO_SIDED||||||Fisher Exact|||||||0.0052
70989056|NCT03625986|141486798|OTHER||Mean Difference (Final Values)|-1.95||||0.0797|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0797
70989057|NCT03625986|141486799|OTHER||Mean Difference (Final Values)|-1.44||||0.1084|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.1084
70989058|NCT03625986|141486800|OTHER||Mean Difference (Final Values)|3.81||||0.3469|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.3469
70989059|NCT03625986|141486801|OTHER||Odds Ratio (OR)|3.3632||||0.0272|TWO_SIDED||||||Fisher Exact|||||||0.0272
71038692|NCT02583048|141584739|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.068|||||TWO_SIDED|90.0|0.903|1.263|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 2.||1.263|0.903|
71038693|NCT02583048|141584739|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.973|||||TWO_SIDED|90.0|0.82|1.155|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 8.||1.155|0.820|
71038694|NCT02583048|141584739|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.803|||||TWO_SIDED|90.0|0.656|0.983|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 24.||0.983|0.656|
71038695|NCT02583048|141584740|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.049|||||TWO_SIDED|90.0|0.881|1.248|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 2.||1.248|0.881|
71038696|NCT02583048|141584740|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.979|||||TWO_SIDED|90.0|0.823|1.165|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 8.||1.165|0.823|
71038697|NCT02583048|141584740|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.808|||||TWO_SIDED|90.0|0.638|1.025|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 24.||1.025|0.638|
71038698|NCT02583048|141584741|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.903|||||TWO_SIDED|90.0|0.778|1.049|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 2.||1.049|0.778|
71038699|NCT02583048|141584741|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.114|||||TWO_SIDED|90.0|0.944|1.315|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 8.||1.315|0.944|
71038700|NCT02583048|141584741|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.804|||||TWO_SIDED|90.0|0.639|1.012|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 24.||1.012|0.639|
71038701|NCT02583048|141584742|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.937|||||TWO_SIDED|90.0|0.81|1.084|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 2.||1.084|0.810|
71038702|NCT02583048|141584742|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.107|||||TWO_SIDED|90.0|0.929|1.318|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 8.||1.318|0.929|
71038703|NCT02583048|141584742|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.856|||||TWO_SIDED|90.0|0.703|1.043|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 24.||1.043|0.703|
71038704|NCT02583048|141584743|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.951|||||TWO_SIDED|90.0|0.825|1.096|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 2.||1.096|0.825|
71038705|NCT02583048|141584743|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.136|||||TWO_SIDED|90.0|0.948|1.362|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 8.||1.362|0.948|
71038706|NCT02583048|141584743|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.898|||||TWO_SIDED|90.0|0.727|1.109|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 24.||1.109|0.727|
71038707|NCT02583048|141584744|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.939|||||TWO_SIDED|90.0|0.806|1.094|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 2.||1.094|0.806|
70989060|NCT03625986|141486802|OTHER||Mean Difference (Final Values)|0.6||||0.589|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.589
70989061|NCT03625986|141486803|OTHER||Mean Difference (Final Values)|-0.3||||0.5448|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.5448
70989062|NCT03625986|141486804|OTHER||Mean Difference (Final Values)|15.3||||0.65|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.65
70989063|NCT03625986|141486805|OTHER||Mean Difference (Final Values)|-4.0||||0.1567|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.1567
70989064|NCT01109004|141486831|SUPERIORITY|||||||0.87||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 38 months post-randomization are equal for those receiving Tandem auto transplant and RVD consolidation therapy.||||0.87
70989065|NCT01109004|141486831|SUPERIORITY|||||||0.37||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 38 months post-randomization are equal for those receiving Tandem auto transplant and Lenalidomide maintenance therapy.||||0.37
71038708|NCT02583048|141584744|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.081|||||TWO_SIDED|90.0|0.864|1.352|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 8.||1.352|0.864|
71038709|NCT02583048|141584744|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.865|||||TWO_SIDED|90.0|0.597|1.253|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 24.||1.253|0.597|
71038710|NCT02583048|141584745|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.95|||||TWO_SIDED|90.0|0.825|1.095|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 2.||1.095|0.825|
71038711|NCT02583048|141584745|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.08|||||TWO_SIDED|90.0|0.862|1.354|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 8.||1.354|0.862|
71038712|NCT02583048|141584745|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.865|||||TWO_SIDED|90.0|0.605|1.239|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 24.||1.239|0.605|
71038713|NCT02583048|141584746|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.984|||||TWO_SIDED|90.0|0.851|1.138|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 2.||1.138|0.851|
71038714|NCT02583048|141584746|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.086|||||TWO_SIDED|90.0|0.866|1.361|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 8.||1.361|0.866|
71038715|NCT02583048|141584746|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.927|||||TWO_SIDED|90.0|0.65|1.322|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 24.||1.322|0.650|
71038716|NCT01851876|141584751|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||Fisher Exact|||||||0.025
71038717|NCT02578641|141584776|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.1942|TWO_SIDED|95.0|0.91|1.56||Between-treatment comparisons were assessed using stratified log-rank test stratified by country and disease stage per randomization stratification.|Log Rank|Log-rank test of Hazards Ration equals 1, using Cox proportional hazards regression.|Hazard ratios were estimated using Cox proportional hazards regression.|||1.56|0.91|0.1942
71038718|NCT01710358|141584793|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Regression, Logistic|||||||0.001
71038719|NCT04406194|141584849|EQUIVALENCE|0.80-1.25 margins for equivalence|Mean Ratio|0.9684||||0|TWO_SIDED|90.0|0.94|0.9977|||ANOVA|||||0.9977|0.9400|0.0000
71038720|NCT04406194|141584850|EQUIVALENCE|0.80 - 1.25 equivalence margin is required.|Mean Ratio|1.0555||||0.0155|TWO_SIDED|90.0|0.9292|1.1989|||ANOVA|||||1.1989|0.9292|0.0155
71038721|NCT04406194|141584851|EQUIVALENCE|0.80 - 1.25 equivalence margin is not required.|Mean Ratio|0.9719||||0|TWO_SIDED|90.0|0.944|1.0006|||ANOVA|||||1.0006|0.9440|0.0000
71038722|NCT01456962|141584862|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||t-test, 2 sided|||||||0.6
71038723|NCT01456962|141584862|SUPERIORITY_OR_OTHER||% change in CD4+:CD8+ T cells ratio|-9.5||||0.4|TWO_SIDED|95.0|-27.3|12.0|||Regression, Linear|Adjusted for treatment group and time on antiretroviral therapy|Change based on a 1 log unit increase in genital:plasma drug ratio|Null hypothesis: Higher genital to plasma antiretroviral drug ratios are not associated with higher cervical CD4+:CD8+ T cell ratios.||12|-27.3|0.4
71038724|NCT02704091|141584891|SUPERIORITY|"The following Null-hypothesis was tested:~H0: λA(t) = λB (t) versus H1: λA(t) ≠ λB (t), where λ(t) represents the hazard at time t, A=diosmectite and B=placebo."|||||=|0.2524|||||||Wilcoxon-Gehan test|||The primary analysis tested the equality of time to recovery between the 2 treatment groups, applying the 2-sided Gehan-Wilcoxon test (α=5%).||||=0.2524
71038725|NCT02704091|141584892|SUPERIORITY||||||=|0.3511|||||||Gehan-Wilcoxon test|||Comparison between the 2 treatment groups for time from diarrhoea onset to recovery, analysed using the Gehan-Wilcoxon test.||||=0.3511
71038726|NCT02704091|141584893|SUPERIORITY||||||=|0.7285|||||||Gehan-Wilcoxon test|||Comparison between the 2 treatment groups for time from diarrhoea onset to first formed stool, analysed using the Gehan-Wilcoxon test.||||=0.7285
71038727|NCT02704091|141584894|SUPERIORITY||||||=|0.1807|||||||Gehan-Wilcoxon test|||Comparison between the 2 treatment groups for time from first study treatment intake to last watery stool, analysed using the Gehan-Wilcoxon test.||||=0.1807
70989066|NCT01109004|141486831|SUPERIORITY|||||||0.27||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 38 months post-randomization are equal for those receiving RVD consolidation and Lenalidomide maintenance therapy.||||0.27
70989067|NCT01109004|141486832|SUPERIORITY|||||||0.92||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with disease progression at 38 months post-randomization are equal for those receiving Tandem auto transplant and RVD consolidation therapy.||||0.92
70989068|NCT01109004|141486832|SUPERIORITY|||||||0.21||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with disease progression at 38 months post-randomization are equal for those receiving Tandem auto transplant and Lenalidomide maintenance therapy.||||0.21
70989069|NCT01109004|141486832|SUPERIORITY|||||||0.22||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with disease progression at 38 months post-randomization are equal for those receiving RVD consolidation and Lenalidomide maintenance therapy.||||0.22
70989070|NCT01109004|141486833|SUPERIORITY|||||||0.26||||||Two sided testing was performed at a significance level of 0.05|Log Rank|||The null hypothesis is that the percentages of participants with OS at 38 months post-randomization are equal for those receiving Tandem auto transplant and RVD consolidation therapy.||||0.26
71038728|NCT02704091|141584895|SUPERIORITY||Least Squares (LS) Mean Difference|-0.04||||0.4294|TWO_SIDED|95.0|-0.15|0.07|||ANCOVA|||Comparison between the 2 treatment groups for number of stools for the overall time period, based on an analysis of covariance (ANCOVA) method for repeated measurements. The model included the number of stools 24 hours before randomisation (baseline) as covariate, treatment, time point (12-hour period), the treatment by time point interaction as fixed effects and participant as random effect.||0.07|-0.15|0.4294
71038729|NCT02704091|141584896|SUPERIORITY||LS Mean Difference|-0.12||||0.0465|TWO_SIDED|95.0|-0.24|0.0|||ANCOVA|||Comparison between the 2 treatment groups for number of watery stools for the overall time period, based on an ANCOVA method for repeated measurements. The model included the number of watery stools 24 hours before randomisation (baseline) as covariate, treatment, time point (12-hour period), the treatment by time point interaction as fixed effects and participant as random effect.||-0.00|-0.24|0.0465
71038730|NCT02420353|141584912|OTHER|||||||0.0498|||||||Mixed Models Analysis|||Mixed effect model||||0.0498
71038731|NCT02420353|141584913|OTHER|Mixed effects model||||||0.7024|||||||Mixed Models Analysis|||||||0.7024
71038732|NCT02420353|141584914|OTHER|Mixed effects model||||||0.135|||||||Mixed Models Analysis|||||||0.135
71038733|NCT02420353|141584915|OTHER|Mixed effects model||||||0.6836|||||||Mixed Models Analysis|||||||0.6836
70989071|NCT01109004|141486833|SUPERIORITY|||||||0.53||||||Two sided testing was performed at a significance level of 0.05|Log Rank|||The null hypothesis is that the percentages of participants with OS at 38 months post-randomization are equal for those receiving Tandem auto transplant and Lenalidomide maintenance therapy.||||0.53
70989072|NCT01109004|141486833|SUPERIORITY|||||||0.57||||||Two sided testing was performed at a significance level of 0.05|Log Rank|||The null hypothesis is that the percentages of participants with OS at 38 months post-randomization are equal for those receiving RVD consolidation and Lenalidomide maintenance therapy.||||0.57
71038734|NCT02420353|141584916|OTHER|mixed effects model||||||0.9271|||||||Mixed Models Analysis|||||||0.9271
71038735|NCT02420353|141584917|OTHER|mixed effects model||||||0.1576|||||||Mixed Models Analysis|||||||0.1576
71038736|NCT02420353|141584918|OTHER|mixed effects model||||||0.5586|||||||Mixed Models Analysis|||||||0.5586
71038737|NCT02420353|141584919|OTHER|mixed effects model||||||0.45|||||||Mixed Models Analysis|||||||0.45
71038738|NCT02420353|141584920|OTHER|mixed effects model||||||0.8573|||||||Mixed Models Analysis|||||||0.8573
71038739|NCT02420353|141584921|OTHER|mixed effects model||||||0.0564|||||||Mixed Models Analysis|||||||0.0564
71038740|NCT02420353|141584922|OTHER|mixed effects model||||||0.7883|||||||Mixed Models Analysis|||||||0.7883
70989073|NCT01109004|141486834|SUPERIORITY|||||||0.63||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with TRM at 38 months post-randomization are equal for those receiving Tandem auto transplant and RVD consolidation therapy.||||0.63
70989074|NCT01109004|141486834|SUPERIORITY|||||||0.15||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with TRM at 38 months post-randomization are equal for those receiving Tandem auto transplant and Lenalidomide maintenance therapy.||||0.15
70989075|NCT01109004|141486834|SUPERIORITY|||||||0.33||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with TRM at 38 months post-randomization are equal for those receiving RVD consolidation and Lenalidomide maintenance therapy.||||0.33
70989076|NCT02410902|141486862|OTHER|ANCOVA using MMRM analysis|Mean Difference (Final Values)|-2.56||||0.038|TWO_SIDED|95.0|-4.98|-0.14|||ANCOVA|||||-0.14|-4.98|0.038
71038741|NCT02420353|141584923|OTHER|mixed effects model||||||0.0901|||||||Mixed Models Analysis|||||||0.0901
71038742|NCT02420353|141584924|OTHER|mixed effects model||||||0.6292|||||||Mixed Models Analysis|||||||0.6292
71038743|NCT02420353|141584925|OTHER|mixed effects model||||||0.161|||||||Mixed Models Analysis|||||||0.161
71038744|NCT02420353|141584926|OTHER|mixed effects model||||||0.4437|||||||Mixed Models Analysis|||||||0.4437
71038745|NCT02420353|141584927|OTHER|mixed effects model||||||0.7325|||||||Mixed Models Analysis|||||||0.7325
71038746|NCT02420353|141584928|OTHER|Mixed effects analysis||||||0.6291|||||||Mixed Models Analysis|||||||0.6291
71038747|NCT02420353|141584929|OTHER|Mixed-effects model||||||0.3332|||||||Mixed Models Analysis|||||||0.3332
71038748|NCT02420353|141584930|OTHER|Mixed effects analysis||||||0.79|||||||Mixed Models Analysis|||||||0.79
71038749|NCT02420353|141584931|OTHER|Mixed effects analysis||||||0.4965|||||||Mixed Models Analysis|||||||0.4965
71038750|NCT02420353|141584932|OTHER|mixed effects analysis||||||0.1331|||||||Mixed Models Analysis|||||||0.1331
71038751|NCT02420353|141584933|OTHER|Mixed-model analysis||||||0.5251|||||||Mixed Models Analysis|||||||0.5251
71038752|NCT02420353|141584934|OTHER|Mixed effects analysis||||||0.1064|||||||Mixed Models Analysis|||||||0.1064
71038753|NCT02420353|141584935|OTHER|Mixed effects analysis||||||0.4852|||||||Mixed Models Analysis|||||||0.4852
71038754|NCT02420353|141584936|OTHER|||||||0.7943|||||||Mixed Models Analysis|||||||0.7943
70989077|NCT02410902|141486863|OTHER|ANCOVA using MMRM analysis|Mean Difference (Final Values)|-1.07||||0.325|TWO_SIDED|95.0|-3.21|1.07|||ANCOVA|||||1.07|-3.21|0.325
70989078|NCT03059810|141486872|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|0.7|STANDARD_DEVIATION|2.63|||TWO_SIDED|95.0|-4.6|5.9|||Linear mixed model (LMM)|A 95% Confidence Interval for the least squares mean difference between the follow up and baseline was used to test for non-inferiority.|Mean difference was calculated as Test (at 12-16 days follow up) - Habitual (at baseline)|It was a single arm study and the subjects' overall vision was compared against the baseline with the habitual lens. Sample size was determined using Power procedure in SAS 9.4 using the input from historical data (alpha=0.05).||5.9|-4.6|
71038755|NCT02420353|141584937|OTHER|||||||0.0894|||||||Mixed Models Analysis|||||||0.0894
71038756|NCT02420353|141584938|OTHER|Mixed effects analysis||||||0.0673|||||||Mixed Models Analysis|||||||0.0673
71038757|NCT02420353|141584939|OTHER|Mixed effects analysis||||||0.0185|||||||Mixed Models Analysis|||||||0.0185
71038758|NCT02420353|141584940|OTHER|mixed effects analysis||||||0.6094|||||||Mixed Models Analysis|||||||0.6094
71038759|NCT02420353|141584941|OTHER|mixed effects analysis||||||0.3279|||||||Mixed Models Analysis|||||||0.3279
71038760|NCT02420353|141584942|OTHER|mixed effects analysis||||||0.2802|||||||Mixed Models Analysis|||||||0.2802
71038761|NCT02420353|141584943|OTHER|||||||0.1064|||||||Mixed Models Analysis|||||||0.1064
71038762|NCT02420353|141584944|OTHER|mixed effects model||||||0.0509|||||||Mixed Models Analysis|||||||0.0509
71038763|NCT02420353|141584945|OTHER|mixed effects analysis||||||0.1605|||||||Mixed Models Analysis|||||||0.1605
70989079|NCT00701727|141486873|SUPERIORITY_OR_OTHER|||||||0.019|||||||t-test, 2 sided|||||||0.019
70989080|NCT00701727|141486874|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70989081|NCT00701727|141486875|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
70989082|NCT00701727|141486876|SUPERIORITY_OR_OTHER|||||||0.12|||||||t-test, 2 sided|||||||0.12
71038764|NCT02420353|141584946|OTHER|mixed effects model||||||0.0357|||||||Mixed Models Analysis|||||||0.0357
71038765|NCT02420353|141584947|OTHER|mixed effects model||||||0.0122|||||||Mixed Models Analysis|||||||0.0122
71038766|NCT02420353|141584948|OTHER|mixed effects model||||||0.5853|||||||Mixed Models Analysis|||||||0.5853
71038767|NCT02420353|141584949|OTHER|mixed effects model||||||0.6288|||||||Mixed Models Analysis|||||||0.6288
71038768|NCT02420353|141584950|OTHER|mixed effects model||||||0.5022|||||||Mixed Models Analysis|||||||0.5022
71038769|NCT02420353|141584951|OTHER|mixed effects model||||||0.7507|||||||Mixed Models Analysis|||||||0.7507
70989083|NCT00701727|141486877|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
70989084|NCT00701727|141486878|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71038770|NCT02420353|141584952|OTHER|mixed effects model|||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
71038771|NCT02420353|141584953|OTHER|mixed effects model||||||0.8581|||||||Mixed Models Analysis|||||||0.8581
70989085|NCT00701727|141486879|SUPERIORITY_OR_OTHER|||||||0.95|||||||t-test, 2 sided|||||||0.95
71038772|NCT02420353|141584954|OTHER|mixed effects model||||||0.0208|||||||Mixed Models Analysis|||||||0.0208
71038773|NCT02420353|141584955|OTHER|Mixed effects model||||||0.8581|||||||Mixed Models Analysis|||||||0.8581
71038774|NCT01149057|141584956|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||Analysis was performed using paired sample t-test for change from baseline.||||<0.0001
71038775|NCT01149057|141584957|SUPERIORITY_OR_OTHER|||||||0.3778|TWO_SIDED|||||P value by analysis of covariance (ANCOVA) for the change from baseline, adjusted to number of days between the first and the second DXA test.|ANCOVA|||Comparison of L1-L4 T-scores||||0.3778
71038776|NCT01149057|141584957|SUPERIORITY_OR_OTHER|||||||0.1541|TWO_SIDED|||||P value by ANCOVA for the change from baseline, adjusted to number of days between the first and the second DXA test.|ANCOVA|||Comparison of Total spine T-score||||0.1541
71038777|NCT01149057|141584957|SUPERIORITY_OR_OTHER|||||||0.789|TWO_SIDED|||||P value by ANCOVA for the change from baseline, adjusted to number of days between the first and the second DXA test.|ANCOVA|||Comparison of Total hip - left T-score||||0.7890
71038778|NCT01149057|141584957|SUPERIORITY_OR_OTHER|||||||0.7094|TWO_SIDED|||||P value by ANCOVA for the change from baseline, adjusted to number of days between the first and the second DXA test.|ANCOVA|||Comparison of Femoral neck - left T-scores.||||0.7094
71038779|NCT01149057|141584963|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 24||||<0.0001
71038780|NCT01149057|141584963|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 48||||<0.0001
71038781|NCT01149057|141584963|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 72||||<0.0001
71038782|NCT01149057|141584963|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 96||||<0.0001
71038783|NCT01149057|141584964|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||||||<0.0001
71038784|NCT01149057|141584965|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||||||<0.0001
71038785|NCT01149057|141584966|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||||||<0.0001
71038786|NCT01149057|141584967|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||Analysis was performed using paired sample t-test for change from baseline.||||<0.0001
71038787|NCT01149057|141584968|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||||||<0.0001
70989086|NCT05113953|141486890|SUPERIORITY||Treatment Difference|-0.42||||0.1893|TWO_SIDED|95.0|-1.06|0.21||P-value was analysed by MMRM method with change from baseline in binge eating days per week at scheduled visit as dependent variable and included fixed effect terms for treatment, trial center, visit week, interaction term of treatment by visit week.|MMRM|||||0.21|-1.06|0.1893
70989087|NCT05113953|141486890|SUPERIORITY||Treatment Difference|-0.06||||0.8502|TWO_SIDED|95.0|-0.69|0.57||P-value was analysed by MMRM method with change from baseline in binge eating days per week at scheduled visit as dependent variable and included fixed effect terms for treatment, trial center, visit week, interaction term of treatment by visit week.|MMRM|||||0.57|-0.69|0.8502
70989088|NCT05113953|141486891|SUPERIORITY||Treatment Difference|-0.54||||0.0313|TWO_SIDED|95.0|-1.02|-0.05||P-value was analysed by MMRM method with change from baseline value as dependent variable and included treatment, trial center, visit week, treatment-by-week interaction as fixed effects and baseline-by-week interaction as covariates.|MMRM|||Change from baseline at Week 8||-0.05|-1.02|0.0313
70989089|NCT05113953|141486891|SUPERIORITY||Treatment Difference|0.19||||0.4471|TWO_SIDED|95.0|-0.3|0.67||P-value was analysed by MMRM method with change from baseline value as dependent variable and included treatment, trial center, visit week, treatment-by-week interaction as fixed effects and baseline-by-week interaction as covariates.|MMRM|||Change from baseline at Week 8||0.67|-0.30|0.4471
70989090|NCT02626819|141486957|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Weight change was analyzed using Wilcoxon Rank-Sum test along with multiple imputation to adjust for missing data||||||<0.05
70989091|NCT02626819|141486958|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Weight change was analyzed using Wilcoxon Rank-Sum test along with multiple imputation to adjust for missing data.||||||<0.05
70989092|NCT02626819|141486959|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Weight change was analyzed using Wilcoxon Rank-Sum test along with multiple imputation to adjust for missing data||||||<0.05
70989093|NCT02626819|141486960|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
70989094|NCT02626819|141486961|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
70989095|NCT02626819|141486962|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
70989096|NCT02626819|141486963|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
70989097|NCT02626819|141486964|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
70989098|NCT00502307|141486970|OTHER||Exact binomial distribution|24.6|||||TWO_SIDED|95.0|19.6|30.2||||||||30.2|19.6|
70989099|NCT00502307|141486970|OTHER||Exact binomial distribution|18.0|||||TWO_SIDED|95.0|13.6|23.1||||||||23.1|13.6|
70989100|NCT00502307|141486971|OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
70989101|NCT00502307|141486971|OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
70989102|NCT00502307|141486972|OTHER|||||||0.005|||||||Log Rank|||||||0.005
70989103|NCT00502307|141486972|OTHER|||||||0.129|||||||Log Rank|||||||0.129
70989104|NCT00502307|141486973|OTHER|||||||0.003|||||||Log Rank|||||||0.003
70989105|NCT00502307|141486973|OTHER|||||||0.089|||||||Log Rank|||||||0.089
70989106|NCT00051558|141486977|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||All comparisons were conducted using a 2-sided significance level of 0.05.|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline lumbar spine bone mineral density (BMD) measurement.||||<0.001
70989107|NCT00051558|141486978|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||All comparisons were conducted using a 2-sided significance level of 0.05.|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline lumbar spine bone mineral density (BMD) measurement.||||<0.001
70989108|NCT00051558|141486979|SUPERIORITY_OR_OTHER|||||||0.058||95.0||||P-value for Month 3|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.058
70989109|NCT00051558|141486979|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 6 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
70989110|NCT00051558|141486979|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 12 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
70989111|NCT00051558|141486979|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
70989112|NCT00051558|141486979|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
71038788|NCT01149057|141584969|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||||||<0.0001
71038789|NCT01149057|141584970|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||||||<0.0001
71038790|NCT01149057|141584971|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 24||||<0.0001
71038791|NCT01149057|141584971|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 48||||<0.0001
71038792|NCT01149057|141584971|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 72||||<0.0001
70989113|NCT00051558|141486979|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
70989114|NCT00051558|141486980|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||P-value for 3 Months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.120
70989115|NCT00051558|141486980|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 6 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
70989116|NCT00051558|141486980|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 12 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
70989117|NCT00051558|141486980|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
70989118|NCT00051558|141486981|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value for 36 month endpoint|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline lumbar spine bone mineral density (BMD) measurement.||||<0.001
70989119|NCT00051558|141486981|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
70989120|NCT00051558|141486981|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
70989121|NCT00051558|141486982|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36-month endpoint|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline femoral neck bone mineral density (BMD) measurement.||||<0.001
70989122|NCT00051558|141486982|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
70989123|NCT00051558|141486982|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.002
70989124|NCT00051558|141486982|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for 18 month endpoint|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline femoral neck bone mineral density (BMD) measurement.||||0.011
70989125|NCT00051558|141486982|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.015
70989126|NCT00051558|141486983|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36 month endpoint|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline total hip bone mineral density (BMD) measurement.||||<0.001
70989127|NCT00051558|141486983|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
70989128|NCT00051558|141486983|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
70989129|NCT00051558|141486983|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value for 18 month endpoint|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline total hip bone mineral density (BMD) measurement.||||0.006
70989130|NCT00051558|141486983|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.009
70989131|NCT00051558|141486984|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 12 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
71038793|NCT01149057|141584971|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 96||||<0.0001
70989132|NCT00051558|141486984|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.015
70989133|NCT00051558|141486984|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.002
70989134|NCT00051558|141486984|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
70989135|NCT00051558|141486985|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for 12 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.011
70989136|NCT00051558|141486985|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.009
70989137|NCT00051558|141486985|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
70989138|NCT00051558|141486985|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
70989139|NCT00051558|141486986|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 1|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
70989140|NCT00051558|141486986|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 6|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
70989141|NCT00051558|141486986|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 18|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
70989142|NCT00051558|141486986|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 36|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
70989143|NCT00051558|141486987|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 1|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
70989144|NCT00051558|141486987|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 6|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
70989145|NCT00051558|141486987|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value for Month 18|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||0.004
70989146|NCT00051558|141486987|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Month 36|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||0.013
70989147|NCT00051558|141486988|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 1|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
70989148|NCT00051558|141486988|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 6|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
70989149|NCT00051558|141486988|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 18|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
70989150|NCT00051558|141486988|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 36|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
70989151|NCT00051558|141486989|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 1|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
70989152|NCT00051558|141486989|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 6|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
70989153|NCT00051558|141486989|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 18|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
70989154|NCT00051558|141486989|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 36|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
70989155|NCT00051558|141486990|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 1|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
70989156|NCT00051558|141486990|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value at Month 6|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
70989157|NCT00051558|141486990|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value at Month 18|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
70989158|NCT00051558|141486990|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value at Month 36|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
70989159|NCT00051558|141486991|SUPERIORITY_OR_OTHER|||||||0.212||95.0||||p-value for Any Fracture|Cochran-Mantel-Haenszel|||||||0.212
70989160|NCT00051558|141486991|SUPERIORITY_OR_OTHER|||||||0.843||95.0||||p-value for Nonvertebral Fracture|Cochran-Mantel-Haenszel|||||||0.843
70989161|NCT00051558|141486991|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||p-value for Vertebral Fracture|Cochran-Mantel-Haenszel|||||||0.007
70989162|NCT00051558|141486991|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||p-value for Clinical Vertebral Fracture|Cochran-Mantel-Haenszel|||||||0.037
70989163|NCT00051558|141486991|SUPERIORITY_OR_OTHER|||||||0.256||95.0||||p-value for Nonvertebral Fragility Fracture|Cochran-Mantel-Haenszel|||||||0.256
70989164|NCT01725152|141487037|SUPERIORITY|||||||0.4475|||||||Linear mixed-effect|||Null hypothesis of no treatment difference in CGI-I will be assessed using a linear mixed-effects model for repeated measures, accounting for treatment (ganaxolone versus placebo) and period at a significant level of 0.05. A sample size of 30 participants in each arm/group was planned in the study will have 90% power to detect a modest effect size of 0.6 at level 0.05 in CGI-I. With a possible dropout rate of 15%, the power for testing the effect size becomes 84%.||||0.4475
70989165|NCT01111539|141487045|SUPERIORITY||Treatment Difference|-1.0|||=|0.644|TWO_SIDED|95.0|-5.2|3.3|||ANCOVA|||The statistical analyses was performed by fitting an analysis of covariance (ANCOVA) model to the change from baseline data (Week 8 Visit) for the MADRS Total Score at the Week 14 visit (LOCF). The model included baseline MADRS Total Score as a covariate and treatment as the main effect.||3.3|-5.2|=0.644
70989166|NCT01111539|141487045|SUPERIORITY||Treatment Difference|-3.7|||=|0.08|TWO_SIDED|95.0|-7.8|0.4|||ANCOVA|||The statistical analyses will be performed by fitting an ANCOVA model to the change from baseline data (Week 8 Visit) for the MADRS Total Score at the Week 14 visit (LOCF). The model will include baseline MADRS Total Score as a covariate and treatment as the main effect.||0.4|-7.8|=0.080
70989167|NCT01111539|141487046|SUPERIORITY||Treatment Difference|-0.3|||=|0.366|TWO_SIDED|95.0|-0.8|0.3|||Cochran-Mantel-Haenszel|||||0.3|-0.8|=0.366
70989168|NCT01111539|141487046|SUPERIORITY||Treatment Difference|-0.4|||=|0.138|TWO_SIDED|95.0|-0.9|0.1|||Cochran-Mantel-Haenszel|||||0.1|-0.9|=0.138
70989169|NCT01111539|141487047|SUPERIORITY||Treatment Difference|0.0|||=|0.995|TWO_SIDED|95.0|-1.2|1.2|||ANCOVA|||||1.2|-1.2|=0.995
70989170|NCT01111539|141487047|SUPERIORITY||Treatment Difference|-0.9|||=|0.118|TWO_SIDED|95.0|-2.1|0.2|||ANCOVA|||||0.2|-2.1|=0.118
70989171|NCT03628417|141487048|NON_INFERIORITY|Examined the objective response rate (ORR) that there was 20% difference between the 2 treatment arms at day 180. With a significance level of 0,05 and a power of 80% the study required 28 evaluable metastases.|Odds Ratio (OR)|0.4489629||||0.3|TWO_SIDED|95.0|-13.3|53.3|||Fisher Exact|||After reviewing existing data from electrochemotherapy with intratumoral bleomycin on small cutaneous metastases ≤3cm , we estimated the expected response rate for electrochemotherapy to 85%. We have no clinical results for the treatment of calcium electroporation, but on the basis of preclinical studies, we decided to accept a difference in response of 20%. All statistical analysis were done using IBM SPSS v24.||53.30|-13.30|0.30
70989172|NCT00372190|141487052|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
70989173|NCT00458406|141487105|SUPERIORITY_OR_OTHER_LEGACY|||||||0.512||95.0|||||t-test, 2 sided|||"We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP.~Description of power calculation: The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% confidence interval (CI) for the difference between the 2 means had a range of 1.282 standard deviation (SD)."||||0.512
70989174|NCT00458406|141487106|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||t-test, 2 sided|||"Two-sided t-test. We hypothesized that Bi-Flex would result in improved adherence but similar effi cacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."||||>0.05
70989175|NCT00458406|141487107|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||t-test, 2 sided|||"Two-sided t-test. We hypothesized that Bi-Flex would result in improved adherence but similar effi cacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."||||>0.05
70989176|NCT00458406|141487108|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Chi-squared|||"Chi-Square test. We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."||||>0.05
70989177|NCT00458406|141487109|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Mann-Whitney test. We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP. The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD.||||>0.05
70989178|NCT00458406|141487109|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||t-test, 2 sided|||"Two-sided t-test. We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."||||<0.05
70989179|NCT00458406|141487111|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||"Mann-Whitney test. We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."||||>0.05
70989180|NCT00458406|141487112|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||"Mann-Whitney test. We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."||||>0.05
70989181|NCT03521154|141487116|SUPERIORITY||Hazard Ratio (HR)|0.16|||<|0.001|TWO_SIDED|95.0|0.1|0.24|||Log Rank||A hazard ratio \< 1 favours osimertinib|||0.24|0.10|<0.001
71098621|NCT02006654|141705655|SUPERIORITY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.46||0.2365|TWO_SIDED|95.0|-1.45|0.36||Corrected for multiplicity|Mixed Models Analysis|Adjusted for effects of country, MMSE stratum-by-week, treatment-by-week, base treatment stratum-by-week, and baseline score-by-week interactions|A negative mean difference indicates a treatment effect in favor of idalopirdine|For demonstrating efficacy, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for idalopirdine at significance level 5%.||0.36|-1.45|0.2365
71098622|NCT02006654|141705656|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.4064|TWO_SIDED|95.0|-0.09|0.23||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Adjusted for effects of country, MMSE stratum-by-week, treatment-by-week, base treatment stratum-by-week, and baseline score-by-week interactions|A negative mean difference indicates a treatment effect in favor of idalopirdine|For demonstrating efficacy, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested at significance level 5%.||0.23|-0.09|0.4064
70989182|NCT03521154|141487117|SUPERIORITY||Hazard Ratio (HR)|0.17|||||TWO_SIDED|95.0|0.1|0.29|||Cox proportional hazard model||A hazard ratio \< 1 favours osimertinib|PFS in Ex19Del positive patients||0.29|0.10|
70989183|NCT03521154|141487117|SUPERIORITY||Hazard Ratio (HR)|0.32||||||95.0|0.19|0.56|||Cox proportional hazard model||A hazard ratio \< 1 favours osimertinib|PFS in L858R positive patients||0.56|0.19|
70989184|NCT03521154|141487118|SUPERIORITY||Hazard Ratio (HR)|0.22|||||TWO_SIDED|95.0|0.15|0.34|||Cox proportional hazard model||A hazard ratio \< 1 favours osimertinib|Negative at screening||0.34|0.15|
70989185|NCT03521154|141487119|SUPERIORITY||Hazard Ratio (HR)|0.17|||<|0.001|TWO_SIDED|95.0|0.09|0.32|||Log Rank||A hazard ratio \< 1 favours osimertinib|||0.32|0.09|<0.001
70989186|NCT03521154|141487121|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.53|TWO_SIDED|95.0|0.42|1.56|||Log Rank||A hazard ratio \< 1 favours osimertinib|||1.56|0.42|0.530
70989187|NCT03521154|141487122|SUPERIORITY||Odds Ratio (OR)|2.77|||<|0.001|TWO_SIDED|95.0|1.54|5.08|||Regression, Logistic||An odds ratio \> 1 favours osimertinib|||5.08|1.54|<0.001
70989188|NCT03521154|141487124|SUPERIORITY||Odds Ratio (OR)|2.06||||0.069|TWO_SIDED|95.0|0.94|4.47|||Regression, Logistic||An odds ratio \> 1 favours osimertinib.|||4.47|0.94|0.069
70989189|NCT03521154|141487127|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.001|TWO_SIDED|95.0|0.11|0.38|||Log Rank||A hazard ratio \< 1 favours osimertinib|||0.38|0.11|<0.001
70989190|NCT03521154|141487128|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.001|TWO_SIDED|95.0|0.14|0.32|||Log Rank||A hazard ratio \< 1 favours osimertinib|||0.32|0.14|<0.001
70989191|NCT03521154|141487129|SUPERIORITY||Hazard Ratio (HR)|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.21|||Log Rank||A hazard ratio \< 1 favours osimertinib|||0.21|0.08|<0.001
70989192|NCT03521154|141487130|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.022|TWO_SIDED|95.0|0.28|0.91|||Log Rank||A hazard ratio \< 1 favours osimertinib|||0.91|0.28|0.022
70989193|NCT03521154|141487131|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.088|TWO_SIDED|95.0|0.35|1.08|||Log Rank||A hazard ratio \< 1 favours osimertinib|||1.08|0.35|0.088
70989194|NCT00365716|141487138|SUPERIORITY_OR_OTHER||Vaccine Efficacy|89.5||||||95.0|70.7|97.3|||||"Vaccine Efficacy (% relative risk reduction)~Confidence Interval based on binomial tail probabilities and not from a dispersion parameter."|||97.3|70.7|
70989195|NCT06150573|141487139|SUPERIORITY||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.498||0.9141|TWO_SIDED|95.0|-1.04|0.93|||ANOVA|||||0.93|-1.04|0.9141
70989196|NCT06150573|141487140|SUPERIORITY||Adjusted Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.494||0.4583|TWO_SIDED|95.0|-0.61|1.34|||ANOVA|||||1.34|-0.61|0.4583
70989197|NCT06150573|141487141|SUPERIORITY||Adjusted Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.061||0.0042|TWO_SIDED|95.0|-0.3|-0.06|||ANOVA|||Week 12||-0.06|-0.30|0.0042
70989198|NCT06150573|141487141|SUPERIORITY||Adjusted Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.074|<|0.0001|TWO_SIDED|95.0|-0.46|-0.17|||ANOVA|||Week 24||-0.17|-0.46|<0.0001
70989199|NCT06150573|141487142|SUPERIORITY||Adjusted Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.016||0.2478|TWO_SIDED|95.0|-0.05|0.01|||ANOVA|||Mean Gingival MLSI, Week 12||0.01|-0.05|0.2478
70989200|NCT06150573|141487142|SUPERIORITY||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.02||0.0957|TWO_SIDED|95.0|-0.07|0.01|||ANOVA|||Mean Gingival MLSI, Week 24||0.01|-0.07|0.0957
70989201|NCT06150573|141487142|SUPERIORITY||Adjusted Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.122||0.0063|TWO_SIDED|95.0|-0.58|-0.1|||ANOVA|||Mean Interproximal MLSI, Week 12||-0.10|-0.58|0.0063
70989202|NCT06150573|141487142|SUPERIORITY||Adjusted Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.147|<|0.0001|TWO_SIDED|95.0|-0.89|-0.31|||ANOVA|||Mean Interproximal MLSI, Week 24||-0.31|-0.89|<0.0001
70989203|NCT06150573|141487142|SUPERIORITY||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.1536|TWO_SIDED|95.0|-0.03|0.01|||ANOVA|||Mean Body MLSI, Week 12||0.01|-0.03|0.1536
70989204|NCT06150573|141487142|SUPERIORITY||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.006||0.1166|TWO_SIDED|95.0|-0.02|0.0|||ANOVA|||Mean Body MLSI, Week 24||0.00|-0.02|0.1166
70989205|NCT06150573|141487143|SUPERIORITY||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|-0.21|-0.07|||ANOVA|||Week 12||-0.07|-0.21|<0.0001
70989206|NCT06150573|141487143|SUPERIORITY||Adjusted Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|-0.25|-0.1|||ANOVA|||Week 24||-0.10|-0.25|<0.0001
70989207|NCT06150573|141487144|SUPERIORITY||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.033||0.04|TWO_SIDED|95.0|-0.13|0.0|||ANOVA|||Week 12||-0.00|-0.13|0.0400
70989208|NCT06150573|141487144|SUPERIORITY||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.037||0.001|TWO_SIDED|95.0|-0.2|-0.05|||ANOVA|||Week 24||-0.05|-0.20|0.0010
70989209|NCT00069095|141487145|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit of the 2-sided 97.5% confidence interval (CI) for the hazard ratio (HR) was less than the predefined limit of 1.23 (the non-inferiority margin). A stratified Cox model was used. In order to retain an experiment-wise two-sided type I error of 5%, the non-inferiority analysis for PFS used a two-sided significance level of 2.5%.|Hazard Ratio (HR)|1.05|||||TWO_SIDED|97.5|0.94|1.18||||||Equivalence of treatment arm A ('XELOX') to treatment arm B ('FOLFOX-4') was tested via the following hypotheses - H0: HRA/B \>/= 1.23 versus H1: HRA/B \< 1.23. HRA/B denotes the hazard of disease progression or death under treatment A ('XELOX') divided by the hazard of disease progression or death under treatment B ('FOLFOX-4').||1.18|0.94|
70989210|NCT00069095|141487146|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit of the 2-sided 97.5% confidence interval (CI) for the hazard ratio (HR) was less than the predefined limit of 1.23 (the non-inferiority margin). A stratified Cox model was used. In order to retain an experiment-wise two-sided type I error of 5%, the non-inferiority analysis for PFS used a two-sided significance level of 2.5%.|Hazard Ratio (HR)|1.22|||||TWO_SIDED|97.5|1.05|1.42||||||Equivalence of treatment arm A ('XELOX') to treatment arm B ('FOLFOX-4') was tested via the following hypotheses - H0: HRA/B \>/= 1.23 versus H1: HRA/B \< 1.23. HRA/B denotes the hazard of disease progression or death under treatment A ('XELOX') divided by the hazard of disease progression or death under treatment B ('FOLFOX-4').||1.42|1.05|
70989211|NCT00069095|141487147|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7|||<|0.0001|TWO_SIDED|97.5|0.58|0.83|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||0.83|0.58|<0.0001
70989212|NCT00069095|141487148|NON_INFERIORITY_OR_EQUIVALENCE|Fewer events were expected in the 'on-treatment analysis', thus leading to reduced power. No formal statistical testing was therefore applied.|Hazard Ratio (HR)|1.24|||||TWO_SIDED|97.5|1.07|1.44||||||HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV).||1.44|1.07|
70989213|NCT00069095|141487149|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|97.5|0.52|0.75|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||0.75|0.52|<0.0001
70989214|NCT00069095|141487150|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit of the 2-sided 97.5% confidence interval (CI) for the hazard ratio (HR) was less than the predefined limit of 1.23 (the non-inferiority margin). A stratified Cox model was used. In order to retain an experiment-wise two-sided type I error of 5%, the non-inferiority analysis for PFS used a two-sided significance level of 2.5%.|Hazard Ratio (HR)|1.03|||||TWO_SIDED|97.5|0.92|1.15||||||Equivalence of treatment arm A ('XELOX') to treatment arm B ('FOLFOX-4') was tested via the following hypotheses - H0: HRA/B \>/= 1.23 versus H1: HRA/B \< 1.23. HRA/B denotes the hazard of disease progression or death under treatment A ('XELOX') divided by the hazard of disease progression or death under treatment B ('FOLFOX-4').||1.15|0.92|
70989215|NCT00069095|141487151|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0015|TWO_SIDED|97.5|0.72|0.95|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||0.95|0.72|0.0015
70989216|NCT00069095|141487152|NON_INFERIORITY_OR_EQUIVALENCE|This study was not powered for testing non-inferiority of XELOX vs FOLFOX-4 with respect to overall survival and no margin could be derived following the effect retention concept. The same margins used for the PFS analysis \[Non-inferiority was demonstrated if the upper limit of the 2-sided 97.5% confidence interval (CI) for the hazard ratio (HR) was less than the predefined limit of 1.23 (the non-inferiority margin)\] were therefore applied to OS as well.|Hazard Ratio (HR)|0.97|||||TWO_SIDED|97.5|0.84|1.14||||||HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV).||1.14|0.84|
70989217|NCT00069095|141487153|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.1921|TWO_SIDED|97.5|0.72|1.09|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented together with the 97.5% confidence interval.||1.09|0.72|0.1921
70989218|NCT00069095|141487154|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0023|TWO_SIDED|97.5|0.72|0.95|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||0.95|0.72|0.0023
71098623|NCT02006654|141705657|SUPERIORITY||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|0.63||0.4064|TWO_SIDED|95.0|-0.57|1.92||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Adjusted for effects of country, MMSE stratum-by-week, treatment-by-week, base treatment stratum-by-week, and baseline score-by-week interactions|A positive mean difference indicates a treatment effect in favour of idalopirdine|For demonstrating efficacy, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested at significance level 5%.||1.92|-0.57|0.4064
71098624|NCT01933425|141705670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||<|0.05|TWO_SIDED|95.0|0.07|0.59|||t-test, 2 sided|||||0.59|0.07|<0.05
71098625|NCT01933425|141705671|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|||<|0.05|TWO_SIDED|95.0|0.06|0.54|||t-test, 2 sided|||||0.54|0.06|<0.05
71098626|NCT00676689|141705673|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier|0.971|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.889|0.993||||||||0.993|0.889|
70989219|NCT00069095|141487155|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was based on the two-sided 97.5% confidence interval for OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV). Non-inferiority of XELOX with/without bevacizumab to FOLFOX-4 with/without bevacizumab was concluded if the lower limit of this confidence interval is above 0.66.|Odds Ratio (OR)|0.89|||||TWO_SIDED|97.5|0.72|1.09||||||Non-inferiority of XELOX with/without bevacizumab to FOLFOX-4 with/without bevacizumab was tested by the pair of hypotheses - H0: OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV) \</= 0.66 versus H1: OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV) \> 0.66, where OR denotes Odds ratio.||1.09|0.72|
70989220|NCT00069095|141487156|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.3091|TWO_SIDED|97.5|0.71|1.14|||Chi-squared|||Superiority of adding bevacizumab to chemotherapy was tested as follows - H0: OR(FOLFOX-4+BV/XELOX+BV)/(FOLFOX-4+P/XELOX+P) \</= 1.0 versus H1: OR(FOLFOX-4+BV/XELOX+BV)/(FOLFOX-4+P/XELOX+P) \> 1.0. The test used a two-sided significance level of 2.5%.||1.14|0.71|0.3091
71098627|NCT00676689|141705674|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier|0.941|STANDARD_ERROR_OF_MEAN|0.028|||TWO_SIDED|95.0|0.851|0.978||||||Freedom from Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) at 6 months in the valve implant population.||0.978|0.851|
70989221|NCT00069095|141487157|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was based on the two-sided 97.5% confidence interval for OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV). Non-inferiority of XELOX with/without bevacizumab to FOLFOX-4 with/without bevacizumab shall be concluded if the lower limit of this confidence interval is above 0.66.|Odds Ratio (OR)|0.94|||||TWO_SIDED|97.5|0.76|1.16||||||Non-inferiority of XELOX with/without bevacizumab to FOLFOX-4 with/without bevacizumab was tested by the pair of hypotheses - H0: OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV) \</= 0.66 versus H1: OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV) \> 0.66||1.16|0.76|
70989222|NCT00069095|141487158|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.9887|TWO_SIDED|97.5|0.78|1.28|||Chi-squared|||Superiority of adding bevacizumab to chemotherapy was tested as follows - H0: OR(FOLFOX-4+BV/XELOX+BV)/(FOLFOX 4+P/XELOX+P) \</= 1.0 versus H1: OR(FOLFOX-4+BV/XELOX+BV)/(FOLFOX-4+P/XELOX+P) \> 1.0. The test used a two-sided significance level of 2.5%||1.28|0.78|0.9887
70989223|NCT00069095|141487159|NON_INFERIORITY_OR_EQUIVALENCE|No formal statistical testing was done.|Hazard Ratio (HR)|1.08|||||TWO_SIDED|97.5|0.97|1.2||||||General approach: HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV)||1.20|0.97|
70989224|NCT00069095|141487159|NON_INFERIORITY_OR_EQUIVALENCE|Fewer events were expected in analyses using the on-treatment approach than in the analyses using the general approach, thus leading to reduced power.Therefore, no formal statistical testing was performed.|Hazard Ratio (HR)|1.1|||||TWO_SIDED|97.5|0.98|1.23||||||On-treatment Approach: HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV).||1.23|0.98|
70989225|NCT00069095|141487160|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.003|TWO_SIDED|97.5|0.74|0.96|||Log Rank|||General approach: Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||0.96|0.74|0.0030
70989226|NCT00069095|141487160|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.0004|TWO_SIDED|97.5|0.7|0.92|||Log Rank|||On treatment approach: Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||0.92|0.70|0.0004
70989227|NCT00069095|141487163|NON_INFERIORITY_OR_EQUIVALENCE|No formal statistical testing was performed for duration of overall response.|Hazard Ratio (HR)|1.02|||||TWO_SIDED|97.5|0.86|1.22||||||HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV)||1.22|0.86|
70989228|NCT00069095|141487164|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.0307|TWO_SIDED|97.5|0.66|1.01|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||1.01|0.66|0.0307
70989229|NCT00069095|141487165|NON_INFERIORITY_OR_EQUIVALENCE|No formal statistical testing was done.|Hazard Ratio (HR)|0.35|||||TWO_SIDED|97.5|0.09|1.39||||||HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV).||1.39|0.09|
70989230|NCT00069095|141487166|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.8207|TWO_SIDED|97.5|0.2|7.05|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||7.05|0.20|0.8207
70989231|NCT01071044|141487170|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0|||||ANOVA|These data were initially analyzed with a one-way ANOVA.||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||.005
70989232|NCT01071044|141487171|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|TWO_SIDED|95.0|||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||0.008
71098628|NCT00676689|141705675|SUPERIORITY_OR_OTHER_LEGACY||Percentage|87.9|||||TWO_SIDED|||||||||Overall functional improvement at 6 months for patients in the valve implant population with baseline and 6 month data.||||
71098629|NCT00563316|141705685|NON_INFERIORITY_OR_EQUIVALENCE|It would be concluded that panitumumab did not have a clinically important effect on the pharmacokinetics of irinotecan if the 90% confidence intervals of the ratio of geometric means for the Cmax and AUC values for irinotecan with and without concomitant panitumumab administration fell within the interval of 70% to 143%.|Least Squares Geometric Mean Ratio|0.98|||||TWO_SIDED|90.0|0.894|1.074|||||Ratio of Cycle 2 : Cycle 1|||1.074|0.894|
70989233|NCT01071044|141487172|SUPERIORITY_OR_OTHER_LEGACY|||||||0.183||95.0|||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||0.183
70989234|NCT01071044|141487173|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046||95.0|||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||0.046
70989235|NCT01071044|141487174|SUPERIORITY_OR_OTHER_LEGACY|||||||0.219||95.0|||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||0.219
70989236|NCT01071044|141487175|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038||95.0|||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||0.038
70989237|NCT01071044|141487176|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0|||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||0.022
70989238|NCT02439281|141487191|OTHER|||||||0.451|||||||Wilcoxon (Mann-Whitney)|||||||0.4510
70989239|NCT02439281|141487192|OTHER|||||||0.8914|||||||Wilcoxon (Mann-Whitney)|||||||0.8914
70989240|NCT02439281|141487195|OTHER|||||||0.9531|||||||Wilcoxon (Mann-Whitney)|||||||0.9531
70989241|NCT02439281|141487196|OTHER|||||||0.778|||||||Wilcoxon (Mann-Whitney)|||||||0.7780
70989242|NCT02439281|141487197|OTHER|||||||0.5692|||||||Wilcoxon (Mann-Whitney)|||||||0.5692
70989243|NCT00358917|141487198|NON_INFERIORITY_OR_EQUIVALENCE|The 95% confidence interval for the difference in response rates (once daily \[QD\] minus twice daily \[BID\], based on the normal approximation to the binomial distribution) was used to assess noninferiority. The QD regimen was considered noninferior to the BID regimen if the lower limit of the confidence interval remained above -12%.|Diff. in Percentage of Subj. Responding|3.5||||0.413||95.0|-4.5|11.5|||normal approx. to binomial distribution|||The null hypothesis was that the response rate for the once daily (QD) regimen was more than 12% lower than the response rate for the twice daily (BID) regimen. The planned sample size of 600 participants (300 participants in each of the QD and BID treatment regimens) provided 83% power (with a type I error rate of 0.05) to reject the null hypothesis, i.e., to determine noninferiority based on the 12% margin.||11.5|-4.5|0.413
70989244|NCT00358917|141487199|SUPERIORITY_OR_OTHER||Diff. in Percentage of Subj. Responding|3.8||||0.389||95.0|-4.3|11.9|||normal approx. to binomial distribution|||||11.9|-4.3|0.389
70989245|NCT00358917|141487200|SUPERIORITY_OR_OTHER|||||||0.281||95.0|||||ANOVA|||||||0.281
70989246|NCT00358917|141487202|SUPERIORITY_OR_OTHER|||||||0.222||95.0|||||Fisher Exact|||||||0.222
70989247|NCT05372575|141487212|SUPERIORITY|The 2-sided 95% confidential interval (CI) on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|Geometric Mean Ratio (GMR)|13.16|||||TWO_SIDED|95.0|8.99|19.28|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|Geometric mean ratio (GMR) of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 1||19.28|8.99|
70989248|NCT05372575|141487212|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|5.88|||||TWO_SIDED|95.0|4.32|8.01|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 3||8.01|4.32|
70989249|NCT05372575|141487212|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|17.98|||||TWO_SIDED|95.0|12.07|26.78|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 4||26.78|12.07|
70989250|NCT05372575|141487212|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|2.42|||||TWO_SIDED|95.0|1.9|3.08|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 5||3.08|1.90|
70989251|NCT05372575|141487212|SUPERIORITY|The 2-sided 95% CI on GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|6.35|||||TWO_SIDED|95.0|4.68|8.61|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 6A||8.61|4.68|
70989252|NCT05372575|141487212|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|6.64|||||TWO_SIDED|95.0|4.92|8.97|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 6B||8.97|4.92|
70989253|NCT05372575|141487212|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|9.42|||||TWO_SIDED|95.0|6.91|12.83|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 7F||12.83|6.91|
70989254|NCT05372575|141487212|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|3.89|||||TWO_SIDED|95.0|2.96|5.1|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 9V||5.10|2.96|
71038794|NCT00577655|141584981|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.496||||0.0138|TWO_SIDED|95.0|0.729|6.262||In order to control the overall alpha level at the 0.05 value, each of the primary endpoints were tested separately at the 0.025 level of significance.|ANCOVA|Baseline as covariate and fixed effects of treatment and pooled investigator site.|Active - Placebo|Efficacy was declared if the test for either primary efficacy endpoint was significant at the 0.025 level.||6.262|0.729|0.0138
70989255|NCT05372575|141487212|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|62.13|||||TWO_SIDED|95.0|40.16|96.12|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 14||96.12|40.16|
70989256|NCT05372575|141487212|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|16.37|||||TWO_SIDED|95.0|11.22|23.89|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 18C||23.89|11.22|
70989257|NCT05372575|141487212|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|4.25|||||TWO_SIDED|95.0|3.22|5.62|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 19A||5.62|3.22|
70989258|NCT05372575|141487212|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|8.73|||||TWO_SIDED|95.0|6.24|12.21|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 19F||12.21|6.24|
70989259|NCT05372575|141487212|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|8.33|||||TWO_SIDED|95.0|6.15|11.29|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 23F||11.29|6.15|
70989260|NCT05372575|141487213|SUPERIORITY|The 2-sided 95% CI on the GMR (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|Geometric Mean Ratio (GMR)|4.78|||||TWO_SIDED|95.0|2.32|9.86|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 1||9.86|2.32|
70989261|NCT05372575|141487213|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|9.06|||||TWO_SIDED|95.0|4.72|17.39|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 3||17.39|4.72|
70989262|NCT05372575|141487213|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|14.37|||||TWO_SIDED|95.0|6.25|33.05|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 4||33.05|6.25|
70989263|NCT05372575|141487213|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|18.03|||||TWO_SIDED|95.0|8.84|36.8|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 5||36.80|8.84|
70989264|NCT05372575|141487213|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|33.88|||||TWO_SIDED|95.0|14.33|80.13|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 6A||80.13|14.33|
71038795|NCT00577655|141584982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.431||||0.0403|TWO_SIDED|95.0|0.244|10.618||In order to control the overall alpha level at the 0.05 value, each of the primary endpoints were tested separately at the 0.025 level of significance.|ANCOVA|Baseline as covariate and fixed effects of treatment and pooled investigator site.|Active - Placebo|Efficacy was declared if the test for either primary efficacy endpoint was significant at the 0.025 level.||10.618|0.244|0.0403
71098630|NCT00563316|141705686|NON_INFERIORITY_OR_EQUIVALENCE|It would be concluded that panitumumab did not have a clinically important effect on the pharmacokinetics of irinotecan if the 90% confidence intervals of the ratio of geometric means for the Cmax and AUC values for irinotecan with and without concomitant panitumumab administration fell within the interval of 70% to 143%.|Least Squares Geometric Mean Ratio|0.898|||||TWO_SIDED|90.0|0.819|0.985|||||Ratio of Cycle 2 : Cycle 1|||0.985|0.819|
70989265|NCT05372575|141487213|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|14.05|||||TWO_SIDED|95.0|6.07|32.52|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 6B||32.52|6.07|
70989266|NCT05372575|141487213|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|16.99|||||TWO_SIDED|95.0|7.85|36.76|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 7F||36.76|7.85|
70989267|NCT05372575|141487213|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|19.31|||||TWO_SIDED|95.0|9.13|40.84|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 9V||40.84|9.13|
70989268|NCT05372575|141487213|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|10.46|||||TWO_SIDED|95.0|4.74|23.1|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 14||23.10|4.74|
70989269|NCT05372575|141487213|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|12.13|||||TWO_SIDED|95.0|6.0|24.51|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 18C||24.51|6.00|
70989270|NCT05372575|141487213|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|23.65|||||TWO_SIDED|95.0|10.94|51.1|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 19A||51.10|10.94|
70989271|NCT05372575|141487213|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|17.62|||||TWO_SIDED|95.0|8.65|35.93|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 19F||35.93|8.65|
70989272|NCT05372575|141487213|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|44.46|||||TWO_SIDED|95.0|19.11|103.43|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 23F||103.43|19.11|
70989273|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|Geometric Mean Ratio (GMR)|0.48|||||TWO_SIDED|95.0|0.16|1.42|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 1||1.42|0.16|
70989274|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.74|||||TWO_SIDED|95.0|0.27|1.98|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 3||1.98|0.27|
70989275|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.68|||||TWO_SIDED|95.0|0.21|2.19|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 4||2.19|0.21|
70989276|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.82|||||TWO_SIDED|95.0|0.36|1.86|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 5||1.86|0.36|
70989277|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.68|||||TWO_SIDED|95.0|0.25|1.89|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 6A||1.89|0.25|
70989278|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.74|||||TWO_SIDED|95.0|0.27|2.07|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 6B||2.07|0.27|
71098631|NCT00563316|141705687|NON_INFERIORITY_OR_EQUIVALENCE|It would be concluded that panitumumab did not have a clinically important effect on the pharmacokinetics of irinotecan if the 90% confidence intervals of the ratio of geometric means for the Cmax and AUC values for irinotecan with and without concomitant panitumumab administration fell within the interval of 70% to 143%.|Least Squares Geometric Mean Ratio|0.897|||||TWO_SIDED|90.0|0.818|0.983|||||Ratio of Cycle 2 : Cycle 1|||0.983|0.818|
71098632|NCT00063232|141705755|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||paired t-test|||"self-controlled comparison of NASH activity index at 48 weeks and baseline. Null hypothesis is no change."||||<0.001
71098633|NCT00063232|141705756|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Fisher Exact|||self-controlled comparison of serum aminotransferase levels at 48 weeks and baseline. Null hypothesis: No change||||0.04
71098634|NCT00063232|141705757|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||paired t-test|||||||0.04
71098635|NCT03339453|141705758|NON_INFERIORITY|95% Confidence Interval of the treatment differences in treatment success rate.|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-1.52|1.52||||||||1.52|-1.52|
71098636|NCT02151604|141705785|OTHER||Pearson's coefficient|-0.57||||0.041|TWO_SIDED||||||Pearson's correlation analysis|||Correlation with field of irradiation||||0.041
71098637|NCT02151604|141705787|OTHER||Pearson's coefficient|0.6||||0.037|TWO_SIDED|||||Pearson's correlation coefficient: 0.60|Pearson's Correlation Analysis|0.60||Correlation of change in ventilation signal with that of alveolar volume (VA)||||0.037
70989279|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.42|||||TWO_SIDED|95.0|0.16|1.09|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 7F||1.09|0.16|
71098638|NCT02151604|141705787|OTHER||Pearson's correlation coefficient|0.7||||0.012|TWO_SIDED||||||Pearson's correlation analysis|Pearson's correlation coefficient: 0.70||Correlation of change in ventilation signal with that of diffusing capacity for carbon monoxide(TLCO)||||0.012
70989280|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.8|||||TWO_SIDED|95.0|0.35|1.81|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 9V||1.81|0.35|
70989281|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.66|||||TWO_SIDED|95.0|0.2|2.24|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 14||2.24|0.20|
70989282|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.6|||||TWO_SIDED|95.0|0.22|1.65|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 18C||1.65|0.22|
70989283|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|1.55|||||TWO_SIDED|95.0|0.61|3.93|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 19A||3.93|0.61|
70989284|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|1.8|||||TWO_SIDED|95.0|0.65|4.99|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 19F||4.99|0.65|
71098639|NCT02151604|141705787|OTHER||Pearson's correlation coefficient|-0.85||||0.032|TWO_SIDED||||||Pearson's correlation analysis|R = -0.85||Correlation of change in ventilation signal with that of residual volume (RV)||||0.032
71098640|NCT02151604|141705787|OTHER||Pearson's correlation coefficient|-0.95||||0.004|TWO_SIDED||||||Pearson's correlation analysis|R = -0.95||Correlation of change in ventilation signal with that of functional residual capacity (FRC)||||0.004
71098641|NCT02151604|141705787|OTHER||Pearson's correlation coefficient|-0.88||||0.012|TWO_SIDED||||||Pearson's correlation analysis|Pearson's correlation coefficient = -0.88||Correlation of change in ventilation signal with that of inspiratory capacity(IC)||||0.012
71098642|NCT00944645|141705802|NON_INFERIORITY_OR_EQUIVALENCE|Primary research hypothesis I: The Cmax of nicotinuric acid (NUA) following the administration of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) tablets from 2 manufacturing sites is similar (i.e., the true GMR of NUA Cmax is contained within the bioequivalence interval (0.80, 1.25)).|Geometric Mean Ratio|0.98||||||90.0|0.93|1.03||||||"MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) tablet from new manufacturing site (Source 2)~MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) Phase III tablet (Source 1)"||1.03|0.93|
71098643|NCT00944645|141705803|NON_INFERIORITY_OR_EQUIVALENCE|Primary research hypothesis II: The total urinary excretion of niacin and niacin metabolites following the administration of MK0524 (ER niacin 1000 mg/ laropiprant 20 mg) tablets from 2 manufacturing sites is similar (i.e., the true GMR of total urinary excretion of niacin and its metabolites is contained within the bioequivalence interval (0.80, 1.25)).|Geometric Mean Ratio|0.94||||||90.0|0.89|0.98||||||"MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) tablet from new manufacturing site (Source 2)~MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) Phase III tablet (Source 1)"||0.98|0.89|
70989285|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.47|||||TWO_SIDED|95.0|0.17|1.31|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 23F||1.31|0.17|
70989286|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.65|||||TWO_SIDED|95.0|0.31|1.38|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 1||1.38|0.31|
70989287|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.7|||||TWO_SIDED|95.0|0.4|1.24|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 3||1.24|0.40|
70989288|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.73|||||TWO_SIDED|95.0|0.33|1.59|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 4||1.59|0.33|
70989289|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.8|||||TWO_SIDED|95.0|0.52|1.25|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 5||1.25|0.52|
70989290|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.93|||||TWO_SIDED|95.0|0.57|1.52|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 6A||1.52|0.57|
70989291|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|1.53|||||TWO_SIDED|95.0|0.95|2.47|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 6B||2.47|0.95|
70989292|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.74|||||TWO_SIDED|95.0|0.41|1.34|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 7F||1.34|0.41|
70989293|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.73|||||TWO_SIDED|95.0|0.34|1.57|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 9V||1.57|0.34|
70989294|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.44|||||TWO_SIDED|95.0|0.16|1.18|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 14||1.18|0.16|
70989295|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.59|||||TWO_SIDED|95.0|0.25|1.4|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 18C||1.40|0.25|
70989296|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.79|||||TWO_SIDED|95.0|0.5|1.23|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 19A||1.23|0.50|
70989297|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|1.14|||||TWO_SIDED|95.0|0.6|2.18|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 19F||2.18|0.60|
70989298|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|1.08|||||TWO_SIDED|95.0|0.68|1.72|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 23F||1.72|0.68|
70989299|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|10.3|||||TWO_SIDED|95.0|2.44|43.49|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 1||43.49|2.44|
70989300|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|6.17|||||TWO_SIDED|95.0|2.07|18.42|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 3||18.42|2.07|
70989301|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|18.7|||||TWO_SIDED|95.0|4.35|80.37|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 4||80.37|4.35|
70989302|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|2.5|||||TWO_SIDED|95.0|1.14|5.52|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 5||5.52|1.14|
70989303|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|5.24|||||TWO_SIDED|95.0|2.33|11.8|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 6A||11.80|2.33|
70989304|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|3.77|||||TWO_SIDED|95.0|1.47|9.65|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 6B||9.65|1.47|
70989305|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|5.94|||||TWO_SIDED|95.0|1.65|21.36|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 7F||21.36|1.65|
70989306|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|4.44|||||TWO_SIDED|95.0|1.17|16.87|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 9V||16.87|1.17|
70989307|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|90.8|||||TWO_SIDED|95.0|16.67|494.56|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 14||494.56|16.67|
70989308|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|17.83|||||TWO_SIDED|95.0|3.79|83.78|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 18C||83.78|3.79|
70989309|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|8.11|||||TWO_SIDED|95.0|3.6|18.3|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 19A||18.30|3.60|
70989310|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|15.29|||||TWO_SIDED|95.0|4.64|50.35|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 19F||50.35|4.64|
70989311|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|4.19|||||TWO_SIDED|95.0|1.72|10.25|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 23F||10.25|1.72|
70989312|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|13.93|||||TWO_SIDED|95.0|9.14|21.23|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 1||21.23|9.14|
71098644|NCT00944645|141705804|NON_INFERIORITY_OR_EQUIVALENCE|Primary research hypothesis III: The AUC0-infinity of laropiprant following the administration of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) tablets from 2 manufacturing sites is similar (i.e., the true GMR of MK0524 AUC0-∞ is contained within the bioequivalence interval (0.80, 1.25)).|Geometric Mean Ratio|1.0||||||95.0|0.95|1.05||||||"Group B: MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) tablet from new manufacturing site (Source 2)~Group A: MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) Phase III tablet (Source 1)"||1.05|0.95|
70989313|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|5.86|||||TWO_SIDED|95.0|4.17|8.24|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 3||8.24|4.17|
70989314|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|19.97|||||TWO_SIDED|95.0|12.8|31.15|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 4||31.15|12.80|
70989315|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|2.46|||||TWO_SIDED|95.0|1.87|3.24|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 5||3.24|1.87|
70989316|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|7.12|||||TWO_SIDED|95.0|5.05|10.03|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 6A||10.03|5.05|
70989317|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|7.78|||||TWO_SIDED|95.0|5.54|10.92|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 6B||10.92|5.54|
70989318|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|10.4|||||TWO_SIDED|95.0|7.4|14.61|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 7F||14.61|7.40|
70989319|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|4.07|||||TWO_SIDED|95.0|3.04|5.47|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 9V||5.47|3.04|
70989320|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|60.32|||||TWO_SIDED|95.0|37.25|97.67|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 14||97.67|37.25|
70989321|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|17.35|||||TWO_SIDED|95.0|11.37|26.47|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 18C||26.47|11.37|
71098645|NCT00944645|141705805|NON_INFERIORITY_OR_EQUIVALENCE|Primary research hypothesis IV: The Cmax of laropiprant following the administration of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) tablets from 2 manufacturing sites is similar (i.e., the true GMR of MK0524 Cmax is contained within the bioequivalence interval (0.80, 1.25)).|Geometric Mean Ratio|1.02||||||95.0|0.96|1.09||||||"MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) tablet from new manufacturing site (Source 2)~MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) Phase III tablet (Source 1)"||1.09|0.96|
71098646|NCT03537729|141705806|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|0.19|<|0.01|TWO_SIDED|95.0|0.18|0.91||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Cues minus control|The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.||0.91|0.18|<.01
70989322|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|4.11|||||TWO_SIDED|95.0|3.0|5.62|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 19A||5.62|3.00|
70989323|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|9.68|||||TWO_SIDED|95.0|6.65|14.08|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 19F||14.08|6.65|
70989324|NCT05372575|141487214|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|9.7|||||TWO_SIDED|95.0|6.9|13.64|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 23F||13.64|6.90|
70989325|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.49|||||TWO_SIDED|95.0|0.06|3.91|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 1||3.91|0.06|
70989326|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.54|||||TWO_SIDED|95.0|0.1|2.92|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 3||2.92|0.10|
70989327|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.45|||||TWO_SIDED|95.0|0.1|2.07|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 4||2.07|0.10|
70989328|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.78|||||TWO_SIDED|95.0|0.27|11.75|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 5||11.75|0.27|
70989329|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.23|||||TWO_SIDED|95.0|0.03|1.65|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 6A||1.65|0.03|
70989330|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.06|||||TWO_SIDED|95.0|0.01|0.44|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 6B||0.44|0.01|
70989331|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.21|||||TWO_SIDED|95.0|0.56|2.65|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 7F||2.65|0.56|
70989332|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.2|||||TWO_SIDED|95.0|0.03|1.26|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 9V||1.26|0.03|
70989333|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.36|||||TWO_SIDED|95.0|0.08|1.55|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 14||1.55|0.08|
71038796|NCT00577655|141584983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.536||||0.0031|TWO_SIDED|95.0|1.567|7.505||significance level of 0.05.|Mixed Models Analysis||Active - Placebo|"Day 1~A repeated measures mixed model, with terms for treatment, pooled center, study day, treatment by study day interaction, and baseline as a covariate, and subject as a random term, was used to make comparisons between placebo and active with respect to FEV1max%0-2 at Days 1 and 22, with observed case data."||7.505|1.567|0.0031
70989334|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.82|||||TWO_SIDED|95.0|0.15|4.47|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 18C||4.47|0.15|
70989335|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.35|||||TWO_SIDED|95.0|0.19|9.44|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 19A||9.44|0.19|
70989336|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|3.87|||||TWO_SIDED|95.0|0.67|22.42|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 19F||22.42|0.67|
70989337|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.27|||||TWO_SIDED|95.0|0.05|1.52|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 23F||1.52|0.05|
70989338|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.76|||||TWO_SIDED|95.0|0.19|3.07|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 1||3.07|0.19|
70989339|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.02|||||TWO_SIDED|95.0|0.42|2.46|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 3||2.46|0.42|
70989340|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.44|||||TWO_SIDED|95.0|0.05|3.73|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 4||3.73|0.05|
70989341|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.63|||||TWO_SIDED|95.0|0.15|2.73|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 5||2.73|0.15|
70989342|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.88|||||TWO_SIDED|95.0|0.11|6.99|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 6A||6.99|0.11|
70989343|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.9|||||TWO_SIDED|95.0|0.29|12.51|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 6B||12.51|0.29|
70989344|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|2.45|||||TWO_SIDED|95.0|0.34|17.43|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 7F||17.43|0.34|
70989345|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.43|||||TWO_SIDED|95.0|0.27|7.7|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 9V||7.70|0.27|
70989346|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|2.3|||||TWO_SIDED|95.0|0.3|17.41|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 14||17.41|0.30|
70989347|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.65|||||TWO_SIDED|95.0|0.14|2.97|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 18C||2.97|0.14|
70989348|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.51|||||TWO_SIDED|95.0|0.28|8.21|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 19A||8.21|0.28|
70989349|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.63|||||TWO_SIDED|95.0|0.13|2.97|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 19F||2.97|0.13|
70989350|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.23|||||TWO_SIDED|95.0|0.15|10.24|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 23F||10.24|0.15|
70989351|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|3.15|||||TWO_SIDED|95.0|0.41|23.91|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 1||23.91|0.41|
70989352|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|5.02|||||TWO_SIDED|95.0|1.45|17.39|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 3||17.39|1.45|
70989353|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|13.7|||||TWO_SIDED|95.0|1.32|141.81|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 4||141.81|1.32|
70989354|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|48.41|||||TWO_SIDED|95.0|6.16|380.54|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 5||380.54|6.16|
70989355|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|10.47|||||TWO_SIDED|95.0|0.48|229.1|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 6A||229.10|0.48|
70989356|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.68|||||TWO_SIDED|95.0|0.02|19.83|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 6B||19.83|0.02|
70989357|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|10.53|||||TWO_SIDED|95.0|1.98|55.96|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 7F||55.96|1.98|
70989358|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|3.32|||||TWO_SIDED|95.0|0.19|56.82|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 9V||56.82|0.19|
70989359|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|2.0|||||TWO_SIDED|95.0|0.06|63.12|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 14||63.12|0.06|
70989360|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|16.31|||||TWO_SIDED|95.0|2.15|123.48|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 18C||123.48|2.15|
70989361|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|24.16|||||TWO_SIDED|95.0|1.59|367.81|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 19A||367.81|1.59|
70989362|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|95.06|||||TWO_SIDED|95.0|13.08|691.01|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 19F||691.01|13.08|
70989363|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|10.49|||||TWO_SIDED|95.0|0.64|171.84|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 23F||171.84|0.64|
70989364|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|4.86|||||TWO_SIDED|95.0|2.15|10.96|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 1||10.96|2.15|
70989365|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|9.57|||||TWO_SIDED|95.0|4.5|20.36|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 3||20.36|4.50|
70989366|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|13.4|||||TWO_SIDED|95.0|5.2|34.51|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 4||34.51|5.20|
70989367|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|17.15|||||TWO_SIDED|95.0|7.76|37.91|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 5||37.91|7.76|
70989368|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|40.2|||||TWO_SIDED|95.0|15.16|106.65|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 6A||106.65|15.16|
70989369|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|20.38|||||TWO_SIDED|95.0|8.39|49.51|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 6B||49.51|8.39|
70989370|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|21.22|||||TWO_SIDED|95.0|8.65|52.07|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 7F||52.07|8.65|
70989371|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|23.73|||||TWO_SIDED|95.0|10.39|54.19|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 9V||54.19|10.39|
70989372|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|12.84|||||TWO_SIDED|95.0|5.46|30.22|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 14||30.22|5.46|
70989373|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|12.88|||||TWO_SIDED|95.0|5.95|27.88|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 18C||27.88|5.95|
70989374|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|26.99|||||TWO_SIDED|95.0|11.46|63.58|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 19A||63.58|11.46|
70989375|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|15.53|||||TWO_SIDED|95.0|7.02|34.38|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 19F||34.38|7.02|
70989376|NCT05372575|141487215|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|48.73|||||TWO_SIDED|95.0|18.67|127.16|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 23F||127.16|18.67|
70989377|NCT01544595|141487216|SUPERIORITY|"H1: Secukinumab 150 mg was not different from placebo with respect to the cumulative rate for patients who lost PASI 75 response up to Week 68~• H2: Secukinumab 300 mg was not different from placebo with respect to the cumulative rate for patients who lost PASI 75 response up to Week 68"|Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.22|0.42|||Log Rank|||"The following hypotheses were tested for 52 weeks≤ t ≤68 weeks~* H1: p1(t) - p0,1(t) = 0 versus HA1: p1(t)- p0,1(t) ≥ 0,~* H2: p2(t) - p0,2(t) = 0 versus HA2: p2(t) - p0,2(t) ≥ 0,"||0.42|0.22|<0.0001
70989378|NCT01544595|141487216|SUPERIORITY|"H1: Secukinumab 150 mg was not different from placebo with respect to the cumulative rate for patients who lost PASI 75 response up to Week 68~• H2: Secukinumab 300 mg was not different from placebo with respect to the cumulative rate for patients who lost PASI 75 response up to Week 68"|Hazard Ratio (HR)|0.2|||<|0.0001|TWO_SIDED|95.0|0.14|0.29|||Log Rank|||"The following hypotheses were tested for 52 weeks≤ t ≤68 weeks~* H1: p1(t) - p0,1(t) = 0 versus HA1: p1(t)- p0,1(t) ≥ 0,~* H2: p2(t) - p0,2(t) = 0 versus HA2: p2(t) - p0,2(t) ≥ 0,"||0.29|0.14|<0.0001
70989379|NCT04415489|141487262|SUPERIORITY|||||||0.57||||||The a priori threshold for statistical significance was p \< 0.05.|Fisher Exact|||||||0.57
70989380|NCT04415489|141487263|SUPERIORITY||||||<|0.01||||||The a priori threshold for statistical significance was p \< 0.05.|t-test, 2 sided|||||||<0.01
70989381|NCT04415489|141487264|SUPERIORITY|||||||0.11||||||The a priori threshold for statistical significance was \< 0.05.|Fisher Exact|||||||0.11
70989382|NCT04415489|141487265|SUPERIORITY|||||||0.16||||||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||||||0.16
70989383|NCT04415489|141487266|SUPERIORITY||||||<|0.01||||||The a priori threshold for statistical significance was \< 0.05.|Fisher Exact|||||||< 0.01
71038797|NCT00577655|141584983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.067||||0.047|TWO_SIDED|95.0|0.041|6.094||significance level of 0.05.|Mixed Models Analysis||Active - Placebo|"Day 22~A repeated measures mixed model, with terms for treatment, pooled center, study day, treatment by study day interaction, and baseline as a covariate, and subject as a random term, was used to make comparisons between placebo and active with respect to FEV1max%0-2 at Days 1 and 22, with observed case data."||6.094|0.041|0.0470
71038798|NCT00577655|141584984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.572||||0.0074|TWO_SIDED|95.0|2.077|13.067||significance level of 0.05.|repeated measures ANOVA||Active - Placebo|"Day 1~A repeated measures mixed model, with terms for treatment, pooled center, study day, treatment by study day interaction, and baseline as a covariate, and subject as a random term, was used to make comparisons between placebo and active with respect to PEFmax%0-2 at Days 1 and 22, with observed case data."||13.067|2.077|0.0074
71038799|NCT00577655|141584984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.782||||0.1843|TWO_SIDED|95.0|-1.832|9.397||significance level of 0.05.|repeated measures ANOVA||Active - Placebo|"Day 22~A repeated measures mixed model, with terms for treatment, pooled center, study day, treatment by study day interaction, and baseline as a covariate, and subject as a random term, was used to make comparisons between placebo and active with respect to PEFmax%0-2 at Days 1 and 22, with observed case data."||9.397|-1.832|0.1843
70989384|NCT04415489|141487270|SUPERIORITY|||||||0.12||||||The a priori threshold for statistical significance was \< 0.05.|Fisher Exact|||||||0.12
70989385|NCT05319535|141487273|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.26|TWO_SIDED|95.0|-1.8|6.1|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); prior implementation of Caregivers First (yes vs. no)).||6.1|-1.8|0.26
70989386|NCT05319535|141487274|SUPERIORITY||rate ratio|1.7||||0.11|TWO_SIDED|95.0|0.9|3.4|||negative binomial regression|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); prior implementation of Caregivers First (yes vs. no)).||3.4|0.9|0.11
71038800|NCT00577655|141584985|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.707||||0.0507|TWO_SIDED|95.0|-0.03|19.445||significance level of 0.05.|ANCOVA|terms for treatment and center, baseline as a covariate|Active - Placebo|Day 22 Baseline||19.445|-0.030|0.0507
71038801|NCT00577655|141584985|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.892||||0.924|TWO_SIDED|95.0|-17.634|19.419||significance level of 0.05.|ANOVA|terms for treatment and center|Active - Placebo|Day 1 Baseline||19.419|-17.634|0.9240
71038802|NCT00577655|141584986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|30.124||||0.2186|TWO_SIDED|95.0|-18.169|78.417||significance level of 0.05.|ANCOVA|terms for treatment and center, baseline as a covariate|Active - Placebo|Day 22 Baseline||78.417|-18.169|0.2186
71098647|NCT03537729|141705806|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.18||0.96|TWO_SIDED|95.0|-0.35|0.37||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus control.|The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.||0.37|-0.35|.96
70989387|NCT05319535|141487275|SUPERIORITY||Mean Difference (Final Values)|37.6||||0.17|TWO_SIDED|95.0|-18.1|93.3|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); prior implementation of Caregivers First (yes vs. no)).||93.3|-18.1|0.17
70989388|NCT05319535|141487276|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.1|TWO_SIDED|95.0|-0.1|1.4|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); prior implementation of Caregivers First (yes vs. no)).||1.4|-0.1|0.10
70989389|NCT05319535|141487277|SUPERIORITY||rate ratio|1.3||||0.36|TWO_SIDED|95.0|0.7|2.3|||negative binomial regression|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); prior implementation of Caregivers First (yes vs. no)).||2.3|0.7|0.36
70989390|NCT05319535|141487278|SUPERIORITY||Odds Ratio (OR)|3.3||||0.17|TWO_SIDED|95.0|0.6|18.5|||Regression, Logistic|||Model included the arm indicator variable.||18.5|0.6|0.17
70989391|NCT01064648|141487280|OTHER||Hazard Ratio (HR)|0.71||||0.06|TWO_SIDED|80.0|0.54|0.95||1-sided p-value|Log Rank|Stratified log rank test by performance status and histology type.||||0.95|0.54|0.06
70989392|NCT01064648|141487281|OTHER||Hazard Ratio (HR)|0.88||||0.28|TWO_SIDED|80.0|0.65|1.17||1-sided p-value|Log Rank|Stratified log-rank test by performance status and histology.||||1.17|0.65|0.28
70989393|NCT01064648|141487282|OTHER||Odds Ratio (OR)|1.85||||0.15|TWO_SIDED|95.0|0.59|5.83||1-sided p-value|Chi-squared|Stratified Chi-square by performance status and histology.||||5.83|0.59|0.15
70989394|NCT01064648|141487283|OTHER||Odds Ratio (OR)|0.45||||0.09|TWO_SIDED|95.0|0.14|1.49||1-sided p-value|Chi-squared|Stratified Chi-Square by performance status and histology||||1.49|0.14|0.09
70989395|NCT01064648|141487284|OTHER||Odds Ratio (OR)|4.3||||0.006|TWO_SIDED|95.0|1.4|13.3||1-sided p-value|Chi-squared|Stratified Chi-Square by performance status and histology.||||13.3|1.4|0.006
70989396|NCT01064648|141487285|OTHER||Odds Ratio (OR)|0.59||||0.19|TWO_SIDED|95.0|0.18|1.94||1-sided p-value|Chi-squared|Stratified Chi-Square by performance status and histology||||1.94|0.18|0.19
70989397|NCT05299983|141487366|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<.001
70989398|NCT05299983|141487367|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||0.02
70989399|NCT05299983|141487368|SUPERIORITY|||||||0.22|||||||Chi-squared|||||||0.22
70989400|NCT05299983|141487369|SUPERIORITY|||||||0.45|||||||Chi-squared|||||||0.45
70989401|NCT00074412|141487378|SUPERIORITY_OR_OTHER_LEGACY||6 month Rate of Cum. HIV Infection (%)|1.1|||||TWO_SIDED|95.0|0.3|1.8|||Kaplan-Meier Method|||||1.8|0.3|
70989402|NCT00074412|141487378|SUPERIORITY_OR_OTHER_LEGACY||6 month Rate of Cum. HIV Infection (%)|2.4|||||TWO_SIDED|95.0|1.3|3.6|||Kaplan-Meier Method|||||3.6|1.3|
70989403|NCT00074412|141487378|SUPERIORITY_OR_OTHER_LEGACY||Z statistic|1.973||||0.049||95.0||||P-value has not been adjusted for interim analysis or multiple testing. A priori threshold for statistical significance was 0.05.|Z-test|||Assuming the cumulative HIV infection rate in placebo group would be 4.2% (2.6 at 6 wk. \& 6.7 at 6 mon.), we estimated 1500 mother/infant pairs would provide 90% power to detect a reduction in HIV infection from 4.2% to 1.4% at 6 mon. with a Pearson χ² test statistic and a one-sided false positive error rate of 0.025. Rate of cumulative infection was calculated using Kaplan-Meier method and rates between extended NVP group and placebo were done with the Z statistic.||||0.049
70989404|NCT00074412|141487380|SUPERIORITY_OR_OTHER_LEGACY||Cum. Rate of HIV-free Survival 6mon (%)|97.7|||||TWO_SIDED|95.0|96.6|98.8|||Kaplan-Meier Method|||The cumulative rate of HIV-free survival at 6 months in the extended NVP arm was calculated using the Kaplan-Meier method; while the 95% CI was calculated using Greenwood's formula.||98.8|96.6|
70989405|NCT00074412|141487380|SUPERIORITY_OR_OTHER_LEGACY||Cum. Rate of HIV-free Survival 6mon (%)|96.8|||||TWO_SIDED|95.0|95.5|98.0|||Kaplan-Meier Method|||The cumulative rate of HIV-free survival at 6 months in the placebo arm was calculated using the Kaplan-Meier method; while the 95% CI was calculated using Greenwood's formula.||98.0|95.5|
70989406|NCT00074412|141487380|SUPERIORITY_OR_OTHER_LEGACY||Z statistic|1.095||||0.274||95.0||||P-value was not adjusted for interim analysis or multiple testing.|Z-test|||The cumulative rates of HIV-free survival at 6 months were compared between the two groups using a Z-statistic.||||0.274
70989407|NCT00074412|141487380|SUPERIORITY_OR_OTHER_LEGACY||Cum. Rate of HIV-free Survival 18mon (%)|94.5|||||TWO_SIDED|95.0|92.9|96.2|||Kaplan-Meier Method|||The cumulative rate of HIV-free survival at 18 months in the extended NVP arm was calculated using the Kaplan-Meier method; while 95% confidence intervals were calculated using Greenwood's formula.||96.2|92.9|
70989408|NCT00074412|141487380|SUPERIORITY_OR_OTHER_LEGACY||Cum. Rate of HIV-free Survival 18mon (%)|93.3|||||TWO_SIDED|95.0|91.5|95.1|||Kaplan-Meier Method|||The cumulative rate of HIV-free survival at 18 months in the placebo arm was calculated using the Kaplan-Meier method; while the 95% confidence interval was calculated using Greenwood's formula.||95.1|91.5|
70989409|NCT00074412|141487380|SUPERIORITY_OR_OTHER_LEGACY||Z statistic|0.988||||0.323||95.0||||P-value was not adjusted for interim analysis or multiple testing.|Z-test|||The cumulative rates of HIV-free survival at 18 months were compared between the two groups using a Z statistic.||||0.323
70989410|NCT00074412|141487381|SUPERIORITY_OR_OTHER_LEGACY||18 mon. Rate of Cum HIV Infection (%)|2.2|||||TWO_SIDED|95.0|1.1|3.3|||Kaplan-Meier Method|||The cumulative rate of HIV infection at 18 months in the extended NVP arm was calculated using the Kaplan-Meier method; while the 95% confidence interval was calculated using Greenwood's formula.||3.3|1.1|
70989411|NCT00074412|141487381|SUPERIORITY_OR_OTHER_LEGACY||18 mon. Rate of Cum. HIV Infection (%)|3.1|||||TWO_SIDED|95.0|1.9|4.4|||Kaplan-Meier Method|||The cumulative rate of HIV infection at 18 months in the placebo arm was calculated using the Kaplan-Meier method; while the 95% confidence interval was calculated using Greenwood's formula.||4.4|1.9|
70989412|NCT00074412|141487381|SUPERIORITY_OR_OTHER_LEGACY||Z statistic|1.081||||0.28||95.0||||P-value was not adjusted for interim analysis or multiple testing.|Z-test|||The cumulative rates of HIV infection at 18 months were calculated using the Kaplan-Meier method and were compared between arms using a Z statistic.||||0.280
70989413|NCT00074412|141487382|SUPERIORITY_OR_OTHER_LEGACY||Cumulative Mortality Rate at 18mon (%)|4.7|||||TWO_SIDED|95.0|2.0|7.4|||Kaplan-Meier Method|||||7.4|2.0|
70989414|NCT00074412|141487382|SUPERIORITY_OR_OTHER_LEGACY||Cumulative Mortality Rate at 18mon (%)|4.1|||||TWO_SIDED|95.0|2.7|5.6|||Kaplan-Meier Method|||||5.6|2.7|
70989415|NCT00074412|141487382|SUPERIORITY_OR_OTHER_LEGACY||Z statistic|-0.247||||0.805||95.0||||P-value was not adjusted for interim analysis or multiple testing|Z-test|||The cumulative rates of mortality at 6 months, as calculated by Kaplan-Meier, were compared between the two groups using a Z-statistic.||||0.805
70989416|NCT00074412|141487382|SUPERIORITY_OR_OTHER_LEGACY||Cumulative Mortality Rate at 6mon (%)|1.2|||||TWO_SIDED|95.0|0.4|2.0|||Kaplan-Meier Method|||||2.0|0.4|
70989417|NCT00074412|141487382|SUPERIORITY_OR_OTHER_LEGACY||Cumulative Mortality Rate at 6mon (%)|1.1|||||TWO_SIDED|95.0|0.3|1.8|||Kaplan-Meier Method|||||1.8|0.3|
70989418|NCT00074412|141487382|SUPERIORITY_OR_OTHER_LEGACY||Z statistic|-0.36||||0.719||95.0||||P-value was not adjusted for interim analysis or multiple testing.|Z-test|||The cumulative mortality rates at 18 months, as calculated by Kaplan-Meier, were compared between the two groups using a Z statistic.||||0.719
70989419|NCT00074412|141487382|SUPERIORITY_OR_OTHER_LEGACY|||||||0.611||95.0|||||Log Rank|||We compared the cumulative mortality rates, as calculated using Kaplan-Meier, between the two study groups over all 18 months of the study follow-up using a log-rank test.||||0.611
70989420|NCT02891798|141487383|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||Comparison of SF-MPQ2 Total Score Difference From Baseline between the 4-drug nerve block group and the bupivacaine only group||||0.003
70989421|NCT02891798|141487384|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Comparison of SF-MPQ2 Continuous Pain Subscore Difference From Baseline between the 4-drug nerve block group and the bupivacaine only group||||0.001
70989422|NCT02891798|141487385|SUPERIORITY|||||||0.038|||||||t-test, 2 sided|||Comparison of SF-MPQ2 Intermittent Pain Subscore Difference From Baseline between the 4-drug nerve block group and the bupivacaine only group||||0.038
70989423|NCT02891798|141487386|SUPERIORITY|||||||0.009|||||||t-test, 2 sided|||Comparison of QoR-15 Total Score at post-operative day 1 between the 4-drug nerve block group and the bupivacaine only group||||0.009
70989424|NCT02891798|141487387|NON_INFERIORITY|Testing the null hypothesis that Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone) does not adversely affect recovery by producing a significantly lower score for the QoR-15 Total Score.||||||0.861|||||||t-test, 2 sided|||Comparison of QoR-15 Total Score at 6 week post-procedure between the 4-drug nerve block group and the bupivacaine only group||||0.861
70989425|NCT02891798|141487388|NON_INFERIORITY|Testing the null hypothesis that Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone) does not adversely affect recovery by producing a significantly lower score for the Standing Balance test.||||||0.512|||||||t-test, 2 sided|||Comparison of Standing Balance Test score at 6 week post-procedure between the 4-drug nerve block group and the bupivacaine only group||||0.512
70989426|NCT02891798|141487389|NON_INFERIORITY|Testing the null hypothesis that Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone) does not adversely affect recovery by producing a significantly slower rate for the Self-Selected Gait Speed test.||||||0.339|||||||t-test, 2 sided|||Comparison of Self-Selected Gait Speed rate at 6 week post-procedure between the 4-drug nerve block group and the bupivacaine only group.||||0.339
70989427|NCT02891798|141487390|NON_INFERIORITY|Testing the null hypothesis that Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone) does not adversely affect recovery by producing a significantly slower time for the Repeated Chair Stand test.||||||0.711|||||||t-test, 2 sided|||Comparison of Repeated Chair Stand time at 6 week post-procedure between the 4-drug nerve block group and the bupivacaine only group.||||0.711
70989428|NCT00418834|141487399|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.8|STANDARD_ERROR_OF_MEAN|1.1|<|0.001||95.0|-16.0|-11.7|||ANCOVA|Model terms: treatment, baseline LDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-11.7|-16.0|<0.001
70989429|NCT00418834|141487400|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-7.4|-1.8|||ANCOVA|Model terms: treatment, baseline LDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-1.8|-7.4|<0.001
70989430|NCT00418834|141487401|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.32|||<|0.001||95.0|4.52|8.84|||Regression, Logistic|Model terms: treatment, baseline LDL-C, and AVD status|Estimated ratio is the predictive odds of attaining LDL-C target on Atorva 10 mg + EZ versus Atorva 20 mg|||8.84|4.52|<0.001
70989431|NCT00418834|141487402|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.87|||<|0.001||95.0|1.4|2.5|||Regression, Logistic|Model terms: treatment, baseline LDL-C, and AVD status|Estimated ratio is the predictive odds of attaining LDL-C target on Atorva 10 mg + EZ versus Atorva 20 mg / Atorva 40 mg|||2.50|1.40|<0.001
70989432|NCT00418834|141487403|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.48|||<|0.001||95.0|3.98|7.55|||Regression, Logistic|Model terms: treatment, baseline LDL-C, and AVD status|Estimated ratio is the predictive odds of attaining LDL-C target on Atorva 10 mg + EZ versus Atorva 20 mg|||7.55|3.98|<0.001
70989433|NCT00418834|141487404|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.75|||<|0.001||95.0|1.32|2.31|||Regression, Logistic|Model terms: treatment, baseline LDL-C, and AVD status|Estimated ratio is the predictive odds of attaining LDL-C target on Atorva 10 mg + EZ versus Atorva 20 mg / Atorva 40 mg|||2.31|1.32|<0.001
70989434|NCT00418834|141487405|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.8|<|0.001||95.0|0.3|3.5|||ANCOVA|Model terms: treatment, baseline HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||3.5|0.3|<0.001
70989435|NCT00418834|141487406|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|0.8|<|0.001||95.0|1.5|4.8|||ANCOVA|Model terms: treatment, baseline HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||4.8|1.5|<0.001
70989436|NCT00418834|141487407|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|1.0|<|0.001||95.0|-14.2|-10.3|||ANCOVA|Model terms: treatment, baseline non-HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-10.3|-14.2|<0.001
70989437|NCT00418834|141487408|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|1.3|<|0.001||95.0|-6.8|-1.7|||ANCOVA|Model terms: treatment, baseline non-HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-1.7|-6.8|<0.001
70989438|NCT00418834|141487409|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|0.7|<|0.001||95.0|-9.4|-6.5|||ANCOVA|Model terms: treatment, baseline Total Cholesterol, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-6.5|-9.4|<0.001
70989439|NCT00418834|141487410|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001||95.0|-3.8|-0.2|||ANCOVA|Model terms: treatment, baseline Total Cholesterol, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||-0.2|-3.8|<0.001
70989440|NCT00418834|141487411|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-6.2|||<|0.001||95.0|-9.0|-3.4|||Nonparametric ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment, baseline TG value (normalized scores), and AVD status|"(Atorva 10 mg + EZ minus Atorva 20 mg)~The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic"|||-3.4|-9.0|<0.001
70989441|NCT00418834|141487412|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-2.1|||<|0.001||95.0|-5.2|1.0|||Nonparametric ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment, baseline TG value (normalized scores), and AVD status|"(Atorva 10 mg + EZ minus Atorva 20 mg)~The median difference is based on the Hodges-Lehmann estimates~of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic"|||1.0|-5.2|<0.001
70989442|NCT00418834|141487413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.1|STANDARD_ERROR_OF_MEAN|0.9|<|0.001||95.0|-11.0|-7.3|||ANCOVA|Model terms: treatment, baseline Apo B, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-7.3|-11.0|<0.001
70989443|NCT00418834|141487414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-5.5|-0.9|||ANCOVA|Model terms: treatment, baseline Apo B, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||-0.9|-5.5|<0.001
71098648|NCT03537729|141705806|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.18|<|0.01|TWO_SIDED|95.0|-0.89|-0.18||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus cues only|The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.||-0.18|-0.89|<.01
70989444|NCT00418834|141487415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.8||0.401||95.0|-0.9|2.1|||ANCOVA|Model terms: treatment, baseline Apo A-I, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||2.1|-0.9|0.401
70989445|NCT00418834|141487416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|0.8|<|0.001||95.0|1.1|4.2|||ANCOVA|Model terms: treatment, baseline Apo A-I, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||4.2|1.1|<0.001
70989446|NCT00418834|141487417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001||95.0|-10.7|-7.3|||ANCOVA|Model terms: treatment, baseline Total-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-7.3|-10.7|<0.001
70989447|NCT00418834|141487418|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.1|<|0.001||95.0|-6.8|-2.4|||ANCOVA|Model terms: treatment, baseline Total-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||-2.4|-6.8|<0.001
70989448|NCT00418834|141487419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.6|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-17.0|-12.2|||ANCOVA|Model terms: treatment, baseline LDL-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-12.2|-17.0|<0.001
70989449|NCT00418834|141487420|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|1.7|<|0.001||95.0|-10.1|-3.7|||ANCOVA|Model terms: treatment, baseline LDL-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||-3.7|-10.1|<0.001
70989450|NCT00418834|141487421|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.5|STANDARD_ERROR_OF_MEAN|1.0|<|0.001||95.0|-11.6|-7.5|||ANCOVA|Model terms: treatment, baseline Apo B:Apo A-I, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-7.5|-11.6|<0.001
70989451|NCT00418834|141487422|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-7.7|-2.9|||ANCOVA|Model terms: treatment, baseline Apo B:Apo A-I, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||-2.9|-7.7|<0.001
70989452|NCT00418834|141487423|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.9|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-15.3|-10.5|||ANCOVA|Model terms: treatment, baseline non-HDL-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-10.5|-15.3|<0.001
70989453|NCT00418834|141487424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|1.6|<|0.001||95.0|-9.8|-3.6|||ANCOVA|Model terms: treatment, baseline non-HDL-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||-3.6|-9.8|<0.001
70989454|NCT00418834|141487425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.8||||0.534||95.0|-11.9|6.4|||Longitudinal Data Analysis (LDA)|LDA method of Liang and Zeger with model terms: treatment, time, AVD status, and the interaction of time by treatment|"(Atorva 10 mg + EZ minus Atorva 20 mg)~Data for analysis was transformed by the natural log and the difference in geometric mean % change from BL calculated based on the difference in the back-transformed least squares means."|||6.4|-11.9|0.534
70989455|NCT00418834|141487426|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0||||0.09||95.0|-15.6|1.6|||Longitudinal Data Analysis (LDA)|LDA method of Liang and Zeger with model terms: treatment, time, AVD status, and the interaction of time by treatment|"(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)~Data for analysis was transformed by the natural log and the difference in geometric mean % change from BL calculated based on the difference in the back-transformed least squares means."|||1.6|-15.6|0.090
70989456|NCT01953328|141487427|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-73.97|STANDARD_ERROR_OF_MEAN|2.3|<|0.001|TWO_SIDED|95.0|-78.54|-69.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-69.41|-78.54|<0.001
70989457|NCT01953328|141487427|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-72.89|STANDARD_ERROR_OF_MEAN|2.18|<|0.001|TWO_SIDED|95.0|-77.22|-68.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-68.57|-77.22|<0.001
70989458|NCT01953328|141487427|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-74.41|STANDARD_ERROR_OF_MEAN|3.43|<|0.001|TWO_SIDED|95.0|-81.21|-67.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-67.61|-81.21|<0.001
70989459|NCT01953328|141487427|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-74.27|STANDARD_ERROR_OF_MEAN|2.35|<|0.001|TWO_SIDED|95.0|-78.93|-69.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-69.60|-78.93|<0.001
70989460|NCT01953328|141487428|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-74.85|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED|95.0|-80.22|-69.47||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-69.47|-80.22|<0.001
70989461|NCT01953328|141487428|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-69.91|STANDARD_ERROR_OF_MEAN|2.36|<|0.001|TWO_SIDED|95.0|-74.6|-65.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-65.23|-74.60|<0.001
70989462|NCT01953328|141487428|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-78.85|STANDARD_ERROR_OF_MEAN|3.88|<|0.001|TWO_SIDED|95.0|-83.55|-68.15||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-68.15|-83.55|<0.001
71038803|NCT00577655|141584986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|42.578||||0.2375|TWO_SIDED|95.0|-28.541|113.7||significance level of 0.05.|ANCOVA|terms for treatment and center, baseline as a covariate|Active - Placebo|Day 1 Baseline||113.70|-28.541|0.2375
71038804|NCT00577655|141584987|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.524||||0.0017|TWO_SIDED|95.0|2.524|10.523||significance level of 0.05.|ANOVA|terms for treatment, center, time, time x treatment, subject as a random|Active - Placebo|Day 1||10.523|2.524|0.0017
71038805|NCT00577655|141584987|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.998||||0.0521|TWO_SIDED|95.0|-0.037|8.032||significance level of 0.05.|ANOVA|terms for treatment, center, time, time x treatment, subject as a random|Active - Placebo|Day 22||8.032|-0.037|0.0521
70989463|NCT01953328|141487428|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-66.87|STANDARD_ERROR_OF_MEAN|3.03|<|0.001|TWO_SIDED|95.0|-72.88|-60.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-60.87|-72.88|<0.001
70989464|NCT01953328|141487429|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-89.3|STANDARD_ERROR_OF_MEAN|4.6|<|0.001|TWO_SIDED|95.0|-98.4|-80.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-80.2|-98.4|<0.001
70989465|NCT01953328|141487429|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-86.3|STANDARD_ERROR_OF_MEAN|4.4|<|0.001|TWO_SIDED|95.0|-95.1|-77.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-77.5|-95.1|<0.001
70989466|NCT01953328|141487429|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.7|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-75.3|-62.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-62.1|-75.3|<0.001
70989467|NCT01953328|141487429|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-72.0|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-79.5|-64.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-64.6|-79.5|<0.001
70989468|NCT01953328|141487430|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-90.8|STANDARD_ERROR_OF_MEAN|5.1|<|0.001|TWO_SIDED|95.0|-100.9|-80.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-80.7|-100.9|<0.001
70989469|NCT01953328|141487430|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-83.6|STANDARD_ERROR_OF_MEAN|4.5|<|0.001|TWO_SIDED|95.0|-92.5|-74.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-74.8|-92.5|<0.001
70989470|NCT01953328|141487430|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-69.6|STANDARD_ERROR_OF_MEAN|3.5|<|0.001|TWO_SIDED|95.0|-76.5|-62.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-62.6|-76.5|<0.001
70989471|NCT01953328|141487430|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-65.5|STANDARD_ERROR_OF_MEAN|4.2|<|0.001|TWO_SIDED|95.0|-73.8|-57.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-57.1|-73.8|<0.001
70989472|NCT01953328|141487431|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.67|STANDARD_ERROR_OF_MEAN|2.21|<|0.001|TWO_SIDED|95.0|-73.06|-64.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-64.27|-73.06|<0.001
71038806|NCT00577655|141584988|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.477||||0.0647|TWO_SIDED|95.0|0.98|2.23||significance level of 0.05.|Regression, Cox||Active/Placebo|Day 1||2.23|0.98|0.0647
71038807|NCT00577655|141584988|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|2.088||||0.0005|TWO_SIDED|95.0|1.38|3.15||significance level of 0.05.|Regression, Cox||Active/Placebo|Day 22||3.15|1.38|0.0005
71038808|NCT00577655|141584989|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.141||||0.5059|TWO_SIDED|95.0|0.77|1.69||significance level of 0.05.|Regression, Cox||Active/Placebo|Day 1||1.69|0.77|0.5059
71038809|NCT00577655|141584989|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.533||||0.0333|TWO_SIDED|95.0|1.03|2.27||significance level of 0.05.|Regression, Cox||Active/Placebo|Day 22||2.27|1.03|0.0333
71038810|NCT00577655|141584990|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3888||||||significance level of 0.05.|Fisher Exact|||Day 1||||0.3888
71038811|NCT00577655|141584990|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1249||||||significance level of 0.05.|Fisher Exact|||Day 22||||0.1249
71038812|NCT00577655|141584991|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0343||||||significance level of 0.05.|Fisher Exact|||Day 1||||0.0343
71038813|NCT00577655|141584991|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0962||||||significance level of 0.05.|Fisher Exact|||Day 22||||0.0962
71038814|NCT00577655|141584992|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0109||||||significance level of 0.05.|Fisher Exact|||Day 1||||0.0109
71038815|NCT00577655|141584992|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0845||||||significance level of 0.05.|Fisher Exact|||Day 22||||0.0845
71038816|NCT00577655|141584993|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0013||||||significance level of 0.05.|Fisher Exact|||Day 1||||0.0013
71038817|NCT00577655|141584993|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0085||||||significance level of 0.05.|Fisher Exact|||Day 22||||0.0085
70989473|NCT01953328|141487431|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-65.95|STANDARD_ERROR_OF_MEAN|1.91|<|0.001|TWO_SIDED|95.0|-69.74|-62.16||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-62.16|-69.74|<0.001
70989474|NCT01953328|141487431|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.14|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-73.3|-62.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-62.99|-73.30|<0.001
70989475|NCT01953328|141487431|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-67.28|STANDARD_ERROR_OF_MEAN|1.94|<|0.001|TWO_SIDED|95.0|-71.14|-63.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-63.42|-71.14|<0.001
71098649|NCT03537729|141705806|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.12||0.23|TWO_SIDED|95.0|-0.09|0.38||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Cues minus control|The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.||0.38|-0.09|.23
70989476|NCT01953328|141487432|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.93|STANDARD_ERROR_OF_MEAN|2.54|<|0.001|TWO_SIDED|95.0|-73.96|-63.89||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-63.89|-73.96|<0.001
70989477|NCT01953328|141487432|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-63.58|STANDARD_ERROR_OF_MEAN|2.2|<|0.001|TWO_SIDED|95.0|-67.96|-59.21||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-59.21|-67.96|<0.001
71038818|NCT00577655|141584994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.072||||0.4674|TWO_SIDED|95.0|-0.265|0.122||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as a covariate, subject as random.|Active - Placebo|Week 1||0.122|-0.265|0.4674
71038819|NCT00577655|141584994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.171||||0.084|TWO_SIDED|95.0|-0.365|0.023||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as covariate, subject as random|Active - Placebo|Week 2||0.023|-0.365|0.0840
71038820|NCT00577655|141584994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.138||||0.1699|TWO_SIDED|95.0|-0.335|0.059||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as covariate, subject as random|Active - Placebo|Week 3||0.059|-0.335|0.1699
71038821|NCT00577655|141584996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.926||||0.1391|TWO_SIDED|95.0|-3.256|23.108||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as a covariate, subject as random.|Active - Placebo|Week 1||23.108|-3.256|0.1391
71038822|NCT00577655|141584996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.923||||0.1043|TWO_SIDED|95.0|-2.278|24.124||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as a covariate, subject as random.|Active - Placebo|Week 2||24.124|-2.278|0.1043
71038823|NCT00577655|141584996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.546||||0.157|TWO_SIDED|95.0|-3.705|22.798||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as a covariate, subject as random.|Active - Placebo|Week 3||22.798|-3.705|0.1570
71038824|NCT00577655|141584997|SUPERIORITY_OR_OTHER_LEGACY||ratio of Active to Placebo|0.989||||0.9846|TWO_SIDED|95.0|-0.121|2.099||significance level of 0.05.|mixed poisson regression model|||"Week 1~P-value, mean and confidence interval calculated from a 0 inflated mixed poisson regression model with fixed effect terms for treatment, week, treatment by week interaction, baseline as a covariate and a random term for subject. The null hypothesis is that the ratio equals 1. Estimated means are conditional upon the random effect, assume a random effect of 0 and a covariate value at the average."||2.099|-0.121|0.9846
71038825|NCT00577655|141584997|SUPERIORITY_OR_OTHER_LEGACY||ratio of Active to Placebo|0.961||||0.9447|TWO_SIDED|95.0|-0.116|2.039||significance level of 0.05.|mixed poisson regression model|||"Week 2~P-value, mean and confidence interval calculated from a 0 inflated mixed poisson regression model with fixed effect terms for treatment, week, treatment by week interaction, baseline as a covariate and a random term for subject. The null hypothesis is that the ratio equals 1. Estimated means are conditional upon the random effect, assume a random effect of 0 and a covariate value at the average."||2.039|-0.116|0.9447
70989478|NCT01953328|141487432|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.82|STANDARD_ERROR_OF_MEAN|3.01|<|0.001|TWO_SIDED|95.0|-74.79|-62.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-62.86|-74.79|<0.001
70989479|NCT01953328|141487432|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.89|STANDARD_ERROR_OF_MEAN|2.47|<|0.001|TWO_SIDED|95.0|-65.78|-55.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-55.99|-65.78|<0.001
70989480|NCT01953328|141487433|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-64.44|STANDARD_ERROR_OF_MEAN|2.04|<|0.001|TWO_SIDED|95.0|-68.49|-60.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-60.39|-68.49|<0.001
70989481|NCT01953328|141487433|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-59.24|STANDARD_ERROR_OF_MEAN|2.05|<|0.001|TWO_SIDED|95.0|-63.3|-55.17||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-55.17|-63.30|<0.001
70989482|NCT01953328|141487433|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.06|STANDARD_ERROR_OF_MEAN|2.42|<|0.001|TWO_SIDED|95.0|-64.87|-55.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-55.25|-64.87|<0.001
70989483|NCT01953328|141487433|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-63.39|STANDARD_ERROR_OF_MEAN|1.9|<|0.001|TWO_SIDED|95.0|-67.15|-59.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-59.62|-67.15|<0.001
70989484|NCT01953328|141487434|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-65.56|STANDARD_ERROR_OF_MEAN|2.4|<|0.001|TWO_SIDED|95.0|-70.34|-60.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-60.79|-70.34|<0.001
71098650|NCT03537729|141705806|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.12||0.9|TWO_SIDED|95.0|-0.25|0.22||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus control|The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.||0.22|-0.25|.90
70989485|NCT01953328|141487434|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-57.23|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-62.05|-52.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-52.40|-62.05|<0.001
70989486|NCT01953328|141487434|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.37|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-65.91|-54.83||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-54.83|-65.91|<0.001
70989487|NCT01953328|141487434|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-56.15|STANDARD_ERROR_OF_MEAN|2.4|<|0.001|TWO_SIDED|95.0|-60.92|-51.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-51.39|-60.92|<0.001
70989488|NCT01953328|141487435|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-45.54|STANDARD_ERROR_OF_MEAN|1.92|<|0.001|TWO_SIDED|95.0|-49.35|-41.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-41.73|-49.35|<0.001
70989489|NCT01953328|141487435|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-43.43|STANDARD_ERROR_OF_MEAN|1.69|<|0.001|TWO_SIDED|95.0|-46.78|-40.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-40.08|-46.78|<0.001
70989490|NCT01953328|141487435|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-40.98|STANDARD_ERROR_OF_MEAN|1.96|<|0.001|TWO_SIDED|95.0|-44.88|-37.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-37.08|-44.88|<0.001
70989491|NCT01953328|141487435|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-43.14|STANDARD_ERROR_OF_MEAN|1.68|<|0.001|TWO_SIDED|95.0|-46.48|-39.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-39.80|-46.48|<0.001
70989492|NCT01953328|141487436|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-45.44|STANDARD_ERROR_OF_MEAN|2.21|<|0.001|TWO_SIDED|95.0|-49.83|-41.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-41.05|-49.83|<0.001
70989493|NCT01953328|141487436|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-41.34|STANDARD_ERROR_OF_MEAN|1.76|<|0.001|TWO_SIDED|95.0|-44.84|-37.85||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-37.85|-44.84|<0.001
70989494|NCT01953328|141487436|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-40.96|STANDARD_ERROR_OF_MEAN|2.21|<|0.001|TWO_SIDED|95.0|-45.35|-36.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-36.57|-45.35|<0.001
70989495|NCT01953328|141487436|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-38.44|STANDARD_ERROR_OF_MEAN|1.93|<|0.001|TWO_SIDED|95.0|-42.26|-34.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-34.62|-42.26|<0.001
70989496|NCT01953328|141487437|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-54.77|STANDARD_ERROR_OF_MEAN|2.32|<|0.001|TWO_SIDED|95.0|-59.37|-50.17||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-50.17|-59.37|<0.001
70989497|NCT01953328|141487437|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-52.66|STANDARD_ERROR_OF_MEAN|2.17|<|0.001|TWO_SIDED|95.0|-56.95|-48.36||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-48.36|-56.95|<0.001
70989498|NCT01953328|141487437|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-50.83|STANDARD_ERROR_OF_MEAN|1.96|<|0.001|TWO_SIDED|95.0|-54.72|-46.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-46.93|-54.72|<0.001
70989499|NCT01953328|141487437|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.69|STANDARD_ERROR_OF_MEAN|2.04|<|0.001|TWO_SIDED|95.0|-53.74|-45.64||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-45.64|-53.74|<0.001
70989500|NCT01953328|141487438|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-55.45|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-60.93|-49.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-49.98|-60.93|<0.001
70989501|NCT01953328|141487438|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-50.95|STANDARD_ERROR_OF_MEAN|2.5|<|0.001|TWO_SIDED|95.0|-55.91|-46.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-46.00|-55.91|<0.001
70989502|NCT01953328|141487438|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-51.36|STANDARD_ERROR_OF_MEAN|2.3|<|0.001|TWO_SIDED|95.0|-55.93|-46.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-46.80|-55.93|<0.001
70989503|NCT01953328|141487438|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-45.44|STANDARD_ERROR_OF_MEAN|2.33|<|0.001|TWO_SIDED|95.0|-50.08|-40.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-40.81|-50.08|<0.001
70989504|NCT01953328|141487439|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-66.47|STANDARD_ERROR_OF_MEAN|2.07|<|0.001|TWO_SIDED|95.0|-70.58|-62.36||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-62.36|-70.58|<0.001
70989505|NCT01953328|141487439|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-64.33|STANDARD_ERROR_OF_MEAN|2.35|<|0.001|TWO_SIDED|95.0|-69.01|-59.66||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-59.66|-69.01|<0.001
70989506|NCT01953328|141487439|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-64.05|STANDARD_ERROR_OF_MEAN|2.44|<|0.001|TWO_SIDED|95.0|-68.9|-59.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-59.20|-68.90|<0.001
71098651|NCT03537729|141705806|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.11||0.17|TWO_SIDED|95.0|-0.38|0.07||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus cues only.|The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.||0.07|-0.38|.17
70989507|NCT01953328|141487439|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-67.26|STANDARD_ERROR_OF_MEAN|2.07|<|0.001|TWO_SIDED|95.0|-71.36|-63.15||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-63.15|-71.36|<0.001
70989508|NCT01953328|141487440|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.29|STANDARD_ERROR_OF_MEAN|2.24|<|0.001|TWO_SIDED|95.0|-72.75|-63.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-63.84|-72.75|<0.001
70989509|NCT01953328|141487440|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-62.53|STANDARD_ERROR_OF_MEAN|2.81|<|0.001|TWO_SIDED|95.0|-68.11|-56.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-56.94|-68.11|<0.001
70989510|NCT01953328|141487440|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-63.97|STANDARD_ERROR_OF_MEAN|2.75|<|0.001|TWO_SIDED|95.0|-69.44|-58.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-58.50|-69.44|<0.001
70989511|NCT01953328|141487440|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.62|STANDARD_ERROR_OF_MEAN|2.47|<|0.001|TWO_SIDED|95.0|-65.51|-55.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-55.72|-65.51|<0.001
70989512|NCT01953328|141487441|SUPERIORITY_OR_OTHER||Treatment Difference|98.0|||<|0.001|TWO_SIDED|95.0|86.8|99.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||99.6|86.8|<0.001
70989513|NCT01953328|141487441|SUPERIORITY_OR_OTHER||Treatment Difference|96.0|||<|0.001|TWO_SIDED|95.0|84.1|98.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||98.9|84.1|<0.001
70989514|NCT01953328|141487441|SUPERIORITY_OR_OTHER||Treatment Difference|73.6|||<|0.001|TWO_SIDED|95.0|57.1|83.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||83.4|57.1|<0.001
70989515|NCT01953328|141487441|SUPERIORITY_OR_OTHER||Treatment Difference|82.4|||<|0.001|TWO_SIDED|95.0|67.5|90.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||90.0|67.5|<0.001
70989516|NCT01953328|141487442|SUPERIORITY_OR_OTHER||Treatment Difference|98.0|||<|0.001|TWO_SIDED|95.0|86.7|99.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||99.6|86.7|<0.001
70989517|NCT01953328|141487442|SUPERIORITY_OR_OTHER||Treatment Difference|91.8|||<|0.001|TWO_SIDED|95.0|78.2|96.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||96.0|78.2|<0.001
70989518|NCT01953328|141487442|SUPERIORITY_OR_OTHER||Treatment Difference|75.6|||<|0.001|TWO_SIDED|95.0|59.3|85.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||85.0|59.3|<0.001
70989519|NCT01953328|141487442|SUPERIORITY_OR_OTHER||Treatment Difference|78.0|||<|0.001|TWO_SIDED|95.0|62.6|86.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||86.9|62.6|<0.001
70989520|NCT01953328|141487443|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-51.2|STANDARD_ERROR_OF_MEAN|6.39|<|0.001|TWO_SIDED|95.0|-63.88|-38.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-38.52|-63.88|<0.001
70989521|NCT01953328|141487443|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.08|STANDARD_ERROR_OF_MEAN|4.94|<|0.001|TWO_SIDED|95.0|-58.89|-39.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-39.27|-58.89|<0.001
70989522|NCT01953328|141487443|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.55|STANDARD_ERROR_OF_MEAN|5.14|<|0.001|TWO_SIDED|95.0|-59.74|-39.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-39.35|-59.74|<0.001
70989523|NCT01953328|141487443|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-43.93|STANDARD_ERROR_OF_MEAN|4.95|<|0.001|TWO_SIDED|95.0|-53.75|-34.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-34.12|-53.75|<0.001
70989524|NCT01953328|141487444|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-50.07|STANDARD_ERROR_OF_MEAN|7.64|<|0.001|TWO_SIDED|95.0|-65.25|-34.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-34.90|-65.25|<0.001
70989525|NCT01953328|141487444|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-48.77|STANDARD_ERROR_OF_MEAN|5.9|<|0.001|TWO_SIDED|95.0|-60.49|-37.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-37.05|-60.49|<0.001
70989526|NCT01953328|141487444|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-52.68|STANDARD_ERROR_OF_MEAN|5.73|<|0.001|TWO_SIDED|95.0|-64.06|-41.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-41.30|-64.06|<0.001
70989527|NCT01953328|141487444|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-39.97|STANDARD_ERROR_OF_MEAN|5.29|<|0.001|TWO_SIDED|95.0|-50.46|-29.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-29.48|-50.46|<0.001
70989528|NCT01953328|141487445|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-27.93|STANDARD_ERROR_OF_MEAN|6.72|<|0.001|TWO_SIDED|95.0|-41.27|-14.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-14.59|-41.27|<0.001
70989529|NCT01953328|141487445|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-21.94|STANDARD_ERROR_OF_MEAN|5.34|<|0.001|TWO_SIDED|95.0|-32.54|-11.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-11.35|-32.54|<0.001
70989530|NCT01953328|141487445|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-20.01|STANDARD_ERROR_OF_MEAN|4.83|<|0.001|TWO_SIDED|95.0|-29.59|-10.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-10.43|-29.59|<0.001
70989531|NCT01953328|141487445|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-20.72|STANDARD_ERROR_OF_MEAN|6.78||0.01|TWO_SIDED|95.0|-34.18|-7.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-7.26|-34.18|0.010
70989532|NCT01953328|141487446|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-27.57|STANDARD_ERROR_OF_MEAN|9.45|<|0.001|TWO_SIDED|95.0|-46.33|-8.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-8.81|-46.33|<0.001
70989533|NCT01953328|141487446|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-19.97|STANDARD_ERROR_OF_MEAN|5.9|<|0.001|TWO_SIDED|95.0|-31.68|-8.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-8.25|-31.68|<0.001
70989534|NCT01953328|141487446|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-17.17|STANDARD_ERROR_OF_MEAN|5.53|<|0.001|TWO_SIDED|95.0|-28.15|-6.19||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-6.19|-28.15|<0.001
70989535|NCT01953328|141487446|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-16.92|STANDARD_ERROR_OF_MEAN|7.24||0.01|TWO_SIDED|95.0|-31.29|-2.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-2.56|-31.29|0.010
70989536|NCT01953328|141487447|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|12.33|STANDARD_ERROR_OF_MEAN|2.49|<|0.001|TWO_SIDED|95.0|7.39|17.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||17.27|7.39|<0.001
70989537|NCT01953328|141487447|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|14.61|STANDARD_ERROR_OF_MEAN|2.36|<|0.001|TWO_SIDED|95.0|9.93|19.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||19.30|9.93|<0.001
70989538|NCT01953328|141487447|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|15.36|STANDARD_ERROR_OF_MEAN|2.64|<|0.001|TWO_SIDED|95.0|10.12|20.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||20.60|10.12|<0.001
70989539|NCT01953328|141487447|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|9.15|STANDARD_ERROR_OF_MEAN|2.26||0.001|TWO_SIDED|95.0|4.67|13.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||13.62|4.67|0.001
70989540|NCT01953328|141487448|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|13.46|STANDARD_ERROR_OF_MEAN|3.06|<|0.001|TWO_SIDED|95.0|7.4|19.53||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||19.53|7.40|<0.001
70989541|NCT01953328|141487448|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|15.2|STANDARD_ERROR_OF_MEAN|2.68|<|0.001|TWO_SIDED|95.0|9.87|20.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||20.52|9.87|<0.001
70989542|NCT01953328|141487448|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|16.85|STANDARD_ERROR_OF_MEAN|3.08|<|0.001|TWO_SIDED|95.0|10.74|22.95||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||22.95|10.74|<0.001
70989543|NCT01953328|141487448|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|10.2|STANDARD_ERROR_OF_MEAN|2.7||0.001|TWO_SIDED|95.0|4.85|15.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||15.55|4.85|0.001
70989544|NCT01953328|141487449|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-27.85|STANDARD_ERROR_OF_MEAN|5.8|<|0.001|TWO_SIDED|95.0|-39.37|-16.34||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-16.34|-39.37|<0.001
70989545|NCT01953328|141487449|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-22.65|STANDARD_ERROR_OF_MEAN|5.17|<|0.001|TWO_SIDED|95.0|-32.91|-12.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-12.39|-32.91|<0.001
70989546|NCT01953328|141487449|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-18.09|STANDARD_ERROR_OF_MEAN|4.69||0.001|TWO_SIDED|95.0|-27.4|-8.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-8.77|-27.40|0.001
70989547|NCT01953328|141487449|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-27.16|STANDARD_ERROR_OF_MEAN|6.12|<|0.001|TWO_SIDED|95.0|-39.31|-15.01||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-15.01|-39.31|<0.001
70989548|NCT01953328|141487450|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-28.42|STANDARD_ERROR_OF_MEAN|7.08|<|0.001|TWO_SIDED|95.0|-42.48|-14.36||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-14.36|-42.48|<0.001
70989549|NCT01953328|141487450|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-20.81|STANDARD_ERROR_OF_MEAN|5.78|<|0.001|TWO_SIDED|95.0|-32.29|-9.33||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-9.33|-32.29|<0.001
70989550|NCT01953328|141487450|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-15.05|STANDARD_ERROR_OF_MEAN|5.37||0.001|TWO_SIDED|95.0|-25.72|-4.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-4.39|-25.72|0.001
70989551|NCT01953328|141487450|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-24.35|STANDARD_ERROR_OF_MEAN|6.22|<|0.001|TWO_SIDED|95.0|-36.7|-11.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-11.99|-36.70|<0.001
70989552|NCT04710862|141487454|SUPERIORITY||||||<|0.0005|||||||Mixed Models Analysis|||||||<0.0005
70989553|NCT04710862|141487455|SUPERIORITY||||||<|0.0005|||||||Mixed Models Analysis|||||||<0.0005
70989554|NCT04710862|141487456|SUPERIORITY|||||||0.012|||||||Mixed Models Analysis|||||||0.012
70989555|NCT04710862|141487457|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
70989556|NCT04710862|141487458|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||||||0.004
70989557|NCT04710862|141487459|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
70989558|NCT04710862|141487460|SUPERIORITY|||||||0.328|||||||Mixed Models Analysis|||||||0.328
70989559|NCT02364947|141487461|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-4.34|STANDARD_ERROR_OF_MEAN|0.87||0.0001|TWO_SIDED|95.0|-6.05|-2.62||Efficacy of the doses (change from baseline in the number of HDDs vs placebo) was assessed using a closed testing procedure. The 20 mg dose was tested at a 5% level of significance and only if significant, the testing would proceed to the 10 mg dose.|Mixed Models Analysis|||||-2.62|-6.05|0.0001
70989560|NCT02364947|141487461|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-4.18|STANDARD_ERROR_OF_MEAN|0.95||0.0001|TWO_SIDED|95.0|-6.05|-2.32||Efficacy of the doses (change from baseline in the number of HDDs vs placebo) was assessed using a closed testing procedure. The 20 mg dose was tested at a 5% level of significance and only if significant, the testing would proceed to the 10 mg dose.|Mixed Models Analysis|||||-2.32|-6.05|0.0001
70989561|NCT02364947|141487462|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-3.92|STANDARD_ERROR_OF_MEAN|0.9|<|0.0001|TWO_SIDED|95.0|-5.69|-2.16|||Mixed Models Analysis|||||-2.16|-5.69|<0.0001
70989562|NCT02364947|141487462|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-4.54|STANDARD_ERROR_OF_MEAN|0.98|<|0.0001|TWO_SIDED|95.0|-6.46|-2.63|||Mixed Models Analysis|||||-2.63|-6.46|<0.0001
70989563|NCT02364947|141487463|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-12.47|STANDARD_ERROR_OF_MEAN|2.72|<|0.0001|TWO_SIDED|95.0|-17.81|-7.13|||Mixed Models Analysis|||Change in total alcohol consumption (TAC) from baseline at Week 12||-7.13|-17.81|<0.0001
70989564|NCT02364947|141487463|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-12.94|STANDARD_ERROR_OF_MEAN|2.95|<|0.0001|TWO_SIDED|95.0|-18.72|-7.15|||Mixed Models Analysis|||||-7.15|-18.72|<0.0001
70989565|NCT02364947|141487464|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-11.15|STANDARD_ERROR_OF_MEAN|2.86||0.0001|TWO_SIDED|95.0|-16.77|-5.53|||Mixed Models Analysis|||||-5.53|-16.77|0.0001
70989566|NCT02364947|141487464|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-11.27|STANDARD_ERROR_OF_MEAN|3.11||0.0003|TWO_SIDED|95.0|-17.37|-5.17|||Mixed Models Analysis|||||-5.17|-17.37|0.0003
70989567|NCT02364947|141487465|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|22.0|||<|0.0001|TWO_SIDED|95.0|13.6|30.4|||Cochran-Mantel-Haenszel|||||30.4|13.6|<0.0001
70989568|NCT02364947|141487465|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|15.7||||0.0007|TWO_SIDED|95.0|6.5|25.0|||Cochran-Mantel-Haenszel|||||25.0|6.5|0.0007
70989569|NCT02364947|141487466|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|18.0||||0.0002|TWO_SIDED|95.0|8.8|27.2|||Cochran-Mantel-Haenszel|||||27.2|8.8|0.0002
70989570|NCT02364947|141487466|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|20.6||||0.0001|TWO_SIDED|95.0|10.4|30.8|||Cochran-Mantel-Haenszel|||||30.8|10.4|0.0001
70989571|NCT02364947|141487467|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|17.8|||<|0.0001|TWO_SIDED|95.0|10.5|25.1|||Cochran-Mantel-Haenszel|||||25.1|10.5|<0.0001
70989572|NCT02364947|141487467|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|14.3||||0.0002|TWO_SIDED|95.0|6.4|22.2|||Cochran-Mantel-Haenszel|||||22.2|6.4|0.0002
70989573|NCT02364947|141487468|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|11.0||||0.0079|TWO_SIDED|95.0|2.9|19.1|||Cochran-Mantel-Haenszel|||||19.1|2.9|0.0079
70989574|NCT02364947|141487468|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|14.8||||0.001|TWO_SIDED|95.0|5.8|23.9|||Cochran-Mantel-Haenszel|||||23.9|5.8|0.0010
70989575|NCT02364947|141487469|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|9.9||||0.0022|TWO_SIDED|95.0|3.5|16.3|||Cochran-Mantel-Haenszel|||||16.3|3.5|0.0022
70989576|NCT02364947|141487469|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|11.1||||0.0016|TWO_SIDED|95.0|3.8|18.3|||Cochran-Mantel-Haenszel|||||18.3|3.8|0.0016
70989577|NCT02364947|141487470|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|13.6||||0.0003|TWO_SIDED|95.0|6.2|20.9|||Cochran-Mantel-Haenszel|||||20.9|6.2|0.0003
70989578|NCT02364947|141487470|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|12.8||||0.0013|TWO_SIDED|95.0|4.6|21.0|||Cochran-Mantel-Haenszel|||||21.0|4.6|0.0013
70989579|NCT02364947|141487471|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|15.2||||0.0002|TWO_SIDED|95.0|7.1|23.3|||Cochran-Mantel-Haenszel|||||23.3|7.1|0.0002
71098652|NCT03537729|141705806|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.11||0.58|TWO_SIDED|95.0|-0.16|0.28||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Cues minus control.|The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.||0.28|-0.16|.58
70989580|NCT02364947|141487471|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|17.9||||0.0001|TWO_SIDED|95.0|8.9|26.9|||Cochran-Mantel-Haenszel|||||26.9|8.9|0.0001
70989581|NCT02364947|141487472|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|8.0||||0.0724|TWO_SIDED|95.0|-0.7|16.7|||Cochran-Mantel-Haenszel|||||16.7|-0.7|0.0724
70989582|NCT02364947|141487472|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|19.6||||0.0001|TWO_SIDED|95.0|9.9|29.2|||Cochran-Mantel-Haenszel|||||29.2|9.9|0.0001
70989583|NCT02364947|141487473|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.07||0.0002|TWO_SIDED|95.0|-0.4|-0.13|||Mixed Models Analysis|||||-0.13|-0.40|0.0002
70989584|NCT02364947|141487473|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.08||0.0001|TWO_SIDED|95.0|-0.45|-0.15|||Mixed Models Analysis|||||-0.15|-0.45|0.0001
70989585|NCT02364947|141487474|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.48|-0.18|||Mixed Models Analysis|||||-0.18|-0.48|<0.0001
70989586|NCT02364947|141487474|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.51|-0.19|||Mixed Models Analysis|||||-0.19|-0.51|<0.0001
70989587|NCT02364947|141487475|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used. Baseline CGI-S value was used as baseline value in MMRM.|Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.69|-0.33|||Mixed Models Analysis|||||-0.33|-0.69|<0.0001
70989588|NCT02364947|141487475|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used. Baseline CGI-S value was used as baseline value in MMRM.|Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.67|-0.27|||Mixed Models Analysis|||||-0.27|-0.67|<0.0001
70989589|NCT02364947|141487476|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used. Baseline CGI-S value was used as baseline value in MMRM.|Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.7|-0.31|||Mixed Models Analysis|||||-0.31|-0.70|<0.0001
71098653|NCT03537729|141705806|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.11||0.15|TWO_SIDED|95.0|-0.06|0.37||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus control.|The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.||0.37|-0.06|.15
71098654|NCT03537729|141705806|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.1||0.37|TWO_SIDED|95.0|-0.11|0.29||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus cues only.|The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.||0.29|-0.11|.37
70989590|NCT02364947|141487476|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used. Baseline CGI-S value was used as baseline value in MMRM.|Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.77|-0.33|||Mixed Models Analysis|||||-0.33|-0.77|<0.0001
70989591|NCT02364947|141487477|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.192|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001|TWO_SIDED|95.0|-0.262|-0.121|||Mixed Models Analysis|||||-0.121|-0.262|<0.0001
70989592|NCT02364947|141487477|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.156|STANDARD_ERROR_OF_MEAN|0.039||0.0001|TWO_SIDED|95.0|-0.232|-0.08|||Mixed Models Analysis|||||-0.080|-0.232|0.0001
70989593|NCT02364947|141487478|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.168|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|-0.248|-0.088|||Mixed Models Analysis|||||-0.088|-0.248|<0.0001
70989594|NCT02364947|141487478|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.139|STANDARD_ERROR_OF_MEAN|0.044||0.0017|TWO_SIDED|95.0|-0.226|-0.052|||Mixed Models Analysis|||||-0.052|-0.226|0.0017
70989595|NCT02364947|141487479|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.031||0.0234|TWO_SIDED|95.0|-0.13|-0.009|||Mixed Models Analysis|||||-0.009|-0.130|0.0234
70989596|NCT02364947|141487479|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.049|STANDARD_ERROR_OF_MEAN|0.033||0.1374|TWO_SIDED|95.0|-0.115|0.016|||Mixed Models Analysis|||Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.||0.016|-0.115|0.1374
70989597|NCT02364947|141487480|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.066|STANDARD_ERROR_OF_MEAN|0.031||0.0348|TWO_SIDED|95.0|-0.127|-0.005|||Mixed Models Analysis|||||-0.005|-0.127|0.0348
70989598|NCT02364947|141487480|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.049|STANDARD_ERROR_OF_MEAN|0.034||0.1444|TWO_SIDED|95.0|-0.116|0.017|||Mixed Models Analysis|||||0.017|-0.116|0.1444
70989599|NCT04009096|141487483|OTHER|||||||0.14||||||Two tailed p value reported for Mann-Whitney test comparing controls with each vaccinees|Wilcoxon (Mann-Whitney)|||Comparison of pooled data from Groups 1, 2 and 3 volunteers who completed CHMI with pooled data of infectivity controls (unvaccinated) from CHMI study running in parallel (VAC069 study)||||0.14
70989600|NCT05151471|141487488|SUPERIORITY|||||||0.78|||||||Log Rank|||||||0.78
70989601|NCT05151471|141487489|SUPERIORITY|||||||0.704|||||||ANCOVA|||Week 72||||0.704
70989602|NCT05151471|141487489|SUPERIORITY|||||||0.131|||||||ANCOVA|||Week 96||||0.131
70989603|NCT05151471|141487490|SUPERIORITY|||||||0.954|||||||Mixed Model for Repeated Measures (MMRM)|||Week 72||||0.954
70989604|NCT05151471|141487490|SUPERIORITY|||||||0.591|||||||Mixed Model for Repeated Measures (MMRM)|||Week 96||||0.591
70989605|NCT05151471|141487491|SUPERIORITY|||||||0.513|||||||Mixed Model for Repeated Measures (MMRM)|||Week 72||||0.513
70989606|NCT05151471|141487491|SUPERIORITY|||||||0.344|||||||Mixed Model for Repeated Measures (MMRM)|||Week 84||||0.344
70989607|NCT05151471|141487491|SUPERIORITY|||||||0.142|||||||Mixed Model for Repeated Measures (MMRM)|||Week 96||||0.142
70989608|NCT03161938|141487495|SUPERIORITY||Odds Ratio (OR)|0.508||||0.248|TWO_SIDED|95.0|0.159|1.62|||Chi-squared, Corrected|||Null hypothesis: Patients receiving 48 mg of preoperative dexamethasone have less postoperative pain. Power calculation: Acute pain is reduced from 70% to 35% for patients receiving 48 mg of dexamathesone, 80% power, 0.05 statistical significance level.||1.620|0.159|0.248
70989609|NCT03161938|141487496|SUPERIORITY|||||||0.519|||||||Wilcoxon (Mann-Whitney)|||||||0.519
70989610|NCT03161938|141487497|SUPERIORITY|||||||0.468|||||||Wilcoxon (Mann-Whitney)|||||||0.468
70989611|NCT03161938|141487498|SUPERIORITY|||||||0.913|||||||Wilcoxon (Mann-Whitney)|||Maximal pain||||0.913
70989612|NCT03161938|141487498|SUPERIORITY|||||||0.722|||||||Wilcoxon (Mann-Whitney)|||Average pain||||0.722
70989613|NCT03161938|141487499|SUPERIORITY||Odds Ratio (OR)|1.19||||0.768|TWO_SIDED|95.0|0.374|3.793|||Chi-squared, Corrected|||||3.793|0.374|0.768
70989614|NCT03161938|141487500|SUPERIORITY|||||||0.133|||||||Regression, Linear|||||||0.133
70989615|NCT03161938|141487501|SUPERIORITY|||||||0.768||||||Not adjusted for multiple comparisons, statistical level of significance 0.01 (bonferroni correction)|Chi-squared, Corrected|||Day 0||||0.768
70989616|NCT03161938|141487501|SUPERIORITY|||||||0.376|||||||Chi-squared, Corrected|||Day 1||||0.376
71038826|NCT00577655|141584997|SUPERIORITY_OR_OTHER_LEGACY||ratio of Active to Placebo|0.887||||0.8326|TWO_SIDED|95.0|-0.111|1.885||significance level of 0.05.|mixed poisson regression model|||"Week 3~P-value, mean and confidence interval calculated from a 0 inflated mixed poisson regression model with fixed effect terms for treatment, week, treatment by week interaction, baseline as a covariate and a random term for subject. The null hypothesis is that the ratio equals 1. Estimated means are conditional upon the random effect, assume a random effect of 0 and a covariate value at the average."||1.885|-0.111|0.8326
71098655|NCT03537729|141705807|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.02||0.04|TWO_SIDED|95.0|-0.07|-0.01||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Cues minus control.|The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.||-0.01|-0.07|.04
71098656|NCT03537729|141705807|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.02||0.1|TWO_SIDED|95.0|-0.07|0.01||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus control.|The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.||0.01|-0.07|.10
71098657|NCT03537729|141705807|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.69|TWO_SIDED|95.0|-0.03|0.04||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus cues only.|The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.||0.04|-0.03|.69
70989617|NCT03161938|141487501|SUPERIORITY|||||||0.59|||||||Chi-squared, Corrected|||Day 2||||0.590
70989618|NCT03161938|141487501|SUPERIORITY|||||||0.32|||||||Chi-squared, Corrected|||Day 3||||0.320
70989619|NCT03161938|141487501|SUPERIORITY|||||||0.666|||||||Chi-squared, Corrected|||day 4||||0.666
70989620|NCT03161938|141487502|SUPERIORITY||||||>|0.999|||||||Chi-squared, Corrected|||day 0||||>0.999
70989621|NCT03161938|141487502|SUPERIORITY|||||||0.154|||||||Chi-squared, Corrected|||day 1||||0.154
70989622|NCT03161938|141487502|SUPERIORITY|||||||0.447|||||||Chi-squared, Corrected|||day 2||||0.447
70989623|NCT03161938|141487502|SUPERIORITY|||||||0.678|||||||Chi-squared, Corrected|||day 3||||0.678
70989624|NCT03161938|141487502|SUPERIORITY|||||||0.604|||||||Chi-squared, Corrected|||day 4||||0.604
70989625|NCT03161938|141487503|SUPERIORITY|||||||0.075|||||||Chi-squared, Corrected|||day 0, sadness||||0.075
70989626|NCT03161938|141487503|SUPERIORITY|||||||0.447|||||||Chi-squared, Corrected|||day 0, restlessness||||0.447
70989627|NCT03161938|141487503|SUPERIORITY|||||||0.703|||||||Chi-squared, Corrected|||Day 0, fatigue||||0.703
71038827|NCT01370863|141585004|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-1.452||||0.869|TWO_SIDED|95.0|-19.054|16.149|||ANCOVA|||||16.149|-19.054|0.869
70989628|NCT03161938|141487503|SUPERIORITY|||||||0.731|||||||Chi-squared, Corrected|||Day 1, sadness||||0.731
70989629|NCT03161938|141487503|SUPERIORITY|||||||0.052|||||||Chi-squared, Corrected|||Day 1, restlessness||||0.052
70989630|NCT03161938|141487503|SUPERIORITY|||||||0.807|||||||Chi-squared, Corrected|||Day 1, fatigue||||0.807
70989631|NCT03161938|141487503|SUPERIORITY|||||||0.371|||||||Chi-squared, Corrected|||Day 2, sadness||||0.371
70989632|NCT03161938|141487503|SUPERIORITY|||||||0.064|||||||Chi-squared, Corrected|||Day 2, restlessness||||0.064
70989633|NCT03161938|141487503|SUPERIORITY|||||||0.11|||||||Chi-squared, Corrected|||day 2, fatigue||||0.110
70989634|NCT03161938|141487503|SUPERIORITY|||||||0.531|||||||Chi-squared, Corrected|||Day 3, sadness||||0.531
70989635|NCT03161938|141487503|SUPERIORITY|||||||0.954|||||||Chi-squared, Corrected|||Day 3, restlessness||||0.954
70989636|NCT03161938|141487503|SUPERIORITY|||||||0.526|||||||Chi-squared, Corrected|||Day 3, fatigue||||0.526
70989637|NCT03161938|141487503|SUPERIORITY|||||||0.491|||||||Chi-squared, Corrected|||Day 4, sadness||||0.491
70989638|NCT03161938|141487503|SUPERIORITY|||||||0.042|||||||Chi-squared, Corrected|||Day 4, restlessness||||0.042
70989639|NCT03161938|141487503|SUPERIORITY|||||||0.097|||||||Chi-squared, Corrected|||Day 4, fatigue||||0.097
70989640|NCT03161938|141487504|SUPERIORITY|||||||0.613|||||||Chi-squared, Corrected|||||||0.613
70989641|NCT00069576|141487559|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.87||||0.14|TWO_SIDED|97.0|0.72|1.07|||Chi-squared|||For Total Composite End Point||1.07|0.72|0.14
70989642|NCT00069576|141487559|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.06||||0.75|TWO_SIDED|97.0|0.73|1.53|||Chi-squared|||Analysis for Hypoglycemia||1.53|0.73|0.75
70989643|NCT00069576|141487559|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.74||||0.12|TWO_SIDED|97.0|0.49|1.12|||Chi-squared|||Analysis for hyperbilirubinemia||1.12|0.49|0.12
70989644|NCT00069576|141487559|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.78||||0.07|TWO_SIDED|97.0|0.57|1.05|||Chi-squared|||Analysis for elevated cord-blood C-peptide level||1.05|0.57|0.07
70989645|NCT00069576|141487559|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.48||||0.33|TWO_SIDED|97.0|0.1|2.2|||Chi-squared|||Analysis for birth trauma||2.20|0.10|0.33
70989646|NCT00069576|141487560|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.68|1.28||||||||1.28|0.68|
70989647|NCT00069576|141487561|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49|||<|0.001|TWO_SIDED|97.0|0.32|0.76|||Chi-squared|||||0.76|0.32|<0.001
70989648|NCT00069576|141487562|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.41|||<|0.001|TWO_SIDED|97.0|0.26|0.66|||Chi-squared|||||0.66|0.26|<0.001
70989649|NCT00069576|141487563|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81||||0.27|TWO_SIDED|97.0|0.53|1.23|||Chi-squared|||||1.23|0.53|0.27
70989650|NCT00069576|141487564|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
70989651|NCT00069576|141487565|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.18||||0.49|TWO_SIDED|97.0|0.7|1.99|||Chi-squared|||||1.99|0.70|0.49
70989652|NCT00069576|141487566|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70989653|NCT00069576|141487567|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77||||0.19|TWO_SIDED|97.0|0.51|1.18|||Chi-squared|||||1.18|0.51|0.19
70989654|NCT00069576|141487568|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77||||0.32|TWO_SIDED|97.0|0.44|1.36|||Chi-squared|||||1.36|0.44|0.32
70989655|NCT00069576|141487569|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.66||||0.33|TWO_SIDED|97.0|0.26|1.67|||Chi-squared|||||1.67|0.26|0.33
70989656|NCT00069576|141487570|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02||||0.86|TWO_SIDED|97.0|0.81|1.29|||Chi-squared|||||1.29|0.81|0.86
70989657|NCT00069576|141487571|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79||||0.02|TWO_SIDED|97.0|0.64|0.99|||Chi-squared|||||0.99|0.64|0.02
70989658|NCT00069576|141487572|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.37||||0.02|TWO_SIDED|97.0|0.14|0.97|||Chi-squared|||||0.97|0.14|0.02
70989659|NCT00069576|141487573|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.46||||0.02|TWO_SIDED|97.0|0.22|0.97|||Chi-squared|||||0.97|0.22|0.02
70989660|NCT00069576|141487574|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.63||||0.01|TWO_SIDED|97.0|0.42|0.96|||Chi-squared|||||0.96|0.42|0.01
70989661|NCT00069576|141487575|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70989662|NCT00069576|141487576|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70989663|NCT00069576|141487577|SUPERIORITY||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.71|1.1||||||||1.10|0.71|
70989664|NCT00069576|141487578|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.65|1.69||||||||1.69|0.65|
70989665|NCT00069576|141487579|SUPERIORITY||Risk Ratio (RR)|1.23|||||TWO_SIDED|95.0|0.74|2.05||||||||2.05|0.74|
70989666|NCT00069576|141487580|SUPERIORITY||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.36|1.62||||||||1.62|0.36|
70989667|NCT00069576|141487581|SUPERIORITY_OR_OTHER|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
71038828|NCT01370863|141585005|SUPERIORITY_OR_OTHER_LEGACY||Diference in LS means|0.264||||0.487|TWO_SIDED|95.0|-0.495|1.024|||ANCOVA|||||1.024|-0.495|0.487
71038829|NCT01370863|141585006|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-0.087||||0.637|TWO_SIDED|95.0|-0.501|0.326|||ANCOVA|||||0.326|-0.501|0.637
71038830|NCT00270634|141585028|NON_INFERIORITY_OR_EQUIVALENCE|The sample size was determined holding the probability of a type-I error at a = 0.05, and the power at 0.76. The rate of BPAR at 6 months posttransplant was assumed to be 0.20 in the control arm, and the noninferiority margin was chosen to be -0.15. A sample size for this phase-2b trial is determined to be 76 subjects in each dose group or a total of 304 patients. Assuming a 10% dropout rate during the study, ∼332 subjects were to be proportionally randomized in this study.|Weighted Average Difference|-3.2|||||ONE_SIDED|95.0||1.3|||t-test, 1 sided||The upper bound of the confidence interval was a measure of non-inferiority of VCS to TAC. VCS was considered non-inferior to TAC if the upper one-sided 95% confidence bound was less than 15%.|The 6-month BPAR rate was used to calculate an estimate of the difference in rates between each VCS group and TAC, combining across pooled investigative center strata, weighted by the number of patients in each of the pooled center strata. The overall standard error was estimated for the linear combination of proportions. Using this statistic and its standard error, the upper bound one-sided 95% C.I. was constructed for the difference in BPAR rates between groups (VCS - TAC).||1.3||
70989668|NCT00830037|141487610|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35||||0.79|TWO_SIDED|95.0|-2.9|2.3||a = 0.05|Mixed Models Analysis|Wald test||The analysis of the primary outcome was intention to treat, if the patient received at least one dose of the randomized drug (which was the case for each subject). A linear mixed model was used with GFR as the outcome variable. Fixed effects were indicator variables for time (treated as a continuous variable), treatment, and their interaction. Random effects were subject and time with unstructured covariance; statistical inference was made using the maximum likelihood estimator.||2.3|-2.9|0.79
70989669|NCT00830037|141487611|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.035||||0.83|TWO_SIDED|95.0|-0.294|0.365||a = 0.05|Mixed Models Analysis|Wald test||The secondary analysis examined the mean change from baseline proteinuria (log protein to creatinine ratio) at 2 years. The between-groups difference in mean change from baseline is reported with a 95% confidence interval and the p-value from the Wald test.||0.365|-0.294|0.83
70989670|NCT00752609|141487612|SUPERIORITY_OR_OTHER||Mean change from baseline|-0.42|||||TWO_SIDED|95.0|-0.65|-0.19|||||A two-sided 95% CI of the estimated mean change from Baseline in hemoglobin was derived from the t-distribution.|||-0.19|-0.65|
70989671|NCT00752609|141487612|SUPERIORITY_OR_OTHER||Mean change from baseline|0.49|||||TWO_SIDED|95.0|0.26|0.71|||||A two-sided 95% CI of the estimated mean change from Baseline in hemoglobin was derived from the t-distribution.|||0.71|0.26|
70989672|NCT01254396|141487630|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Means|41.35|||||TWO_SIDED|90.0|32.4|52.76||||||Natural log transformed Cmax of sildenafil was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios.||52.76|32.40|
70989673|NCT01254396|141487632|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Means|93.42|||||TWO_SIDED|90.0|80.23|108.78||||||Natural log transformed AUC (0-∞) of sildenafil was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios.||108.78|80.23|
70989674|NCT01254396|141487633|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Means|87.66|||||TWO_SIDED|90.0|77.62|98.99||||||Natural log transformed AUClast of sildenafil was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios.||98.99|77.62|
71038831|NCT00270634|141585028|NON_INFERIORITY_OR_EQUIVALENCE|The sample size was determined holding the probability of a type-I error at a = 0.05, and the power at 0.76. The rate of BPAR at 6 months posttransplant was assumed to be 0.20 in the control arm, and the noninferiority margin was chosen to be -0.15. A sample size for this phase-2b trial is determined to be 76 subjects in each dose group or a total of 304 patients. Assuming a 10% dropout rate during the study, ∼332 subjects were to be proportionally randomized in this study.|Weighted Average Difference|4.6|||||ONE_SIDED|95.0||10.8|||t-test, 1 sided||The upper bound of the confidence interval was a measure of non-inferiority of VCS to TAC. VCS was considered non-inferior to TAC if the upper one-sided 95% confidence bound was less than 15%.|||10.8||
71038832|NCT00270634|141585028|NON_INFERIORITY_OR_EQUIVALENCE|The sample size was determined holding the probability of a type-I error at a = 0.05, and the power at 0.76. The rate of BPAR at 6 months posttransplant was assumed to be 0.20 in the control arm, and the noninferiority margin was chosen to be -0.15. A sample size for this phase-2b trial is determined to be 76 subjects in each dose group or a total of 304 patients. Assuming a 10% dropout rate during the study, ∼332 subjects were to be proportionally randomized in this study.|Weighted Average Difference|4.9|||||ONE_SIDED|95.0||11.4|||t-test, 1 sided||The upper bound of the confidence interval was a measure of non-inferiority of VCS to TAC. VCS was considered non-inferior to TAC if the upper one-sided 95% confidence bound was less than 15%.|||11.4||
71038833|NCT03277248|141585071|SUPERIORITY||Rate Ratio (Ublituximab / Teriflunomide)|0.509||||0.0022|TWO_SIDED|95.0|0.33|0.784||GEE (Generalized Estimating Equation) model for the relapse count per participant with logarithmic link function, treatment, region, and baseline Expanded Disability Status Scale (EDSS) strata as covariates and log (years of treatment) as offset.|Negative Binomial Model|||||0.784|0.330|0.0022
71038834|NCT03277248|141585072|SUPERIORITY||Rate Ratio (Ublituximab / Teriflunomide)|0.035|||<|0.0001|TWO_SIDED|95.0|0.019|0.064||GEE model for the relapse count per participant with logarithmic link function, treatment, region, and baseline EDSS strata as covariates and log (years of treatment) as offset.|Negative Binomial Model|||||0.064|0.019|<.0001
70989675|NCT02492750|141487645|OTHER||Maximum Tolerated Dose (MTD) Level|3.0|||||TWO_SIDED||||||||MTD is defined as the dose level below the lowest dose that induces DLT in at least one-third of patients. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD.|||||
71038835|NCT03277248|141585073|SUPERIORITY||Rate Ratio (Ublituximab / Teriflunomide)|0.1|||<|0.0001|TWO_SIDED|95.0|0.073|0.136||GEE model for the relapse count per participant with logarithmic link function, treatment, region, and baseline EDSS strata as covariates and log (years of treatment) as offset.|Negative Binomial Model|||||0.136|0.073|<.0001
71038836|NCT03277248|141585075|SUPERIORITY||Odds Ratio (Ublituximab / Teriflunomide)|7.946|||<|0.0001|TWO_SIDED|95.0|4.917|12.841||Logistic regression model with treatment, region, baseline EDSS strata and log transformed baseline MRI lesion counts (T1-unenhancing, T2, Gd-enhancing) as covariates.|Regression, Logistic|||||12.841|4.917|<.0001
70989676|NCT05281523|141487684|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, visit by baseline, and visit by treatment group.|Difference in Least Square Means|-0.6||||0.004|TWO_SIDED|95.0|-1.0|-0.2|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP||-0.2|-1.0|0.004
71038837|NCT03277248|141585076|SUPERIORITY||Odds Ratio (Ublituximab / Teriflunomide)|0.862||||0.429|TWO_SIDED|95.0|0.596|1.246||Logistic regression model with treatment, region, baseline EDSS strata and log transformed baseline MRI lesion counts (T1 unenhancing, T2, Gd enhancing) as covariates.|Regression, Logistic|||||1.246|0.596|0.4290
70989677|NCT05281523|141487685|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, subgroup, visit by baseline, visit by treatment group.|Difference in Least Square Means|-0.25||||0.025|TWO_SIDED|95.0|-0.46|-0.03|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP||-0.03|-0.46|0.025
70989678|NCT05281523|141487686|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, subgroup, visit by baseline, visit by treatment group, subgroup by treatment group and subgroup by visit by treatment group.|Difference in Least Square Means|-0.18||||0.125|TWO_SIDED|95.0|-0.4|0.05|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 49 to Week 52 in participants with a diagnosis of CRSwNP||0.05|-0.40|0.125
70989679|NCT05281523|141487687|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, subgroup, visit by baseline, visit by treatment group, subgroup by treatment group and subgroup by visit by treatment group. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Difference in Least Square Means|-0.26||||0.007|TWO_SIDED|95.0|-0.45|-0.07|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 49 to Week 52 in participants with a diagnosis of CRSwNP||-0.07|-0.45|0.007
70989680|NCT05281523|141487688|OTHER|Analysis performed using an analysis of covariance model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region and previous surgery for nasal polyps. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level|Difference in Least Square Means|-3.2|||<|0.001|TWO_SIDED|95.0|-4.4|-2.0|||ANCOVA|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP||-2.0|-4.4|<0.001
70989681|NCT05281523|141487689|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, visit by baseline, and visit by treatment group. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Difference in Least Square Means|-9.9||||0.015|TWO_SIDED|95.0|-17.9|-2.0|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP||-2.0|-17.9|0.015
71038838|NCT03277248|141585077|SUPERIORITY||Least Squares Mean Difference|-0.018||||0.3108|TWO_SIDED|95.0|-0.053|0.017||Mixed model repeated measures (MMRM) model includes treatment, region, baseline EDSS strata, visit, treatment-by-visit interaction, and baseline volume (cube root transformed) as covariates and an unstructured covariance matrix.|Mixed Model Repeated Measures|||||0.017|-0.053|0.3108
70989682|NCT05281523|141487690|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, visit by baseline, and visit by treatment group. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Difference in Least Square Means|-0.24||||0.016|TWO_SIDED|95.0|-0.43|-0.04|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 21 to Week 24 in participants with a diagnosis of CRSwNP||-0.04|-0.43|0.016
70989683|NCT05281523|141487691|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, visit by baseline, and visit by treatment group. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Difference in Least Square Means|-0.3||||0.066|TWO_SIDED|95.0|-0.7|0.0|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 26 in participants with a diagnosis of CRSwNP||0.0|-0.7|0.066
70989684|NCT05281523|141487692|OTHER|Cox Proportional Hazards Model with covariates of treatment, baseline total endoscopic nasal polyps score, baseline nasal obstruction score (VRS), log(e) baseline blood eosinophil count, region, study and previous surgery for nasal polyps. The covariate for study is removed for the individual-study analyses.|Hazard Ratio (HR)|0.735||||0.128|TWO_SIDED|95.0|0.495|1.092|||Cox Proportional Hazards Model|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP (pooled analysis)||1.092|0.495|0.128
70989685|NCT05281523|141487693|OTHER|Cox Proportional Hazards Model with covariates of treatment, baseline total endoscopic nasal polyps score, baseline nasal obstruction score (VRS), log(e) baseline blood eosinophil count, region, study and previous surgery for nasal polyps. The covariate for study is removed for the individual-study analyses. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Hazard Ratio (HR)|0.713||||0.146|TWO_SIDED|95.0|0.453|1.124|||Cox Proportional Hazards Model|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP (pooled analysis)||1.124|0.453|0.146
70989686|NCT05281523|141487694|OTHER|Logistic regression with covariates of treatment, number of courses of systemic CS in 12 months prior to screening for NP (0, 1,\>1), log(e) baseline blood eosinophil count, baseline total endoscopic NP score, baseline nasal obstruction score (VRS), region, study and previous surgery for NPs. The study covariate is removed for individual study analyses. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Odds Ratio (OR)|0.58||||0.006|TWO_SIDED|95.0|0.4|0.86|||Regression, Logistic|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP (pooled analysis)||0.86|0.40|0.006
71038839|NCT00556673|141585199|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|||<|0.0001|TWO_SIDED|90.0|0.28|0.51||"Linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose FEV1 as covariate.~A significance level of 5% was used to determine statistical significance."|1-sided|||The primary hypothesis tested was that the change from period baseline of trough FEV1 for placebo and indacaterol/mometasone was equal. The one-sided alternative was that the increase from period baseline of trough FEV1 for indacaterol/mometasone was higher than for placebo.||0.51|0.28|< 0.0001
71038840|NCT01131260|141585214|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.31||||0.2|TWO_SIDED|95.0|0.87|1.98|||Chi-squared|||Analysis on primary composite outcome as a whole.||1.98|0.87|0.20
71038841|NCT01131260|141585216|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.02||||0.37|TWO_SIDED|95.0|0.31|29.1|||Fisher Exact|||||29.1|0.31|0.37
71038842|NCT01131260|141585217|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.86||||0.02|TWO_SIDED|95.0|1.13|7.24|||Chi-squared|||||7.24|1.13|0.02
71038843|NCT01131260|141585218|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.76||||1|TWO_SIDED|95.0|0.17|3.38|||Fisher Exact|||||3.38|0.17|1.0
71038844|NCT01131260|141585219|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.37||||0.13|TWO_SIDED|95.0|0.1|1.41|||Chi-squared|||||1.41|0.10|0.13
71038845|NCT01131260|141585220|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.57||||0.07|TWO_SIDED|95.0|0.97|2.54|||Chi-squared|||||2.54|0.97|0.07
71038846|NCT01131260|141585221|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81||||1|TWO_SIDED|95.0|0.22|3.0|||Fisher Exact|||||3.00|0.22|1.0
71038847|NCT01131260|141585222|SUPERIORITY_OR_OTHER|||||||0.17|||||||Chi-squared|||||||.17
71038848|NCT01131260|141585223|SUPERIORITY_OR_OTHER|||||||0.45||||||The p value was calculated based on the entire study cohort.|Chi-squared|||||||0.45
71038849|NCT01131260|141585225|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||.32
71038850|NCT01131260|141585226|SUPERIORITY_OR_OTHER|||||||0.35|||||||Chi-squared|||||||0.35
71038851|NCT01131260|141585227|SUPERIORITY_OR_OTHER|||||||0.4|||||||Chi-squared|||||||0.40
71038852|NCT01131260|141585228|SUPERIORITY_OR_OTHER|||||||0.59|||||||Chi-squared|||||||0.59
71038853|NCT01131260|141585229|SUPERIORITY_OR_OTHER|||||||0.19|||||||Chi-squared|||||||.19
71038854|NCT01131260|141585230|SUPERIORITY_OR_OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
71038855|NCT01131260|141585231|SUPERIORITY_OR_OTHER|||||||0.28|||||||Chi-squared|||||||0.28
71038856|NCT01131260|141585232|SUPERIORITY_OR_OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
71038857|NCT01131260|141585233|SUPERIORITY_OR_OTHER|||||||0.98|||||||Chi-squared|||||||0.98
71038858|NCT01131260|141585234|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|||||||.05
71038859|NCT03544216|141585235|OTHER||||||<|0.001||||||"Results of post-hoc analyses comparing scores of each lens type to one another:~Habitual lens and multifocal contact lens: p \<0.001 Habitual lens and single vision lens: p \<0.001 Multifocal lens and single vision lens: p = 0.08"|Generalized linear models|||Generalized linear models (controlling for repeated measures) of crossover analyses was run to compare mean CLDEQ-8 scores with habitual, multifocal, and single vision contact lenses (controlling for order)||||<0.001
71038860|NCT03544216|141585235|OTHER|||||||0.5||||||Analysis controlled for order, visit, and repeated measures.|Generalized linear model|||A generalized linear model was run to determine if there was an interaction between lens type (single vision or multifocal) and refractive error (continuous, mean binocular spherical equivalent)||||0.5
71038861|NCT03544216|141585235|OTHER|||||||0.7||||||Analysis controlled for order, visit, and repeated measures.|Generalized linear model|||A generalized linear model was run to determine if there was an interaction between magnitude in accommodative lag (measured in diopters with a 2 diopter visual target) and lens type (single vision or multifocal)||||0.7
71038862|NCT03544216|141585235|OTHER|||||||0.3||||||Analysis controlled for order, visit, and repeated measures.|Generalized linear model|||A generalized linear model was run to determine if there was an interaction between lens type (single vision or multifocal) and age (continuous, measured in self-reported years)||||0.3
71038863|NCT03544216|141585235|OTHER|||||||0.047||||||Analysis controlled for order, visit, and repeated measures|Generalized linear model|||A generalized linear model was run to determine if there was an interaction between lens type (single vision or multifocal) and age (measured categorically as 30 to \<35 years old and 35 to 40 years old, by self report)|"Post-Hoc Testing comparing CLDEQ-8 scores and the interaction between lens type and age group (denoted by lens type\*age group) produced the following results:~p = 0.01 for MF\*\<35 age group compared to Single Vision (SV)\*\<35 age group p = 0.07 for MF\*\<35 age group compared to MF\*\>35 age group p \> 0.05 for MF\*\<35 age group compared to Single Vision (SV)\*\>35 age group p \> 0.05 for SV\*\<35 age group compared to SV\*\>35 age group p \>0.05 for SV\*\<35 age group compared to MF\*\>35 age group p \> 0.05 for MF\*\>35 age group compared to SV\*\>25 age group"|||0.047
71038864|NCT00835081|141585236|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.0||||||90.0|95.9|110.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||110|95.9|
71038865|NCT00835081|141585237|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.0||||||90.0|97.5|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||103|97.5|
70989687|NCT05281523|141487695|OTHER|The pooled statistical analyses was performed using a Mixed Models Repeated Measures (MMRM) model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, study, visit and interaction terms for visit by baseline score and visit by treatment group. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Difference in Least Square Means|-0.75||||0.004|TWO_SIDED|95.0|-1.26|-0.25|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP (pooled analysis).||-0.25|-1.26|0.004
70989688|NCT05513391|141487696|NON_INFERIORITY|Non inferiority for GMTs was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) of the GMT ratio was greater than (\>) 0.667 for each virus strain.|GMT Ratio|1.28|||||TWO_SIDED|95.0|0.948|1.73||||||Statistical analysis for A/H1N1||1.73|0.948|
70989689|NCT05513391|141487696|NON_INFERIORITY|Non inferiority for GMTs was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio was \> 0.667 for each virus strain.|GMT Ratio|2.53|||||TWO_SIDED|95.0|1.93|3.3||||||Statistical analysis for A/H3N2||3.30|1.93|
70989690|NCT05513391|141487696|NON_INFERIORITY|Non inferiority for GMTs was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio was \> 0.667 for each virus strain.|GMT Ratio|0.515|||||TWO_SIDED|95.0|0.397|0.668||||||Statistical analysis for B/Victoria||0.668|0.397|
70989691|NCT05513391|141487696|NON_INFERIORITY|Non inferiority for GMTs was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio was \> 0.667 for each virus strain.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.799|1.3||||||Statistical analysis for B/Yamagata||1.30|0.799|
70989692|NCT05513391|141487697|NON_INFERIORITY|Non-inferiority for SC was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for the 4 strains.|Difference in percentage of participants|7.1|||||TWO_SIDED|95.0|-1.55|15.7||||||Statistical analysis for A/H1N1||15.7|-1.55|
70989693|NCT05513391|141487697|NON_INFERIORITY|Non-inferiority for SC was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for the 4 strains.|Difference in percentage of participants|15.4|||||TWO_SIDED|95.0|5.8|24.7||||||Statistical analysis for A/H3N2||24.7|5.80|
70989694|NCT05513391|141487697|NON_INFERIORITY|Non-inferiority for SC was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for the 4 strains.|Difference in percentage of participants|-6.91|||||TWO_SIDED|95.0|-14.02|0.1||||||Statistical analysis for B/Victoria||0.10|-14.02|
70989695|NCT05513391|141487697|NON_INFERIORITY|Non-inferiority for SC was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for the 4 strains.|Difference in percentage of participants|5.81|||||TWO_SIDED|95.0|-1.99|13.6||||||Statistical analysis for B/Yamagata||13.6|-1.99|
70989696|NCT05513053|141487718|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the two-sided 95% confidence interval (CI) of the ratio of GMTs between groups (9 to 17 years/18 to 49 years) was \> 0.667 for each strain.|GMT Ratio|1.98|||||TWO_SIDED|95.0|1.73|2.27||||||Statistical analysis for A/H1N1||2.27|1.73|
70989697|NCT05513053|141487718|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (9 to 17 years/18 to 49 years) was \> 0.667 for each strain.|GMT Ratio|3.27|||||TWO_SIDED|95.0|2.76|3.87||||||Statistical analysis for A/H3N2||3.87|2.76|
70989698|NCT05513053|141487718|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (9 to 17 years/18 to 49 years) was \> 0.667 for each strain.|GMT Ratio|1.57|||||TWO_SIDED|95.0|1.35|1.82||||||Statistical analysis for B/Victoria||1.82|1.35|
70989699|NCT05513053|141487718|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (9 to 17 years/18 to 49 years) was \> 0.667 for each strain.|GMT Ratio|1.22|||||TWO_SIDED|95.0|1.09|1.37||||||Statistical analysis for B/Yamagata||1.37|1.09|
70989700|NCT05513053|141487719|NON_INFERIORITY|Non-inferiority for seroconversion rates was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for the 4 strains.|Percent Difference|1.92|||||TWO_SIDED|95.0|-2.78|6.62||||||Statistical analysis for A/H1N1||6.62|-2.78|
70989701|NCT05513053|141487719|NON_INFERIORITY|Non-inferiority for seroconversion rates was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for the 4 strains.|Percent Difference|-0.59|||||TWO_SIDED|95.0|-4.41|3.23||||||Statistical analysis for A/H3N2||3.23|-4.41|
70989702|NCT05513053|141487719|NON_INFERIORITY|Non-inferiority for seroconversion rates was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for the 4 strains.|Percent Difference|3.29|||||TWO_SIDED|95.0|-1.57|8.14||||||Statistical analysis for B/Victoria||8.14|-1.57|
70989703|NCT05513053|141487719|NON_INFERIORITY|Non-inferiority for seroconversion rates was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for the 4 strains.|Percent Difference|14.3|||||TWO_SIDED|95.0|9.17|19.3||||||Statistical analysis for B/Yamagata||19.3|9.17|
70989704|NCT01520324|141487740|OTHER|The data documented in this trial and the parameters measured were described using classic statistics, i.e. mean, SD, CV(%), median, minimum and maximum values for quantitative variables and frequencies for qualitative variables.||||||||||||||||The number of detected neoplasiae for each patient was listed and summarised by descriptive statistics. Number and percentage of patients with intraepithelial neoplasiae was presented|The data documented in this trial and the parameters measured were described using classic statistics, i.e. mean, SD, CV(%), median, minimum and maximum values for quantitative variables and frequencies for qualitative variables.|||
70989705|NCT02163993|141487759|SUPERIORITY||Posterior Mean Difference|-0.57|STANDARD_DEVIATION|0.42|||TWO_SIDED|95.0|-1.4|0.24|||Bayesian Dose Response Model|||||0.24|-1.40|
70989706|NCT02163993|141487759|SUPERIORITY||Posterior Mean Difference|-0.25|STANDARD_DEVIATION|0.41|||TWO_SIDED|95.0|-1.06|0.56|||Bayesian Dose Response Model|||||0.56|-1.06|
70989707|NCT02163993|141487759|SUPERIORITY||Posterior Mean Difference|-1.14|STANDARD_DEVIATION|0.44|||TWO_SIDED|95.0|-2.02|-0.29|||Bayesian Dose Response Model|||||-0.29|-2.02|
70989708|NCT02163993|141487759|SUPERIORITY||Posterior Mean Difference|-0.62|STANDARD_DEVIATION|0.45|||TWO_SIDED|95.0|-1.5|0.27|||Bayesian Dose Response Model|||||0.27|-1.50|
70989709|NCT02658994|141487777|SUPERIORITY||Mean Difference (Final Values)|-0.13|||||TWO_SIDED|95.0|-0.33|0.07||||||||0.07|-0.33|
70989710|NCT02658994|141487778|SUPERIORITY||Median Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-1.39|1.19||||||||1.19|-1.39|
70989711|NCT02658994|141487779|SUPERIORITY||Mean Difference (Final Values)|-0.12|||||TWO_SIDED|95.0|-0.33|0.09||||||||0.09|-0.33|
70989712|NCT02658994|141487780|SUPERIORITY||Mean Difference (Final Values)|0.38|||||TWO_SIDED|95.0|-0.19|0.96||||||Child Bayley scaled receptive score||0.96|-0.19|
70989713|NCT02658994|141487780|SUPERIORITY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-0.83|0.9||||||Child Bayley scaled fine motor score||0.90|-0.83|
70989714|NCT02658994|141487781|SUPERIORITY||Risk Ratio (RR)|0.67|||||TWO_SIDED|95.0|0.43|1.05||||||||1.05|0.43|
70989715|NCT02658994|141487782|SUPERIORITY||Risk Ratio (RR)|-0.09|||||TWO_SIDED|95.0|-0.32|0.15||||||Length-for-age z-scores||0.15|-0.32|
70989716|NCT02658994|141487782|SUPERIORITY||Risk Ratio (RR)|-0.12|||||TWO_SIDED|95.0|-0.33|0.1||||||Weight-for-age z-scores||0.10|-0.33|
70989717|NCT00262080|141487807|SUPERIORITY_OR_OTHER_LEGACY|||||||0.037||95.0||||no adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|non-parametric Wilcoxon Rank Sum test|||The primary efficacy analysis compared the TOS at 4 hours post-dosing for patients treated with ecallantide and placebo. Treatment effect was assessed by the non-parametric Wilcoxon Rank Sum test because of an assumed non-normal distribution.||||0.037
70989718|NCT00262080|141487808|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0||||No adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|Wilcoxon Rank Sum Test.|||The analysis compared the change from baseline in MSCS score at 4 hours post-dosing for patients treated with ecallantide and placebo. Treatment effect was assessed by the non-parametric Wilcoxon Rank Sum test because of an assumed non-normal distribution.||||0.044
70989719|NCT00262080|141487812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.055||95.0||||No adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|Log Rank|||The Log-Rank test was used to compare the time distribution between the two treatment groups.||||0.055
70989720|NCT02808312|141487822|OTHER|Two-sided 90% Confidence Intervals (CIs) were calculated for the ratios of geometric least-squares means (GLSMs) of PK parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.7869|||||TWO_SIDED|90.0|1.2885|2.4781||||||An analysis of variance (ANOVA) model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (AUClast) for each cohort.||2.4781|1.2885|
70989721|NCT02808312|141487822|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|2.4868|||||TWO_SIDED|90.0|1.6735|3.6954||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (AUClast) for each cohort.||3.6954|1.6735|
70989722|NCT02808312|141487822|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|6.324|||||TWO_SIDED|90.0|4.3675|9.1569||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (AUClast) for each cohort.||9.1569|4.3675|
70989723|NCT02808312|141487823|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.7628|||||TWO_SIDED|90.0|1.275|2.4374||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (AUCinf) for each cohort.||2.4374|1.2750|
70989724|NCT02808312|141487823|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|2.4559|||||TWO_SIDED|90.0|1.6531|3.6486||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (AUCinf) for each cohort.||3.6486|1.6531|
70989725|NCT02808312|141487823|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|6.2497|||||TWO_SIDED|90.0|4.2965|9.091||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (AUCinf) for each cohort.||9.0910|4.2965|
70989726|NCT02808312|141487824|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.5703|||||TWO_SIDED|90.0|1.0723|2.2995||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (Cmax) for each cohort.||2.2995|1.0723|
70989727|NCT02808312|141487824|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.7343|||||TWO_SIDED|90.0|1.2193|2.4667||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (Cmax) for each cohort.||2.4667|1.2193|
70989728|NCT02808312|141487824|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|2.5369|||||TWO_SIDED|90.0|1.7562|3.6648||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (Cmax) for each cohort.||3.6648|1.7562|
70989729|NCT02808312|141487835|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|0.8722|||||TWO_SIDED|90.0|0.6827|1.1144||||||||1.1144|0.6827|
70989730|NCT02808312|141487835|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.0731|||||TWO_SIDED|90.0|0.8295|1.3883||||||||1.3883|0.8295|
70989731|NCT02808312|141487835|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.1475|||||TWO_SIDED|90.0|0.8783|1.4992||||||||1.4992|0.8783|
70989732|NCT02808312|141487836|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|0.8188|||||TWO_SIDED|90.0|0.5837|1.1486||||||||1.1486|0.5837|
70989733|NCT02808312|141487836|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.1323|||||TWO_SIDED|90.0|0.8772|1.4615||||||||1.4615|0.8772|
70989734|NCT02808312|141487836|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.3563|||||TWO_SIDED|90.0|1.0468|1.7574||||||||1.7574|1.0468|
70989735|NCT02808312|141487837|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.0658|||||TWO_SIDED|90.0|0.8275|1.3726||||||||1.3726|0.8275|
70989736|NCT02808312|141487837|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.2942|||||TWO_SIDED|90.0|0.9663|1.7334||||||||1.7334|0.9663|
70989737|NCT02808312|141487837|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|0.8225|||||TWO_SIDED|90.0|0.5479|1.2347||||||||1.2347|0.5479|
70989738|NCT02808312|141487838|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.0806|||||TWO_SIDED|90.0|0.791|1.4762||||||||1.4762|0.7910|
70989739|NCT02808312|141487838|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.3729|||||TWO_SIDED|90.0|0.9663|1.9506||||||||1.9506|0.9663|
70989740|NCT02808312|141487838|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|0.903|||||TWO_SIDED|90.0|0.6142|1.3275||||||||1.3275|0.6142|
70989741|NCT02713230|141487839|SUPERIORITY||LSMD|-117.688|||<|0.0001|TWO_SIDED|95.0|-150.896|-84.48|||ANOVA|||||-84.480|-150.896|<0.0001
70989742|NCT02713230|141487840|SUPERIORITY||LSM treatment ratio|0.22|||<|0.0001|TWO_SIDED|95.0|0.131|0.371|||ANOVA|||||0.371|0.131|<0.0001
70989743|NCT02713230|141487841|SUPERIORITY||Treatment difference|0.116||||0.008|TWO_SIDED|95.0|0.032|0.2|||Cochran-Mantel-Haenszel|||||0.200|0.032|0.008
70989744|NCT02713230|141487842|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||<0.0001
70989745|NCT03100942|141487843|SUPERIORITY||Difference in Response Rates|15.6||||0.1597|TWO_SIDED|95.0|-6.3|37.6||P-values were obtained from Cochran-Mantel-Haenszel (CMH) test stratified by randomization stratification factors.|Cochran-Mantel-Haenszel||For the analysis of the difference in response rates, the data with missing response values were imputed by multiple imputation method with logistic regression.|||37.6|-6.3|0.1597
70989746|NCT03100942|141487843|SUPERIORITY||Difference in Response Rates|16.6||||0.1694|TWO_SIDED|95.0|-5.1|38.3||P-values were obtained from CMH test stratified by randomization stratification factors.|Cochran-Mantel-Haenszel||For the analysis of the difference in response rates, the data with missing response values were imputed by multiple imputation method with logistic regression.|||38.3|-5.1|0.1694
70989747|NCT03100942|141487843|SUPERIORITY||Difference in Response Rates|8.1||||0.3309|TWO_SIDED|95.0|-13.2|29.4||P-values were obtained from CMH test stratified by randomization stratification factors.|Cochran-Mantel-Haenszel||For the analysis of the difference in response rates, the data with missing response values were imputed by multiple imputation method with logistic regression.|||29.4|-13.2|0.3309
70989748|NCT03100942|141487844|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|1.05||0.2066|TWO_SIDED|95.0|-0.7|3.4|||MMRM|||Least Squares (LS) Means, 95% confidence interval (CI), and P-values were obtained from Mixed Effects Model for Repeated Measures (MMRM) with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||3.4|-0.7|0.2066
70989749|NCT03100942|141487844|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.04||0.3998|TWO_SIDED|95.0|-2.9|1.2|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||1.2|-2.9|0.3998
70989750|NCT03100942|141487844|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.04||0.5113|TWO_SIDED|95.0|-1.4|2.7|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||2.7|-1.4|0.5113
70989751|NCT03100942|141487845|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.47||0.9446|TWO_SIDED|95.0|-0.9|1.0|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||1.0|-0.9|0.9446
70989752|NCT03100942|141487845|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.47||0.3977|TWO_SIDED|95.0|-1.3|0.5|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||0.5|-1.3|0.3977
70989753|NCT03100942|141487845|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.47||0.4966|TWO_SIDED|95.0|-1.2|0.6|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||0.6|-1.2|0.4966
70989754|NCT03100942|141487846|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.1||0.9564|TWO_SIDED|95.0|-2.2|2.1|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||2.1|-2.2|0.9564
70989755|NCT03100942|141487846|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|1.07||0.2788|TWO_SIDED|95.0|-3.3|0.9|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||0.9|-3.3|0.2788
70989756|NCT03100942|141487846|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.06||0.8047|TWO_SIDED|95.0|-1.8|2.3|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||2.3|-1.8|0.8047
70989757|NCT03100942|141487847|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.46||0.6782|TWO_SIDED|95.0|-1.1|0.7|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||0.7|-1.1|0.6782
71038866|NCT00835081|141585238|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.8||||||90.0|97.4|102.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||102|97.4|
71038867|NCT00421304|141585239|SUPERIORITY|||||||0.218|||||||Wilcoxon's rank-sum test|||||||0.218
71038868|NCT00421304|141585239|SUPERIORITY|||||||0.643|||||||Wilcoxon's rank-sum test|||||||0.643
71038869|NCT00421304|141585239|SUPERIORITY|||||||0.677|||||||Wilcoxon's rank-sum test|||||||0.677
71038870|NCT00421304|141585240|SUPERIORITY|||||||0.257|||||||Wilcoxon's rank-sum test|||||||0.257
70989758|NCT03100942|141487847|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.45||0.9171|TWO_SIDED|95.0|-0.8|0.9|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||0.9|-0.8|0.9171
71038871|NCT00421304|141585240|SUPERIORITY|||||||0.726|||||||Wilcoxon's rank-sum test|||||||0.726
71038872|NCT00421304|141585240|SUPERIORITY|||||||0.551|||||||Wilcoxon's rank-sum test|||||||0.551
71038873|NCT00421304|141585241|SUPERIORITY|||||||0.591|||||||Wilcoxon's rank-sum test|||||||0.591
71038874|NCT00421304|141585241|SUPERIORITY|||||||0.393|||||||Wilcoxon's rank-sum test|||||||0.393
71038875|NCT00421304|141585241|SUPERIORITY|||||||0.586|||||||Wilcoxon's rank-sum test|||||||0.586
70989759|NCT03100942|141487847|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.45||0.4641|TWO_SIDED|95.0|-1.2|0.5|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||0.5|-1.2|0.4641
70989760|NCT04263142|141487848|OTHER||Ratio|0.998|||||TWO_SIDED|90.0|0.9263|1.0757|||||Analysis was performed using analysis of variance (ANOVA) with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-inf). Ratio of GSK3640254 200 mg tablets/capsules.|||1.0757|0.9263|
71038876|NCT00421304|141585242|SUPERIORITY|||||||0.894|||||||Wilcoxon's rank-sum test|||||||0.894
71038877|NCT00421304|141585242|SUPERIORITY|||||||0.674|||||||Wilcoxon's rank-sum test|||||||0.674
71038878|NCT00421304|141585242|SUPERIORITY|||||||0.636|||||||Wilcoxon's rank-sum test|||||||0.636
71038879|NCT00421304|141585243|SUPERIORITY|||||||0.397|||||||Wilcoxon's rank-sum test|||||||0.397
71038880|NCT00421304|141585243|SUPERIORITY|||||||0.238|||||||Wilcoxon's rank-sum test|||||||0.238
71038881|NCT00421304|141585243|SUPERIORITY|||||||0.461|||||||Wilcoxon's rank-sum test|||||||0.461
71038882|NCT00421304|141585244|SUPERIORITY|||||||0.322|||||||Wilcoxon's rank-sum test|||||||0.322
71038883|NCT00421304|141585244|SUPERIORITY|||||||0.747|||||||Wilcoxon's rank-sum test|||||||0.747
71038884|NCT00421304|141585244|SUPERIORITY|||||||0.717|||||||Wilcoxon's rank-sum test|||||||0.717
71038885|NCT00421304|141585245|SUPERIORITY|||||||0.847|||||||Wilcoxon's rank-sum test|||||||0.847
71038886|NCT00421304|141585245|SUPERIORITY|||||||1|||||||Wilcoxon's rank-sum test|||||||1.000
71038887|NCT00421304|141585245|SUPERIORITY|||||||1|||||||Wilcoxon's rank-sum test|||||||1.000
71038888|NCT00421304|141585246|SUPERIORITY|||||||0.653|||||||Wilcoxon's rank-sum test|||||||0.653
71038889|NCT00421304|141585246|SUPERIORITY|||||||0.283|||||||Wilcoxon's rank-sum test|||||||0.283
71038890|NCT00421304|141585246|SUPERIORITY|||||||0.411|||||||Wilcoxon's rank-sum test|||||||0.411
71038891|NCT00421304|141585247|SUPERIORITY|||||||0.988|||||||Wilcoxon's rank-sum test|||||||0.988
71038892|NCT00421304|141585247|SUPERIORITY|||||||0.832|||||||Wilcoxon's rank-sum test|||||||0.832
71038893|NCT00421304|141585247|SUPERIORITY|||||||0.748|||||||Wilcoxon's rank-sum test|||||||0.748
71038894|NCT00421304|141585248|SUPERIORITY|||||||0.28|||||||Wilcoxon's rank-sum test|||||||0.280
71038895|NCT00421304|141585248|SUPERIORITY|||||||0.108|||||||Wilcoxon's rank-sum test|||||||0.108
71038896|NCT00421304|141585248|SUPERIORITY|||||||1|||||||Wilcoxon's rank-sum test|||||||1.000
71038897|NCT00421304|141585249|SUPERIORITY|||||||0.742|||||||Wilcoxon's rank-sum test|||||||0.742
71038898|NCT00421304|141585249|SUPERIORITY|||||||0.486|||||||Wilcoxon's rank-sum test|||||||0.486
71038899|NCT00421304|141585249|SUPERIORITY|||||||0.49|||||||Wilcoxon's rank-sum test|||||||0.490
71038900|NCT00421304|141585250|SUPERIORITY|||||||1|||||||Wilcoxon's rank-sum test|||||||1.000
71038901|NCT00421304|141585251|SUPERIORITY|||||||0.05|||||||Wilcoxon's rank-sum test|||||||0.050
71038902|NCT00421304|141585252|SUPERIORITY|||||||0.008|||||||Wilcoxon's rank-sum test|||||||0.008
71038903|NCT00421304|141585253|SUPERIORITY|||||||0.012|||||||Wilcoxon's rank-sum test|||||||0.012
71038904|NCT00421304|141585254|SUPERIORITY||||||<|0.001|||||||Wilcoxon's rank-sum test|||||||<0.001
71038905|NCT02535923|141585311|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||.04
71038906|NCT02535923|141585311|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||||||.83
71038907|NCT02535923|141585312|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||||||.83
71038908|NCT02535923|141585313|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|||||||.003
71038909|NCT02535923|141585314|SUPERIORITY|||||||0.16|||||||Mixed Models Analysis|||||||.16
70989761|NCT04263142|141487849|OTHER||Ratio|1.002|||||TWO_SIDED|90.0|0.9321|1.0781|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-t). Ratio of GSK3640254 200 mg tablets/capsules.|||1.0781|0.9321|
70989762|NCT04263142|141487850|OTHER||Ratio|1.093|||||TWO_SIDED|90.0|0.9885|1.208|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter Cmax. Ratio of GSK3640254 200 mg tablets/capsules.|||1.2080|0.9885|
71038910|NCT02535923|141585315|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||||||.82
71038911|NCT00840879|141585342|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|98.15||||||90.0|90.96|105.9|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.90|90.96|
71038912|NCT00840879|141585343|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|96.34||||||90.0|91.82|101.07|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.07|91.82|
71038913|NCT00840879|141585344|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|97.76||||||90.0|93.31|102.42|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.42|93.31|
71038914|NCT00840840|141585345|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|101.45||||||90.0|97.71|105.33|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.33|97.71|
71038915|NCT00840840|141585346|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|103.05||||||90.0|101.25|104.88|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.88|101.25|
70989763|NCT04263142|141487852|OTHER||Ratio|2.926|||||TWO_SIDED|90.0|2.3703|3.6107|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-inf). Ratio of GSK3640254 200 mg tablet (moderate fat)/(fasted)|||3.6107|2.3703|
70989764|NCT04263142|141487852|OTHER||Ratio|2.594|||||TWO_SIDED|90.0|2.1003|3.2038|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-inf). Ratio of GSK3640254 200 mg tablet (high fat)/(fasted)|||3.2038|2.1003|
71038916|NCT00840840|141585347|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|102.94||||||90.0|101.08|104.83|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.83|101.08|
71038917|NCT00840840|141585348|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|99.68||||||90.0|92.41|107.52|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||107.52|92.41|
71038918|NCT00840840|141585349|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|101.48||||||90.0|94.73|108.71|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||108.71|94.73|
71038919|NCT00840840|141585350|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|100.17||||||90.0|91.95|109.13|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||109.13|91.95|
71038920|NCT02906813|141585380|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Ratio|0.631||||0.079|TWO_SIDED|90.0|0.411|0.969|||ANOVA|||Analysis of variance (ANOVA) was performed on natural logarithms of TAK-935 Cmax with fixed factors of sequence, period and regimen, and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative bioavailability (BA) of TAK-935 tablet to solution. Point estimate and 90 percent (%) confidence interval (CI) in original scale were obtained by exponentiation of differences in natural-log scale.||0.969|0.411|0.079
71038921|NCT02906813|141585380|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.403||||0.002|TWO_SIDED|90.0|0.262|0.618|||ANOVA|||ANOVA was performed on natural logarithms of TAK-935 Cmax with fixed factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 administered after high-fat meal versus fasted. Point estimate and its 90% confidence interval in original scale were obtained by exponentiation of differences in natural-log scale.||0.618|0.262|0.002
70989765|NCT04263142|141487853|OTHER||Ratio|3.146|||||TWO_SIDED|90.0|2.5925|3.8178|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-t). Ratio of GSK3640254 200 mg tablet (moderate fat)/(fasted)|||3.8178|2.5925|
71038922|NCT02906813|141585381|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.85||||0.146|TWO_SIDED|90.0|0.706|1.024|||ANOVA|||ANOVA was performed on natural logarithms of TAK-935 AUCt with fixed factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 tablet to solution. Point estimate and 90% CI in original scale were obtained by exponentiation of differences in natural-log scale.||1.024|0.706|0.146
71038923|NCT02906813|141585381|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.889||||0.281|TWO_SIDED|90.0|0.738|1.07|||ANOVA|||ANOVA was performed on natural logarithms of TAK-935 AUCt with factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 administered after high-fat meal versus fasted. Point estimate and its 90% CI in original scale were obtained by exponentiation of differences in natural-log scale.||1.070|0.738|0.281
71038924|NCT02906813|141585382|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.842||||0.191|TWO_SIDED|90.0|0.676|1.05|||ANOVA|||ANOVA was performed on natural logarithms of TAK-935 AUC∞ with fixed factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 tablet to solution. Point estimate and 90% CI in original scale were obtained by exponentiation of differences in natural-log scale.||1.050|0.676|0.191
71038925|NCT02906813|141585382|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.894||||0.355||90.0|0.726|1.1|||ANOVA|||ANOVA was performed on natural logarithms of TAK-935 AUC∞ with factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 administered after high-fat meal versus fasted. Point estimate and its 90% CI in original scale were obtained by exponentiation of differences in natural-log scale.||1.100|0.726|0.355
71038926|NCT04364854|141585394|OTHER|This study was not designed to perform a hypothesis test. No p-values will be reported.|Mean Difference (Net)|-0.22|||||TWO_SIDED|95.0|-2.31|1.87|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM, and age.|||1.87|-2.31|
71038927|NCT04364854|141585394|OTHER|This study was not designed to perform a hypothesis test. No p-values will be reported.|Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-2.94|3.15|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM, and age.|||3.15|-2.94|
71038928|NCT04364854|141585394|OTHER|This study was not designed to perform a hypothesis test. No p-values will be reported.|Mean Difference (Net)|-0.78|||||TWO_SIDED|95.0|-2.9|1.33|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM, and age.|||1.33|-2.9|
71038929|NCT04364854|141585395|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-0.26|0.13|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline SAQOL-39, and age.|||0.13|-0.26|
71038930|NCT04364854|141585395|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.21|0.28|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline SAQOL-39, and age.|||0.28|-0.21|
71038931|NCT04364854|141585395|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|-0.23|||||TWO_SIDED|95.0|-0.42|-0.04|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline SAQOL-39, and age.|||-0.04|-0.42|
71038932|NCT04364854|141585396|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|0.16|||||TWO_SIDED|95.0|-2.59|2.9|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM - Narrative, and age.|||2.9|-2.59|
71038933|NCT04364854|141585396|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|0.79|||||TWO_SIDED|95.0|-2.23|3.8|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM-Narrative, and age.|||3.8|-2.23|
71038934|NCT04364854|141585396|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|0.25|||||TWO_SIDED|95.0|-2.32|2.82|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM - Narrative, and age.|||2.82|-2.32|
71038935|NCT04364854|141585397|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-3.59|3.45|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM - Procedural, and age.|||3.45|-3.59|
71038936|NCT04364854|141585397|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|0.27|||||TWO_SIDED|95.0|-4.27|4.8|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM - Procedural, and age.|||4.8|-4.27|
71038937|NCT04364854|141585397|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|-2.11|||||TWO_SIDED|95.0|-5.77|1.56|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM - Procedural, and age.|||1.56|-5.77|
71038938|NCT02435433|141585398|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0199|TWO_SIDED|95.0|0.531|0.949|||Log Rank||Stratified analysis|||0.949|0.531|0.0199
71038939|NCT02435433|141585399|SUPERIORITY||Hazard Ratio (HR)|0.452|||<|0.0001|TWO_SIDED|95.0|0.339|0.603|||Log Rank||Stratified analysis|||0.603|0.339|<0.0001
71038940|NCT02435433|141585400|SUPERIORITY||Hazard Ratio (HR)|0.427|||<|0.0001|TWO_SIDED|95.0|0.313|0.582|||Log Rank||Stratified analysis|||0.582|0.313|<0.0001
71038941|NCT02435433|141585401|SUPERIORITY||Odds Ratio (OR)|4.6||||0.1697|TWO_SIDED|95.0|0.6|37.3|||Cochran-Mantel-Haenszel||Stratified analysis|||37.3|0.6|0.1697
71038942|NCT02435433|141585405|SUPERIORITY||Hazard Ratio (HR)|0.799||||0.2382|TWO_SIDED|95.0|0.545|1.171|||Log Rank||Stratified analysis|||1.171|0.545|0.2382
71038943|NCT02640235|141585450|NON_INFERIORITY|The logistic regression estimates are generated from predicted values of the fitted logistic regression model. If the lower bound of the 95% confidence interval is greater than -10, Celstat is non-inferior to Surgicel. If the lower bound of the 95% confidence interval is greater than 0, Celstat will be declared superior to Surgicel.|Difference in avg predicted proportion|-8.5|||||TWO_SIDED|95.0|-15.6|-1.4|||Regression, Logistic|||||-1.4|-15.6|
71038944|NCT02640235|141585453|OTHER||Difference in avg predicted proportion|4.7|||||TWO_SIDED|95.0|-3.6|13.1|||Regression, Logistic|||||13.1|-3.6|
71038945|NCT02640235|141585454|OTHER||Difference in avg predicted proportion|-6.2|||||TWO_SIDED|95.0|-12.0|-0.5|||Regression, Logistic|||||-0.5|-12|
70989766|NCT04263142|141487853|OTHER||Ratio|2.785|||||TWO_SIDED|90.0|2.2943|3.3807|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-t). Ratio of GSK3640254 200 mg tablet (high fat)/(fasted)|||3.3807|2.2943|
70989767|NCT04263142|141487854|OTHER||Ratio|4.101|||||TWO_SIDED|90.0|3.2442|5.183|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter Cmax. Ratio of GSK3640254 200 mg tablet (moderate fat)/(fasted)|||5.1830|3.2442|
70989768|NCT04263142|141487854|OTHER||Ratio|3.08|||||TWO_SIDED|90.0|2.4359|3.8935|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter Cmax. Ratio of GSK3640254 200 mg tablet (high fat)/(fasted)|||3.8935|2.4359|
70989769|NCT01623531|141487946|SUPERIORITY||Mann-Whitney U test|386.0|STANDARD_ERROR_OF_MEAN|47.5||0.908|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The distributions of cumulative transfusion units did not differ significantly between patients receiving either RiaSTAP (median = 0, IQR = 0-1) or Placebo (median = 0, IQR = 0.1), U = 386, SE = 47.60, p = .908.|Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that the data were not normally distributed, and primary outcomes were zero inflated. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in primary and secondary outcomes between groups 24 hours after infusion of the study drug.||||.908
70989770|NCT01623531|141487947|SUPERIORITY||Mean Difference (Net)|-0.498|STANDARD_ERROR_OF_MEAN|0.239||0.047|TWO_SIDED||||||t-test, 2 sided|Unequal variances assumed.|Unequal variances T-test comparing placebo to RiaSTAP.|We tested the null hypothesis of no difference in primary and secondary outcomes between groups 24 hours after infusion of the study drug. Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals. For normally distributed data unequal variance t tests were used.||||.047
70989771|NCT01623531|141487948|SUPERIORITY||Mean Difference (Net)|-0.004|STANDARD_ERROR_OF_MEAN|0.0116||0.729|TWO_SIDED||||||t-test, 2 sided|Unequal variances assumed.|Unequal variances T-test comparing placebo to RiaSTAP.|We tested the null hypothesis of no difference in primary and secondary outcomes between groups 24 hours after infusion of the study drug. Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals. For normally distributed data unequal variance t tests were used.||||.729
70989772|NCT01623531|141487949|SUPERIORITY||Mean Difference (Net)|-0.321|STANDARD_ERROR_OF_MEAN|3.699||0.93|TWO_SIDED||||||t-test, 2 sided|Unequal variances assumed.|Unequal variances T-test comparing placebo to RiaSTAP.|We tested the null hypothesis of no difference in primary and secondary outcomes between groups 24 hours after infusion of the study drug. Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals. For normally distributed data unequal variance t tests were used.||||.93
70989773|NCT01623531|141487950|SUPERIORITY||Mean Difference (Net)|-11.821|STANDARD_ERROR_OF_MEAN|8.471||0.169|TWO_SIDED||||||t-test, 2 sided|Unequal variances assumed.|Unequal variances T-test comparing placebo to RiaSTAP.|||||.169
70989774|NCT01623531|141487951|SUPERIORITY||Mann-Whitney U test|450.5|STANDARD_ERROR_OF_MEAN|54.163||0.035|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.035
70989775|NCT01623531|141487952|SUPERIORITY||Mann-Whitney U test|337.5|STANDARD_ERROR_OF_MEAN|51.591||0.794|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.794
70989776|NCT01623531|141487953|SUPERIORITY||Mann-Whitney U test|335.5|STANDARD_ERROR_OF_MEAN|52.957||0.828|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.828
70989777|NCT01623531|141487954|SUPERIORITY||Mann-Whitney U test|396.0|STANDARD_ERROR_OF_MEAN|60.944||0.941|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.941
71038946|NCT02640235|141585455|OTHER||Difference in avg predicted proportion|-0.7|||||TWO_SIDED|95.0|-5.7|4.3|||Regression, Logistic|||||4.3|-5.7|
70989778|NCT01623531|141487955|SUPERIORITY||Mann-Whitney U test|494.5|STANDARD_ERROR_OF_MEAN|60.783||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.09
71038947|NCT02640235|141585456|OTHER||Difference in avg predicted proportion|0.2|||||TWO_SIDED|95.0|-3.9|4.4|||Regression, Logistic|||||4.4|-3.9|
71038948|NCT01322633|141585458|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.24|1.93||||||Analysis was based on hazard ratio using Cox proportional hazard regression method adjusted for sex, age, cumulative PPI dose, total years of PPI treatment, diabetes, hepatitis C, hepatitis B and year of index date.||1.93|0.24|
71038949|NCT01322633|141585459|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.65|1.4||||||Analysis was based on hazard ratio using Cox proportional hazard regression method adjusted for sex, age, cumulative PPI dose, total years of PPI treatment, diabetes, hepatitis C, hepatitis B and year of index date.||1.40|0.65|
70989779|NCT01623531|141487956|SUPERIORITY||Mann-Whitney U test|418.5|STANDARD_ERROR_OF_MEAN|60.93||0.658|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.658
70989780|NCT01623531|141487957|SUPERIORITY||Mann-Whitney U test|472.5|STANDARD_ERROR_OF_MEAN|60.727||0.182|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.182
70989781|NCT01623531|141487958|SUPERIORITY||Mann-Whitney U test|428.0|STANDARD_ERROR_OF_MEAN|60.919||0.549|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.549
70989782|NCT01623531|141487959|SUPERIORITY||Mann-Whitney U test|530.5|STANDARD_ERROR_OF_MEAN|60.816||0.022|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The distribution of FIBTEM MCF (maximum clot firmness) was significantly different between RiaSTAP (median = 27 mm, IQR = 24, 30), and placebo (median = 23 mm, IQR = 22, 27) groups, U-test = 530.5, SE = 60.816, p = .022).|Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that the FIBTEM MCF data was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.022
70989783|NCT01623531|141487960|SUPERIORITY||Mann-Whitney U test|437.0|STANDARD_ERROR_OF_MEAN|60.93||0.455|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.455
70989784|NCT01623531|141487961|SUPERIORITY||Mann-Whitney U test|432.5|STANDARD_ERROR_OF_MEAN|60.819||0.5|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.5
70989785|NCT01623531|141487962|SUPERIORITY|||||||1|||||||Fisher Exact|Significance (2-sided) using Fisher's Exact Test.||||||1.0
70989786|NCT04184622|141487977|SUPERIORITY||Least Square (LS) Mean Difference (Net)|-13.5|||<|0.001|TWO_SIDED|95.0|-14.6|-12.5|||Mixed Models Analysis|||||-12.5|-14.6|<0.001
70989787|NCT04184622|141487977|SUPERIORITY||LS Mean Difference (Net)|-18.9|||<|0.001|TWO_SIDED|95.0|-20.0|-17.8|||Mixed Models Analysis|||||-17.8|-20.0|<0.001
70989788|NCT04184622|141487977|SUPERIORITY||LS Mean Difference (Net)|-20.1|||<|0.001|TWO_SIDED|95.0|-21.2|-19.0|||Mixed Models Analysis|||||-19.0|-21.2|<0.001
70989789|NCT04184622|141487978|SUPERIORITY||Odds Ratio (OR)|23.99|||<|0.001|TWO_SIDED|95.0|17.43|33.02|||Regression, Logistic|||||33.02|17.43|<0.001
70989790|NCT04184622|141487978|SUPERIORITY||Odds Ratio (OR)|73.63|||<|0.001|TWO_SIDED|95.0|46.98|115.39|||Regression, Logistic|||||115.39|46.98|<0.001
71038950|NCT01322633|141585460|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.93|1.21||||||Analysis was based on hazard ratio using Cox proportional hazard regression method adjusted for sex, age, cumulative PPI dose, total years of PPI treatment, diabetes, hepatitis C, hepatitis B and year of index date.||1.21|0.93|
70989791|NCT04184622|141487978|SUPERIORITY||Odds Ratio (OR)|75.48|||<|0.001|TWO_SIDED|95.0|47.86|119.03|||Regression, Logistic|||||119.03|47.86|<0.001
70989792|NCT04184622|141487979|SUPERIORITY||LS Mean Difference (Net)|-10.7|||<|0.001|TWO_SIDED|95.0|-11.2|-10.1|||Mixed Models Analysis|||||-10.1|-11.2|<0.001
70989793|NCT04184622|141487980|SUPERIORITY||Odds Ratio (OR)|19.03|||<|0.001|TWO_SIDED|95.0|14.15|25.6|||Regression, Logistic|||||25.60|14.15|<0.001
70989794|NCT04184622|141487980|SUPERIORITY||Odds Ratio (OR)|44.17|||<|0.001|TWO_SIDED|95.0|31.75|61.45|||Regression, Logistic|||||61.45|31.75|<.001
70989795|NCT04184622|141487980|SUPERIORITY||Odds Ratio (OR)|65.64|||<|0.001|TWO_SIDED|95.0|45.94|93.77|||Regression, Logistic|||||93.77|45.94|<.001
70989796|NCT04184622|141487981|SUPERIORITY||Odds Ratio (OR)|17.08|||<|0.001|TWO_SIDED|95.0|11.83|24.66|||Regression, Logistic|||||24.66|11.83|<0.001
70989797|NCT04184622|141487981|SUPERIORITY||Odds Ratio (OR)|51.84|||<|0.001|TWO_SIDED|95.0|35.42|75.88|||Regression, Logistic|||||75.88|35.42|<0.001
70989798|NCT04184622|141487981|SUPERIORITY||Odds Ratio (OR)|66.63|||<|0.001|TWO_SIDED|95.0|45.23|98.16|||Regression, Logistic|||||98.16|45.23|<0.001
70989799|NCT04184622|141487982|SUPERIORITY||Odds Ratio (OR)|36.93|||<|0.001|TWO_SIDED|95.0|18.37|74.22|||Regression, Logistic|||||74.22|18.37|<0.001
70989800|NCT04184622|141487982|SUPERIORITY||Odds Ratio (OR)|109.45|||<|0.001|TWO_SIDED|95.0|54.5|219.81|||Regression, Logistic|||||219.81|54.50|<0.001
70989801|NCT04184622|141487982|SUPERIORITY||Odds Ratio (OR)|150.59|||<|0.001|TWO_SIDED|95.0|74.85|302.97|||Regression, Logistic|||||302.97|74.85|<0.001
70989802|NCT04184622|141487983|SUPERIORITY||LS Mean Difference (Net)|-11.2|||<|0.001|TWO_SIDED|95.0|-12.3|-10.0|||Mixed Models Analysis|||||-10.0|-12.3|<0.001
70989803|NCT04184622|141487983|SUPERIORITY||LS Mean Difference (Net)|-16.0|||<|0.001|TWO_SIDED|95.0|-17.2|-14.9|||Mixed Models Analysis|||||-14.9|-17.2|<0.001
70989804|NCT04184622|141487983|SUPERIORITY||LS Mean Difference (Net)|-16.5|||<|0.001|TWO_SIDED|95.0|-17.7|-15.4|||Mixed Models Analysis|||||-15.4|-17.7|<0.001
71038951|NCT05109104|141585461|OTHER|The t value from the '2-sided' Student-t distribution table corresponding to the upper 5% point with n-1 degrees of freedom was obtained and the labeled SPF value was determined as the largest whole number less than the following calculation: Labeled SPF = Mean SPF - (t\*SE).|Labeled SPF|25.0|||||TWO_SIDED|||||||||||||
71038952|NCT05109104|141585461|OTHER|The t value from the '2-sided' Student-t distribution table corresponding to the upper 5% point with n-1 degrees of freedom was obtained and the labeled SPF value was determined as the largest whole number less than the following calculation: Labeled SPF = Mean SPF - (t\*SE).|Labeled SPF|25.0|||||TWO_SIDED|||||||||||||
71038953|NCT05109104|141585461|OTHER|The t value from the '2-sided' Student-t distribution table corresponding to the upper 5% point with n-1 degrees of freedom was obtained and the labeled SPF value was determined as the largest whole number less than the following calculation: Labeled SPF = Mean SPF - (t\*SE).|Labeled SPF|27.0|||||TWO_SIDED|||||||||||||
71038954|NCT02235870|141585485|SUPERIORITY||Least-Square Mean Difference|3.28||||0.0261|TWO_SIDED|95.0|2.24|4.32|||ANCOVA|||||4.32|2.24|0.0261
71038955|NCT02235870|141585486|SUPERIORITY||Exact Confidence Interval|64.9|||<|0.0001|TWO_SIDED|95.0|57.5|71.7|||Exact Test|||Subjects in the Obalon Treatment group with at least 2 Balloons and balloon therapy for at least 18 weeks.||71.7|57.5|<0.0001
71038956|NCT02235870|141585487|SUPERIORITY||Percentage Difference|32.8|||<|0.0001|TWO_SIDED|95.0|23.1|42.5|||Chi-squared|||||42.5|23.1|<0.0001
71038957|NCT01046084|141585488|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.0|||||TWO_SIDED|90.0|86.5|123.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||123|86.5|
71038958|NCT01046084|141585489|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|104.0|||||TWO_SIDED|90.0|89.3|120.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||120|89.3|
71038959|NCT01046084|141585490|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|107.0|||||TWO_SIDED|90.0|92.5|123.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||123|92.5|
71038960|NCT02670551|141585535|SUPERIORITY||Least Squares Mean Difference|-2.5||||0.0331|TWO_SIDED|95.0|-4.6|-0.4||MMRM analysis was used. Fixed factors: treatment group, pooled study center, visit, treatment-group-by-visit interaction. Covariates: Baseline value, baseline value-by-visit interaction. P-value was adjusted by matched parallel gatekeeping procedure.|Mixed Model Repeated Measures (MMRM)|||To control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6 for the primary and secondary efficacy parameters, the parallel gatekeeping procedure was implemented.||-0.4|-4.6|0.0331
71038961|NCT02670551|141585535|SUPERIORITY||Least Squares Mean Difference|-3.0||||0.0103|TWO_SIDED|95.0|-5.1|-0.9||MMRM analysis was used. Fixed factors: treatment group, pooled study center, visit, treatment-group-by-visit interaction. Covariates: Baseline value, baseline value-by-visit interaction. P-value was adjusted by matched parallel gatekeeping procedure.|Mixed Model Repeated Measures (MMRM)|||To control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6 for the primary and secondary efficacy parameters, the parallel gatekeeping procedure was implemented.||-0.9|-5.1|0.0103
71038962|NCT02670551|141585536|SUPERIORITY||Least Squares Mean Difference|-0.2||||0.0714|TWO_SIDED|95.0|-0.5|0.0||MMRM analysis was used. Fixed factors: treatment group, pooled study center, visit, treatment-group-by-visit interaction. Covariates: Baseline value, baseline value-by-visit interaction. P-value was adjusted by matched parallel gatekeeping procedure.|Mixed Model Repeated Measures (MMRM)|||To control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6 for the primary and secondary efficacy parameters, the parallel gatekeeping procedure was implemented.||0.0|-0.5|0.0714
71038963|NCT02670551|141585536|SUPERIORITY||Least Squares Mean Difference|-0.3||||0.0662|TWO_SIDED|95.0|-0.5|0.0||MMRM analysis was used. Fixed factors: treatment group, pooled study center, visit, treatment-group-by-visit interaction. Covariates: Baseline value, baseline value-by-visit interaction. P-value was adjusted by matched parallel gatekeeping procedure.|Mixed Model Repeated Measures (MMRM)|||To control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6 for the primary and secondary efficacy parameters, the parallel gatekeeping procedure was implemented.||-0.0|-0.5|0.0662
71038964|NCT04476277|141585537|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71038965|NCT04476277|141585539|OTHER|||||||0.28|||||||t-test, 2 sided|||||||0.28
71038966|NCT04476277|141585540|OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
71038967|NCT04476277|141585541|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
71038968|NCT04476277|141585542|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
71038969|NCT04476277|141585543|OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.65
71038970|NCT04476277|141585544|OTHER|||||||0.48|||||||t-test, 2 sided|||||||0.48
71038971|NCT04476277|141585545|OTHER|||||||0.99|||||||t-test, 2 sided|||||||0.99
71038972|NCT04476277|141585546|OTHER|||||||0.39|||||||t-test, 2 sided|||||||0.39
71038973|NCT04476277|141585547|OTHER|||||||0.43|||||||t-test, 2 sided|||||||0.43
71038974|NCT04476277|141585548|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71038975|NCT04476277|141585549|OTHER|||||||0.01|||||||t-test, 1 sided|||||||0.01
71038976|NCT04476277|141585550|OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
70989805|NCT04184622|141487984|SUPERIORITY||LS Mean Difference (Net)|2.3|||<|0.001|TWO_SIDED|95.0|1.6|2.9|||ANCOVA|||||2.9|1.6|<0.001
70989806|NCT04184622|141487985|SUPERIORITY||Estimate Difference|-22.7|||<|0.001|TWO_SIDED|95.0|-25.6|-19.8|||Mixed Models Analysis|||||-19.8|-25.6|<0.001
70989807|NCT04184622|141487986|SUPERIORITY||Estimate Difference|-4.91|||<|0.001|TWO_SIDED|95.0|-6.4|-3.41|||Mixed Models Analysis|||||-3.41|-6.40|<0.001
70989808|NCT04184622|141487987|SUPERIORITY||Estimate Difference|7.65|||<|0.001|TWO_SIDED|95.0|5.85|9.49|||Mixed Models Analysis|||||9.49|5.85|<0.001
70989809|NCT04184622|141487988|SUPERIORITY||LS Mean Difference (Net)|-6.8|||<|0.001|TWO_SIDED|95.0|-7.9|-5.7|||Mixed Models Analysis|||||-5.7|-7.9|<0.001
70989810|NCT04184622|141487989|SUPERIORITY||Estimate Difference|-41.2|||<|0.001|TWO_SIDED|95.0|-44.9|-37.3|||Mixed Models Analysis|||||-37.3|-44.9|<0.001
70989811|NCT04184622|141487990|SUPERIORITY||LS Mean Difference (Net)|-13.2|||<|0.0001|TWO_SIDED|95.0|-15.3|-11.1|||Mixed Models Analysis|||||-11.1|-15.3|<.0001
70989812|NCT04184622|141487990|SUPERIORITY||LS Mean Difference (Net)|-17.7|||<|0.0001|TWO_SIDED|95.0|-19.8|-15.7|||Mixed Models Analysis|||||-15.7|-19.8|<.0001
70989813|NCT04184622|141487990|SUPERIORITY||LS Mean Difference (Net)|-20.7|||<|0.0001|TWO_SIDED|95.0|-22.8|-18.6|||Mixed Models Analysis|||||-18.6|-22.8|<.0001
70989814|NCT04184622|141487991|SUPERIORITY||Hazard Ratio (HR)|0.06|||<|0.0001|TWO_SIDED|95.0|0.03|0.13|||Regression, Cox|||||0.13|0.03|<0.0001
70989815|NCT04184622|141487992|SUPERIORITY||Hazard Ratio (HR)|0.12|||<|0.0001|TWO_SIDED|95.0|0.07|0.21|||Regression, Cox|||||0.21|0.07|<0.0001
70989816|NCT04184622|141487993|SUPERIORITY||LS Mean Difference (Net)|-5.1|||<|0.001|TWO_SIDED|95.0|-5.5|-4.6|||Mixed Models Analysis|||||-4.6|-5.5|<0.001
70989817|NCT04184622|141487993|SUPERIORITY||LS Mean Difference (Net)|-7.2|||<|0.001|TWO_SIDED|95.0|-7.7|-6.8|||Mixed Models Analysis|||||-6.8|-7.7|<0.001
70989818|NCT04184622|141487993|SUPERIORITY||LS Mean Difference (Net)|-7.7|||<|0.001|TWO_SIDED|95.0|-8.2|-7.3|||Mixed Models Analysis|||||-7.3|-8.2|<0.001
70989819|NCT04184622|141487994|SUPERIORITY||LS Mean Difference (Net)|-0.33|||<|0.001|TWO_SIDED|95.0|-0.36|-0.3|||Mixed Models Analysis|||||-0.30|-0.36|<0.001
70989820|NCT04184622|141487994|SUPERIORITY||LS Mean Difference (Net)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.45|-0.38|||Mixed Models Analysis|||||-0.38|-0.45|<0.001
70989821|NCT04184622|141487994|SUPERIORITY||LS Mean Difference (Net)|-0.44|||<|0.001|TWO_SIDED|95.0|-0.48|-0.41|||Mixed Models Analysis|||||-0.41|-0.48|<0.001
70989822|NCT04184622|141487995|SUPERIORITY||LS Mean Difference (Net)|-8.59|||<|0.001|TWO_SIDED|95.0|-9.97|-7.2|||Mixed Models Analysis|||||-7.20|-9.97|<0.001
70989823|NCT04184622|141487995|SUPERIORITY||LS Mean Difference (Net)|-10.59|||<|0.001|TWO_SIDED|95.0|-11.98|-9.21|||Mixed Models Analysis|||||-9.21|-11.98|<0.001
70989824|NCT04184622|141487995|SUPERIORITY||LS Mean Difference (Net)|-11.42|||<|0.001|TWO_SIDED|95.0|-12.8|-10.3|||Mixed Models Analysis|||||-10.30|-12.80|<0.001
70989825|NCT04184622|141487996|SUPERIORITY||Estimate Difference|-6.06|||<|0.001|TWO_SIDED|95.0|-8.32|-3.75|||Mixed Models Analysis|||||-3.75|-8.32|<0.001
70989826|NCT04184622|141487997|SUPERIORITY||Estimate Difference|-23.3|||<|0.001|TWO_SIDED|95.0|-26.1|-20.4|||Mixed Models Analysis|||||-20.4|-26.1|<0.001
70989827|NCT04184622|141487998|SUPERIORITY||Estimate Difference|-11.3|||<|0.001|TWO_SIDED|95.0|-16.1|-6.2|||Mixed Models Analysis|||||-6.2|-16.1|<0.001
70989828|NCT04184622|141487999|SUPERIORITY||LS Mean Difference (Net)|-4.2|||<|0.001|TWO_SIDED|95.0|-5.0|-3.5|||Mixed Models Analysis|||||-3.5|-5.0|<0.001
70989829|NCT04184622|141488000|SUPERIORITY||Odds Ratio (OR)|29.79|||<|0.0001|TWO_SIDED|95.0|17.73|50.05|||Regression, Logistic|||||50.05|17.73|<.0001
70989830|NCT04184622|141488000|SUPERIORITY||Odds Ratio (OR)|35.05|||<|0.0001|TWO_SIDED|95.0|20.63|59.53|||Regression, Logistic|||||59.53|20.63|<.0001
70989831|NCT04184622|141488000|SUPERIORITY||Odds Ratio (OR)|55.05|||<|0.0001|TWO_SIDED|95.0|29.61|102.34|||Regression, Logistic|||||102.34|29.61|<.0001
70989832|NCT04184622|141488001|SUPERIORITY||LS Mean Difference (Net)|7.7|||<|0.001|TWO_SIDED|95.0|5.6|9.8|||ANCOVA|||||9.8|5.6|<0.001
70989833|NCT04184622|141488001|SUPERIORITY||LS Mean Difference (Net)|10.7|||<|0.001|TWO_SIDED|95.0|8.6|12.8|||ANCOVA|||||12.8|8.6|<0.001
70989834|NCT04184622|141488001|SUPERIORITY||LS Mean Difference (Net)|11.7|||<|0.001|TWO_SIDED|95.0|9.6|13.8|||ANCOVA|||||13.8|9.6|<0.001
70989835|NCT00769704|141488009|SUPERIORITY_OR_OTHER||Treatment Difference|14.1|||<|0.0001|TWO_SIDED|95.0|9.3|19.0|||Fisher Exact|||The null hypothesis was that there was no difference in the durable response rate between the talimogene laherparepvec and control arms. Study success was defined as the rejection of this hypothesis such that talimogene laherparepvec was found to be superior to GM-CSF using the 2-sided Fisher's exact test, with a p-value of ≤ 0.0488.||19.0|9.3|<0.0001
70989836|NCT00769704|141488010|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0511|TWO_SIDED|95.0|0.62|1.0|||Log Rank||The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average death rate and a longer overall survival for talimogene laherparepvec relative to GM-CSF.|The primary method for analysis of overall survival was an unadjusted log-rank test. Testing of overall survival was conditional on a statistically significance difference in the primary endpoint of durable response. Success was defined as a p-value ≤ 0.05.||1.00|0.62|0.0511
70989837|NCT00769704|141488011|SUPERIORITY_OR_OTHER||Treatment Difference|20.8|||<|0.0001|TWO_SIDED|95.0|14.4|27.1||Descriptive|Fisher Exact|||||27.1|14.4|<0.0001
70989838|NCT00769704|141488012|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||0.0868|TWO_SIDED|95.0|0.14|1.18||Descriptive|Log Rank||The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a longer average duration of response for talimogene laherparepvec relative to GM-CSF.|||1.18|0.14|0.0868
70989839|NCT00769704|141488013|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.202|TWO_SIDED|95.0|0.3|1.3||Descriptive|Log Rank||The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio \> 1.0 indicates a a higher average response onset rate for talimogene laherparepvec relative to GM-CSF.|||1.30|0.30|0.2020
70989840|NCT00769704|141488014|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.32|0.54||Descriptive|Log Rank||The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a longer average time to treatment failure for talimogene laherparepvec relative to GM-CSF.|||0.54|0.32|<0.0001
70989841|NCT00769704|141488015|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.005|TWO_SIDED|95.0|0.13|0.73||Descriptive|Log Rank||The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a longer response interval for talimogene laherparepvec relative to GM-CSF.|||0.73|0.13|0.0050
70989842|NCT01617681|141488029|OTHER||Mean Difference (Net)|-7.9|STANDARD_ERROR_OF_MEAN|2.96||0.0096|TWO_SIDED|95.0|-13.86|-2.01|||ANCOVA|||||-2.01|-13.86|0.0096
70989843|NCT01617681|141488029|OTHER||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|2.07||0.6531|TWO_SIDED|95.0|-5.07|3.2|||ANCOVA|||||3.20|-5.07|0.6531
70989844|NCT01617681|141488030|OTHER||Mean Difference (Net)|-7.9|STANDARD_ERROR_OF_MEAN|2.54||0.003|TWO_SIDED|95.0|-12.94|-2.78|||ANCOVA|||||-2.78|-12.94|0.0030
70989845|NCT01617681|141488030|OTHER||Mean Difference (Net)|-5.4|STANDARD_ERROR_OF_MEAN|1.8||0.0042|TWO_SIDED|95.0|-8.98|-1.77|||ANCOVA|||||-1.77|-8.98|0.0042
70989846|NCT01617681|141488031|OTHER||Odds Ratio (OR)|1.68||||0.411|TWO_SIDED|95.0|0.49|5.8|||ANCOVA|||||5.8|0.49|0.411
70989847|NCT01617681|141488031|OTHER||Odds Ratio (OR)|1.45||||0.5443|TWO_SIDED|95.0|0.44|4.79|||ANCOVA|||||4.79|0.44|0.5443
70989848|NCT01617681|141488032|OTHER||Odds Ratio (OR)|0.517||||0.2624|TWO_SIDED|95.0|0.16|1.64|||ANCOVA|||||1.64|0.16|0.2624
70989849|NCT01883440|141488047|SUPERIORITY_OR_OTHER||||||<|0.037|TWO_SIDED||||||Mixed Models Analysis|Linear mixed model||||||<0.037
70989850|NCT01883440|141488048|SUPERIORITY_OR_OTHER|||||||0.381|TWO_SIDED||||||Mixed Models Analysis|||In the material when all were included, there were a lot of persons with few symptoms in both Groups, which means that a larger study would be needed in order to detect significant differences.||||0.381
70989851|NCT03696758|141488049|OTHER|Descriptive statistics||||||0.004||||||p value is 0.004 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.004
70989852|NCT03696758|141488050|OTHER|Descriptive statistics||||||0.13||||||P-Value is 0.13 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.13
70989853|NCT03696758|141488051|OTHER|descriptive statistics||||||0.004||||||p value is 0.004 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.004
70989854|NCT03696758|141488052|OTHER|Descriptive statistics||||||0.1||||||p value is 0.10 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.1
70989855|NCT03696758|141488053|OTHER|Descriptive statistics||||||0.09||||||p value is 0.09 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.09
70989856|NCT03696758|141488054|OTHER|Descriptive statistics||||||0.1||||||p value is 0.10 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.10
70989857|NCT03696758|141488055|OTHER|Descriptive statistics||||||0.82||||||p value is 0.82 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.82
70989858|NCT03696758|141488056|OTHER|Descriptive statistics||||||0.3||||||p value is 0.30 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.30
70989859|NCT03696758|141488057|OTHER|Descriptive statistics||||||0.36||||||p value is 0.36 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.36
70989860|NCT03696758|141488058|OTHER|Descriptive statistics||||||0.36||||||p value is 0.36 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.36
70989861|NCT03696758|141488059|OTHER|Descriptive statistics||||||0.65||||||P-Value is 0.65 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.65
70989862|NCT03696758|141488060|OTHER|Descriptive statistics||||||0.25||||||P-Value is 0.25 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.25
70989863|NCT03696758|141488061|OTHER|Descriptive statistics||||||0.43||||||P-Value is 0.43 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.43
70989864|NCT03696758|141488062|OTHER|Descriptive statistics||||||0.66||||||P-Value is 0.66 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.66
70989865|NCT03696758|141488063|OTHER|Descriptive statistics||||||0.13||||||P-Value is 0.13 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.13
70989866|NCT03696758|141488064|OTHER|Descriptive statistics||||||0.57||||||P-Value is 0.57 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.57
70989867|NCT03696758|141488065|OTHER|Descriptive statistics||||||0.25||||||P-Value is 0.25 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.25
70989868|NCT03696758|141488066|OTHER|Descriptive statistics||||||0.07||||||P-Value is 0.07 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.07
70989869|NCT03696758|141488067|OTHER|Descriptive statistics||||||0.36||||||P-Value is 0.36 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.36
70989870|NCT03696758|141488068|OTHER|Descriptive statistics||||||0.91||||||P-Value is 0.91 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.91
70989871|NCT01856595|141488109|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-2.77|STANDARD_ERROR_OF_MEAN|8.532||0.7457|TWO_SIDED|90.0|-16.93|11.38||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||11.38|-16.93|0.7457
70989872|NCT01856595|141488109|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-21.64|STANDARD_ERROR_OF_MEAN|8.334||0.0108|TWO_SIDED|90.0|-35.47|-7.81||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||-7.81|-35.47|0.0108
70989873|NCT01856595|141488109|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-26.59|STANDARD_ERROR_OF_MEAN|8.309||0.0018|TWO_SIDED|90.0|-40.38|-12.8||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||-12.80|-40.38|0.0018
70989874|NCT01856595|141488109|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-32.33|STANDARD_ERROR_OF_MEAN|8.038||0.0001|TWO_SIDED|90.0|-45.66|-18.99||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||-18.99|-45.66|0.0001
70989875|NCT01856595|141488109|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-42.39|STANDARD_ERROR_OF_MEAN|8.34|<|0.0001|TWO_SIDED|90.0|-56.23|-28.55||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||-28.55|-56.23|<0.0001
70989876|NCT01856595|141488110|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|10.47|STANDARD_ERROR_OF_MEAN|9.621||0.279|TWO_SIDED|90.0|-5.5|26.43||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||26.43|-5.50|0.2790
70989877|NCT01856595|141488110|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-19.33|STANDARD_ERROR_OF_MEAN|8.777||0.0299||90.0|-33.89|-4.76||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||-4.76|-33.89|0.0299
70989878|NCT01856595|141488111|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-29.43|STANDARD_ERROR_OF_MEAN|7.609||0.0005|TWO_SIDED|90.0|-42.28|-16.57||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||-16.57|-42.28|0.0005
70989879|NCT01856595|141488111|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-11.89|STANDARD_ERROR_OF_MEAN|7.321||0.1133|TWO_SIDED|90.0|-24.26|0.48||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.48|-24.26|0.1133
70989880|NCT01856595|141488112|SUPERIORITY_OR_OTHER||Ratio|0.99|STANDARD_ERROR_OF_MEAN|1.066||0.853|TWO_SIDED|90.0|0.89|1.1||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.10|0.89|0.8530
70989881|NCT01856595|141488112|SUPERIORITY_OR_OTHER||Ratio|0.86|STANDARD_ERROR_OF_MEAN|1.065||0.0172|TWO_SIDED|90.0|0.77|0.95||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.95|0.77|0.0172
70989882|NCT01856595|141488112|SUPERIORITY_OR_OTHER||Ratio|0.85|STANDARD_ERROR_OF_MEAN|1.064||0.0106|TWO_SIDED|90.0|0.77|0.94||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.94|0.77|0.0106
70989883|NCT01856595|141488112|SUPERIORITY_OR_OTHER||Ratio|0.82|STANDARD_ERROR_OF_MEAN|1.062||0.0012|TWO_SIDED|90.0|0.74|0.9||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.90|0.74|0.0012
70989884|NCT01856595|141488112|SUPERIORITY_OR_OTHER||Ratio|0.77|STANDARD_ERROR_OF_MEAN|1.065|<|0.0001|TWO_SIDED|90.0|0.69|0.85||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.85|0.69|<0.0001
70989885|NCT01856595|141488113|SUPERIORITY_OR_OTHER||Ratio|0.98|STANDARD_ERROR_OF_MEAN|1.075||0.7804|TWO_SIDED|90.0|0.87|1.1||Two-sided p-values are from analysis of ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.10|0.87|0.7804
70989886|NCT01856595|141488113|SUPERIORITY_OR_OTHER||Ratio|0.88|STANDARD_ERROR_OF_MEAN|1.068||0.0908|TWO_SIDED|90.0|0.77|1.0||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.00|0.77|0.0908
70989887|NCT01856595|141488114|SUPERIORITY_OR_OTHER||Ratio|0.77|STANDARD_ERROR_OF_MEAN|1.083||0.0027|TWO_SIDED|90.0|0.68|0.88||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.88|0.68|0.0027
70989888|NCT01856595|141488114|SUPERIORITY_OR_OTHER||Ratio|0.88|STANDARD_ERROR_OF_MEAN|1.079||0.0908|TWO_SIDED|90.0|0.77|1.0||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.00|0.77|0.0908
70989889|NCT01856595|141488118|SUPERIORITY_OR_OTHER||Ratio|0.98|STANDARD_ERROR_OF_MEAN|1.123||0.8723|TWO_SIDED|90.0|0.81|1.19||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.19|0.81|0.8723
70989890|NCT01856595|141488118|SUPERIORITY_OR_OTHER||Ratio|0.93|STANDARD_ERROR_OF_MEAN|1.124||0.5158|TWO_SIDED|90.0|0.76|1.13||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.13|0.76|0.5158
70989891|NCT01856595|141488118|SUPERIORITY_OR_OTHER||Ratio|0.83|STANDARD_ERROR_OF_MEAN|1.126||0.1258|TWO_SIDED|90.0|0.68|1.01||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.01|0.68|0.1258
70989892|NCT01856595|141488118|SUPERIORITY_OR_OTHER||Ratio|0.89|STANDARD_ERROR_OF_MEAN|1.115||0.2883|TWO_SIDED|90.0|0.74|1.07||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.07|0.74|0.2883
70989893|NCT01856595|141488118|SUPERIORITY_OR_OTHER||Ratio|0.98|STANDARD_ERROR_OF_MEAN|1.12||0.8437|TWO_SIDED|90.0|0.81|1.18||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.18|0.81|0.8437
70989894|NCT01856595|141488119|SUPERIORITY_OR_OTHER||Ratio|1.12|STANDARD_ERROR_OF_MEAN|1.154||0.4405|TWO_SIDED|90.0|0.88|1.42||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.42|0.88|0.4405
70989895|NCT01856595|141488119|SUPERIORITY_OR_OTHER||Ratio|1.09|STANDARD_ERROR_OF_MEAN|1.146||0.5178|TWO_SIDED|90.0|0.87|1.37||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.37|0.87|0.5178
70989896|NCT01856595|141488120|SUPERIORITY_OR_OTHER||Ratio|0.69|STANDARD_ERROR_OF_MEAN|1.181||0.034|TWO_SIDED|90.0|0.52|0.92||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.92|0.52|0.0340
70989897|NCT01856595|141488120|SUPERIORITY_OR_OTHER||Ratio|1.2|STANDARD_ERROR_OF_MEAN|1.173||0.2519|TWO_SIDED|90.0|0.92|1.58||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.58|0.92|0.2519
70989898|NCT01856595|141488121|SUPERIORITY_OR_OTHER||Ratio|1.06|STANDARD_ERROR_OF_MEAN|1.079||0.4579|TWO_SIDED|90.0|0.93|1.2||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.20|0.93|0.4579
70989899|NCT01856595|141488121|SUPERIORITY_OR_OTHER||Ratio|0.98|STANDARD_ERROR_OF_MEAN|1.079||0.8144|TWO_SIDED|90.0|0.87|1.11||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.11|0.87|0.8144
70989900|NCT01856595|141488121|SUPERIORITY_OR_OTHER||Ratio|0.93|STANDARD_ERROR_OF_MEAN|1.082||0.3425|TWO_SIDED|90.0|0.81|1.06||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.06|0.81|0.3425
70989901|NCT01856595|141488121|SUPERIORITY_OR_OTHER||Ratio|1.0|STANDARD_ERROR_OF_MEAN|1.076||0.967|TWO_SIDED|90.0|0.88|1.13||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.13|0.88|0.9670
70989902|NCT01856595|141488121|SUPERIORITY_OR_OTHER||Ratio|1.08|STANDARD_ERROR_OF_MEAN|1.079||0.319|TWO_SIDED|90.0|0.95|1.23||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.23|0.95|0.3190
70989903|NCT01856595|141488122|SUPERIORITY_OR_OTHER||Ratio|1.14|STANDARD_ERROR_OF_MEAN|1.095||0.1617|TWO_SIDED|90.0|0.98|1.32||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.32|0.98|0.1617
70989904|NCT01856595|141488122|SUPERIORITY_OR_OTHER||Ratio|1.08|STANDARD_ERROR_OF_MEAN|1.084||0.3703|TWO_SIDED|90.0|0.94|1.23||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.23|0.94|0.3703
70989905|NCT01856595|141488123|SUPERIORITY_OR_OTHER||Ratio|0.95|STANDARD_ERROR_OF_MEAN|1.119||0.6833|TWO_SIDED|90.0|0.79|1.15||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.15|0.79|0.6833
70989906|NCT01856595|141488123|SUPERIORITY_OR_OTHER||Ratio|1.18|STANDARD_ERROR_OF_MEAN|1.112||0.1318|TWO_SIDED|90.0|0.98|1.41||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.41|0.98|0.1318
70989907|NCT04346628|141488148|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.24|TWO_SIDED|95.0|0.48|1.2||The final test was performed at the alpha = 0.04999 level of significance, adjusted for age group and sex.|Cox proportional hazards model||Hazard ratio adjusted for age and sex|||1.20|0.48|0.24
71038977|NCT01874535|141585597|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.009|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
70989908|NCT04346628|141488150|SUPERIORITY|||||||0.06||||||A p-value of 0.05 would have been considered statistically significant.|Fisher Exact|||Difference in hospitalizations||||0.06
70989909|NCT04346628|141488150|SUPERIORITY|||||||0.56||||||A p-value of 0.05 would have been considered statistically significant.|Fisher Exact|||Difference in ED visits||||0.56
70989910|NCT04346628|141488152|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.43|TWO_SIDED|95.0|0.54|1.29||A p-value of 0.05 would have been considered statistically significant.|Cox proportional hazards model||Hazard ratio adjusted for age and sex|Difference in days until initial resolution of symptoms||1.29|0.54|0.43
70989911|NCT04346628|141488152|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.59|TWO_SIDED|95.0|0.52|1.45||A p-value of 0.05 would have been considered statistically significant.|Cox proportional hazards model||Hazard ratio adjusted for age and sex|Difference in days until sustained resolution of symptoms||1.45|0.52|0.59
70989912|NCT01763905|141488156|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.06|STANDARD_ERROR_OF_MEAN|2.87|<|0.001|TWO_SIDED|95.0|-43.73|-32.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||The null hypothesis was that there is no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis is that a mean difference does exist.||-32.99|-43.73|<0.001
70989913|NCT01763905|141488156|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.55|STANDARD_ERROR_OF_MEAN|2.33|<|0.001|TWO_SIDED|95.0|-42.16|-32.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||The null hypothesis was that there is no mean difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis is that a mean difference does exist.||-32.94|-42.16|<0.001
70989914|NCT01763905|141488157|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-66.3|STANDARD_ERROR_OF_MEAN|5.9|<|0.001|TWO_SIDED|95.0|-77.9|-54.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-54.7|-77.9|<0.001
71038978|NCT02597049|141585598|SUPERIORITY||Mean Difference (Final Values)|-0.79|||<|0.001|TWO_SIDED|95.0|-0.97|-0.61|||Mixed Models Analysis|||||-0.61|-0.97|<.001
71038979|NCT02597049|141585598|SUPERIORITY||Mean Difference (Final Values)|-0.66|||<|0.001|TWO_SIDED|95.0|-0.84|-0.49|||Mixed Models Analysis|||||-0.49|-0.84|< .001
71038980|NCT02597049|141585599|SUPERIORITY||Mean Difference (Final Values)|-0.82|||<|0.001|TWO_SIDED|95.0|-1.0|-0.64|||Mixed Models Analysis|||||-0.64|-1.00|<.001
71038981|NCT02597049|141585599|SUPERIORITY||Mean Difference (Final Values)|-0.69|||<|0.001|TWO_SIDED|95.0|-0.86|-0.51|||Mixed Models Analysis|||||-0.51|-0.86|<.001
71038982|NCT02597049|141585600|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||Treatment-regimen Estimand||||< .001
70989915|NCT01763905|141488157|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-70.6|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-80.5|-60.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-60.7|-80.5|<0.001
70989916|NCT01763905|141488158|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-69.7|STANDARD_ERROR_OF_MEAN|6.2|<|0.001|TWO_SIDED|95.0|-82.0|-57.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-57.5|-82.0|<0.001
70989917|NCT01763905|141488158|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-68.8|STANDARD_ERROR_OF_MEAN|5.3|<|0.001|TWO_SIDED|95.0|-79.2|-58.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-58.4|-79.2|<0.001
70989918|NCT01763905|141488159|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|43.5|||<|0.001|TWO_SIDED|95.0|30.9|53.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and statin use. For testing, non-achievement was imputed for participants with missing data.||||53.4|30.9|<0.001
70989919|NCT01763905|141488159|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|42.0|||<|0.001|TWO_SIDED|95.0|30.3|51.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and statin use. For testing, non-achievement was imputed for participants with missing data.||||51.8|30.3|<0.001
70989920|NCT01763905|141488160|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|48.0|||<|0.001|TWO_SIDED|95.0|35.0|57.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and statin use. For testing, non-achievement was imputed for participants with missing data.||||57.8|35.0|<0.001
70989921|NCT01763905|141488160|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|37.5|||<|0.001|TWO_SIDED|95.0|25.5|47.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and statin use. For testing, non-achievement was imputed for participants with missing data.||||47.5|25.5|<0.001
70989922|NCT01763905|141488161|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.53|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-36.34|-26.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-26.73|-36.34|<0.001
70989923|NCT01763905|141488161|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.58|STANDARD_ERROR_OF_MEAN|2.05|<|0.001|TWO_SIDED|95.0|-38.63|-30.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-30.54|-38.63|<0.001
70989924|NCT01763905|141488162|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.09|STANDARD_ERROR_OF_MEAN|2.63|<|0.001|TWO_SIDED|95.0|-37.28|-26.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-26.90|-37.28|<0.001
70989925|NCT01763905|141488162|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.99|STANDARD_ERROR_OF_MEAN|2.12|<|0.001|TWO_SIDED|95.0|-37.19|-28.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-28.79|-37.19|<0.001
70989926|NCT01763905|141488163|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.2|STANDARD_ERROR_OF_MEAN|2.39|<|0.001|TWO_SIDED|95.0|-36.92|-27.49||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-27.49|-36.92|<0.001
70989927|NCT01763905|141488163|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.99|STANDARD_ERROR_OF_MEAN|2.33|<|0.001|TWO_SIDED|95.0|-39.59|-30.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-30.39|-39.59|<0.001
70989928|NCT01763905|141488164|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.86|STANDARD_ERROR_OF_MEAN|2.62|<|0.001|TWO_SIDED|95.0|-38.04|-27.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-27.68|-38.04|<0.001
70989929|NCT01763905|141488164|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.1|STANDARD_ERROR_OF_MEAN|2.5|<|0.001|TWO_SIDED|95.0|-38.04|-28.17||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-28.17|-38.04|<0.001
70989930|NCT01763905|141488165|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.39|STANDARD_ERROR_OF_MEAN|2.39|<|0.001|TWO_SIDED|95.0|-32.11|-22.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-22.67|-32.11|<0.001
71038983|NCT02597049|141585600|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||Treatment-regimen Estimand||||< .001
71038984|NCT02597049|141585600|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||Efficacy Estimand||||< .001
70989931|NCT01763905|141488165|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-29.94|STANDARD_ERROR_OF_MEAN|2.42|<|0.001|TWO_SIDED|95.0|-34.72|-25.17||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-25.17|-34.72|<0.001
70989932|NCT01763905|141488166|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.28|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-31.42|-21.15||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-21.15|-31.42|<0.001
70989933|NCT01763905|141488166|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.66|STANDARD_ERROR_OF_MEAN|2.64|<|0.001|TWO_SIDED|95.0|-33.88|-23.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-23.43|-33.88|<0.001
70989934|NCT01763905|141488167|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.86|STANDARD_ERROR_OF_MEAN|2.52|<|0.001|TWO_SIDED|95.0|-39.84|-29.88||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-29.88|-39.84|<0.001
70989935|NCT01763905|141488167|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.37|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED|95.0|-41.73|-31.01||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-31.01|-41.73|<0.001
70989936|NCT01763905|141488168|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.53|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-40.05|-29.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-29.00|-40.05|<0.001
70989937|NCT01763905|141488168|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.13|STANDARD_ERROR_OF_MEAN|2.91|<|0.001|TWO_SIDED|95.0|-39.87|-28.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-28.39|-39.87|<0.001
70989938|NCT01763905|141488169|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-23.9|STANDARD_ERROR_OF_MEAN|3.73|<|0.001|TWO_SIDED|95.0|-31.27|-16.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-16.54|-31.27|<0.001
70989939|NCT01763905|141488169|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.26|STANDARD_ERROR_OF_MEAN|4.3|<|0.001|TWO_SIDED|95.0|-33.75|-16.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-16.77|-33.75|<0.001
70989940|NCT01763905|141488170|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.29|STANDARD_ERROR_OF_MEAN|4.03|<|0.001|TWO_SIDED|95.0|-33.26|-17.33||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-17.33|-33.26|<0.001
70989941|NCT01763905|141488170|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.88|STANDARD_ERROR_OF_MEAN|5.73|<|0.001|TWO_SIDED|95.0|-39.21|-16.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-16.56|-39.21|<0.001
70989942|NCT01763905|141488171|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-2.59|STANDARD_ERROR_OF_MEAN|4.45||0.97|TWO_SIDED|95.0|-11.38|6.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||6.20|-11.38|0.97
70989943|NCT01763905|141488171|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-6.42|STANDARD_ERROR_OF_MEAN|5.13||0.33|TWO_SIDED|95.0|-16.55|3.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||3.71|-16.55|0.33
70989944|NCT01763905|141488172|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|1.58|STANDARD_ERROR_OF_MEAN|4.92||0.97|TWO_SIDED|95.0|-8.14|11.31||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||11.31|-8.14|0.97
70989945|NCT01763905|141488172|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-4.69|STANDARD_ERROR_OF_MEAN|6.25||0.33|TWO_SIDED|95.0|-17.04|7.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||7.67|-17.04|0.33
71038985|NCT02597049|141585600|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||Efficacy Estimand||||< .001
71038986|NCT02597049|141585601|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.027|TWO_SIDED|95.0|-1.8|-0.1|||Mixed Models Analysis|||Treatment-regimen Estimand||-0.1|-1.8|0.027
71038987|NCT02597049|141585601|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.264|TWO_SIDED|95.0|-1.3|0.4|||Mixed Models Analysis|||Treatment-regimen Estimand||0.4|-1.3|0.264
70989946|NCT01763905|141488173|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|5.15|STANDARD_ERROR_OF_MEAN|2.23||0.068|TWO_SIDED|95.0|0.74|9.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||9.56|0.74|0.068
70989947|NCT01763905|141488173|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|5.74|STANDARD_ERROR_OF_MEAN|2.28||0.13|TWO_SIDED|95.0|1.23|10.24||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||10.24|1.23|0.13
70989948|NCT01763905|141488174|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|3.57|STANDARD_ERROR_OF_MEAN|2.56||0.068|TWO_SIDED|95.0|-1.49|8.63||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||8.63|-1.49|0.068
70989949|NCT01763905|141488174|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|4.83|STANDARD_ERROR_OF_MEAN|2.52||0.13|TWO_SIDED|95.0|-0.16|9.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||9.81|-0.16|0.13
70989950|NCT01763905|141488175|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-1.84|STANDARD_ERROR_OF_MEAN|4.35||0.97|TWO_SIDED|95.0|-10.43|6.75||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||6.75|-10.43|0.97
70989951|NCT01763905|141488175|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-3.53|STANDARD_ERROR_OF_MEAN|4.85||0.33|TWO_SIDED|95.0|-13.12|6.06||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||6.06|-13.12|0.33
70989952|NCT01763905|141488176|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-0.67|STANDARD_ERROR_OF_MEAN|4.7||0.97|TWO_SIDED|95.0|-9.96|8.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||8.61|-9.96|0.97
70989953|NCT01763905|141488176|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|0.08|STANDARD_ERROR_OF_MEAN|5.72||0.33|TWO_SIDED|95.0|-11.24|11.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||11.39|-11.24|0.33
71038988|NCT02597049|141585601|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.059|TWO_SIDED|95.0|-1.7|0.0|||Mixed Models Analysis|||Efficacy Estimand||0.0|-1.7|0.059
71038989|NCT02597049|141585601|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.435|TWO_SIDED|95.0|-1.2|0.5|||Mixed Models Analysis|||Efficacy Estimand||0.5|-1.2|0.435
70989954|NCT01763905|141488177|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.9|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED|95.0|-42.26|-31.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||The null hypothesis was that there is no mean difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis is that a mean difference does exist.||-31.55|-42.26|<0.001
70989955|NCT01763905|141488177|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.69|STANDARD_ERROR_OF_MEAN|2.21|<|0.001|TWO_SIDED|95.0|-43.06|-34.22||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||The null hypothesis was that there is no mean difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis is that a mean difference does exist.||-34.22|-43.06|<0.001
71038990|NCT02597049|141585602|SUPERIORITY||Mean Difference (Final Values)|-24.7|||<|0.001|TWO_SIDED|95.0|-30.8|-18.6|||ANCOVA|||Treatment-regimen Estimand||-18.6|-30.8|< .001
70989956|NCT00578864|141488194|SUPERIORITY_OR_OTHER_LEGACY|||||||0.367||95.0|||||Fisher Exact|||||||0.367
70989957|NCT00578864|141488197|SUPERIORITY_OR_OTHER_LEGACY|||||||0.592||95.0|||||Fisher Exact|||||||0.592
71038991|NCT02597049|141585602|SUPERIORITY||Mean Difference (Final Values)|-19.6|||<|0.001|TWO_SIDED|95.0|-25.7|-13.5||Test was not controlled for type I error.|ANCOVA|||Treatment-regimen Estimand||-13.5|-25.7|<0.001
71038992|NCT02597049|141585602|SUPERIORITY||Mean Difference (Final Values)|-26.6|||<|0.001|TWO_SIDED|95.0|-32.7|-20.6||Test was not controlled for type I error.|ANCOVA|||Efficacy Estimand||-20.6|-32.7|<0.001
71038993|NCT02597049|141585602|SUPERIORITY||Mean Difference (Final Values)|-20.7|||<|0.001|TWO_SIDED|95.0|-26.7|-14.6||Test was not controlled for type I error.|ANCOVA|||Efficacy Estimand||-14.6|-26.7|<0.001
71038994|NCT02597049|141585603|SUPERIORITY||Mean Difference (Final Values)|-19.7|||<|0.001|TWO_SIDED|95.0|-25.7|-13.8|||Mixed Models Analysis|||Pre-morning meal.||-13.8|-25.7|< .001
71038995|NCT02597049|141585603|SUPERIORITY||Mean Difference (Final Values)|-15.2|||<|0.001|TWO_SIDED|95.0|-21.2|-9.2|||Mixed Models Analysis|||Pre-morning meal||-9.2|-21.2|< .001
71038996|NCT02597049|141585603|SUPERIORITY||Mean Difference (Final Values)|-24.5|||<|0.001|TWO_SIDED|95.0|-33.8|-15.3|||Mixed Models Analysis|||2-hour postprandial||-15.3|-33.8|< .001
71038997|NCT02597049|141585603|SUPERIORITY||Mean Difference (Final Values)|-21.1|||<|0.001|TWO_SIDED|95.0|-30.3|-11.8|||Mixed Models Analysis|||2-hour postprandial||-11.8|-30.3|< .001
71038998|NCT02597049|141585603|SUPERIORITY||Mean Difference (Final Values)|-18.3|||<|0.001|TWO_SIDED|95.0|-26.4|-10.2|||Mixed Models Analysis|||Pre-midday meal||-10.2|-26.4|< .001
70989958|NCT00962000|141488216|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size required for the study was estimated using a web-based power calculation tool. Analysis of data from some 50,000 hemodialysis patients showed a within-patient between-treatment standard deviation of 0.21 for Kt/Vurea. Using this estimate of standard deviation, 38 subjects would be needed to detect a difference in Kt/Vurea of 0.1 with a significance level of 0.05 and a power of 90% with two determinations per subject at each level of dialysate flow rate.|Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|0.02217|||TWO_SIDED|95.0|-0.064|0.024||There is no p values because the power calculation is based on the primary outcome variable|ANOVA|The three centers and the two flow rates were treated as fixed effects and the subjects within centers modeled as a random effect.||Increasing the dialysate flow rates from 600 mL/min to 800 mL/min will not significantly increase Kt/Vurea.||0.024|-0.064|
70989959|NCT00962000|141488217|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size required for the study was estimated using a web-based power calculation tool. Analysis of data from some 50,000 hemodialysis patients showed a within-patient between-treatment standard deviation of 0.21 for Kt/Vurea. Using this estimate of standard deviation, 38 subjects would be needed to detect a difference in Kt/Vurea of 0.1 with a significance level of 0.05 and a power of 90% with two determinations per subject at each level of dialysate flow rate.|Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.01849|||TWO_SIDED|95.0|-0.051|0.023||There is no p value for eKt/V because the power calculation is based on the primary outcome variable (Kt/Vsp) alone.|ANOVA|The three centers and the two flow rates were treated as fixed effects and the subjects within centers modeled as a random effect.||Increasing the dialysate flow rates from 600 mL/min to 800 mL/min will not significantly increase Kt/Vurea.||0.023|-0.051|
70989960|NCT00962000|141488218|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size required for the study was estimated using a web-based power calculation tool. Analysis of data from some 50,000 hemodialysis patients showed a within-patient between-treatment standard deviation of 0.21 for Kt/Vurea. Using this estimate of standard deviation, 38 subjects would be needed to detect a difference in Kt/Vurea of 0.1 with a significance level of 0.05 and a power of 90% with two determinations per subject at each level of dialysate flow rate.|Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.03103||||95.0|-0.029|0.099||There is no p value for Kt/VID because the power calculation is based on the primary outcome variable (Kt/Vsp) alone.|ANOVA|||Increasing the dialysate flow rates from 600 mL/min to 800 mL/min will not significantly increase Kt/Vurea.||0.099|-0.029|
70989961|NCT02702193|141488219|SUPERIORITY||Slope|-0.24|STANDARD_ERROR_OF_MEAN|0.11|<|0.05|TWO_SIDED|95.0|||||Generalized Estimating Equations (GEE)|GEE allowed the examination of trajectories from baseline through the 12 month follow-up.||To determine sample size for the grant proposal we conducted simulation studies in Mplus (Muthén \& Muthén, 2010) following the procedure described by Muthén and Muthén (2002). Each simulation created 10,000 datasets, assuming a medium-size (d = .5) intervention effect, and attrition of 10% at each assessment. For α= .05, the power estimate was at or above 80% with a sample of 172 mothers.||||<.05
70989962|NCT01201798|141488230|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority margin was 0.5 units, meaning that the upper limit of the two-tailed 95% confidence interval must have been less than 0.5 to establish noninferiority.|Mean Difference (Net)|-0.22|||||TWO_SIDED|95.0|-0.53|0.09|||ANCOVA|||A two-tailed 95% confidence interval was calculated for the difference in change from baseline in anterior chamber cell grade at Day 14 (difluprednate minus prednisolone). The confidence interval was derived from an analysis of covariance (ANCOVA), with investigative site included as a fixed effect to match the stratification used in the randomization process. Treatment and baseline anterior chamber cell grade were also included as fixed effects.||0.09|-0.53|
70989963|NCT00829166|141488291|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.549|0.771|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or greater than \[\>\] 1), and visceral/ non-visceral disease.||0.771|0.549|<0.0001
70989964|NCT00829166|141488293|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.682||||0.0006|TWO_SIDED|95.0|0.548|0.849|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \>1), and visceral/ non-visceral disease.||0.849|0.548|0.0006
70989965|NCT00829166|141488295|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.749||||0.0003|TWO_SIDED|95.0|0.639|0.877|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \>1), and visceral/ non-visceral disease.||0.877|0.639|0.0003
70989966|NCT00829166|141488299|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.658|||<|0.0001|TWO_SIDED|95.0|0.56|0.774|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \>1), and visceral/ non-visceral disease.||0.774|0.560|<0.0001
70989967|NCT00829166|141488300|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|12.7||||0.0002|TWO_SIDED|95.0|6.0|19.4|||Mantel-Haenszel chi-squared test||The 95% CI for the difference in objective response rate (Trastuzumab emtansine minus Lapatinib + Capecitabine) was computed by using the approximate normal method.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \>1), and visceral/ non-visceral disease.||19.4|6.0|0.0002
70989968|NCT00829166|141488302|SUPERIORITY_OR_OTHER||Difference in Clinical Benefit Rate|14.0|||||TWO_SIDED|95.0|7.0|20.9|||||The 95% CI for the difference in clinical benefit rate (Trastuzumab emtansine minus Lapatinib + Capecitabine) was computed by using the normal approximation method.|||20.9|7.0|
70989969|NCT00829166|141488304|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.703|||<|0.0001|TWO_SIDED|95.0|0.602|0.82|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \>1), and visceral/ non-visceral disease.||0.820|0.602|<0.0001
70989970|NCT00829166|141488306|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.796||||0.0121|TWO_SIDED|95.0|0.667|0.951|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \>1), and visceral/ non-visceral disease.||0.951|0.667|0.0121
71038999|NCT02597049|141585603|SUPERIORITY||Mean Difference (Final Values)|-14.3|||<|0.001|TWO_SIDED|95.0|-22.5|-6.2|||Mixed Models Analysis|||Pre-midday meal||-6.2|-22.5|< .001
71039000|NCT02597049|141585603|SUPERIORITY||Mean Difference (Final Values)|-19.0|||<|0.001|TWO_SIDED|95.0|-28.8|-9.3|||Mixed Models Analysis|||2-hour postprandial after midday meal||-9.3|-28.8|< .001
70989971|NCT04590937|141488307|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|98.22|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|90.0|94.89|101.67|||||The geometric means ratio was calculated as Metformin + BI 730357 / Metformin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||101.67|94.89|
70989972|NCT04590937|141488308|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|123.08|STANDARD_ERROR_OF_MEAN|12.7|||TWO_SIDED|90.0|112.22|134.98|||||The geometric means ratio was calculated as Rosuvastatin + BI 730357 / Rosuvastatin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||134.98|112.22|
70989973|NCT04590937|141488309|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|117.72|STANDARD_ERROR_OF_MEAN|9.0|||TWO_SIDED|90.0|110.57|125.34|||||The geometric means ratio was calculated as Furosemide + BI 730357 / Furosemide. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||125.34|110.57|
70989974|NCT04590937|141488310|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|170.29|STANDARD_ERROR_OF_MEAN|25.6|||TWO_SIDED|90.0|143.73|201.76|||||The geometric means ratio was calculated as Digoxin + BI 730357 / Digoxin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||201.76|143.73|
70989975|NCT04590937|141488311|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|91.42|STANDARD_ERROR_OF_MEAN|5.6|||TWO_SIDED|90.0|88.04|94.93|||||The geometric means ratio was calculated as Metformin + BI 730357 / Metformin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||94.93|88.04|
70989976|NCT04590937|141488312|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|139.03|STANDARD_ERROR_OF_MEAN|16.9|||TWO_SIDED|90.0|124.29|155.51|||||The geometric means ratio was calculated as Rosuvastatin + BI 730357 / Rosuvastatin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||155.51|124.29|
70989977|NCT04590937|141488313|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|112.1|STANDARD_ERROR_OF_MEAN|15.4|||TWO_SIDED|90.0|101.26|124.11|||||The geometric means ratio was calculated as Furosemide + BI 730357 / Furosemide. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||124.11|101.26|
70989978|NCT04590937|141488314|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|161.29|STANDARD_ERROR_OF_MEAN|34.1|||TWO_SIDED|90.0|129.17|201.39|||||The geometric means ratio was calculated as Digoxin + BI 730357 / Digoxin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||201.39|129.17|
70989979|NCT04590937|141488315|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|98.23|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|90.0|94.86|101.73|||||The geometric means ratio was calculated as Metformin + BI 730357 / Metformin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||101.73|94.86|
70989980|NCT04590937|141488316|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|118.67|STANDARD_ERROR_OF_MEAN|13.0|||TWO_SIDED|90.0|108.83|129.4|||||The geometric means ratio was calculated as Rosuvastatin + BI 730357 / Rosuvastatin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||129.40|108.83|
70989981|NCT04590937|141488317|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|114.07|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|90.0|107.93|120.56|||||The geometric means ratio was calculated as Furosemide + BI 730357 / Furosemide. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||120.56|107.93|
70989982|NCT04590937|141488318|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|173.77|STANDARD_ERROR_OF_MEAN|30.8|||TWO_SIDED|90.0|141.9|212.8|||||The geometric means ratio was calculated as Digoxin + BI 730357 / Digoxin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||212.80|141.90|
70989983|NCT04525222|141488322|OTHER||Slope|0.42||||0.0088|TWO_SIDED|95.0|0.1|0.74|||Regression, Linear|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||"Treatment satisfaction items are reported on a Likert-type scale, with response choices ranging from not at all to very much. We used a linear regression adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), and Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5) to test for differences between arms."||0.74|0.10|0.0088
71039001|NCT02597049|141585603|SUPERIORITY||Mean Difference (Final Values)|-12.8||||0.01|TWO_SIDED|95.0|-22.5|-3.1|||Mixed Models Analysis|||2-hour postprandial after midday meal||-3.1|-22.5|0.010
71039002|NCT02597049|141585603|SUPERIORITY||Mean Difference (Final Values)|-22.7|||<|0.001|TWO_SIDED|95.0|-30.7|-14.7|||Mixed Models Analysis|||Pre-evening meal||-14.7|-30.7|< .001
71039003|NCT02597049|141585603|SUPERIORITY||Mean Difference (Final Values)|-22.5|||<|0.001|TWO_SIDED|95.0|-30.7|-14.4|||Mixed Models Analysis|||Pre-evening meal||-14.4|-30.7|< .001
71039004|NCT02597049|141585603|SUPERIORITY||Mean Difference (Final Values)|-22.1|||<|0.001|TWO_SIDED|95.0|-31.4|-12.9|||Mixed Models Analysis|||2-hour postprandial after evening meal||-12.9|-31.4|< .001
71039005|NCT02597049|141585603|SUPERIORITY||Mean Difference (Final Values)|-16.7|||<|0.001|TWO_SIDED|95.0|-26.0|-7.4|||Mixed Models Analysis|||2-hour postprandial after evening meal||-7.4|-26.0|< .001
71039006|NCT02597049|141585604|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.032|TWO_SIDED|95.0|-2.3|-0.1|||ANCOVA|||Treatment-regimen Estimand||-0.1|-2.3|0.032
71039007|NCT02597049|141585604|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.273|TWO_SIDED|95.0|-1.7|0.5|||ANCOVA|||Treatment-regimen Estimand||0.5|-1.7|0.273
71039008|NCT02597049|141585604|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.023|TWO_SIDED|95.0|-2.4|-0.2|||ANCOVA|||Efficacy Estimand||-0.2|-2.4|0.023
71039009|NCT02597049|141585604|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.32|TWO_SIDED|95.0|-1.7|0.6|||ANCOVA|||Efficacy Estimand||0.6|-1.7|0.320
71039010|NCT02463487|141585609|OTHER|||||||0.87|||||||t-test, 1 sided|||||||0.87
71039011|NCT02463487|141585611|OTHER|||||||0.08|||||||t-test, 2 sided|||||||0.08
71039012|NCT01390948|141585643|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.44||||0.1292|TWO_SIDED|95.0|0.9|2.3|||Log Rank|||||2.30|0.90|0.1292
70989984|NCT04525222|141488323|OTHER||Slope|2.92||||0.75|TWO_SIDED|95.0|-15.22|21.07|||Negative Binomial Regression|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||21.07|-15.22|0.75
70989985|NCT04525222|141488324|OTHER||Odds Ratio (OR)|1.33||||0.55|TWO_SIDED|95.0|0.5|3.48|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||3.48|0.5|0.55
70989986|NCT04525222|141488325|OTHER||Odds Ratio (OR)|1.63||||0.17|TWO_SIDED|95.0|0.8|3.32|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking \<20 Cigs/ \>=20 Cigs, Baseline Depression Severity PHQ-8\<5 / PHQ-8\>=5||||3.32|0.80|0.17
70989987|NCT04525222|141488326|OTHER||Odds Ratio (OR)|1.63||||0.25|TWO_SIDED|95.0|0.7|3.81|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||3.81|0.70|0.25
70989988|NCT04525222|141488327|OTHER||Odds Ratio (OR)|1.88||||0.07|TWO_SIDED|95.0|0.94|3.72||Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)|Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||3.72|0.94|0.07
70989989|NCT04525222|141488328|OTHER||Odds Ratio (OR)|2.42||||0.04|TWO_SIDED|95.0|1.0|5.85|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||5.85|1.00|0.04
70989990|NCT04525222|141488329|OTHER||Odds Ratio (OR)|1.47||||0.25|TWO_SIDED|95.0|0.75|2.89|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||2.89|0.75|0.25
70989991|NCT04525222|141488330|OTHER||Odds Ratio (OR)|1.78||||0.17|TWO_SIDED|95.0|0.77|4.12|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||4.12|0.77|0.17
70989992|NCT04525222|141488331|OTHER||Odds Ratio (OR)|1.91||||0.15|TWO_SIDED|95.0|0.77|4.73|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||4.73|0.77|0.15
70989993|NCT04525222|141488332|OTHER||Odds Ratio (OR)|1.25||||0.68|TWO_SIDED|95.0|0.41|3.86|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||3.86|0.41|0.68
70989994|NCT04525222|141488333|OTHER||Odds Ratio (OR)|1.63||||0.21|TWO_SIDED|95.0|0.75|3.46|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||3.46|0.75|0.21
70989995|NCT04525222|141488334|OTHER||Odds Ratio (OR)|1.63||||0.3|TWO_SIDED|95.0|0.63|4.19|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||4.19|0.63|0.30
70989996|NCT04525222|141488335|OTHER||Slope|-1.68||||0.0072|TWO_SIDED|95.0|-2.9|-0.46|||Regression, Linear|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||-0.46|-2.90|.0072
70989997|NCT04525222|141488336|OTHER||Odds Ratio (OR)|1.829||||0.177|TWO_SIDED|95.0|0.77|4.344|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||4.344|0.770|0.1770
70989998|NCT04525222|141488337|OTHER||Slope|3.62||||0.0025|TWO_SIDED|95.0|1.28|5.95|||Regression, Linear|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression, Baseline Activation Score||||5.95|1.28|0.0025
70989999|NCT02026271|141488350|OTHER||||||||||||||||||"MTD was not determined in this study. Dose escalation decision rules were based on a standard 3+3 design modified to independently evaluate the two stratified subject groups that may exhibit different safety and tolerability profiles.~The study was planned to explore 4 veledimex (V) dose cohorts of 20, 40, 80 and 120 mg once daily, and two doses of Ad-RTS-hIL-12 (2x10\^11vp and 1x10\^12vp). Dose cohorts were treated at 10, 20, 30 and 40 mg of V. Only one dose of Ad-RTS-hIL-12 was explored (2x10\^11vp).~If ≥ 33% of subjects in the expansion cohort experience DLTs, additional subjects may be enrolled at the next lower dose, or at an intermediate dose, as recommended by the SRC.~Grp 1: After 20mg cohort, SRC approved 40mg, which was deemed the MAD due to DLTs. SRC approved 30mg cohort to determine MTD, but due to poor compliance, SRC opened a 20mg exp cohort and then an intermediate 10mg cohort. Based on V compliance and efficacy, 20mg was determined to be the optimal dose."|||
70990000|NCT00320385|141488358|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.008|TWO_SIDED|95.0|0.57|0.93|||Log Rank||The Pike estimator of the treatment hazard ratio based on the log-rank test was provided, together with a 95% confidence interval.|||0.93|0.57|0.008
70990001|NCT00320385|141488359|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.106|TWO_SIDED|95.0|0.53|1.07|||Log Rank||The Pike estimator of the treatment hazard ratio based on the log-rank test was provided, together with a 95% confidence interval.|||1.07|0.53|0.106
70990002|NCT00320385|141488360|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.46|TWO_SIDED|95.0|0.6|3.9|||Fisher Exact||Responses were compared between treatment arms using stratified Fisher's exact tests.|||3.9|0.6|0.460
70990003|NCT00320385|141488361|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.01|TWO_SIDED|95.0|1.2|4.5|||Fisher Exact||Clinical Benefit was compared between treatment arms using stratified Fisher's exact tests.|||4.5|1.2|0.010
71039013|NCT05740098|141585660|SUPERIORITY||Odds Ratio (OR)|5.378|||<|0.001|TWO_SIDED|95.0|2.278|12.689|||Mixed Models Analysis|||Analysis tested for significant main effects of treatment condition on 7-day point prevalence abstinence at 12- and 24-week assessments||12.689|2.278|<0.001
71039014|NCT05740098|141585660|SUPERIORITY||Odds Ratio (OR)|3.668||||0.003|TWO_SIDED|95.0|1.538|8.747|||Mixed Models Analysis|||Analysis tested for significant main effects of treatment condition on 7-day point prevalence abstinence at 12- and 24-week assessments||8.747|1.538|0.003
71039015|NCT05740098|141585660|SUPERIORITY||Odds Ratio (OR)|0.682||||0.256|TWO_SIDED|95.0|0.352|1.321|||Mixed Models Analysis|||Analysis tested for significant main effects of treatment condition on 7-day point prevalence abstinence at 12- and 24-week assessments||1.321|0.352|0.256
70990004|NCT04743635|141488366|OTHER|"Performance goal.~Hypothesis:~Ho: D \< 1 Ha: D ≥ 1, where D = reduction in the CSS score from baseline to 3 months, and 1 is the performance goal. If the lower bound of the two-sided 95% confidence interval is greater than or equal to 1 then we will reject the null hypothesis and conclude the device performs effectively."|Mean Difference (Final Values)|1.5|STANDARD_DEVIATION|0.9||0.0001|TWO_SIDED|95.0|1.28|1.71|||t-test, 2 sided|The 2-sided 95% confidence interval for the mean reduction in CSS was calculated along with the corresponding p-value (Student's t-test).||The endpoint tested the mean of the changes for each treated participant, not a 1-point change between mean score of the group at baseline versus 3 months. Success is achieved when the mean change across all treated participants is at least one point.||1.71|1.28|.0001
70990005|NCT04743635|141488367|OTHER|Performance goal. The hierarchal endpoint is met if the lower bound of the 2-sided 95% confidence interval is greater than or equal to 0.6.|Percentage improved|95.6||||0.0001|TWO_SIDED|95.0|87.6|99.1|||t-test, 2 sided|||"The GAIS scale counted if at least two of the three evaluators selected it, otherwise the median between the three was counted (e.g., if improved, worse and much worse, worse was counted). A participant is considered improved if the GAIS assessment is improved (1), much improved (2) or very much improved (3)."||99.1|87.6|.0001
70990006|NCT04743635|141488370|OTHER|Performance goal. In order to meet the endpoint, the lower bound of the 2-sided 95% confidence interval had to be greater than or equal to 0.6.|Percentage improved|72.1||||0.0264|TWO_SIDED|95.0|59.9|82.3|||t-test, 2 sided|||||82.3|59.9|.0264
71039016|NCT05740098|141585660|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Analysis tested for significant main effect of time on 7-day point prevalence abstinence at 12- and 24-week assessments||||<0.001
71039017|NCT05740098|141585661|SUPERIORITY||Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.365||0.287|TWO_SIDED||||||Mixed Models Analysis|||Analysis tested for significant main effect of treatment condition on Child Urine Cotinine||||0.287
71039018|NCT05740098|141585661|SUPERIORITY||Mean Difference (Final Values)|-0.597|STANDARD_ERROR_OF_MEAN|0.369||0.108|TWO_SIDED||||||Mixed Models Analysis|||Analysis tested for significant main effect of treatment condition on Child Urine Cotinine||||0.108
71039019|NCT05740098|141585661|SUPERIORITY||Mean Difference (Final Values)|-0.987|STANDARD_ERROR_OF_MEAN|0.361||0.007|TWO_SIDED||||||Mixed Models Analysis|||Analysis tested for significant main effect of treatment condition on Child Urine Cotinine||||0.007
70990007|NCT03382899|141488379|SUPERIORITY||Odds Ratio (OR)|1.1||||0.7626|TWO_SIDED|95.0|0.5|2.5|||Cochran-Mantel-Haenszel||Odds Ratio stratified by histology type, squamous versus non-squamous based on interactive web response system (IWRS). 95% Confidence intervals (CIs) were estimated using the Clopper-Pearson method.|||2.5|0.5|0.7626
70922825|NCT03833167|141336694|SUPERIORITY||Mean Difference (Final Values)|-3.41||||0.2227|TWO_SIDED|95.0|-8.91|2.09||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Extracapsular extension, Cortical bone invasion, and Prior systemic therapy.|Log Rank||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Extracapsular extension, Cortical bone invasion, and Prior systemic therapy.|||2.09|-8.91|0.2227
71039020|NCT05740098|141585661|SUPERIORITY|||||||0.878|||||||Mixed Models Analysis|||Analysis tested for significant main effect of time on Child Urine Cotinine||||0.878
71039021|NCT05740098|141585662|SUPERIORITY||Chi-Square Test Statistic|6.909||||0.009|TWO_SIDED||||||Chi-squared|Degrees of freedom = 1||Analysis tested for significant main effect of treatment condition on continuous abstinence at 24 weeks following quit date||||0.009
71039022|NCT05740098|141585662|SUPERIORITY||Chi-Square Test Statistic|4.287||||0.038|TWO_SIDED||||||Chi-squared|Degrees of freedom = 1||Analysis tested for significant main effect of treatment condition on continuous abstinence at 24 weeks following quit date||||0.038
71039023|NCT05740098|141585662|SUPERIORITY||Chi-Square Test Statistic|0.392||||0.531|TWO_SIDED||||||Chi-squared|Degrees of freedom = 1||Analysis tested for significant main effect of treatment condition on continuous abstinence at 24 weeks following quit date||||0.531
71039024|NCT05740098|141585663|SUPERIORITY||Chi-Square Test Statistic|3.859||||0.145|TWO_SIDED||||||Chi-squared|Degrees of freedom = 2||Analysis tested for significant main effect of treatment condition on 7-day point prevalence abstinence at 48-week follow-up||||0.145
71039025|NCT05740098|141585664|SUPERIORITY||Wald Chi-Square Test Statistic|1.454||||0.228|TWO_SIDED||||||Regression, Logistic|||Analysis tested for significant main effect of baseline temporal discounting on point-prevalence abstinence at 6-weeks following quit date adjusting for treatment condition.||||0.228
71039026|NCT05740098|141585664|SUPERIORITY||Wald Chi-Square Test Statistic|2.7||||0.1|TWO_SIDED||||||Regression, Logistic|||Analysis tested for significant main effect of baseline temporal discounting on point-prevalence abstinence at 12-weeks following quit date adjusting for treatment condition.||||0.10
71039027|NCT05740098|141585664|SUPERIORITY||Wald Chi-Square Test Statistic|3.202||||0.074|TWO_SIDED||||||Regression, Logistic|||Analysis tested for significant main effect of baseline temporal discounting on point-prevalence abstinence at 24-weeks following quit date adjusting for treatment condition.||||0.074
71039028|NCT05740098|141585664|SUPERIORITY||Wald Chi-Square Test Statistic|0.491||||0.484|TWO_SIDED||||||Regression, Logistic|||Analysis tested for significant main effect of baseline temporal discounting on point-prevalence abstinence at 48-weeks following quit date adjusting for treatment condition.||||0.484
71039029|NCT05740098|141585665|SUPERIORITY||Wald Chi-Square Test Statistic|1.063||||0.302|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Amplitude) and abstinence at 6-weeks following quit date||||0.302
71039030|NCT05740098|141585665|SUPERIORITY||Wald Chi-Square Test Statistic|0.788||||0.375|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Amplitude) and abstinence at 12-weeks following quit date||||0.375
70990008|NCT03382899|141488380|SUPERIORITY||Hazard Ratio (HR)|1.53||||0.263|TWO_SIDED|95.0|0.722|3.243|||Log Rank||Hazard Ratio stratified by histology type, squamous versus non-squamous based on IWRS. 95% CIs were estimated using the methods of Brookmeyer and Crowley, and Greenwood, respectively.|||3.243|0.722|0.263
70990009|NCT03382899|141488381|SUPERIORITY||Hazard Ratio (HR)|0.975||||0.2|TWO_SIDED|95.0|0.571|1.663|||Log Rank||Hazard Ratio stratified by histology type, squamous versus non-squamous based on IWRS. 95% CIs were estimated using the Kaplan-Meier method.|||1.663|0.571|0.20
70990010|NCT03382899|141488382|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9418|TWO_SIDED|95.0|0.5|2.3|||Cochran-Mantel-Haenszel||Odds Ratio stratified by histology type, squamous versus non-squamous based on IWRS. 95% CIs were estimated using the Clopper-Pearson method.|||2.3|0.5|0.9418
70990011|NCT03382899|141488383|SUPERIORITY||Hazard Ratio (HR)|1.124||||0.8312|TWO_SIDED|95.0|0.384|3.289|||Log Rank||Hazard Ratio stratified by histology type, squamous versus non-squamous based on IWRS. 95% CIs were estimated using the methods of Brookmeyer and Crowley, and Greenwood, respectively.|||3.289|0.384|0.8312
70990012|NCT01355068|141488384|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Means|101.33|||||TWO_SIDED|90.0|97.85|104.94||||||Natural log transformed AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||104.94|97.85|
70990013|NCT01355068|141488385|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Means|102.2|||||TWO_SIDED|90.0|97.18|107.47||||||Natural log transformed Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||107.47|97.18|
70990014|NCT01355068|141488386|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Means|101.43|||||TWO_SIDED|90.0|97.56|105.47||||||Natural log transformed AUC (0-∞) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||105.47|97.56|
70990015|NCT00872170|141488394|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||This study had 80% power at level alpha=0.05 to detect a 60 m change in 6MWT among N=10 participants, assuming a 60 m standard deviation for 12-week change.||||0.97
70990016|NCT00872170|141488395|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.04
70990017|NCT00872170|141488396|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.005
70990018|NCT00872170|141488397|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.02
70990019|NCT00872170|141488398|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.05
70990020|NCT00872170|141488399|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.02
71039031|NCT05740098|141585665|SUPERIORITY||Wald Chi-Square Test Statistic|0.08||||0.777|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Amplitude) and abstinence at 24-weeks following quit date||||0.777
71039032|NCT05740098|141585665|SUPERIORITY||Wald Chi-Square Test Statistic|0.006||||0.937|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Amplitude) and abstinence at 48-weeks following quit date||||0.937
71039033|NCT05740098|141585665|SUPERIORITY||Wald Chi-Square Test Statistic|0.172||||0.678|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Persistence) and abstinence at 6-weeks following quit date||||0.678
71039034|NCT05740098|141585665|SUPERIORITY||Wald Chi-Square Test Statistic|7.99||||0.018|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant interaction between baseline price sensitivity (latent factor Persistence) and treatment condition for 6-week abstinence outcome||||0.018
70990021|NCT00872170|141488400|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.04
70990022|NCT00872170|141488401|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.33
70990023|NCT00872170|141488402|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.18
70990024|NCT00872170|141488403|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.97
71039035|NCT05740098|141585665|SUPERIORITY||Wald Chi-Square Test Statistic|0.177||||0.674|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Persistence) and abstinence at 12-weeks following quit date||||0.674
71039036|NCT05740098|141585665|SUPERIORITY||Wald Chi-Square Test Statistic|0.646||||0.422|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Persistence) and abstinence at 24-weeks following quit date||||0.422
71039037|NCT05740098|141585665|SUPERIORITY||Wald Chi-Square Test Statistic|0.038||||0.846|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Persistence) and abstinence at 48-weeks following quit date||||0.846
71039038|NCT02452463|141585670|SUPERIORITY|||||||0.107|||||||Cochran-Mantel-Haenszel|||||||0.107
71039039|NCT02452463|141585672|SUPERIORITY|||||||0.75|||||||Log Rank|||Null Hypotheses: OS distributions are equal||||0.75
70990025|NCT00872170|141488404|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.96
70990026|NCT00540449|141488405|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|-0.4|||<|0.0001||95.0|-5.9|5.2||Significance level was set at 2.5% (one-sided). No adjustment of p-value for multiple comparisons, since there was only single comparison for the primary endpoint.|Regression, Logistic|Logistic regression model included treatment arm as factor and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|Assuming a response rate of 75% at 48 weeks for both treatment groups, 340 subjects were needed per treatment (TMC278 or EFV) to establish non-inferiority of TMC278 versus EFV with a maximum allowable difference of 12% and a 1-sided significance level of 2.5%, to yield 95% power.||5.2|-5.9|<0.0001
71039040|NCT02452463|141585673|SUPERIORITY|||||||0.25|||||||Log Rank|||Null Hypotheses: PFS distributions are equal||||0.25
71039041|NCT02452463|141585674|SUPERIORITY|||||||0.131|||||||t-test, 2 sided|||||||0.131
71039042|NCT02452463|141585675|SUPERIORITY|||||||0.073|||||||t-test, 2 sided|||||||0.073
71039043|NCT02452463|141585676|SUPERIORITY|||||||0.616|||||||t-test, 2 sided|||||||0.616
71039044|NCT02452463|141585676|SUPERIORITY|||||||0.183|||||||Paired T-test|||Comparing change relative to baseline.||||0.183
71039045|NCT02452463|141585676|SUPERIORITY|||||||0.203|||||||paired T-test|||Evaluating change relative to baseline.||||0.203
71039046|NCT02452463|141585677|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||||||1.00
71039047|NCT03555695|141585734|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.12|TWO_SIDED||||||t-test, 2 sided|||||||0.12
71039048|NCT01894230|141585775|EQUIVALENCE|Month 3|Slope|-0.0189|STANDARD_ERROR_OF_MEAN|0.3986||0.96|TWO_SIDED||||||Regression, Linear|||||||0.96
71039049|NCT01894230|141585775|EQUIVALENCE|Month 8|Slope|-0.2468|STANDARD_ERROR_OF_MEAN|0.4315||0.57|TWO_SIDED||||||Regression, Linear|||||||0.57
71039050|NCT01894230|141585776|EQUIVALENCE|Month 3|Slope|-11.32|STANDARD_ERROR_OF_MEAN|5.68||0.0482|TWO_SIDED||||||Regression, Linear|||||||0.0482
71039051|NCT01894230|141585776|EQUIVALENCE|Month 8|Slope|-9.9|STANDARD_ERROR_OF_MEAN|6.333||0.12|TWO_SIDED||||||Regression, Linear|||||||0.12
71039052|NCT01894230|141585777|EQUIVALENCE|MPR calculated from baseline to last patient follow-up (3 months or 8 months)|Slope|-0.053|STANDARD_ERROR_OF_MEAN|0.091||0.6692|TWO_SIDED||||||Regression, Linear|||||||0.6692
71039053|NCT01894230|141585778|EQUIVALENCE|Baseline to Month 3|Odds Ratio (OR)|2.025||||0.0371|TWO_SIDED|95.0|1.043|3.929|||Regression, Logistic|||||3.929|1.043|0.0371
71039054|NCT01894230|141585778|EQUIVALENCE|Month 3 to Month 8|Odds Ratio (OR)|1.115||||0.8815|TWO_SIDED|95.0|0.265|4.687|||Regression, Logistic|||||4.687|0.265|0.8815
71039055|NCT01894230|141585779|EQUIVALENCE|Month 3|Slope|0.143|STANDARD_ERROR_OF_MEAN|0.27||0.5965|TWO_SIDED||||||Regression, Linear|||||||0.5965
70990027|NCT00540449|141488406|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|0.3|||<|0.0001||95.0|-5.4|5.9|||Regression, Logistic|Logistic regression model included treatment arm as factor and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|||5.9|-5.4|<0.0001
70990028|NCT00540449|141488407|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|-3.2||||0.0055||95.0|-9.4|3.1|||Regression, Logistic|Logistic regression model included treatment arm as factor and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|||3.1|-9.4|0.0055
70990029|NCT00540449|141488408|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|-1.7||||0.0013||95.0|-8.0|4.5|||Regression, Logistic|Logistic regression model included treatment arm as factor and baseline (log10) viral load as covariate.||||4.5|-8.0|0.0013
70990030|NCT01721408|141488414|NON_INFERIORITY_OR_EQUIVALENCE|Assuming that the 2 treatments were equally effective, with cure rates of 75 % at the TOC assessment, the study was powered to ensure with 90% probability that the lower limit of a 2-sided 95% confidence interval (CI) for the true difference (tigecycline minus imipenem/cilastatin) in cure rates was greater than -15%.|Difference in percentage|-6.7||||0.0008|TWO_SIDED|95.0|-12.0|-1.4|||See method of CI||Used the asymptotic method corrected for continuity with normal distribution approximation. Non-inferiority test was conducted on the CE population. If non-inferiority was concluded, superiority test was conducted on both the CE and mITT populations.|||-1.4|-12.0|0.0008
70990031|NCT01721408|141488415|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower limit of the 2-sided CI for the difference in cure rates between treatment groups (tigecycline minus imipenem/cilastatin) was greater than -15%.|Difference in percentage|-7.3||||0.0277|TWO_SIDED|95.0|-15.2|0.5|||See method of CI||CIs and p-values for between-group treatment difference in cure rate were calculated by the asymptotic method corrected for continuity with normal distribution approximation.|||0.5|-15.2|0.0277
70990032|NCT01721408|141488416|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower limit of the 2-sided CI for the difference in eradication rates between treatment groups (tigecycline minus imipenem/cilastatin) was greater than -15%.|Difference in percentage|-7.3||||0.0277|TWO_SIDED|95.0|-15.2|0.5|||See method of CI||CIs and p-values for between-group treatment difference in eradication rates were calculated by the asymptotic method corrected for continuity with normal distribution approximation.|||0.5|-15.2|0.0277
70990033|NCT01721408|141488418|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower limit of the 2-sided CI for the difference in cure rates between treatment groups (tigecycline minus imipenem/cilastatin) was greater than -15%.|Difference in percentage|-6.0||||0.004|TWO_SIDED|95.0|-12.8|0.8|||See method of CI||Used the asymptotic method corrected for continuity with normal distribution approximation. Non-inferiority test was conducted on the CE population. If non-inferiority was concluded, superiority test was conducted on both the CE and mITT populations.|||0.8|-12.8|0.0040
70990034|NCT02426658|141488419|SUPERIORITY|||||||0.7044|||||||Mixed Models Analysis|||||||0.7044
70990035|NCT04937816|141488443|OTHER||Hazard Ratio (HR)|1.0||||0.9946|TWO_SIDED|95.0|0.83|1.2|||Regression, Cox|Cox regression of time to first vascular AE. Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/ Placebo\].|Time to first vascular AE (SAF-M1)||1.20|0.83|0.9946
70990036|NCT04937816|141488443|OTHER||Hazard Ratio (HR)|0.95||||0.7474|TWO_SIDED|95.0|0.72|1.27|||Regression, Cox|Cox regression of time to first vascular AE. Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus placebo. \[Treatment/Placebo\].|Time to first vascular AE (SAF-M2)||1.27|0.72|0.7474
70990037|NCT04937816|141488443|OTHER||Hazard Ratio (HR)|1.03||||0.7943|TWO_SIDED|95.0|0.81|1.31|||Regression, Cox|Cox regression for time to first vascular AE on-treatment. Cox regression model with a term for treatment.|Comparison vs. Placebo \[Treatment / Placebo\]|Time to first vascular AE (Trial NCT01131676, all empagliflozin (10 and 25 mg vs. Placebo))||1.31|0.81|0.7943
70990038|NCT04937816|141488443|OTHER||Hazard Ratio (HR)|0.97||||0.8518|TWO_SIDED|95.0|0.69|1.36|||Regression, Cox|Cox regression for time to first vascular AE on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs. Placebo \[Treatment / Placebo\].|Time to first vascular AE (Trial NCT03057951)||1.36|0.69|0.8518
70990039|NCT04937816|141488443|OTHER||Hazard Ratio (HR)|0.93||||0.766|TWO_SIDED|95.0|0.56|1.53|||Regression, Cox|Cox regression for time to first vascular AE on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first vascular AE (Trial NCT03057977)||1.53|0.56|0.7660
70990040|NCT04937816|141488443|OTHER||Hazard Ratio (HR)|1.15||||0.3612|TWO_SIDED|95.0|0.85|1.55|||Regression, Cox|Cox regression of time to first diabetic foot related AE. Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus placebo \[Treatment/Placebo\].|Time to first diabetic foot related AE (SAF-M1)||1.55|0.85|0.3612
70990041|NCT04937816|141488443|OTHER||Hazard Ratio (HR)|1.44||||0.161|TWO_SIDED|95.0|0.86|2.4|||Regression, Cox|Cox regression of time to first diabetic foot related AE. Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first diabetic foot related AE (SAF-M2)||2.40|0.86|0.1610
70990042|NCT04937816|141488443|OTHER||Hazard Ratio (HR)|1.02||||0.9128|TWO_SIDED|95.0|0.71|1.47|||Regression, Cox|Cox regression for time to first diabetic foot related AE on treatment. Cox regression model with a term for treatment.|Comparison vs. Placebo \[Treatment/Placebo\]|Time to first diabetic foot related AE (Trial NCT01131676, all empagliflozin (10 and 25 mg) vs. Placebo)||1.47|0.71|0.9128
71039056|NCT01894230|141585779|EQUIVALENCE|Month 8|Slope|0.258|STANDARD_ERROR_OF_MEAN|0.346||0.4579|TWO_SIDED||||||Regression, Linear|||||||0.4579
71039057|NCT01894230|141585780|EQUIVALENCE|Month 3|Slope|0.098|STANDARD_ERROR_OF_MEAN|0.163||0.5477|TWO_SIDED||||||Regression, Linear|||||||0.5477
70990043|NCT04937816|141488443|OTHER||Hazard Ratio (HR)|0.81||||0.5276|TWO_SIDED|95.0|0.43|1.54|||Regression, Cox|Cox regression for time to first diabetic foot related AE. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs. Placebo \[Treatment/Placebo\]|Time to first diabetic foot related AE (Trial NCT03057951)||1.54|0.43|0.5276
70990044|NCT04937816|141488443|OTHER||Hazard Ratio (HR)|4.72||||0.0048|TWO_SIDED|95.0|1.6|13.87|||Regression, Cox|Cox regression for time to first diabetic foot related AE. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment / Placebo\]|Time to first diabetic foot related AE (Trial NCT03057977)||13.87|1.60|0.0048
70990045|NCT04937816|141488443|OTHER||Hazard Ratio (HR)|0.89||||0.1526|TWO_SIDED|95.0|0.77|1.04|||Regression, Cox|Cox regression of time to first infections potentially related to LLA's. Cox regression with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first infections potentially related to LLA's (SAF-M1)||1.04|0.77|0.1526
70990046|NCT04937816|141488443|OTHER||Hazard Ratio (HR)|0.96||||0.743|TWO_SIDED|95.0|0.76|1.21|||Regression, Cox|Cox regression of time to first infection potentially related to LLA's. Cox regression with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first infection potentially related to LLA's (SAF-M2)||1.21|0.76|0.7430
70990047|NCT04937816|141488443|OTHER||Hazard Ratio (HR)|0.85||||0.1049|TWO_SIDED|95.0|0.69|1.04|||Regression, Cox|Cox regression for infections potentially related to LLA-on treatment. Cox regression model with a term for treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first infections potentially related to LLA (Trial NCT01131676, all Empagliflozin (10 mg and 25 mg) vs. Placebo)||1.04|0.69|0.1049
70990048|NCT04937816|141488443|OTHER||Hazard Ratio (HR)|0.89||||0.395|TWO_SIDED|95.0|0.67|1.17|||Regression, Cox|Cox regression for infections potentially related to LLA on treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first infections potentially related to LLA (Trial NCT03057951)||1.17|0.67|0.3950
70990049|NCT04937816|141488443|OTHER||Hazard Ratio (HR)|1.19||||0.4429|TWO_SIDED|95.0|0.76|1.87|||Regression, Cox|Cox regression for infections potentially related to LLA on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first infections potentially related to LLA (Trial NCT03057977)||1.87|0.76|0.4429
70990050|NCT04937816|141488443|OTHER||Hazard Ratio (HR)|0.89||||0.3396|TWO_SIDED|95.0|0.7|1.13|||Regression, Cox|Cox regression of time to first wound infections. Cox regression with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first wound/infection (SAF-M1)||1.13|0.70|0.3396
70990051|NCT04937816|141488443|OTHER||Hazard Ratio (HR)|0.7||||0.105|TWO_SIDED|95.0|0.46|1.08|||Regression, Cox|Cox regression of time to first wound infections. Cox regression with terms for study, baseline diabetes status and treatment|Comparison versus Placebo \[Treatment/Placebo\].|Time to first wound/infection (SAF-M2)||1.08|0.46|0.1050
70990052|NCT04937816|141488443|OTHER||Hazard Ratio (HR)|1.0||||0.9919|TWO_SIDED|95.0|0.74|1.35|||Regression, Cox|Cox regression for time to first wound/infection on-treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first wound/infection (Trial NCT01131676, all Empagliflozin (10 mg and 25 mg) vs Placebo)||1.35|0.74|0.9919
70990053|NCT04937816|141488443|OTHER||Hazard Ratio (HR)|0.79||||0.3634|TWO_SIDED|95.0|0.48|1.31|||Regression, Cox|Cox regression for time to first wound/infection on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first wound/infection (Trial NCT03057951)||1.31|0.48|0.3634
70990054|NCT04937816|141488443|OTHER||Hazard Ratio (HR)|0.52||||0.1177|TWO_SIDED|95.0|0.23|1.18|||Regression, Cox|Cox regression for time to first wound/infection on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first wound/infection (Trial NCT03057977)||1.18|0.23|0.1177
70990055|NCT04937816|141488443|OTHER||Hazard Ratio (HR)|1.0||||0.9992|TWO_SIDED|95.0|0.84|1.19|||Regression, Cox|Cox regression of time to first nervous system disorder. Cox regression with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first nervous system disorder (SAF-M1)||1.19|0.84|0.9992
70990056|NCT04937816|141488443|OTHER||Hazard Ratio (HR)|1.09||||0.6274|TWO_SIDED|95.0|0.78|1.52|||Regression, Cox|Cox regression of time to first nervous system disorder. Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first nervous system disorder (SAF-M2)||1.52|0.78|0.6274
71039058|NCT01894230|141585780|EQUIVALENCE|Month 8|Slope|0.298|STANDARD_ERROR_OF_MEAN|0.145||0.0429|TWO_SIDED||||||Regression, Linear|||||||0.0429
70990057|NCT04937816|141488443|OTHER||Hazard Ratio (HR)|0.97||||0.7597|TWO_SIDED|95.0|0.79|1.19|||Regression, Cox|Cox regression for time to first nervous system disorder on-treatment. Cox regression model with a term for treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first nervous system disorder (Trial NCT01131676, all Empagliflozin (10 mg and 25 mg) vs Placebo)||1.19|0.79|0.7597
70990058|NCT04937816|141488443|OTHER||Hazard Ratio (HR)|1.08||||0.7067|TWO_SIDED|95.0|0.74|1.57|||Regression, Cox|Cox regression for time to first nervous system disorder on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first nervous system disorder (Trial NCT03057951)||1.57|0.74|0.7067
70990059|NCT04937816|141488443|OTHER||Hazard Ratio (HR)|1.12||||0.7404|TWO_SIDED|95.0|0.56|2.25|||Regression, Cox|Cox regression for time to first nervous system disorder on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|time to first nervous system disorder (Trial NCT03057977)||2.25|0.56|0.7404
70990060|NCT04937816|141488443|OTHER||Hazard Ratio (HR)|1.21||||0.1765|TWO_SIDED|95.0|0.92|1.58|||Regression, Cox|Cox regression of time to first volume depletion AE. Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first volume depletion AE (SAF-M1)||1.58|0.92|0.1765
71039059|NCT01894230|141585781|EQUIVALENCE|Month 3|Slope|-0.211|STANDARD_ERROR_OF_MEAN|0.881||0.8106|TWO_SIDED||||||Regression, Linear|||||||0.8106
71039060|NCT01894230|141585781|EQUIVALENCE|Month 8|Slope|0.646|STANDARD_ERROR_OF_MEAN|1.009||0.5233|TWO_SIDED||||||Regression, Linear|||||||0.5233
71039061|NCT01894230|141585782|EQUIVALENCE|Month 3|Slope|-0.6001|STANDARD_ERROR_OF_MEAN|1.472||0.6841|TWO_SIDED||||||Regression, Linear|||||||0.6841
70990061|NCT04937816|141488443|OTHER||Hazard Ratio (HR)|1.22||||0.1978|TWO_SIDED|95.0|0.9|1.66|||Regression, Cox|Cox regression of time to first volume depletion AE. Cox regression with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first volume depletion AE (SAF-M2)||1.66|0.90|0.1978
70990062|NCT04937816|141488443|OTHER||Hazard Ratio (HR)|1.14||||0.6561|TWO_SIDED|95.0|0.64|2.05|||Regression, Cox|Cox regression for time to first volume depletion on-treatment. Cox regression model with a term for treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first volume depletion (Trial NCT01131676, all Empagliflozin (10 mg and 25 mg) vs Placebo)||2.05|0.64|0.6561
70990063|NCT04937816|141488443|OTHER||Hazard Ratio (HR)|1.29||||0.1699|TWO_SIDED|95.0|0.9|1.87|||Regression, Cox|Cox regression for time to first volume depletion on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first volume depletion (Trial NCT03057951)||1.87|0.90|0.1699
70990064|NCT04937816|141488443|OTHER||Hazard Ratio (HR)|1.08||||0.7944|TWO_SIDED|95.0|0.62|1.87|||Regression, Cox|Cox regression for time to first volume depletion on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first volume depletion (Trial NCT03057977)||1.87|0.62|0.7944
70990065|NCT04937816|141488444|OTHER||Hazard Ratio (HR)|1.02||||0.9276|TWO_SIDED|95.0|0.73|1.42|||Regression, Cox|Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus placebo \[Treatment/Placebo\].|||1.42|0.73|0.9276
71098658|NCT03537729|141705808|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Ratio of mean proportions of errors|0.65||||0.04|TWO_SIDED|95.0|0.44|0.99||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Generalized mixed model analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Ratio of mean proportion of errors for cues divided by proportion of errors for control. Log of the mean was estimated from generalized linear mixed effects models for each arm. The difference between logs of means for two arms was exponentiated.|The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.||0.99|0.44|0.04
70990066|NCT04937816|141488444|OTHER||Hazard Ratio (HR)|0.85||||0.6205|TWO_SIDED|95.0|0.45|1.6|||Regression, Cox|Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus placebo \[Treatment/Placebo\]|||1.60|0.45|0.6205
70990067|NCT04937816|141488444|OTHER||Hazard Ratio (HR)|1.09||||0.6768|TWO_SIDED|95.0|0.73|1.63|||Regression, Cox|Cox regression model with terms for treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Empagliflozin (10 mg + 25 mg) versus Placebo.||1.63|0.73|0.6768
70990068|NCT04937816|141488444|OTHER||Hazard Ratio (HR)|0.73||||0.4294|TWO_SIDED|95.0|0.34|1.59|||Regression, Cox|Cox regression model with terms for baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment /Placebo\]|||1.59|0.34|0.4294
70990069|NCT04937816|141488444|OTHER||Hazard Ratio (HR)|1.17||||0.7826|TWO_SIDED|95.0|0.39|3.47|||Regression, Cox|Cox regression model with terms for baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment /Placebo\]|||3.47|0.39|0.7826
70990070|NCT01345123|141488469|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0019994|STANDARD_ERROR_OF_MEAN|0.0400918||0.9602|TWO_SIDED|95.0|-0.0765899|0.080588716|||ANCOVA|Covariates: age, gender, Charlson Comorbidity Index, prior year total medical costs pmpm||||.080588716|-.07658990|0.9602
70990071|NCT01345123|141488469|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.013717|STANDARD_ERROR_OF_MEAN|0.04018791||0.7329|TWO_SIDED|95.0|-0.0924947|0.06506063|||ANCOVA|||||0.06506063|-0.0924947|0.7329
70990072|NCT01345123|141488470|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.805||||0.0511||95.0|0.647|1.001|||Regression, Logistic|Covariates: Age, Gender, Charlson Comorbidity index, calculated risk of knee replacement, hip replacement, herniated disc surgery (score 1-99)||||1.001|0.647|0.0511
70990073|NCT01345123|141488473|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.31257||||0.0106|TWO_SIDED|95.0|0.06895|0.55618|||ANOVA|||||0.55618|0.06895|0.0106
70990074|NCT01345123|141488473|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15982||||0.0106|TWO_SIDED|95.0|-0.06477|0.38441|||ANOVA|||||0.38441|-0.06477|0.0106
70990075|NCT01345123|141488476|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.009122|STANDARD_ERROR_OF_MEAN|0.0467091||0.8454|TWO_SIDED|95.0|-0.1008434|0.08259938|||ANCOVA|||||0.08259938|-0.1008434|0.8454
70990076|NCT01345123|141488476|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0183548|STANDARD_ERROR_OF_MEAN|0.04690321||0.6956|TWO_SIDED|95.0|-0.1102961|0.07358642|||ANCOVA|||||0.07358642|-0.1102961|0.6956
70990077|NCT00335504|141488481|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||Adjusting for multiple comparisons yields 84% power to detect a difference of at least 25% in % change of ACF at the 0.016 level of significance and using a two-sample, 2-sided t-test.|Wilcoxon (Mann-Whitney)|||The study was designed to test the hypotheses of observing a 25% difference in % change ACF over baseline, between patients treated with atorvastatin compared to placebo. N=25 subjects per group yielded 93% power to detect this difference using a 2 sided t-test at significance level of 0.05. Non-parametric tests (eg, Wilcoxon Rank Sum) could be used if the statistical assumptions of the t-test were violated.||||0.30
70990078|NCT00335504|141488481|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||Adjusting for multiple comparisons yields 84% power to detect a difference of at least 25% in % change of ACF at the 0.016 level of significance and using a two-sample, 2-sided t-test.|Wilcoxon (Mann-Whitney)|||The study was designed to test the hypotheses of observing a 25% difference in % change ACF over baseline, between patients treated with sulindac compared to placebo. N=25 subjects per group yielded 93% power to detect this difference using a 2 sided t-test at significance level of 0.05. Non-parametric tests (eg, Wilcoxon Rank Sum) could be used if the statistical assumptions of the t-test were violated.||||0.60
70990079|NCT00335504|141488481|SUPERIORITY_OR_OTHER|||||||0.92||95.0||||Adjusting for multiple comparisons yields 84% power to detect a difference of at least 25% in % change of ACF at the 0.016 level of significance and using a two-sample, 2-sided t-test.|Wilcoxon (Mann-Whitney)|||The study was designed to test the hypotheses of observing a 25% difference in % change ACF over baseline, between patients treated with oligofructose-enriched inulin compared to placebo. N=25 subjects per group yielded 93% power to detect this difference using a 2 sided t-test at significance level of 0.05. Non-parametric tests (eg, Wilcoxon Rank Sum) could be used if the statistical assumptions of the t-test were violated.||||0.92
70990080|NCT00335504|141488481|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||Sign test|||Signed Rank p-value for comparison of % change in ACF within each randomization arm.||||0.59
70990081|NCT00335504|141488481|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Sign test|||Signed Rank p-value for comparison of % change in ACF within each randomization arm.||||0.12
70990082|NCT00335504|141488481|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||Sign test|||Signed Rank p-value for comparison of % change in ACF within each randomization arm.||||0.54
70990083|NCT00335504|141488481|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||Sign test|||Signed Rank p-value for comparison of % change in ACF within each randomization arm.||||0.41
70990084|NCT00335504|141488482|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in Ki67 between atorvastatin and placebo.||||0.37
70990085|NCT00335504|141488482|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in Ki67 between sulindac and placebo.||||1.00
70990086|NCT00335504|141488482|SUPERIORITY_OR_OTHER|||||||0.58||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in Ki67 between oligofructose-enriched inulin and placebo.||||0.58
70990087|NCT00335504|141488483|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in apoptosis between atorvastatin calcium and placebo.||||0.26
70990088|NCT00335504|141488483|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in apoptosis between sulindac and placebo.||||0.88
70990089|NCT00335504|141488483|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in apoptosis between oligofructose-enriched inulin and placebo.||||0.38
70990090|NCT03456713|141488529|OTHER||Ratio of geometric least squares mean|1.47|||||TWO_SIDED|90.0|1.12|1.94||||||||1.94|1.12|
70990091|NCT03456713|141488530|OTHER||Ratio of geometric least squares mean|1.44|||||TWO_SIDED|90.0|1.15|1.81||||||||1.81|1.15|
70990092|NCT03456713|141488531|OTHER||Ratio of geometric least squares mean|1.66|||||TWO_SIDED|90.0|1.31|2.11||||||||2.11|1.31|
70990093|NCT03456713|141488532|SUPERIORITY||Ratio of Geometric Least Squares Means|0.73|||||TWO_SIDED|90.0|0.43|1.23||||||||1.23|0.43|
70990094|NCT03456713|141488533|OTHER||Ratio of geometric least squares mean|0.98|||||TWO_SIDED|90.0|0.58|1.67||||||||1.67|0.58|
70990095|NCT03456713|141488534|OTHER||Ratio of geometric least squares mean|0.7|||||TWO_SIDED|90.0|0.41|1.2||||||||1.20|0.41|
70990096|NCT01405313|141488535|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Mean Difference (Final Values)|2.5||||0.022|TWO_SIDED|80.0|||||t-test, 1 sided|||||||0.022
71039062|NCT01894230|141585782|EQUIVALENCE|Month 8|Slope|-0.771|STANDARD_ERROR_OF_MEAN|1.781||0.6658|TWO_SIDED||||||Regression, Linear|||||||0.6658
71039063|NCT01894230|141585783|EQUIVALENCE|Month 8|Odds Ratio (OR)|1.085||||0.8384|TWO_SIDED|95.0|0.495|2.38|||Regression, Logistic|Ordinal Logistic||||2.380|0.495|0.8384
70990097|NCT01405313|141488536|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Mean Difference (Final Values)|3.0||||0.016|TWO_SIDED|80.0|||||t-test, 1 sided|||||||0.016
70990098|NCT01533935|141488578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.215|0.315|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Placebo QD|||0.315|0.215|<0.0001
70990099|NCT01533935|141488578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.025||0.0015|TWO_SIDED|95.0|0.031|0.129|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg QD|||0.129|0.031|0.0015
70990100|NCT01533935|141488578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.025||0.0005|TWO_SIDED|95.0|0.039|0.137|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD|||0.137|0.039|0.0005
70990101|NCT01533935|141488578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.274|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.224|0.324|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD|||0.324|0.224|<0.0001
70990102|NCT01533935|141488578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.025||0.0004|TWO_SIDED|95.0|0.039|0.138|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD|||0.138|0.039|0.0004
70990103|NCT01533935|141488578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.025||0.0001|TWO_SIDED|95.0|0.047|0.147|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD|||0.147|0.047|0.0001
70990104|NCT01533935|141488579|SUPERIORITY_OR_OTHER||Ratio|1.134|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001|TWO_SIDED|95.0|1.065|1.206|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 5/5 QD divided by Placebo QD|||1.206|1.065|<0.0001
70990105|NCT01533935|141488579|SUPERIORITY_OR_OTHER||Ratio|1.111|STANDARD_ERROR_OF_MEAN|0.035||0.0009|TWO_SIDED|95.0|1.045|1.182|||Mixed Models Analysis||Ratio calculated Tiotropium + olodaterol 5/5 QD as divided by Olodaterol 5 mcg QD|||1.182|1.045|0.0009
70990106|NCT01533935|141488579|SUPERIORITY_OR_OTHER||Ratio|1.043|STANDARD_ERROR_OF_MEAN|0.033||0.1807|TWO_SIDED|95.0|0.981|1.109|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 5/5 QD divided by Tiotropium 5 mcg QD|||1.109|0.981|0.1807
70990107|NCT01533935|141488579|SUPERIORITY_OR_OTHER||Ratio|1.121|STANDARD_ERROR_OF_MEAN|0.036||0.0003|TWO_SIDED|95.0|1.054|1.193|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 2.5/5 QD divided by Placebo QD|||1.193|1.054|0.0003
70990108|NCT01533935|141488579|SUPERIORITY_OR_OTHER||Ratio|1.099|STANDARD_ERROR_OF_MEAN|0.035||0.0029|TWO_SIDED|95.0|1.033|1.17|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 2.5/5 QD divided by Olodaterol 5 mcg QD|||1.170|1.033|0.0029
70990109|NCT01533935|141488579|SUPERIORITY_OR_OTHER||Ratio|1.032|STANDARD_ERROR_OF_MEAN|0.033||0.324|TWO_SIDED|95.0|0.97|1.098|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 2.5/5 QD divided by Tiotropium 5 mcg QD|||1.098|0.970|0.3240
70990110|NCT01533935|141488580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.001|<|0.0001|TWO_SIDED|95.0|-0.004|-0.002|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Placebo QD|||-0.002|-0.004|<0.0001
70990111|NCT01533935|141488580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.001||0.0033|TWO_SIDED|95.0|-0.003|-0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg QD|||-0.001|-0.003|0.0033
70990112|NCT01533935|141488580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.001||0.2306|TWO_SIDED|95.0|-0.002|0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD|||0.001|-0.002|0.2306
70990113|NCT01533935|141488580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.001|<|0.0001|TWO_SIDED|95.0|-0.005|-0.002|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD|||-0.002|-0.005|<0.0001
70990114|NCT01533935|141488580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.001||0.001|TWO_SIDED|95.0|-0.004|-0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD|||-0.001|-0.004|0.0010
70990115|NCT01533935|141488580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.001||0.1206|TWO_SIDED|95.0|-0.002|0.0|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD|||0.000|-0.002|0.1206
70990116|NCT01533935|141488581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.329|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.294|0.364|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Placebo QD|||0.364|0.294|<0.0001
70990117|NCT01533935|141488581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.099|0.169|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg QD|||0.169|0.099|<0.0001
70990118|NCT01533935|141488581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.1|0.17|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD|||0.170|0.100|<0.0001
70990119|NCT01533935|141488581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.305|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.269|0.34|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD|||0.340|0.269|<0.0001
71039064|NCT01894230|141585784|EQUIVALENCE|Month 3 BMQ Necessity|Slope|1.163|STANDARD_ERROR_OF_MEAN|0.584||0.0486|TWO_SIDED||||||Regression, Linear|||||||0.0486
70990120|NCT01533935|141488581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.075|0.145|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD|||0.145|0.075|<0.0001
70990121|NCT01533935|141488581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.076|0.146|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD|||0.146|0.076|<0.0001
70990122|NCT00316303|141488586|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wald Chi-squared|||||||<0.001
70990123|NCT00316303|141488587|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wald Chi-squared|||||||<0.001
70990124|NCT00316303|141488588|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wald Chi-squared|||||||<0.001
70990125|NCT00316303|141488589|SUPERIORITY_OR_OTHER|||||||0.011|||||||Wald Chi-squared|||||||0.011
70990126|NCT00316303|141488590|SUPERIORITY_OR_OTHER|||||||0.6|||||||Chi-squared|||||||0.6
70990127|NCT00850759|141488591|SUPERIORITY_OR_OTHER||Slope|0.04|||<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
70990128|NCT01753076|141488601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.0||||0.12|TWO_SIDED|95.0|-67.9|7.9|||ANCOVA||A negative mean difference means that the direction of effect is in favor of placebo.|||7.9|-67.9|0.120
70990129|NCT01753076|141488602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.139|TWO_SIDED|95.0|-3.1|0.4|||Mixed Models Analysis|||||0.4|-3.1|0.139
70990130|NCT01753076|141488603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.173|TWO_SIDED|95.0|-0.3|0.05|||Random coefficients analysis|||||0.05|-0.30|0.173
70990131|NCT01753076|141488604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.127||||0.265|TWO_SIDED|95.0|-0.351|0.097|||Mixed Models Analysis|||||0.097|-0.351|0.265
70990132|NCT01753076|141488605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2||||0.125|TWO_SIDED|95.0|-18.7|2.3|||Mixed Models Analysis|||||2.3|-18.7|0.125
70990133|NCT01753076|141488606|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.393|TWO_SIDED|95.0|0.36|1.49|||Regression, Logistic|||||1.49|0.36|0.393
70990134|NCT01753076|141488607|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.986|TWO_SIDED|95.0|0.34|2.89|||Regression, Cox||Week 48|||2.89|0.34|0.986
70990135|NCT01753076|141488607|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.923|TWO_SIDED|95.0|0.53|2.01|||Chi-squared||Week 60|||2.01|0.53|0.923
70990136|NCT01753076|141488608|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.642|TWO_SIDED|95.0|0.81|1.42|||Regression, Cox|||||1.42|0.81|0.642
70990137|NCT01753076|141488609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|||||TWO_SIDED|95.0|-0.062|0.053||||||||0.053|-0.062|
70990138|NCT01753076|141488610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-2.8|5.5||||||||5.5|-2.8|
70990139|NCT00300469|141488637|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect a 20% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%||||<0.001
70990140|NCT00300469|141488637|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect a 20% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%||||<0.001
70990141|NCT00300469|141488638|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide 99% power to detect a 13% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%||||0.005
70990142|NCT00300469|141488638|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide 99% power to detect a 13% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%||||0.010
70990143|NCT00300469|141488639|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect a 31% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
70990144|NCT00300469|141488639|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect a 31% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
70990145|NCT00436969|141488660|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.472||||0.696|TWO_SIDED|95.0|-8.888|5.943||The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||Anticipated VAS difference of 10 mm and SD of 25 mm indicated a sample size of 225 subjects in a 2:1 randomization would provide 80% power to detect a significant difference with a two-sided significance level of 5%. To account for a 15% dropout rate the sample size was increased to 270 subjects (180 Orthovisc, 90 control). The primary null hypothesis (Ho) no difference in VAS means at 6 months and the alternative hypothesis (Ha) was that Orthovisc (mean VAS) is superior to the control.||5.943|-8.888|0.696
70990146|NCT00436969|141488661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-15.6|15.1||||||Asymptotic 95% confidence interval for the treatment group difference (Orthovisc - Control) in proportions of responders was calculated. The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups at 6 months is unequal.||15.1|-15.6|
70990147|NCT00436969|141488662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3|||||TWO_SIDED|95.0|-19.7|9.1||||||Asymptotic 95% confidence interval for the treatment group difference (Orthovisc - Control) in proportions of responders was calculated. The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups at 6 months is unequal.||9.1|-19.7|
70990148|NCT00436969|141488663|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.87||||0.827|TWO_SIDED|95.0|-8.698|6.957||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||6.957|-8.698|0.827
70990149|NCT00436969|141488664|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.875||||0.392|TWO_SIDED|95.0|-9.472|3.723||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||3.723|-9.472|0.392
70990150|NCT00436969|141488665|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.932||||0.772|TWO_SIDED|95.0|-7.26|5.396||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||5.396|-7.260|0.772
70990151|NCT00436969|141488666|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.028||||0.707|TWO_SIDED|95.0|-4.338|6.393||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||6.393|-4.338|0.707
71039065|NCT01894230|141585784|EQUIVALENCE|Month 8, BMQ Necessity|Slope|0.248|STANDARD_ERROR_OF_MEAN|0.67||0.7235|TWO_SIDED||||||Regression, Linear|||||||0.7235
71039066|NCT01894230|141585784|EQUIVALENCE|Month 3, BMQ Concerns|Slope|-0.862|STANDARD_ERROR_OF_MEAN|0.686||0.2113|TWO_SIDED||||||Regression, Linear|||||||0.2113
71039067|NCT01894230|141585784|EQUIVALENCE|Month 8, BMQ Concerns|Slope|-1.0083|STANDARD_ERROR_OF_MEAN|0.737||0.1739|TWO_SIDED||||||Regression, Linear|||||||0.1739
71039068|NCT00396162|141585829|SUPERIORITY_OR_OTHER|||||||0.23|||||||t-test, 2 sided|||||||0.23
71039069|NCT00396162|141585830|SUPERIORITY_OR_OTHER|||||||0.31|||||||t-test, 2 sided|||||||.31
71039070|NCT02856594|141585833|SUPERIORITY||Odds Ratio (OR)|0.32||||0.029|TWO_SIDED|95.0|0.1|0.83|||Regression, Logistic|||||0.83|0.10|0.029
70990152|NCT00436969|141488667|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.82||||0.79|TWO_SIDED|95.0|-6.866|5.227||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||5.227|-6.866|0.790
70990153|NCT00436969|141488668|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.13||||0.685|TWO_SIDED|95.0|-4.341|6.001||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||6.001|-4.341|0.685
70990154|NCT00436969|141488669|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.317||||0.018|TWO_SIDED|95.0|1.249|13.386||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.||13.386|1.249|0.018
70990155|NCT00436969|141488670|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.361||||0.369|TWO_SIDED|95.0|-2.801|7.522||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||7.522|-2.801|0.369
70990156|NCT00436969|141488671|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.79||||0.41|TWO_SIDED|95.0|-9.441|3.861||The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||Anticipated VAS difference of 10 mm and SD of 25 mm indicated a sample size of 225 subjects in a 2:1 randomization would provide 80% power to detect a significant difference with a two-sided significance level of 5%. To account for a 15% dropout rate the sample size was increased to 270 subjects (180 Orthovisc, 90 control). The primary null hypothesis (Ho) no difference in VAS means at 6 months and the alternative hypothesis (Ha) was that Orthovisc (mean VAS) is superior to the control.||3.861|-9.441|0.410
70990157|NCT00436969|141488672|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.617||||0.379|TWO_SIDED|95.0|-3.226|8.46||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.||8.460|-3.226|0.379
70990158|NCT00436969|141488673|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.208||||0.409|TWO_SIDED|95.0|-7.455|3.039||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||3.039|-7.455|0.409
70990159|NCT00436969|141488674|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.558||||0.232|TWO_SIDED|95.0|-4.119|1.003||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.||1.003|-4.119|0.232
70990160|NCT00436969|141488675|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.228||||0.832|TWO_SIDED|95.0|-2.343|1.887||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||1.887|-2.343|0.832
71039071|NCT02856594|141585835|SUPERIORITY||Odds Ratio (OR)|0.96||||0.24|TWO_SIDED|95.0|0.89|1.03|||Regression, Linear|||||1.03|0.89|0.24
71039072|NCT01884844|141585846|SUPERIORITY|||||||0.89|||||||Fisher Exact|||||||0.89
71039073|NCT02854800|141585916|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||A separate t-test for each row was used to compare dropouts and completers.||||<0.05
71039074|NCT02854800|141585918|SUPERIORITY||||||<|0.05|||||||ANOVA|If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||One-way ANOVA was used to compare mean medication side effect ratings across the three arms/groups to determine whether one group had more severe symptoms that may have been related to study dropout.||||<0.05
71039075|NCT02854800|141585921|SUPERIORITY||||||<|0.05|||||||ANOVA|If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||Mixed ANOVA was used with Study Week (1-12) as the within-subjects, repeated-measures factor and Group as the between-subjects factor. If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||||<0.05
71039076|NCT02854800|141585922|SUPERIORITY||||||<|0.05|||||||ANOVA|If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||One-way ANOVA was used for each side effect rating with Group as the between-subjects factor. If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||||<0.05
70990161|NCT00436969|141488676|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.068||||0.957|TWO_SIDED|95.0|-2.396|2.532||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.||2.532|-2.396|0.957
70990162|NCT00436969|141488677|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.22||||0.267|TWO_SIDED|95.0|-0.937|3.378||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||3.378|-0.937|0.267
70990163|NCT00436969|141488678|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.19||||0.333|TWO_SIDED|95.0|-1.225|3.604||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.||3.604|-1.225|0.333
70990164|NCT00436969|141488679|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.771||||0.473|TWO_SIDED|95.0|-1.339|2.881||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||2.881|-1.339|0.473
70990165|NCT00436969|141488680|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.018||||0.988|TWO_SIDED|95.0|-2.314|2.278||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.||2.278|-2.314|0.988
70990166|NCT00436969|141488681|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.467||||0.671|TWO_SIDED|95.0|-1.692|2.627||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||2.627|-1.692|0.671
70990167|NCT04490265|141488682|SUPERIORITY||Cohen's d|0.33|||||TWO_SIDED|||||||||||||
70990168|NCT04490265|141488683|SUPERIORITY||Cohen's d|0.78|||||TWO_SIDED|||||||||||||
70990169|NCT04490265|141488688|SUPERIORITY||Cohen's d|0.14|||||TWO_SIDED|||||||||Belonging Subscale change from baseline to 12-weeks||||
70990170|NCT04490265|141488688|SUPERIORITY||Cohen's D|0.05|||||TWO_SIDED|||||||||Belonging subscale Baseline to 6-months||||
70990171|NCT04490265|141488688|SUPERIORITY||Cohen's D|0.6|||||TWO_SIDED|||||||||Change in Burdensome subscale Baseline to 12-weeks||||
70990172|NCT04490265|141488688|SUPERIORITY||Cohen's D|0.43|||||TWO_SIDED|||||||||Change in Burdensome subscale Baseline to 6 months||||
70990173|NCT04490265|141488689|SUPERIORITY||Cohen's D|0.07|||||TWO_SIDED|||||||||Baseline to 12-weeks||||
70990174|NCT04490265|141488689|SUPERIORITY||Cohen's D|0.13|||||TWO_SIDED|||||||||Baseline to 6-months||||
70990175|NCT04490265|141488690|SUPERIORITY||Cohen's d|0.6|||||TWO_SIDED|||||||||||||
70990176|NCT04490265|141488691|SUPERIORITY||Cohen's d|0.52|||||TWO_SIDED|||||||||||||
70990177|NCT04490265|141488692|SUPERIORITY||Cohen's d|0.21|||||TWO_SIDED|||||||||||||
70990178|NCT04490265|141488693|SUPERIORITY||Cohen's d|0.2|||||TWO_SIDED|||||||||||||
70990179|NCT04490265|141488694|SUPERIORITY||Cohen's d|0.66|||||TWO_SIDED|||||||||||||
70990180|NCT04490265|141488695|SUPERIORITY||cohen's d|0.38|||||TWO_SIDED|||||||||||||
70990181|NCT04490265|141488696|SUPERIORITY||Cohens d|0.47|||||TWO_SIDED|||||||||Severity||||
70990182|NCT04490265|141488696|SUPERIORITY||Cohens d|0.46|||||TWO_SIDED|||||||||interference||||
70990183|NCT04490265|141488697|SUPERIORITY||Cohens d|0.64|||||TWO_SIDED|||||||||Severity Subscale||||
70990184|NCT04490265|141488697|SUPERIORITY||Cohen's d|0.38|||||TWO_SIDED|||||||||Interference subscale||||
70990185|NCT02538666|141488765|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.3693|TWO_SIDED|95.0|0.75|1.12|||Stratified Log Rank|Stratified by response to ECOG PS (0vs1), gender (MvF), irradiation following chemotherapy (YorN) as entered in IVRS|based on stratified 3-arms Cox proportional hazard model|nivolumab + ipilimumab over placebo||1.12|0.75|0.3693
70990186|NCT02538666|141488766|SUPERIORITY||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.68|0.97|||||Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.|Global nivolumab over global placebo||0.97|0.68|
70990187|NCT02538666|141488766|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.53|1.66|||||Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.|China nivolumab over China Placebo||1.66|0.53|
70990188|NCT02538666|141488767|SUPERIORITY||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.94|1.36|||||Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.|Global nivolumab + ipilimumab over global nivolumab||1.36|0.94|
70990189|NCT02538666|141488767|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.56|1.79|||||Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.|China nivolumab + ipilimumab over China nivolumab||1.79|0.56|
70990190|NCT02538666|141488768|SUPERIORITY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.62|0.88|||||Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.|Global nivolumab + ipilimumab over global placebo||0.88|0.62|
70990191|NCT02538666|141488768|SUPERIORITY||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.55|0.79|||||Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.|Global nivolumab over global placebo||0.79|0.55|
70990192|NCT02538666|141488768|SUPERIORITY||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.94|1.35|||||Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.|Global nivolumab+ ipilimumab over nivolumab||1.35|0.94|
70990193|NCT02538666|141488768|SUPERIORITY||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.33|1.12|||||Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.|China Nivolumab + Ipilimumab over China placebo||1.12|0.33|
70990194|NCT02538666|141488768|SUPERIORITY||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.24|0.85|||||Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.|China Nivolumab over China placebo||0.85|0.24|
70990195|NCT02538666|141488768|SUPERIORITY||Hazard Ratio (HR)|1.34|||||TWO_SIDED|95.0|0.72|2.49|||||Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.|China Nivolumab + Ipilimumab over China Nivolumab||2.49|0.72|
70990196|NCT02538666|141488769|SUPERIORITY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.61|1.15|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥10 mutations/mb: Nivo+Ipi over placebo||1.15|0.61|
70990197|NCT02538666|141488769|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.55|1.04|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥10 mutations/mb: Nivo over placebo||1.04|0.55|
70990198|NCT02538666|141488769|SUPERIORITY||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.42|0.92|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥13 mutations/mb: Nivo+Ipi over placebo||0.92|0.42|
70990199|NCT02538666|141488769|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.44|0.93|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥13 mutations/mb: Nivo over placebo||0.93|0.44|
70990200|NCT02538666|141488769|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.68|1.21|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<10 mutations/mb: Nivo+Ipi over placebo||1.21|0.68|
70990201|NCT02538666|141488769|SUPERIORITY||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.66|1.18|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<10 mutations/mb: Nivo over placebo||1.18|0.66|
70990202|NCT02538666|141488769|SUPERIORITY||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.81|1.35|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<13 mutations/mb: Nivo+Ipi over placebo||1.35|0.81|
70990203|NCT02538666|141488769|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.72|1.2|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<13 mutations/mb: Nivo over placebo||1.20|0.72|
70990204|NCT02538666|141488770|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.58|1.09|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥10 mutations/mb: Nivo+Ipi over placebo||1.09|0.58|
70990205|NCT02538666|141488770|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.5|0.92|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥10 mutations/mb: Nivo over placebo||0.92|0.50|
70990206|NCT02538666|141488770|SUPERIORITY||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.5|1.07|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥13 mutations/mb: Nivo+Ipi over placebo||1.07|0.50|
70990207|NCT02538666|141488770|SUPERIORITY||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.46|0.95|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥13 mutations/mb: Nivo over placebo||0.95|0.46|
70990208|NCT02538666|141488770|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.54|0.96|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<10 mutations/mb: Nivo+Ipi over placebo||0.96|0.54|
70990209|NCT02538666|141488770|SUPERIORITY||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.49|0.89|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<10 mutations/mb: Nivo over placebo||0.89|0.49|
70990210|NCT02538666|141488770|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.6|1.01|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<13 mutations/mb: Nivo+Ipi over placebo||1.01|0.60|
70990211|NCT02538666|141488770|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.53|0.89|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<13 mutations/mb: Nivo over placebo||0.89|0.53|
70990212|NCT02538666|141488771|SUPERIORITY||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.76|1.09|||Stratified Log Rank||Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.|Global nivolumab + ipilimumab over Global placebo||1.09|0.76|
70990213|NCT02538666|141488771|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.52|1.67|||Stratified Log Rank||Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.|China nivolumab + ipilimumab over China placebo||1.67|0.52|
70990214|NCT03510663|141488782|SUPERIORITY||Least Squares Mean Difference|1.8|||||TWO_SIDED|90.0|-0.4|4.1||||||1 hour postdose||4.1|-0.4|
70990215|NCT03510663|141488782|SUPERIORITY||Least Squares Mean Difference|2.7|||||TWO_SIDED|90.0|0.4|4.9||||||1.5 hours postdose||4.9|0.4|
70990216|NCT03510663|141488782|SUPERIORITY||Least Squares Mean Difference|2.1|||||TWO_SIDED|90.0|-0.1|4.4||||||2 hours postdose||4.4|-0.1|
70990217|NCT03510663|141488782|SUPERIORITY||Least Squares Mean Difference|-0.5|||||TWO_SIDED|90.0|-2.8|1.7||||||3 hours postdose||1.7|-2.8|
70990218|NCT03510663|141488782|SUPERIORITY||Least Squares Mean Difference|-4.1|||||TWO_SIDED|90.0|-6.3|-1.8||||||4 hours postdose||-1.8|-6.3|
70990219|NCT03510663|141488782|SUPERIORITY||Least Squares Mean Difference|-3.5|||||TWO_SIDED|90.0|-5.7|-1.2||||||6 hours postdose||-1.2|-5.7|
70990220|NCT03510663|141488782|SUPERIORITY||Least Squares Mean Difference|-4.9|||||TWO_SIDED|90.0|-7.1|-2.6||||||12 hours postdose||-2.6|-7.1|
70990221|NCT03510663|141488782|SUPERIORITY||Least Squares Mean Difference|-0.9|||||TWO_SIDED|90.0|-3.1|1.4||||||24 hours postdose||1.4|-3.1|
70922826|NCT03833167|141336695|SUPERIORITY||Mean Difference (Final Values)|-2.89||||0.1874|TWO_SIDED|95.0|-7.19|1.42||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Extracapsular extension, Cortical bone invasion, and Prior systemic therapy.|Log Rank||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Extracapsular extension, Cortical bone invasion, and Prior systemic therapy.|||1.42|-7.19|0.1874
70922827|NCT02713126|141336789|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||||||0.770
70990222|NCT03510663|141488782|SUPERIORITY||Least Squares Mean Difference|0.9|||||TWO_SIDED|90.0|-1.4|3.1||||||1 hour postdose||3.1|-1.4|
70922828|NCT02713126|141336790|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|||||||0.087
70922829|NCT02713126|141336791|SUPERIORITY|||||||0.538|||||||t-test, 2 sided|||||||0.538
70922830|NCT02713126|141336792|SUPERIORITY|||||||0.708|||||||t-test, 2 sided|||||||0.708
70922831|NCT02713126|141336793|SUPERIORITY|||||||0.496|||||||t-test, 2 sided|||||||0.496
70990223|NCT03510663|141488782|SUPERIORITY||Least Squares Mean Difference|2.0|||||TWO_SIDED|90.0|-0.2|4.2||||||1.5 hours postdose||4.2|-0.2|
70990224|NCT03510663|141488782|SUPERIORITY||Least Squares Mean Difference|0.9|||||TWO_SIDED|90.0|-1.4|3.1||||||2 hours postdose||3.1|-1.4|
70922832|NCT00100698|141336794|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.0|STANDARD_ERROR_OF_MEAN|6.0||0.049|TWO_SIDED|95.0|-38.0|-0.5|||repeated measures mixed effects ANCOVA|||||-0.5|-38|0.049
70922833|NCT05450458|141336817|OTHER|This study assessed longitudinal effects within a single patient group. Statistical power was calculated using a significance level of 0.05, 80% power, and 60 patients, accounting for KOOS score variability over time. The Friedman test was applied with post hoc analyses (Conover and Bonferroni). Since treatments were not compared, no non-inferiority or equivalence margin was defined|Median Change Baseline to month 6|0.22|||<|0.001|TWO_SIDED|95.0|0.15|0.23||P-values were adjusted for multiple comparisons using the Bonferroni method, and the a priori threshold for statistical significance was set at 0.05.|Friedman Test|Post hoc pairwise comparisons were adjusted using the Bonferroni method, and the a priori significance level was set at 0.05|The value represents the intra-individual median KOOS improvement from baseline to month 6 after treatment. Changes were evaluated across time points within a single cohort.|The statistical analysis will use the Friedman test, as the Shapiro-Wilk test confirmed a non-normal distribution. Conover's post hoc test with Bonferroni correction will adjust for multiple comparisons. The null hypothesis states that hyaluronic acid injections with sorbitol do not significantly improve KOOS function and pain scores over time. A power analysis was performed to ensure an adequate sample size for detecting clinically meaningful differences.||0.23|0.15|<0.001
70990225|NCT03510663|141488782|SUPERIORITY||Least Squares Mean Difference|-1.6|||||TWO_SIDED|90.0|-3.8|0.7||||||3 hours postdose||0.7|-3.8|
70990226|NCT03510663|141488782|SUPERIORITY||Least Squares Mean Difference|-3.7|||||TWO_SIDED|90.0|-5.9|-1.5||||||4 hours postdose||-1.5|-5.9|
70990227|NCT03510663|141488782|SUPERIORITY||Least Squares Mean Difference|-2.3|||||TWO_SIDED|90.0|-4.6|-0.1||||||6 hours postdose||-0.1|-4.6|
70990228|NCT03510663|141488782|SUPERIORITY||Least Squares Mean Difference|-5.1|||||TWO_SIDED|90.0|-7.3|-2.8||||||12 hours postdose||-2.8|-7.3|
70990229|NCT03510663|141488782|SUPERIORITY||Least Squares Mean Difference|-0.2|||||TWO_SIDED|90.0|-2.4|2.1||||||24 hours postdose||2.1|-2.4|
70990230|NCT03510663|141488782|SUPERIORITY||Least Squares Mean Difference|10.8|||||TWO_SIDED|98.0|7.6|14.0||||||1 hour postdose||14.0|7.6|
70990231|NCT03510663|141488782|SUPERIORITY||Least Squares Mean Difference|10.2|||||TWO_SIDED|98.0|7.0|13.4||||||1.5 hours postdose||13.4|7.0|
70990232|NCT03510663|141488782|SUPERIORITY||Least Squares Mean Difference|11.2|||||TWO_SIDED|98.0|8.0|14.4||||||2 hours postdose||14.4|8.0|
70990233|NCT03510663|141488782|SUPERIORITY||Least Squares Mean Difference|11.5|||||TWO_SIDED|98.0|8.3|14.7||||||3 hours postdose||14.7|8.3|
70990234|NCT03510663|141488782|SUPERIORITY||Least Squares Mean Difference|9.7|||||TWO_SIDED|98.0|6.5|12.8||||||4 hours postdose||12.8|6.5|
70990235|NCT03510663|141488782|SUPERIORITY||Least Squares Mean Difference|10.4|||||TWO_SIDED|98.0|7.2|13.5||||||6 hours postdose||13.5|7.2|
70990236|NCT03510663|141488782|SUPERIORITY||Least Squares Mean Difference|7.3|||||TWO_SIDED|98.0|4.1|10.4||||||12 hours postdose||10.4|4.1|
70990237|NCT03510663|141488782|SUPERIORITY||Least Squares Mean Difference|7.0|||||TWO_SIDED|98.0|3.8|10.2||||||24 hours postdose||10.2|3.8|
70990238|NCT00777491|141488794|OTHER|There was no formal comparison of the two treatment arms.||||||||||||||||The confidence interval of the rate was calculated by Clopper-Pearson's exact binomial confidence intervals methods with one-sided type I error of 0.1. The study required 32 analyzable patients in each arm, which would warrant a 10% chance of observing a percentage of patients without distant metastasis by 3 years of less than 75% if the true rate was 86%. With the actual number of evaluable patients, the study instead warrants a 13-14% chance.|If the percentage of patients without distant metastasis by 3 years for either arm was greater than or equal to 75%, then it would be strongly considered as a potential arm in a subsequent phase III study, assuming treatment delivery and adverse events (AEs) were acceptable. If both arms met the criteria, then the treatment arm with less toxicity would be chosen.|||
70990239|NCT00777491|141488797|SUPERIORITY||Odds Ratio (OR)|0.493||||0.3|TWO_SIDED|95.0|0.129|1.881||Two-sided significance level of 0.05|Regression, Logistic|Univariate analysis|Reference arm = 5-FU and Cisplatin + BID Irradiation|||1.881|0.129|0.30
70990240|NCT00777491|141488798|SUPERIORITY||Odds Ratio (OR)|1.5||||0.75|TWO_SIDED|95.0|0.426|5.277||Two-sided significance level of 0.05|Regression, Logistic|Univariable analysis|Reference arm = 5-FU and Cisplatin + BID irradiation|||5.277|0.426|0.75
70990241|NCT03302416|141488807|SUPERIORITY|Baseline scan VT vs. Post-hydrocortisone scan VT||||||0.005|||||||Linear mixed model|||||||0.005
70990242|NCT00471445|141488811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.174|STANDARD_ERROR_OF_MEAN|0.19||0.363|TWO_SIDED|95.0|-0.548|0.201|||ANCOVA|||Tested at the two-sided 0.05 significance level.||0.201|-0.548|0.363
70990243|NCT02592629|141488831|EQUIVALENCE|ANOVA|||||<|0.05|||||||ANOVA|||||||<0.05
70990244|NCT01204658|141488833|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-LD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.61|2.57||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-LD vaccine vs Synflorix™ vaccine post dose 1 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 1 vaccination in the 10PP-LD Group minus Synflorix Group.||2.57|-2.61|0.003
70990245|NCT01204658|141488833|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-LD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.61|2.57||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-LD vaccine vs Synflorix™ vaccine post dose 2 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 2 vaccination in the 10PP-LD Group minus Synflorix Group.||2.57|-2.61|0.003
70990246|NCT01204658|141488833|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-LD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.62|2.57||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-LD vaccine vs Synflorix™ vaccine post dose 3 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 3 vaccination in the 10PP-LD Group minus Synflorix Group.||2.57|-2.62|0.003
70990247|NCT01204658|141488833|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-LD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.61|2.57||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-LD vaccine vs Synflorix™ vaccine across doses was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to vaccination, across doses, in the 10PP-LD Group minus Synflorix Group.||2.57|-2.61|0.003
70990248|NCT01204658|141488834|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-HD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.61|2.64||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-HD vaccine vs Synflorix™ vaccine post dose 1 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 1 vaccination in the 10PP-HD Group minus Synflorix Group.||2.64|-2.61|0.003
70990249|NCT01204658|141488834|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-HD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.61|2.64||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-HD vaccine vs Synflorix™ vaccine post dose 2 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 2 vaccination in the 10PP-HD Group minus Synflorix Group.||2.64|-2.61|0.003
70990250|NCT01204658|141488834|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-HD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.63|2.66||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-HD vaccine vs Synflorix™ vaccine post dose 3 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 3 vaccination in the 10PP-HD Group minus Synflorix Group.||2.66|-2.63|0.003
70990251|NCT01204658|141488834|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-HD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.61|2.64||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-HD vaccine vs Synflorix™ vaccine across doses was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to vaccination, across doses, in the 10PP-HD Group minus Synflorix Group.||2.64|-2.61|0.003
70990252|NCT04594239|141488897|SUPERIORITY||Difference in response rates|78.7|||||TWO_SIDED|95.0|66.3|85.6||||||||85.6|66.3|
70990253|NCT04594239|141488897|SUPERIORITY||Difference in response rates|85.4|||||TWO_SIDED|95.0|70.5|92.3||||||||92.3|70.5|
70990254|NCT04594239|141488897|SUPERIORITY||Difference in response rates|71.8|||||TWO_SIDED|95.0|55.2|82.5||||||||82.5|55.2|
70990255|NCT00681538|141488924|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-0.84||||0.0002|TWO_SIDED|95.0|-1.29|-0.4|||ANCOVA|||||-0.40|-1.29|0.0002
70922834|NCT05450458|141336818|OTHER|This study assessed longitudinal effects within a single patient group. Statistical power was calculated using a significance level of 0.05, 80% power, and 60 patients, accounting for IKDC score variability over time. The Friedman test was applied with post hoc analyses (Conover and Bonferroni). Since treatments were not compared, no non-inferiority or equivalence margin was defined|Median Baseline to Month 6|0.18||||0.01|TWO_SIDED|95.0|0.12|0.24||P-values were adjusted for multiple comparisons using the Bonferroni method, and the a priori threshold for statistical significance was set at 0.05.|Friedman Test|The overall p-value is unadjusted. The a priori significance level was set at 0.05 to robustly control the Type I error|This value represents the intra-individual median IKDC improvement from baseline to 6 months after treatment. The analysis was conducted within a single cohort without comparator arms.|The statistical analysis will use the Friedman test, as the Shapiro-Wilk test confirmed a non-normal distribution. Conover's post hoc test with Bonferroni correction will adjust for multiple comparisons. The null hypothesis states that hyaluronic acid injections with sorbitol do not significantly improve IKDC function and pain scores over time. A power analysis was performed to ensure an adequate sample size for detecting clinically meaningful differences.||0.24|0.12|0.01
70990256|NCT00681538|141488925|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.731||||0.0003|TWO_SIDED|95.0|1.589|4.694|||Regression, Logistic||Odds ratio\>1 indicates an improvement in favour of Sativex|30% responders||4.694|1.589|0.0003
70990257|NCT00681538|141488925|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.647||||0.0612|TWO_SIDED|95.0|0.977|2.777|||Regression, Logistic||Odds ratio\>1 indicates an improvement in favour of Sativex|50% Responders||2.777|0.977|0.0612
70990258|NCT00681538|141488926|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|-2.53||||0.0046|TWO_SIDED|95.0|-4.27|-0.79|||ANCOVA||A negative difference indicates an improvement in spasm frequency in favour of Sativex.|||-0.79|-4.27|0.0046
70990259|NCT00681538|141488927|SUPERIORITY_OR_OTHER_LEGACY||treatment difference|-0.88|||<|0.0001|TWO_SIDED|95.0|-1.25|-0.51|||ANCOVA||A negative difference indicates an improvement in sleep disruption in favour of Sativex.|||-0.51|-1.25|<0.0001
70990260|NCT00681538|141488928|SUPERIORITY_OR_OTHER_LEGACY||treatment difference|-1.75||||0.0939|TWO_SIDED|95.0|-3.8|0.3|||ANCOVA||A negative difference indicates an improvement in spasticity in favour of Sativex.|||0.30|-3.80|0.0939
70990261|NCT00681538|141488929|SUPERIORITY_OR_OTHER_LEGACY||treatment difference|-2.85||||0.56|TWO_SIDED|95.0|-12.75|7.04|||ANCOVA||A positive treatment difference indicates an improvement in favour of Sativex.|For Arm||7.04|-12.75|0.56
70990262|NCT00681538|141488929|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|0.04||||0.98|TWO_SIDED|95.0|-2.56|2.64|||ANCOVA||A positive treatment difference indicates an improvement in favour of Sativex.|For leg||2.64|-2.56|0.98
70990263|NCT00681538|141488930|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|-3.34||||0.0687|TWO_SIDED|95.0|-6.95|0.26|||ANCOVA||A negative treatment difference indicates an improvement in favour of Sativex.|||0.26|-6.95|0.0687
70990264|NCT00681538|141488931|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.703||||0.0234|TWO_SIDED|95.0|1.075|2.698|||Regression, Logistic||An odds ratio \> 1 indicates an improvement in favour of Sativex.|||2.698|1.075|0.0234
70990265|NCT00681538|141488932|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.4||||0.0053|TWO_SIDED|95.0|1.297|4.443|||Regression, Logistic||An odds ratio \> 1 indicates an improvement in favour of Sativex.|||4.443|1.297|0.0053
70990266|NCT00681538|141488933|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.792||||0.0613|TWO_SIDED|95.0|0.973|3.301|||Regression, Logistic||An odds ratio \> 1 indicates an improvement in favour of Sativex.|||3.301|0.973|0.0613
70990267|NCT00681538|141488934|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.958||||0.0045|TWO_SIDED|95.0|1.232|3.112|||Regression, Logistic||An odds ratio \> 1 indicates an improvement in favour of Sativex.|||3.112|1.232|0.0045
70990268|NCT00681538|141488935|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.02||||0.2836|TWO_SIDED|95.0|-0.02|0.07|||ANCOVA||A positive difference indicates an improvement in favour of Sativex.|For Health State Index||0.07|-0.02|0.2836
70990269|NCT00681538|141488935|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|1.24||||0.5644|TWO_SIDED|95.0|-3.01|5.5|||ANCOVA||A positive difference indicates an improvement in favour of Sativex.|Health Status VAS||5.50|-3.01|0.5644
70990270|NCT00681538|141488936|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-0.06||||0.9369|TWO_SIDED|95.0|-1.62|1.49|||ANCOVA||A negative difference indicates an improvement in depression in favour of Sativex.|||1.49|-1.62|0.9369
70990271|NCT00630812|141488937|SUPERIORITY||Mean Difference (Net)|54.14||||0.059|TWO_SIDED|95.0|-1.97|110.26|||Mixed Models Analysis|||||110.26|-1.97|0.059
70990272|NCT00630812|141488937|SUPERIORITY||Odds Ratio (OR)|1.69||||0.041|TWO_SIDED|95.0|1.02|2.8||Response defined as change of \>=100mL at week 26|Regression, Logistic|45.7% response on Mannitol 400mg, 35.5% on Control||||2.80|1.02|0.041
70990273|NCT00630812|141488938|SUPERIORITY||Mean Difference (Net)|43.49||||0.177|TWO_SIDED|95.0|-19.8|106.78|||Mixed Models Analysis|||||106.78|-19.8|0.177
70990274|NCT00630812|141488939|SUPERIORITY||Rate ratio|0.85||||0.52|TWO_SIDED|95.0|0.51|1.41|||Poisson regression|Offset of the natural logarithm of follow-up time||||1.41|0.51|0.520
70990275|NCT00630812|141488940|SUPERIORITY||Rate ratio|0.75||||0.328|TWO_SIDED|95.0|0.42|1.33|||Poisson regression|Offset of the natural logarithm of follow-up time||||1.33|0.42|0.328
70990276|NCT00630812|141488941|SUPERIORITY||Rate ratio|0.89||||0.368|TWO_SIDED|95.0|0.69|1.15|||Poisson regression|||||1.15|0.69|0.368
70990277|NCT00630812|141488942|SUPERIORITY||Mean Difference (Net)|2.42||||0.024|TWO_SIDED|95.0|0.33|4.51|||ANCOVA|||||4.51|0.33|0.024
70990278|NCT00630812|141488943|SUPERIORITY||Mean Difference (Net)|71.35||||0.022|TWO_SIDED|95.0|10.57|132.13|||Mixed Models Analysis|||||132.13|10.57|0.022
70990279|NCT00630812|141488944|SUPERIORITY||Mean Difference (Net)|34.34||||0.49|TWO_SIDED|95.0|-63.47|132.14|||Mixed Models Analysis|||||132.14|-63.47|0.49
70990280|NCT00630812|141488945|SUPERIORITY|||||||0.042|||||||Wilcoxon (Mann-Whitney)|||||||0.042
70990281|NCT01728584|141488946|SUPERIORITY_OR_OTHER||Difference in Least Squares (LS) Means|1.09||||0.026|TWO_SIDED|95.0|0.13|2.04|||ANCOVA|Analysis of covariance (ANCOVA) model included factors depth of NMB, level of pressure, surgeon and body mass index (BMI)|Difference is deep versus standard NMB|Primary hypothesis - deep NMB improves surgeon's overall satisfaction with the surgical conditions compared to standard NMB||2.04|0.13|0.026
70990282|NCT01728584|141488946|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.02|||<|0.001|TWO_SIDED|95.0|-3.99|-2.05|||ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is low versus standard pressure|||-2.05|-3.99|<0.001
70990283|NCT01728584|141488947|SUPERIORITY_OR_OTHER||Difference in Least Squares (LS) Means|3.66|||||TWO_SIDED|95.0|2.3|5.02|||||Difference is standard NMB/standard pressure versus standard NMB/low pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI||5.02|2.30|
70990284|NCT01728584|141488947|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.44|||||TWO_SIDED|95.0|-1.8|0.91|||||Difference is standard NMB/standard pressure versus deep NMB/standard pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI||0.91|-1.80|
70922835|NCT05450458|141336820|SUPERIORITY|This is a superiority analysis. Data normality was first assessed with the Shapiro-Wilk test, and due to non-normal distributions, a Wilcoxon Signed-Rank Test was applied to compare paired baseline and six-month IKDC score|Baseline to month 6|0.18||||0.001|TWO_SIDED|95.0|0.14|0.21||P-values from pairwise comparisons were adjusted using the Bonferroni method to control for multiple testing. The global p-value from the Friedman test was not adjusted. An a priori threshold for statistical significance was set at p \< 0.05|Wilcoxon Signed-Rank Test|Friedman test conducted with 3 degrees of freedom. Bonferroni correction applied in pairwise Wilcoxon post hoc comparisons.|Median IKDC improvement from baseline to 6 months in 22 athletes with elevated BMI (≥25). No comparator group was used. Confidence interval calculated via bootstrap (resampling with 1,000 iterations).|The analysis was conducted under the null hypothesis of no change in knee function across time. Data normality was assessed using the Shapiro-Wilk test. Changes across the four time points (baseline, 15 days, 3 months, and 6 months) were evaluated using the Friedman test. Pairwise comparisons were performed post hoc using the Wilcoxon Signed-Rank Test with Bonferroni correction at a 5% significance threshold.||0.21|0.14|0.001
70990285|NCT01728584|141488947|SUPERIORITY_OR_OTHER||Difference in LS Means|1.96|||||TWO_SIDED|95.0|0.57|3.36|||||Difference is standard NMB/standard pressure versus deep NMB/low pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI||3.36|0.57|
70922836|NCT05450458|141336820|SUPERIORITY|This is a superiority analysis. Data normality was first assessed with the Shapiro-Wilk test, and due to non-normal distributions, a Wilcoxon Signed-Rank Test was applied to compare paired baseline and six-month KOOS score|Baseline to Month 6|18.5|||<|0.001|TWO_SIDED|95.0|13.0|22.0||The p-values reported were not adjusted for multiple comparisons, and the a priori threshold for statistical significance was set at p \< 0.05|Wilcoxon Signed-Rank Test|Friedman test conducted with 3 degrees of freedom. Bonferroni correction applied in pairwise Wilcoxon post hoc comparisons.|Median KOOS improvement from baseline to 6 months in 22 athletes with elevated BMI. CI calculated via bootstrap resampling (1,000 iterations). No comparator group was involved.|The analysis was conducted under the null hypothesis of no change in knee function between baseline and six months. The study was designed with sufficient power to detect clinically meaningful improvements, with significance determined at a conventional level||22|13|<0.001
70922837|NCT04157348|141336822|SUPERIORITY||Difference in remission rates|0.0121||||0.8773|TWO_SIDED|95.0|-0.1411|0.1653|||Regression, Logistic|marginal standardization method|The difference of remission rates (Benralizumab - Mepolizumab) are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|||0.1653|-0.1411|0.8773
70922838|NCT04157348|141336823|SUPERIORITY||difference in remission rates|0.0544|||||TWO_SIDED|95.0|-0.0746|0.1834|||Regression, Logistic|marginal standardization method||||0.1834|-0.0746|
70922839|NCT04157348|141336824|SUPERIORITY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.72|2.4|||Proportional Odds Model||The odds ratio (Benralizumab vs. Mepolizumab) and its 95% CI are estimated with a proportional odds model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region. A \>1 odds ratio means Benralizumab is favored.|main remission||2.40|0.72|
70922840|NCT04157348|141336824|SUPERIORITY||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.55|2.29|||Proportional Odds Model||The odds ratio (Benralizumab vs. Mepolizumab) and its 95% CI are estimated with a proportional odds model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region. A \>1 odds ratio means Benralizumab is favored.|supportive remission||2.29|0.55|
70990286|NCT01728584|141488947|SUPERIORITY_OR_OTHER||Difference in LS Means|-4.1|||||TWO_SIDED|95.0|-5.42|-2.78|||||Difference is standard NMB/low pressure versus deep NMB/standard pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI||-2.78|-5.42|
70990287|NCT01728584|141488947|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.7|||||TWO_SIDED|95.0|-3.01|-0.38|||||Difference is standard NMB/low pressure versus deep NMB/low pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI||-0.38|-3.01|
70990288|NCT01728584|141488947|SUPERIORITY_OR_OTHER||Difference in LS Means|2.41|||||TWO_SIDED|95.0|1.08|3.74|||||Difference is deep NMB/standard pressure versus deep NMB/low pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI||3.74|1.08|
70990289|NCT01728584|141488948|SUPERIORITY_OR_OTHER||Difference in LS Means|0.35||||0.148|TWO_SIDED|95.0|-0.13|0.84|||ANOVA|Analysis of variance (ANOVA) model included factors depth of NMB, level of pressure, gender and surgeon|Difference is deep versus standard NMB|||0.84|-0.13|0.148
70922841|NCT04157348|141336825|SUPERIORITY||Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|0.74|2.44|||Proportional Odds Model||The odds ratio (Benralizumab vs. Mepolizumab) and its 95% CI are estimated with a proportional odds model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|sustained main remission||2.44|0.74|
70922842|NCT04157348|141336825|SUPERIORITY||Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|0.64|2.34|||Proportional Odds Model||The odds ratio (Benralizumab vs. Mepolizumab) and its 95% CI are estimated with a proportional odds model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region. A \>1 odds ratio means Benralizumab is favored.|sustained supportive remission||2.34|0.64|
70922843|NCT04157348|141336826|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.53|1.82|||Regression, Cox||The HR (Benralizumab vs. Mepolizumab) and 95% CI are estimated using a Cox regression model with Efron method to control for ties. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|relapse||1.82|0.53|
70922844|NCT04157348|141336827|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.56|1.9|||negative binomial model|marginal standardization method|The rate ratio (Benralizumab/Mepolizumab) and the corresponding 95% CI are calculated using a negative binomial model. The covariates in the model include treatment arm, baseline dose of prednisone, baseline BVAS and region.|relapse||1.90|0.56|
70922845|NCT04157348|141336829|SUPERIORITY||Odds Ratio (OR)|1.38|||||TWO_SIDED|95.0|0.75|2.54|||proportional odds model||The odds ratio (Benralizumab 30 mg vs. Mepolizumab 300 mg) and 95% CI are estimated using a proportional odds model. The covariates in the model include treatment arm, baseline dose of prednisone, baseline BVAS and region.|||2.54|0.75|
70922846|NCT04157348|141336830|SUPERIORITY||Odds Ratio (OR)|1.76|||||TWO_SIDED|95.0|0.96|3.22|||proportional odds model||The odds ratio (Benralizumab 30 mg vs. Mepolizumab 300 mg) for higher % reduction and 95% CI are estimated using a proportional odds model. The covariates in the model include treatment arm, baseline dose of prednisone, baseline BVAS and region.|||3.22|0.96|
70922847|NCT04157348|141336831|SUPERIORITY||difference in proportions|0.1079|||||TWO_SIDED|95.0|-0.0225|0.2383|||Regression, Logistic|marginal standardization method|The difference of proportions (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|\>=50% reduction||0.2383|-0.0225|
70922848|NCT04157348|141336831|SUPERIORITY||difference in proportions|0.1569|||||TWO_SIDED|95.0|0.0067|0.3017|||Regression, Logistic|marginal standardization method|The difference of proportions (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|100% reduction||0.3017|0.0067|
70922849|NCT04157348|141336831|SUPERIORITY||difference in proportions|-0.0068|||||TWO_SIDED|95.0|-0.1555|0.1418|||Regression, Logistic|marginal standardization method|The difference of proportions (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|OCS dose \<=4 mg/day||0.1418|-0.1555|
70922850|NCT04157348|141336832|SUPERIORITY||difference in response rates|0.046|||||TWO_SIDED|95.0|-0.0422|0.1341|||Regression, Logistic|marginal standardization method|The difference of response rates (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|any clinical response-definition 1||0.1341|-0.0422|
70990290|NCT01728584|141488948|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.17||||0.494|TWO_SIDED|95.0|-0.67|0.33||To control for multiple testing, this difference was formally tested only if comparison of surgeon's overall satisfaction with surgical conditions for deep versus standard NMB was significant at the 5% level, with greater satisfaction for deep NMB.|ANOVA|ANOVA model included factors depth of NMB, level of pressure, gender and surgeon|Difference is low versus standard pressure|Key secondary hypothesis - low insufflation pressure improves overall average pain score in first 24 hours compared to standard insufflation pressure||0.33|-0.67|0.494
70990291|NCT01728584|141488949|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2|||||TWO_SIDED|95.0|-0.92|0.52|||||Difference is standard NMB/standard pressure versus standard NMB/low pressure|ANOVA model included factors treatment group, gender and surgeon||0.52|-0.92|
70990292|NCT01728584|141488949|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.65|||||TWO_SIDED|95.0|-1.27|-0.02|||||Difference is standard NMB/standard pressure versus deep NMB/standard pressure|ANOVA model included factors treatment group, gender and surgeon||-0.02|-1.27|
70990293|NCT01728584|141488949|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.15|||||TWO_SIDED|95.0|-0.84|0.53|||||Difference is standard NMB/standard pressure versus deep NMB/low pressure|ANOVA model included factors treatment group, gender and surgeon||0.53|-0.84|
70990294|NCT01728584|141488949|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.45|||||TWO_SIDED|95.0|-1.15|0.26|||||Difference is standard NMB/low pressure versus deep NMB/standard pressure|ANOVA model included factors treatment group, gender and surgeon||0.26|-1.15|
70990295|NCT01728584|141488949|SUPERIORITY_OR_OTHER||Difference in LS Means|0.05|||||TWO_SIDED|95.0|-0.69|0.78|||||Difference is standard NMB/low pressure versus deep NMB/low pressure|ANOVA model included factors treatment group, gender and surgeon||0.78|-0.69|
70990296|NCT01728584|141488949|SUPERIORITY_OR_OTHER||Difference in LS Means|0.49|||||TWO_SIDED|95.0|-0.17|1.16|||||Difference is deep NMB/standard pressure versus deep NMB/low pressure|ANOVA model included factors treatment group, gender and surgeon||1.16|-0.17|
70990297|NCT01728584|141488950|SUPERIORITY_OR_OTHER||Difference in LS Means|0.91||||0.063|TWO_SIDED|95.0|-0.05|1.87||Not controlled for multiple testing|ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is deep versus standard NMB|||1.87|-0.05|0.063
70990298|NCT01728584|141488951|SUPERIORITY_OR_OTHER||Difference in LS Means|0.82||||0.004|TWO_SIDED|95.0|0.27|1.37||Not controlled for multiple testing|ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is deep versus standard NMB|||1.37|0.27|0.004
70990299|NCT01728584|141488952|SUPERIORITY_OR_OTHER||Difference in LS Means|1.12||||0.006|TWO_SIDED|95.0|0.32|1.92||Not controlled for multiple testing|ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is deep versus standard NMB|||1.92|0.32|0.006
70990300|NCT01728584|141488953|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.61||||0.073|TWO_SIDED|95.0|-1.27|0.06||Not controlled for multiple testing|ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is deep versus standard NMB|||0.06|-1.27|0.073
70990301|NCT01728584|141488954|SUPERIORITY_OR_OTHER||Difference in LS Means|0.74||||0.009|TWO_SIDED|95.0|0.19|1.28||Not controlled for multiple testing|ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is deep versus standard NMB|||1.28|0.19|0.009
70990302|NCT03207022|141488968|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70990303|NCT03207022|141488969|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
70990304|NCT03207022|141488970|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70990305|NCT03656926|141488974|SUPERIORITY|Estimates are from a Linear Mixed Model on the response variable change from baseline in FEV1 with factors for time splines, treatment, the interactions of time splines by treatment, baseline FEV1, the interactions of time splines with baseline FEV1, region (North America vs all other countries together), age (\<55 versus \>=55 years), use of azithromycin at randomization, and time as random effect.|least square mean difference|-0.028||||0.6639|TWO_SIDED|95.0|-0.16|0.104||This is a 1-side p value.|Mixed Models Analysis|||V9 - week 48||0.104|-0.160|0.6639
70990306|NCT01253044|141489028|SUPERIORITY_OR_OTHER|||||||0.912|TWO_SIDED||||||MMRM|||||||.912
70990307|NCT01253044|141489029|SUPERIORITY_OR_OTHER|||||||0.273|TWO_SIDED||||||MMRM|||||||.273
70990308|NCT00905307|141489032|SUPERIORITY_OR_OTHER||Treatment difference|-4.7||||0.2846|TWO_SIDED|95.0|-10.2|0.82||The Hochberg procedure using two-sided alpha of 0.05 was applied to control the type I error rate at 0.05 level (two-sided) due to multiple comparisons.|ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.82|-10.2|0.2846
70990309|NCT00905307|141489032|SUPERIORITY_OR_OTHER||Treatment difference|-1.44||||0.6066|TWO_SIDED|95.0|-6.96|4.07||The Hochberg procedure using two-sided alpha of 0.05 was applied to control the type I error rate at 0.05 level (two-sided) due to multiple comparisons.|ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||4.07|-6.96|0.6066
70990310|NCT00905307|141489032|SUPERIORITY_OR_OTHER||Treatment difference|-3.86||||0.3293|TWO_SIDED|95.0|-9.32|1.59||The Hochberg procedure using two-sided alpha of 0.05 was applied to control the type I error rate at 0.05 level (two-sided) due to multiple comparisons.|ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||1.59|-9.32|0.3293
70990311|NCT00905307|141489032|SUPERIORITY_OR_OTHER||Treatment difference|4.62||||0.2263|TWO_SIDED|95.0|-2.89|12.12|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||12.12|-2.89|0.2263
70990312|NCT00905307|141489032|SUPERIORITY_OR_OTHER||Treatment difference|-3.64||||0.3074|TWO_SIDED|95.0|-10.7|3.38|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||||3.38|-10.7|0.3074
70990313|NCT00905307|141489033|SUPERIORITY_OR_OTHER||Treatment difference|1.61||||0.1807|TWO_SIDED|95.0|-0.75|3.97|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS positive subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||3.97|-0.75|0.1807
70990314|NCT00905307|141489033|SUPERIORITY_OR_OTHER||Treatment difference|-1.41||||0.1313|TWO_SIDED|95.0|-3.24|0.42|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS positive subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.42|-3.24|0.1313
70990315|NCT00905307|141489033|SUPERIORITY_OR_OTHER||Treatment difference|-0.13||||0.8879|TWO_SIDED|95.0|-1.96|1.69|||ANCOVA|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS positive subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||1.69|-1.96|0.8879
70922851|NCT04157348|141336832|SUPERIORITY||difference in response rates|0.079|||||TWO_SIDED|95.0|-0.0732|0.2312|||Regression, Logistic|marginal standardization method|The difference of response rates (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|complete response-definition 1||0.2312|-0.0732|
70990316|NCT00905307|141489033|SUPERIORITY_OR_OTHER||Treatment difference|-1.24||||0.1764|TWO_SIDED|95.0|-3.05|0.56|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS positive subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.56|-3.05|0.1764
70990317|NCT00905307|141489033|SUPERIORITY_OR_OTHER||Treatment difference|-1.79||||0.1111|TWO_SIDED|95.0|-4.0|0.42|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS positive subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.42|-4.00|0.1111
70990318|NCT00905307|141489034|SUPERIORITY_OR_OTHER||Treatment difference|1.0||||0.2896|TWO_SIDED|95.0|-0.86|2.86|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS negative subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||2.86|-0.86|0.2896
70990319|NCT00905307|141489034|SUPERIORITY_OR_OTHER||Treatment difference|-0.61||||0.3701|TWO_SIDED|95.0|-1.94|0.72|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS negative subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.72|-1.94|0.3701
70990320|NCT00905307|141489034|SUPERIORITY_OR_OTHER||Treatment difference|-0.35||||0.6074|TWO_SIDED|95.0|-1.69|0.99|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS negative subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.99|-1.69|0.6074
70990321|NCT00905307|141489034|SUPERIORITY_OR_OTHER||Treatment difference|-0.73||||0.2777|TWO_SIDED|95.0|-2.05|0.59|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS negative subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||0.59|-2.05|0.2777
70990322|NCT00905307|141489034|SUPERIORITY_OR_OTHER||Treatment difference|-0.15||||0.8611|TWO_SIDED|95.0|-1.9|1.59|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS negative subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.59|-1.90|0.8611
70990323|NCT00905307|141489035|SUPERIORITY_OR_OTHER||Treatment difference|-2.36||||0.3726|TWO_SIDED|95.0|-7.57|2.85|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PSP score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||2.85|-7.57|0.3726
70990324|NCT00905307|141489035|SUPERIORITY_OR_OTHER||Treatment difference|3.8||||0.0664|TWO_SIDED|95.0|-0.26|7.85|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PSP score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||7.85|-0.26|0.0664
70990325|NCT00905307|141489035|SUPERIORITY_OR_OTHER||Treatment difference|2.2||||0.2944|TWO_SIDED|95.0|-1.92|6.32|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||6.32|-1.92|0.2944
70990326|NCT00905307|141489035|SUPERIORITY_OR_OTHER||Treatment difference|3.86||||0.0596|TWO_SIDED|95.0|-0.16|7.89|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||7.89|-0.16|0.0596
71039077|NCT02854800|141585923|SUPERIORITY||||||<|0.05|||||||ANOVA|If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||Data were analyzed via mixed ANOVA whereby Study Visit (1-4) was the repeated-measures factor and Group (weekly, biweekly, monthly) was the between-subjects factor. If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||||<0.05
71039078|NCT02854800|141585925|SUPERIORITY||||||<|0.05|||||||ANOVA|If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||Data were analyzed via mixed ANOVA whereby Study Visit (1-4) was the repeated-measures factor and Group (weekly, biweekly, monthly) was the between-subjects factor. If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||||<0.05
71039079|NCT02627963|141585940|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0165|TWO_SIDED|95.0|0.56|0.94||A one-sided, log-rank test stratified for IMDC risk category and prior therapy (two VEGFR TKIs vs. a checkpoint inhibitor plus a VEGFR TKI vs. a VEGFR TKI plus any other systemic agent) at a significance level of α = 0.025 was used.|Log Rank|||||0.94|0.56|0.0165
70990327|NCT00905307|141489035|SUPERIORITY_OR_OTHER||Treatment difference|3.25||||0.1819|TWO_SIDED|95.0|-1.53|8.03|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||8.03|-1.53|0.1819
70990328|NCT00905307|141489036|SUPERIORITY_OR_OTHER||Treatment difference|0.38||||0.0685|TWO_SIDED|95.0|-0.03|0.79|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in CGI-S score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||0.79|-0.03|0.0685
70990329|NCT00905307|141489036|SUPERIORITY_OR_OTHER||Treatment difference|-0.28||||0.0989|TWO_SIDED|95.0|-0.6|0.05|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||0.05|-0.60|0.0989
70990330|NCT00905307|141489036|SUPERIORITY_OR_OTHER||Treatment difference|-0.04||||0.8006|TWO_SIDED|95.0|-0.37|0.28|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.28|-0.37|0.8006
70990331|NCT00905307|141489036|SUPERIORITY_OR_OTHER||Treatment difference|-0.28||||0.0898|TWO_SIDED|95.0|-0.6|0.04|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||0.04|-0.60|0.0898
70990332|NCT00905307|141489036|SUPERIORITY_OR_OTHER||Treatment difference|-0.21||||0.2851|TWO_SIDED|95.0|-0.59|0.18|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||0.18|-0.59|0.2851
70990333|NCT00905307|141489037|SUPERIORITY_OR_OTHER|||||||0.4008|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel (CMH) row mean scores differ test controlling for study center was applied to mean CGI-I score||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||||0.4008
70990334|NCT00905307|141489037|SUPERIORITY_OR_OTHER|||||||0.1117|||||||Cochran-Mantel-Haenszel|The CMH row mean scores differ test controlling for study center was applied to mean CGI-I score||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||||0.1117
70990335|NCT00905307|141489037|SUPERIORITY_OR_OTHER|||||||0.2739|||||||Cochran-Mantel-Haenszel|The CMH row mean scores differ test controlling for study center was applied to mean CGI-I score||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||||0.2739
70990336|NCT00905307|141489037|SUPERIORITY_OR_OTHER|||||||0.1045|||||||Cochran-Mantel-Haenszel|The CMH row mean scores differ test controlling for study center was applied to mean CGI-I score||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||||0.1045
70990337|NCT00905307|141489037|SUPERIORITY_OR_OTHER|||||||0.1149|||||||Cochran-Mantel-Haenszel|The CMH row mean scores differ test controlling for study center was applied to mean CGI-I score||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||||0.1149
71039080|NCT02627963|141585941|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8174|TWO_SIDED|95.0|0.75|1.25|||Log Rank|||||1.25|0.75|0.8174
71039081|NCT05053360|141585971|SUPERIORITY||Odds Ratio (OR)|2.87||||0.019|TWO_SIDED|95.0|1.19|6.93|||Regression, Logistic|||HIGH PAIN = score over 6 on a 0-10 pain scale (higher number indicating higher pain)||6.93|1.19|.019
71039082|NCT05053360|141585972|SUPERIORITY||Mean Difference (Final Values)|-2.28||||0.0002|TWO_SIDED|95.0|-3.47|-1.09|||ANCOVA|||||-1.09|-3.47|.0002
71039083|NCT03807440|141585990|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<.0001
71039084|NCT03807440|141585991|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
71039085|NCT03807440|141585992|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<.0001
71039086|NCT03807440|141585993|OTHER|||||||0.8071|||||||Chi-squared|||||||0.8071
71039087|NCT03807440|141585993|OTHER|||||||0.764|||||||Fisher Exact|||||||0.7640
71039088|NCT03807440|141585994|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<.0001
71039089|NCT03807440|141585995|OTHER|||||||0.0042|||||||Chi-squared|||||||0.0042
71039090|NCT03807440|141585996|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<.0001
71039091|NCT03807440|141585997|OTHER|||||||0.399|||||||Chi-squared|||||||0.3990
71039092|NCT03807440|141585997|OTHER|||||||0.3842|||||||Fisher Exact|||||||0.3842
71039093|NCT03807440|141585998|OTHER|||||||0.0605|||||||Kruskal-Wallis|||||||0.0605
70922852|NCT04157348|141336833|SUPERIORITY||difference in remission rates|0.0554|||||TWO_SIDED|95.0|-0.093|0.2037|||Regression, Logistic|marginal standardization method|The difference of remission rates (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|main remission||0.2037|-0.0930|
70922853|NCT04157348|141336833|SUPERIORITY||difference in remission rates|0.0467|||||TWO_SIDED|95.0|-0.1021|0.1956|||Regression, Logistic|marginal standardization method|The difference of remission rates (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|supportive remission||0.1956|-0.1021|
70922854|NCT00262301|141336856|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Log Rank|||||||0.003
70922855|NCT00262301|141336857|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Log Rank|||||||0.005
70922856|NCT00715884|141336864|NON_INFERIORITY_OR_EQUIVALENCE|The null inferiority hypothesis was that the upper limit of the 95% confidence interval is equal or greater than the non-inferiority margin 5%. The alternative non-inferiority hypothesis for this study assumed that the upper limit of the 95% confidence interval would be less than the non-inferiority margin 5%.|Difference between TLF rates|2.58|||||ONE_SIDED|95.0||5.55||In the CYPHER® ELITE™ arm the TLF rate was 5.36% (23/429) compared with 2.78% (6/216) in the CYPHER® Bx VELOCITY® arm, a difference in rates of 2.58%, upper limit of 95% two sided confidence interval of 5.55%.||||Sample sizes of 1,061 from the ELITE™ group and 531 from the CYPHER® group were planned to achieve 90 percent power at a 2.5 percent significance level using an one-sided equivalence test, assuming a 10 percent TLF rate in each group and the maximum allowable rate difference between the groups being 5 percent. The total sample size was increased to 1,770 patients to account for an approximately 90 percent compliance to clinical follow-up.||5.55||
70922857|NCT00715884|141336865|SUPERIORITY_OR_OTHER||Difference between event rates|-0.4||||0.549|TWO_SIDED|95.0|-1.3|1.0|||Fisher Exact|||||1.0|-1.3|0.549
70922858|NCT00715884|141336866|SUPERIORITY_OR_OTHER||Difference between event rates|13.8|||<|0.001|TWO_SIDED|95.0|9.2|18.9|||Fisher Exact|||||18.9|9.2|<.001
70922859|NCT00715884|141336867|SUPERIORITY_OR_OTHER||Difference between event rates|0.7||||0.724|TWO_SIDED|95.0|-2.2|4.2|||Fisher Exact|||||4.2|-2.2|0.724
70922860|NCT00715884|141336868|SUPERIORITY_OR_OTHER||Difference between event rates|-1.3||||0.407|TWO_SIDED|95.0|-3.5|1.4|||Fisher Exact|||||1.4|-3.5|0.407
70922861|NCT00715884|141336869|SUPERIORITY_OR_OTHER||Difference between event rates|2.11||||0.203|TWO_SIDED|95.0|-0.84|4.48|||Fisher Exact|||||4.48|-0.84|0.203
70922862|NCT00715884|141336870|SUPERIORITY_OR_OTHER||Difference between event rates|2.35||||0.22|TWO_SIDED|95.0|-1.24|5.28|||Fisher Exact|||||5.28|-1.24|0.22
70922863|NCT00715884|141336871|SUPERIORITY_OR_OTHER||Difference between event rates|2.83||||0.166|TWO_SIDED|95.0|-1.28|6.26|||Fisher Exact|||||6.26|-1.28|0.166
70990338|NCT00905307|141489038|SUPERIORITY_OR_OTHER||Relative Risk|0.89||||0.62|TWO_SIDED|95.0|0.57|1.4|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center will be applied to the analysis of response rate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.40|0.57|0.6200
70990339|NCT00905307|141489038|SUPERIORITY_OR_OTHER||Relative Risk|1.19||||0.1501|TWO_SIDED|95.0|0.95|1.48|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center will be applied to the analysis of response rate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.48|0.95|0.1501
70990340|NCT00905307|141489038|SUPERIORITY_OR_OTHER||Relative Risk|0.91||||0.5271|TWO_SIDED|95.0|0.66|1.25|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center will be applied to the analysis of response rate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.25|0.66|0.5271
70990341|NCT00905307|141489038|SUPERIORITY_OR_OTHER||Relative Risk|1.02||||0.867|TWO_SIDED|95.0|0.78|1.34|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center will be applied to the analysis of response rate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||1.34|0.78|0.8670
70922864|NCT00715884|141336872|SUPERIORITY_OR_OTHER||Difference between event rates|2.59||||0.2|TWO_SIDED|95.0|-1.35|5.85|||Fisher Exact|||||5.85|-1.35|0.200
71039094|NCT03807440|141585999|OTHER|||||||0.6329|||||||Chi-squared|||||||0.6329
70922865|NCT00715884|141336873|SUPERIORITY_OR_OTHER||Difference between event rates|11.56||||0.14|TWO_SIDED|95.0|-3.73|24.64|||Fisher Exact|||||24.64|-3.73|0.140
70922866|NCT00715884|141336874|SUPERIORITY_OR_OTHER||Difference between event rates|5.17||||0.17|TWO_SIDED|95.0|-2.03|10.83|||Fisher Exact|||||10.83|-2.03|0.170
70922867|NCT00715884|141336875|SUPERIORITY_OR_OTHER||Difference between event rates|0.24||||1|TWO_SIDED|95.0|-5.61|5.43|||Fisher Exact|||||5.43|-5.61|1.0
70922868|NCT00715884|141336876|SUPERIORITY_OR_OTHER||Difference between event rates|0.24||||1|TWO_SIDED|95.0|-1.92|1.63|||Fisher Exact|||||1.63|-1.92|1.0
70922869|NCT00715884|141336877|SUPERIORITY_OR_OTHER||Difference between event rates|0.49||||0.801|TWO_SIDED|95.0|-2.73|2.91|||Fisher Exact|||||2.91|-2.73|0.801
70922870|NCT00715884|141336878|SUPERIORITY_OR_OTHER||Difference between event rates|-0.92||||0.341|TWO_SIDED|95.0|-3.56|0.6|||Fisher Exact|||||0.60|-3.56|0.341
70922871|NCT00715884|141336879|SUPERIORITY_OR_OTHER||Difference between event rates|0.0||||1|TWO_SIDED|95.0|-2.14|1.28|||Fisher Exact|||||1.28|-2.14|1.00
70922872|NCT00715884|141336880|SUPERIORITY_OR_OTHER||Difference between event rates|0.47||||0.668|TWO_SIDED|95.0|-1.72|1.96|||Fisher Exact|||||1.96|-1.72|0.668
71039095|NCT03807440|141585999|OTHER|||||||0.7181|||||||Fisher Exact|||||||0.7181
71039096|NCT03807440|141586000|OTHER|||||||0.5233|||||||Kruskal-Wallis|||||||0.5233
70990342|NCT00905307|141489038|SUPERIORITY_OR_OTHER||Relative Risk|1.15||||0.3892|TWO_SIDED|95.0|0.85|1.56|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center will be applied to the analysis of response rate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.56|0.85|0.3892
70990343|NCT00905307|141489039|SUPERIORITY_OR_OTHER||Relative risk|1.06||||0.854|TWO_SIDED|95.0|0.59|1.88||Derived using CMH test stratified by trial center.|Cochran-Mantel-Haenszel|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.88|0.59|0.8540
70990344|NCT00905307|141489039|SUPERIORITY_OR_OTHER||Relative Risk|0.82||||0.4492|TWO_SIDED|95.0|0.49|1.38||Derived using CMH test stratified by trial center.|Cochran-Mantel-Haenszel|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||1.38|0.49|0.4492
70990345|NCT00905307|141489039|SUPERIORITY_OR_OTHER||Relative Risk|0.67||||0.1854|TWO_SIDED|95.0|0.36|1.23||Derived using CMH test stratified by trial center.|Cochran-Mantel-Haenszel|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.23|0.36|0.1854
70990346|NCT00905307|141489039|SUPERIORITY_OR_OTHER||Relative Risk|0.61||||0.0946|TWO_SIDED|95.0|0.33|1.1||Derived using CMH test stratified by trial center.|Cochran-Mantel-Haenszel|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.10|0.33|0.0946
70990347|NCT00905307|141489039|SUPERIORITY_OR_OTHER||Relative Risk|0.63||||0.2133||95.0|0.3|1.34||Derived using CMH test stratified by trial center.|Cochran-Mantel-Haenszel|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.34|0.30|0.2133
70990348|NCT03280550|141489044|SUPERIORITY||Difference in Least Squares Means|-1.14|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.59|-0.69||Tested at the two-sided 0.05 significance level. There was no adjustment for multiplicity for the co-primary outcome measures.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NPS, treatment and baseline NPS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The primary analysis tested the null hypothesis that no treatment group difference existed for change from baseline in NPS at Week 24. As NPS and NCS are co-primary outcome measures, both null hypotheses for NPS and NCS must be rejected, with parameter estimates indicating a benefit of omalizumab over placebo, for the study to be deemed positive.||-0.69|-1.59|<0.0001
70990349|NCT03280550|141489045|SUPERIORITY||Difference in Least Squares Means|-0.55|STANDARD_ERROR_OF_MEAN|0.15||0.0004|TWO_SIDED|95.0|-0.84|-0.25||Tested at the two-sided 0.05 significance level. There was no adjustment for multiplicity for the co-primary outcome measures.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NCS, treatment and baseline NCS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The primary analysis tested the null hypothesis that no treatment group difference existed for change from baseline in NCS at Week 24. As NPS and NCS are co-primary outcome measures, both null hypotheses for NPS and NCS must be rejected, with parameter estimates indicating a benefit of omalizumab over placebo, for the study to be deemed positive.||-0.25|-0.84|0.0004
70990350|NCT03280550|141489046|SUPERIORITY||Difference in Least Squares Means|-0.33|STANDARD_ERROR_OF_MEAN|0.14||0.0161|TWO_SIDED|95.0|-0.6|-0.06||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline SSS, treatment and baseline SSS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Sense of Smell Score (SSS) at Week 24.||-0.06|-0.60|0.0161
70990351|NCT03280550|141489047|SUPERIORITY||Difference in Least Squares Means|-0.56|STANDARD_ERROR_OF_MEAN|0.14||0.0001|TWO_SIDED|95.0|-0.84|-0.28||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline PRS, treatment and baseline PRS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Posterior Rhinorrhea Score (PRS) at Week 24.||-0.28|-0.84|0.0001
70990352|NCT03280550|141489048|SUPERIORITY||Difference in Least Squares Means|-1.01|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.43|-0.6||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NPS, treatment and baseline NPS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the NPS at Week 16.||-0.60|-1.43|<0.0001
71039097|NCT03807440|141586002|OTHER|||||||0.3662|||||||Kruskal-Wallis|||||||0.3662
71039098|NCT03807440|141586003|OTHER|||||||0.511|||||||Kruskal-Wallis|||||||0.5110
71039099|NCT03807440|141586004|OTHER|||||||0.0921|||||||Kruskal-Wallis|||||||0.0921
71039100|NCT03807440|141586005|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<.0001
71039101|NCT03807440|141586006|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
71039102|NCT03807440|141586007|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<.0001
71039103|NCT03807440|141586008|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
71039104|NCT03807440|141586009|OTHER|||||||0.3201|||||||Kruskal-Wallis|||||||0.3201
70990353|NCT03280550|141489049|SUPERIORITY||Difference in Least Squares Means|-0.57|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.83|-0.31||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NCS, treatment and baseline NCS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily NCS at Week 16.||-0.31|-0.83|<0.0001
70990354|NCT03280550|141489050|SUPERIORITY||Difference in Least Squares Means|-16.12|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-21.86|-10.38||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the SNOT-22 score at Week 24.||-10.38|-21.86|<0.0001
70990355|NCT03280550|141489051|SUPERIORITY||Difference in Least Squares Means|-0.43|STANDARD_ERROR_OF_MEAN|0.14||0.0023|TWO_SIDED|95.0|-0.7|-0.16||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline ARS, treatment and baseline ARS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Anterior Rhinorrhea Score (ARS) at Week 24.||-0.16|-0.70|0.0023
70990356|NCT03280550|141489052|SUPERIORITY||Odds Ratio (OR)|0.61||||0.6716|TWO_SIDED|95.0|0.05|5.51||Tested at the two-sided 0.05 significance level.|Fisher Exact|Unadjusted|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for requirement of rescue medication through Week 24.||5.51|0.05|0.6716
70990357|NCT03280550|141489053|SUPERIORITY||Odds Ratio (OR)|0.0||||0.4815|TWO_SIDED|95.0|0.0|17.64||Tested at the two-sided 0.05 significance level.|Fisher Exact|Unadjusted|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for having had surgery for nasal polyps through Week 24.||17.64|0.00|0.4815
70990358|NCT03280550|141489054|SUPERIORITY||Odds Ratio (OR)|3.71||||0.0492|TWO_SIDED|95.0|1.0|13.71|||Wald Chi-Square|Adjusted for Baseline AQLQ, geographic region, and aspirin sensitivity status.|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for number of participants with a change from baseline in AQLQ score of ≥0.5 at Week 24.||13.71|1.00|0.0492
70990359|NCT03280550|141489055|SUPERIORITY||Odds Ratio (OR)|0.61||||0.6716|TWO_SIDED|95.0|0.05|5.51||Tested at the two-sided 0.05 significance level.|Fisher Exact|Unadjusted|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for requirement of rescue treatment through Week 24.||5.51|0.05|0.6716
70990360|NCT03280550|141489056|SUPERIORITY||Odds Ratio (OR)|6.25||||0.0209|TWO_SIDED|95.0|1.32|29.6||Tested at the two-sided 0.05 significance level.|Wald Chi-Square|Adjusted for geographic region and asthma/aspirin sensitivity comorbidity status.|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in reduction in the need for surgery for nasal polyps by Week 24.||29.60|1.32|0.0209
70990361|NCT03280550|141489057|SUPERIORITY||Difference in Least Squares Means|-1.91|STANDARD_ERROR_OF_MEAN|0.48||0.0001|TWO_SIDED|95.0|-2.85|-0.96||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline TNSS, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Total Nasal Symptom Score (TNSS) at Week 24.||-0.96|-2.85|0.0001
70990362|NCT03280550|141489058|SUPERIORITY||Difference in Least Squares Means|3.81|STANDARD_ERROR_OF_MEAN|1.23||0.0024|TWO_SIDED|95.0|1.38|6.24||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline UPSIT, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the UPSIT score at Week 24.||6.24|1.38|0.0024
70990363|NCT03345836|141489067|SUPERIORITY||Adjusted Risk Difference|17.9|||<|0.0001|TWO_SIDED|95.0|10.0|25.8||P-value was calculated using Cochran-Mantel Haenszel (CMH) test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% confidence interval (CI) were calculated using CMH risk difference estimate.|||25.8|10.0|<0.0001
70990364|NCT03345836|141489068|SUPERIORITY||Adjusted Risk Difference|31.2|||<|0.0001|TWO_SIDED|95.0|25.5|37.0||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH risk difference estimate.|||37.0|25.5|<0.0001
70990365|NCT03345836|141489070|SUPERIORITY||Adjusted Treatment Difference|25.9|||<|0.0001|TWO_SIDED|95.0|18.7|33.1||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||33.1|18.7|<0.0001
70990366|NCT03345836|141489071|SUPERIORITY||Adjusted Treatment Difference|16.8|||<|0.0001|TWO_SIDED|95.0|12.0|21.6||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||21.6|12.0|<0.0001
70990367|NCT03345836|141489072|SUPERIORITY||Adjusted Treatment Difference|22.5||||0.0001|TWO_SIDED|95.0|11.1|34.0||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||34.0|11.1|0.0001
70990368|NCT03345836|141489073|SUPERIORITY||Adjusted Treatment Difference|7.5|||<|0.0001|TWO_SIDED|95.0|5.2|9.8||P-value was calculated using mixed effect model repeat measurement (MMRM) with Baseline, treatment, visit, treatment by visit interaction and stratification factors in the model.|MMRM||Point estimate and 95% CI was calculated using MMRM.|||9.8|5.2|< 0.0001
70990369|NCT03345836|141489074|SUPERIORITY||Adjusted Treatment Difference|24.3|||<|0.0001|TWO_SIDED|95.0|17.2|31.5||P-value was calculated using MMRM with Baseline, treatment, visit, treatment by visit interaction and stratification factors in the model.|MMRM||Point estimate and 95% CI was calculated using MMRM.|||31.5|17.2|< 0.0001
70990370|NCT03345836|141489075|SUPERIORITY||Adjusted Treatment Difference|20.7|||<|0.0001|TWO_SIDED|95.0|13.7|27.8||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||27.8|13.7|<0.0001
70990371|NCT03345836|141489076|SUPERIORITY||Adjusted Treatment Difference|22.8|||<|0.0001|TWO_SIDED|95.0|14.4|31.2||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||31.2|14.4|<0.0001
70990372|NCT03345836|141489077|SUPERIORITY||Adjusted Treatment Difference|12.1||||0.0013|TWO_SIDED|95.0|4.7|19.5||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||19.5|4.7|0.0013
70990373|NCT03345836|141489078|SUPERIORITY||Treatment Difference|-2.6||||0.2834|TWO_SIDED|95.0|-7.6|2.4||P-value was calculated using Chi-squared test.|Chi-squared||Point estimate and 95% CI was calculated using Chi-squared test.|||2.4|-7.6|0.2834
70990374|NCT03345836|141489079|SUPERIORITY||Adjusted Treatment Difference|11.5||||0.0833|TWO_SIDED|95.0|-1.5|24.4||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||24.4|-1.5|0.0833
70990375|NCT01555463|141489080|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel|center-adjusted||||||<.001
71039105|NCT03807440|141586010|OTHER|||||||0.3288|||||||Chi-squared|||||||0.3288
71098659|NCT03537729|141705808|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Ratio of mean proportions of errors|0.59||||0.01|TWO_SIDED|95.0|0.39|0.9||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Generalized mixed model analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Ratio of mean proportion of errors for spaced retrieval divided by proportion of errors for control. Log of the mean was estimated from generalized linear mixed effects models for each arm. The difference between logs of means was exponentiated.|The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.||0.90|0.39|.01
70990376|NCT01555463|141489081|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|F-test for treatment effect of the ANCOVA model with treatment group and study center as the factors and baseline lesion count as the covariate.||||||<.001
70990377|NCT01943864|141489098|SUPERIORITY_OR_OTHER||non PD rate at Week 12|10.0||||0.976|TWO_SIDED|95.0|1.2|31.7|||Exact Binomial Test|||||31.7|1.2|0.976
70990378|NCT01943864|141489099|SUPERIORITY_OR_OTHER||non PD rate at Week 12|15.0||||0.909|TWO_SIDED|95.0|3.2|37.9|||Exact Binomial Test|||||37.9|3.2|0.909
70990379|NCT01943864|141489114|SUPERIORITY_OR_OTHER||Median PFS|10.6|||||TWO_SIDED|95.0|4.6|12.1|||||Lower and upper limits and estimation value are in terms of weeks|||12.1|4.6|
70990380|NCT01943864|141489115|SUPERIORITY_OR_OTHER||Median PFS|10.6|||||TWO_SIDED|95.0|4.6|12.7|||||Lower and upper limits and estimation value are in terms of weeks|||12.7|4.6|
70990381|NCT01943864|141489116|SUPERIORITY_OR_OTHER||Overall Survival|20.0|||||TWO_SIDED|95.0|6.2|39.3||||||||39.3|6.2|
70990382|NCT01943864|141489117|SUPERIORITY_OR_OTHER||ORR|0.0|||||TWO_SIDED|95.0|0.0|16.8||||||||16.8|0|
70990383|NCT01943864|141489118|SUPERIORITY_OR_OTHER||ORR|5.0|||||TWO_SIDED|95.0|0.1|24.9||||||||24.9|0.1|
70990384|NCT04370028|141489123|SUPERIORITY||Mean Difference (Net)|4.57|||<|1e-05|TWO_SIDED|95.0|4.42|4.72|||t-test, 2 sided|Paired test was performed||||4.72|4.42|<0.00001
70990385|NCT04370028|141489124|SUPERIORITY||Odds Ratio (OR)|7.2|||<|1e-05|TWO_SIDED|95.0|6.01|8.67|||Fisher Exact||OR estimated (week 1 to week 12) the higher the better|Odds ratio of occuring MoCA score \<26 was assessed||8.67|6.01|<0.00001
70990386|NCT04370028|141489125|SUPERIORITY||Odds Ratio (OR)|5.31|||<|1e-05|TWO_SIDED|95.0|4.28|6.64|||Fisher Exact||OR estimated (week 1 to week 12) the higher the better|Odds ratio of occuring MoCA score \<17 was assessed||6.64|4.28|<0.00001
70990387|NCT04370028|141489126|SUPERIORITY||Mean Difference (Net)|2.375|||<|0.07|TWO_SIDED|95.0|-0.21|4.96|||ANOVA|||Change of mean MoCA score||4.96|-0.21|<0.07
70990388|NCT04370028|141489126|SUPERIORITY||Mean Difference (Net)|4.74|||<|0.01|TWO_SIDED|95.0|4.17|5.31|||ANOVA|||Change of mean MoCA score||5.31|4.17|<0.01
70990389|NCT04370028|141489126|SUPERIORITY||Mean Difference (Net)|4.55|||<|0.01|TWO_SIDED|95.0|4.16|4.94|||ANOVA|||Change of mean MoCA score||4.94|4.16|<0.01
70990390|NCT04370028|141489126|SUPERIORITY||Mean Difference (Net)|4.49|||<|0.01|TWO_SIDED|95.0|3.7|5.27|||ANOVA|||Change of mean MoCA score||5.27|3.7|<0.01
70990391|NCT04370028|141489128|SUPERIORITY||Mean Difference (Net)|0.803|STANDARD_ERROR_OF_MEAN|0.246||0.0011|TWO_SIDED|95.0|0.321|1.28|||ANOVA|||||1.28|0.321|0.0011
70990392|NCT01798706|141489139|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.088|<|0.0001|TWO_SIDED|95.0|-0.81|-0.464||Threshold for significance at 0.05 level.|ANCOVA||Lixisenatide vs Placebo|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 glomerular filtration rate (eGFR) (≥30 to \<60, ≥60 ml/min/1.73 m\^2), and country as fixed effects and baseline HbA1c value as a covariate.||-0.464|-0.81|< 0.0001
71039106|NCT03807440|141586010|OTHER|||||||0.171|||||||Fisher Exact|||||||0.1710
71039107|NCT03807440|141586011|OTHER|||||||0.013|||||||Kruskal-Wallis|||||||0.0130
71039108|NCT03807440|141586012|OTHER|||||||0.0026|||||||Kruskal-Wallis|||||||0.0026
71039109|NCT03807440|141586013|OTHER|||||||0.3978|||||||Kruskal-Wallis|||||||0.3978
71039110|NCT03807440|141586014|OTHER|||||||0.0055|||||||Chi-squared|||||||0.0055
71039111|NCT03807440|141586014|OTHER|||||||0.0041|||||||Fisher Exact|||||||0.0041
71039112|NCT03807440|141586015|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
71039113|NCT03807440|141586016|OTHER|||||||0.0399|||||||Chi-squared|||||||0.0399
71039114|NCT03807440|141586016|OTHER|||||||0.0401|||||||Fisher Exact|||||||0.0401
71039115|NCT03807440|141586034|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
70990393|NCT01798706|141489140|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.05|STANDARD_ERROR_OF_MEAN|0.464|<|0.0001|TWO_SIDED|95.0|-5.96|-4.132||Threshold for significance at 0.05 level. Testing sequence continued only when previous endpoint was statistically significant at 0.05.|ANCOVA||Lixisenatide vs Placebo|Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 eGFR (≥30 to \<60, ≥60 ml/min/1.73 m\^2), and country as fixed effects and baseline 2-hour PPG value as a covariate. Hierarchical testing procedure was used to control type I error at 0.05. Testing was then performed sequentially in the order the endpoints were reported.||-4.132|-5.96|< 0.0001
70990394|NCT01798706|141489141|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.219|<|0.0001|TWO_SIDED|95.0|-1.39|-0.527||Threshold for significance at 0.05 level.|ANCOVA||Lixisenatide vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 eGFR (≥30 to \<60, ≥60 ml/min/1.73 m\^2), and country as fixed effects and baseline 7-point SMPG value as a covariate.||-0.527|-1.39|< 0.0001
70990395|NCT01798706|141489142|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.278|<|0.0001|TWO_SIDED|95.0|-1.862|-0.769||Threshold for significance at 0.05 level.|ANCOVA||Lixisenatide vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 eGFR (≥30 to \<60, ≥60 ml/min/1.73 m\^2), and country as fixed effects and baseline body weight value as a covariate.||-0.769|-1.862|< 0.0001
70990396|NCT01798706|141489143|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.262||0.2347|TWO_SIDED|95.0|-0.828|0.204||Threshold for significance at 0.05 level.|ANCOVA||Lixisenatide vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 eGFR (≥30 to \<60, ≥60 ml/min/1.73 m\^2), and country as fixed effects and baseline FPG value as a covariate.||0.204|-0.828|0.2347
70990397|NCT05896761|141489156|OTHER||Ratio of geometric least square mean|0.926|||||TWO_SIDED|90.0|0.831|1.03||||||||1.03|0.831|
70990398|NCT05896761|141489156|OTHER||Ratio of geometric least square mean|0.929|||||TWO_SIDED|90.0|0.816|1.06||||||||1.06|0.816|
70990399|NCT05896761|141489157|OTHER||Ratio of geometric least square mean|1.06|||||TWO_SIDED|90.0|0.966|1.17||||||||1.17|0.966|
70990400|NCT05896761|141489157|OTHER||Ratio of geometric least square mean|1.18|||||TWO_SIDED|90.0|1.07|1.29||||||||1.29|1.07|
71098660|NCT03537729|141705808|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Ratio of mean proportions of errors|0.9||||0.61|TWO_SIDED|95.0|0.6|1.35||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Generalized mixed model analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Ratio of mean proportion of errors for spaced retrieval divided by proportion of errors for cues. Log of the mean was estimated from generalized linear mixed effects models for each arm. The difference between logs of means was exponentiated.|The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.||1.35|0.60|.61
71098661|NCT03537729|141705808|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Ratio of mean proportions of errors|1.26||||0.26|TWO_SIDED|95.0|0.84|1.88||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Generalized mixed model analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Ratio of mean proportion of errors for cues divided by proportion of errors for control. Log of the mean was estimated from generalized linear mixed effects models for each arm. The difference between logs of means was exponentiated.|The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.||1.88|0.84|.26
71098662|NCT03537729|141705808|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Ratio of mean proportions of errors|0.79||||0.25|TWO_SIDED|95.0|0.53|1.19||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Generalized mixed model analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Ratio of mean proportion of errors for spaced retrieval divided by proportion of errors for control. Log of the mean was estimated from generalized linear mixed effects models for each arm. The difference between logs of means was exponentiated.|The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.||1.19|0.53|.25
71098663|NCT03537729|141705808|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Ratio of mean proportions of errors|0.63||||0.03|TWO_SIDED|95.0|0.42|0.94||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Generalized mixed model analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Ratio of mean proportion of errors for spaced retrieval divided by proportion of errors for cues. Log of the mean was estimated from generalized linear mixed effects models for each arm. The difference between logs of means was exponentiated.|The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.||0.94|0.42|.03
71098664|NCT03537729|141705809|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Mean Difference (Final Values)|-1.71|STANDARD_ERROR_OF_MEAN|1.69||0.31|TWO_SIDED|95.0|-5.03|1.6||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline.|Cues minus control.|The null hypothesis was that means of two arms are equal, the alternative was that means were not equal.||1.60|-5.03|.31
70922873|NCT02412748|141336884|SUPERIORITY|||||||0.962|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.962
70922874|NCT02412748|141336885|SUPERIORITY|||||||0.982|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.982
70922875|NCT02412748|141336886|SUPERIORITY|||||||0.534|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.534
70922876|NCT02412748|141336887|SUPERIORITY|||||||0.73|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.730
70922877|NCT02412748|141336888|SUPERIORITY|||||||0.927|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.927
70922878|NCT02412748|141336889|SUPERIORITY|||||||0.841|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.841
70922879|NCT02412748|141336890|SUPERIORITY|||||||0.722|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.722
70922880|NCT02412748|141336891|SUPERIORITY|||||||0.715|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.715
70922881|NCT02412748|141336892|SUPERIORITY|||||||0.9|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.900
70922882|NCT02412748|141336893|SUPERIORITY|||||||0.271|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.271
70922883|NCT02412748|141336894|SUPERIORITY|||||||0.987|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.987
70922884|NCT02412748|141336895|SUPERIORITY|||||||0.967|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.967
70922885|NCT02412748|141336896|SUPERIORITY|||||||0.693|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.693
70990401|NCT05896761|141489158|OTHER||Ratio of geometric least square mean|1.35|||||TWO_SIDED|90.0|1.22|1.49||||||||1.49|1.22|
70990402|NCT05896761|141489158|OTHER||Ratio of geometric least square mean|1.1|||||TWO_SIDED|90.0|0.975|1.24||||||||1.24|0.975|
70990403|NCT05896761|141489159|OTHER||Ratio of geometric least square mean|1.26|||||TWO_SIDED|90.0|1.12|1.4||||||||1.40|1.12|
70990404|NCT05896761|141489159|OTHER||Ratio of geometric least square mean|1.18|||||TWO_SIDED|90.0|1.09|1.28||||||||1.28|1.09|
70990405|NCT05896761|141489160|OTHER||Ratio of geometric least square mean|1.21|||||TWO_SIDED|90.0|1.13|1.3||||||||1.30|1.13|
70990406|NCT05896761|141489160|OTHER||Ratio of geometric least square mean|1.09|||||TWO_SIDED|90.0|1.0|1.2||||||||1.20|1.00|
70990407|NCT05896761|141489161|OTHER||Ratio of geometric least square mean|1.15|||||TWO_SIDED|90.0|1.07|1.23||||||||1.23|1.07|
70990408|NCT05896761|141489161|OTHER||Ratio of geometric least square mean|1.29|||||TWO_SIDED|90.0|1.2|1.38||||||||1.38|1.20|
70990409|NCT05896761|141489162|OTHER||Ratio of geometric least square mean|1.16|||||TWO_SIDED|90.0|1.08|1.25||||||||1.25|1.08|
70990410|NCT05896761|141489162|OTHER||Ratio of geometric least square mean|0.983|||||TWO_SIDED|90.0|0.89|1.09||||||||1.09|0.890|
70990411|NCT05896761|141489163|OTHER||Ratio of geometric least square mean|1.06|||||TWO_SIDED|90.0|0.991|1.13||||||||1.13|0.991|
70990412|NCT05896761|141489163|OTHER||Ratio of geometric least square mean|1.04|||||TWO_SIDED|90.0|0.974|1.12||||||||1.12|0.974|
70990413|NCT05896761|141489164|OTHER||Ratio of geometric least square mean|1.18|||||TWO_SIDED|90.0|1.11|1.25||||||||1.25|1.11|
70990414|NCT05896761|141489164|OTHER||Ratio of geometric least square mean|1.06|||||TWO_SIDED|90.0|0.989|1.14||||||||1.14|0.989|
70990415|NCT05896761|141489165|OTHER||Ratio of geometric least square mean|1.08|||||TWO_SIDED|90.0|1.03|1.12||||||||1.12|1.03|
70990416|NCT05896761|141489165|OTHER||Ratio of geometric least square mean|1.04|||||TWO_SIDED|90.0|0.997|1.08||||||||1.08|0.997|
71039116|NCT03807440|141586035|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
70990417|NCT05896761|141489166|OTHER||Ratio of geometric least square mean|1.13|||||TWO_SIDED|90.0|1.08|1.19||||||||1.19|1.08|
70990418|NCT05896761|141489166|OTHER||Ratio of geometric least square mean|1.04|||||TWO_SIDED|90.0|0.97|1.11||||||||1.11|0.97|
70990419|NCT05896761|141489167|OTHER||Ratio of geometric least square mean|1.06|||||TWO_SIDED|90.0|1.02|1.11||||||||1.11|1.02|
70990420|NCT05896761|141489167|OTHER||Ratio of geometric least square mean|1.06|||||TWO_SIDED|90.0|1.01|1.11||||||||1.11|1.01|
70990421|NCT03552549|141489197|OTHER||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.28|1.77|||||Hazard ratio presented as PEG-Intron/INTRON A; HR \<1 indicates treatment effect in favor of PEG-Intron.|||1.77|0.28|
70990422|NCT00875017|141489243|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-65.75|||<|0.001||95.0|-96.01|-35.49|||Mixed Models Analysis|||Net phosphorus absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||-35.49|-96.01|<0.001
70990423|NCT00875017|141489243|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-125.65|||<|0.001||95.0|-155.91|-95.39|||Mixed Models Analysis|||Net phosphorus absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||-95.39|-155.91|<0.001
70990424|NCT00875017|141489243|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-59.9|||<|0.001||95.0|-89.87|-29.93|||Mixed Models Analysis|||Net phosphorus absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||-29.93|-89.87|<0.001
70990425|NCT00875017|141489244|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|71.9|||<|0.001||95.0|40.03|103.77|||Mixed Models Analysis|||Phosphorus binding was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||103.77|40.03|<0.001
70990426|NCT00875017|141489245|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.67||||0.049||95.0|-41.22|-0.13|||Mixed Models Analysis|||Net calcium absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||-0.13|-41.22|0.049
70990427|NCT00875017|141489245|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-15.56||||0.133||95.0|-36.11|4.99|||Mixed Models Analysis|||Net calcium absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||4.99|-36.11|0.133
70990428|NCT00875017|141489245|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.11||||0.612||95.0|-15.24|25.47|||Mixed Models Analysis|||Net calcium absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||25.47|-15.24|0.612
70990429|NCT00125658|141489252|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Primary Comparison (i.e., FTP vs. POWER) Data are reported as change scores, between the end of treatment block 1(10 weeks) and baseline; thus, this analysis directly compares FTP vs. Power. A negative value represents improvement (i.e., reduced trunk displacement) while a positive value represents an increase in compensatory trunk movement.||||<.001
70990430|NCT00125658|141489252|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Order effect, testing OrderA (FTP before POWER) vs. OrderB (POWER before FTP). Change scores for trunk displacement at the end of both treatment blocks (20 weeks) relative to baseline (e.g., 20 weeks - baseline) were compared between OrderA and OrderB.||||.002
70990431|NCT00125658|141489253|SUPERIORITY_OR_OTHER|||||||0.13|||||||t-test, 2 sided|||Tests effect of FTP vs. Power. The change in shoulder flexion range of motion was compared between baseline and the end of treatment Block 1 (i.e., 10 weeks).||||0.13
70990432|NCT00125658|141489253|SUPERIORITY_OR_OTHER|||||||0.048|||||||t-test, 2 sided|||Test the effect of treatment order OrderA (FTP before POWER) vs. OrderB (POWER before FTP). The change in shoulder flexion range of motion was compared between the end of treatment (20 weeks) and baseline.||||0.048
70990433|NCT00125658|141489254|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||Compares FTP vs POWER by comparing the change in elbow extension range of motion between the end of treatment block 1 (10 weeks) and baseline.||||.004
70990434|NCT00125658|141489254|SUPERIORITY_OR_OTHER|||||||0.034|||||||t-test, 2 sided|||Tests for the effect of treatment order OrderA (FTP before POWER) vs. OrderB (POWER before FTP) by comparing the change in elbow extension range of motion between the end of overall treatment (20 weeks) and baseline.||||0.034
70990435|NCT00125658|141489255|SUPERIORITY_OR_OTHER|||||||0.056|||||||t-test, 2 sided|||Tests for differences between FTP vs. POWER by comparing the change in movement speed between the end of treatment block 1 (10 weeks) and baseline.||||0.056
70990436|NCT00125658|141489255|SUPERIORITY_OR_OTHER|||||||0.168|||||||t-test, 2 sided|||Tests for effect of treatment order (OrderA (FTP before POWER) vs. OrderB (POWER before FTP))by comparing the change in movement speed between the end of overall treatment (20 weeks) and baseline.||||.168
71039117|NCT03807440|141586036|OTHER|||||||0.0008|||||||Chi-squared|||||||0.0008
71039118|NCT03807440|141586038|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
71039119|NCT03807440|141586039|OTHER|||||||0.0001|||||||Chi-squared|||||||0.0001
71039120|NCT03807440|141586040|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
71039121|NCT03807440|141586041|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
71039122|NCT03807440|141586042|OTHER|||||||0.9184|||||||Chi-squared|||||||0.9184
70990437|NCT00125658|141489256|SUPERIORITY_OR_OTHER|||||||0.564|||||||Wilcoxon (Mann-Whitney)|||Tests the effects of FTP vs. POWER on motor impairment (UE FMA) by comparing the change in FMA between the end of treatment block 1 (10 weeks) and baseline.||||0.564
70990438|NCT00125658|141489256|SUPERIORITY_OR_OTHER|||||||0.948|||||||Wilcoxon (Mann-Whitney)|||Tests for an effect of treatment order (OrderA (FTP before POWER) vs. OrderB (POWER before FTP)) by comparing the change in UE FMA between the end of treatment (20 weeks) and baseline.||||0.948
70990439|NCT00125658|141489257|SUPERIORITY_OR_OTHER|||||||0.078|||||||t-test, 2 sided|||Tests for differences in FTP vs. POWER by comparing the change in RPR between the end of treatment block 1 (10 weeks) and baseline.||||0.078
70990440|NCT00125658|141489257|SUPERIORITY_OR_OTHER|||||||0.4|||||||t-test, 2 sided|||Tests the effect of treatment order (Order A (FTP \> POWER) vs. Order B (POWER \> FTP)) by comparing the change in RPR between the end of overall treatment (20 weeks) and baseline.||||0.4
70990441|NCT00125658|141489258|SUPERIORITY_OR_OTHER|||||||0.085|||||||t-test, 2 sided|||Tests for the effect of treatment (FTP vs. POWER) by comparing the change in movement smoothness between the end of treatment block 1 (10 weeks) and baseline.||||0.085
70990442|NCT00125658|141489258|SUPERIORITY_OR_OTHER|||||||0.635|||||||t-test, 2 sided|||Tests for the effect of treatment order (OrderA (FTP before POWER) vs. OrderB (POWER before FTP)) by comparing the change in movement smoothness between the end of overall treatment (20 weeks) and baseline.||||0.635
70990443|NCT05515601|141489261|OTHER|A linear fixed-effects model is used to estimate the relative bioavailability.|Ratio of Geometric least squares mean|0.986|||||TWO_SIDED|90.0|0.929|1.05||||||||1.05|0.929|
70990444|NCT05515601|141489262|OTHER|A linear fixed-effects model is used to estimate the relative bioavailability.|Ratio of Geometric least squares mean|1.01|||||TWO_SIDED|90.0|0.948|1.08||||||||1.08|0.948|
71039123|NCT03807440|141586042|OTHER|||||||0.9911|||||||Fisher Exact|||||||0.9911
71039124|NCT03807440|141586043|OTHER|||||||0.6967|||||||Chi-squared|||||||0.6967
70990445|NCT05515601|141489263|OTHER|A linear fixed-effects model is used to estimate the relative bioavailability|Ratio of Geometric least squares mean|1.02|||||TWO_SIDED|90.0|0.96|1.09||||||||1.09|0.960|
70990446|NCT00364845|141489265|SUPERIORITY_OR_OTHER||Proportion achieving target|0.389||||||95.0|0.173|0.643||||||||0.643|0.173|
70990447|NCT00364845|141489265|SUPERIORITY_OR_OTHER||Proportion achieving target|0.95||||||95.0|0.751|0.999||||||||0.999|0.751|
71039125|NCT03807440|141586043|OTHER|||||||0.6439|||||||Fisher Exact|||||||0.6439
71039126|NCT03807440|141586044|OTHER|||||||0.9414|||||||Chi-squared|||||||0.9414
70990448|NCT01187901|141489268|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70990449|NCT01187901|141489269|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70990450|NCT01187901|141489270|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70990451|NCT01187901|141489271|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70990452|NCT01187901|141489272|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70990453|NCT01187901|141489273|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70990454|NCT04160468|141489274|SUPERIORITY||Risk Difference (RD)|-10.6||||0.392|TWO_SIDED|95.0|-33.6|12.4|||Fisher Exact|||||12.4|-33.6|0.392
70990455|NCT00088634|141489288|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||Comparisons between SM-13496 and placebo will be performed by means of a 2-way analysis of covariance (ANCOVA) model with treatment group and study center as factors, and baseline BPRS score as a covariate. Ninety-five percent (95%) confidence intervals will be constructed using the variability estimates from the ANCOVA model.||||<0.05
70990456|NCT00088634|141489289|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||Comparisons between SM-13496 and placebo will be performed by means of a 2-way analysis of covariance (ANCOVA) model with treatment group and study center as factors, and baseline PANSS score as a covariate. Ninety-five percent (95%) confidence intervals will be constructed using the variability estimates from the ANCOVA model.||||<0.05
70990457|NCT00088634|141489290|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||Comparisons between SM-13496 and placebo will be performed by means of a 2-way analysis of covariance (ANCOVA) model with treatment group and study center as factors, and baseline CGI-S score as a covariate. Ninety-five percent (95%) confidence intervals will be constructed using the variability estimates from the ANCOVA model.||||<0.05
70990458|NCT00088634|141489291|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||Comparisons between SM-13496 and placebo will be performed by means of a 2-way analysis of covariance (ANCOVA) model with treatment group and study center as factors, and baseline MADRS score as a covariate. Ninety-five percent (95%) confidence intervals will be constructed using the variability estimates from the ANCOVA model.||||<0.05
70990459|NCT00540436|141489292|SUPERIORITY_OR_OTHER||Mean change|33.49||||||95.0|15.231|51.744||||||||51.744|15.231|
70990460|NCT00540436|141489293|SUPERIORITY_OR_OTHER||Mean change|46.82||||||95.0|24.566|69.076||||||||69.076|24.566|
70990461|NCT03255291|141489302|SUPERIORITY|A Dunnett adjustment was used to adjust for multiple comparisons||||||0.0288|||||||ANCOVA|Covariates: sex, race, age, education, health literacy, season, risk display problem, acceptability, self-reported health, and baseline exercise.||The investigators tested whether weekly minutes of exercise at 90 day follow-up was higher in the exercise mental imagery condition than in the sleep mental imagery condition||||0.0288
70990462|NCT03255291|141489302|SUPERIORITY|-A Dunnett adjustment was used to adjust for multiple comparisons||||||0.3329|||||||ANCOVA|Covariates: sex, race, age, education, health literacy, season, risk display problem, acceptability, self-reported health, and baseline exercise.||-The investigators tested whether weekly minutes of exercise differed among the three risk display formats: risk ladder, table, and alphanumeric text.||||0.3329
71039127|NCT03807440|141586044|OTHER|||||||0.8142|||||||Fisher Exact|||||||0.8142
71039128|NCT03807440|141586045|OTHER|||||||0.7837|||||||Chi-squared|||||||0.7837
71039129|NCT03807440|141586045|OTHER|||||||0.7538|||||||Fisher Exact|||||||0.7538
71039130|NCT03807440|141586046|OTHER|||||||0.0012|||||||Chi-squared|||||||0.0012
71039131|NCT03807440|141586047|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
71039132|NCT03807440|141586048|OTHER|||||||0.1906|||||||Chi-squared|||||||0.1906
70990463|NCT03255291|141489302|SUPERIORITY|-A Dunnett adjustment was used to adjust for multiple comparisons||||||0.0215|||||||ANCOVA|Covariates: sex, race, age, education, health literacy, season, risk display problem, acceptability, self-reported health, and baseline exercise.||-The investigators tested whether weekly minutes of exercise was influenced by an interaction between risk display format and mental imagery behavior||||0.0215
70990464|NCT03255291|141489303|SUPERIORITY|||||||0.0333||||||-A Dunnett adjustment was used to adjust for multiple comparisons|ANCOVA|Covariates were sex, race, age, education, numeracy, and graph literacy.||-This study was designed as a 3X2 factorial design and only the risk display format intervention (risk ladder, table, or text) was looked at for this outcome, as participants had not yet received the mental imagery intervention, thus it could not affect this outcome. A Dunnett adjustment was used to adjust for multiple comparisons.||||0.0333
70990465|NCT03255291|141489304|SUPERIORITY|||||||0.4946||||||-A Dunnett adjustment was used to adjust for multiple comparisons|ANCOVA|Covariates were sex, race, age, education, numeracy, and graph literacy.||This study was designed as a 3X2 factorial design \& only the risk display format intervention (risk ladder, table, or text) was looked at for this outcome, as participants had not yet received the mental imagery intervention, thus it could not affect this outcome.||||0.4946
70990466|NCT03255291|141489305|SUPERIORITY|||||||0.1397|||||||ANCOVA|Covariates were sex, race, age, education, numeracy, and graph literacy.||This study was designed as a 3X2 factorial design \& only the risk display format intervention (risk ladder, table, or text) was looked at for this outcome, as participants had not yet received the mental imagery intervention, thus it could not affect this outcome.||||0.1397
70990467|NCT03255291|141489306|SUPERIORITY|||||||0.007||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise maintenance self-efficacy). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichtomous mental imagery variable in this analysis.||||0.0070
70990468|NCT03255291|141489307|SUPERIORITY|||||||0.8793||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise recovery self-efficacy). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichtomous mental imagery variable in this analysis.||||0.8793
70990469|NCT03255291|141489308|SUPERIORITY|||||||0.4673||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise affective attitudes). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.||||0.4673
70990470|NCT03255291|141489309|SUPERIORITY|||||||0.1916||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise unpleasant feelings). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.||||0.1916
71039133|NCT03807440|141586049|OTHER|||||||0.6198|||||||Chi-squared|||||||0.6198
70990471|NCT03255291|141489310|SUPERIORITY|||||||0.8661||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise imagery vividness). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.||||0.8661
70990472|NCT03255291|141489311|SUPERIORITY|||||||0.0711||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise action planning). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.||||0.0711
71039134|NCT03807440|141586049|OTHER|||||||0.7297|||||||Fisher Exact|||||||0.7297
71039135|NCT03807440|141586051|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
71039136|NCT03807440|141586052|OTHER|||||||0.0012|||||||Chi-squared|||||||0.0012
71039137|NCT03807440|141586052|OTHER|||||||0.0002|||||||Fisher Exact|||||||0.0002
71039138|NCT03807440|141586053|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
71039139|NCT03807440|141586056|OTHER|||||||0.003|||||||Log Rank|||||||0.0030
70922886|NCT02412748|141336897|SUPERIORITY|||||||0.557|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.557
70922887|NCT02412748|141336898|SUPERIORITY|||||||0.681|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.681
70922888|NCT02412748|141336899|SUPERIORITY|||||||0.389|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.389
70922889|NCT02412748|141336900|SUPERIORITY|||||||0.846|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.846
70922890|NCT02412748|141336901|SUPERIORITY|||||||0.871|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.871
70922891|NCT02412748|141336902|SUPERIORITY|||||||0.986|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.986
70922892|NCT02412748|141336903|SUPERIORITY|||||||0.791|||||||ANCOVA|||||||.791
70922893|NCT02412748|141336904|SUPERIORITY|||||||0.583|||||||ANCOVA|||||||.583
70922894|NCT02412748|141336905|SUPERIORITY|||||||0.851|||||||ANCOVA|||||||.851
70922895|NCT03069313|141336907|OTHER|Paired t-test|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
70922896|NCT03069313|141336908|OTHER|||||||0.0003|||||||t-test, 2 sided|||||||0.0003
70922897|NCT03069313|141336909|OTHER|This analysis is comparing SWB before and after treatment.||||||0.133|||||||t-test, 2 sided|||||||0.133
70922898|NCT03069313|141336909|OTHER|||||||0.056|||||||t-test, 2 sided|||This analysis is comparing EWB before and after treatment.||||0.056
70922899|NCT03069313|141336909|OTHER||||||<|0.0001|||||||t-test, 2 sided|||This analysis is comparing PWB before and after treatment.||||<0.0001
70922900|NCT03069313|141336909|OTHER|||||||0.09|||||||t-test, 2 sided|||This analysis is comparing FWB before and after treatment.||||0.09
70922901|NCT03069313|141336909|OTHER||||||<|0.0001|||||||t-test, 2 sided|||This analysis is comparing ESS before and after treatment.||||<0.0001
70922902|NCT01872078|141336914|SUPERIORITY_OR_OTHER||Ratio (%)|87.04|||||TWO_SIDED|95.0|58.52|129.47||||||The null hypothesis is that the ratio of Active to Control in LH AUC(0-8) ratio to baseline at day 7= 100%||129.47|58.52|
70990473|NCT03255291|141489312|SUPERIORITY|||||||0.0365||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise coping planning). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.||||0.0365
70922903|NCT01872078|141336914|SUPERIORITY_OR_OTHER||Ratio (%)|78.76|||||TWO_SIDED|95.0|53.41|116.16||||||The null hypothesis is that the ratio of Active to Control in LH AUC(0-8) ratio to baseline at day 7= 100%||116.16|53.41|
70922904|NCT01872078|141336914|SUPERIORITY_OR_OTHER||Ratio (%)|47.99|||||TWO_SIDED|95.0|32.73|70.36||||||The null hypothesis is that the ratio of Active to Control in LH AUC(0-8) ratio to baseline at day 7= 100%||70.36|32.73|
70922905|NCT02721381|141336960|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||The effect of group assignment was examined using MLM, with a significant time X group interaction indicative of an effect of group assignment. Data from T1, T2, and T3 were both used in same analysis.||||<.001
70922906|NCT02721381|141336961|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||The effect of group assignment was examined using MLM, with a significant time X group interaction indicative of an effect of group assignment. Data from T1, T2, and T3 were both used in same analysis.||||<.001
70922907|NCT02721381|141336962|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||The effect of group assignment was examined using MLM, with a significant time X group interaction indicative of an effect of group assignment. Data from T1, T2, and T3 were both used in same analysis.||||.85
70922908|NCT02721381|141336963|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||The effect of group assignment was examined using MLM, with a significant time X group interaction indicative of an effect of group assignment. Data from T1, T2, and T3 were both used in same analysis.||||.85
70922909|NCT02721381|141336964|SUPERIORITY|||||||0.98|||||||ANCOVA|||||||.98
70922910|NCT02721381|141336965|SUPERIORITY|||||||0.69|||||||ANCOVA|||||||.69
70922911|NCT02721381|141336966|SUPERIORITY|||||||0.038|||||||Mixed Models Analysis|||The effect of group assignment was examined using MLM, with a significant time X group interaction indicative of an effect of group assignment. Data from T1, T2, and T3 were both used in same analysis.||||.038
70990474|NCT03255291|141489313|SUPERIORITY|||||||0.1511||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise action self-efficacy). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.||||0.1511
70990475|NCT04019093|141489314|SUPERIORITY|||||||0.99|||||||ANOVA|F(1,46) = .001||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) mixed general linear model on pressure threshold. Here we report the results of the analysis of the beverage condition X group interaction.||||.99
70990476|NCT04019093|141489314|SUPERIORITY||||||<|0.0001|||||||ANOVA|F(1,46)=12.55||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) mixed general linear model on pressure threshold. Here we report the results of the analysis of the main effect of beverage condition.||||<.0001
70990477|NCT04019093|141489314|SUPERIORITY|||||||0.015|||||||ANOVA|F(1,46)=6.32||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) mixed general linear model on pressure threshold. Here we report the results of the analysis of the main effect of group.||||.015
70990478|NCT04019093|141489315|SUPERIORITY|||||||0.76|||||||ANOVA|F(2,82)=.20||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the pressure level X group interaction.||||.76
70990479|NCT04019093|141489315|SUPERIORITY|||||||0.52|||||||ANCOVA|F(2,82)=.66||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the pressure level X beverage condition interaction.||||.52
70990480|NCT04019093|141489315|SUPERIORITY|||||||0.04|||||||ANOVA|F(1,41)=4.53, p=.04||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of beverage condition.||||.04
70990481|NCT04019093|141489315|SUPERIORITY|||||||0.017|||||||ANOVA|F(1,41)=6.24||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of group.||||.017
70990482|NCT04019093|141489315|SUPERIORITY||||||<|0.0001|||||||ANOVA|F(2,82)=48.41||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of pressure level.||||<.0001
70990483|NCT04019093|141489316|SUPERIORITY|||||||0.5|||||||ANOVA|F (2, 82) = 0.69||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the beverage condition X pressure level X group interaction.||||.50
70990484|NCT04019093|141489316|SUPERIORITY|||||||0.21|||||||ANOVA|F(2,82)=1.58||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the beverage condition X pressure level interaction.||||.21
70990485|NCT04019093|141489316|SUPERIORITY|||||||0.053|||||||ANOVA|F(2,82)=3.06||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the pressure level X group interaction.||||.053
70990486|NCT04019093|141489316|SUPERIORITY|||||||0.98|||||||ANOVA|F(1,41)=.001||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the beverage condition X group interaction.||||.98
70990487|NCT04019093|141489316|SUPERIORITY|||||||0.71|||||||ANOVA|F(2,82)=.34||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of pressure level.||||.71
70990488|NCT04019093|141489316|SUPERIORITY|||||||0.71|||||||ANOVA|F(1,41)=.14||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of group.||||.71
70990489|NCT04019093|141489316|SUPERIORITY||||||<|0.0001|||||||ANOVA|F(1,41)=55.02||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of beverage condition.||||<.0001
70990490|NCT00962039|141489318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.01||||0.92|TWO_SIDED|95.0|-0.12|0.1||Analyses were conducted over 8 week follow-up.|Chi-squared|||||0.10|-0.12|0.92
70990491|NCT00962039|141489319|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.08||||0.034|TWO_SIDED|95.0|-0.15|-0.01|||Chi-squared|||||-0.01|-0.15|0.034
70990492|NCT00962039|141489320|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.03||||0.261|TWO_SIDED|95.0|-0.07|0.02|||t-test, 2 sided|||||0.02|-0.07|0.261
70990493|NCT00962039|141489321|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.09||||0.519|TWO_SIDED|95.0|-0.36|0.18|||t-test, 2 sided|||||0.18|-0.36|0.519
70990494|NCT00962039|141489322|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.12||||0.704|TWO_SIDED|95.0|-0.77|0.52|||t-test, 2 sided|||||0.52|-0.77|0.704
70990495|NCT00962039|141489323|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.59||||0.046|TWO_SIDED|95.0|0.01|1.17|||t-test, 2 sided|||||1.17|0.01|0.046
70990496|NCT01067508|141489324|OTHER|||||||0.003||||||p\<0.05 was defined as significant|t-test, 2 sided|||Comparison was made to 12 weeks minus baseline change in Fiji water group||||0.003
70990497|NCT01067508|141489324|OTHER|||||||0.68||||||p\<0.05 was defined as significant|t-test, 2 sided|||Comparison was made to the 12 week minus baseline change in Aquafina (control) group||||0.68
70922912|NCT02721381|141336967|SUPERIORITY|||||||0.45|||||||Mixed Models Analysis|||The effect of group assignment was examined using MLM, with a significant time X group interaction indicative of an effect of group assignment. Data from T1, T2, and T3 were both used in same analysis.||||.45
70922913|NCT02721381|141336968|SUPERIORITY|||||||0.92|||||||ANCOVA|||ANCOVA controlling for T1 measure||||.92
70922914|NCT02721381|141336969|SUPERIORITY|||||||0.42|||||||ANCOVA|||ANCOVA controlling for T1 measure||||.42
70990498|NCT00091390|141489338|SUPERIORITY_OR_OTHER_LEGACY||hazard rate|0.0014|||<|0.0001|TWO_SIDED|95.0|0.0|0.003|||Z-test|One-sided.||The study is designed to test whether the 18-month late GU/GI toxicity following the protocol treatment is above 10% (hazard rate of 0.012/month). The sample size is determined so that the probability of rejecting the treatment because of excessive late toxicity is 90% if the true late toxicity rate is 20% (hazard rate of 0.025/month). Ninety-eight patients are required to with an additional 18 months of follow-up to have a statistical power of 90% with one-sided significance level of 0.05.||0.003|0|<0.0001
70990499|NCT03229759|141489346|SUPERIORITY||Mean Difference (Final Values)|1.48|||||TWO_SIDED|95.0|0.88|2.08||||||Test on abdomen Average treatment effect was calculated using a linear regression model for each body site was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.08|0.88|
70922915|NCT02721381|141336970|SUPERIORITY|||||||0.65|||||||ANCOVA|||ANCOVA controlling for T1 measure||||.65
70922916|NCT02721381|141336971|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Independent samples t-test||||.001
70922917|NCT04337372|141336972|SUPERIORITY||||||=|0.002||||||F(2, 58) = 7.19|MANOVA|||To examine the impact of infant age and label condition on the proportion of infant's attention to the book, a 3 (infant age: 6, 9, or 12 months) x 3 (label condition: individual, categorical, or no label) MANOVA was run. Age was measured between subjects, label condition was within subjects, and infant's proportion of attention to the book was the dependent variable. The main effect of age is reported here.||||=.002
70922918|NCT04337372|141336972|SUPERIORITY||||||=|0.09||||||F(1.78, 103.37) = 2.48|MANOVA|||To examine the impact of infant age and label condition on the proportion of infant's attention to the book, a 3 (infant age: 6, 9, or 12 months) x 3 (label condition: individual, categorical, or no label) MANOVA was run. Age was measured between subjects, label condition was within subjects, and infant's proportion of attention to the book was the dependent variable. The main effect of condition is reported here.||||=.09
71039140|NCT00323258|141586057|NON_INFERIORITY_OR_EQUIVALENCE|"Equivalence analysis. Null hypothesis: The will be no difference in proportion of participants adherent to triple therapy in the treatment arm compared to those who receive usual care."||||||0.5|||||||Chi-squared|||Sample size of 286 patients(143 patients per group).Based on an estimated absolute improvement in medication adherence of 15% in the intervention group (eg, 85% in the intervention group, 70% in the control group), a 2-sided test with α level of .05, a 15% dropout rate, and power of 0.80.||||.50
71039141|NCT00323258|141586058|NON_INFERIORITY_OR_EQUIVALENCE|"Equivalence analysis. Null hypothesis: The will be no difference in the proportion of participants who are \>/= 75% adherent to combined beta-blocker and statin therapy in the treatment arm compared to those who receive usual care."|||||=|0.11|||||||Chi-squared|||Sample Size calculated as 286 total or 143 patient per treatment group. Based on a baseline adherence rate of 70%, an estimated absolute improvement in medication adherence of 15.0% in the intervention group, we would require 122 patients per group assuming a 2-sided test with alpha-level of .05 and power of .80. To sustain a 15% dropout/ loss to follow-up rate, about 143 patients per group (286 patients total) would need to be consented.||||=0.11
71039142|NCT00323258|141586059|NON_INFERIORITY_OR_EQUIVALENCE|"Equivalence analysis. Null hypothesis: The will be no difference in the proportion of participants who are \>/= 75% adherent to beta-blockers in the treatment arm compared to those who receive usual care."||||||0.03|||||||Chi-squared|||Sample Size calculated as 286 total or 143 patient per treatment group. Based on a baseline adherence rate of 70%, an estimated absolute improvement in medication adherence of 15.0% in the intervention group, we would require 122 patients per group assuming a 2-sided test with alpha-level of .05 and power of .80. To sustain a 15% dropout/ loss to follow-up rate, about 143 patients per group (286 patients total) would need to be consented.||||0.03
71039143|NCT00323258|141586060|NON_INFERIORITY_OR_EQUIVALENCE|"Equivalence analysis. Null hypothesis: The will be no difference in the proportion of participants who are \>/= 75% adherent to statins in the treatment arm compared to those who receive usual care."||||||0.34|||||||Chi-squared|||Sample Size calculated as 286 total or 143 patient per treatment group. Based on a baseline adherence rate of 70%, an estimated absolute improvement in medication adherence of 15.0% in the intervention group, we would require 122 patients per group assuming a 2-sided test with alpha-level of .05 and power of .80. To sustain a 15% dropout/ loss to follow-up rate, about 143 patients per group (286 patients total) would need to be consented.||||0.34
70990500|NCT03229759|141489346|SUPERIORITY||Mean Difference (Final Values)|1.34|||||TWO_SIDED|95.0|0.72|1.96||||||Tested on the abdomen Analysis was performed based on deferral letters from the FDA. Average treatment effect was calculated using a linear regression model for each body site was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||1.96|0.72|
70990501|NCT03229759|141489346|SUPERIORITY||Mean Difference (Final Values)|1.93|||||TWO_SIDED|95.0|1.38|2.47||||||Groin||2.47|1.38|
70990502|NCT03229759|141489346|SUPERIORITY||Mean Difference (Final Values)|1.26|||||TWO_SIDED|95.0|0.73|1.79||||||Groin||1.79|0.73|
70990503|NCT00833248|141489349|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be established if the treatment difference in adjusted (for baseline volume, and baseline total IPSS) mean percentage reduction was significantly greater (two-sided at α=0.05 level) than Δ = 10 points (non-inferiority margin) in both the FAS and PP analyses sets.|Mean Difference (Final Values)|-0.3||||0.8942|TWO_SIDED|95.0|-4.74|4.14|||ANCOVA|The baseline IPSS and baseline Prostate volume were used as covariates and treatment was used as a factor in the analysis.||FAS. Estimates from analysis of variance with treatment as factors and baseline IPSS and baseline Prostate volume as covariates.||4.14|-4.74|0.8942
70990504|NCT00833248|141489350|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be established if the treatment difference in adjusted (for baseline volume, and baseline total IPSS) mean percentage reduction was significantly greater (two-sided at α=0.05 level) than Δ = 10 points (non-inferiority margin) in both the FAS and PP analyses sets.|Mean Difference (Final Values)|-0.268||||0.9123|TWO_SIDED|95.0|-5.05|4.52|||ANCOVA|The baseline IPSS and baseline Prostate volume were used as covariates and treatment was used as a factor in the analysis.||PP analysis set. Estimates from analysis of variance with treatment as factors and baseline IPSS and baseline Prostate volume as covariates.||4.52|-5.05|0.9123
70990505|NCT00401622|141489403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.56|STANDARD_ERROR_OF_MEAN|7.51||0.31|TWO_SIDED|95.0|-7.24|22.36|||t-test, 2 sided|||||22.36|-7.24|0.31
70990506|NCT00401622|141489404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.11||0.45|TWO_SIDED|95.0|-0.38|0.04|||ANCOVA|Visit 1 A1c measurement used as the covariate||Change in A1C from baseline to week 52 between the OneTouch® Ultra®2 and control BGMS||0.04|-0.38|0.45
70990507|NCT00520676|141489409|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||<|0.001|TWO_SIDED|95.0|0.34|0.6||The comparison was conducted at a 1-sided significance level of 0.05.|Log Rank|Note that the 2-sided p-value for log rank is reported, which is \<0.001, hence 1-sided p-value is \<0.001.|Cox regression model is used for HR estimate.|||0.60|0.34|<0.001
70990508|NCT00520676|141489410|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.934|TWO_SIDED|95.0|0.72|1.42||The comparison was conducted at a 2-sided significance level of 0.05.|Log Rank||Cox regression model is used for hazard ratio (HR) estimate.|||1.42|0.72|0.934
70990509|NCT00520676|141489411|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.8|TWO_SIDED|95.0|0.72|1.29||The comparison was conducted at a 2-sided significance level of 0.05.|Log Rank|Cox regression model is used for hazard ratio (HR) estimate.||||1.29|0.72|0.800
70990510|NCT00520676|141489412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.081|TWO_SIDED|95.0|0.93|3.15||The comparison of tumor response rates was conducted at a 2-sided significance level of 0.05.|Fisher Exact|Tumor response rate= # participants with a confirmed best response of CR or PR / # of participants who qualify for the analysis population.|Logistic regression model is used for odds ratio (OR) estimate.|||3.15|0.93|0.081
70922919|NCT04337372|141336972|SUPERIORITY||||||<|0.05||||||F(3.56, 103.37) = 2.55|MANOVA|||To examine the impact of infant age and label condition on the proportion of infant's attention to the book, a 3 (infant age: 6, 9, or 12 months) x 3 (label condition: individual, categorical, or no label) MANOVA was run. Age was measured between subjects, label condition was within subjects, and infant's proportion of attention to the book was the dependent variable. The interaction between age and condition is reported here.||||<.05
70922920|NCT04337372|141336973|SUPERIORITY||||||=|0.557||||||F(2,47) = .592|MANOVA|||EEG power, as measured by the signal-to-noise ratio (SNR) was modulated by label condition across age, data were extracted from a mid-occipital cluster of Oz and its 6 nearest neighbors (channels 70, 71, 74, 75, 76, 82, 83) for each of the conditions. SNR data were then submitted to a two-factor MANOVA with Label (Individual, Category, Control/No Label) as a within-subjects factor and Age (6 months, 9 months, 12 months) as a between-subjects factor. The main effect of age is reported here.||||=.557
70922921|NCT04337372|141336973|SUPERIORITY||||||=|0.47||||||F(2,47) = .767|MANOVA|||EEG power, as measured by the signal-to-noise ratio (SNR) was modulated by label condition across age, data were extracted from a mid-occipital cluster of Oz and its 6 nearest neighbors (channels 70, 71, 74, 75, 76, 82, 83) for each of the conditions. SNR data were then submitted to a two-factor MANOVA with Label (Individual, Category, Control/No Label) as a within-subjects factor and Age (6 months, 9 months, 12 months) as a between-subjects factor. The main effect of condition is reported here.||||=.470
71098665|NCT03537729|141705809|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|1.75||0.66|TWO_SIDED|95.0|-4.23|2.66||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline.|Spaced retrieval minus control.|The null hypothesis was that means of two arms are equal, the alternative was that means were not equal.||2.66|-4.23|.66
70922922|NCT04337372|141336973|SUPERIORITY||||||=|0.046||||||F(4,94) = 2.524|MANOVA|||EEG power, as measured by signal-to-noise ratio (SNR) was modulated by label condition across age, data were extracted from a mid-occipital cluster of Oz and its 6 nearest neighbors (channels 70, 71, 74, 75, 76, 82, 83) for each condition. SNR data were then submitted to a two-factor MANOVA with Label (Individual, Category, Control/No Label) as a within-subjects factor and Age (6 months, 9 months, 12 months) as a between-subjects factor. The interaction of age and condition is reported here.||||=.046
70922923|NCT04337372|141336974|SUPERIORITY||||||=|0.664||||||F(2,45) = .413|MANOVA|||EEG Data were extracted from a mid-occipital cluster for each conditions for parents \& infants. Data were entered into a 2-factor MANOVA with Label (Individual, Category, No Label) as a within-subjects factor and Age (6 mo, 9 mo, 12 mo) as a between-subjects factor. The phase-locking index measures the extent to which the parent \& infant oscillatory response is in the same phase across time (bounded between 0 and 1, 1 being perfect synchrony. The main effect of age is reported here.||||=.664
70922924|NCT04337372|141336974|SUPERIORITY||||||=|0.768||||||F(2,45) = .266|MANOVA|||EEG Data were extracted from a mid-occipital cluster for each conditions for parents \& infants. Data were entered into a 2-factor MANOVA with Label (Individual, Category, No Label) as a within-subjects factor and Age (6 mo, 9 mo, 12 mo) as a between-subjects factor. The phase-locking index measures the extent to which the parent \& infant oscillatory response is in the same phase across time (bounded between 0 and 1, 1 being perfect synchrony. The main effect of condition is reported here.||||=.768
70922925|NCT04337372|141336974|SUPERIORITY||||||=|0.2||||||F(4,90) = 1.531|MANOVA|||EEG Data were extracted from a mid-occipital cluster for each conditions for parents \& infants. Data were entered into a 2-factor MANOVA with Label (Individual, Category, No Label) as a within-subjects factor and Age (6 mo, 9 mo, 12 mo) as a between-subjects factor. The phase-locking index measures the extent to which the parent \& infant oscillatory response is in the same phase across time (bounded between 0 and 1, 1 being perfect synchrony. The interaction of age and condition is reported.||||=.200
70922926|NCT04337372|141336975|SUPERIORITY||||||=|0.022||||||F(2, 57) = 4.11|MANOVA|||To examine the impact of infant age and label condition on the proportion of joint attention to the book, a 3 (infant age: 6, 9, or 12 months) x 3 (label condition: individual, categorical, or no label) MANOVA was run. Age was measured between subjects, label condition was within subjects, and the proportion of joint attention to the book was the dependent variable. The main effect of age is reported here.||||=.022
70922927|NCT04337372|141336975|SUPERIORITY||||||=|0.004||||||F(2, 114) = 5.69|MANOVA|||To examine the impact of infant age and label condition on the proportion of joint attention to the book, a 3 (infant age: 6, 9, or 12 months) x 3 (label condition: individual, categorical, or no label) MANOVA was run. Age was measured between subjects, label condition was within subjects, and the proportion of joint attention to the book was the dependent variable. The main effect of condition is reported here.||||=.004
70922928|NCT04337372|141336975|SUPERIORITY||||||=|0.168||||||F(4, 114) = 1.64|MANOVA|||To examine the impact of infant age and label condition on the proportion of joint attention to the book, a 3 (infant age: 6, 9, or 12 months) x 3 (label condition: individual, categorical, or no label) MANOVA was run. Age was measured between subjects, label condition was within subjects, and the proportion of joint attention to the book was the dependent variable. The interaction of age and condition is reported here.||||=.168
70922929|NCT05687903|141336992|SUPERIORITY||Estimate of LS Mean Difference|13.65|STANDARD_ERROR_OF_MEAN|2.983|=|0.001|TWO_SIDED|95.0|7.74|19.57||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.|LS in LS Mean Difference denotes least squares.|||19.57|7.74|=0.001
70922930|NCT05687903|141336992|SUPERIORITY||Estimate of LS Mean Difference|24.67|STANDARD_ERROR_OF_MEAN|2.921|<|0.001|TWO_SIDED|95.0|18.87|30.46||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||30.46|18.87|<0.001
70990511|NCT00520676|141489413|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.641|TWO_SIDED|95.0|0.49|1.55||The comparison was conducted at a 2-sided significance level of 0.05.|Log Rank||Cox regression model is used for hazard ratio (HR) estimate.|||1.55|0.49|0.641
71098666|NCT03537729|141705809|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|1.65||0.57|TWO_SIDED|95.0|-2.3|4.17||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline.|Spaced retrieval minus cues only.|The null hypothesis was that means of two arms are equal, the alternative was that means were not equal.||4.17|-2.30|.57
71098667|NCT01654250|141705823|SUPERIORITY_OR_OTHER||Least Square(LS) Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.99|<|0.001|TWO_SIDED|95.0|-10.9|-3.1|||Mixed Models Analysis|||Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point, and time point by treatment interaction as main effects and participant intercept as a random effect.||-3.1|-10.9|<0.001
71098668|NCT01654250|141705824|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.2|STANDARD_ERROR_OF_MEAN|2.28|<|0.001|TWO_SIDED|95.0|-12.7|-3.7|||Mixed Models Analysis|||Hour 0.75 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-3.7|-12.7|<0.001
71098669|NCT01654250|141705824|SUPERIORITY_OR_OTHER|||||||0.133|||||||Mixed Models Analysis|||Hour 0.75 post-dose: Adjusted p-values were generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.||||0.133
71098670|NCT01654250|141705824|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.8|STANDARD_ERROR_OF_MEAN|2.28|<|0.001|TWO_SIDED|95.0|-17.3|-8.3|||Mixed Models Analysis|||Hour 2 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-8.3|-17.3|<0.001
71098671|NCT01654250|141705824|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Hour 2 post-dose: Adjusted p-values were generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.||||<0.001
71098672|NCT01654250|141705824|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.3|STANDARD_ERROR_OF_MEAN|2.28|<|0.001|TWO_SIDED|95.0|-16.8|-7.8|||Mixed Models Analysis|||Hour 4 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-7.8|-16.8|<0.001
71098673|NCT01654250|141705824|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Hour 4 post-dose: Adjusted p-values were generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.||||<0.001
71098674|NCT01654250|141705824|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|2.28|<|0.001|TWO_SIDED|95.0|-12.3|-3.3|||Mixed Models Analysis|||Hour 8 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effect and participant intercept as a random effect.||-3.3|-12.3|<0.001
71098675|NCT01654250|141705824|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Hour 8 post-dose: Adjusted p-values were generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.||||<0.001
71098676|NCT01654250|141705824|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|2.28||0.133|TWO_SIDED|95.0|-7.9|1.1|||Mixed Models Analysis|||Hour 10 post-dose: Nominal p-value -treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||1.1|-7.9|0.133
70990512|NCT00520676|141489414|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53|||<|0.001|TWO_SIDED|95.0|0.4|0.71||The comparison was conducted at a 2-sided significance level of 0.05.|Log Rank||Cox regression model is used for unadjusted hazard ratio (HR) estimate.|||0.71|0.40|<0.001
70990513|NCT00520676|141489415|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.35|0.66||The comparison was conducted at a 2-sided significance level of 0.05.|Log Rank||Cox regression model is used for unadjusted hazard ratio (HR) estimate.|||0.66|0.35|<0.001
71098677|NCT01654250|141705824|SUPERIORITY_OR_OTHER|||||||0.133|||||||Mixed Models Analysis|||Hour 10 post-dose: Adjusted p-value were generated using a fixed sequence testing procedure from p-values generated from the mixed effects model.||||0.133
71098678|NCT01654250|141705824|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|2.28||0.206|TWO_SIDED|95.0|-7.4|1.6|||Mixed Models Analysis|||Hour 12 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||1.6|-7.4|0.206
71098679|NCT01654250|141705824|SUPERIORITY_OR_OTHER|||||||0.133|||||||Mixed Models Analysis|||Hour 12 post-dose: Adjusted p-values are generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.||||0.133
70990514|NCT03439748|141489429|SUPERIORITY|||||||0.002||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference between PAT and NAT as small as d=.35.||||.002
70990515|NCT03439748|141489430|SUPERIORITY||||||>|0.05||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference between PAT and NAT as small as d=.35.||||>.05
70990516|NCT03439748|141489431|SUPERIORITY|||||||0.024||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference between PAT and NAT as small as d=.35.||||.024
70990517|NCT03439748|141489435|SUPERIORITY|||||||0.922||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.922
70990518|NCT03439748|141489436|SUPERIORITY|||||||0.049||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.049
70990519|NCT03439748|141489437|SUPERIORITY|||||||0.591||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.591
70990520|NCT03439748|141489438|SUPERIORITY|||||||0.004||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.004
70990521|NCT03439748|141489439|SUPERIORITY|||||||0.03||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.030
70990522|NCT03439748|141489440|SUPERIORITY|||||||0.029||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.029
70922931|NCT05687903|141336992|SUPERIORITY||Estimate of LS Mean Difference|26.58|STANDARD_ERROR_OF_MEAN|2.91|<|0.001|TWO_SIDED|95.0|20.81|32.35||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||32.35|20.81|<0.001
70990523|NCT03439748|141489442|SUPERIORITY|||||||0.494||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.494
70990524|NCT03439748|141489443|SUPERIORITY|||||||0.231||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.231
70990525|NCT03439748|141489444|SUPERIORITY|||||||0.344||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.344
70990526|NCT03439748|141489445|SUPERIORITY|||||||0.267||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.267
70990527|NCT03439748|141489446|SUPERIORITY|||||||0.051||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.051
70990528|NCT00782418|141489449|SUPERIORITY_OR_OTHER||Least Squares Mean|1.6|||<|0.001||90.0|1.29|1.92||1-sided, alpha=0.05|ANOVA|||||1.92|1.29|<0.001
70990529|NCT00782418|141489449|SUPERIORITY_OR_OTHER||Least Squares Mean|0.95|||<|0.001||90.0|0.66|1.24|||ANOVA|1-sided, alpha=0.05||||1.24|0.66|<0.001
70990530|NCT00782418|141489449|SUPERIORITY_OR_OTHER||Least Squares Mean|2.32|||<|0.001||90.0|1.57|3.06|||ANOVA|1-sided, alpha=0.05||||3.06|1.57|<0.001
70990531|NCT00782418|141489449|SUPERIORITY_OR_OTHER||Least Squares Mean|1.38|||<|0.001||90.0|0.64|2.12|||ANOVA|1-sided, alpha = 0.05||||2.12|0.64|<0.001
70990532|NCT00782418|141489450|SUPERIORITY_OR_OTHER||Least Squares Mean|23.1|||<|0.001||90.0|19.2|27.0|||ANOVA|1-side, alpha = 0.05||||27.0|19.2|<0.001
70922932|NCT05687903|141336992|SUPERIORITY||Estimate of LS Mean Difference|16.13|STANDARD_ERROR_OF_MEAN|2.842|<|0.001|TWO_SIDED|95.0|10.49|21.76||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||21.76|10.49|<0.001
70922933|NCT05687903|141336993|SUPERIORITY||Estimate of LS Mean Difference|-6.42|STANDARD_ERROR_OF_MEAN|1.564|=|0.004|TWO_SIDED|95.0|-9.53|-3.32||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||-3.32|-9.53|=0.004
70922934|NCT05687903|141336993|SUPERIORITY||Estimate of LS Mean Difference|-11.3|STANDARD_ERROR_OF_MEAN|1.581|<|0.001|TWO_SIDED|95.0|-14.44|-8.16||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||-8.16|-14.44|<0.001
70922935|NCT05687903|141336993|SUPERIORITY||Estimate of LS Mean Difference|-10.31|STANDARD_ERROR_OF_MEAN|1.53|<|0.001|TWO_SIDED|95.0|-13.35|-7.27||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||-7.27|-13.35|<0.001
70922936|NCT05687903|141336993|SUPERIORITY||Estimate of LS Mean Difference|-8.79|STANDARD_ERROR_OF_MEAN|1.535|<|0.001|TWO_SIDED|95.0|-11.84|-5.75||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||-5.75|-11.84|<0.001
70922937|NCT05687903|141336994|SUPERIORITY||IRR|0.48|||=|0.25|TWO_SIDED|95.0|0.25|0.93||GEE model featuring a negative binomial distribution was used for analysis where incidence rate was exponentiated LS mean \& incidence rate ratio (IRR) was exponentiated LS mean difference from placebo. Reported p-value is adjusted for multiplicity.|GEE|||The GEE model was used for analysis with fixed effects for visit, treatment, treatment-by-visit interaction, Baseline WCR, age, and prior use of narcolepsy medications.||0.93|0.25|=0.250
70922938|NCT05687903|141336994|SUPERIORITY||IRR|0.36|||=|0.034|TWO_SIDED|95.0|0.16|0.79||The GEE model featuring a negative binomial distribution was used for analysis where the incidence rate was the exponentiated LS mean and the IRR was the exponentiated LS mean difference from placebo. Reported p-value is adjusted for multiplicity.|GEE|||The GEE model was used for analysis with fixed effects for visit, treatment, treatment-by-visit interaction, Baseline WCR, age, and prior use of narcolepsy medications.||0.79|0.16|=0.034
70922939|NCT05687903|141336994|SUPERIORITY||IRR|0.28|||=|0.003|TWO_SIDED|95.0|0.13|0.6||The GEE model featuring a negative binomial distribution was used for analysis where the incidence rate was the exponentiated LS mean and the IRR was the exponentiated LS mean difference from placebo. Reported p-value is adjusted for multiplicity.|GEE|||The GEE model was used for analysis with fixed effects for visit, treatment, treatment-by-visit interaction, Baseline WCR, age, and prior use of narcolepsy medications.||0.60|0.13|=0.003
70922940|NCT05687903|141336994|SUPERIORITY||IRR|0.67|||=|0.25|TWO_SIDED|95.0|0.35|1.29||The GEE model featuring a negative binomial distribution was used for analysis where the incidence rate was the exponentiated LS mean and the IRR was the exponentiated LS mean difference from placebo. Reported p-value is adjusted for multiplicity.|GEE|||The GEE model was used for analysis with fixed effects for visit, treatment, treatment-by-visit interaction, Baseline WCR, age, and prior use of narcolepsy medications.||1.29|0.35|=0.250
70922941|NCT04869982|141337044|OTHER|VE was defined as 1 minus the relative risk (RR). RR was defined as the ratio of the incidence rates of the RZV Group over the Placebo Group. The VE of RZV against HZ was to be demonstrated if the lower limit (LL) of the two-sided 95% CI of VE was above 25%.|VE (1-RR)|100.0|||<|0.0001|TWO_SIDED|95.0|89.82|100.0||All p-values reported were related to the null hypothesis test VE = 0.|Poisson|The CI for VE is derived from the exact CI from RR.||To demonstrate the vaccine efficacy (VE) of RZV against HZ, the analysis considered the exact inference on the relative risk adjusted for age strata conditionally to the total number of confirmed HZ cases observed and time at risk. This method computed an exact confidence interval (CI) around the rate ratio (ratio of the event rates in the RZV Group versus Placebo Group) and accounted for the sum of the time at risk of the participants within each group.||100|89.82|<0.0001
70922942|NCT03857620|141337066|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.53|TWO_SIDED|95.0|-0.85|0.45|||Mixed Models Analysis|Generalized linear mixed effects model (w/ Gaussian link) w/ random practice effect to account for clustering by site \& bsl CHAMPS score as covariate||Combined Arm II (OPTI-Surg) \& Arm III (OPTI-Surg plus Coach) vs. Arm I (Usual Care)||0.45|-0.85|0.53
70990533|NCT00782418|141489450|SUPERIORITY_OR_OTHER||Least Squares Mean|16.4|||<|0.001||90.0|12.6|20.1|||ANOVA|1-side, alpha = 0.05||||20.1|12.6|<0.001
70990534|NCT00782418|141489451|SUPERIORITY_OR_OTHER||Least Squares Mean|545.0|||<|0.001||90.0|451.4|638.7|||ANOVA|1-side, alpha = 0.05||||638.7|451.4|<0.001
70922943|NCT03857620|141337066|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.84|TWO_SIDED|95.0|-0.67|0.81|||Mixed Models Analysis|Generalized linear mixed effects model (w/ Gaussian link) w/ random practice effect to account for clustering by site \& bsl CHAMPS score as covariate||||0.81|-0.67|0.84
70990535|NCT00782418|141489451|SUPERIORITY_OR_OTHER||Least Squares Mean|246.6|||<|0.001||90.0|160.9|323.3|||ANOVA|1-side, alpha = 0.05||||323.3|160.9|<0.001
70990536|NCT01718509|141489452|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-1.66|||<|0.001|TWO_SIDED|95.0|-2.04|-1.28|||Mixed Models Repeated Measures Analysis|||||-1.28|-2.04|<0.001
70990537|NCT01718509|141489453|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||||||<0.001
70990538|NCT01718509|141489454|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||||||<0.001
70990539|NCT01718509|141489455|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-5.41|||<|0.001|TWO_SIDED|95.0|-6.39|-4.44|||Mixed Models Repeated Measures Analysis|||||-4.44|-6.39|<0.001
70990540|NCT01718509|141489456|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-7.94|||<|0.001|TWO_SIDED|95.0|-9.51|-6.36|||Mixed Models Repeated Measures Analysis|||||-6.36|-9.51|<0.001
70990541|NCT01718509|141489457|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.196||||0.002|TWO_SIDED|95.0|-0.321|-0.07|||ANCOVA|||||-0.070|-0.321|0.002
70990542|NCT01718509|141489458|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.077||||0.234|TWO_SIDED|95.0|-0.205|0.05|||ANCOVA|||||0.050|-0.205|0.234
70990543|NCT01718509|141489459|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.03||||0.185|TWO_SIDED|95.0|-0.02|0.08|||ANCOVA|||||0.08|-0.02|0.185
70990544|NCT01718509|141489460|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Cochran-Mantel-Haenszel|||||||<0.001
70990545|NCT01718509|141489461|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.23|||<|0.001|TWO_SIDED|95.0|-2.77|-1.69||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||||-1.69|-2.77|<0.001
70922944|NCT03857620|141337066|SUPERIORITY||Mean Difference (Final Values)|-0.48||||0.19|TWO_SIDED|95.0|-1.21|0.26|||Mixed Models Analysis|Generalized linear mixed effects model (w/ Gaussian link) w/ random practice effect to account for clustering by site \& bsl CHAMPS score as covariate||||0.26|-1.21|0.19
70922945|NCT03857620|141337066|SUPERIORITY||Mean Difference (Final Values)|0.55||||0.14|TWO_SIDED|95.0|-0.19|1.29|||Mixed Models Analysis|Generalized linear mixed effects model (w/ Gaussian link) w/ random practice effect to account for clustering by site \& bsl CHAMPS score as covariate||||1.29|-0.19|0.14
70922946|NCT03857620|141337067|SUPERIORITY||Odds Ratio (OR)|0.7||||0.5|TWO_SIDED|95.0|0.23|2.09|||Mixed Models Analysis|Generalized linear mixed effects model (with logit link function) with a random practice effect to account for clustering within practice||Combined Arm II (OPTI-Surg) \& Arm III (OPTI-Surg plus Coach) vs. Arm I (Usual Care)||2.09|0.23|0.50
70990546|NCT01718509|141489462|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.27||||0.011|TWO_SIDED|95.0|0.29|2.24||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Cognitive Restraint of Eating||2.24|0.29|0.011
70990547|NCT01718509|141489462|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-3.6|||<|0.001|TWO_SIDED|95.0|-4.44|-2.76||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Disinhibition of Eating||-2.76|-4.44|<0.001
71039144|NCT01586039|141586063|SUPERIORITY|||||||0.73||||||Contrasting LED vs. CFL at 90 lux intensity|t-test, 2 sided|Paired t-test.||Contrasting LED vs. CFL at 90 lux intensity. Melatonin suppression is measured as the percentage of melatonin AUC relative to the AUC measured in dim light on the previous day. Higher values indicate more light-induced melatonin suppression.||||0.73
71039145|NCT01586039|141586063|SUPERIORITY|||||||0.001||||||Contrasting LED vs. CFL at 50 lux intensity|t-test, 2 sided|Paired t-test||Contrasting LED vs. CFL at 50 lux intensity||||0.001
71039146|NCT01586039|141586064|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|Paired t-test||||||0.19
71039147|NCT01586039|141586066|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|Paired t-test.||||||0.17
71039148|NCT01586039|141586066|SUPERIORITY|||||||1|||||||t-test, 2 sided|Paired test.||||||1.0
71039149|NCT02442687|141586069|OTHER|||||||0.034||||||The p-value was not adjusted for multiple comparison. The threshold for statistical significance was \<0.05.|ANCOVA|Change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.034
70922947|NCT03857620|141337067|SUPERIORITY||Odds Ratio (OR)|0.46||||0.21|TWO_SIDED|95.0|0.13|1.62|||Mixed Models Analysis|Generalized linear mixed effects model (with logit link function) with a random practice effect to account for clustering within practice||||1.62|0.13|0.21
70990548|NCT01718509|141489462|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-4.21|||<|0.001|TWO_SIDED|95.0|-5.09|-3.33||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Perceived Hunger||-3.33|-5.09|<0.001
70990549|NCT01718509|141489463|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-9.28|||<|0.001|TWO_SIDED|95.0|-11.44|-7.12||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||||-7.12|-11.44|<0.001
71039150|NCT02442687|141586069|OTHER|||||||0.1731||||||The p-value was not adjusted for multiple comparison. The threshold for statistical significance was \<0.05.|ANCOVA|Change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.1731
71039151|NCT02442687|141586070|OTHER|||||||0.5276||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was \<0.05.|ANCOVA|The change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.5276
70922948|NCT03857620|141337067|SUPERIORITY||Odds Ratio (OR)|1.03||||0.96|TWO_SIDED|95.0|0.3|3.54|||Mixed Models Analysis|Generalized linear mixed effects model (with logit link function) with a random practice effect to account for clustering within practice||||3.54|0.30|0.96
70922949|NCT03857620|141337067|SUPERIORITY||Odds Ratio (OR)|0.45||||0.19|TWO_SIDED|95.0|0.13|1.54|||Mixed Models Analysis|Generalized linear mixed effects model (with logit link function) with a random practice effect to account for clustering within practice||||1.54|0.13|0.19
70922950|NCT00567398|141337073|SUPERIORITY||Mean Difference (Final Values)|0.6|||<|0.001|TWO_SIDED|95.0|0.2|0.9|||ANOVA|||Month 3||0.9|0.2|<0.001
70922951|NCT00567398|141337073|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.006|TWO_SIDED|95.0|0.1|0.8|||ANOVA|||Month 6||0.8|0.1|0.006
70922952|NCT00567398|141337074|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.312|TWO_SIDED|95.0|-4.7|14.7|||ANOVA|||Insulin-Month 3||14.7|-4.7|0.312
70922953|NCT00567398|141337074|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.342|TWO_SIDED|95.0|-5.0|14.4|||ANOVA|||Insulin-Month 6||14.4|-5.0|0.342
70922954|NCT00567398|141337076|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.01|TWO_SIDED|95.0|0.1|0.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 3||0.9|0.1|0.010
71039152|NCT02442687|141586070|OTHER|||||||0.4968||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was \<0.05.|ANCOVA|The change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.4968
71039153|NCT02442687|141586071|OTHER|||||||0.2591||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was \<0.05.|ANCOVA|Change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.2591
71039154|NCT02442687|141586071|OTHER|||||||0.1806||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was \<0.05.|ANCOVA|Change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.1806
71039155|NCT02442687|141586072|OTHER|||||||0.0882||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was \<0.05.|ANCOVA|The change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.0882
70922955|NCT00567398|141337076|SUPERIORITY||Median Difference (Final Values)|0.3||||0.073|TWO_SIDED|95.0|0.0|0.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 6||0.7|0|0.073
70922956|NCT00567398|141337076|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.181|TWO_SIDED|95.0|-0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 3||0.5|-0.1|0.181
70922957|NCT00567398|141337076|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.593|TWO_SIDED|95.0|-0.2|0.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 6||0.4|-0.2|0.593
70922958|NCT00567398|141337076|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.198|TWO_SIDED|95.0|-0.2|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 3||0|-0.2|0.198
70990550|NCT01718509|141489464|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.96||||0.298|TWO_SIDED|95.0|-2.77|0.85||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|ANCOVA|||||0.85|-2.77|0.298
70990551|NCT05209932|141489472|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.02|TWO_SIDED||||||ANCOVA|||||||0.02
70990552|NCT05209932|141489473|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.05|TWO_SIDED||||||ANCOVA|||||||0.05
70990553|NCT05209932|141489474|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.07||0.07|TWO_SIDED||||||ANCOVA|||||||0.07
70990554|NCT05209932|141489475|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.12||0.17|TWO_SIDED||||||ANCOVA|||||||0.17
70990555|NCT05209932|141489476|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED||||||ANCOVA|||||||0.002
70990556|NCT05209932|141489477|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.1||0.03|TWO_SIDED||||||ANCOVA|||||||0.03
70922959|NCT00567398|141337076|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.298|TWO_SIDED|95.0|-0.1|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 6||0|-0.1|0.298
70922960|NCT00567398|141337076|SUPERIORITY||Mean Difference (Final Values)|0.4|||<|0.001|TWO_SIDED|95.0|0.2|0.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 3||0.6|0.2|<0.001
70922961|NCT00567398|141337076|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.003|TWO_SIDED|95.0|0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 6||0.5|0.1|0.003
70922962|NCT00567398|141337076|SUPERIORITY||Mean Difference (Final Values)|0.8|||<|0.001|TWO_SIDED|95.0|0.4|1.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 3||1.3|0.4|<0.001
70922963|NCT00567398|141337076|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.002|TWO_SIDED|95.0|0.3|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 6||1.1|0.3|0.002
70922964|NCT00567398|141337077|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.485|TWO_SIDED|95.0|-8.6|4.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 3||4.1|-8.6|0.485
70922965|NCT00567398|141337077|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.556|TWO_SIDED|95.0|-8.2|4.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 6||4.4|-8.2|0.556
70990557|NCT05209932|141489478|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.09||0.01|TWO_SIDED||||||ANCOVA|||||||0.01
70990558|NCT05209932|141489479|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.38|STANDARD_ERROR_OF_MEAN|0.19||0.04|TWO_SIDED||||||ANCOVA|||||||0.04
70922966|NCT00567398|141337077|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.101|TWO_SIDED|95.0|-1.1|12.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 3||12.2|-1.1|0.101
70922967|NCT00567398|141337077|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.134|TWO_SIDED|95.0|-1.5|11.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 6||11.5|-1.5|0.134
70922968|NCT00567398|141337077|SUPERIORITY||Mean Difference (Final Values)|11.4||||0.004|TWO_SIDED|95.0|3.6|19.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 3||19.2|3.6|0.004
70922969|NCT00567398|141337077|SUPERIORITY||Mean Difference (Final Values)|8.4||||0.03|TWO_SIDED|95.0|0.8|15.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 6||15.9|0.8|0.030
70922970|NCT00567398|141337078|SUPERIORITY||Mean Difference (Final Values)|-56.5||||0.655|TWO_SIDED|95.0|-304.6|191.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 3||191.7|-304.6|0.655
70922971|NCT00567398|141337078|SUPERIORITY||Mean Difference (Final Values)|-29.2||||0.811|TWO_SIDED|95.0|-268.9|210.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 6||210.5|-268.9|0.811
70922972|NCT00567398|141337078|SUPERIORITY||Mean Difference (Final Values)|441.3||||0.419|TWO_SIDED|95.0|-630.4|1513.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 3||1513.1|-630.4|0.419
70990559|NCT05209932|141489480|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.1||0.02|TWO_SIDED||||||ANCOVA|||||||0.02
70990560|NCT05209932|141489481|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.13||0.002|TWO_SIDED||||||ANCOVA|||||||0.002
70990561|NCT05209932|141489482|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.1||0.43|TWO_SIDED||||||ANCOVA|||||||0.43
71098680|NCT01654250|141705824|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|2.28||0.496|TWO_SIDED|95.0|-6.0|2.9|||Mixed Models Analysis|||Hour 13 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||2.9|-6.0|0.496
71098681|NCT01654250|141705824|SUPERIORITY_OR_OTHER|||||||0.133|||||||Mixed Models Analysis|||Hour 13 post-dose: Adjusted p-value were generated using a fixed sequence testing procedure from p-values generated from the mixed effects model.||||0.133
71098682|NCT01654250|141705825|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.56||0.007|TWO_SIDED|95.0|-2.6|-0.4|||Mixed Models Analysis|||Hour 0.75 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-0.4|-2.6|0.007
70922973|NCT00567398|141337078|SUPERIORITY||Mean Difference (Final Values)|121.8||||0.82|TWO_SIDED|95.0|-927.9|1171.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 6||1171.5|-927.9|0.820
70922974|NCT00567398|141337079|SUPERIORITY||Mean Difference (Final Values)|-4.2||||0.721|TWO_SIDED|95.0|-27.5|19.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 3||19|-27.5|0.721
70922975|NCT00567398|141337079|SUPERIORITY||Mean Difference (Final Values)|13.5||||0.247|TWO_SIDED|95.0|-9.4|36.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 6||36.4|-9.4|0.247
70922976|NCT00567398|141337080|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.624|TWO_SIDED|95.0|0.55|1.43|||ANOVA|||Estimates of Ratio-Month 6||1.43|0.55|0.624
70922977|NCT00567398|141337081|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.338|TWO_SIDED|95.0|-0.6|1.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 3||1.8|-0.6|0.338
70922978|NCT00567398|141337081|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.029|TWO_SIDED|95.0|0.1|2.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 6||2.5|0.1|0.029
70922979|NCT00567398|141337081|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.817|TWO_SIDED|95.0|-1.9|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 3||1.5|-1.9|0.817
70922980|NCT00567398|141337081|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.091|TWO_SIDED|95.0|-0.2|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 6||2.9|-0.2|0.091
70922981|NCT00567398|141337082|SUPERIORITY||Mean Difference (Final Values)|-10.2||||0.127|TWO_SIDED|95.0|-23.3|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 3||2.9|-23.3|0.127
70922982|NCT00567398|141337082|SUPERIORITY||Mean Difference (Final Values)|-10.3|||<|0.001|TWO_SIDED|95.0|-16.4|-4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 6||-4.3|-16.4|<0.001
70922983|NCT00567398|141337082|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.012|TWO_SIDED|95.0|-0.4|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 3||-0.1|-0.4|0.012
70922984|NCT00567398|141337082|SUPERIORITY||Mean Difference (Final Values)|-0.2|||<|0.001|TWO_SIDED|95.0|-0.3|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 6||-0.1|-0.3|<0.001
70990562|NCT05209932|141489483|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.14||0.12|TWO_SIDED||||||ANCOVA|||||||0.12
71098683|NCT01654250|141705825|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|-3.6|-1.4|||Mixed Models Analysis|||Hour 2 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-1.4|-3.6|<0.001
70990563|NCT05209932|141489484|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.08||0.03|TWO_SIDED||||||ANCOVA|||||||0.03
70990564|NCT05209932|141489485|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.13||0.63|TWO_SIDED||||||ANCOVA|||||||0.63
70990565|NCT05209932|141489486|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-0.85|STANDARD_ERROR_OF_MEAN|0.8||0.29|TWO_SIDED||||||ANCOVA|||||||0.29
70990566|NCT05209932|141489487|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-1.08|STANDARD_ERROR_OF_MEAN|1.12||0.33|TWO_SIDED||||||ANCOVA|||||||0.33
70990567|NCT05209932|141489488|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-2.92|STANDARD_ERROR_OF_MEAN|1.03||0.005|TWO_SIDED||||||ANCOVA|||||||0.005
70990568|NCT05209932|141489489|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.42|TWO_SIDED||||||ANCOVA|||||||0.42
70990569|NCT05209932|141489490|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.3||0.97|TWO_SIDED||||||ANCOVA|||||||0.97
70990570|NCT03848221|141489491|EQUIVALENCE|||||||0.3|||||||ANOVA|||||||0.30
70990571|NCT03848221|141489492|EQUIVALENCE|||||||0.0002|||||||ANOVA|||||||0.0002
70990572|NCT01219959|141489540|SUPERIORITY||Mean Difference (Final Values)|0.6|||<|0.001|TWO_SIDED|95.0|0.2|0.9|||ANOVA|||Month 3||0.9|0.2|<0.001
70990573|NCT01219959|141489540|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.006|TWO_SIDED|95.0|0.1|0.8|||ANOVA|||Month 6||0.8|0.1|0.006
70990574|NCT01219959|141489541|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.312|TWO_SIDED|95.0|-4.7|14.7|||ANOVA|||Insulin-Month 3||14.7|-4.7|0.312
70990575|NCT01219959|141489541|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.342|TWO_SIDED|95.0|-5.0|14.4|||ANOVA|||Insulin-Month 6||14.4|-5.0|0.342
70990576|NCT01219959|141489543|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.01|TWO_SIDED|95.0|0.1|0.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 3||0.9|0.1|0.010
70990577|NCT01219959|141489543|SUPERIORITY||Median Difference (Final Values)|0.3||||0.073|TWO_SIDED|95.0|0.0|0.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 6||0.7|0|0.073
70990578|NCT01219959|141489543|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.181|TWO_SIDED|95.0|-0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 3||0.5|-0.1|0.181
70990579|NCT01219959|141489543|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.593|TWO_SIDED|95.0|-0.2|0.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 6||0.4|-0.2|0.593
70990580|NCT01219959|141489543|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.198|TWO_SIDED|95.0|-0.2|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 3||0|-0.2|0.198
71039156|NCT02442687|141586072|OTHER|||||||0.253||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was \<0.05.|ANCOVA|The change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.2530
70990581|NCT01219959|141489543|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.298|TWO_SIDED|95.0|-0.1|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 6||0|-0.1|0.298
70990582|NCT01219959|141489543|SUPERIORITY||Mean Difference (Final Values)|0.4|||<|0.001|TWO_SIDED|95.0|0.2|0.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 3||0.6|0.2|<0.001
70990583|NCT01219959|141489543|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.003|TWO_SIDED|95.0|0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 6||0.5|0.1|0.003
70990584|NCT01219959|141489543|SUPERIORITY||Mean Difference (Final Values)|0.8|||<|0.001|TWO_SIDED|95.0|0.4|1.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 3||1.3|0.4|<0.001
70990585|NCT01219959|141489543|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.002|TWO_SIDED|95.0|0.3|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 6||1.1|0.3|0.002
70990586|NCT01219959|141489544|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.485|TWO_SIDED|95.0|-8.6|4.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 3||4.1|-8.6|0.485
70990587|NCT01219959|141489544|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.556|TWO_SIDED|95.0|-8.2|4.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 6||4.4|-8.2|0.556
70990588|NCT01219959|141489544|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.101|TWO_SIDED|95.0|-1.1|12.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 3||12.2|-1.1|0.101
70990589|NCT01219959|141489544|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.134|TWO_SIDED|95.0|-1.5|11.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 6||11.5|-1.5|0.134
70990590|NCT01219959|141489544|SUPERIORITY||Mean Difference (Final Values)|11.4||||0.004|TWO_SIDED|95.0|3.6|19.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 3||19.2|3.6|0.004
70990591|NCT01219959|141489544|SUPERIORITY||Mean Difference (Final Values)|8.4||||0.03|TWO_SIDED|95.0|0.8|15.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 6||15.9|0.8|0.030
70990592|NCT01219959|141489545|SUPERIORITY||Mean Difference (Final Values)|-56.5||||0.655|TWO_SIDED|95.0|-304.6|191.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 3||191.7|-304.6|0.655
71039157|NCT00354835|141586101|SUPERIORITY_OR_OTHER_LEGACY||The incidence of anemia|0.2613|||||ONE_SIDED|95.0||0.31||||||Compare incidence of Anemia to historical rate of 0.40 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. Comparing the incidence of anemia with VAC on ARST0531 to the historical rate of 0.40 with VAC on D9803. The 95% one-sided confidence interval for the incidence of anemia will be calculated and evaluated to see if the interval contains the null rate of 0.40.||0.31||
71039158|NCT00354835|141586101|SUPERIORITY_OR_OTHER_LEGACY||The incidence of nausea or hepatopathy|0.027|||||ONE_SIDED|95.0||0.0449||||||Compare incidence of Nausea or Hepatopathy to historical rate of 0.05 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of nausea or hepatopathy will be calculated and evaluated to see if the interval contains the null rate of 0.05.||0.0449||
70990593|NCT01219959|141489545|SUPERIORITY||Mean Difference (Final Values)|-29.2||||0.811|TWO_SIDED|95.0|-268.9|210.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 6||210.5|-268.9|0.811
70990594|NCT01219959|141489545|SUPERIORITY||Mean Difference (Final Values)|441.3||||0.419|TWO_SIDED|95.0|-630.4|1513.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 3||1513.1|-630.4|0.419
70990595|NCT01219959|141489545|SUPERIORITY||Mean Difference (Final Values)|121.8||||0.82|TWO_SIDED|95.0|-927.9|1171.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 6||1171.5|-927.9|0.820
70990596|NCT01219959|141489546|SUPERIORITY||Mean Difference (Final Values)|-4.2||||0.721|TWO_SIDED|95.0|-27.5|19.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 3||19|-27.5|0.721
70990597|NCT01219959|141489546|SUPERIORITY||Mean Difference (Final Values)|13.5||||0.247|TWO_SIDED|95.0|-9.4|36.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 6||36.4|-9.4|0.247
70990598|NCT01219959|141489547|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.624|TWO_SIDED|95.0|0.55|1.43|||ANOVA|||Estimates of Ratio-Month 6||1.43|0.55|0.624
70990599|NCT01219959|141489548|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.338|TWO_SIDED|95.0|-0.6|1.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 3||1.8|-0.6|0.338
71039159|NCT00354835|141586101|SUPERIORITY_OR_OTHER_LEGACY||The incidence of febrile neutropenia|0.1351|||||ONE_SIDED|95.0||0.1729||||||Compare incidence of Febrile Neutropenia to historical rate of 0.50 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of febrile neutropenia will be calculated and evaluated to see if the interval contains the null rate of 0.50.||0.1729||
71039160|NCT00354835|141586101|SUPERIORITY_OR_OTHER_LEGACY||The incidence of platelet count decrease|0.1216|||||ONE_SIDED|95.0||0.1577||||||Compare incidence of Platelet Count Decreased to historical rate of 0.70 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of platelet count decreased will be calculated and evaluated to see if the interval contains the null rate of 0.70.||0.1577||
70990600|NCT01219959|141489548|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.029|TWO_SIDED|95.0|0.1|2.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 6||2.5|0.1|0.029
70990601|NCT01219959|141489548|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.817|TWO_SIDED|95.0|-1.9|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 3||1.5|-1.9|0.817
70990602|NCT01219959|141489548|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.091|TWO_SIDED|95.0|-0.2|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 6||2.9|-0.2|0.091
70990603|NCT01219959|141489549|SUPERIORITY||Mean Difference (Final Values)|-10.2||||0.127|TWO_SIDED|95.0|-23.3|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 3||2.9|-23.3|0.127
70990604|NCT01219959|141489549|SUPERIORITY||Mean Difference (Final Values)|-10.3|||<|0.001|TWO_SIDED|95.0|-16.4|-4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 6||-4.3|-16.4|<0.001
70990605|NCT01219959|141489549|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.012|TWO_SIDED|95.0|-0.4|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 3||-0.1|-0.4|0.012
70990606|NCT01219959|141489549|SUPERIORITY||Mean Difference (Final Values)|-0.2|||<|0.001|TWO_SIDED|95.0|-0.3|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 6||-0.1|-0.3|<0.001
70990607|NCT01219959|141489550|SUPERIORITY||Mean Difference (Final Values)|3.2||||0.019|TWO_SIDED|95.0|0.5|5.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 3||5.8|0.5|0.019
70990608|NCT01219959|141489550|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.019|TWO_SIDED|95.0|0.5|5.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 6||5.6|0.5|0.019
70990609|NCT01219959|141489551|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.884|TWO_SIDED|95.0|-3.9|3.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 3||3.4|-3.9|0.884
71039161|NCT00354835|141586101|SUPERIORITY_OR_OTHER_LEGACY||The incidence of vomiting|0.0405|||||ONE_SIDED|95.0||0.0623||||||Compare incidence of Vomiting to historical rate of 0.15 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of vomiting will be calculated and evaluated to see if the interval contains the null rate of 0.15.||0.0623||
70990610|NCT01219959|141489551|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.716|TWO_SIDED|95.0|-3.0|4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 6||4.3|-3|0.716
70990611|NCT01219959|141489552|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.961|TWO_SIDED|95.0|-1.2|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 3||1.1|-1.2|0.961
70990612|NCT01219959|141489552|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.581|TWO_SIDED|95.0|-0.8|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 6||1.5|-0.8|0.581
70990613|NCT01219959|141489553|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.871|TWO_SIDED|95.0|-3.7|3.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Waist Circumference-Month 6||3.1|-3.7|0.871
70990614|NCT01219959|141489554|SUPERIORITY||Mean Difference (Final Values)|5.2||||0.608|TWO_SIDED|95.0|-14.7|25.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 3||25|-14.7|0.608
70990615|NCT01219959|141489554|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.731|TWO_SIDED|95.0|-11.5|8.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 6||8.1|-11.5|0.731
70990616|NCT01219959|141489554|SUPERIORITY||Mean Difference (Final Values)|185.3||||0.377|TWO_SIDED|95.0|-227.5|598.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 3||598.1|-227.5|0.377
70990617|NCT01219959|141489554|SUPERIORITY||Mean Difference (Final Values)|-18.3||||0.854|TWO_SIDED|95.0|-214.4|177.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 6||177.8|-214.4|0.854
70990618|NCT01219959|141489555|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.412|TWO_SIDED|95.0|-0.03|0.07|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 3||0.07|-0.03|0.412
70990619|NCT01219959|141489555|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.485|TWO_SIDED|95.0|-0.07|0.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 6||0.03|-0.07|0.485
70990620|NCT01219959|141489556|SUPERIORITY||Mean Difference (Final Values)|2.18||||0.525|TWO_SIDED|95.0|-4.56|8.93|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 3||8.93|-4.56|0.525
70990621|NCT01219959|141489556|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.995|TWO_SIDED|95.0|-6.79|6.83|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 6||6.83|-6.79|0.995
70990622|NCT01219959|141489557|SUPERIORITY||Mean Difference (Final Values)|-1.87||||0.526|TWO_SIDED|95.0|-7.64|3.91|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 3||3.91|-7.64|0.526
70990623|NCT01219959|141489557|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.779|TWO_SIDED|95.0|-5.01|6.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 6||6.68|-5.01|0.779
70990624|NCT01219959|141489557|SUPERIORITY||Mean Difference (Final Values)|-2.95||||0.246|TWO_SIDED|95.0|-7.95|2.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 3||2.04|-7.95|0.246
70990625|NCT01219959|141489557|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.78|TWO_SIDED|95.0|-5.78|4.34|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 6||4.34|-5.78|0.780
70990626|NCT01219959|141489557|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.885|TWO_SIDED|95.0|-5.22|6.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 3||6.04|-5.22|0.885
70990627|NCT01219959|141489557|SUPERIORITY||Mean Difference (Final Values)|4.41||||0.128|TWO_SIDED|95.0|-1.28|10.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 6||10.10|-1.28|0.128
70990628|NCT01219959|141489557|SUPERIORITY||Mean Difference (Final Values)|1.07||||0.701|TWO_SIDED|95.0|-4.4|6.54|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 3||6.54|-4.40|0.701
70990629|NCT01219959|141489557|SUPERIORITY||Mean Difference (Final Values)|7.21||||0.01|TWO_SIDED|95.0|1.7|12.73|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 6||12.73|1.70|0.010
70990630|NCT01219959|141489557|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.934|TWO_SIDED|95.0|-4.63|5.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 3||5.03|-4.63|0.934
70990631|NCT01219959|141489557|SUPERIORITY||Mean Difference (Final Values)|3.13||||0.209|TWO_SIDED|95.0|-1.75|8.01|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 6||8.01|-1.75|0.209
70990632|NCT01219959|141489557|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.585|TWO_SIDED|95.0|-4.9|8.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 3||8.68|-4.90|0.585
70990633|NCT01219959|141489557|SUPERIORITY||Mean Difference (Final Values)|1.62||||0.641|TWO_SIDED|95.0|-5.22|8.47|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 6||8.47|-5.22|0.641
70990634|NCT01219959|141489557|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.586|TWO_SIDED|95.0|-6.89|3.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 3||3.90|-6.89|0.586
70990635|NCT01219959|141489557|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.906|TWO_SIDED|95.0|-5.79|5.14|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 6||5.14|-5.79|0.906
70990636|NCT01219959|141489557|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.97|TWO_SIDED|95.0|-4.93|4.75|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 3||4.75|-4.93|0.970
70990637|NCT01219959|141489557|SUPERIORITY||Mean Difference (Final Values)|2.38||||0.34|TWO_SIDED|95.0|-2.52|7.28|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 6||7.28|-2.52|0.340
70990638|NCT01219959|141489558|SUPERIORITY||Mean Difference (Final Values)|24.6||||0.495|TWO_SIDED|95.0|-46.9|96.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Subcutaneous Fat Volume-Month 6||96|-46.9|0.495
70990639|NCT01219959|141489558|SUPERIORITY||Mean Difference (Final Values)|55.4||||0.081|TWO_SIDED|95.0|-7.0|117.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Visceral Fat Volume-Month 6||117.8|-7|0.081
70990640|NCT01219959|141489559|SUPERIORITY||Mean Difference (Final Values)|6.3||||0.626|TWO_SIDED|95.0|-19.3|31.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Diastolic Volume-Month 6||31.9|-19.3|0.626
70990641|NCT01219959|141489559|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.486|TWO_SIDED|95.0|-14.5|30.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Systolic Volume-Month 6||30.1|-14.5|0.486
70990642|NCT01219959|141489560|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.832|TWO_SIDED|95.0|-18.9|23.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass with Pap Muscles-Month 6||23.4|-18.9|0.832
70990643|NCT01219959|141489560|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.82|TWO_SIDED|95.0|-18.3|23.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass without Pap Muscles-Month 6||23.1|-18.3|0.820
70990644|NCT01219959|141489561|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.955|TWO_SIDED|95.0|-6.9|6.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Ejection Fraction-Month 6||6.5|-6.9|0.955
70990645|NCT05906732|141489568|SUPERIORITY||LS Mean|-9.6||||0.003|TWO_SIDED||||||Mixed Models Analysis|||||||0.0030
70990646|NCT05906732|141489569|SUPERIORITY||LS Mean|-6.5||||0.0266|TWO_SIDED||||||Mixed Models Analysis|||||||0.0266
70990647|NCT05906732|141489570|SUPERIORITY||LS Mean|-7.8||||0.0067|TWO_SIDED||||||Mixed Models Analysis|||||||0.0067
70990648|NCT05906732|141489571|SUPERIORITY||LS Mean|-3.9||||0.1106|TWO_SIDED||||||Mixed Models Analysis|||||||0.1106
70990649|NCT05906732|141489572|SUPERIORITY||LS Mean|-4.2||||0.0908|TWO_SIDED||||||Mixed Models Analysis|||||||0.0908
70990650|NCT05906732|141489573|SUPERIORITY||LS Mean|-1.2||||0.4038|TWO_SIDED||||||Mixed Models Analysis|||||||0.4038
70990651|NCT05906732|141489574|SUPERIORITY||LS Mean|1.5||||0.6255|TWO_SIDED||||||Mixed Models Analysis|||||||0.6255
70990652|NCT05906732|141489575|SUPERIORITY||LS Mean|0.2||||0.514|TWO_SIDED||||||Mixed Models Analysis|||||||0.5140
70990653|NCT05906732|141489576|SUPERIORITY||LS Mean|0.8||||0.5675|TWO_SIDED||||||Mixed Models Analysis|||||||0.5675
70990654|NCT05906732|141489577|SUPERIORITY||LS Mean|3.4||||0.764|TWO_SIDED||||||Mixed Models Analysis|||||||0.7640
70990655|NCT05906732|141489578|SUPERIORITY||LS Mean|-2.8||||0.2437|TWO_SIDED||||||Mixed Models Analysis|||||||.2437
70990656|NCT05906732|141489579|SUPERIORITY||LS Mean|-0.8||||0.4229|TWO_SIDED||||||Mixed Models Analysis|||||||0.4229
70990657|NCT05906732|141489580|SUPERIORITY||LS Mean|-0.1||||0.4887|TWO_SIDED||||||Mixed Models Analysis|||||||0.4887
70990658|NCT05906732|141489581|SUPERIORITY||LS Mean|-3.1||||0.2042|TWO_SIDED||||||Mixed Models Analysis|||||||0.2042
71098684|NCT01654250|141705825|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|-3.4|-1.2|||Mixed Models Analysis|||Hour 4 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-1.2|-3.4|<0.001
70990659|NCT05906732|141489582|SUPERIORITY||Mean Difference (Net)|-2.2||||0.2644|TWO_SIDED||||||Mixed Models Analysis|||||||0.2644
70990660|NCT05906732|141489600|SUPERIORITY||Mean Difference (Net)|4.28||||0.3169|TWO_SIDED||||||t-test, 2 sided|||||||0.3169
70990661|NCT05906732|141489601|SUPERIORITY||Mean Difference (Net)|6.78||||0.1066|TWO_SIDED||||||t-test, 2 sided|||||||0.1066
70990662|NCT05906732|141489602|SUPERIORITY||Mean Difference (Net)|-16.06||||0.0443|TWO_SIDED||||||t-test, 2 sided|||||||0.0443
70990663|NCT05906732|141489603|SUPERIORITY||Mean Difference (Net)|-9.06||||0.0815|TWO_SIDED||||||t-test, 2 sided|||||||0.0815
70990664|NCT05906732|141489604|SUPERIORITY||Mean Difference (Net)|-10.67||||0.0137|TWO_SIDED||||||t-test, 2 sided|||||||0.0137
70990665|NCT05906732|141489605|SUPERIORITY||Mean Difference (Net)|-4.0||||0.3539|TWO_SIDED||||||t-test, 2 sided|||||||0.3539
70990666|NCT05906732|141489606|SUPERIORITY||Mean Difference (Net)|9.78||||0.1377|TWO_SIDED||||||t-test, 2 sided|||||||0.1377
70990667|NCT05906732|141489607|SUPERIORITY||Mean Difference (Net)|-2.69||||0.6184|TWO_SIDED||||||t-test, 2 sided|||||||0.6184
70990668|NCT05906732|141489608|SUPERIORITY||Mean Difference (Net)|3.17||||0.6627|TWO_SIDED||||||t-test, 2 sided|||||||0.6627
70990669|NCT05906732|141489609|SUPERIORITY||Mean Difference (Net)|5.78||||0.5276|TWO_SIDED||||||t-test, 2 sided|||||||0.5276
70990670|NCT05906732|141489610|SUPERIORITY||Mean Difference (Net)|15.17||||0.0399|TWO_SIDED||||||t-test, 2 sided|||||||0.0399
70990671|NCT05906732|141489611|SUPERIORITY||Mean Difference (Net)|13.56||||0.0747|TWO_SIDED||||||t-test, 2 sided|||||||0.0747
70990672|NCT05906732|141489612|SUPERIORITY|||||||0.9584|||||||t-test, 2 sided|||||||0.9584
70990673|NCT05906732|141489613|SUPERIORITY||Mean Difference (Net)|5.72||||0.6531|TWO_SIDED||||||t-test, 2 sided|||||||0.6531
70990674|NCT05906732|141489614|SUPERIORITY||Mean Difference (Net)|15.61||||0.0482|TWO_SIDED||||||t-test, 2 sided|||||||0.0482
70990675|NCT05906732|141489615|SUPERIORITY||Mean Difference (Net)|17.22||||0.0667|TWO_SIDED||||||t-test, 2 sided|||||||0.0667
70990676|NCT05906732|141489616|SUPERIORITY||Mean Difference (Net)|-37.0||||0.0131|TWO_SIDED||||||t-test, 2 sided|||||||0.0131
70990677|NCT05906732|141489617|SUPERIORITY||Mean Difference (Net)|-32.36||||0.0141|TWO_SIDED||||||t-test, 2 sided|||||||0.0141
70990678|NCT05906732|141489618|SUPERIORITY||Mean Difference (Net)|-44.55||||0.0019|TWO_SIDED||||||t-test, 2 sided|||||||0.0019
70990679|NCT05906732|141489619|SUPERIORITY||Mean Difference (Net)|-31.69||||0.1108|TWO_SIDED||||||t-test, 2 sided|||||||0.1108
70990680|NCT05906732|141489620|SUPERIORITY||Mean Difference (Net)|37.81||||0.184|TWO_SIDED||||||t-test, 2 sided|||||||0.1840
70990681|NCT05906732|141489621|SUPERIORITY||Mean Difference (Net)|27.33||||0.2019|TWO_SIDED||||||t-test, 2 sided|||||||0.2019
70990682|NCT05906732|141489622|SUPERIORITY|||||||0.2808|||||||t-test, 2 sided|||||||0.2808
70990683|NCT05906732|141489623|SUPERIORITY||Mean Difference (Net)|110.39||||0.1644|TWO_SIDED||||||t-test, 2 sided|||||||0.1644
70990684|NCT05906732|141489624|SUPERIORITY||Mean Difference (Net)|-44.29||||0.0282|TWO_SIDED||||||t-test, 2 sided|||||||0.0282
70990685|NCT05906732|141489625|SUPERIORITY||Mean Difference (Net)|-37.87||||0.0306|TWO_SIDED||||||t-test, 2 sided|||||||0.0306
70990686|NCT05906732|141489626|SUPERIORITY||Mean Difference (Net)|-53.42||||0.0016|TWO_SIDED||||||t-test, 2 sided|||||||0.0016
70990687|NCT05906732|141489627|SUPERIORITY||Mean Difference (Net)|-44.25||||0.1378|TWO_SIDED||||||t-test, 2 sided|||||||0.1378
70990688|NCT00506077|141489628|SUPERIORITY_OR_OTHER|||||||0.939||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.05 was used among 1 primary and 3 secondary cognition efficacy endpoints to control the false positive rate.|constrained longitudinal data analysis|The model factors were treatment, sequence, period, week (as categorical variable), site, treatment-by-week, sequence-by-week, and period-by-week.||||||0.939
70990689|NCT00506077|141489629|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||P-Value Comments (limit 250 characters): The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.05 was used among 1 primary and 3 secondary cognition efficacy endpoints to control the false positive rate.|constrained Longitudinal Data Analysis|The model factors were treatment, sequence, period, week (as categorical variable), site, treatment-by-week, sequence-by-week, and period-by-week.||||||0.736
70990690|NCT00506077|141489630|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.05 was used among 1 primary and 3 secondary cognition efficacy endpoints to control the false positive rate.|constrained Longitudinal Data Analysis|The model factors were treatment, sequence, period, week (as categorical variable), site, treatment-by-week, sequence-by-week, and period-by-week.||||||0.736
71098685|NCT01654250|141705825|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.56||0.003|TWO_SIDED|95.0|-2.8|-0.6|||Mixed Models Analysis|||Hour 8 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-0.6|-2.8|0.003
70990691|NCT00506077|141489631|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.05 was used among 1 primary and 3 secondary cognition efficacy endpoints to control the false positive rate.|constrained Logitudinal Data Analysis|The model factors were treatment, sequence, period, week (as categorical variable), site, treatment-by-week, sequence-by-week, and period-by-week.||||||0.736
70990692|NCT00818324|141489636|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 2|t-test, 2 sided|||||||<0.001
70990693|NCT00818324|141489636|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 4.|t-test, 2 sided|||||||<0.001
70990694|NCT00818324|141489636|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 28.|t-test, 2 sided|||||||<0.001
70990695|NCT00818324|141489636|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 52.|t-test, 2 sided|||||||<0.001
70990696|NCT00818324|141489637|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 2.|t-test, 2 sided|||||||<0.001
70990697|NCT00818324|141489637|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 4.|t-test, 2 sided|||||||<0.001
70990698|NCT00818324|141489637|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 28.|t-test, 2 sided|||||||<0.001
70990699|NCT00818324|141489637|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 52.|t-test, 2 sided|||||||<0.001
70990700|NCT01212172|141489664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9||||0.2879|TWO_SIDED|95.0|-6.7|21.1|||t-test, 1 sided|||||21.1|-6.7|0.2879
70990701|NCT02868216|141489684|OTHER||Mean Difference (Final Values)|2.3|STANDARD_DEVIATION|0.84||0.05|TWO_SIDED|95.0|0.63|3.98|||ANOVA|||||3.98|0.63|0.05
70990702|NCT03238235|141489729|SUPERIORITY||Log Difference of the least square means|0.04||||0.8282|TWO_SIDED|95.0|-0.3|0.38||ANCOVA model was performed considering the difference between log of total fibrosis and log baseline values as dependent variable; log baseline value was included as covariate, treatment and concomitant steroid use as independent class variables.|ANCOVA|||total fibrosis at visit 11||0.38|-0.30|0.8282
70990703|NCT03238235|141489729|SUPERIORITY|Mixed model was performed considering the difference between log Visit 11 and log baseline values as dependent variable; log baseline as covariate, treatment was included as independent class variable and treatment by sequence interaction. The sequence of biopsy site (R-L, L-R) was included as a fixed effect and subject as a random effect. If the treatment by sequence interaction was p\>0.10, then the model without the interaction term is presented.|Log Difference of Least Square Means|-0.11||||0.6465|TWO_SIDED|95.0|-0.59|0.37|||Mixed Models Analysis|||A Mixed Model was fitted to the data in order to evaluate the difference in total fibrosis between biopsy sites||0.37|-0.59|0.6465
70990704|NCT03238235|141489730|SUPERIORITY||Log Difference of Least Square Means|-0.05||||0.1991|TWO_SIDED|95.0|-0.12|0.03||ANCOVA model was performed considering baseline fat fraction of vastus lateralis or fat fraction in the soleus value as covariate and treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Vastus lateralis||0.03|-0.12|0.1991
70990705|NCT03238235|141489730|SUPERIORITY||difference of the least square means|-0.27||||0.7849|TWO_SIDED|95.0|-2.22|1.69||ANCOVA model was performed considering baseline fat fraction of vastus lateralis or fat fraction in the soleus value as covariate and treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Soleus||1.69|-2.22|0.7849
70990706|NCT03238235|141489731|SUPERIORITY||Difference of Least Square Means|-1.35||||0.0149|TWO_SIDED|95.0|-2.43|-0.28||ANCOVA model was performed considering baseline Fat Fraction of lower limb muscles value as covariate and treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Whole thigh at visit 11||-0.28|-2.43|0.0149
70990707|NCT03238235|141489731|SUPERIORITY||Difference of Least Square Means|-1.96||||0.0022|TWO_SIDED|95.0|-3.18|-0.75||ANCOVA model was performed considering baseline Fat Fraction of lower limb muscles value as covariate and treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||Quadriceps at visit 11||-0.75|-3.18|0.0022
70990708|NCT03238235|141489731|SUPERIORITY||Difference of least square means|-0.58||||0.4869|TWO_SIDED|95.0|-2.24|1.08||ANCOVA model was performed considering baseline Fat Fraction of lower limb muscles value as covariate and treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Hamstrings at visit 11||1.08|-2.24|0.4869
70990709|NCT03238235|141489731|SUPERIORITY||Difference of Least Square Means|-1.59||||0.0939|TWO_SIDED|95.0|-3.47|0.29||ANCOVA model was performed considering baseline Fat Fraction of lower limb muscles value as covariate and treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Triceps Surae at Visit 11||0.29|-3.47|0.0939
70990710|NCT03238235|141489731|SUPERIORITY||Difference of Least Square Means|-0.89||||0.1579|TWO_SIDED|95.0|-2.13|0.36||ANCOVA model was performed considering baseline Fat Fraction of lower limb muscles value as covariate and treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Pelvis girdle at visit 11||0.36|-2.13|0.1579
70990711|NCT03238235|141489732|SUPERIORITY||Difference of Least Square Means|0.4||||0.777|TWO_SIDED|95.0|-2.45|3.26||ANCOVA model was performed considering baseline CSA as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Whole Thigh at visit 11||3.26|-2.45|0.7770
70990712|NCT03238235|141489732|SUPERIORITY||Difference of Least Square Means|-0.09||||0.8926|TWO_SIDED|95.0|-1.35|1.18||ANCOVA model was performed considering baseline CSA as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||Quadriceps at Visit 11||1.18|-1.35|0.8926
70922985|NCT00567398|141337083|SUPERIORITY||Mean Difference (Final Values)|3.2||||0.019|TWO_SIDED|95.0|0.5|5.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 3||5.8|0.5|0.019
70922986|NCT00567398|141337083|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.019|TWO_SIDED|95.0|0.5|5.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 6||5.6|0.5|0.019
70922987|NCT00567398|141337084|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.884|TWO_SIDED|95.0|-3.9|3.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 3||3.4|-3.9|0.884
70922988|NCT00567398|141337084|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.716|TWO_SIDED|95.0|-3.0|4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 6||4.3|-3|0.716
70922989|NCT00567398|141337085|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.961|TWO_SIDED|95.0|-1.2|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 3||1.1|-1.2|0.961
70922990|NCT00567398|141337085|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.581|TWO_SIDED|95.0|-0.8|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 6||1.5|-0.8|0.581
70922991|NCT00567398|141337086|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.871|TWO_SIDED|95.0|-3.7|3.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Waist Circumference-Month 6||3.1|-3.7|0.871
70922992|NCT00567398|141337087|SUPERIORITY||Mean Difference (Final Values)|5.2||||0.608|TWO_SIDED|95.0|-14.7|25.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 3||25|-14.7|0.608
70922993|NCT00567398|141337087|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.731|TWO_SIDED|95.0|-11.5|8.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 6||8.1|-11.5|0.731
70922994|NCT00567398|141337087|SUPERIORITY||Mean Difference (Final Values)|185.3||||0.377|TWO_SIDED|95.0|-227.5|598.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 3||598.1|-227.5|0.377
70922995|NCT00567398|141337087|SUPERIORITY||Mean Difference (Final Values)|-18.3||||0.854|TWO_SIDED|95.0|-214.4|177.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 6||177.8|-214.4|0.854
70922996|NCT00567398|141337088|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.412|TWO_SIDED|95.0|-0.03|0.07|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 3||0.07|-0.03|0.412
70922997|NCT00567398|141337088|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.485|TWO_SIDED|95.0|-0.07|0.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 6||0.03|-0.07|0.485
70922998|NCT00567398|141337089|SUPERIORITY||Mean Difference (Final Values)|2.18||||0.525|TWO_SIDED|95.0|-4.56|8.93|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 3||8.93|-4.56|0.525
70922999|NCT00567398|141337089|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.995|TWO_SIDED|95.0|-6.79|6.83|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 6||6.83|-6.79|0.995
70923000|NCT00567398|141337090|SUPERIORITY||Mean Difference (Final Values)|-1.87||||0.526|TWO_SIDED|95.0|-7.64|3.91|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 3||3.91|-7.64|0.526
70923001|NCT00567398|141337090|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.779|TWO_SIDED|95.0|-5.01|6.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 6||6.68|-5.01|0.779
70923002|NCT00567398|141337090|SUPERIORITY||Mean Difference (Final Values)|-2.95||||0.246|TWO_SIDED|95.0|-7.95|2.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 3||2.04|-7.95|0.246
70923003|NCT00567398|141337090|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.78|TWO_SIDED|95.0|-5.78|4.34|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 6||4.34|-5.78|0.780
70923004|NCT00567398|141337090|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.885|TWO_SIDED|95.0|-5.22|6.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 3||6.04|-5.22|0.885
70923005|NCT00567398|141337090|SUPERIORITY||Mean Difference (Final Values)|4.41||||0.128|TWO_SIDED|95.0|-1.28|10.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 6||10.10|-1.28|0.128
70923006|NCT00567398|141337090|SUPERIORITY||Mean Difference (Final Values)|1.07||||0.701|TWO_SIDED|95.0|-4.4|6.54|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 3||6.54|-4.40|0.701
70923007|NCT00567398|141337090|SUPERIORITY||Mean Difference (Final Values)|7.21||||0.01|TWO_SIDED|95.0|1.7|12.73|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 6||12.73|1.70|0.010
70923008|NCT00567398|141337090|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.934|TWO_SIDED|95.0|-4.63|5.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 3||5.03|-4.63|0.934
70923009|NCT00567398|141337090|SUPERIORITY||Mean Difference (Final Values)|3.13||||0.209|TWO_SIDED|95.0|-1.75|8.01|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 6||8.01|-1.75|0.209
70923010|NCT00567398|141337090|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.585|TWO_SIDED|95.0|-4.9|8.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 3||8.68|-4.90|0.585
70923011|NCT00567398|141337090|SUPERIORITY||Mean Difference (Final Values)|1.62||||0.641|TWO_SIDED|95.0|-5.22|8.47|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 6||8.47|-5.22|0.641
70923012|NCT00567398|141337090|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.586|TWO_SIDED|95.0|-6.89|3.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 3||3.90|-6.89|0.586
70923013|NCT00567398|141337090|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.906|TWO_SIDED|95.0|-5.79|5.14|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 6||5.14|-5.79|0.906
70923014|NCT00567398|141337090|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.97|TWO_SIDED|95.0|-4.93|4.75|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 3||4.75|-4.93|0.970
70923015|NCT00567398|141337090|SUPERIORITY||Mean Difference (Final Values)|2.38||||0.34|TWO_SIDED|95.0|-2.52|7.28|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 6||7.28|-2.52|0.340
70990713|NCT03238235|141489732|SUPERIORITY||Difference of Least Square Means|0.35||||0.572|TWO_SIDED|95.0|-0.88|1.58||ANCOVA model was performed considering baseline CSA as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Medial Thigh at Visit 11||1.58|-0.88|0.5720
70990714|NCT03238235|141489732|SUPERIORITY||Difference of Least Square Means|0.11||||0.8386|TWO_SIDED|95.0|-0.97|1.18||ANCOVA model was performed considering baseline CSA as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Hamstrings at Visit 11||1.18|-0.97|0.8386
70990715|NCT03238235|141489732|SUPERIORITY||Difference of Least Square Means|-0.22||||0.8591|TWO_SIDED|95.0|-2.68|2.25||ANCOVA model was performed considering baseline CSA as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||Triceps Surae at Visit 11||2.25|-2.68|0.8591
70990716|NCT03238235|141489732|SUPERIORITY||Difference of Least Square Means|0.32||||0.7392|TWO_SIDED|95.0|-1.6|2.24|||ANCOVA|||Pelvis Girdle at Visit 11||2.24|-1.60|0.7392
70990717|NCT03238235|141489733|SUPERIORITY||Difference of Least Square Means|1.37||||0.0375|TWO_SIDED|95.0|0.08|2.65||ANCOVA model was performed considering baseline Contractile Area value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Whole Thigh at Visit 11||2.65|0.08|0.0375
70990718|NCT03238235|141489733|SUPERIORITY||difference of least square means|0.63||||0.0528|TWO_SIDED|95.0|-0.01|1.27||ANCOVA model was performed considering baseline Contractile Area value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Quadriceps at Visit 11||1.27|-0.01|0.0528
70990719|NCT03238235|141489733|SUPERIORITY||Difference of Least Square Means|0.36||||0.2012|TWO_SIDED|95.0|-0.2|0.91||ANCOVA model was performed considering baseline Contractile Area value as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||Medial Thigh at Visit 11||0.91|-0.20|0.2012
70990720|NCT03238235|141489733|SUPERIORITY||Difference of Least Square Means|0.75||||0.4676|TWO_SIDED|95.0|-1.33|2.83||ANCOVA model was performed considering baseline Contractile Area value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Triceps Surae at Visit 11||2.83|-1.33|0.4676
70990721|NCT03238235|141489733|SUPERIORITY||Difference of Least Square Means|0.54||||0.1549|TWO_SIDED|95.0|-0.21|1.3||ANCOVA model was performed considering baseline Contractile Area value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Pelvis Girdle at Visit 11||1.30|-0.21|0.1549
70990722|NCT03238235|141489734|SUPERIORITY||Difference of Least Square Means|-619.2||||0.324|TWO_SIDED|95.0|-1872.37|633.98||ANCOVA model was performed considering baseline biopsy histological parameters (Slide III) value as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||CSA Type II at Visit 11||633.98|-1872.37|0.3240
70990723|NCT03238235|141489734|SUPERIORITY||Difference of Least Square Means|-572.54||||0.307|TWO_SIDED|95.0|-1690.73|545.64||ANCOVA model was performed considering baseline biopsy histological parameters (Slide III) value as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||Total CSA at Visit 11||545.64|-1690.73|0.3070
70990724|NCT03238235|141489735|SUPERIORITY||Log Difference of Least Square Means|-0.27||||0.1055|TWO_SIDED|95.0|-0.59|0.06||ANCOVA model was performed considering baseline Biopsy histological parameters (Slide I) value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Fibers with nuclear centralizations (%) at Visit 11||0.06|-0.59|0.1055
70990725|NCT03238235|141489735|SUPERIORITY||Difference of Least Square Means|-2.23||||0.8846|TWO_SIDED|95.0|-33.05|28.59||ANCOVA model was performed considering baseline biopsy histological parameters (Slide II) value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Total number of fibers at Visit 11 (slide II)||28.59|-33.05|0.8846
70990726|NCT03238235|141489735|SUPERIORITY||Difference of Least Square Means|4.72||||0.4054|TWO_SIDED|95.0|-6.62|16.06||ANCOVA model was performed considering baseline biopsy histological parameters (Slide III) value as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||Total number of fibers (Slide III)||16.06|-6.62|0.4054
70990727|NCT03238235|141489736|SUPERIORITY||Difference of Least Square Means|2.45||||0.634|TWO_SIDED|95.0|-7.87|12.77||ANCOVA model was performed considering baseline Biopsy histological parameters (Slide I) value as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||||12.77|-7.87|0.6340
70990728|NCT03238235|141489737|SUPERIORITY||Log Difference of Least Square Means|-0.14||||0.4893|TWO_SIDED|95.0|-0.54|0.26|||ANCOVA|||||0.26|-0.54|0.4893
70990729|NCT03238235|141489738|SUPERIORITY||Log Difference of Least Square Means|-0.34||||0.1498|TWO_SIDED|95.0|-0.81|0.13||This model was performed considering baseline biopsy histological parameters (Slide I) value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||||0.13|-0.81|0.1498
71039162|NCT00354835|141586101|SUPERIORITY_OR_OTHER_LEGACY||The incidence of anemia|0.2798|||||ONE_SIDED|95.0||0.3329||||||Compare incidence of Anemia to historical rate of 0.40 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. 95% one-sided confidence interval for the incidence of anemia will be calculated and evaluated to see if the interval contains the null rate of 0.40.||0.3329||
70990730|NCT03238235|141489739|SUPERIORITY||Log Difference of Least Square Means|0.06||||0.0602|TWO_SIDED|95.0|0.0|0.13||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|Mixed Models Analysis|||Standing and transfers (D1) at Visit 11||0.13|-0.00|0.0602
70990731|NCT03238235|141489739|SUPERIORITY||Log Difference of Least Square Means|0.0||||0.5906|TWO_SIDED|95.0|-0.01|0.01||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|Mixed Models Analysis|||Axial and proximal motor function (D2) at Visit 11||0.01|-0.01|0.5906
70990732|NCT03238235|141489739|SUPERIORITY||Log Difference of Least Square Means|0.0||||0.7799|TWO_SIDED|95.0|-0.01|0.01||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|Mixed Models Analysis|||Distal motor function (D3) at Visit 11||0.01|-0.01|0.7799
70990733|NCT03238235|141489739|SUPERIORITY||Log Difference of Least Square Means|0.01||||0.1116|TWO_SIDED|95.0|0.0|0.03||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|Mixed Models Analysis|||Total Score at Visit 11||0.03|-0.00|0.1116
70990734|NCT03238235|141489740|SUPERIORITY||Log Difference of Least Square Means|-0.07||||0.4346|TWO_SIDED|95.0|-0.23|0.1||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate|Mixed Models Analysis|||Time to Walk/Run 10 meters at Visit 11||0.10|-0.23|0.4346
70990735|NCT03238235|141489741|SUPERIORITY||Log Difference of Least Square Means|-0.02||||0.8914|TWO_SIDED|95.0|-0.32|0.28|||Mixed Models Analysis|||Time to climb 4 standard steps (sec) at visit 11||0.28|-0.32|0.8914
70990736|NCT03238235|141489742|SUPERIORITY||Difference of Least Square Means|0.62||||0.7629|TWO_SIDED|95.0|-3.51|4.75||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|Mixed Models Analysis|||Time to rise from floor at Visit 11||4.75|-3.51|0.7629
70990737|NCT03238235|141489743|SUPERIORITY||Log Difference of Least Square Means|-0.01||||0.8106|TWO_SIDED|95.0|-0.11|0.08||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate|Mixed Models Analysis|||Maximum distance walked after 6 minutes at Visit 11||0.08|-0.11|0.8106
70990738|NCT03238235|141489744|SUPERIORITY|||||||0.1626||||||P-value is obtained from the two-sided Cochran-Mantel-Haenszel chi-squared test, stratified for concomitant steroid use at baseline|Cochran-Mantel-Haenszel|||\<10% worsening at visit 11||||0.1626
70990739|NCT03238235|141489747|SUPERIORITY||Difference of Least Square Means|3.57||||0.5099|TWO_SIDED|95.0|-7.27|14.41||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|ANCOVA|||Left Knee Extension (N) at Visit 11||14.41|-7.27|0.5099
70990740|NCT03238235|141489747|SUPERIORITY||Difference of Least Square Means|1.16||||0.7355|TWO_SIDED|95.0|-5.73|8.06||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|ANCOVA|||Right Knee Extension (N) at Visit 11||8.06|-5.73|0.7355
70990741|NCT03238235|141489747|SUPERIORITY||Difference of Least Square Means|3.92||||0.6037|TWO_SIDED|95.0|-11.22|19.06||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|ANCOVA|||Left Elbow Flexion (N) at Visit 11||19.06|-11.22|0.6037
70990742|NCT03238235|141489747|SUPERIORITY||Difference of Least Square Means|4.1||||0.6178|TWO_SIDED|95.0|-12.35|20.55||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|ANCOVA|||Right Elbow Flexion (N) at Visit 11||20.55|-12.35|0.6178
70990743|NCT03238235|141489750|SUPERIORITY||log difference of Least Square Means|-0.03||||0.1165|TWO_SIDED|95.0|-0.06|0.01||ANCOVA model was performed considering baseline fat fraction of lower limb muscles value as covariate and treatment and concomitant steroids use at baseline as independent class variables|ANCOVA|||Medial Thigh at visit 11||0.01|-0.06|0.1165
70990744|NCT03238235|141489751|SUPERIORITY||Log difference of Least Square Means|0.05||||0.1939|TWO_SIDED|95.0|-0.02|0.12||ANCOVA model was performed considering baseline CSA as covariate and treatment and concomitant steroids use at baseline as independent class variables|ANCOVA|||Hamstrings at Visit 11||0.12|-0.02|0.1939
70990745|NCT03238235|141489752|SUPERIORITY||Log difference of Least Square Means|0.01||||0.9493|TWO_SIDED|95.0|-0.29|0.3||ANCOVA model was performed considering baseline biopsy histological parameters (slide III) value as covariate, treatment and concomitant steroids use at baseline as independent class variables|ANCOVA|||CSA Type I||0.30|-0.29|0.9493
70990746|NCT03238235|141489753|SUPERIORITY||Log difference of Least Square Means|0.05||||0.6265|TWO_SIDED|95.0|-0.16|0.26||ANCOVA model was performed considering baseline biopsy histological parameters (slide I) value as covariate, treatment and concomitant steroids use at baseline as independent class variables|ANCOVA|||Total number of Fibers at Visit 11 (slide I)||0.26|-0.16|0.6265
70990747|NCT03238235|141489753|SUPERIORITY||Log difference of Least Square Means|-0.44||||0.1562|TWO_SIDED|95.0|-1.05|0.17||ANCOVA model was performed considering baseline biopsy histological parameters (slide II) value as covariate, treatment and concomitant steroids use at baseline as independent class variables|ANCOVA|||Regenerative Fibers (%) at Visit 11||0.17|-1.05|0.1562
70990748|NCT02094586|141489760|EQUIVALENCE|The GMT of each lot was required to be within ±50% of each other lot with 95% confidence. Specifically, the 95% CI around each pairwise ratio of GMTs was required to be within \[0.67, 1.5\].|Geometric Mean Ratio|0.92|||||TWO_SIDED|95.0|0.78|1.08||||||Lot A vs. Lot B||1.08|0.78|
70990749|NCT02094586|141489765|EQUIVALENCE|The GMT of each lot was required to be within ±50% of each other lot with 95% confidence. Specifically, the 95% CI around each pairwise ratio of GMTs was required to be within \[0.67, 1.5\].|Geometric Mean Ratio|1.02|||||TWO_SIDED|95.0|0.87|1.2||||||Lot B vs Lot C||1.20|0.87|
70923016|NCT00567398|141337091|SUPERIORITY||Mean Difference (Final Values)|24.6||||0.495|TWO_SIDED|95.0|-46.9|96.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Subcutaneous Fat Volume-Month 6||96|-46.9|0.495
70990750|NCT02094586|141489766|EQUIVALENCE|The GMT of each lot was required to be within ±50% of each other lot with 95% confidence. Specifically, the 95% CI around each pairwise ratio of GMTs was required to be within \[0.67, 1.5\].|Geometric Mean Ratio|0.94|||||TWO_SIDED|95.0|0.8|1.1||||||Lot A vs. Lot C||1.10|0.80|
70990751|NCT02761993|141489767|SUPERIORITY|||||||0.341||||||Since there were two (2) primary hypotheses, Bonferroni corrections were used to control for multiplicity, with p \< 0.025 considered significant.|Generalized Estimating Equation|Generalized estimating equations (GEE) method with a linear link and exchangeable covariance matrix (with subject correlation structure)||||||0.341
70990752|NCT02761993|141489767|SUPERIORITY|||||||0.774||||||Since there were two (2) primary hypotheses, Bonferroni corrections were used to control for multiplicity, with p \< 0.025 considered significant.|Generalized Estimating Equations|Generalized estimating equations (GEE) method with a linear link and exchangeable covariance matrix (with subject correlation structure)||||||0.774
70990753|NCT02761993|141489768|SUPERIORITY|||||||0.501||||||Since there were two (2) primary hypotheses, Bonferroni corrections were used to control for multiplicity, with p \< 0.025 considered significant.|Generalized Estimating Equations|Generalized estimating equations (GEE) method with a linear link and exchangeable covariance matrix (with subject correlation structure)||||||0.501
70990754|NCT02761993|141489768|SUPERIORITY|||||||0.486||||||Since there were two (2) primary hypotheses, Bonferroni corrections were used to control for multiplicity, with p \< 0.025 considered significant.|Generalized Estimating Equations|Generalized estimating equations (GEE) method with a linear link and exchangeable covariance matrix (with subject correlation structure)||||||0.486
70990755|NCT02761993|141489769|SUPERIORITY|||||||0.816|||||||ANCOVA|||||||0.816
70990756|NCT02761993|141489769|SUPERIORITY|||||||0.706|||||||ANCOVA|||||||0.706
70990757|NCT01842620|141489770|EQUIVALENCE|Geometric means ratio for AUC (0-t) of test drug (Oxemet) to be entirely fallen within range of 0.80 to 1.25 of that of reference drug (Glafornil).|(Ratio of AUC0-36)*100|100.0|||||TWO_SIDED|90.0|92.62|107.98|||||Ratio of AUC0-36= (AUC0-36 of Test)/ AUC 0-36 Reference)|Overall period||107.98|92.62|
70990758|NCT01842620|141489771|EQUIVALENCE|Geometric means ratio for AUC(0-inf) of test drug (Oxemet) to be entirely fallen within range of 0.80 to 1.25 of that of reference drug (Glafornil).|(Ratio of AUC0-inf)*100|99.02|||||TWO_SIDED|90.0|92.26|106.27|||||Ratio of AUC0-inf= (AUC0-inf of Test) / (AUC 0-inf of Reference)|For overall period||106.27|92.26|
70990759|NCT01842620|141489772|EQUIVALENCE|Geometric means ratio for Cmax of test drug (Oxemet) to be entirely fallen within range of 0.80 to 1.25 of that of reference drug (Glafornil).|(Ratio of Cmax)*100|98.34|||||TWO_SIDED|90.0|88.54|109.22|||||Ratio of Cmax= (Cmax of Test) / (Cmax of Reference)|Overall period||109.22|88.54|
70990760|NCT03342469|141489781|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Delta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||>0.05
70990761|NCT03342469|141489781|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Theta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||>0.05
70990762|NCT03342469|141489781|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Alpha Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||>0.05
70990763|NCT03342469|141489781|OTHER|||||||0.08||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Beta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||0.08
71039163|NCT00354835|141586101|SUPERIORITY_OR_OTHER_LEGACY||The incidence of nausea or hepatopathy|0.0052|||||ONE_SIDED|95.0||0.0137||||||Compare incidence of Nausea or Hepatopathy to historical rate of 0.05 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of nausea or hepatopathy will be calculated and evaluated to see if the interval contains the null rate of 0.05.||0.0137||
70923017|NCT00567398|141337091|SUPERIORITY||Mean Difference (Final Values)|55.4||||0.081|TWO_SIDED|95.0|-7.0|117.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Visceral Fat Volume-Month 6||117.8|-7|0.081
70990764|NCT03342469|141489781|OTHER|||||||0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|F(1,14)= 4.55||Difference in Gamma Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||0.05
70990765|NCT03342469|141489781|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Delta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||>0.05
70990766|NCT03342469|141489781|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Theta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||>0.05
70990767|NCT03342469|141489781|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Alpha Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||>0.05
70990768|NCT03342469|141489781|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Beta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)||||>0.05
70990769|NCT03342469|141489781|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Gamma Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
70990770|NCT03342469|141489782|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Delta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
70990771|NCT03342469|141489782|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Theta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
70990772|NCT03342469|141489782|OTHER|||||||0.04||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|F(1.14)= 4.88, p=0.04||"Difference in Alpha Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||0.04
70990773|NCT03342469|141489782|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Beta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
70990774|NCT03342469|141489782|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Gamma Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
70990775|NCT03342469|141489782|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Delta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
70990776|NCT03342469|141489782|OTHER||||||>|0.05|||||||repeated measures General Linear Model|||"Difference in Theta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons"||||>0.05
70990777|NCT03342469|141489782|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Alpha Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
70990778|NCT03342469|141489782|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Beta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
70990779|NCT03342469|141489782|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Gamma Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
70990780|NCT03342469|141489783|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|F(1,15) = 3.65, p = 0.08||"Difference in inattentive ASRS in ADHD group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (inattentive ASRS score during AFC, inattentive ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
70990781|NCT03342469|141489783|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in hyperactive ASRS in ADHD group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (hyperactive ASRS score during AFC, hyperactive ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
70990782|NCT03342469|141489783|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in total ASRS in ADHD group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (total ASRS score during AFC, total ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
70990783|NCT03342469|141489783|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"inattentive ASRS in control group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (inattentive ASRS score during AFC, inattentive ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
70990784|NCT03342469|141489783|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Hyperactive ASRS in control group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (hyperactive ASRS score during AFC, hyperactive ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
70990785|NCT03342469|141489783|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in total ASRS in control group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (total ASRS score during AFC, total ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
70990786|NCT03050359|141489784|NON_INFERIORITY|If the lower bound of the 95% CI was ≥-6%, the DU healing rate for TAK-438 was considered to be noninferior to that seen with lansoprazole.|Exact (Clopper-Pearson)|0.4|||||TWO_SIDED|95.0|-2.998|3.791||||||||3.791|-2.998|
70990787|NCT03050359|141489785|NON_INFERIORITY|If the lower bound of the 95% CI was ≥-10%, the HP eradication rate for TAK-438 was considered to be noninferior to that seen with lansoprazole.|Exact (Clopper-Pearson)|4.7|||||TWO_SIDED|95.0|-1.281|10.69||||||||10.690|-1.281|
70990788|NCT03050359|141489786|NON_INFERIORITY|If the lower bound of the 95% CI was ≥-6%, the DU healing rate for TAK-438 was considered to be noninferior to that seen with lansoprazole.|Exact (Clopper-Pearson)|0.7|||||TWO_SIDED|95.0|-4.901|6.319||||||||6.319|-4.901|
70990789|NCT03050359|141489787|OTHER||Difference in percentages|-4.1|||||TWO_SIDED|95.0|-15.579|7.344||||||Epigastric Pain (Postprandial)||7.344|-15.579|
70990790|NCT03050359|141489787|OTHER||Difference in percentages|1.6|||||TWO_SIDED|95.0|-5.23|8.422||||||Epigastric Pain (Fasting/Nocturnal)||8.422|-5.230|
70990791|NCT03050359|141489787|OTHER||Difference in percentages|-4.0|||||TWO_SIDED|95.0|-17.338|9.401||||||Abdominal Bloating||9.401|-17.338|
70990792|NCT03050359|141489787|OTHER||Difference in percentages|-9.3|||||TWO_SIDED|95.0|-26.334|7.815||||||Nausea/Vomiting||7.815|-26.334|
70990793|NCT03050359|141489787|OTHER||Difference in percentages|4.5|||||TWO_SIDED|95.0|-4.159|13.25||||||Heartburn||13.250|-4.159|
70990794|NCT03050359|141489787|OTHER||Difference in percentages|-9.1|||||TWO_SIDED|95.0|-21.104|2.922||||||Lack of Appetite||2.922|-21.104|
70990795|NCT02614287|141489789|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
70990796|NCT02614287|141489793|SUPERIORITY|||||||0.215|||||||Fisher Exact|||TE ADA Positive (TE ADA+)||||.215
70990797|NCT02614287|141489794|SUPERIORITY||LSMean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.46||0.6|TWO_SIDED|95.0|-1.76|0.04|||Mixed Models Analysis|||||0.04|-1.76|0.60
70990798|NCT02614287|141489795|SUPERIORITY||LSMean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.41||0.835|TWO_SIDED|95.0|-0.72|0.89|||Mixed Models Analysis|||||0.89|-0.72|.835
70990799|NCT02614287|141489796|SUPERIORITY||Odds Ratio (OR)|1.467||||0.063|TWO_SIDED|95.0|0.979|2.197|||CPLRM|CPLRM: Categorical pseudo likelihood-based repeated measures model||||2.197|0.979|.063
70990800|NCT02614287|141489797|SUPERIORITY||LSMean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.51||0.937|TWO_SIDED|95.0|-0.96|1.04|||Mixed Models Analysis|||||1.04|-0.96|.937
70990801|NCT02614287|141489798|SUPERIORITY||LSMean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.073|TWO_SIDED|95.0|-0.4|0.02|||Mixed Models Analysis|||||0.02|-0.40|0.073
70990802|NCT02614287|141489799|SUPERIORITY||LSMean Difference|0.91|STANDARD_ERROR_OF_MEAN|2.82||0.747|TWO_SIDED|95.0|-4.65|6.47|||Mixed Models Analysis|||||6.47|-4.65|.747
70990803|NCT02614287|141489800|SUPERIORITY||LSMean Difference|1.98|STANDARD_ERROR_OF_MEAN|1.55||0.203|TWO_SIDED|95.0|-1.07|5.03|||Mixed Models Analysis|||Total Score||5.03|-1.07|0.203
70990804|NCT02614287|141489800|SUPERIORITY||LSMean Difference|1.85|STANDARD_ERROR_OF_MEAN|1.59||0.247|TWO_SIDED|95.0|-1.29|4.98|||Mixed Models Analysis|||Role Function-Restrictive Domain Score||4.98|-1.29|.247
70990805|NCT02614287|141489800|SUPERIORITY||LSMean Difference|1.26|STANDARD_ERROR_OF_MEAN|1.49||0.399|TWO_SIDED|95.0|-1.67|4.19|||Mixed Models Analysis|||Role Function-Preventive Domain Score||4.19|-1.67|0.399
70990806|NCT02614287|141489800|SUPERIORITY||LSMean Difference|3.09|STANDARD_ERROR_OF_MEAN|1.8||0.88|TWO_SIDED|95.0|-0.46|6.64|||Mixed Models Analysis|||Emotional Function Domain Score||6.64|-0.46|0.88
70990807|NCT01156597|141489803|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|The percent change of HDL and triglycerides from baseline between groups was evaluated by ANOVA using baseline, 12 week and 24 week values||||||0.05
70990808|NCT03007485|141489826|SUPERIORITY||Odds Ratio (OR)|1.0|||<|0.05|TWO_SIDED|95.0||||Reported p-value was calculated|t-test, 2 sided|||Sample size and power calculation was a composite of COPD-related hospital readmissions or death within 6 months of discharge. First level of analysis was the ITT, which included all the patients randomly assigned to an arm at the beginning of the study (excluding those who were found to not meet inclusion criteria for referral). The second included all the patients medically cleared and third included all the patients who were medically cleared and who had participated in at least 1 PR session.|"The primary outcome was a composite of COPD-related hospital readmissions or death within 6 months of discharge (binary: yes/no). Logistic regression was used to compare the primary outcome in terms of the OR of event rates between the 2 arms, in 3 sets of models (per each of the 3 aforementioned level of analyses):~* Model 1: Treatment arm only with no other covariates added to the model~* Model 2: Treatment arm, adjusted for race and clinical site (stratification variables)~* Model 3: Treatment arm, adjusted for race, clinical site, and risk factors reported in the literature to be associated with the primary outcome, for explanatory purposes To examine the role of adherence on the primary outcome, we included adherence as a binary variable and as a continuous variable (percentage of sessions attended) in the 3 models."|||<.05
70990809|NCT01848054|141489831|NON_INFERIORITY_OR_EQUIVALENCE|The primary efficacy analysis of retention in treatment at Day 3 was assessed in the per protocol population. In addition, a sensitivity analysis assessed retention in treatment in the full analysis population. For these assessments, the margin to determine non-inferiority (i.e., lower limit of the 95% CI for the difference between BNX and generic buprenorphine of ≥-10%) was selected based on clinical experience to justify comparison between the 2 treatments.|||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|Comparisons between treatment groups were reported with 2-sided p values using 95% CIs for the difference.||||||<0.05
70990810|NCT01848054|141489838|NON_INFERIORITY_OR_EQUIVALENCE|The primary efficacy analysis of retention in treatment at Day 3 was assessed in the per protocol population. In addition, a sensitivity analysis assessed retention in treatment in the full analysis population. For these assessments, the margin to determine non-inferiority (i.e., lower limit of the 95% CI for the difference between BNX and generic buprenorphine of ≥-10%) was selected based on clinical experience to justify comparison between the 2 treatments.|||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|Comparisons between treatment groups were reported with 2-sided p values using 95% CIs for the difference.||||||<0.05
70990811|NCT01826422|141489848|SUPERIORITY||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.05
71039164|NCT00354835|141586101|SUPERIORITY_OR_OTHER_LEGACY||The incidence of febrile neutropenia|0.0881|||||ONE_SIDED|95.0||0.1216||||||Compare incidence of Febrile Neutropenia to historical rate of 0.50 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of febrile neutropenia will be calculated and evaluated to see if the interval contains the null rate of 0.50.||0.1216||
71039165|NCT00354835|141586101|SUPERIORITY_OR_OTHER_LEGACY||The incidence of platelet count decrease|0.3264|||||ONE_SIDED|95.0||0.3819||||||Compare incidence of Platelet Count Decreased to historical rate of 0.70 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of platelet count decreased will be calculated and evaluated to see if the interval contains the null rate of 0.70.||0.3819||
71039166|NCT00354835|141586101|SUPERIORITY_OR_OTHER_LEGACY||The incidence of vomiting|0.0104|||||ONE_SIDED|95.0||0.0224||||||Compare incidence of Vomiting to historical rate of 0.15 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of vomiting will be calculated and evaluated to see if the interval contains the null rate of 0.15.||0.0224||
71039167|NCT00354835|141586104|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99|TWO_SIDED|95.0|||||Fisher Exact|||The incidences of grade 3 or higher neutropenia, with or without fever between UGT1A1 Genotypes (6/6, 6/7, 7/7) were compared by the Fisher's exact test.||||0.99
71039168|NCT00354835|141586104|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036|TWO_SIDED|95.0|||||Fisher Exact|||The incidences of grade 3 or higher diarrhea between UGT1A1 Genotypes (6/6, 6/7, 7/7) were compared by Fisher's exact test.||||0.036
71039169|NCT01968551|141586109|NON_INFERIORITY_OR_EQUIVALENCE|Null Hypothesis: In Cohort 2, the group switching to E/C/F/TAF + DRV was at least 12% lower than the group remaining on SBR with respect to percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24. Alternative Hypothesis: In Cohort 2, the group switching to E/C/F/TAF + DRV is less than 12% lower than the group remaining on SBR with respect to the proportion of participants with HIV-1 RNA\<50 copies/mL at Week 24.|Difference in proportion|5.3||||0.23|TWO_SIDED|95.001|-3.4|17.4|||Fisher Exact||Difference in percentages of virologic success and its 95.001% confidence interval (CI) calculation was based on exact method. The exact CI was estimated based on unconditional exact method using 2 inverted 1-sided tests with standardized statistic.|||17.4|-3.4|0.23
71098686|NCT01654250|141705825|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.56||0.097|TWO_SIDED|95.0|-2.0|0.2|||Mixed Models Analysis|||Hour 10 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||0.2|-2.0|0.097
71098687|NCT01654250|141705825|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.56||0.49|TWO_SIDED|95.0|-1.5|0.7|||Mixed Models Analysis|||Hour 12 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||0.7|-1.5|0.490
70990812|NCT01826422|141489849|SUPERIORITY_OR_OTHER||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||>0.05
70990813|NCT01826422|141489850|SUPERIORITY_OR_OTHER||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||>0.05
70990814|NCT01826422|141489851|SUPERIORITY_OR_OTHER||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.05
70990815|NCT01826422|141489852|SUPERIORITY||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.05
70990816|NCT01826422|141489853|SUPERIORITY_OR_OTHER||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||>0.05
70990817|NCT01826422|141489854|SUPERIORITY||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||<0.05
70990818|NCT01826422|141489855|SUPERIORITY_OR_OTHER||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||<0.05
70990819|NCT01826422|141489856|SUPERIORITY||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||<0.05
70990820|NCT01826422|141489857|SUPERIORITY||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|t-test, 1 sided|||||||<0.05
70990821|NCT01826422|141489858|SUPERIORITY||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|t-test, 1 sided|||||||<0.05
70990822|NCT01826422|141489859|SUPERIORITY|||||||0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|t-test, 1 sided|||||||0.05
70990823|NCT01826422|141489860|SUPERIORITY||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||>0.05
70990824|NCT01826422|141489861|SUPERIORITY||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||>0.05
70990825|NCT01826422|141489862|SUPERIORITY||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||>0.05
70990826|NCT01826422|141489863|SUPERIORITY_OR_OTHER||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||>0.05
70990827|NCT01826422|141489864|SUPERIORITY||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||>0.05
70990828|NCT01826422|141489865|SUPERIORITY|||||||0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||0.05
70990829|NCT01826422|141489866|SUPERIORITY|||||||0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||0.05
70990830|NCT01826422|141489867|SUPERIORITY|||||||0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||0.05
70990831|NCT00115349|141489878|SUPERIORITY_OR_OTHER|||||||0.89||0.0|||||Mixed Models Analysis|Linear mixed models with treatment, time, and treatment x time interaction were used, allowing for random participant-specific intercepts and slopes.||The intended sample size of 86 patients (N=43 per arm) had 80% power to detect a 5% difference in LVEF between the two arms after 1 year of treatment, assuming a standard deviation of change in LVEF of 7.46%, and 20% loss to follow-up. The study was stopped early by NHLBI when analysis of the interim data confirmed a required sample size of 86 that was not achievable within the required time frame within the participating or planned centres.||||0.89
70990832|NCT02902172|141489949|NON_INFERIORITY||Mean Difference (Net)|0.85|||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
70990833|NCT02336594|141489962|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the Pharmacokinetics (PK), Pharmacodynamics (PD), and safety profile of RDEA3170.|Geometric Least Squares Mean Ratio (%)|107.0|||||TWO_SIDED|90.0|95.2|120.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||120|95.2|
70990834|NCT02336594|141489964|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|97.3|||||TWO_SIDED|90.0|85.6|111.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||111|85.6|
70990835|NCT02336594|141489965|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|100.0|||||TWO_SIDED|90.0|87.3|115.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||115|87.3|
70990836|NCT02336594|141489967|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|182.0|||||TWO_SIDED|90.0|144.0|230.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||230|144|
71098688|NCT01654250|141705825|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.56||0.164|TWO_SIDED|95.0|-1.9|0.3|||Mixed Models Analysis|||Hour 13 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||0.3|-1.9|0.164
70990837|NCT02336594|141489968|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|140.0|||||TWO_SIDED|90.0|121.0|163.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||163|121|
70990838|NCT02336594|141489969|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|134.0|||||TWO_SIDED|90.0|114.0|156.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||156|114|
70990839|NCT02336594|141489970|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|79.1|||||TWO_SIDED|90.0|66.4|94.2|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||94.2|66.4|
70990840|NCT02336594|141489971|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|85.5|||||TWO_SIDED|90.0|73.9|98.8|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||98.8|73.9|
70990841|NCT02336594|141489972|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|83.4|||||TWO_SIDED|90.0|73.5|94.7|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||94.7|73.5|
70990842|NCT04891770|141489984|OTHER||percentage difference|2.5|||||TWO_SIDED|95.0|-2.3|7.3|||||For Cohort 2A versus Cohort 2B, the percentage difference and the corresponding 95% confidence interval was calculated using the stratum-adjusted Mantel-Haenszel method, stratified by HBsAg group (\> 3 and ≤ 3 log10 IU/mL).|||7.3|-2.3|
70990843|NCT04026412|141489989|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.646|TWO_SIDED|96.0|0.77|1.19|||Cox proportional hazards model|||||1.19|0.77|0.6460
70990844|NCT04026412|141489990|SUPERIORITY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.87|1.41||||||||1.41|0.87|
70990845|NCT04026412|141489990|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.75|1.22||||||||1.22|0.75|
70990846|NCT04026412|141489990|SUPERIORITY||Hazard Ratio, log|1.16|||||TWO_SIDED|95.0|0.91|1.48||||||||1.48|0.91|
70990847|NCT04026412|141489991|SUPERIORITY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.69|1.05||||||||1.05|0.69|
70990848|NCT04026412|141489991|SUPERIORITY||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.93|1.42||||||||1.42|0.93|
71039170|NCT01968551|141586110|NON_INFERIORITY_OR_EQUIVALENCE|Null Hypothesis: In Cohort 2, the group switching to E/C/F/TAF + DRV was at least 12% lower than the group remaining on SBR with respect to percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48. Alternative Hypothesis: In Cohort 2, the group switching to E/C/F/TAF + DRV is less than 12% lower than the group remaining on SBR with respect to the proportion of participants with HIV-1 RNA \< 50 copies/mL at Week 48.|Difference in proportion|18.3||||0.004|TWO_SIDED|95.001|3.5|33.0|||Fisher Exact||Difference in percentages of virologic success and its 95.001% CI were calculated based on exact method. The exact CI was estimated based on unconditional exact method using 2 inverted 1-sided tests with the standardized statistic.|||33.0|3.5|0.004
71039171|NCT00431041|141586113|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
71039172|NCT00431041|141586114|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value represents overall comparison of severity of dry mouth.|Chi-squared|||||||0.0010
71039173|NCT00573313|141586118|SUPERIORITY_OR_OTHER||Ratio of Geometric Means at 24 weeks.|0.1505|STANDARD_ERROR_OF_MEAN|0.1615||0.36|TWO_SIDED|95.0|-0.1853|0.4863||The data provided here are for changes in serum AST levels as representative of all clinical laboratory parameters measured.|ANCOVA|Analysis of covariance controlled for baseline data, e.g. AST.|Obtained median values and ranges and log transformations of SD.|Power calculation indicated that a sample size of 20 subjects per treatment arm would detect differences between groups of 0.9 within-subject standard deviations or higher at 80% power and 5% level of significance.||0.4863|-0.1853|0.36
71039174|NCT01597791|141586128|SUPERIORITY|||||||0.05||||||Calculated.|Fisher Exact|||||||.05
71039175|NCT03405363|141586129|OTHER|No formal hypotheses were tested.|Adjusted Incidence Rate Ratio|1.2|||||TWO_SIDED|95.0|0.98|1.47|||Poisson regression model|Including exposure, natural logarithm of person-years at risk as offset, propensity score quintiles, and LAMA use at the index date as a covariate.|Olodaterol compared to 'other LABA' as reference|||1.47|0.98|
71039176|NCT03405363|141586130|OTHER||Adjusted Incidence Rate Ratio|1.83|||||TWO_SIDED|95.0|0.9|3.74|||Poisson regression model|Including exposure, natural logarithm of person-years at risk as offset, propensity score quintiles, and LAMA use at the index date as a covariate.|Olodaterol compared to 'other LABA' as reference|No formal hypotheses were tested.||3.74|0.90|
70990849|NCT04026412|141489992|SUPERIORITY||Difference in ORR|3.2|||||TWO_SIDED|95.0|-4.1|10.6||||||||10.6|-4.1|
70990850|NCT04026412|141489992|SUPERIORITY||Difference in ORR|7.8|||||TWO_SIDED|95.0|0.7|14.8||||||||14.8|0.7|
70990851|NCT04026412|141489992|SUPERIORITY||Difference in ORR|-4.7|||||TWO_SIDED|95.0|-11.8|2.5||||||||2.5|-11.8|
70990852|NCT04026412|141489995|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.82|1.23||||||||1.23|0.82|
70990853|NCT04026412|141489995|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.7|1.05||||||||1.05|0.70|
70990854|NCT04026412|141489995|SUPERIORITY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.95|1.44||||||||1.44|0.95|
70990855|NCT04026412|141489996|SUPERIORITY||Difference in ORR|3.5|||||TWO_SIDED|95.0|-4.1|11.1||||||||11.1|-4.1|
70990856|NCT04026412|141489996|SUPERIORITY||Difference in ORR|5.4|||||TWO_SIDED|95.0|-2.0|12.9||||||||12.9|-2.0|
70990857|NCT04026412|141489996|SUPERIORITY||Difference in ORR|-1.9|||||TWO_SIDED|95.0|-9.5|5.6||||||||5.6|-9.5|
70990858|NCT04026412|141489999|SUPERIORITY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.76|1.23||||||||1.23|0.76|
70990859|NCT04026412|141489999|SUPERIORITY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.65|1.06||||||||1.06|0.65|
70990860|NCT04026412|141489999|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.91|1.49||||||||1.49|0.91|
71039177|NCT03405363|141586131|OTHER||Adjusted Incidence Rate Ratio|1.3|||||TWO_SIDED|95.0|0.71|2.36|||Poisson regression model|Including exposure, natural logarithm of person-years at risk as offset, propensity score quintiles, and LAMA use at the index date as a covariate.|Olodaterol compared to 'other LABA' as reference|No formal hypotheses were tested.||2.36|0.71|
71039178|NCT03405363|141586132|OTHER||Adjusted Incidence Rate Ratio|1.22|||||TWO_SIDED|95.0|0.79|1.87|||Poisson regression model|Including exposure, natural logarithm of person-years at risk as offset, propensity score quintiles, and LAMA use at the index date as a covariate.|Olodaterol compared to 'other LABA' as reference|No formal hypotheses were tested.||1.87|0.79|
71039179|NCT03405363|141586133|OTHER||Adjusted Incidence Rate Ratio|1.0|||||TWO_SIDED|95.0|0.64|1.56|||Poisson regression model|Including exposure, natural logarithm of person-years at risk as offset, propensity score quintiles, and LAMA use at the index date as a covariate.|Olodaterol compared to 'other LABA' as reference|No formal hypotheses were tested.||1.56|0.64|
70990861|NCT00904826|141490002|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between before treatment and one year after treatment.||||<0.0001
70990862|NCT00904826|141490004|SUPERIORITY_OR_OTHER|||||||0.0078||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison was made between baseline and after 12 months of treatment.||||0.0078
70990863|NCT00904826|141490008|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison is between 6 weeks and baseline.||||<0.0001
70990864|NCT00904826|141490008|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison is between 3 months and baseline.||||<0.0001
70990865|NCT00904826|141490008|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison is between 6 months and baseline||||0.0001
70990866|NCT00904826|141490008|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison is between 9 months and baseline.||||0.0001
70990867|NCT00904826|141490008|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison is between 12 months and baseline.||||<0.0001
70990868|NCT00904826|141490010|SUPERIORITY_OR_OTHER|||||||0.0019||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison was between 3 months and baseline.||||0.0019
70990869|NCT01125176|141490031|OTHER|Exact Clopper-Pearson 95% confidence interval for overall response rate.|Proportion (percent)|85.7|||||TWO_SIDED|95.0|73.5|100.0||||||||100.0|73.5|
70990870|NCT04360187|141490037|SUPERIORITY||LS mean of difference|-17.13||||0.0002|TWO_SIDED|95.0|-25.98|-8.27|||Mixed effect Model for Repeated Measures||Crisaborole = Test Vehicle = Reference|||-8.27|-25.98|0.0002
70990871|NCT04360187|141490041|SUPERIORITY||Risk Difference (RD)|12.9||||0.0124|TWO_SIDED|95.0|2.8|23.1|||normal approximation to response rates||Crisaborole = Test Vehicle = Reference|||23.1|2.8|0.0124
70990872|NCT04360187|141490042|SUPERIORITY||Risk Difference (RD)|11.7||||0.0078|TWO_SIDED|95.0|3.1|20.3|||normal approximation to response rates||Crisaborole = Test Vehicle = Reference|||20.3|3.1|0.0078
70990873|NCT04360187|141490043|SUPERIORITY||LS Mean of Difference|-0.79||||0.0009|TWO_SIDED|95.0|-1.26|-0.33|||Mixed effect Model for Repeated Measures||Crisaborole = Test Vehicle = Reference|||-0.33|-1.26|0.0009
70990874|NCT01318083|141490073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.936|||||TWO_SIDED|95.0|-1.097|-0.775||||||||-0.775|-1.097|
70990875|NCT01318083|141490073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.998|||||TWO_SIDED|95.0|-1.16|-0.837||||||||-0.837|-1.160|
70990876|NCT01318083|141490074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.196|||||TWO_SIDED|95.0|-0.261|-0.131||||||||-0.131|-0.261|
70990877|NCT01318083|141490074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.213|||||TWO_SIDED|95.0|-0.273|-0.154||||||||-0.154|-0.273|
70990878|NCT01318083|141490075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|||||TWO_SIDED|95.0|-0.507|-0.312||||||||-0.312|-0.507|
70990879|NCT01318083|141490075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.453|||||TWO_SIDED|95.0|-0.547|-0.358||||||||-0.358|-0.547|
70990880|NCT01318083|141490076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.695|||||TWO_SIDED|95.0|-0.834|-0.556||||||||-0.556|-0.834|
70990881|NCT01318083|141490076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|||||TWO_SIDED|95.0|-0.911|-0.629||||||||-0.629|-0.911|
70990882|NCT01318083|141490077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.71|||||TWO_SIDED|95.0|-24.6|-10.83||||||||-10.83|-24.60|
70990883|NCT01318083|141490077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.59|||||TWO_SIDED|95.0|-24.93|-10.25||||||||-10.25|-24.93|
70990884|NCT01318083|141490078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.17|||||TWO_SIDED|95.0|-30.33|-16.02||||||||-16.02|-30.33|
70990885|NCT01318083|141490078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.88|||||TWO_SIDED|95.0|-32.33|-17.43||||||||-17.43|-32.33|
70990886|NCT01318083|141490079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.62|||||TWO_SIDED|95.0|-35.32|-19.91||||||||-19.91|-35.32|
70990887|NCT01318083|141490079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.72|||||TWO_SIDED|95.0|-30.76|-14.69||||||||-14.69|-30.76|
70990888|NCT01318083|141490080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.37|||||TWO_SIDED|95.0|-37.14|-19.59||||||||-19.59|-37.14|
70990889|NCT01318083|141490080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.93|||||TWO_SIDED|95.0|-30.33|-13.54||||||||-13.54|-30.33|
70990890|NCT01318083|141490081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.41|||||TWO_SIDED|95.0|-36.58|-10.23||||||||-10.23|-36.58|
70990891|NCT01318083|141490081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.18|||||TWO_SIDED|95.0|-33.4|-4.95||||||||-4.95|-33.40|
70990892|NCT00256867|141490082|SUPERIORITY_OR_OTHER||Ratio Expressed as percent difference|-37.186|||<|0.0001|TWO_SIDED|95.0|-41.219|-32.879|||ANCOVA||Estimation parameter was Ratio to RSG Group expressed as percent difference from RSG group. Based on ANCOVA : Log(value) - log(baseline)= log(baseline) + sex + country + Treatment + Prior Sulfonylurea use|||-32.879|-41.219|<0.0001
70990893|NCT00256867|141490083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|||<|0.0001|TWO_SIDED|95.0|-1.09|-0.55|||ANCOVA||Change = Baseline + sex + country + Treatment + Prior Sulfonylurea use|||-0.55|-1.09|<0.0001
70990894|NCT00256867|141490087|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|36.32|||<|0.0001||95.0|16.52|79.85|||ANCOVA||Odds (logistic regression:log odds=Baseline + sex + Treatment + Prior Sulfonylurea use) of having an LDL-c \< 100 mg/dL at Week 6 on All FDC RSG/SIMV groups compared to All RSG monotherapy groups|||79.85|16.52|<.0001
70990895|NCT00256867|141490088|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.05|||<|0.0001|TWO_SIDED|95.0|2.32|7.07|||ANCOVA||Odds (logistic regression: log odds=Baseline + sex + Treatment + Prior SU use) of having an HbA1c \< 7% or reduction of HbA1c \>= 0.7% at Week 16 on All FDC group compared to Simv group.|||7.07|2.32|<0.0001
70990896|NCT00256867|141490089|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.93|||<|0.0001|TWO_SIDED|95.0|2.21|7.0|||ANCOVA||Odds (logistic regression:log odds=Baseline + sex + Treatment + Prior SU use) of having an FPG \< 7.0 mmol/L or reduction of FPG \>= 1.67 mmol/L at Week 16 on All FDC group compared to Simv group.|||7|2.21|<0.0001
70990897|NCT02993224|141490095|SUPERIORITY||Difference of proportion|0.83|||<|0.0001|TWO_SIDED|95.0|0.75|0.89|||McNemar|||Preference for deferasirox DT vs deferasirox FCT||0.89|0.75|<.0001
70990898|NCT02993224|141490096|SUPERIORITY||Difference of proportion|0.78|||<|0.0001|TWO_SIDED|95.0|0.65|0.88|||McNemar|||Preference of deferasirox FCT vs deferasirox DT||0.88|0.65|<0.0001
70990899|NCT02993224|141490096|SUPERIORITY||Difference of proportion|0.83|||<|0.0001|TWO_SIDED|95.0|0.71|0.91|||McNemar|||Preference for deferasirox FCT vs previous iron chelation therapy||0.91|0.71|<0.0001
70990900|NCT02993224|141490097|SUPERIORITY||Difference of proportion|0.66|||<|0.0001|TWO_SIDED|95.0|0.51|0.77|||McNemar|||Deferasirox DT vs previous iron chelation therapy at Week 4||0.77|0.51|< 0.0001
70990901|NCT02993224|141490097|SUPERIORITY||Difference of proportion|0.59|||<|0.0001|TWO_SIDED|95.0|0.44|0.72|||McNemar|||Deferasirox DT vs previous iron chelation therapy at Week 24||0.72|0.44|< 0.0001
70990902|NCT02993224|141490099|SUPERIORITY||Least squares mean|-3.6|STANDARD_ERROR_OF_MEAN|2.3||0.1191|TWO_SIDED|95.0|-8.1|0.9|||ANCOVA|||Compliance of deferasirox DT vs deferasirox FCT||0.9|-8.1|0.1191
70990903|NCT02915367|141490117|OTHER|Pearson chi-square||||||0.93|||||||Chi-squared|||||||0.93
70990904|NCT02915367|141490119|OTHER|Pearson chi-square||||||0.96|||||||Chi-squared|||||||0.96
70990905|NCT00952289|141490127|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||The primary endpoint analyzed with a 2-sided alpha of 0.05.||||<0.0001
70990906|NCT02932475|141490138|SUPERIORITY||Odds Ratio (OR)|0.86|||||TWO_SIDED|95.0|0.63|1.19|||||The odds ratio was calculated and adjusted for study site, timing of diabetes diagnosis, gestational age at randomization stratified at 18 weeks, and baseline maternal BMI.|The sample size gave adequate power over a range of expected primary outcome event rates, with type I error set at 0.044 (reduced from 0.05 for interim analysis), with reasonable power under a conservative scenario assuming that 20% of subjects immediately stopped taking study agent.||1.19|0.63|
70990907|NCT02932475|141490139|SUPERIORITY||Difference in proportions|0.2||||0.4|TWO_SIDED|||||The a priori threshold for statistical significance was \<0.05.|Chi-squared|||||||0.4
70990908|NCT02932475|141490140|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.4|TWO_SIDED|||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided||comparison of mean (sd) between groups|||||0.4
70990909|NCT02932475|141490141|SUPERIORITY||Difference in proportions|0.0||||0.6|TWO_SIDED|||||The a priori threshold for statistical significance is \<0.05.|Chi-squared|||||||0.6
70990910|NCT02932475|141490142|SUPERIORITY||Difference in proportions|0.0||||0.08|TWO_SIDED|||||The a priori threshold for statistical significance is \<0.05.|Chi-squared|||||||0.08
70990911|NCT02322320|141490143|SUPERIORITY|||||||0.6||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and RVD consolidation therapy.||||0.60
70990912|NCT02322320|141490143|SUPERIORITY|||||||0.35||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and Lenalidomide maintenance therapy.||||0.35
70990913|NCT02322320|141490143|SUPERIORITY|||||||0.68||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to RVD consolidation and Lenalidomide maintenance therapy.||||0.68
70990914|NCT02322320|141490144|SUPERIORITY|||||||0.57||||||The analysis involved pairwise comparisons of OS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with OS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and RVD consolidation therapy.||||0.57
70990915|NCT02322320|141490144|SUPERIORITY|||||||0.38||||||The analysis involved pairwise comparisons of OS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with OS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and Lenalidomide maintenance therapy.||||0.38
70990916|NCT02322320|141490144|SUPERIORITY|||||||0.77||||||The analysis involved pairwise comparisons of OS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with OS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to RVD consolidation and Lenalidomide maintenance therapy.||||0.77
70923018|NCT00567398|141337092|SUPERIORITY||Mean Difference (Final Values)|6.3||||0.626|TWO_SIDED|95.0|-19.3|31.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Diastolic Volume-Month 6||31.9|-19.3|0.626
70990917|NCT02322320|141490145|SUPERIORITY|||||||0.67||||||The analysis involved pairwise comparisons of EFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with EFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and RVD consolidation therapy.||||0.67
70990918|NCT02322320|141490145|SUPERIORITY|||||||0.2||||||The analysis involved pairwise comparisons of EFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with EFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and Lenalidomide maintenance therapy.||||0.20
70990919|NCT02322320|141490145|SUPERIORITY|||||||0.4||||||The analysis involved pairwise comparisons of EFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with EFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to RVD consolidation and Lenalidomide maintenance therapy.||||0.40
70990920|NCT02322320|141490146|SUPERIORITY|||||||0.43||||||The analysis involved pairwise comparisons of SPM between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Gray's test|Gray's test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with SPM at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and RVD consolidation therapy.||||0.43
71039180|NCT03405363|141586134|OTHER|No formal hypotheses were tested.|Adjusted Incidence Rate Ratio|1.63|||||TWO_SIDED|95.0|1.44|1.84|||Poisson regression model|Including exposure, natural logarithm of person-years at risk as offset, propensity score quintiles, and LAMA use at the index date as a covariate.|Olodaterol compared to 'other LABA' as reference|Analysis was based on Propensity score-trimmed population of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from the Danish Patient Registry.||1.84|1.44|
70923019|NCT00567398|141337092|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.486|TWO_SIDED|95.0|-14.5|30.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Systolic Volume-Month 6||30.1|-14.5|0.486
70923020|NCT00567398|141337093|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.832|TWO_SIDED|95.0|-18.9|23.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass with Pap Muscles-Month 6||23.4|-18.9|0.832
70923021|NCT00567398|141337093|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.82|TWO_SIDED|95.0|-18.3|23.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass without Pap Muscles-Month 6||23.1|-18.3|0.820
70923022|NCT00567398|141337094|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.955|TWO_SIDED|95.0|-6.9|6.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Ejection Fraction-Month 6||6.5|-6.9|0.955
70923023|NCT03830177|141337100|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
70923024|NCT03830177|141337101|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
70923025|NCT03830177|141337102|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
70923026|NCT03830177|141337103|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
70923027|NCT03830177|141337105|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
70923028|NCT03137771|141337107|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.66|TWO_SIDED|95.0|0.68|1.4|||Log Rank|Two-sided test|Reference level = systemic therapy. Cox proportional hazards model stratified by histology (non-squamous vs squamous) and systemic therapy (immunotherapy-based regimens vs chemotherapy- only regimens).|Based on expected 6- and 12-month PFS rates of approximately 60% and 39% for the standard arm, assuming approximately exponential distributions, at least 138 PFS events are needed to detect a hazard ratio of 0.6 (a hazard reduction of 40%) with 95% power and a one-sided significance level of 0.15. The Cox proportional hazards model is stratified by histology and systemic therapy type. The hazard ratio estimate must be ≤ 0.83 for the study to proceed to the phase III component.||1.40|0.68|0.66
70923029|NCT03289039|141337126|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.98|TWO_SIDED|95.0|0.27|4.12|||Log Rank|||||4.12|0.27|0.98
70923030|NCT03289039|141337127|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.89|TWO_SIDED|95.0|0.24|2.81|||Log Rank|||||2.81|0.24|0.89
70923031|NCT04732494|141337142|SUPERIORITY|The primary endpoint ORR was tested at a 2-sided alpha of 0.05.|Risk Difference (RD)|9.9||||0.2114|TWO_SIDED|95.0|-5.4|25.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel method stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|||25.3|-5.4|0.2114
70923032|NCT04732494|141337143|OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.58|1.45|||||Hazard ratio and 95% confidence intervals (CIs) were estimated using a Cox regression model stratified by the selected stratification factors (ECOG PS score \[0 vs 1\] and the number of organs with metastases \[≤ 1 vs ≥ 2\]).|||1.45|0.58|
70923033|NCT04732494|141337144|OTHER||Risk Difference (RD)|6.6|||||TWO_SIDED|95.0|-9.2|22.5|||||Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|||22.5|-9.2|
70923034|NCT04732494|141337145|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.64|1.59|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by the selected stratification factors (ECOG PS score \[0 vs 1\] and the number of organs with metastases \[≤ 1 vs ≥ 2\]).|||1.59|0.64|
70923035|NCT04732494|141337146|OTHER||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.71|1.61|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by the selected stratification factors (ECOG PS score \[0 vs 1\] and the number of organs with metastases \[≤ 1 vs ≥ 2\]).|||1.61|0.71|
70923036|NCT04732494|141337149|OTHER||Risk Difference (RD)|2.7|||||TWO_SIDED|95.0|-14.4|19.9|||||Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|Analysis of Disease Control Rate Assessed by the Investigator||19.9|-14.4|
70923037|NCT04732494|141337149|OTHER||Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|-11.7|21.8|||||Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|Analysis of Disease Control Rate Assessed by the Independent Review Committee||21.8|-11.7|
70923038|NCT04732494|141337150|OTHER||Risk Difference (RD)|3.9|||||TWO_SIDED|95.0|-12.7|20.4|||||Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|Analysis of Clinical Benefit Rate Assessed by the Investigator||20.4|-12.7|
70923039|NCT04732494|141337150|OTHER||Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|-11.0|21.0|||||Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|Analysis of Clinical Benefit Rate Assessed by the Independent Review Committee||21.0|-11.0|
70923040|NCT04732494|141337151|OTHER||Least Squares (LS) Mean Difference|1.8|||||TWO_SIDED|95.0|-8.4|11.9||||||Analysis of Change from Baseline in Global Health Status/QoL at Cycle 5. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||11.9|-8.4|
70923041|NCT04732494|141337151|OTHER||LS Mean Difference|3.1|||||TWO_SIDED|95.0|-5.0|11.2||||||Analysis of Change from Baseline in Global Health Status/QoL at Cycle 7. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||11.2|-5.0|
70923042|NCT04732494|141337151|SUPERIORITY||LS Mean Difference|-1.7|||||TWO_SIDED|95.0|-7.1|3.7||||||Analysis of Change from Baseline in Physical Functioning at Cycle 5. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||3.7|-7.1|
70990921|NCT02322320|141490146|SUPERIORITY|||||||0.7||||||The analysis involved pairwise comparisons of SPM between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Gray's test|Gray's test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with SPM at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and Lenalidomide maintenance therapy.||||0.70
70923043|NCT04732494|141337151|OTHER||LS Mean Difference|-0.5|||||TWO_SIDED|95.0|-10.3|9.3||||||Analysis of Change from Baseline in Physical Functioning at Cycle 7. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||9.3|-10.3|
70923044|NCT04732494|141337152|OTHER||LS Mean Difference|-9.9|||||TWO_SIDED|95.0|-21.5|1.6||||||Analysis of Change from Baseline in Dysphagia at Cycle 5. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||1.6|-21.5|
70923045|NCT04732494|141337152|OTHER||LS Mean Difference|-10.8|||||TWO_SIDED|95.0|-27.8|6.3||||||Analysis of Change from Baseline in Dysphagia at Cycle 7. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||6.3|-27.8|
70923046|NCT04732494|141337152|OTHER||LS Mean Difference|-0.4|||||TWO_SIDED|95.0|-7.3|6.6||||||Analysis of Change from Baseline in Eating at Cycle 5. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||6.6|-7.3|
70923047|NCT04732494|141337152|OTHER||LS Mean Difference|-9.4|||||TWO_SIDED|95.0|-18.5|-0.3||||||Analysis of Change from Baseline in Eating at Cycle 7. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||-0.3|-18.5|
70923048|NCT04732494|141337152|OTHER||LS Mean Difference|2.3|||||TWO_SIDED|95.0|-6.7|11.2||||||Analysis of Change from Baseline in Reflux at Cycle 5. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||11.2|-6.7|
70923049|NCT04732494|141337152|OTHER||LS Mean Difference|-1.4|||||TWO_SIDED|95.0|-11.8|9.0||||||Analysis of Change from Baseline in Reflux at Cycle 7. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||9.0|-11.8|
70923050|NCT04732494|141337152|OTHER||LS Mean Difference|0.7|||||TWO_SIDED|95.0|-7.0|8.5||||||Analysis of Change from Baseline in Pain at Cycle 5. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||8.5|-7.0|
70923051|NCT04732494|141337152|OTHER||LS Mean Difference|-5.3|||||TWO_SIDED|95.0|-12.3|1.7||||||Analysis of Change from Baseline in Pain at Cycle 7. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||1.7|-12.3|
70923052|NCT03897686|141337154|SUPERIORITY|\[Not specified\]|LS-means difference|-179.3|STANDARD_ERROR_OF_MEAN|48.38||0.0003|TWO_SIDED|95.0|-274.96|-83.65||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||"It was determined that 144 participants randomized into 2 groups (1:1) would have at least 80% power to detect an effect size of 0.25. Sample size was calculated based on analysis of covariance adjusted for baseline value with fixed factors of group assuming α = 0.05 and 10% discontinuation rate.~The null hypothesis states that there is no difference between treatment groups in mean change from baseline to Week 25 in the total WOMAC score."||-83.65|-274.96|0.00030
70923053|NCT03897686|141337154|SUPERIORITY|\[Not specified\]|LS-means difference|-179.3|STANDARD_ERROR_OF_MEAN|48.38||0.0017|TWO_SIDED|95.0|-305.11|-53.5||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test|Tukey's HSD|||"After the analysis of covariance were performed pairwise comparisons of NOLTREX and placebo groups for each stage of OA:~1\) Group A (NOLTREX™) OA grade II versus Group B (Placebo) ОА grade II"||-53.50|-305.11|0.0017
70923054|NCT03897686|141337154|SUPERIORITY||LS-means difference|-37.01|STANDARD_ERROR_OF_MEAN|61.85||0.9324|TWO_SIDED|95.0|-197.83|123.82||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test|Tukey's HSD|||"After the analysis of covariance were performed pairwise comparisons of NOLTREX and placebo groups for each stage of OA:~2\) Group A (NOLTREX™) OA grade II versus Group A (NOLTREX™) ОА grade III"||123.82|-197.83|0.9324
70923055|NCT03897686|141337154|SUPERIORITY||LS-means difference|-216.31|STANDARD_ERROR_OF_MEAN|75.01||0.0233|TWO_SIDED|95.0|-411.37|-21.25||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||"After the analysis of covariance were performed pairwise comparisons of NOLTREX and placebo groups for each stage of OA:~3\) Group A (NOLTREX™) OA grade II versus Group B (Placebo) ОА grade III"||-21.25|-411.37|0.0233
71098689|NCT01654250|141705825|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|0.94||0.004|TWO_SIDED|95.0|-4.6|-0.9|||Mixed Models Analysis|||Hour 0.75 post-dose deportment subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-0.9|-4.6|0.004
71098690|NCT01654250|141705825|SUPERIORITY_OR_OTHER||LS Mean difference|-3.9|STANDARD_ERROR_OF_MEAN|0.94|<|0.001|TWO_SIDED|95.0|-5.8|-2.1|||Mixed Models Analysis|||Hour 2 post-dose deportment subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-2.1|-5.8|<0.001
71098691|NCT01654250|141705825|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|0.94|<|0.001|TWO_SIDED|95.0|-5.8|-2.1|||Mixed Models Analysis|||Hour 4 post-dose deportment sub scale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-2.1|-5.8|<0.001
70923056|NCT03897686|141337154|SUPERIORITY||LS-means difference|142.3|STANDARD_ERROR_OF_MEAN|81.89||0.3082|TWO_SIDED|95.0|-70.63|355.22||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||"After the analysis of covariance were performed pairwise comparisons of NOLTREX and placebo groups for each stage of OA:~4\) Group A (NOLTREX™) OA grade III versus Group B (Placebo) ОА grade II"||355.22|-70.63|0.3082
70923057|NCT03897686|141337154|SUPERIORITY||LS-means difference|-37.01|STANDARD_ERROR_OF_MEAN|61.85||0.9324|TWO_SIDED|95.0|-197.83|123.82||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||"After the analysis of covariance were performed pairwise comparisons of NOLTREX and placebo groups for each stage of OA:~5\) versus Group B (Placebo) OA grade II versus Group B (Placebo) ОА grade III"||123.82|-197.83|0.9324
70923058|NCT03897686|141337154|SUPERIORITY||Slope|-179.3|STANDARD_ERROR_OF_MEAN|48.38||0.0017|TWO_SIDED|95.0|-305.11|-53.5||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||"After the analysis of covariance were performed pairwise comparisons of NOLTREX and placebo groups for each stage of OA:~6\) Group A (NOLTREX™) OA grade III versus Group B (Placebo) ОА grade III"||-53.50|-305.11|0.0017
70990922|NCT02322320|141490146|SUPERIORITY|||||||0.7||||||The analysis involved pairwise comparisons of SPM between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Gray's test|Gray's test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with SPM at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to RVD consolidation and Lenalidomide maintenance therapy.||||0.70
70990923|NCT02876055|141490163|SUPERIORITY|||||||0.542|||||||Wilcoxon (Mann-Whitney)|||||||0.542
70990924|NCT02876055|141490163|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70990925|NCT02876055|141490163|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
70990926|NCT03453151|141490181|OTHER|||||||0.053|||||||Paired t-test|||||||0.053
70990927|NCT03453151|141490182|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
70990928|NCT03453151|141490183|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
70990929|NCT03453151|141490184|OTHER|||||||0.077|||||||Paired t-test|This analysis refers to the resting cardiac index.||||||0.077
70990930|NCT03453151|141490184|OTHER|||||||0.069|||||||Paired t-test|This analysis refers to the peak exercise cardiac index.||||||0.069
70990931|NCT03453151|141490186|OTHER|||||||0.25|||||||Paired t-test|This analysis refers to creatinine level.||||||0.250
70990932|NCT03453151|141490186|OTHER|||||||0.014|||||||Paired t-test|This analysis refers to BUN level.||||||0.014
70990933|NCT00958308|141490187|SUPERIORITY_OR_OTHER||||||=|0.02|||||||Fisher Exact|||The sample size calculation was based on the incidence of AAD. A total of 255 patients was enrolled in order to obtain at least the required 225 evaluable patients.With expected AAD rates of at most 15% - 25% in the treatment groups; and 25% - 35% in the placebo group, these numbers were sufficient to detect the difference in the incidence of AAD between either of the treatment groups vs. placebo with a minimum of 86% statistical power.||||=0.02
70990934|NCT02065622|141490192|SUPERIORITY||Adjusted risk difference|2.5||||0.269|TWO_SIDED|95.0|-2.0|7.0|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||7.0|-2.0|0.269
70990935|NCT02065622|141490192|SUPERIORITY|||||||0.447|||||||Breslow-Day test|Breslow-Day test of homogeneity across strata.||||||0.447
70990936|NCT02065622|141490192|SUPERIORITY||Adjusted risk difference|2.3||||0.301|TWO_SIDED|95.0|-2.0|6.6|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||6.6|-2.0|0.301
70990937|NCT02065622|141490192|SUPERIORITY|||||||0.502|||||||Breslow-Day test|Breslow-Day test of homogeneity across strata.||||||0.502
70990938|NCT02065622|141490193|SUPERIORITY||Adjusted risk difference|9.9||||0.069|TWO_SIDED|95.0|-0.8|20.6|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||20.6|-0.8|0.069
70990939|NCT02065622|141490193|SUPERIORITY|||||||0.085|||||||Breslow-Day test|Breslow-Day test of homogeneity across strata.||||||0.085
70990940|NCT02065622|141490193|SUPERIORITY||Adjusted risk difference|10.3||||0.045|TWO_SIDED|95.0|0.2|20.4|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||20.4|0.2|0.045
70990941|NCT02065622|141490193|SUPERIORITY|||||||0.106|||||||Breslow-Day test|Breslow-Day test of homogeneity across strata.||||||0.106
70990942|NCT02065622|141490194|SUPERIORITY||Adjusted risk difference|4.2||||0.181|TWO_SIDED|95.0|-2.0|10.5|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||10.5|-2.0|0.181
70990943|NCT02065622|141490194|SUPERIORITY||Adjusted risk difference|3.8||||0.2|TWO_SIDED|95.0|-2.0|9.7|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||9.7|-2.0|0.200
70990944|NCT02065622|141490195|SUPERIORITY||Adjusted risk difference|3.0||||0.3|TWO_SIDED|95.0|-2.6|8.6|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||8.6|-2.6|0.300
71098692|NCT01654250|141705825|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.94||0.042|TWO_SIDED|95.0|-3.8|-0.1|||Mixed Models Analysis|||Hour 8 post-dose deportment subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-0.1|-3.8|0.042
71098693|NCT01654250|141705825|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.94||0.118|TWO_SIDED|95.0|-3.3|0.4|||Mixed Models Analysis|||Hour 10 post-dose deportment sub scale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||0.4|-3.3|0.118
71098694|NCT01654250|141705825|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.94||0.342|TWO_SIDED|95.0|-2.7|1.9|||Mixed Models Analysis|||Hour 12 post-dose deportment sub scale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||1.9|-2.7|0.342
70990945|NCT02065622|141490195|SUPERIORITY||Adjusted risk difference|3.1||||0.254|TWO_SIDED|95.0|-2.2|8.4|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||8.4|-2.2|0.254
70990946|NCT02065622|141490196|SUPERIORITY||Adjusted risk difference|6.5||||0.05|TWO_SIDED|95.0|0.0|13.1|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||13.1|-0.0|0.050
70990947|NCT02065622|141490196|SUPERIORITY||Adjusted risk difference|4.8||||0.131|TWO_SIDED|95.0|-1.4|11.0|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||11.0|-1.4|0.131
71098695|NCT01654250|141705825|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.94||0.962|TWO_SIDED|95.0|-1.8|1.9|||Mixed Models Analysis|||Hour 13 post-dose deportment sub scale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||1.9|-1.8|0.962
70990948|NCT02065622|141490197|SUPERIORITY||Adjusted risk difference|7.3||||0.035|TWO_SIDED|95.0|0.5|14.1|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||14.1|0.5|0.035
71098696|NCT01654250|141705826|SUPERIORITY_OR_OTHER||LS Mean difference|25.3|STANDARD_ERROR_OF_MEAN|11.12||0.024|TWO_SIDED|95.0|3.4|47.1|||Mixed Models Analysis|||Hour 0.75 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||47.1|3.4|0.024
71098697|NCT01654250|141705826|SUPERIORITY_OR_OTHER||LS Mean Difference|36.1|STANDARD_ERROR_OF_MEAN|11.12||0.001|TWO_SIDED|95.0|14.2|57.9|||Mixed Models Analysis|||Hour 2 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||57.9|14.2|0.001
70990949|NCT02065622|141490197|SUPERIORITY||Adjusted risk difference|8.7||||0.008|TWO_SIDED|95.0|2.3|15.1|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||15.1|2.3|0.008
70990950|NCT02065622|141490198|SUPERIORITY||Adjusted risk difference|3.2||||0.16|TWO_SIDED|95.0|-1.3|7.6|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||7.6|-1.3|0.160
70990951|NCT02065622|141490198|SUPERIORITY||Adjusted risk difference|2.9||||0.166|TWO_SIDED|95.0|-1.2|7.1|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||7.1|-1.2|0.166
70990952|NCT02065622|141490199|SUPERIORITY||Adjusted risk difference|8.3||||0.011|TWO_SIDED|95.0|1.9|14.7|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||14.7|1.9|0.011
70990953|NCT02065622|141490199|SUPERIORITY||Adjusted risk difference|7.0||||0.025|TWO_SIDED|95.0|0.9|13.0|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||13.0|0.9|0.025
70990954|NCT02065622|141490200|SUPERIORITY||Adjusted risk difference|4.2||||0.218|TWO_SIDED|95.0|-2.5|10.9|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||10.9|-2.5|0.218
70990955|NCT02065622|141490200|SUPERIORITY||Adjusted risk difference|2.4||||0.456|TWO_SIDED|95.0|-4.0|8.8|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||8.8|-4.0|0.456
70990956|NCT02065622|141490201|SUPERIORITY||Adjusted risk difference|9.5||||0.098|TWO_SIDED|95.0|-1.7|20.8|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||20.8|-1.7|0.098
70990957|NCT02065622|141490201|SUPERIORITY||Adjusted risk difference|9.9||||0.066|TWO_SIDED|95.0|-0.7|20.5|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||20.5|-0.7|0.066
70990958|NCT02065622|141490202|SUPERIORITY||Adjusted risk difference|21.5||||0.002|TWO_SIDED|95.0|7.6|35.4|||Cochran-Mantel-Haenszel|Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.||Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||35.4|7.6|0.002
70990959|NCT02065622|141490202|SUPERIORITY||Adjusted risk difference|19.7||||0.003|TWO_SIDED|95.0|6.6|32.7|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||32.7|6.6|0.003
70990960|NCT02065622|141490203|SUPERIORITY||Adjusted risk difference|11.5||||0.093|TWO_SIDED|95.0|-1.9|25.0|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||25.0|-1.9|0.093
70990961|NCT02065622|141490203|SUPERIORITY||Adjusted risk difference|11.1||||0.088|TWO_SIDED|95.0|-1.7|23.8|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||23.8|-1.7|0.088
70990962|NCT02065622|141490204|SUPERIORITY||Adjusted risk difference|15.9||||0.161|TWO_SIDED|95.0|-6.3|38.2|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||38.2|-6.3|0.161
70990963|NCT02065622|141490204|SUPERIORITY||Adjusted risk difference|10.4||||0.312|TWO_SIDED|95.0|-9.8|30.6|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||30.6|-9.8|0.312
70990964|NCT02065622|141490205|SUPERIORITY||Adjusted risk difference|12.3||||0.272|TWO_SIDED|95.0|-9.7|34.4|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||34.4|-9.7|0.272
70990965|NCT02065622|141490205|SUPERIORITY||Adjusted risk difference|5.3||||0.6|TWO_SIDED|95.0|-14.6|25.2|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||25.2|-14.6|0.600
70990966|NCT02065622|141490206|SUPERIORITY||Adjusted risk difference|23.8||||0.074|TWO_SIDED|95.0|-2.3|49.9|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||49.9|-2.3|0.074
70990967|NCT02065622|141490206|SUPERIORITY||Adjusted risk difference|15.0||||0.21|TWO_SIDED|95.0|-8.5|38.4|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||38.4|-8.5|0.210
70990968|NCT02065622|141490207|SUPERIORITY||Adjusted risk difference|20.0||||0.151|TWO_SIDED|95.0|-7.3|47.3|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||47.3|-7.3|0.151
70990969|NCT02065622|141490207|SUPERIORITY||Adjusted risk difference|12.8||||0.299|TWO_SIDED|95.0|-11.3|36.8|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||36.8|-11.3|0.299
70990970|NCT02065622|141490208|SUPERIORITY||Adjusted risk difference|4.5||||0.422|TWO_SIDED|95.0|-6.4|15.3|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||15.3|-6.4|0.422
70990971|NCT02065622|141490208|SUPERIORITY||Adjusted risk difference|3.4||||0.513|TWO_SIDED|95.0|-6.8|13.6|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||13.6|-6.8|0.513
70990972|NCT02065622|141490209|SUPERIORITY||Adjusted risk difference|3.7||||0.351|TWO_SIDED|95.0|-4.1|11.4|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||11.4|-4.1|0.351
70990973|NCT02065622|141490209|SUPERIORITY||Adjusted risk difference|3.9||||0.292|TWO_SIDED|95.0|-3.3|11.1|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||11.1|-3.3|0.292
70990974|NCT02065622|141490210|SUPERIORITY||Adjusted risk difference|5.4||||0.121|TWO_SIDED|95.0|-1.4|12.1|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||12.1|-1.4|0.121
70990975|NCT02065622|141490210|SUPERIORITY||Adjusted risk difference|6.5||||0.046|TWO_SIDED|95.0|0.1|12.8|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||12.8|0.1|0.046
70990976|NCT02065622|141490211|SUPERIORITY||Adjusted risk difference|7.5||||0.159|TWO_SIDED|95.0|-2.9|17.9|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||17.9|-2.9|0.159
70990977|NCT02065622|141490211|SUPERIORITY||Adjusted risk difference|8.0||||0.109|TWO_SIDED|95.0|-1.8|17.9|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||17.9|-1.8|0.109
70990978|NCT02065622|141490212|SUPERIORITY||Adjusted risk difference|1.4||||0.903|TWO_SIDED|95.0|-21.0|23.8|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||23.8|-21.0|0.903
71039181|NCT03405363|141586134|OTHER|No formal hypotheses were tested.|Adjusted Incidence Rate Ratio|1.48|||||TWO_SIDED|95.0|1.23|1.78|||Poisson regression model||Olodaterol compared to 'other LABA' as reference|"Analysis based on post-hoc population 1.~Adjustments: propensity score decile, previous use of: LAMA, oxygen, inhaled glucocorticoid, respiratory medications, fixed-dose combinations of Short-Acting Beta2- Agonist and Short-Acting Muscarinic Antagonist and systemic antibacterials. COPD severity, number of: all-cause hospitalisations 365 and 180 days, COPD exacerbations 180 and 90 days, COPD hospitalisations 180 and 90 days, and COPD exacerbations 90 days before index date."||1.78|1.23|
71039182|NCT03405363|141586134|OTHER|No formal hypotheses were tested.|Adjusted Incidende Rate Ratio|1.26|||||TWO_SIDED|95.0|0.97|1.64|||Poisson regression model||Olodaterol compared to 'other LABA' as reference|Analysis based on post-hoc population 2. Adjustments: propensity score decile, previous use of: LAMA, oxygen, inhaled glucocorticoid, respiratory medications. COPD severity, number of all-cause hospitalisations 180 days, COPD exacerbations 180 days before cohort entry.||1.64|0.97|
71039183|NCT02533466|141586135|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods.|Median Difference (Final Values)|-0.08||||0.2673|TWO_SIDED|95.0|-1.0|0.0||P-value was calculated from Wilcoxon Rank Sum test.|Wilcoxon Rank Sum test||"Median difference and 95% CI intervals were calculated from the Hodges Lehnmann estimate.~Difference was calculated as reference product minus test product."|||0.0|-1.0|0.2673
71039184|NCT02533466|141586136|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods|Median Difference (Final Values)|-0.92||||0.069|TWO_SIDED|95.0|-1.8|0.0||P-value was calculated from Wilcoxon Rank Sum test.|Wilcoxon Rank Sum Test||"Median difference and 95% CI intervals were calculated from the Hodges Lehnmann estimate.~Difference was calculated as reference product minus test product."|||0.0|-1.8|0.0690
71039185|NCT02533466|141586137|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods|Median Difference (Final Values)|-1.5||||0.068|TWO_SIDED|95.0|-2.7|0.0||P-value was calculated from Wilcoxon Rank Sum test.|Wilcoxon Rank Sum test||"Median difference and 95% CI intervals were calculated from the Hodges Lehnmann estimate.~Difference was calculated as reference product minus test product."|||0.0|-2.7|0.0680
71039186|NCT02533466|141586138|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods|Median Difference (Final Values)|-1.83||||0.0654|TWO_SIDED|95.0|-3.0|0.0||P-value is calculated from Wilcoxon Rank Sum test.|Wilcoxon Rank Sum test.||"Median difference and 95% CI intervals were calculated from the Hodges Lehnmann estimate.~Difference was calculated as reference product minus test product"|||0.0|-3.0|0.0654
71039187|NCT02533466|141586139|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods.|Mean Difference (Final Values)|-1.4||||0.6061|TWO_SIDED|95.0|-6.8|4.1||P value obtained from the ANCOVA analysis|ANCOVA||Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product.|||4.1|-6.8|0.6061
71039188|NCT02533466|141586140|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods.|Mean Difference (Final Values)|-2.3||||0.408|TWO_SIDED|95.0|-7.9|3.3||P value obtained from the ANCOVA analysis.|ANCOVA||Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product|||3.3|-7.9|0.4080
71039189|NCT02533466|141586141|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods.|Median Difference (Final Values)|0.21||||0.4611|TWO_SIDED|95.0|-0.4|0.8||P value obtained from the ANCOVA analysis.|ANCOVA||Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product.|||0.8|-0.4|0.4611
70990979|NCT02065622|141490212|SUPERIORITY||Adjusted risk difference|1.3||||0.901|TWO_SIDED|95.0|-18.8|21.3|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||21.3|-18.8|0.901
70990980|NCT02065622|141490213|SUPERIORITY||Adjusted risk difference|7.7||||0.16|TWO_SIDED|95.0|-3.0|18.4|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||18.4|-3.0|0.160
71039190|NCT02533466|141586142|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods.|Mean Difference (Net)|0.09||||0.3939|TWO_SIDED|95.0|-0.1|0.3||P value obtained from the ANCOVA analysis.|ANCOVA|||||0.3|-0.1|0.3939
71039191|NCT02533466|141586143|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods.|Mean Difference (Final Values)|0.34||||0.7829|TWO_SIDED|95.0|-2.2|2.8||P value obtained from the ANCOVA analysis.|ANCOVA||Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product.|||2.8|-2.2|0.7829
71098698|NCT01654250|141705826|SUPERIORITY_OR_OTHER||LS Mean Difference|34.7|STANDARD_ERROR_OF_MEAN|11.12||0.002|TWO_SIDED|95.0|12.8|56.6|||Mixed Models Analysis|||Hour 4 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||56.6|12.8|0.002
71098699|NCT01654250|141705826|SUPERIORITY_OR_OTHER||LS Mean Difference|29.3|STANDARD_ERROR_OF_MEAN|11.12||0.009|TWO_SIDED|95.0|7.4|51.1|||Mixed Models Analysis|||Hour 8 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||51.1|7.4|0.009
71039192|NCT02533466|141586144|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods|Mean Difference (Final Values)|-0.08||||0.9121|TWO_SIDED|95.0|-1.6|1.4||P value obtained from the ANCOVA analysis.|ANCOVA||Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product.|||1.4|-1.6|0.9121
71039193|NCT02096705|141586145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.0968|<|0.0001|TWO_SIDED|95.0|-1.09|-0.71||P-value for Dapagliflozin vs. placebo|Longitudinal repeated measure analysis||Difference of Dapagliflozin from placebo|||-0.71|-1.09|<0.0001
71039194|NCT02096705|141586146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.69|STANDARD_ERROR_OF_MEAN|4.605|<|0.0001|TWO_SIDED|95.0|-39.76|-21.61|||Longitudinal repeated measure analysis|P-value for Dapagliflozin vs. placebo|Difference of Dapagliflozin from placebo|||-21.61|-39.76|<0.0001
71039195|NCT02096705|141586147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|0.3057|<|0.0001|TWO_SIDED|95.0|-1.98|-0.77||P-value for Dapagliflozin vs. placebo|Longitudinal repeated measure analysis||Difference of Dapagliflozin from placebo|||-0.77|-1.98|<0.0001
71039196|NCT02096705|141586148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.43|STANDARD_ERROR_OF_MEAN|0.5171||0.0059|TWO_SIDED|95.0|-2.45|-0.42||P-value for Dapagliflozin vs. placebo|Longitudinal repeated measure analysis||Difference of Dapagliflozin from placebo|||-0.42|-2.45|0.0059
71039197|NCT01949532|141586149|SUPERIORITY_OR_OTHER||Ratio of geometric means|132.75|||||TWO_SIDED|90.0|70.6|249.63|||||The point estimates of the geometric mean ratios for the PK parameters were calculated by exponentiation of the differences in the least-squares means between the renal impairment group (test) and participants with normal renal function (reference).|||249.63|70.60|
71039198|NCT01949532|141586150|SUPERIORITY_OR_OTHER||Ratio of geometric means|133.62|||||TWO_SIDED|90.0|70.93|251.73||||||||251.73|70.93|
71039199|NCT03105297|141586255|SUPERIORITY|||||||0.0147||95.0||||p-value for comparing between treatments (strip/no strip) were computed from mixed models with treatment \& period as fixed effects, participants as random effects \& time as repeated measures effect.|ANCOVA|||||||0.0147
70923059|NCT03897686|141337155|SUPERIORITY|\[Not specified\]|S-means difference|-143.39|STANDARD_ERROR_OF_MEAN|46.88||0.00267|TWO_SIDED|95.0|-236.09|-50.69||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||It was determined that 144 participants randomized into 2 groups (1:1) would have at least 80% power to detect an effect size of 0.25. Sample size was calculated based on analysis of covariance adjusted for baseline value with fixed factors of group assuming α = 0.05 and 10% discontinuation rate.||-50.69|-236.09|0.00267
70923060|NCT03897686|141337156|SUPERIORITY||LS-means difference|-13.23|STANDARD_ERROR_OF_MEAN|9.995||0.16786|TWO_SIDED|95.0|-32.096|5.638||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in pain WOMAC score at visit 3 (week 6)||5.638|-32.096|0.16786
70923061|NCT03897686|141337156|SUPERIORITY||LS-means difference|-26.695|STANDARD_ERROR_OF_MEAN|9.995||0.00847|TWO_SIDED|95.0|-46.46|-6.93||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in pain WOMAC score at visit 4 (week 13)||-6.93|-46.46|0.00847
70923062|NCT03897686|141337156|SUPERIORITY||LS-means difference|-33.96|STANDARD_ERROR_OF_MEAN|10.29||0.00123|TWO_SIDED|95.0|-54.31|-13.62||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in pain WOMAC score at visit 5 (week 25)||-13.62|-54.31|0.00123
70923063|NCT03897686|141337157|SUPERIORITY||LS-means difference|-0.146|STANDARD_ERROR_OF_MEAN|5.121||0.97733|TWO_SIDED|95.0|-10.271|9.98||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in stiffness WOMAC score, visit 3||9.980|-10.271|0.97733
70923064|NCT03897686|141337157|SUPERIORITY||LS-means difference|-14.5|STANDARD_ERROR_OF_MEAN|5.29||0.00693|TWO_SIDED|95.0|-24.95|-4.04||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in stiffness WOMAC score, visit 4||-4.04|-24.95|0.00693
70923065|NCT03897686|141337157|SUPERIORITY||LS-means difference|-16.18|STANDARD_ERROR_OF_MEAN|4.68||0.00073|TWO_SIDED|95.0|-25.44|-6.92||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in pain WOMAC score at visit 5 (week 25)||-6.92|-25.44|0.00073
70923066|NCT03897686|141337157|SUPERIORITY||LS-means difference|-57.14|STANDARD_ERROR_OF_MEAN|32.1||0.07725|TWO_SIDED|95.0|-120.62|6.33||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in functionality WOMAC score, visit 3||6.33|-120.62|0.07725
71039200|NCT03105297|141586256|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-values are from a one sample t-test using SAS UNIVARIATE on change from baseline.|t-test, 1 sided|||||||<0.0001
71039201|NCT03105297|141586257|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-values are from a one sample t-test using SAS UNIVARIATE on change from baseline.|t-test, 1 sided|||||||<0.0001
71039202|NCT03105297|141586258|SUPERIORITY_OR_OTHER|||||||0.0073||95.0||||p-values are from a one sample t-test using SAS (Statistical Analysis System) UNIVARIATE on change from baseline.|t-test, 1 sided|||||||0.0073
71039203|NCT00714051|141586282|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||Chi-squared|||The number of participants who fell on the tripping trial in each group were compared using Chi-square analysis||||0.45
71098700|NCT01654250|141705826|SUPERIORITY_OR_OTHER||LS Mean Difference|12.5|STANDARD_ERROR_OF_MEAN|11.12||0.261|TWO_SIDED|95.0|-9.3|34.4|||Mixed Models Analysis|||Hour 10 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||34.4|-9.3|0.261
71039204|NCT03868631|141586283|SUPERIORITY||||||<|0.05|||||||multilevel models for change|||Between-group differences at baseline were compared using independent t-tests. Multilevel models for change (MLM) were used to determine differences between groups over time for study outcomes. Age, sex, and number of sessions missed were included as covariates. Time and time by group interactions were examined. Analyses were conducted using IBM SPSS Statistics version 23. Significance was set at p\<0.05.||||<0.05
71039205|NCT01929681|141586292|SUPERIORITY||||||<|0.049|||||||Regression, Linear|||||||<0.049
71039206|NCT01929681|141586293|SUPERIORITY||||||<|0.182|||||||Regression, Linear|||||||<0.182
71039207|NCT01929681|141586294|SUPERIORITY||||||<|0.449|||||||Regression, Linear|Mixed effects analysis||||||<0.449
71039208|NCT01929681|141586295|SUPERIORITY||||||<|0.444|||||||Regression, Linear|Mixed effects analysis||||||<0.444
71039209|NCT01929681|141586296|SUPERIORITY||||||<|0.182|||||||Regression, Linear|Mixed effects analysis||||||<0.182
70990981|NCT02065622|141490213|SUPERIORITY||Adjusted risk difference|9.1||||0.076|TWO_SIDED|95.0|-0.9|19.1|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||19.1|-0.9|0.076
71039210|NCT01073631|141586306|SUPERIORITY_OR_OTHER||Efficacy rate (percent)|78.9|||||TWO_SIDED|95.0|75.07|82.73|||Normal approximation to binomial||Confidence Interval (CI) by normal approximation to binomial.|Efficacy Rate (treatment effective) = Percentage of evaluable participants with clinical response of cure or improvement||82.73|75.07|
70923067|NCT03897686|141337157|SUPERIORITY||LS-means difference|-103.27|STANDARD_ERROR_OF_MEAN|33.92||0.00279|TWO_SIDED|95.0|-170.35|-36.2||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in functionality WOMAC score, visit 4||-36.20|-170.35|0.00279
70990982|NCT02065622|141490214|SUPERIORITY||Adjusted risk difference|7.3||||0.207|TWO_SIDED|95.0|-4.0|18.6|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||18.6|-4.0|0.207
70990983|NCT02065622|141490214|SUPERIORITY||Adjusted risk difference|4.2||||0.44|TWO_SIDED|95.0|-6.4|14.8|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||14.8|-6.4|0.440
71039211|NCT01971554|141586308|SUPERIORITY_OR_OTHER||Difference in the least squares means|30.8|||||TWO_SIDED|90.0|11.3|50.3|||||A constrained longitudinal data analysis (cLDA) model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.|||50.3|11.3|
71098701|NCT01654250|141705826|SUPERIORITY_OR_OTHER||LS Mean Difference|15.1|STANDARD_ERROR_OF_MEAN|11.12||0.175|TWO_SIDED|95.0|-6.7|37.0|||Mixed Models Analysis|||Hour 12 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||37.0|-6.7|0.175
71098702|NCT01654250|141705826|SUPERIORITY_OR_OTHER||LS Mean Difference|18.7|STANDARD_ERROR_OF_MEAN|11.12||0.094|TWO_SIDED|95.0|-3.2|40.5|||Mixed Models Analysis|||Hour 13 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||40.5|-3.2|0.094
70990984|NCT03492463|141490216|SUPERIORITY|||||||0.01|||||||Regression, Linear|||Due to time and budget constraints a blinded decision was made and approved by the funding agency to limit further enrollment to the two conditions that provided nicotine patches. The primary (one-tailed) test compared Nicotine e-cigs + Nicotine patches to Non-nicotine e-cigs + Nicotine patches.||||0.01
70990985|NCT03492463|141490217|SUPERIORITY|||||||0.8|||||||ANOVA|||||||0.8
70990986|NCT03492463|141490218|SUPERIORITY|||||||0.5|||||||ANOVA|||||||0.5
70990987|NCT06704178|141490220|SUPERIORITY|||||||0.488445|||||||Multiple t-tests|||||||0.488445
70990988|NCT06704178|141490221|SUPERIORITY|Between-group comparison.||||||0.98317||||||Between-group comparison.|t-test, 2 sided|||||||0.98317
70990989|NCT06704178|141490222|SUPERIORITY|||||||0.98317|||||||t-test, 2 sided|||||||0.98317
70990990|NCT06704178|141490223|SUPERIORITY|||||||0.919209|||||||t-test, 2 sided|||||||0.919209
70990991|NCT06704178|141490224|SUPERIORITY|||||||0.919209|||||||t-test, 2 sided|||||||0.919209
70990992|NCT06704178|141490225|SUPERIORITY|||||||0.954882||||||Comparison at Month 2|t-test, 2 sided|||||||0.954882
70990993|NCT06704178|141490225|SUPERIORITY|||||||0.246176||||||Comparison at Month 4|t-test, 2 sided|||||||0.246176
70990994|NCT06704178|141490225|SUPERIORITY|||||||0.954882||||||Comparison at Month 6|t-test, 2 sided|||||||0.954882
71098703|NCT01654250|141705826|SUPERIORITY_OR_OTHER||LS Mean Difference|22.6|STANDARD_ERROR_OF_MEAN|11.44||0.049|TWO_SIDED|95.0|0.1|45.1|||Mixed Models Analysis|||Hour 0.75 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||45.1|0.1|0.049
70990995|NCT06704178|141490226|SUPERIORITY|||||||0.483382||||||Comparison at Month 2|t-test, 2 sided|||||||0.483382
70990996|NCT06704178|141490226|SUPERIORITY|||||||0.483382||||||Comparison at Month 4|t-test, 2 sided|||||||0.483382
70990997|NCT06704178|141490226|SUPERIORITY|||||||0.726742||||||Comparison at Month 6|t-test, 2 sided|||||||0.726742
70990998|NCT06704178|141490227|SUPERIORITY|||||||0.999216||||||Comparison at Month 1|t-test, 2 sided|||||||0.999216
70990999|NCT06704178|141490227|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
70991000|NCT06704178|141490227|SUPERIORITY|||||||0.559556||||||Comparison at Month 3|t-test, 2 sided|||||||0.559556
70991001|NCT06704178|141490227|SUPERIORITY|||||||0.999984||||||Comparison at Month 4|t-test, 2 sided|||||||0.999984
70991002|NCT06704178|141490227|SUPERIORITY|||||||0.952545||||||Comparison at Month 5|t-test, 2 sided|||||||0.952545
70991003|NCT06704178|141490227|SUPERIORITY|||||||0.998367||||||Comparison at Month 6|t-test, 2 sided|||||||0.998367
70991004|NCT06704178|141490228|SUPERIORITY|||||||0.999851||||||Comparison at Month 1|t-test, 2 sided|||||||0.999851
70991005|NCT06704178|141490228|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
70991006|NCT06704178|141490228|SUPERIORITY|||||||0.999801|||||||t-test, 2 sided|||||||0.999801
71039212|NCT01971554|141586308|SUPERIORITY_OR_OTHER||Difference in the least squares means|36.0|||||TWO_SIDED|90.0|20.0|51.9|||||A cLDA model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.|||51.9|20.0|
71098704|NCT01654250|141705826|SUPERIORITY_OR_OTHER||LS Mean Difference|34.4|STANDARD_ERROR_OF_MEAN|11.44||0.003|TWO_SIDED|95.0|11.9|56.9|||Mixed Models Analysis|||Hour 2 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||56.9|11.9|0.003
71098705|NCT01654250|141705826|SUPERIORITY_OR_OTHER||LS Mean Difference|32.9|STANDARD_ERROR_OF_MEAN|11.44||0.004|TWO_SIDED|95.0|10.5|55.4|||Mixed Models Analysis|||Hour 4 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||55.4|10.5|0.004
71098706|NCT01654250|141705826|SUPERIORITY_OR_OTHER||LS Mean Difference|27.0|STANDARD_ERROR_OF_MEAN|11.44||0.019|TWO_SIDED|95.0|4.5|49.5|||Mixed Models Analysis|||Hour 8 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||49.5|4.5|0.019
71098707|NCT01654250|141705826|SUPERIORITY_OR_OTHER||LS Mean difference|8.6|STANDARD_ERROR_OF_MEAN|11.44||0.451|TWO_SIDED|95.0|-13.9|31.1|||Mixed Models Analysis|||Hour 10 (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||31.1|-13.9|0.451
71098708|NCT01654250|141705826|SUPERIORITY_OR_OTHER||LS Mean Difference|9.8|STANDARD_ERROR_OF_MEAN|11.44||0.394|TWO_SIDED|95.0|-12.7|32.2|||Mixed Models Analysis|||Hour 12 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||32.2|-12.7|0.394
71098709|NCT01654250|141705826|SUPERIORITY_OR_OTHER||LS Mean difference|8.3|STANDARD_ERROR_OF_MEAN|11.44||0.466|TWO_SIDED|95.0|-14.1|30.8|||Mixed Models Analysis|||Hour 13 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||30.8|-14.1|0.466
71098710|NCT00504556|141705833|SUPERIORITY_OR_OTHER|||||||0.367|TWO_SIDED||||||Fisher Exact|||All bleeds||||.367
71098711|NCT00504556|141705833|SUPERIORITY_OR_OTHER|||||||0.104|TWO_SIDED||||||Fisher Exact|||All bleeds||||.104
71098712|NCT00504556|141705833|SUPERIORITY_OR_OTHER|||||||0.864|TWO_SIDED||||||Fisher Exact|||All bleeds||||.864
71098713|NCT00504556|141705833|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Fisher Exact|||All bleeds||||.002
71098714|NCT00504556|141705833|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Major or Clinically Relevant (CR) non-major bleeding||||1.000
71098715|NCT00504556|141705833|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Fisher Exact|||Major or Clinically Relevant (CR) non-major bleeding||||0.029
71098716|NCT00504556|141705833|SUPERIORITY_OR_OTHER|||||||0.807|TWO_SIDED||||||Fisher Exact|||Major or Clinically Relevant (CR) non-major bleeding||||0.807
71098717|NCT00504556|141705833|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Fisher Exact|||Major or Clinically Relevant (CR) non-major bleeding||||0.002
71098718|NCT00504556|141705833|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Major bleeds||||1.000
71098719|NCT00504556|141705833|SUPERIORITY_OR_OTHER|||||||0.119|TWO_SIDED||||||Fisher Exact|||Major bleeds||||0.119
71098720|NCT00504556|141705833|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Major bleeds||||1.000
71098721|NCT00504556|141705833|SUPERIORITY_OR_OTHER|||||||0.023|TWO_SIDED||||||Fisher Exact|||Major bleeds||||0.023
71098722|NCT03142451|141705867|SUPERIORITY||Mean Difference (Final Values)|2.21|STANDARD_ERROR_OF_MEAN|0.749||0.0031|TWO_SIDED|95.0|0.75|3.68|||ANCOVA|Analysis of covariance (ANCOVA) model includes treatment, baseline inflammatory lesion count, and analysis center.||||3.68|0.75|0.0031
71098723|NCT03142451|141705868|SUPERIORITY||Risk Ratio (RR)|1.21||||0.0273|TWO_SIDED|95.0|1.022|1.434||The p-value is for the null hypothesis that the combined risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Test Stratified by Analysis Center||||1.434|1.022|0.0273
71098724|NCT03142451|141705869|SUPERIORITY||Risk Ratio (RR)|1.21||||0.0171|TWO_SIDED|95.0|1.028|1.425||The p-value is for the null hypothesis that the combined risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Test Stratified by Analysis Center||||1.425|1.028|0.0171
71098725|NCT03142451|141705870|SUPERIORITY||Mean Difference (Final Values)|7.62|STANDARD_ERROR_OF_MEAN|2.626||0.0039|TWO_SIDED|95.0|2.46|12.77|||ANCOVA|ANCOVA model includes treatment, Baseline inflammatory lesion count, and analysis center.||||12.77|2.46|0.0039
71098726|NCT03142451|141705871|SUPERIORITY||Mean Difference (Final Values)|2.63|STANDARD_ERROR_OF_MEAN|0.747||0.0004|TWO_SIDED|95.0|1.16|4.09|||ANCOVA|ANCOVA model included treatment, Baseline inflammatory lesion count, and analysis center.||Statistical analysis for Week 4||4.09|1.16|0.0004
71098727|NCT03142451|141705871|SUPERIORITY||Mean Difference (Final Values)|3.09|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED|95.0|1.62|4.56|||ANCOVA|ANCOVA model included treatment, Baseline inflammatory lesion count, and analysis center.||Statistical analysis for Week 8||4.56|1.62|<0.0001
71098728|NCT03142451|141705872|SUPERIORITY||Risk Ratio (RR)|1.685||||0.0201|TWO_SIDED|95.0|1.085|2.616||P-value is for the null hypothesis that the risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by analysis center.||Statistical analysis for Week 4||2.616|1.085|0.0201
70991007|NCT06704178|141490228|SUPERIORITY|||||||0.999984||||||Comparison at Month 4|t-test, 2 sided|||||||0.999984
70991008|NCT06704178|141490228|SUPERIORITY|||||||0.993223||||||Comparison at Month 5|t-test, 2 sided|||||||0.993223
70991009|NCT06704178|141490228|SUPERIORITY|||||||0.999567||||||Comparison at Month 6|t-test, 2 sided|||||||0.999567
70991010|NCT06704178|141490229|SUPERIORITY|||||||0.999851||||||Comparison at Month 1|t-test, 2 sided|||||||0.999851
70991011|NCT06704178|141490229|SUPERIORITY|||||||0.999838||||||Comparison at Month 2|t-test, 2 sided|||||||0.999838
70991012|NCT06704178|141490229|SUPERIORITY|||||||0.991697||||||Comparison at Month 3|t-test, 2 sided|||||||0.991697
70991013|NCT06704178|141490229|SUPERIORITY|||||||0.999984||||||Comparison at Month 4|t-test, 2 sided|||||||0.999984
70991014|NCT06704178|141490229|SUPERIORITY|||||||0.581904||||||Comparison at Month 5|t-test, 2 sided|||||||0.581904
70991015|NCT06704178|141490229|SUPERIORITY|||||||0.999866||||||Comparison at Month 6|t-test, 2 sided|||||||0.999866
71039213|NCT01971554|141586308|SUPERIORITY_OR_OTHER||Difference in the least squares means|54.1|||||TWO_SIDED|90.0|38.1|70.0|||||A cLDA model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.|||70.0|38.1|
70991016|NCT06704178|141490230|SUPERIORITY|||||||0.999835||||||Comparison at Month 1|t-test, 2 sided|||||||0.999835
70991017|NCT06704178|141490230|SUPERIORITY|||||||0.962016||||||Comparison at Month 2|t-test, 2 sided|||||||0.962016
70991018|NCT06704178|141490230|SUPERIORITY|||||||0.995044||||||Comparison at Month 3|t-test, 2 sided|||||||0.995044
70991019|NCT06704178|141490230|SUPERIORITY|||||||0.998665||||||Comparison at Month 4|t-test, 2 sided|||||||0.998665
70991020|NCT06704178|141490230|SUPERIORITY|||||||0.999816||||||Comparison at Month 5|t-test, 2 sided|||||||0.999816
70991021|NCT06704178|141490230|SUPERIORITY|||||||0.999567||||||Comparison at Month 6|t-test, 2 sided|||||||0.999567
70991022|NCT06704178|141490231|SUPERIORITY|||||||0.999851||||||Comparison at Month 1|t-test, 2 sided|||||||0.999851
70991023|NCT06704178|141490231|SUPERIORITY|||||||0.999524||||||Comparison at Month 2|t-test, 2 sided|||||||0.999524
70991024|NCT06704178|141490231|SUPERIORITY|||||||0.576782||||||Comparison at Month 3|t-test, 2 sided|||||||0.576782
70991025|NCT06704178|141490231|SUPERIORITY|||||||0.772865||||||Comparison at Month 4|t-test, 2 sided|||||||0.772865
70991026|NCT06704178|141490231|SUPERIORITY|||||||0.91384||||||Comparison at Month 5|t-test, 2 sided|||||||0.91384
70991027|NCT06704178|141490231|SUPERIORITY|||||||0.992841||||||Comparison at Month 6|t-test, 2 sided|||||||0.992841
70991028|NCT06704178|141490232|SUPERIORITY|||||||0.999732||||||Comparison at Month 1|t-test, 2 sided|||||||0.999732
70991029|NCT06704178|141490232|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
70991030|NCT06704178|141490232|SUPERIORITY|||||||0.999801||||||Comparison at Month 3|t-test, 2 sided|||||||0.999801
70991031|NCT06704178|141490232|SUPERIORITY||||||>|0.999999||||||Comparison at Month 4|t-test, 2 sided|||||||>0.999999
70991032|NCT06704178|141490232|SUPERIORITY|||||||0.999816||||||Comparison at Month 5|t-test, 2 sided|||||||0.999816
70991033|NCT06704178|141490232|SUPERIORITY||||||>|0.999999||||||Comparison at Month 6|t-test, 2 sided|||||||>0.999999
70991034|NCT06704178|141490233|SUPERIORITY|||||||0.999851||||||Comparison at Month 1|t-test, 2 sided|||||||0.999851
70991035|NCT06704178|141490233|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
70991036|NCT06704178|141490233|SUPERIORITY|||||||0.998326||||||Comparison at Month 3|t-test, 2 sided|||||||0.998326
70991037|NCT06704178|141490233|SUPERIORITY|||||||0.998665||||||Comparison at Month 4|t-test, 2 sided|||||||0.998665
70991038|NCT06704178|141490233|SUPERIORITY|||||||0.999816||||||Comparison at Month 5|t-test, 2 sided|||||||0.999816
70991039|NCT06704178|141490233|SUPERIORITY|||||||0.998846||||||Comparison at Month 6|t-test, 2 sided|||||||0.998846
70991040|NCT06704178|141490234|SUPERIORITY|||||||0.999387||||||Comparison at Month 1|t-test, 2 sided|||||||0.999387
70991041|NCT06704178|141490234|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
70991042|NCT06704178|141490234|SUPERIORITY||||||>|0.999999||||||Comparison at Month 3|t-test, 2 sided|||||||>0.999999
70991043|NCT06704178|141490234|SUPERIORITY|||||||0.999984||||||Comparison at Month 4|t-test, 2 sided|||||||0.999984
70991044|NCT06704178|141490234|SUPERIORITY|||||||0.999816||||||Comparison at Month 5|t-test, 2 sided|||||||0.999816
70991045|NCT06704178|141490234|SUPERIORITY|||||||0.998367||||||Comparison at Month 6|t-test, 2 sided|||||||0.998367
70991046|NCT06704178|141490235|SUPERIORITY|||||||0.999975||||||Comparison at Month 1|t-test, 2 sided|||||||0.999975
70991047|NCT06704178|141490235|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
70991048|NCT06704178|141490235|SUPERIORITY|||||||0.999801||||||Comparison at Month 3|t-test, 2 sided|||||||0.999801
70991049|NCT06704178|141490235|SUPERIORITY|||||||0.999984||||||Comparison at Month 4|t-test, 2 sided|||||||0.999984
70991050|NCT06704178|141490235|SUPERIORITY|||||||0.960874||||||Comparison at Month 5|t-test, 2 sided|||||||0.960874
70991051|NCT06704178|141490235|SUPERIORITY|||||||0.999567||||||Comparison at Month 6|t-test, 2 sided|||||||0.999567
70991052|NCT06704178|141490236|SUPERIORITY|||||||0.981906||||||Comparison at Month 1|t-test, 2 sided|||||||0.981906
70991053|NCT06704178|141490236|SUPERIORITY|||||||0.945027||||||Comparison at Month 2|t-test, 2 sided|||||||0.945027
70991054|NCT06704178|141490236|SUPERIORITY|||||||0.767795||||||Comparison at Month 3|t-test, 2 sided|||||||0.767795
70991055|NCT06704178|141490236|SUPERIORITY|||||||0.996139||||||Comparison at Month 4|t-test, 2 sided|||||||0.996139
70991056|NCT06704178|141490236|SUPERIORITY|||||||0.952378||||||Comparison at Month 5|t-test, 2 sided|||||||0.952378
70991057|NCT06704178|141490236|SUPERIORITY|||||||0.998846||||||Comparison at Month 6|t-test, 2 sided|||||||0.998846
70991058|NCT06704178|141490237|SUPERIORITY|||||||0.55783||||||Comparison at Month 1|t-test, 2 sided|||||||0.55783
70991059|NCT06704178|141490237|SUPERIORITY|||||||0.987949||||||Comparison at Month 2|t-test, 2 sided|||||||0.987949
70991060|NCT06704178|141490237|SUPERIORITY|||||||0.576782||||||Comparison at Month 3|t-test, 2 sided|||||||0.576782
70991061|NCT06704178|141490237|SUPERIORITY|||||||0.998665||||||Comparison at Month 4|t-test, 2 sided|||||||0.998665
70991062|NCT06704178|141490237|SUPERIORITY|||||||0.989226||||||Comparison at Month 5|t-test, 2 sided|||||||0.989226
70991063|NCT06704178|141490237|SUPERIORITY|||||||0.999567||||||Comparison at Month 6|t-test, 2 sided|||||||0.999567
70991064|NCT06704178|141490238|SUPERIORITY|||||||0.795476||||||Comparison at Month 1|t-test, 2 sided|||||||0.795476
70991065|NCT06704178|141490238|SUPERIORITY|||||||0.977286||||||Comparison at Month 2|t-test, 2 sided|||||||0.977286
70991066|NCT06704178|141490238|SUPERIORITY|||||||0.559556||||||Comparison at Month 3|t-test, 2 sided|||||||0.559556
70991067|NCT06704178|141490238|SUPERIORITY|||||||0.997753||||||Comparison at Month 4|t-test, 2 sided|||||||0.997753
70991068|NCT06704178|141490238|SUPERIORITY|||||||0.952378||||||Comparison at Month 5|t-test, 2 sided|||||||0.952378
71098729|NCT03142451|141705872|SUPERIORITY||Risk Ratio (RR)|1.191||||0.1278|TWO_SIDED|95.0|0.951|1.492||P-value is for the null hypothesis that the risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by analysis center.||Statistical analysis for Week 8||1.492|0.951|0.1278
70991069|NCT06704178|141490238|SUPERIORITY|||||||0.988108||||||Comparison at Month 6|t-test, 2 sided|||||||0.988108
70991070|NCT06704178|141490239|SUPERIORITY|||||||0.995367||||||Comparison at Month 1|t-test, 2 sided|||||||0.995367
70991071|NCT06704178|141490239|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
70991072|NCT06704178|141490239|SUPERIORITY|||||||0.974102||||||Comparison at Month 3|t-test, 2 sided|||||||0.974102
70991073|NCT06704178|141490239|SUPERIORITY|||||||0.998665||||||Comparison at Month 4|t-test, 2 sided|||||||0.998665
70991074|NCT06704178|141490239|SUPERIORITY|||||||0.999816||||||Comparison at Month 5|t-test, 2 sided|||||||0.999816
70991075|NCT06704178|141490239|SUPERIORITY|||||||0.999567||||||Comparison at Month 6|t-test, 2 sided|||||||0.999567
70991076|NCT06704178|141490240|SUPERIORITY|||||||0.882016||||||Comparison at Month 1|t-test, 2 sided|||||||0.882016
70991077|NCT06704178|141490240|SUPERIORITY|||||||0.860406||||||Comparison at Month 2|t-test, 2 sided|||||||0.860406
70991078|NCT06704178|141490240|SUPERIORITY|||||||0.958944||||||Comparison at Month 3|t-test, 2 sided|||||||0.958944
70991079|NCT06704178|141490240|SUPERIORITY|||||||0.998816||||||Comparison at Month 4|t-test, 2 sided|||||||0.998816
70991080|NCT06704178|141490240|SUPERIORITY|||||||0.989226||||||Comparison at Month 5|t-test, 2 sided|||||||0.989226
70991081|NCT06704178|141490240|SUPERIORITY|||||||0.999296||||||Comparison at Month 6|t-test, 2 sided|||||||0.999296
70991082|NCT06704178|141490241|SUPERIORITY|||||||0.999975||||||Comparison at Month 1.|t-test, 2 sided|||||||0.999975
70991083|NCT06704178|141490241|SUPERIORITY|||||||0.977286||||||Comparison at Month 2|t-test, 2 sided|||||||0.977286
70991084|NCT06704178|141490241|SUPERIORITY|||||||0.999||||||Comparison at Month 3.|t-test, 2 sided|||||||0.999
70991085|NCT06704178|141490241|SUPERIORITY|||||||0.999984||||||Comparison at Month 4.|t-test, 2 sided|||||||0.999984
70991086|NCT06704178|141490241|SUPERIORITY|||||||0.986557||||||Comparison at Month 5.|t-test, 2 sided|||||||0.986557
70991087|NCT06704178|141490241|SUPERIORITY|||||||0.998367||||||Comparison at Month 6.|t-test, 2 sided|||||||0.998367
70991088|NCT06704178|141490242|SUPERIORITY|||||||0.999851||||||Comparison at Month 1.|t-test, 2 sided|||||||0.999851
70991089|NCT06704178|141490242|SUPERIORITY|||||||0.999779||||||Comparison at Month 2.|t-test, 2 sided|||||||0.999779
70991090|NCT06704178|141490242|SUPERIORITY|||||||0.999801||||||Comparison at Month 3.|t-test, 2 sided|||||||0.999801
70991091|NCT06704178|141490242|SUPERIORITY|||||||0.998467||||||Comparison at Month 4.|t-test, 2 sided|||||||0.998467
70991092|NCT06704178|141490242|SUPERIORITY|||||||0.999816||||||Comparison at Month 5.|t-test, 2 sided|||||||0.999816
70991093|NCT06704178|141490242|SUPERIORITY|||||||0.998846||||||Comparison at Month 6.|t-test, 2 sided|||||||0.998846
70991094|NCT06704178|141490243|SUPERIORITY||||||>|0.999999||||||Comparison at Month 1.|t-test, 2 sided|||||||>0.999999
70991095|NCT06704178|141490243|SUPERIORITY|||||||0.999779||||||Comparison at Month 2.|t-test, 2 sided|||||||0.999779
70991096|NCT06704178|141490243|SUPERIORITY|||||||0.999801||||||Comparison at Month 3.|t-test, 2 sided|||||||0.999801
70991097|NCT06704178|141490243|SUPERIORITY|||||||0.963236||||||Comparison at Month 4.|t-test, 2 sided|||||||0.963236
70991098|NCT06704178|141490243|SUPERIORITY|||||||0.999816||||||Comparison at Month 5.|t-test, 2 sided|||||||0.999816
70991099|NCT06704178|141490243|SUPERIORITY|||||||0.737995||||||Comparison at Month 6.|t-test, 2 sided|||||||0.737995
70991100|NCT06704178|141490244|SUPERIORITY|||||||0.0003||||||Within-group analysis only.|t-test, 2 sided|||||||0.0003
70991101|NCT06704178|141490245|SUPERIORITY|||||||0.2698||||||Within-group analysis only.|t-test, 2 sided|||||||0.2698
70991102|NCT06704178|141490246|SUPERIORITY|||||||0.2698||||||Within-group analysis only.|t-test, 2 sided|||||||0.2698
70991103|NCT06704178|141490247|SUPERIORITY|||||||0.2137||||||Within-group analysis only.|t-test, 2 sided|||||||0.2137
70991104|NCT06704178|141490248|SUPERIORITY|||||||0.8639||||||Within-group analysis only.|t-test, 2 sided|||||||0.8639
70991105|NCT06704178|141490249|SUPERIORITY|||||||0.239||||||Within-group analysis only.|t-test, 2 sided|||||||0.239
70991106|NCT06704178|141490250|SUPERIORITY|||||||0.6088||||||Within-group analysis only.|t-test, 2 sided|||||||0.6088
70991107|NCT06704178|141490251|SUPERIORITY|||||||0.5738||||||Within-group analysis only.|t-test, 2 sided|||||||0.5738
70991108|NCT06704178|141490252|SUPERIORITY|||||||0.6088||||||Within-group analysis only.|t-test, 2 sided|||||||0.6088
70991109|NCT06704178|141490253|SUPERIORITY|||||||0.4942||||||Within-group analysis only.|t-test, 2 sided|||||||0.4942
70991110|NCT06704178|141490254|SUPERIORITY|||||||0.7419||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.7419
70991111|NCT06704178|141490254|SUPERIORITY|||||||0.0033||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0033
70991112|NCT06704178|141490254|SUPERIORITY|||||||0.0219||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0219
71098730|NCT03777176|141705893|SUPERIORITY|The negative binomial regression used region and treatment group as fixed effects, and Baseline hypoglycemic rate as covariate and number of hypoglycemic events during Weeks 2-4 as dependent variable.|Event rate ratio|0.85||||0.5028|TWO_SIDED|95.0|0.54|1.36|||Negative binomial regression|||The primary analysis was performed as a negative binominal regression analysis on the difference of the SMPG-detected hypoglycemia episode rate between treatment groups over the Weeks 2-4.||1.36|0.54|0.5028
71098731|NCT03777176|141705894|SUPERIORITY||Mean Difference (Net)|0.84||||0.6433|TWO_SIDED|95.0|-2.71|4.39||The P value should be interpreted with caution given the procedural issues (hypoglycemia at the beginning of the test, test meals not being the same, and some children only having 1 test) which affected the preplanned statistical evaluation.|ANCOVA|||||4.39|-2.71|0.6433
71098732|NCT03777176|141705895|SUPERIORITY||Mean Difference (Net)|0.15||||0.9653|TWO_SIDED|95.0|-6.48|6.78||There was 1 missing value at Baseline for the dasiglucagon + standard of care group.|ANCOVA|||||6.78|-6.48|0.9653
71098733|NCT03777176|141705896|SUPERIORITY||Event rate ratio|0.93||||0.8114|TWO_SIDED|95.0|0.49|1.74|||Negative binominal regression|The negative binomial regression used region and treatment group as fixed effects, and Baseline hypoglycemic rate as covariate.||||1.74|0.49|0.8114
71098734|NCT03992482|141705929|OTHER|||||||1|||||||Kruskal-Wallis|||||||1.000
71098735|NCT03992482|141705930|OTHER|||||||0.0044|||||||Mixed Models Analysis|||||||0.0044
71098736|NCT03992482|141705931|OTHER|||||||0.0002|||||||Mixed Models Analysis|||||||0.0002
70991113|NCT06704178|141490255|SUPERIORITY|||||||0.7708||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.7708
70991114|NCT06704178|141490255|SUPERIORITY|||||||0.239||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.239
70991115|NCT06704178|141490255|SUPERIORITY|||||||0.006||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.006
70991116|NCT06704178|141490256|SUPERIORITY|||||||0.0219||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0219
70991117|NCT06704178|141490256|SUPERIORITY|||||||0.0001||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0001
70991118|NCT06704178|141490256|SUPERIORITY||||||<|0.0001||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||<0.0001
70991119|NCT06704178|141490257|SUPERIORITY|||||||0.0695||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0695
70991120|NCT06704178|141490257|SUPERIORITY|||||||0.0124||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0124
70991121|NCT06704178|141490257|SUPERIORITY|||||||0.0016||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0016
70991122|NCT06704178|141490258|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991123|NCT06704178|141490258|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991124|NCT06704178|141490258|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991125|NCT06704178|141490258|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991126|NCT06704178|141490258|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991127|NCT06704178|141490258|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991128|NCT06704178|141490259|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991129|NCT06704178|141490259|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991130|NCT06704178|141490259|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991131|NCT06704178|141490259|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991132|NCT06704178|141490259|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991133|NCT06704178|141490259|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991134|NCT06704178|141490260|SUPERIORITY|||||||0.4598||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.4598
70991135|NCT06704178|141490260|SUPERIORITY|||||||0.23||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.23
70991136|NCT06704178|141490260|SUPERIORITY|||||||0.0806||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0806
70991137|NCT06704178|141490260|SUPERIORITY|||||||0.0969||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0969
70991138|NCT06704178|141490260|SUPERIORITY|||||||0.6098||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.6098
70991139|NCT06704178|141490260|SUPERIORITY|||||||0.0369||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0369
70991140|NCT06704178|141490261|SUPERIORITY|||||||0.0384||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0384
70991141|NCT06704178|141490261|SUPERIORITY|||||||0.6328||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.6328
70991142|NCT06704178|141490261|SUPERIORITY|||||||0.0026||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0026
70991143|NCT06704178|141490261|SUPERIORITY|||||||0.0012||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0012
70991144|NCT06704178|141490261|SUPERIORITY|||||||0.0118||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0118
70991145|NCT06704178|141490261|SUPERIORITY|||||||0.0221||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0221
70991146|NCT06704178|141490262|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991147|NCT06704178|141490262|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991148|NCT06704178|141490262|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991149|NCT06704178|141490262|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991150|NCT06704178|141490262|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991151|NCT06704178|141490262|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991152|NCT06704178|141490263|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70923068|NCT03897686|141337157|SUPERIORITY||LS-means difference|-133.29|STANDARD_ERROR_OF_MEAN|35.26||0.00023|TWO_SIDED|95.0|-203.03|-63.55||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in functionality WOMAC score, visit 5||-63.55|-203.03|0.00023
70923069|NCT03897686|141337158|SUPERIORITY||||||<|0.005||||||The level of significance was set to p \<0.05.|Chi-squared|P-value generated by Chi-squared test was ≤0.005 for each time point.||The Chi-Square test was used to determine whether there was a statistically significant difference in disposition of results between two groups.||||<0.005
70923070|NCT03897686|141337159|SUPERIORITY||||||<|0.005||||||The level of significance was set to p \<0.05.|Chi-squared|P-value generated by Chi-squared test was ≤0.005 for each time point.||The Chi-Square test was used to determine whether there was a statistically significant difference in disposition of results between two groups.||||<0.005
70923071|NCT03897686|141337161|SUPERIORITY|||||||0.05||||||The threshold for statistical significance was p \<0.05.|ANCOVA|||The mean number of paracetamol tablets was calculated taking into account only patients who had received paracetamol. ANCOVA was used to detect a difference in means of 2 groups at visit 3 (week 6).||||0.050
70923072|NCT03897686|141337161|SUPERIORITY|||||||0.004||||||The threshold for statistical significance was p \<0.05.|ANCOVA|||The mean number of paracetamol tablets was calculated taking into account only patients who had received paracetamol. ANCOVA was used to detect a difference in means of 2 groups at visit 4 (week 13).||||0.004
70923073|NCT02697136|141337208|OTHER|Linear mixed model to test for superiority and non-inferiority. Equivalence was defined as a difference of less than 6.7% in MVWA, based on a pilot study. Using an assumed standard deviation of 4.5% and a 2:1 randomization scheme to maximize exposure to active drug, 16 completing patients in the CER-001 group and 8 in the placebo group (24 total completers for mITT) would yield 90% power to detect a difference from baseline versus placebo of 6.7%, using two-tailed testing with α=0.05.|Difference in LS Means|-0.08||||0.185|TWO_SIDED|95.0|-1.9|0.4|||Mixed Models Analysis|||||0.4|-1.9|0.185
70991153|NCT06704178|141490263|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991154|NCT06704178|141490263|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991155|NCT06704178|141490263|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991156|NCT06704178|141490263|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991157|NCT06704178|141490263|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991158|NCT06704178|141490264|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991159|NCT06704178|141490264|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991160|NCT06704178|141490264|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991161|NCT06704178|141490264|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991162|NCT06704178|141490264|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991163|NCT06704178|141490264|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991164|NCT06704178|141490265|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991165|NCT06704178|141490265|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991166|NCT06704178|141490265|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991167|NCT06704178|141490265|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991168|NCT06704178|141490265|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991169|NCT06704178|141490265|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991170|NCT06704178|141490266|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991171|NCT06704178|141490266|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991172|NCT06704178|141490266|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991173|NCT06704178|141490266|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991174|NCT06704178|141490266|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991175|NCT06704178|141490266|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991176|NCT06704178|141490267|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991177|NCT06704178|141490267|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71039214|NCT01971554|141586314|SUPERIORITY_OR_OTHER||Difference in the least squares means|22.3|||||TWO_SIDED|90.0|6.2|38.4|||||A cLDA model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.|||38.4|6.2|
70991178|NCT06704178|141490267|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991179|NCT06704178|141490267|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991180|NCT06704178|141490267|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71098737|NCT01368185|141705932|SUPERIORITY_OR_OTHER_LEGACY||% change SUA from baseline|4.6|STANDARD_DEVIATION|0.9|<|0.01||95.0|||||t-test, 2 sided||Percent change of month 3 SUA minus baseline SUA.|Comparison between Month 3 and Baseline||||<0.01
71098738|NCT01368185|141705933|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||McNemar|||||||<0.0001
71098739|NCT01368185|141705934|SUPERIORITY_OR_OTHER_LEGACY||% change DBP from Baseline|-7.1|STANDARD_DEVIATION|0.4|<|0.01||95.0|||||t-test, 2 sided||Percent change of month 3 DBP minus baseline DBP (n=1239).|Comparison between Month 3 and Baseline||||<0.01
71098740|NCT01368185|141705935|SUPERIORITY_OR_OTHER_LEGACY||% change SBP from Baseline|-9.1|STANDARD_DEVIATION|0.3|<|0.01||95.0|||||t-test, 2 sided||Percent change of month 3 SBP minus baseline SBP (n=1245).|Comparison between Month 3 and Baseline||||<0.01
71098741|NCT03636269|141705936|SUPERIORITY||Odds Ratio (OR)|1.61||||0.02|TWO_SIDED|95.0|1.08|2.41|||Cui, Hung, Wang|||||2.41|1.08|0.020
71098742|NCT03636269|141705937|SUPERIORITY||Odds Ratio (OR)|1.77||||0.01|TWO_SIDED|95.0|1.14|2.74|||Cui, Hung, Wang|||||2.74|1.14|0.010
71098743|NCT03636269|141705938|SUPERIORITY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|1.29||0.171|TWO_SIDED|95.0|-4.3|0.8|||ANCOVA|||||0.8|-4.3|0.171
71098744|NCT03636269|141705939|SUPERIORITY||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.35||0.002|TWO_SIDED|95.0|-1.7|-0.4|||ANCOVA|||||-0.4|-1.7|0.002
71098745|NCT01429623|141706015|SUPERIORITY||Odds Ratio (OR)|1.55|||<|0.16|TWO_SIDED|95.0|0.74|3.25|||Log Rank|||||3.25|0.74|<0.16
71098746|NCT01429623|141706016|SUPERIORITY||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|0.24|<|0.61|TWO_SIDED||||||Mixed Models Analysis|||||||<0.61
71098747|NCT01429623|141706017|SUPERIORITY||Mean Difference (Net)|-0.066|STANDARD_ERROR_OF_MEAN|0.085|<|0.32|TWO_SIDED||||||Mixed Models Analysis|||||||<0.32
71098748|NCT01429623|141706018|SUPERIORITY||Mean Difference (Net)|0.79|STANDARD_ERROR_OF_MEAN|1.17|<|0.97|TWO_SIDED||||||Mixed Models Analysis|||||||<0.97
71098749|NCT00793611|141706029|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.07|||||||t-test, 2 sided|19 degrees of freedom||ITT between group differences in change scores compared for behavioral therapy and hypnotherapy groups. Power analysis: This is a pilot study underpowered find between group differences based on our power analysis(a 20% difference between groups would require 88 women, assuming 80% power and α=0.05 based on Freeman's study cited later). The purpose of this pilot study is to evaluate the feasibility of the larger study and determine the appropriate control intervention and outcomes||||.07
71098750|NCT00793611|141706030|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||t-test, 2 sided|||intent to treat.||||.17
71098751|NCT00793611|141706031|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|||intent to treat||||.009
71098752|NCT03757715|141706039|SUPERIORITY|||||||0.16|||||||t-test, 1 sided|||||||0.16
71098753|NCT03757715|141706040|SUPERIORITY|||||||0.42|||||||t-test, 1 sided|||||||0.42
71098754|NCT03156621|141706041|SUPERIORITY||Least squares (LS) mean difference|-35.6|STANDARD_ERROR_OF_MEAN|7.8|<|0.0001|TWO_SIDED|95.0|-51.2|-19.9||P-value taken from MMRM (mixed-effect model with repeated measures) analysis|MMRM||p-value vs Placebo|||-19.9|-51.2|<0.0001
71098755|NCT03156621|141706042|SUPERIORITY||Least squares (LS) mean difference|-29.8|STANDARD_ERROR_OF_MEAN|6.3|<|0.0001|TWO_SIDED|95.0|-42.3|-17.3||p-value taken from MMRM (mixed-effect model with repeated measures) analysis|MMRM|||||-17.3|-42.3|< 0.0001
71098756|NCT03156621|141706043|SUPERIORITY||Least squares (LS) mean difference|-32.9|STANDARD_ERROR_OF_MEAN|7.4|<|0.0001|TWO_SIDED|95.0|-47.6|-18.2||P-value taken from MMRM (mixed-effect model with repeated measures) analysis|MMRM|||||-18.2|-47.6|< 0.0001
71098757|NCT03156621|141706044|SUPERIORITY||Least squares (LS) mean difference|-26.5|STANDARD_DEVIATION|6.2|<|0.0001|TWO_SIDED|95.0|-38.9|-14.0||P-value taken from MMRM (mixed-effect model with repeated measures) analysis.|MMRM|||||-14.0|-38.9|< 0.0001
71098758|NCT03156621|141706045|SUPERIORITY||Odds Ratio, log|12.2|||=|0.0004|TWO_SIDED|95.0|3.1|48.8|||Regression, Logistic|||||48.8|3.1|= 0.0004
71098759|NCT03156621|141706046|SUPERIORITY||Odds Ratio, log|36.5|||=|0.001|TWO_SIDED|95.0|4.3|308.9|||Regression, Logistic|||||308.9|4.3|= 0.0010
71098760|NCT03156621|141706047|SUPERIORITY||Mean Difference (Final Values)|-28.4|STANDARD_DEVIATION|6.7|<|0.0001|TWO_SIDED|95.0|-41.5|-15.2|||Regression model|||||-15.2|-41.5|< 0.0001
71098761|NCT03156621|141706048|SUPERIORITY||Odds Ratio (OR)|17.7|||=|0.0017|TWO_SIDED|95.0|3.3||Maximum likelihood estimate does not exist||Exact Conditional Logistic Regression||||||3.3|= 0.0017
71098762|NCT03156621|141706049|SUPERIORITY||Least squares (LS) mean difference|3.6|STANDARD_ERROR_OF_MEAN|3.8|=|0.3541|TWO_SIDED|95.0|-4.1|11.3||P-value taken from MMRM (mixed-effect model with repeated measures) analysis.|MMRM|||||11.3|-4.1|= 0.3541
71098763|NCT03156621|141706050|SUPERIORITY||Mean Difference (Final Values)|-11.3|STANDARD_ERROR_OF_MEAN|7.1|||TWO_SIDED|95.0|-25.2|2.6||||||||2.6|-25.2|
71098764|NCT03156621|141706051|SUPERIORITY||Least squares (LS) mean difference|3.6|STANDARD_DEVIATION|3.6|||TWO_SIDED|95.0|-3.6|10.7||||||||10.7|-3.6|
71098765|NCT03156621|141706052|SUPERIORITY||Least squares (LS) mean difference|-35.6|STANDARD_ERROR_OF_MEAN|7.8|||TWO_SIDED|95.0|-51.2|-19.9||||||||-19.9|-51.2|
71098766|NCT03156621|141706053|SUPERIORITY||Least squares (LS) mean difference|-29.8|STANDARD_ERROR_OF_MEAN|6.3|||TWO_SIDED|95.0|-43.3|-17.3||||||||-17.3|-43.3|
71098767|NCT03156621|141706054|SUPERIORITY||Least squares (LS) mean difference|-32.9|STANDARD_ERROR_OF_MEAN|7.4|||TWO_SIDED|95.0|-47.6|-18.2||||||||-18.2|-47.6|
70991181|NCT06704178|141490267|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991182|NCT06704178|141490268|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71098768|NCT03156621|141706055|SUPERIORITY||Least squares (LS) mean difference|-26.5|STANDARD_ERROR_OF_MEAN|6.2|||TWO_SIDED|95.0|-28.9|-14.0||||||||-14.0|-28.9|
71098769|NCT03156621|141706056|SUPERIORITY||Mean Difference (Final Values)|-28.4|STANDARD_ERROR_OF_MEAN|6.7|||TWO_SIDED|95.0|-41.5|-15.2||||||||-15.2|-41.5|
70991183|NCT06704178|141490268|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71098770|NCT03156621|141706057|SUPERIORITY||Least squares (LS) mean difference|3.6|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-4.1|11.3||||||||11.3|-4.1|
71098771|NCT03156621|141706058|SUPERIORITY||Mean Difference (Final Values)|-11.3|STANDARD_ERROR_OF_MEAN|7.1|||TWO_SIDED|95.0|-25.2|2.6||||||||2.6|-25.2|
70991184|NCT06704178|141490268|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991185|NCT06704178|141490268|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991186|NCT06704178|141490268|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991187|NCT06704178|141490268|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991188|NCT06704178|141490269|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991189|NCT06704178|141490269|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71098772|NCT03156621|141706059|SUPERIORITY||Least squares (LS) mean difference|3.6|STANDARD_ERROR_OF_MEAN|3.6|||TWO_SIDED|95.0|-3.6|10.7||||||||10.7|-3.6|
71098773|NCT03156621|141706060|SUPERIORITY||Odds Ratio (OR)|12.2|||||TWO_SIDED|95.0|3.1|48.8||||||≥15% reduction||48.8|3.1|
71098774|NCT03156621|141706060|SUPERIORITY|≥ 30% reduction|Odds Ratio (OR)|36.5|||||TWO_SIDED|95.0|4.3|308.9||||||||308.9|4.3|
70991190|NCT06704178|141490269|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991191|NCT06704178|141490269|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991192|NCT06704178|141490269|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991193|NCT06704178|141490269|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71098775|NCT03156621|141706060|SUPERIORITY||Odds Ratio (OR)|17.7|||||TWO_SIDED|95.0|3.3||Maximum likelihood estimate does not exist|||||≥ 50% reduction|||3.3|
71098776|NCT03156621|141706061|SUPERIORITY||Least squares (LS) mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.6|-0.1||||||||-0.1|-0.6|
71098777|NCT04299425|141706067|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
71098778|NCT04299425|141706068|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
71098779|NCT04299425|141706070|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
71098780|NCT04299425|141706071|SUPERIORITY|||||||0.36|||||||Chi-squared|||||||0.36
71098781|NCT01657500|141706082|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|See above|||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Main outcome measure was endothelial cell loss at 6 months after EK. Sample size and statistical power calculations for testing equivalence of means within 10% range were performed at 80% power/0.025 level of significance. 20% variability was assumed. 6-month endothelial cell loss) should not differ significantly for surgeon-prepared versus eye bank-prepared tissue. Assuming pairs of corneas matched by pt. diagnosis and other characteristics, the required sample size was 34 donor pairs.||||< 0.05
71098782|NCT06083493|141706095|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
71098783|NCT06083493|141706096|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.20
71098784|NCT00449007|141706159|SUPERIORITY||Mean Difference (Final Values)|4.5||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"Difference between 6 months and baseline for Bupropion treated group.~Due to the low number of participants, the results are unreliable."||||1.0
71098785|NCT01452789|141706192|SUPERIORITY||||||<|0.05|||||||van Elteren|||||||<0.05
71098786|NCT01452789|141706193|SUPERIORITY||||||<|0.05|||||||van Elteren|||||||<0.05
71098787|NCT01452789|141706194|SUPERIORITY||||||<|0.05|||||||Cochran-Mantel-Haenszel|||||||<0.05
71098788|NCT00066170|141706196|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Dunnett's|||||||<0.001
71098789|NCT00066170|141706196|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Dunnett's|||||||<0.001
71098790|NCT00098293|141706197|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was greater than (\>) -10%.|Difference in Percentage|-3.0|||||ONE_SIDED|97.5|-9.5|||||||Less than 400 copies/mL: Treatment difference in percentages stratified by randomization strata (screening viral load and geographic region) was presented along with the lower bound of the 1-sided 97.5% confidence interval (CI) based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|||-9.5|
71098791|NCT00098293|141706197|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was \> -10%.|Difference in Percentage|-4.2|||||ONE_SIDED|97.5|-10.9|||||||Less than 50 copies/mL: Treatment difference in percentages stratified by randomization strata (screening viral load and geographic region) was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|||-10.9|
70991194|NCT06704178|141490270|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991195|NCT06704178|141490270|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991196|NCT06704178|141490270|SUPERIORITY|||||||0.3682||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.3682
70991197|NCT06704178|141490270|SUPERIORITY|||||||0.6098||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.6098
70991198|NCT06704178|141490270|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991199|NCT06704178|141490270|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991200|NCT06704178|141490271|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991201|NCT06704178|141490271|SUPERIORITY|||||||0.5691||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.5691
70991202|NCT06704178|141490271|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991203|NCT06704178|141490271|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991204|NCT06704178|141490271|SUPERIORITY|||||||0.6983||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.6983
70991205|NCT06704178|141490271|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991206|NCT06704178|141490272|SUPERIORITY|||||||0.819||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.819
70991207|NCT06704178|141490272|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991208|NCT06704178|141490272|SUPERIORITY|||||||0.5749||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.5749
70991209|NCT06704178|141490272|SUPERIORITY|||||||0.4873||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.4873
70991210|NCT06704178|141490272|SUPERIORITY|||||||0.9998||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9998
70991211|NCT06704178|141490272|SUPERIORITY|||||||0.819||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.819
70991212|NCT06704178|141490273|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991213|NCT06704178|141490273|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991214|NCT06704178|141490273|SUPERIORITY|||||||0.8495||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.8495
70991215|NCT06704178|141490273|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis.||||||>0.9999
70991216|NCT06704178|141490273|SUPERIORITY|||||||0.1951||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.1951
70991217|NCT06704178|141490273|SUPERIORITY|||||||0.0806||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis.||||||0.0806
70991218|NCT06704178|141490274|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991219|NCT06704178|141490274|SUPERIORITY|||||||0.6983||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.6983
70991220|NCT06704178|141490274|SUPERIORITY|||||||0.1062||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.1062
70991221|NCT06704178|141490274|SUPERIORITY|||||||0.0333||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0333
70991222|NCT06704178|141490274|SUPERIORITY|||||||0.0734||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0734
70991223|NCT06704178|141490274|SUPERIORITY|||||||0.0219||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0219
70991224|NCT06704178|141490275|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991225|NCT06704178|141490275|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991226|NCT06704178|141490275|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991227|NCT06704178|141490275|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991228|NCT06704178|141490275|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991229|NCT06704178|141490275|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991230|NCT06704178|141490276|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991231|NCT06704178|141490276|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991232|NCT06704178|141490276|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991233|NCT06704178|141490276|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991234|NCT06704178|141490276|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991235|NCT06704178|141490276|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991236|NCT06704178|141490277|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991237|NCT06704178|141490277|SUPERIORITY|||||||0.982||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.982
70991238|NCT06704178|141490277|SUPERIORITY|||||||0.091||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.091
70991239|NCT06704178|141490277|SUPERIORITY|||||||0.4449||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.4449
70991240|NCT06704178|141490277|SUPERIORITY|||||||0.0204||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0204
70991241|NCT06704178|141490277|SUPERIORITY|||||||0.0256||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0256
70991242|NCT06704178|141490278|SUPERIORITY|||||||0.9821||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9821
70991243|NCT06704178|141490278|SUPERIORITY|||||||0.0403||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0403
70991244|NCT06704178|141490278|SUPERIORITY|||||||0.0638||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0638
70991245|NCT06704178|141490278|SUPERIORITY|||||||0.7195||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.7195
70991246|NCT06704178|141490278|SUPERIORITY|||||||0.1856||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.1856
70991247|NCT06704178|141490278|SUPERIORITY|||||||0.1222||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.1222
70991248|NCT06704178|141490279|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991249|NCT06704178|141490279|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991250|NCT06704178|141490279|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within group analysis only.||||||>0.9999
71039215|NCT01971554|141586314|SUPERIORITY_OR_OTHER||Difference in the least squares means|30.6|||||TWO_SIDED|90.0|17.4|43.8|||||A cLDA model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.|||43.8|17.4|
70991251|NCT06704178|141490279|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991252|NCT06704178|141490279|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991253|NCT06704178|141490279|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991254|NCT06704178|141490280|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991255|NCT06704178|141490280|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991256|NCT06704178|141490280|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991257|NCT06704178|141490280|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991258|NCT06704178|141490280|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991259|NCT06704178|141490280|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991260|NCT06704178|141490281|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991261|NCT06704178|141490281|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991262|NCT06704178|141490281|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991263|NCT06704178|141490281|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991264|NCT06704178|141490281|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991265|NCT06704178|141490281|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991266|NCT06704178|141490282|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991267|NCT06704178|141490282|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991268|NCT06704178|141490282|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991269|NCT06704178|141490282|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991270|NCT06704178|141490282|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991271|NCT06704178|141490282|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991272|NCT06704178|141490283|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991273|NCT06704178|141490283|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991274|NCT06704178|141490283|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991275|NCT06704178|141490283|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991276|NCT06704178|141490283|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991277|NCT06704178|141490283|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991278|NCT06704178|141490284|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991279|NCT06704178|141490284|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991280|NCT06704178|141490284|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991281|NCT06704178|141490284|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991282|NCT06704178|141490284|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991283|NCT06704178|141490284|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991284|NCT06704178|141490285|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991285|NCT06704178|141490285|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991286|NCT06704178|141490285|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991287|NCT06704178|141490285|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71039216|NCT01971554|141586314|SUPERIORITY_OR_OTHER||Difference in the least squares means|48.8|||||TWO_SIDED|90.0|35.6|62.0|||||A cLDA model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.|||62.0|35.6|
71039217|NCT01426854|141586315|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
70991288|NCT06704178|141490285|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70923074|NCT02697136|141337209|OTHER|Linear mixed model to test for superiority and non-inferiority. Equivalence was defined as a difference of less than 6.7% in MVWA, based on a pilot study.|Difference in LS Means|0.7||||0.217|TWO_SIDED|95.0|-0.4|1.8|||Mixed Models Analysis|||||1.8|-0.4|0.217
70923075|NCT02697136|141337210|OTHER|Linear mixed model to test for superiority and non-inferiority. Equivalence was defined as a difference of less than 6.7% in MVWA, based on a pilot study.|Difference in LS Means|-0.2||||0.832|TWO_SIDED|95.0|-1.6|1.3|||Mixed Models Analysis|||||1.3|-1.6|0.832
70923076|NCT01095796|141337213|NON_INFERIORITY_OR_EQUIVALENCE|A total of 700 HIV-1 infected participants, randomized in a 1:1 ratio to 2 groups would achieve at least 95% power to establish noninferiority in Week 48 response (HIV-1 RNA \< 50 copies/mL per the FDA-defined snapshot analysis) rate difference between the 2 groups. For sample size and power computation, it was assumed that both treatment groups have a response rate of 0.795, a noninferiority margin of 0.12, and that the significance level of the test is at a one-sided, 0.025 level.|Difference in response rates|3.6|||||TWO_SIDED|95.2|-1.6|8.8|||||To preserve the overall alpha level: 0.05, accounting for 2 interim analyses for Independent Data Monitoring Committee meetings, the 95.2% CI was computed using normal approximation stratified by baseline HIV-1 RNA (≤ 100,000 or \> 100,000 copies/mL).|The null hypothesis was that the percentage of participants achieving HIV-1 RNA \< 50 copies/mL (as defined by the snapshot analysis algorithm) at Week 48 in the Stribild group is at least 12% worse than the response rate in the Atripla group; the alternative hypothesis was that the response rate in the Stribild group is less than 12% worse than that in the Atripla Group.||8.8|-1.6|
70923077|NCT04349072|141337262|SUPERIORITY||Proportion Difference|58.93|||<|0.0001|TWO_SIDED|95.0|43.989|73.868|||Cochran-Mantel-Haenszel|||||73.868|43.989|<0.0001
70923078|NCT04349072|141337263|SUPERIORITY||Proportion Difference|41.07|||<|0.0001|TWO_SIDED|95.0|24.481|57.662|||Cochran-Mantel-Haenszel|||||57.662|24.481|<0.0001
70923079|NCT04349072|141337264|SUPERIORITY||Leat Square Mean of Treatment Difference|9.45|||<|0.0001|TWO_SIDED|95.0|4.868|14.041|||Mixed Models Analysis|Mixed model with repeated measure (MMRM)||||14.041|4.868|<0.0001
70991289|NCT06704178|141490285|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991290|NCT06704178|141490286|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991291|NCT06704178|141490286|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991292|NCT06704178|141490286|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70923080|NCT04349072|141337265|SUPERIORITY||Mean Ratio|0.33|||<|0.0001|TWO_SIDED|95.0|0.266|0.421|||Mixed Models Analysis|Mixed model with repeated measure (MMRM)||||0.421|0.266|<0.0001
70923081|NCT04349072|141337266|SUPERIORITY||Mean Ratio|0.53|||<|0.0001|TWO_SIDED|95.0|0.406|0.7|||Mixed Models Analysis|Mixed model with repeated measure (MMRM)||||0.700|0.406|<0.0001
70923082|NCT04349072|141337267|SUPERIORITY||Leat Square Mean of Treatment Difference|-37.2|||<|0.0001|TWO_SIDED|95.0|-48.08|-26.24|||ANCOVA|||||-26.24|-48.08|<0.0001
70923083|NCT02119650|141337357|OTHER||Hazard Ratio (HR)|0.877||||0.7562|TWO_SIDED|80.0|0.509|1.51|||Log Rank|The 2-sided p-value was calculated based on the log-rank test and stratified by modified Glasgow Prognostic Score (mGPS).||||1.51|0.509|0.7562
70923084|NCT04924062|141337389|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.51|1.08|||||HR=Arm A/Arm B|||1.08|0.51|
70923085|NCT04924062|141337390|OTHER||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.58|1.19|||||HR=Arm A/Arm B|||1.19|0.58|
70923086|NCT04924062|141337391|OTHER||Difference in Percentages|7.1|||||TWO_SIDED|95.0|-7.5|21.6|||||Difference=Arm A minus Arm B|||21.6|-7.5|
70991293|NCT06704178|141490286|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991294|NCT06704178|141490286|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991295|NCT06704178|141490286|SUPERIORITY|||||||0.982||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.982
70991296|NCT06704178|141490287|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991297|NCT06704178|141490287|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991298|NCT06704178|141490287|SUPERIORITY||||||>|0.9999||||||Month 3 vs Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991299|NCT06704178|141490287|SUPERIORITY||||||>|0.9999||||||Month 4 vs Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991300|NCT06704178|141490287|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991301|NCT06704178|141490287|SUPERIORITY||||||>|0.9999||||||Month 6 vs Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991302|NCT06704178|141490288|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991303|NCT06704178|141490288|SUPERIORITY|||||||0.9951||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9951
70991304|NCT06704178|141490288|SUPERIORITY|||||||0.999||||||Month 3 versus Baseline|t-test, 2 sided|Within-group analysis only.||||||0.999
70991305|NCT06704178|141490288|SUPERIORITY|||||||0.9913||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9913
70991306|NCT06704178|141490288|SUPERIORITY|||||||0.4517||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.4517
70991307|NCT06704178|141490288|SUPERIORITY|||||||0.8187||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.8187
70991308|NCT06704178|141490289|SUPERIORITY|||||||0.998||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.998
70991309|NCT06704178|141490289|SUPERIORITY|||||||0.9591||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9591
70991310|NCT06704178|141490289|SUPERIORITY|||||||0.9994||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9994
70991311|NCT06704178|141490289|SUPERIORITY|||||||0.9936||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9936
70991312|NCT06704178|141490289|SUPERIORITY|||||||0.8526||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.8526
70991313|NCT06704178|141490289|SUPERIORITY|||||||0.4375||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.4375
70991314|NCT06704178|141490290|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991315|NCT06704178|141490290|SUPERIORITY|||||||0.7477||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis.||||||0.7477
70991316|NCT06704178|141490290|SUPERIORITY|||||||0.297||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.297
71039218|NCT03505151|141586326|OTHER||Ratio T/R|44.63|STANDARD_ERROR_OF_MEAN|36.9||||90.0|32.62|61.06|||||Standard Error of the mean is actually Intra-individual geometric coefficient of variation (gCV) of the mean|Absolute bioavailability was evaluated using an Analysis of variance model (ANOVA) on BI 409306 AUC0-inf versus 0.1 mg BI 409306 C-13/N-15 i.v. This model included effects accounting for the following sources of variation: 'subjects' and 'formulation'. The effect 'subjects' was considered as random, whereas 'formulation' was considered as fixed. The dose normalised PK endpoints were log transformed (natural logarithm) prior to fitting the ANOVA model.||61.06|32.62|
71098792|NCT00098293|141706198|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was \> -10%.|Difference in Percentage|-4.1|||||ONE_SIDED|97.5|-10.5|||||||Less than 400 copies/mL: Treatment difference in percentage stratified by randomization strata (screening viral load and geographic region) was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|||-10.5|
71098793|NCT00098293|141706198|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was \> -10%.|Difference in Percentage|-4.4|||||ONE_SIDED|97.5|-11.2|||||||Less than 50 copies/mL: Treatment difference in percentage stratified by randomization strata (screening viral load and geographic region) was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|||-11.2|
71098794|NCT00098293|141706199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.4485|TWO_SIDED|95.0|0.64|1.22|||Regression, Logistic|||Less than 400 copies/mL: Two-sided 95% CI was presented for the odds ratio between treatment groups. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), geographic region (Northern or Southern Hemisphere) as covariates was used. Odds ratio \> 1 would favor maraviroc.||1.22|0.64|0.4485
71098795|NCT00098293|141706199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.2724|TWO_SIDED|95.0|0.61|1.15|||Regression, Logistic|||Less than 50 copies/mL: Two-sided 95% CI was presented for the odds ratio between treatment groups. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), geographic region (Northern or Southern Hemisphere) as covariates were used. Odds ratio \> 1 would favor maraviroc.||1.15|0.61|0.2724
71098796|NCT00098293|141706200|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.3943|TWO_SIDED|95.0|0.65|1.19|||Regression, Logistic|||Less than 400 copies/mL: Two-sided 95% CI was presented for the odds ratio between treatment groups. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), geographic region (Northern or Southern Hemisphere) as covariates were used. Odds ratio \> 1 would favor maraviroc.||1.19|0.65|0.3943
70991317|NCT06704178|141490290|SUPERIORITY|||||||0.3503||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.3503
70991318|NCT06704178|141490290|SUPERIORITY|||||||0.297||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.297
70991319|NCT06704178|141490290|SUPERIORITY|||||||0.4449||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.4449
70991320|NCT06704178|141490291|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991321|NCT06704178|141490291|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991322|NCT06704178|141490291|SUPERIORITY|||||||0.9188||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9188
70991323|NCT06704178|141490291|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991324|NCT06704178|141490291|SUPERIORITY|||||||0.3503||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.3503
70991325|NCT06704178|141490291|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
70991326|NCT02922634|141490325|SUPERIORITY|||||||0.508|||||||Wilcoxon (Mann-Whitney)|||||||0.508
70991327|NCT02922634|141490326|SUPERIORITY|||||||0.72||||||The chi-squared test for both males and females with and without delirium.|Chi-squared|||||||0.720
70991328|NCT02922634|141490327|SUPERIORITY|||||||0.025|||||||Wilcoxon (Mann-Whitney)|||||||0.025
70991329|NCT02922634|141490328|SUPERIORITY|||||||0.48|||||||Chi-squared|||||||0.480
70991330|NCT02922634|141490329|SUPERIORITY|||||||0.028|||||||Chi-squared|||||||0.028
70991331|NCT02922634|141490330|SUPERIORITY|||||||0.007|||||||Chi-squared|||||||0.007
70991332|NCT02922634|141490331|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
70991333|NCT02922634|141490332|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
70991334|NCT02922634|141490333|SUPERIORITY|||||||0.101|||||||Chi-squared|||||||0.101
70991335|NCT02922634|141490334|SUPERIORITY|||||||0.192|||||||Chi-squared|||||||0.192
70991336|NCT02922634|141490335|SUPERIORITY|||||||0.2|||||||Chi-squared|||||||0.200
70991337|NCT02922634|141490336|SUPERIORITY|||||||0.333|||||||Wilcoxon (Mann-Whitney)|||||||0.333
70991338|NCT02922634|141490337|SUPERIORITY|||||||0.001||||||This is a chi-squared test between the FRAIL categories for participants with or without delirium.|Chi-squared|||||||0.001
70991339|NCT02922634|141490338|SUPERIORITY|||||||0.002||||||This is a chi-squared test of the categories for levels of invasiveness for participants with or without delirium.|Chi-squared|||||||0.002
70991340|NCT01694420|141490384|SUPERIORITY_OR_OTHER||||||<|0.001||||||Study data compared to data as cited in PubMed ID: 21487250|Wilcoxon (Mann-Whitney)|||||||<0.001
70991341|NCT03987919|141490387|SUPERIORITY||LS Mean Difference|-0.51|||<|0.001|TWO_SIDED|95.0|-0.64|-0.38|||Mixed Models Analysis|||||-0.38|-0.64|<0.001
70991342|NCT03987919|141490387|SUPERIORITY||LS Mean Difference|-0.6|||<|0.001|TWO_SIDED|95.0|-0.73|-0.47|||Mixed Models Analysis|||||-0.47|-0.73|<0.001
70991343|NCT03987919|141490388|SUPERIORITY||LS Mean Difference|-0.23|||<|0.001|TWO_SIDED|95.0|-0.36|-0.1|||Mixed Models Analysis|||||-0.10|-0.36|<0.001
70991344|NCT03987919|141490389|SUPERIORITY||LS Mean Difference|-1.7|||<|0.001|TWO_SIDED|95.0|-2.6|-0.7|||Mixed Models Analysis|||||-0.7|-2.6|<0.001
70991345|NCT03987919|141490389|SUPERIORITY||LS Mean Difference|-4.1|||<|0.001|TWO_SIDED|95.0|-5.0|-3.2|||Mixed Models Analysis|||||-3.2|-5.0|<0.001
70991346|NCT03987919|141490389|SUPERIORITY||LS Mean Difference|-6.2|||<|0.001|TWO_SIDED|95.0|-7.1|-5.3|||Mixed Models Analysis|||||-5.3|-7.1|<0.001
70991347|NCT03987919|141490390|SUPERIORITY||Odds Ratio (OR)|1.54||||0.023|TWO_SIDED|95.0|1.06|2.23|||Regression, Logistic|||||2.23|1.06|0.023
71039219|NCT03505151|141586327|OTHER||Ratio T/R|47.25|STANDARD_ERROR_OF_MEAN|68.8||||90.0|27.38|81.55|||||Standard Error of the mean is actually Intra-individual geometric coefficient of variation (gCV) of the mean|Ratios of BI 409306 for Cmax versus 0.1 mg BI 409306 C-13/N-15 i.v. was evaluated using ANOVA model. This model included effects accounting for the following sources of variation: 'subjects' and 'formulation'. The effect 'subjects' was considered as random, whereas 'formulation' was considered as fixed. The dose normalised PK endpoints were log transformed (natural logarithm) prior to fitting the ANOVA model.||81.55|27.38|
71098797|NCT00098293|141706200|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.1289|TWO_SIDED|95.0|0.59|1.07|||Regression, Logistic|||Less than 50 copies/mL: Two-sided 95% CI was presented for the odds ratio between treatment groups. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), geographic region (Northern or Southern Hemisphere) as covariates were used. Odds ratio \> 1 would favor maraviroc.||1.07|0.59|0.1289
71098798|NCT00098293|141706201|SUPERIORITY_OR_OTHER||LS Mean Difference|0.118|STANDARD_ERROR_OF_MEAN|0.1077||0.2741|TWO_SIDED|95.0|-0.094|0.329|||ANCOVA|||Change at week 48: P-value was calculated using Analysis of Covariance (ANCOVA) with the model including treatment arm and, as covariates, the randomization strata (screening viral load and geographic region). The difference between the treatment least squares means (LS means) adjusted for the covariates was presented in addition to 2-sided 95% CI. Negative value would favor maraviroc.||0.329|-0.094|0.2741
70991348|NCT03987919|141490390|SUPERIORITY||Odds Ratio (OR)|2.14|||<|0.001|TWO_SIDED|95.0|1.44|3.17|||Regression, Logistic|||||3.17|1.44|<0.001
70991349|NCT03987919|141490390|SUPERIORITY||Odds Ratio (OR)|3.03|||<|0.001|TWO_SIDED|95.0|1.97|4.66|||Regression, Logistic|||||4.66|1.97|<0.001
70991350|NCT03987919|141490391|SUPERIORITY||LS Mean Difference|-7.3||||0.001|TWO_SIDED|95.0|-11.7|-3.0|||Mixed Models Analysis|||||-3.0|-11.7|0.001
70991351|NCT03987919|141490391|SUPERIORITY||LS Mean Difference|-13.0|||<|0.001|TWO_SIDED|95.0|-17.4|-8.6|||Mixed Models Analysis|||||-8.6|-17.4|<0.001
70991352|NCT03987919|141490391|SUPERIORITY||LS Mean Difference|-14.7|||<|0.001|TWO_SIDED|95.0|-19.1|-10.3|||Mixed Models Analysis|||||-10.3|-19.1|<0.001
70991353|NCT03987919|141490393|SUPERIORITY||Odds Ratio (OR)|1.58||||0.001|TWO_SIDED|95.0|1.2|2.08|||Regression, Logistic|||||2.08|1.20|0.001
70991354|NCT03987919|141490393|SUPERIORITY||Odds Ratio (OR)|3.49|||<|0.001|TWO_SIDED|95.0|2.57|4.75|||Regression, Logistic|||||4.75|2.57|<0.001
70991355|NCT03987919|141490393|SUPERIORITY||Odds Ratio (OR)|4.6|||<|0.001|TWO_SIDED|95.0|3.32|6.38|||Regression, Logistic|||||6.38|3.32|<0.001
70991356|NCT03987919|141490394|SUPERIORITY||LS Mean Difference|-0.24||||0.084|TWO_SIDED|95.0|-0.5|0.03|||ANCOVA|||Hyperglycemia||0.03|-0.50|0.084
70991357|NCT03987919|141490394|SUPERIORITY||LS Mean Difference|-0.27||||0.05|TWO_SIDED|95.0|-0.54|0.0|||ANCOVA|||Hyperglycemia||0.00|-0.54|0.050
70991358|NCT03987919|141490394|SUPERIORITY||LS Mean Difference|-0.39||||0.005|TWO_SIDED|95.0|-0.66|-0.12|||ANCOVA|||Hyperglycemia||-0.12|-0.66|0.005
70991359|NCT03987919|141490394|SUPERIORITY||LS Mean Difference|-0.06||||0.688|TWO_SIDED|95.0|-0.33|0.22|||ANCOVA|||Hypoglycemia||0.22|-0.33|0.688
70991360|NCT03987919|141490394|SUPERIORITY||LS Mean Difference|-0.02||||0.909|TWO_SIDED|95.0|-0.29|0.26|||ANCOVA|||Hypoglycemia||0.26|-0.29|0.909
70991361|NCT03987919|141490394|SUPERIORITY||LS Mean Difference|-0.13||||0.358|TWO_SIDED|95.0|-0.4|0.15|||ANCOVA|||Hypoglycemia||0.15|-0.40|0.358
70991362|NCT03987919|141490394|SUPERIORITY||LS Mean Difference|-0.1||||0.701|TWO_SIDED|95.0|-0.62|0.41|||ANCOVA|||Total Score||0.41|-0.62|0.701
70991363|NCT03987919|141490394|SUPERIORITY||LS Mean Difference|-0.25||||0.341|TWO_SIDED|95.0|-0.78|0.27|||ANCOVA|||Total Score||0.27|-0.78|0.341
70991364|NCT03987919|141490394|SUPERIORITY||LS Mean Difference|0.26||||0.321|TWO_SIDED|95.0|-0.26|0.79|||ANCOVA|||Total Score||0.79|-0.26|0.321
70991365|NCT03987919|141490396|SUPERIORITY||Odds Ratio (OR)|1.86|||<|0.001|TWO_SIDED|95.0|1.35|2.57|||Regression, Logistic|||||2.57|1.35|<0.001
70991366|NCT03987919|141490396|SUPERIORITY||Odds Ratio (OR)|3.94|||<|0.001|TWO_SIDED|95.0|2.88|5.39|||Regression, Logistic|||||5.39|2.88|<0.001
70991367|NCT03987919|141490396|SUPERIORITY||Odds Ratio (OR)|5.1|||<|0.001|TWO_SIDED|95.0|3.73|6.97|||Regression, Logistic|||||6.97|3.73|<0.001
70991368|NCT01194804|141490397|OTHER||||||<|0.001|||||||Sign test|||||||<0.001
70991369|NCT03621943|141490402|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.87|TWO_SIDED|95.0|-6.36|5.37|||hierarchical generalized linear mixed mo|hierarchical generalized linear mixed models||Total score on the Ages and Stages Questionnaire, 3rd ed.||5.37|-6.36|0.87
70991370|NCT00948818|141490404|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.6||||0.0004|TWO_SIDED|95.0|1.51|4.47||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week APC 3 + 1 Responders.~The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data."||4.47|1.51|0.0004
70991371|NCT00948818|141490406|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.65|||<|0.0001|TWO_SIDED|95.0|2.26|5.88||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week CSBM 3 + 1 Responders.~The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data."||5.88|2.26|<0.0001
71039220|NCT01942135|141586333|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.422|||<|1e-06|TWO_SIDED|95.0|0.318|0.56||The overall Type-I error rate was persevered at 1-sided 0.025 level for the analysis of the primary endpoint PFS by the Haybittle-Peto efficacy boundary. The priori threshold for statistical significance was 0.00135.|Stratified Log Rank Test (1-sided)|The log rank test stratified by sensitivity to prior hormonal therapy and the presence of visceral metastases based on the randomization information.|Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of the palbociclib plus fulvestrant arm.|The primary hypothesis to be tested was H0: λ≥1 versus. HA: λ\<1, where λ was the palbociclib plus fulvestrant: placebo plus fulvestrant hazard ratio (HR). A HR less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Fulvestrant. The study was planned to have 90% power and control the type-I error rate at 0.025.||0.560|0.318|<0.000001
70991372|NCT00948818|141490407|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.0262|TWO_SIDED|95.0|1.04|1.91||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week Abdominal Pain Responders.~The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data."||1.91|1.04|0.0262
70923087|NCT02396199|141337439|SUPERIORITY||Proportion of participants|0.917||||0.006|ONE_SIDED|95.0|0.827|||One-sided test|Fisher Exact||Exact test, One-sided 95%, with lower limit (0.827)||||0.827|0.006
70923088|NCT02349412|141337444|SUPERIORITY||Mean Difference (Final Values)|3.23||||0.104|TWO_SIDED|95.0|-0.67|7.13|||ANCOVA|Statistical Method: Available Case ANCOVA Model adjusting for baseline FACT-G score||||7.13|-0.67|0.104
70923089|NCT02349412|141337445|SUPERIORITY||Mean Difference (Final Values)|3.12||||0.188|TWO_SIDED|95.0|-1.54|7.77|||ANCOVA|Statistical Method: Available Case ANCOVA Model adjusting for baseline FACT-G score||||7.77|-1.54|0.188
70923090|NCT02349412|141337446|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.884|TWO_SIDED|95.0|-0.94|2.09|||ANCOVA|Statistical Method: Available Case ANCOVA Model adjusting for baseline HADS-Depression score||||2.09|-0.94|0.884
70923091|NCT02349412|141337447|SUPERIORITY||Mean Difference (Final Values)|-0.81||||0.033|TWO_SIDED|95.0|-1.54|-0.07|||ANCOVA|Statistical Method: Available Case ANCOVA Model adjusting for baseline HADS-Anxiety score||||-0.07|-1.54|0.033
70991373|NCT00948818|141490408|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93|||<|0.0001|TWO_SIDED|95.0|1.4|2.66||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 6/12 Week APC + 1 Responders.~The power, adjusted for multiplicity, was expected to be 86% based on NCT00460811 (MCP-103-202) study data."||2.66|1.40|<0.0001
71098799|NCT00098293|141706201|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1162||0.3899|TWO_SIDED|95.0|-0.128|0.328|||ANCOVA|||Change at week 96: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Negative value would favor maraviroc.||0.328|-0.128|0.3899
70923092|NCT02349412|141337448|SUPERIORITY|||||||0.006|||||||Chi-squared|||||||0.006
70923093|NCT03611153|141337458|SUPERIORITY|||||||0.04|||||||ANCOVA|||||||0.040
70923094|NCT03611153|141337460|SUPERIORITY|||||||0.777|||||||t-test, 2 sided|||||||0.777
70923095|NCT03611153|141337461|SUPERIORITY|||||||0.805|||||||t-test, 2 sided|||Right atrial pressure||||0.805
70923096|NCT03611153|141337461|SUPERIORITY|||||||0.148|||||||t-test, 2 sided|||pulmonary artery systolic pressure||||0.148
70923097|NCT03611153|141337461|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||Mean pulmonary artery pressure||||0.090
70923098|NCT03611153|141337462|SUPERIORITY|||||||0.786|||||||t-test, 2 sided|||Right atrial pressure||||0.786
70923099|NCT03611153|141337462|SUPERIORITY|||||||0.796|||||||t-test, 2 sided|||Pulmonary artery systolic pressure||||0.796
70923100|NCT03611153|141337462|SUPERIORITY|||||||0.703|||||||t-test, 2 sided|||Mean pulmonary artery pressure||||0.703
70923101|NCT03611153|141337463|SUPERIORITY|||||||0.418|||||||t-test, 2 sided|||||||0.418
70923102|NCT03611153|141337464|SUPERIORITY|||||||0.669|||||||t-test, 2 sided|||||||0.669
70923103|NCT04840199|141337465|SUPERIORITY||Mean Difference (Net)|-0.031||||0.2|TWO_SIDED|95.0|-0.08|0.018||No adjustment for multiple comparisons|Regression, Linear||Treatment effect was estimated as the difference in mean change in log10 sTNFRII with randomized letermovir compared to no anti-CMV treatment from a linear regression model (0 reflects no difference between arms).|||0.018|-0.080|0.20
70923104|NCT04840199|141337466|SUPERIORITY||Risk Difference (RD)|0.172||||0.19|TWO_SIDED|95.0|-0.073|0.438||No adjustment for multiple comparisons|Chan/Zhang exact test diff. proportions||An exact 95% confidence interval around the observed difference in proportions (and the associated p-value) was constructed based on the standardized statistic and inverting two 1-sided tests (Chan-Zhang method).|||0.438|-0.073|0.19
70991374|NCT02371759|141490458|NON_INFERIORITY_OR_EQUIVALENCE|In order to detect 20% difference in intraoral anesthesia duration between healthy and diabetic participants, with 80 % statistical power at a two-tailed significance level of 0.05 using Mann Whitney U test, it was calculated that at least 24 participants must be included in each group|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||In order to detect 20% difference in intraoral anesthesia duration between healthy and diabetic participants, with 80 % statistical power at a two-tailed significance level of 0.05 using Mann Whitney U test, it was calculated that at least 24 participants must be included in each group||||<0.05
70991375|NCT02371759|141490459|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
70991376|NCT02371759|141490475|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
70991377|NCT02371759|141490476|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
70991378|NCT02371759|141490477|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
70991379|NCT02371759|141490478|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
70991380|NCT02371759|141490479|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70991381|NCT02371759|141490480|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70991382|NCT02371759|141490481|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
70991383|NCT02371759|141490482|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
70991384|NCT01515306|141490507|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Geo LS means|1.09|||||TWO_SIDED|90.0|0.93|1.29|||Mixed Models Analysis|Ratio of Geo LS mean is AUC(0-∞) of Cycle 2/Cycle 1.||||1.29|0.93|
70923105|NCT04840199|141337468|SUPERIORITY||Odds Ratio (OR)|0.91||||0.12|TWO_SIDED|95.0|0.8|1.03||No adjustment for multiple comparisons|GEE model for repeated binary outcomes|P-value is from the time and treatment group interaction in the early treatment phase.|Treatment effect was estimated as the odds ratio of weekly rate of change (slope) in odds of CMV DNA detection with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between arms).|Early treatment phase comparison||1.03|0.80|0.12
70923106|NCT04840199|141337468|SUPERIORITY||Odds Ratio (OR)|0.92||||0.009|TWO_SIDED|95.0|0.87|0.98||No adjustment for multiple comparisons|GEE model for repeated binary outcomes|P-value is from the time and treatment group interaction in the late treatment phase.|Treatment effect was estimated as the odds ratio of weekly rate of change (slope) in odds of CMV DNA detection with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between arms).|Late treatment phase comparison||0.98|0.87|0.009
70923107|NCT04840199|141337468|SUPERIORITY||Odds Ratio (OR)|1.17||||0.24|TWO_SIDED|95.0|0.9|1.53||No adjustment for multiple comparisons|GEE model for repeated binary outcomes|P-value is from the time and treatment group interaction in the post treatment phase.|Treatment effect was estimated as the odds ratio of weekly rate of change (slope) in odds of CMV DNA detection with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between arms).|Post treatment phase comparison||1.53|0.90|0.24
70923108|NCT04840199|141337471|SUPERIORITY||Mean Difference (Net)|0.0002||||0.95|TWO_SIDED|95.0|-0.0062|0.0066||No adjustment for multiple comparisons|GEE model for repeated outcomes|P-value is from the time and treatment group interaction in the early treatment phase.|Treatment effect was estimated as the difference in weekly rate of change (slope) in log10 sCD163 with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between treatment groups).|Early treatment phase comparison||0.0066|-0.0062|0.95
70923109|NCT04840199|141337471|SUPERIORITY||Mean Difference (Net)|-0.0007||||0.28|TWO_SIDED|95.0|-0.0019|0.0005||No adjustment for multiple comparisons|GEE model for repeated outcomes|P-value is from the time and treatment group interaction in the late treatment phase.|Treatment effect was estimated as the difference in weekly rate of change (slope) in log10 sCD163 with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between treatment groups).|Late treatment phase comparison||0.0005|-0.0019|0.28
70923110|NCT04840199|141337471|SUPERIORITY||Mean Difference (Net)|0.0056||||0.077|TWO_SIDED|95.0|-0.0006|0.0118||No adjustment for multiple comparisons|GEE model for repeated outcomes|P-value is from the time and treatment group interaction in the post treatment phase.|Treatment effect was estimated as the difference in weekly rate of change (slope) in log10 sCD163 with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between treatment groups).|Post treatment phase comparison||0.0118|-0.0006|0.077
70923111|NCT04840199|141337472|SUPERIORITY||Mean Difference (Net)|0.0009||||0.72|TWO_SIDED|95.0|-0.004|0.0058||No adjustment for multiple comparisons|GEE model for repeated outcomes|P-value is from the time and treatment group interaction in the early treatment phase.|Treatment effect was estimated as the difference in weekly rate of change (slope) in log10 sTNFRII with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between arms).|Early treatment phase comparison||0.0058|-0.0040|0.72
70923112|NCT04840199|141337472|SUPERIORITY||Mean Difference (Net)|-0.0009||||0.13|TWO_SIDED|95.0|-0.0022|0.0003||No adjustment for multiple comparisons|GEE model for repeated outcomes|P-value is from the time and treatment group interaction in the late treatment phase.|Treatment effect was estimated as the difference in weekly rate of change (slope) in log10 sTNFRII with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between arms).|Late treatment phase comparison||0.0003|-0.0022|0.13
70991385|NCT01515306|141490509|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Geo LS means|0.97|||||TWO_SIDED|90.0|0.83|1.13|||Mixed Models Analysis|Ratio of Geo LS mean is Cmax of Cycle 2/Cycle 1.||||1.13|0.83|
70991386|NCT02227329|141490541|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
70991387|NCT04973228|141490578|SUPERIORITY||Odds Ratio (OR)|2.79|||<|0.0001|TWO_SIDED|95.0|1.75|4.45|||Cochran-Mantel-Haenszel|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|IGA Success at Week 8||4.45|1.75|<0.0001
70991388|NCT04973228|141490579|SUPERIORITY||Odds Ratio (OR)|2.95||||0.0001|TWO_SIDED|95.0|1.68|5.19|||Cochran-Mantel-Haenszel|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|WI-NRS Success at Week 8||5.19|1.68|0.0001
70991389|NCT04973228|141490580|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0007|TWO_SIDED|95.0|1.47|4.67|||Cochran-Mantel-Haenszel|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|WI-NRS Success at Week 4||4.67|1.47|0.0007
70991390|NCT04973228|141490581|SUPERIORITY||Odds Ratio (OR)|2.74||||0.0016|TWO_SIDED|95.0|1.41|5.34|||Cochran-Mantel-Haenszel|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|WI-NRS Success at Week 2||5.34|1.41|0.0016
70991391|NCT04973228|141490582|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0002|TWO_SIDED|95.0|1.54|3.84|||Cochran-Mantel-Haenszel|Pooled by site and IGA strata with multiple imputation to handle missing data|Pooled by site and IGA strata with multiple imputation to handle missing data|IGA Success at Week 2||3.84|1.54|0.0002
70991392|NCT04973228|141490583|SUPERIORITY||Odds Ratio (OR)|3.22|||<|0.0001|TWO_SIDED|95.0|2.06|5.03|||Cochran-Mantel-Haenszel|Pooled by site and IGA strata with multiple imputation to handle missing data|Pooled by site and IGA strata with multiple imputation to handle missing data|IGA Success at Week 4||5.03|2.06|<0.0001
70991393|NCT04973228|141490584|SUPERIORITY||Odds Ratio (OR)|2.41|||<|0.0001|TWO_SIDED|95.0|1.56|3.73|||Cochran-Mantel-Haenszel|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Scaling Score of 0 at Week 8||3.73|1.56|<0.0001
70991394|NCT04973228|141490585|SUPERIORITY||Odds Ratio (OR)|3.22|||<|0.0001|TWO_SIDED|95.0|2.05|5.06|||Cochran-Mantel-Haenszel|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Erythema Score of 0 at Week 8||5.06|2.05|<0.0001
70991395|NCT04237207|141490586|NON_INFERIORITY|The primary efficacy objective is to demonstrate non-inferiority of AutoSense on the M90 processor compared to AutoSound on the Q90 processor for the AzBio sentence test in quiet mode based on a paired t-test. The primary efficacy analyses will test the null hypothesis (inferiority) that the mean of the paired differences in AzBio sentence scores in quiet mode (AutoSense on M90 - AutoSound on Q90) are less than or equal to -10 percentage points.||||||0.001|||||||t-test, 2 sided|||||||0.0010
70991396|NCT04237207|141490587|NON_INFERIORITY|The 1st secondary endpoint was to demonstrate that speech recognition in noise with AutoSense on a 301-M062 processor was no worse than speech recognition in noise with currently approved software on a Q90 processor.||||||0.001|||||||t-test, 2 sided|||||||0.0010
70991397|NCT04237207|141490588|NON_INFERIORITY|"The 2nd secondary endpoint was to demonstrate increased speech recognition in noise with the 301-M062 sound processor when comparing Omnidirectional program to AutoSense."|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70991398|NCT00488618|141490616|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.1|||<|0.0001|TWO_SIDED|95.0|-8.9|-3.3|||ANCOVA||cariprazine - placebo|||-3.3|-8.9|<0.0001
70991399|NCT00488618|141490617|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.64||||0.0001|TWO_SIDED|95.0|-0.97|-0.32|||ANCOVA||cariprazine - placebo|||-0.32|-0.97|0.0001
70991400|NCT03675737|141490631|SUPERIORITY||Hazard Ratio (HR)|0.78|||<|0.0001|TWO_SIDED|95.0|0.7|0.87||One-sided p-value based on log-rank test stratified by geographic region, Programmed Cell Death Ligand 1 (PD-L1) status (Combined Positive Score \[CPS\] \<1 versus CPS ≥1), and chemotherapy regimen with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status (CPS \<1 versus CPS ≥1), and chemotherapy regimen with small strata collapsed.|||0.87|0.70|<0.0001
70991401|NCT03675737|141490632|SUPERIORITY||Hazard Ratio (HR)|0.74|||<|0.0001|TWO_SIDED|95.0|0.65|0.84||One-sided p-value based on log-rank test stratified by geographic region and chemotherapy regimen with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region and chemotherapy regimen with small strata collapsed.|||0.84|0.65|<0.0001
70991402|NCT03675737|141490633|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.53|0.79||One-sided p-value based on log-rank test stratified by geographic region and chemotherapy regimen with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region and chemotherapy regimen with small strata collapsed.|||0.79|0.53|<0.0001
70991403|NCT03675737|141490634|SUPERIORITY||Hazard Ratio (HR)|0.76|||<|0.0001|TWO_SIDED|95.0|0.67|0.85||One-sided p-value based on log-rank test stratified by geographic region, Programmed Cell Death Ligand 1 (PD-L1) status (Combined Positive Score \[CPS\] \<1 versus CPS ≥1), and chemotherapy regimen with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status (CPS \<1 versus CPS ≥1), and chemotherapy regimen with small strata collapsed.|||0.85|0.67|<0.0001
70991404|NCT03675737|141490635|SUPERIORITY||Hazard Ratio (HR)|0.72|||<|0.0001|TWO_SIDED|95.0|0.63|0.82||One-sided p-value based on log-rank test stratified by geographic region and chemotherapy regimen with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region and chemotherapy regimen with small strata collapsed.|||0.82|0.63|<0.0001
70991405|NCT03675737|141490636|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.51|0.76||One-sided p-value based on log-rank test stratified by geographic region and chemotherapy regimen with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region and chemotherapy regimen with small strata collapsed.|||0.76|0.51|<0.0001
70991406|NCT03675737|141490637|SUPERIORITY||Difference in Percentage|9.3||||9e-05|TWO_SIDED|95.0|4.4|14.1||One-sided p-value based on Miettinen \& Nurminen method stratified by geographic region, Programmed Cell Death Ligand 1 (PD-L1) status (Combined Positive Score \[CPS\] \<1 versus CPS ≥1), and chemotherapy regimen with small strata collapsed.|Miettinen & Nurminen method||Based on Miettinen \& Nurminen method stratified by geographic region, PD-L1 status (CPS \<1 versus CPS ≥1), and chemotherapy regimen with small strata collapsed.|||14.1|4.4|0.00009
70991407|NCT03675737|141490638|SUPERIORITY||Difference in Percentage|9.5||||0.00041|TWO_SIDED|95.0|3.9|15.0||One-sided p-value based on Miettinen \& Nurminen method stratified by geographic region and chemotherapy regimen with small strata collapsed.|Miettinen & Nurminen method||Based on Miettinen \& Nurminen method stratified by geographic region and chemotherapy regimen with small strata collapsed.|||15.0|3.9|0.00041
70991408|NCT03675737|141490639|SUPERIORITY||Difference in Percentage|17.5||||2e-05|TWO_SIDED|95.0|9.3|25.5||One-sided p-value based on Miettinen \& Nurminen method stratified by geographic region and chemotherapy regimen with small strata collapsed.|Miettinen & Nurminen method||Based on Miettinen \& Nurminen method stratified by geographic region and chemotherapy regimen with small strata collapsed.|||25.5|9.3|0.00002
70991409|NCT05138783|141490645|NON_INFERIORITY|Noninferiority in distance VA was declared if upper confidence limit was less than 0.05.|Least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.004|||ONE_SIDED|95.0||0.0||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, period, and sequence) and random (subject) effects. Difference = PRECISION1 minus BIOTRUE. Sign (either negative or positive) is retained with the rounded value.|||0.00||
70991410|NCT00078559|141490650|SUPERIORITY_OR_OTHER||Proportion with acute rejection|0.1|||||TWO_SIDED|95.0|0.01|0.34|||95% Confidence Interval|Exact Binomial||||0.34|0.01|
70991411|NCT00078559|141490651|SUPERIORITY_OR_OTHER||Proportion with acute rejection|0.0|||||TWO_SIDED|95.0|0.0|0.3|||95% Confidence Interval|Exact Binomial||||0.3|0.0|
71039221|NCT01942135|141586335|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.814|||=|0.0429|TWO_SIDED|95.0|0.644|1.029||1-sided p-value from the log-rank test stratified by the presence of visceral metastases and sensitivity to prior endocrine therapy per randomization.|Stratified Log Rank Test (1-sided)|The log rank test stratified by sensitivity to prior hormonal therapy and the presence of visceral metastases based on the randomization information.|Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of palbociclib plus fulvestrant.|The primary hypothesis to be tested was H0: λ≥1 versus. HA: λ\<1, where λ was the palbociclib plus fulvestrant: placebo plus fulvestrant hazard ratio (HR). A HR less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Fulvestrant. The study was planned to have 90% power and control the type-I error rate at 0.025.||1.029|0.644|=0.0429
70991412|NCT00078559|141490652|SUPERIORITY_OR_OTHER||Proportion with acute rejection|0.0|||||TWO_SIDED|95.0|0.0|0.7|||95% Confidence Interval|Exact Binomial||||0.7|0.0|
70991413|NCT00078559|141490655|SUPERIORITY_OR_OTHER||Exact Binomial|0.0|||||TWO_SIDED|95.0|0.0|0.3|||95% Confidence Interval|Exact Binomial||||0.3|0.0|
70991414|NCT00078559|141490656|SUPERIORITY_OR_OTHER||Exact Binomial|0.0|||||TWO_SIDED|95.0|0.0|0.3|||95% Confidence Interval|Exact Binomial for all participants (n=10)||||0.3|0.0|
70991415|NCT00078559|141490657|SUPERIORITY_OR_OTHER||Exact Binomial|0.0|||||TWO_SIDED|95.0|0.0|0.4|||95% Confidence Interval|Exact Binomial for Not Withdrawn Group||||0.4|0.0|
70991416|NCT00078559|141490657|SUPERIORITY_OR_OTHER||Exact Binomial|0.0|||||TWO_SIDED|95.0|0.0|0.8|||95% Confidence Interval|Exact Binomial for Withdrawn Group||||0.8|0.0|
70991417|NCT00078559|141490658|SUPERIORITY_OR_OTHER||Exact Binomial|0.0|||||TWO_SIDED|95.0|0.0|0.4|||95% Confidence Interval|Exact Binomial for Not Withdrawn Group||||0.4|0.0|
71039222|NCT01942135|141586337|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.783||||0.0001|TWO_SIDED|95.0|1.563|5.603||The p-value was not adjusted for multiple comparisons. The priori threshold for statistical significance is 1-sided, alpha=0.025.|Exact test (1-sided)|The 1-sided p-value is from the stratified exact test.|An Odds Ratio \>1 means better response in favor of the palbociclib plus fulvestrant arm.|The exact test is testing the null hypothesis that the odds ratio of objective response rate is less than or equal to 1 vs. the alternative hypothesis that the odds ratio of objective response rate is greater than 1. An Odds Ratio \>1 means better response in favor of palbociclib plus fulvestrant arm.||5.603|1.563|0.0001
71098800|NCT00098293|141706202|SUPERIORITY_OR_OTHER||LS Mean Difference|0.111|STANDARD_ERROR_OF_MEAN|0.1002||0.2693|TWO_SIDED|95.0|-0.086|0.307|||ANCOVA|||Week 48: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Negative value would favor maraviroc.||0.307|-0.086|0.2693
70991418|NCT00078559|141490658|SUPERIORITY_OR_OTHER||Exact Binomial|0.0|||||TWO_SIDED|95.0|0.0|0.8|||95% Confidence Interval|Exact Binomial for Withdrawn Group||||0.8|0.0|
70991419|NCT03725202|141490664|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|17.1|||=|0.0019|TWO_SIDED|95.0|6.3|27.8|||Cochran-Mantel-Haenszel||Response rate difference = 15 mg Upadacitinib - Placebo|15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||27.8|6.3|=0.0019
70991420|NCT03725202|141490664|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|12.1|||=|0.0579|TWO_SIDED|95.0|-0.4|24.6|||Cochran-Mantel-Haenszel||Response rate difference = 7.5 mg Upadacitinib - Placebo|7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||24.6|-0.4|=0.0579
70991421|NCT03725202|141490665|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|20.7|||<|0.0001|TWO_SIDED|95.0|11.3|30.2|||Cochran-Mantel-Haenszel||Response rate difference = 15 mg Upadacitinib - Placebo|15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||30.2|11.3|<0.0001
70991422|NCT03725202|141490665|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|9.9|||=|0.0699|TWO_SIDED|95.0|-0.8|20.6|||Cochran-Mantel-Haenszel||Response rate difference = 7.5 mg Upadacitinib - Placebo|7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||20.6|-0.8|=0.0699
70991423|NCT03725202|141490666|SUPERIORITY|P-value is based on the van Elteren test, adjusting for the strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease)).|||||<|0.0001|||||||van Elteren test|||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||||<0.0001
70991424|NCT03725202|141490666|SUPERIORITY|P-value is based on the van Elteren test, adjusting for the strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease)).|||||<|0.0001|||||||van Elteren test|||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||||<0.0001
70991425|NCT03725202|141490667|SUPERIORITY|Treatment comparisons in the distribution of time-to-event between each upadacitinib group and the placebo are conducted using stratified log-rank test stratified by stratification factors (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease). Within each stratum, 95% CI for difference are calculated using Cox proportional hazards model with stratification factors as covariates|Cox Proportional Hazard|0.57|||=|0.0025|TWO_SIDED|95.0|0.399|0.826|||Log-rank test|||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||0.826|0.399|=0.0025
70991426|NCT03725202|141490667|SUPERIORITY|Treatment comparisons in the distribution of time-to-event between each upadacitinib group and the placebo are conducted using stratified log-rank test stratified by stratification factors (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease). Within each stratum, 95% CI for difference are calculated using Cox proportional hazards model with stratification factors as covariates|Cox Proportional Hazard|0.75|||=|0.1778|TWO_SIDED|95.0|0.499|1.136|||Log-rank test|||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||1.136|0.499|=0.1778
70991427|NCT03725202|141490668|SUPERIORITY|The point estimate of flare rate at Week 52 from the Kaplan-Meier estimate for each stratum is used to derive the stratified disease flare rate. P-value, and 95% CI for the odds ratio between each upadacitinib group and placebo is also provided. Stratification factors (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease) were used.|Odds Ratio (OR)|0.47|||=|0.0014|TWO_SIDED|95.0|0.29|0.74|||Stratified Test for Odds Ratio|This method is described in J Immunother Cancer. 2021 Nov;9(11):e003323. doi: 10.1136/jitc-2021-003323.||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||0.74|0.29|=0.0014
71098801|NCT00098293|141706202|SUPERIORITY_OR_OTHER||LS Mean Difference|0.089|STANDARD_ERROR_OF_MEAN|0.1121||0.427|TWO_SIDED|95.0|-0.131|0.309|||ANCOVA|||Week 96: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Negative value would favor maraviroc.||0.309|-0.131|0.4270
70991428|NCT03725202|141490668|SUPERIORITY|The point estimate of flare rate at Week 52 from the Kaplan-Meier estimate for each stratum is used to derive the stratified disease flare rate. P-value, and 95% CI for the odds ratio between each upadacitinib group and placebo is also provided. Stratification factors (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease) were used.|Odds Ratio (OR)|0.6|||=|0.0633|TWO_SIDED|95.0|0.35|1.03|||Stratified Test for Odds Ratio|This method is described in J Immunother Cancer. 2021 Nov;9(11):e003323. doi: 10.1136/jitc-2021-003323.||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||1.03|0.35|=0.0633
70991429|NCT03725202|141490669|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|30.3|||<|0.0001|TWO_SIDED|95.0|20.4|40.2|||Cochran-Mantel-Haenszel|||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||40.2|20.4|<0.0001
70991430|NCT03725202|141490669|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|23.5|||<|0.0001|TWO_SIDED|95.0|11.7|35.3|||Cochran-Mantel-Haenszel|||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||35.3|11.7|<0.0001
70991431|NCT03725202|141490670|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|20.8|||=|0.0002|TWO_SIDED|95.0|9.7|31.9|||Cochran-Mantel-Haenszel|||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||31.9|9.7|=0.0002
70991432|NCT03725202|141490670|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|3.2|||=|0.6276|TWO_SIDED|95.0|-9.6|16.0|||Cochran-Mantel-Haenszel|||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||16.0|-9.6|=0.6276
70991433|NCT03725202|141490671|SUPERIORITY|The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone \>30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.|LS Mean Difference|3.7526|STANDARD_ERROR_OF_MEAN|1.1981|=|0.0019|TWO_SIDED|95.0|1.3932|6.1119|||Mixed-Effect Model Repeat Measurement||Difference = 15 mg Upadacitinib - Placebo|15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||6.1119|1.3932|=0.0019
70991434|NCT03725202|141490671|SUPERIORITY|The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone \>30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.|LS Mean Difference|2.6094|STANDARD_ERROR_OF_MEAN|1.4185|=|0.067|TWO_SIDED|95.0|-0.1841|5.4028|||Mixed-Effect Model Repeat Measurement||Difference = 7.5 mg Upadacitinib - Placebo|7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||5.4028|-0.1841|=0.0670
70991435|NCT03725202|141490672|SUPERIORITY|Comparisons between each upadacitinib treatment group and the placebo group are carried out using Poisson regression model with stratification factors as covariates and log(duration of study participation in years) as an offset. Robust standard error is used in inference.|Rate Ratio|0.6||||0.001|TWO_SIDED|95.0|0.4|0.8|||Poisson regression model|||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||0.8|0.4|0.0010
70991436|NCT03725202|141490672|SUPERIORITY|Comparisons between each upadacitinib treatment group and the placebo group are carried out using Poisson regression model with stratification factors as covariates and log(duration of study participation in years) as an offset. Robust standard error is used in inference.|Rate Ratio|0.8|||=|0.2722|TWO_SIDED|95.0|0.6|1.2|||Poisson regression model|||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||1.2|0.6|=0.2722
70991437|NCT03725202|141490673|SUPERIORITY|The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone \>30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.|LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|1.38|=|0.0036|TWO_SIDED|95.0|1.33|6.76|||Mixed-Effect Model Repeat Measurement||Difference = 15 mg Upadacitinib -Placebo|15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||6.76|1.33|=0.0036
70991438|NCT03725202|141490673|SUPERIORITY|The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone \>30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.|LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|1.63|=|0.0338|TWO_SIDED|95.0|0.27|6.7|||Mixed-Effect Model Repeat Measurement||Difference = 7.5 mg Upadacitinib -Placebo|7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||6.70|0.27|=0.0338
70991439|NCT03725202|141490674|SUPERIORITY|The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone \>30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.|LS Mean Difference|2.7325|STANDARD_ERROR_OF_MEAN|2.9635|=|0.3573|TWO_SIDED|95.0|-3.102|8.567|||Mixed-Effect Model Repeat Measurement||Difference = 15 mg Upadacitinib -Placebo|15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||8.5670|-3.1020|=0.3573
70991440|NCT03725202|141490674|SUPERIORITY|The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone \>30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.|LS Mean Difference|5.4216|STANDARD_ERROR_OF_MEAN|3.4785|=|0.1203|TWO_SIDED|95.0|-1.4269|12.2701|||Mixed-Effect Model Repeat Measurement||Difference = 7.5 mg Upadacitinib -Placebo|7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||12.2701|-1.4269|=0.1203
70991441|NCT03725202|141490675|SUPERIORITY|Comparisons between each upadacitinib treatment group and the placebo group are carried out using Poisson regression model with stratification factors as covariates and log(duration of study participation in years) as an offset. Robust standard error is used in inference.|Rate Ratio|1.1|||=|0.4371|TWO_SIDED|95.0|0.8|1.6|||Poisson regression model|||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||1.6|0.8|=0.4371
70991442|NCT03725202|141490675|SUPERIORITY|Comparisons between each upadacitinib treatment group and the placebo group are carried out using Poisson regression model with stratification factors as covariates and log(duration of study participation in years) as an offset. Robust standard error is used in inference.|Rate Ratio|0.9|||=|0.7749|TWO_SIDED|95.0|0.6|1.4|||Poisson regression model|||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||1.4|0.6|=0.7749
70991443|NCT01328249|141490679|OTHER|Fisher's Exact test||||||0.4422||||||Null hypothesis: The feasibility rates of Cohort 1 and Cohort 2 are same.|Fisher Exact|Exploratory analysis comparing primary feasibilities between 2 cohorts, based on Fisher's Exact test.||||||0.4422
70991444|NCT01716533|141490706|SUPERIORITY||GMC ratio|1.53||||0.5746|TWO_SIDED|95.0|0.33|7.14||P-value = two-sided p-value for HO: GMC ratio = 1 (ANOVA model, T-test), groups considered as statistically significant different if the two-sided p-value is below 0.05.|ANOVA|ANOVA model -pooled variance.|GMC ratio = GMC Sustained response Group /GMC Recurrence Group.|ELISA anti-toxin B antibody concentrations at Day 14 were compared between the Sustained response Group and Recurrence Group by using a one-way analysis of variance (ANOVA) model on the log-transformed concentration.||7.14|0.33|0.5746
71098802|NCT00098293|141706203|SUPERIORITY_OR_OTHER||LS Mean Difference|26.34|STANDARD_ERROR_OF_MEAN|9.827||0.0075|TWO_SIDED|95.0|7.04|45.63|||ANCOVA|||Change at Week 48: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, baseline CD4 count and the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Positive value would favor maraviroc.||45.63|7.04|0.0075
71098803|NCT00098293|141706203|SUPERIORITY_OR_OTHER||LS Mean Difference|35.44|STANDARD_ERROR_OF_MEAN|11.419||0.002|TWO_SIDED|95.0|13.02|57.86|||ANCOVA|||Change at Week 96: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, baseline CD4 count and the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Positive value would favor maraviroc.||57.86|13.02|0.0020
70991445|NCT01716533|141490707|SUPERIORITY|ANOVA model -pooled variance.|GMC ratio|1.65||||0.7124|TWO_SIDED|95.0|0.1|26.41||P-value = two-sided p-value for HO: GMC ratio = 1, groups considered as statistically significant different if the two-sided p-value is below 0.05.|ANOVA||GMC ratio = GMC Sustained response Group /GMC Recurrence Group.|Serum F2 C-terminal anti-toxin B antibody concentrations at Day 14 were compared between the Sustained response Group and Recurrence Group by using a one-way analysis of variance (ANOVA) model on the log-transformed concentration.||26.41|0.10|0.7124
70991446|NCT02330549|141490718|OTHER|This was a proof of concept study, and is not powered for statistical detection of differences between groups, no adjustments for multiplicity was made, or no-imputation for missing data.|LS Mean Difference|-0.2286|STANDARD_ERROR_OF_MEAN|0.195||0.2483|TWO_SIDED|95.0|-0.62|0.17||An analysis of covariance (ANCOVA) model that included treatment and presence or absence of nonalcoholic steatohepatitis (NASH) as factors, and the baseline value of Matsuda index as a covariate was used for analysis.|ANCOVA|||Change from Baseline to Week 12||0.17|-0.62|0.2483
71039223|NCT01942135|141586339|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.016|||<|0.0001|TWO_SIDED|95.0|2.046|4.565||The p-value was not adjusted for multiple comparisons. The priori threshold for statistical significance is 1-sided, alpha=0.025.|Exact test (1-sided)|The 1-sided p-value is from the stratified exact test.|An odds ratio \> 1 means better clinical benefit response in favor of palbociclib plus fulvestrant arm.|The exact test is testing the null hypothesis that the odds ratio of objective response rate is less than or equal to 1 vs. the alternative hypothesis that the odds ratio of objective response rate is greater than 1. An Odds Ratio \>1 means better response in favor of palbociclib plus fulvestrant arm.||4.565|2.046|<0.0001
71039224|NCT01942135|141586343|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.1||||0.0313|TWO_SIDED|95.0|0.3|6.0||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for Global health status/ QoL||6.0|0.3|0.0313
71039225|NCT01942135|141586343|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.4|TWO_SIDED|95.0|-1.4|3.5||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for physical functioning||3.5|-1.4|0.4000
71098804|NCT00098293|141706204|SUPERIORITY_OR_OTHER||LS Mean Difference|166.29|STANDARD_ERROR_OF_MEAN|25.04|<|0.0001|TWO_SIDED|95.0|117.13|215.46|||ANCOVA|||Change at Week 48: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, baseline CD8 count and the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Positive value would favor maraviroc.||215.46|117.13|<0.0001
71098805|NCT00098293|141706204|SUPERIORITY_OR_OTHER||LS Mean Difference|172.22|STANDARD_ERROR_OF_MEAN|25.471|<|0.0001|TWO_SIDED|95.0|122.21|222.23|||ANCOVA|||Change at Week 96: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, baseline CD8 count and the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Positive value would favor maraviroc.||222.23|122.21|<0.0001
71039226|NCT01942135|141586343|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.9||||0.2615|TWO_SIDED|95.0|-1.5|5.3||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for role functioning||5.3|-1.5|0.2615
71039227|NCT01942135|141586343|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.6||||0.0016|TWO_SIDED|95.0|1.7|7.4||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for emotional functioning||7.4|1.7|0.0016
71039228|NCT01942135|141586343|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.2||||0.365|TWO_SIDED|95.0|-1.4|3.8||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for cognitive functioning||3.8|-1.4|0.3650
70991447|NCT02330549|141490718|OTHER|This was a proof of concept study, and is not powered for statistical detection of differences between groups, no adjustments for multiplicity was made, or no-imputation for missing data.|LS Mean Difference|-0.4113|STANDARD_ERROR_OF_MEAN|0.205||0.053|TWO_SIDED|95.0|-0.83|0.01||An ANCOVA model that included treatment and presence or absence of NASH as factors, and the baseline value of Matsuda index as a covariate was used for analysis.|ANCOVA|||Change form Baseline to Week 24||0.01|-0.83|0.053
70991448|NCT02330549|141490719|OTHER|This was a proof of concept study, and is not powered for statistical detection of differences between groups, no adjustments for multiplicity was made, or no-imputation for missing data.|LS Mean Difference|-1.505|STANDARD_ERROR_OF_MEAN|2.369||0.5297|TWO_SIDED|95.0|-6.33|3.32||An ANCOVA model that included treatment and presence or absence of NASH as factors, and the baseline value of ADIPO-IR as a covariate was used for analysis.|ANCOVA|||Change from Baseline to Week 12||3.32|-6.33|0.5297
70991449|NCT02330549|141490719|OTHER|This was a proof of concept study, and is not powered for statistical detection of differences between groups, no adjustments for multiplicity was made, or no-imputation for missing data.|LS Mean Difference|3.2146|STANDARD_ERROR_OF_MEAN|2.757||0.2522|TWO_SIDED|95.0|-2.4|8.83||An ANCOVA model that included treatment and presence or absence of NASH as factors, and the baseline value of ADIPO-IR as a covariate was used for analysis.|ANCOVA|||Change from Baseline to Week 24||8.83|-2.4|0.2522
71039229|NCT01942135|141586343|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.9615|TWO_SIDED|95.0|-3.4|3.5||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for social functioning||3.5|-3.4|0.9615
71039230|NCT01942135|141586344|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5||||0.32|TWO_SIDED|95.0|-4.5|1.5||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for fatigue||1.5|-4.5|0.3200
71039231|NCT01942135|141586344|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5||||0.0369|TWO_SIDED|95.0|-4.8|-0.2||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for nausea and vomiting||-0.2|-4.8|0.0369
71039232|NCT01942135|141586344|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3||||0.0011|TWO_SIDED|95.0|-8.5|-2.1||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for pain||-2.1|-8.5|0.0011
71039233|NCT01942135|141586344|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.7699|TWO_SIDED|95.0|-3.7|2.8||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for dyspnoea||2.8|-3.7|0.7699
71039234|NCT01942135|141586344|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.2721|TWO_SIDED|95.0|-5.5|1.6||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for insomnia||1.6|-5.5|0.2721
71039235|NCT01942135|141586344|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.7334|TWO_SIDED|95.0|-4.1|2.9||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for appetite loss||2.9|-4.1|0.7334
71039236|NCT01942135|141586344|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7||||0.6491|TWO_SIDED|95.0|-2.5|3.9||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for constipation||3.9|-2.5|0.6491
71039237|NCT01942135|141586344|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.6293|TWO_SIDED|95.0|-2.8|1.7||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for diarrhoea||1.7|-2.8|0.6293
70991450|NCT00495495|141490798|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.02||||0.1126|ONE_SIDED||||||McNemar|||"Null hypothesis: there is no difference between the HealOzone and Placebo devices in the proportion of teeth with lesion progression after 1 year.~Power calculation: the study was sized to have 90% power to detect a 15% difference between treatments in the percentage of teeth with lesion progression at one year (i.e., assuming 45% for the lesions treated with the Placebo device and 30% for the lesions treated with the HealOzone device) with a sample size of 258 subjects completing the study."||||0.1126
70991451|NCT00495495|141490799|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.08||||0.9777|ONE_SIDED||||||McNemar|||||||.9777
70991452|NCT00495495|141490800|SUPERIORITY_OR_OTHER|||||||0.0416|ONE_SIDED|95.0|||||McNemar|||||||.0416
70991453|NCT00495495|141490801|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.01||||0.6585|ONE_SIDED|95.0|||||McNemar|||||||0.6585
70991454|NCT00495495|141490802|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.02||||0.7666|ONE_SIDED|95.0|||||McNemar|||||||.7666
70991455|NCT00797797|141490839|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||The responder rates between 'No Treatment Added' and 'Milnacipran Added' groups were compared using a logistic regression model.||||<0.001
70991456|NCT00797797|141490840|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-14.35|||||TWO_SIDED|95.0|-18.99|-9.71|||ANCOVA|||This parameter was analyzed using an ANCOVA model with treatment group and study center as factors and baseline value as a covariate.||-9.71|-18.99|
70991457|NCT01575197|141490841|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||Fisher Exact|||||||0.014
71039238|NCT01942135|141586344|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3||||0.8812|TWO_SIDED|95.0|-3.1|3.6||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for financial difficulties||3.6|-3.1|0.8812
70991458|NCT01575197|141490842|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Fisher Exact|||||||0.16
70991459|NCT01575197|141490843|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||t-test, 2 sided|||||||0.038
70991460|NCT01575197|141490844|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||||||0.30
70991461|NCT01290445|141490859|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.46|1.47||||||Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||1.47|0.46|
70991462|NCT01290445|141490859|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.45|1.42||||||Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||1.42|0.45|
70991463|NCT01290445|141490860|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.61|||||TWO_SIDED|95.0|0.09|4.34||||||Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||4.34|0.09|
70991464|NCT01290445|141490860|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.09|4.67||||||Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||4.67|0.09|
70991465|NCT01290445|141490861|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.5|0.96||||||Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||0.96|0.50|
70991466|NCT01290445|141490861|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.51|0.97||||||Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||0.97|0.51|
70991467|NCT01290445|141490862|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.63|1.42||||||Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||1.42|0.63|
70991468|NCT01290445|141490862|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.61|1.37||||||Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||1.37|0.61|
70991469|NCT01290445|141490863|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.37|1.16||||||Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||1.16|0.37|
70991470|NCT01290445|141490863|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.37|1.16||||||Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||1.16|0.37|
70991471|NCT01830543|141490909|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59|||<|0.001|TWO_SIDED|95.0|0.47|0.76|||Log Rank|||||0.76|0.47|<0.001
70991472|NCT01830543|141490909|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.001|TWO_SIDED|95.0|0.5|0.8|||Log Rank|||||0.8|0.5|<0.001
70991473|NCT01830543|141490910|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.234|TWO_SIDED|95.0|0.33|1.31|||Log Rank|||||1.31|0.33|0.234
70991474|NCT01830543|141490910|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.114|TWO_SIDED|95.0|0.28|1.16|||Log Rank|||||1.16|0.28|0.114
70991475|NCT01830543|141490911|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.51||||0.144|TWO_SIDED|95.0|0.2|1.28|||Log Rank|||||1.28|0.2|0.144
70991476|NCT01830543|141490911|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5||||0.134|TWO_SIDED|95.0|0.2|1.26|||Log Rank|||||1.26|0.2|0.134
70991477|NCT01830543|141490912|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61|||<|0.001|TWO_SIDED|95.0|0.47|0.8|||Log Rank|||||0.8|0.47|<0.001
70991478|NCT01830543|141490912|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.002|TWO_SIDED|95.0|0.52|0.86|||Log Rank|||||0.86|0.52|0.002
70991479|NCT01830543|141490913|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.75|TWO_SIDED|95.0|0.69|1.68|||Log Rank|||||1.68|0.69|0.75
70991480|NCT01830543|141490913|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.765|TWO_SIDED|95.0|0.59|1.48|||Log Rank|||||1.48|0.59|0.765
70991481|NCT01830543|141490914|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.523|TWO_SIDED|95.0|0.59|2.8|||Log Rank|||||2.8|0.59|0.523
70991482|NCT01830543|141490914|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.664|TWO_SIDED|95.0|0.54|2.62|||Log Rank|||||2.62|0.54|0.664
70991483|NCT01830543|141490915|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.625|TWO_SIDED|95.0|0.46|1.59|||Log Rank|||||1.59|0.46|0.625
70991484|NCT01830543|141490915|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.374|TWO_SIDED|95.0|0.4|1.42|||Log Rank|||||1.42|0.4|0.374
70991485|NCT01830543|141490916|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.891|TWO_SIDED|95.0|0.39|2.96|||Log Rank|||||2.96|0.39|0.891
71039239|NCT01942135|141586345|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.3||||0.1386|TWO_SIDED|95.0|-0.7|5.2||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for body image||5.2|-0.7|0.1386
71039240|NCT01942135|141586345|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.5235|TWO_SIDED|95.0|-3.1|1.6||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for sexual functioning||1.6|-3.1|0.5235
70991486|NCT01830543|141490916|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.36||||0.53|TWO_SIDED|95.0|0.52|3.58|||Log Rank|||||3.58|0.52|0.53
70991487|NCT01830543|141490917|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.79|TWO_SIDED|95.0|0.32|4.45|||Log Rank|||||4.45|0.32|0.79
70991488|NCT01830543|141490917|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.44||||0.574|TWO_SIDED|95.0|0.4|5.09|||Log Rank|||||5.09|0.4|0.574
70991489|NCT02059213|141490920|SUPERIORITY|||||||0.87|||||||Fisher Exact|Mid P-value||With 20 patients treated with ADT and 40 treated with ADT + palbociclib there is a 64.2% power to detect a 20% difference in proportions with a one-sided type I error of 0.10 using the mid p-value method of the Fisher's exact test.||||0.87
71039241|NCT01942135|141586345|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4||||0.6271|TWO_SIDED|95.0|-4.4|7.3||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for sexual enjoyment||7.3|-4.4|0.6271
70991490|NCT02059213|141490922|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||||||0.92
70991491|NCT02059213|141490923|SUPERIORITY|||||||0.5|||||||Fisher Exact|Mid p-value||||||0.50
70991492|NCT02059213|141490924|SUPERIORITY|||||||0.72|||||||Log Rank|||||||0.72
70991493|NCT02059213|141490925|SUPERIORITY|||||||0.76|||||||Log Rank|||||||0.76
70991494|NCT03583372|141490950|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-2.4|||||TWO_SIDED|95.0|-2.9|-2.0||||||||-2.0|-2.9|
70991495|NCT03583372|141490950|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-2.0|||||TWO_SIDED|95.0|-2.5|-1.5||||||||-1.5|-2.5|
70991496|NCT03583372|141490951|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-2.2|||||TWO_SIDED|95.0|-2.5|-1.9||||||||-1.9|-2.5|
70991497|NCT03583372|141490951|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-1.7|||||TWO_SIDED|95.0|-2.0|-1.3||||||||-1.3|-2.0|
70991498|NCT03583372|141490952|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-3.4|||||TWO_SIDED|95.0|-4.0|-2.7||||||||-2.7|-4.0|
70991499|NCT03583372|141490952|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-3.2|||||TWO_SIDED|95.0|-4.0|-2.5||||||||-2.5|-4.0|
70991500|NCT03583372|141490953|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-2.5|||||TWO_SIDED|95.0|-2.8|-2.2||||||||-2.2|-2.8|
70991501|NCT03583372|141490953|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-1.9|||||TWO_SIDED|95.0|-2.3|-1.6||||||||-1.6|-2.3|
70991502|NCT01151046|141490955|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26||||0.003|TWO_SIDED|95.0|0.11|0.63|||Log Rank|||||0.63|0.11|0.003
70991503|NCT01151046|141490955|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.41||||0.349|TWO_SIDED|95.0|0.69|2.88|||Log Rank|||||2.88|0.69|0.349
70991504|NCT05439460|141490961|OTHER|||||||0.9|||||||t-test, 2 sided|||Change in phenylephrine group||||0.9
70991505|NCT05439460|141490961|OTHER|||||||0.3||||||A p-value of \<0.05 would be considered statistically significant.|t-test, 2 sided|||Change in arginine vasopressin group||||0.3
70991506|NCT05439460|141490961|OTHER|||||||1||||||A p-value of \<0.05 would be considered statistically significant.|t-test, 2 sided|||Change in epinephrine group||||1
70991507|NCT03446651|141490962|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||||||0.56
70991508|NCT03446651|141490964|SUPERIORITY|||||||0.039|||||||t-test, 2 sided|||||||0.039
70991509|NCT03446651|141490966|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70991510|NCT03446651|141490967|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70991511|NCT02420223|141490968|SUPERIORITY|||||||0.017|||||||Regression, Logistic|||||||.017
70991512|NCT02420223|141490968|SUPERIORITY|||||||0.337|||||||Regression, Logistic|||||||0.337
70991513|NCT02420223|141490971|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
70991514|NCT02420223|141490972|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
70991515|NCT02420223|141490973|SUPERIORITY|||||||0.06|||||||Likelihood ration Chi-Square test|||||||0.06
70991516|NCT05142332|141490981|SUPERIORITY||Adjusted absolute difference|11.9|||<|0.001|TWO_SIDED|95.0|4.5|19.3|||Regression, Logistic|||||19.3|4.5|<0.001
70991517|NCT05142332|141490982|SUPERIORITY||Adjusted absolute difference|7.9|||<|0.001|TWO_SIDED|95.0|1.7|14.1|||Regression, Logistic|||||14.1|1.7|<0.001
70991518|NCT01773135|141491022|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||U statistic|||||||<0.001
70991519|NCT00430625|141491065|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.429|STANDARD_ERROR_OF_MEAN|0.324|<|0.0001|TWO_SIDED|95.0|1.717|3.141|||paired t-test|||Primary endpoint was based solely on the 60 U/kg treatment arm||3.141|1.717|<0.0001
70991520|NCT00243230|141491072|SUPERIORITY||VCV 30 mg vs. Placebo|-0.98||||0.0017|TWO_SIDED|95.0|-1.58|-0.37|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||-0.37|-1.58|0.0017
70991521|NCT00243230|141491072|SUPERIORITY||VCV 20 mg vs. Placebo|-0.93||||0.0026||95.0|-1.54|-0.33|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||-0.33|-1.54|0.0026
70991522|NCT00243230|141491073|SUPERIORITY|||||||0.0052|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0052
70991523|NCT00243230|141491073|SUPERIORITY|||||||0.019|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0190
70991524|NCT00243230|141491074|SUPERIORITY|||||||0.0007|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0007
70991525|NCT00243230|141491074|SUPERIORITY|||||||0.0028|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0028
70991526|NCT00243230|141491076|SUPERIORITY||Vicriviroc 30mg - Placebo|-1.0||||0.0002|TWO_SIDED|95.0|-1.53|-0.48|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||-0.48|-1.53|0.0002
70991527|NCT00243230|141491076|SUPERIORITY||Vicriviroc 20 mg - Placebo|-0.84||||0.002|TWO_SIDED|95.0|-1.36|-0.31|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||-0.31|-1.36|0.0020
70991528|NCT00243230|141491077|SUPERIORITY||Vicriviroc 30 mg - Placebo|-1.1||||0.0003|TWO_SIDED|95.0|-1.69|-0.51|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA \<=100,000 copies/mL.||||-0.51|-1.69|0.0003
70991529|NCT00243230|141491077|SUPERIORITY||Vicriviroc 20 mg - Placebo|-1.07||||0.0004|TWO_SIDED|95.0|-1.66|-0.49|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA \<=100,000 copies/mL.||||-0.49|-1.66|0.0004
70991530|NCT00243230|141491078|SUPERIORITY||VCV 30 mg - Placebo|57.76||||0.0264|TWO_SIDED|95.0|6.9|108.61|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||108.61|6.90|0.0264
70991531|NCT00243230|141491078|SUPERIORITY||VCV 20 mg - Placebo|42.36||||0.102|TWO_SIDED|95.0|-8.55|93.28|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||93.28|-8.55|0.1020
70991532|NCT00243230|141491079|SUPERIORITY||VCV 30 mg - Placebo|38.12||||0.1525|TWO_SIDED|95.0|-14.32|90.56|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||90.56|-14.32|0.1525
70991533|NCT00243230|141491079|SUPERIORITY||VCV 20 mg - Placebo|44.12||||0.0987|TWO_SIDED|95.0|-8.38|96.61|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||96.61|-8.38|0.0987
70991534|NCT00243230|141491080|SUPERIORITY||VCV 30 mg - Placebo|37.32||||0.2603|TWO_SIDED|95.0|-28.05|102.68|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||102.68|-28.05|0.2603
70991535|NCT00243230|141491080|SUPERIORITY||VCV 20 mg - Placebo|69.08||||0.0387|TWO_SIDED|95.0|3.64|134.52|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||134.52|3.64|0.0387
70991536|NCT00243230|141491082|SUPERIORITY|||||||0.0031|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0031
70991537|NCT00243230|141491082|SUPERIORITY|||||||0.048|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0480
70991538|NCT00243230|141491083|SUPERIORITY|||||||0.0009|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0009
70991539|NCT00243230|141491083|SUPERIORITY|||||||0.0009|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0009
70991540|NCT00243230|141491085|SUPERIORITY|||||||0.0225|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0225
70991541|NCT00243230|141491085|SUPERIORITY|||||||0.0582|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0582
70991542|NCT00243230|141491086|SUPERIORITY|||||||0.0009|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0009
70991543|NCT00243230|141491086|SUPERIORITY|||||||0.0038|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0038
70991544|NCT00243230|141491087|SUPERIORITY|||||||0.0002|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0002
70991545|NCT00243230|141491087|SUPERIORITY|||||||0.0004|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0004
70991546|NCT03855137|141491141|SUPERIORITY||Least Squares Mean Difference|-2.41|STANDARD_ERROR_OF_MEAN|0.547||0.0001|TWO_SIDED|95.0|-3.48|-1.33||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|Mixed Model Repeated Measures (MMRM)||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.33|-3.48|0.0001
70991547|NCT03855137|141491141|SUPERIORITY||Least Squares Mean Difference|-1.82|STANDARD_ERROR_OF_MEAN|0.545||0.0009|TWO_SIDED|95.0|-2.89|-0.75||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-0.75|-2.89|0.0009
70991548|NCT03855137|141491142|SUPERIORITY||Least Squares Mean Difference|-2.24|STANDARD_ERROR_OF_MEAN|0.547||0.0001|TWO_SIDED|95.0|-3.31|-1.16||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.16|-3.31|0.0001
70991549|NCT03855137|141491142|SUPERIORITY||Least Squares Mean Difference|-1.66|STANDARD_ERROR_OF_MEAN|0.544||0.0024|TWO_SIDED|95.0|-2.72|-0.59|||MMRM|Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-0.59|-2.72|0.0024
70991550|NCT03855137|141491143|SUPERIORITY||Least Squares Mean Difference|-2.32|STANDARD_ERROR_OF_MEAN|0.541||0.0001|TWO_SIDED|95.0|-3.38|-1.26||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.26|-3.38|0.0001
70991551|NCT03855137|141491143|SUPERIORITY||Least Squares Mean Difference|-1.87|STANDARD_ERROR_OF_MEAN|0.538||0.0009|TWO_SIDED|95.0|-2.93|-0.81||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-0.81|-2.93|0.0009
70991552|NCT03855137|141491144|SUPERIORITY||Least Squares Mean Difference|-2.14|STANDARD_ERROR_OF_MEAN|0.539||0.0002|TWO_SIDED|95.0|-3.2|-1.09||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.09|-3.20|0.0002
70991553|NCT03855137|141491144|SUPERIORITY||Least Squares Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|0.536||0.0024|TWO_SIDED|95.0|-2.78|-0.67||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-0.67|-2.78|0.0024
70991554|NCT03855137|141491145|SUPERIORITY||Least Squares Mean Difference|-2.63|STANDARD_ERROR_OF_MEAN|0.51||0.0001|TWO_SIDED|95.0|-3.63|-1.63||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.63|-3.63|0.0001
70991555|NCT03855137|141491145|SUPERIORITY||Least Squares Mean Difference|-2.13|STANDARD_ERROR_OF_MEAN|0.508||0.0009|TWO_SIDED|95.0|-3.13|-1.13||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.13|-3.13|0.0009
70991556|NCT03855137|141491146|SUPERIORITY||Least Squares Mean Difference|-2.52|STANDARD_ERROR_OF_MEAN|0.507||0.0002|TWO_SIDED|95.0|-3.52|-1.53||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.53|-3.52|0.0002
70991557|NCT03855137|141491146|SUPERIORITY||Least Squares Mean Difference|-2.09|STANDARD_ERROR_OF_MEAN|0.505||0.0024|TWO_SIDED|95.0|-3.09|-1.1|||MMRM|||||-1.10|-3.09|0.0024
70991558|NCT03855137|141491147|SUPERIORITY||Odds Ratio (OR)|2.13||||0.0003|TWO_SIDED|95.0|1.45|3.14||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|Logistic regression||Logistic regression for each atogepant group versus placebo with baseline monthly migraine days as covariate,stratification of region,acute medication overuse,migraine prevention medication and number of failures,treatment group as fixed factors.|||3.14|1.45|0.0003
70991559|NCT03855137|141491147|SUPERIORITY||Odds Ratio (OR)|2.04||||0.0009|TWO_SIDED|95.0|1.38|3.0||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|Logistic regression||Logistic regression for each atogepant group versus placebo with baseline monthly migraine days as covariate,stratification of region,acute medication overuse,migraine prevention medication and number of failures,treatment group as fixed factors.|||3.00|1.38|0.0009
70991560|NCT03855137|141491148|SUPERIORITY||Odds Ratio (OR)|2.03||||0.0006|TWO_SIDED|95.0|1.38|2.98||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|Logistic regression||Logistic regression for each atogepant group versus placebo with baseline monthly migraine days as covariate,stratification of region,acute medication overuse,migraine prevention medication and number of failures,treatment group as fixed factors.|||2.98|1.38|0.0006
70991561|NCT03855137|141491148|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0009|TWO_SIDED|95.0|1.29|2.79||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|Logistic regression||Logistic regression for each atogepant group versus placebo with baseline monthly migraine days as covariate,stratification of region,acute medication overuse,migraine prevention medication and number of failures,treatment group as fixed factors.|||2.79|1.29|0.0009
70991562|NCT03855137|141491149|SUPERIORITY||Least Squares Mean Difference|7.43|STANDARD_ERROR_OF_MEAN|1.864||0.0006|TWO_SIDED|95.0|3.77|11.09||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||11.09|3.77|0.0006
70991563|NCT03855137|141491149|SUPERIORITY||Least Squares Mean Difference|5.78|STANDARD_ERROR_OF_MEAN|1.848||0.0024|TWO_SIDED|95.0|2.15|9.41||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||9.41|2.15|0.0024
70991564|NCT03855137|141491150|SUPERIORITY||Least Squares Mean Difference|-4.85|STANDARD_ERROR_OF_MEAN|0.968||0.0003|TWO_SIDED|95.0|-6.75|-2.95||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-2.95|-6.75|0.0003
70991565|NCT03855137|141491150|SUPERIORITY||Least Squares Mean Difference|-3.38|STANDARD_ERROR_OF_MEAN|0.963||0.0009|TWO_SIDED|95.0|-5.27|-1.49||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.49|-5.27|0.0009
71098806|NCT00098293|141706205|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.5874|TWO_SIDED|95.0|0.83|1.45|||Log Rank|||Week 48: P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio was calculated by fitting a Cox proportional hazards model including treatment group and the two randomization strata, HIV-1 RNA at screening and geographic region. Hazard ratio \< 1 would favor maraviroc.||1.45|0.83|0.5874
70991566|NCT03855137|141491151|SUPERIORITY||Least Squares Mean Difference|-4.19|STANDARD_ERROR_OF_MEAN|0.897||0.0003|TWO_SIDED|95.0|-5.95|-2.43||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-2.43|-5.95|0.0003
70991567|NCT03855137|141491151|SUPERIORITY||Least Squares Mean Difference|-2.71|STANDARD_ERROR_OF_MEAN|0.893||0.0025|TWO_SIDED|95.0|-4.47|-0.96||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-0.96|-4.47|0.0025
70991568|NCT03855137|141491152|SUPERIORITY||Least Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|0.697||0.0006|TWO_SIDED|95.0|-4.67|-1.93|||MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.93|-4.67|0.0006
70991569|NCT03855137|141491152|SUPERIORITY||Least Squares Mean Difference|-2.66|STANDARD_ERROR_OF_MEAN|0.69||0.0024|TWO_SIDED|95.0|-4.02|-1.3|||MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.30|-4.02|0.0024
71098807|NCT00098293|141706205|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.4811|TWO_SIDED|95.0|0.86|1.4|||Log Rank|||Week 96: P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio was calculated by fitting a Cox proportional hazards model including treatment group and the two randomization strata, HIV-1 RNA at screening and geographic region. Hazard ratio \< 1 would favor maraviroc.||1.40|0.86|0.4811
70991570|NCT02435277|141491158|OTHER|||||||0.0475||||||Total daily dose is twice the respective dose, Pairwise Comparison using Control as the Reference Group|ANCOVA|||Mixed Model Inferential Statistical Analysis of HbA1c change from day 1-day 84 Evaluable Population (n=43)||||0.0475
70991571|NCT02435277|141491158|OTHER|||||||0.0912|||||||ANCOVA|||||||0.0912
70991572|NCT02435277|141491158|OTHER|||||||0.0458|||||||ANCOVA|||||||0.0458
70991573|NCT02435277|141491159|OTHER|||||||0.26||||||Total daily dose is twice the respective dose Pairwise Comparison using Treatment D as the Reference Group|ANCOVA|||Mixed Model Inferential Statistical Analysis of Fssting Plasma Glucose change from day 1-day 84 in Evaluable Population (n=43)||||0.26
70991574|NCT02435277|141491159|OTHER|||||||0.0083|||||||ANCOVA|||||||0.0083
70991575|NCT02435277|141491159|OTHER|||||||0.0317|||||||ANCOVA|||||||0.0317
70991576|NCT00755846|141491164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.135||0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and body mass index (BMI), diabetes duration and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance has at least 98% power to detect a treatment difference (all active versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.001
70991577|NCT00755846|141491164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.171||0.004||95.0||||A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.004
70991578|NCT00755846|141491164|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.176||0.017||95.0||||A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.017
70991579|NCT00755846|141491164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.17||0.001||95.0||||A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.001
70991580|NCT00755846|141491164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.174||0.003||95.0||||A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.003
71039242|NCT01942135|141586345|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.6||||0.0845|TWO_SIDED|95.0|-0.5|7.6||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for future perspective||7.6|-0.5|0.0845
71039243|NCT01942135|141586346|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.7273|TWO_SIDED|95.0|-1.6|2.3||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for systemic therapy side effects||2.3|-1.6|0.7273
71039244|NCT01942135|141586346|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.2671|TWO_SIDED|95.0|-2.6|0.7||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for breast symptoms||0.7|-2.6|0.2671
71098808|NCT00098293|141706212|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was greater than (\>) -10%.|Difference in Percentage|-3.2|||||ONE_SIDED|97.5|-10.2|||||||Less than 400 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|||-10.2|
71098809|NCT00098293|141706212|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was \> -10%.|Difference in Percentage|-5.8|||||ONE_SIDED|97.5|-12.8|||||||Less than 50 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|||-12.8|
70991581|NCT00755846|141491164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.173||0.307||95.0||||A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.307
70991582|NCT00755846|141491165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.106||0.004||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has at least 98% power to detect a treatment difference (all active versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.004
70991583|NCT00755846|141491165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.134||0.017||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.017
70991584|NCT00755846|141491165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.138||0.016||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.016
70991585|NCT00755846|141491165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.134||0.005||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.005
71098810|NCT00098293|141706213|SUPERIORITY_OR_OTHER||Difference in Percentage|0.6|||||ONE_SIDED|97.5|-6.4|||||||Less than 400 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Due to its post-hoc nature, this analysis was considered descriptive only rather than inferential.|||-6.4|
71098811|NCT00098293|141706213|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.2|||||ONE_SIDED|97.5|-7.4|||||||Less than 50 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Due to its post-hoc nature, this analysis was considered descriptive only rather than inferential.|||-7.4|
71039245|NCT01942135|141586346|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.875|TWO_SIDED|95.0|-2.6|2.2||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for arm symptoms||2.2|-2.6|0.8750
70991586|NCT00755846|141491165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.137||0.008||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.008
70991587|NCT00755846|141491165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.136||0.321||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.321
70991588|NCT00755846|141491166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.2|STANDARD_ERROR_OF_MEAN|6.65|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and body mass index (BMI), diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting plasma glucose (FPG). The treatment effect was evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
70991589|NCT00755846|141491166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.5|STANDARD_ERROR_OF_MEAN|8.4|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
71039246|NCT01942135|141586346|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.9||||0.0255|TWO_SIDED|95.0|1.1|16.6||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for upset by hair loss||16.6|1.1|0.0255
71039247|NCT01942135|141586347|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.037||||0.0308|TWO_SIDED|95.0|0.0|0.07||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||0.07|0.00|0.0308
71039248|NCT01942135|141586348|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8||||0.5523|TWO_SIDED|95.0|-1.9|3.5||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||3.5|-1.9|0.5523
71039249|NCT01942135|141586349|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.642|||<|0.001|TWO_SIDED|95.0|0.487|0.846||The priori threshold for statistical significance is 1-sided alpha=0.025. The p-value was not adjusted for multiple comparisons.|Unstratified log-rank test (1-sided)|1-sided p-value from the unstratified log-rank test.|Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of the palbociclib plus fulvestrant arm.|Treatment with palbociclib plus fulvestrant significantly delayed TTD in pain symptom compared with placebo plus fulvestrant for unstratified analysis.||0.846|0.487|<0.001
71039250|NCT00950300|141586353|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the 90% confidence interval (CI) was greater than or equal to (≥) 0.8 for the geometric mean ratio.|Geometric mean ratio|1.33|||||TWO_SIDED|90.0|1.24|1.44|||||Ratio of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|PK sample size calculations based on percentage of coefficient of variation (CV%) for Ctrough of trastuzumab from previous metastatic breast cancer (MBC) and early breast cancer (EBC) studies. Because pre-surgery situation was comparable to MBC setting, interpatient CV% of 60 percent (%) was assumed and 130 participants per arm (260 participants total) were needed to demonstrate Ctrough comparability with 80% power if the true means of the two formulations did not differ by greater than (\>) 5%.||1.44|1.24|
71039251|NCT00950300|141586354|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the one-sided 97.5% CI was above -12.5% for the difference in response (pCR) rates.|Difference in response rates|4.7|||||ONE_SIDED|97.5|-4.0||||||The one-sided 97.5% CI for the difference in response (pCR) rates was calculated using the Anderson-Hauck continuity correction.|Assuming pCR rates of at least 40% in both arms, 552 participants were necessary to conclude non-inferiority in pCR rate with a power of 80% using a one-sided 97.5% CI for the difference of the response rates and a non-inferiority margin of 12.5%.|||-4.0|
71039252|NCT00950300|141586355|OTHER||Geometric mean ratio|1.51|||||TWO_SIDED|90.0|1.4|1.63|||||Ratio of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|Additional supportive analysis.||1.63|1.40|
70991590|NCT00755846|141491166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.8|STANDARD_ERROR_OF_MEAN|8.68||0.009||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.009
70991591|NCT00755846|141491166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.4|STANDARD_ERROR_OF_MEAN|8.38|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
70991592|NCT00755846|141491166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.4|STANDARD_ERROR_OF_MEAN|8.57||0.057||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.057
71098812|NCT00098293|141706214|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.4|||||ONE_SIDED|97.5|-7.9|||||||Less than 400 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Due to its post-hoc nature, this analysis was considered descriptive only rather than inferential.|||-7.9|
71098813|NCT00098293|141706214|SUPERIORITY_OR_OTHER||Difference in Percentage|-3.9|||||ONE_SIDED|97.5|-11.5|||||||Less than 50 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Due to its post-hoc nature, this analysis was considered descriptive only rather than inferential.|||-11.5|
71098814|NCT01370642|141706215|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|29.0|||<|0.001|TWO_SIDED|95.0|17.2|40.5|||Miettinen and Nurminen method|||To compare the percentage of participants achieving SVR24 between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by Interleukin 28B (IL28B) and age utilizing Cochran-Mantel-Haenszel weights.||40.5|17.2|<0.001
71098815|NCT01370642|141706215|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|28.6|||<|0.001|TWO_SIDED|95.0|17.4|40.0|||Miettinen and Nurminen method|||To compare the percentage of participants achieving SVR24 between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||40.0|17.4|<0.001
71098816|NCT01370642|141706216|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|30.0|||<|0.001|TWO_SIDED|95.0|18.1|41.5|||Miettinen and Nurminen method|||To compare the percentage of participants achieving SVR12 between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||41.5|18.1|<0.001
71098817|NCT01370642|141706216|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|29.6|||<|0.001|TWO_SIDED|95.0|18.3|41.0|||Miettinen and Nurminen method|||To compare the percentage of participants achieving SVR12 between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||41.0|18.3|<0.001
71098818|NCT01370642|141706217|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|78.1|||<|0.001|TWO_SIDED|95.0|68.2|85.3|||Miettinen and Nurminen method|||To compare the percentage of participants achieving RVR between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||85.3|68.2|<0.001
71098819|NCT01370642|141706217|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|76.7|||<|0.001|TWO_SIDED|95.0|66.7|84.1|||Miettinen and Nurminen method|||To compare the percentage of participants achieving RVR between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||84.1|66.7|<0.001
71098820|NCT01370642|141706218|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|48.4|||<|0.001|TWO_SIDED|95.0|37.2|58.9|||Miettinen and Nurminen method|||To compare the percentage of participants achieving cEVR between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||58.9|37.2|<0.001
71098821|NCT01370642|141706218|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|49.6|||<|0.001|TWO_SIDED|95.0|38.5|60.0|||Miettinen and Nurminen method|||To compare the percentage of participants achieving cEVR between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||60.0|38.5|<0.001
70991593|NCT00755846|141491166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|8.56||0.156||95.0||||No multiplicity adjustments|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.156
70991594|NCT00755846|141491167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.9|STANDARD_ERROR_OF_MEAN|7.05|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between all doses of alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
71039253|NCT00950300|141586356|OTHER||Geometric mean ratio|1.55|||||TWO_SIDED|90.0|1.46|1.64|||||Ratio of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|Additional supportive analysis.||1.64|1.46|
70991595|NCT00755846|141491167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.4|STANDARD_ERROR_OF_MEAN|8.91||0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.001
70991596|NCT00755846|141491167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.6|STANDARD_ERROR_OF_MEAN|9.2||0.008||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.008
71039254|NCT00950300|141586357|OTHER||Geometric mean ratio|1.55|||||TWO_SIDED|90.0|1.45|1.64|||||Ratio of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|Additional supportive analysis.||1.64|1.45|
71039255|NCT00950300|141586366|OTHER||Difference in response rates|5.01|||||TWO_SIDED|95.0|-3.5|13.5|||||The 95% CI for the difference in response (tpCR) rates was calculated using the Anderson-Hauck continuity correction.|||13.5|-3.5|
71039256|NCT00950300|141586367|OTHER||Difference in response rates|-1.64|||||TWO_SIDED|95.0|-7.4|4.2|||||The 95% CI for the difference in response (CR+PR) rates was calculated using the Anderson-Hauck continuity correction.|||4.2|-7.4|
71039257|NCT00950300|141586367|OTHER||Odds Ratio (OR)|0.86|||||TWO_SIDED|95.0|0.5|1.46|||||OR of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|||1.46|0.50|
71039258|NCT00950300|141586370|OTHER||Hazard Ratio (HR)|0.98||||0.8651|TWO_SIDED|95.0|0.74|1.29|||Log Rank||HR of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|||1.29|0.74|0.8651
71039259|NCT00950300|141586372|OTHER||Hazard Ratio (HR)|0.94||||0.7767|TWO_SIDED|95.0|0.61|1.45|||Log Rank||HR of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|||1.45|0.61|0.7767
71039260|NCT00494013|141586376|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority margin was 0.4%.|Mean Difference (Net)|-0.21||||0.026||95.0|-0.39|-0.03|||ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Determir).|Hypothesis: Basal analog insulin lispro protamine suspension, injected once or twice daily is noninferior to basal analog insulin determir, injected once or twice daily, with regard to glycemic control as measured by change in HbA1c from baseline to endpoint (last observation carried forward).||-0.03|-0.39|0.026
71039261|NCT00494013|141586377|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.213||95.0|-0.28|0.06||P-value for 12 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Detemir).|||0.06|-0.28|0.213
71039262|NCT00494013|141586377|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.213||95.0|-0.28|0.06||P-value for 12 Week HbA1c.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Detemir).|||0.06|-0.28|0.213
71039263|NCT00494013|141586377|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.038||95.0|-0.38|-0.01||P-value for 24 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Detemir).|||-0.01|-0.38|0.038
71039264|NCT00494013|141586377|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.038||95.0|-0.38|-0.01||P-value for Week 24 HbA1c.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Detemir).|||-0.01|-0.38|0.038
71039265|NCT00494013|141586378|SUPERIORITY_OR_OTHER|||||||0.463||95.0||||P-value for HbA1c \<7.0%.|Fisher Exact|||||||0.463
71039266|NCT00494013|141586378|SUPERIORITY_OR_OTHER|||||||0.135||95.0||||P-value for HbA1c ≤6.5%.|Fisher Exact|||||||0.135
71039267|NCT00494013|141586379|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin of 0.8 millimoles per Liter (mmol/L).|Mean Difference (Net)|0.1||||0.107||95.0|-0.02|0.23|||ANOVA|ANOVA model: Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Determir).|The first gatekeeping hypothesis was that Insulin Lispro Protamine Suspension was noninferior to determir.||0.23|-0.02|0.107
71039268|NCT00494013|141586380|SUPERIORITY_OR_OTHER|||||||0.952||95.0||||P-value for Average 7-Point SMBG.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.952
71039269|NCT00494013|141586380|SUPERIORITY_OR_OTHER|||||||0.856||95.0||||P-value for Average Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.856
71039270|NCT00494013|141586380|SUPERIORITY_OR_OTHER|||||||0.79||95.0||||P-value for Average Post-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.790
71039271|NCT00494013|141586380|SUPERIORITY_OR_OTHER|||||||0.632||95.0||||P-value for Average Morning+Evening Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.632
71039272|NCT00494013|141586381|SUPERIORITY_OR_OTHER|||||||0.472||95.0||||P-value for All Hypoglycemic Events.|Fisher Exact|||||||0.472
71039273|NCT00494013|141586381|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Nocturnal Hypoglycemic Events.|Fisher Exact|||||||0.005
71039274|NCT00494013|141586381|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||P-value for Severe Hypoglycemic Events.|Fisher Exact|||||||0.450
70991597|NCT00755846|141491167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.5|STANDARD_ERROR_OF_MEAN|8.88|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and body mass index, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
70991598|NCT00755846|141491167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.6|STANDARD_ERROR_OF_MEAN|9.09||0.136||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.136
70991599|NCT00755846|141491167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.3|STANDARD_ERROR_OF_MEAN|9.07||0.073||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.073
70991600|NCT00755846|141491168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5|STANDARD_ERROR_OF_MEAN|5.85|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
70991601|NCT00755846|141491168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.2|STANDARD_ERROR_OF_MEAN|7.37||0.01||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.010
70991602|NCT00755846|141491168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.8|STANDARD_ERROR_OF_MEAN|7.71||0.002||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.002
70991603|NCT00755846|141491168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.1|STANDARD_ERROR_OF_MEAN|7.33||0.003||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.003
71039275|NCT00494013|141586382|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.001
71039276|NCT00494013|141586382|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Nocturnal Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.001
71039277|NCT00494013|141586382|SUPERIORITY_OR_OTHER|||||||0.226||95.0||||P-value for Severe Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.226
71039278|NCT00494013|141586384|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin of 1.5 kilograms (kg).|Mean Difference (Net)|1.5|||<|0.001||95.0|0.93|2.06||P-value for Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Determir).|The second gatekeeping hypothesis was that Insulin Lispro Protamine Suspension was noninferior to detemir with regard to change in absolute body weight from baseline to endpoint (last observation carried forward).||2.06|0.93|<0.001
71039279|NCT00494013|141586385|SUPERIORITY_OR_OTHER|||||||0.074||95.0|||||ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group + Change in HbA1c from Baseline.||||||0.074
71039280|NCT00494013|141586386|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group + Change in HbA1c from Baseline.||||||0.039
71039281|NCT00494013|141586387|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Fisher Exact|||||||0.026
71039282|NCT00919711|141586391|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.6|||<|0.0001|TWO_SIDED|95.0|1.2|2.0|||ANCOVA||Denosumab - Risedronate|||2.0|1.2|<0.0001
70991604|NCT00755846|141491168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.7|STANDARD_ERROR_OF_MEAN|7.44||0.006||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.006
70991605|NCT00755846|141491168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.7|STANDARD_ERROR_OF_MEAN|7.45||0.117||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.117
71039283|NCT00919711|141586392|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71039284|NCT00919711|141586393|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.4|||<|0.0001|TWO_SIDED|95.0|0.9|1.8|||ANCOVA||Denosumab - Risedronate|||1.8|0.9|<0.0001
71039285|NCT00919711|141586394|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.3|||<|0.0001|TWO_SIDED|95.0|1.8|2.8|||ANCOVA||Denosumab - Risedronate|||2.8|1.8|<0.0001
71039286|NCT00087529|141586395|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.773||||0.1442|TWO_SIDED|95.0|0.546|1.093||Stratified using the following variables: Baseline EDSS (less than or equal to \[≤\] 4.0 versus \>4.0 points) and prior treatment with interferon-beta or glatiramer acetate.|Log Rank|||||1.093|0.546|0.1442
71039287|NCT00087529|141586397|SUPERIORITY_OR_OTHER||LS mean difference|-718.24||||0.0008|TWO_SIDED|95.0|-1504.48|68.0|||Friedman ranked ANOVA test|||Treatment difference in least-squares (LS) means and the associated 95% confidence intervals were estimated from the analysis of variance (ANOVA) model, which included the following factors: Baseline EDSS (≤ 4.0 versus \>4.0 points), prior treatment with interferon-beta or glatiramer acetate, and treatment group.||68.00|-1504.48|0.0008
71039288|NCT00087529|141586398|SUPERIORITY_OR_OTHER||LS mean difference|-1.08||||0.6237|TWO_SIDED|95.0|-9.49|7.34|||Friedman ranked ANOVA test|||Treatment difference in LS means and the associated 95% confidence intervals were estimated from the ANOVA model, which included the following factors: Baseline EDSS (≤ 4.0 versus \>4.0 points), prior treatment with interferon-beta or glatiramer acetate, and treatment group.||7.34|-9.49|0.6237
71039289|NCT02488109|141586438|OTHER|||||||0.42||||||Changes in rates of clinical remission by group over time in the mITT model.|Regression, Linear|Clinical remission was modeled as a nominal multinomial outcome (yes, no, or missing)||The study was powered to detect a difference in 12-months clinical remission rates between groups. N = 60 per arm with 85% retention would provide 80% power on a 2-sided 0.05-level test to detect a 20% difference between groups in 12-months clinical remission rates. A generalized linear mixed-effects regression model was used to compare study arms with respect to achievement and maintenance of clinical remission.||||0.42
70991606|NCT00755846|141491169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.3|STANDARD_ERROR_OF_MEAN|6.6||0.014||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.014
71039290|NCT02488109|141586439|SUPERIORITY||Hazard Ratio (HR)|1.67||||0.01|TWO_SIDED|95.0|1.1|2.53||Survival analysis of time to medical stability by log-rank test, which does not assume proportional hazards. Those who did not reach medical stability before hospital discharge were censored; analyses accounted for the site effect by stratification.|Survival analysis with log rank test|Compared time to achieve medical stability by arm; participants who did not meet stability criteria by hospital discharge were right-censored||This trial was powered at 0.80 to detect a 12% to 20% difference in restored medical stability at 0.05 type I error and correlation between time points from 0.1 to 1.||2.53|1.10|0.01
71039291|NCT02488109|141586440|SUPERIORITY||Median Difference (Net)|19.0||||0.002|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Cost outcomes of group differences and 95% confidence intervals were estimated.||28,819|9,293|0.002
71098822|NCT01370642|141706219|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|17.0|||<|0.001|TWO_SIDED|95.0|8.1|27.3|||Miettinen and Nurminen method|||To compare the percentage of participants achieving undetectable HCV RNA at EOT between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||27.3|8.1|<0.001
71098823|NCT01370642|141706219|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|17.8|||<|0.001|TWO_SIDED|95.0|9.3|27.8|||Miettinen and Nurminen method|||To compare the percentage of participants achieving undetectable HCV RNA at EOT between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||27.8|9.3|<0.001
71039292|NCT03969641|141586441|NON_INFERIORITY|This objective will be assessed using a one-sided noninferiority test with the alpha level set at 0.025 (1-sided) and a noninferiority margin of 10%.|Difference in Proportions (RIV4 - IIV4)|-0.0214|||<|0.0001|ONE_SIDED|97.5||0.0406|||Cochran-Mantel-Haenszel|The upper bound of a Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used, stratified by site.|The directional comparison was the upper bound of the confidence interval using a 10% noninferiority margin.|The null hypothesis assumes that RIV4 is inferior (i.e., RIV4 will have a higher proportion) to IIV4 in regards to the proportion of pregnant women with adverse birth outcomes.||0.0406||<0.0001
70991607|NCT00755846|141491169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.5|STANDARD_ERROR_OF_MEAN|8.35||0.136||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.136
70991608|NCT00755846|141491169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.1|STANDARD_ERROR_OF_MEAN|8.73||0.022||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.022
71098824|NCT01370642|141706220|SUPERIORITY_OR_OTHER||Difference in percentages|4.1||||0.385|TWO_SIDED|95.0|-5.4|13.7|||Miettinen and Nurminen method|||Difference in percentage of participants with ≥1 Tier 1 AEs between vaniprevir and control.||13.7|-5.4|0.385
70991609|NCT00755846|141491169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.1|STANDARD_ERROR_OF_MEAN|8.26||0.004||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.004
70991610|NCT00755846|141491169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.5|STANDARD_ERROR_OF_MEAN|8.48||0.04||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.040
70991611|NCT00755846|141491169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5|STANDARD_ERROR_OF_MEAN|8.47||0.378||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.378
70991612|NCT00755846|141491170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|5.37||0.718||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.718
71039293|NCT03969641|141586442|SUPERIORITY|This proportion was compared between the RIV4 group and the IIV4 group using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level. The site adjusted odds ratio and corresponding 95% confidence interval for the proportion of preterm birth was also calculated.|Odds Ratio (OR)|0.72||||0.4645|TWO_SIDED|95.0|0.35|1.48|||Mantel Haenszel|||Preterm birth||1.48|0.35|0.4645
71039294|NCT03969641|141586443|SUPERIORITY|These proportions were compared between the RIV4 group and the IIV4 group using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level. The site adjusted odds ratio and corresponding 95% confidence interval for the proportions of combined fetal death and neonatal death was also calculated.|Odds Ratio (OR)|0.00000031||||0.2447|TWO_SIDED|95.0|0.0||The upper limit of this CI is infinity, thus no numeric value can be provided.||Mantel Haenszel|||Fetal or neonatal death|||0.00|0.2447
71039295|NCT03969641|141586444|SUPERIORITY|This proportion was compared between the RIV4 group and the IIV4 group using an exact Mantel-Haenszel statistic in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level. The site adjusted odds ratio and corresponding 95% confidence interval for the proportion of spontaneous abortion after vaccination was also calculated. This was a subgroup analysis of only those participants vaccinated at less than 20 weeks gestational age.|Odds Ratio (OR)|0.5||||0.6235|TWO_SIDED|95.0|0.04|5.47|||Mantel Haenszel|||Spontaneous abortion||5.47|0.04|0.6235
71039296|NCT03969641|141586445|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|1.17||||0.7029|TWO_SIDED|95.0|0.55|2.5|||Mantel Haenszel|||Injection Site Pain||2.50|0.55|0.7029
71098825|NCT01370642|141706220|SUPERIORITY_OR_OTHER||Difference in percentages|-2.2||||0.67|TWO_SIDED|95.0|-12.6|8.1|||Miettinen and Nurminen method|||Difference in percentage of participants with ≥1 Tier 1 AEs between vaniprevir and control.||8.1|-12.6|0.670
70991613|NCT00755846|141491170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4|STANDARD_ERROR_OF_MEAN|6.8||0.346||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.346
70991614|NCT00755846|141491170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|7.13||0.901||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.901
70991615|NCT00755846|141491170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|6.79||0.851||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.851
70991616|NCT00755846|141491170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|6.86||0.825||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.825
70991617|NCT00755846|141491170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|6.94||0.843||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.843
70991618|NCT00755846|141491171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|STANDARD_ERROR_OF_MEAN|4.88||0.069||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.069
70991619|NCT00755846|141491171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.6|STANDARD_ERROR_OF_MEAN|6.14||0.018||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.018
71098826|NCT01370642|141706220|SUPERIORITY_OR_OTHER||Difference in percentages|-4.1||||0.557|TWO_SIDED|95.0|-17.5|9.5|||Miettinen and Nurminen method|||Difference in percentage of participants with anemia Tier 1 AEs between vaniprevir and control.||9.5|-17.5|0.557
70991620|NCT00755846|141491171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.3|STANDARD_ERROR_OF_MEAN|6.47||0.258||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.258
71098827|NCT01370642|141706220|SUPERIORITY_OR_OTHER||Difference in percentages|-12.7||||0.072|TWO_SIDED|95.0|-26.2|1.2|||Miettinen and Nurminen method|||Difference in percentage of participants with anemia Tier 1 AEs between vaniprevir and control.||1.2|-26.2|0.072
70991621|NCT00755846|141491171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4|STANDARD_ERROR_OF_MEAN|6.13||0.299||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.299
70991622|NCT00755846|141491171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.3|STANDARD_ERROR_OF_MEAN|6.27||0.103||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.103
70991623|NCT00755846|141491171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0|STANDARD_ERROR_OF_MEAN|6.32||0.34||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.340
70991624|NCT00755846|141491172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.83||0.689||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.689
70991625|NCT00755846|141491172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|1.05||0.742||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.742
70991626|NCT00755846|141491172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.11||0.22||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.220
70991627|NCT00755846|141491172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|1.05||0.348||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.348
71098828|NCT01370642|141706220|SUPERIORITY_OR_OTHER||Difference in percentages|0.0|||>|0.999|TWO_SIDED|95.0|-7.9|7.9|||Miettinen and Nurminen method|||Difference in percentage of participants with bilirubin increased Tier 1 AEs between vaniprevir and control.||7.9|-7.9|>0.999
71098829|NCT01370642|141706220|SUPERIORITY_OR_OTHER||Difference in percentages|5.2||||0.22|TWO_SIDED|95.0|-3.3|14.2|||Miettinen and Nurminen method|||Difference in percentage of participants with bilirubin increased Tier 1 AEs between vaniprevir and control.||14.2|-3.3|0.220
71098830|NCT01370642|141706220|SUPERIORITY_OR_OTHER||Difference in percentages|15.3||||0.032|TWO_SIDED|95.0|1.3|28.7|||Miettinen and Nurminen method|||Difference in percentage of participants with GI Tier 1 AEs between vaniprevir and control.||28.7|1.3|0.032
70991628|NCT00755846|141491172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|1.06||0.627||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.627
70991629|NCT00755846|141491172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|1.06||0.418||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.418
71098831|NCT01370642|141706220|SUPERIORITY_OR_OTHER||Difference in percentages|5.6||||0.432|TWO_SIDED|95.0|-8.4|19.4|||Miettinen and Nurminen method|||Difference in percentage of participants with GI Tier 1 AEs between vaniprevir and control.||19.4|-8.4|0.432
71098832|NCT01370642|141706220|SUPERIORITY_OR_OTHER||Difference in percentages|8.2||||0.252|TWO_SIDED|95.0|-5.8|21.8|||Miettinen and Nurminen method|||Difference in percentage of participants with neutropenia Tier 1 AEs between vaniprevir and control.||21.8|-5.8|0.252
71098833|NCT01370642|141706220|SUPERIORITY_OR_OTHER||Difference in percentages|0.5||||0.942|TWO_SIDED|95.0|-13.4|14.4|||Miettinen and Nurminen method|||Difference in percentage of participants with neutropenia Tier 1 AEs between vaniprevir and control.||14.4|-13.4|0.942
71098834|NCT01370642|141706221|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 2|-3.2|||||TWO_SIDED|95.0|-3.5|-3.0|||Constrained LDA Model|||Change from BL in HCV RNA at Week 2 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-3.0|-3.5|
71098835|NCT01370642|141706221|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 2|-3.5|||||TWO_SIDED|95.0|-3.7|-3.2|||Constrained LDA Model|||Change from BL in HCV RNA at Week 2 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-3.2|-3.7|
71098836|NCT01370642|141706221|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 4|-3.0|||||TWO_SIDED|95.0|-3.3|-2.7|||Constrained LDA Model|||Change from BL in HCV RNA at Week 4 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-2.7|-3.3|
71098837|NCT01370642|141706221|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 4|-3.1|||||TWO_SIDED|95.0|-3.4|-2.8|||Constrained LDA Model|||Change from BL in HCV RNA at Week 4 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-2.8|-3.4|
71098838|NCT01370642|141706221|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 8|-1.9|||||TWO_SIDED|95.0|-2.2|-1.6|||Constrained LDA Model|||Change from BL in HCV RNA at Week 8 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-1.6|-2.2|
71098839|NCT01370642|141706221|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 8|-2.0|||||TWO_SIDED|95.0|-2.3|-1.7|||Constrained LDA Model|||Change from BL in HCV RNA at Week 8 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-1.7|-2.3|
70991630|NCT00755846|141491173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.95||0.617||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.617
70991631|NCT00755846|141491173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|1.2||0.052||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.052
70991632|NCT00755846|141491173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|1.28||0.906||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.906
70991633|NCT00755846|141491173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.19||0.628||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.628
70991634|NCT00755846|141491173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.22||0.749||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.749
70991635|NCT00755846|141491173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.22||0.34||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.340
70991636|NCT00755846|141491174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|4.31||0.269||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.269
71039297|NCT03969641|141586445|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|2.03||||0.6217|TWO_SIDED|95.0|0.18|22.52|||Mantel Haenszel|||Injection Site Redness||22.52|0.18|0.6217
70991637|NCT00755846|141491174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7|STANDARD_ERROR_OF_MEAN|5.46||0.076||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.076
70991638|NCT00755846|141491174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|5.66||0.867||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.867
70991639|NCT00755846|141491174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.4|STANDARD_ERROR_OF_MEAN|5.4||0.169||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.169
70991640|NCT00755846|141491174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|STANDARD_ERROR_OF_MEAN|5.45||0.645||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.645
70991641|NCT00755846|141491174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|5.51||0.351||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.351
70991642|NCT00755846|141491175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.3|STANDARD_ERROR_OF_MEAN|4.03||0.003||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.003
71098840|NCT01370642|141706221|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 12|-1.4|||||TWO_SIDED|95.0|-1.7|-1.1|||Constrained LDA Model|||Change from BL in HCV RNA at Week 12 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-1.1|-1.7|
70991643|NCT00755846|141491175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.6|STANDARD_ERROR_OF_MEAN|5.06|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
70991644|NCT00755846|141491175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|5.26||0.103||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.103
70991645|NCT00755846|141491175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.0|STANDARD_ERROR_OF_MEAN|4.98||0.009||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.009
70923113|NCT04840199|141337472|SUPERIORITY||Mean Difference (Net)|0.0023||||0.17|TWO_SIDED|95.0|-0.001|0.0055||No adjustment for multiple comparisons|GEE model for repeated outcomes|P-value is from the time and treatment group interaction in the post treatment phase.|Treatment effect was estimated as the difference in weekly rate of change (slope) in log10 sTNFRII with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between arms).|Post treatment phase comparison||0.0055|-0.0010|0.17
70923114|NCT02201108|141337478|SUPERIORITY||Hazard Ratio (HR)|0.657||||0.2949|TWO_SIDED|95.0|0.388|1.113||Threshold for significance was \< 0.05.|Stratified Log-Rank test|P-value derived from log-rank test with stratification of region and pubertal status.|Hazard ratio was estimated using a Cox proportional-hazards model with factors for treatment group, region, pubertal status, age, and number of relapses in the year prior to randomization as covariates and with robust variance estimation.|||1.113|0.388|0.2949
70923115|NCT02201108|141337480|OTHER||Relative risk ratio|0.511|||||TWO_SIDED|95.0|0.343|0.762||||||||0.762|0.343|
70923116|NCT02201108|141337481|OTHER||Relative risk ratio|0.57|||||TWO_SIDED|95.0|0.331|0.983||||||||0.983|0.331|
70923117|NCT02201108|141337484|OTHER||Relative risk ratio|0.498|||||TWO_SIDED|95.0|0.296|0.836||||||||0.836|0.296|
70923118|NCT02201108|141337498|OTHER||Hazard Ratio (HR)|0.693|||||TWO_SIDED|95.0|0.37|1.296|||||Hazard ratio estimated using a Cox proportional-hazards model using treatment group, region, pubertal status, age, and number of relapses in the year prior to randomisation as covariates and with robust variance estimation.|||1.296|0.37|
70991646|NCT00755846|141491175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|5.14||0.034||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.034
70991647|NCT00755846|141491175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.1|STANDARD_ERROR_OF_MEAN|5.16||0.033||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.033
70991648|NCT00755846|141491176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|17.17||0.897||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.897
71098841|NCT01370642|141706221|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 12|-1.4|||||TWO_SIDED|95.0|-1.7|-1.1|||Constrained LDA Model|||Change from BL in HCV RNA at Week 12 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-1.1|-1.7|
71098842|NCT01370642|141706221|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 24|-0.8|||||TWO_SIDED|95.0|-1.1|-0.5|||Constrained LDA Model|||Change from BL in HCV RNA at Week 24 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-0.5|-1.1|
70991649|NCT00755846|141491176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.8|STANDARD_ERROR_OF_MEAN|21.85||0.557||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.557
70991650|NCT00755846|141491176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.5|STANDARD_ERROR_OF_MEAN|22.85||0.616||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.616
70991651|NCT00755846|141491176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|STANDARD_ERROR_OF_MEAN|21.73||0.679||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.679
70991652|NCT00755846|141491176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.5|STANDARD_ERROR_OF_MEAN|21.94||0.697||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.697
70991653|NCT00755846|141491176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.4|STANDARD_ERROR_OF_MEAN|22.03||0.672||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.672
70991654|NCT00755846|141491177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|16.37||0.809||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.809
70991655|NCT00755846|141491177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0|STANDARD_ERROR_OF_MEAN|20.74||0.597||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.597
70991656|NCT00755846|141491177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|21.77||0.982||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.982
70991657|NCT00755846|141491177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.0|STANDARD_ERROR_OF_MEAN|20.62||0.358||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.358
70991658|NCT00755846|141491177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.1|STANDARD_ERROR_OF_MEAN|21.06||0.274||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.274
71098843|NCT01370642|141706221|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 24|-0.9|||||TWO_SIDED|95.0|-1.2|-0.6|||Constrained LDA Model|||Change from BL in HCV RNA at Week 24 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-0.6|-1.2|
70923129|NCT05215847|141337523|OTHER|Adverse event subject incidence and event frequency.|||||||||||||||||Adverse event subject incidence and event frequency.|||
71098844|NCT01927861|141706235|OTHER||Treatment difference|0.63|||<|0.0001|TWO_SIDED|95.0|0.38|0.88|||ANCOVA|||The change from baseline (week 0) in the height SDS after 104 weeks of treatment was analysed using an ANCOVA model with treatment as a fixed effect and baseline height SDS as a covariate.||0.88|0.38|< 0.0001
70923130|NCT05145257|141337568|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
70923131|NCT05145257|141337569|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
70923132|NCT05145257|141337570|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
70923133|NCT05145257|141337571|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
70923134|NCT05145257|141337572|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
70923135|NCT05145257|141337573|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
70923136|NCT05145257|141337574|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
70991659|NCT00755846|141491177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.5|STANDARD_ERROR_OF_MEAN|21.06||0.554||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.554
70991660|NCT02669862|141491189|OTHER|||||||0.555|||||||ANCOVA|Baseline values were the covariate||"In this table Study Day 01 / Visit 2 has been considered as Baseline visit for calculating mean and mean change.~PVal\*- ANCOVA used for calculating P-value by comparing Vehicle against each Active treatment group using baseline values as the covariate."||||0.555
70991661|NCT02669862|141491189|OTHER|||||||0.009||||||PVal\*- ANCOVA used for calculating P-value by comparing Vehicle against each Active treatment group using baseline values as the covariate. No adjustments for multiple comparisons.|ANCOVA|||"In this table Study Day 01 / Visit 2 has been considered as Baseline visit for calculating mean and mean change.~PVal\*- ANCOVA used for calculating P-value by comparing Vehicle against each Active treatment group using baseline values as the covariate."||||0.009
70991662|NCT02669862|141491191|OTHER|||||||0.9313||||||Not adjusted for multiple comparisons|Chi-squared|||PVal\*- Chi-Square test used for calculating P-value by comparing Vehicle against each Active treatment group||||0.9313
70991663|NCT02669862|141491191|OTHER|||||||0.0236||||||Not adjusted for multiple comparisons|Chi-squared|||||||0.0236
70991664|NCT02429258|141491192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.0|STANDARD_ERROR_OF_MEAN|6.08|<|0.001||95.0|-36.1|-12.0|||Mixed Models Analysis|||||-12.0|-36.1|<0.001
70991665|NCT02429258|141491193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3|STANDARD_ERROR_OF_MEAN|5.8||0.01||95.0|-26.8|-3.8|||ANCOVA|||||-3.8|-26.8|0.010
70923137|NCT05145257|141337575|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
70923138|NCT05145257|141337576|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
70923139|NCT05145257|141337577|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
70923140|NCT05145257|141337578|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
70923141|NCT05145257|141337579|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
70923142|NCT05145257|141337580|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
70923143|NCT05145257|141337581|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
70923144|NCT05145257|141337582|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
70923145|NCT05145257|141337583|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
70991666|NCT02429258|141491194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.42||0.023||95.0|0.1|1.8|||ANCOVA|||||1.8|0.1|0.023
70923146|NCT06023082|141337584|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
70923147|NCT06023082|141337585|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
70923148|NCT06023082|141337586|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
70991667|NCT02429258|141491195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.0|STANDARD_ERROR_OF_MEAN|3.65|<|0.001||95.0|7.7|22.2|||ANCOVA|||||22.2|7.7|<0.001
70991668|NCT02429258|141491196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.1|STANDARD_ERROR_OF_MEAN|3.72|<|0.001||95.0|-23.5|-8.7|||ANCOVA|||||-8.7|-23.5|<0.001
70991669|NCT02429258|141491197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.7|STANDARD_ERROR_OF_MEAN|8.47|<|0.001||95.0|-46.6|-12.9|||ANCOVA|||||-12.9|-46.6|<0.001
70991670|NCT02429258|141491198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.8|STANDARD_ERROR_OF_MEAN|9.14|<|0.001||95.0|-59.0|-22.7|||ANCOVA|||||-22.7|-59.0|<0.001
70991671|NCT02429258|141491199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.1||0.024||95.0|-0.43|-0.03|||ANCOVA|||||-0.03|-0.43|0.024
70991672|NCT02429258|141491200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|STANDARD_ERROR_OF_MEAN|4.55||0.019||95.0|-19.9|-1.8|||ANCOVA|||||-1.8|-19.9|0.019
70991673|NCT02429258|141491201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.3|STANDARD_ERROR_OF_MEAN|9.25|<|0.001||95.0|-54.7|-17.9|||ANCOVA|||||-17.9|-54.7|<0.001
70991674|NCT02429258|141491202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|STANDARD_ERROR_OF_MEAN|2.86||0.017||95.0|1.3|12.7|||ANCOVA|||||12.7|1.3|0.017
70991675|NCT02397694|141491203|NON_INFERIORITY|Noninferiority of treatment with BIC + F/TAF relative to treatment with DTG + F/TAF. Noninferiority assessed using a conventional 95% confidence interval (CI) approach, with a noninferiority margin of 12%|Difference in percentages|2.9||||0.5|TWO_SIDED|95.0|-8.5|14.2|||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline HIV-1 RNA stratum (≤ 100,000 copies/mL vs \> 100,000 copies/mL).||||14.2|-8.5|0.5
70991676|NCT02320695|141491263|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.12||0.187|TWO_SIDED|95.0|-0.33|0.05|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||0.05|-0.33|0.187
70991677|NCT02320695|141491263|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.101|TWO_SIDED|95.0|-0.42|0.04|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||0.04|-0.42|0.101
70991678|NCT02320695|141491263|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|0.12||0.002|TWO_SIDED|95.0|-0.49|-0.1|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||-0.10|-0.49|0.002
70991679|NCT02320695|141491263|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.53|-0.12|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||-0.12|-0.53|<0.001
70991680|NCT02320695|141491264|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.12||0.023|TWO_SIDED|95.0|-0.54|-0.05|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||-0.05|-0.54|0.023
70991681|NCT02320695|141491264|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.12||0.522|TWO_SIDED|95.0|-0.32|0.2|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||0.20|-0.32|0.522
70991682|NCT02320695|141491264|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.37|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.67|-0.16|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||-0.16|-0.67|<0.001
70991683|NCT02320695|141491264|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|0.12||0.013|TWO_SIDED|95.0|-0.63|-0.07|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||-0.07|-0.63|0.013
70991684|NCT02207478|141491269|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.019
70991685|NCT02207478|141491270|SUPERIORITY_OR_OTHER|||||||0.843|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Total procedure time||||0.843
70991686|NCT02207478|141491270|SUPERIORITY_OR_OTHER|||||||0.233|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Total X-ray time||||0.233
70991687|NCT02207478|141491270|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Duration time for finding lesions||||<0.001
70991688|NCT02207478|141491270|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||X-ray time for finding lesions||||<0.001
70991689|NCT01640925|141491278|NON_INFERIORITY_OR_EQUIVALENCE|The number of patients needed to achieve 80% power was estimated at 171 using Cox proportional hazards regression (hazard ratio reduction of 0.66; 0.15 probability of infection with control) using a two-sided 5% significance.|Cox Proportional Hazard|0.555||||0.049|TWO_SIDED|95.0|0.309|0.998|||Regression, Cox||Hypothesis: Compared to soap and water daily bathing, 2% chlorhexidine gluconate bathing on ICU admission and every 48 hours during surgical ICU care will decrease the risk of acquiring four hospital-acquired infections in surgical ICU patients.|||0.998|0.309|0.049
70991690|NCT00442013|141491287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.086||0.12|TWO_SIDED|95.0|0.0|0.3|||Regression, Linear|Linear mixed effects model is robust to data that are missing at random that has characteristics similar to multiple imputation techniques.||All participants included in the analysis. The model includes the data (ACQ scores) from all time points including baseline. The treatment effect (delta-delta) comparing the difference from baseline at 6 months is estimated from the model. Longitudinal models estimated the change from baseline to 6 months in a measurement using generalized estimating equations with an unstructured or exchangeable covariance matrix to adjust for repeated measures.||0.3|0.0|0.12
70991691|NCT00442013|141491288|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.2593||0.65|TWO_SIDED|95.0|-0.3|0.2|||Regression, Linear|||||0.2|-0.3|0.65
70991692|NCT00442013|141491289|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.0906||0.99|TWO_SIDED|95.0|-0.1|0.1|||Regression, Linear|||||0.1|-0.1|0.99
70991693|NCT00442013|141491290|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.3|TWO_SIDED|95.0|0.9|1.7|||negative binomial|||||1.7|0.9|0.30
70991694|NCT00442013|141491291|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.02||0.14|TWO_SIDED|95.0|-0.07|0.01|||Regression, Linear|Model includes the data from all time points. Treatment effect (delta-delta) comparing the difference from baseline at 24 weeks is from the model.||||0.01|-0.07|0.14
71039298|NCT03969641|141586445|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.7||||0.3848|TWO_SIDED|95.0|0.35|1.39|||Mantel Haenszel|||Injection Site Tenderness||1.39|0.35|0.3848
71039299|NCT03969641|141586445|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.53||||0.2504|TWO_SIDED|95.0|0.21|1.35|||Mantel Haenszel|||Nausea||1.35|0.21|0.2504
71039300|NCT03969641|141586445|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.62||||0.5751|TWO_SIDED|95.0|0.2|1.93|||Mantel Haenszel|||Vomiting||1.93|0.20|0.5751
71039301|NCT03969641|141586445|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|1.01||||1|TWO_SIDED|95.0|0.32|3.19|||Mantel Haenszel|||Diarrhea||3.19|0.32|1.0000
71098845|NCT00987935|141706303|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.357|||||TWO_SIDED|95.0|0.802|2.296|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||2.296|0.802|
70991695|NCT00442013|141491292|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.2|TWO_SIDED|95.0|-2.1|0.4|||Regression, Linear|||||0.4|-2.1|0.20
70991696|NCT04131517|141491293|OTHER|A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL + OC and OC Alone of the least squares (LS) means for the log-transformed Cmax was within the bioequivalence acceptance range of 80% to 125%.|Geometric LS Mean ratio|1.0404|||||TWO_SIDED|90.0|0.94156|1.1497||||||The analysis of variance model (ANOVA) included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect.||1.1497|0.94156|
70991697|NCT04131517|141491294|OTHER|A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL + OC and OC Alone of the LS means for the log-transformed Cmax was within the bioequivalence acceptance range of 80% to 125%.|Geometric LS Mean ratio|0.89272|||||TWO_SIDED|90.0|0.76892|1.0364||||||The ANOVA model included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect.||1.0364|0.76892|
70991698|NCT04131517|141491297|OTHER|A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL + OC and OC Alone of the LS means for the log-transformed AUC0-inf was within the bioequivalence acceptance range of 80% to 125%.|Geometric LS Mean ratio|1.0276|||||TWO_SIDED|90.0|0.95544|1.1052||||||The ANOVA model included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect.||1.1052|0.95544|
70991699|NCT04131517|141491298|OTHER|A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL+ OC and OC Alone of the LS means for the log-transformed AUC0-inf was within the bioequivalence acceptance range of 80% to 125%.|Geometric LS Mean ratio|0.88808|||||TWO_SIDED|90.0|0.52185|1.5113||||||The ANOVA model included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect.||1.5113|0.52185|
71039302|NCT03969641|141586445|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.8||||1|TWO_SIDED|95.0|0.21|3.04|||Mantel Haenszel|||Abdominal Pain||3.04|0.21|1.0000
71039303|NCT03969641|141586445|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.53||||0.1326|TWO_SIDED|95.0|0.25|1.13|||Mantel Haenszel|||Headache||1.13|0.25|0.1326
70991700|NCT04131517|141491305|OTHER|A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL + OC and OC Alone of the LS means for the log-transformed Cmax was within the bioequivalence acceptance range of 80% to 125%.|Geometric LS Mean ratio|0.96378|||||TWO_SIDED|90.0|0.85043|1.0922||||||The ANOVA model included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect.||1.0922|0.85043|
70991701|NCT04131517|141491307|OTHER|A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL + OC and OC Alone of the LS means for the log-transformed AUC was within the bioequivalence acceptance range of 80% to 125%.|Geometric LS Mean ratio|0.96842|||||TWO_SIDED|90.0|0.91888|1.0206||||||The ANOVA model included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect.||1.0206|0.91888|
70991702|NCT04149899|141491309|OTHER|The null hypothesis is that the mean change from Baseline, Hour 2 = 0 at Day 14, Hour 2.|Mean Difference (Net)|-4.9|STANDARD_DEVIATION|1.85|<|0.001|TWO_SIDED|95.0|-5.73|-4.14||The p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||A within-group comparison was performed between Baseline, Hour 2 and Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5%.||-4.14|-5.73|<0.001
70991703|NCT04149899|141491309|OTHER|The null hypothesis is that the mean change from Baseline, Hour 2 = 0 at Day 14, Hour 2.|Mean Difference (Net)|-5.1|STANDARD_DEVIATION|2.51|<|0.001|TWO_SIDED|95.0|-6.14|-4.02||The p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||A within-group comparison was performed between Baseline, Hour 2 and Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5%.||-4.02|-6.14|<0.001
70991704|NCT04149899|141491309|OTHER|The null hypothesis is that the mean change from Baseline, Hour 2 = 0 at Day 14, Hour 2.|Mean Difference (Net)|-6.0|STANDARD_DEVIATION|3.05|<|0.001|TWO_SIDED|95.0|-7.93|-4.07||The p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||A within-group comparison was performed between Baseline, Hour 2 and Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5%.||-4.07|-7.93|<0.001
70991705|NCT04149899|141491309|NON_INFERIORITY|A pairwise treatment group comparison was performed versus timolol ophthalmic solution 0.5%. A 2-sided 95% confidence interval (CI) for the treatment difference (WB007 minus Timolol) was constructed based on an ANCOVA model. If WB007 was determined to be non-inferior to Timolol, an attempt to show superiority of WB007 over Timolol was made.|Mean Difference (Net)|0.14||||0.828|TWO_SIDED|95.0|-1.16|1.43||The p-value (2-sided) for superiority was not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model used the Baseline IOP values at Hour 2 as the covariate.|The estimated treatment difference is based on the least-square means from the ANCOVA model.|The mean IOP change from Baseline, Hour 2 to Day 14, Hour 2 (the timepoint for the peak effect of Timolol 0.5%) was compared between WB007 0.15% and Timolol 0.5%.||1.43|-1.16|0.828
70991706|NCT04149899|141491309|NON_INFERIORITY|A pairwise treatment group comparison was performed versus timolol ophthalmic solution 0.5%. A 2-sided 95% confidence interval (CI) for the treatment difference (WB007 minus Timolol) was constructed based on an ANCOVA model. If WB007 was determined to be non-inferior to Timolol, an attempt to show superiority of WB007 over Timolol was made.|Mean Difference (Net)|-0.42||||0.52|TWO_SIDED|95.0|-1.73|0.89||The p-value (2-sided) for superiority was not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model used the Baseline IOP values at Hour 2 as the covariate.|The estimated treatment difference is based on the least-square means from the ANCOVA model.|The mean IOP change from Baseline, Hour 2 to Day 14, Hour 2 (the timepoint for the peak effect of Timolol 0.5%) was compared between WB007 0.4% and Timolol 0.5%.||0.89|-1.73|0.520
70991707|NCT04149899|141491310|NON_INFERIORITY|A pairwise treatment group comparison was performed versus timolol ophthalmic solution 0.5%. A 2-sided 95% confidence interval (CI) for the treatment difference (WB007 minus Timolol) was constructed based on an ANCOVA model. If WB007 was determined to be non-inferior to Timolol, an attempt to show superiority of WB007 over Timolol was made.|Mean Difference (Final Values)|0.14||||0.828|TWO_SIDED|95.0|-1.16|1.43||The p-value (2-sided) for superiority was not adjusted for multiple comparisons.|ANCOVA||The estimated treatment difference is based on the least-square means from the ANCOVA model.|The mean IOP for WB007 0.15% was compared to Timolol 0.5% at Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5% and the primary efficacy timepoint for the study.||1.43|-1.16|0.828
70991708|NCT04149899|141491310|NON_INFERIORITY|A pairwise treatment group comparison was performed versus timolol ophthalmic solution 0.5%. A 2-sided 95% confidence interval (CI) for the treatment difference (WB007 minus Timolol) was constructed based on an ANCOVA model. If WB007 was determined to be non-inferior to Timolol, an attempt to show superiority of WB007 over Timolol was made.|Mean Difference (Final Values)|-0.42||||0.52|TWO_SIDED|95.0|-1.73|0.89||The p-value (2-sided) for superiority was not adjusted for multiple comparisons.|ANCOVA||The estimated treatment difference is based on the least-square means from the ANCOVA model.|The mean IOP for WB007 0.4% was compared to Timolol 0.5% at Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5% and the primary efficacy timepoint for the study.||0.89|-1.73|0.520
70991709|NCT04149899|141491310|NON_INFERIORITY|A pairwise treatment group comparison was performed versus timolol ophthalmic solution 0.5%. A 2-sided 95% confidence interval (CI) for the treatment difference (WB007 minus Timolol) was constructed based on an ANOVA model. If WB007 was determined to be non-inferior to Timolol, an attempt to show superiority of WB007 over Timolol was made.|Mean Difference (Final Values)|-0.84||||0.283|TWO_SIDED|95.0|-2.39|0.71||The p-value (2-sided) for superiority was not adjusted for multiple comparisons.|ANOVA|The ANOVA model has the treatment group as the main effect.|The estimated treatment difference is based on the least-square means from the ANOVA model.|The mean IOP for WB007 0.15% was compared to Timolol 0.5% at Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5% and the primary efficacy timepoint for the study.||0.71|-2.39|0.283
70991710|NCT04149899|141491310|NON_INFERIORITY|A pairwise treatment group comparison was performed versus timolol ophthalmic solution 0.5%. A 2-sided 95% confidence interval (CI) for the treatment difference (WB007 minus Timolol) was constructed based on an ANOVA model. If WB007 was determined to be non-inferior to Timolol, an attempt to show superiority of WB007 over Timolol was made.|Mean Difference (Final Values)|-1.02||||0.189|TWO_SIDED|95.0|-2.56|0.52||The p-value (2-sided) for superiority was not adjusted for multiple comparisons.|ANOVA|The ANOVA model has the treatment group as the main effect.|The estimated treatment difference is based on the least-square means from the ANOVA model.|The mean IOP for WB007 0.4% was compared to Timolol 0.5% at Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5% and the primary efficacy timepoint for the study.||0.52|-2.56|0.189
70991711|NCT04322994|141491319|OTHER|||||||0.18||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|Chi-squared test of independence||Analysis of between-group difference for participants with any desaturation event.||||0.18
70991712|NCT04322994|141491319|OTHER|||||||0.26||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|Chi-squared test of independence||Analysis of between-group difference for participants with 1 desaturation event versus 2 or more events.||||0.26
70991713|NCT04322994|141491320|OTHER|||||||0.26||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|Chi-squared test of independence||Analysis of between-group difference for participants with at any qualifying desaturation event.||||0.26
70991714|NCT04322994|141491320|OTHER|||||||0.08||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|Chi-squared test of independence||Analysis of between-group difference for participants with 1 qualifying desaturation event versus 2 or more qualifying events.||||0.08
70991715|NCT04322994|141491321|OTHER|||||||0.28|||||||Chi-squared|||Analysis of between-group difference for participants with any qualifying event.||||0.28
70991716|NCT04322994|141491321|OTHER|||||||0.38||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|||Analysis of between-group difference for participants with 1 qualifying event versus 2 or more events.||||0.38
70991717|NCT04322994|141491322|OTHER|||||||0.88||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Analysis of between-group difference for participants with at any qualifying desaturation event.||||0.88
70991718|NCT04322994|141491323|OTHER|||||||0.14||||||The a priori threshold for statistical significance was 0.05.|Chi-squared, Corrected|Chi-squared test of independence||Analysis of between-group difference for participants with any surgical interruption.||||0.14
70991719|NCT04322994|141491323|OTHER|||||||0.21||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|Chi-squared test of independence||Analysis of between-group difference for participants with 1 surgical interruption versus 2 or more interruptions.||||0.21
70991720|NCT03664193|141491330|OTHER|Simple descriptive feasibility proportion and exact 95% confidence interval for radiation dose of 37.5 Gy.|Proportion (percent)|30.0|||||TWO_SIDED|95.0|14.7|49.3||||||||49.3|14.7|
70991721|NCT03664193|141491330|OTHER|Simple descriptive feasibility proportion and exact 95% confidence interval for radiation dose of 40.0 Gy.|Proportion (percent)|46.7|||||TWO_SIDED|95.0|28.3|65.7||||||||65.7|28.3|
70991722|NCT03664193|141491330|OTHER|Simple descriptive feasibility proportion and exact 95% confidence interval for radiation dose of 42.5 Gy.|Proportion (percent)|6.7|||||TWO_SIDED|95.0|0.8|22.1||||||||22.1|0.8|
70991723|NCT03664193|141491330|OTHER|Simple descriptive feasibility proportion and exact 95% confidence interval for radiation dose of 45.0 Gy.|Proportion (percent)|16.7|||||TWO_SIDED|95.0|5.6|34.7||||||||34.7|5.6|
70991724|NCT03664193|141491331|OTHER|Simple proportion and exact 95% confidence interval.|Proportion (percent)|100.0|||||TWO_SIDED|95.0|88.4|100.0||||||||100.0|88.4|
70991725|NCT02345252|141491335|NON_INFERIORITY|A sample size of 275 HIV-1 infected participants per treatment group would provide 85% power to detect a noninferiority margin of 8% in the Week 48 response rate difference between the FTC/RPV/TAF group and FTC/RPV/TDF group. For sample size and power computation, it is assumed that both treatment groups will have a response rate of 89% (based on Gilead Study GS-US-292-0109), that a noninferiority margin is 8%, and that the significance level of the test is at a one-sided alpha level of 0.025.|Difference in Percentages|-0.3|||||TWO_SIDED|95.001|-4.2|3.7|||||The difference in percentages and its 95.001% confidence interval (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The null hypothesis was that the percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 in the FTC/RPV/TAF group was at least 8% lower than the rate in the FTC/RPV/TDF group; the alternative hypothesis was that the percentage of participants with HIV-1 RNA \< 50 copies/mL in the FTC/RPV/TAF group was less than 8% lower than that in the FTC/RPV/TDF group.||3.7|-4.2|
70991726|NCT02345252|141491335|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
70991727|NCT00779324|141491349|OTHER||Difference in percents|-0.4||||0.9554|TWO_SIDED|95.0|-14.7|13.9|||Chi-squared|||||13.9|-14.7|0.9554
70991728|NCT00779324|141491350|OTHER|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
70991729|NCT00779324|141491351|OTHER||Difference in percents|10.8||||0.1662|TWO_SIDED|95.0|-4.2|25.8|||Chi-squared|||||25.8|-4.2|0.1662
70991730|NCT00779324|141491352|OTHER|||||||0.3488|||||||Wilcoxon (Mann-Whitney)|||||||0.3488
70991731|NCT00779324|141491354|OTHER||Difference in percents|6.4||||0.38|TWO_SIDED|95.0|-7.2|20.0|||Chi-squared|||||20|-7.2|0.38
70991732|NCT00779324|141491355|OTHER||Difference in percents|11.7||||0.1373|TWO_SIDED|95.0|-3.3|26.7|||Chi-squared|||||26.7|-3.3|0.1373
70991733|NCT00779324|141491356|OTHER|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
70991734|NCT00779324|141491357|OTHER|||||||0.0353|||||||Wilcoxon (Mann-Whitney)|||||||0.0353
70991735|NCT02913222|141491361|OTHER|||||||1||||||The threshold for statistical significance was set at p = 0.05.|Fisher Exact|||A priori criteria for success was that we would achieve 90% adherence to attending treatment sessions. Fisher's exact test compared patient adherence to treatment session rates by site and by group.||||1.0
70991736|NCT02913222|141491362|OTHER|The purpose of this study was to determine preliminary estimates of the effect of movement pattern training and standard rehabilitation on patient-reported function.|Mean Difference (Final Values)|-2.2||||0.32|TWO_SIDED|95.0|-6.51|2.11||The threshold for statistical significance was p = 0.05|ANCOVA|||We hypothesized MPT would demonstrate greater improvement in HOOS compared to Standard. Data collected at pretest and posttest were analyzed with ANCOVA where posttest was the dependent variable, pretest was the covariate, and treatment group was the independent variable which tests the null hypothesis that after adjusting for pretest, posttest is not significantly different across treatment groups.||2.11|-6.51|0.32
71039304|NCT03969641|141586445|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|1.01||||1|TWO_SIDED|95.0|0.2|5.04|||Mantel Haenszel|||Chills/Shivering||5.04|0.20|1.0000
70991737|NCT02913222|141491363|OTHER|The purpose of this study was to determine preliminary estimates of the effect of movement pattern training and standard rehabilitation on patient-reported function.|Mean Difference (Final Values)|-5.55||||0.14|TWO_SIDED|95.0|-13.1|1.99||The threshold for statistical significance was p = 0.05.|ANCOVA|||We hypothesized MPT would demonstrate greater improvement in HOOS compared to Standard. Data collected at pretest and posttest were analyzed with ANCOVA where posttest was the dependent variable, pretest was the covariate, and treatment group was the independent variable which tests the null hypothesis that after adjusting for pretest, posttest is not significantly different across treatment groups.||1.99|-13.10|0.14
70991738|NCT01496430|141491404|SUPERIORITY_OR_OTHER|||||||0.007||||||Sequential testing was used to control for multiple comparisons. Azilsartan medoxomil 80 mg was first compared to placebo and if p-value ≤0.05 then azilsartaon medoxomil 40 mg was compared to placebo.|ANCOVA|||||||0.007
71098846|NCT00987935|141706304|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.213|||||TWO_SIDED|95.0|0.73|2.014|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||2.014|0.730|
71098847|NCT00987935|141706308|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.186|||||TWO_SIDED|95.0|0.728|1.932|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||1.932|0.728|
71098848|NCT00987935|141706309|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.593|1.489|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||1.489|0.593|
71098849|NCT02222181|141706319|SUPERIORITY_OR_OTHER|||||||0.23|||||||t-test, 1 sided|||||||0.23
71098850|NCT02222181|141706320|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
70991739|NCT01496430|141491404|SUPERIORITY_OR_OTHER|||||||0.067||||||Sequential testing was used to control for multiple comparisons. Azilsartan medoxomil 80 mg was first compared to placebo and if p-value ≤0.05 then azilsartaon medoxomil 40 mg was compared to placebo.|ANCOVA|||||||0.067
70991740|NCT01496430|141491405|SUPERIORITY_OR_OTHER|||||||0.86||||||Sequential testing was used to control for multiple comparisons. Azilsartan medoxomil 80 mg was first compared to placebo and if p-value ≤0.05 then azilsartaon medoxomil 40 mg was compared to placebo.|ANCOVA|||||||0.860
71098851|NCT02222181|141706321|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 1 sided|||||||0.03
71098852|NCT02222181|141706322|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71098853|NCT02222181|141706323|SUPERIORITY_OR_OTHER|||||||0.025|||||||t-test, 1 sided|||||||0.025
71098854|NCT02222181|141706324|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71098855|NCT02222181|141706325|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
71098856|NCT00345592|141706330|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.987|||||TWO_SIDED|95.0|0.684|1.503||||||||1.503|0.684|
70991741|NCT01496430|141491405|SUPERIORITY_OR_OTHER|||||||0.21||||||Sequential testing was used to control for multiple comparisons. Azilsartan medoxomil 80 mg was first compared to placebo and if p-value ≤0.05 then azilsartaon medoxomil 40 mg was compared to placebo.|ANCOVA|||||||0.210
70991742|NCT01100307|141491427|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.85||||0.0003|TWO_SIDED|95.0|1.92|12.28||Significance level of test in the comparison between pegaptanib sodium 0.3 mg and sham was set to 0.05.|Cochran-Mantel-Haenszel|Stratification factors (HbA1c and baseline visual acuity categories)||The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.||12.28|1.92|0.0003
70991743|NCT01100307|141491428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.52||||0.0006|TWO_SIDED|95.0|1.1|3.94||Significance level of test in the comparison between pegaptanib sodium 0.3 mg and sham was set to 0.05.|ANCOVA|Based on an analysis of covariance with treatment as a factor and stratification factors (HbA1c and baseline visual acuity categories) as covariates.||Comparison at Week 6: The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.||3.94|1.10|0.0006
70991744|NCT01100307|141491428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.69||||0.0001|TWO_SIDED|95.0|1.81|5.58||Significance level of test in the comparison between pegaptanib sodium 0.3 mg and sham was set to 0.05.|ANCOVA|Based on an analysis of covariance with treatment as a factor and stratification factors (HbA1c and baseline visual acuity categories) as covariates.||Comparison at Week 12: The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.||5.58|1.81|0.0001
71098857|NCT01245049|141706386|NON_INFERIORITY|To assess the Non-inferiority of the Boostrix Polio Group compared to the Repevax Group in terms of booster response to diphtheria, standardized asymptotic 95% CI for the groups'difference \[Repevax Group minus Boostrix Polio Group\] was computed. Non-inferiority criterion: Upper limit of the 95% CI of the groups' difference in booster response rate ≤10%.|Percentage difference|0.56|||||TWO_SIDED|95.0|-3.55|3.14|||Standardized asymptotic|||Non-inferiority in terms of booster response to D||3.14|-3.55|
71098858|NCT01245049|141706386|NON_INFERIORITY|To assess the Non-inferiority of the Boostrix Polio Group compared to the Repevax Group in terms of booster response to tetanus, standardized asymptotic 95% CI for the groups' difference \[Repevax Group minus Boostrix Polio Group\] was computed. Non-inferiority criterion: Upper limit of the 95% CI of the groups' difference in booster response rate ≤10%.|Percentage difference|1.7|||||TWO_SIDED|95.0|-2.43|4.9||||||Non-inferiority in terms of booster response to T||4.9|-2.43|
71098859|NCT01245049|141706388|NON_INFERIORITY|Criterion for evaluation of the corresponding objective: Upper limit (UL) of the 95% confidence interval (CI) on the GMT ratio for the groups' (Repevax Group divided by Boostrix-Polio Group) was lower than or equal to (≤) 2.|Difference in adjusted GMT ratio|0.91|||||TWO_SIDED|95.0|0.65|1.28|||ANCOVA|||Immune response difference to anti-Polio 1 antigen||1.28|0.65|
71098860|NCT01245049|141706388|NON_INFERIORITY|Criterion for evaluation of the corresponding objective: UL of the 95% CI on the GMT ratio for the groups' (Repevax Group divided by Boostrix-Polio Group) ≤ 2.|Difference in adjusted GMT ratio|0.78|||||TWO_SIDED|95.0|0.54|1.12|||ANCOVA|||Immune response difference to anti-Polio 2 antigen||1.12|0.54|
70991745|NCT01100307|141491428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.65||||0.0096|TWO_SIDED|95.0|0.65|4.65||Significance level of test in the comparison between pegaptanib sodium 0.3 mg and sham was set to 0.05.|ANCOVA|Based on an analysis of covariance with treatment as a factor and stratification factors (HbA1c and baseline visual acuity categories) as covariates.||Comparison at Week 18: The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.||4.65|0.65|0.0096
70991746|NCT01100307|141491428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.26|||<|0.0001|TWO_SIDED|95.0|2.19|6.32||Significance level of test in the comparison between pegaptanib sodium 0.3 mg and sham was set to 0.05.|ANCOVA|Based on an analysis of covariance with treatment as a factor and stratification factors (HbA1c and baseline visual acuity categories) as covariates.||Comparison at Week 24: The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.||6.32|2.19|<0.0001
70991747|NCT02196038|141491457|SUPERIORITY||Mean Difference (Final Values)|1.5|||<|0.0001|TWO_SIDED|95.0|0.9|2.0|||joint model|Joint model of ANCOVA plus survival||||2.0|0.9|<0.0001
70991748|NCT02196038|141491458|SUPERIORITY||Rate Ratio|0.93||||0.59|TWO_SIDED|95.0|0.66|1.19|||Joint Model|Joint model of Poisson regression and survival||||1.19|0.66|0.59
70991749|NCT04436822|141491519|SUPERIORITY||Intercept from ANCOVA as agreement rate|88.9|||<|0.05|TWO_SIDED|90.0|87.1|90.7|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).||||90.7|87.1|<0.05
71039305|NCT03969641|141586445|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|0.0||The upper limit of this CI is infinity, thus no numeric value can be provided.||Mantel Haenszel|||Body Rash|||0.00|1.0000
71039306|NCT03969641|141586445|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.92||||1|TWO_SIDED|95.0|0.39|2.15|||Mantel Haenszel|||Malaise (Fatigue)||2.15|0.39|1.0000
70923149|NCT06023082|141337587|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
70991750|NCT04436822|141491519|SUPERIORITY||Intercept from ANCOVA as agreement rate|87.5|||<|0.05|TWO_SIDED|90.0|85.4|89.7|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).||||89.7|85.4|<0.05
70991751|NCT04436822|141491519|SUPERIORITY||Intercept from ANCOVA as agreement rate|87.9|||<|0.05|TWO_SIDED|90.0|85.8|89.9|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).||||89.9|85.8|<0.05
70991752|NCT00369668|141491525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.0|STANDARD_ERROR_OF_MEAN|3.65|<|0.05|TWO_SIDED|95.0|22.5|37.4|||Mixed Models Analysis|Greenhouse-Geisser degrees of freedom adjustment was not necessary.||Group by Test Session ANOVA with repeated measures on second factor.||37.4|22.5|<0.05
70991753|NCT01079962|141491575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.701||||0.5943|TWO_SIDED|95.0|-1.89|3.29||No adjustment of p-value was done and priori threshold was 0.05.|t-test, 2 sided|||Change in APP at Week 12: p-value was calculated by 2 sided t-test.||3.29|-1.89|0.5943
70991754|NCT01079962|141491576|SUPERIORITY_OR_OTHER|||||||0.8589||95.0|||||t-test, 2 sided|||Change in SBP at Week 4: p-value was calculated by 2 sided t-test.||||0.8589
70991755|NCT01079962|141491576|SUPERIORITY_OR_OTHER|||||||0.2223||95.0|||||t-test, 2 sided|||Change in SBP at Week 12: p-value was calculated by 2 sided t-test.||||0.2223
70991756|NCT01079962|141491576|SUPERIORITY_OR_OTHER|||||||0.2443||95.0|||||t-test, 2 sided|||Change in DBP at Week 4: p-value was calculated by 2 sided t-test.||||0.2443
70991757|NCT01079962|141491576|SUPERIORITY_OR_OTHER|||||||0.1481||95.0|||||t-test, 2 sided|||Change in DBP at Week 12: p-value was calculated by 2 sided t-test.||||0.1481
70991758|NCT01079962|141491576|SUPERIORITY_OR_OTHER|||||||0.4188||95.0|||||t-test, 2 sided|||Change in mean BP at Week 4: p-value was calculated by 2 sided t-test.||||0.4188
70991759|NCT01079962|141491576|SUPERIORITY_OR_OTHER|||||||0.1586||95.0|||||t-test, 2 sided|||Change in mean BP at Week 12: p-value was calculated by 2 sided t-test.||||0.1586
70991760|NCT01079962|141491577|SUPERIORITY_OR_OTHER|||||||0.2987||95.0|||||t-test, 2 sided|||Change in AIx at Week 4: p-value was calculated by 2 sided t-test.||||0.2987
70991761|NCT01079962|141491577|SUPERIORITY_OR_OTHER|||||||0.6584||95.0|||||t-test, 2 sided|||Change in AIx at Week 12: p-value was calculated by 2 sided t-test.||||0.6584
70991762|NCT01079962|141491578|SUPERIORITY_OR_OTHER|||||||0.2511||95.0|||||t-test, 2 sided|||Change in cfPWV at Week 4: p-value was calculated by 2 sided t-test.||||0.2511
70991763|NCT01079962|141491578|SUPERIORITY_OR_OTHER|||||||0.5007||95.0|||||t-test, 2 sided|||Change in cfPWV at Week 12: p-value was calculated by 2 sided t-test.||||0.5007
70991764|NCT01079962|141491579|SUPERIORITY_OR_OTHER|||||||0.9943||95.0|||||t-test, 2 sided|||Change in heart rate at Week 4: p-value was calculated by 2 sided t-test.||||0.9943
70991765|NCT01079962|141491579|SUPERIORITY_OR_OTHER|||||||0.523||95.0|||||t-test, 2 sided|||Change in heart rate at Week 12: p-value was calculated by 2 sided t-test.||||0.5230
71039307|NCT03969641|141586445|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.87||||1|TWO_SIDED|95.0|0.31|2.48|||Mantel Haenszel|||Myalgia (Body Aches)||2.48|0.31|1.0000
71039308|NCT03969641|141586445|SUPERIORITY||Odds Ratio (OR)|0.71||||0.7704|TWO_SIDED|95.0|0.22|2.29|||Mantel Haenszel|||Joint Pain||2.29|0.22|0.7704
70991766|NCT01079962|141491580|SUPERIORITY_OR_OTHER|||||||0.4447||95.0|||||t-test, 2 sided|||||||0.4447
70991767|NCT01079962|141491581|SUPERIORITY_OR_OTHER|||||||0.396||95.0|||||t-test, 2 sided|||Change in Total cholesterol at Week 12: p-value was calculated by 2 sided t-test.||||0.3960
71098861|NCT01245049|141706388|NON_INFERIORITY|Criterion for evaluation of the corresponding objective: UL of the 95% CI on the GMT ratio for the groups' (Repevax Group divided by Boostrix-Polio Group) ≤ 2.|Difference in adjusted GMT ratio|1.3|||||TWO_SIDED|95.0|0.93|1.84|||ANCOVA|||Immune response difference to anti-Polio 3 antigen||1.84|0.93|
70991768|NCT01079962|141491581|SUPERIORITY_OR_OTHER|||||||0.1919||95.0|||||t-test, 2 sided|||Change in LDL-cholesterol at Week 12: p-value was calculated by 2 sided t-test.||||0.1919
70991769|NCT01079962|141491581|SUPERIORITY_OR_OTHER|||||||0.1896||95.0|||||t-test, 2 sided|||Change in HDL-cholesterol at Week 12: p-value was calculated by 2 sided t-test.||||0.1896
70991770|NCT01079962|141491582|SUPERIORITY_OR_OTHER|||||||0.9244||95.0|||||t-test, 2 sided|||||||0.9244
70991771|NCT01079962|141491583|SUPERIORITY_OR_OTHER|||||||0.9692||95.0|||||t-test, 2 sided|||Change in SBP at Week 4: p-value was calculated by 2 sided t-test.||||0.9692
70991772|NCT01079962|141491583|SUPERIORITY_OR_OTHER|||||||0.4731||95.0|||||t-test, 2 sided|||Change in SBP at Week 12: p-value was calculated by 2 sided t-test.||||0.4731
70991773|NCT01079962|141491583|SUPERIORITY_OR_OTHER|||||||0.2876||95.0|||||t-test, 2 sided|||Change in DBP at Week 4: p-value was calculated by 2 sided t-test.||||0.2876
70991774|NCT01079962|141491583|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||t-test, 2 sided|||Change in DBP at Week 12: p-value was calculated by 2 sided t-test.||||0.0420
70991775|NCT01079962|141491583|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||t-test, 2 sided|||Change in mean BP at Week 4: p-value was calculated by 2 sided t-test.||||0.5100
70991776|NCT01079962|141491583|SUPERIORITY_OR_OTHER|||||||0.1207||95.0|||||t-test, 2 sided|||Change in mean BP at Week 12: p-value was calculated by 2 sided t-test.||||0.1207
70991777|NCT01079962|141491585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.442||||0.7561||95.0|-2.36|3.24||No adjustment of p-value was done and priori threshold was 0.05.|t-test, 2 sided|||||3.24|-2.36|0.7561
70991778|NCT01008995|141491616|SUPERIORITY_OR_OTHER||||||<|0.001||||||The study was designed to maintain a Type I error of 0.05 or less for the primary analysis.|Cochran-Mantel-Haenszel|Stratified by baseline weight \[≤ 65kg vs \> 65 kg)\].||Null Hypothesis: No difference between ustekinumab 45 mg and placebo for the primary endpoint at a significance level of 0.05. Power calculations were based on two sample size assumptions: 220 (1:1 ratio) and 320 participants (1:1 ratio). Simulation studies evaluated the power to detect a treatment difference between ustekinumab 45 mg group and placebo using a CMH test stratified by baseline weight \[\<=65 kg vs \> 65 kg). The power was \>99% for both sample size assumptions.||||<0.001
70991779|NCT01008995|141491617|SUPERIORITY_OR_OTHER||||||<|0.001||||||No multiplicity adjustment was made and nominal p-value was reported.|Cochran-Mantel-Haenszel|Stratified by baseline weight \[≤ 65kg vs \> 65 kg)\].||Null Hypothesis: No difference between ustekinumab 45 mg and placebo at a significance level of 0.05.||||<0.001
70991780|NCT01008995|141491618|SUPERIORITY_OR_OTHER||||||<|0.001||||||No multiplicity adjustment was made and nominal p-value was reported.|ANOVA|Analysis of variance on van der Waerden normal scores (Conover, 1980) with treatment and baseline weight (≤ 65kg vs \> 65 kg) as factors in the model.||Null Hypothesis: No difference between ustekinumab 45 mg and placebo at a significance level of 0.05.||||<0.001
70991781|NCT00406640|141491619|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.67||||0.243||95.0|-0.46|1.81|||Mixed Models Analysis|Mixed Models Repeated Measures (MMRM) with baseline score as a covariant and factors for center, week and treatment.|DVS SR adjusted mean change minus ESC adjusted mean change.|DVS SR compared with ESC||1.81|-0.46|0.243
70991782|NCT00406640|141491620|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.608||||0.077||95.0|0.4|0.92|||Chi-squared|Logistic regression model with treatment and site as factors and baseline score as a covariant.|Estimated odds ratio of DVS SR to ESC. Odd ratio adjusted for baseline, treatment and site.|DVS SR compared with ESC.||0.92|0.40|0.077
70991783|NCT00406640|141491621|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.571||||0.0054||95.0|0.39|0.85|||Chi-squared|Logistic regression model with treatment and site as factors and baseline score as a covariant.|Estimated odds ratio of DVS SR to ESC. Odds ratio adjusted for baseline, treatment and site.|DVS SR compared with ESC.||0.85|0.39|0.0054
70991784|NCT00406640|141491622|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12||||0.26||95.0|-0.09|0.33|||Mixed Models Analysis|Mixed Models Repeated Measures (MMRM) with baseline score as a covariant and factors for center, week and treatment.|DVS SR minus ESC adjusted mean|DVS SR compared with ESC||0.33|-0.09|0.260
70991785|NCT00406640|141491623|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14||||0.239||95.0|-0.09|0.37|||Mixed Models Analysis|Mixed Models Repeated Measures (MMRM) with baseline score as a covariant and factors for center, week and treatment.|DVS SR minus ESC adjusted mean|||0.37|-0.09|0.239
70991786|NCT00406640|141491624|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.37||||0.516||95.0|-0.75|1.49|||Mixed Models Analysis|Mixed model Repeated Measures (MMRM) analysis adjusted mean score for baseline score, time and center.|DVS SR adjusted mean change minus ESC adjusted mean change.|DVS SR compared to ESC||1.49|-0.75|0.516
70991787|NCT00406640|141491625|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.01||||0.635||95.0|-0.03|0.06|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) with treatment, time and site as factors and baseline as covariant.|DVS SR adjusted mean change minus ESC adjusted mean change|DVS SR compared to ESC||0.06|-0.03|0.635
71039309|NCT01541215|141586446|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 1: Primary analysis: change from baseline to week 26 in HbA1c~Superiority of liraglutide over placebo was to be concluded if the 95% confidence interval for the treatment difference for change from baseline in HbA1c (%) after 26 weeks of randomised treatment was entirely below 0%, implying that the two sided p-value was less than 5%."|Treatment difference|-1.058|STANDARD_ERROR_OF_MEAN|0.304|<|0.001|TWO_SIDED|95.0|-1.653|-0.464|||Pattern Mixture Model|||Analysis using a pattern mixture model of observed data with missing observations imputed from the placebo arm based on multiple (x10.000) imputations. The data for week 26 were then analysed with an ANCOVA model containing treatment, sex and age group as fixed effects and baseline value as covariate. The estimated treatment differences and confidence intervals were combined using Rubins formula.||-0.464|-1.653|<0.001
71039310|NCT01541215|141586447|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 2: Change from baseline in FPG after 26 weeks of treatment"|Treatment difference|-1.878|STANDARD_ERROR_OF_MEAN|0.62||0.002|TWO_SIDED|95.0|-3.093|-0.662|||Pattern Mixture Model|||Analysis using a pattern mixture model of observed data with missing observations imputed from the placebo arm based on multiple (x10.000) imputations. The data for weeks 26 were then analysed with an ANCOVA model containing treatment, sex and age group as fixed effects and baseline value as covariate. The estimated treatment differences and confidence intervals were combined using Rubins formula.||-0.662|-3.093|0.002
71039311|NCT01541215|141586448|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 3: HbA1c \< 7.0% after 26 weeks of treatment"|Treatment odds ratio|5.353|||<|0.001|TWO_SIDED|95.0|2.105|13.615|||logistic regression model|||Missing data was imputed using pattern mixture model. For each imputed data set the binary response was analysed in a logistic regression model using a logit link with treatment and stratification group (gender\*age group) as fixed factors and baseline HbA1c as covariate.The estimated treatment effects and confidence intervals were combined using Rubin´s formula.||13.615|2.105|<0.001
71039312|NCT01541215|141586449|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 4: Change from baseline in BMI SDS after 26 weeks of treatment"|Treatment difference|-0.047|STANDARD_ERROR_OF_MEAN|0.055||0.392|TWO_SIDED|95.0|-0.153|0.06|||Pattern Mixture Model|||Analysis using a pattern mixture model of observed data with missing observations imputed from the placebo arm based on multiple (x10.000) imputations. The data for weeks 26 were then analysed with an ANCOVA model containing treatment, sex and age group as fixed effects and baseline value as covariate. The estimated treatment differences and confidence intervals were combined using Rubins formula.||0.060|-0.153|0.392
71039313|NCT02466087|141586542|OTHER||diiference in differences|1.5|||||TWO_SIDED|95.0|||||Regression, Linear|||||||
71039314|NCT00452348|141586623|SUPERIORITY_OR_OTHER||Least Squares Mean|0.04||||0.09||95.0|-0.01|0.09|||ANCOVA|||||0.09|-0.01|0.090
71039315|NCT02725515|141586637|SUPERIORITY||Risk Difference (RD)|13.4||||0.183|TWO_SIDED|95.0|-6.6|32.6|||Barnard's Unconditional Exact Test P-val|||||32.6|-6.6|0.1830
71039316|NCT02725515|141586638|SUPERIORITY||Risk Difference (RD)|17.5||||0.1075|TWO_SIDED|95.0|-3.7|37.3|||Barnard's Unconditional Exact Test P-val|||||37.3|-3.7|0.1075
71039317|NCT02725515|141586639|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0252|TWO_SIDED|95.0|0.3|0.92|||Log Rank|||||0.92|0.30|0.0252
71039318|NCT02898740|141586655|OTHER||Mean Difference (Net)|-3.4|STANDARD_ERROR_OF_MEAN|1.7|<|0.05|TWO_SIDED|95.0|-6.8|0.0|||Mixed Models Analysis|models were adjusted for age|treatment difference = Exercise - Health Education|||-0.0|-6.8|<0.05
71039319|NCT01513239|141586691|SUPERIORITY_OR_OTHER||Adjusted Difference|-10.7|||<|0.0001|TWO_SIDED|95.0|-16.4|-5.1||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC|||-5.1|-16.4|<0.0001
71039320|NCT01513239|141586691|SUPERIORITY_OR_OTHER||Adjusted Difference|-9.9||||0.0003|TWO_SIDED|95.0|-15.5|-4.3||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||-4.3|-15.5|0.0003
70923150|NCT06023082|141337588|OTHER|||||||0.4907||||||Baseline to Week 12 comparison.|ANOVA|||||||0.4907
70923151|NCT06023082|141337589|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
71039321|NCT01513239|141586691|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.8||||0.3718|TWO_SIDED|95.0|-5.9|4.2||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus MK-6072 + SOC|||4.2|-5.9|0.3718
71039322|NCT01513239|141586692|SUPERIORITY_OR_OTHER||Adjusted Difference|5.2||||0.0722|TWO_SIDED|95.0|-1.8|12.2||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC|||12.2|-1.8|0.0722
71039323|NCT01513239|141586692|SUPERIORITY_OR_OTHER||Adjusted Difference|14.6|||<|0.0001|TWO_SIDED|95.0|7.7|21.4||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||21.4|7.7|<0.0001
71039324|NCT01513239|141586692|SUPERIORITY_OR_OTHER||Adjusted Difference|-9.4||||0.9969|TWO_SIDED|95.0|-16.1|-2.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus MK-6072 + SOC|||-2.7|-16.1|0.9969
71039325|NCT01513239|141586693|SUPERIORITY_OR_OTHER||Adjusted Difference|-11.9||||0.0006|TWO_SIDED|95.0|-19.0|-4.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC|||-4.7|-19.0|0.0006
71039326|NCT01513239|141586693|SUPERIORITY_OR_OTHER||Adjusted Difference|-13.7|||<|0.0001|TWO_SIDED|95.0|-20.4|-6.9||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||-6.9|-20.4|<0.0001
70991788|NCT00406640|141491626|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.702||95.0|0.63|2.0|||Chi-squared||Estimated odds ratio of DVS SR to ESC. Odd ratio adjusted for baseline, treatment and site.|DVS SR compared with ESC.||2.00|0.63|0.702
70991789|NCT00406640|141491627|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.34||||0.234||95.0|0.83|2.16|||Chi-squared||Estimated odds ratio of DVS SR to ESC. Odd ratio adjusted for baseline, treatment and site.|DVS SR compared with ESC.||2.16|0.83|0.234
70991790|NCT00406640|141491631|SUPERIORITY_OR_OTHER_LEGACY|||||||0.927||95.0|||||t-test, 2 sided|||DVS SR vs. ESC: end of therapy||||0.927
70991791|NCT00406640|141491631|SUPERIORITY_OR_OTHER_LEGACY|||||||0.055||95.0|||||t-test, 2 sided|||DVS SR vs. ESC: after 1 week of taper||||0.055
70991792|NCT00406640|141491631|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025||95.0|||||t-test, 2 sided|||DVS SR vs. ESC: after 2 weeks of taper||||0.025
70991793|NCT00406640|141491631|SUPERIORITY_OR_OTHER_LEGACY|||||||0.653||95.0|||||t-test, 2 sided|||DVS SR vs. ESC: after \> 2 weeks of taper||||0.653
70923152|NCT06023082|141337590|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
70991794|NCT01670656|141491655|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.6|||<|0.001|TWO_SIDED|95.0|-1.0|-0.2|||cLDA|||||-0.2|-1.0|< 0.001
70991795|NCT01670656|141491655|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.6|||<|0.001|TWO_SIDED|95.0|-0.9|-0.2|||cLDA|||||-0.2|-0.9|< 0.001
70991796|NCT01670656|141491655|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.8|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4|||cLDA|||||-0.4|-1.1|< 0.001
70991797|NCT01670656|141491655|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.5|||<|0.001|TWO_SIDED|95.0|-0.9|-0.2|||cLDA|||||-0.2|-0.9|< 0.001
70991798|NCT01670656|141491656|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-1.7|||=|0.002|TWO_SIDED|95.0|-3.0|-0.4|||cLDA|||||-0.4|-3.0|= 0.002
70991799|NCT01670656|141491656|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-1.9|||<|0.001|TWO_SIDED|95.0|-3.1|-0.6|||cLDA|||||-0.6|-3.1|< 0.001
70991800|NCT01670656|141491656|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-1.6|||=|0.003|TWO_SIDED|95.0|-2.9|-0.3|||cLDA|||||-0.3|-2.9|= 0.003
70991801|NCT01670656|141491656|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-1.2|||=|0.024|TWO_SIDED|95.0|-2.5|0.1|||cLDA|||||0.1|-2.5|= 0.024
70991802|NCT01670656|141491657|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-1.6|||=|0.026|TWO_SIDED|95.0|-3.4|0.2|||cLDA|||||0.2|-3.4|= 0.026
70991803|NCT01670656|141491657|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-1.5|||=|0.036|TWO_SIDED|95.0|-3.3|0.2|||cLDA|||||0.2|-3.3|= 0.036
70991804|NCT01670656|141491657|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-2.3|||=|0.002|TWO_SIDED|95.0|-4.1|-0.5|||cLDA|||||-0.5|-4.1|= 0.002
70991805|NCT01670656|141491657|SUPERIORITY_OR_OTHER_LEGACY||Diffference in Least Squares Means|-1.2|||=|0.1|TWO_SIDED|95.0|-3.0|0.6|||cLDA|||||0.6|-3.0|= 0.1
70991806|NCT01670656|141491658|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.1|||=|0.447|TWO_SIDED|95.0|-0.6|0.3|||cLDA|||||0.3|-0.6|= 0.447
70991807|NCT01670656|141491658|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.6|||=|0.003|TWO_SIDED|95.0|-1.0|-0.1|||cLDA|||||-0.1|-1.0|= 0.003
70991808|NCT01670656|141491658|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.6|||=|0.003|TWO_SIDED|95.0|-1.0|-0.1|||cLDA|||||-0.1|-1.0|= 0.003
70991809|NCT01670656|141491658|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.3|||=|0.156|TWO_SIDED|95.0|-0.7|0.2|||cLDA|||||0.2|-0.7|= 0.156
70991810|NCT01000727|141491680|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.929|TWO_SIDED|95.02|0.91|1.09||Statistical significance of this p-value is based on the alpha-spending function of this study.|Cox Proportional Hazard Regression Model|||||1.09|0.91|0.929
70991811|NCT01000727|141491681|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.777|TWO_SIDED|95.02|0.9|1.09||Statistical significance of this p-value is based on the alpha-spending function of this study.|Cox Proportional Hazard Regression Model|||||1.09|0.90|0.777
70991812|NCT01000727|141491682|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.274|TWO_SIDED|95.0|0.76|1.08||Statistical significance of this p-value is based on the alpha-spending function of this study.|Cox Proportional Hazard Regression Model|||||1.08|0.76|0.274
70991813|NCT01000727|141491683|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.631|TWO_SIDED|95.0|0.86|1.09|||Cox Proportional Hazard Regression Model||A hazard ratio \<1 indicates a lower risk with this treatment compared to Placebo|||1.09|0.86|0.631
70991814|NCT01000727|141491684|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.354|TWO_SIDED|95.0|0.88|1.42|||Cox Proportional Hazard Regression Model||A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo|||1.42|0.88|0.354
70991815|NCT01000727|141491685|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.161|TWO_SIDED|95.0|0.73|1.05|||Cox Proportional Hazard Regression Model|||||1.05|0.73|0.161
70991816|NCT01000727|141491686|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.36|TWO_SIDED|95.0|0.91|1.31|||Cox Proportional Hazard Regression Model|||||1.31|0.91|0.360
70991817|NCT01000727|141491687|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.202|TWO_SIDED|95.0|0.88|1.03|||Cox Proportional Hazard Regression Model||A hazard ratio \<1 indicates a lower risk with this treatment compared to Placebo|||1.03|0.88|0.202
70991818|NCT01000727|141491688|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.329|TWO_SIDED|95.0|0.87|1.05|||Cox Proportional Hazard Regression Model|||||1.05|0.87|0.329
70991819|NCT01000727|141491689|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.797|TWO_SIDED|95.0|0.9|1.08|||Cox Proportional Hazard Regression Model|||||1.08|0.90|0.797
70991820|NCT01000727|141491690|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.546|TWO_SIDED|95.0|0.87|1.07|||Cox Proportional Hazard Regression Model||A hazard ratio \<1 indicates a lower risk with this treatment compared to Placebo|||1.07|0.87|0.546
70991821|NCT01000727|141491691|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.362|TWO_SIDED|95.0|0.81|1.08|||Cox Proportional Hazard Regression Model|||||1.08|0.81|0.362
70991822|NCT01332019|141491747|SUPERIORITY_OR_OTHER||rate ratio|0.755||||0.0203|TWO_SIDED|95.0|0.595|0.957||q2w/q4w|negative binomial regression|||Based on negative binomial regression for each treatment group, with adjustment for EDSS (\<4 vs. \>=4), relapse rate (based on 1 year before 105MS301 and 105MS301), and age (\<40 vs. \>=40) at 105MS302 baseline.||0.957|0.595|0.0203
70923153|NCT06023082|141337591|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
70923154|NCT06023082|141337592|OTHER|||||||0.0016||||||Baseline to Week 12 comparison.|ANOVA|||||||0.0016
70991823|NCT01332019|141491748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.0201|TWO_SIDED|95.0|0.59|0.96||Based on Cox proportion hazards model, adjusted for EDSS (\<4 vs \>= 4), age (\<40 vs \>=40), relapse rate (based on one year before 105MS301 and 105MS301), and gadolinium (Gd) enhancing lesions (presence vs. absence) at 105MS302 baseline.|Cox proportion hazards model|||q2w/q4w||0.96|0.59|0.0201
70991824|NCT01332019|141491749|SUPERIORITY_OR_OTHER||lesion mean ratio|0.51|||<|0.0001|TWO_SIDED|95.0|0.41|0.63||Lesion mean ratio (95% CI) and p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on negative binomial regression, adjusted for 105MS302 baseline number of T2 lesions.|negative binomial regression|||Week 48||0.63|0.41|<0.0001
70923155|NCT06023082|141337593|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
70923156|NCT06023082|141337594|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
70923157|NCT06023082|141337595|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
70923158|NCT06023082|141337596|OTHER|||||||0.0002||||||Baseline to Week 12 comparison.|ANOVA|||||||0.0002
70923159|NCT06023082|141337597|OTHER|||||||0.001||||||Baseline to Week 12 comparison.|ANOVA|||||||0.001
70923160|NCT06023082|141337598|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
70923161|NCT06023082|141337599|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
70923162|NCT06023082|141337600|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
70923163|NCT06023082|141337601|OTHER||||||<|0.0001|||||||ANOVA|||Baseline to Week 12 comparison.||||<0.0001
70923164|NCT06023082|141337602|OTHER||||||<|0.0001||||||Baseline to Week 10 comparison.|ANOVA|||||||<0.0001
70923165|NCT06023082|141337603|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
70923166|NCT06023082|141337604|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
70923167|NCT06023082|141337605|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
70923168|NCT06023082|141337606|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
70923169|NCT05623345|141337635|SUPERIORITY||Risk Difference (RD)|36.22|STANDARD_ERROR_OF_MEAN|17.43||0.0377|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0377
70923170|NCT05623345|141337635|SUPERIORITY||Risk Difference (RD)|27.69|STANDARD_ERROR_OF_MEAN|5.68|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
70923171|NCT05623345|141337635|SUPERIORITY||Risk Difference (RD)|24.44|STANDARD_ERROR_OF_MEAN|5.65|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
70923172|NCT05623345|141337636|SUPERIORITY||Risk Difference (RD)|43.71|STANDARD_ERROR_OF_MEAN|22.14||0.0483|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0483
70923173|NCT05623345|141337636|SUPERIORITY||Risk Difference (RD)|46.15|STANDARD_ERROR_OF_MEAN|7.62|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
70923174|NCT05623345|141337636|SUPERIORITY||Risk Difference (RD)|52.8|STANDARD_ERROR_OF_MEAN|7.56|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
70923175|NCT05623345|141337637|SUPERIORITY||Risk Difference (RD)|32.26|STANDARD_ERROR_OF_MEAN|18.93||0.0883|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0883
70923176|NCT05623345|141337637|SUPERIORITY||Risk Difference (RD)|9.19|STANDARD_ERROR_OF_MEAN|8.35||0.2713|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.2713
70923177|NCT05623345|141337637|SUPERIORITY||Risk Difference (RD)|-1.2|STANDARD_ERROR_OF_MEAN|8.44||0.8872|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.8872
70923178|NCT05623345|141337638|SUPERIORITY||Risk Difference (RD)|23.45|STANDARD_ERROR_OF_MEAN|16.9||0.1654|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.1654
70923179|NCT05623345|141337638|SUPERIORITY||Risk Difference (RD)|26.58|STANDARD_ERROR_OF_MEAN|5.53|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
70923180|NCT05623345|141337638|SUPERIORITY||Risk Difference (RD)|25.84|STANDARD_ERROR_OF_MEAN|5.55|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
70923181|NCT05623345|141337639|SUPERIORITY||Risk Difference (RD)|43.09|STANDARD_ERROR_OF_MEAN|16.85||0.0106|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0106
70923182|NCT05623345|141337639|SUPERIORITY||Risk Difference (RD)|28.46|STANDARD_ERROR_OF_MEAN|6.22|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
70923183|NCT05623345|141337639|SUPERIORITY||Risk Difference (RD)|23.7|STANDARD_ERROR_OF_MEAN|6.4||0.0002|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0002
70923184|NCT05623345|141337640|SUPERIORITY||Risk Difference (RD)|30.15|STANDARD_ERROR_OF_MEAN|19.11||0.1147|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.1147
70923185|NCT05623345|141337640|SUPERIORITY||Risk Difference (RD)|29.04|STANDARD_ERROR_OF_MEAN|5.92|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
70923186|NCT05623345|141337640|SUPERIORITY||Risk Difference (RD)|24.99|STANDARD_ERROR_OF_MEAN|5.81|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
70923187|NCT05623345|141337641|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.166||0.514|TWO_SIDED|95.0|-0.22|0.44|||Mixed model repeated measures analysis|||||0.44|-0.22|0.514
70991825|NCT01332019|141491749|SUPERIORITY_OR_OTHER||lesion mean ratio|0.49|||<|0.0001|TWO_SIDED|95.0|0.39|0.62||Lesion mean ratio (95% CI) and p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on negative binomial regression, adjusted for 302 baseline number of T2 lesions.|negative binomial regression|||Week 96||0.62|0.39|<0.0001
70991826|NCT01332019|141491750|SUPERIORITY_OR_OTHER||lesion mean ratio|0.54|||<|0.0001|TWO_SIDED|95.0|0.43|0.68||Lesion mean ratio (95% CI) and p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on negative binomial regression, adjusted for 105MS302 baseline number of Gd lesions.|negative binomial regression|||Week 48||0.68|0.43|<0.0001
70991827|NCT01332019|141491750|SUPERIORITY_OR_OTHER||lesion mean ratio|0.55|||<|0.0001|TWO_SIDED|95.0|0.43|0.71||Lesion mean ratio (95% CI) and p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on negative binomial regression, adjusted for 105MS302 baseline number of Gd lesions.|negative binomial regression|||Week 96||0.71|0.43|<0.0001
70923188|NCT05623345|141337641|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.061||0.01|TWO_SIDED|95.0|-0.28|-0.04|||Mixed model repeated measures analysis|||||-0.04|-0.28|0.010
71039327|NCT01513239|141586693|SUPERIORITY_OR_OTHER||Adjusted Difference|1.6||||0.6962|TWO_SIDED|95.0|-4.6|8.0||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus MK-6072 + SOC|||8.0|-4.6|0.6962
71039328|NCT01513239|141586694|SUPERIORITY_OR_OTHER||Difference in Percentages|-2.9||||0.408|TWO_SIDED|95.0|-9.8|4.0|||Miettinen and Nurminen||MK-3415A + SOC minus Placebo +SOC|||4.0|-9.8|0.408
71039329|NCT01513239|141586694|SUPERIORITY_OR_OTHER||Difference in Percentages|-2.3||||0.517|TWO_SIDED|95.0|-9.2|4.6|||Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||4.6|-9.2|0.517
71039330|NCT01513239|141586695|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.2||||0.931|TWO_SIDED|95.0|-3.8|3.5|||Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC|||3.5|-3.8|0.931
71039331|NCT01513239|141586695|SUPERIORITY_OR_OTHER||Difference in Percentages|0.0||||0.997|TWO_SIDED|95.0|-3.7|3.6|||Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||3.6|-3.7|0.997
71039332|NCT01513239|141586696|SUPERIORITY_OR_OTHER||Difference in Percentages|0.5||||0.328|TWO_SIDED|95.0|-0.8|2.0|||Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC|||2.0|-0.8|0.328
70923189|NCT05623345|141337641|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.061||0.006|TWO_SIDED|95.0|-0.29|-0.05|||Mixed model repeated measures analysis|||||-0.05|-0.29|0.006
70923190|NCT05384730|141337654|SUPERIORITY|||||||0.1|||||||ANOVA|||Light physical activity compared overtime||||0.10
70923191|NCT05384730|141337654|SUPERIORITY|||||||0.3|||||||ANOVA|||Moderate-vigorous physical activity compared overtime||||0.30
70923192|NCT05384730|141337654|SUPERIORITY|||||||0.18|||||||ANOVA|||Inactive/sedentary time compared overtime||||0.18
71039333|NCT01513239|141586696|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.3||||0.308|TWO_SIDED|95.0|-1.5|0.7|||Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||0.7|-1.5|0.308
71039334|NCT01513239|141586697|SUPERIORITY_OR_OTHER||Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC|||1.0|-1.0|>0.999
71039335|NCT01513239|141586697|SUPERIORITY_OR_OTHER||Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||1.0|-1.0|>0.999
71039336|NCT01513239|141586698|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.4|||||TWO_SIDED|95.0|-4.2|3.3|||||MK-3415A + SOC minus Placebo + SOC|||3.3|-4.2|
71039337|NCT01513239|141586698|SUPERIORITY_OR_OTHER||Difference in Percentages|1.2|||||TWO_SIDED|95.0|-2.7|5.2|||||MK-6072 + SOC minus Placebo + SOC|||5.2|-2.7|
71039338|NCT00059332|141586721|SUPERIORITY_OR_OTHER|||||||0.28|ONE_SIDED||||||Cochran-Mantel-Haenszel|||For the primary efficacy analysis, data were analyzed to test the null hypothesis that the distribution of scores over all 7 levels of the modified Rankin Scale at Day 90 was identical in the magnesium sulfate and placebo groups, vs. the one-sided alternative that the distribution of scores is shifted lower in the active magnesium sulfate therapy group. The statistic used to test the primary hypothesis was the Cochran-Mantel-Haenszel test statistic stratified by transport vehicle.||||0.28
71039339|NCT00059332|141586722|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.87|TWO_SIDED|95.0|0.81|1.2|||Chi-squared|||||1.20|0.81|0.87
71039340|NCT00059332|141586723|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.87|TWO_SIDED|95.0|0.81|1.19|||Chi-squared|||||1.19|0.81|0.87
71039341|NCT00059332|141586724|SUPERIORITY_OR_OTHER|||||||0.276|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.2760
71039342|NCT00059332|141586725|SUPERIORITY_OR_OTHER|||||||0.3912|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.3912
70991828|NCT01332019|141491751|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on multiple logit regression, adjusted for 302 baseline number of T1 lesions.|Regression, Logistic|||Week 48||||<0.0001
70991829|NCT01332019|141491751|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on multiple logit regression, adjusted for 302 baseline number of T1 lesions.|Regression, Logistic|||Week 96||||<0.0001
70991830|NCT01332019|141491752|SUPERIORITY_OR_OTHER|||||||0.0012||||||p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on multiple logit regression, adjusted for 302 baseline number of Gd-enhancing lesion.|Regression, Logistic|||Week 48||||0.0012
70923193|NCT05384730|141337655|SUPERIORITY|||||||0.14|||||||Chi-squared|||||||0.14
70923194|NCT05384730|141337656|SUPERIORITY|||||||0.01|||||||ANOVA|||||||0.01
70923195|NCT05384730|141337657|SUPERIORITY|||||||0.5|||||||ANOVA|||||||0.50
70923196|NCT05384730|141337658|SUPERIORITY|||||||0.03|||||||Chi-squared|||Comparing depression scores overtime||||0.03
70923197|NCT05384730|141337658|SUPERIORITY|||||||0.96|||||||Chi-squared|||Comparing anxiety scores overtime||||0.96
70923198|NCT05384730|141337659|SUPERIORITY|||||||0.04|||||||Chi-squared|||||||0.04
70923199|NCT05384730|141337660|SUPERIORITY|||||||0.13|||||||ANOVA|||||||0.13
70923200|NCT05384730|141337661|SUPERIORITY|||||||0.01|||||||ANOVA|||PASE analysis over time||||0.01
70923201|NCT01772472|141337662|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001||95.0|0.44|0.66|||Log Rank|||||0.66|0.44|<0.0001
70923202|NCT01772472|141337663|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001||95.0|0.44|0.66|||Log Rank|||||0.66|0.44|<0.0001
70923203|NCT01772472|141337664|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.44|0.66|||Log Rank|||||0.66|0.44|<.0001
70923204|NCT01772472|141337665|SUPERIORITY||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.46|0.69|||Log Rank|||||0.69|0.46|<.0001
70923205|NCT01772472|141337666|SUPERIORITY||Hazard Ratio (HR)|0.57|||<|0.0001||95.0|0.46|0.69|||Log Rank|||||0.69|0.46|<0.0001
70923206|NCT01772472|141337667|SUPERIORITY||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.46|0.69|||Log Rank|||||0.69|0.46|<.0001
70923207|NCT01772472|141337668|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001||95.0|0.48|0.7|||Log Rank|||||0.70|0.48|<0.0001
70923208|NCT01772472|141337669|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001||95.0|0.48|0.7|||Log Rank|||||0.70|0.48|<0.0001
70923209|NCT01772472|141337670|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.48|0.7|||Log Rank|||||0.70|0.48|<.0001
70923210|NCT01772472|141337671|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0082|TWO_SIDED|95.0|0.53|0.91|||Log Rank|||||0.91|0.53|0.0082
70923211|NCT01772472|141337672|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0082||95.0|0.53|0.91|||Log Rank|||||0.91|0.53|0.0082
70923212|NCT01772472|141337673|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0082|TWO_SIDED|95.0|0.53|0.91|||Log Rank|||||0.91|0.53|0.0082
70923213|NCT01772472|141337674|SUPERIORITY||Hazard Ratio (HR)|0.6|||<|0.0001||95.0|0.47|0.76|||Log Rank|||||0.76|0.47|<0.0001
70923214|NCT01772472|141337675|SUPERIORITY||Hazard Ratio (HR)|0.6|||<|0.0001||95.0|0.47|0.76|||Log Rank|||||0.76|0.47|<0.0001
70923215|NCT01772472|141337676|SUPERIORITY||Hazard Ratio (HR)|0.6|||<|0.0001|TWO_SIDED|95.0|0.47|0.76|||Log Rank|||||0.76|0.47|<.0001
70923216|NCT04093752|141337729|NON_INFERIORITY|The study was powered for superiority in HbA1c. The sample size provided \>99% power to show noninferiority assuming a 0.4% noninferiority (NI) boundary, 0.45% greater mean reduction in tirzepatide doses compared to insulin glargine, 1:1:1:1 randomization, a common standard deviation (SD) of 1.2%, one-sided significance level of 0.0125 and a dropout rate of 25%.|LS Mean Difference|-1.49|||||TWO_SIDED|95.0|-1.69|-1.29||||||||-1.29|-1.69|
70991831|NCT01332019|141491752|SUPERIORITY_OR_OTHER|||||||0.0026||||||p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on multiple logit regression, adjusted for 302 baseline number of Gd-enhancing lesion.|Regression, Logistic|||Week 96||||0.0026
70991832|NCT01332019|141491758|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.57||||0.006|TWO_SIDED|95.0|0.38|0.85||Based on Cox Proportional Hazards model, adjusted for 105MS302 baseline EDSS and age (\<40 vs \>=40).|Cox Proportional Hazards model||q2w/q4w|||0.85|0.38|0.0060
70991833|NCT00980785|141491781|OTHER|Mann-Whitney test|Mean Difference (Final Values)|-22.5|STANDARD_DEVIATION|78.7||0.836|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.836
70991834|NCT00980785|141491781|OTHER|Mann-Whitney Test|Mean Difference (Final Values)|-31.71|STANDARD_DEVIATION|90.6||0.836|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.836
70991835|NCT00980785|141491782|OTHER|Mann-Whitney Test|Mean Difference (Final Values)|-0.1|STANDARD_DEVIATION|0.21||0.009|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.009
70991836|NCT00980785|141491782|OTHER|Mann-Whitney Test|Mean Difference (Final Values)|-0.63|STANDARD_DEVIATION|0.32||0.009|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.009
70991837|NCT00980785|141491783|OTHER|Mann-Whitney Test|Mean Difference (Final Values)|-0.7|STANDARD_DEVIATION|1.56||0.755|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.755
70991838|NCT00980785|141491783|OTHER|Mann-Whitney test|Mean Difference (Final Values)|-0.29|STANDARD_DEVIATION|1.23||0.755|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.755
70991839|NCT00980785|141491784|OTHER|Mann-Whitney test|Mean Difference (Final Values)|1.7|STANDARD_DEVIATION|8.9||0.491|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.491
70991840|NCT00980785|141491784|OTHER|Mann-Whitney test|Mean Difference (Final Values)|-1.8|STANDARD_DEVIATION|2.2||0.491|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.491
70991841|NCT00922194|141491795|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-8.36|STANDARD_DEVIATION|3.3|<|0.05||95.0|-9.03|-7.72|||Paired t test|||Analysis of difference between 12 months or more and baseline values||-7.72|-9.03|<0.05
70991842|NCT00922194|141491796|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.27|||<|0.05||95.0|-3.5|-3.0|||Wilcoxon paired signed rank-sum test|||Analysis of difference between 12 months or more and baseline values||-3.0|-3.5|<0.05
70991843|NCT00922194|141491797|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-7.41|||<|0.05||95.0|-8.37|-6.47|||Wilcoxon paired signed rank-sum test|||Analysis of difference between 12 months and baseline values||-6.47|-8.37|<0.05
70923217|NCT04093752|141337729|NON_INFERIORITY|The study was powered for superiority in HbA1c. The sample size provided \>99% power to show noninferiority assuming a 0.4% NI boundary, 0.45% greater mean reduction in tirzepatide doses compared to insulin glargine, 1:1:1:1 randomization, a common SD of 1.2%, one-sided significance level of 0.0125 and a dropout rate of 25%.|LS Mean Difference|-1.54|||||TWO_SIDED|95.0|-1.74|-1.34||||||||-1.34|-1.74|
70923218|NCT04093752|141337730|NON_INFERIORITY|The study was powered for superiority in HbA1c. The sample size provided \>99% power to show noninferiority assuming a 0.4% NI boundary, 0.45% greater mean reduction in tirzepatide doses compared to insulin glargine, 1:1:1:1 randomization, a common SD of 1.2%, one-sided significance level of 0.0125 and a dropout rate of 25%.|LS Mean Difference|-1.29|||||TWO_SIDED|95.0|-1.49|-1.09||||||||-1.09|-1.49|
70923219|NCT04093752|141337731|SUPERIORITY||LS Mean Difference|-6.5|||<|0.001|TWO_SIDED|95.0|-7.4|-5.6|||Mixed Models Analysis|||||-5.6|-7.4|<0.001
70923220|NCT04093752|141337731|SUPERIORITY||LS Mean Difference|-8.5|||<|0.001|TWO_SIDED|95.0|-9.5|-7.6|||Mixed Models Analysis|||||-7.6|-9.5|<0.001
70923221|NCT04093752|141337731|SUPERIORITY||LS Mean Difference|-8.7|||<|0.001|TWO_SIDED|95.0|-9.6|-7.7|||Mixed Models Analysis|||||-7.7|-9.6|<0.001
70923222|NCT04093752|141337732|SUPERIORITY||Odds Ratio (OR)|14.54|||<|0.001|TWO_SIDED|95.0|8.94|23.64|||Regression, Logistic|||||23.64|8.94|<0.001
70923223|NCT04093752|141337732|SUPERIORITY||Odds Ratio (OR)|28.76|||<|0.001|TWO_SIDED|95.0|16.72|49.49|||Regression, Logistic|||||49.49|16.72|<0.001
70923224|NCT04093752|141337732|SUPERIORITY||Odds Ratio (OR)|25.27|||<|0.001|TWO_SIDED|95.0|14.88|42.95|||Regression, Logistic|||||42.95|14.88|<0.001
70991844|NCT00922194|141491798|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.014|||<|0.05||95.0|-0.02|0.001|||Wilcoxon paired sign rank-sum test|||Analysis of difference between 12 months or more and baseline values||0.001|-0.02|<0.05
70991845|NCT00922194|141491799|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.61|||<|0.05||95.0|-5.2|-3.8|||Wilcoxon paired signed rank-sum test|||Analysis of difference between 12 months and baseline values||-3.8|-5.2|<0.05
70991846|NCT00922194|141491800|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.97|||<|0.05||95.0|-3.57|-2.38|||Wilcoxon paired signed rank-sum test|||Analysis of difference between 12 months and baseline values||-2.38|-3.57|<0.05
70991847|NCT00922194|141491801|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.37|||<|0.05||95.0|-2.65|-2.08|||Wilcoxon paired signed rank-sum test|||Analysis of difference between 12 months and baseline values||-2.08|-2.65|<0.05
70991848|NCT03072719|141491806|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-0.19||||0.1774|TWO_SIDED|95.0|-0.46|0.09||From ANCOVA model: Treatment as fixed factor, baseline Schiff Sensitivity score as covariate.|ANCOVA||Difference is 0.454% stannous fluoride minus 0.76% sodium monofluorophosphate such that a negative difference favours first named treatment.|"H0 : The difference in Schiff Sensitivity Score at Day 14 between the experimental dentifrice and reference dentifrice is zero.~H1 : The difference in Schiff Sensitivity Score at Day 14 between the experimental dentifrice and reference dentifrice is not zero."||0.09|-0.46|0.1774
70991849|NCT01757405|141491869|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence of treatment success proportions in all bleeding episodes for the two treatment groups was determined by comparing the 90% two-sided CI of the ratio of success proportions to the equivalence region defined as \[0.83, 1.20\].|Ratio of success proportion|1.21|||||TWO_SIDED|90.0|1.15|1.28|||Ratio of success proportion|||Equivalence test of successfully treated bleeding episodes (BEs) between or within treatment arms. Denoting the success rates in the two treatment groups by p1 and p2 , the null hypotheses of H01 : p1/p2 \< 0.83 and H02 : p1/p2 \> 1.20 was implicitly tested against the one-sided alternatives Ha1: 0.83 ≤ p1/p2 and Ha2 : p1/p2 ≤ 1.20, by comparing the 90% two-sided confidence interval (CI) of the ratio of success proportions to the equivalence region defined as \[0.83, 1.20\].||1.28|1.15|
71039343|NCT00059332|141586726|SUPERIORITY_OR_OTHER|||||||0.323|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.3230
71039344|NCT00059332|141586727|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.95|TWO_SIDED|95.0|0.87|1.27|||Chi-squared|||||1.27|0.87|0.95
70923225|NCT04093752|141337733|SUPERIORITY||Odds Ratio (OR)|82.54||||0.002|TWO_SIDED|95.0|5.13|1327.81|||Regression, Logistic|||||1327.81|5.13|0.002
70923226|NCT04093752|141337733|SUPERIORITY||Odds Ratio (OR)|124.76|||<|0.001|TWO_SIDED|95.0|7.79|1997.01|||Regression, Logistic|||||1997.01|7.79|<0.001
70923227|NCT04093752|141337733|SUPERIORITY||Odds Ratio (OR)|184.9|||<|0.001|TWO_SIDED|95.0|11.59|2950.73|||Regression, Logistic|||||2950.73|11.59|<0.001
70923228|NCT04093752|141337734|SUPERIORITY||LS Mean Difference|-12.3|||<|0.001|TWO_SIDED|95.0|-18.3|-6.3|||Mixed Models Analysis|||||-6.3|-18.3|<0.001
70923229|NCT04093752|141337734|SUPERIORITY||LS Mean Difference|-20.0|||<|0.001|TWO_SIDED|95.0|-26.1|-13.9|||Mixed Models Analysis|||||-13.9|-26.1|<0.001
70923230|NCT04093752|141337734|SUPERIORITY||LS Mean Difference|-18.6|||<|0.001|TWO_SIDED|95.0|-24.6|-12.5|||Mixed Models Analysis|||||-12.5|-24.6|<0.001
70923231|NCT04093752|141337735|SUPERIORITY||LS Mean Difference|-34.2|||<|0.001|TWO_SIDED|95.0|-40.1|-28.3|||Mixed Models Analysis|||||-28.3|-40.1|<0.001
70923232|NCT04093752|141337735|SUPERIORITY||LS Mean Difference|-40.6|||<|0.001|TWO_SIDED|95.0|-46.7|-34.6|||Mixed Models Analysis|||||-34.6|-46.7|<0.001
70923233|NCT04093752|141337735|SUPERIORITY||LS Mean Difference|-41.8|||<|0.001|TWO_SIDED|95.0|-47.9|-35.8|||Mixed Models Analysis|||||-35.8|-47.9|<0.001
71039345|NCT00059332|141586728|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62||||0.12|TWO_SIDED|95.0|0.34|1.14|||Chi-squared|||||1.14|0.34|0.12
71039346|NCT00059332|141586729|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.95|TWO_SIDED|95.0|0.76|1.29|||Chi-squared|||||1.29|0.76|0.95
70991850|NCT01358877|141491897|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0446|TWO_SIDED|95.0|0.66|1.0||Statistical significance was controlled at a two-sided alpha level of 0.05.|Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.||1.00|0.66|0.0446
70991851|NCT01358877|141491899|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.043|TWO_SIDED|95.0|0.68|0.99||Statistical significance was controlled at a two-sided alpha level of 0.05.|Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.||0.99|0.68|0.0430
70991852|NCT01358877|141491901|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0327|TWO_SIDED|95.0|0.67|0.98||Statistical significance was controlled at a two-sided alpha level of 0.05.|Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.||0.98|0.67|0.0327
70991853|NCT01358877|141491903|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.4673|TWO_SIDED|95.0|0.66|1.21||Statistical significance was controlled at a two-sided alpha level of 0.05.|Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.||1.21|0.66|0.4673
70991854|NCT01358877|141491905|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.043|TWO_SIDED|95.0|0.63|0.99|||Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.||0.99|0.63|0.0430
70991855|NCT01358877|141491907|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.1007|TWO_SIDED|95.0|0.64|1.04|||Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.||1.04|0.64|0.1007
70991856|NCT01358877|141491909|SUPERIORITY||Treatment Difference|0.4|||||TWO_SIDED|95.0|0.0|0.8|||||The difference in percentage of participants with a primary cardiac event between the pertuzumab and placebo arms. The 95% confidence interval (CI) was estimated using Hauck-Anderson correction.|||0.8|0.0|
70991857|NCT01358877|141491910|SUPERIORITY||Treatment Difference|-0.1|||||TWO_SIDED|95.0|-1.0|0.9|||||95% CI was estimated using Hauck-Anderson correction.|||0.9|-1.0|
70991858|NCT01358877|141491911|SUPERIORITY||Treatment Difference|0.1|||||TWO_SIDED|95.0|-0.3|0.5|||||95% CI was estimated using Hauck-Anderson correction.|||0.5|-0.3|
70991859|NCT03575884|141491942|SUPERIORITY||Study_arm timepoint interactions|-27.32|||<|0.05|TWO_SIDED|95.0|-52.49|-2.14|||Mixed Models Analysis|||||-2.14|-52.49|<0.05
70991860|NCT01980706|141491977|SUPERIORITY||Mean Difference (Net)|4.16||||0.018|TWO_SIDED|||||Threshold for significance is \<.05|Mixed Models Analysis||Overall, treatment effect F value testing under the null hypothesis the equality of the average outcome over the three groups.|||||0.018
70991861|NCT01980706|141491978|SUPERIORITY||Mean Difference (Net)|3.68||||0.028|TWO_SIDED|||||Threshold for significance is \<.05|Mixed Models Analysis||Overall, treatment effect F value testing under the null hypothesis the equality of the average outcome over the three groups.|||||0.028
70991862|NCT01980706|141491979|SUPERIORITY||Mean Difference (Net)|0.65||||0.52|TWO_SIDED|||||Threshold for significance is \<.05|Mixed Models Analysis||Overall, treatment effect F value testing under the null hypothesis the equality of the average outcome over the three groups.|||||0.52
70991863|NCT01980706|141491980|SUPERIORITY||Mean Difference (Net)|0.84||||0.43|TWO_SIDED|||||Threshold for significance is \<.05|Mixed Models Analysis||Overall, treatment effect F value testing under the null hypothesis the equality of the average outcome over the three groups.|||||0.43
70991864|NCT01980706|141491981|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.6|TWO_SIDED|||||Threshold for significance is \<.05|ANCOVA|Adjusted for baseline|Estimated parameter is the overall treatment main effect F statistic from the fitted ANCOVA model assessing the null hypothesis of equal values across the three groups|||||0.60
70991865|NCT01980706|141491982|SUPERIORITY||Table probability for Fisher's Exact|0.002||||0.07|TWO_SIDED|||||Threshold for significance is \<.05|Fisher Exact|||||||0.07
70991866|NCT02403830|141491983|SUPERIORITY||Mean Difference (Final Values)|-32.0||||0.261|TWO_SIDED|95.0|-90.0|25.0|||Mixed Models Analysis|||||25|-90|0.261
70991867|NCT00677690|141491998|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||"All data were expressed as the mean ± SD. The level of significance for all tests was set at p \< 0.05.~Inter- and intra-group comparisons were performed using both paired and unpaired t tests for continuous variables and Chi squared for categorical variables."||||< 0.05
70991868|NCT00677690|141491999|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||||||<0.05
70991869|NCT00677690|141492000|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||||||<0.05
70991870|NCT00677690|141492001|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||||||<0.05
70991871|NCT00677690|141492002|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||||||<0.05
70991872|NCT01106625|141492003|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.097|<|0.001|TWO_SIDED|95.0|-0.904|-0.524|||ANCOVA|||||-0.524|-0.904|<0.001
70991873|NCT01106625|141492003|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.097|<|0.001|TWO_SIDED|95.0|-1.114|-0.732|||ANCOVA|||||-0.732|-1.114|<0.001
70991874|NCT01106625|141492004|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.42|||<|0.001|TWO_SIDED|95.0|2.48|7.87|||Regression, Logistic|||||7.87|2.48|<0.001
70991875|NCT01106625|141492004|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.8|||<|0.001|TWO_SIDED|95.0|4.86|15.95|||Regression, Logistic|||||15.95|4.86|<0.001
70991876|NCT01106625|141492005|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-22.3|STANDARD_ERROR_OF_MEAN|4.627|<|0.001|TWO_SIDED|95.0|-31.53|-13.16|||ANCOVA|||||-13.16|-31.53|<0.001
70991877|NCT01106625|141492005|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-34.6|STANDARD_ERROR_OF_MEAN|4.692|<|0.001|TWO_SIDED|95.0|-43.86|-25.42|||ANCOVA|||||-25.42|-43.86|<0.001
70991878|NCT01106625|141492006|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.1|-0.7|||ANCOVA|||||-0.7|-2.1|<0.001
70991879|NCT01106625|141492006|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.7|-1.3|||ANCOVA|||||-1.3|-2.7|<0.001
70991880|NCT01106625|141492007|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.24|STANDARD_ERROR_OF_MEAN|1.262||0.077|TWO_SIDED|95.0|-4.719|0.241|||ANCOVA|||||0.241|-4.719|0.077
70991881|NCT01106625|141492007|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.62|STANDARD_ERROR_OF_MEAN|1.266||0.201|TWO_SIDED|95.0|-4.111|0.866|||ANCOVA|||||0.866|-4.111|0.201
70991882|NCT01106625|141492008|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-6.2|STANDARD_ERROR_OF_MEAN|5.4||0.256|TWO_SIDED|95.0|-16.9|4.5|||ANCOVA|||||4.5|-16.9|0.256
70991883|NCT01106625|141492008|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|5.5||0.571|TWO_SIDED|95.0|-13.8|7.6|||ANCOVA|||||7.6|-13.8|0.571
70991884|NCT01106625|141492009|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|1.7||0.153|TWO_SIDED|95.0|-0.9|5.9|||ANCOVA|||||5.9|-0.9|0.153
70991885|NCT01106625|141492009|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|1.8||0.056|TWO_SIDED|95.0|-0.1|6.8|||ANCOVA|||||6.8|-0.1|0.056
70991886|NCT01088438|141492015|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|1 degree of freedom||Null hypothesis: proportion of encounters with contextual red flag in which appropriate treatment is planned is the same in the two groups.||||<0.001
70991887|NCT01088438|141492016|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|1 degree of freedom||Null hypothesis is equal proportion of contextual red flags probed in control and intervention groups.||||<.001
70991888|NCT01088438|141492017|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Chi-squared|1 df||Null hypothesis is equal proportion of encounters probed in control and intervention groups.||||0.85
70991889|NCT00511342|141492020|SUPERIORITY_OR_OTHER_LEGACY||Difference of adjusted means|-0.078||||0.19|TWO_SIDED|95.0|-0.198|0.041||No corrections for multiple comparisons were made for these safety parameters. The a-priori threshold for statistical significance was 0.05.|ANCOVA|The ANCOVA included the Z-score values at baseline as adjusted factor.|NOMAC-E2 minus LNG-EE for lumbar spine (L2-L4)|||0.041|-0.198|0.19
70991890|NCT00511342|141492020|SUPERIORITY_OR_OTHER_LEGACY||Difference of adjusted means|-0.03||||0.57|TWO_SIDED|95.0|-0.136|0.075||No corrections for multiple comparisons were made for these safety parameters. The a-priori threshold for statistical significance was 0.05.|ANCOVA|The ANCOVA included the Z-score values at baseline as adjusted factor.|NOMAC-E2 minus LNG-EE for femoral neck|||0.075|-0.136|0.57
70991891|NCT02458690|141492034|SUPERIORITY|||||||0.6|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||0.60
70991892|NCT02458690|141492035|SUPERIORITY||||||<|0.01|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||<0.01
70991893|NCT02458690|141492036|SUPERIORITY|||||||0.81|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||0.81
70991894|NCT02458690|141492037|SUPERIORITY|||||||0.2|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||0.20
70991895|NCT02458690|141492038|SUPERIORITY|||||||0.09|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||0.09
70991896|NCT02458690|141492039|SUPERIORITY|||||||0.23|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||0.23
70991897|NCT02458690|141492040|SUPERIORITY|||||||0.09|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||0.09
70991898|NCT03615469|141492041|OTHER|t-test||||||0.22|||||||t-test, 2 sided|||||||0.22
70991899|NCT01153763|141492042|OTHER||percentage of participants|59.0|||||TWO_SIDED|95.0|48.2|70.3|||||The estimated value represents the percentage of participants with a confirmed CR or a confirmed PR.|||70.3|48.2|
70991900|NCT01153763|141492043|OTHER||percentage of participants|13.0|||||TWO_SIDED|95.0|0.0|28.7|||||The estimated value represents the percentage of participants with a investigator assessed CR or PR.|||28.7|0.0|
70991901|NCT01153763|141492048|OTHER||percentage of participants|20.0|||||TWO_SIDED|95.0|11.6|29.8|||||The estimated value represents the percentage of participants with overall survival.|||29.8|11.6|
70991902|NCT01153763|141492049|OTHER||percentage of participants|13.0|||||TWO_SIDED|95.0|2.2|34.6|||||The estimated value represents the percentage of participants with overall survival.|||34.6|2.2|
70991903|NCT02402218|141492055|SUPERIORITY|||||||0.11||||||For the primary and secondary outcomes, the proportion of participants with the outcome in each group was compared using a chi-square test.|Chi-squared|||Sample size was based on an estimated HCV treatment initiation rate of 50% in the UC group (based on a 33% rate observed during the interferon era) and 80% in the intervention groups, a significance level of 0.05, a desired ratio of participants in the intervention group compared to UC group of 3 to 2, and power of 80% to detect this difference between groups. The study was not powered to detect differences between the peer and cash groups.||||.11
70991904|NCT02402218|141492056|SUPERIORITY|||||||0.22|||||||Chi-squared|||||||.22
70991905|NCT02402218|141492058|SUPERIORITY|||||||0.33|||||||Chi-squared|||changes in the frequency of drug and alcohol use before and during treatment were compared using chi-square tests to evaluate the safety of cash incentives.||||0.33
70991906|NCT02402218|141492059|SUPERIORITY|||||||0.3||||||changes in the frequency of drug and alcohol use before and during treatment were compared using chi-square tests to evaluate the safety of cash incentives.|Chi-squared|||||||0.30
70991907|NCT03534063|141492085|SUPERIORITY|||||||0.047|||||||Wilcoxon (Mann-Whitney)|Comparisons for opioid consumption and composite pain intensity were performed by analysis of covariance, adjusting for baseline differences in groups||||||.047
70991908|NCT03534063|141492086|SUPERIORITY|||||||0.638|||||||t-test, 2 sided|||||||.638
71098862|NCT00324857|141706418|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||"Please note that although the outcome is measured using a Likert scale, for the analysis we dichotomized the results.~P-value not adjusted for multiple comparison. Lastly, \<0.05 is the actual computed P-value."|Regression, Logistic|||Comparisons of the baseline demographic and clinical characteristics (TKR) across the 4 intervention groups were performed using chi-square tests for categorical data and analysis of variance for continuous variables. Willingness were compared across the groups over time using mixed-effect logistic regressions for dichotomous outcomes.||||<0.05
70991909|NCT00789191|141492119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.001||95.0|-0.77|-0.33||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|ANCOVA|Analysis of covariance (ANCOVA) was used; baseline HbA1c was included as covariate and treatment, stratification and country was included as factors||Null hypothesis: Difference between mean HbA1c in the two treatment arms is equal to zero. Power calculation: Assuming a standard deviation of 1.0 for HbA1c, 100 subjects in each treatment arm would be required to obtain a power of 80% for detecting a HbA1c difference of 0.4%||-0.33|-0.77|0.0010
71098863|NCT01557244|141706420|SUPERIORITY|||||||0.0001|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an analysis of covariance (ANCOVA) model with terms for treatment group, baseline maximum cystometric bladder capacity and baseline weight.||||0.0001
71098864|NCT01557244|141706420|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on ANCOVA model with terms for treatment group, baseline maximum cystometric bladder capacity and baseline weight.||||<.0001
71098865|NCT01557244|141706420|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline maximum cystometric bladder capacity and baseline weight.||||<.0001
71098866|NCT01557244|141706420|OTHER||Difference in Least square (LS) Mean|-29.06|||||TWO_SIDED|95.0|-71.42|13.31||||||||13.31|-71.42|
71098867|NCT01557244|141706420|OTHER||Difference in LS Mean|-3.82|||||TWO_SIDED|95.0|-45.87|38.23||||||||38.23|-45.87|
70923234|NCT04093752|141337736|SUPERIORITY||Odds Ratio (OR)|21.89|||<|0.001|TWO_SIDED|95.0|11.63|41.2|||Regression, Logistic|||||41.20|11.63|<0.001
70991910|NCT00789191|141492120|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.2||||0.001||95.0|1.65|6.19||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|Regression, Logistic|Treatment group comparison using logistic regression model incl.treatment,stratification factor, country as fixed effects, baseline HbA1c as covariate||Null hypothesis: Odds ratio is equal to one.||6.19|1.65|0.0010
71098868|NCT01557244|141706421|SUPERIORITY|||||||0.2334|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline detrusor pressure at maximum bladder capacity and baseline weight.||||0.2334
71098869|NCT01557244|141706421|SUPERIORITY|||||||0.5087|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline detrusor pressure at maximum bladder capacity and baseline weight.||||0.5087
71098870|NCT01557244|141706421|SUPERIORITY|||||||0.3333|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline detrusor pressure at maximum bladder capacity and baseline weight.||||0.3333
71098871|NCT01557244|141706421|OTHER||Difference in LS Mean|-0.47|||||TWO_SIDED|95.0|-7.28|6.33||||||||6.33|-7.28|
71098872|NCT01557244|141706421|OTHER||Difference in LS Mean|0.82|||||TWO_SIDED|95.0|-5.96|7.6||||||||7.60|-5.96|
71098873|NCT01557244|141706423|SUPERIORITY|||||||0.0336|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder volume at first IDC and baseline weight.||||0.0336
71098874|NCT01557244|141706423|SUPERIORITY|||||||0.0327|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder volume at first IDC and baseline weight.||||0.0327
71098875|NCT01557244|141706423|SUPERIORITY|||||||0.0017|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder volume at first IDC and baseline weight.||||0.0017
71098876|NCT01557244|141706423|OTHER||Difference in LS Mean|-10.78|||||TWO_SIDED|95.0|-48.75|27.19||||||||27.19|-48.75|
71098877|NCT01557244|141706423|OTHER||Difference in LS Mean|-15.25|||||TWO_SIDED|95.0|-50.15|19.64||||||||19.64|-50.15|
71098878|NCT01557244|141706424|SUPERIORITY|||||||0.0679|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder compliance and baseline weight.||||0.0679
70991911|NCT00789191|141492121|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.47||||0.008||95.0|1.26|4.81||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|Regression, Logistic|Treatment group comparison using logistic regression model incl.treatment,stratification factor, country as fixed effects, baseline HbA1c as covariate||Null hypothesis: Odds ratio is equal to one.||4.81|1.26|0.0080
70991912|NCT00789191|141492122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.23||||0.063||95.0|0.96|5.2||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|Regression, Logistic|Treatment group comparison using logistic regression model incl.treatment,stratification factor, country as fixed effects, baseline HbA1c as covariate||Null hypothesis: Odds ratio is equal to one.||5.20|0.96|0.063
70991913|NCT00789191|141492123|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.07||||0.135||95.0|0.8|5.37||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|Regression, Logistic||Treatment group comparison using logistic regression model incl.treatment,stratification factor, country as fixed effects, baseline HbA1c as covariate|Null hypothesis: Odds ratio is equal to one.||5.37|0.8|0.135
71098879|NCT01557244|141706424|SUPERIORITY|||||||0.1233|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder compliance and baseline weight.||||0.1233
71098880|NCT01557244|141706424|SUPERIORITY|||||||0.0019|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder compliance and baseline weight.||||0.0019
71098881|NCT01557244|141706424|OTHER||Difference in LS Mean|-4.96|||||TWO_SIDED|95.0|-14.81|4.89||||||||4.89|-14.81|
71098882|NCT01557244|141706424|OTHER||Difference in LS Mean|-5.95|||||TWO_SIDED|95.0|-15.85|3.95||||||||3.95|-15.85|
71098883|NCT01557244|141706425|SUPERIORITY|||||||0.0116|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions per 24 hours and baseline weight.||||0.0116
71098884|NCT01557244|141706425|SUPERIORITY|||||||0.0765|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions per 24 hours and baseline weight.||||0.0765
71098885|NCT01557244|141706425|SUPERIORITY|||||||0.0061|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions per 24 hours and baseline weight.||||0.0061
71098886|NCT01557244|141706425|OTHER||Difference in LS Mean|-0.1|||||TWO_SIDED|95.0|-1.16|0.97||||||||0.97|-1.16|
71098887|NCT01557244|141706425|OTHER||Difference in LS Mean|0.28|||||TWO_SIDED|95.0|-0.74|1.31||||||||1.31|-0.74|
71098888|NCT01557244|141706426|SUPERIORITY|||||||0.0787|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of catheterizations per 24 hours and baseline weight.||||0.0787
71098889|NCT01557244|141706426|SUPERIORITY|||||||0.0727|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of catheterizations per 24 hours and baseline weight.||||0.0727
71098890|NCT01557244|141706426|SUPERIORITY|||||||0.0666|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of catheterizations per 24 hours and baseline weight.||||0.0666
71098891|NCT01557244|141706426|OTHER||Difference in LS Mean|0.04|||||TWO_SIDED|95.0|-0.45|0.54||||||||0.54|-0.45|
71098892|NCT01557244|141706426|OTHER||Difference in LS Mean|0.02|||||TWO_SIDED|95.0|-0.49|0.52||||||||0.52|-0.49|
71098893|NCT01557244|141706427|SUPERIORITY|||||||0.0111|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions and catheterizations combined per 24 hours and baseline weight.||||0.0111
71098894|NCT01557244|141706427|SUPERIORITY|||||||0.0171|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions and catheterizations combined per 24 hours and baseline weight.||||0.0171
71098895|NCT01557244|141706427|SUPERIORITY|||||||0.0028|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions and catheterizations combined per 24 hours and baseline weight.||||0.0028
71098896|NCT01557244|141706427|OTHER||Difference in LS Mean|0.14|||||TWO_SIDED|95.0|-0.53|0.82||||||||0.82|-0.53|
71098897|NCT01557244|141706427|OTHER||Difference in LS Mean|0.15|||||TWO_SIDED|95.0|-0.54|0.84||||||||0.84|-0.54|
71098898|NCT01557244|141706428|SUPERIORITY|||||||0.0496|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of incontinence episodes per 24 hours and baseline weight.||||0.0496
70991914|NCT00789191|141492124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.121||95.0|-0.07|0.63||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|ANCOVA|An analysis of covariance (ANCOVA) was used; baseline was included as covariate and treatment, stratification and country was included as factors.||||0.63|-0.07|0.121
70991915|NCT00789191|141492125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.84||||0.109||95.0|-0.19|1.88||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|ANCOVA|An analysis of covariance (ANCOVA) was used; baseline was included as covariate and treatment, stratification and country was included as factors.||||1.88|-0.19|0.109
70991916|NCT00789191|141492126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.45||||0.001||95.0|-3.01|-1.88||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|ANCOVA|An analysis of covariance (ANCOVA) was used; baseline was included as covariate and treatment, stratification and country was included as factors.||||-1.88|-3.01|0.0010
70991917|NCT00789191|141492130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.01||||||95.0|-2.5|-1.51|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. Before breakfast|||-1.51|-2.50|
70991918|NCT00789191|141492130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.64||||||95.0|-2.4|-0.89|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. 120 minutes after start of breakfast|||-0.89|-2.40|
70991919|NCT00789191|141492130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02||||||95.0|-1.69|-0.35|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. Before lunch|||-0.35|-1.69|
70991920|NCT00789191|141492130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||||95.0|-2.05|-0.56|||Linear mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. 120 minutes after start of lunch|||-0.56|-2.05|
71098899|NCT01557244|141706428|SUPERIORITY|||||||0.0002|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of incontinence episodes per 24 hours and baseline weight.||||0.0002
70991921|NCT00789191|141492130|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.77||||||95.0|-1.58|0.05|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. Before dinner|||0.05|-1.58|
70991922|NCT00789191|141492130|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.88||||||95.0|-1.75|-0.02|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. 120 minutes after start of dinner|||-0.02|-1.75|
70991923|NCT00789191|141492130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04||||||95.0|-1.88|-0.2|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. Bedtime|||-0.20|-1.88|
70991924|NCT00789191|141492130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17||||||95.0|-1.84|-0.49|||Linear Mixed Model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. At 03:00 a.m.|||-0.49|-1.84|
70991925|NCT00789191|141492130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||||95.0|-2.26|-1.34|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. Before breakfast the following day|||-1.34|-2.26|
70991926|NCT00762372|141492158|NON_INFERIORITY|Time to extubation = treatment group + surgical site +surgery time|Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-6.6|-2.7||||||||-2.7|-6.6|
70991927|NCT00762372|141492159|NON_INFERIORITY|"Adjusted means of time from the end of study drug inhalation to extubation in the BLM-240 N2O group and sevoflurane group, which were obtained by analysis of covariance with surgical site and surgery time as covariates, were used to verify the non-inferiority of BLM-240 to the comparator sevoflurane, with a delta = 1.0 (minute) and significance level alpha = 2.5% (one-sided)."||||||0.15|||||||t-test, 2 sided|||||||0.1500
70991928|NCT00762372|141492160|NON_INFERIORITY|Two-sample t-test||||||0.0001|||||||t-test, 2 sided|||||||0.0001
70991929|NCT00762372|141492164|NON_INFERIORITY|Fisher's exact test||||||0.3113|||||||Fisher Exact|||||||0.3113
70991930|NCT00762372|141492166|NON_INFERIORITY|Fisher's exact test||||||1|||||||Fisher Exact|||||||1.0000
70991931|NCT03364335|141492170|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.5461|||||||ANCOVA|||||||0.5461
70991932|NCT03364335|141492170|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0364|||||||ANCOVA|||||||0.0364
70991933|NCT03364335|141492170|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0156|||||||ANCOVA|||||||0.0156
70991934|NCT03364335|141492170|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0349|||||||ANCOVA|||||||0.0349
70991935|NCT03364335|141492171|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.5348|||||||ANCOVA|||||||0.5348
70991936|NCT03364335|141492171|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0379|||||||ANCOVA|||||||0.0379
71098900|NCT01557244|141706428|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of incontinence episodes per 24 hours and baseline weight.||||<.0001
71098901|NCT01557244|141706428|OTHER||Difference in LS Mean|0.55|||||TWO_SIDED|95.0|-0.09|1.19||||||||1.19|-0.09|
70991937|NCT03364335|141492171|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0215|||||||ANCOVA|||||||0.0215
70991938|NCT03364335|141492171|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0464|||||||ANCOVA|||||||0.0464
70991939|NCT03364335|141492172|OTHER|Pearson's Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group.||||||1|||||||Chi-squared|||||||1.0000
70991940|NCT03364335|141492172|OTHER|Pearson's Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group.||||||0.2646|||||||Chi-squared|||||||0.2646
70991941|NCT03364335|141492172|OTHER|Pearson's Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group.||||||0.0749|||||||Chi-squared|||||||0.0749
70991942|NCT03364335|141492172|OTHER|Pearson's Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group.||||||0.6758|||||||Chi-squared|||||||0.6758
70991943|NCT03364335|141492173|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.||||||0.9656|||||||ANCOVA|||||||0.9656
70991944|NCT03364335|141492173|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.||||||0.4254|||||||ANCOVA|||||||0.4254
70923235|NCT04093752|141337736|SUPERIORITY||Odds Ratio (OR)|43.79|||<|0.001|TWO_SIDED|95.0|22.96|83.5|||Regression, Logistic|||||83.50|22.96|<0.001
70991945|NCT03364335|141492173|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.||||||0.1276|||||||ANCOVA|||||||0.1276
70991946|NCT03364335|141492173|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.||||||0.5937|||||||ANCOVA|||||||0.5937
70991947|NCT03364335|141492174|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.601|||||||ANCOVA|||||||0.6010
70991948|NCT03364335|141492174|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.6513|||||||ANCOVA|||||||0.6513
70991949|NCT03364335|141492174|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.4354|||||||ANCOVA|||||||0.4354
70991950|NCT03364335|141492174|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.031|||||||ANCOVA|||||||0.0310
70991951|NCT03364335|141492175|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.4644|||||||ANCOVA|||||||0.4644
70991952|NCT03364335|141492175|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.8573|||||||ANCOVA|||||||0.8573
70991953|NCT03364335|141492175|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.8167|||||||ANCOVA|||||||0.8167
70991954|NCT03364335|141492175|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.9223|||||||ANCOVA|||||||0.9223
70991955|NCT03364335|141492176|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.6574|||||||ANCOVA|||||||0.6574
70991956|NCT03364335|141492176|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.8971|||||||ANCOVA|||||||0.8971
70991957|NCT03364335|141492176|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.6317|||||||ANCOVA|||||||0.6317
70991958|NCT03364335|141492176|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.0341|||||||ANCOVA|||||||0.0341
70991959|NCT03364335|141492177|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.372|||||||ANCOVA|||||||0.3720
70991960|NCT03364335|141492177|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.2302|||||||ANCOVA|||||||0.2302
70991961|NCT03364335|141492177|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.1377|||||||ANCOVA|||||||0.1377
70991962|NCT03364335|141492177|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.4295|||||||ANCOVA|||||||0.4295
70991963|NCT03364335|141492178|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.||||||0.6726|||||||ANCOVA|||||||0.6726
70991964|NCT03364335|141492178|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.||||||0.7934|||||||ANCOVA|||||||0.7934
71098902|NCT01557244|141706428|OTHER||Difference in LS Mean|0.12|||||TWO_SIDED|95.0|-0.52|0.77||||||||0.77|-0.52|
70991965|NCT03364335|141492178|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.||||||0.5485|||||||ANCOVA|||||||0.5485
70991966|NCT03364335|141492178|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.||||||0.3676|||||||ANCOVA|||||||0.3676
70991967|NCT03364335|141492179|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.||||||0.1653|||||||ANCOVA|||||||0.1653
70991968|NCT03364335|141492179|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.||||||0.197|||||||ANCOVA|||||||0.1970
70991969|NCT03364335|141492179|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.||||||0.0608|||||||ANCOVA|||||||0.0608
70991970|NCT03364335|141492179|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.||||||0.1583|||||||ANCOVA|||||||0.1583
71098903|NCT01557244|141706429|SUPERIORITY|||||||0.0298|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of urgency episodes per 24 hours and baseline weight.||||0.0298
71098904|NCT01557244|141706429|SUPERIORITY|||||||0.1417|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of urgency episodes per 24 hours and baseline weight.||||0.1417
70991971|NCT03364335|141492180|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.0524|||||||ANCOVA|||||||0.0524
70991972|NCT03364335|141492180|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.5221|||||||ANCOVA|||||||0.5221
70991973|NCT03364335|141492180|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.3702|||||||ANCOVA|||||||0.3702
70991974|NCT03364335|141492180|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.5426|||||||ANCOVA|||||||0.5426
70991975|NCT03364335|141492181|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.1843|||||||ANCOVA|||||||0.1843
70991976|NCT03364335|141492181|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.4411|||||||ANCOVA|||||||0.4411
70991977|NCT03364335|141492181|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.6991|||||||ANCOVA|||||||0.6991
70991978|NCT03364335|141492181|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.3721|||||||ANCOVA|||||||0.3721
70991979|NCT03364335|141492182|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.||||||0.0318|||||||ANCOVA|||||||0.0318
70991980|NCT03364335|141492182|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.||||||0.3827|||||||ANCOVA|||||||0.3827
70991981|NCT03364335|141492182|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.||||||0.005|||||||ANCOVA|||||||0.0050
70991982|NCT03364335|141492182|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.||||||0.1045|||||||ANCOVA|||||||0.1045
70991983|NCT02670915|141492183|NON_INFERIORITY|Stepwise hierarchical testing procedure was applied: Step 1-Primary analysis: HbA1c non-inferiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog® both in combination with insulin degludec. Non-inferiority of mealtime faster aspart was considered confirmed if the upper boundary of the two-sided 95% confidence interval (CI) was below or equal to 0.4%.|Treatment difference|-0.17|||<|0.001|TWO_SIDED|95.0|-0.3|-0.03||p-values are from the 1-sided test for non-inferiority evaluated at the 2.5% level.|Multiple imputation|Analyses were adjusted for region, strata (age), as factors, and baseline HbA1c as a covariate.||The primary analysis was implemented as a statistical model using multiple imputation where the participants without any available HbA1c measurements at scheduled visits had their change from baseline HbA1c value (s) imputed from the available information from the treatment the participant had been randomised to.||-0.03|-0.30|<0.001
71098905|NCT01557244|141706429|SUPERIORITY|||||||0.6219|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of urgency episodes per 24 hours and baseline weight.||||0.6219
71098906|NCT01557244|141706429|OTHER||Difference in LS Mean|-0.48|||||TWO_SIDED|95.0|-1.28|0.32||||||||0.32|-1.28|
71098907|NCT01557244|141706429|OTHER||Difference in LS Mean|-0.36|||||TWO_SIDED|95.0|-1.24|0.52||||||||0.52|-1.24|
70923236|NCT04093752|141337736|SUPERIORITY||Odds Ratio (OR)|48.41|||<|0.001|TWO_SIDED|95.0|25.34|92.49|||Regression, Logistic|||||92.49|25.34|<0.001
71098908|NCT01557244|141706430|SUPERIORITY|||||||0.7986|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition and baseline weight.||||0.7986
70923237|NCT04093752|141337737|SUPERIORITY||LS Mean Difference|-0.47||||0.007|TWO_SIDED|95.0|-0.81|-0.13|||ANCOVA|||Hyperglycemia||-0.13|-0.81|0.007
70923238|NCT04093752|141337737|SUPERIORITY||LS Mean Difference|-0.77|||<|0.001|TWO_SIDED|95.0|-1.11|-0.43|||ANCOVA|||Hyperglycemia||-0.43|-1.11|<0.001
70923239|NCT04093752|141337737|SUPERIORITY||LS Mean Difference|-0.71|||<|0.001|TWO_SIDED|95.0|-1.05|-0.36|||ANCOVA|||Hyperglycemia||-0.36|-1.05|<0.001
70923240|NCT04093752|141337737|SUPERIORITY||LS Mean Difference|-0.14||||0.384|TWO_SIDED|95.0|-0.46|0.18|||ANCOVA|||Hypoglycemia||0.18|-0.46|0.384
70923241|NCT04093752|141337737|SUPERIORITY||LS Mean Difference|-0.17||||0.307|TWO_SIDED|95.0|-0.49|0.16|||ANCOVA|||Hypoglycemia||0.16|-0.49|0.307
70923242|NCT04093752|141337737|SUPERIORITY||LS Mean Difference|-0.22||||0.184|TWO_SIDED|95.0|-0.55|0.11|||ANCOVA|||Hypoglycemia||0.11|-0.55|0.184
70923243|NCT04093752|141337737|SUPERIORITY||LS Mean Difference|1.81|||<|0.001|TWO_SIDED|95.0|1.03|2.59|||ANCOVA|||Treatment Satisfaction Score||2.59|1.03|<0.001
70923244|NCT04093752|141337737|SUPERIORITY||LS Mean Difference|1.63|||<|0.001|TWO_SIDED|95.0|0.84|2.41|||ANCOVA|||Treatment Satisfaction Score||2.41|0.84|<0.001
70923245|NCT04093752|141337737|SUPERIORITY||LS Mean Difference|1.68|||<|0.001|TWO_SIDED|95.0|0.89|2.47|||ANCOVA|||Treatment Satisfaction Score||2.47|0.89|<0.001
70923246|NCT01101451|141337739|SUPERIORITY||Hazard Ratio (HR)|0.6976||||0.0927|TWO_SIDED|95.0|0.408|1.192||the pre\_specified nominal significance level was 0.0451 (one sided).|Log Rank||The RFS hazard ratio estimate is for reporting group 2 vs reporting group 1.|||1.192|0.408|0.0927
70923247|NCT01101451|141337740|SUPERIORITY||Hazard Ratio (HR)|0.586|||||TWO_SIDED|95.0|0.286|1.199|||||The OS hazard ratio estimate is for reporting group 2 vs reporting group 1.|||1.199|0.286|
70923248|NCT04757610|141337751|SUPERIORITY||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|1.023||0.284421|TWO_SIDED|95.0|-3.1|0.91|||MMRM|||||0.91|-3.10|0.284421
70923249|NCT04757610|141337751|SUPERIORITY||Least Squares Mean Difference|-1.88|STANDARD_ERROR_OF_MEAN|1.025||0.066678|TWO_SIDED|95.0|-3.9|0.13|||MMRM|||||0.13|-3.90|0.066678
70923250|NCT04154384|141337770|SUPERIORITY|A comparison of the proportion of participants in each arm reporting an improvement in average pain score on the Numeric Rating Scale from baseline to 3 months follow-up.||||||0.035||||||A comparison of the proportion of participants in each arm reporting an improvement in average pain score on the Numeric Rating Scale from baseline to 12 weeks follow-up.|Chi-squared|||||||0.035
70923251|NCT05048186|141337782|OTHER||Mean Difference (Final Values)|0.06||||0.503|TWO_SIDED|95.0|-0.116|0.236|||t-test, 2 sided|||we tested to see whether SDM Process scores were different between patients who received the Decision Aid Arm vs the control arm||0.236|-0.116|0.503
70923252|NCT04218266|141337805|OTHER||Crude incidence ratio|0.42|||||TWO_SIDED|90.0|0.26|0.67||||||Comparison of the Asundexian pooled group (Asundexian 20 mg group and Asundexian 50 mg group) versus Apixaban group in all bleeding||0.67|0.26|
70923253|NCT04218266|141337807|OTHER||Crude incidence ratio|0.33|||||TWO_SIDED|90.0|0.09|0.97||||||Comparison of the Asundexian pooled group (Asundexian 20 mg group and Asundexian 50 mg group) versus Apixaban group in ISTH CRNM bleeding||0.97|0.09|
71098909|NCT01557244|141706430|SUPERIORITY|||||||0.2313|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition and baseline weight.||||0.2313
71098910|NCT01557244|141706430|SUPERIORITY|||||||0.7571|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition and baseline weight.||||0.7571
71098911|NCT01557244|141706430|OTHER||Difference in LS Mean|-0.05|||||TWO_SIDED|95.0|-42.11|42.0||||||||42.00|-42.11|
71098912|NCT01557244|141706430|OTHER||Difference in LS Mean|15.07|||||TWO_SIDED|95.0|-26.5|56.63||||||||56.63|-26.50|
71098913|NCT01557244|141706431|SUPERIORITY|||||||0.061|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per catheterization and baseline weight.||||0.0610
71098914|NCT01557244|141706431|SUPERIORITY|||||||0.0048|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per catheterization and baseline weight.||||0.0048
71098915|NCT01557244|141706431|SUPERIORITY|||||||0.01|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per catheterization and baseline weight.||||0.0100
71098916|NCT01557244|141706431|OTHER||Difference in LS Mean|-16.43|||||TWO_SIDED|95.0|-63.14|30.29||||||||30.29|-63.14|
71098917|NCT01557244|141706431|OTHER||Difference in LS Mean|1.28|||||TWO_SIDED|95.0|-46.0|48.57||||||||48.57|-46.00|
71098918|NCT01557244|141706432|SUPERIORITY|||||||0.2246|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition or catheterization and baseline weight.||||0.2246
71098919|NCT01557244|141706432|SUPERIORITY|||||||0.0003|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition or catheterization and baseline weight.||||0.0003
71098920|NCT01557244|141706432|SUPERIORITY|||||||0.0161|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition or catheterization and baseline weight.||||0.0161
71098921|NCT01557244|141706432|OTHER||Difference in LS Mean|-18.24|||||TWO_SIDED|95.0|-61.0|24.53||||||||24.53|-61.00|
71098922|NCT01557244|141706432|OTHER||Difference in LS Mean|18.86|||||TWO_SIDED|95.0|-22.93|60.65||||||||60.65|-22.93|
71098923|NCT01428713|141706468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|536.4|STANDARD_ERROR_OF_MEAN|162.12||0.01||||||P value \< 0.05 is considered significant in this study|Mixed Models Analysis||Comparing PBAC score value at baseline vs. end of 3 cycles for TA|||||0.01
71098924|NCT01428713|141706468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|430.6|STANDARD_ERROR_OF_MEAN|157.35||0.03||||||P value \< 0.05 is considered significant for this study|Mixed Models Analysis||Comparing PBAC score value at baseline vs. end of 3 cycles for COCP|||||0.03
70991984|NCT02670915|141492183|NON_INFERIORITY|Stepwise hierarchical testing procedure was applied: Step 2-Confirmatory secondary analysis: HbA1c non-inferiority of postmeal faster aspart versus mealtime NovoRapid®/NovoLog® both in combination with insulin degludec. Non-inferiority of mealtime faster aspart was considered confirmed if the upper boundary of the two-sided 95% CI was below or equal to 0.4%.|Treatment difference|0.13|||<|0.001|TWO_SIDED|95.0|-0.01|0.26||p-values are from the 1-sided test for non-inferiority evaluated at the 2.5% level.|Multiple imputation|Analyses were adjusted for region, strata (age), as factors, and baseline HbA1c as a covariate.||The analysis was implemented as a statistical model using multiple imputation where the participants without any available HbA1c measurements at scheduled visits had their change from baseline HbA1c value(s) imputed from the available information from the treatment the participant had been randomised to.||0.26|-0.01|<0.001
71039347|NCT02906917|141586751|NON_INFERIORITY|Non-inferiority of IDegAsp OD versus IGlar OD + IAsp OD was considered confirmed if the 95% confidence interval for the mean treatment difference was entirely below 0.40%.|Treatment contrast|0.07|||<|0.0001|TWO_SIDED|95.0|-0.06|0.21||One-sided p-value for test of non-inferiority.|ANCOVA|Treatment, region, sex, previous insulin treatment and previous OAD treatment as categorical fixed effects and baseline response and age as covariate.||The response and change from baseline in response are analysed on 1000 complete, imputed data sets after multiple imputation for each treatment arm separately. A penalty of 0.4% is added to the week 26 values for all premature treatment discontinued subjects, and subject with missing HbA1c values at week 26 in the IDegAsp arm. Each of the imputed data sets are analysed through an analysis of covariance (ANCOVA).||0.21|-0.06|<0.0001
71039348|NCT00874822|141586771|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|19.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|95.0|13.6|24.4|||Chi-squared, Corrected|||"Ho: The Prevalence of obstructive sleep apnea in patients planning hip or knee arthroplasty will be no different using current screening techniques than it was in a historical control group.~The prevalence of OSA in the study population is hypothesized to be at least 10% higher than the best previous estimate of 6.7%. Employing a two-sided hypothesis test with α of 0.05 and power of 0.85 yields a sample size of 163."||24.4|13.6|<0.0001
71039349|NCT04281472|141586817|SUPERIORITY||Hazard Ratio (HR)|0.394|||||TWO_SIDED|95.0|0.253|0.614||||||||0.614|0.253|
71039350|NCT01728636|141586909|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||.05
71039351|NCT01196390|141586923|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.85|TWO_SIDED|95.0|0.69|1.36|||Log Rank|Two-sided significance level = 0.05|Reference level = Chemoradiation arm|Assuming a median DFS time of 15 months (Arm 2), hypothesized increase in DFS corresponding to median DFS time of 25 months (Arm 1). Assuming an exponential distribution and constant hazards, 183 HER2-positive participants accrued over 5 years and followed for 3 years would result in 162 disease-free survival events and provide 90% statistical power to detect this difference with a 2-sided α of 0.05 and 2 interim analyses. See Limitations and Caveats section.||1.36|0.69|0.85
71098925|NCT01428713|141706468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.6|STANDARD_ERROR_OF_MEAN|5.08||0.03||||||P value \< 0.05 is considered significant for this study|Mixed Models Analysis||Comparing Peds QL score value at baseline vs. end of 3 cycles for TA|||||0.03
70991985|NCT02670915|141492183|SUPERIORITY|Stepwise hierarchical testing procedure was applied: Step 3-Confirmatory secondary analysis: HbA1c superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog® both in combination with insulin degludec. Superiority of mealtime faster aspart was considered confirmed if the upper boundary of the two-sided 95% CI was below 0.|Treatment difference|-0.17|||=|0.007|TWO_SIDED|95.0|-0.3|-0.03||p-values are from the 1-sided test for superiority evaluated at the 2.5% level.|multiple imputation|Analyses were adjusted for region, strata (age), as factors, and baseline HbA1c as a covariate.||The analysis was implemented as a statistical model using multiple imputation where the participants without any available HbA1c measurements at scheduled visits had their change from baseline HbA1c value(s) imputed from the available information from the treatment the participant had been randomised to.||-0.03|-0.30|=0.007
70991986|NCT00818207|141492263|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.0007|TWO_SIDED|95.0|1.23|2.18|||Regression, Logistic|||Odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.||2.18|1.23|0.0007
70991987|NCT00818207|141492264|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.0018|TWO_SIDED|95.0|1.21|2.33|||Regression, Logistic|||Odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.||2.33|1.21|0.0018
70991988|NCT00818207|141492265|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.2979|TWO_SIDED|95.0|0.82|1.9||p-value was not adjusted for multiple comparisons.|Regression, Logistic|||Week 39 odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.||1.90|0.82|0.2979
70991989|NCT00818207|141492265|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.4388|TWO_SIDED|95.0|0.76|1.87||p-value was not adjusted for multiple comparisons.|Regression, Logistic|||Week 52 odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.||1.87|0.76|0.4388
70991990|NCT00818207|141492266|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72|||<|0.0001|TWO_SIDED|95.0|1.35|2.2||p-value was not adjusted for multiple comparisons.|Regression, Logistic|||Odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.||2.20|1.35|<0.0001
71039352|NCT01196390|141586924|SUPERIORITY|||||||0.71|||||||Chi-squared|Two-sided significance level = 0.05||||||0.71
71039353|NCT01196390|141586925|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.95|TWO_SIDED|95.0|0.69|1.47|||Log Rank|Two-sided significance level = 0.05|Reference level = Chemoradiation arm|||1.47|0.69|0.95
71039354|NCT01196390|141586927|SUPERIORITY|||||||0.39||||||One-side significance level = 0.05|Chi-squared|||6-8 weeks||||0.39
71039355|NCT01196390|141586927|SUPERIORITY|||||||0.78||||||One-side significance level = 0.05|Chi-squared|||1 year||||0.78
71098926|NCT01428713|141706468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.75|STANDARD_ERROR_OF_MEAN|4.87||0.01|||||||Mixed Models Analysis||Comparing Peds QL score value at baseline vs. end of 3 cycles for COCP|||||0.01
71098927|NCT00871000|141706473|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: UL of the standardised asymptotic 95% CI on the group difference \[Tetravac Group minus Boostrix Polio Group\] in the percentage of subjects with anti-polio type 1 antibody titers ≥ 8 was ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.61|2.7||||||To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against poliovirus type 1, one month after vaccination.||2.7|-2.61|
71098928|NCT00871000|141706473|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: UL of the standardised asymptotic 95% CI on the group difference \[Tetravac Group minus Boostrix Polio Group\] in the percentage of subjects with anti-polio type 2 antibody titers ≥ 8 was ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.61|2.7||||||To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against polio type 2, one month after vaccination.||2.7|-2.61|
71098929|NCT00871000|141706473|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: UL of the standardised asymptotic 95% CI on the group difference \[Tetravac Group minus Boostrix Polio Group\] in the percentage of subjects with anti-polio type 3 antibody titers ≥ 8 was ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.61|2.72||||||To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against polio type 3, one month after vaccination.||2.72|-2.61|
70991991|NCT00818207|141492267|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.4551|TWO_SIDED|95.0|0.81|1.62||p-value was not adjusted for multiple comparisons.|Regression, Logistic|||Week 52 odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.||1.62|0.81|0.4551
70991992|NCT00333619|141492326|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||ANOVA|||||||0.10
70991993|NCT00333619|141492327|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||ANOVA|||||||0.12
70991994|NCT00831441|141492346|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.5094|TWO_SIDED|95.0|0.8|1.11|||Cox proportional hazard models|||A test of superiority at the one-sided α = 0.025 significance level for the primary efficacy outcome was performed.||1.11|0.80|0.5094
71098930|NCT00871000|141706474|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: Upper limit (UL) of the standardised asymptotic 95% confidence interval (CI) on the group difference \[Tetravac Group minus Boostrix Polio Group\] in the percentage of subjects with anti-D antibody concentrations ≥ 0.1 IU/mL was lower than or equal to (≤) 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.61|2.7||||||To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against diphtheria, one month after vaccination.||2.7|-2.61|
71098931|NCT00871000|141706474|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: UL of the standardised asymptotic 95% CI on the group difference \[Tetravac Group minus Boostrix Polio Group\] in the percentage of subjects with anti-T antibody concentrations ≥ 0.1 IU/mL was ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.61|2.7||||||To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against tetanus, one month after vaccination.||2.7|-2.61|
71098932|NCT01052428|141706490|SUPERIORITY_OR_OTHER|||||||0.4568||95.0|||||Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.4568
71098933|NCT01052428|141706491|SUPERIORITY_OR_OTHER|||||||0.1967||95.0||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.1967
71098934|NCT01052428|141706492|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.55
71098935|NCT01052428|141706493|SUPERIORITY_OR_OTHER|||||||0.21||95.0||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.21
71098936|NCT01052428|141706494|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.006
71098937|NCT01052428|141706495|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.16
70991995|NCT00831441|141492347|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.6702|TWO_SIDED|95.0|0.7|1.26|||Cox proportional hazard models|||||1.26|0.70|0.6702
70991996|NCT00831441|141492348|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.6311|TWO_SIDED|95.0|0.57|1.4|||Cox proportional hazard models|||||1.40|0.57|0.6311
71098938|NCT01052428|141706496|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.001
70991997|NCT00831441|141492349|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.5086|TWO_SIDED|95.0|0.76|1.14|||Cox proportional hazard models|||||1.14|0.76|0.5086
70991998|NCT00831441|141492350|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.1502|TWO_SIDED|95.0|0.47|1.12|||Cox proportional hazard models|||||1.12|0.47|0.1502
70991999|NCT00831441|141492351|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.4317|TWO_SIDED|95.0|0.82|1.09|||Cox proportional hazard models|||||1.09|0.82|0.4317
70992000|NCT00831441|141492352|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.8015|TWO_SIDED|95.0|0.83|1.15|||Cox proportional hazard models|||||1.15|0.83|0.8015
70992001|NCT00831441|141492353|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.8948|TWO_SIDED|95.0|0.85|1.15|||Cox proportional hazard models|||||1.15|0.85|0.8948
70992002|NCT00831441|141492354|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.59||||0.0006|TWO_SIDED|95.0|1.5|4.46|||Cox Proportional Hazard model|||A point estimate and two-sided 95% confidence interval (CI) for relative risk, as measured by the hazard ratio and a p-value for the test of equality of rates (HR = 1) was calculated.||4.46|1.50|0.0006
70992003|NCT00831441|141492355|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.48|||<|0.0001|TWO_SIDED|95.0|1.72|3.58|||Cox Proportional Hazard model|||||3.58|1.72|<0.0001
71098939|NCT03400787|141706497|SUPERIORITY|||||||0.0001||||||p\<0.025 indicates statistical significance.|t-test, 1 sided|||Null hypothesis is that the responder rate for the Latera implant treatment was not superior to the sham treatment. A maximum sample size of 124 evaluable subjects is required for 90% power and preserving a 2.5% (one-sided) type I error rate.||||0.0001
71098940|NCT01644331|141706553|SUPERIORITY_OR_OTHER|||||||0.315|||||||Chi-squared|||||||0.315
71098941|NCT01644331|141706554|SUPERIORITY_OR_OTHER||Slope|0.19||||0.021|TWO_SIDED|95.0|0.03|0.34|||Mixed Models Analysis|||This is a repeated measures analysis so all rows (visits) are taken into account.||0.34|0.03|0.021
71098942|NCT01644331|141706555|SUPERIORITY_OR_OTHER||Slope|0.99||||0.43|TWO_SIDED|95.0|-1.47|3.44|||Mixed Models Analysis|||This a repeated measure analysis so all rows (visits) are taken into account.||3.44|-1.47|0.430
71098943|NCT01644331|141706556|SUPERIORITY_OR_OTHER||Slope|-493.21||||0.157|TWO_SIDED|95.0|-1176.96|190.55|||Mixed Models Analysis|||This is a repeated measures analysis so all rows (visits) are taken into account.||190.55|-1176.96|0.157
70992004|NCT00831441|141492356|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.64|||<|0.0001|TWO_SIDED|95.0|1.87|3.72|||Cox Proportional Hazard model|||||3.72|1.87|<0.0001
70992005|NCT00831441|141492357|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.36|||<|0.0001|TWO_SIDED|95.0|2.06|2.7|||Cox Proportional Hazard model|||||2.70|2.06|<0.0001
70992006|NCT02338492|141492369|SUPERIORITY|||||||0.615||||||P-value not adjusted for multiple comparisons as the second co-primary endpoint will only be tested if the p-value for VAS improvement is \<0.05.|Mixed Models Analysis|Mixed model repeated measures (MMRM) model employed, including the baseline VAS score. Missing values will be imputed.||Null hypothesis: Mean improvement in VAS over 90 days \<= 53.8 (i.e. 80% of reference based on historical control data). The study was powered to 80% with 68 evaluable subjects, a standard deviation of 13.3 at each visit, a true mean improvement from baseline VAS across post-baseline visits of 57 and a within-patient correlation of VAS of 0.4. The historical control data comes from 4 selected articles (Gregory et al. 2011, Kim et al. 2011, Deschamps et al. 2012, and Pretell et al. 2010).||||0.615
70992007|NCT02338492|141492371|OTHER||Percentage of Subjects|100.0|||||TWO_SIDED|95.0|96.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: Subjects who had no serious device related complications||100|96|
71098944|NCT01644331|141706557|SUPERIORITY_OR_OTHER|||||||0.206|||||||Chi-squared|||This is a repeated measures analysis so all rows (visits) are taken into account.||||0.206
71098945|NCT01644331|141706558|SUPERIORITY_OR_OTHER||Kaplan Meier|0.98||||0.334|TWO_SIDED|95.0|0.96|0.99|||Log Rank|||||0.99|0.96|0.334
70992008|NCT02338492|141492371|OTHER||Percentage of Subjects|100.0|||||TWO_SIDED|95.0|96.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: No additional surgical interventions of revisions, supplements, fixations or removals||100|96|
70992009|NCT02338492|141492371|OTHER||Percentage of Subjects|98.8|||||TWO_SIDED|95.0|93.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation||100|93|
70992010|NCT02338492|141492371|OTHER||Percentage of Subjects|98.8|||||TWO_SIDED|95.0|93.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: Safety Success||100|93|
70992011|NCT02338492|141492371|OTHER||Percentage of Subjects|98.8|||||TWO_SIDED|95.0|93.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: Subjects who had no serious device related complications||100|93|
70992012|NCT02338492|141492371|OTHER||Percentage of Subjects|98.8|||||TWO_SIDED|95.0|93.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 30: No additional surgical interventions of revisions, supplements, fixations or removals||100|93|
70992013|NCT02338492|141492371|OTHER||Percentage of Subjects|96.3|||||TWO_SIDED|95.0|90.0|99.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 30: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation||99|90|
70992014|NCT02338492|141492371|OTHER||Percentage of Subjects|96.3|||||TWO_SIDED|95.0|90.0|99.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 30: Safety Success||99|90|
71098946|NCT01644331|141706559|SUPERIORITY_OR_OTHER|||||||0.148|||||||Chi-squared|||||||0.148
71098947|NCT01644331|141706560|SUPERIORITY_OR_OTHER|||||||0.334|||||||Chi-squared|||||||0.334
71098948|NCT01644331|141706561|SUPERIORITY_OR_OTHER||Slope|-0.67||||0.241|TWO_SIDED|95.0|-1.79|0.45|||Mixed Models Analysis|||This is a repeated measures analysis so all rows (visits) are taken into account.||0.45|-1.79|0.241
71098949|NCT01644331|141706562|SUPERIORITY_OR_OTHER||Slope|0.28||||0.303|TWO_SIDED|95.0|-0.26|0.82|||Mixed Models Analysis|||This is a repeated measures analysis so all rows (visits) are taken into account.||0.82|-0.26|0.303
71098950|NCT01644331|141706563|SUPERIORITY_OR_OTHER|||||||0.471||||||24 hours|Chi-squared|||||||0.471
71098951|NCT01644331|141706563|SUPERIORITY_OR_OTHER|||||||0.585||||||48 hrs|Chi-squared|||||||0.585
71098952|NCT01644331|141706563|SUPERIORITY_OR_OTHER|||||||0.12||||||72 hrs|Chi-squared|||||||0.120
71098953|NCT01644331|141706564|SUPERIORITY_OR_OTHER|||||||0.037|||||||Chi-squared|||||||0.037
71098954|NCT01644331|141706565|SUPERIORITY_OR_OTHER|||||||0.373|||||||Wilcoxon (Mann-Whitney)|||||||0.373
71098955|NCT01644331|141706566|SUPERIORITY_OR_OTHER||Kaplan Meier|0.26||||0.709|TWO_SIDED|95.0|0.21|0.32|||Log Rank|||||0.32|0.21|0.709
70992015|NCT02338492|141492371|OTHER||Percentage of Subjects|96.3|||||TWO_SIDED|95.0|90.0|99.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 90: Subjects who had no serious device related complications||99|90|
70992016|NCT02338492|141492371|OTHER||Percentage of Subjects|98.8|||||TWO_SIDED|95.0|93.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 90: No additional surgical interventions of revisions, supplements, fixations or removals||100|93|
71098956|NCT02327143|141706569|SUPERIORITY_OR_OTHER||Ratio of geometric least squares|0.448|||||TWO_SIDED|90.0|0.395|0.508|||||Absolute bioavailability of LY2835219 following the administration of 200 mg LY2835219 (oral) with 0.4 mg \[13C8\]-LY2835219 (IV).|||0.508|0.395|
71098957|NCT02070380|141706580|SUPERIORITY_OR_OTHER||∆Percentage MH better minus DM better|47.6|||<|0.0001|TWO_SIDED|95.0|34.5|60.7||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed-rank test.||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman's general approximate normal method.|"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus postdose paired global assessment."||60.7|34.5|<0.0001
71098958|NCT02070380|141706580|SUPERIORITY_OR_OTHER||∆Percentage MH better minus DM better|7.3||||0.1295|TWO_SIDED|95.0|-2.0|16.5||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed-rank test.||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman's general approximate normal method.|"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus post-dose paired global assessment."||16.5|-2.0|0.1295
71098959|NCT02070380|141706580|SUPERIORITY_OR_OTHER||∆Percentage MH better minus DM better|79.0|||<|0.0001|TWO_SIDED|95.0|67.1|91.0||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman's general approximate normal method.|"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus postdose paired global assessment"||91.0|67.1|<0.0001
70992017|NCT02338492|141492371|OTHER||Percentage of Subjects|93.8|||||TWO_SIDED|95.0|86.0|98.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 90: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation||98|86|
70992018|NCT02338492|141492371|OTHER||Percentage of Subjects|92.6|||||TWO_SIDED|95.0|85.0|97.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 90: Safety Success||97|85|
70992019|NCT02338492|141492371|OTHER||Percentage of Subjects|93.8|||||TWO_SIDED|95.0|86.0|98.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 180: Subjects who had no serious device related complications||98|86|
70992020|NCT02338492|141492371|OTHER||Percentage of Subjects|95.1|||||TWO_SIDED|95.0|88.0|99.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 180: No additional surgical interventions of revisions, supplements, fixations or removals||99|88|
71098960|NCT02070380|141706580|SUPERIORITY_OR_OTHER||Percentage MH better minus DM better|-2.1||||0.7503|TWO_SIDED|95.0|-15.0|10.7||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman's general approximate normal method.|"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus post-dose paired global assessment."||10.7|-15.0|0.7503
71098961|NCT02070380|141706580|SUPERIORITY_OR_OTHER||∆Percentage MH better minus DM better|66.1|||<|0.0001|TWO_SIDED|95.0|52.8|79.5||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman's general approximate normal method.|"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus post-dose paired global assessment"||79.5|52.8|<0.0001
71098962|NCT02070380|141706580|SUPERIORITY_OR_OTHER||∆Percentage MH better minus DM better|-2.1||||0.7297|TWO_SIDED|95.0|-13.8|9.6||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman's general approximate normal method.|"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus post-dose paired global assessment."||9.6|-13.8|0.7297
71098963|NCT02070380|141706581|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed-rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
71098964|NCT02070380|141706581|SUPERIORITY_OR_OTHER|||||||0.8238||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed-rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus post-dose paired global assessment."||||0.8238
71098965|NCT02070380|141706581|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
70992021|NCT02338492|141492371|OTHER||Percentage of Subjects|86.4|||||TWO_SIDED|95.0|77.0|93.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 180: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation||93|77|
70992022|NCT02338492|141492371|OTHER||Percentage of Subjects|86.4|||||TWO_SIDED|95.0|77.0|93.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 180: Safety Success||93|77|
71098966|NCT02070380|141706581|SUPERIORITY_OR_OTHER|||||||0.4597||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus postdose paired global assessment."||||0.4597
71098967|NCT02070380|141706581|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
71098968|NCT02070380|141706581|SUPERIORITY_OR_OTHER|||||||0.8145||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus postdose paired global assessment."||||0.8145
70992023|NCT02338492|141492371|OTHER||Percentage of Subjects|91.4|||||TWO_SIDED|95.0|83.0|96.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 360: Subjects who had no serious device related complications||96|83|
70992024|NCT02338492|141492371|OTHER||Percentage of Subjects|91.4|||||TWO_SIDED|95.0|83.0|96.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 360: No additional surgical interventions of revisions, supplements, fixations or removals||96|83|
70992025|NCT02338492|141492371|OTHER||Percentage of Subjects|82.7|||||TWO_SIDED|95.0|73.0|90.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 360: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation||90|73|
70992026|NCT02338492|141492371|OTHER||Percentage of Subjects|82.7|||||TWO_SIDED|95.0|73.0|90.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 360: Safety Success||90|73|
70992027|NCT03709810|141492384|SUPERIORITY||Geometric Mean Ratio|0.19|||<|0.0001|TWO_SIDED|95.0|0.12|0.3|||ANOVA|Log10 peanuts mass as response variable, study product and period as fixed explanatory effects, and participant as a random effect.|GMR=(Experimental denture adhesive/ No Adhesive)|||0.30|0.12|<0.0001
70992028|NCT04507867|141492389|OTHER|Kaplan-Meier method for overall survival.||||||0.027|||||||Log Rank|||The total number of patients who did or did not survive to day 40 of follow-up.||||0.027
70992029|NCT04507867|141492391|OTHER|Kaplan-Meier method||||||0.495|||||||Log Rank|||the total number of patients who were intubated and survived at the end of day 40 follow-up.||||0.495
70992030|NCT04507867|141492393|OTHER|Kaplan-Meier method||||||0.186|||||||Log Rank|||total number of patients included in the study who progressed to mechanical ventilation during the first 10 days of hospital stay.||||0.186
70992031|NCT04507867|141492394|SUPERIORITY|Fisher exact test||||||0.35|||||||Fisher Exact|||Intergroup analysis between the control group and the intervention group, measured at day 3 of hospital stay. It was categorized as follows: 1. normal bristol scale at day 3; 2. abnormal bristol scale at day 3.||||0.35
70992032|NCT04507867|141492395|SUPERIORITY|||||||0.043|||||||t-test, 1 sided|||Intergroup analysis between the control group and the intervention group, measured at day 3 of hospital stay . Deceased patients were excluded.||||0.043
70992033|NCT04507867|141492396|SUPERIORITY|||||||0.241|||||||Fisher Exact|||Intergroup analysis between the control group and the intervention group for different parameters, measured at day 3 of hospital stay . Deceased patients were excluded.||||0.241
70992034|NCT04507867|141492397|SUPERIORITY|||||||0.187|||||||t-test, 2 sided|||Intragroup analysis at the control group, the measurement was performed at baseline and at hospital discharge.||||0.187
70992035|NCT04507867|141492397|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||Intragroup analysis at the intervention group, the measurement was performed at baseline and at hospital discharge.||||0.003
70992036|NCT04507867|141492398|SUPERIORITY|||||||0.919|||||||t-test, 2 sided|||Intragroup analysis of the control group in oxygen delivery, the difference between the baseline period and day 3 of hospital stay.||||0.919
70992037|NCT04507867|141492398|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||Intragroup analysis of the control group in oxygen delivery, the difference between the baseline period and day 3 of hospital stay.||||0.014
70992038|NCT04507867|141492399|SUPERIORITY|||||||0.608|||||||Wilcoxon (Mann-Whitney)|||Intragroup analysis of the control group, the difference in the qSOFA measurement at baseline and at day 3 will be analyzed.||||0.608
70992039|NCT04507867|141492399|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Intragroup analysis of the intervention group, the difference in the qSOFA measurement at baseline and at day 3 will be analyzed.||||0.04
70992040|NCT04507867|141492400|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||Intergroup analysis between both groups to evaluate the number of defecations measured at day 3.||||0.014
70992041|NCT04507867|141492401|SUPERIORITY|||||||0.008|||||||Fisher Exact|the shapiro wilk test was used to analyze the distribution of the data.||Intergroup analysis between the control group and the intervention group for different parameters, measured at day 3 of hospital stay. Deceased patients were excluded.||||0.008
70992042|NCT04507867|141492403|SUPERIORITY|Intergroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days. Deceased patients were excluded.||||||0.078|||||||Fisher Exact|||||||0.078
70992043|NCT04507867|141492404|SUPERIORITY|||||||0.098|||||||t-test, 1 sided|||Intergroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days. Deceased patients were excluded||||0.098
70992044|NCT04507867|141492405|OTHER|||||||0.195|||||||Fisher Exact|||Intergroup analysis between the control group and the intervention group to analyze the presentation of post covid syndrome at the end of follow-up at day 40.||||0.195
70992045|NCT04507867|141492406|SUPERIORITY|||||||0.135|||||||Fisher Exact|||Intergroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days. Deceased patients were excluded.||||0.135
70992046|NCT04507867|141492407|SUPERIORITY|||||||0.266|||||||Fisher Exact|||Intergroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days. Deceased patients were excluded.||||0.266
70992047|NCT04507867|141492408|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.002|||||||Fisher Exact|||||||0.002
70992048|NCT04507867|141492409|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.003|||||||Fisher Exact|||||||0.003
70992049|NCT04507867|141492410|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.004|||||||Fisher Exact|||||||0.004
70992050|NCT04507867|141492411|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.011|||||||Fisher Exact|||||||0.011
70992051|NCT04507867|141492412|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.031|||||||Fisher Exact|||||||0.031
70992052|NCT04507867|141492413|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.04|||||||Fisher Exact|||||||0.040
71039356|NCT01196390|141586927|SUPERIORITY|||||||0.28||||||One-side significance level = 0.05|Chi-squared|||2 years||||0.28
71039357|NCT01196390|141586930|SUPERIORITY||Odds Ratio (OR)|2.35||||0.021|TWO_SIDED|95.0|1.13|4.86|||Regression, Logistic|||Logistic regression was used to model the association of treatment arm (Arm 1 vs. 2 \[reference level(RL)\]), T stage (T3 vs.T1,T2 \[RL\]), Zubrod (1,2 vs. 0 \[RL\]), gender (male vs. female \[RL\]), presence of adenopathy (yes vs. no \[RL\]), and age (≥ 60 vs. \<60 \[RL\]) with the occurrence of any cardiac AE, using backwards step-wise model selection requiring p≤0.05 for a covariate to remain in the model. Final model covariates are reported. Age is reported here. No other covariates reported.||4.86|1.13|0.021
70992053|NCT04507867|141492414|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.047|||||||Fisher Exact|||||||0.047
70992054|NCT04096326|141492415|SUPERIORITY||Rate difference|40.6||||0.0096|TWO_SIDED|95.0|23.6|57.6||P-value was based on Cochran-Mantel-Haenszel (CMH) tests stratified by baseline GL severity at maximum frown to compare each AGN-151586 study intervention group versus placebo for each cohort.|Cochran-Mantel-Haenszel|||||57.6|23.6|0.0096
70992055|NCT04096326|141492415|SUPERIORITY||Rate difference|46.4||||0.0094|TWO_SIDED|95.0|28.0|64.9||P-value was based on CMH tests stratified by baseline GL severity at maximum frown to compare each AGN-151586 study intervention group versus placebo for each cohort.|Cochran-Mantel-Haenszel|||||64.9|28.0|0.0094
70992056|NCT04096326|141492415|SUPERIORITY||Rate difference|52.2||||0.0044|TWO_SIDED|95.0|23.6|80.8||P-value was based on CMH tests stratified by baseline GL severity at maximum frown to compare each AGN-151586 study intervention group versus placebo for each cohort.|Cochran-Mantel-Haenszel|||||80.8|23.6|0.0044
70992057|NCT04096326|141492415|SUPERIORITY||Rate difference|63.3||||0.0026|TWO_SIDED|95.0|35.2|91.5||P-value was based on CMH tests stratified by baseline GL severity at maximum frown to compare each AGN-151586 study intervention group versus placebo for each cohort.|Cochran-Mantel-Haenszel|||||91.5|35.2|0.0026
70992058|NCT04096326|141492415|SUPERIORITY||Rate difference|85.7||||0|TWO_SIDED|95.0|64.2|100.0||P-value was based on CMH tests stratified by baseline GL severity at maximum frown to compare each AGN-151586 study intervention group versus placebo for each cohort.|Cochran-Mantel-Haenszel|||||100.0|64.2|0.0000
70992059|NCT04124536|141492421|SUPERIORITY||Risk Difference (RD)|-21.9|||||TWO_SIDED|95.0|-35.9|-7.9|||||The risk difference was calculated by subtracting the proportion of women meeting the outcome in the intervention arm minus the proportion of women meeting the outcome in the control arm|||-7.9|-35.9|
70992060|NCT04124536|141492421|SUPERIORITY||Risk Difference (RD)|-30.7|||||TWO_SIDED|95.0|-40.6|-20.8|||||The risk difference was calculated by subtracting the proportion of women meeting the outcome in the intervention arm minus the proportion of women meeting the outcome in the control arm|||-20.8|-40.6|
70992061|NCT04124536|141492422|SUPERIORITY||Risk Difference (RD)|-5.4|||||TWO_SIDED|95.0|-13.6|2.8|||||The risk difference was calculated by subtracting the proportion of women meeting the outcome in the intervention arm minus the proportion of women meeting the outcome in the control arm|||2.8|-13.6|
70992062|NCT04124536|141492422|SUPERIORITY||||||||||||||||||The calculation of risk differences between study arms was originally planned. However, the linear-binomial model did not converge because of zero events in the intervention arm.|||
70992063|NCT04124536|141492426|SUPERIORITY||Risk Difference (RD)|40.7|||||TWO_SIDED|95.0|23.0|58.4|||||The risk difference was calculated by subtracting the proportion of women meeting the outcome in the intervention arm minus the proportion of women meeting the outcome in the control arm|||58.4|23.0|
70992064|NCT04124536|141492426|SUPERIORITY||Risk Difference (RD)|23.3|||||TWO_SIDED|95.0|10.7|36.0|||||The risk difference was calculated by subtracting the proportion of women meeting the outcome in the intervention arm minus the proportion of women meeting the outcome in the control arm|||36.0|10.7|
70992065|NCT02512068|141492436|SUPERIORITY||Least square (LS) mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.124|<|0.0001|TWO_SIDED|95.0|-0.966|-0.473|||ANCOVA|||||-0.473|-0.966|<0.0001
70992066|NCT02512068|141492439|OTHER||Point estimate|-0.28|||||TWO_SIDED|95.0|-0.385|-0.18||||||Change from baseline in HbA1c at Week 2 was compared between the treatment groups.||-0.180|-0.385|
70992067|NCT02512068|141492439|OTHER||Point estimate|-0.48|||||TWO_SIDED|95.0|-0.621|-0.338||||||Change from baseline in HbA1c at Week 4 was compared between the treatment groups.||-0.338|-0.621|
70992068|NCT02512068|141492439|OTHER||Point estimate|-0.58|||||TWO_SIDED|95.0|-0.797|-0.367||||||Change from baseline in HbA1c at Week 8 was compared between the treatment groups.||-0.367|-0.797|
70992069|NCT02512068|141492439|OTHER||Point estimate|-0.71|||||TWO_SIDED|95.0|-0.975|-0.441||||||Change from baseline in HbA1c at Week 12 was compared between the treatment groups.||-0.441|-0.975|
70992070|NCT02512068|141492439|OTHER||Point estimate|-0.7|||||TWO_SIDED|95.0|-0.948|-0.452||||||Change from baseline in HbA1c at End of Treatment Period I was compared between the treatment groups.||-0.452|-0.948|
70992071|NCT02512068|141492440|OTHER||Point estimate|1.7|||||TWO_SIDED|95.0|-6.598|9.919||||||The data of participants achieving \<6.0% at the end of Treatment Period I were compared between the treatment groups.||9.919|-6.598|
70992072|NCT02512068|141492440|OTHER||Point estimate|32.9|||||TWO_SIDED|95.0|14.194|51.66||||||The data of participants achieving \<7.0% at the end of Treatment Period I were compared between the treatment groups.||51.660|14.194|
70992073|NCT02512068|141492440|OTHER||Point estimate|45.6|||||TWO_SIDED|95.0|15.528|75.7||||||The data of participants achieving \<8.0% at the end of Treatment Period I were compared between the treatment groups.||75.700|15.528|
70992074|NCT02512068|141492441|OTHER||Point estimate|-15.2|||||TWO_SIDED|95.0|-23.59|-6.88||||||Change from baseline in fasting plasma glucose at Week 2 was compared between the treatment groups.||-6.88|-23.59|
70992075|NCT02512068|141492441|OTHER||Point estimate|-8.7|||||TWO_SIDED|95.0|-20.98|3.58||||||Change from baseline in fasting plasma glucose at Week 4 was compared between the treatment groups.||3.58|-20.98|
70992076|NCT02512068|141492441|OTHER||Point estimate|-8.3|||||TWO_SIDED|95.0|-18.76|2.11||||||Change from baseline in fasting plasma glucose at Week 8 was compared between the treatment groups.||2.11|-18.76|
70992077|NCT02512068|141492441|OTHER||Point estimate|-15.6|||||TWO_SIDED|95.0|-27.14|-4.03||||||Change from baseline in fasting plasma glucose at Week 12 was compared between the treatment groups.||-4.03|-27.14|
70992078|NCT02512068|141492441|OTHER||Point estimate|-15.6|||||TWO_SIDED|95.0|-26.67|-4.62||||||Change from baseline in fasting plasma glucose at End of Treatment Period I was compared between the treatment groups.||-4.62|-26.67|
70992079|NCT02512068|141492442|OTHER||Point estimate|-1.76|||||TWO_SIDED|95.0|-2.184|-1.34||||||Change from baseline in glycoalbumin at Week 2 was compared between the treatment groups.||-1.340|-2.184|
70992080|NCT02512068|141492442|OTHER||Point estimate|-2.45||||||95.0|-3.03|-1.87||||||Change from baseline in glycoalbumin at Week 4 was compared between the treatment groups.||-1.870|-3.030|
70992081|NCT02512068|141492442|OTHER||Point estimate|-2.48|||||TWO_SIDED|95.0|-3.289|-1.679||||||Change from baseline in glycoalbumin at Week 8 was compared between the treatment groups.||-1.679|-3.289|
70992082|NCT02512068|141492442|OTHER||Point estimate|-2.66|||||TWO_SIDED|95.0|-3.608|-1.715||||||Change from baseline in glycoalbumin at Week 12 was compared between the treatment groups.||-1.715|-3.608|
70992083|NCT02512068|141492442|OTHER||Point estimate|-2.66|||||TWO_SIDED|95.0|-3.608|-1.715||||||Change from baseline in glycoalbumin at End of Treatment Period I was compared between the treatment groups.||-1.715|-3.608|
71039358|NCT03790137|141586942|OTHER|The frequency of HWE for each patient was reported as episodes/day, as determined by dividing the total number of seizures experienced over a given time period by the number of days for which seizures were recorded. Paired t-tests were performed to compare each patient's baseline seizure frequency to their seizure frequency in the last month of treatment. Change in seizure frequency is reported as percent change from baseline. An alpha of 0.05 was used for statistical significance.|||||<|0.001|||||||t-test, 1 sided|||||||<0.001
70992084|NCT01962714|141492467|NON_INFERIORITY|The primary outcome of non-inferiority of LKM relative to CPT-C was assessed using a non-inferiority margin of 5 points on the CAPS-5, which represents 0.5 SD of baseline PTSD symptoms based on data indicating the SD of baseline CAPS-5 scores is approximately 10 in a large sample (N=198) of treatment-seeking veterans.|Mean Difference (Final Values)|2.09|||||TWO_SIDED|95.0|-2.59|6.78|||||Non-inferiority of LKM to CPT-C was analyzed as the change rate from baseline to 6-month follow-up between groups (CPT-C minus LKM), with a positive value indicating a greater reduction in scores for LKM compared to CPT-C.|The non-inferiority of LKM with respect to CPT-C was analyzed using the 95% confidence interval for the group x time interaction term, with non-inferiority of LKM to CPT-C claimed if the lower limit of the 95% confidence interval was greater than (i.e., did not extend beyond) negative delta.||6.78|-2.59|
70992085|NCT01962714|141492468|NON_INFERIORITY|For depression, the non-inferiority margin was 4 points on the PROMIS depression measure, which has been defined as the minimally important difference and corresponds to a Cohen's d effect size of approximately 0.50.|Mean Difference (Final Values)|2.34|||||TWO_SIDED|95.0|-0.52|5.2|||||Non-inferiority of LKM with respect to CPT-C was analyzed as the change rate from baseline to 6-month follow-up between groups (CPT-C minus LKM), with a positive value indicating a greater reduction in scores from baseline for LKM compared to CPT-C.|The non-inferiority of LKM with respect to CPT-C was analyzed using the 95% confidence interval for the group x time interaction term, with non-inferiority of LKM to CPT-C claimed if the lower limit of the 95% confidence interval was greater than (i.e., did not extend beyond) negative delta.||5.20|-0.52|
70992086|NCT01151579|141492469|NON_INFERIORITY_OR_EQUIVALENCE|A total of at least 400 treatemnts or 65 patients was required to achieve 94% power to determine a 1% change by treatment or a 5% change between groups to be significant at p-value of 0.01 and o.05, respectively.|Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.5||0.01|TWO_SIDED|95.0|||||Mixed Models Analysis|||Null Hypothesis: No difference between groups in heart rate changes from baseline following treatment. Sample size calculation determined a need for at least 400 breathing treatments among 65 patients.||||0.01
70992087|NCT01151579|141492470|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.05|TWO_SIDED|95.0||||Analysis adjusted with Fischer exact chi-square for rare occurrences.|Chi-squared|||Null hypothesis: no difference in incidence of arrhythmias between groups within the total number of breathing treatments.||||0.05
70992088|NCT01151579|141492471|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||descriptive|Descriptive statistics (frequency) used to report the number of participants experiencing an event.||To report on the number of events.||||0
70992089|NCT01098461|141492481|NON_INFERIORITY_OR_EQUIVALENCE|The p-value is from a two-sided t-test for the difference in means. Dunnett's method is used to adjust for multiple comparisons.|Mean Difference (Final Values)|-0.89|||<|0.0001|TWO_SIDED|95.0|-1.22|-0.57|||t-test, 2 sided|||||-0.57|-1.22|<0.0001
70992090|NCT01098461|141492481|NON_INFERIORITY_OR_EQUIVALENCE|The p-value is from a two-sided t-test for the difference in means. Dunnett's method is used to adjust for multiple comparisons.|Mean Difference (Final Values)|-1.55|||<|0.0001|TWO_SIDED|95.0|-1.88|-1.23|||t-test, 2 sided|||||-1.23|-1.88|<0.0001
71098969|NCT02070380|141706582|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus postdose paired global assessment."||||0.0020
71098970|NCT02070380|141706582|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus post-dose paired global assessment."||||1.0000
71098971|NCT02070380|141706582|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus postdose paired global assessment."||||0.0001
70923254|NCT04218266|141337808|OTHER||Crude incidence ratio|0.47|||||TWO_SIDED|90.0|0.28|0.83||||||Comparison of the Asundexian pooled group (Asundexian 20 mg group and Asundexian 50 mg group) versus Apixaban group in ISTH minor bleeding||0.83|0.28|
70992091|NCT01098461|141492481|NON_INFERIORITY_OR_EQUIVALENCE|The p-value is from a two-sided t-test for the difference in means. Dunnett's method is used to adjust for multiple comparisons.|Mean Difference (Final Values)|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.43|-0.78|||t-test, 2 sided|||||-0.78|-1.43|<0.0001
70992092|NCT03807739|141492560|EQUIVALENCE|Equivalence margin 80% - 125%|Geometric LS Mean Ratio|1.2471|||||TWO_SIDED|90.0|1.1149|1.3951||||||||1.3951|1.1149|
70992093|NCT03807739|141492560|EQUIVALENCE|Equivalence margin 80% - 125%|Geometric LS Mean Ratio|0.9864|||||TWO_SIDED|90.0|0.8531|1.1405||||||||1.1405|0.8531|
70992094|NCT03807739|141492562|EQUIVALENCE|Equivalence margin 80% - 125%|Geometric LS Mean Ratio|1.2203|||||TWO_SIDED|90.0|1.1175|1.3327||||||||1.3327|1.1175|
70992095|NCT03807739|141492562|EQUIVALENCE|Equivalence margin 80% - 125%|Geometric LS Mean Ratio|0.9947|||||TWO_SIDED|90.0|0.8266|1.1968||||||||1.1968|0.8266|
70992096|NCT00516269|141492622|SUPERIORITY_OR_OTHER||mean difference in treat versus control|0.42|STANDARD_DEVIATION|3.3||0.54||95.0|||||Wilcoxon signed rank test|||As a crossover study, the potential carryover effect was examined first. The pooled data (the 2-week treatment for each intervention i.e. period 1 \& period 2) was used to assess the treatment effect (A versus B).||||0.54
70992097|NCT01552928|141492632|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||ANCOVA|||||||0.004
70992098|NCT01552928|141492632|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
70992099|NCT01552928|141492632|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
71098972|NCT02070380|141706582|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus postdose paired global assessment."||||1.0000
71098973|NCT02070380|141706582|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
70992100|NCT01552928|141492633|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
70992101|NCT01552928|141492633|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
70992102|NCT01552928|141492633|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
70992103|NCT01552928|141492634|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|||||||ANCOVA|||||||0.012
70992104|NCT01552928|141492634|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044|||||||ANCOVA|||||||0.044
70992105|NCT01552928|141492634|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
70992106|NCT01552928|141492635|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
70992107|NCT01552928|141492635|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
70992108|NCT01552928|141492635|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
70992109|NCT01552928|141492636|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||ANCOVA|||||||0.003
70992110|NCT01552928|141492636|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
70992111|NCT01552928|141492636|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043|||||||ANCOVA|||||||0.043
70992112|NCT01552928|141492641|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
70992113|NCT01552928|141492641|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
70992114|NCT01552928|141492641|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
70992115|NCT01552928|141492642|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
70992116|NCT01552928|141492642|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
70992117|NCT01552928|141492642|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||ANCOVA|||||||0.004
70992118|NCT01552928|141492643|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||ANCOVA|||||||0.005
70992119|NCT01552928|141492643|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
70992120|NCT01552928|141492643|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
70992121|NCT01552928|141492644|SUPERIORITY_OR_OTHER_LEGACY|||||||0.078|||||||ANCOVA|||||||0.078
70992122|NCT01552928|141492644|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
70992123|NCT01552928|141492644|SUPERIORITY_OR_OTHER_LEGACY|||||||0.156|||||||ANCOVA|||||||0.156
70992124|NCT01552928|141492645|SUPERIORITY_OR_OTHER_LEGACY|||||||0.439|||||||ANCOVA|||||||0.439
70992125|NCT01552928|141492645|SUPERIORITY_OR_OTHER_LEGACY|||||||0.274|||||||ANCOVA|||||||0.274
70992126|NCT01552928|141492645|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
70992127|NCT04030104|141492646|SUPERIORITY|||||||0.0268||||||Threshold for statistical significance \<0.05|Random Reader, Random Mass|Curve Fitting Method: Empirical||||||0.0268
70992128|NCT04570657|141492650|SUPERIORITY||LS mean difference|0.036||||0.267|TWO_SIDED|80.0|-0.038|0.111||One-sided p-value|MMRM||Tozorakimab Dose A - Placebo|||0.111|-0.038|0.267
70992129|NCT04570657|141492650|SUPERIORITY||LS mean difference|0.004||||0.473|TWO_SIDED|80.0|-0.071|0.079||One-sided p-value|MMRM||Tozorakimab Dose B - Placebo|||0.079|-0.071|0.473
70992130|NCT04570657|141492651|SUPERIORITY||LS mean difference|-0.012||||0.437|TWO_SIDED|80.0|-0.11|0.086||One-sided p-value|MMRM||Week 8: Tozorakimab Dose A - Placebo|||0.086|-0.110|0.437
70992131|NCT04570657|141492651|SUPERIORITY||LS mean difference|0.059||||0.221|TWO_SIDED|80.0|-0.039|0.157||One-sided p-value|MMRM||Week 8: Tozorakimab Dose B - Placebo|||0.157|-0.039|0.221
70992132|NCT04570657|141492651|SUPERIORITY||LS mean difference|-0.038||||0.308|TWO_SIDED|80.0|-0.136|0.06||One-sided p-value|MMRM||Week 16: Tozorakimab Dose A - Placebo|||0.060|-0.136|0.308
70992133|NCT04570657|141492651|SUPERIORITY||LS mean difference|-0.025||||0.372|TWO_SIDED|80.0|-0.122|0.072||One-sided p-value|MMRM||Week 16: Tozorakimab Dose B - Placebo|||0.072|-0.122|0.372
70992134|NCT04570657|141492654|SUPERIORITY||LS mean difference|-0.03||||0.416|TWO_SIDED|80.0|-0.215|0.154||One-sided p-value|MMRM||Tozorakimab Dose A - Placebo|||0.154|-0.215|0.416
70992135|NCT04570657|141492654|SUPERIORITY||LS mean difference|-0.047||||0.371|TWO_SIDED|80.0|-0.231|0.137||One-sided p-value|MMRM||Tozorakimab Dose B - Placebo|||0.137|-0.231|0.371
70992136|NCT04570657|141492655|SUPERIORITY||Odds Ratio (OR)|1.2||||0.612|TWO_SIDED|80.0|0.76|1.9|||Chi-squared|||||1.90|0.76|0.612
70992137|NCT04570657|141492655|SUPERIORITY||Odds Ratio (OR)|1.41||||0.348|TWO_SIDED|80.0|0.88|2.25|||Chi-squared|||||2.25|0.88|0.348
70992138|NCT04570657|141492656|SUPERIORITY||Odds Ratio (OR)|0.81||||0.575|TWO_SIDED|80.0|0.5|1.31|||Chi-squared|||||1.31|0.50|0.575
70992139|NCT04570657|141492656|SUPERIORITY||Odds Ratio (OR)|0.86||||0.679|TWO_SIDED|80.0|0.53|1.38|||Chi-squared|||||1.38|0.53|0.679
70992140|NCT04570657|141492657|SUPERIORITY||LS mean difference|0.002||||0.5|TWO_SIDED|80.0|-3.825|3.828||One-sided p-value|MMRM||SGRQ Activity Total Score: Tozorakimab Dose A - Placebo|||3.828|-3.825|0.500
70992141|NCT04570657|141492657|SUPERIORITY||LS mean difference|-1.364||||0.324|TWO_SIDED|80.0|-5.198|2.47||One-sided p-value|MMRM||SGRQ Activity Total Score: Tozorakimab Dose B - Placebo|||2.470|-5.198|0.324
70992142|NCT04570657|141492657|SUPERIORITY||LS mean difference|-1.421||||0.248|TWO_SIDED|80.0|-4.103|1.26||One-sided p-value|MMRM||SGRQ Impacts Total Score: Tozorakimab Dose A - Placebo|||1.260|-4.103|0.248
70992143|NCT04570657|141492657|SUPERIORITY||LS mean difference|-1.694||||0.21|TWO_SIDED|80.0|-4.383|0.996||One-sided p-value|MMRM||SGRQ Impacts Total Score: Tozorakimab Dose B - Placebo|||0.996|-4.383|0.210
70992144|NCT04570657|141492657|SUPERIORITY||LS mean difference|0.691||||0.42|TWO_SIDED|80.0|-3.715|5.096||One-sided p-value|MMRM||SGRQ Symptoms Total Score: Tozorakimab Dose A - Placebo|||5.096|-3.715|0.420
70992145|NCT04570657|141492657|SUPERIORITY||LS mean difference|-3.15||||0.181|TWO_SIDED|80.0|-7.579|1.28||One-sided p-value|MMRM||SGRQ Symptoms Total Score: Tozorakimab Dose B - Placebo|||1.280|-7.579|0.181
70992146|NCT04570657|141492657|SUPERIORITY||LS mean difference|-0.663||||0.38|TWO_SIDED|80.0|-3.454|2.129||One-sided p-value|MMRM||SGRQ Total Score: Tozorakimab Dose A - Placebo|||2.129|-3.454|0.380
70992147|NCT04570657|141492657|SUPERIORITY||LS mean difference|-1.896||||0.192|TWO_SIDED|80.0|-4.694|0.903||One-sided p-value|MMRM||SGRQ Total Score: Tozorakimab Dose B - Placebo|||0.903|-4.694|0.192
70992148|NCT04570657|141492658|SUPERIORITY||Odds Ratio (OR)|0.93||||0.828|TWO_SIDED|80.0|0.59|1.46|||Chi-squared|||||1.46|0.59|0.828
71098974|NCT02070380|141706582|SUPERIORITY_OR_OTHER|||||||0.5811|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus postdose paired global assessment."||||0.5811
70992149|NCT04570657|141492658|SUPERIORITY||Odds Ratio (OR)|1.07||||0.84|TWO_SIDED|80.0|0.68|1.7|||Chi-squared|||||1.70|0.68|0.840
70992150|NCT04570657|141492659|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.239|TWO_SIDED|80.0|0.8|2.0||One-sided p-value|Regression, Cox|Cox regression model with treatment group, background medication, geographic region, and ICS total daily dose as covariates.||||2.0|0.8|0.239
70992151|NCT04570657|141492659|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.461|TWO_SIDED|80.0|0.6|1.7||One-sided p-value|Regression, Cox|Cox regression model with treatment group, background medication, geographic region, and ICS total daily dose as covariates.||||1.7|0.6|0.461
70992152|NCT04570657|141492660|SUPERIORITY||Rate ratio|0.87||||0.346|TWO_SIDED|80.0|0.56|1.36||One-sided p-value|Negative binomial regression|||||1.36|0.56|0.346
70992153|NCT04570657|141492660|SUPERIORITY||Rate ratio|0.7||||0.166|TWO_SIDED|80.0|0.43|1.12||One-sided p-value|Negative binomial regression|||||1.12|0.43|0.166
70992154|NCT04570657|141492661|SUPERIORITY||Geometric LS mean ratio|0.869||||0.029|TWO_SIDED|80.0|0.791|0.956||One-sided p-value|MMRM|||||0.956|0.791|0.029
71098975|NCT02070380|141706583|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
70992155|NCT04570657|141492661|SUPERIORITY||Geometric LS mean ratio|0.879||||0.04|TWO_SIDED|80.0|0.8|0.966||One-sided p-value|MMRM|||||0.966|0.800|0.040
70992156|NCT04570657|141492662|SUPERIORITY||LS mean difference|0.023||||0.385|TWO_SIDED|80.0|-0.078|0.124||One-sided p-value; alpha = 0.1|MMRM||Tozorakimab Dose A - Placebo|1 Exacerbation in Last 12 Months||0.124|-0.078|0.385
70992157|NCT04570657|141492662|SUPERIORITY||LS mean difference|-0.123||||0.06|TWO_SIDED|80.0|-0.224|-0.022||One-sided p-value; alpha = 0.1|MMRM||Tozorakimab Dose B - Placebo|1 Exacerbation in Last 12 Months||-0.022|-0.224|0.060
70992158|NCT04570657|141492662|SUPERIORITY||LS mean Difference|0.077||||0.186|TWO_SIDED|80.0|-0.034|0.187||One-sided p-value; alpha = 0.1|MMRM||Tozorakimab Dose A - Placebo|≥ 2 Exacerbation in Last 12 Months||0.187|-0.034|0.186
70992159|NCT04570657|141492662|SUPERIORITY||LS mean difference|0.212||||0.007|TWO_SIDED|80.0|0.102|0.322||One-sided p-value; alpha = 0.1|MMRM||Tozorakimab Dose B - Placebo|≥ 2 Exacerbation in Last 12 Months||0.322|0.102|0.007
70992160|NCT04570657|141492663|SUPERIORITY||Geometric LS Mean Ratio|0.63|||<|0.001|TWO_SIDED|80.0|0.559|0.71||One-sided p-value|MMRM|||Analysis at Week 16 based on MMRM which included fixed effects for baseline, background medication, geographic region, baseline ICS total daily dose, visit, treatment and the baseline by visit and treatment by visit interactions.||0.710|0.559|< 0.001
70992161|NCT04570657|141492663|SUPERIORITY||Geometric LS Mean Ratio|0.675|||<|0.001|TWO_SIDED|80.0|0.599|0.76||One-sided p-value|MMRM|||Analysis at Week 16 based on MMRM which included fixed effects for baseline, background medication, geographic region, baseline ICS total daily dose, visit, treatment and the baseline by visit and treatment by visit interactions.||0.760|0.599|< 0.001
70992162|NCT01072539|141492666|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical significant level: 0.05|Fisher Exact|||Comparison among subgroups of Infection Sites: cSSSI, cIAI, CAP, cIAI + cSSSI, and cIAI + CAP.||||<0.0001
70992163|NCT01072539|141492667|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0067||||||Statistical significant level: 0.05|Chi-squared|||Geriatrc: \<65 Years Versus (VS) Geriatrc: \>=65 Years||||0.0067
70992164|NCT01072539|141492667|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0412||||||Statistical significant level: 0.05|Chi-squared|||Comparison among Age categories: \<30 Years, 30 to 39 Years, 40 to 49 Years, 50 to 64 Years, and \>=65 Years.||||0.0412
70992165|NCT01072539|141492667|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4792||||||Statistical significant level: 0.05|Chi-squared|||Sex: Male VS Sex: Female||||0.4792
70992166|NCT01072539|141492667|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9669||||||Statistical significant level: 0.05|Chi-squared|||Comparson among Duration of Disease categories: \<3 Months, \>=3 Months and \<6 Months, and \>=6 Months||||0.9669
70992167|NCT01072539|141492667|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0064||||||Statistical significant level: 0.05|Fisher Exact|||Comparison among subgroups of infection site: cSSSI, cIAI, CAP, cIAI + cSSSI, and cIAI + CAP.||||0.0064
70992168|NCT01072539|141492667|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Satistical significant level: 0.05|Chi-squared|||Comparison among severity of infection subgroups: Mild, Moderate, and Severe.||||<0.0001
70992169|NCT01072539|141492667|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical significant level: 0.05|Chi-squared|||General Medical History: Yes VS General Medical History: No||||<0.0001
70992170|NCT01072539|141492667|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical significant level: 0.05|Chi-squared|||General Medical History (Present): Yes VS General Medical History (Present): No||||<0.0001
70992171|NCT01072539|141492667|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006||||||Statistical significant level: 0.05|Chi-squared|||General Medical History (Past): Yes VS General Medical History (Past): No||||0.0006
70992172|NCT01072539|141492667|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Chi-squared|||Kidney Disorder: Yes VS Kidney Disorder: No||||<0.0001
70992173|NCT01072539|141492667|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical significant level: 0.05|Chi-squared|||Liver Disorder: Yes VS Liver Disorder: No||||<0.0001
70992174|NCT01072539|141492667|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0153||||||Statistical significant level: 0.05|Chi-squared|||Comparison among subgroups of Total Treatment Period of Tygacil: \<7 Days, 7 to 14 Days, and \>14 Days||||0.0153
70992175|NCT01072539|141492667|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical significant level 0.05|Fisher Exact|||Comparison among subgroups of Mean Daily Dose of Tygacil: \<50 mg, 50 to \<100 mg, 100 to \<200 mg, and \>=200 mg.||||<0.0001
70992176|NCT01072539|141492667|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0376||||||Statistical significant level: 0.05|Chi-squared|||Past Medication and Therapy: Yes VS Past Medication and Therapy: No||||0.0376
70992177|NCT01072539|141492667|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical significant level: 0.05|Chi-squared|||Concomitant Medications: Yes VS Concomitant Medications: No||||<0.0001
70992178|NCT02856269|141492669|OTHER|Wilcoxon rank sum tests, X2 tests, Fisher exact tests, Kolmogorov-Smirnov|Cohen's D value|0.8|||||TWO_SIDED||||||||The Cohen's d is calculated after Box-Cox transformation. Small effect \<= 0.2, Medium effect \[0.3, 0.8\]; Large effect \>0.8|||||
70992179|NCT01752842|141492679|SUPERIORITY|Power calculation is based on assumption that treatment with Fenofibrate will lead to 11% decrease in plasma TG and ceramide biomarkers. We also assume that there will be no significant change in ceramides without intervention. Based on these assumptions, 86 subjects are required to have 90% chance of detecting a decrease in the primary outcome measure from 1.29 in the placebo group to 1.15 in the Fenofibrate group.|Mean Difference (Final Values)|-0.75||||0.07|TWO_SIDED|95.0|-1.56|0.04||This P-value is based on ANCOVA.|ANCOVA||ANCOVA was used to compare mean change of cardiac diastolic function adjusting for body fat percent, baseline values of BMI, diastolic/systolic blood pressure, HbA1c, fasting glucose, triglycerides, ethnicity, gender and race.|Null hypothesis is no difference of mean change of cardiac diastolic function as measured by E' (cm/s) between placebo and Fenofibrate.|Two-sample t-test was used to compare baseline mean values of biomarkers. All statistical tests are two-sided at significance level 0.05.|0.04|-1.56|0.07
70992180|NCT01752842|141492680|SUPERIORITY|Power calculation is based on assumption that treatment with Fenofibrate will lead to 11% decrease in plasma TG and ceramide biomarkers. We also assume that there will be no significant change in ceramides without intervention. Based on these assumptions, 86 subjects are required to have 90% chance of detecting a decrease in the primary outcome measure from 1.29 in the placebo group to 1.15 in the Fenofibrate group.|Mean Difference (Final Values)|0.0058||||0.8128|TWO_SIDED|95.0|-0.0418|0.0543||This P-value is based on ANCOVA.|ANCOVA||ANCOVA was used to compare mean change of outcome adjusting for body fat percent, demographic variables and baseline biomarkers.|Null hypothesis is no difference of mean change of fractional shortening percent between placebo and Fenofibrate.|Two-sample t-test was used to compare baseline mean values of biomarkers. All statistical tests are two-sided at significance level 0.05.|0.0543|-0.0418|0.8128
70992181|NCT01752842|141492681|SUPERIORITY|Power calculation is based on assumption that treatment with Fenofibrate will lead to 11% decrease in plasma TG and ceramide biomarkers. We also assume that there will be no significant change in ceramides without intervention. Based on these assumptions, 86 subjects are required to have 90% chance of detecting a decrease in the primary outcome measure from 1.29 in the placebo group to 1.15 in the Fenofibrate group.|Mean Difference (Final Values)|-1.79||||0.0034|TWO_SIDED|95.0|-2.93|-0.65||This P-value is based on ANCOVA.|ANCOVA|ANCOVA was used to compare mean change of outcome adjusting for body fat percent, demographic variables and baseline biomarkers.||Null hypothesis is no difference of mean change of C24:0/C16:0 ceramide ratio between placebo and Fenofibrate.|Two-sample t-test was used to compare baseline mean values of biomarkers. All statistical tests are two-sided at significance level 0.05.|-0.65|-2.93|0.0034
71039359|NCT05194202|141586963|OTHER|||||||0.622|||||||one-sample test of proportions|Hypothesis was evaluated using a one-tailed, one-proportion z-test.||Our null hypothesis for the acceptability was P0 great than or equal to 85% vs. the alternative P0 less than 85%. Acceptability responses were dichotomized to include neutral with strongly disagree/disagree.||||.622
70992182|NCT01683071|141492682|SUPERIORITY||LSMD|2.9||||0.9494|TWO_SIDED|95.0|-88.0|94.0|||ANCOVA|||||94|-88|0.9494
70992183|NCT01683071|141492682|SUPERIORITY||LSMD|-103.3||||0.0237|TWO_SIDED|95.0|-192.0|-14.0|||ANCOVA|||||-14|-192|0.0237
70992184|NCT01683071|141492682|SUPERIORITY||LSMD|-94.3||||0.0386|TWO_SIDED|95.0|-184.0|-5.0|||ANCOVA|||||-5|-184|0.0386
70992185|NCT01683071|141492682|SUPERIORITY||LSMD|-96.5|||<|0.0001|TWO_SIDED|95.0|-144.0|-49.0|||ANCOVA|||||-49|-144|<0.0001
70992186|NCT01683071|141492683|SUPERIORITY||Geometric LSM ratio|0.9||||0.6182|TWO_SIDED|95.0|0.6|1.3|||ANOVA|||||1.3|0.6|0.6182
70992187|NCT01683071|141492683|SUPERIORITY||Geometric LSM ratio|0.73||||0.1097|TWO_SIDED|95.0|0.5|1.1|||ANOVA|||||1.1|0.5|0.1097
70992188|NCT01683071|141492683|SUPERIORITY||Geometric LSM ratio|0.85||||0.4046|TWO_SIDED|95.0|0.6|1.3|||ANOVA|||||1.3|0.6|0.4046
70992189|NCT01683071|141492683|SUPERIORITY||Geometric LSM ratio|0.74||||0.0016|TWO_SIDED|95.0|0.6|0.9|||ANOVA|||||0.9|0.6|0.0016
70992190|NCT02020031|141492686|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Comparison at approximately 3 minutes, adjusted by BMI, age, and length of surgical procedure.||||<0.0001
70992191|NCT02020031|141492686|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Comparison at approximately 30 minutes, adjusted by BMI, age, and length of surgical procedure.||||<0.0001
70992192|NCT02020031|141492686|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Comparison at approximately 50 minutes, adjusted by BMI, age, and length of surgical procedure.||||<0.0001
70992193|NCT02020031|141492686|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Comparison at approximately 115 minutes, adjusted by BMI, age, and length of surgical procedure.||||<0.0001
70992194|NCT02020031|141492686|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Comparison at approximately 150 minutes, adjusted by BMI, age, and length of surgical procedure.||||<0.0001
70992195|NCT02020031|141492686|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Comparison at approximately 180 minutes, adjusted by BMI, age, and length of surgical procedure.||||<0.0001
70992196|NCT04047121|141492688|SUPERIORITY|||||||0.2531|||||||Chi-squared|||||||0.2531
70992197|NCT04047121|141492688|SUPERIORITY|||||||0.0295|||||||Chi-squared|||||||0.0295
70992198|NCT04047121|141492688|SUPERIORITY|||||||0.1857|||||||Chi-squared|||||||0.1857
71039360|NCT05194202|141586964|OTHER|||||||0.038|||||||one sample test of proportions|Hypothesis was evaluated using a one-tailed, one-proportion z-test||Our null hypothesis for the acceptabnility of the ED-Heart was P0 great than or equal to 85% vs. the alternative P0 less than 85%. Acceptability responses were dichotomized to include neutral with strongly disagree/disagree.||||.038
70923255|NCT04218266|141337809|OTHER||Crude incidence ratio|0.33|||||TWO_SIDED|90.0|0.09|0.97|||Other|||Comparison of the Asundexian pooled group (Asundexian 20 mg group and Asundexian 50 mg group) versus Apixaban group in ISTH major bleeding or CRNM bleeding||0.97|0.09|
70923256|NCT02742519|141337810|SUPERIORITY|||||||0.2121|||||||t-test, 2 sided|||||||0.2121
70992199|NCT04047121|141492688|SUPERIORITY||Odds Ratio (OR)|0.8401||||0.3297|TWO_SIDED|95.0|0.5919|1.1925|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.1925|0.5919|0.3297
70992200|NCT04047121|141492688|SUPERIORITY||Odds Ratio (OR)|1.5066||||0.2003|TWO_SIDED|95.0|0.8046|2.8209|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||2.8209|0.8046|0.2003
70992201|NCT04047121|141492688|SUPERIORITY||Odds Ratio (OR)|1.4052||||0.2276|TWO_SIDED|95.0|0.8086|2.442|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||2.4420|0.8086|0.2276
70992202|NCT04047121|141492689|SUPERIORITY|||||||0.8786|||||||Chi-squared|||||||0.8786
70992203|NCT04047121|141492689|SUPERIORITY|||||||0.1178|||||||Chi-squared|||||||0.1178
71039361|NCT03930849|141586977|OTHER||F-value for Type 3 Fixed, df=4|2.01||||0.1|TWO_SIDED||||||Mixed Models Analysis|P-value is for F-value reported below of group x time term in a mixed methods analysis.||||||0.10
71039362|NCT03930849|141586978|SUPERIORITY||F statistic GroupxTime, df=4|0.025||||0.9|TWO_SIDED||||||Mixed Models Analysis|P-value is for F-value reported below of group x time analysis in a mixed methods analysis.||||||0.90
71039363|NCT03930849|141586979|SUPERIORITY||F Value Group x Time, DF=4|2.12||||0.08|TWO_SIDED|||||P-value of F statistic reported below for mixed methods analysis group\*time interaction term.|Mixed Models Analysis|||||||0.08
70923257|NCT03580369|141337822|SUPERIORITY||LS Mean|-8.002|STANDARD_ERROR_OF_MEAN|1.313|<|0.0001|TWO_SIDED|95.0|-10.576|-5.428|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults||-5.428|-10.576|<.0001
70923258|NCT03580369|141337822|SUPERIORITY||LS mean|0.672|STANDARD_ERROR_OF_MEAN|0.939||0.7628|TWO_SIDED|95.0|-1.169|2.513|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults||2.513|-1.169|0.7628
70992204|NCT04047121|141492689|SUPERIORITY|||||||0.5337|||||||Chi-squared|||||||0.5337
70992205|NCT04047121|141492689|SUPERIORITY||Odds Ratio (OR)|1.0283||||0.9212|TWO_SIDED|95.0|0.5911|1.789|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.7890|0.5911|0.9212
70992206|NCT04047121|141492689|SUPERIORITY||Odds Ratio (OR)|0.7464||||0.4693|TWO_SIDED|95.0|0.338|1.6482|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.6482|0.3380|0.4693
70992207|NCT04047121|141492689|SUPERIORITY||Odds Ratio (OR)|0.8212||||0.5593|TWO_SIDED|95.0|0.4239|1.591|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.5910|0.4239|0.5593
70992208|NCT04047121|141492690|SUPERIORITY|||||||0.6205|||||||Chi-squared|||||||0.6205
70992209|NCT04047121|141492690|SUPERIORITY|||||||0.4924|||||||Chi-squared|||||||0.4924
70992210|NCT04047121|141492690|SUPERIORITY|||||||0.4982|||||||Chi-squared|||||||0.4982
70992211|NCT04047121|141492690|SUPERIORITY||Odds Ratio (OR)|1.3182||||0.5494|TWO_SIDED|95.0|0.5335|3.257|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||3.2570|0.5335|0.5494
70992212|NCT04047121|141492690|SUPERIORITY||Odds Ratio (OR)|1.1664||||0.783|TWO_SIDED|95.0|0.39|3.4883|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||3.4883|0.3900|0.7830
70992213|NCT04047121|141492691|SUPERIORITY|||||||0.3817|||||||Chi-squared|||||||0.3817
70992214|NCT04047121|141492691|SUPERIORITY|||||||0.7397|||||||Chi-squared|||||||0.7397
70992215|NCT04047121|141492691|SUPERIORITY|||||||0.7942|||||||Chi-squared|||||||0.7942
70992216|NCT04047121|141492691|SUPERIORITY||Odds Ratio (OR)|1.0682||||0.7924|TWO_SIDED|95.0|0.6537|1.7455|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.7455|0.6537|0.7924
70992217|NCT04047121|141492691|SUPERIORITY||Odds Ratio (OR)|1.0414||||0.9339|TWO_SIDED|95.0|0.3997|2.7134|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||2.7134|0.3997|0.9339
70992218|NCT04047121|141492691|SUPERIORITY||Odds Ratio (OR)|0.8195||||0.6497|TWO_SIDED|95.0|0.347|1.935|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.9350|0.3470|0.6497
70992219|NCT04047121|141492692|SUPERIORITY|||||||0.7936|||||||Chi-squared|||||||0.7936
70992220|NCT04047121|141492692|SUPERIORITY|||||||0.5621|||||||Chi-squared|||||||0.5621
70992221|NCT04047121|141492692|SUPERIORITY|||||||0.68|||||||Chi-squared|||||||0.6800
71039364|NCT00660387|141586980|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-1.91|STANDARD_ERROR_OF_MEAN|0.57||0.0015|TWO_SIDED|95.0|-3.05|-0.76||Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline and the natural logarithm of the mean daily dose of rescue medication on valid symptom diary days as covariates.|ANCOVA|||||-0.76|-3.05|0.0015
70992222|NCT04047121|141492692|SUPERIORITY||Odds Ratio (OR)|1.1438||||0.5051|TWO_SIDED|95.0|0.7705|1.6978|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.6978|0.7705|0.5051
70992223|NCT04047121|141492692|SUPERIORITY||Odds Ratio (OR)|0.8576||||0.7131|TWO_SIDED|95.0|0.3781|1.9452|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.9452|0.3781|0.7131
70992224|NCT04047121|141492692|SUPERIORITY||Odds Ratio (OR)|0.8415||||0.649|TWO_SIDED|95.0|0.4003|1.769|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.7690|0.4003|0.6490
70992225|NCT04047121|141492693|SUPERIORITY|||||||0.5217|||||||Chi-squared|||||||0.5217
70992226|NCT04047121|141492693|SUPERIORITY|||||||0.0432|||||||Chi-squared|||||||0.0432
70992227|NCT04047121|141492693|SUPERIORITY|||||||0.2573|||||||Chi-squared|||||||0.2573
70992228|NCT04047121|141492693|SUPERIORITY||Odds Ratio (OR)|1.1637||||0.5368|TWO_SIDED|95.0|0.7193|1.8827|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.8827|0.7193|0.5368
70992229|NCT04047121|141492693|SUPERIORITY||Odds Ratio (OR)|0.7757||||0.4685|TWO_SIDED|95.0|0.3904|1.5413|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.5413|0.3904|0.4685
70992230|NCT04047121|141492693|SUPERIORITY||Odds Ratio (OR)|0.7354||||0.3112|TWO_SIDED|95.0|0.4057|1.333|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.3330|0.4057|0.3112
70992231|NCT04047121|141492694|SUPERIORITY|||||||0.8122|||||||Log Rank|||||||0.8122
70992232|NCT04047121|141492694|SUPERIORITY|||||||0.7766|||||||Log Rank|||||||0.7766
70992233|NCT04047121|141492694|SUPERIORITY|||||||0.8305|||||||Log Rank|||||||0.8305
70992234|NCT04047121|141492694|SUPERIORITY||Hazard Ratio (HR)|0.5814||||0.1845|TWO_SIDED|95.0|0.261|1.2952|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.2952|0.2610|0.1845
70992235|NCT04047121|141492694|SUPERIORITY||Hazard Ratio (HR)|1.5908||||0.2951|TWO_SIDED|95.0|0.6671|3.7936|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||3.7936|0.6671|0.2951
70992236|NCT04047121|141492694|SUPERIORITY||Hazard Ratio (HR)|1.3546||||0.4907|TWO_SIDED|95.0|0.6584|2.787|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||2.7870|0.6584|0.4907
70992237|NCT04047121|141492695|SUPERIORITY|||||||0.6006|||||||Log Rank|||||||0.6006
70992238|NCT04047121|141492695|SUPERIORITY|||||||0.2941|||||||Log Rank|||||||0.2941
70992239|NCT04047121|141492695|SUPERIORITY|||||||0.961|||||||Log Rank|||||||0.9610
70992240|NCT04047121|141492695|SUPERIORITY||Hazard Ratio (HR)|0.5571||||0.0455|TWO_SIDED|95.0|0.314|0.9884|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||0.9884|0.3140|0.0455
70992241|NCT04047121|141492695|SUPERIORITY||Hazard Ratio (HR)|2.1781||||0.0274|TWO_SIDED|95.0|1.0904|4.3506|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||4.3506|1.0904|0.0274
70992242|NCT04047121|141492695|SUPERIORITY||Hazard Ratio (HR)|0.8896||||0.6787|TWO_SIDED|95.0|0.5114|1.5475|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.5475|0.5114|0.6787
70992243|NCT04047121|141492696|SUPERIORITY|||||||0.9084|||||||Log Rank|||||||0.9084
70992244|NCT04047121|141492696|SUPERIORITY|||||||0.8325|||||||Log Rank|||||||0.8325
70992245|NCT04047121|141492696|SUPERIORITY|||||||0.963|||||||Log Rank|||||||0.9630
70992246|NCT04047121|141492696|SUPERIORITY||Hazard Ratio (HR)|1.0508||||0.7909|TWO_SIDED|95.0|0.7284|1.516|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.5160|0.7284|0.7909
70992247|NCT04047121|141492696|SUPERIORITY||Hazard Ratio (HR)|0.8117||||0.6027|TWO_SIDED|95.0|0.37|1.7808|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.7808|0.3700|0.6027
70992248|NCT04047121|141492696|SUPERIORITY||Hazard Ratio (HR)|1.1742||||0.6978|TWO_SIDED|95.0|0.5222|2.6404|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||2.6404|0.5222|0.6978
70992249|NCT04047121|141492697|SUPERIORITY|||||||0.1736|||||||Log Rank|||||||0.1736
70992250|NCT04047121|141492697|SUPERIORITY|||||||0.0195|||||||Log Rank|||||||0.0195
70992251|NCT04047121|141492697|SUPERIORITY|||||||0.2104|||||||Log Rank|||||||0.2104
71098976|NCT02070380|141706583|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus post-dose paired global assessment."||||1.0000
70992252|NCT04047121|141492697|SUPERIORITY||Hazard Ratio (HR)|1.1723||||0.167|TWO_SIDED|95.0|0.9357|1.4687|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.4687|0.9357|0.1670
70992253|NCT04047121|141492697|SUPERIORITY||Hazard Ratio (HR)|0.7228||||0.1087|TWO_SIDED|95.0|0.4861|1.0747|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.0747|0.4861|0.1087
70992254|NCT04047121|141492697|SUPERIORITY||Hazard Ratio (HR)|0.8402||||0.3212|TWO_SIDED|95.0|0.5957|1.1852|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.1852|0.5957|0.3212
70992255|NCT04047121|141492698|SUPERIORITY|||||||0.9361|||||||Chi-squared|||||||0.9361
70992256|NCT04047121|141492698|SUPERIORITY|||||||0.3851|||||||Chi-squared|||||||0.3851
70992257|NCT04047121|141492698|SUPERIORITY|||||||0.599|||||||Chi-squared|||||||0.5990
70992258|NCT04047121|141492698|SUPERIORITY||Odds Ratio (OR)|0.9954||||0.986|TWO_SIDED|95.0|0.5962|1.662|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.6620|0.5962|0.9860
70992259|NCT04047121|141492698|SUPERIORITY||Odds Ratio (OR)|1.2959||||0.5813|TWO_SIDED|95.0|0.5158|3.2558|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||3.2558|0.5158|0.5813
70992260|NCT04047121|141492698|SUPERIORITY||Odds Ratio (OR)|1.8182||||0.1789|TWO_SIDED|95.0|0.7604|4.3473|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||4.3473|0.7604|0.1789
70992261|NCT04047121|141492699|SUPERIORITY|||||||0.4009|||||||Chi-squared|||||||0.4009
70992262|NCT04047121|141492699|SUPERIORITY|||||||0.9765|||||||Chi-squared|||||||0.9765
70992263|NCT04047121|141492699|SUPERIORITY|||||||0.2849|||||||Chi-squared|||||||0.2849
70992264|NCT04047121|141492699|SUPERIORITY||Odds Ratio (OR)|0.8252||||0.5289|TWO_SIDED|95.0|0.4538|1.5007|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.5007|0.4538|0.5289
70992265|NCT04047121|141492699|SUPERIORITY||Odds Ratio (OR)|0.9408||||0.927|TWO_SIDED|95.0|0.2553|3.4678|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.4678|0.2553|0.9270
70992266|NCT04047121|141492699|SUPERIORITY||Odds Ratio (OR)|0.3968||||0.0707|TWO_SIDED|95.0|0.1456|1.0812|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.0812|0.1456|0.0707
70992267|NCT04047121|141492700|SUPERIORITY|||||||0.2061|||||||Chi-squared|||||||0.2061
70992268|NCT04047121|141492700|SUPERIORITY|||||||0.1908|||||||Chi-squared|||||||0.1908
70992269|NCT04047121|141492701|SUPERIORITY|||||||0.8033|||||||Chi-squared|||||||0.8033
70992270|NCT04047121|141492701|SUPERIORITY|||||||0.6669|||||||Chi-squared|||||||0.6669
70992271|NCT04047121|141492701|SUPERIORITY|||||||0.6477|||||||Chi-squared|||||||0.6477
70992272|NCT04047121|141492701|SUPERIORITY||Odds Ratio (OR)|0.7948||||0.5509|TWO_SIDED|95.0|0.3736|1.6907|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.6907|0.3736|0.5509
70992273|NCT04047121|141492701|SUPERIORITY||Odds Ratio (OR)|0.6814||||0.6216|TWO_SIDED|95.0|0.1486|3.125|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.1250|0.1486|0.6216
70992274|NCT04047121|141492701|SUPERIORITY||Odds Ratio (OR)|0.6974||||0.5506|TWO_SIDED|95.0|0.2135|2.2781|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.2781|0.2135|0.5506
70992275|NCT04047121|141492702|SUPERIORITY|||||||0.103|||||||Chi-squared|||||||0.1030
70992276|NCT04047121|141492702|SUPERIORITY|||||||0.9317|||||||Chi-squared|||||||0.9317
70992277|NCT04047121|141492702|SUPERIORITY|||||||0.242|||||||Chi-squared|||||||0.2420
70992278|NCT04047121|141492702|SUPERIORITY||Odds Ratio (OR)|1.7474||||0.0869|TWO_SIDED|95.0|0.9222|3.3107|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.3107|0.9222|0.0869
70992279|NCT04047121|141492702|SUPERIORITY||Odds Ratio (OR)|1.1346||||0.8228|TWO_SIDED|95.0|0.3757|3.4266|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.4266|0.3757|0.8228
70923259|NCT03580369|141337822|SUPERIORITY||LS Mean|-7.964|STANDARD_ERROR_OF_MEAN|1.305|<|0.0001|TWO_SIDED|95.0|-10.522|-5.047|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults||-5.047|-10.522|<.0001
70923260|NCT03580369|141337822|SUPERIORITY||LS mean|0.71|STANDARD_ERROR_OF_MEAN|0.933||0.7768|TWO_SIDED|95.0|-1.118|2.538|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults||2.538|-1.118|0.7768
70923261|NCT03580369|141337824|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|5.68|||<|0.0001|TWO_SIDED|95.0|2.667|12.095|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||12.095|2.667|<.0001
70923262|NCT03580369|141337824|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|0.84||||0.843|TWO_SIDED|95.0|0.598|1.18|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||1.180|0.598|0.8430
70923263|NCT03580369|141337824|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|5.734|||<|0.0001|TWO_SIDED|95.0|2.694|12.207|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||12.207|2.694|<.0001
70923264|NCT03580369|141337824|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio, log|0.848||||0.8312|TWO_SIDED|95.0|0.605|1.188|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||1.188|0.605|0.8312
70992280|NCT04047121|141492702|SUPERIORITY||Odds Ratio (OR)|1.565||||0.4855|TWO_SIDED|95.0|0.4446|5.5086|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||5.5086|0.4446|0.4855
70992281|NCT04047121|141492704|SUPERIORITY|||||||0.5092|||||||Chi-squared|||||||0.5092
71039365|NCT00660387|141586981|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|1.86|STANDARD_ERROR_OF_MEAN|0.65||0.0059|TWO_SIDED|95.0|0.56|3.17|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||3.17|0.56|0.0059
71098977|NCT02070380|141706583|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
70923265|NCT03580369|141337825|SUPERIORITY||LS Mean|-3.1|STANDARD_ERROR_OF_MEAN|0.597|<|0.0001|TWO_SIDED|95.0|-4.271|-1.929|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Adults||-1.929|-4.271|<.0001
70923266|NCT03580369|141337825|SUPERIORITY||LS Mean|0.419|STANDARD_ERROR_OF_MEAN|0.428||0.8366|TWO_SIDED|95.0|-0.419|1.258|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Adults||1.258|-0.419|0.8366
70923267|NCT03580369|141337825|SUPERIORITY|Adults|LS Mean|-3.13|STANDARD_ERROR_OF_MEAN|0.594|<|0.0001|TWO_SIDED|95.0|-4.295|-1.966|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||||-1.966|-4.295|<.0001
70992282|NCT04047121|141492704|SUPERIORITY|||||||0.0201|||||||Chi-squared|||||||0.0201
70992283|NCT04047121|141492704|SUPERIORITY|||||||0.2799|||||||Chi-squared|||||||0.2799
70992284|NCT04047121|141492704|SUPERIORITY||Odds Ratio (OR)|0.9021||||0.5772|TWO_SIDED|95.0|0.6281|1.2958|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.2958|0.6281|0.5772
70992285|NCT04047121|141492704|SUPERIORITY||Odds Ratio (OR)|1.3953||||0.3272|TWO_SIDED|95.0|0.7166|2.7169|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.7169|0.7166|0.3272
70992286|NCT04047121|141492704|SUPERIORITY||Odds Ratio (OR)|1.3527||||0.3011|TWO_SIDED|95.0|0.763|2.3983|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.3983|0.7630|0.3011
70992287|NCT04047121|141492705|SUPERIORITY|||||||0.2931|||||||Chi-squared|||||||0.2931
70992288|NCT04047121|141492705|SUPERIORITY|||||||0.3135|||||||Chi-squared|||||||0.3135
70923268|NCT03580369|141337825|SUPERIORITY||LS Mean|0.389|STANDARD_ERROR_OF_MEAN|0.425||0.8201|TWO_SIDED|95.0|-0.444|1.222|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Adults||1.222|-0.444|0.8201
70923269|NCT03580369|141337827|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|2.747|||<|0.0001|TWO_SIDED|95.0|1.621|4.656|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||4.656|1.621|<.0001
70923270|NCT03580369|141337827|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|0.836||||0.8586|TWO_SIDED|95.0|0.603|1.159|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||1.159|0.603|0.8586
70923271|NCT03580369|141337827|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|3.261|||<|0.0001|TWO_SIDED|95.0|1.929|5.513|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||5.513|1.929|<.0001
70923272|NCT03580369|141337827|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|0.992||||0.519|TWO_SIDED|95.0|0.717|1.373|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||1.373|0.717|0.5190
70923273|NCT03580369|141337828|SUPERIORITY||Risk Ratio (RR)|1.323|||<|0.0001|TWO_SIDED|95.0|1.183|1.48|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults||1.480|1.183|<.0001
70923274|NCT03580369|141337828|SUPERIORITY||Risk Ratio (RR)|0.975||||0.7469|TWO_SIDED|95.0|0.904|1.051|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults||1.051|0.904|0.7469
70992289|NCT04047121|141492705|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
70992290|NCT04047121|141492705|SUPERIORITY||Odds Ratio (OR)|0.8369||||0.6772|TWO_SIDED|95.0|0.3618|1.9356|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.9356|0.3618|0.6772
70992291|NCT04047121|141492705|SUPERIORITY||Odds Ratio (OR)|5.253||||0.0013|TWO_SIDED|95.0|1.9061|14.477|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||14.4770|1.9061|0.0013
70992292|NCT04047121|141492706|SUPERIORITY|||||||0.5217|||||||Chi-squared|||||||0.5217
71039366|NCT00660387|141586982|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-7.0|STANDARD_ERROR_OF_MEAN|2.8||0.0155|TWO_SIDED|95.0|-12.6|-1.4||Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the CGI-Severity (CGI-S, see Baseline Characteristics module) as a covariate.|ANCOVA|||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||-1.4|-12.6|0.0155
71039367|NCT00660387|141586983|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0258|TWO_SIDED|95.0|-1.4|-0.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the baseline CGI-S as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||-0.1|-1.4|0.0258
70992293|NCT04047121|141492706|SUPERIORITY|||||||0.0432|||||||Chi-squared|||||||0.0432
70992294|NCT04047121|141492706|SUPERIORITY|||||||0.2573|||||||Chi-squared|||||||0.2573
70992295|NCT04047121|141492706|SUPERIORITY||Odds Ratio (OR)|0.8593||||0.5368|TWO_SIDED|95.0|0.5311|1.3902|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.3902|0.5311|0.5368
70992296|NCT04047121|141492706|SUPERIORITY||Odds Ratio (OR)|1.2892||||0.4685|TWO_SIDED|95.0|0.6488|2.5616|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.5616|0.6488|0.4685
70992297|NCT04047121|141492706|SUPERIORITY||Odds Ratio (OR)|1.3598||||0.3112|TWO_SIDED|95.0|0.7502|2.4648|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.4648|0.7502|0.3112
70992298|NCT04047121|141492707|SUPERIORITY|||||||0.409|||||||Chi-squared|||||||0.4090
70992299|NCT04047121|141492707|SUPERIORITY|||||||0.0249|||||||Chi-squared|||||||0.0249
70992300|NCT04047121|141492707|SUPERIORITY|||||||0.0103|||||||Chi-squared|||||||0.0103
70992301|NCT04047121|141492707|SUPERIORITY||Odds Ratio (OR)|1.1302||||0.5415|TWO_SIDED|95.0|0.763|1.6741|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.6741|0.7630|0.5415
70992302|NCT04047121|141492707|SUPERIORITY||Odds Ratio (OR)|2.0118||||0.0596|TWO_SIDED|95.0|0.9722|4.1632|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||4.1632|0.9722|0.0596
70992303|NCT04047121|141492707|SUPERIORITY||Odds Ratio (OR)|3.4823||||0.0002|TWO_SIDED|95.0|1.793|6.7633|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||6.7633|1.7930|0.0002
70992304|NCT04047121|141492708|SUPERIORITY|||||||0.2361|||||||Chi-squared|||||||0.2361
70992305|NCT04047121|141492708|SUPERIORITY|||||||0.7474|||||||Chi-squared|||||||0.7474
70992306|NCT04047121|141492708|SUPERIORITY|||||||0.2118|||||||Chi-squared|||||||0.2118
70992307|NCT04047121|141492708|SUPERIORITY||Odds Ratio (OR)|1.3811||||0.1978|TWO_SIDED|95.0|0.8449|2.2576|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.2576|0.8449|0.1978
70992308|NCT04047121|141492708|SUPERIORITY||Odds Ratio (OR)|1.0614||||0.8893|TWO_SIDED|95.0|0.4587|2.4559|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.4559|0.4587|0.8893
70992309|NCT04047121|141492708|SUPERIORITY||Odds Ratio (OR)|0.5811||||0.1553|TWO_SIDED|95.0|0.2748|1.2286|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.2286|0.2748|0.1553
70992310|NCT04047121|141492709|SUPERIORITY|||||||0.6767|||||||Chi-squared|||||||0.6767
70992311|NCT04047121|141492709|SUPERIORITY|||||||0.1141|||||||Chi-squared|||||||0.1141
70992312|NCT04047121|141492709|SUPERIORITY|||||||0.1497|||||||Chi-squared|||||||0.1497
70992313|NCT04047121|141492709|SUPERIORITY||Odds Ratio (OR)|0.8556||||0.5228|TWO_SIDED|95.0|0.5303|1.3804|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.3804|0.5303|0.5228
71098978|NCT02070380|141706583|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus postdose paired global assessment."||||1.0000
70992314|NCT04047121|141492709|SUPERIORITY||Odds Ratio (OR)|2.5125||||0.0277|TWO_SIDED|95.0|1.1062|5.7063|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||5.7063|1.1062|0.0277
70992315|NCT04047121|141492709|SUPERIORITY||Odds Ratio (OR)|0.6993||||0.324|TWO_SIDED|95.0|0.3435|1.4236|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.4236|0.3435|0.3240
70992316|NCT04047121|141492710|SUPERIORITY|||||||0.6318|||||||t-test, 2 sided|||||||0.6318
70992317|NCT04047121|141492710|SUPERIORITY|||||||0.3802|||||||t-test, 2 sided|||||||0.3802
70992318|NCT04047121|141492710|SUPERIORITY|||||||0.2424|||||||t-test, 2 sided|||||||0.2424
70992319|NCT04047121|141492710|SUPERIORITY||Odds Ratio (OR)|0.0347||||0.1753|TWO_SIDED|95.0|-0.0155|0.0848|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0848|-0.0155|0.1753
70992320|NCT04047121|141492710|SUPERIORITY||Odds Ratio (OR)|0.0194||||0.6114|TWO_SIDED|95.0|-0.0553|0.0941|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0941|-0.0553|0.6114
70992321|NCT04047121|141492710|SUPERIORITY||Odds Ratio (OR)|0.0345||||0.2977|TWO_SIDED|95.0|-0.0304|0.0993|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0993|-0.0304|0.2977
70992322|NCT04047121|141492711|SUPERIORITY|||||||0.1473|||||||t-test, 2 sided|||||||0.1473
70992323|NCT04047121|141492711|SUPERIORITY|||||||0.8747|||||||t-test, 2 sided|||||||0.8747
70992324|NCT04047121|141492711|SUPERIORITY|||||||0.5265|||||||t-test, 2 sided|||||||0.5265
70992325|NCT04047121|141492711|SUPERIORITY||Odds Ratio (OR)|-0.0457||||0.2522|TWO_SIDED|95.0|-0.1239|0.0325|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0325|-0.1239|0.2522
70992326|NCT04047121|141492711|SUPERIORITY||Odds Ratio (OR)|0.0278||||0.6701|TWO_SIDED|95.0|-0.1003|0.1559|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.1559|-0.1003|0.6701
70992327|NCT04047121|141492711|SUPERIORITY||Odds Ratio (OR)|0.1693||||0.1017|TWO_SIDED|95.0|-0.0334|0.372|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.3720|-0.0334|0.1017
70992328|NCT04047121|141492712|SUPERIORITY|||||||0.2246|||||||t-test, 2 sided|||||||0.2246
70992329|NCT04047121|141492712|SUPERIORITY|||||||0.2101|||||||t-test, 2 sided|||||||0.2101
70992330|NCT04047121|141492712|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.0030
70992331|NCT04047121|141492712|SUPERIORITY||Odds Ratio (OR)|0.414||||0.3324|TWO_SIDED|95.0|-0.4231|1.2511|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.2511|-0.4231|0.3324
70992332|NCT04047121|141492712|SUPERIORITY||Odds Ratio (OR)|1.1712||||0.1367|TWO_SIDED|95.0|-0.3713|2.7138|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.7138|-0.3713|0.1367
70992333|NCT04047121|141492712|SUPERIORITY||Odds Ratio (OR)|1.8099||||0.0028|TWO_SIDED|95.0|0.6219|2.9978|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.9978|0.6219|0.0028
70992334|NCT04047121|141492713|SUPERIORITY|||||||0.2667|||||||t-test, 2 sided|||||||0.2667
70992335|NCT04047121|141492713|SUPERIORITY|||||||0.657|||||||t-test, 2 sided|||||||0.6570
70992336|NCT04047121|141492713|SUPERIORITY|||||||0.5403|||||||t-test, 2 sided|||||||0.5403
70992337|NCT04047121|141492713|SUPERIORITY||Odds Ratio (OR)|0.9159||||0.1167|TWO_SIDED|95.0|-0.2283|2.06|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.0600|-0.2283|0.1167
70992338|NCT04047121|141492713|SUPERIORITY||Odds Ratio (OR)|-0.0336||||0.9722|TWO_SIDED|95.0|-1.9238|1.8567|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.8567|-1.9238|0.9722
70992339|NCT04047121|141492713|SUPERIORITY||Odds Ratio (OR)|0.2064||||0.8455|TWO_SIDED|95.0|-1.8689|2.2817|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.2817|-1.8689|0.8455
70992340|NCT04047121|141492714|SUPERIORITY|||||||0.3142|||||||t-test, 2 sided|||||||0.3142
70992341|NCT04047121|141492714|SUPERIORITY|||||||0.2465|||||||t-test, 2 sided|||||||0.2465
70992342|NCT04047121|141492714|SUPERIORITY|||||||0.5933|||||||t-test, 2 sided|||||||0.5933
70992343|NCT04047121|141492714|SUPERIORITY||Odds Ratio (OR)|-0.0089||||0.7815|TWO_SIDED|95.0|-0.0716|0.0538|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0538|-0.0716|0.7815
70923275|NCT03580369|141337828|SUPERIORITY||Risk Ratio (RR)|1.376|||<|0.0001|TWO_SIDED|95.0|1.23|1.54|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults||1.540|1.230|<.0001
70992344|NCT04047121|141492714|SUPERIORITY||Odds Ratio (OR)|0.0337||||0.4446|TWO_SIDED|95.0|-0.0528|0.1202|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.1202|-0.0528|0.4446
70992345|NCT04047121|141492714|SUPERIORITY||Odds Ratio (OR)|-0.0333||||0.4733|TWO_SIDED|95.0|-0.1243|0.0577|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0577|-0.1243|0.4733
70992346|NCT04047121|141492715|SUPERIORITY|||||||0.0658|||||||t-test, 2 sided|||||||0.0658
70992347|NCT04047121|141492715|SUPERIORITY|||||||0.3785|||||||t-test, 2 sided|||||||0.3785
70992348|NCT04047121|141492715|SUPERIORITY|||||||0.6202|||||||t-test, 2 sided|||||||0.6202
70992349|NCT04047121|141492715|SUPERIORITY||Odds Ratio (OR)|-0.0425||||0.2523|TWO_SIDED|95.0|-0.1154|0.0303|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0303|-0.1154|0.2523
70992350|NCT04047121|141492715|SUPERIORITY||Odds Ratio (OR)|-0.0388||||0.4068|TWO_SIDED|95.0|-0.1305|0.0529|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0529|-0.1305|0.4068
70992351|NCT04047121|141492715|SUPERIORITY||Odds Ratio (OR)|0.0706||||0.5858|TWO_SIDED|95.0|-0.1833|0.3244|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.3244|-0.1833|0.5858
70992352|NCT04047121|141492716|SUPERIORITY|||||||0.3832|||||||t-test, 2 sided|||||||0.3832
70992353|NCT04047121|141492716|SUPERIORITY|||||||0.4631|||||||t-test, 2 sided|||||||0.4631
70992354|NCT04047121|141492716|SUPERIORITY|||||||0.6202|||||||t-test, 2 sided|||||||0.6202
70992355|NCT04047121|141492716|SUPERIORITY||Odds Ratio (OR)|-0.5353||||0.3158|TWO_SIDED|95.0|-1.5812|0.5107|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.5107|-1.5812|0.3158
70992356|NCT04047121|141492716|SUPERIORITY||Odds Ratio (OR)|1.3543||||0.1016|TWO_SIDED|95.0|-0.2669|2.9755|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.9755|-0.2669|0.1016
70992357|NCT04047121|141492716|SUPERIORITY||Odds Ratio (OR)|0.8677||||0.2576|TWO_SIDED|95.0|-0.6347|2.37|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.3700|-0.6347|0.2576
70992358|NCT04047121|141492717|SUPERIORITY|||||||0.3107|||||||t-test, 2 sided|||||||0.3107
70992359|NCT04047121|141492717|SUPERIORITY|||||||0.3735|||||||t-test, 2 sided|||||||0.3735
70992360|NCT04047121|141492717|SUPERIORITY|||||||0.3863|||||||t-test, 2 sided|||||||0.3863
70992361|NCT04047121|141492717|SUPERIORITY||Odds Ratio (OR)|-1.0337||||0.1918|TWO_SIDED|95.0|-2.5858|0.5184|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.5184|-2.5858|0.1918
70992362|NCT04047121|141492717|SUPERIORITY||Odds Ratio (OR)|-0.9749||||0.4281|TWO_SIDED|95.0|-3.3864|1.4366|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.4366|-3.3864|0.4281
70992363|NCT04047121|141492717|SUPERIORITY||Odds Ratio (OR)|-1.8599||||0.1014|TWO_SIDED|95.0|-4.0854|0.3657|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.3657|-4.0854|0.1014
70992364|NCT04047121|141492718|SUPERIORITY|||||||0.4555|||||||t-test, 2 sided|||||||0.4555
70992365|NCT04047121|141492718|SUPERIORITY|||||||0.7164|||||||t-test, 2 sided|||||||0.7164
70992366|NCT04047121|141492718|SUPERIORITY|||||||0.2456|||||||t-test, 2 sided|||||||0.2456
70992367|NCT04047121|141492718|SUPERIORITY||Odds Ratio (OR)|0.0568||||0.0962|TWO_SIDED|95.0|-0.0101|0.1238|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.1238|-0.0101|0.0962
70992368|NCT04047121|141492718|SUPERIORITY||Odds Ratio (OR)|-0.0432||||0.3844|TWO_SIDED|95.0|-0.1405|0.0541|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0541|-0.1405|0.3844
70992369|NCT04047121|141492718|SUPERIORITY||Odds Ratio (OR)|0.0233||||0.5899|TWO_SIDED|95.0|-0.0615|0.1082|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.1082|-0.0615|0.5899
70992370|NCT04047121|141492719|SUPERIORITY|||||||0.4133|||||||t-test, 2 sided|||||||0.4133
70992371|NCT04047121|141492719|SUPERIORITY|||||||0.7171|||||||t-test, 2 sided|||||||0.7171
70992372|NCT04047121|141492719|SUPERIORITY|||||||0.8609|||||||t-test, 2 sided|||||||0.8609
70992373|NCT04047121|141492719|SUPERIORITY||Odds Ratio (OR)|-0.0445||||0.6224|TWO_SIDED|95.0|-0.2218|0.1327|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.1327|-0.2218|0.6224
70992374|NCT04047121|141492719|SUPERIORITY||Odds Ratio (OR)|-0.0884||||0.5655|TWO_SIDED|95.0|-0.39|0.2132|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.2132|-0.3900|0.5655
70992375|NCT04047121|141492719|SUPERIORITY||Odds Ratio (OR)|0.1809||||0.4044|TWO_SIDED|95.0|-0.2444|0.6062|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.6062|-0.2444|0.4044
70992376|NCT04047121|141492720|SUPERIORITY|||||||0.0104|||||||t-test, 2 sided|||||||0.0104
70992377|NCT04047121|141492720|SUPERIORITY|||||||0.5949|||||||t-test, 2 sided|||||||0.5949
70992378|NCT04047121|141492720|SUPERIORITY|||||||0.0801|||||||t-test, 2 sided|||||||0.0801
70992379|NCT04047121|141492720|SUPERIORITY||Odds Ratio (OR)|-3.7075||||0.0072|TWO_SIDED|95.0|-6.411|-1.004|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||-1.0040|-6.4110|0.0072
70992380|NCT04047121|141492720|SUPERIORITY||Odds Ratio (OR)|-1.4296||||0.5406|TWO_SIDED|95.0|-6.008|3.1489|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.1489|-6.0080|0.5406
70992381|NCT04047121|141492720|SUPERIORITY||Odds Ratio (OR)|-0.3527||||0.8603|TWO_SIDED|95.0|-4.279|3.5737|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.5737|-4.2790|0.8603
71039368|NCT00660387|141586984|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-3.0|STANDARD_ERROR_OF_MEAN|1.1||0.0086|TWO_SIDED|95.0|-5.3|-0.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||-0.8|-5.3|0.0086
71098979|NCT02070380|141706583|SUPERIORITY_OR_OTHER|||||||0.0023|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus postdose paired global assessment."||||0.0023
70992382|NCT04047121|141492721|SUPERIORITY|||||||0.6344|||||||t-test, 2 sided|||||||0.6344
70992383|NCT04047121|141492721|SUPERIORITY|||||||0.3037|||||||t-test, 2 sided|||||||0.3037
70992384|NCT04047121|141492721|SUPERIORITY|||||||0.1344|||||||t-test, 2 sided|||||||0.1344
70992385|NCT04047121|141492721|SUPERIORITY||Odds Ratio (OR)|1.2586||||0.5092|TWO_SIDED|95.0|-2.4787|4.9958|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||4.9958|-2.4787|0.5092
70992386|NCT04047121|141492721|SUPERIORITY||Odds Ratio (OR)|-0.7696||||0.8047|TWO_SIDED|95.0|-6.8683|5.3292|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||5.3292|-6.8683|0.8047
70992387|NCT04047121|141492721|SUPERIORITY||Odds Ratio (OR)|0.094||||0.9757|TWO_SIDED|95.0|-5.9628|6.1507|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||6.1507|-5.9628|0.9757
70992388|NCT04047121|141492722|SUPERIORITY|||||||0.0839|||||||t-test, 2 sided|||||||0.0839
70992389|NCT04047121|141492722|SUPERIORITY|||||||0.9577|||||||t-test, 2 sided|||||||0.9577
70992390|NCT04047121|141492722|SUPERIORITY|||||||0.9497|||||||t-test, 2 sided|||||||0.9497
70992391|NCT04047121|141492722|SUPERIORITY||Odds Ratio (OR)|-0.031||||0.4873|TWO_SIDED|95.0|-0.1185|0.0565|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0565|-0.1185|0.4873
70992392|NCT04047121|141492722|SUPERIORITY||Odds Ratio (OR)|-0.0312||||0.678|TWO_SIDED|95.0|-0.1783|0.1159|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.1159|-0.1783|0.6780
71098980|NCT02070380|141706583|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus postdose paired global assessment."||||1.0000
71098981|NCT02070380|141706584|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
71098982|NCT02070380|141706584|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus post-dose paired global assessment."||||1.0000
71098983|NCT02070380|141706584|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
70992393|NCT04047121|141492722|SUPERIORITY||Odds Ratio (OR)|0.0099||||0.9327|TWO_SIDED|95.0|-0.2207|0.2406|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.2406|-0.2207|0.9327
71039369|NCT00660387|141586985|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|1.4|STANDARD_ERROR_OF_MEAN|2.1||0.502|TWO_SIDED|95.0|-2.8|5.6|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||5.6|-2.8|0.5020
71098984|NCT02070380|141706584|SUPERIORITY_OR_OTHER|||||||0.7503|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus postdose paired global assessment."||||0.7503
70992394|NCT04047121|141492723|SUPERIORITY|||||||0.0021|||||||t-test, 2 sided|||||||0.0021
70923276|NCT03580369|141337828|SUPERIORITY||Risk Ratio (RR)|1.014||||0.3586|TWO_SIDED|95.0|0.941|1.092|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults||1.092|0.941|0.3586
70992395|NCT04047121|141492723|SUPERIORITY|||||||0.5396|||||||t-test, 2 sided|||||||0.5396
70992396|NCT04047121|141492723|SUPERIORITY|||||||0.6121|||||||t-test, 2 sided|||||||0.6121
70992397|NCT04047121|141492723|SUPERIORITY||Odds Ratio (OR)|-0.1895||||0.0303|TWO_SIDED|95.0|-0.361|-0.0181|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||-0.0181|-0.3610|0.0303
70992398|NCT04047121|141492723|SUPERIORITY||Odds Ratio (OR)|-0.1901||||0.1807|TWO_SIDED|95.0|-0.4685|0.0883|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0883|-0.4685|0.1807
70992399|NCT04047121|141492723|SUPERIORITY||Odds Ratio (OR)|0.1594||||0.7445|TWO_SIDED|95.0|-0.7991|1.1178|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.1178|-0.7991|0.7445
70992400|NCT04047121|141492724|SUPERIORITY|||||||0.0035|||||||t-test, 2 sided|||||||0.0035
70992401|NCT04047121|141492724|SUPERIORITY|||||||0.504|||||||t-test, 2 sided|||||||0.5040
70992402|NCT04047121|141492724|SUPERIORITY|||||||0.1366|||||||t-test, 2 sided|||||||0.1366
70992403|NCT04047121|141492724|SUPERIORITY||Odds Ratio (OR)|-3.4084||||0.082|TWO_SIDED|95.0|-7.2497|0.433|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.4330|-7.2497|0.0820
70992404|NCT04047121|141492724|SUPERIORITY||Odds Ratio (OR)|-1.5342||||0.5845|TWO_SIDED|95.0|-7.0336|3.9652|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.9652|-7.0336|0.5845
70992405|NCT04047121|141492724|SUPERIORITY||Odds Ratio (OR)|0.987||||0.7284|TWO_SIDED|95.0|-4.583|6.557|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||6.5570|-4.5830|0.7284
70992406|NCT04047121|141492725|SUPERIORITY|||||||0.1125|||||||t-test, 2 sided|||||||0.1125
70992407|NCT04047121|141492725|SUPERIORITY|||||||0.7156|||||||t-test, 2 sided|||||||0.7156
70992408|NCT04047121|141492725|SUPERIORITY|||||||0.2056|||||||t-test, 2 sided|||||||0.2056
70992409|NCT04047121|141492725|SUPERIORITY||Odds Ratio (OR)|-1.8061||||0.4288|TWO_SIDED|95.0|-6.2797|2.6675|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.6675|-6.2797|0.4288
70992410|NCT04047121|141492725|SUPERIORITY||Odds Ratio (OR)|-1.6946||||0.6303|TWO_SIDED|95.0|-8.5962|5.2069|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||5.2069|-8.5962|0.6303
70992411|NCT04047121|141492725|SUPERIORITY||Odds Ratio (OR)|-0.9873||||0.7477|TWO_SIDED|95.0|-7.0028|5.0281|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||5.0281|-7.0028|0.7477
70992412|NCT04047121|141492726|SUPERIORITY|||||||0.3919|||||||t-test, 2 sided|||||||0.3919
70992413|NCT04047121|141492726|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70992414|NCT04047121|141492726|SUPERIORITY|||||||0.0193|||||||t-test, 2 sided|||||||0.0193
70992415|NCT04047121|141492726|SUPERIORITY||Cost Ratio|1.2232||||0.057|TWO_SIDED|95.0|0.994|1.5053|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a generalized linear model (GLM). Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.5053|0.9940|0.0570
70992416|NCT04047121|141492726|SUPERIORITY||Cost Ratio|1.8479|||<|0.0001|TWO_SIDED|95.0|1.4378|2.3749|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.3749|1.4378|<0.0001
70992417|NCT04047121|141492726|SUPERIORITY||Cost Ratio|1.1868||||0.0924|TWO_SIDED|95.0|0.9722|1.4487|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.4487|0.9722|0.0924
70992418|NCT04047121|141492727|SUPERIORITY|||||||0.6184|||||||t-test, 2 sided|||||||0.6184
70992419|NCT04047121|141492727|SUPERIORITY|||||||0.1952|||||||t-test, 2 sided|||||||0.1952
70992420|NCT04047121|141492727|SUPERIORITY|||||||0.1638|||||||t-test, 2 sided|||||||0.1638
70992421|NCT04047121|141492727|SUPERIORITY||Cost Ratio|0.9773||||0.6732|TWO_SIDED|95.0|0.8782|1.0875|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.0875|0.8782|0.6732
70992422|NCT04047121|141492727|SUPERIORITY||Cost Ratio|0.9629||||0.6345|TWO_SIDED|95.0|0.824|1.1253|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.1253|0.8240|0.6345
70992423|NCT04047121|141492727|SUPERIORITY||Cost Ratio|0.8327||||0.0029|TWO_SIDED|95.0|0.738|0.9395|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.9395|0.7380|0.0029
70992424|NCT04047121|141492728|SUPERIORITY|||||||0.3087|||||||t-test, 2 sided|||||||0.3087
70992425|NCT04047121|141492728|SUPERIORITY|||||||0.0003|||||||t-test, 2 sided|||||||0.0003
70992426|NCT04047121|141492728|SUPERIORITY|||||||0.0647|||||||t-test, 2 sided|||||||0.0647
70992427|NCT04047121|141492728|SUPERIORITY||Cost Ratio|0.9762||||0.7684|TWO_SIDED|95.0|0.8316|1.146|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.1460|0.8316|0.7684
70992428|NCT04047121|141492728|SUPERIORITY||Cost Ratio|1.3862||||0.0012|TWO_SIDED|95.0|1.1379|1.6886|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.6886|1.1379|0.0012
70992429|NCT04047121|141492728|SUPERIORITY||Cost Ratio|1.0065||||0.9422|TWO_SIDED|95.0|0.8452|1.1985|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.1985|0.8452|0.9422
70992430|NCT04047121|141492729|SUPERIORITY|||||||0.0421|||||||t-test, 2 sided|||||||0.0421
70992431|NCT04047121|141492729|SUPERIORITY|||||||0.8137|||||||t-test, 2 sided|||||||0.8137
70992432|NCT04047121|141492729|SUPERIORITY|||||||0.9416|||||||t-test, 2 sided|||||||0.9416
70992433|NCT04047121|141492729|SUPERIORITY||Cost Ratio|0.9515||||0.319|TWO_SIDED|95.0|0.8628|1.0493|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.0493|0.8628|0.3190
70992434|NCT04047121|141492729|SUPERIORITY||Cost Ratio|0.8991||||0.1368|TWO_SIDED|95.0|0.7815|1.0343|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.0343|0.7815|0.1368
70992435|NCT04047121|141492729|SUPERIORITY||Cost Ratio|0.8514||||0.0231|TWO_SIDED|95.0|0.7411|0.9782|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.9782|0.7411|0.0231
70992436|NCT02625324|141492730|SUPERIORITY||Event Rate|0.023|||<|0.0001|ONE_SIDED|97.5||0.081|||Exact binomial test|||"The primary study endpoint, major device effect at 30 days, is a dichotomous study outcome; hence, an exact method based on the binomial distribution was used for the hypothesis testing. The primary study endpoint was tested against a performance goal of 16%:~H0: p ≥ 16% vs. Ha: p \<16%, where p denotes the true event rate of primary study endpoint in the target population."||0.081||<0.0001
70992437|NCT00424528|141492742|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Study baseline FEV1 as covariate and treatment group as fixed effect.||||||<0.001
70923277|NCT04970407|141337852|SUPERIORITY||Treatment difference|-1.16||||0.8769|TWO_SIDED|95.0|-16.25|13.93|||MMRM model|||The adjusted mean, standard error (SE) and 95% confidence interval (CI) of the adjusted mean as well as difference in % relative to baseline and p-value were obtained from a MMRM with Fisher scoring with treatment, time (corresponding to all study visits when CMAP was measured), treatment by time interaction and baseline CMAP amplitude as factors and an unstructured variance covariance matrix.||13.93|-16.25|0.8769
70992438|NCT00424528|141492742|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Study Baseline FEV1 as a covariate and treatment group as a fixed effect.||||||<0.001
70992439|NCT00424528|141492742|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Primary analysis:Group 2 vs 3. Key secondary analysis: Group 1 vs 3. Multiple comparisons for the analysis of the primary endpoint were controlled at the 5% level.|ANCOVA|Study baseline FEV1 as a covariate and treatment group as fixed effect.||||||<0.001
70992440|NCT00424528|141492743|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||||||<0.001
70992441|NCT00424528|141492743|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||||||0.001
70992442|NCT00424528|141492744|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||||||0.001
70992443|NCT00424528|141492744|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||||||<0.001
70992444|NCT00424528|141492745|SUPERIORITY_OR_OTHER|||||||0.073||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||||||0.073
70992445|NCT00424528|141492745|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||||||0.050
70992446|NCT00424528|141492748|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||ANCOVA|Week 0 comparisons: Study baseline FEV1 as a covariate and treatment group as a fixed effect.||Week 0 comparisons||||0.060
70992447|NCT00424528|141492748|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||Week 0||||<0.001
70992448|NCT00424528|141492748|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANCOVA|Week 2 comparisons: Study baseline FEV1 as a covariate and treatment group as a fixed effect.||Week 2 comparisons||||0.004
70992449|NCT00424528|141492748|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|Week 2 comparisons: Study baseline FEV1 as a covariate and treatment group as a fixed effect.||Week 2 comparisons||||0.002
71098985|NCT02070380|141706584|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
71098986|NCT02070380|141706584|SUPERIORITY_OR_OTHER|||||||0.5983|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.05 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus postdose paired global assessment."||||0.5983
71098987|NCT02070380|141706585|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect||||||<0.0001
71098988|NCT02070380|141706585|SUPERIORITY_OR_OTHER|||||||0.6898|||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect||||||0.6898
71098989|NCT02070380|141706585|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect.||||||<0.0001
71098990|NCT02070380|141706585|SUPERIORITY_OR_OTHER|||||||0.1156|||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect||||||0.1156
71098991|NCT02070380|141706585|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71098992|NCT02070380|141706585|SUPERIORITY_OR_OTHER|||||||0.7726|||||||Mixed Models Analysis|||||||0.7726
71098993|NCT02070380|141706586|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||0.0002
71098994|NCT02070380|141706586|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||<0.0001
71098995|NCT02070380|141706586|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||<0.0001
71098996|NCT02070380|141706586|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||<0.0001
71098997|NCT02070380|141706586|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||<0.0001
71098998|NCT02070380|141706586|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||0.0003
71039370|NCT00660387|141586986|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|0.07|STANDARD_ERROR_OF_MEAN|0.038||0.067|TWO_SIDED|95.0|-0.005|0.146|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding Baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||0.146|-0.005|0.0670
71039371|NCT00660387|141586987|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-4.5|STANDARD_ERROR_OF_MEAN|3.1||0.1501|TWO_SIDED|95.0|-10.7|1.7|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||1.7|-10.7|0.1501
71039372|NCT00660387|141586988|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-0.08|STANDARD_ERROR_OF_MEAN|0.45||0.8574|TWO_SIDED|95.0|-0.98|0.82|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||0.82|-0.98|0.8574
71039373|NCT00660387|141586989|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-10.4|STANDARD_ERROR_OF_MEAN|4.3||0.0184|TWO_SIDED|95.0|-19.1|-1.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-1.8|-19.1|0.0184
71039374|NCT00660387|141586990|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-11.6|STANDARD_ERROR_OF_MEAN|4.5||0.0129|TWO_SIDED|95.0|-20.6|-2.5|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-2.5|-20.6|0.0129
71039375|NCT00660387|141586991|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-2.2|STANDARD_ERROR_OF_MEAN|3.4||0.5246|TWO_SIDED|95.0|-9.0|4.6|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||4.6|-9.0|0.5246
71039376|NCT00660387|141586992|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-4.5|STANDARD_ERROR_OF_MEAN|3.8||0.2423|TWO_SIDED|95.0|-12.0|3.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||3.1|-12.0|0.2423
71039377|NCT00660387|141586993|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-3.8|STANDARD_ERROR_OF_MEAN|3.1||0.2243|TWO_SIDED|95.0|-9.9|2.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||2.4|-9.9|0.2243
71039378|NCT00660387|141586994|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-4.0|STANDARD_ERROR_OF_MEAN|3.4||0.2407|TWO_SIDED|95.0|-10.8|2.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||2.8|-10.8|0.2407
71039379|NCT00660387|141586995|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-13.8|STANDARD_ERROR_OF_MEAN|3.5||0.0002|TWO_SIDED|95.0|-20.8|-6.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-6.8|-20.8|0.0002
71039380|NCT00660387|141586996|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-3.3|STANDARD_ERROR_OF_MEAN|5.1||0.5213|TWO_SIDED|95.0|-13.6|6.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||6.9|-13.6|0.5213
71039381|NCT00660387|141586997|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3741|TWO_SIDED|95.0|-0.4|0.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||0.9|-0.4|0.3741
71039382|NCT00660387|141586998|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-1.2|STANDARD_ERROR_OF_MEAN|0.6||0.0361|TWO_SIDED|95.0|-2.4|-0.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-0.1|-2.4|0.0361
71039383|NCT00660387|141586999|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-0.4|STANDARD_ERROR_OF_MEAN|0.4||0.3578|TWO_SIDED|95.0|-1.1|0.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||0.4|-1.1|0.3578
71039384|NCT00660387|141587000|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-1.5|STANDARD_ERROR_OF_MEAN|2.9||0.6088|TWO_SIDED|95.0|-7.4|4.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||4.4|-7.4|0.6088
71039385|NCT00660387|141587001|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|11.4|STANDARD_ERROR_OF_MEAN|3.7||0.0033|TWO_SIDED|95.0|4.0|18.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||18.9|4.0|0.0033
71039386|NCT01251393|141587004|EQUIVALENCE|"The comparisons between the placebo and the biperiden groups at baseline were performed by means of the independent t-Test. We evaluated the normality (Kolmogorov's test) and homogeneity (Levene's test) of the sample.~We used an ANOVA for repeated measures, followed by Bonferroni's post-hoc test to evaluate the efficacy of biperiden in reducing consumption of cocaine/crack."|||||<|0.05||||||We used an ANOVA for repeated measures, followed by Bonferroni's post-hoc test to evaluate the efficacy of biperiden in reducing consumption of cocaine/crack.|ANOVA|||We evaluated the normality (Kolmogorov's test) and homogeneity (Levene's test) of the sample.||||<0.05
71039387|NCT04729101|141587005|OTHER|Additional statistics were descriptive in nature.|Least-squares mean difference|38.98|||||TWO_SIDED|95.0|31.94|46.02||||||Vonoprazan versus lansoprazole on Day 1 of each treatment period.||46.02|31.94|
71039388|NCT04729101|141587005|OTHER|Additional statistics were descriptive in nature|Least-squares mean difference|44.62|||||TWO_SIDED|95.0|37.55|51.69||||||Vonoprazan versus lansoprazole on Day 7 of each treatment period.||51.69|37.55|
71039389|NCT04729101|141587006|OTHER|Additional statistics were descriptive in nature.|Least-squares mean difference|1.72|||||TWO_SIDED|95.0|1.4|2.04||||||Vonoprazan versus lansoprazole on Day 1 of each treatment period.||2.04|1.40|
71039390|NCT04729101|141587006|OTHER|Additional statistics were descriptive in nature.|Least-squares mean difference|2.09|||||TWO_SIDED|95.0|1.74|2.44||||||Vonoprazan versus lansoprazole on Day 7 of each treatment period.||2.44|1.74|
71039391|NCT03086135|141587014|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||PTA4 at 3 months with the Osia system vs Unaided at visit 1||||<0.0001
71039392|NCT03086135|141587015|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in noise at 3 months with the Osia system vs Unaided at visit 1||||<0.0001
71039393|NCT03086135|141587016|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||PTA4 at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
71039394|NCT03086135|141587016|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||PTA4 at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039395|NCT03086135|141587016|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||PTA4 at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039396|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry 250Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
71039397|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 500Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
71039398|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 750Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
71039399|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1000Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
71039400|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1500Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
71039401|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 2000Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
71039402|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 3000Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
71039403|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 4000Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
71039404|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 6000Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
71039405|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 8000Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
71039406|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 250Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039407|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 500Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039408|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 750Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039409|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1000Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039410|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1500Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039411|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 2000Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039412|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 3000Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039413|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 4000Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039414|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 6000Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039415|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 8000Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039416|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 250Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039417|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 500Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039418|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 750Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039419|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1000Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039420|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1500Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039421|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 2000Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039422|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 3000Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039423|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 4000Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039424|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 6000Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039425|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 8000Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039426|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 250Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039427|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 500Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039428|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 750Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039429|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1000Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71098999|NCT01507103|141706587|SUPERIORITY_OR_OTHER||Effect estimate|-0.04||||0.794|TWO_SIDED|95.0|-0.72|0.65||Arm effect|type III SS F-test|||Category: CD8+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm C) based on an analysis of covariance (ANCOVA) model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B||0.65|-0.72|0.794
71039430|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1500Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039431|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 2000Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039432|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 3000Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039433|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 4000Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039434|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 6000Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039435|NCT03086135|141587017|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 8000Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039436|NCT03086135|141587018|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
71039437|NCT03086135|141587018|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
71039438|NCT03086135|141587018|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
71039439|NCT03086135|141587018|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039440|NCT03086135|141587018|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039441|NCT03086135|141587018|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039442|NCT03086135|141587018|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039443|NCT03086135|141587018|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039444|NCT03086135|141587018|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039445|NCT03086135|141587018|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039446|NCT03086135|141587018|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Speech in quiet at 65dB at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039447|NCT03086135|141587018|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039448|NCT03086135|141587019|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive speech recognition in noise at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
70992450|NCT00424528|141492751|SUPERIORITY_OR_OTHER|||||||0.206||95.0|||||ANCOVA|Study baseline Inspiratory Capacity as a covariate and treatment group as a fixed effect.||||||0.206
70992451|NCT00424528|141492751|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||ANCOVA|Study baseline Inspiratory Capacity as a covariate and treatment group as a fixed effect.||||||0.025
70992452|NCT03736629|141492762|SUPERIORITY||Mean Difference (Net)|-0.67|STANDARD_ERROR_OF_MEAN|1.72||0.72|TWO_SIDED|95.0|-6.14|4.81|||t-test, 2 sided|||Study did not reach its accrual goal. Sample size is too small to draw any conclusions.||4.81|-6.14|0.72
70992453|NCT03736629|141492763|SUPERIORITY||Mean Difference (Net)|-5.67||||0.59|TWO_SIDED|95.0|-35.98|24.65|||t-test, 2 sided||Study did not reach its accrual goal. Sample size is too small to draw any conclusions.|||24.65|-35.98|0.59
70992454|NCT03736629|141492766|SUPERIORITY|||||||1|||||||Fisher Exact|||Study did not reach its accrual goal. Sample size is too small to draw any conclusions.||||1.0
70992455|NCT00967226|141492770|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|STANDARD_DEVIATION|0.05||0.77|||||||t-test, 2 sided|||intention to treat analysis||||0.77
70992456|NCT02702518|141492793|OTHER||||||<|0.001||||||p-values were calculated via linear quantile mixed model for continuous variables with missing data.|Mixed Models Analysis|||For the outcome measure corneal staining, data at week 8 was compared with data at baseline to determine if a change was significant (threshold p \< 0.05).||||<0.001
70992457|NCT02702518|141492793|OTHER|||||||0.2324||||||p-values were calculated via linear quantile mixed model for continuous variables with missing data.|Mixed Models Analysis|||For the outcome measure corneal staining data at week 8 was compared with data at baseline to determine significant change.||||0.2324
70992458|NCT02702518|141492794|OTHER|||||||0.001||||||p-values were calculated via linear quantile mixed model for continuous variables.|Mixed Models Analysis|||For the outcome measure OSDI, data at week 8 was compared with data at baseline to determine if a change was significant (threshold p \< 0.05).||||0.001
70992459|NCT02702518|141492794|OTHER|||||||0.2257||||||p-values were calculated via linear quantile mixed model for continuous variables.|Mixed Models Analysis|||For the outcome measure OSDI data at week 8 was compared with data at baseline to determine significant change.||||0.2257
70992460|NCT01042613|141492795|SUPERIORITY_OR_OTHER||Difference of the Binomial Proportions|0.02||||0.851||95.0|||||Fisher Exact|||||||.851
70992461|NCT01042613|141492796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.105||95.0|||||Wilcoxon (Mann-Whitney)|||||||.105
70992462|NCT01042613|141492797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.8||95.0|||||Wilcoxon (Mann-Whitney)|||||||.8
70992463|NCT00165841|141492798|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value was adjusted for multiple comparisons.|t-test, 2 sided|The primary analysis was on the ITT population using all observed data collected from Day 1 of the maintenance phase until the endpoint.||Efficacy analyses were based on the intent-to-treat (ITT) population, which was comprised of all patients in the safety-evaluable population who had a baseline and ≥1 post-randomization primary efficacy endpoint evaluation and who had received ≥1 dose of study medication during the maintenance phase.||||<0.0001
70992464|NCT00487084|141492801|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Log Rank|||A sample of 56 was estimated to have an 80% power to detect a 30% difference in the proportion of subjects with continuing analgesia in the MCS versus the SCM groups when 50% of the subjects in the SCM had requested supplemental analgesia. 28 subjects was added to compare the influence of time of morphine and 2-chloroprocaine administration to lidocaine-morphine analgesia. The primary outcome was compared using Kaplan-Meier survival analysis and the log-rank test.||||0.006
71099000|NCT01507103|141706587|SUPERIORITY_OR_OTHER||Effect estimate|-0.2||||0.794|TWO_SIDED|95.0|-0.82|0.43||Arm effect|type III SS F-test|||Category: CD8+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm B vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B||0.43|-0.82|0.794
70992465|NCT00487084|141492801|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||Log Rank|||||||0.83
70992466|NCT00487084|141492801|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Log Rank|||||||0.009
70992467|NCT00487084|141492802|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Kruskal-Wallis|||||||<0.05
71099001|NCT01507103|141706587|SUPERIORITY_OR_OTHER||Effect estimate|0.16||||0.794|TWO_SIDED|95.0|-0.49|0.82||Arm effect|type III SS F-test|||Category: CD8+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm B) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B||0.82|-0.49|0.794
70992468|NCT00487084|141492802|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Kruskal-Wallis|||||||<0.05
70992469|NCT00487084|141492803|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Chi-squared, Corrected|||||||0.01
70992470|NCT00487084|141492803|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Chi-squared, Corrected|||||||0.01
70992471|NCT00487084|141492804|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Chi-squared, Corrected|||||||0.20
70992472|NCT02568345|141492821|SUPERIORITY_OR_OTHER||isotonic regression functions through PA|2.2|||||TWO_SIDED|||||The isotonic regression functions through PAVA algorithm were used (pooled adjacent violators algorithm), to determine the ED90, and bootstrapping to calculate the respective 95% confidence interval with the statistical program R||||||||
70992473|NCT00960934|141492840|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.56||||0.749|TWO_SIDED|95.0|-1.04|2.16||The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.16|-1.04|0.749
70992474|NCT00960934|141492840|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|1.12||||0.333|TWO_SIDED|95.0|-0.6|2.83||The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.83|-0.60|0.333
70923278|NCT04970407|141337852|SUPERIORITY||Treatment difference|-10.61||||0.162|TWO_SIDED|95.0|-25.69|4.47|||MMRM model|||The adjusted mean, SE and 95% CI of the adjusted mean as well as difference in % relative to baseline and p-value were obtained from a MMRM with Fisher scoring with treatment, time (corresponding to all study visits when CMAP was measured), treatment by time interaction and baseline CMAP amplitude as factors and an unstructured variance covariance matrix.||4.47|-25.69|0.1620
70923279|NCT04761302|141337878|SUPERIORITY|||||||0.215||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.215
70923280|NCT04761302|141337878|SUPERIORITY|||||||0.445||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.445
70923281|NCT04761302|141337879|SUPERIORITY|||||||0.041||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.041
70923282|NCT04761302|141337879|SUPERIORITY|||||||0.3||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.300
70923283|NCT04761302|141337880|SUPERIORITY|||||||0.12||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.12
70923284|NCT04761302|141337880|SUPERIORITY|||||||0.359||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.359
70923285|NCT04761302|141337881|SUPERIORITY|||||||0.083||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.083
70923286|NCT04761302|141337881|SUPERIORITY|||||||0.152||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.152
70992475|NCT00960934|141492840|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.35||||0.823|TWO_SIDED|95.0|-1.14|1.84||The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.84|-1.14|0.823
70992476|NCT00960934|141492840|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.93||||0.457|TWO_SIDED|95.0|-0.75|2.61||The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.61|-0.75|0.457
70992477|NCT00960934|141492840|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.16||||0.823|TWO_SIDED|95.0|-1.17|1.5||The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.50|-1.17|0.823
70992478|NCT00960934|141492841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|69.8|||<|0.001||95.0|56.5|80.0|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||80.0|56.5|<0.001
70992479|NCT00960934|141492841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.1|||<|0.001|TWO_SIDED|95.0|39.6|65.2|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||65.2|39.6|<0.001
70923287|NCT04761302|141337882|SUPERIORITY|||||||0.002||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.002
70923288|NCT04761302|141337882|SUPERIORITY||||||<|0.001||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||<0.001
70923289|NCT04761302|141337883|SUPERIORITY|||||||0.002||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.002
70923290|NCT04761302|141337883|SUPERIORITY||||||<|0.001||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||<0.001
70923291|NCT04761302|141337884|SUPERIORITY|||||||0.004||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.004
70923292|NCT04761302|141337884|SUPERIORITY||||||<|0.001||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||<0.001
70923293|NCT04761302|141337885|SUPERIORITY|||||||0.006||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.006
70923294|NCT04761302|141337885|SUPERIORITY||||||<|0.001||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||<0.001
70923295|NCT04761302|141337886|SUPERIORITY|||||||0.354||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.354
70923296|NCT04761302|141337886|SUPERIORITY|||||||0.455||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.455
70923297|NCT04052516|141337887|OTHER|Cochran-Mantel-Haenszal test|Odds Ratio (OR)|1.7||||0.2991|TWO_SIDED|95.0|0.62|4.63|||Cochran-Mantel-Haenszel|||||4.63|0.62|0.2991
70923298|NCT04052516|141337887|OTHER|Cochran-Mantel-Haenszel Test|Odds Ratio (OR)|2.01||||0.1386|TWO_SIDED|95.0|0.8|5.08|||Cochran-Mantel-Haenszel|||||5.08|0.80|0.1386
70923299|NCT04505774|141337932|SUPERIORITY|||||||0.6778|||||||t-test, 2 sided|||||||.6778
70923300|NCT04505774|141337932|SUPERIORITY|||||||0.6292|||||||t-test, 2 sided|||||||.6292
70923301|NCT04505774|141337932|SUPERIORITY|||||||0.6858|||||||t-test, 2 sided|||||||.6858
70923302|NCT04505774|141337932|SUPERIORITY|||||||0.1351|||||||t-test, 2 sided|||||||.1351
70923303|NCT04505774|141337933|SUPERIORITY|||||||0.1959|||||||Chi-squared|||||||.1959
70923304|NCT04505774|141337933|SUPERIORITY|||||||0.9496|||||||Chi-squared|||||||0.9496
70923305|NCT04505774|141337933|SUPERIORITY|||||||0.9902|||||||Chi-squared|||||||.9902
70923306|NCT04505774|141337933|SUPERIORITY|||||||0.0814|||||||Chi-squared|||||||.0814
70923307|NCT04505774|141337934|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
70923308|NCT04505774|141337934|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
70923309|NCT04505774|141337934|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
70923310|NCT04505774|141337935|SUPERIORITY|||||||0.0577|||||||Chi-squared|||||||.0577
70923311|NCT04505774|141337935|SUPERIORITY|||||||0.5015|||||||Chi-squared|||||||.5015
70923312|NCT04505774|141337935|SUPERIORITY|||||||0.5892|||||||Chi-squared|||||||.5892
70923313|NCT04505774|141337935|SUPERIORITY|||||||0.1714|||||||Chi-squared|||||||.1714
70923314|NCT04505774|141337936|SUPERIORITY|||||||0.0732|||||||Chi-squared|||||||.0732
70923315|NCT04505774|141337936|SUPERIORITY|||||||0.9018|||||||Chi-squared|||||||.9018
70923316|NCT04505774|141337936|SUPERIORITY|||||||0.5075|||||||Chi-squared|||||||.5075
70923317|NCT04505774|141337936|SUPERIORITY|||||||0.145|||||||Chi-squared|||||||.1450
70923318|NCT04505774|141337937|SUPERIORITY|||||||0.8837|||||||Chi-squared|||||||.8837
70992480|NCT00960934|141492841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.6|||<|0.001|TWO_SIDED|95.0|17.6|42.4|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||42.4|17.6|<0.001
70923319|NCT04505774|141337937|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
70923320|NCT04505774|141337937|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
70992481|NCT00960934|141492841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.1|||<|0.001|TWO_SIDED|95.0|17.0|42.0|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||42.0|17.0|<0.001
70923321|NCT04505774|141337937|SUPERIORITY|||||||0.5343|||||||Chi-squared|||||||.5343
70992482|NCT00960934|141492841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6||||0.254|TWO_SIDED|95.0|-4.1|14.4|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||14.4|-4.1|0.254
70992483|NCT00960934|141492842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.6|||<|0.001|TWO_SIDED|95.0|34.9|60.0|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||60.0|34.9|<0.001
70992484|NCT00960934|141492842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.9|||<|0.001|TWO_SIDED|95.0|24.1|48.5|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||48.5|24.1|<0.001
70992485|NCT00960934|141492842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.2||||0.001|TWO_SIDED|95.0|7.7|28.7|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||28.7|7.7|0.001
70992486|NCT00960934|141492842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.1||||0.05|TWO_SIDED|95.0|0.0|18.2|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||18.2|-0.0|0.050
70992487|NCT00960934|141492842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.313|TWO_SIDED|95.0|-8.5|4.2|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||4.2|-8.5|0.313
71039449|NCT03086135|141587019|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive speech recognition in noise at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039450|NCT03086135|141587019|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive speech recognition in noise at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039451|NCT03086135|141587020|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Ease of communication, at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039452|NCT03086135|141587020|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Background noise, at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039453|NCT03086135|141587020|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Reverberation, at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039454|NCT03086135|141587020|SUPERIORITY|||||||0.51|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Aversiveness, at 3 months with the Osia system vs Unaided at visit 1.||||0.51
71039455|NCT03086135|141587020|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Global score, at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039456|NCT03086135|141587020|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Ease of communication, at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039457|NCT03086135|141587020|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Background noise, at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
70992488|NCT00960934|141492843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||>|0.999|TWO_SIDED|95.0|-5.8|5.8|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||5.8|-5.8|>0.999
70992489|NCT00960934|141492843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||>|0.999|TWO_SIDED|95.0|-5.8|5.7|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||5.7|-5.8|>0.999
71039458|NCT03086135|141587020|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Reverberation, at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039459|NCT03086135|141587020|SUPERIORITY|||||||0.32|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Aversiveness, at 12 months with the Osia system vs Unaided at visit 1.||||0.32
71039460|NCT03086135|141587020|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Global score, at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039461|NCT03086135|141587021|SUPERIORITY|||||||0.026|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Comprehensive health state at 3 months with the Osia system vs Unaided at visit 1.||||0.026
71039462|NCT03086135|141587021|SUPERIORITY|||||||0.5|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Vision attribute at 3 months with the Osia system vs Unaided at visit 1.||||0.50
71099002|NCT01507103|141706587|SUPERIORITY_OR_OTHER||Effect estimate|0.02||||0.654|TWO_SIDED|95.0|-0.52|0.57||Arm effect|type III SS F-test|||Category: CD8+/GrB+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B||0.57|-0.52|0.654
71099003|NCT01507103|141706587|SUPERIORITY_OR_OTHER||Effect estimate|-0.19||||0.654|TWO_SIDED|95.0|-0.69|0.31||Arm effect|type III SS F-test|||Category: CD8+/GrB+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm B vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B||0.31|-0.69|0.654
71099004|NCT01507103|141706587|SUPERIORITY_OR_OTHER||Effect estimate|0.21||||0.654|TWO_SIDED|95.0|-0.31|0.74||Arm effect|type III SS F-test|||Category: CD8+/GrB+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm B) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B||0.74|-0.31|0.654
71099005|NCT01507103|141706588|SUPERIORITY_OR_OTHER||LS Means estimate|-0.03||||0.921|TWO_SIDED|95.0|-0.73|0.67|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category: CD8+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.||0.67|-0.73|0.921
71099006|NCT01507103|141706588|SUPERIORITY_OR_OTHER||LS Means estimate|-0.2||||0.921|TWO_SIDED|95.0|-0.83|0.44|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category: CD8+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm B vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.||0.44|-0.83|0.921
71039463|NCT03086135|141587021|SUPERIORITY|||||||0.0008|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Hearing attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.0008
71039464|NCT03086135|141587021|SUPERIORITY|||||||0.082|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Speech attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.082
71039465|NCT03086135|141587021|SUPERIORITY|||||||0.13|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Ambulation attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.13
71039466|NCT03086135|141587021|SUPERIORITY|||||||0.9|TWO_SIDED|95.0|||||Wilcoxon Signed Rank test|||HUI Dexterity attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.9
71039467|NCT03086135|141587021|SUPERIORITY|||||||0.43|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Emotion attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.43
71039468|NCT03086135|141587021|SUPERIORITY|||||||0.31|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Cognition attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.31
71039469|NCT03086135|141587021|SUPERIORITY|||||||0.72|TWO_SIDED|95.0|||||Wilcoxon Signed Rank test|||HUI Pain attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.72
71039470|NCT03086135|141587021|SUPERIORITY|||||||0.13|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Comprehensive Health State attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.13
71099007|NCT01507103|141706588|SUPERIORITY_OR_OTHER||LS Means estimate|0.17||||0.921|TWO_SIDED|95.0|-0.5|0.83|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category: CD8+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm B) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.||0.83|-0.50|0.921
71039471|NCT03086135|141587021|SUPERIORITY|||||||0.23|TWO_SIDED|95.0|||||Wilcoxon Signed Rank test|||HUI Vision attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.23
71039472|NCT03086135|141587021|SUPERIORITY|||||||0.0026|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Hearing attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.0026
71039473|NCT03086135|141587021|SUPERIORITY|||||||0.0024|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Speech attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.0024
71039474|NCT03086135|141587021|SUPERIORITY|||||||0.16|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Ambulation attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.16
71039475|NCT03086135|141587021|SUPERIORITY|||||||0.16|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Dexterity attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.16
71039476|NCT03086135|141587021|SUPERIORITY|||||||0.85|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Emotion attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.85
71099008|NCT01507103|141706588|SUPERIORITY_OR_OTHER||LS Means estimate|0.02||||0.89|TWO_SIDED|95.0|-0.54|0.58|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category:CD8+/GrB+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm C) based on an ANCOVA model. Difference from baseline=Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.||0.58|-0.54|0.890
70923322|NCT04505774|141337938|SUPERIORITY|||||||0.6636|||||||t-test, 2 sided|||||||.6636
71039477|NCT03086135|141587021|SUPERIORITY|||||||1|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Cognition attribute, at 12 months with the Osia system vs Unaided at visit 1.||||1.0
71039478|NCT03086135|141587021|SUPERIORITY|||||||0.56|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Pain attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.56
71039479|NCT03086135|141587022|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Total score at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039480|NCT03086135|141587022|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Speech score at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039481|NCT03086135|141587022|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Spatial score at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039482|NCT03086135|141587022|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Quality score at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039483|NCT03086135|141587022|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Total score at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039484|NCT03086135|141587022|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Speech score at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039485|NCT03086135|141587022|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Spatial score at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039486|NCT03086135|141587022|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Quality score at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71039487|NCT03086135|141587023|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry PTA4 with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||<0.0001
71039488|NCT03086135|141587023|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry PTA4 with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71039489|NCT03086135|141587023|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry PTA4 with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71039490|NCT03086135|141587023|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry PTA4 with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71099009|NCT01507103|141706588|SUPERIORITY_OR_OTHER||LS Means estimate|-0.19||||0.89|TWO_SIDED|95.0|-0.7|0.31|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category:CD8+/GrB+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm B vs Arm C) based on an ANCOVA model. Difference from baseline=Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.||0.31|-0.70|0.890
71039491|NCT03086135|141587024|SUPERIORITY|||||||0.025|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 250Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.025
70992490|NCT00960934|141492843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||>|0.999|TWO_SIDED|95.0|-5.8|5.7|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||5.7|-5.8|>0.999
70992491|NCT00960934|141492843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.313|TWO_SIDED|95.0|-4.2|8.6|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||8.6|-4.2|0.313
70992492|NCT00960934|141492843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.321|TWO_SIDED|95.0|-4.3|8.4|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||8.4|-4.3|0.321
70992493|NCT00960934|141492845|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.24||||0.959|TWO_SIDED|95.0|-1.03|1.51||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.51|-1.03|0.959
70992494|NCT00960934|141492845|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.02||||0.971|TWO_SIDED|95.0|-1.08|1.04||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.04|-1.08|0.971
70992495|NCT00960934|141492845|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.24||||0.959|TWO_SIDED|95.0|-0.95|1.42||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.42|-0.95|0.959
70992496|NCT00960934|141492845|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.41||||0.915|TWO_SIDED|95.0|-1.78|0.97||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.97|-1.78|0.915
70992497|NCT00960934|141492845|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.28||||0.959|TWO_SIDED|95.0|-1.6|1.04||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.04|-1.60|0.959
70992498|NCT00960934|141492846|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.58||||0.849|TWO_SIDED|95.0|-1.22|2.37||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.37|-1.22|0.849
70992499|NCT00960934|141492846|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.16||||0.964|TWO_SIDED|95.0|-1.79|1.47||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.47|-1.79|0.964
70992500|NCT00960934|141492846|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.16||||0.964|TWO_SIDED|95.0|-1.27|1.59||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.59|-1.27|0.964
70992501|NCT00960934|141492846|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.48||||0.855|TWO_SIDED|95.0|-2.23|1.27||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.27|-2.23|0.855
70992502|NCT00960934|141492846|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|1.27||||0.287|TWO_SIDED|95.0|-0.58|3.12||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||3.12|-0.58|0.287
70992503|NCT00960934|141492847|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.6||||0.933|TWO_SIDED|95.0|-1.56|2.77||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.77|-1.56|0.933
70992504|NCT00960934|141492847|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.01||||0.999|TWO_SIDED|95.0|-1.69|1.68||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.68|-1.69|0.999
70992505|NCT00960934|141492847|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.05||||0.999|TWO_SIDED|95.0|-1.84|1.93||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.93|-1.84|0.999
70992506|NCT00960934|141492847|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.45||||0.959|TWO_SIDED|95.0|-1.67|2.57||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.57|-1.67|0.959
70992507|NCT00960934|141492847|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.08||||0.999|TWO_SIDED|95.0|-2.1|1.94||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.94|-2.10|0.999
70923323|NCT04505774|141337938|SUPERIORITY|||||||0.5878|||||||t-test, 2 sided|||||||.5878
70923324|NCT04505774|141337938|SUPERIORITY|||||||0.7148|||||||t-test, 2 sided|||||||.7148
70923325|NCT04505774|141337938|SUPERIORITY|||||||0.1117|||||||t-test, 2 sided|||||||.1117
70992508|NCT00960934|141492848|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.17||||0.976|TWO_SIDED|95.0|-1.12|0.77||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.77|-1.12|0.976
70992509|NCT00960934|141492848|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.06||||0.982|TWO_SIDED|95.0|-0.93|0.8||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.80|-0.93|0.982
71039492|NCT03086135|141587024|SUPERIORITY|||||||0.096|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 500Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.096
71039493|NCT03086135|141587024|SUPERIORITY|||||||0.015|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 750Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.015
71039494|NCT03086135|141587024|SUPERIORITY|||||||0.67|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.67
71039495|NCT03086135|141587024|SUPERIORITY|||||||0.73|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1500Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.73
71039496|NCT03086135|141587024|SUPERIORITY|||||||0.019|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 2000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.019
71039497|NCT03086135|141587024|SUPERIORITY|||||||0.0046|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 3000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.0046
71039498|NCT03086135|141587024|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 4000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||<0.0001
71039499|NCT03086135|141587024|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 6000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||<0.0001
71039500|NCT03086135|141587024|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 8000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||<0.0001
71039501|NCT03086135|141587024|SUPERIORITY|||||||0.019|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 250Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.019
70923326|NCT04505774|141337939|SUPERIORITY|||||||0.678|||||||t-test, 2 sided|||||||.6780
70923327|NCT04505774|141337939|SUPERIORITY|||||||0.6638|||||||t-test, 2 sided|||||||.6638
70923328|NCT04505774|141337939|SUPERIORITY|||||||0.7645|||||||t-test, 2 sided|||||||.7645
70923329|NCT04505774|141337939|SUPERIORITY|||||||0.0987|||||||t-test, 2 sided|||||||0.0987
70923330|NCT04505774|141337940|SUPERIORITY|||||||0.4016|||||||t-test, 2 sided|||||||.4016
70923331|NCT04505774|141337940|SUPERIORITY|||||||0.5815|||||||t-test, 2 sided|||||||.5815
71039502|NCT03086135|141587024|SUPERIORITY|||||||0.04|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 500Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.040
71039503|NCT03086135|141587024|SUPERIORITY|||||||0.037|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 750Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.037
71039504|NCT03086135|141587024|SUPERIORITY|||||||0.67|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.67
71039505|NCT03086135|141587024|SUPERIORITY|||||||0.34|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1500Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.34
71039506|NCT03086135|141587024|SUPERIORITY|||||||0.0048|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 2000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.0048
71039507|NCT03086135|141587024|SUPERIORITY|||||||0.0008|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 3000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.0008
71039508|NCT03086135|141587024|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 4000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71039509|NCT03086135|141587024|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Hearing performance: threshold audiometry 6000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71039510|NCT03086135|141587024|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 8000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71039511|NCT03086135|141587024|SUPERIORITY|||||||0.1|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 250Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||0.10
71039512|NCT03086135|141587024|SUPERIORITY|||||||0.0007|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 500Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||0.0007
71039513|NCT03086135|141587024|SUPERIORITY|||||||0.0003|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 750Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||0.0003
71039514|NCT03086135|141587024|SUPERIORITY|||||||0.11|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||0.11
70992510|NCT00960934|141492848|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.53||||0.489|TWO_SIDED|95.0|-0.43|1.49||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.49|-0.43|0.489
70992511|NCT00960934|141492848|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.02||||0.982|TWO_SIDED|95.0|-0.75|0.78||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.78|-0.75|0.982
70992512|NCT00960934|141492848|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.16||||0.976|TWO_SIDED|95.0|-0.76|1.08||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.08|-0.76|0.976
70992513|NCT00960934|141492849|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.35||||0.961|TWO_SIDED|95.0|-2.0|1.31||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.31|-2.00|0.961
70992514|NCT00960934|141492849|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.28||||0.961|TWO_SIDED|95.0|-1.9|1.34||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.34|-1.90|0.961
70992515|NCT00960934|141492849|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.66||||0.778|TWO_SIDED|95.0|-1.01|2.33||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.33|-1.01|0.778
70992516|NCT00960934|141492849|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.11||||0.961|TWO_SIDED|95.0|-1.45|1.24||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.24|-1.45|0.961
70992517|NCT00960934|141492849|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.25||||0.961|TWO_SIDED|95.0|-1.77|1.26||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.26|-1.77|0.961
70992518|NCT00960934|141492850|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.43||||0.901|TWO_SIDED|95.0|-2.03|1.17||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.17|-2.03|0.901
71099010|NCT01507103|141706588|SUPERIORITY_OR_OTHER||LS Means estimate|0.21||||0.89|TWO_SIDED|95.0|-0.32|0.74|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category:CD8+/GrB+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm B) based on an ANCOVA model. Difference from baseline=Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.||0.74|-0.32|0.890
70992519|NCT00960934|141492850|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.51||||0.901|TWO_SIDED|95.0|-2.18|1.17||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.17|-2.18|0.901
70923332|NCT04505774|141337940|SUPERIORITY|||||||0.9085|||||||t-test, 2 sided|||||||.9085
70992520|NCT00960934|141492850|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.52||||0.901|TWO_SIDED|95.0|-2.17|1.13||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.13|-2.17|0.901
70992521|NCT00960934|141492850|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.03||||0.997|TWO_SIDED|95.0|-1.29|1.35||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.35|-1.29|0.997
70992522|NCT00960934|141492850|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.04||||0.997|TWO_SIDED|95.0|-1.51|1.43||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.43|-1.51|0.997
70992523|NCT00960934|141492851|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.37||||0.979|TWO_SIDED|95.0|-2.73|1.99||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.99|-2.73|0.979
70992524|NCT00960934|141492851|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|1.92||||0.363|TWO_SIDED|95.0|-1.1|4.95||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||4.95|-1.10|0.363
70992525|NCT00960934|141492851|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.4||||0.979|TWO_SIDED|95.0|-2.18|2.98||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.98|-2.18|0.979
71099011|NCT04535362|141706651|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.63||0.93|TWO_SIDED||||||Mixed Models Analysis|||The fixed effects in the mixed models were infusion rate (2.5 minutes, 5 minutes and 10 minutes (placebo)), cigarette condition (menthol vs. non-menthol), and their interaction. We also controlled for order effects of cigarette condition by including session in the models Subject was a clustering factor and different variance-covariance structures were considered within each condition and subject. The best-fitting structure was selected based on Schwartz's Bayesian Criterion.||||0.93
71039515|NCT03086135|141587024|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1500Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71039516|NCT03086135|141587024|SUPERIORITY|||||||0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 2000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||0.0001
71039517|NCT03086135|141587024|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 3000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71039518|NCT03086135|141587024|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 4000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71039519|NCT03086135|141587024|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 6000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71039520|NCT03086135|141587024|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 8000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71039521|NCT03086135|141587024|SUPERIORITY|||||||0.8|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 250Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||0.80
71099012|NCT04535362|141706652|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.3||0.68|TWO_SIDED||||||Mixed Models Analysis|||The fixed effects in the mixed models were infusion rate (2.5 minutes, 5 minutes and 10 minutes (placebo)), cigarette condition (menthol vs. non-menthol), and their interaction. We also controlled for order effects of cigarette condition by including session in the models Subject was a clustering factor and different variance-covariance structures were considered within each condition and subject. The best-fitting structure was selected based on Schwartz's Bayesian Criterion.||||0.68
71099013|NCT04535362|141706654|SUPERIORITY||Mean Difference (Net)|0.46|STANDARD_ERROR_OF_MEAN|0.51||0.37|TWO_SIDED||||||Mixed Models Analysis|||The fixed effects in the mixed models were infusion rate (2.5 minutes, 5 minutes and 10 minutes (placebo)), cigarette condition (menthol vs. non-menthol), and their interaction. We also controlled for order effects of cigarette condition by including session in the models Subject was a clustering factor and different variance-covariance structures were considered within each condition and subject. The best-fitting structure was selected based on Schwartz's Bayesian Criterion.||||0.37
70923333|NCT04505774|141337940|SUPERIORITY|||||||0.082|||||||t-test, 2 sided|||||||.0820
70923334|NCT04505774|141337941|SUPERIORITY|||||||0.3135|||||||Chi-squared|||||||.3135
71039522|NCT03086135|141587024|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 500Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71039523|NCT03086135|141587024|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 750Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71039524|NCT03086135|141587024|SUPERIORITY|||||||0.001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||0.0010
71039525|NCT03086135|141587024|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1500Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71039526|NCT03086135|141587024|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 2000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71039527|NCT03086135|141587024|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 3000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71039528|NCT03086135|141587024|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 4000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71039529|NCT03086135|141587024|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 6000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71039530|NCT03086135|141587024|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 8000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71039531|NCT03086135|141587025|SUPERIORITY|||||||0.51|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB SPL with Osia at 4 weeks vs reference device BP110 on softband att visit 1.||||0.51
71039532|NCT03086135|141587025|SUPERIORITY|||||||0.021|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB SPL with Osia at 4 weeks vs reference device BP110 on softband att visit 1.||||0.021
71039533|NCT03086135|141587025|SUPERIORITY|||||||0.29|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB SPL with Osia at 4 weeks vs reference device BP110 on softband att visit 1.||||0.29
71039534|NCT03086135|141587025|SUPERIORITY|||||||0.18|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB SPL with Osia at 3 months vs reference device BP110 on softband att visit 1.||||0.18
71039535|NCT03086135|141587025|SUPERIORITY|||||||0.017|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB SPL with Osia at 3 months vs reference device BP110 on softband att visit 1.||||0.017
71039536|NCT03086135|141587025|SUPERIORITY|||||||0.16|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB SPL with Osia at 3 months vs reference device BP110 on softband att visit 1.||||0.16
71039537|NCT03086135|141587025|SUPERIORITY|||||||0.0051|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB SPL with Osia at 6 months vs reference device BP110 on softband att visit 1.||||0.0051
71039538|NCT03086135|141587025|SUPERIORITY|||||||0.021|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB SPL with Osia at 6 months vs reference device BP110 on softband att visit 1.||||0.021
70992526|NCT00960934|141492851|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.49||||0.979|TWO_SIDED|95.0|-3.27|2.3||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.30|-3.27|0.979
70992527|NCT00960934|141492851|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.51||||0.979|TWO_SIDED|95.0|-2.34|3.37||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||3.37|-2.34|0.979
70992528|NCT00960934|141492852|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|19.77||||0.02|TWO_SIDED|95.0|2.26|37.46||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||37.46|2.26|0.020
70992529|NCT00960934|141492852|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|10.08||||0.357|TWO_SIDED|95.0|-6.16|26.41||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||26.41|-6.16|0.357
70992530|NCT00960934|141492852|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-2.83||||0.642|TWO_SIDED|95.0|-14.81|9.14||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||9.14|-14.81|0.642
70992531|NCT00960934|141492852|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|8.44||||0.434|TWO_SIDED|95.0|-7.09|24.04||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||24.04|-7.09|0.434
70992532|NCT00960934|141492852|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|5.72||||0.579||95.0|-8.62|20.1||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||20.10|-8.62|0.579
70992533|NCT00960934|141492853|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|34.26|||<|0.001|TWO_SIDED|95.0|15.27|53.56||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||53.56|15.27|<0.001
70992534|NCT00960934|141492853|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|20.57||||0.014|TWO_SIDED|95.0|3.28|38.02||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||38.02|3.28|0.014
70992535|NCT00960934|141492853|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|9.97||||0.307|TWO_SIDED|95.0|-5.69|25.7||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||25.70|-5.69|0.307
70992536|NCT00960934|141492853|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|9.02||||0.307|TWO_SIDED|95.0|-5.85|23.95||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||23.95|-5.85|0.307
70992537|NCT00960934|141492853|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.5||||0.937|TWO_SIDED|95.0|-12.92|11.92||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||11.92|-12.92|0.937
71039539|NCT03086135|141587025|SUPERIORITY|||||||0.56|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB SPL with Osia at 6 months vs reference device BP110 on softband att visit 1.||||0.56
70923335|NCT04505774|141337941|SUPERIORITY|||||||0.9581|||||||Chi-squared|||||||.9581
71039540|NCT03086135|141587025|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB SPL with Osia at 12 months vs reference device BP110 on softband att visit 1.||||<0.0001
71039541|NCT03086135|141587025|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB SPL with Osia at 12 months vs reference device BP110 on softband att visit 1.||||<0.0001
71039542|NCT03086135|141587025|SUPERIORITY|||||||0.041|TWO_SIDED|95.0|||||Wilcoxon Signed Rank test|||Speech in quiet at 80dB SPL with Osia at 12 months vs reference device BP110 on softband att visit 1.||||0.041
71039543|NCT03086135|141587026|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive Speech Recognition in Noise with Osia at 4 weeks vs reference device BP110 on softband at visit 1.||||<0.0001
70992538|NCT00960934|141492854|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|19.19|||<|0.001|TWO_SIDED|95.0|7.42|31.02||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||31.02|7.42|<0.001
70992539|NCT00960934|141492854|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|23.38|||<|0.001|TWO_SIDED|95.0|11.02|35.82||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||35.82|11.02|<0.001
70992540|NCT00960934|141492854|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|10.45||||0.061|TWO_SIDED|95.0|-0.37|21.3||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||21.30|-0.37|0.061
70992541|NCT00960934|141492854|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|6.31||||0.283|TWO_SIDED|95.0|-3.81|16.45||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||16.45|-3.81|0.283
70992542|NCT00960934|141492854|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|5.46||||0.283|TWO_SIDED|95.0|-3.39|14.31||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||14.31|-3.39|0.283
70992543|NCT00960934|141492855|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|56.77|||<|0.001|TWO_SIDED|95.0|37.62|76.35||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||76.35|37.62|<.001
70992544|NCT00960934|141492855|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|39.66|||<|0.001|TWO_SIDED|95.0|22.44|57.17||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||57.17|22.44|<.001
70992545|NCT00960934|141492855|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|20.68||||0.003|TWO_SIDED|95.0|5.72|35.78||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||35.78|5.72|0.003
70992546|NCT00960934|141492855|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|8.59||||0.265|TWO_SIDED|95.0|-4.81|22.05||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||22.05|-4.81|0.265
70992547|NCT00960934|141492855|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|8.39||||0.265|TWO_SIDED|95.0|-3.4|20.21||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||20.21|-3.40|0.265
71099014|NCT04535362|141706655|SUPERIORITY||Mean Difference (Net)|1.26|STANDARD_ERROR_OF_MEAN|0.98||0.2|TWO_SIDED||||||Mixed Models Analysis|||The fixed effects in the mixed models were infusion rate (2.5 minutes, 5 minutes and 10 minutes (placebo)), cigarette condition (menthol vs. non-menthol), and their interaction. We also controlled for order effects of cigarette condition by including session in the models Subject was a clustering factor and different variance-covariance structures were considered within each condition and subject. The best-fitting structure was selected based on Schwartz's Bayesian Criterion.||||0.20
70992548|NCT00960934|141492856|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|53.05|||<|0.001|TWO_SIDED|95.0|37.83|68.53||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||68.53|37.83|<0.001
70992549|NCT00960934|141492856|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|41.41|||<|0.001|TWO_SIDED|95.0|27.36|55.65||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||55.65|27.36|<0.001
70992550|NCT00960934|141492856|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|24.81|||<|0.001|TWO_SIDED|95.0|12.39|37.33||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||37.33|12.39|<0.001
70992551|NCT00960934|141492856|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|12.87||||0.02|TWO_SIDED|95.0|1.73|24.06||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||24.06|1.73|0.020
70992552|NCT00960934|141492856|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|4.02||||0.397|TWO_SIDED|95.0|-5.31|13.36||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||13.36|-5.31|0.397
70992553|NCT02387372|141492869|OTHER||Geometric least squares mean ratio (GMR)|1.38|||||TWO_SIDED|90.0|1.21|1.56|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.56|1.21|
70992554|NCT02387372|141492869|OTHER||GMR|1.15|||||TWO_SIDED|90.0|1.03|1.29|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.29|1.03|
71099015|NCT01104870|141706764|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED|||||Primary comparisons are between Dose Group 1 \& Dose Group 3 and Dose Group 1 \& Dose Group 2. The study is not powered to test for a difference between Dose Group 2 \& Dose Group 3.|Wilcoxon (Mann-Whitney)|||Peak total pulmonary resistance index (TPRI) is defined as the TPRI value observed during exercise at the highest matching wattage achieved at both Baseline and Week 12. Where peak wattage cannot be matched, the closest higher wattage will be chosen for comparison.||||0.95
70992555|NCT02387372|141492872|OTHER||Geometric least squares mean ratio (GMR)|1.71|||||TWO_SIDED|90.0|1.5|1.96|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.96|1.50|
70992556|NCT02387372|141492872|OTHER||GMR|1.33|||||TWO_SIDED|90.0|1.14|1.55|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.55|1.14|
70992557|NCT02387372|141492874|OTHER||Geometric least squares mean ratio (GMR)|1.61|||||TWO_SIDED|90.0|1.44|1.81|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.81|1.44|
70992558|NCT02387372|141492874|OTHER||GMR|1.24|||||TWO_SIDED|90.0|1.11|1.39|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.39|1.11|
70992559|NCT02387372|141492875|OTHER||Geometric least squares mean ratio (GMR)|1.71|||||TWO_SIDED|90.0|1.51|1.95|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.95|1.51|
70992560|NCT02387372|141492875|OTHER||GMR|1.2|||||TWO_SIDED|90.0|1.09|1.33|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.33|1.09|
70992561|NCT02190747|141492944|OTHER|||||||0.1664|||||||Cochran-Armitage test of trend|||Cochran-Armitage test of trend (one-sided). The Cochran-Armitage test of trend assessed the overall trend of response across the dose groups (from the lowest dose \[or placebo\], to the highest dose).||||0.1664
70992562|NCT02190747|141492945|OTHER|||||||0.2335|||||||Cochran-Armitage test of trend|||Week 6: Cochran-Armitage test of trend (one-sided). The Cochran-Armitage test of trend assessed the overall trend of response across the dose groups (from the lowest dose \[or placebo\], to the highest dose).||||0.2335
70992563|NCT02190747|141492945|OTHER|||||||0.0837|||||||Cochran-Armitage test of trend|||Week 12: Cochran-Armitage test of trend (one-sided). The Cochran-Armitage test of trend assessed the overall trend of response across the dose groups (from the lowest dose \[or placebo\], to the highest dose).||||0.0837
70992564|NCT02190747|141492946|OTHER||Least square (LS) mean|-86.35|STANDARD_ERROR_OF_MEAN|220.57||0.6984|TWO_SIDED||||||Pairwise test|||Week 6: Analysis of area of new HO||||0.6984
70992565|NCT02190747|141492946|OTHER||LS mean|-38.07|STANDARD_ERROR_OF_MEAN|252.192||0.8811|TWO_SIDED||||||Pairwise test|||Week 6: Analysis of area of new HO||||0.8811
70992566|NCT02190747|141492946|OTHER||LS mean|-764.38|STANDARD_ERROR_OF_MEAN|220.57||0.0017|TWO_SIDED||||||Pairwise test|||Week 12: Analysis of area of new HO||||0.0017
70992567|NCT02190747|141492946|OTHER||LS mean|-703.43|STANDARD_ERROR_OF_MEAN|252.192||0.0094|TWO_SIDED||||||Pairwise test|||Week 12: Analysis of area of new HO||||0.0094
70992568|NCT02190747|141492947|OTHER|||||||0.1503|||||||Cochran-Armitage test of trend|||Cochran-Armitage test of trend (one-sided). The Cochran-Armitage test of trend assessed the overall trend of response across the dose groups (from the lowest dose \[or placebo\], to the highest dose).||||0.1503
70992569|NCT03607838|141492968|SUPERIORITY||Mean Difference (Final Values)|-7.5|STANDARD_ERROR_OF_MEAN|3.35||0.0263|TWO_SIDED|95.0|-14.1|-0.9|||Mixed Models Analysis|||||-0.9|-14.1|0.0263
70992570|NCT03607838|141492969|SUPERIORITY||Mean Difference (Final Values)|-6.5|STANDARD_ERROR_OF_MEAN|3.4||0.0558|TWO_SIDED|95.0|-13.2|0.2||To control family-wise error rate for multiple tests of the primary and key secondary endpoints, serial gatekeeping testing algorithm was used.|Mixed Models Analysis|||||0.2|-13.2|0.0558
70992571|NCT03607838|141492970|SUPERIORITY||Mean Difference (Final Values)|-25.8|STANDARD_ERROR_OF_MEAN|15.24||0.092|TWO_SIDED|95.0|-55.7|4.2||To control family-wise error rate for multiple tests of the primary and key secondary endpoints, serial gatekeeping testing algorithm was used.|Mixed Models Analysis|||||4.2|-55.7|0.0920
70992572|NCT03607838|141492971|SUPERIORITY||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|1.95||0.0336|TWO_SIDED|95.0|-8.0|-0.3||To control family-wise error rate for multiple tests of the primary and key secondary endpoints, serial gatekeeping testing algorithm was used.|Mixed Models Analysis|||||-0.3|-8.0|0.0336
70992573|NCT04866303|141492992|OTHER|unadjusted logistic regression model|Odds Ratio (OR)|1.79||||0.04|TWO_SIDED|95.0|1.03|2.8|||Regression, Logistic|||Minimum testing kit completion rate of 70% in the passive study arm, and calculated that 400 total subjects would provide us with 90% power to detect an effect size associated with a rate ratio of 1.20, or an absolute difference of 14% (70% in passive, 84% in active). A futility boundary of 60% was identified by Community Advisory Board members as justification to prematurely halt trial enrollment if, after completing 25% of expected enrollment, successful test completion fell below that rate.||2.80|1.03|0.04
70992574|NCT04866303|141492993|OTHER||Odds Ratio (OR)|1.39||||0.18|TWO_SIDED|95.0|0.86|2.26|||Regression, Logistic|||Minimum testing kit completion rate of 70% in the passive study arm, and calculated that 400 total subjects would provide us with 90% power to detect an effect size associated with a rate ratio of 1.20, or an absolute difference of 14% (70% in passive, 84% in active). A futility boundary of 60% was identified by Community Advisory Board members as justification to prematurely halt trial enrollment if, after completing 25% of expected enrollment, successful test completion fell below that rate||2.26|0.86|0.18
70992575|NCT03025217|141493079|OTHER||Cohen's d|0.33||||0.095|TWO_SIDED||||||t-test, 2 sided|||||||.095
70992576|NCT03025217|141493080|OTHER||Cohen's d|0.75||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||.001
70992577|NCT04069156|141493081|NON_INFERIORITY|The primary end point assessing non-inferiority of placebo was considered met if the lower boundary of the one-sided 97.5% confidence limit of the difference in the composite success rate between treatment arms (placebo minus aspirin) was greater than the non-inferiority margin (-10%) by the Farrington-Manning test at 12-months in the principal analysis population.|Risk Difference (RD)|6.0|||<|0.0001|ONE_SIDED|97.5|-1.6||||Farrington-Manning risk difference||||||-1.6|<0.0001
70992578|NCT00194025|141493114|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||<0.001
70992579|NCT00194025|141493115|SUPERIORITY_OR_OTHER|||||||0.585||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||0.585
70992580|NCT00194025|141493116|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||<0.001
70992581|NCT00194025|141493117|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||0.017
70992582|NCT00194025|141493118|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||0.027
71099016|NCT01104870|141706764|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED|||||Primary comparisons are between Dose Group 1 \& Dose Group 3 and Dose Group 1 \& Dose Group 2. The study is not powered to test for a difference between Dose Group 2 \& Dose Group 3.|Wilcoxon (Mann-Whitney)|||Peak total pulmonary resistance index (TPRI) is defined as the TPRI value observed during exercise at the highest matching wattage achieved at both Baseline and Week 12. Where peak wattage cannot be matched, the closest higher wattage will be chosen for comparison.||||0.27
70992583|NCT00194025|141493119|SUPERIORITY_OR_OTHER|||||||0.569||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||0.569
70992584|NCT00194025|141493120|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||0.038
70992585|NCT00194025|141493121|SUPERIORITY_OR_OTHER|||||||0.199||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||0.199
70992586|NCT00194025|141493122|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||t-test, 2 sided|||The t-test was applied to the values at baseline vs. the values at 12 weeks.||||0.21
70992587|NCT04804033|141493126|OTHER||Difference in least square mean (LSM)|-1.4|||||TWO_SIDED|97.5|-2.72|-0.12|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||-0.12|-2.72|
70992588|NCT04804033|141493126|OTHER||Difference in LSM|-0.7|||||TWO_SIDED|97.5|-2.07|0.69|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||0.69|-2.07|
70992589|NCT04804033|141493127|OTHER||Difference in percentage|16.6|||||TWO_SIDED|97.5|4.4|28.8|||||Stratified by randomization stratum using Mantel-Haenszel risk estimation.|||28.8|4.4|
70992590|NCT04804033|141493127|OTHER||Difference in percentage|6.6|||||TWO_SIDED|97.5|-5.6|18.9|||||Stratified by randomization stratum using Mantel-Haenszel risk estimation.|||18.9|-5.6|
70992591|NCT04804033|141493128|OTHER||Difference in LSM|-1.0|||||TWO_SIDED|97.5|-2.68|0.58|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||0.58|-2.68|
70992592|NCT04804033|141493128|OTHER||Difference in LSM|-0.4|||||TWO_SIDED|97.5|-2.1|1.31|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||1.31|-2.10|
70992593|NCT04804033|141493129|OTHER||Difference in LSM|-1.8|||||TWO_SIDED|97.5|-3.16|-0.42|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||-0.42|-3.16|
70992594|NCT04804033|141493129|OTHER||Difference in LSM|-1.2|||||TWO_SIDED|97.5|-2.53|0.22|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||0.22|-2.53|
70992595|NCT04804033|141493130|OTHER||Difference in LSM|-0.8|||||TWO_SIDED|97.5|-1.59|0.05|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||0.05|-1.59|
70992596|NCT04804033|141493130|OTHER||Difference in LSM|-0.2|||||TWO_SIDED|97.5|-1.06|0.74|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||0.74|-1.06|
70992597|NCT04804033|141493131|OTHER||Difference in LSM|3.9|||||TWO_SIDED|97.5|-1.5|9.39|||||Linear regression model had the following variables: Week 12 change from baseline in domain score as the dependent variable; baseline domain score as a covariate; treatment group and randomization stratum as fixed effects.|||9.39|-1.50|
70992598|NCT04804033|141493131|OTHER||Difference in LSM|0.1|||||TWO_SIDED|97.5|-5.66|5.86|||||Linear regression model had the following variables: Week 12 change from baseline in domain score as the dependent variable; baseline domain score as a covariate; treatment group and randomization stratum as fixed effects.|||5.86|-5.66|
70992599|NCT04804033|141493132|OTHER||Difference in LSM|-9.0|||||TWO_SIDED|97.5|-18.1|0.19|||||Linear regression model had the following variables: Week 12 change from baseline in domain score as the dependent variable; baseline domain score as a covariate; treatment group and randomization stratum as fixed effects.|||0.19|-18.10|
71099017|NCT03093246|141706792|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Generalized Estimated Equations|||||||<0.05
71099018|NCT03093246|141706793|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Generalized Estimated Equations|||||||<0.05
71099019|NCT03093246|141706794|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Generalized Estimated Equations|||||||<0.05
70992600|NCT04804033|141493132|OTHER||Difference in LSM|-9.3|||||TWO_SIDED|97.5|-18.95|0.41|||||Linear regression model had the following variables: Week 12 change from baseline in domain score as the dependent variable; baseline domain score as a covariate; treatment group and randomization stratum as fixed effects.|||0.41|-18.95|
71099020|NCT04641975|141706798|SUPERIORITY||LS Mean difference|2.22|STANDARD_ERROR_OF_MEAN|1.34||0.121|TWO_SIDED|90.0|-0.15|4.59|||ANCOVA|||Analysis of Covariance (ANCOVA) was performed with change from baseline at week 12 Last Observation Carried Forward (LOCF) as response, treatment group, sex and geographical region as fixed effects and the mean number of micturitions per 24 hours at baseline as covariate.||4.59|-0.15|0.121
70992601|NCT00543569|141493156|NON_INFERIORITY_OR_EQUIVALENCE|The aim of this study was to assess the non-inferiority of each experimental arm (Arms 2-4) to a comparator regimen (Arm 1) over a non-inferiority margin of 10%. If the upper bound of the 90% confidence interval was less than the margin, i.e., 10%, then the test treatment was considered to be non-inferior to the comparator regimen.|Difference|13.6|||||TWO_SIDED|90.0|3.2|23.9|||||A positive difference indicates a higher failure rate in the experimental arm as compared to the comparator arm (Arm 1).|||23.9|3.2|
71039544|NCT03086135|141587026|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive Speech Recognition in Noise with Osia at 3 months vs reference device BP110 on softband at visit 1.||||<0.0001
70992602|NCT00543569|141493156|NON_INFERIORITY_OR_EQUIVALENCE|The aim of this study was to assess the non-inferiority of each experimental arm (Arms 2-4) to a comparator regimen (Arm 1) over a non-inferiority margin of 10%. If the upper bound of the 90% confidence interval was less than the margin, i.e., 10%, then the test treatment was considered to be non-inferior to the comparator regimen.|Difference|6.1|||||TWO_SIDED|90.0|-3.6|15.8|||||A positive difference indicates a higher failure rate in the experimental arm as compared to the comparator arm (Arm 1).|||15.8|-3.6|
70992603|NCT00543569|141493156|NON_INFERIORITY_OR_EQUIVALENCE|The aim of this study was to assess the non-inferiority of each experimental arm (Arms 2-4) to a comparator regimen (Arm 1) over a non-inferiority margin of 10%. If the upper bound of the 90% confidence interval was less than the margin, i.e., 10%, then the test treatment was considered to be non-inferior to the comparator regimen.|Difference|4.0|||||TWO_SIDED|90.0|-5.3|13.3|||||A positive difference indicated a higher failure rate in the experimental arm as compared to the comparator arm (Arm 1).|||13.3|-5.3|
70992604|NCT00543569|141493157|SUPERIORITY_OR_OTHER||Difference|-1.4|||||TWO_SIDED|90.0|-6.9|4.1||||||Patient survival at 6 months||4.1|-6.9|
70992605|NCT00543569|141493157|SUPERIORITY_OR_OTHER||Difference|1.1|||||TWO_SIDED|90.0|-3.5|5.8||||||Patient survival at 6 months||5.8|-3.5|
70992606|NCT00543569|141493157|SUPERIORITY_OR_OTHER||Difference|-2.6|||||TWO_SIDED|90.0|-8.4|3.2||||||Patient survival at 6 months||3.2|-8.4|
70992607|NCT00543569|141493157|SUPERIORITY_OR_OTHER||Difference|4.9|||||TWO_SIDED|90.0|-3.1|12.8||||||Patient survival at 12 months||12.8|-3.1|
70992608|NCT00543569|141493157|SUPERIORITY_OR_OTHER||Difference|0.5|||||TWO_SIDED|90.0|-8.3|9.2||||||Patient survival at 12 months||9.2|-8.3|
70992609|NCT00543569|141493157|SUPERIORITY_OR_OTHER||Difference|2.4|||||TWO_SIDED|90.0|-6.0|10.8||||||Patient survival at 12 months||10.8|-6.0|
70992610|NCT00543569|141493158|SUPERIORITY_OR_OTHER||Difference|-2.7|||||TWO_SIDED|90.0|-8.5|3.1||||||Graft survival at 6 months||3.1|-8.5|
70992611|NCT00543569|141493158|SUPERIORITY_OR_OTHER||Difference|-0.2|||||TWO_SIDED|90.0|-5.3|4.9||||||Graft survival at 6 months||4.9|-5.3|
70992612|NCT00543569|141493158|SUPERIORITY_OR_OTHER||Difference|-3.9|||||TWO_SIDED|90.0|-10.0|2.2||||||Graft survival at 6 months||2.2|-10.0|
70992613|NCT00543569|141493158|SUPERIORITY_OR_OTHER||Difference|3.6|||||TWO_SIDED|90.0|-4.6|11.7||||||Graft survival at 12 months||11.7|-4.6|
70992614|NCT00543569|141493158|SUPERIORITY_OR_OTHER||Difference|-0.9|||||TWO_SIDED|90.0|-9.9|8.1||||||Graft survival at 12 months||8.1|-9.9|
70992615|NCT00543569|141493158|SUPERIORITY_OR_OTHER||Difference|-1.6|||||TWO_SIDED|90.0|-10.6|7.4||||||Graft survival at 12 months||7.4|-10.6|
70992616|NCT00543569|141493159|SUPERIORITY_OR_OTHER||Difference|13.7|||||TWO_SIDED|90.0|2.8|24.6||||||||24.6|2.8|
71099021|NCT04641975|141706799|SUPERIORITY||Mean Difference (Final Values)|-15.51|STANDARD_ERROR_OF_MEAN|18.91||0.43|TWO_SIDED|90.0|-49.47|18.46|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 without LOCF as response, treatment group, sex and geographical region as fixed effects and the mean volume voided per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||18.46|-49.47|0.430
70992617|NCT00543569|141493159|SUPERIORITY_OR_OTHER||Difference|4.8|||||TWO_SIDED|90.0|-5.4|15.0||||||||15.0|-5.4|
70992618|NCT00543569|141493159|SUPERIORITY_OR_OTHER||Difference|2.8|||||TWO_SIDED|90.0|-7.1|12.6||||||||12.6|-7.1|
70992619|NCT00543569|141493160|SUPERIORITY_OR_OTHER||Difference|10.6|||||TWO_SIDED|90.0|1.8|19.5||||||BCAR at Month 6||19.5|1.8|
70992620|NCT00543569|141493160|SUPERIORITY_OR_OTHER||Difference|4.3|||||TWO_SIDED|90.0|-3.6|12.3||||||BCAR at Month 6||12.3|-3.6|
70992621|NCT00543569|141493160|SUPERIORITY_OR_OTHER||Difference|6.4|||||TWO_SIDED|90.0|-1.7|14.6||||||BCAR at Month 6||14.6|-1.7|
70992622|NCT00543569|141493160|SUPERIORITY_OR_OTHER||Difference|12.0|||||TWO_SIDED|90.0|3.0|21.0||||||BCAR at Month 12||21.0|3.0|
70992623|NCT00543569|141493160|SUPERIORITY_OR_OTHER||Difference|4.3|||||TWO_SIDED|90.0|-3.6|12.3||||||BCAR at Month 12||12.3|-3.6|
70992624|NCT00543569|141493160|SUPERIORITY_OR_OTHER||Difference|7.8|||||TWO_SIDED|90.0|-0.6|16.2||||||BCAR at Month 12||16.2|-0.6|
70992625|NCT00543569|141493161|SUPERIORITY_OR_OTHER||Difference|12.2|||||TWO_SIDED|90.0|2.0|22.5||||||T-cell Mediated BCAR at Month 6||22.5|2.0|
70992626|NCT00543569|141493161|SUPERIORITY_OR_OTHER||Difference|6.1|||||TWO_SIDED|90.0|-3.6|15.8||||||T-cell Mediated BCAR at Month 6||15.8|-3.6|
70992627|NCT00543569|141493161|SUPERIORITY_OR_OTHER||Difference|4.0|||||TWO_SIDED|90.0|-5.3|13.3||||||T-cell Mediated BCAR at Month 6||13.3|-5.3|
70992628|NCT00543569|141493161|SUPERIORITY_OR_OTHER||Difference|13.6|||||TWO_SIDED|90.0|3.0|24.3||||||T-cell Mediated BCAR at Month 12||24.3|3.0|
70992629|NCT00543569|141493161|SUPERIORITY_OR_OTHER||Difference|4.8|||||TWO_SIDED|90.0|-5.1|14.6||||||T-cell Mediated BCAR at Month 12||14.6|-5.1|
70992630|NCT00543569|141493161|SUPERIORITY_OR_OTHER||Difference|4.1|||||TWO_SIDED|90.0|-5.6|13.8||||||T-cell Mediated BCAR at Month 12||13.8|-5.6|
70992631|NCT00543569|141493162|SUPERIORITY_OR_OTHER||Difference|9.3|||||TWO_SIDED|90.0|0.7|18.0||||||T-cell Mediated BCAR at Month 6||18.0|0.7|
70992632|NCT00543569|141493162|SUPERIORITY_OR_OTHER||Difference|4.3|||||TWO_SIDED|90.0|-3.6|12.3||||||T-cell Mediated BCAR at Month 6||12.3|-3.6|
70992633|NCT00543569|141493162|SUPERIORITY_OR_OTHER||Difference|6.4|||||TWO_SIDED|90.0|-1.7|14.6||||||T-cell Mediated BCAR at Month 6||14.6|-1.7|
71039545|NCT03086135|141587026|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive Speech Recognition in Noise with Osia at 6 months vs reference device BP110 on softband at visit 1.||||<0.0001
71039546|NCT03086135|141587026|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive Speech Recognition in Noise with Osia at 12 months vs reference device BP110 on softband at visit 1.||||<0.0001
71039547|NCT00762411|141587042|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Mixed Models Analysis|||||||0.560
71039548|NCT00762411|141587043|SUPERIORITY_OR_OTHER|||||||0.959||95.0|||||Mixed Models Analysis|||||||0.959
71039549|NCT00762411|141587044|SUPERIORITY_OR_OTHER|||||||0.567||95.0|||||Mixed Models Analysis|||||||0.567
71039550|NCT00762411|141587045|SUPERIORITY_OR_OTHER|||||||0.199||95.0|||||Mixed Models Analysis|||||||0.199
71039551|NCT00762411|141587046|SUPERIORITY_OR_OTHER|||||||0.294||95.0|||||Mixed Models Analysis|||||||0.294
71039552|NCT00762411|141587047|SUPERIORITY_OR_OTHER|||||||0.477||95.0|||||Mixed Models Analysis|||||||0.477
71039553|NCT00762411|141587048|SUPERIORITY_OR_OTHER|||||||0.673||95.0|||||ANCOVA|||||||0.673
71099022|NCT04641975|141706799|SUPERIORITY||Mean Difference (Final Values)|-15.51|STANDARD_ERROR_OF_MEAN|18.91||0.43|TWO_SIDED|90.0|-49.47|18.46|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 with LOCF as response, treatment group, sex and geographical region as fixed effects and the mean volume voided per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||18.46|-49.47|0.430
70923336|NCT04505774|141337941|SUPERIORITY|||||||0.9661|||||||Chi-squared|||||||.9661
71039554|NCT00762411|141587049|SUPERIORITY_OR_OTHER|||||||0.622||95.0|||||Mixed Models Analysis|||||||0.622
71039555|NCT00762411|141587050|SUPERIORITY_OR_OTHER|||||||0.178||95.0|||||Mixed Models Analysis|||||||0.178
71039556|NCT00762411|141587051|SUPERIORITY_OR_OTHER|||||||0.632||95.0|||||Mixed Models Analysis|||||||0.632
71099023|NCT04641975|141706800|SUPERIORITY||Mean Difference (Final Values)|2.58|STANDARD_ERROR_OF_MEAN|31.08||0.935|TWO_SIDED|90.0|-53.23|58.38|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 without LOCF as response, treatment group, sex and geographical region as fixed effects and the mean volume voided per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||58.38|-53.23|0.935
70923337|NCT04505774|141337941|SUPERIORITY|||||||0.1073|||||||Chi-squared|||||||.1073
70923338|NCT04505774|141337942|SUPERIORITY|||||||0.3575|||||||Chi-squared|||||||.3575
70923339|NCT04505774|141337942|SUPERIORITY|||||||0.591|||||||Chi-squared|||||||.5910
70923340|NCT04505774|141337942|SUPERIORITY|||||||0.867|||||||Chi-squared|||||||.8670
70923341|NCT04505774|141337942|SUPERIORITY|||||||0.0645|||||||Chi-squared|||||||.0645
70923342|NCT02815813|141337943|SUPERIORITY||||||<|0.01|||||||GLMM|||||||<0.01
71039557|NCT00762411|141587052|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANCOVA|||||||0.009
71039558|NCT00762411|141587053|SUPERIORITY_OR_OTHER|||||||0.426||95.0|||||ANCOVA|||||||0.426
71039559|NCT00762411|141587054|SUPERIORITY_OR_OTHER|||||||0.101||95.0||||This is the p-value for the Right Hippocampal Volume.|ANCOVA|||||||0.101
71039560|NCT00762411|141587054|SUPERIORITY_OR_OTHER|||||||0.772||95.0||||This is the p-value for the Left Hippocampal Volume.|ANCOVA|||||||0.772
71039561|NCT00762411|141587055|SUPERIORITY_OR_OTHER|||||||0.326||95.0|||||ANCOVA|||||||0.326
71039562|NCT00762411|141587056|SUPERIORITY_OR_OTHER|||||||0.117||95.0|||||ANCOVA|||||||0.117
71039563|NCT00762411|141587065|SUPERIORITY_OR_OTHER|||||||0.929||95.0|||||Mixed Models Analysis|||||||0.929
71039564|NCT00762411|141587066|SUPERIORITY_OR_OTHER|||||||0.437||95.0|||||Mixed Models Analysis|||||||0.437
71039565|NCT00762411|141587067|SUPERIORITY_OR_OTHER|||||||0.318||95.0|||||ANCOVA|||||||0.318
71039566|NCT00762411|141587068|SUPERIORITY_OR_OTHER|||||||0.417||95.0|||||ANCOVA|||||||0.417
71039567|NCT00762411|141587069|SUPERIORITY_OR_OTHER|||||||0.805||95.0|||||Mixed Models Analysis|||||||0.805
71039568|NCT00762411|141587070|SUPERIORITY_OR_OTHER|||||||0.893||95.0|||||Mixed Models Analysis|||||||0.893
71039569|NCT01023061|141587071|SUPERIORITY||Median Difference (Final Values)|0.74|||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||< 0.01
71039570|NCT02959840|141587074|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.|||||<|1e-05|||||||Chi-squared|||||||< 0.00001
71039571|NCT02959840|141587074|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||5e-05|||||||Chi-squared|||||||0.00005
71039572|NCT02959840|141587074|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.1|||||||Chi-squared|||||||0.1
71039573|NCT02959840|141587075|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.001|||||||Chi-squared|||||||0.001
71039574|NCT02959840|141587075|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.0002|||||||Chi-squared|||||||0.0002
71039575|NCT02959840|141587075|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.8|||||||Chi-squared|||||||0.8
71039576|NCT02959840|141587076|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||4e-05|||||||Chi-squared|||||||0.00004
71039577|NCT02959840|141587076|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.0004|||||||Chi-squared|||||||0.0004
71039578|NCT02959840|141587076|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.09|||||||Chi-squared|||||||0.09
70923343|NCT02815813|141337944|SUPERIORITY||||||<|0.01|||||||GLMM|||||||<0.01
70992634|NCT00543569|141493162|SUPERIORITY_OR_OTHER||Difference|10.7|||||TWO_SIDED|90.0|1.8|19.5||||||T-cell Mediated BCAR at Month 12||19.5|1.8|
70992635|NCT00543569|141493162|SUPERIORITY_OR_OTHER||Difference|4.3|||||TWO_SIDED|90.0|-3.6|12.3||||||T-cell Mediated BCAR at Month 12||12.3|-3.6|
70992636|NCT00543569|141493162|SUPERIORITY_OR_OTHER||Difference|7.8|||||TWO_SIDED|90.0|-0.6|16.2||||||T-cell Mediated BCAR at Month 12||16.2|-0.6|
70992637|NCT00543569|141493166|SUPERIORITY_OR_OTHER||Difference|14.7|||||TWO_SIDED|90.0|3.8|25.5||||||Efficacy Failure at Month 6||25.5|3.8|
70992638|NCT00543569|141493166|SUPERIORITY_OR_OTHER||Difference|7.5|||||TWO_SIDED|90.0|-2.9|17.8||||||Efficacy Failure at Month 6||17.8|-2.9|
70992639|NCT00543569|141493166|SUPERIORITY_OR_OTHER||Difference|7.9|||||TWO_SIDED|90.0|-2.4|18.2||||||Efficacy Failure at Month 6||18.2|-2.4|
70992640|NCT00543569|141493166|SUPERIORITY_OR_OTHER||Difference|8.4|||||TWO_SIDED|90.0|-3.5|20.4||||||Efficacy Failure at Month12||20.4|-3.5|
70992641|NCT00543569|141493166|SUPERIORITY_OR_OTHER||Difference|4.0|||||TWO_SIDED|90.0|-7.8|15.8||||||Efficacy Failure at Month 12||15.8|-7.8|
70992642|NCT00543569|141493166|SUPERIORITY_OR_OTHER||Difference|4.2|||||TWO_SIDED|90.0|-7.5|15.9||||||Efficacy Failure at Month12||15.9|-7.5|
70992643|NCT00543569|141493167|SUPERIORITY_OR_OTHER||Difference|10.7|||||TWO_SIDED|90.0|0.9|20.4||||||Efficacy Failure at Month 6||20.4|0.9|
70992644|NCT00543569|141493167|SUPERIORITY_OR_OTHER||Difference|4.6|||||TWO_SIDED|90.0|-4.5|13.7||||||Efficacy Failure at Month 6||13.7|-4.5|
70992645|NCT00543569|141493167|SUPERIORITY_OR_OTHER||Difference|9.1|||||TWO_SIDED|90.0|-0.4|18.7||||||Efficacy Failure at Month 6||18.7|-0.4|
70992646|NCT00543569|141493167|SUPERIORITY_OR_OTHER||Difference|7.0|||||TWO_SIDED|90.0|-4.0|18.0||||||Efficacy Failure at Month 12||18.0|-4.0|
70992647|NCT00543569|141493167|SUPERIORITY_OR_OTHER||Difference|2.3|||||TWO_SIDED|90.0|-8.3|13.0||||||Efficacy Failure at Month 12||13.0|-8.3|
70992648|NCT00543569|141493167|SUPERIORITY_OR_OTHER||Difference|6.7|||||TWO_SIDED|90.0|-4.2|17.6||||||Efficacy Failure at Month 12||17.6|-4.2|
70992649|NCT00543569|141493177|SUPERIORITY_OR_OTHER||Difference|11.1|||||TWO_SIDED|90.0|-1.1|23.3||||||Treatment Failure at Month 6||23.3|-1.1|
70992650|NCT00543569|141493177|SUPERIORITY_OR_OTHER||Difference|11.8|||||TWO_SIDED|90.0|-0.7|24.2||||||Treatment Failure at Month 6||24.2|-0.7|
70923344|NCT04995484|141337959|OTHER||Geometric Mean Ratio|1.52|||||TWO_SIDED|90.0|0.95|2.43|||||Moderate Hepatic Impairment/Healthy|||2.43|0.95|
70923345|NCT04995484|141337960|OTHER||Geometric Mean Ratio|1.09|||||TWO_SIDED|90.0|0.84|1.42|||||Moderate Hepatic Impairment/Healthy|||1.42|0.84|
70923346|NCT04995484|141337961|OTHER||Geometric Mean Ratio|0.98|||||TWO_SIDED|90.0|0.76|1.26|||||Moderate Hepatic Impairment/Healthy|||1.26|0.76|
70923347|NCT05136404|141337991|OTHER||Ratio of Geometric Least Squares Mean|1.0|||||TWO_SIDED|90.0|0.937|1.08|||Mixed Models Analysis|||||1.08|0.937|
70923348|NCT05136404|141337991|OTHER||Ratio of Geometric Least Squares Mean|1.04|||||TWO_SIDED|90.0|0.968|1.11|||Mixed Models Analysis|||||1.11|0.968|
70992651|NCT00543569|141493177|SUPERIORITY_OR_OTHER||Difference|2.9|||||TWO_SIDED|90.0|-8.9|14.7||||||Treatment Failure at Month 6||14.7|-8.9|
70992652|NCT00543569|141493177|SUPERIORITY_OR_OTHER||Difference|10.0|||||TWO_SIDED|90.0|-2.9|22.8||||||Treatment Failure at Month 12||22.8|-2.9|
70992653|NCT00543569|141493177|SUPERIORITY_OR_OTHER||Difference|9.7|||||TWO_SIDED|90.0|-3.3|22.8||||||Treatment Failure at Month 12||22.8|-3.3|
70992654|NCT00543569|141493177|SUPERIORITY_OR_OTHER||Difference|-0.8|||||TWO_SIDED|90.0|-13.3|11.7||||||Treatment Failure at Month 12||11.7|-13.3|
70992655|NCT01968187|141493241|OTHER||LS Mean Difference|-6.7||||0.029|ONE_SIDED|90.0||-2.2|||ANCOVA|Treatment groups were compared using ANCOVA model with treatment and site as fixed effect and HPWSQ-R total score at baseline as covariate.||||-2.2||0.0290
70992656|NCT01968187|141493242|OTHER||LS Mean Difference|-0.8||||0.0233|ONE_SIDED|90.0||-0.3|||ANCOVA|Treatment groups were compared using ANCOVA model with treatment and site as fixed effects and CGI-S score as a covariate.||||-0.3||0.0233
70992657|NCT01968187|141493243|OTHER||LS Mean Difference|-2.0||||0.1172|ONE_SIDED|90.0||0.2|||ANCOVA|Treatment groups were compared using ANCOVA model with treatment and site as fixed effects and HPWSQ-R domain score at baseline as a covariate.||HPWSQ-R Domain score: Behavior||0.2||0.1172
70992658|NCT01968187|141493243|OTHER||LS Mean Difference|-1.6||||0.1436|ONE_SIDED|90.0||0.3|||ANCOVA|Treatment groups were compared using ANCOVA model with treatment and site as fixed effects and HPWSQ-R domain score -at baseline as a covariate.||HPWSQ-R Domain score: Drive||0.3||0.1436
70992659|NCT01968187|141493243|OTHER||LS Mean Difference|-1.5||||0.0248|ONE_SIDED|90.0||-0.5|||ANCOVA|Treatment groups were compared using ANCOVA model with treatment and site as fixed effects and HPWSQ-R domain score -at baseline as a covariate.||HPWSQ-R Domain score: Severity||-0.5||0.0248
70992660|NCT01968187|141493244|OTHER||LS mean difference|-6.2||||0.0047|ONE_SIDED|90.0||-3.3|||ANCOVA|From ANCOVA model with treatment and site as fixed effects and CY-BOCS total score at baseline as a covariate.||||-3.3||0.0047
70992661|NCT01968187|141493245|OTHER||LS mean difference|-4.4||||0.0132|ONE_SIDED|90.0||-1.9|||ANCOVA|Compared using ANCOVA model with treatment and site as fixed effects and Food Domain Score of Reiss Profile at baseline as a covariate.||||-1.9||0.0132
70992662|NCT04095286|141493246|OTHER||Ratio of adjusted geometric mean|1.03|||||TWO_SIDED|90.0|0.96|1.11|||||Treatment comparison between AMB dispersed in water and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented|||1.11|0.96|
70923349|NCT05136404|141337992|OTHER||Ratio of Geometric Least Squares Mean|0.989|||||TWO_SIDED|90.0|0.953|1.03|||Mixed Models Analysis|||||1.03|0.953|
70992663|NCT04095286|141493246|OTHER||Ratio of adjusted geometric mean|0.91|||||TWO_SIDED|90.0|0.85|0.98|||||Treatment comparison between AMB oral tablet and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented|||0.98|0.85|
70923350|NCT05136404|141337992|OTHER||Ratio of Geometric Least Squares Mean|1.02|||||TWO_SIDED|90.0|0.982|1.06|||Mixed Models Analysis|||||1.06|0.982|
70923351|NCT05136404|141337993|OTHER||Ratio of Geometric Least Squares Mean|1.01|||||TWO_SIDED|90.0|0.972|1.06|||Mixed Models Analysis|||||1.06|0.972|
70923352|NCT05136404|141337993|OTHER||Ratio of Geometric Least Squares Mean|1.03|||||TWO_SIDED|90.0|0.992|1.08|||Mixed Models Analysis|||||1.08|0.992|
70923353|NCT05136404|141337994|SUPERIORITY||Median Difference (Final Values)|0.0||||0.4728|TWO_SIDED|90.0|-0.5|0.0|||Sign test|||||0.00|-0.50|0.4728
70992664|NCT04095286|141493249|OTHER||Ratio of adjusted geometric mean|1.05|||||TWO_SIDED|90.0|1.02|1.09|||||Treatment comparison between AMB dispersed in water and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented|||1.09|1.02|
70992665|NCT04095286|141493249|OTHER||Ratio of adjusted geometric mean|1.04|||||TWO_SIDED|90.0|1.0|1.08|||||Treatment comparison between AMB oral tablet and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented|||1.08|1.00|
70992666|NCT04095286|141493250|OTHER||Ratio of adjusted geometric mean|1.05|||||TWO_SIDED|90.0|1.02|1.08|||||Treatment comparison between AMB dispersed in water and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented|||1.08|1.02|
70992667|NCT04095286|141493250|OTHER||Ratio of adjusted geometric mean|1.04|||||TWO_SIDED|90.0|1.01|1.07|||||Treatment comparison between AMB oral tablet and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented|||1.07|1.01|
70992668|NCT02604810|141493263|NON_INFERIORITY|Method of estimation = least-squares means based on analysis of variance (ANOVA) with a mixed-effect model. The lower bound of the 90% confidence interval (CI) for the geometric LSM ratio (SC/IV) of the primary PK endpoint of steady state AUC0-7 days for the PK population should be above 0.80.|Geometric least-squares mean ratio|1.04|||||TWO_SIDED|90.0|1.0|1.07||||||||1.07|1.00|
70992669|NCT01313520|141493281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||<|0.001|TWO_SIDED|95.0|-0.4|-0.1|||Constrained Longitudinal Data Analysis|||||-0.1|-0.4|<0.001
70992670|NCT01313520|141493282|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||Fisher Exact|||||||0.048
70992671|NCT01313520|141493283|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||Fisher Exact|||||||0.011
70992672|NCT01313520|141493284|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Constrained longitudinal data analysis|||||||<0.0001
70992673|NCT01313520|141493285|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||van Elteren test|||||||0.001
70992674|NCT01313520|141493286|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||van Elteren test|||||||0.0005
70992675|NCT01313520|141493287|SUPERIORITY_OR_OTHER||Effect Size|1.4|||||TWO_SIDED|90.0|0.92|1.87||||||||1.87|0.92|
70992676|NCT01313520|141493288|SUPERIORITY_OR_OTHER||Effect Size|1.1|||||TWO_SIDED|90.0|0.64|1.55||||||||1.55|0.64|
70992677|NCT03209440|141493289|SUPERIORITY||Mean Difference (Net)|1.67|STANDARD_ERROR_OF_MEAN|0.73||0.02|TWO_SIDED||||||Regression, Linear|||||||0.02
70992678|NCT03209440|141493289|SUPERIORITY||Mean Difference (Net)|2.07|STANDARD_ERROR_OF_MEAN|0.74||0.005|TWO_SIDED||||||Regression, Linear|||||||0.005
70992679|NCT03209440|141493290|SUPERIORITY||Mean Difference (Net)|-0.62|STANDARD_ERROR_OF_MEAN|0.49||0.21|TWO_SIDED||||||Regression, Linear|||||||0.21
70992680|NCT03209440|141493290|SUPERIORITY||Median Difference (Net)|-0.79|STANDARD_ERROR_OF_MEAN|0.5||0.12|TWO_SIDED||||||Regression, Linear|||||||0.12
70992681|NCT03209440|141493291|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|0.72||0.21|TWO_SIDED||||||Regression, Linear|||||||0.21
70992682|NCT03209440|141493291|SUPERIORITY||Mean Difference (Net)|0.91|STANDARD_ERROR_OF_MEAN|0.73||0.21|TWO_SIDED||||||Regression, Linear|||||||0.21
70992683|NCT03209440|141493292|SUPERIORITY||Odds Ratio, log|1.0|STANDARD_ERROR_OF_MEAN|0.62||0.11|TWO_SIDED||||||Regression, Logistic|||||||0.11
70992684|NCT03209440|141493292|SUPERIORITY||Odds Ratio, log|0.96|STANDARD_ERROR_OF_MEAN|0.64||0.14|TWO_SIDED||||||Regression, Logistic|||||||0.14
70992685|NCT03209440|141493293|SUPERIORITY||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.17||0.05|TWO_SIDED||||||Regression, Linear|"The outcome variable was scored as 1= prolong life; treat everything to 4 = provide comfort care only."||||||0.05
70992686|NCT03209440|141493293|SUPERIORITY||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.18||0.46|TWO_SIDED||||||Regression, Linear|"The outcome variable was scored as 1= prolong life; treat everything to 4 = provide comfort care only."||||||0.46
70992687|NCT04348656|141493300|SUPERIORITY||Risk Ratio (RR)|1.16||||0.18|TWO_SIDED|95.0|0.94|1.43|||wald test|||||1.43|0.94|0.18
70992688|NCT04348656|141493301|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.3|TWO_SIDED|95.0|0.89|1.47|||Regression, Cox|||||1.47|0.89|0.30
70992689|NCT04348656|141493302|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.41|TWO_SIDED|95.0|-2.1|0.7|||t-test, 2 sided|bootstrap estimates based on resampling process|bootstrap estimates based on resampling process|||0.7|-2.1|0.41
70992690|NCT04348656|141493303|SUPERIORITY||Risk Ratio (RR)|1.12||||0.4|TWO_SIDED|95.0|0.86|1.46|||wald test|||||1.46|0.86|0.40
70992691|NCT04348656|141493304|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.22|TWO_SIDED|95.0|-0.3|1.7|||t-test, 2 sided|||||1.7|-0.3|0.22
70992692|NCT04348656|141493305|SUPERIORITY||Risk Ratio (RR)|0.83||||0.72|TWO_SIDED|95.0|0.31|2.27|||t-test, 2 sided|bootstrap estimates based on resampling process|bootstrap estimates based on resampling process|||2.27|0.31|0.72
70992693|NCT04348656|141493308|SUPERIORITY||Risk Ratio (RR)|1.13||||0.33|TWO_SIDED|95.0|0.88|1.45|||wald test|||||1.45|0.88|0.33
70992694|NCT04348656|141493309|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.91|TWO_SIDED|95.0|0.76|1.35|||Regression, Cox|competing risk analysis|competing risk analysis|||1.35|0.76|0.91
70992695|NCT04348656|141493310|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.18|TWO_SIDED|95.0|0.8|1.04|||Regression, Cox|||||1.04|0.80|0.18
70992696|NCT04348656|141493311|SUPERIORITY||Risk Ratio (RR)|1.53||||0.03|TWO_SIDED|95.0|1.04|2.26|||wald test|||||2.26|1.04|0.03
70992697|NCT04348656|141493311|SUPERIORITY||Hazard Ratio (HR)|1.7||||0.02|TWO_SIDED|95.0|1.08|2.69|||Regression, Cox|competing risk analysis|competing risk analysis|The cumulative incidence of Grade 3 and 4 serious AEs is described as a hazard ratio.||2.69|1.08|0.02
71039579|NCT02959840|141587077|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.1|||||||Chi-squared|||||||0.1
70923354|NCT05136404|141337994|SUPERIORITY||Median Difference (Final Values)|0.0||||0.0142|TWO_SIDED|90.0|-0.5|0.0|||Sign test|||||0.00|-0.50|0.0142
71039580|NCT02959840|141587077|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.07|||||||Chi-squared|||||||0.07
70992698|NCT04348656|141493313|SUPERIORITY||Risk Ratio (RR)|1.27||||0.03|TWO_SIDED|95.0|1.02|1.57|||wald test|||||1.57|1.02|0.03
70992699|NCT04348656|141493316|OTHER|Incremental cost per quality-adjusted life day gained (ICER)- this is a summary measure of the cost-effectiveness of the intervention, compared to the control group. This is calculated using the cost (derived from cost of the intervention and cost of hospital stay based on the payer's perspective) per patient and the quality-adjusted life days calculated using the EQ-5D-5L results.|ICER (CAD)|-44623.01|||||TWO_SIDED|95.0|-525369.24|436123.22|||||ICER is reported in Canadian dollars. 95% CI is calculated by 1000 bootstrap sampling using bias-corrected accelerated method.|||436123.22|-525369.24|
70992700|NCT02665364|141493368|SUPERIORITY||arithmetic mean|-30.2802|STANDARD_ERROR_OF_MEAN|5.2588|<|0.0001|TWO_SIDED|95.0|-40.6653|-19.8951|||ANCOVA|||The percent of change from baseline to last available value between W24 and W36 of treatment in the expression of IFN-induced genes was analyzed using an analysis of covariance (ANCOVA) model.||-19.8951|-40.6653|< 0.0001
70992701|NCT02665364|141493369|SUPERIORITY||Odds Ratio (OR)|1.38||||0.34|TWO_SIDED|95.0|0.716|2.657|||Regression, Logistic|||Descriptive statistics for the response to treatment according to BICLA at week 36 were presented by treatment group. The response to treatment according to BICLA was analyzed using a logistic regression with the response rate as dependent variable and treatment as independent variable, while adjusting for the minimization factors used for randomization.||2.657|0.716|0.34
70992702|NCT02665364|141493370|SUPERIORITY||Odds Ratio (OR)|1.18||||0.6243|TWO_SIDED|95.0|0.602|2.329|||Regression, Logistic|||The SRI-4 response was analyzed using a logistic regression using the response rate as dependent variable and treatment as independent variable, while adjusting for the minimization factors used for randomization.||2.329|0.602|0.6243
70992703|NCT02665364|141493371|SUPERIORITY|||||||0.0022|||||||Pearson's Chi-squared|||||||0.0022
70992704|NCT02665364|141493372|SUPERIORITY|||||||0.7946|||||||Wilcoxon (Mann-Whitney)|||Baseline to last available value between W24 and W36||||0.7946
70992705|NCT02665364|141493373|SUPERIORITY|||||||0.9224|||||||student - pooled|||||||0.9224
70992706|NCT02665364|141493374|SUPERIORITY|||||||0.3258|||||||student - pooled|||||||0.3258
70992707|NCT02665364|141493375|SUPERIORITY|||||||0.6169|||||||Student - Satterthwaite|||||||0.6169
70992708|NCT02665364|141493376|SUPERIORITY||Odds Ratio (OR)|1.81||||0.0796|TWO_SIDED|95.0|0.932|3.524|||Regression, Logistic|||||3.524|0.932|0.0796
70992709|NCT02665364|141493377|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0762|TWO_SIDED|95.0|0.938|3.574|||Regression, Logistic|||||3.574|0.938|0.0762
70923355|NCT05343390|141338045|SUPERIORITY||Mean Difference (Final Values)|20.6|||<|0.001|TWO_SIDED|95.0|16.1|25.1|||Regression, Linear|A linear model fit using generalized estimating equations to account for correlated observations within clusters.||||25.1|16.1|<0.001
70923356|NCT05343390|141338046|SUPERIORITY||Mean Difference (Final Values)|11.1|||<|0.001|TWO_SIDED|95.0|5.9|16.4|||Regression, Linear|A linear model fit using generalized estimating equations to account for correlated observations within clusters.||||16.4|5.9|<0.001
70992710|NCT02665364|141493380|SUPERIORITY|||||||0.0097|||||||Student - Satterthwaite|||||||0.0097
70992711|NCT02665364|141493381|SUPERIORITY|||||||0.0425|||||||Pearson's Chi-squared|||||||0.0425
70992712|NCT02665364|141493382|SUPERIORITY|||||||0.0396|||||||Pearson's Chi-squared|||||||0.0396
70992713|NCT03888391|141493383|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|Time: F = 1.72, df = 1/34||Outcomes fitted via a mixed model with time as a predictor.||||.20
70992714|NCT03888391|141493385|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Time: F = 44.47, df = 1/33||Outcomes fitted via a mixed model with time as a predictor.||||<.0001
70992715|NCT03888391|141493386|SUPERIORITY|||||||0.0004|||||||Mixed Models Analysis|Time: F = 15.74, df = 1/34||Outcomes fitted via a mixed model with time as a predictor.||||.0004
71039581|NCT02959840|141587077|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.7|||||||Chi-squared|||||||0.7
71039582|NCT02959840|141587078|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.7|||||||Chi-squared|||||||0.7
71039583|NCT02959840|141587078|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.7|||||||Chi-squared|||||||0.7
71039584|NCT02959840|141587078|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.2|||||||Chi-squared|||||||0.2
70992716|NCT03888391|141493387|SUPERIORITY|||||||0.6|||||||Mixed Models Analysis|Time: F = .28, df = 1/34||Outcomes fitted via a mixed model with time as a predictor.||||.60
70992717|NCT03888391|141493388|SUPERIORITY|||||||0.32|||||||Mixed Models Analysis|Time: F = 1.04, df = 1/34||Outcomes fitted via a mixed model with time as a predictor.||||.32
70992718|NCT03888391|141493389|SUPERIORITY|||||||0.27|||||||Mixed Models Analysis|Time: F = 1.27, df = 1/34||Outcomes fitted via a mixed model with time as a predictor.||||.27
70992719|NCT00423735|141493406|SUPERIORITY|||||||0.99|||||||Fisher Exact|2-sided test||||||0.99
70992720|NCT01954251|141493416|NON_INFERIORITY_OR_EQUIVALENCE|Comparison at one month after the last dose of HZ/su was performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non-inferior compared to the Control group in terms of immunogenicity if the UL of the 2-sided 95% CI of the ratio of GMs between the Control and the Co-Ad group (Control over GSK1437173A + GSK2321138A) was below 1.5.|Adjusted Geometric mean concentration ra|1.08|||||TWO_SIDED|95.0|0.97|1.2||||||Adjusted ratios of Control group over GSK1437173A + GSK2321138A group in anti-gE antibody ELISA concentrations GMCs at one month after last vaccine dose. An Analysis of Covariance (ANCOVA) model was used to analyse post-vaccination log-transformed concentrations of anti-gE. The fixed-effect model included the minimisation variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate.||1.20|0.97|
70992721|NCT01954251|141493417|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons at Day 21 after the FLU-D-QIV dose were performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non inferior compared to the Control group in terms of immunogenicity (for each strain) if the UL of 2-sided 95% CI of the ratio of GMTs between the Control and the GSK1437173A + GSK2321138A (Control/ GSK1437173A + GSK2321138A) group is below 1.5.|Adjusted geometric mean Titer ratio|1.04|||||TWO_SIDED|95.0|0.88|1.22||||||For the Flu A/California/7/2009 H1N1 strain ,an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. GMs of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for this strain.||1.22|0.88|
70992722|NCT01954251|141493417|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons at Day 21 after the FLU-D-QIV dose were performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non inferior compared to the Control group in terms of immunogenicity (for each strain) if the UL of 2-sided 95% CI of the ratio of GMTs between the Control and the GSK1437173A + GSK2321138A (Control/ GSK1437173A + GSK2321138A) group is below 1.5.|Adjusted geometric mean Titer ratio|1.03|||||TWO_SIDED|95.0|0.91|1.17||||||For the Flu A/Texas/50/2012 H3N2 strain ,an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. GMs of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for this strain.||1.17|0.91|
70992723|NCT01954251|141493417|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons at Day 21 after the FLU-D-QIV dose were performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non inferior compared to the Control group in terms of immunogenicity (for each strain) if the UL of 2-sided 95% CI of the ratio of GMTs between the Control and the GSK1437173A + GSK2321138A (Control/ GSK1437173A + GSK2321138A) group is below 1.5.|Adjusted geometric mean Titer ratio|1.07|||||TWO_SIDED|95.0|0.95|1.2||||||For the Flu B/Brisbane/60/2008 Victoria strain ,an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. GMs of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for this strain.||1.20|0.95|
70992724|NCT01954251|141493417|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons at Day 21 after the FLU-D-QIV dose were performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non inferior compared to the Control group in terms of immunogenicity (for each strain) if the UL of 2-sided 95% CI of the ratio of GMTs between the Control and the GSK1437173A + GSK2321138A (Control/ GSK1437173A + GSK2321138A) group is below 1.5.|Adjusted geometric mean Titer ratio|0.98|||||TWO_SIDED|95.0|0.88|1.09||||||For the Flu B/Massachusetts/2/2012 Yamagata strain ,an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. GMs of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for this strain.||1.09|0.88|
70992725|NCT01722487|141493434|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.16|||<|0.0001|TWO_SIDED|95.0|0.09|0.28|||Log Rank|||||0.28|0.09|<0.0001
70992726|NCT01722487|141493435|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.16||||0.001|TWO_SIDED|95.0|0.05|0.56|||Log Rank|||||0.56|0.05|0.0010
70992727|NCT01722487|141493436|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70992728|NCT01722487|141493437|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
70992729|NCT01722487|141493438|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
70992730|NCT01722487|141493439|SUPERIORITY_OR_OTHER|||||||0.0009|||||||Chi-squared|||||||.0009
70992731|NCT01722487|141493440|SUPERIORITY_OR_OTHER|||||||0.0054|||||||Chi-squared|||||||.0054
70992732|NCT02175771|141493445|SUPERIORITY||geometric mean ratio|1.32|||||TWO_SIDED|90.0|1.02|1.72|||||Fp MDPI / FLOVENT HFA|Mid-strength comparison||1.72|1.02|
70992733|NCT02175771|141493445|SUPERIORITY||geometric mean ratio|0.81|||||TWO_SIDED|90.0|0.63|1.04|||||Fp MDPI / FLOVENT HFA|High-strength comparison||1.04|0.63|
70992734|NCT02175771|141493445|SUPERIORITY||geometric mean ratio|0.96|||||TWO_SIDED|90.0|0.75|1.24|||||FS MDPI / ADVAIR DISKUS|Mid-strength comparison||1.24|0.75|
70992735|NCT02175771|141493445|SUPERIORITY||geometric mean ratio|0.84|||||TWO_SIDED|90.0|0.67|1.06|||||FS MDPI / ADVAIR DISKUS|High-strength comparison||1.06|0.67|
70992736|NCT02175771|141493446|NON_INFERIORITY|The study had reasonable power for demonstrating non-inferiority of the study drug to the comparator drug within each cohort. The statistical analysis plan specified that non-inferiority would be demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) for the treatment difference was greater than -125 mL.|LSM difference|0.009|STANDARD_ERROR_OF_MEAN|0.0476||0.8451|TWO_SIDED|95.0|-0.084|0.103|||mixed model for repeated measures||Fp MDPI / FLOVENT HFA|Mid-strength comparison||0.103|-0.084|0.8451
70992737|NCT02175771|141493446|NON_INFERIORITY|The study had reasonable power for demonstrating non-inferiority of the study drug to the comparator drug within each cohort. The statistical analysis plan specified that non-inferiority would be demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) for the treatment difference was greater than -125 mL.|LSM difference|-0.013|STANDARD_ERROR_OF_MEAN|0.0479||0.7877|TWO_SIDED|95.0|-0.107|0.081|||mixed model for repeated measures||Fp MDPI / FLOVENT HFA|High-strength comparison||0.081|-0.107|0.7877
70992738|NCT02175771|141493446|NON_INFERIORITY|The study had reasonable power for demonstrating non-inferiority of the study drug to the comparator drug within each cohort. The statistical analysis plan specified that non-inferiority would be demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) for the treatment difference was greater than -125 mL.|LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.0485||0.9966|TWO_SIDED|95.0|-0.095|0.095|||mixed model for repeated measures||FS MDPI / ADVAIR DISKUS|Mid-strength comparison||0.095|-0.095|0.9966
70992739|NCT02175771|141493446|NON_INFERIORITY|The study had reasonable power for demonstrating non-inferiority of the study drug to the comparator drug within each cohort. The statistical analysis plan specified that non-inferiority would be demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) for the treatment difference was greater than -125 mL.|LSM difference|0.059|STANDARD_ERROR_OF_MEAN|0.0464||0.2056|TWO_SIDED|95.0|-0.032|0.15|||mixed model for repeated measures||FS MDPI / ADVAIR DISKUS|High-strength comparison||0.150|-0.032|0.2056
70992740|NCT02232087|141493455|EQUIVALENCE|The potency of the test and reference product was considered equivalent if the 90% CI for the estimate of relative potency was completely contained within the limits of 0.67 to 1.50|Odds Ratio, log|1.0|||>|0.1|TWO_SIDED|90.0|0.67|1.5||test for parallelism of dose response lines|ANOVA||Test is the numerator|The measurement of relative potency was conducted for the pair of doses which met the above criteria and lay on the steepest linear portion of the dose response curve. The log estimate of relative potency was obtained as the ratio of the estimated treatment effect as measured by the difference in the intercepts of the parallel lines divided by the estimate of the common slope for log dose.||1.50|0.67|>0.10
70992741|NCT02232087|141493456|EQUIVALENCE|The potency of the test and reference product was considered equivalent if the 90% CI for the estimate of relative potency was completely contained within the limits of 0.67 to 1.50|Odds Ratio, log|1.0|||>|0.1|TWO_SIDED|90.0|0.67|1.5||test for parallelism of dose response lines|ANOVA||Test is the numerator|The measurement of relative potency was conducted for the pair of doses which met the above criteria and lay on the steepest linear portion of the dose response curve. The log estimate of relative potency was obtained as the ratio of the estimated treatment effect as measured by the difference in the intercepts of the parallel lines divided by the estimate of the common slope for log dose.||1.50|0.67|>0.10
70992742|NCT02232087|141493457|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.55|TWO_SIDED|95.0|-2.5|1.4||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||1.4|-2.5|0.55
70992743|NCT02232087|141493457|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|1.0||||0.53|TWO_SIDED|95.0|-2.5|1.3||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||1.3|-2.5|0.53
70992744|NCT02232087|141493457|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|1.0||||0.011|TWO_SIDED|95.0|-2.5|1.3||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||1.3|-2.5|0.011
70992745|NCT02232087|141493458|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.26|TWO_SIDED|95.0|-0.03|0.1||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||0.10|-0.03|0.26
70992746|NCT02232087|141493458|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.93|TWO_SIDED|95.0|-0.06|0.06||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||0.06|-0.06|0.93
70992747|NCT02232087|141493458|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.48|TWO_SIDED|95.0|-0.04|0.08||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||0.08|-0.04|0.48
71039585|NCT02959840|141587079|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||1|||||||Chi-squared|||||||1
70923357|NCT05343390|141338047|SUPERIORITY||Rate Ratio|1.22||||0.14|TWO_SIDED|95.0|0.93|1.6|||Mixed Models Analysis|Negative binomial mixed-effect model||||1.60|0.93|0.14
70923358|NCT05343390|141338048|SUPERIORITY||Rate Ratio|1.37||||0.006|TWO_SIDED|95.0|1.1|1.71|||Mixed Models Analysis|Negative binomial mixed-effect model||||1.71|1.10|0.006
70992748|NCT02232087|141493459|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.93|TWO_SIDED|95.0||||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||||0.93
71039586|NCT02959840|141587079|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.2|||||||Chi-squared|||||||0.2
71039587|NCT02959840|141587079|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.1|||||||Chi-squared|||||||0.1
71039588|NCT02959840|141587080|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.001|||||||Chi-squared|||||||0.001
71039589|NCT02959840|141587080|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.0004|||||||Chi-squared|||||||0.0004
71039590|NCT02959840|141587080|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||1|||||||Chi-squared|||||||1
71039591|NCT02959840|141587081|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.008|||||||Chi-squared|||||||0.008
71099024|NCT04641975|141706800|SUPERIORITY||Mean Difference (Final Values)|2.58|STANDARD_ERROR_OF_MEAN|31.08||0.935|TWO_SIDED|90.0|-53.23|58.38|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 with LOCF as response, treatment group, sex and geographical region as fixed effects and the mean volume voided per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||58.38|-53.23|0.935
71099025|NCT04641975|141706801|SUPERIORITY||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.53||0.073|TWO_SIDED|90.0|-1.99|-0.1|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 without LOCF as response, treatment group, sex and geographical region as fixed effects and the mean volume voided per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||-0.10|-1.99|0.073
70992749|NCT02232087|141493459|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.42|TWO_SIDED|95.0|-0.224|0.093||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||0.093|-0.224|0.42
71039592|NCT02959840|141587081|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.07|||||||Chi-squared|||||||0.07
71039593|NCT02959840|141587081|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.6|||||||Chi-squared|||||||0.6
71039594|NCT02959840|141587082|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.2|||||||Chi-squared|||||||0.2
71039595|NCT02959840|141587082|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.5|||||||Chi-squared|||||||0.5
71039596|NCT02959840|141587082|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.7|||||||Chi-squared|||||||0.7
71039597|NCT02959840|141587083|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.5|||||||Chi-squared|||||||0.5
71039598|NCT02959840|141587083|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||1|||||||Chi-squared|||||||1
71039599|NCT02959840|141587083|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.5|||||||Chi-squared|||||||0.5
71039600|NCT02959840|141587084|SUPERIORITY|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.02|||||||Fisher Exact|||||||0.02
71039601|NCT02959840|141587084|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.2|||||||Fisher Exact|||||||0.2
71039602|NCT02959840|141587084|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.3|||||||Fisher Exact|||||||0.3
71039603|NCT02959840|141587085|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.2|||||||Fisher Exact|||||||0.2
71039604|NCT02959840|141587085|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.5|||||||Fisher Exact|||||||0.5
71039605|NCT02959840|141587085|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.7|||||||Fisher Exact|||||||0.7
71099026|NCT04641975|141706801|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.45||0.044|TWO_SIDED|90.0|-1.8|-0.2|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 with LOCF as response, treatment group, sex and geographical region as fixed effects and the mean volume voided per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||-0.20|-1.80|0.044
70992750|NCT02232087|141493459|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.078|TWO_SIDED|95.0|-0.302|0.016||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||0.016|-0.302|0.078
70992751|NCT02232087|141493460|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.71|TWO_SIDED|95.0|-3.9|5.7||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||5.7|-3.9|0.71
70992752|NCT02232087|141493460|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-4.7|4.7||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||4.7|-4.7|1.00
70992753|NCT02232087|141493460|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|-2.0||||0.016|TWO_SIDED|95.0|-10.6|-1.1||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||-1.1|-10.6|0.016
70992754|NCT02504268|141493462|SUPERIORITY|||||||0.2359|||||||Regression, Logistic|||||||0.2359
70992755|NCT02504268|141493463|SUPERIORITY|||||||0.0112|||||||Regression, Logistic|||||||0.0112
70992756|NCT02504268|141493464|SUPERIORITY|||||||0.0021|||||||Regression, Logistic|||||||0.0021
70992757|NCT02504268|141493465|SUPERIORITY||||||<|0.0001|||||||rank-based ANCOVA|||||||< 0.0001
70992758|NCT02504268|141493466|SUPERIORITY|||||||0.0006|||||||Regression, Logistic|||||||0.0006
70992759|NCT02108600|141493470|OTHER|||||||0.033|TWO_SIDED|95.0|||||Fisher Exact|||||||0.033
70992760|NCT01580592|141493579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.6|STANDARD_DEVIATION|7.6||0.001|TWO_SIDED||||||ANOVA||for omalizumab 150mg|||||0.001
70992761|NCT01580592|141493579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.4|STANDARD_DEVIATION|9.4||0.01|TWO_SIDED||||||ANOVA|||||||0.01
70992762|NCT01580592|141493579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|3.9|||TWO_SIDED|||||||||||||
70992763|NCT01580592|141493580|SUPERIORITY_OR_OTHER|||||||0.988|||||||Chi-squared|||||||0.988
70992764|NCT03471767|141493587|SUPERIORITY|Multilevel modeling (MLM) was used to model daily reports of cigarettes smoked as a function of week, treatment (AXS-05 vs. bupropion), and the interaction between week and treatment. The contrast between the two treatment groups in change in smoking intensity from baseline to week 3 was estimated within the context of the model.|Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.54||0.05|TWO_SIDED|95.0|-2.75|-0.65||This was not adjusted for multiple comparisons, because the primary hypothesis was established a-priori.|t-test, 2 sided|||||-0.65|-2.75|0.05
70992765|NCT03471767|141493593|OTHER|||||||0.15|||||||t-test, 2 sided|||||||0.15
70992766|NCT00678587|141493594|SUPERIORITY_OR_OTHER||Absolute difference in proportions|52.8|||<|0.0001|TWO_SIDED|95.0|43.2|62.4|||Cochran-Mantel-Haenszel|||||62.4|43.2|<0.0001
70992767|NCT00678587|141493595|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-5.9|||||TWO_SIDED|95.0|-15.1|3.3||||||||3.3|-15.1|
70992768|NCT00678587|141493596|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71099027|NCT04641975|141706802|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.39||0.91|TWO_SIDED|90.0|-0.74|0.64|||ANCOVA|||ANCOVA as performed with change from baseline at week 12 without LOCF as response, treatment group, sex and geographical region as fixed effects and the mean number of daytime incontinence episodes per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||0.64|-0.74|0.910
70992769|NCT00305253|141493628|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.38||||0.019|TWO_SIDED|95.0|0.17|0.85|||Regression, Logistic|Independent variables were selected on the basis of their significant association with EAO in bivariate analyses (t-tests and logistic regression).|Pre-Intervention group was compared to the Post-Intervention group. Each group contained different study participants.|"Relative risks and confidence intervals were computed for the primary outcome, Extreme Adverse Outcomes (EAO) - a combined measure of maternal mortality or severe mobidity.~To estimate the independent effect of the intervention net of the effects of other baseline characteristics, a multiple logistic regression model was used."||0.85|0.17|0.019
70992770|NCT00305253|141493629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.79|||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided||Pre-Intervention group was compared to the Post-Intervention group. Each group contained different study participants.|Mean measured volume of blood loss in the drape was compared across phases with t-tests.||||<0.0001
70992771|NCT00305253|141493630|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.41|||<|0.05|TWO_SIDED|95.0|0.21|0.8|||t-test, 2 sided||Pre-Intervention group was compared to the Post-Intervention group. Each group contained different study participants.|Relative risks and confidence intervals were computed for emergency hysterectomy.||0.80|0.21|<0.05
70992772|NCT01606761|141493643|SUPERIORITY_OR_OTHER||Percentage Difference|15.9|||<|0.001|TWO_SIDED|95.0|8.5|23.2|||Cochran-Mantel-Haenszel|||||23.2|8.5|< 0.001
70992773|NCT01606761|141493643|SUPERIORITY_OR_OTHER||Percentage Difference|21.0|||<|0.001|TWO_SIDED|95.0|13.6|28.5|||Cochran-Mantel-Haenszel|||||28.5|13.6|< 0.001
71039606|NCT00856349|141587219|SUPERIORITY_OR_OTHER||Increase in % on target (LIA)|13.6|||<|0.0001|||||||McNemar|||LIA (Lead Integrity Alert): Uploadable algorithm with the ability to increase the time between a lead fracture and potential delivery of an unnecessary shock.||||<0.0001
70992774|NCT01606761|141493644|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.17|||<|0.001|TWO_SIDED|95.0|-0.251|-0.088|||ANCOVA|||||-0.088|-0.251|< 0.001
70992775|NCT01606761|141493644|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.194|||<|0.001|TWO_SIDED|95.0|-0.275|-0.112|||ANCOVA|||||-0.112|-0.275|< 0.001
70992776|NCT01606761|141493645|SUPERIORITY_OR_OTHER||Percentage Difference|12.0|||<|0.001|TWO_SIDED|95.0|6.4|17.7|||Cochran-Mantel-Haenszel|||||17.7|6.4|< 0.001
70992777|NCT01606761|141493645|SUPERIORITY_OR_OTHER||Percentage Difference|12.7|||<|0.001|TWO_SIDED|95.0|7.0|18.4|||Cochran-Mantel-Haenszel|||||18.4|7.0|< 0.001
70992778|NCT01606761|141493646|SUPERIORITY_OR_OTHER||Percentage Difference|11.0|||<|0.001|TWO_SIDED|95.0|5.5|16.5|||Cochran-Mantel-Haenszel|||||16.5|5.5|< 0.001
70992779|NCT01606761|141493646|SUPERIORITY_OR_OTHER||Percentage Difference|13.4|||<|0.001|TWO_SIDED|95.0|7.8|19.1|||Cochran-Mantel-Haenszel|||||19.1|7.8|< 0.001
70992780|NCT05086289|141493647|SUPERIORITY||Posterior Mean Difference|-0.38|||||TWO_SIDED|95.0|-0.89|0.13|||||Posterior mean difference with 95% credible interval is reported.|||0.13|-0.89|
70992781|NCT05086289|141493648|SUPERIORITY||Posterior Mean Difference|-0.28|||||TWO_SIDED|95.0|-0.85|0.3|||||Posterior mean difference with 95% credible interval is reported.|||0.30|-0.85|
70992782|NCT05086289|141493649|SUPERIORITY||Posterior Mean Difference|-0.62|||||TWO_SIDED|95.0|-1.91|0.68|||||Posterior mean difference with 95% credible interval is reported.|||0.68|-1.91|
70992783|NCT05086289|141493650|SUPERIORITY||Posterior Mean Difference|-1.17|||||TWO_SIDED|95.0|-2.54|0.18|||||Posterior mean difference with 95% credible interval is reported.|||0.18|-2.54|
70992784|NCT05086289|141493651|SUPERIORITY||Posterior Mean Difference|-0.12|||||TWO_SIDED|95.0|-0.44|0.19|||||Posterior mean difference with 95% credible interval is reported.|||0.19|-0.44|
70992785|NCT05086289|141493652|SUPERIORITY||Posterior Mean Difference|-0.26|||||TWO_SIDED|95.0|-0.67|0.14|||||Posterior mean difference with 95% credible interval is reported.|||0.14|-0.67|
70992786|NCT05086289|141493653|SUPERIORITY||Posterior Mean Difference|-0.48|||||TWO_SIDED|95.0|-1.05|0.09|||||Posterior mean difference with 95% credible interval is reported.|||0.09|-1.05|
70992787|NCT05086289|141493654|SUPERIORITY||Posterior Mean Difference|-0.51|||||TWO_SIDED|95.0|-1.17|0.16|||||Posterior mean difference with 95% credible interval is reported.|||0.16|-1.17|
70992788|NCT05086289|141493655|SUPERIORITY||Posterior Mean Difference|-4.95|||||TWO_SIDED|95.0|-11.07|1.27|||||Posterior mean difference with 95% credible interval is reported.|||1.27|-11.07|
70992789|NCT05086289|141493656|SUPERIORITY||Posterior Mean Difference|-4.78|||||TWO_SIDED|95.0|-11.73|2.15|||||Posterior mean difference with 95% credible interval is reported.|||2.15|-11.73|
70992790|NCT05086289|141493657|SUPERIORITY||Posterior Mean Difference|-0.13|||||TWO_SIDED|95.0|-0.46|0.21|||||Posterior mean difference with 95% credible interval is reported.|||0.21|-0.46|
70992791|NCT05086289|141493658|SUPERIORITY||Posterior Mean Difference|1.52|||||TWO_SIDED|95.0|-6.2|9.2|||||Posterior mean difference with 95% credible interval is reported.|||9.20|-6.20|
70992792|NCT05086289|141493659|SUPERIORITY||Posterior Mean Difference|0.0|||||TWO_SIDED|95.0|-0.06|0.07|||||Posterior mean difference with 95% credible interval is reported.|||0.07|-0.06|
70992793|NCT05086289|141493660|SUPERIORITY||Posterior Mean Difference|0.02|||||TWO_SIDED|95.0|-0.05|0.1|||||Posterior mean difference with 95% credible interval is reported.|||0.10|-0.05|
70992794|NCT05086289|141493661|SUPERIORITY||Posterior Mean Difference|41.72|||||TWO_SIDED|95.0|-95.92|179.76|||||Posterior mean difference with 95% credible interval is reported.|||179.76|-95.92|
71039607|NCT00856349|141587219|SUPERIORITY_OR_OTHER||Increase in % on target (SVT Limit)|6.8|||<|0.0001|||||||McNemar|||SVT (Supraventricular Tachycardia) Limit: The maximum cycle length that Wavelet and PR logic will be applied to arrhythmias.||||<0.0001
71039608|NCT00856349|141587219|SUPERIORITY_OR_OTHER||Increase in % on target (VF NID PP)|9.0|||<|0.0001|||||||McNemar|||VF NID PP: Number of intervals to detect (NID) an arrhythmia in the VF zone for primary prevention (PP) patients.||||<0.0001
70992795|NCT05086289|141493662|SUPERIORITY||Posterior Mean Difference|9.73|||||TWO_SIDED|95.0|-151.11|170.52|||||Posterior mean difference with 95% credible interval is reported.|||170.52|-151.11|
70992796|NCT02130258|141493671|OTHER|||||||0.04|||||||Kruskal-Wallis|||||||.04
70992797|NCT02130258|141493672|OTHER|||||||0.04|||||||Kruskal-Wallis|||||||.04
70992798|NCT02130258|141493673|OTHER|||||||0.04|||||||Kruskal-Wallis|||||||0.04
71039609|NCT00856349|141587219|SUPERIORITY_OR_OTHER||Increase in % on target (VF NID SP)|3.5||||0.0116|||||||McNemar|||VF NID SP: Number of intervals to detect (NID) an arrhythmia in the VF zone for secondary prevention (SP) patients.||||0.0116
70992799|NCT03150108|141493674|EQUIVALENCE|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed Cmax values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% confidence interval (CI).|Geometric mean ratio|1.119|||||TWO_SIDED|90.0|0.875|1.43||||||||1.430|0.875|
71039610|NCT00856349|141587219|SUPERIORITY_OR_OTHER||Increase in % on target (Wavelet)|9.5|||<|0.0001|||||||McNemar|||Wavelet: Discriminator to help determine if arrhythmia is ventricular or supraventricular in single chamber ICDs.||||<0.0001
70992800|NCT03150108|141493674|OTHER|Dose proportionality|Increase in Cmax per Dose Doubling|1.76|||||TWO_SIDED|90.0|1.52|2.03|||||Linear model of log transformed PK parameters at all doses in Japanese descent, including log transformed dose, period, sequence as fixed effects, and intercept as a random effect accounting for each participant within sequence as their own control.|Dose proportionality was assessed for baseline-adjusted Cmax using the power model. The power model assumes a linear relationship between the natural log transformed parameter and the natural log transformed dose. The fold increase in PK parameters with doubling the dose and the 90% CIs were calculated.||2.03|1.52|
70992801|NCT03150108|141493676|EQUIVALENCE|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed AUClast values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% CI.|Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.8|1.23||||||||1.23|0.80|
70992802|NCT03150108|141493676|OTHER|Dose proportionality|Increase in AUClast per Dose Doubling|2.35||||||90.0|2.06|2.7|||||Linear model of log transformed PK parameters at all doses in Japanese descent, including log transformed dose, period, sequence as fixed effects, and intercept as a random effect accounting for each participant within sequence as their own control.|Dose proportionality was assessed for baseline-adjusted AUClast using the power model. The power model assumes a linear relationship between the natural log transformed parameter and the natural log transformed dose. The fold increase in PK parameters with doubling the dose and the 90% CIs were calculated.||2.70|2.06|
70992803|NCT03150108|141493677|EQUIVALENCE|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed AUC0-8 values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% CI.|Geometric mean ratio|1.08|||||TWO_SIDED|90.0|0.87|1.35||||||||1.35|0.87|
71039611|NCT00856349|141587219|SUPERIORITY_OR_OTHER||Increase in % on target (PR Logic)|3.2|||<|0.0001|||||||McNemar|||PR Logic: Discriminator to help determine if arrhythmia is ventricular or supraventricular in dual chamber ICDs and CRT-Ds.||||<0.0001
71039612|NCT05061992|141587225|SUPERIORITY|||||||0.6|||||||ANCOVA|||Change in SF-8||||0.6
71039613|NCT05061992|141587225|SUPERIORITY|||||||0.2|||||||ANCOVA|||End of trial SF-8||||0.2
71039614|NCT05061992|141587226|SUPERIORITY|||||||0.001|||||||ANCOVA|||Change in ANT||||0.001
71039615|NCT05061992|141587226|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||End of trial ANT||||0.09
71039616|NCT05061992|141587227|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
71039617|NCT05061992|141587228|SUPERIORITY|||||||0.02|||||||ANCOVA|||||||0.02
71039618|NCT05061992|141587229|SUPERIORITY|||||||0.6|||||||Fisher Exact|||||||0.6
71039619|NCT05061992|141587230|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.2
71039620|NCT01157234|141587231|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|28.73|||||TWO_SIDED|95.0|1.93|55.53||||||||55.53|1.93|
71039621|NCT01157234|141587232|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|8.27|||||TWO_SIDED|95.0|-12.58|29.12||||||||29.12|-12.58|
71039622|NCT01157234|141587233|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.23|STANDARD_ERROR_OF_MEAN|3.87|||TWO_SIDED|95.0|-6.74|9.2||||||||9.20|-6.74|
71039623|NCT01157234|141587237|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|11.94|||||TWO_SIDED|95.0|0.48|23.4||||||||23.40|0.48|
71039624|NCT01157234|141587238|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|69.54|STANDARD_ERROR_OF_MEAN|19.83|||TWO_SIDED|99.7|12.71|126.37||||||||126.37|12.71|
71039625|NCT01157234|141587239|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|68.19|STANDARD_ERROR_OF_MEAN|19.24|||TWO_SIDED|99.17|13.02|123.36||||||||123.36|13.02|
71039626|NCT01157234|141587240|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.39|STANDARD_ERROR_OF_MEAN|17.32|||TWO_SIDED|99.17|-48.25|51.03||||||||51.03|-48.25|
71039627|NCT01157234|141587241|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|2.74|STANDARD_ERROR_OF_MEAN|17.96|||TWO_SIDED|99.17|-48.74|54.22||||||||54.22|-48.74|
71039628|NCT02542462|141587252|SUPERIORITY|||||||0.2||||||P value for the number of subjects with an increase of 1 mm or more of terminal ileum from pre to post was 0.2|Fisher Exact|||The test is to see a difference among the four groups and the pre to post change of the primary outcomes||||0.2
71039629|NCT02542462|141587252|SUPERIORITY|||||||0.3||||||P value for change in the number of subjects with an increase in number of lymph nodes from pre to post was 0.3.|Fisher Exact|||The test is to see a difference among the four groups and the pre to post change of the primary outcomes||||0.3
71039630|NCT01717313|141587275|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.39|||<|0.001|TWO_SIDED|95.0|-0.59|-0.19|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior antihyperglycemic agent (AHA) therapy status, interaction of time by treatment, and time by prior AHA therapy status||||-0.19|-0.59|<0.001
71039631|NCT01717313|141587276|SUPERIORITY_OR_OTHER||Differences in percentages vs. placebo|-8.2|||||TWO_SIDED|95.0|-18.8|2.6||||||||2.6|-18.8|
71039632|NCT01717313|141587277|SUPERIORITY_OR_OTHER||Difference in percentages vs. placebo|0.6|||||TWO_SIDED|95.0|-3.1|4.5||||||||4.5|-3.1|
71039633|NCT01717313|141587278|SUPERIORITY_OR_OTHER||Difference in percentages vs. placebo|-5.8|||||TWO_SIDED|95.0|-16.4|4.9||||||||4.9|-16.4|
71039634|NCT01717313|141587279|SUPERIORITY_OR_OTHER||Difference in percentages vs. placebo|0.6|||||TWO_SIDED|95.0|-3.5|4.8||||||||4.8|-3.5|
71039635|NCT01717313|141587280|SUPERIORITY_OR_OTHER||Between-group rate difference|20.3|||<|0.001|TWO_SIDED|95.0|10.5|29.8|||Miettinen & Nurminen method|||||29.8|10.5|<0.001
71039636|NCT01717313|141587281|SUPERIORITY_OR_OTHER||Between-group rate difference|11.4||||0.001|TWO_SIDED|95.0|4.8|18.6|||Miettinen & Nurminen method|||||18.6|4.8|0.001
71039637|NCT01717313|141587282|SUPERIORITY_OR_OTHER||Difference in the least squares means|-10.3||||0.036|TWO_SIDED|95.0|-19.9|-0.7|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior AHA therapy status, the interaction of time by treatment, and time by prior AHA therapy status||||-0.7|-19.9|0.036
71039638|NCT01717313|141587283|SUPERIORITY_OR_OTHER||Difference in the least squares means|-11.6||||0.177|TWO_SIDED|95.0|-28.6|5.3|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior AHA therapy status, the interaction of time by treatment, and time by prior AHA therapy status||||5.3|-28.6|0.177
71039639|NCT01717313|141587288|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.53|||<|0.001|TWO_SIDED|95.0|-0.75|-0.32|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior AHA therapy status, the interaction of time by treatment, and time by prior AHA therapy status||||-0.32|-0.75|<0.001
70992804|NCT03150108|141493677|OTHER|Dose proportionality|Increase in AUC0-8 per Dose Doubling|2.23|||||TWO_SIDED|90.0|1.98|2.51|||||Linear model of log transformed PK parameters at all doses in Japanese descent, including log transformed dose, period, sequence as fixed effects, and intercept as a random effect accounting for each participant within sequence as their own control.|Dose proportionality was assessed for baseline-adjusted AUC0-8 using the power model. The power model assumes a linear relationship between the natural log transformed parameter and the natural log transformed dose. The fold increase in PK parameters with doubling the dose and the 90% CIs were calculated.||2.51|1.98|
70992805|NCT03150108|141493678|EQUIVALENCE|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed AUC0-inf values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% CI.|Geometric mean ratio|1.01|||||TWO_SIDED|90.0|0.77|1.33||||||||1.33|0.77|
70992806|NCT03150108|141493678|OTHER|Dose proportionality|Increase in AUC0-inf per Dose Doubling|2.31|||||TWO_SIDED|90.0|1.96|2.71|||||Linear model of log transformed PK parameters at all doses in Japanese descent, including log transformed dose, period, sequence as fixed effects, and intercept as a random effect accounting for each participant within sequence as their own control.|Dose proportionality was assessed for baseline-adjusted AUC0-inf using the power model. The power model assumes a linear relationship between the natural log transformed parameter and the natural log transformed dose. The fold increase in PK parameters with doubling the dose and the 90% CIs were calculated.||2.71|1.96|
70992807|NCT03150108|141493684|EQUIVALENCE|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed Cmax values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% CI.|Geometric Mean Ratio|1.13|||||TWO_SIDED|90.0|0.9|1.4||||||||1.40|0.90|
70992808|NCT03150108|141493686|EQUIVALENCE|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed Cmax values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% CI.|Geometric Mean Ratio|1.08|||||TWO_SIDED|90.0|0.93|1.25||||||||1.25|0.93|
70992809|NCT01975935|141493695|SUPERIORITY|||||||0.05||||||This is the calculated p value and not the threshold for statistical significance.|t-test, 2 sided|||||||0.05
70992810|NCT01975935|141493696|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
70992811|NCT01975935|141493697|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.51
70992812|NCT00807846|141493704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1||||0.274|TWO_SIDED|90.0|-0.56|2.76|||ANCOVA|||The primary analysis was based on 90% confidence interval (CI) for the difference across treatment groups (celecoxib - naproxen) in mean change from baseline in SBP. Change from Baseline in BP was analyzed using analysis of covariance (ANCOVA) with model terms for treatment with baseline height, baseline weight, baseline age, and baseline SBP as covariates. No formal hypothesis testing was applied to the primary analysis.||2.76|-0.56|0.274
71039640|NCT01717313|141587289|SUPERIORITY_OR_OTHER||Difference in the least squares means|-13.2||||0.014|TWO_SIDED|95.0|-23.7|-2.7|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior AHA therapy status, the interaction of time by treatment, and time by prior AHA therapy status||||-2.7|-23.7|0.014
71039641|NCT01717313|141587290|SUPERIORITY_OR_OTHER||Difference in the least squares means|-20.5||||0.031|TWO_SIDED|95.0|-39.0|-1.9|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior AHA therapy status, the interaction of time by treatment, and time by prior AHA therapy status||||-1.9|-39.0|0.031
71039642|NCT00835588|141587293|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|88.8||||||90.0|82.7|95.4|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||95.4|82.7|
71039643|NCT00835588|141587294|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|97.3||||||90.0|93.4|101.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101|93.4|
71039644|NCT00835588|141587295|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|95.6||||||90.0|91.6|99.8|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.8|91.6|
71039645|NCT00354159|141587318|SUPERIORITY_OR_OTHER||6-month survival rate|90.5|||<|0.001|ONE_SIDED|97.5|87.7|||The survival estimate at 6-months post-implant was compared to 80%. The comparison was made using the cumulative hazard \[e.g. log survival estimate\] for the variance.|Survival estimate at 6-months|The survival estimate at 6-months post-implant was compared to 80%.||"Null hypothesis: Freedom from Chronicle system-related complications at 6-months post-implant is less than or equal to 80%.~Alternative hypothesis: Freedom from Chronicle system-related complications at 6-months is greater than 80%."|||87.7|<0.001
71039646|NCT00354159|141587320|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.978|TWO_SIDED|95.0|0.61|1.61||The P-value is from the Andersen-Gill model, an extension of the Cox proportional hazards model for multiple events.|Andersen-Gill||Hazard Ratio is for the Treatment Arm relative to the Control Arm.|"The study was originally powered at 80% to detect a 25% risk reduction between the treatment arm and control arm with a type I error rate of 0.05. Under these assumptions 648 HF-related events from approximately 1300 subjects were required. The study stopped after 400 were randomized.~Null Hypothesis: The HF-related event rate is the same between the treatment arm and control arm.~Alternative Hypothesis: The HF-related event rate between the treatment arm and control arm is different."||1.61|0.61|0.978
71039647|NCT00354159|141587321|SUPERIORITY_OR_OTHER|||||||0.574||95.0|||||Wilcoxon (Mann-Whitney)|||"Null Hypothesis: mu(Treatment) = mu(Control) Alternative Hypothesis: mu(Treatment) ne mu(Control)~where mu is the percentage of hospitalized days for heart failure."||||0.574
71039648|NCT00354159|141587322|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.527|TWO_SIDED|95.0|0.62|1.28||The P-value is from the Andersen-Gill model, an extension of the Cox proportional hazards model for multiple events.|Andersen-Gill Model||Hazard Ratio is for the Treatment Arm relative to the Control Arm.|"Null Hypothesis: The CV-related event rate is the same between the treatment arm and control arm.~Alternative Hypothesis: The CV-related event rate between the treatment arm and control arm is different."||1.28|0.62|0.527
71039649|NCT00354159|141587323|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.505|TWO_SIDED|95.0|0.57|1.32|||Regression, Cox|The treatment and control hazard ratio and 95% confidence interval was estimated using a univariate cox Regression Model.|Hazard Ratio is for the Treatment Arm relative to the Control Arm|"Null Hypothesis: Freedom from death or HF-related hospitalization is the same between the treatment arm and the control arm.~Alternative Hypothesis: Freedom from death or HF-related hospitalization is different between the treatment arm and the control arm."||1.32|0.57|0.505
71039650|NCT00354159|141587324|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.088|TWO_SIDED|95.0|0.56|1.04|||Andersen-Gill Model|The P-value is from the Andersen-Gill model, an extension of the Cox proportional hazards model for multiple events.|Hazard Ratio is for the Treatment Arm relative to the Control Arm.|"Null Hypothesis: The all cause event rate is the same between the treatment arm and control arm.~Alternative Hypothesis: The all cause event rate between the treatment arm and control arm is different."||1.04|0.56|0.088
71039651|NCT00354159|141587325|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.758|TWO_SIDED|95.0|0.73|1.54||P-value is from a proportional odds model comparing the distribution of composite endpoint response between the treatment arm and control arm.|Proportional odds model||Odds ratio represents the odds of improved score in the treatment group relative to the control group.|"Null Hypothesis: Distribution of composite response endpoint is the same between the treatment arm and the control arm.~Alternative Hypothesis: Distribution of composite response endpoint is different between the treatment arm and the control arm."||1.54|0.73|0.758
71039652|NCT00354159|141587328|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.599|TWO_SIDED|95.0|0.29|2.06|||Regression, Cox|The treatment to control hazard ratio and 95% confidence interval was estimated using a univariate Cox Regression Model|Hazard ratio estimates the hazard of death in the treatment group relative to the control group.|"Null hypothesis: Survival during the 12-month randomized follow-up period is the same between the treatment and control groups.~Alternative hypothesis: Survival during the 12-month randomized period is different between the treatment and control groups."||2.06|0.29|0.599
71039653|NCT00354159|141587329|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||Negative-Binomial Regression|||The null hypothesis is that the rate of cardiovascular medication changes is the same between the Treatment Arm and Control Arm.||||0.145
71039654|NCT00354159|141587330|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||t-test, 2 sided|||"Null hypothesis: Average daily median ePAD is the same between the Treatment and Control arms.~Alternative hypothesis: Average daily median ePAD is the different between the Treatment and Control arms."||||0.033
71039655|NCT00354159|141587331|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||"Null Hypothesis: The average daily median ePAD is not different among Control Arm subjects that have and that do not have a heart failure related event during the 12-month follow-up period.~Alternative Hypothesis: The average daily median ePAD is different among Control Arm subjects that have and that do not have a heart failure related event during the 12-month follow-up period."||||0.002
71099028|NCT04641975|141706802|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.39||0.91|TWO_SIDED|90.0|-0.74|0.64|||ANCOVA|||ANCOVA as performed with change from baseline at week 12 with LOCF as response, treatment group, sex and geographical region as fixed effects and the mean number of daytime incontinence episodes per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||0.64|-0.74|0.910
70992813|NCT00807846|141493705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.088||||0.148|TWO_SIDED|95.0|-0.39|2.57|||ANCOVA|||For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.||2.57|-0.39|0.148
70992814|NCT00807846|141493706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.837||||0.027|TWO_SIDED|95.0|0.21|3.46|||ANCOVA|||"For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in blood pressure was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates.~Secondary analyses were conducted using a two-sided test with α=0.05."||3.46|0.21|0.027
71099029|NCT04641975|141706803|SUPERIORITY||Mean Difference (Final Values)|2.48|STANDARD_ERROR_OF_MEAN|0.85||0.012|TWO_SIDED|90.0|0.97|3.99|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 without LOCF as response, treatment group, sex and geographical region as fixed effects and the mean number of daytime micturitions per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||3.99|0.97|0.012
71099030|NCT04641975|141706803|SUPERIORITY||Mean Difference (Final Values)|2.46|STANDARD_ERROR_OF_MEAN|0.77||0.007|TWO_SIDED|90.0|1.1|3.82|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 with LOCF as response, treatment group, sex and geographical region as fixed effects and the mean number of daytime micturitions per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||3.82|1.10|0.007
71099031|NCT04641975|141706804|SUPERIORITY||Rate ratio|0.2||||0.105|TWO_SIDED|90.0|0.04|1.02|||Binomial regression|||Without LOCF: From a negative binomial regression model including treatment group, sex and region as factors and the log baseline rate of number of dry days (the log of the ratio of dry days at baseline and number of diary days at baseline) as covariate.||1.02|0.04|0.105
71099032|NCT04641975|141706804|SUPERIORITY||Rate ratio|0.22||||0.111|TWO_SIDED|90.0|0.05|1.05|||Binomial regression|||With LOCF: From a negative binomial regression model including treatment group, sex and region as factors and the log baseline rate of number of dry days (the log of the ratio of dry days at baseline and number of diary days at baseline) as covariate.||1.05|0.05|0.111
70992815|NCT00807846|141493707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.207||||0.106|TWO_SIDED|95.0|-2.67|0.26|||ANCOVA|||For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.||0.26|-2.67|0.106
70992816|NCT00807846|141493708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22||||0.776|TWO_SIDED|95.0|-1.3|1.74|||ANCOVA|||For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.||1.74|-1.30|0.776
70992817|NCT00807846|141493709|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.179||||0.815|TWO_SIDED|95.0|-1.69|1.33|||ANCOVA|||For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline blood pressure as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.||1.33|-1.69|0.815
70992818|NCT00807846|141493710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.033||||0.303|TWO_SIDED|95.0|-2.76|8.82|||ANCOVA|||Change from Baseline to Week 6 was analyzed using ANCOVA model as well with treatment and Baseline value as a covariate. The LS mean change from Baseline was compared between treatment groups and an appropriate p-value and 95% CI for the difference between the two treatment groups was generated. This analysis was conducted using a two-sided test with α=0.05.||8.82|-2.76|0.303
70992819|NCT00807846|141493711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.061||||0.392|TWO_SIDED|95.0|-0.202|0.079|||Chi-squared||Mean Difference (Final Values) indicates difference in incidence (proportion) between treatments.|The number of subjects with at least a 30% improvement in Parent/Guardian's Global Assessment of Overall Well-Being was compared between the two treatment groups using a chi-square test. A 95% CI for the difference in incidence between groups was also computed.||0.079|-0.202|0.392
71099033|NCT05287685|141706839|OTHER|||||||0.29|||||||t-test, 2 sided|||Preliminary pre-post outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline (week 0) to posttest (week 8) scores.||||.29
71099034|NCT05287685|141706839|OTHER|||||||0.34|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline(week 0) to follow-up (week 16) scores.||||.34
71099035|NCT05287685|141706839|SUPERIORITY|||||||0.02|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at posttest (Week 8) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.02
71099036|NCT05287685|141706839|SUPERIORITY|||||||0.04|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at follow-up (Week 16) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.04
71099037|NCT05287685|141706840|OTHER|||||||0.88|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline (week 0) to posttest (week 8) scores.||||.88
70992820|NCT00807846|141493712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.402||||0.897|TWO_SIDED|95.0|-6.5|5.69|||ANCOVA|||Change from Baseline to Week 6 was analyzed using ANCOVA model as well with treatment and Baseline value as a covariate. The LS mean change from Baseline was compared between treatment groups and an appropriate p-value and 95% CI for the difference between the two treatment groups was generated. This analysis was conducted using a two-sided test with α=0.05.||5.69|-6.50|0.897
70992821|NCT00807846|141493713|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.102||||0.2|TWO_SIDED|95.0|-0.257|0.053|||Chi-squared||Mean Difference (Final Values) indicates difference in incidence (proportion) between treatments.|The number of participants with at least a 30% improvement in participant's Global Assessment of Overall Well-Being was compared between the two treatment groups using a chi-square test. A 95% CI for the difference in incidence between groups was also computed.||0.053|-0.257|0.200
70992822|NCT02491073|141493743|OTHER||geometric mean ratio|1.05||||1.05|TWO_SIDED|90.0|0.98|1.09|||geometric mean ration||The parameter dispersion type:Geometric coefficient of variation Dispersion Value: FT4: 0.220|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator.|1.09|0.98|1.05
71039656|NCT00354159|141587332|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.292|TWO_SIDED|95.0|0.82|1.96|||Proportional odds regression model||Direction for odds ratio is the odds of improvement in the Treatment arm versus the odds of improvement in the Control arm.|"Null Hypothesis: There is no difference in the change in NYHA functional class between the Treatment and Control Arms.~Alternative Hypothesis: There is a difference in the change in NYHA functional class between the Treatment and Control Arms."||1.96|0.82|0.292
71039657|NCT00354159|141587333|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||Mixed Models Analysis|||"Null Hypothesis: The change in 6-minute hall walk distance is not different between the Treatment and Control Arms.~Alternative Hypothesis: The change in 6-minute hall walk distance is different between the Treatment and Control Arms."||||0.996
70923359|NCT05343390|141338049|SUPERIORITY||Rate Ratio|2.29||||0.013|TWO_SIDED|95.0|1.19|4.4|||Mixed Models Analysis|Negative binomial mixed-effect model||||4.40|1.19|0.013
70923360|NCT05343390|141338050|SUPERIORITY||Rate Ratio|1.45||||0.01|TWO_SIDED|95.0|1.1|1.92|||Mixed Models Analysis|Negative binomial mixed-effect model||||1.92|1.10|0.01
70923361|NCT05343390|141338051|SUPERIORITY||Rate Ratio|1.28||||0.12|TWO_SIDED|95.0|0.94|1.76|||Mixed Models Analysis|Negative binomial mixed-effect model||||1.76|0.94|0.12
70923362|NCT05141903|141338104|SUPERIORITY||||||<|0.0001||||||(Dose group \* Time)|Mixed Models Analysis|Dfn, Dfd = 11, 369 F Value = 24.31||Dose Group 2 B. infantis levels compared to control group (antibiotic only) with changes over time||||<0.0001
70923363|NCT05141903|141338104|SUPERIORITY||||||<|0.0001||||||Dose group \* Time|Mixed Models Analysis|Dfn, Dfd = 11, 370 F value = 14.87||Dose Group 3 B. infantis levels compared to control group (antibiotic only) with changes over time||||<0.0001
70923364|NCT05141903|141338104|SUPERIORITY||||||<|0.0001||||||Dose Group \* Time|Mixed Models Analysis|Dfn, Dfd = 11, 351 F value = 8.606||Dose Group 2 (with HMO) B. infantis levels compared to dose Group 3 (without HMO) with changes over time||||<0.0001
71099038|NCT05287685|141706840|OTHER|||||||0.87|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline(week 0) to follow-up (week 16) scores.||||.87
70923365|NCT04640961|141338166|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
70923366|NCT04640961|141338167|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
70923367|NCT04640961|141338168|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
70923368|NCT03052608|141338171|SUPERIORITY||Hazard Ratio (HR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.191|0.413||The study was to be considered positive if the 1-sided log-rank test for PFS, stratified for baseline stratification factors (ethnicity and brain metastases) was significant at the 0.0081 level at the cutoff date of this report.|one-sided stratified log-rank|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Based on Cox Proportional Hazards model stratified by the presence of brain metastases and ethnic origin at randomization. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Lorlatinib.|The study was designed to test the null hypothesis H0: λ ≥1 versus the alternative hypothesis HA: λ \<1, where λ is the hazard ratio (HR; Lorlatinib/Crizotinib). Evaluation of 177 PFS events was required to have at least 90% power to detect a HR of 0.611 using a one-sided stratified log-rank test at a significance level of 0.025 (one-sided), and a 2-look group-sequential design with a Lan-DeMets (O'Brien-Fleming) α-spending function to determine the efficacy boundaries.||0.413|0.191|<0.0001
70923369|NCT03052608|141338172|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.414|1.249|||||Based on Cox Proportional Hazards model stratified by the presence of brain metastases and ethnic origin at randomization. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Lorlatinib.|||1.249|0.414|
70923370|NCT03052608|141338173|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.144|0.307|||one-sided stratified log-rank|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Based on Cox Proportional Hazards model stratified by the presence of brain metastases and ethnic origin at randomization. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Lorlatinib.|||0.307|0.144|<0.0001
70923371|NCT03052608|141338174|SUPERIORITY||Odds Ratio (OR)|2.254||||0.0005|TWO_SIDED|95.0|1.353|3.891|||Cochran-Mantel-Haenszel|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Odds ratio was estimated using Mantel-Haenszel method. An odds ratio larger than 1 indicates better outcome for Lorlatinib relative to Crizotinib. Exact CI was calculated.|||3.891|1.353|0.0005
70923372|NCT03052608|141338175|SUPERIORITY||Odds Ratio (OR)|2.499||||0.0002|TWO_SIDED|95.0|1.484|4.594|||Cochran-Mantel-Haenszel|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Odds ratio was estimated using Mantel-Haenszel method. An odds ratio larger than 1 indicates better outcome for Lorlatinib relative to Crizotinib. Exact CI was calculated.|||4.594|1.484|0.0002
71039658|NCT00354159|141587334|SUPERIORITY_OR_OTHER|||||||0.154||95.0|||||Mixed Models Analysis|||"Null Hypothesis: The change from baseline to the 12-month follow-up visit in eGFR values is the same between the Treatment arm and Control arm.~Alternative Hypothesis: The change from baseline to the 12-month follow-up visit in eGFR values is different between the Treatment arm and Control arm."||||0.154
71099039|NCT05287685|141706840|SUPERIORITY|||||||0.1|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at posttest (Week 8) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.10
71099040|NCT05287685|141706840|SUPERIORITY|||||||0.9|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at follow-up (Week 16) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.90
70992823|NCT02491073|141493743|OTHER||Geometric Mean Ratio|1.15|||||TWO_SIDED|90.0|1.09|1.22|||Geometric Mean Ratio||parameter dispersion type: Geometric Coefficient of Variation Dispersion Value : FT3: 0.178|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator.|1.22|1.09|
71039659|NCT00354159|141587337|SUPERIORITY_OR_OTHER|||||||0.583||95.0|||||Mixed Models Analysis|Response was change in MNLWHF score from baseline. Model adjusted for baseline MNLWHF score. Negative changes mean an improvement in MNLWHF score.||"Null Hypothesis: There is no difference in the change in MNLWHF score from baseline to 12-months between the Treatment Arm and Control Arm.~Alternative Hypothesis: There is a difference in the change in MNLWHF score from baseline to 12-months between the Treatment Arm and Control Arm."||||0.583
71099041|NCT05287685|141706841|EQUIVALENCE|Analysis to test whether groups had equivalent levels of satisfaction with treatment (defined as the groups not being significantly different at the level of p\<.05).||||||0.8|||||||t-test, 2 sided|||T-test analysis for the pilot RCT, comparing the outcome variable at posttest (Week 8) between the two groups.||||.80
71099042|NCT05287685|141706842|OTHER|||||||0.35|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline (week 0) to posttest (week 8) scores.||||.35
70992824|NCT02491073|141493744|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|Geometric Mean Ratio|1.01|||||TWO_SIDED|90.0|1.01|1.03|||||Parameter dispersion type: geometric coefficient of variation dispersion value 0.024|FT4|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.03|1.01|
70992825|NCT02491073|141493744|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|1.03|1.04|||||parameter dispersion value - geometric coefficient of variation dispersion value - 0.020|FT4|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.04|1.03|
70992826|NCT02491073|141493744|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.05|||||TWO_SIDED|90.0|1.05|1.06|||||parameter dispersion type - geometric coefficient variation dispersion value - 0.021|FT4|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.06|1.05|
70992827|NCT02491073|141493744|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.99|1.02|||||parameter dispersion type -geometric coefficient of variation dispersion value - 0.040|FT3|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.02|0.99|
70992828|NCT02491073|141493744|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geotmetric mean ratio|1.02|||||TWO_SIDED|90.0|1.0|1.03|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.041|FT3|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.03|1.00|
70992829|NCT02491073|141493744|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.03|||||TWO_SIDED|90.0|1.02|1.04|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.041|FT3|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.04|1.02|
71039660|NCT00354159|141587338|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.48||||0.368|TWO_SIDED|95.0|0.63|3.5||The P-value is from the Andersen-Gill model which adjusts for multiple VT/VF episodes per subject.|Andersen-Gill Model|Andersen-Gill model included a term for Treatment Arm. This model adjusts for multiple events per subject.||"Null Hypothesis: Rate of VT/VF episodes during the 12-month randomized period is the same between the Treatment Arm and the Control Arm.~Alternative Hypothesis: Rate of VT/VF episodes during the 12-month randomized period is different between the Treatment Arm and the Control Arm."||3.5|0.63|0.368
70992830|NCT02491073|141493745|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value -0.018|TSH|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|1.00|
70992831|NCT02491073|141493745|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.018|TSH|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|1.00|
70992832|NCT02491073|141493745|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.018|TSH||1.01|1.00|
70992833|NCT02491073|141493745|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|Geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.99|1.02|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.041|TT4|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator.|1.02|0.99|
70992834|NCT02491073|141493745|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|Slope|1.01|||||TWO_SIDED|90.0|1.0|1.02|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.033|TT4|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.02|1.00|
70992835|NCT02491073|141493745|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.99|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.036|TT4|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|0.99|
70992836|NCT02491073|141493745|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.98|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.047|TT3|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|0.98|
71039661|NCT04610580|141587380|OTHER||Geometric Least Square Mean Ratio (%)|95.0|||||TWO_SIDED|90.0|82.1|110.0||||||The formulation impact (12 × 1.25 mg EC mini-tablet versus 1 × 15 mg EC tablet) on plasma total Mo PK parameters was assessed using analysis of variance (ANOVA) statistical model with dosing period, treatment, and treatment sequence as the fixed effects and the participant (sequence) as a random effect, using the natural logarithms of the data.||110.0|82.1|
71039662|NCT04610580|141587381|OTHER||Geometric Least Square Mean Ratio (%)|96.243|||||TWO_SIDED|90.0|86.384|107.227||||||The formulation impact (12 × 1.25 mg EC mini-tablet versus 1 × 15 mg EC tablet) on plasma total Mo PK parameters was assessed using ANOVA statistical model with dosing period, treatment, and treatment sequence as the fixed effects and the participant (sequence) as a random effect, using the natural logarithms of the data.||107.227|86.384|
71039663|NCT04610580|141587382|OTHER||Geometric Least Square Mean Ratio (%)|94.9|||||TWO_SIDED|90.0|81.6|110.5||||||The formulation impact (12 × 1.25 mg EC mini-tablet versus 1 × 15 mg EC tablet) on plasma total Mo PK parameters was assessed using ANOVA statistical model with dosing period, treatment, and treatment sequence as the fixed effects and the participant (sequence) as a random effect, using the natural logarithms of the data.||110.5|81.6|
70923373|NCT03052608|141338176|SUPERIORITY||Odds Ratio (OR)|8.407|||<|0.0001|TWO_SIDED|95.0|2.586|27.233|||Cochran-Mantel-Haenszel|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Odds ratio was estimated using Mantel-Haenszel method. An odds ratio larger than 1 indicates better outcome for Lorlatinib relative to Crizotinib. Exact CI was calculated.|||27.233|2.586|<0.0001
71039664|NCT04610580|141587383|OTHER||Geometric Least Square Mean Ratio (%)|101.2|||||TWO_SIDED|90.0|70.6|145.1||||||The formulation impact (12 × 1.25 mg EC mini-tablet versus 1 × 15 mg EC tablet) on plasma total Mo PK parameters was assessed using ANOVA statistical model with dosing period, treatment, and treatment sequence as the fixed effects and the participant (sequence) as a random effect, using the natural logarithms of the data.||145.1|70.6|
71099043|NCT05287685|141706842|OTHER|||||||0.049|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline(week 0) to follow-up (week 16) scores.||||.049
70992837|NCT02491073|141493745|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.98|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.043|TT3|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|0.98|
70992838|NCT02491073|141493745|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.97|1.0|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.048|TT3|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.00|0.97|
71039665|NCT04610580|141587384|OTHER||Geometric Least Square Mean Ratio (%)|99.1|||||TWO_SIDED|90.0|89.3|109.9||||||The formulation impact (12 × 1.25 mg EC mini-tablet versus 1 × 15 mg EC tablet) on plasma total Mo PK parameters was assessed using ANOVA statistical model with dosing period, treatment, and treatment sequence as the fixed effects and the participant (sequence) as a random effect, using the natural logarithms of the data.||109.9|89.3|
71039666|NCT01097694|141587390|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||"Our null hypothesis was that the mean of this ratio will be 0 after log2-transformed.~The target enrollment was 60 assuming 10% drop-out for 54 completions which gave us 80% power to detect a doubling-dose change in PC20."||||<0.05
71039667|NCT01097694|141587391|SUPERIORITY||||||<|0.05|||||||Regression, Linear|Adjusted for baseline.||||||<0.05
71039668|NCT01097694|141587392|SUPERIORITY|||||||0.12|||||||Regression, Linear|Adjusted for baseline.||||||0.12
71039669|NCT01097694|141587393|SUPERIORITY|||||||0.1|||||||Regression, Linear|Adjusted for baseline.||||||0.10
71039670|NCT01097694|141587394|SUPERIORITY|||||||0.36|||||||Poisson regression model|||||||0.36
71039671|NCT01097694|141587395|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|adjusted for baseline values||For FEV1 we used a linear mixed-effects model to assess the between-group difference in the change from baseline over weeks 8-24.||||<0.05
71039672|NCT01097694|141587396|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|Adjusted for baseline.||For FEV1% we used a linear mixed-effects model to assess the between-group difference in the change from baseline over weeks 8-24.||||0.06
71039673|NCT01097694|141587397|SUPERIORITY|||||||0.38|||||||Mixed Models Analysis|Adjusted for baseline||||||0.38
71039674|NCT01097694|141587398|SUPERIORITY|||||||0.31|||||||Mixed Models Analysis|Adjusted for baseline.||||||0.31
71099044|NCT05287685|141706842|SUPERIORITY|||||||0.45|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at posttest (Week 8) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.45
71099045|NCT05287685|141706842|SUPERIORITY|||||||0.2|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at follow-up (Week 16) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.20
71099046|NCT05287685|141706843|OTHER|||||||0.006|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline (week 0) to posttest (week 8) scores.||||.006
71039675|NCT01097694|141587399|SUPERIORITY|||||||0.11|||||||Regression, Linear|Adjusted for baseline||||||0.11
71099047|NCT05287685|141706843|OTHER|||||||0.011|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline(week 0) to follow-up (week 16) scores.||||.011
71039676|NCT01097694|141587400|SUPERIORITY|||||||0.31|||||||Regression, Linear|Adjusted for baseline.||||||0.31
71039677|NCT01097694|141587401|SUPERIORITY|||||||0.11|||||||Regression, Linear|Adjusted for baseline||||||0.11
71039678|NCT01097694|141587402|SUPERIORITY|||||||0.62|||||||Regression, Linear|Adjusted for baseline.||||||0.62
71039679|NCT01097694|141587403|SUPERIORITY|||||||0.57|||||||Regression, Linear|Adjusted for baseline.||||||0.57
71039680|NCT01097694|141587404|SUPERIORITY|||||||0.15|||||||Regression, Linear|Adjusted for baseline||||||0.15
71039681|NCT01097694|141587405|SUPERIORITY|||||||0.33|||||||Regression, Linear|Adjusted for baseline.||||||0.33
71039682|NCT01097694|141587406|SUPERIORITY|||||||0.11|||||||Regression, Linear|Adjusted for baseline.||||||0.11
71039683|NCT01097694|141587407|SUPERIORITY|||||||0.07|||||||Regression, Linear|Adjusted for baseline.||||||0.07
71039684|NCT01097694|141587408|SUPERIORITY|||||||0.94|||||||Regression, Linear|Adjusted for baseline.||||||0.94
71039685|NCT01097694|141587409|SUPERIORITY|||||||0.13|||||||Regression, Linear|Adjusted for baseline||||||0.13
71039686|NCT01097694|141587410|SUPERIORITY|||||||0.25|||||||Regression, Linear|Adjusted for baseline||||||0.25
71039687|NCT01097694|141587411|SUPERIORITY|||||||0.54|||||||Regression, Linear|Adjusted for baseline.||||||0.54
71039688|NCT01097694|141587412|SUPERIORITY|||||||0.18|||||||Regression, Linear|Adjusted for baseline.||||||0.18
71039689|NCT01097694|141587413|SUPERIORITY|||||||0.56|||||||Regression, Linear|Adjusted for baseline.||||||0.56
71039690|NCT01097694|141587414|SUPERIORITY|||||||0.47|||||||Regression, Linear|Adjusted for baseline.||||||0.47
71039691|NCT02004691|141587424|SUPERIORITY||Least Squares Mean Difference|19.008|STANDARD_ERROR_OF_MEAN|4.7576|=|0.0004|TWO_SIDED|95.0|9.319|28.696||Threshold for significance was 0.05.|Mixed model for repeated measures||The 95% Confidence Interval (CI) and p-values were based on mixed model for repeated measures approach with Baseline Derived % Predicted DLco adjusted for Hb and pressure, age, treatment group, visit, and study visit by treatment group as covariates.|||28.696|9.319|=0.0004
71039692|NCT02004691|141587426|SUPERIORITY||Least Squares Mean Difference|-39.927|STANDARD_ERROR_OF_MEAN|3.4957|<|0.0001|TWO_SIDED|95.0|-47.051|-32.803||Threshold for significance was 0.05.|Mixed model for repeated measures||The 95% CI and p-values were based on a mixed model for repeated measures approach with Baseline Spleen Volume (MN), Baseline age, treatment group, study visit, and study visit by treatment group interaction as covariates.|||-32.803|-47.051|<.0001
71099048|NCT05287685|141706843|SUPERIORITY|||||||0.22|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at posttest (Week 8) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.22
71099049|NCT05287685|141706843|SUPERIORITY|||||||0.25|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at follow-up (Week 16) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.25
71099050|NCT02777190|141706849|NON_INFERIORITY|Margin of 4 hours|Mean Difference (Final Values)|-1.7||||0.09|ONE_SIDED|97.5||6.7|||t-test, 1 sided|one-sided two-sample t-test with alpha=0.025|Difference calculated as oral minus vaginal|||6.7||0.09
71099051|NCT02777190|141706850|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||||||0.54
71099052|NCT02777190|141706851|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||||||0.64
71099053|NCT02777190|141706852|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
71099054|NCT02777190|141706853|SUPERIORITY|||||||0.34|||||||Fisher Exact|||||||0.34
71099055|NCT02777190|141706854|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71099056|NCT02777190|141706855|SUPERIORITY|||||||0.6|||||||Fisher Exact|||||||0.60
71099057|NCT02777190|141706857|SUPERIORITY|||||||0.4|||||||Fisher Exact|||||||0.40
71099058|NCT02777190|141706858|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71099059|NCT02777190|141706859|SUPERIORITY|||||||0.04|||||||Fisher Exact|||||||0.04
71099060|NCT02777190|141706860|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71099061|NCT02777190|141706861|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
71099062|NCT03733483|141706877|EQUIVALENCE|Maximum likelihood estimates in a repeated measures model were used to assess the effect of insufficient sleep on P1NP levels. Change in P1NP in response to insufficient sleep was assessed using values measured every two hours on two, 24-h profiles obtained at baseline and on night 6 of sleep restriction. Circadian rhythmicity was included in the repeated-measures model as diurnal variation has been documented in prior studies. Data are presented as estimate ± standard error of the estimate.||||||0.53|||||||Mixed Models Analysis|||||||0.53
71099063|NCT03733483|141706878|EQUIVALENCE|Maximum likelihood estimates in a repeated measures model were used to assess the effect of insufficient sleep on CTX levels. Change in CTX in response to insufficient sleep was assessed using values measured every two hours on two, 24-h profiles obtained at baseline and on night 6 of sleep restriction. Circadian rhythmicity was included in the repeated-measures model as diurnal variation has been documented in prior studies. Data are presented as estimate ± standard error of the estimate.||||||0.1|||||||Mixed Models Analysis|||||||0.10
70992839|NCT02491073|141493746|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.11|||||TWO_SIDED|90.0|1.06|1.16|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.148|FT4|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator|1.16|1.06|
70992840|NCT02491073|141493746|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.13|||||TWO_SIDED|90.0|1.07|1.2|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.202|FT4|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator|1.20|1.07|
70992841|NCT02491073|141493746|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.11|||||TWO_SIDED|90.0|1.04|1.18|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.203|FT4|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator.|1.18|1.04|
70992842|NCT02491073|141493746|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.04|||||TWO_SIDED|90.0|0.99|1.1|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.179|FT4|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator.|1.10|0.99|
71099064|NCT00472641|141706879|SUPERIORITY_OR_OTHER||||||<|1e-05|||||||Random Regression Mixed Effects Modeling|||||||<0.00001
70923374|NCT03052608|141338177|SUPERIORITY||Hazard Ratio (HR)|0.07|||<|0.0001|TWO_SIDED|95.0|0.026|0.17|||one-sided stratified log-rank|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Based on Cox Proportional Hazards model stratified by the presence of brain metastases and ethnic origin at randomization. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Lorlatinib.|||0.170|0.026|<0.0001
70992843|NCT02491073|141493746|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.21|||||TWO_SIDED|90.0|1.15|1.52|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.178|FT3|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator|1.52|1.15|
70992844|NCT02491073|141493746|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.42|||||TWO_SIDED|90.0|1.33|1.52|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.224|FT3|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator|1.52|1.33|
70992845|NCT02491073|141493746|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.19|||||TWO_SIDED|90.0|1.12|1.27|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.203|FT3|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator|1.27|1.12|
71039693|NCT02004691|141587428|SUPERIORITY||Least Squares Mean Difference|1.618|STANDARD_ERROR_OF_MEAN|3.3877|=|0.6364|TWO_SIDED|95.0|-5.302|8.538||Threshold for significance was 0.15.|Mixed model for repeated measures||The 95% CI and p-values are based on a mixed model for repeated measures approach with Baseline Splenomegaly Related Score, Baseline age, treatment group, study visit, and study visit by treatment group interaction as covariates.|||8.538|-5.302|=0.6364
71039694|NCT02004691|141587433|SUPERIORITY||Least Squares Mean Difference|-26.596|STANDARD_ERROR_OF_MEAN|3.5862|<|0.0001|TWO_SIDED|95.0|-33.911|-19.281||Threshold for significance was 0.05.|Mixed model for repeated measures||The 95% CI and p-values are based on a mixed model for repeated measures approach with Baseline Liver Volume (MN), Baseline age, treatment group, study visit, and study visit by treatment group interaction as covariates.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in an order the outcome measure were reported and continued when previous endpoint was statistically significant at two-sided 0.05.||-19.281|-33.911|<.0001
71039695|NCT02004691|141587434|SUPERIORITY||Least Squares Mean Difference|14.332|STANDARD_ERROR_OF_MEAN|5.7822|=|0.0185|TWO_SIDED|95.0|2.564|26.099||Threshold for significance was 0.05.|Mixed model for repeated measures||The 95% CI and p-values are based on a mixed model for repeated measures approach with Baseline Platelets, Baseline age, treatment group, study visit, and study visit by treatment group interaction as covariates.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in an order the outcome measure were reported and continued when previous endpoint was statistically significant at two-sided 0.05.||26.099|2.564|=0.0185
70992846|NCT02491073|141493746|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.19|||||TWO_SIDED|90.0|1.11|1.27|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.215|FT3|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator|1.27|1.11|
70992847|NCT02491073|141493747|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value -0.018|TSH|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|1.00|
70992848|NCT02491073|141493747|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.018|TSH|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|1.00|
70992849|NCT02491073|141493747|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.018|TSH||1.01|1.00|
70992850|NCT01419665|141493748|EQUIVALENCE|The equivalence margin of + or - 12% was determined considering the variability of the point estimate of the add-on effect by taking a value lower than the lower boundary of the 95% CI for Rituximab+chemotherapy versus chemotherapy obtained from historical data.|difference in overall response rate|-0.4|||||TWO_SIDED|95.0|-5.94|5.14|||Binomial approximation|||||5.14|-5.94|
70992851|NCT01419665|141493751|OTHER|descriptive purposes, not powered for hypothesis testing|Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.97|1.76|||Regression, Cox|||||1.76|0.97|
70992852|NCT01419665|141493752|OTHER|descriptive purposes, not powered for hypothesis testing|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.55|1.52|||Regression, Cox|||||1.52|0.55|
70992853|NCT00127062|141493799|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70992854|NCT00127062|141493799|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71099065|NCT00472641|141706880|SUPERIORITY_OR_OTHER||||||<|1e-05|||||||Random Regression Mixed Effects Modeling|||||||<0.00001
71099066|NCT03721107|141706881|SUPERIORITY||Difference in Percentage|7.9||||0.152|TWO_SIDED|95.0|-6.0|21.9||P-value is from a 1-sided Pearson chi-square test with Yates' correction with null hypothesis that the difference in proportions Blautix - placebo \<=0 versus the difference is \>0. The significance level for rejection of the null hypotheses is 0.10.|Chi-squared, Corrected|||||21.9|-6.0|0.152
70992855|NCT01536119|141493817|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.12||||0.27|TWO_SIDED|95.0|0.91|1.38|||Chi-squared|||"Power analysis was conducted to a 15 % increase in exclusive breastfeeding rates (from 52% to 67%) with 80% power and an alpha of 0.05. A 25% attrition rate waas added. 107 couples were needed per group. Intention to treat analysis conducted.~Exclusive breastfeeding at 12 weeks"||1.38|0.91|0.27
70992856|NCT01536119|141493818|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.19||||0.09||95.0|0.98|1.44|||Chi-squared|||||1.44|0.98|0.09
70992857|NCT01536119|141493819|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.06||||0.06||95.0|1.0|1.13|||Fisher Exact|||||1.13|1.00|0.06
70992858|NCT01536119|141493820|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.02||95.0|1.01|1.19|||Chi-squared|||||1.19|1.01|0.02
70992859|NCT01536119|141493821|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Wilcoxon (Mann-Whitney)|||Brief scale used||||0.25
70992860|NCT01536119|141493822|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.29
70992861|NCT01536119|141493823|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||t-test, 2 sided|||||||0.12
70992862|NCT01536119|141493824|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.21
70992863|NCT01536119|141493825|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||t-test, 2 sided|||||||0.06
70992864|NCT01536119|141493826|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||t-test, 2 sided|||||||0.43
70992865|NCT00839423|141493971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7|STANDARD_ERROR_OF_MEAN|1.42|<|0.0001|TWO_SIDED|95.0|-8.49|-2.91||"A hierarchical hypothesis testing procedure was used. The comparison of 10 mg to placebo was primary.~Since p-value was \<0.05, hierarchically testing continued."|ANCOVA|||"The statistical model was an analysis of covariance (ANCOVA) of the change from baseline in MADRS total score (FAS, LOCF) with treatment and centre as fixed factors and the baseline MADRS score as a covariate.~Null hypothesis: No difference between 10 mg Vortioxetine and placebo at Week 6.~With 96 patients in each treatment arm and a standard deviation of 9 points, the power to detect a true effect of 3.7 points on the MADRS total score at Week 6 will be 80%."||-2.91|-8.49|<0.0001
70992866|NCT00839423|141493971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|STANDARD_ERROR_OF_MEAN|1.39|<|0.0001|TWO_SIDED|95.0|-8.64|-3.17||"The hierarchical hypothesis testing meant that comparison of 5 mg to placebo was performed at a 5% significance level since significance was achieved for the primary comparison of 10 mg to placebo.~Since p-value \<0.05, hierarchically testing contd."|ANCOVA|||"The statistical model was ANCOVA of the change from baseline in MADRS total score (FAS, LOCF) with treatment and centre as fixed factors and the baseline MADRS score as a covariate.~Null hypothesis: No difference between 5 mg Vortioxetine and placebo at Week 6."||-3.17|-8.64|<0.0001
70992867|NCT00839423|141493971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.42|STANDARD_ERROR_OF_MEAN|1.38|<|0.0001|TWO_SIDED|95.0|-9.13|-3.72||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||-3.72|-9.13|<0.0001
70992868|NCT00839423|141493972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.69||0.2377|TWO_SIDED|95.0|-2.17|0.54||"The hierarchical procedure meant that the above hypothesis was tested at a 5% significance level since significance was achieved for both 10 and 5 mg at Week 6.~Since p-value was \>0.05, hierarchically testing stopped here."|ANCOVA|||"The statistical model was ANCOVA of the change from baseline in MADRS total score (FAS, LOCF) with treatment and centre as fixed factors and the baseline MADRS score as a covariate.~Null hypothesis: No difference between 10 mg Vortioxetine and placebo at Week 1."||0.54|-2.17|0.2377
71099067|NCT03721107|141706881|SUPERIORITY||Difference in Percentage|5.6||||0.216|TWO_SIDED|95.0|-6.8|18.0||P-value is from a 1-sided Pearson chi-square test with Yates' correction with null hypothesis that the difference in proportions Blautix - placebo \<=0 versus the difference is \>0. The significance level for rejection of the null hypotheses is 0.10.|Chi-squared, Corrected|||||18.0|-6.8|0.216
71099068|NCT01378273|141706903|SUPERIORITY|We assumed no effect of treatment on death, but that Epo will lead to a decrease in the rate of NDI. If we assume a multiplicative reduction in the NDI rate of 0.45 then we expect a treated NDI rate of 12 percent and an overall rate of death+NDI of 30.4% as compared to the control rate of 40.4% corresponding to an overall treatment rate ratio of 0.75. This leads to a sample size of 376 evaluated subjects per arm or a total evaluated sample size of 752 subjects.|Risk Ratio (RR)|1.03||||0.05|TWO_SIDED|0.05|0.81|1.32||A two-sided type I error of 0.05 with no formal adjustment for multiple comparisons unless otherwise specified (such as with safety outcomes).|GEE Wald test based on logistic regressi|adjustments were made for gestational age at birth and recruitment site as a fixed effect.|The numerator is the Epo group, denominator is the control group|We evaluated the primary outcome of death or neurodevelopmental impairment using generalized estimating equations to account for potential correlation within siblings from the same pregnancy, with adjustment for gestational age at birth and recruitment site as a fixed effect. The primary analysis included infants with complete data and excluded data from infants known to be alive but in whom neurodevelopmental outcomes were not assessed.||1.32|0.81|0.05
71039696|NCT02004691|141587435|SUPERIORITY||Least Squares Mean Difference|-0.056|STANDARD_ERROR_OF_MEAN|0.7384|=|0.94|TWO_SIDED|95.0|-1.566|1.454||Threshold for significance was 0.05.|Mixed model for repeated measures||The 95% CI and p-values are based on a mixed model for repeated measures approach with Baseline BFI item 3 (Worst Fatigue), Baseline age, treatment group, study visit, and study visit by treatment group interaction as covariates.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in an order the outcome measure were reported and continued when previous endpoint was statistically significant at two-sided 0.05.||1.454|-1.566|=0.9400
71039697|NCT01320722|141587438|SUPERIORITY|||||||0.72|||||||Repeated Measures Analysis|||Week 8||||0.72
71039698|NCT01320722|141587439|SUPERIORITY|||||||0.77||||||Statistical significance was set for P\>0.05.|t-test, 2 sided|||Week 8||||0.77
71039699|NCT01320722|141587440|SUPERIORITY|||||||0.57||||||Statistical significance was set for P\>0.05.|t-test, 2 sided|||Week 8||||0.57
71039700|NCT01320722|141587441|SUPERIORITY|||||||0.8|||||||Repeated Measures Analysis|||||||0.8
71039701|NCT01320722|141587441|SUPERIORITY|||||||0.6|||||||Repeated Measures Analysis|||||||0.6
71039702|NCT01320722|141587442|SUPERIORITY|||||||0.6|||||||Repeated Measures Analysis|||||||0.6
71039703|NCT01320722|141587442|SUPERIORITY|||||||0.7|||||||Repeated Measures Analysis|||||||0.7
71039704|NCT01320722|141587443|SUPERIORITY|||||||0.3|||||||Repeated Measures Analysis|||||||0.3
71039705|NCT01320722|141587443|SUPERIORITY|||||||0.1|||||||Repeated Measures Analysis|||||||0.1
71039706|NCT01320722|141587444|SUPERIORITY_OR_OTHER|||||||0.35|||||||t-test, 2 sided|Statistical significance was set for a 2-tailed P \<0.05.||Week 8||||0.35
71039707|NCT01320722|141587444|SUPERIORITY|||||||0.7||||||Statistical significance was set for a 2-tailed P \<0.05.|t-test, 2 sided|||Week 8||||0.7
71039708|NCT01320722|141587444|SUPERIORITY|||||||0.06||||||Statistical significance was set for a 2-tailed P \<0.05.|t-test, 2 sided|||Week 8||||0.06
71039709|NCT01320722|141587445|SUPERIORITY|||||||0.92||||||Statistical significance was set for P\>0.05.|Repeated Measures Analysis|||Overall SBP||||0.92
71039710|NCT01320722|141587445|SUPERIORITY|||||||0.64||||||Statistical significance was set for P\>0.05.|Repeated Measures Analysis|||Overall DBP||||0.64
71039711|NCT01320722|141587445|SUPERIORITY|||||||0.8||||||Statistical significance was set for P\>0.05.|Repeated Measures Analysis|||Awake SBP||||0.80
71039712|NCT01320722|141587445|SUPERIORITY|||||||0.97||||||Statistical significance was set for P\>0.05.|Repeated Measures Analysis|||Asleep SBP at Week 8||||0.97
71039713|NCT01320722|141587445|SUPERIORITY|||||||0.34|||||||Repeated Measures Analysis|||Overall SBP||||0.34
71039714|NCT01320722|141587445|SUPERIORITY|||||||0.59|||||||Repeated Measures Analysi|||Overall DBP||||0.59
71039715|NCT01320722|141587445|SUPERIORITY|||||||0.57|||||||Repeated Measures Analysis|||Awake SBF||||0.57
71039716|NCT01320722|141587445|SUPERIORITY|||||||0.08|||||||Repeated Measures Analysis|||Asleep SBP||||0.08
71039717|NCT01320722|141587445|SUPERIORITY|||||||0.59|||||||Repeated Measures Analysis|||Overall SBP||||0.59
71039718|NCT01320722|141587445|SUPERIORITY|||||||0.53|||||||Repeated Measures Analysis|||||||0.53
71039719|NCT01320722|141587445|SUPERIORITY|||||||0.55|||||||Repeated Measures Analysis|||Awake SBP||||0.55
71039720|NCT01320722|141587445|SUPERIORITY|||||||0.8|||||||Repeated Measures Analysis|||Asleep SBP||||0.80
71039721|NCT01320722|141587446|SUPERIORITY|||||||0.98|||||||Repeated Measures Analysis|||||||0.98
71039722|NCT01320722|141587446|SUPERIORITY|||||||0.07|||||||Repeated Measures Analysis|||||||0.07
71039723|NCT01320722|141587446|SUPERIORITY|||||||0.97|||||||Repeated Measures Analysis|||||||0.97
71039724|NCT00021541|141587449|SUPERIORITY|||||||0.012|||||||Repeated measures ANOVA|||||||0.012
71039725|NCT00021541|141587449|OTHER|||||||0.015|||||||Repeated measures ANOVA|||Post hoc test: tipifarnib group F=7.40||||0.015
70992869|NCT00839423|141493972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.67||0.7489|TWO_SIDED|95.0|-1.54|1.11||The hierarchical procedure meant that the above hypothesis was not tested since significance was not achieved for 10 mg at Week 1. A nominal p-value is provided.|ANCOVA|||"The statistical model was ANCOVA of the change from baseline in MADRS total score (FAS, LOCF) with treatment and centre as fixed factors and the baseline MADRS score as a covariate.~Null hypothesis: No difference between 5 mg Vortioxetine and placebo at Week 1."||1.11|-1.54|0.7489
70992870|NCT00839423|141493972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|0.67||0.4142|TWO_SIDED|95.0|-0.77|1.85||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||1.85|-0.77|0.4142
70992871|NCT00839423|141493973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.28|STANDARD_ERROR_OF_MEAN|1.22|<|0.0001|TWO_SIDED|95.0|-7.69|-2.88||A nominal p-value is provided.|ANCOVA|||||-2.88|-7.69|<0.0001
70992872|NCT00839423|141493973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.33|STANDARD_ERROR_OF_MEAN|1.25|<|0.0001|TWO_SIDED|95.0|-7.79|-2.88||A nominal p-value is provided.|ANCOVA|||||-2.88|-7.79|<0.0001
70992873|NCT00839423|141493974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|1.0||0.0011|TWO_SIDED|95.0|-5.27|-1.33||A nominal p-value is provided.|ANCOVA|||||-1.33|-5.27|0.0011
70992874|NCT00839423|141493974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|1.02||0.0034|TWO_SIDED|95.0|-5.01|-1.0||A nominal p-value is provided.|ANCOVA|||||-1.00|-5.01|0.0034
71039726|NCT00021541|141587449|OTHER|||||||0.66|||||||Repeated measures ANOVA|||Post hoc test: placebo group F=0.19||||0.66
70992875|NCT00839423|141493975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.28|-0.52||A nominal p-value is provided.|ANCOVA|||||-0.52|-1.28|<0.0001
70992876|NCT00839423|141493975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.34|-0.56||A nominal p-value is provided.|ANCOVA|||||-0.56|-1.34|<0.0001
70992877|NCT00839423|141493976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.16||0.0003|TWO_SIDED|95.0|-0.9|-0.27||A nominal p-value is provided.|ANCOVA|||||-0.27|-0.90|0.0003
70992878|NCT00839423|141493976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.16||0.0003|TWO_SIDED|95.0|-0.92|-0.27||A nominal p-value is provided.|ANCOVA|||||-0.27|-0.92|0.0003
70992879|NCT00839423|141493977|SUPERIORITY_OR_OTHER||Difference %|21.9||||0.002|TWO_SIDED|95.0|8.89|34.92||A nominal p-value is provided.|Fisher Exact|||||34.92|8.89|0.002
70992880|NCT00839423|141493977|SUPERIORITY_OR_OTHER||Difference %|23.34||||0.001|TWO_SIDED|95.0|10.05|36.43||A nominal p-value is provided.|Fisher Exact|||||36.43|10.05|0.001
70992881|NCT00839423|141493978|SUPERIORITY_OR_OTHER||Difference %|22.41||||0.001|TWO_SIDED|95.0|9.74|35.07||A nominal p-value is provided.|Fisher Exact|||||35.07|9.74|0.001
70992882|NCT00839423|141493978|SUPERIORITY_OR_OTHER||Difference %|22.33||||0.001|TWO_SIDED|95.0|9.39|35.28||A nominal p-value is provided.|Fisher Exact|||||35.28|9.39|0.001
71039727|NCT03407729|141587453|OTHER|Using seed-based analysis with a 1) Left Thalamus seed and 2) Left Middle Temporal Gyrus seed, cluster size was set at 50 voxels and p-value was thresholded at p\<0.05. This was used to compare the differences between the two study groups in terms of number of activated voxels during during cognitive testing using the N-back.|||||<|0.05||||||The a priori threshold for statistical significance was p\<0.05 and statistical power was set at a minimum of 0.80.|t-test, 2 sided|||||||<0.05
71039728|NCT02413008|141587462|OTHER|The primary endpoint, the variation of FSH between week 12 and baseline and also comparing by arm will be analyzed using a non-parametric test (Mann-Whitney-Wilcoxon test).||||||0.1|||||||Wilcoxon (Mann-Whitney)|||"The variations of the levels of FSH after treatment was studied in each women at baseline, week 3 and week12 weeks, the variation of levels between two arms were analysed using a non-parametric test Mann-Whitney-Wilcoxon.~The intra individual variation (differences between the pre study determinations screening and baseline) was compared to the variation between baseline and the values obtained at every study visit."||||0.10
71039729|NCT02413008|141587462|OTHER|The primary endpoint, the variation of FSH between week 12 and baseline and also comparing by arm will be analyzed using a non-parametric test (Mann-Whitney-Wilcoxon test).||||||0.413|||||||Wilcoxon (Mann-Whitney)|||The variations in the intensities for each one of the symptoms and signs of the vaginal atrophy, after 3 and 12 weeks, in each treatment arm, will be compared using the non-parametric test Mann-Whitney-Wilcoxon.||||0.413
71039730|NCT02413008|141587462|OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
71039731|NCT02413008|141587463|OTHER||||||<|0.05|||||||Dunn Test|||Variation in serum levels of FSH at week 1||||<0.05
71039732|NCT02413008|141587463|OTHER||||||<|0.05|||||||Dunn Test|||Variation in serum levels of FSH at week 3||||<0.05
71039733|NCT02413008|141587463|OTHER||||||>|0.05|||||||Dunn Test|||Variation in serum levels of FSH at week 8||||>0.05
71039734|NCT02413008|141587464|OTHER||||||>|0.05|||||||Dunn Test|||Change in serum levels of Luteinizing hormone (LH) from baseline to week 1||||>0.05
71039735|NCT02413008|141587464|OTHER||||||>|0.05|||||||Dunn Test|||Change in serum levels of Luteinizing hormone (LH) from baseline to week 3||||>0.05
71039736|NCT02413008|141587464|OTHER||||||>|0.05|||||||Dunn Test|||Change in serum levels of Luteinizing hormone (LH) from baseline to week 8||||>0.05
71039737|NCT02413008|141587464|OTHER|||||||0.135|||||||Wilcoxon (Mann-Whitney)|||Change in serum levels of Luteinizing hormone (LH) from baseline to week 12||||0.135
71039738|NCT02413008|141587465|OTHER|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 1 in plasma levels of estriol||||0.043
71039739|NCT02413008|141587465|OTHER|||||||0.649|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 3 in plasma levels of estriol||||0.649
71039740|NCT02413008|141587465|OTHER|||||||0.588|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 8 in plasma levels of estriol||||0.588
71039741|NCT02413008|141587465|OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 12 in plasma levels of estriol||||0.67
71039742|NCT02413008|141587466|OTHER|||||||0.342|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 1 in plasma levels of estradiol.||||0.342
71039743|NCT02413008|141587466|OTHER|||||||0.523|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 3 in plasma levels of estradiol.||||0.523
71039744|NCT02413008|141587466|OTHER|||||||0.523|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estradiol from baseline to week 8||||0.523
70992883|NCT03377244|141493984|SUPERIORITY|||||||0.1013||||||The p-value above reflects results of between-arms analysis of percent change in weight from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.1013
70992884|NCT03377244|141493985|SUPERIORITY|||||||0.495||||||The p-value above reflects results of between-arms analysis of change in mean HbA1c from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment.||||||0.4950
70992885|NCT03377244|141493986|SUPERIORITY|||||||0.7416||||||The p-value above reflects results of between-arms analysis of change in systolic blood pressure from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.7416
70992886|NCT03377244|141493987|SUPERIORITY|||||||0.0702||||||The p-value above reflects results of between-arms analysis of change in diastolic blood pressure from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.0702
70992887|NCT03377244|141493988|SUPERIORITY|||||||0.007||||||The p-value above reflects results of between-arms analysis of change in eating habits self-efficacy scores from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.0070
70992888|NCT03377244|141493989|SUPERIORITY|||||||0.0009||||||The p-value above reflects results of between-arms analysis of change in physical activity self-efficacy scale scores from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.0009
70992889|NCT03377244|141493990|SUPERIORITY|||||||0.374||||||The p-value above reflects results of between-arms analysis for the probability of participants to engage in sufficient physical activity at 6 months post-intervention.|Regression, Logistic|Model adjusted for age, sex, education, marital status, employment status, and baseline physical activity.||||||0.3740
71039745|NCT02413008|141587466|OTHER|||||||0.163|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estradiol from baseline to week 12||||0.163
71039746|NCT02413008|141587467|OTHER|||||||0.418|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estrona from baseline to week 1||||0.418
71039747|NCT02413008|141587467|OTHER|||||||0.642|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estrona from baseline to week 3||||0.642
71039748|NCT02413008|141587467|OTHER|||||||0.175|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estrona from baseline to week 8||||0.175
71102639|NCT01979185|141713916|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% CI of the geometric mean ratios fell within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|0.63|||||TWO_SIDED|90.0|0.543|0.73|||Mixed-effects Model|||The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects, and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in pharmacokinetic parameters, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.||0.730|0.543|
70992890|NCT03377244|141493991|SUPERIORITY|||||||0.9556||||||The p-value above reflects results of between-arms analysis of change in participants' sugar-sweetened beverage consumption per day from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.9556
70992891|NCT03377244|141493992|SUPERIORITY|||||||0.1726||||||The p-value above reflects results of between-arms analysis of change in participants' fruit and vegetable consumption scale scores from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.1726
70992892|NCT03377244|141493993|SUPERIORITY|||||||0.0478||||||The p-value above reflects results of between-arms analysis of change in participants' family support scale scores from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.0478
70992893|NCT01774344|141494012|SUPERIORITY||Hazard Ratio (HR)|0.624|||=|1.7e-05|TWO_SIDED|95.0|0.498|0.782|||Log Rank|||Hazard ratio for OS and 95% confidence interval was calculated for stratified IVRS by using Cox model, stratified by the geographic region: Asia or Rest of the World (ROW), ECOG-PS: 0 versus 1, AFP level, presence versus absence of extrahepatic disease and presence versus absence of macrovascular invasion. Kaplan-Meier (KM) estimated for OS and KM survival curves were presented for each treatment arm.||0.782|0.498|= 0.000017
71039749|NCT02413008|141587467|OTHER|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estrona from baseline to week 12||||0.084
71039750|NCT02413008|141587468|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Change in pH between baseline and week 3||||<0.01
71039751|NCT02413008|141587468|OTHER|||||||0.057|||||||Wilcoxon (Mann-Whitney)|||Change in pH between baseline and week 12||||0.057
71039752|NCT02413008|141587469|OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Changes in dyspareunia from baseline to week 3||||0.14
71039753|NCT02413008|141587469|OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Changes in dyspareunia from baseline to week 12||||0.25
71039754|NCT02413008|141587470|OTHER|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 3||||0.28
71039755|NCT02413008|141587470|OTHER|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 12||||0.34
71039756|NCT02413008|141587471|OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Changes in vaginal dryness from baseline to week 3||||0.14
71039757|NCT02413008|141587471|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Changes in vaginal dryness from baseline to week 12||||<0.01
71039758|NCT02413008|141587472|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Changes in total score of symptoms of vaginal atrophy from baseline to week 3||||0.03
71039759|NCT02413008|141587472|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Changes in total score of symptoms of vaginal atrophy from baseline to week 12||||0.04
71039760|NCT02413008|141587473|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Changes in dryness of the mucosa between baseline and week 3||||<0.001
71039761|NCT02413008|141587473|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Changes in dryness of the mucosa betweeen baseline and week 12||||<0.01
71039762|NCT02413008|141587474|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Changes in dryness of the mucosa between baseline and week 3||||0.13
70992894|NCT01774344|141494012|SUPERIORITY||Hazard Ratio (HR)|0.66|||=|0.000149|TWO_SIDED|95.0|0.527|0.828|||Log Rank|||Hazard ratio for OS and 95% confidence interval was calculated for stratified RAVE (Sensitivity) by using Cox model, stratified by the geographic region: Asia or Rest of the World (ROW), ECOG-PS: 0 versus 1, AFP level, presence versus absence of extrahepatic disease and presence versus absence of macrovascular invasion. Kaplan-Meier (KM) estimated for OS and KM survival curves were presented for each treatment arm.||0.828|0.527|= 0.000149
70992895|NCT01774344|141494012|SUPERIORITY||Hazard Ratio (HR)|0.674|||=|0.000107|TWO_SIDED|95.0|0.546|0.831|||Log Rank|||Hazard ratio for OS and 95% confidence interval was calculated for unstratified (sensitivity) by using Cox model, stratified by the geographic region: Asia or Rest of the World (ROW), ECOG-PS: 0 versus 1, AFP level, presence versus absence of extrahepatic disease and presence versus absence of macrovascular invasion. Kaplan-Meier (KM) estimated for OS and KM survival curves were presented for each treatment arm.||0.831|0.546|= 0.000107
71039763|NCT02413008|141587474|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Changes in dryness of the mucosa between baseline and week 12||||<0.01
70992896|NCT01774344|141494013|SUPERIORITY||Hazard Ratio (HR)|0.439|||<|1e-06|TWO_SIDED|95.0|0.355|0.542|||Log Rank|||Hazard ratio and its 95% CI was based on stratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Kaplan-Meier estimates.||0.542|0.355|< 0.000001
70992897|NCT01774344|141494013|SUPERIORITY||Hazard Ratio (HR)|0.471|||<|1e-06|TWO_SIDED|95.0|0.388|0.572|||Log Rank|||Hazard ratio and its 95% CI was based on unstratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Kaplan-Meier estimates.||0.572|0.388|< 0.000001
70992898|NCT01774344|141494013|SUPERIORITY||Hazard Ratio (HR)|0.412|||<|1e-06|TWO_SIDED|95.0|0.334|0.509|||Log Rank|||Hazard ratio and its 95% CI was based on stratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Kaplan-Meier estimates.||0.509|0.334|< 0.000001
71039764|NCT02413008|141587475|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 3||||<0.001
71039765|NCT02413008|141587475|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 12||||<0.001
71039766|NCT02413008|141587476|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change in total score of signs between week 3 and baseline||||<0.001
71039767|NCT02413008|141587476|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change in total score of signs between week 12 and baseline||||<0.001
71099069|NCT01378273|141706904|OTHER|SAEs were defined prospectively. The rate of total SAEs observed through hospital discharge were compared after accounting for potential within-sibship correlation (with multiple gestations) using Generalized Estimating Equations (GEE) with robust standard errors. We used a GEE Wald test based on Poisson or logistic regression for total SAE count and individual events respectively. All other non-categorical data were assessed with GEE regression models appropriate for continuous outcomes.|Risk Ratio (RR)|1.01||||0.05|TWO_SIDED|95.0|0.83|1.22||Statistical significance was set at 0.05 for the efficacy analysis and for the final safety analysis comparing the rate of total SAEs between treatment groups, and 0.031 for death and 0.004 for the ten individual SAEs due to sequential monitoring.|Poisson regression|Adjusted for multiple gestation and gestational age|Epo is numerator and Control is denominator|We hypothesized that Epo would be safe, with no excess of SAEs compared to control infants. Sample size was based on the primary outcome, severe neurodevelopmental impairment or death.||1.22|0.83|0.05
70992899|NCT01774344|141494013|SUPERIORITY||Hazard Ratio (HR)|0.444|||<|1e-06|TWO_SIDED|95.0|0.365|0.539|||Log Rank|||Hazard ratio and its 95% CI was based on unstratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Kaplan-Meier estimates.||0.539|0.365|< 0.000001
71039768|NCT02413008|141587477|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Change in maturation value from baseline to week 3||||<0.0001
71039769|NCT02413008|141587477|OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||Change in maturation value from baseline to week 12||||0.006
71039770|NCT04387617|141587478|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_DEVIATION|2.6||0.5|TWO_SIDED|95.0|-0.8|1.6|||t-test, 2 sided|||||1.6|-0.8|0.5
71039771|NCT01139762|141587522|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.41||||0.001|TWO_SIDED|95.0|-2.27|-0.55|||Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.55|-2.27|0.001
71039772|NCT01139762|141587524|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.51||||0.007|TWO_SIDED|95.0|-0.87|-0.14||P-value is for IPSS storage (irritative) subscore - 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.14|-0.87|0.007
71039773|NCT01139762|141587524|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.41||||0.04|TWO_SIDED|95.0|-0.8|-0.02||P-value is for IPSS storage (irritative) subscore - 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.02|-0.80|0.040
70992900|NCT01774344|141494014|SUPERIORITY||Hazard Ratio (HR)|0.453|||<|1e-06|TWO_SIDED|95.0|0.369|0.555|||Log Rank|||Hazard ratio and its 95% CI was based on stratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.||0.555|0.369|< 0.000001
70992901|NCT01774344|141494014|SUPERIORITY||Hazard Ratio (HR)|0.48|||<|1e-06|TWO_SIDED|95.0|0.397|0.58|||Log Rank|||Hazard ratio and its 95% CI was based on unstratified Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.||0.580|0.397|< 0.000001
70992902|NCT01774344|141494014|SUPERIORITY||Hazard Ratio (HR)|0.425|||<|1e-06|TWO_SIDED|95.0|0.347|0.522|||Log Rank|||Hazard ratio and its 95% CI was based on stratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.||0.522|0.347|< 0.000001
70992903|NCT01774344|141494014|SUPERIORITY||Hazard Ratio (HR)|0.454|||<|1e-06|TWO_SIDED|95.0|0.376|0.548|||Log Rank|||Hazard ratio and its 95% CI was based on unstratified Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.||0.548|0.376|< 0.000001
70992904|NCT01774344|141494015|SUPERIORITY||Difference|-6.88|||=|0.00365|TWO_SIDED|95.0|-11.13|-2.63|||Cochran-Mantel-Haenszel|||Comparison of treatments were calculated.||-2.63|-11.13|= 0.003650
70992905|NCT01774344|141494015|SUPERIORITY||Difference|-4.15|||=|0.019991|TWO_SIDED|95.0|-7.55|-0.75|||Cochran-Mantel-Haenszel|||Comparison of treatments were calculated.||-0.75|-7.55|= 0.019991
71099070|NCT01378273|141706905|SUPERIORITY|||||||0.36||||||Statistical significance was evaluated using a Wald's test and declared significant if p \< 0.05.|Generalized estimating equation|Adjusted for gestational age at birth and treatment assignment.||For all statistical comparisons between groups, Generalized Estimating Equations (GEE) with robust standard errors and a working independence correlation structure for infants included from a multiple gestation were used. A GEE-based Wald test was used to examine differences in the global brain injury severity score between treatment groups, with adjustment for gestational age (GA) at birth used to stratify treatment randomization (24+0 to 25+6 vs. 26+0 to 27+6 in weeks+days of GA).||||0.36
71099071|NCT01378273|141706906|SUPERIORITY||||||<|0.001||||||Statistical significance was evaluated using a Wald's test and declared significant if p \< 0.007.|Generalized estimating equation|Adjusted for gestational age at birth and treatment assignment.||For statistical inference, we utilized generalized estimating equations (GEE) with robust standard errors to appropriately account for potential correlation of biomarkers for same-birth siblings. Each respective GEE model adjusted for gestational age at birth and treatment assignment as fixed factors associated with the original study design. Biomarker levels at each follow-up time point were analysed using separate GEE models. Epo levels were log-transformed in all statistical analyses.||||<0.001
71099072|NCT05259722|141706934|SUPERIORITY||Mean Difference (Net)|-16.1|||<|0.001|TWO_SIDED|95.0|-23.28|-8.86|||ANCOVA|||The change from baseline was analysed using an ANCOVA model with effects of treatment group, hyperkeratotic/non-hyperkeratotic subtype and baseline value of the score. Missing data was imputed with WOCF. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||-8.86|-23.28|<0.001
71099073|NCT05259722|141706935|SUPERIORITY||Risk Difference (RD)|12.6|||=|0.003|TWO_SIDED|95.0|4.34|20.78|||Cochran-Mantel-Haenszel|||The difference in response rates was analysed using the Cochran-Mantel-Haenszel test stratified by hyperkeratotic/non-hyperkeratotic subtype. Missing data was imputed as non-response. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||20.78|4.34|=0.003
71099074|NCT05259722|141706936|SUPERIORITY||Risk Difference (RD)|10.6|||=|0.004|TWO_SIDED|95.0|3.31|17.87|||Cochran-Mantel-Haenszel|||The difference in response rates was analysed using the Cochran-Mantel-Haenszel test stratified by hyperkeratotic/non-hyperkeratotic subtype. Missing data was imputed as non-response. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||17.87|3.31|=0.004
71099075|NCT05259722|141706937|SUPERIORITY||Mean Difference (Net)|-0.7|||=|0.005|TWO_SIDED|95.0|-1.12|-0.2|||ANCOVA|||The change from baseline was analysed using an ANCOVA model with effects of treatment group, hyperkeratotic/non-hyperkeratotic subtype and baseline value of the score. Missing data was imputed with WOCF. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||-0.20|-1.12|=0.005
70992906|NCT01774344|141494016|SUPERIORITY||Difference|-29.31|||<|1e-06|TWO_SIDED|95.0|-37.52|-21.11|||Cochran-Mantel-Haenszel|||Comparison of treatments were calculated.||-21.11|-37.52|< 0.000001
70992907|NCT01774344|141494016|SUPERIORITY||Difference|-31.39|||<|1e-06|TWO_SIDED|95.0|-39.57|-23.22|||Cochran-Mantel-Haenszel|||Comparison of treatments were calculated.||-23.22|-39.57|< 0.000001
70992908|NCT01735617|141494023|SUPERIORITY_OR_OTHER||Geometric means|563.38|STANDARD_DEVIATION|162.51|||TWO_SIDED|||||||||The pharmacokinetic profile was characterised by an overnight rise in cortisol levels reaching a maximal concentration approximately 8 hours post dosing.||||
70992909|NCT02344407|141494033|SUPERIORITY|||||||0.68|||||||Chi-squared|Bernards Exact Test Chi-square||Each active vaccine is compared to the placebo group||||0.68
70992910|NCT02344407|141494033|SUPERIORITY|||||||0.68|||||||Chi-squared|Barnard Exact Test Chi-square||||||0.68
70992911|NCT02344407|141494034|SUPERIORITY||||||<|0.001|||||||ANCOVA|Linear regression (analysis of covariance) adjusted for baseline antibody level||||||<0.001
70992912|NCT02344407|141494034|SUPERIORITY||||||<|0.001|||||||ANCOVA|Analysis of covariance adjusting for baseline antibody level||||||<0.001
70992913|NCT01658579|141494059|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.75|STANDARD_ERROR_OF_MEAN|2.179||0.7304|TWO_SIDED|95.0|-3.614|5.124|||Linear Mixed Model|||Analysis was performed using a linear mixed model with treatment and period as fixed effects, and participant as random effect.||5.124|-3.614|0.7304
70992914|NCT00608530|141494070|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||Repeated measures analysis of variance compared differences between and within groups (CBT and Supportive Care) from baseline to end of treatment. Statistical testing was performed using 2-tailed tests and alpha level of .05 for declaring statistical significance. The trial was powered at the \>.80 level to detect differences between condition based on projected sample N = 130; given the N = 66 actually achieved our a priori power for detecting differences between groups was .63.||||.05
70992915|NCT00608530|141494071|SUPERIORITY|||||||0.05|||||||ANOVA|||Primary analyses consisted of modified intent-to-treat analysis of all randomized participants who attended at least 1 treatment session, with multiple imputation to address missing data. The study was powered at 80% to detect large effect sizes (\>.50SD) and alpha of .05 with a recruitment goal N = 140; with the N = 61 actually obtained, our a priori power was .55 to detect between group differences.||||.05
70992916|NCT00608530|141494072|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||Repeated measures analysis of variance comparing groups at baseline and end of treatment.||||>0.05
70992917|NCT00608530|141494074|SUPERIORITY_OR_OTHER|||||||0.05|||||||Fisher Exact|||||||.05
70992918|NCT01019486|141494081|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Independent Student t test between arms with two tailed analysis||||<0.05
70992919|NCT01019486|141494081|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Independent Student t test between arms with two tailed analysis.||||<0.05
70992920|NCT01019486|141494081|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Independent Student t test between groups with two-tailed analysis||||<0.05
70992921|NCT01019486|141494082|NON_INFERIORITY_OR_EQUIVALENCE|If sufficient subjects were enrolled then it would be expected that the MRI measurement of myocardial blood flow MBF would similar or equivalent to the invasively measured CFR in response to intravenous regadenoson administration.|None insufficient data|2.0||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||No analysis was performed due to limited data.||||0.05
70992922|NCT01019486|141494083|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Comparison between groups using a two-tailed Student t test||||<.05
71099076|NCT05259722|141706938|SUPERIORITY||Mean Difference (Net)|-0.6|||=|0.018|TWO_SIDED|95.0|-1.08|-0.1|||ANCOVA|||The change from baseline was analysed using an ANCOVA model with effects of treatment group, hyperkeratotic/non-hyperkeratotic subtype and baseline value of the score. Missing data was imputed with WOCF. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||-0.10|-1.08|=0.018
70992923|NCT05373706|141494089|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|0.95||||0.68|TWO_SIDED|95.0|0.76|1.2|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.20|0.76|0.68
70992924|NCT05373706|141494089|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.1||||0.56|TWO_SIDED|95.0|0.81|1.49|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.49|0.81|0.56
70992925|NCT05373706|141494090|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|0.93||||0.68|TWO_SIDED|95.0|0.64|1.33|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.33|0.64|0.68
70992926|NCT05373706|141494090|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.24||||0.3|TWO_SIDED|95.0|0.82|1.88|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.88|0.82|0.30
70992927|NCT05373706|141494091|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|0.89||||0.36|TWO_SIDED|95.0|0.69|1.15|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.15|0.69|0.36
70992928|NCT05373706|141494091|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.05||||0.73|TWO_SIDED|95.0|0.8|1.38|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.38|0.80|0.73
70992929|NCT05373706|141494092|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|0.83||||0.11|TWO_SIDED|95.0|0.66|1.04|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.04|0.66|0.11
70992930|NCT05373706|141494092|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|0.88||||0.38|TWO_SIDED|95.0|0.66|1.17|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.17|0.66|0.38
70992931|NCT02841787|141494093|SUPERIORITY||||||<|0.001||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||< .001
70992932|NCT02841787|141494093|SUPERIORITY||||||<|0.001||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||<.001
70992933|NCT02841787|141494093|SUPERIORITY|||||||0.44||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||0.44
70992934|NCT02841787|141494093|SUPERIORITY|||||||0.03||||||The threshold for significance was alpha=0.05.|ANOVA|||||||0.03
70992935|NCT02841787|141494093|SUPERIORITY|||||||0.68||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||0.68
70992936|NCT02841787|141494093|SUPERIORITY|||||||0.02||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||0.02
70992937|NCT02841787|141494093|SUPERIORITY|||||||0.03||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||0.03
70992938|NCT02841787|141494096|SUPERIORITY|||||||0.003||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||0.003
70992939|NCT02951988|141494126|SUPERIORITY|||||||0.5305|||||||Log Rank|||||||0.5305
70992940|NCT02951988|141494126|SUPERIORITY|||||||0.4628|||||||Log Rank|||||||0.4628
70992941|NCT02951988|141494127|SUPERIORITY|||||||0.6153|||||||Log Rank|||||||0.6153
70992942|NCT02951988|141494127|SUPERIORITY|||||||0.4123|||||||Log Rank|||||||0.4123
70992943|NCT05836818|141494129|SUPERIORITY||Adjusted difference|25.1|||<|0.0001|TWO_SIDED|95.0|17.0|33.2|||Regression, Logistic|Mixed effects logistic regression with a random center effect for within-center characteristics, and terms for calendar time and intervention||Adjusted difference 25.1 percentage points||33.2|17|<0.0001
70992944|NCT03977727|141494133|SUPERIORITY||Mean Difference (Final Values)|27.35||||0.008|TWO_SIDED|95.0|7.88|48.4|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||48.4|7.88|.008
71039774|NCT01139762|141587524|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34||||0.107|TWO_SIDED|95.0|-0.75|0.07||P-value is for IPSS storage (irritative) subscore - 26 weeks|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.07|-0.75|0.107
71039775|NCT01139762|141587524|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.18|||<|0.001|TWO_SIDED|95.0|-1.69|-0.68||P-value is for IPSS voiding (obstructive) subscore - 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.68|-1.69|<0.001
70992945|NCT03977727|141494134|SUPERIORITY||Mean Difference (Final Values)|15.22||||0.136|TWO_SIDED|95.0|-5.42|39.46|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||39.46|-5.42|.136
70992946|NCT03977727|141494135|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.029|TWO_SIDED|95.0|0.05|0.73|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||.73|.05|.029
70992947|NCT03977727|141494136|SUPERIORITY||Mean Difference (Final Values)|-1.81||||0.016|TWO_SIDED|95.0|-2.84|-0.31|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||-0.31|-2.84|.016
70992948|NCT03977727|141494137|SUPERIORITY||Mean Difference (Final Values)|1.38||||0.045|TWO_SIDED|95.0|0.04|2.32|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||2.32|.04|.045
70992949|NCT03977727|141494140|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.303|TWO_SIDED|95.0|-0.59|0.16|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||.16|-.59|.303
70992950|NCT03977727|141494141|SUPERIORITY||Mean Difference (Final Values)|-1.18||||0.968|TWO_SIDED|95.0|-10.32|9.99|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||9.99|-10.32|.968
70992951|NCT03977727|141494142|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.059|TWO_SIDED|95.0|-0.13|0.0|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||0|-.13|.059
70992952|NCT01627067|141494185|NON_INFERIORITY|The study terminated early due to lack of efficacy and funds only 22 patients were enrolled in the study. With 40 patients accrued at a rate of 2 patients per month, a one-sided alpha of 5%, and a post- accrual follow up of 3 months, we would have 80% power to detect a median PFS of 12 months as being statistically significantly higher than a historical control median PFS of 7 months.|Cox Proportional Hazard|0.25||||0.015|TWO_SIDED|95.0|0.08|0.76|||Regression, Cox|||Data for PFS were censored at the time of a patient's removal from study. With 40 patients accrued at a rate of 2 patients per month, a one-sided alpha of 5%, and a post- accrual follow up of 3 months, we would have 80% power to detect a median PFS of 12 months as being statistically significantly higher than a historical control median PFS of 7 months. The study terminated early due to lack of efficacy and funds only 22 patients were enrolled in the study.||0.76|0.08|0.015
70992953|NCT01627067|141494188|OTHER||Hazard Ratio (HR)|0.6||||0.31|TWO_SIDED|95.0|0.22|1.62|||Regression, Cox|||||1.62|0.22|0.31
70992954|NCT00711269|141494189|SUPERIORITY|One-way Analysis of Variance (ANOVA)|LS Mean difference|-3.5||||0.149|TWO_SIDED|95.0|-8.4|1.3|||ANOVA||\[Not specified\]|||1.3|-8.4|0.149
70992955|NCT00711269|141494189|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-1.8||||0.462|TWO_SIDED|95.0|-6.6|3.0|||ANOVA|||||3.0|-6.6|0.462
70992956|NCT00711269|141494189|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-4.6||||0.122|TWO_SIDED|95.0|-10.5|1.2|||ANOVA|||||1.2|-10.5|0.122
70992957|NCT00711269|141494189|SUPERIORITY|Maximum Contrast Method||||||0.235||||||Contrast Factors (Placebo, SM-13496 40-mg, SM-13496 80-mg): (-1, 0, 1) Adjusted P Value: 0.298|Maximum Contrast Method|Contrast (Placebo, SM-13496 40-mg, SM-13496 80-mg):(-2, 1, 1) Raw P Value: 0.108 Adjusted P Value: 0.145||||||0.235
70992958|NCT00711269|141494190|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-1.4||||0.069|TWO_SIDED|95.0|-2.9|0.1|||ANOVA|||||0.1|-2.9|0.069
70923375|NCT03052608|141338192|SUPERIORITY||Mean Difference (Net)|4.65||||0.0096|TWO_SIDED|95.0|1.14|8.16|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Global QOL. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||8.16|1.14|0.0096
71039776|NCT01139762|141587524|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.04|||<|0.001|TWO_SIDED|95.0|-1.62|-0.46||P-value is for IPSS voiding (obstructive) subscore - 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.46|-1.62|<0.001
70992959|NCT00711269|141494190|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-0.8||||0.287|TWO_SIDED|95.0|-2.3|0.7|||ANOVA|||||0.7|-2.3|0.287
70992960|NCT00711269|141494190|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-2.3||||0.016|TWO_SIDED|95.0|-4.1|-0.4|||ANOVA|||||-0.4|-4.1|0.016
70992961|NCT00711269|141494191|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-0.7||||0.289|TWO_SIDED|95.0|-2.0|0.6|||ANOVA|||||0.6|-2.0|0.289
70992962|NCT00711269|141494191|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-0.7||||0.256|TWO_SIDED|95.0|-2.0|0.5|||ANOVA|||||0.5|-2.0|0.256
70992963|NCT00711269|141494191|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-0.7||||0.352|TWO_SIDED|95.0|-2.3|0.8|||ANOVA|||||0.8|-2.3|0.352
70992964|NCT00711269|141494192|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-1.4||||0.251|TWO_SIDED|95.0|-3.9|1.0|||ANOVA|||||1.0|-3.9|0.251
70992965|NCT00711269|141494192|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-0.2||||0.847|TWO_SIDED|95.0|-2.7|2.2|||ANOVA|||||2.2|-2.7|0.847
70992966|NCT00711269|141494192|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-1.6||||0.292|TWO_SIDED|95.0|-4.6|1.4|||ANOVA|||||1.4|-4.6|0.292
70992967|NCT00926796|141494197|SUPERIORITY_OR_OTHER||Proportion of cured participants|100.0|||<|0.05|ONE_SIDED|95.0|98.53||||Exact binomial confidence limit|If the one-sided lower 95% confidence limit is greater than 95%, the null hypothesis of the microbiological efficacy estimate is \<95% is rejected.|When the lower 95% confidence limit is \>=95%, the alternative hypothesis is accepted (i.e., the microbiological cure estimate is significantly \>=95%).|The null hypothesis is that the microbiological efficacy estimate (proportion of participants who are cured) is \<95%.|||98.53|<0.05
70992968|NCT00926796|141494204|SUPERIORITY_OR_OTHER||Proportion of cured participants|99.5|||<|0.05|ONE_SIDED|95.0|97.64||||Exact bionomial confidence limit|If the one-sided lower 95% confidence limit is greater than 95%, the null hypothesis of the microbiological efficacy estimate is \<95% is rejected.|When the lower 95% confidence interval is above 95%, the alternative hypothesis is accepted (i.e., the microbiological cure estimate is significantly \>=95%).|The null hypothesis is that the microbiological efficacy estimate (proportion of participants who are cured) is \<95%.|||97.64|<0.05
71039777|NCT01139762|141587524|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.73||||0.015|TWO_SIDED|95.0|-1.32|-0.14||P-value is IPSS voiding (obstructive) subscore - 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.14|-1.32|0.015
71099077|NCT05259722|141706939|SUPERIORITY||Mean Difference (Net)|14.3|||<|0.001|TWO_SIDED|95.0|5.81|22.86|||ANCOVA|||The AUC was analysed using a robust ANCOVA model with effects of treatment group, hyperkeratotic/non-hyperkeratotic subtype and baseline value of the score. Missing data was imputed as non-response. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||22.86|5.81|<0.001
70992969|NCT01628016|141494206|OTHER||Mean Difference (Final Values)|3.98||||0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||.05
70992970|NCT01341652|141494208|OTHER|||||||0.97|||||||Mantel Haenszel|||||||0.97
70992971|NCT01341652|141494209|SUPERIORITY|||||||0.08|||||||Wilcoxon Rank Sum test|||||||.08
70992972|NCT01341652|141494211|OTHER||Hazard Ratio (HR)|1.6||||0.14|TWO_SIDED|95.0|0.9|2.8|||Regression, Cox|||||2.8|0.9|0.14
70992973|NCT03483506|141494261|OTHER||Geometric mean ratio|8.34|STANDARD_DEVIATION|50.5|||TWO_SIDED|90.0|5.88|11.82|||ANOVA||"Standard deviation is actually intra individual geometric coefficient of variation. BI 1467335 tab arm is the numerator, while BI 1467335 (C-14) iv arm is the denominator."|The statistical model used for the analysis of the primary PK endpoints was an ANOVA (analysis of variance) model on the logarithmic scale. The model included effects accounting for 'subject' and 'formulation' as sources of variation; 'subject' was considered as a random effect, whereas 'formulation' was considered as a fixed effect.||11.82|5.88|
70992974|NCT03483506|141494263|OTHER||Geometric mean ratio|62.14|STANDARD_DEVIATION|24.4|||TWO_SIDED|90.0|52.08|74.14|||ANOVA||"Standard deviation is actually intra individual geometric coefficient of variation. BI 1467335 tab arm is the numerator, while BI 1467335 (C-14) iv arm is the denominator."|The statistical model used for the analysis of the primary PK endpoints was an ANOVA (analysis of variance) model on the logarithmic scale. The model included effects accounting for 'subject' and 'formulation' as sources of variation; 'subject' was considered as a random effect, whereas 'formulation' was considered as a fixed effect.||74.14|52.08|
70992975|NCT04146467|141494279|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
70992976|NCT04146467|141494281|SUPERIORITY||||||<|0.0004|||||||Fisher Exact|||||||<0.0004
70992977|NCT04146467|141494289|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
70992978|NCT00621855|141494301|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Armitage test for linear trend|||"The proportion of patients who reach this endpoint were analysed by a logistic model for linear trend (dose response).~The null hypothesis is that the relationship between dose level (0mg, 50mg, 75mg, 110mg and 150mg) and the proportions of patients with major and clinically relevant minor bleeding is not linear (slope parameter = 0)"||||<0.001
71099078|NCT05259722|141706940|SUPERIORITY||Mean Difference (Net)|334.0|||<|0.001|TWO_SIDED|95.0|195.69|472.26|||ANCOVA|||The AUC was analysed using a robust ANCOVA model with effects of treatment group, hyperkeratotic/non-hyperkeratotic subtype and baseline value of the score. Missing data was imputed with WOCF. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||472.26|195.69|<0.001
71099079|NCT05259722|141706941|SUPERIORITY||Mean Difference (Net)|-24.5|||<|0.001|TWO_SIDED|95.0|-32.55|-16.36|||ANCOVA|||The change from baseline was analysed using an ANCOVA model with effects of treatment group, hyperkeratotic/non-hyperkeratotic subtype and baseline value of the score. Missing data was imputed with WOCF. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||-16.36|-32.55|<0.001
71099080|NCT02539394|141706952|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.394|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Burden is the same across the 2 arms||||0.394
70992979|NCT00621855|141494304|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Armitage test for linear trend|||"The proportion of patients who reach this endpoint were analysed by a logistic model for linear trend (dose response).~The null hypothesis is that the relationship between dose level (0mg, 50mg, 75mg, 110mg and 150mg) and the proportions of patients with major and clinically relevant minor bleeding is not linear (slope parameter = 0)"||||<0.001
70992980|NCT03731364|141494308|SUPERIORITY|||||||0.276|||||||ANOVA|||||||0.276
70992981|NCT03731364|141494308|SUPERIORITY|||||||0.651|||||||ANOVA|||||||0.651
71099081|NCT02539394|141706952|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.017|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Burden is the same across the 2 arms||||0.017
71099082|NCT02539394|141706952|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.015|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Burden is the same across the 2 arms||||0.015
70992982|NCT03731364|141494308|SUPERIORITY|||||||0.556|||||||ANOVA|||||||0.556
70992983|NCT03731364|141494309|SUPERIORITY|||||||0.136|||||||Wilcoxon (Mann-Whitney)|||||||0.136
70992984|NCT03731364|141494309|SUPERIORITY|||||||0.649|||||||Wilcoxon (Mann-Whitney)|||||||0.649
70992985|NCT03731364|141494309|SUPERIORITY|||||||0.608|||||||Wilcoxon (Mann-Whitney)|||||||0.608
70992986|NCT03731364|141494310|SUPERIORITY||Odds Ratio (OR)|0.0||||0|TWO_SIDED|||||Not estimable|Regression, Logistic|Not estimable|Not estimable|Not estimable||||0
70992987|NCT03731364|141494310|SUPERIORITY||Odds Ratio (OR)|0.0||||0|TWO_SIDED|||||Not estimable|Regression, Logistic|Not estimable|Not estimable|Not estimable||||0
70992988|NCT03731364|141494310|SUPERIORITY||Odds Ratio (OR)|0.0||||0|TWO_SIDED|||||Not estimable|Regression, Logistic||Not estimable|Not estimable||||0
70992989|NCT03731364|141494311|SUPERIORITY|||||||0.306|||||||ANOVA|||||||0.306
71099083|NCT02539394|141706952|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.125|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Burden is the same across the 2 arms||||0.125
71099084|NCT02539394|141706953|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.043|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Eating desire is the same across the 2 arms||||0.043
71099085|NCT02539394|141706953|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.606|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Eating desire is the same across the 2 arms||||0.606
71099086|NCT02539394|141706953|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.155|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Eating desire is the same across the 2 arms||||0.155
70992990|NCT03731364|141494311|SUPERIORITY|||||||0.595|||||||ANOVA|||||||0.595
70992991|NCT03731364|141494311|SUPERIORITY|||||||0.242|||||||ANOVA|||||||0.242
70992992|NCT01934192|141494312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|STANDARD_ERROR_OF_MEAN|7.02|||TWO_SIDED|95.0|-5.1|22.9||||||||22.9|-5.1|
70992993|NCT01934192|141494313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|4.35|||TWO_SIDED|95.0|-6.5|10.9||||||||10.9|-6.5|
70992994|NCT01934192|141494314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|STANDARD_ERROR_OF_MEAN|7.03|||TWO_SIDED|95.0|-5.1|22.9||||||||22.9|-5.1|
70992995|NCT01934192|141494315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.5|STANDARD_ERROR_OF_MEAN|6.74|||TWO_SIDED|95.0|-6.9|19.9||||||||19.9|-6.9|
70992996|NCT03095521|141494350|NON_INFERIORITY|two-sided 95% CIs estimation used to confirm non-inferior efficacy in primary endpoint. A non-inferiority conclusion was made relating to the primary parameter only.||||||0.028|TWO_SIDED|95.0|||||Fisher Exact|||Arm Angal, Arm Antiangin||||0.028
70992997|NCT03095521|141494353|SUPERIORITY|||||||0.482|||||||Wilcoxon (Mann-Whitney)|||||||0.482
70992998|NCT03095521|141494355|SUPERIORITY|||||||0.072|||||||t-test, 2 sided|||change from baseline, 2 groups||||0.072
70992999|NCT03259490|141494356|OTHER||Adjusted gmean ratio T/R (%)|103.06|STANDARD_DEVIATION|5.8|||TWO_SIDED|95.0|100.36|105.83|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||105.83|100.36|
70993000|NCT03259490|141494357|OTHER||Adjusted gmean ratio T/R (%)|100.35|STANDARD_DEVIATION|9.5|||TWO_SIDED|95.0|96.11|104.77|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||104.77|96.11|
70993001|NCT03259490|141494358|OTHER||Adjusted gmean ratio T/R (%)|100.31|STANDARD_DEVIATION|8.2|||TWO_SIDED|95.0|96.65|104.1|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||104.10|96.65|
70993002|NCT03259490|141494359|OTHER||Adjusted gmean ratio T/R (%)|99.95|STANDARD_DEVIATION|12.4|||TWO_SIDED|95.0|94.52|105.7|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||105.70|94.52|
70993003|NCT03259490|141494360|OTHER||Adjusted gmean ratio T/R (%)|107.78|STANDARD_DEVIATION|11.0|||TWO_SIDED|95.0|102.52|113.31|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||113.31|102.52|
70993004|NCT03259490|141494361|OTHER||Adjusted gmean ratio T/R (%)|97.17|STANDARD_DEVIATION|10.6|||TWO_SIDED|95.0|92.63|101.93|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||101.93|92.63|
70993005|NCT03259490|141494362|OTHER||Adjusted gmean ratio T/R (%)|103.11|STANDARD_DEVIATION|5.9|||TWO_SIDED|95.0|100.38|105.92|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||105.92|100.38|
70993006|NCT03259490|141494363|OTHER||Adjusted gmean ratio T/R (%)|100.17|STANDARD_DEVIATION|10.1|||TWO_SIDED|95.0|95.68|104.86|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||104.86|95.68|
70993007|NCT03259490|141494364|OTHER||Adjusted gmean ratio T/R (%)|97.3|STANDARD_DEVIATION|13.2|||TWO_SIDED|95.0|91.65|103.29|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||103.29|91.65|
70993008|NCT01963208|141494365|OTHER||Median Difference (Final Values)|-7.06||||0.1788|TWO_SIDED|95.0|-17.44|3.52||The null hypothesis is that there is no difference between the distributions of the two treatment groups with respect to percent change in seizure frequency.|Rank ANCOVA|||||3.52|-17.44|0.1788
70993009|NCT03260205|141494431|SUPERIORITY||Difference in Least Square Mean|-5.9||||0.0242|TWO_SIDED|95.0|-11.01|-0.78|||MMRM|||This outcome measure was analyzed using the linear mixed-effects model for repeated measures (MMRM). From a MMRM analysis over all post-baseline visits, with the change from baseline in ADHD-RS-IV preschool version total score as the outcome, treatment, visit, and treatment-by-visit interaction as fixed effect, baseline ADHD-RS-IV and baseline ADHD-RS-IV score-by-visit interaction as covariates.||-0.78|-11.01|0.0242
70993010|NCT03260205|141494432|SUPERIORITY||Difference in Least Mean Square|-0.6||||0.0074|TWO_SIDED|95.0|-1.03|-0.16|||MMRM|||This outcome measure was analyzed using the linear mixed-effects model for repeated measures (MMRM). From a MMRM analysis over all post-baseline Visits, with the CGI-I score as the outcome, treatment, visit, and treatment-by-visit interaction as fixed effect, baseline CGI-S as covariate.||-0.16|-1.03|0.0074
70993011|NCT05301322|141494449|NON_INFERIORITY|Noninferiority was declared if the lower limit of the 2-sided 95% CI for the GMR (Coadministration Group to Sequential-Administration Group) was greater than 0.667 for both RSV A and RSV B NTs.|GMR|0.86|||||TWO_SIDED|95.0|0.785|0.951|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Coadministration minus Sequential-Administration) and the corresponding CIs (based on Student's t distribution).|RSV A||0.951|0.785|
70993012|NCT05301322|141494449|NON_INFERIORITY|Noninferiority was declared if the lower limit of the 2-sided 95% CI for the GMR (Coadministration Group to Sequential-Administration Group) was greater than 0.667 for both RSV A and RSV B NTs.|GMR|0.85|||||TWO_SIDED|95.0|0.766|0.943|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Coadministration minus Sequential-Administration) and the corresponding CIs (based on Student's t distribution).|RSV B||0.943|0.766|
70993013|NCT05301322|141494450|NON_INFERIORITY|Noninferiority was declared if the lower limit of the 2-sided 95% CI for the GMR (Coadministration Group to Sequential-Administration Group) was greater than 0.667 for each of the 4 influenza strains.|GMR|0.86|||||TWO_SIDED|95.0|0.769|0.963|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Coadministration minus Sequential-Administration) and the corresponding CIs (based on Student's t distribution).|HAI: H1N1 A/Victoria||0.963|0.769|
70993014|NCT05301322|141494450|NON_INFERIORITY|Noninferiority was declared if the lower limit of the 2-sided 95% CI for the GMR (Coadministration Group to Sequential-Administration Group) was greater than 0.667 for each of the 4 influenza strains.|GMR|0.77|||||TWO_SIDED|95.0|0.68|0.866|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Coadministration minus Sequential-Administration) and the corresponding CIs (based on Student's t distribution).|HAI: H3N2 A/Darwin||0.866|0.680|
71039778|NCT01139762|141587525|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32|||<|0.001|TWO_SIDED|95.0|-0.5|-0.14||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.14|-0.50|<0.001
71039779|NCT01139762|141587525|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.051|TWO_SIDED|95.0|-0.38|0.0||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.00|-0.38|0.051
71039780|NCT01139762|141587525|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17||||0.107|TWO_SIDED|95.0|-0.38|0.04||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.04|-0.38|0.107
70993015|NCT05301322|141494450|NON_INFERIORITY|Noninferiority was declared if the lower limit of the 2-sided 95% CI for the GMR (Coadministration Group to Sequential-Administration Group) was greater than 0.667 for each of the 4 influenza strains.|GMR|0.9|||||TWO_SIDED|95.0|0.789|1.019|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Coadministration minus Sequential-Administration) and the corresponding CIs (based on Student's t distribution).|HAI: B/Austria||1.019|0.789|
70993016|NCT05301322|141494450|NON_INFERIORITY|Noninferiority was declared if the lower limit of the 2-sided 95% CI for the GMR (Coadministration Group to Sequential-Administration Group) was greater than 0.667 for each of the 4 influenza strains.|GMR|0.87|||||TWO_SIDED|95.0|0.779|0.964|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Coadministration minus Sequential-Administration) and the corresponding CIs (based on Student's t distribution).|HAI: B/Phuket||0.964|0.779|
70993017|NCT03829332|141494464|OTHER||Hazard Ratio (HR)|0.78||||0.00624|TWO_SIDED|95.0|0.64|0.95|||Stratified Log Rank|One-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||Hazards ratio (HR) and 95% confidence interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).||0.95|0.64|0.00624
70993018|NCT03829332|141494465|OTHER||Hazard Ratio (HR)|1.1||||0.79744|TWO_SIDED|95.0|0.87|1.39|||Stratified Log Rank|One-sided p-value based on log-rank test stratified by ECOG, region, and baseline PD-L1 status.||HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).||1.39|0.87|0.79744
71039781|NCT01139762|141587526|SUPERIORITY_OR_OTHER||LS Mean Difference|4.85|||<|0.001|TWO_SIDED|95.0|3.49|6.21||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||6.21|3.49|<0.001
71039782|NCT01139762|141587526|SUPERIORITY_OR_OTHER||LS Mean Difference|4.08|||<|0.001|TWO_SIDED|95.0|2.55|5.6||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||5.60|2.55|<0.001
71039783|NCT01139762|141587526|SUPERIORITY_OR_OTHER||LS Mean Difference|4.73|||<|0.001|TWO_SIDED|95.0|3.15|6.31||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||6.31|3.15|<0.001
71039784|NCT01139762|141587527|SUPERIORITY_OR_OTHER||LS Mean Difference|1.01|||<|0.001|TWO_SIDED|95.0|0.61|1.4||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.40|0.61|<0.001
70993019|NCT03829332|141494466|OTHER||Percent Difference|12.8||||0.00037|TWO_SIDED|95.0|5.4|20.1|||Stratified Miettinen & Nurminen|One-sided p-value for testing. H0: difference in percent = 0 versus H1: difference in percent \> 0.||Percent difference and 95% CI were calculated using Miettinen \& Nurminen method stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).||20.1|5.4|0.00037
70993020|NCT03829332|141494469|OTHER|Difference in LS means and 95% CI were calculated using the Constrained longitudinal data analysis (cLDA) model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in Least Square (LS) Means|-3.9||||0.0262|TWO_SIDED|95.0|-7.34|-0.47|||Constrained longitudinal data analysis|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG, region \& baseline PDL-1.||||-0.47|-7.34|0.0262
71039785|NCT01139762|141587527|SUPERIORITY_OR_OTHER||LS Mean Difference|1.06|||<|0.001|TWO_SIDED|95.0|0.61|1.51||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.51|0.61|<0.001
71099087|NCT02539394|141706953|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.019|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Eating desire is the same across the 2 arms||||0.019
71099088|NCT02539394|141706954|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.25|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Eating duration is the same across the 2 arms||||0.250
71099089|NCT02539394|141706954|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.478|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Eating duration is the same across the 2 arms||||0.478
71099090|NCT02539394|141706954|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.019|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Eating duration is the same across the 2 arms||||0.019
71099091|NCT02539394|141706954|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.049|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Eating duration is the same across the 2 arms||||0.049
71099092|NCT02539394|141706955|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.376|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Food selection is the same across the 2 arms||||0.376
71099093|NCT02539394|141706955|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.013|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Food selection is the same across the 2 arms||||0.013
71099094|NCT02539394|141706955|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.049|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Food selection is the same across the 2 arms||||0.049
71099095|NCT02539394|141706955|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.3|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Food selection is the same across the 2 arms||||0.300
71099096|NCT02539394|141706956|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.037|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Communication is the same across the 2 arms||||0.037
70993021|NCT03829332|141494470|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS means|-4.5||||0.0461|TWO_SIDED|95.0|-8.91|-0.08||Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG, region \& baseline PDL-1.|cLDA model|||||-0.08|-8.91|0.0461
70993022|NCT03829332|141494471|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS means|-1.1||||0.5596|TWO_SIDED|95.0|-4.78|2.59|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG, region \& baseline PDL-1.||||2.59|-4.78|0.5596
71099097|NCT02539394|141706956|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.858|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Communication is the same across the 2 arms||||0.858
71099098|NCT02539394|141706956|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.042|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Communication is the same across the 2 arms||||0.042
71099099|NCT02539394|141706956|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.031|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Communication is the same across the 2 arms||||0.031
71099100|NCT02539394|141706957|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.343|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Fear swallow is the same across the 2 arms||||0.343
71099101|NCT02539394|141706957|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.022|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Fear swallow is the same across the 2 arms||||0.022
70993023|NCT03829332|141494472|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS means|-0.88||||0.7088|TWO_SIDED|95.0|-5.49|3.74|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG, region \& baseline PDL-1.||||3.74|-5.49|0.7088
70993024|NCT03829332|141494473|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS means|-3.01||||0.1116|TWO_SIDED|95.0|-6.71|0.7|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG, region \& baseline PDL-1.||||0.70|-6.71|0.1116
70993025|NCT03829332|141494474|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Hazard Ratio (HR)|1.0||||0.9601|TWO_SIDED|95.0|0.75|1.33|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||||1.33|0.75|0.9601
70993026|NCT03829332|141494475|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Hazard Ratio (HR)|0.61||||0.0079|TWO_SIDED|95.0|0.42|0.88|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||||0.88|0.42|0.0079
70993027|NCT03829332|141494476|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Hazard Ratio (HR)|1.06||||0.7457|TWO_SIDED|95.0|0.73|1.56|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||||1.56|0.73|0.7457
70993028|NCT03829332|141494477|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Hazard Ratio (HR)|1.04||||0.8122|TWO_SIDED|95.0|0.75|1.44|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||||1.44|0.75|0.8122
71099102|NCT02539394|141706957|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.018|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Fear swallow is the same across the 2 arms||||0.018
71099103|NCT02539394|141706957|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.008|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Fear swallow is the same across the 2 arms||||0.008
71099104|NCT02539394|141706958|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.28|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Social is the same across the 2 arms||||0.280
71099105|NCT02539394|141706958|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.483|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Social is the same across the 2 arms||||0.483
71099106|NCT02539394|141706958|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.07|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Social is the same across the 2 arms||||0.070
71099107|NCT02539394|141706958|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.2|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Social is the same across the 2 arms||||0.200
70993029|NCT03829332|141494478|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Hazard Ratio (HR)|1.24||||0.148|TWO_SIDED|95.0|0.92|1.67|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||||1.67|0.92|0.1480
70993030|NCT03829332|141494479|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Hazard Ratio (HR)|1.31||||0.4068|TWO_SIDED|95.0|0.7|2.46|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||||2.46|0.70|0.4068
70993031|NCT02198651|141494492|OTHER|||||||0.943|||||||Wald Chi|||||||0.943
70993032|NCT02198651|141494493|OTHER|||||||0.592|||||||Wald Chi|||||||0.592
70993033|NCT02198651|141494494|OTHER|||||||0.688|||||||Wald Chi|||||||0.688
70993034|NCT02115113|141494532|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.24|STANDARD_ERROR_OF_MEAN|5.01||0.3013|TWO_SIDED|95.0|-4.86|15.34|||ANOVA|||||15.34|-4.86|0.3013
70993035|NCT02622724|141494535|SUPERIORITY|||||||0.8219|||||||Van Elteren hypothesis test|||A non-parametric analysis has been used as the data distribution was skewed. This involved a generalised Wilcoxon rank sum-based stratification test which assigns ranks within strata and compares two treatments within strata (Van Elteren hypothesis test).||||0.8219
70993036|NCT02622724|141494542|SUPERIORITY|||||||0.4678|||||||Van Elteren p-values|||Van Elteren hypothesis test was used as the distribution was non-normal and negatively skewed by patients who are assigned scores of zero in the event of death.||||0.4678
70993037|NCT02622724|141494547|SUPERIORITY||||||<|0.05|||||||ANCOVA|Analysis of covariance (ANCOVA) model using Type III sums of squares with Treatment, Severity, and Country fixed effect factors, Baseline as covariate||||||<0.05
70993038|NCT02622724|141494550|OTHER||Least Squares Mean|31.1|||>|0.05|TWO_SIDED|95.0|-37.7|99.9|||ANOVA|||Treatment effect was analysed using ANOVA parameter estimates (Least Squares Means and 95% Confidence Intervals) for the overall treatment difference for maximum distance walked on Day 180.||99.9|-37.7|>0.05
70993039|NCT02622724|141494564|OTHER||LS Means difference|0.0|||>|0.05|ONE_SIDED||||||ANCOVA|ANCOVA estimates (LS means and a 95 % CI for the treatment difference) were presented for all numeric biomarker variables.||IL -1ra - changes in levels from baseline to Day 14||||>0.05
70993040|NCT02622724|141494564|OTHER||LS Means difference|0.0|||>|0.05|ONE_SIDED||||||ANCOVA|ANCOVA estimates (LS means and a 95 % CI for the treatment difference) were presented for all numeric biomarker variables.||IL- 6 - changes in levels from baseline to Day 14||||>0.05
70993041|NCT02622724|141494564|OTHER||LS Means difference|0.0|||<|0.05|ONE_SIDED|95.0|||||ANCOVA|ANCOVA estimates (LS means and a 95% CI for the treatment difference) were presented for all numeric biomarker variables.||FGF basic - changes in levels from baseline to Day 14||||<0.05
70993042|NCT02622724|141494564|OTHER||LS Means difference|0.0|||<|0.05|ONE_SIDED||||||ANCOVA|ANCOVA estimates (LS means and a 95 % CI for the treatment difference) were presented for all numeric biomarker variables.||IP-10 - changes in levels from baseline to Day 14.||||<0.05
70993043|NCT02622724|141494564|OTHER||LS Means difference|0.0|||>|0.05|ONE_SIDED||||||ANCOVA|ANCOVA estimates (LS means and a 95 % CI for the treatment difference) were presented for all numeric biomarker variables.||TNF-α - changes in levels from baseline to Day 14||||>0.05
70993044|NCT02622724|141494565|OTHER||||||<|0.007||||||The p-value is not adjusted for multiple comparisons.|Chi-squared|||||||<0.007
70993045|NCT02622724|141494568|OTHER||Least Squares Mean|28.0|||>|0.05|TWO_SIDED|95.0|-54.0|110.1|||ANOVA|||Treatment effect was analysed using ANOVA parameter estimates (Least Squares Means and 95 % Confidence Intervals) for the overall treatment difference for maximun distance walked on Day 360.||110.1|-54|>0.05
70993046|NCT00485589|141494599|NON_INFERIORITY|Pre-specified analysis||||||0.001|||||||Van Elteren's test|||||||0.001
70993047|NCT00485589|141494599|NON_INFERIORITY|Pre-specified analysis||||||0.0033|||||||Van Elteren's test|||||||0.0033
70993048|NCT02924688|141494614|SUPERIORITY||Least Squares Mean Difference|0.096|STANDARD_ERROR_OF_MEAN|0.0222|<|0.001|TWO_SIDED|95.0|0.052|0.139||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study inhaled corticosteroids (ICS) dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||0.139|0.052|<0.001
70993049|NCT02924688|141494614|SUPERIORITY||Least Squares Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.0221|<|0.001|TWO_SIDED|95.0|0.066|0.153||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||0.153|0.066|<0.001
70993050|NCT02924688|141494614|SUPERIORITY||Least Squares Mean Difference|0.082|STANDARD_ERROR_OF_MEAN|0.0221|<|0.001|TWO_SIDED|95.0|0.039|0.125||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||0.125|0.039|<0.001
70993051|NCT02924688|141494614|SUPERIORITY||Least Squares Mean Difference|0.092|STANDARD_ERROR_OF_MEAN|0.022|<|0.001|TWO_SIDED|95.0|0.049|0.135||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||0.135|0.049|<0.001
70993052|NCT02924688|141494615|SUPERIORITY||Rate Ratio|0.97||||0.778|TWO_SIDED|95.0|0.81|1.17||p-value was calculated using Generalized linear model with covariates for age, sex, region, treatment group, stratification by pre-study ICS dosage at screening, and severe asthma exacerbations in the previous year (0, 1, \>=2).|Negative Binomial Model||Treatment policy estimand was assessed, including all on- and post-treatment data.|||1.17|0.81|0.778
71039786|NCT01139762|141587527|SUPERIORITY_OR_OTHER||LS Mean Difference|1.22|||<|0.001|TWO_SIDED|95.0|0.74|1.69||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.69|0.74|<0.001
71039787|NCT01139762|141587528|SUPERIORITY_OR_OTHER||LS Mean Difference|1.82|||<|0.001|TWO_SIDED|95.0|1.18|2.47||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||2.47|1.18|<0.001
71039788|NCT01139762|141587528|SUPERIORITY_OR_OTHER||LS Mean Difference|1.59|||<|0.001|TWO_SIDED|95.0|0.88|2.31||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||2.31|0.88|<0.001
71039789|NCT01139762|141587528|SUPERIORITY_OR_OTHER||LS Mean Difference|1.98|||<|0.001|TWO_SIDED|95.0|1.23|2.73||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||2.73|1.23|<0.001
70993053|NCT02924688|141494615|SUPERIORITY||Rate Ratio|0.87||||0.151|TWO_SIDED|95.0|0.72|1.05||p-value was calculated using Generalized linear model with covariates for age, sex, region, treatment group, stratification by pre-study ICS dosage at screening, and severe asthma exacerbations in the previous year (0, 1, \>=2).|Negative Binomial Model||Treatment policy estimand was assessed, including all on- and post-treatment data.|||1.05|0.72|0.151
70993054|NCT02924688|141494616|SUPERIORITY||Least Squares Mean Difference|0.088|STANDARD_ERROR_OF_MEAN|0.0226|<|0.001|TWO_SIDED|95.0|0.044|0.132||p-value was calculated using Analysis of Covariance (ANCOVA) with covariates of treatment, age, sex, region, Baseline value, and pre-study ICS dosage at screening.|ANCOVA|||||0.132|0.044|<0.001
70993055|NCT02924688|141494616|SUPERIORITY||Least Squares Mean Difference|0.111|STANDARD_ERROR_OF_MEAN|0.0225|<|0.001|TWO_SIDED|95.0|0.067|0.155||p-value was calculated using ANCOVA with covariates of treatment, age, sex, region, Baseline value, and pre-study ICS dosage at screening.|ANCOVA|||||0.155|0.067|<0.001
71039790|NCT01139762|141587529|SUPERIORITY_OR_OTHER||LS Mean Difference|1.53|||<|0.001|TWO_SIDED|95.0|0.92|2.13||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||2.13|0.92|<0.001
71039791|NCT01139762|141587529|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9||||0.006|TWO_SIDED|95.0|0.27|1.54||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.54|0.27|0.006
71039792|NCT01139762|141587529|SUPERIORITY_OR_OTHER||LS Mean Difference|1.07||||0.002|TWO_SIDED|95.0|0.41|1.74||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.74|0.41|0.002
71099108|NCT02539394|141706959|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.148|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Mental is the same across the 2 arms||||0.148
70993056|NCT02924688|141494616|SUPERIORITY||Least Squares Mean Difference|0.088|STANDARD_ERROR_OF_MEAN|0.0225|<|0.001|TWO_SIDED|95.0|0.044|0.132||p-value was calculated using ANCOVA with covariates of treatment, age, sex, region, Baseline value, and pre-study ICS dosage at screening.|ANCOVA|||||0.132|0.044|<0.001
70993057|NCT02924688|141494616|SUPERIORITY||Least Squares Mean Difference|0.118|STANDARD_ERROR_OF_MEAN|0.0224|<|0.001|TWO_SIDED|95.0|0.074|0.162||p-value was calculated using ANCOVA with covariates of treatment, age, sex, region, Baseline value, and pre-study ICS dosage at screening.|ANCOVA|||||0.162|0.074|<0.001
70993058|NCT02924688|141494617|SUPERIORITY||Least Squares Mean Difference|-0.057|STANDARD_ERROR_OF_MEAN|0.034||0.094|TWO_SIDED|95.0|-0.124|0.01||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||0.010|-0.124|0.094
70993059|NCT02924688|141494617|SUPERIORITY||Least Squares Mean Difference|-0.089|STANDARD_ERROR_OF_MEAN|0.0338||0.008|TWO_SIDED|95.0|-0.156|-0.023||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||-0.023|-0.156|0.008
71099109|NCT02539394|141706959|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.04|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Mental is the same across the 2 arms||||0.040
71099110|NCT02539394|141706959|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.042|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Mental is the same across the 2 arms||||0.042
70993060|NCT02924688|141494618|OTHER||Least Squares Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.697||0.115|TWO_SIDED|95.0|-0.27|2.47||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||2.47|-0.27|0.115
70993061|NCT02924688|141494618|OTHER||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.692||0.662|TWO_SIDED|95.0|-1.66|1.05||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||1.05|-1.66|0.662
70993062|NCT02924688|141494619|OTHER||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.185||0.479|TWO_SIDED|95.0|-0.49|0.23||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and 4-weekly period, interaction terms for Baseline value by 4-weekly period and treatment by 4-weekly period.|Mixed Model Repeated Measures|||||0.23|-0.49|0.479
70993063|NCT02924688|141494619|OTHER||Least Squares Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.184||0.023|TWO_SIDED|95.0|-0.78|-0.06||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and 4-weekly period, interaction terms for Baseline value by 4-weekly period and treatment by 4-weekly period.|Mixed Model Repeated Measures|||||-0.06|-0.78|0.023
70993064|NCT02924688|141494622|OTHER||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.75||0.172|TWO_SIDED|95.0|-2.5|0.4||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for SBP|||0.4|-2.5|0.172
70993065|NCT02924688|141494622|OTHER||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.74||0.436|TWO_SIDED|95.0|-2.0|0.9||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for SBP|||0.9|-2.0|0.436
70993066|NCT02924688|141494622|OTHER||Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.75||0.426|TWO_SIDED|95.0|-0.9|2.1||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for SBP|||2.1|-0.9|0.426
70993067|NCT02924688|141494622|OTHER||Least Squares Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.74||0.349|TWO_SIDED|95.0|-0.8|2.2||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for SBP|||2.2|-0.8|0.349
71099111|NCT02539394|141706959|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.319|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Mental is the same across the 2 arms||||0.319
70993068|NCT02924688|141494622|OTHER||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.56||0.482|TWO_SIDED|95.0|-1.5|0.7||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for DBP|||0.7|-1.5|0.482
70993069|NCT02924688|141494622|OTHER||Least Squares Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.56||0.142|TWO_SIDED|95.0|-0.3|1.9||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for DBP|||1.9|-0.3|0.142
70993070|NCT02924688|141494622|OTHER||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.56||0.806|TWO_SIDED|95.0|-1.2|1.0||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for DBP|||1.0|-1.2|0.806
71099112|NCT02539394|141706960|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.161|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Sleep is the same across the 2 arms||||0.161
71099113|NCT02539394|141706960|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.763|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Sleep is the same across the 2 arms||||0.763
71099114|NCT02539394|141706960|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.178|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Sleep is the same across the 2 arms||||0.178
71099115|NCT02539394|141706960|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.091|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Sleep is the same across the 2 arms||||0.091
71099116|NCT02539394|141706961|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.602|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Fatigue is the same across the 2 arms||||0.602
71099117|NCT02539394|141706961|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.302|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Fatigue is the same across the 2 arms||||0.302
71099118|NCT02539394|141706961|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.114|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Fatigue is the same across the 2 arms||||0.114
71099119|NCT02539394|141706961|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.005|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Fatigue is the same across the 2 arms||||0.005
71099120|NCT02539394|141706962|EQUIVALENCE|Two-sided 95% confidence interval||||||0.933|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative Eat-10 is the same across the 2 arms||||0.933
71099121|NCT02539394|141706962|EQUIVALENCE|Two-sided 95% confidence interval||||||0.95|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative modified Eat-10 is the same across the 2 arms||||0.950
70993071|NCT02924688|141494622|OTHER||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.55||0.447|TWO_SIDED|95.0|-0.7|1.5||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for DBP|||1.5|-0.7|0.447
70993072|NCT02924688|141494623|OTHER||Least Squares Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.61||0.034|TWO_SIDED|95.0|0.1|2.5||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||2.5|0.1|0.034
70993073|NCT02924688|141494623|OTHER||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.61||0.839|TWO_SIDED|95.0|-1.1|1.3||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||1.3|-1.1|0.839
70993074|NCT02924688|141494623|OTHER||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.61||0.349|TWO_SIDED|95.0|-1.8|0.6||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||0.6|-1.8|0.349
70993075|NCT02924688|141494623|OTHER||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.61||0.768|TWO_SIDED|95.0|-1.0|1.4||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||1.4|-1.0|0.768
70993076|NCT00174785|141494626|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76|||<|0.0001||95.0|0.69|0.84||Cumulative incidence functions in each treatment group were calculated using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. The primary comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of first hospitalization for cardiovascular reason or death for the dronedarone group compared with the placebo group.|||0.84|0.69|<0.0001
70993077|NCT00174785|141494627|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.18||95.0|0.66|1.08||Cumulative incidences calculated in each group using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. Hierarchical procedure applied to secondary efficacy endpoints testing to protect the global type I error.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of death from any cause for the dronedarone group compared with the placebo group.|||1.08|0.66|0.18
70993078|NCT00174785|141494628|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||<|0.0001||95.0|0.67|0.82||Cumulative incidences calculated in each group using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. Hierarchical procedure applied to secondary efficacy endpoints testing to protect the global type I error.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of first hospitalization for cardiovascular reason for the dronedarone group compared with the placebo group.|||0.82|0.67|<0.0001
70993079|NCT00174785|141494629|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.025||95.0|0.51|0.96||Cumulative incidences calculated in each group using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. Hierarchical procedure applied to secondary efficacy endpoints testing to protect the global type I error.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of cardiovascular death for the dronedarone group compared with the placebo group.|||0.96|0.51|0.025
70993080|NCT00174785|141494630|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.03||95.0|0.51|0.98||Cumulative incidences calculated in each group using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. The comparison was performed at the 5% level using a 2-sided Log rank|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of adjudicated cardiovascular death for the dronedarone group compared with the placebo group.|||0.98|0.51|0.03
70993081|NCT00120289|141494637|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.8|TWO_SIDED|95.0|0.87|1.21|||Regression, Cox|Adjusting for gender and history of diabetes (randomization stratification factors).||||1.21|0.87|0.80
70993082|NCT00120289|141494638|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.49|TWO_SIDED|95.0|0.87|1.34|||Regression, Cox|||||1.34|0.87|.49
70993083|NCT00120289|141494639|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.3|TWO_SIDED|95.0|0.9|1.42|||Regression, Cox|||||1.42|0.90|.30
70993084|NCT00120289|141494640|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.47|TWO_SIDED|95.0|0.76|1.8|||Regression, Cox|||||1.80|0.76|0.47
70993085|NCT00848250|141494693|SUPERIORITY|||||||0.03|||||||ANOVA|||||||0.03
70993086|NCT00848250|141494694|SUPERIORITY|||||||0.13|||||||ANOVA|Repeated measures||||||0.13
70993087|NCT00848250|141494695|SUPERIORITY|||||||0.02|||||||ANOVA|Repeated measures||||||0.02
70993088|NCT00848250|141494696|SUPERIORITY|||||||0.67|||||||ANOVA|Repeated measures||||||0.67
70993089|NCT00848250|141494698|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||P-value is for comparison of chest tube output at 24 hours||||0.47
71099122|NCT02539394|141706962|EQUIVALENCE|Two-sided 95% confidence interval||||||0.059|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 Eat-10 is the same across the 2 arms||||0.059
70993090|NCT00848250|141494699|SUPERIORITY|||||||0.41|||||||Fisher Exact|||||||0.41
70993091|NCT00798694|141494758|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||"Null Hypothesis: There is no significant difference in tear break-up time between the group New to Meds and the group Currently on Xalatan at two months."||||0.005
71099123|NCT02539394|141706962|EQUIVALENCE|Two-sided 95% confidence interval||||||0.042|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 modified Eat-10 is the same across the 2 arms||||0.042
71099124|NCT02539394|141706962|EQUIVALENCE|Two-sided 95% confidence interval||||||0.032|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 Eat-10 is the same across the 2 arms||||0.032
70993092|NCT03546413|141494767|SUPERIORITY||||||<|0.001||||||This is the calculated p-value|Regression, Logistic|||Test for equivalence between the groups||||<0.001
70993093|NCT03546413|141494768|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.055|||||||Regression, Logistic|||Test for equivalence between the groups||||0.055
70993094|NCT03546413|141494769|SUPERIORITY||||||<|0.001||||||This is the calculated p-value|Wilcoxon (Mann-Whitney)|||||||<0.001
70993095|NCT03546413|141494769|SUPERIORITY|A linear regression model was used on the log of the peanut consumption with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.|||||<|0.001||||||This is the calculated p-value|Regression, Linear|||||||<0.001
70993096|NCT03546413|141494769|SUPERIORITY|A linear regression model was used on the log of the peanut consumption with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.939|||||||Regression, Linear|||||||0.939
70993097|NCT03546413|141494769|SUPERIORITY|A linear regression model was used on the log of the peanut consumption with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.||||||0.002|||||||Regression, Linear|||||||0.002
70993098|NCT03546413|141494770|SUPERIORITY|||||||0.131|||||||Wilcoxon (Mann-Whitney)|||||||0.131
70993099|NCT03546413|141494770|SUPERIORITY|A linear regression model was used on the log of peanut skin prick test with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.208|||||||Regression, Linear|||||||0.208
70993100|NCT03546413|141494770|SUPERIORITY|A linear regression model was used on the log of peanut skin prick with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.587|||||||Regression, Linear|||||||0.587
70993101|NCT03546413|141494770|SUPERIORITY|A linear regression model was used on the log of peanut skin prick with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.||||||0.268|||||||Regression, Linear|||||||0.268
70993102|NCT03546413|141494771|SUPERIORITY|||||||0.985|||||||Wilcoxon (Mann-Whitney)|||||||0.985
70993103|NCT03546413|141494771|SUPERIORITY|A linear regression model was used on the log of peanut specific IgE with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.371|||||||Regression, Linear|||||||0.371
70993104|NCT03546413|141494771|SUPERIORITY|A linear regression model was used on the log of peanut specific IgE with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.483|||||||Regression, Linear|||||||0.483
70993105|NCT03546413|141494771|SUPERIORITY|A linear regression model was used on the log of peanut specific IgE with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.||||||0.643|||||||Regression, Linear|||||||0.643
70993106|NCT03546413|141494772|SUPERIORITY|||||||0.225|||||||Wilcoxon (Mann-Whitney)|||||||0.225
70993107|NCT03546413|141494772|SUPERIORITY|A linear regression model was used on the log of SCORAD with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.857|||||||Regression, Linear|||||||0.857
70993108|NCT03546413|141494772|SUPERIORITY|A linear regression model was used on the log of SCORAD with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.87|||||||Regression, Linear|||||||0.870
70993109|NCT03546413|141494773|SUPERIORITY|||||||0.658|||||||Regression, Logistic|||||||0.658
70993110|NCT03546413|141494773|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.1|||||||Regression, Logistic|||||||0.100
71099125|NCT02539394|141706962|EQUIVALENCE|Two-sided 95% confidence interval||||||0.014|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 modified Eat-10 is the same across the 2 arms||||0.014
70993111|NCT03546413|141494773|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.502|||||||Regression, Linear|||||||0.502
70993112|NCT03546413|141494773|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.||||||0.397|||||||Regression, Linear|||||||0.397
70993113|NCT03546413|141494774|SUPERIORITY|||||||0.659|||||||Regression, Logistic|||||||0.659
70993114|NCT03546413|141494774|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.26|||||||Regression, Logistic|||||||0.260
70993115|NCT03546413|141494774|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.075|||||||Regression, Linear|||||||0.075
70993116|NCT03546413|141494774|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.||||||0.192|||||||Regression, Logistic|||||||0.192
70993117|NCT03546413|141494775|SUPERIORITY|||||||0.729|||||||Regression, Logistic|||||||0.729
70993118|NCT03546413|141494775|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.75|||||||Regression, Logistic|||||||0.750
70993119|NCT03546413|141494775|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.155|||||||Regression, Logistic|||||||0.155
70993120|NCT03546413|141494775|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.||||||0.458|||||||Regression, Logistic|||||||0.458
70993121|NCT03546413|141494776|SUPERIORITY|||||||0.33|||||||Regression, Logistic|||||||0.330
71099126|NCT02539394|141706962|EQUIVALENCE|Two-sided 95% confidence interval||||||0.03|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks Eat-10 is the same across the 2 arms||||0.030
70993122|NCT03546413|141494776|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.351|||||||Regression, Logistic|||||||0.351
70923376|NCT03052608|141338192|SUPERIORITY||Mean Difference (Net)|2.02||||0.1897|TWO_SIDED|95.0|-1.01|5.05|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Physical Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||5.05|-1.01|0.1897
70993123|NCT03546413|141494776|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.502|||||||Regression, Logistic|||||||0.502
70993124|NCT03546413|141494776|SUPERIORITY|||||||0.732||||||A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.|Regression, Logistic|||||||0.732
70993125|NCT03546413|141494777|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.202|||||||Regression, Logistic|||||||0.202
70993126|NCT03546413|141494777|OTHER||||||||||||||Regression, Logistic||||A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit. However, the logistic regression model was unable to converge due to the low percentage of allergic participants in older siblings.|||
70993127|NCT03546413|141494777|OTHER||||||||||||||Regression, Logistic||||A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit. However, the logistic regression model was unable to converge due to the low percentage of allergic participants in parents.|||
70993128|NCT03546413|141494778|SUPERIORITY|||||||0.029|||||||Regression, Logistic|||||||0.029
70993129|NCT03546413|141494778|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.489|||||||Regression, Logistic|||||||0.489
70993130|NCT03546413|141494778|OTHER||||||||||||||Regression, Logistic||||A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit. However, the model was unable to converge due to the low percentage of peanut-related adverse events in older siblings.|||
70993131|NCT01089582|141494790|SUPERIORITY_OR_OTHER|||||||0.0023|TWO_SIDED||||||Regression, Logistic|||The effect of possible prognostic factors response on response rate: primary diagnosis severity. Participants were classified as responders if they were very much improved or much improved from baseline.||||0.0023
70993132|NCT01089582|141494791|SUPERIORITY_OR_OTHER|||||||0.0382|TWO_SIDED||||||Regression, Logistic|||The effect of possible prognostic factors on response: significant medical history. Participants were classified as responders if they were much improved or improved from baseline.||||0.0382
70993133|NCT01089582|141494792|SUPERIORITY_OR_OTHER|||||||0.1805|TWO_SIDED||||||Regression, Linear|||The effect of possible prognostic factors on response: primary diagnosis severity.||||0.1805
70993134|NCT01089582|141494792|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Regression, Linear|||The effect of possible prognostic factors on response: baseline QoL-AD score as assessed by participant.||||<0.0001
71039793|NCT01139762|141587530|SUPERIORITY_OR_OTHER||LS Mean Difference|0.93|||<|0.001|TWO_SIDED|95.0|0.61|1.25||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.25|0.61|<0.001
70993135|NCT01089582|141494792|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Regression, Linear|||The effect of possible prognostic factors on response: center number.||||<0.0001
70993136|NCT01089582|141494793|SUPERIORITY_OR_OTHER|||||||0.0137|TWO_SIDED||||||Regression, Linear|||The effect of possible prognostic factors on response: primary diagnosis severity.||||0.0137
70993137|NCT01089582|141494793|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Regression, Linear|||The effect of possible prognostic factors on response: baseline QoL-AD score as assessed by caregiver.||||<0.0001
71099127|NCT02539394|141706962|EQUIVALENCE|Two-sided 95% confidence interval||||||0.039|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks modified Eat-10 is the same across the 2 arms||||0.039
70923377|NCT03052608|141338192|SUPERIORITY||Mean Difference (Net)|2.09||||0.2999|TWO_SIDED|95.0|-1.87|6.04|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Role Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||6.04|-1.87|0.2999
70993138|NCT01089582|141494793|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Regression, Linear|||The effect of possible prognostic factors on response: center number.||||<0.0001
70993139|NCT00862849|141494797|SUPERIORITY_OR_OTHER||LS Mean Difference|26.47|||<|0.0001|TWO_SIDED|90.0|18.22|34.71||Treatment comparison for %AUC(0-30). Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|Mixed Models Analysis|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||34.71|18.22|<0.0001
70993140|NCT00862849|141494797|SUPERIORITY_OR_OTHER||LS Mean Difference|16.7||||0.0015|TWO_SIDED|90.0|8.45|24.94||Treatment comparison for %AUC(0-30). Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|Mixed Models Analysis|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed||||24.94|8.45|0.0015
70993141|NCT03943953|141494805|SUPERIORITY||Mean Difference (Final Values)|2.86||||0.018|TWO_SIDED||||||t-test, 1 sided|||This is a comparison between Time 1 and Time 2||||.018
70993142|NCT03943953|141494807|SUPERIORITY||Mean Difference (Final Values)|3.88||||0.001|TWO_SIDED||||||t-test, 1 sided|||This is a comparison between Time 1 and Time 2||||.001
70993143|NCT03943953|141494809|SUPERIORITY||Mean Difference (Final Values)|3.88||||0.006|TWO_SIDED||||||t-test, 1 sided|||This is a comparison between Time 1 and Time 2||||.006
70993144|NCT03943953|141494811|SUPERIORITY||Mean Difference (Final Values)|-2.28||||0.035|TWO_SIDED||||||t-test, 1 sided|||This is a comparison between Time 1 and Time 2||||.035
70993145|NCT03943953|141494813|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.39|TWO_SIDED||||||t-test, 1 sided|||This is a comparison between Time 1 and Time 2||||.39
71039794|NCT01139762|141587530|SUPERIORITY_OR_OTHER||LS Mean Difference|0.79|||<|0.001|TWO_SIDED|95.0|0.44|1.14||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.14|0.44|<0.001
71039795|NCT01139762|141587530|SUPERIORITY_OR_OTHER||LS Mean Difference|0.76|||<|0.001|TWO_SIDED|95.0|0.39|1.13||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.13|0.39|<0.001
71039796|NCT01139762|141587531|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||P-value is for overall distribution of responses.|Cochran-Mantel-Haenszel|Adjusted for baseline lower urinary tract symptoms (LUTS) severity.||||||0.034
71039797|NCT01139762|141587532|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Van Elteren test|Van Elteren test was stratified by region.||||||0.031
71039798|NCT01139762|141587533|SUPERIORITY_OR_OTHER|||||||0.328||95.0||||P-value is for overall distribution of responses.|Cochran-Mantel-Haenszel|Adjusted for baseline lower urinary tract symptoms (LUTS) severity.||||||0.328
71039799|NCT01139762|141587534|SUPERIORITY_OR_OTHER|||||||0.157||95.0|||||Wilcoxon Rank-Sum test|||||||0.157
70993146|NCT01102218|141494816|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
70993147|NCT02724774|141495013|SUPERIORITY|||||||0.026||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||All analyses were conducted as intention-to-treat, analyzing all 252 cases as randomly assigned to the PFR and control group (CG). Multiple linear regression was used to examine the treatment effect of PFR (0 = CG, 1 = PFR). Covariates included preferred language (0 = English, 1 = Spanish) and the baseline measure.||||.026
71039800|NCT01139762|141587535|SUPERIORITY_OR_OTHER||LS Mean Difference|0.74|||<|0.001|TWO_SIDED|95.0|0.49|0.98||P-value is for Question 3 - 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.98|0.49|<0.001
71039801|NCT01139762|141587535|SUPERIORITY_OR_OTHER||LS Mean Difference|0.68|||<|0.001|TWO_SIDED|95.0|0.43|0.93||P-value is for Question 3 - 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.93|0.43|<0.001
70993148|NCT02724774|141495014|SUPERIORITY|||||||0.154||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||||||.154
71039802|NCT01139762|141587535|SUPERIORITY_OR_OTHER||LS Mean Difference|0.75|||<|0.001|TWO_SIDED|95.0|0.48|1.02||P-value is for Question 3 - 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.02|0.48|<0.001
71039803|NCT01139762|141587535|SUPERIORITY_OR_OTHER||LS Mean Difference|0.71|||<|0.001|TWO_SIDED|95.0|0.46|0.95||P-value is for Question 4 - 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.95|0.46|<0.001
71039804|NCT01139762|141587535|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61|||<|0.001|TWO_SIDED|95.0|0.36|0.85||P-value is for Question 4 - 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.85|0.36|<0.001
71099128|NCT02539394|141706963|EQUIVALENCE|Two-sided||||||0.121|||||||Chi-squared|||Proportion of Pre-operative Bazaz Liquid is the same between the 2 arms||||0.121
71099129|NCT02539394|141706963|EQUIVALENCE|Two-sided||||||0.006|||||||Chi-squared|||Proportion of POD1 Bazaz Liquid is the same between the 2 arms||||0.006
71099130|NCT02539394|141706963|EQUIVALENCE|Two-sided||||||0.329|||||||Chi-squared|||Proportion of POD2 Bazaz Liquid is the same between the 2 arms||||0.329
70993149|NCT02724774|141495015|SUPERIORITY|||||||0.516||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||||||.516
70993150|NCT02724774|141495016|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||||||<0.001
70993151|NCT02724774|141495017|SUPERIORITY|||||||0.094||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||||||0.094
70993152|NCT02724774|141495018|SUPERIORITY|||||||0.029|||||||Regression, Linear|||||||0.029
70993153|NCT02724774|141495019|SUPERIORITY|||||||0.389||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||||||.389
70993154|NCT02724774|141495020|SUPERIORITY|||||||0.747||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||||||.747
70993155|NCT00403559|141495077|NON_INFERIORITY|Non-inferiority determined as the F-IGA, IGA, erythema, scaling, and pruritis scores when compared between groups. The Wilcoxon rank sum test stratified baseline seborrheic dermatitis (SD) severity.||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||.009
70993156|NCT01029886|141495135|NON_INFERIORITY_OR_EQUIVALENCE|Superiority of exenatide once weekly with respect to change in HbA1c was concluded if the upper limit of the 2-sided 95% confidence interval (CI) for the treatment difference (exenatide once weekly minus liraglutide) was less than zero. Non-inferiority was concluded if the upper limit of the CI was \<0.25%.|Least Squares Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED|95.0|0.08|0.33|||Mixed Models Analysis|||A sample of 408 subjects in each treatment arm would provide approximately 90% power to detect a true difference between treatments of 0.25% in change in HbA1c from baseline with a 2 sided t-test at a significance level of 0.05, assuming a common standard deviation of 1.1%. MMRM model includes treatment, baseline HbA1c, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||0.33|0.08|0.002
70993157|NCT01029886|141495136|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Percentage of patients achieving HbA1c \<7.0% at Week 26 were compared between treatments using a Cochran-Mantel-Haenszel test, in which HbA1c stratum, country, and background OAD served as stratification factors.||||0.011
70993158|NCT01029886|141495137|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.15||0.021|TWO_SIDED|95.0|0.05|0.66|||Mixed Models Analysis|||MMRM model includes treatment, baseline fasting serum glucose, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||0.66|0.05|0.021
70993159|NCT01029886|141495138|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|0.39|1.4|||Mixed Models Analysis|||MMRM model includes treatment, baseline body weight, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||1.40|0.39|<.001
70993160|NCT01029886|141495139|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.05||0.079|TWO_SIDED|95.0|-0.01|0.19|||Mixed Models Analysis|||MMRM model includes treatment, baseline total cholesterol, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||0.19|-0.01|0.079
70993161|NCT01029886|141495140|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.832|TWO_SIDED|95.0|-0.02|0.02|||Mixed Models Analysis|||MMRM model includes treatment, baseline HDL-C, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||0.02|-0.02|0.832
70993162|NCT01029886|141495141|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.09|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|1.04|1.15|||Mixed Models Analysis|||Fasting triglycerides were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using a MMRM model with treatment, baseline fasting triglycerides, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||1.15|1.04|<.001
71099131|NCT02539394|141706963|EQUIVALENCE|Two-sided||||||0.687|||||||Chi-squared|||Proportion of 4-6 weeks Bazaz Liquid is the same between the 2 arms||||0.687
71099132|NCT02539394|141706964|EQUIVALENCE|Two-sided||||||0.066|||||||Chi-squared|||Proportion of Pre-operative Bazaz Solid is the same between the 2 arms||||0.066
70993163|NCT01029886|141495142|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.97|STANDARD_ERROR_OF_MEAN|0.76||0.205|TWO_SIDED|95.0|-0.53|2.47|||Mixed Models Analysis|||MMRM model includes treatment, baseline SBP, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||2.47|-0.53|0.205
70993164|NCT01029886|141495143|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.5||0.981|TWO_SIDED|95.0|-0.96|0.98|||Mixed Models Analysis|||MMRM model includes treatment, baseline DBP, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||0.98|-0.96|0.981
70993165|NCT01968954|141495163|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-57.0|STANDARD_ERROR_OF_MEAN|2.0|<|0.001|TWO_SIDED|95.0|-61.0|-53.1|||Mixed Model Repeated Measures (MMRM)|||LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-53.1|-61.0|<0.001
70993166|NCT01968954|141495164|SUPERIORITY_OR_OTHER||LS mean difference|-36.2|STANDARD_ERROR_OF_MEAN|1.33|<|0.001|TWO_SIDED|95.0|-38.8|-33.6|||MMRM|||Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-33.6|-38.8|<0.001
70993167|NCT01968954|141495164|SUPERIORITY_OR_OTHER||LS mean difference|-34.7|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|95.0|-37.7|-31.7||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-31.7|-37.7|
70993168|NCT01968954|141495164|SUPERIORITY_OR_OTHER||LS mean difference|-29.0|STANDARD_ERROR_OF_MEAN|1.69|||TWO_SIDED|95.0|-32.3|-25.7||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-25.7|-32.3|
70993169|NCT01968954|141495165|SUPERIORITY_OR_OTHER||LS mean difference|-51.6|STANDARD_ERROR_OF_MEAN|1.8|<|0.001|TWO_SIDED|95.0|-55.2|-48.1|||MMRM|||Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-48.1|-55.2|<0.001
71099133|NCT02539394|141706964|EQUIVALENCE|Two-sided||||||0.252|||||||Chi-squared|||Proportion of POD1 Bazaz Solid is the same between the 2 arms||||0.252
71099134|NCT02539394|141706964|EQUIVALENCE|Two-sided||||||0.1|||||||Chi-squared|||Proportion of POD2 Bazaz Solid is the same between the 2 arms||||0.100
71099135|NCT02539394|141706964|EQUIVALENCE|Two-sided||||||0.279|||||||Chi-squared|||Proportion of 4-6 weeks Bazaz Solid is the same between the 2 arms||||0.279
70993170|NCT01968954|141495165|SUPERIORITY_OR_OTHER||LS mean Difference|-50.6|STANDARD_ERROR_OF_MEAN|2.15|||TWO_SIDED|95.0|-54.9|-46.4||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-46.4|-54.9|
70993171|NCT01968954|141495165|SUPERIORITY_OR_OTHER||LS mean difference|-41.2|STANDARD_ERROR_OF_MEAN|2.38|||TWO_SIDED|95.0|-45.8|-36.5||||||Week 52:LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-36.5|-45.8|
70993172|NCT01968954|141495166|SUPERIORITY_OR_OTHER||LS mean difference|-51.5|STANDARD_ERROR_OF_MEAN|1.84|<|0.001|TWO_SIDED|95.0|-55.1|-47.9|||MMRM|||Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-47.9|-55.1|<0.001
70993173|NCT01968954|141495166|SUPERIORITY_OR_OTHER||LS mean difference|-50.6|STANDARD_ERROR_OF_MEAN|2.05|||TWO_SIDED|95.0|-54.6|-46.6||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-46.6|-54.6|
70993174|NCT01968954|141495166|SUPERIORITY_OR_OTHER||LS mean difference|-40.8|STANDARD_ERROR_OF_MEAN|2.26|||TWO_SIDED|95.0|-45.2|-36.3||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-36.3|-45.2|
70993175|NCT01968954|141495167|SUPERIORITY_OR_OTHER||LS mean difference|-2.9|STANDARD_ERROR_OF_MEAN|16.55||0.86|TWO_SIDED|95.0|-35.4|29.5|||MMRM|||Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||29.5|-35.4|0.860
70993176|NCT01968954|141495167|SUPERIORITY_OR_OTHER||LS mean difference|2.1|STANDARD_ERROR_OF_MEAN|25.11|||TWO_SIDED|95.0|-47.2|51.4||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||51.4|-47.2|
70993177|NCT01968954|141495167|SUPERIORITY_OR_OTHER||LS mean difference|12.9|STANDARD_ERROR_OF_MEAN|29.25|||TWO_SIDED|95.0|-44.5|70.4||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||70.4|-44.5|
70993178|NCT01968954|141495168|SUPERIORITY_OR_OTHER||LS mean difference|4.7|STANDARD_ERROR_OF_MEAN|1.19|<|0.001|TWO_SIDED|95.0|2.4|7.0|||MMRM|||Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||7.0|2.4|<0.001
70993179|NCT01968954|141495168|SUPERIORITY_OR_OTHER||LS mean difference|6.8|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|95.0|4.5|9.1||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||9.1|4.5|
70993180|NCT01968954|141495168|SUPERIORITY_OR_OTHER||LS mean difference|3.3|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|95.0|0.9|5.8||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||5.8|0.9|
70993181|NCT01968954|141495169|SUPERIORITY_OR_OTHER||LS mean difference|-59.1|STANDARD_ERROR_OF_MEAN|2.19|<|0.001|TWO_SIDED|95.0|-63.4|-54.8|||MMRM|||LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-54.8|-63.4|<0.001
70993182|NCT01968954|141495170|SUPERIORITY_OR_OTHER||LS mean difference|-48.7|STANDARD_ERROR_OF_MEAN|4.72|<|0.001|TWO_SIDED|95.0|-58.0|-39.3|||MMRM|||LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-39.3|-58.0|<0.001
70993183|NCT01968954|141495171|SUPERIORITY_OR_OTHER||LS mean difference|-56.0|STANDARD_ERROR_OF_MEAN|2.45|||TWO_SIDED|95.0|-60.8|-51.2||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-51.2|-60.8|
70993184|NCT01968954|141495171|SUPERIORITY_OR_OTHER||LS mean difference|-46.4|STANDARD_ERROR_OF_MEAN|2.77|||TWO_SIDED|95.0|-51.8|-41.0||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-41.0|-51.8|
70993185|NCT01968954|141495172|SUPERIORITY_OR_OTHER||LS mean difference|-57.6|STANDARD_ERROR_OF_MEAN|2.82|||TWO_SIDED|95.0|-63.1|-52.0||||||TG \<200 mg/dL (Week 24): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region.||-52.0|-63.1|
70993186|NCT01968954|141495172|SUPERIORITY_OR_OTHER||LS mean difference|-47.7|STANDARD_ERROR_OF_MEAN|3.16|||TWO_SIDED|95.0|-53.9|-41.5||||||TG \<200 mg/dL (Week 52): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region.||-41.5|-53.9|
70993187|NCT01968954|141495172|SUPERIORITY_OR_OTHER||LS mean difference|-49.3|STANDARD_ERROR_OF_MEAN|4.83|||TWO_SIDED|95.0|-58.9|-39.8||||||TG \>=200 mg/dL (Week 24): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region.||-39.8|-58.9|
71099136|NCT02539394|141706965|EQUIVALENCE|Two-sided 95% confidence interval||||||0.145|||||||t-test, 2 sided|||The means Pre-operative NDI for the two populations is equal||||0.145
70993188|NCT01968954|141495172|SUPERIORITY_OR_OTHER||LS mean difference|-41.2|STANDARD_ERROR_OF_MEAN|5.6|||TWO_SIDED|95.0|-52.2|-30.1||||||TG \>=200 mg/dL (Week 52): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region.||-30.1|-52.2|
70993189|NCT01968954|141495173|SUPERIORITY_OR_OTHER||LS mean difference|-14.2|STANDARD_ERROR_OF_MEAN|2.88|||TWO_SIDED|95.0|-19.9|-8.5||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-8.5|-19.9|
70993190|NCT01968954|141495173|SUPERIORITY_OR_OTHER||LS mean difference|-19.9|STANDARD_ERROR_OF_MEAN|2.65|||TWO_SIDED|95.0|-25.1|-14.7||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-14.7|-25.1|
70993191|NCT01968954|141495173|SUPERIORITY_OR_OTHER||LS mean difference|-9.2|STANDARD_ERROR_OF_MEAN|3.31|||TWO_SIDED|95.0|-15.7|-2.8||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-2.8|-15.7|
70993192|NCT01968954|141495174|SUPERIORITY_OR_OTHER||LS mean difference|3.7|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|1.8|5.7||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||5.7|1.8|
70993193|NCT01968954|141495174|SUPERIORITY_OR_OTHER||LS mean difference|4.9|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|3.1|6.7||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||6.7|3.1|
70993194|NCT01968954|141495174|SUPERIORITY_OR_OTHER||LS mean difference|2.6|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|95.0|0.7|4.6||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||4.6|0.7|
70993195|NCT01968954|141495175|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.93|||TWO_SIDED|95.0|-1.9|1.7||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||1.7|-1.9|
70993196|NCT01968954|141495175|SUPERIORITY_OR_OTHER||LS mean difference|1.9|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|95.0|-0.1|3.9||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||3.9|-0.1|
70993197|NCT01968954|141495175|SUPERIORITY_OR_OTHER||LS mean difference|1.0|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-1.0|3.1||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||3.1|-1.0|
70993198|NCT01968954|141495176|SUPERIORITY_OR_OTHER||LS-Mean Difference|-14.2|STANDARD_ERROR_OF_MEAN|2.88|||TWO_SIDED|95.0|-19.9|-8.5||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-8.5|-19.9|
70993199|NCT01968954|141495176|SUPERIORITY_OR_OTHER||LS mean difference|-19.9|STANDARD_ERROR_OF_MEAN|2.65|||TWO_SIDED|95.0|-25.1|-14.7||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-14.7|-25.1|
70993200|NCT01968954|141495176|SUPERIORITY_OR_OTHER||LS mean difference|-9.2|STANDARD_ERROR_OF_MEAN|3.31|||TWO_SIDED|95.0|-15.7|-2.8||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-2.8|-15.7|
70993201|NCT01968954|141495177|SUPERIORITY_OR_OTHER||LS mean difference|-64.2|STANDARD_ERROR_OF_MEAN|2.51|||TWO_SIDED|95.0|-69.1|-59.2||||||TG \<200 mg/dL (Week 12): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region.||-59.2|-69.1|
70993202|NCT01968954|141495177|SUPERIORITY_OR_OTHER||LS mean difference|-59.6|STANDARD_ERROR_OF_MEAN|5.99|||TWO_SIDED|95.0|-71.4|-47.7||||||TG \>=200 mg/dL (Week 12): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region.||-47.7|-71.4|
70993203|NCT01968954|141495178|SUPERIORITY_OR_OTHER||LS mean difference|-63.4|STANDARD_ERROR_OF_MEAN|2.35|||TWO_SIDED|95.0|-68.0|-58.8||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-58.8|-68.0|
70993204|NCT01968954|141495179|SUPERIORITY_OR_OTHER||LS mean difference|-67.1|STANDARD_ERROR_OF_MEAN|2.59|||TWO_SIDED|95.0|-72.2|-62.1||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-62.1|-72.2|
70993205|NCT01968954|141495180|SUPERIORITY_OR_OTHER||LS mean difference|-69.7|STANDARD_ERROR_OF_MEAN|2.57|||TWO_SIDED|95.0|-74.7|-64.6||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-64.6|-74.7|
70993206|NCT01968954|141495181|SUPERIORITY_OR_OTHER||LS mean difference|-47.3|STANDARD_ERROR_OF_MEAN|1.74|||TWO_SIDED|95.0|-50.7|-43.8||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-43.8|-50.7|
70993207|NCT01968954|141495182|SUPERIORITY_OR_OTHER||LS mean difference|-10.6|STANDARD_ERROR_OF_MEAN|1.17|||TWO_SIDED|95.0|-12.9|-8.3||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-8.3|-12.9|
70993208|NCT01968954|141495183|SUPERIORITY_OR_OTHER||LS mean difference|2.4|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|95.0|1.4|3.5||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||3.5|1.4|
70993209|NCT01968954|141495184|SUPERIORITY_OR_OTHER||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|95.0|-1.7|-1.4||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-1.4|-1.7|
70993210|NCT01968954|141495184|SUPERIORITY_OR_OTHER||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-1.7|-1.4||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-1.4|-1.7|
70993211|NCT01968954|141495184|SUPERIORITY_OR_OTHER||LS mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-1.4|-1.0||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-1.0|-1.4|
71099137|NCT02539394|141706965|EQUIVALENCE|Two-sided 95% confidence interval||||||0.234|||||||t-test, 2 sided|||The means 4-6 weeks NDI for the two populations is equal||||0.234
71099138|NCT02539394|141706970|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
70993212|NCT01968954|141495185|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.4|-0.3||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-0.3|-0.4|
70993213|NCT01968954|141495185|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.4|-0.3||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-0.3|-0.4|
70993214|NCT01968954|141495185|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.3|-0.2||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-0.2|-0.3|
70993215|NCT01968954|141495186|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.0|||||TWO_SIDED|95.0|13.86|41.64||||||Week 12||41.64|13.86|
70993216|NCT01968954|141495186|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.8|||||TWO_SIDED|95.0|9.32|23.56||||||Week 24||23.56|9.32|
70993217|NCT01968954|141495186|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.8|||||TWO_SIDED|95.0|6.36|15.24||||||Week 52||15.24|6.36|
70993218|NCT01968954|141495187|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|95.2|||||TWO_SIDED|95.0|52.09|173.91||||||Week 12||173.91|52.09|
70993219|NCT01968954|141495187|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|112.2|||||TWO_SIDED|95.0|55.81|225.52||||||Week 24||225.52|55.81|
70993220|NCT01968954|141495187|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|29.1|||||TWO_SIDED|95.0|17.13|49.49||||||Week 52||49.49|17.13|
70993221|NCT03655717|141495201|SUPERIORITY||Mean Difference (Final Values)|-0.038|STANDARD_ERROR_OF_MEAN|0.113||0.94|TWO_SIDED|95.0|-0.259|0.184||The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates for p-values were obtained via a non-parametric resampling approach randomly shuffling condition and refitting the data 10,000 times.|Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for dronabinol conditions (positive values denote higher HbO levels for post-dronabinol scans).|The mean difference in average HbO levels (converted to z-scores) between the pre and post-dose scans for conditions where a participant was dosed with dronabinol (i.e., a main effect for dronabinol dose), estimated via a linear model with with a subject-varying intercept and covariates for (a) overall differences between pre and post-dose scans and (b) visit order.||0.184|-0.259|0.94
70993222|NCT03655717|141495201|SUPERIORITY||Mean Difference (Final Values)|-0.018|STANDARD_ERROR_OF_MEAN|0.206||0.94|TWO_SIDED|95.0|-0.421|0.386||The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates for p-values were obtained via a non-parametric resampling approach randomly shuffling condition and refitting the data 10,000 times.|Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for ethanol conditions (positive values denote higher HbO levels for post-ethanol scans).|The mean difference in average HbO levels (converted to z-scores) between the pre and post-dose scans for conditions where a participant was dosed with ethanol (i.e., a main effect for ethanol dose), estimated via a linear model with with a subject-varying intercept and covariates for (a) overall differences between pre and post-dose scans and (b) visit order.||0.386|-0.421|0.94
71099139|NCT02205359|141706972|SUPERIORITY||Hazard Ratio (HR)|0.888|STANDARD_ERROR_OF_MEAN|0.067||0.077|TWO_SIDED|95.0|0.779|1.013|||Regression, Cox|Stratified by NYHA class and with investigational site as a random effect|Stratified by NYHA class and with investigational site as a random effect, Standard Error reported on log hazard scale|||1.013|0.779|0.077
71099140|NCT02205359|141706973|SUPERIORITY||Hazard Ratio (HR)|0.881|STANDARD_ERROR_OF_MEAN|0.081||0.12|TWO_SIDED|95.0|0.752|1.032|||Regression, Cox|Stratified by NYHA class and with investigational site as a random effect|Stratified by NYHA class and with investigational site as a random effect, Standard Error reported on log hazard scale|||1.032|0.752|0.12
71099141|NCT02205359|141706974|SUPERIORITY||Hazard Ratio (HR)|0.906|STANDARD_ERROR_OF_MEAN|0.09||0.28|TWO_SIDED|95.0|0.759|1.082|||Regression, Cox|Stratified by NYHA class and with investigational site as a random effect|Stratified by NYHA class and with investigational site as a random effect, Standard Error reported on log hazard scale|||1.082|0.759|0.28
70993223|NCT03655717|141495201|SUPERIORITY||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.281||0.94|TWO_SIDED|95.0|-0.535|0.568||The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates for p-values were obtained via a non-parametric resampling approach randomly shuffling condition and refitting the data 10,000 times.|Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for the dronabinol + ethanol condition (positive values denote higher HbO levels for post-dronabinol+ethanol scans).|The mean difference in average HbO levels (converted to z-scores) between the pre and post-dose scans for conditions where a participant was dosed with both dronabinol and ethanol (i.e., the interaction between dronabinol and ethanol doses), estimated via a linear model with with a subject-varying intercept and covariates for (a) overall differences between pre and post-dose scans and (b) visit order.||0.568|-0.535|0.94
70993224|NCT03655717|141495202|SUPERIORITY||Mean Difference (Final Values)|-0.163|STANDARD_ERROR_OF_MEAN|0.113||0.94|TWO_SIDED|95.0|-0.384|0.057||The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates for p-values were obtained via a non-parametric resampling approach randomly shuffling condition and refitting the data 10,000 times.|Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for dronabinol conditions (positive values denote higher HbO levels for post-dronabinol scans).|The mean difference in average HbO levels (converted to z-scores) between the pre and post-dose scans for conditions where a participant was dosed with dronabinol (i.e., a main effect for dronabinol dose), estimated via a linear model with with a subject-varying intercept and covariates for (a) overall differences between pre and post-dose scans and (b) visit order.||0.057|-0.384|0.94
70993225|NCT03655717|141495202|SUPERIORITY||Mean Difference (Final Values)|-0.176|STANDARD_ERROR_OF_MEAN|0.21||0.94|TWO_SIDED|95.0|-0.588|0.237||The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates for p-values were obtained via a non-parametric resampling approach randomly shuffling condition and refitting the data 10,000 times.|Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for ethanol conditions (positive values denote higher HbO levels for post-ethanol scans).|The mean difference in average HbO levels (converted to z-scores) between the pre and post-dose scans for conditions where a participant was dosed with ethanol (i.e., a main effect for ethanol dose), estimated via a linear model with with a subject-varying intercept and covariates for (a) overall differences between pre and post-dose scans and (b) visit order.||0.237|-0.588|0.94
70993226|NCT03655717|141495202|SUPERIORITY||Mean Difference (Final Values)|0.187|STANDARD_ERROR_OF_MEAN|0.276||0.94|TWO_SIDED|95.0|-0.354|0.728||The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates for p-values were obtained via a non-parametric resampling approach randomly shuffling condition and refitting the data 10,000 times.|Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for the dronabinol + ethanol condition (positive values denote higher HbO levels for post-dronabinol+ethanol scans).|The mean difference in average HbO levels (converted to z-scores) between the pre and post-dose scans for conditions where a participant was dosed with both dronabinol and ethanol (i.e., the interaction between dronabinol and ethanol doses), estimated via a linear model with with a subject-varying intercept and covariates for (a) overall differences between pre and post-dose scans and (b) visit order.||0.728|-0.354|0.94
70993227|NCT01185249|141495203|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis-no difference in morning and evening weights on three consecutive days.|Mean Difference (Final Values)|0.62|STANDARD_DEVIATION|3.09|<|0.001|TWO_SIDED|95.0|-0.51306|1.73806|||t-test, 1 sided|||Analysis of within subjects design morning and evening weights. Null hypothesis is that there is no difference between morning and evening weights.||1.73806|-0.51306|<.001
70993228|NCT01185249|141495203|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 1 sided|||||||0.01
70993229|NCT02300077|141495211|SUPERIORITY|||||||0.0001|||||||Chi-squared|||||||0.0001
70993230|NCT02300077|141495212|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||||||0.01
70993231|NCT02300077|141495213|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
70993232|NCT02300077|141495214|SUPERIORITY|||||||0.02|||||||Kruskal-Wallis|||||||0.02
70993233|NCT03003403|141495222|SUPERIORITY||Risk Ratio (RR)|1.0||||0.97|TWO_SIDED|95.0|0.82|1.2|||bootstrap resampling|||||1.20|0.82|0.97
70993234|NCT03003403|141495223|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.83|TWO_SIDED|95.0|-1.24|1.0|||Mixed Models Analysis|||||1.00|-1.24|0.83
70993235|NCT03003403|141495224|SUPERIORITY|Difference in systolic blood pressure change post-baseline comparing intervention to usual care arm at 24 months.|Mean Difference (Final Values)|-1.2||||0.34|TWO_SIDED|95.0|-3.6|1.3|||Mixed Models Analysis|||||1.3|-3.6|0.34
71039805|NCT01139762|141587535|SUPERIORITY_OR_OTHER||LS Mean Difference|0.62|||<|0.001|TWO_SIDED|95.0|0.35|0.89||P-value is for Question 4 - 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.89|0.35|<0.001
71039806|NCT02614196|141587536|SUPERIORITY||LSMean Difference|-2.02|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.55|-1.48|||Mixed Models Analysis|||||-1.48|-2.55|<.001
71039807|NCT02614196|141587536|SUPERIORITY||LSMean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.44|-1.36|||Mixed Models Analysis|||||-1.36|-2.44|<.001
71039808|NCT02614196|141587537|SUPERIORITY||Odds Ratio (OR)|2.6|||||TWO_SIDED|95.0|2.03|3.32||||||Reduction from Baseline ≥50%||3.32|2.03|
71039809|NCT02614196|141587537|SUPERIORITY||Odds Ratio (OR)|2.31|||||TWO_SIDED|95.0|1.81|2.96||||||Reduction from Baseline ≥50%||2.96|1.81|
71039810|NCT02614196|141587537|SUPERIORITY||Odds Ratio (OR)|2.34|||||TWO_SIDED|95.0|1.78|3.06||||||Reduction from Baseline ≥75%||3.06|1.78|
71039811|NCT02614196|141587537|SUPERIORITY||Odds Ratio (OR)|2.42|||||TWO_SIDED|95.0|1.84|3.17||||||Reduction from Baseline ≥75%||3.17|1.84|
71039812|NCT02614196|141587537|SUPERIORITY||Odds Ratio (OR)|2.16|||||TWO_SIDED|95.0|1.5|3.12||||||Reduction from Baseline ≥100%||3.12|1.50|
70993236|NCT03003403|141495224|SUPERIORITY|Difference in diastolic blood pressure change post-baseline comparing intervention to usual care arm at 24 months.|Mean Difference (Final Values)|-0.8||||0.323|TWO_SIDED|95.0|-2.4|0.8|||Mixed Models Analysis|||||0.8|-2.4|0.323
70993237|NCT03003403|141495225|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.991|TWO_SIDED|95.0|-0.8|0.8|||Mixed Models Analysis|||||0.8|-0.8|0.991
70993238|NCT04124692|141495238|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
70993239|NCT04124692|141495239|SUPERIORITY||||||=|0.0043|||||||Fisher Exact|||||||= 0.0043
70993240|NCT04124692|141495239|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
70993241|NCT02370498|141495260|OTHER||Hazard Ratio (HR)|1.27||||0.98358|TWO_SIDED|95.0|1.03|1.57||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\< 6 months vs. \>= 6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (Hazard Ratio \[HR\]) between the treatment arms.||1.57|1.03|0.98358
70993242|NCT02370498|141495261|OTHER||Hazard Ratio (HR)|0.82||||0.04205|TWO_SIDED|95.0|0.66|1.03||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\< 6 months vs. \>= 6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in OS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.03|0.66|0.04205
70993243|NCT02370498|141495262|OTHER||Hazard Ratio (HR)|1.49||||0.99999|TWO_SIDED|95.0|1.25|1.77||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\< 6 months vs. \>= 6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (Hazard Ratio \[HR\]) between the treatment arms.||1.77|1.25|0.99999
70993244|NCT02370498|141495263|OTHER||Hazard Ratio (HR)|0.94||||0.24463|TWO_SIDED|95.0|0.79|1.12||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\<6 months vs. ≥6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in OS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (Hazard Ratio \[HR\]) between the treatment arms.||1.12|0.79|0.24463
70993245|NCT02370498|141495264|OTHER||Hazard Ratio (HR)|0.98||||0.41331|TWO_SIDED|95.0|0.79|1.21||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\<6 months vs. ≥6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.21|0.79|0.41331
70993246|NCT02370498|141495265|OTHER||Hazard Ratio (HR)|1.19||||0.97481|TWO_SIDED|95.0|1.0|1.42||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\<6 months vs. ≥6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.42|1.00|0.97481
70993247|NCT02370498|141495266|OTHER||Hazard Ratio (HR)|1.11||||0.80696|TWO_SIDED|95.0|0.89|1.38||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\<6 months vs. ≥6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.38|0.89|0.80696
70993248|NCT02370498|141495267|OTHER||Hazard Ratio (HR)|1.34||||0.99932|TWO_SIDED|95.0|1.12|1.6||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\< 6 months vs. \>= 6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.60|1.12|0.99932
70993249|NCT02370498|141495268|OTHER||Hazard Ratio (HR)|1.45||||0.99661|TWO_SIDED|95.0|1.11|1.89||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\<6 months vs. ≥6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in TTP was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.89|1.11|0.99661
71039813|NCT02614196|141587537|SUPERIORITY||Odds Ratio (OR)|2.67|||||TWO_SIDED|95.0|1.87|3.81||||||Reduction from Baseline ≥100%||3.81|1.87|
70993250|NCT02370498|141495269|OTHER||Hazard Ratio (HR)|1.77||||1|TWO_SIDED|95.0|1.42|2.2||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\< 6 months vs. \>= 6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in TTP was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||2.20|1.42|1.00000
70993251|NCT02370498|141495270|OTHER||Hazard Ratio (HR)|0.97||||0.3928|TWO_SIDED|95.0|0.77|1.23||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\<6 months vs. ≥6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in TTP was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.23|0.77|0.39280
70993252|NCT02370498|141495271|OTHER||Hazard Ratio (HR)|1.21||||0.97033|TWO_SIDED|95.0|1.0|1.47||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\< 6 months vs. \>= 6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in TTP was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.47|1.00|0.97033
70993253|NCT02370498|141495272|OTHER||Difference in Percentage|2.0||||0.28967|TWO_SIDED|95.0|-5.0|9.1||Stratification factors for MN method included geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\<6 months vs. ≥6 months) weighting by sample size.|Miettinen and Nurminen method|P-value rounded to 5 decimal places.||Stratified Miettinen and Nurminen's (MN) method was used for comparison of the ORR between the treatment arms. A 95% CI for the difference in response rates between the pembrolizumab arm and paclitaxel arm was provided.||9.1|-5.0|0.28967
70993254|NCT02370498|141495273|OTHER||Difference in Percentage|-1.3||||0.6901|TWO_SIDED|95.0|-6.5|4.0||Stratification factors for MN method included geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\<6 months vs. ≥6 months), and PD-L1 status (positive vs. negative) weighting by sample size|Miettinen and Nurminen method|P-value rounded to 5 decimal places.||Stratified MN method was used for comparison of the ORR between the treatment arms. A 95% CI for the difference in response rates between the pembrolizumab arm and paclitaxel arm was provided.||4.0|-6.5|0.69010
70993255|NCT02370498|141495274|OTHER||Difference in Percentage|1.6||||0.3322|TWO_SIDED|95.0|-5.8|9.1||Stratification factors for MN method included geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\<6 months vs. ≥6 months), weighting by sample size.|Miettinen and Nurminen method|P-value rounded to 5 decimal places.||Stratified MN method was used for comparison of the ORR between the treatment arms. A 95% CI for the difference in response rates between the pembrolizumab arm and paclitaxel arm was provided.||9.1|-5.8|0.33220
70993256|NCT02370498|141495275|OTHER||Difference in Percentage|-3.0||||0.85922|TWO_SIDED|95.0|-8.5|2.6||Stratification factors included geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\<6 months vs. ≥6 months), and PD-L1 status (positive vs. negative) weighting by sample size.|Miettinen and Nurminen method|P-value rounded to 5 decimal places.||Stratified Miettinen and Nurminen's method was used for comparison of the ORR between the treatment arms. A 95% CI for the difference in response rates between the pembrolizumab arm and paclitaxel arm is provided.||2.6|-8.5|0.85922
70993257|NCT02370498|141495281|OTHER||Difference in Percentage|-3.2|||||TWO_SIDED|95.0|-6.9|0.2||||||Between-treatment differences (Pembrolizumab vs. Paclitaxel) in the percentage of participants with events and accompanying 95% confidence intervals were based on the Miettinen and Nurminen method. Negative values correspond to a greater percentage of events for Paclitaxel.||0.2|-6.9|
70993258|NCT01122030|141495285|SUPERIORITY_OR_OTHER|||||||0.0767||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.0767
70993259|NCT01122030|141495285|SUPERIORITY_OR_OTHER|||||||0.8727||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.8727
71039814|NCT02614196|141587538|SUPERIORITY||LSMean Difference|8.82|STANDARD_ERROR_OF_MEAN|1.27|<|0.001|TWO_SIDED|95.0|6.33|11.31|||Mixed Models Analysis|||||11.31|6.33|<.001
70993260|NCT01122030|141495285|SUPERIORITY_OR_OTHER|||||||0.6373||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.6373
71039815|NCT02614196|141587538|SUPERIORITY||LSMean Difference|7.39|STANDARD_ERROR_OF_MEAN|1.28|<|0.001|TWO_SIDED|95.0|4.88|9.9|||Mixed Models Analysis|||||9.90|4.88|<.001
71039816|NCT02614196|141587539|SUPERIORITY||LSMean Difference|-1.82|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.29|-1.36|||Mixed Models Analysis|||||-1.36|-2.29|<.001
71039817|NCT02614196|141587539|SUPERIORITY||LSMean Difference|-1.78|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.25|-1.31|||Mixed Models Analysis|||||-1.31|-2.25|<.001
71039818|NCT02614196|141587540|SUPERIORITY||LSMean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.09||0.002|TWO_SIDED|95.0|-0.47|-0.11|||Mixed Models Analysis|||||-0.11|-0.47|.002
71039819|NCT02614196|141587540|SUPERIORITY||LSMean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.09||0.012|TWO_SIDED|95.0|-0.41|-0.05|||Mixed Models Analysis|||||-0.05|-0.41|.012
71039820|NCT02614196|141587541|SUPERIORITY||LSMean Difference|-15.19|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|-20.27|-10.11|||Mixed Models Analysis|||||-10.11|-20.27|<.001
71039821|NCT02614196|141587541|SUPERIORITY||LSMean Difference|-13.56|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-18.67|-8.44|||Mixed Models Analysis|||||-8.44|-18.67|<.001
71039822|NCT02614196|141587542|SUPERIORITY||LSMean Difference|-9.15|STANDARD_ERROR_OF_MEAN|1.76|<|0.001|TWO_SIDED|95.0|-12.61|-5.69|||Mixed Models Analysis|||||-5.69|-12.61|<.001
71039823|NCT02614196|141587542|SUPERIORITY||LSMean Difference|-8.22|STANDARD_ERROR_OF_MEAN|1.78|<|0.001|TWO_SIDED|95.0|-11.71|-4.72|||Mixed Models Analysis|||||-4.72|-11.71|<.001
70993261|NCT01122030|141495285|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||<0.0001
70993262|NCT01122030|141495285|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||<0.0001
70993263|NCT01122030|141495285|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||<0.0001
70993264|NCT01122030|141495286|SUPERIORITY_OR_OTHER|||||||0.8982||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.8982
70993265|NCT01122030|141495286|SUPERIORITY_OR_OTHER|||||||0.4946||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.4946
70993266|NCT01122030|141495286|SUPERIORITY_OR_OTHER|||||||0.9301||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.9301
70993267|NCT01122030|141495286|SUPERIORITY_OR_OTHER|||||||0.0047||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.0047
70993268|NCT01122030|141495286|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||<0.0001
70993269|NCT01122030|141495286|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||<0.0001
71039824|NCT02614196|141587543|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||TE ADA Positive.||||<.001
71039825|NCT02614196|141587543|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||TE ADA Positive||||<.001
71039826|NCT02627001|141587556|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed Ranks|||||||<0.001
71039827|NCT02005562|141587569|SUPERIORITY_OR_OTHER|||||||0.479|||||||Chi-squared|||||||0.479
71039828|NCT02005562|141587570|SUPERIORITY_OR_OTHER|||||||0.6736|||||||ANOVA|||||||0.6736
70993270|NCT01122030|141495287|SUPERIORITY_OR_OTHER|||||||0.1334||95.0|||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.1334
71039829|NCT02005562|141587571|SUPERIORITY_OR_OTHER|||||||0.2172|||||||ANOVA|||||||0.2172
71039830|NCT02005562|141587572|SUPERIORITY_OR_OTHER|||||||0.477|||||||ANOVA|||||||0.4770
71039831|NCT02005562|141587574|SUPERIORITY_OR_OTHER|||||||0.0764|||||||Log Rank|||||||0.0764
71039832|NCT02005562|141587575|SUPERIORITY_OR_OTHER|||||||0.418|||||||Fisher Exact|||Week 12||||0.418
70993271|NCT01122030|141495287|SUPERIORITY_OR_OTHER|||||||0.332||95.0|||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.3320
70993272|NCT01122030|141495287|SUPERIORITY_OR_OTHER|||||||0.9371||95.0|||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.9371
70993273|NCT01122030|141495287|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.0002
70993274|NCT01122030|141495287|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||<0.0001
70993275|NCT01122030|141495287|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||<0.0001
70993276|NCT01122030|141495288|SUPERIORITY_OR_OTHER|||||||0.7978||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.7978
70993277|NCT01122030|141495288|SUPERIORITY_OR_OTHER|||||||0.7143||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.7143
70993278|NCT01122030|141495288|SUPERIORITY_OR_OTHER|||||||0.7531||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.7531
71039833|NCT02005562|141587575|SUPERIORITY_OR_OTHER|||||||0.841|||||||Fisher Exact|||Week 52||||0.841
71039834|NCT02005562|141587576|SUPERIORITY_OR_OTHER|||||||0.245|||||||Fisher Exact|||Week 12||||0.245
71039835|NCT02005562|141587576|SUPERIORITY_OR_OTHER|||||||0.637|||||||Fisher Exact|||Week 52||||0.637
71039836|NCT02005562|141587577|SUPERIORITY_OR_OTHER|||||||0.512||||||Mycophenolate Mofetil, Adapted Dose vs. Mycophenolate Mofetil, Fixed Dose at protocol biopsy at Week 12.|Fisher Exact|||||||0.512
71039837|NCT02005562|141587577|SUPERIORITY_OR_OTHER|||||||0.718||||||Mycophenolate Mofetil, Adapted Dose vs. Mycophenolate Mofetil, Fixed Dose at protocol biopsy at Week 52.|Fisher Exact|||||||0.718
71039838|NCT02005562|141587579|SUPERIORITY_OR_OTHER|||||||0.86|||||||Log Rank|||||||0.860
71039839|NCT01680016|141587595|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was achieved if the lower limit of the two-sided 95% CI around the observed ratio of GMCs between the groups (GMCGroup Zagreb / GMCGroup Essen) was greater than 0.5|Ratio of GMCs between two groups(Day 15)|0.84|||||TWO_SIDED|95.0|0.69|1.02|||ANOVA|||To demonstrate noninferiority in immune response of the Zagreb post-exposure schedule of Rabipur to that of the conventional Essen post-exposure schedule at day 15 in children aged ≥6 to ≤17 years||1.02|0.69|
71039840|NCT01680016|141587596|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was achieved if the lower limit of the two-sided 95% CI around the observed ratio of GMCs between the groups (GMCGroup Zagreb / GMCGroup Essen) was greater than 0.5|Ratio of GMCs between two groups(Day 15)|1.09|||||TWO_SIDED|95.0|0.87|1.35|||ANOVA|||To demonstrate noninferiority in immune response of the Zagreb post-exposure schedule of Rabipur to that of the conventional Essen post-exposure schedule at day 15 in older adults aged ≥51 years||1.35|0.87|
71039841|NCT00202839|141587626|SUPERIORITY_OR_OTHER|||||||0.1651||95.0|||||Chi-squared|||||||0.1651
71099142|NCT02205359|141706975|SUPERIORITY|Endpoint for statistical analysis is the proportion Improved.|Odds Ratio (OR)|0.888|STANDARD_ERROR_OF_MEAN|0.074||0.11|TWO_SIDED|95.0|0.768|1.026|||Regression, Logistic|Stratified by NYHA class and with investigational site as a random effect|Standard Error is on log-odds ratio scale|||1.026|0.768|0.11
70993279|NCT01122030|141495288|SUPERIORITY_OR_OTHER|||||||0.0283||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.0283
70993280|NCT01122030|141495288|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||<0.0001
70993281|NCT01122030|141495288|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||<0.0001
70993282|NCT01122030|141495289|SUPERIORITY_OR_OTHER|||||||0.6269||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.6269
70993283|NCT01122030|141495289|SUPERIORITY_OR_OTHER|||||||0.7456||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.7456
70993284|NCT01122030|141495289|SUPERIORITY_OR_OTHER|||||||0.1968||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.1968
71099143|NCT02205359|141706976|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.89|TWO_SIDED|95.0|0.85|1.16|||Regression, Cox|Stratified by NYHA class and with investigational site as a random effect||||1.16|0.85|0.89
71099144|NCT02205359|141706977|SUPERIORITY||Difference in mean change from baseline|-0.07||||0.88|TWO_SIDED|95.0|-1.03|0.89|||ANCOVA|Stratified by NYHA class and with investigational site as a random effect||||0.89|-1.03|0.88
70993285|NCT01122030|141495289|SUPERIORITY_OR_OTHER|||||||0.8708||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.8708
70993286|NCT01122030|141495289|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||<0.0001
71099145|NCT02205359|141706978|SUPERIORITY||Difference in mean change from baseline|0.0013||||0.75|TWO_SIDED|95.0|-0.0068|0.0094|||ANCOVA|Stratified by NYHA class and with investigational site as a random effect||||0.0094|-0.0068|0.75
71099146|NCT02205359|141706979|SUPERIORITY||rate ratio|1.15||||0.52|TWO_SIDED|95.0|0.75|1.75|||negative binomial regression|Stratified by NYHA class||||1.75|0.75|0.52
71099147|NCT01793129|141707025|SUPERIORITY|This trial estimated the probability that the intervention has no effect on the outcome (or conversely, the probability that id does), given the data obtained in the trial and any prior evidence.|Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.74|2.0|||||The relative risk estimate was calculated by dividing risk under hypothermia by risk under normothermia.|Whole-body Hypothermia vs. Normothermia (Normothermia is the comparison group)|To get estimates of RR from the Bayesian logistic regression model, predicted probabilities of the outcome were generated for all infants assuming the infants were treated with and without hypothermia and with/without severe encephalopathy. Next subject level RR values were estimated for all infants and 2.5, 50, and 97.5 percentiles were calculated.|2.00|0.74|
71099148|NCT03681093|141707047|SUPERIORITY||Least Squares (LS) Mean|0.05|STANDARD_ERROR_OF_MEAN|0.323||0.979|TWO_SIDED|95.0|-0.59|0.7||Adjusted p-value is reported. The adjusted p-value was obtained from the Dunnet Multiplicity Correction applied to control the Type I error for the primary analysis.|Mixed Model for Repeated Measures (MMRM)|||||0.70|-0.59|0.979
71099149|NCT03681093|141707047|SUPERIORITY||LS Mean|-0.25|STANDARD_ERROR_OF_MEAN|0.319||0.656|TWO_SIDED|95.0|-0.88|0.39||Adjusted p-value is reported. The adjusted p-value was obtained from the Dunnet Multiplicity Correction applied to control the Type I error for the primary analysis.|MMRM|||||0.39|-0.88|0.656
71099150|NCT03681093|141707048|SUPERIORITY||LS Mean|0.64|STANDARD_ERROR_OF_MEAN|0.249||0.012|TWO_SIDED|95.0|0.15|1.14||Unadjusted p-value|MMRM|||||1.14|0.15|0.012
71099151|NCT03681093|141707048|SUPERIORITY||LS Mean|0.45|STANDARD_ERROR_OF_MEAN|0.248||0.074|TWO_SIDED|95.0|-0.04|0.94||Unadjusted p-value|MMRM|||||0.94|-0.04|0.074
71099152|NCT03681093|141707049|SUPERIORITY||LS Mean|5.22|STANDARD_ERROR_OF_MEAN|4.881||0.288|TWO_SIDED|95.0|-4.49|14.93||Unadjusted p-value|MMRM|||||14.93|-4.49|0.288
70993287|NCT01122030|141495289|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.0002
70993288|NCT01122030|141495290|SUPERIORITY_OR_OTHER|||||||0.6131||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.6131
70993289|NCT01122030|141495290|SUPERIORITY_OR_OTHER|||||||0.9293||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.9293
70993290|NCT01122030|141495290|SUPERIORITY_OR_OTHER|||||||0.799||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.7990
70993291|NCT01122030|141495290|SUPERIORITY_OR_OTHER|||||||0.7674||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.7674
70993292|NCT01122030|141495290|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||<0.0001
71099153|NCT03681093|141707049|SUPERIORITY||LS Mean|-2.17|STANDARD_ERROR_OF_MEAN|4.936||0.661|TWO_SIDED|95.0|-11.99|7.65||Unadjusted p-value|MMRM|||||7.65|-11.99|0.661
71099154|NCT03681093|141707050|SUPERIORITY||LS Mean|0.61|STANDARD_ERROR_OF_MEAN|1.809||0.735|TWO_SIDED|95.0|-2.98|4.21||Unadjusted p-value|MMRM|||||4.21|-2.98|0.735
71099155|NCT03681093|141707050|SUPERIORITY||LS Mean|4.51|STANDARD_ERROR_OF_MEAN|1.821||0.015|TWO_SIDED|95.0|0.89|8.13||Unadjusted p-value|MMRM|||||8.13|0.89|0.015
70993293|NCT01122030|141495290|SUPERIORITY_OR_OTHER|||||||0.0018||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.0018
70993294|NCT01122030|141495291|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.7434|TWO_SIDED|95.0|0.42|3.92|||Log Rank|P-values were obtained from the log-rank test stratified by Gender.||||3.92|0.42|0.7434
71039842|NCT01863186|141587629|SUPERIORITY|||||||0.0166|||||||Pattern Mixture Model|||Due to the amount of missing data a pattern mixture model (or Jump to Reference) was utilized. The SOWS-Gossop total scores were log transformed. Each subjects available data Days 1-7 were included. The datasets created by the pattern mixture model were analyzed using a Mixed Model Repeated Measures model that included fixed effects for treatment group, baseline, sex, study day (1-7), and treatment group-by-day interaction. The overall estimate for each treatment group were compared.||||0.0166
71039843|NCT01863186|141587629|SUPERIORITY|||||||0.0033|||||||Pattern Mixture Model|||Due to the amount of missing data a pattern mixture model (or Jump to Reference) was utilized. The SOWS-Gossop total scores were log transformed. Each subjects available data Days 1-7 were included. The datasets created by the pattern mixture model were analyzed using a Mixed Model Repeated Measures model that included fixed effects for treatment group, baseline, sex, study day (1-7), and treatment group-by-day interaction. The overall estimate for each treatment group were compared.||||0.0033
71039844|NCT00377156|141587631|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|-28.2|||<|0.001|TWO_SIDED|90.0|-41.9|-14.4|||Fisher Exact||Cognitive deterioration, the primary end point in evaluable patients at 3 months, was less frequent after Arm I than Arm II (40/63 \[63.5%\] vs 44/48 \[91.7%\],\> respectively. The percent difference was -28.2%; 90% CI, -41.9% to -14.4%; P \< .001).|||-14.4|-41.9|<0.001
71039845|NCT00377156|141587632|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|-18.4|||<|0.001|TWO_SIDED|95.0|-29.0|-7.8|||Fisher Exact|||||-7.8|-29.0|<0.001
71039846|NCT00377156|141587633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.9||||0.001|TWO_SIDED|95.0|4.8|19.0|||t-test, 2 sided|||||19.0|4.8|0.001
71039847|NCT00377156|141587634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-34.4||||0.04|TWO_SIDED|95.0|-74.4|5.5|||Fisher Exact||The incidence of cognitive deterioration was less in Arm I than Arm II at 12 months (6/10 \[60%\] vs 17/18 \[94.4%\]. The percent difference was -34.4% (95% CI: -74.4% to 5.5%; P = .04)|||5.5|-74.4|0.04
71039848|NCT00377156|141587635|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.02||||0.92|TWO_SIDED|95.0|0.75|1.38|||Regression, Cox|||||1.38|0.75|0.92
70993295|NCT01122030|141495291|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.54||||0.4449|TWO_SIDED|95.0|0.54|4.42|||Log Rank|P-values were obtained from the log-rank test stratified by Gender.||||4.42|0.54|0.4449
70993296|NCT01122030|141495291|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.8129|TWO_SIDED|95.0|0.27|2.72|||Log Rank|P-values were obtained from the log-rank test stratified by Gender.||||2.72|0.27|0.8129
71039849|NCT00288704|141587636|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|Comparison of p-value was a parametric ANCOVA main effects model with part A Baseline variable as covariate and treatment.||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<.0001
71039850|NCT00288704|141587637|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Comparison of p-value was a parametric ANCOVA main effects model with part A Baseline variable as covariate and treatment.||"Subjects received rilonacept 160 mg for 9 weeks (weeks 6-15), and then were re-randomized 1:1 into either Placebo or rilonacept 160 mg. The endpoint for the period was 9 weeks later (week 24).~The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used."||||<0.001
71039851|NCT00288704|141587638|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|Comparison of p-value was a parametric ANCOVA main effects model with part A Baseline variable as covariate and treatment.||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<.0001
71039852|NCT00288704|141587639|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|Comparison P-Value was a parametric ANCOVA main effects model with Part A Baseline variable as covariate and treatment.||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<0.0001
71039853|NCT00288704|141587640|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|Comparison p-value is a parametric ANCOVA main effects model with Part A Baseline variable as covariate and treatment.||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<.0001
71039854|NCT00288704|141587641|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|Comparison p-value was a parametric ANCOVA main effects model with Part A Baseline variable as covariate and treatment.||"Please note that the changes are medians (not means).~The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used."||||<0.0001
70993297|NCT01122030|141495291|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|7.52||||0.0005|TWO_SIDED|95.0|2.29|24.72|||Log Rank|P-values were obtained from the log-rank test stratified by Gender.||||24.72|2.29|0.0005
70993298|NCT01122030|141495291|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|9.93|||<|0.0001|TWO_SIDED|95.0|3.09|31.89|||Log Rank|P-values were obtained from the log-rank test stratified by Gender.||||31.89|3.09|<0.0001
70993299|NCT01122030|141495291|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|202272814.0|||<|0.0001||95.0|||||Log Rank|P-values were obtained from the log-rank test stratified by Gender.|Hazard Ratio is infinite due to small range of observed times in 3 mg group that has no overlap with the Placebo group.|||||<0.0001
70993300|NCT01122030|141495292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51||||0.4923|TWO_SIDED|95.0|0.53|4.28|||Log Rank|P-values are from the log rank test stratified by gender.||||4.28|0.53|0.4923
70993301|NCT01122030|141495292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||0.5479|TWO_SIDED|95.0|0.52|4.06|||Log Rank|P-values are from the log rank test stratified by gender.||||4.06|0.52|0.5479
70993302|NCT01122030|141495292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.44||||0.506|TWO_SIDED|95.0|0.56|3.67|||Log Rank|P-values are from the log rank test stratified by gender.||||3.67|0.56|0.5060
70993303|NCT01122030|141495292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|7.36||||0.0005|TWO_SIDED|95.0|2.27|23.9|||Log Rank|P-values are from the log rank test stratified by gender.||||23.90|2.27|0.0005
70993304|NCT01122030|141495292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|9.54|||<|0.0001|TWO_SIDED|95.0|3.0|30.35|||Log Rank|P-values are from the log rank test stratified by gender.||||30.35|3.00|<0.0001
70993305|NCT01122030|141495292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|192233779.0|||<|0.0001||95.0|||||Log Rank|P-values are from the log rank test stratified by gender.|Hazard Ratio is infinite due to small range of observed times in 3 mg group that has no overlap with the Placebo group.|||||<0.0001
70993306|NCT01122030|141495293|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.45||||0.1523|TWO_SIDED|95.0|0.62|19.35|||Log Rank|P-values are from the log rank test stratified by gender.||||19.35|0.62|0.1523
71039855|NCT00288704|141587642|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|Comparison p-value was a parametric ANCOVA main effects model with Part A Baseline variable as covariate and treatment.||"Please note that the changes are medians (not means).~The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used."||||<0.01
71039856|NCT00288704|141587643|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<0.0001
71039857|NCT00288704|141587644|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<0.0001
70993307|NCT01122030|141495293|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.55||||0.0856|TWO_SIDED|95.0|0.76|27.07|||Log Rank|P-values are from the log rank test stratified by gender.||||27.07|0.76|0.0856
70993308|NCT01122030|141495293|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.81||||0.5284|TWO_SIDED|95.0|0.3|10.98|||Log Rank|P-values are from the log rank test stratified by gender.||||10.98|0.30|0.5284
70993309|NCT01122030|141495293|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.8594|TWO_SIDED|95.0|0.09|8.66|||Log Rank|P-values are from the log rank test stratified by gender.||||8.66|0.09|0.8594
70993310|NCT01122030|141495293|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|59.34|||<|0.0001|TWO_SIDED|95.0|6.55|537.38|||Log Rank|P-values are from the log rank test stratified by gender.||||537.38|6.55|<0.0001
70993311|NCT01122030|141495293|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|10.99||||0.0007|TWO_SIDED|95.0|2.3|52.57|||Log Rank|P-values are from the log rank test stratified by gender.||||52.57|2.30|0.0007
70993312|NCT01122030|141495295|SUPERIORITY_OR_OTHER|||||||0.5054||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.5054
71039858|NCT00288704|141587645|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<0.0001
71039859|NCT01579006|141587666|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
71039860|NCT01579006|141587667|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
71039861|NCT01579006|141587668|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
70993313|NCT01122030|141495295|SUPERIORITY_OR_OTHER|||||||0.9688||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.9688
70993314|NCT01122030|141495295|SUPERIORITY_OR_OTHER|||||||0.6963||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.6963
70993315|NCT01122030|141495295|SUPERIORITY_OR_OTHER|||||||0.9599||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.9599
70993316|NCT01122030|141495295|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.0001
70993317|NCT01122030|141495295|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.0006
70993318|NCT01122030|141495296|SUPERIORITY_OR_OTHER|||||||0.3441||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.3441
70993319|NCT01122030|141495296|SUPERIORITY_OR_OTHER|||||||0.7159||95.0||||P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.|ANCOVA|||||||0.7159
70993320|NCT01122030|141495296|SUPERIORITY_OR_OTHER|||||||0.7342||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.7342
70993321|NCT01122030|141495296|SUPERIORITY_OR_OTHER|||||||0.8714||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.8714
70993322|NCT01122030|141495296|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||<0.0001
71039862|NCT01579006|141587670|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
71039863|NCT01579006|141587671|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
71039864|NCT01579006|141587677|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
70993323|NCT01122030|141495296|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.0006
70993324|NCT01486784|141495365|OTHER||||||||||||||||||Based on the dose limiting toxicities occurring in each dosing cohort, a maximum tolerated dose (MTD) may be determined by assessing the highest dosing level presenting no dose limiting toxicities. An MTD of 17mg/m2 twice weekly was established.|||
70993325|NCT03491553|141495366|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
70993326|NCT03491553|141495366|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
70993327|NCT03491553|141495366|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
70993328|NCT03491553|141495366|OTHER||Percentage Difference|10.0|||||TWO_SIDED|95.0|-47.2|47.1|||||The 2-sided 95% CI for the percentage difference by HBeAg status was constructed based on the standardized statistic and inverting two 1-sided tests.|||47.1|-47.2|
70993329|NCT03491553|141495367|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
70993330|NCT03491553|141495367|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
70993331|NCT03491553|141495367|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
70993332|NCT03491553|141495367|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
70993333|NCT03491553|141495368|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
70993334|NCT03491553|141495368|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
70993335|NCT03491553|141495368|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
70993336|NCT03491553|141495368|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
70993337|NCT03491553|141495369|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
70993338|NCT03491553|141495369|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
70993339|NCT03491553|141495369|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
71039865|NCT01579006|141587678|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
71039866|NCT01579006|141587679|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
71039867|NCT01579006|141587680|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
71039868|NCT01579006|141587681|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
70993340|NCT03491553|141495369|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
70993341|NCT03491553|141495370|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
70993342|NCT03491553|141495370|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
70993343|NCT03491553|141495370|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
70993344|NCT03491553|141495370|OTHER||Percentage Difference|10.0|||||TWO_SIDED|95.0|-47.2|47.1|||||The 2-sided 95% CI for the percentage difference by HBeAg status was constructed based on the standardized statistic and inverting two 1-sided tests.|||47.1|-47.2|
70993345|NCT00973921|141495386|SUPERIORITY_OR_OTHER||Proportion|1.0|||<|0.01|TWO_SIDED|95.0|0.86|1.0|||Wilson|||The 95% confidence Interval (CI) of the primary outcome has been calculated using the Wilson method of estimating the CI of a single proportion||1.0|0.86|<0.01
70993346|NCT00973921|141495387|SUPERIORITY_OR_OTHER||Correlation coefficient|0.74|||<|0.0001|||||||Bland Altman|||||||<0.0001
70993347|NCT00973921|141495389|SUPERIORITY_OR_OTHER||Correlation coefficient|0.5||||0.0034|||||||Bland-Altman|||||||0.0034
70993348|NCT04593940|141495392|SUPERIORITY||Recovery Rate Ratio|1.122||||0.0793|TWO_SIDED|95.0|0.987|1.275|||Fine-Gray Proportional Hazards Model|||||1.275|0.987|0.0793
70993349|NCT04593940|141495392|SUPERIORITY||Recovery Rate Ratio|1.12||||0.0864|TWO_SIDED|95.0|0.984|1.275|||Fine-Gray Proportional Hazards Model|||||1.275|.984|0.0864
70993350|NCT04593940|141495392|SUPERIORITY||Recovery Rate Ratio|1.006||||0.9354|TWO_SIDED|95.0|0.862|1.176|||Fine-Gray Proportional Hazards Model|||||1.176|0.862|0.9354
70993351|NCT04593940|141495393|SUPERIORITY||Odds Ratio (OR)|1.309||||0.0213|TWO_SIDED|95.0|1.041|1.647|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.647|1.041|0.0213
70993352|NCT04593940|141495393|SUPERIORITY||Odds Ratio (OR)|1.174||||0.1732|TWO_SIDED|95.0|0.932|1.48|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.480|0.932|0.1732
70993353|NCT04593940|141495393|SUPERIORITY||Odds Ratio (OR)|0.944||||0.6823|TWO_SIDED|95.0|0.717|1.243|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.243|0.717|0.6823
70993354|NCT04593940|141495394|SUPERIORITY||Odds Ratio (OR)|0.614||||0.0229|TWO_SIDED|95.0|0.403|0.935|||Regression, Logistic|||||0.935|0.403|0.0229
70993355|NCT04593940|141495394|SUPERIORITY||Odds Ratio (OR)|0.629||||0.0281|TWO_SIDED|95.0|0.416|0.951|||Regression, Logistic|||||0.951|0.416|0.0281
70993356|NCT04593940|141495394|SUPERIORITY||Odds Ratio (OR)|1.167||||0.541|TWO_SIDED|95.0|0.711|1.917|||Regression, Logistic|||||1.917|0.711|0.541
70993357|NCT04593940|141495395|SUPERIORITY||Odds Ratio (OR)|1.435||||0.0032|TWO_SIDED|95.0|1.129|1.825|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.825|1.129|0.0032
70993358|NCT04593940|141495395|SUPERIORITY||Odds Ratio (OR)|1.338||||0.0228|TWO_SIDED|95.0|1.041|1.718|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.718|1.041|0.0228
70993359|NCT04593940|141495395|SUPERIORITY||Odds Ratio (OR)|0.904||||0.4994|TWO_SIDED|95.0|0.675|1.211|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.211|0.675|0.4994
70993360|NCT04593940|141495396|SUPERIORITY||Odds Ratio (OR)|0.632||||0.0988|TWO_SIDED|95.0|0.367|1.09|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.090|0.367|0.0988
71039869|NCT01579006|141587683|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
71039870|NCT02697617|141587696|SUPERIORITY|||||||0.024||||||First analyzed using a Linear Mixed Model to assess if there were carryover effects and then subsequently analyzed using paired t-tests to compare the mean differences between treatments.|Paired t-test|||||||0.024
71039871|NCT02697617|141587697|SUPERIORITY|||||||0.14||||||First analyzed using a Linear Mixed Model to assess if there were carryover effects and then subsequently analyzed using paired t-tests to compare the mean differences between treatments.|Paired t-test|||||||0.14
71039872|NCT02697617|141587699|OTHER||||||||||||||||||comparison by paired t-test|||
70993361|NCT04593940|141495396|SUPERIORITY||Odds Ratio (OR)|0.552||||0.0354|TWO_SIDED|95.0|0.317|0.96|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||0.960|0.317|0.0354
70993362|NCT04593940|141495396|SUPERIORITY||Odds Ratio (OR)|1.287||||0.4132|TWO_SIDED|95.0|0.703|2.355|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||2.355|0.703|0.4132
70993363|NCT04593940|141495397|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.1601|TWO_SIDED|95.0|1.0|1.28|||Fine-Gray Proportional Hazards Model|||||1.28|1.00|0.1601
70993364|NCT04593940|141495397|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.355|TWO_SIDED|95.0|0.97|1.24|||Fine-Gray Proportional Hazards Model|||||1.24|0.97|0.3550
70993365|NCT04593940|141495397|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.2386|TWO_SIDED|95.0|0.8|1.07|||Fine-Gray Proportional Hazards Model|||||1.07|0.80|0.2386
70993366|NCT04593940|141495398|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.1519|TWO_SIDED|95.0|0.98|1.26|||Fine-Gray Proportional Hazards Model|||||1.26|0.98|0.1519
70993367|NCT04593940|141495398|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.2605|TWO_SIDED|95.0|0.98|1.26|||Fine-Gray Proportional Hazards Model|||||1.26|0.98|0.2605
71039873|NCT02697617|141587700|SUPERIORITY|||||||0.15||||||First analyzed using a Linear Mixed Model to assess if there were carryover effects and then subsequently analyzed using paired t-tests to compare the mean differences between treatments.|Paired t-test|||||||0.15
70993368|NCT04593940|141495398|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.4359|TWO_SIDED|95.0|0.83|1.13|||Fine-Gray Proportional Hazards Model|||||1.13|0.83|0.4359
70993369|NCT04593940|141495399|SUPERIORITY||Mean Difference (Net)|-0.06||||0.321|TWO_SIDED|95.0|-0.18|0.06|||t-test, 2 sided|||||0.06|-0.18|0.3210
70993370|NCT04593940|141495399|SUPERIORITY||Mean Difference (Net)|0.04||||0.5275|TWO_SIDED|95.0|-0.09|0.17|||t-test, 2 sided|||||0.17|-0.09|0.5275
71039874|NCT02697617|141587701|SUPERIORITY|||||||0.4||||||First analyzed using a Linear Mixed Model to assess if there were carryover effects and then subsequently analyzed using paired t-tests to compare the mean differences between treatments.|paired t test|||||||0.4
70993371|NCT04593940|141495399|SUPERIORITY||Mean Difference (Net)|0.0||||0.9993|TWO_SIDED|95.0|-0.15|0.15|||t-test, 2 sided|||||0.15|-0.15|0.9993
70993372|NCT04593940|141495400|SUPERIORITY||Mean Difference (Net)|0.07||||0.4982|TWO_SIDED|95.0|-0.13|0.26|||t-test, 2 sided|||||0.26|-0.13|0.4982
70993373|NCT04593940|141495400|SUPERIORITY||Mean Difference (Net)|0.09||||0.3491|TWO_SIDED|95.0|-0.1|0.29|||t-test, 2 sided|||||0.29|-0.10|0.3491
70993374|NCT04593940|141495400|SUPERIORITY||Mean Difference (Net)|-0.01||||0.902|TWO_SIDED|95.0|-0.25|0.22|||t-test, 2 sided|||||0.22|-0.25|0.9020
70993375|NCT04593940|141495401|SUPERIORITY||Mean Difference (Net)|0.24||||0.0842|TWO_SIDED|95.0|-0.03|0.52|||t-test, 2 sided|||||0.52|-0.03|0.0842
70993376|NCT04593940|141495401|SUPERIORITY||Mean Difference (Net)|0.09||||0.5328|TWO_SIDED|95.0|-0.19|0.37|||t-test, 2 sided|||||0.37|-0.19|0.5328
71099156|NCT05033561|141707053|NON_INFERIORITY|Non-inferiority would be verified if the lower bound of the two-sided 95% CI around each difference (shorter interval minus standard interval) is greater than -10%.||||||0.05||||||This is the nominal alpha level for the two-sided confidence interval comparison.|Miettinen-Nurminen|Pairwise comparisons with two-sided Miettinen-Nurminen confidence intervals.||This study was designed to demonstrate the non-inferiority of Group A (1-week interval nOPV2 administration) and Group B (2-weeks interval nOPV2 administration) versus Group C (standard 4-week interval).||||0.05
70993377|NCT04593940|141495401|SUPERIORITY||Mean Difference (Net)|-0.12||||0.4727|TWO_SIDED|95.0|-0.46|0.21|||t-test, 2 sided|||||0.21|-0.46|0.4727
70993378|NCT04593940|141495402|SUPERIORITY||Mean Difference (Net)|0.31||||0.0399|TWO_SIDED|95.0|0.01|0.61|||t-test, 2 sided|||||0.61|0.01|0.0399
70993379|NCT04593940|141495402|SUPERIORITY||Mean Difference (Net)|0.11||||0.4515|TWO_SIDED|95.0|-0.18|0.41|||t-test, 2 sided|||||0.41|-0.18|0.4515
70993380|NCT04593940|141495402|SUPERIORITY||Mean Difference (Net)|-0.07||||0.696|TWO_SIDED|95.0|-0.43|0.29|||t-test, 2 sided|||||0.29|-0.43|0.6960
70993381|NCT04593940|141495403|SUPERIORITY||Mean Difference (Net)|0.26||||0.0903|TWO_SIDED|95.0|-0.04|0.57|||t-test, 2 sided|||||0.57|-0.04|0.0903
70993382|NCT04593940|141495403|SUPERIORITY||Mean Difference (Net)|0.15||||0.348|TWO_SIDED|95.0|-0.16|0.45|||t-test, 2 sided|||||0.45|-0.16|0.3480
70993383|NCT04593940|141495403|SUPERIORITY||Mean Difference (Net)|-0.07||||0.6984|TWO_SIDED|95.0|-0.44|0.29|||t-test, 2 sided|||||0.29|-0.44|0.6984
70993384|NCT04593940|141495404|SUPERIORITY||Mean Difference (Net)|0.32||||0.045|TWO_SIDED|95.0|0.01|0.62|||t-test, 2 sided|||||0.62|0.01|0.0450
70993385|NCT04593940|141495404|SUPERIORITY||Mean Difference (Net)|0.19||||0.2462|TWO_SIDED|95.0|-0.13|0.5|||t-test, 2 sided|||||0.50|-0.13|0.2462
70993386|NCT04593940|141495404|SUPERIORITY||Mean Difference (Net)|-0.23||||0.2304|TWO_SIDED|95.0|-0.61|0.15|||t-test, 2 sided|||||0.15|-0.61|0.2304
70993387|NCT04593940|141495405|SUPERIORITY||Mean Difference (Net)|0.35||||0.0313|TWO_SIDED|95.0|0.03|0.66|||t-test, 2 sided|||||0.66|0.03|0.0313
70993388|NCT04593940|141495405|SUPERIORITY||Mean Difference (Net)|0.31||||0.0555|TWO_SIDED|95.0|-0.01|0.63|||t-test, 2 sided|||||0.63|-0.01|0.0555
70993389|NCT04593940|141495405|SUPERIORITY||Mean Difference (Net)|-0.22||||0.271|TWO_SIDED|95.0|-0.6|0.17|||t-test, 2 sided|||||0.17|-0.60|0.2710
70993390|NCT04593940|141495406|SUPERIORITY||Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|0.0|2.0||||||||2.0|-0.0|
70993391|NCT04593940|141495406|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|95.0|-0.5|1.6||||||||1.6|-0.5|
70993392|NCT04593940|141495406|SUPERIORITY||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-1.8|0.7||||||||0.7|-1.8|
70993393|NCT04593940|141495407|SUPERIORITY||Difference in percentages|29.2|||||TWO_SIDED|95.0|-0.4|53.7||||||||53.7|-0.4|
70993394|NCT04593940|141495407|SUPERIORITY||Difference in percentages|14.0|||||TWO_SIDED|95.0|-14.8|40.0||||||||40.0|-14.8|
70993395|NCT04593940|141495407|SUPERIORITY||Difference in percentages|-5.8|||||TWO_SIDED|95.0|-38.7|26.6||||||||26.6|-38.7|
70993396|NCT04593940|141495408|SUPERIORITY||Mean Difference (Net)|1.2|||||TWO_SIDED|95.0|0.2|2.3||||||||2.3|0.2|
70993397|NCT04593940|141495408|SUPERIORITY||Mean Difference (Net)|0.9|||||TWO_SIDED|95.0|-0.1|2.0||||||||2.0|-0.1|
70993398|NCT04593940|141495408|SUPERIORITY||Mean Difference (Net)|-0.7|||||TWO_SIDED|95.0|-2.0|0.6||||||||0.6|-2.0|
70993399|NCT04593940|141495409|SUPERIORITY||Difference in percentages|-7.0|||||TWO_SIDED|95.0|-14.0|0.0||||||||0.0|-14.0|
70993400|NCT04593940|141495409|SUPERIORITY||Difference in percentages|-3.9|||||TWO_SIDED|95.0|-11.1|3.4||||||||3.4|-11.1|
70993401|NCT04593940|141495409|SUPERIORITY||Difference in percentages|-1.0|||||TWO_SIDED|95.0|-10.1|8.1||||||||8.1|-10.1|
70993402|NCT04593940|141495410|SUPERIORITY||Mean Difference (Net)|0.9|||||TWO_SIDED|95.0|-0.1|1.8||||||||1.8|-0.1|
70993403|NCT04593940|141495410|SUPERIORITY||Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|-0.3|1.7||||||||1.7|-0.3|
71099157|NCT05033561|141707053|NON_INFERIORITY|Non-inferiority would be verified if the lower bound of the two-sided 95% CI around each difference (shorter interval minus standard interval) is greater than -10%.||||||0.05||||||This is the nominal alpha level for the two-sided confidence interval comparison.|Miettinen-Nurminen|Pairwise comparisons with two-sided Miettinen-Nurminen confidence intervals.||This study was designed to demonstrate the non-inferiority of Group A (1-week interval nOPV2 administration) and Group B (2-weeks interval nOPV2 administration) versus Group C (standard 4-week interval).||||0.05
70993404|NCT04593940|141495410|SUPERIORITY||Mean Difference (Net)|-0.8|||||TWO_SIDED|95.0|-2.0|0.4||||||||0.4|-2.0|
70993405|NCT04593940|141495411|SUPERIORITY||Difference in percentages|-1.1|||||TWO_SIDED|95.0|-5.7|3.5||||||||3.5|-5.7|
70993406|NCT04593940|141495411|SUPERIORITY||Difference in percentages|-1.3|||||TWO_SIDED|95.0|-6.0|3.3||||||||3.3|-6.0|
70993407|NCT04593940|141495411|SUPERIORITY||Difference in percentages|2.2|||||TWO_SIDED|95.0|-3.7|8.0||||||||8.0|-3.7|
70993408|NCT04593940|141495412|SUPERIORITY||Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|0.0|2.0||||||||2.0|-0.0|
70993409|NCT04593940|141495412|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-0.7|1.4||||||||1.4|-0.7|
70993410|NCT04593940|141495412|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-1.3|1.1||||||||1.1|-1.3|
70993411|NCT04593940|141495413|SUPERIORITY||Hazard Ratio (HR)|0.878||||0.3169|TWO_SIDED|95.0|0.68|1.133|||Log Rank|||||1.133|0.680|0.3169
70993412|NCT04593940|141495413|SUPERIORITY||Hazard Ratio (HR)|0.863||||0.248|TWO_SIDED|95.0|0.672|1.108|||Log Rank|||||1.108|0.672|0.2480
70993413|NCT04593940|141495413|SUPERIORITY||Hazard Ratio (HR)|1.191||||0.249|TWO_SIDED|95.0|0.885|1.604|||Log Rank|||||1.604|0.885|0.2490
70993414|NCT04593940|141495414|SUPERIORITY||Hazard Ratio (HR)|1.083||||0.5175|TWO_SIDED|95.0|0.85|1.38|||Log Rank|||||1.380|0.850|0.5175
70993415|NCT04593940|141495414|SUPERIORITY||Hazard Ratio (HR)|0.923||||0.5216|TWO_SIDED|95.0|0.722|1.179|||Log Rank|||||1.179|0.722|0.5216
70993416|NCT04593940|141495414|SUPERIORITY||Hazard Ratio (HR)|1.075||||0.6135|TWO_SIDED|95.0|0.812|1.424|||Log Rank|||||1.424|0.812|0.6135
70993417|NCT04593940|141495415|SUPERIORITY||Hazard Ratio (HR)|0.565||||0.3628|TWO_SIDED|95.0|0.165|1.931|||Log Rank|||||1.931|0.165|0.3628
70993418|NCT04593940|141495415|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.3701|TWO_SIDED|95.0|0.167|1.948|||Log Rank|||||1.948|0.167|0.3701
70993419|NCT04593940|141495415|SUPERIORITY||Hazard Ratio (HR)|4.988||||0.0001|TWO_SIDED|95.0|2.211|11.251|||Log Rank|||||11.251|2.211|0.0001
70993420|NCT03970395|141495441|SUPERIORITY||Risk Ratio (RR)|7.66||||0.01|TWO_SIDED|95.0|2.46|23.84||The threshold for statistical significance was p\<0.5|Risk Ratio (RR)||Risk Difference 0.41 (IC 95; 0.25-0.53)|||23.84|2.46|0.01
70993421|NCT03970395|141495442|SUPERIORITY||Risk Ratio (RR)|5.6||||0.01|TWO_SIDED|95.0|2.36|13.27|||Relative Risk (RR)||Risk Difference 0.47 (IC 95; 0.31-0.64)|||13.27|2.36|0.01
70993422|NCT03970395|141495443|SUPERIORITY||Risk Ratio (RR)|7.49||||0.01|TWO_SIDED|95.0|2.42|23.18|||Risk Ratio (RR)||Risk Difference 0.44 (IC 95%; 0.27-0.60)|||23.18|2.42|0.01
70993423|NCT03970395|141495444|SUPERIORITY||Risk Ratio (RR)|4.91||||0.01|TWO_SIDED|95.0|2.12|11.38|||Risk Ratio (RR)||Risk Difference 0.54 (IC 95; 0.36-0.72)|||11.38|2.12|0.01
71039875|NCT02733627|141587756|OTHER||Slope|3.8266|STANDARD_ERROR_OF_MEAN|0.2967|||TWO_SIDED|95.0|3.2155|4.4376||||||The basic model for the investigation of dose proportionality was a power model. The model consisted of a regression model applied to log-transformed data. The corresponding ANCOVA model included the logarithm of the dose as a covariate. The assumption of a linear relationship between the log-transformed pharmacokinetic endpoint and the log-transformed dose was checked.|Standard Error of the mean is actually Standard Error of the slope. Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|4.4376|3.2155|
71039876|NCT02733627|141587757|OTHER||Slope|4.181|STANDARD_ERROR_OF_MEAN|0.3247|||TWO_SIDED|95.0|3.5094|4.8527||||||The basic model for the investigation of dose proportionality was a power model. The model consisted of a regression model applied to log-transformed data. The corresponding ANCOVA model included the logarithm of the dose as a covariate. The assumption of a linear relationship between the log-transformed pharmacokinetic endpoint and the log-transformed dose was checked.|Standard Error of the mean is actually Standard Error of the slope. Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|4.8527|3.5094|
71039877|NCT02733627|141587758|OTHER||Slope|1.8868|STANDARD_ERROR_OF_MEAN|0.3069|||TWO_SIDED|95.0|1.2503|2.5234||||||The basic model for the investigation of dose proportionality was a power model. The model consisted of a regression model applied to log-transformed data. The corresponding ANCOVA model included the logarithm of the dose as a covariate. The assumption of a linear relationship between the log-transformed pharmacokinetic endpoint and the log-transformed dose was checked.|Standard Error of the mean is actually Standard Error of the slope. Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|2.5234|1.2503|
71039878|NCT02733627|141587759|OTHER||Slope|3.0677|STANDARD_ERROR_OF_MEAN|0.4844|||TWO_SIDED|95.0|2.0631|4.0723||||||The basic model for the investigation of dose proportionality was a power model. The model consisted of a regression model applied to log-transformed data. The corresponding ANCOVA model included the logarithm of the dose as a covariate. The assumption of a linear relationship between the log-transformed pharmacokinetic endpoint and the log-transformed dose was checked.|Standard Error of the mean is actually Standard Error of the slope. Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|4.0723|2.0631|
71039879|NCT00183196|141587760|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.529|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|0.281|0.997|||Regression, Cox|||||.997|.281|
71039880|NCT00183196|141587760|SUPERIORITY|||||||0.04|||||||Regression, Cox|percent heavy drinking days at baseline was used as a covariate in the analysis as it was a predictor of overall survival independent of group.||||||0.04
71039881|NCT01721772|141587806|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.3|0.6|||Stratified Log Rank Test|||||0.60|0.30|<0.0001
70993424|NCT00929734|141495457|SUPERIORITY_OR_OTHER|||||||0.292|TWO_SIDED||||||ANCOVA|||||||0.292
70993425|NCT00929734|141495458|SUPERIORITY_OR_OTHER|||||||0.462|TWO_SIDED||||||ANCOVA|||||||0.462
70993426|NCT00929734|141495459|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|||||ANCOVA with natural logarithm of hs-CRP (ln hs-CRP)|ANCOVA|||||||0.017
70993427|NCT00929734|141495460|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED|||||ANCOVA with natural logarithm of interleukin 6 (ln IL6)|ANCOVA|||||||0.028
70993428|NCT00980980|141495461|SUPERIORITY_OR_OTHER|||||||0.01|||||||Proportional-hazards models|Proportional-hazards models with shared frailties accounted for clustering within hospitals.||||||0.01
70993429|NCT00414960|141495470|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|4.04||0.556|TWO_SIDED|95.0|-10.64|5.83||P-value is for comparison of change from baseline between enzastaurin and placebo group.|2-sample pooled t-test||Using placebo as a reference group, the mean difference = enzastaurin minus placebo.|||5.83|-10.64|0.556
70993430|NCT04633473|141495495|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.922|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.922
70993431|NCT04633473|141495496|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.521|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.521
70993432|NCT04633473|141495497|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.678|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.678
70993433|NCT04633473|141495498|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.326|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.326
70993434|NCT04633473|141495499|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.09|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.09
70993435|NCT04633473|141495500|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.154|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.154
71039882|NCT01721772|141587807|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.34|0.56|||Stratified Log Rank Test|||||0.56|0.34|<0.0001
70993436|NCT04633473|141495501|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.309|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.309
70993437|NCT04633473|141495503|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.181|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.181
70993438|NCT04633473|141495504|SUPERIORITY||Mean Difference (Final Values)|0.91||||0.008|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.008
70993439|NCT05291949|141495507|OTHER|Bland-Altman|Bias|0.3|||||TWO_SIDED||||||Bland-Altman||||Lower 95% Limit of agreement (LoA) value = -0.34 Upper 95% LoA = 0.94|||
70993440|NCT00242385|141495536|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To establish bioequivalence in AUC 0-35d divided by the dose administered with a type I error of 5% the calculated two-sided 90% confidence interval were to be contained completely in the margins of equivalence defined as 80% to 125%.|Ratio of Geometric Means|0.928|||||TWO_SIDED|90.0|0.858|1.002||||||||1.002|0.858|
70993441|NCT00242385|141495537|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To establish bioequivalence in AUC 0-infinity divided by the dose administered with a type I error of 5% the calculated two-sided 90% confidence interval were to be contained completely in the margins of equivalence defined as 80% to 125%.|Ratio of Geometric Means|0.934|||||TWO_SIDED|90.0|0.855|1.021||||||||1.021|0.855|
70993442|NCT04348591|141495548|SUPERIORITY||Mean Difference (Final Values)|-0.046|STANDARD_ERROR_OF_MEAN|0.037||0.221|TWO_SIDED|95.0|-0.12|0.029||This p value corresponds to the main effect for experimental group; a-priori threshold was .012|Mixed Models Analysis|||A MMANOVA analysis using an unstructured covariance structure examined main effects of experimental group, instruction provided, headache, racial background, and type of neurostimulation administered. HF-HRV was transformed using an lg function for normality.||.029|-.12|.221
70993443|NCT04348591|141495548|SUPERIORITY|This is a within subject analysis that uses data across groups, controlling for the effect of neurostimulation alone, coil to cortex distance, and racial background|Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.022||0.008|TWO_SIDED|95.0|0.016|0.103|||Mixed Models Analysis|Comparison between sham neurostimulation and high frequency neurostimulation||A MMANOVA analysis using an unstructured covariance examined the main effect of type of neurostimulation provided||.103|.016|.008
71039883|NCT01721772|141587809|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.43|||<|0.0001|TWO_SIDED|95.0|2.75|7.13|||Cochran-Mantel-Haenszel|||||7.13|2.75|<0.0001
71039884|NCT01721772|141587810|SUPERIORITY_OR_OTHER_LEGACY||Unstratified Hazard Ratio|0.37|||||TWO_SIDED|95.0|0.24|0.56|||||PD-L1 positive group|||0.56|0.24|
71039885|NCT01721772|141587810|SUPERIORITY_OR_OTHER_LEGACY||Unstratified Hazard Ratio|0.6|||||TWO_SIDED|95.0|0.45|0.8|||||PD-L1 negative group|||0.80|0.45|
71039886|NCT01721772|141587813|SUPERIORITY||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.41|0.65||||||||0.65|0.41|
71039887|NCT05004649|141587822|OTHER|||||||0.024356||||||When Bonferroni corrected for multiple comparisons the significance level across conditions is p \< 0.0167. This is the Bonferonni corrected level for three tests applied to a baseline significance value of 0.05.|t-test, 2 sided|||||||.024356
71039888|NCT05004649|141587822|OTHER|||||||0.040382||||||When Bonferroni corrected for multiple comparisons the significance level across conditions is p \< 0.0167. This is the Bonferonni corrected level for three tests applied to a baseline significance value of 0.05.|t-test, 2 sided|||||||.040382
71039889|NCT05004649|141587822|OTHER|||||||0.90161||||||When Bonferroni corrected for multiple comparisons the significance level across conditions is p \< 0.0167. This is the Bonferonni corrected level for three tests applied to a baseline significance value of 0.05.|t-test, 2 sided|||||||.90161
71039890|NCT02654145|141587828|SUPERIORITY||Mean Difference (Final Values)|-0.9|||<|0.001|TWO_SIDED|95.0|-1.13|-0.66||p-value is for Difference (Mepo-Placebo) calculated based on the Historical Placebo estimate of -0.55 (Standard Error: 0.05), which was estimated from a meta-analysis of studies NCT01000506 and NCT01691521 using all Placebo participants.|Mixed Model Repeated Measures||Difference (Mepo-Placebo) calculated based on the Historical Placebo estimate of -0.55 (Standard Error: 0.05), which was estimated from a meta-analysis of studies NCT01000506 and NCT01691521 using all Placebo participants.|||-0.66|-1.13|<0.001
70993444|NCT04348591|141495548|SUPERIORITY|The analysis controls for coil to cortex distance, racial background and effect of neurostimulation alone. It compares sham stimulation with low frequency neurostimulation|Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.021||0.001|TWO_SIDED|95.0|0.029|0.111|||Mixed Models Analysis|||A MMANOVA analysis using an unstructured covariance structure examined the main effect of type of neurostimulation provided.||.111|.029|.001
70993445|NCT04348591|141495549|SUPERIORITY||Mean Difference (Final Values)|0.223|STANDARD_ERROR_OF_MEAN|0.232||0.34|TWO_SIDED|95.0|-0.243|0.689|||Mixed Models Analysis||This is the result for the main effect found of group (emotion dysregulation group versus misophonia)|A MMANOVA analysis using an unstructured covariance structure examined changes in SCL between groups, experimental types of neurostimulation, and their interaction, controlling for baseline, racial background, coil to cortex distance, and headache||.689|-.243|.34
70993446|NCT04348591|141495549|SUPERIORITY||Mean Difference (Final Values)|0.493|STANDARD_ERROR_OF_MEAN|0.148||0.001|TWO_SIDED|95.0|0.198|0.787|||Mixed Models Analysis|This is the main effect of neurostimulation condition. Specifically here we show the difference in estimated marginal means between sham and HF-rTMS||A MMANOVA analysis using an unstructured covariance structure examined changes in SCL between groups, experimental types of neurostimulation, and their interaction, controlling for baseline, racial background, coil to cortex distance, and headache||.787|.198|.001
70993447|NCT04348591|141495549|SUPERIORITY||Mean Difference (Final Values)|0.469|STANDARD_ERROR_OF_MEAN|0.144||0.002|TWO_SIDED|95.0|0.182|0.757|||Mixed Models Analysis|This is the main effect of neurostimulation administered, specifically comparing estimated marginal means for sham and LF-rTMS||A MMANOVA analysis using an unstructured covariance structure examined changes in SCL between groups, experimental types of neurostimulation, and their interaction, controlling for baseline, racial background, coil to cortex distance, and headache||.757|.182|.002
70993448|NCT04348591|141495549|SUPERIORITY||Mean Difference (Final Values)|0.73||||0.0005|TWO_SIDED||||||Mixed Models Analysis||mean difference between sham and HF-rTMS for misophonia participants only when downregulating misophonic sounds|The investigators tested the interaction between experimental neurostimulation (sham, active high frequency rTMS, active low frequency rTMS), instruction provided (listen to neutral sound; listen to aversive sound, listen to misophonic sound, downregulate aversive sound, downregulate misophonic sound), and group (misophonic, clinical control) as part of the same MMANOVA analysis described above (i.e., controlling for coil-to-cortex distance, racial background, baseline, \& presence of headache).||||.0005
70993449|NCT04348591|141495551|SUPERIORITY||Mean Difference (Final Values)|0.0563|STANDARD_ERROR_OF_MEAN|0.09853||0.57|TWO_SIDED|95.0|-0.14149|0.25411|||t-test, 2 sided|||An independent samples t-test was conducted to examine differences between groups in BOLD bilateral dlPFC signal during the regulation of misophonic versus aversive sounds. One outlier was removed from the misophonia group to avoid violating the normality assumption.||.25411|-.14149|.57
70993450|NCT04348591|141495552|SUPERIORITY||Mean Difference (Final Values)|0.037293|STANDARD_ERROR_OF_MEAN|0.131419||0.778|TWO_SIDED|95.0|-0.22667|0.301257|||t-test, 2 sided|50 degrees of freedom||An independent samples t-test was conducted to examine differences between groups in vmPFC activation that was greater when downregulating misophonic versus non-misophonic distress. One participant from each group was excluded for being an outlier||0.301257|-0.226670|.778
70993451|NCT04348591|141495553|SUPERIORITY||z score|4.69|||<|0.05|TWO_SIDED||||||mixed effects whole-brain using cluster|||Mixed effects (FSL's FLAME 1; Oxford Univ., UK) whole brain analyses using cluster correction following a voxel-wise Z-score threshold of 2.3.||||<.05
70993452|NCT04348591|141495554|SUPERIORITY||Mean Difference (Final Values)|-0.197|STANDARD_ERROR_OF_MEAN|0.283||0.49|TWO_SIDED|95.0|-0.766|0.372|||Mixed Models Analysis|This is the main effect from the MMANOVA analysis for group difference.||The MMANOVA analysis of SUDS used a Toeplitz covariance structure. The outcome variable was the difference between SUDS after each sound presentation and baseline, controlling for racial background, headache, and coil to cortex difference. Two participants were excluded from this analysis, one in each condition, because they provided outlier data.||.372|-.766|.49
70993453|NCT04348591|141495554|SUPERIORITY||Mean Difference (Final Values)|0.909|STANDARD_ERROR_OF_MEAN|0.147|<|1e-07|TWO_SIDED|95.0|0.62|1.97||This p-value corresponds to the difference between sham and HF-rTMS stimulation|Mixed Models Analysis|||The MMANOVA analysis of SUDS used a Toeplitz covariance structure. This analysis presents the main effect of neurostimulation experimental condition. The outcome variable was the difference between SUDS after each sound presentation and baseline, controlling for racial background, headache, and coil to cortex difference. Two participants were excluded from this analysis, one in each condition, because they provided outlier data.||1.97|.62|<.0000001
70993454|NCT04348591|141495554|SUPERIORITY||Mean Difference (Final Values)|0.331|STANDARD_ERROR_OF_MEAN|0.139||0.018|TWO_SIDED|95.0|0.057|0.605||The test corresponds to the difference between sham and LF-rTMS|Mixed Models Analysis|||The MMANOVA analysis of SUDS used a Toeplitz covariance structure. This analysis presents the main effect of neurostimulation experimental condition. The outcome variable was the difference between SUDS after each sound presentation and baseline, controlling for racial background, headache, and coil to cortex difference. Two participants were excluded from this analysis, one in each condition, because they provided outlier data.||.605|.057|.018
70993455|NCT04348591|141495554|SUPERIORITY||Mean Difference (Final Values)|1.02|||<|1e-06|TWO_SIDED||||||Mixed Models Analysis||For participants with misophonia difference in distress produced by a misophonic sound when downregulating misophonic sounds while receiving sham vs.HF-rTMS|The MMANOVA analysis of SUDS used a Toeplitz covariance structure. This analysis presents the interaction effect of group by neurostimulation experimental condition. The outcome variable was the difference between SUDS after each sound presentation and baseline, controlling for racial background, headache, and coil to cortex difference. Two participants were excluded from this analysis, one in each condition, because they provided outlier data.||||<.000001
70993456|NCT04348591|141495555|SUPERIORITY||Mean Difference (Final Values)|9.53|STANDARD_ERROR_OF_MEAN|1.92|<|0.001|TWO_SIDED|||||This is the result corresponding to the main effect of time in the repeated measures ANCOVA|ANCOVA|||Repeated measures ANOVA (controlling for racial background)||||<.001
70993457|NCT04348591|141495555|SUPERIORITY||||||>|0.012|||||||ANCOVA|This analysis corresponds to the main effect of group.||Repeated measures ANOVA (controlling for racial background)||||>.012
70993458|NCT04348591|141495556|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||An independent samples t-test was conducted to examine between group differences at the intake assessment on the PROMIS Anxiety subscale||||.78
70993459|NCT04348591|141495556|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||An independent samples t-test was conducted to examine between group differences at the intake assessment on the PROMIS Depression subscale||||.29
71099158|NCT05033561|141707054|NON_INFERIORITY|Non-inferiority would be verified if the lower bound of the two-sided 95% CI around each difference (shorter interval minus standard interval) is greater than -10%.||||||0.05||||||This is the nominal alpha level for the two-sided confidence interval comparison.|Miettinen-Nurminen|Pairwise comparisons with two-sided Miettinen-Nurminen confidence intervals.||This study was designed to demonstrate the non-inferiority of Group A (1-week interval nOPV2 administration) and Group B (2-weeks interval nOPV2 administration) versus Group C (standard 4-week interval).||||0.05
70993460|NCT04348591|141495556|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||An independent samples t-test was conducted to examine between group differences at the intake assessment on the PROMIS Fatigue subscale||||.64
70993461|NCT04348591|141495556|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||An independent samples t-test was conducted to examine between group differences at the intake assessment on the PROMIS Sleep disturbance subscale||||.16
70993462|NCT04348591|141495556|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||An independent samples t-test was conducted to examine between group differences at the intake assessment on the PROMIS Ability to partake in social roles subscale||||.56
70993463|NCT01778127|141495561|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||t-test, 2 sided|||||||0.90
70993464|NCT01778127|141495561|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||t-test, 2 sided|||||||0.18
70993465|NCT01778127|141495561|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||t-test, 2 sided|||||||0.14
70993466|NCT01778127|141495562|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||t-test, 2 sided|||||||0.49
70993467|NCT01778127|141495562|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||t-test, 2 sided|||||||0.84
71039891|NCT02654145|141587828|SUPERIORITY||Mean Difference (Final Values)|-1.34|||<|0.001|TWO_SIDED|95.0|-1.68|-1.0||p- value for Difference (Mepo-Placebo) calculated based on the Historical Placebo estimate of -0.11 (Standard Error: 0.14), which was estimated from a meta-analysis of studies NCT01691521 and NCT02281318 using Placebo participants who previously used|Mixed Model Repeated Measures||Difference (Mepo-Placebo) calculated based on the Historical Placebo estimate of -0.11 (Standard Error: 0.14), which was estimated from a meta-analysis of studies NCT01691521 and NCT02281318 using Placebo participants who previously used Xolair.|||-1.00|-1.68|<0.001
71099159|NCT05033561|141707054|NON_INFERIORITY|Non-inferiority would be verified if the lower bound of the two-sided 95% CI around each difference (shorter interval minus standard interval) is greater than -10%.||||||0.05||||||This is the nominal alpha level for the two-sided confidence interval comparison.|Miettinen-Nurminen|Pairwise comparisons with two-sided Miettinen-Nurminen confidence intervals.||This study was designed to demonstrate the non-inferiority of Group A (1-week interval nOPV2 administration) and Group B (2-weeks interval nOPV2 administration) versus Group C (standard 4-week interval).||||0.05
71099160|NCT01313676|141707075|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.878||||0.137|TWO_SIDED|95.0|0.739|1.042|||Cox Proportional Hazards Model|||||1.042|0.739|0.137
70993468|NCT01778127|141495562|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||t-test, 2 sided|||||||0.37
70993469|NCT01778127|141495563|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
70993470|NCT01778127|141495563|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED||||||t-test, 2 sided|||||||0.63
70993471|NCT01778127|141495563|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||t-test, 2 sided|||||||0.09
70993472|NCT01778127|141495564|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||t-test, 2 sided|||||||0.49
71099161|NCT01313676|141707075|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|12.2|||||TWO_SIDED|95.0|-4.2|26.1|||||Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||26.1|-4.2|
70993473|NCT01778127|141495564|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||t-test, 2 sided|||||||0.43
70993474|NCT01778127|141495564|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||t-test, 2 sided|||||||0.89
70993475|NCT01778127|141495565|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||t-test, 2 sided|||||||0.61
71039892|NCT02654145|141587830|SUPERIORITY||Rate ratio|0.36|||<|0.001|TWO_SIDED|95.0|0.28|0.47|||Generalised Estimating Equations||Analysis performed using generalized estimating equation (GEE) model assuming a negative binomial distribution with a covariate of treatment period (pre-treatment , on- and off-treatment), logarithm of time as an offset variable|||0.47|0.28|<0.001
71039893|NCT02637141|141587832|SUPERIORITY|P-values smaller than 0.05 were considered statistically significant.|LS Mean Difference|-2.49|STANDARD_ERROR_OF_MEAN|7.1||0.7271|TWO_SIDED|95.0|-16.82|11.83|||ANCOVA|The model included baseline VH:CD ratio, site, and sex as covariates and treatment group as a fixed effect.||||11.83|-16.82|0.7271
71039894|NCT02637141|141587832|SUPERIORITY|P-values smaller than 0.05 were considered statistically significant.|LS Mean Difference|6.39|STANDARD_ERROR_OF_MEAN|6.67||0.3438|TWO_SIDED|95.0|-7.07|19.85|||ANCOVA|The model included baseline VH:CD ratio, site, and sex as covariates and treatment group as a fixed effect.||||19.85|-7.07|0.3438
71099162|NCT01313676|141707075|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.911||||0.284|TWO_SIDED|95.0|0.767|1.081|||Cox Proportional Hazards Model|||||1.081|0.767|0.284
70993476|NCT01778127|141495565|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||t-test, 2 sided|||||||0.64
70993477|NCT01778127|141495565|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||t-test, 2 sided|||||||0.99
70993478|NCT01778127|141495566|SUPERIORITY_OR_OTHER|||||||0.69|TWO_SIDED||||||t-test, 2 sided|||||||0.69
70993479|NCT01778127|141495566|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||t-test, 2 sided|||||||0.89
70993480|NCT01778127|141495566|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||t-test, 2 sided|||||||0.59
70993481|NCT01778127|141495567|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||t-test, 2 sided|||||||0.78
70993482|NCT01778127|141495567|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||t-test, 2 sided|||||||0.95
70993483|NCT01778127|141495567|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||t-test, 2 sided|||||||0.83
70993484|NCT01778127|141495568|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||t-test, 2 sided|||||||0.83
70993485|NCT01778127|141495568|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||t-test, 2 sided|||||||0.83
70993486|NCT01778127|141495568|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||t-test, 2 sided|||||||0.99
70993487|NCT01778127|141495569|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||t-test, 2 sided|||||||0.44
70993488|NCT01778127|141495569|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||t-test, 2 sided|||||||0.19
70993489|NCT01778127|141495569|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||t-test, 2 sided|||||||0.54
70993490|NCT01778127|141495570|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||t-test, 2 sided|||||||0.17
70993491|NCT01778127|141495570|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||t-test, 2 sided|||||||0.13
70993492|NCT01778127|141495570|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||t-test, 2 sided|||||||0.81
70993493|NCT01778127|141495571|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||t-test, 2 sided|||||||0.08
70993494|NCT01778127|141495571|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||t-test, 2 sided|||||||0.15
70993495|NCT01778127|141495571|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||t-test, 2 sided|||||||0.83
70993496|NCT01778127|141495572|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
70993497|NCT01778127|141495572|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||t-test, 2 sided|||||||0.11
70993498|NCT01778127|141495572|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||t-test, 2 sided|||||||0.81
70993499|NCT01348425|141495573|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin is +/- 10%, type I error is assumed to be 0.05, with a power of 0.8.|Mean Difference (Final Values)|0.7|STANDARD_DEVIATION|4.1|<|0.01|TWO_SIDED|95.0|-2.0|3.5||Schuirman's TOST equivalence test on change in stent length upon deployment between longer and shorter stents.|t-test, 2 sided|To test the hypothesis whether the percent change in stent length is contained within \[-10%, 10%\].||The alternative hypothesis is equivalence in mean change in stent length upon deployment between longer and shorter stents, i.e., the difference in mean change between the longer and shorter stents is close to 0. Thus, a small p-value indicates a 95% confidence interval covers 0.||3.5|-2.0|<0.01
70993500|NCT02104804|141495574|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.58|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.72|-0.45|||ANCOVA|||||-0.45|-0.72|<0.001
70993501|NCT02104804|141495575|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-6133.2|STANDARD_ERROR_OF_MEAN|781.06|<|0.001|TWO_SIDED|95.0|-7668.5|-4597.9|||ANCOVA|||||-4597.9|-7668.5|<0.001
70993502|NCT02104804|141495576|SUPERIORITY_OR_OTHER||Difference in Least squares mean|-39.11|STANDARD_ERROR_OF_MEAN|5.24|<|0.001|TWO_SIDED|95.0|-49.41|-28.82|||ANCOVA|||||-28.82|-49.41|<0.001
70993503|NCT02104804|141495577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.8||||0.002|TWO_SIDED|95.0|3.1|12.6|||Difference in proportions|||||12.6|3.1|0.002
70993504|NCT02104804|141495578|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-15.88|STANDARD_ERROR_OF_MEAN|2.88|<|0.001|TWO_SIDED|95.0|-21.53|-10.22|||ANCOVA|||||-10.22|-21.53|<0.001
71099163|NCT01313676|141707075|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|8.9|||||TWO_SIDED|95.0|-8.1|23.3|||||Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||23.3|-8.1|
70993505|NCT02104804|141495579|SUPERIORITY_OR_OTHER||Difference in Least squares mean|-0.13|STANDARD_ERROR_OF_MEAN|0.16||0.43|TWO_SIDED|95.0|-0.44|0.19|||ANCOVA|||||0.19|-0.44|0.430
70993506|NCT00751114|141495626|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.77|-0.42||An analysis of covariance (ANCOVA) was performed, with the HbA1c change from baseline to last on-treatment measurement as dependent variable, treatment as fixed effect and the corresponding baseline HbA1c value as covariate|ANCOVA||Difference (Insulin glargine - Sitagliptin)|"H0: no difference between insulin glargine mean HbA1c change and sitagliptin mean HbA1c change~H1: difference between insulin glargine mean HbA1c change and sitagliptin mean HbA1c change~Assuming:~* Estimated standard deviation of the change in HbA1c of 1.3%~* Expected mean difference to be detected of 0.4%~* Alpha risk of 5% (two-sided)~* Power of 90%~* Equal sample size in each treatment group (1:1 randomization)~A total number of 446 evaluable patients (223 in each group) was required"||-0.42|-0.77|<0.0001
70993507|NCT00406783|141495661|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANOVA|||||||<0.001
70993508|NCT00406783|141495662|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANOVA|||||||<0.001
70993509|NCT00064350|141495665|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0|||||Fisher Exact|||Compare the proportion of patients maintaining stable disease or objective response at 2 months after randomization between the two arms.||||0.005
70993510|NCT00064350|141495666|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||95.0|||||Log Rank|||Compare PFS between the Sorafenib arm and the placebo arm||||0.014
70993511|NCT00064350|141495667|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||95.0|||||Log Rank|||Compare OS between the Sorafenib arm and the placebo arm||||0.12
70993512|NCT03162055|141495787|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin -50 mL.|Least Square Mean Difference|-87.2|STANDARD_ERROR_OF_MEAN|13.3||0.9974|TWO_SIDED|97.5|-117.0|-57.4|||Repeated measures analysis|Change from baseline = Treatment + baseline FEV1 + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||-57.4|-117.0|0.9974
70993513|NCT03162055|141495788|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin -50 mL.|Least Square Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|13.1||0.0002|TWO_SIDED|97.5|-32.8|25.9|||Repeated measures analysis|Change from baseline = Treatment + baseline FEV1 + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean peak change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||25.9|-32.8|0.0002
70993514|NCT03162055|141495789|SUPERIORITY||Odds Ratio (OR)|2.3|||<|0.0001|TWO_SIDED|95.0|1.79|2.95|||Regression, Logistic|ln (1/(1-p))=Treatment+baseline FEV1+BR a/s MDI+stratification factor (prior treatment)+region.p=percentage of participants with increase of \>=100 mL.|Estimate of the log odds of being a responder in the GFF treatment group compared to the UV treatment group using a logistic regression.|||2.95|1.79|<0.0001
70993515|NCT03162055|141495790|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin -50 mL.|Least Square Mean Difference|-15.2|STANDARD_ERROR_OF_MEAN|19.4||0.0371|TWO_SIDED|95.0|-53.4|22.9|||Repeated measures analysis|Change from baseline = Treatment + baseline IC + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean peak change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||22.9|-53.4|0.0371
71039895|NCT02637141|141587833|SUPERIORITY||LS Mean Difference|-14.32|STANDARD_ERROR_OF_MEAN|19.85||0.4746|TWO_SIDED|95.0|-54.39|25.74|||ANCOVA|The model included baseline VH:CD ratio, site, and sex as covariates and treatment group as a fixed effect.||||25.74|-54.39|0.4746
71039896|NCT02637141|141587833|SUPERIORITY||LS Mean Difference|-41.24|STANDARD_ERROR_OF_MEAN|18.85||0.0343|TWO_SIDED|95.0|-79.28|-3.2|||ANCOVA|The model included baseline VH:CD ratio, site, and sex as covariates and treatment group as a fixed effect.||||-3.2|-79.28|0.0343
71039897|NCT02637141|141587835|SUPERIORITY||LS Mean Difference|4402.25|STANDARD_ERROR_OF_MEAN|1717.4||0.014|TWO_SIDED|95.0|936.39|7868.1|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||||7868.10|936.39|0.0140
71039898|NCT02637141|141587835|SUPERIORITY||LS Mean Difference|944.9|STANDARD_ERROR_OF_MEAN|1167.22||0.4228|TWO_SIDED|95.0|-1410.65|3300.44|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||||3300.44|-1410.65|0.4228
71039899|NCT02637141|141587836|SUPERIORITY||LS Mean Difference|17.8|STANDARD_ERROR_OF_MEAN|17.09||0.3034|TWO_SIDED|95.0|-16.68|52.29|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||Analysis of Change From Baseline in Anti-DGP-IgA||52.29|-16.68|0.3034
70993516|NCT03162055|141495791|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin -1.0 unit.|Least Square Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.59|-0.14|||Repeated measures analysis|TDI focal score = Treatment + Baseline Dyspnea Index + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean TDI focal score over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||-0.14|-0.59|<0.0001
70993517|NCT03162055|141495792|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin 0.1 unit.|Least Square Mean Difference|0.034|STANDARD_ERROR_OF_MEAN|0.023||0.0017|TWO_SIDED|95.0|-0.011|0.078|||Repeated measures analysis|Change from baseline = Treatment + baseline EMSCI score + BR a/s MDI + stratification factor (prior treatment) + region + TI + treatment by TI.|Estimate of the mean change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||0.078|-0.011|0.0017
70993518|NCT03162055|141495793|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin 0.1 unit.|Least Square Mean Difference|0.042|STANDARD_ERROR_OF_MEAN|0.024||0.0088|TWO_SIDED|95.0|-0.005|0.09|||Repeated measures analysis|Change from baseline = Treatment + baseline NiSCI score + BR a/s MDI + stratification factor (prior treatment) + region + TI + treatment by TI.|Estimate of the mean change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||0.090|-0.005|0.0088
70993519|NCT03162055|141495794|SUPERIORITY||Least Square Mean Difference|0.65|STANDARD_ERROR_OF_MEAN|0.2||0.9995|TWO_SIDED|95.0|0.26|1.04|||Repeated measures analysis|Change from baseline =Treatment + baseline rescue a/s MDI use + BR a/s MDI + stratification factor (prior treatment) + region + TI + treatment by TI.|Estimate of the mean change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||1.04|0.26|0.9995
71099164|NCT01313676|141707075|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.962||||0.655|TWO_SIDED|95.0|0.813|1.139|||Cox Proportional Hazards Model|||||1.139|0.813|0.655
71099165|NCT01313676|141707075|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|3.8|||||TWO_SIDED|95.0|-13.9|18.7|||||Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||18.7|-13.9|
71099166|NCT01313676|141707075|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.964||||0.681|TWO_SIDED|95.0|0.808|1.149|||Cox Proportional Hazards Model|||||1.149|0.808|0.681
70993520|NCT03162055|141495795|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin 2.0 unit.|Least Square Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|0.07|1.11|||Repeated measures analysis|Change from baseline = Treatment + baseline CAT score + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||1.11|0.07|<0.0001
70993521|NCT03162055|141495796|SUPERIORITY||Least Square Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|12.8||0.5516|TWO_SIDED|97.5|-30.3|27.0|||Repeated measures analysis|Change from baseline = Treatment + baseline FEV1 + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean peak change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||27.0|-30.3|0.5516
70993522|NCT01617655|141495797|SUPERIORITY_OR_OTHER||LS mean difference|-39.1|||<|0.0001|TWO_SIDED|95.0|-51.1|-27.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-27.1|-51.1|<0.0001
70993523|NCT01617655|141495798|SUPERIORITY_OR_OTHER||LS mean difference|-38.9|||<|0.0001|TWO_SIDED|95.0|-51.0|-26.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-26.9|-51|<0.0001
70993524|NCT01617655|141495799|SUPERIORITY_OR_OTHER||LS mean difference|-40.3|||<|0.0001|TWO_SIDED|95.0|-51.4|-29.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-29.3|-51.4|<0.0001
70993525|NCT01617655|141495800|SUPERIORITY_OR_OTHER||LS mean difference|-40.3|||<|0.0001|TWO_SIDED|95.0|-51.4|-29.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-29.2|-51.4|<0.0001
71039900|NCT02637141|141587836|SUPERIORITY||LS Mean Difference|-6.92|STANDARD_ERROR_OF_MEAN|15.46||0.6569|TWO_SIDED|95.0|-38.11|24.28|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||Analysis of Change From Baseline in Anti-DGP-IgA||24.28|-38.11|0.6569
71039901|NCT02637141|141587836|SUPERIORITY||LS Mean Difference|13.17|STANDARD_ERROR_OF_MEAN|26.77||0.6254|TWO_SIDED|95.0|-40.86|67.2|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||Analysis of Change From Baseline in Anti-DGP-IgG||67.20|-40.86|0.6254
71099167|NCT01313676|141707075|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|3.6|||||TWO_SIDED|95.0|-14.9|19.2|||||Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||19.2|-14.9|
71099168|NCT01313676|141707075|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.912||||0.299|TWO_SIDED|95.0|0.767|1.085|||Cox Proportional Hazards Model|||||1.085|0.767|0.299
71099169|NCT01313676|141707075|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|8.8|||||TWO_SIDED|95.0|-8.5|23.3|||||Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||23.3|-8.5|
71099170|NCT01313676|141707076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|3.4||0.019|TWO_SIDED|95.0|1.0|15.0|||Mixed Models Analysis|||||15|1|0.019
71099171|NCT01313676|141707076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|3.5||0.026|TWO_SIDED|95.0|1.0|14.0|||Mixed Models Analysis|||||14|1|0.026
71099172|NCT01313676|141707076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|3.4||0.654|TWO_SIDED|95.0|-8.0|5.0|||Mixed Models Analysis|||||5|-8|0.654
71099173|NCT01313676|141707076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|3.4||0.913|TWO_SIDED|95.0|-6.0|7.0|||Mixed Models Analysis|||||7|-6|0.913
71099174|NCT01313676|141707076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|STANDARD_ERROR_OF_MEAN|3.4||0.004|TWO_SIDED|95.0|3.0|16.0|||Mixed Models Analysis|||||16|3|0.004
70923378|NCT03052608|141338192|SUPERIORITY||Mean Difference (Net)|2.58||||0.0553|TWO_SIDED|95.0|-0.06|5.22|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Emotional Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||5.22|-0.06|0.0553
70923379|NCT03052608|141338192|SUPERIORITY||Mean Difference (Net)|-3.18||||0.0588|TWO_SIDED|95.0|-6.47|0.12|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Cognitive Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||0.12|-6.47|0.0588
70923380|NCT03052608|141338192|SUPERIORITY||Mean Difference (Net)|2.27||||0.2118|TWO_SIDED|95.0|-1.3|5.85|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Social Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||5.85|-1.30|0.2118
70923381|NCT03052608|141338192|SUPERIORITY||Mean Difference (Net)|-5.67||||0.0032|TWO_SIDED|95.0|-9.42|-1.92|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Fatigue. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-1.92|-9.42|0.0032
70923382|NCT03052608|141338192|SUPERIORITY||Mean Difference (Net)|-7.86|||<|0.0001|TWO_SIDED|95.0|-9.86|-5.86|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Nausea and Vomiting. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-5.86|-9.86|<0.0001
70923383|NCT03052608|141338192|SUPERIORITY||Mean Difference (Net)|1.16||||0.531|TWO_SIDED|95.0|-2.49|4.82|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Pain. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||4.82|-2.49|0.5310
70993526|NCT01617655|141495801|SUPERIORITY_OR_OTHER||LS mean difference|-30.3|||<|0.0001|TWO_SIDED|95.0|-39.7|-20.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-20.9|-39.7|<0.0001
71099175|NCT01313676|141707077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.926||||0.475|TWO_SIDED|95.0|0.75|1.143|||Cox Proportional Hazards Model|||||1.143|0.750|0.475
71099176|NCT01313676|141707077|SUPERIORITY_OR_OTHER||Percent reduction in risk of CV event|7.4|||||TWO_SIDED|95.0|-14.3|25.0|||||Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||25.0|-14.3|
71099177|NCT01313676|141707077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.896||||0.317|TWO_SIDED|95.0|0.723|1.111|||Cox Proportional Hazards Model|||||1.111|0.723|0.317
71099178|NCT01313676|141707077|SUPERIORITY_OR_OTHER||Percent reduction in risk of CV event|10.4|||||TWO_SIDED|95.0|-11.1|27.7|||||Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||27.7|-11.1|
70923384|NCT03052608|141338192|SUPERIORITY||Mean Difference (Net)|1.72||||0.3602|TWO_SIDED|95.0|-1.98|5.43|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Dyspnoea. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||5.43|-1.98|0.3602
70923385|NCT03052608|141338192|SUPERIORITY||Mean Difference (Net)|-7.95|||<|0.0001|TWO_SIDED|95.0|-11.25|-4.64|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Insomnia. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-4.64|-11.25|<0.0001
70923386|NCT03052608|141338192|SUPERIORITY||Mean Difference (Net)|-9.21|||<|0.0001|TWO_SIDED|95.0|-11.8|-6.62|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Appetite Loss. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-6.62|-11.80|<0.0001
70923387|NCT03052608|141338192|SUPERIORITY||Mean Difference (Net)|-4.93||||0.0198|TWO_SIDED|95.0|-9.07|-0.79|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Constipation. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-0.79|-9.07|0.0198
71099179|NCT01313676|141707077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.988||||0.908|TWO_SIDED|95.0|0.802|1.217|||Cox Proportional Hazards Model|||||1.217|0.802|0.908
70993527|NCT01617655|141495802|SUPERIORITY_OR_OTHER||LS mean difference|-30.2|||<|0.0001|TWO_SIDED|95.0|-39.7|-20.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-20.7|-39.7|<0.0001
70993528|NCT01617655|141495803|SUPERIORITY_OR_OTHER||LS mean difference|-35.8|||<|0.0001|TWO_SIDED|95.0|-46.3|-25.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-25.3|-46.3|<0.0001
70993529|NCT01617655|141495804|SUPERIORITY_OR_OTHER||LS mean difference|-35.5|||<|0.0001|TWO_SIDED|95.0|-46.2|-24.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-24.9|-46.2|<0.0001
70993530|NCT01617655|141495805|SUPERIORITY_OR_OTHER||LS mean difference|-28.4|||<|0.0001|TWO_SIDED|95.0|-37.3|-19.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.6|-37.3|<0.0001
70993531|NCT01617655|141495806|SUPERIORITY_OR_OTHER||LS mean difference|-30.2|||<|0.0001|TWO_SIDED|95.0|-39.2|-21.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-21.1|-39.2|<0.0001
70993532|NCT01617655|141495807|SUPERIORITY_OR_OTHER||LS mean difference|-34.5|||<|0.0001|TWO_SIDED|95.0|-44.8|-24.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-24.1|-44.8|<0.0001
70993533|NCT01617655|141495808|SUPERIORITY_OR_OTHER||LS mean difference|-27.8|||<|0.0001|TWO_SIDED|95.0|-36.2|-19.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.4|-36.2|<0.0001
70993534|NCT01617655|141495809|SUPERIORITY_OR_OTHER||LS mean difference|-39.1|||<|0.0001|TWO_SIDED|95.0|-53.6|-24.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-24.6|-53.6|<0.0001
70993535|NCT01617655|141495810|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.7||||0.0016|TWO_SIDED|95.0|2.5|53.5||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||53.5|2.5|0.0016
71099180|NCT01313676|141707077|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|1.2|||||TWO_SIDED|95.0|-21.7|19.8|||||Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||19.8|-21.7|
71099181|NCT01313676|141707077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.033||||0.763|TWO_SIDED|95.0|0.834|1.281|||Cox Proportional Hazards Model|||||1.281|0.834|0.763
71099182|NCT01313676|141707077|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|-3.3|||||TWO_SIDED|95.0|-28.1|16.6|||||Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||16.6|-28.1|
71099183|NCT01313676|141707077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.938||||0.545|TWO_SIDED|95.0|0.761|1.155|||Cox Proportional Hazards Model|||||1.155|0.761|0.545
71099184|NCT01313676|141707077|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|6.2|||||TWO_SIDED|95.0|-15.5|23.9|||||Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||23.9|-15.5|
70993536|NCT01617655|141495811|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.9||||0.0014|TWO_SIDED|95.0|2.6|54.9||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||54.9|2.6|0.0014
70993537|NCT01617655|141495812|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-14.8||||0.0164|TWO_SIDED|95.0|-26.9|-2.7||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-2.7|-26.9|0.0164
70993538|NCT01617655|141495813|SUPERIORITY_OR_OTHER||LS mean difference|3.7||||0.2745|TWO_SIDED|95.0|-2.9|10.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||10.2|-2.9|0.2745
71099185|NCT02935036|141707084|SUPERIORITY||LS Mean Difference|1.33||||0.5947|TWO_SIDED||||||ANOVA|||||||0.5947
71099186|NCT02935036|141707085|SUPERIORITY||LS Mean Difference|2.75||||0.2912|TWO_SIDED||||||ANOVA|||||||0.2912
71099187|NCT02935036|141707086|SUPERIORITY||Percent difference|2.4||||0.692|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.6920
71099188|NCT06844812|141707094|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|paired t-test||||||<0.001
71099189|NCT06844812|141707095|SUPERIORITY|||||||0.021|||||||t-test, 2 sided|paired t-test||||||0.021
71099190|NCT06844812|141707096|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|paired t-test||||||0.003
70993539|NCT05137730|141495828|OTHER||Ratio of geometric least squares means|0.78|||||TWO_SIDED|90.0|0.7109|0.8611|||||Least squares means (LSMs) were calculated by exponentiating the LSMs derived from the linear mixed effects model.|||0.8611|0.7109|
71099191|NCT06844812|141707097|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71099192|NCT06844812|141707098|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71099193|NCT00368849|141707111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.63|||||||ANCOVA|||The primary measures were analyzed as pretreatment and posttreatment difference scores using a series of analyses of covariance controlling for age. The results were screened for model violations (e.g., outliers). Preliminary analyses assured no treatment order effects by examining block by treatment interactions.||||0.63
71039902|NCT02637141|141587836|SUPERIORITY||LS Mean Difference|2.86|STANDARD_ERROR_OF_MEAN|21.66||0.8955|TWO_SIDED|95.0|-40.84|46.57|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||Analysis of Change From Baseline in Anti-DGP IgG||46.57|-40.84|0.8955
71039903|NCT02637141|141587837|SUPERIORITY||Ratio of LS Means|0.83|STANDARD_ERROR_OF_MEAN|0.11||0.161|TWO_SIDED|95.0|0.63|1.08|||Generalized Linear Mixed Model|Generalized linear mixed model with treatment group, site, sex, time (week), and time point-by-treatment group interaction as fixed effects.||Analysis of Total Weekly Bowel Movements at Week 12||1.08|0.63|0.1610
71039904|NCT02637141|141587837|SUPERIORITY||Ratio of LS Means|1.03|STANDARD_ERROR_OF_MEAN|0.13||0.781|TWO_SIDED|95.0|0.81|1.32|||Generalized Linear Mixed Model|Generalized linear mixed model with treatment group, site, sex, time (week), and time point-by-treatment group interaction as fixed effects.||||1.32|0.81|0.7810
71039905|NCT02637141|141587839|SUPERIORITY||LS Mean Difference|-13.44|STANDARD_ERROR_OF_MEAN|12.33||0.2761|TWO_SIDED|95.0|-37.66|10.77|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||||10.77|-37.66|0.2761
71039906|NCT02637141|141587839|SUPERIORITY||LS Mean Difference|-2.62|STANDARD_ERROR_OF_MEAN|11.66||0.8221|TWO_SIDED|95.0|-25.51|20.27|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||||20.27|-25.51|0.8221
71039907|NCT02637141|141587840|SUPERIORITY||LS Mean Difference|-2.76|STANDARD_ERROR_OF_MEAN|2.1||0.1908|TWO_SIDED|95.0|-6.89|1.3|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||||1.3|-6.89|0.1908
71039908|NCT02637141|141587840|SUPERIORITY||LS Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|1.98||0.4088|TWO_SIDED|95.0|-5.53|2.25|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||||2.25|-5.53|0.4088
71039909|NCT01943435|141587842|SUPERIORITY|For this superiority study, sample size estimation was based upon hypothesized changes in our primary outcome measure, the Swiss Spinal Stenosis (SSS) questionnaire. We calculated that a total sample size of 180 subjects (n=60 per group) would give us 80% power to detect a difference as small as 3.6 points on the Swiss Spinal Stenosis questionnaire score. Sample size was increased at the request of the funding agency without any interim analysis performed.|Mean Difference (Final Values)|0.3||||0.73|TWO_SIDED|95.0|-1.5|2.2|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||The primary analysis was a between-groups comparison of means using linear mixed models with SSS total score as the dependent variable, while adjusting for randomization stratification factors.||2.2|-1.5|0.73
71039910|NCT01943435|141587842|SUPERIORITY|For this superiority study, sample size estimation was based upon hypothesized changes in our primary outcome measure, the Swiss Spinal Stenosis (SSS) questionnaire. We calculated that a total sample size of 180 subjects (n=60 per group) would give us 80% power to detect a difference as small as 3.6 points on the Swiss Spinal Stenosis questionnaire score. Sample size was increased at the request of the funding agency without any interim analysis performed.|Mean Difference (Final Values)|-2.1||||0.02|TWO_SIDED|95.0|-3.9|-0.3|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||The primary analysis was a between-groups comparison of means using linear mixed models with SSS total score as the dependent variable, while adjusting for randomization stratification factors.||-0.3|-3.9|0.02
71099194|NCT00368849|141707112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.09|||||||ANCOVA|||The primary measures were analyzed as pretreatment and posttreatment difference scores using a series of analyses of covariance controlling for age. The results were screened for model violations (e.g., outliers). Preliminary analyses assured no treatment order effects by examining block by treatment interactions.||||0.09
71099195|NCT00368849|141707113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26||||0.46|||||||ANCOVA|||The primary measures were analyzed as pretreatment and posttreatment difference scores using a series of analyses of covariance controlling for age. The results were screened for model violations (e.g., outliers). Preliminary analyses assured no treatment order effects by examining block by treatment interactions.||||0.46
71099196|NCT00368849|141707114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.84|||||||ANCOVA|||The secondary measures were analyzed as pretreatment and posttreatment difference scores using a series of analyses of covariance controlling for age. The results were screened for model violations (e.g., outliers). Preliminary analyses assured no treatment order effects by examining block by treatment interactions.||||0.84
71039911|NCT01943435|141587842|SUPERIORITY|For this superiority study, sample size estimation was based upon hypothesized changes in our primary outcome measure, the Swiss Spinal Stenosis (SSS) questionnaire. We calculated that a total sample size of 180 subjects (n=60 per group) would give us 80% power to detect a difference as small as 3.6 points on the Swiss Spinal Stenosis questionnaire score. Sample size was increased at the request of the funding agency without any interim analysis performed.|Mean Difference (Final Values)|2.4||||0.01|TWO_SIDED|95.0|0.6|4.3|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||The primary analysis was a between-groups comparison of means using linear mixed models with SSS total score as the dependent variable, while adjusting for randomization stratification factors.||4.3|0.6|0.01
71039912|NCT01943435|141587843|SUPERIORITY||Mean Difference (Final Values)|87.0||||0.29|TWO_SIDED|95.0|-75.2|249.2|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This analysis consisted of a between-groups comparison of means using linear mixed models with SPWT as the dependent variable, while adjusting for randomization stratification factors.||249.2|-75.2|0.29
71039913|NCT01943435|141587843|SUPERIORITY||Mean Difference (Final Values)|129.7||||0.1|TWO_SIDED|95.0|-27.2|286.6|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This analysis consisted of a between-groups comparison of means using linear mixed models with SPWT as the dependent variable, while adjusting for randomization stratification factors.||286.6|-27.2|0.10
71099197|NCT00368849|141707115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77||||0.76|||||||ANCOVA|||The secondary measures were analyzed as pretreatment and posttreatment difference scores using a series of analyses of covariance controlling for age. The results were screened for model violations (e.g., outliers). Preliminary analyses assured no treatment order effects by examining block by treatment interactions.||||0.76
71099198|NCT02006836|141707116|SUPERIORITY_OR_OTHER|||||||0.005|||||||t-test, 1 sided|||H0: GI of pomelo for diabetic patients - GI of pomelo for healthy people = 0 H1: GI of pomelo for diabetic patients - GI of pomelo for healthy people \> 0 α=5%||||0.005
71099199|NCT02006836|141707117|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||"H0：∆g after breakfast- ∆g before breakfast = 0 H1：∆g after breakfast- ∆g before breakfast \> 0 α=5%~* g of breasfast without pomelo=mean of 3 days of postprandial blood glucose after breakfast - mean of 3 days of blood glucose before this breakfast.~* g of breasfast with pomelo=mean of 3 days of postprandial blood glucose after breakfast - mean of 3 days of blood glucose before this breakfast."||||>0.05
71099200|NCT02006836|141707118|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||"H0：∆g after lunch - ∆g before lunch = 0 H1：∆g after lunch - ∆g before lunch \> 0 α=5%~* g of lunch without pomelo=mean of 3 days of postprandial blood glucose after lunch - mean of 3 days of blood glucose before this lunch.~* g of lunch with pomelo=mean of 3 days of postprandial blood glucose after lunch - mean of 3 days of blood glucose before this lunch."||||>0.05
71099201|NCT02006836|141707119|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||"H0：∆g after dinner- ∆g before dinner = 0 H1：∆g after dinner- ∆g before dinner \> 0 α=5%~* g of dinner without pomelo=mean of 3 days of postprandial blood glucose after dinner - mean of 3 days of blood glucose before this dinner.~* g of dinner with pomelo=mean of 3 days of postprandial blood glucose after dinner - mean of 3 days of blood glucose before this dinner."||||>0.05
71099202|NCT02006836|141707120|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||H0: AUC||||>0.05
70993540|NCT05137730|141495829|OTHER||Dose effect|1.5395|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|1.2929|1.7862||||||A linear regression model was used, including sequence and period as fixed effects, subject within sequence as a random effect, and ln(dose) as a covariate.||1.7862|1.2929|
70993541|NCT05137730|141495830|OTHER||Ratio of geometric least squares means|0.84|||||TWO_SIDED|90.0|0.7576|0.9375|||||LSMs were calculated by exponentiating the LSMs derived from the linear mixed effects model.|||0.9375|0.7576|
70993542|NCT05137730|141495831|OTHER||Dose effect|1.2823|STANDARD_ERROR_OF_MEAN|0.1072|||TWO_SIDED|95.0|1.0431|1.5215||||||A linear regression model using was used, including sequence and period as fixed effects, subject within sequence as a random effect, and ln(dose) as a covariate.||1.5215|1.0431|
70993543|NCT05137730|141495832|OTHER||Ratio of geometric least squares means|0.81|||||TWO_SIDED|90.0|0.7462|0.8893|||||LSMs were calculated by exponentiating the LSMs derived from the linear mixed effects model.|||0.8893|0.7462|
70993544|NCT05137730|141495833|OTHER||Dose effect|1.0937|STANDARD_ERROR_OF_MEAN|0.0763|||TWO_SIDED|95.0|0.938|1.2493||||||A linear regression model was used, including sequence and period as fixed effects, subject within sequence as a random effect, and ln(dose) as a covariate.||1.2493|0.9380|
70993545|NCT04724733|141495840|SUPERIORITY||||||>|0.05|||||||t-test, 1 sided|||||||>0.05
70993546|NCT04724733|141495840|SUPERIORITY||||||>|0.05|||||||t-test, 1 sided|||||||>0.05
70993547|NCT04724733|141495840|SUPERIORITY|||||||0.0172|||||||t-test, 1 sided|||||||0.0172
70993548|NCT04724733|141495841|SUPERIORITY|||||||0.032|||||||t-test, 1 sided|||||||.0320
70993549|NCT04724733|141495841|SUPERIORITY||||||>|0.05|||||||t-test, 1 sided|||||||>0.05
71099203|NCT05058456|141707128|OTHER|The primary safety hypothesis is: H0: ΠS \> PGS vs. HA: ΠS ≤ PGS where ΠS is the proportion of patients who experience a MAE within 30 days of procedure and PGS is the Safety Performance Goal. All subjects in whom a Mini S IVL catheter was introduced into the vasculature will be included in the analysis (i.e., it is an intent-to-treat analysis). The hypothesis will be tested using a one-sided Exact Binomial Test at α=0.025.|||||<|0.025|||||||Fisher Exact|||||||<.025
70993550|NCT04724733|141495841|SUPERIORITY|||||||0.0008|||||||t-test, 1 sided|||||||0.0008
70993551|NCT03341923|141495842|NON_INFERIORITY|"Difference (DT1MF-AMMF) of percentage of subjects rated as Optimal was provided with two-sided 95% confidence interval (CI). If lower limit of CI was above -10% as non-inferiority criteria, non-inferiority was to be demonstrated."|Difference in proportion|6.1||||0.0455|TWO_SIDED|95.0|0.2|11.9|||McNemar|||||11.9|0.2|0.0455
70993552|NCT03341923|141495842|SUPERIORITY|After demonstrating noninferiority, if lower limit of CI was above 0% as superiority criteria, superiority was to be demonstrated.|Difference in proportion|6.1||||0.0455|TWO_SIDED|95.0|0.2|11.9|||McNemar|||||11.9|0.2|0.0455
70993553|NCT02662985|141495861|SUPERIORITY||Median Difference (Net)|-3.18|STANDARD_ERROR_OF_MEAN|1.18||0.004|TWO_SIDED|95.0|-5.52|-0.85|||Mixed Models Analysis|mixed model repeated measures (MMRM)||GLOESS scores||-0.85|-5.52|0.0040
70993554|NCT02662985|141495862|SUPERIORITY||Odds Ratio (OR)|4.6|||<|0.0001|TWO_SIDED|95.0|2.38|8.89|||Regression, Logistic|Logistic regression using non-responder imputation||Proportion of patients with ACR 20 response at Week 12 (FAS)||8.89|2.38|<0.0001
70993555|NCT02662985|141495863|SUPERIORITY||Odds Ratio (OR)|9.65|||<|0.0001|TWO_SIDED|95.0|3.92|23.75|||Regression, Logistic|||Proportion of patients with ACR 50 response at Week 12 (FAS)||23.75|3.92|<0.0001
70993556|NCT02662985|141495864|SUPERIORITY||Adjusted mean of treatment difference|-0.67|STANDARD_ERROR_OF_MEAN|0.36||0.0327|TWO_SIDED|95.0|-1.374|0.043|||Regression, Logistic|||SPARCC||0.043|-1.374|0.0327
70993557|NCT01599754|141495881|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.3211|TWO_SIDED|95.0|0.66|1.147|||Log Rank|||||1.147|0.660|0.3211
70993558|NCT01599754|141495882|SUPERIORITY||Hazard Ratio (HR)|1.026||||0.9246|TWO_SIDED|95.0|0.6|1.756|||Log Rank|||||1.756|0.600|0.9246
70993559|NCT02128763|141495925|SUPERIORITY|||||||0.4|TWO_SIDED|95.0||||P value refers to difference between group on change in overall OSDI score (Row 1).|Regression, Linear|||||||0.40
70993560|NCT02128763|141495926|SUPERIORITY|||||||0.09|TWO_SIDED|95.0|||||Regression, Linear|||||||0.09
70993561|NCT02128763|141495927|SUPERIORITY|||||||0.77|TWO_SIDED|95.0|||||Regression, Linear|Pos hoc application of the Benjamini-Hochberg adjustment||||||0.77
70993562|NCT02128763|141495928|SUPERIORITY|||||||0.95|TWO_SIDED|95.0|||||Regression, Linear|||||||0.95
70993563|NCT02128763|141495929|SUPERIORITY|||||||0.051|TWO_SIDED|95.0|||||Regression, Linear|||||||0.051
70993564|NCT02128763|141495930|SUPERIORITY||||||<|0.001|TWO_SIDED|95.0|||||Regression, Linear|||||||<0.001
71099204|NCT05058456|141707129|OTHER|The primary effectiveness hypothesis is: H0: ΠE ≤ PGE vs. HA: ΠE \> PGE, where ΠE is the proportion of target lesions with technical success and PG is the effectiveness Performance Goal. One-sided statistical significance level of 0.025 = α. The hypothesis will be tested using a one-sided Exact Binomial Test.|||||<|0.025|||||||Fisher Exact|||||||<.025
71099205|NCT02933151|141707137|SUPERIORITY||Cox Proportional Hazard|1.03|||||TWO_SIDED|95.0|0.92|1.14|||||Reference group is usual care|||1.14|0.92|
70993565|NCT02128763|141495931|SUPERIORITY||||||<|0.001|TWO_SIDED|95.0|||||Regression, Linear|||||||<0.001
70993566|NCT02128763|141495932|SUPERIORITY|||||||0.4|TWO_SIDED|95.0|||||Regression, Linear|||||||0.40
70993567|NCT02128763|141495933|SUPERIORITY|||||||0.77|TWO_SIDED|95.0|||||Regression, Linear|||||||0.77
70993568|NCT02128763|141495934|SUPERIORITY|||||||0.95|TWO_SIDED|95.0|||||Regression, Linear|||||||0.95
70993569|NCT02128763|141495935|SUPERIORITY|||||||0.25|TWO_SIDED|95.0|||||Regression, Linear|||||||0.25
70993570|NCT02128763|141495936|SUPERIORITY|||||||0.61|TWO_SIDED|95.0|||||Regression, Linear|||||||0.61
70993571|NCT02128763|141495937|SUPERIORITY|||||||0.42|TWO_SIDED|95.0|||||Regression, Linear|||||||0.42
71039914|NCT01943435|141587843|SUPERIORITY||Mean Difference (Final Values)|-42.7||||0.61|TWO_SIDED|95.0|-205.4|120.0|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This analysis consisted of a between-groups comparison of means using linear mixed models with SPWT as the dependent variable, while adjusting for randomization stratification factors.||120.0|-205.4|0.61
71099206|NCT04392362|141707139|NON_INFERIORITY|The non-inferiority margin or delta was calculated as -0.12(-12%)|Risk Ratio (RR)|0.89||||0.8982|ONE_SIDED|95.0||||0.05 was the level of significance|Wilcoxon (Mann-Whitney)|||The null hypothesis is that the AHA method is inferior to the SIM method but not lower than a pre calculated noninferiority delta of -0.12 (-12 %) and a 95% one sided confidence interval. Only 33 (instead of 151 for a power of 95%) patients could be enrolled with 25 in the SIM and 8 in the AHA arms, which resulted in an estimated power test of 59.08%.||||0.8982
71099207|NCT03850431|141707147|OTHER||Odds Ratio (OR)|1.139||||0.145|TWO_SIDED|95.0|0.956|1.357|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.357|0.956|0.145
70993572|NCT02128763|141495938|SUPERIORITY|||||||0.6|TWO_SIDED|95.0|||||Chi-squared, Corrected|||||||0.60
70993573|NCT02128763|141495939|SUPERIORITY|||||||0.17|TWO_SIDED|95.0|||||Regression, Linear|||||||0.17
70993574|NCT02128763|141495940|SUPERIORITY|||||||0.02|TWO_SIDED|95.0|||||Regression, Linear|||||||0.02
70993575|NCT02128763|141495941|SUPERIORITY|||||||0.71|TWO_SIDED|95.0|||||Regression, Linear|||||||0.71
70993576|NCT02128763|141495942|SUPERIORITY|||||||0.66|TWO_SIDED|95.0|||||Regression, Linear|||||||0.66
70993577|NCT02128763|141495943|SUPERIORITY|||||||0.02|TWO_SIDED|95.0|||||Regression, Linear|||||||0.02
70993578|NCT00547378|141495959|SUPERIORITY|||||||0.016|||||||Cochran-Mantel-Haenszel|The two-sided Cochran-Mantel-Haenszel (CMH) test, stratified for center, was used to test the difference in responder rates between the 2 groups||||||0.016
70993579|NCT04105244|141495963|SUPERIORITY||Wald tests|0.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Intent-to-treat principle using linear mixed-effects models with random intercepts to examine longitudinal change scores for the outcome.||||||<0.05
71039915|NCT01943435|141587844|SUPERIORITY||Mean Difference (Final Values)|30.5||||0.03|TWO_SIDED|95.0|3.1|57.9|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This secondary analysis consisted of a between-groups comparison of means using linear regression with physical activity as the dependent variable (average number of minutes spent daily in activities \>1.5 METs), while adjusting for randomization stratification factors.||57.9|3.1|0.03
71099208|NCT03850431|141707147|OTHER||Odds Ratio (OR)|1.11||||0.298|TWO_SIDED|95.0|0.912|1.35|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.35|0.912|0.298
70993580|NCT04105244|141495964|SUPERIORITY||Wald tests|0.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Intent-to-treat principle using linear mixed-effects models with random intercepts to examine longitudinal change scores for the outcome.||||||<0.05
70993581|NCT04105244|141495965|SUPERIORITY||Wald test|0.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Intent-to-treat principle using linear mixed-effects models with random intercepts to examine longitudinal change scores for the outcome.||||||<0.05
70993582|NCT04105244|141495968|SUPERIORITY||Wald test|0.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Intent-to-treat principle using linear mixed-effects models with random intercepts to examine longitudinal change scores for the outcome.||||||<0.05
70993583|NCT04105244|141495969|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70993584|NCT02768194|141495984|SUPERIORITY||Mean Difference (Net)|-0.11||||0.5512|TWO_SIDED|95.0|-0.46|0.25||From the MMRM model with change from pre-dose as response, participant as a random effect; and treatment, period, day, location of sample in mouth (left or right) and treatment×day interaction as fixed effects; pre-dose mean SEM score as covariate.|Mixed Models Analysis||Difference is the first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||0.25|-0.46|0.5512
70993585|NCT02768194|141495984|SUPERIORITY||Mean Difference (Net)|-0.01||||0.9671|TWO_SIDED|95.0|-0.36|0.35||From the MMRM model with change from pre-dose as response, subject as a random effect; and treatment, period, day, location of sample in mouth (left or right) and treatment×day interaction as fixed effects; pre-dose mean SEM score as covariate.|Mixed Models Analysis||Difference is the first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||0.35|-0.36|0.9671
70993586|NCT02768194|141495984|SUPERIORITY||Mean Difference (Net)|-0.1||||0.583|TWO_SIDED|95.0|-0.46|0.26||From the MMRM model with change from pre-dose as response, subject as a random effect; and treatment, period, day, location of sample in mouth (left or right) and treatment×day interaction as fixed effects; pre-dose mean SEM score as covariate.|Mixed Models Analysis||Difference is the first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||0.26|-0.46|0.5830
70993587|NCT00975195|141495986|NON_INFERIORITY_OR_EQUIVALENCE|Upper limit of 95% confidence interval (CI) \<1.2 indicates non-inferiority of Fluticasone withdrawal compared with Fluticasone maintenance|Hazard Ratio (HR)|1.058||||0.3497|TWO_SIDED|95.0|0.941|1.189||Two-sided p-value to test superiority of fluticasone maintenance over fluticasone withdrawal if non-inferiority shown.|Chi-squared|Wald's chi-square test|Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance|||1.189|0.941|0.3497
71039916|NCT01943435|141587844|SUPERIORITY||Mean Difference (Final Values)|18.7||||0.16|TWO_SIDED|95.0|-7.6|45.0|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This secondary analysis consisted of a between-groups comparison of means using linear regression with physical activity as the dependent variable (average number of minutes spent daily in activities \>1.5 METs), while adjusting for randomization stratification factors.||45.0|-7.6|0.16
71039917|NCT01943435|141587844|SUPERIORITY||Mean Difference (Final Values)|11.8||||0.4|TWO_SIDED|95.0|-15.6|39.1|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This secondary analysis consisted of a between-groups comparison of means using linear regression with physical activity as the dependent variable (average number of minutes spent daily in activities \>1.5 METs), while adjusting for randomization stratification factors.||39.1|-15.6|0.40
71039918|NCT01328782|141587864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4||||0.074||95.0|1.4|2.94|||ANOVA|||||2.94|1.40|0.074
70993588|NCT00975195|141495987|SUPERIORITY_OR_OTHER||Rate ratio|1.05|STANDARD_ERROR_OF_MEAN|0.06||0.4441|TWO_SIDED|95.0|0.93|1.18|||Regression, Negative Binomial|Adjusted for log time at risk using log link function|Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance|||1.18|0.93|0.4441
70993589|NCT00975195|141495988|SUPERIORITY_OR_OTHER|||||||0.2269|TWO_SIDED||||||Fisher Exact|||||||0.2269
70993590|NCT00975195|141495989|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.202||||0.0849|TWO_SIDED|95.0|0.975|1.481|||Chi-squared|Wald's chi-square test|Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance|||1.481|0.975|0.0849
70993591|NCT00975195|141495990|SUPERIORITY_OR_OTHER||Rate ratio|1.15|STANDARD_ERROR_OF_MEAN|0.13||0.2291|TWO_SIDED|95.0|0.92|1.45|||Regression, Negative Binomial|Adjusted for log time at risk using log link function|Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance|||1.45|0.92|0.2291
70993592|NCT00975195|141495991|SUPERIORITY_OR_OTHER|||||||0.2083|TWO_SIDED||||||Fisher Exact|||||||0.2083
71039919|NCT01328782|141587864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.556||||0.556||95.0|-1.12|2.08|||ANOVA|||||2.08|-1.12|0.556
71099209|NCT03850431|141707147|OTHER||Odds Ratio (OR)|1.178||||0.127|TWO_SIDED|95.0|0.955|1.452|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.452|0.955|0.127
70993593|NCT00975195|141495992|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.035||||0.5562|TWO_SIDED|95.0|0.923|1.16|||Chi-squared|||||1.160|0.923|0.5562
70993594|NCT00975195|141495993|SUPERIORITY_OR_OTHER||Rate ratio|1.05|STANDARD_ERROR_OF_MEAN|0.06||0.4342|TWO_SIDED|95.0|0.93|1.18|||Regression, Negative binomial|Adjusted for log time at risk using log link function|Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance|||1.18|0.93|0.4342
70993595|NCT00975195|141495994|SUPERIORITY_OR_OTHER|||||||0.3155|TWO_SIDED||||||Fisher Exact|||||||0.3155
70993596|NCT00975195|141495996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.0134||0.0014|TWO_SIDED|95.0|-0.069|-0.017|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||-0.017|-0.069|0.0014
70993597|NCT00975195|141495997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.064|STANDARD_ERROR_OF_MEAN|0.034||0.0632|TWO_SIDED|95.0|-0.004|0.131|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||0.131|-0.004|0.0632
71039920|NCT01328782|141587864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93||||0.244||95.0|-0.64|2.49|||ANOVA|||||2.49|-0.64|0.244
71039921|NCT01328782|141587865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81||||0.014|TWO_SIDED|95.0|0.38|3.25|||ANOVA|||||3.25|0.38|0.014
71039922|NCT01328782|141587865|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.832||95.0|-1.3|1.61|||ANOVA|||||1.61|-1.30|0.832
71039923|NCT01328782|141587865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.66||||0.027||95.0|0.2|3.12|||ANOVA|||||3.12|0.20|0.027
71039924|NCT01328782|141587866|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Log Rank|||||||0.005
71039925|NCT01328782|141587866|SUPERIORITY_OR_OTHER|||||||0.3767||95.0|||||Log Rank|||||||0.3767
70993598|NCT00975195|141495998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.013|STANDARD_ERROR_OF_MEAN|0.055||0.8137|TWO_SIDED|95.0|-0.122|0.096|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||0.096|-0.122|0.8137
70993599|NCT00975195|141495999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.53|STANDARD_ERROR_OF_MEAN|3.17||0.2663|TWO_SIDED|95.0|-9.74|2.69|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||2.69|-9.74|0.2663
70993600|NCT00975195|141496000|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.06||0.0033|TWO_SIDED|95.0|0.05|0.27|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||0.27|0.05|0.0033
70993601|NCT00975195|141496001|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.03|STANDARD_ERROR_OF_MEAN|1.499||0.4914|TWO_SIDED|95.0|-3.98|1.91|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||1.91|-3.98|0.4914
71039926|NCT01328782|141587866|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Log Rank|||||||0.039
71039927|NCT01328782|141587867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042||||0.008||95.0|0.008|0.076|||ANOVA|||||0.076|0.008|0.008
71039928|NCT01328782|141587867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031||||0.078||95.0|-0.004|0.066|||ANOVA|||||0.066|-0.004|0.078
71039929|NCT01328782|141587867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011||||0.5321||95.0|-0.024|0.045|||ANOVA|||||0.045|-0.024|0.5321
71039930|NCT01328782|141587868|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared|||||||0.004
71039931|NCT01328782|141587868|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared|||||||0.004
71039932|NCT01328782|141587868|SUPERIORITY_OR_OTHER|||||||0.499||95.0|||||Chi-squared|||||||0.499
71039933|NCT04535986|141587869|SUPERIORITY||LS mean difference|0.0868|STANDARD_ERROR_OF_MEAN|0.0162|<|0.0001|TWO_SIDED|95.0|0.0551|0.1185||The analysis of covariance (ANCOVA) model was used to model the change from baseline FEV1 to average FEV1 AUC0-12h with treatment, region, background medication strata and smoking strata as fixed effects and baseline FEV1 as covariate.|ANCOVA|||||0.1185|0.0551|<0.0001
70993602|NCT00975195|141496002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.56|STANDARD_ERROR_OF_MEAN|1.669||0.349|TWO_SIDED|95.0|-4.84|1.71|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||1.71|-4.84|0.3490
70993603|NCT00975195|141496003|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|1.48||0.9262|TWO_SIDED|95.0|-2.77|3.04|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||3.04|-2.77|0.9262
70993604|NCT00975195|141496004|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.64|STANDARD_ERROR_OF_MEAN|1.716||0.1241|TWO_SIDED|95.0|-0.73|6.01|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||6.01|-0.73|0.1241
70993605|NCT00975195|141496005|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.048|STANDARD_ERROR_OF_MEAN|0.0123|<|0.0001|TWO_SIDED|95.0|-0.073|-0.024|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||-0.024|-0.073|<0.0001
70993606|NCT00975195|141496006|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.044|STANDARD_ERROR_OF_MEAN|0.0255||0.0855|TWO_SIDED|95.0|-0.094|0.006|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||0.006|-0.094|0.0855
70993607|NCT00975195|141496007|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.161|STANDARD_ERROR_OF_MEAN|0.045||0.0004|TWO_SIDED|95.0|-0.249|-0.073|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||-0.073|-0.249|0.0004
70993608|NCT00975195|141496008|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.97|STANDARD_ERROR_OF_MEAN|0.728||0.1838|TWO_SIDED|95.0|-0.46|2.4|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||2.40|-0.46|0.1838
70993609|NCT00975195|141496009|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.35|STANDARD_ERROR_OF_MEAN|0.702||0.0551|TWO_SIDED|95.0|-0.03|2.72|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||2.72|-0.03|0.0551
70993610|NCT00975195|141496010|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.845||0.4804|TWO_SIDED|95.0|-1.06|2.25|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||2.25|-1.06|0.4804
70993611|NCT00975195|141496011|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.22|STANDARD_ERROR_OF_MEAN|0.614||0.0467|TWO_SIDED|95.0|0.02|2.43|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||2.43|0.02|0.0467
70993612|NCT00975195|141496012|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.05||0.0223|TWO_SIDED|95.0|-0.21|-0.02|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||-0.02|-0.21|0.0223
70993613|NCT00363246|141496025|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||Chi-squared|||Health Status. No Wheelchair-related Fall Injuries vs. Wheelchair-related Fall Injuries.||||0.049
70993614|NCT00363246|141496025|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||Chi-squared|||Pain in last 4 weeks (interference with daily activities). No Wheelchair-related Fall Injuries vs. Wheelchair-related Fall Injuries.||||0.013
70993615|NCT00363246|141496025|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Chi-squared|||Pain when transfer. No Wheelchair-related Fall Injuries vs. Wheelchair-related Fall Injuries.||||0.0001
70993616|NCT00363246|141496025|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||t-test, 2 sided|||Energy level. No Wheelchair-related Fall Injuries vs. Wheelchair-related Fall Injuries.||||0.009
70993617|NCT00363246|141496026|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||Chi-squared|We used chi-squared test for categorical variable (most variables) and t-test (2-sided) for continuous variables (few variables).||Health Status. No Wheelchair-related Falls vs. Wheelchair-related Falls.||||0.033
70993618|NCT00363246|141496026|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||Chi-squared|||Pain in last 4 weeks (interference with daily activities). No Wheelchair-related Falls vs. Wheelchair-related Falls.||||0.013
70993619|NCT00363246|141496026|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Pain when transfer. No Wheelchair-related Falls vs. Wheelchair-related Falls.||||<0.001
70993620|NCT00363246|141496026|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||t-test, 2 sided|||Energy level. No Wheelchair-related Falls vs. Wheelchair-related Falls.||||0.007
70993621|NCT00099359|141496027|SUPERIORITY_OR_OTHER|||||||0.046||||||Overall comparison of 3 KM curves using an extension of the M-H test was performed. Results indicated a significant difference therefore a 2nd stage analysis was done to compare each pair of transmission rates, using 2-sample Mantel-Haenzel tests.|multiple comparison|Hochberg's modified Bonferroni method was used to adjust the significance level for comparisons between arms.||||||.046
70993622|NCT00099359|141496028|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Chi-squared|||||||.0001
70993623|NCT00099359|141496029|SUPERIORITY_OR_OTHER|||||||0.2432|||||||multiple comparison|||||||.2432
70993624|NCT00099359|141496030|SUPERIORITY_OR_OTHER|||||||0.49|||||||Chi-squared|||||||0.49
70993625|NCT00099359|141496033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5||||0.05|TWO_SIDED|95.0|0.24|1.01|||Regression, Logistic|Adjusted Odds ratio for treatment arm C (ZDV+3TC/NFV) association with Intrapartum Infection Status with Treatment Arm A (ZDV only) as reference group||||1.01|0.24|0.05
70993626|NCT00099359|141496033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.39||||0.01|TWO_SIDED|95.0|0.19|0.82||Adjusted odds ratio for association of treatment arm B (ZDV+NVP) with intrapartum infection status with Treatment Arm A (ZDV only) as reference.|Regression, Logistic|||||0.82|0.19|0.01
70993627|NCT00099359|141496033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.51||||0.03|TWO_SIDED|95.0|1.08|5.86|||Regression, Logistic|"Adjusted odds ratio for association of illegal substance use during pregnancy and intrapartum HIV infection status with NO being reference group."||||5.86|1.08|0.03
70993628|NCT00099359|141496033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.28|||<|0.0001|TWO_SIDED|95.0|1.56|3.35||Adjusted odds ratio for the association of continuous log10 viral load with intrapartum infection status|Regression, Logistic|||||3.35|1.56|<0.0001
71099210|NCT03850431|141707147|OTHER||Odds Ratio (OR)|1.117||||0.286|TWO_SIDED|95.0|0.911|1.37|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.37|0.911|0.286
70993629|NCT02720016|141496068|SUPERIORITY||Slope|-3.216|STANDARD_ERROR_OF_MEAN|1.3||0.016|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.016
70993630|NCT02720016|141496068|SUPERIORITY||Slope|-4.11|STANDARD_ERROR_OF_MEAN|1.308||0.002|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.002
70993631|NCT02720016|141496068|SUPERIORITY||Slope|-0.894|STANDARD_ERROR_OF_MEAN|1.296||0.492|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.492
70993632|NCT02720016|141496073|SUPERIORITY||Slope|-0.352|STANDARD_ERROR_OF_MEAN|2.172||0.872|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts and included partners nested within couples||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.872
70993633|NCT02720016|141496073|SUPERIORITY||Slope|-0.931|STANDARD_ERROR_OF_MEAN|2.296||0.686|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts and included partners nested within couples||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.686
70993634|NCT02720016|141496073|SUPERIORITY||Slope|-0.579|STANDARD_ERROR_OF_MEAN|2.256||0.798|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts and included partners nested within couples||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.798
70993635|NCT02720016|141496078|SUPERIORITY||Slope|-1.213|STANDARD_ERROR_OF_MEAN|2.518||0.631|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.631
70993636|NCT02720016|141496078|SUPERIORITY||Slope|-1.461|STANDARD_ERROR_OF_MEAN|2.495||0.56|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.560
70993637|NCT02720016|141496078|SUPERIORITY||Slope|-0.248|STANDARD_ERROR_OF_MEAN|2.536||0.922|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.922
71039934|NCT01559116|141587881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.252|0.309|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.309|0.252|<0.0001
71039935|NCT01559116|141587881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.087|0.143|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.143|0.087|<0.0001
71039936|NCT01559116|141587881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.082|0.139|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.139|0.082|<0.0001
71039937|NCT01559116|141587881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.277|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.249|0.306|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to placebo is calculated.|||0.306|0.249|<0.0001
71039938|NCT01559116|141587881|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.083|0.14|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.140|0.083|<0.0001
71039939|NCT01559116|141587881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.124|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.096|0.152|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.152|0.096|<0.0001
71039940|NCT01559116|141587881|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.079|0.136|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.136|0.079|<0.0001
71039941|NCT01559116|141587882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.319|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001||95.0|0.289|0.349|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.349|0.289|<0.0001
71039942|NCT01559116|141587882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.096|0.156|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.156|0.096|<0.0001
70993638|NCT04501679|141496106|SUPERIORITY||Strata-adjusted percentage difference|37.4|||<|0.0001|TWO_SIDED|95.0|26.3|48.5||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\<90 kg,\>=90 kg\]).|Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||48.5|26.3|<0.0001
70993639|NCT04501679|141496107|SUPERIORITY||Strata-adjusted percentage difference|28.5|||<|0.0001|TWO_SIDED|95.0|18.8|38.2||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||38.2|18.8|<0.0001
70993640|NCT04501679|141496108|SUPERIORITY||Strata-adjusted percentage difference|33.4|||<|0.0001|TWO_SIDED|95.0|24.3|42.4||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||42.4|24.3|<0.0001
70993641|NCT04501679|141496109|SUPERIORITY||Strata-adjusted percentage difference|30.0|||<|0.0001|TWO_SIDED|95.0|21.3|38.6||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\<90 kg,\>=90 kg\]).|Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||38.6|21.3|<0.0001
70993642|NCT04501679|141496110|SUPERIORITY||Strata-adjusted percentage difference|31.9|||<|0.0001|TWO_SIDED|95.0|20.7|43.2||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\<90 kg,\>=90 kg\]).|Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||43.2|20.7|<0.0001
71099211|NCT03850431|141707147|OTHER||Odds Ratio (OR)|1.179||||0.183|TWO_SIDED|95.0|0.925|1.504|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.504|0.925|0.183
70993643|NCT04501679|141496111|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.|Strata-adjusted percentage difference|27.9|||<|0.0001|TWO_SIDED|95.0|18.4|37.5||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|||37.5|18.4|<0.0001
70993644|NCT04501679|141496112|SUPERIORITY||Strata-adjusted percentage difference|18.8|||<|0.0001|TWO_SIDED|95.0|12.0|25.7||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||25.7|12.0|<0.0001
70993645|NCT00186056|141496114|SUPERIORITY_OR_OTHER||||||<|0.26|||||||ANOVA|Interaction of HAMD \* medication group F(2,26)=1.38, eta sq = .05||||||<.26
70993646|NCT04465396|141496161|EQUIVALENCE|Equivalence between pen injector and syringe injection was to be considered established if the 90% confidence interval (CI) of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.|Geometric Mean Ratio|109.22|||||TWO_SIDED|90.0|104.83|113.8|||||The analysis was performed using Proc Mixed in statistical software suite (SAS), with treatment, sequence, period, and participant within sequence as fixed effects.|||113.80|104.83|
70993647|NCT04465396|141496161|EQUIVALENCE|Equivalence between pen injector and syringe injection was to be considered established if the 90% CI of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.|Geometric Mean Ratio|113.99|||||TWO_SIDED|90.0|108.32|119.95|||||The analysis was performed using Proc Mixed in SAS, with treatment, sequence, period, and participant within sequence as fixed effects.|||119.95|108.32|
70993648|NCT04465396|141496162|EQUIVALENCE|Equivalence between pen injector and syringe injection was to be considered established if the 90% CI of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.|Geometric Mean Ratio|98.27|||||TWO_SIDED|90.0|88.5|109.11|||||The analysis was performed using Proc Mixed in SAS, with treatment, sequence, period, and participant within sequence as fixed effects.|||109.11|88.50|
71099212|NCT03850431|141707147|OTHER||Odds Ratio (OR)|1.2||||0.209|TWO_SIDED|95.0|0.903|1.595|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.595|0.903|0.209
70993649|NCT04465396|141496162|EQUIVALENCE|Equivalence between pen injector and syringe injection was to be considered established if the 90% CI of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.|Geometric Mean Ratio|92.48|||||TWO_SIDED|90.0|83.8|102.05|||||The analysis was performed using Proc Mixed in SAS, with treatment, sequence, period, and participant within sequence as fixed effects.|||102.05|83.80|
70993650|NCT04465396|141496163|EQUIVALENCE|Equivalence between pen injector and syringe injection was to be considered established if the 90% CI of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.|Geometric Mean Ratio|109.44|||||TWO_SIDED|90.0|105.51|113.51|||||The analysis was performed using Proc Mixed in SAS, with treatment, sequence, period, and participant within sequence as fixed effects.|||113.51|105.51|
70993651|NCT04465396|141496163|EQUIVALENCE|Equivalence between pen injector and syringe injection was to be considered established if the 90% CI of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.|Geometric Mean Ratio|118.4|||||TWO_SIDED|90.0|112.31|124.83|||||The analysis was performed using Proc Mixed in SAS, with treatment, sequence, period, and participant within sequence as fixed effects.|||124.83|112.31|
70993652|NCT00547638|141496177|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence is demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of DERMABOND HVD successful subjects) does not exceed 8%.|Difference in Proportion of Successes|-7.9|||||TWO_SIDED|95.0|-17.7|1.0|||Gart-Nam||The value for the Estimated Parameter is expressed as a percentage and is defined as the difference in the proportion of sucesses between study groups.|||1.0|-17.7|
70993653|NCT00547638|141496178|SUPERIORITY_OR_OTHER|||||||0.457||||||The total mHCS scores are summarized as proportion of subjects with good outcome (total scores of zero) and a comparison of treatment groups by Fisher Exact Test was performed to confirm differences in groups.|Fisher Exact|||||||0.457
70993654|NCT00547638|141496179|SUPERIORITY_OR_OTHER|||||||1||95.0||||Differences between treatment groups in the incidence rate of infection at Day 14 and Day 30 were compared using the Fisher's Exact Test.|Fisher Exact|||||||1.0000
70993655|NCT00547638|141496179|SUPERIORITY_OR_OTHER|||||||1||95.0||||Differences between treatment groups in the incidence rate of infection at Day 30 were compared using the Fisher's Exact Test.|Fisher Exact|||||||1.0000
70993656|NCT00547638|141496180|SUPERIORITY_OR_OTHER|||||||0.188||95.0||||Intent to treat population was analyzed.|Fisher Exact|||||||0.188
70993657|NCT00547638|141496180|SUPERIORITY_OR_OTHER|||||||0.883||95.0||||Intent to treat population was analyzed.|Fisher Exact|||||||0.883
70993658|NCT00547638|141496181|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0000
70993659|NCT05027516|141496187|SUPERIORITY||Ratio|1.05||||0.1026|TWO_SIDED|95.0|0.55|1.83|||Permutation testing|||||1.83|0.55|0.1026
71039943|NCT01559116|141587882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.089|0.149|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.149|0.089|<0.0001
71039944|NCT01559116|141587882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.323|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.293|0.354|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.354|0.293|<0.0001
71039945|NCT01559116|141587882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.101|0.161|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.161|0.101|<0.0001
71039946|NCT01559116|141587882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.109|0.169|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.169|0.109|<0.0001
70993660|NCT05027516|141496188|SUPERIORITY||Ratio|1.12||||1|TWO_SIDED|95.0|0.47|2.19|||Permutation testing|||For aminoglycosides||2.19|0.47|1
70993661|NCT05027516|141496188|SUPERIORITY||Ratio|1.01||||1|TWO_SIDED|95.0|0.69|1.44|||Permutation testing|||For betalactams||1.44|0.69|1
70993662|NCT05027516|141496188|SUPERIORITY||Ratio|3.79||||1|TWO_SIDED|95.0|0.05|20.15|||Permutation testing|||For bacitracin||20.15|0.05|1
70993663|NCT05027516|141496188|SUPERIORITY||Ratio|0.83||||1|TWO_SIDED|95.0|0.0|1.91|||Permutation testing|||For glycopeptides||1.91|0|1
70993664|NCT05027516|141496188|SUPERIORITY||Ratio|1.19||||1|TWO_SIDED|95.0|0.32|3.15|||Permutation testing|||For trimethoprim||3.15|0.32|1
70993665|NCT05027516|141496188|SUPERIORITY||Ratio|2.82||||1|TWO_SIDED|95.0|0.07|14.64|||Permutation testing|||For cationic antimicrobial peptides||14.64|0.07|1
70993666|NCT05027516|141496188|SUPERIORITY||Ratio|1.49||||1|TWO_SIDED|95.0|0.0|5.34|||Permutation testing|||For mupirocin||5.34|0|1
70993667|NCT05027516|141496188|SUPERIORITY||Ratio|1.2||||1|TWO_SIDED|95.0|0.0|3.22|||Permutation testing|||For metronidazole||3.22|0|1
70993668|NCT05027516|141496188|SUPERIORITY||Ratio|6.44||||1|TWO_SIDED|95.0|0.02|46.02|||Permutation testing|||For fluoroquinolones||46.02|0.02|1
70993669|NCT05027516|141496188|SUPERIORITY||Ratio|10.6||||1|TWO_SIDED|95.0|0.01|148.86|||Permutation testing|||For sulfonamides||148.86|0.01|1
70993670|NCT05027516|141496188|SUPERIORITY||Ratio|1.01||||0.5621|TWO_SIDED|95.0|0.79|1.27|||Permutation testing|||For tetracyclines||1.27|0.79|0.5621
70993671|NCT05027516|141496189|SUPERIORITY|||||||0.196|||||||Wilcoxon (Mann-Whitney)|||For streptococci||||0.196
70993672|NCT05027516|141496189|SUPERIORITY|||||||0.568|||||||Wilcoxon (Mann-Whitney)|||For streptococci||||0.568
70993673|NCT05027516|141496189|SUPERIORITY|||||||0.978|||||||Wilcoxon (Mann-Whitney)|||For Neisseria||||0.978
70993674|NCT05027516|141496189|SUPERIORITY|||||||0.184|||||||Wilcoxon (Mann-Whitney)|||For Neisseria||||0.184
71099213|NCT03850431|141707147|OTHER||Odds Ratio (OR)|1.144||||0.463|TWO_SIDED|95.0|0.799|1.638|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.638|0.799|0.463
70993675|NCT02365584|141496192|SUPERIORITY|"The assumptions required for the analysis of covariance (ANCOVA) were to be tested as follows:~* The equality of variances was to verified using the Levene's test. If it was significant AUC values were to be properly transformed.~* The linear relationship of AUC with the basal total score within treatment group was to be tested by a regression analysis.~* The parallelism of the regression lines between groups and the slope non zero value with the appropriate F tests."|Adjusted LS Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|17.7|=|0.5396|TWO_SIDED|95.0|-47.0|25.0|||ANCOVA|||Analysis of covariance (ANCOVA), where the AUC was the dependent and the independent was the baseline ESAS total score.||25|-47|=0.5396
70993676|NCT02193815|141496219|SUPERIORITY_OR_OTHER||Adjusted Mean Ratio|93.2|STANDARD_ERROR_OF_MEAN|0.075||0.3465|TWO_SIDED|95.0|80.43|107.99|||Mixed Models Analysis|||||107.99|80.43|0.3465
70993677|NCT02193815|141496220|SUPERIORITY_OR_OTHER||Adjusted Mean|165.88|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|143.12|192.25|||Mixed Models Analysis|||||192.25|143.12|<0.0001
70993678|NCT02193815|141496221|SUPERIORITY_OR_OTHER||Adjusted Mean|65.42|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|56.46|75.81|||Mixed Models Analysis|||||75.81|56.46|<0.0001
70993679|NCT02193815|141496222|SUPERIORITY_OR_OTHER||Adjusted Mean|93.04|STANDARD_ERROR_OF_MEAN|0.075||0.3349|TWO_SIDED|95.0|80.3|107.81|||Mixed Models Analysis|||||107.81|80.30|0.3349
70993680|NCT02193815|141496222|SUPERIORITY_OR_OTHER||Adjusted Mean|149.56|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|129.04|173.34|||Mixed Models Analysis|||||173.34|129.04|<0.0001
70993681|NCT02193815|141496222|SUPERIORITY_OR_OTHER||Adjusted Mean|106.51|STANDARD_ERROR_OF_MEAN|0.075||0.3991|TWO_SIDED|95.0|91.92|123.41|||Mixed Models Analysis|||||123.41|91.92|0.3991
70993682|NCT02193815|141496222|SUPERIORITY_OR_OTHER||Adjusted Mean|71.94|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|62.08|83.36|||Mixed Models Analysis|||||83.36|62.08|<0.0001
70993683|NCT02193815|141496223|SUPERIORITY_OR_OTHER||Adjusted Mean|96.04|STANDARD_ERROR_OF_MEAN|0.127||0.7529|TWO_SIDED|95.0|74.0|124.64|||Mixed Models Analysis|||||124.64|74.00|0.7529
70993684|NCT02193815|141496223|SUPERIORITY_OR_OTHER||Adjusted Mean|125.62|STANDARD_ERROR_OF_MEAN|0.147||0.1318|TWO_SIDED|95.0|92.96|169.75|||Mixed Models Analysis|||||169.75|92.96|0.1318
71099214|NCT03850431|141707147|OTHER||Odds Ratio (OR)|1.331||||0.074|TWO_SIDED|95.0|0.972|1.822|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.822|0.972|0.074
70993685|NCT02193815|141496223|SUPERIORITY_OR_OTHER||Adjusted Mean|103.35|STANDARD_ERROR_OF_MEAN|0.129||0.8009|TWO_SIDED|95.0|79.3|134.68|||Mixed Models Analysis|||||134.68|79.30|0.8009
70993686|NCT02193815|141496223|SUPERIORITY_OR_OTHER||Adjusted Mean|81.09|STANDARD_ERROR_OF_MEAN|0.124||0.1012|TWO_SIDED|95.0|62.94|104.47|||Mixed Models Analysis|||||104.47|62.94|0.1012
70993687|NCT00838916|141496231|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11|||||TWO_SIDED|95.0|-0.04|0.27|||ANCOVA|||||0.27|-0.04|
70993688|NCT00838916|141496231|NON_INFERIORITY_OR_EQUIVALENCE|To test whether the difference of least square means (albiglutide - insulin glargine) is equal to the pre-specified non-inferiority margin of 0.3%||||||0.0086||||||p-value is for non-inferiority testing of albiglutide versus insulin glargine|t-test, 1 sided|||||||0.0086
70993689|NCT00838916|141496231|SUPERIORITY_OR_OTHER|||||||0.1463||||||p-value is for superiority testing of albiglutide versus insulin glargine|t-test, 2 sided|The p-value is from a two-sided t-test to test whether the difference of least square means (albiglutide - insulin glargine) is equal to zero.||||||0.1463
70993690|NCT02164513|141496284|SUPERIORITY||Rate ratio|0.75|||<|0.001|TWO_SIDED|95.0|0.7|0.81||The adjusted p-values should be compared against a reference level of 0.05 in order to infer statistical significance for either of the comparisons.|Negative binomial model||Covariates of treatment group, sex, exacerbation history (\<=1, \>=2 moderate/severe), smoking status (Screening), geographical region and post-bronchodilator percent predicted Forced expiratory volume in 1 second (FEV1) (Screening) were used.|||0.81|0.70|<0.001
70993691|NCT02164513|141496284|SUPERIORITY||Rate ratio|0.85|||<|0.001|TWO_SIDED|95.0|0.8|0.9||The adjusted p-values should be compared against a reference level of 0.05 in order to infer statistical significance for either of the comparisons|Negative binomial model||Covariates of treatment group, sex, exacerbation history (\<=1, \>=2 moderate/severe), smoking status (Screening), geographical region and post-bronchodilator percent predicted Forced expiratory volume in 1 second (FEV1) (Screening) were used.|||0.90|0.80|<0.001
70993692|NCT02164513|141496285|SUPERIORITY||Mean Difference (Net)|0.097|STANDARD_ERROR_OF_MEAN|0.0061|<|0.001|TWO_SIDED|95.0|0.085|0.109||The adjusted p-value at Week 52 should be compared against a reference level of 0.05 in order to infer statistical significance for the comparison of FF/UMEC/VI versus (vs) FF/VI at Week 52.|Mixed Models Repeated Measures|||||0.109|0.085|<0.001
70993693|NCT02164513|141496286|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-2.4|-1.1||The adjusted p-value at Week 52 should be compared against a reference level of 0.05 in order to infer statistical significance for the comparison of FF/UMEC/VI vs FF/VI at Week 52.|Mixed Models Repeated Measures|||||-1.1|-2.4|<0.001
70993694|NCT02164513|141496287|SUPERIORITY||Hazard Ratio (HR)|0.85|||<|0.001|TWO_SIDED|95.0|0.8|0.91||The adjusted p-values should be compared against a reference level of 0.05 in order to infer statistical significance for either of the comparisons.|Cox proportional hazard model|||||0.91|0.80|<0.001
70993695|NCT02164513|141496287|SUPERIORITY||Hazard Ratio (HR)|0.84|||<|0.001|TWO_SIDED|95.0|0.78|0.91|||Cox proportional hazard model|||||0.91|0.78|<0.001
70993696|NCT02164513|141496288|SUPERIORITY||Rate ratio|0.68|||<|0.001|TWO_SIDED|95.0|0.62|0.75|||Negative binomial Model|||||0.75|0.62|<0.001
70993697|NCT02164513|141496289|SUPERIORITY||Hazard Ratio (HR)|0.77|||<|0.001|TWO_SIDED|95.0|0.7|0.85|||Cox proportional hazard model|||||0.85|0.70|<0.001
70993698|NCT02164513|141496290|SUPERIORITY||Rate Ratio|0.87||||0.064|TWO_SIDED|95.0|0.76|1.01|||Negative binomial model|||||1.01|0.76|0.064
70993699|NCT02164513|141496290|SUPERIORITY||Rate ratio|0.66|||<|0.001|TWO_SIDED|95.0|0.56|0.78|||Negative binomial model|||||0.78|0.56|<0.001
70993700|NCT00961662|141496306|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED|95.0|||||ANCOVA|||The HbA1c percent change at each study visit was calculated and then categorized as a binary response (i.e., responders and non-responders) for each subject based on the breakpoint to be used in the endpoint. Inferential statistics were prepared to compare the differences across the three treatments a using logistic regression model with the dose group and the HbA1c stratum included in the mode||||<0.05
71099215|NCT03850431|141707147|OTHER||Odds Ratio (OR)|1.169||||0.306|TWO_SIDED|95.0|0.867|1.577|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.577|0.867|0.306
71099216|NCT03850431|141707147|OTHER||Odds Ratio (OR)|1.15||||0.373|TWO_SIDED|95.0|0.845|1.565|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.565|0.845|0.373
71099217|NCT03850431|141707148|OTHER||Odds Ratio (OR)|0.923||||0.153|TWO_SIDED|95.0|0.826|1.03|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.03|0.826|0.153
71099218|NCT03850431|141707148|OTHER||Odds Ratio (OR)|0.911||||0.252|TWO_SIDED|95.0|0.777|1.068|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.068|0.777|0.252
71099219|NCT03850431|141707148|OTHER||Odds Ratio (OR)|0.941||||0.413|TWO_SIDED|95.0|0.815|1.088|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.088|0.815|0.413
71099220|NCT03850431|141707148|OTHER||Odds Ratio (OR)|0.946||||0.41|TWO_SIDED|95.0|0.83|1.079|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.079|0.83|0.41
71099221|NCT03850431|141707148|OTHER||Odds Ratio (OR)|0.887||||0.11|TWO_SIDED|95.0|0.766|1.027|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.027|0.766|0.11
71099222|NCT03850431|141707148|OTHER||Odds Ratio (OR)|0.833||||0.14|TWO_SIDED|95.0|0.654|1.062|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.062|0.654|0.14
71099223|NCT03850431|141707148|OTHER||Odds Ratio (OR)|0.882||||0.404|TWO_SIDED|95.0|0.657|1.184|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.184|0.657|0.404
71099224|NCT03850431|141707148|OTHER||Odds Ratio (OR)|0.743||||0.072|TWO_SIDED|95.0|0.538|1.027|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.027|0.538|0.072
71099225|NCT03850431|141707148|OTHER||Odds Ratio (OR)|0.778||||0.057|TWO_SIDED|95.0|0.6|1.008|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.008|0.6|0.057
70993701|NCT03006471|141496357|SUPERIORITY|||||||0.755||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.755
71099226|NCT03850431|141707148|OTHER||Odds Ratio (OR)|0.932||||0.637|TWO_SIDED|95.0|0.697|1.247|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.247|0.697|0.637
71099227|NCT01791205|141707178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.538||||0.1194|TWO_SIDED|95.0|0.65|19.33||The relation between retention rate and duration of disease for phase II was estimated with the Cox regression model.|Regression, Cox|||The relation between retention rate and DAS28 (\<2.6 vs \<3.2) was assayed with the Cox regression.||19.33|0.65|0.1194
71099228|NCT01791205|141707179|SUPERIORITY_OR_OTHER|||||||0.3895|||||||Regression, Cox|||||||0.3895
71099229|NCT01791205|141707180|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.211||||0.49|TWO_SIDED|95.0|0.703|2.086|||Regression, Logistic|||||2.086|0.703|0.4900
71099230|NCT01791205|141707181|SUPERIORITY_OR_OTHER||Delta|-0.042||||0.6908|TWO_SIDED|95.0|-0.251|0.167|||t-test, 2 sided|||||0.167|-0.251|0.6908
71099231|NCT01791205|141707182|SUPERIORITY_OR_OTHER|||||||0.021|||||||Pearson's chi-squared test|||||||0.0210
71099232|NCT01546987|141707234|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.55|TWO_SIDED|95.0|0.47|1.48||One-sided significance level = 0.05|Log Rank||Reference level = ADT + RT|Revised protocol due to early accrual closure (September 2014) computes that seventy events with five years of additional follow-up after early accrual closure provides 70% power (at one-sided alpha = 0.05) to detect a 40% reduction in the assumed rate control arm rate of is 0.08/year.||1.48|0.47|0.55
71099233|NCT01546987|141707235|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.27|TWO_SIDED|95.0|0.38|1.31||Two-sided significance level = 0.05|Log Rank||Reference level = ADT + RT|Revised protocol due to early accrual closure (September 2014) computes that 5-year survival of 78% and annual hazard rate of 0.055 for ADT + RT arm, with five years of additional follow-up after early accrual closure provides 28% power (at two-sided alpha = 0.05) to detect a 33% reduction in failure rate.||1.31|0.38|0.27
71099234|NCT01546987|141707236|SUPERIORITY||Hazard Ratio (HR)|2.29|||<|0.001|TWO_SIDED|95.0|1.54|3.4|||Log Rank||Reference level = ADT + RT arm|||3.40|1.54|<0.001
71099235|NCT01546987|141707237|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.99|TWO_SIDED|95.0|0.33|3.13|||Log Rank|||||3.13|0.33|0.99
71099236|NCT01546987|141707238|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.48|TWO_SIDED|95.0|0.29|1.75||Two-sided significance level = 0.05|Log Rank||Reference level = ADT + RT arm|Revised protocol due to early accrual closure (September 2014) computes that 5-year survival of 78% and annual hazard rate of 0.02 for ADT + RT arm, with five years of additional follow-up after early accrual closure provides 32% power (at two-sided alpha = 0.05) to detect a 50% reduction in failure rate.||1.75|0.29|0.48
71099237|NCT01546987|141707239|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.65|TWO_SIDED|95.0|0.45|1.63||Two-sided significance level = 0.05|Log Rank||Reference level = ADT + RT|||1.63|0.45|0.65
71099238|NCT01546987|141707241|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||One hundred thirty evaluable participants (arms combined), provides 81% power to detect a moderate effect size of 0.5 using a two-sample test of the difference in means with a two-sided type I error of 0.05.||||0.76
71099239|NCT01546987|141707242|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||\[Bowel domain\] One hundred thirty evaluable participants (arms combined), provides 81% power to detect a moderate effect size of 0.5 using a two-sample test of the difference in means with a two-sided type I error of 0.05.||||0.44
70993702|NCT03006471|141496357|SUPERIORITY|||||||0.046||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.046
70993703|NCT03006471|141496358|SUPERIORITY|||||||0.752||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.752
70993704|NCT03006471|141496358|SUPERIORITY|||||||0.582||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.582
70993705|NCT03006471|141496359|SUPERIORITY|||||||0.814||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.814
70993706|NCT03006471|141496359|SUPERIORITY|||||||0.22||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.220
70993707|NCT03006471|141496360|SUPERIORITY|||||||0.624||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.624
71039947|NCT01559116|141587882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.124|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.093|0.154|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.154|0.093|<0.0001
71039948|NCT01559116|141587883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.243|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.212|0.273|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.273|0.212|<0.0001
70993708|NCT03006471|141496360|SUPERIORITY|||||||1||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||1.000
70993709|NCT03006471|141496361|SUPERIORITY|||||||0.906||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.906
70993710|NCT03006471|141496361|SUPERIORITY|||||||0.017||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.017
70993711|NCT03006471|141496362|SUPERIORITY|||||||0.454||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.454
70993712|NCT03006471|141496362|SUPERIORITY|||||||0.115||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.115
70993713|NCT03006471|141496363|SUPERIORITY|||||||0.422||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.422
70993714|NCT03006471|141496363|SUPERIORITY|||||||0.917||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.917
70993715|NCT03006471|141496364|SUPERIORITY|||||||0.65||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.650
70993716|NCT03006471|141496364|SUPERIORITY|||||||0.108||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.108
70993717|NCT03006471|141496365|SUPERIORITY|||||||0.875||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.875
70993718|NCT03006471|141496365|SUPERIORITY|||||||0.196||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of waist circumference in dapagliflozin group||||0.196
71039949|NCT01559116|141587883|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.074|0.133|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.133|0.074|<0.0001
71039950|NCT01559116|141587883|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.072|0.132|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.132|0.072|<0.0001
71099240|NCT01546987|141707242|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||\[Urinary domain\] One hundred thirty evaluable participants (arms combined), provides 81% power to detect a moderate effect size of 0.5 using a two-sample test of the difference in means with a two-sided type I error of 0.05.||||0.13
70993719|NCT03006471|141496366|SUPERIORITY|||||||0.552||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.552
70993720|NCT03006471|141496366|SUPERIORITY|||||||0.087||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.087
70993721|NCT03006471|141496367|SUPERIORITY|||||||0.814||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.814
70993722|NCT03006471|141496367|SUPERIORITY|||||||0.463||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.463
70993723|NCT03006471|141496368|SUPERIORITY|||||||0.53||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.530
70993724|NCT03006471|141496368|SUPERIORITY|||||||0.507||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.507
70993725|NCT03006471|141496369|SUPERIORITY|||||||0.152||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.152
70993726|NCT03006471|141496369|SUPERIORITY|||||||0.972||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.972
70993727|NCT03006471|141496370|SUPERIORITY|||||||0.152||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.152
70993728|NCT03006471|141496370|SUPERIORITY|||||||0.158||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.158
71039951|NCT01559116|141587883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.201|0.262|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.262|0.201|<0.0001
70993729|NCT03006471|141496371|SUPERIORITY|||||||0.944||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.944
70993730|NCT03006471|141496371|SUPERIORITY|||||||0.65||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.650
70993731|NCT03006471|141496372|SUPERIORITY|||||||0.087||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.087
70993732|NCT03006471|141496372|SUPERIORITY|||||||0.345||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.345
70993733|NCT03006471|141496373|SUPERIORITY|||||||0.115||||||The threshold for statistical significance was p=0.05|Chi-squared|||Results showed in this section are the result of the differences between change of intervention group||||0.115
70993734|NCT03006471|141496374|SUPERIORITY|||||||0.047||||||The threshold for statistical significance was p=0.05|Chi-squared|||Results showed in this section are the result of the differences between change of intervention groups||||0.047
70993735|NCT03006471|141496375|SUPERIORITY|||||||0.539||||||The threshold for statistical significance was p=0.05|Chi-squared|||Results showed in this section are the result of the differences between change of intervention groups||||0.539
70993736|NCT03006471|141496376|SUPERIORITY|||||||0.844||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.844
70993737|NCT03006471|141496376|SUPERIORITY|||||||0.01||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.010
71039952|NCT01559116|141587883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.063|0.123|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.123|0.063|<0.0001
71039953|NCT01559116|141587883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.08|0.14|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.140|0.080|<0.0001
70993738|NCT03006471|141496377|SUPERIORITY|||||||0.814||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.814
70993739|NCT03006471|141496377|SUPERIORITY|||||||0.011||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.011
70993740|NCT03006471|141496378|SUPERIORITY|||||||0.221||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.221
70993741|NCT03006471|141496378|SUPERIORITY|||||||0.001||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.001
70993742|NCT03006471|141496379|SUPERIORITY|||||||0.461||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.461
71039954|NCT01559116|141587883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.061|0.121|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.121|0.061|<0.0001
71039955|NCT01559116|141587884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.173|0.241|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.241|0.173|<0.0001
71099241|NCT01546987|141707242|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||\[Sexual domain\] One hundred thirty evaluable participants (arms combined), provides 81% power to detect a moderate effect size of 0.5 using a two-sample test of the difference in means with a two-sided type I error of 0.05.||||0.50
70993743|NCT03006471|141496379|SUPERIORITY|||||||0.011||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.011
70993744|NCT03006471|141496380|SUPERIORITY|||||||0.285||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.285
70993745|NCT03006471|141496380|SUPERIORITY|||||||0.002||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.002
70993746|NCT03006471|141496381|SUPERIORITY|||||||0.701||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.701
70993747|NCT03006471|141496381|SUPERIORITY|||||||0.081||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.081
70993748|NCT03006471|141496382|SUPERIORITY|||||||0.581||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.581
71039956|NCT01559116|141587884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.059|0.126|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.126|0.059|<0.0001
71039957|NCT01559116|141587884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.045|0.113|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.113|0.045|<0.0001
71039958|NCT01559116|141587884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.201|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.167|0.235|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.235|0.167|<0.0001
71039959|NCT01559116|141587884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.052|0.12|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.120|0.052|<0.0001
71039960|NCT01559116|141587884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.067|0.135|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.135|0.067|<0.0001
71039961|NCT01559116|141587884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.039|0.107|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.107|0.039|<0.0001
70993749|NCT03006471|141496382|SUPERIORITY|||||||0.004||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of HDL-cholesterol on dapagliflozin group||||0.004
71039962|NCT01559116|141587885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.338|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.305|0.371|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.371|0.305|<0.0001
70993750|NCT03006471|141496383|SUPERIORITY|||||||0.727||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.727
70993751|NCT03006471|141496383|SUPERIORITY|||||||0.451||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.451
71039963|NCT01559116|141587885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.087|0.153|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.153|0.087|<0.0001
71099242|NCT01546987|141707242|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||\[Hormonal domain\] One hundred thirty evaluable participants (arms combined), provides 81% power to detect a moderate effect size of 0.5 using a two-sample test of the difference in means with a two-sided type I error of 0.05.||||0.96
71099243|NCT01546987|141707253|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.0104|TWO_SIDED|95.0|0.29|0.89|||Log Rank||Reference arm = ADT + RT arm|||0.89|0.29|0.0104
71099244|NCT02197065|141707255|OTHER||Proportion|0.2|||||ONE_SIDED|||||||||This was a pilot feasibility study and we were only powered to determine the frequency of troponin elevation in the entire study population, not to compare the frequency of a rise in troponin in the two study arms. Thus Aim 1 applies to the entire study cohort.||||
71099245|NCT02197065|141707256|SUPERIORITY||Median Difference (Final Values)|13.0||||0.58|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.58
71099246|NCT02197065|141707257|SUPERIORITY||Median Difference (Final Values)|0.3||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.00
70993752|NCT03006471|141496384|SUPERIORITY|||||||0.463||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.463
70993753|NCT03006471|141496384|SUPERIORITY|||||||0.043||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.043
70993754|NCT03006471|141496385|SUPERIORITY|||||||0.807||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.807
70993755|NCT03006471|141496385|SUPERIORITY|||||||0.754||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.754
70993756|NCT03006471|141496386|SUPERIORITY|||||||0.507||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.507
70993757|NCT03006471|141496386|SUPERIORITY|||||||0.015||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.015
70993758|NCT03006471|141496387|SUPERIORITY|||||||0.039||||||The threshold for statistical significance was p=0.05|Fisher Exact|||Results showed in this section are the result of the differences between intervention groups||||0.039
70993759|NCT03006471|141496388|SUPERIORITY|||||||0.011|||||||Fisher Exact|||Results showed in this section are the result of the differences between intervention groups||||0.011
70993760|NCT03006471|141496389|SUPERIORITY|||||||0.096||||||The threshold for statistical significance was p=0.05|Fisher Exact|||Results showed in this section are the result of the differences between intervention groups||||0.096
70993761|NCT02581865|141496395|SUPERIORITY||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|1.8||0.4326|TWO_SIDED|95.0|-4.9|2.1|||Mixed Models Analysis|||||2.1|-4.9|0.4326
70993762|NCT02581865|141496395|SUPERIORITY||Mean Difference (Net)|-2.5|STANDARD_ERROR_OF_MEAN|1.9||0.1835|TWO_SIDED|95.0|-6.2|1.2|||Mixed Models Analysis|||||1.2|-6.2|0.1835
70993763|NCT02581865|141496396|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3812|TWO_SIDED|95.0|-0.7|0.3|||ANOVA|||||0.3|-0.7|0.3812
70993764|NCT02581865|141496396|SUPERIORITY||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0146|TWO_SIDED|95.0|-1.2|-0.1|||ANOVA|||||-0.1|-1.2|0.0146
70993765|NCT02581865|141496397|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3065|TWO_SIDED|95.0|-0.6|0.2|||Mixed Models Analysis|||||0.2|-0.6|0.3065
70993766|NCT02581865|141496397|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.2052|TWO_SIDED|95.0|-0.7|0.2|||Mixed Models Analysis|||||0.2|-0.7|0.2052
70993767|NCT02581865|141496398|SUPERIORITY||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|0.8||0.2215|TWO_SIDED|95.0|-2.7|0.6|||ANCOVA|||||0.6|-2.7|0.2215
70993768|NCT02581865|141496398|SUPERIORITY||Mean Difference (Net)|-1.6|STANDARD_ERROR_OF_MEAN|0.9||0.0566|TWO_SIDED|95.0|-3.3|0.0|||ANCOVA|||||0.0|-3.3|0.0566
71039964|NCT01559116|141587885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.078|0.143|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.143|0.078|<0.0001
70993769|NCT02581865|141496399|SUPERIORITY||Mean Difference (Net)|-2.2|STANDARD_ERROR_OF_MEAN|3.8||0.5689|TWO_SIDED|95.0|-9.8|5.4|||Mixed Models Analysis|||||5.4|-9.8|0.5689
70993770|NCT02581865|141496399|SUPERIORITY||Mean Difference (Net)|-4.8|STANDARD_ERROR_OF_MEAN|4.0||0.232|TWO_SIDED|95.0|-12.8|3.1|||Mixed Models Analysis|||||3.1|-12.8|0.2320
70993771|NCT02581865|141496400|SUPERIORITY||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|1.1||0.4515|TWO_SIDED|95.0|-3.0|1.3|||Mixed Models Analysis|||||1.3|-3.0|0.4515
70993772|NCT02581865|141496400|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|1.1||0.6289|TWO_SIDED|95.0|-2.8|1.7|||Mixed Models Analysis|||||1.7|-2.8|0.6289
70993773|NCT03224585|141496407|SUPERIORITY|||||||0.0121|||||||Paired samples Wilcoxon test|||This analysis compared the change in pain scores between baseline and 6 hours||||0.0121
70993774|NCT03224585|141496408|SUPERIORITY|||||||0.0025|||||||Paired samples Wilcoxon test|||||||0.0025
70993775|NCT01175213|141496409|SUPERIORITY_OR_OTHER_LEGACY||Poisson|0.02|||<|0.0001|ONE_SIDED|99.0||0.045||Testing the null hypothesis of 1 VASBI/year against a one-sided alternative at the 0.01 level of statistical significance.|Poisson|||||0.045||<0.0001
70993776|NCT01921634|141496439|SUPERIORITY||Odds Ratio (OR)|1.3||||0.01|TWO_SIDED|95.0|1.1|1.7|||McNemar||The odds ratio was generated from a logistic regression model using generalized estimating equations with a logit link and represents a comparison of modified (numerator) vs standard (denominator).|||1.7|1.1|0.01
70993777|NCT00781963|141496477|SUPERIORITY||Mean Difference (Final Values)|-15.8|STANDARD_ERROR_OF_MEAN|6.6|<|0.001|TWO_SIDED|95.0|-28.7|-3.0|||Mixed Models Analysis||The parameter estimate is the improvement in sleep onset latency from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.|||-3.0|-28.7|<.001
70993778|NCT00781963|141496478|SUPERIORITY||Mean Difference (Final Values)|-10.2|STANDARD_ERROR_OF_MEAN|8.2||0.21|TWO_SIDED|95.0|-26.3|5.9|||Mixed Models Analysis||The parameter estimate is the improvement in wake after sleep onset from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.|||5.9|-26.3|0.21
71039965|NCT01559116|141587885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.317|0.383|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.383|0.317|<0.0001
71039966|NCT01559116|141587885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.098|0.164|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.164|0.098|<0.0001
71039967|NCT01559116|141587885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.099|0.165|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.165|0.099|<0.0001
71039968|NCT01559116|141587885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.122|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.089|0.155|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.155|0.089|<0.0001
70993779|NCT00781963|141496479|SUPERIORITY||Mean Difference (Final Values)|-37.0|STANDARD_ERROR_OF_MEAN|12.9||0.004|TWO_SIDED|95.0|-62.2|-11.7|||Mixed Models Analysis||The parameter estimate is the improvement in total wake time from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.|||-11.7|-62.2|0.004
70993780|NCT00781963|141496480|SUPERIORITY||Mean Difference (Final Values)|6.7|STANDARD_ERROR_OF_MEAN|2.36||0.005|TWO_SIDED|95.0|2.0|11.3|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.|||11.3|2.0|.005
70993781|NCT00781963|141496481|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.97||0.15|TWO_SIDED|95.0|-3.3|0.5|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency (from wrist actigraphy) from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.|||0.5|-3.3|0.15
71039969|NCT01559116|141587886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.433|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.389|0.477|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.477|0.389|<0.0001
71039970|NCT01559116|141587886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.166|0.253|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.253|0.166|<0.0001
71039971|NCT01559116|141587886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.177|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.133|0.221|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.221|0.133|<0.0001
71039972|NCT01559116|141587886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.396|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.352|0.441|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.441|0.352|<0.0001
71039973|NCT01559116|141587886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.129|0.217|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.217|0.129|<0.0001
71039974|NCT01559116|141587886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.115|0.203|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated. is calculated.|||0.203|0.115|<0.0001
71039975|NCT01559116|141587886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.096|0.184|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.184|0.096|<0.0001
71039976|NCT01559116|141587887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.463|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.417|0.509|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to placebo is calculated.|||0.509|0.417|<0.0001
71039977|NCT01559116|141587887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.154|0.246|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.246|0.154|<0.0001
71039978|NCT01559116|141587887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.179|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.133|0.225|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.225|0.133|<0.0001
71039979|NCT01559116|141587887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.443|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.396|0.49|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.490|0.396|<0.0001
71039980|NCT01559116|141587887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.181|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.134|0.227|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.227|0.134|<0.0001
71039981|NCT01559116|141587887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.125|0.218|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.218|0.125|<0.0001
71039982|NCT01559116|141587887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.113|0.206|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.206|0.113|<0.0001
71039983|NCT01559116|141587888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.404|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.355|0.453|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.453|0.355|<0.0001
70993782|NCT00781963|141496482|SUPERIORITY||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|-3.5|-1.3|||Mixed Models Analysis||The parameter estimate is the improvement in PSQI score from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.|||-1.3|-3.5|<.001
70993783|NCT00680953|141496483|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.343||||0.0001|TWO_SIDED|95.0|0.194|0.606|||Log Rank|||||0.606|0.194|0.0001
70993784|NCT00680953|141496484|SUPERIORITY_OR_OTHER|||||||0.9951|||||||Log Rank|||||||0.9951
70993785|NCT00680953|141496485|SUPERIORITY_OR_OTHER|||||||0.1568|||||||Log Rank|||||||0.1568
71039984|NCT01559116|141587888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.219|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.17|0.267|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.267|0.170|<0.0001
70993786|NCT03057951|141496486|SUPERIORITY|H0: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.79||||0.0003|TWO_SIDED|95.03|0.69|0.9|||Regression, Cox||Comparison vs. Placebo \[T/P\]|"Cox regression, with terms for treatment, region, baseline status of diabetes, age, sex, left ventricular ejection fraction (LVEF) and glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr) at baseline.~alpha=0.0497 (resulting from interim analysis)."||0.90|0.69|0.0003
70993787|NCT03057951|141496487|SUPERIORITY|H0: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.73||||0.0009|TWO_SIDED|95.03|0.61|0.88|||Joint frailty model||Comparison vs. Placebo \[T/P\]|Joint frailty model that accounts for dependence between recurrent HHF and cardiovascular death, with terms for age, baseline eGFR (CKD-EPK)cr, baseline LVEF, region, baseline diabetes status, sex, and treatment. eGFR (CKP-EPI)cr: Glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement LVEF: Left ventricular ejection fraction. alpha=0.0497 (resulting from interim analysis).||0.88|0.61|0.0009
70993788|NCT03057951|141496488|SUPERIORITY|H0: There is no difference between the effect of placebo and the effect of empagliflozin.|Treatment by time interaction|1.363|||<|0.0001|TWO_SIDED|99.9|0.861|1.865|||Random intercept random coeff. model||Empa 10 mg vs. Placebo slope \[/year\]|"Random coefficient model allowing for random intercept and random slope per patient, with factors age, baseline eGFR (CKD-EPI), baseline LVEF as linear covariate(s) and region, baseline diabetes status, sex, baseline-by-time interaction, treatment-by-time interaction and treatment as fixed effects.~Only 'on-treatment' data from treated patients were used. alpha=0.001. covariance structure: Unstructured."||1.865|0.861|<0.0001
70993789|NCT03057951|141496489|OTHER||Hazard Ratio (HR)|0.95||||0.7243|TWO_SIDED|95.0|0.73|1.24|||Regression, Cox||Comparison vs Placebo \[T/P\]|Cox regression model included terms age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr), region, baseline diabetes status, sex, baseline Left ventricular ejection fraction (LVEF) and treatment.||1.24|0.73|0.7243
70993790|NCT03057951|141496490|OTHER||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.6|0.83|||Regression, Cox||Comparison vs. Placebo \[T/P\]|Cox regression model included terms age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr), region, baseline diabetes status, sex, baseline Left ventricular ejection fraction (LVEF) and treatment.||0.83|0.60|<0.0001
70993791|NCT03057951|141496491|OTHER||Hazard Ratio (HR)|0.91||||0.2951|TWO_SIDED|95.0|0.76|1.09|||Regression, Cox||Comparison vs. Placebo \[T/P\]|Cox regression model included terms age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr), region, baseline diabetes status, sex, baseline Left ventricular ejection fraction (LVEF) and treatment.||1.09|0.76|0.2951
70993792|NCT03057951|141496492|OTHER||Hazard Ratio (HR)|1.0||||0.9893|TWO_SIDED|95.0|0.87|1.15|||Regression, Cox||Comparison vs. Placebo \[T/P\]|Cox regression model included terms age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr), region, baseline diabetes status, sex, baseline Left ventricular ejection fraction (LVEF) and treatment.||1.15|0.87|0.9893
70993793|NCT03057951|141496493|OTHER||Hazard Ratio (HR)|0.84||||0.1539|TWO_SIDED|95.0|0.65|1.07|||Regression, Cox||Comparison vs. Placebo \[T/P\]|Cox regression model included terms age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr), region, baseline diabetes status, sex, baseline Left ventricular ejection fraction (LVEF) and treatment.||1.07|0.65|0.1539
70993794|NCT03057951|141496494|OTHER||Adjusted mean difference|1.32|STANDARD_ERROR_OF_MEAN|0.44||0.0028|TWO_SIDED|95.0|0.45|2.19|||Mixed Model Repeated Measures (MMRM)||Comparison vs Placebo \[T-P\]|"Model includes age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula (eGFR (CKD-EPI)), baseline Left ventricular ejection fraction (LVEF) as linear covariate(s) and region, baseline diabetes status, sex, week reachable, treatment-by-visit interaction, baseline KCCQ-Clinical-Summary-Score-by-visit interaction as fixed effect(s).~Unstructured covariance structure."||2.19|0.45|0.0028
71039985|NCT01559116|141587888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.126|0.223|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.223|0.126|<0.0001
71039986|NCT01559116|141587888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.351|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.301|0.4|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.400|0.301|<0.0001
71099247|NCT00452530|141707271|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5||||0.0003||||||1-sided P-value|Yanagawa, Tango, and Hiejima test||Apixaban-enoxaparin|Sequential testing was used to control for overall type-I error and to compare the effect of apixaban with that of enoxaparin. Noninferiority (NI) of apixaban compared with enoxaparin for primary endpoint was tested first at 1-sided α=0.025 level. If superiority was demonstrated on the primary endpoint, NI was then tested on the secondary endpoint at a 1-sided α=0.025 level. If NI of the secondary endpoint was demonstrated, superiority was then tested at the 1-sided α=0.025 level.||||0.0003
71099248|NCT00452530|141707271|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.04||||||95.0|-2.03|-0.05|||Inverse variance method|||Sequential testing was used to control for overall type-I error and to compare the effect of apixaban with that of enoxaparin. Noninferiority (NI) of apixaban compared with enoxaparin for primary endpoint was tested first at 1-sided α=0.025 level. If superiority was demonstrated on the primary endpoint, NI was then tested on the secondary endpoint at a 1-sided α=0.025 level. If NI of the secondary endpoint was demonstrated, superiority was then tested at the 1-sided α=0.025 level.||-0.05|-2.03|
70993795|NCT03057951|141496495|OTHER||Hazard Ratio (HR)|0.93||||0.1012|TWO_SIDED|95.0|0.85|1.01|||Joint frailty model||Comparison vs. Placebo \[T/P\]|Joint frailty model that accounts for the dependence between recurrent all-cause hospitalisation and all-cause mortality was used. Joint frailty model with terms for age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula (eGFR (CKD-EPI)), baseline Left ventricular ejection fraction (LVEF), treatment, region, baseline diabetes status and sex.||1.01|0.85|0.1012
70993796|NCT02064205|141496496|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.0|STANDARD_DEVIATION|1000.0||0.2918|ONE_SIDED||||||Mixed Models Analysis|||A mixed model was applied to analyze the Energy Intakes (ad libitum lunch and daily) were done one-sided to evaluate the appetite suppressive effect after the pre-load snack (condition C versus D)||||0.2918
70993797|NCT02064205|141496497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0109|||||||Mixed Models Analysis|||AUC of hunger scores before preload intake for condition C versus D.||||0.0109
71099249|NCT00452530|141707272|SUPERIORITY_OR_OTHER||Adjusted difference of event rates|-0.33||||0.3014|TWO_SIDED|95.0|-0.95|0.29|||Mantel Haenszel||Apixaban-enoxaparin|Major bleeding||0.29|-0.95|0.3014
71099250|NCT00452530|141707272|SUPERIORITY_OR_OTHER||Adjusted difference of event rates|-0.91||||0.1668|TWO_SIDED|95.0|-2.2|0.38|||Mantel Haenszel||Apixaban-enoxaparin|CRNM||0.38|-2.20|0.1668
71099251|NCT00452530|141707272|SUPERIORITY_OR_OTHER||Adjusted difference of event rates|-1.24||||0.0881|TWO_SIDED|95.0|-2.66|0.18|||Mantel Haenszel||Apixaban-enoxaparin|Major or CRNM||0.18|-2.66|0.0881
71099252|NCT00452530|141707272|SUPERIORITY_OR_OTHER||Adjusted difference of event rates|-1.39||||0.1412|TWO_SIDED|95.0|-3.29|0.51|||Mantel Haenszel||Apixaban-enoxaparin|Any bleeding||0.51|-3.29|0.1412
71099253|NCT00452530|141707273|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.51|0.74||P-value was statistically significant at the 1-sided 0.025 level|Yanagawa, Tango, and Hiejima test||Apixaban-enoxaparin|Sequential testing was used to control for overall type-I error and to compare the effect of apixaban with that of enoxaparin. Noninferiority (NI) of apixaban compared with enoxaparin for primary endpoint was tested first at 1-sided α=0.025 level. If NI on primary endpoint was demonstrated, superiority for the endpoint was then tested at 1-sided α=0.025 level. If superiority was demonstrated on the primary endpoint, NI was then tested on the key secondary endpoint at 1-sided α=0.025 level.||0.74|0.51|<0.0001
71099254|NCT00452530|141707273|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-9.27|||<|0.0001||95.0|-12.74|-5.79||P-value is statistically significant at the 1-sided 0.025 level|Yanagawa, Tango, and Hiejima test||Apixaban-enoxaparin|Sequential testing was used to control for overall type-I error and to compare the effect of apixaban with that of enoxaparin. Noninferiority (NI) of apixaban compared with enoxaparin for primary endpoint was tested first at 1-sided α=0.025 level. If NI on primary endpoint was demonstrated, superiority for the endpoint was then tested at 1-sided α=0.025 level. If superiority was demonstrated on the primary endpoint, NI was then tested on the key secondary endpoint at 1-sided α=0.025 level.||-5.79|-12.74|<0.0001
70993798|NCT02064205|141496498|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0216||||||GLP-1|Mixed Models Analysis|||A mixed model was applied to statistically analyze satiety hormones having Conditions and Time as a fixed factor and having Subject, Cohort, and Treatment Day as random factors.||||0.0216
70993799|NCT00696436|141496499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.27|||<|0.001|TWO_SIDED|95.0|-16.54|-12.01||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-12.01|-16.54|<0.001
70993800|NCT00696436|141496499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.16|||<|0.001|TWO_SIDED|95.0|-15.41|-10.91||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-10.91|-15.41|<0.001
70993801|NCT00696436|141496499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.54||||0.009|TWO_SIDED|95.0|-4.44|-0.64||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-0.64|-4.44|0.009
70993802|NCT00696436|141496499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.31|||<|0.001|TWO_SIDED|95.0|-6.25|-2.37||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-2.37|-6.25|<0.001
70993803|NCT00696436|141496499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.43||||0.136|TWO_SIDED|95.0|-3.31|0.45||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||0.45|-3.31|0.136
70993804|NCT00696436|141496499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2||||0.001|TWO_SIDED|95.0|-5.12|-1.27||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-1.27|-5.12|0.001
70993805|NCT00696436|141496500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.92|||<|0.001|TWO_SIDED|95.0|-18.07|-11.76||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-11.76|-18.07|<0.001
70993806|NCT00696436|141496500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.55|||<|0.001|TWO_SIDED|95.0|-17.71|-11.4||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-11.40|-17.71|<0.001
70993807|NCT00696436|141496500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.54||||0.008|TWO_SIDED|95.0|-6.17|-0.92||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-0.92|-6.17|0.008
70993808|NCT00696436|141496500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.43|||<|0.001|TWO_SIDED|95.0|-8.09|-2.78||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-2.78|-8.09|<0.001
70993809|NCT00696436|141496500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.18||||0.018|TWO_SIDED|95.0|-5.81|-0.55||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-0.55|-5.81|0.018
70993810|NCT00696436|141496500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.07|||<|0.001|TWO_SIDED|95.0|-7.73|-2.42||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-2.42|-7.73|<0.001
70993811|NCT00696436|141496501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.36|||<|0.001|TWO_SIDED|95.0|-10.91|-7.81||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-7.81|-10.91|<0.001
70993812|NCT00696436|141496501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.58|||<|0.001|TWO_SIDED|95.0|-10.12|-7.04||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-7.04|-10.12|<0.001
70993813|NCT00696436|141496501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.011|TWO_SIDED|95.0|-2.99|-0.4||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.40|-2.99|0.011
70993814|NCT00696436|141496501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35|||<|0.001|TWO_SIDED|95.0|-3.67|-1.02||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.02|-3.67|<0.001
71039987|NCT01559116|141587888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.117|0.214|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.214|0.117|<0.0001
71039988|NCT01559116|141587888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.099|0.197|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.197|0.099|<0.0001
71039989|NCT01559116|141587888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.072|0.17|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.170|0.072|<0.0001
70993815|NCT00696436|141496501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91||||0.166|TWO_SIDED|95.0|-2.19|0.38||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.38|-2.19|0.166
70993816|NCT00696436|141496501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.56||||0.02|TWO_SIDED|95.0|-2.88|-0.24||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.24|-2.88|0.020
71039990|NCT01559116|141587889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.329|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.274|0.385|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.385|0.274|<0.0001
71039991|NCT01559116|141587889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.115|0.225|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.225|0.115|<0.0001
71039992|NCT01559116|141587889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.066|0.176|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.176|0.066|<0.0001
71039993|NCT01559116|141587889|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.307|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001|TWO_SIDED|95.0|0.251|0.363|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.363|0.251|<0.0001
71039994|NCT01559116|141587889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.092|0.203|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.203|0.092|<0.0001
71039995|NCT01559116|141587889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.111|0.222|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.222|0.111|<0.0001
71039996|NCT01559116|141587889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.043|0.154|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.154|0.043|<0.0001
71039997|NCT01559116|141587890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.462|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.408|0.516|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.516|0.408|<0.0001
71039998|NCT01559116|141587890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.105|0.212|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.212|0.105|<0.0001
70993817|NCT00696436|141496502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.51|||<|0.001|TWO_SIDED|95.0|-9.33|-5.69||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-5.69|-9.33|<0.001
70993818|NCT00696436|141496502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.21|||<|0.001|TWO_SIDED|95.0|-8.03|-4.39||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-4.39|-8.03|<0.001
70993819|NCT00696436|141496502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.18||||0.005|TWO_SIDED|95.0|-3.69|-0.67||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.67|-3.69|0.005
70993820|NCT00696436|141496502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.17|||<|0.001|TWO_SIDED|95.0|-4.69|-1.64||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.64|-4.69|<0.001
70993821|NCT00696436|141496502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87||||0.257|TWO_SIDED|95.0|-2.39|0.64||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.64|-2.39|0.257
70993822|NCT00696436|141496502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.86||||0.017|TWO_SIDED|95.0|-3.39|-0.33||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.33|-3.39|0.017
70993823|NCT00696436|141496503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.92|||<|0.001|TWO_SIDED|95.0|-17.3|-12.54||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-12.54|-17.30|<0.001
70993824|NCT00696436|141496503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.63|||<|0.001|TWO_SIDED|95.0|-15.99|-11.27||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-11.27|-15.99|<0.001
70993825|NCT00696436|141496503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.86||||0.005|TWO_SIDED|95.0|-4.85|-0.87||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.87|-4.85|0.005
70993826|NCT00696436|141496503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.76|||<|0.001|TWO_SIDED|95.0|-6.8|-2.73||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-2.73|-6.80|<0.001
70993827|NCT00696436|141496503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.57||||0.119|TWO_SIDED|95.0|-3.55|0.4||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.40|-3.55|0.119
70993828|NCT00696436|141496503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47|||<|0.001|TWO_SIDED|95.0|-5.49|-1.45||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.45|-5.49|<0.001
70993829|NCT00696436|141496504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.81|||<|0.001|TWO_SIDED|95.0|-11.48|-8.13||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-8.13|-11.48|<0.001
70993830|NCT00696436|141496504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.96|||<|0.001|TWO_SIDED|95.0|-10.63|-7.3||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-7.30|-10.63|<0.001
70993831|NCT00696436|141496504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99||||0.006|TWO_SIDED|95.0|-3.39|-0.58||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.58|-3.39|0.006
70993832|NCT00696436|141496504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.57|||<|0.001|TWO_SIDED|95.0|-4.0|-1.14||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.14|-4.00|<0.001
70993833|NCT00696436|141496504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14||||0.107|TWO_SIDED|95.0|-2.53|0.25||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.25|-2.53|0.107
70993834|NCT00696436|141496504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.73||||0.017|TWO_SIDED|95.0|-3.15|-0.3||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.30|-3.15|0.017
70993835|NCT00696436|141496505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.0|||<|0.001|TWO_SIDED|95.0|-15.56|-10.45||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-10.45|-15.56|<0.001
70993836|NCT00696436|141496505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.97|||<|0.001|TWO_SIDED|95.0|-14.51|-9.43||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-9.43|-14.51|<0.001
70993837|NCT00696436|141496505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.42||||0.194|TWO_SIDED|95.0|-3.56|0.72||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.72|-3.56|0.194
70993838|NCT00696436|141496505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.65||||0.001|TWO_SIDED|95.0|-5.84|-1.46||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.46|-5.84|0.001
70993839|NCT00696436|141496505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.72|TWO_SIDED|95.0|-2.51|1.73||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||1.73|-2.51|0.720
70993840|NCT00696436|141496505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.62||||0.018|TWO_SIDED|95.0|-4.79|-0.45||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.45|-4.79|0.018
70993841|NCT00696436|141496506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.64|||<|0.001|TWO_SIDED|95.0|-10.42|-6.87||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-6.87|-10.42|<0.001
70993842|NCT00696436|141496506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.75|||<|0.001|TWO_SIDED|95.0|-9.52|-5.99||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-5.99|-9.52|<0.001
70993843|NCT00696436|141496506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72||||0.341|TWO_SIDED|95.0|-2.21|0.77||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.77|-2.21|0.341
70993844|NCT00696436|141496506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.28||||0.003|TWO_SIDED|95.0|-3.8|-0.76||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.76|-3.80|0.003
70993845|NCT00696436|141496506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.821|TWO_SIDED|95.0|-1.3|1.64||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||1.64|-1.30|0.821
70993846|NCT00696436|141496506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39||||0.071|TWO_SIDED|95.0|-2.89|0.12||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.12|-2.89|0.071
70993847|NCT00696436|141496507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.45|||<|0.001|TWO_SIDED|95.0|-17.96|-12.94||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-12.94|-17.96|<0.001
70993848|NCT00696436|141496507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.93|||<|0.001|TWO_SIDED|95.0|-16.42|-11.43||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-11.43|-16.42|<0.001
70993849|NCT00696436|141496507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.32||||0.002|TWO_SIDED|95.0|-5.42|-1.22||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.22|-5.42|0.002
70993850|NCT00696436|141496507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.11|||<|0.001|TWO_SIDED|95.0|-7.26|-2.97||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-2.97|-7.26|<0.001
70993851|NCT00696436|141496507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.091|TWO_SIDED|95.0|-3.88|0.29||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.29|-3.88|0.091
70993852|NCT00696436|141496507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.59|||<|0.001|TWO_SIDED|95.0|-5.72|-1.46||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.46|-5.72|<0.001
70993853|NCT00696436|141496508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.14|||<|0.001|TWO_SIDED|95.0|-11.92|-8.36||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-8.36|-11.92|<0.001
70993854|NCT00696436|141496508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.17|||<|0.001|TWO_SIDED|95.0|-10.94|-7.4||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-7.40|-10.94|<0.001
70993855|NCT00696436|141496508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.31||||0.002|TWO_SIDED|95.0|-3.81|-0.82||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.82|-3.81|0.002
70993856|NCT00696436|141496508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.71|||<|0.001|TWO_SIDED|95.0|-4.24|-1.19||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.19|-4.24|<0.001
70993857|NCT00696436|141496508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.076|TWO_SIDED|95.0|-2.82|0.14||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.14|-2.82|0.076
70993858|NCT00696436|141496508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.74||||0.024|TWO_SIDED|95.0|-3.25|-0.22||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.22|-3.25|0.024
70993859|NCT00696436|141496509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.84|||<|0.001|TWO_SIDED|95.0|-15.66|-10.02||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-10.02|-15.66|<0.001
70993860|NCT00696436|141496509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.91|||<|0.001|TWO_SIDED|95.0|-14.72|-9.11||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-9.11|-14.72|<0.001
70993861|NCT00696436|141496509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.74||||0.149|TWO_SIDED|95.0|-4.1|0.62||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.62|-4.10|0.149
70993862|NCT00696436|141496509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.24|||<|0.001|TWO_SIDED|95.0|-6.65|-1.83||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.83|-6.65|<0.001
70993863|NCT00696436|141496509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.494|TWO_SIDED|95.0|-3.16|1.53||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||1.53|-3.16|0.494
70993864|NCT00696436|141496509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.32||||0.007|TWO_SIDED|95.0|-5.72|-0.93||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.93|-5.72|0.007
70993865|NCT00696436|141496510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.91|||<|0.001|TWO_SIDED|95.0|-10.03|-5.79||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-5.79|-10.03|<0.001
71039999|NCT01559116|141587890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.098|0.205|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.205|0.098|<0.0001
71040000|NCT01559116|141587890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.452|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.398|0.507|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.507|0.398|<0.0001
71040001|NCT01559116|141587890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.149|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.095|0.203|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.203|0.095|<0.0001
71040002|NCT01559116|141587890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.107|0.216|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.216|0.107|<0.0001
71099255|NCT02191397|141707278|NON_INFERIORITY|A one-sided 97.5% confidence interval for the between-treatment difference (bupropion XL-escitalopram) was compared with the pre-defined non-inferiority margin of 2.2. If the upper limit of the one-sided 97.5% confidence interval was below 2.2, then it indicated that bupropion was not inferior in efficacy to escitalopram.|Mean Difference (Final Values)|0.8||||0.139|TWO_SIDED|95.0|-0.27|1.94||Analysis included Baseline HAMD-17 total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Observed Cases (OC) dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||1.94|-0.27|0.139
70993866|NCT00696436|141496510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.99|||<|0.001|TWO_SIDED|95.0|-10.1|-5.88||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-5.88|-10.10|<0.001
70993867|NCT00696436|141496510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.691|TWO_SIDED|95.0|-2.14|1.42||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||1.42|-2.14|0.691
70993868|NCT00696436|141496510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.39||||0.01|TWO_SIDED|95.0|-4.2|-0.57||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.57|-4.20|0.010
71040003|NCT01559116|141587890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.087|0.196|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.196|0.087|<0.0001
71099256|NCT02191397|141707279|OTHER||Odds Ratio (OR)|0.85||||0.479|TWO_SIDED|95.0|0.55|1.33||P-value was estimated from a Generalized Estimating Equation (GEE) model with Response based on HADM-17 as response variable and treatment, gender as explanatory variables.|GEE model|||||1.33|0.55|0.479
71099257|NCT02191397|141707280|OTHER||Odds Ratio (OR)|0.73||||0.129|TWO_SIDED|95.0|0.48|1.1||P-value was estimated from a Generalized Estimating Equation (GEE) model with Response based on HADM-17 as response variable and treatment, gender as explanatory variables|GEE model|||||1.10|0.48|0.129
71099258|NCT02191397|141707281|OTHER||Odds Ratio (OR)|0.83||||0.354|TWO_SIDED|95.0|0.55|1.24||P-value was estimated from a GEE model with Response based on HADM-17 as response variable and treatment, gender as explanatory variables|GEE model|||||1.24|0.55|0.354
70993869|NCT00696436|141496510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.625|TWO_SIDED|95.0|-2.2|1.32||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||1.32|-2.20|0.625
70993870|NCT00696436|141496510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.46||||0.008|TWO_SIDED|95.0|-4.27|-0.66||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.66|-4.27|0.008
70993871|NCT00696436|141496511|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.98|||<|0.001|TWO_SIDED|95.0|3.15|7.88||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||7.88|3.15|<0.001
70993872|NCT00696436|141496511|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.66|||<|0.001|TWO_SIDED|95.0|2.94|7.37||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||7.37|2.94|<0.001
70993873|NCT00696436|141496511|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.032|TWO_SIDED|95.0|1.03|2.03||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||2.03|1.03|0.032
70993874|NCT00696436|141496511|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.029|TWO_SIDED|95.0|1.04|2.06||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||2.06|1.04|0.029
70993875|NCT00696436|141496511|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.08|TWO_SIDED|95.0|0.96|1.89||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.89|0.96|0.080
70993876|NCT00696436|141496511|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.071|TWO_SIDED|95.0|0.97|1.92||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.92|0.97|0.071
71099259|NCT02191397|141707282|OTHER||Odds Ratio (OR)|0.85||||0.489|TWO_SIDED|95.0|0.54|1.34||P-value was estimated from a GEE model with Response based on HADM-17 as response variable and treatment, gender as explanatory variables|GEE model|||||1.34|0.54|0.489
70993877|NCT00696436|141496512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.29|||<|0.001|TWO_SIDED|95.0|2.1|5.15||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||5.15|2.10|<0.001
70993878|NCT00696436|141496512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.91|||<|0.001|TWO_SIDED|95.0|1.86|4.54||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||4.54|1.86|<0.001
70993879|NCT00696436|141496512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.306|TWO_SIDED|95.0|0.83|1.8||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.80|0.83|0.306
70993880|NCT00696436|141496512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.132|TWO_SIDED|95.0|0.92|1.97||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.97|0.92|0.132
70993881|NCT00696436|141496512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.695|TWO_SIDED|95.0|0.74|1.58||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.58|0.74|0.695
70993882|NCT00696436|141496512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.381|TWO_SIDED|95.0|0.81|1.74||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.74|0.81|0.381
70993883|NCT00696436|141496513|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.18|||<|0.001|TWO_SIDED|95.0|3.2|8.41||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||8.41|3.20|<0.001
70993884|NCT00696436|141496513|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.43|||<|0.001|TWO_SIDED|95.0|2.73|7.19||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||7.19|2.73|<0.001
70993885|NCT00696436|141496513|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.056|TWO_SIDED|95.0|0.99|1.94||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.94|0.99|0.056
70993886|NCT00696436|141496513|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.036|TWO_SIDED|95.0|1.02|2.02||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||2.02|1.02|0.036
70993887|NCT00696436|141496513|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.317|TWO_SIDED|95.0|0.85|1.66||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.66|0.85|0.317
70993888|NCT00696436|141496513|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.234|TWO_SIDED|95.0|0.87|1.73||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.73|0.87|0.234
70993889|NCT02062463|141496526|OTHER||Odds Ratio (OR)|3.77|||<|0.001|TWO_SIDED|95.0|2.05|6.95||Threshold for significance at 0.05 level.|Chi-squared|||Analysis was performed using a conditional logistic regression model.||6.95|2.05|<0.001
70993890|NCT02062463|141496527|OTHER||Odds Ratio (OR)|1.26||||0.316|TWO_SIDED|95.0|0.8|1.98||Threshold for significance at 0.05 level.|Chi-squared|||Analysis was performed using a conditional logistic regression model.||1.98|0.80|0.316
70993891|NCT03353753|141496548|SUPERIORITY||Hazard Ratio, log|0.15|||<|0.0001|TWO_SIDED|95.0|0.09|0.25||Two-sided P-value|Log Rank|Strata: prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)|Ripretinib: Placebo; based on stratified Cox Proportional Hazards Regression Model using randomization stratification factors \[prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)\]|||0.25|0.09|<0.0001
70993892|NCT03353753|141496549|SUPERIORITY|||||||0.0504||||||Two-sided P-value|Fisher Exact|||||||0.0504
70993893|NCT03353753|141496551|SUPERIORITY||Hazard Ratio (HR)|0.36||||0.0004|TWO_SIDED|95.0|0.21|0.62||Not evaluated for statistical significance as a result of the sequential testing procedure for the secondary endpoints of ORR and OS.|Log Rank|Strata: prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)|Ripretinib: Placebo; based on stratified Cox Proportional Hazards Regression Model using randomization stratification factors \[prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)\]|||0.62|0.21|0.0004
70993894|NCT03353753|141496552|SUPERIORITY|||||||0.001||||||Not evaluated for statistical significance as a result of the sequential testing procedure for the secondary endpoints of ORR, OS, and QOL.|ANCOVA|Factors: prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)||||||0.001
70993895|NCT03353753|141496553|SUPERIORITY|||||||0.004||||||Not evaluated for statistical significance as a result of the sequential testing procedure for the secondary endpoints of ORR, OS, and QOL.|ANCOVA|Factors: prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)||||||0.004
70993896|NCT03353753|141496554|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
70993897|NCT00205699|141496574|SUPERIORITY||||||<|0.0001||||||The p value refers to the time by treatment condition interaction. The a priori threshold for statistical significance in this planned primary test was p\<0.05.|Mixed Models Analysis|||Primary analysis for change in DEXA % fat used a likelihood-based mixed-effects model using time (0, 6 and 12 weeks) and medication group as independent variables, with Toeplitz covariance structure specified, based on Bayesian information criteria (BIC). The null hypotheses were that there was no difference in the outcome over time (main effect of time) and that there were no differences between groups in the change over time (time by treatment condition).||||<0.0001
71099260|NCT02191397|141707283|OTHER||Mean Difference (Final Values)|0.2||||0.627|TWO_SIDED|95.0|-0.7|1.16||Analysis included Baseline MADRS total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||1.16|-0.70|0.627
70993898|NCT00205699|141496575|SUPERIORITY|||||||0.07|||||||ANCOVA|||||||0.07
70993899|NCT00205699|141496576|SUPERIORITY|||||||0.27|||||||ANCOVA|||||||0.27
70993900|NCT00205699|141496577|SUPERIORITY|||||||0.17|||||||ANCOVA|||||||0.17
70993901|NCT00205699|141496578|SUPERIORITY|||||||0.29|||||||ANCOVA|||||||0.29
70993902|NCT00205699|141496579|SUPERIORITY||||||<|0.003|||||||ANCOVA|||Repeated measures ANCOVA was used to test for the main effect of time on the outcome, and to test for a time by treatment condition interaction that would indicate differences between groups in change over time in the primary outcome. The null hypotheses were that there was no difference in the outcome over time (main effect of time) and that there were no differences between groups in the change over time (time by treatment condition).||||<0.003
70993903|NCT00205699|141496579|SUPERIORITY|||||||0.003||||||Bonferroni correction for multiple comparisons was applied (p\<0.05/4 = 0.0125).|Contrast|Contrasts based on the ANCOVA-derived time by treatment condition interaction.||||||0.003
70993904|NCT00205699|141496579|SUPERIORITY|||||||0.002||||||Bonferroni correction for multiple comparisons was applied (p\<0.05/4 = 0.0125).|ANCOVA|Contrasts based on the ANCOVA-derived time by treatment condition interaction.||||||0.002
70993905|NCT02093234|141496582|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
70993906|NCT02093234|141496583|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
70993907|NCT02093234|141496584|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
70993908|NCT02093234|141496585|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon signed rank|||||||0.02
70993909|NCT01114373|141496590|SUPERIORITY_OR_OTHER|||||||0.0269|TWO_SIDED||||||ANOVA|||The null hypothesis was that there is no interaction between the order of randomization and the primary outcome measures.||||0.0269
70993910|NCT01114373|141496590|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||ANOVA|||||||0.84
70993911|NCT01114373|141496591|SUPERIORITY_OR_OTHER|||||||0.0492|TWO_SIDED||||||ANOVA|||The null hypothesis was that there is no interaction between the order of randomization and the primary outcome measures.||||0.0492
70993912|NCT01114373|141496591|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||ANOVA|||||||0.95
70993913|NCT01114373|141496592|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED||||||ANOVA|||||||0.91
70993914|NCT01114373|141496593|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||ANOVA|||||||0.88
70993915|NCT01114373|141496594|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||ANOVA|||||||0.16
70993916|NCT01114373|141496595|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||ANOVA|||||||0.12
70993917|NCT01114373|141496596|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||ANOVA|||||||0.12
70993918|NCT01114373|141496597|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||ANOVA|||||||0.21
71040004|NCT02377349|141587891|SUPERIORITY|Criterion: The lower limit (LL) of the 95% confidence interval (CI) of the GMC ratio \[dTpa Group-Mother/Control Group-Mother\] for anti-PT antibodies was greater than or equal to (≥) 1.5.|GMC ratio|8.47|||||TWO_SIDED|95.0|7.02|10.2|||2-sample t-test|The CI of the group GMC ratio were computed using two-sample t-test assuming heterogeneity of variance.||GMC ratio between groups (dTpa Group-Mother/Control Group-Mother) to demonstrate that maternally transferred antibodies against pertussis in the dTpa Group-Mother was superior to that in the Control Group-mother, in the cord blood sample at the time of delivery.||10.2|7.02|
71040005|NCT02377349|141587891|SUPERIORITY|Criterion: The lower limit (LL) of the 95% confidence interval (CI) of the GMC ratio \[dTpa Group-Mother/Control Group-Mother\] for anti-FHA antibodies was greater than or equal to (≥) 1.5.|GMC ratio|16.11|||||TWO_SIDED|95.0|13.48|19.24|||2-sample t-test|The CI of the group GMC ratio were computed using two-sample t-test assuming heterogeneity of variance.||GMC ratio between groups (dTpa Group-Mother/Control Group-Mother) to demonstrate that maternally transferred antibodies against pertussis in the dTpa Group-Mother was superior to that in the Control Group-mother, in the cord blood sample at the time of delivery.||19.24|13.48|
70993919|NCT01114373|141496598|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Friedman|||||||0.06
70993920|NCT01114373|141496599|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||Friedman|||||||0.21
70993921|NCT01114373|141496600|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Friedman|||||||0.41
70993922|NCT01114373|141496601|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||ANOVA|||||||0.13
70993923|NCT01114373|141496602|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||ANOVA|||||||0.58
70993924|NCT01114373|141496603|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||ANOVA|||||||0.39
70993925|NCT00421603|141496657|NON_INFERIORITY_OR_EQUIVALENCE|All analyses were conducted on the intent-to-treat sample of all randomized patients. All statistical tests were 2-tailed and employed at a significance level of 5%, unless otherwise stated. The original sample size of 120 patients was chosen to ensure sufficient power (at least 80%) of a two-sided test with level of significance α=0.05 for detecting difference between the two experimental treatments with respect to the percentage of subjects who achieve continuous 3-weeks abstinence.|||||=|0.05|||||||Chi-squared, Corrected|||The dichotomous primary outcome was analyzed using logistic regression with independent predictors: treatment (MAS-ER and topiramate vs. placebo) and adjusted for baseline severity of cocaine use (total number of cocaine use days in the 28 days prior to randomization).||||=.05
70993926|NCT03444870|141496660|SUPERIORITY||Difference in adjusted mean|-0.31|STANDARD_ERROR_OF_MEAN|0.18||0.0954|TWO_SIDED|95.0|-0.66|0.05|||ANCOVA|||Change from Baseline was calculated based on ANCOVA analysis model which included the following covariates and stratification factors =Treatment + Baseline (BL) + Geographic Region + Disease Stage + AD Medication at BL + Apolipoprotein E, Allele e4 (APOE e4) + Baseline Alzheimer Disease Assessment Scale-Cognition Subscale 13 (ADAS-Cog13) Score + Baseline Alzheimer Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL).||0.05|-0.66|0.0954
70993927|NCT03444870|141496662|SUPERIORITY||Difference in adjusted mean|-1.25|STANDARD_ERROR_OF_MEAN|0.65||0.0544|TWO_SIDED|95.0|-2.52|0.02|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||0.02|-2.52|0.0544
70993928|NCT03444870|141496663|SUPERIORITY||Difference in adjusted mean|1.11|STANDARD_ERROR_OF_MEAN|0.81||0.1729|TWO_SIDED|95.0|-0.48|2.7|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Region + Disease Stage + AD Medication at BL + APOE e4.||2.70|-0.48|0.1729
70993929|NCT03444870|141496664|SUPERIORITY||Difference in adjusted mean|-0.86|STANDARD_ERROR_OF_MEAN|0.42||0.0425|TWO_SIDED|95.0|-1.68|-0.03|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||-0.03|-1.68|0.0425
70993930|NCT03444870|141496665|SUPERIORITY||Difference in adjusted mean|0.32|STANDARD_ERROR_OF_MEAN|0.31||0.2904|TWO_SIDED|95.0|-0.28|0.93|||ANCOVA|||Change from Baseline was calculated based on ANCOVA analysis model which included the following covariates and stratification factors =Treatment + Baseline + Geographic Region + Disease Stage + AD Medication at BL + APOE e4.||0.93|-0.28|0.2904
71099261|NCT02191397|141707283|OTHER||Mean Difference (Final Values)|1.4||||0.037|TWO_SIDED|95.0|0.08|2.66||Analysis included Baseline MADRS total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||2.66|0.08|0.037
70993931|NCT03444870|141496666|SUPERIORITY||Difference in adjusted mean|-0.97|STANDARD_ERROR_OF_MEAN|0.6||0.1036|TWO_SIDED|95.0|-2.14|0.2|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||0.20|-2.14|0.1036
70993932|NCT03444870|141496667|SUPERIORITY||Difference in adjusted mean|-0.07|STANDARD_ERROR_OF_MEAN|0.37||0.8468|TWO_SIDED|95.0|-0.79|0.65|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||0.65|-0.79|0.8468
70993933|NCT03444870|141496668|SUPERIORITY||Difference in adjusted mean|0.2|STANDARD_ERROR_OF_MEAN|0.79||0.803|TWO_SIDED|95.0|-1.35|1.74|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||1.74|-1.35|0.8030
70993934|NCT03444870|141496669|SUPERIORITY||Difference in adjusted mean|1.0|STANDARD_ERROR_OF_MEAN|0.68||0.1439|TWO_SIDED|95.0|-0.34|2.34|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||2.34|-0.34|0.1439
70993935|NCT03444870|141496676|SUPERIORITY||Difference in adjusted means|-66.44|STANDARD_ERROR_OF_MEAN|4.171|<|0.0001|TWO_SIDED|95.0|-74.71|-58.16|||Mixed Model for Repeated Measures|||Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Type of Tracer + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||-58.16|-74.71|<.0001
70993936|NCT03444870|141496677|SUPERIORITY||Difference in adjusted mean|0.01|STANDARD_ERROR_OF_MEAN|0.023||0.7816|TWO_SIDED|95.0|-0.04|0.05|||Mixed Model for Repeated Measures|||Temporal Composite Region: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.05|-0.04|0.7816
70993937|NCT03444870|141496677|SUPERIORITY||Difference in adjusted means|0.01|STANDARD_ERROR_OF_MEAN|0.018||0.6203|TWO_SIDED|95.0|-0.03|0.05|||Mixed Model for Repeated Measures|||Medial Temporal Composite Region: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.05|-0.03|0.6203
71099262|NCT02191397|141707283|OTHER||Mean Difference (Final Values)|1.2||||0.143|TWO_SIDED|95.0|-0.4|2.78||Analysis included Baseline MADRS total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||2.78|-0.40|0.143
70993938|NCT03444870|141496677|SUPERIORITY||Difference in adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.015||0.7754|TWO_SIDED|95.0|-0.03|0.03|||Mixed Model for Repeated Measures|||Frontal Lobe: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.03|-0.03|0.7754
70993939|NCT03444870|141496677|SUPERIORITY||Difference in adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.026||0.9022|TWO_SIDED|95.0|-0.05|0.05|||Mixed Model for Repeated Measures|||Parietal Lobe: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.05|-0.05|0.9022
70993940|NCT03444870|141496678|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Parietal Lobe: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||||<.001
70993941|NCT03444870|141496679|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<.001
70993942|NCT03444870|141496680|SUPERIORITY|||||||0.396|||||||ANCOVA|||||||0.396
70993943|NCT03444870|141496681|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<.001
70993944|NCT01170702|141496703|NON_INFERIORITY|The non inferiority margin is clinically important reduction in 24 hour hydromorphone consumption of 25%, 37.5% and 50% absolute reduction, compared with control.|Median Difference (Final Values)|1.25|STANDARD_DEVIATION|0.05||0.05|TWO_SIDED|0.975|1.25|1.25|||Kruskal-Wallis|||||1.25|1.25|.05
71099263|NCT02191397|141707283|OTHER||Mean Difference (Final Values)|0.8||||0.33|TWO_SIDED|95.0|-0.81|2.4||Analysis included Baseline MADRS total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||2.40|-0.81|0.330
70993945|NCT01677507|141496711|OTHER||Mean Difference (Final Values)|2.8||||0.0001|TWO_SIDED|95.0|2.4|3.3|||t-test, 2 sided|Actually these are 2 sided paired t-tests.||Right Eye treated vs. untreated||3.3|2.4|0.0001
70993946|NCT01677507|141496711|OTHER||Mean Difference (Final Values)|2.8||||0.0001|TWO_SIDED|95.0|2.5|3.2|||t-test, 2 sided|paired t-test, 2 sided||Left Eye treated vs. untreated||3.2|2.5|0.0001
70993947|NCT01677507|141496711|OTHER||Mean Difference (Final Values)|3.0||||0.0001|TWO_SIDED|95.0|2.5|3.4|||t-test, 2 sided|paired t-test, 2 sided||Right Eye treated vs. untreated||3.4|2.5|0.0001
70993948|NCT01677507|141496711|OTHER||Mean Difference (Final Values)|2.9||||0.0001|TWO_SIDED|95.0|2.5|3.3|||t-test, 2 sided|paired t-test, 2 sided||Left Eye, treated vs. untreated||3.3|2.5|0.0001
70993949|NCT01677507|141496712|OTHER||Median Difference (Final Values)|1.1||||0.0001|TWO_SIDED|95.0|0.9|1.3|||t-test, 2 sided|paired t test, 2 sided||Right Eye treated to untreated||1.3|0.9|0.0001
70993950|NCT01677507|141496712|OTHER||Median Difference (Final Values)|0.9||||0.0001|TWO_SIDED|95.0|0.7|1.1|||t-test, 2 sided|paired t test, 2 sided||Left Eye, treated vs. untreated||1.1|0.7|0.0001
70993951|NCT01677507|141496712|OTHER||Mean Difference (Final Values)|0.01||||0.94|TWO_SIDED|95.0|-0.2|0.2|||t-test, 2 sided|paired t-test||Right Eye, treated vs. untreated||0.2|-0.2|0.94
70993952|NCT01677507|141496712|OTHER||Mean Difference (Final Values)|0.05||||0.54|TWO_SIDED|95.0|-0.1|0.2|||t-test, 2 sided|paired t-test, 2 sided||Left Eye, treated vs. untreated||0.2|-0.1|0.54
70993953|NCT01677507|141496713|OTHER||Mean Difference (Final Values)|0.4||||0.04|TWO_SIDED|95.0|0.01|0.7|||t-test, 2 sided|paired t-test, 2 sided||Right Eye, treated vs. untreated||0.7|0.01|0.04
71099264|NCT02191397|141707283|OTHER||Mean Difference (Final Values)|0.9||||0.278|TWO_SIDED|95.0|-0.69|2.4||Analysis included Baseline MADRS total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||2.40|-0.69|0.278
70993954|NCT01677507|141496713|OTHER||Mean Difference (Final Values)|0.2||||0.15|TWO_SIDED|95.0|-0.1|0.6|||t-test, 2 sided|paired t-test, 2 sided||Left eye, treated vs. untreated||0.6|-0.1|0.15
70993955|NCT01677507|141496713|OTHER||Mean Difference (Final Values)|0.1||||0.52|TWO_SIDED|95.0|-0.3|0.6|||t-test, 2 sided|paired t-test, 2 sided||Right Eye, treated vs. untreated||0.6|-0.3|0.52
70993956|NCT01677507|141496713|OTHER||Mean Difference (Final Values)|0.03||||0.88|TWO_SIDED|95.0|-0.4|0.4|||t-test, 2 sided|paired t-test, 2 sided||Left Eye, treated vs. untreated||0.4|-0.4|0.88
70993957|NCT00084929|141496765|OTHER||Area Under the Curve (AUC)|0.89|||||TWO_SIDED|95.0|0.853|0.933||||||Accuracy: ROC analysis Receiver-operating-characteristic (ROC) curves were estimated with the use of data pooled from the radiologists because of the small number of positive cases reviewed by each radiologist.||0.933|0.853|
70993958|NCT00084929|141496765|OTHER||"Sensitivity: P(T+|D+)"|0.9|||||TWO_SIDED|95.0|0.838|0.96|||||Exact 95% confidence intervals were calculated for each radiologist, and large-sample 95% confidence intervals were calculated for overall estimates, with the use of standard errors that allowed for estimation of variation among radiologists.|"Sensitivity, for each radiologist, was calculated as the percentage of patients with lesions that were larger than or equal to the prespecified threshold and that were detected on both colonoscopy and CT colonography.~The per-patient sensitivity, specificity, positive predictive value, and negative predictive value were first estimated for each radiologist, and then the average values among the radiologists were calculated."||0.96|0.838|
70993959|NCT00084929|141496765|OTHER||"P(T-|D-)"|0.86|||||TWO_SIDED|95.0|0.813|0.9|||||Exact 95% confidence intervals were calculated for each radiologist, and large-sample 95% confidence intervals were calculated for overall estimates, with the use of standard errors that allowed for estimation of variation among radiologists.|Specificity, for each radiologist, was calculated as the percentage of patients who did not have lesions larger than the prespecified threshold on colonoscopy as well as CT colonography The per-patient sensitivity, specificity, positive predictive value, and negative predictive value were first estimated for each radiologist, and then the average values among the radiologists were calculated.||0.9|0.813|
70993960|NCT00084929|141496765|OTHER||"P(D+|T+)"|0.23|||||TWO_SIDED|95.0|0.194|0.273|||||Exact 95% confidence intervals were calculated for each radiologist, and large-sample 95% confidence intervals were calculated for overall estimates, with the use of standard errors that allowed for estimation of variation among radiologists.|Positive Predictive Value (PPV) the positive predictive value was calculated as the percentage of patients with CT colonographic findings that were also seen on colonoscopy||0.273|0.194|
70993961|NCT00084929|141496765|OTHER||"P(D-|T-)"|0.99|||||TWO_SIDED|95.0|0.99|0.998|||||Exact 95% confidence intervals were calculated for each radiologist, and large-sample 95% confidence intervals were calculated for overall estimates, with the use of standard errors that allowed for estimation of variation among radiologists.|Negative Predictive Value (NPV) the negative predictive value was calculated as the percentage of patients with no CT colonographic findings larger than the prespecified threshold that were not detected on colonoscopy.||0.998|0.990|
70993962|NCT00084929|141496766|OTHER||Area Under the Curve (AUC)|0.89|||||TWO_SIDED|95.0|0.853|0.93||||||"Accuracy: ROC analysis CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered detected"||0.93|0.853|
70993963|NCT00084929|141496766|OTHER||"Sensitivity: P(T+|D+)"|0.9|||||TWO_SIDED|95.0|0.832|0.96|||||Sensitivity indicates the percent of patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|"Sensitivity CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered detected"||0.96|0.832|
70993964|NCT00084929|141496766|OTHER||"P(T-|D-)"|0.86|||||TWO_SIDED|95.0|0.817|0.902|||||Specificity indicates the percent of patients who had not lesions detected on optical colonoscopy, who had no lesions detected on CTC.|"Specificity CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered detected"||0.902|0.817|
70993965|NCT00084929|141496766|OTHER||"P(D+|T+)"|0.25|||||TWO_SIDED|95.0|0.209|0.292||||||"Positive Predictive Value (PPV) CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered detected"||0.292|0.209|
70993966|NCT00084929|141496766|OTHER||"P(D-|T-)"|0.99|||||TWO_SIDED|95.0|0.99|0.998||||||"Negative Predictive Value (NPV) CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered detected"||0.998|0.990|
70993967|NCT00084929|141496767|OTHER||Area Under the Curve (AUC)|0.88|||||TWO_SIDED|95.0|0.842|0.913||||||Accuracy: ROC analysis||0.913|0.842|
70993968|NCT00084929|141496767|OTHER||"Sensitivity: P(T+|D+)"|0.87|||||TWO_SIDED|95.0|0.803|0.929|||||Sensitivity indicates the percent of patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity||0.929|0.803|
70993969|NCT00084929|141496767|OTHER||"P(T-|D-)"|0.87|||||TWO_SIDED|95.0|0.825|0.909|||||Specificity indicates the percent of patients who had not lesions detected on optical colonoscopy, who had no lesions detected on CTC.|Specificity||0.909|0.825|
70993970|NCT00084929|141496767|OTHER||"P(D+|T+)"|0.31|||||TWO_SIDED|95.0|0.256|0.355||||||Positive Predictive Value (PPV)||0.355|0.256|
70993971|NCT00084929|141496767|OTHER||"P(D-|T-)"|0.99|||||TWO_SIDED|95.0|0.984|0.994||||||Negative Predictive Value (NPV)||0.994|0.984|
70993972|NCT00084929|141496768|OTHER||Area Under the Curve (AUC)|0.87|||||TWO_SIDED|95.0|0.833|0.902||||||Accuracy: ROC analysis||0.902|0.833|
70993973|NCT00084929|141496768|OTHER||"Sensitivity: P(T+|D+)"|0.84|||||TWO_SIDED|95.0|0.776|0.912|||||Sensitivity indicates the percent of patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity||0.912|0.776|
70993974|NCT00084929|141496768|OTHER||"P(T-|D-)"|0.87|||||TWO_SIDED|95.0|0.831|0.914|||||Specificity indicates the percent of patients who had not lesions detected on optical colonoscopy, who had no lesions detected on CTC.|Specificity||0.914|0.831|
70993975|NCT00084929|141496768|OTHER||"P(D+|T+)"|0.35|||||TWO_SIDED|95.0|0.299|0.397||||||Positive Predictive Value (PPV)||0.397|0.299|
70993976|NCT00084929|141496768|OTHER||"P(D-|T-)"|0.99|||||TWO_SIDED|95.0|0.98|0.992||||||Negative Predictive Value (NPV)||0.992|0.980|
70993977|NCT00084929|141496769|OTHER||Area Under the Curve (AUC)|0.84|||||TWO_SIDED|95.0|0.81|0.878||||||Accuracy: ROC analysis||0.878|0.810|
70993978|NCT00084929|141496769|OTHER||"Sensitivity: P(T+|D+)"|0.78|||||TWO_SIDED|95.0|0.711|0.849|||||Sensitivity indicates the percent of patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity||0.849|0.711|
70993979|NCT00084929|141496769|OTHER||"P(T-|D-)"|0.88|||||TWO_SIDED|95.0|0.84|0.92|||||Specificity indicates the percent of patients who had not lesions detected on optical colonoscopy, who had no lesions detected on CTC.|Specificity||0.92|0.840|
70993980|NCT00084929|141496769|OTHER||"P(D+|T+)"|0.4|||||TWO_SIDED|95.0|0.335|0.463||||||Positive Predictive Value (PPV)||0.463|0.335|
70993981|NCT00084929|141496769|OTHER||"P(D-|T-)"|0.98|||||TWO_SIDED|95.0|0.971|0.984||||||Negative Predictive Value (NPV)||0.984|0.971|
70993982|NCT00084929|141496770|OTHER||Area Under the Curve (AUC)|0.8|||||TWO_SIDED|95.0|0.763|0.828||||||Accuracy: ROC analysis||0.828|0.763|
70993983|NCT00084929|141496770|OTHER||"Sensitivity: P(T+|D+)"|0.65|||||TWO_SIDED|95.0|0.579|0.727|||||Sensitivity indicates the percent of patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity||0.727|0.579|
70993984|NCT00084929|141496770|OTHER||"P(T-|D-)"|0.89|||||TWO_SIDED|95.0|0.851|0.923|||||Specificity indicates the percent of patients who had not lesions detected on optical colonoscopy, who had no lesions detected on CTC.|Specificity||0.923|0.851|
70993985|NCT00084929|141496770|OTHER||"P(D+|T+)"|0.45|||||TWO_SIDED|95.0|0.389|0.513||||||Positive Predictive Value (PPV)||0.513|0.389|
70993986|NCT00084929|141496770|OTHER||"P(D-|T-)"|0.95|||||TWO_SIDED|95.0|0.941|0.965||||||Negative Predictive Value (NPV)||0.965|0.941|
70993987|NCT00084929|141496771|OTHER||"Sensitivity: P(T+|D+)"|0.84|STANDARD_ERROR_OF_MEAN|0.043|||||||||||Sensitivity indicates the percent of lesions in patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity (per lesion (\>=10mm))||||
70993988|NCT00084929|141496772|OTHER||"Sensitivity: P(T+|D+)"|0.82|STANDARD_ERROR_OF_MEAN|0.042|||||||||||Sensitivity indicates the percent of lesions in patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity (per lesion (\>=9mm))||||
70993989|NCT00084929|141496773|OTHER||"Sensitivity: P(T+|D+)"|0.8|STANDARD_ERROR_OF_MEAN|0.041|||TWO_SIDED||||||||Sensitivity indicates the percent of lesions in patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity (per lesion \>=8mm)||||
70993990|NCT00084929|141496774|OTHER||"Sensitivity: P(T+|D+)"|0.75|STANDARD_ERROR_OF_MEAN|0.042|||||||||||Sensitivity indicates the percent of lesions in patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity (per lesion \>=7mm)||||
70993991|NCT00084929|141496775|OTHER||"Sensitivity: P(T+|D+)"|0.7|STANDARD_ERROR_OF_MEAN|0.046|||||||||||Sensitivity indicates the percent of lesions in patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity (per lesion \>=6mm)||||
70923388|NCT03052608|141338192|SUPERIORITY||Mean Difference (Net)|-12.03|||<|0.0001|TWO_SIDED|95.0|-15.49|-8.58|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Diarrhea. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-8.58|-15.49|<0.0001
71099265|NCT02191397|141707284|OTHER||Mean Difference (Final Values)|0.0||||0.579|TWO_SIDED|95.0|-0.09|0.16||Analysis included Baseline HAMD-17 depressed mood subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.16|-0.09|0.579
71099266|NCT02191397|141707284|OTHER||Mean Difference (Final Values)|0.1||||0.163|TWO_SIDED|95.0|-0.04|0.26||Analysis included Baseline HAMD-17 depressed mood subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.26|-0.04|0.163
71099267|NCT02191397|141707284|OTHER||Mean Difference (Final Values)|0.2||||0.05|TWO_SIDED|95.0|0.0|0.34||Analysis included Baseline HAMD-17 depressed mood subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.34|0.00|0.050
71099268|NCT02191397|141707284|OTHER||Mean Difference (Final Values)|0.1||||0.337|TWO_SIDED|95.0|-0.09|0.26||Analysis included Baseline HAMD-17 depressed mood subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.26|-0.09|0.337
71099269|NCT02191397|141707284|OTHER||Mean Difference (Final Values)|0.0||||0.714|TWO_SIDED|95.0|-0.14|0.2||Analysis included Baseline HAMD-17 depressed mood subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.20|-0.14|0.714
70923389|NCT03052608|141338192|SUPERIORITY||Mean Difference (Net)|-1.04||||0.5947|TWO_SIDED|95.0|-4.9|2.82|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Financial Difficulties. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||2.82|-4.90|0.5947
70923390|NCT03052608|141338193|SUPERIORITY||Mean Difference (Net)|0.55||||0.7254|TWO_SIDED|95.0|-2.51|3.6|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Dyspnoea. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||3.60|-2.51|0.7254
70923391|NCT03052608|141338193|SUPERIORITY||Mean Difference (Net)|-4.55||||0.0115|TWO_SIDED|95.0|-8.06|-1.03|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Coughing. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-1.03|-8.06|0.0115
70923392|NCT03052608|141338193|SUPERIORITY||Mean Difference (Net)|0.12||||0.7824|TWO_SIDED|95.0|-0.75|0.99|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Haemoptysis. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||0.99|-0.75|0.7824
70993992|NCT00084929|141496776|OTHER||"Sensitivity: P(T+|D+)"|0.59|STANDARD_ERROR_OF_MEAN|0.045|||||||||||Sensitivity indicates the percent of lesions in patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity (per lesion \>=5mm)||||
70993993|NCT00077610|141496780|NON_INFERIORITY_OR_EQUIVALENCE|The two RO0503821 dosing schedules were compared separately to epoetin reference using ANCOVA, with Hb at BL and region as the covariates. The test for non-inferiority was based on the lower limit of the two-sided 97.5% confidence interval for the difference between the two groups. When the lower limit was greater than or equal to -0.75 g/dL, the RO0503821 groups were regarded as non-inferior to the epoetin reference group. The confidence level of 97.5% was chosen to adjust for multiplicity.|Mean Difference between groups|0.004|STANDARD_ERROR_OF_MEAN|0.0973|<|0.0001|TWO_SIDED|97.5|-0.215|0.223|||ANCOVA, CI for difference between groups||Difference between groups based on the adjusted means derived from the ANCOVA model|The non-inferiority test for treatment differences in Hb change from baseline, based on analysis of co-variance (ANCOVA) analysis with a non-inferiority limit of -0.75 g/dL.||0.223|-0.215|<0.0001
70923393|NCT03052608|141338193|SUPERIORITY||Mean Difference (Net)|1.16||||0.2988|TWO_SIDED|95.0|-1.04|3.36|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Sore Mouth. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||3.36|-1.04|0.2988
70923394|NCT03052608|141338193|SUPERIORITY||Mean Difference (Net)|-1.51||||0.1916|TWO_SIDED|95.0|-3.79|0.76|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Dysphagia. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||0.76|-3.79|0.1916
70923395|NCT03052608|141338193|SUPERIORITY||Mean Difference (Net)|5.37||||0.0279|TWO_SIDED|95.0|0.59|10.15|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Peripheral Neuropathy. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||10.15|0.59|0.0279
71099270|NCT02191397|141707285|OTHER||Mean Difference (Final Values)|-0.2||||0.358|TWO_SIDED|95.0|-0.5|0.18||Analysis included Baseline HAMD-17 anxiety/somatization subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.18|-0.50|0.358
70923396|NCT03052608|141338193|SUPERIORITY||Mean Difference (Net)|-0.2||||0.9162|TWO_SIDED|95.0|-3.89|3.49|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Alopecia. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||3.49|-3.89|0.9162
70993994|NCT00077610|141496780|NON_INFERIORITY_OR_EQUIVALENCE|The two RO0503821 dosing schedules were compared separately to epoetin reference using ANCOVA, with Hb at BL and region as the covariates. The test for non-inferiority was based on the lower limit of the two-sided 97.5% confidence interval for the difference between the two groups. When the lower limit was greater than or equal to -0.3 g/dL, the RO0503821 groups were regarded as non-inferior to the epoetin reference group. The confidence level of 97.5% was chosen to adjust for multiplicity.|Mean Difference between groups|0.051|STANDARD_ERROR_OF_MEAN|0.0997|<|0.0001|TWO_SIDED|97.5|-0.173|0.275|||ANCOVA, CI for difference between groups||Difference between groups based on the adjusted means derived from the ANCOVA model|The non-inferiority test for treatment differences in Hb change from baseline, based on ANCOVA analysis with a non-inferiority limit of -0.75 g/dL.||0.275|-0.173|<0.0001
70993995|NCT04124042|141496788|SUPERIORITY||Odds Ratio (OR)|0.655|||||TWO_SIDED|95.0|0.347|1.237||||||||1.237|0.347|
70993996|NCT04124042|141496788|SUPERIORITY||Odds Ratio (OR)|0.714|||||TWO_SIDED|95.0|0.381|1.336||||||||1.336|0.381|
70993997|NCT04124042|141496789|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.539||0.413|TWO_SIDED|95.0|-0.62|1.5|||Mixed Models Analysis|||||1.50|-0.62|0.413
70993998|NCT04124042|141496789|SUPERIORITY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.535||0.629|TWO_SIDED|95.0|-0.79|1.31|||Mixed Models Analysis|||||1.31|-0.79|0.629
70993999|NCT04124042|141496794|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.1374|TWO_SIDED|95.0|-0.16|1.16|||Mixed Models Analysis|||||1.16|-0.16|0.1374
70994000|NCT04124042|141496794|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.2807|TWO_SIDED|95.0|-0.29|1.0|||Mixed Models Analysis|||||1.00|-0.29|0.2807
70994001|NCT04124042|141496795|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.142||0.346|TWO_SIDED|95.0|-0.14|0.41|||Mixed Models Analysis|||||0.41|-0.14|0.346
70994002|NCT04124042|141496795|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.14||0.968|TWO_SIDED|95.0|-0.27|0.28|||Mixed Models Analysis|||||0.28|-0.27|0.968
70994003|NCT04124042|141496797|SUPERIORITY||Mean Difference (Final Values)|-2.83||||0.0081|TWO_SIDED|95.0|-4.91|-0.75|||Mixed Models Analysis|||Outcome measure #10 is an analysis of 2 tx groups (two doses of 0.45 mg/ml vs. a single dose of 0.45 mg/ml), whereas outcome measure #12 is all 6 tx groups. A MMRM model was used. LS Means in an MMRM model are influenced by the overall mean structure and covariance estimation. When fewer treatment groups are included, the model adjusts based on a different subset of data, leading to potential shifts in estimated LS Means due to changes in the reference population/covariance structure.||-0.75|-4.91|0.0081
70994004|NCT04124042|141496798|SUPERIORITY||Mean Difference (Final Values)|-9.6||||0.0101|TWO_SIDED|95.0|-16.85|-2.34|||Mixed Models Analysis|||Outcome measure #11 is an analysis of 2 tx groups (two doses of 0.45 mg/ml vs. a single dose of 0.45 mg/ml), whereas outcome measure #13 is all 6 tx groups. A MMRM model was used. LS Means in an MMRM model are influenced by the overall mean structure and covariance estimation. When fewer treatment groups are included, the model adjusts based on a different subset of data, leading to potential shifts in estimated LS Means due to changes in the reference population/covariance structure.||-2.34|-16.85|0.0101
70994005|NCT01551758|141496821|SUPERIORITY_OR_OTHER||Adjusted treatment ratio|0.92|||=|0.025|TWO_SIDED|95.0|0.85|0.99|||Generalized Linear Model|||||0.99|0.85|=0.025
70994006|NCT01551758|141496822|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the upper limit of the two-sided 95% confidence interval for the incidence ratio is less than 2.|Incidence ratio|1.1|||||TWO_SIDED|95.0|0.9|1.5|||||Calculated as % of participants who had at least one SAE of pneumonia in the FF/VI group divided by the % of participants who had at least one SAE of pneumonia in the Usual Care group|||1.5|0.9|
70994007|NCT01551758|141496823|SUPERIORITY_OR_OTHER||Adjusted treatment ratio|1.08||||0.632|TWO_SIDED|95.0|0.79|1.47|||Generalized linear model|||||1.47|0.79|0.632
70994008|NCT01551758|141496824|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13|||=|0.439|TWO_SIDED|95.0|0.83|1.52|||Cox proportional hazards model|||||1.52|0.83|=0.439
70994009|NCT01551758|141496825|SUPERIORITY_OR_OTHER||Adjusted treatment ratio|1.06||||0.488|TWO_SIDED|95.0|0.89|1.27|||Generalized linear model|||||1.27|0.89|0.488
70994010|NCT01551758|141496826|SUPERIORITY_OR_OTHER||Adjusted treatment ratio|0.98||||0.622|TWO_SIDED|95.0|0.92|1.05|||Generalized linear model|||||1.05|0.92|0.622
70994011|NCT01551758|141496827|SUPERIORITY_OR_OTHER||Adjusted treatment ratio|1.05||||0.336|TWO_SIDED|95.0|0.95|1.15|||Generalized Linear Model|||||1.15|0.95|0.336
70994012|NCT01551758|141496828|SUPERIORITY_OR_OTHER||Adjusted treatment ratio|1.12|||<|0.001|TWO_SIDED|95.0|1.05|1.2|||Generalized Linear Model|||||1.20|1.05|<0.001
70994013|NCT01551758|141496829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.89|||<|0.001|TWO_SIDED|95.0|1.6|2.23|||Cox proportional hazards model||A hazard ratio \<1 indicates a lower risk with FF/VI compared with Usual Care.|||2.23|1.60|<0.001
70994014|NCT01551758|141496830|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.37|0.66|||Cox proprotional hazards model||A hazard ratio \<1 indicates a lower risk with FF/VI compared with Usual Care|||0.66|0.37|<0.001
70994015|NCT01551758|141496831|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.111|TWO_SIDED|95.0|0.85|1.02|||Cox porportional hazards model||A hazard ratio \<1 indicates a lower risk with FF/VI compared with Usual Care|||1.02|0.85|0.111
70994016|NCT01551758|141496832|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.081|TWO_SIDED|95.0|0.84|1.01|||Cox porportional hazards model|||||1.01|0.84|0.081
70994017|NCT01551758|141496833|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.27||||0.075|TWO_SIDED|95.0|0.98|1.66|||Cox proportional hazards model|||||1.66|0.98|0.075
70994018|NCT00906074|141496840|SUPERIORITY_OR_OTHER|||||||0.881|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||Neoplasm||||0.881
70994019|NCT00906074|141496840|SUPERIORITY_OR_OTHER|||||||0.517|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||Tobacco use||||0.517
70994020|NCT00906074|141496840|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||BMI(kg/mˆ2)\>30||||0.053
70994021|NCT00906074|141496840|SUPERIORITY_OR_OTHER|||||||0.289|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||Diabetes mellitus||||0.289
70994022|NCT00906074|141496840|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||Immunosuppression/Corticosteroids||||1.000
70994023|NCT00906074|141496840|SUPERIORITY_OR_OTHER|||||||0.169|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||Anemia (Hb\<9gr/dL)||||0.169
70994024|NCT00906074|141496840|SUPERIORITY_OR_OTHER|||||||0.637|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||Malnutrition (hypoalbuminemia)||||0.637
70994025|NCT00906074|141496841|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||||||1.000
70994026|NCT00906074|141496842|SUPERIORITY_OR_OTHER|||||||0.873|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||||||0.873
70994027|NCT00906074|141496847|SUPERIORITY_OR_OTHER|||||||0.156|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||||||0.156
70994028|NCT00906074|141496848|SUPERIORITY_OR_OTHER|||||||0.444|TWO_SIDED||||||Fisher Exact|||||||0.444
70994029|NCT00753935|141496853|SUPERIORITY|||||||0.005|||||||Wilcoxon rank-sum|||||||0.005
70994030|NCT03282357|141496855|NON_INFERIORITY|Non-inferiority margin, delta = 10 percent (%). The two-sided 95% confidence interval (CI) for the differences between percentages was constructed using the Newcombe's recommended method.|Difference in Percentage|-6.8|||||TWO_SIDED|95.0|-13.1|-0.5||||||||-0.5|-13.1|
70994031|NCT03282357|141496856|NON_INFERIORITY|Non-inferiority margin, delta = 15%. The two-sided 95% CI for the differences between percentages was constructed using the Newcombe's recommended method.|Difference in Percentage|-4.9|||||TWO_SIDED|95.0|-9.8|-0.3||||||||-0.3|-9.8|
70994032|NCT01586156|141496857|SUPERIORITY|||||||0.04|||||||ANOVA|||||||0.04
70994033|NCT01586156|141496858|SUPERIORITY|||||||0.04|||||||ANOVA|||||||0.04
70994034|NCT01586156|141496859|OTHER|Pearson's correlation test of association of alprenolol binding changes to dose carvedilol.||||||0.02||||||Correlation of the change in alprenolol binding relative to dose carvedilol.|Pearson|||||||0.02
70994035|NCT01586156|141496860|SUPERIORITY|||||||0.05|||||||ANOVA|||||||0.05
70994036|NCT01586156|141496862|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
70994037|NCT01586156|141496863|NON_INFERIORITY|Carvedilol did not lead to worse cardiac output as compared to placebo.||||||0.8|||||||ANOVA|||||||0.8
70994038|NCT02121756|141496868|OTHER|The sCD14 is measured in pg/ml and the median change is shown in pg/ml. the linear regression for the between arm comparison of baseline to week 12 change was performed using log10 transformed plasma sCD14||||||0.822|||||||Regression, Linear|||||||0.8220
70994039|NCT02121756|141496869|OTHER|The sCD163 is measured in ng/ml and the median change is shown in ng/ml. the linear regression for the between arm comparison of baseline to week 12 change was performed using log10 transformed plasma sCD163.||||||0.0869|||||||Regression, Linear|||||||0.0869
70994040|NCT02121756|141496870|OTHER|The IL-6 is measured in pg/ml and the median change is shown in pg/ml. the linear regression for the between arm comparison of baseline to week 12 change was performed using log10 transformed plasma IL-6.||||||0.5027|||||||Regression, Linear|||||||0.5027
70994041|NCT02121756|141496871|OTHER|||||||0.4548|||||||Mixed Models Analysis|||||||0.4548
70994042|NCT02121756|141496873|OTHER|||||||0.7556|||||||Mixed Models Analysis|||||||0.7556
70994043|NCT02121756|141496874|OTHER|||||||0.2075|||||||Mixed Models Analysis|||||||0.2075
70994044|NCT02121756|141496875|OTHER|||||||0.0315|||||||Mixed Models Analysis|||||||0.0315
70994045|NCT02121756|141496876|OTHER|||||||0.7376|||||||Mixed Models Analysis|||||||0.7376
70994046|NCT02121756|141496877|OTHER|||||||0.2343|||||||Mixed Models Analysis|||||||0.2343
70994047|NCT02121756|141496878|OTHER|||||||0.7598|||||||Mixed Models Analysis|||||||0.7598
70994048|NCT02121756|141496879|OTHER|||||||0.983|||||||Mixed Models Analysis|||||||0.9830
70994049|NCT02121756|141496880|OTHER|||||||0.3317|||||||Mixed Models Analysis|||||||0.3317
70994050|NCT02121756|141496881|OTHER|||||||0.6121|||||||Mixed Models Analysis|||||||0.6121
70994051|NCT02121756|141496882|OTHER|||||||0.562|||||||Mixed Models Analysis|||||||0.5620
70994052|NCT01179347|141496887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.64|STANDARD_ERROR_OF_MEAN|0.97||0.092||95.0|-0.27|3.55||Two-sided p-value.|Mixed Models Analysis|Restricted maximum likelihood (REML)-based MMRM. Adjusted for treatment, visit, treatment-by-visit, age group, baseline and baseline-by-visit.|Tio R5 qd minus Placebo.|Hierarchical testing procedure was applied for both co-primary endpoints to maintain the overall alpha level. If and only if statistical superiority of the Tio R5 qd compared to Placebo in FEV1 AUC0-4h was demonstrated at the 1 sided alpha level of 0.025, confirmatory comparison in the second co-primary endpoint, at the same alpha level of 0.025 could be done .||3.55|-0.27|0.092
70994053|NCT01179347|141496888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|0.97||0.15||95.0|-0.5|3.3||Two-sided p-value.|Mixed Models Analysis|REML-based MMRM. Adjusted for treatment, visit, treatment-by-visit, age group, baseline and baseline-by-visit.|Tio R5 qd minus Placebo.|Hierarchical testing for co-primary endpoints, confirmatory only if previous hypotheses had been successful,||3.30|-0.50|0.15
70994054|NCT01179347|141496889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.09|STANDARD_ERROR_OF_MEAN|0.9||0.23||95.0|-0.68|2.86||Two-sided p-value.|Mixed Models Analysis|REML-based MMRM. Adjusted for treatment, visit, treatment-by-visit, age group, baseline and baseline-by-visit.|Tio R5 qd minus Placebo.|||2.86|-0.68|0.23
70994055|NCT01179347|141496890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|0.93||0.19||95.0|-0.62|3.02||Two-sided p-value.|Mixed Models Analysis|REML-based MMRM. Adjusted for treatment, visit, treatment-by-visit, age group, baseline and baseline-by-visit.|Tio R5 qd minus Placebo.|||3.02|-0.62|0.19
70994056|NCT01179347|141496891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|1.76||0.62||95.0|-2.59|4.32||Two-sided p-value.|Mixed Models Analysis|REML-based MMRM. Adjusted for treatment, visit, treatment-by-visit, age group, baseline and baseline-by-visit.|Tio R5 qd minus Placebo.|||4.32|-2.59|0.62
71099271|NCT02191397|141707285|OTHER||Mean Difference (Final Values)|0.4||||0.081|TWO_SIDED|95.0|-0.04|0.75||Analysis included Baseline HAMD-17 anxiety/somatization subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.75|-0.04|0.081
71099272|NCT02191397|141707285|OTHER||Mean Difference (Final Values)|0.5||||0.062|TWO_SIDED|95.0|-0.02|0.99||Analysis included Baseline HAMD-17 anxiety/somatization subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.99|-0.02|0.062
70994057|NCT01179347|141496892|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.092||||0.84||95.0|0.453|2.633||Two-sided p-value.|Regression, Logistic|Adjusted for treatment, age group, baseline weight and baseline FEV1 percent predicted.|Tio R5 qd versus Placebo.|||2.633|0.453|0.84
70994058|NCT03342937|141496894|SUPERIORITY|1-sided test of single exponential mean with historical null hypothesis of 5.5 months median PFS||||||0.02||||||Sample size of 35 patients was chosen based on detecting the difference between a historical median PFS of 5.5 months and experimental median of 7.3 months, a hazard ratio of 0.75, with 80% power (1-sided test of single exponential mean, α=0.2).|1-sided exponential test|||||||0.02
70994059|NCT01546285|141497026|NON_INFERIORITY_OR_EQUIVALENCE|This study is to show a mean difference of less than 5mmHg and a standard deviation less than 8mmHg for the difference in systolic, diastolic, and mean BP readings taken by B40 and PRO1000 patient monitors.|Mean Difference (Final Values)|-1.4|STANDARD_DEVIATION|4.8|||TWO_SIDED|95.0|-2.58|-0.22|||Compare the mean difference with 5mmHg|||A total of no less than 65 subjects are needed for this study. Assuming a mean of no more than 4 mmHg and a standard deviation of no more than 5 mmHg for the difference, this sample size ensures that the percent of subjects with equivalent NIBP is at least 80% with 90% confidence. The difference between the B40 and PRO1000 patient monitors in systolic, diastolic, and mean BP determinations will be compared. A difference of within 10 mmHg is considered equivalent in NIBP.||-0.22|-2.58|
70994060|NCT01546285|141497026|NON_INFERIORITY_OR_EQUIVALENCE|This study is to show a mean difference of less than 5mmHg and a standard deviation less than 8mmHg for the difference in systolic, diastolic, and mean BP readings taken by B40 and PRO1000 patient monitors.|Mean Difference (Final Values)|-3.3|STANDARD_DEVIATION|2.6|||TWO_SIDED|95.0|-3.95|-2.66||||||A total of no less than 65 subjects are needed for this study. Assuming a mean of no more than 4mmHg and a standard deviation of no more than 5mmHg for the difference, this sample size ensures that the percent of subjects with equivalent NIBP is a least 80% with 90% confidence. The difference between the B40 and PRO1000 patient monitors in the systolic, diastolic, and mean BP determinations will be compared. A difference of within 10mmHg is considered equivalent in NIBP.||-2.66|-3.95|
70994061|NCT01546285|141497026|NON_INFERIORITY_OR_EQUIVALENCE|This study is to show a mean difference of less than 5mmHg and a standard deviation less than 8mmHg for the difference in systolic, diastolic, and mean BP readings taken by B40 and PRO1000 patient monitors.|Mean Difference (Final Values)|-3.7|STANDARD_DEVIATION|4.2|||TWO_SIDED|95.0|-4.73|-2.67||||||A total of no less than 65 subjects are needed for this study. Assuming a mean of no more than 4mmHg and a standard deviation of no more than 5mmHg for the difference, this sample size ensures that the percent of subjects with equivalent NIBP is a least 80% with 90% confidence. The difference between the B40 and PRO1000 patient monitors in the systolic, diastolic, and mean BP determinations will be compared. A difference of within 10mmHg is considered equivalent in NIBP.||-2.67|-4.73|
70994062|NCT01709786|141497035|SUPERIORITY_OR_OTHER||Bland-Altman Analysis|1.49|||||TWO_SIDED|||||p-value is not reported since Bland-Altman is not a hypothesis testing framework.|Limits of agreement||Limits of agreement are -2.02 to 5.00. This is not a confidence interval because Bland-Altman is not a hypothesis testing framework.|||||
70994063|NCT01709786|141497036|SUPERIORITY_OR_OTHER||Limits of agreement|-0.63|||||TWO_SIDED|||||p-value not reported since Bland-Altman is not a hypothesis testing framework.|Bland-Altman Analysis||Limits of agreement are -3.44 to 2.18. This is not a confidence interval because Bland-Altman is not a hypothesis testing framework.|||||
70994064|NCT01205451|141497043|SUPERIORITY_OR_OTHER||t-distribution|-1.21|||<|0.0001|TWO_SIDED|95.0|-1.38|-1.04||The P-value for change from Baseline indicates the comparision of the Week 6 value against the Baseline value.|Wilcoxon signed-rank test||Confidence intervals for means were based on the t-distribution.|||-1.04|-1.38|<0.0001
70994065|NCT01205451|141497043|SUPERIORITY_OR_OTHER||t-distribution|-1.33|||<|0.0001|TWO_SIDED|95.0|-1.54|-1.12||The P-value for change from Baseline indicates the comparision of the Week 6 value against the Baseline value.|Wilcoxon signed-rank test||Confidence intervals for means were based on the t-distribution.|||-1.12|-1.54|<0.0001
71099273|NCT02191397|141707285|OTHER||Mean Difference (Final Values)|0.4||||0.118|TWO_SIDED|95.0|-0.1|0.85||Analysis included Baseline HAMD-17 anxiety/somatization subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.85|-0.10|0.118
71099274|NCT02191397|141707285|OTHER||Mean Difference (Final Values)|0.3||||0.252|TWO_SIDED|95.0|-0.19|0.71||Analysis included Baseline HAMD-17 anxiety/somatization subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.71|-0.19|0.252
70994066|NCT01205451|141497043|SUPERIORITY_OR_OTHER||t-distribution|-0.88|||<|0.0001|TWO_SIDED|95.0|-1.04|-0.72||The P-value for change from Baseline indicates the comparision of the Week 12 value against the Baseline value.|Wilcoxon signed-rank test||Confidence intervals for means were based on the t-distribution.|||-0.72|-1.04|<0.0001
70994067|NCT01205451|141497043|SUPERIORITY_OR_OTHER||t-distribution|-1.12|||<|0.0001|TWO_SIDED|95.0|-1.33|-0.91||The P-value for change from Baseline indicates the comparision of the Week 12 value against the Baseline value.|Wilcoxon signed-rank test||Confidence intervals for means were based on the t-distribution.|||-0.91|-1.33|<0.0001
70994068|NCT03004469|141497088|OTHER||LS Mean Difference|13.6|STANDARD_ERROR_OF_MEAN|3.94|<|0.001|TWO_SIDED|95.0|5.8|21.3|||Mixed linear model|||||21.3|5.8|<.001
71099275|NCT02191397|141707286|OTHER||Mean Difference (Final Values)|0.1||||0.573|TWO_SIDED|95.0|-0.2|0.35||Analysis included Baseline HAMD-17 Retardation subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.35|-0.20|0.573
71099276|NCT02191397|141707286|OTHER||Mean Difference (Final Values)|0.2||||0.209|TWO_SIDED|95.0|-0.13|0.58||Analysis included Baseline HAMD-17 Retardation subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.58|-0.13|0.209
71099277|NCT02191397|141707286|OTHER||Mean Difference (Final Values)|0.2||||0.427|TWO_SIDED|95.0|-0.25|0.58||Analysis included Baseline HAMD-17 Retardation subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.58|-0.25|0.427
71099278|NCT02191397|141707286|OTHER||Mean Difference (Final Values)|0.0||||0.851|TWO_SIDED|95.0|-0.4|0.48||Analysis included Baseline HAMD-17 Retardation subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.48|-0.40|0.851
71099279|NCT02191397|141707286|OTHER||Mean Difference (Final Values)|0.2||||0.37|TWO_SIDED|95.0|-0.25|0.66||Analysis included Baseline HAMD-17 Retardation subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.66|-0.25|0.370
71099280|NCT02191397|141707287|OTHER||Mean Difference (Final Values)|0.1||||0.438|TWO_SIDED|95.0|-0.16|0.37||Analysis included Baseline HAMD-17 Sleep Disorder subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.37|-0.16|0.438
71099281|NCT02191397|141707287|OTHER||Mean Difference (Final Values)|0.4||||0.014|TWO_SIDED|95.0|0.07|0.66||Analysis included Baseline HAMD-17 Sleep Disorder subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.66|0.07|0.014
71099282|NCT02191397|141707287|OTHER||Mean Difference (Final Values)|0.2||||0.207|TWO_SIDED|95.0|-0.11|0.5||Analysis included Baseline HAMD-17 Sleep Disorder subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.50|-0.11|0.207
71099283|NCT02191397|141707287|OTHER||Mean Difference (Final Values)|0.2||||0.137|TWO_SIDED|95.0|-0.07|0.54||Analysis included Baseline HAMD-17 Sleep Disorder subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.54|-0.07|0.137
71099284|NCT02191397|141707287|OTHER||Mean Difference (Final Values)|0.2||||0.299|TWO_SIDED|95.0|-0.14|0.46||Analysis included Baseline HAMD-17 Sleep Disorder subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.46|-0.14|0.299
71099285|NCT02191397|141707288|OTHER||Mean Difference (Final Values)|0.0||||0.804|TWO_SIDED|95.0|-0.1|0.13||Analysis included Baseline CGI-S score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.13|-0.10|0.804
71099286|NCT02191397|141707288|OTHER||Mean Difference (Final Values)|0.1||||0.079|TWO_SIDED|95.0|-0.02|0.28||Analysis included Baseline CGI-S score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.28|-0.02|0.079
70994069|NCT03004469|141497089|OTHER||LS Mean Difference|12.8|STANDARD_ERROR_OF_MEAN|3.19|<|0.001|TWO_SIDED|95.0|6.5|19.1|||Mixed linear model|||||19.1|6.5|<.001
70994070|NCT03004469|141497090|OTHER||LS Mean Difference|-0.4024|STANDARD_ERROR_OF_MEAN|0.4057||0.322|TWO_SIDED|95.0|-1.202|0.3971|||Mixed linear model|||Statistical Analysis details presented here is for Week 12||0.3971|-1.2020|0.322
70994071|NCT03004469|141497090|OTHER||LS Mean Difference|0.7237|STANDARD_ERROR_OF_MEAN|0.47799||0.131|TWO_SIDED|95.0|-0.2184|1.6657|||Mixed linear model|||Statistical Analysis details presented here is for Week 24||1.6657|-0.2184|0.131
70994072|NCT03004469|141497091|OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.569|TWO_SIDED|95.0|-0.3|0.2|||Mixed linear model|||Statistical Analysis details presented here is for Week 12||0.2|-0.3|0.569
70994073|NCT03004469|141497091|OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.129|TWO_SIDED|95.0|-0.4|0.1|||Mixed linear model|||Statistical Analysis details presented here is for Week 24||0.1|-0.4|0.129
70994074|NCT03004469|141497092|OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.708|TWO_SIDED|95.0|-0.2|0.3|||Mixed linear model|||Statistical Analysis details presented here is for Week 12||0.3|-0.2|0.708
70994075|NCT03004469|141497092|OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|0.2|0.7|||Mixed linear model|||Statistical Analysis details presented here is for Week 24||0.7|0.2|<.001
70994076|NCT03004469|141497093|OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.179|TWO_SIDED|95.0|-0.3|0.1|||Mixed linear model|||Statistical Analysis details presented here is for Week 12||0.1|-0.3|0.179
70994077|NCT03004469|141497093|OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.262|TWO_SIDED|95.0|-0.1|0.4|||Mixed linear model|||Statistical Analysis details presented here is for Week 24||0.4|-0.1|0.262
70994078|NCT03004469|141497094|OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|1.03||0.103|TWO_SIDED|95.0|-3.7|0.3|||Mixed linear model|||Statistical Analysis details presented here is for Erectile Function Score, Week 4||0.3|-3.7|0.103
70994079|NCT03004469|141497094|OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.1||0.545|TWO_SIDED|95.0|-2.8|1.5|||Mixed linear model|||Statistical Analysis details presented here is for Erectile Function Score, Week 8||1.5|-2.8|0.545
70994080|NCT03004469|141497094|OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.0||0.842|TWO_SIDED|95.0|-2.2|1.8|||Mixed linear model|||Statistical Analysis details presented here is for Erectile Function Score, Week 12||1.8|-2.2|0.842
70994081|NCT03004469|141497094|OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.02||0.449|TWO_SIDED|95.0|-2.8|1.2|||Mixed linear model|||Statistical Analysis details presented here is for Erectile Function Score, Week 24||1.2|-2.8|0.449
70994082|NCT03004469|141497094|OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.28||0.272|TWO_SIDED|95.0|-0.2|0.9|||Mixed linear model|||Statistical Analysis details presented here is for Orgasmic Function Score, Week 4||0.9|-0.2|0.272
70994083|NCT03004469|141497094|OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.36||0.918|TWO_SIDED|95.0|-0.7|0.8|||Mixed linear model|||Statistical Analysis details presented here is for Orgasmic Function Score, Week 8||0.8|-0.7|0.918
70994084|NCT03004469|141497094|OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.078||0.078|TWO_SIDED|95.0|-0.1|1.1|||Mixed linear model|||Statistical Analysis details presented here is for Orgasmic Function Score, Week 12||1.1|-0.1|0.078
70994085|NCT03004469|141497094|OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.34||0.593|TWO_SIDED|95.0|-0.9|0.5|||Mixed linear model|||Statistical Analysis details presented here is for Orgasmic Function Score, Week 24||0.5|-0.9|0.593
71040006|NCT02377349|141587891|SUPERIORITY|Criterion: The lower limit (LL) of the 95% confidence interval (CI) of the GMC ratio \[dTpa Group-Mother/Control Group-Mother\] for anti-PRN antibodies was greater than or equal to (≥) 1.5.|GMC ratio|20.65|||||TWO_SIDED|95.0|15.86|26.88|||2-sample t-test|The CI of the group GMC ratio were computed using two-sample t-test assuming heterogeneity of variance.||GMC ratio between groups (dTpa Group-Mother/Control Group-Mother) to demonstrate that maternally transferred antibodies against pertussis in the dTpa Group-Mother was superior to that in the Control Group-mother, in the cord blood sample at the time of delivery.||26.88|15.86|
71040007|NCT00550147|141587918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.125|STANDARD_ERROR_OF_MEAN|0.1933|<|0.05|TWO_SIDED|95.0|-1.52|-0.72|||t-test, 2 sided|Paired t-test (comparing augmentation period start score with end score), 23 df. Value is Visit 10 score minus Visit 5 score (null hypothesis=0).|This was a comparison of pre-post change in a single group, with treatment administered open-label.|This was a repeated-measures analysis, using a single group of subjects who were administered quetiapine in addition to OROS mph. See Kronenberger et al. (2007, Journal of Child and Adolescent Psychopharmacology) for additional information.||-0.72|-1.52|<0.05
71040008|NCT00550147|141587919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.2056|<|0.05||95.0|-1.75|-0.91|||t-test, 2 sided|Paired t-test (comparing augmentation period start score with end score), 23 df. Value is Visit 10 score minus Visit 5 score (null hypothesis=0).|This was a comparison of pre-post change in a single group, with treatment administered open-label.|This was a repeated-measures analysis, using a single group of subjects who were administered quetiapine in addition to OROS mph. Results reported here are for the augmentation period (Visit 5-10). See Kronenberger et al. (2007, Journal of Child and Adolescent Psychopharmacology) for additional information.||-0.91|-1.75|<0.05
70994086|NCT03004469|141497094|OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.23||0.295|TWO_SIDED|95.0|-0.7|0.2|||Mixed linear model|||Statistical Analysis details presented here is for Sexual Desire Score, Week 4||0.2|-0.7|0.295
70994087|NCT03004469|141497094|OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.22||0.926|TWO_SIDED|95.0|-0.5|0.4|||Mixed linear model|||Statistical Analysis details presented here is for Sexual Desire Score, Week 8||0.4|-0.5|0.926
70994088|NCT03004469|141497094|OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.183|TWO_SIDED|95.0|-0.7|0.1|||Mixed linear model|||Statistical Analysis details presented here is for Sexual Desire Score, Week 12||0.1|-0.7|0.183
70994089|NCT03004469|141497094|OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.23||0.981|TWO_SIDED|95.0|-0.4|0.5|||Mixed linear model|||Statistical Analysis details presented here is for Sexual Desire Score, Week 24||0.5|-0.4|0.981
70994090|NCT03004469|141497094|OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.66||0.041|TWO_SIDED|95.0|-2.7|-0.1|||Mixed linear model|||Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 4||-0.1|-2.7|0.041
70994091|NCT03004469|141497094|OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.67||0.562|TWO_SIDED|95.0|-1.7|0.9|||Mixed linear model|||Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 8||0.9|-1.7|0.562
70994092|NCT03004469|141497094|OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.66||0.642|TWO_SIDED|95.0|-1.6|1.0|||Mixed linear model|||Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 12||1.0|-1.6|0.642
70994093|NCT03004469|141497094|OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.65||0.156|TWO_SIDED|95.0|-2.2|0.4|||Mixed linear model|||Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 24||0.4|-2.2|0.156
71040009|NCT00550147|141587920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.3|STANDARD_ERROR_OF_MEAN|13.06|<|0.05||95.0|-74.3|-20.2|||t-test, 2 sided|Paired t-test (comparing augmentation period start score with end score), 23 df. Value is Visit 10 score minus Visit 5 score (null hypothesis=0).|This was a comparison of pre-post change in a single group, with treatment administered open-label.|This was a repeated-measures analysis, using a single group of subjects who were administered quetiapine in addition to OROS mph. Results reported here are for the augmentation period (Visit 5-10). See Kronenberger et al. (2007, Journal of Child and Adolescent Psychopharmacology) for additional information.||-20.2|-74.3|<0.05
70994094|NCT03004469|141497094|OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.29||0.824|TWO_SIDED|95.0|-0.6|0.5|||Mixed linear model|||Statistical Analysis details presented here is for Overall Satisfaction Score, Week 4||0.5|-0.6|0.824
71040010|NCT00550147|141587921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.17|STANDARD_ERROR_OF_MEAN|1.39|<|0.05|TWO_SIDED|95.0|-7.04|-1.29|||t-test, 2 sided|Paired t-test (comparing augmentation period start score with end score), 23 df. Value is Visit 10 score minus Visit 5 score (null hypothesis=0).|This was a comparison of pre-post change in a single group, with treatment administered open-label.|This was a repeated-measures analysis, using a single group of subjects who were administered quetiapine in addition to OROS mph. Results reported here are for the augmentation period (Visit 5-10). See Kronenberger et al. (2007, Journal of Child and Adolescent Psychopharmacology) for additional information.||-1.29|-7.04|<0.05
71040011|NCT00550147|141587922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.29|STANDARD_ERROR_OF_MEAN|2.16|<|0.05||95.0|-17.76|-8.82|||t-test, 2 sided|Paired t-test (comparing augmentation period start score with end score), 23 df. Value is Visit 10 score minus Visit 5 score (null hypothesis=0).|This was a comparison of pre-post change in a single group, with treatment administered open-label.|This was a repeated-measures analysis, using a single group of subjects who were administered quetiapine in addition to OROS mph. Results reported here are for the augmentation period (Visit 5-10). See Kronenberger et al. (2007, Journal of Child and Adolescent Psychopharmacology) for additional information.||-8.82|-17.76|<0.05
71040012|NCT01567527|141587925|SUPERIORITY||Hazard Ratio (HR)|0.451|||<|0.0001|TWO_SIDED|95.0|0.299|0.678|||Log Rank||"Using the Cox proportional hazards model with term for treatment group.~HR is estimated for Aripiprazole IM depot relative to Placebo."|Significance level 0.05.||0.678|0.299|< 0.0001
71040013|NCT01567527|141587925|SUPERIORITY|Using the Cox proportional hazards model with term for treatment group.|Hazard Ratio (HR)|2.22|||||TWO_SIDED|95.0|1.475|3.34|||||HR is estimated for Placebo relative to Aripiprazole IM depot.|||3.34|1.475|
71040014|NCT01567527|141587926|SUPERIORITY|Using a hierarchical procedure to preserve the overall Type I error rate at 0.05, after testing the primary outcome.|Percentage Difference (Final Values)|-24.6|||<|0.0001|TWO_SIDED|95.0|-36.7|-12.5|||Fisher Exact|||Statistical analysis for any mood episode||-12.5|-36.7|< 0.0001
70994095|NCT03004469|141497094|OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.29||0.713|TWO_SIDED|95.0|-0.5|0.7|||Mixed linear model|||Statistical Analysis details presented here is for Overall Satisfaction Score, Week 8||0.7|-0.5|0.713
70994096|NCT03004469|141497094|OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.993|TWO_SIDED|95.0|-0.6|0.6|||Mixed linear model|||Statistical Analysis details presented here is for Overall Satisfaction Score, Week 12||0.6|-0.6|0.993
71040015|NCT01567527|141587927|SUPERIORITY|Using mixed model repeated measures (MMRM) analysis with a restricted maximum likelihood (REML) approach. Analyses included the categorically fixed effects of treatment, region, trial week, and treatment-by-week interaction, as well as the continuously fixed covariates of baseline-score-by-week interaction. An unstructured covariance structure was used to model the within-subject errors and Kenward-Rodger degree of freedom was used to test the fixed effects.|Mean Difference (Final Values)|-0.43|||=|0.0011|TWO_SIDED|95.0|-0.69|-0.17|||Mixed model repeated measure analysis|||||-0.17|-0.69|= 0.0011
71099287|NCT02191397|141707288|OTHER||Mean Difference (Final Values)|0.2||||0.036|TWO_SIDED|95.0|0.01|0.38||Analysis included Baseline CGI-S score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.38|0.01|0.036
71040016|NCT01567527|141587928|SUPERIORITY||Hazard Ratio (HR)|0.137|||=|0.0002|TWO_SIDED|95.0|0.04|0.465|||Log Rank||"Using the Cox proportional hazards model with term for treatment group.~HR is estimated for Aripiprazole IM depot relative to Placebo."|||0.465|0.04|= 0.0002
71040017|NCT01567527|141587928|SUPERIORITY|Using the Cox proportional hazards model with term for treatment group.|Hazard Ratio (HR)|7.313|||||TWO_SIDED|95.0|2.151|24.865|||||HR is estimated for Placebo relative to Aripiprazole IM depot.|||24.865|2.151|
70994097|NCT03004469|141497094|OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.55|TWO_SIDED|95.0|-0.8|0.4|||Mixed linear model|||Statistical Analysis details presented here is for Overall Satisfaction Score, Week 24||0.4|-0.8|0.550
70994098|NCT04511819|141497123|OTHER||Risk Difference (RD)|-0.087||||0.8762|TWO_SIDED|95.0|-0.347|0.174|||Regression, Logistic|||||0.174|-0.347|0.8762
70994099|NCT01940510|141497129|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|26.8|||||TWO_SIDED|90.0|23.8|30.1|||||The reported values are percentages of geometric least square mean ratio.|Analysis of variance (ANOVA) was applied to the log-transformed PK parameters, and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and confidence intervals.||30.1|23.8|
71040018|NCT00936351|141587951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.21||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||.04
71040019|NCT03828539|141587955|OTHER||Odds Ratio (OR)|0.19|||<|0.001|TWO_SIDED|95.0|0.13|0.27|||Regression, Logistic|Odds ratio is obtained from a logistic regression model that includes treatment group and stratification factor (MMD at baseline)||||0.27|0.13|<.001
71040020|NCT03828539|141587956|OTHER||Odds Ratio (OR)|2.76|||<|0.001|TWO_SIDED|95.0|2.06|3.71|||Regression, Logistic|Odds ratio is obtained from a logistic regression model that includes treatment group and stratification factor (MMD at baseline)||||3.71|2.06|<.001
71040021|NCT03828539|141587957|OTHER||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.7|3.12|||Regression, Logistic|Odds ratio is obtained from a logistic regression model that includes treatment group and stratification factor (MMD at baseline)||||3.12|1.70|<.001
70994100|NCT01940510|141497130|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|48.6|||||TWO_SIDED|90.0|43.5|54.3|||||ANOVA was applied to the log-transformed PK parameters, and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and confidence intervals. The reported values are percentages of geometric least square mean ratio.|||54.3|43.5|
70994101|NCT01940510|141497131|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|179.0|||||TWO_SIDED|90.0|158.0|202.0|||||ANOVA was applied to the log-transformed PK parameters, and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and confidence intervals. The reported values are percentages of geometric least square mean ratio.|||202|158|
70994102|NCT01940510|141497132|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|220.0|||||TWO_SIDED|90.0|190.0|255.0|||||ANOVA was applied to the log-transformed PK parameters, and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and confidence intervals. The reported values are percentages of geometric least square mean ratio.|||255|190|
70994103|NCT00844649|141497144|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72|||<|0.0001|TWO_SIDED|95.0|0.617|0.835||P-value was based on a stratified log-rank test stratified by randomization strata of geographic region (North America versus Others), Karnofsky performance score (70 to 80 versus 90 to 100), and presence of liver metastasis|Stratified Log-rank Test||Hazard ratio of Albumin bound paclitaxel + gemcitabine/gemcitabine alone. The associated hazard ratio and two-sided 95% confidence interval were estimated using a stratified Cox proportional hazard model.|||0.835|0.617|<0.0001
70994104|NCT00844649|141497145|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.581|0.821||P-value was based on a stratified log-rank test by randomization strata of geographic region (North America versus Others), Karnofsky performance score (70 to 80 versus 90 to 100), and presence of liver metastasis (yes vs no)|Stratified Log-rank Test||Hazard ratio of Albumin bound paclitaxel + gemcitabine / gemcitabine alone. The associated hazard ratio and two-sided 95% confidence interval were estimated using a stratified Cox proportional hazard model.|||0.821|0.581|<0.0001
71040022|NCT03828539|141587958|OTHER||Odds Ratio (OR)|1.75|||<|0.001|TWO_SIDED|95.0|1.26|2.43|||Regression, Logistic|Odds ratio is obtained from a logistic regression model that includes treatment group and stratification factor (MMD at baseline)||Physical Component Summary (PCS)||2.43|1.26|<0.001
71040023|NCT03828539|141587958|OTHER||Odds Ratio (OR)|1.79||||0.005|TWO_SIDED|95.0|1.29|2.69|||Regression, Logistic|Odds ratio is obtained from a logistic regression model that includes treatment group and stratification factor (MMD at baseline)||Mental Component Summary (MCS)||2.69|1.29|0.005
71040024|NCT02616380|141587963|OTHER||||||<|0.0001|||||||Paired t-test|The mean change was tested with a paired t-test without adjusting for baseline disease severity.||||||<0.0001
71040025|NCT02616380|141587964|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Physical Component Score at Week 12||||<0.0001
71040026|NCT02616380|141587964|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Physical Component Score at Week 24||||<0.0001
70994105|NCT00844649|141497146|SUPERIORITY_OR_OTHER_LEGACY||Response Rate Ratio|3.19|||<|0.0001|TWO_SIDED|95.0|2.178|4.662|||Chi-squared||Response rate ratio: albumin-bound paclitaxel + gemcitabine /gemcitabine alone|PA+G/PG = response rate ratio of albumin bound paclitaxel + gemcitabine / gemcitabine.||4.662|2.178|<0.0001
70994106|NCT00424294|141497151|SUPERIORITY_OR_OTHER|||||||0.733|TWO_SIDED||||||Chi-squared|||||||0.733
70994107|NCT00424294|141497152|SUPERIORITY_OR_OTHER|||||||0.463|TWO_SIDED||||||Chi-squared|||Week 1: p-value was calculated by Chi-square test.||||0.463
70994108|NCT00424294|141497152|SUPERIORITY_OR_OTHER|||||||0.549|TWO_SIDED||||||Chi-squared|||Week 2: p-value was calculated by Chi-square test.||||0.549
70994109|NCT00424294|141497152|SUPERIORITY_OR_OTHER|||||||0.272|TWO_SIDED||||||Chi-squared|||Week 4: p-value was calculated by Chi-square test.||||0.272
70994110|NCT00424294|141497152|SUPERIORITY_OR_OTHER|||||||0.265|TWO_SIDED||||||Chi-squared|||Week 8: p-value was calculated by Chi-square test.||||0.265
70994111|NCT00424294|141497153|SUPERIORITY_OR_OTHER|||||||0.939|TWO_SIDED||||||Fisher Exact|||Week 4: p-value was calculated by Fisher exact test.||||0.939
70994112|NCT00424294|141497153|SUPERIORITY_OR_OTHER|||||||0.323|TWO_SIDED||||||Fisher Exact|||Week 8: p-value was calculated by Fisher exact test.||||0.323
70994113|NCT00424294|141497153|SUPERIORITY_OR_OTHER|||||||0.338|TWO_SIDED||||||Fisher Exact|||Week 12: p-value was calculated by Fisher exact test.||||0.338
70994114|NCT00424294|141497154|SUPERIORITY_OR_OTHER|||||||0.746|TWO_SIDED||||||Fisher Exact|||Week 12: p-value was calculated by Fisher exact test.||||0.746
70994115|NCT00424294|141497155|SUPERIORITY_OR_OTHER|||||||0.635|TWO_SIDED||||||ANCOVA|||Week 1: Analysis of covariance (ANCOVA) with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.635
70994116|NCT00424294|141497155|SUPERIORITY_OR_OTHER|||||||0.044|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.044
70994117|NCT00424294|141497155|SUPERIORITY_OR_OTHER|||||||0.957|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.957
70994118|NCT00424294|141497155|SUPERIORITY_OR_OTHER|||||||0.597|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.597
71040027|NCT02616380|141587964|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Mental Component Score at Week 12||||<0.0001
71040028|NCT02616380|141587964|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Mental Component Score at Week 24||||<0.0001
71040029|NCT02616380|141587965|OTHER||||||<|0.0001|||||||Paired t-test|||Change from Baseline in EQ-5D-3L at 12 weeks||||<0.0001
71040030|NCT02616380|141587965|OTHER||||||<|0.0001|||||||Paired t-test|||Change from Baseline in EQ-5D-3L at 24 weeks||||<0.0001
71040031|NCT02616380|141587966|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Overall Work Impairment at Week 12||||<0.0001
71040032|NCT02616380|141587966|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Overall Work Impairment at Week 24||||<0.0001
71040033|NCT02616380|141587966|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Activity Impairment at Week 12||||<0.0001
70994119|NCT00424294|141497155|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.960
70994120|NCT00424294|141497156|SUPERIORITY_OR_OTHER|||||||0.252|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.252
70994121|NCT00424294|141497156|SUPERIORITY_OR_OTHER|||||||0.032|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.032
70994122|NCT00424294|141497156|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.031
70994123|NCT00424294|141497156|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.018
70994124|NCT00424294|141497156|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.170
70994125|NCT00424294|141497157|SUPERIORITY_OR_OTHER|||||||0.507|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.507
70994126|NCT00424294|141497157|SUPERIORITY_OR_OTHER|||||||0.743|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.743
70994127|NCT00424294|141497157|SUPERIORITY_OR_OTHER|||||||0.914|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.914
70994128|NCT00424294|141497157|SUPERIORITY_OR_OTHER|||||||0.715|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.715
70994129|NCT00424294|141497157|SUPERIORITY_OR_OTHER|||||||0.558|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.558
70994130|NCT00424294|141497158|SUPERIORITY_OR_OTHER|||||||0.172|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.172
70994131|NCT00424294|141497158|SUPERIORITY_OR_OTHER|||||||0.738|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.738
70994132|NCT00424294|141497158|SUPERIORITY_OR_OTHER|||||||0.948|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.948
71040034|NCT02616380|141587966|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Activity Impairment at Week 24||||<0.0001
70994133|NCT00424294|141497158|SUPERIORITY_OR_OTHER|||||||0.428|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.428
70994134|NCT00424294|141497158|SUPERIORITY_OR_OTHER|||||||0.861|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.861
70994135|NCT00424294|141497159|SUPERIORITY_OR_OTHER|||||||0.325|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.325
70994136|NCT00424294|141497159|SUPERIORITY_OR_OTHER|||||||0.386|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.386
70994137|NCT00424294|141497159|SUPERIORITY_OR_OTHER|||||||0.532|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.532
70994138|NCT00424294|141497159|SUPERIORITY_OR_OTHER|||||||0.909|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.909
70994139|NCT00424294|141497159|SUPERIORITY_OR_OTHER|||||||0.994|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.994
70994140|NCT00424294|141497160|SUPERIORITY_OR_OTHER|||||||0.369|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.369
70994141|NCT00424294|141497160|SUPERIORITY_OR_OTHER|||||||0.666|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.666
70994142|NCT00424294|141497160|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.530
71040035|NCT02616380|141587967|OTHER||||||<|0.0001|||||||Paired t-test|The mean change was tested with a paired t-test without adjusting for baseline disease severity.||||||<0.0001
70994143|NCT00424294|141497160|SUPERIORITY_OR_OTHER|||||||0.632|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.632
71099288|NCT02191397|141707288|OTHER||Mean Difference (Final Values)|0.1||||0.248|TWO_SIDED|95.0|-0.08|0.31||Analysis included Baseline CGI-S score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.31|-0.08|0.248
71099289|NCT02191397|141707288|OTHER||Mean Difference (Final Values)|0.2||||0.11|TWO_SIDED|95.0|-0.04|0.35||Analysis included Baseline CGI-S score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.35|-0.04|0.110
71099290|NCT02191397|141707289|OTHER||Odds Ratio, log|0.78||||0.545|TWO_SIDED|95.0|0.35|1.75||P-value was estimated from a GEE model repeated measures with CGI-I score of 1 or 2 as response variable and treatment, gender as explanatory variables|GEE model repeated measures||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||1.75|0.35|0.545
71099291|NCT02191397|141707289|OTHER||Odds Ratio (OR)|0.95||||0.822|TWO_SIDED|95.0|0.58|1.54||P-value was estimated from a GEE model repeated measures with CGI-I score of 1 or 2 as response variable and treatment, gender as explanatory variables|GEE model repeated measures||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||1.54|0.58|0.822
70994144|NCT00424294|141497160|SUPERIORITY_OR_OTHER|||||||0.801|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.801
71099292|NCT02191397|141707289|OTHER||Odds Ratio (OR)|0.57||||0.007|TWO_SIDED|95.0|0.38|0.86||P-value was estimated from a GEE model repeated measures with CGI-I score of 1 or 2 as response variable and treatment, gender as explanatory variables|GEE model repeated measures||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.86|0.38|0.007
71099293|NCT02191397|141707289|OTHER||Odds Ratio (OR)|0.83||||0.417|TWO_SIDED|95.0|0.54|1.29||P-value was estimated from a GEE model repeated measures with CGI-I score of 1 or 2 as response variable and treatment, gender as explanatory variables|GEE model repeated measures||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||1.29|0.54|0.417
71099294|NCT02191397|141707289|OTHER||Odds Ratio (OR)|0.83||||0.485|TWO_SIDED|95.0|0.49|1.4||P-value was estimated from a GEE model repeated measures with CGI-I score of 1 or 2 as response variable and treatment, gender as explanatory variables|GEE model repeated measures||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||1.40|0.49|0.485
71099295|NCT01618708|141707368|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean difference|0.07|||=|0.7462|TWO_SIDED|95.0|-0.38|0.52||Threshold for significance at 0.05 level|Mixed Models Analysis||Placebo vs Synvisc-One|Synvisc-One group was compared to placebo group using mixed model for repeated measures (MMRM) approach assuming missing data at random (MAR).||0.52|-0.38|= 0.7462
71099296|NCT02554474|141707377|SUPERIORITY||Adjusted difference in mean change|9.4|||||TWO_SIDED|95.0|-0.5|19.3||||||We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing time in MVPA at 9 weeks (primary end point) between groups, adjusting for baseline MVPA, diagnosis, and blocking.||19.3|-0.5|
71099297|NCT02554474|141707378|SUPERIORITY||Adjusted difference in mean change|-10.4|||||TWO_SIDED|95.0|-53.4|32.6||||||We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing sedentary time at 9 weeks (primary end point) between groups, adjusting for baseline sedentary time, diagnosis, and blocking.||32.6|-53.4|
71099298|NCT02554474|141707379|SUPERIORITY||Adjusted difference in mean change|-0.31|||||TWO_SIDED|95.0|-0.63|0.01||||||We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing time in the Fatigue Severity Scale at 9 weeks (primary end point) between groups, adjusting for baseline fatigue score, diagnosis, and blocking.||0.01|-0.63|
71099299|NCT02554474|141707380|SUPERIORITY||Adjusted difference in mean change|-2.45|||||TWO_SIDED|95.0|-4.78|-0.13||||||We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing pain at 9 weeks (primary end point) between groups, adjusting for pain score, diagnosis, and blocking.||-0.13|-4.78|
70994145|NCT00424294|141497161|SUPERIORITY_OR_OTHER|||||||0.052|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.052
70994146|NCT00424294|141497161|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.108
70994147|NCT00424294|141497161|SUPERIORITY_OR_OTHER|||||||0.573|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.573
70994148|NCT00424294|141497161|SUPERIORITY_OR_OTHER|||||||0.342|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.342
70994149|NCT00424294|141497161|SUPERIORITY_OR_OTHER|||||||0.501|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.501
70994150|NCT00424294|141497162|SUPERIORITY_OR_OTHER|||||||0.701|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.701
70994151|NCT00424294|141497162|SUPERIORITY_OR_OTHER|||||||0.167|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.167
70994152|NCT00424294|141497162|SUPERIORITY_OR_OTHER|||||||0.948|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.948
71099300|NCT02554474|141707381|SUPERIORITY||Adjusted difference in mean change|-0.22|||||TWO_SIDED|95.0|-1.78|1.35||||||We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing the PHQ-9 scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking.||1.35|-1.78|
70994153|NCT00424294|141497162|SUPERIORITY_OR_OTHER|||||||0.834|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.834
70994154|NCT00424294|141497162|SUPERIORITY_OR_OTHER|||||||0.977|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.977
70994155|NCT00424294|141497163|SUPERIORITY_OR_OTHER|||||||0.291|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.291
70994156|NCT00424294|141497163|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.080
70994157|NCT00424294|141497163|SUPERIORITY_OR_OTHER|||||||0.466|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.466
70994158|NCT00424294|141497163|SUPERIORITY_OR_OTHER|||||||0.267|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.267
70994159|NCT00424294|141497163|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.100
70994160|NCT04397718|141497173|SUPERIORITY||Odds Ratio (OR)|1.19||||0.667|TWO_SIDED|95.0|0.46|3.06|||Chi-squared||Logistic regression adjusted for age, hypertension, and COPD|||3.06|0.46|0.667
70994161|NCT04397718|141497174|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.876|TWO_SIDED|95.0|0.58|1.49|||Log Rank||Cox regression model adjusted for age, hypertension, and COPD.|||1.49|0.58|0.876
70994162|NCT04397718|141497175|SUPERIORITY||Odds Ratio (OR)|0.95||||0.991|TWO_SIDED|95.0|0.31|2.92|||Chi-squared||Logistic regression adjusted for age, hypertension, and COPD.|||2.92|0.31|0.991
70994163|NCT04397718|141497176|SUPERIORITY||Quantile Regression|0.0||||0.841|TWO_SIDED|95.0|-2.03|4.11|||Wilcoxon (Mann-Whitney)||Adjusted for age, hypertension, and COPD|||4.11|-2.03|0.841
70994164|NCT04397718|141497177|SUPERIORITY||Quantile Regression|0.0||||0.746|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)||Adjusted for age, hypertension, and COPD|||0|0|0.746
70994165|NCT04397718|141497178|SUPERIORITY||Hazard Ratio (HR)|2.3||||0.1|TWO_SIDED|95.0|0.72|7.39|||Log Rank||Cox regression model adjusted for age, hypertension, and COPD|||7.39|0.72|0.1
70994166|NCT04397718|141497179|SUPERIORITY||Odds Ratio (OR)|0.82||||0.425|TWO_SIDED|95.0|0.33|2.0|||Fisher Exact||||Logistical regression adjusted for age, hypertension, COPD, and baseline severity score.|2|0.33|0.425
70994167|NCT04397718|141497180|SUPERIORITY||Odds Ratio (OR)|1.22||||0.688|TWO_SIDED|95.0|0.44|3.42|||Chi-squared||Logistic regression adjusted for age, hypertension, and COPD.|||3.42|0.44|0.688
70994168|NCT01797965|141497197|SUPERIORITY|||||||0.5937|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 12||||0.5937
70994169|NCT01797965|141497197|SUPERIORITY|||||||0.6233|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 24||||0.6233
70994170|NCT01797965|141497197|SUPERIORITY|||||||0.1884|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 48||||0.1884
70994171|NCT01797965|141497198|SUPERIORITY|||||||0.0204|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 12 for 301||||0.0204
70994172|NCT01797965|141497198|SUPERIORITY|||||||0.0805|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 24 for 301||||0.0805
70994173|NCT01797965|141497198|SUPERIORITY|||||||0.2535|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 36 for 301||||0.2535
70994174|NCT01797965|141497198|SUPERIORITY|||||||0.4738|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 48 for 301||||0.4738
70994175|NCT01797965|141497198|SUPERIORITY|||||||0.2302|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 60 for 301||||0.2302
70994176|NCT01797965|141497198|SUPERIORITY|||||||0.8522|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 72 for 301||||0.8522
70994177|NCT01797965|141497198|SUPERIORITY|||||||0.0431|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 84 for 301||||0.0431
70994178|NCT01797965|141497198|SUPERIORITY|||||||0.0339|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 96 for 301||||0.0339
70994179|NCT01797965|141497198|SUPERIORITY|||||||0.3195|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 108 for 301||||0.3195
70994180|NCT01797965|141497198|SUPERIORITY|||||||0.2119|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 120 for 301||||0.2119
70994181|NCT01797965|141497198|SUPERIORITY|||||||0.3619|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 132 for 301||||0.3619
70994182|NCT01797965|141497198|SUPERIORITY|||||||0.017|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 144 for 301||||0.0170
70994183|NCT01797965|141497198|SUPERIORITY|||||||0.017|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Baseline 303||||0.0170
70994184|NCT01797965|141497198|SUPERIORITY|||||||0.0849|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 12 for 303||||0.0849
70994185|NCT01797965|141497198|SUPERIORITY|||||||0.0057|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 24 for 303||||0.0057
70994186|NCT01797965|141497198|SUPERIORITY|||||||0.396|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 48 for 303||||0.3960
70994187|NCT01797965|141497200|SUPERIORITY||Odds Ratio (OR)|0.902||||0.8417|TWO_SIDED|95.0|0.329|2.473|||Regression, Logistic|Adjusted for the baseline relapse rate, history of prior IFN beta use (yes/no), baseline EDSS (\<=2.5 vs \>2.5) and baseline age (\<=35 vs \>35).||||2.473|0.329|0.8417
70994188|NCT01797965|141497222|SUPERIORITY|||||||0.3813|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 12||||0.3813
70994189|NCT01797965|141497222|SUPERIORITY|||||||0.1679|||||||ANOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 24||||0.1679
70994190|NCT01797965|141497222|SUPERIORITY|||||||0.5634|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 48||||0.5634
70994191|NCT01797965|141497222|SUPERIORITY|||||||0.7003|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 144||||0.7003
70994192|NCT01797965|141497222|SUPERIORITY|||||||0.7812|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 168||||0.7812
70994193|NCT01797965|141497222|SUPERIORITY|||||||0.3246|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 192||||0.3246
70994194|NCT01797965|141497222|SUPERIORITY|||||||0.6423|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 216||||0.6423
70994195|NCT01797965|141497222|SUPERIORITY|||||||0.0288|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 240||||0.0288
70994196|NCT01797965|141497223|SUPERIORITY|||||||0.2567|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 12 for 301||||0.2567
70994197|NCT01797965|141497223|SUPERIORITY|||||||0.6152|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 24 for 301||||0.6152
70994198|NCT01797965|141497223|SUPERIORITY|||||||0.2024|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 36 for 301||||0.2024
70994199|NCT01797965|141497223|SUPERIORITY|||||||0.9988|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 48 for 301||||0.9988
70994200|NCT01797965|141497223|SUPERIORITY|||||||0.7962|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 60 for 301||||0.7962
70994201|NCT01797965|141497223|SUPERIORITY|||||||0.8486|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 72 for 301||||0.8486
70994202|NCT01797965|141497223|SUPERIORITY|||||||0.4478|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 84 for 301||||0.4478
70994203|NCT01797965|141497223|SUPERIORITY|||||||0.325|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 96 for 301||||0.3250
70994204|NCT01797965|141497223|SUPERIORITY|||||||0.129|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 108 for 301||||0.1290
70994205|NCT01797965|141497223|SUPERIORITY|||||||0.7295|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 120 for 301||||0.7295
70994206|NCT01797965|141497223|SUPERIORITY|||||||0.8647|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 132 for 301||||0.8647
70994207|NCT01797965|141497223|SUPERIORITY|||||||0.2183|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 144 for 301||||0.2183
70994208|NCT01797965|141497223|SUPERIORITY|||||||0.3945|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Baseline 303||||0.3945
70994209|NCT01797965|141497223|SUPERIORITY|||||||0.5068|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 12 for 303||||0.5068
70994210|NCT01797965|141497223|SUPERIORITY|||||||0.1669|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 24 for 303||||0.1669
70994211|NCT01797965|141497223|SUPERIORITY|||||||0.5038|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 48 for 303||||0.5038
70994212|NCT01797965|141497223|SUPERIORITY|||||||0.6001|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 144 for 303||||0.6001
70994213|NCT01797965|141497223|SUPERIORITY|||||||0.8617|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 168 for 303||||0.8617
70994214|NCT01797965|141497223|SUPERIORITY|||||||0.259|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 192 for 303||||0.2590
70994215|NCT01797965|141497223|SUPERIORITY|||||||0.5159|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 216 for 303||||0.5159
70994216|NCT01797965|141497223|SUPERIORITY|||||||0.6123|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 240 for 303||||0.6123
71040036|NCT03950674|141587986|OTHER||Hazard Ratio (HR)|0.62||||0.12511|TWO_SIDED|95.0|0.27|1.42||One-sided p-value based on unstratified log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate stratified by PD-L1 status (≥1% vs. \<1%), platinum chemotherapy (cisplatin vs. carboplatin) \& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.|||1.42|0.27|0.12511
71040037|NCT03950674|141587987|OTHER||Hazard Ratio (HR)|0.29||||0.03127|TWO_SIDED|95.0|0.07|1.15||One-sided p-value based on unstratified log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate stratified by PD-L1 status (≥1% vs. \<1%), platinum chemotherapy (cisplatin vs. carboplatin) \& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.|||1.15|0.07|0.03127
71040038|NCT00830167|141587995|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.17||0.0046|TWO_SIDED|95.0|-0.78|-0.11||The analysis was conducted using 1-sided test with the significance level of 0.025. Actual significance level was calculated based on O'Brien-Fleming type alpha spending function of Lan and DeMets (1983).|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.11|-0.78|0.0046
71040039|NCT00830167|141587996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0078|TWO_SIDED|||||The analysis was conducted using 2-sided test with the significance level of 0.05.|Chi-squared|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that there was a difference between the pregabalin and the placebo groups.||||0.0078
70994217|NCT00304915|141497227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.003|TWO_SIDED|95.0|1.37|4.56|||Regression, Logistic|||||4.56|1.37|0.003
70994218|NCT01021852|141497233|SUPERIORITY_OR_OTHER||Difference in LS Means|8.4|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|95.0|5.3|11.5|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||11.5|5.3|<0.001
71040040|NCT00830167|141587997|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.48|STANDARD_ERROR_OF_MEAN|1.85|<|0.0001|TWO_SIDED|95.0|-13.12|-5.85||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-5.85|-13.12|<0.0001
71040041|NCT00830167|141587998|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.98|STANDARD_ERROR_OF_MEAN|1.88||0.9958|TWO_SIDED|95.0|1.29|8.68||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||8.68|1.29|0.9958
71040042|NCT00830167|141587999|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.99|STANDARD_ERROR_OF_MEAN|1.92||0.0049|TWO_SIDED|95.0|-8.77|-1.21||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-1.21|-8.77|0.0049
71040043|NCT00830167|141588000|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.09||0.0007|TWO_SIDED|95.0|0.11|0.47||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.47|0.11|0.0007
70994219|NCT01021852|141497233|SUPERIORITY_OR_OTHER||Difference in LS Means|9.9|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|95.0|6.8|13.1|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||13.1|6.8|<0.001
70994220|NCT01021852|141497233|SUPERIORITY_OR_OTHER||Difference in LS Means|10.7|STANDARD_ERROR_OF_MEAN|1.57|<|0.001|TWO_SIDED|95.0|7.7|13.8|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||13.8|7.7|<0.001
70994221|NCT01021852|141497233|SUPERIORITY_OR_OTHER||Difference in LS Means|13.4|STANDARD_ERROR_OF_MEAN|1.57|<|0.001|TWO_SIDED|95.0|10.3|16.5|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||16.5|10.3|<0.001
71040044|NCT00830167|141588001|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.48|STANDARD_ERROR_OF_MEAN|1.99|<|0.0001|TWO_SIDED|95.0|3.58|11.38||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||11.38|3.58|<0.0001
71040045|NCT00830167|141588002|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.31|STANDARD_ERROR_OF_MEAN|1.82||1|TWO_SIDED|95.0|7.74|14.87||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||14.87|7.74|1.0000
71040046|NCT00830167|141588003|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.99|STANDARD_ERROR_OF_MEAN|1.35||0.0137|TWO_SIDED|95.0|-5.65|-0.33||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.33|-5.65|0.0137
70994222|NCT01021852|141497233|SUPERIORITY_OR_OTHER||Difference in LS Means|4.6|STANDARD_ERROR_OF_MEAN|1.42||0.001|TWO_SIDED|95.0|1.8|7.4|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||7.4|1.8|0.001
71040047|NCT00830167|141588004|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.45||||0.0687|TWO_SIDED|95.0|0.9|2.35||The analysis was conducted using 1-sided test with the significance level of 0.025.|Regression, Logistic|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||2.35|0.90|0.0687
71040048|NCT00830167|141588005|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.06|-0.4||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.40|-1.06|<0.0001
71040049|NCT00830167|141588006|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.33|STANDARD_ERROR_OF_MEAN|1.52||0.0144|TWO_SIDED|95.0|-6.31|-0.35||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.35|-6.31|0.0144
71040050|NCT00830167|141588007|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.16||0.0376|TWO_SIDED|95.0|-0.59|0.03||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.03|-0.59|0.0376
71040051|NCT00830167|141588008|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.25||0.0052|TWO_SIDED|95.0|-1.12|-0.15||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.15|-1.12|0.0052
71040052|NCT00830167|141588009|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.21||0.4768|TWO_SIDED|95.0|-0.42|0.4||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.40|-0.42|0.4768
71099301|NCT02554474|141707382|SUPERIORITY||Adjusted difference in mean change|1.58|||||TWO_SIDED|95.0|-1.02|4.18||||||We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing the Partners In Health Scale scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking.||4.18|-1.02|
71040053|NCT00830167|141588010|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.21||0.0729|TWO_SIDED|95.0|-0.74|0.11||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.11|-0.74|0.0729
71099302|NCT02554474|141707383|SUPERIORITY||Adjusted difference in mean change|0.05|||||TWO_SIDED|95.0|-0.05|0.16||||||We performed an intent-to-treat analysis. For the main comparison, analysis of covariance (ANCOVA) was used to estimate an adjusted mean difference comparing the Sitting at Work index scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking.||0.16|-0.05|
71099303|NCT02554474|141707384|SUPERIORITY||Adjusted difference in mean change|0.0|||||TWO_SIDED|95.0|-0.37|0.37||||||We performed an intent-to-treat analysis. For the main comparison, analysis of covariance (ANCOVA) was used to estimate an adjusted mean difference comparing the Sitting at Leisure index scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking.||0.37|-0.37|
71099304|NCT02554474|141707385|SUPERIORITY||Adjusted difference in mean change|0.54|||||TWO_SIDED|95.0|0.08|0.99||||||We performed an intent-to-treat analysis. For the main comparison, analysis of covariance (ANCOVA) was used to estimate an adjusted mean difference comparing the Walking index scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking.||0.99|0.08|
71099305|NCT02770365|141707395|EQUIVALENCE|provides 85% power of success|Equivalence ratio|1.14|||||TWO_SIDED|90.0|-2.92|12.53|||Wald's method|||||12.53|-2.92|
71099306|NCT02770365|141707396|EQUIVALENCE|the proportion of subjects with treatment success based on the improvement of the Most Bothersome Symptom (MBS) of vulvo-vaginal atrophy at Day 8.|equivalence ratio|0.94||||0.05|TWO_SIDED|90.0|-12.35|4.31|||Wald's method|||||4.31|-12.35|0.05
71099307|NCT02991859|141707397|OTHER||3 parameter Emax model|13.5|||||TWO_SIDED|95.0|9.39|19.39|||||FF E0 (Response of Placebo participants)|||19.39|9.39|
71099308|NCT02991859|141707397|OTHER||3 parameter Emax model|14.44|||||TWO_SIDED|95.0|8.21|25.4|||||Emax-Maximum Dose response|||25.40|8.21|
71099309|NCT02991859|141707397|OTHER||3 parameter Emax model|48.52|||||TWO_SIDED|95.0|18.21|129.32|||||ED50-Dose at which 50% of the maximum dose response reached (mcg)|||129.32|18.21|
71099310|NCT02991859|141707397|OTHER||3 parameter Emax model|13.5|||||TWO_SIDED|95.0|9.39|19.39|||||FP E0-Response of Placebo participants|||19.39|9.39|
71099311|NCT02991859|141707397|OTHER||3 parameter Emax model|14.44|||||TWO_SIDED|95.0|8.21|25.4|||||FP Emax-Maximum Dose response|||25.40|8.21|
71099312|NCT02991859|141707397|OTHER||3 parameter Emax model|1081.27|||||TWO_SIDED|95.0|448.0|2609.66|||||FP ED50-Dose at which 50% of the maximum dose response reached (mcg)|||2609.66|448.00|
71099313|NCT02991859|141707397|OTHER||3 parameter Emax model|13.5|||||TWO_SIDED|95.0|9.39|19.39|||||BUD E0-Response of Placebo participants|||19.39|9.39|
71099314|NCT02991859|141707397|OTHER||3 parameter Emax model|14.44|||||TWO_SIDED|95.0|8.21|25.4|||||BUD Emax-Maximum Dose response|||25.40|8.21|
71099315|NCT02991859|141707397|OTHER||3 parameter Emax model|1467.36|||||TWO_SIDED|95.0|546.51|3939.84|||||BUD ED50-Dose at which 50% of the maximum dose response reached (mcg)|||3939.84|546.51|
71040054|NCT00830167|141588011|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.21||0.0238|TWO_SIDED|95.0|-0.81|0.0||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.00|-0.81|0.0238
71040055|NCT00830167|141588012|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.2||0.0075|TWO_SIDED|95.0|-0.89|-0.1||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.10|-0.89|0.0075
71099316|NCT02991859|141707398|OTHER||Exponential power-law model|176.09|||||TWO_SIDED|95.0|162.87|190.38|||||FF E0-Response of Placebo participants|||190.38|162.87|
71099317|NCT02991859|141707398|OTHER||exponential power-law model|899.99|||||TWO_SIDED|95.0|698.36|1101.62|||||FF ED50 Dose at which 50% of the maximum dose response reached|||1101.62|698.36|
71099318|NCT02991859|141707398|OTHER||exponential power-law model|176.09|||||TWO_SIDED|95.0|162.87|190.38|||||FP E0-Response of Placebo participants|||190.38|162.87|
71099319|NCT02991859|141707398|OTHER||exponential power-law model|1986.05|||||TWO_SIDED|95.0|1574.7|2397.39|||||FP ED50 - Dose at which 50% of the maximum dose response reached (mcg)|||2397.39|1574.70|
71099320|NCT02991859|141707398|OTHER||exponential power-law model|176.09|||||TWO_SIDED|95.0|162.87|190.38|||||BUD E0 - Response of Placebo participants|||190.38|162.87|
71099321|NCT02991859|141707398|OTHER||exponential power-law model|1927.42|||||TWO_SIDED|95.0|1698.47|2156.37|||||BUD ED50 - Dose at which 50% of the maximum dose response reached (mcg)|||2156.37|1698.47|
71099322|NCT02991859|141707399|OTHER||Emax Model|289.73|||||TWO_SIDED|95.0|224.82|354.64|||||ED20 Cortisol Suppression 0-24 Hours Weighted Mean|||354.64|224.82|
71099323|NCT02991859|141707399|OTHER||Emax Model|194.09|||||TWO_SIDED|95.0|72.82|517.28|||||ED80 for AMP PC20|||517.28|72.82|
71099324|NCT02991859|141707400|OTHER||Emax Model|639.36|||||TWO_SIDED|95.0|506.94|771.79|||||ED20 for Cortisol Suppression 0-24 Hours Weighted Mean|||771.79|506.94|
71099325|NCT02991859|141707400|OTHER||Emax Model|4325.07|||||TWO_SIDED|95.0|1792.02|10438.64|||||ED80 for AMP PC20|||10438.64|1792.02|
71099326|NCT02991859|141707401|OTHER||Emax Model|620.49|||||TWO_SIDED|95.0|546.79|694.2|||||ED20 for Cortisol Suppression 0-24 Hours Weighted Mean|||694.20|546.79|
71099327|NCT02991859|141707401|OTHER||Emax Model|5869.45|||||TWO_SIDED|95.0|2186.03|15759.35|||||ED80 for AMP PC20|||15759.35|2186.03|
71099328|NCT04223687|141707465|SUPERIORITY||||||<|0.01||||||a priori threshold for statistical significance, p\<0.05|Chi-squared|||||||<0.01
71099329|NCT04223687|141707466|SUPERIORITY||||||<|0.01||||||a priori threshold for statistical significance, p\<0.05|t-test, 2 sided|||||||<0.01
71099330|NCT04223687|141707467|SUPERIORITY|||||||0.03||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.03
71099331|NCT04223687|141707468|SUPERIORITY|||||||0.37||||||a priori threshold for statistical significance, p\<0.05|Chi-squared|||||||0.37
71099332|NCT04223687|141707469|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
71099333|NCT04223687|141707470|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
71099334|NCT04223687|141707471|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
71099335|NCT04223687|141707472|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance, p\<0.05|Chi-squared|||||||<0.001
70994223|NCT01021852|141497233|SUPERIORITY_OR_OTHER||Difference in LS Means|4.1|STANDARD_ERROR_OF_MEAN|1.42||0.004|TWO_SIDED|95.0|1.3|6.9|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||6.9|1.3|0.004
70994224|NCT01021852|141497233|SUPERIORITY_OR_OTHER||Difference in LS Means|9.7|STANDARD_ERROR_OF_MEAN|1.43|<|0.001|TWO_SIDED|95.0|6.9|12.5|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||12.5|6.9|<0.001
70994225|NCT01021852|141497233|SUPERIORITY_OR_OTHER||Difference in LS Means|8.7|STANDARD_ERROR_OF_MEAN|1.43|<|0.001|TWO_SIDED|95.0|5.9|11.5|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||11.5|5.9|<0.001
70994226|NCT01021852|141497234|SUPERIORITY_OR_OTHER||Difference in LS Means|-30.8|STANDARD_ERROR_OF_MEAN|6.29|<|0.001|TWO_SIDED|95.0|-43.2|-18.4|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-18.4|-43.2|<0.001
70994227|NCT01021852|141497234|SUPERIORITY_OR_OTHER||Difference in LS Means|-32.5|STANDARD_ERROR_OF_MEAN|6.31|<|0.001|TWO_SIDED|95.0|-44.9|-20.1|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-20.1|-44.9|<0.001
70994228|NCT01021852|141497234|SUPERIORITY_OR_OTHER||Difference in LS Means|-30.9|STANDARD_ERROR_OF_MEAN|6.21|<|0.001|TWO_SIDED|95.0|-43.2|-18.7|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-18.7|-43.2|<0.001
70994229|NCT01021852|141497234|SUPERIORITY_OR_OTHER||Difference in LS Means|-45.8|STANDARD_ERROR_OF_MEAN|6.22|<|0.001|TWO_SIDED|95.0|-58.0|-33.5|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-33.5|-58.0|<0.001
70994230|NCT01021852|141497234|SUPERIORITY_OR_OTHER||Difference in LS Means|-15.5|STANDARD_ERROR_OF_MEAN|5.65||0.006|TWO_SIDED|95.0|-26.7|-4.4|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-4.4|-26.7|0.006
70994231|NCT01021852|141497234|SUPERIORITY_OR_OTHER||Difference in LS Means|-13.2|STANDARD_ERROR_OF_MEAN|5.66||0.02|TWO_SIDED|95.0|-24.4|-2.1|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-2.1|-24.4|0.020
70994232|NCT01021852|141497234|SUPERIORITY_OR_OTHER||Difference in LS Means|-25.7|STANDARD_ERROR_OF_MEAN|5.67|<|0.001|TWO_SIDED|95.0|-36.8|-14.5|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-14.5|-36.8|<0.001
71099336|NCT04223687|141707473|SUPERIORITY|||||||0.06||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.06
71099337|NCT04223687|141707474|SUPERIORITY|||||||0.37||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.37
71099338|NCT04223687|141707475|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
71099339|NCT04223687|141707476|SUPERIORITY|||||||0.42||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.42
71040056|NCT00830167|141588013|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.21||0.0023|TWO_SIDED|95.0|-1.01|-0.18||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.18|-1.01|0.0023
71040057|NCT00830167|141588014|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.22||0.2568|TWO_SIDED|95.0|-0.57|0.29||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.29|-0.57|0.2568
71040058|NCT00830167|141588015|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.22||0.1011|TWO_SIDED|95.0|-0.72|0.15||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.15|-0.72|0.1011
71040059|NCT00830167|141588016|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.2||0.4165|TWO_SIDED|95.0|-0.44|0.35||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.35|-0.44|0.4165
71040060|NCT00830167|141588017|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.29|STANDARD_ERROR_OF_MEAN|1.32||0.0006|TWO_SIDED|95.0|1.7|6.88||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||6.88|1.70|0.0006
71040061|NCT00830167|141588018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.68|STANDARD_ERROR_OF_MEAN|1.84||0.1805|TWO_SIDED|95.0|-1.93|5.29||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||5.29|-1.93|0.1805
71040062|NCT00830167|141588019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|1.5||0.077|TWO_SIDED|95.0|-0.81|5.1||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||5.10|-0.81|0.0770
71040063|NCT00830167|141588020|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.83|STANDARD_ERROR_OF_MEAN|1.2||0.0648|TWO_SIDED|95.0|-0.54|4.19||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||4.19|-0.54|0.0648
71040064|NCT00830167|141588021|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.59|STANDARD_ERROR_OF_MEAN|1.94||0.2068|TWO_SIDED|95.0|-2.23|5.41||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||5.41|-2.23|0.2068
71040065|NCT00830167|141588022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|1.92||0.548|TWO_SIDED|95.0|-4.0|3.54||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||3.54|-4.00|0.5480
71040066|NCT00830167|141588023|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.42|STANDARD_ERROR_OF_MEAN|1.72||0.0052|TWO_SIDED|95.0|1.04|7.8||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||7.80|1.04|0.0052
71040067|NCT00830167|141588024|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.64|STANDARD_ERROR_OF_MEAN|1.39||0.0287|TWO_SIDED|95.0|-0.08|5.37||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||5.37|-0.08|0.0287
71040068|NCT00830167|141588025|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.25||0.0262|TWO_SIDED|95.0|-0.97|0.01||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.01|-0.97|0.0262
71040069|NCT00830167|141588026|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.28||0.1561|TWO_SIDED|95.0|-0.83|0.27||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.27|-0.83|0.1561
71040070|NCT00830167|141588027|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.19|STANDARD_ERROR_OF_MEAN|2.04||0.0013|TWO_SIDED|95.0|-10.2|-2.18||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-2.18|-10.20|0.0013
71040071|NCT02224053|141588028|NON_INFERIORITY_OR_EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%|Geometric mean ratio|106.66|||||TWO_SIDED|90.0|100.26|113.46|||||AZD9291+omeprazole / AZD9291 alone|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being within 80% to 125% was 90% (95% for each parameter). Within subject CV assumed to be 23%. 5% change in exposure also assumed.||113.46|100.26|
71099340|NCT04223687|141707477|SUPERIORITY|||||||0.13||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.13
71040072|NCT02224053|141588029|NON_INFERIORITY_OR_EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%|Geometric mean ratio|101.65|||||TWO_SIDED|90.0|94.65|109.16|||||AZD9291+omeprazole / AZD9291 alone|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being within 80% to 125% was 90% (95% for each parameter). Within subject CV assumed to be 23%. 5% change in exposure also assumed.||109.16|94.65|
71040073|NCT02224053|141588038|NON_INFERIORITY_OR_EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%|Geometric mean ratio|94.79|||||TWO_SIDED|90.0|88.77|101.21||||||AZ5104||101.21|88.77|
71040074|NCT02224053|141588038|NON_INFERIORITY_OR_EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%|Geomteric mean ratio|89.7|||||TWO_SIDED|90.0|83.89|95.91||||||AZ7550||95.91|83.89|
71040075|NCT02224053|141588039|NON_INFERIORITY_OR_EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%|Geometric mean ratio|102.32|||||TWO_SIDED|90.0|96.87|108.07|||||AZD9291+omeprazole / AZD9291 alone|AZ5104||108.07|96.87|
71040076|NCT02224053|141588039|NON_INFERIORITY_OR_EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%|Geometric mean ratio|94.03|||||TWO_SIDED|90.0|89.92|98.33||||||AZ7550||98.33|89.92|
71040077|NCT00860262|141588053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.6|STANDARD_ERROR_OF_MEAN|1.18|<|0.0001|TWO_SIDED|95.0|-12.9|-8.3|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus Telmisartan 80 mg|||-8.3|-12.9|<0.0001
71040078|NCT00860262|141588053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4|STANDARD_ERROR_OF_MEAN|1.18||0.0002|TWO_SIDED|95.0|-6.7|-2.1|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus amlodipine 10 mg|||-2.1|-6.7|0.0002
71040079|NCT00860262|141588054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.6|STANDARD_ERROR_OF_MEAN|1.25|<|0.0001|TWO_SIDED|95.0|-13.1|-8.2|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus telmisartan 80 mg|||-8.2|-13.1|<0.0001
71040080|NCT00860262|141588054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|1.24||0.0001|TWO_SIDED|95.0|-7.3|-2.4|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus amlodipine 10 mg|||-2.4|-7.3|0.0001
71040081|NCT00860262|141588055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.2|STANDARD_ERROR_OF_MEAN|1.24|<|0.0001|TWO_SIDED|95.0|-12.6|-7.7|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus telmisartan 80 mg|||-7.7|-12.6|<0.0001
71099341|NCT04223687|141707478|SUPERIORITY||||||<|0.01||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.01
71040082|NCT00860262|141588055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|1.24||0.0001|TWO_SIDED|95.0|-7.2|-2.4|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus amlodipine 10 mg|||-2.4|-7.2|0.0001
71040083|NCT00860262|141588056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.8|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|-10.2|-5.4|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus telmisartan 80 mg|||-5.4|-10.2|<0.0001
71040084|NCT00860262|141588056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.21||0.0001|TWO_SIDED|95.0|-7.0|-2.3|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus amlodipine 10 mg|||-2.3|-7.0|0.0001
71040085|NCT00860262|141588057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.4|STANDARD_ERROR_OF_MEAN|1.23|<|0.0001|TWO_SIDED|95.0|-8.8|-4.0|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus telmisartan 80 mg|||-4.0|-8.8|<0.0001
71040086|NCT00860262|141588057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|1.23||0.0077|TWO_SIDED|95.0|-5.7|-0.9|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus amlodipine 10 mg|||-0.9|-5.7|0.0077
71040087|NCT00593827|141588092|SUPERIORITY_OR_OTHER|||||||0.03|||||||Log Rank|||||||0.03
71040088|NCT00593827|141588093|SUPERIORITY_OR_OTHER|||||||0.05|||||||Log Rank|||||||0.05
71040089|NCT00593827|141588096|SUPERIORITY_OR_OTHER|||||||0.11|||||||Log Rank|||||||0.11
71099342|NCT00425854|141707482|SUPERIORITY_OR_OTHER||Maximum Likelihood|0.048|||||TWO_SIDED|95.0|0.001|0.238|||||Maximum Likelihood estimates. The clinical benefit rate for Cohort A was calculated by relating the number of patients with CB to all treated patients in Cohort B. The CI is an exact Clopper Pearson CI.|||0.238|0.001|
71040090|NCT00274625|141588116|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Fisher Exact|||||||0.60
71040091|NCT00880334|141588133|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.939|TWO_SIDED|95.0|0.69|1.49|||Log Rank|||The study was designed with 80% power to detect 60% improvement in median PFS from 18 to 28.8 weeks (Vandetanib+docetaxel/Placebo+docetaxel hazard ratio of 0.625) with the addition of Vandetanib while maintaining an overall significance level of 5% in a one-sided test. This assumed exponential distribution of events, accrual of 1.75 patients per week (7-8 patients per month) for 78 weeks with 34 weeks of additional follow-up (112 weeks total). Full information was 118 PFS events.||1.49|0.69|0.939
71040092|NCT00880334|141588135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||0.873|TWO_SIDED|95.0|0.81|1.79|||Log Rank|||||1.79|0.81|.873
71040093|NCT00880334|141588136|SUPERIORITY_OR_OTHER|||||||0.56|||||||Fisher Exact|||||||0.56
71040094|NCT00880334|141588137|SUPERIORITY_OR_OTHER|||||||0.31|||||||Fisher Exact|||||||0.31
71040095|NCT01993940|141588191|SUPERIORITY_OR_OTHER||Difference|18.9|STANDARD_ERROR_OF_MEAN|4.12|<|0.0001|TWO_SIDED|95.0|10.8|27.0||To control the overall type I error rate to be ≤ 0.05 for the primary and secondary efficacy endpoints, a fixed-sequence (hierarchical) testing approach was applied.|Cochran-Mantel-Haenszel|P-value was calculated by Cochran-Mantel-Haenszel test adjusted by the opioid dose strata.||||27.0|10.8|<0.0001
71040096|NCT01993940|141588192|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.243|<|0.0001|TWO_SIDED|95.0|0.92|1.88|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||1.88|0.92|<0.0001
71040097|NCT01993940|141588193|SUPERIORITY_OR_OTHER||LS Mean Difference|2.17|STANDARD_ERROR_OF_MEAN|0.277|<|0.0001|TWO_SIDED|95.0|1.63|2.71|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||2.71|1.63|<0.0001
71040098|NCT01993940|141588194|SUPERIORITY_OR_OTHER||LS Mean Difference|1.15|STANDARD_ERROR_OF_MEAN|0.232|<|0.0001|TWO_SIDED|95.0|0.7|1.61|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||1.61|0.70|<0.0001
71099343|NCT00425854|141707487|SUPERIORITY_OR_OTHER||Clinical benefit rate|0.1|||||TWO_SIDED|95.0|0.02|0.27|||Maxium Likelihood||Maximum Likelihood estimates. The clinical benefit rate for Cohort A was calculated by relating the number of patients with CB to all treated patients in Cohort A. The confidence interval (CI) is an exact Clopper Pearson CI.|||0.27|0.02|
71099344|NCT02057666|141707517|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.406||||0.027|TWO_SIDED|95.0|0.182|0.903|||Log Rank|Stratified as per randomisation.|Stratified as per randomisation.|||0.903|0.182|0.027
70994233|NCT01021852|141497234|SUPERIORITY_OR_OTHER||Difference in LS Means|-30.0|STANDARD_ERROR_OF_MEAN|5.69|<|0.001|TWO_SIDED|95.0|-41.2|-18.8|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-18.8|-41.2|<0.001
70994234|NCT01021852|141497235|SUPERIORITY_OR_OTHER||Difference in LS Means|-10.2|STANDARD_ERROR_OF_MEAN|4.43||0.022|TWO_SIDED|95.0|-18.9|-1.5|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-1.5|-18.9|0.022
70994235|NCT01021852|141497235|SUPERIORITY_OR_OTHER||Difference in LS Means|-15.7|STANDARD_ERROR_OF_MEAN|4.44|<|0.001|TWO_SIDED|95.0|-24.5|-7.0|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-7.0|-24.5|<0.001
70994236|NCT01021852|141497235|SUPERIORITY_OR_OTHER||Difference in LS Means|-23.5|STANDARD_ERROR_OF_MEAN|4.38|<|0.001|TWO_SIDED|95.0|-32.1|-14.9|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-14.9|-32.1|<0.001
70994237|NCT01021852|141497235|SUPERIORITY_OR_OTHER||Difference in LS Means|-20.3|STANDARD_ERROR_OF_MEAN|4.38|<|0.001|TWO_SIDED|95.0|-29.0|-11.7|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-11.7|-29.0|<0.001
70994238|NCT01021852|141497235|SUPERIORITY_OR_OTHER||Difference in LS Means|-8.9|STANDARD_ERROR_OF_MEAN|4.61||0.055|TWO_SIDED|95.0|-18.0|0.2|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||0.2|-18.0|0.055
70994239|NCT01021852|141497235|SUPERIORITY_OR_OTHER||Difference in LS Means|-8.7|STANDARD_ERROR_OF_MEAN|4.61||0.06|TWO_SIDED|95.0|-17.8|0.4|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||0.4|-17.8|0.060
70994240|NCT01021852|141497235|SUPERIORITY_OR_OTHER||Difference in LS Means|-19.5|STANDARD_ERROR_OF_MEAN|4.62|<|0.001|TWO_SIDED|95.0|-28.6|-10.4|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-10.4|-28.6|<0.001
70994241|NCT01021852|141497235|SUPERIORITY_OR_OTHER||Difference in LS Means|-11.3|STANDARD_ERROR_OF_MEAN|4.63||0.015|TWO_SIDED|95.0|-20.5|-2.2|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-2.2|-20.5|0.015
70994242|NCT01021852|141497236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-9.5|12.2||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||12.2|-9.5|
70994243|NCT01021852|141497236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-10.3|11.2||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||11.2|-10.3|
70994244|NCT01021852|141497236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.5|||||TWO_SIDED|95.0|-4.2|18.3||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||18.3|-4.2|
71099345|NCT02057666|141707518|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.465||||0.448|TWO_SIDED|95.0|0.065|3.355|||Log Rank|||||3.355|0.065|0.448
71099346|NCT00498485|141707532|SUPERIORITY_OR_OTHER||||||<|0.04|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis = drug-treated would have a higher global impression of change than placebo treated.||||<0.04
70994245|NCT01021852|141497236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.5|||||TWO_SIDED|95.0|-2.3|20.4||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||20.4|-2.3|
70994246|NCT01021852|141497237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|||||TWO_SIDED|95.0|-1.0|10.2||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||10.2|-1.0|
71099347|NCT01539525|141707534|SUPERIORITY_OR_OTHER||Slope|-0.078|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|95.0|-0.118|-0.038|||Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Parameter estimated is the linear effect of time (in months)|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.||-0.038|-0.118|<0.001
70994247|NCT01021852|141497237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-3.6|4.8||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||4.8|-3.6|
70994248|NCT01021852|141497237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-2.7|6.6||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||6.6|-2.7|
70994249|NCT01021852|141497237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|||||TWO_SIDED|95.0|-4.5|2.3||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||2.3|-4.5|
70994250|NCT02802878|141497253|SUPERIORITY|||||||0.67||||||Adjusted for two observations per subject.|Regression, Linear|Side treated as a repeated factor||||||.67
70994251|NCT00230100|141497376|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Mixed Models Analysis|||"Implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. The MMANOVA approach estimates a separate mean for each phase of treatment per group. The MMANOVA is called a mixed model because it includes both fixed (e.g., treatment, gender) and random (subject-specific) terms. MMANOVA allows for randomly missing observations (not included in analysis)."||||<0.05
70994252|NCT00230100|141497377|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Mixed Models Analysis|||"Implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. The MMANOVA approach estimates a separate mean for each phase of treatment per group. The MMANOVA is called a mixed model because it includes both fixed (e.g., treatment, gender) and random (subject-specific) terms. MMANOVA allows for randomly missing observations (not included in analysis)."||||<0.05
70994253|NCT00230100|141497378|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Mixed Models Analysis|||"Implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. The MMANOVA approach estimates a separate mean for each phase of treatment per group. The MMANOVA is called a mixed model because it includes both fixed (e.g., treatment, gender) and random (subject-specific) terms. MMANOVA allows for randomly missing observations (not included in analysis)."||||<0.05
70994254|NCT00230100|141497379|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Mixed Models Analysis|||It was hypothesized that the single-gender group composition and women-focused group content (WRG) would result in better substance abuse treatment outcomes (lower ASI alcohol composite scores) than standard mixed-gender group treatment (GDC).||||<0.05
70994255|NCT00230100|141497380|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.009|||||||Mixed Models Analysis|||||||<0.009
70994256|NCT01906866|141497392|SUPERIORITY||Mean Difference (Final Values)|32.32|STANDARD_ERROR_OF_MEAN|15.1|=|0.035|TWO_SIDED|95.0|2.38|62.26|||Mixed Models Analysis|||||62.26|2.38|=0.035
71040099|NCT01993940|141588195|SUPERIORITY_OR_OTHER||LS Mean Difference|0.75|STANDARD_ERROR_OF_MEAN|0.227||0.0011|TWO_SIDED|95.0|0.3|1.19|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||1.19|0.30|0.0011
71040100|NCT04404907|141588204|OTHER|ANOVA||||||0.02|||||||ANOVA|||feel more attractive||||0.02
70994257|NCT01906866|141497393|SUPERIORITY||Mean Difference (Final Values)|-25.2|STANDARD_ERROR_OF_MEAN|9.787|=|0.011|TWO_SIDED|95.0|-44.61|-5.8|||Mixed Models Analysis|||||-5.8|-44.61|=0.011
70994258|NCT01906866|141497396|SUPERIORITY|||||||0.053|||||||MMRM|||Mixed Models for Repeated Measures (MMRM) analysis||||0.053
70994259|NCT01906866|141497396|SUPERIORITY|||||||0.039|||||||MI analysis|||||||0.039
70994260|NCT01906866|141497398|SUPERIORITY|||||||0.077|||||||MMRM|||||||0.077
70994261|NCT01906866|141497399|SUPERIORITY|||||||0.04|||||||Chi-squared|||||||0.04
70994262|NCT00438399|141497406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0|||||Wilcoxon (Mann-Whitney)|||The purpose of the study was to demonstrate the superiority of Clobetasol propionate shampoo over one of three other comparators, in terms of Subject's overall preference. It was to be analyzed using a non parametric two-sided Wilcoxon rank Signed test on ITT population.||||0.0003
71040101|NCT04404907|141588204|OTHER|ANOVA||||||0.001|||||||ANOVA|||tanning helps relax||||0.001
71040102|NCT04404907|141588204|OTHER|||||||0.34|||||||ANOVA|||confident with a tan||||0.34
71040103|NCT04404907|141588204|OTHER|||||||0.0004|||||||ANOVA|||Social activity||||0.0004
71040104|NCT04404907|141588204|OTHER|||||||0.66|||||||ANOVA|||Important to protect skin from the sun||||0.66
71040105|NCT04404907|141588204|OTHER|||||||0.16|||||||ANOVA|||Concern about develop skin cancer||||0.16
71099348|NCT01539525|141707534|SUPERIORITY_OR_OTHER||Slope|0.005|STANDARD_ERROR_OF_MEAN|0.003||0.066|TWO_SIDED|95.0|-0.0004|0.011|||Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Parameter estimated is the quadratic effect of time (in months)|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.||0.011|-0.0004|0.066
71099349|NCT01539525|141707534|SUPERIORITY_OR_OTHER||Slope|-0.078|STANDARD_ERROR_OF_MEAN|0.034||0.038|TWO_SIDED|95.0|-0.151|-0.004||P-value adjusted for multiple comparisons using Holm's step-down multiple testing procedure. The a priori threshold for statistical significance was p \< 0.05.|Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Estimated parameter is treatment x linear time interaction term coefficient- Motivational Interview- Nurse vs. Treatment as Usual|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.||-0.004|-0.151|0.038
71099350|NCT01539525|141707534|SUPERIORITY_OR_OTHER||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.034||0.008|TWO_SIDED|95.0|-0.157|-0.023||P-value adjusted for multiple comparisons using Holm's step-down multiple testing procedure. The a priori threshold for statistical significance was p \< 0.025|Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Estimated parameter is treatment x linear time interaction term coefficient- Motivational Interview- Computer vs. Treatment as Usual|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.||-0.023|-0.157|0.008
71099351|NCT01539525|141707534|SUPERIORITY_OR_OTHER||Slope|0.011|STANDARD_ERROR_OF_MEAN|0.005||0.031|TWO_SIDED|95.0|0.001|0.022||P-value adjusted for multiple comparisons using Holm's step-down multiple testing procedure. The a priori threshold for statistical significance was p \< 0.05.|Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Estimated parameter is treatment x quadratic time interaction term coefficient- Motivational Interview- Nurse vs. Treatment as Usual|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.||0.022|0.001|0.031
71099352|NCT01539525|141707534|SUPERIORITY_OR_OTHER||Slope|0.012|STANDARD_ERROR_OF_MEAN|0.0005||0.01|TWO_SIDED|95.0|0.002|0.021||P-value adjusted for multiple comparisons using Holm's step-down multiple testing procedure. The a priori threshold for statistical significance was p \< 0.025.|Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Estimated parameter is treatment x quadratic time interaction term coefficient- Motivational Interview- Computer vs. Treatment as Usual|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.||0.021|0.002|0.010
71099353|NCT01539525|141707535|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.931||||0.81|TWO_SIDED|95.0|0.559|1.551|||Regression, Logistic|adjusted for stratifying variables- primary substance and pregnancy status|Estimated odds ratio is for Motivational Interview- Nurse vs. Treatment as Usual|||1.551|0.559|0.810
71099354|NCT01539525|141707535|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.968||||0.99|TWO_SIDED|95.0|0.579|1.617|||Regression, Logistic|adjusted for stratifying variables- primary substance and pregnancy status|Estimated odds ratio is for Motivational Interview- Computer vs. Treatment as Usual|||1.617|0.579|0.990
71040106|NCT04404907|141588204|OTHER|||||||0.29|||||||ANOVA|||Chances of getting skin cancer are high||||0.29
71040107|NCT00702507|141588260|SUPERIORITY_OR_OTHER||Percentage of participants|29.2|||||TWO_SIDED|95.0|22.4|36.7|||||Percentage of participants with overall cure at the test-of-cure visit (Day 14) of the initial episode for participants in the MITT Population|||36.7|22.4|
71040108|NCT01277510|141588268|SUPERIORITY_OR_OTHER_LEGACY||Difference (Cinacalcet - Placebo)|35.5||||0.017|TWO_SIDED|95.0|8.76|62.24|||Cochran-Mantel-Haenszel|Cochran- Mantel-Haenszel (CMH) test stratified by baseline age group (6 -\<12 years old or 12 - \<18 years old).||A hierarchical testing procedure was used to test the primary and biochemical secondary endpoints (Outcome Measures 1-5). The primary endpoint was tested at a significance level of 0.05. The four biochemical secondary endpoints were to be tested using Holm's method at 0.05 should the primary endpoint achieve a significant result.||62.24|8.76|0.017
71040109|NCT01277510|141588269|SUPERIORITY_OR_OTHER_LEGACY||Difference (Cinacalcet - Placebo)|3.46||||0.826|TWO_SIDED|95.0|-22.58|29.51|||Cochran-Mantel-Haenszel|Cochran- Mantel-Haenszel (CMH) test stratified by baseline age group (6 -\<12 years old or 12 - \<18 years old).||The secondary endpoint with the smallest p-value was first compared at a significance level of 0.0125. If the p-value was \> 0.0125, all 4 secondary endpoints were non-significant; if ≤ 0.0125, the null hypothesis for that endpoint was rejected. Next, the 2nd smallest p-value was compared at a level of 0.0167; if \> 0.0167, the remaining 3 endpoints were not significant, or, the null hypothesis of that endpoint was rejected. The other 2 endpoints were analyzed similarly, at 0.025 and 0.05.||29.51|-22.58|0.826
71040110|NCT01277510|141588270|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.7||||0.147|TWO_SIDED|95.0|-8.6|1.3|||ANCOVA|Baseline age group was used as covariate.|Cinacalcet-Placebo|The secondary endpoint with the smallest p-value was first compared at a significance level of 0.0125. If the p-value was \> 0.0125, all 4 secondary endpoints were non-significant; if ≤ 0.0125, the null hypothesis for that endpoint was rejected. Next, the 2nd smallest p-value was compared at a level of 0.0167; if \> 0.0167, the remaining 3 endpoints were not significant, or, the null hypothesis of that endpoint was rejected. The other 2 endpoints were analyzed similarly, at 0.025 and 0.05.||1.3|-8.6|0.147
71040111|NCT01277510|141588271|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.3||||0.454|TWO_SIDED|95.0|-19.4|8.9|||ANCOVA|Baseline age group was used as covariate|Cinacalcet-Placebo|The secondary endpoint with the smallest p-value was first compared at a significance level of 0.0125. If the p-value was \> 0.0125, all 4 secondary endpoints were non-significant; if ≤ 0.0125, the null hypothesis for that endpoint was rejected. Next, the 2nd smallest p-value was compared at a level of 0.0167; if \> 0.0167, the remaining 3 endpoints were not significant, or, the null hypothesis of that endpoint was rejected. The other 2 endpoints were analyzed similarly, at 0.025 and 0.05.||8.9|-19.4|0.454
71040112|NCT01277510|141588272|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-10.0||||0.117|TWO_SIDED|95.0|-22.5|2.6|||ANCOVA|Baseline age group was used as covariate.|Cinacalcet-Placebo|The secondary endpoint with the smallest p-value was first compared at a significance level of 0.0125. If the p-value was \> 0.0125, all 4 secondary endpoints were non-significant; if ≤ 0.0125, the null hypothesis for that endpoint was rejected. Next, the 2nd smallest p-value was compared at a level of 0.0167; if \> 0.0167, the remaining 3 endpoints were not significant, or, the null hypothesis of that endpoint was rejected. The other 2 endpoints were analyzed similarly, at 0.025 and 0.05.||2.6|-22.5|0.117
71040113|NCT01277510|141588273|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.896|TWO_SIDED|95.0|-3.1|3.6||No adjustments for multiplicity were made.|ANCOVA|Baseline age group was used as covariate.|Cinacalcet-Placebo|||3.6|-3.1|0.896
71040114|NCT01277510|141588275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8||||0.854|TWO_SIDED|95.0|-9.4|7.9|||ANCOVA|Baseline age group was used as covariate.|Cinacalcet-Placebo|||7.9|-9.4|0.854
71040115|NCT00784095|141588312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9||||0.047|TWO_SIDED|95.0|0.04|5.7|||Mixed Models Analysis|||Intervention (Preparation and Completion) versus True Control at 8 weeks||5.7|.04|.047
71040116|NCT00784095|141588312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8|||||TWO_SIDED|95.0|-1.1|4.7||||||Intervention (Preparation and Completion) versus Attention Control at 8 weeks||4.7|-1.1|
71040117|NCT00784095|141588313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|-3.2|5.6||||||Intervention (Preparation and Completion) versus True Control at 8 weeks||5.6|-3.2|
71040118|NCT00784095|141588313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-5.6|3.3||||||Intervention (Preparation and Completion) versus Attention Control at 8 weeks||3.3|-5.6|
71040119|NCT00784095|141588314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|||||TWO_SIDED|95.0|-6.2|2.9||||||Intervention (Preparation and Completion) versus True Control at 8 weeks||2.9|-6.2|
71040120|NCT00784095|141588314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6|||||TWO_SIDED|95.0|-8.2|1.0||||||Intervention (Preparation and Completion) versus Attention Control at 8 weeks||1.0|-8.2|
71040121|NCT00784095|141588315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-4.5|3.4||||||Intervention (Preparation and Completion) versus True Control at 8 weeks||3.4|-4.5|
71040122|NCT00784095|141588315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-5.1|3.0||||||Intervention versus Attention Control at 8 weeks.||3.0|-5.1|
71040123|NCT00784095|141588316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-4.8|3.7||||||Intervention (Preparation and Completion) versus True Control at 8 weeks||3.7|-4.8|
71040124|NCT00784095|141588316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|||||TWO_SIDED|95.0|-1.9|6.7||||||Intervention (Preparation and Completion) versus Attention Control at 8 weeks.||6.7|-1.9|
71040125|NCT01540045|141588318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.||||0.013
71040126|NCT01540045|141588319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.671|TWO_SIDED||||||t-test, 2 sided|||we evaluated body fat before and after 2 cycles of cisplatin/paclitaxel based chemotheprapy||||0.671
71040127|NCT01540045|141588319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.694|TWO_SIDED||||||t-test, 2 sided|||we evaluated lean body mass before and after 2 cycles of cisplatin/paclitaxel based chemotheprapy||||0.694
71040128|NCT01540045|141588320|SUPERIORITY_OR_OTHER_LEGACY|||||||0.118|TWO_SIDED||||||t-test, 2 sided|||||||0.118
71040129|NCT01540045|141588321|SUPERIORITY_OR_OTHER_LEGACY|||||||0.607|TWO_SIDED||||||McNemar|||Subjective global assessment (PG-SGA) was used to assess and classify patients as having severe or moderate malnourishment (B or C) or as being well nourished (A).||||0.607
71040130|NCT01540045|141588322|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015|TWO_SIDED||||||t-test, 2 sided|||protein consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds compared to \< Sweet perception thresholds after chemotherapy||||0.015
71040131|NCT01540045|141588322|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||animal protein consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs \< Sweet perception thresholds after chemotherapy||||0.010
71040132|NCT01540045|141588322|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||FAT consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs \< Sweet perception thresholds after chemotherapy||||0.004
70994263|NCT00438399|141497406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0|||||Wilcoxon (Mann-Whitney)|||The purpose of the study was to demonstrate the superiority of Clobetasol propionate shampoo over one of three other comparators, in terms of Subject's overall preference. It was to be analyzed using a non parametric two-sided Wilcoxon rank Signed test on ITT population.||||0.007
70994264|NCT00438399|141497406|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||The purpose of the study was to demonstrate the superiority of Clobetasol propionate shampoo over one of three other comparators, in terms of Subject's overall preference. It was to be analyzed using a non parametric two-sided Wilcoxon rank Signed test on ITT population.||||<0.0001
70994265|NCT00723073|141497407|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99|STANDARD_DEVIATION|1.0||0.96|TWO_SIDED|95.0|0.89|1.1|||Fisher Exact|||||1.10|0.89|0.96
70994266|NCT00723073|141497408|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|STANDARD_DEVIATION|1.0|>|0.99|TWO_SIDED|95.0|0.38|2.7|||Fisher Exact|||||2.70|0.38|>0.99
70994267|NCT00723073|141497409|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.93|STANDARD_DEVIATION|1.0|>|0.99|TWO_SIDED|95.0|0.44|1.97|||Fisher Exact|||||1.97|0.44|>0.99
70994268|NCT00723073|141497410|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.12|STANDARD_DEVIATION|1.0||0.48|TWO_SIDED|95.0|0.61|2.07|||Fisher Exact|||||2.07|0.61|0.48
70994269|NCT00723073|141497411|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.57|STANDARD_DEVIATION|1.0||0.57|TWO_SIDED|95.0|0.1|3.37|||Fisher Exact|||||3.37|0.10|0.57
70994270|NCT00723073|141497412|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||Chi-squared|||||||0.66
70994271|NCT00723073|141497415|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Fisher Exact|||||||0.22
70994272|NCT00723073|141497416|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Fisher Exact|||||||0.11
70994273|NCT03334396|141497417|SUPERIORITY||Odds Ratio (OR)|2.61||||0.02|TWO_SIDED|95.0|1.17|5.84|||Regression, Logistic|||||5.84|1.17|0.020
70994274|NCT03334396|141497417|SUPERIORITY||Odds Ratio (OR)|4.1|||<|0.001|TWO_SIDED|95.0|1.93|8.7|||Regression, Logistic|||||8.70|1.93|<0.001
70994275|NCT03334396|141497418|SUPERIORITY||Odds Ratio (OR)|2.72||||0.014|TWO_SIDED|95.0|1.23|6.01|||Regression, Logistic|||||6.01|1.23|0.014
71040133|NCT01540045|141588324|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.||||0.28
70994276|NCT03334396|141497419|SUPERIORITY||Odds Ratio (OR)|2.03||||0.032|TWO_SIDED|95.0|1.06|3.88|||Regression, Logistic|||||3.88|1.06|0.032
70994277|NCT03334396|141497419|SUPERIORITY||Odds Ratio (OR)|2.46||||0.006|TWO_SIDED|95.0|1.29|4.67|||Regression, Logistic|||||4.67|1.29|0.006
70994278|NCT03334396|141497419|SUPERIORITY||Odds Ratio (OR)|3.72|||<|0.001|TWO_SIDED|95.0|2.01|6.89|||Regression, Logistic|||||6.89|2.01|<0.001
70994279|NCT03334396|141497420|SUPERIORITY||Odds Ratio (OR)|1.73||||0.21|TWO_SIDED|95.0|0.74|4.05|||Regression, Logistic|||||4.05|0.74|0.210
70994280|NCT03334396|141497420|SUPERIORITY||Odds Ratio (OR)|2.5||||0.029|TWO_SIDED|95.0|1.1|5.7|||Regression, Logistic|||||5.70|1.10|0.029
70994281|NCT03334396|141497420|SUPERIORITY||Odds Ratio (OR)|4.13|||<|0.001|TWO_SIDED|95.0|1.91|8.91|||Regression, Logistic|||||8.91|1.91|<0.001
70994282|NCT03334396|141497421|SUPERIORITY||Mean Difference (Final Values)|-13.4|STANDARD_ERROR_OF_MEAN|5.78||0.021|TWO_SIDED|95.0|-24.77|-2.03|||Mixed Models Analysis|||||-2.03|-24.77|0.021
70994283|NCT03334396|141497421|SUPERIORITY||Mean Difference (Final Values)|-17.07|STANDARD_ERROR_OF_MEAN|5.57||0.002|TWO_SIDED|95.0|-28.05|-6.1|||Mixed Models Analysis|||||-6.10|-28.05|0.002
70994284|NCT03334396|141497421|SUPERIORITY||Mean Difference (Final Values)|-24.54|STANDARD_ERROR_OF_MEAN|5.23|<|0.001|TWO_SIDED|95.0|-34.84|-14.24|||Mixed Models Analysis|||||-14.24|-34.84|<0.001
70994285|NCT03334396|141497422|SUPERIORITY||Odds Ratio (OR)|4.28||||0.025|TWO_SIDED|95.0|1.2|15.24|||Regression, Logistic|||||15.24|1.20|0.025
70994286|NCT03334396|141497422|SUPERIORITY||Odds Ratio (OR)|6.14||||0.004|TWO_SIDED|95.0|1.79|20.99|||Regression, Logistic|||||20.99|1.79|0.004
70994287|NCT03334396|141497422|SUPERIORITY||Odds Ratio (OR)|8.76|||<|0.001|TWO_SIDED|95.0|2.68|28.58|||Regression, Logistic|||||28.58|2.68|<0.001
70994288|NCT03334396|141497423|SUPERIORITY||Odds Ratio (OR)|1.6||||0.246|TWO_SIDED|95.0|0.72|3.56|||Regression, Logistic|||||3.56|0.72|0.246
70994289|NCT03334396|141497423|SUPERIORITY||Odds Ratio (OR)|1.73||||0.169|TWO_SIDED|95.0|0.79|3.77|||Regression, Logistic|||||3.77|0.79|0.169
70994290|NCT03334396|141497423|SUPERIORITY||Odds Ratio (OR)|3.62|||<|0.001|TWO_SIDED|95.0|1.82|7.18|||Regression, Logistic|||||7.18|1.82|<0.001
70994291|NCT03334396|141497424|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.103|TWO_SIDED|95.0|-0.82|0.08|||Mixed Models Analysis|||||0.08|-0.82|0.103
70994292|NCT03334396|141497424|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.352|TWO_SIDED|95.0|-0.65|0.23|||Mixed Models Analysis|||||0.23|-0.65|0.352
70994293|NCT03334396|141497424|SUPERIORITY||Mean Difference (Final Values)|-0.58||||0.006|TWO_SIDED|95.0|-1.0|-0.17|||Mixed Models Analysis|||||-0.17|-1.00|0.006
70994294|NCT03334396|141497425|SUPERIORITY||Mean Difference (Final Values)|-1.08||||0.005|TWO_SIDED|95.0|-1.84|-0.32|||Mixed Models Analysis|||||-0.32|-1.84|0.005
70994295|NCT03334396|141497425|SUPERIORITY||Mean Difference (Final Values)|-0.74||||0.051|TWO_SIDED|95.0|-1.48|0.0|||Mixed Models Analysis|||||0.00|-1.48|0.051
70994296|NCT03334396|141497425|SUPERIORITY||Mean Difference (Final Values)|-1.09||||0.002|TWO_SIDED|95.0|-1.79|-0.39|||Mixed Models Analysis|||||-0.39|-1.79|0.002
70994297|NCT03334396|141497426|SUPERIORITY||Odds Ratio (OR)|1.9||||0.019|TWO_SIDED|95.0|1.11|3.25|||Regression, Logistic|||||3.25|1.11|0.019
70994298|NCT03334396|141497426|SUPERIORITY||Mean Difference (Final Values)|2.44|||<|0.001|TWO_SIDED|95.0|1.44|4.14|||Regression, Logistic|||||4.14|1.44|<0.001
70994299|NCT03334396|141497426|SUPERIORITY||Mean Difference (Final Values)|4.18|||<|0.001|TWO_SIDED|95.0|2.51|6.96|||Regression, Logistic|||||6.96|2.51|<0.001
70994300|NCT03334396|141497427|SUPERIORITY||Odds Ratio (OR)|1.98||||0.424|TWO_SIDED|95.0|0.37|10.63|||Regression, Logistic|||||10.63|0.37|0.424
70994301|NCT03334396|141497427|SUPERIORITY||Odds Ratio (OR)|2.89||||0.182|TWO_SIDED|95.0|0.61|13.75|||Regression, Logistic|||||13.75|0.61|0.182
70994302|NCT03334396|141497427|SUPERIORITY||Odds Ratio (OR)|1.94||||0.441|TWO_SIDED|95.0|0.36|10.41|||Regression, Logistic|||||10.41|0.36|0.441
71040134|NCT01540045|141588325|SUPERIORITY_OR_OTHER_LEGACY|||||||0.889|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change in status global of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire||||0.889
71040135|NCT01540045|141588325|SUPERIORITY_OR_OTHER_LEGACY|||||||0.293|TWO_SIDED|||||clinically significant|Wilcoxon (Mann-Whitney)|||change in functional role of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire||||0.293
71040136|NCT01540045|141588325|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change in emotional functioning of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire||||0.009
71099355|NCT01539525|141707536|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.258||||0.465|TWO_SIDED|95.0|0.409|3.871|||Regression, Logistic|adjusted for stratifying variables- primary drug and pregnancy status|odds ratio estimate is for Motivational Interview- Nurse vs. Treatment as Usual|||3.871|0.409|0.465
70994303|NCT03334396|141497428|SUPERIORITY||Mean Difference (Final Values)|-5.34|STANDARD_ERROR_OF_MEAN|3.17||0.093|TWO_SIDED|95.0|-11.57|0.9|||Mixed Models Analysis|||||0.90|-11.57|0.093
70994304|NCT03334396|141497428|SUPERIORITY||Mean Difference (Final Values)|-7.97|STANDARD_ERROR_OF_MEAN|3.07||0.01|TWO_SIDED|95.0|-14.01|-1.92|||Mixed Models Analysis|||||-1.92|-14.01|0.010
70994305|NCT03334396|141497428|SUPERIORITY||Mean Difference (Final Values)|-14.79|STANDARD_ERROR_OF_MEAN|2.88|<|0.001|TWO_SIDED|95.0|-20.46|-9.13|||Mixed Models Analysis|||||-9.13|-20.46|<0.001
70994306|NCT03334396|141497429|SUPERIORITY||Odds Ratio (OR)|1.17||||0.874|TWO_SIDED|95.0|0.17|7.77|||Regression, Logistic|||||7.77|0.17|0.874
70994307|NCT03334396|141497429|SUPERIORITY||Odds Ratio (OR)|2.88||||0.176|TWO_SIDED|95.0|0.62|13.36|||Regression, Logistic|||||13.36|0.62|0.176
70994308|NCT03334396|141497429|SUPERIORITY||Odds Ratio (OR)|2.72||||0.201|TWO_SIDED|95.0|0.59|12.65|||Regression, Logistic|||||12.65|0.59|0.201
70994309|NCT03334396|141497430|SUPERIORITY||Mean Difference (Final Values)|-5.99|STANDARD_ERROR_OF_MEAN|2.88||0.039|TWO_SIDED|95.0|-11.67|-0.31|||Mixed Models Analysis|||||-0.31|-11.67|0.039
70994310|NCT03334396|141497430|SUPERIORITY||Mean Difference (Final Values)|-5.34|STANDARD_ERROR_OF_MEAN|2.8||0.058|TWO_SIDED|95.0|-10.86|0.18|||Mixed Models Analysis|||||0.18|-10.86|0.058
70994311|NCT03334396|141497430|SUPERIORITY||Mean Difference (Final Values)|-11.16|STANDARD_DEVIATION|2.63|<|0.001|TWO_SIDED|95.0|-16.33|-5.98|||Mixed Models Analysis|||||-5.98|-16.33|<0.001
70994312|NCT03334396|141497431|SUPERIORITY|||||||0.067|||||||Fisher Exact|||||||0.067
70994313|NCT03334396|141497431|SUPERIORITY|||||||0.799|||||||Fisher Exact|||||||0.799
71099356|NCT01539525|141707536|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.749||||0.49|TWO_SIDED|95.0|0.205|2.732|||Regression, Logistic||Odds ratio estimate is for Motivational Interview- Computer vs. Treatment as Usual|||2.732|0.205|0.490
70994314|NCT03334396|141497431|SUPERIORITY|||||||0.782|||||||Fisher Exact|||||||0.782
71040137|NCT01540045|141588325|SUPERIORITY_OR_OTHER_LEGACY|||||||0.213|TWO_SIDED|||||clinically significant|Wilcoxon (Mann-Whitney)|||change in fatigue scale of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire||||0.213
71040138|NCT01540045|141588325|SUPERIORITY_OR_OTHER_LEGACY|||||||0.595|TWO_SIDED|||||clinically significant|Wilcoxon (Mann-Whitney)|||change in appetite loss of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire||||0.595
71040139|NCT01540045|141588325|SUPERIORITY_OR_OTHER_LEGACY|||||||0.068|TWO_SIDED|||||clinically significant|Wilcoxon (Mann-Whitney)|||change in constipation scale of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire||||0.068
71099357|NCT01712074|141707538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.695|STANDARD_ERROR_OF_MEAN|0.8697||0.4256|TWO_SIDED|80.0|-0.424|1.814|||Mixed Models Analysis|||||1.814|-0.424|0.4256
71099358|NCT01712074|141707539|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.194|STANDARD_ERROR_OF_MEAN|1.7149||0.2027|TWO_SIDED|80.0|-0.013|4.401|||Mixed Models Analysis|||||4.401|-0.013|0.2027
71099359|NCT02474901|141707564|EQUIVALENCE|Looked for statistically-significant difference in numbers of adverse events between the two groups, used a p-value of 0.05 as the cutoff value for significance.|||||<|0.05|||||||Chi-squared, Corrected|Groups were compared with Yates-corrected chi-square test or Fisher exact test for binary or categorical variables.||||||<0.05
70994315|NCT03334396|141497432|SUPERIORITY||Mean Difference (Final Values)|-19.25|STANDARD_ERROR_OF_MEAN|7.33||0.009|TWO_SIDED|95.0|-33.69|-4.81|||Mixed Models Analysis|||||-4.81|-33.69|0.009
70994316|NCT03334396|141497432|SUPERIORITY||Mean Difference (Final Values)|-17.39|STANDARD_ERROR_OF_MEAN|7.13||0.015|TWO_SIDED|95.0|-31.43|-3.35|||Mixed Models Analysis|||||-3.35|-31.43|0.015
70994317|NCT03334396|141497432|SUPERIORITY||Mean Difference (Final Values)|-24.5|STANDARD_ERROR_OF_MEAN|6.71|<|0.001|TWO_SIDED|95.0|-37.71|-11.3|||Mixed Models Analysis|||||-11.30|-37.71|<0.001
70994318|NCT03334396|141497433|SUPERIORITY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|1.19||0.028|TWO_SIDED|95.0|-4.98|-0.29|||Mixed Models Analysis|||||-0.29|-4.98|0.028
70994319|NCT03334396|141497433|SUPERIORITY||Mean Difference (Final Values)|-3.58|STANDARD_ERROR_OF_MEAN|1.17||0.003|TWO_SIDED|95.0|-5.89|-1.27|||Mixed Models Analysis|||||-1.27|-5.89|0.003
70994320|NCT03334396|141497433|SUPERIORITY||Mean Difference (Final Values)|-5.16|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-7.33|-2.99|||Mixed Models Analysis|||||-2.99|-7.33|<0.001
70994321|NCT03334396|141497434|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.15||0.069|TWO_SIDED|95.0|-0.56|0.02|||Mixed Models Analysis|||||0.02|-0.56|0.069
70994322|NCT03334396|141497434|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.15||0.066|TWO_SIDED|95.0|-0.56|0.02|||Mixed Models Analysis|||||0.02|-0.56|0.066
70994323|NCT03334396|141497434|SUPERIORITY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.73|-0.19|||Mixed Models Analysis|||||-0.19|-0.73|<0.001
70994324|NCT03334396|141497435|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.43||0.305|TWO_SIDED|95.0|-1.3|0.41|||Mixed Models Analysis|||HADS Anxiety||0.41|-1.30|0.305
71040140|NCT01540045|141588326|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
70994325|NCT03334396|141497435|SUPERIORITY||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.42||0.029|TWO_SIDED|95.0|-1.77|-0.1|||Mixed Models Analysis|||HADS Anxiety||-0.10|-1.77|0.029
70994326|NCT03334396|141497435|SUPERIORITY||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|0.4||0.004|TWO_SIDED|95.0|-1.93|-0.36|||Mixed Models Analysis|||HADS Anxiety||-0.36|-1.93|0.004
70994327|NCT03334396|141497435|SUPERIORITY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.43||0.113|TWO_SIDED|95.0|-1.51|0.16|||Mixed Models Analysis|||HADS Depression||0.16|-1.51|0.113
70994328|NCT03334396|141497435|SUPERIORITY||Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|0.42||0.014|TWO_SIDED|95.0|-1.85|-0.22|||Mixed Models Analysis|||HADS Depression||-0.22|-1.85|0.014
70994329|NCT03334396|141497435|SUPERIORITY||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|0.39||0.004|TWO_SIDED|95.0|-1.91|-0.37|||Mixed Models Analysis|||HADS Depression||-0.37|-1.91|0.004
70994330|NCT03334396|141497436|SUPERIORITY||Mean Difference (Final Values)|-2.17|STANDARD_ERROR_OF_MEAN|0.89||0.015|TWO_SIDED|95.0|-3.92|-0.42|||Mixed Models Analysis|||||-0.42|-3.92|0.015
70994331|NCT03334396|141497436|SUPERIORITY||Mean Difference (Final Values)|-1.84|STANDARD_ERROR_OF_MEAN|0.87||0.036|TWO_SIDED|95.0|-3.56|-0.12|||Mixed Models Analysis|||||-0.12|-3.56|0.036
70994332|NCT03334396|141497436|SUPERIORITY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|0.82|<|0.001|TWO_SIDED|95.0|-5.91|-2.69|||Mixed Models Analysis|||||-2.69|-5.91|<0.001
70994333|NCT03334396|141497437|SUPERIORITY||Mean Difference (Final Values)|-4.05|STANDARD_ERROR_OF_MEAN|2.7||0.136|TWO_SIDED|95.0|-9.39|1.29|||Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline||1.29|-9.39|0.136
70994334|NCT03334396|141497437|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|2.76||0.898|TWO_SIDED|95.0|-5.81|5.1|||Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline||5.10|-5.81|0.898
70994335|NCT03334396|141497437|SUPERIORITY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|2.49||0.174|TWO_SIDED|95.0|-8.32|1.52|||Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline||1.52|-8.32|0.174
70994336|NCT03334396|141497437|SUPERIORITY||Mean Difference (Final Values)|-6.86|STANDARD_ERROR_OF_MEAN|4.19||0.104|TWO_SIDED|95.0|-15.13|1.41|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline||1.41|-15.13|0.104
70994337|NCT03334396|141497437|SUPERIORITY||Mean Difference (Final Values)|-8.64|STANDARD_ERROR_OF_MEAN|4.28||0.045|TWO_SIDED|95.0|-17.09|-0.19|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline||-0.19|-17.09|0.045
70994338|NCT03334396|141497437|SUPERIORITY||Mean Difference (Final Values)|-12.28|STANDARD_ERROR_OF_MEAN|3.9||0.002|TWO_SIDED|95.0|-19.97|-4.59|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline||-4.59|-19.97|0.002
70994339|NCT03334396|141497437|SUPERIORITY||Mean Difference (Final Values)|-8.66|STANDARD_ERROR_OF_MEAN|4.67||0.066|TWO_SIDED|95.0|-17.89|0.57|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline||0.57|-17.89|0.066
70994340|NCT03334396|141497437|SUPERIORITY||Mean Difference (Final Values)|-6.49|STANDARD_ERROR_OF_MEAN|4.76||0.175|TWO_SIDED|95.0|-15.89|2.91|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline||2.91|-15.89|0.175
70994341|NCT03334396|141497437|SUPERIORITY||Mean Difference (Final Values)|-11.28|STANDARD_ERROR_OF_MEAN|4.34||0.01|TWO_SIDED|95.0|-19.84|-2.72|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline||-2.72|-19.84|0.010
70994342|NCT03334396|141497437|SUPERIORITY||Mean Difference (Final Values)|-7.31|STANDARD_ERROR_OF_MEAN|3.36||0.03|TWO_SIDED|95.0|-13.93|-0.7|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline||-0.70|-13.93|0.030
70994343|NCT03334396|141497437|SUPERIORITY||Mean Difference (Final Values)|-5.13|STANDARD_ERROR_OF_MEAN|3.31||0.122|TWO_SIDED|95.0|-11.65|1.39|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline||1.39|-11.65|0.122
70994344|NCT03334396|141497437|SUPERIORITY||Mean Difference (Final Values)|-16.52|STANDARD_ERROR_OF_MEAN|3.11|<|0.001|TWO_SIDED|95.0|-22.64|-10.41|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline||-10.41|-22.64|<0.001
70994345|NCT03334396|141497438|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.061|TWO_SIDED|95.0|0.0|0.08|||Mixed Models Analysis|||Health State Index Score (US algorithm)||0.08|-0.00|0.061
70994346|NCT03334396|141497438|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.06|TWO_SIDED|95.0|0.0|0.08|||Mixed Models Analysis|||Health State Index Score (US algorithm)||0.08|-0.00|0.060
70994347|NCT03334396|141497438|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|95.0|0.04|0.12|||Mixed Models Analysis|||Health State Index Score (US algorithm)||0.12|0.04|<0.001
70994348|NCT03334396|141497438|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.046|TWO_SIDED|95.0|0.0|0.11|||Mixed Models Analysis|||Health State Index Score (UK Algorithm)||0.11|0.00|0.046
70994349|NCT03334396|141497438|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.059|TWO_SIDED|95.0|0.0|0.11|||Mixed Models Analysis|||Health State Index Score (UK Algorithm)||0.11|-0.00|0.059
70994350|NCT03334396|141497438|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|0.06|0.16|||Mixed Models Analysis|||Health State Index Score (UK algorithm)||0.16|0.06|<0.001
70994351|NCT03334396|141497439|SUPERIORITY||Mean Difference (Final Values)|2.97|STANDARD_ERROR_OF_MEAN|3.21||0.356|TWO_SIDED|95.0|-3.36|9.3|||Mixed Models Analysis|||EQ-5D-5L VAS Score||9.30|-3.36|0.356
70994352|NCT03334396|141497439|SUPERIORITY||Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|3.13||0.668|TWO_SIDED|95.0|-4.81|7.5|||Mixed Models Analysis|||EQ-5D-5L VAS Score||7.50|-4.81|0.668
70994353|NCT03334396|141497439|SUPERIORITY||Mean Difference (Final Values)|7.05|STANDARD_ERROR_OF_MEAN|2.95||0.017|TWO_SIDED|95.0|1.25|12.86|||Mixed Models Analysis|||EQ-5D-5L VAS Score||12.86|1.25|0.017
70994354|NCT03334396|141497440|SUPERIORITY||Odds Ratio (OR)|1.38||||0.603|TWO_SIDED|95.0|0.41|4.71|||Regression, Logistic|||||4.71|0.41|0.603
70994355|NCT03334396|141497440|SUPERIORITY||Odds Ratio (OR)|4.08||||0.006|TWO_SIDED|95.0|1.5|11.12|||Regression, Logistic|||||11.12|1.50|0.006
70994356|NCT03334396|141497440|SUPERIORITY||Odds Ratio (OR)|4.72||||0.002|TWO_SIDED|95.0|1.78|12.55|||Regression, Logistic|||||12.55|1.78|0.002
70994357|NCT00592553|141497456|OTHER||Least Square (LS) Mean Difference|-30.52|STANDARD_ERROR_OF_MEAN|42.68||0.4756|TWO_SIDED|95.0|-114.8|53.75|||Mixed Models Analysis|||Analysis was performed using mixed model for repeated measures (MMRM) method including rank transformed 6MWD as the dependent variable; and rank transformed baseline 6MWD, treatment, visit, age (less than \[\<\] 9 years versus \[vs.\] greater than or equal to \[\>=\] 9 years) and corticosteroid use (yes vs. no) stratification factors, and interaction between treatment and visit as independent variables.||53.75|-114.8|0.4756
70994358|NCT00592553|141497456|OTHER||LS Mean Difference|62.65|STANDARD_ERROR_OF_MEAN|43.21||0.149|TWO_SIDED|95.0|-22.66|147.96|||Mixed Models Analysis|||Analysis was performed using MMRM method including rank transformed 6MWD as the dependent variable; and rank transformed baseline 6MWD, treatment, visit, age (\< 9 years vs. \>= 9 years) and corticosteroid use (yes vs. no) stratification factors, and interaction between treatment and visit as independent variables.||147.96|-22.66|0.1490
70994359|NCT01283997|141497492|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.54|TWO_SIDED|95.0|-0.13|0.24|||Wilcoxon (Mann-Whitney)|||Difference in the measurements for touch by the fingertip||0.24|-0.13|0.54
70994360|NCT01283997|141497492|OTHER||Mean Difference (Final Values)|0.05||||0.6|TWO_SIDED|95.0|-0.13|0.23|||Wilcoxon (Mann-Whitney)|||Difference in the measurements for touch by the palm||0.23|-0.13|0.60
71099360|NCT02792257|141707582|SUPERIORITY||Difference in slopes|-0.74|STANDARD_ERROR_OF_MEAN|0.3||0.015|TWO_SIDED|95.0|-1.328|-0.152|||Regression, Linear||standard error NOT standard error of the mean|Efficacy is assessed by fitting a longitudinal linear GEE model with the co primary outcomes and with time, treatment arm, and their interaction. Analyses are adjusted for site and for use of antidepressants and antipsychotics at baseline. The treatment by week interaction is the coefficient of interest and represents the difference in change in outcome per week between the two arms.||-0.152|-1.328|.015
70994361|NCT01283997|141497492|OTHER||Mean Difference (Final Values)|-0.12||||0.37|TWO_SIDED|95.0|-0.4|0.15|||Wilcoxon (Mann-Whitney)|||Difference in the measurements for touch by the forearm||0.15|-0.40|0.37
70994362|NCT01283997|141497493|OTHER||Mean Difference (Final Values)|-0.73||||0.56|TWO_SIDED|95.0|-2.06|0.59|||Wilcoxon (Mann-Whitney)|||Difference in Numbness severity at baseline and week 10.||0.59|-2.06|0.56
70994363|NCT01337167|141497516|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|9.68|||<|0.001|TWO_SIDED|95.0|4.83|14.83|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||Non-inferiority for titer \>=1.0 μg/mL||14.83|4.83|<0.001
70994364|NCT01337167|141497516|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (V419 - Ctrl)|4.87|||<|0.001|TWO_SIDED|95.0|2.23|8.14|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||Non-inferiority for titer \>=0.15 μg/mL||8.14|2.23|<0.001
70994365|NCT01337167|141497516|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419-Ctrl)|4.87|||<|0.001|TWO_SIDED|95.0|2.23|8.14|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||Secondary Analysis: Non-inferiority for titer \>=0.15 μg/mL||8.14|2.23|<0.001
70994366|NCT01337167|141497517|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|0.84|||<|0.001|TWO_SIDED|95.0|-0.35|2.74|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||2.74|-0.35|<0.001
70994367|NCT01337167|141497518|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|-3.84||||0.002|TWO_SIDED|95.0|-8.02|0.66|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||0.66|-8.02|0.002
70994368|NCT01337167|141497519|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (V419 - Ctrl)|0.39|||<|0.001|TWO_SIDED|95.0|-0.28|1.74|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||1.74|-0.28|<0.001
70994369|NCT01337167|141497520|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|-0.33|||<|0.001|TWO_SIDED|95.0|-1.8|1.6|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||1.60|-1.80|<0.001
70994370|NCT01337167|141497521|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|-4.7||||0.001|TWO_SIDED|95.0|-8.14|-0.97|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||-0.97|-8.14|0.001
70994371|NCT01337167|141497522|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|-2.67|||<|0.001|TWO_SIDED|95.0|-7.27|2.23|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||2.23|-7.27|<0.001
70994372|NCT01337167|141497523|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|4.05|||<|0.001|TWO_SIDED|95.0|0.23|8.28|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||8.28|0.23|<0.001
70994373|NCT01337167|141497524|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (V419 - Ctrl)|1.76|||<|0.001|TWO_SIDED|95.0|0.85|3.59|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||3.59|0.85|<0.001
70994374|NCT01337167|141497524|SUPERIORITY_OR_OTHER||Response Rate|100.0|||<|0.001|TWO_SIDED|95.0|99.54|100.0|||Clopper and Pearson|Acceptability requires that the lower bound of the 2-sided 95% CI of the response rate is \>=90||||100.00|99.54|<0.001
70994375|NCT01337167|141497525|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (V419 - Ctrl)|0.26|||<|0.001|TWO_SIDED|95.0|-0.22|1.42|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||1.42|-0.22|<0.001
70994376|NCT01337167|141497525|SUPERIORITY_OR_OTHER||Response Rate|100.0|||<|0.001|TWO_SIDED|95.0|99.54|100.0|||Clopper and Pearson|Acceptability requires that the lower bound of the 2-sided 95% CI of the response rate is \>=90||||100.00|99.54|<0.001
70994377|NCT01337167|141497526|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (V419 - Ctrl)|0.25|||<|0.001|TWO_SIDED|95.0|-0.24|1.41|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||1.41|-0.24|<0.001
70994378|NCT01337167|141497526|SUPERIORITY_OR_OTHER||Response Rate|100.0|||<|0.001|TWO_SIDED|95.0|99.53|100.0|||Clopper and Pearson|Acceptability requires that the lower bound of the 2-sided 95% CI of the response rate is \>=90||||100.00|99.53|<0.001
70994379|NCT01337167|141497527|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the Geometric Mean Concentration (GMC) ratio is \>=0.67|GMC Ratio (V419/Control)|1.28|||<|0.001|TWO_SIDED|95.0|1.2|1.38|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.38|1.20|<0.001
70994380|NCT01337167|141497528|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|0.64||||0.786|TWO_SIDED|95.0|0.59|0.7|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||0.70|0.59|0.786
70994381|NCT01337167|141497529|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|0.83|||<|0.001|TWO_SIDED|95.0|0.73|0.95|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||0.95|0.73|<0.001
70994382|NCT01337167|141497530|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|1.28|||<|0.001|TWO_SIDED|95.0|1.15|1.42|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.42|1.15|<0.001
70994383|NCT01337167|141497531|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|1.88|||<|0.001|TWO_SIDED|95.0|0.39|4.18|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||4.18|0.39|<0.001
70994384|NCT01337167|141497532|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|1.3|||<|0.001|TWO_SIDED|95.0|-1.67|4.78|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||4.78|-1.67|<0.001
70994385|NCT01337167|141497533|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|-0.41|||<|0.001|TWO_SIDED|95.0|-3.46|3.1|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||3.10|-3.46|<0.001
70994386|NCT01337167|141497534|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|6.18|||<|0.001|TWO_SIDED|95.0|3.26|9.78|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||9.78|3.26|<0.001
70994387|NCT01337167|141497535|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|1.4|||<|0.001|TWO_SIDED|95.0|1.28|1.52|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.52|1.28|<0.001
70994388|NCT01337167|141497536|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|1.0|||<|0.001|TWO_SIDED|95.0|0.91|1.1|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.10|0.91|<0.001
70994389|NCT01337167|141497537|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|0.78||||0.014|TWO_SIDED|95.0|0.68|0.89|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||0.89|0.68|0.014
70994390|NCT01337167|141497538|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|1.58|||<|0.001|TWO_SIDED|95.0|1.41|1.78|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.78|1.41|<0.001
70994391|NCT01337167|141497539|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|1.62|||<|0.001|TWO_SIDED|95.0|1.32|1.98|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.98|1.32|<0.001
70994392|NCT01337167|141497540|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|1.02|||<|0.001|TWO_SIDED|95.0|0.83|1.24|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.24|0.83|<0.001
70994393|NCT01337167|141497544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.1|||||TWO_SIDED|95.0|-18.4|-7.7|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, all routes \<38°C||-7.7|-18.4|
70994394|NCT01337167|141497544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|||||TWO_SIDED|95.0|0.5|9.5|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, all routes \>=38°C and \<38.5°C||9.5|0.5|
70994395|NCT01337167|141497544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|||||TWO_SIDED|95.0|2.8|11.2|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, all routes \>=38.5°C and \<39.5°C||11.2|2.8|
70994396|NCT01337167|141497544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0|-0.6|2.2|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, all routes \>=39.5°C||2.2|-0.6|
70994397|NCT01337167|141497544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.2|||||TWO_SIDED|95.0|-18.6|-7.7|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, rectal \<38°C||-7.7|-18.6|
70994398|NCT01337167|141497544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.5|||||TWO_SIDED|95.0|1.9|10.8|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, rectal \>=38°C and \<38.5°C||10.8|1.9|
71099361|NCT02792257|141707583|SUPERIORITY||Difference in slopes|-1.26|STANDARD_ERROR_OF_MEAN|0.75||0.094|TWO_SIDED|95.0|-2.73|0.21|||Regression, Linear||standard error not standard error of the mean|Efficacy is assessed by fitting a longitudinal linear GEE model with the co primary outcomes and with time, treatment arm, and their interaction. Analyses are adjusted for site and for use of antidepressants and antipsychotics at baseline. The treatment by week interaction is the coefficient of interest and represents the difference in change in outcome per week between the two arms.||0.21|-2.73|.094
71099362|NCT02792257|141707584|SUPERIORITY||Incident rate ratio|1.14|STANDARD_ERROR_OF_MEAN|0.26||0.57|TWO_SIDED|95.0|0.73|1.79|||Regression, Logistic|The original analytic plan called for a logistic regression of ever/never SAE as a function of treatment assignment.|not standard error of the mean just standard error.|||1.79|0.73|.57
70994399|NCT01337167|141497544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|||||TWO_SIDED|95.0|2.4|10.7|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, rectal \>=38.5°C and \<39.5°C||10.7|2.4|
70994400|NCT01337167|141497544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|-0.3|2.4|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, rectal \>=39.5°C||2.4|-0.3|
70994401|NCT00884221|141497569|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis (H0) was tested against the alternative by constructing a two-sided 95% confidence interval for the difference in ongoing pregnancy rates. If the lower-limit of the 95% confidence interval was greater than the non-inferiority limit (-10.0%), the null hypothesis was rejected and it would be claimed that highly purified menotrophin was non-inferior to recombinant FSH with respect to ongoing pregnancy rate in a single fresh treatment cycle following a GnRH antagonist protocol.|Difference in pregnancy rates, ITT|2.2||||0.499|TWO_SIDED|95.0|-4.2|8.6||Since there was only one primary endpoint, no adjustment for multiplicity was needed for the primary analysis.|Sign test|A two-sided 95% confidence interval for the difference in ongoing pregnancy rates was made. The CI was based on a normal approximation.|Difference tested: highly purified menotrophin-recombinant FSH, ITT analysis set|"The non-inferiority hypothesis to be tested for the primary endpoint was:~H0: π MENOPUR - π recombinant FSH ≤ -10.0% against the alternative H1: π MENOPUR - π recombinant FSH \> -10.0%,~where π MENOPUR and π recombinant FSH denote the ongoing pregnancy rate after treatment with MENOPUR and recombinant FSH, respectively, in a single fresh treatment cycle following a GnRH antagonist protocol."||8.6|-4.2|0.499
70994402|NCT00884221|141497570|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Estradiol||||<0.001
70994403|NCT00884221|141497571|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||FSH||||<0.001
70994404|NCT00884221|141497572|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Free Androgen Index||||<0.001
70994405|NCT00884221|141497573|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Luteinizing hormone||||<0.001
71040141|NCT01540045|141588327|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|TWO_SIDED|||||clinically significant|Wilcoxon (Mann-Whitney)|||change in peripheral neuropathy scale of quality of life between \> ó = compared to \< umami recognition threshold after chemotherapy by EORT questionnaire||||0.240
71040142|NCT01540045|141588328|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change in status global of quality of life between \> ó = compared to \< umami recognition threshold after chemotherapy by EORT questionnaire||||0.036
71099363|NCT00553475|141707585|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63||||0.0075||95.0|-1.09|-0.17|||ANCOVA|Treatment groups and the CLcr strata as factors and baseline values as covariates.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.17|-1.09|0.0075
70994406|NCT00884221|141497574|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Progesterone||||0.630
71040143|NCT01540045|141588329|SUPERIORITY_OR_OTHER_LEGACY|||||||0.312|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.||||0.312
71040144|NCT01540045|141588330|SUPERIORITY_OR_OTHER_LEGACY|||||||0.608|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.||||0.608
71040145|NCT01540045|141588331|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.||||0.035
71040146|NCT01540045|141588332|SUPERIORITY_OR_OTHER_LEGACY|||||||0.402|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.||||0.402
71040147|NCT01540045|141588333|SUPERIORITY_OR_OTHER_LEGACY|||||||0.109|TWO_SIDED||||||McNemar|||for the paired analysis of taste acuity, we used Mc Nemar test for dividing into high and low sensibility to umami, bitter and sweet tastes.||||0.109
71099364|NCT00553475|141707585|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74||||0.0254||95.0|-1.39|-0.09|||ANCOVA|Treatment groups and the CLcr strata as factors and baseline values as covariates.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.09|-1.39|0.0254
71099365|NCT00553475|141707586|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28||||0.8731||95.0|-3.67|3.12|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.12|-3.67|0.8731
71099366|NCT00553475|141707586|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.16||||0.6337||95.0|-3.62|5.94|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.94|-3.62|0.6337
71099367|NCT00553475|141707587|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.1||||0.4398||95.0|-7.44|3.24|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.24|-7.44|0.4398
71099368|NCT00553475|141707587|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41||||0.9153||95.0|-7.96|7.14|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||7.14|-7.96|0.9153
71099369|NCT00553475|141707588|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.5||||0.4873||95.0|-2.75|5.76|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.76|-2.75|0.4873
71099370|NCT00553475|141707588|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.56||||0.4008||95.0|-3.42|8.53|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||8.53|-3.42|0.4008
71099371|NCT00553475|141707589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.98||||0.5372||95.0|-2.13|4.09|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||4.09|-2.13|0.5372
71099372|NCT00553475|141707589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.09||||0.348||95.0|-2.29|6.47|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||6.47|-2.29|0.3480
71099373|NCT00553475|141707590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.06||||0.0544||95.0|-0.1|10.21|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||10.21|-0.10|0.0544
71099374|NCT00553475|141707590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.15||||0.0278||95.0|0.89|15.42|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||15.42|0.89|0.0278
71099375|NCT00553475|141707591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.92||||0.7394||95.0|-4.52|6.37|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||6.37|-4.52|0.7394
71099376|NCT00553475|141707591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.22||||0.5712||95.0|-5.49|9.93|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||9.93|-5.49|0.5712
71099377|NCT00553475|141707592|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.67||||0.0058||95.0|-1.14|-0.19|||ANCOVA|Treatment groups as factors and baseline values as covariates||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.19|-1.14|0.0058
71099378|NCT00553475|141707592|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64||||0.0333||95.0|-1.23|-0.05|||ANCOVA|Treatment groups as factors and baseline values as covariates||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.05|-1.23|0.0333
71099379|NCT00553475|141707593|SUPERIORITY_OR_OTHER_LEGACY|||||||0.153||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Significance level of 0.05 was used.||||0.153
71099380|NCT00553475|141707593|SUPERIORITY_OR_OTHER_LEGACY|||||||0.059||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Significance level of 0.05 was used.||||0.059
71099381|NCT00553475|141707594|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43||||0.0287||95.0|-0.82|-0.05|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.05|-0.82|0.0287
71099382|NCT00553475|141707594|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.75||||0.0073||95.0|-1.29|-0.2|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.20|-1.29|0.0073
71099383|NCT00553475|141707595|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.61||||0.0021||95.0|-1.0|-0.22|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.22|-1.00|0.0021
71099384|NCT00553475|141707595|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.23|||<|0.0001||95.0|-1.78|-0.69|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.69|-1.78|<0.0001
71099385|NCT00553475|141707596|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.0026||95.0|-0.99|-0.21|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.21|-0.99|0.0026
71008851|NCT02194699|141525390|SUPERIORITY||Least square (LS) Mean difference|1.86||||0.6033|TWO_SIDED|95.0|-5.16|8.88|||Repeated measures analysis||Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of % change from baseline in pre-dose/pre-BD FEV1 at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~Restricted maximum likelihood (REML) based repeated measures analysis on patients with a baseline pre-dose/pre-BD FEV1 assessment.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||8.88|-5.16|0.6033
71040148|NCT01540045|141588334|SUPERIORITY_OR_OTHER_LEGACY|||||||0.092|TWO_SIDED||||||McNemar|||for the paired analysis of taste acuity, we used Mc Nemar test for dividing into high and low sensibility to umami, bitter and sweet tastes.||||0.092
71040149|NCT01540045|141588335|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022|TWO_SIDED||||||McNemar|||We divide dilutions in two groups and dichotomized the patients into high and low sensibility to bitter taste. (PERCEPTION)||||0.022
71040150|NCT01898598|141588347|SUPERIORITY_OR_OTHER||Difference in Clinical Response Rates|-21.8|||||TWO_SIDED|95.0|-71.6|32.1||||||The 95 % confidence interval (CI) for the difference in response rates was computed using the exact unconditional confidence limits method.||32.1|-71.6|
71040151|NCT01898598|141588348|SUPERIORITY_OR_OTHER||Percentage Difference|-40.0|||||TWO_SIDED|95.0|-85.3|14.2||||||||14.2|-85.3|
71040152|NCT01499160|141588365|OTHER|Not done due to low accrual||||||||||||Not done due to low accrual|Not done due to low accrual|Not done due to low accrual||Not done due to low accrual|Not done due to low accrual|||
71040153|NCT00688844|141588382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.655574|STANDARD_DEVIATION|8.060658||0.692782|||||||t-test, 2 sided|||Objective was to evaluate BMI across one year in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||0.692782
71040154|NCT00688844|141588383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005401|STANDARD_DEVIATION|0.0243|<|0.001|||||||t-test, 2 sided|||Objective was to evaluate total body bone mineral density (BMD) one year via DXA in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||<0.001
71040155|NCT00688844|141588384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.419224|STANDARD_DEVIATION|3.4666||0.017941|||||||t-test, 2 sided|||Objective was to evaluate % lean mass across one year via DXA in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||0.017941
71099386|NCT00553475|141707596|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.13|||<|0.0001||95.0|-1.69|-0.58|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.58|-1.69|<0.0001
71040156|NCT00688844|141588385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.208889|STANDARD_DEVIATION|3.51967||0.026009|||||||t-test, 2 sided|||Objective was to evaluate % fat mass across one year via DXA in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||0.026009
71040157|NCT00688844|141588386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-67.5187|STANDARD_DEVIATION|362.9412||0.303864|||||||t-test, 2 sided|||Objective was to evaluate plasma phenylalanine across one year in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||0.303864
71040158|NCT00688844|141588387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9549|STANDARD_DEVIATION|20.10814||0.00088|||||||t-test, 2 sided|||Objective was to evaluate protein intake (grams per day) across one year in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||0.00088
71040159|NCT00688844|141588388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131676|STANDARD_DEVIATION|0.797247||0.3811|||||||t-test, 2 sided|||Objective was to evaluate dietary phenylalanine intake across one year in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||0.3811
71040160|NCT01374451|141588390|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.991||||0.488|TWO_SIDED|95.0|0.636|1.543|||Log Rank|||||1.543|0.636|0.488
71040161|NCT03201003|141588434|SUPERIORITY||Risk Difference (RD)|56.0|||<|0.0001|TWO_SIDED|95.0|44.1|65.2|||Fisher Exact|||Treatment difference at 1000 mg||65.2|44.1|<0.0001
71040162|NCT03201003|141588435|SUPERIORITY||Risk Difference (RD)|58.9|||<|0.0001|TWO_SIDED|95.0|44.2|69.3|||Fisher Exact|||Treatment difference at 600 mg||69.3|44.2|<0.0001
71040163|NCT03201003|141588436|SUPERIORITY||Risk Difference (RD)|57.2|||<|0.0001|TWO_SIDED|95.0|41.2|69.1|||Fisher Exact|||Treatment difference at 300 mg||69.1|41.2|<0.0001
71040164|NCT03201003|141588437|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic (with equally spaced scores) stratified by country||Treatment difference in Maximum Severity||||<0.0001
71040165|NCT00834613|141588438|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.45||||||90.0|99.87|107.15|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.15|99.87|
71099387|NCT00553475|141707597|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64||||0.0012||95.0|-1.03|-0.25|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.25|-1.03|0.0012
71040166|NCT00834613|141588439|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.63||||||90.0|95.21|100.11|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.11|95.21|
71040167|NCT00834613|141588440|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.63||||||90.0|95.22|100.1|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.1|95.22|
70994407|NCT00884221|141497575|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis (H0) was tested against the alternative by constructing a two-sided 95% confidence interval for the difference in ongoing pregnancy rates. If the lower-limit of the 95% confidence interval was greater than the non-inferiority limit (-10.0%), the null hypothesis was rejected and it would be claimed that highly purified menotrophin was non-inferior to recombinant FSH with respect to ongoing pregnancy rate in a single fresh treatment cycle following a GnRH antagonist protocol.|Difference in pregnancy rates, PP|3.0||||0.387|TWO_SIDED|95.0|-3.8|9.8||Since there was only one primary endpoint, no adjustment for multiplicity was needed for the primary analysis.|Sign test|A two-sided 95% confidence interval for the difference in ongoing pregnancy rates was made. The CI was based on a normal approximation.|Difference tested: highly purified menotrophin - recombinant FSH, PP|"The non-inferiority hypothesis to be tested for the primary endpoint was:~H0: π MENOPUR - π recombinant FSH ≤ -10.0% against the alternative H1: π MENOPUR - π recombinant FSH \> -10.0%,~where π MENOPUR and π recombinant FSH denote the ongoing pregnancy rate after treatment with MENOPUR and recombinant FSH, respectively, in a single fresh treatment cycle following a GnRH antagonist protocol."||9.8|-3.8|0.387
70994408|NCT00884221|141497576|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Prolactin||||0.047
70994409|NCT00884221|141497577|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Sex hormone binding globulin||||0.009
70994410|NCT00884221|141497578|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Testosterone||||<0.001
70994411|NCT00884221|141497579|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatment groups of the average number of follicles \>= 12 mm on the last stimulation day||||0.025
70994412|NCT00884221|141497579|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatment groups of the average number of follicles 12-14 mm on the last stimulation day||||0.024
70994413|NCT00884221|141497579|SUPERIORITY_OR_OTHER|||||||0.728||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatment groups of the average number of follicles 15-16 mm on the last stimulation day||||0.728
70994414|NCT00884221|141497579|SUPERIORITY_OR_OTHER|||||||0.285||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatment groups of the average number of follicles \>=17 mm on the last stimulation day||||0.285
70994415|NCT00884221|141497580|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|Only participants who underwent the oocyte retrieval procedure were included in the analysis||Treatments were compared using the Wilcoxon test for the average number of oocytes retrieved.||||<0.001
70994416|NCT00884221|141497581|SUPERIORITY_OR_OTHER|||||||0.969||95.0|||||Wilcoxon (Mann-Whitney)|Only participants who had oocytes retrieved were included in the analysis.||||||0.969
70994417|NCT00884221|141497582|SUPERIORITY_OR_OTHER|||||||0.406||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status 1 / 2pn||||0.406
70994418|NCT00884221|141497582|SUPERIORITY_OR_OTHER|||||||0.232||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status 2 / 2pn||||0.232
70994419|NCT00884221|141497582|SUPERIORITY_OR_OTHER|||||||0.412||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status 3 / 2pn||||0.412
70994420|NCT00884221|141497582|SUPERIORITY_OR_OTHER|||||||0.438||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status 4 / 2pn||||0.438
70994421|NCT00884221|141497582|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status 5 / 2pn||||0.390
70994422|NCT00884221|141497582|SUPERIORITY_OR_OTHER|||||||0.958||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status, inner cell mass grading and trophectoderm grading 4AA / 2pn||||0.958
70994423|NCT00884221|141497582|SUPERIORITY_OR_OTHER|||||||0.954||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status, inner cell mass grading and trophectoderm grading 5AA / 2pn||||0.954
70994424|NCT00884221|141497583|SUPERIORITY_OR_OTHER||Comparison of distributions|0.398||||0.398|TWO_SIDED|95.0|-3.6|9.1|||Wilcoxon (Mann-Whitney)|A two-sided 95% confidence interval for the difference in live birth rates was made. The CI was based on a normal approximation.|Estimated value is difference between highly purified menotrophin and recombinant FSH, ITT analysis set|||9.1|-3.6|0.398
71040168|NCT01994980|141588460|SUPERIORITY||||||<|0.01||||||This is a calculated p value.|Wilcoxon (Mann-Whitney)|||||||<0.01
71040169|NCT00096460|141588483|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Survival Probability|62.7|||||TWO_SIDED|95.0|43.8|89.6||||||||89.6|43.8|
71040170|NCT00096460|141588483|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Survival Probability|85.7||||||95.0|63.3|100.0||||||||100|63.3|
71040171|NCT00697619|141588508|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.370
71040172|NCT00697619|141588508|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71040173|NCT00697619|141588508|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.01
71040174|NCT04556734|141588542|OTHER|F-test|LS Mean Difference|-14.14||||0.2579|TWO_SIDED|95.0|-38.933|10.648|||Mixed Models Analysis|||Mixed model for repeated measurements (MMRM) was used for evaluation. The model included the treatment group, visit and treatment-by-visit interaction as fixed effects, disease duration and baseline SALT I score as covariates.||10.648|-38.933|0.2579
71040175|NCT04556734|141588542|OTHER|F-test|LS Mean Difference|-21.79||||0.0592|TWO_SIDED|95.0|-44.446|0.871|||Mixed Models Analysis|||MMRM was used for evaluation. The model included the treatment group, visit and treatment-by-visit interaction as fixed effects, disease duration and baseline SALT I score as covariates.||0.871|-44.446|0.0592
71040176|NCT04556734|141588543|OTHER|F-test|Least square (LS) Mean Difference|-9.23||||0.1283|TWO_SIDED|95.0|-21.217|2.748|||Mixed Models Analysis|||MMRM was used for evaluation. The model included the treatment group, visit and treatment-by-visit interaction as fixed effects, disease duration and baseline SALT I score as covariates.||2.748|-21.217|0.1283
70994425|NCT00884221|141497584|SUPERIORITY_OR_OTHER||Comparison of distributions|1.8||||0.686|TWO_SIDED|95.0|-5.6|9.2|||Wilcoxon (Mann-Whitney)|A two-sided 95% confidence interval for the difference in cumulative live birth rates was made. The CI was based on a normal approximation.|Estimated value is difference between highly purified menotrophin and recombinant FSH, ITT analysis set|||9.2|-5.6|0.686
70994426|NCT02757092|141497585|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
70994427|NCT02757092|141497586|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
70994428|NCT02757092|141497587|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
70994429|NCT02757092|141497588|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
70994430|NCT02757092|141497589|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
70994431|NCT02757092|141497590|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
71099388|NCT00553475|141707597|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.11|||<|0.0001||95.0|-1.67|-0.56|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.56|-1.67|<0.0001
71099389|NCT00553475|141707598|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.65||||0.0011||95.0|-1.04|-0.26|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.26|-1.04|0.0011
70994432|NCT02757092|141497591|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
70994433|NCT02757092|141497592|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
70994434|NCT02757092|141497593|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
70994435|NCT02757092|141497594|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
70994436|NCT02757092|141497595|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
70994437|NCT02757092|141497596|SUPERIORITY|||||||0.05|||||||Chi-squared|||Descriptive statistics were expressed as mean ± standard deviation or median and interquartile range depending on the nature and distribution of the variables||||0.05
70994438|NCT02757092|141497597|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
70994439|NCT02757092|141497598|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
70994440|NCT02757092|141497599|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71099390|NCT00553475|141707598|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.16|||<|0.0001||95.0|-1.72|-0.6|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.60|-1.72|<0.0001
70994441|NCT02757092|141497600|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
70994442|NCT02757092|141497602|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
70994443|NCT02757092|141497603|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
70994444|NCT02757092|141497604|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
70994445|NCT02757092|141497605|SUPERIORITY||||||<|0.05|||||||Chi-squared|||null hypothesis||||<0.05
70994446|NCT02757092|141497606|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
70994447|NCT02757092|141497607|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
70994448|NCT02757092|141497608|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
70994449|NCT02757092|141497609|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
70994450|NCT02757092|141497611|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
70994451|NCT02757092|141497612|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
70994452|NCT02757092|141497613|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
70994453|NCT01646398|141497617|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.3|||||TWO_SIDED|95.0|0.99|1.75||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.75|0.99|
70994454|NCT01646398|141497617|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.59|0.89||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||0.89|0.59|
70994455|NCT01646398|141497617|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.6|||||TWO_SIDED|95.0|1.96|3.44||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||3.44|1.96|
70994456|NCT01646398|141497617|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.9|||||TWO_SIDED|95.0|2.22|3.86||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||3.86|2.22|
70994457|NCT01646398|141497617|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.1|1.75||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.75|1.10|
70994458|NCT01646398|141497617|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.12|1.74||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.74|1.12|
70994459|NCT01646398|141497617|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.3|||||TWO_SIDED|95.0|1.59|3.24||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||3.24|1.59|
70994460|NCT01646398|141497617|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.77|1.23||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.23|0.77|
70994461|NCT01646398|141497617|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.1|||||TWO_SIDED|95.0|1.61|2.86||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||2.86|1.61|
70994462|NCT01646398|141497617|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.3|||||TWO_SIDED|95.0|1.81|2.92||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||2.92|1.81|
70994463|NCT01646398|141497617|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.0|||||TWO_SIDED|95.0|1.42|2.79||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||2.79|1.42|
70994464|NCT01646398|141497617|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.5|||||TWO_SIDED|95.0|1.84|3.49||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||3.49|1.84|
70994465|NCT01646398|141497618|SUPERIORITY_OR_OTHER||Difference in percentage|26.8|||||TWO_SIDED|95.0|19.3|34.0||||||Difference in proportions (13vPnC - 23vPS) expressed as a percentage presented along with exact, 2-sided 95%CI. Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.||34.0|19.3|
71040177|NCT04556734|141588543|OTHER|F-test|LS Mean Difference|-8.99||||0.1057|TWO_SIDED|95.0|-19.936|1.962|||Mixed Models Analysis|||MMRM was used for evaluation. The model included the treatment group, visit and treatment-by-visit interaction as fixed effects, disease duration and baseline SALT I score as covariates.||1.962|-19.936|0.1057
70994466|NCT01646398|141497619|SUPERIORITY_OR_OTHER||GMT Ratio|1.3|||||TWO_SIDED|95.0|0.99|1.75||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||1.75|0.99|
71040178|NCT04556734|141588544|OTHER||Response rate difference|11.5||||0.4067|TWO_SIDED|95.0|-14.22|37.31||P-values were based on the comparison of etrasimod versus placebo.|Cochran-Mantel-Haenszel||Clopper-Pearson method|\>= 30% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 2 mg and DB Treatment period: Placebo||37.31|-14.22|0.4067
71040179|NCT04556734|141588544|OTHER||Response rate difference|17.5||||0.2171|TWO_SIDED|95.0|-8.23|43.19||P-values were based on the comparison of etrasimod versus placebo.|Cochran-Mantel-Haenszel||Clopper-Pearson method|\>= 30% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 3 mg and DB Treatment period: Placebo||43.19|-8.23|0.2171
70994467|NCT01646398|141497619|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.59|0.89||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||0.89|0.59|
70994468|NCT01646398|141497619|SUPERIORITY_OR_OTHER||GMT Ratio|2.6|||||TWO_SIDED|95.0|1.96|3.44||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||3.44|1.96|
70994469|NCT01646398|141497619|SUPERIORITY_OR_OTHER||GMT Ratio|2.9|||||TWO_SIDED|95.0|2.22|3.86||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||3.86|2.22|
70994470|NCT01646398|141497619|SUPERIORITY_OR_OTHER||GMT Ratio|1.4|||||TWO_SIDED|95.0|1.1|1.75||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||1.75|1.10|
70994471|NCT01646398|141497619|SUPERIORITY_OR_OTHER||GMT Ratio|1.4|||||TWO_SIDED|95.0|1.12|1.74||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||1.74|1.12|
70994472|NCT01646398|141497619|SUPERIORITY_OR_OTHER||GMT Ratio|2.3|||||TWO_SIDED|95.0|1.59|3.24||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||3.24|1.59|
71099391|NCT00553475|141707599|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.79|||<|0.0001||95.0|-1.18|-0.4|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.40|-1.18|<0.0001
71040180|NCT04556734|141588544|OTHER||Response rate difference|-0.8||||0.9425|TWO_SIDED|95.0|-23.18|21.48||P-values were based on the comparison of etrasimod versus placebo.|Cochran-Mantel-Haenszel||Clopper-Pearson method|\>= 50% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 2 mg and DB Treatment period: Placebo||21.48|-23.18|0.9425
71099392|NCT00553475|141707599|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.12|||<|0.0001||95.0|-1.68|-0.56|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.56|-1.68|<0.0001
70994473|NCT01646398|141497619|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.77|1.23||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||1.23|0.77|
70994474|NCT01646398|141497619|SUPERIORITY_OR_OTHER||GMT Ratio|2.1|||||TWO_SIDED|95.0|1.61|2.86||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||2.86|1.61|
70994475|NCT01646398|141497619|SUPERIORITY_OR_OTHER||GMT Ratio|2.3|||||TWO_SIDED|95.0|1.81|2.92||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||2.92|1.81|
70994476|NCT01646398|141497619|SUPERIORITY_OR_OTHER||GMT Ratio|2.0|||||TWO_SIDED|95.0|1.42|2.79||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||2.79|1.42|
70994477|NCT01646398|141497619|SUPERIORITY_OR_OTHER||GMT Ratio|2.5|||||TWO_SIDED|95.0|1.84|3.49||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||3.49|1.84|
71099393|NCT00553475|141707600|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.72||||0.0003||95.0|-1.12|-0.33|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.33|-1.12|0.0003
70994478|NCT01646398|141497619|SUPERIORITY_OR_OTHER||GMT Ratio|3.1|||||TWO_SIDED|95.0|2.38|4.14||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 2.0.||4.14|2.38|
70994479|NCT01956240|141497636|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.51|STANDARD_DEVIATION|1.9|<|0.05|TWO_SIDED|95.0|||||ANOVA|A 1-way repeated measures ANOVA was used to assess for possible differences among evaluations in each group separately for pectoralis minor length.||||||<0.05
70994480|NCT01956240|141497637|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5.0|||>|0.05|TWO_SIDED|95.0|||||ANOVA|Separate 2-way repeated measures ANOVAs were used to test for interactions of angle x evaluation (1,2,3) and for main effects of evaluation.||||||>0.05
70994481|NCT00600028|141497641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0||||0.001|TWO_SIDED|95.0|||||Mixed Models Analysis||The values represents three months on each intervention|||||0.001
70994482|NCT00600028|141497642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0||||0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis||The values represents three months on each intervention|||||.0001
70994483|NCT03172481|141497643|OTHER|The primary efficacy analysis used a mixed-model repeated measures (MMRM) analysis on the full day laboratory classroom SKAMP-C scores from each time point as the dependent variable. The repeated measures model adjusted means (LS-means) for PRC-063 and placebo were compared statistically using a t-test with an overall 5% significance level to evaluate efficacy. The LS-means estimate an overall treatment effect across the entire 13-hour classroom evaluation.|||||<|0.0001|||||||ANOVA|||||||<0.0001
71040181|NCT04556734|141588544|OTHER||Response rate difference|8.9||||0.4959|TWO_SIDED|95.0|-15.19|32.94||P-values were based on the comparison of etrasimod versus placebo.|Cochran-Mantel-Haenszel||Clopper-Pearson method|\>= 50% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 3 mg and DB Treatment period: Placebo||32.94|-15.19|0.4959
70994484|NCT02928380|141497647|OTHER||Least square (LS) mean difference|-0.02||||0.0987|TWO_SIDED|95.0|-0.05|0.0|||ANOVA|ANOVA Model with weight of the peanut particle (food occlusion) as response variable, treatment and period as fixed effect.|Difference is first named treatment minus second named treatment is such that a negative difference favors the first named treatment.|H0: The mean mass of food particles retrieved from using a marketed denture adhesive with a flat ribbon nozzle is no different from using no adhesive H01: The mean mass of food particles retrieved from using a marketed denture adhesive with a flat ribbon nozzle is different from using no adhesive.||0.00|-0.05|0.0987
71099394|NCT00553475|141707600|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.09||||0.0002||95.0|-1.66|-0.52|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.52|-1.66|0.0002
71099395|NCT00553475|141707601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.67||||0.0008||95.0|-1.07|-0.28|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.28|-1.07|0.0008
70994485|NCT00664755|141497667|SUPERIORITY||Odds Ratio (OR)|2.77||||0.011|TWO_SIDED|95.0|1.17|6.59|||Regression, Logistic|||||6.59|1.17|0.011
70994486|NCT01840228|141497682|SUPERIORITY||Risk Ratio (RR)|1.1||||0.74|TWO_SIDED|95.0|0.63|1.91|||Chi-squared|||||1.91|0.63|0.74
70994487|NCT01840228|141497683|SUPERIORITY||Risk Ratio (RR)|0.43||||0.13|TWO_SIDED|95.0|0.14|1.36|||Fisher Exact|||||1.36|0.14|0.13
70994488|NCT01840228|141497684|SUPERIORITY||Risk Ratio (RR)|1.5||||0.71|TWO_SIDED|95.0|0.51|4.43|||Fisher Exact|||||4.43|0.51|0.71
70994489|NCT01840228|141497685|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
70994490|NCT01148563|141497690|SUPERIORITY||Risk Ratio, log|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.094|TWO_SIDED|95.0|-0.65|0.05|||bootstrapping||The hypothesis test was based on ln(relative risk), with the tele-monitoring group value as the relative risk numerator and the control group value as the denominator. The standard error was generated by bootstrapping the sample.|||0.05|-0.65|0.094
70994491|NCT01148563|141497691|SUPERIORITY||Risk Ratio, log|0.7|STANDARD_ERROR_OF_MEAN|0.22||0.105|TWO_SIDED|95.0|0.45|1.08|||bootstrapping|The standard error was generated by bootstrapping the sample.|The hypothesis test was based on ln(relative risk) with the tele-monitoring group value as the numerator and the control group as the denominator.|||1.08|0.45|0.105
71040182|NCT04556734|141588544|OTHER||Response rate difference|5.6||||0.3576|TWO_SIDED|95.0|-5.39|16.59||P-values are based on the comparison of Etrasimod versus placebo.|Cochran-Mantel-Haenszel||Clopper-Pearson method|\>= 75% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 2 mg and DB Treatment period: Placebo||16.59|-5.39|0.3576
71040183|NCT04556734|141588544|OTHER||Response rate difference|8.3||||0.2904|TWO_SIDED|95.0|-3.43|20.12||P-values were based on the comparison of etrasimod versus placebo.|Cochran-Mantel-Haenszel||Clopper-Pearson method|\>= 75% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 3 mg and DB Treatment period: Placebo.||20.12|-3.43|0.2904
71040184|NCT00377572|141588564|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Maximum Symptom Day Comparison||||<0.001
71040185|NCT00377572|141588565|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||||||0.04
71040186|NCT00377572|141588566|SUPERIORITY_OR_OTHER|||||||0.1111||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept (to account for within-subject correlation) and visit and group as fixed effects.||||||0.1111
71040187|NCT00377572|141588567|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Childhood Asthma Control Test comparison||||0.007
71040188|NCT00377572|141588568|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Asthma Control Test comparison||||0.54
71040189|NCT00377572|141588569|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||FEV1 % of predicted value comparison||||0.30
71040190|NCT00377572|141588570|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||FEV1:FVC ×100 comparison||||0.81
71040191|NCT00377572|141588571|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||||||<0.0001
71040192|NCT00377572|141588572|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Percent Adherence Comparison||||0.12
71040193|NCT00377572|141588573|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Step level 1- 2 (mild asthma) Percent Comparison||||0.001
71040194|NCT00377572|141588574|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Step level 4 - 6 (severe asthma)percent comparison||||<0.001
71040195|NCT00377572|141588575|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Inhaled glucocorticoids prescribed - mcg per day comparison||||<0.001
71040196|NCT00377572|141588576|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Comparison percent prescribed long-acting beta 2 agonists||||0.003
71040197|NCT00377572|141588577|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Regression, Logistic|Hospitalizations were summed over the course of the double-blind \& analyzed with logistic regression (LR) of 'any' vs. 'none'. The LR was unadjusted.||||||0.02
71040198|NCT00377572|141588578|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|Exacerbations were summed over the course of the double-blind and analyzed with an LR of 'any' versus 'none'. LR adjusted for study site and dosing.||||||<0.001
71040199|NCT00377572|141588579|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.84
71040200|NCT00377572|141588580|SUPERIORITY_OR_OTHER|||||||0.58||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.58
71040201|NCT01705717|141588585|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||Chi-squared|||||||0.034
71040202|NCT01705717|141588586|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Chi-squared|||||||0.007
71040203|NCT00769314|141588588|SUPERIORITY_OR_OTHER||Treatment difference|0.0685||||0.0419|TWO_SIDED|95.0|0.0025|0.1339||p-value \< 0.05 considered significant|Chi-squared||Treatment difference was the proportion of patients with aborted lesions in the acyclovir Lauriad group minus the proportion of patients with aborted lesions in the placebo group.|||0.1339|0.0025|0.0419
71040204|NCT00769314|141588589|SUPERIORITY_OR_OTHER|||||||0.0683||||||p-value \< 0.05 considered significant|Log Rank|||||||0.0683
71040205|NCT00769314|141588590|SUPERIORITY_OR_OTHER|||||||0.0033||||||p-value \< 0.05 considered significant|Log Rank|||||||0.0033
70923397|NCT03052608|141338193|SUPERIORITY||Mean Difference (Net)|-0.53||||0.6698|TWO_SIDED|95.0|-2.96|1.9|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Pain in Chest. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||1.90|-2.96|0.6698
70923398|NCT03052608|141338193|SUPERIORITY||Mean Difference (Net)|0.45||||0.8035|TWO_SIDED|95.0|-3.13|4.04|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Pain in Arm or Shoulder. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||4.04|-3.13|0.8035
70923399|NCT03052608|141338193|SUPERIORITY||Mean Difference (Net)|3.36||||0.1143|TWO_SIDED|95.0|-0.82|7.55|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Pain in Other Parts. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||7.55|-0.82|0.1143
70923400|NCT03052608|141338196|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.7293|TWO_SIDED|95.0|0.822|1.444|||one-sided stratified log-rank|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Based on Cox Proportional Hazards model stratified by the presence of brain metastases and ethnic origin at randomization. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Lorlatinib.|||1.444|0.822|0.7293
70923401|NCT04204278|141338209|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
70923402|NCT04204278|141338210|OTHER||||||<|0.0001|||||||t-test, 1 sided|P-Value was calculated||||||<0.0001
70923403|NCT04204278|141338211|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
70923404|NCT05873751|141338306|OTHER||Calibrated VE|2.74|||||TWO_SIDED|95.0|-10.35|15.59|||||VE = 1 - HR\*100. The HRs were estimated by exponentiating the coefficient for the vaccine variable in the model. VE was adjusted for the covariates age, gender, and US census region.|||15.59|-10.35|
70923405|NCT05873751|141338307|OTHER||Calibrated VE|-2.2|||||TWO_SIDED|95.0|-23.5|13.85|||||VE = 1 - HR\*100. The HRs were estimated by exponentiating the coefficient for the vaccine variable in the model. VE was adjusted for the covariates age, gender, and US census region.|||13.85|-23.50|
70923406|NCT05873751|141338308|OTHER||Calibrated VE|2.74|||||TWO_SIDED|95.0|-10.35|15.59|||||VE = 1 - HR\*100. The HRs were estimated by exponentiating the coefficient for the vaccine variable in the model. VE was adjusted for the covariates age, gender, and US census region.|||15.59|-10.35|
70923407|NCT05873751|141338309|OTHER||Calibrated VE|-2.2|||||TWO_SIDED|95.0|-23.5|13.85|||||VE = 1 - HR\*100. The HRs were estimated by exponentiating the coefficient for the vaccine variable in the model. VE was adjusted for the covariates age, gender, and US census region.|||13.85|-23.50|
71040206|NCT00769314|141588591|SUPERIORITY_OR_OTHER|||||||0.0098||||||p-value \< 0.05 considered significant|Log Rank|||||||0.0098
71040207|NCT00769314|141588592|SUPERIORITY_OR_OTHER|||||||0.8005||||||p-value \< 0.05 considered significant|Log Rank|||||||0.8005
71040208|NCT00769314|141588593|SUPERIORITY_OR_OTHER|||||||0.015||||||p-value \< 0.05 considered significant|Log Rank|||||||0.015
71040209|NCT00769314|141588594|SUPERIORITY_OR_OTHER|||||||0.0412||||||p-value \< 0.05 considered significant|Log Rank|||||||0.0412
71040210|NCT00769314|141588595|SUPERIORITY_OR_OTHER|||||||0.0271||||||p-value \< 0.05 considered significant|Chi-squared|||||||0.0271
71040211|NCT00769314|141588596|SUPERIORITY_OR_OTHER|||||||0.5695||||||p-value \< 0.05 considered significant|Wilcoxon (Mann-Whitney)|||Analysis conducted between treatment groups at Day 1 timepoint.||||0.5695
71040212|NCT00769314|141588596|SUPERIORITY_OR_OTHER|||||||0.1824||||||p-value \< 0.05 considered significant|Wilcoxon (Mann-Whitney)|||Analysis conducted between treatment groups at Day 3 timepoint||||0.1824
70923408|NCT02140645|141338336|SUPERIORITY_OR_OTHER||C-statistics|0.624|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
70923409|NCT02140645|141338337|SUPERIORITY_OR_OTHER||C-statistcs|0.597|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
70923410|NCT02140645|141338338|SUPERIORITY_OR_OTHER||R-squared|0.0858|||||||||||||The R-squared can be between 0 and 1 and a value of 0 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
70923411|NCT02140645|141338339|SUPERIORITY_OR_OTHER||C-statistics|0.623|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
70923412|NCT02140645|141338340|SUPERIORITY_OR_OTHER||R-squared|0.1753|||||||||||||The R-squared can be between 0 and 1 and a value of 0 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
70923413|NCT02140645|141338341|SUPERIORITY_OR_OTHER||C-statistics|0.699|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
71040213|NCT00769314|141588596|SUPERIORITY_OR_OTHER|||||||0.0078||||||p-value \< 0.05 considered significant|Wilcoxon (Mann-Whitney)|||Analysis conducted between treatment groups at the Day 5 timepoint||||0.0078
71040214|NCT00769314|141588596|SUPERIORITY_OR_OTHER|||||||0.3303||||||p-value \< 0.05 considered significant|Wilcoxon (Mann-Whitney)|||Analysis conducted between treatment groups at the Day 7 timepoint||||0.3303
70994492|NCT01879319|141497692|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-2.4|||||TWO_SIDED|95.0|-11.2|6.1||||||||6.1|-11.2|
70994493|NCT01879319|141497693|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|3.4|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-2.9|9.7||||||||9.7|-2.9|
70994494|NCT00441103|141497726|SUPERIORITY_OR_OTHER||||||<|0.001||||||Non-parametric analysis of variance (ANOVA) with effects for treatment and the absence/presence of Gd-enhancing lesions at baseline as factors|ANOVA|||||||<0.001
70994495|NCT00441103|141497727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.67|STANDARD_DEVIATION|2.33|<|0.001|||||||Wilcoxon signed-rank test|||Mean difference was calculated by subtracting 'Day 1 up to Week 16' from 'Week 17 up to Week 40' and analyzed using Wilcoxon signed-rank test.||||<0.001
70994496|NCT00239837|141497739|SUPERIORITY_OR_OTHER_LEGACY||Wald χ2|7.14||||0.008|TWO_SIDED||||||Regression, Logistic|Data analyzed using repeated logistic regression model (generalized estimating equations). Domain X EV Level X Group interaction tested.|We began the analyses with a full-factorial model regressing choice on domain (gain=1, loss=0), the EV of the risky choice relative to the safe option (EV; range = -.38 to +.38), and dummy-coded treatment groups (Control= -1, Intervention =1).|||||.008
70994497|NCT00302718|141497794|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
70994498|NCT00302718|141497796|OTHER|||||||0.2114|||||||Chi-squared|||||||0.2114
70994499|NCT00302718|141497798|OTHER|||||||0.6954|||||||Chi-squared|||||||0.6954
70994500|NCT00302718|141497800|OTHER|||||||0.9895|||||||Chi-squared|||||||0.9895
71040215|NCT00769314|141588596|SUPERIORITY_OR_OTHER|||||||0.6045||||||p-value \< 0.05 considered significant|Wilcoxon (Mann-Whitney)|||Analysis conducted between treatment groups at the Day 14 timepoint||||0.6045
71040216|NCT00769314|141588597|SUPERIORITY_OR_OTHER|||||||0.0022||||||p-value \< 0.05 considered significant|Chi-squared|||||||0.0022
71099396|NCT00553475|141707601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.94||||0.0014||95.0|-1.51|-0.36|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.36|-1.51|0.0014
70994501|NCT00738374|141497813|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Chi-squared|||Analysis compared responders and non-responders.||||0.0008
70994502|NCT00738374|141497814|SUPERIORITY_OR_OTHER|||||||0.0795|TWO_SIDED||||||Chi-squared|||||||0.0795
70994503|NCT00738374|141497830|SUPERIORITY_OR_OTHER|||||||0.2712|TWO_SIDED||||||Log Rank|||||||0.2712
70994504|NCT01927419|141497869|SUPERIORITY||Mean Difference (Final Values)|49.5|||||TWO_SIDED|95.0|31.4|61.8|||Fisher Exact||Difference of ORR||Exact 95% CI for difference in ORR uses Newcombe's method|61.8|31.4|
70994505|NCT01927419|141497869|SUPERIORITY||Odds Ratio (OR)|12.52|||||TWO_SIDED|95.0|3.79|52.55|||Fisher Exact|||||52.55|3.79|
70994506|NCT01927419|141497870|SUPERIORITY||Hazard Ratio (HR)|0.36|||||TWO_SIDED|95.0|0.21|0.59|||Unstratified Cox proportional hazard||Nivolumab + Ipilimumab over Ipilimumab|||0.59|0.21|
70994507|NCT01927419|141497871|SUPERIORITY||Mean Difference (Final Values)|44.5|||||TWO_SIDED|95.0|8.2|64.8|||Fisher Exact||Difference of ORR||Exact 95% CI for difference in ORR uses Newcombe's method|64.8|8.2|
70994508|NCT01927419|141497871|SUPERIORITY||Odds Ratio (OR)|10.8|||||TWO_SIDED|95.0|1.07|511.89|||Fisher Exact|||||511.89|1.07|
70994509|NCT01927419|141497872|SUPERIORITY||Hazard Ratio (HR)|0.36|||||TWO_SIDED|95.0|0.14|0.97|||Unstratified Cox proportional hazard||Nivolumab + Ipilimumab over Ipilimumab|||0.97|0.14|
70994510|NCT01244191|141497894|SUPERIORITY||Hazard Ratio (HR)|0.981||||0.8086|TWO_SIDED|95.0|0.841|1.149|||Log Rank||Hazard ratio and the 95% confidence interval from stratified Cox-regression model (adjusting for number of prior therapies, gender, and smoking history).|||1.149|0.841|0.8086
70994511|NCT04390568|141497905|OTHER|The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and the area under the concentration-time curve of Spesolimap in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of the intravenous dose groups.|Slope|1.123|STANDARD_ERROR_OF_MEAN|0.085|||TWO_SIDED|90.0|0.979|1.268|||||Based on the estimate for slope parameter (β), a 2-sided 90% confidence interval (CI) for the slope was computed. Standard error of the mean is actually standard error of slope.|No statistical hypotheses tests were planned for this trial.||1.268|0.979|
70994512|NCT04390568|141497906|OTHER|The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and the maximum measured concentration of the Spesolimap in plasma (Cmax) of the intravenous dose groups.|Slope|1.072|STANDARD_ERROR_OF_MEAN|0.065|||TWO_SIDED|90.0|0.961|1.183|||||Based on the estimate for slope parameter (β), a 2-sided 90% confidence interval (CI) for the slope was computed. Standard error of the mean is actually standard error of slope.|No statistical hypotheses tests were planned for this trial.||1.183|0.961|
70994513|NCT01511107|141497909|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 10% was used. Non-inferiority can be established by placing a confidence interval on the difference in the proportion of TFs in subjects randomized to the 10 day regimen and the proportion of TFs in subjects randomized to the 5 day regimen, and determining whether the lower 95% confidence bound is greater than -10%.|Difference between proportions|-0.172|STANDARD_DEVIATION|0.039|||TWO_SIDED|95.0|-0.253|-0.091||||||The null hypothesis that amoxicillin-clavulanate 5 days, placebo 5 days (reduced duration) is inferior to amoxicillin-clavulanate 10 days (standard duration) is tested against the alternative that reduced duration treatment is noninferior. Assuming failure rates of 15% and 25% in the standard and reduced duration groups, respectively, a 2-sided significance level of .05 and 10% attrition, it was calculated that 300 participants per group, would provide power of 95% for finding inferiority.||-.091|-.253|
71099397|NCT00553475|141707602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.73||||0.0003||95.0|-1.12|-0.33|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.33|-1.12|0.0003
70994514|NCT01511107|141497910|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 10% was used. Non-inferiority can be established by placing a confidence interval on the difference in the proportion of TFs in subjects randomized to the 10 day regimen and the proportion of TFs in subjects randomized to the 5 day regimen, and determining whether the lower 95% confidence bound is greater than -10%.|Difference between proportions|-0.096|STANDARD_DEVIATION|0.053|||TWO_SIDED|95.0|-0.209|0.016||||||||.016|-.209|
70994515|NCT01511107|141497911|SUPERIORITY_OR_OTHER|||||||0.45|||||||Regression, Logistic|||Null hypothesis: There is no difference between the two groups in the proportion of children whose NP isolates at enrollment are negative for AOM pathogens for whom the NP culture at day 12-14 yields a nonsusceptible pathogen.||||0.45
70994516|NCT01511107|141497912|SUPERIORITY_OR_OTHER|||||||0.95|||||||Generalized estimating equations|||Null hypothesis: For AOM recurrences with a NP culture at onset that is negative for AOM pathogens, there is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible pathogen.||||0.95
70994517|NCT01511107|141497913|SUPERIORITY_OR_OTHER|||||||0.59|||||||Regression, Logistic|||Null hypothesis: There is no difference between the two groups in the proportion of children whose NP isolates at enrollment are positive only for one or more susceptible pathogens for whom the NP culture at day 12-14 yields a nonsusceptible pathogen.||||0.59
70994518|NCT01511107|141497914|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Generalized estimating equations|||Null hypothesis: For AOM recurrences with a NP culture at onset that is positive only for one or more susceptible pathogens, there is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible pathogen.||||>0.99
70994519|NCT01511107|141497915|SUPERIORITY_OR_OTHER|||||||0.47|||||||Regression, Logistic|||Null hypothesis: There is no difference between the two groups in the proportion of children whose NP isolates at enrollment are positive for one or more nonsusceptible pathogens for whom the NP culture at day 12-14 yields a nonsusceptible pathogen.||||0.47
70994520|NCT01511107|141497916|SUPERIORITY_OR_OTHER|||||||0.05|||||||Generalized estimating equations|||Null hypothesis: For AOM recurrences with a NP culture at onset that is positive for one or more nonsusceptible pathogens, there is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible pathogen.||||0.05
70994521|NCT01511107|141497917|SUPERIORITY_OR_OTHER|||||||0.58|||||||Regression, Logistic|The p-value is adjusted for the culture result at enrollment.||Null hypothesis: There is no difference in the proportion of subjects whose NP isolates at enrollment are pathogen-negative or positive only for at least one susceptible pathogen who become colonized with penicillin non-susceptible pathogens at any time over the course of follow-up||||0.58
70994522|NCT01511107|141497918|SUPERIORITY_OR_OTHER|||||||0.74|||||||Generalized estimating equations|||Null hypothesis: There is no difference in the proportion of 6 week follow-up, non-illness visits at which a penicillin-nonsusceptible pathogen is recovered.||||0.74
70994523|NCT01511107|141497919|SUPERIORITY_OR_OTHER|||||||0.72|||||||Regression, Logistic|The p-value is adjusted for S pn susceptibility at the index episode.||Null hypothesis: There is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible S pn isolate.||||0.72
70994524|NCT01511107|141497920|SUPERIORITY_OR_OTHER|||||||0.05|||||||Generalized estimating equations|The p-value is adjusted for S pn susceptibility at onset of the AOM recurrence.||||||0.05
70994525|NCT01511107|141497921|SUPERIORITY_OR_OTHER|||||||0.47|||||||Regression, Logistic|The p-value is adjusted for H flu susceptibility at onset of the index episode.||Null hypothesis: There is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible H flu isolate.||||0.47
70994526|NCT01511107|141497922|SUPERIORITY_OR_OTHER|||||||0.69|||||||Generalized estimating equations|The p-value is adjusted for H flu susceptibility at onset of the AOM recurrence.||||||0.69
70994527|NCT01511107|141497923|SUPERIORITY_OR_OTHER|||||||0.16|||||||Regression, Logistic|The p-value is adjusted for site \& the stratification variables, namely age group \& exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the proportion of children followed greater than 60 days having at least one AOM relapse or recurrence within 60 days of enrollment.||||0.16
70994528|NCT01511107|141497924|SUPERIORITY_OR_OTHER|||||||0.32|||||||Regression, Logistic|The p-value is adjusted for site \& the stratification variables, namely age group \& exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the proportion of children completing the study having at least one AOM relapse or recurrence within the entire respiratory season.||||0.32
70994529|NCT01511107|141497925|SUPERIORITY_OR_OTHER|||||||0.23|||||||Regression, Poisson|The p-value is adjusted for site \& the stratification variables, namely age group \& exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the rate of recurrences/relapses within 60 days of enrollment.||||0.23
70994530|NCT01511107|141497926|SUPERIORITY_OR_OTHER|||||||0.22|||||||Regression, Poisson|The p-value is adjusted for site \& the stratification variables, namely age group \& exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the rate of recurrences/relapses within the entire respiratory season.||||0.22
70994531|NCT01511107|141497927|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Linear|The p-value is adjusted for site \& the stratification variables and for length of follow-up.||Null hypothesis: There is no difference between the two groups in the mean number of days a systemic antibiotic was received during the respiratory season.||||<.001
70994532|NCT01511107|141497928|SUPERIORITY_OR_OTHER|||||||0.07|||||||Generalized estimating equations|The p-value is adjusted for site \& the stratification variables, episode, day of the diary and AOM-SOS score at the episode.||Null hypothesis: There is no difference between the two groups regarding the symptom burden as measured by the respective mean scores over time.||||0.07
71099398|NCT00553475|141707602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.86||||0.0036||95.0|-1.44|-0.28|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.28|-1.44|0.0036
71099399|NCT00553475|141707603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.0005||95.0|-1.1|-0.31|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.31|-1.10|0.0005
71099400|NCT00553475|141707603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87||||0.0034||95.0|-1.46|-0.29|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.29|-1.46|0.0034
71099401|NCT00553475|141707604|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.62||||0.0023||95.0|-1.02|-0.22|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.22|-1.02|0.0023
71099402|NCT00553475|141707604|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.77||||0.0105||95.0|-1.36|-0.18|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.18|-1.36|0.0105
71099403|NCT00553475|141707605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.65||||0.0016||95.0|-1.05|-0.25|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.25|-1.05|0.0016
71099404|NCT00553475|141707605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.77||||0.0111||95.0|-1.37|-0.18|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.18|-1.37|0.0111
71099405|NCT00553475|141707606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.07||||0.6118||95.0|-5.23|3.08|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.08|-5.23|0.6118
71099406|NCT00553475|141707606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.59||||0.0109||95.0|1.76|13.42|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||13.42|1.76|0.0109
70994533|NCT01511107|141497929|SUPERIORITY_OR_OTHER|||||||0.7|||||||Regression, Logistic|The p-value is adjusted for site \& the stratification variables, namely age group \& exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the proportion of children for whom PDD was reported.||||0.70
71099407|NCT00553475|141707607|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.49||||0.4602||95.0|-2.47|5.45|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.45|-2.47|0.4602
71099408|NCT00553475|141707607|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.97||||0.1625||95.0|-1.61|9.54|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||9.54|-1.61|0.1625
71099409|NCT00553475|141707608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|||<|0.0001||95.0|-1.25|-0.46|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.46|-1.25|<0.0001
71099410|NCT00553475|141707608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63||||0.0273||95.0|-1.19|-0.07|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.07|-1.19|0.0273
71099411|NCT00553475|141707609|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.79||||0.0013||95.0|-2.87|-0.71|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.71|-2.87|0.0013
71099412|NCT00553475|141707609|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.13||||0.0062||95.0|-3.65|-0.61|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.61|-3.65|0.0062
71099413|NCT00553475|141707610|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.0068||95.0|-1.03|-0.17|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.17|-1.03|0.0068
71099414|NCT00553475|141707610|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56||||0.0707||95.0|-1.17|0.05|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.05|-1.17|0.0707
70923414|NCT02140645|141338342|SUPERIORITY_OR_OTHER||C-statistics|0.683|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
70994534|NCT01511107|141497930|SUPERIORITY_OR_OTHER|||||||0.86|||||||Regression, Logistic|The p-value is adjusted for site \& the stratification variables, namely age group \& exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the proportion of children for whom diaper dermatitis was reported.||||0.86
70994535|NCT01146951|141497931|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-26.65||||0.003|TWO_SIDED|90.0|-40.3|-11.8|||Wilcoxon (Mann-Whitney)|||||-11.80|-40.30|0.003
70994536|NCT01146951|141497932|SUPERIORITY_OR_OTHER|||||||0.074|||||||Fisher's exact test|||||||0.074
71099415|NCT00553475|141707611|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.35||||0.0013||95.0|-3.76|-0.93|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.93|-3.76|0.0013
71099416|NCT00553475|141707611|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.67||||0.0087||95.0|-4.67|-0.68|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.68|-4.67|0.0087
71099417|NCT00553475|141707612|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.27||||0.0056||95.0|-12.4|-2.14|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-2.14|-12.40|0.0056
71099418|NCT00553475|141707612|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.49||||0.0427||95.0|-14.74|-0.25|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.25|-14.74|0.0427
71099419|NCT00553475|141707613|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.21||||0.0365||95.0|-0.4|-0.01|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.01|-0.40|0.0365
71099420|NCT00553475|141707613|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37||||0.0073||95.0|-0.65|-0.1|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.10|-0.65|0.0073
71099421|NCT00553475|141707614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.37||||0.0019||95.0|-10.38|-2.36|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-2.36|-10.38|0.0019
70923415|NCT02140645|141338343|SUPERIORITY_OR_OTHER||C-statistics|0.757|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
70994537|NCT01146951|141497933|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-33.3|||<|0.001|TWO_SIDED|90.0|-47.1|-17.0|||Wilcoxon (Mann-Whitney)|||||-17.00|-47.10|<0.001
70994538|NCT01146951|141497934|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-57.15||||0.025|TWO_SIDED|90.0|-104.5|-17.3|||Wilcoxon (Mann-Whitney)|||Analysis for Partial Seizure Frequency||-17.30|-104.50|0.025
70994539|NCT01146951|141497934|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-28.65||||0.128|TWO_SIDED|90.0|-72.0|0.9|||Wilcoxon (Mann-Whitney)|||Analysis of atypical absence seizure frequency||0.90|-72.00|0.128
70994540|NCT01146951|141497934|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-54.35||||0.021|TWO_SIDED|90.0|-126.6|-15.4|||Wilcoxon (Mann-Whitney)|||Analysis for myoclonic seizure frequency||-15.40|-126.60|0.021
70994541|NCT01146951|141497934|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-23.2||||0.031|TWO_SIDED|90.0|-40.7|-5.6|||Wilcoxon (Mann-Whitney)|||Analysis of tonic seizure frequency||-5.60|-40.70|0.031
70994542|NCT01146951|141497934|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-71.4||||0.107|TWO_SIDED|90.0|-464.7|30.5|||Wilcoxon (Mann-Whitney)|||Analysis for Tonic-clonic seizure frequency||30.50|-464.70|0.107
71099422|NCT00553475|141707614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.78||||0.1907||95.0|-9.45|1.89|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||1.89|-9.45|0.1907
71099423|NCT00553475|141707615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03||||0.9905||95.0|-5.37|5.43|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.43|-5.37|0.9905
71099424|NCT00553475|141707615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.44||||0.2532||95.0|-3.19|12.08|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.08|-3.19|0.2532
71099425|NCT00553475|141707616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.39||||0.4538||95.0|-5.05|2.26|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||2.26|-5.05|0.4538
71099426|NCT00553475|141707616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.84||||0.2782||95.0|-7.97|2.3|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||2.30|-7.97|0.2782
71099427|NCT00553475|141707617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32||||0.0177||95.0|0.06|0.59|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.59|0.06|0.0177
71099428|NCT00553475|141707617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17||||0.3661||95.0|-0.2|0.55|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.55|-0.20|0.3661
71099429|NCT00553475|141707618|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.62||||0.0511||95.0|-0.03|11.26|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||11.26|-0.03|0.0511
71099430|NCT00553475|141707618|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.65||||0.0173||95.0|1.72|17.59|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||17.59|1.72|0.0173
71099431|NCT00553475|141707619|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.79||||0.1123||95.0|-0.89|8.47|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||8.47|-0.89|0.1123
71099432|NCT00553475|141707619|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.79||||0.0206||95.0|1.2|14.38|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||14.38|1.20|0.0206
71099433|NCT00553475|141707620|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.54||||0.0269||95.0|-6.67|-0.41|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.41|-6.67|0.0269
71099434|NCT00553475|141707620|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.82||||0.4183||95.0|-6.24|2.6|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||2.60|-6.24|0.4183
71099435|NCT00553475|141707621|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0148||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel chi-squared with a modified ridit transformation, stratified by stratum based on the CLcr||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0148
71099436|NCT00553475|141707621|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0063||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel chi-squared with a modified ridit transformation, stratified by stratum based on the CLcr||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0063
71099437|NCT00553475|141707622|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0818||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel chi-squared with a modified ridit transformation, stratified by stratum based on the CLcr||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0818
71099438|NCT00553475|141707622|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0075||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel chi-squared with a modified ridit transformation, stratified by stratum based on the CLcr||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0075
71099439|NCT00553475|141707623|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66||||0.0013||95.0|-1.07|-0.26|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.26|-1.07|0.0013
70994543|NCT01146951|141497934|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-52.1||||0.221|TWO_SIDED|90.0|-89.1|10.8|||Wilcoxon (Mann-Whitney)|||Analysis of Atonic seizure frequency||10.80|-89.10|0.221
70994544|NCT01146951|141497935|SUPERIORITY_OR_OTHER|||||||0.041|||||||Wilcoxon (Mann-Whitney)|||Analysis of Week 12 of the Treatment Period||||0.041
70994545|NCT01146951|141497935|SUPERIORITY_OR_OTHER|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||Analysis of final assessment (LOCF)||||0.007
70994546|NCT01299610|141497936|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.38|STANDARD_ERROR_OF_MEAN|0.538||0.48|TWO_SIDED|95.0|-1.46|0.7|||Mixed model for repeated measures|||||0.70|-1.46|0.480
70994547|NCT01299610|141497936|SUPERIORITY_OR_OTHER||mixed model for repeated measures|-0.89|STANDARD_ERROR_OF_MEAN|0.557||0.118|TWO_SIDED|95.0|-2.0|0.23|||Mixed model for repeated measures|||||0.23|-2.00|0.118
70994548|NCT01299610|141497936|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-1.51|STANDARD_ERROR_OF_MEAN|0.572||0.011|TWO_SIDED|95.0|-2.65|-0.36|||Mixed model for repeated measures|||||-0.36|-2.65|0.011
71099440|NCT00553475|141707623|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74||||0.0152||95.0|-1.34|-0.14|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.14|-1.34|0.0152
70994549|NCT01299610|141497937|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.09|STANDARD_ERROR_OF_MEAN|0.16||0.581|TWO_SIDED|95.0|-0.24|0.42|||Mixed model repeated measures|||GW870086, 0.2% cream Vs Placebo: Day 2||0.42|-0.24|0.581
70994550|NCT01299610|141497937|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.08|STANDARD_ERROR_OF_MEAN|0.169||0.655|TWO_SIDED|95.0|-0.42|0.27|||Mixed model repeated measures|||GW870086, 2.0% cream Vs Placebo: Day 2||0.27|-0.42|0.655
70994551|NCT01299610|141497937|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.17|STANDARD_ERROR_OF_MEAN|0.174||0.336||95.0|-0.52|0.18|||Mixed model repeated measures|||FP, 0.05% cream Vs Placebo: Day 2||0.18|-0.52|0.336
70994552|NCT01299610|141497937|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.03|STANDARD_ERROR_OF_MEAN|0.302||0.923|TWO_SIDED|95.0|-0.58|0.63|||Mixed model repeated measures|||GW870086 0.2% cream Vs Placebo: Day 3||0.63|-0.58|0.923
71099441|NCT02722330|141707649|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||||||<0.0001
71099442|NCT02722330|141707650|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Ease of communication||||<0.0001
71099443|NCT02722330|141707650|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed rank Test|||Reverberation||||<0.0001
71099444|NCT02722330|141707650|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed rank Test|||Background noise||||<0.0001
70994553|NCT01299610|141497937|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.14|STANDARD_ERROR_OF_MEAN|0.314||0.657|TWO_SIDED|95.0|-0.49|0.77|||Mixed model repeated measures|||GW870086, 2.0% cream, Placebo: Day 3||0.77|-0.49|0.657
70994554|NCT01299610|141497937|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.28|STANDARD_ERROR_OF_MEAN|0.323||0.386|TWO_SIDED|95.0|-0.93|0.36|||Mixed model repeated measures|||Placebo, FP, 0.05% cream: Day 3||0.36|-0.93|0.386
70994555|NCT01299610|141497937|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.24|STANDARD_ERROR_OF_MEAN|0.456||0.601|TWO_SIDED|95.0|-1.15|0.67|||Mixed model repeated measures|||GW870086, 0.2% cream, Placebo: Day 7||0.67|-1.15|0.601
70994556|NCT01299610|141497937|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.6|STANDARD_ERROR_OF_MEAN|0.472||0.212|TWO_SIDED|95.0|-1.54|0.35|||Mixed model repeated measures|||GW870086, 2.0% cream, Placebo: Day 7||0.35|-1.54|0.212
70994557|NCT01299610|141497937|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-1.29|STANDARD_ERROR_OF_MEAN|0.485||0.01|TWO_SIDED|95.0|-2.26|-0.32|||Mixed model repeated measures|||Placebo, FP, 0.05% cream: Day 7||-0.32|-2.26|0.010
70994558|NCT01299610|141497937|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.24|STANDARD_ERROR_OF_MEAN|0.462||0.602|TWO_SIDED|95.0|-1.17|0.68|||Mixed model repeated measures|||GW870086, 0.2% cream, Placebo: Day 14||0.68|-1.17|0.602
70994559|NCT01299610|141497937|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.65|STANDARD_ERROR_OF_MEAN|0.479||0.18|TWO_SIDED|95.0|-1.61|0.31|||Mixed model repeated measures|||GW870086, 2.0% cream, Placebo: Day 14||0.31|-1.61|0.180
70994560|NCT01299610|141497937|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-1.39|STANDARD_ERROR_OF_MEAN|0.492||0.006|TWO_SIDED|95.0|-2.37|-0.4|||Mixed model repeated measures|||Placebo, FP, 0.05% cream: Day 14||-0.40|-2.37|0.006
70994561|NCT00804843|141497947|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.27||||0.811|TWO_SIDED|90.0|-0.24|0.78|||ANOVA|||||0.78|-0.24|0.811
71099445|NCT02722330|141707650|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Wilcoxon Signed rank Test|||Aversiveness||||0.0004
71099446|NCT02722330|141707650|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed rank Test|||Global score||||<0.0001
71099447|NCT02722330|141707651|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech scale||||<0.0001
71099448|NCT02722330|141707651|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Spatial scale||||<0.0001
71099449|NCT02722330|141707651|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Qualities scale||||<0.0001
71099450|NCT02722330|141707652|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||||||<0.0001
71099451|NCT02722330|141707653|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||250 Hz||||<0.0001
71099452|NCT02722330|141707653|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||500 Hz||||<0.0001
71099453|NCT02722330|141707653|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||750 Hz||||<0.0001
71099454|NCT02722330|141707653|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||1000 Hz||||<0.0001
71099455|NCT02722330|141707653|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||1500 Hz||||<0.0001
71099456|NCT02722330|141707653|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||2000 Hz||||<0.0001
71099457|NCT02722330|141707653|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||3000 Hz||||<0.0001
70994562|NCT00804843|141497948|SUPERIORITY_OR_OTHER||Least Square Mean Difference|3.64||||0.898|TWO_SIDED|90.0|-1.09|8.36|||ANOVA|||||8.36|-1.09|0.898
70994563|NCT04172701|141497963|OTHER||||||<|0.0001|||||||Individual log-linked Poisson model|||||||<0.0001
70994564|NCT04172701|141497964|OTHER||||||<|0.001|||||||Individual t-test or Wilcoxon test|||||||<0.001
70994565|NCT04172701|141497965|OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
70994566|NCT04172701|141497966|OTHER||Hazard Ratio (HR)|1.475|||<|0.0001|TWO_SIDED|95.0|1.308|1.663|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model.The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.663|1.308|<0.0001
70994567|NCT04172701|141497967|OTHER|||||||0.0003|||||||Individual log-linked Poisson model|||||||0.0003
70994568|NCT04172701|141497968|OTHER|||||||0.001|||||||Individual t-test or Wilcoxon test|||||||0.001
70994569|NCT04172701|141497969|OTHER||Hazard Ratio (HR)|1.145||||0.0006|TWO_SIDED|95.0|1.059|1.237|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model. The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.237|1.059|0.0006
70994570|NCT04172701|141497970|OTHER|||||||0.00074|||||||Log Rank|||||||0.00074
70994571|NCT04172701|141497971|OTHER||||||<|0.0001|||||||Individual log-linked Poisson model|||||||<0.0001
70994572|NCT04172701|141497972|OTHER||Hazard Ratio (HR)|1.601|||<|0.0001|TWO_SIDED|95.0|1.404|1.826|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model. The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.826|1.404|<0.0001
70994573|NCT04172701|141497973|OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
70994574|NCT04172701|141497974|OTHER|||||||0.2875|||||||Wilcoxon (Mann-Whitney)|||||||0.2875
70994575|NCT04172701|141497975|OTHER|||||||0.4602|||||||Individual t-test or Wilcoxon test|||||||0.4602
70994576|NCT04172701|141497976|OTHER|||||||0.0062|||||||Wilcoxon (Mann-Whitney)|||||||0.0062
70994577|NCT04172701|141497977|OTHER|||||||0.0002|||||||Individual t-test or Wilcoxon test|||||||0.0002
70994578|NCT04172701|141497978|OTHER|||||||0.4907|||||||Individual t-test or Wilcoxon test|||||||0.4907
70994579|NCT04172701|141497979|OTHER||||||<|0.001|||||||Individual t-test or Wilcoxon test|||||||<0.001
70994580|NCT04172701|141497980|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70994581|NCT04172701|141497981|OTHER|||||||0.543|||||||Individual t-test or Wilcoxon test|||||||0.543
70994582|NCT04172701|141497982|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.080
70994583|NCT04172701|141497983|OTHER|||||||0.363|||||||Individual t-test or Wilcoxon test|||||||0.363
71099458|NCT02722330|141707653|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||4000 Hz||||<0.0001
71099459|NCT02722330|141707653|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||6000 Hz||||<0.0001
71099460|NCT02722330|141707654|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||250 Hz||||<0.0001
71099461|NCT02722330|141707654|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||500 Hz||||<0.0001
71099462|NCT02722330|141707654|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||750 Hz||||<0.0001
71099463|NCT02722330|141707654|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||1000 Hz||||<0.0001
71099464|NCT02722330|141707654|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||1500 Hz||||<0.0001
71099465|NCT02722330|141707654|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||2000 Hz||||<0.0001
71099466|NCT02722330|141707654|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||3000 Hz||||<0.0001
70994584|NCT04172701|141497984|OTHER||||||<|0.0001|||||||Individual t-test or Wilcoxon test|||||||<0.0001
70994585|NCT04172701|141497985|OTHER|||||||0.0494|||||||Individual t-test or Wilcoxon test|||||||0.0494
70994586|NCT04172701|141497986|OTHER|||||||0.0091|||||||Individual t-test or Wilcoxon test|||||||0.0091
70994587|NCT04172701|141497987|OTHER||||||<|0.0001|||||||Individual t-test or Wilcoxon test|||||||<0.0001
70994588|NCT04172701|141497988|OTHER||||||<|0.0001|||||||Individual t-test or Wilcoxon test|||||||<0.0001
70994589|NCT04172701|141497989|OTHER|||||||0.7298|||||||Individual t-test or Wilcoxon test|||||||0.7298
70994590|NCT04172701|141497990|OTHER|||||||0.0093|||||||Individual t-test or Wilcoxon test|||||||0.0093
70994591|NCT04172701|141497991|OTHER||||||<|0.0001|||||||Individual t-test or Wilcoxon test|||||||<0.0001
70994592|NCT04172701|141497992|OTHER||Cost ratio|1.177|||<|0.0001|TWO_SIDED|95.0|1.104|1.255|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.255|1.104|<0.0001
70994593|NCT04172701|141497993|OTHER||Cost ratio|1.194||||0.0103|TWO_SIDED|95.0|1.043|1.367|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.367|1.043|0.0103
70994594|NCT04172701|141497994|OTHER||Cost ratio|1.104||||0.003|TWO_SIDED|95.0|1.034|1.178|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.178|1.034|0.0030
71099467|NCT02722330|141707654|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||4000 Hz||||<0.0001
71099468|NCT02722330|141707654|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||6000 Hz||||<0.0001
71099469|NCT02722330|141707655|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon Signed Rank test|||||||0.002
71099470|NCT02722330|141707656|SUPERIORITY_OR_OTHER|||||||0.0024|||||||Wilcoxon Signed Rank test|||||||0.0024
71099471|NCT02722330|141707657|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech Presentation Level 50 dB||||<0.0001
71099472|NCT02722330|141707657|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech Presentation Level 65 dB||||<0.0001
71099473|NCT02722330|141707657|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech Presentation Level 80 dB||||<0.0001
71099474|NCT02722330|141707658|SUPERIORITY_OR_OTHER||||||<|0.0001||||||All variable had the same p value (\<0.0001).|Wolcoxon Signed rank test|||Speech Presentation Level 50 dB||||<0.0001
70923416|NCT02140645|141338344|SUPERIORITY_OR_OTHER||C-statistics|0.618|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
70923417|NCT02140645|141338345|SUPERIORITY_OR_OTHER||C-statistics|0.618|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
70923418|NCT02140645|141338346|SUPERIORITY_OR_OTHER||C-statistics|0.733|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
70923419|NCT02140645|141338347|SUPERIORITY_OR_OTHER||C-statistics|0.827|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
70923420|NCT02140645|141338348|SUPERIORITY_OR_OTHER||C-statistics|0.801|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
70923421|NCT02140645|141338349|SUPERIORITY_OR_OTHER||C-statistics|0.836|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
70923422|NCT00593489|141338356|SUPERIORITY||Risk Ratio (RR)|0.99||||0.96|TWO_SIDED|95.0|0.8|1.24|||Poisson Regression|||The IPR was analyzed using Poisson regression with the intervention group as a class effect and the mean HbA1c at baseline as a covariate||1.24|0.8|0.96
70923423|NCT04455035|141338411|OTHER|ttest||||||0.0088|||||||t-test, 2 sided|||||||0.0088
71099475|NCT02722330|141707658|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech Presentation Level 65 dB||||<0.0001
71099476|NCT02722330|141707658|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech Presentation Level 80 dB||||<0.0001
71099477|NCT02722330|141707659|SUPERIORITY_OR_OTHER|||||||0.036|||||||Wilcoxon Signed Rank test|||||||0.036
71099478|NCT02722330|141707660|SUPERIORITY_OR_OTHER|||||||0.065|||||||Wilcoxon Signed Rank test|||||||0.065
70923424|NCT04455035|141338412|OTHER|ttest||||||1e-05|||||||t-test, 2 sided|||||||0.00001
70923425|NCT02728557|141338443|OTHER|MLM models||||||0.016|||||||MLM|MLM||A model with two three-way interactions of time by treatment condition by attachment orientation (Time Å\~ Treatment condition Å\~ Attachment anxiety, Time Å\~ Treatment condition Å\~ Attachment avoidance) along the lower-level effects to predict differences in the slope of change in outcome. The threshold for statistical significance was p\>0.05.||||.016
70923426|NCT03416010|141338449|OTHER||||||<|0.001|||||||two-way ANOVA|||Null Hypothesis: There was no significant difference in Health Beliefs across those 4 time points.||||<0.001
70923427|NCT03416010|141338449|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference between the full intervention group, COPE-P, and the attention-control group, Preg+, in Health Beliefs, as measured by the Healthy Lifestyle Beliefs measure, at T0 baseline, as well as at time points 1, immediately following the intervention, 2, 6 weeks after the infants' birth, and 3, 6 months after the infants' birth||||<0.001
70923428|NCT03416010|141338449|OTHER|||||||0.009|||||||two-way ANOVA|||Null hypothesis: There was no statistically significant interaction between the intervention group and time.||||0.009
70923429|NCT03416010|141338450|OTHER||||||<|0.001||||||Threshold for significance: p \<0.01|two-way ANOVA|||Null hypothesis: there was no significant difference in anxiety across the 4 time points.||||<0.001
70923430|NCT03416010|141338450|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference between the two groups in anxiety at T0 baseline, as well as at timepoint 1(immediately following the intervention), timepoint 2 (6 weeks after the infants' birth), and timepoint 3 (6 months after the infants' birth).||||<0.001
70923431|NCT03416010|141338450|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no statistically significant interaction between the intervention group and time.||||<0.001
70923432|NCT03416010|141338451|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference in health behaviors across those 4 time points.||||<0.001
70923433|NCT03416010|141338451|OTHER||||||<|0.001|||||||two-way ANOVA|||||||<0.001
70923434|NCT03416010|141338451|OTHER||||||<|0.001|||||||two-way ANOVA|||Null Hypothesis: There was no statistically significant interaction between the intervention group and time.||||<0.001
70923435|NCT03416010|141338452|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference in depressive symptoms across those 4 timepoints.||||<0.001
70923436|NCT03416010|141338452|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference between the two groups in depressive symptoms at T0 baseline, as well as at time points 1, immediately following the intervention, 2, 6 weeks after the infants' birth, and 3, 6 months after the infants' birth.||||<0.001
70923437|NCT03416010|141338452|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no statistically significant interaction between the intervention group and time.||||<0.001
70923438|NCT03416010|141338453|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference in stress across those 4 time points.||||<0.001
70994595|NCT04172701|141497995|OTHER||Cost ratio|1.175|||<|0.0001|TWO_SIDED|95.0|1.13|1.221|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.221|1.130|<0.0001
71099479|NCT02722330|141707661|SUPERIORITY_OR_OTHER|||||||0.47|||||||Wilcoxon Signed Rank test|||250 Hz||||0.47
71099480|NCT02722330|141707661|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon Signed Rank test|||500 Hz||||0.16
71099481|NCT02722330|141707661|SUPERIORITY_OR_OTHER|||||||0.59|||||||Wilcoxon Signed Rank test|||750 Hz||||0.59
71099482|NCT02722330|141707661|SUPERIORITY_OR_OTHER|||||||0.034|||||||Wilcoxon Signed Rank test|||1000 Hz||||0.034
70994596|NCT04172701|141497996|OTHER||Cost ratio|1.236|||<|0.0001|TWO_SIDED|95.0|1.134|1.346|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.346|1.134|<0.0001
70994597|NCT04172701|141497997|OTHER||Cost ratio|1.214||||0.0212|TWO_SIDED|95.0|1.029|1.431|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.431|1.029|0.0212
70994598|NCT04172701|141497998|OTHER||Cost ratio|1.026||||0.5024|TWO_SIDED|95.0|0.952|1.105|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.105|0.952|0.5024
70994599|NCT04172701|141497999|OTHER||Cost ratio|1.304|||<|0.0001|TWO_SIDED|95.0|1.243|1.369|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.369|1.243|<0.0001
70994600|NCT04172701|141498000|OTHER|||||||0.7198|||||||Individual log-linked Poisson model|||||||0.7198
70994601|NCT04172701|141498001|OTHER||Hazard Ratio (HR)|1.072||||0.7341|TWO_SIDED|95.0|0.719|1.598|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model. The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.598|0.719|0.7341
70994602|NCT04172701|141498002|OTHER|||||||0.74|||||||Log Rank|||||||0.74
70994603|NCT04172701|141498003|OTHER|||||||0.9985|||||||Individual log-linked Poisson model|||||||0.9985
71099483|NCT02722330|141707661|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon Signed Rank test|||1500 Hz||||0.25
71099484|NCT02722330|141707661|SUPERIORITY_OR_OTHER|||||||0.023|||||||Wilcoxon Signed Rank test|||2000 Hz||||0.023
71099485|NCT02722330|141707661|SUPERIORITY_OR_OTHER|||||||0.028|||||||Wilcoxon Signed Rank test|||3000 Hz||||0.028
71099486|NCT02722330|141707661|SUPERIORITY_OR_OTHER|||||||0.0075|||||||Wilcoxon Signed Rank test|||4000 Hz||||0.0075
70994604|NCT04172701|141498004|OTHER||Hazard Ratio (HR)|0.879||||0.5097|TWO_SIDED|95.0|0.6|1.289|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model. The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.289|0.600|0.5097
70994605|NCT04172701|141498005|OTHER|||||||0.51|||||||Log Rank|||||||0.51
70994606|NCT04172701|141498006|OTHER|||||||0.6069|||||||Individual log-linked Poisson model|||||||0.6069
70994607|NCT04172701|141498007|OTHER||Hazard Ratio (HR)|1.025||||0.896|TWO_SIDED|95.0|0.705|1.49|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model. The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.490|0.705|0.8960
70994608|NCT04172701|141498008|OTHER|||||||0.9|||||||Log Rank|||||||0.9
70994609|NCT04172701|141498009|OTHER|||||||0.1354|||||||Individual log-linked Poisson model|||||||0.1354
71099487|NCT02722330|141707661|SUPERIORITY_OR_OTHER|||||||0.0035|||||||Wilcoxon Signed Rank test|||6000 Hz||||0.0035
71099488|NCT02722330|141707662|SUPERIORITY_OR_OTHER|||||||0.12|||||||Wilcoxon Signed Rank test|||250 Hz||||0.12
71099489|NCT02722330|141707662|SUPERIORITY_OR_OTHER|||||||0.072|||||||Wilcoxon Signed Rank test|||500 Hz||||0.072
71099490|NCT02722330|141707662|SUPERIORITY_OR_OTHER|||||||0.56|||||||Wilcoxon Signed Rank test|||750 Hz||||0.56
71099491|NCT02722330|141707662|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon Signed Rank test|||1000 Hz||||0.16
70994610|NCT04172701|141498010|OTHER||Hazard Ratio (HR)|0.59||||0.1158|TWO_SIDED|95.0|0.305|1.139|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model. The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.139|0.305|0.1158
70994611|NCT04172701|141498011|OTHER|||||||0.11|||||||Log Rank|||||||0.11
70994612|NCT02126670|141498012|SUPERIORITY_OR_OTHER|||||||0.799|TWO_SIDED||||||Chi-squared|||||||0.799
70994613|NCT01975246|141498014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|TWO_SIDED|95.0|-5.3|-2.4|||ANCOVA|Model includes baseline DBP as a linear covariate, and treatment and center as fixed effects.||The last observation carried forward (LOCF) method was applied for missing data, where the value from the measurements at the closest preceding visit replaced the missing value.||-2.4|-5.3|<0.0001
70994614|NCT01975246|141498015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|-7.6|-3.1|||ANCOVA|Model includes baseline SBP as a linear covariate, and treatment and center as fixed effects.||The last observation carried forward (LOCF) method was applied for missing data, where the value from the measurements at the closest preceding visit replaced the missing value.||-3.1|-7.6|<0.0001
71099492|NCT02722330|141707662|SUPERIORITY_OR_OTHER|||||||0.39|||||||Wilcoxon Signed Rank test|||1500 Hz||||0.39
71099493|NCT02722330|141707662|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon Signed Rank test|||2000 Hz||||0.11
71099494|NCT02722330|141707662|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon Signed Rank test|||3000 Hz||||0.38
70994615|NCT01975246|141498016|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||<|0.0051|TWO_SIDED|95.0|1.2|3.4|||Regression, Logistic|Logistic regression model includes treatment and center as fixed effects.||"The Non-completers considered failure (NCF) method was applied for missing data, where missing data due to early discontinuation will be replaced as failure up to the planned final visit to be reached by all patients."||3.4|1.2|<0.0051
70994616|NCT01263093|141498018|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.77|||||TWO_SIDED|90.0|0.72|0.83|||Mixed Models Analysis||Statistical inference was made using the test treatment of LY2216684 + clopidogrel and the reference treatment of clopidogrel alone.|||0.83|0.72|
70994617|NCT01263093|141498019|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.59|||||TWO_SIDED|90.0|0.53|0.67|||Mixed Models Analysis||Statistical inference was made using the test treatment of LY2216684 + clopidogrel and the reference treatment of clopidogrel alone.|||0.67|0.53|
70994618|NCT01263093|141498021|SUPERIORITY_OR_OTHER||Median of Paired Differences|0.0||||0.3303|TWO_SIDED|90.0|0.0|0.25|||Wilcoxon (Mann-Whitney)|||||0.25|0.00|0.3303
70994619|NCT05263921|141498078|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric means|107.35|||||TWO_SIDED|90.0|99.66|115.64||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water||115.64|99.66|
70994620|NCT05263921|141498078|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|120.73|||||TWO_SIDED|90.0|112.09|130.03||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce||130.03|112.09|
70994621|NCT05263921|141498078|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|125.04|||||TWO_SIDED|90.0|116.08|134.69||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding||134.69|116.08|
70994622|NCT05263921|141498079|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric means|108.8|||||TWO_SIDED|90.0|101.06|117.14||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water||117.14|101.06|
71099495|NCT02722330|141707662|SUPERIORITY_OR_OTHER|||||||0.014|||||||Wilcoxon Signed Rank test|||4000 Hz||||0.014
71099496|NCT02722330|141707662|SUPERIORITY_OR_OTHER|||||||0.71|||||||Wilcoxon Signed Rank test|||6000 Hz||||0.71
70994623|NCT05263921|141498079|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|120.95|||||TWO_SIDED|90.0|112.36|130.2||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce||130.20|112.36|
70994624|NCT05263921|141498079|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|127.39|||||TWO_SIDED|90.0|118.32|137.15||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding||137.15|118.32|
70994625|NCT05263921|141498080|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric means|115.1|||||TWO_SIDED|90.0|104.03|127.34||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water||127.34|104.03|
70994626|NCT05263921|141498080|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|145.6|||||TWO_SIDED|90.0|131.68|160.99||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce||160.99|131.68|
70994627|NCT05263921|141498080|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|161.48|||||TWO_SIDED|90.0|145.95|178.66||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding||178.66|145.95|
70994628|NCT05263921|141498081|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric means|110.85|||||TWO_SIDED|90.0|95.38|128.82||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water||128.82|95.38|
70994629|NCT05263921|141498081|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|106.55|||||TWO_SIDED|90.0|91.76|123.73||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce||123.73|91.76|
70994630|NCT05263921|141498081|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|107.74|||||TWO_SIDED|90.0|92.7|125.21||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding||125.21|92.70|
70994631|NCT05263921|141498082|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric means|110.19|||||TWO_SIDED|90.0|94.51|128.47||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water||128.47|94.51|
70994632|NCT05263921|141498082|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|107.17|||||TWO_SIDED|90.0|92.0|124.86||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce||124.86|92.00|
70994633|NCT05263921|141498082|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|107.83|||||TWO_SIDED|90.0|92.48|125.72||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding||125.72|92.48|
70994634|NCT05263921|141498083|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric means|108.72|||||TWO_SIDED|90.0|89.32|132.32||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water||132.32|89.32|
70994635|NCT05263921|141498083|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|109.44|||||TWO_SIDED|90.0|90.05|133.0||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce||133.00|90.05|
70994636|NCT05263921|141498083|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|117.3|||||TWO_SIDED|90.0|96.37|142.77||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding||142.77|96.37|
70994637|NCT03292952|141498110|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
70994638|NCT02667457|141498152|OTHER|||||||0.0095||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 60 minutes||||0.0095
70994639|NCT02667457|141498152|OTHER|||||||0.0029||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 120 minutes||||0.0029
70994640|NCT02667457|141498153|OTHER|||||||0.0066||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 60 minutes||||0.0066
70994641|NCT02667457|141498153|OTHER|||||||0.0334||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 120 minutes||||0.0334
71099497|NCT02722330|141707663|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon Signed Rank test|||||||0.48
71099498|NCT02722330|141707664|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon Signed Rank test|||||||0.11
70994642|NCT02667457|141498154|OTHER|||||||0.0066||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 60 minutes||||0.0066
71099499|NCT02722330|141707665|SUPERIORITY_OR_OTHER|||||||0.017|||||||Wilcoxon Signed Rank test|||SPL 50 dB||||0.017
70994643|NCT02667457|141498154|OTHER|||||||0.0301||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 120 minutes||||0.0301
70994644|NCT02667457|141498155|OTHER|||||||0.0066||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 60 minutes||||0.0066
70994645|NCT02667457|141498155|OTHER|||||||0.0387||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 120 minutes||||0.0387
71099500|NCT02722330|141707665|SUPERIORITY_OR_OTHER|||||||0.095|||||||Wilcoxon Signed Rank test|||SPL 65 dB||||0.095
70923439|NCT03416010|141338453|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference between the two groups in stress, as measured by the GAD-7, at T0 baseline, as well as at timepoint 1 (immediately following the intervention), timepoint 2 (6 weeks after the infants' birth) and timepoint 3 (6 months after the infants' birth).||||<0.001
71040217|NCT02846883|141588630|SUPERIORITY|These power estimates are based on linear regression of regulatory T-cell counts at each time point. These data will be summarized with the mean, median, standard deviation, standard error, minimum and maximum.|Mean Difference (Final Values)|81.0|||<|0.05|TWO_SIDED|95.0||||P value is adjusted for multiple comparisons|Regression, Cox|See above|Estimates for the differences in the secondary endpoints will be used to perform a power estimation using a Monte Carlo simulation method.|The primary statistical evaluation for Aim 1 will focus on the chronologically increasing counts of T-regulatory cells over time following MSC administration in both delivery groups. Using the pattern of increased counts with time and the standard deviation reported by Ito and colleagues in healthy subjects, 36 subjects provides 81.0% power to detect such a change.A p value of \<0.05 will be considered significant.||||<0.05
71040218|NCT00122447|141588680|SUPERIORITY_OR_OTHER||Slope|-0.941|STANDARD_ERROR_OF_MEAN|1.229||0.449|TWO_SIDED|95.0|-3.435|1.552||Association between treatment arm, compared to placebo, on change in hsCRP from baseline to 12 months of intervention, adjusted for age, sex, and race.|Regression, Linear|||||1.552|-3.435|0.449
71040219|NCT00122447|141588680|SUPERIORITY_OR_OTHER||Slope|-2.677|STANDARD_ERROR_OF_MEAN|1.211||0.034|TWO_SIDED|95.0|-5.133|-0.221||Association between treatment arm, compared to placebo, on change in hsCRP from baseline to 12 months of intervention, adjusted for age, sex, and race.|Regression, Linear|||||-0.221|-5.133|0.034
71040220|NCT00122447|141588680|SUPERIORITY_OR_OTHER||Slope|0.088|STANDARD_ERROR_OF_MEAN|1.21||0.943|TWO_SIDED|95.0|-2.367|2.542||Association between treatment arm, compared to placebo, on change in hsCRP from baseline to 12 months of intervention, adjusted for age, sex, and race.|Regression, Linear|||||2.542|-2.367|0.943
71040221|NCT00122447|141588681|SUPERIORITY_OR_OTHER||Slope|-0.001|STANDARD_ERROR_OF_MEAN|0.012||0.943|TWO_SIDED|95.0|-0.025|0.023||Association between treatment arm, compared to placebo, on change in FMD from baseline to 12 months of intervention, adjusted for age, sex, race, and LDL-cholesterol.|Regression, Linear|||Null hypothesis: no difference between active treatment group compared to placebo.||0.023|-0.025|0.943
71040222|NCT00122447|141588681|SUPERIORITY_OR_OTHER||Slope|0.014|STANDARD_ERROR_OF_MEAN|0.013||0.28|TWO_SIDED|95.0|-0.012|0.039||Association between treatment arm, compared to placebo, on change in FMD from baseline to 12 months of intervention, adjusted for age, sex, race, and LDL-cholesterol.|Regression, Linear|||||0.039|-0.012|0.280
71040223|NCT00122447|141588681|SUPERIORITY_OR_OTHER||Slope|0.012|STANDARD_ERROR_OF_MEAN|0.012||0.313|TWO_SIDED|95.0|-0.012|0.037||Association between treatment arm, compared to placebo, on change in FMD from baseline to 12 months of intervention, adjusted for age, sex, race, and LDL-cholesterol.|Regression, Linear|||||0.037|-0.012|0.313
71040224|NCT01453153|141588701|SUPERIORITY||percentage of participants|0.0|||||TWO_SIDED|95.0|0.0|60.0||||||||60|0|
71040225|NCT01453153|141588701|SUPERIORITY||percentage of participants|50.0|||||TWO_SIDED|95.0|7.0|93.0||||||||93|7|
71040226|NCT01453153|141588701|SUPERIORITY||percentage of participants|40.0|||||TWO_SIDED|95.0|19.0|64.0||||||||64|19|
71099501|NCT02722330|141707665|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon Signed Rank test|||SPL 80 dB||||0.57
71099502|NCT02722330|141707666|SUPERIORITY_OR_OTHER|||||||0.096|||||||Wilcoxon Signed Rank test|||SPL 50 dB||||0.096
71099503|NCT02722330|141707666|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon Signed Rank test|||SPL 65 dB||||1.00
71099504|NCT02722330|141707666|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon Signed Rank test|||SPL 80 dB||||0.41
71099505|NCT01934231|141707672|SUPERIORITY_OR_OTHER||Rate of Cure|88.5|||||TWO_SIDED|95.0|69.85|97.55|||||"The estimated parameter represents the rate of cure, calculated as (number of participants with an outcome of Cure/number of participants analyzed) \* 100."|||97.55|69.85|
71099506|NCT00382863|141707687|SUPERIORITY_OR_OTHER|||||||0.502|||||||Fisher Exact|One-sided||Null hypothesis = proportion of subjects in treatment group who successfully achieved an improvement of at least 1.0 ml/kg/min at 6 months is less than or equal to the Control group. Subjects who withdrew for cardiac-related reasons were classified as non-responders.||||0.502
71099507|NCT00382863|141707688|SUPERIORITY_OR_OTHER|||||||0.044|||||||Fisher Exact|One-sided||The null hypothesis = the proportion of subjects in the treatment group who successfully achieved an improvement of at least 45 m at 6 months from baseline is less than or equal to that of the Control group. Withdrawals due to cardiac reasons are counted as non-responders.||||0.044
71099508|NCT00382863|141707689|SUPERIORITY_OR_OTHER|||||||0.184|||||||Fisher Exact|One-sided||The null hypothesis = the proportion of treatment subjects who successfully achieved an improvement of at least 7 points at 6 months is equal to or less than that of the control group. Withdrawals due to cardiac reasons are counted as non-responders.||||0.184
71099509|NCT00382863|141707690|NON_INFERIORITY_OR_EQUIVALENCE|Estimated survival for the treatment group was 93%. Estimated survival for the control group was 91.5%. A non-inferiority margin of 7.5%. Final test alpha level of 0.04825.||||||0.012|||||||Exact binomial test|One-sided||The null hypothesis = survival in the treatment group at 12 months is not equivalent to that of the Control group.||||0.012
71099510|NCT00382863|141707691|SUPERIORITY_OR_OTHER|||||||0.052|||||||Wilcoxon (Mann-Whitney)|||Class change from baseline.||||0.052
71099511|NCT00382863|141707692|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71040227|NCT01453153|141588702|SUPERIORITY||percentage of participants|25.0|||||TWO_SIDED|95.0|1.0|81.0||||||||81|1|
71040228|NCT01453153|141588702|SUPERIORITY||percentage of participants|100.0|||||TWO_SIDED|95.0|40.0|100.0||||||||100|40|
71040229|NCT01453153|141588702|SUPERIORITY||percentage of participants|70.0|||||TWO_SIDED|95.0|46.0|88.0||||||||88|46|
71040230|NCT00799708|141588731|SUPERIORITY_OR_OTHER|||||||0.345||95.0|||||ANOVA|||||||0.345
71040231|NCT00799708|141588731|SUPERIORITY_OR_OTHER|||||||0.166||95.0|||||ANOVA|||||||0.166
71099512|NCT00382863|141707693|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.032
70923440|NCT03416010|141338453|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no statistically significant interaction between the intervention group and time.||||<0.001
70923441|NCT04788537|141338493|SUPERIORITY|Linear mixed model regression|Slope|-1.58||||0.006|TWO_SIDED||||||Mixed Models Analysis||Slope reported is for Time x Group Interaction|||||.006
71099513|NCT00382863|141707694|SUPERIORITY_OR_OTHER|||||||0.54|||||||Fisher Exact|One-sided||Improvement of at least 1.0 ml/kg/min from baseline.||||0.540
71099514|NCT00382863|141707695|SUPERIORITY_OR_OTHER|||||||0.067|||||||Fisher Exact|One-sided||Improvement of at least 45 m from baseline.||||0.067
71040232|NCT00799708|141588732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38||||0.12|TWO_SIDED|90.0|-0.16|0.92|||ANCOVA|||||0.92|-0.16|0.120
71040233|NCT02153723|141588739|OTHER|Wilcoxon signed rank sum test|Median Difference (Final Values)|21.6||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.03
71040234|NCT02153723|141588740|OTHER|Wilcoxon signed rank sum test|Median Difference (Final Values)|-2.0||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.03
71040235|NCT02153723|141588741|OTHER|Wilcoxon signed rank sum test|Median Difference (Final Values)|-0.1||||0.004|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.004
71040236|NCT02153723|141588742|OTHER|Wilcoxon signed rank sum test|Median Difference (Final Values)|15.9||||0.08|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.08
71040237|NCT02153723|141588743|OTHER|Wilcoxon signed rank sum test|Mean Difference (Final Values)|0.8||||0.86|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.86
71040238|NCT02153723|141588744|OTHER|Wilcoxon signed rank sum test|Median Difference (Final Values)|0.0||||0.44|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.44
71040239|NCT02274558|141588745|OTHER||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|-4.2|-2.0|||Mixed-effect Model Repeated Measures|||"Control for multiplicity was accomplished through the a fixed-sequence testing procedure for Week 6 outcomes:~* AIMS dyskinesia total score mean change from baseline (CFB): valbenazine 80 mg vs. placebo.~* CGI-TD mean score: VBZ 80 mg vs. PBO.~* AIMS: VBZ 40 mg vs. PBO.~* CGI-TD: VBZ 40 mg vs. PBO.~For a test result in the above list to be considered statistically significant, all of the test results higher in the list must have been significant at the 0.05 level of significance."||-2.0|-4.2|<0.0001
71040240|NCT02274558|141588745|OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.6||0.0021|TWO_SIDED|95.0|-3.0|-0.7||Nominal P-value, not adjusted for multiplicity. See comments in above statistical analysis overview regarding the fixed-sequence testing procedure to control for multiplicity.|Mixed-effect Model Repeated Measures|||||-0.7|-3.0|0.0021
71040241|NCT02274558|141588746|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0742|TWO_SIDED|95.0|-0.5|0.0|||Mixed-effect Model Repeated Measures|||||0.0|-0.5|0.0742
71040242|NCT02274558|141588746|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.056|TWO_SIDED|95.0|-0.5|0.0|||Mixed-effect Model Repeated Measures|||||0.0|-0.5|0.0560
71040243|NCT02274558|141588747|OTHER|||||||0.02|||||||Cochran-Mantel-Haenszel|||||||0.0200
71040244|NCT02274558|141588747|OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71040245|NCT02655224|141588748|SUPERIORITY|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|42.071|||<|0.0001|TWO_SIDED|95.0|5.113|346.181|||Fisher's Exact Test||Relugolix 40 mg/Placebo|||346.181|5.113|<0.0001
71040246|NCT02655224|141588749|OTHER|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|29.176|||||TWO_SIDED|95.0|3.555|239.478|||||Relugolix 40 mg/Placebo|||239.478|3.555|
71040247|NCT02655224|141588750|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Final Values)|-0.49|||||TWO_SIDED|95.0|-1.05|0.069|||||Relugolix 40 mg-Placebo|||0.069|-1.050|
71040248|NCT02655224|141588751|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Final Values)|11.96|||||TWO_SIDED|95.0|-3.201|27.112|||||Relugolix 40 mg-Placebo|||27.112|-3.201|
71040249|NCT02655224|141588752|OTHER|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|5.625|||||TWO_SIDED|95.0|1.605|19.709|||||Relugolix 40 mg/Placebo. Statistical analysis for Day 29 to 56 and Day 57 to 84, the odds ratio was calculated. For Day 1 to 28, its ratio was not calculated due to zero cell.|Day 29 to 56||19.709|1.605|
71040250|NCT02655224|141588752|OTHER|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|9.865|||||TWO_SIDED|95.0|2.784|34.955|||||Relugolix 40 mg/Placebo. Statistical analysis for Day 29 to 56 and Day 57 to 84, the odds ratio was calculated. For Day 1 to 28, its ratio was not calculated due to zero cell.|Day 57 to 84||34.955|2.784|
71040251|NCT02655224|141588753|OTHER|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|5.438|||||TWO_SIDED|95.0|1.071|27.609|||||Relugolix 40 mg/Placebo. Statistical analysis for Day 29 to 56 and Day 57 to 84, the odds ratio was calculated. For Day 1 to 28, its ratio was not calculated due to zero cell.|Day 29 to 56||27.609|1.071|
71040252|NCT02655224|141588753|OTHER|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|12.794|||||TWO_SIDED|95.0|2.603|62.88|||||Relugolix 40 mg/Placebo. Statistical analysis for Day 29 to 56 and Day 57 to 84, the odds ratio was calculated. For Day 1 to 28, its ratio was not calculated due to zero cell.|Day 57 to 84||62.880|2.603|
71040253|NCT02655224|141588754|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|0.09|||||TWO_SIDED|95.0|-0.574|0.745|||||Relugolix 40 mg-Placebo|Day 1 to 28||0.745|-0.574|
71040254|NCT02655224|141588754|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|-0.57|||||TWO_SIDED|95.0|-1.19|0.049|||||Relugolix 40 mg-Placebo|Day 29 to 56||0.049|-1.190|
71040255|NCT02655224|141588754|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|-0.54|||||TWO_SIDED|95.0|-1.074|-0.012|||||Relugolix 40 mg-Placebo|Day 57 to 84||-0.012|-1.074|
71040256|NCT02655224|141588755|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|4.17|||||TWO_SIDED|95.0|-11.507|19.839|||||Relugolix 40 mg-Placebo|Day 1 to 28||19.839|-11.507|
71099515|NCT00382863|141707696|SUPERIORITY_OR_OTHER|||||||0.031|||||||Fisher Exact|One-sided||Improvement of at least 7 points from baseline.||||0.031
71099516|NCT00382863|141707697|SUPERIORITY_OR_OTHER|||||||0.109|||||||Log Rank|||Kaplan-Meier actuarial time-to-first-event analysis||||0.109
71099517|NCT00382863|141707698|SUPERIORITY_OR_OTHER|||||||0.031|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.031
71099518|NCT00382863|141707699|SUPERIORITY_OR_OTHER|||||||0.179|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.179
71099519|NCT00382863|141707700|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.070
71099520|NCT00382863|141707701|SUPERIORITY_OR_OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.015
71099521|NCT00382863|141707702|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.032
71099522|NCT00382863|141707704|SUPERIORITY_OR_OTHER|||||||0.627|||||||Fisher Exact|Two-sided||||||0.627
71099523|NCT00382863|141707705|SUPERIORITY_OR_OTHER|||||||0.386|||||||Log Rank|||||||0.386
71099524|NCT00382863|141707706|SUPERIORITY_OR_OTHER|||||||0.154|||||||Fisher Exact|Two-sided||||||0.154
71099525|NCT00382863|141707707|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|Two-sided||||||1.000
71099526|NCT00382863|141707708|SUPERIORITY_OR_OTHER|||||||0.939|||||||Log Rank|||||||0.939
71099527|NCT00382863|141707709|SUPERIORITY_OR_OTHER|||||||0.012|||||||Fisher Exact|Two-sided||||||0.012
71099528|NCT00382863|141707710|SUPERIORITY_OR_OTHER|||||||0.001|||||||Log Rank|||||||0.001
71099529|NCT00382863|141707711|SUPERIORITY_OR_OTHER|||||||0.772|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.772
71099530|NCT02837952|141707731|SUPERIORITY||Least Square Mean Difference|72.89|||<|0.001|TWO_SIDED|95.0|50.075|95.707|||ANCOVA|||Treatment difference and 95 percent (%) confidence interval (CI) were based on LS Mean from analysis of covariance (ANCOVA) with treatment, gender, baseline categorical pain severity rating (PSR) as classification variables and baseline numerical PSR used as a continuous covariate.||95.707|50.075|<0.001
71099531|NCT02837952|141707732|SUPERIORITY||Least Square Mean Difference|26.45|||<|0.001|TWO_SIDED|95.0|19.895|33.005|||ANCOVA|||0 to 8 hours: Treatment difference and 95% CI were based on least square (LS) mean from analysis of covariance (ANCOVA) with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||33.005|19.895|< 0.001
71099532|NCT02837952|141707732|SUPERIORITY||LS Mean Difference|7.91|||<|0.001|TWO_SIDED|95.0|5.196|10.632|||ANCOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||10.632|5.196|< 0.001
71099533|NCT02837952|141707732|SUPERIORITY||LS Mean Difference|51.67|||<|0.001|TWO_SIDED|95.0|37.075|66.258|||ANCOVA|||0 to 16 hours: Treatment difference and 95% CI were based on LS mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||66.258|37.075|< 0.001
71099534|NCT02837952|141707732|SUPERIORITY||LS Mean Difference|27.32|||<|0.001|TWO_SIDED|95.0|18.139|36.508|||ANCOVA|||8 to 16 hours: Treatment difference and 95% CI were based on LS mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||36.508|18.139|< 0.001
71099535|NCT02837952|141707732|SUPERIORITY||LS Mean Difference|138.65|||<|0.001|TWO_SIDED|95.0|91.045|186.261|||ANCOVA|||0 to 48 hours: Treatment difference and 95% CI were based on LS mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||186.261|91.045|< 0.001
71099536|NCT02837952|141707733|SUPERIORITY||||||<|0.001||||||P-value Method was based on Gehan-Wilcoxon test, stratified by sex and baseline categorical PSR.|Gehan-Wilcoxon test|||||||<0.001
71099537|NCT02837952|141707734|SUPERIORITY||||||<|0.001||||||P-value Method was based on Gehan-Wilcoxon test, stratified by sex and baseline categorical PSR.|Gehan-Wilcoxon test|||||||<0.001
71099538|NCT01362530|141707735|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Cochran-Mantel-Haenszel|Stratified by age group, use of dexamethasone as an anti-emetic, and receipt of very high risk emetogenic chemotherapy.||||||<0.01
71099539|NCT01362530|141707736|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Cochran-Mantel-Haenszel|Stratified by age group, use of dexamethasone as an anti-emetic, and receipt of very high risk emetogenic chemotherapy.||||||<0.05
71099540|NCT01362530|141707737|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Cochran-Mantel-Haenszel|Stratified by age group, use of dexamethasone as an anti-emetic, and receipt of very high risk emetogenic chemotherapy.||||||<0.01
71099541|NCT01362530|141707738|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Cochran-Mantel-Haenszel|Stratified by age group, use of dexamethasone as an anti-emetic, and receipt of very high risk emetogenic chemotherapy.||||||<0.01
71099542|NCT04250363|141707766|OTHER||Odds Ratio (OR)|3.57||||0.00284|TWO_SIDED|95.0|1.85|10.6|||Regression, Logistic|||||10.6|1.85|0.00284
71099543|NCT04250363|141707766|OTHER||Odds Ratio (OR)|4.19||||0.00367|TWO_SIDED|95.0|2.0|14.8|||Regression, Logistic|||||14.8|2.00|0.00367
71099544|NCT04250363|141707766|OTHER||Odds Ratio (OR)|4.22||||0.0137|TWO_SIDED|95.0|1.9|23.7|||Regression, Logistic|||||23.7|1.90|0.0137
71099545|NCT04250363|141707766|OTHER||Odds Ratio (OR)|2.23||||0.00349|TWO_SIDED|95.0|1.47|4.48|||Regression, Logistic|||||4.48|1.47|0.00349
71099546|NCT04250363|141707766|OTHER||Odds Ratio (OR)|11.6||||0.00594|TWO_SIDED|95.0|3.19|129.0|||Regression, Logistic|||||129|3.19|0.00594
71099547|NCT00276380|141707768|OTHER||Odds Ratio (OR)|0.83||||0.52|TWO_SIDED|95.0|0.46|1.48|||Cochran-Mantel-Haenszel||The homogeneity of the Odds Ratio (OR) across centres was assessed by the Breslow Day test.|The association between treatment and response after adjustment for the pooled centres was analysed using a Cochran-Mantel-Haenszel test.||1.48|0.46|0.52
71040257|NCT02655224|141588755|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|12.7|||||TWO_SIDED|95.0|-3.098|28.494|||||Relugolix 40 mg-Placebo|Day 29 to 56||28.494|-3.098|
71040258|NCT02655224|141588755|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|11.6|||||TWO_SIDED|95.0|-3.554|26.745|||||Relugolix 40 mg-Placebo|Day 57 to 84||26.745|-3.554|
71040259|NCT04592419|141588769|NON_INFERIORITY|The maximum clinically acceptable true difference between KSI-301 and aflibercept among BRVO participants to be considered non-inferior is 4.5 ETDRS letters, i.e. the non-inferiority margin (NI) is 4.5 letters.|Adjusted mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.87||0.0004|TWO_SIDED|95.02|-3.11|0.3|||Mixed Models Analysis|MMRM model with treatment, visit, treatment × visit interaction, baseline BCVA, disease duration, and geographical location as covariates.||||0.30|-3.11|.0004
71040260|NCT04592419|141588770|NON_INFERIORITY|The maximum clinically acceptable true difference between KSI-301 and aflibercept among BRVO participants to be considered non-inferior is 4.5 ETDRS letters, i.e. the non-inferiority margin (NI) is 4.5 letters.|Adjusted mean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.9||0.0243|TWO_SIDED|95.02|-4.24|-0.71|||Mixed Models Analysis|MMRM model treatment, visit, treatment × visit interaction, RVO subtype, baseline BCVA, disease duration, and geographical location as covariates.||||-0.71|-4.24|.0243
71040261|NCT04968925|141588854|NON_INFERIORITY|A non-inferiority margin of 10% was used.|Odds Ratio (OR)|4.24|||||TWO_SIDED|95.0|0.8|22.54|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control|Phase I was not powered to test for non-inferiority for any endpoints. The data collected from this Phase was used to estimate the sample size required to achieve the primary endpoints for Phase II of the study.||22.54|0.80|
71040262|NCT04968925|141588855|NON_INFERIORITY|A non-inferiority margin of 10% was used.|Odds Ratio (OR)|3.44|||||TWO_SIDED|95.0|1.16|10.16|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control|Phase I was not powered to test for non-inferiority for any endpoints. The data collected from this Phase was used to estimate the sample size required to achieve the primary endpoints for Phase II of the study.||10.16|1.16|
71040263|NCT04968925|141588856|NON_INFERIORITY|A non-inferiority margin of 10% was used.|Odds Ratio (OR)|2.67|||||TWO_SIDED|95.0|1.05|6.76|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control|Phase I was not powered to test for non-inferiority for any endpoints. The data collected from this Phase was used to estimate the sample size required to achieve the primary endpoints for Phase II of the study.||6.76|1.05|
71099548|NCT00276380|141707769|OTHER|Comparison of treatment effect at Day 28|Odds Ratio (OR)|0.86||||0.623|TWO_SIDED|95.0|0.47|1.57|||Cochran-Mantel-Haenszel||The homogeneity of the Odds Ratio (OR) across centres was assessed by the Breslow Day test.|The association between treatment and response after adjustment for the pooled centres was analysed using a Cochran-Mantel-Haenszel test.||1.57|0.47|0.623
71099549|NCT00276380|141707769|OTHER|Comparison of treatment effect at Day 84|Odds Ratio (OR)|0.74||||0.3|TWO_SIDED|95.0|0.42|1.3|||Cochran-Mantel-Haenszel||The homogeneity of the Odds Ratio (OR) across centres was assessed by the Breslow Day test.|The association between treatment and response after adjustment for the pooled centres was analysed using a Cochran-Mantel-Haenszel test.||1.3|0.42|0.3
71099550|NCT00276380|141707771|OTHER|||||||0.207||||||Treatment effect was derived using a parametric analysis of covariance (ANCOVA) with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 28||||0.207
71040264|NCT04968925|141588857|SUPERIORITY|"The Fallback Method was used to test primary hypotheses in Phase II. An alpha of 0.167 was allocated for each test. Every successful test passed the unused alpha to the next."|Odds Ratio (OR)|1.76|||||TWO_SIDED|98.33|1.09|2.83|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control|It was calculated based on Phase I using Stroup's Method that 200 subjects were required to test superiority for each endpoint in Phase II.||2.83|1.09|
71040265|NCT04968925|141588858|SUPERIORITY|"The Fallback Method was used to test primary hypotheses in Phase II. An alpha of 0.167 was allocated for each test. Every successful test passed the unused alpha to the next."|Odds Ratio (OR)|1.52|||||TWO_SIDED|96.66|1.02|2.28|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control|It was calculated based on Phase I using Stroup's Method that 200 subjects were required to test superiority for each endpoint in Phase II.||2.28|1.02|
71040266|NCT04968925|141588859|SUPERIORITY|"The Fallback Method was used to test primary hypotheses in Phase II. An alpha of 0.167 was allocated for each test. Every successful test passed the unused alpha to the next."|Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.77|2.03|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control|It was calculated based on Phase I using Stroup's Method that 200 subjects were required to test superiority for each endpoint in Phase II.||2.03|0.77|
71099551|NCT00276380|141707771|OTHER|||||||0.59||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 84||||0.590
71099552|NCT00276380|141707771|OTHER|Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.||||||0.814|||||||ANCOVA|||Comparison of treatment effect at Day 168||||0.814
71099553|NCT00276380|141707772|OTHER|||||||0.24||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 28||||0.240
71099554|NCT00276380|141707772|OTHER|||||||0.441||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 84||||0.441
71099555|NCT00276380|141707772|OTHER|||||||0.645||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 168||||0.645
71040267|NCT00876265|141588871|NON_INFERIORITY_OR_EQUIVALENCE|If the 95% CI or the difference between LS mean (Belotero) and LS mean (Zyplast) lies entirely above -Δ, noninferiority of Belotero will be concluded (first step). If, in addition, the CI lies entirely above 0, superiority of Belotero over Zyplast will be concluded (second step).|Adjusted (LS) mean difference|0.048|STANDARD_ERROR_OF_MEAN|0.139||0.733|TWO_SIDED|95.0|-0.228|0.323||Treatment term and all significant (p ≤ 0.10) covariate and covariate by treatment interactions will be retained in the final ANCOVA model. From the final ANCOVA model, adjusted (LS) means for Belotero and Zyplast was computed.|ANCOVA|||"The null, H0, and the alternative hypothesis, H1, are as follows:~H0(1): adjusted mean(dadj\[i\]) ≤ -Δ versus H1(1): adjusted mean(dadj\[i\]) \> -Δ H0(2): adjusted mean(dadj\[i\]) ≤ 0 versus H1(2): adjusted mean(dadj\[i\]) \> 0 The sample size calculation was based on the following assumptions: Type I error α = 0.025 (one sided); Power = 90%; Non-inferiority margin Δ = 0.25; Estimated common standard deviation (SD) = 0.75. Under these assumptions, a total of 100 evaluable subjects were needed."||0.323|-0.228|0.733
71040268|NCT02754492|141588872|OTHER|A procedure is a success if the subject's platelet product has a residual WBC count of \< 5.0 × 10\^6 for the single platelet product group. The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|0.989|STANDARD_ERROR_OF_MEAN|0.0107|||ONE_SIDED|95.0|0.95|||||||Up to 350 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|||0.950|
71040269|NCT02754492|141588872|OTHER|A procedure is a success if the subject's platelet product has a residual WBC count of \< 8.0 × 10\^6 for the double platelet product group, or \< 5.0 × 10\^6 for each transfusable unit . The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 350 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|||0.968|
71040270|NCT02754492|141588872|OTHER|A procedure is a success if the subject's platelet product has a residual WBC count of \< 12.0 × 10\^6 for the triple platelet product group, or \< 5.0 × 10\^6 for each transfusable unit . The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 350 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|||0.968|
71040271|NCT02754492|141588873|OTHER|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 3.0 × 10\^11 for the single platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|0.989|STANDARD_ERROR_OF_MEAN|0.0107|||ONE_SIDED|95.0|0.95|||||||Up to 350 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|||0.950|
71040272|NCT02754492|141588873|OTHER|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 6.2 × 10\^11 for the double platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 350 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|||0.968|
71099556|NCT00276380|141707773|OTHER|||||||0.623||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 28||||0.623
71099557|NCT00276380|141707773|OTHER|||||||0.338||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 84||||0.338
71099558|NCT00276380|141707773|OTHER|||||||0.828||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates|ANCOVA|||Comparison of treatment effect at Day 168||||0.828
71099559|NCT04829214|141707777|SUPERIORITY||Risk Difference (RD)|-10.2|STANDARD_ERROR_OF_MEAN|7.9|=|0.385|TWO_SIDED|95.0|-26.0|5.0|||Mantel Haenszel|||The percentage of responders will be compared between the two groups using the Mantel Haenszel test controlling for category of duration of tinnitus and category of baseline TFI overall score. The primary efficacy analysis will be conducted for the comparison of OTO-313 and placebo, using a 2-sided test and an alpha level of 5%. The 95% confidence intervals (CI) around the common risk difference will also be provided.||5|-26|=0.385
71099560|NCT02571244|141707796|SUPERIORITY||Risk Ratio (RR)|1.35|||||TWO_SIDED|95.0|0.99|1.85||||||||1.85|0.99|
71099561|NCT02571244|141707797|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||||||0.28
71099562|NCT02571244|141707798|SUPERIORITY|||||||0.42|||||||Fisher Exact|||||||0.42
71099563|NCT02571244|141707799|SUPERIORITY||Risk Ratio (RR)|1.45|||||TWO_SIDED|95.0|1.08|1.95||||||||1.95|1.08|
71099564|NCT02571244|141707800|SUPERIORITY||Risk Ratio (RR)|1.44|||||TWO_SIDED|95.0|1.07|1.92||||||||1.92|1.07|
71099565|NCT03888482|141707817|NON_INFERIORITY|Non-inferiority margin = 0.05|Least Squares Mean Difference|0.0|||||ONE_SIDED|95.0||0.01|||Mixed effects repeated measures model|Mixed effects repeated measures model with terms for lens, period and sequence as fixed effects and subject as a random effect.|Difference = DDT2 - Clariti|||0.01||
71099566|NCT03907579|141707818|SUPERIORITY|||||||0.0001|||||||Wilcoxon Signed Rank Test|z= -3.861||||||0.0001
70923442|NCT00837369|141338494|SUPERIORITY||||||<|0.001|TWO_SIDED|95.0||||Compare the differences in sensitivity between myocardial perfusion and wall motion for detecting stenosis.|Chi-squared|||||||<0.001
70923443|NCT00837369|141338494|SUPERIORITY||||||<|0.001||||||Compare the sensitivity of myocardial perfusion in detecting stenosis within the first 4 minutes after regadenoson bolus injection to that of wall motion|Chi-squared|||||||<0.001
70923444|NCT04899115|141338501|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||0.13
70923445|NCT04899115|141338502|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|Wilcoxon was used because data was not normal.||||||0.48
70923446|NCT05161715|141338515|OTHER|||||||0.425||||||No multiple testing correction was performed|Wilcoxon (Mann-Whitney)|||||||0.425
70923447|NCT05161715|141338516|OTHER|||||||0.0002||||||No multiple testing correction was performed|Wilcoxon (Mann-Whitney)|||||||0.0002
70923448|NCT05161715|141338517|OTHER|||||||0.0424||||||No multiple testing correction was performed|Wilcoxon (Mann-Whitney)|||||||0.0424
70923449|NCT05161715|141338518|OTHER|||||||0.001||||||No multiple testing correction was performed|Wilcoxon (Mann-Whitney)|||||||0.001
70923450|NCT05161715|141338523|OTHER|||||||0.556||||||No multiple testing correction was performed|Wilcoxon (Mann-Whitney)|||||||0.556
70923451|NCT03743636|141338524|SUPERIORITY||Mean Difference (Final Values)|17.57||||0.0775|ONE_SIDED|90.0|1.77||||Mixed Models Analysis||||||1.77|0.0775
71099567|NCT03319654|141707860|OTHER|A generalized estimating equation (GEE)-model with an exchangeable correlation structure and a logit link function was used to analyze the probability of live birth and clinical pregnancy respectively. All IUI cycles are used in this model with correction for the fact that cycles of the same couple are not independent.|Odds Ratio (OR)|0.94||||0.04|TWO_SIDED|95.0|0.9|0.9985|||GEE-model|||The null hypothesis is: there is no association between % total Sperm DNA Fragmentation and live birth.||0.9985|0.90|0.04
70923452|NCT03743636|141338525|SUPERIORITY||Mean Difference (Final Values)|3.65||||0.3762|ONE_SIDED|90.0|-11.24||||Mixed Models Analysis||||||-11.24|0.3762
70923453|NCT03743636|141338526|SUPERIORITY||Mean Difference (Final Values)|22.42||||0.0294|ONE_SIDED|90.0|7.31||||Mixed Models Analysis||||||7.31|0.0294
70923454|NCT03743636|141338527|SUPERIORITY||Mean Difference (Final Values)|20.63||||0.0336|ONE_SIDED|90.0|6.26||||Mixed Models Analysis||||||6.26|0.0336
70923455|NCT03743636|141338528|SUPERIORITY||Mean Difference (Final Values)|-1.78||||0.562|ONE_SIDED|90.0|-16.51||||Mixed Models Analysis||||||-16.51|0.5620
70923456|NCT03743636|141338529|SUPERIORITY||Mean Difference (Final Values)|-13.93||||0.8797|ONE_SIDED|90.0|-29.15||||Mixed Models Analysis||||||-29.15|0.8797
70923457|NCT03743636|141338530|SUPERIORITY||Mean Difference (Final Values)|2.06||||0.0752|ONE_SIDED|90.0|0.24||||ANCOVA||||||0.24|0.0752
70923458|NCT03743636|141338531|SUPERIORITY||Mean Difference (Final Values)|-7.1||||0.8703|ONE_SIDED|90.0|-15.19||||ANCOVA||||||-15.19|0.8703
70923459|NCT03743636|141338532|SUPERIORITY||Mean Difference (Final Values)|10995.0||||0.1402|ONE_SIDED|90.0|-2078.0||||ANCOVA||||||-2078|0.1402
70923460|NCT03743636|141338533|SUPERIORITY||Mean Difference (Final Values)|1.74||||0.1249|ONE_SIDED|90.0|-0.21||||ANCOVA||||||-0.21|0.1249
70923461|NCT03743636|141338534|SUPERIORITY||Mean Difference (Final Values)|-5.05||||0.8039|ONE_SIDED|90.0|-12.62||||ANCOVA||||||-12.62|0.8039
70923462|NCT03743636|141338535|SUPERIORITY||Mean Difference (Final Values)|-842.0||||0.5352|ONE_SIDED|90.0|-13125.0||||ANCOVA||||||-13125|0.5352
70923463|NCT03743636|141338536|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.5777|ONE_SIDED|90.0|-2.46||||ANCOVA||||||-2.46|0.5777
70923464|NCT03743636|141338537|SUPERIORITY||Mean Difference (Final Values)|2.06||||0.3662|ONE_SIDED|90.0|-5.69||||ANCOVA||||||-5.69|0.3662
70923465|NCT03743636|141338538|SUPERIORITY||Mean Difference (Final Values)|-11837.0||||0.8866|ONE_SIDED|90.0|-24396.0||||ANCOVA||||||-24396|0.8866
70923466|NCT03743636|141338539|SUPERIORITY|Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|Mean Difference (Final Values)|25.25||||0.0153|ONE_SIDED|90.0|10.43|||The a priori statistical analysis plan defined a one-sided P value of \< 0.10 to define statistical significance.|Mixed Models Analysis|||Mixed models for repeated measures were used to compare 3-month change in 6MW distance between the NR/resveratrol vs placebo groups and between the NR alone vs placebo groups using baseline, 3-month, and 6-month values, adjusted for age, sex, race, and baseline 6MW.|||10.43|0.0153
70923467|NCT03743636|141338540|SUPERIORITY|Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|Mean Difference (Final Values)|14.05||||0.1195|ONE_SIDED|90.0|-1.25||||Mixed Models Analysis|||Mixed models for repeated measures were used to compare 6-month change in 6MW distance between the NR/resveratrol vs placebo groups and between the NR alone vs placebo groups using baseline, 3-month, and 6-month values, adjusted for age, sex, race, and baseline 6MW.|||-1.25|0.1195
70923468|NCT03743636|141338541|SUPERIORITY||Mean Difference (Final Values)|2.06||||0.0752|ONE_SIDED|90.0|0.24|||The a priori statistical analysis plan defined a one-sided P value of \< 0.10 to define statistical significance.|ANCOVA|||Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||0.24|0.0752
70923469|NCT03743636|141338542|SUPERIORITY||Mean Difference (Final Values)|-7.1||||0.8703|ONE_SIDED|90.0|-15.19||||ANCOVA|||Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-15.19|0.8703
70923470|NCT03743636|141338543|SUPERIORITY||Mean Difference (Final Values)|10995.0||||0.1402|ONE_SIDED|90.0|-2078.0||||ANCOVA|||Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-2078|0.1402
70923471|NCT03743636|141338544|SUPERIORITY||Mean Difference (Final Values)|-35.13||||0.8401|ONE_SIDED|90.0|-81.2||||ANCOVA||||||-81.20|0.8401
70923472|NCT03743636|141338545|SUPERIORITY||Mean Difference (Final Values)|11.14||||0.0602|ONE_SIDED|90.0|2.16||||ANCOVA|||Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||2.16|0.0602
70923473|NCT03743636|141338546|SUPERIORITY||Mean Difference (Final Values)|5.21||||0.2378|ONE_SIDED|90.0|-4.47||||ANCOVA||||||-4.47|0.2378
70923474|NCT03743636|141338547|SUPERIORITY||Mean Difference (Final Values)|6.05||||0.1589|ONE_SIDED|90.0|-1.86||||ANCOVA|||Mixed model for repeated measures is applied to 3 groups comparisons. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-1.86|0.1589
70923475|NCT03743636|141338547|SUPERIORITY||Mean Difference (Final Values)|11.14||||0.0602|ONE_SIDED|90.0|2.16||||ANCOVA|||Mixed model for repeated measures is applied to 3 groups comparisons. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||2.16|0.0602
70923476|NCT03743636|141338548|SUPERIORITY||Mean Difference (Final Values)|10.25||||0.3724|ONE_SIDED|90.0|-31.79||||ANCOVA|||Mixed model for repeated measures is applied to 3 groups comparisons. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-31.79|0.3724
70923477|NCT03743636|141338548|SUPERIORITY||Mean Difference (Final Values)|-35.13||||0.8401|ONE_SIDED|90.0|-81.2||||ANCOVA|||Mixed model for repeated measures is applied to 3 groups comparisons. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-81.20|0.8401
70923478|NCT03743636|141338549|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.5558|ONE_SIDED|90.0|-9.52||||ANCOVA|||Mixed model for repeated measures is applied to 3 groups comparisons. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-9.52|0.5558
70923479|NCT03743636|141338549|SUPERIORITY||Mean Difference (Final Values)|5.21||||0.2378|ONE_SIDED|90.0|-4.47||||ANCOVA|||Mixed model for repeated measures is applied to 3 groups comparisons. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-4.47|0.2378
70923480|NCT03743636|141338550|SUPERIORITY||Mean Difference (Final Values)|-2.71||||0.7112|ONE_SIDED|90.0|-8.97||||ANCOVA||||||-8.97|0.7112
70923481|NCT03743636|141338551|SUPERIORITY||Mean Difference (Final Values)|-7.4||||0.9449|ONE_SIDED|90.0|-13.31||||ANCOVA||||||-13.31|0.9449
70923482|NCT03743636|141338552|SUPERIORITY||Mean Difference (Final Values)|-0.48||||0.5409|ONE_SIDED|90.0|-6.57||||ANCOVA||||||-6.57|0.5409
70923483|NCT03743636|141338553|SUPERIORITY||Mean Difference (Final Values)|-3.35||||0.7814|ONE_SIDED|90.0|-8.89||||ANCOVA||||||-8.89|0.7814
70923484|NCT03743636|141338554|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.5884|ONE_SIDED|90.0|-7.07||||ANCOVA||||||-7.07|0.5884
70923485|NCT03743636|141338555|SUPERIORITY||Mean Difference (Final Values)|4.05||||0.1787|ONE_SIDED|90.0|-1.6||||ANCOVA||||||-1.60|0.1787
70923486|NCT03743636|141338556|SUPERIORITY||Mean Difference (Final Values)|-2.71||||0.7112|ONE_SIDED|90.0|-8.97||||ANCOVA|||Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-8.97|0.7112
70923487|NCT03743636|141338557|SUPERIORITY||Mean Difference (Final Values)|-7.4||||0.9449|ONE_SIDED|90.0|-13.31||||ANCOVA|||Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-13.31|0.9449
70923488|NCT00739648|141338602|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09||||0.7282|TWO_SIDED|90.0|0.86|1.39|||Regression, Linear|negative binomial regression model||||1.39|0.86|0.7282
70923489|NCT00739648|141338604|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-15.2||||0.9768|TWO_SIDED|90.0|-27.8|-2.66|||Mixed Models Analysis|||||-2.66|-27.8|0.9768
70923490|NCT00739648|141338605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.3||||0.9464|TWO_SIDED|90.0|-24.9|0.26|||Mixed Models Analysis|||||0.26|-24.9|0.9464
70923491|NCT01757665|141338606|SUPERIORITY||percent of patients|0.1|||||ONE_SIDED|95.0||0.7|||||Upper 95% CI was calculated by the method of Clopper and Pearson, using the Beta distribution with parameters x + 1 and n - x where x is the number of SVD events by POD 390 and n is the number of subjects followed at the 1 year assessment.|The null hypothesis is that the rate of structural valve deterioration at one year is greater than 1%. The alternative hypothesis is that this rate is less than 1%.||0.7||
70923492|NCT05387447|141338652|OTHER|||||||0.05|||||||Z score|||||||.05
70923493|NCT05387447|141338653|OTHER|||||||0.05|||||||Z score|||||||.05
70923494|NCT05387447|141338655|OTHER|||||||0.05|||||||Z score|||||||.05
70923495|NCT05387447|141338656|OTHER|||||||0.05|||||||Z score|||||||.05
70923496|NCT03391466|141338660|SUPERIORITY|One-sided p-value based on log-rank test stratified by response to first-line therapy and second-line age-adjusted International Prognostic Index (IPI) as data collected on case report forms.|Hazard Ratio (HR)|0.398|||<|0.0001|TWO_SIDED|95.0|0.308|0.514||Stratified (randomization factors) log-rank p-value.|Log Rank|Stratified (randomization stratification factors) log-rank test.|Hazard ratio (95% confidence interval (CI)), stratified using randomization stratification factors.|||0.514|0.308|<0.0001
70923497|NCT03391466|141338661|SUPERIORITY|One-sided p-value based on CMH test, one-sided tailed test, stratified by response to first-line therapy and second-line age-adjusted IPI as data collected on case report forms.|Difference in ORR|33.1|||<|0.0001|TWO_SIDED|95.0|23.2|42.1||Stratified (randomization factor) CMH test p-value.|Cochran-Mantel-Haenszel|Stratified (randomization factor) CMH test.|Difference in ORR (95% CI)|||42.1|23.2|<0.0001
70994646|NCT02667457|141498156|OTHER|||||||0.0359||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 60 minutes||||0.0359
71099568|NCT03319654|141707860|OTHER||Area under the ROC curve|0.576|||>|0.05|TWO_SIDED||||||Receiver Operating Characteristics curve|||||||>0.05
71099569|NCT01725308|141707867|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-2.4||||0.034|TWO_SIDED|95.0|-4.7|-0.2|||ANCOVA|||An analysis of covariance (ANCOVA) using a model where the total MADRS score at baseline is a covariate and the treatment group and bipolar disorder diagnosis (Type I/ II) are fixed effects.||-0.2|-4.7|0.034
71099570|NCT01725308|141707874|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.7||||0.033|TWO_SIDED|95.0|-3.3|-0.1|||ANCOVA|||At End of Treatment Period I/Week 8: An analysis of covariance (ANCOVA) using a model where the total HAM-D17 score at baseline is a covariate and the treatment group and bipolar disorder diagnosis (Type I/II) are fixed effects.||-0.1|-3.3|0.033
71040273|NCT02754492|141588873|OTHER|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 9.3 × 10\^11 for the triple platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 350 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|||0.968|
71040274|NCT00487695|141588884|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED|95.0|||||Wilcoxon signed rank|||Our hypothesis was that the yield for neoplasia would be higher using confocal laser endomicroscopy compared to standard endoscopy. The null hypothesis would be that there is no difference in yield for neoplasia when CLE is used compared to standard endoscopy. We estimated that the yield for neoplasia would increase from 10% to 40% using CLE and the calculated sample size was 37. We planned to enroll 48 patients to allow for possible dropouts.||||0.01
71040275|NCT00487695|141588885|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89||95.0|||||Wilcoxon signed-rank|||The number of biopsies showing neoplasia was determined for each procedure (confocal laser endomicroscopy, standard EGD). These were compared.||||0.89
71099571|NCT04128228|141707912|OTHER|"Single group: All individuals with alcohol use disorder received the same treatment.~Brain responses were examined at baseline in individuals with alcohol use disorder (AUD) with and without early trauma (AUD/ET, AUD/NT), as well as in moderate drinkers (MD) with and without early trauma (MD/ET, MD/NT)."|F value for the 2 X 2 Group Interaction|5.5|||<|0.05|TWO_SIDED|||||A 2 × 2 × 3 Linear Mixed Model was conducted with Early Trauma Group (ET, NT) and Drinking Group (AUD, MD) as between-subjects factors, and Condition (stress, alcohol, neutral) as the within-subjects factor.|Linear Mixed Model|||A regions of interest (ROI) analysis was conducted to evaluate brain activity in the right ventromedial prefrontal cortex (VmPFC, BA10), a region identified a priori. The VmPFC ROI was defined using the Yale-Brodmann atlas in the BioImage Suite application, from which the beta value for the VmPFC ROI was obtained for a Linear Mixed Model analysis.||||<0.05
71099572|NCT04128228|141707913|OTHER|Single group (all individuals with alcohol use disorder received the same treatment). Hormone responses were examined at baseline in individuals with alcohol use disorder (AUD) with and without early trauma (AUD/ET, AUD/NT), as well as in moderate drinkers (MD) with and without early trauma (MD/ET, MD/NT).|F value|4.79|||<|0.01|TWO_SIDED||||||ANOVA|||||||<0.01
71099573|NCT04128228|141707914|OTHER|Single Group|Hazard Ratio (HR)|0.71|||<|0.05|TWO_SIDED|95.0|0.53|0.95|||Regression, Cox|||||.95|.53|<0.05
71099574|NCT04128228|141707915|OTHER|Single Group. All individuals with alcohol use disorder received the same treatment.|t value|-3.35|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
71099575|NCT04128228|141707916|OTHER|Single Group (All individuals with alcohol use disorder received the same treatment.)|t value|-2.6|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71099576|NCT03511209|141707917|SUPERIORITY||Odds Ratio (OR)|2.13|STANDARD_ERROR_OF_MEAN|0.85||0.056|TWO_SIDED|95.0|0.98|4.64|||Regression, Logistic|||Compared CBTI plus Taper method A to CBTI plus Taper method B||4.64|0.98|0.056
71099577|NCT03511209|141707918|SUPERIORITY||Mean Difference (Net)|-1.06|STANDARD_ERROR_OF_MEAN|1.27||0.405|TWO_SIDED|95.0|-3.57|1.44|||Mixed Models Analysis|Interaction contrast of Treatment Group (CBTI plus Taper method A vs. CBTI plus Taper method B) by Time (6 Months vs. Baseline)||||1.44|-3.57|0.405
71099578|NCT03163264|141707919|SUPERIORITY||Mean Difference (Net)|0.05||||0.05|TWO_SIDED|95.0|0.0|3.45||"Statistical test was 2 sided with p\<0.05 indicating statistical significance. Note: Estimated p-value was calculated at 0.050"|Mixed Models Analysis|This analysis was in our grant and protocol paper but was added late to clinicaltrials.gov.||||3.45|0|0.050
71099579|NCT03163264|141707919|SUPERIORITY||Mean Difference (Net)|0.05||||0.05|TWO_SIDED|||||"Statistical test was 2 sided with p\<0.05 indicating statistical significance. Note: Estimated p-value was calculated at 0.05"|Wilcoxon (Mann-Whitney)|The investigators will also use repeated measures modeling based on mixed models using baseline and follow up data to adjust for characteristics||||||0.05
71099580|NCT03163264|141707920|SUPERIORITY||Mean Difference (Net)|0.069||||0.069|TWO_SIDED|95.0|-0.13|3.39||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Mixed Models Analysis|This analysis was in our grant and protocol paper but was added late to clinicaltrials.gov.||||3.39|-0.13|0.069
71099581|NCT03163264|141707920|SUPERIORITY||Mean Difference (Final Values)|1.53||||0.028|TWO_SIDED|95.0|0.21|3.76||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Wilcoxon (Mann-Whitney)|The investigators will also use repeated measures modeling based on mixed models using baseline and follow up data to adjust for characteristics||||3.76|0.21|0.028
71099582|NCT03163264|141707921|SUPERIORITY||Percent Difference|11.18||||0.033|TWO_SIDED|95.0|0.92|21.45|||Mixed Models Analysis|||||21.45|0.92|0.033
71099583|NCT03163264|141707922|SUPERIORITY||Percent Difference|11.08||||0.073|TWO_SIDED|95.0|-1.05|23.2||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Mixed Models Analysis||Adjusted|||23.2|-1.05|0.073
71099584|NCT03163264|141707924|SUPERIORITY||Mean Difference (Final Values)|0.72||||0.065|TWO_SIDED|95.0|-0.05|1.48||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Mixed Models Analysis|||||1.48|-0.05|0.065
71040276|NCT00487695|141588886|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||wilcoxon signed rank test|||The null hypothesis would be that CLE does not decrease the number of biopsies needed to make a diagnosis compared to standard endoscopy||||0.002
70994647|NCT02667457|141498156|OTHER|||||||0.0022||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 120 minutes||||0.0022
70994648|NCT02475850|141498161|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.245|TWO_SIDED|95.0|0.8|1.06||p\<0.05 threshold (primary outcome)|Regression, Cox|multistate model accounting for death as a semi-competing risk||||1.06|0.80|0.245
70994649|NCT02475850|141498162|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.004|TWO_SIDED|99.0|0.83|0.99||p\< 0.01 threshold (secondary outcome)|Regression, Cox|||||0.99|0.83|0.004
70994650|NCT02475850|141498164|SUPERIORITY||Difference in least-squared means across|0.72|STANDARD_ERROR_OF_MEAN|0.71||0.309|TWO_SIDED|99.0|-1.1|2.54||p \< 0.01 threshold (secondary outcome)|Mixed Models Analysis|random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness||||2.54|-1.10|0.309
70994651|NCT02475850|141498165|SUPERIORITY||Least squares means|0.59||||0.528|TWO_SIDED|99.0|-1.8|0.93||p \< 0.01 threshold (secondary outcome)|Mixed Models Analysis|random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness||||0.93|-1.80|0.528
70994652|NCT02475850|141498166|SUPERIORITY||Least squares means|-0.9|STANDARD_ERROR_OF_MEAN|0.43||0.037|TWO_SIDED|99.0|-2.0|0.2||p \< 0.01 threshold (secondary outcome)|Mixed Models Analysis|random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness|Difference in least-squared means across all follow-up (repeated measures: 12 months/24 months)|||0.20|-2.00|0.037
70994653|NCT02475850|141498167|SUPERIORITY||Least squares means|-1.19|STANDARD_ERROR_OF_MEAN|0.45||0.009|TWO_SIDED|99.0|-2.36|-0.02||p\<0.01 threshold (secondary outcome)|Mixed Models Analysis|random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness||||-0.02|-2.36|0.009
70994654|NCT02475850|141498168|SUPERIORITY||Least squares means|-0.07|STANDARD_ERROR_OF_MEAN|0.51||0.897|TWO_SIDED|99.0|-1.38|1.25||p \<0.01 threshold (secondary outcome)|Mixed Models Analysis|random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness|Difference in least-squared means across all follow-up (repeated measures: 12 months, 24 months)|||1.25|-1.38|0.897
71099585|NCT03163264|141707925|SUPERIORITY||Mean Difference (Final Values)|0.42||||0.378|TWO_SIDED|95.0|-0.52|1.37||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Mixed Models Analysis|||||1.37|-0.52|0.378
71099586|NCT03163264|141707927|SUPERIORITY||Mean Difference (Final Values)|8.35||||0.911|TWO_SIDED|95.0|-138.25|154.95||Statistical test was 2 sided with p\<0.05 indicating statistical significance|Mixed Models Analysis|||||154.95|-138.25|0.911
70994655|NCT01746940|141498172|SUPERIORITY_OR_OTHER|||||||0.1088||||||One-sided p-value|Fisher Exact|||The null hypothesis is that the proportions of treatment group successes are equal.||||0.1088
70994656|NCT01746940|141498172|SUPERIORITY_OR_OTHER|||||||0.0005||||||One-sided p-value|Fisher Exact|||The null hypothesis is that the proportions of treatment group successes are equal.||||0.0005
70994657|NCT02700919|141498176|SUPERIORITY|||||||0.012|||||||Log Rank|||Change from Baseline on Day 7||||0.012
70994658|NCT02700919|141498176|SUPERIORITY||||||<|0.001|||||||Log Rank|||Change from Baseline on Day 7||||<0.001
70994659|NCT02700919|141498176|SUPERIORITY|||||||0.102|||||||Log Rank|||Change from Baseline on Day 7||||0.102
70994660|NCT02700919|141498176|SUPERIORITY||Mean Difference (Final Values)|0.027||||0.507|TWO_SIDED|95.0|-0.053|0.107|||Mixed Models Analysis|||Day 7||0.107|-0.053|0.507
70994661|NCT02700919|141498176|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.148|TWO_SIDED|95.0|-0.021|0.136|||Mixed Models Analysis|||Day 7||0.136|-0.021|0.148
70994662|NCT02700919|141498176|SUPERIORITY||Mean Difference (Final Values)|-0.031||||0.443|TWO_SIDED|95.0|-0.109|0.048|||Mixed Models Analysis|||Day 7||0.048|-0.109|0.443
70994663|NCT02700919|141498180|SUPERIORITY|||||||0.399|||||||Log Rank|||||||0.399
70994664|NCT02700919|141498180|SUPERIORITY|||||||0.091|||||||Log Rank|||||||0.091
70994665|NCT02700919|141498180|SUPERIORITY|||||||0.437|||||||Log Rank|||||||0.437
70994666|NCT02700919|141498184|SUPERIORITY|||||||0.72|||||||Log Rank|||||||0.720
70994667|NCT02700919|141498184|SUPERIORITY|||||||0.298|||||||Log Rank|||||||0.298
70994668|NCT02700919|141498184|SUPERIORITY|||||||0.47|||||||Log Rank|||||||0.470
70994669|NCT01517412|141498210|NON_INFERIORITY_OR_EQUIVALENCE|A step-down procedure was used to control the type I error: non-inferiority of lixisenatide prior to the main meal of the day versus lixisenatide prior to breakfast was tested first. If non-inferiority was established, then a test of superiority of lixisenatide prior to the main meal of the day over lixisenatide prior to breakfast was to be performed. The non-inferiority was assessed using upper bound of 2-sided 95% CI at a level of ≤0.4%.|Least square (LS) mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.079|||TWO_SIDED|95.0|-0.067|0.242|||||Lixisenatide Main Meal vs Lixisenatide Breakfast|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of screening HbA1c (\<8.0%, ≥8.0%), randomization strata of main meal of the day and country as fixed effects and baseline HbA1c value as a covariate.||0.242|-0.067|
70994670|NCT01517412|141498210|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.079||0.2664|TWO_SIDED|||||Threshold for significance at 0.05 level.|ANCOVA||Lixisenatide Main Meal vs Lixisenatide Breakfast|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of screening HbA1c (\<8.0%, ≥8.0%), randomization strata of main meal of the day and country as fixed effects and baseline HbA1c value as a covariate. A step-down procedure was used to control the type I error. The superiority was assessed by comparing the p-value at significance level = 0.05.||||0.2664
70994671|NCT01061736|141498260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.99||||0.1155|TWO_SIDED|95.0|0.85|4.64||Threshold for significance = 0.05.|Cochran-Mantel-Haenszel|||Analysis was performed using two-sided Cochran-Mantel-Haenszel test. Pairwise comparisons of the response rates between each dose of sarilumab and placebo were derived. The multiplicity issues were addressed by using the Hommel-procedure.||4.64|0.85|0.1155
70994672|NCT01061736|141498260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.84||||0.0041|TWO_SIDED|95.0|1.53|9.63||Threshold for significance = 0.05.|Cochran-Mantel-Haenszel|||||9.63|1.53|0.0041
71099587|NCT03163264|141707928|SUPERIORITY||Mean Difference (Final Values)|32.83||||0.648|TWO_SIDED|95.0|-108.15|173.81||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Mixed Models Analysis|||||173.81|-108.15|0.648
71099588|NCT03163264|141707929|SUPERIORITY||Percent Difference|10.32||||0.736|TWO_SIDED|95.0|-49.73|70.37||Statistical test was 2 sided with p\<0.05 indicating statistical significance|Mixed Models Analysis|||||70.37|-49.73|0.736
71099589|NCT03163264|141707930|SUPERIORITY||Percent Difference|19.36||||0.53|TWO_SIDED|95.0|-41.09|79.8||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Mixed Models Analysis|||||79.8|-41.09|0.53
71099590|NCT03000166|141707938|SUPERIORITY|||||||0.22|||||||Mixed Models Analysis|||||||0.22
71099591|NCT03000166|141707939|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||||||0.40
71099592|NCT03000166|141707940|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||||||0.17
71099593|NCT03000166|141707941|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
70994673|NCT01061736|141498260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.7119|TWO_SIDED|95.0|0.52|2.61||Threshold for significance = 0.05.|Cochran-Mantel-Haenszel|||||2.61|0.52|0.7119
70994674|NCT01061736|141498260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38||||0.0363|TWO_SIDED|95.0|1.06|5.35||Threshold for significance = 0.05.|Cochran-Mantel-Haenszel|||||5.35|1.06|0.0363
70994675|NCT01061736|141498260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.34||||0.0426|TWO_SIDED|95.0|1.03|5.29||Threshold for significance = 0.05.|Cochran-Mantel-Haenszel|||||5.29|1.03|0.0426
71099594|NCT04565756|141707978|OTHER|||||||||||||||||Since the primary objective of the study was to evaluate ocular safety and tolerability, no formal hypothesis testing was performed for any continuous or categorical variables. All statistical analyses were descriptive in nature and any statistical inferences were carried out according to the analysis plan and interpreted in view of the exploratory nature of the study.|Since the primary objective of the study was to evaluate ocular safety and tolerability, no formal hypothesis testing was performed for any continuous or categorical variables.|||
71099595|NCT05226884|141708000|NON_INFERIORITY|Non-inferiority defined as within 0.1 LogMAR (1 line on Snellen Chart).|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Normality was assumed if skewness was ±2 and kurtosis was ±7. Non-inferiority was confirmed before further statistical testing.||||||<0.05
71099596|NCT05226884|141708001|NON_INFERIORITY|Non-inferiority defined as within 0.1 LogMAR (1 line on Snellen Chart).|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Normality was assumed if skewness was ±2 and kurtosis was ±7. Non-inferiority was confirmed before further statistical testing.||||||<0.05
71099597|NCT05226884|141708002|NON_INFERIORITY|Non-inferiority defined as within 0.1 LogMAR (1 line on Snellen Chart).|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Normality was assumed if skewness was ±2 and kurtosis was ±7. Non-inferiority was confirmed before further statistical testing.||||||<0.05
71099598|NCT05226884|141708003|NON_INFERIORITY|Non-inferiority defined as within 0.1 LogMAR (1 line on Snellen Chart).|||||||||||||||||The defocus curve is generated based on measurements over a dioptric range.|||
71099599|NCT05226884|141708004|NON_INFERIORITY|Non-inferiority defined as within 0.1 LogMAR (1 line on Snellen Chart).|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Normality was assumed if skewness was ±2 and kurtosis was ±7. Non-inferiority was confirmed before further statistical testing.||||||<0.05
71099600|NCT00066937|141708048|OTHER||||||<|0.05|||||||ANOVA|Repeated measures ANOVAs compared baseline to each timepoint||||||<.05
70994676|NCT01061736|141498261|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.773|||<|0.0001|TWO_SIDED|95.0|2.077|3.703||Threshold for significance = 0.025.|Cochran-Mantel-Haenszel|||Analysis was performed using two-sided Cochran-Mantel-Haenszel test. Pairwise comparisons of the response rates between each dose of sarilumab and placebo was derived. The multiplicity issues for part B were addressed by using a Bonferroni correction for each dose together with a hierarchical testing procedure across the 3 co-primary and the main secondary endpoints. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level.||3.703|2.077|<0.0001
70994677|NCT01061736|141498261|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.975|||<|0.0001|TWO_SIDED|95.0|2.957|5.344||Threshold for significance = 0.025.|Cochran-Mantel-Haenszel|||||5.344|2.957|<0.0001
70994678|NCT01061736|141498262|SUPERIORITY_OR_OTHER||LS mean difference|-0.235|||<|0.0001|TWO_SIDED|95.0|-0.312|-0.157||Threshold for significance = 0.025.|Mixed Models Analysis|||Analysis was performed using a mixed model for repeated measures (MMRM). Differences in least square (LS) mean between each dose of sarilumab and placebo were derived. Testing was performed according to the hierarchical testing procedure (performed only when the previous endpoint was statistically significant).||-0.157|-0.312|<0.0001
70994679|NCT01061736|141498262|SUPERIORITY_OR_OTHER||LS mean difference|-0.258|||<|0.0001|TWO_SIDED|95.0|-0.336|-0.181||Threshold for significance = 0.025.|Mixed Models Analysis|||||-0.181|-0.336|<0.0001
71099601|NCT00066937|141708049|OTHER||||||<|0.05|||||||ANOVA|Repeated measures ANOVAs compared baseline scores to each period of follow-up (post-treatment, 3-months, 6 months)||||||<.05
71099602|NCT00066937|141708050|OTHER||||||<|0.05|||||||ANOVA|Repeated measures ANOVAs compared baseline scores to each period of follow-up (post-treatment, 3-months, 6 months)||||||<.05
71099603|NCT00066937|141708051|OTHER||||||<|0.05|||||||ANOVA|Repeated measures ANOVAs compared baseline scores to each period of follow-up (post-treatment, 3-months, 6 months)||||||<.05
71099604|NCT03072875|141708052|OTHER|Descriptive statistic.|||||||||||||||||Quantitative data (descriptive statistic) from the USAQ were used to determine feasibility. Specifically, we established an a priori mean score of 3.5 or greater on the USAQ to determine feasibility.|||
70994680|NCT01061736|141498263|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Threshold for significance = 0.025.|Rank ANCOVA|||Analysis was performed using two-sided rank-based ANCOVA model. Testing was performed according to the hierarchical testing procedure (performed only when the previous endpoints were statistically significant).||||<0.0001
71099605|NCT03478787|141708054|NON_INFERIORITY|Non-inferiority is met if the lower bound of the 96.25% confidence interval (CI) of adjusted treatment difference is above -12%.|Adjusted percentage difference|8.2|||||TWO_SIDED|96.25|-2.2|18.6|||||Across the strata, 96.25% confidence interval (CI) for adjusted difference was calculated according to the Cochran-Mantel-Haenszel test for the comparison of 2 treatment groups.|||18.6|-2.2|
70994681|NCT01061736|141498263|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Threshold for significance = 0.025.|Rank ANCOVA|||||||<0.0001
70994682|NCT01061736|141498264|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.661|||<|0.0001|TWO_SIDED|95.0|2.451|8.863||Threshold for significance = 0.025.|Cochran-Mantel-Haenszel|||Analysis was performed using two-sided Cochran-Mantel-Haenszel test. Pairwise comparisons of the response rates between each dose of sarilumab and placebo were derived. Testing was performed according to the hierarchical testing procedure (performed only when the previous endpoints were statistically significant).||8.863|2.451|<0.0001
70994683|NCT01061736|141498264|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.565|||<|0.0001|TWO_SIDED|95.0|2.946|10.515||Threshold for significance = 0.025.|Cochran-Mantel-Haenszel|||||10.515|2.946|<0.0001
70994684|NCT01093755|141498265|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the two treatment groups at 3 months||||0.30
70994685|NCT01093755|141498265|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the two treatment groups at 6 months||||0.52
70994686|NCT01093755|141498266|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the two treatment groups at 3 months||||0.70
70994687|NCT01093755|141498266|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the two treatment groups at 6 months||||0.64
70994688|NCT03115112|141498267|NON_INFERIORITY|The non-inferiority margin of 0.35% was determined based on a reference clinical trial that demonstrated the effectiveness of sitagliptin, 100 mg, compared to placebo on HbA1c reduction in subjects with type 2 DM. A margin of 0.35% was selected to be approximately half of sitagliptin effect and remained clinically meaningful.|Difference of LS Means|0.08|||||TWO_SIDED|95.0|-0.07|0.22|||||Mixed-effects repeated measures analysis includes region, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as fixed effect covariates.|||0.22|-0.07|
71099606|NCT03478787|141708055|SUPERIORITY||Adjusted percentage difference|29.8|||<|0.001|TWO_SIDED|95.0|20.8|38.8||Across the strata, p-value was calculated from the from the Cochran-Mantel-Haenszel test adjusted for strata.|Cochran-Mantel-Haenszel||Across the strata, 95% CI for adjusted difference was calculated according to the Cochran-Mantel-Haenszel test for the comparison of 2 treatment groups.|||38.8|20.8|< 0.001
71099607|NCT03478787|141708056|SUPERIORITY||Adjusted percentage difference|26.2|||<|0.001|TWO_SIDED|95.0|15.9|36.5||Across the strata, p-value was calculated from the from the Cochran-Mantel-Haenszel test adjusted for strata.|Cochran-Mantel-Haenszel||Across the strata, 95% CI for adjusted difference was calculated according to the Cochran-Mantel-Haenszel test for the comparison of 2 treatment groups.|||36.5|15.9|< 0.001
70994689|NCT03115112|141498268|SUPERIORITY||Difference of LS Means|-0.37||||0.0123|TWO_SIDED|95.0|-0.7|-0.05|||Mixed-effects repeated measures|Covariate includes region, treatment, visit, treatment-by-visit interaction and the baseline FPG value as a fixed effect covariate.||||-0.05|-0.70|0.0123
70994690|NCT03115112|141498269|SUPERIORITY||Difference of LS Means|-2.54|||<|0.0001|TWO_SIDED|95.0|-3.15|-1.92|||Mixed-effects repeated measures|Included region, treatment, visit, treatment-by-visit interaction and the baseline body weight value as fixed effect covariate.||||-1.92|-3.15|<0.0001
71099608|NCT03478787|141708057|SUPERIORITY||Adjusted percentage difference|29.8|||<|0.001|TWO_SIDED|95.0|20.9|38.8||Across the strata, p-value was calculated from the from the Cochran-Mantel-Haenszel test adjusted for strata.|Cochran-Mantel-Haenszel||Across the strata, 95% CI for adjusted difference was calculated according to the Cochran-Mantel-Haenszel test for the comparison of 2 treatment groups.|||38.8|20.9|< 0.001
71099609|NCT03478787|141708058|SUPERIORITY||Adjusted percentage difference|20.0|||<|0.001|TWO_SIDED|95.0|11.7|28.3||Across the strata, p-value was calculated from the from the Cochran-Mantel-Haenszel test adjusted for strata.|Cochran-Mantel-Haenszel||Across the strata, 95% CI for adjusted difference was calculated according to the Cochran-Mantel-Haenszel test for the comparison of 2 treatment groups.|||28.3|11.7|< 0.001
70994691|NCT03115112|141498270|SUPERIORITY||mixed-effects repeated measures|-2.33||||0.0276|TWO_SIDED|95.0|-4.7|0.05|||t-test, 1 sided|p value was presented based on one sided statistical tests using a 0.025 level of significance|Included region, treatment, visit, treatment-by-visit interaction and the baseline body weight value as fixed effect covariate.|||0.05|-4.70|0.0276
70994692|NCT03084718|141498328|SUPERIORITY||Mean Difference (Final Values)|0.044||||0.567|TWO_SIDED|95.0|-0.052|0.14|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.140|-0.052|0.567
70994693|NCT03084718|141498328|SUPERIORITY||Mean Difference (Final Values)|0.113||||0.015|TWO_SIDED|95.0|0.018|0.209|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||0.209|0.018|0.015
70994694|NCT03084718|141498328|SUPERIORITY||Mean Difference (Final Values)|0.093||||0.059|TWO_SIDED|95.0|-0.003|0.188|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||0.188|-0.003|0.059
70994695|NCT03084718|141498328|SUPERIORITY||Mean Difference (Final Values)|0.069||||0.09|TWO_SIDED|95.0|-0.011|0.15|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.150|-0.011|0.090
70994696|NCT03084718|141498328|SUPERIORITY||Mean Difference (Final Values)|0.049||||0.231|TWO_SIDED|95.0|-0.031|0.129|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.129|-0.031|0.231
71099610|NCT04679818|141708059|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.895|TWO_SIDED|99.0|-1.43|1.58|||Mixed Models Analysis|||||1.58|-1.43|0.895
71099611|NCT04679818|141708060|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.228|TWO_SIDED|99.0|-2.66|0.99|||Mixed Models Analysis|||||0.99|-2.66|0.228
71099612|NCT04679818|141708061|SUPERIORITY||Risk Ratio (RR)|0.81||||0.565|TWO_SIDED|95.0|0.4|1.65|||generalized linear mixed effects model|||||1.65|0.40|0.565
71099613|NCT04679818|141708062|SUPERIORITY||Risk Ratio (RR)|1.48||||0.379|TWO_SIDED|95.0|0.62|3.54|||Generalized linear mixed effects model|||||3.54|0.62|0.379
71099614|NCT04679818|141708063|SUPERIORITY||Median Difference (Final Values)|0.54||||0.039|TWO_SIDED|95.0|0.3|0.97|||Wilcoxon (Mann-Whitney)|||||0.97|0.30|0.039
71099615|NCT04679818|141708064|NON_INFERIORITY|We tested noninferiority of NOL to routine care on the Ramsey score using an a priori-defined noninferiority delta of 1.2 for the proportional odds ratio; NOL would be deemed noninferior if the upper confidence limit for the odds ratio was \<1.2.|Odds Ratio (OR)|0.8||||0.169|TWO_SIDED|95.0|0.35|1.82|||proportional odds model|||||1.82|0.35|0.169
71099616|NCT04679818|141708065|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.967|TWO_SIDED|95.0|0.63|1.63|||Cox proportional hazards regression|||||1.63|0.63|0.967
71099617|NCT01044693|141708072|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED||||||Mixed Models Analysis|||The main comparisons were between the active treatment groups versus placebo. We hypothesized that if NO-mediated vasodilation contributes to the BP-lowering effect of nebivolol then BP will be lowered by nebivolol and sildenafil, but not by metoprolol in autonomic failure patients.||||0.036
71099618|NCT01044693|141708072|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||The main comparisons were between the active treatment groups versus placebo. We hypothesized that if NO-mediated vasodilation contributes to the BP-lowering effect of nebivolol then BP will be lowered by nebivolol and sildenafil, but not by metoprolol in autonomic failure patients.||||<0.001
71099619|NCT01044693|141708072|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||The main comparisons were between the active treatment groups versus placebo. We hypothesized that if NO-mediated vasodilation contributes to the BP-lowering effect of nebivolol then BP will be lowered by nebivolol and sildenafil, but not by metoprolol in autonomic failure patients.||||>0.05
71099620|NCT01044693|141708073|SUPERIORITY_OR_OTHER|||||||0.607|TWO_SIDED||||||ANOVA|||The main comparisons were between the active treatment groups versus placebo.||||0.607
71099621|NCT01044693|141708074|SUPERIORITY_OR_OTHER|||||||0.597|TWO_SIDED||||||ANOVA|||The main comparisons were between the active treatment groups versus placebo.||||0.597
71099622|NCT01044693|141708075|SUPERIORITY_OR_OTHER|||||||0.996|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The main comparisons were between the negative chronotropic effect of nebivolol and metoprolol at the time when BP-lowering effects were maximal.||||0.996
71099623|NCT01316900|141708076|SUPERIORITY_OR_OTHER||Least squares mean difference|0.09|||<|0.001|TWO_SIDED|95.0|0.039|0.142|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus VI 25 µg.|||0.142|0.039|<0.001
70994697|NCT03084718|141498328|SUPERIORITY||Mean Difference (Final Values)|-0.021||||0.612|TWO_SIDED|95.0|-0.101|0.059|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.059|-0.101|0.612
70994698|NCT03084718|141498328|SUPERIORITY||Mean Difference (Final Values)|0.102||||0.011|TWO_SIDED|95.0|0.023|0.18|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||0.180|0.023|0.011
70994699|NCT03084718|141498329|SUPERIORITY||Mean Difference (Final Values)|0.018||||0.647|TWO_SIDED|95.0|-0.06|0.097|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.097|-0.060|0.647
71099624|NCT01316900|141708076|SUPERIORITY_OR_OTHER||Least squares mean difference|0.09|||<|0.001|TWO_SIDED|95.0|0.039|0.141||nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus Tio 18 µg.|||0.141|0.039|<0.001
71099625|NCT01316900|141708076|SUPERIORITY_OR_OTHER||Least squares mean difference|0.088|||<|0.001|TWO_SIDED|95.0|0.036|0.14|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 µg minus VI 25 µg.|||0.140|0.036|<0.001
71099626|NCT01316900|141708076|SUPERIORITY_OR_OTHER||Least squares mean difference|0.088|||<|0.001|TWO_SIDED|95.0|0.036|0.14|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 µg minus TIO 18 µg.|||0.140|0.036|<0.001
71099627|NCT00507507|141708124|SUPERIORITY_OR_OTHER|||||||0.016||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||The null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 400 copies/mL at Week 192 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference. The sample size provided at least 85% power to detect a difference of 30% between the groups, assuming response rates of 30% and 60% in the Tenofovir DF and FTC+Tenofovir DF groups, respectively.||||0.016
71099628|NCT00507507|141708125|SUPERIORITY_OR_OTHER|||||||0.05||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 48: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 400 copies/mL at Week 48 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.050
71099629|NCT00507507|141708125|SUPERIORITY_OR_OTHER|||||||0.009||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 96: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 400 copies/mL at Week 96 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.009
71099630|NCT00507507|141708125|SUPERIORITY_OR_OTHER|||||||0.03||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 144: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 400 copies/mL at Week 144 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.030
70994700|NCT03084718|141498329|SUPERIORITY||Mean Difference (Final Values)|0.118||||0.004|TWO_SIDED|95.0|0.039|0.196|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||0.196|0.039|0.004
70994701|NCT03084718|141498329|SUPERIORITY||Mean Difference (Final Values)|0.071||||0.076|TWO_SIDED|95.0|-0.008|0.149|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||0.149|-0.008|0.076
70994702|NCT03084718|141498329|SUPERIORITY||Mean Difference (Final Values)|0.099||||0.014|TWO_SIDED|95.0|0.02|0.179|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.179|0.020|0.014
70994703|NCT03084718|141498329|SUPERIORITY||Mean Difference (Final Values)|0.052||||0.192|TWO_SIDED|95.0|-0.026|0.131|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.131|-0.026|0.192
70994704|NCT03084718|141498329|SUPERIORITY||Mean Difference (Final Values)|-0.047||||0.244|TWO_SIDED|95.0|-0.126|0.032|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.032|-0.126|0.244
70994705|NCT03084718|141498329|SUPERIORITY||Mean Difference (Final Values)|0.074||||0.06|TWO_SIDED|95.0|-0.003|0.151|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||0.151|-0.003|0.060
70994706|NCT03084718|141498330|SUPERIORITY||Mean Difference (Final Values)|0.012||||0.78|TWO_SIDED|95.0|-0.074|0.098|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.098|-0.074|0.780
70994707|NCT03084718|141498330|SUPERIORITY||Mean Difference (Final Values)|0.076||||0.086|TWO_SIDED|95.0|-0.011|0.162|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||0.162|-0.011|0.086
70994708|NCT03084718|141498330|SUPERIORITY||Mean Difference (Final Values)|0.043||||0.324|TWO_SIDED|95.0|-0.043|0.129|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||0.129|-0.043|0.324
70994709|NCT03084718|141498330|SUPERIORITY||Mean Difference (Final Values)|0.063||||0.153|TWO_SIDED|95.0|-0.024|0.15|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.150|-0.024|0.153
70994710|NCT03084718|141498330|SUPERIORITY||Mean Difference (Final Values)|0.031||||0.482|TWO_SIDED|95.0|-0.055|0.117|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.117|-0.055|0.482
70994711|NCT03084718|141498330|SUPERIORITY||Mean Difference (Final Values)|-0.032||||0.463|TWO_SIDED|95.0|-0.119|0.054|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.054|-0.119|0.463
71040277|NCT00487695|141588888|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed-rank|||The number of biopsies showing neoplasia was determined for each procedure (confocal laser endomicroscopy, standard EGD). These were compared. This analysis looks at the patients referred for Barrett's surveillance EGD (no suspected neoplasia).||||1.0
71040278|NCT00487695|141588889|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed-rank|||The null hypothesis would be that CLE does not decrease the number of biopsies needed to make a diagnosis compared to standard endoscopy||||<0.0001
71040279|NCT04542694|141588892|SUPERIORITY||The difference in proportions|0.1313||||0.0372|TWO_SIDED|95.0|-0.0004|0.2367|||Chi-squared|||A comparative analysis of the rate of clinical status improvement by 2 or more categories. The difference in percentages between the AREPLIVIR arm and the standard therapy arm (pa-pb)||0.2367|-0.0004|0.0372
71040280|NCT04542694|141588893|SUPERIORITY||The difference in days|4.0|||<|0.0001|TWO_SIDED||||||Log Rank|||Comparative analysis of time to clinical status improvement by categorical ordinal clinical improvement scale between the AREPLIVIR arm and the standard therapy arm||||<0.0001
71099631|NCT00507507|141708126|SUPERIORITY_OR_OTHER|||||||0.703||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 48: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 169 copies/mL at Week 48 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.703
70994712|NCT03084718|141498330|SUPERIORITY||Mean Difference (Final Values)|0.032||||0.453|TWO_SIDED|95.0|-0.052|0.117|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||0.117|-0.052|0.453
70994713|NCT03084718|141498330|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.533|TWO_SIDED|95.0|-0.064|0.123|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.123|-0.064|0.533
71040281|NCT04542694|141588894|SUPERIORITY||The difference in percentages|22.5||||0.00016|TWO_SIDED||||||Chi-squared|||||||0.00016
71099632|NCT00507507|141708126|SUPERIORITY_OR_OTHER|||||||0.034||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 96: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 169 copies/mL at Week 96 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.034
71099633|NCT00507507|141708126|SUPERIORITY_OR_OTHER|||||||0.011||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 144: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 169 copies/mL at Week 144 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.011
71040282|NCT04542694|141588895|SUPERIORITY||Median Difference (Final Values)|1.55||||0.052|TWO_SIDED||||||Log Rank|||||||0.052
71040283|NCT04542694|141588896|SUPERIORITY|||||||0.1953|||||||Chi-squared|||||||0.1953
71040284|NCT04542694|141588897|SUPERIORITY|||||||0.4975|||||||Chi-squared|||||||0.4975
71040285|NCT01957150|141588909|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of 95 % confidence interval (CI) for the overall treatment difference change from Baseline between FF/VI and VI was greater than -1 % year|Percentage Change from Baseline|-0.46|||||TWO_SIDED|95.0|-0.97|0.06|||||Treatment comparison for overall weeks|||0.06|-0.97|
71040286|NCT01957150|141588910|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of 95% CI for the overall treatment difference change from Baseline between FF/VI and VI was greater than -1 % year|Percentage Change from Baseline|-0.47|||||TWO_SIDED|95.0|-1.17|0.24|||||Overall Weeks for Male|||0.24|-1.17|
71099634|NCT00507507|141708126|SUPERIORITY_OR_OTHER|||||||0.007||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 192: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 169 copies/mL at Week 192 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.007
71099635|NCT00507507|141708127|SUPERIORITY_OR_OTHER|||||||0.01||||||A Wilcoxon rank-sum (2-sided) test was used, with no adjustments for covariates.|Wilcoxon (Mann-Whitney)|||The null hypothesis was that there was no difference of change in HBV DNA from baseline between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.010
70994714|NCT03084718|141498330|SUPERIORITY||Mean Difference (Final Values)|0.105||||0.029|TWO_SIDED|95.0|0.011|0.199|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||0.199|0.011|0.029
70994715|NCT03084718|141498330|SUPERIORITY||Mean Difference (Final Values)|0.052||||0.274|TWO_SIDED|95.0|-0.041|0.146|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||0.146|-0.041|0.274
70994716|NCT03084718|141498330|SUPERIORITY||Mean Difference (Final Values)|0.075||||0.119|TWO_SIDED|95.0|-0.019|0.169|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.169|-0.019|0.119
70994717|NCT03084718|141498330|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.638|TWO_SIDED|95.0|-0.071|0.116|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.116|-0.071|0.638
70994718|NCT03084718|141498330|SUPERIORITY||Mean Difference (Final Values)|-0.052||||0.274|TWO_SIDED|95.0|-0.147|0.042|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.042|-0.147|0.274
70994719|NCT03084718|141498330|SUPERIORITY||Mean Difference (Final Values)|0.079||||0.092|TWO_SIDED|95.0|-0.013|0.171|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||0.171|-0.013|0.092
70994720|NCT03084718|141498331|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.053|TWO_SIDED|95.0|-0.31|0.0|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.00|-0.31|0.053
70994721|NCT03084718|141498331|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.001|TWO_SIDED|95.0|-0.42|-0.11|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.11|-0.42|0.001
70994722|NCT03084718|141498331|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.006|TWO_SIDED|95.0|-0.37|-0.06|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.06|-0.37|0.006
70994723|NCT03084718|141498331|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.176|TWO_SIDED|95.0|-0.26|0.05|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.05|-0.26|0.176
70994724|NCT03084718|141498331|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.423|TWO_SIDED|95.0|-0.22|0.09|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.09|-0.22|0.423
70994725|NCT03084718|141498331|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.574|TWO_SIDED|95.0|-0.11|0.2|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.20|-0.11|0.574
70994726|NCT03084718|141498331|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.011|TWO_SIDED|95.0|-0.35|-0.05|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||-0.05|-0.35|0.011
70994727|NCT03084718|141498331|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.215|TWO_SIDED|95.0|-0.27|0.06|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo"||0.06|-0.27|0.215
70994728|NCT03084718|141498331|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.07|TWO_SIDED|95.0|-0.32|0.01|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||0.01|-0.32|0.070
70994729|NCT03084718|141498331|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.005|TWO_SIDED|95.0|-0.4|-0.07|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.07|-0.40|0.005
70994730|NCT03084718|141498331|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.566|TWO_SIDED|95.0|-0.21|0.12|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.12|-0.21|0.566
70994731|NCT03084718|141498331|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.124|TWO_SIDED|95.0|-0.29|0.04|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.04|-0.29|0.124
70994732|NCT03084718|141498331|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.336|TWO_SIDED|95.0|-0.25|0.08|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.08|-0.25|0.336
70994733|NCT03084718|141498331|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.01|TWO_SIDED|95.0|-0.37|-0.05|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||-0.05|-0.37|0.010
70994734|NCT03084718|141498332|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.067|TWO_SIDED|95.0|-0.38|0.01|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.01|-0.38|0.067
70994735|NCT03084718|141498332|SUPERIORITY||Mean Difference (Final Values)|-0.34|||<|0.001|TWO_SIDED|95.0|-0.53|-0.14|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.14|-0.53|< 0.001
70994736|NCT03084718|141498332|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.038|TWO_SIDED|95.0|-0.4|-0.01|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.01|-0.40|0.038
71040287|NCT01957150|141588911|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of 95% CI for the overall treatment difference change from Baseline between FF/VI and VI was greater than -1 % year|Percentage Change from Baseline|-0.4|||||TWO_SIDED|95.0|-1.16|0.36|||||Overall Weeks for female|||0.36|-1.16|
71040288|NCT01957150|141588912|OTHER||Percentage Change from Baseline|-1.02|||||TWO_SIDED|95.0|-1.9|-0.13|||||Overall Weeks for Male|||-0.13|-1.90|
71040289|NCT01957150|141588913|OTHER||Percentage Change from Baseline|-0.05|||||TWO_SIDED|95.0|-0.87|0.78|||||Overall Weeks for female|||0.78|-0.87|
71040290|NCT01957150|141588914|OTHER||Percentage Change from Baseline|-0.51|||||TWO_SIDED|95.0|-1.11|0.1|||||Overall week|||0.10|-1.11|
71040291|NCT01207752|141588916|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55|TWO_SIDED||||||t-test, 2 sided|||||||0.550
71040292|NCT01632215|141588927|SUPERIORITY||Mean Difference (Net)|0.3|||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
71040293|NCT04010227|141588955|SUPERIORITY||partial correlation|0.08||||0.6|TWO_SIDED|95.0|-0.23|0.4||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. multiply imputed data were used in analyses.||||0.40|-0.23|0.60
71040294|NCT04010227|141588956|SUPERIORITY||partial correlation|0.02||||0.96|TWO_SIDED|95.0|-0.29|0.34||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.34|-0.29|0.96
71040295|NCT04010227|141588957|SUPERIORITY||partial correlation|0.06||||0.75|TWO_SIDED|95.0|-0.25|0.38||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.38|-0.25|0.75
71040296|NCT04010227|141588958|SUPERIORITY||partial correlation|0.09||||0.33|TWO_SIDED|95.0|-0.23|0.4||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 144. Multiply imputed data were used.||||0.40|-0.23|0.33
71099636|NCT00507507|141708128|SUPERIORITY_OR_OTHER|||||||0.019||||||A Wilcoxon rank-sum (2-sided) test was used, with no adjustments for covariates.|Wilcoxon (Mann-Whitney)|||The null hypothesis was that there was no difference of change in HBV DNA from baseline between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.019
71099637|NCT00507507|141708129|SUPERIORITY_OR_OTHER|||||||0.186||||||A Wilcoxon rank-sum (2-sided) test was used, with no adjustments for covariates.|Wilcoxon (Mann-Whitney)|||The null hypothesis was that there was no difference of change in HBV DNA from baseline between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.186
71099638|NCT00507507|141708130|SUPERIORITY_OR_OTHER|||||||0.07||||||A Wilcoxon rank-sum (2-sided) test was used, with no adjustments for covariates.|Wilcoxon (Mann-Whitney)|||The null hypothesis was that there was no difference of change in HBV DNA from baseline between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.070
70994737|NCT03084718|141498332|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.13|TWO_SIDED|95.0|-0.35|0.05|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.05|-0.35|0.130
71040297|NCT04010227|141588959|SUPERIORITY||partial correlation|0.03||||0.91|TWO_SIDED|95.0|-0.29|0.34||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 144. Multiply imputed data were used.||||0.34|-0.29|0.91
70994738|NCT03084718|141498332|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.811|TWO_SIDED|95.0|-0.22|0.17|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.17|-0.22|0.811
70994739|NCT03084718|141498332|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.202|TWO_SIDED|95.0|-0.07|0.33|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.33|-0.07|0.202
71099639|NCT00507507|141708131|SUPERIORITY_OR_OTHER|||||||0.467||||||A Fisher exact test with a 0.05 two-sided significance level was used, with no adjustments for covariates.|Fisher Exact|||Analysis at Week 48: the null hypothesis was that there was no difference in the proportion of subjects with normal ALT at Week 48 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.467
70994740|NCT03084718|141498332|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.044|TWO_SIDED|95.0|-0.39|-0.01|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||-0.01|-0.39|0.044
70994741|NCT03084718|141498332|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.283|TWO_SIDED|95.0|-0.37|0.11|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.11|-0.37|0.283
70994742|NCT03084718|141498332|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.003|TWO_SIDED|95.0|-0.6|-0.13|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.13|-0.60|0.003
71040298|NCT04010227|141588960|SUPERIORITY||partial correlation|0.06||||0.74|TWO_SIDED|95.0|-0.25|0.38||P-value for study group x time interaction for patient physical quality of life. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.38|-0.25|0.74
71040299|NCT04010227|141588960|SUPERIORITY||partial correlation|0.14||||0.24|TWO_SIDED|95.0|-0.18|0.45||P-value for study group x time interaction for patient psychological quality of life. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.45|-0.18|0.24
71040300|NCT04010227|141588960|SUPERIORITY||partial correlation|0.06||||0.78|TWO_SIDED|95.0|-0.26|0.37||P-value for study group x time interaction for patient existential quality of life. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.37|-0.26|0.78
71040301|NCT04010227|141588960|SUPERIORITY||partial correlation|0.13||||0.29|TWO_SIDED|95.0|-0.19|0.44||P-value for study group x time interaction for patient social quality of life. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.44|-0.19|0.29
71040302|NCT04010227|141588961|SUPERIORITY||partial correlation|0.03||||0.92|TWO_SIDED|95.0|-0.28|0.35||P-value for study group x time interaction for caregiver physical quality of life. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.35|-0.28|0.92
71040303|NCT04010227|141588961|SUPERIORITY||partial correlation|0.06||||0.79|TWO_SIDED|95.0|-0.26|0.37||P-value for study group x time interaction for caregiver psychological quality of life. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.37|-0.26|0.79
71040304|NCT04010227|141588962|SUPERIORITY||partial correlation|0.02||||0.94|TWO_SIDED|95.0|-0.3|0.34||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 144. Multiply imputed data were used.||||0.34|-0.30|0.94
71040305|NCT03922750|141588965|OTHER||Estimated mean treatment difference|1.01||||0.7542|TWO_SIDED|95.0|-5.33|7.35|||ANCOVA|||The response and change from baseline in response during last two weeks of treatment (week 15 and 16) were analysed using an analysis of covariance (ANCOVA) model with treatment, pre-trial insulin treatment and SGLT2i use as fixed factors, and baseline response as covariate. Missing endpoint values were imputed using multiple imputation based on own treatment arm with baseline response as a covariate. Each imputed dataset was analysed separately and estimates were combined using Rubin's rules.||7.35|-5.33|0.7542
71099640|NCT00507507|141708131|SUPERIORITY_OR_OTHER|||||||1||||||A Fisher exact test with a 0.05 two-sided significance level was used, with no adjustments for covariates.|Fisher Exact|||Analysis at Week 96: the null hypothesis was that there was no difference in the proportion of subjects with normal ALT at Week 96 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||1.000
71099641|NCT00507507|141708131|SUPERIORITY_OR_OTHER|||||||0.529||||||A Fisher exact test with a 0.05 two-sided significance level was used, with no adjustments for covariates.|Fisher Exact|||Analysis at Week 144: the null hypothesis was that there was no difference in the proportion of subjects with normal ALT at Week 144 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.529
71099642|NCT00507507|141708131|SUPERIORITY_OR_OTHER|||||||0.451||||||A Fisher exact test with a 0.05 two-sided significance level was used, with no adjustments for covariates.|Fisher Exact|||Analysis at Week 192: the null hypothesis was that there was no difference in the proportion of subjects with normal ALT at Week 192 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.451
71099643|NCT00507507|141708132|SUPERIORITY_OR_OTHER|||||||0.496||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 96: the null hypothesis was that there was no difference in the proportion of subjects with HBeAg loss between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.496
71099644|NCT00507507|141708132|SUPERIORITY_OR_OTHER|||||||0.119||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 144: the null hypothesis was that there was no difference in the proportion of subjects with HBeAg loss between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.119
71099645|NCT00507507|141708132|SUPERIORITY_OR_OTHER|||||||0.365||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 192: the null hypothesis was that there was no difference in the proportion of subjects with HBeAg loss between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.365
71099646|NCT00507507|141708133|SUPERIORITY_OR_OTHER|||||||0.496||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 96: the null hypothesis was that there was no difference in the proportion of subjects with seroconversion to anti-HBe between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.496
71099647|NCT00507507|141708133|SUPERIORITY_OR_OTHER|||||||0.119||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 144: the null hypothesis was that there was no difference in the proportion of subjects with seroconversion to anti-HBe between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.119
71099648|NCT00507507|141708133|SUPERIORITY_OR_OTHER|||||||0.244||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 192: the null hypothesis was that there was no difference in the proportion of subjects with seroconversion to anti-HBe between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.244
71099649|NCT01623154|141708141|NON_INFERIORITY_OR_EQUIVALENCE|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.|Slope|0.99|||||TWO_SIDED|95.0|0.987|0.993||95% confidence interval is used instead of p-value.|Deming Regression|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|95% confidence interval is used instead of p-value.|||0.993|0.987|
71099650|NCT01623154|141708141|NON_INFERIORITY_OR_EQUIVALENCE|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.|Intercept|-0.04|||||TWO_SIDED|95.0|-0.25|0.17|||Deming Regression|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|95% confidence interval is used instead of p-value.|||0.17|-0.25|
70923498|NCT03391466|141338662|SUPERIORITY|One-sided p-value based on log-rank test stratified by response to first-line therapy and second-line age-adjusted IPI as data collected on case report forms.|Hazard Ratio (HR)|0.726||||0.0168|TWO_SIDED|95.0|0.54|0.977||Stratified log-rank (randomization factor) p-value.|Log Rank|Stratified (randomization factor) log-rank test.|Hazard ratio (95% CI), stratified using randomization stratification factors.||The Rho family spending function with parameter (Rho = 6) was used to allocate alpha between the interim and primary OS analysis. Given that fewer than the anticipated 210 events were observed at the data cutoff date for the primary OS analysis (25 January 2023), the efficacy boundary for the primary OS analysis was recalculated using the Rho family spending function based on the actual observed event numbers (177 deaths) resulting in an efficacy boundary at 1-sided significance level of 0.0249.|0.977|0.540|0.0168
70923499|NCT03391466|141338663|SUPERIORITY|One-sided p-value based on log-rank test stratified by response to first-line therapy and second-line age-adjusted IPI as data collected on case report forms.|Hazard Ratio (HR)|0.736||||0.0695|TWO_SIDED|95.0|0.488|1.108||Stratified (randomization stratification factors) log-rank test.|Log Rank||Hazard ratio (95% CI), stratified using randomization stratification factors.|||1.108|0.488|0.0695
70923500|NCT03391466|141338664|SUPERIORITY||Hazard Ratio (HR)|0.376|||<|0.0001|TWO_SIDED|95.0|0.29|0.487||One-sided p-value based on log-rank test stratified by response to first-line therapy and second-line age-adjusted IPI as data collected on case report forms.|Log Rank|Stratified (randomization stratification factors) log-rank test.|Hazard ratio (95% CI), stratified using randomization stratification factors.|||0.487|0.290|<0.0001
70923501|NCT03391466|141338665|SUPERIORITY||Hazard Ratio (HR)|0.422|||||TWO_SIDED|95.0|0.327|0.545|||||Hazard ratio (95% CI), stratified using randomization stratification factors.|||0.545|0.327|
70923502|NCT03391466|141338666|SUPERIORITY||Hazard Ratio (HR)|0.506|||||TWO_SIDED|95.0|0.383|0.669|||||Hazard ratio (95% CI), stratified using randomization stratification factors.|||0.669|0.383|
70923503|NCT03391466|141338668|SUPERIORITY||Mixed Model with Repeated Measures|18.1|||<|0.0001|TWO_SIDED|95.0|12.3|23.9||False Discovery Rate Methodology|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 100.||23.9|12.3|<0.0001
70923504|NCT03391466|141338668|SUPERIORITY||Mixed Model with Repeated Measures|9.8||||0.0124|TWO_SIDED|95.0|2.6|17.0||False Discovery Rate Methodology|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 150.||17.0|2.6|0.0124
70923505|NCT03391466|141338668|SUPERIORITY||Mixed Model with Repeated Measures|4.4||||0.2655|TWO_SIDED|95.0|-3.3|12.0||False Discovery Rate Methodology|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Month 9.||12.0|-3.3|0.2655
70923506|NCT03391466|141338669|SUPERIORITY||Mixed Model with Repeated Measures|13.1|||<|0.0001|TWO_SIDED|95.0|8.0|18.2||False Discovery Rate Methodology.|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 100.||18.2|8.0|<0.0001
70923507|NCT03391466|141338669|SUPERIORITY||Mixed Model with Repeated Measures|5.1||||0.1253|TWO_SIDED|95.0|-0.9|11.0||False Discovery Rate Methodology.|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 150.||11.0|-0.9|0.1253
70923508|NCT03391466|141338670|SUPERIORITY||Mixed Model with Repeated Measures|0.081||||0.0112|TWO_SIDED|95.0|0.024|0.138||False Discovery Rate Methodology.|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 100.||0.138|0.024|0.0112
70923509|NCT03391466|141338670|SUPERIORITY||Mixed Model with Repeated Measures|0.028||||0.3703|TWO_SIDED|95.0|-0.034|0.091||False Discovery Rate Methodology.|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 150.||0.091|-0.034|0.3703
70923510|NCT03391466|141338671|SUPERIORITY||Mixed Model with Repeated Measures|13.7|||<|0.0001|TWO_SIDED|95.0|8.5|18.8||False Discovery Rate Methodology|Mixed Model with Repeated Measures|Mixed Model with Repeated Measures Differences in Change from Baseline.||Difference in mean change of scores from Baseline at Day 100.||18.8|8.5|<0.0001
70923511|NCT03391466|141338671|SUPERIORITY||Mixed Model with Repeated Measures|11.3||||0.0004|TWO_SIDED|95.0|5.4|17.1||False Discovery Rate Methodology|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 150.||17.1|5.4|0.0004
70923512|NCT03391466|141338671|SUPERIORITY||Mixed Model with Repeated Measures|3.8||||0.2549|TWO_SIDED|95.0|-2.3|10.0||False Discovery Rate Methodology.|Mixed Model with Repeated Measures|Mixed Model with Repeated Measures Differences in Change from Baseline.||Difference in mean change of scores from Baseline at Month 9.||10.0|-2.3|0.2549
70923513|NCT03655132|141338676|OTHER|Regression of baseline score on intrinsic motivation to use VACT-CP online program on actual VACT-CP use (i.e., number of modules completed.)|Pearson's correlation coefficient|0.12||||0.62|TWO_SIDED||||||Regression, Linear|||||||.62
70923514|NCT03655132|141338676|OTHER|Regression of baseline score on perceived ease of use of the VACT-CP online program on actual VACT-CP use (i.e., number of modules completed.)|Pearson's correlation coefficient|0.19||||0.45|TWO_SIDED||||||Regression, Linear|||||||.45
70923515|NCT03655132|141338676|OTHER|Regression of baseline score on perceived usefulness of the VACT-CP online program on actual VACT-CP use (i.e., number of modules completed.)|Pearson's correlation coefficient|0.02||||0.93|TWO_SIDED||||||Regression, Linear|||||||.93
70923516|NCT03655132|141338676|OTHER|Regression of post-intervention score of intrinsic motivation to use VACT-CP online program on actual VACT-CP use (i.e., number of modules completed.)|Pearson's correlation coefficient|0.51||||0.04|TWO_SIDED||||||Regression, Linear|||||||.04
70923517|NCT03655132|141338676|OTHER|Regression of post-intervention score of perceived ease of use of the VACT-CP online program on actual VACT-CP use (i.e., number of modules completed.)|Pearson's correlation coefficient|0.54||||0.03|TWO_SIDED||||||Regression, Linear|||||||.03
70923518|NCT03655132|141338676|OTHER|Regression of post-intervention score of perceived usefulness of VACT-CP online program on actual VACT-CP use (i.e., number of modules completed.)|Pearson's correlation coefficient|0.58||||0.01|TWO_SIDED||||||Regression, Linear|||||||.01
70923519|NCT03655132|141338677|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8) for waitlist control group participants only (n=22).|Median Difference (Net)|-5.0||||0.54|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.54
70923520|NCT03655132|141338677|OTHER||Median Difference (Net)|-1.5||||0.59|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8) for VACT-CP group.||||.59
70923521|NCT03655132|141338678|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|2.0||||0.78|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.78
71040306|NCT03922750|141588965|OTHER||Estimated mean treatment difference|7.88||||0.0107|TWO_SIDED|95.0|1.83|13.93|||ANCOVA|||The response and change from baseline in response during last two weeks of treatment (week 15 and 16) were analysed using an analysis of covariance (ANCOVA) model with treatment, pre-trial insulin treatment and SGLT2i use as fixed factors, and baseline response as covariate. Missing endpoint values were imputed using multiple imputation based on own treatment arm with baseline response as a covariate. Each imputed dataset was analysed separately and estimates were combined using Rubin's rules.||13.93|1.83|0.0107
71040307|NCT01841073|141588987|SUPERIORITY|||||||0.005||||||p-value was calculated, and is not attempting to indicate the threshold for statistical significance|ANCOVA|||||||0.005
71040308|NCT01841073|141588988|SUPERIORITY|||||||0.027|||||||ANCOVA|||||||0.027
71040309|NCT01841073|141588989|SUPERIORITY|||||||0.13|||||||ANCOVA|||||||0.13
71040310|NCT03174158|141588991|SUPERIORITY|||||||0.07||||||a priori p value threshold \< 0.05|Chi-squared|||||||0.07
71099651|NCT01623154|141708141|NON_INFERIORITY_OR_EQUIVALENCE|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.|Slope|0.99|||||TWO_SIDED|95.0|0.987|0.993|||Regression, Linear|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|95% confidence interval is used instead of p-value.|||0.993|0.987|
70994743|NCT03084718|141498332|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.027|TWO_SIDED|95.0|-0.5|-0.03|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.03|-0.50|0.027
70994744|NCT03084718|141498332|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.054|TWO_SIDED|95.0|-0.48|0.0|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.00|-0.48|0.054
70994745|NCT03084718|141498332|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.258|TWO_SIDED|95.0|-0.38|0.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.10|-0.38|0.258
70994746|NCT03084718|141498332|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.423|TWO_SIDED|95.0|-0.14|0.34|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.34|-0.14|0.423
70994747|NCT03084718|141498332|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.111|TWO_SIDED|95.0|-0.42|0.04|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||0.04|-0.42|0.111
70994748|NCT03084718|141498332|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.135|TWO_SIDED|95.0|-0.36|0.05|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.05|-0.36|0.135
70994749|NCT03084718|141498332|SUPERIORITY||Mean Difference (Final Values)|-0.35|||<|0.001|TWO_SIDED|95.0|-0.56|-0.14|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.14|-0.56|< 0.001
71040311|NCT03174158|141588991|SUPERIORITY|||||||0.18|||||||Chi-squared|a priori threshold p\<0.05||||||0.18
71040312|NCT03174158|141588991|SUPERIORITY|||||||0.21||||||a priori threshold p\<0.05|Chi-squared|||||||0.21
71040313|NCT01321177|141589040|SUPERIORITY|||||||0.0145|||||||Regression, Linear|||||||0.0145
71040314|NCT03702816|141589078|OTHER|Linear Regression||||||0.6|||||||Regression, Linear|F=0.308||Linear Regression of Memory Composite Scores and Frontal GE180 SUVR in Control Subjects||||0.60
71040315|NCT03702816|141589078|OTHER|Linear Regression||||||0.56|||||||Regression, Linear|F=0.367||Linear Regression of Executive Function Composite Scores and Frontal GE180 SUVR in Control Subjects||||0.56
70994750|NCT03084718|141498332|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.024|TWO_SIDED|95.0|-0.44|-0.03|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.03|-0.44|0.024
70994751|NCT03084718|141498332|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.067|TWO_SIDED|95.0|-0.4|0.01|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.01|-0.40|0.067
70994752|NCT03084718|141498332|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.444|TWO_SIDED|95.0|-0.29|0.13|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.13|-0.29|0.444
70994753|NCT03084718|141498332|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.285|TWO_SIDED|95.0|-0.09|0.32|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.32|-0.09|0.285
71040316|NCT03702816|141589078|OTHER|Linear regression||||||0.44|||||||Regression, Linear|||Linear Regression of Speed Composite Scores and Frontal GE180 SUVR in Control Subjects||||0.44
71040317|NCT03702816|141589078|OTHER|Linear Regression||||||0.15|||||||Regression, Linear|F=2.55||Linear Regression of Language Composite Scores and Frontal GE180 SUVR in Control Subjects||||0.15
71040318|NCT03702816|141589078|OTHER|Linear Regression||||||0.39|||||||Regression, Linear|F=0.947||Linear Regression of Memory Composite Scores and Frontal GE180 SUVR in MCI Subjects||||0.39
71040319|NCT03702816|141589078|OTHER|Linear Regression||||||0.95|||||||Regression, Linear|F=0.004||Linear Regression of Executive Function Composite Scores and Frontal GE180 SUVR in MCI Subjects||||0.95
71040320|NCT03702816|141589078|OTHER|Linear Regulation||||||0.53|||||||Regression, Linear|F=0.483||Linear Regression of Speed Composite Scores and Frontal GE180 SUVR in MCI Subjects||||0.53
71040321|NCT03702816|141589078|OTHER|Linear Regression||||||0.19|||||||Regression, Linear|F=2.543||Linear Regression of Language Composite Scores and Frontal GE180 SUVR in MCI Subjects||||0.19
71040322|NCT03702816|141589078|OTHER|Linear Regression||||||0.32|||||||Regression, Linear|F=3.430||Linear Regression of Memory Composite Scores and Frontal GE180 SUVR in AD Subjects||||0.32
70994754|NCT03084718|141498332|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.06|TWO_SIDED|95.0|-0.4|0.01|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||0.01|-0.40|0.060
70994755|NCT03084718|141498333|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.115|TWO_SIDED|95.0|-1.1|10.0|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||10.0|-1.1|0.115
71040323|NCT03702816|141589078|OTHER|Linear Regression||||||0.11|||||||Regression, Linear|F=32.844||Linear Regression of Executive Function Composite Scores and Frontal GE180 SUVR in AD Subjects||||0.11
71040324|NCT03702816|141589078|OTHER|Linear Regression||||||0.31|||||||Regression, Linear|F=3.559||Linear Regression of Speed Composite Scores and Frontal GE180 SUVR in AD Subjects||||0.31
71040325|NCT03702816|141589078|OTHER|Linear Regression||||||0.005|||||||Regression, Linear|F=14362.699||Linear Regression of Language Composite Scores and Frontal GE180 SUVR in AD Subjects||||0.005
71099652|NCT01623154|141708141|NON_INFERIORITY_OR_EQUIVALENCE|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.|Intercept|-0.03|||||TWO_SIDED|95.0|-0.24|0.18|||Regression, Linear|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|95% confidence interval is used instead of p-value.|||0.18|-0.24|
71099653|NCT01623154|141708141|NON_INFERIORITY_OR_EQUIVALENCE|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.|Slope|0.995|||||TWO_SIDED|95.0|0.99|1.0|||Passing-Bablock|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|95% confidence interval is used instead of p-value.|||1.000|0.990|
71040326|NCT03702816|141589078|OTHER|Linear Regression||||||0.84|||||||Regression, Linear|F=0.056||Linear Regression of Memory Composite Scores and Frontal GE180 SUVR in PD Subjects||||0.84
71040327|NCT03702816|141589078|OTHER|Linear Regression||||||0.94|||||||Regression, Linear|F=0.008||Linear Regression of Executive Function Composite Scores and Frontal GE180 SUVR in PD Subjects||||0.94
71040328|NCT03702816|141589078|OTHER|Linear Regression||||||0.29|||||||Regression, Linear|F=2.01||Linear Regression of Speed Composite Scores and Frontal GE180 SUVR in PD Subjects||||0.29
71040329|NCT03702816|141589078|OTHER|Linear Regression||||||0.72|||||||Regression, Linear|F=0.173||Linear Regression of Language Composite Scores and Frontal GE180 SUVR in PD Subjects||||0.72
71099654|NCT01623154|141708141|NON_INFERIORITY_OR_EQUIVALENCE|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|Intercept|-0.04|||||TWO_SIDED|95.0|-0.3|0.01|||Passing-Bablok|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|95% confidence interval is used instead of p-value.|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.||0.01|-0.30|
71099655|NCT01623154|141708141|NON_INFERIORITY_OR_EQUIVALENCE|Described previously|Relative Sensitivity, %|100.0|||||TWO_SIDED|95.0|85.8|100.0|||||95% confidence interval is used instead of p-value.|Comparison of UHR Values obtained by UBit-IR300 and POCone were used to identify participants' H.pylori infection status. Participants with UHR value ≥ 10.0μg/min were considered positive for H.Pylori.||100|85.8|
71099656|NCT01623154|141708141|NON_INFERIORITY_OR_EQUIVALENCE|Provided previously|Relative Specificity, %|100.0|||||TWO_SIDED|95.0|94.9|100.0|||||95% confidence interval is used instead of p-value.|||100|94.9|
71099657|NCT00954538|141708148|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
70994756|NCT03084718|141498333|SUPERIORITY||Mean Difference (Final Values)|7.6||||0.008|TWO_SIDED|95.0|2.0|13.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||13.1|2.0|0.008
70994757|NCT03084718|141498333|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.099|TWO_SIDED|95.0|-0.9|10.2|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||10.2|-0.9|0.099
70994758|NCT03084718|141498333|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.275|TWO_SIDED|95.0|-2.5|8.8|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||8.8|-2.5|0.275
71040330|NCT03702816|141589079|OTHER|Linear Regression||||||0.54|||||||Regression, Linear|F=0.424||Linear Regression of Memory Composite Scores and Cingulate GE180 SUVR in Control Subjects||||0.54
71040331|NCT03702816|141589079|OTHER|Linear Regression||||||0.53|||||||Regression, Linear|F=0.447||Linear Regression of Executive Function Composite Scores and Cingulate GE180 SUVR in Control Subjects||||0.53
71040332|NCT03702816|141589079|OTHER|Linear Regression||||||0.23|||||||Regression, Linear|F=1.773||Linear Regression of Speed Composite Scores and Cingulate GE180 SUVR in Control Subjects||||0.23
71040333|NCT03702816|141589079|OTHER|Linear Regression||||||0.01|||||||Regression, Linear|F=3.615||Linear Regression of Language Composite Scores and Cingulate GE180 SUVR in Control Subjects||||0.01
71099658|NCT00954538|141708149|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12|||||TWO_SIDED|90.0|-0.04|0.27|||Linear Fixed Effects Model||Difference = AD group value - HE group value|A 90% confidence interval was calculated for the group difference (AD - HE) using the model results. As prespecified by the analysis plan, if the lower bound of the 90% confidence interval is above 0, then the hypothesis that \[18F\]MK-3328 can discriminate between AD patients and cognitively normal elderly controls as measured by regional tracer uptake following single IV doses of \[18F\]MK-3328 is supported.||0.27|-0.04|
70994759|NCT03084718|141498333|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.943|TWO_SIDED|95.0|-5.4|5.8|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||5.8|-5.4|0.943
70994760|NCT03084718|141498333|SUPERIORITY||Mean Difference (Final Values)|-2.9||||0.308|TWO_SIDED|95.0|-8.6|2.7|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||2.7|-8.6|0.308
70994761|NCT03084718|141498333|SUPERIORITY||Mean Difference (Final Values)|6.3||||0.024|TWO_SIDED|95.0|0.8|11.7|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||11.7|0.8|0.024
70994762|NCT03084718|141498333|SUPERIORITY||Mean Difference (Final Values)|4.8||||0.129|TWO_SIDED|95.0|-1.4|11.0|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||11.0|-1.4|0.129
70994763|NCT03084718|141498333|SUPERIORITY||Mean Difference (Final Values)|9.0||||0.004|TWO_SIDED|95.0|2.8|15.2|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||15.2|2.8|0.004
70994764|NCT03084718|141498333|SUPERIORITY||Mean Difference (Final Values)|5.9||||0.061|TWO_SIDED|95.0|-0.3|12.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||12.1|-0.3|0.061
70994765|NCT03084718|141498333|SUPERIORITY||Mean Difference (Final Values)|4.3||||0.18|TWO_SIDED|95.0|-2.0|10.5|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||10.5|-2.0|0.180
70994766|NCT03084718|141498333|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.721|TWO_SIDED|95.0|-5.1|7.4|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||7.4|-5.1|0.721
70994767|NCT03084718|141498333|SUPERIORITY||Mean Difference (Final Values)|-3.1||||0.328|TWO_SIDED|95.0|-9.4|3.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||3.1|-9.4|0.328
70994768|NCT03084718|141498333|SUPERIORITY||Mean Difference (Final Values)|7.1||||0.022|TWO_SIDED|95.0|1.0|13.2|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||13.2|1.0|0.022
70994769|NCT03084718|141498333|SUPERIORITY||Mean Difference (Final Values)|4.6||||0.101|TWO_SIDED|95.0|-0.9|10.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||10.1|-0.9|0.101
70994770|NCT03084718|141498333|SUPERIORITY||Mean Difference (Final Values)|8.3||||0.003|TWO_SIDED|95.0|2.8|13.9|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||13.9|2.8|0.003
70994771|NCT03084718|141498333|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.061|TWO_SIDED|95.0|-0.2|10.8|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||10.8|-0.2|0.061
70994772|NCT03084718|141498333|SUPERIORITY||Mean Difference (Final Values)|3.7||||0.196|TWO_SIDED|95.0|-1.9|9.3|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||9.3|-1.9|0.196
70994773|NCT03084718|141498333|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.814|TWO_SIDED|95.0|-4.9|6.3|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||6.3|-4.9|0.814
70994774|NCT03084718|141498333|SUPERIORITY||Mean Difference (Final Values)|-3.0||||0.291|TWO_SIDED|95.0|-8.6|2.6|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||2.6|-8.6|0.291
70994775|NCT03084718|141498333|SUPERIORITY||Mean Difference (Final Values)|6.7||||0.016|TWO_SIDED|95.0|1.3|12.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||12.1|1.3|0.016
70994776|NCT03084718|141498334|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
70994777|NCT03084718|141498334|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
70994778|NCT03084718|141498334|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
70994779|NCT03084718|141498334|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.913|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.1|-0.1|0.913
70994780|NCT03084718|141498334|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.871|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.1|-0.1|0.871
70994781|NCT03084718|141498334|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.958|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.1|-0.1|0.958
70994782|NCT03084718|141498334|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
70994783|NCT03084718|141498334|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.01|TWO_SIDED|95.0|-0.2|0.0|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||-0.0|-0.2|0.010
70994784|NCT03084718|141498334|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.011|TWO_SIDED|95.0|-0.2|0.0|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.0|-0.2|0.011
70994785|NCT03084718|141498334|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.002|TWO_SIDED|95.0|-0.2|0.0|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.0|-0.2|0.002
70994786|NCT03084718|141498334|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.996|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.1|-0.1|0.996
70994787|NCT03084718|141498334|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.632|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.1|-0.1|0.632
70994788|NCT03084718|141498334|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.63|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.1|-0.1|0.630
70994789|NCT03084718|141498334|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
70994790|NCT03084718|141498334|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.002|TWO_SIDED|95.0|-0.2|0.0|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||-0.0|-0.2|0.002
70994791|NCT03084718|141498334|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.001|TWO_SIDED|95.0|-0.2|0.0|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.0|-0.2|0.001
70994792|NCT03084718|141498334|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
70994793|NCT03084718|141498334|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.96|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.1|-0.1|0.960
70994794|NCT03084718|141498334|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.725|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.1|-0.1|0.725
70994795|NCT03084718|141498334|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.764|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.1|-0.1|0.764
70994796|NCT03084718|141498334|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
70994797|NCT03084718|141498335|SUPERIORITY||Mean Difference (Final Values)|2.9||||0.316|TWO_SIDED|95.0|-2.8|8.7|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||8.7|-2.8|0.316
70994798|NCT03084718|141498335|SUPERIORITY||Mean Difference (Final Values)|4.9||||0.097|TWO_SIDED|95.0|-0.9|10.7|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||10.7|-0.9|0.097
70994799|NCT03084718|141498335|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.128|TWO_SIDED|95.0|-1.3|10.2|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||10.2|-1.3|0.128
70994800|NCT03084718|141498335|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.511|TWO_SIDED|95.0|-3.9|7.8|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||7.8|-3.9|0.511
70994801|NCT03084718|141498335|SUPERIORITY||Mean Difference (Final Values)|1.5||||0.61|TWO_SIDED|95.0|-4.3|7.3|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||7.3|-4.3|0.610
70994802|NCT03084718|141498335|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.882|TWO_SIDED|95.0|-6.3|5.4|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||5.4|-6.3|0.882
71040334|NCT03702816|141589079|OTHER|Linear Regression||||||0.039|||||||Regression, Linear|F=9.204||Linear Regression of Memory Composite Scores and Cingulate GE180 SUVR in MCI Subjects||||0.039
71040335|NCT03702816|141589079|OTHER|Linear Regression||||||0.33|||||||Regression, Linear|F=1.209||Linear Regression of Executive Function Composite Scores and Cingulate GE180 SUVR in MCI Subjects||||0.33
71040336|NCT03702816|141589079|OTHER|Linear Regression||||||0.07|||||||Regression, Linear|F=5.801||Linear Regression of Speed Composite Scores and Cingulate GE180 SUVR in MCI Subjects||||0.07
71040337|NCT03702816|141589079|OTHER|Linear Regression||||||0.03|||||||Regression, Linear|F=10.374||Linear Regression of Language Composite Scores and Cingulate GE180 SUVR in MCI Subjects||||0.03
71040338|NCT03702816|141589079|OTHER|Linear Regression||||||0.27|||||||Regression, Linear|F=5.024||Linear Regression of Memory Composite Scores and Cingulate GE180 SUVR in AD Subjects||||0.27
71040339|NCT03702816|141589079|OTHER|Linear Regression||||||0.16|||||||Regression, Linear|F=15.568||Linear Regression of Executive Function Composite Scores and Cingulate GE180 SUVR in AD Subjects||||0.16
71040340|NCT03702816|141589079|OTHER|Linear Regression||||||0.262|||||||Regression, Linear|F=5.238||Linear Regression of Speed Composite Scores and Cingulate GE180 SUVR in AD Subjects||||0.262
71040341|NCT03702816|141589079|OTHER|Linear Regression||||||0.043|||||||Regression, Linear|F=221.308||Linear Regression of Language Composite Scores and Cingulate GE180 SUVR in AD Subjects||||0.043
71040342|NCT03702816|141589079|OTHER|Linear Regression||||||0.26|||||||Regression, Linear|F=2.430||Linear Regression of Memory Composite Scores and Cingulate GE180 SUVR in PD Subjects||||0.26
71040343|NCT03702816|141589079|OTHER|Linear Regression||||||0.38|||||||Regression, Linear|F=1.269||Linear Regression of Executive Function Composite Scores and Cingulate GE180 SUVR in PD Subjects||||0.38
71099659|NCT03061214|141708179|NON_INFERIORITY|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated difference in HbA1c between semaglutide and sitagliptin was less than 0.3%.|Treatment difference|-0.85|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.7|||Mixed Models Analysis|||The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and region China/Other as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution.||-0.70|-1.00|<.0001
71099660|NCT03061214|141708179|NON_INFERIORITY|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated difference in HbA1c between semaglutide and sitagliptin was less than 0.3%.|Treatment difference|-0.51|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.36|||Mixed Models Analysis|||The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and region China/Other as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution.||-0.36|-0.66|<.0001
71099661|NCT03061214|141708179|SUPERIORITY|Superiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated difference in HbA1c between semaglutide and sitagliptin was below 0%.|Treatment difference|-0.85|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.7|||Mixed Models Analysis|||The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and region China/Other as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution.||-0.70|-1.00|<.0001
71099662|NCT03061214|141708179|SUPERIORITY|Superiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated difference in HbA1c between semaglutide and sitagliptin was below 0%.|Treatment difference|-0.51|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.36|||Mixed Models Analysis|||The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and region China/Other as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution.||-0.36|-0.66|<.0001
71099663|NCT00600704|141708253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.379|STANDARD_DEVIATION|0.096|<|0.05|TWO_SIDED|95.0|0.189|0.569|||t-test, 2 sided|||Sample size calculation was based on a two-sided alpha error of .05 and 80% power. After applying the protocol in two equal groups of 10 patients, the analysis showed that the study requires 60 patients per group. However, we decided to enroll up to 100 patients per group to allow for patient attrition or missing data, and also in order to look for differences with regards to transfusion between patient subgroups.||0.569|0.189|<0.05
71099664|NCT00600704|141708253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.797|STANDARD_ERROR_OF_MEAN|0.168|<|0.05|TWO_SIDED|95.0|0.465|1.129|||Regression, Linear||The mean difference between groups B and A is adjusted for age, gender, BMI and preoperative HCT, while BSA, weight, height, postoperative HCT were not included in the final model to avoid collinearity.|Null hypothesis :restrictive fluid protocol does not have any effect concerning the mean number of PRC units transfused.||1.129|0.465|<0.05
71099665|NCT00215553|141708299|SUPERIORITY_OR_OTHER|||||||0.794||95.0|||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference between treatment groups||||0.794
71099666|NCT00215553|141708299|SUPERIORITY_OR_OTHER|||||||0.236||95.0|||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference between treatment groups||||0.236
71099667|NCT00215553|141708299|SUPERIORITY_OR_OTHER|||||||0.396||95.0|||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference between treatment groups||||0.396
71099668|NCT00215553|141708300|SUPERIORITY_OR_OTHER|||||||0.346||95.0|||||Cochran-Mantel-Haenszel|||||||0.346
71099669|NCT00215553|141708300|SUPERIORITY_OR_OTHER|||||||0.286||95.0|||||Cochran-Mantel-Haenszel|||||||0.286
71099670|NCT00215553|141708300|SUPERIORITY_OR_OTHER|||||||0.964||95.0|||||Cochran-Mantel-Haenszel|||||||0.964
71099671|NCT00215553|141708301|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||ANOVA|ANOVA on ranks||||||0.028
71099672|NCT00215553|141708301|SUPERIORITY_OR_OTHER|||||||0.147||95.0|||||ANOVA|ANOVA on ranks||||||0.147
71099673|NCT00215553|141708301|SUPERIORITY_OR_OTHER|||||||0.293||95.0|||||ANOVA|ANOVA on ranks||||||0.293
71099674|NCT00159874|141708352|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.02|STANDARD_ERROR_OF_MEAN|6.1||0.253|TWO_SIDED|95.0|-19.13|5.09|||ANCOVA||Least square mean difference of -7.02 was calculated as ' Sildenafil Medium Dose - Low Dose'|Analyses were performed using analysis of covariance with etiology, weight, day of assessment and baseline peak VO2 as the covariates.||5.09|-19.13|0.253
71099675|NCT00159874|141708352|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.84|STANDARD_ERROR_OF_MEAN|5.92||0.1|TWO_SIDED|95.0|-21.6|1.93|||ANCOVA||Least square mean difference of -9.84 was calculated as ' Sildenafil High Dose - Low Dose'|Analyses were performed using analysis of covariance with etiology, weight, day of assessment and baseline peak VO2 as the covariates.||1.93|-21.60|0.100
71099676|NCT00159874|141708352|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.82|STANDARD_ERROR_OF_MEAN|6.01||0.64|TWO_SIDED|95.0|-14.75|9.11|||ANCOVA||Least square mean difference of -2.82 was calculated as ' Sildenafil High Dose - Medium Dose'|Analyses were performed using analysis of covariance with etiology, weight, day of assessment and baseline peak VO2 as the covariates.||9.11|-14.75|0.640
71099677|NCT04019704|141708377|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||0.002
71099678|NCT02739828|141708434|SUPERIORITY|||||||0.0001|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0001
71099679|NCT02739828|141708435|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||< 0.0001
70994803|NCT03084718|141498335|SUPERIORITY||Mean Difference (Final Values)|7.2||||0.013|TWO_SIDED|95.0|1.5|12.9|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||12.9|1.5|0.013
70994804|NCT03084718|141498335|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.219|TWO_SIDED|95.0|-2.8|12.2|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||12.2|-2.8|0.219
71099680|NCT02739828|141708436|SUPERIORITY|||||||0.0004|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0004
71099681|NCT02739828|141708437|SUPERIORITY|||||||0.0005|||||||paired t-test|||Skin pain at its worst. Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0005
70994805|NCT03084718|141498335|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.166|TWO_SIDED|95.0|-2.2|12.8|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||12.8|-2.2|0.166
70994806|NCT03084718|141498335|SUPERIORITY||Mean Difference (Final Values)|5.5||||0.151|TWO_SIDED|95.0|-2.0|12.9|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||12.9|-2.0|0.151
70994807|NCT03084718|141498335|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.871|TWO_SIDED|95.0|-6.9|8.2|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||8.2|-6.9|0.871
70994808|NCT03084718|141498335|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.837|TWO_SIDED|95.0|-6.8|8.3|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||8.3|-6.8|0.837
70994809|NCT03084718|141498335|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.966|TWO_SIDED|95.0|-7.4|7.7|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||7.7|-7.4|0.966
70994810|NCT03084718|141498335|SUPERIORITY||Mean Difference (Final Values)|9.5||||0.012|TWO_SIDED|95.0|2.1|16.9|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||16.9|2.1|0.012
70994811|NCT03084718|141498335|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.233|TWO_SIDED|95.0|-2.5|10.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||10.1|-2.5|0.233
70994812|NCT03084718|141498335|SUPERIORITY||Mean Difference (Final Values)|5.1||||0.113|TWO_SIDED|95.0|-1.2|11.4|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||11.4|-1.2|0.113
70994813|NCT03084718|141498335|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.12|TWO_SIDED|95.0|-1.3|11.2|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||11.2|-1.3|0.120
70994814|NCT03084718|141498335|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.691|TWO_SIDED|95.0|-5.1|7.6|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||7.6|-5.1|0.691
70994815|NCT03084718|141498335|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.722|TWO_SIDED|95.0|-5.2|7.5|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||7.5|-5.2|0.722
71099682|NCT02739828|141708437|SUPERIORITY|||||||0.0006|||||||paired t-test|||Skin pain on average. Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0006
71099683|NCT02739828|141708438|SUPERIORITY|||||||0.0004|||||||paired t-test|||Skin pain at its worst. Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0004
70994816|NCT03084718|141498335|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.966|TWO_SIDED|95.0|-6.5|6.2|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||6.2|-6.5|0.966
70994817|NCT03084718|141498335|SUPERIORITY||Mean Difference (Final Values)|8.3||||0.008|TWO_SIDED|95.0|2.2|14.5|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||14.5|2.2|0.008
70994818|NCT03084718|141498336|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.426|TWO_SIDED|95.0|-3.4|7.9|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||7.9|-3.4|0.426
70994819|NCT03084718|141498336|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.055|TWO_SIDED|95.0|-0.1|11.2|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||11.2|-0.1|0.055
70994820|NCT03084718|141498336|SUPERIORITY||Mean Difference (Final Values)|5.4||||0.059|TWO_SIDED|95.0|-0.2|11.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||11.1|-0.2|0.059
70994821|NCT03084718|141498336|SUPERIORITY||Mean Difference (Final Values)|3.3||||0.263|TWO_SIDED|95.0|-2.5|9.0|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||9.0|-2.5|0.263
70994822|NCT03084718|141498336|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.28|TWO_SIDED|95.0|-2.6|8.8|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||8.8|-2.6|0.280
70994823|NCT03084718|141498336|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.965|TWO_SIDED|95.0|-5.9|5.6|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||5.6|-5.9|0.965
70994824|NCT03084718|141498336|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.007|TWO_SIDED|95.0|2.2|13.3|||Mixed Models Analysis|||"Inter-visit period 1~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||13.3|2.2|0.007
70994825|NCT03084718|141498336|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.308|TWO_SIDED|95.0|-3.5|11.2|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||11.2|-3.5|0.308
70994826|NCT03084718|141498336|SUPERIORITY||Mean Difference (Final Values)|5.8||||0.124|TWO_SIDED|95.0|-1.6|13.2|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||13.2|-1.6|0.124
70994827|NCT03084718|141498336|SUPERIORITY||Mean Difference (Final Values)|7.0||||0.063|TWO_SIDED|95.0|-0.4|14.3|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||14.3|-0.4|0.063
70994828|NCT03084718|141498336|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.602|TWO_SIDED|95.0|-5.5|9.4|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||9.4|-5.5|0.602
70994829|NCT03084718|141498336|SUPERIORITY||Mean Difference (Final Values)|3.2||||0.402|TWO_SIDED|95.0|-4.3|10.6|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||10.6|-4.3|0.402
70994830|NCT03084718|141498336|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.753|TWO_SIDED|95.0|-6.3|8.6|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||8.6|-6.3|0.753
70994831|NCT03084718|141498336|SUPERIORITY||Mean Difference (Final Values)|10.2||||0.006|TWO_SIDED|95.0|2.9|17.4|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||17.4|2.9|0.006
70994832|NCT03084718|141498336|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.331|TWO_SIDED|95.0|-3.1|9.2|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||9.2|-3.1|0.331
70994833|NCT03084718|141498336|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.073|TWO_SIDED|95.0|-0.5|11.9|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||11.9|-0.5|0.073
71040344|NCT03702816|141589079|OTHER|Linear Regression||||||0.07|||||||Regression, Linear|F=13.164||Linear Regression of Speed Composite Scores and Cingulate GE180 SUVR in PD Subjects||||0.07
71040345|NCT03702816|141589079|OTHER|Linear Regression||||||0.37|||||||Regression, Linear|F=1.312||Linear Regression of Language Composite Scores and Cingulate GE180 SUVR in PD Subjects||||0.37
71040346|NCT03702816|141589080|OTHER|Linear Regression||||||0.64|||||||Regression, Linear|F=0.233||Linear Regression of Memory Composite Scores and Parietal GE180 SUVR in Control Subjects||||0.64
71040347|NCT03702816|141589080|OTHER|Linear Regression||||||0.92|||||||Regression, Linear|F=0.011||Linear Regression of Executive Function Composite Scores and Parietal GE180 SUVR in Control Subjects||||0.92
71040348|NCT03702816|141589080|OTHER|Linear Regression||||||0.22|||||||Regression, Linear|F=1.790||Linear Regression of Speed Composite Scores and Parietal GE180 SUVR in Control Subjects||||0.22
71040349|NCT03702816|141589080|OTHER|Linear Regression||||||0.42|||||||Regression, Linear|F=0.720||Linear Regression of Language Composite Scores and Parietal GE180 SUVR in Control Subjects||||0.42
71040350|NCT03702816|141589080|OTHER|Linear Regression||||||0.61|||||||Regression, Linear|F=0.305||Linear Regression of Memory Composite Scores and Parietal GE180 SUVR in MCI Subjects||||0.61
71040351|NCT03702816|141589080|OTHER|Linear Regression||||||0.95|||||||Regression, Linear|F=0.005||Linear Regression of Executive Function Composite Scores and Parietal GE180 SUVR in MCI Subjects||||0.95
71040352|NCT03702816|141589080|OTHER|Linear Regression||||||0.55|||||||Regression, Linear|F=0.435||Linear Regression of Speed Composite Scores and Parietal GE180 SUVR in MCI Subjects||||0.55
71040353|NCT03702816|141589080|OTHER|Linear Regression||||||0.43|||||||Regression, Linear|F=0.787||Linear Regression of Language Composite Scores and Parietal GE180 SUVR in MCI Subjects||||0.43
71040354|NCT03702816|141589080|OTHER|Linear Regression||||||0.036|||||||Regression, Linear|F=316.379||Linear Regression of Memory Composite Scores and Parietal GE180 SUVR in AD Subjects||||0.036
70994834|NCT03084718|141498336|SUPERIORITY||Mean Difference (Final Values)|6.2||||0.048|TWO_SIDED|95.0|0.1|12.4|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||12.4|0.1|0.048
70994835|NCT03084718|141498336|SUPERIORITY||Mean Difference (Final Values)|2.6||||0.41|TWO_SIDED|95.0|-3.6|8.9|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||8.9|-3.6|0.410
71099684|NCT02739828|141708438|SUPERIORITY|||||||0.0016|||||||paired t-test|||Skin pain on average. Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0016
71040355|NCT03702816|141589080|OTHER|Linear Regression||||||0.39|||||||Regression, Linear|F=2.032||Linear Regression of Executive Function Composite Scores and Parietal GE180 SUVR in AD Subjects||||0.39
71040356|NCT03702816|141589080|OTHER|Linear Regression||||||0.031|||||||Regression, Linear|F=425.337||Linear Regression of Speed Composite Scores and Parietal GE180 SUVR in AD Subjects||||0.031
71040357|NCT03702816|141589080|OTHER|Linear Regression||||||0.274|||||||Regression, Linear|F=4.739||Linear Regression of Language Composite Scores and Parietal GE180 SUVR in AD Subjects||||0.274
71040358|NCT03702816|141589080|OTHER|Linear Regression||||||0.66|||||||Regression, Linear|F=0.263||Linear Regression of Memory Composite Scores and Parietal GE180 SUVR in PD Subjects||||0.66
71040359|NCT03702816|141589080|OTHER|Linear Regression||||||0.07|||||||Regression, Linear|F=12.244||Linear Regression of Executive Function Composite Scores and Parietal GE180 SUVR in PD Subjects||||0.07
71040360|NCT03702816|141589080|OTHER|Linear Regression||||||0.48|||||||Regression, Linear|F=0.762||Linear Regression of Speed Composite Scores and Parietal GE180 SUVR in PD Subjects||||0.48
71040361|NCT03702816|141589080|OTHER|Linear Regression||||||0.12|||||||Regression, Linear|F=7.107||Linear Regression of Language Composite Scores and Parietal GE180 SUVR in PD Subjects||||0.12
71040362|NCT03702816|141589081|OTHER|Linear Regression||||||0.85|||||||Regression, Linear|F=0.038||Linear Regression of Memory Composite Scores and Temporal GE180 SUVR in Control Subjects||||0.85
71040363|NCT03702816|141589081|OTHER|Linear Regression||||||0.84|||||||Regression, Linear|F=0.042||Linear Regression of Executive Function Composite Scores and Temporal GE180 SUVR in Control Subjects||||0.84
71040364|NCT03702816|141589081|OTHER|Linear Regression||||||0.35|||||||Regression, Linear|F=1.021||Linear Regression of Speed Composite Scores and Temporal GE180 SUVR in Control Subjects||||0.35
71040365|NCT03702816|141589081|OTHER|Linear Regression||||||0.25|||||||Regression, Linear|F=1.610||Linear Regression of Language Composite Scores and Temporal GE180 SUVR in Control Subjects||||0.25
71040366|NCT03702816|141589081|OTHER|Linear Regression||||||0.25|||||||Regression, Linear|F=1.779||Linear Regression of Memory Composite Scores and Temporal GE180 SUVR in MCI Subjects||||0.25
71040367|NCT03702816|141589081|OTHER|Linear Regression||||||0.54|||||||Regression, Linear|F=0.455||Linear Regression of Executive Function Composite Scores and Temporal GE180 SUVR in MCI Subjects||||0.54
71040368|NCT03702816|141589081|OTHER|Linear Regression||||||0.47|||||||Regression, Linear|F=0.650||Linear Regression of Speed Composite Scores and Temporal GE180 SUVR in MCI Subjects||||0.47
71040369|NCT03702816|141589081|OTHER|Linear Regression||||||0.74|||||||Regression, Linear|F=0.131||Linear Regression of Language Composite Scores and Temporal GE180 SUVR in MCI Subjects||||0.74
71040370|NCT03702816|141589081|OTHER|Linear Regression||||||0.83|||||||Regression, Linear|F=0.075||Linear Regression of Memory Composite Scores and Temporal GE180 SUVR in AD Subjects||||0.83
71040371|NCT03702816|141589081|OTHER|Linear Regression||||||0.41|||||||Regression, Linear|F=1.831||Linear Regression of Executive Function Composite Scores and Temporal GE180 SUVR in AD Subjects||||0.41
71040372|NCT03702816|141589081|OTHER|Linear Regression||||||0.83|||||||Regression, Linear|F=0.079||Linear Regression of Speed Composite Scores and Temporal GE180 SUVR in AD Subjects||||0.83
71040373|NCT03702816|141589081|OTHER|Linear Regression||||||0.52|||||||Regression, Linear|F=0.879||Linear Regression of Language Composite Scores and Temporal GE180 SUVR in AD Subjects||||0.52
71040374|NCT03702816|141589081|OTHER|Linear Regression||||||0.98|||||||Regression, Linear|F=0.001||Linear Regression of Memory Composite Scores and Temporal GE180 SUVR in PD Subjects||||0.98
71040375|NCT03702816|141589081|OTHER|Linear Regression||||||0.95|||||||Regression, Linear|F=0.005||Linear Regression of Executive Function Composite Scores and Temporal GE180 SUVR in PD Subjects||||0.95
71040376|NCT03702816|141589081|OTHER|Linear Regression||||||0.32|||||||Regression, Linear|F=1.733||Linear Regression of Speed Composite Scores and Temporal GE180 SUVR in PD Subjects||||0.32
71040377|NCT03702816|141589081|OTHER|Linear Regression||||||0.67|||||||Regression, Linear|F=0.249||Linear Regression of Language Composite Scores and Temporal GE180 SUVR in PD Subjects||||0.67
71040378|NCT03702816|141589082|OTHER|Linear Regression||||||0.76|||||||Regression, Linear|F=0.098||Linear Regression of DRS Scores and Whole Brain GE180 SUVR in Control Subjects||||0.76
71040379|NCT03702816|141589082|OTHER|Linear Regression||||||0.49|||||||Regression, Linear|F=0.513||Linear Regression of MoCA Scores and Whole Brain GE180 SUVR in Control Subjects||||0.49
71040380|NCT03702816|141589082|OTHER|Linear Regression||||||0.93|||||||Regression, Linear|F=0.008||Linear Regression of DRS Scores and Whole Brain GE180 SUVR in MCI Subjects||||0.93
71040381|NCT03702816|141589082|OTHER|Linear Regression||||||0.54|||||||Regression, Linear|F=0.430||Linear Regression of MoCA Scores and Whole Brain GE180 SUVR in MCI Subjects||||0.54
71040382|NCT03702816|141589082|OTHER|Linear Regression||||||0.77|||||||Regression, Linear|F=0.142||Linear Regression of DRS Scores and Whole Brain GE180 SUVR in AD Subjects||||0.77
71040383|NCT03702816|141589082|OTHER|Linear Regression||||||0.61|||||||Regression, Linear|F=0.496||Linear Regression of MoCA Scores and Whole Brain GE180 SUVR in AD Subjects||||0.61
71040384|NCT03702816|141589082|OTHER|Linear Regression||||||0.11|||||||Regression, Linear|F=8.046||Linear Regression of DRS Scores and Whole Brain GE180 SUVR in PD Subjects||||0.11
71040385|NCT03702816|141589082|OTHER|Linear Regression||||||0.84|||||||Regression, Linear|F=0.051||Linear Regression of MoCA Scores and Whole Brain GE180 SUVR in PD Subjects||||0.84
71040386|NCT00608634|141589089|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.10
71040387|NCT00608634|141589089|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
71040388|NCT00608634|141589090|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
71040389|NCT00749658|141589120|OTHER|Two tailed testing||||||0.07|||||||SAS|||||||0.07
71040390|NCT00633022|141589121|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.4519|TWO_SIDED|95.0|-0.14|0.06|||ANCOVA|ANCOVA model, fitting fixed effect treatment term, and including baseline TBR value as a covariate.ANCOVA model, fitting fixed effect treatment term,|The point estimate was calculated as least square mean difference (final values) of Losmapimod 7.5 mg twice daily and Placebo.|Losmapimod 7.5 mg BID versus Placebo||0.06|-0.14|0.4519
71099685|NCT02739828|141708439|SUPERIORITY|||||||0.0003|||||||paired t-test|||Skin pain at its worst. Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0003
70994836|NCT03084718|141498336|SUPERIORITY||Mean Difference (Final Values)|3.2||||0.32|TWO_SIDED|95.0|-3.1|9.4|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||9.4|-3.1|0.320
70994837|NCT03084718|141498336|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.867|TWO_SIDED|95.0|-5.7|6.8|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||6.8|-5.7|0.867
70994838|NCT03084718|141498336|SUPERIORITY||Mean Difference (Final Values)|9.0||||0.004|TWO_SIDED|95.0|2.9|15.0|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||15.0|2.9|0.004
70994839|NCT03084718|141498337|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.26|TWO_SIDED|95.0|-3.2|11.9|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||11.9|-3.2|0.260
71040391|NCT00633022|141589121|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.5789|TWO_SIDED|95.0|-0.11|0.06|||ANCOVA|ANCOVA model, fitting fixed effect treatment term, and including baseline TBR value as a covariate.|The point estimate was calculated as least square mean difference (final values) of Losmapimod 7.5 mg once daily and Placebo.|Losmapimod 7.5 mg once daily versus Placebo||0.06|-0.11|0.5789
71099686|NCT02739828|141708439|SUPERIORITY|||||||0.0094|||||||paired t-test|||Skin pain on average. Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0094
71099687|NCT02739828|141708443|SUPERIORITY|||||||0.0278|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0278
71099688|NCT02739828|141708444|SUPERIORITY|||||||0.0215|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0215
70994840|NCT03084718|141498337|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.387|TWO_SIDED|95.0|-4.2|10.9|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||10.9|-4.2|0.387
70994841|NCT03084718|141498337|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.574|TWO_SIDED|95.0|-5.4|9.7|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||9.7|-5.4|0.574
70994842|NCT03084718|141498337|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.799|TWO_SIDED|95.0|-8.6|6.7|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||6.7|-8.6|0.799
70994843|NCT03084718|141498337|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.577|TWO_SIDED|95.0|-9.8|5.5|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||5.5|-9.8|0.577
70994844|NCT03084718|141498337|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.764|TWO_SIDED|95.0|-8.8|6.5|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||6.5|-8.8|0.764
70994845|NCT03084718|141498337|SUPERIORITY||Mean Difference (Final Values)|6.0||||0.097|TWO_SIDED|95.0|-1.1|13.8|||Mixed Models Analysis|||"Inter-visit period 1~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||13.8|-1.1|0.097
70994846|NCT03084718|141498337|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.908|TWO_SIDED|95.0|-9.9|8.8|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||8.8|-9.9|0.908
71040392|NCT00633022|141589122|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.6986|TWO_SIDED|95.0|-0.15|0.1|||ANCOVA|ANCOVA model, fitting fixed effect treatment term, and including baseline TBR value as a covariate.|The point estimate was calculated as least square mean difference (final values) of Losmapimod 7.5 mg twice daily and Placebo.|Losmapimod 7.5 mg twice daily versus placebo||0.10|-0.15|0.6986
71040393|NCT00633022|141589122|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9486|TWO_SIDED|95.0|-0.13|0.12|||ANCOVA|ANCOVA model, fitting fixed effect treatment term, and including baseline TBR value as a covariate.|The point estimate was calculated as least square mean difference (final values) of Losmapimod 7.5 mg once daily and Placebo.|Losmapimod 7.5 mg once daily versus Placebo||0.12|-0.13|0.9486
71040394|NCT04388787|141589140|SUPERIORITY|||||||0.03|||||||ANCOVA|||||||0.03
71099689|NCT02739828|141708445|SUPERIORITY|||||||0.1652|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.1652
71099690|NCT02739828|141708449|SUPERIORITY|||||||1|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||1.0000
70994847|NCT03084718|141498337|SUPERIORITY||Mean Difference (Final Values)|7.0||||0.135|TWO_SIDED|95.0|-2.2|16.5|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||16.5|-2.2|0.135
70994848|NCT03084718|141498337|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.786|TWO_SIDED|95.0|-10.7|8.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo"||8.1|-10.7|0.786
70994849|NCT03084718|141498337|SUPERIORITY||Mean Difference (Final Values)|8.0||||0.109|TWO_SIDED|95.0|-1.7|17.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||17.1|-1.7|0.109
70994850|NCT03084718|141498337|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.876|TWO_SIDED|95.0|-10.1|8.7|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||8.7|-10.1|0.876
70994851|NCT03084718|141498337|SUPERIORITY||Mean Difference (Final Values)|-8.0||||0.08|TWO_SIDED|95.0|-17.9|1.0|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||1.0|-17.9|0.080
71040395|NCT04388787|141589141|SUPERIORITY|||||||0.0008|||||||ANCOVA|||||||0.0008
70994852|NCT03084718|141498337|SUPERIORITY||Mean Difference (Final Values)|6.0||||0.202|TWO_SIDED|95.0|-3.2|15.3|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||15.3|-3.2|0.202
70994853|NCT03084718|141498337|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.635|TWO_SIDED|95.0|-5.9|9.7|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||9.7|-5.9|0.635
70994854|NCT03084718|141498337|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.191|TWO_SIDED|95.0|-2.6|13.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||13.1|-2.6|0.191
70994855|NCT03084718|141498337|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.914|TWO_SIDED|95.0|-7.4|8.3|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||8.3|-7.4|0.914
70994856|NCT03084718|141498337|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.407|TWO_SIDED|95.0|-4.6|11.3|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||11.3|-4.6|0.407
70994857|NCT03084718|141498337|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.718|TWO_SIDED|95.0|-9.4|6.4|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||6.4|-9.4|0.718
70994858|NCT03084718|141498337|SUPERIORITY||Mean Difference (Final Values)|-5.0||||0.235|TWO_SIDED|95.0|-12.7|3.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||3.1|-12.7|0.235
70994859|NCT03084718|141498337|SUPERIORITY||Mean Difference (Final Values)|6.0||||0.118|TWO_SIDED|95.0|-1.6|13.9|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||13.9|-1.6|0.118
70994860|NCT02767856|141498344|EQUIVALENCE|The study did not enroll enough samples. The stats here are only for reference.|Mean Difference (Net)|0.04||||0.48|TWO_SIDED|95.0|-0.08|0.16|||t-test, 2 sided|||Baseline and primary visit outcome||0.16|-0.08|0.48
70994861|NCT02767856|141498345|EQUIVALENCE|The study did not reach the target sample size. the stats are for reference.|Mean Difference (Final Values)|0.12||||0.26|TWO_SIDED|95.0|-0.75|0.99|||t-test, 2 sided|||||0.99|-0.75|0.26
71099691|NCT02739828|141708450|SUPERIORITY|||||||1|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||1.0000
71099692|NCT02739828|141708451|SUPERIORITY|||||||0.5|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.5000
70994862|NCT02767856|141498346|EQUIVALENCE|The study did not reach the target sample size. The stats are for reference.|Mean Difference (Final Values)|26.3||||0.26|TWO_SIDED|95.0|-21.75|74.2|||t-test, 2 sided|||||74.20|-21.75|0.26
70994863|NCT02767856|141498347|EQUIVALENCE|The study did not reach the target sample size. The stats are for reference.|Mean Difference (Final Values)|11.1||||0.44|TWO_SIDED|95.0|-41.3|19.3|||t-test, 2 sided|||||19.3|-41.3|0.44
70994864|NCT00091026|141498348|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||0.22|TWO_SIDED|95.0|-13.0|14.0|||Chi-squared|||||14|-13|0.22
70994865|NCT00091026|141498349|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||Log Rank|||||||0.95
70994866|NCT00091026|141498350|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Log Rank|||||||0.86
70994867|NCT00589979|141498353|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.78||||0.1006||95.0|0.89|3.55||All statistical tests were 2-sided with a significance level of alpha=0.05.|Cox frailty model|Model included treatment, sequence, period, and first-order carryover as fixed effects and frailty; patient nested within sequence was frailty.|The Hazard Ratio (HR) provided is the ratio of Placebo to Lidoderm.|The two treatments were compared by time-varying relative hazards, associated P values, and 95% confidence intervals. Appropriate survival or hazard functions were calculated.||3.55|0.89|0.1006
70994868|NCT00589979|141498355|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.86||||0.1272||95.0|0.86|4.02||The logistic regression model for repeated measures used for this analysis included treatment, sequence, period, and first-order carry-over as fixed effects and repeated measures taken on patients nested within sequence.|Regression, Logistic|The results presented are reported in terms of odds ratios, corresponding 95% confidence intervals, and P-values for each fixed effect in the model.|The Odds Ratio (OR) provided is the ratio of Lidoderm to Placebo.|The proportion of patients who exited from the current treatment period prior to the 4-week planned duration was analyzed using a logistic regression model for repeated measures.||4.02|0.86|0.1272
70994869|NCT00589979|141498356|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.54||||0.0224||95.0|-1.01|-0.08||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects model||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||-0.08|-1.01|0.0224
71040396|NCT03298880|141589142|SUPERIORITY||Mean Difference (Net)|3.7|STANDARD_ERROR_OF_MEAN|1.12|<|0.001|TWO_SIDED|95.0|2.1|5.3|||mixed linear regression|||||5.3|2.1|<0.001
71040397|NCT03298880|141589142|SUPERIORITY||Mean Difference (Net)|2.3||||0.003|TWO_SIDED|95.0|0.8|3.8|||mixed linear regression|||||3.8|0.8|0.003
71040398|NCT02940522|141589150|OTHER|Comparison of bioavailability|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.|||
71040399|NCT02940522|141589151|OTHER|Comparison of bioavailability data|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.|||
71040400|NCT02940522|141589152|OTHER|Comparison of bioavailability data|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.|||
70923522|NCT03655132|141338678|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|14.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<.001
70994870|NCT00589979|141498357|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.2747||95.0|-0.31|1.09||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects regression||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||1.09|-0.31|0.2747
70994871|NCT00589979|141498358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.4498||95.0|-0.8|0.36||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects model||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Intense: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.36|-0.80|0.4498
70994872|NCT00589979|141498358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.1065||95.0|-1.11|0.11||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effect models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Sharp: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.11|-1.11|0.1065
70994873|NCT00589979|141498358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.0484||95.0|-0.94|0.0||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Hot: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||-0.00|-0.94|0.0484
70923523|NCT03655132|141338679|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|0.5||||0.13|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.13
70994874|NCT00589979|141498358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24||||0.4973||95.0|-0.93|0.46||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effect models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Dull: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.46|-0.93|0.4973
70994875|NCT00589979|141498358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12||||0.3966||95.0|-0.16|0.41||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effect models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Cold: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.41|-0.16|0.3966
70994876|NCT00589979|141498358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.6941||95.0|-0.53|0.35||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects model||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Sensitive: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.35|-0.53|0.6941
70923524|NCT03655132|141338679|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|3.0||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.07
70923525|NCT03655132|141338680|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|0.0||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.64
70923526|NCT03655132|141338680|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|-0.3||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.30
70923527|NCT03655132|141338681|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|0.5||||0.75|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.75
70923528|NCT03655132|141338681|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|-0.5||||0.6|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.60
70994877|NCT00589979|141498358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18||||0.5664||95.0|-0.45|0.82||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Tender: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.82|-0.45|0.5664
70994878|NCT00589979|141498358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.6871||95.0|-0.55|0.37||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Itchy: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.37|-0.55|0.6871
70994879|NCT00589979|141498358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41||||0.2318||95.0|-1.08|0.27||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Shocking: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.27|-1.08|0.2318
70994880|NCT00589979|141498358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21||||0.3383||95.0|-0.64|0.22||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Numb: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.22|-0.64|0.3383
70994881|NCT00589979|141498358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.874||95.0|-0.63|0.73||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Electrical: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.73|-0.63|0.8740
70994882|NCT00589979|141498358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.999||95.0|-0.54|0.54||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Tingling: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.54|-0.54|0.9990
71040401|NCT02940522|141589153|OTHER|Comparison of bioavailability data|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.|||
71040402|NCT02940522|141589154|OTHER|Comparison of bioavailability data|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.|||
71099693|NCT02739828|141708452|SUPERIORITY|||||||0.1797|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.1797
71099694|NCT02739828|141708453|SUPERIORITY|||||||0.4531|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.4531
71099695|NCT02739828|141708454|SUPERIORITY|||||||0.0313|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0313
71099696|NCT02739828|141708455|SUPERIORITY|||||||0.3438|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.3438
71099697|NCT02739828|141708456|SUPERIORITY|||||||0.4531|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.4531
70994883|NCT00589979|141498358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.4183||95.0|-0.85|0.36||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Cramping: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.36|-0.85|0.4183
70994884|NCT00589979|141498358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.8227||95.0|-0.71|0.57||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Radiating: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.57|-0.71|0.8227
70994885|NCT00589979|141498358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18||||0.587||95.0|-0.48|0.85||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Throbbing: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.85|-0.48|0.5870
70994886|NCT00589979|141498358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.2181||95.0|-1.15|0.27||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Aching: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.27|-1.15|0.2181
70994887|NCT00589979|141498358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.6276||95.0|-0.68|0.42||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Heavy: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.42|-0.68|0.6276
71040403|NCT02940522|141589155|OTHER|Comparison of bioavailability data|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.|||
71040404|NCT04980456|141589176|NON_INFERIORITY|Noninferiority in distance VA was declared if the least squares means difference upper confidence limit was less than 0.05.|Least Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.003|||ONE_SIDED|95.0||0.01||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, visit, lens by visit interaction, period, and sequence) and random (subject) effects. Difference = TOTAL30 minus Biofinity|||0.01||
71040405|NCT04832971|141589177|SUPERIORITY||Difference vs. Placebo at Week 24|-51.22|||<|0.0001|TWO_SIDED|95.0|-61.73|-40.7||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures (MMRM)||ARO-ANG3 - Placebo|||-40.70|-61.73|<.0001
71040406|NCT04832971|141589177|SUPERIORITY||||||<|0.0001||||||The adjusted p-value is calculated using the Holm method for multiplicity adjustment.|Holm method|||||||<.0001
71040407|NCT04832971|141589177|SUPERIORITY||Difference vs Placebo at Week 24|-56.56|||<|0.0001|TWO_SIDED|95.0|-67.09|-46.04||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures (MMRM)||ARO-ANG3 - Placebo|||-46.04|-67.09|<.0001
71040408|NCT04832971|141589177|SUPERIORITY||||||<|0.0001||||||The adjusted p-value is calculated using the Holm method for multiplicity adjustment.|Holm method|||||||<.0001
71099698|NCT02739828|141708457|SUPERIORITY|||||||0.0156|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0156
71040409|NCT04832971|141589177|SUPERIORITY||Difference vs. Placebo at Week 24|-63.11|||<|0.0001|TWO_SIDED|95.0|-73.56|-52.66||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model with Repeated Measures|||||-52.66|-73.56|<.0001
71040410|NCT04832971|141589177|SUPERIORITY||||||<|0.0001||||||The adjusted p-value is calculated using the Holm method for multiplicity adjustment.|Holm method|||||||<.0001
71040411|NCT04832971|141589179|SUPERIORITY||Difference vs. Placebo at Week 24|-29.2|||<|0.0001|TWO_SIDED|95.0|-38.5|-20.0||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-20.0|-38.5|<.0001
71040412|NCT04832971|141589179|SUPERIORITY||Difference vs. Placebo at Week 24|-28.7|||<|0.0001|TWO_SIDED|95.0|-37.9|-19.5||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-19.5|-37.9|<.0001
71040413|NCT04832971|141589179|SUPERIORITY||Difference vs. Placebo at Week 24|-36.4|||<|0.0001|TWO_SIDED|95.0|-45.5|-27.2||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-27.2|-45.5|<.0001
71040414|NCT04832971|141589181|SUPERIORITY||Difference vs. Placebo at Week 24|-18.66|||<|0.0001|TWO_SIDED|95.0|-26.53|-10.8||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-10.80|-26.53|<.0001
71040415|NCT04832971|141589181|SUPERIORITY||Difference vs. Placebo at Week 24|-15.18||||0.0002|TWO_SIDED|95.0|-23.0|-7.36||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-7.36|-23.00|0.0002
71040416|NCT04832971|141589181|SUPERIORITY||Difference vs. Placebo at Week 24|-21.9|||<|0.0001|TWO_SIDED|95.0|-29.69|-14.12||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-14.12|-29.69|<.0001
71040417|NCT04832971|141589183|SUPERIORITY||Difference vs. Placebo at Week 24|-16.0||||0.0138|TWO_SIDED|95.0|-28.7|-3.3||Model includes treatment arm, study visit, and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-3.3|-28.7|0.0138
71040418|NCT04832971|141589183|SUPERIORITY||Difference vs Placebo at Week 24|-9.3||||0.148|TWO_SIDED|95.0|-22.0|3.3||Model includes treatment arm, study visit, and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repated Measures|||||3.3|-22.0|0.1480
71040419|NCT04832971|141589183|SUPERIORITY||Difference vs Placebo at Week 24|-20.2||||0.0019|TWO_SIDED|95.0|-32.8|-7.5||Model includes treatment arm, study visit, and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mxed Models Repeated Measures|||||-7.5|-32.8|0.0019
70994888|NCT00589979|141498358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57||||0.0917||95.0|-1.23|0.09||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Overall unpleasantness: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.09|-1.23|0.0917
71040420|NCT04832971|141589185|SUPERIORITY||Difference vs Placebo|-54.26|||<|0.0001|TWO_SIDED|95.0|-62.11|-46.4||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|mixed Models Repeated Measures|||||-46.40|-62.11|<.0001
71099699|NCT02739828|141708458|SUPERIORITY|||||||0.0386|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0386
71099700|NCT02739828|141708459|SUPERIORITY|||||||0.3438|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.3438
71099701|NCT02739828|141708460|SUPERIORITY|||||||0.125|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.1250
71099702|NCT02739828|141708461|SUPERIORITY|||||||0.0625|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0625
71099703|NCT02739828|141708462|SUPERIORITY|||||||0.0625|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0625
71099704|NCT02739828|141708463|SUPERIORITY|||||||0.125|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.1250
71099705|NCT01953354|141708474|SUPERIORITY_OR_OTHER|||||||1||||||P-value is testing for a difference in proportions using a Fisher's exact test.|Fisher Exact|||||||1.000
71099706|NCT01953354|141708475|SUPERIORITY_OR_OTHER|||||||1||||||P-value is testing for a difference in proportions using a Fisher's exact test.|Fisher Exact|||||||1.000
71099707|NCT01953354|141708476|SUPERIORITY_OR_OTHER|||||||0.242||||||P-value is testing for a difference in proportions using a Fisher's exact test.|Fisher Exact|||||||0.242
71099708|NCT01953354|141708477|SUPERIORITY_OR_OTHER|||||||0.55||||||P-value is testing for a difference in proportions using a Fisher's exact test.|Fisher Exact|||||||0.550
71099709|NCT01953354|141708480|SUPERIORITY_OR_OTHER|||||||0.55||||||P-value is testing for a difference in proportions using a Fisher's exact test.|Fisher Exact|||||||0.550
71099710|NCT01953354|141708481|SUPERIORITY_OR_OTHER|||||||0.633||||||P-value is testing for a difference in proportions using a Fisher's exact test.|Fisher Exact|||||||0.633
70994889|NCT00589979|141498358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.2089||95.0|-1.13|0.25||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Intense deep pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.25|-1.13|0.2089
70994890|NCT00589979|141498358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.4188||95.0|-0.75|0.31||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Intense surface pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.31|-0.75|0.4188
70994891|NCT00589979|141498358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.6959||95.0|-0.32|0.21||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Average surface pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.21|-0.32|0.6959
70994892|NCT00589979|141498358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.4806||95.0|-0.64|0.3||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Average deep pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.30|-0.64|0.4806
71040421|NCT04832971|141589185|SUPERIORITY||Difference vs Placebo at Week 24|-69.76|||<|0.0001|TWO_SIDED|95.0|-77.58|-61.95||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-61.95|-77.58|<.0001
71040422|NCT04832971|141589185|SUPERIORITY||Difference vs Placebo at Week 24|-73.69|||<|0.0001|TWO_SIDED|95.0|-81.44|-65.93||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-65.93|-81.44|<.0001
71099711|NCT02965976|141708495|SUPERIORITY|||||||0.773|||||||Cochran-Mantel-Haenszel|||||||0.773
71099712|NCT02965976|141708496|SUPERIORITY|||||||0.773|||||||Cochran-Mantel-Haenszel|||||||0.773
71099713|NCT02965976|141708497|SUPERIORITY|||||||0.368|||||||t-test, 2 sided|||||||0.368
71099714|NCT02965976|141708498|SUPERIORITY|||||||0.987|||||||t-test, 2 sided|||||||0.987
71099715|NCT02965976|141708499|SUPERIORITY|||||||0.423|||||||Cochran-Mantel-Haenszel|||||||0.423
71099716|NCT02965976|141708500|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||||||1.000
71099717|NCT00806026|141708503|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|-4.5|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-5.9|-3.2||This analysis was step 1 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pregabalin 300 mg versus placebo: Mixed model analysis was used to analyze RLS symptom severity score with baseline value, region \[United states (US) or European union (EU)\], treatment, week and treatment by week interaction as fixed effects.||-3.20|-5.90|<0.0001
71099718|NCT00806026|141708503|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.68||0.3603|TWO_SIDED|95.0|-2.0|0.7||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.25 mg versus placebo: Mixed model analysis was used to analyze RLS symptom severity score with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||0.7|-2.0|0.3603
71099719|NCT00806026|141708503|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.2|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-4.5|-1.9||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.5 mg versus placebo: Mixed model analysis was used to analyze RLS symptom severity score with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||-1.9|-4.5|<0.0001
71099720|NCT00806026|141708504|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||This analysis was step 2 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Cochran-Mantel-Haenszel|||For pregabalin 300 mg versus placebo: Cochran-Mantel-Haenszel (CMH) test stratified by geographical region (US or EU) was used to analyze CGI-I responder status.||||<0.0001
70994893|NCT00589979|141498358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28||||0.2291||95.0|-0.74|0.18||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Average paroxysmal pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.18|-0.74|0.2291
70994894|NCT00589979|141498359|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.3185||95.0|0.77|2.27||All statistical tests were 2-sided with a significance level of alpha=0.05.|Regression, Linear||The Odds Ratio (OR) provided is the ratio of Lidoderm to Placebo.|Global impression of change from baseline with the lidocaine patch 5% and placebo patch were compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects, with repeated measures taken on patient within sequence.||2.27|0.77|0.3185
70994895|NCT00589979|141498360|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.4748||95.0|0.72|2.06||All statistical tests were 2-sided with a significance level of alpha=0.05.|Regression, Linear||The odds ratio (OR) provided is the ratio of Lidoderm to Placebo.|Global impression of change from baseline with the lidocaine patch 5% and placebo patch were compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects, with repeated measures taken on patient within sequence.||2.06|0.72|0.4748
70994896|NCT00589979|141498361|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12||||0.7839||95.0|-0.74|0.98||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.98|-0.74|0.7839
70994897|NCT00589979|141498363|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.3773||95.0|-0.02|0.04||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects model||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.04|-0.02|0.3773
70994898|NCT00589979|141498364|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.2605||95.0|0.38|1.3||All statistical tests were 2-sided with a significance level of alpha=0.05.|Regression, Linear||The odds ratio (OR) provided is the ratio of Lidoderm to Placebo.|Treatment satisfaction with the lidocaine patch 5% and placebo patch were compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects, with repeated measures taken on patient within sequence.||1.30|0.38|0.2605
70994899|NCT00589979|141498365|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.3193||95.0|0.44|1.3||All statistical tests were 2-sided with a significance level of alpha=0.05.|Regression, Linear||The odds ratio (OR) provided is the ratio of Lidoderm to Placebo.|Treatment satisfaction with the lidocaine patch 5% and placebo patch were compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects, with repeated measures taken on patient within sequence.||1.30|0.44|0.3193
70994900|NCT00589979|141498366|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.74||||0.1378||95.0|-0.57|4.04||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects model||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates||4.04|-0.57|0.1378
70994901|NCT00589979|141498367|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.6833||95.0|0.47|1.65||All statistical tests were 2-sided with a significance level of alpha=0.05.|Regression, Logistic|An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects.|The Odds Ratio (OR) provided is the ratio of Lidoderm to Placebo.|||1.65|0.47|0.6833
71099721|NCT00806026|141708504|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4393|TWO_SIDED|||||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Cochran-Mantel-Haenszel|||For pramipexole 0.25 mg versus placebo: CMH test stratified by geographical region (US or EU) was used to analyze CGI-I responder status.||||0.4393
71099722|NCT00806026|141708504|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0022|TWO_SIDED|||||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Cochran-Mantel-Haenszel|||For pramipexole 0.5 mg versus placebo: CMH test stratified by geographical region (US or EU) was used to analyze CGI-I responder status.||||0.0022
70994902|NCT00589979|141498368|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.16||||0.1143||95.0|-5.48|49.8||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Disturbance: the overall treatment difference for Lidoderm and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||49.8|-5.48|0.1143
70994903|NCT00589979|141498368|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.18||||0.9108||95.0|-19.8|22.2||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Effectiveness: the overall treatment difference for Lidoderm and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||22.2|-19.8|0.9108
70994904|NCT00589979|141498368|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.31||||0.3769||95.0|-10.3|27.0||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Supplementation: the overall treatment difference for Lidoderm and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||27.0|-10.3|0.3769
70994905|NCT01397448|141498370|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.11|||<|0.001|TWO_SIDED|95.0|0.04|0.31|||Log Rank|||||0.31|0.04|<0.001
70994906|NCT01397448|141498370|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.05|||<|0.001|TWO_SIDED|95.0|0.01|0.23|||Log Rank|||||0.23|0.01|<0.001
70994907|NCT02475395|141498401|OTHER||Sensitivity|90.0|||||TWO_SIDED|95.0|79.9|95.3|||||Sensitivity estimates the percent true positive results obtained by Trak. Positive results are less than 15 M/mL sperm concentration and are part of a sub fertile diagnostic assessment.|||95.3|79.9|
70994908|NCT02475395|141498401|OTHER||Specificity|93.3|||||TWO_SIDED|95.0|88.7|96.1|||||Specificity is calculated by the percentage of true negative results obtained using Trak compared to reference method. Negative (for subfertility) results are greater than 15 M/mL.|||96.1|88.7|
70994909|NCT02475395|141498402|OTHER||Sensitivity|95.0|||||TWO_SIDED|95.0|86.3|98.3||||||||98.3|86.3|
70994910|NCT02475395|141498402|OTHER||Specificity|94.9|||||TWO_SIDED|95.0|90.6|97.3||||||||97.3|90.6|
70994911|NCT02475395|141498403|OTHER||Sensitivity|96.7|||||TWO_SIDED|95.0|88.7|99.1||||||||99.1|88.7|
70994912|NCT02475395|141498403|OTHER||Specificity|93.8|||||TWO_SIDED|95.0|89.2|96.5||||||||96.5|89.2|
70994913|NCT00383721|141498405|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
70994914|NCT00383721|141498405|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
71099723|NCT00806026|141708505|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0826|TWO_SIDED|||||This analysis was step 6 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Log Rank|||For pramipexole 0.25 mg versus pregabalin 300 mg: Stratified log rank test by block (40 weeks versus 52 weeks of active treatment) was used to calculate p-value.||||0.0826
71099724|NCT00806026|141708505|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012|TWO_SIDED|||||This analysis was step 3 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Log Rank|||For pramipexole 0.5 mg versus pregabalin 300 mg: Stratified log rank test by block (40 weeks versus 52 weeks of active treatment) was used to calculate p-value.||||0.0012
70994915|NCT00383721|141498406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062|||||||ANCOVA|||||||0.062
70994916|NCT00383721|141498406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.583|||||||ANCOVA|||||||0.583
70994917|NCT00383721|141498407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||ANCOVA|||||||0.020
70994918|NCT00383721|141498407|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
70994919|NCT03784027|141498412|SUPERIORITY||Mean Difference (Final Values)|8.7|||<|0.001|TWO_SIDED|95.0|7.4|9.9|||Regression, Linear||The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|||9.9|7.4|<0.001
70994920|NCT03784027|141498413|SUPERIORITY||Mean Difference (Final Values)|-8.5|||<|0.001|TWO_SIDED|95.0|-9.9|-7.1||The primary and key secondary end points were tested in hierarchy (Time in range, time \>180mg/dL, HbA1c, mean glucose, time \<70mg/dL) to control the type 1 error with the use of the fixed-sequence method.|Regression, Linear||The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|||-7.1|-9.9|<0.001
70994921|NCT03784027|141498414|SUPERIORITY||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.5|-0.3||The primary and key secondary end points were tested in hierarchy (Time in range, time \>180mg/dL, HbA1c, mean glucose, time \<70mg/dL) to control the type 1 error with the use of the fixed-sequence method.|Regression, Linear||The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|||-0.3|-0.5|<0.001
70994922|NCT03784027|141498415|SUPERIORITY||Mean Difference (Final Values)|-3.9|||<|0.001|TWO_SIDED|95.0|-4.9|-2.9|||Mixed Models Analysis|||||-2.9|-4.9|<0.001
70994923|NCT03784027|141498416|SUPERIORITY||Mean Difference (Final Values)|-12.3|||<|0.001|TWO_SIDED|95.0|-14.8|-9.8||The primary and key secondary end points were tested in hierarchy (Time in range, time \>180mg/dL, HbA1c, mean glucose, time \<70mg/dL) to control the type 1 error with the use of the fixed-sequence method.|Regression, Linear||The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|||-9.8|-14.8|<0.001
70994924|NCT03784027|141498417|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.74|TWO_SIDED|95.0|-0.4|0.5||The primary and key secondary end points were tested in hierarchy (Time in range, time \>180mg/dL, HbA1c, mean glucose, time \<70mg/dL) to control the type 1 error with the use of the fixed-sequence method.|Regression, Linear|||||0.5|-0.4|0.74
70994925|NCT03784027|141498418|SUPERIORITY|The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|Mean Difference (Final Values)|-6.2|||||TWO_SIDED|95.0|-7.6|-4.8|||||Confidence intervals for the secondary end points were adjusted for multiple comparisons with the use of the Benjamini-Hochberg procedure to control the false discovery rate.|||-4.8|-7.6|
70994926|NCT03784027|141498419|SUPERIORITY|The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values. Differences in percents are shown in percentage points.|Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-1.5|0.05|||||Confidence intervals for the secondary end points were adjusted for multiple comparisons with the use of the Benjamini-Hochberg procedure to control the false discovery rate.|||0.05|-1.5|
70994927|NCT03784027|141498420|SUPERIORITY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.1|0.1||The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|||Confidence intervals for the secondary end points were adjusted for multiple comparisons with the use of the Benjamini-Hochberg procedure to control the false discovery rate.|||0.1|-0.1|
70994928|NCT03784027|141498421|SUPERIORITY|The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-1.6|-0.6|||||Confidence intervals for the secondary end points were adjusted for multiple comparisons with the use of the Benjamini-Hochberg procedure to control the false discovery rate.|||-0.6|-1.6|
70994929|NCT03784027|141498422|NON_INFERIORITY|The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|Mean Difference (Final Values)|0.002|||||TWO_SIDED|95.0|-0.006|0.009|||||Confidence intervals for the secondary end points were adjusted for multiple comparisons with the use of the Benjamini-Hochberg procedure to control the false discovery rate.|||0.009|-0.006|
70994930|NCT03784027|141498423|SUPERIORITY||Mean Difference (Final Values)|0.004||||0.75|TWO_SIDED|95.0|-0.02|0.03|||Regression, Linear|Based on a longitudinal model adjusting for baseline value and period as fixed effects. The model accounts for correlated data from the same subject.||||0.03|-0.02|0.75
70994931|NCT03784027|141498424|SUPERIORITY|The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.1|0.8|||||(For total daily insulin use) Confidence intervals for the secondary end points were adjusted for multiple comparisons with the use of the Benjamini-Hochberg procedure to control the false discovery rate.|||0.8|-0.1|
70994932|NCT00915538|141498480|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The expected results for non-inferiority would be +/- 5% of difference between the two groups in the primary efficacy parameter.|AUC|0.0||||0.76|TWO_SIDED||||||t-test, 2 sided|||The cross-over means there were 16 determinants for each time for each treatment. The AUC of FEV-1 was measured in each subject for each treatment arm and the mean of this data was compared.||||0.76
70994933|NCT00915538|141498480|OTHER|Two sample T test|Mean Difference (Net)|0.0|STANDARD_DEVIATION|12.0|>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
70994934|NCT00915538|141498481|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power calculation was not done for secondary parameter. The comparison was for the FEV-1/FVC expressed as fraction at each time point||||||0.76|TWO_SIDED|95.0|||||t-test, 2 sided|||The cross over means there were 16 determinants for each time for each treatment||||0.76
70994935|NCT01253187|141498482|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|106.03||||||90.0|98.86|113.72||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / YAZ\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|38 volunteers qualified for statistical analysis of BE whereas all 39 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||113.72|98.86|
70994936|NCT01253187|141498483|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|103.47||||||90.0|99.16|107.98||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / YAZ\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|38 volunteers qualified for statistical analysis of BE whereas all 39 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||107.98|99.16|
71040423|NCT04832971|141589187|SUPERIORITY||Difference vs Placebo at Week 24|-12.0||||0.0039|TWO_SIDED|95.0|-20.2|-3.9||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-3.9|-20.2|0.0039
70994937|NCT01253187|141498484|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|105.24||||||90.0|97.3|113.83||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / YAZ\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|33 volunteers qualified for statistical analysis of BE whereas all 35 (YAZ) and 36 (EE20/DRSP/L-5-MTHF Ca) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||113.83|97.30|
70994938|NCT01253187|141498485|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|100.48||||||90.0|97.28|103.79||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / YAZ\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|33 volunteers qualified for statistical analysis of BE whereas all 35 (YAZ) and 36 (EE20/DRSP/L-5-MTHF Ca) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||103.79|97.28|
70994939|NCT01253187|141498486|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|99.88||||||90.0|91.24|109.34||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|39 volunteers qualified for statistical analysis of BE whereas all 39 (EE20/DRSP/L-5-MTHF Ca) and 40 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||109.34|91.24|
70994940|NCT01253187|141498487|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|98.16||||||90.0|93.95|102.57||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|39 volunteers qualified for statistical analysis of BE whereas all 39 (EE20/DRSP/L-5-MTHF Ca) and 40 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||102.57|93.95|
70994941|NCT01253187|141498488|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|100.28||||||90.0|93.15|107.95||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|40 volunteers qualified for statistical analysis of BE and all 40 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||107.95|93.15|
70994942|NCT01253187|141498489|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|99.88||||||90.0|95.38|104.58||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|40 volunteers qualified for statistical analysis of BE and all 40 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||104.58|95.38|
70994943|NCT01253187|141498491|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|100.3||||||90.0|97.65|103.02||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / YAZ\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|32 volunteers qualified for statistical analysis of BE whereas all 34 (YAZ) and 36 (EE20/DRSP/L-5-MTHF Ca) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||103.02|97.65|
70994944|NCT01295580|141498573|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"This is a non-inferiority test. The non-inferiority margin of +1.6 units corresponds to an 8% margin on the pain subscale (range 0-20)~Alpha inflation was controlled using pre-planned stepwise hypotheses testing (1) WOMAC Pain over 18 weeks then (2) over 26 weeks, (3) WOMAC Physical Function over 18 weeks then (4) over 26 weeks, (5) Subject Global Assessment over 18 weeks then (6) over 26 weeks, (7) WOMAC Knee Stiffness over 18 weeks then (8) over 26 weeks."|Mean Difference (Final Values)|-0.09|||||TWO_SIDED|95.0|-0.58|0.39||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the first step WOMAC pain over 18 week pain subscale primary analyses.||The second step is to test Durolane WOMAC pain non-inferior to Artz WOMAC pain over 26 weeks.||"Primary Hypothesis:~Ho: μDUR\[18\] - μArtz\[18\] ≥ +1.6 units Ha: μDUR\[18\] - μArtz\[18\] \< +1.6 units~Power Calculations:~Assume the over 18 weeks difference is 0mm, SD 20mm (5 on the Likert scale), 90% power, 2-sided test alpha 5%, and a 8mm non-inferiority margin (1.6 on the Likert scale), the sample size required is 132 subjects per group adjusted to 175 to hold power constant due to loss to follow-up and dropout."||0.39|-0.58|
70994945|NCT01295580|141498574|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of +1.6 units corresponds to an 8% margin on the pain subscale (range 0-20)|Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.56|0.37||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first pain over 18 weeks then pain over 26 weeks. This section reports the over 26 week pain subscale results.||The third ordered test is Durolane WOMAC physical function subscale non-inferior to Artz WOMAC physical function subscale over 18 weeks.||Ho: μDUR\[26\] - μArtz\[26\] ≥ +1.6 units Ha: μDUR\[26\] - μArtz\[26\] \< +1.6 units||0.37|-0.56|
70994946|NCT01295580|141498575|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of +5.44 units corresponds to an 8% margin on the physical function subscale (range 0-68).|Mean Difference (Final Values)|-0.65|||||TWO_SIDED|95.0|-1.81|0.51||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the over 18 week physical function results.||The fourth step is to test Durolane WOMAC physical function non-inferior to Artz physical function over 26 weeks.||Ho: μDUR\[18\] - μArtz\[18\] ≥ +5.44 units Ha: μDUR\[18\] - μArtz\[18\] \< +5.44 units||0.51|-1.81|
70994947|NCT01295580|141498576|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of +5.44 units corresponds to an 8% margin on the physical function subscale (range 0-68).|Mean Difference (Final Values)|-0.58|||||TWO_SIDED|95.0|-1.69|0.53||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the over 26 week physical function subscale results.||The fifth step is to test Durolane subject global assessment non-inferior to Artz global assessment over 18 weeks.||Ho: μDUR\[26\] - μArtz\[26\] ≥ +5.44 units Ha: μDUR\[26\] - μArtz\[26\] \< +5.44 units||0.53|-1.69|
70994948|NCT01295580|141498577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of -0.8 units corresponds to an 8% margin on the subject global assessment (range 0-10). Note that because the assessment interpretation is reversed as compared to the WOMAC assessments the lower bound of the 95%CI is compared to the -0.8 non-inferiority margin.|Mean Difference (Final Values)|0.15|||||TWO_SIDED|95.0|-0.15|0.45||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the over 18 week subject global assessment results.||The sixth step is to test Durolane subject global assessment non-inferior to Artz subject global assessment over 26 weeks.||Ho: μDUR\[18\] - μArtz\[18\] ≤ -0.8 units Ha: μDUR\[18\] - μArtz\[18\] \> -0.8 units||0.45|-0.15|
70994949|NCT01295580|141498578|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of -0.8 units corresponds to an 8% margin on the subject global assessment (range 0-10). Note that because the assessment interpretation is reversed as compared to the WOMAC assessments the lower bound of the 95%CI is compared to the -0.8 non-inferiority margin.|Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-0.16|0.43||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the over 26 week subject global assessment results.||The seventh step is to test Durolane WOMAC knee stiffness non-inferior to Artz WOMAC knee stiffness over 18 weeks.||Ho: μDUR\[18\] - μArtz\[18\] ≤ -0.8 units Ha: μDUR\[18\] - μArtz\[18\] \> -0.8 units||0.43|-0.16|
70994950|NCT01295580|141498579|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of +0.64 units corresponds to an 8% margin on the knee stiffness subscale (range 0-8).|Mean Difference (Final Values)|-0.14|||||TWO_SIDED|95.0|-0.33|0.05||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the over 18 week knee stiffness subscale results.||The eight and last step is to test Durolane WOMAC knee stiffness non-inferior to Artz WOMAC knee stiffness over 26 weeks.||Ho: μDUR\[18\] - μArtz\[18\] ≥ +0.64 units Ha: μDUR\[18\] - μArtz\[18\] \< +0.64 units||0.05|-0.33|
70994951|NCT01295580|141498580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of 0.64 units corresponds to an 8% margin on the knee stiffness subscale (range 0-8).|Mean Difference (Final Values)|-0.15|||||TWO_SIDED|95.0|-0.33|0.03||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the over 26 week knee stiffness subscale results.||This is the eighth and last pre-planned hypothesis test.||Ho: μDUR\[26\] - μArtz\[26\] ≥ +0.64 units Ha: μDUR\[26\] - μArtz\[26\] \< +0.64 units||0.03|-0.33|
70994952|NCT00865189|141498675|SUPERIORITY_OR_OTHER|||||||0.015|||||||Binomial test|||This proportion was described for each treatment arm with a 95% confidence interval (CI) and compared with the standard proportion of 10% (CI) for each treatment arm.||||0.015
70994953|NCT00865189|141498675|SUPERIORITY_OR_OTHER|||||||0.906|||||||Binomial test|||This proportion was described for each treatment arm with a 95% CI and compared with the standard proportion of 10% (CI) using for each treatment arm.||||0.906
71040424|NCT04832971|141589187|SUPERIORITY||Difference vs Placebo at Week 24|-21.6|||<|0.0001|TWO_SIDED|95.0|-29.8|-13.4||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-13.4|-29.8|<.0001
71040425|NCT04832971|141589187|SUPERIORITY||Differeence vs Placebo at week 24|-24.5|||<|0.0001|TWO_SIDED|95.0|-32.6|-16.5||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-16.5|-32.6|<.0001
71040426|NCT00706719|141589204|SUPERIORITY_OR_OTHER|||||||0.118|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Baseline.||||0.118
71040427|NCT00706719|141589204|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 3.||||0.006
71040428|NCT00706719|141589204|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 6.||||0.009
71040429|NCT00706719|141589204|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Follow-up (Month 7).||||0.0024
70994954|NCT03641547|141498687|OTHER||Post prob of tox at dose level 6|0.029|||||TWO_SIDED|95.0|0.0|0.165||||||The primary analysis is performed using the Time-To-Event Continual Reassessment Method (TiTE-CRM). Giving posterior estimates for the probability of toxicity (DLT) at each dose level.||0.165|0|
70994955|NCT03641547|141498688|OTHER||Post prob of tox at dose level 4|0.185|||||TWO_SIDED|95.0|0.042|0.397||||||The primary analysis is performed using the Time-To-Event Continual Reassessment Method (TiTE CRM). Giving posterior estimates for the probability of toxicity (DLT) at each dose level.||0.397|0.042|
70994956|NCT00418379|141498710|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||< 0.0001
70994957|NCT00418379|141498710|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||< 0.0001
70994958|NCT02180217|141498748|OTHER||Odds Ratio (OR)|13.71|||<|0.001|TWO_SIDED|95.0|3.73|53.44|||Cochran-Mantel-Haenszel|||||53.44|3.73|<.001
70994959|NCT02219087|141498776|SUPERIORITY_OR_OTHER|||||||0.137|||||||t-test, 2 sided|||||||0.137
70994960|NCT02219087|141498777|SUPERIORITY_OR_OTHER|||||||0.343|||||||t-test, 2 sided|||||||0.343
70994961|NCT02219087|141498778|SUPERIORITY_OR_OTHER|||||||0.208|||||||t-test, 2 sided|||||||0.208
71040430|NCT00706719|141589205|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of Group A and B observed values at Baseline.||||0.15
71099725|NCT00806026|141708507|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-17.25|STANDARD_ERROR_OF_MEAN|4.332|<|0.0001|TWO_SIDED|95.0|-25.76|-8.74||This analysis was step 7 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pregabalin 300 mg versus placebo: Mixed model analysis was used to analyze SSQ-Subjective WASO score with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||-8.74|-25.76|<0.0001
71099726|NCT00806026|141708507|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.07|STANDARD_ERROR_OF_MEAN|4.408||0.8075|TWO_SIDED|95.0|-9.73|7.58||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.25 mg versus placebo: Mixed model analysis was used to analyze SSQ-Subjective WASO score with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||7.58|-9.73|0.8075
71099727|NCT00806026|141708507|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.57|STANDARD_ERROR_OF_MEAN|4.318||0.2906|TWO_SIDED|95.0|-13.05|3.91||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.5 mg versus placebo: Mixed model analysis was used to analyze SSQ-Subjective WASO score with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||3.91|-13.05|0.2906
71099728|NCT00806026|141708513|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|3.93||0.7073|TWO_SIDED|95.0|-9.3|6.3||This analysis was step 8 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pregabalin 300 mg versus placebo: Mixed model analysis was used to analyze RLS-NDI with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||6.30|-9.30|0.7073
71099729|NCT00806026|141708513|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.4|STANDARD_ERROR_OF_MEAN|3.78||0.5299|TWO_SIDED|95.0|-5.1|9.9||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.25 mg versus placebo: Mixed model analysis was used to analyze RLS-NDI with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||9.9|-5.1|0.5299
71099730|NCT00806026|141708513|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.9|STANDARD_ERROR_OF_MEAN|3.69||0.0354|TWO_SIDED|95.0|-15.2|-0.5||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.5 mg versus placebo: Mixed model analysis was used to analyze RLS-NDI with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||-0.5|-15.2|0.0354
70994962|NCT02219087|141498779|SUPERIORITY_OR_OTHER|||||||0.385|||||||t-test, 2 sided|||||||0.385
70994963|NCT02219087|141498780|SUPERIORITY_OR_OTHER|||||||0.843|||||||Chi-squared|||||||0.843
70994964|NCT02219087|141498781|SUPERIORITY_OR_OTHER|||||||0.438|||||||Wilcoxon (Mann-Whitney)|||||||0.438
70994965|NCT01632735|141498785|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75|||<|0.05|TWO_SIDED|95.0|0.57|0.99|||GEE|Generalized Estimating Equations regression examined primary relapse (measured by urinalysis) over time by condition, controlling for age and gender.||||0.99|0.57|<0.05
71040431|NCT00706719|141589205|SUPERIORITY_OR_OTHER|||||||0.0067|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of Group A and B observed values at Month 3.||||0.0067
71040432|NCT00706719|141589205|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of Group A and B observed values at Month 6.||||0.10
71040433|NCT00706719|141589205|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Follow-up (Month 7).||||0.26
71040434|NCT00706719|141589206|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Baseline.||||0.880
71040435|NCT00706719|141589206|SUPERIORITY_OR_OTHER|||||||0.612|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 3.||||0.612
71040436|NCT00706719|141589206|SUPERIORITY_OR_OTHER|||||||0.488|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 6.||||0.488
70994966|NCT01632735|141498786|SUPERIORITY_OR_OTHER||Beta (timexcondition)|0.239|||<|0.001|TWO_SIDED|95.0|0.219|0.248|||Mixed Models Analysis|Analyses controlled for age and gender.||Mixed modeling using a repeated-measures random-effects model was conducted to test for the effects of treatment (dummy coded with 1 = mobile intervention, 0 = control) and time as well as the treatment x time interaction on the primary outcome measures of recovery behaviors mean days over time (baseline, discharge, 3, 6, and 9-month follow-ups).||0.248|0.219|<0.001
70994967|NCT01632735|141498787|SUPERIORITY_OR_OTHER||Beta (time x condition)|0.115|||<|0.001|TWO_SIDED|95.0|0.106|0.123|||Mixed Models Analysis|A repeated-measures model tested for effects of treatment vs. control on recovery self-confidence over time controlling for age and gender.||Mixed modeling using a repeated-measures random-effects model was conducted to test for the effects of treatment (dummy coded with 1 = mobile intervention, 0 = control) and time as well as the treatment x time interaction on the outcome measure of recovery confidence mean score over time.||0.123|0.106|<0.001
70994968|NCT01632735|141498788|SUPERIORITY_OR_OTHER||Beta effect (timexcondition)|0.217|||<|0.001|TWO_SIDED|95.0|0.2|0.233|||Mixed Models Analysis|Analyses controlled for age and gender.||Mixed modeling using a repeated-measures random-effects model was conducted to test for the effects of treatment (dummy coded with 1 = mobile intervention, 0 = control) and time as well as the treatment x time interaction on the outcome measure of self-help utilization (mean days in past month) over the study period (baseline, discharge, and 3-, 6-, and 9-month follow-ups).||0.233|0.2|<0.001
70994969|NCT04111107|141498863|OTHER|||||||0.966|||||||Wilcoxon signed rank (2 sided)|||H0: Progression-free ratio = 1||||0.966
70994970|NCT04111107|141498866|OTHER|Single proportion was estimated.|proportion|4.2|||||TWO_SIDED|95.0|0.1|21.1|||||exact binomial confidence interval|The proportion with a complete or partial response was estimated and an exact binomial confidence interval was calculated||21.1|0.1|
70994971|NCT03011450|141498889|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
70994972|NCT03011450|141498890|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
70994973|NCT03011450|141498891|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
70994974|NCT03011450|141498892|SUPERIORITY|||||||0.0156|||||||Hodges-Lehmann method|||||||0.0156
71040437|NCT00706719|141589206|SUPERIORITY_OR_OTHER|||||||0.054|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Follow-up (Month 7).||||0.054
70994975|NCT03011450|141498893|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
70994976|NCT03011450|141498894|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
70994977|NCT03011450|141498895|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
70994978|NCT03011450|141498896|SUPERIORITY|||||||0.0001|||||||Hodges-Lehmann method|||||||0.0001
70994979|NCT03011450|141498897|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
70994980|NCT03011450|141498898|SUPERIORITY|||||||0.538|||||||Hodges-Lehmann method|||||||0.5380
70994981|NCT03011450|141498899|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
70994982|NCT03011450|141498900|SUPERIORITY|||||||0.1165|||||||Hodges-Lehmann method|||||||0.1165
70994983|NCT03011450|141498901|SUPERIORITY|||||||0.0142|||||||Hodges-Lehmann method|||||||0.0142
70994984|NCT03011450|141498902|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
70994985|NCT03011450|141498903|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
70994986|NCT03011450|141498904|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
70994987|NCT03011450|141498905|SUPERIORITY|||||||0.4589|||||||Hodges-Lehmann method|||||||0.4589
70994988|NCT03011450|141498906|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
70994989|NCT03011450|141498907|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
70994990|NCT03011450|141498908|OTHER||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
70994991|NCT03011450|141498909|SUPERIORITY|||||||0.2486|||||||Hodges-Lehmann method|||||||0.2486
70994992|NCT03011450|141498910|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
70994993|NCT03011450|141498911|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
70994994|NCT03011450|141498912|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
70994995|NCT03011450|141498913|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
70994996|NCT03011450|141498914|SUPERIORITY|||||||0.0001|||||||Hodges-Lehmann method|||||||0.0001
70994997|NCT03011450|141498915|SUPERIORITY|||||||0.2763|||||||Hodges-Lehmann method|||||||0.2763
70994998|NCT03011450|141498916|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
70994999|NCT03011450|141498917|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
70995000|NCT03011450|141498918|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
70995001|NCT03011450|141498919|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
70995002|NCT03011450|141498920|SUPERIORITY|||||||0.1651|||||||Hodges-Lehmann method|||||||0.1651
70995003|NCT03011450|141498921|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
70995004|NCT03011450|141498922|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
70995005|NCT03011450|141498923|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
70995006|NCT03011450|141498924|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
70995007|NCT03011450|141498925|SUPERIORITY|||||||0.5107|||||||Hodges-Lehmann method|||||||0.5107
70995008|NCT03011450|141498926|SUPERIORITY||Hodges-Lehmann method|||||0.0018|||||||Hodges-Lehmann method|||||||0.0018
70995009|NCT03011450|141498927|SUPERIORITY|||||||0.0742|||||||Hodges-Lehmann method|||||||0.0742
70995010|NCT03011450|141498928|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
70995011|NCT03011450|141498929|SUPERIORITY|||||||0.2707|||||||Hodges-Lehmann method|||||||0.2707
70995012|NCT03011450|141498930|SUPERIORITY|||||||0.0009|||||||Hodges-Lehmann method|||||||0.0009
70995013|NCT03011450|141498931|SUPERIORITY|||||||0.2879|||||||Hodges-Lehmann method|||||||0.2879
70995014|NCT03011450|141498932|SUPERIORITY|||||||0.9786|||||||Hodges-Lehmann method|||||||0.9786
70995015|NCT03011450|141498933|SUPERIORITY|||||||0.0075|||||||Hodges-Lehmann method|||||||0.0075
70995016|NCT03011450|141498934|SUPERIORITY|||||||0.0241|||||||Hodges-Lehmann method|||||||0.0241
70995017|NCT03011450|141498935|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
70995018|NCT03011450|141498936|SUPERIORITY|||||||0.0502|||||||Hodges-Lehmann method|||||||0.0502
70995019|NCT03011450|141498937|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
70995020|NCT03011450|141498938|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
70995021|NCT03011450|141498939|SUPERIORITY|||||||0.0209|||||||Hodges-Lehmann method|||||||0.0209
70995022|NCT03011450|141498940|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
70995023|NCT03011450|141498941|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71040438|NCT00706719|141589207|SUPERIORITY_OR_OTHER|||||||0.705|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Baseline.||||0.705
71040439|NCT00706719|141589207|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 3.||||0.013
71040440|NCT00706719|141589207|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 6.||||0.004
71040441|NCT00706719|141589207|SUPERIORITY_OR_OTHER|||||||0.808|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Follow-up (Month 7).||||0.808
70995024|NCT03011450|141498942|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
70995025|NCT03011450|141498943|SUPERIORITY||||||<|0.0001|||||||non-parametric Hodges-Lehmann method|||||||<0.0001
70995026|NCT03011450|141498944|SUPERIORITY|||||||0.0001|||||||Hodges-Lehmann method|||||||0.0001
70995027|NCT03011450|141498945|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
70995028|NCT03519516|141499031|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.749|||||||Wilcoxon (Mann-Whitney)|||||||0.749
71099731|NCT00806026|141708515|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.28||0.0004|TWO_SIDED|95.0|-1.55|-0.45||This analysis was step 9 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pregabalin 300 mg versus placebo: Mixed model analysis was used to analyze limb pain-VAS with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||-0.45|-1.55|0.0004
71099732|NCT00806026|141708515|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.282||0.1242|TWO_SIDED|95.0|-0.99|0.12||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.25 mg versus placebo: Mixed model analysis was used to analyze limb pain-VAS with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||0.12|-0.99|0.1242
71099733|NCT00806026|141708515|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.287||0.0553|TWO_SIDED|95.0|-1.12|0.01||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.5 mg versus placebo: Mixed model analysis was used to analyze limb pain-VAS with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||0.01|-1.12|0.0553
71099734|NCT00728182|141708565|SUPERIORITY_OR_OTHER|||||||0.445||95.0|||||ANCOVA|Data were cubic root transformed and modelled with multiple linear regression.||Comparison of the summed volume of new FLAIR lesions in the NA-1 and placebo treated groups.||||0.445
71099735|NCT00728182|141708566|SUPERIORITY_OR_OTHER||Adjusted Incidence Rate Ratio|0.53||||0.018|TWO_SIDED|95.0|0.38|0.74|||Generalized linear model|With log link and negative bnomial distribution.||Comparison of the total number of new ischemic lesions on DWI for NA-1 versus placebo treated groups.||0.74|0.38|0.018
71099736|NCT00728182|141708567|SUPERIORITY_OR_OTHER||Adjusted Incidence Rate Ratio|0.59||||0.048|TWO_SIDED|95.0|0.42|0.83|||Generalized linear model|With log link and negative binomial distribution.||Comparison of the total number of new FLAIR lesions in the NA-1 versus placebo treated groups.||0.83|0.42|0.048
71099737|NCT00728182|141708568|SUPERIORITY_OR_OTHER|||||||0.306||95.0|||||ANCOVA|Data were cubic root transformed and modelled with multiple linear regresion.||Comparison of the summed volume of new ischemic lesions on DWI.||||0.306
71099738|NCT00728182|141708569|SUPERIORITY_OR_OTHER||Relative Risk|1.0||||0.43|TWO_SIDED|95.0|0.9|1.1|||Chi-squared|||Number of patients obtaining a score on the NIHSS of 0-1 at Day 30.||1.1|0.9|0.43
71099739|NCT00728182|141708570|SUPERIORITY_OR_OTHER||Relative Risk|1.0||||1|TWO_SIDED|95.0|0.9|1.1|||Chi-squared|||Comparison of the number of patients with mRS scores of 0-2 at Day 30 for NA-1 and placebo treated groups.||1.1|0.9|1.00
71099740|NCT00728182|141708571|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANCOVA|||||||0.023
71099741|NCT00728182|141708572|SUPERIORITY_OR_OTHER||Adjusted Incidence Rate Ratio|0.36||||0.027|TWO_SIDED|95.0|0.17|0.73|||Adjusted Incidence Rate Ratio|||||0.73|0.17|0.027
71099742|NCT00728182|141708573|SUPERIORITY_OR_OTHER||Adjusted Incidence Rate Ratio|0.36||||0.046|TWO_SIDED|95.0|0.17|0.75|||Generalized linear model|||||0.75|0.17|0.046
70995029|NCT03519516|141499032|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.041|||||||Chi-squared|||||||0.041
70995030|NCT03519516|141499033|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.694|||||||Wilcoxon (Mann-Whitney)|||||||0.694
70995031|NCT03519516|141499034|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.495|||||||Wilcoxon (Mann-Whitney)|||||||0.495
70995032|NCT03519516|141499035|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.492||||||statistical analysis between groups for final visit with green lissamine|Chi-squared|||||||0.492
70995033|NCT03519516|141499035|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.238||||||statistical analysis between groups for final visit with fluorescein|Chi-squared, Corrected|||||||0.238
70995034|NCT03519516|141499036|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.213|||||||Chi-squared|||||||0.213
70995035|NCT03519516|141499038|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.741|||||||Chi-squared, Corrected|||||||0.741
70995036|NCT03519516|141499040|NON_INFERIORITY|The study drug is considered non-inferior with respect to the comparator if there are no differences above twenty percent||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.110
70995037|NCT01529385|141499046|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
71099743|NCT00728182|141708574|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANCOVA|||||||0.015
71099744|NCT00728182|141708575|SUPERIORITY_OR_OTHER||Relative Risk|1.5||||0.02|TWO_SIDED|95.0|1.1|2.0|||Chi-squared|||||2.0|1.1|0.02
71099745|NCT00728182|141708576|SUPERIORITY_OR_OTHER||Relative Risk|1.3||||0.18|TWO_SIDED|95.0|0.95|1.7|||Chi-squared|||||1.7|0.95|0.18
70995038|NCT01529385|141499047|SUPERIORITY_OR_OTHER||||||<|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||<0.05
70995039|NCT01529385|141499048|SUPERIORITY_OR_OTHER||||||<|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||<.05
70995040|NCT01529385|141499049|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
70995041|NCT01529385|141499050|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
70995042|NCT01529385|141499051|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
70995043|NCT01529385|141499053|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
70995044|NCT01529385|141499054|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
70995045|NCT01529385|141499055|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
70995046|NCT00321269|141499056|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Mixed Models Analysis|||Mixed effects regression analysis- Treatment Arm X Time F (2, 116)=0.09, P\>F=0.90.||||0.90
70995047|NCT00321269|141499057|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Mixed Models Analysis|F(2,110)=2.08; P=0.13||||||0.13
70995048|NCT04009213|141499090|NON_INFERIORITY|H0: δT - δC ≥ 0.9 Ha: δT - δC \< 0.9|||||<|0.025|ONE_SIDED|95.0|||||ANCOVA|||||||< 0.025
70995049|NCT04009213|141499091|NON_INFERIORITY|H0: qT - qC ≥ 10% H1: qT - qC \< 10%|||||<|0.025|ONE_SIDED|95.0|||||Farrington-Manning|||||||< 0.025
70995050|NCT04009213|141499092|NON_INFERIORITY|H0: pC - pT ≥ 10% H1: pC - pT \< 10%,|||||<|0.025|ONE_SIDED|95.0|||||Farrington-Manning|||||||<0.025
70995051|NCT04009213|141499093|NON_INFERIORITY|H0: πC - πT ≥ 15% H1: πC - πT \< 15%,|||||<|0.025|ONE_SIDED|95.0|||||Farrington-Manning|||||||< 0.025
70995052|NCT01709981|141499102|EQUIVALENCE|Mann-Whitney||||||0.31|||||||Wilcoxon (Mann-Whitney)|2-sided||||||0.31
70995053|NCT01763866|141499107|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-71.42|STANDARD_ERROR_OF_MEAN|3.11|<|0.001|TWO_SIDED|95.0|-77.55|-65.29||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-65.29|-77.55|<0.001
70995054|NCT01763866|141499107|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.16|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-65.94|-52.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-52.38|-65.94|<0.001
70995055|NCT01763866|141499107|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.6|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-45.81|-33.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-33.40|-45.81|<0.001
70995056|NCT01763866|141499107|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.1|STANDARD_ERROR_OF_MEAN|3.41|<|0.001|TWO_SIDED|95.0|-47.83|-34.37||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-34.37|-47.83|<0.001
70995057|NCT01763866|141499107|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-76.29|STANDARD_ERROR_OF_MEAN|5.36|<|0.001|TWO_SIDED|95.0|-86.87|-65.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-65.72|-86.87|<0.001
70995058|NCT01763866|141499107|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-70.51|STANDARD_ERROR_OF_MEAN|4.72|<|0.001|TWO_SIDED|95.0|-79.81|-61.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-61.20|-79.81|<0.001
70995059|NCT01763866|141499107|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.2|STANDARD_ERROR_OF_MEAN|5.24|<|0.001|TWO_SIDED|95.0|-57.54|-36.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-36.86|-57.54|<0.001
70995060|NCT01763866|141499107|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.88|STANDARD_ERROR_OF_MEAN|4.73|<|0.001|TWO_SIDED|95.0|-48.21|-29.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-29.56|-48.21|<0.001
71040442|NCT00706719|141589208|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Baseline.||||0.008
71040443|NCT00706719|141589208|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 3.||||0.015
71040444|NCT00706719|141589208|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 6.||||0.003
71040445|NCT00706719|141589208|SUPERIORITY_OR_OTHER|||||||0.109|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Follow-up (Month 7).||||0.109
71040446|NCT02951195|141589223|SUPERIORITY||LS Mean Difference|6.4||||0.0207|TWO_SIDED|95.0|0.3|12.6|||Mixed-effects Model for Repeated Measure|||||12.6|0.3|0.0207
71040447|NCT02951195|141589223|SUPERIORITY||LS Mean Difference|10.5||||0.0002|TWO_SIDED|95.0|5.0|15.9|||Mixed-effects Model for Repeated Measure|||||15.9|5.0|0.0002
71040448|NCT02951195|141589223|SUPERIORITY||LS Mean Difference|8.8||||0.0019|TWO_SIDED|95.0|3.0|14.5|||Mixed-effects Model for Repeated Measure|||||14.5|3.0|0.0019
71040449|NCT02951195|141589223|SUPERIORITY||LS Mean Difference|8.3||||0.054|TWO_SIDED|95.0|-2.1|18.7|||Mixed-effects Model for Repeated Measure|||||18.7|-2.1|0.0540
71040450|NCT02951195|141589224|SUPERIORITY||LS Mean Difference|8.7||||0.0007|TWO_SIDED|95.0|3.7|13.8|||Mixed-effects Model for Repeated Measure|||||13.8|3.7|0.0007
71040451|NCT02951195|141589225|SUPERIORITY||Least Squares (LS) Mean Difference|-19.5||||0.0018|TWO_SIDED|95.0|-32.2|-6.8|||Mixed-effects Model for Repeated Measure|||||-6.8|-32.2|0.0018
71040452|NCT02951195|141589225|SUPERIORITY||LS Mean Difference|-13.6||||0.0106|TWO_SIDED|95.0|-25.0|-2.1|||Mixed-effects Model for Repeated Measure|||||-2.1|-25.0|0.0106
71040453|NCT02951195|141589225|SUPERIORITY||LS Mean Difference|-27.5|||<|0.0001|TWO_SIDED|95.0|-38.6|-16.3|||Mixed-effects Model for Repeated Measure|||||-16.3|-38.6|<0.0001
71040454|NCT02951195|141589225|SUPERIORITY||LS Mean Difference|-24.8||||0.0017|TWO_SIDED|95.0|-40.0|-9.7|||Mixed-effects Model for Repeated Measure|||||-9.7|-40.0|0.0017
71040455|NCT02951195|141589226|SUPERIORITY||LS Mean Difference|-23.9|||<|0.0001|TWO_SIDED|95.0|-33.7|-14.1|||Mixed-effects Model for Repeated Measure|||||-14.1|-33.7|<0.0001
71040456|NCT02951195|141589227|SUPERIORITY||LS Mean Difference|12.5||||0.0166|TWO_SIDED|95.0|1.1|24.0|||Mixed-effects Model for Repeated Measure|||||24.0|1.1|0.0166
71040457|NCT02951195|141589227|SUPERIORITY||LS Mean Difference|21.3|||<|0.0001|TWO_SIDED|95.0|11.2|31.4|||Mixed-effects Model for Repeated Measure|||||31.4|11.2|<0.0001
71040458|NCT02951195|141589227|SUPERIORITY||LS Mean Difference|17.1||||0.0013|TWO_SIDED|95.0|6.3|27.8|||Mixed-effects Model for Repeated Measure|||||27.8|6.3|0.0013
71040459|NCT02951195|141589227|SUPERIORITY||LS Mean Difference|14.5||||0.0563|TWO_SIDED|95.0|-3.8|32.9|||Mixed-effects Model for Repeated Measure|||||32.9|-3.8|0.0563
71040460|NCT02951195|141589228|SUPERIORITY||LS Mean Difference|13.6||||0.0012|TWO_SIDED|95.0|5.3|21.9|||Mixed-effects Model for Repeated Measure|||||21.9|5.3|0.0012
71040461|NCT02951195|141589229|SUPERIORITY||LS Mean Difference|14.1||||0.0476|TWO_SIDED|95.0|-2.6|30.9|||ANCOVA|||||30.9|-2.6|0.0476
71040462|NCT02951195|141589229|SUPERIORITY||LS Mean Difference|29.4||||0.0001|TWO_SIDED|95.0|14.8|44.0|||ANCOVA|||||44.0|14.8|0.0001
71040463|NCT02951195|141589229|SUPERIORITY||LS Mean Difference|26.2||||0.0006|TWO_SIDED|95.0|11.3|41.1|||ANCOVA|||||41.1|11.3|0.0006
71040464|NCT02951195|141589229|SUPERIORITY||LS Mean Difference|4.8||||0.2714|TWO_SIDED|95.0|-11.6|21.2|||Mixed-effects Model for Repeated Measure|||||21.2|-11.6|0.2714
71040465|NCT02951195|141589230|SUPERIORITY||LS Mean Difference|11.3||||0.0138|TWO_SIDED|95.0|1.3|21.2|||Mixed-effects Model for Repeated Measure|||||21.2|1.3|0.0138
71040466|NCT04633642|141589261|SUPERIORITY||Mean Difference (Final Values)|1.05|STANDARD_DEVIATION|0.74|<|0.01|TWO_SIDED|||||The threshold for statistical significances was p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.01
71040467|NCT04633642|141589262|SUPERIORITY||Mean Difference (Final Values)|1.61|STANDARD_DEVIATION|0.17|<|0.01|TWO_SIDED|||||The threshold for statistical significance was p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.01
71040468|NCT04633642|141589263|SUPERIORITY||Mean Difference (Final Values)|0.56|STANDARD_DEVIATION|0.79|<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71040469|NCT04633642|141589264|SUPERIORITY||Mean Difference (Final Values)|-2.28|STANDARD_DEVIATION|0.44||0.01|TWO_SIDED|||||The threshold for statistical significance was p\<0.05|t-test, 2 sided|||We analyzed 51 patients (24 in surgical group and 27 in UAW group) with a statistical power of 0.80 and an alpha of 0.05, with a power of the clinical di↵erence of 37% to detect a statistically significant between groups.||||0.01
71040470|NCT04633642|141589265|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.93|TWO_SIDED|||||The threshold for statistics significance was p\<0.05|t-test, 2 sided|||||||0.93
71040471|NCT04633642|141589266|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|0.18||0.711|TWO_SIDED||||||t-test, 2 sided|||We analyzed 51 patients (24 in surgical group and 27 in UAW group) with a statistical power of 0.80 and an alpha of 0.05, with a power of the clinical difference of 37% to detect a statistically significant between groups.||||0.711
71040472|NCT01405469|141589295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.44|STANDARD_DEVIATION|2.66|<|0.001||95.0|||||t-test, 2 sided|||this pilot study was created ro evaluate sample size for the following multicenter study, based on manometric outcomes. Mean values between baseline and follow-up were compared using Student ' s t -test for paired samples. P values less then 0.05, two-sided, were considered significant.R 2.13.1(R Development Core Team (2011). Subgroups (partial vs. complete myotomy) were compared using an analysis of variance test adjusted for initial values.||||<0.001
71040473|NCT00974350|141589314|SUPERIORITY||LS Mean Difference|-1.14|STANDARD_ERROR_OF_MEAN|0.353||0.0031|TWO_SIDED|95.0|-1.84|-0.44|||ANOVA|LS Mean difference from SABER-Placebo||Pain Intensity on Movement AUCs1-72 hours Including Pain Assessed Upon Taking Opioid Rescue - ITT||-0.44|-1.84|0.0031
71040474|NCT00974350|141589315|SUPERIORITY|||||||0.0909|||||||Cochran-Mantel-Haenszel|Stratified by pooled study sites||Proportion of Patients Not Taking Any Supplemental Opioid Analgesic Medication||||0.0909
70995061|NCT01763866|141499107|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-68.21|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-74.72|-61.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-61.70|-74.72|<0.001
70995062|NCT01763866|141499107|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-64.49|STANDARD_ERROR_OF_MEAN|3.21|<|0.001|TWO_SIDED|95.0|-70.84|-58.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-58.14|-70.84|<0.001
70995063|NCT01763866|141499107|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-68.31|STANDARD_ERROR_OF_MEAN|4.42|<|0.001|TWO_SIDED|95.0|-77.04|-59.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-59.57|-77.04|<0.001
70995064|NCT01763866|141499107|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.98|STANDARD_ERROR_OF_MEAN|5.23|<|0.001|TWO_SIDED|95.0|-65.31|-44.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-44.65|-65.31|<0.001
70995065|NCT01763866|141499107|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-70.56|STANDARD_ERROR_OF_MEAN|3.12|<|0.001|TWO_SIDED|95.0|-76.72|-64.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-64.41|-76.72|<0.001
70995066|NCT01763866|141499107|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.41|STANDARD_ERROR_OF_MEAN|4.41|<|0.001|TWO_SIDED|95.0|-69.11|-51.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-51.72|-69.11|<0.001
70995067|NCT01763866|141499108|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-69.95|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-75.38|-64.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-64.51|-75.38|<0.001
70995068|NCT01763866|141499108|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-62.82|STANDARD_ERROR_OF_MEAN|3.17|<|0.001|TWO_SIDED|95.0|-69.06|-56.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-56.57|-69.06|<0.001
71040475|NCT01344018|141589320|SUPERIORITY|"Time assessment biases were taken into account for the primary endpoint:~* Surgery alone arm: abdominal recurrence occurring prior to week 14 assessment was counted as occurring at week 14; progression occurring after the week 14 was counted as occurring at week 24.~* Preoperative RT arm: abdominal recurrence occurring was counted as occurring at week 14; and any abdominal recurrence occurring after and prior to or during the week 24 will be counted as occurring at week 24."|Hazard Ratio (HR)|1.01||||0.955|TWO_SIDED|95.0|0.71|1.44||A 5% significance level was considered as a threshold for statistical significance.|Regression, Cox|The time assessment biases correction described before was not applied to patients for whom death was the first event.|The arm having surgery alone was the reference arm.|Sample size was determined to provide 90% power for detecting a Hazard Ratio (HR)=0.52 (which corresponds to a 20% difference in ARFS rate at 5 years, from 50% in the surgery arm to 70% in the experimental arm) at a global 2-sided 5% significance level assuming ARFS followed an exponential distribution in both arms. This test required 102 events at the time of the statistical analysis.||1.44|0.71|0.955
71040476|NCT01344018|141589325|SUPERIORITY|ARFI was described using cumulative incidence curves. ARFI was compared between the two treatment arms using a Fine and Gray model.|Hazard Ratio (HR)|1.09||||0.658|TWO_SIDED|95.0|0.74|1.6||A 5% significance level was considered as a threshold for statistical significance.|Fine and Gray model|||||1.60|0.74|0.658
71040477|NCT01344018|141589326|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.595|TWO_SIDED|95.0|0.58|1.36||A 5% significance level was considered as a threshold for statistical significance.|Regression, Cox|||||1.36|0.58|0.595
71040478|NCT01344018|141589327|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.615|TWO_SIDED|95.0|0.65|2.05|||Regression, Cox|||||2.05|0.65|0.615
71040479|NCT05070754|141589328|SUPERIORITY|||||||0.534|||||||Chi-squared|||Outcome measures 1-3 were all tested together. Null hypothesis was that there was no difference in the degree of lesion resolution between the two treatment methods.||||0.534
71040480|NCT05070754|141589329|SUPERIORITY|||||||0.534|||||||Chi-squared|||Outcome measures 1-3 were all tested together. Null hypothesis was that there was no difference in the degree of lesion resolution between the two treatment methods.||||0.534
71040481|NCT05070754|141589330|SUPERIORITY|||||||0.534|||||||Chi-squared|||Outcome measures 1-3 were all tested together. Null hypothesis was that there was no difference in the degree of lesion resolution between the two treatment methods.||||0.534
71040482|NCT05070754|141589331|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71040483|NCT05070754|141589332|SUPERIORITY|||||||0.142|||||||Wilcoxon Signed Rank Test|||Null hypothesis: there was no difference in median pain levels between SOC and NTAP treated lesions.||||0.142
71040484|NCT04561115|141589339|EQUIVALENCE|The relative alpha level for statistical significance was 0.1 (alpha=0.05 for one-sided test), or a 90% CI was used for the bioequivalence test.|Geometric Least Square Mean Ratio|0.948|||||TWO_SIDED|90.0|0.926|0.972||||||||0.972|0.926|
70995069|NCT01763866|141499108|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.53|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-43.03|-32.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-32.03|-43.03|<0.001
71040485|NCT04561115|141589340|EQUIVALENCE|The relative alpha level for statistical significance was 0.1 (alpha=0.05 for one-sided test), or a 90% CI was used for the bioequivalence test.|Geometric Least Square Mean Ratio|0.978|||||TWO_SIDED|90.0|0.937|1.021||||||||1.021|0.937|
71040486|NCT03480022|141589373|SUPERIORITY||||||<|0.002|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.002
70995070|NCT01763866|141499108|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.49|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-49.7|-37.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-37.28|-49.70|<0.001
70995071|NCT01763866|141499108|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-74.92|STANDARD_ERROR_OF_MEAN|4.85|<|0.001|TWO_SIDED|95.0|-84.49|-65.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-65.35|-84.49|<0.001
70995072|NCT01763866|141499108|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-74.81|STANDARD_ERROR_OF_MEAN|4.15|<|0.001|TWO_SIDED|95.0|-83.0|-66.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-66.62|-83.00|<0.001
70995073|NCT01763866|141499108|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.95|STANDARD_ERROR_OF_MEAN|4.75|<|0.001|TWO_SIDED|95.0|-54.32|-35.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-35.57|-54.32|<0.001
70995074|NCT01763866|141499108|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.81|STANDARD_ERROR_OF_MEAN|4.19|<|0.001|TWO_SIDED|95.0|-52.06|-35.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-35.55|-52.06|<0.001
70995075|NCT01763866|141499108|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-66.88|STANDARD_ERROR_OF_MEAN|2.93|<|0.001|TWO_SIDED|95.0|-72.67|-61.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-61.08|-72.67|<0.001
70995076|NCT01763866|141499108|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-66.58|STANDARD_ERROR_OF_MEAN|3.05|<|0.001|TWO_SIDED|95.0|-72.6|-60.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-60.56|-72.60|<0.001
70995077|NCT01763866|141499108|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-65.66|STANDARD_ERROR_OF_MEAN|3.81|<|0.001|TWO_SIDED|95.0|-73.19|-58.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-58.12|-73.19|<0.001
70995078|NCT01763866|141499108|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-62.91|STANDARD_ERROR_OF_MEAN|4.27|<|0.001|TWO_SIDED|95.0|-71.37|-54.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-54.46|-71.37|<0.001
70995079|NCT01763866|141499108|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-69.43|STANDARD_ERROR_OF_MEAN|2.74|<|0.001|TWO_SIDED|95.0|-74.86|-64.01||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-64.01|-74.86|<0.001
70995080|NCT01763866|141499108|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-68.45|STANDARD_ERROR_OF_MEAN|4.17|<|0.001|TWO_SIDED|95.0|-76.68|-60.22||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-60.22|-76.68|<0.001
70995081|NCT01763866|141499109|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-83.6|STANDARD_ERROR_OF_MEAN|4.5|<|0.001|TWO_SIDED|95.0|-92.6|-74.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-74.6|-92.6|<0.001
70995082|NCT01763866|141499109|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-79.7|STANDARD_ERROR_OF_MEAN|5.3|<|0.001|TWO_SIDED|95.0|-90.2|-69.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-69.2|-90.2|<0.001
70995083|NCT01763866|141499109|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.4|STANDARD_ERROR_OF_MEAN|4.4|<|0.001|TWO_SIDED|95.0|-53.4|-35.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-35.3|-53.4|<0.001
70995084|NCT01763866|141499109|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.0|STANDARD_ERROR_OF_MEAN|5.3|<|0.001|TWO_SIDED|95.0|-65.4|-44.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-44.6|-65.4|<0.001
70995085|NCT01763866|141499109|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-69.9|STANDARD_ERROR_OF_MEAN|6.1|<|0.001|TWO_SIDED|95.0|-81.9|-57.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-57.8|-81.9|<0.001
71040487|NCT03480022|141589374|SUPERIORITY||||||<|0.006|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.006
71040488|NCT03480022|141589375|SUPERIORITY||||||<|0.001|||||||ANOVA|Repeated measures nested design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.001
71040489|NCT03480022|141589376|SUPERIORITY||||||<|0.002|||||||ANOVA|one-way ANOVA||||||<0.002
71040490|NCT03480022|141589377|SUPERIORITY||||||<|0.007|||||||Wilcoxon (Mann-Whitney)|||||||<0.007
71040491|NCT03480022|141589378|SUPERIORITY||||||<|0.049|||||||Wilcoxon (Mann-Whitney)|||||||<0.049
71040492|NCT03480022|141589379|SUPERIORITY||||||<|0.011|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.011
71040493|NCT03480022|141589380|SUPERIORITY||||||<|0.038|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.038
71040494|NCT03480022|141589381|SUPERIORITY||||||<|0.048|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.048
71040495|NCT03480022|141589382|SUPERIORITY||||||<|0.018|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.018
71040496|NCT03480022|141589383|SUPERIORITY||||||<|0.028|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.028
71040497|NCT03480022|141589384|SUPERIORITY||||||<|0.034|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.034
71040498|NCT03480022|141589385|SUPERIORITY||||||<|0.035|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.035
71099746|NCT01898091|141708578|SUPERIORITY_OR_OTHER|||||||0.84|||||||Wilcoxin rank sum test|||Simulations determined power to detect significant difference defined as a mean difference of 1 unit (MTS scale). Feasibility study provided proportion of patients in control and neem group with change scores of 0, 1, 2, 3, and 4 as (5%, 10%, 10%, 45% and 30%) and (15%, 20%, 30%, 25% and 10%), respectively. Simulated 10,000 trials using multinomial distributions by the percentages above, with 20 patients per group, provided 80% power to detect 0.9 unit difference using a one-sided alpha of 0.05.||||0.84
70995086|NCT01763866|141499109|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-65.6|STANDARD_ERROR_OF_MEAN|4.5|<|0.001|TWO_SIDED|95.0|-74.5|-56.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-56.7|-74.5|<0.001
70995087|NCT01763866|141499109|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.8|STANDARD_ERROR_OF_MEAN|6.0|<|0.001|TWO_SIDED|95.0|-57.7|-33.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-33.9|-57.7|<0.001
70995088|NCT01763866|141499109|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.8|STANDARD_ERROR_OF_MEAN|4.5|<|0.001|TWO_SIDED|95.0|-47.8|-29.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.9|-47.8|<0.001
70995089|NCT01763866|141499109|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-75.4|STANDARD_ERROR_OF_MEAN|4.3|<|0.001|TWO_SIDED|95.0|-83.9|-67.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-67.0|-83.9|<0.001
70995090|NCT01763866|141499109|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-77.9|STANDARD_ERROR_OF_MEAN|5.1|<|0.001|TWO_SIDED|95.0|-88.0|-67.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-67.8|-88.0|<0.001
70995091|NCT01763866|141499109|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.8|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-63.1|-48.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-48.4|-63.1|<0.001
70995092|NCT01763866|141499109|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.6|STANDARD_ERROR_OF_MEAN|5.1|<|0.001|TWO_SIDED|95.0|-60.6|-40.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-40.6|-60.6|<0.001
70995093|NCT01763866|141499109|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-78.1|STANDARD_ERROR_OF_MEAN|4.1|<|0.001|TWO_SIDED|95.0|-86.2|-70.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-70.0|-86.2|<0.001
70995094|NCT01763866|141499109|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-80.1|STANDARD_ERROR_OF_MEAN|5.8|<|0.001|TWO_SIDED|95.0|-91.7|-68.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-68.6|-91.7|<0.001
70995095|NCT01763866|141499110|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-85.5|STANDARD_ERROR_OF_MEAN|4.9|<|0.001|TWO_SIDED|95.0|-95.2|-75.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-75.9|-95.2|<0.001
70995096|NCT01763866|141499110|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-75.8|STANDARD_ERROR_OF_MEAN|5.5|<|0.001|TWO_SIDED|95.0|-86.8|-64.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-64.9|-86.8|<0.001
71099747|NCT03782103|141708601|NON_INFERIORITY|Investigational product upper bounds must be less than 0.5.|Median Difference (Final Values)|-0.2845|||||TWO_SIDED|95.0|-0.6033|0.0334||||||Groin 30 seconds post product application, Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and the predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||0.0334|-0.6033|
71099748|NCT03782103|141708601|SUPERIORITY|Investigational product lower bounds must be greater than 1.2.|Mean Difference (Final Values)|2.8535|||||TWO_SIDED|95.0|2.5415|3.1655||||||Groin 30 seconds post product application, Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||3.1655|2.5415|
71099749|NCT03782103|141708602|NON_INFERIORITY|Investigational product average treatment effect upper bounds cannot be more than 0.5.|Mean Difference (Final Values)|0.0577|||||TWO_SIDED|95.0|-0.1457|0.2611||||||Abdomen 30 seconds post product application, Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||0.2611|-0.1457|
70995097|NCT01763866|141499110|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.8|STANDARD_ERROR_OF_MEAN|4.9|<|0.001|TWO_SIDED|95.0|-56.6|-37.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-37.1|-56.6|<0.001
70995098|NCT01763866|141499110|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-51.7|STANDARD_ERROR_OF_MEAN|5.5|<|0.001|TWO_SIDED|95.0|-62.6|-40.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-40.9|-62.6|<0.001
70995099|NCT01763866|141499110|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-71.7|STANDARD_ERROR_OF_MEAN|6.4|<|0.001|TWO_SIDED|95.0|-84.4|-59.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-59.0|-84.4|<0.001
70995100|NCT01763866|141499110|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.8|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-71.6|-52.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-52.0|-71.6|<0.001
70995101|NCT01763866|141499110|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-49.0|STANDARD_ERROR_OF_MEAN|6.3|<|0.001|TWO_SIDED|95.0|-61.5|-36.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-36.6|-61.5|<0.001
70995102|NCT01763866|141499110|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.3|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-45.2|-25.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-25.5|-45.2|<0.001
71040499|NCT03480022|141589386|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.0001
71040500|NCT03480022|141589387|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||>0.05
71040501|NCT03480022|141589388|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||>0.05
71040502|NCT03480022|141589389|SUPERIORITY||||||<|0.021|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.021
71040503|NCT03480022|141589390|SUPERIORITY||||||<|0.009|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.009
71040504|NCT03480022|141589391|SUPERIORITY||||||<|0.035|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.035
71040505|NCT03480022|141589392|SUPERIORITY||||||<|0.028|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.028
70995103|NCT01763866|141499110|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-77.1|STANDARD_ERROR_OF_MEAN|4.6|<|0.001|TWO_SIDED|95.0|-86.2|-67.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-67.9|-86.2|<0.001
70995104|NCT01763866|141499110|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-75.8|STANDARD_ERROR_OF_MEAN|5.3|<|0.001|TWO_SIDED|95.0|-86.3|-65.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-65.3|-86.3|<0.001
71040506|NCT03480022|141589393|SUPERIORITY||||||<|0.042|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.042
71040507|NCT03480022|141589394|SUPERIORITY||||||<|0.033|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.033
71040508|NCT03480022|141589395|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||>0.05
71040509|NCT03480022|141589396|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||>0.05
71040510|NCT03480022|141589397|SUPERIORITY||||||<|0.016|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.016
70995105|NCT01763866|141499110|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.2|STANDARD_ERROR_OF_MEAN|4.0|<|0.001|TWO_SIDED|95.0|-65.1|-49.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-49.4|-65.1|<0.001
70995106|NCT01763866|141499110|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.6|STANDARD_ERROR_OF_MEAN|5.7|<|0.001|TWO_SIDED|95.0|-55.9|-33.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-33.4|-55.9|<0.001
70995107|NCT01763866|141499110|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-79.0|STANDARD_ERROR_OF_MEAN|4.3|<|0.001|TWO_SIDED|95.0|-87.5|-70.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-70.4|-87.5|<0.001
71040511|NCT03480022|141589398|SUPERIORITY||||||<|0.028|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.028
71040512|NCT03480022|141589399|SUPERIORITY||||||<|0.01|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.01
70995108|NCT01763866|141499110|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-71.9|STANDARD_ERROR_OF_MEAN|6.0|<|0.001|TWO_SIDED|95.0|-83.8|-60.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-60.0|-83.8|<0.001
70995109|NCT01763866|141499111|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.28|STANDARD_ERROR_OF_MEAN|2.54|<|0.001|TWO_SIDED|95.0|-65.29|-55.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-55.27|-65.29|<0.001
70995110|NCT01763866|141499111|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.37|STANDARD_ERROR_OF_MEAN|2.97|<|0.001|TWO_SIDED|95.0|-63.23|-51.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.51|-63.23|<0.001
70995111|NCT01763866|141499111|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.77|STANDARD_ERROR_OF_MEAN|2.57|<|0.001|TWO_SIDED|95.0|-37.84|-27.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-27.70|-37.84|<0.001
70995112|NCT01763866|141499111|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.53|STANDARD_ERROR_OF_MEAN|2.95|<|0.001|TWO_SIDED|95.0|-45.34|-33.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-33.71|-45.34|<0.001
70995113|NCT01763866|141499111|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-65.17|STANDARD_ERROR_OF_MEAN|4.37|<|0.001|TWO_SIDED|95.0|-73.78|-56.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-56.56|-73.78|<0.001
70995114|NCT01763866|141499111|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-64.76|STANDARD_ERROR_OF_MEAN|3.84|<|0.001|TWO_SIDED|95.0|-72.32|-57.19||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-57.19|-72.32|<0.001
70995115|NCT01763866|141499111|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.25|STANDARD_ERROR_OF_MEAN|4.28|<|0.001|TWO_SIDED|95.0|-46.68|-29.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.81|-46.68|<0.001
70995116|NCT01763866|141499111|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.52|STANDARD_ERROR_OF_MEAN|3.87|<|0.001|TWO_SIDED|95.0|-45.15|-29.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.90|-45.15|<0.001
70995117|NCT01763866|141499111|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.61|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-64.73|-54.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-54.48|-64.73|<0.001
70995118|NCT01763866|141499111|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.2|STANDARD_ERROR_OF_MEAN|2.83|<|0.001|TWO_SIDED|95.0|-64.8|-53.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-53.60|-64.80|<0.001
70995119|NCT01763866|141499111|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-58.27|STANDARD_ERROR_OF_MEAN|3.2|<|0.001|TWO_SIDED|95.0|-64.6|-51.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.94|-64.60|<0.001
70995120|NCT01763866|141499111|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.31|STANDARD_ERROR_OF_MEAN|3.53|<|0.001|TWO_SIDED|95.0|-64.29|-50.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-50.32|-64.29|<0.001
71040513|NCT03480022|141589400|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||>0.05
71040514|NCT03480022|141589401|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||>0.05
71040515|NCT00283842|141589402|SUPERIORITY_OR_OTHER|||||||0.084|||||||Hochberg|||Statistical analysis provided for 50mg.||||0.084
70995121|NCT01763866|141499111|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.06|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|-65.18|-54.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-54.94|-65.18|<0.001
70995122|NCT01763866|141499111|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-62.82|STANDARD_ERROR_OF_MEAN|3.75|<|0.001|TWO_SIDED|95.0|-70.22|-55.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-55.42|-70.22|<0.001
70995123|NCT01763866|141499112|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.64|STANDARD_ERROR_OF_MEAN|2.84|<|0.001|TWO_SIDED|95.0|-67.25|-56.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-56.03|-67.25|<0.001
70995124|NCT01763866|141499112|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.93|STANDARD_ERROR_OF_MEAN|3.28|<|0.001|TWO_SIDED|95.0|-61.4|-48.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-48.46|-61.40|<0.001
70995125|NCT01763866|141499112|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.11|STANDARD_ERROR_OF_MEAN|2.88|<|0.001|TWO_SIDED|95.0|-40.79|-29.44||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.44|-40.79|<0.001
70995126|NCT01763866|141499112|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.72|STANDARD_ERROR_OF_MEAN|3.26|<|0.001|TWO_SIDED|95.0|-44.15|-31.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-31.30|-44.15|<0.001
70995127|NCT01763866|141499112|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-66.64|STANDARD_ERROR_OF_MEAN|4.69|<|0.001|TWO_SIDED|95.0|-75.88|-57.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-57.39|-75.88|<0.001
70995128|NCT01763866|141499112|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.01|STANDARD_ERROR_OF_MEAN|4.3|<|0.001|TWO_SIDED|95.0|-68.49|-51.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.52|-68.49|<0.001
70995129|NCT01763866|141499112|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.51|STANDARD_ERROR_OF_MEAN|4.59|<|0.001|TWO_SIDED|95.0|-49.55|-31.47||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-31.47|-49.55|<0.001
70995130|NCT01763866|141499112|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.79|STANDARD_ERROR_OF_MEAN|4.32|<|0.001|TWO_SIDED|95.0|-41.3|-24.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-24.28|-41.30|<0.001
70995131|NCT01763866|141499112|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.96|STANDARD_ERROR_OF_MEAN|2.95|<|0.001|TWO_SIDED|95.0|-65.78|-54.13||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-54.13|-65.78|<0.001
70995132|NCT01763866|141499112|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.42|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|-63.27|-51.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.57|-63.27|<0.001
70995133|NCT01763866|141499112|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.58|STANDARD_ERROR_OF_MEAN|3.73|<|0.001|TWO_SIDED|95.0|-66.95|-52.21||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-52.21|-66.95|<0.001
70995134|NCT01763866|141499112|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-49.76|STANDARD_ERROR_OF_MEAN|4.3|<|0.001|TWO_SIDED|95.0|-58.26|-41.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-41.27|-58.26|<0.001
70995135|NCT01763866|141499112|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.91|STANDARD_ERROR_OF_MEAN|2.87|<|0.001|TWO_SIDED|95.0|-66.57|-55.24||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-55.24|-66.57|<0.001
70995136|NCT01763866|141499112|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.63|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-64.63|-48.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-48.62|-64.63|<0.001
70995137|NCT01763866|141499113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-58.49|STANDARD_ERROR_OF_MEAN|2.34|<|0.001|TWO_SIDED|95.0|-63.1|-53.89||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-53.89|-63.10|<0.001
70995138|NCT01763866|141499113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.25|STANDARD_ERROR_OF_MEAN|2.66|<|0.001|TWO_SIDED|95.0|-57.49|-47.01||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-47.01|-57.49|<0.001
70995139|NCT01763866|141499113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.66|STANDARD_ERROR_OF_MEAN|2.37|<|0.001|TWO_SIDED|95.0|-38.33|-28.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-28.98|-38.33|<0.001
70995140|NCT01763866|141499113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.01|STANDARD_ERROR_OF_MEAN|2.67|<|0.001|TWO_SIDED|95.0|-45.27|-34.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-34.74|-45.27|<0.001
70995141|NCT01763866|141499113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.34|STANDARD_ERROR_OF_MEAN|3.69|<|0.001|TWO_SIDED|95.0|-66.61|-52.07||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-52.07|-66.61|<0.001
70995142|NCT01763866|141499113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-58.74|STANDARD_ERROR_OF_MEAN|3.46|<|0.001|TWO_SIDED|95.0|-65.56|-51.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.93|-65.56|<0.001
70995143|NCT01763866|141499113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.92|STANDARD_ERROR_OF_MEAN|3.64|<|0.001|TWO_SIDED|95.0|-42.09|-27.75||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-27.75|-42.09|<0.001
70995144|NCT01763866|141499113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.64|STANDARD_ERROR_OF_MEAN|3.52|<|0.001|TWO_SIDED|95.0|-46.57|-32.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-32.71|-46.57|<0.001
70995145|NCT01763866|141499113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.86|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-59.66|-50.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-50.05|-59.66|<0.001
70995146|NCT01763866|141499113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.14|STANDARD_ERROR_OF_MEAN|2.29|<|0.001|TWO_SIDED|95.0|-60.66|-51.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.61|-60.66|<0.001
70995147|NCT01763866|141499113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.78|STANDARD_ERROR_OF_MEAN|3.01|<|0.001|TWO_SIDED|95.0|-56.72|-44.83||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-44.83|-56.72|<0.001
71040516|NCT00283842|141589402|SUPERIORITY_OR_OTHER|||||||0.084|||||||Hochberg|||Statistical analysis provided for 100mg.||||0.084
71040517|NCT00283842|141589402|SUPERIORITY_OR_OTHER|||||||0.001|||||||Hochberg|||Statistical analysis provided for 200mg.||||0.001
71040518|NCT00283842|141589402|SUPERIORITY_OR_OTHER|||||||0.027|||||||Hochberg|||Statistical analysis provided for 400mg.||||0.027
71040519|NCT00283842|141589403|SUPERIORITY_OR_OTHER|||||||0.375|||||||Hochberg|||Statistical analysis provided for 50mg.||||0.375
71040520|NCT00283842|141589403|SUPERIORITY_OR_OTHER|||||||0.342|||||||Hochberg|||Statistical analysis provided for 100mg.||||0.342
71040521|NCT00283842|141589403|SUPERIORITY_OR_OTHER|||||||0.342|||||||Hochberg|||Statistical analysis provided for 200mg.||||0.342
71040522|NCT00283842|141589403|SUPERIORITY_OR_OTHER|||||||0.375|||||||Hochberg|||Statistical analysis provided for 400mg.||||0.375
71040523|NCT05068661|141589404|SUPERIORITY||Risk Ratio (RR)|0.75||||0.486|TWO_SIDED|95.0|0.4|1.39|||Chi-squared|||||1.39|0.40|0.486
71040524|NCT05068661|141589405|SUPERIORITY||Risk Ratio (RR)|0.85||||0.148|TWO_SIDED|95.0|0.69|1.06||This is adjusted P value for hypotension|Chi-squared|||||1.06|0.69|0.148
71040525|NCT05068661|141589406|SUPERIORITY||Risk Ratio (RR)|1.04|||>|0.999|TWO_SIDED|95.0|0.98|1.1||This is adjusted P value|Chi-squared|||||1.10|0.98|>0.999
70995148|NCT01763866|141499113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.94|STANDARD_ERROR_OF_MEAN|3.12|<|0.001|TWO_SIDED|95.0|-61.11|-48.76||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-48.76|-61.11|<0.001
70995149|NCT01763866|141499113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.34|STANDARD_ERROR_OF_MEAN|2.33|<|0.001|TWO_SIDED|95.0|-59.94|-50.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-50.74|-59.94|<0.001
70995150|NCT01763866|141499113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.87|STANDARD_ERROR_OF_MEAN|3.24|<|0.001|TWO_SIDED|95.0|-63.27|-50.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-50.46|-63.27|<0.001
70995151|NCT01763866|141499114|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-58.79|STANDARD_ERROR_OF_MEAN|2.66|<|0.001|TWO_SIDED|95.0|-64.03|-53.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-53.55|-64.03|<0.001
70995152|NCT01763866|141499114|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.36|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|-53.2|-41.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-41.52|-53.20|<0.001
70995153|NCT01763866|141499114|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.92|STANDARD_ERROR_OF_MEAN|2.69|<|0.001|TWO_SIDED|95.0|-40.23|-29.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.60|-40.23|<0.001
70995154|NCT01763866|141499114|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.21|STANDARD_ERROR_OF_MEAN|2.97|<|0.001|TWO_SIDED|95.0|-42.06|-30.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-30.35|-42.06|<0.001
70995155|NCT01763866|141499114|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.4|STANDARD_ERROR_OF_MEAN|3.99|<|0.001|TWO_SIDED|95.0|-69.27|-53.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-53.54|-69.27|<0.001
70995156|NCT01763866|141499114|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-53.01|STANDARD_ERROR_OF_MEAN|3.93|<|0.001|TWO_SIDED|95.0|-60.77|-45.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-45.25|-60.77|<0.001
70995157|NCT01763866|141499114|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.45|STANDARD_ERROR_OF_MEAN|3.91|<|0.001|TWO_SIDED|95.0|-45.17|-29.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.74|-45.17|<0.001
71040526|NCT05068661|141589407|SUPERIORITY||Mean Ratio|1.9||||0.128|TWO_SIDED|95.0|1.14|3.18||Adjusted P value|Regression, Linear|||||3.18|1.14|0.128
71040527|NCT05068661|141589408|SUPERIORITY||Mean Ratio|1.04|||>|0.999|TWO_SIDED|95.0|0.8|1.35||Adjusted P value|Regression, Linear|||||1.35|0.80|>0.999
71040528|NCT05068661|141589409|SUPERIORITY||Mean Ratio|0.97|||>|0.999|TWO_SIDED|95.0|0.93|1.3||Adjusted P value|Regression, Linear|||||1.30|0.93|>0.999
71040529|NCT05068661|141589410|SUPERIORITY||Risk Ratio (RR)|0.81|||>|0.999|TWO_SIDED|95.0|0.52|1.25||Adjusted P value|Chi-squared|||||1.25|0.52|>0.999
70995158|NCT01763866|141499114|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.31|STANDARD_ERROR_OF_MEAN|3.98|<|0.001|TWO_SIDED|95.0|-42.15|-26.47||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-26.47|-42.15|<0.001
70995159|NCT01763866|141499114|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.5|STANDARD_ERROR_OF_MEAN|2.58|<|0.001|TWO_SIDED|95.0|-61.6|-51.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.40|-61.60|<0.001
70995160|NCT01763866|141499114|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-53.21|STANDARD_ERROR_OF_MEAN|2.57|<|0.001|TWO_SIDED|95.0|-58.29|-48.13||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-48.13|-58.29|<0.001
70995161|NCT01763866|141499114|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.52|STANDARD_ERROR_OF_MEAN|3.31|<|0.001|TWO_SIDED|95.0|-57.06|-43.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-43.99|-57.06|<0.001
70995162|NCT01763866|141499114|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.95|STANDARD_ERROR_OF_MEAN|3.78|<|0.001|TWO_SIDED|95.0|-54.43|-39.47||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-39.47|-54.43|<0.001
70995163|NCT01763866|141499114|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.3|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|-61.47|-51.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.14|-61.47|<0.001
70995164|NCT01763866|141499114|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.73|STANDARD_ERROR_OF_MEAN|3.38|<|0.001|TWO_SIDED|95.0|-59.4|-46.06||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-46.06|-59.40|<0.001
70995165|NCT01763866|141499115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.41|STANDARD_ERROR_OF_MEAN|2.16|<|0.001|TWO_SIDED|95.0|-50.66|-42.15||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-42.15|-50.66|<0.001
70995166|NCT01763866|141499115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.69|STANDARD_ERROR_OF_MEAN|2.57|<|0.001|TWO_SIDED|95.0|-49.75|-39.63||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-39.63|-49.75|<0.001
70995167|NCT01763866|141499115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.06|STANDARD_ERROR_OF_MEAN|2.19|<|0.001|TWO_SIDED|95.0|-30.36|-21.75||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-21.75|-30.36|<0.001
70995168|NCT01763866|141499115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.59|STANDARD_ERROR_OF_MEAN|2.55|<|0.001|TWO_SIDED|95.0|-36.61|-26.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-26.57|-36.61|<0.001
70995169|NCT01763866|141499115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.48|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-50.69|-38.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-38.27|-50.69|<0.001
70995170|NCT01763866|141499115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.85|STANDARD_ERROR_OF_MEAN|2.86|<|0.001|TWO_SIDED|95.0|-52.48|-41.21||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-41.21|-52.48|<0.001
71040530|NCT05068661|141589411|SUPERIORITY||Risk Ratio (RR)|0.85|||>|0.999|TWO_SIDED|95.0|0.58|1.24||Adjusted P value|Chi-squared|||||1.24|0.58|>0.999
70995171|NCT01763866|141499115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.3|STANDARD_ERROR_OF_MEAN|3.09|<|0.001|TWO_SIDED|95.0|-34.39|-22.21||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-22.21|-34.39|<0.001
70995172|NCT01763866|141499115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.18|STANDARD_ERROR_OF_MEAN|2.88|<|0.001|TWO_SIDED|95.0|-33.86|-22.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-22.50|-33.86|<0.001
71040531|NCT05068661|141589412|SUPERIORITY||Mean Ratio|1.03|||>|0.999|TWO_SIDED|95.0|0.86|1.22||Adjusted P value|Regression, Linear|||||1.22|0.86|>0.999
71040532|NCT03980522|141589469|OTHER||Inter-subject variance|19.1908|||||TWO_SIDED|||||||||"Inter-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and standard deviation (SD) from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
70995173|NCT01763866|141499115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.73|STANDARD_ERROR_OF_MEAN|2.41|<|0.001|TWO_SIDED|95.0|-49.5|-39.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-39.97|-49.50|<0.001
70995174|NCT01763866|141499115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.01|STANDARD_ERROR_OF_MEAN|2.75|<|0.001|TWO_SIDED|95.0|-52.46|-41.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-41.57|-52.46|<0.001
70995175|NCT01763866|141499115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.59|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-45.38|-35.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-35.79|-45.38|<0.001
70995176|NCT01763866|141499115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.33|STANDARD_ERROR_OF_MEAN|2.87|<|0.001|TWO_SIDED|95.0|-46.0|-34.66||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-34.66|-46.00|<0.001
70995177|NCT01763866|141499115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.05|STANDARD_ERROR_OF_MEAN|2.38|<|0.001|TWO_SIDED|95.0|-51.76|-42.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-42.35|-51.76|<0.001
70995178|NCT01763866|141499115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-48.62|STANDARD_ERROR_OF_MEAN|2.86|<|0.001|TWO_SIDED|95.0|-54.27|-42.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-42.98|-54.27|<0.001
71040533|NCT03980522|141589469|OTHER||Inter-subject variance|0.0018|||||TWO_SIDED|||||||||"Inter-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
70995179|NCT01763866|141499116|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.83|STANDARD_ERROR_OF_MEAN|2.48|<|0.001|TWO_SIDED|95.0|-51.73|-41.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-41.94|-51.73|<0.001
70995180|NCT01763866|141499116|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-42.86|STANDARD_ERROR_OF_MEAN|2.82|<|0.001|TWO_SIDED|95.0|-48.43|-37.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-37.30|-48.43|<0.001
70995181|NCT01763866|141499116|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.6|STANDARD_ERROR_OF_MEAN|2.51|<|0.001|TWO_SIDED|95.0|-33.56|-23.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-23.65|-33.56|<0.001
70995182|NCT01763866|141499116|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-30.22|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-35.74|-24.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-24.70|-35.74|<0.001
70995183|NCT01763866|141499116|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.1|STANDARD_ERROR_OF_MEAN|3.33|<|0.001|TWO_SIDED|95.0|-51.66|-38.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-38.54|-51.66|<0.001
70995184|NCT01763866|141499116|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-42.43|STANDARD_ERROR_OF_MEAN|3.34|<|0.001|TWO_SIDED|95.0|-49.01|-35.85||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-35.85|-49.01|<0.001
70995185|NCT01763866|141499116|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-30.26|STANDARD_ERROR_OF_MEAN|3.26|<|0.001|TWO_SIDED|95.0|-36.68|-23.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-23.84|-36.68|<0.001
70995186|NCT01763866|141499116|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.19|STANDARD_ERROR_OF_MEAN|3.35|<|0.001|TWO_SIDED|95.0|-31.79|-18.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-18.59|-31.79|<0.001
70995187|NCT01763866|141499116|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.25|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-48.77|-37.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-37.74|-48.77|<0.001
70995188|NCT01763866|141499116|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.33|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-51.04|-39.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-39.61|-51.04|<0.001
70995189|NCT01763866|141499116|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.13|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-46.65|-35.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-35.61|-46.65|<0.001
70995190|NCT01763866|141499116|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.99|STANDARD_ERROR_OF_MEAN|3.41|<|0.001|TWO_SIDED|95.0|-41.72|-28.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-28.25|-41.72|<0.001
70995191|NCT01763866|141499116|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.04|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-51.83|-42.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-42.25|-51.83|<0.001
70995192|NCT01763866|141499116|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.6|STANDARD_ERROR_OF_MEAN|3.07|<|0.001|TWO_SIDED|95.0|-50.67|-38.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-38.54|-50.67|<0.001
70995193|NCT01763866|141499117|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.97|STANDARD_ERROR_OF_MEAN|2.51|<|0.001|TWO_SIDED|95.0|-64.91|-55.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-55.03|-64.91|<0.001
70995194|NCT01763866|141499117|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.11|STANDARD_ERROR_OF_MEAN|2.77|<|0.001|TWO_SIDED|95.0|-59.57|-48.64||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-48.64|-59.57|<0.001
70995195|NCT01763866|141499117|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.79|STANDARD_ERROR_OF_MEAN|2.54|<|0.001|TWO_SIDED|95.0|-42.8|-32.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-32.77|-42.80|<0.001
70995196|NCT01763866|141499117|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.86|STANDARD_ERROR_OF_MEAN|2.78|<|0.001|TWO_SIDED|95.0|-47.34|-36.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-36.67|-47.34|<0.001
70995197|NCT01763866|141499117|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.9|STANDARD_ERROR_OF_MEAN|3.71|<|0.001|TWO_SIDED|95.0|-64.22|-49.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-49.59|-64.22|<0.001
70995198|NCT01763866|141499117|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.99|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-68.68|-55.29||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-55.29|-68.68|<0.001
70995199|NCT01763866|141499117|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.26|STANDARD_ERROR_OF_MEAN|3.66|<|0.001|TWO_SIDED|95.0|-44.48|-30.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-30.04|-44.48|<0.001
70995200|NCT01763866|141499117|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.29|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-50.07|-36.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-36.51|-50.07|<0.001
70995201|NCT01763866|141499117|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.29|STANDARD_ERROR_OF_MEAN|2.78|<|0.001|TWO_SIDED|95.0|-60.79|-49.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-49.79|-60.79|<0.001
70995202|NCT01763866|141499117|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.24|STANDARD_ERROR_OF_MEAN|2.49|<|0.001|TWO_SIDED|95.0|-64.16|-54.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-54.32|-64.16|<0.001
70995203|NCT01763866|141499117|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.63|STANDARD_ERROR_OF_MEAN|3.13|<|0.001|TWO_SIDED|95.0|-56.82|-44.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-44.45|-56.82|<0.001
70995204|NCT01763866|141499117|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.78|STANDARD_ERROR_OF_MEAN|3.61|<|0.001|TWO_SIDED|95.0|-63.91|-49.64||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-49.64|-63.91|<0.001
70995205|NCT01763866|141499117|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.75|STANDARD_ERROR_OF_MEAN|2.41|<|0.001|TWO_SIDED|95.0|-62.51|-52.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-52.99|-62.51|<0.001
70995206|NCT01763866|141499117|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.06|STANDARD_ERROR_OF_MEAN|2.93|<|0.001|TWO_SIDED|95.0|-61.85|-50.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-50.27|-61.85|<0.001
70995207|NCT01763866|141499118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.29|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED|95.0|-65.65|-54.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-54.94|-65.65|<0.001
70995208|NCT01763866|141499118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-48.44|STANDARD_ERROR_OF_MEAN|2.94|<|0.001|TWO_SIDED|95.0|-54.23|-42.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-42.65|-54.23|<0.001
70995209|NCT01763866|141499118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.66|STANDARD_ERROR_OF_MEAN|2.75|<|0.001|TWO_SIDED|95.0|-45.09|-34.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-34.23|-45.09|<0.001
70995210|NCT01763866|141499118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.32|STANDARD_ERROR_OF_MEAN|2.94|<|0.001|TWO_SIDED|95.0|-43.12|-31.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-31.52|-43.12|<0.001
70995211|NCT01763866|141499118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.77|STANDARD_ERROR_OF_MEAN|3.95|<|0.001|TWO_SIDED|95.0|-65.55|-49.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-49.99|-65.55|<0.001
70995212|NCT01763866|141499118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.26|STANDARD_ERROR_OF_MEAN|3.88|<|0.001|TWO_SIDED|95.0|-64.91|-49.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-49.60|-64.91|<0.001
71040534|NCT03980522|141589469|OTHER||Inter-subject variance|0.0|||||TWO_SIDED|||||||||"Inter-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
71040535|NCT03980522|141589469|OTHER||Intra-subject variance|12.6852|||||TWO_SIDED|||||||||"Intra-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
71040536|NCT03980522|141589469|OTHER||Intra-subject variance|0.1842|||||TWO_SIDED|||||||||"Intra-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
71040537|NCT03980522|141589469|OTHER||Intra-subject variance|1.0|||||TWO_SIDED|||||||||"Intra-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
71040538|NCT03980522|141589470|OTHER||Inter-subject variance|34.1446|||||TWO_SIDED|||||||||"Inter-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with change from baseline in CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
71040539|NCT03980522|141589470|OTHER||Inter-subject variance|0.1326|||||TWO_SIDED|||||||||"Inter-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with change from baseline in CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
71040540|NCT03980522|141589470|OTHER||Inter-subject variance|0.0|||||TWO_SIDED|||||||||"Inter-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with change from baseline in CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
71040541|NCT03980522|141589470|OTHER||Intra-subject variance|0.0548|||||TWO_SIDED|||||||||"Intra-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with change from baseline in CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
71040542|NCT03980522|141589470|OTHER||Intra-subject variance|0.0134|||||TWO_SIDED|||||||||"Intra-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with change from baseline in CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
70995213|NCT01763866|141499118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.9|STANDARD_ERROR_OF_MEAN|3.87|<|0.001|TWO_SIDED|95.0|-47.53|-32.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-32.26|-47.53|<0.001
70995214|NCT01763866|141499118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.57|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|95.0|-46.26|-30.88||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-30.88|-46.26|<0.001
70995215|NCT01763866|141499118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.41|STANDARD_ERROR_OF_MEAN|2.83|<|0.001|TWO_SIDED|95.0|-59.99|-48.82||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-48.82|-59.99|<0.001
70995216|NCT01763866|141499118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.13|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-61.58|-50.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-50.68|-61.58|<0.001
70995217|NCT01763866|141499118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-49.17|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|-55.8|-42.53||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-42.53|-55.80|<0.001
70995218|NCT01763866|141499118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-48.81|STANDARD_ERROR_OF_MEAN|4.25|<|0.001|TWO_SIDED|95.0|-57.21|-40.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-40.40|-57.21|<0.001
70995219|NCT01763866|141499118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.73|STANDARD_ERROR_OF_MEAN|2.57|<|0.001|TWO_SIDED|95.0|-62.82|-52.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-52.65|-62.82|<0.001
70995220|NCT01763866|141499118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.04|STANDARD_ERROR_OF_MEAN|3.07|<|0.001|TWO_SIDED|95.0|-58.1|-45.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-45.98|-58.10|<0.001
70995221|NCT01763866|141499119|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|82.4|||<|0.001|TWO_SIDED|95.0|70.2|88.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)||||88.5|70.2|<0.001
70995222|NCT01763866|141499119|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|80.3|||<|0.001|TWO_SIDED|95.0|67.9|86.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||86.8|67.9|<0.001
70995223|NCT01763866|141499119|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|68.1|||<|0.001|TWO_SIDED|95.0|53.1|78.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||78.1|53.1|<0.001
70995224|NCT01763866|141499119|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|69.2|||<|0.001|TWO_SIDED|95.0|54.8|78.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)||||78.5|54.8|<0.001
70995225|NCT01763866|141499119|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|80.7|||<|0.001|TWO_SIDED|95.0|67.3|88.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||88.3|67.3|<0.001
70995226|NCT01763866|141499119|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|83.3|||<|0.001|TWO_SIDED|95.0|70.7|89.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)||||89.6|70.7|<0.001
70995227|NCT01763866|141499119|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|43.5|||<|0.001|TWO_SIDED|95.0|29.5|56.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||56.7|29.5|<0.001
70995228|NCT01763866|141499119|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|30.3|||<|0.001|TWO_SIDED|95.0|16.7|44.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||44.2|16.7|<0.001
70995229|NCT01763866|141499119|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|81.7|||<|0.001|TWO_SIDED|95.0|69.5|88.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||88.0|69.5|<0.001
70995230|NCT01763866|141499119|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|84.6|||<|0.001|TWO_SIDED|95.0|73.1|90.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||90.2|73.1|<0.001
70995231|NCT01763866|141499119|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|54.6|||<|0.001|TWO_SIDED|95.0|39.8|66.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||66.9|39.8|<0.001
70995232|NCT01763866|141499119|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|65.7|||<|0.001|TWO_SIDED|95.0|51.0|76.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||76.6|51.0|<0.001
70995233|NCT01763866|141499119|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|91.7|||<|0.001|TWO_SIDED|95.0|81.6|95.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||95.3|81.6|<0.001
70995234|NCT01763866|141499119|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|84.6|||<|0.001|TWO_SIDED|95.0|72.8|90.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||90.0|72.8|<0.001
71040543|NCT03980522|141589470|OTHER||Intra-subject variance|1.0|||||TWO_SIDED|||||||||"Intra-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with change from baseline in CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
71040544|NCT03980522|141589471|OTHER||Inter-subject variance|2.8139|||||TWO_SIDED|||||||||"Inter-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
71040545|NCT03980522|141589471|OTHER||Inter-subject variance|6.9999|||||TWO_SIDED|||||||||"Inter-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
71040546|NCT03980522|141589471|OTHER||Inter-subject variance|0.0|||||TWO_SIDED|||||||||"Inter-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
71040547|NCT03980522|141589471|OTHER||Intra-subject variance|0.9693|||||TWO_SIDED|||||||||"Intra-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
71040548|NCT03980522|141589471|OTHER||Intra-subject variance|0.0|||||TWO_SIDED|||||||||"Intra-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
71040549|NCT03980522|141589471|OTHER||Intra-subject variance|1.0|||||TWO_SIDED|||||||||"Intra-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
70995235|NCT01763866|141499120|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|83.5|||<|0.001|TWO_SIDED|95.0|71.9|89.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)||||89.2|71.9|<0.001
70995236|NCT01763866|141499120|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|78.3|||<|0.001|TWO_SIDED|95.0|65.2|85.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||85.3|65.2|<0.001
70995237|NCT01763866|141499120|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|63.0|||<|0.001|TWO_SIDED|95.0|47.3|73.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||73.9|47.3|<0.001
70995238|NCT01763866|141499120|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|64.9|||<|0.001|TWO_SIDED|95.0|49.8|75.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)||||75.2|49.8|<0.001
70995239|NCT01763866|141499120|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|80.1|||<|0.001|TWO_SIDED|95.0|65.8|87.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||87.9|65.8|<0.001
70995240|NCT01763866|141499120|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|81.2|||<|0.001|TWO_SIDED|95.0|67.9|88.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)||||88.1|67.9|<0.001
71040550|NCT03980522|141589472|OTHER||Inter-subject variance|1.9968|||||TWO_SIDED|||||||||"Inter-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
71040551|NCT03980522|141589472|OTHER||Inter-subject variance|0.9047|||||TWO_SIDED|||||||||"Inter-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
71040552|NCT03980522|141589472|OTHER||Inter-subject variance|0.0|||||TWO_SIDED|||||||||"Inter-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
71099750|NCT03782103|141708602|SUPERIORITY|Investigational product lower bounds must be greater than 1.2.|Mean Difference (Final Values)|1.8208|||||TWO_SIDED|95.0|1.6153|2.0264||||||Abdomen 30 seconds post product application, Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||2.0264|1.6153|
71099751|NCT00452400|141708646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.027||0.0233||95.0|0.008|0.113|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.113|0.008|0.0233
70995241|NCT01763866|141499120|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|41.1|||<|0.001|TWO_SIDED|95.0|26.4|55.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||55.1|26.4|<0.001
71040553|NCT03980522|141589472|OTHER||Intra-subject variance|1.7598|||||TWO_SIDED|||||||||"Intra-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
71099752|NCT00452400|141708646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.027||0.0003||95.0|0.044|0.149|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.149|0.044|0.0003
70995242|NCT01763866|141499120|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|35.2|||<|0.001|TWO_SIDED|95.0|20.7|49.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||49.3|20.7|<0.001
70995243|NCT01763866|141499120|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|77.3|||<|0.001|TWO_SIDED|95.0|63.9|84.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||84.7|63.9|<0.001
70995244|NCT01763866|141499120|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|81.1|||<|0.001|TWO_SIDED|95.0|68.8|87.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||87.5|68.8|<0.001
70995245|NCT01763866|141499120|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|52.7|||<|0.001|TWO_SIDED|95.0|37.6|65.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||65.3|37.6|<0.001
70995246|NCT01763866|141499120|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|64.3|||<|0.001|TWO_SIDED|95.0|49.1|75.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||75.5|49.1|<0.001
70995247|NCT01763866|141499120|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|92.5|||<|0.001|TWO_SIDED|95.0|82.3|95.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||95.9|82.3|<0.001
70995248|NCT01763866|141499120|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|78.4|||<|0.001|TWO_SIDED|95.0|64.9|85.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||85.4|64.9|<0.001
70995249|NCT01763866|141499121|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.08|STANDARD_ERROR_OF_MEAN|3.54|<|0.001|TWO_SIDED|95.0|-39.06|-25.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-25.11|-39.06|<0.001
70995250|NCT01763866|141499121|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-21.86|STANDARD_ERROR_OF_MEAN|3.98|<|0.001|TWO_SIDED|95.0|-29.7|-14.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-14.03|-29.70|<0.001
70995251|NCT01763866|141499121|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.45|STANDARD_ERROR_OF_MEAN|3.59|<|0.001|TWO_SIDED|95.0|-34.53|-20.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-20.38|-34.53|<0.001
70995252|NCT01763866|141499121|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-29.49|STANDARD_ERROR_OF_MEAN|3.99|<|0.001|TWO_SIDED|95.0|-37.36|-21.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-21.62|-37.36|<0.001
71099753|NCT00452400|141708646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.072|0.175|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.175|0.072|<0.0001
71099754|NCT00452400|141708646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.08|0.185|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.185|0.080|<0.0001
71099755|NCT00452400|141708647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.025||0.0004||95.0|0.039|0.137|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.137|0.039|0.0004
71099756|NCT00452400|141708647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001||95.0|0.088|0.186|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.186|0.088|<0.0001
71099757|NCT00452400|141708647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.08|0.176|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.176|0.080|<0.0001
71099758|NCT00452400|141708647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001||95.0|0.12|0.218|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.218|0.120|<0.0001
71099759|NCT00452400|141708648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.026||0.0011||95.0|0.034|0.136|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.136|0.034|0.0011
71099760|NCT00452400|141708648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.07|0.173|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.173|0.070|<0.0001
71099761|NCT00452400|141708648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.075|0.175|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.175|0.075|<0.0001
71099762|NCT00452400|141708648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.077|0.179|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.179|0.077|<0.0001
71099763|NCT00452400|141708649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.044||0.0127||95.0|0.024|0.197|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.197|0.024|0.0127
70995253|NCT01763866|141499121|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-20.52|STANDARD_ERROR_OF_MEAN|3.65|<|0.001|TWO_SIDED|95.0|-27.71|-13.33||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-13.33|-27.71|<0.001
70995254|NCT01763866|141499121|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.96|STANDARD_ERROR_OF_MEAN|4.08|<|0.001|TWO_SIDED|95.0|-37.01|-20.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-20.92|-37.01|<0.001
71040554|NCT03980522|141589472|OTHER||Intra-subject variance|2.849|||||TWO_SIDED|||||||||"Intra-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
71040555|NCT03980522|141589472|OTHER||Intra-subject variance|1.0|||||TWO_SIDED|||||||||"Intra-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
71040556|NCT04892147|141589475|OTHER|"Mean value of Enjoyment (8-item summed scale) tested against the value of a Neutral Likert response (Neutral value = 3)."|||||<|0.001||||||The threshold for statistical significance was p = 0.05. The reported value is a calculated -p-value.|t-test, 2 sided|||||||<0.001
71040557|NCT04892147|141589476|EQUIVALENCE|Analyses were conducted using general linear models, controlling for baseline levels only with treatment group as the predictor of interest.||||||0.259||||||The threshold for statistical significance was p = 0.05|Regression, Linear|||||||0.259
71040558|NCT04892147|141589477|EQUIVALENCE|Analyses were conducted using general linear models, controlling for baseline levels only with treatment group as the predictor of interest.||||||0.711||||||The threshold for statistical significance was p = 0.05.|Regression, Linear|||||||0.711
71040559|NCT04892147|141589478|EQUIVALENCE|Analyses were conducted using general linear models, controlling for baseline levels only with treatment group as the predictor of interest.||||||0.214||||||The threshold for statistical significance was p = 0.05.|Regression, Linear|||||||0.214
71040560|NCT04892147|141589479|EQUIVALENCE|Analyses were conducted using general linear models, controlling for baseline levels only with treatment group as the predictor of interest.||||||0.317||||||The threshold for statistical significance was p = 0.05.|Regression, Linear|||||||0.317
71040561|NCT04892147|141589480|EQUIVALENCE|Analyses were conducted using general linear models, controlling for baseline levels only with treatment group as the predictor of interest.||||||0.056||||||The threshold for statistical significance was p = 0.05.|Regression, Linear|||||||0.056
71040562|NCT04892147|141589481|EQUIVALENCE|Analyses were conducted using general linear models, controlling for baseline levels only with treatment group as the predictor of interest.||||||0.562||||||The threshold for statistical significance was p = 0.05.|Regression, Linear|||||||0.562
71040563|NCT02707276|141589487|SUPERIORITY||Mean Difference (Final Values)|-0.625|STANDARD_DEVIATION|12.0|<|0.76|TWO_SIDED||||||ANCOVA|repeated measures ANCOVA|mean raw change active-sham; pooled standard deviation|Repeated measures ANCOVA with baseline MADRS scores as covariate for treatment and order effects of difference in MADRS scores.||||<0.76
71040564|NCT02707276|141589487|SUPERIORITY||Mean Difference (Final Values)|-5.17|STANDARD_DEVIATION|4.96|<|0.33|TWO_SIDED||||||ANCOVA|Baseline covariate|Pooled deviation|ANCOVA: Analysis of group differences in change scores with baseline as a covariate||||<0.33
71040565|NCT02707276|141589488|SUPERIORITY||Mean Difference (Net)|2.0|STANDARD_DEVIATION|9.1|<|0.61|TWO_SIDED||||||ANCOVA|repeated measures ANCOVA|raw change active-sham mean; pooled standard deviation|Repeated measures ANCOVA with baseline HARS scores as covariate for treatment and order effects of difference in HARS scores.||||<0.61
71040566|NCT02707276|141589488|SUPERIORITY||Mean Difference (Final Values)|-4.33|STANDARD_DEVIATION|4.0|<|0.32|TWO_SIDED||||||ANCOVA|baseline as covariate|pooled deviation|ANCOVA: Analysis of group differences in change scores with baseline as a covariate||||<0.32
71040567|NCT02707276|141589489|SUPERIORITY||Mean Difference (Final Values)|-1.625|STANDARD_DEVIATION|10.2|<|0.78|TWO_SIDED||||||ANCOVA|repeated measures ANCOVA|raw active-sham mean; pooled standard deviation|Repeated measures ANCOVA with baseline PANAS (Positive sub scale) scores as covariate for treatment and order effects of difference in PANAS (Positive sub scale) scores.||||<0.78
71099764|NCT00452400|141708649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.044|<|0.0001||95.0|0.087|0.261|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.261|0.087|<0.0001
71099765|NCT00452400|141708649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.043||0.0001||95.0|0.084|0.255|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.255|0.084|0.0001
71040568|NCT02707276|141589489|SUPERIORITY||Mean Difference (Final Values)|-0.33|STANDARD_DEVIATION|2.42|<|0.99|TWO_SIDED||||||ANCOVA|baseline as covariate|pooled deviation|ANCOVA: Analysis of group differences in change scores with baseline as a covariate||||<0.99
71040569|NCT00360490|141589536|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis: the absolute change from Baseline MBL to End of Study MBL is equal in the LNG IUS group and the MPA group.||||<0.001
71040570|NCT00360490|141589537|SUPERIORITY_OR_OTHER||Risk Difference (RD)|62.59|||<|0.001||95.0|50.56|74.61|||Chi-squared|||The null hypothesis: the proportion of subjects with successful treatment is equal in the LNG IUS group and the MPA group.||74.61|50.56|<0.001
70995255|NCT01763866|141499121|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.02|STANDARD_ERROR_OF_MEAN|3.6|<|0.001|TWO_SIDED|95.0|-39.11|-24.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-24.93|-39.11|<0.001
70995256|NCT01763866|141499121|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.42|STANDARD_ERROR_OF_MEAN|4.15|<|0.001|TWO_SIDED|95.0|-45.61|-29.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.23|-45.61|<0.001
70995257|NCT01763866|141499121|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.66|STANDARD_ERROR_OF_MEAN|3.69|<|0.001|TWO_SIDED|95.0|-42.94|-28.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-28.38|-42.94|<0.001
70995258|NCT01763866|141499121|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.81|STANDARD_ERROR_OF_MEAN|4.33|<|0.001|TWO_SIDED|95.0|-35.36|-18.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-18.27|-35.36|<0.001
70995259|NCT01763866|141499121|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.56|STANDARD_ERROR_OF_MEAN|3.64|<|0.001|TWO_SIDED|95.0|-40.74|-26.37||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-26.37|-40.74|<0.001
70995260|NCT01763866|141499121|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.19|STANDARD_ERROR_OF_MEAN|4.36|<|0.001|TWO_SIDED|95.0|-40.8|-23.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-23.58|-40.80|<0.001
70995261|NCT01763866|141499121|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.07|STANDARD_ERROR_OF_MEAN|3.46|<|0.001|TWO_SIDED|95.0|-34.91|-21.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-21.23|-34.91|<0.001
70995262|NCT01763866|141499121|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.16|STANDARD_ERROR_OF_MEAN|3.76|<|0.001|TWO_SIDED|95.0|-34.59|-19.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-19.73|-34.59|<0.001
70995263|NCT01763866|141499122|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.2|STANDARD_ERROR_OF_MEAN|3.86|<|0.001|TWO_SIDED|95.0|-40.81|-25.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-25.60|-40.81|<0.001
71040571|NCT00360490|141589538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-49.2|||<|0.001||95.0|-70.2|-28.3|||t-test, 2 sided|||The null hypothesis: the percent change from Baseline MBL to End of Study MBL is equal in the LNG IUS group and the MPA group.||-28.3|-70.2|<0.001
71040572|NCT00360490|141589539|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis: the absolute change from Baseline MBL to Mid-study MBL is equal in the LNG IUS group and the MPA group.||||<0.001
71099766|NCT00452400|141708649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.044||0.0001||95.0|0.084|0.258|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.258|0.084|0.0001
71099767|NCT00452400|141708650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.052||0.0836||95.0|-0.012|0.192|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.192|-0.012|0.0836
70995264|NCT01763866|141499122|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-19.82|STANDARD_ERROR_OF_MEAN|4.11|<|0.001|TWO_SIDED|95.0|-27.92|-11.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-11.72|-27.92|<0.001
70995265|NCT01763866|141499122|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-29.16|STANDARD_ERROR_OF_MEAN|3.91|<|0.001|TWO_SIDED|95.0|-36.87|-21.44||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-21.44|-36.87|<0.001
70995266|NCT01763866|141499122|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.44|STANDARD_ERROR_OF_MEAN|4.12|<|0.001|TWO_SIDED|95.0|-35.56|-19.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-19.32|-35.56|<0.001
71040573|NCT00360490|141589540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.6|||<|0.001||95.0|-63.8|-37.4|||t-test, 2 sided|||The null hypothesis: the percent change from Baseline MBL to Mid-study MBL is equal in the LNG IUS group and the MPA group.||-37.4|-63.8|<0.001
71040574|NCT00360490|141589550|SUPERIORITY_OR_OTHER||Risk Difference (RD)|26.06||||||95.0|14.75|37.36||||||A two-sided 95% confidence interval for the improvement rate will be provided for cycle 6||37.36|14.75|
70995267|NCT01763866|141499122|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.38|STANDARD_ERROR_OF_MEAN|4.07|<|0.001|TWO_SIDED|95.0|-30.39|-14.36||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-14.36|-30.39|<0.001
70995268|NCT01763866|141499122|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.1|STANDARD_ERROR_OF_MEAN|4.32|<|0.001|TWO_SIDED|95.0|-36.62|-19.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-19.58|-36.62|<0.001
70995269|NCT01763866|141499122|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.62|STANDARD_ERROR_OF_MEAN|3.98|<|0.001|TWO_SIDED|95.0|-40.46|-24.78||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-24.78|-40.46|<0.001
70995270|NCT01763866|141499122|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.88|STANDARD_ERROR_OF_MEAN|4.38|<|0.001|TWO_SIDED|95.0|-43.52|-26.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-26.25|-43.52|<0.001
70995271|NCT01763866|141499122|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.5|STANDARD_ERROR_OF_MEAN|4.15|<|0.001|TWO_SIDED|95.0|-44.69|-28.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-28.30|-44.69|<0.001
70995272|NCT01763866|141499122|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.34|STANDARD_ERROR_OF_MEAN|4.48|<|0.001|TWO_SIDED|95.0|-34.19|-16.49||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-16.49|-34.19|<0.001
70995273|NCT01763866|141499122|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.48|STANDARD_ERROR_OF_MEAN|3.78|<|0.001|TWO_SIDED|95.0|-43.95|-29.02||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.02|-43.95|<0.001
70995274|NCT01763866|141499122|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.17|STANDARD_ERROR_OF_MEAN|5.28|<|0.001|TWO_SIDED|95.0|-42.61|-21.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-21.74|-42.61|<0.001
70995275|NCT01763866|141499122|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.25|STANDARD_ERROR_OF_MEAN|3.62|<|0.001|TWO_SIDED|95.0|-38.4|-24.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-24.10|-38.40|<0.001
70995276|NCT01763866|141499122|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.17|STANDARD_ERROR_OF_MEAN|4.36|<|0.001|TWO_SIDED|95.0|-36.79|-19.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-19.55|-36.79|<0.001
70995277|NCT01763866|141499123|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-12.1|STANDARD_ERROR_OF_MEAN|4.83||0.2|TWO_SIDED|95.0|-21.63|-2.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-2.58|-21.63|0.20
70995278|NCT01763866|141499123|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.55|STANDARD_ERROR_OF_MEAN|5.36||0.003|TWO_SIDED|95.0|-33.13|-11.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-11.97|-33.13|0.003
70995279|NCT01763866|141499123|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-2.45|STANDARD_ERROR_OF_MEAN|4.89||1|TWO_SIDED|95.0|-12.09|7.19||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||7.19|-12.09|1.00
70995280|NCT01763866|141499123|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-14.95|STANDARD_ERROR_OF_MEAN|5.33||0.053|TWO_SIDED|95.0|-25.46|-4.44||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-4.44|-25.46|0.053
70995281|NCT01763866|141499123|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-15.43|STANDARD_ERROR_OF_MEAN|4.89||0.073|TWO_SIDED|95.0|-25.06|-5.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-5.79|-25.06|0.073
70995282|NCT01763866|141499123|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-14.41|STANDARD_ERROR_OF_MEAN|5.32||0.027|TWO_SIDED|95.0|-24.9|-3.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-3.92|-24.90|0.027
70995283|NCT01763866|141499123|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-1.17|STANDARD_ERROR_OF_MEAN|4.8||1|TWO_SIDED|95.0|-10.63|8.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||8.30|-10.63|1.00
70995284|NCT01763866|141499123|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-1.51|STANDARD_ERROR_OF_MEAN|5.38||0.63|TWO_SIDED|95.0|-12.12|9.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.11|-12.12|0.63
70995285|NCT01763866|141499123|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.72|STANDARD_ERROR_OF_MEAN|5.15|<|0.001|TWO_SIDED|95.0|-32.9|-12.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-12.54|-32.90|<0.001
70995286|NCT01763866|141499123|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-19.52|STANDARD_ERROR_OF_MEAN|5.69||0.007|TWO_SIDED|95.0|-30.76|-8.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-8.28|-30.76|0.007
70995287|NCT01763866|141499123|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-17.59|STANDARD_ERROR_OF_MEAN|4.62||0.002|TWO_SIDED|95.0|-26.71|-8.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-8.46|-26.71|0.002
70995288|NCT01763866|141499123|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.18|STANDARD_ERROR_OF_MEAN|4.85|<|0.001|TWO_SIDED|95.0|-35.76|-16.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-16.59|-35.76|<0.001
70995289|NCT01763866|141499123|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-20.97|STANDARD_ERROR_OF_MEAN|5.78|<|0.001|TWO_SIDED|95.0|-32.38|-9.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-9.55|-32.38|<0.001
71040575|NCT01160640|141589561|SUPERIORITY_OR_OTHER|||||||0.046||||||P-value for proportion of women who had clearance of anaerobic organisms from the endometrium at the 30-day visit|Fisher Exact|||||||0.046
71040576|NCT01160640|141589563|SUPERIORITY_OR_OTHER|||||||0.16||||||P-value for proportion of women who did not have M. genitalium detected in the cervix or endometrium at the 30-day visit|Fisher Exact|||||||0.16
70995290|NCT01763866|141499123|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-29.71|STANDARD_ERROR_OF_MEAN|5.64|<|0.001|TWO_SIDED|95.0|-40.84|-18.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-18.57|-40.84|<0.001
70995291|NCT01763866|141499124|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-12.06|STANDARD_ERROR_OF_MEAN|6.41||0.2|TWO_SIDED|95.0|-24.69|0.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||0.57|-24.69|0.20
70995292|NCT01763866|141499124|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.6|STANDARD_ERROR_OF_MEAN|7.23||0.003|TWO_SIDED|95.0|-41.86|-13.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-13.35|-41.86|0.003
70995293|NCT01763866|141499124|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-3.37|STANDARD_ERROR_OF_MEAN|6.49||1|TWO_SIDED|95.0|-16.16|9.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.43|-16.16|1.00
70995294|NCT01763866|141499124|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-18.13|STANDARD_ERROR_OF_MEAN|7.18||0.053|TWO_SIDED|95.0|-32.28|-3.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-3.99|-32.28|0.053
70995295|NCT01763866|141499124|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-16.72|STANDARD_ERROR_OF_MEAN|5.39||0.073|TWO_SIDED|95.0|-27.34|-6.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-6.10|-27.34|0.073
70995296|NCT01763866|141499124|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-9.31|STANDARD_ERROR_OF_MEAN|6.39||0.027|TWO_SIDED|95.0|-21.92|3.29||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||3.29|-21.92|0.027
70995297|NCT01763866|141499124|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-2.67|STANDARD_ERROR_OF_MEAN|5.27||1|TWO_SIDED|95.0|-13.05|7.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||7.72|-13.05|1.00
70995298|NCT01763866|141499124|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|2.02|STANDARD_ERROR_OF_MEAN|6.43||0.63|TWO_SIDED|95.0|-10.66|14.69||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||14.69|-10.66|0.63
71040577|NCT01160640|141589564|SUPERIORITY_OR_OTHER|||||||0.74||||||P-value for proportion of women who experienced resolution of clinical signs and symptoms of PID at the 3-day visit|Fisher Exact|||||||0.74
71099768|NCT00452400|141708650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.052||0.0011||95.0|0.068|0.274|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.274|0.068|0.0011
71099769|NCT00452400|141708650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.051||0.0037||95.0|0.049|0.25|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.250|0.049|0.0037
70995299|NCT01763866|141499124|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-18.03|STANDARD_ERROR_OF_MEAN|7.08|<|0.001|TWO_SIDED|95.0|-32.03|-4.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-4.04|-32.03|<0.001
71099770|NCT00452400|141708650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.052||0.0047||95.0|0.046|0.251|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.251|0.046|0.0047
70995300|NCT01763866|141499124|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-19.83|STANDARD_ERROR_OF_MEAN|6.52||0.007|TWO_SIDED|95.0|-32.71|-6.96||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-6.96|-32.71|0.007
70995301|NCT01763866|141499124|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-16.55|STANDARD_ERROR_OF_MEAN|5.71||0.002|TWO_SIDED|95.0|-27.84|-5.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-5.26|-27.84|0.002
70995302|NCT01763866|141499124|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-20.51|STANDARD_ERROR_OF_MEAN|5.33|<|0.001|TWO_SIDED|95.0|-31.04|-9.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-9.98|-31.04|<0.001
70995303|NCT01763866|141499124|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-21.78|STANDARD_ERROR_OF_MEAN|5.62|<|0.001|TWO_SIDED|95.0|-32.88|-10.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-10.68|-32.88|<0.001
70995304|NCT01763866|141499124|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.36|STANDARD_ERROR_OF_MEAN|6.45|<|0.001|TWO_SIDED|95.0|-44.1|-18.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-18.62|-44.10|<0.001
71040578|NCT00178711|141589629|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08|||=|0.67|TWO_SIDED|95.0|0.76|1.53|||Regression, Logistic|||The primary hypothesis was a two-sided test assessing whether the induction of hypothermia modified the percentage of subjects with poor outcomes at 6 months after injury. Percentages in each group were compared using a generalized linear model with a binomial distribution and log link function, logistic regression model with admission age and baseline GCS as covariates.||1.53|0.76|=0.67
71099771|NCT00452400|141708651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.051||0.0695||95.0|-0.008|0.195|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.195|-0.008|0.0695
70995305|NCT01763866|141499125|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-13.36|STANDARD_ERROR_OF_MEAN|4.38||0.088|TWO_SIDED|95.0|-21.99|-4.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-4.74|-21.99|0.088
70995306|NCT01763866|141499125|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-21.31|STANDARD_ERROR_OF_MEAN|5.41||0.005|TWO_SIDED|95.0|-31.98|-10.64||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-10.64|-31.98|0.005
70995307|NCT01763866|141499125|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-1.5|STANDARD_ERROR_OF_MEAN|4.45||1|TWO_SIDED|95.0|-10.27|7.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||7.27|-10.27|1.00
70995308|NCT01763866|141499125|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-13.54|STANDARD_ERROR_OF_MEAN|5.39||0.056|TWO_SIDED|95.0|-24.17|-2.91||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-2.91|-24.17|0.056
70995309|NCT01763866|141499125|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-15.21|STANDARD_ERROR_OF_MEAN|4.91||0.073|TWO_SIDED|95.0|-24.88|-5.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-5.54|-24.88|0.073
70995310|NCT01763866|141499125|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-14.69|STANDARD_ERROR_OF_MEAN|5.21||0.027|TWO_SIDED|95.0|-24.97|-4.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-4.42|-24.97|0.027
70995311|NCT01763866|141499125|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-0.44|STANDARD_ERROR_OF_MEAN|4.82||1|TWO_SIDED|95.0|-9.94|9.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.05|-9.94|1.00
70995312|NCT01763866|141499125|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-0.25|STANDARD_ERROR_OF_MEAN|5.28||0.62|TWO_SIDED|95.0|-10.66|10.16||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||10.16|-10.66|0.62
71040579|NCT00948792|141589639|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Wilcoxon (Mann-Whitney)|||"The null hypothesis is that there would be no difference in post-transfusion platelet counts (30-minutes post-transfusion) between the two groups.~We opted to determine the number of transfusions that would be required to detect difference of 20,000 platelets/mm3 (with a standard deviation of 20,000). The number shown to demonstrate this was 44."||||0.8
71099772|NCT00452400|141708651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.052||0.0018||95.0|0.061|0.264|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.264|0.061|0.0018
71099773|NCT00452400|141708651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.051||0.0008||95.0|0.072|0.272|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.272|0.072|0.0008
71099774|NCT00452400|141708651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.179|STANDARD_ERROR_OF_MEAN|0.052||0.0006||95.0|0.077|0.281|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.281|0.077|0.0006
71099775|NCT00452400|141708652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.078|0.204|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.204|0.078|<0.0001
71099776|NCT00452400|141708652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.099|0.225|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.225|0.099|<0.0001
71099777|NCT00452400|141708652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.151|0.275|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.275|0.151|<0.0001
71099778|NCT00452400|141708652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.214|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.151|0.277|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.277|0.151|<0.0001
71099779|NCT00452400|141708653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.097|0.231|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.231|0.097|<0.0001
70995313|NCT01763866|141499125|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.07|STANDARD_ERROR_OF_MEAN|4.85|<|0.001|TWO_SIDED|95.0|-34.64|-15.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-15.50|-34.64|<0.001
70995314|NCT01763866|141499125|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-19.79|STANDARD_ERROR_OF_MEAN|5.58||0.007|TWO_SIDED|95.0|-30.81|-8.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-8.77|-30.81|0.007
71099780|NCT00452400|141708653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.102|0.237|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.237|0.102|<0.0001
71099781|NCT00452400|141708653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.152|0.284|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.284|0.152|<0.0001
71099782|NCT00452400|141708653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.225|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.157|0.292|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.292|0.157|<0.0001
71099783|NCT00452400|141708654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.262|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.15|0.373|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.373|0.150|<0.0001
71099784|NCT00452400|141708654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.283|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.171|0.395|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.395|0.171|<0.0001
71099785|NCT00452400|141708654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.311|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|0.201|0.421|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.421|0.201|<0.0001
71099786|NCT00452400|141708654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.304|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.192|0.416|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.416|0.192|<0.0001
71099787|NCT00452400|141708655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.288|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.167|0.409|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.409|0.167|<0.0001
71040580|NCT00948792|141589640|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Wilcoxon (Mann-Whitney)|||"The null hypothesis is that there would be no difference in post-transfusion platelet counts (6-hour post-transfusion) between the two groups.~We opted to determine the number of transfusions that would be required to detect difference of 20,000 platelets/mm3 (with a standard deviation of 20,000). The number shown to demonstrate this was 44."||||0.26
71040581|NCT00948792|141589641|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Wilcoxon (Mann-Whitney)|||"The null hypothesis is that there would be no difference in the change in post-transfusion platelet counts (30 minutes and 6 hours post-transfusion) between the two groups.~We opted to determine the number of transfusions that would be required to detect difference of 20,000 platelets/mm3 (with a standard deviation of 20,000). The number shown to demonstrate this was 44."||||0.09
71040582|NCT04640194|141589653|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.39|2.61|||||A hazard ratio \> 1 favours the alteplase dose group over standard of care alone.|Unadjusted Hazard Ratio: Cox proportional hazard model containing fixed effect for treatment. The confidence intervals was determined using the Wald method to determine the variance.||2.61|0.39|
71040583|NCT04640194|141589653|OTHER||Hazard Ratio (HR)|1.23|||||TWO_SIDED|95.0|0.46|3.27|||||A hazard ratio \> 1 favours the alteplase dose group over standard of care alone.|Adjusted Hazard Ratio: Cox proportional hazard model containing fixed effect for treatment,ventilation status at baseline and age. The confidence intervals was determined using the Wald method to determine the variance.||3.27|0.46|
71040584|NCT04640194|141589653|OTHER||Hazard Ratio (HR)|1.75|||||TWO_SIDED|95.0|0.73|4.15|||||A hazard ratio \> 1 favours the alteplase dose group over standard of care alone.|Unadjusted Hazard Ratio: Cox proportional hazard model containing fixed effect for treatment. The confidence intervals was determined using the Wald method to determine the variance.||4.15|0.73|
71040585|NCT04640194|141589653|OTHER||Hazard Ratio (HR)|2.04|||||TWO_SIDED|95.0|0.83|5.01|||||A hazard ratio \> 1 favours the alteplase dose group over standard of care alone.|Adjusted Hazard Ratio: Cox proportional hazard model containing fixed effect for treatment,ventilation status at baseline and age. The confidence intervals was determined using the Wald method to determine the variance.||5.01|0.83|
71040586|NCT04640194|141589653|OTHER||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.35|3.66|||||A hazard ratio \> 1 favours the alteplase dose group over standard of care alone.|Unadjusted Hazard Ratio: Cox proportional hazard model containing fixed effect for treatment. The confidence intervals was determined using the Wald method to determine the variance.||3.66|0.35|
71040587|NCT04640194|141589653|OTHER||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.33|4.22|||||A hazard ratio \> 1 favours the alteplase dose group over standard of care alone.|Adjusted Hazard Ratio: Cox proportional hazard model containing fixed effect for treatment,ventilation status at baseline and age. The confidence intervals was determined using the Wald method to determine the variance.||4.22|0.33|
71040588|NCT04640194|141589654|OTHER||Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|-10.892|24.8734|||||Chan and Zhang exact confidence interval.|||24.8734|-10.892|
70995315|NCT01763866|141499125|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-16.15|STANDARD_ERROR_OF_MEAN|4.61||0.005|TWO_SIDED|95.0|-25.27|-7.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-7.03|-25.27|0.005
70995316|NCT01763866|141499125|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-23.18|STANDARD_ERROR_OF_MEAN|4.52|<|0.001|TWO_SIDED|95.0|-32.11|-14.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-14.25|-32.11|<0.001
70995317|NCT01763866|141499125|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-23.21|STANDARD_ERROR_OF_MEAN|4.95|<|0.001|TWO_SIDED|95.0|-33.0|-13.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-13.43|-33.00|<0.001
70995318|NCT01763866|141499125|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.87|STANDARD_ERROR_OF_MEAN|5.43|<|0.001|TWO_SIDED|95.0|-43.6|-22.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-22.14|-43.60|<0.001
70995319|NCT01763866|141499126|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-14.47|STANDARD_ERROR_OF_MEAN|4.92||0.088|TWO_SIDED|95.0|-24.16|-4.78||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-4.78|-24.16|0.088
70995320|NCT01763866|141499126|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.47|STANDARD_ERROR_OF_MEAN|7.22||0.005|TWO_SIDED|95.0|-40.71|-12.24||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-12.24|-40.71|0.005
70995321|NCT01763866|141499126|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-1.54|STANDARD_ERROR_OF_MEAN|5.0||1|TWO_SIDED|95.0|-11.41|8.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||8.32|-11.41|1.00
70995322|NCT01763866|141499126|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-15.19|STANDARD_ERROR_OF_MEAN|7.21||0.056|TWO_SIDED|95.0|-29.4|-0.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-0.97|-29.40|0.056
70995323|NCT01763866|141499126|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-16.42|STANDARD_ERROR_OF_MEAN|5.39||0.073|TWO_SIDED|95.0|-27.05|-5.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-5.80|-27.05|0.073
70995324|NCT01763866|141499126|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-9.6|STANDARD_ERROR_OF_MEAN|6.13||0.027|TWO_SIDED|95.0|-21.68|2.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||2.48|-21.68|0.027
70995325|NCT01763866|141499126|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-1.78|STANDARD_ERROR_OF_MEAN|5.27||1|TWO_SIDED|95.0|-12.16|8.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||8.61|-12.16|1.00
70995326|NCT01763866|141499126|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|4.94|STANDARD_ERROR_OF_MEAN|6.18||0.62|TWO_SIDED|95.0|-7.25|17.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||17.14|-7.25|0.62
70995327|NCT01763866|141499126|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-21.98|STANDARD_ERROR_OF_MEAN|6.2|<|0.001|TWO_SIDED|95.0|-34.24|-9.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-9.73|-34.24|<0.001
70995328|NCT01763866|141499126|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-18.75|STANDARD_ERROR_OF_MEAN|6.5||0.007|TWO_SIDED|95.0|-31.6|-5.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-5.90|-31.60|0.007
71040589|NCT04640194|141589654|OTHER||Risk Difference (RD)|20.0|||||TWO_SIDED|95.0|2.3075|43.6615|||||Chan and Zhang exact confidence interval.|||43.6615|2.3075|
71040590|NCT04640194|141589654|OTHER||Risk Difference (RD)|11.76|||||TWO_SIDED|95.0|-24.127|36.9012|||||Chan and Zhang exact confidence interval.|||36.9012|-24.127|
71040591|NCT04640194|141589655|OTHER||Risk Difference (RD)|-16.6|||||TWO_SIDED|95.0|-38.6|5.5|||||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% confidence interval is based upon average marginal effect Delta method, adjusting for baseline ventilation status, age and treatment.||5.5|-38.6|
71040592|NCT04640194|141589655|OTHER||Risk Difference (RD)|-11.8|||||TWO_SIDED|95.0|-35.1|11.6|||||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% confidence interval is based upon average marginal effect Delta method, adjusting for baseline ventilation status, age and treatment.||11.6|-35.1|
70995329|NCT01763866|141499126|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-16.19|STANDARD_ERROR_OF_MEAN|5.7||0.005|TWO_SIDED|95.0|-27.46|-4.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-4.92|-27.46|0.005
71040593|NCT04640194|141589655|OTHER||Risk Difference (RD)|-19.1||||0.2419|TWO_SIDED|95.0|-51.1|12.9|||The delta method and average marginal.||Calculated as alteplase dose group - standard of care alone.|Unadjusted risk difference and 95% CI is based upon average marginal effect Delta method, adjusting for treatment.||12.9|-51.1|0.2419
71040594|NCT04640194|141589656|OTHER||Risk Difference (RD)|-9.0|||||TWO_SIDED|95.0|-37.1|19.1|||||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% confidence interval is based upon average marginal effect Delta method, adjusting for baseline ventilation status, age and treatment.||19.1|-37.1|
71099788|NCT00452400|141708655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001||95.0|0.159|0.401|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.401|0.159|<0.0001
71099789|NCT00452400|141708655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.297|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.178|0.416|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.416|0.178|<0.0001
71099790|NCT00452400|141708655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.286|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001||95.0|0.164|0.407|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.407|0.164|<0.0001
71099791|NCT00452400|141708656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.09|0.176|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.176|0.090|<0.0001
71099792|NCT00452400|141708656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.128|0.215|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.215|0.128|<0.0001
71099793|NCT00452400|141708656|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.162|0.247|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.247|0.162|<0.0001
71099794|NCT00452400|141708656|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.159|0.246|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.246|0.159|<0.0001
71099795|NCT00452400|141708657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.187|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.131|0.243|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.243|0.131|<0.0001
71099796|NCT00452400|141708657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.159|0.271|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.271|0.159|<0.0001
71099797|NCT00452400|141708657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.163|0.273|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.273|0.163|<0.0001
70995330|NCT01763866|141499126|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-18.54|STANDARD_ERROR_OF_MEAN|5.31|<|0.001|TWO_SIDED|95.0|-29.04|-8.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-8.05|-29.04|<0.001
71040595|NCT04640194|141589656|OTHER||Risk Difference (RD)|-9.1|||||TWO_SIDED|95.0|-37.2|19.0|||||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% confidence interval is based upon average marginal effect Delta method, adjusting for baseline ventilation status, age and treatment.||19.0|-37.2|
71040596|NCT04640194|141589656|OTHER||Risk Difference (RD)|14.5||||0.2523|TWO_SIDED|95.0|-10.3|39.3|||The delta method and average marginal.||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% CI is based upon average marginal effect Delta method, adjusting for baseline D-dimer status, age, days of NIV support and treatment.||39.3|-10.3|0.2523
71099798|NCT00452400|141708657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.247|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.191|0.304|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.304|0.191|<0.0001
71099799|NCT00452400|141708658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.1|0.219|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.219|0.100|<0.0001
71099800|NCT00452400|141708658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.194|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.134|0.253|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.253|0.134|<0.0001
71099801|NCT00452400|141708658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.144|0.262|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.262|0.144|<0.0001
71099802|NCT00452400|141708658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.145|0.264|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.264|0.145|<0.0001
70995331|NCT01763866|141499126|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.45|STANDARD_ERROR_OF_MEAN|5.39|<|0.001|TWO_SIDED|95.0|-33.09|-11.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-11.81|-33.09|<0.001
70995332|NCT01763866|141499126|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.83|STANDARD_ERROR_OF_MEAN|6.14|<|0.001|TWO_SIDED|95.0|-48.96|-24.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-24.70|-48.96|<0.001
70995333|NCT01763866|141499127|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|6.53|STANDARD_ERROR_OF_MEAN|1.84||0.034|TWO_SIDED|95.0|2.91|10.15||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||10.15|2.91|0.034
70995334|NCT01763866|141499127|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.11|STANDARD_ERROR_OF_MEAN|2.37||0.017|TWO_SIDED|95.0|3.43|12.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||12.79|3.43|0.017
70995335|NCT01763866|141499127|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|6.67|STANDARD_ERROR_OF_MEAN|1.86||0.001|TWO_SIDED|95.0|3.0|10.34||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||10.34|3.00|0.001
70995336|NCT01763866|141499127|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.57|STANDARD_ERROR_OF_MEAN|2.36||0.006|TWO_SIDED|95.0|3.93|13.22||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||13.22|3.93|0.006
70995337|NCT01763866|141499127|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|3.95|STANDARD_ERROR_OF_MEAN|2.1||0.85|TWO_SIDED|95.0|-0.19|8.09||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||8.09|-0.19|0.85
70995338|NCT01763866|141499127|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|9.13|STANDARD_ERROR_OF_MEAN|2.26|<|0.001|TWO_SIDED|95.0|4.68|13.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||13.58|4.68|<0.001
70995339|NCT01763866|141499127|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|7.57|STANDARD_ERROR_OF_MEAN|2.06||0.003|TWO_SIDED|95.0|3.51|11.64||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||11.64|3.51|0.003
70995340|NCT01763866|141499127|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.35|STANDARD_ERROR_OF_MEAN|2.28||0.003|TWO_SIDED|95.0|3.86|12.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||12.84|3.86|0.003
70995341|NCT01763866|141499127|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|5.36|STANDARD_ERROR_OF_MEAN|1.87|<|0.001|TWO_SIDED|95.0|1.68|9.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.04|1.68|<0.001
70995342|NCT01763866|141499127|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.66|STANDARD_ERROR_OF_MEAN|3.11||0.01|TWO_SIDED|95.0|2.51|14.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||14.80|2.51|0.010
70995343|NCT01763866|141499127|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|5.46|STANDARD_ERROR_OF_MEAN|1.91||0.013|TWO_SIDED|95.0|1.69|9.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.23|1.69|0.013
70995344|NCT01763866|141499127|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|6.75|STANDARD_ERROR_OF_MEAN|2.2||0.002|TWO_SIDED|95.0|2.4|11.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||11.10|2.40|0.002
70995345|NCT01763866|141499127|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|10.23|STANDARD_ERROR_OF_MEAN|2.58|<|0.001|TWO_SIDED|95.0|5.13|15.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||15.32|5.13|<0.001
70995346|NCT01763866|141499127|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.85|STANDARD_ERROR_OF_MEAN|2.09|<|0.001|TWO_SIDED|95.0|4.73|12.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||12.97|4.73|<0.001
70995347|NCT01763866|141499128|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|6.83|STANDARD_ERROR_OF_MEAN|2.11||0.034|TWO_SIDED|95.0|2.66|10.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||10.99|2.66|0.034
71040597|NCT04640194|141589657|OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-4.4|10.6|||||Calculated as alteplase dose group - standard of care alone.|Parameters included in model: treatment,ventilation status at baseline, and age.||10.6|-4.4|
71040598|NCT04640194|141589657|OTHER||Median Difference (Final Values)|4.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-3.2|11.8|||||Calculated as alteplase dose group - standard of care alone.|Parameters included in model: treatment,ventilation status at baseline, and age.||11.8|-3.2|
71040599|NCT04640194|141589658|OTHER||Risk Difference (RD)|-4.9|||||TWO_SIDED|95.0|-29.0|19.2|||||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% confidence interval is based upon average marginal effect Delta method, adjusting for baseline ventilation status, age and treatment.||19.2|-29.0|
71040600|NCT04640194|141589658|OTHER||Risk Difference (RD)|-15.2|||||TWO_SIDED|95.0|-36.8|6.3|||||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% confidence interval is based upon average marginal effect Delta method, adjusting for baseline ventilation status, age and treatment.||6.3|-36.8|
71040601|NCT04640194|141589659|OTHER||Median Difference (Net)|17.193|||||TWO_SIDED|95.0|-28.45|52.33|||||Calculated as alteplase dose group - standard of care alone.|Based upon Hedges-Lehmann estimator handling deaths as failure and Wilcoxon rank sum test methodology.||52.33|-28.45|
71040602|NCT04640194|141589659|OTHER||Median Difference (Final Values)|54.436|||||TWO_SIDED|95.0|0.49|110.36|||||Calculated as alteplase dose group - standard of care alone.|Based upon Hedges-Lehmann estimator handling deaths as failure and Wilcoxon rank sum test methodology.||110.36|0.49|
71040603|NCT04640194|141589661|OTHER||Median Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|3.6||0.9856|TWO_SIDED|95.0|-7.5|7.6|||ANCOVA||Calculated as alteplase dose group - standard of care alone.|Unadjusted mean difference: A restricted maximum likelihood (REML) based Analysis of Covariance (ANCOVA) was used. Adjustment was made for treatment.||7.6|-7.5|0.9856
71040604|NCT04640194|141589661|OTHER||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|3.8||0.8729|TWO_SIDED|95.0|-8.5|7.3|||ANCOVA||Calculated as alteplase dose group - standard of care alone.|Adjusted mean difference: A restricted maximum likelihood (REML) based Analysis of Covariance (ANCOVA) was used. Adjustment was made for treatment, the number of days under NIV support, baseline D-Dimer level and age.||7.3|-8.5|0.8729
71040605|NCT04640194|141589662|OTHER||Mean Difference (Net)|70.9|STANDARD_ERROR_OF_MEAN|35.8||0.0603|TWO_SIDED|95.0|-3.3|145.1|||ANCOVA||Calculated as alteplase dose group - standard of care alone.|Unadjusted mean difference: A restricted maximum likelihood (REML) based Analysis of Covariance (ANCOVA) was used. Adjustment was made for treatment.||145.1|-3.3|0.0603
70995348|NCT01763866|141499128|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|7.87|STANDARD_ERROR_OF_MEAN|2.46||0.017|TWO_SIDED|95.0|3.01|12.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||12.73|3.01|0.017
70995349|NCT01763866|141499128|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.81|STANDARD_ERROR_OF_MEAN|2.14||0.001|TWO_SIDED|95.0|4.58|13.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||13.03|4.58|0.001
71099803|NCT00452400|141708659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.101|0.209|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.209|0.101|<0.0001
71099804|NCT00452400|141708659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.131|0.239|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.239|0.131|<0.0001
71099805|NCT00452400|141708659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.231|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.178|0.284|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.284|0.178|<0.0001
71099806|NCT00452400|141708659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.231|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.177|0.286|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.286|0.177|<0.0001
71099807|NCT00452400|141708660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.202|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.14|0.264|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.264|0.140|<0.0001
71099808|NCT00452400|141708660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.231|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.169|0.294|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.294|0.169|<0.0001
71099809|NCT00452400|141708660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.233|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.172|0.295|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.295|0.172|<0.0001
71099810|NCT00452400|141708660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.259|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.197|0.322|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.322|0.197|<0.0001
71099811|NCT00452400|141708661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.101|0.228|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.228|0.101|<0.0001
71099812|NCT00452400|141708661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.189|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.125|0.252|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.252|0.125|<0.0001
71099813|NCT00452400|141708661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.14|0.266|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.266|0.140|<0.0001
71099814|NCT00452400|141708661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.201|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.137|0.265|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.265|0.137|<0.0001
71099815|NCT00452400|141708662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.039||0.2392||95.0|-0.03|0.121|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.121|-0.030|0.2392
71099816|NCT00452400|141708662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.038||0.0001||95.0|0.072|0.222|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.222|0.072|0.0001
71099817|NCT00452400|141708662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.099|0.253|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.253|0.099|<0.0001
71099818|NCT00452400|141708662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.039||0.0001||95.0|0.076|0.228|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.228|0.076|0.0001
71099819|NCT00452400|141708663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.039||0.0309||95.0|0.008|0.162|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.162|0.008|0.0309
71099820|NCT00452400|141708663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.098|0.25|||ANCOVA||Olo 2 mcg qd minus Placebo|||0.250|0.098|<0.0001
71099821|NCT00452400|141708663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.04||0.0002||95.0|0.072|0.228|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.228|0.072|0.0002
70995350|NCT01763866|141499128|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.28|STANDARD_ERROR_OF_MEAN|2.45||0.006|TWO_SIDED|95.0|3.46|13.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||13.11|3.46|0.006
70995351|NCT01763866|141499128|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|4.07|STANDARD_ERROR_OF_MEAN|2.28||0.85|TWO_SIDED|95.0|-0.42|8.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||8.57|-0.42|0.85
70995352|NCT01763866|141499128|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|7.05|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|2.22|11.89||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||11.89|2.22|<0.001
70995353|NCT01763866|141499128|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.47|STANDARD_ERROR_OF_MEAN|2.23||0.003|TWO_SIDED|95.0|4.07|12.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||12.87|4.07|0.003
70995354|NCT01763866|141499128|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|7.14|STANDARD_ERROR_OF_MEAN|2.46||0.003|TWO_SIDED|95.0|2.29|11.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||11.99|2.29|0.003
71099822|NCT00452400|141708663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.039||0.0006||95.0|0.059|0.214|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.214|0.059|0.0006
71099823|NCT00452400|141708664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.043||0.215||95.0|-0.031|0.137|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.137|-0.031|0.2150
71099824|NCT00452400|141708664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.042||0.0024||95.0|0.046|0.212|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.212|0.046|0.0024
70995355|NCT01763866|141499128|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|3.2|STANDARD_ERROR_OF_MEAN|2.3|<|0.001|TWO_SIDED|95.0|-1.33|7.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||7.73|-1.33|<0.001
70995356|NCT01763866|141499128|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|7.35|STANDARD_ERROR_OF_MEAN|3.23||0.01|TWO_SIDED|95.0|0.97|13.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||13.72|0.97|0.010
70995357|NCT01763866|141499128|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|5.04|STANDARD_ERROR_OF_MEAN|2.29||0.013|TWO_SIDED|95.0|0.52|9.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.56|0.52|0.013
71099825|NCT00452400|141708664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.043||0.023||95.0|0.014|0.184|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.184|0.014|0.0230
71099826|NCT00452400|141708664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.043||0.0333||95.0|0.007|0.177|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.177|0.007|0.0333
71099827|NCT00452400|141708665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.043||0.2158||95.0|-0.031|0.137|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.137|-0.031|0.2158
70995358|NCT01763866|141499128|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|4.84|STANDARD_ERROR_OF_MEAN|2.41||0.002|TWO_SIDED|95.0|0.07|9.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.60|0.07|0.002
70995359|NCT01763866|141499128|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|9.78|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|4.05|15.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||15.51|4.05|<0.001
71099828|NCT00452400|141708665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.042||0.0024||95.0|0.046|0.212|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.212|0.046|0.0024
71099829|NCT00452400|141708665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.043||0.0013||95.0|0.055|0.225|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.225|0.055|0.0013
71099830|NCT00452400|141708665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.043||0.0376||95.0|0.005|0.174|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.174|0.005|0.0376
71099831|NCT00452400|141708666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.705|STANDARD_ERROR_OF_MEAN|5.916||0.0211|TWO_SIDED|95.0|2.07|25.34|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||25.340|2.070|0.0211
71099832|NCT00452400|141708666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.285|STANDARD_ERROR_OF_MEAN|5.951||0.0004|TWO_SIDED|95.0|9.581|32.99|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||32.990|9.581|0.0004
71099833|NCT00452400|141708666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.077|STANDARD_ERROR_OF_MEAN|5.832|<|0.0001|TWO_SIDED|95.0|26.607|49.546|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||49.546|26.607|<.0001
71099834|NCT00452400|141708666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.063|STANDARD_ERROR_OF_MEAN|5.99||0.0001|TWO_SIDED|95.0|11.282|34.845|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||34.845|11.282|0.0001
71099835|NCT00452400|141708667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.446|STANDARD_ERROR_OF_MEAN|6.283||0.0973|TWO_SIDED|95.0|-1.911|22.803|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||22.803|-1.911|0.0973
71099836|NCT00452400|141708667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.333|STANDARD_ERROR_OF_MEAN|6.36||0.0005|TWO_SIDED|95.0|9.824|34.842|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||34.842|9.824|0.0005
71099837|NCT00452400|141708667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.232|STANDARD_ERROR_OF_MEAN|6.192|<|0.0001|TWO_SIDED|95.0|26.054|50.409|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||50.409|26.054|<.0001
71099838|NCT00452400|141708667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.408|STANDARD_ERROR_OF_MEAN|6.403|<|0.0001|TWO_SIDED|95.0|12.814|38.002|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||38.002|12.814|<.0001
71099839|NCT00452400|141708668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.364||0.1541|TWO_SIDED|95.0|-1.237|0.196|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.196|-1.237|0.1541
71099840|NCT00452400|141708668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.367||0.7065|TWO_SIDED|95.0|-0.583|0.859|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.859|-0.583|0.7065
71099841|NCT00452400|141708668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.964|STANDARD_ERROR_OF_MEAN|0.359||0.0076|TWO_SIDED|95.0|-1.671|-0.258|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||-0.258|-1.671|0.0076
71099842|NCT00452400|141708668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.414|STANDARD_ERROR_OF_MEAN|0.369||0.2626|TWO_SIDED|95.0|-1.138|0.311|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.311|-1.138|0.2626
71099843|NCT03378635|141708712|SUPERIORITY||||||<|0.001|||||||Log Rank|||The treatment group difference between dasiglucagon and placebo was evaluated inferentially using a pairwise two-sided log rank test. Kaplan-Meier estimate with 95% CI, p-value based on treatment group difference between dasiglucagon and placebo using a two-sided log-rank test stratified by injection site. Treatment groups without censoring utilized a distribution free method to compute the confidence interval for median time.||||<0.001
70995360|NCT01763866|141499128|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|9.06|STANDARD_ERROR_OF_MEAN|2.36|<|0.001|TWO_SIDED|95.0|4.4|13.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||13.72|4.40|<0.001
70995361|NCT03245723|141499133|OTHER|Descriptive statistics||||||0.38|||||||Wilcoxon Rank Sum test|||||||0.38
70995362|NCT03245723|141499134|OTHER|Descriptive statistics||||||0.12|||||||Wilcoxon Rank Sum test|||||||0.12
70995363|NCT03337139|141499135|SUPERIORITY|||||||0.98||||||A priori threshold for statistical significance was p \<.05.|ANCOVA|||Comparing groups on 13 week weight loss, prior to randomization.||||.98
70995364|NCT03337139|141499135|SUPERIORITY|||||||0.75||||||A priori threshold for statistical significance was p \<.05.|ANCOVA|Controlling for Phase I weight loss||Comparing groups on 26 week weight loss||||.75
70995365|NCT03337139|141499135|SUPERIORITY|||||||0.02||||||A priori threshold for statistical significance was p\<.05.|ANCOVA|Controlling for Phase I weight loss||Comparing groups on 52 week weight loss||||.02
70995366|NCT03337139|141499136|SUPERIORITY|||||||0.12||||||A priori threshold for statistical significance was p \<.05.|ANCOVA|||Comparing groups on 13 week MVPA||||.12
70995367|NCT03337139|141499136|SUPERIORITY|||||||0.16||||||A priori threshold for statistical significance was p\<.05.|ANCOVA|Controlling for changes in Phase I MVPA||Comparing groups on 52 week MVPA||||.16
70995368|NCT03337139|141499137|SUPERIORITY|||||||0.43||||||A priori threshold for statistical significant was p\<.05.|Fisher Exact|||Comparing groups on 26 week retention rates||||.43
70995369|NCT03337139|141499137|SUPERIORITY|||||||0.48||||||A priori threshold for statistical significance was p\<.05.|Fisher Exact|||Comparing groups on 52 week retention rates.||||.48
70995370|NCT03337139|141499138|SUPERIORITY|||||||0.64||||||A priori threshold of statistical significance was p\<.05.|Permutation test|Permutation test (nonparametric test) was chosen due to the violation of t-test assumptions in the data set.||Comparing groups on phone calls completed in Phase II (52 weeks)||||.64
70995371|NCT03337139|141499138|SUPERIORITY|||||||0.499||||||A priori threshold for statistical significance was p\<.05.|Permutation test|Permutation test (nonparametric test) was chosen due to the violation of t-test assumptions in the data set.||Comparing groups on text messages completed in Phase II (52 weeks)||||.499
70995372|NCT03337139|141499139|SUPERIORITY|||||||0.86||||||A priori threshold for statistical significance was p\<.05.|Permutation test|Permutation test (nonparametric test) was chosen due to the violation of t-test assumptions in the data set.||Comparing groups on TAQ scores at 52 weeks||||.86
70995373|NCT03337139|141499140|SUPERIORITY|||||||0.002||||||A priori threshold for statistical significance was p\<.05.|ANCOVA|Controlling for Phase I engagement in self-monitoring||Comparing groups on percent days of self-monitoring of weight during Phase II||||.002
70995374|NCT03337139|141499140|SUPERIORITY|||||||0.001||||||A priori threshold for statistical significance was p\<.05.|ANCOVA|Controlling for Phase I engagement in self-monitoring||Comparing groups on percent days of self-monitoring of eating during Phase II||||.001
70995375|NCT03337139|141499140|SUPERIORITY|||||||0.25||||||A priori threshold for statistical significance was p\<.05.|ANCOVA|Controlling for Phase I engagement in self-monitoring||Comparing groups on percent days of self-monitoring of physical activity during Phase II||||.25
70995376|NCT03337139|141499141|SUPERIORITY|||||||0.005||||||A priori threshold for statistical significance was p\<.05.|ANCOVA|Controlling for Phase I perceived supportive accountability||Comparing groups on changes in perceived accountability during Phase II||||.005
70995377|NCT02554253|141499142|SUPERIORITY|Pilot study||||||0.23|||||||Fisher Exact|||Raw scores converted to z-scores using published references. Percentage of patients experiencing a decline of \> 1 standard deviation was compared between groups using Fisher's exact test. The outcome of postoperative cognitive dysfunction (POCD) was defined a-priori as a decline of decline of \>1 standard deviation (i.e. z-score decline of \> 1) on at least 2 neurocognitive tests and was compared between groups using Fisher's exact test.||||0.23
70995378|NCT02554253|141499143|SUPERIORITY|||||||0.08|||||||Fisher Exact|||||||0.08
70995379|NCT02554253|141499144|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||0.31
70995380|NCT01998269|141499166|SUPERIORITY_OR_OTHER||correlation coefficient|0.6|||<|0.001|TWO_SIDED||||||Correlation||r= 0.60, p-value\<0.001. P values below 0.05 are considered statistically significant in this study.|We examined correlations between patient scores on the Measure of Medication Self-Management (MeDS) and the 8-item Morisky Medication Adherence questionnaire.||||<.001
70995381|NCT02559206|141499173|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.569||||0.0839|TWO_SIDED|95.0|-1.214|0.076|||mixed model repeated measures (MMRM)|||||0.076|-1.214|0.0839
70995382|NCT02559206|141499173|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.297||||0.3661|TWO_SIDED|95.0|-0.942|0.348|||MMRM|||||0.348|-0.942|0.3661
70995383|NCT02559206|141499173|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.286||||0.3869|TWO_SIDED|95.0|-0.936|0.363|||MMRM|||||0.363|-0.936|0.3869
70995384|NCT02559206|141499173|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.771||||0.0199|TWO_SIDED|95.0|-1.419|-0.123|||MMRM|||||-0.123|-1.419|0.0199
70995385|NCT02559206|141499173|SUPERIORITY|||||||0.0276||||||Trend test performed using linear contrast statement for each DR formulation with placebo.|Trend Test|||||||0.0276
70995386|NCT02559206|141499174|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.569||||0.0839|TWO_SIDED|95.0|-1.214|0.076|||MMRM|||||0.076|-1.214|0.0839
70995387|NCT02559206|141499174|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.455||||0.1669|TWO_SIDED|95.0|-1.102|0.191|||MMRM|||||0.191|-1.102|0.1669
70995388|NCT02559206|141499174|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.299||||0.3637|TWO_SIDED|95.0|-0.947|0.348|||MMRM|||||0.348|-0.947|0.3637
70995389|NCT02559206|141499174|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.258||||0.4333|TWO_SIDED|95.0|-0.905|0.389|||MMRM|||||0.389|-0.905|0.4333
70995390|NCT02559206|141499174|SUPERIORITY|||||||0.5528||||||Trend test performed using linear contrast statement for each DR formulation with placebo.|Trend Test|||||||0.5528
70995391|NCT02559206|141499175|SUPERIORITY||LS Mean Difference (Lin-Placebo)|0.992||||0.011|TWO_SIDED|95.0|0.228|1.756|||MMRM|||||1.756|0.228|0.0110
70995392|NCT02559206|141499175|SUPERIORITY||LS Mean Difference (Lin-Placebo)|0.048||||0.9013|TWO_SIDED|95.0|-0.716|0.812|||MMRM|||||0.812|-0.716|0.9013
70995393|NCT02559206|141499175|SUPERIORITY||LS Mean Difference (Lin-Placebo)|0.299||||0.4447|TWO_SIDED|95.0|-0.469|1.067|||MMRM|||||1.067|-0.469|0.4447
70995394|NCT02559206|141499175|SUPERIORITY||LS Mean Difference (Lin-Placebo)|0.662||||0.0904|TWO_SIDED|95.0|-0.104|1.428|||MMRM|||||1.428|-0.104|0.0904
70995395|NCT02559206|141499175|SUPERIORITY|||||||0.07||||||Trend test performed using linear contrast statement for each DR formulation with placebo.|Trend Test|||||||0.0700
70995396|NCT02559206|141499176|SUPERIORITY||LS Mean Difference (Lin-Placebo)|0.992||||0.011|TWO_SIDED|95.0|0.228|1.756|||MMRM|||||1.756|0.228|0.0110
70995397|NCT02559206|141499176|SUPERIORITY||LS Mean Difference (Lin-Placebo)|0.161||||0.6801|TWO_SIDED|95.0|-0.604|0.925|||MMRM|||||0.925|-0.604|0.6801
70995398|NCT02559206|141499176|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.095||||0.8069|TWO_SIDED|95.0|-0.861|0.67|||MMRM|||||0.670|-0.861|0.8069
70995399|NCT02559206|141499176|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.246||||0.5275|TWO_SIDED|95.0|-1.011|0.519|||MMRM|||||0.519|-1.011|0.5275
70995400|NCT02559206|141499176|SUPERIORITY|||||||0.4201||||||Trend test performed using linear contrast statement for each DR formulation with placebo.|Trend Test|||||||0.4201
70995401|NCT02559206|141499177|SUPERIORITY||Odds Ratio (OR)|1.71||||0.1663|TWO_SIDED|95.0|0.79|3.7|||Cochran-Mantel-Haenszel|||||3.70|0.79|0.1663
70995402|NCT02559206|141499177|SUPERIORITY||Odds Ratio (OR)|1.39||||0.4399|TWO_SIDED|95.0|0.61|3.17|||Cochran-Mantel-Haenszel|||||3.17|0.61|0.4399
70995403|NCT02559206|141499177|SUPERIORITY||Odds Ratio (OR)|1.27||||0.554|TWO_SIDED|95.0|0.57|2.85|||Cochran-Mantel-Haenszel|||||2.85|0.57|0.5540
70995404|NCT02559206|141499177|SUPERIORITY||Odds Ratio (OR)|2.39||||0.0262|TWO_SIDED|95.0|1.1|5.19|||Cochran-Mantel-Haenszel|||||5.19|1.10|0.0262
70995405|NCT02559206|141499177|SUPERIORITY|||||||0.0249||||||For each DR formulation, the Correlation Test p-values are obtained from the correlation statistic controlling for geographic region.|Correlation test|||||||0.0249
70995406|NCT02559206|141499178|SUPERIORITY||Odds Ratio (OR)|1.71||||0.1663|TWO_SIDED|95.0|0.79|3.7|||Cochran-Mantel-Haenszel|||||3.70|0.79|0.1663
70995407|NCT02559206|141499178|SUPERIORITY||Odds Ratio (OR)|1.13||||0.771|TWO_SIDED|95.0|0.49|2.58|||Cochran-Mantel-Haenszel|||||2.58|0.49|0.7710
70995408|NCT02559206|141499178|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8021|TWO_SIDED|95.0|0.48|2.58|||Cochran-Mantel-Haenszel|||||2.58|0.48|0.8021
70995409|NCT02559206|141499178|SUPERIORITY||Odds Ratio (OR)|0.89||||0.8011|TWO_SIDED|95.0|0.37|2.14|||Cochran-Mantel-Haenszel|||||2.14|0.37|0.8011
70995410|NCT02559206|141499178|SUPERIORITY|||||||0.8578||||||For each DR formulation, the Correlation Test p-values are obtained from the correlation statistic controlling for geographic region.|Correlation test|||||||0.8578
70995411|NCT04656418|141499190|OTHER|Test for differences|||||<|0.001||||||Compared the time-normalized number of HAE attacks in the active and placebo arms by using a two-sided Wilcoxon test (Hierarchical Testing H01) at alpha = 5%.|Two-sided Wilcoxon test|||||||<0.001
70995412|NCT04656418|141499191|OTHER|Test for differences|||||<|0.001||||||Compared the time-normalized number of HAE attacks in the active and placebo arms by using a two-sided Wilcoxon test.|Two-sided Wilcoxon test|||6 Months of treatment||||<0.001
71040606|NCT04640194|141589662|OTHER||Mean Difference (Final Values)|87.2|STANDARD_ERROR_OF_MEAN|38.5||0.0362|TWO_SIDED|95.0|6.3|168.0|||ANCOVA||Calculated as alteplase dose group - standard of care alone.|Adjusted mean difference: A restricted maximum likelihood (REML) based Analysis of Covariance (ANCOVA) was used. Adjustment was made for treatment, the number of days under NIV support, baseline D-Dimer level, baseline PaO2/FiO2 ratio and age.||168.0|6.3|0.0362
70995413|NCT04656418|141499192|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||6 Months of treatment||||<0.001
70995414|NCT04656418|141499192|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||First 3-months of treatment||||<0.001
70995415|NCT04656418|141499192|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||Second 3-months of treatment||||<0.001
70995416|NCT04656418|141499193|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||6 Months of treatment||||<0.001
70995417|NCT04656418|141499193|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||First 3-months of treatment||||<0.001
70995418|NCT04656418|141499193|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||Second 3-months of treatment||||<0.001
70995419|NCT04656418|141499194|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||First 3-months of treatment||||<0.001
70995420|NCT04656418|141499194|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||Second 3-months of treatment||||<0.001
70995421|NCT04656418|141499195|OTHER|Test for differences|||||<|0.001||||||Compared the time-normalized number of HAE attacks in the active and placebo arms by using a two-sided Wilcoxon test (Hierarchical testing H02) at alpha = 5%.|Two-sided Wilcoxon test|||||||<0.001
70995422|NCT00751179|141499286|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Significance level was set at 0.05.|ANOVA|||Treatment comparison was between the change from baseline in potassium level post-rocuronium dose versus post-succinylcholine dose, using a one way ANOVA model, with treatment as the term in the model.||||<0.0001
70995423|NCT00751179|141499287|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Significance level was set at 0.05.|ANOVA|||Treatment comparison was between the change from baseline in potassium level post-rocuronium dose versus post-succinylcholine dose, using a one way ANOVA model, with treatment as the term in the model.||||<0.0001
70995424|NCT00751179|141499289|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Significance level was set at 0.05.|ANOVA|||Treatment comparison was between the change from baseline in potassium level post-rocuronium dose versus post-succinylcholine dose, using a one way ANOVA model, with treatment as the term in the model.||||<0.0001
70995425|NCT00751179|141499291|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Significance level was set at 0.05.|ANOVA|||Treatment comparison was between the change from baseline in potassium level post-rocuronium dose versus post-succinylcholine dose, using a one way ANOVA model, with treatment as the term in the model.||||<0.0001
70995426|NCT02678312|141499334|SUPERIORITY||Cox Proportional Hazard|1.0655||||0.7958|TWO_SIDED|95.0|0.6589|1.7232||The adjusted hazard ratio and the p-values are based on a Cox proportional hazard model, stratified by modified age group with treatment and NYHA/ROSS class group included as factor.|Cox Proportional Hazard|||||1.7232|0.6589|0.7958
70995427|NCT00225147|141499391|SUPERIORITY_OR_OTHER|||||||0.001|||||||Log Rank|||||||0.001
70995428|NCT00225147|141499391|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Log Rank|||||||<0.001
70995429|NCT00225147|141499392|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Log Rank|||||||0.040
70995430|NCT00225147|141499392|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Log Rank|||||||<0.001
70995431|NCT00868166|141499428|SUPERIORITY|||||||0.71|||||||Stratified Log-Rank Test|||||||0.71
70995432|NCT00868166|141499429|SUPERIORITY|||||||0.83|||||||Stratified Log-Rank Test|||||||0.83
70995433|NCT00868166|141499429|SUPERIORITY|||||||0.73|||||||Non-stratified Log-Rank Test|||||||0.73
70995434|NCT00868166|141499431|SUPERIORITY|||||||0.21|||||||Stratified Log-Rank Test|||||||0.21
70995435|NCT00868166|141499431|SUPERIORITY|||||||0.2|||||||Non-stratified Log-Rank Test|||||||0.20
70995436|NCT00868166|141499433|SUPERIORITY|||||||0.56|||||||Stratified Log-Rank Test|||||||0.56
70995437|NCT01784588|141499455|NON_INFERIORITY|Non-inferiority (NI) was demonstrated if the entire confidence interval was above -15% at 36 months. The sample size was estimated under the assumption that the proportion of subjects with treatment success is 85% for each of Solyx and Obtryx. For a (one-sided) type I error rate of 0.05, 194 subjects (97 per arm) are needed to have 90% power to demonstrate non-inferiority of Solyx with a NI margin of 15%.|Adjusted Difference in Percentages|-0.4|||||TWO_SIDED|90.0|-8.2|7.4||Non-inferiority was evaluated using a two-sided 90% confidence interval (CI) for the treatment difference (SIS minus TMUS). The CI was calculated based on the pooling of treatment differences across propensity score strata for a binary endpoint.||||Available Cases Only - Intent-to-Treat||7.4|-8.2|
70995438|NCT01784588|141499455|NON_INFERIORITY|Non-inferiority (NI) was demonstrated if the entire confidence interval was above -15% at 36 months. The sample size was estimated under the assumption that the proportion of subjects with treatment success is 85% for each of Solyx and Obtryx. For a (one-sided) type I error rate of 0.05, 194 subjects (97 per arm) are needed to have 90% power to demonstrate non-inferiority of Solyx with a NI margin of 15%.|Unadjusted Treatment Difference (%)|1.5|||||TWO_SIDED|90.0|-5.4|8.4||Non-inferiority was evaluated using a two-sided 90% confidence interval (CI) for the treatment difference (SIS minus TMUS). The CI was calculated based on the pooling of treatment differences across propensity score strata for a binary endpoint.||||Available Cases Only - Intent-to-Treat||8.4|-5.4|
70995439|NCT02307838|141499456|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.59||||0.0155|TWO_SIDED|95.0|-1.07|-0.11|||ANCOVA|||||-0.11|-1.07|0.0155
70995440|NCT01413542|141499473|SUPERIORITY_OR_OTHER||Estimate of Difference||||<|0.001|TWO_SIDED|||||Effect of ACE inhibition on FBF response to bradykinin (p\<0.001). Other comparisons: Effect of DPP4 inhibition on FBF response to bradykinin (p=0.89); Effect of ACE (p=0.16), DPP4 (p=0.82), or combined inhibition (p=0.35) on FBF response to sub P.|Mixed Models Analysis|"Effect of DPP4 inhibition on vasodilator response to GLP-1 (p=0.14) or BNP (p=0.85).~p\<0.05 threshold for statistical significance."||"Group 1: The effect of treatment (placebo, ACE or DPP4 inhibitor, or the combination) on vasodilator response to peptide, measured as forearm blood flow was determined.~Group 2: The effect of treatment (placebo, DPP4 inhibitor) on vasodilator response to peptide, measured as percent change in forearm blood flow was determined."||||<0.001
70995441|NCT01413542|141499474|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Effect of DPP4 inhibition on tPA release during sub P in women (p=0.02 vs. placebo).Effect of ACE inhibition on tPA release during sub P in women (p\<0.001); effect of DPP4 inhibition on tPA release during sub P and (p=0.001 vs. ACE inhibition alone).|Mixed Models Analysis|p\<0.05 threshold for statistical significance||||||0.02
70995442|NCT01413542|141499475|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|||||Effect of combined ACE and DPP4 inhibition on change in heart rate in response to max dose substance P (p=0.011 vs placebo; ).|Wilcoxon signed rank|p\<0.05 threshold for statistical significance.||||||0.011
70995443|NCT01413542|141499476|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|||||Effect of combined DPP4 and ACE inhibition on the change in the norepinephrine AV gradient during substance P as compared to treatment with placebo.|Wilcoxon signed rank|||||||0.05
70995444|NCT01413542|141499476|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED|||||Effect of combined DPP4 and ACE inhibition on the change in the norepinephrine AV gradient during substance P as compared to treatment with ACE inhibition alone (p=0.007).|Wilcoxon signed rank|||||||0.007
70995445|NCT01413542|141499477|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||Effect of intra-arterial GLP-1 on venous GLP-1 concentrations during placebo (p=0.01).|wilxocon signed rank test|||||||0.01
70995446|NCT01413542|141499477|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||Effect of intra-arterial GLP-1 on venous GLP-1 concentrations during sitagliptin (p=0.01).|Wilcoxon signed rank|||||||0.01
70995447|NCT01413542|141499477|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|||||Effect of DPP4 inhibition on venous GLP-1 levels at high dose of intra-arterial GLP-1 (p=0.04 vs. placebo).|Wilcoxon signed rank|||||||0.04
70995448|NCT02505542|141499478|SUPERIORITY||Odds Ratio (OR)|18.822|||<|0.001|TWO_SIDED|95.0|9.605|38.864||A fixed sequence testing procedure was used whereby the second test (CZP 200 mg Q4W vs PBO) was interpreted as statistically significant only if the first test (CZP 200 mg Q2W vs PBO) was significant at the 0.05 level as well.|Regression, Logistic|||Odds ratio (and corresponding p-value) resulted from a logistic regression model with factors for treatment, geographic region, and modified New York (mNY) classification for study participants who did not experience a flare. An odds ratio \> 1 indicates a study participant on CZP was more likely not to experience a flare than a study participant on placebo. Penalized maximum likelihood approach was used for logistic regression.||38.864|9.605|<0.001
70995449|NCT02505542|141499478|SUPERIORITY||Odds Ratio (OR)|14.069|||<|0.001|TWO_SIDED|95.0|7.395|27.955||A fixed sequence testing procedure was used whereby the second test (CZP 200 mg Q4W vs PBO) was interpreted as statistically significant only if the first test (CZP 200 mg Q2W vs PBO) was significant at the 0.05 level as well.|Regression, Logistic|||Odds ratio (and corresponding p-value) resulted from a logistic regression model with factors for treatment, geographic region, and modified New York (mNY) classification for study participants who did not experience a flare. An odds ratio \> 1 indicates a study participant on CZP was more likely not to experience a flare than a study participant on placebo. Penalized maximum likelihood approach was used for logistic regression.||27.955|7.395|<0.001
70995450|NCT02505542|141499482|OTHER||||||<|0.001|||||||Log Rank|||P-values were from stratified log-rank test comparing the Certolizumab pegol 200 mg Q2W Double-Blind (RS) group with the Placebo Double-Blind (RS) group (Geographic region and modified New York (mNY) classification were used as stratification factors).||||<0.001
70995451|NCT02505542|141499482|OTHER||||||<|0.001|||||||Log Rank|||P-values were from stratified log-rank test comparing the Certolizumab pegol 200 mg Q4W Double-Blind (RS) group with the Placebo Double-Blind (RS) group (Geographic region and modified New York (mNY) classification were used as stratification factors).||||<0.001
70995452|NCT02505542|141499484|SUPERIORITY||Odds Ratio (OR)|17.94|||<|0.001|TWO_SIDED|95.0|8.95|35.961|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and modified New York (mNY) classification.||35.961|8.950|<0.001
70995453|NCT02505542|141499484|SUPERIORITY||Odds Ratio (OR)|11.385|||<|0.001|TWO_SIDED|95.0|5.952|21.778|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and modified New York (mNY) classification.||21.778|5.952|<0.001
70995454|NCT02505542|141499484|SUPERIORITY||Odds Ratio (OR)|17.653|||<|0.001|TWO_SIDED|95.0|8.333|37.399|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and modified New York (mNY) classification.||37.399|8.333|<0.001
70995455|NCT02505542|141499484|SUPERIORITY||Odds Ratio (OR)|11.863|||<|0.001|TWO_SIDED|95.0|5.67|24.822|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and modified New York (mNY) classification.||24.822|5.670|<0.001
70995456|NCT02505542|141499485|SUPERIORITY||Odds Ratio (OR)|20.205|||<|0.001|TWO_SIDED|95.0|9.851|41.439|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||41.439|9.851|<0.001
71040607|NCT04773600|141589683|SUPERIORITY||Odds Ratio (OR)|3.19|||<|0.0001|TWO_SIDED|95.0|1.962|5.183|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|vIGA Success at Week 4||5.183|1.962|<0.0001
70995457|NCT02505542|141499485|SUPERIORITY||Odds Ratio (OR)|12.07|||<|0.001|TWO_SIDED|95.0|6.275|23.218|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||23.218|6.275|<0.001
70995458|NCT02505542|141499486|SUPERIORITY||Odds Ratio (OR)|20.891|||<|0.001|TWO_SIDED|95.0|10.21|42.744|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||42.744|10.210|<0.001
70995459|NCT02505542|141499486|SUPERIORITY||Odds Ratio (OR)|10.377|||<|0.001|TWO_SIDED|95.0|5.456|19.738|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||19.738|5.456|<0.001
70995460|NCT02505542|141499487|SUPERIORITY||Odds Ratio (OR)|16.9|||<|0.001|TWO_SIDED|95.0|8.211|34.785|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||34.785|8.211|<0.001
70995461|NCT02505542|141499487|SUPERIORITY||Odds Ratio (OR)|12.072|||<|0.001|TWO_SIDED|95.0|5.954|24.476|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||24.476|5.954|<0.001
70995462|NCT02505542|141499488|SUPERIORITY||Odds Ratio (OR)|17.082|||<|0.001|TWO_SIDED|95.0|8.561|34.085|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||34.085|8.561|<0.001
70995463|NCT02505542|141499488|SUPERIORITY||Odds Ratio (OR)|11.503|||<|0.001|TWO_SIDED|95.0|5.939|22.278|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||22.278|5.939|<0.001
70995464|NCT02505542|141499489|OTHER||LS Mean Difference vs Placebo|-1.42|STANDARD_ERROR_OF_MEAN|0.126|<|0.001|TWO_SIDED|95.0|-1.66|-1.17|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-1.17|-1.66|<0.001
70995465|NCT02505542|141499489|OTHER||LS Mean Difference vs Placebo|-1.21|STANDARD_ERROR_OF_MEAN|0.126|<|0.001|TWO_SIDED|95.0|-1.45|-0.96|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-0.96|-1.45|<0.001
70995466|NCT02505542|141499490|OTHER||LS Mean Difference vs Placebo|-2.46|STANDARD_ERROR_OF_MEAN|0.268|<|0.001|TWO_SIDED|95.0|-2.99|-1.94|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-1.94|-2.99|<0.001
70995467|NCT02505542|141499490|OTHER||LS Mean Difference vs Placebo|-2.24|STANDARD_ERROR_OF_MEAN|0.267|<|0.001|TWO_SIDED|95.0|-2.77|-1.72|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-1.72|-2.77|<0.001
70995468|NCT02505542|141499491|OTHER||LS Mean Difference vs Placebo|-1.57|STANDARD_ERROR_OF_MEAN|0.238|<|0.001|TWO_SIDED|95.0|-2.04|-1.11|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-1.11|-2.04|<0.001
70995469|NCT02505542|141499491|OTHER||LS Mean Difference vs Placebo|-1.43|STANDARD_ERROR_OF_MEAN|0.238|<|0.001|TWO_SIDED|95.0|-1.9|-0.96|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-0.96|-1.90|<0.001
70995470|NCT02505542|141499492|OTHER||LS Mean Difference vs Placebo|-0.2|STANDARD_ERROR_OF_MEAN|0.112|=|0.074|TWO_SIDED|95.0|-0.42|0.02|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||0.02|-0.42|=0.074
70995471|NCT02505542|141499492|OTHER||LS Mean Difference vs Placebo|-0.24|STANDARD_ERROR_OF_MEAN|0.113|=|0.036|TWO_SIDED|95.0|-0.46|-0.02|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-0.02|-0.46|=0.036
70995472|NCT02505542|141499493|SUPERIORITY||Odds Ratio (OR)|18.308|||<|0.001|TWO_SIDED|95.0|9.084|36.898|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||36.898|9.084|<0.001
70995473|NCT02505542|141499493|SUPERIORITY||Odds Ratio (OR)|12.02|||<|0.001|TWO_SIDED|95.0|6.255|23.098|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||23.098|6.255|<0.001
71099844|NCT03378635|141708713|SUPERIORITY||||||<|0.001||||||p-value was \<0.001 at all time points (10, 15, 20 and 30 minutes)|Fisher Exact|||Pairwise test of independent binomial proportions with Fisher's Exact test comparing dasiglucagon versus placebo. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.001
71099845|NCT03378635|141708714|SUPERIORITY||||||<|0.001||||||The p-value was \<0.001 at all time points (10, 15, 20 and 30 minutes)|ANCOVA|||Plasma glucose (PG) change from baseline at rescue was carried forward in patients who required rescue intravenous (IV) glucose before reaching PG recovery. Change from baseline was analyzed using an ANCOVA, with treatment group as fixed effect and baseline PG as covariate. Group difference was evaluated inferentially following an a priori defined hierarchical test order, proceeding until the first failure to reject the null hypothesis.||||<0.001
71099846|NCT03378635|141708715|SUPERIORITY||||||<|0.001|||||||Log Rank|||The treatment group difference between dasiglucagon and placebo was evaluated using a Kaplan-Meier estimate with 95% confidence interval, p-value based on a pairwise two-sided log-rank test versus placebo.||||<0.001
71099847|NCT03378635|141708716|SUPERIORITY||Mean Difference (Net)|0.131|||<|0.001|TWO_SIDED|95.0|0.1|0.171|||ANCOVA|||The log-transformed AUC endpoint was analyzed using an analysis of covariance model with treatment as fixed effect and baseline plasma glucose modeled as a covariate. The least squares means treatment group differences were back-transformed (anti-logged) for presentation as a ratio of the treatment group geometric means, with their corresponding 95% confidence interval.||0.171|0.1|<0.001
70995474|NCT02505542|141499494|OTHER||LS Mean Difference vs Placebo|-1.0|STANDARD_ERROR_OF_MEAN|0.76|=|0.195|TWO_SIDED|95.0|-2.5|0.51|||ANCOVA|||"Only MRIs performed ± 2 weeks around the Week 96 or Early Withdrawal Visit were assigned to Week 96 or Early Withdrawal.~Only results of the double-read assessments of the central MRI review were included. The analysis used the average of the scores from the 2 independent reviewers. Whenever an adjudication was present, the average score across all 3 reviewers was used.~ANCOVA model with treatment, geographical region, mNY classification, and Part B Baseline as covariates."||0.51|-2.50|=0.195
70995475|NCT02505542|141499494|OTHER||LS Mean Difference vs Placebo|-0.6|STANDARD_ERROR_OF_MEAN|0.76|=|0.432|TWO_SIDED|95.0|-2.11|0.91|||ANCOVA|||"Only MRIs performed ± 2 weeks around the Week 96 or Early Withdrawal Visit were assigned to Week 96 or Early Withdrawal.~Only results of the double-read assessments of the central MRI review were included. The analysis used the average of the scores from the 2 independent reviewers. Whenever an adjudication was present, the average score across all 3 reviewers was used.~ANCOVA model with treatment, geographical region, mNY classification, and Part B Baseline as covariates."||0.91|-2.11|=0.432
71099848|NCT03378635|141708717|SUPERIORITY||Mean Difference (Net)|0.91||||0.144|TWO_SIDED|95.0|0.801|1.033|||ANCOVA|||Least square mean ratio for GlucaGen: dasiglucagon||1.033|0.801|0.144
71099849|NCT03378635|141708718|SUPERIORITY||Mean Difference (Net)|0.844||||0.006|TWO_SIDED|95.0|0.749|0.951|||ANCOVA|||Least square mean ratio for GlucaGen: dasiglucagon||0.951|0.749|0.006
70923529|NCT05568004|141338683|SUPERIORITY|||||||0.001||||||A p-value of \< 0.05 was considered statistically significant for all analyses.Two-tailed testing was used in nature of hypothesis testing.|ANOVA|p value for change over time within the group, Friedman 2-way ANOVA test was applied.|||Statistical analysis was conducted by a researcher using the Statistical Package for Social Sciences (SPSS) version 26.0. The Shapiro-Wilk test and histograms evaluated the data for normal distribution, and the Levene test confirmed homogeneous variances between groups (p \> 0.05). Continuous data following a normal distribution are presented as mean ± standard deviation (SD). The independent samples t test or Mann-Whitney U test was used to compare independent continuous data between groups, while the chi-square or Fisher's exact test was used to compare categorical data. Friedman two-way ANOVA was used to analyze dependent variables, while the two-way mixed ANOVA was used to examine the changes between groups over time. Before the two-way mixed ANOVA, boxplot evaluation confirmed no outliers. Mauchly's sphericity test showed that the assumption of sphericity for two-way interaction was met. Tukey's correction was used for pairwise subgroup comparisons.|||0.001
71040608|NCT04773600|141589684|SUPERIORITY||Odds Ratio (OR)|3.37|||<|0.0001|TWO_SIDED|95.0|1.996|5.687|||Cochran-Mantel-Haenszel|Stratified by pooled study site|Stratified by pooled study site|vIGA Success at Week 4 in Participants with Baseline vIGA = 'Moderate'||5.687|1.996|<0.0001
70923530|NCT05568004|141338683|SUPERIORITY|||||||0.001|||||||ANOVA|p value for change over time within the group, Friedman 2-way ANOVA test was applied.||A p-value of \< 0.05 was considered statistically significant for all analyses.Two-tailed testing was used in nature of hypothesis testing.||||0.001
70923531|NCT05568004|141338683|SUPERIORITY|||||||0.166||||||A p-value of \< 0.05 was considered statistically significant for all analyses.Two-tailed testing was used in nature of hypothesis testing.|ANOVA|p value for change over time within the group, Friedman 2-way ANOVA test was applied.||||||0.166
70923532|NCT05568004|141338684|SUPERIORITY|||||||0.074||||||A p-value of \< 0.05 was considered statistically significant for all analyses.Two-tailed testing was used in nature of hypothesis testing.|ANOVA|p value for change over time within the group, Friedman 2-way ANOVA test was applied.||Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time||||0.074
70923533|NCT05568004|141338684|SUPERIORITY|A p-value of \< 0.05 was considered statistically significant for all analyses.Two-tailed testing was used in nature of hypothesis testing.||||||0.074|||||||ANOVA|p value for change over time within the group, Friedman 2-way ANOVA test was applied.||||||0.074
70923534|NCT05568004|141338684|SUPERIORITY|||||||0.311||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|p value for change over time within the group, Friedman 2-way ANOVA test was applied.||||||0.311
70923535|NCT05568004|141338685|SUPERIORITY|||||||0.018||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time||||0.018
70923536|NCT05568004|141338685|SUPERIORITY|||||||0.152||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||0.152
70923537|NCT05568004|141338685|SUPERIORITY|||||||0.438||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied||||||0.438
70923538|NCT05568004|141338686|SUPERIORITY|||||||0.135||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied||Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time||||0.135
70923539|NCT05568004|141338686|SUPERIORITY|||||||0.203||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied||||||0.203
70995476|NCT02505542|141499495|OTHER||LS Mean Difference vs Placebo|-0.4|STANDARD_ERROR_OF_MEAN|0.19|=|0.04|TWO_SIDED|95.0|-0.78|-0.02|||ANCOVA|||"Only MRIs performed ± 2 weeks around the Week 96 or Early Withdrawal Visit were assigned to Week 96 or Early Withdrawal.~Only results of the double-read assessments of the central MRI review were included. The analysis used the average of the scores from the 2 independent reviewers. Whenever an adjudication was present, the average score across all 3 reviewers was used.~ANCOVA model with treatment, geographical region, mNY classification, and Part B Baseline as covariates."||-0.02|-0.78|=0.040
70995477|NCT02505542|141499495|OTHER||LS Mean Difference vs Placebo|-0.3|STANDARD_ERROR_OF_MEAN|0.19|=|0.074|TWO_SIDED|95.0|-0.73|0.03|||ANCOVA|||"Only MRIs performed ± 2 weeks around the Week 96 or Early Withdrawal Visit were assigned to Week 96 or Early Withdrawal.~Only results of the double-read assessments of the central MRI review were included. The analysis used the average of the scores from the 2 independent reviewers. Whenever an adjudication was present, the average score across all 3 reviewers was used.~ANCOVA model with treatment, geographical region, mNY classification, and Part B Baseline as covariates."||0.03|-0.73|=0.074
70995478|NCT03372603|141499513|OTHER||Ratio|1.336|||||TWO_SIDED|90.0|0.965|1.847|||||Treatment comparison ratio of GSK2798745 and placebo using posterior median ratio and 90% credible interval is presented.|||1.847|0.965|
70995479|NCT02806947|141499532|OTHER|No formal hypothesis test was planned or performed for comparing Day 28 CR/PR proportions between arms. Rather, the risk difference is estimated by a point estimate and 90% confidence interval.|Risk Difference (RD)|-0.082|STANDARD_ERROR_OF_MEAN|0.086|||TWO_SIDED|90.0|-0.223|0.059|||||The risk difference estimate is the observed proportion of Day 28 CR/PR in the sirolimus arm minus the proportion in the prednisone arm. A Wald confidence interval for this difference is given.|The primary objective of this Phase II trial was to describe the proportion of patients with Day 28 CR/PR in each treatment arm and to estimate the risk difference of these rates using a point estimate and 90% confidence interval. These estimates are used to inform about the efficacy of sirolimus in contrast to prednisone for potential future research.||0.059|-0.223|
70995480|NCT02806947|141499532|OTHER|No formal hypothesis test was planned or performed for comparing Day 56 CR/PR proportions between arms. Rather, the risk difference is estimated by a point estimate and 95% confidence interval.|Risk Difference (RD)|-0.152|STANDARD_ERROR_OF_MEAN|0.083|||TWO_SIDED|95.0|-0.315|0.011|||||The risk difference estimate is the observed proportion of Day 56 CR/PR in the sirolimus arm minus the proportion in the prednisone arm. A Wald confidence interval for this difference is given.|A secondary objective of this Phase II trial was to describe the proportion of patients with Day 56 CR/PR in each treatment arm and to estimate the risk difference of these rates using a point estimate and 95% confidence interval. These estimates are used to inform about the efficacy of sirolimus in contrast to prednisone for potential future research.||0.011|-0.315|
70995481|NCT02806947|141499533|SUPERIORITY||||||<|0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Z test comparing binomial proportions|||The null hypothesis is that there is no difference in the proportions of participants with CR/PR and steroid dose of 0.25mg/kg/day or less at Day 28 post-randomization between the sirolimus and prednisone arms. These proportions were compared between treatment arms using a Z test of the difference of binomial proportions.||||< 0.001
70995482|NCT02806947|141499534|SUPERIORITY|||||||0.32||||||Statistical significance was determined using a pre-specified threshold of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in classification of acute GVHD response at Day 28 post-randomization between participants on the sirolimus and prednisone arms. These classifications were compared between treatment arms using Fisher's exact test, due to the presence of small numbers of participants in some categories.||||0.320
70995483|NCT02806947|141499534|SUPERIORITY|||||||0.014||||||Statistical significance was determined using a pre-specified threshold of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in classification of acute GVHD response at Day 56 post-randomization between participants on the sirolimus and prednisone arms. These classifications were compared between treatment arms using Fisher's exact test, due to the presence of small numbers of participants in some categories.||||0.014
71040609|NCT04773600|141589685|SUPERIORITY||Odds Ratio (OR)|4.42|||<|0.0001|TWO_SIDED|95.0|2.281|8.658|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|vIGA-AD Success at Week 2||8.658|2.281|<0.0001
70995484|NCT02806947|141499535|SUPERIORITY|||||||0.078||||||Statistical significance was determine using a pre-specified threshold of 0.05|Z test comparing binomial proportions|||The null hypothesis is that there is no difference in the proportions of participants with treatment failure at Day 28 post-randomization between the sirolimus and prednisone arms. These proportions were compared between treatment arms using a Z test of the difference of binomial proportions.||||0.078
70995485|NCT02806947|141499535|SUPERIORITY|||||||0.068||||||Statistical significance was determined using a pre-specified threshold of 0.05|Z test comparing binomial proportions|||The null hypothesis is that there is no difference in the proportions of participants with treatment failure at Day 56 post-randomization between the sirolimus and prednisone arms. These proportions were compared between treatment arms using a Z test of the difference of binomial proportions.||||0.068
70995486|NCT02806947|141499536|SUPERIORITY|||||||0.785||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference in the proportions of participants with overall survival between the sirolimus and prednisone arms during the 12 month period post-randomization. These proportions were compared between treatment arms using a log rank test.||||0.785
70995487|NCT02806947|141499537|SUPERIORITY|||||||0.34||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference in the proportions of participants with disease-free survival between the sirolimus and prednisone arms during the 12 month period post-randomization. These proportions were compared between treatment arms using a log rank test.||||0.340
70995488|NCT02806947|141499538|SUPERIORITY|||||||0.713||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference in the proportions of participants with event-free survival between the sirolimus and prednisone arms during the 12 month period post-randomization. These proportions were compared between treatment arms using a log rank test.||||0.713
70995489|NCT02806947|141499539|SUPERIORITY|||||||0.726||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test|||The null hypothesis is that there is no difference in the proportions of participants with non-relapse mortality between the sirolimus and prednisone arms during the 12 month period post-randomization, with malignancy relapse treated as a competing risk for non-relapse mortality. These proportions were compared between treatment arms using Gray's test.||||0.726
70995490|NCT02806947|141499540|SUPERIORITY|||||||0.402||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test|||The null hypothesis is that there is no difference in the proportions of participants with malignancy relapse between the sirolimus and prednisone arms during the 12 month period post-randomization, with death treated as a competing risk for malignancy relapse. These proportions were compared between treatment arms using Gray's test.||||0.402
70995491|NCT02806947|141499541|SUPERIORITY|||||||0.296||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test|||The null hypothesis is that there is no difference in the proportions of participants with chronic GVHD between the sirolimus and prednisone arms during the 12 month period post-randomization, with death and malignancy relapse treated as competing risks for chronic GVHD. These proportions were compared between treatment arms using Gray's test.||||0.296
70995492|NCT02806947|141499542|SUPERIORITY|||||||0.936||||||Statistical significance was determined using a pre-specified threshold of 0.05|Z test comparing binomial proportions|||The null hypothesis is that there is no difference in the proportions of participants with GVHD-free survival at 6 months post-randomization between the sirolimus and prednisone arms. These proportions were compared between treatment arms using a Z test of the difference of binomial proportions.||||0.936
70995493|NCT02806947|141499542|SUPERIORITY|||||||0.598||||||Statistical significance was determined using a pre-specified threshold of 0.05|Z test comparing binomial proportions|||The null hypothesis is that there is no difference in the proportions of participants with GVHD-free survival at 6 months post-randomization between the sirolimus and prednisone arms. These proportions were compared between treatment arms using a Z test of the difference of binomial proportions.||||0.598
70995494|NCT02806947|141499543|SUPERIORITY|||||||0.221||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test|||The null hypothesis is that there is no difference in the proportions of participants with serious infections between the sirolimus and prednisone arms during the 12 month period post-randomization, with death treated as a competing risk for serious infection. These proportions were compared between treatment arms using Gray's test.||||0.221
70995495|NCT01978509|141499552|SUPERIORITY|||||||0.7|||||||ANOVA|||||||0.70
70995496|NCT00065442|141499561|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.775||||0.032|TWO_SIDED|95.0|0.614|0.979|||Regression, Cox|Cox regression model with treatment, PSA (ln), and LDH (ln) as the independent variables, stratified by randomization strata.|sipuleucel-T/placebo|||0.979|0.614|0.032
70995497|NCT00065442|141499561|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.766||||0.023|TWO_SIDED|95.0|0.608|0.965|||Log Rank|Stratified by randomization strata.|Cox regression model with treatment as the independent variable, stratified by randomization strata (sipuleucel-T/placebo)|||0.965|0.608|0.023
70995498|NCT00065442|141499562|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.951||||0.628|TWO_SIDED|95.0|0.773|1.169|||Log Rank|Stratified by randomization strata|Cox regression model with treatment as the independent variable, stratified by randomization strata|||1.169|0.773|0.628
71040610|NCT04773600|141589686|SUPERIORITY||Odds Ratio (OR)|1.99||||0.1156|TWO_SIDED|95.0|0.832|4.782|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|vIGA-AD Success at Week 1||4.782|0.832|0.1156
71040611|NCT04773600|141589687|SUPERIORITY||Odds Ratio (OR)|2.71||||0.0014|TWO_SIDED|95.0|1.448|5.066|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|≥4-Point Reduction in WI-NRS at Week 4||5.066|1.448|0.0014
71040612|NCT04773600|141589688|SUPERIORITY||Odds Ratio (OR)|3.55||||0.0015|TWO_SIDED|95.0|1.591|7.927|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|≥4-Point Reduction in WI-NRS at Week 2||7.927|1.591|0.0015
70923540|NCT05568004|141338686|SUPERIORITY|||||||0.593||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied||||||0.593
70995499|NCT01594333|141499566|SUPERIORITY||Cox Proportional Hazard|1.01||||0.91|TWO_SIDED|95.0|0.82|1.25||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time of qualifying event and risk status(diabetes or metabolic syndrome alone)|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.25|0.82|0.91
70995500|NCT01594333|141499567|SUPERIORITY||Cox Proportional Hazard|0.96||||0.67|TWO_SIDED|95.0|0.79|1.16||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time of qualifying event and risk status(metabolic syndrome alone or diabetes at enrollment).|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.16|0.79|0.67
71099850|NCT00562861|141708734|SUPERIORITY_OR_OTHER||F value|1.88||||0.17|TWO_SIDED||||||Mixed Models Analysis|||||||0.17
70995501|NCT01594333|141499568|SUPERIORITY||Cox Proportional Hazard|1.16||||0.32|TWO_SIDED|95.0|0.87|1.56||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time of qualifying event and risk status (metabolic syndrome alone or diabetes at enrollment).|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.56|0.87|0.32
71099851|NCT01694771|141708735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.09|0.144|||Mixed Model Repeated Measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (564), Tio+Olo 5ug (563).||0.144|0.090|<0.0001
71099852|NCT01694771|141708736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.037|0.088|||Mixed Model Repeated Measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (551), Tio+Olo 5ug (548).||0.088|0.037|<0.0001
71099853|NCT01694771|141708737|SUPERIORITY_OR_OTHER||Mean change from baseline|0.119|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.09|0.147|||Mixed model repeated measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (564), Tio+Olo 5ug (563).||0.147|0.090|<0.0001
71099854|NCT01694771|141708738|SUPERIORITY_OR_OTHER||Mean difference from Tio + Placebo|0.146|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.1|0.192|||Mixed model repeated measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (564), Tio+Olo 5ug (563).||0.192|0.100|<0.0001
71099855|NCT01694771|141708739|SUPERIORITY_OR_OTHER||Mean difference from Tio + Placebo|0.063|STANDARD_ERROR_OF_MEAN|0.022||0.0047|TWO_SIDED|95.0|0.019|0.106|||Mixed model repeated measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (551), Tio+Olo 5ug (548).||0.106|0.019|0.0047
71099856|NCT01694771|141708740|SUPERIORITY_OR_OTHER||Mean difference from Tio + Placebo|0.153|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.106|0.201|||Mixed model repeated measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (564), Tio+Olo 5ug (563).||0.201|0.106|<0.0001
71099857|NCT01694771|141708741|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|8.459|STANDARD_ERROR_OF_MEAN|2.192||0.0001|TWO_SIDED|95.0|4.159|12.759|||ANCOVA|||"Week 12: Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (561), Tio+Olo 5ug (557)."||12.759|4.159|0.0001
71099858|NCT01694771|141708742|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|-0.478|STANDARD_ERROR_OF_MEAN|0.116|<|0.0001|TWO_SIDED|95.0|-0.706|-0.25|||ANCOVA|||"Week 12: Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (561), Tio+Olo 5ug (557)."||-0.250|-0.706|<.0001
71099859|NCT01694771|141708743|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|-0.083|STANDARD_ERROR_OF_MEAN|0.041||0.0442|TWO_SIDED|95.0|-0.164|-0.002|||ANCOVA|||"Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (561), Tio+Olo 5ug (557)."||-0.002|-0.164|0.0442
71099860|NCT01694771|141708744|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|-0.393|STANDARD_ERROR_OF_MEAN|0.098|<|0.0001|TWO_SIDED|95.0|-0.586|-0.2|||ANCOVA|||"Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (561), Tio+Olo 5ug (557)."||-0.200|-0.586|<.0001
71099861|NCT00289900|141708751|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-13.2|||<|0.001|TWO_SIDED|95.0|-16.8|-9.6|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-9.6|-16.8|<0.001
71099862|NCT00289900|141708751|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.8|||<|0.001|TWO_SIDED|95.0|-13.8|-7.8|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-7.8|-13.8|<0.001
71099863|NCT00289900|141708751|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.1|||<|0.001|TWO_SIDED|95.0|-8.1|-2.1|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-2.1|-8.1|<0.001
70995502|NCT01594333|141499569|SUPERIORITY||Cox Proportional Hazard|0.95||||0.57|TWO_SIDED|95.0|0.81|1.12||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time of qualifying event and risk status (metabolic syndrome alone or diabetes) at enrollment.|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.12|0.81|0.57
70995503|NCT01594333|141499570|SUPERIORITY||Cox Proportional Hazard|0.89||||0.54|TWO_SIDED|95.0|0.6|1.31||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, type of qualifying event and risk status (diabetes or metabolic syndrome alone) at enrollment|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.31|0.60|0.54
70995504|NCT01594333|141499571|SUPERIORITY||Cox Proportional Hazard|0.98||||0.8|TWO_SIDED|95.0|0.84|1.14||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time since qualifying event and risk status (diabetes or metabolic syndrome alone) at enrollment.|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.14|0.84|0.80
70995505|NCT01594333|141499573|SUPERIORITY||Cox Proportional Hazard|0.81||||0.31|TWO_SIDED|95.0|0.53|1.22||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time of qualifying event and risk status (diabetes or metabolic syndrome alone) at enrollment.|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.22|0.53|0.31
70995506|NCT01594333|141499574|SUPERIORITY||Cox Proportional Hazard|0.92||||0.38|TWO_SIDED|95.0|0.75|1.12||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time of qualifying event and risk status (diabetes or metabolic syndrome alone) at enrollment|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.12|0.75|0.38
70995507|NCT01764256|141499579|EQUIVALENCE|Definition of equivalence: p\<0.05||||||0.44|||||||Fisher Exact|||Proportion of subjects with at least one unsolicited adverse event (related or unrelated)||||0.44
70995508|NCT01764256|141499579|EQUIVALENCE|Definition of equivalence: p\<0.05||||||0.7446|||||||Fisher Exact|||Proportion of subjects with at least one unsolicited adverse event: potentially related||||0.7446
70995509|NCT01764256|141499580|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||0.5694|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic or local reaction)||||0.5694
70995510|NCT01764256|141499580|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic reaction)||||1.0000
70995511|NCT01764256|141499580|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (local reaction)||||1.0000
70995512|NCT01764256|141499581|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||0.6004|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic or local reaction)||||0.6004
70995513|NCT01764256|141499581|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic reaction)||||1
70995514|NCT01764256|141499581|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (local reaction)||||1.00
71040613|NCT04773600|141589689|SUPERIORITY||Odds Ratio (OR)|7.84||||0.002|TWO_SIDED|95.0|1.717|35.764|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|≥4-Point Reduction in WI-NRS at Week 1||35.764|1.717|0.0020
71040614|NCT04773600|141589690|SUPERIORITY||Odds Ratio (OR)|3.23|||<|0.0001|TWO_SIDED|95.0|2.108|4.964|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|EASI-75 at Week 4||4.964|2.108|<0.0001
71040615|NCT04773600|141589691|SUPERIORITY||Odds Ratio (OR)|3.39|||<|0.0001|TWO_SIDED|95.0|2.191|5.24|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 4||5.240|2.191|<0.0001
70995515|NCT01764256|141499582|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic or local reaction)||||1.0000
70995516|NCT01764256|141499582|EQUIVALENCE|Equivalence defined as p\<0.05||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic)||||1.0000
70995517|NCT01764256|141499582|EQUIVALENCE|Equivalence was defined as p\<0.05||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (local reaction)||||1.0000
70995518|NCT01764256|141499583|EQUIVALENCE|Equivalence was defined as p\<0.05||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic or local reaction)||||1.0000
70995519|NCT01764256|141499583|EQUIVALENCE|Equivalence was defined as p\<0.05||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic)||||1.0000
70995520|NCT01764256|141499583|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (local reaction)||||1.0000
70995521|NCT02666508|141499613|OTHER|Test conducted was a test of difference between plaque identifying toothpaste and non-plaque identifying toothpaste for change in DPIA from pre to post.|Mean Difference (Net)|-1.02||||0.001|TWO_SIDED|95.0|-1.6|-0.44|||Repeated Measures ANOVA|||||-0.44|-1.60|0.001
71040616|NCT04773600|141589692|SUPERIORITY||Odds Ratio (OR)|3.5|||<|0.0001|TWO_SIDED|95.0|2.097|5.854|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 2||5.854|2.097|<0.0001
70995522|NCT02666508|141499614|OTHER|Test conducted was a test of the difference between plaque identifying toothpaste and non-plaque identifying toothpaste for change in hsCRP|Mean Difference (Net)|-0.18||||0.459|TWO_SIDED|95.0|-0.69|0.32|||Repeated Measures ANOVA|||||0.32|-0.69|0.459
70995523|NCT03428997|141499625|EQUIVALENCE|Mixed-effects model, where the test material/negative control is a fixed effect and the subject is a random effect|Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.11||0.274|||||||2-sided t-test|||Testing hypothesis is that the mean score is equal between the compared treatments.||||0.274
70995524|NCT00400712|141499629|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||ANCOVA|Examined whether there were differences between groups at 1 year with baseline measures serving as the covariate with a two-sided alpha of 0.05||||||0.44
70995525|NCT00400712|141499630|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|||||Examined whether there were differences between groups at 1 year with baseline measures serving as the covariate with a two-sided alpha of 0.05|ANCOVA|||||||0.83
70995526|NCT00400712|141499631|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||ANCOVA|||ANCOVA - comparing absolute measures and including baseline as co-variate||||0.45
70995527|NCT00400712|141499632|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||ANCOVA|adjusted for baseline values||||||0.72
70995528|NCT00400712|141499633|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||ANCOVA|controlled for baseline values||||||0.60
71099864|NCT00289900|141708751|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-4.2||||0.007|TWO_SIDED|95.0|-7.2|-1.2|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-1.2|-7.2|0.007
71099865|NCT00289900|141708752|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|19.9|||<|0.001|TWO_SIDED|95.0|17.2|22.6|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||22.6|17.2|<0.001
71099866|NCT00289900|141708752|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|21.3|||<|0.001|TWO_SIDED|95.0|19.0|23.6|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||23.6|19.0|<0.001
71099867|NCT00289900|141708752|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|22.1|||<|0.001|TWO_SIDED|95.0|19.8|24.4|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||24.4|19.8|<0.001
70995529|NCT00400712|141499634|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED|||||Examined whether there were differences between groups at 1 year with baseline measures serving as the covariate with a two-sided alpha of 0.05|ANCOVA|||||||0.66
71099868|NCT00289900|141708752|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|23.0|||<|0.001|TWO_SIDED|95.0|20.7|25.3|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||25.3|20.7|<0.001
71099869|NCT00289900|141708753|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-17.3|||<|0.001|TWO_SIDED|95.0|-21.2|-13.3|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free confidence interval (CI) based on Wilcoxon's rank sum test|||-13.3|-21.2|<0.001
70995530|NCT00400712|141499635|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED|||||Examined whether there were differences between groups at 1 year with baseline measures serving as the covariate with a two-sided alpha of 0.05|ANCOVA|||||||0.78
70995531|NCT02466412|141499636|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|63.9326|||||TWO_SIDED|95.0|49.6045|82.3991|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|"Geometric LS mean ratio (CHTP 1.1 M:mCC).~Expressed as %"|The objective of this study was to determine the point estimate and precision of the CHTP 1.1 M:mCC ratio for Cmax. Therefore, there was no statistical hypothesis to be tested for this objective.||82.3991|49.6045|
70995532|NCT02466412|141499637|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|60.0052|||||TWO_SIDED|95.0|44.9517|80.0997|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|"Geometric LS mean ratio (CHTP 1.1 M:mCC).~Expressed as %"|The objective of this study was to determine the point estimate and precision of the CHTP 1.1 M:mCC ratio for AUC(0-last). Therefore, there was no statistical hypothesis to be tested for this objective.||80.0997|44.9517|
71040617|NCT04773600|141589693|SUPERIORITY||Odds Ratio (OR)|2.56||||0.005|TWO_SIDED|95.0|1.312|4.993|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 1||4.993|1.312|0.0050
71099870|NCT00289900|141708753|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-15.5|||<|0.001|TWO_SIDED|95.0|-19.1|-11.9|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-11.9|-19.1|<0.001
70995533|NCT02553317|141499641|SUPERIORITY||||||=|0.0099||||||The resulting p-value was compared with a significance level of 5%.|Log Rank|||Time to platelet count response in the caplacizumab arm and placebo arm was compared by conducting a two-sided stratified log-rank test based on a KM analysis, with severity of neurological involvement (according to the Glasgow coma scale \[GCS\] category, stratification factor used in randomization: ≤12 / 13-15) as stratification factor.||||= 0.0099
70995534|NCT02553317|141499641|SUPERIORITY||Hazard Ratio (HR)|1.55|||||TWO_SIDED|95.0|1.095|2.195|||||The HR was estimated from a Cox proportional Hazards regression model.|Time to platelet count response was analyzed using a Cox proportional hazards regression model with time to platelet count response as dependent variable, and treatment group and GCS category as independent variables. The hazard (or platelet count normalization rate) ratio from the Cox model was reported along with 95% CI.||2.195|1.095|
70995535|NCT02553317|141499642|SUPERIORITY||||||<|0.0001||||||The resulting p-value was compared with a significance level of 5%.|Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel (CMH) test was conducted with adjustment for GCS category (stratification factor used in randomization).||||< 0.0001
70995536|NCT02553317|141499643|SUPERIORITY||||||=|0.0004||||||The resulting p-value was compared with a significance level of 5%.|Cochran-Mantel-Haenszel|||A CMH test was conducted with adjustment for GCS category (stratification factor used in randomization).||||= 0.0004
70995537|NCT02553317|141499644|SUPERIORITY||||||=|0.0572||||||The resulting p-value was compared with a significance level of 5%.|Cochran-Mantel-Haenszel|||A CMH test was conducted with adjustment for GCS category (stratification factor used in randomization).||||= 0.0572
70995538|NCT00115765|141499674|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.27||||0.011||95.0|1.06|1.52|||Regression, Cox|Model covariates were ECOG status, prior chemotherapy, metastatic organs, disease site, oxaliplatin dose \< 85 mg/m2, and oxaliplatin dose \> 100 mg/m2||||1.52|1.06|0.011
70995539|NCT00115765|141499675|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.43||||0.005||95.0|1.11|1.83|||Regression, Cox|Model covariates were ECOG status, prior chemotherapy, metastatic organs, disease site, oxaliplatin dose \< 85 mg/m2, and oxaliplatin dose \> 100 mg/m2||||1.83|1.11|0.005
70995540|NCT00115765|141499679|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.738||95.0|0.6|2.05|||Regression, Logistic|Model covariates were ECOG status, prior adjuvant chemotherapy, number of metastatic organs, and primary disease site||||2.05|0.60|0.738
70995541|NCT00115765|141499680|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.42||||0.257||95.0|0.77|2.62|||Regression, Cox|Model covariates were ECOG status, prior adjuvant chemotherapy, number of metastatic organs, and primary disease site||||2.62|0.77|0.257
70995542|NCT00115765|141499682|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.36||||||95.0|1.04|1.77||||||||1.77|1.04|
70995543|NCT00115765|141499683|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||||95.0|0.91|1.71||||||||1.71|0.91|
70995544|NCT00115765|141499684|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.89||||||95.0|1.3|2.75||||||||2.75|1.30|
70995545|NCT00115765|141499685|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||||95.0|0.67|1.54||||||||1.54|0.67|
70995546|NCT00115765|141499686|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||||95.0|0.61|2.66||||||||2.66|0.61|
70995547|NCT00115765|141499687|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||||95.0|0.28|1.67||||||||1.67|0.28|
70995548|NCT03956225|141499692|NON_INFERIORITY|Noninferiority in change from baseline in MGS was declared if the lower confidence limit (LCL) was greater than -5.|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.07|||ONE_SIDED|95.0|-2.2||||Mixed effects repeated measures||Standard Error of the Least Squares Mean is presented. Least squares mean difference (iLux minus LipiFlow). Lower Confidence Limit is presented.||||-2.2|
70995549|NCT04093258|141499693|NON_INFERIORITY|Non-inferiority will be concluded if the lower limit is above 0.67. Superiority will be concluded if the lower limit is above 1.0.|Odds Ratio (OR)|1.51|||||TWO_SIDED|95.0|0.33|6.85|||Generalized Linear Mixed Model Analysis|Finite-sample corrected Akaike's Information Criterion|Odds ratio was calculated as Test/Control|"The proportion of response (1) was analyzed using a generalized linear mixed model with a binary distribution and logit link function for all questions."||6.85|0.33|
70995550|NCT04093258|141499694|NON_INFERIORITY|Non-inferiority will be concluded if the lower limit is above 0.67. Superiority will be concluded if the lower limit is above 1.0.|Odds Ratio (OR)|0.34|||||TWO_SIDED|95.0|0.1|1.19|||Generalized Linear Mixed Model Analysis|Finite-sample corrected Akaike's Information Criterion|Odds ratio was calculated as Test over Control|"The proportion of response (1) was analyzed using a generalized linear mixed model with a binary distribution and logit link function for all questions."||1.19|0.10|
70995551|NCT04093258|141499695|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.|Least square mean difference|-5.98|STANDARD_ERROR_OF_MEAN|3.202|||TWO_SIDED|95.0|-12.48|0.52|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test minus Control|||0.52|-12.48|
70995552|NCT00594204|141499696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.78|||<|0.0001||95.0|2.97|7.68||p-values are obtained from a logistic regression model including the main effects of treatment and country|Regression, Logistic||Odds Ratios obtained from a logistic regression model including the main effects of treatment and country|||7.68|2.97|<0.0001
70995553|NCT00594204|141499697|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0|||<|0.0001||95.0|3.3|7.5||p-values obtained from a logistic regression model including the main effects of treatment and country|Regression, Logistic||Odds ratios obtained from a logistic regression model including the main effects of treatment and country|Week 12||7.5|3.3|<0.0001
70995554|NCT00594204|141499697|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.3|||<|0.0001||95.0|2.8|6.5||p-values obtained from a logistic regression model including the main effects of treatment and country|Regression, Logistic||Odds ratios obtained from a logistic regression model including the main effects of treatment and country|Week 24||6.5|2.8|<0.0001
70995555|NCT00594204|141499698|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.76|||<|0.0001||95.0|3.74|8.88|||Regression, Logistic|p-value are obtained from a logistic regression model including the main effects of treatment and country|Odds Ratios obtained from a logistic regression model including the main effects of treatment and country|||8.88|3.74|<0.0001
70995556|NCT01115738|141499703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.24||||0.188|TWO_SIDED|95.0|-10.98|55.47||P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||55.47|-10.98|0.188
70995557|NCT01115738|141499703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.93||||0.809|TWO_SIDED|95.0|-28.2|36.07||P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||36.07|-28.20|0.809
70995558|NCT01115738|141499704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.93||||0.37|TWO_SIDED|95.0|-20.26|54.12||P-value is for Baseline. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||54.12|-20.26|0.370
70995559|NCT01115738|141499704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.89||||0.052|TWO_SIDED|95.0|-0.29|72.06||P-value is for Baseline. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||72.06|-0.29|0.052
70995560|NCT01115738|141499704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.45||||0.703|TWO_SIDED|95.0|-39.55|58.45||P-value is for 2 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||58.45|-39.55|0.703
70995561|NCT01115738|141499704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.45||||0.823|TWO_SIDED|95.0|-42.53|53.44||P-value is for 2 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||53.44|-42.53|0.823
70995562|NCT01115738|141499704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.69||||0.054|TWO_SIDED|95.0|-0.47|57.84||P-value is for 24 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||57.84|-0.47|0.054
70995563|NCT01115738|141499704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.3||||0.436|TWO_SIDED|95.0|-17.29|39.9||P-value is for 24 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||39.90|-17.29|0.436
70995564|NCT01115738|141499704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.87||||0.463|TWO_SIDED|95.0|-14.96|32.71||P-value is for 72 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||32.71|-14.96|0.463
70923541|NCT05568004|141338687|SUPERIORITY|||||||0.001||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time||||0.001
70923542|NCT05568004|141338687|SUPERIORITY|||||||0.021||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||0.021
70995565|NCT01115738|141499704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.34||||0.777|TWO_SIDED|95.0|-26.62|19.94||P-value is for 72 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||19.94|-26.62|0.777
70923543|NCT05568004|141338687|SUPERIORITY|||||||0.081||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||0.081
70995566|NCT01115738|141499707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.31||||0.505|TWO_SIDED|95.0|-13.1|6.48||P-value is for Baseline. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||6.48|-13.10|0.505
70923544|NCT05568004|141338688|SUPERIORITY||||||<|0.001||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time||||<0.001
70923545|NCT05568004|141338688|SUPERIORITY||||||<|0.001||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||<0.001
70923546|NCT05568004|141338688|SUPERIORITY|||||||0.747||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||0.747
70923547|NCT05568004|141338689|SUPERIORITY|||||||0.001||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time||||0.001
70923548|NCT05568004|141338689|SUPERIORITY||||||<|0.001||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||<0.001
70923549|NCT05568004|141338689|SUPERIORITY|||||||0.05||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||0.05
70923550|NCT05919082|141338690|OTHER||Odds Ratio (OR)|1.4||||0.0438|TWO_SIDED|95.0|1.01|1.99|||Regression, Logistic||The odds ratio and p-value are obtained by logistic regression model, adjusted for baseline PGA. Wald CI was presented.|||1.99|1.01|0.0438
70923551|NCT05919082|141338691|OTHER||Odds Ratio (OR)|1.5||||0.0108|TWO_SIDED|95.0|1.1|2.12|||Regression, Logistic||The odds ratio and p-value were obtained by logistic regression model, adjusted for baseline PGA and baseline mPASI score. Wald CI was presented.|||2.12|1.10|0.0108
70923552|NCT05919082|141338692|OTHER||Odds Ratio (OR)|1.5||||0.0199|TWO_SIDED|95.0|1.07|2.19|||Regression, Logistic||The odds ratio and p-value were obtained by logistic regression model, adjusted for baseline PGA and baseline mPASI score. Wald CI was presented.|||2.19|1.07|0.0199
70923553|NCT06311084|141338733|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
70923554|NCT06311084|141338734|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
70923555|NCT06311084|141338735|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
70923556|NCT06311084|141338736|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
70923557|NCT06311084|141338737|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
70923558|NCT06311084|141338738|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
70923559|NCT06311084|141338739|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
70995567|NCT01115738|141499707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.23||||0.278|TWO_SIDED|95.0|-14.74|4.27||P-value is for Baseline. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||4.27|-14.74|0.278
70923560|NCT06311084|141338740|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
70995568|NCT01115738|141499707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.71||||0.749|TWO_SIDED|95.0|-19.44|14.02||P-value is for 2 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||14.02|-19.44|0.749
70923561|NCT06311084|141338741|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
70923562|NCT06311084|141338742|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
70995569|NCT01115738|141499707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.15||||0.89|TWO_SIDED|95.0|-15.24|17.53||P-value is for 2 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||17.53|-15.24|0.890
70995570|NCT01115738|141499707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.89||||0.223|TWO_SIDED|95.0|-18.02|4.24||P-value is for 6 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||4.24|-18.02|0.223
70995571|NCT01115738|141499707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.33||||0.808|TWO_SIDED|95.0|-9.44|12.1||P-value is for 6 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||12.10|-9.44|0.808
70995572|NCT01115738|141499707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.07||||0.049|TWO_SIDED|95.0|-20.11|-0.04||P-value is for 24 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||-0.04|-20.11|0.049
70995573|NCT01115738|141499707|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.99||||0.842|TWO_SIDED|95.0|-10.85|8.86||P-value is for 24 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||8.86|-10.85|0.842
70995574|NCT01115738|141499707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.03||||0.247|TWO_SIDED|95.0|-13.58|3.52||P-value is for 72 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||3.52|-13.58|0.247
70995575|NCT01115738|141499707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.942|TWO_SIDED|95.0|-8.09|8.71||P-value is for 72 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||8.71|-8.09|0.942
70995576|NCT01115738|141499710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.449||||0.8711|TWO_SIDED|95.0|-38.81|45.71|||ANOVA|||A linear ANOVA model with PRU values at baseline for clopidogrel treated participants as response and CYP2C19 metabolizer status as covariate of main interest.||45.71|-38.81|0.8711
70995577|NCT01115738|141499711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.714||||0.7875|TWO_SIDED|95.0|-72.78|55.36|||ANOVA|||A linear ANOVA model with PRU values of 6 hours post Prasugrel LD as response and treatment, CYP2C19 metabolizer status, interaction of treatment-by-CYP2C19 metabolizer status as fixed effects.||55.36|-72.78|0.7875
70995578|NCT01115738|141499711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.435||||0.8913|TWO_SIDED|95.0|-53.23|46.37|||ANOVA|||A linear ANOVA model with PRU values of 6 hours Post-Prasugrel LD as response and treatment, CYP2C19 metabolizer status, interaction of treatment-by-CYP2C19 metabolizer status as fixed effects.||46.37|-53.23|0.8913
70995579|NCT01115738|141499711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7||||0.6229|TWO_SIDED|95.0|-35.43|58.83|||ANOVA|||A linear ANOVA model with PRU values of 6 hours Post-Prasugrel LD as response and treatment, CYP2C19 metabolizer status, interaction of treatment-by-CYP2C19 metabolizer status as fixed effects.||58.83|-35.43|0.6229
70995580|NCT01669811|141499713|SUPERIORITY_OR_OTHER||Difference in proportions|23.8|||<|0.0001|TWO_SIDED|95.0|14.9|32.6||p-value is obtained using chi square method.|Chi-squared|95% CI is obtained using Newcombe-Wilson score method without continuity correction.||To evaluate the efficacy of D20 bid on healing of refractory RE in comparison with D20 qd||32.6|14.9|<0.0001
70923563|NCT06311084|141338743|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
70995581|NCT01669811|141499714|SUPERIORITY_OR_OTHER||Difference in proportions|32.8|||<|0.0001|TWO_SIDED|95.0|21.9|42.6||p-value is obtained using chi square method.|Chi-squared|95% CI is obtained using Newcombe-Wilson score method without continuity correction.||To evaluate the efficacy of D20 bid on healing of refractory RE in comparison with D20 qd||42.6|21.9|<0.0001
70995582|NCT01669811|141499715|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.1452|TWO_SIDED|95.0|0.91|1.83|||Log Rank|95% CI of the hazard ratio is obtained using Cox proportional hazards model including a factor of treatment group.||To evaluate the efficacy of D20 bid on gastroesophageal reflux disease (GERD) symptoms in comparison with D20 qd||1.83|0.91|0.1452
70995583|NCT01669811|141499716|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.46||||0.0837|TWO_SIDED|95.0|0.97|2.18|||Log Rank|95% CI of the hazard ratio is obtained using Cox proportional hazards model including a factor of treatment group.||To evaluate the efficacy of D20 bid on gastroesophageal reflux disease (GERD) symptoms in comparison with D20 qd||2.18|0.97|0.0837
70923564|NCT06311084|141338744|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
70923565|NCT06311084|141338745|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
70995584|NCT01669811|141499717|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.34||||0.2678|TWO_SIDED|95.0|0.8|2.26|||Log Rank|95% CI of the hazard ratio is obtained using Cox proportional hazards model including a factor of treatment group.||To evaluate the efficacy of D20 bid on gastroesophageal reflux disease (GERD) symptoms in comparison with D20 qd||2.26|0.80|0.2678
70995585|NCT01669811|141499718|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.6389|TWO_SIDED|95.0|0.62|2.12|||Log Rank|95% CI of the hazard ratio is obtained using Cox proportional hazards model including a factor of treatment group.||To evaluate the efficacy of D20 bid on gastroesophageal reflux disease (GERD) symptoms in comparison with D20 qd||2.12|0.62|0.6389
70995586|NCT01669811|141499719|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.38||||0.4485|TWO_SIDED|95.0|0.8|2.38|||Log Rank|95% CI of the hazard ratio is obtained using Cox proportional hazards model including a factor of treatment group.||To evaluate the efficacy of D20 bid on gastroesophageal reflux disease (GERD) symptoms in comparison with D20 qd||2.38|0.80|0.4485
70995587|NCT03097614|141499761|SUPERIORITY|||||||0.0001|TWO_SIDED||||||ANCOVA|||||||0.0001
70995588|NCT00074802|141499854|SUPERIORITY||Mean Difference (Net)|-5.43||||0.267|TWO_SIDED|95.0|-15.05|4.19|||Mixed Models Analysis|||||4.19|-15.05|.267
70995589|NCT00074802|141499855|SUPERIORITY|||||||0.018||||||Fisher's Exact Test used for analyses.|Fisher Exact|||Fisher's Exact Test used for analyses of responder status.||||.018
70995590|NCT00074802|141499855|SUPERIORITY|||||||0.034||||||Fisher's Exact Test used for analyses.|Fisher Exact|||Fisher's Exact Test used for analyses of remitter status.||||.034
70995591|NCT00074802|141499856|SUPERIORITY||Mean Difference (Net)|-3.21||||0.0005|TWO_SIDED|95.0|-5.02|-1.39|||Mixed Models Analysis|||||-1.39|-5.02|.0005
71099871|NCT00289900|141708753|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-10.3|||<|0.001|TWO_SIDED|95.0|-13.7|-7.0|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-7.0|-13.7|<0.001
71099872|NCT00289900|141708753|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-6.8|||<|0.001|TWO_SIDED|95.0|-10.2|-3.4|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-3.4|-10.2|<0.001
71099873|NCT00289900|141708754|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.1|||<|0.001|TWO_SIDED|95.0|-12.1|-6.0|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-6.0|-12.1|<0.001
71099874|NCT00289900|141708754|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.4|||<|0.001|TWO_SIDED|95.0|-8.0|-2.9|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-2.9|-8.0|<0.001
71099875|NCT00289900|141708754|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|0.4||||0.771|TWO_SIDED|95.0|-2.2|2.9|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||2.9|-2.2|0.771
71099876|NCT00289900|141708754|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|2.4||||0.065|TWO_SIDED|95.0|-0.2|5.0|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||5.0|-0.2|0.065
71099877|NCT00289900|141708755|SUPERIORITY_OR_OTHER||Difference in least Squares Mean|-6.8|||<|0.001|TWO_SIDED|95.0|-10.2|-3.5|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-3.5|-10.2|<0.001
71099878|NCT00289900|141708755|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-3.0||||0.037|TWO_SIDED|95.0|-5.8|-0.2|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-0.2|-5.8|0.037
71099879|NCT00289900|141708755|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|2.8||||0.047|TWO_SIDED|95.0|0.0|5.6|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||5.6|0.0|0.047
71099880|NCT00289900|141708755|SUPERIORITY_OR_OTHER||Difference in Least Sqaures Mean|4.7|||<|0.001|TWO_SIDED|95.0|2.0|7.5|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||7.5|2.0|<0.001
71099881|NCT00289900|141708756|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.2|||<|0.001|TWO_SIDED|95.0|-12.1|-6.3|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-6.3|-12.1|<0.001
70995592|NCT00074802|141499857|SUPERIORITY||Mean Difference (Net)|-5.61||||0.0775|TWO_SIDED|95.0|-11.84|0.62|||Mixed Models Analysis|||||0.62|-11.84|.0775
70995593|NCT00074802|141499858|SUPERIORITY||Mean Difference (Net)|-5.53||||0.0006|TWO_SIDED|95.0|-8.7|-2.35|||Mixed Models Analysis||Paroxetine+CBT \> Paroxetine alone in BFNE change.|||-2.35|-8.70|.0006
71099882|NCT00289900|141708756|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.2|||<|0.001|TWO_SIDED|95.0|-7.7|-2.8|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-2.8|-7.7|<0.001
71099883|NCT00289900|141708756|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.9||||0.476|TWO_SIDED|95.0|-3.3|1.5|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||1.5|-3.3|0.476
71099884|NCT00289900|141708756|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|0.2||||0.845|TWO_SIDED|95.0|-2.2|2.7|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||2.7|-2.2|0.845
71099885|NCT00289900|141708757|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|9.0|||<|0.001|TWO_SIDED|95.0|6.6|11.4|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||11.4|6.6|<0.001
71099886|NCT00289900|141708757|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|7.7|||<|0.001|TWO_SIDED|95.0|5.8|9.7|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||9.7|5.8|<0.001
70995594|NCT00074802|141499859|SUPERIORITY||Mean Difference (Net)|0.2||||0.871|TWO_SIDED|95.0|-2.16|2.55|||Mixed Models Analysis|||||2.55|-2.16|.871
71099887|NCT00289900|141708757|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|9.0|||<|0.001|TWO_SIDED|95.0|7.0|10.9|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||10.9|7.0|<0.001
71099888|NCT00289900|141708757|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|10.7|||<|0.001|TWO_SIDED|95.0|8.7|12.7|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||12.7|8.7|<0.001
71099889|NCT00289900|141708758|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-3.6||||0.003|TWO_SIDED|95.0|-6.0|-1.2|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-1.2|-6.0|0.003
71099890|NCT00289900|141708758|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.5||||0.595|TWO_SIDED|95.0|-2.5|1.5|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||1.5|-2.5|0.595
71099891|NCT00289900|141708758|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|4.2|||<|0.001|TWO_SIDED|95.0|2.2|6.2|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||6.2|2.2|<0.001
71099892|NCT00289900|141708758|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|6.1|||<|0.001|TWO_SIDED|95.0|4.1|8.1|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||8.1|4.1|<0.001
71099893|NCT00289900|141708759|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-18.8|||<|0.001|TWO_SIDED|95.0|-24.2|-14.2|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-14.2|-24.2|<0.001
71099894|NCT00289900|141708759|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-20.5|||<|0.001|TWO_SIDED|95.0|-25.0|-16.6|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-16.6|-25.0|<0.001
71099895|NCT00289900|141708759|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-23.9|||<|0.001|TWO_SIDED|95.0|-27.8|-19.4|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-19.4|-27.8|<0.001
70995595|NCT00074802|141499860|SUPERIORITY||Median Difference (Net)|0.41||||0.949|TWO_SIDED|95.0|-11.95|12.76|||Mixed Models Analysis|||||12.76|-11.95|.949
71099896|NCT00289900|141708759|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-24.6|||<|0.001|TWO_SIDED|95.0|-28.6|-20.0|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-20.0|-28.6|<0.001
71099897|NCT00289900|141708760|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.8||||0.5|TWO_SIDED|95.0|-9.6|7.5|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||7.5|-9.6|0.500
71099898|NCT00289900|141708760|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|6.9||||0.083|TWO_SIDED|95.0|0.0|13.8|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||13.8|0.0|0.083
71099899|NCT00289900|141708760|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|11.9||||0.005|TWO_SIDED|95.0|5.2|18.8|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||18.8|5.2|0.005
70995596|NCT04547998|141499864|SUPERIORITY|The difference in the proportion of responders (RECELL-Control) was tested for superiority of RECELL treatment (with a 10% superiority margin). For the null hypothesis to be rejected and super-superiority of RECELL to Control to be established, the lower limit of the 2-sided 95% CI of the difference in the proportion of responders (RECELL-Control) had to be greater than 10%.||||||0.012|||||||continuity-corrected method|Liu et al 2002||||||0.012
71099900|NCT00289900|141708760|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|16.4|||<|0.001|TWO_SIDED|95.0|9.8|22.8|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||22.8|9.8|<0.001
71099901|NCT00289900|141708761|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-12.8|||<|0.001|TWO_SIDED|95.0|-15.6|-9.9|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-9.9|-15.6|<0.001
71099902|NCT00289900|141708761|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.8|||<|0.001|TWO_SIDED|95.0|-13.2|-8.4|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-8.4|-13.2|<0.001
71040618|NCT00500318|141589696|SUPERIORITY_OR_OTHER||Least Square Mean|116.44|STANDARD_ERROR_OF_MEAN|40.113||0.0042|TWO_SIDED|95.0|37.28|195.61|||ANCOVA|||||195.610|37.280|0.0042
71040619|NCT03223909|141589849|NON_INFERIORITY|"it was considered as not inferior when the treatments did not present differences greater than 20%~Statistical analysis of groups in the baseline visit versus final visit"||||||0.08|||||||ANOVA|||||||0.080
71040620|NCT03223909|141589849|NON_INFERIORITY|"it was considered as not inferior when the treatments did not present differences greater than 20%~Statistical analysis between groups in the final visit"||||||0.848|||||||ANOVA|||||||0.848
71040621|NCT03223909|141589850|NON_INFERIORITY|it was considered as not inferior when the treatments did not present differences greater than 20%||||||0.468|||||||Chi-squared, Corrected|||||||0.468
71040622|NCT03223909|141589851|NON_INFERIORITY|population analysis was per protocol||||||0.0001|||||||ANOVA|||||||0.0001
71040623|NCT03223909|141589851|NON_INFERIORITY|population analysis was per protocol||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.650
71040624|NCT03223909|141589852|NON_INFERIORITY|"It was considered as not inferior when the treatments did not present differences greater than 20%~Statistical analysis of Humylub® Ofteno (PRO-087) versus Systane® Ultra PF at the final visit."||||||0.003|||||||ANOVA|||||||0.003
71040625|NCT03223909|141589852|NON_INFERIORITY|It was considered as not inferior when the treatments did not present differences greater than 20% Statistical analysis of Humylub® Ofteno (PRO-087) versus Systane® Ultra PF at the final visit.||||||0.003|||||||ANOVA|||||||0.003
71040626|NCT03223909|141589853|NON_INFERIORITY|"the statistical analysis was carried out by intention to treat~It was considered as not inferior when the treatments did not present differences greater than 20%"||||||0.93|||||||Chi-squared|||||||0.930
71040627|NCT03223909|141589854|NON_INFERIORITY|it was considered as not inferior when the treatments did not present differences greater than 20%||||||0.548|||||||ANOVA|||||||0.548
71040628|NCT03223909|141589855|NON_INFERIORITY|it was considered as not inferior when the treatments did not present differences greater than 20%||||||0.17|||||||ANOVA|||||||0.170
71040629|NCT03223909|141589856|NON_INFERIORITY|it was considered as not inferior when the treatments did not present differences greater than 20%||||||0.085|||||||Chi-squared, Corrected|||||||0.085
71040630|NCT01628549|141589859|SUPERIORITY||Difference in Least Squares Means|1.53||||0.4344|TWO_SIDED|95.0|-2.32|5.38|||ANCOVA|||||5.38|-2.32|0.4344
71040631|NCT01628549|141589859|SUPERIORITY||Difference in Least Squares Means|4.46||||0.0266|TWO_SIDED|95.0|0.52|8.4|||ANCOVA|||||8.40|0.52|0.0266
71040632|NCT01628549|141589859|SUPERIORITY||Difference in Least Squares Means|4.37||||0.0317|TWO_SIDED|95.0|0.39|8.36|||ANCOVA|||||8.36|0.39|0.0317
71040633|NCT01628549|141589860|SUPERIORITY||Difference vs placebo in success rate|3.4||||0.33|TWO_SIDED|95.0|-7.82|14.38|||Cochran-Mantel-Haenszel|||||14.38|-7.82|0.3300
71040634|NCT01628549|141589860|SUPERIORITY||Difference vs placebo in success rate|13.2||||0.0159|TWO_SIDED|95.0|0.54|25.6|||Cochran-Mantel-Haenszel|||||25.60|0.54|0.0159
71040635|NCT01628549|141589860|SUPERIORITY||Difference vs placebo in success rate|4.1||||0.4834|TWO_SIDED|95.0|-7.44|15.87|||Cochran-Mantel-Haenszel|||||15.87|-7.44|0.4834
71040636|NCT01332968|141589910|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.66||||0.0012|TWO_SIDED|95.0|0.51|0.85|||Log Rank|Stratified by chemotherapy regimen and Follicular Lymphoma International Prognostic Index (FLIPI) risk group.||||0.85|0.51|0.0012
71099903|NCT00289900|141708761|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-6.4||||0.001|TWO_SIDED|95.0|-8.8|-4.0|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-4.0|-8.8|0.001
71040637|NCT01332968|141589911|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.0055|TWO_SIDED|95.0|0.64|0.93|||Log Rank|Stratified by chemotherapy regimen and Follicular Lymphoma International Prognostic Index (FLIPI) risk group.||||0.93|0.64|0.0055
71040638|NCT01332968|141589912|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0028|TWO_SIDED|95.0|0.65|0.91|||Log Rank|||||0.91|0.65|0.0028
71040639|NCT01332968|141589913|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0118|TWO_SIDED|95.0|0.56|0.93|||Log Rank|||||0.93|0.56|0.0118
71040640|NCT01332968|141589914|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0038||95.0|0.57|0.9|||Log Rank|||||0.90|0.57|0.0038
71040641|NCT01332968|141589915|SUPERIORITY||Absolute difference in %|1.8||||0.3|TWO_SIDED|95.0|-2.02|5.68|||Log Rank|||Without PET||5.68|-2.02|0.30
71040642|NCT01332968|141589915|SUPERIORITY||Absolute difference in %|4.3||||0.17|TWO_SIDED|95.0|-1.8|10.5|||Log Rank|||With PET||10.5|-1.8|0.17
71040643|NCT01332968|141589916|SUPERIORITY||Absolute difference in %|1.6||||0.33|TWO_SIDED|95.0|-2.0|5.3|||Log Rank|||Without PET||5.3|-2.0|0.33
71040644|NCT01332968|141589916|SUPERIORITY||Absolute difference in %|3.5||||0.17|TWO_SIDED|95.0|-2.3|9.4|||Log Rank|||With PET||9.4|-2.3|0.17
71040645|NCT01332968|141589917|SUPERIORITY||Absolute difference in %|-5.5||||0.02|TWO_SIDED|95.0|-10.2|-0.78|||Log Rank|||Without PET||-0.78|-10.2|0.02
71040646|NCT01332968|141589917|SUPERIORITY||Absolute difference in %|5.2||||0.32|TWO_SIDED|95.0|-2.8|13.3|||Log Rank|||With PET||13.3|-2.8|0.32
71040647|NCT01332968|141589918|SUPERIORITY||Absolute difference in %|-4.9||||0.02||95.0|-9.3|0.6|||Log Rank|||Without PET||0.6|-9.3|0.02
71040648|NCT01332968|141589918|SUPERIORITY||Absolute difference in %|4.1||||0.33||95.0|-3.6|11.8|||Log Rank|||With PET||11.8|-3.6|0.33
71040649|NCT01332968|141589919|SUPERIORITY||Absolute difference in %|3.3||||0.052|TWO_SIDED|95.0|-0.19|6.85|||Log Rank|||Without PET||6.85|-0.19|0.052
71040650|NCT01332968|141589919|SUPERIORITY||Absolute difference in %|3.3||||0.3|TWO_SIDED|95.0|-2.3|8.9|||Log Rank|||With PET||8.9|-2.3|0.30
71040651|NCT01332968|141589920|SUPERIORITY||Absolute difference in %|3.2||||0.049|TWO_SIDED|95.0|-0.3|6.6|||Log Rank|||Without PET||6.6|-0.3|0.049
71040652|NCT01332968|141589920|SUPERIORITY||Absolute difference in %|3.9||||0.22|TWO_SIDED|95.0|-1.7|9.5|||Log Rank|||With PET||9.5|-1.7|0.22
71040653|NCT01332968|141589921|SUPERIORITY||Absolute difference in %|1.7||||0.58|TWO_SIDED|95.0|-3.5|6.8|||Log Rank|||Without PET||6.8|-3.5|0.58
71099904|NCT00289900|141708761|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.6|||<|0.001|TWO_SIDED|95.0|-8.0|-3.2|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-3.2|-8.0|<0.001
71099905|NCT00289900|141708762|SUPERIORITY_OR_OTHER||Difference in Proportion|-1.4||||0.008|TWO_SIDED|95.0|-2.3|-0.5|||Miettinen and Nurminen|||||-0.5|-2.3|0.008
70923566|NCT06311084|141338746|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
70923567|NCT06311084|141338747|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
70923568|NCT05249439|141338754|OTHER|Paired t-test|Mean Difference (Final Values)|-12.99|||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||I-SatPro starting weight Vs 52 week weight (kg)||||<0.0001
70923569|NCT03526861|141338770|SUPERIORITY|Primary endpoint tested sequentially at a 5% significance level|Risk Difference (RD)|13.8||||0.002|TWO_SIDED|95.0|5.3|22.3||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Subjects with IGA score of 0 (clear) or 1 (almost clear) at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||22.3|5.3|0.002
70923570|NCT03526861|141338770|SUPERIORITY|Primary endpoint tested sequentially at a 5% significance level|Risk Difference (RD)|17.5|||<|0.001|TWO_SIDED|95.0|8.4|26.6||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Subjects with IGA score of 0 (clear) or 1 (almost clear) at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||26.6|8.4|<0.001
70923571|NCT03526861|141338771|SUPERIORITY|Primary endpoint tested sequentially at a 5% significance level|Risk Difference (RD)|22.0|||<|0.001|TWO_SIDED|95.0|12.0|32.0||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Subjects who achieved at least 75% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||32.0|12.0|<0.001
70923572|NCT03526861|141338771|SUPERIORITY|Primary endpoint tested sequentially at a 5% significance level|Risk Difference (RD)|22.5|||<|0.001|TWO_SIDED|95.0|12.4|32.6||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Subjects who achieved at least 75% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||32.6|12.4|<0.001
70995597|NCT04547998|141499865|SUPERIORITY||||||<|0.001||||||P-value based on Wilcoxon signed rank test at 2-sided 0.05 significance level. The Wilcoxon signed rank test was based on the following repigmentation categories: 0% to 25%, 26% to 50%, 51% to 79%, and 80% to 100%.|Wilcoxon (Mann-Whitney)|||||||<0.001
70995598|NCT04547998|141499866|SUPERIORITY|||||||1||||||2-sided (0.05 significance level), based on 19 participants with assessable color matching outcomes for both treatments|Wilcoxon (Mann-Whitney)|||||||1.000
70995599|NCT00881361|141499882|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
70995600|NCT02988219|141499888|SUPERIORITY_OR_OTHER|||||||0.3861|||||||Chi-squared|||Bradycardia during surgery||||0.3861
70995601|NCT02988219|141499888|SUPERIORITY_OR_OTHER|||||||0.2591|||||||Chi-squared|||No bradycardia observed in the perioperative period||||0.2591
70995602|NCT02988219|141499889|SUPERIORITY_OR_OTHER|||||||0.597|||||||Chi-squared|||Arrhythmia before surgery||||0.597
70995603|NCT02988219|141499889|SUPERIORITY_OR_OTHER|||||||0.4|||||||Chi-squared|||arrhythmia during surgery||||0.4
70995604|NCT02988219|141499889|SUPERIORITY_OR_OTHER|||||||0.6544|||||||Chi-squared|||arrhythmia after surgery||||0.6544
70995605|NCT02988219|141499889|SUPERIORITY_OR_OTHER|||||||0.077|||||||Chi-squared|||long QTc \> 0.45s after surgery||||0.077
70995606|NCT02988219|141499889|SUPERIORITY_OR_OTHER|||||||0.0174|||||||Chi-squared|||long QTc \> 0.24 s in the perioperative time||||0.0174
70995607|NCT01522443|141499890|SUPERIORITY_OR_OTHER|||||||0.773|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel (CMH) was stratified by the Eastern Cooperative Oncology Group performance status and prior cabazitaxel use.||||||0.773
70995608|NCT01522443|141499891|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel (CMH) Test was stratified by baslined Eastern Cooperative Oncology Group performance status and prior cabazitaxel use.||||||<0.001
70995609|NCT01522443|141499892|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.121|TWO_SIDED|95.0|0.44|1.1|||Log Rank|The Log-Rank Test was stratified by baseline Eastern Cooperative Oncology Group performance status and prior cabazitaxel use.||||1.10|0.44|0.121
70995610|NCT02940626|141499941|OTHER|||||||0.547|||||||Wald Test on equality of proportions|||Subjects were analyzed for efficacy in the group to which they randomized. Sponsor defined outcomes were based on review of microbiology results from samples tested at the central lab. If sample was not sent to the central lab., determination was based on results from the local microbiology lab. In cases where both local \& central lab results were available, concordance was confirmed for S. aureus. Therefore, the analysis used local microbiology data in order to utilize a more complete dataset.||||.5470
70995611|NCT05127421|141499969|SUPERIORITY||Odds Ratio (OR)|2.81||||0.091|TWO_SIDED|95.0|0.83|9.47|||Cochran-Mantel-Haenszel|stratified by the stratification factor (face and/or neck Investigator's Global Assessment \[IGA\] score of 2 or 3 at screening).||||9.47|0.83|0.091
70995612|NCT05127421|141499969|SUPERIORITY||response rate difference|19.5|STANDARD_ERROR_OF_MEAN|10.23|||TWO_SIDED|95.0|-0.5|39.6|||||The 95% confidence interval was computed based on a large-sample normal approximation with continuity correction.|||39.6|-0.5|
70995613|NCT00138424|141499997|SUPERIORITY_OR_OTHER||Spearman Correlation|0.24||||0.57|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK Cmax parameter||||0.57
70995614|NCT00138424|141499997|SUPERIORITY_OR_OTHER||Spearman Correlation|0.26||||0.53|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK Cmax parameter||||0.53
70995615|NCT00138424|141499997|SUPERIORITY_OR_OTHER||Spearman Correlation|-0.3||||0.62|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK Cmax parameter||||0.62
70995616|NCT00138424|141499997|SUPERIORITY_OR_OTHER||Spearman Correlation|0.8||||0.1|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK Cmax parameter||||0.10
70995617|NCT00138424|141499998|SUPERIORITY_OR_OTHER||Spearman Correlation|0.07||||0.87|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK AUC4 parameter||||0.87
70995618|NCT00138424|141499998|SUPERIORITY_OR_OTHER||Spearman Correlation|0.31||||0.46|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK AUC4 parameter||||0.46
70995619|NCT00138424|141499998|SUPERIORITY_OR_OTHER||Spearman Correlation|-0.41||||0.49|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK AUC4 parameter||||0.49
70995620|NCT00138424|141499998|SUPERIORITY_OR_OTHER||Spearman Correlation|0.87||||0.05|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK AUC4 parameter||||0.05
70995621|NCT00138424|141499998|SUPERIORITY_OR_OTHER||Spearman Correlation|0.12||||0.78|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK AUC12 parameter||||0.78
70995622|NCT00138424|141499998|SUPERIORITY_OR_OTHER||Spearman Correlation|0.52||||0.18|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK AUC12 parameter||||0.18
70995623|NCT00138424|141499998|SUPERIORITY_OR_OTHER||Spearman Correlation|0.2||||0.75|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK AUC12 parameter||||0.75
70995624|NCT00138424|141499998|SUPERIORITY_OR_OTHER||Spearman Correlation|0.2||||0.75|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK AUC12 parameter||||0.75
70995625|NCT01802554|141499999|SUPERIORITY_OR_OTHER|||||||0.039|||||||Mixed Models Analysis|||||||.039
70995626|NCT01802554|141500000|SUPERIORITY_OR_OTHER|||||||0.701|||||||Mixed Models Analysis|||||||.701
70995627|NCT01802554|141500001|SUPERIORITY_OR_OTHER|||||||0.04|||||||Mixed Models Analysis|||||||.04
70995628|NCT01802554|141500002|SUPERIORITY_OR_OTHER|||||||0.268|||||||Mixed Models Analysis|||||||.268
70995629|NCT01802554|141500003|SUPERIORITY_OR_OTHER|||||||0.021|||||||Mixed Models Analysis|||||||.021
70995630|NCT01167582|141500009|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Day 1 Post Randomization||||<0.001
70995631|NCT01167582|141500009|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Day 2 Post Randomization||||<0.001
70995632|NCT01167582|141500009|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Day 3 Post Randomization||||<0.001
70995633|NCT01167582|141500010|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70995634|NCT01167582|141500011|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.38|||||TWO_SIDED|95.0|0.99|5.73|||||Restrictive Arm (numerator) compared to Liberal Arm (denominator)|||5.73|0.99|
70995635|NCT01167582|141500012|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.7||||||95.0|-5.3|24.7|||||Restrictive Arm (numerator) compared to Liberal Arm (denominator)|||24.7|-5.3|
70995636|NCT01167582|141500013|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|7.13|||||TWO_SIDED|95.0|0.91|56.02|||||Restrictive Arm (numerator) compared to Liberal Arm (denominator)|Mortality||56.02|0.91|
70995637|NCT01167582|141500013|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.43|||||TWO_SIDED|95.0|0.48|4.22|||||Restrictive Arm (numerator) compared to Liberal Arm (denominator)|Myocardial Infarction||4.22|0.48|
70995638|NCT00094887|141500043|OTHER||||||=|0.8085|||||||Wilcoxon (Mann-Whitney)|||||||= 0.8085
70995639|NCT01401465|141500062|SUPERIORITY_OR_OTHER||Slope|88.235|||<|0.0001||||||The significance level was set at 0.025 to adjust for the fact that two co-primary endpoints were being tested.|Two-sided Signed Rank Test||Hodges-Lehman estimate of the CI not available due to ties.|The null hypothesis is that the median of the standardized Total Preference Score = 50. Values \> 50 indicate preference for ciclesonide, while values \< 50 indicate preference for mometasone. For the primary endpoint of the Total Preference Score, assuming an SD of 40, a sample size of 155 will have 80% power to detect a difference of 0.25 SD units (10 raw score units) from the neutrality preference population value of 50, using a single group t-test with a 0.025 two-sided significance level.||||<0.0001
70995640|NCT01401465|141500063|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.9|||<|0.0001|TWO_SIDED|95.0|11.22|16.58||The significance level was set at 0.025 to adjust for the fact that two co-primary endpoints were being tested.|Linear Mixed Model|Linear Mixed Model with effects for Period, Treatment, Sex, Race, Study Center, and covariates of Age and Baseline.||The null hypothesis is that the mean change from baseline (CfBL) for CIC is equal to the mean CfBL for MOM. In Study 060-301, a correlation between BL periods 1 and 2 of 0.7 and a change score SD of 15 was seen for the RACS. A sample size of 41 in each sequence group (82 total ) gives a 2 x 2 crossover design 80% power to detect the difference in the CfBL of 0.35 SD units (5.25 raw score units) using a two group t-test with a 0.025 two-sided significance level and a SD of 15 for the difference.||16.58|11.22|<0.0001
71040654|NCT01332968|141589921|SUPERIORITY||Absolute difference in %|11.7||||0.006|TWO_SIDED|95.0|3.9|19.4|||Log Rank|||||19.4|3.9|0.006
71040655|NCT01332968|141589922|SUPERIORITY||Absolute difference in %|0.7||||0.8|TWO_SIDED|95.0|-4.0|5.5|||Log Rank|||Without PET||5.5|-4.0|0.80
71040656|NCT01332968|141589922|SUPERIORITY||Absolute difference in %|10.1||||0.009||95.0|2.6|17.6|||Log Rank|||With PET||17.6|2.6|0.009
71040657|NCT01332968|141589923|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.3577||95.0|0.63|1.18|||Log Rank|||||1.18|0.63|0.3577
71040658|NCT01332968|141589924|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.25||95.0|0.58|1.16|||Log Rank|||||1.16|0.58|0.25
70923573|NCT03526861|141338772|SUPERIORITY|Secondary endpoint tested sequentially at a 2.5% significance level|Risk Difference (RD)|21.7|||<|0.001|TWO_SIDED|95.0|12.3|31.1||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Subjects with at least 4-point reduction in Adolescent Worst Pruritus NRS were considered responders. Subjects with missing data or who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||31.1|12.3|<0.001
70923574|NCT03526861|141338772|SUPERIORITY|Secondary endpoint tested sequentially at a 5% significance level|Risk Difference (RD)|19.9|||<|0.001|TWO_SIDED|95.0|10.6|29.2||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Subjects with at least 4-point reduction in Adolescent Worst Pruritus NRS were considered responders. Subjects with missing data or who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||29.2|10.6|<0.001
70923575|NCT03526861|141338773|SUPERIORITY|This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 2.5% significance level after the sequential testing of the primary endpoints and first secondary endpoint, if these showed statistical significance.|Difference of least square means|-19.7|||<|0.001|TWO_SIDED|95.0|-27.1|-12.2||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-12.2|-27.1|<0.001
71040659|NCT01332968|141589925|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0015|TWO_SIDED|95.0|0.62|0.89|||Log Rank|||||0.89|0.62|0.0015
71040660|NCT01332968|141589926|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0004||95.0|0.56|0.85|||Log Rank|||||0.85|0.56|0.0004
71040661|NCT01332968|141589927|SUPERIORITY||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.71|1.27|||Log Rank|||||1.27|0.71|
71040662|NCT01332968|141589928|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.5|1.19||||||||1.19|0.50|
71040663|NCT01332968|141589929|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.63|0.93|||Log Rank|||||0.93|0.63|
70995641|NCT01401465|141500063|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.88|||<|0.0001|TWO_SIDED|95.0|2.2|7.56||The significance level was set at 0.025 to adjust for the fact that two co-primary endpoints were being tested.|Linear Mixed Model|Linear Mixed Model with effects for Period, Treatment, Sex, Race, Study Center, and covariates of Age and Baseline||The null hypothesis is that the mean change from baseline (CfBL) for CIC is equal to the mean CfBL for MOM. In Study 060-301, a correlation between BL periods 1 and 2 of 0.7 and a change score SD of 15 was seen for the RACS. A sample size of 41 in each sequence group (82 total ) gives a 2 x 2 crossover design 80% power to detect the difference in the CfBL of 0.35 SD units (5.25 raw score units) using a two group t-test with a 0.025 two-sided significance level and a SD of 15 for the difference.||7.56|2.20|<0.0001
71040664|NCT01332968|141589930|SUPERIORITY||Hazard Ratio (HR)|0.69||||||95.0|0.55|0.88||||||||0.88|0.55|
71040665|NCT01332968|141589931|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.001|TWO_SIDED|95.0|0.58|0.87|||Log Rank|||||0.87|0.58|0.001
71040666|NCT01332968|141589932|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.004||95.0|0.54|0.89|||Log Rank|||||0.89|0.54|0.004
71040667|NCT01653405|141589944|SUPERIORITY||||||<|0.001|||||||Difference in differences|||||||<0.001
71040668|NCT01653405|141589945|SUPERIORITY|||||||0.43|||||||test of differences|||||||0.43
71040669|NCT01653405|141589946|SUPERIORITY||||||<|0.001|||||||difference in differences|||||||<0.001
71040670|NCT01653405|141589947|SUPERIORITY||||||<|0.001|||||||Difference in differences|||||||<0.001
71040671|NCT01653405|141589948|SUPERIORITY|||||||0.002|||||||difference in differences|||||||0.002
71040672|NCT01742208|141589955|SUPERIORITY||LS Mean Difference|-25.14||||0.007|TWO_SIDED|95.0|-42.78|-7.49||Threshold for significance at 0.05 level.|ANCOVA||Difference is sotagliflozin - placebo|Between-group comparison of the 2 Expansion Groups was based on an ANCOVA model with covariates of baseline mean total daily bolus insulin, treatment group, factor used to stratify the randomization (screening A1C \<= 8%, \> 8%), and random effect of participant\*treatment group.||-7.49|-42.78|0.007
71040673|NCT00715676|141589962|SUPERIORITY_OR_OTHER|||||||0.641||||||The Hochberg method was used to compare dose groups to placebo and control the Type 1 error rate.|ANOVA|||A sample size of 49 per treatment group was calculated to have at least 90% power to detect a 2% or greater increase over placebo assuming the following: (1) a standard deviation of the percent change of 2.75% (2) a dropout rate of 30%, and (3) one-sided 0.05 level of significance||||0.641
71040674|NCT00715676|141589962|SUPERIORITY_OR_OTHER|||||||0.243||95.0||||The Hochberg method was used to compare dose groups to placebo and control the Type 1 error rate.|ANOVA|||A sample size of 49 per treatment group was calculated to have at least 90% power to detect a 2% or greater increase over placebo assuming the following: (1) a standard deviation of the percent change of 2.75% (2) a dropout rate of 30%, and (3) one-sided 0.05 level of significance||||0.243
71040675|NCT00715676|141589963|SUPERIORITY_OR_OTHER|||||||0.778||95.0|||||ANOVA|||||||0.778
71040676|NCT00715676|141589963|SUPERIORITY_OR_OTHER|||||||0.173||95.0|||||ANOVA|||||||0.173
71040677|NCT00715676|141589964|SUPERIORITY_OR_OTHER|||||||0.395||95.0|||||ANOVA|||||||0.395
71040678|NCT00715676|141589964|SUPERIORITY_OR_OTHER|||||||0.523||95.0|||||ANOVA|||||||0.523
71040679|NCT00715676|141589965|SUPERIORITY_OR_OTHER|||||||0.928||95.0|||||ANOVA|||||||0.928
71040680|NCT00715676|141589965|SUPERIORITY_OR_OTHER|||||||0.124||95.0|||||ANOVA|||||||0.124
71040681|NCT00715676|141589966|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.173||||||90.0|0.164|0.181||||||||0.181|0.164|
71040682|NCT00715676|141589966|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.582||||||90.0|0.573|0.591||||||||0.591|0.573|
71040683|NCT00372996|141589969|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.912||||0.56|TWO_SIDED|80.0|0.744|1.118|||Log Rank|2-sided p-value from an unstratified log-rank text|Hazard ratio was based on Cox proportional hazards model.|||1.118|0.744|0.560
71040684|NCT00372996|141589970|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.764||||0.331|TWO_SIDED|70.0|0.572|1.02||2-sided p-value from unstratified log-rank test|Log Rank||Hazard ratio was based on the Cox proportional hazards model.|||1.020|0.572|0.331
71040685|NCT00372996|141589971|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.79||||0.463|TWO_SIDED|95.0|-8.0|17.6|||Pearson chi-square test|||||17.6|-8.0|0.463
71040686|NCT01091363|141589980|SUPERIORITY||Odds Ratio (OR)|4.67|||<|0.01|TWO_SIDED|95.0|1.67|12.99|||Regression, Logistic|||||12.99|1.67|<0.01
71040687|NCT01091363|141589981|SUPERIORITY_OR_OTHER|Hayes' PROCESS computation tool for a serial multiple mediator model predicting a binary logistic outcome.|Mean Difference (Net)|1.92||||0.02|TWO_SIDED|95.0|0.34|6.32|||Mediation Analysis|||Mediation analyses were performed to examine the effect of the intervention on abstinence via the three theoretic variables (attitudes, perceived family norms, and self-efficacy), using the Hayes' PROCESS computation tool for a serial multiple mediator model with a binary outcome variable (quitting vs. smoking).||6.32|0.34|0.02
71040688|NCT02760433|141589986|SUPERIORITY||Risk Difference (RD)|0.19||||0.004|TWO_SIDED|97.5|0.03|0.337|||Chi-squared|2x2 chi-square test||The ACR20 response rate at Week 12 for the placebo group is estimated to be 20% in this study population. The OKZ ACR20 response rate for 64 mg q4w treatment group at Week 12 are expected to be at least 45%, resulting in an expected difference in ACR20 response rates of 25 percentage points between the respective OKZ treatment group and placebo. Sample size yield 100% disjunctive power for testing the primary hypothesis||0.337|0.030|0.004
71040689|NCT02760433|141589986|SUPERIORITY||Risk Difference (RD)|0.203||||0.0029|TWO_SIDED|97.5|0.038|0.353|||Chi-squared|2x2 chi-square test||The ACR20 response rate at Week 12 for the placebo group is estimated to be 20% in this study population .The OKZ ACR20 response rate for 64 mg q2w treatment group at Week 12 is expected to be at least 50%, resulting in an expected difference in ACR20 response rates of 30 percentage points between the respective OKZ treatment group and placebo. Sample size yield 100% disjunctive power for testing the primary hypothesis||0.353|0.038|0.0029
71040690|NCT02760433|141589987|SUPERIORITY||Risk Difference (RD)|0.176||||0.0021|TWO_SIDED|97.5|0.041|0.281|||Chi-squared|2x2 chi-square test||The DAS28 low disease activity (based on DAS28 \[CRP\] \<3.2) response rate at Week 12 was estimated to be 5% in the placebo group and 18% and 21% in 64 mg q4w and q2w OKZ groups, respectively, resulting in an expected difference of 13 and 16 percentage points between respective OKZ groups and placebo.||0.281|0.041|0.0021
70923576|NCT03526861|141338773|SUPERIORITY|This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 5% significance level after the sequential testing of the primary endpoints and first secondary endpoint, if these showed statistical significance.|Difference of least square means|-18.0|||<|0.001|TWO_SIDED|95.0|-25.6|-10.4||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-10.4|-25.6|<0.001
71099906|NCT00289900|141708763|SUPERIORITY_OR_OTHER||Difference in Proportion|-0.7||||0.042|TWO_SIDED|95.0|-1.4|0.0|||Miettinen and Nurminen|||||-0.0|-1.4|0.042
71099907|NCT00289900|141708764|SUPERIORITY_OR_OTHER||Difference in Proportion|-0.1||||0.346|TWO_SIDED|95.0|-0.5|0.4|||Miettinen and Nurminen|||||0.4|-0.5|0.346
71099908|NCT00289900|141708765|SUPERIORITY_OR_OTHER||Difference in Proportion|0.1||||0.556|TWO_SIDED|95.0|-0.2|0.7|||Miettinen and Nurminen|||||0.7|-0.2|0.556
71099909|NCT00289900|141708766|SUPERIORITY_OR_OTHER||Difference in Proportion|0.1||||0.134|TWO_SIDED|95.0|-0.1|0.8|||Miettinen and Nurminen|||||0.8|-0.1|0.134
71099910|NCT00289900|141708767|SUPERIORITY_OR_OTHER||Difference in Proportion|0.1||||0.134||95.0|-0.1|0.8|||Miettinen and Nurminen|||||0.8|-0.1|0.134
71099911|NCT00289900|141708768|SUPERIORITY_OR_OTHER||Difference in Percentage|0.1||||0.5625|TWO_SIDED|95.0|-0.3|0.9|||Miettinen and Nurminen|||||0.9|-0.3|0.5625
71099912|NCT00289900|141708769|SUPERIORITY_OR_OTHER||Difference in Percentage|0.7||||0.0233|TWO_SIDED|95.0|0.1|1.7|||Miettinen and Nurminen|||||1.7|0.1|0.0233
71099913|NCT00289900|141708770|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.1||||0.7858|TWO_SIDED|95.0|-0.4|0.6|||Miettinen and Nurminen|||||0.6|-0.4|0.7858
71099914|NCT00289900|141708771|SUPERIORITY_OR_OTHER||Difference in Percentage|13.7|||||TWO_SIDED|95.0|9.4|18.0|||Miettinen and Nurminen|||||18.0|9.4|
71099915|NCT00289900|141708772|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.7|||||TWO_SIDED|95.0|-2.6|1.4|||Miettinen and Nurminen|||||1.4|-2.6|
71099916|NCT00289900|141708773|SUPERIORITY_OR_OTHER||Difference in Percentage|11.7|||||TWO_SIDED|95.0|8.9|14.7|||Miettinen and Nurminen|||||14.7|8.9|
71099917|NCT00289900|141708774|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.1|||||TWO_SIDED|95.0|-0.8|0.9|||Miettinen and Nurminen|||||0.9|-0.8|
71099918|NCT00289900|141708775|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.1||||0.4997|TWO_SIDED|95.0|-0.4|0.5|||Miettinen and Nurminen|||||0.5|-0.4|0.4997
71099919|NCT02656173|141708784|SUPERIORITY||least square mean difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.82|-0.21|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis, including treatment group and region as fixed factors and baseline as a covariate.||-0.21|-0.82|<0.001
71099920|NCT02656173|141708785|SUPERIORITY||least square mean difference|-0.48|||<|0.001|TWO_SIDED|95.0|-0.78|-0.17|||mixed model repeated measure|||Mixed Model Repeated Measure (MMRM) was used for analysis, which included the baseline as a covariate, treatment group, analysis visits and region as a fixed effect, subject as random effect and including interaction of \[treatment group x visit\] for FAS.||-0.17|-0.78|<0.001
71099921|NCT02656173|141708786|SUPERIORITY||least square mean difference|-0.28||||0.112|TWO_SIDED|95.0|-0.63|0.07|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||0.07|-0.63|0.112
71099922|NCT02656173|141708787|SUPERIORITY||Cochran-Mantel-Haenszel Statistics|1.75||||0.186|||||||Stratified Rank Analysis of Covariance|||Stratified Rank Analysis of Covariance (RANCOVA), including the rank score for change from Baseline to End of Treatment stratified by region as the dependent variable, treatment group and region as fixed factors and the rank score for baseline stratified by region as a covariate for FAS.||||0.186
71099923|NCT02656173|141708788|SUPERIORITY||Cochran-Mantel-Haenszel Statistics|0.09||||0.76|||||||Stratified Rank Analysis of Covariance|||Stratified Rank Analysis of Covariance (RANCOVA), including the rank score for change from Baseline to End of Treatment stratified by region as the dependent variable, treatment group and region as fixed factors and the rank score for baseline stratified by region as a covariate for FAS.||||0.760
71099924|NCT02656173|141708789|SUPERIORITY||Least square mean difference|-0.03||||0.646|TWO_SIDED|95.0|-0.18|0.11|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||0.11|-0.18|0.646
71099925|NCT02656173|141708790|SUPERIORITY||Least square mean difference|12.08|||<|0.001|TWO_SIDED|95.0|6.33|17.84|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||17.84|6.33|<0.001
71099926|NCT02656173|141708791|SUPERIORITY||Least square mean difference|-0.65||||0.001|TWO_SIDED|95.0|-1.04|-0.26|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.26|-1.04|0.001
71099927|NCT02656173|141708792|SUPERIORITY||Least square mean difference|-0.11||||0.006|TWO_SIDED|95.0|-0.19|-0.03|||ANCOVA|||Subscale: Daytime Frequency. Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.03|-0.19|0.006
71099928|NCT02656173|141708792|SUPERIORITY||Least square mean difference|-0.08||||0.174|TWO_SIDED|95.0|-0.19|0.03|||ANCOVA|||Subscale: Nighttime Frequency. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||0.03|-0.19|0.174
71099929|NCT02656173|141708792|SUPERIORITY||Least square mean difference|-0.26||||0.037|TWO_SIDED|95.0|-0.5|-0.02|||ANCOVA|||Subscale: Urgency. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.02|-0.50|0.037
71099930|NCT02656173|141708792|SUPERIORITY||Least square mean difference|-0.18||||0.014|TWO_SIDED|95.0|-0.32|-0.04|||ANCOVA|||Subscale: Urgency Incontinence. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.04|-0.32|0.014
71099931|NCT02656173|141708793|SUPERIORITY||Least square mean difference|-1.19||||0.002|TWO_SIDED|95.0|-1.94|-0.44|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.44|-1.94|0.002
71099932|NCT02656173|141708794|SUPERIORITY||Least square mean difference|-0.78|||<|0.001|TWO_SIDED|95.0|-1.13|-0.43|||ANCOVA|||Subscale: Storage Subscale. Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.43|-1.13|<0.001
71099933|NCT02656173|141708794|SUPERIORITY||Least square mean difference|-0.3||||0.167|TWO_SIDED|95.0|-0.72|0.13|||ANCOVA|||Subscale: Voiding Subscale-1. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||0.13|-0.72|0.167
70923577|NCT03526861|141338774|SUPERIORITY|This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 2.5% significance level after the sequential testing of the primary endpoints and first secondary endpoint, if these showed statistical significance.|Difference of least square means|-2.6||||0.007|TWO_SIDED|95.0|-4.5|-0.7||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-0.7|-4.5|0.007
70923578|NCT03526861|141338774|SUPERIORITY|This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 5% significance level after the sequential testing of the primary endpoints and first secondary endpoint, if these showed statistical significance.|Difference of least square means|-2.0||||0.04|TWO_SIDED|95.0|-3.9|-0.1||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-0.1|-3.9|0.040
71099934|NCT02656173|141708794|SUPERIORITY||Least square mean difference|-0.42||||0.103|TWO_SIDED|95.0|-0.93|0.09|||ANCOVA|||Subscale: Voiding Subscale-2. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||0.09|-0.93|0.103
71099935|NCT02656173|141708794|SUPERIORITY||Least square mean difference|-0.29||||0.009|TWO_SIDED|95.0|-0.51|-0.07|||ANCOVA|||Subscale: Quality of Life (QoL) Item. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.07|-0.51|0.009
71099936|NCT02656173|141708795|SUPERIORITY||Least square mean difference|-4.52|||<|0.001|TWO_SIDED|95.0|-6.91|-2.13|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-2.13|-6.91|<0.001
71099937|NCT02656173|141708796|SUPERIORITY||Least square mean difference|2.79|||<|0.001|TWO_SIDED|95.0|1.13|4.44|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||4.44|1.13|<0.001
71099938|NCT01064622|141708800|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.15|TWO_SIDED|95.0|0.55|1.22||Reported p-value is one-sided. p\<0.10 required for statistical significance.|Log Rank|Stratified by Karnofsky performance status (90-100 vs. 80) and disease status (newly diagnosed vs. recurrent after surgery)|Hazard ratio is for (gemcitabine hydrochloride plus vismodegib)/(gemcitabine hydrochloride plus placebo), adjusted for Karnofsky performance status (90-100 vs. 80) and disease status (newly diagnosed vs. recurrent after surgery)|||1.22|0.55|0.15
71099939|NCT01064622|141708801|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.96||||0.37|TWO_SIDED|95.0|0.64|1.46|||Log Rank|Stratified by Karnofsky performance status (90-100 vs. 80) and disease status (newly diagnosed vs. recurrent after surgery)|Hazard ratio is for (gemcitabine hydrochloride plus vismodegib)/(gemcitabine hydrochloride plus placebo), adjusted for Karnofsky performance status (90-100 vs. 80) and disease status (newly diagnosed vs. recurrent after surgery)|||1.46|0.64|0.37
71099940|NCT01064622|141708802|SUPERIORITY_OR_OTHER_LEGACY|||||||0.42|TWO_SIDED|||||Two-sided p-value for Cochran-Mantel-Haenszel test stratified by Karnofsky performance status and disease status.|Cochran-Mantel-Haenszel|||||||0.42
71099941|NCT02037984|141708856|OTHER|PT1 GMC Ratio (V114/Prevnar 13®)|PT1 GMC Ratio|0.81|||||TWO_SIDED|95.0|0.6|1.1||||||||1.10|0.60|
71099942|NCT02037984|141708856|OTHER|PT3 GMC Ratio (V114/Prevnar 13®)|PT3 GMC Ratio|2.22|||||TWO_SIDED|95.0|1.64|3.02||||||||3.02|1.64|
71099943|NCT02037984|141708856|OTHER|PT4 GMC Ratio (V114/Prevnar 13®)|PT4 GMG Ratio|1.37|||||TWO_SIDED|95.0|1.01|1.84||||||||1.84|1.01|
71099944|NCT02037984|141708856|OTHER|PT5 GMC Ratio (V114/Prevnar 13®)|PT5 GMC Ratio|0.71|||||TWO_SIDED|95.0|0.48|1.05||||||||1.05|0.48|
71099945|NCT02037984|141708856|OTHER|PT6A GMC Ratio (V114/Prevnar 13®)|PT6A GMC Ratio|0.6|||||TWO_SIDED|95.0|0.32|1.13||||||||1.13|0.32|
71099946|NCT02037984|141708856|OTHER|PT6B GMC Ratio (V114/Prevnar 13®)|PT6B GMG Ratio|0.34|||||TWO_SIDED|95.0|0.16|0.73||||||||0.73|0.16|
71099947|NCT02037984|141708856|OTHER|PT7F GMC Ratio (V114/Prevnar 13®)|PT7F GMC Ratio|0.72|||||TWO_SIDED|95.0|0.51|1.02||||||||1.02|0.51|
71099948|NCT02037984|141708856|OTHER|PT9V GMC Ratio (V114/Prevnar 13®)|PT9V GMC Ratio|0.74|||||TWO_SIDED|95.0|0.51|1.08||||||||1.08|0.51|
71099949|NCT02037984|141708856|OTHER|PT14 GMC Ratio (V114/Prevnar®)|PT9V GMC Ratio|0.59|||||TWO_SIDED|95.0|0.39|0.9||||||||0.90|0.39|
71099950|NCT02037984|141708856|OTHER|PT18C GMC Ratio (V114/Prevnar 13®)|PT18C GMC Ratio|0.92|||||TWO_SIDED|95.0|0.64|1.31||||||||1.31|0.64|
71099951|NCT02037984|141708856|OTHER|PT19A GMC Ratio (V114/Prevnar 13®)|PT19A GMC Ratio|0.88|||||TWO_SIDED|95.0|0.61|1.27||||||||1.27|0.61|
71099952|NCT02037984|141708856|OTHER|PT19F GMC Ratio (V114/Prevnar 13®)|PT19F GMC Ratio|1.22|||||TWO_SIDED|95.0|0.83|1.78||||||||1.78|0.83|
70995642|NCT01401465|141500064|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|88.889|||<|0.0001||||||If both primary endpoints are significant, the evaluation of this key secondary endpoint will be conducted at a significance level of 0.05.|Two-sided signed-rank test||Hodges-Lehman estimate of the CI not available due to ties.|The null hypothesis is that the median of the standardized Treatment Process Composite Preference Score = 50. Values \> 50 indicate preference for ciclesonide, while values \< 50 indicate preference for mometasone. Assuming an SD of 40, as observed in Study 060-301, a sample size of 128 will have 80% power to detect a difference of 0.25 SD units (10 raw score units) from the neutrality preference population value of 50, using a single group t-test with a 0.05 two-sided significant level||||<0.0001
71099953|NCT02037984|141708856|OTHER|PT23F GMC Ratio (V114/Prevnar 13®)|PT23F GMC Ratio|0.91|||||TWO_SIDED|95.0|0.57|1.45||||||||1.45|0.57|
71099954|NCT02037984|141708856|OTHER|non-PT22F GMC Ratio (V114/Prevnar 13®)|non-PT22F GMC Ratio|67.5|||||TWO_SIDED|95.0|45.58|99.97||||||||99.97|45.58|
70995643|NCT01401465|141500065|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CI of the LS mean difference of ciclesonide nasal aerosol minus mometasone aqueous nasal spray was calculated from the ANCOVA model, and the upper bound of the CI was compared to the non-inferiority margin of 0.5. Non-inferiority was declared if the upper bound of the 95% CI of this difference was \< 0.5.|Difference in LS Means|-0.1|||||TWO_SIDED|95.0|-0.3|0.1||f both primary endpoints are significant, the evaluation of this key secondary endpoint will be conducted at a significance level of 0.05.|ANCOVA|Site, treatment, period, treatment sequence as fixed effects, subject nested within sequence as a random effect, and baseline rTNSS as a covariate.|Ciclesonide 74 mcg minus Mometasone 200 mcg|The null hypothesis is that the change from baseline in rTNSS for ciclesonide 74 mcg nasal aerosol minus the change from baseline in rTNSS for mometasone AQ 200 mcg is greater than 0.5.||0.1|-0.3|
71099955|NCT02037984|141708856|OTHER|non-PT33F GMC Ratio (V114/Prevnar 13®)|non-PT33F GMC Ratio|23.9|||||TWO_SIDED|95.0|13.21|43.24||||||||43.24|13.21|
71099956|NCT02037984|141708857|OTHER|PT1 GMC Ratio (V114/Prevnar 13®)|PT1 GMC Ratio|0.52|||||TWO_SIDED|95.0|0.39|0.7||||||||0.70|0.39|
71099957|NCT02037984|141708857|OTHER|PT3 GMC Ratio (V114/Prevnar 13®)|PT3 GMC Ratio|1.79|||||TWO_SIDED|95.0|1.33|2.41||||||||2.41|1.33|
71099958|NCT02037984|141708857|OTHER|PT4 GMC Ratio (V114/Prevnar 13®)|PT4 GMG Ratio|0.87|||||TWO_SIDED|95.0|0.65|1.16||||||||1.16|0.65|
71099959|NCT02037984|141708857|OTHER|PT5 GMC Ratio (V114/Prevnar 13®)|PT5 GMC Ratio|0.51|||||TWO_SIDED|95.0|0.35|0.74||||||||0.74|0.35|
71099960|NCT02037984|141708857|OTHER|PT6A GMC Ratio (V114/Prevnar 13®)|PT6A GMC Ratio|0.31|||||TWO_SIDED|95.0|0.17|0.58||||||||0.58|0.17|
71099961|NCT02037984|141708857|OTHER|PT6B GMC Ratio (V114/Prevnar 13®)|PT6B GMG Ratio|0.16|||||TWO_SIDED|95.0|0.08|0.34||||||||0.34|0.08|
71099962|NCT02037984|141708857|OTHER|PT7F GMC Ratio (V114/Prevnar 13®)|PT7F GMC Ratio|0.48|||||TWO_SIDED|95.0|0.34|0.67||||||||0.67|0.34|
71099963|NCT02037984|141708857|OTHER|PT9V GMC Ratio (V114/Prevnar 13®)|PT9V GMC Ratio|0.56|||||TWO_SIDED|95.0|0.39|0.82||||||||0.82|0.39|
71099964|NCT02037984|141708857|OTHER|PT14 GMC Ratio (V114/Prevnar®)|PT9V GMC Ratio|0.64|||||TWO_SIDED|95.0|0.42|0.97||||||||0.97|0.42|
71099965|NCT02037984|141708857|OTHER|PT18C GMC Ratio (V114/Prevnar 13®)|PT18C GMC Ratio|0.85|||||TWO_SIDED|95.0|0.6|1.21||||||||1.21|0.60|
71099966|NCT02037984|141708857|OTHER|PT19A GMC Ratio (V114/Prevnar 13®)|PT19A GMC Ratio|0.66|||||TWO_SIDED|95.0|0.46|0.95||||||||0.95|0.46|
71099967|NCT02037984|141708857|OTHER|PT19F GMC Ratio (V114/Prevnar 13®)|PT19F GMC Ratio|1.11|||||TWO_SIDED|95.0|0.77|1.6||||||||1.60|0.77|
71099968|NCT02037984|141708857|OTHER|PT23F GMC Ratio (V114/Prevnar 13®)|PT23F GMC Ratio|0.68|||||TWO_SIDED|95.0|0.43|1.07||||||||1.07|0.43|
71099969|NCT02037984|141708857|OTHER|non-PT22F GMC Ratio (V114/Prevnar 13®)|non-PT22F GMC Ratio|44.61|||||TWO_SIDED|95.0|30.42|65.43||||||||65.43|30.42|
71099970|NCT02037984|141708857|OTHER|non-PT33F GMC Ratio (V114/Prevnar 13®)|non-PT33F GMC Ratio|15.29|||||TWO_SIDED|95.0|8.58|27.26||||||||27.26|8.58|
71099971|NCT02037984|141708858|OTHER|PT1 GMC Ratio (V114/Prevnar 13®)|PT1 GMC Ratio|0.78|||||TWO_SIDED|95.0|0.57|1.07||||||||1.07|0.57|
71099972|NCT02037984|141708858|OTHER|PT3 GMC Ratio (V114/Prevnar 13®)|PT3 GMC Ratio|2.68|||||TWO_SIDED|95.0|1.95|3.68||||||||3.68|1.95|
71099973|NCT02037984|141708858|OTHER|PT4 GMC Ratio (V114/Prevnar 13®)|PT4 GMG Ratio|1.52|||||TWO_SIDED|95.0|1.11|2.07||||||||2.07|1.11|
71099974|NCT02037984|141708858|OTHER|PT5 GMC Ratio (V114/Prevnar 13®)|PT5 GMC Ratio|0.68|||||TWO_SIDED|95.0|0.46|1.02||||||||1.02|0.46|
71099975|NCT02037984|141708858|OTHER|PT6A GMC Ratio (V114/Prevnar 13®)|PT6A GMC Ratio|0.33|||||TWO_SIDED|95.0|0.17|0.64||||||||0.64|0.17|
70923579|NCT03526861|141338777|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|38.5|||<|0.001|TWO_SIDED|95.0|26.8|50.2||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 50% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||50.2|26.8|<0.001
70923580|NCT03526861|141338777|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|32.4|||<|0.001|TWO_SIDED|95.0|20.6|44.1||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 50% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||44.1|20.6|<0.001
70923581|NCT03526861|141338778|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|13.7||||0.002|TWO_SIDED|95.0|5.2|22.2||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 90% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||22.2|5.2|0.002
70923582|NCT03526861|141338778|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|15.3|||<|0.001|TWO_SIDED|95.0|6.5|24.1||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 90% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||24.1|6.5|<0.001
70923583|NCT03526861|141338779|SUPERIORITY|The statistical test was not controlled for multiplicity.|Difference of least square means|-9.4|||<|0.001|TWO_SIDED|95.0|-13.5|-5.3||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-5.3|-13.5|<0.001
70923584|NCT03526861|141338779|SUPERIORITY|The statistical test was not controlled for multiplicity.|Difference of least square means|-9.4|||<|0.001|TWO_SIDED|95.0|-13.6|-5.3||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-5.3|-13.6|<0.001
70923585|NCT03526861|141338780|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|11.5||||0.002|TWO_SIDED|95.0|4.5|18.4||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 75% reduction in SCORAD at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||18.4|4.5|0.002
70923586|NCT03526861|141338780|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|15.6|||<|0.001|TWO_SIDED|95.0|7.8|23.3||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 75% reduction in SCORAD at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||23.3|7.8|<0.001
70995644|NCT00077376|141500115|SUPERIORITY_OR_OTHER||Objective response rate|41.0|||||TWO_SIDED|95.0|26.0|58.0||||||||58|26|
70995645|NCT00077376|141500116|SUPERIORITY_OR_OTHER||Objective response rate|44.0|||||TWO_SIDED|95.0|31.0|58.0||||||||58|31|
70995646|NCT00880763|141500210|SUPERIORITY_OR_OTHER||Adjusted difference in percent|65.1|||<|0.001|TWO_SIDED|95.0|37.0|82.8|||Miettinen and Nurminen||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not).|||82.8|37.0|<0.001
70995647|NCT00880763|141500210|SUPERIORITY_OR_OTHER||Adjusted difference in percent|74.5|||<|0.001|TWO_SIDED|95.0|47.6|89.0|||Miettinen and Nurminen||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not).|||89.0|47.6|<0.001
71099976|NCT02037984|141708858|OTHER|PT6B GMC Ratio (V114/Prevnar 13®)|PT6B GMG Ratio|0.11|||||TWO_SIDED|95.0|0.05|0.23||||||||0.23|0.05|
71099977|NCT02037984|141708858|OTHER|PT7F GMC Ratio (V114/Prevnar 13®)|PT7F GMC Ratio|0.73|||||TWO_SIDED|95.0|0.51|1.04||||||||1.04|0.51|
71099978|NCT02037984|141708858|OTHER|PT9V GMC Ratio (V114/Prevnar 13®)|PT9V GMC Ratio|0.88|||||TWO_SIDED|95.0|0.59|1.3||||||||1.30|0.59|
71099979|NCT02037984|141708858|OTHER|PT14 GMC Ratio (V114/Prevnar®)|PT9V GMC Ratio|1.03|||||TWO_SIDED|95.0|0.66|1.6||||||||1.60|0.66|
71099980|NCT02037984|141708858|OTHER|PT18C GMC Ratio (V114/Prevnar 13®)|PT18C GMC Ratio|0.96|||||TWO_SIDED|95.0|0.66|1.39||||||||1.39|0.66|
71099981|NCT02037984|141708858|OTHER|PT19A GMC Ratio (V114/Prevnar 13®)|PT19A GMC Ratio|0.95|||||TWO_SIDED|95.0|0.64|1.39||||||||1.39|0.64|
71099982|NCT02037984|141708858|OTHER|PT19F GMC Ratio (V114/Prevnar 13®)|PT19F GMC Ratio|1.24|||||TWO_SIDED|95.0|0.84|1.84||||||||1.84|0.84|
71099983|NCT02037984|141708858|OTHER|PT23F GMC Ratio (V114/Prevnar 13®)|PT23F GMC Ratio|0.75|||||TWO_SIDED|95.0|0.46|1.23||||||||1.23|0.46|
71099984|NCT02037984|141708858|OTHER|non-PT22F GMC Ratio (V114/Prevnar 13®)|non-PT22F GMC Ratio|77.57|||||TWO_SIDED|95.0|51.6|116.6||||||||116.60|51.60|
71099985|NCT02037984|141708858|OTHER|non-PT33F GMC Ratio (V114/Prevnar 13®)|non-PT33F GMC Ratio|15.66|||||TWO_SIDED|95.0|8.46|28.98||||||||28.98|8.46|
71099986|NCT02037984|141708859|OTHER|PT1 GMC Ratio (V114/Prevnar 13®)|PT1 GMC Ratio|0.68|||||TWO_SIDED|95.0|0.5|0.93||||||||0.93|0.50|
71099987|NCT02037984|141708859|OTHER|PT3 GMC Ratio (V114/Prevnar 13®)|PT3 GMC Ratio|2.21|||||TWO_SIDED|95.0|1.62|3.02||||||||3.02|1.62|
71099988|NCT02037984|141708859|OTHER|PT4 GMC Ratio (V114/Prevnar 13®)|PT4 GMG Ratio|0.97|||||TWO_SIDED|95.0|0.71|1.31||||||||1.31|0.71|
71099989|NCT02037984|141708859|OTHER|PT5 GMC Ratio (V114/Prevnar 13®)|PT5 GMC Ratio|0.53|||||TWO_SIDED|95.0|0.36|0.79||||||||0.79|0.36|
71099990|NCT02037984|141708859|OTHER|PT6A GMC Ratio (V114/Prevnar 13®)|PT6A GMC Ratio|0.49|||||TWO_SIDED|95.0|0.26|0.94||||||||0.94|0.26|
71099991|NCT02037984|141708859|OTHER|PT6B GMC Ratio (V114/Prevnar 13®)|PT6B GMG Ratio|0.36|||||TWO_SIDED|95.0|0.17|0.77||||||||0.77|0.17|
71099992|NCT02037984|141708859|OTHER|PT7F GMC Ratio (V114/Prevnar 13®)|PT7F GMC Ratio|0.6|||||TWO_SIDED|95.0|0.42|0.85||||||||0.85|0.42|
71099993|NCT02037984|141708859|OTHER|PT9V GMC Ratio (V114/Prevnar 13®)|PT9V GMC Ratio|0.79|||||TWO_SIDED|95.0|0.54|1.16||||||||1.16|0.54|
71099994|NCT02037984|141708859|OTHER|PT14 GMC Ratio (V114/Prevnar®)|PT9V GMC Ratio|0.74|||||TWO_SIDED|95.0|0.48|1.14||||||||1.14|0.48|
71099995|NCT02037984|141708859|OTHER|PT18C GMC Ratio (V114/Prevnar 13®)|PT18C GMC Ratio|0.66|||||TWO_SIDED|95.0|0.46|0.95||||||||0.95|0.46|
71099996|NCT02037984|141708859|OTHER|PT19A GMC Ratio (V114/Prevnar 13®)|PT19A GMC Ratio|0.7|||||TWO_SIDED|95.0|0.48|1.02||||||||1.02|0.48|
71099997|NCT02037984|141708859|OTHER|PT19F GMC Ratio (V114/Prevnar 13®)|PT19F GMC Ratio|0.88|||||TWO_SIDED|95.0|0.6|1.29||||||||1.29|0.60|
71099998|NCT02037984|141708859|OTHER|PT23F GMC Ratio (V114/Prevnar 13®)|PT23F GMC Ratio|0.69|||||TWO_SIDED|95.0|0.43|1.12||||||||1.12|0.43|
71099999|NCT02037984|141708859|OTHER|non-PT22F GMC Ratio (V114/Prevnar 13®)|non-PT22F GMC Ratio|56.08|||||TWO_SIDED|95.0|37.66|83.52||||||||83.52|37.66|
71100000|NCT02037984|141708859|OTHER|non-PT33F GMC Ratio (V114/Prevnar 13®)|non-PT33F GMC Ratio|25.75|||||TWO_SIDED|95.0|14.18|46.78||||||||46.78|14.18|
71100001|NCT02037984|141708860|OTHER|PT1 GMC Ratio (V114/Prevnar 13®)|PT1 GMC Ratio|0.8|||||TWO_SIDED|95.0|0.58|1.09||||||||1.09|0.58|
71100002|NCT02037984|141708860|OTHER|PT3 GMC Ratio (V114/Prevnar 13®)|PT3 GMC Ratio|2.55|||||TWO_SIDED|95.0|1.86|3.49||||||||3.49|1.86|
71100003|NCT02037984|141708860|OTHER|PT4 GMC Ratio (V114/Prevnar 13®)|PT4 GMG Ratio|1.07|||||TWO_SIDED|95.0|0.79|1.46||||||||1.46|0.79|
71100004|NCT02037984|141708860|OTHER|PT5 GMC Ratio (V114/Prevnar 13®)|PT5 GMC Ratio|0.51|||||TWO_SIDED|95.0|0.34|0.76||||||||0.76|0.34|
71100005|NCT02037984|141708860|OTHER|PT6A GMC Ratio (V114/Prevnar 13®)|PT6A GMC Ratio|0.34|||||TWO_SIDED|95.0|0.17|0.65||||||||0.65|0.17|
71100006|NCT02037984|141708860|OTHER|PT6B GMC Ratio (V114/Prevnar 13®)|PT6B GMG Ratio|0.18|||||TWO_SIDED|95.0|0.08|0.38||||||||0.38|0.08|
71100007|NCT02037984|141708860|OTHER|PT7F GMC Ratio (V114/Prevnar 13®)|PT7F GMC Ratio|0.59|||||TWO_SIDED|95.0|0.41|0.84||||||||0.84|0.41|
71100008|NCT02037984|141708860|OTHER|PT9V GMC Ratio (V114/Prevnar 13®)|PT9V GMC Ratio|0.68|||||TWO_SIDED|95.0|0.46|1.01||||||||1.01|0.46|
71100009|NCT02037984|141708860|OTHER|PT14 GMC Ratio (V114/Prevnar®)|PT9V GMC Ratio|0.79|||||TWO_SIDED|95.0|0.51|1.22||||||||1.22|0.51|
71100010|NCT02037984|141708860|OTHER|PT18C GMC Ratio (V114/Prevnar 13®)|PT18C GMC Ratio|0.72|||||TWO_SIDED|95.0|0.5|1.05||||||||1.05|0.50|
71100011|NCT02037984|141708860|OTHER|PT19A GMC Ratio (V114/Prevnar 13®)|PT19A GMC Ratio|0.55|||||TWO_SIDED|95.0|0.37|0.8||||||||0.80|0.37|
71100012|NCT02037984|141708860|OTHER|PT19F GMC Ratio (V114/Prevnar 13®)|PT19F GMC Ratio|0.97|||||TWO_SIDED|95.0|0.66|1.44||||||||1.44|0.66|
71100013|NCT02037984|141708860|OTHER|PT23F GMC Ratio (V114/Prevnar 13®)|PT23F GMC Ratio|0.79|||||TWO_SIDED|95.0|0.49|1.28||||||||1.28|0.49|
71100014|NCT02037984|141708860|OTHER|non-PT22F GMC Ratio (V114/Prevnar 13®)|non-PT22F GMC Ratio|68.64|||||TWO_SIDED|95.0|45.81|102.84||||||||102.84|45.81|
71100015|NCT02037984|141708860|OTHER|non-PT33F GMC Ratio (V114/Prevnar 13®)|non-PT33F GMC Ratio|20.03|||||TWO_SIDED|95.0|10.88|36.88||||||||36.88|10.88|
71100016|NCT02037984|141708864|OTHER|PT1 Percentage Point Difference (V114 - Prevnar 13®)|PT1 Percentage Point Difference|-3.2|||||TWO_SIDED|95.0|-16.3|6.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.5|-16.3|
71100017|NCT02037984|141708864|OTHER|PT3 Percentage Point Difference (V114 - Prevnar 13®)|PT3 Percentage Point Difference|14.6|||||TWO_SIDED|95.0|-4.1|32.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||32.5|-4.1|
71100018|NCT02037984|141708864|OTHER|PT4 Percentage Point Difference (V114 - Prevnar 13®)|PT4 Percentage Point Difference|-7.0|||||TWO_SIDED|95.0|-22.8|5.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||5.7|-22.8|
71100019|NCT02037984|141708864|OTHER|PT5 Percentage Point Difference (V114 - Prevnar 13®)|PT5 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
71100020|NCT02037984|141708864|OTHER|PT6A Percentage Point Difference (V114 - Prevnar 13®)|PT6A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
71100021|NCT02037984|141708864|OTHER|PT6B Percentage Point Difference (V114 - Prevnar 13®)|PT6B Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
71100022|NCT02037984|141708864|OTHER|PT7F Percentage Point Difference (V114 - Prevnar 13®)|PT7F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
71100023|NCT02037984|141708864|OTHER|PT9V Percentage Point Difference (V114 - Prevnar 13®)|PT9V Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
71100024|NCT02037984|141708864|OTHER|PT14 Percentage Point Difference (V114 - Prevnar 13®)|PT14 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
70923587|NCT03526861|141338781|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|26.2|||<|0.001|TWO_SIDED|95.0|16.1|36.3||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 50% reduction in SCORAD at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||36.3|16.1|<0.001
70923588|NCT03526861|141338781|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|25.5|||<|0.001|TWO_SIDED|95.0|15.3|35.7||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 50% reduction in SCORAD at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||35.7|15.3|<0.001
70923589|NCT03526861|141338782|SUPERIORITY|The statistical test was not controlled for multiplicity.|Difference of least square means|-1.5|||<|0.001|TWO_SIDED|95.0|-2.4|-0.6||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-0.6|-2.4|<0.001
70923590|NCT03526861|141338782|SUPERIORITY|The statistical test was not controlled for multiplicity.|Difference of least square means|-1.2||||0.007|TWO_SIDED|95.0|-2.1|-0.3||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-0.3|-2.1|0.007
70923591|NCT03526861|141338783|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|20.3|||<|0.001|TWO_SIDED|95.0|9.7|31.0||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects with at least 3-point reduction in Adolescent Worst Pruritus NRS were considered responders. Subjects with missing data or who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||31.0|9.7|<0.001
70923592|NCT03526861|141338783|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|21.8|||<|0.001|TWO_SIDED|95.0|10.9|32.7||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects with at least 3-point reduction in Adolescent Worst Pruritus NRS were considered responders. Subjects with missing data or who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||32.7|10.9|<0.001
70923593|NCT03526861|141338784|SUPERIORITY|The statistical test was not controlled for multiplicity.|Difference of least square means|-6.0|||<|0.001|TWO_SIDED|95.0|-8.4|-3.6||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-3.6|-8.4|<0.001
70995648|NCT00880763|141500210|SUPERIORITY_OR_OTHER||Adjusted difference in percent|55.4|||<|0.001|TWO_SIDED|95.0|24.9|76.0|||Miettinen and Nurminen||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not).|||76.0|24.9|<0.001
71100025|NCT02037984|141708864|OTHER|PT18C Percentage Point Difference (V114 - Prevnar 13®)|PT18C Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
71100026|NCT02037984|141708864|OTHER|PT19A Percentage Point Difference (V114 - Prevnar 13®)|PT19A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
70995649|NCT00880763|141500211|SUPERIORITY_OR_OTHER||Adjusted difference in percent|4.8|||||TWO_SIDED|95.0|-11.3|24.2|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)|||24.2|-11.3|
71100027|NCT02037984|141708864|OTHER|PT19F Percentage Point Difference (V114 - Prevnar 13®)|PT19F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
71100028|NCT02037984|141708864|OTHER|PT23F Percentage Point Difference (V114 - Prevnar 13®)|PT23F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
70995650|NCT00880763|141500211|SUPERIORITY_OR_OTHER||Adjusted difference in percent|4.9|||||TWO_SIDED|95.0|-12.4|24.2|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)|||24.2|-12.4|
70995651|NCT00880763|141500211|SUPERIORITY_OR_OTHER||Adjusted difference in percent|4.8|||||TWO_SIDED|95.0|-12.0|24.2|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)|||24.2|-12.0|
70995652|NCT00880763|141500212|SUPERIORITY_OR_OTHER||Adjusted difference in percent|14.5|||||TWO_SIDED|95.0|-2.5|36.2|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)|||36.2|-2.5|
70995653|NCT00880763|141500212|SUPERIORITY_OR_OTHER||Adjusted difference in percent|14.6|||||TWO_SIDED|95.0|-3.4|36.3|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)|||36.3|-3.4|
70995654|NCT00880763|141500212|SUPERIORITY_OR_OTHER||Adjusted difference in percent|14.4|||||TWO_SIDED|95.0|-3.3|36.1|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)|||36.1|-3.3|
70995655|NCT00880763|141500213|SUPERIORITY_OR_OTHER||Difference in least squares mean|-1.8|||||TWO_SIDED|95.0|-2.3|-1.2|||||Computed using a longitudinal data analysis model including treatment, time and the interaction of time by treatment, with a restriction of the same baseline mean across treatment groups.|||-1.2|-2.3|
70995656|NCT00880763|141500213|SUPERIORITY_OR_OTHER||Difference in least squares mean|-1.9|||||TWO_SIDED|95.0|-2.4|-1.3|||||Computed using a longitudinal data analysis model including treatment, time and the interaction of time by treatment, with a restriction of the same baseline mean across treatment groups.|||-1.3|-2.4|
70995657|NCT00880763|141500213|SUPERIORITY_OR_OTHER||Difference in least squares mean|-1.6|||||TWO_SIDED|95.0|-2.2|-1.1|||||Computed using a longitudinal data analysis model including treatment, time and the interaction of time by treatment, with a restriction of the same baseline mean across treatment groups.|||-1.1|-2.2|
70995658|NCT01494987|141500226|SUPERIORITY_OR_OTHER||difference in least squares mean (LSM)|-0.51|||<|0.001|TWO_SIDED|95.0|-0.71|-0.32||P-value is from a mixed-effect model including terms for baseline HbA1c value, prior antihyperglycemia therapy, treatment group, visit week, and treatment by visit week interaction. Unstructured covariance matrix was used.|Mixed Effects Model Analysis||The estimation (LSM) is of the placebo-corrected change from baseline.|Assuming a common standard deviation of 1.2%, an effective sample size of 400 would provide at least 90% power to detect a statistically significant treatment difference of -0.5% (ranolazine vs. placebo) for the reduction of HbA1c from baseline at Week 24 based on a 2-sided alpha of 0.05 and 1:1 randomization.||-0.32|-0.71|<0.001
70995659|NCT02215616|141500247|OTHER||Least square (LS) mean difference|0.78||||0.4853|TWO_SIDED|95.0|-1.42|2.98||Threshold for significance at 0.045 level.|Mixed Models Analysis|||Analysis was performed using Mixed Model Repeated Measures model (MMRM) with treatment group (3 levels: placebo, laquinimod 0.5 mg and laquinimod 1 mg), categorical week (4 levels: Weeks 4, 13, 26, and 52), treatment by week interaction, country, TMS baseline value and TMS baseline by week interaction as fixed effects. Unstructured variance-covariance structure was used in the initial model.||2.98|-1.42|0.4853
70995660|NCT03532776|141500307|EQUIVALENCE|BE limits: -20.0% to 20.0%|Equivalence ratio|0.98|||||TWO_SIDED|90.0|-12.0|7.0||||||||7|-12|
70995661|NCT00654953|141500317|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|degrees of freedom for medication group = 2 (group)||The analysis tested the null hypothesis of no difference among groups in terms of the # of days to relapse (first two conseqcutively positive urines) using ANOVA.||||0.05
71100029|NCT02037984|141708864|OTHER|non-PT22F Percentage Point Difference (V114 - Prevnar 13®)|non-PT22F Percentage Point Difference|89.2|||||TWO_SIDED|95.0|75.2|95.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||95.7|75.2|
71100030|NCT02037984|141708864|OTHER|non-PT33F Percentage Point Difference (V114 - Prevnar 13®)|non-PT33F Percentage Point Difference|97.3|||||TWO_SIDED|95.0|85.1|99.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||99.5|85.1|
71100031|NCT02037984|141708865|OTHER|PT1 Percentage Point Difference (V114 - Prevnar 13®)|PT1 Percentage Point Difference|-4.2|||||TWO_SIDED|95.0|-20.4|5.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||5.6|-20.4|
71100032|NCT02037984|141708865|OTHER|PT3 Percentage Point Difference (V114 - Prevnar 13®)|PT3 Percentage Point Difference|11.8|||||TWO_SIDED|95.0|-10.0|30.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||30.6|-10.0|
71100033|NCT02037984|141708865|OTHER|PT4 Percentage Point Difference (V114 - Prevnar 13®)|PT4 Percentage Point Difference|-1.6|||||TWO_SIDED|95.0|-18.8|10.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||10.3|-18.8|
71100034|NCT02037984|141708865|OTHER|PT5 Percentage Point Difference (V114 - Prevnar 13®)|PT5 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
71100035|NCT02037984|141708865|OTHER|PT6A Percentage Point Difference (V114 - Prevnar 13®)|PT6A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.5|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.5|
71100036|NCT02037984|141708865|OTHER|PT6B Percentage Point Difference (V114 - Prevnar 13®)|PT6B Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.5|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.5|
71100037|NCT02037984|141708865|OTHER|PT7F Percentage Point Difference (V114 - Prevnar 13®)|PT7F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
71100038|NCT02037984|141708865|OTHER|PT9V Percentage Point Difference (V114 - Prevnar 13®)|PT9V Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
71100039|NCT02037984|141708865|OTHER|PT14 Percentage Point Difference (V114 - Prevnar 13®)|PT14 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
71100040|NCT02037984|141708865|OTHER|PT18C Percentage Point Difference (V114 - Prevnar 13®)|PT18C Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.5|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.5|
71100041|NCT02037984|141708865|OTHER|PT19A Percentage Point Difference (V114 - Prevnar 13®)|PT19A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
70995662|NCT01231607|141500318|SUPERIORITY_OR_OTHER||Least-squares (LS) mean difference|22.0||||0.046|TWO_SIDED|98.33|-4.4|48.4|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the dutasteride 0.02 mg LS mean minus the placebo LS mean.|||48.4|-4.4|0.046
70995663|NCT01231607|141500318|SUPERIORITY_OR_OTHER||LS mean difference|67.9|||<|0.001|TWO_SIDED|98.33|41.6|94.2|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the dutasteride 0.1 mg LS mean minus the placebo LS mean.|||94.2|41.6|<0.001
70995664|NCT01231607|141500318|SUPERIORITY_OR_OTHER||LS mean difference|94.4|||<|0.001|TWO_SIDED|98.33|67.8|121.0|||General linear model|Each dose of dutasteride independently analyzed for comparison against placebo using a general linear model.|Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the dutasteride 0.5 mg LS mean minus the placebo LS mean.|||121.0|67.8|<0.001
71040691|NCT02760433|141589987|SUPERIORITY||Risk Difference (RD)|0.283|||<|0.0001|TWO_SIDED|97.5|0.139|0.396|||Chi-squared|2x2 chi-square test||The DAS28 low disease activity (based on DAS28 \[CRP\] \<3.2) response rate at Week 12 was estimated to be 5% in the placebo group and 18% and 21% in 64 mg q4w and q2w OKZ groups, respectively, resulting in an expected difference of 13 and 16 percentage points between respective OKZ groups and placebo.||0.396|0.139|<0.0001
71100042|NCT02037984|141708865|OTHER|PT19F Percentage Point Difference (V114 - Prevnar 13®)|PT19F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
71100043|NCT02037984|141708865|OTHER|PT23F Percentage Point Difference (V114 - Prevnar 13®)|PT23F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
71040692|NCT02760433|141589988|SUPERIORITY||Least Squares Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.081|=|0.1814|TWO_SIDED|97.5|-0.26|0.11||p-value was greater than the threshold p-value of 0.0125|ANCOVA|||||0.11|-0.26|=0.1814
71040693|NCT02760433|141589988|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.083|=|0.0227|TWO_SIDED|97.5|-0.35|0.02||p-value was greater than the threshold p-value of 0.0125|ANCOVA|||||0.02|-0.35|=0.0227
71040694|NCT02760433|141589989|SUPERIORITY||Risk Difference (RD)|0.164|||||TWO_SIDED|97.5|0.02|0.278||Due to the hierarchical nature of pre-planned statistical testing (gate-keeping strategy) a formal statement could not be made||||||0.278|0.020|
71040695|NCT02760433|141589989|SUPERIORITY||Risk Difference (RD)|0.174|||||TWO_SIDED|97.5|0.027|0.294||Due to the hierarchical nature of pre-planned statistical testing (gate-keeping strategy) a formal statement could not be made||||||0.294|0.027|
71040696|NCT02760433|141589990|SUPERIORITY||Risk Difference (RD)|0.031|||||TWO_SIDED|97.5|-0.052|0.083||Due to the hierarchical nature of pre-planned statistical testing (gate-keeping strategy) a formal statement could not be made|||means continuity correction applied because expected cell counts \< 5|||0.083|-0.052|
71040697|NCT02760433|141589990|SUPERIORITY||Risk Difference (RD)|0.065|||||TWO_SIDED|97.5|-0.023|0.134||Due to the hierarchical nature of pre-planned statistical testing (gate-keeping strategy) a formal statement could not be made|||means continuity correction applied because expected cell counts \< 5|||0.134|-0.023|
71040698|NCT02151149|141589991|SUPERIORITY||Risk Ratio (RR)|1.01||||0.9258|TWO_SIDED|95.0|0.84|1.21|||Cochran-Mantel-Haenszel|Based on stratification factors of ECOG PS at screening (0 vs. 1) and histology (squamous cell carcinoma vs. non-squamous cell carcinoma).||||1.21|0.84|0.9258
71040699|NCT02151149|141589998|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.0036|TWO_SIDED|95.0|0.33|0.81|||Stratified Log Rank|Based on stratification factors of ECOG PS at screening (0 vs. 1) and histology (squamous cell carcinoma vs. non-squamous cell carcinoma).||||0.81|0.33|0.0036
71040700|NCT02151149|141589999|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.3537|TWO_SIDED|95.0|0.54|1.25|||Stratified log-rank test|Based on stratification factors of ECOG PS at screening (0 vs. 1) and histology (squamous cell carcinoma vs. non-squamous cell carcinoma).||||1.25|0.54|0.3537
71040701|NCT02151149|141590000|SUPERIORITY||Risk Ratio (RR)|1.56||||0.0597|TWO_SIDED|95.0|0.971|2.511|||Cochran-Mantel-Haenszel|Based on stratification factors of ECOG PS at screening (0 vs. 1) and histology (squamous cell carcinoma vs. non-squamous cell carcinoma)..||||2.511|0.971|0.0597
71040702|NCT00216060|141590002|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.08||||0.3|TWO_SIDED|95.0|0.51|8.4|||Regression, Cox|||||8.40|0.51|0.3
71040703|NCT00216060|141590003|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||univariate analysis|||||||0.12
71040704|NCT00216060|141590005|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
71040705|NCT00216060|141590007|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
71040706|NCT00216060|141590008|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Kruskal-Wallis|||||||0.010
71040707|NCT00216060|141590009|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
71040708|NCT02522780|141590027|SUPERIORITY||Odds Ratio (OR)|1.57|||>|0.05|TWO_SIDED|95.0|0.96|2.54||The p-value was based on Cochran-Mantel-Haenszel test by controlling pathway of randomization, at a 0.05 significance level.|Cochran-Mantel-Haenszel|||Proportions were compared between treatment groups at Month 6.||2.54|0.96|>0.05
71040709|NCT02522780|141590028|SUPERIORITY||Odds Ratio (OR)|1.24|||>|0.05|TWO_SIDED|95.0|0.76|2.03||The p-value was based on Generalized estimating equations (GEE) approach with binary outcomes (clinical remission) and an unstructured working correlation matrix, at a 0.05 significance level.|Generalised estimating equation approach|||Proportions were compared between treatment groups over 6 months.||2.03|0.76|>0.05
71100044|NCT02037984|141708865|OTHER|non-PT22F Percentage Point Difference (V114 - Prevnar 13®)|non-PT22F Percentage Point Difference|85.0|||||TWO_SIDED|95.0|65.8|93.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||93.6|65.8|
71100045|NCT02037984|141708865|OTHER|non-PT33F Percentage Point Difference (V114 - Prevnar 13®)|non-PT33F Percentage Point Difference|92.9|||||TWO_SIDED|95.0|75.1|98.1|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||98.1|75.1|
70995665|NCT01231607|141500318|SUPERIORITY_OR_OTHER||Least squares mean difference|61.4|||<|0.001|TWO_SIDED|98.33|34.4|88.4|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the placebo LS mean.|||88.4|34.4|<0.001
70995666|NCT01231607|141500318|NON_INFERIORITY_OR_EQUIVALENCE|Differences between dutasteride (DUT) and finasteride (FIN) were assessed using a general linear model (GLM) adjusted for treatment, cluster, and BL hair count (HC). The one-sided 99.165% confidence interval (CI) for DUT minus FIN was derived, and noninferiority (NI) demonstrated if the lower end of the CI was greater than -35 hairs. If NI was achieved with a dose of DUT, the primary endpoint was to be analyzed for superiority against FIN using a GLM adjusted for treatment, cluster, and BL HC.|Least squares mean difference|-39.4|||<|0.001||99.165|-66.1|-12.7|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.02 mg LS mean.|||-12.7|-66.1|<0.001
70995667|NCT01231607|141500318|NON_INFERIORITY_OR_EQUIVALENCE|Differences between dutasteride (DUT) and finasteride (FIN) were assessed using a general linear model (GLM) adjusted for treatment, cluster, and BL hair count (HC). The one-sided 99.165% confidence interval (CI) for DUT minus FIN was derived, and noninferiority (NI) demonstrated if the lower end of the CI was greater than -35 hairs. If NI was achieved with a dose of DUT, the primary endpoint was to be analyzed for superiority against FIN using a GLM adjusted for treatment, cluster, and BL HC.|Least squares mean difference|6.5||||0.28||99.165|-20.1|33.1|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.1 mg LS mean.|||33.1|-20.1|0.28
70995668|NCT01231607|141500318|NON_INFERIORITY_OR_EQUIVALENCE|Differences between dutasteride (DUT) and finasteride (FIN) were assessed using a general linear model (GLM) adjusted for treatment, cluster, and BL hair count (HC). The one-sided 99.165% confidence interval (CI) for DUT minus FIN was derived, and noninferiority (NI) demonstrated if the lower end of the CI was greater than -35 hairs. If NI was achieved with a dose of DUT, the primary endpoint was to be analyzed for superiority against FIN using a GLM adjusted for treatment, cluster, and BL HC.|Least squares mean difference|33.0||||0.002||99.165|6.1|60.0|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.5 mg LS mean.|||60|6.1|0.002
70995669|NCT01231607|141500318|SUPERIORITY_OR_OTHER||Least squares mean difference|-39.4|||<|0.001|TWO_SIDED|98.33|-66.1|-12.7|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.02 mg LS mean.|||-12.7|-66.1|<0.001
70995670|NCT01231607|141500318|SUPERIORITY_OR_OTHER||Least squares mean difference|6.5||||0.56|TWO_SIDED|98.33|-20.1|33.1|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.1 mg LS mean.|||33.1|-20.1|0.56
70995671|NCT01231607|141500318|SUPERIORITY_OR_OTHER||Least squares mean difference|33.0||||0.003|TWO_SIDED|98.33|6.1|60.0|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.5 mg LS mean.|||60|6.1|0.003
70995672|NCT02513771|141500363|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|Stratified Wilcoxon rank-sum test stratified by screening CD4 count (\<= or \> 350 cells/mm\^3) and statin use.||Null hypothesis: There is no difference between the two arms in the change in sCD14 from baseline to week 15/16.||||1.000
70995673|NCT01797445|141500379|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|3.1||||0.13|TWO_SIDED|95.002|-1.0|7.1|||Cochran-Mantel-Haenszel|P-value was from the Cochran-Mantel-Haenszel (CMH) test stratified by baseline HIV-1 RNA (≤ 100,000 or \> 100,000 copies/mL) and region (US vs ex-US).|The difference in percentages and its 95.002% confidence interval (CI) were calculated based on the Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA and region stratum.|Null hypothesis: the E/C/F/TAF group was ≥ 12% worse than the E/C/F/TDF group with respect to the percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48; alternative hypothesis: the E/C/F/TAF group was \< 12% worse than the E/C/F/TDF group.||7.1|-1.0|0.13
70995674|NCT01595438|141500396|NON_INFERIORITY_OR_EQUIVALENCE|-12.5%|Difference of symp resolution rates|4.0|||||TWO_SIDED|95.0|-2.39|10.42|||Unstratified Miettinen & Nurminen method|||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of symptomatic resolution rates ≤ non-inferiority margin||10.42|-2.39|
70995675|NCT01595438|141500397|NON_INFERIORITY_OR_EQUIVALENCE|-12.5%|Diff of favorable combined resp rates|6.7|||||TWO_SIDED|95.0|0.3|13.12|||Unstratified Miettinen & Nurminen method|||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable combined response rates ≤ non-inferiority margin||13.12|0.30|
70995676|NCT01595438|141500398|NON_INFERIORITY_OR_EQUIVALENCE|-12.5%|Diff of favorable response rates|6.4|||||TWO_SIDED|95.0|0.33|12.36|||Unstratified Miettinen & Nurminen method|||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates ≤ non-inferiority margin||12.36|0.33|
70995677|NCT01595438|141500399|SUPERIORITY_OR_OTHER||Diff of favorable response rates|0.4|||||TWO_SIDED|95.0|-2.7|3.56|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||3.56|-2.70|
70995678|NCT01595438|141500400|SUPERIORITY_OR_OTHER||Diff of favorable response rates|7.3|||||TWO_SIDED|95.0|0.68|13.81|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||13.81|0.68|
70995679|NCT01595438|141500401|SUPERIORITY_OR_OTHER||Diff of favorable response rates|0.2|||||TWO_SIDED|95.0|-1.21|1.72|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||1.72|-1.21|
70995680|NCT01595438|141500402|SUPERIORITY_OR_OTHER||Diff of favorable response rates|8.8|||||TWO_SIDED|95.0|2.27|15.24|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||15.24|2.27|
70995681|NCT01595438|141500403|SUPERIORITY_OR_OTHER||Diff of favorable response rates|10.9|||||TWO_SIDED|95.0|2.86|18.85|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||18.85|2.86|
70995682|NCT01595438|141500404|SUPERIORITY_OR_OTHER||Diff of favorable response rates|0.2|||||TWO_SIDED|95.0|-1.17|1.68|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||1.68|-1.17|
70995683|NCT01595438|141500405|SUPERIORITY_OR_OTHER||Diff of favorable response rates|7.3|||||TWO_SIDED|95.0|0.88|13.74|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||13.74|0.88|
70995684|NCT01595438|141500406|SUPERIORITY_OR_OTHER||Diff of favorable response rates|9.7|||||TWO_SIDED|95.0|1.72|17.55|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||17.55|1.72|
70923594|NCT03526861|141338784|SUPERIORITY|The statistical test was not controlled for multiplicity.|Difference of least square means|-5.4|||<|0.001|TWO_SIDED|95.0|-7.9|-3.0||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-3.0|-7.9|<0.001
70923595|NCT05862870|141338789|OTHER|Frequency count|exact count|20.0|STANDARD_DEVIATION|0.0||0.05|TWO_SIDED|0.0|20.0|20.0|||count|||Frequency count of patients retained in treatment.|Threshold for frequency count|20|20|.05
70923596|NCT00274469|141338793|NON_INFERIORITY|Study is powered basing on 20% deficiency in benefit rate for Fulvestrant compared to Anastrozole.|Odds Ratio (OR)|1.302||||0.386|TWO_SIDED|95.0|0.717|2.38||Null hypothesis: Fulvestrant has no difference with Anastrozole|Regression, Logistic||OR\>1 favours Fulvestrant|||2.380|0.717|0.386
70923597|NCT00274469|141338794|SUPERIORITY||Odds Ratio (OR)|1.021||||0.947|TWO_SIDED|95.0|0.556|1.874|||Regression, Logistic||OR\>1 favours Fulvestrant|||1.874|0.556|0.947
70923598|NCT00274469|141338795|SUPERIORITY||Hazard Ratio (HR)|0.6266||||0.0496|TWO_SIDED|95.0|0.3929|0.9991|||Log Rank||HR\<1 favours Fulvestrant|||0.9991|0.3929|0.0496
70923599|NCT00274469|141338796|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.05|TWO_SIDED|95.0|0.54|1.0|||Log Rank||HR\<1 favours Fulvestrant|||1.00|0.54|0.05
70995685|NCT01595438|141500407|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-1.4|||||TWO_SIDED|95.0|-4.07|1.02|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||1.02|-4.07|
70923600|NCT00274469|141338796|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.04|TWO_SIDED|95.0|0.52|0.98|||Regression, Cox|Cox regression analysis of TTTF controlling for baseline covariates.|HR\<1 favours Fulvestrant|||0.98|0.52|0.04
70923601|NCT00274469|141338797|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.01|TWO_SIDED|95.0|0.47|0.92|||Log Rank||HR\<1 favours Fulvestrant|||0.92|0.47|0.01
70923602|NCT00274469|141338797|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.01|TWO_SIDED|95.0|0.46|0.9|||Regression, Cox|Cox regression analysis of TTP (investigator assessed) controlling for baseline covariates.|HR\<1 favours Fulvestrant|||0.90|0.46|0.01
70923603|NCT00274469|141338798|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.041|TWO_SIDED|95.0|0.5|0.98|||Log Rank|||||0.98|0.50|0.041
70923604|NCT00274469|141338798|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.126|TWO_SIDED|95.0|0.54|1.08|||Regression, Cox|Cox regression analysis of OS controlling for baseline covariates|HR\<1 favours Fulvestrant|||1.08|0.54|0.126
70923605|NCT06647238|141338805|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
70923606|NCT02910713|141338879|SUPERIORITY||Least Squares Mean Difference|-13.36|STANDARD_ERROR_OF_MEAN|1.999|<|0.0001|TWO_SIDED|95.0|-17.31|-9.4||One-sided p-value for the difference between Intranasal and Extranasal.|ANOVA|||||-9.40|-17.31|<0.0001
70923607|NCT02910713|141338880|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.101|<|0.0001|TWO_SIDED|95.0|-0.8|-0.4||One-sided p-value for the difference between Intranasal and Extranasal.|ANOVA|||||-0.40|-0.80|<0.0001
70923608|NCT05338086|141338916|EQUIVALENCE|The estimated mean difference in %CfB lumbar spine BMD at Month 12 was presented with 95% CI and equivalence was concluded if this fell within the predefined equivalence margin of \[-1.45%, 1.45%\].|Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.51|0.91||Mixed-model for repeated measures (MMRM)|Mixed Models Analysis|MMRM included treatment, with stratification variables as classification factors and baseline BMD as a continuous covariate.||||0.91|-0.51|
70923609|NCT05338086|141338917|EQUIVALENCE|The estimated mean difference in %CfB lumbar spine BMD at Month 12 was presented with 95% CI and equivalence was concluded if this fell within the predefined equivalence margin of \[-1.45%, 1.45%\].|Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-0.69|0.74|||ANCOVA|ANCOVA included terms for treatment, with stratification variables as classification factors and baseline BMD included as a continuous covariate.|The estimated mean difference in %CfB lumbar spine BMD results was pooled using Rubin's methods and presented with 95% CI.|||0.74|-0.69|
70995686|NCT01595438|141500408|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-0.1|||||TWO_SIDED|95.0|-4.23|4.03|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||4.03|-4.23|
70995687|NCT01595438|141500409|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|1.3|||||TWO_SIDED|95.0|-3.71|6.3|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||6.30|-3.71|
70923610|NCT05338086|141338920|EQUIVALENCE|Equivalence criteria (analysis set mFAS): 95% CI for ratio of geometric LS mean ratios contained in acceptance limits (80.00%, 125.00%).|Ratio of Geometric means|99.91|||||TWO_SIDED|95.0|91.99|108.52|||ANCOVA|ANCOVA model including log-transformed baseline sCTX as a continuous covariate with treatment and stratification variables as fixed effects.||||108.52|91.99|
70923611|NCT05338086|141338921|EQUIVALENCE|Biosimilarity with respect to PD was concluded if the 95% CI for the test (MB09) to reference (EU-Prolia) ratios of the geometric LS means was contained within the \[80.00%, 125.00%\] interval.|Ratio of Geometric means|99.13|||||TWO_SIDED|95.0|96.31|102.02|||ANCOVA|||||102.02|96.31|
70923612|NCT05338086|141338922|EQUIVALENCE|Equivalence criteria (on Pharmacokinetic Parameter Analysis Set): the 95% CIs around the geometric LS mean contained in the acceptance limits (80.00%, 125.00%)|LS Geometric Mean Ratio|104.13|||||TWO_SIDED|95.0|98.83|109.71|||ANCOVA|Cmax was analysed on the log scale by ANCOVA. The model included treatment and stratification variables as fixed effects.||||109.71|98.83|
70923613|NCT05338086|141338923|EQUIVALENCE|Equivalence criteria (on Pharmacokinetic Parameter Analysis Set): the 95% CIs around the geometric LS mean contained in the acceptance limits (80.00%, 125.00%)|LS Geometric Mean Ratio|106.06|||||TWO_SIDED|95.0|99.84|112.66|||ANCOVA|AUC0-6 months was analysed on the log scale by ANCOVA. The model included treatment and stratification variables as fixed effects.||||112.66|99.84|
70923614|NCT05386355|141338970|SUPERIORITY||Risk Ratio (RR)|1.79|||||TWO_SIDED|95.0|0.59|5.35|||||The General Health App is the reference group.|A mixed-effect Poisson regression with robust variance estimation was used report the adjusted RR with 95% CI accounting for the clinic-specific random intercepts. Given the small number of COVID-19 vaccination completion, we were unable to account for children nested with parent/caregiver or adjusting for covariates.||5.35|0.59|
70923615|NCT05386355|141338971|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.42|1.65|||||The General Health App is the reference group.|A mixed-effect Poisson regression with robust variance estimation was used report the adjusted RR with 95% CI accounting for the clinic-specific random intercepts. Given the small number of COVID-19 vaccination completion, we were unable to account for children nested with parent/caregiver or adjusting for covariates.||1.65|0.42|
70923616|NCT05386355|141338972|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.638|TWO_SIDED|95.0|-1.19|0.73|||Mixed Models Analysis|The analytical method was based on a linear mixed model adjusting for baseline SAGE vaccine hesitancy composite scores and random clinic effect.||||0.73|-1.19|0.638
70923617|NCT06143670|141338973|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12 (Test for non-zero within group change from Baseline)||||<0.0001
70923618|NCT06143670|141338974|SUPERIORITY||Adjusted Mean Difference|-16.9|STANDARD_ERROR_OF_MEAN|1.4|<|0.0001|TWO_SIDED|95.0|-19.6|-14.1|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-14.1|-19.6|<0.0001
70995688|NCT01595438|141500410|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-1.3|||||TWO_SIDED|95.0|-3.64|0.55|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||0.55|-3.64|
70923619|NCT06143670|141338975|SUPERIORITY||Adjusted Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|1.46|<|0.0001|TWO_SIDED|95.0|-18.9|-13.1|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-13.1|-18.9|<0.0001
70923620|NCT06143670|141338975|SUPERIORITY||Adjusted Mean Difference|-17.6|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-19.9|-15.3|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-15.3|-19.9|<0.0001
70923621|NCT06143670|141338976|SUPERIORITY||Adjusted Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001|TWO_SIDED|95.0|-0.35|-0.2|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.20|-0.35|<0.0001
70923622|NCT06143670|141338976|SUPERIORITY||Adjusted Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|-0.26|-0.13|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.13|-0.26|<0.0001
70923623|NCT06143670|141338976|SUPERIORITY||Adjusted Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|-0.36|-0.22|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.22|-0.36|<0.0001
70923624|NCT06143670|141338977|SUPERIORITY||Adjusted Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|-0.28|-0.16|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.16|-0.28|<0.0001
70923625|NCT06143670|141338977|SUPERIORITY||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|-0.21|-0.1|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.10|-0.21|<0.0001
70923626|NCT06143670|141338977|SUPERIORITY||Adjusted Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|-0.3|-0.18|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.18|-0.30|<0.0001
70923627|NCT06143670|141338978|SUPERIORITY||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|-0.15|-0.1|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.10|-0.15|<0.0001
70923628|NCT06143670|141338978|SUPERIORITY||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.17|-0.13|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.13|-0.17|<0.0001
70923629|NCT06143670|141338978|SUPERIORITY||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|-0.16|-0.11|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.11|-0.16|<0.0001
70995689|NCT01595438|141500411|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|1.2|||||TWO_SIDED|95.0|-2.03|4.56|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||4.56|-2.03|
70995690|NCT01595438|141500412|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|2.2|||||TWO_SIDED|95.0|-2.9|7.24|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||7.24|-2.90|
70995691|NCT01595438|141500413|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-1.9|||||TWO_SIDED|95.0|-4.3|0.04|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||0.04|-4.30|
70995692|NCT01595438|141500414|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|1.1|||||TWO_SIDED|95.0|-2.07|4.32|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||4.32|-2.07|
70995693|NCT01595438|141500415|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|2.0|||||TWO_SIDED|95.0|-2.94|6.91|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||6.91|-2.94|
70995694|NCT01595438|141500416|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-0.1|||||TWO_SIDED|95.0|-1.99|1.61|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||1.61|-1.99|
70995695|NCT01595438|141500417|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|3.7|||||TWO_SIDED|95.0|0.41|7.16|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||7.16|0.41|
70995696|NCT01595438|141500418|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|4.0|||||TWO_SIDED|95.0|-1.0|9.05|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||9.05|-1.00|
70995697|NCT01595438|141500419|SUPERIORITY_OR_OTHER||Diff of clin cure rates in All patients|0.0|||||TWO_SIDED|95.0|-10.4|10.1|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen||10.1|-10.4|
70995698|NCT01595438|141500420|SUPERIORITY_OR_OTHER||Diff of clin cure rates in All patients|1.4|||||TWO_SIDED|95.0|-7.8|10.2|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen||10.2|-7.8|
70995699|NCT01595438|141500421|SUPERIORITY_OR_OTHER||Diff of clin cure rates in All patients|1.2|||||TWO_SIDED|95.0|-7.5|9.2|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen||9.2|-7.5|
70995700|NCT01595438|141500422|SUPERIORITY_OR_OTHER||Diff of favorable response rates|2.0|||||TWO_SIDED|95.0|-13.18|16.89|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||16.89|-13.18|
70995701|NCT01595438|141500423|SUPERIORITY_OR_OTHER||Diff of favorable response rates|8.0|||||TWO_SIDED|95.0|-10.03|25.21|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||25.21|-10.03|
70995702|NCT01595438|141500424|SUPERIORITY_OR_OTHER||Diff of favorable response rates|7.5|||||TWO_SIDED|95.0|-9.91|24.01|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||24.01|-9.91|
70995703|NCT01595438|141500425|SUPERIORITY_OR_OTHER|||||||0.038|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.038
70995704|NCT01595438|141500426|SUPERIORITY_OR_OTHER|||||||0.129|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.129
70995705|NCT01595438|141500427|SUPERIORITY_OR_OTHER|||||||0.08|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.080
70995706|NCT01595438|141500428|SUPERIORITY_OR_OTHER|||||||0.155|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.155
70995707|NCT04904614|141500477|SUPERIORITY|||||||0.02|||||||Fisher Exact|||||||0.02
70995708|NCT04904614|141500478|SUPERIORITY|||||||0.13|||||||Chi-squared|||||||0.13
70995709|NCT04904614|141500479|SUPERIORITY|||||||0.6|||||||Fisher Exact|||||||0.6
70995710|NCT04904614|141500481|SUPERIORITY|||||||0.97|||||||Chi-squared|||||||0.97
70995711|NCT04190186|141500483|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.594|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.594
70995712|NCT04015440|141500494|OTHER|Linear Regression|||||<|0.001|||||||Regression, Linear|||||||<.001
70995713|NCT04015440|141500495|OTHER|Regression||||||0.027|||||||Regression, Linear|||||||.027
70995714|NCT04015440|141500496|OTHER|Logistic Regression||||||0.004|||||||Regression, Logistic|||||||.004
70995715|NCT01668030|141500498|SUPERIORITY|||||||0.0853|||||||t-test, 2 sided|||||||.0853
70995716|NCT00618995|141500499|NON_INFERIORITY_OR_EQUIVALENCE|Two treatments are comparable if the geometric mean ratio (GMR) is contained within the interval \[0.50-2.00\].|Geometric least-squares mean ratio|0.97||||||90.0|0.8|1.18||||||The endpoint is the urine levels of 11-dTxB2 on Day 7 following a 7 day course of daily dosing in the overall 24 hour collection interval. The point estimate and 90% confidence intervals (CIs) were calculated for the geometric mean ratio (GMR) \[Treatment A/B\] of the urine levels of 11-dTxB2 on Day 7.||1.18|0.8|
71040710|NCT02522780|141590029|SUPERIORITY||Hazard Ratio (HR)|0.6|||>|0.05|TWO_SIDED|95.0|0.25|1.44||The p-value was based on log-rank test using pathway of randomization as the stratification factor, at a 0.05 significance level.|Log Rank|||Times to relapse were compared between treatment groups up to 6 months.||1.44|0.25|>0.05
71040711|NCT02522780|141590030|SUPERIORITY||Odds Ratio (OR)|0.39|||<|0.05|TWO_SIDED|95.0|0.19|0.79||The p-value was based on Cochran-Mantel-Haenszel test by controlling pathway of randomization, at a 0.05 significance level.|Cochran-Mantel-Haenszel|||Proportions were compared between treatment groups at Month 6.||0.79|0.19|<0.05
71040712|NCT02522780|141590031|SUPERIORITY||Mean difference|-1.0|||>|0.05|TWO_SIDED|95.0|-2.7|0.7||The p-value was based on a repeated-measures analysis of covariance (ANCOVA) model with an unstructured correlation matrix , at a 0.05 significance level.|ANCOVA|||Adjusted mean treatment difference in CRP levels over 6 months was reported.||0.7|-2.7|>0.05
71040713|NCT02522780|141590032|SUPERIORITY||Mean difference|-66.92|||>|0.05|TWO_SIDED|95.0|-140.2|6.36||The p-value was based on a repeated-measures ANCOVA model with an unstructured correlation matrix, at a 0.05 significance level.|ANCOVA|||Adjusted mean treatment difference in fecal calprotectin levels over 6 months was reported.||6.36|-140.2|>0.05
71040714|NCT02522780|141590033|SUPERIORITY||Mean difference|-0.32|||>|0.05|TWO_SIDED|95.0|-4.41|3.77||The p-value was based on a repeated-measures ANCOVA model with an unstructured correlation matrix, at a 0.05 significance level.|ANCOVA|||Adjusted mean treatment difference in IBDQ total scores over 6 months was reported.||3.77|-4.41|>0.05
71040715|NCT02058160|141590039|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.633|-0.397||Threshold for significance at 0.05 level.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Analysis was performed using Mixed-effect model with repeated measures (MMRM) with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of metformin use at screening, visits, treatment-by-visit interaction and country as fixed effects and baseline HbA1c value-by-visit interaction as covariates. A hierarchical testing procedure was used to control type I error and handle multiple endpoint analyses.||-0.397|-0.633|<0.0001
71100046|NCT02037984|141708866|OTHER|PT1 Percentage Point Difference (V114 - Prevnar 13®)|PT1 Percentage Point Difference|-3.0|||||TWO_SIDED|95.0|-15.5|6.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.7|-15.5|
71100047|NCT02037984|141708866|OTHER|PT3 Percentage Point Difference (V114 - Prevnar 13®)|PT3 Percentage Point Difference|24.3|||||TWO_SIDED|95.0|12.6|40.2|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||40.2|12.6|
71100048|NCT02037984|141708866|OTHER|PT4 Percentage Point Difference (V114 - Prevnar 13®)|PT4 Percentage Point Difference|2.7|||||TWO_SIDED|95.0|-8.0|14.0|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||14.0|-8.0|
71100049|NCT02037984|141708866|OTHER|PT5 Percentage Point Difference (V114 - Prevnar 13®)|PT5 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
71040716|NCT02058160|141590040|SUPERIORITY_OR_OTHER||Difference in percentage|25.52|||<|0.0001|TWO_SIDED|95.0|18.94|32.1||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|"HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs Insulin Glargine.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of metformin use at screening. This analysis was out of testing order."||32.10|18.94|<0.0001
71040717|NCT02058160|141590040|SUPERIORITY_OR_OTHER||Difference in percentage|19.76|||<|0.0001|TWO_SIDED|95.0|13.9|25.62|||Cochran-Mantel-Haenszel||HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|"HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Insulin Glargine.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of metformin use at screening. This analysis was out of testing order."||25.62|13.90|<0.0001
71040718|NCT02058160|141590041|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.43|STANDARD_ERROR_OF_MEAN|0.251|<|0.0001|TWO_SIDED|95.0|-3.925|-2.939||Threshold for significance at 0.05 level.|ANCOVA||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of metformin use at screening and country as fixed effects and baseline 2-hour plasma glucose excursion value as a covariate.||-2.939|-3.925|<0.0001
71100050|NCT02037984|141708866|OTHER|PT6A Percentage Point Difference (V114 - Prevnar 13®)|PT6A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
71100051|NCT02037984|141708866|OTHER|PT6B Percentage Point Difference (V114 - Prevnar 13®)|PT6B Percentage Point Difference|-3.0|||||TWO_SIDED|95.0|-15.5|6.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.7|-15.5|
71100052|NCT02037984|141708866|OTHER|PT7F Percentage Point Difference (V114 - Prevnar 13®)|PT7F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
71100053|NCT02037984|141708866|OTHER|PT9V Percentage Point Difference (V114 - Prevnar 13®)|PT9V Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
71100054|NCT02037984|141708866|OTHER|PT14 Percentage Point Difference (V114 - Prevnar 13®)|PT14 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
70995717|NCT00618995|141500499|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.94||||||90.0|0.77|1.14||||||||1.14|0.77|
70995718|NCT00618995|141500499|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.87||||||90.0|0.71|1.05||||||||1.05|0.71|
70995719|NCT00618995|141500499|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.84||||||90.0|0.69|1.02||||||||1.02|0.69|
70995720|NCT00618995|141500499|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.92||||||90.0|0.76|1.13||||||||1.13|0.76|
70995721|NCT00618995|141500499|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.9||||||90.0|0.74|1.09||||||||1.09|0.74|
70995722|NCT00618995|141500500|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.94||||||90.0|0.84|1.06||||||||1.06|0.84|
70995723|NCT00618995|141500500|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.94||||||90.0|0.84|1.05||||||||1.05|0.84|
70995724|NCT00618995|141500500|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.57||||||90.0|0.51|0.64||||||||0.64|0.51|
70995725|NCT00618995|141500500|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.54||||||90.0|0.48|0.6||||||||0.60|0.48|
70995726|NCT00618995|141500500|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.6||||||90.0|0.54|0.67||||||||0.67|0.54|
70995727|NCT00618995|141500500|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.57||||||90.0|0.51|0.64||||||||0.64|0.51|
70995728|NCT03373110|141500504|OTHER|||||||0.973||||||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|||We used linear mixed effects models fit via maximum likelihood to examine the effect of the interventions on daily steps. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction. We used separate models to assess the intervention effects across the 8-week intervention period as well as the complete 16-week follow-up period.|The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|||0.973
70995729|NCT03373110|141500504|OTHER|||||||0.005||||||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|||We used linear mixed effects models to examine the effect of the interventions on average daily steps at 8 weeks into the study. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|We used linear mixed effects models to examine the effect of the interventions on daily steps. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to account for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|||.005
71100055|NCT02037984|141708866|OTHER|PT18C Percentage Point Difference (V114 - Prevnar 13®)|PT18C Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
71100056|NCT02037984|141708866|OTHER|PT19A Percentage Point Difference (V114 - Prevnar 13®)|PT19A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
70995730|NCT03373110|141500504|OTHER|||||||0.004||||||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|||We used linear mixed effects models to examine the effect of the interventions on average daily steps at 8 weeks into the study. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|We used linear mixed effects models to examine the effect of the interventions on daily steps. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to account for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|||.004
71100057|NCT02037984|141708866|OTHER|PT19F Percentage Point Difference (V114 - Prevnar 13®)|PT19F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
70995731|NCT03373110|141500504|OTHER|||||||0.627||||||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|||We used linear mixed effects models to examine the effect of the interventions on average daily steps at 16 weeks into the study. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|We used linear mixed effects models to examine the effect of the interventions on daily steps. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to account for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|||0.627
70995732|NCT03373110|141500504|OTHER|||||||0.359||||||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|||We used linear mixed effects models to examine the effect of the interventions on average daily steps at 16 weeks into the study. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|We used linear mixed effects models to examine the effect of the interventions on daily steps. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to account for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|||0.359
71100058|NCT02037984|141708866|OTHER|PT23F Percentage Point Difference (V114 - Prevnar 13®)|PT23F Percentage Point Difference|-3.0|||||TWO_SIDED|95.0|-15.5|6.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.7|-15.5|
71100059|NCT02037984|141708866|OTHER|non-PT22F Percentage Point Difference (V114 - Prevnar 13®)|non-PT22F Percentage Point Difference|89.2|||||TWO_SIDED|95.0|75.2|95.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||95.7|75.2|
71100060|NCT02037984|141708866|OTHER|non-PT33F Percentage Point Difference (V114 - Prevnar 13®)|non-PT33F Percentage Point Difference|97.3|||||TWO_SIDED|95.0|85.7|99.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||99.5|85.7|
70923630|NCT06143670|141338979|SUPERIORITY||Adjusted Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001|TWO_SIDED|95.0|-0.74|-0.53|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.53|-0.74|<0.0001
70923631|NCT06143670|141338979|SUPERIORITY||Adjusted Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|-0.74|-0.56|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.56|-0.74|<0.0001
70923632|NCT06143670|141338979|SUPERIORITY||Adjusted Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001|TWO_SIDED|95.0|-0.77|-0.58|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.58|-0.77|<0.0001
70923633|NCT03775109|141338987|SUPERIORITY||Mean Difference (Net)|16.7||||0.248|TWO_SIDED|95.0|-11.2|44.5||The threshold for statistical significance was p = 0.05|Chi-squared||Difference = Canakinumab - Placebo|It is estimated that improvement of histological alcoholic steatohepatitis will occur in 40% of patients treated with placebo and 80% of patients treated with Canakinumab. A trial with 80% power to detect a difference at the P \< 0.05 threshold would require 23 patients in each arm, 46 in total. Assuming a drop-out rate of 10%, we will recruit 52 patients in total (26 patients per group).||44.5|-11.2|0.248
70923634|NCT03775109|141338988|SUPERIORITY||Mean Difference (Net)|0.043|||||TWO_SIDED|95.0|-0.235|0.322|||||Difference = Canakinumab - Placebo|||0.322|-0.235|
70923635|NCT03775109|141338989|SUPERIORITY||Odds Ratio (OR)|3.133|||||TWO_SIDED|95.0|0.121|81.004||||||||81.004|0.121|
70923636|NCT03775109|141338990|SUPERIORITY||Odds Ratio (OR)|1.887|||||TWO_SIDED|95.0|0.357|9.965||||||||9.965|0.357|
70923637|NCT03775109|141338993|SUPERIORITY|||||||0.27|||||||ANCOVA|Change in log-transformed serum bilirubin from baseline to day 28. 49 participants were included in this analysis.||||||0.270
70995733|NCT03373110|141500504|OTHER|||||||0.597||||||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|||We used linear mixed effects models to examine the effect of the interventions on average daily steps at 16 weeks into the study. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|We used linear mixed effects models to examine the effect of the interventions on daily steps. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to account for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|||0.597
70995734|NCT01804036|141500526|SUPERIORITY_OR_OTHER|||||||0.84|||||||ANCOVA|||||||0.84
70923638|NCT03775109|141338994|SUPERIORITY|||||||0.0349|||||||ANCOVA|ANCOVA model: MELD score at Day 28 = intercept + treatment group indicator + baseline MELD score. 49 patients have data at Day 28 and baseline.||||||0.03490
70923639|NCT03775109|141338995|SUPERIORITY||Odds Ratio (OR)|5.088|||||TWO_SIDED|95.0|1.558|16.624|||||Ordinal logistic regression (proportional odds) model. GAHS at day 28 = intercept + treatment group indicator + baseline GAHS measurement. 48 participants have GAHS data at baseline and day 28.|||16.624|1.558|
70923640|NCT03775109|141338996|SUPERIORITY|||||||0.343|||||||ANCOVA|ANCOVA model: mDF score at day 28 = intercept + treatment group indicator + baseline mDF score.||Natural log transformation used for both baseline and day 28 measurements. 49 participants have mDF measurements at baseline and day 28.||||0.343
70923641|NCT03775109|141338997|SUPERIORITY||Mean Difference (Net)|0.083|||||TWO_SIDED|95.0|-0.529|0.696|||||difference = canakinumab - placebo. natural log transformation used.|||0.696|-0.529|
70923642|NCT03775109|141338998|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
70923643|NCT03775109|141338999|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
70923644|NCT03775109|141339000|SUPERIORITY||Cox Proportional Hazard|1.046|||||TWO_SIDED|95.0|0.147|7.424||||||||7.424|0.147|
70923645|NCT03775109|141339008|SUPERIORITY||Mean Difference (Net)|0.043|||||TWO_SIDED|95.0|-0.235|0.322|||||Difference = Canakinumab - Placebo|||0.322|-0.235|
70923646|NCT03775109|141339009|SUPERIORITY||Mean Difference (Net)|-0.13|||||TWO_SIDED|95.0|-0.388|0.127|||||Difference = Canakinumab - Placebo|||0.127|-0.388|
70923647|NCT03775109|141339010|SUPERIORITY||Odds Ratio (OR)|4.012|||||TWO_SIDED|95.0|0.693|23.219||||||||23.219|0.693|
70923648|NCT03775109|141339011|SUPERIORITY||Odds Ratio (OR)|4.543|||||TWO_SIDED|95.0|0.543|38.043||||||||38.043|0.543|
70923649|NCT03775109|141339012|SUPERIORITY||Odds Ratio (OR)|1.745|||||TWO_SIDED|95.0|0.456|6.558||||||||6.558|0.456|
70923650|NCT03775109|141339013|SUPERIORITY||Odds Ratio (OR)|0.977|||||TWO_SIDED|95.0|0.281|3.397||||||||3.397|0.281|
70923651|NCT03775109|141339014|SUPERIORITY||Odds Ratio (OR)|0.768|||||TWO_SIDED|95.0|0.238|2.479||||||||2.479|0.238|
70923652|NCT05691452|141339028|SUPERIORITY||Mean Difference (Net)|20.05||||0.578|TWO_SIDED|95.0|-50.68|90.78||Generalized linear models generated estimated mean differences in the post-intervention values controlling for the baseline assessments.|Regression, Linear|||||90.78|-50.68|0.578
70923653|NCT05691452|141339029|SUPERIORITY||Mean Difference (Net)|-21.2||||0.61|TWO_SIDED|95.0|-101.9|59.5|||Regression, Linear|||||59.5|-101.9|0.61
70923654|NCT05691452|141339030|SUPERIORITY||Mean Difference (Net)|1.55||||0.674|TWO_SIDED|95.0|-5.68|8.78|||Regression, Linear|||||8.78|-5.68|0.674
70923655|NCT05691452|141339031|SUPERIORITY||Mean Difference (Net)|-21.6||||0.013|TWO_SIDED|95.0|-38.5|-4.59|||Regression, Linear|||||-4.59|-38.5|.013
70923656|NCT05691452|141339032|SUPERIORITY||Mean Difference (Net)|0.387||||0.29|TWO_SIDED|95.0|-0.335|1.109|||Regression, Linear|||||1.109|-0.335|0.29
70923657|NCT05691452|141339033|SUPERIORITY||Mean Difference (Net)|-0.203||||0.701|TWO_SIDED|95.0|-1.24|0.833|||Regression, Linear|||||0.833|-1.24|0.701
70923658|NCT05691452|141339034|SUPERIORITY||Mean Difference (Net)|-21.45||||0.376|TWO_SIDED|95.0|-68.99|26.08|||Regression, Linear|||||26.08|-68.99|0.376
70923659|NCT03467542|141339058|OTHER||||||||||||||||||The total number evaluated, the percent, and the Clopper-Pearson two-sided 95% confidence limits on the percent.|||
70923660|NCT04549168|141339087|SUPERIORITY||LS geometric mean ratio|0.795||||0.0585|TWO_SIDED|95.0|0.627|1.008||Data was analyzed using mixed effect model repeated measurement analysis (MMRM), and the missing values were imputed using multiple imputation and assumed to be missing not at random (MNAR).|MMRM|||||1.008|0.627|0.0585
70923661|NCT04549168|141339088|SUPERIORITY||LSM difference|7.1|||<|0.0001|TWO_SIDED|95.0|4.39|9.81||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||9.81|4.39|<0.0001
70923662|NCT04549168|141339089|SUPERIORITY||LSM difference|-17.84||||0.0002|TWO_SIDED|95.0|-27.16|-8.51||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||-8.51|-27.16|0.0002
70923663|NCT04549168|141339090|SUPERIORITY||LS geometric mean ratio|0.776||||0.0063|TWO_SIDED|95.0|0.647|0.93||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||0.930|0.647|0.0063
71100061|NCT02037984|141708867|OTHER|PT1 Percentage Point Difference (V114 - Prevnar 13®)|PT1 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
71100062|NCT02037984|141708867|OTHER|PT3 Percentage Point Difference (V114 - Prevnar 13®)|PT3 Percentage Point Difference|18.4|||||TWO_SIDED|95.0|1.7|35.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||35.5|1.7|
71100063|NCT02037984|141708867|OTHER|PT4 Percentage Point Difference (V114 - Prevnar 13®)|PT4 Percentage Point Difference|-14.9|||||TWO_SIDED|95.0|-31.4|-1.2|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||-1.2|-31.4|
71100064|NCT02037984|141708867|OTHER|PT5 Percentage Point Difference (V114 - Prevnar 13®)|PT5 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
71100065|NCT02037984|141708867|OTHER|PT6A Percentage Point Difference (V114 - Prevnar 13®)|PT6A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
71100066|NCT02037984|141708867|OTHER|PT6B Percentage Point Difference (V114 - Prevnar 13®)|PT6B Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
71100067|NCT02037984|141708867|OTHER|PT7F Percentage Point Difference (V114 - Prevnar 13®)|PT7F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
70923664|NCT04549168|141339091|SUPERIORITY||LSM difference|4.49||||0.0242|TWO_SIDED|95.0|0.59|8.39||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||8.39|0.59|0.0242
70923665|NCT04549168|141339092|SUPERIORITY||LSM difference|-10.36||||0.1625|TWO_SIDED|95.0|-24.95|4.22||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||4.22|-24.95|0.1625
70923666|NCT04549168|141339093|SUPERIORITY||LS geometric mean ratio|0.815||||0.0515|TWO_SIDED|95.0|0.663|1.001||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||1.001|0.663|0.0515
70923667|NCT04549168|141339094|SUPERIORITY||LSM difference|7.74|||<|0.0001|TWO_SIDED|95.0|5.61|9.86||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||9.86|5.61|<0.0001
70923668|NCT04549168|141339095|SUPERIORITY||LSM difference|-21.25|||<|0.0001|TWO_SIDED|95.0|-28.15|-14.35||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||-14.35|-28.15|<0.0001
70923669|NCT04549168|141339097|SUPERIORITY||LSM difference|-2.85|STANDARD_ERROR_OF_MEAN|0.811||0.0006|TWO_SIDED|95.0|-4.45|-1.25||Based on Analysis of Covariance (ANCOVA) model with factors of age group, site, treatment, and the baseline ISI as a covariate.|ANCOVA|||||-1.25|-4.45|0.0006
70923670|NCT04549168|141339098|SUPERIORITY||LSM difference|-1.74|STANDARD_ERROR_OF_MEAN|0.488||0.0005|TWO_SIDED|95.0|-2.7|-0.78||Based on ANCOVA model with factors of age group, site, treatment, and the baseline ISI as a covariate.|ANCOVA|||||-0.78|-2.70|0.0005
70995735|NCT01804036|141500527|SUPERIORITY_OR_OTHER|||||||0.11|||||||ANCOVA|||||||0.11
70995736|NCT01804036|141500528|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANCOVA|||||||0.95
71100068|NCT02037984|141708867|OTHER|PT9V Percentage Point Difference (V114 - Prevnar 13®)|PT9V Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
71100069|NCT02037984|141708867|OTHER|PT14 Percentage Point Difference (V114 - Prevnar 13®)|PT14 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
71100070|NCT02037984|141708867|OTHER|PT18C Percentage Point Difference (V114 - Prevnar 13®)|PT18C Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
71100071|NCT02037984|141708867|OTHER|PT19A Percentage Point Difference (V114 - Prevnar 13®)|PT19A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
71100072|NCT02037984|141708867|OTHER|PT19F Percentage Point Difference (V114 - Prevnar 13®)|PT19F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
71100073|NCT02037984|141708867|OTHER|PT23F Percentage Point Difference (V114 - Prevnar 13®)|PT23F Percentage Point Difference|-5.9|||||TWO_SIDED|95.0|-19.2|3.9|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||3.9|-19.2|
71100074|NCT02037984|141708867|OTHER|non-PT22F Percentage Point Difference (V114 - Prevnar 13®)|non-PT22F Percentage Point Difference|89.2|||||TWO_SIDED|95.0|75.2|95.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||95.7|75.2|
71100075|NCT02037984|141708867|OTHER|non-PT33F Percentage Point Difference (V114 - Prevnar 13®)|non-PT33F Percentage Point Difference|97.3|||||TWO_SIDED|95.0|85.9|99.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||99.5|85.9|
70995737|NCT01804036|141500529|SUPERIORITY_OR_OTHER|||||||0.08|||||||ANCOVA|||||||0.08
70995738|NCT01804036|141500530|SUPERIORITY_OR_OTHER|||||||0.2|||||||ANCOVA|||||||0.20
70995739|NCT01804036|141500531|SUPERIORITY_OR_OTHER|||||||0.13|||||||ANCOVA|||||||0.13
70995740|NCT01804036|141500532|SUPERIORITY_OR_OTHER|||||||0.52|||||||ANCOVA|||||||0.52
70995741|NCT01804036|141500533|SUPERIORITY_OR_OTHER|||||||0.54|||||||ANCOVA|||||||0.54
70995742|NCT01804036|141500534|SUPERIORITY_OR_OTHER|||||||0.94|||||||ANCOVA|||||||0.94
70995743|NCT01804036|141500535|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANCOVA|||||||0.95
70995744|NCT01804036|141500536|SUPERIORITY_OR_OTHER|||||||0.49|||||||ANCOVA|||||||0.49
70995745|NCT01804036|141500537|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
70995746|NCT01804036|141500538|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
70995747|NCT01804036|141500539|SUPERIORITY_OR_OTHER|||||||0.13|||||||ANCOVA|||||||0.13
70995748|NCT01181102|141500546|NON_INFERIORITY_OR_EQUIVALENCE|"(non-inferiority) When analyzed using the Z test at a one-sided 0.025 significance level, with the addition of a non-inferiority margin of 5% to the incidence in the enoxaparin group.~(superiority) The incidence of thromboembolic events for the FAS was compared using the χ2 test (two-sided significance level: 0.05)"|Cox Proportional Hazard|-6.5|||<|0.001|TWO_SIDED|95.0|-11.5|-1.6||non-inferiority:P \< 0.001 superiority:P = 0.010|non-inferiority:Z test. superiority:χ2 t|||The incidence proportion of thromboembolic events in the DU-176b group (P˅DU) = The incidence proportion of thromboembolic events in the enoxaparin group (P˅E) + Δ (5%). Alternative hypothesis H˅11: P˅DU \< P˅E + Δ (level of significance, 0.025; one-sided). If the null hypothesis H˅01 was rejected, the following analysis had to be sequentially performed using the χ2 test statistic. Null hypothesis H˅02: P˅DU = P˅E Alternative hypothesis H˅12: P˅DU ≠ P˅E (level of significance, 0.05; two-sided).||-1.6|-11.5|<0.001
70995749|NCT01181102|141500547|SUPERIORITY_OR_OTHER||χ2 test|2.5|||||TWO_SIDED|95.0|-0.8|5.9||||||||5.9|-0.8|
70995750|NCT01315002|141500548|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||Null hypothesis is that there was no difference in change of error percentage in the antisaccade task between nicotine and placebo. An ANOVA model was used with treatment (nicotine, placebo) as a within-subjects factor. The test was performed with a significance level of 0.05 (two-sided). Results showed significantly better antisaccade performance (i.e. less antisaccade errors) in the nicotine condition.||||<0.05
70995751|NCT05053126|141500549|SUPERIORITY||Mean Difference (Final Values)|36.83|STANDARD_ERROR_OF_MEAN|3.132|<|0.0001|ONE_SIDED|95.0|31.65||||Mixed Models Analysis|||"The sensitivity and integrity of the study was validated by comparing the mean responses of oxycodone HCl, the positive control (C), to the placebo (P):~H0: μC - μP ≤ δ1 versus Ha: μC - μP \> δ1 where δ1 =15"|||31.65|<0.0001
70995752|NCT05053126|141500549|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|3.49||0.2469|ONE_SIDED|95.0||3.4|||Mixed Models Analysis|||"The primary analysis evaluated whether pregabalin plus oxycodone HCl (T) produced mean responses that showed abuse potential that was no higher than oxycodone HCl (C). The margin for showing no significant difference was defined as 20% of the difference between oxycodone HCl (C) and Placebo (P):~H0: μT - μC ≥ 0.2(μC - μP) versus Ha: μT - μC \<0.2(μC - μP)."||3.4||0.2469
70995753|NCT05053126|141500549|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|3.48||0.1756|ONE_SIDED|95.0||2.5|||Mixed Models Analysis|||"The primary analysis evaluated whether pregabalin plus oxycodone HCl (T) produced mean responses that showed abuse potential that was no higher than oxycodone HCl (C). The margin for showing no significant difference was defined as 20% of the difference between oxycodone HCl (C) and Placebo (P):~H0: μT - μC ≥ 0.2(μC - μP) versus Ha: μT - μC \<0.2(μC - μP)."||2.5||0.1756
70995754|NCT05053126|141500549|NON_INFERIORITY|Non-inferiority margin = 10|Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|2.84||0.0001|ONE_SIDED|95.0||4.3|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether pregabalin (L) produced mean responses that show less abuse potential than oxycodone HCl (C) were:~H0: μC - μL ≤ 0.2 (μC - 50) versus Ha: μC - μL \> 0.2 (μC - 50)"||4.3||0.0001
70995755|NCT05053126|141500549|NON_INFERIORITY|Non-inferiority margin = 10|Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|2.84||0.0099|ONE_SIDED|95.0||8.0|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether pregabalin (L) produced mean responses that show less abuse potential than oxycodone HCl (C) were:~H0: μC - μL ≤ 0.2 (μC - 50) versus Ha: μC - μL \> 0.2 (μC - 50)"||8.0||0.0099
70995756|NCT05053126|141500549|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|18.2|STANDARD_ERROR_OF_MEAN|3.13||0.9888|ONE_SIDED|95.0||23.4|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether pregabalin (L) produced mean responses that show abuse potential similar to placebo(P) were:~H0: μL - μp ≥ δ2 versus Ha: μL - μp \< δ2 where δ2 = 11"||23.4||0.9888
70995757|NCT05053126|141500549|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|22.0|STANDARD_ERROR_OF_MEAN|3.13||0.9997|ONE_SIDED|95.0||27.1|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether pregabalin (L) produced mean responses that show abuse potential similar to placebo(P) were:~H0: μL - μp ≥ δ2 versus Ha: μL - μp \< δ2 where δ2 = 11"||27.1||0.9997
70995758|NCT05053126|141500550|OTHER||Mean Difference (Final Values)|75.6|STANDARD_ERROR_OF_MEAN|5.948|<|0.0001|TWO_SIDED|90.0|65.79|85.42|||Mixed Models Analysis|||||85.42|65.79|<0.0001
70995759|NCT05053126|141500550|OTHER||Mean Difference (Final Values)|44.84|STANDARD_ERROR_OF_MEAN|5.942|<|0.0001|TWO_SIDED|90.0|35.03|54.65|||Mixed Models Analysis|||||54.65|35.03|<0.0001
70995760|NCT05053126|141500550|OTHER||Mean Difference (Final Values)|49.93|STANDARD_ERROR_OF_MEAN|5.945|<|0.0001|TWO_SIDED|90.0|40.12|59.75|||Mixed Models Analysis|||||59.75|40.12|<0.0001
70995761|NCT05053126|141500550|OTHER||Mean Difference (Final Values)|80.8|STANDARD_ERROR_OF_MEAN|5.942|<|0.0001|TWO_SIDED|90.0|70.99|90.61|||Mixed Models Analysis|||||90.61|70.99|<0.0001
70995762|NCT05053126|141500550|OTHER||Mean Difference (Final Values)|81.91|STANDARD_ERROR_OF_MEAN|5.948|<|0.0001|TWO_SIDED|90.0|72.09|91.73|||Mixed Models Analysis|||||91.73|72.09|<0.0001
70995763|NCT05053126|141500550|OTHER||Mean Difference (Final Values)|-30.8|STANDARD_ERROR_OF_MEAN|5.948|<|0.0001|TWO_SIDED|90.0|-40.6|-20.9|||Mixed Models Analysis|||||-20.9|-40.6|<0.0001
70995764|NCT05053126|141500550|OTHER||Mean Difference (Final Values)|-25.7|STANDARD_ERROR_OF_MEAN|5.942|<|0.0001|TWO_SIDED|90.0|-35.5|-15.9|||Mixed Models Analysis|||||-15.9|-35.5|<0.0001
70995765|NCT05053126|141500550|OTHER||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|5.945||0.3829|TWO_SIDED|90.0|-4.62|15.01|||Mixed Models Analysis|||||15.01|-4.62|0.3829
70995766|NCT05053126|141500550|OTHER||Mean Difference (Final Values)|6.31|STANDARD_ERROR_OF_MEAN|5.942||0.2896|TWO_SIDED|90.0|-3.5|16.11|||Mixed Models Analysis|||||16.11|-3.50|0.2896
70995767|NCT05053126|141500551|OTHER||Mean Difference (Final Values)|23.47|STANDARD_ERROR_OF_MEAN|2.247|<|0.0001|TWO_SIDED|90.0|19.77|27.17|||Mixed Models Analysis|||||27.17|19.77|<0.0001
70995768|NCT05053126|141500551|OTHER||Mean Difference (Final Values)|10.4|STANDARD_ERROR_OF_MEAN|2.239|<|0.0001|TWO_SIDED|90.0|6.71|14.09|||Mixed Models Analysis|||||14.09|6.71|<0.0001
70995769|NCT05053126|141500551|OTHER||Mean Difference (Final Values)|11.29|STANDARD_ERROR_OF_MEAN|2.248|<|0.0001|TWO_SIDED|90.0|7.59|14.99|||Mixed Models Analysis|||||14.99|7.59|<0.0001
70995770|NCT05053126|141500551|OTHER||Mean Difference (Final Values)|24.33|STANDARD_ERROR_OF_MEAN|2.251|<|0.0001|TWO_SIDED|90.0|20.62|28.03|||Mixed Models Analysis|||||28.03|20.62|<0.0001
70995771|NCT05053126|141500551|OTHER||Mean Difference (Final Values)|22.34|STANDARD_ERROR_OF_MEAN|2.245|<|0.0001|TWO_SIDED|90.0|18.65|26.04|||Mixed Models Analysis|||||26.04|18.65|<0.0001
70995772|NCT05053126|141500551|OTHER||Mean Difference (Final Values)|-13.1|STANDARD_ERROR_OF_MEAN|2.245|<|0.0001|TWO_SIDED|90.0|-16.8|-9.38|||Mixed Models Analysis|||||-9.38|-16.8|<0.0001
70995773|NCT05053126|141500551|OTHER||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|2.252|<|0.0001|TWO_SIDED|90.0|-15.9|-8.47|||Mixed Models Analysis|||||-8.47|-15.9|<0.0001
70995774|NCT05053126|141500551|OTHER||Mean Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|2.258||0.7051|TWO_SIDED|90.0|-2.86|4.57|||Mixed Models Analysis|||||4.57|-2.86|0.7051
71100076|NCT02037984|141708868|OTHER|PT1 Percentage Point Difference (V114 - Prevnar 13®)|PT1 Percentage Point Difference|-3.4|||||TWO_SIDED|95.0|-17.3|6.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.3|-17.3|
70995775|NCT05053126|141500551|OTHER||Mean Difference (Final Values)|-1.13|STANDARD_ERROR_OF_MEAN|2.246||0.616|TWO_SIDED|90.0|-4.82|2.57|||Mixed Models Analysis|||||2.57|-4.82|0.6160
70995776|NCT05053126|141500552|OTHER||Mean Difference (Final Values)|21.99|STANDARD_ERROR_OF_MEAN|2.235|<|0.0001|TWO_SIDED|90.0|18.31|25.67|||Mixed Models Analysis|||||25.67|18.31|<0.0001
70995777|NCT05053126|141500552|OTHER||Mean Difference (Final Values)|6.4|STANDARD_ERROR_OF_MEAN|2.227||0.0042|TWO_SIDED|90.0|2.73|10.07|||Mixed Models Analysis|||||10.07|2.73|0.0042
70995778|NCT05053126|141500552|OTHER||Mean Difference (Final Values)|9.8|STANDARD_ERROR_OF_MEAN|2.236|<|0.0001|TWO_SIDED|90.0|6.12|13.48|||Mixed Models Analysis|||||13.48|6.12|<0.0001
70995779|NCT05053126|141500552|OTHER||Mean Difference (Final Values)|21.12|STANDARD_ERROR_OF_MEAN|2.239|<|0.0001|TWO_SIDED|90.0|17.44|24.81|||Mixed Models Analysis|||||24.81|17.44|<0.0001
70995780|NCT05053126|141500552|OTHER||Mean Difference (Final Values)|21.27|STANDARD_ERROR_OF_MEAN|2.233|<|0.0001|TWO_SIDED|90.0|17.59|24.95|||Mixed Models Analysis|||||24.95|17.59|<0.0001
70995781|NCT05053126|141500552|OTHER||Mean Difference (Final Values)|-15.6|STANDARD_ERROR_OF_MEAN|2.233|<|0.0001|TWO_SIDED|90.0|-19.3|-11.9|||Mixed Models Analysis|||||-11.9|-19.3|<0.0001
70995782|NCT05053126|141500552|OTHER||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|2.24|<|0.0001|TWO_SIDED|90.0|-15.9|-8.5|||Mixed Models Analysis|||||-8.50|-15.9|<0.0001
70995783|NCT05053126|141500552|OTHER||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|2.246||0.7001|TWO_SIDED|90.0|-4.56|2.83|||Mixed Models Analysis|||||2.83|-4.56|0.7001
70995784|NCT05053126|141500552|OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|2.233||0.7479|TWO_SIDED|90.0|-4.4|2.96|||Mixed Models Analysis|||||2.96|-4.40|0.7479
70995785|NCT05053126|141500553|OTHER||Mean Difference (Final Values)|27.82|STANDARD_ERROR_OF_MEAN|1.439|<|0.0001|TWO_SIDED|90.0|25.45|30.19|||Mixed Models Analysis|||||30.19|25.45|<0.0001
70995786|NCT05053126|141500553|OTHER||Mean Difference (Final Values)|14.53|STANDARD_ERROR_OF_MEAN|1.435|<|0.0001|TWO_SIDED|90.0|12.17|16.89|||Mixed Models Analysis|||||16.89|12.17|<0.0001
70995787|NCT05053126|141500553|OTHER||Mean Difference (Final Values)|17.85|STANDARD_ERROR_OF_MEAN|1.437|<|0.0001|TWO_SIDED|90.0|15.49|20.22|||Mixed Models Analysis|||||20.22|15.49|<0.0001
70995788|NCT05053126|141500553|OTHER||Mean Difference (Final Values)|34.4|STANDARD_ERROR_OF_MEAN|1.438|<|0.0001|TWO_SIDED|90.0|34.4|36.77|||Mixed Models Analysis|||||36.77|34.40|<0.0001
70995789|NCT05053126|141500553|OTHER||Mean Difference (Final Values)|38.84|STANDARD_ERROR_OF_MEAN|1.44|<|0.0001|TWO_SIDED|90.0|36.47|41.21|||Mixed Models Analysis|||||41.21|36.47|<0.0001
70995790|NCT05053126|141500553|OTHER||Mean Difference (Final Values)|-13.3|STANDARD_ERROR_OF_MEAN|1.434|<|0.0001|TWO_SIDED|90.0|-15.6|-10.9|||Mixed Models Analysis|||||-10.9|-15.6|<0.0001
70995791|NCT05053126|141500553|OTHER||Mean Difference (Final Values)|-9.97|STANDARD_ERROR_OF_MEAN|1.435|<|0.0001|TWO_SIDED|90.0|-12.3|-7.61|||Mixed Models Analysis|||||-7.61|-12.3|<0.0001
70995792|NCT05053126|141500553|OTHER||Mean Difference (Final Values)|6.58|STANDARD_ERROR_OF_MEAN|1.436|<|0.0001|TWO_SIDED|90.0|4.22|8.94|||Mixed Models Analysis|||||8.94|4.22|<0.0001
70995793|NCT05053126|141500553|OTHER||Mean Difference (Final Values)|11.02|STANDARD_ERROR_OF_MEAN|1.436|<|0.0001|TWO_SIDED|90.0|8.65|13.38|||Mixed Models Analysis|||||13.38|8.65|<0.0001
70995794|NCT01309841|141500554|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.38||||0.015|TWO_SIDED|95.0|1.062|1.795|||Cochran-Mantel-Haenszel|||Analysis via Cochran Mantel-Haenszel test stratified by response to laxatives at baseline (LIR, LAR, LUR).||1.795|1.062|0.015
70995795|NCT01309841|141500554|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.509||||0.001|TWO_SIDED|95.0|1.168|1.949|||Cochran-Mantel-Haenszel|||Analysis via Cochran Mantel-Haenszel test stratified by response to laxatives at baseline (LIR, LAR, LUR).||1.949|1.168|0.001
70995796|NCT01309841|141500555|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.479||||0.028|TWO_SIDED|95.0|1.038|2.107||Response rate over Weeks 1 to 12 in the LIR subgroup is a key secondary endpoint included in the multiple testing procedure.|Cochran-Mantel-Haenszel|||||2.107|1.038|0.028
71100077|NCT02037984|141708868|OTHER|PT3 Percentage Point Difference (V114 - Prevnar 13®)|PT3 Percentage Point Difference|14.0|||||TWO_SIDED|95.0|-5.5|32.0|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||32.0|-5.5|
71100078|NCT02037984|141708868|OTHER|PT4 Percentage Point Difference (V114 - Prevnar 13®)|PT4 Percentage Point Difference|-7.6|||||TWO_SIDED|95.0|-24.2|5.2|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||5.2|-24.2|
70995797|NCT01309841|141500555|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.691||||0.002|TWO_SIDED|95.0|1.205|2.373||Response rate over Weeks 1 to 12 in the LIR subgroup is a key secondary endpoint included in the multiple testing procedure.|Cochran-Mantel-Haenszel|||||2.373|1.205|0.002
70995798|NCT01309841|141500557|SUPERIORITY_OR_OTHER||LS mean difference|0.55|||<|0.001|TWO_SIDED|95.0|0.24|0.86|||Mixed Models Analysis|||Analysis via Mixed Model Repeated Measures (MMRM) with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.86|0.24|<0.001
70995799|NCT01309841|141500557|SUPERIORITY_OR_OTHER||Ls mean difference|0.82|||<|0.001|TWO_SIDED|95.0|0.51|1.13|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||1.13|0.51|<0.001
70995800|NCT01309841|141500558|SUPERIORITY_OR_OTHER||LS mean difference|-0.09||||0.176|TWO_SIDED|95.0|-0.23|0.04|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.04|-0.23|0.176
70995801|NCT01309841|141500558|SUPERIORITY_OR_OTHER||LS mean difference|-0.18||||0.008|TWO_SIDED|95.0|-0.32|-0.05|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.05|-0.32|0.008
70995802|NCT01309841|141500559|SUPERIORITY_OR_OTHER||LS mean difference|0.05||||0.564|TWO_SIDED|95.0|-0.12|0.23|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.23|-0.12|0.564
70995803|NCT01309841|141500559|SUPERIORITY_OR_OTHER||LS mean difference|0.18||||0.042|TWO_SIDED|95.0|0.01|0.36|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.36|0.01|0.042
70995804|NCT01309841|141500560|SUPERIORITY_OR_OTHER||LS mean difference|3.87||||0.094|TWO_SIDED|95.0|-0.66|8.39|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||8.39|-0.66|0.094
70995805|NCT01309841|141500560|SUPERIORITY_OR_OTHER||LS mean difference|8.59|||<|0.001|TWO_SIDED|95.0|4.04|13.14|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||13.14|4.04|<0.001
71040719|NCT02058160|141590042|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.37|STANDARD_ERROR_OF_MEAN|0.224|<|0.0001|TWO_SIDED|95.0|-1.808|-0.93||Threshold for significance at 0.05 level.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of metformin use at screening, scheduled visits, treatment-by-visit interaction and country as fixed effects and baseline body weight value-by-visit interaction as covariates.||-0.93|-1.808|<0.0001
71040720|NCT02058160|141590043|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.131|<|0.0001|TWO_SIDED|95.0|-1.154|-0.64||Threshold for significance at 0.05 level.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of metformin use at screening, scheduled visits, treatment-by-visit interaction and country as fixed effects and baseline average SMPG value-by-visit interaction as covariates.||-0.64|-1.154|<0.0001
71100079|NCT02037984|141708868|OTHER|PT5 Percentage Point Difference (V114 - Prevnar 13®)|PT5 Percentage Point Difference|-3.4|||||TWO_SIDED|95.0|-17.3|6.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.3|-17.3|
70923671|NCT04549168|141339100|SUPERIORITY||LSM difference|0.34||||0.0312|TWO_SIDED|95.0|0.03|0.65||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM||First 7 mornings of treatment period|||0.65|0.03|0.0312
71100080|NCT02037984|141708868|OTHER|PT6A Percentage Point Difference (V114 - Prevnar 13®)|PT6A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.9|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.9|
70923672|NCT04549168|141339100|SUPERIORITY||LSM difference|0.32||||0.146|TWO_SIDED|95.0|-0.11|0.76||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM||Last 7 mornings of treatment period|||0.76|-0.11|0.1460
70923673|NCT04549168|141339100|SUPERIORITY||LSM difference|0.29||||0.1613|TWO_SIDED|95.0|-0.12|0.7||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM||First 7 mornings of follow-up period|||0.70|-0.12|0.1613
70995806|NCT01309841|141500561|SUPERIORITY_OR_OTHER||LS mean difference|0.54||||0.011|TWO_SIDED|95.0|0.12|0.96|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.96|0.12|0.011
70995807|NCT01309841|141500561|SUPERIORITY_OR_OTHER||LS mean difference|0.99|||<|0.001|TWO_SIDED|95.0|0.57|1.41|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||1.41|0.57|<0.001
71100081|NCT02037984|141708868|OTHER|PT6B Percentage Point Difference (V114 - Prevnar 13®)|PT6B Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.9|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.9|
71100082|NCT02037984|141708868|OTHER|PT7F Percentage Point Difference (V114 - Prevnar 13®)|PT7F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.9|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.9|
71100083|NCT02037984|141708868|OTHER|PT9V Percentage Point Difference (V114 - Prevnar 13®)|PT9V Percentage Point Difference|-3.4|||||TWO_SIDED|95.0|-17.3|6.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.3|-17.3|
70995808|NCT01309841|141500563|SUPERIORITY_OR_OTHER||LS mean difference|-0.08||||0.273|TWO_SIDED|95.0|-0.21|0.06||Analysis for change in PAC-SYM total score from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.06|-0.21|0.273
70995809|NCT01309841|141500563|SUPERIORITY_OR_OTHER||LS mean difference|-0.12||||0.089|TWO_SIDED|95.0|-0.26|0.02||Analysis for change in PAC-SYM total score from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.02|-0.26|0.089
70995810|NCT01309841|141500563|SUPERIORITY_OR_OTHER||Slope|0.02||||0.849|TWO_SIDED|95.0|-0.14|0.17||Analysis for change in PAC-SYM abdominal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.17|-0.14|0.849
70995811|NCT01309841|141500563|SUPERIORITY_OR_OTHER||LS mean difference|-0.03||||0.749|TWO_SIDED|95.0|-0.18|0.13||Analysis for change in PAC-SYM abdominal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.13|-0.18|0.749
70995812|NCT01309841|141500563|SUPERIORITY_OR_OTHER||LS mean difference|-0.13||||0.062|TWO_SIDED|95.0|-0.26|0.01||Analysis for change in PAC-SYM rectal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.01|-0.26|0.062
70995813|NCT01309841|141500563|SUPERIORITY_OR_OTHER||LS mean difference|-0.21||||0.003|TWO_SIDED|95.0|-0.35|-0.07||Analysis for change in PAC-SYM rectal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.07|-0.35|0.003
70995814|NCT01309841|141500563|SUPERIORITY_OR_OTHER||LS mean difference|-0.11||||0.202|TWO_SIDED|95.0|-0.29|0.06||Analysis for change in PAC-SYM stool symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.06|-0.29|0.202
71100084|NCT02037984|141708868|OTHER|PT14 Percentage Point Difference (V114 - Prevnar 13®)|PT14 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.9|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.9|
70995815|NCT01309841|141500563|SUPERIORITY_OR_OTHER||LS mean difference|-0.16||||0.072|TWO_SIDED|95.0|-0.34|0.01||Analysis for change in PAC-SYM stool symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.01|-0.34|0.072
70995816|NCT01309841|141500564|SUPERIORITY_OR_OTHER||LS mean difference|-0.02||||0.831|TWO_SIDED|95.0|-0.25|0.2|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Due to convergence issues, study pooled center is also included as a fixed, rather than random effect.||0.20|-0.25|0.831
70995817|NCT01309841|141500564|SUPERIORITY_OR_OTHER||LS mean difference|-0.18||||0.141|TWO_SIDED|95.0|-0.41|0.06|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Due to convergence issues, study pooled center is also included as a fixed, rather than random effect.||0.06|-0.41|0.141
70995818|NCT03488914|141500566|SUPERIORITY||Slope|-1.09||||0.19|TWO_SIDED|95.0|-2.78|0.56|||negative binomial regression|Model testing whether condition predicted illicit drug use days at 3-months||||.56|-2.78|.19
70995819|NCT03488914|141500566|SUPERIORITY||negative binomial regression|-1.66||||0.12|TWO_SIDED|95.0|-3.78|0.48|||negative binomial regression|Model testing whether condition predicted illicit drug use days at 6-months||||.48|-3.78|.12
70995820|NCT03488914|141500566|SUPERIORITY||Slope|0.01||||0.99|TWO_SIDED|95.0|-2.05|2.07|||negative binomial regression|Model testing whether condition predicted illicit drug use days at 9-months||||2.07|-2.05|.99
70995821|NCT03488914|141500566|SUPERIORITY||Slope|-0.78||||0.42|TWO_SIDED|95.0|-2.67|1.11|||negative binomial regression|Model testing whether condition predicted illicit drug use days at 12-months||||1.11|-2.67|.42
70995822|NCT03488914|141500566|SUPERIORITY||Slope|-1.09||||0.18|TWO_SIDED|95.0|-2.69|0.51|||negative binomial regression|Model testing whether condition predicted illicit drug use days at 15-months||||.51|-2.69|.18
70995823|NCT03488914|141500567|SUPERIORITY||Slope|0.03||||0.96|TWO_SIDED|95.0|-0.86|0.99|||negative binomial regression|Model testing whether condition predicted condomless anal sex acts at 3-months||||.99|-.86|.96
70995824|NCT03488914|141500567|SUPERIORITY||Slope|-1.19||||0.03|TWO_SIDED|95.0|-2.25|-0.14|||negative binomial regression|Model testing whether condition predicted condomless anal sex acts at 6-months||||-.14|-2.25|.03
70995825|NCT03488914|141500567|SUPERIORITY||Slope|0.13||||0.79|TWO_SIDED|95.0|-0.83|1.1|||negative binomial regression|Model testing whether condition predicted condomless anal sex acts at 9-months||||1.10|-.83|.79
70995826|NCT03488914|141500567|SUPERIORITY||Slope|0.06||||0.91|TWO_SIDED|95.0|-0.99|1.11|||negative binomial regression|Model testing whether condition predicted condomless anal sex acts at 12-months||||1.11|-.99|.91
70995827|NCT03488914|141500567|SUPERIORITY||Slope|-0.42||||0.44|TWO_SIDED|95.0|-1.5|0.65|||negative binomial regression|Model testing whether condition predicted condomless anal sex acts at 15-months||||.65|-1.50|.44
71100085|NCT02037984|141708868|OTHER|PT18C Percentage Point Difference (V114 - Prevnar 13®)|PT18C Percentage Point Difference|-3.4|||||TWO_SIDED|95.0|-17.3|6.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.3|-17.3|
70923674|NCT04549168|141339100|SUPERIORITY||LSM difference|0.23||||0.2852|TWO_SIDED|95.0|-0.19|0.65||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM||Last 7 mornings of follow-up period|||0.65|-0.19|0.2852
70995828|NCT03488914|141500568|SUPERIORITY||Slope|-0.26||||0.54|TWO_SIDED|95.0|-1.09|0.58|||negative binomial regression|Model testing whether condition predicted marijuana use days at 3-months||||.58|-1.09|.54
70995829|NCT03488914|141500568|SUPERIORITY||Slope|0.38||||0.49|TWO_SIDED|95.0|-0.7|1.46|||negative binomial regression|Model testing whether condition predicted marijuana use days at 6-months||||1.46|-.70|.49
70995830|NCT03488914|141500568|SUPERIORITY||Slope|-0.26||||0.59|TWO_SIDED|95.0|-1.18|0.66|||negative binomial regression|Model testing whether condition predicted marijuana use days at 9-months||||.66|-1.18|.59
70995831|NCT03488914|141500568|SUPERIORITY||Slope|0.26||||0.65|TWO_SIDED|95.0|-0.86|1.37|||negative binomial regression|Model testing whether condition predicted marijuana use days at 12-months||||1.37|-.86|.65
70995832|NCT03488914|141500568|SUPERIORITY||Slope|-0.36||||0.49|TWO_SIDED|95.0|-1.4|0.67|||negative binomial regression|Model testing whether condition predicted marijuana use days at 15-months||||.67|-1.40|.49
70995833|NCT03488914|141500569|SUPERIORITY||Slope|-0.36||||0.31|TWO_SIDED|995.0|-1.07|0.34|||negative binomial regression|Model testing whether condition predicted alcohol use days at 3-months||||.34|-1.07|.31
70995834|NCT03488914|141500569|SUPERIORITY||Slope|-0.71||||0.1|TWO_SIDED|95.0|-1.57|0.15|||negative binomial regression|Model testing whether condition predicted alcohol use days at 6-months||||.15|-1.57|.10
70995835|NCT03488914|141500569|SUPERIORITY||Slope|-0.53||||0.2|TWO_SIDED|95.0|-1.34|0.28|||negative binomial regression|Model testing whether condition predicted alcohol use days at 9-months||||.28|-1.34|.20
70995836|NCT03488914|141500569|SUPERIORITY||Slope|-0.25||||0.58|TWO_SIDED|95.0|-1.14|0.64|||negative binomial regression|Model testing whether condition predicted alcohol use days at 12-months||||.64|-1.14|.58
70995837|NCT03488914|141500569|SUPERIORITY||Slope|-0.45||||0.34|TWO_SIDED|95.0|-1.37|0.47|||negative binomial regression|Model testing whether condition predicted alcohol use days at 15-months||||.47|-1.37|.34
70995838|NCT01056341|141500632|SUPERIORITY_OR_OTHER||||||<|0.0001||||||"P-value not adjusted for multiplicity. An Independent Committee conducted this analysis to determine the most efficacious of all arms with a good safety profile.~P-value linked to the 3 mg/kg/day 6 months selected arm ."|One-sided Z-tests|One-sided Z-tests for proportions (contrasts tests on placebo) with pooled variance||The interim analysis was carried out after the first 188 patients have completed their W24 visit or been withdrawn prematurely from study therapy. For each propranolol arm, individual hypotheses H0,i: θi≤0||||< 0.0001
70995839|NCT01056341|141500633|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The methodology used guaranteed that the familywise type I error rate was below the nominal one-sided significance level of 0.005.|combination tests|Superiority was tested using the closed testing procedure and combination tests for all intersection hypotheses using Simes' adjustment.||"The objective is to test the superiority of the selected arm using the approach of Posch et al.~The primary analysis was performed on the intent-to-treat population: all treated patients in Stage 1 and all treated patients in stage 2 randomized to placebo or the selected arm."||||< 0.0001
70995840|NCT01714817|141500652|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.08||||0.7264|TWO_SIDED|95.0|0.7077|1.6421|||Stratified logistic regression||Abatacept IV:Placebo IV 95%CI for Odds Ratio|||1.6421|0.7077|0.7264
70995841|NCT01714817|141500653|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.4148|1.5956|||||Abatacept IV:Placebo IV|||1.5956|0.4148|
70995842|NCT01714817|141500654|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|-0.17||||0.571|TWO_SIDED|95.0|-0.76|0.42|||Mixed Models Analysis||Adjusted mean difference from placebo|||0.42|-0.76|0.571
70995843|NCT01714817|141500655|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|-0.09||||0.561|TWO_SIDED|95.0|-0.41|0.22|||Mixed Models Analysis||Adjusted mean difference from placebo|||0.22|-0.41|0.561
70923675|NCT03988634|141339114|SUPERIORITY||Geometric Mean Ratio|0.8546||||0.0492|TWO_SIDED|95.0|0.7307|0.9994|||ANCOVA||Geometric Mean Ratio: sac/val vs valsartan|||0.9994|0.7307|0.0492
70923676|NCT03988634|141339115|SUPERIORITY||Win Ratio|1.193||||0.1578|TWO_SIDED|95.0|0.934|1.524|||unmatched pairwise win-ratio||A win ratio greater than 1 was in favor of sacubitril/valsartan arm|||1.524|0.934|0.1578
70995844|NCT01714817|141500658|SUPERIORITY||Estimate of Difference|1.651|||||TWO_SIDED|95.0|-7.595828|10.897784||||||CR - Day 365||10.897784|-7.595828|
70995845|NCT01714817|141500658|SUPERIORITY||Estimate of Difference|-0.8828|||||TWO_SIDED|95.0|-8.848056|7.082461||||||PR - Day 365||7.082461|-8.848056|
70995846|NCT01714817|141500658|SUPERIORITY||Estimate of Difference|-0.7682|||||TWO_SIDED|95.0|-10.446714|8.910353||||||NR - Day 365||8.910353|-10.446714|
70995847|NCT01714817|141500667|SUPERIORITY|Day 365|Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|0.3251|6.2849||||||||6.2849|0.3251|
70995848|NCT01714817|141500667|SUPERIORITY|Day 729|Estimate of Difference vs Drug|3.4|||||TWO_SIDED|95.0|-8.4|15.1||||||||15.1|-8.4|
70995849|NCT01714817|141500687|SUPERIORITY||Estimate of Difference|-0.9682|||||TWO_SIDED|95.0|-4.760178|2.823876||||||Lupus treatment failure - Day 365||2.823876|-4.760178|
70995850|NCT01714817|141500687|SUPERIORITY||Estimate of Difference|-0.4707|||||TWO_SIDED|95.0|-4.588691|3.647365||||||Overall treatment failure - Day 365||3.647365|-4.588691|
70995851|NCT01714817|141500687|SUPERIORITY|Lupus treatment failure - Day 729|Estimate of Difference|0.8|||||TWO_SIDED|95.0|-4.5|6.1||||||||6.1|-4.5|
70995852|NCT01714817|141500687|SUPERIORITY|Overall treatment failure - Day 729|Estimate of Difference|2.7|||||TWO_SIDED|95.0|-3.3|8.8||||||||8.8|-3.3|
70995853|NCT02921763|141500697|SUPERIORITY||||||=|0.0533|||||||Sign test|||"For the volume calculated from the major and minor axes of ovarian chocolate cyst, the values before treatment initiation and at last observation were compared, frequency of increase and decrease was summarized and the sign test was performed separately in the efficacy analysis set and study completers."||||=0.0533
70995854|NCT02921763|141500699|SUPERIORITY||||||=|0.7328|||||||Wilcoxon (Mann-Whitney)|||"For the volume calculated from the major and minor axes of ovarian chocolate cyst (a total volume if there were two or more cysts), the value, difference from the value before treatment and change rate were calculated using the summary statistics at each measurement point and last observation in each analysis set, namely efficacy analysis set and study completers, and the Wilcoxon signed-rank test was performed for the difference and change rate."||||=0.7328
71100086|NCT02037984|141708868|OTHER|PT19A Percentage Point Difference (V114 - Prevnar 13®)|PT19A Percentage Point Difference|-6.9|||||TWO_SIDED|95.0|-22.1|3.0|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||3.0|-22.1|
70995855|NCT02921763|141500699|SUPERIORITY||||||=|0.1193|||||||Wilcoxon (Mann-Whitney)|||"For the volume calculated from the major and minor axes of ovarian chocolate cyst (a total volume if there were two or more cysts), the value, difference from the value before treatment and change rate were calculated using the summary statistics at each measurement point and last observation in each analysis set, namely efficacy analysis set and study completers, and the Wilcoxon signed-rank test was performed for the difference and change rate."||||=0.1193
70995856|NCT02921763|141500700|SUPERIORITY|||||||0.7221|||||||Wilcoxon (Mann-Whitney)|||"For the volume calculated from the major and minor axes of ovarian chocolate cyst (a total volume if there were two or more cysts), the value, difference from the value before treatment and change rate were calculated using the summary statistics at each measurement point and last observation in each analysis set, namely efficacy analysis set and study completers, and the Wilcoxon signed-rank test was performed for the difference and change rate."||||0.7221
70995857|NCT02921763|141500700|SUPERIORITY|||||||0.0861|||||||Wilcoxon (Mann-Whitney)|||"For the volume calculated from the major and minor axes of ovarian chocolate cyst (a total volume if there were two or more cysts), the value, difference from the value before treatment and change rate were calculated using the summary statistics at each measurement point and last observation in each analysis set, namely efficacy analysis set and study completers, and the Wilcoxon signed-rank test was performed for the difference and change rate."||||0.0861
70995858|NCT02921763|141500704|SUPERIORITY||||||=|0.002|||||||Wilcoxon (Mann-Whitney)|||The score value and difference from the value before treatment were calculated at the same points using the summary statistics, and the Wilcoxon signed-rank test was performed.||||=0.0020
70995859|NCT02921763|141500704|SUPERIORITY||||||=|0.0001|||||||Wilcoxon (Mann-Whitney)|||The score value and difference from the value before treatment were calculated at the same points using the summary statistics, and the Wilcoxon signed-rank test was performed.||||=0.0001
70995860|NCT02921763|141500704|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The score value and difference from the value before treatment were calculated at the same points using the summary statistics, and the Wilcoxon signed-rank test was performed.||||<0.0001
70995861|NCT02921763|141500704|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The score value and difference from the value before treatment were calculated at the same points using the summary statistics, and the Wilcoxon signed-rank test was performed.||||<0.0001
70995862|NCT02921763|141500704|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The score value and difference from the value before treatment were calculated at the same points using the summary statistics, and the Wilcoxon signed-rank test was performed.||||<0.0001
70995863|NCT02921763|141500705|SUPERIORITY||||||=|0.0024|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||=0.0024
70995864|NCT02921763|141500705|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
70995865|NCT02921763|141500705|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
70995866|NCT02921763|141500705|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
70995867|NCT02921763|141500705|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
70995868|NCT02921763|141500706|SUPERIORITY||||||=|0.0037|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||=0.0037
70995869|NCT02921763|141500706|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
70995870|NCT02921763|141500706|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
70995871|NCT02921763|141500706|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
70995872|NCT02921763|141500706|SUPERIORITY||||||=|0.0003|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||=0.0003
70995873|NCT02921763|141500707|SUPERIORITY||||||=|0.8035|||||||Wilcoxon (Mann-Whitney)|||"Separately in the efficacy analysis set and study completers, the values before treatment initiation and at last observation were compared, the value, difference from the value before treatment and change rate were calculated using the summary statistics, and the Wilcoxon signed-rank test was performed for the difference and change rate."||||=0.8035
70995874|NCT02921763|141500708|SUPERIORITY||||||=|0.8185|||||||Wilcoxon (Mann-Whitney)|||"Separately in the efficacy analysis set and study completers, the values before treatment initiation and at last observation were compared, the value, difference from the value before treatment and change rate were calculated using the summary statistics, and the Wilcoxon signed-rank test was performed for the difference and change rate."||||=0.8185
70995875|NCT02007954|141500719|OTHER|||||||0.01||||||P-values \< 0.05 considered statistically significant.|t-test, 2 sided|||Shapiro-Wilk test was run for normality. Baseline and follow-up AFP compared using two-tailed Student's t-test.||||.01
70995876|NCT02659605|141500723|EQUIVALENCE|The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.||||||0.572|||||||Student's t-test|||||||0.572
70995877|NCT02659605|141500724|EQUIVALENCE|The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.||||||0.849|||||||Student's t-test|||||||0.849
70995878|NCT02659605|141500725|EQUIVALENCE|The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.||||||0.886|||||||Student's t-test|||||||0.886
70995879|NCT02659605|141500726|EQUIVALENCE|The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.||||||0.612|||||||Student's t-test|||||||0.612
70995880|NCT02659605|141500727|EQUIVALENCE|The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.||||||0.728|||||||Student's t-test|||||||0.728
70995881|NCT02659605|141500728|EQUIVALENCE|The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.||||||0.584|||||||Student's t-test|||||||0.584
71008538|NCT02140762|141525116|SUPERIORITY_OR_OTHER||Vaccine Effectiveness|20.0|||<|0.0001|TWO_SIDED|95.0|16.0|23.0||VE is based on the relative risk (RR). The POISSON DISTRIBUTION and LOG LINK options was used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects: treatment group, strain (and center).|Generalized Linear Model||VE is based on the relative risk (RR). The POISSON DISTRIBUTION and LOG LINK options was used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects: treatment group, strain (and center).|H0 (Null Hypothesis): Vaccine Effectiveness (VE) ≤10%. If the lower limit of 95% CI for VE is \> 10% the null hypothesis is to be rejected and effectiveness declared. The VE at 4 months after the 2nd injection for each strain is defined as \[1 - (% of subjects without bactericidal activity at 1:8 dilution in MenABCWY group/% of subjects without bactericidal activity at 1:8 dilution in MenACWY group)\] x 100. The combined VE across all strains was computed by mean of a generalized linear model.||23|16|< 0.0001
71008539|NCT02140762|141525116|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|36.4|||||TWO_SIDED|||||||||Vaccine effectiveness\<10% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
71008540|NCT02140762|141525116|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|15.5|||||TWO_SIDED|||||||||Vaccine effectiveness\<30% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
71008541|NCT02140762|141525116|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|20.9|||||TWO_SIDED|||||||||Vaccine effectiveness\<60% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
71008542|NCT02140762|141525116|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|11.8|||||TWO_SIDED|||||||||Vaccine effectiveness\<100% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
71008543|NCT00989664|141525141|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||McNemar|||||||<0.001
71008544|NCT02055976|141525223|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-49.838|STANDARD_ERROR_OF_MEAN|3.775|<|0.001|TWO_SIDED|95.0|-57.335|-42.34|||Mixed Models Analysis|One-sided p-value (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the mixed-effect model for repeated measures (MMRM) model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-42.340|-57.335|<0.001
70995882|NCT02373371|141500799|SUPERIORITY|||||||0.846|||||||Wilcoxon (Mann-Whitney)|||"Main analysis:~* nbDPKAdispM3 the number of KA disappeared at M3 after treatment with DPDT compared to the inclusion layer,~* nbCPKAdispM3 the number of KA disappeared at M3 after treatment with conventional blue light,~The primary endpoint is:~differenceM3 = nbDPKAdispM3 - nbCPKAdispM3 The main analysis will consist of a signed Wilcoxon rank test for matched data testing whether difference M3 is significantly different from 0"||||0.8460
71040721|NCT02058160|141590044|SUPERIORITY_OR_OTHER||difference in percentage|20.82|||<|0.0001|TWO_SIDED|95.0|14.98|26.66||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of metformin use at screening.||26.66|14.98|<0.0001
71040722|NCT02058160|141590045|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.766||0.7362|TWO_SIDED|95.0|-1.762|1.246||Threshold for significance at 0.05 level.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of metformin use at screening, scheduled visits, treatment-by-visit interaction and country as fixed effects and baseline daily insulin glargine dose-by-visit interaction as a covariate.||1.246|-1.762|0.7362
70923677|NCT03988634|141339116|SUPERIORITY||rate ratio|0.8346||||0.3563|TWO_SIDED|95.0|0.5684|1.2255|||LWYY model||A rate ratio \< 1 indicates an effect in favor of LCZ696|||1.2255|0.5684|0.3563
70923678|NCT03988634|141339117|SUPERIORITY||Rate ratio|0.6249||||0.3155|TWO_SIDED|95.0|0.2496|1.5649|||negative binomial regression model|||||1.5649|0.2496|0.3155
70923679|NCT03988634|141339118|SUPERIORITY||ratio of the change|0.9316||||0.4766|TWO_SIDED|95.0|0.7661|1.1329|||ANCOVA|||||1.1329|0.7661|0.4766
70923680|NCT03988634|141339119|SUPERIORITY||ratio of the change|0.8268|||<|0.0001|TWO_SIDED|95.0|0.76|0.91|||ANCOVA|||Week 4||0.91|0.76|<.0001
70923681|NCT03988634|141339119|SUPERIORITY||ratio of the change|0.8103|||<|0.0001|TWO_SIDED|95.0|0.74|0.89|||ANCOVA|||Week 8||0.89|0.74|<.0001
70995883|NCT02373371|141500801|SUPERIORITY|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||||||0.0005
70995884|NCT02373371|141500802|SUPERIORITY|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||||||0.0001
70995885|NCT01293006|141500822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39|||||TWO_SIDED|90.0|-0.12|0.91|||Difference of Least Squares Means|||Difference (Suvorexant - Placebo) of Least Squares Means||0.91|-0.12|
70995886|NCT01293006|141500825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03|||||TWO_SIDED|90.0|-1.3|3.36|||Difference of the Least Means Squares|||Day 1, SaO2 \<90%, Difference (Suvorexant - Placebo) of Least Squares Means||3.36|-1.30|
70995887|NCT01293006|141500825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|||||TWO_SIDED|90.0|-0.08|0.5|||Difference of the Least Squares Means|||Day 1, SaO2 \<85%, Difference (Suvorexant - Placebo) of Least Squares Means||0.50|-0.08|
70995888|NCT01293006|141500825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|||||TWO_SIDED|90.0|-5.77|7.41|||Difference of the Least Squares Means|||Day 4, SaO2 \<90%, Difference (Suvorexant - Placebo) of Least Squares Means||7.41|-5.77|
70995889|NCT01293006|141500825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32|||||TWO_SIDED|90.0|0.0|0.63|||Difference of the Least Squares Means|||Day 4, SaO2 \<85%, Difference (Suvorexant - Placebo) of Least Squares Means||0.63|0.00|
70995890|NCT01293006|141500826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72|||||TWO_SIDED|90.0|-0.6|2.04|||Difference of the Least Squares Means|||Day 1, Difference (Suvorexant - Placebo) of Least Squares Means||2.04|-0.60|
70995891|NCT01293006|141500826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.05|||||TWO_SIDED|90.0|0.33|3.77|||Difference of the Least Squares Means|||Day 4, Difference (Suvorexant - Placebo) of Least Squares Means||3.77|0.33|
70995892|NCT01293006|141500827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|||||TWO_SIDED|90.0|-0.41|0.47|||Difference in the Least Squares Means|||Day 1, REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.47|-0.41|
70995893|NCT01293006|141500827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|||||TWO_SIDED|90.0|-0.53|0.27|||Difference of the Least Squares Means|||Day 1, Non-REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.27|-0.53|
70995894|NCT01293006|141500827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|||||TWO_SIDED|90.0|-0.61|0.18|||Difference of the Least Squares Means|||Day 1, Wake, Difference (Suvorexant - Placebo) of Least Squares Means||0.18|-0.61|
70995895|NCT01293006|141500827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||||TWO_SIDED|90.0|-0.32|0.98|||Difference of the Least Squares Means|||Day 4, REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.98|-0.32|
70995896|NCT01293006|141500827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|||||TWO_SIDED|90.0|-0.26|0.78|||Difference of the Least Squares Means|||Day 4, Non-REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.78|-0.26|
70995897|NCT01293006|141500827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|||||TWO_SIDED|90.0|0.1|0.8|||Difference of the Least Squares Means|||Day 4, Wake, Difference (Suvorexant - Placebo) of Least Squares Means||0.80|0.10|
70995898|NCT01293006|141500828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|90.0|-0.5|0.31|||Difference in the Least Squares Means|||Difference (Suvorexant - Placebo) of Least Squares Means||0.31|-0.50|
70995899|NCT00873288|141500840|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||t-test, 2 sided|||||||> 0.05
70995900|NCT00873288|141500842|SUPERIORITY|||||||0.207|||||||Chi-squared|The Pearson Chi-squared value = 1.590||||||0.207
70995901|NCT00873288|141500843|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|||||||t-test, 2 sided|||||||0.66
70995902|NCT04131933|141500892|SUPERIORITY|It was hypothesized that there would be a 50% reduction in Oncotype DX assay requests following the intervention.||||||0.37|||||||Fisher Exact|Fisher's exact test to compare number of patients with Oncotype DX ordered at 0-6 months (pre-intervention) vs 7-12 months (post-intervention)||Pre-Intervention (Period 1 and Period 2) vs Post-Intervention (Period 3 and Period 4)||||0.37
71040723|NCT03538262|141590121|OTHER|||||||0.006|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.006
71040724|NCT03538262|141590121|OTHER|Statistical analysis for BL to Month 24|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70923682|NCT04725240|141339122|OTHER||||||<|0.0001||||||Threshold for significance at 0.001 level.|One-sided exact binomial test|||||||<0.0001
70923683|NCT04725240|141339123|OTHER||||||<|0.0001||||||Threshold for significance at 0.001 level.|One-sided exact binomial test|||||||<0.0001
70923684|NCT04725240|141339124|OTHER||||||<|0.0001||||||Threshold for significance at 0.001 level.|One-sided exact binomial test|||||||<0.0001
70923685|NCT04725240|141339125|OTHER||||||<|0.0001||||||Threshold for significance at 0.001 level.|One-sided exact binomial test|||||||<0.0001
70923686|NCT02867384|141339139|SUPERIORITY|||||||0.0008|||||||Fisher Exact|||||||0.0008
70923687|NCT01351805|141339152|OTHER|Test of change from baseline as above.|Percent change in geometric means|8.19||||0.02|TWO_SIDED|95.0|1.52|15.31||IL-6 from baseline to one year: overall % change= 8.19% (95%CI 1.52-15.31).|as above|p above adjusted for age, sex, race and n-3 fatty acid randomized treatment group.||Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.||15.31|1.52|0.02
70923688|NCT01351805|141339152|OTHER|Test of change from baseline as above.|Percent change in geometric means|-0.73||||0.97|TWO_SIDED|95.0|-6.87|5.81||4\. IL-6 from baseline to one year: overall % change= -0.73% (95%CI -6.87 to 5.81).|as above|p above adjusted for age, sex, race and vitamin D randomized treatment group.||Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.||5.81|-6.87|0.97
70923689|NCT01351805|141339152|SUPERIORITY|Multiplicative interaction between strata based on linear models of ln biomarker from baseline to year 1,p for interaction between strata.||||||0.12||||||Test of multiplicative interaction between the effects of the two supplements|p for interaction|||Test for interaction between effect of vitamin D and effect of omega-3 fatty acids on IL-6 change from baseline to 1 year||||0.12
70923690|NCT01351805|141339153|OTHER|Test of change from baseline as above.|Percent change in geometric means|7.12||||0.16|TWO_SIDED|95.0|-1.81|16.87||3\. HsCRP from baseline to one year: overall % change= 7.12% (95%CI -1.81-16.78).|as above|p above adjusted for age, sex, race and n-3 fatty acid randomized treatment group.||Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.||16.87|-1.81|0.16
70995903|NCT00698035|141500908|SUPERIORITY_OR_OTHER||||||>|0.05||||||Significant at p\<0.05|t-test, 2 sided|||Comparison of baseline estradiol between LC/MS and RIA||||>0.05
70995904|NCT00698035|141500908|SUPERIORITY_OR_OTHER||||||>|0.05||||||singificant at p\<0.05|t-test, 2 sided|||Comparison of week 4 estradiol between LC/MS and RIA||||>0.05
70995905|NCT00698035|141500911|SUPERIORITY_OR_OTHER|||||||0.021||||||Significant at p\<0.05|t-test, 2 sided|||Change in SI from BL to W12||||0.021
70923691|NCT01351805|141339153|OTHER|Test of change from baseline as above.|Percent change in geometric means|-3.89||||0.44|TWO_SIDED|95.0|-11.92|4.86||6\. HsCRP from baseline to one year: overall % change= -3.89% (95%CI -11.92-4.86).|as above|p above adjusted for age, sex, race and vitamin D randomized treatment group.||Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.||4.86|-11.92|0.44
70923692|NCT01351805|141339153|SUPERIORITY|||||||0.38|||||||P for interaction|||Test for multiplicative interaction between effect of vitamin D and effect of omega-3. based on linear models of ln biomarker from baseline to year 1.||||0.38
70923693|NCT01351805|141339154|OTHER|Test of change from baseline as above.|Percent change in geometric means|0.63||||0.57|TWO_SIDED|95.0|-1.03|2.31||2\. TNFR2 from baseline to one year: overall % change= 0.63% (95%CI -1.03 to 2.31).|as above|p above adjusted for age, sex, race and n-3 fatty acid randomized treatment group.||Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.||2.31|-1.03|0.57
70923694|NCT01351805|141339154|OTHER|Test of change from baseline as above.|Percent change in geometric means|-1.27||||0.13|TWO_SIDED|95.0|-2.89|0.39||5\. TNFR2 from baseline to one year: overall % change= -1.27% (95%CI -2.89 to 0.39).|as above|p above adjusted for age, sex, race and vitamin D randomized treatment group.||Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.||0.39|-2.89|0.13
70923695|NCT01351805|141339154|SUPERIORITY|Multiplicative interaction between strata based on linear models of ln biomarker from baseline to year 1 with p for interaction between strata.||||||0.74|||||||P for interaction|||Test for multiplicative interaction between effect of vitamin D and effect of omega-3. based on linear models of ln biomarker from baseline to year 1.||||0.74
70923696|NCT01351805|141339155|OTHER||Cox Proportional Hazard|0.78||||0.05|TWO_SIDED|95.0|0.61|0.99|||Regression, Cox|||||0.99|0.61|0.05
70923697|NCT01351805|141339155|SUPERIORITY||Cox Proportional Hazard|0.85||||0.19|TWO_SIDED|95.0|0.67|1.08|||Regression, Cox|||||1.08|0.67|0.19
70995906|NCT00698035|141500911|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significant at p\<0.05|t-test, 2 sided|||Change in SD from BL to W12||||<0.001
70995907|NCT00698035|141500911|SUPERIORITY_OR_OTHER|||||||0.0228||||||Significant at p\<0.05|t-test, 2 sided|||Change in SI from BL to W12||||0.0228
70995908|NCT00698035|141500911|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significant at p\<0.05|t-test, 2 sided|||Change in SD from BL to W12||||<0.001
70995909|NCT00698035|141500912|SUPERIORITY_OR_OTHER|||||||0.004||||||Significant at p\<0.05|t-test, 2 sided|||Change in SS from Baseline to Week 12||||0.004
70995910|NCT00698035|141500912|SUPERIORITY_OR_OTHER|||||||0.139||||||Significant at p\<0.05|t-test, 2 sided|||Change in SS from Baseline to Week 12||||0.139
70995911|NCT00698035|141500913|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significant at p\<0.05|t-test, 2 sided|||Differences in rugae, pallor, petechiae, mucosal thinning and dryness between baseline and week 12||||<0.001
70995912|NCT00698035|141500913|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significant at p\<0.05|t-test, 2 sided|||Differences in rugae, pallor, mucosal thinning, and dryness from baseline to 12 weeks||||<0.001
70995913|NCT00698035|141500913|SUPERIORITY_OR_OTHER|||||||0.0061||||||Significant at p\<0.05|t-test, 2 sided|||Difference in petechiae between baseline and week 12||||0.0061
70995914|NCT03783442|141500914|SUPERIORITY||Stratified Hazard Ratio|0.66|||<|0.0001|TWO_SIDED|95.0|0.54|0.8|||Stratified Log-rank Test|One-sided p-value estimated from log rank test stratified by pooled geographic region, prior definitive therapy and Investigator chemotherapy choice|Stratified Hazard ratio was based on Cox regression model including treatment arm as a covariate and stratified by pooled geographic region (Asia vs. Rest of World), prior definitive therapy and Investigator choice of chemotherapy as strata.|||0.80|0.54|<0.0001
70995915|NCT03783442|141500915|SUPERIORITY||Stratified Hazard Ratio|0.62|||<|0.0001|TWO_SIDED|95.0|0.52|0.75|||Stratified Log-rank test|One-sided p-value estimated from log rank test stratified by pooled geographic region, prior definitive therapy and Investigator chemotherapy choice.|Stratified Hazard ratio was based on Cox regression model including treatment arm as a covariate and stratified by pooled geographic region (Asia vs. Rest of World), prior definitive therapy and Investigator choice of chemotherapy as strata.|||0.75|0.52|<0.0001
71040725|NCT03538262|141590122|OTHER|||||||0.011|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.011
71040726|NCT03538262|141590122|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||<0.001
71040727|NCT03538262|141590123|OTHER|||||||0.007|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 3||||0.007
71040728|NCT03538262|141590123|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 6||||<0.001
71100087|NCT02037984|141708868|OTHER|PT19F Percentage Point Difference (V114 - Prevnar 13®)|PT19F Percentage Point Difference|-3.4|||||TWO_SIDED|95.0|-17.3|6.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.3|-17.3|
71100088|NCT02037984|141708868|OTHER|PT23F Percentage Point Difference (V114 - Prevnar 13®)|PT23F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.9|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.9|
70995916|NCT03783442|141500916|SUPERIORITY||Odds Ratio (OR)|2.38|||<|0.0001|TWO_SIDED|95.0|1.73|3.27|||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test was stratified by pooled geographic region, prior definitive therapy, and Investigator choice of chemotherapy.|Odds ratio was calculated using the Cochran-Mantel-Haenszel method, stratified by pooled geographic region, prior definitive therapy, and Investigator choice of chemotherapy.|||3.27|1.73|<0.0001
70995917|NCT03783442|141500917|SUPERIORITY||Stratified Hazard Ratio|0.62||||0.0029|TWO_SIDED|95.0|0.44|0.87|||Stratified Log-rank test|One-sided p-value estimated from log rank test stratified by pooled geographic region, prior definitive therapy and Investigator chemotherapy choice.|Stratified Hazard ratio was based on Cox regression model including treatment arm as a covariate and stratified by pooled geographic region (Asia vs. Rest of World), prior definitive therapy and Investigator choice of chemotherapy as strata.|||0.87|0.44|0.0029
71040729|NCT03538262|141590123|OTHER|||||||0.004|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 9||||0.004
71040730|NCT03538262|141590123|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||<0.001
71040731|NCT03538262|141590123|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 15||||<0.001
71040732|NCT03538262|141590123|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 18||||<0.001
71040733|NCT03538262|141590123|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 21||||<0.001
71040734|NCT03538262|141590123|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||<0.001
71040735|NCT03538262|141590124|OTHER|||||||0.996|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 6||||0.996
71040736|NCT03538262|141590124|OTHER|||||||0.054|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.054
71040737|NCT03538262|141590124|OTHER|||||||0.025|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 18||||0.025
71040738|NCT03538262|141590124|OTHER|||||||0.006|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||0.006
71040739|NCT03538262|141590125|OTHER|||||||0.145|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.145
71040740|NCT03538262|141590125|OTHER|||||||0.029|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||0.029
71040741|NCT03538262|141590126|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||<.001
71040742|NCT03538262|141590126|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||<0.001
71040743|NCT03538262|141590127|OTHER|||||||0.382|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.382
71040744|NCT03538262|141590127|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||<0.001
71040745|NCT03538262|141590128|OTHER|||||||0.688|||||||Mixed Models Analysis|||Secondary analysis for BL to Month 12||||0.688
71040746|NCT03538262|141590128|OTHER|||||||0.293|||||||Mixed Models Analysis|||Secondary analysis for BL to Month 24||||0.293
71040747|NCT03538262|141590129|OTHER|||||||0.446|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.446
71040748|NCT03538262|141590129|OTHER|||||||0.565|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||0.565
71040749|NCT03538262|141590130|OTHER|||||||0.006|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.006
71100089|NCT02037984|141708868|OTHER|non-PT22F Percentage Point Difference (V114 - Prevnar 13®)|non-PT22F Percentage Point Difference|89.2|||||TWO_SIDED|95.0|75.2|95.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||95.7|75.2|
70923698|NCT01351805|141339155|SUPERIORITY|||||||0.2|||||||P for interaction|p multiplicative interaction between effects of vitamin D and n-3 fa supplements||Test for multiplicative interaction between the effects of randomized treatment groups, vitamin D and n-3 fa on incidence of autoimmune disease.||||0.20
70995918|NCT03783442|141500919|SUPERIORITY||Least Squares (LS) Mean Difference|4.4||||0.1372|TWO_SIDED|95.0|-1.4|10.3|||Mixed Models Analysis|Two-sided p-value estimated from a mixed effect model|Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in EORTC QLQ-OES18 Dysphagia Score at Cycle 6||10.3|-1.4|0.1372
70995919|NCT03783442|141500919|SUPERIORITY||LS Mean Difference|0.6||||0.713|TWO_SIDED|95.0|-2.5|3.7|||Mixed Models Analysis|Two-sided p-value estimated from a mixed effect model|Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in EORTC QLQ-OES18 Eating Score at Cycle 6||3.7|-2.5|0.7130
70995920|NCT03783442|141500919|SUPERIORITY||LS Mean Difference|-1.4||||0.3001|TWO_SIDED|95.0|-4.1|1.3|||Mixed Models Analysis|Two-sided p-value estimated from a mixed effect model|Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in EORTC QLQ-OES18 Reflux Score at Cycle 6||1.3|-4.1|0.3001
70995921|NCT03783442|141500919|OTHER||LS Mean Difference|-1.9|||||TWO_SIDED|95.0|-3.9|0.2|||||Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in EORTC QLQ-OES18 Pain Score at Cycle 6||0.2|-3.9|
70995922|NCT03783442|141500919|OTHER||LS Mean Difference|-0.4|||||TWO_SIDED|95.0|-2.1|1.4|||||Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in EORTC QLQ-OES18 Index Score at Cycle 6||1.4|-2.1|
70995923|NCT03783442|141500920|OTHER||LS Mean Difference|3.3|||||TWO_SIDED|95.0|0.4|6.2|||||Based on a mixed effect model analysis, with QLQ-C30 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in Global Health Status/QoL at Cycle 6||6.2|0.4|
70995924|NCT03783442|141500920|OTHER||LS Mean Difference|2.6|||||TWO_SIDED|95.0|0.0|5.1|||||Based on a mixed effect model analysis, with QLQ-C30 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in Physical Functioning at Cycle 6||5.1|0.0|
71100090|NCT02037984|141708868|OTHER|non-PT33F Percentage Point Difference (V114 - Prevnar 13®)|non-PT33F Percentage Point Difference|93.8|||||TWO_SIDED|95.0|78.5|98.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||98.3|78.5|
70923699|NCT01351805|141339156|OTHER|We assessed the main effects of the treatment arms comparing all those randomized to omega-3 fatty acids or omega-3 fatty acid placebo, regardless of vitamin D randomization status.||||||0.77||||||Repeated measures model with unstructured variance to assess effect of treatment on WOMAC Pain adjusting for age, sex, and other treatment. Linear time by treatment interaction term assessed change in WOMAC Pain over time in treatment vs placebo.|Mixed Models Analysis|Repeated measures model with censoring for total knee replacement.||Intention to treat analysis using a repeated measures model with unstructured variance to assess the effect of treatment arm on WOMAC Pain adjusting for age, sex, and the other treatment arm. The linear time by treatment interaction term assessed change in WOMAC Pain over time between participants randomized to treatment versus placebo.||||0.77
70995925|NCT03783442|141500921|OTHER||LS Mean Difference|-1.4|||||TWO_SIDED|95.0|-4.7|1.9|||||Based on a mixed effect model analysis with QLQ-C30 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|||1.9|-4.7|
70995926|NCT03483116|141500928|NON_INFERIORITY|Non-inferiority of the lower titre vaccine was demonstrated if the upper bound of the CI was below 20%.|Response rate|0.1553|||||TWO_SIDED|95.0|0.039|0.272||||||||0.272|0.039|
70995927|NCT03483116|141500928|NON_INFERIORITY|Non-inferiority of the lower titre vaccine was demonstrated if the upper bound of the CI was below 20%|Response rate|0.001|||||TWO_SIDED|95.0|-0.115|0.117||||||||0.117|-0.115|
70995928|NCT03483116|141500928|NON_INFERIORITY|Non-inferiority of the lower titre vaccine was demonstrated if the upper bound of the CI was below 20%|Difference Response rate|0.1543|||||TWO_SIDED|95.0|0.038|0.27||||||Non-inferiority of the lower titre vaccine was demonstrated if the upper bound of the CI was below 20%||0.270|0.038|
70995929|NCT02703987|141500938|SUPERIORITY||Mean Difference (Net)|0.32|STANDARD_ERROR_OF_MEAN|0.17||0.0801|TWO_SIDED|95.0|-0.04|0.67|||Mixed Models Analysis|||||0.67|-0.04|0.0801
70995930|NCT02703987|141500939|SUPERIORITY||Mean Difference (Net)|0.34|STANDARD_ERROR_OF_MEAN|0.18||0.0714|TWO_SIDED|95.0|-0.03|0.71|||Mixed Models Analysis|||||0.71|-0.03|0.0714
70995931|NCT02703987|141500940|SUPERIORITY||Mean Difference (Net)|9.56|STANDARD_ERROR_OF_MEAN|4.85||0.0609|TWO_SIDED|95.0|-0.48|19.6|||Mixed Models Analysis|||||19.6|-0.48|0.0609
70995932|NCT01583452|141500957|SUPERIORITY_OR_OTHER|||||||0.665|TWO_SIDED||||||Kaplan-Meier survival analysis|||With a confidence interval of 95%, an alpha risk of 5% and a desired power of 80%; expecting a 24hrs difference between the intervention and the control group, we estimated 20 patients for each one of them.||||0.665
70995933|NCT01583452|141500958|SUPERIORITY_OR_OTHER|||||||0.094|TWO_SIDED||||||Kaplan-Meier survival analysis|||||||0.094
70995934|NCT01583452|141500959|SUPERIORITY_OR_OTHER|||||||0.059|TWO_SIDED||||||Kaplan-Meier survival analysis|||||||0.059
70995935|NCT01583452|141500960|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Kaplan-Meier survival analysis|||||||0.830
70995936|NCT03103906|141500973|OTHER||Difference in proportion|2.56||||0.3334|TWO_SIDED|95.0|-19.99|25.07|||Chi-squared|||||25.07|-19.99|0.3334
70995937|NCT03571256|141500981|OTHER||LS mean difference|-0.8||||0.6|TWO_SIDED|95.0|-3.9|2.3||Threshold for significance at 0.05 level.|Mixed Models Analysis|||||2.3|-3.9|0.600
70995938|NCT00868452|141500992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6|STANDARD_ERROR_OF_MEAN|1.25||0.005|||||||Mixed Models Analysis|||||||0.005
70995939|NCT00868452|141500993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.15||0.003|||||||Mixed Models Analysis|||||||0.003
70995940|NCT00868452|141500994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6|STANDARD_ERROR_OF_MEAN|1.01||0.012|||||||ANCOVA|||||||0.012
70995941|NCT00643604|141501019|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69||0.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.69
70995942|NCT00643604|141501020|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
70995943|NCT00643604|141501021|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.13
70995944|NCT00643604|141501022|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0||||p value for Symptom Score|Wilcoxon signed rank test|||Changes in mean CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.03
70995945|NCT00643604|141501022|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0||||p value for Activity Score.|Wilcoxon signed rank test|||Activity Score N=5; Baseline component score could not be calculated for one subject. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
70995946|NCT00643604|141501022|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||95.0|||||Wilcoxon signed-rank test|||Quality of Life Score. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.31
70995947|NCT00643604|141501022|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13||95.0|||||Wilcoxon signed-rank test|||"Total Score N=5; Baseline Activity component score could not be calculated for one subject. Total Score could not be calculated for this subject.~Wilcoxon signed rank test was used to compare the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values."||||0.13
70995948|NCT00643604|141501023|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19||95.0|||||Wilcoxon signed-rank test|||Effectiveness Score Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.19
71040750|NCT03538262|141590130|OTHER|||||||0.937|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||0.937
71040751|NCT03538262|141590131|OTHER|||||||0.041|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 3||||0.041
71040752|NCT03538262|141590131|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 6||||<0.001
71040753|NCT03538262|141590131|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 9||||<0.001
71040754|NCT03538262|141590131|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||<0.001
71040755|NCT03538262|141590131|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 15||||<0.001
71040756|NCT03538262|141590131|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 18||||<0.001
71040757|NCT03538262|141590131|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 21||||<0.001
71040758|NCT03538262|141590131|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||<0.001
71040759|NCT03538262|141590132|OTHER|||||||0.595|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 6||||0.595
71040760|NCT03538262|141590132|OTHER|||||||0.44|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.440
71040761|NCT03538262|141590132|OTHER|||||||0.909|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 18||||0.909
71040762|NCT03538262|141590132|OTHER|||||||0.068|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||0.068
71040763|NCT03538262|141590133|OTHER|||||||0.074|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 3||||0.074
71040764|NCT03538262|141590133|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 6||||<0.001
71040765|NCT03538262|141590133|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 9||||<0.001
71040766|NCT03538262|141590133|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||<0.001
71040767|NCT03538262|141590133|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 15||||<0.001
71040768|NCT03538262|141590133|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 18||||<0.001
71040769|NCT03538262|141590133|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 21||||<0.001
71040770|NCT03538262|141590133|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||<0.001
70995949|NCT00643604|141501023|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19||95.0|||||Wilcoxon signed-rank test|||Side-Effects Score. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.19
70995950|NCT00643604|141501023|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0|||||Wilcoxon signed-rank test|||Convenience Score. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.03
70995951|NCT00643604|141501023|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88||95.0|||||Wilcoxon signed-rank test|||Global Satisfaction Score. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.88
70995952|NCT00643604|141501024|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25||95.0|||||Wilcoxon signed-rank test|||Gather/Set-up. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.25
70995953|NCT00643604|141501024|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06||95.0|||||Wilcoxon signed-rank test|||Prepare Drug. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.06
70995954|NCT00643604|141501024|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63||95.0|||||Wilcoxon signed-rank test|||Connect Drug. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.63
70995955|NCT00643604|141501024|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88||95.0|||||Wilcoxon signed-rank test|||Change Dressing. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.88
70995956|NCT00643604|141501024|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13||95.0|||||Wilcoxon signed-rank test|||Total Time. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.13
70995957|NCT00643604|141501025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.5
70995958|NCT00643604|141501026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25||95.0|||||Wilcoxon sign-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.25
70995959|NCT00643604|141501027|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
70995960|NCT00643604|141501028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.50
70995961|NCT00643604|141501029|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
71040771|NCT03538262|141590134|OTHER|||||||0.2|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 3||||0.200
71040772|NCT03538262|141590134|OTHER|||||||0.888|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 6||||0.888
70995962|NCT00643604|141501030|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
70995963|NCT00643604|141501031|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
70995964|NCT02702011|141501040|SUPERIORITY_OR_OTHER||Mean Difference (Net)|65.1|STANDARD_ERROR_OF_MEAN|10.81|<|0.0001|TWO_SIDED|95.0|43.29|86.9|||ANCOVA||Mean Difference was calculated as: (mean change from baseline in 24 hour UGE at Day 7 in Empagliflozin 2.5 mg group) - (mean change from baseline in 24 hour UGE at Day 7 in Placebo group)|An analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline as a linear covariate was fitted to the change from baseline of 24 hour UGE (g/24h) on Day 7, where baseline refers to the last observation prior to the first intake of any randomised trial medication.||86.90|43.29|<0.0001
70995965|NCT02702011|141501040|SUPERIORITY_OR_OTHER||Mean Difference (Net)|81.19|STANDARD_ERROR_OF_MEAN|11.1|<|0.0001|TWO_SIDED|95.0|58.8|103.58|||ANCOVA||Mean Difference was calculated as: (mean change from baseline in 24 hour UGE at Day 7 in Empagliflozin 10 mg group) - (mean change from baseline in 24 hour UGE at Day 7 in Placebo group)|An analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline as a linear covariate was fitted to the change from baseline of 24 hour UGE (g/24h) on Day 7, where baseline refers to the last observation prior to the first intake of any randomised trial medication.||103.58|58.80|<0.0001
70995966|NCT02702011|141501040|SUPERIORITY_OR_OTHER||Mean Difference (Net)|98.11|STANDARD_ERROR_OF_MEAN|11.01|<|0.0001|TWO_SIDED|95.0|75.91|120.31|||ANCOVA||Mean Difference was calculated as: (mean change from baseline in 24 hour UGE at Day 7 in Empagliflozin 25 mg group) - (mean change from baseline in 24 hour UGE at Day 7 in Placebo group)|An analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline as a linear covariate was fitted to the change from baseline of 24 hour UGE (g/24h) on Day 7, where baseline refers to the last observation prior to the first intake of any randomised trial medication.||120.31|75.91|<0.0001
70995967|NCT01369212|141501053|SUPERIORITY|||||||0.72|||||||Wald test|Proportion with HBsAg loss at week 240 in each group is estimated by Kaplan-Meier and then equality of proportion is tested using Wald test.||||||0.72
71100091|NCT03211858|141708888|NON_INFERIORITY|Non-inferiority of SAR341402 over NovoLog/NovoRapid was demonstrated if upper bound of the 2-sided 95% confidence interval (CI) of the difference between SAR341402 and NovoLog/NovoRapid was \<0.3%. If non-inferiority was demonstrated, using a hierarchical step down testing procedure, the inverse non-inferiority of NovoLog/NovoRapid over SAR341402 was tested and was demonstrated if lower bound of the 2-sided 95% CI of the difference between SAR341402 and NovoLog/NovoRapid was \> -0.3%.|LS Mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.059|||TWO_SIDED|95.0|-0.192|0.039|||||SAR341402 vs NovoLog/NovoRapid|Analysis was performed using ANCOVA with treatment group (SAR341402, NovoLog/NovoRapid), the randomization strata of geographical region, type of diabetes and prior use of NovoLog/NovoRapid as fixed categorical effects, as well as the continuous fixed covariate of baseline HbA1c value.||0.039|-0.192|
71100092|NCT01866150|141708906|SUPERIORITY_OR_OTHER||Treatment Difference|1.2||||0.8222|TWO_SIDED|95.0|-9.5|12.0|||Pearson's chi-squared|||A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved DAS28 remission.||12.0|-9.5|0.8222
71100093|NCT01866150|141708907|SUPERIORITY_OR_OTHER||Treatment Difference|3.7||||0.4727|TWO_SIDED|95.0|-6.2|13.6|||Pearson's chi-squared|||Comparison at Month 3. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved DAS28 remission.||13.6|-6.2|0.4727
71100094|NCT01866150|141708907|SUPERIORITY_OR_OTHER||Treatment Difference|2.6||||0.6349|TWO_SIDED|95.0|-8.0|13.1|||Pearson's chi-squared|||Comparison at last visit. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved DAS28 remission.||13.1|-8.0|0.6349
71100095|NCT01866150|141708908|SUPERIORITY_OR_OTHER||Slope|-0.9||||0.8769|TWO_SIDED|95.0|-12.1|10.4|||Pearson's chi-squared|||Comparison at Month 3. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved LDA.||10.4|-12.1|0.8769
70995968|NCT01369212|141501054|SUPERIORITY|||||||0.09||||||The cumulative percentages with HBsAg loss at week 192 were estimated using Kaplan-Meier method and then the equality is tested using Wald test.|Wald Test|||||||0.09
70995969|NCT01369212|141501055|SUPERIORITY|||||||0.46|||||||Fisher Exact|||||||0.46
71100096|NCT01866150|141708908|SUPERIORITY_OR_OTHER||Treatment Difference|3.4||||0.5649|TWO_SIDED|95.0|-8.2|15.0|||Pearson's chi-squared|||Comparison at Month 6. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved LDA.||15.0|-8.2|0.5649
71100097|NCT01866150|141708908|SUPERIORITY_OR_OTHER||Treatment Difference|9.9||||0.0556|TWO_SIDED|95.0|-0.3|20.2|||Pearson's chi-squared|||Comparison at the last visit. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved LDA.||20.2|-0.3|0.0556
71100098|NCT01866150|141708909|SUPERIORITY_OR_OTHER||Treatment Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.152||0.5195|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|||Comparison at Month 3. Analysis used a mixed model with month, cohort, baseline DAS28 score; cohort-by-month and cohort-by-baseline DAS28 score as fixed effects. Within-participant repeated measurements were incorporated with an unstructured variance-covariance structure.||0.20|-0.40|0.5195
71100099|NCT01866150|141708909|SUPERIORITY_OR_OTHER||Treatment difference|-0.17|STANDARD_ERROR_OF_MEAN|0.149||0.242|TWO_SIDED|95.0|-0.47|0.12|||Mixed Models Analysis|||Comparison at Month 6. Analysis used a mixed model with month, cohort, baseline DAS28 score; cohort-by-month and cohort-by-baseline DAS28 score as fixed effects. Within-participant repeated measurements were incorporated with an unstructured variance-covariance structure.||0.12|-0.47|0.2420
70995970|NCT01369212|141501056|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
70995971|NCT01369212|141501057|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
70995972|NCT01369212|141501058|SUPERIORITY|||||||0.039|||||||Fisher Exact|||||||0.039
70995973|NCT01369212|141501059|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.20
70995974|NCT01369212|141501060|SUPERIORITY|||||||0.44|||||||Fisher Exact|||||||0.44
70995975|NCT01369212|141501061|SUPERIORITY|||||||0.06|||||||Fisher Exact|||||||0.06
70995976|NCT01369212|141501062|SUPERIORITY|||||||0.66|||||||Fisher Exact|||||||0.66
70995977|NCT01369212|141501063|SUPERIORITY|||||||0.02|||||||Fisher Exact|||||||0.02
70995978|NCT01369212|141501064|SUPERIORITY|||||||0.55|||||||Fisher Exact|||||||0.55
70995979|NCT01369212|141501065|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
70995980|NCT01369212|141501066|SUPERIORITY|||||||0.87|||||||Fisher Exact|||||||0.87
70995981|NCT01369212|141501067|SUPERIORITY|||||||0.02|||||||Fisher Exact|||||||0.02
70995982|NCT01369212|141501068|SUPERIORITY|||||||0.66|||||||Fisher Exact|||||||0.66
70995983|NCT01369212|141501070|SUPERIORITY|||||||0.66|||||||Log Rank|||||||0.66
70995984|NCT01369212|141501071|SUPERIORITY|||||||0.01|||||||Fisher Exact|||||||0.01
70995985|NCT00862121|141501072|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.212||||0.231|TWO_SIDED|95.0|0.017|2.683|||Regression, Logistic|||The odds ratio (OR) for Baseline CDAI measures the effect of an increase of one unit on the outcome. The OR \[95% CI\] and p-value (likelihood-based) are for Pentasa versus placebo estimated in a logistic regression analysis including TREATMENT and CDAI at baseline as covariates. Power to demonstrate superiority of PENTASA Sachet 6 g/day over placebo in the primary efficacy analysis was 90% for a planned sample size of 255 participants per treatment arm (assuming 10% nonassessable participants).||2.683|0.017|0.231
70995986|NCT00475540|141501135|SUPERIORITY|Statistical analysis was performed using SAS 9.1 software. One patient did not receive the assigned mesh treatment because the surgeon felt there was inadequate vaginal caliber, so non mesh repair was performed. This subject was analyzed in the non mesh group for the 3-month and 1-year outcomes rather than intent-to-treat approach. This subject was lost to follow-up after 12 months and not included in the 3-year analysis.|||||<|0.05|||||||t-test, 2 sided|t-tests, Wilcoxon signed rank, Wilcoxon rank-sum tests continuous variables; X2 for categorical variables. Combined cure outcomes Fisher's exact test||Sample size primary outcome 1 year: 45 participants per arm, 20% difference success (70% no mesh and 90% mesh), alpha of .05 and 80% power, 15% loss to follow-up.||||<0.05
70995987|NCT01033487|141501147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0507|STANDARD_ERROR_OF_MEAN|0.0339|||ONE_SIDED|90.0|0.0059||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 90 percent (%) confidence interval (CI) was reported.|||0.0059|
70995988|NCT01033487|141501147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0788|STANDARD_ERROR_OF_MEAN|0.027|||ONE_SIDED|90.0|0.0431||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 90% CI was reported.|||0.0431|
70995989|NCT01033487|141501147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0927|STANDARD_ERROR_OF_MEAN|0.0277|||ONE_SIDED|90.0|0.056||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 90% CI was reported.|||0.0560|
70995990|NCT01033487|141501147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0613|STANDARD_ERROR_OF_MEAN|0.03|||ONE_SIDED|90.0|0.0215||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 90% CI was reported.|||0.0215|
70995991|NCT01033487|141501147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0105|STANDARD_ERROR_OF_MEAN|0.0309|||ONE_SIDED|80.0|-0.0371||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 80% CI was reported.|||-0.0371|
70995992|NCT01033487|141501147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0175|STANDARD_ERROR_OF_MEAN|0.0246|||ONE_SIDED|80.0|-0.0037||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 80% CI was reported.|||-0.0037|
70995993|NCT01033487|141501147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0315|STANDARD_ERROR_OF_MEAN|0.0294|||ONE_SIDED|80.0|0.0062||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 80% CI was reported.|||0.0062|
70995994|NCT01033487|141501156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0989|STANDARD_ERROR_OF_MEAN|0.242|||ONE_SIDED|90.0|0.0676||||ANOVA|||Mixed effects analysis of variance (ANOVA) was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.0676|
70995995|NCT01033487|141501156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1748|STANDARD_ERROR_OF_MEAN|0.0245|||ONE_SIDED|90.0|0.1431||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.1431|
70995996|NCT01033487|141501156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1909|STANDARD_ERROR_OF_MEAN|0.0243|||ONE_SIDED|90.0|0.1594||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.1594|
70995997|NCT01033487|141501156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1528|STANDARD_ERROR_OF_MEAN|0.0237|||ONE_SIDED|90.0|0.1222||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.1222|
70995998|NCT01033487|141501156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0539|STANDARD_ERROR_OF_MEAN|0.0239|||ONE_SIDED|90.0|-0.0849||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||-0.0849|
70995999|NCT01033487|141501156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_DEVIATION|0.0238|||ONE_SIDED|90.0|-0.0088||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||-0.0088|
70996000|NCT01033487|141501156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0381|STANDARD_ERROR_OF_MEAN|0.0242|||ONE_SIDED|90.0|0.0068||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.0068|
70996001|NCT01033487|141501157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0852|STANDARD_ERROR_OF_MEAN|0.0214|||ONE_SIDED|90.0|0.0576||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.0576|
70996002|NCT01033487|141501157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1418|STANDARD_ERROR_OF_MEAN|0.0219|||ONE_SIDED|90.0|0.1136||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.1136|
70996003|NCT01033487|141501157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1692|STANDARD_ERROR_OF_MEAN|0.0216|||ONE_SIDED|90.0|0.1413||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.1413|
70996004|NCT01033487|141501157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1526|STANDARD_ERROR_OF_MEAN|0.0212|||ONE_SIDED|90.0|0.1252||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.1252|
70923700|NCT01351805|141339156|OTHER|We assessed the main effects of the treatment arms comparing all those randomized to vitamin D or vitamin D placebo, regardless of omega-3 fatty acid randomization status.||||||0.41||||||Repeated measures model with unstructured variance to assess effect of treatment on WOMAC Pain adjusting for age, sex, and other treatment. Linear time by treatment interaction term assessed change in WOMAC Pain over time in treatment vs placebo.|Mixed Models Analysis|Linear time by treatment interaction (comparing change in WOMAC pain over time in two randomized groups)||Intention to treat analysis using a repeated measures model with unstructured variance to assess the effect of treatment arm on WOMAC Pain adjusting for age, sex, and the other treatment arm. The linear time by treatment interaction term assessed change in WOMAC Pain over time between participants randomized to treatment versus placebo.|We assessed for effect modification between vitamin D and N-3 FA and tested for other pre-specified interactions. We again used a repeated measures model with censoring for TKR. We adjusted for age, sex and N-3 FA treatment arm (in analyses in which N-3 FA treatment arm was not investigated as a potential modifier).|||0.41
70923701|NCT01351805|141339156|OTHER|Linear regression - WOMAC pain over time mean (Standard error - SE). Differences in WOMAC pain scores in stratified groups.|Mean Difference (Net)|-1.5|STANDARD_ERROR_OF_MEAN|1.9||0.42|TWO_SIDED||||||Regression, Linear|||Active n3fa vs placebo n3fa among those on placebo vitamin D.||||0.42
70923702|NCT01351805|141339156|OTHER|Linear regression - WOMAC pain over time mean (Standard error - SE). Differences in WOMAC pain scores in stratified groups.|Mean Difference (Net)|-2.5|STANDARD_ERROR_OF_MEAN|1.8||0.18|TWO_SIDED||||||Regression, Linear|||Vitamin D vs. vitamin D placebo among those on placebo omega-3 fatty acids- stratified analyses.||||0.18
70923703|NCT01351805|141339156|OTHER|Linear regression - WOMAC pain over time mean (Standard error - SE). Report only in final year. Differences in WOMAC pain scores in cross-classified groups.|Mean Difference (Net)|0.39|STANDARD_ERROR_OF_MEAN|1.89||0.84|TWO_SIDED||||||Regression, Linear|||Omega-3 fatty acids vs. omega-3 fatty acids placebo among those on active vitamin D.||||0.84
70923704|NCT01351805|141339156|OTHER|Linear regression - WOMAC pain over time mean (Standard error - SE). Report only in final year. Differences in WOMAC pain scores in cross-classified groups.|Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|1.8||0.76|TWO_SIDED||||||Regression, Linear|||Omega-3 fatty acids vs. omega-3 fatty acids placebo among those on placebo vitamin D.||||0.76
70923705|NCT05529966|141339212|OTHER|||||||0.45490734||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||||||0.45490734
70996005|NCT01033487|141501157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0674|STANDARD_ERROR_OF_MEAN|0.0211|||ONE_SIDED|90.0|-0.0946||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||-0.0946|
70923706|NCT05529966|141339213|OTHER|||||||0.9237611||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||||||0.92376110
70923707|NCT05529966|141339214|OTHER|||||||0.94342221||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||||||0.94342221
70923708|NCT05529966|141339215|OTHER|||||||0.38902793||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||||||0.38902793
70923709|NCT05529966|141339216|OTHER|||||||0.0042494||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of comfort score||||0.00424940
70923710|NCT05529966|141339216|OTHER|||||||0.00223547||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Visibility score||||.00223547
70923711|NCT05529966|141339216|OTHER|||||||1.858e-05||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Image Quality score||||.00001858
70923712|NCT05529966|141339216|OTHER|||||||0.03003194||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Focus score||||.03003194
70923713|NCT05529966|141339216|OTHER|||||||2.8e-07||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Depth Perception score||||.00000028
71040773|NCT03538262|141590134|OTHER|||||||0.837|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 9||||0.837
71040774|NCT03538262|141590134|OTHER|||||||0.394|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.394
70996006|NCT01033487|141501157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0108|STANDARD_ERROR_OF_MEAN|0.0213|||ONE_SIDED|90.0|-0.0383||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||-0.0383|
70996007|NCT01033487|141501157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0166|STANDARD_ERROR_OF_MEAN|0.213|||ONE_SIDED|90.0|-0.011||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||-0.0110|
70996008|NCT01512108|141501207|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.27||||0.0026||95.0|-0.44|-0.09|||ANOVA|||||-0.09|-0.44|0.0026
70996009|NCT01512108|141501208|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.3||||0.0458||95.0|-0.6|-0.01|||ANOVA|||||-0.01|-0.60|0.0458
70996010|NCT03864536|141501232|SUPERIORITY||||||<|0.05||||||The statistical significance level was set using alpha of 0.05 without multiplicity correction. This pilot study was not powered for all the outcomes so the magnitude and estimates of intervention efficacy was of primary interest.|Mixed Models Analysis|||||||<0.05
70996011|NCT03864536|141501233|SUPERIORITY||||||<|0.05||||||The statistical significance level was set using alpha of 0.05 without multiplicity correction. This pilot study was not powered for all the outcomes so the magnitude and estimates of intervention efficacy was of primary interest.|Mixed Models Analysis|||||||<0.05
70996012|NCT00640146|141501234|OTHER|||||||0.0213|||||||Fisher Exact|||Analysis was performed using Fisher exact test comparing the percentage of participants with a laxation response within 2 hours of the first dose of study drug, testing MNTX against placebo.||||0.0213
70996013|NCT00640146|141501235|OTHER|||||||0.0463|||||||Fisher Exact|||Analysis was performed using Fisher exact test comparing the percentage of participants with a laxation response within 4 hours of the first dose of study drug, testing MNTX against placebo.||||0.0463
70996014|NCT01634113|141501237|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.117||0.4963|TWO_SIDED|95.0|-0.312|0.152||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R2.5 minus placebo|||0.152|-0.312|0.4963
70996015|NCT01634113|141501237|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.048|STANDARD_ERROR_OF_MEAN|0.123||0.6936|TWO_SIDED|95.0|-0.292|0.195||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R5 minus placebo|||0.195|-0.292|0.6936
70996016|NCT01634113|141501239|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.083|STANDARD_ERROR_OF_MEAN|0.157||0.5995|TWO_SIDED|95.0|-0.229|0.394||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R2.5 minus placebo|||0.394|-0.229|0.5995
70996017|NCT01634113|141501239|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.015|STANDARD_ERROR_OF_MEAN|0.16||0.9251|TWO_SIDED|95.0|-0.303|0.333||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R5 minus placebo|||0.333|-0.303|0.9251
70996018|NCT01634113|141501240|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.25|STANDARD_ERROR_OF_MEAN|10.324||0.8279|TWO_SIDED|95.0|-18.243|22.743||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R2.5 minus placebo|||22.743|-18.243|0.8279
70996019|NCT01634113|141501240|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.497|STANDARD_ERROR_OF_MEAN|10.826||0.8181|TWO_SIDED|95.0|-23.987|18.994||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R5 minus placebo|||18.994|-23.987|0.8181
70996020|NCT01634113|141501242|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.061|STANDARD_ERROR_OF_MEAN|0.112||0.5869|TWO_SIDED|95.0|-0.161|0.283||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R2.5 minus placebo|||0.283|-0.161|0.5869
70996021|NCT01634113|141501242|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.075|STANDARD_ERROR_OF_MEAN|0.116||0.523|TWO_SIDED|95.0|-0.305|0.156||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R5 minus placebo|||0.156|-0.305|0.5230
70996022|NCT01357980|141501260|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-1.54||||0.11|TWO_SIDED|95.0|-3.47|0.39||No multiplicity adjustment applied: each test conducted at a 5% significance level.|ANCOVA|||Comparison of the average Daily IEF change from baseline to DAY 84 using ANCOVA with the baseline average daily IEF value as covariate.||0.39|-3.47|0.11
70996023|NCT01357980|141501260|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-0.61||||0.07|TWO_SIDED|95.0|-1.27|0.05||No multiplicity adjustment applied: each test conducted at a 5% significance level.|ANCOVA|||Comparison of the average Daily IEF change from baseline to DAY 84 using ANCOVA with the baseline average daily IEF value as covariate.||0.05|-1.27|0.07
70996024|NCT01357980|141501261|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|219.5|||<|0.01|TWO_SIDED|95.0|69.6|369.5|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 14 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.||369.5|69.6|<0.01
70996025|NCT01357980|141501261|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|224.1|||<|0.01|TWO_SIDED|95.0|140.9|307.4|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 14 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.||307.4|140.9|<0.01
70996026|NCT01357980|141501261|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|117.0||||0.09||95.0|-20.0|254.0|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 42 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.||254.0|-20.0|0.09
70996027|NCT01357980|141501261|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|223.7|||<|0.01|TWO_SIDED|95.0|94.3|353.1|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 42 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.||353.1|94.3|<0.01
70996028|NCT01357980|141501261|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|138.5||||0.01|TWO_SIDED|95.0|34.7|242.2|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 84 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.||242.2|34.7|0.01
70996029|NCT01357980|141501261|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|186.3|||<|0.01|TWO_SIDED|95.0|53.2|319.4|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 84 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.||319.4|53.2|<0.01
70996030|NCT01357980|141501262|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-23.8||||0.25|TWO_SIDED|95.0|-66.6|18.9|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 14 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.||18.9|-66.6|0.25
70996031|NCT01357980|141501262|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-67.1|||<|0.01|TWO_SIDED|95.0|-112.9|-21.2|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 14 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.||-21.2|-112.9|<0.01
70996032|NCT01357980|141501262|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-35.1||||0.03|TWO_SIDED|95.0|-65.6|-4.6|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 42 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.||-4.6|-65.6|0.03
70996033|NCT01357980|141501262|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-51.0||||0.01|TWO_SIDED|95.0|-89.5|-12.4|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 42 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.||-12.4|-89.5|0.01
70996034|NCT01357980|141501262|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-32.3|||<|0.01|TWO_SIDED|95.0|-53.7|-11.0|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 84 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.||-11.0|-53.7|<0.01
70996035|NCT01357980|141501262|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-45.3|||<|0.01|TWO_SIDED|95.0|-76.6|-14.1|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 84 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.||-14.1|-76.6|<0.01
70996036|NCT01357980|141501263|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|1.7||||0.05||95.0|||||Satterthwaite-Welch's t-test|||Comparison of the Physician's Global Assessment score at DAY 14 using a two sided Satterthwaite-Welch's t-test for independent samples.||||0.05
70996037|NCT01357980|141501263|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|2.3|||<|0.01|||||||Satterthwaite-Welch's t-test|||Comparison of the Physician's Global Assessment score at DAY 14 using a two sided Satterthwaite-Welch's t-test for independent samples.||||<0.01
71040775|NCT03538262|141590134|OTHER|||||||0.268|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 15||||0.268
71100100|NCT01866150|141708909|SUPERIORITY_OR_OTHER||Treatment difference|-0.15|STANDARD_ERROR_OF_MEAN|0.154||0.3264|TWO_SIDED|95.0|-0.45|0.15|||Mixed Models Analysis|||Comparison at the last visit. Analysis used a mixed model with month, cohort, baseline DAS28 score; cohort-by-month and cohort-by-baseline DAS28 score as fixed effects. Within-participant repeated measurements were incorporated with an unstructured variance-covariance structure.||0.15|-0.45|0.3264
71100101|NCT01866150|141708911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.81||||0.0237|TWO_SIDED|95.0|-16.44|-1.18|||General Linear Model|||Analysis was performed using a general linear model with cohort as a factor.||-1.18|-16.44|0.0237
71100102|NCT03160573|141708933|SUPERIORITY||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||Test Flavored Rinse, Placebo Flavored Rinse||||<0.00001
71100103|NCT03160573|141708933|SUPERIORITY||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||Test Unflavored Rinse, Placebo Unflavored Rinse||||<0.00001
71100104|NCT00594997|141708945|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||p\<0.05 threshold for statistical significance|Regression, Linear|||||||<0.0001
71100105|NCT01423084|141708946|NON_INFERIORITY_OR_EQUIVALENCE|Two different lots of rMenB+OMV NZ are to be considered equivalent in terms of hSBA GMTs against H44/76 strain if the two sided 95% Confidence Interval (CI) between groups GMTs ratio at day 31 (ie, one month after the second vaccination) does not exceed the range 0.5 (lower limit) - 2.0 (higher limit).|between groups ratio|1.0|||||TWO_SIDED|95.0|0.82|1.23||||||Equivalence of 2 different lots of rMenB+OMV NZ in terms of hSBA GMTs against H44/76 strain||1.23|0.82|
71100106|NCT01423084|141708946|NON_INFERIORITY_OR_EQUIVALENCE|Two different lots of rMenB+OMV NZ are to be considered equivalent in terms of hSBA GMTs against 5/99 strain if the two sided 95% Confidence Interval (CI) between groups GMTs ratio at day 31 (ie, one month after the second vaccination ) does not exceed the range 0.5 (lower limit) - 2.0 (higher limit).|between groups ratio|0.92|||||TWO_SIDED|95.0|0.77|1.1||||||Equivalence of 2 different lots of rMenB+OMV NZ in terms of hSBA GMTs against 5/99 strain||1.1|0.77|
71100107|NCT01423084|141708946|NON_INFERIORITY_OR_EQUIVALENCE|Two different lots of rMenB+OMV NZ are to be considered equivalent in terms of hSBA GMTs against NZ 98/254 strain if the two sided 95% Confidence Interval (CI) between groups GMTs ratio at day 31 (ie, one month after the second vaccination ) does not exceed the range 0.5 (lower limit) - 2.0 (higher limit).|between groups ratio|0.81|||||TWO_SIDED|95.0|0.6|1.09||||||Equivalence of 2 different lots of rMenB+OMV NZ in terms of hSBA GMTs against NZ98/254 strain||1.09|0.6|
71100108|NCT01423084|141708954|NON_INFERIORITY_OR_EQUIVALENCE|Two different lots of rMenB+OMV NZ are to be considered equivalent in terms of ELISA GMCs against vaccine antigen 287-953 if the two sided 95% Confidence Interval (CI) between groups GMTs ratio at day 31 (ie, one month after the second vaccination ) does not exceed the range 0.5 (lower limit) - 2.0 (higher limit).|between groups ratio|0.83|||||TWO_SIDED|95.0|0.67|1.02||||||Equivalence of 2 different lots of rMenB+OMV NZ in terms of hSBA GMTs||1.02|0.67|
71100109|NCT02462057|141708962|EQUIVALENCE|The anticipated sample size of 3500 provided 80% power to detect a 3% pairwise difference between the proportions of participants who enrolled in HF with significance testing conducted at the Bonferroni-corrected significance level of 0.005 (0.05/10) to account for the 10 pairwise between-arm comparisons and pessimistically allowing for up to 10% further exclusions. The baseline monthly enrolment rate was estimated at ∼1%/month.|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71100110|NCT02336555|141708963|SUPERIORITY||Mean Difference (Final Values)|-0.452||||0.075|TWO_SIDED|95.0|-1.076|0.172||Linear mixed model with a posterior probability evaluation for the treatment effect|Linear mixed model|One-sided p-value and a posterior probability greater than 90% that the treatment effect is less than 0.||||0.172|-1.076|0.075
71100111|NCT02336555|141708964|SUPERIORITY||Odds Ratio (OR)|1.073|||||TWO_SIDED|95.0|0.446|2.58|||||Logistic regression model with factors for treatment \& baseline pain intensity|||2.580|0.446|
71100112|NCT01633112|141708965|SUPERIORITY|For each of the 2 FTY720 doses, the null hypothesis was that there was no difference in the ARRs between subjects treated with FTY720 and those treated with GA versus the alternative hypothesis that there was a difference between the 2 treatment arms. In order to preserve the Type I experiment-wise error rate, the null hypothesis was rejected if the observed p-value for the between-treatment comparison was less than the significance level as specified in the multiplicity adjustment procedure.||||||0.0138|||||||negative binomial regression model|adjusted for treatment, geographical region, number of relapses in the previous year, baseline EDSS, and baseline Gd-enhancing T1 lesion count.||H01: µ FTY 0.5 mg = µ GA versus HA1: µ FTY 0.5 mg ≠µ GA H02: µ FTY 0.25 mg = µ GA versus HA2: µ FTY 0.25 mg ≠µ GA||||0.0138
70996038|NCT01357980|141501264|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|2.3||||0.01|||||||Satterthwaite-Welch's t-test|||Comparison of the Physician's Global Assessment score at DAY 42 using a two sided Satterthwaite-Welch's t-test for independent samples.||||0.01
71040776|NCT03538262|141590134|OTHER|||||||0.039|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 18||||0.039
71040777|NCT03538262|141590134|OTHER|||||||0.979|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 21||||0.979
71040778|NCT03538262|141590134|OTHER|||||||0.014|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||0.014
71040779|NCT03538262|141590135|OTHER|||||||0.285|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 3||||0.285
71040780|NCT03538262|141590135|OTHER|||||||0.267|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 9||||0.267
70923714|NCT05529966|141339216|OTHER|||||||0.00112148||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Staff Engagement score||||.00112148
70923715|NCT05529966|141339216|OTHER|||||||951||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Teaching score||||00000951
70923716|NCT05529966|141339216|OTHER|||||||0.03493564||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of En Face Confidence score||||.03493564
70996039|NCT01357980|141501264|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|1.8|||<|0.01|||||||Satterthwaite-Welch's t-test|||Comparison of the Physician's Global Assessment score at DAY 42 using a two sided Satterthwaite-Welch's t-test for independent samples.||||<0.01
70996040|NCT01357980|141501265|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|1.9||||0.05|||||||Satterthwaite-Welch's t-test|||Comparison of the Physician's Global Assessment score at DAY 84 using a two sided Satterthwaite-Welch's t-test for independent samples.||||0.05
70996041|NCT01357980|141501265|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|2.1|||<|0.01|||||||Satterthwaite-Welch's t-test|||Comparison of the Physician's Global Assessment score at DAY 84 using a two sided Satterthwaite-Welch's t-test for independent samples.||||<0.01
70996042|NCT01357980|141501266|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-1.13|||<|0.01|TWO_SIDED|95.0|-1.91|-0.35|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 14 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.||-0.35|-1.91|<0.01
70996043|NCT01357980|141501266|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-0.18||||0.7|TWO_SIDED|95.0|-1.26|0.9|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 14 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.||0.90|-1.26|0.7
70996044|NCT01357980|141501266|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-0.52||||0.3|TWO_SIDED|95.0|-1.56|0.52|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 42 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.||0.52|-1.56|0.3
70923717|NCT05529966|141339216|OTHER|||||||0.12895248||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Hydrus Placement Confidence score||||.12895248
70923718|NCT05529966|141339216|OTHER|||||||0.00279611||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Scope Preference score||||.00279611
70923719|NCT05529966|141339217|OTHER|||||||0.959638658||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Comfort score||||.959638658
70923720|NCT05529966|141339217|OTHER|||||||0.213464715||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Visibility score||||.213464715
70923721|NCT05529966|141339217|OTHER|||||||0.213464715||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Image Quality score||||.213464715
70923722|NCT05529966|141339217|OTHER|||||||0.155899777||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Focus score||||.155899777
70923723|NCT05529966|141339217|OTHER|||||||0.055960023||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Depth Perception score||||.055960023
70996045|NCT01357980|141501266|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-0.48||||0.3|TWO_SIDED|95.0|-1.47|0.52|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 42 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.||0.52|-1.47|0.3
70996046|NCT01357980|141501266|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-1.38|||<|0.01|TWO_SIDED|95.0|-2.02|-0.73|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 84 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.||-0.73|-2.02|<0.01
71040781|NCT03538262|141590135|OTHER|||||||0.564|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 15||||0.564
71040782|NCT03538262|141590135|OTHER|||||||0.034|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 21||||0.034
71040783|NCT03538262|141590136|OTHER|||||||0.409|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.409
71040784|NCT03538262|141590136|OTHER|||||||0.149|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 0.149||||0.149
71040785|NCT00926367|141590137|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Dunn's Multiple Comparisons Test|A two-tailed p≤ 0.05 was taken as the level of significance for all comparisons.||||||>0.05
71040786|NCT00926367|141590139|SUPERIORITY_OR_OTHER||||||>|0.05||||||A two-tailed p≤ 0.05 was taken as the level of significance for all comparisons.|Dunn's Multiple Comparisons Test|||||||>0.05
71040787|NCT02033317|141590157|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.14|TWO_SIDED||||||paired t-test|||||||= 0.14
71040788|NCT02033317|141590158|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.02|TWO_SIDED||||||paired t-test|||||||= 0.02
71040789|NCT02725411|141590193|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-0.38|0.35||||||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.35|-0.38|
71040790|NCT02725411|141590193|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|-0.6|0.13||||||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.13|-0.60|
70923724|NCT05529966|141339217|OTHER|||||||0.000685499||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Staff Engagement score||||.000685499
70923725|NCT05529966|141339217|OTHER|||||||0.004526118||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Teaching score||||.004526118
70923726|NCT05529966|141339217|OTHER|||||||0.299921137||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of En Face Confidence score||||.299921137
70923727|NCT05529966|141339217|OTHER|||||||0.368082084||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Hydrus Placement Confidence score||||.368082084
70923728|NCT05529966|141339217|OTHER|||||||0.015036417||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Scope Preference score||||.015036417
70923729|NCT04222660|141339218|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
70923730|NCT04222660|141339219|OTHER||||||<|0.0025|||||||t-test, 2 sided|||||||<0.0025
70923731|NCT04222660|141339220|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70923732|NCT04222660|141339221|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70923733|NCT04222660|141339222|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70923734|NCT04222660|141339223|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70923735|NCT04222660|141339224|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
70923736|NCT04222660|141339225|OTHER||||||<|0.0017|||||||t-test, 2 sided|||||||<0.0017
70923737|NCT04222660|141339226|OTHER||||||<|0.0195|||||||t-test, 2 sided|||||||<0.0195
70923738|NCT02520063|141339227|OTHER||||||||||||||||||The primary analysis was of safety and included all patients who received at least one dose of the investigational regimen. The rate of adverse events was be estimated at the end of the study along with two-sided 95% exact CIs (Clopper-Pearson intervals).|||
70923739|NCT04521478|141339288|OTHER||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|2.2||0.7636|TWO_SIDED|90.0|-3.0|4.3|||Mixed Models Analysis||Difference = (adjusted mean 5 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline MADRS total score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||4.3|-3.0|0.7636
70923740|NCT04521478|141339288|OTHER||Mean Difference (Net)|2.3|STANDARD_ERROR_OF_MEAN|2.2||0.304|TWO_SIDED|90.0|-1.4|5.9|||Mixed Models Analysis||Difference = (adjusted mean 25 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline MADRS total score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||5.9|-1.4|0.3040
70923741|NCT04521478|141339288|OTHER||Mean Difference (Net)|2.2|STANDARD_ERROR_OF_MEAN|2.2||0.309|TWO_SIDED|90.0|-1.4|5.7|||Mixed Models Analysis||Difference = (adjusted mean 75 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline MADRS total score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||5.7|-1.4|0.3090
70923742|NCT04521478|141339288|OTHER||Mean Difference (Net)|1.5|STANDARD_ERROR_OF_MEAN|1.7||0.3694|TWO_SIDED|90.0|-1.3|4.4|||Mixed Models Analysis||Difference = (adjusted mean 125 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline MADRS total score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||4.4|-1.3|0.3694
70923743|NCT04521478|141339288|OTHER|||||||0.9158|||||||MCPMod Linear model|No parameter assumptions required. Corresponding dose response is linear||The Multiple Comparison Procedures and Modeling (MCPMod) procedure used the estimated values from an MMRM model as input and allowed for simultaneous evaluation of different potential dose response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax), while protecting the overall false positive rate (probability of Type I error) using a one-sided, nominal α level of 10 %.||||0.9158
70923744|NCT04521478|141339288|OTHER|||||||0.8676|||||||MCPMod Exponential model|Assumption: 5% of the maximum effect is achieved at 25 mg; corresponding to a drug effect achieved mainly at higher doses||The Multiple Comparison Procedures and Modeling (MCPMod) procedure used the estimated values from an MMRM model as input and allowed for simultaneous evaluation of different potential dose response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax), while protecting the overall false positive rate (probability of Type I error) using a one-sided, nominal α level of 10 %.||||0.8676
70923745|NCT04521478|141339288|OTHER|||||||0.9552|||||||MCPMod Emax1 model|Assumption: 50% of the maximum effect is achieved at 25 mg; corresponding to the assumed true median effective dose (ED50) = 25 mg||The Multiple Comparison Procedures and Modeling (MCPMod) procedure used the estimated values from an MMRM model as input and allowed for simultaneous evaluation of different potential dose response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax), while protecting the overall false positive rate (probability of Type I error) using a one-sided, nominal α level of 10 %.||||0.9552
70996047|NCT01357980|141501266|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-0.4||||0.4|TWO_SIDED|95.0|-1.35|0.55|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 84 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.||0.55|-1.35|0.4
70996048|NCT02528253|141501269|SUPERIORITY||Least Square (LS) Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.1117|TWO_SIDED|95.0|-0.66|0.07|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. Analysis of covariance (ANCOVA) model for imputed datasets included treatment as a fixed effect, and baseline LBPI as a covariates, and study site as a random effect.||0.07|-0.66|0.1117
70996049|NCT02528253|141501269|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0281|TWO_SIDED|95.0|-0.76|-0.04|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline LBPI as a covariates, and study site as a random effect.||-0.04|-0.76|0.0281
71040791|NCT02725411|141590193|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-0.7|0.15||||||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.15|-0.70|
71040792|NCT02725411|141590193|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-0.93|-0.07||||||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.07|-0.93|
70996050|NCT02528253|141501270|SUPERIORITY||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.45||0.0035|TWO_SIDED|95.0|-2.21|-0.43|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.43|-2.21|0.0035
70923746|NCT04521478|141339288|OTHER|||||||0.9619|||||||MCPMod Emax2 model|Assumption: 70% of the maximum effect is achieved at 5 mg; corresponding to a drug effect achieved mainly with low doses, ED50 = 2.14 mg||The Multiple Comparison Procedures and Modeling (MCPMod) procedure used the estimated values from an MMRM model as input and allowed for simultaneous evaluation of different potential dose response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax), while protecting the overall false positive rate (probability of Type I error) using a one-sided, nominal α level of 10 %.||||0.9619
70923747|NCT04521478|141339288|OTHER|||||||0.9507|||||||MCPMod Sigmoid Emax model|Assumption: 50% of the maximum effect is achieved at 25 mg, 90% 75 mg; corresponding to a more flexible model of the assumed true ED50 = 25 mg||The Multiple Comparison Procedures and Modeling (MCPMod) procedure used the estimated values from an MMRM model as input and allowed for simultaneous evaluation of different potential dose response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax), while protecting the overall false positive rate (probability of Type I error) using a one-sided, nominal α level of 10 %.||||0.9507
70923748|NCT04521478|141339289|OTHER||Odds Ratio (OR)|0.9427||||0.8889|TWO_SIDED|90.0|0.4709|1.8873|||Regression, Logistic||5 mg BI 1358894 vs Placebo|Logistic regression model, including the fixed categorical effects of treatment and baseline MDD severity.||1.8873|0.4709|0.8889
70923749|NCT04521478|141339289|OTHER||Odds Ratio (OR)|0.6581||||0.3284|TWO_SIDED|90.0|0.3255|1.3307|||Regression, Logistic||25 mg BI 1358894 vs Placebo|Logistic regression model, including the fixed categorical effects of treatment and baseline MDD severity.||1.3307|0.3255|0.3284
70923750|NCT04521478|141339289|OTHER||Odds Ratio (OR)|1.1026||||0.8048|TWO_SIDED|90.0|0.5757|2.1114|||Regression, Logistic||75 mg BI 1358894 vs Placebo|Logistic regression model, including the fixed categorical effects of treatment and baseline MDD severity.||2.1114|0.5757|0.8048
70923751|NCT04521478|141339289|OTHER||Odds Ratio (OR)|1.0072||||0.982|TWO_SIDED|90.0|0.5968|1.6999|||Regression, Logistic||125 mg BI 1358894 vs Placebo|Logistic regression model, including the fixed categorical effects of treatment and baseline MDD severity.||1.6999|0.5968|0.9820
70923752|NCT04521478|141339290|OTHER||Mean Difference (Net)|4.3|STANDARD_ERROR_OF_MEAN|2.6||0.1013|TWO_SIDED|90.0|0.0|8.6|||Mixed Models Analysis||Difference = (adjusted mean 5 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (S-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||8.6|0.0|0.1013
70996051|NCT02528253|141501270|SUPERIORITY||LS Mean Difference|-1.74|STANDARD_ERROR_OF_MEAN|0.46||0.0002|TWO_SIDED|95.0|-2.64|-0.83|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.83|-2.64|0.0002
70996052|NCT02528253|141501271|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.17||0.3118|TWO_SIDED|95.0|-0.5|0.16|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.16|-0.50|0.3118
70996053|NCT02528253|141501271|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.17||0.0958|TWO_SIDED|95.0|-0.6|0.05|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.05|-0.60|0.0958
71040793|NCT02725411|141590193|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.69|0.33||||||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.33|-0.69|
70996054|NCT02528253|141501272|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.12||0.0015|TWO_SIDED|95.0|-0.6|-0.14|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.14|-0.60|0.0015
70996055|NCT02528253|141501272|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.12||0.0004|TWO_SIDED|95.0|-0.65|-0.19|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.19|-0.65|0.0004
70996056|NCT02528253|141501272|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.11||0.0959|TWO_SIDED|95.0|-0.39|0.03|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.03|-0.39|0.0959
70996057|NCT02528253|141501272|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.11||0.037|TWO_SIDED|95.0|-0.44|-0.01|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.01|-0.44|0.0370
70996058|NCT02528253|141501272|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14||0.0008|TWO_SIDED|95.0|-0.76|-0.2|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.20|-0.76|0.0008
70996059|NCT02528253|141501272|SUPERIORITY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.96|-0.39|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.39|-0.96|<.0001
70996060|NCT02528253|141501272|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.13||0.0711|TWO_SIDED|95.0|-0.5|0.02|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.02|-0.50|0.0711
70996061|NCT02528253|141501272|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.13||0.0661|TWO_SIDED|95.0|-0.5|0.02|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.02|-0.50|0.0661
70996062|NCT02528253|141501272|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.13||0.0009|TWO_SIDED|95.0|-0.7|-0.18|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.18|-0.70|0.0009
70996063|NCT02528253|141501272|SUPERIORITY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.16||0.0008|TWO_SIDED|95.0|-0.84|-0.22|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.22|-0.84|0.0008
70996064|NCT02528253|141501272|SUPERIORITY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.0|-0.38|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.38|-1.00|<.0001
70996065|NCT02528253|141501272|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.15||0.0274|TWO_SIDED|95.0|-0.61|-0.04|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.04|-0.61|0.0274
70996066|NCT02528253|141501272|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.15||0.1495|TWO_SIDED|95.0|-0.5|0.08|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.08|-0.50|0.1495
70996067|NCT02528253|141501272|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.15||0.0123|TWO_SIDED|95.0|-0.65|-0.08|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.08|-0.65|0.0123
70996068|NCT02528253|141501272|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.17||0.0307|TWO_SIDED|95.0|-0.71|-0.03|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.03|-0.71|0.0307
70996069|NCT02528253|141501272|SUPERIORITY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.17||0.0009|TWO_SIDED|95.0|-0.91|-0.24|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.24|-0.91|0.0009
70996070|NCT02528253|141501272|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.2103|TWO_SIDED|95.0|-0.51|0.11|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.11|-0.51|0.2103
70996071|NCT02528253|141501272|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.16||0.2656|TWO_SIDED|95.0|-0.48|0.13|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.13|-0.48|0.2656
70996072|NCT02528253|141501272|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.16||0.0152|TWO_SIDED|95.0|-0.68|-0.07|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.07|-0.68|0.0152
70996073|NCT02528253|141501272|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.19||0.5164|TWO_SIDED|95.0|-0.5|0.25|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.25|-0.50|0.5164
70996074|NCT02528253|141501272|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.19||0.1488|TWO_SIDED|95.0|-0.66|0.1|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.10|-0.66|0.1488
70996075|NCT02528253|141501272|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.19||0.2431|TWO_SIDED|95.0|-0.6|0.15|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.15|-0.60|0.2431
70996076|NCT02528253|141501272|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.2||0.2428|TWO_SIDED|95.0|-0.62|0.16|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.16|-0.62|0.2428
70996077|NCT02528253|141501272|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.2||0.4561|TWO_SIDED|95.0|-0.54|0.24|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.24|-0.54|0.4561
70996078|NCT02528253|141501272|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.2||0.3523|TWO_SIDED|95.0|-0.56|0.2|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.20|-0.56|0.3523
70996079|NCT02528253|141501272|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.2||0.4403|TWO_SIDED|95.0|-0.53|0.23|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.23|-0.53|0.4403
70996080|NCT02528253|141501272|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3205|TWO_SIDED|95.0|-0.58|0.19|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.19|-0.58|0.3205
70996081|NCT02528253|141501272|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.2||0.5763|TWO_SIDED|95.0|-0.51|0.28|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.28|-0.51|0.5763
70996082|NCT02528253|141501272|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.2||0.2887|TWO_SIDED|95.0|-0.61|0.18|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.18|-0.61|0.2887
70996083|NCT02528253|141501274|SUPERIORITY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.34||0.0121|TWO_SIDED|95.0|-1.5|-0.18|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.18|-1.50|0.0121
70996084|NCT02528253|141501274|SUPERIORITY||LS Mean Difference|-1.38|STANDARD_ERROR_OF_MEAN|0.34|<|0.0001|TWO_SIDED|95.0|-2.05|-0.71|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.71|-2.05|<.0001
70996085|NCT02528253|141501274|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.31||0.3697|TWO_SIDED|95.0|-0.89|0.33|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.33|-0.89|0.3697
70996086|NCT02528253|141501274|SUPERIORITY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.3||0.0658|TWO_SIDED|95.0|-1.16|0.04|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-1.16|0.0658
70996087|NCT02528253|141501274|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.31||0.0004|TWO_SIDED|95.0|-1.7|-0.5|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.50|-1.70|0.0004
70996088|NCT02528253|141501274|SUPERIORITY||LS Mean Difference|-1.22|STANDARD_ERROR_OF_MEAN|0.38||0.0013|TWO_SIDED|95.0|-1.96|-0.48|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.48|-1.96|0.0013
70996089|NCT02528253|141501274|SUPERIORITY||LS Mean Difference|-1.96|STANDARD_ERROR_OF_MEAN|0.38|<|0.0001|TWO_SIDED|95.0|-2.7|-1.21|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-1.21|-2.70|<.0001
70996090|NCT02528253|141501274|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.35||0.3906|TWO_SIDED|95.0|-0.99|0.39|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.39|-0.99|0.3906
70996091|NCT02528253|141501274|SUPERIORITY||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.35||0.0082|TWO_SIDED|95.0|-1.6|-0.24|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.24|-1.60|0.0082
70996092|NCT02528253|141501274|SUPERIORITY||LS Mean Difference|-1.65|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.34|-0.97|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.97|-2.34|<.0001
70996093|NCT02528253|141501274|SUPERIORITY||LS Mean Difference|-1.37|STANDARD_ERROR_OF_MEAN|0.4||0.0006|TWO_SIDED|95.0|-2.15|-0.58|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.58|-2.15|0.0006
70996094|NCT02528253|141501274|SUPERIORITY||LS Mean Difference|-1.95|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-2.73|-1.16|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-1.16|-2.73|<.0001
71040794|NCT02725411|141590193|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-1.09|-0.06||||||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.06|-1.09|
70996095|NCT02528253|141501274|SUPERIORITY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.37||0.0385|TWO_SIDED|95.0|-1.47|-0.04|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-1.47|0.0385
71040795|NCT02725411|141590193|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-0.94|0.27||||||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.27|-0.94|
71040796|NCT02725411|141590193|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-1.21|0.0||||||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.00|-1.21|
70996096|NCT02528253|141501274|SUPERIORITY||LS Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.37||0.0003|TWO_SIDED|95.0|-2.06|-0.61|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.61|-2.06|0.0003
71040797|NCT02725411|141590193|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-1.24|-0.03||||||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.03|-1.24|
71040798|NCT02725411|141590193|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-0.84|0.38||||||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.38|-0.84|
71040799|NCT02725411|141590193|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-1.53|0.01||||||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.01|-1.53|
70923753|NCT04521478|141339290|OTHER||Mean Difference (Net)|2.4|STANDARD_ERROR_OF_MEAN|2.6||0.3596|TWO_SIDED|90.0|-1.9|6.6|||Mixed Models Analysis||Difference = (adjusted mean 25 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (S-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||6.6|-1.9|0.3596
70923754|NCT04521478|141339290|OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|2.5||0.6745|TWO_SIDED|90.0|-5.2|3.1|||Mixed Models Analysis||Difference = (adjusted mean 75 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (S-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||3.1|-5.2|0.6745
70923755|NCT04521478|141339290|OTHER||Mean Difference (Net)|2.7|STANDARD_ERROR_OF_MEAN|2.0||0.187|TWO_SIDED|90.0|-0.7|6.0|||Mixed Models Analysis||Difference = (adjusted mean 125 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (S-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||6.0|-0.7|0.1870
70923756|NCT04521478|141339290|OTHER||Mean Difference (Net)|4.1|STANDARD_ERROR_OF_MEAN|2.4||0.0921|TWO_SIDED|90.0|0.1|8.1|||Mixed Models Analysis||Difference = (adjusted mean 5 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (T-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||8.1|0.1|0.0921
70923757|NCT04521478|141339290|OTHER||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|2.4||0.7395|TWO_SIDED|90.0|-3.2|4.8|||Mixed Models Analysis||Difference = (adjusted mean 25 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (T-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||4.8|-3.2|0.7395
70923758|NCT04521478|141339290|OTHER||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|2.4||0.6296|TWO_SIDED|90.0|-2.7|5.0|||Mixed Models Analysis||Difference = (adjusted mean 75 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (T-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||5.0|-2.7|0.6296
70923759|NCT04521478|141339290|OTHER||Mean Difference (Net)|3.8|STANDARD_ERROR_OF_MEAN|1.9||0.0429|TWO_SIDED|90.0|0.7|6.9|||Mixed Models Analysis||Difference = (adjusted mean 125 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (T-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||6.9|0.7|0.0429
70923760|NCT04521478|141339291|OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.6211|TWO_SIDED|90.0|-0.3|0.5|||Mixed Models Analysis||Difference = (adjusted mean 5 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||0.5|-0.3|0.6211
70923761|NCT04521478|141339291|OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.5158|TWO_SIDED|90.0|-0.2|0.6|||Mixed Models Analysis||Difference = (adjusted mean 25 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||0.6|-0.2|0.5158
70923762|NCT04521478|141339291|OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4518|TWO_SIDED|90.0|-0.2|0.6|||Mixed Models Analysis||Difference = (adjusted mean 75 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||0.6|-0.2|0.4518
71040800|NCT02725411|141590193|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-1.07|0.47||||||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.47|-1.07|
70996097|NCT02528253|141501274|SUPERIORITY||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.45||0.0035|TWO_SIDED|95.0|-2.21|-0.43|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.43|-2.21|0.0035
70996098|NCT02528253|141501274|SUPERIORITY||LS Mean Difference|-1.74|STANDARD_ERROR_OF_MEAN|0.46||0.0002|TWO_SIDED|95.0|-2.64|-0.83|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.83|-2.64|0.0002
71100113|NCT01633112|141708965|SUPERIORITY|For each of the 2 FTY720 doses, the null hypothesis was that there was no difference in the ARRs between subjects treated with FTY720 and those treated with GA versus the alternative hypothesis that there was a difference between the 2 treatment arms. In order to preserve the Type I experiment-wise error rate, the null hypothesis was rejected if the observed p-value for the between-treatment comparison was less than the significance level as specified in the multiplicity adjustment procedure.||||||0.4153|||||||negative binomial regression model|adjusted for treatment, geographical region, number of relapses in the previous year, baseline EDSS, and baseline Gd-enhancing T1 lesion count.||H01: µ FTY 0.5 mg = µ GA versus HA1: µ FTY 0.5 mg ≠µ GA H02: µ FTY 0.25 mg = µ GA versus HA2: µ FTY 0.25 mg ≠µ GA||||0.4153
70996099|NCT02528253|141501274|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.42||0.5412|TWO_SIDED|95.0|-1.09|0.57|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.57|-1.09|0.5412
70996100|NCT02528253|141501274|SUPERIORITY||LS Mean Difference|-1.06|STANDARD_ERROR_OF_MEAN|0.42||0.0107|TWO_SIDED|95.0|-1.87|-0.25|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.25|-1.87|0.0107
70996101|NCT02528253|141501274|SUPERIORITY||LS Mean Difference|-1.48|STANDARD_ERROR_OF_MEAN|0.42||0.0004|TWO_SIDED|95.0|-2.29|-0.66|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.66|-2.29|0.0004
70996102|NCT02528253|141501274|SUPERIORITY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.49||0.0464|TWO_SIDED|95.0|-1.94|-0.02|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-1.94|0.0464
70996103|NCT02528253|141501274|SUPERIORITY||LS Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|0.49||0.0068|TWO_SIDED|95.0|-2.3|-0.37|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.37|-2.30|0.0068
70996104|NCT02528253|141501274|SUPERIORITY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.5||0.1485|TWO_SIDED|95.0|-1.7|0.26|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.26|-1.70|0.1485
70996105|NCT02528253|141501274|SUPERIORITY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.5||0.0507|TWO_SIDED|95.0|-1.94|0.0|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.00|-1.94|0.0507
71100114|NCT01633112|141708966|OTHER||||||<|0.0001|||||||negative binomial regression model|Adjusted for treatment, geog. region, age, baseline T2 lesion count, baseline Gd-enhancing T1 lesion count, and the number of previous year relapses.||||||<0.0001
71100115|NCT01633112|141708966|OTHER||||||<|0.0001|||||||negative binomial regression model|Adjusted for treatment, geog. region, age, baseline T2 lesion count, baseline Gd-enhancing T1 lesion count, and the number of previous year relapses.||||||<0.0001
70996106|NCT02528253|141501274|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.51||0.248|TWO_SIDED|95.0|-1.6|0.41|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.41|-1.60|0.2480
70996107|NCT02528253|141501274|SUPERIORITY||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.51||0.1605|TWO_SIDED|95.0|-1.71|0.28|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.28|-1.71|0.1605
71100116|NCT01633112|141708968|OTHER||||||<|0.0001|||||||ANCOVA|rank ANCOVA with covariates: adjusted for treatment, age, region, number of relapses experienced in the previous year, and baseline T2 lesion volume.||||||<0.0001
71100117|NCT01633112|141708968|OTHER|||||||0.006|||||||ANCOVA|rank ANCOVA with covariates: adjusted for treatment, age, region, number of relapses experienced in the previous year, and baseline T2 lesion volume.||||||0.0060
71100118|NCT01633112|141708969|OTHER|||||||0.0167|||||||negative binomial regression model|adjusted for treatment, age, geog. region, baseline T2 lesion count, baseline Gd-enhancing T1 lesion count, and the number of previous year relapses .||||||0.0167
71100119|NCT01633112|141708969|OTHER|||||||0.0011|||||||negative binomial regression model|adjusted for treatment, age, geog. region, baseline T2 lesion count, baseline Gd-enhancing T1 lesion count, and the number of previous year relapses.||||||0.0011
70996108|NCT02528253|141501274|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.52||0.3654|TWO_SIDED|95.0|-1.5|0.55|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.55|-1.50|0.3654
70996109|NCT02528253|141501274|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.52||0.1782|TWO_SIDED|95.0|-1.71|0.32|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.32|-1.71|0.1782
70996110|NCT02528253|141501274|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.52||0.3981|TWO_SIDED|95.0|-1.47|0.58|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.58|-1.47|0.3981
71100120|NCT01633112|141708970|OTHER|||||||0.0052|||||||ANCOVA|ranked ANCOVA with covariates: treatment, region, age, baseline Gd-enhancing T1 lesion volume, and number ofrelapses experienced in the previous year.||||||0.0052
71100121|NCT01633112|141708970|OTHER|||||||0.0636|||||||ANCOVA|ranked ANCOVA with covariates: treatment, region, age, baseline Gd-enhancing T1 lesion volume, and number ofrelapses experienced in the previous year.||||||0.0636
70996111|NCT02528253|141501274|SUPERIORITY||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.52||0.1089|TWO_SIDED|95.0|-1.84|0.18|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.18|-1.84|0.1089
70996112|NCT02528253|141501276|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.1472|TWO_SIDED|95.0|-0.18|0.03|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.18|0.1472
70996113|NCT02528253|141501276|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.05||0.0135|TWO_SIDED|95.0|-0.24|-0.03|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.03|-0.24|0.0135
70996114|NCT02528253|141501276|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.0893|TWO_SIDED|95.0|-0.18|0.01|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.01|-0.18|0.0893
70996115|NCT02528253|141501276|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.05||0.0044|TWO_SIDED|95.0|-0.23|-0.04|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-0.23|0.0044
70996116|NCT02528253|141501276|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.0025|TWO_SIDED|95.0|-0.28|-0.06|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.06|-0.28|0.0025
70996117|NCT02528253|141501276|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.06||0.0002|TWO_SIDED|95.0|-0.32|-0.1|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.10|-0.32|0.0002
71100122|NCT01633112|141708971|OTHER|||||||0.0011||||||adjusted for treatment, region, age, proper baseline T1 lesion variable, baseline Gd-enhancing T1 lesion count and number of previous year relapses.|Regression, Logistic|pair-wise comparisons between treatment groups using a logistic regression model.||||||0.0011
70996118|NCT02528253|141501276|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.8348|TWO_SIDED|95.0|-0.11|0.09|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.09|-0.11|0.8348
70996119|NCT02528253|141501276|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.05||0.002|TWO_SIDED|95.0|-0.26|-0.06|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.06|-0.26|0.0020
70996120|NCT02528253|141501276|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.05||0.0001|TWO_SIDED|95.0|-0.3|-0.1|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.10|-0.30|0.0001
71100123|NCT01633112|141708971|OTHER|||||||0.0146||||||adjusted for treatment, region, age, proper baseline T1 lesion variable, baseline Gd-enhancing T1 lesion count and number of previous year relapses.|Regression, Logistic|pair-wise comparisons between treatment groups using a logistic regression model.||||||0.0146
71100124|NCT01633112|141708972|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
71100125|NCT01633112|141708972|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
71100126|NCT01633112|141708972|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
71100127|NCT01633112|141708972|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
71040801|NCT02725411|141590193|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-1.65|-0.08||||||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.08|-1.65|
70996121|NCT02528253|141501276|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.06||0.0272|TWO_SIDED|95.0|-0.25|-0.01|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.01|-0.25|0.0272
70996122|NCT02528253|141501276|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.06||0.0009|TWO_SIDED|95.0|-0.31|-0.08|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.08|-0.31|0.0009
71040802|NCT02725411|141590193|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.06|0.55||||||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.55|-1.06|
71040803|NCT02725411|141590193|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-1.72|-0.15||||||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.15|-1.72|
70996123|NCT02528253|141501276|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.05||0.168|TWO_SIDED|95.0|-0.18|0.03|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.18|0.1680
70996124|NCT02528253|141501276|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.05||0.2968|TWO_SIDED|95.0|-0.16|0.05|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.16|0.2968
70996125|NCT02528253|141501276|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0219|TWO_SIDED|95.0|-0.23|-0.02|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.23|0.0219
70996126|NCT02528253|141501276|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.0717|TWO_SIDED|95.0|-0.25|0.01|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.01|-0.25|0.0717
70996127|NCT02528253|141501276|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.0207|TWO_SIDED|95.0|-0.29|-0.02|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.29|0.0207
70996128|NCT02528253|141501276|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.8399|TWO_SIDED|95.0|-0.11|0.13|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.11|0.8399
70996129|NCT02528253|141501276|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.06||0.0299|TWO_SIDED|95.0|-0.25|-0.01|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.01|-0.25|0.0299
70996130|NCT02528253|141501276|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.006|TWO_SIDED|95.0|-0.29|-0.05|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.05|-0.29|0.0060
70996131|NCT02528253|141501276|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.1974|TWO_SIDED|95.0|-0.24|0.05|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.24|0.1974
70996132|NCT02528253|141501276|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.278|TWO_SIDED|95.0|-0.22|0.06|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.06|-0.22|0.2780
71100128|NCT01633112|141708972|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
71100129|NCT01633112|141708972|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
71100130|NCT01633112|141708972|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
71100131|NCT01633112|141708972|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
71100132|NCT01633112|141708972|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
70996133|NCT02528253|141501276|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.433|TWO_SIDED|95.0|-0.21|0.09|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.09|-0.21|0.4330
71040804|NCT02725411|141590193|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.05|0.54||||||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.54|-1.05|
70996134|NCT02528253|141501276|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.4946|TWO_SIDED|95.0|-0.2|0.09|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.09|-0.20|0.4946
70996135|NCT02528253|141501276|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.1884|TWO_SIDED|95.0|-0.25|0.05|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.25|0.1884
70996136|NCT02528253|141501276|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.08||0.521|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.20|0.5210
70996137|NCT02528253|141501276|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.08||0.3329|TWO_SIDED|95.0|-0.23|0.08|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.08|-0.23|0.3329
70996138|NCT02528253|141501276|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.08||0.5173|TWO_SIDED|95.0|-0.21|0.1|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.21|0.5173
70996139|NCT02528253|141501276|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.2346|TWO_SIDED|95.0|-0.25|0.06|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.06|-0.25|0.2346
71040805|NCT02725411|141590193|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.8|-0.15||||||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.15|-1.80|
71100133|NCT01633112|141708972|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
71100134|NCT01633112|141708972|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
71040806|NCT02725411|141590193|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.04|0.61||||||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.61|-1.04|
70996140|NCT02528253|141501276|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.08||0.3634|TWO_SIDED|95.0|-0.23|0.09|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.09|-0.23|0.3634
70996141|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0007|TWO_SIDED|95.0|1.26|2.39|||Regression, Logistic|||Week 2, \>=30%: Odds ratio (OR) and 95% Confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.39|1.26|0.0007
70996142|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0004|TWO_SIDED|95.0|1.29|2.44|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.44|1.29|0.0004
71100135|NCT01633112|141708972|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
71100136|NCT01633112|141708972|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Side Effects (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
71100137|NCT01633112|141708972|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Side Effects (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
71100138|NCT01633112|141708972|OTHER|||||||0.0005|||||||Wilcoxon signed-rank test|Side Effects (Month 6): p-values for within treatment comparison from baseline||||||0.0005
71100139|NCT01633112|141708972|OTHER||||||<|0.0051|||||||Wilcoxon signed-rank test|Side Effects (Month 12): p-values for within treatment comparison from baseline||||||<0.0051
71100140|NCT01633112|141708972|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Side Effects (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
71100141|NCT01633112|141708972|OTHER|||||||0.0051|||||||Wilcoxon signed-rank test|Side Effects (Month 12): p-values for within treatment comparison from baseline||||||0.0051
71040807|NCT02725411|141590193|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.65|-0.05||||||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.05|-1.65|
71100142|NCT01633112|141708972|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Convenience (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
71040808|NCT02725411|141590193|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-0.88|0.71||||||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.71|-0.88|
71040809|NCT02725411|141590195|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.77|0.04||||||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.04|-1.77|
71040810|NCT02725411|141590195|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.96|-0.14||||||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||-0.14|-1.96|
71040811|NCT02725411|141590195|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-1.48|0.43||||||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.43|-1.48|
71040812|NCT02725411|141590195|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-1.43|0.51||||||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.51|-1.43|
71040813|NCT02725411|141590195|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-1.04|0.91||||||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.91|-1.04|
71040814|NCT02725411|141590195|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-1.53|0.44||||||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.44|-1.53|
71040815|NCT02725411|141590195|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-1.06|1.05||||||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||1.05|-1.06|
71040816|NCT02725411|141590195|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-1.6|0.53||||||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.53|-1.60|
71040817|NCT02725411|141590195|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-1.71|0.88||||||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.88|-1.71|
71040818|NCT02725411|141590195|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-1.47|1.14||||||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||1.14|-1.47|
71040819|NCT02725411|141590195|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|95.0|-1.9|0.71||||||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.71|-1.90|
71040820|NCT02725411|141590195|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-1.44|1.25||||||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||1.25|-1.44|
71040821|NCT02725411|141590195|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-2.43|0.28||||||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.28|-2.43|
71040822|NCT02725411|141590195|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-1.41|1.32||||||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||1.32|-1.41|
70996143|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.14||||0.3456|TWO_SIDED|95.0|0.87|1.5|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.50|0.87|0.3456
70996144|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.16||||0.2771|TWO_SIDED|95.0|0.89|1.53|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.53|0.89|0.2771
70996145|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.54||||0.0594|TWO_SIDED|95.0|0.98|2.41|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.41|0.98|0.0594
70996146|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0105|TWO_SIDED|95.0|1.14|2.75|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.75|1.14|0.0105
70996147|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.29||||0.236|TWO_SIDED|95.0|0.85|1.98|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.98|0.85|0.2360
70996148|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.19||||0.3746|TWO_SIDED|95.0|0.81|1.75|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.75|0.81|0.3746
70996149|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.37||||0.0974|TWO_SIDED|95.0|0.94|1.99|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.99|0.94|0.0974
70996150|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.94||||0.0806|TWO_SIDED|95.0|0.92|4.08|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||4.08|0.92|0.0806
70996151|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|2.15||||0.0407|TWO_SIDED|95.0|1.03|4.47|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||4.47|1.03|0.0407
70996152|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.22||||0.5966|TWO_SIDED|95.0|0.58|2.58|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.58|0.58|0.5966
70996153|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.59||||0.1492|TWO_SIDED|95.0|0.85|2.96|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.96|0.85|0.1492
71040823|NCT02725411|141590195|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-2.17|0.57||||||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.57|-2.17|
70996154|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.76||||0.072|TWO_SIDED|95.0|0.95|3.24|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||3.24|0.95|0.0720
70996155|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9926|TWO_SIDED|95.0|0.25|4.0|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||4.00|0.25|0.9926
70996156|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.75||||0.3726|TWO_SIDED|95.0|0.51|6.04|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||6.04|0.51|0.3726
70996157|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|0.83||||0.7874|TWO_SIDED|95.0|0.22|3.12|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||3.12|0.22|0.7874
70996158|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.19||||0.795|TWO_SIDED|95.0|0.32|4.46|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||4.46|0.32|0.7950
70996159|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|2.1||||0.2065|TWO_SIDED|95.0|0.66|6.68|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||6.68|0.66|0.2065
70996160|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0006|TWO_SIDED|95.0|1.23|2.17|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.17|1.23|0.0006
70996161|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|2.05|||<|0.0001|TWO_SIDED|95.0|1.55|2.72|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.72|1.55|<.0001
70996162|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.32||||0.0387|TWO_SIDED|95.0|1.01|1.71|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.71|1.01|0.0387
70996163|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.24||||0.0903|TWO_SIDED|95.0|0.97|1.6|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.60|0.97|0.0903
70996164|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0006|TWO_SIDED|95.0|1.21|2.01|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.01|1.21|0.0006
70996165|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.5||||0.0166|TWO_SIDED|95.0|1.08|2.09|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.09|1.08|0.0166
71100143|NCT01633112|141708972|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Convenience (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
70996166|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.89||||0.0001|TWO_SIDED|95.0|1.36|2.62|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.62|1.36|0.0001
70996167|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.27||||0.1389|TWO_SIDED|95.0|0.93|1.73|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.73|0.93|0.1389
70996168|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.19||||0.2504|TWO_SIDED|95.0|0.89|1.59|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.59|0.89|0.2504
70996169|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.49||||0.0057|TWO_SIDED|95.0|1.12|1.98|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.98|1.12|0.0057
70996170|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0126|TWO_SIDED|95.0|1.14|2.93|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.93|1.14|0.0126
70996171|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|2.69|||<|0.0001|TWO_SIDED|95.0|1.71|4.22|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||4.22|1.71|<.0001
70996172|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.25||||0.3485|TWO_SIDED|95.0|0.79|1.99|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.99|0.79|0.3485
70996173|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.46||||0.0642|TWO_SIDED|95.0|0.98|2.19|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.19|0.98|0.0642
70996174|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|2.16|||<|0.0001|TWO_SIDED|95.0|1.48|3.14|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||3.14|1.48|<.0001
70996175|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9819|TWO_SIDED|95.0|0.42|2.31|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.31|0.42|0.9819
70996176|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.37||||0.4333|TWO_SIDED|95.0|0.62|3.02|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||3.02|0.62|0.4333
70996177|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|0.91||||0.814|TWO_SIDED|95.0|0.41|2.0|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.00|0.41|0.8140
70996178|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.09||||0.8331|TWO_SIDED|95.0|0.49|2.4|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.40|0.49|0.8331
70996179|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.51||||0.2682|TWO_SIDED|95.0|0.73|3.12|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||3.12|0.73|0.2682
70996180|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.73||||0.0001|TWO_SIDED|95.0|1.31|2.29|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.29|1.31|0.0001
70996181|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.97|||<|0.0001|TWO_SIDED|95.0|1.49|2.61|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.61|1.49|<.0001
70996182|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0071|TWO_SIDED|95.0|1.1|1.83|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.83|1.10|0.0071
70996183|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.22||||0.1187|TWO_SIDED|95.0|0.95|1.57|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.57|0.95|0.1187
70996184|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.39||||0.011|TWO_SIDED|95.0|1.08|1.79|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.79|1.08|0.0110
70996185|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0003|TWO_SIDED|95.0|1.3|2.39|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.39|1.30|0.0003
70996186|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|2.12|||<|0.0001|TWO_SIDED|95.0|1.57|2.87|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.87|1.57|<.0001
70996187|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0069|TWO_SIDED|95.0|1.11|1.97|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.97|1.11|0.0069
70996188|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.19||||0.2076|TWO_SIDED|95.0|0.91|1.55|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.55|0.91|0.2076
70996189|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.43||||0.0072|TWO_SIDED|95.0|1.1|1.86|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.86|1.10|0.0072
70996190|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0694|TWO_SIDED|95.0|0.97|2.22|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.22|0.97|0.0694
70996191|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|2.27|||<|0.0001|TWO_SIDED|95.0|1.53|3.36|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||3.36|1.53|<.0001
70996192|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.36||||0.121|TWO_SIDED|95.0|0.92|2.0|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.00|0.92|0.1210
70996193|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.08||||0.6706|TWO_SIDED|95.0|0.76|1.54|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.54|0.76|0.6706
70996194|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.67||||0.0022|TWO_SIDED|95.0|1.2|2.32|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.32|1.20|0.0022
71100144|NCT01633112|141708972|OTHER|||||||0.0068|||||||Wilcoxon signed-rank test|Convenience (Month 6): p-values for within treatment comparison from baseline||||||0.0068
71100145|NCT01633112|141708972|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Convenience (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
71100146|NCT01633112|141708972|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Convenience (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
71100147|NCT01633112|141708972|OTHER|||||||0.4595|||||||Wilcoxon signed-rank test|Convenience (Month 12): p-values for within treatment comparison from baseline||||||0.4595
71100148|NCT01633112|141708973|OTHER|||||||0.1045|||||||ANCOVA|rank ANCOVA model adjusted for treatment, region, age, the number of relapses experienced in the previous year, and baseline normalized brain volume||||||0.1045
71100149|NCT01633112|141708973|OTHER|||||||0.1358|||||||ANCOVA|rank ANCOVA model adjusted for treatment, region, age, the number of relapses experienced in the previous year, and baseline normalized brain volume||||||0.1358
71100150|NCT01959919|141708974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.907||||0|||||||Wilcoxon Signed Ranks Test|||Comparison between ease of using clotting factor treatment score at Final visit (Month 8) and baseline visit||||0.000
70996195|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.12||||0.7546|TWO_SIDED|95.0|0.56|2.22|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.22|0.56|0.7546
70996196|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.13||||0.7347|TWO_SIDED|95.0|0.57|2.24|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.24|0.57|0.7347
70996197|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|0.96||||0.9029|TWO_SIDED|95.0|0.5|1.84|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.84|0.50|0.9029
70996198|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.16||||0.6402|TWO_SIDED|95.0|0.62|2.18|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.18|0.62|0.6402
71100151|NCT01959919|141708975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.572|STANDARD_ERROR_OF_MEAN|0.584||0|TWO_SIDED|95.0|3.411|5.733|||t-test, 2 sided|||Comparison between time for reconstructing the drug at Final visit (Month 8) and baseline visit||5.733|3.411|0.000
71100152|NCT01959919|141708976|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.789||||0|||||||Wilcoxon Signed Ranks Test|||Comparison between burden of clotting factor treatment score at Final Visit Month 8 and baseline visit||||0.000
71100153|NCT01959919|141708977|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.98||||0|||||||Wilcoxon Signed Ranks Test|||Comparison between impact of clotting factor treatment score at Final Visit Month 8 and baseline visit||||0.000
71100154|NCT01959919|141708978|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.445||||0.001|||||||Wilcoxon Signed Ranks Test|||Comparison between risk associated with clotting factor treatment score at Final Visit Month 8 and baseline visit||||0.001
71100155|NCT01697501|141708987|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.7831|TWO_SIDED|95.0|0.29|2.57|||univariate logistic analysis|||||2.57|0.29|0.7831
71100156|NCT01697501|141708988|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.25||||0.1951|TWO_SIDED|95.0|0.66|7.67|||univariate logistic analysis|||||7.67|0.66|0.1951
71100157|NCT01697501|141708989|SUPERIORITY_OR_OTHER|||||||0.2642|TWO_SIDED||||||Wald Chi Square|||||||0.2642
71100158|NCT01697501|141708990|SUPERIORITY_OR_OTHER|||||||0.0672|TWO_SIDED||||||Wald Chi Square|||||||0.0672
71100159|NCT03992872|141708995|SUPERIORITY|The significance of the difference between groups in seroconversion rates was assessed using a Fisher's exact test. The percentage who seroconverted in each group was presented along with its 95% CI calculated using the Wilson method. The Newcombe method was use to estimate the 95% confidence interval for the difference between groups in the percentage of subjects who seroconverted.|Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-11.4|11.4|||Fisher Exact|||||11.4|-11.4|1
71100160|NCT03992872|141708996|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|1.2|||||TWO_SIDED|95.0||||P- value = NE (Not estimable due to lack of response; all baseline values in this group were \<LOD and imputed as LOD/2, or 7.5)||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|"Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.~95% CI \[NE,NE\]~NE = Not estimable due to lack of response."|Day 1: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||||
70996199|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.17||||0.6199|TWO_SIDED|95.0|0.62|2.2|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.20|0.62|0.6199
70996200|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0229|TWO_SIDED|95.0|1.05|1.83|||Regression, Logistic|||Week 12, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.83|1.05|0.0229
70996201|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.73||||0.0002|TWO_SIDED|95.0|1.3|2.3|||Regression, Logistic|||Week 12, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.30|1.30|0.0002
71040824|NCT02725411|141590195|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.71|||TWO_SIDED|95.0|-1.16|1.64||||||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||1.64|-1.16|
71040825|NCT02725411|141590195|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-2.37|0.35||||||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.35|-2.37|
71040826|NCT02725411|141590195|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.71|||TWO_SIDED|95.0|-1.35|1.42||||||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||1.42|-1.35|
71040827|NCT02725411|141590199|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|13.0|||||TWO_SIDED|95.0|-0.8|26.3||||||Week 16: \>=30%||26.3|-0.8|
71040828|NCT02725411|141590199|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|-1.7|||||TWO_SIDED|95.0|-15.8|12.4||||||Week 16: \>=30%||12.4|-15.8|
71040829|NCT02725411|141590199|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|18.5|||||TWO_SIDED|95.0|4.2|32.0||||||Week 16: \>=50%||32.0|4.2|
71040830|NCT02725411|141590199|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|2.9|||||TWO_SIDED|95.0|-10.7|16.3||||||Week 16: \>=50%||16.3|-10.7|
71040831|NCT02725411|141590199|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|10.9|||||TWO_SIDED|95.0|0.6|20.7||||||Week 16: \>=70%||20.7|0.6|
71040832|NCT02725411|141590199|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|8.5|||||TWO_SIDED|95.0|-1.4|18.1||||||Week 16: \>=70%||18.1|-1.4|
71040833|NCT02725411|141590199|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|1.1|||||TWO_SIDED|95.0|-4.3|6.5||||||Week 16: \>=90%||6.5|-4.3|
71040834|NCT02725411|141590199|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|2.1|||||TWO_SIDED|95.0|-3.7|7.8||||||Week 16: \>=90%||7.8|-3.7|
71040835|NCT02725411|141590199|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|12.0|||||TWO_SIDED|95.0|-2.3|25.7||||||Week 24: \>=30%||25.7|-2.3|
71040836|NCT02725411|141590199|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|-1.6|||||TWO_SIDED|95.0|-15.9|12.6||||||Week 24: \>=30%||12.6|-15.9|
70996202|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.14||||0.315|TWO_SIDED|95.0|0.88|1.47|||Regression, Logistic|||Week 12, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.47|0.88|0.3150
71040837|NCT02725411|141590199|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|12.0|||||TWO_SIDED|95.0|-2.4|25.8||||||Week 24: \>=50%||25.8|-2.4|
71040838|NCT02725411|141590199|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|5.0|||||TWO_SIDED|95.0|-9.1|18.9||||||Week 24: \>=50%||18.9|-9.1|
71040839|NCT02725411|141590199|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|14.1|||||TWO_SIDED|95.0|2.9|24.8||||||Week 24: \>=70%||24.8|2.9|
71040840|NCT02725411|141590199|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|10.6|||||TWO_SIDED|95.0|-0.2|21.0||||||Week 24: \>=70%||21.0|-0.2|
71040841|NCT02725411|141590199|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|5.4|||||TWO_SIDED|95.0|-0.7|11.4||||||Week 24: \>=90%||11.4|-0.7|
71040842|NCT02725411|141590199|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|3.2|||||TWO_SIDED|95.0|-2.2|8.5||||||Week 24: \>=90%||8.5|-2.2|
71040843|NCT02725411|141590199|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|17.4|||||TWO_SIDED|95.0|3.1|30.9||||||Week 40: \>=30%||30.9|3.1|
71040844|NCT02725411|141590199|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|-0.5|||||TWO_SIDED|95.0|-14.8|13.7||||||Week 40: \>=30%||13.7|-14.8|
71040845|NCT02725411|141590199|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|17.4|||||TWO_SIDED|95.0|3.0|31.0||||||Week 40: \>=50%||31.0|3.0|
71040846|NCT02725411|141590199|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|5.0|||||TWO_SIDED|95.0|-9.0|18.7||||||Week 40: \>=50%||18.7|-9.0|
71040847|NCT02725411|141590199|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|17.4|||||TWO_SIDED|95.0|4.6|29.4||||||Week 40: \>=70%||29.4|4.6|
71040848|NCT02725411|141590199|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|7.3|||||TWO_SIDED|95.0|-4.5|18.9||||||Week 40: \>=70%||18.9|-4.5|
70996203|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.21||||0.137|TWO_SIDED|95.0|0.94|1.57|||Regression, Logistic|||Week 12, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.57|0.94|0.1370
70996204|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.52||||0.0018|TWO_SIDED|95.0|1.17|1.97|||Regression, Logistic|||Week 12, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.97|1.17|0.0018
70996205|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.36||||0.0342|TWO_SIDED|95.0|1.02|1.81|||Regression, Logistic|||Week 12, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.81|1.02|0.0342
70996206|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.69||||0.0003|TWO_SIDED|95.0|1.27|2.24|||Regression, Logistic|||Week 12, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.24|1.27|0.0003
70996207|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.16||||0.2561|TWO_SIDED|95.0|0.9|1.51|||Regression, Logistic|||Week 12, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.51|0.90|0.2561
70996208|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.17||||0.2358|TWO_SIDED|95.0|0.9|1.51|||Regression, Logistic|||Week 12, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.51|0.90|0.2358
70996209|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.45||||0.004|TWO_SIDED|95.0|1.13|1.87|||Regression, Logistic|||Week 12, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.87|1.13|0.0040
70996210|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.4||||0.0723|TWO_SIDED|95.0|0.97|2.02|||Regression, Logistic|||Week 12, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.02|0.97|0.0723
70996211|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|2.06|||<|0.0001|TWO_SIDED|95.0|1.45|2.92|||Regression, Logistic|||Week 12, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.92|1.45|<.0001
70996212|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0653|TWO_SIDED|95.0|0.98|1.94|||Regression, Logistic|||Week 12, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.94|0.98|0.0653
70996213|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9177|TWO_SIDED|95.0|0.74|1.4|||Regression, Logistic|||Week 12, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.40|0.74|0.9177
70996214|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.49||||0.0088|TWO_SIDED|95.0|1.11|2.01|||Regression, Logistic|||Week 12, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.01|1.11|0.0088
70996215|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.58||||0.1197|TWO_SIDED|95.0|0.89|2.83|||Regression, Logistic|||Week 12, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.83|0.89|0.1197
70996216|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0913|TWO_SIDED|95.0|0.92|2.92|||Regression, Logistic|||Week 12, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.92|0.92|0.0913
70996217|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.25||||0.4317|TWO_SIDED|95.0|0.72|2.19|||Regression, Logistic|||Week 12, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.19|0.72|0.4317
70996218|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.27||||0.3498|TWO_SIDED|95.0|0.77|2.08|||Regression, Logistic|||Week 12, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.08|0.77|0.3498
70996219|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.31||||0.2768|TWO_SIDED|95.0|0.8|2.15|||Regression, Logistic|||Week 12, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.15|0.80|0.2768
70996220|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0101|TWO_SIDED|95.0|1.09|1.92|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.92|1.09|0.0101
70996221|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.5||||0.0054|TWO_SIDED|95.0|1.13|1.99|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.99|1.13|0.0054
70996222|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.08||||0.5493|TWO_SIDED|95.0|0.84|1.39|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.39|0.84|0.5493
70996223|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.34||||0.0269|TWO_SIDED|95.0|1.03|1.74|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.74|1.03|0.0269
70996224|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0144|TWO_SIDED|95.0|1.07|1.8|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.80|1.07|0.0144
70996225|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0846|TWO_SIDED|95.0|0.97|1.7|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.70|0.97|0.0846
70996226|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0101|TWO_SIDED|95.0|1.09|1.91|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.91|1.09|0.0101
71040849|NCT02725411|141590199|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|7.6|||||TWO_SIDED|95.0|1.4|13.5||||||Week 40: \>=90%||13.5|1.4|
70996227|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.25||||0.0848|TWO_SIDED|95.0|0.97|1.62|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.62|0.97|0.0848
70996228|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8732|TWO_SIDED|95.0|0.79|1.32|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.32|0.79|0.8732
70996229|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.15||||0.2734|TWO_SIDED|95.0|0.89|1.48|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.48|0.89|0.2734
70996230|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.21||||0.2839|TWO_SIDED|95.0|0.86|1.7|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.70|0.86|0.2839
70996231|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0238|TWO_SIDED|95.0|1.05|2.07|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.07|1.05|0.0238
70996232|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.11||||0.5212|TWO_SIDED|95.0|0.81|1.53|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.53|0.81|0.5212
70996233|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.09||||0.5954|TWO_SIDED|95.0|0.8|1.48|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.48|0.80|0.5954
70996234|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.33||||0.0638|TWO_SIDED|95.0|0.98|1.79|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.79|0.98|0.0638
70996235|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.38||||0.2661|TWO_SIDED|95.0|0.78|2.44|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.44|0.78|0.2661
70996236|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.24||||0.4717|TWO_SIDED|95.0|0.69|2.21|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.21|0.69|0.4717
70996237|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.17||||0.5798|TWO_SIDED|95.0|0.68|2.0|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.00|0.68|0.5798
70996238|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.18||||0.5027|TWO_SIDED|95.0|0.72|1.95|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.95|0.72|0.5027
70996239|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8165|TWO_SIDED|95.0|0.64|1.77|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.77|0.64|0.8165
70996240|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.18||||0.1996|TWO_SIDED|95.0|0.92|1.52|||Regression, Logistic|||Week 24, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.52|0.92|0.1996
70996241|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0074|TWO_SIDED|95.0|1.1|1.83|||Regression, Logistic|||Week 24, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.83|1.10|0.0074
70996242|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.13||||0.3557|TWO_SIDED|95.0|0.87|1.45|||Regression, Logistic|||Week 24, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.45|0.87|0.3557
71040850|NCT02725411|141590199|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|5.4|||||TWO_SIDED|95.0|-0.1|10.6||||||Week 40: \>=90%||10.6|-0.1|
70996243|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.36||||0.017|TWO_SIDED|95.0|1.06|1.75|||Regression, Logistic|||Week 24, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.75|1.06|0.0170
70996244|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8641|TWO_SIDED|95.0|0.76|1.38|||Regression, Logistic|||Week 24, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.38|0.76|0.8641
70996245|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.22||||0.1768|TWO_SIDED|95.0|0.91|1.62|||Regression, Logistic|||Week 24, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.62|0.91|0.1768
70996246|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|0.93||||0.7696|TWO_SIDED|95.0|0.55|1.55|||Regression, Logistic|||Week 24, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.55|0.55|0.7696
70996247|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.09||||0.7433|TWO_SIDED|95.0|0.66|1.78|||Regression, Logistic|||Week 24, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.78|0.66|0.7433
70996248|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0562|TWO_SIDED|95.0|0.99|1.65|||Regression, Logistic|||Week 32, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.65|0.99|0.0562
70996249|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.33||||0.0274|TWO_SIDED|95.0|1.03|1.71|||Regression, Logistic|||Week 32, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.71|1.03|0.0274
71040851|NCT02725411|141590199|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|12.0|||||TWO_SIDED|95.0|-2.4|25.8||||||Week 56: \>=30%||25.8|-2.4|
71040852|NCT02725411|141590199|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|-3.8|||||TWO_SIDED|95.0|-17.9|10.5||||||Week 56: \>=30%||10.5|-17.9|
70996250|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.22||||0.1206|TWO_SIDED|95.0|0.95|1.58|||Regression, Logistic|||Week 32, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.58|0.95|0.1206
70996251|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.31||||0.0365|TWO_SIDED|95.0|1.02|1.69|||Regression, Logistic|||Week 32, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.69|1.02|0.0365
70996252|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0964|TWO_SIDED|95.0|0.96|1.71|||Regression, Logistic|||Week 32, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.71|0.96|0.0964
70996253|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.19||||0.2515|TWO_SIDED|95.0|0.89|1.59|||Regression, Logistic|||Week 32, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.59|0.89|0.2515
70996254|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8122|TWO_SIDED|95.0|0.66|1.71|||Regression, Logistic|||Week 32, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.71|0.66|0.8122
70996255|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.36||||0.1848|TWO_SIDED|95.0|0.86|2.13|||Regression, Logistic|||Week 32, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.13|0.86|0.1848
70996256|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.16||||0.2622|TWO_SIDED|95.0|0.9|1.49|||Regression, Logistic|||Week 40, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.49|0.90|0.2622
70996257|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.2||||0.1579|TWO_SIDED|95.0|0.93|1.54|||Regression, Logistic|||Week 40, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.54|0.93|0.1579
70996258|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.15||||0.2773|TWO_SIDED|95.0|0.89|1.49|||Regression, Logistic|||Week 40, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.49|0.89|0.2773
70996259|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.24||||0.1032|TWO_SIDED|95.0|0.96|1.59|||Regression, Logistic|||Week 40, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.59|0.96|0.1032
70996260|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.12||||0.4418|TWO_SIDED|95.0|0.84|1.5|||Regression, Logistic|||Week 40, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.50|0.84|0.4418
70996261|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.23||||0.1608|TWO_SIDED|95.0|0.92|1.63|||Regression, Logistic|||Week 40, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.63|0.92|0.1608
70996262|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.29||||0.2628|TWO_SIDED|95.0|0.83|2.02|||Regression, Logistic|||Week 40, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.02|0.83|0.2628
70996263|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.55||||0.0447|TWO_SIDED|95.0|1.01|2.39|||Regression, Logistic|||Week 40, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.39|1.01|0.0447
70996264|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.16||||0.256|TWO_SIDED|95.0|0.9|1.49|||Regression, Logistic|||Week 48, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.49|0.90|0.2560
70996265|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.19||||0.1741|TWO_SIDED|95.0|0.93|1.53|||Regression, Logistic|||Week 48, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.53|0.93|0.1741
70996266|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.2||||0.1647|TWO_SIDED|95.0|0.93|1.55|||Regression, Logistic|||Week 48, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.55|0.93|0.1647
70996267|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0619|TWO_SIDED|95.0|0.99|1.65|||Regression, Logistic|||Week 48, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.65|0.99|0.0619
70996268|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.21||||0.2025|TWO_SIDED|95.0|0.9|1.61|||Regression, Logistic|||Week 48, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.61|0.90|0.2025
70996269|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.18||||0.2601|TWO_SIDED|95.0|0.88|1.58|||Regression, Logistic|||Week 48, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.58|0.88|0.2601
70996270|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.14||||0.5635|TWO_SIDED|95.0|0.73|1.77|||Regression, Logistic|||Week 48, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.77|0.73|0.5635
70996271|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.38||||0.1338|TWO_SIDED|95.0|0.91|2.11|||Regression, Logistic|||Week 48, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.11|0.91|0.1338
70996272|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.17||||0.2137|TWO_SIDED|95.0|0.91|1.51|||Regression, Logistic|||Week 56, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.51|0.91|0.2137
70996273|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.33||||0.0256|TWO_SIDED|95.0|1.04|1.72|||Regression, Logistic|||Week 56, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.72|1.04|0.0256
70996274|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.13||||0.3531|TWO_SIDED|95.0|0.87|1.46|||Regression, Logistic|||Week 56, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.46|0.87|0.3531
70996275|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.31||||0.0358|TWO_SIDED|95.0|1.02|1.7|||Regression, Logistic|||Week 56, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.70|1.02|0.0358
70996276|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.22||||0.184|TWO_SIDED|95.0|0.91|1.62|||Regression, Logistic|||Week 56, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.62|0.91|0.1840
70996277|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.25||||0.125|TWO_SIDED|95.0|0.94|1.67|||Regression, Logistic|||Week 56, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.67|0.94|0.1250
70996278|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|0.95||||0.8266|TWO_SIDED|95.0|0.61|1.48|||Regression, Logistic|||Week 56, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.48|0.61|0.8266
70996279|NCT02528253|141501279|SUPERIORITY||Odds Ratio (OR)|1.13||||0.5673|TWO_SIDED|95.0|0.74|1.72|||Regression, Logistic|||Week 56, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.72|0.74|0.5673
71040853|NCT02725411|141590199|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|12.0|||||TWO_SIDED|95.0|-2.5|25.9||||||Week 56: \>=50%||25.9|-2.5|
71040854|NCT02725411|141590199|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|-2.6|||||TWO_SIDED|95.0|-16.5|11.4||||||Week 56: \>=50%||11.4|-16.5|
71040855|NCT02725411|141590199|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|18.5|||||TWO_SIDED|95.0|5.6|30.5||||||Week 56: \>=70%||30.5|5.6|
71040856|NCT02725411|141590199|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|8.4|||||TWO_SIDED|95.0|-3.6|20.0||||||Week 56: \>=70%||20.0|-3.6|
71040857|NCT02725411|141590199|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|8.7|||||TWO_SIDED|95.0|1.6|15.4||||||Week 56: \>=90%||15.4|1.6|
70996280|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.53||||0.0076|TWO_SIDED|95.0|1.12|2.08|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.08|1.12|0.0076
70996281|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.98|||<|0.0001|TWO_SIDED|95.0|1.46|2.69|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.69|1.46|<.0001
70996282|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.31||||0.07|TWO_SIDED|95.0|0.98|1.74|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.74|0.98|0.0700
70996283|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.17||||0.2655|TWO_SIDED|95.0|0.89|1.54|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.54|0.89|0.2655
70996284|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.52||||0.0022|TWO_SIDED|95.0|1.16|1.98|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.98|1.16|0.0022
70996285|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0125|TWO_SIDED|95.0|1.11|2.35|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.35|1.11|0.0125
70996286|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.75||||0.0032|TWO_SIDED|95.0|1.21|2.54|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.54|1.21|0.0032
71040858|NCT02725411|141590199|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|3.2|||||TWO_SIDED|95.0|-2.2|8.5||||||Week 56: \>=90%||8.5|-2.2|
70996287|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.3||||0.1528|TWO_SIDED|95.0|0.91|1.85|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.85|0.91|0.1528
70996288|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.24||||0.1863|TWO_SIDED|95.0|0.9|1.72|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.72|0.90|0.1863
70996289|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.35||||0.0667|TWO_SIDED|95.0|0.98|1.86|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.86|0.98|0.0667
70996290|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0101|TWO_SIDED|95.0|1.18|3.39|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.39|1.18|0.0101
71040859|NCT02725411|141590215|OTHER|No formal hypotheses were tested in the study.|Difference in proportion|0.0|||||TWO_SIDED|95.0|-4.1|4.1||||||95% CI of proportion is the Agresti-Coull confidence limit.||4.1|-4.1|
71040860|NCT02725411|141590215|OTHER|No formal hypotheses were tested in the study.|Difference in proportion|3.2|||||TWO_SIDED|95.0|-2.2|8.5||||||95% CI of proportion is the Agresti-Coull confidence limit.||8.5|-2.2|
71040861|NCT02911935|141590236|SUPERIORITY||Hazard Ratio (HR)|1.49||||0.08|TWO_SIDED|95.0|0.95|2.34||unadjusted P-value. The threshold for statistical significance was p = 0.05|Log Rank|||The primary analysis tested the statistical null hypothesis of equal recurrent wheeze rates between the azithromycin and placebo groups.||2.34|0.95|0.08
71040862|NCT02911935|141590236|SUPERIORITY||Hazard Ratio (HR)|1.45||||0.11|TWO_SIDED|95.0|0.92|2.29||p-value is adjusted for race, parental history of asthma, ever exposed to smoke and ever exposed to pets. The threshold for statistical significance was p = 0.05|Regression, Cox|||||2.29|0.92|0.11
70996291|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.91||||0.0162|TWO_SIDED|95.0|1.13|3.25|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.25|1.13|0.0162
70996292|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.17||||0.5599|TWO_SIDED|95.0|0.69|1.99|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.99|0.69|0.5599
70996293|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.71||||0.0202|TWO_SIDED|95.0|1.09|2.68|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.68|1.09|0.0202
70996294|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0335|TWO_SIDED|95.0|1.04|2.57|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.57|1.04|0.0335
70996295|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|2.53||||0.0416|TWO_SIDED|95.0|1.04|6.17|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||6.17|1.04|0.0416
70996296|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|3.24||||0.0075|TWO_SIDED|95.0|1.37|7.69|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||7.69|1.37|0.0075
70996297|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.33||||0.5374|TWO_SIDED|95.0|0.53|3.34|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.34|0.53|0.5374
70996298|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.89||||0.082|TWO_SIDED|95.0|0.92|3.89|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.89|0.92|0.0820
70996299|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0108|TWO_SIDED|95.0|1.23|4.81|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||4.81|1.23|0.0108
70996300|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0006|TWO_SIDED|95.0|1.24|2.2|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.20|1.24|0.0006
70996301|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.95|||<|0.0001|TWO_SIDED|95.0|1.47|2.59|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.59|1.47|<.0001
70996302|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.25||||0.0963|TWO_SIDED|95.0|0.96|1.63|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.63|0.96|0.0963
70996303|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.32||||0.0332|TWO_SIDED|95.0|1.02|1.71|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.71|1.02|0.0332
70996304|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0007|TWO_SIDED|95.0|1.21|2.01|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.01|1.21|0.0007
71040863|NCT02911935|141590237|SUPERIORITY||Hazard Ratio (HR)|1.95||||0.12|TWO_SIDED|95.0|0.83|4.61||Unadjusted. The threshold for statistical significance was p = 0.05|Log Rank|||||4.61|0.83|0.12
70996305|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0001|TWO_SIDED|95.0|1.37|2.64|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.64|1.37|0.0001
70996306|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.6|3.05|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.05|1.60|<.0001
70996307|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.43||||0.0235|TWO_SIDED|95.0|1.05|1.95|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.95|1.05|0.0235
70996308|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.33||||0.0459|TWO_SIDED|95.0|1.01|1.76|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.76|1.01|0.0459
70996309|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.54||||0.002|TWO_SIDED|95.0|1.17|2.04|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.04|1.17|0.0020
70996310|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.93||||0.0019|TWO_SIDED|95.0|1.27|2.91|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.91|1.27|0.0019
70996311|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|2.42|||<|0.0001|TWO_SIDED|95.0|1.62|3.62|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.62|1.62|<.0001
70996312|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.09||||0.6765|TWO_SIDED|95.0|0.72|1.65|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.65|0.72|0.6765
70996313|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0022|TWO_SIDED|95.0|1.23|2.54|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.54|1.23|0.0022
71040864|NCT02911935|141590238|SUPERIORITY||Rate Ratio|1.18||||0.31|TWO_SIDED|95.0|0.86|1.62||Unadjusted. The threshold for statistical significance was p = 0.05|Negative Binomial Regression Analysis|||||1.62|0.86|0.31
70996314|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.56|3.15|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.15|1.56|<.0001
70996315|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.98||||0.027|TWO_SIDED|95.0|1.08|3.63|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.63|1.08|0.0270
70996316|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|2.43||||0.003|TWO_SIDED|95.0|1.35|4.38|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||4.38|1.35|0.0030
70996317|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|0.74||||0.377|TWO_SIDED|95.0|0.38|1.44|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.44|0.38|0.3770
70996318|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|2.68||||0.0009|TWO_SIDED|95.0|1.49|4.79|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||4.79|1.49|0.0009
70996319|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|3.29|||<|0.0001|TWO_SIDED|95.0|1.87|5.78|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||5.78|1.87|<.0001
70996320|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.59||||0.0011|TWO_SIDED|95.0|1.2|2.1|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.10|1.20|0.0011
70996321|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.87|||<|0.0001|TWO_SIDED|95.0|1.41|2.47|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.47|1.41|<.0001
70996322|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.33||||0.0273|TWO_SIDED|95.0|1.03|1.72|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.72|1.03|0.0273
70996323|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.19||||0.1736|TWO_SIDED|95.0|0.93|1.54|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.54|0.93|0.1736
70996324|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.4||||0.0092|TWO_SIDED|95.0|1.09|1.81|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.81|1.09|0.0092
70996325|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0015|TWO_SIDED|95.0|1.2|2.2|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.20|1.20|0.0015
70996326|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.95|||<|0.0001|TWO_SIDED|95.0|1.45|2.63|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.63|1.45|<.0001
70996327|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.41||||0.0164|TWO_SIDED|95.0|1.06|1.86|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.86|1.06|0.0164
70996328|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.16||||0.2857|TWO_SIDED|95.0|0.89|1.51|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.51|0.89|0.2857
70996329|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0149|TWO_SIDED|95.0|1.07|1.8|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.80|1.07|0.0149
70996330|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|2.08||||0.0001|TWO_SIDED|95.0|1.43|3.02|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.02|1.43|0.0001
70996331|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|2.27|||<|0.0001|TWO_SIDED|95.0|1.57|3.28|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.28|1.57|<.0001
70996332|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.34||||0.118|TWO_SIDED|95.0|0.93|1.92|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.92|0.93|0.1180
70996333|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0062|TWO_SIDED|95.0|1.13|2.14|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.14|1.13|0.0062
70996334|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0009|TWO_SIDED|95.0|1.24|2.32|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.32|1.24|0.0009
70996335|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|2.69||||0.0003|TWO_SIDED|95.0|1.56|4.61|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||4.61|1.56|0.0003
70996336|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|3.1|||<|0.0001|TWO_SIDED|95.0|1.82|5.28|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||5.28|1.82|<.0001
70996337|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.33||||0.312|TWO_SIDED|95.0|0.76|2.32|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.32|0.76|0.3120
70996338|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|2.02||||0.0019|TWO_SIDED|95.0|1.3|3.14|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.14|1.30|0.0019
70996339|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0001|TWO_SIDED|95.0|1.52|3.59|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.59|1.52|0.0001
71040865|NCT02911935|141590239|SUPERIORITY||Rate Ratio|1.22||||0.57|TWO_SIDED|95.0|0.6|2.48||Unadjusted. The threshold for statistical significance was p = 0.05|Negative Binomial Regression Analysis|||||2.48|0.6|0.57
71040866|NCT02911935|141590240|SUPERIORITY||Rate Ratio|1.34||||0.38|TWO_SIDED|95.0|0.7|2.57||unadjusted P-value. The threshold for statistical significance was p = 0.05|Negative Binomial Regression Analysis|||||2.57|0.70|0.38
71040867|NCT02911935|141590241|SUPERIORITY||Rate Ratio|0.92||||0.56|TWO_SIDED|95.0|0.7|1.22||Unadjusted. The threshold for statistical significance was p = 0.05|Negative Binomial Regression Analysis|||||1.22|0.7|0.56
71040868|NCT04979858|141590276|OTHER|The statistical analysis involved the use of a single-factor ANOVA test to assess the importance of the various factors associated with the design of the Focal Mask (the Treatment) that would impact its performance in reducing the spread of COVID-19, which is caused by the SARS-CoV-2 virus. The Bonferroni t-test was conducted post hoc to assess the statistical significance of the various factors.|||||<|0.01|||||||ANOVA|||||||<0.01
71040869|NCT04974580|141590313|SUPERIORITY||Odds Ratio (OR)|1.3||||0.14|TWO_SIDED|95.0|0.91|1.84||A priori threshold was 0.10|Regression, Logistic||Reported OR is NRT receipt vs. not, so values \>1 indicate higher odds of abstinence among those receiving NRT.|Comparison of NRT vs. no-NRT in model adjusted for receipt of digital component||1.84|0.91|0.14
71040870|NCT04974580|141590313|SUPERIORITY||Odds Ratio (OR)|1.04||||0.84|TWO_SIDED|95.0|0.73|1.47||A priori threshold was 0.10|Regression, Logistic||Reported OR is Digital receipt vs. not, so values \>1 indicate higher odds of abstinence among those receiving the Digital component.|Comparison of Digital vs. no Digital in model adjusted for receipt of NRT component||1.47|0.73|0.84
71040871|NCT00462839|141590318|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||Post-hoc comparison of 500ml, 1000ml and 2000ml volumes were greater in the non-calibrated drape first group. Post-hoc comparisons made using Bonferroni correct t-test for 8 comparisons.|ANOVA|||Repeated measures ANOVA comparing all levels of blood estimation (P=0.0002). Post-hoc comparisons using Bonferroni corrects t-tests.||||<0.05
71040872|NCT00462839|141590319|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||Chi-squared, Corrected|||||||0.76
71040873|NCT00462839|141590320|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||Chi-squared, Corrected|||||||0.72
71040874|NCT00462839|141590321|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Chi-squared, Corrected|||||||0.89
70996340|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0064|TWO_SIDED|95.0|1.12|1.95|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.95|1.12|0.0064
70996341|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0001|TWO_SIDED|95.0|1.32|2.31|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.31|1.32|0.0001
70996342|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.15||||0.2757|TWO_SIDED|95.0|0.89|1.48|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.48|0.89|0.2757
70996343|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0575|TWO_SIDED|95.0|0.99|1.65|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.65|0.99|0.0575
71040875|NCT03919695|141590333|SUPERIORITY||Odds Ratio (OR)|0.29||||0.002|TWO_SIDED|95.0|0.11|0.73|||GEE model specifying a logistic distribu||time x arm effect for the comparison at 6-month follow-up|Generalized Estimating Equations (GEE) model specifying a logistic distribution examining the time x arm interaction||.73|.11|.002
71040876|NCT02063217|141590345|SUPERIORITY|Mixed linear models|Mean Difference (Net)|17.0||||0.07|TWO_SIDED|||||Bonferroni correction was used for multiple comparisons.|Mixed Models Analysis||Mean (standard error), units = %. 17(7.2) increase in overnight amyloid-beta 40 concentrations over waking baseline between the sleep deprivation group and controls.|Mixed linear modeling of change in overnight amyloid beta concentrations from waking baseline between 01:00 and 11:00. Data provided for amyloid beta-40.||||0.07
71040877|NCT02063217|141590345|SUPERIORITY|Mixed linear models|Mean Difference (Net)|7.0||||1|TWO_SIDED|||||Bonferroni correction was used for multiple comparisons.|Mixed Models Analysis||Mean= 7%, standard error = 7.6%. 7% increase in overnight amyloid beta 40 concentrations over the waking baseline between the sleep induction group and control group.|Mixed linear modeling of change in overnight amyloid beta concentrations from waking baseline between 01:00 and 11:00. Data provided for amyloid beta-40.||||1.0
71040878|NCT02212457|141590351|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded when, at 1 month after the second meningococcal vaccination (Visit Month 3), the lower limit of the two-sided 95% confidence interval for the between-group ratios of GMTs (ABCWY\_0\_2 versus rMenB\_0\_2) was greater than 0.5 for each of the four serogroup B test strains.|Geometric Mean Ratio|0.74|||||TWO_SIDED|95.0|0.53|1.02|||ANCOVA|||Non-inferiority response against N. meningitidis serogroup B test strain M14459 of the MenABCWY vaccine to that of the Bexsero vaccine, administered according to 0, 2 month schedule.||1.02|0.53|
70996344|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.52||||0.0015|TWO_SIDED|95.0|1.17|1.96|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.96|1.17|0.0015
70996345|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0007|TWO_SIDED|95.0|1.23|2.16|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.16|1.23|0.0007
70996346|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0001|TWO_SIDED|95.0|1.31|2.31|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.31|1.31|0.0001
70996347|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0124|TWO_SIDED|95.0|1.07|1.79|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.79|1.07|0.0124
70996348|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0025|TWO_SIDED|95.0|1.15|1.91|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.91|1.15|0.0025
70996349|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.82||||0.0002|TWO_SIDED|95.0|1.33|2.51|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.51|1.33|0.0002
70996350|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|2.03|||<|0.0001|TWO_SIDED|95.0|1.48|2.79|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.79|1.48|<.0001
70996351|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.09||||0.5701|TWO_SIDED|95.0|0.8|1.49|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.49|0.80|0.5701
70996352|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.67||||0.0004|TWO_SIDED|95.0|1.26|2.22|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.22|1.26|0.0004
70996353|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.86|||<|0.0001|TWO_SIDED|95.0|1.4|2.46|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.46|1.40|<.0001
70996354|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|2.07||||0.0008|TWO_SIDED|95.0|1.35|3.17|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.17|1.35|0.0008
70996355|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.84||||0.0059|TWO_SIDED|95.0|1.19|2.83|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.83|1.19|0.0059
70996356|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|0.94||||0.7741|TWO_SIDED|95.0|0.6|1.46|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.46|0.60|0.7741
70996357|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.5|3.25|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.25|1.50|<.0001
70996358|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.96||||0.0008|TWO_SIDED|95.0|1.32|2.9|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.90|1.32|0.0008
70996359|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.25||||0.089|TWO_SIDED|95.0|0.97|1.6|||Regression, Logistic|||Week 24, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.60|0.97|0.0890
70996360|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0067|TWO_SIDED|95.0|1.1|1.83|||Regression, Logistic|||Week 24, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.83|1.10|0.0067
70996361|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.43||||0.0072|TWO_SIDED|95.0|1.1|1.85|||Regression, Logistic|||Week 24, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.85|1.10|0.0072
70996362|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.59||||0.0004|TWO_SIDED|95.0|1.23|2.06|||Regression, Logistic|||Week 24, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.06|1.23|0.0004
70996363|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0013|TWO_SIDED|95.0|1.2|2.15|||Regression, Logistic|||Week 24, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.15|1.20|0.0013
70996364|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.79|||<|0.0001|TWO_SIDED|95.0|1.34|2.39|||Regression, Logistic|||Week 24, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.39|1.34|<.0001
70996365|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|2.23|||<|0.0001|TWO_SIDED|95.0|1.51|3.3|||Regression, Logistic|||Week 24, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.30|1.51|<.0001
70996366|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|2.53|||<|0.0001|TWO_SIDED|95.0|1.72|3.71|||Regression, Logistic|||Week 24, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.71|1.72|<.0001
70996367|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.26||||0.0732|TWO_SIDED|95.0|0.98|1.62|||Regression, Logistic|||Week 32, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.62|0.98|0.0732
70996368|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.3||||0.0399|TWO_SIDED|95.0|1.01|1.68|||Regression, Logistic|||Week 32, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.68|1.01|0.0399
70996369|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.29||||0.0536|TWO_SIDED|95.0|1.0|1.67|||Regression, Logistic|||Week 32, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.67|1.00|0.0536
70996370|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0043|TWO_SIDED|95.0|1.12|1.88|||Regression, Logistic|||Week 32, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.88|1.12|0.0043
70996371|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.43||||0.0143|TWO_SIDED|95.0|1.07|1.91|||Regression, Logistic|||Week 32, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.91|1.07|0.0143
70996372|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0007|TWO_SIDED|95.0|1.23|2.16|||Regression, Logistic|||Week 32, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.16|1.23|0.0007
70996373|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.67||||0.005|TWO_SIDED|95.0|1.17|2.38|||Regression, Logistic|||Week 32, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.38|1.17|0.0050
70996374|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0043|TWO_SIDED|95.0|1.18|2.4|||Regression, Logistic|||Week 32, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.40|1.18|0.0043
70996375|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.15||||0.2777|TWO_SIDED|95.0|0.89|1.48|||Regression, Logistic|||Week 40, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.48|0.89|0.2777
70996376|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.32||||0.0326|TWO_SIDED|95.0|1.02|1.7|||Regression, Logistic|||Week 40, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.70|1.02|0.0326
70996377|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.19||||0.1823|TWO_SIDED|95.0|0.92|1.55|||Regression, Logistic|||Week 40, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.55|0.92|0.1823
70996378|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.32||||0.035|TWO_SIDED|95.0|1.02|1.71|||Regression, Logistic|||Week 40, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.71|1.02|0.0350
70996379|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0164|TWO_SIDED|95.0|1.07|1.88|||Regression, Logistic|||Week 40, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.88|1.07|0.0164
70996380|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0257|TWO_SIDED|95.0|1.04|1.84|||Regression, Logistic|||Week 40, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.84|1.04|0.0257
70996381|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.64||||0.007|TWO_SIDED|95.0|1.14|2.35|||Regression, Logistic|||Week 40, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.35|1.14|0.0070
70996382|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.62||||0.0085|TWO_SIDED|95.0|1.13|2.32|||Regression, Logistic|||Week 40, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.32|1.13|0.0085
70996383|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.09||||0.4925|TWO_SIDED|95.0|0.85|1.41|||Regression, Logistic|||Week 48, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.41|0.85|0.4925
70996384|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.2||||0.1534|TWO_SIDED|95.0|0.93|1.55|||Regression, Logistic|||Week 48, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.55|0.93|0.1534
70996385|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.23||||0.1202|TWO_SIDED|95.0|0.95|1.6|||Regression, Logistic|||Week 48, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.60|0.95|0.1202
70996386|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.23||||0.1222|TWO_SIDED|95.0|0.95|1.6|||Regression, Logistic|||Week 48, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.60|0.95|0.1222
70996387|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0179|TWO_SIDED|95.0|1.06|1.9|||Regression, Logistic|||Week 48, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.90|1.06|0.0179
70996388|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.49||||0.0065|TWO_SIDED|95.0|1.12|1.99|||Regression, Logistic|||Week 48, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.99|1.12|0.0065
70996389|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.53||||0.0223|TWO_SIDED|95.0|1.06|2.2|||Regression, Logistic|||Week 48, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.20|1.06|0.0223
70996390|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0045|TWO_SIDED|95.0|1.17|2.4|||Regression, Logistic|||Week 48, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.40|1.17|0.0045
70996391|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9385|TWO_SIDED|95.0|0.77|1.28|||Regression, Logistic|||Week 56, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.28|0.77|0.9385
70996392|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.23||||0.1093|TWO_SIDED|95.0|0.95|1.59|||Regression, Logistic|||Week 56, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.59|0.95|0.1093
70996393|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.21||||0.1631|TWO_SIDED|95.0|0.93|1.57|||Regression, Logistic|||Week 56, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.57|0.93|0.1631
70996394|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.34||||0.0285|TWO_SIDED|95.0|1.03|1.74|||Regression, Logistic|||Week 56, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.74|1.03|0.0285
70996395|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.36||||0.0389|TWO_SIDED|95.0|1.02|1.81|||Regression, Logistic|||Week 56, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.81|1.02|0.0389
70996396|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.39||||0.024|TWO_SIDED|95.0|1.04|1.86|||Regression, Logistic|||Week 56, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.86|1.04|0.0240
70996397|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0063|TWO_SIDED|95.0|1.15|2.34|||Regression, Logistic|||Week 56, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.34|1.15|0.0063
70996398|NCT02528253|141501280|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0021|TWO_SIDED|95.0|1.22|2.47|||Regression, Logistic|||Week 56, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.47|1.22|0.0021
70996399|NCT02528253|141501282|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.13||0.0003|TWO_SIDED|95.0|-0.75|-0.22|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.22|-0.75|0.0003
70996400|NCT02528253|141501282|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.85|-0.33|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.33|-0.85|<.0001
70996401|NCT02528253|141501282|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.12||0.0615|TWO_SIDED|95.0|-0.47|0.01|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.01|-0.47|0.0615
70996402|NCT02528253|141501282|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.12||0.0356|TWO_SIDED|95.0|-0.5|-0.02|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.50|0.0356
70996403|NCT02528253|141501282|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.12||0.0032|TWO_SIDED|95.0|-0.6|-0.12|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.12|-0.60|0.0032
70996404|NCT02528253|141501282|SUPERIORITY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.16||0.0003|TWO_SIDED|95.0|-0.88|-0.27|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.27|-0.88|0.0003
70996405|NCT02528253|141501282|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.08|-0.46|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.46|-1.08|<.0001
70996406|NCT02528253|141501282|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.15||0.0844|TWO_SIDED|95.0|-0.54|0.03|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.54|0.0844
70996407|NCT02528253|141501282|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.14||0.0258|TWO_SIDED|95.0|-0.6|-0.04|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-0.60|0.0258
70996408|NCT02528253|141501282|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.15||0.0004|TWO_SIDED|95.0|-0.8|-0.23|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.23|-0.80|0.0004
70996409|NCT02528253|141501282|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.17||0.0079|TWO_SIDED|95.0|-0.78|-0.12|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.12|-0.78|0.0079
70996410|NCT02528253|141501282|SUPERIORITY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.08|-0.41|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.41|-1.08|<.0001
70996411|NCT02528253|141501282|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.16||0.0977|TWO_SIDED|95.0|-0.57|0.05|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.57|0.0977
70996412|NCT02528253|141501282|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.15||0.215|TWO_SIDED|95.0|-0.5|0.11|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.11|-0.50|0.2150
70996413|NCT02528253|141501282|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.15||0.0016|TWO_SIDED|95.0|-0.79|-0.18|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.18|-0.79|0.0016
70996414|NCT02528253|141501282|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.19||0.0058|TWO_SIDED|95.0|-0.88|-0.15|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.15|-0.88|0.0058
70996415|NCT02528253|141501282|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.19||0.0038|TWO_SIDED|95.0|-0.91|-0.18|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.18|-0.91|0.0038
70996416|NCT02528253|141501282|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.17||0.1707|TWO_SIDED|95.0|-0.58|0.1|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.58|0.1707
70996417|NCT02528253|141501282|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.17||0.1083|TWO_SIDED|95.0|-0.62|0.06|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.06|-0.62|0.1083
70996418|NCT02528253|141501282|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.17||0.0734|TWO_SIDED|95.0|-0.64|0.03|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.64|0.0734
70996419|NCT02528253|141501282|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.21||0.4603|TWO_SIDED|95.0|-0.56|0.25|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.25|-0.56|0.4603
70996420|NCT02528253|141501282|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.2||0.0799|TWO_SIDED|95.0|-0.74|0.04|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-0.74|0.0799
70996421|NCT02528253|141501282|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.21||0.2339|TWO_SIDED|95.0|-0.66|0.16|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.16|-0.66|0.2339
70996422|NCT02528253|141501282|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.21||0.1199|TWO_SIDED|95.0|-0.73|0.08|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.08|-0.73|0.1199
70996423|NCT02528253|141501282|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.21||0.384|TWO_SIDED|95.0|-0.6|0.23|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.23|-0.60|0.3840
70996424|NCT02528253|141501282|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.21||0.2|TWO_SIDED|95.0|-0.68|0.14|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.14|-0.68|0.2000
70996425|NCT02528253|141501282|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.22||0.2997|TWO_SIDED|95.0|-0.65|0.2|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.20|-0.65|0.2997
70996426|NCT02528253|141501282|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.21||0.1778|TWO_SIDED|95.0|-0.71|0.13|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.71|0.1778
70996427|NCT02528253|141501282|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.22||0.3438|TWO_SIDED|95.0|-0.65|0.23|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.23|-0.65|0.3438
70996428|NCT02528253|141501282|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.22||0.1876|TWO_SIDED|95.0|-0.71|0.14|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.14|-0.71|0.1876
70996429|NCT02528253|141501284|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.13||0.0002|TWO_SIDED|95.0|-0.72|-0.22|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.22|-0.72|0.0002
70996430|NCT02528253|141501284|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.79|-0.29|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.29|-0.79|<.0001
70996431|NCT02528253|141501284|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.12||0.0193|TWO_SIDED|95.0|-0.5|-0.04|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-0.50|0.0193
70996432|NCT02528253|141501284|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.0845|TWO_SIDED|95.0|-0.42|0.03|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.42|0.0845
70996433|NCT02528253|141501284|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.12||0.0212|TWO_SIDED|95.0|-0.49|-0.04|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-0.49|0.0212
70996434|NCT02528253|141501284|SUPERIORITY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.15||0.0003|TWO_SIDED|95.0|-0.81|-0.24|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.24|-0.81|0.0003
70996435|NCT02528253|141501284|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.99|-0.41|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.41|-0.99|<.0001
71040879|NCT02212457|141590351|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded when, at 1 month after the second meningococcal vaccination (Visit Month 3), the lower limit of the two-sided 95% confidence interval for the between-group ratios of GMTs (ABCWY\_0\_2 versus rMenB\_0\_2) was greater than 0.5 for each of the four serogroup B test strains.|Geometric Mean Ratio|0.71|||||TWO_SIDED|95.0|0.54|0.94|||ANCOVA|||Non-inferiority response against N. meningitidis serogroup B test strain M07-0241084 of the MenABCWY vaccine to that of the Bexsero vaccine, administered according to 0, 2 month schedule.||0.94|0.54|
71040880|NCT02212457|141590351|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded when, at 1 month after the second meningococcal vaccination (Visit Month 3), the lower limit of the two-sided 95% confidence interval for the between-group ratios of GMTs (ABCWY\_0\_2 versus rMenB\_0\_2) was greater than 0.5 for each of the four serogroup B test strains.|Geometric Mean Ratio|0.66|||||TWO_SIDED|95.0|0.51|0.85|||ANCOVA|||Non-inferiority response against N. meningitidis serogroup B test strain 96217 of the MenABCWY vaccine to that of the Bexsero vaccine, administered according to 0, 2 month schedule.||0.85|0.51|
70923763|NCT04521478|141339291|OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.2347|TWO_SIDED|90.0|-0.1|0.6|||Mixed Models Analysis||Difference = (adjusted mean 125 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||0.6|-0.1|0.2347
71100161|NCT03992872|141708996|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|3.11||||0.0019|TWO_SIDED|95.0|1.55|6.23|||ANOVA|P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 8: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||6.23|1.55|0.0019
71100162|NCT03992872|141708996|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|0.88||||0.6223|TWO_SIDED|95.0|0.54|1.46|||ANOVA|P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 22: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||1.46|0.54|0.6223
71100163|NCT03992872|141708996|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|0.88||||0.6444|TWO_SIDED|95.0|0.5|1.55||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 29: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||1.55|0.50|0.6444
70996436|NCT02528253|141501284|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.14||0.079|TWO_SIDED|95.0|-0.5|0.03|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.50|0.0790
70996437|NCT02528253|141501284|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.14||0.0336|TWO_SIDED|95.0|-0.55|-0.02|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.55|0.0336
70996438|NCT02528253|141501284|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.14||0.0008|TWO_SIDED|95.0|-0.73|-0.19|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.19|-0.73|0.0008
70996439|NCT02528253|141501284|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.16||0.0034|TWO_SIDED|95.0|-0.77|-0.15|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.15|-0.77|0.0034
70996440|NCT02528253|141501284|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.01|-0.39|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.39|-1.01|<.0001
70996441|NCT02528253|141501284|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.15||0.0361|TWO_SIDED|95.0|-0.59|-0.02|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.59|0.0361
70996442|NCT02528253|141501284|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.15||0.2786|TWO_SIDED|95.0|-0.44|0.13|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.44|0.2786
70996443|NCT02528253|141501284|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.0058|TWO_SIDED|95.0|-0.68|-0.11|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.68|0.0058
71100164|NCT03992872|141708996|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|0.89||||0.6198|TWO_SIDED|95.0|0.57|1.41||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 57: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||1.41|0.57|0.6198
70996444|NCT02528253|141501284|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.18||0.0365|TWO_SIDED|95.0|-0.71|-0.02|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.71|0.0365
71100165|NCT03992872|141708996|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|0.89||||0.6451|TWO_SIDED|95.0|0.55|1.45||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 182: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||1.45|0.55|0.6451
71100166|NCT03992872|141708997|SUPERIORITY|||||||0.0211|||||||Fisher Exact|"Day 8~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||0.0211
71100167|NCT03992872|141708997|SUPERIORITY|||||||1|||||||Fisher Exact|"Day 29.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||1.0000
71100168|NCT03992872|141708997|SUPERIORITY|||||||1|||||||Fisher Exact|"Day 57.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||1.0000
71100169|NCT03992872|141708997|SUPERIORITY|||||||0.1124|||||||Fisher Exact|"Day 182.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||0.1124
71100170|NCT03992872|141708998|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 1 : Subjects with Titer \>=40"||||>0.9999
70996445|NCT02528253|141501284|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.18||0.0092|TWO_SIDED|95.0|-0.8|-0.11|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.80|0.0092
70996446|NCT02528253|141501284|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.16||0.2923|TWO_SIDED|95.0|-0.49|0.15|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.15|-0.49|0.2923
70996447|NCT02528253|141501284|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.2231|TWO_SIDED|95.0|-0.51|0.12|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.12|-0.51|0.2231
71100171|NCT03992872|141708998|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point~Day 1: Subjects with Titer \>=160"||||>0.9999
71100172|NCT03992872|141708998|SUPERIORITY|||||||1|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 1: Subjects with Titer \>=640"||||1.0000
71100173|NCT03992872|141708998|SUPERIORITY|||||||0.0257|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 8 : Subjects with Titer \>=40"||||0.0257
71100174|NCT03992872|141708998|SUPERIORITY|||||||0.037|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point~Day 8: Subjects with Titer \>=160"||||0.0370
71100175|NCT03992872|141708998|SUPERIORITY|||||||0.1806|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 8: Subjects with Titer \>=640"||||0.1806
71100176|NCT03992872|141708998|SUPERIORITY|||||||1|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 22: Subjects with Titer \>=40"||||1.0000
71100177|NCT03992872|141708998|SUPERIORITY|||||||1|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point~Day 22: Subjects with Titer \>=160"||||1.0000
71100178|NCT03992872|141708998|SUPERIORITY|||||||0.0797|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point~Day 22: Subjects with Titer \>=640"||||0.0797
71100179|NCT03992872|141708998|SUPERIORITY|||||||1|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 29: Subject with Titer \>=40"||||1.0000
71100180|NCT03992872|141708998|SUPERIORITY|||||||1|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 29: Subject with Titer \>=160"||||1.0000
71100181|NCT03992872|141708998|SUPERIORITY|||||||0.1284|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 29: Subject with Titer \>= 640"||||0.1284
70996448|NCT02528253|141501284|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.16||0.0724|TWO_SIDED|95.0|-0.6|0.03|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.60|0.0724
70996449|NCT02528253|141501284|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.19||0.4776|TWO_SIDED|95.0|-0.5|0.23|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.23|-0.50|0.4776
70996450|NCT02528253|141501284|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.19||0.1482|TWO_SIDED|95.0|-0.64|0.1|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.64|0.1482
70996451|NCT02528253|141501284|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.19||0.3249|TWO_SIDED|95.0|-0.56|0.18|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.18|-0.56|0.3249
70996452|NCT02528253|141501284|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.19||0.1997|TWO_SIDED|95.0|-0.62|0.13|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.62|0.1997
70996453|NCT02528253|141501284|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.2||0.4823|TWO_SIDED|95.0|-0.53|0.25|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.25|-0.53|0.4823
70996454|NCT02528253|141501284|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.2||0.2754|TWO_SIDED|95.0|-0.6|0.17|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.17|-0.60|0.2754
70996455|NCT02528253|141501284|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.2||0.5861|TWO_SIDED|95.0|-0.5|0.29|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.29|-0.50|0.5861
70996456|NCT02528253|141501284|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.2||0.4346|TWO_SIDED|95.0|-0.54|0.23|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.23|-0.54|0.4346
70996457|NCT02528253|141501284|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.2||0.8752|TWO_SIDED|95.0|-0.42|0.36|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.36|-0.42|0.8752
70996458|NCT02528253|141501284|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.2||0.2663|TWO_SIDED|95.0|-0.6|0.17|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.17|-0.60|0.2663
70996459|NCT02528253|141501286|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.15||0.0013|TWO_SIDED|95.0|-0.77|-0.19|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.19|-0.77|0.0013
70996460|NCT02528253|141501286|SUPERIORITY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.15||0.0001|TWO_SIDED|95.0|-0.87|-0.28|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.28|-0.87|0.0001
70996461|NCT02528253|141501286|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.2272|TWO_SIDED|95.0|-0.43|-0.1|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.10|-0.43|0.2272
70996462|NCT02528253|141501286|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.14||0.0209|TWO_SIDED|95.0|-0.58|-0.05|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.05|-0.58|0.0209
71100182|NCT03992872|141708998|SUPERIORITY|||||||1|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 57: Subject with Titer \>= 40"||||1.0000
71100183|NCT03992872|141708998|SUPERIORITY|||||||0.6411|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 57: Subject with Titer\>=160"||||0.6411
70996463|NCT02528253|141501286|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.14||0.0029|TWO_SIDED|95.0|-0.67|-0.14|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.14|-0.67|0.0029
70996464|NCT02528253|141501286|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.16||0.0002|TWO_SIDED|95.0|-0.92|-0.28|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.28|-0.92|0.0002
70996465|NCT02528253|141501286|SUPERIORITY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.1|-0.46|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.46|-1.10|<.0001
70996466|NCT02528253|141501286|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.15||0.1198|TWO_SIDED|95.0|-0.53|0.06|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.06|-0.53|0.1198
70996467|NCT02528253|141501286|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.15||0.016|TWO_SIDED|95.0|-0.66|-0.07|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.07|-0.66|0.0160
70996468|NCT02528253|141501286|SUPERIORITY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.15||0.0003|TWO_SIDED|95.0|-0.85|-0.25|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.25|-0.85|0.0003
70996469|NCT02528253|141501286|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.17||0.0091|TWO_SIDED|95.0|-0.77|-0.11|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.77|0.0091
70996470|NCT02528253|141501286|SUPERIORITY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.17||0.0007|TWO_SIDED|95.0|-0.9|-0.24|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.24|-0.90|0.0007
70996471|NCT02528253|141501286|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.15||0.2264|TWO_SIDED|95.0|-0.48|0.11|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.11|-0.48|0.2264
70996472|NCT02528253|141501286|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.15||0.0961|TWO_SIDED|95.0|-0.56|0.05|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.56|0.0961
70996473|NCT02528253|141501286|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.15||0.0121|TWO_SIDED|95.0|-0.69|-0.08|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.08|-0.69|0.0121
70996474|NCT02528253|141501286|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.18||0.027|TWO_SIDED|95.0|-0.77|-0.05|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.05|-0.77|0.0270
70996475|NCT02528253|141501286|SUPERIORITY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.18||0.0019|TWO_SIDED|95.0|-0.94|-0.21|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.21|-0.94|0.0019
70996476|NCT02528253|141501286|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.17||0.3906|TWO_SIDED|95.0|-0.48|0.19|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.48|0.3906
70996477|NCT02528253|141501286|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.17||0.1209|TWO_SIDED|95.0|-0.59|0.07|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.07|-0.59|0.1209
70996478|NCT02528253|141501286|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.17||0.0107|TWO_SIDED|95.0|-0.76|-0.1|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.10|-0.76|0.0107
70996479|NCT02528253|141501286|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.19||0.2396|TWO_SIDED|95.0|-0.61|0.15|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.15|-0.61|0.2396
70996480|NCT02528253|141501286|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.19||0.1088|TWO_SIDED|95.0|-0.69|0.07|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.07|-0.69|0.1088
70996481|NCT02528253|141501286|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.2||0.1673|TWO_SIDED|95.0|-0.65|0.11|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.11|-0.65|0.1673
70996482|NCT02528253|141501286|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.2||0.1751|TWO_SIDED|95.0|-0.66|0.12|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.12|-0.66|0.1751
70996483|NCT02528253|141501286|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3164|TWO_SIDED|95.0|-0.59|0.19|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.59|0.3164
70996484|NCT02528253|141501286|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.2||0.2253|TWO_SIDED|95.0|-0.62|0.15|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.15|-0.62|0.2253
70996485|NCT02528253|141501286|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.3408|TWO_SIDED|95.0|-0.58|0.2|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.20|-0.58|0.3408
70996486|NCT02528253|141501286|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.3391|TWO_SIDED|95.0|-0.58|0.2|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.20|-0.58|0.3391
70996487|NCT02528253|141501286|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.2||0.5818|TWO_SIDED|95.0|-0.5|0.28|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.28|-0.50|0.5818
70996488|NCT02528253|141501286|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.2||0.2562|TWO_SIDED|95.0|-0.62|0.16|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.16|-0.62|0.2562
70996489|NCT02528253|141501288|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.16||0.0137|TWO_SIDED|95.0|-0.69|-0.08|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.08|-0.69|0.0137
70996490|NCT02528253|141501288|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.16||0.0044|TWO_SIDED|95.0|-0.76|-0.14|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.14|-0.76|0.0044
70996491|NCT02528253|141501288|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.6194|TWO_SIDED|95.0|-0.35|0.21|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.21|-0.35|0.6194
70996492|NCT02528253|141501288|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.14||0.0271|TWO_SIDED|95.0|-0.59|-0.04|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-0.59|0.0271
71100184|NCT03992872|141708998|SUPERIORITY|||||||0.5382|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 57: Subject with Titer\>=640"||||0.5382
70996493|NCT02528253|141501288|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.14||0.0085|TWO_SIDED|95.0|-0.66|-0.1|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.10|-0.66|0.0085
70996494|NCT02528253|141501288|SUPERIORITY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.18||0.0027|TWO_SIDED|95.0|-0.87|-0.18|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.18|-0.87|0.0027
70996495|NCT02528253|141501288|SUPERIORITY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.13|-0.44|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.44|-1.13|<.0001
70996496|NCT02528253|141501288|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.16||0.1859|TWO_SIDED|95.0|-0.54|0.1|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.54|0.1859
70996497|NCT02528253|141501288|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.16||0.0573|TWO_SIDED|95.0|-0.63|0.01|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.01|-0.63|0.0573
70996498|NCT02528253|141501288|SUPERIORITY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.16||0.0005|TWO_SIDED|95.0|-0.88|-0.25|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.25|-0.88|0.0005
70996499|NCT02528253|141501288|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.18||0.0841|TWO_SIDED|95.0|-0.66|0.04|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-0.66|0.0841
70996500|NCT02528253|141501288|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.18||0.0074|TWO_SIDED|95.0|-0.85|-0.13|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.13|-0.85|0.0074
70996501|NCT02528253|141501288|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.16||0.316|TWO_SIDED|95.0|-0.49|0.16|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.16|-0.49|0.3160
70996502|NCT02528253|141501288|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.17||0.3763|TWO_SIDED|95.0|-0.47|0.18|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.18|-0.47|0.3763
70996503|NCT02528253|141501288|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.17||0.0505|TWO_SIDED|95.0|-0.65|0.0|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.00|-0.65|0.0505
70996504|NCT02528253|141501288|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.2||0.0118|TWO_SIDED|95.0|-0.88|-0.11|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.88|0.0118
70996505|NCT02528253|141501288|SUPERIORITY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.2||0.0012|TWO_SIDED|95.0|-1.03|-0.25|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.25|-1.03|0.0012
70996506|NCT02528253|141501288|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.18||0.2966|TWO_SIDED|95.0|-0.54|0.17|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.17|-0.54|0.2966
70996507|NCT02528253|141501288|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.0956|TWO_SIDED|95.0|-0.66|0.05|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.66|0.0956
71100185|NCT03992872|141708998|SUPERIORITY|||||||0.4915|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 182: Subject with Titer \>= 40"||||0.4915
70996508|NCT02528253|141501288|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.0117|TWO_SIDED|95.0|-0.81|-0.1|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.10|-0.81|0.0117
70996509|NCT02528253|141501288|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.2||0.3732|TWO_SIDED|95.0|-0.57|0.21|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.21|-0.57|0.3732
70996510|NCT02528253|141501288|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.2||0.1922|TWO_SIDED|95.0|-0.66|0.13|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.66|0.1922
71040881|NCT02212457|141590351|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded when, at 1 month after the second meningococcal vaccination (Visit Month 3), the lower limit of the two-sided 95% confidence interval for the between-group ratios of GMTs (ABCWY\_0\_2 versus rMenB\_0\_2) was greater than 0.5 for each of the four serogroup B test strains.|Geometric Mean Ratio|0.49|||||TWO_SIDED|95.0|0.37|0.66|||ANCOVA|||Non-inferiority response against N. meningitidis serogroup B test strain NZ98/254 of the MenABCWY vaccine to that of the Bexsero vaccine, administered according to 0, 2 month schedule.||0.66|0.37|
70996511|NCT02528253|141501288|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.21||0.2986|TWO_SIDED|95.0|-0.63|0.19|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.63|0.2986
70996512|NCT02528253|141501288|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.21||0.2584|TWO_SIDED|95.0|-0.65|0.17|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.17|-0.65|0.2584
70996513|NCT02528253|141501288|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.22||0.5195|TWO_SIDED|95.0|-0.57|0.29|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.29|-0.57|0.5195
70996514|NCT02528253|141501288|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.21||0.3752|TWO_SIDED|95.0|-0.6|0.22|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.22|-0.60|0.3752
70996515|NCT02528253|141501288|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.22||0.5157|TWO_SIDED|95.0|-0.56|0.28|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.28|-0.56|0.5157
70996516|NCT02528253|141501288|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.21||0.5065|TWO_SIDED|95.0|-0.56|0.28|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.28|-0.56|0.5065
70996517|NCT02528253|141501288|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.21||0.8373|TWO_SIDED|95.0|-0.47|0.38|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.38|-0.47|0.8373
70996518|NCT02528253|141501288|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.22||0.5146|TWO_SIDED|95.0|-0.56|0.28|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.28|-0.56|0.5146
70996519|NCT02528253|141501290|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.16||0.0059|TWO_SIDED|95.0|-0.76|-0.13|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.13|-0.76|0.0059
70996520|NCT02528253|141501290|SUPERIORITY||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.16||0.0002|TWO_SIDED|95.0|-0.93|-0.29|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.29|-0.93|0.0002
70996521|NCT02528253|141501290|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.15||0.0756|TWO_SIDED|95.0|-0.56|0.03|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.56|0.0756
70996522|NCT02528253|141501290|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.15||0.2197|TWO_SIDED|95.0|-0.47|0.11|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.11|-0.47|0.2197
70996523|NCT02528253|141501290|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.15||0.0208|TWO_SIDED|95.0|-0.63|-0.05|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.05|-0.63|0.0208
70996524|NCT02528253|141501290|SUPERIORITY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.17||0.0013|TWO_SIDED|95.0|-0.91|-0.22|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.22|-0.91|0.0013
70996525|NCT02528253|141501290|SUPERIORITY||LS Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.08|-0.39|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.39|-1.08|<.0001
70996526|NCT02528253|141501290|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.16||0.1873|TWO_SIDED|95.0|-0.53|0.1|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.53|0.1873
70996527|NCT02528253|141501290|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.16||0.0305|TWO_SIDED|95.0|-0.66|-0.03|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.03|-0.66|0.0305
70996528|NCT02528253|141501290|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.16||0.0013|TWO_SIDED|95.0|-0.84|-0.2|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.20|-0.84|0.0013
70996529|NCT02528253|141501290|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.18||0.0158|TWO_SIDED|95.0|-0.78|-0.08|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.08|-0.78|0.0158
70996530|NCT02528253|141501290|SUPERIORITY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.18||0.0015|TWO_SIDED|95.0|-0.91|-0.21|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.21|-0.91|0.0015
70996531|NCT02528253|141501290|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.16||0.4173|TWO_SIDED|95.0|-0.45|0.19|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.45|0.4173
70996532|NCT02528253|141501290|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.0659|TWO_SIDED|95.0|-0.62|0.02|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.02|-0.62|0.0659
70996533|NCT02528253|141501290|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.16||0.0078|TWO_SIDED|95.0|-0.74|-0.11|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.74|0.0078
70996534|NCT02528253|141501290|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.19||0.0737|TWO_SIDED|95.0|-0.72|0.03|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.72|0.0737
70996535|NCT02528253|141501290|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.19||0.0021|TWO_SIDED|95.0|-0.97|-0.22|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.22|-0.97|0.0021
70996536|NCT02528253|141501290|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.18||0.4535|TWO_SIDED|95.0|-0.48|0.21|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.21|-0.48|0.4535
70996537|NCT02528253|141501290|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.18||0.2271|TWO_SIDED|95.0|-0.56|0.13|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.56|0.2271
70996538|NCT02528253|141501290|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.18||0.0086|TWO_SIDED|95.0|-0.81|-0.12|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.12|-0.81|0.0086
70996539|NCT02528253|141501290|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.2||0.2243|TWO_SIDED|95.0|-0.63|0.15|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.15|-0.63|0.2243
70996540|NCT02528253|141501290|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.2||0.0331|TWO_SIDED|95.0|-0.81|-0.03|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.03|-0.81|0.0331
70996541|NCT02528253|141501290|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.2||0.1838|TWO_SIDED|95.0|-0.66|0.13|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.66|0.1838
71040882|NCT01525628|141590403|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|251.37|STANDARD_DEVIATION|31.0||1|TWO_SIDED|90.0|205.54|307.43|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 201335 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||307.43|205.54|1.0000
71040883|NCT01525628|141590403|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|131.3|STANDARD_DEVIATION|32.5||0.6514|TWO_SIDED|90.0|105.4|163.57|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 201335 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||163.57|105.40|0.6514
71040884|NCT01525628|141590404|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|381.11|STANDARD_DEVIATION|28.1||1|TWO_SIDED|90.0|317.01|458.19|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 201335 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||458.19|317.01|1.0000
71040885|NCT01525628|141590404|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|123.65|STANDARD_DEVIATION|40.0||0.4718|TWO_SIDED|90.0|94.66|161.51|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 201335 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||161.51|94.66|0.4718
71040886|NCT01525628|141590405|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|306.45|STANDARD_DEVIATION|30.7||1|TWO_SIDED|90.0|250.93|374.26|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 201335 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||374.26|250.93|1.0000
70996542|NCT02528253|141501290|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.2||0.0795|TWO_SIDED|95.0|-0.75|0.04|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-0.75|0.0795
70996543|NCT02528253|141501290|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.21||0.2847|TWO_SIDED|95.0|-0.63|0.18|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.18|-0.63|0.2847
70996544|NCT02528253|141501290|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.2||0.0745|TWO_SIDED|95.0|-0.76|0.04|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-0.76|0.0745
70996545|NCT02528253|141501290|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.311|TWO_SIDED|95.0|-0.59|0.19|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.59|0.3110
70996546|NCT02528253|141501290|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1375|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.70|0.1375
70996547|NCT02528253|141501290|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.21||0.4036|TWO_SIDED|95.0|-0.58|0.23|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.23|-0.58|0.4036
70996548|NCT02528253|141501290|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.21||0.0641|TWO_SIDED|95.0|-0.79|0.02|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.02|-0.79|0.0641
70996549|NCT02528253|141501292|SUPERIORITY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.18||0.0037|TWO_SIDED|95.0|-0.85|-0.17|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.17|-0.85|0.0037
70996550|NCT02528253|141501292|SUPERIORITY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.18||0.0013|TWO_SIDED|95.0|-0.91|-0.22|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.22|-0.91|0.0013
71040887|NCT01525628|141590405|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|129.85|STANDARD_DEVIATION|32.5||0.6185|TWO_SIDED|90.0|104.26|161.71|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 201335 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||161.71|104.26|0.6185
70996551|NCT02528253|141501292|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.16||0.1712|TWO_SIDED|95.0|-0.53|0.09|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.09|-0.53|0.1712
70996552|NCT02528253|141501292|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.16||0.0686|TWO_SIDED|95.0|-0.6|0.02|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.02|-0.60|0.0686
70996553|NCT02528253|141501292|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.16||0.0289|TWO_SIDED|95.0|-0.66|-0.04|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-0.66|0.0289
70996554|NCT02528253|141501292|SUPERIORITY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.18||0.0003|TWO_SIDED|95.0|-1.02|-0.3|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.30|-1.02|0.0003
70996555|NCT02528253|141501292|SUPERIORITY||LS Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.22|-0.49|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.49|-1.22|<.0001
70996556|NCT02528253|141501292|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.17||0.2056|TWO_SIDED|95.0|-0.55|0.12|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.12|-0.55|0.2056
70996557|NCT02528253|141501292|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.17||0.0084|TWO_SIDED|95.0|-0.78|-0.11|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.78|0.0084
70996558|NCT02528253|141501292|SUPERIORITY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.17||0.0002|TWO_SIDED|95.0|-0.98|-0.31|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.31|-0.98|0.0002
70996559|NCT02528253|141501292|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.19||0.0063|TWO_SIDED|95.0|-0.9|-0.15|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.15|-0.90|0.0063
70996560|NCT02528253|141501292|SUPERIORITY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.19||0.0002|TWO_SIDED|95.0|-1.09|-0.34|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.34|-1.09|0.0002
70996561|NCT02528253|141501292|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.18||0.1155|TWO_SIDED|95.0|-0.63|0.07|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.07|-0.63|0.1155
70996562|NCT02528253|141501292|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.18||0.1652|TWO_SIDED|95.0|-0.59|0.1|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.59|0.1652
70996563|NCT02528253|141501292|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.18||0.0129|TWO_SIDED|95.0|-0.78|-0.09|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.09|-0.78|0.0129
70996564|NCT02528253|141501292|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.21||0.0236|TWO_SIDED|95.0|-0.87|-0.06|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.06|-0.87|0.0236
70996565|NCT02528253|141501292|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.21||0.0136|TWO_SIDED|95.0|-0.93|-0.11|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.93|0.0136
70996566|NCT02528253|141501292|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.2||0.6624|TWO_SIDED|95.0|-0.47|0.3|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.30|-0.47|0.6624
70996567|NCT02528253|141501292|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.19||0.0468|TWO_SIDED|95.0|-0.75|-0.01|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.01|-0.75|0.0468
70996568|NCT02528253|141501292|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.19||0.025|TWO_SIDED|95.0|-0.81|-0.05|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.05|-0.81|0.0250
70996569|NCT02528253|141501292|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1539|TWO_SIDED|95.0|-0.72|0.11|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.11|-0.72|0.1539
70996570|NCT02528253|141501292|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0169|TWO_SIDED|95.0|-0.91|-0.09|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.09|-0.91|0.0169
71040888|NCT01525628|141590406|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|286.01|STANDARD_DEVIATION|39.4||1|TWO_SIDED|90.0|228.51|357.97|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 207127 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||357.97|228.51|1.0000
70996571|NCT02528253|141501292|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.21||0.1049|TWO_SIDED|95.0|-0.77|0.07|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.07|-0.77|0.1049
70996572|NCT02528253|141501292|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0599|TWO_SIDED|95.0|-0.82|0.02|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.02|-0.82|0.0599
70996573|NCT02528253|141501292|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.22||0.3041|TWO_SIDED|95.0|-0.65|0.2|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.20|-0.65|0.3041
70996574|NCT02528253|141501292|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0737|TWO_SIDED|95.0|-0.83|0.04|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-0.83|0.0737
70996575|NCT02528253|141501292|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.23||0.2293|TWO_SIDED|95.0|-0.71|0.17|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.17|-0.71|0.2293
70996576|NCT02528253|141501292|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.22||0.0806|TWO_SIDED|95.0|-0.82|0.05|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.82|0.0806
70996577|NCT02528253|141501292|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.22||0.368|TWO_SIDED|95.0|-0.62|0.23|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.23|-0.62|0.3680
70996578|NCT02528253|141501292|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.21||0.0893|TWO_SIDED|95.0|-0.79|0.06|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.06|-0.79|0.0893
70996579|NCT02528253|141501294|SUPERIORITY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.16||0.0007|TWO_SIDED|95.0|-0.88|-0.24|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.24|-0.88|0.0007
70996580|NCT02528253|141501294|SUPERIORITY||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.03|-0.38|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.38|-1.03|<.0001
70996581|NCT02528253|141501294|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.15||0.1291|TWO_SIDED|95.0|-0.53|0.07|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.07|-0.53|0.1291
70996582|NCT02528253|141501294|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.15||0.029|TWO_SIDED|95.0|-0.63|-0.03|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.03|-0.63|0.0290
70996583|NCT02528253|141501294|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.15||0.0015|TWO_SIDED|95.0|-0.77|-0.18|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.18|-0.77|0.0015
70996584|NCT02528253|141501294|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.18||0.0041|TWO_SIDED|95.0|-0.87|-0.17|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.17|-0.87|0.0041
70996585|NCT02528253|141501294|SUPERIORITY||LS Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.25|-0.54|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.54|-1.25|<.0001
70996586|NCT02528253|141501294|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.17||0.1799|TWO_SIDED|95.0|-0.55|0.1|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.55|0.1799
70996587|NCT02528253|141501294|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.0696|TWO_SIDED|95.0|-0.62|0.02|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.02|-0.62|0.0696
70996588|NCT02528253|141501294|SUPERIORITY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-0.99|-0.35|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.35|-0.99|<.0001
70996589|NCT02528253|141501294|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.18||0.0387|TWO_SIDED|95.0|-0.74|-0.02|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.74|0.0387
70996590|NCT02528253|141501294|SUPERIORITY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.18||0.0005|TWO_SIDED|95.0|-1.0|-0.28|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.28|-1.00|0.0005
70996591|NCT02528253|141501294|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.17||0.2768|TWO_SIDED|95.0|-0.51|0.15|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.15|-0.51|0.2768
70996592|NCT02528253|141501294|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.2408|TWO_SIDED|95.0|-0.53|0.13|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.53|0.2408
70996593|NCT02528253|141501294|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.17||0.0064|TWO_SIDED|95.0|-0.78|-0.13|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.13|-0.78|0.0064
70996594|NCT02528253|141501294|SUPERIORITY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.2||0.0115|TWO_SIDED|95.0|-0.9|-0.11|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.90|0.0115
70996595|NCT02528253|141501294|SUPERIORITY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.2||0.0006|TWO_SIDED|95.0|-1.08|-0.29|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.29|-1.08|0.0006
70996596|NCT02528253|141501294|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.18||0.2028|TWO_SIDED|95.0|-0.59|0.13|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.59|0.2028
71100186|NCT03992872|141708998|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 182: Subject with Titer \>= 160"||||>0.9999
71100187|NCT03992872|141708998|SUPERIORITY|||||||0.552|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 182: Subject with Titer \>= 640"||||0.5520
71100188|NCT03992872|141708999|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|1.51||||0.0277|TWO_SIDED|95.0|1.05|2.19||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 1: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||2.19|1.05|0.0277
70996597|NCT02528253|141501294|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.18||0.1351|TWO_SIDED|95.0|-0.64|0.09|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.09|-0.64|0.1351
70996598|NCT02528253|141501294|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.18||0.0133|TWO_SIDED|95.0|-0.82|-0.09|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.09|-0.82|0.0133
70996599|NCT02528253|141501294|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.2||0.2157|TWO_SIDED|95.0|-0.65|0.15|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.15|-0.65|0.2157
70996600|NCT02528253|141501294|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.2||0.0781|TWO_SIDED|95.0|-0.76|0.04|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-0.76|0.0781
70996601|NCT02528253|141501294|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.3527|TWO_SIDED|95.0|-0.62|0.22|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.22|-0.62|0.3527
70996602|NCT02528253|141501294|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.22||0.2994|TWO_SIDED|95.0|-0.65|0.2|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.20|-0.65|0.2994
70996603|NCT02528253|141501294|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.22||0.3326|TWO_SIDED|95.0|-0.63|0.21|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.21|-0.63|0.3326
70996604|NCT02528253|141501294|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.21||0.2822|TWO_SIDED|95.0|-0.65|0.19|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.65|0.2822
70996605|NCT02528253|141501294|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.22||0.4932|TWO_SIDED|95.0|-0.57|0.28|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.28|-0.57|0.4932
70996606|NCT02528253|141501294|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.22||0.4571|TWO_SIDED|95.0|-0.58|0.26|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.26|-0.58|0.4571
70996607|NCT02528253|141501294|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.22||0.5586|TWO_SIDED|95.0|-0.56|0.3|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.30|-0.56|0.5586
70996608|NCT02528253|141501294|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.22||0.2664|TWO_SIDED|95.0|-0.67|0.19|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.67|0.2664
70996609|NCT02528253|141501296|SUPERIORITY||Odds Ratio (OR)|2.14||||0.001|TWO_SIDED|95.0|1.36|3.36|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||3.36|1.36|0.0010
70996610|NCT02528253|141501296|SUPERIORITY||Odds Ratio (OR)|2.68|||<|0.0001|TWO_SIDED|95.0|1.73|4.16|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||4.16|1.73|<.0001
70996611|NCT02528253|141501296|SUPERIORITY||Odds Ratio (OR)|1.62||||0.03|TWO_SIDED|95.0|1.05|2.51|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||2.51|1.05|0.0300
70996612|NCT02528253|141501296|SUPERIORITY||Odds Ratio (OR)|2.03|||<|0.0001|TWO_SIDED|95.0|1.44|2.86|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||2.86|1.44|<.0001
71040889|NCT01525628|141590406|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|150.45|STANDARD_DEVIATION|55.1||0.821|TWO_SIDED|90.0|106.81|211.91|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 207127 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||211.91|106.81|0.8210
71040890|NCT01525628|141590407|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|349.9|STANDARD_DEVIATION|46.4||1|TWO_SIDED|90.0|269.12|454.93|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 207127 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||454.93|269.12|1.0000
71040891|NCT01525628|141590407|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|176.56|STANDARD_DEVIATION|50.1||0.9533|TWO_SIDED|90.0|125.95|247.5|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 207127 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||247.50|125.95|0.9533
71040892|NCT01525628|141590408|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|322.68|STANDARD_DEVIATION|40.4||1|TWO_SIDED|90.0|256.24|406.34|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 207127 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||406.34|256.24|1.0000
71040893|NCT01525628|141590408|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|145.93|STANDARD_DEVIATION|66.2||0.7461|TWO_SIDED|90.0|97.83|217.69|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 207127 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||217.69|97.83|0.7461
71040894|NCT01525628|141590409|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|355.04|STANDARD_DEVIATION|29.9||1|TWO_SIDED|90.0|298.13|422.83|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 208833 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||422.83|298.13|1.0000
70996613|NCT02528253|141501296|SUPERIORITY||Odds Ratio (OR)|2.37|||<|0.0001|TWO_SIDED|95.0|1.69|3.32|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||3.32|1.69|<.0001
70996614|NCT02528253|141501296|SUPERIORITY||Odds Ratio (OR)|1.44||||0.029|TWO_SIDED|95.0|1.04|1.99|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.99|1.04|0.0290
70996615|NCT02528253|141501296|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0003|TWO_SIDED|95.0|1.31|2.47|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||2.47|1.31|0.0003
70996616|NCT02528253|141501296|SUPERIORITY||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.62|3.03|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||3.03|1.62|<.0001
70996617|NCT02528253|141501296|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0033|TWO_SIDED|95.0|1.16|2.1|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||2.10|1.16|0.0033
70996618|NCT02528253|141501296|SUPERIORITY||Odds Ratio (OR)|1.41||||0.0179|TWO_SIDED|95.0|1.06|1.88|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.88|1.06|0.0179
70996619|NCT02528253|141501296|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0021|TWO_SIDED|95.0|1.18|2.08|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||2.08|1.18|0.0021
70996620|NCT02528253|141501296|SUPERIORITY||Odds Ratio (OR)|1.06||||0.6629|TWO_SIDED|95.0|0.81|1.38|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.38|0.81|0.6629
70996621|NCT02528253|141501296|SUPERIORITY||Odds Ratio (OR)|1.35||||0.0251|TWO_SIDED|95.0|1.04|1.75|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.75|1.04|0.0251
70996622|NCT02528253|141501296|SUPERIORITY||Odds Ratio (OR)|1.22||||0.1278|TWO_SIDED|95.0|0.94|1.59|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.59|0.94|0.1278
71100189|NCT03992872|141708999|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|1.83||||0.0088|TWO_SIDED|95.0|1.17|2.86||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 22: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||2.86|1.17|0.0088
71100190|NCT03992872|141708999|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|1.68||||0.0475|TWO_SIDED|95.0|1.01|2.82||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 29: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||2.82|1.01|0.0475
70996623|NCT02528253|141501296|SUPERIORITY||Odds Ratio (OR)|1.27||||0.0749|TWO_SIDED|95.0|0.98|1.65|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.65|0.98|0.0749
70996624|NCT02528253|141501296|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0633|TWO_SIDED|95.0|0.99|1.66|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.66|0.99|0.0633
70996625|NCT02528253|141501296|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0626|TWO_SIDED|95.0|0.99|1.67|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.67|0.99|0.0626
70996626|NCT02528253|141501296|SUPERIORITY||Odds Ratio (OR)|1.16||||0.2727|TWO_SIDED|95.0|0.89|1.51|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.51|0.89|0.2727
70996627|NCT02528253|141501296|SUPERIORITY||Odds Ratio (OR)|1.2||||0.1749|TWO_SIDED|95.0|0.92|1.57|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.57|0.92|0.1749
70996628|NCT02528253|141501296|SUPERIORITY||Odds Ratio (OR)|1.09||||0.5239|TWO_SIDED|95.0|0.84|1.42|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.42|0.84|0.5239
70996629|NCT02528253|141501296|SUPERIORITY||Odds Ratio (OR)|1.14||||0.3336|TWO_SIDED|95.0|0.87|1.49|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.49|0.87|0.3336
70996630|NCT02528253|141501296|SUPERIORITY||Odds Ratio (OR)|1.18||||0.2163|TWO_SIDED|95.0|0.91|1.54|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.54|0.91|0.2163
70996631|NCT02528253|141501297|SUPERIORITY||Odds Ratio (OR)|1.28||||0.326|TWO_SIDED|95.0|0.78|2.08|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.08|0.78|0.3260
70996632|NCT02528253|141501297|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0445|TWO_SIDED|95.0|1.01|2.56|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.56|1.01|0.0445
70996633|NCT02528253|141501297|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9263|TWO_SIDED|95.0|0.65|1.61|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.61|0.65|0.9263
70996634|NCT02528253|141501297|SUPERIORITY||Odds Ratio (OR)|1.25||||0.3194|TWO_SIDED|95.0|0.81|1.94|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.94|0.81|0.3194
70996635|NCT02528253|141501297|SUPERIORITY||Odds Ratio (OR)|1.58||||0.0308|TWO_SIDED|95.0|1.04|2.38|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.38|1.04|0.0308
70996636|NCT02528253|141501297|SUPERIORITY||Odds Ratio (OR)|1.79||||0.0048|TWO_SIDED|95.0|1.2|2.69|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.69|1.20|0.0048
71100191|NCT03992872|141709000|SUPERIORITY|||||||1|||||||Fisher Exact|"Day 22.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||1.00
71100192|NCT03992872|141709000|SUPERIORITY|||||||1|||||||Fisher Exact|"Day 29.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||1.00
70996637|NCT02528253|141501297|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0114|TWO_SIDED|95.0|1.12|2.51|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.51|1.12|0.0114
70996638|NCT02528253|141501297|SUPERIORITY||Odds Ratio (OR)|1.06||||0.7857|TWO_SIDED|95.0|0.71|1.56|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.56|0.71|0.7857
70996639|NCT02528253|141501297|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0041|TWO_SIDED|95.0|1.18|2.44|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.44|1.18|0.0041
70996640|NCT02528253|141501297|SUPERIORITY||Odds Ratio (OR)|1.59||||0.0109|TWO_SIDED|95.0|1.11|2.28|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.28|1.11|0.0109
70996641|NCT02528253|141501297|SUPERIORITY||Odds Ratio (OR)|1.53||||0.0363|TWO_SIDED|95.0|1.03|2.27|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.27|1.03|0.0363
70996642|NCT02528253|141501297|SUPERIORITY||Odds Ratio (OR)|1.76||||0.004|TWO_SIDED|95.0|1.2|2.59|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.59|1.20|0.0040
70996643|NCT02528253|141501297|SUPERIORITY||Odds Ratio (OR)|1.27||||0.1992|TWO_SIDED|95.0|0.88|1.84|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.84|0.88|0.1992
70996644|NCT02528253|141501297|SUPERIORITY||Odds Ratio (OR)|1.2||||0.3084|TWO_SIDED|95.0|0.85|1.7|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.70|0.85|0.3084
70996645|NCT02528253|141501297|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0586|TWO_SIDED|95.0|0.99|1.94|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.94|0.99|0.0586
70996646|NCT02528253|141501297|SUPERIORITY||Odds Ratio (OR)|1.39||||0.063|TWO_SIDED|95.0|0.98|1.97|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.97|0.98|0.0630
70996647|NCT02528253|141501297|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0347|TWO_SIDED|95.0|1.03|2.04|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.04|1.03|0.0347
70996648|NCT02528253|141501297|SUPERIORITY||Odds Ratio (OR)|0.96||||0.79|TWO_SIDED|95.0|0.69|1.33|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.33|0.69|0.7900
70996649|NCT02528253|141501297|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0207|TWO_SIDED|95.0|1.06|2.0|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.00|1.06|0.0207
70996650|NCT02528253|141501297|SUPERIORITY||Odds Ratio (OR)|1.51||||0.0093|TWO_SIDED|95.0|1.11|2.07|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.07|1.11|0.0093
70996651|NCT02528253|141501297|SUPERIORITY||Odds Ratio (OR)|1.39||||0.04|TWO_SIDED|95.0|1.02|1.91|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.91|1.02|0.0400
71040895|NCT01525628|141590409|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|120.67|STANDARD_DEVIATION|58.3||0.4337|TWO_SIDED|90.0|83.68|174.01|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 208833 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||174.01|83.68|0.4337
70996652|NCT02528253|141501297|SUPERIORITY||Odds Ratio (OR)|1.21||||0.2478|TWO_SIDED|95.0|0.88|1.65|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.65|0.88|0.2478
71040896|NCT01525628|141590410|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|397.73|STANDARD_DEVIATION|31.6||1|TWO_SIDED|90.0|330.79|478.22|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 208833 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||478.22|330.79|1.0000
70996653|NCT02528253|141501297|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0304|TWO_SIDED|95.0|1.03|1.96|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.96|1.03|0.0304
70996654|NCT02528253|141501297|SUPERIORITY||Odds Ratio (OR)|1.12||||0.4763|TWO_SIDED|95.0|0.81|1.56|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.56|0.81|0.4763
70996655|NCT02528253|141501297|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0178|TWO_SIDED|95.0|1.07|2.01|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.01|1.07|0.0178
70996656|NCT02528253|141501297|SUPERIORITY||Odds Ratio (OR)|1.11||||0.5223|TWO_SIDED|95.0|0.8|1.53|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.53|0.80|0.5223
70996657|NCT02528253|141501297|SUPERIORITY||Odds Ratio (OR)|1.25||||0.1708|TWO_SIDED|95.0|0.91|1.72|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.72|0.91|0.1708
70996658|NCT02528253|141501297|SUPERIORITY||Odds Ratio (OR)|1.09||||0.6022|TWO_SIDED|95.0|0.79|1.5|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.50|0.79|0.6022
70996659|NCT02528253|141501297|SUPERIORITY||Odds Ratio (OR)|1.32||||0.0846|TWO_SIDED|95.0|0.96|1.81|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.81|0.96|0.0846
70996660|NCT02528253|141501297|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9626|TWO_SIDED|95.0|0.73|1.39|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.39|0.73|0.9626
70996661|NCT02528253|141501301|SUPERIORITY||LS Mean Difference|0.74|STANDARD_ERROR_OF_MEAN|1.64||0.6508|TWO_SIDED|95.0|-2.49|3.98|||ANCOVA|||Change at Week 16: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.98|-2.49|0.6508
70996662|NCT02528253|141501301|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|1.66||0.9629|TWO_SIDED|95.0|-3.33|3.18|||ANCOVA|||Change at Week 16: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.18|-3.33|0.9629
70996663|NCT02528253|141501301|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.57||0.7007|TWO_SIDED|95.0|-2.48|3.69|||ANCOVA|||Change at Week 16: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.69|-2.48|0.7007
70996664|NCT02528253|141501301|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|1.58||0.8902|TWO_SIDED|95.0|-3.32|2.88|||ANCOVA|||Change at Week 16: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.88|-3.32|0.8902
70996665|NCT02528253|141501301|SUPERIORITY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|1.53||0.5698|TWO_SIDED|95.0|-3.89|2.15|||ANCOVA|||Change at Week 56: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.15|-3.89|0.5698
70996666|NCT02528253|141501301|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.53||0.8464|TWO_SIDED|95.0|-3.32|2.72|||ANCOVA|||Change at Week 56: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.72|-3.32|0.8464
71040897|NCT01525628|141590410|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|142.27|STANDARD_DEVIATION|53.1||0.7346|TWO_SIDED|90.0|99.49|203.44|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 208833 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||203.44|99.49|0.7346
71040898|NCT01525628|141590411|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|403.86|STANDARD_DEVIATION|33.6||1|TWO_SIDED|90.0|332.19|490.99|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 208833 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||490.99|332.19|1.0000
71040899|NCT01525628|141590411|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|116.96|STANDARD_DEVIATION|73.1||0.3968|TWO_SIDED|90.0|75.38|181.47|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 208833 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||181.47|75.38|0.3968
71040900|NCT01525628|141590412|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|408.66|STANDARD_DEVIATION|45.9||1|TWO_SIDED|90.0|315.15|529.9|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||529.90|315.15|1.0000
70996667|NCT02528253|141501301|SUPERIORITY||LS Mean Difference|-4.03|STANDARD_ERROR_OF_MEAN|2.39||0.0919|TWO_SIDED|95.0|-8.72|0.66|||ANCOVA|||Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||0.66|-8.72|0.0919
71100193|NCT03992872|141709001|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|45.17|||||TWO_SIDED|||||"P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.~P-value = NE~NE = Not estimable due to lack of response."|||"Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.~95% CI \[NE,NE\]~NE = Not estimable due to lack of response."|Day 1: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||||
71100194|NCT03992872|141709001|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|47.34|||||TWO_SIDED|||||"P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.~P-value = NE NE = Not estimable due to lack of response."|||"Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.~95% CI \[NE,NE\] NE = Not estimable due to lack of response."|Day 22: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||||
70996668|NCT02528253|141501301|SUPERIORITY||LS Mean Difference|-4.76|STANDARD_ERROR_OF_MEAN|2.4||0.0477|TWO_SIDED|95.0|-9.47|-0.05|||ANCOVA|||Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-9.47|0.0477
70996669|NCT02528253|141501301|SUPERIORITY||LS Mean Difference|-1.65|STANDARD_ERROR_OF_MEAN|2.3||0.4735|TWO_SIDED|95.0|-6.17|2.87|||ANCOVA|||Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.87|-6.17|0.4735
70996670|NCT02528253|141501301|SUPERIORITY||LS Mean Difference|-2.38|STANDARD_ERROR_OF_MEAN|2.26||0.2935|TWO_SIDED|95.0|-6.82|2.06|||ANCOVA|||Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.06|-6.82|0.2935
70996671|NCT02528253|141501301|SUPERIORITY||LS Mean Difference|-3.11|STANDARD_ERROR_OF_MEAN|2.27||0.1714|TWO_SIDED|95.0|-7.56|1.35|||ANCOVA|||Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.35|-7.56|0.1714
71040901|NCT01525628|141590412|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|301.19|STANDARD_DEVIATION|62.1||0.9993|TWO_SIDED|90.0|204.61|443.35|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||443.35|204.61|0.9993
71040902|NCT01525628|141590413|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|450.51|STANDARD_DEVIATION|48.0||1|TWO_SIDED|90.0|343.67|590.57|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||590.57|343.67|1.0000
70996672|NCT02528253|141501301|SUPERIORITY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|2.75||0.7521|TWO_SIDED|95.0|-6.3|4.56|||ANCOVA|||Change at Week 56: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||4.56|-6.30|0.7521
70996673|NCT02528253|141501301|SUPERIORITY||LS Mean Difference|-2.81|STANDARD_ERROR_OF_MEAN|2.75||0.3078|TWO_SIDED|95.0|-8.24|2.61|||ANCOVA|||Change at Week 56: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.61|-8.24|0.3078
70996674|NCT02528253|141501301|SUPERIORITY||LS Mean Difference|-3.95|STANDARD_ERROR_OF_MEAN|2.46||0.109|TWO_SIDED|95.0|-8.78|0.88|||ANCOVA|||Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||0.88|-8.78|0.1090
70996675|NCT02528253|141501301|SUPERIORITY||LS Mean Difference|-5.41|STANDARD_ERROR_OF_MEAN|2.47||0.0289|TWO_SIDED|95.0|-10.27|-0.56|||ANCOVA|||Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||-0.56|-10.27|0.0289
70996676|NCT02528253|141501301|SUPERIORITY||LS Mean Difference|-1.75|STANDARD_ERROR_OF_MEAN|2.37||0.4613|TWO_SIDED|95.0|-6.41|2.91|||ANCOVA|||Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.91|-6.41|0.4613
70996677|NCT02528253|141501301|SUPERIORITY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|2.33||0.346|TWO_SIDED|95.0|-6.78|2.38|||ANCOVA|||Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.38|-6.78|0.3460
70996678|NCT02528253|141501301|SUPERIORITY||LS Mean Difference|-3.66|STANDARD_ERROR_OF_MEAN|2.34||0.1179|TWO_SIDED|95.0|-8.26|0.93|||ANCOVA|||Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||0.93|-8.26|0.1179
70996679|NCT02528253|141501301|SUPERIORITY||LS Mean Difference|-1.93|STANDARD_ERROR_OF_MEAN|2.97||0.5151|TWO_SIDED|95.0|-7.78|3.92|||ANCOVA|||Change at Week 56: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.92|-7.78|0.5151
70996680|NCT02528253|141501301|SUPERIORITY||LS Mean Difference|-3.38|STANDARD_ERROR_OF_MEAN|2.96||0.255|TWO_SIDED|95.0|-9.22|2.46|||ANCOVA|||Change at Week 56: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.46|-9.22|0.2550
70996681|NCT02528253|141501301|SUPERIORITY||LS Mean Difference|-4.18|STANDARD_ERROR_OF_MEAN|1.73||0.0157|TWO_SIDED|95.0|-7.57|-0.79|||ANCOVA|||Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||-0.79|-7.57|0.0157
70996682|NCT02528253|141501301|SUPERIORITY||LS Mean Difference|-4.18|STANDARD_ERROR_OF_MEAN|1.73||0.0159|TWO_SIDED|95.0|-7.57|-0.78|||ANCOVA|||Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||-0.78|-7.57|0.0159
70996683|NCT02528253|141501301|SUPERIORITY||LS Mean Difference|-2.75|STANDARD_ERROR_OF_MEAN|1.62||0.0896|TWO_SIDED|95.0|-5.94|0.43|||ANCOVA|||Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||0.43|-5.94|0.0896
70996684|NCT02528253|141501301|SUPERIORITY||LS Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|1.6||0.3749|TWO_SIDED|95.0|-4.57|1.72|||ANCOVA|||Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.72|-4.57|0.3749
71040903|NCT01525628|141590413|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|341.96|STANDARD_DEVIATION|61.1||0.9996|TWO_SIDED|90.0|229.22|510.13|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||510.13|229.22|0.9996
70996685|NCT02528253|141501301|SUPERIORITY||LS Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|1.59||0.3733|TWO_SIDED|95.0|-4.55|1.71|||ANCOVA|||Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.71|-4.55|0.3733
70996686|NCT02528253|141501301|SUPERIORITY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|2.17||0.8056|TWO_SIDED|95.0|-4.8|3.73|||ANCOVA|||Change at Week 56: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.73|-4.80|0.8056
70996687|NCT02528253|141501301|SUPERIORITY||LS Mean Difference|-1.16|STANDARD_ERROR_OF_MEAN|2.08||0.5764|TWO_SIDED|95.0|-5.25|2.93|||ANCOVA|||Change at Week 56: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.93|-5.25|0.5764
70996688|NCT02528253|141501302|SUPERIORITY||Odds Ratio (OR)|0.93||||0.7366|TWO_SIDED|95.0|0.62|1.41|||Regression, Logistic|||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.41|0.62|0.7366
70996689|NCT02528253|141501302|SUPERIORITY||Odds Ratio (OR)|1.06||||0.771|TWO_SIDED|95.0|0.71|1.58|||Regression, Logistic|||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.58|0.71|0.7710
70996690|NCT02528253|141501303|SUPERIORITY|||||||0.4724|||||||Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.4724
70996691|NCT02528253|141501303|SUPERIORITY|||||||0.7142|||||||Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.7142
70996692|NCT02528253|141501304|SUPERIORITY||Odds Ratio (OR)|1.12||||0.396|TWO_SIDED|95.0|0.87|1.44|||Regression, Logistic|||Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.44|0.87|0.3960
70996693|NCT02528253|141501304|SUPERIORITY||Odds Ratio (OR)|0.93||||0.5932|TWO_SIDED|95.0|0.73|1.2|||Regression, Logistic|||Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.20|0.73|0.5932
70996694|NCT02528253|141501304|SUPERIORITY||Odds Ratio (OR)|1.13||||0.3326|TWO_SIDED|95.0|0.88|1.46|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.46|0.88|0.3326
70996695|NCT02528253|141501304|SUPERIORITY||Odds Ratio (OR)|0.84||||0.1765|TWO_SIDED|95.0|0.65|1.08|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.08|0.65|0.1765
70996696|NCT02528253|141501304|SUPERIORITY||Odds Ratio (OR)|1.08||||0.5619|TWO_SIDED|95.0|0.84|1.39|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.39|0.84|0.5619
70996697|NCT02528253|141501304|SUPERIORITY||Odds Ratio (OR)|0.89||||0.3909|TWO_SIDED|95.0|0.69|1.16|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.16|0.69|0.3909
70996698|NCT02528253|141501304|SUPERIORITY||Odds Ratio (OR)|1.04||||0.7562|TWO_SIDED|95.0|0.8|1.35|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.35|0.80|0.7562
71040904|NCT01525628|141590414|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|466.92|STANDARD_DEVIATION|47.6||1|TWO_SIDED|90.0|357.02|610.66|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||610.66|357.02|1.0000
71040905|NCT01525628|141590414|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|298.57|STANDARD_DEVIATION|79.2||0.9972|TWO_SIDED|90.0|187.22|476.15|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||476.15|187.22|0.9972
71040906|NCT01525628|141590415|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|528.95|STANDARD_DEVIATION|42.0||1|TWO_SIDED|90.0|415.88|672.75|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168-ag at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||672.75|415.88|1.0000
71040907|NCT01525628|141590415|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|384.0|STANDARD_DEVIATION|69.2||0.9998|TWO_SIDED|90.0|251.56|586.16|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168-ag at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||586.16|251.56|0.9998
71040908|NCT01525628|141590416|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|569.81|STANDARD_DEVIATION|42.2||1|TWO_SIDED|90.0|447.49|725.57|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168-ag at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||725.57|447.49|1.0000
71040909|NCT01525628|141590416|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|441.89|STANDARD_DEVIATION|66.9||0.9999|TWO_SIDED|90.0|286.81|680.82|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168-ag at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||680.82|286.81|0.9999
71040910|NCT01525628|141590417|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|606.29|STANDARD_DEVIATION|44.2||1|TWO_SIDED|90.0|471.42|779.74|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168-ag at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||779.74|471.42|1.0000
70996699|NCT02528253|141501304|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9476|TWO_SIDED|95.0|0.78|1.31|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.31|0.78|0.9476
70996700|NCT02528253|141501304|SUPERIORITY||Odds Ratio (OR)|1.04||||0.7746|TWO_SIDED|95.0|0.79|1.36|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.36|0.79|0.7746
70996701|NCT02528253|141501304|SUPERIORITY||Odds Ratio (OR)|0.94||||0.6377|TWO_SIDED|95.0|0.71|1.23|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.23|0.71|0.6377
70996702|NCT02528253|141501304|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8532|TWO_SIDED|95.0|0.79|1.33|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.33|0.79|0.8532
70996703|NCT02528253|141501304|SUPERIORITY||Odds Ratio (OR)|1.08||||0.5644|TWO_SIDED|95.0|0.83|1.4|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.40|0.83|0.5644
70996704|NCT02528253|141501304|SUPERIORITY||Odds Ratio (OR)|1.04||||0.769|TWO_SIDED|0.769|0.8|1.35|||Regression, Logistic|||Week 32: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.35|0.80|0.7690
70996705|NCT02528253|141501304|SUPERIORITY||Odds Ratio (OR)|1.11||||0.4321|TWO_SIDED|95.0|0.85|1.44|||Regression, Logistic|||Week 32: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.44|0.85|0.4321
70996706|NCT02528253|141501304|SUPERIORITY||Odds Ratio (OR)|1.04||||0.7714|TWO_SIDED|95.0|0.8|1.35|||Regression, Logistic|||Week 40: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.35|0.80|0.7714
70996707|NCT02528253|141501304|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8389|TWO_SIDED|95.0|0.79|1.34|||Regression, Logistic|||Week 40: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.34|0.79|0.8389
70996708|NCT02528253|141501304|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9383|TWO_SIDED|95.0|0.76|1.29|||Regression, Logistic|||Week 48: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.29|0.76|0.9383
70996709|NCT02528253|141501304|SUPERIORITY||Odds Ratio (OR)|1.02||||0.88|TWO_SIDED|95.0|0.78|1.33|||Regression, Logistic|||Week 48: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.33|0.78|0.8800
70996710|NCT02528253|141501304|SUPERIORITY||Odds Ratio (OR)|0.97||||0.7946|TWO_SIDED|95.0|0.74|1.26|||Regression, Logistic|||Week 56: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.26|0.74|0.7946
70996711|NCT02528253|141501304|SUPERIORITY||Odds Ratio (OR)|0.96||||0.7803|TWO_SIDED|95.0|0.74|1.25|||Regression, Logistic|||Week 56: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.25|0.74|0.7803
70996712|NCT02528253|141501306|SUPERIORITY||LS Mean Ratio|1.16|STANDARD_ERROR_OF_MEAN|0.11||0.1272|TWO_SIDED|95.0|0.96|1.41|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.41|0.96|0.1272
70996713|NCT02528253|141501306|SUPERIORITY||LS Mean Ratio|1.05|STANDARD_ERROR_OF_MEAN|0.1||0.6322|TWO_SIDED|95.0|0.86|1.27|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.27|0.86|0.6322
70996714|NCT02528253|141501306|SUPERIORITY||LS Mean Ratio|1.1|STANDARD_ERROR_OF_MEAN|0.12||0.3559|TWO_SIDED|95.0|0.89|1.36|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.36|0.89|0.3559
70996715|NCT02528253|141501306|SUPERIORITY||LS Mean Ratio|0.96||||0.6798|TWO_SIDED|95.0|0.77|1.18|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.18|0.77|0.6798
70996716|NCT02528253|141501306|SUPERIORITY||LS Mean Ratio|1.14||||0.267|TWO_SIDED|95.0|0.9|1.44|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.44|0.90|0.2670
70996717|NCT02528253|141501306|SUPERIORITY||LS Mean Ratio|0.94||||0.5865|TWO_SIDED|95.0|0.74|1.19|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.19|0.74|0.5865
70996718|NCT02528253|141501306|SUPERIORITY||LS Mean Ratio|1.13||||0.3378|TWO_SIDED|95.0|0.88|1.47|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.47|0.88|0.3378
70996719|NCT02528253|141501306|SUPERIORITY||LS Mean Ratio|0.92||||0.551|TWO_SIDED|95.0|0.71|1.2|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.20|0.71|0.5510
70996720|NCT02528253|141501306|SUPERIORITY||LS Mean Ratio|1.2|STANDARD_ERROR_OF_MEAN|0.18||0.2088|TWO_SIDED|95.0|0.9|1.6|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.60|0.90|0.2088
70996721|NCT02528253|141501306|SUPERIORITY||LS Mean Ratio|0.98|STANDARD_ERROR_OF_MEAN|0.14||0.8692|TWO_SIDED|95.0|0.73|1.3|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.30|0.73|0.8692
70996722|NCT02528253|141501306|SUPERIORITY||LS Mean Ratio|1.03|STANDARD_ERROR_OF_MEAN|0.14||0.8444|TWO_SIDED|95.0|0.78|1.35|||Negative binomial model|||Week 24: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.35|0.78|0.8444
70996723|NCT02528253|141501306|SUPERIORITY||LS Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.14||0.8936|TWO_SIDED|95.0|0.78|1.34|||Negative binomial model|||Week 24: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.34|0.78|0.8936
70996724|NCT02528253|141501306|SUPERIORITY||LS Mean Ratio|0.98|STANDARD_ERROR_OF_MEAN|0.14||0.8716|TWO_SIDED|95.0|0.75|1.28|||Negative binomial model|||Week 32: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.28|0.75|0.8716
70996725|NCT02528253|141501306|SUPERIORITY||LS Mean Ratio|0.98|STANDARD_ERROR_OF_MEAN|0.14||0.8827|TWO_SIDED|95.0|0.75|1.29|||Negative binomial model|||Week 32: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.29|0.75|0.8827
70996726|NCT02528253|141501306|SUPERIORITY||LS Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.14||0.8996|TWO_SIDED|95.0|0.77|1.34|||Negative binomial model|||Week 40: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.34|0.77|0.8996
70996727|NCT02528253|141501306|SUPERIORITY||LS Mean Ratio|0.91|STANDARD_ERROR_OF_MEAN|0.13||0.488|TWO_SIDED|95.0|0.69|1.2|||Negative binomial model|||Week 40: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.20|0.69|0.4880
70996728|NCT02528253|141501306|SUPERIORITY||LS Mean Ratio|0.96|STANDARD_ERROR_OF_MEAN|0.14||0.7938|TWO_SIDED|95.0|0.73|1.27|||Negative binomial model|||Week 48: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.27|0.73|0.7938
70996729|NCT02528253|141501306|SUPERIORITY||LS Mean Ratio|0.91|STANDARD_ERROR_OF_MEAN|0.13||0.5092|TWO_SIDED|95.0|0.69|1.2|||Negative binomial model|||Week 48: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.20|0.69|0.5092
70996730|NCT02528253|141501306|SUPERIORITY||LS Mean Ratio|0.93|STANDARD_ERROR_OF_MEAN|0.13||0.6148|TWO_SIDED|95.0|0.71|1.22|||Negative binomial model|||Week 56: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.22|0.71|0.6148
70996731|NCT02528253|141501306|SUPERIORITY||LS Mean Ratio|0.86|STANDARD_ERROR_OF_MEAN|0.12||0.2844|TWO_SIDED|95.0|0.66|1.13|||Negative binomial model|||Week 56: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.13|0.66|0.2844
70996732|NCT02528253|141501308|SUPERIORITY||LS Mean Ratio|1.1|STANDARD_ERROR_OF_MEAN|0.25||0.6764|TWO_SIDED|95.0|0.7|1.73|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.73|0.70|0.6764
70996733|NCT02528253|141501308|SUPERIORITY||LS Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.23||0.9351|TWO_SIDED|95.0|0.65|1.6|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.60|0.65|0.9351
70996734|NCT02528253|141501308|SUPERIORITY||LS Mean Ratio|0.97|STANDARD_ERROR_OF_MEAN|0.2||0.8731|TWO_SIDED|95.0|0.64|1.46|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.46|0.64|0.8731
70996735|NCT02528253|141501308|SUPERIORITY||LS Mean Ratio|1.14|STANDARD_ERROR_OF_MEAN|0.24||0.537|TWO_SIDED|95.0|0.75|1.72|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.72|0.75|0.5370
70996736|NCT02528253|141501308|SUPERIORITY||LS Mean Ratio|1.05|STANDARD_ERROR_OF_MEAN|0.22||0.8031|TWO_SIDED|95.0|0.7|1.59|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.59|0.70|0.8031
70996737|NCT02528253|141501308|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.24||0.8192|TWO_SIDED|95.0|0.57|1.55|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.55|0.57|0.8192
70996738|NCT02528253|141501308|SUPERIORITY||LS Mean Ratio|0.89|STANDARD_ERROR_OF_MEAN|0.22||0.6345|TWO_SIDED|95.0|0.54|1.46|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.46|0.54|0.6345
70996739|NCT02528253|141501308|SUPERIORITY||LS Mean Ratio|0.89|STANDARD_ERROR_OF_MEAN|0.21||0.6103|TWO_SIDED|95.0|0.56|1.4|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.40|0.56|0.6103
70996740|NCT02528253|141501308|SUPERIORITY||LS Mean Ratio|1.06|STANDARD_ERROR_OF_MEAN|0.25||0.7949|TWO_SIDED|95.0|0.67|1.67|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.67|0.67|0.7949
70996741|NCT02528253|141501308|SUPERIORITY||LS Mean Ratio|1.0|STANDARD_ERROR_OF_MEAN|0.23||0.992|TWO_SIDED|95.0|0.63|1.57|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.57|0.63|0.9920
70996742|NCT02528253|141501308|SUPERIORITY||LS Mean Ratio|0.96|STANDARD_ERROR_OF_MEAN|0.27||0.8772|TWO_SIDED|95.0|0.55|1.67|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.67|0.55|0.8772
70996743|NCT02528253|141501308|SUPERIORITY||LS Mean Ratio|0.92|STANDARD_ERROR_OF_MEAN|0.26||0.7614|TWO_SIDED|95.0|0.53|1.6|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.60|0.53|0.7614
70996744|NCT02528253|141501308|SUPERIORITY||LS Mean Ratio|0.86|STANDARD_ERROR_OF_MEAN|0.22||0.5629|TWO_SIDED|95.0|0.52|1.43|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.43|0.52|0.5629
70996745|NCT02528253|141501308|SUPERIORITY||LS Mean Ratio|1.11|STANDARD_ERROR_OF_MEAN|0.29||0.6821|TWO_SIDED|95.0|0.67|1.85|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.85|0.67|0.6821
70996746|NCT02528253|141501308|SUPERIORITY||LS Mean Ratio|1.07|STANDARD_ERROR_OF_MEAN|0.28||0.8049|TWO_SIDED|95.0|0.64|1.77|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.77|0.64|0.8049
70996747|NCT02528253|141501308|SUPERIORITY||LS Mean Ratio|0.87|STANDARD_ERROR_OF_MEAN|0.27||0.6673|TWO_SIDED|95.0|0.47|1.62|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.62|0.47|0.6673
70996748|NCT02528253|141501308|SUPERIORITY||LS Mean Ratio|0.79|STANDARD_ERROR_OF_MEAN|0.25||0.4475|TWO_SIDED|95.0|0.43|1.46|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.46|0.43|0.4475
70996749|NCT02528253|141501308|SUPERIORITY||LS Mean Ratio|0.86|STANDARD_ERROR_OF_MEAN|0.25||0.5925|TWO_SIDED|95.0|0.49|1.5|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.50|0.49|0.5925
70996750|NCT02528253|141501308|SUPERIORITY||LS Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.29||0.9486|TWO_SIDED|95.0|0.58|1.79|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.79|0.58|0.9486
70996751|NCT02528253|141501308|SUPERIORITY||LS Mean Ratio|0.92|STANDARD_ERROR_OF_MEAN|0.26||0.7673|TWO_SIDED|95.0|0.52|1.61|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.61|0.52|0.7673
70996752|NCT02528253|141501308|SUPERIORITY||LS Mean Ratio|1.11|STANDARD_ERROR_OF_MEAN|0.39||0.7635|TWO_SIDED|95.0|0.56|2.2|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||2.20|0.56|0.7635
70996753|NCT02528253|141501308|SUPERIORITY||LS Mean Ratio|0.98|STANDARD_ERROR_OF_MEAN|0.34||0.9564|TWO_SIDED|95.0|0.5|1.94|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.94|0.50|0.9564
70996754|NCT02528253|141501308|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.3||0.8359|TWO_SIDED|95.0|0.5|1.75|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.75|0.50|0.8359
70996755|NCT02528253|141501308|SUPERIORITY||LS Mean Ratio|1.19|STANDARD_ERROR_OF_MEAN|0.38||0.5914|TWO_SIDED|95.0|0.64|2.21|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||2.21|0.64|0.5914
70996756|NCT02528253|141501308|SUPERIORITY||LS Mean Ratio|1.05|STANDARD_ERROR_OF_MEAN|0.33||0.8826|TWO_SIDED|95.0|0.56|1.95|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.95|0.56|0.8826
70996757|NCT02528253|141501317|SUPERIORITY||LS Mean Difference|7.02|STANDARD_ERROR_OF_MEAN|2.01||0.0005|TWO_SIDED|95.0|3.07|10.97|||ANCOVA|||TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||10.97|3.07|0.0005
70996758|NCT02528253|141501317|SUPERIORITY||LS Mean Difference|6.21|STANDARD_ERROR_OF_MEAN|2.01||0.0021|TWO_SIDED|95.0|2.26|10.15|||ANCOVA|||TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||10.15|2.26|0.0021
70996759|NCT02528253|141501317|SUPERIORITY||LS Mean Difference|4.72|STANDARD_ERROR_OF_MEAN|1.89||0.0125|TWO_SIDED|95.0|1.02|8.42|||ANCOVA|||TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||8.42|1.02|0.0125
70996760|NCT02528253|141501317|SUPERIORITY||LS Mean Difference|2.31|STANDARD_ERROR_OF_MEAN|1.87||0.2176|TWO_SIDED|95.0|-1.36|5.97|||ANCOVA|||TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||5.97|-1.36|0.2176
70996761|NCT02528253|141501317|SUPERIORITY||LS Mean Difference|1.49|STANDARD_ERROR_OF_MEAN|1.86||0.4235|TWO_SIDED|95.0|-2.16|5.14|||ANCOVA|||TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||5.14|-2.16|0.4235
70996762|NCT02528253|141501317|SUPERIORITY||LS Mean Difference|12.3|STANDARD_ERROR_OF_MEAN|4.96||0.0143|TWO_SIDED|95.0|2.5|22.11|||ANCOVA|||TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||22.11|2.50|0.0143
70996763|NCT02528253|141501317|SUPERIORITY||LS Mean Difference|12.55|STANDARD_ERROR_OF_MEAN|4.96||0.0124|TWO_SIDED|95.0|2.76|22.35|||ANCOVA|||TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||22.35|2.76|0.0124
70996764|NCT02528253|141501317|SUPERIORITY||LS Mean Difference|3.88|STANDARD_ERROR_OF_MEAN|4.29||0.3675|TWO_SIDED|95.0|-4.6|12.36|||ANCOVA|||TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||12.36|-4.60|0.3675
70996765|NCT02528253|141501317|SUPERIORITY||LS Mean Difference|8.42|STANDARD_ERROR_OF_MEAN|3.89||0.0319|TWO_SIDED|95.0|0.74|16.11|||ANCOVA|||TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||16.11|0.74|0.0319
70996766|NCT02528253|141501317|SUPERIORITY||LS Mean Difference|8.67|STANDARD_ERROR_OF_MEAN|3.9||0.0276|TWO_SIDED|95.0|0.97|16.38|||ANCOVA|||TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||16.38|0.97|0.0276
70996767|NCT02528253|141501317|SUPERIORITY||LS Mean Difference|2.57|STANDARD_ERROR_OF_MEAN|1.38||0.0627|TWO_SIDED|95.0|-0.14|5.27|||ANCOVA|||TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||5.27|-0.14|0.0627
70996768|NCT02528253|141501317|SUPERIORITY||LS Mean Difference|3.26|STANDARD_ERROR_OF_MEAN|1.38||0.0187|TWO_SIDED|95.0|0.54|5.97|||ANCOVA|||TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||5.97|0.54|0.0187
70996769|NCT02528253|141501317|SUPERIORITY||LS Mean Difference|1.52|STANDARD_ERROR_OF_MEAN|1.3||0.2419|TWO_SIDED|95.0|-1.03|4.06|||ANCOVA|||TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||4.06|-1.03|0.2419
71040911|NCT01525628|141590417|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|377.98|STANDARD_DEVIATION|82.0||0.9994|TWO_SIDED|90.0|233.48|611.91|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168-ag at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||611.91|233.48|0.9994
71040912|NCT01525628|141590418|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|97.03|STANDARD_DEVIATION|30.8||0.05|TWO_SIDED|90.0|80.0|117.69|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||117.69|80.00|0.0500
71040913|NCT01525628|141590418|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|97.1|STANDARD_DEVIATION|31.2||0.0564|TWO_SIDED|90.0|79.37|118.79|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||118.79|79.37|0.0564
71040914|NCT01525628|141590418|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|114.38|STANDARD_DEVIATION|31.9||0.2375|TWO_SIDED|90.0|92.36|141.66|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||141.66|92.36|0.2375
71040915|NCT01525628|141590418|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|139.07|STANDARD_DEVIATION|22.8||0.9082|TWO_SIDED|90.0|121.63|159.0|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||159.00|121.63|0.9082
71040916|NCT01525628|141590418|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|122.37|STANDARD_DEVIATION|29.3||0.4111|TWO_SIDED|90.0|104.11|143.84|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||143.84|104.11|0.4111
71040917|NCT01525628|141590418|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|121.43|STANDARD_DEVIATION|24.7||0.3719|TWO_SIDED|90.0|104.24|141.45|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||141.45|104.24|0.3719
71100195|NCT03992872|141709001|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|55.74|||||TWO_SIDED|||||"P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.~P-value = NE NE = Not estimable due to lack of response."|||"Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.~95% CI \[NE,NE\] NE = Not estimable due to lack of response."|Day 29: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||||
71100196|NCT03992872|141709003|SUPERIORITY|||||||1|||||||Fisher Exact|"Day 22.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||1.0000
71040918|NCT01525628|141590419|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|88.37|STANDARD_DEVIATION|20.8||0.1037|TWO_SIDED|90.0|77.39|100.89|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||100.89|77.39|0.1037
71100197|NCT03992872|141709003|SUPERIORITY|||||||1|||||||Fisher Exact|"Day 29.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||1.0000
71100198|NCT03992872|141709004|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 1: Subject with Titer \>= 40"||||<0.0001
71100199|NCT03992872|141709004|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 1: Subject with Titer \>= 160"||||<0.0001
70996770|NCT02528253|141501317|SUPERIORITY||LS Mean Difference|1.05|STANDARD_ERROR_OF_MEAN|1.28||0.4124|TWO_SIDED|95.0|-1.46|3.56|||ANCOVA|||TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||3.56|-1.46|0.4124
70996771|NCT02528253|141501317|SUPERIORITY||LS Mean Difference|1.74|STANDARD_ERROR_OF_MEAN|1.27||0.173|TWO_SIDED|95.0|-0.76|4.24|||ANCOVA|||TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||4.24|-0.76|0.1730
70996772|NCT02528253|141501317|SUPERIORITY||LS Mean Difference|5.42|STANDARD_ERROR_OF_MEAN|1.86||0.0037|TWO_SIDED|95.0|1.77|9.08|||ANCOVA|||TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||9.08|1.77|0.0037
70996773|NCT02528253|141501317|SUPERIORITY||LS Mean Difference|3.74|STANDARD_ERROR_OF_MEAN|1.86||0.0449|TWO_SIDED|95.0|0.09|7.39|||ANCOVA|||TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||7.39|0.09|0.0449
70996774|NCT02528253|141501317|SUPERIORITY||LS Mean Difference|2.22|STANDARD_ERROR_OF_MEAN|1.75||0.2038|TWO_SIDED|95.0|-1.21|5.65|||ANCOVA|||TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||5.65|-1.21|0.2038
70996775|NCT02528253|141501317|SUPERIORITY||LS Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|1.73||0.0644|TWO_SIDED|95.0|-0.19|6.59|||ANCOVA|||TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||6.59|-0.19|0.0644
70996776|NCT02528253|141501317|SUPERIORITY||LS Mean Difference|1.52|STANDARD_ERROR_OF_MEAN|1.72||0.3775|TWO_SIDED|95.0|-1.86|4.9|||ANCOVA|||TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||4.90|-1.86|0.3775
70996777|NCT02528253|141501317|SUPERIORITY||LS Mean Difference|1.45|STANDARD_ERROR_OF_MEAN|2.62||0.5806|TWO_SIDED|95.0|-3.7|6.6|||ANCOVA|||TSQM Effectiveness; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||6.60|-3.70|0.5806
70996778|NCT02528253|141501317|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|2.53||0.6084|TWO_SIDED|95.0|-3.68|6.27|||ANCOVA|||TSQM Effectiveness; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||6.27|-3.68|0.6084
70996779|NCT02528253|141501317|SUPERIORITY||LS Mean Difference|2.71|STANDARD_ERROR_OF_MEAN|6.95||0.6991|TWO_SIDED|95.0|-11.56|16.99|||ANCOVA|||TSQM Side Effects; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||16.99|-11.56|0.6991
70996780|NCT02528253|141501317|SUPERIORITY||LS Mean Difference|13.17|STANDARD_ERROR_OF_MEAN|5.6||0.0265|TWO_SIDED|95.0|1.66|24.68|||ANCOVA|||TSQM Side Effects; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||24.68|1.66|0.0265
70996781|NCT02528253|141501317|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.99||0.8795|TWO_SIDED|95.0|-3.61|4.21|||ANCOVA|||TSQM Convenience; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||4.21|-3.61|0.8795
70996782|NCT02528253|141501317|SUPERIORITY||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|1.92||0.2758|TWO_SIDED|95.0|-1.68|5.87|||ANCOVA|||TSQM Convenience; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||5.87|-1.68|0.2758
70996783|NCT02528253|141501317|SUPERIORITY||LS Mean Difference|3.54|STANDARD_ERROR_OF_MEAN|2.27||0.1197|TWO_SIDED|95.0|-0.92|8.0|||ANCOVA|||TSQM Global Satisfaction; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||8.00|-0.92|0.1197
71040919|NCT01525628|141590419|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|159.11|STANDARD_DEVIATION|57.8||0.8723|TWO_SIDED|90.0|111.06|227.93|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||227.93|111.06|0.8723
71040920|NCT01525628|141590419|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|259.57|STANDARD_DEVIATION|92.5||0.983|TWO_SIDED|90.0|150.65|447.21|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||447.21|150.65|0.9830
71040921|NCT01525628|141590419|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|163.95|STANDARD_DEVIATION|38.1||0.9689|TWO_SIDED|90.0|129.52|207.52|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||207.52|129.52|0.9689
71040922|NCT01525628|141590419|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|219.88|STANDARD_DEVIATION|70.4||0.9933|TWO_SIDED|90.0|153.84|314.26|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||314.26|153.84|0.9933
70996784|NCT02528253|141501317|SUPERIORITY||LS Mean Difference|3.93|STANDARD_ERROR_OF_MEAN|2.19||0.0743|TWO_SIDED|95.0|-0.39|8.24|||ANCOVA|||TSQM Global Satisfaction; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||8.24|-0.39|0.0743
70996785|NCT02514772|141501354|OTHER||Difference (%)|-1.9|||||TWO_SIDED|95.0|-20.6|16.9||||||||16.9|-20.6|
70996786|NCT02514772|141501355|OTHER||Difference (%)|-1.7|||||TWO_SIDED|95.0|-20.6|16.9||||||||16.9|-20.6|
70996787|NCT02514772|141501356|OTHER||Difference (%)|-1.9|||||TWO_SIDED|95.0|-21.2|17.6||||||||17.6|-21.2|
70996788|NCT02514772|141501357|OTHER||Mean Difference (Final Values)|-5.4|||||TWO_SIDED|95.0|-24.2|13.3||||||Incidence difference of infusion-related reactions, occurred on day of or on day after first infusion (i.e. on study day 1 or on study day 2).||13.3|-24.2|
70996789|NCT02514772|141501357|OTHER||Mean Difference (Final Values)|-5.3|||||TWO_SIDED|95.0|-24.5|13.6||||||Incidence difference of infusion-related reactions, occurred on day of or on day after second infusion (i.e. on study day 14 or on study day 15).||13.6|-24.5|
71040923|NCT01525628|141590419|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|214.4|STANDARD_DEVIATION|66.8||0.9865|TWO_SIDED|90.0|145.88|315.09|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||315.09|145.88|0.9865
71040924|NCT01525628|141590420|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|96.06|STANDARD_DEVIATION|14.2||0.0015|TWO_SIDED|90.0|87.77|105.13|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||105.13|87.77|0.0015
71040925|NCT01525628|141590420|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|85.41|STANDARD_DEVIATION|17.2||0.1617|TWO_SIDED|90.0|76.32|95.57|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||95.57|76.32|0.1617
71040926|NCT01525628|141590420|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|73.26|STANDARD_DEVIATION|17.5||0.893|TWO_SIDED|90.0|65.03|82.54|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||82.54|65.03|0.8930
71040927|NCT01525628|141590420|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|92.23|STANDARD_DEVIATION|10.5||0.0005|TWO_SIDED|90.0|86.67|98.13|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||98.13|86.67|0.0005
70996790|NCT02514772|141501357|OTHER||Mean Difference (Final Values)|-7.2|||||TWO_SIDED|95.0|-26.0|11.4||||||Incidence difference of infusion-related reactions overall on day(s) of or day(s) after either infusion (i.e. on day 1 or 2 and on day 14 or day 15).||11.4|-26.0|
70996791|NCT04295356|141501368|EQUIVALENCE|The 90% confidence interval of the ratio of geometric least squares means of Cmax was estimated to assess the PK similarity between CT-P17 AI and CT-P17 PFS (bioequivalence margin of 80% to 125%).|Ratio of geometric least squares means|102.6|||||TWO_SIDED|90.0|94.08|111.9|||ANCOVA|The stratification factors (gender \[male or female\], study center, and body weight as measured on Day -1) were included in ANCOVA model as covariates.||Equivalence test in Cmax between CT-P17 AI and CT-P17 PFS||111.90|94.08|
70996792|NCT04295356|141501369|EQUIVALENCE|The 90% confidence interval of the ratio of geometric least squares means of AUC0-inf was estimated to assess the PK similarity between CT-P17 AI and CT-P17 PFS (bioequivalence margin of 80% to 125%).|Ratio of geometric least squares means|103.64|||||TWO_SIDED|90.0|93.98|114.29|||ANCOVA|The stratification factors (gender \[male or female\], study center, and body weight as measured on Day -1) were included in ANCOVA model as covariates.||Equivalence test in AUC0-inf between CT-P17 AI and CT-P17 PFS||114.29|93.98|
70996793|NCT04295356|141501370|EQUIVALENCE|The 90% confidence interval of the ratio of geometric least squares means of AUC0-last was estimated to assess the PK similarity between CT-P17 AI and CT-P17 PFS (bioequivalence margin of 80% to 125%).|Ratio of geometric least squares means|105.36|||||TWO_SIDED|90.0|91.09|121.86|||ANCOVA|The stratification factors (gender \[male or female\], study center, and body weight as measured on Day -1) were included in ANCOVA model as covariates.||Equivalence test in AUC0-last between CT-P17 AI and CT-P17 PFS||121.86|91.09|
71040928|NCT01525628|141590420|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|73.93|STANDARD_DEVIATION|21.6||0.8646|TWO_SIDED|90.0|65.55|83.39|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||83.39|65.55|0.8646
71040929|NCT01525628|141590420|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|75.42|STANDARD_DEVIATION|16.4||0.8378|TWO_SIDED|90.0|68.15|83.45|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||83.45|68.15|0.8378
71100200|NCT03992872|141709004|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 1: Subject with Titer \>= 640"||||<0.0001
71100201|NCT03992872|141709004|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 22: Subject with Titer \>= 40"||||<0.0001
70996794|NCT01106391|141501378|SUPERIORITY_OR_OTHER_LEGACY||Rate of technical success (%)|90.0|||||TWO_SIDED|95.0|79.5|96.2|||||The 95% confidence interval was based on the exact confidence interval (Collett, 1991)|Since this was a feasibility study without comparisons, sample size was not determined based on statistical consideration. No formal hypothesis testing was performed either.||96.2|79.5|
70996795|NCT01106391|141501379|SUPERIORITY_OR_OTHER_LEGACY||Rate of achieved primary safety(%)|97.0|||||TWO_SIDED|95.0|88.1|99.6|||||The 95% confidence interval was based on the exact confidence interval (Collett, 1991)|Since this was a feasibility study without comparisons, sample size was not determined based on statistical consideration. No formal hypothesis testing was performed either.||99.6|88.1|
70996796|NCT04268004|141501388|OTHER|Chi-squared test was used to determine if study arm is associated with FP uptake.|||||=|0.64|||||||Chi-squared|df=(1, 19)||Chi-square test was used to determine if study arm is associated with FP uptake.||||=.64
70996797|NCT00830960|141501419|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference in PRU|-183.0|||<|0.0001|TWO_SIDED|95.0|-229.0|-137.0||"Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate denominator degrees of freedom for fixed effects. Invalid measurements excluded.||||-137|-229|<0.0001
70996798|NCT00830960|141501419|SUPERIORITY_OR_OTHER||LS Mean Difference in PRU|-139.0|||<|0.0001|TWO_SIDED|95.0|-177.0|-102.0||"Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate denominator degrees of freedom for fixed effects. Invalid measurements excluded.||||-102|-177|<0.0001
70996799|NCT00830960|141501420|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-57.0||||0.0058|TWO_SIDED|95.0|-97.0|-17.0||"P-value for 30 minutes post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-17|-97|0.0058
70996800|NCT00830960|141501420|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-35.0||||0.0365|TWO_SIDED|95.0|-68.0|-2.0||"P-value for 30 minutes post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel"|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-2|-68|0.0365
70996801|NCT00830960|141501420|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-68.0||||0.0004|TWO_SIDED|95.0|-104.0|-32.0||"P-value for 30 minutes post-LD Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-32|-104|0.0004
70996802|NCT00830960|141501420|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-160.0|||<|0.0001|TWO_SIDED|95.0|-211.0|-110.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-110|-211|<0.0001
70996803|NCT00830960|141501420|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-115.0|||<|0.0001|TWO_SIDED|95.0|-156.0|-73.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-73|-156|<0.0001
70996804|NCT00830960|141501420|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-171.0|||<|0.0001|TWO_SIDED|95.0|-216.0|-125.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-125|-216|<0.0001
71100202|NCT03992872|141709004|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 22: Subject with Titer \>= 160"||||<0.0001
71100203|NCT03992872|141709004|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 22: Subject with Titer \>=640"||||<0.0001
71100204|NCT03992872|141709004|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 29: Subject with Titer \>= 40"||||<0.0001
71100205|NCT03992872|141709004|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 29: Subjects with Titer \>= 160"||||<0.0001
71100206|NCT03992872|141709004|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 29 : Subjects with Titer \>=640"||||<0.0001
70996805|NCT00830960|141501420|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-212.0|||<|0.0001|TWO_SIDED|95.0|-259.0|-167.0||"P-value for 4 hours post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-167|-259|<0.0001
70996806|NCT00830960|141501421|SUPERIORITY_OR_OTHER||LS Mean Difference in PRU|-119.0|||<|0.0001|TWO_SIDED|95.0|-166.0|-73.0||"P-value for 30 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU was prasugrel - clopidogrel."|LS Mean Difference in PRU|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-73|-166|<0.0001
70996807|NCT00830960|141501421|SUPERIORITY_OR_OTHER||LS Mean Difference in PRU|-113.0|||<|0.0001|TWO_SIDED|95.0|-154.0|-73.0||"P-value for 90 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU was prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-73|-154|<0.0001
70996808|NCT00830960|141501421|SUPERIORITY_OR_OTHER||LS Mean Difference in PRU|-85.0|||<|0.0001|TWO_SIDED|95.0|-121.0|-48.0||"P-value for 90 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU was prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-48|-121|<0.0001
70996809|NCT00830960|141501421|SUPERIORITY_OR_OTHER||LS Mean Difference in PRU|-35.0||||0.0647|TWO_SIDED|95.0|-72.0|2.0||"P-value for 90 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU was prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||2|-72|0.0647
70996810|NCT00830960|141501421|SUPERIORITY_OR_OTHER||LS Mean Difference in PRU|-100.0|||<|0.0001|TWO_SIDED|95.0|-143.0|-57.0||"P-value for 90 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU was prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-57|-143|<0.0001
71040930|NCT01525628|141590421|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|98.17|STANDARD_DEVIATION|12.3||0.0005|TWO_SIDED|90.0|90.15|106.91|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||106.91|90.15|0.0005
71040931|NCT01525628|141590421|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|81.26|STANDARD_DEVIATION|11.7||0.3638|TWO_SIDED|90.0|75.19|87.82|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||87.82|75.19|0.3638
71040932|NCT01525628|141590421|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|70.93|STANDARD_DEVIATION|22.6||0.8975|TWO_SIDED|90.0|60.44|83.22|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||83.22|60.44|0.8975
71040933|NCT01525628|141590421|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|86.37|STANDARD_DEVIATION|18.1||0.1144|TWO_SIDED|90.0|77.62|96.11|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||96.11|77.62|0.1144
71040934|NCT01525628|141590421|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|64.66|STANDARD_DEVIATION|11.8||1|TWO_SIDED|90.0|60.42|69.2|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||69.20|60.42|1.0000
71040935|NCT01525628|141590421|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|63.75|STANDARD_DEVIATION|17.3||0.9988|TWO_SIDED|90.0|57.19|71.07|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||71.07|57.19|0.9988
70996811|NCT00830960|141501422|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|15.0||||0.0072|TWO_SIDED|95.0|4.0|27.0||"P-value for 30 minutes post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||27|4|0.0072
70996812|NCT00830960|141501422|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|9.0||||0.0647|TWO_SIDED|95.0|-1.0|18.0||"P-value for 30 minutes post-LD Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||18|-1|0.0647
70996813|NCT00830960|141501422|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|11.0||||0.0054|TWO_SIDED|95.0|3.0|19.0||"P-value for 30 minutes post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||19|3|0.0054
70996814|NCT00830960|141501422|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|51.0|||<|0.0001|TWO_SIDED|95.0|36.0|66.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||66|36|<0.0001
70996815|NCT00830960|141501422|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|36.0|||<|0.0001|TWO_SIDED|95.0|23.0|48.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||48|23|<0.0001
70996816|NCT00830960|141501422|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|49.0|||<|0.0001|TWO_SIDED|95.0|36.0|61.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||61|36|<0.0001
70996817|NCT00830960|141501422|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|62.0|||<|0.0001|TWO_SIDED|95.0|47.0|76.0||"P-value for 4 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||76|47|<0.0001
71040936|NCT01525628|141590422|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|144.78|STANDARD_DEVIATION|19.0||0.9749|TWO_SIDED|90.0|128.3|163.36|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||163.36|128.30|0.9749
71040937|NCT01525628|141590422|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|152.94|STANDARD_DEVIATION|26.8||0.9703|TWO_SIDED|90.0|128.6|181.89|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||181.89|128.60|0.9703
71040938|NCT01525628|141590422|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|102.99|STANDARD_DEVIATION|29.3||0.05|TWO_SIDED|90.0|84.85|124.99|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||124.99|84.85|0.0500
70996818|NCT00830960|141501422|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|48.0|||<|0.0001|TWO_SIDED|95.0|36.0|59.0||"P-value for 4 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||59|36|<0.0001
71040939|NCT01525628|141590422|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|124.22|STANDARD_DEVIATION|24.1||0.4697|TWO_SIDED|90.0|107.91|142.99|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||142.99|107.91|0.4697
71040940|NCT01525628|141590422|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|120.74|STANDARD_DEVIATION|19.2||0.2906|TWO_SIDED|90.0|108.47|134.38|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||134.38|108.47|0.2906
70996819|NCT00830960|141501422|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|56.0|||<|0.0001|TWO_SIDED|95.0|44.0|68.0||"P-value for 4 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||68|44|<0.0001
70996820|NCT00830960|141501423|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|38.0|||<|0.0001|TWO_SIDED|95.0|27.0|50.0||"P-value for 30 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||50|27|<0.0001
70996821|NCT00830960|141501423|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|32.0|||<|0.0001|TWO_SIDED|95.0|21.0|42.0||"P-value for 30 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||42|21|<0.0001
70996822|NCT00830960|141501423|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|17.0||||0.0026|TWO_SIDED|95.0|6.0|28.0||"P-value for 30 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||28|6|0.0026
70996823|NCT00830960|141501423|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|37.0|||<|0.0001|TWO_SIDED|95.0|24.0|50.0||"P-value for 30 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||50|24|<0.0001
70996824|NCT00830960|141501423|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|35.0||||0.0001|TWO_SIDED|95.0|18.0|52.0||"P-value for 90 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||52|18|0.0001
70996825|NCT00830960|141501423|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|28.0||||0.0005|TWO_SIDED|95.0|13.0|44.0||"P-value for 90 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||44|13|0.0005
70996826|NCT00830960|141501423|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|11.0||||0.1898|TWO_SIDED|95.0|-5.0|27.0||"P-value for 90 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||27|-5|0.1898
70996827|NCT00830960|141501423|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|32.0|||<|0.0001|TWO_SIDED|95.0|18.0|45.0||"P-value for 90 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||45|18|<0.0001
71040941|NCT01525628|141590422|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|93.95|STANDARD_DEVIATION|25.2||0.046|TWO_SIDED|90.0|80.33|109.86|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||109.86|80.33|0.0460
71040942|NCT01525628|141590423|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|151.66|STANDARD_DEVIATION|18.5||0.9941|TWO_SIDED|90.0|134.79|170.64|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||170.64|134.79|0.9941
71040943|NCT01525628|141590423|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|163.42|STANDARD_DEVIATION|26.0||0.9926|TWO_SIDED|90.0|137.91|193.64|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||193.64|137.91|0.9926
70996828|NCT00830960|141501425|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-110.0|||<|0.0001|TWO_SIDED|95.0|-143.0|-76.0||"Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-76|-143|<0.0001
70996829|NCT00830960|141501425|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-92.0|||<|0.0001|TWO_SIDED|95.0|-123.0|-60.0||"Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-60|-123|<0.0001
70996830|NCT00830960|141501425|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-51.0||||0.002|TWO_SIDED|95.0|-83.0|-19.0||"Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-19|-83|0.0020
70996831|NCT00830960|141501432|SUPERIORITY_OR_OTHER|||||||0.255||95.0|||||Fisher Exact|||||||0.255
70996832|NCT00830960|141501432|SUPERIORITY_OR_OTHER|||||||0.427||95.0|||||Fisher Exact|||||||0.427
70996833|NCT00830960|141501432|SUPERIORITY_OR_OTHER|||||||0.683||95.0|||||Fisher Exact|||||||0.683
70996834|NCT00830960|141501432|SUPERIORITY_OR_OTHER|||||||0.034||95.0|||||Fisher Exact|||||||0.034
70996835|NCT02855450|141501439|SUPERIORITY||Least square means difference|4.7||||0.04|TWO_SIDED|95.0|0.2|9.2|||ANCOVA|Analysis results are obtained from an ANCOVA with treatment as factor and baseline value as covariate.||These statistics refer to Day 7 and primary eye||9.2|0.2|0.040
70996836|NCT02855450|141501439|SUPERIORITY||least square mean difference|2.4||||0.457|TWO_SIDED|95.0|-4.1|9.0||Analysis results are obtained from an ANCOVA with treatment as factor and baseline value as covariate.|ANCOVA|||These statistics refer to Day 28 and primary eye||9.0|-4.1|0.457
70996837|NCT02855450|141501439|SUPERIORITY||least square mean difference|4.0||||0.283|TWO_SIDED|95.0|-3.5|11.5||Analysis results are obtained from an ANCOVA with treatment as factor and baseline value as covariate.|ANCOVA|||These statistics refer to Day 56 and primary eye||11.5|-3.5|0.283
70996838|NCT02855450|141501439|SUPERIORITY|Analysis results are obtained from an ANCOVA with treatment as factor and baseline value as covariate.|Least square means difference|3.5||||0.147|TWO_SIDED|95.0|-1.3|8.3|||ANCOVA|||These statistics refer to Day 7 and secondary eye||8.3|-1.3|0.147
70996839|NCT02855450|141501439|SUPERIORITY|Analysis results are obtained from an ANCOVA with treatment as factor and baseline value as covariate.|least square mean difference|3.0||||0.421|TWO_SIDED|95.0|-4.4|10.4|||ANCOVA|||These statistics refer to Day 28 and secondary eye||10.4|-4.4|0.421
70996840|NCT02855450|141501439|SUPERIORITY|Analysis results are obtained from an ANCOVA with treatment as factor and baseline value as covariate.|least square mean difference|4.3||||0.327|TWO_SIDED|95.0|-4.4|13.0|||ANCOVA|||These statistics refer to Day 56 and secondary eye||13.0|-4.4|0.327
70996841|NCT01376245|141501454|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.14|||<|0.001|TWO_SIDED|95.0|0.089|0.191|||Mixed Models Analysis|Restricted Maximum Likelihood (REML)-based repeated measures approach (MMRM)||||0.191|0.089|<0.001
70996842|NCT01376245|141501454|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.179|||<|0.001|TWO_SIDED|95.0|0.129|0.23|||Mixed Models Analysis|Restricted Maximum Likelihood (REML)-based repeated measures approach (MMRM)||||0.230|0.129|<0.001
70996843|NCT01376245|141501454|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.194|||<|0.001|TWO_SIDED|95.0|0.143|0.245|||Mixed Models Analysis|Restricted Maximum Likelihood (REML)-based repeated measures approach (MMRM)||||0.245|0.143|<0.001
70996844|NCT01357889|141501484|NON_INFERIORITY_OR_EQUIVALENCE|To establish BE, the 90% CI for the ratio of Process 3 (P3) to Process 2 (P2) geometric least squares means (LSMs) for AUC (0-inf) must have fallen within the BE limit of 0.8 and 1.25.|Ratio of Geometric LSMs (P3:P2)|0.937|||||TWO_SIDED|90.0|0.842|1.042|||ANOVA|||||1.042|0.842|
70996845|NCT01357889|141501485|NON_INFERIORITY_OR_EQUIVALENCE|To establish BE, the 90% CI for the ratio of Process 3:Process 2 geometric least squares means for Cmax must have fallen within the BE limit of 0.8 and 1.25.|Ratio of Geometric LSMs (P3:P2)|0.927|||||TWO_SIDED|90.0|0.813|1.056|||ANOVA|||||1.056|0.813|
70996846|NCT03970824|141501486|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|105.79|||||TWO_SIDED|90.0|97.19|115.16||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||115.16|97.19|
70996847|NCT03970824|141501486|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|92.63|||||TWO_SIDED|90.0|85.29|100.61||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||100.61|85.29|
70996848|NCT03970824|141501486|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|98.0|||||TWO_SIDED|90.0|90.06|106.63||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||106.63|90.06|
70996849|NCT03970824|141501487|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|107.3|||||TWO_SIDED|90.0|98.29|117.13||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||117.13|98.29|
70996850|NCT03970824|141501487|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|93.93|||||TWO_SIDED|90.0|86.08|102.5||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||102.50|86.08|
70996851|NCT03970824|141501487|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|100.79|||||TWO_SIDED|90.0|92.42|109.92||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||109.92|92.42|
70996852|NCT03970824|141501488|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|101.89|||||TWO_SIDED|90.0|95.33|108.89||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||108.89|95.33|
71040944|NCT01525628|141590423|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|98.14|STANDARD_DEVIATION|28.1||0.0392|TWO_SIDED|90.0|81.2|118.63|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||118.63|81.20|0.0392
71040945|NCT01525628|141590423|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|122.58|STANDARD_DEVIATION|37.2||0.4374|TWO_SIDED|90.0|99.15|151.55|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||151.55|99.15|0.4374
71040946|NCT01525628|141590423|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|130.44|STANDARD_DEVIATION|35.3||0.647|TWO_SIDED|90.0|107.57|158.18|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||158.18|107.57|0.6470
71040947|NCT01525628|141590423|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|87.77|STANDARD_DEVIATION|36.9||0.2372|TWO_SIDED|90.0|70.32|109.54|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||109.54|70.32|0.2372
71040948|NCT01525628|141590424|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|117.67|STANDARD_DEVIATION|15.6||0.1519|TWO_SIDED|90.0|106.49|130.0|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||130.00|106.49|0.1519
71040949|NCT01525628|141590424|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|117.01|STANDARD_DEVIATION|30.9||0.2827|TWO_SIDED|90.0|96.06|142.52|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day17 vs. Day 1||142.52|96.06|0.2827
71040950|NCT01525628|141590424|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|92.11|STANDARD_DEVIATION|32.6||0.1326|TWO_SIDED|90.0|74.38|114.07|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||114.07|74.38|0.1326
71100207|NCT03992872|141709005|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|23.12|||<|0.0001|TWO_SIDED|95.0|11.54|46.35||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 1: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||46.35|11.54|<0.0001
71040951|NCT01525628|141590424|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|95.55|STANDARD_DEVIATION|29.2||0.0432|TWO_SIDED|90.0|80.63|113.24|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||113.24|80.63|0.0432
71040952|NCT01525628|141590424|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|75.19|STANDARD_DEVIATION|30.3||0.7367|TWO_SIDED|90.0|63.64|88.82|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||88.82|63.64|0.7367
71040953|NCT01525628|141590424|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|70.14|STANDARD_DEVIATION|34.3||0.8547|TWO_SIDED|90.0|56.84|86.56|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||86.56|56.84|0.8547
71040954|NCT01525628|141590425|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|102.7|STANDARD_DEVIATION|45.9||0.1159|TWO_SIDED|90.0|77.89|135.39|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||135.39|77.89|0.1159
71040955|NCT01525628|141590425|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|99.99|STANDARD_DEVIATION|38.7||0.0651|TWO_SIDED|90.0|78.33|127.64|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||127.64|78.33|0.0651
71040956|NCT01525628|141590425|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|78.29|STANDARD_DEVIATION|34.3||0.5658|TWO_SIDED|90.0|62.5|98.07|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||98.07|62.50|0.5658
71040957|NCT01525628|141590425|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|108.25|STANDARD_DEVIATION|37.2||0.1286|TWO_SIDED|90.0|87.46|133.99|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||133.99|87.46|0.1286
71100208|NCT03992872|141709005|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|172.51|||<|0.0001|TWO_SIDED|95.0|106.6|279.19||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 22: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||279.19|106.60|<0.0001
71040958|NCT01525628|141590425|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|87.59|STANDARD_DEVIATION|31.8||0.1898|TWO_SIDED|90.0|73.56|104.3|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||104.30|73.56|0.1898
71040959|NCT01525628|141590425|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|78.42|STANDARD_DEVIATION|36.3||0.5575|TWO_SIDED|90.0|61.81|99.51|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||99.51|61.81|0.5575
71100209|NCT03992872|141709005|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|118.45|||<|0.0001|TWO_SIDED|95.0|61.76|227.16||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 29: Geometric mean ratio (prior alpha group over naive alpha group) and 95% confidence interval||227.16|61.76|<0.0001
70996853|NCT03970824|141501488|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|98.2|||||TWO_SIDED|90.0|91.91|104.92||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||104.92|91.91|
70996854|NCT03970824|141501488|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|100.05|||||TWO_SIDED|90.0|93.69|106.85||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||106.85|93.69|
71040960|NCT01992094|141590443|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT|1.0|||||TWO_SIDED|95.0|0.9|1.1|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain H1N1||1.1|0.9|
70996855|NCT00305604|141501500|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|0.81|<|0.001||95.0|-0.94|-0.47|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy (yes/no); age (\< 75/\>= 75 yr); baseline creatinine clearance (\< 50/\>= 50 mL/min)||||-0.47|-0.94|<0.001
70996856|NCT00305604|141501501|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.8|STANDARD_DEVIATION|45.0|<|0.001||95.0|-40.0|-13.5|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy (yes/no); age (\< 75/\>= 75 yr); baseline creatinine clearance (\< 50/\>= 50 mL/min)||||-13.5|-40.0|<0.001
70996857|NCT00305604|141501502|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-61.0|STANDARD_DEVIATION|63.0|<|0.001||95.0|-82.1|-40.0|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy (yes/no); age (\< 75/\>= 75 yr); baseline creatinine clearance (\< 50/\>= 50 mL/min)||||-40.0|-82.1|<0.001
70996858|NCT00305604|141501503|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.5|STANDARD_DEVIATION|25.2|<|0.001||95.0|-32.6|-14.4|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy (yes/no); age (\< 75/\>= 75 yr); baseline creatinine clearance (\< 50/\>= 50 mL/min)||||-14.4|-32.6|<0.001
70996859|NCT01248364|141501520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.18||0.279|TWO_SIDED|95.0|-0.16|0.55|||ANCOVA|Based on ANCOVA with terms for baseline FPG, diagnosis group, and baseline FPG by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||0.55|-0.16|0.2790
70996860|NCT01248364|141501521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.2||0.2438|TWO_SIDED|95.0|-0.16|0.62|||ANCOVA|Based on ANCOVA with terms for baseline FPG, diagnosis group and baseline FPG by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||0.62|-0.16|0.2438
70996861|NCT01248364|141501522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.75||0.6931|TWO_SIDED|95.0|-1.19|1.79|||ANCOVA|Based on ANCOVA with terms for baseline EPG fast, diagnosis group and baseline EPG fast by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||1.79|-1.19|0.6931
71040961|NCT01992094|141590443|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT|1.0|||||TWO_SIDED|95.0|0.9|1.1|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain H3N2||1.1|0.9|
71040962|NCT01992094|141590443|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT|0.9|||||TWO_SIDED|95.0|0.8|1.0|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain B1||1.0|0.8|
71040963|NCT01992094|141590443|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV2c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT|0.9|||||TWO_SIDED|95.0|0.9|1.0|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV2c, assessed in terms of ratios of GMT against influenza strain B2||1.0|0.9|
71100210|NCT03992872|141709006|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|"Day 22.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||<0.0001
70996862|NCT01248364|141501523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.84|STANDARD_ERROR_OF_MEAN|1.12||0.1028|TWO_SIDED|95.0|-0.38|4.07|||ANCOVA|Based on ANCOVA with terms for baseline EPG fast, diagnosis group and baseline EPG fast by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||4.07|-0.38|0.1028
70996863|NCT01248364|141501524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.48|STANDARD_ERROR_OF_MEAN|2.52||0.0326|TWO_SIDED|95.0|0.47|10.5|||ANCOVA|Based on ANCOVA with terms for baseline EPG AUC 5h, diagnosis group and baseline EPG AUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||10.50|0.47|0.0326
70996864|NCT01248364|141501525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|0.81||0.0552|TWO_SIDED|95.0|-3.2|0.04|||ANCOVA|Based on ANCOVA with terms for baseline PPG iAUC 5h, diagnosis group and baseline PPG iAUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||0.04|-3.20|0.0552
71100211|NCT03992872|141709006|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|"Day 29~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||<0.0001
71100212|NCT00889005|141709008|SUPERIORITY_OR_OTHER|||||||0.927|||||||ANOVA|||||||0.927
71100213|NCT02662582|141709105|SUPERIORITY||LSMean difference|-12.0||||0.734|TWO_SIDED|90.0|-71.2|47.2||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Least square means (LSMeans), LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||47.2|-71.2|0.734
70996865|NCT01248364|141501526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.99||0.7561|TWO_SIDED|95.0|-1.66|2.27|||ANCOVA|Based on ANCOVA with terms for baseline PPG iAUC 5h, diagnosis group and baseline PPG iAUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||2.27|-1.66|0.7561
71100214|NCT02662582|141709106|SUPERIORITY||LSMean Difference|-0.0219||||0.438|TWO_SIDED|90.0|-0.0694|0.0256||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0256|-0.0694|0.438
70996866|NCT01248364|141501527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.13|STANDARD_ERROR_OF_MEAN|1.89||0.1024|TWO_SIDED|95.0|-0.64|6.9|||ANCOVA|Based on ANCOVA with terms for baseline EPG AUC 5h, diagnosis group and baseline EPG AUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||6.90|-0.64|0.1024
70996867|NCT01248364|141501528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.31|STANDARD_ERROR_OF_MEAN|2.93||0.6576|TWO_SIDED|95.0|-4.53|7.14|||ANCOVA|Based on ANCOVA with terms for baseline EPG iAUC 5h, diagnosis group and baseline EPG iAUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||7.14|-4.53|0.6576
70996868|NCT01248364|141501529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.68|STANDARD_ERROR_OF_MEAN|3.38||0.2795|TWO_SIDED|95.0|-10.41|3.05|||ANCOVA|Based on ANCOVA with terms for baseline EPG iAUC 5h, diagnosis group and baseline EPG iAUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||3.05|-10.41|0.2795
70996869|NCT02431468|141501571|SUPERIORITY||Mean Difference (Net)|6.5|||<|0.1|TWO_SIDED|80.0||||LSM and two-sided 80% CI were provided for treatment group differences and estimated endpoint values. A true mean difference in change from baseline in the SIB (one-sided at α=0.10) of at least 6.5 points in favor of bryostatin groups was assumed.|t-test, 1 sided|||The primary statistical objective for efficacy was to estimate the effect of bryostatin on the mean change in the Severe Impairment Battery (SIB) after 12 weeks of treatment. A linear model was used for both estimation and significance testing. Primary analysis populations were defined as the Full Analysis Set (FAS) and the Completer Analysis Set (CAS)||||<0.1
70996870|NCT02431468|141501571|SUPERIORITY||Mean Difference (Net)|6.5|||<|0.1|TWO_SIDED|80.0|||||t-test, 1 sided|||Change from baseline in SIB in the Completer Analysis Set (CAS)||||<0.1
70996871|NCT00039741|141501587|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.13||0.26|TWO_SIDED|95.0|-0.41|0.11|||Interval regression|Adjusted for baseline HIV-1 RNA, age (\<3 years vs 3 years), origin (PACTG vs PENTA sites), and perinatal ART exposure versus no exposure.||||0.11|-0.41|0.26
70996872|NCT00039741|141501587|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.13||0.56|TWO_SIDED|95.0|-0.2|0.32|||Interval regression|Adjusted for baseline HIV-1 RNA, age (\<3 years vs 3 years), origin (PACTG vs PENTA sites), and perinatal ART exposure versus no exposure.||||0.32|-0.20|0.56
70996873|NCT00507416|141501616|SUPERIORITY_OR_OTHER|||||||0.458||||||The global difference among arms was based on the Wald test.|Wald test|||||||0.458
70996874|NCT02157506|141501634|SUPERIORITY||||||=|0.0059|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||=0.0059
70996875|NCT02157506|141501634|SUPERIORITY||||||=|0.0001|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0001
70996876|NCT02157506|141501634|SUPERIORITY||||||=|0.0062|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0062
70996877|NCT02157506|141501634|SUPERIORITY||||||=|0.0086|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0086
70996878|NCT02157506|141501635|SUPERIORITY||||||=|0.0076|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0076
70996879|NCT02157506|141501635|SUPERIORITY||||||=|0.0052|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0052
70996880|NCT02157506|141501635|SUPERIORITY||||||=|0.1064|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1064
70996881|NCT02157506|141501635|SUPERIORITY||||||=|0.1151|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1151
70996882|NCT02157506|141501636|SUPERIORITY||||||=|0.4241|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.4241
70996883|NCT02157506|141501636|SUPERIORITY||||||=|0.4035|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.4035
70996884|NCT02157506|141501636|SUPERIORITY||||||=|0.8308|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.8308
70996885|NCT02157506|141501636|SUPERIORITY||||||=|0.118|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1180
70996886|NCT02157506|141501637|SUPERIORITY||||||=|0.0048|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0048
70996887|NCT02157506|141501637|SUPERIORITY||||||=|0.0022|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0022
70996888|NCT02157506|141501637|SUPERIORITY||||||=|0.0045|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0045
71100215|NCT02662582|141709106|SUPERIORITY||LSMean Difference|-0.0325||||0.114|TWO_SIDED|90.0|-0.0663|0.0014||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0014|-0.0663|0.114
71100216|NCT02662582|141709107|SUPERIORITY||LSMean difference|0.75||||0.612|TWO_SIDED|90.0|-1.75|3.24||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||3.24|-1.75|0.612
70996889|NCT02157506|141501637|SUPERIORITY||||||=|0.0294|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0294
70996890|NCT02157506|141501638|SUPERIORITY||||||=|0.2022|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.2022
70996891|NCT02157506|141501638|SUPERIORITY||||||=|0.0658|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0658
70996892|NCT02157506|141501638|SUPERIORITY||||||=|0.0741|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0741
70996893|NCT02157506|141501638|SUPERIORITY||||||=|0.0497|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0497
70996894|NCT02157506|141501639|SUPERIORITY||||||=|0.1842|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1842
70996895|NCT02157506|141501639|SUPERIORITY||||||=|0.3328|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.3328
70996896|NCT02157506|141501639|SUPERIORITY||||||=|0.1465|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1465
70996897|NCT02157506|141501639|SUPERIORITY||||||=|0.2799|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.2799
70996898|NCT02157506|141501640|SUPERIORITY||||||=|0.2499|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.2499
70996899|NCT02157506|141501640|SUPERIORITY||||||=|0.8281|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.8281
70996900|NCT02157506|141501640|SUPERIORITY||||||=|0.4121|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.4121
70996901|NCT02157506|141501640|SUPERIORITY||||||=|0.8592|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.8592
70996902|NCT02157506|141501641|SUPERIORITY||||||=|0.1391|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1391
70996903|NCT02157506|141501641|SUPERIORITY||||||=|0.1724|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1724
70996904|NCT02157506|141501641|SUPERIORITY||||||=|0.1245|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1245
70996905|NCT02157506|141501641|SUPERIORITY||||||=|0.169|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1690
70996906|NCT02157506|141501642|SUPERIORITY||||||=|0.4936|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.4936
70996907|NCT02157506|141501642|SUPERIORITY||||||=|0.992|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.9920
70996908|NCT02157506|141501642|SUPERIORITY||||||=|0.2789|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.2789
70996909|NCT02157506|141501642|SUPERIORITY||||||=|0.91|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.9100
70996910|NCT01021813|141501650|SUPERIORITY_OR_OTHER||Difference in Percentage|0.4|||||TWO_SIDED|95.0|-1.1|1.4|||Miettinen & Nurminen Method.|||The method of Miettinen and Nurminen was used to construct the confidence interval for the difference in the percentage of participants with any sleep paralysis AEs between the Suvorexant group and Placebo group .||1.4|-1.1|
70996911|NCT01021813|141501651|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2||||0.482|TWO_SIDED|95.0|-1.3|1.1|||Miettinen & Nurminen Method.|||The method of Miettinen and Nurminen was used to construct the confidence interval for the difference in the percentage of participants with any complex sleep-related behaviors AEs between the Suvorexant group and Placebo group.||1.1|-1.3|0.482
70996912|NCT01021813|141501652|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.8||||0.508|TWO_SIDED|95.0|-3.9|1.5|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and construct the confidence interval for the difference in the percentage of participants with any falls AEs between the Suvorexant group and Placebo group.||1.5|-3.9|0.508
70996913|NCT01021813|141501653|SUPERIORITY_OR_OTHER||Difference in Percentage of AEs|0.8||||0.159|TWO_SIDED|95.0|-0.7|2.0|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and construct the confidence interval for the difference in the percentage of participants with any suicidal ideation/behavior AEs considered an ECI between the Suvorexant group and Placebo group.||2.0|-0.7|0.159
70996914|NCT01021813|141501654|SUPERIORITY_OR_OTHER||Difference in Percentage|0.8||||0.159|TWO_SIDED|95.0|-0.7|2.0|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and construct the confidence interval for the difference in the percentage of participants with any Hypnagogic/hypnopompic hallucinations AEs between the Suvorexant group and Placebo group.||2.0|-0.7|0.159
71100217|NCT02662582|141709107|SUPERIORITY||LSMean difference|0.29||||0.789|TWO_SIDED|90.0|-1.55|2.14||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||2.14|-1.55|0.789
70996915|NCT01021813|141501655|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.4||||0.767|TWO_SIDED|95.0|-3.8|2.2|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and construct the confidence interval for the difference in the percentage of participants with any selected AEs associated with potential abuse between the Suvorexant group and Placebo group.||2.2|-3.8|0.767
70996916|NCT01021813|141501656|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 1|-0.81||||0.567|TWO_SIDED|95.0|-5.1|3.1|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with withdrawal symptoms during Night 1 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Suvorexant (DB Treatment)/Placebo (DB Discontinuation) group.||3.1|-5.1|0.567
70996917|NCT01021813|141501656|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 2|-2.4||||0.185|TWO_SIDED|95.0|-7.3|1.6|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with withdrawal symptoms during Night 2 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Suvorexant (DB Treatment)/Placebo (DB Discontinuation) group.||1.6|-7.3|0.185
70996918|NCT01021813|141501656|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 3|-0.78||||0.68|TWO_SIDED|95.0|-5.6|3.9|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with withdrawal symptoms during Night 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Suvorexant (DB Treatment)/Placebo (DB Discontinuation) group.||3.9|-5.6|0.680
70996919|NCT01021813|141501656|SUPERIORITY_OR_OTHER||Difference in Percentage: Across Nights|0.0||||1|TWO_SIDED|95.0|-6.4|6.4|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with withdrawal symptoms across Nights 1, 2, and 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Suvorexant (DB Treatment)/Placebo (DB Discontinuation) group.||6.4|-6.4|1.000
70996920|NCT01021813|141501657|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 1|5.03||||0.365|TWO_SIDED|95.0|-5.8|15.8|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTST rebound effects during Night 1 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||15.8|-5.8|0.365
70996921|NCT01021813|141501657|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 2|8.72||||0.109|TWO_SIDED|95.0|-2.0|19.2|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTST rebound effects during Night 2 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||19.2|-2.0|0.109
71040964|NCT01992094|141590444|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference between seroconversion rates|-0.5|||||TWO_SIDED|95.0|-5.3|4.2|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain H1N1||4.2|-5.3|
71100218|NCT02662582|141709108|SUPERIORITY||LSMean difference|0.72||||0.225|TWO_SIDED|90.0|-0.26|1.7||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.70|-0.26|0.225
70996922|NCT01021813|141501657|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 3|6.02||||0.287|TWO_SIDED|95.0|-5.1|16.9|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTST rebound effects during Night 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||16.9|-5.1|0.287
70996923|NCT01021813|141501657|SUPERIORITY_OR_OTHER||Difference in Percentage:Night 1, 2 or 3|10.82||||0.057|TWO_SIDED|95.0|-0.3|21.7|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTST rebound effects during Nights 1, 2, or 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||21.7|-0.3|0.057
71040965|NCT01992094|141590444|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference between seroconversion rates|-2.7|||||TWO_SIDED|95.0|-7.2|1.9|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strainH3N2||1.9|-7.2|
71100219|NCT02662582|141709108|SUPERIORITY||LSMean difference|0.92||||0.064||90.0|0.11|1.174||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.174|0.11|0.064
70996924|NCT01021813|141501658|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 1|4.46||||0.386|TWO_SIDED|95.0|-5.7|14.5|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTSO rebound effects during Night 1 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||14.5|-5.7|0.386
70996925|NCT01021813|141501658|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 2|5.31||||0.311|TWO_SIDED|95.0|-5.0|15.5|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTSO rebound effects during Night 2 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||15.5|-5.0|0.311
70996926|NCT01021813|141501658|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 3|4.96||||0.351|TWO_SIDED|95.0|-5.5|15.3|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTSO rebound effects during Night 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||15.3|-5.5|0.351
70996927|NCT01021813|141501658|SUPERIORITY_OR_OTHER||Difference in Percentage:Night 1, 2 or 3|4.58||||0.409|TWO_SIDED|95.0|-6.3|15.3|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTSO rebound effects during Nights 1, 2, or 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||15.3|-6.3|0.409
70996928|NCT01021813|141501659|SUPERIORITY_OR_OTHER||Difference in LS Means: Month 1|22.7|||<|0.0001|TWO_SIDED|95.0|16.4|29.0||To account for multiplicity, Hochberg's procedure was used to control the overall Type I error rate at the 5% level.|Longitudinal Data Analysis|||A Longitudinal Data Analysis Model was used to test the difference in LS mean change from baseline in sTSTm for Month 1 (Average of Weeks 1, 2, 3, 4) in the Suvorexant group vs. the Placebo group.||29.0|16.4|<0.0001
70996929|NCT01021813|141501660|SUPERIORITY_OR_OTHER||Difference in LS Means: Month 1|-9.5||||0.0002|TWO_SIDED|95.0|-14.6|-4.5||To account for multiplicity, Hochberg's procedure was used to control the overall Type I error rate at the 5% level.|Longitudinal Data Analysis|||A Longitudinal Data Analysis Model was used to test the difference in LS mean change from baseline in sTSOm for Month 1 (Average of Weeks 1, 2, 3, 4) in the Suvorexant group vs. the Placebo group.||-4.5|-14.6|0.0002
70996930|NCT00764478|141501662|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-3.5|STANDARD_ERROR_OF_MEAN|1.41||0.0136|TWO_SIDED|95.0|-6.3|-0.7||Adjusted p-value from graphical approach to control Type 1 error rate among primary and secondary hypotheses|MMRM||Asenapine 5 mg BID minus Placebo BID|||-0.7|-6.3|0.0136
70996931|NCT00764478|141501662|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-4.0|STANDARD_ERROR_OF_MEAN|1.43||0.01|TWO_SIDED|95.0|-6.9|-1.2||Adjusted p-value from graphical approach to control Type 1 error rate among primary and secondary hypotheses|MMRM||Asenapine 10 mg BID minus Placebo BID|||-1.2|-6.9|0.0100
70996932|NCT00764478|141501663|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.16||0.01|TWO_SIDED|95.0|-0.8|-0.2||Adjusted p-value from Hochberg's method for testing two secondary efficacy hypotheses|MMRM||Asenapine 5 mg BID minus Placebo BID|||-0.2|-0.8|0.0100
70996933|NCT00764478|141501663|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.16||0.0052|TWO_SIDED|95.0|-0.9|-0.2||Adjusted p-value from Hochberg's method for testing two secondary efficacy hypotheses|MMRM||Asenapine 10 mg BID minus Placebo BID|||-0.2|-0.9|0.0052
70996934|NCT00764478|141501664|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5352||||||Overall adjusted p-value from Hochberg's method for testing two secondary efficacy hypotheses|Cochran-Mantel-Haenszel|||||||0.5352
71040966|NCT01992094|141590444|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference between seroconversion rates|-1.8|||||TWO_SIDED|95.0|-6.2|2.8|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain B1||2.8|-6.2|
70996935|NCT00764478|141501664|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4274||||||Overall adjusted p-value from Hochberg's method for testing two secondary efficacy hypotheses|Cochran-Mantel-Haenszel|||||||0.4274
70996936|NCT00764478|141501665|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-2.7|STANDARD_ERROR_OF_MEAN|0.78||0.0007|TWO_SIDED|95.0|-4.2|-1.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 2||-1.1|-4.2|0.0007
70996937|NCT00764478|141501665|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.9|STANDARD_ERROR_OF_MEAN|0.79||0.0003|TWO_SIDED|95.0|-4.4|-1.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 2||-1.3|-4.4|0.0003
70996938|NCT00764478|141501665|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.6|STANDARD_ERROR_OF_MEAN|0.91|<|0.0001|TWO_SIDED|95.0|-5.4|-1.8|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||-1.8|-5.4|<0.0001
70996939|NCT00764478|141501665|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.7|STANDARD_ERROR_OF_MEAN|0.92|<|0.0001|TWO_SIDED|95.0|-5.5|-1.9|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 4||-1.9|-5.5|<0.0001
70996940|NCT00764478|141501665|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.5|STANDARD_ERROR_OF_MEAN|1.12||0.0021|TWO_SIDED|95.0|-5.7|-1.3|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-1.3|-5.7|0.0021
70996941|NCT00764478|141501665|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-4.2|STANDARD_ERROR_OF_MEAN|1.13||0.0002|TWO_SIDED|95.0|-6.4|-2.0|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||-2.0|-6.4|0.0002
70996942|NCT00764478|141501665|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.8|STANDARD_ERROR_OF_MEAN|1.35||0.1907|TWO_SIDED|95.0|-4.4|0.9|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.9|-4.4|0.1907
70996943|NCT00764478|141501665|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.1|STANDARD_ERROR_OF_MEAN|1.37||0.0238|TWO_SIDED|95.0|-5.8|-0.4|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.4|-5.8|0.0238
70996944|NCT00764478|141501666|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2922|||||||Cochran-Mantel-Haenszel|||Day 2||||0.2922
70996945|NCT00764478|141501666|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1001|||||||Cochran-Mantel-Haenszel|||Day 2||||0.1001
70996946|NCT00764478|141501666|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011|||||||Cochran-Mantel-Haenszel|||Day 4||||0.0011
70996947|NCT00764478|141501666|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011|||||||Cochran-Mantel-Haenszel|||Day 4||||0.0011
70996948|NCT00764478|141501666|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0194|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0194
70996949|NCT00764478|141501666|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0841|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0841
70996950|NCT00764478|141501666|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4858|||||||Cochran-Mantel-Haenszel|||Day 14||||0.4858
70996951|NCT00764478|141501666|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2496|||||||Cochran-Mantel-Haenszel|||Day 14||||0.2496
70996952|NCT00764478|141501667|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2912|||||||Cochran-Mantel-Haenszel|||||||0.2912
70996953|NCT00764478|141501667|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1151|||||||Cochran-Mantel-Haenszel|||||||0.1151
70996954|NCT00764478|141501669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019|||||||ANCOVA|||Day 7||||0.0019
70996955|NCT00764478|141501669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0045|||||||ANCOVA|||Day 7||||0.0045
70996956|NCT00764478|141501669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0112|||||||ANCOVA|||Day 21||||0.0112
70996957|NCT00764478|141501669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0021|||||||ANCOVA|||Day 21||||0.0021
70996958|NCT00764478|141501670|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.4|-0.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 2||-0.1|-0.4|<0.0001
70996959|NCT00764478|141501670|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.0076|TWO_SIDED|95.0|-0.3|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 2||-0.1|-0.3|0.0076
70996960|NCT00764478|141501670|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0004|TWO_SIDED|95.0|-0.6|-0.2|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||-0.2|-0.6|0.0004
70996961|NCT00764478|141501670|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.004|TWO_SIDED|95.0|-0.5|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 4||-0.1|-0.5|0.0040
71040967|NCT01992094|141590444|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV2c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference between seroconversion rates|-4.4|||||TWO_SIDED|95.0|-8.9|0.2|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV2c in terms of differences in seroconversion rates against influenza strain B2||0.2|-8.9|
70996962|NCT00764478|141501670|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0061|TWO_SIDED|95.0|-0.6|-0.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-0.1|-0.6|0.0061
70996963|NCT00764478|141501670|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0031|TWO_SIDED|95.0|-0.6|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||-0.1|-0.6|0.0031
70996964|NCT00764478|141501670|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1086|TWO_SIDED|95.0|-0.5|0.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.1|-0.5|0.1086
70996965|NCT00764478|141501670|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.0376|TWO_SIDED|95.0|-0.6|0.0|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.0|-0.6|0.0376
70996966|NCT00764478|141501671|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005|||||||ANCOVA|||Day 2||||0.0005
70996967|NCT00764478|141501671|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0026|||||||ANCOVA|||Day 2||||0.0026
70996968|NCT00764478|141501671|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007|||||||ANCOVA|||Day 4||||0.0007
70996969|NCT00764478|141501671|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|||||||ANCOVA|||Day 4||||0.0002
71040968|NCT01992094|141590450|NON_INFERIORITY_OR_EQUIVALENCE|The upper bound of the 2-sided 95% CI for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody should not exceed the superiority margin of 1.|Ratios of GMT|0.6|||||TWO_SIDED|95.0|0.6|0.7||||||Superiority of immune responses of QIVc to TIV1c in terms of ratios of GMT against influenza strain B2||0.7|0.6|
70996970|NCT00764478|141501671|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0387|||||||ANCOVA|||Day 7||||0.0387
70996971|NCT00764478|141501671|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0059|||||||ANCOVA|||Day 7||||0.0059
70996972|NCT00764478|141501671|SUPERIORITY_OR_OTHER_LEGACY|||||||0.311|||||||ANCOVA|||Day 14||||0.3110
70996973|NCT00764478|141501671|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0613|||||||ANCOVA|||Day 14||||0.0613
70996974|NCT00764478|141501671|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064|||||||ANCOVA|||Day 21||||0.0640
70996975|NCT00764478|141501671|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0139|||||||ANCOVA|||Day 21||||0.0139
70996976|NCT00764478|141501672|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9708|||||||ANCOVA|||Day 2||||0.9708
70996977|NCT00764478|141501672|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7891|||||||ANCOVA|||Day 2||||0.7891
70996978|NCT00764478|141501672|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5222|||||||ANCOVA|||Day 4||||0.5222
70996979|NCT00764478|141501672|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8686|||||||ANCOVA|||Day 4||||0.8686
70996980|NCT00764478|141501672|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0696|||||||ANCOVA|||Day 7||||0.0696
70996981|NCT00764478|141501672|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0049|||||||ANCOVA|||Day 7||||0.0049
70996982|NCT00764478|141501672|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0196|||||||ANCOVA|||Day 14||||0.0196
70996983|NCT00764478|141501672|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0032|||||||ANCOVA|||Day 14||||0.0032
70996984|NCT00764478|141501672|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0061|||||||ANCOVA|||Day 21||||0.0061
70996985|NCT00764478|141501672|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012|||||||ANCOVA|||Day 21||||0.0012
70996986|NCT00764478|141501673|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0147|||||||Cochran-Mantel-Haenszel|||Day 2||||0.0147
70996987|NCT00764478|141501673|SUPERIORITY_OR_OTHER_LEGACY|||||||0.072|||||||Cochran-Mantel-Haenszel|||Day 2||||0.0720
70996988|NCT00764478|141501673|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1213|||||||Cochran-Mantel-Haenszel|||Day 4||||0.1213
70996989|NCT00764478|141501673|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0588|||||||Cochran-Mantel-Haenszel|||Day 4||||0.0588
70996990|NCT00764478|141501673|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0200
70996991|NCT00764478|141501673|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0017
70996992|NCT00764478|141501673|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2401|||||||Cochran-Mantel-Haenszel|||Day 14||||0.2401
70996993|NCT00764478|141501673|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009|||||||Cochran-Mantel-Haenszel|||Day 14||||0.0009
70996994|NCT00764478|141501673|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0525|||||||Cochran-Mantel-Haenszel|||Day 21||||0.0525
70996995|NCT00764478|141501673|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0025|||||||Cochran-Mantel-Haenszel|||Day 21||||0.0025
70996996|NCT00764478|141501674|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0377|||||||Cochran-Mantel-Haenszel|||Day 2||||0.0377
70996997|NCT00764478|141501674|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0771|||||||Cochran-Mantel-Haenszel|||Day 2||||0.0771
70996998|NCT00764478|141501674|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1264|||||||Cochran-Mantel-Haenszel|||Day 4||||0.1264
70996999|NCT00764478|141501674|SUPERIORITY_OR_OTHER_LEGACY|||||||0.028|||||||Cochran-Mantel-Haenszel|||Day 4||||0.0280
71040969|NCT01992094|141590451|NON_INFERIORITY_OR_EQUIVALENCE|The upper bound of the 2-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c or TIV2c - % seroconversion QIVc) for HI antibody should not exceed the margin of 0 points.|Difference between seroconversion rates|-19.4|||||TWO_SIDED|95.0|-23.2|-15.5||||||Superiority of immune responses of QIVc to TIV1c in terms of seroconversion rates against influenza strain B2||-15.5|-23.2|
70997000|NCT00764478|141501674|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0583|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0583
70997001|NCT00764478|141501674|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0021|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0021
70997002|NCT00764478|141501674|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0866|||||||Cochran-Mantel-Haenszel|||Day 14||||0.0866
70997003|NCT00764478|141501674|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0048|||||||Cochran-Mantel-Haenszel|||Day 14||||0.0048
70997004|NCT00764478|141501674|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0147|||||||Cochran-Mantel-Haenszel|||Day 21||||0.0147
70997005|NCT00764478|141501674|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||Cochran-Mantel-Haenszel|||Day 21||||0.0030
70997006|NCT00764478|141501675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0104|||||||Cochran-Mantel-Haenszel|||Day 2||||0.0104
70997007|NCT00764478|141501675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005|||||||Cochran-Mantel-Haenszel|||Day 2||||0.0005
70997008|NCT00764478|141501675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0692|||||||Cochran-Mantel-Haenszel|||Day 4||||0.0692
70997009|NCT00764478|141501675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0128|||||||Cochran-Mantel-Haenszel|||Day 4||||0.0128
70997010|NCT00764478|141501675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0809|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0809
70997011|NCT00764478|141501675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0260
70997012|NCT00764478|141501675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2576|||||||Cochran-Mantel-Haenszel|||Day 14||||0.2576
70997013|NCT00764478|141501675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0077|||||||Cochran-Mantel-Haenszel|||Day 14||||0.0077
70997014|NCT00764478|141501675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.396|||||||Cochran-Mantel-Haenszel|||Day 21||||0.3960
70997015|NCT00764478|141501675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0141|||||||Cochran-Mantel-Haenszel|||Day 21||||0.0141
70997016|NCT00764478|141501676|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-3.0|STANDARD_ERROR_OF_MEAN|1.06||0.0056|TWO_SIDED|95.0|-5.1|-0.9|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-0.9|-5.1|0.0056
70997017|NCT00764478|141501676|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.9|STANDARD_ERROR_OF_MEAN|1.08||0.0068|TWO_SIDED|95.0|-5.0|-0.8|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||-0.8|-5.0|0.0068
70997018|NCT00764478|141501676|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.4|STANDARD_ERROR_OF_MEAN|1.33||0.0743|TWO_SIDED|95.0|-5.0|0.2|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.2|-5.0|0.0743
70997019|NCT00764478|141501676|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.2|STANDARD_ERROR_OF_MEAN|1.35||0.0177|TWO_SIDED|95.0|-5.9|-0.6|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.6|-5.9|0.0177
70997020|NCT00764478|141501676|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.8|STANDARD_ERROR_OF_MEAN|1.41||0.0081|TWO_SIDED|95.0|-6.6|-1.0|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||-1.0|-6.6|0.0081
70997021|NCT00764478|141501676|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.2|STANDARD_ERROR_OF_MEAN|1.43||0.0247|TWO_SIDED|95.0|-6.1|-0.4|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||-0.4|-6.1|0.0247
70997022|NCT00764478|141501677|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9808|TWO_SIDED|95.0|-0.6|0.6|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.6|-0.6|0.9808
70997023|NCT00764478|141501677|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.283|TWO_SIDED|95.0|-0.9|0.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||0.3|-0.9|0.2830
70997024|NCT00764478|141501677|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.32||0.9751|TWO_SIDED|95.0|-0.6|0.6|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.6|-0.6|0.9751
70997025|NCT00764478|141501677|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.33||0.7879|TWO_SIDED|95.0|-0.6|0.7|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||0.7|-0.6|0.7879
70997026|NCT00764478|141501677|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.38||0.9654|TWO_SIDED|95.0|-0.8|0.7|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.7|-0.8|0.9654
70997027|NCT00764478|141501677|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.39||0.3917|TWO_SIDED|95.0|-0.4|1.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||1.1|-0.4|0.3917
70997028|NCT00764478|141501678|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-1.0|STANDARD_ERROR_OF_MEAN|0.41||0.012|TWO_SIDED|95.0|-1.8|-0.2|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-0.2|-1.8|0.0120
71040970|NCT01992094|141590452|NON_INFERIORITY_OR_EQUIVALENCE|The upper bound of the 2-sided 95% CI for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody should not exceed the superiority margin of 1.|Ratios of GMT|0.5|||||TWO_SIDED|95.0|0.5|0.5||||||Superiority of immune responses of QIVc to TIV2c in terms of ratios of GMT against influenza strain B1||0.5|0.5|
71040971|NCT01992094|141590453|NON_INFERIORITY_OR_EQUIVALENCE|The upper bound of the 2-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c or TIV2c - %seroconversion QIVc) for HI antibody should not exceed the margin of 0 points.|Difference between seroconversion rates|-21.7|||||TWO_SIDED|95.0|-25.5|-17.7||||||Superiority of immune responses of QIVc to TIV2c in terms of seroconversion rates against influenza strain B1||-17.7|-25.5|
71040972|NCT01214239|141590456|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.71|-0.28|||ANCOVA|||||-0.28|-0.71|<0.0001
71040973|NCT01214239|141590457|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.383|STANDARD_ERROR_OF_MEAN|0.074|<|0.0001||95.0|-0.527|-0.238|||ANCOVA|||||-0.238|-0.527|<0.0001
70997029|NCT00764478|141501678|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.4|STANDARD_ERROR_OF_MEAN|0.42||0.0011|TWO_SIDED|95.0|-2.2|-0.5|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||-0.5|-2.2|0.0011
70997030|NCT00764478|141501678|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.51||0.6885|TWO_SIDED|95.0|-1.2|0.8|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.8|-1.2|0.6885
70997031|NCT00764478|141501678|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.52||0.0398|TWO_SIDED|95.0|-2.1|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.1|-2.1|0.0398
70997032|NCT00764478|141501678|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.51||0.0258|TWO_SIDED|95.0|-2.1|-0.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||-0.1|-2.1|0.0258
70997033|NCT00764478|141501678|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.5|STANDARD_ERROR_OF_MEAN|0.51||0.0031|TWO_SIDED|95.0|-2.5|-0.5|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||-0.5|-2.5|0.0031
70997034|NCT00764478|141501679|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-1.9|STANDARD_ERROR_OF_MEAN|0.64||0.0033|TWO_SIDED|95.0|-3.2|-0.6|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-0.6|-3.2|0.0033
70997035|NCT00764478|141501679|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|0.65||0.0622|TWO_SIDED|95.0|-2.5|0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||0.1|-2.5|0.0622
70997036|NCT00764478|141501679|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.1|STANDARD_ERROR_OF_MEAN|0.79||0.0083|TWO_SIDED|95.0|-3.6|-0.5|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||-0.5|-3.6|0.0083
70997037|NCT00764478|141501679|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.2|STANDARD_ERROR_OF_MEAN|0.8||0.0064|TWO_SIDED|95.0|-3.8|-0.6|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.6|-3.8|0.0064
70997038|NCT00764478|141501679|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.6|STANDARD_ERROR_OF_MEAN|0.84||0.0022|TWO_SIDED|95.0|-4.3|-0.9|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||-0.9|-4.3|0.0022
70997039|NCT00764478|141501679|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.0|STANDARD_ERROR_OF_MEAN|0.85||0.0196|TWO_SIDED|95.0|-3.7|-0.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||-0.3|-3.7|0.0196
71040974|NCT01214239|141590458|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.677|-0.323|||ANCOVA|||||-0.323|-0.677|<0.0001
71040975|NCT01214239|141590459|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.512|STANDARD_ERROR_OF_MEAN|0.098|<|0.0001||95.0|-0.705|-0.318|||ANCOVA|||||-0.318|-0.705|<0.0001
71040976|NCT01214239|141590460|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.12||0.0001||95.0|-0.69|-0.23|||ANCOVA|||||-0.23|-0.69|0.0001
71040977|NCT01214239|141590461|SUPERIORITY_OR_OTHER||Adjusted mean difference|-11.2|STANDARD_ERROR_OF_MEAN|3.1||0.0003||95.0|-17.2|-5.2|||ANCOVA|||||-5.2|-17.2|0.0003
70997040|NCT00764478|141501680|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.1883|TWO_SIDED|95.0|-1.3|0.3|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.3|-1.3|0.1883
70997041|NCT00764478|141501680|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.4||0.1684|TWO_SIDED|95.0|-1.3|0.2|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||0.2|-1.3|0.1684
71040978|NCT01214239|141590462|SUPERIORITY_OR_OTHER||Adjusted mean difference|-8.8|STANDARD_ERROR_OF_MEAN|3.3||0.0086||95.0|-15.4|-2.3|||ANCOVA|||||-2.3|-15.4|0.0086
71040979|NCT01214239|141590463|SUPERIORITY_OR_OTHER||Adjusted mean difference|-9.5|STANDARD_ERROR_OF_MEAN|3.8||0.0135||95.0|-17.0|-2.0|||ANCOVA|||||-2.0|-17.0|0.0135
71040980|NCT01214239|141590464|SUPERIORITY_OR_OTHER||Adjusted mean difference|-9.6|STANDARD_ERROR_OF_MEAN|3.8||0.0113||95.0|-17.1|-2.2|||ANCOVA|||||-2.2|-17.1|0.0113
71040981|NCT01214239|141590466|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.552||||0.0021||95.0|1.407|4.629|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication||Comparison by odds ratio for the patients with a baseline HbA1c \>= 7.0%||4.629|1.407|0.0021
71040982|NCT01214239|141590468|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.583||||0.25||95.0|0.724|3.46|||Regression, Logistic|||Comparison by odds ratio for the patients with a baseline HbA1c \>= 6.5%||3.46|0.724|0.2500
71040983|NCT01214239|141590469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.527||||0.0005||95.0|1.494|4.276|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication||||4.276|1.494|0.0005
70997042|NCT00764478|141501680|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.46||0.9522|TWO_SIDED|95.0|-0.9|0.9|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.9|-0.9|0.9522
70997043|NCT00764478|141501680|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.47||0.0514|TWO_SIDED|95.0|-1.8|0.0|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||0.0|-1.8|0.0514
70997044|NCT00764478|141501680|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.47||0.0531|TWO_SIDED|95.0|-1.8|0.0|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.0|-1.8|0.0531
70997045|NCT00764478|141501680|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.3|STANDARD_ERROR_OF_MEAN|0.48||0.0078|TWO_SIDED|95.0|-2.2|-0.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||-0.3|-2.2|0.0078
70997046|NCT00764478|141501681|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.32||0.7746|TWO_SIDED|95.0|-0.7|0.5|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.5|-0.7|0.7746
70997047|NCT00764478|141501681|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.32||0.2754|TWO_SIDED|95.0|-1.0|0.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||0.3|-1.0|0.2754
70997048|NCT00764478|141501681|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.34||0.9109|TWO_SIDED|95.0|-0.6|0.7|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.7|-0.6|0.9109
70997049|NCT00764478|141501681|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.34||0.7295|TWO_SIDED|95.0|-0.6|0.8|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||0.8|-0.6|0.7295
70997050|NCT00764478|141501681|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.38||0.98|TWO_SIDED|95.0|-0.7|0.8|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.8|-0.7|0.9800
70997051|NCT00764478|141501681|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.38||0.5122|TWO_SIDED|95.0|-0.5|1.0|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||1.0|-0.5|0.5122
70997052|NCT00764478|141501682|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.29||0.2191|TWO_SIDED|95.0|-0.9|0.2|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.2|-0.9|0.2191
70997053|NCT00764478|141501682|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.29||0.0589|TWO_SIDED|95.0|-1.1|0.0|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||0.0|-1.1|0.0589
70997054|NCT00764478|141501682|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.36||0.3683|TWO_SIDED|95.0|-1.0|0.4|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.4|-1.0|0.3683
70997055|NCT00764478|141501682|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.37||0.0982|TWO_SIDED|95.0|-1.3|0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||0.1|-1.3|0.0982
70997056|NCT00764478|141501682|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.38||0.1969|TWO_SIDED|95.0|-1.3|0.3|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.3|-1.3|0.1969
70997057|NCT00764478|141501682|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.39||0.5615|TWO_SIDED|95.0|-1.0|0.5|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||0.5|-1.0|0.5615
71040984|NCT01049581|141590470|NON_INFERIORITY_OR_EQUIVALENCE|ANCOVA was used and the result reveled (F1, 17 = 7.565, η2= 0.308, p = 0.007)||||||0.007|ONE_SIDED|95.0|||||ANCOVA|||null hypothesis : there is no difference in gross motor performance in pediatric aquatic therapy group and conventional therapy group||||0.007
71040985|NCT01049581|141590471|NON_INFERIORITY_OR_EQUIVALENCE|ANCOVA : p value 0.393|Mean Difference (Net)|1.762||||0.393|ONE_SIDED|95.0||||"Effect Size η2~0.023"|ANCOVA|F1,17= 0.380||We hypothesize that Children with CP receiving PAT would have better outcomes in motor function and translate to ADL||||0.393
70997058|NCT00764478|141501683|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.33||0.0101|TWO_SIDED|95.0|-1.5|-0.2|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-0.2|-1.5|0.0101
70997059|NCT00764478|141501683|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.34||0.0146|TWO_SIDED|95.0|-1.5|-0.2|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||-0.2|-1.5|0.0146
70997060|NCT00764478|141501683|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.39||0.0861|TWO_SIDED|95.0|-1.4|0.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.1|-1.4|0.0861
70997061|NCT00764478|141501683|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.39||0.0342|TWO_SIDED|95.0|-1.6|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.1|-1.6|0.0342
70997062|NCT00764478|141501683|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|0.4||0.0037|TWO_SIDED|95.0|-2.0|-0.4|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||-0.4|-2.0|0.0037
70997063|NCT00764478|141501683|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.41||0.0096|TWO_SIDED|95.0|-1.9|-0.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||-0.3|-1.9|0.0096
70997064|NCT00764478|141501684|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-1.0|STANDARD_ERROR_OF_MEAN|0.32||0.0019|TWO_SIDED|95.0|-1.7|-0.4|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-0.4|-1.7|0.0019
70997065|NCT00764478|141501684|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.33||0.0791|TWO_SIDED|95.0|-1.2|0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||0.1|-1.2|0.0791
71100220|NCT02662582|141709109|SUPERIORITY||LSMean difference|0.052||||0.447|TWO_SIDED|90.0|-0.063|0.167||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.167|-0.063|0.447
70997066|NCT00764478|141501684|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|0.36||0.0006|TWO_SIDED|95.0|-2.0|-0.5|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||-0.5|-2.0|0.0006
70997067|NCT00764478|141501684|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.37||0.0123|TWO_SIDED|95.0|-1.6|-0.2|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.2|-1.6|0.0123
70997068|NCT00764478|141501684|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.41||0.0054|TWO_SIDED|95.0|-2.0|-0.3|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||-0.3|-2.0|0.0054
71040986|NCT01049581|141590472|SUPERIORITY_OR_OTHER|||||||0.332|ONE_SIDED|95.0|||||ANCOVA|||null hypothesis : there is no difference in social participation between pediatric aquatic therapy group and conventional therapy group||||0.332
71100221|NCT02662582|141709110|SUPERIORITY||LSMean difference|-0.8||||0.099|TWO_SIDED|90.0|-1.7|0.0||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Borg (Dyspnea) at Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0|-1.7|0.099
70997069|NCT00764478|141501684|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.41||0.035|TWO_SIDED|95.0|-1.7|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||-0.1|-1.7|0.0350
70997070|NCT02555657|141501698|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0574|TWO_SIDED|95.0|0.57|1.06|||Regression, Cox|||||1.06|0.57|0.0574
70997071|NCT02555657|141501699|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0728|TWO_SIDED|95.0|0.69|1.06|||Regression, Cox|||||1.06|0.69|0.0728
70997072|NCT02555657|141501700|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.3802|TWO_SIDED|95.0|0.82|1.15|||Regression, Cox|||||1.15|0.82|0.3802
70997073|NCT02555657|141501701|SUPERIORITY||Difference in percentages|8.3||||0.0457|TWO_SIDED|95.0|-1.4|18.4|||Miettinen & Nurminen method|||||18.4|-1.4|0.0457
70997074|NCT02555657|141501702|SUPERIORITY||Difference in percentages|2.9||||0.1752|TWO_SIDED|95.0|-3.3|9.2|||Miettinen & Nurminen method|||||9.2|-3.3|0.1752
70997075|NCT02555657|141501703|SUPERIORITY||Difference in percentages|-1.0||||0.6629|TWO_SIDED|95.0|-5.9|3.8|||Miettinen & Nurminen method|||||3.8|-5.9|0.6629
70997076|NCT02555657|141501704|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.7936|TWO_SIDED|95.0|0.82|1.59|||Regression, Cox|||||1.59|0.82|0.7936
70997077|NCT02555657|141501705|SUPERIORITY||Hazard Ratio (HR)|1.35||||0.9964|TWO_SIDED|95.0|1.08|1.68|||Regression, Cox|||||1.68|1.08|0.9964
70997078|NCT02555657|141501706|SUPERIORITY||Hazard Ratio (HR)|1.6||||1|TWO_SIDED|95.0|1.33|1.92|||Regression, Cox|||||1.92|1.33|1.0000
70997079|NCT02555657|141501710|SUPERIORITY||Difference in percentages|2.3||||0.3388|TWO_SIDED|95.0|-8.7|13.5|||Miettinen & Nurminen method|||||13.5|-8.7|0.3388
70997080|NCT02555657|141501711|SUPERIORITY||Difference in percentages|-1.6||||0.6701|TWO_SIDED|95.0|-8.6|5.5|||Miettinen & Nurminen method|||||5.5|-8.6|0.6701
70997081|NCT02555657|141501712|SUPERIORITY||Difference in percentages|-6.5||||0.9877|TWO_SIDED|95.0|-12.2|-0.8|||Miettinen & Nurminen method|||||-0.8|-12.2|0.9877
70997082|NCT00676793|141501725|SUPERIORITY_OR_OTHER||||||=|0.078||95.0|||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no change, i.e. median change=0.0.||||=0.078
70997083|NCT00676793|141501726|SUPERIORITY_OR_OTHER||||||=|0.094||95.0|||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no change, i.e. median change=0.0.||||=0.094
70997084|NCT02259127|141501739|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.08|||=|0.004|TWO_SIDED|95.0|-0.14|-0.03|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (primary endpoint) was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Primary: Diff in adj. KM estimates (\>=14kg)~Number of subjects included in analysis: 707~Analysis specification: Pre-specified"||-0.03|-0.14|= 0.004
70997085|NCT02259127|141501739|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.18|||=|0.057|TWO_SIDED|95.0|-0.36|0.02|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (primary endpoint) was estimated using Kaplan-Meier curves adjusted for trial cohort (ODYSSEY A or ODYSSEY B)|"Statistical Analysis Title: Diff in adj. KM estimates (Frequentist \<14kg)~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||0.02|-0.36|=0.057
70997086|NCT02259127|141501739|NON_INFERIORITY|Bayesian estimation was used for the primary analysis of the difference in treatment failure by 96 weeks by arm in \<14kg cohort. An informative prior distribution was used based on the treatment effect observed in \>=14kg cohort, with relative weight defined by clinical opinion, solicited prior to the main trial results.|Risk Difference (RD)|-0.1||||0.02|TWO_SIDED|95.0|-0.19|-0.02|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (primary endpoint) was estimated using Kaplan-Meier curves adjusted for trial cohort (ODYSSEY A or ODYSSEY B)|"Statistical Analysis Title: Primary: diff in adj. KM estimates (Bayesian \<14kg)~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||-0.02|-0.19|0.02
70997087|NCT02259127|141501739|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.12||||0.003|TWO_SIDED|95.0|-0.21|-0.04|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (primary endpoint) was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (ODYSSEY A\>=14kg)~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||-0.04|-0.21|0.003
70997088|NCT02259127|141501739|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.05||||0.22|TWO_SIDED|95.0|-0.12|0.03|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (primary endpoint) was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||0.03|-0.12|0.22
70997089|NCT02259127|141501740|SUPERIORITY||Risk Difference (RD)|5.0|||=|0.1377|TWO_SIDED|95.0|-1.0|11.0|||Regression, Logistic|||"Statistical Analysis Title: Adjusted Difference (\>=14kg)~Number of subjects included in analysis: 665~Analysis Specification: Pre-specified"||11|-1|= 0.1377
70997090|NCT02259127|141501740|SUPERIORITY||Risk Difference (RD)|-1.0|||=|0.8895|TWO_SIDED|95.0|-10.0|8.0|||Regression, Logistic|||"Statistical Analysis Title: Adjusted difference (ODYSSEY A \>=14kg)~Number of subjects included in analysis: 286~Analysis Specification: Pre-specified"||8|-10|= 0.8895
70997091|NCT02259127|141501740|SUPERIORITY||Risk Difference (RD)|9.0|||=|0.0435|TWO_SIDED|95.0|0.4|17.0|||Regression, Logistic|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 381~Analysis Specification: Pre-specified"||17|0.4|=0.0435
70997092|NCT02259127|141501740|SUPERIORITY||Risk Difference (RD)|26.0||||0.021|TWO_SIDED|95.0|6.0|47.0|||Regression, Logistic|||||47|6|0.021
70997093|NCT02259127|141501741|SUPERIORITY||Risk Difference (RD)|3.0|||=|0.2256|TWO_SIDED|95.0|-2.0|8.0|||Regression, Logistic|||"Statistical Analysis Title: Adjusted Difference (\>=14kg)~Number of subjects included in analysis: 670~Analysis Specification: Pre-specified"||8|-2|= 0.2256
70997094|NCT02259127|141501741|SUPERIORITY||Risk Difference (RD)|0.0|||=|0.9536|TWO_SIDED|95.0|-8.0|7.0|||Regression, Logistic|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY A \>=14kg)~Number of subjects included in analysis: 286~Analysis Specification: Pre-specified"||7|-8|= 0.9536
70997095|NCT02259127|141501741|SUPERIORITY||Risk Difference (RD)|6.0|||=|0.1104|TWO_SIDED|95.0|-1.0|12.0|||Regression, Logistic|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 384~Analysis Specification: Pre-specified"||12|-1|= 0.1104
70997096|NCT02259127|141501741|SUPERIORITY||Risk Difference (RD)|19.0||||0.038|TWO_SIDED|95.0|2.0|37.0|||Regression, Logistic|||||37|2|0.038
70997097|NCT02259127|141501742|SUPERIORITY||Mean Difference (Final Values)|35.0|||=|0.144|TWO_SIDED|95.0|-12.0|82.0|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (\>=14kg)~Statistical analysis description: Linear regression of CD4 at week 96, adjusted for randomised arm, baseline CD4 and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||82|-12|= 0.144
71040987|NCT02367872|141590473|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|51.08|||||TWO_SIDED|95.0|35.22|74.08||||||TAK-272F: Least square mean (LS) mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95 percent (%) confidence intervals (CI) were calculated using an analysis of variance (ANOVA) model for natural log-transformed data.||74.08|35.22|
71040988|NCT02367872|141590473|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|117.95|||||TWO_SIDED|95.0|81.32|171.07||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||171.07|81.32|
70997098|NCT02259127|141501742|SUPERIORITY||Mean Difference (Final Values)|44.0||||0.185|TWO_SIDED|95.0|-21.0|109.0|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY A \>=14kg)~Statistical analysis description: Linear regression of CD4 at week 96, adjusting for randomised arm, baseline CD4 and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||109|-21|0.185
71040989|NCT02367872|141590473|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|272.87|||||TWO_SIDED|95.0|188.14|395.76||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||395.76|188.14|
71040990|NCT02367872|141590473|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|183.27|||||TWO_SIDED|95.0|126.36|265.81||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||265.81|126.36|
70997099|NCT02259127|141501742|SUPERIORITY||Mean Difference (Final Values)|27.0|||=|0.427|TWO_SIDED|95.0|-39.0|93.0|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY B \>=14kg)~Statistical analysis description: Linear regression of CD4 at week 96, adjusting for randomised arm, baseline CD4 and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||93|-39|= 0.427
70997100|NCT02259127|141501742|SUPERIORITY||Median Difference (Final Values)|30.0||||0.86|TWO_SIDED|95.0|-308.0|368.0|||Regression, Linear|||||368|-308|0.86
70997101|NCT02259127|141501743|SUPERIORITY||Mean Difference (Final Values)|-15.1|||<|0.001|TWO_SIDED|95.0|-19.0|-11.1|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (\>=14kg)~Statistical analysis description: Linear regression of total cholesterol at week 96, adjusting for randomised arm, baseline total cholesterol and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||-11.1|-19|< 0.001
70997102|NCT02259127|141501743|SUPERIORITY||Mean Difference (Final Values)|-24.4|||=|0.0032|TWO_SIDED|95.0|-40.3|-8.5|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (\<14kg)~Statistical analysis description: Linear regression of total cholesterol at week 96, adjusting for randomised arm, baseline total cholesterol and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||-8.5|-40.3|= 0.0032
70997103|NCT02259127|141501743|SUPERIORITY||Mean Difference (Final Values)|-17.5|||<|0.001|TWO_SIDED|95.0|-23.9|-11.1|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY A \>=14kg)~Statistical analysis description: Linear regression of total cholesterol at week 96, adjusting for randomised arm, baseline total cholesterol and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||-11.1|-23.9|< 0.001
70997104|NCT02259127|141501743|SUPERIORITY||Mean Difference (Final Values)|-13.4|||<|0.001|TWO_SIDED|95.0|-18.5|-8.4|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY B \>=14kg)~Statistical analysis description: Linear regression of total cholesterol at week 96, adjusting for randomised arm, baseline total cholesterol and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||-8.4|-18.5|< 0.001
70997105|NCT02259127|141501744|SUPERIORITY||Hazard Ratio (HR)|0.87|||=|0.53|TWO_SIDED|95.0|0.55|1.36|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\>=14kg)~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||1.36|0.55|= 0.53
70997106|NCT02259127|141501744|SUPERIORITY||Hazard Ratio (HR)|1.08|||=|0.86|TWO_SIDED|95.0|0.47|2.49|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\<14kg)~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||2.49|0.47|= 0.86
70997107|NCT02259127|141501744|SUPERIORITY||Hazard Ratio (HR)|0.83|||=|0.52|TWO_SIDED|95.0|0.48|1.46|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY A \>=14kg)~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||1.46|0.48|= 0.52
70997108|NCT02259127|141501744|SUPERIORITY||Hazard Ratio (HR)|0.93|||=|0.86|TWO_SIDED|95.0|0.42|2.04|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||2.04|0.42|= 0.86
70997109|NCT02259127|141501745|SUPERIORITY||Hazard Ratio (HR)|0.83|||=|0.24|TWO_SIDED|95.0|0.61|1.13|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\>=14kg)~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||1.13|0.61|= 0.24
70997110|NCT02259127|141501745|SUPERIORITY||Hazard Ratio (HR)|0.93|||=|0.83|TWO_SIDED|95.0|0.5|1.74|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\<14kg)~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||1.74|0.5|= 0.83
70997111|NCT02259127|141501745|SUPERIORITY||Hazard Ratio (HR)|1.13|||=|0.57|TWO_SIDED|95.0|0.75|1.7|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY A \>=14kg)~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||1.7|0.75|= 0.57
71040991|NCT02367872|141590473|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|101.67|||||TWO_SIDED|95.0|68.95|149.9||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||149.90|68.95|
71040992|NCT02367872|141590473|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|135.98|||||TWO_SIDED|95.0|92.23|200.5||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||200.50|92.23|
70997112|NCT02259127|141501745|SUPERIORITY||Hazard Ratio (HR)|0.54|||=|0.01|TWO_SIDED|95.0|0.33|0.88|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||0.88|0.33|= 0.01
70997113|NCT02259127|141501746|SUPERIORITY||Hazard Ratio (HR)|0.29|||=|0.01|TWO_SIDED|95.0|0.11|0.77|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\>=14kg)~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||0.77|0.11|= 0.01
70997114|NCT02259127|141501746|SUPERIORITY||Hazard Ratio (HR)|0.35|||=|0.13|TWO_SIDED|95.0|0.09|1.33|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY A \>=14kg)~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||1.33|0.09|= 0.13
70997115|NCT02259127|141501746|SUPERIORITY||Hazard Ratio (HR)|0.22||||0.055|TWO_SIDED|95.0|0.05|1.03|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||1.03|0.05|0.055
70997116|NCT02259127|141501747|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.06|||=|0.003|TWO_SIDED|95.0|-0.1|-0.02|||Bootstrap method||The probability of having virological or clinical treatment failure by 48 weeks was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (\>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 48 weeks after randomisation.~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||-0.02|-0.1|= 0.003
70997117|NCT02259127|141501747|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.07|||=|0.035|TWO_SIDED|95.0|-0.13|-0.01|||Bootstrap method||The probability of having virological or clinical treatment failure by 48 weeks was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (ODYSSEY A \>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 48 weeks after randomisation.~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||-0.01|-0.13|= 0.035
70997118|NCT02259127|141501747|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.05|||=|0.039|TWO_SIDED|95.0|-0.11|-0.004|||Bootstrap method||The probability of having virological or clinical treatment failure by 48 weeks was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (ODYSSEY B \>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 48 weeks after randomisation.~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||-0.004|-0.11|= 0.039
70997119|NCT02259127|141501747|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.18||||0.057|TWO_SIDED|95.0|-0.36|0.02|||Other [Bootstrap method]|||||0.02|-0.36|0.057
70997120|NCT02259127|141501748|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.09|||=|0.003|TWO_SIDED|95.0|-0.16|-0.04|||Bootstrap method||The probability of having virological or clinical treatment failure by 144 weeks was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (\>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 144 weeks after randomisation.~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||-0.04|-0.16|= 0.003
71008545|NCT02055976|141525223|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-66.754|STANDARD_ERROR_OF_MEAN|3.912|<|0.001|TWO_SIDED|95.0|-74.523|-58.986|||Mixed Models Analysis|One-sided p-value (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-58.986|-74.523|<0.001
71008546|NCT02055976|141525223|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-71.534|STANDARD_ERROR_OF_MEAN|3.903|<|0.001|TWO_SIDED|95.0|-79.284|-63.784|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-63.784|-79.284|<0.001
71008547|NCT02055976|141525223|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-47.531|STANDARD_ERROR_OF_MEAN|4.016|<|0.001|TWO_SIDED|95.0|-55.511|-39.551|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-39.551|-55.511|<0.001
71008548|NCT02055976|141525223|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-62.624|STANDARD_ERROR_OF_MEAN|3.993|<|0.001|TWO_SIDED|95.0|-70.557|-54.691|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-54.691|-70.557|<0.001
71008549|NCT02055976|141525223|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-64.268|STANDARD_ERROR_OF_MEAN|3.955|<|0.001|TWO_SIDED|95.0|-72.128|-56.409|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-56.409|-72.128|<0.001
70997121|NCT02259127|141501748|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.12|||=|0.009|TWO_SIDED|95.0|-0.21|-0.03|||Bootstrap method||The probability of having virological or clinical treatment failure by 144 weeks was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (ODYSSEY A \>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 144 weeks after randomisation.~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||-0.03|-0.21|= 0.009
70997122|NCT02259127|141501748|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.08|||=|0.079|TWO_SIDED|95.0|-0.16|0.01|||Bootstrap method||The probability of having virological or clinical treatment failure by 144 weeks was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (ODYSSEY B \>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 144 weeks after randomisation.~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||0.01|-0.16|= 0.079
70997123|NCT02259127|141501749|SUPERIORITY||Hazard Ratio (HR)|1.0|||=|0.993|TWO_SIDED|95.0|0.38|2.68|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\>=14kg)~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||2.68|0.38|= 0.993
70997124|NCT02259127|141501749|SUPERIORITY||Hazard Ratio (HR)|0.5|||=|0.33|TWO_SIDED|95.0|0.13|2.0|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\<14kg)~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||2|0.13|= 0.33
70997125|NCT02259127|141501749|SUPERIORITY||Hazard Ratio (HR)|1.01|||=|0.991|TWO_SIDED|95.0|0.32|3.12|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY A \>=14kg)~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||3.12|0.32|= 0.991
70997126|NCT02259127|141501749|SUPERIORITY||Hazard Ratio (HR)|1.0|||=|0.997|TWO_SIDED|95.0|0.14|7.13|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||7.13|0.14|= 0.997
70997127|NCT02259127|141501750|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.07|||=|0.015|TWO_SIDED|95.0|-0.12|-0.01|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (per protocol analysis) was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (\>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 96 weeks after randomisation.~Number of subjects included in analysis: 677~Analysis Specification: Pre-specified"||-0.01|-0.12|= 0.015
70997128|NCT02259127|141501750|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.172|||=|0.075|TWO_SIDED|95.0|-0.362|0.029|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (per protocol analysis) was estimated using Kaplan-Meier curves adjusted for trial cohort (ODYSSEY A or ODYSSEY B)|"Statistical Analysis Title: Adjusted difference (frequentist \<14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 96 weeks after randomisation.~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||0.029|-0.362|= 0.075
70997129|NCT02259127|141501750|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.126|||=|0.004|TWO_SIDED|95.0|-0.21|-0.036|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (per protocol analysis) was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Adjusted Difference (ODYSSEY A \>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 96 weeks after randomisation.~Number of subjects included in analysis: 295~Analysis Specification: Pre-specified"||-0.036|-0.21|= 0.004
70997130|NCT02259127|141501750|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.023|||=|0.547|TWO_SIDED|95.0|-0.096|0.056|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (per protocol analysis) was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Adjusted Difference (ODYSSEY B \>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 96 weeks after randomisation.~Number of subjects included in analysis: 382~Analysis Specification: Pre-specified"||0.056|-0.096|= 0.547
70997131|NCT02259127|141501765|SUPERIORITY||Mean Difference (Final Values)|1.0|||=|0.004|TWO_SIDED|95.0|0.3|1.7|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (\>=14kg)~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||1.7|0.3|= 0.004
70997132|NCT02259127|141501765|SUPERIORITY||Mean Difference (Final Values)|1.4|||=|0.024|TWO_SIDED|95.0|0.2|2.5|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY A \>=14kg)~Statistical analysis description: Linear regression of weight at week 96, adjusting for randomised arm, baseline weight and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||2.5|0.2|= 0.024
70997133|NCT02259127|141501765|SUPERIORITY||Mean Difference (Final Values)|0.8|||=|0.075|TWO_SIDED|95.0|-0.1|1.6|||Regression, Linear|||"Statistical Analysis Title: Adjusting Difference (ODYSSEY B \>=14kg)~Statistical analysis description: Linear regression of weight at week 96, adjusting for randomised arm, baseline weight and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||1.6|-0.1|= 0.075
70997134|NCT02259127|141501765|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.67|TWO_SIDED|95.0|-0.8|0.5|||Regression, Linear|||||0.5|-0.8|0.67
70997135|NCT02259127|141501766|SUPERIORITY||Mean Difference (Final Values)|0.13|||=|0.036|TWO_SIDED|95.0|0.01|0.25|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (\>=14kg)~Statistical analysis description: Linear regression of BMI-for-age at week 96, adjusting for randomised arm, baseline BMI-for-age and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||0.25|0.01|= 0.036
70997136|NCT02259127|141501766|SUPERIORITY||Mean Difference (Final Values)|0.17|||=|0.092|TWO_SIDED|95.0|-0.03|0.36|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY A \>=14kg)~Statistical analysis description: Linear regression of BMI-for-age at week 96, adjusting for randomised arm, baseline BMI-for-age and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||0.36|-0.03|=0.092
70997137|NCT02259127|141501766|SUPERIORITY||Mean Difference (Final Values)|0.1|||=|0.176|TWO_SIDED|95.0|-0.05|0.25|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY B \>=14kg)~Statistical analysis description: Linear regression of BMI-for-age at week 96, adjusting for randomised arm, baseline BMI-for-age and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||0.25|-0.05|=0.176
70997138|NCT02259127|141501766|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.5|TWO_SIDED|95.0|-1.1|0.5|||Regression, Linear|||||0.5|-1.1|0.50
71100222|NCT02662582|141709110|SUPERIORITY||LSMean difference|-0.5||||0.255|TWO_SIDED|90.0|-1.3|0.2||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Borg (Dyspnea) at isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.2|-1.3|0.255
70997139|NCT03788967|141501769|NON_INFERIORITY|The non-inferiority hypothesis test was a 1-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the 95% CI for the difference in overall response was greater than -12.5%, non-inferiority was declared.|Risk Difference|-3.3|||||TWO_SIDED|95.0|-9.7|3.2||||||||3.2|-9.7|
70997140|NCT03788967|141501771|OTHER||Risk Difference|-4.7|||||TWO_SIDED|95.0|-11.3|1.9||||||||1.9|-11.3|
70997141|NCT03788967|141501772|OTHER||Risk Difference|1.4|||||TWO_SIDED|95.0|-0.1|3.4||||||Statistical Analysis 1 (EOT)||3.4|-0.1|
70997142|NCT03788967|141501772|OTHER||Risk Difference|-0.6|||||TWO_SIDED|95.0|-4.0|2.8||||||Statistical Analysis 2 (TOC)||2.8|-4|
70997143|NCT03788967|141501772|OTHER||Risk Difference|-1.5|||||TWO_SIDED|95.0|-5.7|2.6||||||Statistical Analysis 3 (LFU)||2.6|-5.7|
70997144|NCT03788967|141501773|OTHER||Risk Difference|0.7|||||TWO_SIDED|95.0|-0.3|2.0||||||||2.0|-0.3|
70997145|NCT03788967|141501774|OTHER||Risk Difference|-1.6|||||TWO_SIDED|95.0|-3.8|0.6||||||||0.6|-3.8|
70997146|NCT03788967|141501775|OTHER||Risk Difference|-0.5|||||TWO_SIDED|95.0|-3.3|2.3||||||||2.3|-3.3|
70997147|NCT03788967|141501776|OTHER||Risk Difference|1.3|||||TWO_SIDED|95.0|-0.2|3.2||||||||3.2|-0.2|
70997148|NCT03788967|141501777|OTHER||Risk Difference|-2.2|||||TWO_SIDED|95.0|-5.3|0.8||||||||0.8|-5.3|
70997149|NCT03788967|141501778|OTHER||Risk Difference|-1.2|||||TWO_SIDED|95.0|-5.1|2.6||||||||2.6|-5.1|
70997150|NCT03788967|141501779|OTHER||Risk Difference|1.5|||||TWO_SIDED|95.0|-0.8|4.1||||||Statistical Analysis 1 (EOT)||4.1|-0.8|
70997151|NCT03788967|141501779|OTHER||Risk Difference|-4.5|||||TWO_SIDED|95.0|-10.8|1.9||||||Statistical Analysis 2 (TOC)||1.9|-10.8|
70997152|NCT03788967|141501779|OTHER||Risk Difference|-1.5|||||TWO_SIDED|95.0|-7.9|5.0||||||||5|-7.9|
70997153|NCT03788967|141501783|OTHER||Risk Difference|-0.2|||||TWO_SIDED|95.0|-1.6|1.2||||||||1.2|-1.6|
70997154|NCT03788967|141501784|OTHER||Risk Difference|-5.9|||||TWO_SIDED|95.0|-12.4|0.7||||||||0.7|-12.4|
70997155|NCT03788967|141501785|OTHER||Risk Difference (RD)|-1.6|||||TWO_SIDED|95.0|-8.5|5.3||||||||5.3|-8.5|
70997156|NCT03788967|141501789|OTHER||Risk Difference|-4.7|||||TWO_SIDED|95.0|-13.5|4.1||||||Overall response for participants with AP||4.1|-13.5|
70997157|NCT03788967|141501789|OTHER||Risk Difference|-1.6|||||TWO_SIDED|95.0|-11.0|7.7||||||Overall response in participants with cUTI||7.7|-11.0|
70997158|NCT03788967|141501790|OTHER||Risk Difference|1.4|||||TWO_SIDED|95.0|-7.2|9.9||||||||9.9|-7.2|
70997159|NCT03788967|141501790|OTHER||Risk Difference (RD)|-8.4|||||TWO_SIDED|95.0|-20.6|3.8||||||≥65 to \<75 years||3.8|-20.6|
70997160|NCT03788967|141501790|OTHER||Risk Difference (RD)|-7.5|||||TWO_SIDED|95.0|-23.8|8.7||||||≥75 years||8.7|-23.8|
70997161|NCT03788967|141501791|OTHER||Risk Difference|-3.1|||||TWO_SIDED|95.0|-9.6|3.5||||||Central and Eastern Europe||3.5|-9.6|
70997162|NCT03788967|141501792|OTHER|||||||0.044|||||||Log Rank|||||||0.044
70997163|NCT03788967|141501793|OTHER|||||||0.736|||||||Log Rank|||||||0.736
70997164|NCT04058158|141501807|EQUIVALENCE|Pre-defined equivalence margin was \[-337.2 to 337.2\].|Least squares mean difference|34.48|||||TWO_SIDED|95.0|-47.66|116.62||||||||116.62|-47.66|
70997165|NCT04058158|141501808|EQUIVALENCE|Pre-defined equivalence margin was \[0.77 to 1.29\].|Ratio of geometric least squares mean|1.08|||||TWO_SIDED|90.0|0.95|1.23||||||||1.23|0.95|
70997166|NCT04847141|141501809|SUPERIORITY||Difference in Percentage|-3.6||||0.5167|TWO_SIDED|95.0|-14.6|7.4||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants meeting the primary efficacy endpoint between C19-IG 20% 1 g and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|||7.4|-14.6|0.5167
70997167|NCT04847141|141501809|SUPERIORITY||Difference in Percentage|1.2||||0.8197|TWO_SIDED|95.0|-9.6|12.0||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants meeting the primary efficacy endpoint between C19-IG 20% 2 g and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|||12.0|-9.6|0.8197
70997168|NCT04847141|141501810|SUPERIORITY||Least squares (LS) Mean Difference|0.1||||0.5756|TWO_SIDED|95.0|-0.24|0.44|||ANCOVA||95% CI for the difference in LS Mean between 1 g C19-IG 20% dose group \& placebo was calculated using ANCOVA model, including CFB value as dependent variable; treatment group as fixed effect; \& baseline viral load value, age, \& gender as covariates.|Day 7||0.44|-0.24|0.5756
70997169|NCT04847141|141501810|SUPERIORITY||LS Mean Difference|-0.17||||0.3289|TWO_SIDED|95.0|-0.52|0.17|||ANCOVA||95% CI for the difference in LS Mean between 2 g C19-IG 20% dose group \& placebo was calculated using ANCOVA model, including CFB value as dependent variable; treatment group as fixed effect; \& baseline viral load value, age, \& gender as covariates.|Day 7||0.17|-0.52|0.3289
70997170|NCT04847141|141501810|SUPERIORITY||LS Mean Difference|0.11||||0.3418|TWO_SIDED|95.0|-0.12|0.34|||ANCOVA||95% CI for the difference in LS Mean between 1 g C19-IG 20% dose group \& placebo was calculated using ANCOVA model, including CFB value as dependent variable; treatment group as fixed effect; \& baseline viral load value, age, \& gender as covariates.|Day 14||0.34|-0.12|0.3418
70997171|NCT04847141|141501810|SUPERIORITY||LS Mean Difference|-0.11||||0.3688|TWO_SIDED|95.0|-0.34|0.13|||ANCOVA||95% CI for the difference in LS Mean between 2 g C19-IG 20% dose group \& placebo was calculated using ANCOVA model, including CFB value as dependent variable; treatment group as fixed effect; \& baseline viral load value, age, \& gender as covariates.|Day 14||0.13|-0.34|0.3688
70997172|NCT04847141|141501811|SUPERIORITY||Difference in Percentage|-1.3||||0.1506|TWO_SIDED|95.0|-4.7|1.2||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who remained in an outpatient setting \& maintained SpO2≥94% between C19-IG 20% 2 g \& placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 3||1.2|-4.7|0.1506
70997173|NCT04847141|141501811|SUPERIORITY||Difference in Percentage|1.3||||0.1655|TWO_SIDED|95.0|-1.3|4.6||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who remained in an outpatient setting \& maintained SpO2≥94% between C19-IG 20% 1 g \& placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|Day 7||4.6|-1.3|0.1655
70997174|NCT04847141|141501811|SUPERIORITY||Difference in Percentage|-2.0||||0.2337|TWO_SIDED|95.0|-6.5|1.7||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who remained in an outpatient setting \& maintained SpO2≥94% between C19-IG 20% 2 g \& placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 7||1.7|-6.5|0.2337
70997175|NCT04847141|141501811|SUPERIORITY||Difference in Percentage|-0.8||||0.7212|TWO_SIDED|95.0|-6.1|4.2||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who remained in an outpatient setting \& maintained SpO2≥94% between C19-IG 20% 1 g \& placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|Day 14||4.2|-6.1|0.7212
70997176|NCT04847141|141501811|SUPERIORITY||Difference in Percentage|-2.1||||0.3897|TWO_SIDED|95.0|-7.8|3.1||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who remained in an outpatient setting \& maintained SpO2≥94% between C19-IG 20% 2 g \& placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 14||3.1|-7.8|0.3897
70997177|NCT04847141|141501812|SUPERIORITY||Difference in Percentage|3.1||||0.5489|TWO_SIDED|95.0|-7.1|13.3||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|Day 3||13.3|-7.1|0.5489
70997178|NCT04847141|141501812|SUPERIORITY||Difference in Percentage|4.4||||0.392|TWO_SIDED|95.0|-5.8|14.7||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 3||14.7|-5.8|0.3920
70997179|NCT04847141|141501812|SUPERIORITY||Difference in Percentage|1.7||||0.7632|TWO_SIDED|95.0|-9.5|12.9||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|Day 7||12.9|-9.5|0.7632
70997180|NCT04847141|141501812|SUPERIORITY||Difference in Percentage|7.9||||0.1702|TWO_SIDED|95.0|-3.6|19.2||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 7||19.2|-3.6|0.1702
71040993|NCT02367872|141590473|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|62.34|||||TWO_SIDED|95.0|36.17|107.45||||||M-I: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||107.45|36.17|
71040994|NCT02367872|141590473|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|93.2|||||TWO_SIDED|95.0|54.08|160.64||||||M-I: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||160.64|54.08|
71100223|NCT02662582|141709110|SUPERIORITY||LSMean difference|-0.2||||0.651|TWO_SIDED|90.0|-1.1|0.6||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Borg (Leg Effort) at Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.6|-1.1|0.651
71100224|NCT02662582|141709110|SUPERIORITY||LSMean difference|-0.3||||0.591|TWO_SIDED|90.0|-1.0|0.5||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Borg (Leg Effort) at isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.5|-1.0|0.591
71100225|NCT02662582|141709111|SUPERIORITY||LSMean difference|0.0286||||0.04|TWO_SIDED|90.0|0.0061|0.0511||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0511|0.0061|0.040
70997181|NCT04847141|141501812|SUPERIORITY||Difference in Percentage|-2.0||||0.7316|TWO_SIDED|95.0|-13.3|9.4||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|Day 14||9.4|-13.3|0.7316
71040995|NCT02367872|141590473|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|274.21|||||TWO_SIDED|95.0|159.1|472.63||||||M-I: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||472.63|159.10|
71100226|NCT02662582|141709111|SUPERIORITY||LSMean differencce|0.0185||||0.155|TWO_SIDED|90.0|-0.0031|0.0401||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0401|-0.0031|0.155
71100227|NCT02662582|141709112|SUPERIORITY||LSMean difference|0.001||||0.972|TWO_SIDED|90.0|-0.0459|0.0479||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0479|-0.0459|0.972
71100228|NCT02662582|141709112|SUPERIORITY||LSMean difference|-0.0118||||0.578|TWO_SIDED|90.0|-0.0471|0.0236||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0236|-0.0471|0.578
70923764|NCT04521478|141339292|OTHER||Mean Difference (Net)|3.4|STANDARD_ERROR_OF_MEAN|2.5||0.1723|TWO_SIDED|90.0|-0.7|7.6|||Mixed Models Analysis||Difference = (adjusted mean 5 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||7.6|-0.7|0.1723
70923765|NCT04521478|141339292|OTHER||Mean Difference (Net)|4.4|STANDARD_ERROR_OF_MEAN|2.5||0.0757|TWO_SIDED|90.0|0.3|8.5|||Mixed Models Analysis||Difference = (adjusted mean 25 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||8.5|0.3|0.0757
70923766|NCT04521478|141339292|OTHER||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|2.4||0.6864|TWO_SIDED|90.0|-3.0|5.0|||Mixed Models Analysis||Difference = (adjusted mean 75 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||5.0|-3.0|0.6864
70923767|NCT04521478|141339292|OTHER||Mean Difference (Net)|2.8|STANDARD_ERROR_OF_MEAN|1.9||0.1585|TWO_SIDED|90.0|-0.5|6.0|||Mixed Models Analysis||Difference = (adjusted mean 125 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||6.0|-0.5|0.1585
70923768|NCT04173663|141339341|SUPERIORITY||Slope|-3.27||||0.092|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the parental empowerment scale.||||||.092
70923769|NCT04173663|141339342|SUPERIORITY||Slope|-1.62||||1.54e-05|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||||||.0000154
70923770|NCT04173663|141339343|SUPERIORITY||Slope|-0.19||||0.014|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||||||.014
70923771|NCT04173663|141339344|SUPERIORITY||Slope|-0.13||||0.883|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||||||0.883
70923772|NCT04173663|141339345|SUPERIORITY||Slope|-0.11||||0.308|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of services family applied for (6 month post intervention)||||.308
70923773|NCT04173663|141339345|SUPERIORITY||Slope|-0.11||||0.355|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of services family applied for (12 month post intervention)||||.355
70923774|NCT04173663|141339346|SUPERIORITY||Slope|-0.06||||0.699|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of government services family is receiving (6 month post intervention)||||.699
70923775|NCT04173663|141339346|SUPERIORITY||Slope|-0.1||||0.573|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of government services the family is receiving (12 month post intervention)||||.573
70923776|NCT04173663|141339346|SUPERIORITY||Slope|-0.23||||0.43|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of direct services the family is receiving (6 month post intervention)||||.430
70923777|NCT04173663|141339346|SUPERIORITY||Slope|0.27||||0.391|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of direct services the family is receiving (12 month post intervention)||||.391
70923778|NCT04173663|141339347|SUPERIORITY||Slope|-0.44||||0.51|TWO_SIDED||||||Regression, Logistic|Logistic regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Whether participants were engaged or not engaged in vocational/educational activities (6 month post intervention)||||.510
70923779|NCT04173663|141339347|SUPERIORITY||Slope|0.64||||0.296|TWO_SIDED||||||Regression, Logistic|Logistic regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Whether participants were engaged or not engaged in vocational/educational activities (12 month post intervention)||||.296
70923780|NCT04173663|141339348|SUPERIORITY||Slope|-0.66||||0.361|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||||||.361
70923781|NCT04173663|141339349|SUPERIORITY||Slope|-0.08||||0.81|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of unmet service needs (6 month post intervention)||||.810
70923782|NCT04173663|141339349|SUPERIORITY||Slope|-0.13||||0.678|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of unmet service needs (12 month post intervention)||||.678
70923783|NCT04173663|141339350|SUPERIORITY||Slope|0.03||||0.924|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site and cohort,||||||.924
71040996|NCT02367872|141590473|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|261.12|||||TWO_SIDED|95.0|151.5|450.05||||||M-I: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||450.05|151.50|
71100229|NCT02662582|141709113|SUPERIORITY||LSMean difference|-0.65||||0.235|TWO_SIDED|90.0|-1.55|0.26||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.26|-1.55|0.235
70997182|NCT04847141|141501812|SUPERIORITY||Difference in Percentage|6.9||||0.2104|TWO_SIDED|95.0|-4.2|18.0||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 14||18.0|-4.2|0.2104
70997183|NCT04847141|141501812|SUPERIORITY||Difference in Percentage|4.9||||0.2059|TWO_SIDED|95.0|-2.9|13.2||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|Day 29||13.2|-2.9|0.2059
70997184|NCT04847141|141501812|SUPERIORITY||Difference in Percentage|1.9||||0.6463|TWO_SIDED|95.0|-6.5|10.3||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 29||10.3|-6.5|0.6463
70997185|NCT04847141|141501813|SUPERIORITY|||||||0.9033|||||||Log Rank|||||||0.9033
70997186|NCT04847141|141501813|SUPERIORITY|||||||0.5456|||||||Log Rank|||||||0.5456
70997187|NCT04847141|141501814|SUPERIORITY||Difference in Percentage|0.79||||0.6311|TWO_SIDED|95.0|-2.9|4.6||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required oxygen supplementation between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between each of 1 g C19-IG 20% dose group and placebo was calculated using the exact unconditional method.|||4.6|-2.9|0.6311
70997188|NCT04847141|141501814|SUPERIORITY||Difference in Percentage|2.6||||0.1441|TWO_SIDED|95.0|-1.2|7.3||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required oxygen supplementation between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between each of 2 g C19-IG 20% dose group and placebo was calculated using the exact unconditional method.|||7.3|-1.2|0.1441
70997189|NCT04847141|141501815|SUPERIORITY||LS Mean (LSM) Difference|0.02||||0.8555|TWO_SIDED|95.0|-0.23|0.27|||ANCOVA||95% CI for difference in LSM between 1 g C19-IG 20% \& placebo was calculated using an ANCOVA model,with number of days on oxygen as dependent variable \& treatment group as fixed effect,adjusting for baseline characteristics(including age \& gender).|||0.27|-0.23|0.8555
70997190|NCT04847141|141501815|SUPERIORITY||LS Mean Difference|0.03||||0.8108|TWO_SIDED|95.0|-0.22|0.28|||ANCOVA||95% CI for difference in LSM between 2 g C19-IG 20% \& placebo was calculated using an ANCOVA model,with number of days on oxygen as dependent variable \& treatment group as fixed effect,adjusting for baseline characteristics(including age \& gender).|||0.28|-0.22|0.8108
70997191|NCT04847141|141501817|SUPERIORITY||LS Mean Difference|0.03||||0.0692|TWO_SIDED|95.0|0.0|0.07||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 7||0.07|-0.00|0.0692
70997192|NCT04847141|141501817|SUPERIORITY||LS Mean Difference|0.01||||0.4956|TWO_SIDED|95.0|-0.02|0.05||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 7||0.05|-0.02|0.4956
70997193|NCT04847141|141501817|SUPERIORITY||LS Mean Difference|-0.05||||0.22|TWO_SIDED|95.0|-0.13|0.03||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 14||0.03|-0.13|0.2200
70997194|NCT04847141|141501817|SUPERIORITY||LS Mean Difference|-0.07||||0.0906|TWO_SIDED|95.0|-0.14|0.01||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 14||0.01|-0.14|0.0906
70997195|NCT04847141|141501817|SUPERIORITY||LS Mean Difference|-0.04||||0.0439|TWO_SIDED|95.0|-0.07|0.0||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 29||-0.00|-0.07|0.0439
71100230|NCT02662582|141709113|SUPERIORITY||LSMean differencce|-0.57||||0.215|TWO_SIDED|90.0|-1.33|0.19||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.19|-1.33|0.215
70923784|NCT04850807|141339352|SUPERIORITY||average marginal effect|-0.4|STANDARD_ERROR_OF_MEAN|3.3|<|0.05|TWO_SIDED|95.0|-6.9|6.0|||Differences-in-Differences regression||||"Fixed effect covariates: age, sex, race, activities of daily living score, cognitive function score, psychotic disorder, bipolar disease, depression, anxiety, dementia, alzheimer's diagnosis, antidepressant use, antianxietal use, antipsychotic use, history of heart failure, baseline ARBS (exclusive to CMAI model), baseline CMAI (exclusive to ARBS model), indicator of baseline/follow-up score, treatment group, interaction of treatment group and baseline/follow-up score.~Random effects: random intercept for nursing home, random intercept for the interaction of baseline/follow-up measure and nursing home, and random intercept for individual.~Imputed Outcomes: 37 Control Follow-Up (Both CMAI and ARBS), 37 Treatment Follow-Up (ABRS), 35 Treatment Follow-Up (CMAI)"|6.0|-6.9|<0.05
71040997|NCT02367872|141590473|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|112.47|||||TWO_SIDED|95.0|69.34|182.41||||||M-I: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||182.41|69.34|
71040998|NCT02367872|141590473|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|176.75|||||TWO_SIDED|95.0|108.97|286.67||||||M-I: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||286.67|108.97|
71040999|NCT02367872|141590474|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|57.36|||||TWO_SIDED|95.0|37.76|87.14||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||87.14|37.76|
71041000|NCT02367872|141590474|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|77.04|||||TWO_SIDED|95.0|50.72|117.03||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||117.03|50.72|
71041001|NCT02367872|141590474|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|206.41|||||TWO_SIDED|95.0|135.88|313.54||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||313.54|135.88|
71041002|NCT02367872|141590474|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|143.11|||||TWO_SIDED|95.0|94.21|217.39||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||217.39|94.21|
71041003|NCT02367872|141590474|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|85.31|||||TWO_SIDED|95.0|51.03|142.61||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||142.61|51.03|
71041004|NCT02367872|141590474|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|131.63|||||TWO_SIDED|95.0|78.74|220.04||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||220.04|78.74|
70923785|NCT04850807|141339353|SUPERIORITY||Average Marginal Effect|0.1|STANDARD_ERROR_OF_MEAN|0.08|<|0.05|TWO_SIDED|95.0|-0.06|0.26|||Differences-in-Differences regression||||"Fixed effect covariates: age, sex, race, activities of daily living score, cognitive function score, psychotic disorder, bipolar disease, depression, anxiety, dementia, alzheimer's diagnosis, antidepressant use, antianxietal use, antipsychotic use, history of heart failure, baseline ARBS (exclusive to CMAI model), baseline CMAI (exclusive to ARBS model), indicator of baseline/follow-up score, treatment group, interaction of treatment group and baseline/follow-up score.~Random effects: random intercept for nursing home, random intercept for the interaction of baseline/follow-up measure and nursing home, and random intercept for individual.~Imputed Outcomes: 37 Control Follow-Up (Both CMAI and ARBS), 37 Treatment Follow-Up (ABRS), 35 Treatment Follow-Up (CMAI)"|0.26|-0.06|<0.05
70923786|NCT04850807|141339354|SUPERIORITY||average marginal effect|4.0|STANDARD_ERROR_OF_MEAN|3.2|<|0.05|TWO_SIDED|95.0|-2.3|10.2|||Differences-in-Differences regression||||"Fixed effect covariates: baseline medication use, age, sex, race, activities of daily living score, cognitive function score, psychotic diagnosis, depression, anxiety, dementia, asthma, ARBS score, treatment group.~Random effects: random intercept for nursing home Imputed Outcomes: 37 Control Follow-Up , 35 Treatment Follow-Up"|10.2|-2.3|<0.05
71041005|NCT02367872|141590474|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|70.38|||||TWO_SIDED|95.0|40.42|122.53||||||M-I: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||122.53|40.42|
71041006|NCT02367872|141590474|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|55.03|||||TWO_SIDED|95.0|31.61|95.81||||||M-I: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||95.81|31.61|
71041007|NCT02367872|141590474|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|125.96|||||TWO_SIDED|95.0|72.35|219.3||||||M-I: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||219.30|72.35|
71041008|NCT02367872|141590474|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|103.93|||||TWO_SIDED|95.0|59.7|180.95||||||M-I: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||180.95|59.70|
71041009|NCT02367872|141590474|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|91.97|||||TWO_SIDED|95.0|49.45|171.06||||||M-I: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||171.06|49.45|
71041010|NCT02367872|141590474|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|139.33|||||TWO_SIDED|95.0|74.91|259.15||||||M-I: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||259.15|74.91|
71041011|NCT02367872|141590475|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|51.39|||||TWO_SIDED|95.0|35.45|74.49||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||74.49|35.45|
71041012|NCT02367872|141590475|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|118.43|||||TWO_SIDED|95.0|81.7|171.68||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||171.68|81.70|
70997196|NCT04847141|141501817|SUPERIORITY||LS Mean Difference|-0.01||||0.4128|TWO_SIDED|95.0|-0.05|0.02||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 29||0.02|-0.05|0.4128
70997197|NCT04847141|141501819|SUPERIORITY||LS Mean Difference|-0.01||||0.9713|TWO_SIDED|95.0|-0.28|0.27||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 7||0.27|-0.28|0.9713
70997198|NCT04847141|141501819|SUPERIORITY||LS Mean Difference|0.07||||0.5985|TWO_SIDED|95.0|-0.2|0.35||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 7||0.35|-0.20|0.5985
70997199|NCT04847141|141501819|SUPERIORITY||LS Mean Difference|0.01||||0.9209|TWO_SIDED|95.0|-0.25|0.28||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 14||0.28|-0.25|0.9209
70997200|NCT04847141|141501819|SUPERIORITY||LS Mean Difference|-0.01||||0.9181|TWO_SIDED|95.0|-0.28|0.25||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 14||0.25|-0.28|0.9181
70997201|NCT04847141|141501819|SUPERIORITY||LS Mean Difference|0.15||||0.2443|TWO_SIDED|95.0|-0.11|0.41||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 29||0.41|-0.11|0.2443
70997202|NCT04847141|141501819|SUPERIORITY||LS Mean Difference|0.13||||0.3233|TWO_SIDED|95.0|-0.13|0.39||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 29||0.39|-0.13|0.3233
70997203|NCT04847141|141501820|SUPERIORITY||Difference in Percentage|3.0||||0.4676|TWO_SIDED|95.0|-5.3|11.5||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required at least 1 COVID-19 related MAV between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|||11.5|-5.3|0.4676
70997204|NCT04847141|141501820|SUPERIORITY||Difference in Percentage|4.9||||0.2507|TWO_SIDED|95.0|-3.6|13.4||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required at least 1 COVID-19 related MAV between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|||13.4|-3.6|0.2507
70997205|NCT04847141|141501821|SUPERIORITY||Difference in Percentage|0.1||||0.9744|TWO_SIDED|95.0|-3.8|4.0||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required hospital admission between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|||4.0|-3.8|0.9744
70997206|NCT04847141|141501821|SUPERIORITY||Difference in Percentage|2.7||||0.1878|TWO_SIDED|95.0|-1.6|7.5||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required hospital admission between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|||7.5|-1.6|0.1878
70997207|NCT04847141|141501822|SUPERIORITY||LS Mean Difference|0.01||||0.9485|TWO_SIDED|95.0|-0.38|0.4|||ANCOVA||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using ANCOVA model, including length of hospital stay as dependent variable \& treatment group as fixed effect, adjusting for baseline.|||0.40|-0.38|0.9485
70997208|NCT04847141|141501822|SUPERIORITY||LS Mean Difference|0.14||||0.4734|TWO_SIDED|95.0|-0.25|0.54|||ANCOVA||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using ANCOVA model, including length of hospital stay as dependent variable \& treatment group as fixed effect, adjusting for baseline.|||0.54|-0.25|0.4734
70997209|NCT04847141|141501823|SUPERIORITY||Difference in Percentage|0.02||||0.9853|TWO_SIDED|95.0|-3.05|3.12||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required ICU admission between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|||3.12|-3.05|0.9853
70997210|NCT04847141|141501823|SUPERIORITY||Difference in Percentage|0.01||||0.989|TWO_SIDED|95.0|-2.99|3.07||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required ICU admission between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|||3.07|-2.99|0.9890
70997211|NCT04847141|141501824|SUPERIORITY||LS Mean Difference|0.03||||0.578|TWO_SIDED|95.0|-0.07|0.12|||ANCOVA||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using ANCOVA model, including length of hospital stay as dependent variable \& treatment group as fixed effect, adjusting for baseline.|||0.12|-0.07|0.5780
70997212|NCT04847141|141501824|SUPERIORITY||LS Mean Difference|0.01||||0.9065|TWO_SIDED|95.0|-0.09|0.1|||ANCOVA||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using ANCOVA model, including length of hospital stay as dependent variable \& treatment group as fixed effect, adjusting for baseline.|||0.10|-0.09|0.9065
70997213|NCT04847141|141501828|SUPERIORITY||Difference in Percentage|0.02||||0.9853|TWO_SIDED|95.0|-3.05|3.12||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants with critical COVID-19 illness between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|||3.12|-3.05|0.9853
70997214|NCT04847141|141501828|SUPERIORITY||Difference in Percentage|0.01||||0.989|TWO_SIDED|95.0|-2.99|3.07||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants with critical COVID-19 illness between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|||3.07|-2.99|0.9890
70997215|NCT04507776|141501835|OTHER|||||||0.75|||||||t-test, 2 sided|||Year 1 Adherence: Baseline||||0.75
70997216|NCT04507776|141501835|OTHER||||||<|0.05|||||||t-test, 2 sided|||Year 1 Adherence: Year 1 (Month 12)||||<0.05
70997217|NCT04507776|141501835|OTHER||||||<|0.05|||||||t-test, 2 sided|||Year 7 Adherence: Baseline||||<0.05
70997218|NCT04507776|141501835|OTHER|||||||0.43|||||||t-test, 2 sided|||Year 7 Adherence: Year 7||||0.43
71041013|NCT02367872|141590475|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|272.83|||||TWO_SIDED|95.0|188.21|395.5||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||395.50|188.21|
70997219|NCT04507776|141501836|OTHER|||||||0.0001|||||||t-test, 2 sided|||Year 1 Adherence: Change at Year 1 (Month 12)||||0.0001
70997220|NCT04507776|141501836|OTHER|||||||0.247|||||||t-test, 2 sided|||Year 7 Adherence: Change at Year 7||||0.247
70997221|NCT04507776|141501837|OTHER|||||||0.21|||||||t-test, 2 sided|||Year 1 Adherence: Baseline||||0.21
70997222|NCT04507776|141501837|OTHER||||||<|0.05|||||||t-test, 2 sided|||Year 1 Adherence: Year 1 (Month 12)||||<0.05
70997223|NCT04507776|141501837|OTHER|||||||0.62|||||||t-test, 2 sided|||Year 7 Adherence: Baseline||||0.62
70997224|NCT04507776|141501837|OTHER|||||||0.18|||||||t-test, 2 sided|||Year 7 Adherence: Year 7||||0.18
70997225|NCT04507776|141501838|OTHER|||||||0.0001|||||||t-test, 2 sided|||Year 1 Adherence: Change at Year 1 (Month 12)||||0.0001
70997226|NCT04507776|141501838|OTHER|||||||0.003|||||||t-test, 2 sided|||Year 7 Adherence: Change at Year 7||||0.003
70997227|NCT00962754|141501841|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority since our hypothesis was that there would be no difference in outcome between the intervention and the control group.|Adjusted ratio of geometric means|1.0|||<|0.05|TWO_SIDED|95.0|0.81|1.19||"log transformation of mean duration of hospitalization,difference between two groups expressed as ratio of geometric means for duration. 95% confidence intervals calculated using bootstrapping method.~correction by linear regression model"|t-test, 2 sided|||We calculated that 85 patients in each group would give a power in excess of 85% to detect a difference of two days or more in the geometric mean length of hospital stay with a two-sided significance level of 0.05.||1.19|0.81|<0.05
70997228|NCT00132314|141501844|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.39|TWO_SIDED|95.0|0.63|1.2|||Log Rank|||Time-to-event analysis; The primary outcome hypothesis is tested using a two-sided log-rank test to compare the hazard rate for the IM treatment group to that for the oral treatment group.||1.20|0.63|0.39
70997229|NCT00132314|141501845|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.63|1.2||95% Confidence Interval: 0.63 to 1.20|Regression, Cox|||||1.20|0.63|
70997230|NCT03657810|141501857|SUPERIORITY||||||<|0.001|TWO_SIDED|95.0||||Type III P-Value are from the likelihood ration test from the logistic regression model with factors of treatment, gender, and investigator.|Regression, Logistic|||||||<0.001
70997231|NCT03657810|141501858|SUPERIORITY|||||||0.052|TWO_SIDED|95.0||||Type III P-Value are from the likelihood ration test from the logistic regression model with factors of treatment, gender, and investigator|Regression, Logistic|||||||0.052
70997232|NCT04426890|141501866|EQUIVALENCE|Therapeutic equivalence was declared if the two-sided 90% confidence interval (CI) for the treatment difference was entirely within an equivalence margin of \[-2.5, 2.0\].|Mean Difference (Net)|0.7|||||TWO_SIDED|90.0|-0.22|1.63||||||The statistical analysis of mean change from baseline in ISS7 at Week 12 between CT-P39 300 mg treatment arm (Arm 1) and Xolair 300 mg treatment arm (Arm 2), using ANCOVA with multiple imputation based on the MAR assumption was performed for the mITT Set.||1.63|-0.22|
70997233|NCT01082367|141501925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.55|||<|0.001|TWO_SIDED|95.0|4.67|99.52|||Regression, Logistic|||||99.52|4.67|<0.001
70997234|NCT02016898|141501928|OTHER||Risk Ratio (RR)|0.93||||0.7|TWO_SIDED|95.0|0.67|1.29|||Chi-squared|||||1.29|0.67|0.7
70997235|NCT02016898|141501929|OTHER||Median Difference (Final Values)|0.2|STANDARD_DEVIATION|2.01||0.539|TWO_SIDED||||||t-test, 1 sided|||||||0.539
70997236|NCT02151682|141501946|NON_INFERIORITY|A logistic regression model was fitted to the response using baseline pain, age group, treatment, and underlying pain condition as explanatory variables, followed by a Farrington-Manning test for non-inferiority, based on Full Analysis Set.|Risk Difference (RD)|-0.06||||0.079|TWO_SIDED|80.0|-0.19|0.06||The p-value is based on Farrington-Manning variance estimator using a pre-specified non-inferiority margin of -0.2. A 1-sided alpha of 0.1 was used. A p-value \<0.1 represents non-inferiority.|Farrington-Manning test|Non-inferiority of tapentadol prolonged-release versus morphine prolonged-release has been demonstrated.|A confidence interval for the risk difference (RD) completely above the pre-specified non-inferiority margin of -0.2 represents non-inferiority of tapentadol prolonged-release versus morphine prolonged-release.|||0.06|-0.19|0.0790
70997237|NCT01306032|141501966|SUPERIORITY_OR_OTHER|||||||0.034|||||||Log Rank|||||||0.034
70997238|NCT01306032|141501966|SUPERIORITY_OR_OTHER|||||||0.68|||||||Log Rank|||||||0.68
70997239|NCT00168064|141501977|NON_INFERIORITY_OR_EQUIVALENCE|The PG formulation was determined to be non-inferior to the AP formulation if the lower limit of the 95% confidence interval around the ratio of the response rates (PG/AP) was \> = 0.75.|ratio of proportions|1.226|||||TWO_SIDED|95.0|0.974|1.552|||ANCOVA||ratio is response rate of PG formulation divided by response rate of AP formulation|||1.552|0.974|
70997240|NCT05014542|141501983|SUPERIORITY||Mean Difference (Final Values)|-42.8|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC total of group A in Week 15) - mean (WOMAC total of group C in Week 15)|WOMAC total analysis between groups at Week 15. The Shapiro-Wilk test (S-W) was used for testing the normality of the data distribution. The comparability of groups regarding specified variables to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||<0.001
70997241|NCT05014542|141501984|SUPERIORITY||Mean Difference (Final Values)|-8.9|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC pain of group A at Week 15) - mean (WOMAC pain of group C at Week 15)|WOMAC pain analysis between groups at Week 15. The Shapiro-Wilk test (S-W) was used for testing the normality of the data distribution. The comparability of groups regarding specified variables to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at assessments.||||<.001
70997242|NCT05014542|141501985|SUPERIORITY||Mean Difference (Final Values)|-3.9|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC stiffness of group A at Week 15) - mean (WOMAC stiffness of group C at Week 15)|WOMAC stiffness between groups at Week 15. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups regarding specified variables to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||<0.001
70997243|NCT05014542|141501986|SUPERIORITY||Mean Difference (Final Values)|-30.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC functional disability of group A in Week 15) - mean (WOMAC functional disability of group C in Week 15)|WOMAC functional disability between groups at Week 15. The Shapiro-Wilk test (S-W) tests normality distribution. Furthermore, the comparability of groups regarding specified variables to accept or reject the null hypothesis of equality was tested with the Mann-Whitney U test, with a power of 95 % and a level of significance α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at specified assessment (the mid-spread).||||<0.001
70997244|NCT05014542|141501987|SUPERIORITY||Mean Difference (Final Values)|-48.4|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (VAS of group A in Week 15) - mean (VAS of group C in Week 15)|Visual Analogue Scale (VAS) was compared between groups at Week 15, when the acupuncture of group A ended. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) presented the statistical dispersion of sample data at specified assessments.||||<0.001
70997245|NCT05014542|141501988|SUPERIORITY||Mean Difference (Final Values)|-14.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (KDSQ of group A in Week 15) - mean (KDSQ of group C in Week 15)|The Kidney Deficiency Syndrome Questionnaire (KDSQ) was compared between groups in Week 15. The Shapiro-Wilk test (S-W) tests the normality of data distribution. The comparability of groups regarding the null hypothesis of similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were used to analyse the statistical dispersion of specified sample data at specified assessment.||||<0.001
71008550|NCT02055976|141525224|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-42.293|STANDARD_ERROR_OF_MEAN|3.587|<|0.001|TWO_SIDED|95.0|-49.417|-35.168|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the mixed-effect model for repeated measures (MMRM) model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-35.168|-49.417|<0.001
71041014|NCT02367872|141590475|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|184.13|||||TWO_SIDED|95.0|127.02|266.91||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||266.91|127.02|
70997246|NCT05014542|141501989|SUPERIORITY||Mean Difference (Final Values)|-774.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (DRUG of A group in Week 15) - mean (DRUG of C group in Week 15)|In Week 15, DRUG was compared between groups. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups regarding specified variables to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||<0.001
70997247|NCT05014542|141501990|SUPERIORITY||Mean Difference (Final Values)|0.009||||0.8493|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (A group L knee in Week 15) - mean (C group L knee in Week 15)|Active extension of left (L) knees in Week 15 in the between-group analysis. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||0.8493
70997248|NCT05014542|141501990|SUPERIORITY||Mean Difference (Final Values)|-0.107||||0.69654|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (A group R knee in Week 15) - mean (C group R knee in Week 15)|Active extension of the right (R) knees in Week 15 in the between-group analysis. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||0.69654
70997249|NCT05014542|141501991|SUPERIORITY||Mean Difference (Final Values)|3.9||||0.49|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (active flexion L knee of group A at Week 15) - mean (active flexion L knee of group C at Week 15)|L knee flexion between groups at Week 15. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||0.490
70997250|NCT05014542|141501991|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.517|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (active flexion R knee of group A at Week 15) - mean (active flexion R knee of group C at Week 15)|Right (R) knee flexion between groups in Week 15. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups regarding specified variables to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||0.517
70997251|NCT05014542|141501992|SUPERIORITY||Mean Difference (Final Values)|-3.0||||0.083|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of L upper leg of group A at Week 15) - mean (circumference of L upper leg of group C at Week 15)|Circumference of the left (L) upper leg between groups analysis at Week 15. For group normality statistics, the Shapiro-Wilk test (S-W) was used. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of specified sample data at specified assessment.||||0.083
70997252|NCT05014542|141501992|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.084|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of R upper leg of group A at Week 15) - mean (circumference of R upper leg of group C at Week 15)|Circumference of the right (R) upper leg between groups analysis at Week 15. For group normality statistics, the Shapiro-Wilk test (S-W) was used. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at specified assessments.||||0.084
70997253|NCT05014542|141501993|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.341|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of L knee of group A at Week 15) - mean (circumference of L knee of group C at Week 15)|Circumference of the left (L) knee in Week 15 was analysed between groups. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||0.341
70997254|NCT05014542|141501993|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.317|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of R knee of group A at Week 15) - mean (circumference of R knee of group C at Week 15)|Circumference of the right (R) knee in between groups at Week 15. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||0.317
70997255|NCT05014542|141501994|SUPERIORITY||Mean Difference (Final Values)|-33.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC total of group A in Week 24) -mean (WOMAC total of group C in Week 24)|WOMAC total was analysed in Week 24 between groups, nine weeks after acupuncture ended. The Shapiro-Wilk test (S-W) tested the normality of the distribution. The comparability of groups regarding specified variables to accept or reject the null hypothesis of equality was tested with the Mann-Whitney U test, with 95 % power and a level of significance α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of specified sample data at specified assessments.||||<0.001
70997256|NCT05014542|141501995|SUPERIORITY||Mean Difference (Final Values)|-6.5|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC pain of group A at Week 24) - mean (WOMAC pain of group C at Week 24)|WOMAC pain was analysed between groups 9 weeks after acupuncture ended in Week 24. The Shapiro-Wilk test (S-W) tested the normality distribution. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of specified sample data (the mid-spread).||||<.001
70997257|NCT05014542|141501996|SUPERIORITY||Mean Difference (Final Values)|-2.3|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC stiffness of group A in Week 24) - mean (WOMAC stiffness of group C in Week 24)|WOMAC stiffness between groups A and C in Week 24, 9 weeks after acupuncture ended. The Shapiro-Wilk test (S-W) tests the normality of distribution. Group comparability was tested with the Mann-Whitney U test with 95 % power and a level of significance α=0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of specified sample data at specified assessments.||||<0.001
70997258|NCT05014542|141501997|SUPERIORITY||Mean Difference (Final Values)|-24.3|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC functional disability of group A in Week 24) - mean (WOMAC functional disability of group C in Week 24)|WOMAC functional disability at Week 24 was analysed between groups. The Shapiro-Wilk test (S-W) tests the normality of data. The comparability of groups regarding specified variables (to accept or reject the null hypothesis of comparability) was tested with the Mann-Whitney U test with 95% power and a level of significance α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of specified sample data at specified assessments.||||<0.001
70997259|NCT05014542|141501998|SUPERIORITY||Mean Difference (Final Values)|-45.7|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (VAS in Week 24 of group A) - mean (VAS in Week 24 of group C)|VAS was compared between groups in Week 24. For group normality statistics, the Shapiro-Wilk test (S-W) was used. The comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data.||||<0.001
70997260|NCT05014542|141501999|SUPERIORITY||Mean Difference (Final Values)|-11.1|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (KDSQ in Week 24 of group A) - mean (KDSQ in Week 24 of group C)|KDSQ between groups in Week 24. For group normality statistics, the Shapiro-Wilk test (S-W) was used. The comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data.||||<0.001
70997261|NCT05014542|141502000|SUPERIORITY||Mean Difference (Final Values)|-581.5|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (DRUG in Week 24 of group A) - mean (DRUG in Week 24 of group C)|The DRUG between groups in Week 24. For group normality statistics, the Shapiro-Wilk test (S-W) was used. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data.||||<0.001
70997262|NCT05014542|141502001|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED||||||||mean (Act ext L of A group in Week 24) - mean (Act ext L of C group in Week 24)|Left (L) knee analysis between groups A and C in Week 24. For group normality statistics, the Shapiro-Wilk test (S-W) was used. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of comparability was tested with the Mann-Whitney U test, with 95% statistical power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at assessment.||||
70997263|NCT05014542|141502001|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED||||||||mean (Act ext R knee of A group in Week 24) - mean (Act ext R knee of C group in Week 24)|Right (R) knee analysis between groups at Week 24. For group normality statistics, the Shapiro-Wilk test (S-W) was used. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of comparability between groups was tested by the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at specified assessment.||||
71041015|NCT02367872|141590475|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|101.64|||||TWO_SIDED|95.0|69.04|149.64||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||149.64|69.04|
70997264|NCT05014542|141502002|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.953|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (L knee act flexion of group A in Week 24) - mean (L knee act flexion of group C in Week 24)|Left (L) knee flexion between groups at Week 24. The Shapiro-Wilk test (S-W) tests the normality of the distribution. Furthermore, the comparability of groups regarding specified variables to accept or reject the null hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a level of significance α = 0,05. Standard deviation (SD) was calculated to present the statistical dispersion of specified sample data at a specified assessment (time-point).||||0.953
71041016|NCT02367872|141590475|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|136.59|||||TWO_SIDED|95.0|92.78|201.09||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||201.09|92.78|
70997265|NCT05014542|141502002|SUPERIORITY||Mean Difference (Final Values)|1.8||||0.491|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (R knee act flexion of group A in Week 24) - mean (R knee act flexion of group C in Week 24)|Right (R) knee flexion between groups at Week 24. The Shapiro-Wilk test (S-W) tests the normality of the distribution. Furthermore, the comparability of groups regarding specified variables to accept or reject the null hypothesis of comparability was tested with the Mann-Whitney U test, with 95% power and a level of significance α = 0,05. Standard deviation (SD) was calculated to present the statistical dispersion of sample data at an assessment.||||0.491
71041017|NCT02367872|141590475|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|59.17|||||TWO_SIDED|95.0|33.99|102.99||||||M-I: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||102.99|33.99|
71041018|NCT02367872|141590475|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|97.04|||||TWO_SIDED|95.0|55.75|168.9||||||M-I: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||168.90|55.75|
70997266|NCT05014542|141502003|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.261|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of L upper leg of group A in Week 24) - mean (circumference of L upper leg of group C in Week 24)|Circumference of the left (L) upper leg between groups in Week 24. The Shapiro-Wilk test (S-W) was used to test the normality of a distribution. The comparability of groups regarding specified variables to accept or reject the hypothesis of groups comparability was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at assessments.||||0.261
70997267|NCT05014542|141502003|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.273|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of R upper leg of group A in Week 24) - mean (circumference of R upper leg of group C in Week 24)|Circumference of the R upper leg between groups at Week 24. The Shapiro-Wilk test (S-W) was used to test the normality of distribution. The comparability of groups regarding specified variables (null hypothesis) was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at assessments.||||0.273
70997268|NCT05014542|141502004|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.445|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of L knees in Week 24 of group A) - mean (circumference of L knees in Week 24 of group C)|Circumference of left (L) knees in Week 24, in between-groups. The Shapiro-Wilk test (S-W) tests normality distribution. The comparability of groups regarding specified variables to accept or reject the null hypothesis of similarity was tested with the Mann-Whitney U test with 95% power and a level of significance α = 0,05. Standard deviation was calculated to present the statistical dispersion of sample data at an assessment.||||0.445
70997269|NCT05014542|141502004|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.26|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of R knees in Week 24 of group A) - mean (circumference of R knees in Week 24 of group C)|Circumference of right (R) knees at Week 24 was analysed between groups. The Shapiro-Wilk test (S-W) tests normality distribution. The comparability of groups regarding specified variables to accept or reject the null hypothesis of similarity was tested with the Mann-Whitney U test with 95% power and a level of significance α = 0,05. Standard deviation was calculated to present the statistical dispersion of sample data at assessments.||||0.260
70997270|NCT05014542|141502005|SUPERIORITY||Mean Difference (Final Values)|-34.4|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC total of group A in Week 39) - mean (WOMAC total of group A in Week 0)|Western Ontario and McMaster University Osteoarthritis Index (WOMAC) total of group A in Week 39 (24 weeks after acupunctures ended) was compared with the pre-experimental baseline assessment by within-group analysis. The Shapiro-Wilk test (S-W) tests normality distribution. The null hypothesis at weeks 0 and 39 was tested with the Mann-Whitney U test with 95 % power and a level of significance α=0,05. Standard deviation (SD) was calculated to present the statistical dispersion of the sample.||||<0.001
70997271|NCT05014542|141502005|SUPERIORITY||Mean Difference (Final Values)|-39.1|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC total in Week 39 of group C) - mean (WOMAC total in Week 0 of group C).|WOMAC total of group C in Week 39 was tested for the significance level and mean difference by within-group analysis. The Shapiro-Wilk test (S-W) tests normality distribution. WOMAC total at Week 0 (pre-experimental baseline assessment) and Week 39 were compared to test the null hypothesis of group comparability by the Mann-Whitney U test with 95 % power and a level of significance α=0,05. Standard deviation (SD) was calculated to present the statistical dispersion of a sample.||||< 0.001
71041019|NCT02367872|141590475|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|260.03|||||TWO_SIDED|95.0|149.39|452.6||||||M-I: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||452.60|149.39|
71041020|NCT02367872|141590475|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|319.06|||||TWO_SIDED|95.0|183.31|555.34||||||M-I: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||555.34|183.31|
71041021|NCT02367872|141590475|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|130.07|||||TWO_SIDED|95.0|81.66|207.18||||||M-I: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||207.18|81.66|
71041022|NCT02367872|141590475|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|192.63|||||TWO_SIDED|95.0|120.94|306.83||||||M-I: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||306.83|120.94|
71041023|NCT02367872|141590476|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|60.22|||||TWO_SIDED|95.0|40.05|90.56||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||90.56|40.05|
70997272|NCT05014542|141502006|SUPERIORITY||Mean Difference (Final Values)|-6.2|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC pain in Week 39 of group A) - mean (WOMAC pain in Week 0 of group A)|The pain subscale of the WOMAC index of group A in Week 39 (24 weeks after acupunctures ended) was compared with baseline by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range and standard deviation were calculated to present the statistical dispersion of sample data at assessments.||||<0.001
70997273|NCT05014542|141502006|SUPERIORITY||Mean Difference (Final Values)|-7.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC pain in Week 39 of group C) - mean (WOMAC pain in Week 0 of group C)|The pain subscale of the WOMAC index of group C in Week 39 (end of acupuncture of group C) was compared with the pre-experimental baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range and standard deviation were calculated to present the statistical dispersion of data.||||<0.001
70997274|NCT05014542|141502007|SUPERIORITY||Mean Difference (Final Values)|-2.6|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC stiffness in Week 39 of group A) - mean (WOMAC stiffness in Week 0 of group A)|The stiffness subscale of the WOMAC index of group A in Week 39 (24 weeks after acupuncture of group A ended) was compared with the pre-experimental baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||<0.001
70997275|NCT05014542|141502007|SUPERIORITY||Mean Difference (Final Values)|-3.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC stiffness in Week 39 of group C) - mean (WOMAC stiffness in Week 0 of group C)|The stiffness subscale of the WOMAC index of group C in Week 39 (end of acupuncture of group C) was compared with the pre-experimental baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range and standard deviation were calculated to present the statistical dispersion of data.||||<0.001
70997276|NCT05014542|141502008|SUPERIORITY||Mean Difference (Final Values)|-25.3|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC functional disability in Week 39 of group A) - mean(WOMAC functional disability in Week 0 of group A)|The functional disability subscale of the WOMAC index of group A in Week 39 (24 weeks after acupuncture of group A ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||<0.001
71041024|NCT02367872|141590476|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|97.39|||||TWO_SIDED|95.0|64.77|146.46||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||146.46|64.77|
71041025|NCT02367872|141590476|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|111.6|||||TWO_SIDED|95.0|74.21|167.82||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||167.82|74.21|
71041026|NCT02367872|141590476|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|138.79|||||TWO_SIDED|95.0|92.29|208.7||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||208.70|92.29|
71041027|NCT02367872|141590476|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|135.18|||||TWO_SIDED|95.0|87.91|207.87||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||207.87|87.91|
70997277|NCT05014542|141502008|SUPERIORITY||Mean Difference (Final Values)|-29.6|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC functional disability in Week 39 of group C) - mean (WOMAC functional disability in Week 0 of group C)|The functional disability subscale of the WOMAC index of group C in Week 39 (when acupuncture of group A ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||<0.001
70997278|NCT05014542|141502009|SUPERIORITY||Mean Difference (Final Values)|-41.2|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (VAS in Week 39 of group A) - mean (VAS in Week 0 of group A)|VAS of group A in Week 39 (24 weeks after acupuncture of group A ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||<0.001
70997279|NCT05014542|141502009|SUPERIORITY||Mean Difference (Final Values)|-31.1|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (VAS in Week 39 of group C) - mean (VAS in Week 0 of group C)|VAS of group C in Week 39 (when acupuncture of group C ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||< 0.001
70997280|NCT05014542|141502010|SUPERIORITY||Mean Difference (Final Values)|-12.6|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (KDSQ in Week 39 of group A) - mean (KDSQ in Week 0 of group A)|KDSQ of group A in Week 39 (24 weeks after acupuncture of group A ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||<0.001
70997281|NCT05014542|141502010|SUPERIORITY||Mean Difference (Final Values)|-11.4|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (KDSQ in Week 39 of group C) - mean (KDSQ in Week 0 of group C)|KDSQ of group C in Week 39 (when acupuncture of group C ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||<0.001
70997282|NCT05014542|141502011|SUPERIORITY||Mean Difference (Final Values)|-361.4||||0.204|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (DRUG in Week 39 of group A) - mean (DRUG in Week 0 of group A)|The DRUG of group A in Week 39 (24 weeks after acupuncture of group A ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||0.204
70997283|NCT05014542|141502011|SUPERIORITY||Mean Difference (Final Values)|-305.4||||0.134|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (DRUG in Week 39 of group C) - mean (DRUG in Week 0 of group C)|The DRUG of group C in Week 39 (when acupuncture of group C ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||0.134
70997284|NCT05014542|141502012|SUPERIORITY||Mean Difference (Final Values)|-7.53|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (Lequesne index in Week 24 of A group) - mean (Lequesne index in Week 24 of C group)|The Lequesne index in Week 24 compared two confirmed comparable groups (at baseline), 9 weeks after acupuncture treatment in group A ended, while the C group was still a control. The Shapiro-Wilk test (S-W) tests normality distribution. The between-group comparability test at Week 24 was provided to accept or reject the null hypothesis by the Mann-Whitney U test, with 95 % power and a level of significance α = 0,05. Standard deviation (SD) was calculated to present the statistical dispersion.||||< 0.001
70997285|NCT00318565|141502048|SUPERIORITY_OR_OTHER||Binomial distribution|93.3||||0.05|ONE_SIDED|95.0|90.1||||Exact binomial distribution|||An acute success rate of 88% is anticipated and the one-sided 95% lower confidence bound will be compared to 80%. The statistical hypothesis for the primary efficacy endpoint is evaluated as a one-tailed hypothesis at a = 0.05.|||90.1|.05
70997286|NCT00318565|141502049|SUPERIORITY_OR_OTHER||Binomial Distribution|1.5||||0.05|ONE_SIDED|95.0||7.0|||Exact Binomial Distribution|||The anticipated rate of the CSAE is 2.7% and the one-sided 95% upper confidence bound will be compared to 7%||7||.05
70997287|NCT03589885|141502067|SUPERIORITY||Odds Ratio (OR)|1014.07|||<|0.0001|TWO_SIDED|95.0|68.83|14940.62|||Regression, Logistic|||PASI 75||14940.62|68.83|<0.0001
70997288|NCT03589885|141502067|SUPERIORITY||Odds Ratio (OR)|96.23|||<|0.0001|TWO_SIDED|95.0|17.22|537.78|||Regression, Logistic|||PASI 75||537.78|17.22|<0.0001
70997289|NCT03589885|141502068|SUPERIORITY||Odds Ratio (OR)|51.46|||<|0.0001|TWO_SIDED|95.0|11.95|221.64|||Regression, Logistic|||||221.64|11.95|<0.0001
70997290|NCT03589885|141502068|SUPERIORITY||Odds Ratio (OR)|29.7|||<|0.0001||95.0|7.38|119.57|||Regression, Logistic|||||119.57|7.38|<0.0001
70997291|NCT03589885|141502069|SUPERIORITY||Odds Ratio (OR)|88.46|||<|0.0001|TWO_SIDED|95.0|16.15|484.52|||Regression, Logistic|||||484.52|16.15|<0.0001
71041028|NCT02367872|141590476|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|323.75|||||TWO_SIDED|95.0|210.54|497.85||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||497.85|210.54|
70997292|NCT03589885|141502069|SUPERIORITY||Odds Ratio (OR)|37.9|||<|0.0001|TWO_SIDED|95.0|7.6|189.01|||Regression, Logistic|||||189.01|7.60|<0.0001
70997293|NCT00493974|141502078|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3876||95.0|||||Wilcoxon (Mann-Whitney)|||||||.3876
70997294|NCT00493974|141502079|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6413||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6413
70997295|NCT00493974|141502080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6433||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6433
70997296|NCT00493974|141502081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63||95.0|||||Chi-squared|||||||0.63
70997297|NCT00493974|141502082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4957||95.0|||||t-test, 2 sided|||||||0.4957
70997298|NCT00493974|141502083|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
70997299|NCT00493974|141502084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0|||||t-test, 2 sided|||||||0.006
70997300|NCT00599027|141502095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Endpoint after 28 days of treatment|ANCOVA|Overall treatment effect tested using F-test(alpha=0.05;two-sided). Diff between least square means of the 2 groups calculated with two-sided 95% C.I||||||0.001
70997301|NCT00476996|141502096|SUPERIORITY||Weighted Difference|20.4|||<|0.0001|TWO_SIDED|95.0|12.8|27.9|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||27.9|12.8|< 0.0001
70997302|NCT00476996|141502096|SUPERIORITY||Weighted Difference|25.2|||<|0.0001|TWO_SIDED|95.0|17.7|32.7|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||32.7|17.7|< 0.0001
70997303|NCT00476996|141502096|SUPERIORITY||Weighted Difference|29.1|||<|0.0001|TWO_SIDED|95.0|21.6|36.6|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||36.6|21.6|< 0.0001
70997304|NCT00476996|141502096|SUPERIORITY||Weighted Difference|30.3|||<|0.0001|TWO_SIDED|95.0|22.8|37.7|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||37.7|22.8|< 0.0001
71041029|NCT02367872|141590477|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|67.61|||||TWO_SIDED|95.0|42.17|108.39||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||108.39|42.17|
70997305|NCT00476996|141502097|SUPERIORITY||Weighted Difference|2.1||||0.1885|TWO_SIDED|95.0|-1.0|5.2|||Cochran-Mantel-Haenszel|||Analysis was stratified by region and baseline DMARD therapy||5.2|-1.0|0.1885
70997306|NCT00476996|141502097|SUPERIORITY||Weighted Difference|3.6||||0.033|TWO_SIDED|95.0|0.3|6.8|||Cochran-Mantel-Haenszel|||Analysis was stratified by region and baseline DMARD therapy||6.8|0.3|0.0330
70997307|NCT00476996|141502098|SUPERIORITY||Weighted Difference|4.2||||0.0175|TWO_SIDED|95.0|0.7|7.6|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||7.6|0.7|0.0175
70997308|NCT00476996|141502098|SUPERIORITY||Weighted Difference|4.3||||0.0134|TWO_SIDED|95.0|0.9|7.8|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||7.8|0.9|0.0134
70997309|NCT00476996|141502098|SUPERIORITY||Weighted Difference|10.5|||<|0.0001|TWO_SIDED|95.0|6.2|14.8|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||14.8|6.2|< 0.0001
70997310|NCT00476996|141502098|SUPERIORITY||Weighted Difference|10.5|||<|0.0001|TWO_SIDED|95.0|6.2|14.7|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||14.7|6.2|< 0.0001
70997311|NCT00476996|141502099|SUPERIORITY||Adjusted Mean Difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.3|||Analysis of Variance|||Week 24 analysis using adjusted mean difference. Model contains region, baseline DMARD therapy, baseline DAS28 score and treatment||-0.3|-0.8|< 0.0001
70997312|NCT00476996|141502099|SUPERIORITY||Adjusted Mean Difference|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.6|||Analysis of Variance|||Week 24 analysis using adjusted mean difference. Model contains region, baseline DMARD therapy, baseline DAS28 score and treatment||-0.6|-1.1|< 0.0001
70997313|NCT00476996|141502099|SUPERIORITY||Adjusted Mean Difference|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.7|||Analysis of Variance|||Week 48 analysis using adjusted mean difference. Model contains region, baseline DMARD therapy, baseline DAS28 score and treatment||-0.7|-1.2|< 0.0001
70997314|NCT00476996|141502099|SUPERIORITY||Adjusted Mean Difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.9|||Analysis of Variance|||Week 48 analysis using adjusted mean difference. Model contains region, baseline DMARD therapy, baseline DAS28 score and treatment||-0.9|-1.5|< 0.0001
70997315|NCT00476996|141502100|SUPERIORITY||Odds Ratio (OR)|2.6|||<|0.0001|TWO_SIDED|95.0|1.85|3.66|||Proportional Odds Analysis|||At Week 24, analysis was stratified by region and baseline DMARD therapy||3.66|1.85|< 0.0001
70997316|NCT00476996|141502100|SUPERIORITY||Odds Ratio (OR)|3.49|||<|0.0001|TWO_SIDED|95.0|2.49|4.91|||Proportional Odds Analysis|||At Week 24, analysis was stratified by region and baseline DMARD therapy||4.91|2.49|< 0.0001
70997317|NCT00476996|141502100|SUPERIORITY||Odds Ratio (OR)|4.18|||<|0.0001|TWO_SIDED|95.0|2.93|5.96|||Proportional Odds Analysis|||At Week 48, analysis was stratified by region and baseline DMARD therapy||5.96|2.93|< 0.0001
70997318|NCT00476996|141502100|SUPERIORITY||Odds Ratio (OR)|5.04|||<|0.0001|TWO_SIDED|95.0|3.54|7.18|||Proportional Odds Analysis|||At Week 48, analysis was stratified by region and baseline DMARD therapy||7.18|3.54|< 0.0001
70997319|NCT00476996|141502101|SUPERIORITY||Weighted Difference|13.2|||<|0.0001|TWO_SIDED|95.0|7.4|19.1|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||19.1|7.4|< 0.0001
70997320|NCT00476996|141502101|SUPERIORITY||Weighted Difference|16.2|||<|0.0001|TWO_SIDED|95.0|10.2|22.1|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||22.1|10.2|< 0.0001
70997321|NCT00476996|141502101|SUPERIORITY||Weighted Difference|19.3|||<|0.0001|TWO_SIDED|95.0|12.9|25.6|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||25.6|12.9|< 0.0001
70997322|NCT00476996|141502101|SUPERIORITY||Weighted Difference|20.8|||<|0.0001|TWO_SIDED|95.0|14.5|27.1|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||27.1|14.5|< 0.0001
70997323|NCT00476996|141502102|SUPERIORITY||Weighted Difference|4.6||||0.0203|TWO_SIDED|95.0|0.7|8.5|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||8.5|0.7|0.0203
70997324|NCT00476996|141502102|SUPERIORITY||Weighted Difference|6.7||||0.0014|TWO_SIDED|95.0|2.6|10.8|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||10.8|2.6|0.0014
70997325|NCT00476996|141502102|SUPERIORITY||Weighted Difference|6.6||||0.0042|TWO_SIDED|95.0|2.1|11.2|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||11.2|2.1|0.0042
70997326|NCT00476996|141502102|SUPERIORITY||Weighted Difference|13.4|||<|0.0001|TWO_SIDED|95.0|8.2|18.6|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||18.6|8.2|< 0.0001
70997327|NCT00476996|141502103|SUPERIORITY||Weighted Difference|19.4|||<|0.0001|TWO_SIDED|95.0|11.3|27.5|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||27.5|11.3|< 0.0001
70997328|NCT00476996|141502103|SUPERIORITY||Weighted Difference|24.7|||<|0.0001|TWO_SIDED|95.0|16.8|32.7|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||32.7|16.8|< 0.0001
70997329|NCT00476996|141502103|SUPERIORITY||Weighted Difference|27.2|||<|0.0001|TWO_SIDED|95.0|19.5|34.9|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||34.9|19.5|< 0.0001
70997330|NCT00476996|141502103|SUPERIORITY||Weighted Difference|27.6|||<|0.0001|TWO_SIDED|95.0|20.0|35.3|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||35.3|20.0|< 0.0001
70997331|NCT01181778|141502124|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage: Daily Pill|-0.4||||0.705|TWO_SIDED|95.0|-2.6|1.8|||Chi-squared|||Analysis of the difference in the percentage of participants who chose the Daily Pill before physician counseling and after physician counseling.||1.8|-2.6|0.705
70997332|NCT01181778|141502124|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage: Weekly Patch|3.8|||<|0.0001|TWO_SIDED|95.0|2.6|5.0|||Chi-squared|||Analysis of the difference in the percentage of participants who chose the Weekly Patch before physician counseling and after physician counseling.||5.0|2.6|<0.0001
70997333|NCT01181778|141502124|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage: Monthy Ring|16.0|||<|0.0001|TWO_SIDED|95.0|14.3|17.8|||Chi-squared|||Analysis of the difference in the percentage of participants who chose the Monthly Ring before physician counseling and after physician counseling.||17.8|14.3|<0.0001
70997334|NCT01181778|141502124|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage: Other Method|-3.6|||<|0.0001|TWO_SIDED|95.0|-5.0|-2.2|||Chi-squared|||Analysis of the difference in the percentage of participants who chose Other Method before physician counseling and after physician counseling.||-2.2|-5.0|<0.0001
70997335|NCT01181778|141502124|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage: Undecided|-15.8|||<|0.0001|TWO_SIDED|95.0|-17.6|-14.1|||Chi-squared|||Analysis of the difference in the percentage of participants who chose Undecided before physician counseling and after physician counseling.||-14.1|-17.6|<0.0001
70997336|NCT02455388|141502158|EQUIVALENCE|No equivalence margin set.|||||<|0.001|||||||Intraclass correlation coefficient|||||||<0.001
70997337|NCT02455388|141502159|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
70997338|NCT02455388|141502160|OTHER||Odds Ratio (OR)|1.7|||<|0.01|TWO_SIDED||||||Regression, Logistic|||||||<0.01
70997339|NCT01316939|141502162|SUPERIORITY_OR_OTHER||Percent difference of participants|-4.0|||||TWO_SIDED|95.0|-12.9|4.8||||||Placebo Vs GSK1605786A 500 mg once daily at Week 28 and 52||4.8|-12.9|
70997340|NCT01316939|141502162|SUPERIORITY_OR_OTHER||Percent difference of participants|-6.6|||||TWO_SIDED|95.0|-14.8|1.6||||||Placebo Vs GSK1605786A 500 mg BID at Week 28 and 52||1.6|-14.8|
70997341|NCT01316939|141502163|SUPERIORITY_OR_OTHER||Percent difference of participants|-4.0|||||TWO_SIDED|95.0|-12.2|4.2||||||Placebo Vs GSK1605786A 500 mg once daily at Week 28 and 52||4.2|-12.2|
70997342|NCT01316939|141502163|SUPERIORITY_OR_OTHER||Percent difference of participants|-5.3|||||TWO_SIDED|95.0|-13.1|2.6||||||||2.6|-13.1|
70997343|NCT01016678|141502193|SUPERIORITY_OR_OTHER||Difference in percentages|18.0||||0.0038|TWO_SIDED||||||Chi-squared|||Comparison of percentage of participants pain free at 2 hours post-dose (active) to percentage of participants pain free at 2 hours post-dose (placebo)||||0.0038
70997344|NCT01016678|141502194|SUPERIORITY_OR_OTHER||difference in percentages|8.0||||0.1294|TWO_SIDED||||||Chi-squared|||||||0.1294
70997345|NCT00093470|141502232|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||0.026|TWO_SIDED|95.0|0.538|1.072||one-sided p-value; threshold for statistical significance \<0.025|Log Rank|stratified log rank test|Hazard ratio of DFS for Arm A to Arm B|||1.072|0.538|0.026
70997346|NCT00093470|141502233|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.809||||0.056|TWO_SIDED|95.0|0.567|1.155||one-sided p-value; threshold for statistical significance \< 0.025|Log Rank|stratified log rank test|Hazard ratio of OS for Arm A to Arm B|||1.155|0.567|0.056
70997347|NCT00877006|141502244|SUPERIORITY_OR_OTHER|||||||0.0005||||||P-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment group, region, preassigned standard treatment, and lymphoma type as factors and baseline value as the covariate.|ANCOVA|||The hypothesis of interest is superiority of BR over standard treatment.||||0.0005
70997348|NCT00877006|141502245|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9677|TWO_SIDED|95.0|0.58|1.68|||Log Rank|Stratified log-rank test by preassigned standard treatment and lymphoma type.|BR/RCHOP-RCVP|||1.68|0.58|0.9677
70997349|NCT02034552|141502262|SUPERIORITY|||||||0.0109||||||\[80% CI\]: \[10.1%- 39.6%\]|Clopper and Pearson|Patient bone scan response rate at Week 24 will be estimated with exact binomial 80% CI using the method of Clopper and Pearson.||H0: Patient bone scan response rate at Week 24 ≤5%. The Type I error rate for the test in each treatment group, is one-sided 0.10. A one-sided p-value will be reported for this test.||||0.0109
70997350|NCT02034552|141502262|SUPERIORITY||||||<|0.0001||||||\[80% CI\]: \[40.8% - 73.7%\]|Clopper and Pearson|Patient bone scan response rate at Week 24 will be estimated with exact binomial 80% CI using the method of Clopper and Pearson.||H0: Patient bone scan response rate at Week 24 ≤5%. The Type I error rate for the test in each treatment group, is one-sided 0.10. A one-sided p-value will be reported for this test.||||<0.0001
70997351|NCT02034552|141502262|SUPERIORITY||||||<|0.0001||||||\[80% CI\]: \[31.8% - 68.2%\]|Clopper and Pearson|Patient bone scan response rate at Week 24 will be estimated with exact binomial 80% CI using the method of Clopper and Pearson.||H0: Patient bone scan response rate at Week 24 ≤5%. The Type I error rate for the test in each treatment group, is one-sided 0.10. A one-sided p-value will be reported for this test.||||<0.0001
70997352|NCT01779648|141502296|SUPERIORITY_OR_OTHER|||||||0.785||95.0|||||Chi-squared|||||||0.785
70997353|NCT01779648|141502297|SUPERIORITY_OR_OTHER|||||||0.195||95.0|||||t-test, 2 sided|||Mean of right and left leg values were compared between the two device groups.||||0.195
70997354|NCT01779648|141502298|SUPERIORITY_OR_OTHER|||||||0.722||95.0|||||t-test, 2 sided|||Mean of right and left leg values were compared between the two device groups.||||0.722
70997355|NCT01779648|141502299|SUPERIORITY_OR_OTHER|||||||0.158||95.0|||||t-test, 2 sided|||Mean of right and left leg values were compared between the two device groups.||||0.158
70997356|NCT01779648|141502300|SUPERIORITY_OR_OTHER|||||||0.301||95.0|||||t-test, 2 sided|||Mean of right and left leg values were compared between the two device groups.||||0.301
70997357|NCT01779648|141502301|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Age, sex, body mass index, and baseline TVF (total volume flow) are controlled as fixed-effects parameters.||||||<0.001
70997358|NCT01779648|141502302|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Age, sex, body mass index, and baseline PVF (peak volume flow) are controlled as fixed-effects parameters.||||||<0.001
70997359|NCT01779648|141502303|SUPERIORITY_OR_OTHER|||||||0.929||95.0|||||Mixed Models Analysis|Age, sex, body mass index, and baseline PV (peak velocity)are controlled as fixed-effects parameters.||||||0.929
70997360|NCT01779648|141502305|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Mixed Models Analysis|Age, sex, body mass index, and baseline peak volume flow are controlled as fixed-effects parameters.||||||0.008
70997361|NCT01779648|141502306|SUPERIORITY_OR_OTHER|||||||0.132||95.0|||||Mixed Models Analysis|Age, sex, body mass index, and baseline total volume flow are controlled as fixed-effects parameters.||||||0.132
70997362|NCT03325556|141502335|SUPERIORITY||Hazard Ratio (HR)|0.353|STANDARD_ERROR_OF_MEAN|0.3676||0.0023|TWO_SIDED|95.0|0.172|0.727||1-sided p-value reported. The protocol-defined O'Brien Flemming stopping boundary for the planned IA was a 1-sided p-value equal to 0.0033|Regression, Cox||Model included covariates for Treatment group, dementia subtype, and region, and robust sandwich-type variance estimator.|||0.727|0.172|0.0023
70997363|NCT03325556|141502336|SUPERIORITY||Hazard Ratio (HR)|0.452|STANDARD_ERROR_OF_MEAN|0.2812||0.0024|TWO_SIDED|95.0|0.261|0.785||1-sided p-value|Regression, Cox||Model included covariates for Treatment group, dementia subtype, and region, and robust sandwich-type variance estimator.|||0.785|0.261|0.0024
70997364|NCT02119026|141502349|SUPERIORITY|||||||0.967|||||||Mantel Haenszel|||||||0.967
71041030|NCT02367872|141590477|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|63.7|||||TWO_SIDED|95.0|39.73|102.12||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||102.12|39.73|
71041031|NCT02367872|141590477|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|84.45|||||TWO_SIDED|95.0|52.67|135.38||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||135.38|52.67|
71041032|NCT02367872|141590477|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|108.54|||||TWO_SIDED|95.0|67.7|174.01||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||174.01|67.70|
71041033|NCT02367872|141590477|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|113.25|||||TWO_SIDED|95.0|69.62|184.24||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||184.24|69.62|
71041034|NCT02367872|141590477|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|312.89|||||TWO_SIDED|95.0|192.34|509.0||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||509.00|192.34|
70997365|NCT02119026|141502350|SUPERIORITY|||||||0.474|||||||Mantel Haenszel|||||||0.474
70997366|NCT02119026|141502351|SUPERIORITY|||||||0.464|||||||Mantel Haenszel|||||||0.464
70997367|NCT02119026|141502352|SUPERIORITY|||||||0.854|||||||Fisher Exact|||||||0.854
70997368|NCT02119026|141502353|SUPERIORITY|||||||0.728|||||||Mantel Haenszel|||||||0.728
70997369|NCT02119026|141502354|SUPERIORITY|||||||0.668|||||||Mantel Haenszel|||||||0.668
70997370|NCT02119026|141502355|SUPERIORITY|||||||0.618|||||||Mantel Haenszel|||||||0.618
70997371|NCT02119026|141502356|SUPERIORITY|||||||0.792||||||The rate of overall response was measured as the response rate from randomization until the day of documented complete response (CR) or partial response (PR) (whichever status is recorded first). Analysis corresponds to numbers of CR and PR.|Wilcoxon (Mann-Whitney)|||||||0.792
70997372|NCT02119026|141502357|SUPERIORITY|||||||0.371||||||The rate of overall response was measured as the response rate from randomization until the day of documented complete response (CR) or partial response (PR) (whichever status is recorded first). Analysis corresponds to numbers of CR and PR.|Wilcoxon (Mann-Whitney)|||||||0.371
70997373|NCT03004976|141502373|OTHER||Wilcoxon Mann-Whitney Odds|0.9|STANDARD_ERROR_OF_MEAN|0.248||0.71|TWO_SIDED|95.0|0.53|1.55||Wilcoxon Two Sample Test|Wilcoxon (Mann-Whitney)|||Primary efficacy analysis (mRS shift from baseline to 90 days)||1.55|0.53|0.71
70997374|NCT03004976|141502373|OTHER||Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.223||0.87|TWO_SIDED|95.0|0.4|2.3|||Cumulative Logit Proportional Odds Model|||Additional analysis of the primary endpoint (mRS score at 90 days), adjusted for baseline mRS, baseline NIHSS, and institution.||2.3|0.4|0.87
70997375|NCT00291499|141502397|SUPERIORITY||Mean Difference (Final Values)|-8.7||||0.016|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.016
70997376|NCT00291499|141502398|SUPERIORITY||Mean Difference (Final Values)|-2.14||||0.008|TWO_SIDED||||||t-test, 2 sided|||||||0.008
70997377|NCT00291499|141502399|SUPERIORITY|||||||0.043||||||Threshold p \<0.05|Cochran-Mantel-Haenszel|||||||0.043
70997378|NCT00291499|141502400|SUPERIORITY|||||||0.132||||||Threshold p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.132
71041035|NCT02367872|141590478|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|60.68|||||TWO_SIDED|95.0|40.35|91.27||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||91.27|40.35|
71041036|NCT02367872|141590478|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|98.01|||||TWO_SIDED|95.0|65.17|147.41||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||147.41|65.17|
70997379|NCT00291499|141502401|SUPERIORITY|||||||0.031||||||Threshold p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.031
70997380|NCT00291499|141502402|SUPERIORITY||Mean Difference (Final Values)|0.363|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70997381|NCT03807245|141502405|OTHER||||||<|0.0001|||||||ANOVA|||Adjusted geometric mean fold increase from Day 1 to Day 85: adjusted geometric mean ratio GBS-NN/NN2 25mcg/placebo||||<0.0001
70997382|NCT03807245|141502405|OTHER||||||<|0.0001|||||||ANOVA|||Adjusted geometric mean fold increase from Day 1 to Day 85: adjusted geometric mean ratio GBS-NN/NN2 50mcg/placebo||||<0.0001
70997383|NCT01807949|141502431|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|2.62||||0.0004|TWO_SIDED|95.0|1.18|4.06|||MMRM|||Analysis was performed using mixed-effects model for repeated measures (MMRM) model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (less than \[\<\] 18 versus greater than equal to \[\>=\]18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||4.06|1.18|0.0004
70997384|NCT01807949|141502431|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0|||<|0.0001|TWO_SIDED|95.0|1.56|4.44|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||4.44|1.56|<0.0001
70997385|NCT01807949|141502432|SUPERIORITY_OR_OTHER||LS Mean Difference|4.42||||0.0007|TWO_SIDED|95.0|1.86|6.98|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||6.98|1.86|0.0007
71041037|NCT02367872|141590478|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|111.68|||||TWO_SIDED|95.0|74.25|167.96||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||167.96|74.25|
71041038|NCT02367872|141590478|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|139.7|||||TWO_SIDED|95.0|92.88|210.11||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||210.11|92.88|
70997386|NCT01807949|141502432|SUPERIORITY_OR_OTHER||LS Mean Difference|5.25|||<|0.0001|TWO_SIDED|95.0|2.69|7.81|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||7.81|2.69|<0.0001
70997387|NCT01807949|141502433|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|||<|0.0001|TWO_SIDED|95.0|0.23|0.59|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline BMI.||0.59|0.23|<0.0001
70997388|NCT01807949|141502433|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36||||0.0001|TWO_SIDED|95.0|0.17|0.54|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||0.54|0.17|0.0001
70997389|NCT01807949|141502434|SUPERIORITY_OR_OTHER||LS Mean Difference|2.21||||0.1651|TWO_SIDED|95.0|-0.91|5.33|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline CFQ-R respiratory domain score.||5.33|-0.91|0.1651
70997390|NCT01807949|141502434|SUPERIORITY_OR_OTHER||LS Mean Difference|2.85||||0.0736|TWO_SIDED|95.0|-0.27|5.98|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||5.98|-0.27|0.0736
70997391|NCT01807949|141502435|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9568|||<|0.0001|TWO_SIDED|95.0|1.8829|4.6431||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Cochran-Mantel-Haenszel|||Odds Ratio (OR) and 95% confidence intervals (Cis) are Mantel-Haenszel estimates. P values are from a Cochran-Mantel-Haenszel test stratified by sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||4.6431|1.8829|<0.0001
70997392|NCT01807949|141502435|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3834||||0.0001|TWO_SIDED|95.0|1.5234|3.7286||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Cochran-Mantel-Haenszel|||Analysis was performed as described in Statistical Analysis 1.||3.7286|1.5234|0.0001
70997393|NCT01807949|141502436|SUPERIORITY_OR_OTHER||Event Rate Ratio|0.6912||||0.0116|TWO_SIDED|95.0|0.5187|0.9209||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Negative Binomial Regression|||Analysis was performed using regression analysis for a negative binomial distribution with sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70) as covariates with the logarithm of time on study as the offset.||0.9209|0.5187|0.0116
70997394|NCT01807949|141502436|SUPERIORITY_OR_OTHER||Event Rate Ratio|0.5659||||0.0002|TWO_SIDED|95.0|0.4191|0.7641||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Negative Binomial Regression|||Analysis was performed as described in Statistical Analysis 1.||0.7641|0.4191|0.0002
70997395|NCT01807949|141502437|SUPERIORITY_OR_OTHER||LS Mean Difference|1.13|||<|0.0001|TWO_SIDED|95.0|0.62|1.64|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline weight.||1.64|0.62|<0.0001
70997396|NCT01807949|141502437|SUPERIORITY_OR_OTHER||LS Mean Difference|0.95||||0.0003|TWO_SIDED|95.0|0.43|1.46|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||1.46|0.43|0.0003
70997397|NCT01807949|141502438|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2313||||0.0005|TWO_SIDED|95.0|0.1037|0.3589|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline BMI z-score.||0.3589|0.1037|0.0005
70997398|NCT01807949|141502438|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2217||||0.0006|TWO_SIDED|95.0|0.0961|0.3473|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||0.3473|0.0961|0.0006
70997399|NCT01807949|141502439|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.716||||0.0384|TWO_SIDED||||||Cox Proportional Hazard Regression|||Analysis was performed using Cox proportional hazard regression, time is the time-to-first event or censoring, with adjustment for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||||0.0384
70997400|NCT01807949|141502439|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.533||||0.0003|TWO_SIDED||||||Cox Proportional Hazard Regression|||Analysis was performed as described in Statistical Analysis 1.||||0.0003
70997401|NCT01807949|141502440|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6373||||0.0393|TWO_SIDED|95.0|0.416|0.9764|||Cochran-Mantel-Haenszel|||OR and 95% confidence intervals (CIs) are Mantel-Haenszel estimates. P values are from a Cochran-Mantel-Haenszel test stratified by sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||0.9764|0.4160|0.0393
70997402|NCT01807949|141502440|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4429||||0.0002|TWO_SIDED|95.0|0.2863|0.6851|||Cochran-Mantel-Haenszel|||Analysis was performed as described in Statistical Analysis 1.||0.6851|0.2863|0.0002
70997403|NCT01807949|141502441|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0028||||0.7679|TWO_SIDED|95.0|-0.0211|0.0156|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline EQ-5D-3L index score.||0.0156|-0.0211|0.7679
70997404|NCT01807949|141502441|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0009||||0.9214|TWO_SIDED|95.0|-0.0192|0.0174|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||0.0174|-0.0192|0.9214
70997405|NCT01807949|141502442|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4||||0.1034|TWO_SIDED|95.0|-0.5|5.3|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline EQ-5D-3L VAS score.||5.3|-0.5|0.1034
70997406|NCT01807949|141502442|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3||||0.0262|TWO_SIDED|95.0|0.4|6.2|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||6.2|0.4|0.0262
70997407|NCT01807949|141502443|SUPERIORITY_OR_OTHER||LS Mean Difference|8.64||||0.0005|TWO_SIDED|95.0|3.77|13.51|||MMRM|||Effectiveness: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM effectiveness score.||13.51|3.77|0.0005
70997408|NCT01807949|141502443|SUPERIORITY_OR_OTHER||LS Mean Difference|11.61|||<|0.0001|TWO_SIDED|95.0|6.75|16.48|||MMRM|||Effectiveness: analysis was performed as described in Statistical Analysis 1.||16.48|6.75|<0.0001
70997409|NCT01807949|141502443|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.18||||0.0403|TWO_SIDED|95.0|-6.21|-0.14|||MMRM|||Side Effects: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM side effects score.||-0.14|-6.21|0.0403
70997410|NCT01807949|141502443|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.29||||0.0054|TWO_SIDED|95.0|-7.31|-1.28|||MMRM|||Side Effects: analysis was performed as described in Statistical Analysis 1.||-1.28|-7.31|0.0054
70997411|NCT01807949|141502443|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||1|TWO_SIDED|95.0|-4.07|4.07|||MMRM|||Convenience: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM convenience score.||4.07|-4.07|1.0000
70997412|NCT01807949|141502443|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.8777|TWO_SIDED|95.0|-3.74|4.37|||MMRM|||Convenience: analysis was performed as described in Statistical Analysis 1.||4.37|-3.74|0.8777
70997413|NCT01807949|141502443|SUPERIORITY_OR_OTHER||LS Mean Difference|4.64||||0.0668|TWO_SIDED|95.0|-0.32|9.61|||MMRM|||Global Satisfaction: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM global satisfaction score.||9.61|-0.32|0.0668
70997414|NCT01807949|141502443|SUPERIORITY_OR_OTHER||LS Mean Difference|7.16||||0.0045|TWO_SIDED|95.0|2.23|12.08|||MMRM|||Global Satisfaction: analysis was performed as described in Statistical Analysis 1.||12.08|2.23|0.0045
70997415|NCT01899677|141502453|SUPERIORITY_OR_OTHER|||||||0.32|||||||Mann whitney U|||Mann Whitney U test was used to compare cytokine levels between groups.||||0.32
70997416|NCT01899677|141502454|SUPERIORITY_OR_OTHER|||||||0.73|||||||Mann whitney U|||||||0.73
71041039|NCT02367872|141590478|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|135.08|||||TWO_SIDED|95.0|87.75|207.92||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||207.92|87.75|
71041040|NCT02367872|141590478|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|325.28|||||TWO_SIDED|95.0|211.32|500.7||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||500.70|211.32|
71041041|NCT02625298|141590490|OTHER||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
71041042|NCT05068284|141590492|SUPERIORITY||Risk Difference (RD)|7.1|||||TWO_SIDED|95.0|-6.3|20.6|||||Risk difference = (ABBV-154 - placebo)|||20.6|-6.3|
71041043|NCT05068284|141590492|SUPERIORITY||Risk Difference (RD)|33.3|||||TWO_SIDED|95.0|6.7|60.0|||||Risk difference = (ABBV-154 - placebo)|||60.0|6.7|
71041044|NCT05068284|141590492|SUPERIORITY||Risk Difference (RD)|28.6|||||TWO_SIDED|95.0|4.9|52.2|||||Risk difference = (ABBV-154 - placebo)|||52.2|4.9|
71041045|NCT05068284|141590492|SUPERIORITY||Risk Difference (RD)|27.3|||||TWO_SIDED|95.0|1.0|53.6|||||Risk difference = (ABBV-154 - placebo)|||53.6|1.0|
71041046|NCT05068284|141590493|SUPERIORITY||Risk Difference (RD)|11.9|||||TWO_SIDED|95.0|-19.8|43.6|||||Risk difference = (ABBV-154 - placebo)|||43.6|-19.8|
71041047|NCT05068284|141590493|SUPERIORITY||Risk Difference (RD)|29.5|||||TWO_SIDED|95.0|-4.8|63.8|||||Risk difference = (ABBV-154 - placebo)|||63.8|-4.8|
71041048|NCT05068284|141590493|SUPERIORITY||Risk Difference (RD)|19.0|||||TWO_SIDED|95.0|-13.7|51.8|||||Risk difference = (ABBV-154 - placebo)|||51.8|-13.7|
71041049|NCT05068284|141590493|SUPERIORITY||Risk Difference (RD)|23.3|||||TWO_SIDED|95.0|-13.6|60.3|||||Risk difference = (ABBV-154 - placebo)|||60.3|-13.6|
71041050|NCT05068284|141590494|SUPERIORITY||Risk Difference (RD)|11.3|||||TWO_SIDED|95.0|-18.5|41.0|||||Risk difference = (ABBV-154 - placebo)|||41.0|-18.5|
71041051|NCT05068284|141590494|SUPERIORITY||Risk Difference (RD)|38.5|||||TWO_SIDED|95.0|5.0|71.9|||||Risk difference = (ABBV-154 - placebo)|||71.9|5.0|
71041052|NCT05068284|141590494|SUPERIORITY||Risk Difference (RD)|24.6|||||TWO_SIDED|95.0|-7.0|56.2|||||Risk difference = (ABBV-154 - placebo)|||56.2|-7.0|
71041053|NCT05068284|141590494|SUPERIORITY||Risk Difference (RD)|39.2|||||TWO_SIDED|95.0|3.8|74.5|||||Risk difference = (ABBV-154 - placebo)|||74.5|3.8|
71041054|NCT00493792|141590538|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.47|TWO_SIDED|95.0|0.29|1.77|||Regression, Cox|||||1.77|0.29|0.47
71041055|NCT00493792|141590539|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.06|TWO_SIDED|95.0|0.23|1.03|||Regression, Cox|||||1.03|0.23|0.06
71041056|NCT00493792|141590540|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.193|TWO_SIDED|95.0|0.45|1.18|||Regression, Cox|||||1.18|.45|0.193
71041057|NCT00685035|141590546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_DEVIATION|0.23||0.02|TWO_SIDED|95.0|||||ANCOVA|||||||.02
71041058|NCT04241133|141590550|OTHER|The experimental and control groups were not compared due to the inability to collect post data with the control group because of stay at home orders during the COVID-19 pandemic.|||||<|0.05||||||The reported P-value was calculated.|t-test, 2 sided|The a priori threshold for statistical significance was P\<0.05.||The experimental group was tested for significant difference in Healthy Eating Index 2015 (HEI-2015) scores at baseline and 12 weeks. SAS macros provided by the National Cancer Institute were used to compute HEI-2015 scores for each dietary recall at pre- (baseline) and post-intervention (12 weeks) using the Simple HEI Scoring Algorithm.||||<0.05
71041059|NCT02104817|141590551|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.837|TWO_SIDED|95.0|0.9|1.09||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.|Regression, Cox|||||1.09|0.90|0.837
71041060|NCT02104817|141590552|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.269|TWO_SIDED|95.0|0.84|1.05||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.|Regression, Cox|||||1.05|0.84|0.269
71041061|NCT02104817|141590553|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.402|TWO_SIDED|95.0|0.93|1.19||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing|Regression, Cox|||||1.19|0.93|0.402
71041062|NCT02104817|141590554|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.94|TWO_SIDED|95.0|0.87|1.16||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing|Regression, Cox|||||1.16|0.87|0.940
71041063|NCT02104817|141590555|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.092|TWO_SIDED|95.0|0.81|1.02||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing|Regression, Cox|||||1.02|0.81|0.092
71041064|NCT02104817|141590556|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.016|TWO_SIDED|95.0|0.75|0.97||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.|Regression, Cox|||||0.97|0.75|0.016
71041065|NCT02104817|141590557|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.372|TWO_SIDED|95.0|0.9|1.31||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing|Regression, Cox|||||1.31|0.90|0.372
71041066|NCT02104817|141590558|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.336|TWO_SIDED|95.0|0.89|1.41||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.|Regression, Cox|||||1.41|0.89|0.336
70997417|NCT01899677|141502455|SUPERIORITY_OR_OTHER|||||||0.66|||||||Mann whitney U|||||||0.66
70923787|NCT04850807|141339355|SUPERIORITY||average marginal effect|-1.4|STANDARD_ERROR_OF_MEAN|3.6|<|0.05|TWO_SIDED|95.0|-8.5|5.6|||Differences-in-Differences regression||||"Results are adjusted for baseline medication use, age, sex, race, activities of daily living score, cognitive function score, psychotic diagnosis, depression, anxiety, dementia, asthma, ARBS score, treatment group.~The model includes a random intercept for nursing home."|5.6|-8.5|<0.05
70923788|NCT04850807|141339356|SUPERIORITY||average marginal effect|-4.8|STANDARD_ERROR_OF_MEAN|2.5|<|0.05|TWO_SIDED|95.0|-9.8|0.1|||Differences-in-Differences regression||||"Fixed effect covariates: baseline medication use, age, sex, race, activities of daily living score, cognitive function score, psychotic diagnosis, depression, anxiety, dementia, asthma, ARBS score, treatment group.~Random effects: random intercept for nursing home Imputed Outcomes: 37 Control Follow-Up , 35 Treatment Follow-Up"|0.1|-9.8|<0.05
70923789|NCT04850807|141339358|SUPERIORITY||average marginal effect|-0.31|||<|0.05|TWO_SIDED|95.0|-1.03|0.41|||Differences-in-Differences regression||||"Fixed effect covariates: age, sex, race, activities of daily living score, cognitive function score, psychotic disorder, bipolar disease, depression, anxiety, dementia, alzheimer's diagnosis, antidepressant use, antianxietal use, antipsychotic use, history of heart failure, baseline ARBS (exclusive to CMAI/PHQ-9 model), baseline CMAI (exclusive to ARBS/PHQ-9 model), indicator of baseline/follow-up score, treatment group, interaction of treatment group and baseline/follow-up score.~Random effects: random intercept for nursing home, random intercept for the interaction of baseline/follow-up measure and nursing home, and random intercept for individual.~Imputed Outcomes: 37 Control Follow-Up (Both CMAI and ARBS), 37 Treatment Follow-Up (ABRS), 35 Treatment Follow-Up (CMAI)"|0.41|-1.03|<0.05
70923790|NCT02278562|141339359|SUPERIORITY|||||||0.37||||||0.05 is the a priori threshold for statistical significance|Wilcoxon Rank-Sum|||Prior data indicate that LDR is normally distributed with standard deviation ranging from 0.16 to 0.23 in hemodialysis and control patients, respectively. If the true difference in the experimental and control means is 0.21, we will be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.933. The Type I error probability associated with this test of this null hypothesis is 0.05.||||0.37
70923791|NCT02278562|141339359|SUPERIORITY|||||||0.955||||||0.05 is the a priori threshold for statistical significance|Wilcoxon Rank-Sum|||Prior data indicate that LDR is normally distributed with standard deviation ranging from 0.16 to 0.23 in hemodialysis and control patients, respectively. If the true difference in the experimental and control means is 0.21, we will be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.933.||||0.955
70923792|NCT02187003|141339362|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.7944|TWO_SIDED|95.0|0.77|1.22|||Log Rank|||A Cox proportional hazards regression model with age group and genotype group as stratification covariates was used to estimate the hazard ratio (Placebo/Rivipansel) and the corresponding 95 percent (%) confidence interval (CI). A stratified log-rank test with age group and genotype group as stratification variables was performed to evaluate P value.||1.22|0.77|0.7944
70923793|NCT02187003|141339363|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.7156|TWO_SIDED|95.0|0.77|1.19|||Log Rank|||A Cox proportional hazards regression model with age group and genotype group as stratification covariates was used to estimate the hazard ratio (Placebo/Rivipansel) and the corresponding 95% CI. A stratified log-rank test with age group and genotype group as stratification variables was performed to evaluate P- value.||1.19|0.77|0.7156
70923794|NCT02187003|141339364|SUPERIORITY||Mean Difference (Net)|-0.06||||0.852|TWO_SIDED|95.0|-1.27|0.88|||ANCOVA|||The difference in medians (Rivipansel- Placebo) was estimated by the difference of treatment medians from summary statistics. The corresponding 95% CI was estimated by a bootstrap method with stratification for age and genotype groups. P-value was from analysis of covariance (ANCOVA) model based on rank-transformed values using age group and genotype group as the stratification covariates.||0.88|-1.27|0.8520
70923795|NCT02187003|141339365|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.8593|TWO_SIDED|95.0|0.82|1.26|||Log Rank|||A Cox proportional hazards regression model with age group and genotype group as stratification covariates was used to estimate the hazard ratio (Placebo/Rivipansel) and the corresponding 95% CI. A stratified log-rank test with age group and genotype group as stratification variables was performed to evaluate P- value.||1.26|0.82|0.8593
70923796|NCT02187003|141339366|SUPERIORITY||Median Difference (Final Values)|-0.02||||0.9332|TWO_SIDED|95.0|-0.13|0.16|||ANCOVA|||The difference in medians (Rivipansel- Placebo) was estimated by the difference of treatment medians from summary statistics. The corresponding 95% CI was estimated by a bootstrap method with stratification for age and genotype groups. P value was from ANCOVA model based on rank-transformed values using age group and genotype group as the stratification covariates.||0.16|-0.13|0.9332
70923797|NCT02187003|141339367|SUPERIORITY||Difference in percentage of participants|-1.17||||0.5349|TWO_SIDED|95.0|-5.19|2.46|||Chan and Zhang|||P values and 95% CI for the difference in percentages were based on the exact method by Chan and Zhang.||2.46|-5.19|0.5349
70923798|NCT02187003|141339374|SUPERIORITY||Risk Difference (RD)|-3.336||||0.302|TWO_SIDED|95.0|-10.024|2.968|||Chan and Zhang|||||2.968|-10.024|0.3020
70923799|NCT02187003|141339375|SUPERIORITY||Risk Difference (RD)|1.203||||0.5429|TWO_SIDED|95.0|-2.379|5.104|||Chan and Zhang|||||5.104|-2.379|0.5429
70923800|NCT02379156|141339397|SUPERIORITY||||||<|0.001|||||||ANOVA|||Between-group differences in the change in core body temperature (Tcore) from baseline (BL) values to after cold exposure (Cold) were analyzed using a Mixed Model ANOVA. We hypothesized that participants with tetraplegia would have a greater decrease in Tcore when exposed to cool ambient temperature than control participants exposed to the same cool ambient temperature.||||<0.001
70923801|NCT02379156|141339397|SUPERIORITY|||||||0.006|||||||ANOVA|||Within-group differences in the change in (Tcore) in the participants with tetraplegia from BL values to Cold, with and without a dose of 10 mg of midodrine (two separate visits), were analyzed using a Repeated Measures ANOVA .||||0.006
70923802|NCT02379156|141339398|SUPERIORITY|||||||0.042|||||||t-test, 2 sided|||Between-group differences in the percent change in total WAIS IV scores from BL to after cold ambient exposure were analyzed using an independent samples T-test. We hypothesized that participants with tetraplegia would have a greater percent change in total WAIS IV scores due to impaired cognitive function post cool ambient exposure.||||.042
70997418|NCT01899677|141502456|SUPERIORITY_OR_OTHER|||||||0.76|||||||Mann whitney U|||||||0.76
70997419|NCT00118911|141502471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.631|STANDARD_DEVIATION|7.337|<|0.03|TWO_SIDED|95.0|-8.3|-0.963|||ANCOVA|We used multiple imputation.||Hypothesis was that CBT would be superior to RES||-0.963|-8.30|<.03
70997420|NCT00118911|141502472|SUPERIORITY_OR_OTHER||Slope|-0.12|STANDARD_DEVIATION|0.59|>|0.05|TWO_SIDED|95.0|-0.41|0.18|||Mixed Models Analysis||Those who were assigned to CBT and made a partial or full response maintained their gains over follow-up|We examined whether those in the CBT condition maintained their gains over time. Analysis was restricted to those assigned to CBT who were responders or partial responders.||.18|-.41|>.05
70997421|NCT03037307|141502497|OTHER||Least square (LS) mean difference|2.76|||<|0.0001|TWO_SIDED|95.0|1.89|3.63||Treatment Comparison for study validity.|ANCOVA|ANCOVA: factors for participant (random effect); period \& treatment, participant-level \& period-level pre-treatment baseline bite force as covariates.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||3.63|1.89|<.0001
70997422|NCT03037307|141502498|OTHER||Least Square (LS) mean difference|2.12|||<|0.0001|TWO_SIDED|95.0|1.25|3.0|||ANCOVA|ANCOVA: factors for participant (random effect); period \& treatment, participant-level \& period-level pre-treatment baseline bite force as covariates|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||3.00|1.25|<.0001
70997423|NCT01700985|141502538|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
70997424|NCT01700985|141502539|SUPERIORITY||||||<|0.0001||||||At Day 15.|Fisher Exact|||||||<0.0001
70997425|NCT01700985|141502540|SUPERIORITY||||||<|0.0001||||||At Day 15.|Fisher Exact|||||||<0.0001
70997426|NCT05067452|141502549|SUPERIORITY||Slope|-0.092|STANDARD_ERROR_OF_MEAN|0.721||0.9|TWO_SIDED|95.0|-1.59|1.4|||ANCOVA|||||1.40|-1.59|0.900
70997427|NCT05067452|141502550|SUPERIORITY||Slope|1.37|STANDARD_ERROR_OF_MEAN|0.945||0.146|TWO_SIDED|95.0|-0.478|3.23|||Mixed Models Analysis|||||3.23|-0.478|0.146
70997428|NCT05067452|141502551|SUPERIORITY||Risk Difference (RD)|0.235|STANDARD_ERROR_OF_MEAN|0.212||0.281|TWO_SIDED|95.0|-0.207|0.677|||ANCOVA|Linear regression used with the binary outcome (linear probability model)||||0.677|-0.207|0.281
70997429|NCT05067452|141502552|SUPERIORITY||Risk Difference (RD)|0.354|STANDARD_ERROR_OF_MEAN|0.211||0.094|TWO_SIDED|95.0|-0.06|0.768|||Mixed Models Analysis|Linear regression used with the binary outcome (linear probability model)||||0.768|-0.060|0.094
70997430|NCT05067452|141502553|SUPERIORITY||Slope|2.18|STANDARD_ERROR_OF_MEAN|5.11||0.669|TWO_SIDED|95.0|-7.83|12.2|||Mixed Models Analysis|||||12.2|-7.83|0.669
71041067|NCT02104817|141590559|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.112|TWO_SIDED|95.0|0.97|1.31||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.|Regression, Cox|||||1.31|0.97|0.112
70997431|NCT05067452|141502554|SUPERIORITY||Slope|-0.024|STANDARD_ERROR_OF_MEAN|0.367||0.949|TWO_SIDED|95.0|-0.695|0.743|||Mixed Models Analysis|||||0.743|-0.695|0.949
70997432|NCT05067452|141502555|SUPERIORITY||Slope|-0.54|STANDARD_ERROR_OF_MEAN|0.53||0.308|TWO_SIDED|95.0|-1.58|0.679|||Mixed Models Analysis|||||0.679|-1.58|0.308
70997433|NCT05067452|141502556|SUPERIORITY||Slope|-1.02|STANDARD_ERROR_OF_MEAN|1.91||0.593|TWO_SIDED|95.0|-4.77|0.499|||Mixed Models Analysis|||||0.499|-4.77|0.593
70997434|NCT05067452|141502557|SUPERIORITY||Slope|-2.63|STANDARD_ERROR_OF_MEAN|1.65||0.112|TWO_SIDED|95.0|-5.86|0.611|||Mixed Models Analysis|||||0.611|-5.86|0.112
70997435|NCT05067452|141502560|SUPERIORITY||Slope|-2.66|STANDARD_ERROR_OF_MEAN|2.85||0.349|TWO_SIDED|95.0|-8.25|2.92|||Mixed Models Analysis|||||2.92|-8.25|0.349
70997436|NCT00067470|141502571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|92.0|STANDARD_ERROR_OF_MEAN|40.0||0.025||95.0|11.0|172.0|||Regression, Linear|||||172|11|0.025
70997437|NCT00067470|141502572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.7|STANDARD_ERROR_OF_MEAN|2.9||0.053||95.0|-0.1|11.5|||Regression, Linear|The raw data were adjusted for the observed differences in baseline between the groups and fitted to a longitudinal repeated measures linear model.||||11.5|-0.1|0.053
70997438|NCT03859960|141502574|OTHER|||||||0.006|||||||Pearson correlation test|||||||0.006
70997439|NCT03859960|141502574|OTHER|||||||0.23||||||p\<0.05 was considered statisticaly significant.|Pearson correlation test|||||||0.23
70997440|NCT03859960|141502575|OTHER|||||||0.001||||||p\<0.05 was considered statisticaly significant.|Pearson correlation test|||||||0.001
70997441|NCT03859960|141502575|OTHER|||||||0.731|||||||Pearson correlation test|||||||0.731
70997442|NCT03859960|141502576|OTHER|||||||0.214|||||||Pearson correlation test|||||||0.214
70997443|NCT03859960|141502576|OTHER|||||||0.993||||||p\<0.05 was considered statisticaly significant.|Pearson correlation test|||||||0.993
70997444|NCT03859960|141502577|OTHER|||||||0.41|||||||Pearson correlation test|||||||0.41
70997445|NCT03859960|141502577|OTHER|||||||0.676|||||||Pearson correlation test|||||||0.676
70997446|NCT03859960|141502578|OTHER|||||||0.511||||||p\<0.05 was considered statisticaly significant.|Pearson correlation test|||||||0.511
70997447|NCT03859960|141502578|OTHER|||||||0.248|||||||Pearson correlation test|||||||0.248
70997448|NCT03859960|141502579|OTHER|||||||0.654|||||||Pearson correlation test|||||||0.654
70997449|NCT03859960|141502579|OTHER|||||||0.025|||||||Pearson correlation test|||||||0.025
70997450|NCT01192204|141502583|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED|||||Statistical analyses reflect percent change intrapatient pre versus post histologic grade scores|Wilcoxon matched-pairs signed rank test|We used a 2-tailed Mann Whitney U test to evaluate these data.||Wilcoxon matched-pairs signed rank test (intrapatient pre versus post treatment scores)||||0.048
71041068|NCT02104817|141590560|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.091|TWO_SIDED|95.0|0.97|1.42||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.|Regression, Cox|||||1.42|0.97|0.091
71041069|NCT02104817|141590561|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.408|TWO_SIDED|95.0|0.83|1.08||This endpoint was not in the testing sequence and therefore not under type I error control.|Regression, Cox|||||1.08|0.83|0.408
71041070|NCT02104817|141590562|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.233|TWO_SIDED|95.0|0.63|1.12||This endpoint was not in the testing sequence and therefore not under type I error control.|Regression, Cox|||||1.12|0.63|0.233
71041071|NCT02104817|141590563|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.77|TWO_SIDED|95.0|0.81|1.17||This endpoint was not in the testing sequence and therefore not under type I error control.|Regression, Cox|||||1.17|0.81|0.770
71100231|NCT02662582|141709114|SUPERIORITY||LSMean difference|0.7||||0.28|TWO_SIDED|90.0|-0.38|1.77||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.77|-0.38|0.280
71100232|NCT02662582|141709114|SUPERIORITY||LSMean difference|0.46||||0.424|TWO_SIDED|90.0|-0.49|1.4||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.40|-0.49|0.424
71100233|NCT02662582|141709115|SUPERIORITY||LSMean difference|0.039||||0.187|TWO_SIDED|90.0|-0.0099|0.0879||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0879|-0.0099|0.187
71100234|NCT02662582|141709115|SUPERIORITY||LSMean difference|0.0488||||0.213|TWO_SIDED|90.0|-0.0163|0.114||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.1140|-0.0163|0.213
71100235|NCT02662582|141709116|SUPERIORITY||LSMean difference|-0.4||||0.64||90.0|-2.1|1.2||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.2|-2.1|0.640
71100236|NCT02662582|141709116|SUPERIORITY||LSMean difference|-0.7||||0.487|TWO_SIDED|90.0|-2.5|1.1||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.1|-2.5|0.487
71041072|NCT02104817|141590564|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.278|TWO_SIDED|95.0|0.9|1.45||This endpoint was not in the testing sequence and therefore not under type I error control.|Regression, Cox|||||1.45|0.90|0.278
71041073|NCT01225055|141590565|SUPERIORITY|||||||0.84||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA||||||0.84
71041074|NCT01225055|141590565|SUPERIORITY|||||||0.64||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA||||||0.64
71041075|NCT01225055|141590565|SUPERIORITY|||||||0.26||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA||||||0.26
71041076|NCT01225055|141590566|SUPERIORITY|||||||0.64||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA||||||0.64
71100237|NCT02662582|141709117|SUPERIORITY||LSMean difference|0.095||||0.1|TWO_SIDED|90.0|0.0|0.189||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.189|0.000|0.100
71100238|NCT02662582|141709117|SUPERIORITY||LSMean difference|0.133||||0.008|TWO_SIDED|90.0|0.053|0.213||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.213|0.053|0.008
71100239|NCT02662582|141709118|SUPERIORITY||LSMean difference|0.051||||0.408|TWO_SIDED|90.0|-0.052|0.154||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.154|-0.052|0.408
71100240|NCT02662582|141709118|SUPERIORITY||LSMean difference|0.094||||0.058|TWO_SIDED|90.0|0.013|0.174||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.174|0.013|0.058
71100241|NCT02662582|141709119|SUPERIORITY||LSMean difference|1.44||||0.648|TWO_SIDED|90.0|-3.85|6.73||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||6.73|-3.85|0.648
71100242|NCT02662582|141709119|SUPERIORITY||LSMean difference|0.85||||0.775|TWO_SIDED|90.0|-4.12|5.82||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||5.82|-4.12|0.775
70997451|NCT01192204|141502583|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|||||Statistical analyses reflect percent change pre versus post histologic grade scores|Wilcoxon matched-pairs signed rank test|||Wilcoxon matched-pairs signed rank test (pre versus post treatment scores)||||0.50
70997452|NCT01192204|141502584|SUPERIORITY_OR_OTHER||||||<|0.002|TWO_SIDED||||||Wilcoxon matched-pairs signed rank test|specifically, we used the Wilcoxon matched-pairs signed rank test.||||||<0.002
71041077|NCT01225055|141590566|SUPERIORITY|||||||0||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA||||||0.00
71041078|NCT01225055|141590566|SUPERIORITY|||||||0.09||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA||||||0.09
71041079|NCT01225055|141590567|SUPERIORITY|||||||0.72||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA||||||0.72
71041080|NCT01225055|141590567|SUPERIORITY|||||||0.58||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA||||||0.58
71041081|NCT01225055|141590567|SUPERIORITY|||||||0.44||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA||||||0.44
71041082|NCT01225055|141590568|SUPERIORITY|||||||0.02||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA||||||0.02
71041083|NCT01225055|141590568|SUPERIORITY|||||||0.1||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA||||||0.10
71041084|NCT01225055|141590568|SUPERIORITY|||||||0.04||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA||||||0.04
70997453|NCT01192204|141502584|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED||||||Wilcoxon matched-pairs signed rank test|||||||0.036
70997454|NCT01192204|141502585|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||2-tailed unpaired t test|||||||0.002
70997455|NCT01192204|141502585|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||two-tailed unpaired t test|||||||0.16
70997456|NCT02146248|141502586|SUPERIORITY_OR_OTHER|||||||0.4795||||||The two-tailed P value equals 0.4795|McNemar|||McNemar paired. Hypothesis is no change in tubal patency status. All subjects know to have bilateral patency in one of the exams during natural cycle||||0.4795
71041085|NCT01225055|141590569|SUPERIORITY|||||||0.01||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA||||||0.01
71041086|NCT01225055|141590569|SUPERIORITY|||||||0.34||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA||||||0.34
71041087|NCT01225055|141590569|SUPERIORITY|||||||0.2||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA||||||0.20
71041088|NCT01225055|141590570|SUPERIORITY|||||||0||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA||||||0.00
71041089|NCT01225055|141590570|SUPERIORITY|||||||0.01||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA||||||0.01
71041090|NCT01225055|141590570|SUPERIORITY|||||||0.04||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA||||||0.04
71041091|NCT00687739|141590590|SUPERIORITY|The primary analysis compared the GnRHAG + E2 and GnRHAG + PL groups, pooled across exercise status. It was acknowledged that the inclusion of exercisers could minimize the effects of GnRHAG but would be reflective of the effects of ovarian hormone suppression on sedentary and active women. Differences in changes across time between groups were tested using an analysis of covariance model conditioned on baseline.|||||<|0.05||||||The p value was calculated|ANCOVA|||The primary analysis was the effect of PL vs E2 collapsed across exercise (2-group comparison). The analysis of effects of exercise was exploratory (evaluated within-group changes only).||||<0.05
71041092|NCT00687739|141590591|SUPERIORITY||||||<|0.05||||||The p value was calculated|ANCOVA|||The primary analysis was the comparison of within-group changes in the E2 and placebo groups for cortisol AUC in response to Dex/CRH and between-group differences in the changes. Within-group changes and between-group differences in changes were evaluated by linear contrast using an ANCOVA model with adjustment for pre-intervention values of outcomes.||||<0.05
71041093|NCT00687739|141590592|SUPERIORITY||||||<|0.05||||||The p value was calculated|ANCOVA|||The primary analysis compared the GnRHag+E2 and GnRHag+PL groups, pooled across exercise status. Differences in change over time between groups were tested by using an ANCOVA model, first with treatment group alone, and again adding FM and FFM to the model.||||<0.05
71041094|NCT00766493|141590651|SUPERIORITY_OR_OTHER||Proportion|0.043|STANDARD_ERROR_OF_MEAN|0.013||0.0001|TWO_SIDED|95.0|0.021|0.077||Reject H0 if z\<-1.96, or 1-sided p\<0.025.|One Sample Binomial|Significance test was based on a one-sample normal approximation to the binomial test.|The 2-sided 95% CI is reported for descriptive purposes; the statistical hypothesis test is 1-sided.|"This study is designed to test the primary null hypothesis that the composite MAE outcome of all death, stroke, and/or MI when using the GORE Embolic Filter is equal to or higher than a Performance Goal (PG) of 6.4% established from published carotid stenting studies utilizing distal embolic protection, versus the alternative hypothesis that the composite MAE outcome is less than the performance goal.~The sample size was calculated based on 80% power and a 1-sided Type I error rate of 0.025."||0.077|0.021|0.0001
71041095|NCT00721955|141590658|SUPERIORITY|LS mean was used in the primary efficacy analysis|||||<|0.0001||||||p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA|||||||<0.0001
70997457|NCT01861054|141502638|OTHER|||||||0.3149||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups|Wilcoxon (Mann-Whitney)|||Comparison on ALDH+ cells by ALDEFLUOR assay||||0.3149
70997458|NCT01861054|141502638|OTHER|||||||0.8148||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|Wilcoxon (Mann-Whitney)|||Comparison on CD44+/CD24- by flow citometry||||0.8148
70997459|NCT01861054|141502639|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||Phospho AKT Extent||||>0.9999
70997460|NCT01861054|141502639|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||Phospho-AKT Intensity||||>0.9999
70997461|NCT01861054|141502639|OTHER|||||||0.2245|||||||Wilcoxon (Mann-Whitney)|||AKT Extent||||0.2245
70997462|NCT01861054|141502639|OTHER|||||||0.5785|||||||Wilcoxon (Mann-Whitney)|||AKT Intensity||||0.5785
70997463|NCT01861054|141502639|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||Phospho-FAK Extent||||>0.9999
70997464|NCT01861054|141502639|OTHER|||||||0.3139|||||||Wilcoxon (Mann-Whitney)|||Phospho-FAK Intensity||||0.3139
70997465|NCT01861054|141502639|OTHER|||||||0.212|||||||Wilcoxon (Mann-Whitney)|||FAK Extent||||0.2120
70997466|NCT01861054|141502639|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||FAK Intensity||||>0.9999
70997467|NCT01861054|141502639|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||C-PTEN Extent||||>0.9999
70997468|NCT01861054|141502639|OTHER|||||||0.8728|||||||Wilcoxon (Mann-Whitney)|||C-PTEN Intensity||||0.8728
71041096|NCT00721955|141590658|SUPERIORITY|p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|||||<|0.0001||||||p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA|||||||<0.0001
70997469|NCT01861054|141502639|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||D-PTEN Extent||||>0.9999
70997470|NCT01861054|141502639|OTHER|||||||0.8728|||||||Wilcoxon (Mann-Whitney)|||D-PTEN Intensity||||0.8728
70997471|NCT01861054|141502639|OTHER|||||||0.2265|||||||Wilcoxon (Mann-Whitney)|||CXCR1 Extent||||0.2265
70997472|NCT01861054|141502639|OTHER|||||||0.2403|||||||Wilcoxon (Mann-Whitney)|||CXCR1 Intensity||||0.2403
70997473|NCT01861054|141502640|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups|Wilcoxon (Mann-Whitney)|||Interleukin 1 Beta||||>0.9999
70997474|NCT01861054|141502640|OTHER|||||||0.6945||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups|Wilcoxon (Mann-Whitney)|||Interleukin 6||||0.6945
70997475|NCT01861054|141502640|OTHER|||||||0.9448||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|Wilcoxon (Mann-Whitney)|||Interleukin 8||||0.9448
70997476|NCT01861054|141502640|OTHER|||||||0.6292||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|Wilcoxon (Mann-Whitney)|||Tumor Necrosis Factor - alpha||||0.6292
70997477|NCT01861054|141502640|OTHER|||||||0.2354||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|Wilcoxon (Mann-Whitney)|||Granulocyte Macrophage Colony Stm Factor||||0.2354
70997478|NCT01861054|141502640|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|Wilcoxon (Mann-Whitney)|||Vascular Endothelial Growth Factor||||>0.9999
70997479|NCT01861054|141502640|OTHER|||||||0.4719||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|Wilcoxon (Mann-Whitney)|||Basic Fibroblast Growth Factor||||0.4719
70997480|NCT01861054|141502641|OTHER|||||||0.0951|||||||Wilcoxon (Mann-Whitney)|||CD31 Extent||||0.0951
70997481|NCT01861054|141502641|OTHER|||||||0.1643|||||||Wilcoxon (Mann-Whitney)|||CD31 Intensity||||0.1643
70997482|NCT01861054|141502642|OTHER|||||||0.4183|||||||Wilcoxon (Mann-Whitney)|||P62 Extent||||0.4183
70997483|NCT01861054|141502642|OTHER|||||||0.3702|||||||Wilcoxon (Mann-Whitney)|||P62 Intensity||||0.3702
70997484|NCT01861054|141502647|OTHER|||||||0.6168||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Lymphocyte in WBC||||0.6168
70997485|NCT01861054|141502647|OTHER|||||||0.6168||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Total T cell in lymphocytes||||0.6168
70997486|NCT01861054|141502647|OTHER|||||||0.1453||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||B cell in lymphocytes||||0.1453
70997487|NCT01861054|141502647|OTHER|||||||0.1453||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||T-helper cell in lymphocytes||||0.1453
70997488|NCT01861054|141502647|OTHER|||||||0.1453||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||CTL in lymphocytes||||0.1453
70997489|NCT01861054|141502647|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||NKT cell in lymphocytes||||>0.9999
70997490|NCT01861054|141502647|OTHER|||||||0.7634||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||ADCC NK subsets in lymphocytes||||0.7634
70997491|NCT01861054|141502647|OTHER|||||||0.5487||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Regulatory NK subsets in lymphocytes||||0.5487
70997492|NCT01861054|141502647|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Exhausted NK subsets in lymphocytes||||>0.9999
70997493|NCT01861054|141502647|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||CD56-CD16+ NK subsets in lymphocytes||||>0.9999
71041097|NCT00721955|141590659|SUPERIORITY|LS mean was used in the primary efficacy analysis|||||<|0.0001||||||p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA|||||||<0.0001
71041098|NCT00721955|141590659|SUPERIORITY||||||<|0.0001||||||-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA|||||||<0.0001
71041099|NCT01589601|141590687|SUPERIORITY||Mean Difference (Net)|4.8719||||0.1641|TWO_SIDED|95.0|-2.0289|11.7728|||Mixed Models Analysis|Baseline||||11.7728|-2.0289|0.1641
71041100|NCT01589601|141590687|SUPERIORITY|6 Months|Mean Difference (Net)|9.4938||||0.0299|TWO_SIDED|95.0|0.9406|18.047|||Mixed Models Analysis|||||18.0470|0.9406|0.0299
71041101|NCT01589601|141590688|SUPERIORITY||Mean Difference (Net)|2.7157||||0.5531|TWO_SIDED|95.0|-6.3054|11.7368|||Mixed Models Analysis|Baseline||||11.7368|-6.3054|0.5531
71041102|NCT01589601|141590688|SUPERIORITY||Mean Difference (Net)|11.773||||0.035|TWO_SIDED|95.0|0.8409|22.7052|||Mixed Models Analysis|6 Months||||22.7052|0.8409|0.0350
71041103|NCT01589601|141590689|SUPERIORITY|HADS Anxiety 2 weeks|Mean Difference (Net)|-1.2436||||0.1592|TWO_SIDED|95.0|-2.9817|0.4945|||Mixed Models Analysis|||||0.4945|-2.9817|0.1592
71041104|NCT01589601|141590689|SUPERIORITY|HADS Anxiety 3 months|Mean Difference (Net)|-0.7946||||0.3657|TWO_SIDED|95.0|-2.5285|0.9393|||Mixed Models Analysis|||||0.9393|-2.5285|0.3657
71041105|NCT01589601|141590689|SUPERIORITY|HADS Anxiety 6 months|Mean Difference (Net)|-1.8269||||0.048|TWO_SIDED|95.0|-3.6375|-0.0164|||Mixed Models Analysis|||||-0.0164|-3.6375|0.0480
71041106|NCT01589601|141590689|SUPERIORITY|HADS Depression at 2 weeks|Mean Difference (Net)|-0.9097||||0.2372|TWO_SIDED|95.0|-2.4253|0.6058|||Mixed Models Analysis|||||0.6058|-2.4253|0.2372
71041107|NCT01589601|141590689|SUPERIORITY|HADS Depression 3 months|Mean Difference (Net)|-0.6592||||0.4237|TWO_SIDED|95.0|-2.2862|0.9678|||Mixed Models Analysis|||||0.9678|-2.2862|0.4237
71041108|NCT01589601|141590689|SUPERIORITY|HADS Depression at 6 months|Mean Difference (Net)|-1.9379||||0.0202|TWO_SIDED|95.0|-3.5672|-0.3085|||Mixed Models Analysis|||||-0.3085|-3.5672|0.0202
71100243|NCT02662582|141709120|SUPERIORITY||LSMean difference|1.1||||0.544|TWO_SIDED|90.0|-1.9|4.0||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||4.0|-1.9|0.544
71041109|NCT01589601|141590691|SUPERIORITY|FACIT-Sp at 2 weeks|Mean Difference (Net)|0.9413||||0.5857|TWO_SIDED|95.0|-2.4666|4.3493|||Mixed Models Analysis|||||4.3493|-2.4666|0.5857
71041110|NCT01589601|141590691|SUPERIORITY|FACIT-Sp at 3 months|Mean Difference (Net)|1.1174||||0.5655|TWO_SIDED|95.0|-2.7246|4.9594|||Mixed Models Analysis|||||4.9594|-2.7246|0.5655
71041111|NCT01589601|141590691|SUPERIORITY|FACIT-Sp at 6 months|Mean Difference (Net)|3.9809||||0.0271|TWO_SIDED|95.0|0.4581|7.5036|||Mixed Models Analysis|||||7.5036|0.4581|0.0271
71041112|NCT01589601|141590693|SUPERIORITY|All-cause readmissions, Poisson regression with log link and Pearson scale||||||0.56|||||||Poisson regression|||||||0.56
71041113|NCT01589601|141590693|SUPERIORITY|Cardiovascular readmissions, Poisson regression with log link and Pearson scale||||||0.8|||||||Poisson regression|||||||0.80
71041114|NCT01589601|141590693|SUPERIORITY|Heart failure readmissions, Poisson regression with log link and Pearson scale||||||0.92|||||||Poisson regression|||||||0.92
71041115|NCT01589601|141590693|SUPERIORITY|Non-cardiovascular readmissions, Poisson regression with log link and Pearson scale||||||0.12|||||||Poisson regression|||||||0.12
71041116|NCT00434837|141590711|SUPERIORITY|||||||0.27|||||||ANOVA|||These results are from the 3-year analysis.||||.27
71041117|NCT00434837|141590712|SUPERIORITY|||||||0.08|||||||ANOVA|||These results are from the 7-year analysis.||||.08
71041118|NCT00434837|141590713|SUPERIORITY|||||||0.22|||||||ANOVA|||These results are from the 15-year analysis.||||.22
71041119|NCT00434837|141590714|SUPERIORITY|||||||0.0078|||||||ANOVA|||These results are from the 15-year analysis.||||.0078
71041120|NCT00434837|141590715|SUPERIORITY|||||||0.0018|||||||ANOVA|||These results are from the 15-year analysis.||||.0018
71041121|NCT00434837|141590716|SUPERIORITY|||||||0.015|||||||ANOVA|||These results are from the 15-year analysis.||||.015
71041122|NCT00434837|141590717|SUPERIORITY|||||||0.003|||||||ANOVA|||These results are from the 15-year analysis.||||.003
71041123|NCT00434837|141590718|SUPERIORITY|||||||0.0006|||||||ANOVA|||These results are from the 15-year analysis.||||.0006
71041124|NCT00434837|141590719|SUPERIORITY|||||||0.15|||||||ANOVA|||These results are from the 15-year analysis.||||.15
71041125|NCT00434837|141590720|SUPERIORITY|||||||0.34|||||||Chi-squared|||These results are from the 15-year analysis.||||.34
71041126|NCT00434837|141590721|SUPERIORITY|||||||0.17|||||||ANOVA|||These results are from the 15-year analysis.||||.17
71041127|NCT00434837|141590722|SUPERIORITY|||||||0.25|||||||ANOVA|||These results are from the 15-year analysis.||||.25
71041128|NCT00434837|141590723|SUPERIORITY|||||||0.61|||||||ANOVA|||These results are from the 15-year analysis.||||.61
71041129|NCT00434837|141590724|SUPERIORITY|||||||0.15|||||||ANOVA|||These results are from the 15-year analysis.||||.15
71041130|NCT00434837|141590725|SUPERIORITY|||||||0.53|||||||ANOVA|||These results are from the 15-year analysis.||||.53
71041131|NCT00434837|141590726|SUPERIORITY|||||||0.82|||||||ANOVA|||These results are from the 15-year analysis.||||.82
71041132|NCT00434837|141590727|SUPERIORITY|||||||0.03|||||||ANOVA|||These results are from the 15-year analysis.||||.03
71041133|NCT00434837|141590728|SUPERIORITY|||||||0.67|||||||ANOVA|||These results are from the 15-year analysis.||||.67
71041134|NCT00434837|141590730|SUPERIORITY|||||||0.051|||||||ANOVA|||These results are from the 15-year analysis.||||.051
71041135|NCT00434837|141590731|SUPERIORITY|||||||0.14|||||||ANOVA|||These results were from the 15-year analysis.||||.14
71041136|NCT00434837|141590732|SUPERIORITY|||||||0.067|||||||ANOVA|||These results are from the 15-year analysis.||||.067
71041137|NCT00434837|141590733|SUPERIORITY|||||||0.54|||||||ANOVA|||These results were from the 7-year analysis.||||.54
71041138|NCT00434837|141590734|SUPERIORITY|||||||0.08|||||||ANOVA|||These results are from the 15-year analysis.||||.08
71041139|NCT01881737|141590756|SUPERIORITY_OR_OTHER|||||||0.848|||||||Paired t test|||Effect Size Cohen's d = -0.05||||0.848
71041140|NCT01881737|141590757|SUPERIORITY_OR_OTHER|||||||0.009|||||||Paired t test|Effect Size Cohen's d = 0.53||||||0.009
71041141|NCT01881737|141590758|SUPERIORITY_OR_OTHER|||||||0.38|||||||paired t test|Effect size Cohen's d = 0.38||||||0.38
71100244|NCT02662582|141709120|SUPERIORITY||LSMean difference|2.1||||0.216|TWO_SIDED|90.0|-0.7|5.0||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||5.0|-0.7|0.216
70997494|NCT01861054|141502647|OTHER|||||||0.1451||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||CD11b in PMNs - IL-8||||0.1451
70997495|NCT01861054|141502647|OTHER|||||||0.2779||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||CD18 in PMNs - IL-8||||0.2779
70997496|NCT01861054|141502647|OTHER|||||||0.1444||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||MFI of CD11b - IL-8||||0.1444
70997497|NCT01861054|141502647|OTHER|||||||0.1453||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||MFI of CD66b - IL-8||||0.1453
70997498|NCT01861054|141502647|OTHER|||||||0.92||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||MFI of CD18 - IL-8||||0.9200
70997499|NCT01861054|141502647|OTHER|||||||0.2779||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||CD11b in PMNs - US||||0.2779
70997500|NCT01861054|141502647|OTHER|||||||0.6164||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||CD18 in PMNs - US||||0.6164
70997501|NCT01861054|141502647|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||MFI of CD11b - US||||>0.9999
70997502|NCT01861054|141502647|OTHER|||||||0.2032||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||MFI of CD66b - US||||0.2032
70997503|NCT01861054|141502647|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||MFI of CD18 - US||||>0.9999
70997504|NCT01861054|141502647|OTHER|||||||0.525||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL6 - IL-8||||0.5250
70997505|NCT01861054|141502647|OTHER|||||||0.6706||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL1b - IL-8||||0.6706
70997506|NCT01861054|141502647|OTHER|||||||0.8312||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL8 - IL-8||||0.8312
70997507|NCT01861054|141502647|OTHER|||||||0.3992||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing TNFa - IL-8||||0.3992
70997508|NCT01861054|141502647|OTHER|||||||0.2952||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL6 - IL-8||||0.2952
70997509|NCT01861054|141502647|OTHER|||||||0.3992||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL1b - IL-8||||0.3992
70997510|NCT01861054|141502647|OTHER|||||||0.2952||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL8 - IL-8||||0.2952
70997511|NCT01861054|141502647|OTHER|||||||0.525||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing TNFa - IL-8||||0.5250
70997512|NCT01861054|141502647|OTHER|||||||0.3992||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL6 - US||||0.3992
70997513|NCT01861054|141502647|OTHER|||||||0.2952||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL1b - US||||0.2952
70997514|NCT01861054|141502647|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL8 - US||||>0.9999
70997515|NCT01861054|141502647|OTHER|||||||0.3992||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing TNFa - US||||0.3992
70997516|NCT01861054|141502647|OTHER|||||||0.3992||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL6 - US||||0.3992
70997517|NCT01861054|141502647|OTHER|||||||0.2952||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL1b - US||||0.2952
70997518|NCT01861054|141502647|OTHER|||||||0.3992||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL8 - US||||0.3992
71041142|NCT01881737|141590760|SUPERIORITY_OR_OTHER|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
71041143|NCT00345033|141590761|NON_INFERIORITY_OR_EQUIVALENCE|A priori power calculation determined the power to detect a change in total cholesterol is over 99%.||||||0.125||95.0|||||ANCOVA|||||||0.125
71041144|NCT00345033|141590762|NON_INFERIORITY_OR_EQUIVALENCE|A priori power calculation determined the power to detect a change in weight will be over 99%.||||||0.109||95.0|||||ANCOVA|||||||0.109
71041145|NCT00345033|141590763|NON_INFERIORITY_OR_EQUIVALENCE|A priori power calculation determined the power to detect a change in Body Mass Index (BMI) will be over 99%.||||||0.229||95.0|||||ANCOVA|||||||0.229
71041146|NCT00345033|141590764|NON_INFERIORITY_OR_EQUIVALENCE|A priori power calculation determined the power to detect a change in glucose metabolism to be 90%.||||||0.01||95.0|||||ANCOVA|||||||0.010
70997519|NCT01861054|141502647|OTHER|||||||0.2952||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing TNFa - US||||0.2952
70997520|NCT01861054|141502647|OTHER|||||||0.2238||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL6 - LPS||||0.2238
70997521|NCT01861054|141502647|OTHER|||||||0.2238||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL1b - LPS||||0.2238
70997522|NCT01861054|141502647|OTHER|||||||0.1543||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL8 - LPS||||0.1543
70997523|NCT01861054|141502647|OTHER|||||||0.1547||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing TNFa - LPS||||0.1547
70997524|NCT01861054|141502647|OTHER|||||||0.1547||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL6 - LPS||||0.1547
70997525|NCT01861054|141502647|OTHER|||||||0.1547||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL1b - LPS||||0.1547
70997526|NCT01861054|141502647|OTHER|||||||0.4314||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL8 - LPS||||0.4314
70997527|NCT01861054|141502647|OTHER|||||||0.3153||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing TNFa - LPS||||0.3153
70997528|NCT01861054|141502647|OTHER|||||||0.47||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL6 - LPS+IL-8||||0.4700
70997529|NCT01861054|141502647|OTHER|||||||0.1605||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL1b - LPS+IL-8||||0.1605
71041147|NCT00345033|141590765|NON_INFERIORITY_OR_EQUIVALENCE|A priori power calculation determined the power to detect a change in triglycerides will be 81%.||||||0.982||95.0|||||ANCOVA|||||||0.982
70997530|NCT01861054|141502647|OTHER|||||||0.1605||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL8 - LPS+IL-8||||0.1605
70997531|NCT01861054|141502647|OTHER|||||||0.1605||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing TNFa - LPS+IL-8||||0.1605
70997532|NCT01861054|141502647|OTHER|||||||0.1547||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL6 - LPS+IL-8||||0.1547
70997533|NCT01861054|141502647|OTHER|||||||0.1547||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL1b - LPS+IL-8||||0.1547
70997534|NCT01861054|141502647|OTHER|||||||0.3153||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL8 - LPS+IL-8||||0.3153
70997535|NCT01861054|141502647|OTHER|||||||0.1543||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing TNFa - LPS+IL-8||||0.1543
70997536|NCT01861054|141502647|OTHER|||||||0.1601||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent FITC eColi Control||||0.1601
70997537|NCT01861054|141502647|OTHER|||||||0.2368||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent FITC eColi Test||||0.2368
70997538|NCT01861054|141502647|OTHER|||||||0.1605||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent PMNs unstimulated||||0.1605
70997539|NCT01861054|141502647|OTHER|||||||0.47||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent PMNs fMLP||||0.4700
70997540|NCT01861054|141502647|OTHER|||||||0.3392||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent L-selectin unstimulated||||0.3392
70997541|NCT01861054|141502647|OTHER|||||||0.808||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent L-selectin fMLP||||0.8080
70997542|NCT03796182|141502648|EQUIVALENCE|The corresponding 90% confidence intervals equivalence criteria was (80%, 125%) acceptance range.|Ratio|98.5|||||TWO_SIDED|90.0|82.09|118.2||||||||118.20|82.09|
70997543|NCT03796182|141502649|EQUIVALENCE|The corresponding 90% confidence intervals equivalence criteria was (80%, 125%) acceptance range.|Ratio|93.49|||||TWO_SIDED|90.0|85.15|102.65||||||||102.65|85.15|
71041148|NCT00345033|141590766|NON_INFERIORITY_OR_EQUIVALENCE|A priori power calculation determined the power to detect a change in Insulin Resistance will be 90%.||||||0.082||95.0|||||ANCOVA|||||||0.082
70997544|NCT03796182|141502650|EQUIVALENCE|The corresponding 90% confidence intervals equivalence criteria was (80%, 125%) acceptance range.|Ratio|88.07|||||TWO_SIDED|90.0|80.99|95.76||||||||95.76|80.99|
70997545|NCT03796182|141502652|EQUIVALENCE|The corresponding 90% confidence intervals equivalence criteria was (80%, 125%) acceptance range.|Ratio|94.25|||||TWO_SIDED|90.0|88.19|100.73||||||||100.73|88.19|
70997546|NCT00405821|141502662|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75|||<|0.05|TWO_SIDED|95.0|0.58|0.99||P-value was adjusted to include multiple looks at data including an interim efficacy review at 50% and 75% accrual of person-years on study|Regression, Cox|adjusted for baseline log10 viral load, baseline CD4 count, gender, and age||Intent-to-treat analysis used Cox proportional hazards (CPH) models, adjusting for baseline log10 viral load (VL), CD4 cell count, gender and age to assess the risk of disease progression||0.99|0.58|<0.05
70997547|NCT00405821|141502663|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.31|||<|0.05|TWO_SIDED|95.0|0.19|0.48||we included multiple GUD events per subject in the estimate of GUD incidence|rate ratio with 95% CI|||Null hypothesis is no difference by treatment arm in rate of GUD.||0.48|0.19|<0.05
70997548|NCT00405821|141502664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.463||||0.05|TWO_SIDED|95.0|-0.731|-0.194|||t-test, 2 sided|||Null hypothesis is no difference in annual rate of change in log10 viral load by arm.||-0.194|-0.731|0.05
70997549|NCT04962503|141502668|OTHER|||||||0.0313||||||Change from baseline to Day 3|Wilcoxon (Mann-Whitney)|||||||0.0313
70997550|NCT04962503|141502668|OTHER|||||||0.0625||||||Change from baseline to Day 9|Wilcoxon (Mann-Whitney)|||||||0.0625
71041149|NCT02102932|141590767|SUPERIORITY_OR_OTHER||Ratio of the geometric means|105.29|STANDARD_DEVIATION|6.6||0|TWO_SIDED|90.0|101.92|108.78||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||108.78|101.92|0.0000
71041150|NCT02102932|141590767|SUPERIORITY_OR_OTHER||Ratio of the geometric means|103.23|STANDARD_DEVIATION|6.6||0|TWO_SIDED|90.0|99.91|106.65||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||106.65|99.91|0.0000
71041151|NCT02102932|141590767|SUPERIORITY_OR_OTHER||Ratio of the geometric means|103.56|STANDARD_DEVIATION|7.6||0|TWO_SIDED|90.0|99.73|107.54||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||107.54|99.73|0.0000
71100245|NCT02662582|141709121|SUPERIORITY||LSMean difference|-7.4||||0.171|TWO_SIDED|90.0|-16.5|1.6||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.6|-16.5|0.171
70997551|NCT01769469|141502681|OTHER|||||||0.2085|||||||Wilcoxon (Mann-Whitney)|||Test of difference at Week 48 from baseline||||0.2085
70997552|NCT01769469|141502685|SUPERIORITY|||||||0.2452|||||||Wilcoxon Signed Rank Test|||||||0.2452
70997553|NCT01769469|141502693|SUPERIORITY|||||||0.0806|||||||Wilcoxon Signed Rank Test|||||||.0806
70997554|NCT01769469|141502704|OTHER|||||||0.6545|||||||Wilcoxon Signed Rank Test|||||||0.6545
70997555|NCT01769469|141502708|OTHER|||||||0.8739|||||||Wilcoxon Signed Rank Test|||||||0.8739
70997556|NCT01769469|141502716|OTHER|||||||0.5014|||||||Wilcoxon Signed Rank Test|||||||0.5014
70997557|NCT01769469|141502717|OTHER|||||||0.2431|||||||Wilcoxon Signed Rank Test|||||||0.2431
70997558|NCT01769469|141502718|OTHER|||||||0.7209|||||||Wilcoxon Signed Rank Test|||||||0.7209
70997559|NCT01769469|141502719|OTHER|||||||0.5379|||||||Wilcoxon Signed Rank Test|||||||0.5379
70997560|NCT01769469|141502720|OTHER|||||||0.7986|||||||Wilcoxon Signed Rank Test|||||||0.7986
70997561|NCT01769469|141502740|OTHER|||||||0.8507|||||||Wilcoxon Signed Rank Test|||||||0.8507
70997562|NCT01769469|141502741|OTHER|||||||0.3483|||||||Wilcoxon Signed Rank Test|||||||0.3483
70997563|NCT01769469|141502748|OTHER|||||||0.4043|||||||Wilcoxon (Mann-Whitney)|||||||0.4043
70997564|NCT01769469|141502749|OTHER|||||||0.2927|||||||Wilcoxon (Mann-Whitney)|||||||0.2927
70997565|NCT01769469|141502750|OTHER|||||||0.1134|||||||Wilcoxon (Mann-Whitney)|||||||0.1134
70997566|NCT01769469|141502751|OTHER|||||||0.5782|||||||Wilcoxon (Mann-Whitney)|||||||0.5782
70997567|NCT01769469|141502752|OTHER|||||||0.8658|||||||Wilcoxon (Mann-Whitney)|||||||0.8658
70997568|NCT01769469|141502753|OTHER|||||||0.5491|||||||Wilcoxon (Mann-Whitney)|||||||0.5491
70997569|NCT01769469|141502754|OTHER|||||||0.0238|||||||Wilcoxon (Mann-Whitney)|||||||0.0238
70997570|NCT01769469|141502755|OTHER|||||||0.1172|||||||Wilcoxon (Mann-Whitney)|||||||0.1172
70997571|NCT01769469|141502756|OTHER|||||||0.122|||||||Wilcoxon (Mann-Whitney)|||||||0.1220
70997572|NCT01769469|141502757|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
70997573|NCT01769469|141502759|OTHER|||||||0.7785|||||||Wilcoxon (Mann-Whitney)|||||||0.7785
70997574|NCT01769469|141502760|OTHER|||||||0.4933|||||||Wilcoxon (Mann-Whitney)|||||||0.4933
70997575|NCT01769469|141502761|OTHER|||||||0.5491|||||||Wilcoxon (Mann-Whitney)|||||||0.5491
70997576|NCT01769469|141502762|OTHER|||||||0.5161|||||||Wilcoxon (Mann-Whitney)|||||||0.5161
70997577|NCT01769469|141502763|OTHER|||||||0.599|||||||Wilcoxon (Mann-Whitney)|||||||0.5990
70997578|NCT01769469|141502764|OTHER|||||||0.8579|||||||Wilcoxon (Mann-Whitney)|||||||0.8579
71041152|NCT02102932|141590767|SUPERIORITY_OR_OTHER||Ratio of the geometric means|102.81|STANDARD_DEVIATION|6.9||0|TWO_SIDED|90.0|99.36|106.37||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||106.37|99.36|0.0000
70997579|NCT01769469|141502765|OTHER|||||||0.0719|||||||Wilcoxon (Mann-Whitney)|||||||0.0719
70997580|NCT01769469|141502766|OTHER|||||||0.3148|||||||Wilcoxon (Mann-Whitney)|||||||0.3148
70997581|NCT01769469|141502767|OTHER|||||||0.139|||||||Wilcoxon (Mann-Whitney)|||||||0.1390
70997582|NCT01769469|141502768|OTHER|||||||0.2726|||||||Wilcoxon (Mann-Whitney)|||||||0.2726
70997583|NCT01769469|141502769|OTHER|||||||0.537|||||||Wilcoxon (Mann-Whitney)|||||||0.5370
70997584|NCT01769469|141502770|OTHER|||||||0.2926|||||||Wilcoxon (Mann-Whitney)|||||||0.2926
70997585|NCT01769469|141502771|OTHER|||||||0.1906|||||||Wilcoxon (Mann-Whitney)|||||||0.1906
70997586|NCT01769469|141502772|OTHER|||||||0.2255|||||||Wilcoxon (Mann-Whitney)|||||||0.2255
70997587|NCT01769469|141502773|OTHER|||||||0.6285|||||||Wilcoxon (Mann-Whitney)|||||||0.6285
70997588|NCT01769469|141502774|OTHER|||||||0.0148|||||||Wilcoxon (Mann-Whitney)|||||||0.0148
70997589|NCT01769469|141502775|OTHER|||||||0.0166|||||||Wilcoxon (Mann-Whitney)|||||||0.0166
70997590|NCT01769469|141502776|OTHER|||||||0.0277|||||||Wilcoxon (Mann-Whitney)|||||||0.0277
71100246|NCT02662582|141709121|SUPERIORITY||LSMean difference|0.2||||0.976|TWO_SIDED|90.0|-10.3|10.7||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||10.7|-10.3|0.976
70997591|NCT01769469|141502777|OTHER|||||||0.261|||||||Wilcoxon (Mann-Whitney)|||||||0.2610
70997592|NCT01769469|141502778|OTHER|||||||0.4154|||||||Wilcoxon (Mann-Whitney)|||||||0.4154
70997593|NCT01769469|141502779|OTHER|||||||0.7125|||||||Wilcoxon (Mann-Whitney)|||||||0.7125
70997594|NCT01617187|141502827|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) means difference|-1.3|STANDARD_ERROR_OF_MEAN|2.46||0.6043|TWO_SIDED|95.0|-6.1|3.6||Adjusted p-value from graphical approach to control Type 1 error rate among primary and secondary efficacy hypotheses|Mixed Model Repeated Measures (MMRM)||Asenapine 2.5 mg BID minus Placebo BID|||3.6|-6.1|0.6043
70997595|NCT01617187|141502827|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-5.5|STANDARD_ERROR_OF_MEAN|2.32||0.0356|TWO_SIDED|95.0|-10.1|-1.0||Adjusted p-value from graphical approach to control Type 1 error rate among primary and secondary efficacy hypotheses|MMRM||Asenapine 5 mg BID minus Placebo BID|||-1.0|-10.1|0.0356
70997596|NCT01617187|141502827|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-5.4|STANDARD_ERROR_OF_MEAN|2.86||0.0587|TWO_SIDED|95.0|-11.1|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|||0.2|-11.1|0.0587
70997597|NCT01617187|141502828|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.15||0.9083|TWO_SIDED|95.0|-0.3|0.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Confirmative testing of asenapine versus placebo for this measure was to be performed only if both asenapine doses were statistically superior to placebo in reduction from baseline in PANSS Total Score (Primary outcome measure)||0.3|-0.3|0.9083
70997598|NCT01617187|141502828|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0601|TWO_SIDED|95.0|-0.6|0.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Confirmative testing of asenapine versus placebo for this measure was to be performed only if both asenapine doses were statistically superior to placebo in reduction from baseline in PANSS Total Score (Primary outcome measure)||0.0|-0.6|0.0601
70997599|NCT01617187|141502828|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.3898|TWO_SIDED|95.0|-0.5|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|||0.2|-0.5|0.3898
70997600|NCT01617187|141502829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37||||||P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Confirmative testing of asenapine versus placebo for this measure was to be performed only if both asenapine doses were statistically superior to placebo in reduction from baseline in PANSS Total Score (Primary outcome measure)||||0.3700
70997601|NCT01617187|141502829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1708||||||P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Confirmative testing of asenapine versus placebo for this measure was to be performed only if both asenapine doses were statistically superior to placebo in reduction from baseline in PANSS Total Score (Primary outcome measure)||||0.1708
70997602|NCT01617187|141502829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.262||||||P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||||||0.2620
70997603|NCT01617187|141502830|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|0.6||0.0491|TWO_SIDED|95.0|-2.4|0.0||p-value adjusted for multiple comparisons using Hochberg's method|MMRM||Asenapine 2.5 mg BID minus Olanzapine 15 mg QD|||-0.0|-2.4|0.0491
70997604|NCT01617187|141502830|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|0.57||0.0491|TWO_SIDED|95.0|-2.3|0.0||p-value adjusted for multiple comparisons using Hochberg's method|MMRM||Asenapine 5 mg BID minus Olanzapine 15 mg QD|||-0.0|-2.3|0.0491
70997605|NCT01617187|141502830|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|1.0|STANDARD_ERROR_OF_MEAN|0.51||0.0567|TWO_SIDED|95.0|0.0|2.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|||2.0|-0.0|0.0567
70997606|NCT01617187|141502830|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|1.0|STANDARD_ERROR_OF_MEAN|0.48||0.0391|TWO_SIDED|95.0|0.0|1.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|||1.9|0.0|0.0391
70997607|NCT01617187|141502830|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|2.2|STANDARD_ERROR_OF_MEAN|0.58||0.0003|TWO_SIDED|95.0|1.0|3.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|||3.3|1.0|0.0003
70997608|NCT01617187|141502831|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.8|STANDARD_ERROR_OF_MEAN|1.09||0.4849|TWO_SIDED|95.0|-1.4|2.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||2.9|-1.4|0.4849
70923803|NCT02379156|141339398|SUPERIORITY|||||||0.149|||||||t-test, 2 sided|||"Within-group differences in the percent change in total WAIS IV scores from BL to after cold ambient exposure were analyzed using a paired samples t-test. We hypothesized that participants with tetraplegia in the No Drug condition would have a greater percent change in total WAIS IV scores than the same participants in the With drug condition."||||0.149
70997609|NCT01617187|141502831|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|1.06||0.8902|TWO_SIDED|95.0|-2.2|1.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||1.9|-2.2|0.8902
70997610|NCT01617187|141502831|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|1.36||0.5826|TWO_SIDED|95.0|-3.4|1.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||1.9|-3.4|0.5826
70997611|NCT01617187|141502831|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|1.61||0.9271|TWO_SIDED|95.0|-3.3|3.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||3.0|-3.3|0.9271
70997612|NCT01617187|141502831|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.0|STANDARD_ERROR_OF_MEAN|1.56||0.1902|TWO_SIDED|95.0|-5.1|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||1.0|-5.1|0.1902
70997613|NCT01617187|141502831|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.2|STANDARD_ERROR_OF_MEAN|2.0||0.271|TWO_SIDED|95.0|-6.2|1.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||1.7|-6.2|0.2710
70997614|NCT01617187|141502831|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.7|STANDARD_ERROR_OF_MEAN|1.79||0.6773|TWO_SIDED|95.0|-2.8|4.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||4.3|-2.8|0.6773
70997615|NCT01617187|141502831|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.8|STANDARD_ERROR_OF_MEAN|1.72||0.2895|TWO_SIDED|95.0|-5.2|1.6||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||1.6|-5.2|0.2895
71041153|NCT02102932|141590768|SUPERIORITY_OR_OTHER||Ratio of the geometric means|104.56|STANDARD_DEVIATION|14.0||0.0001|TWO_SIDED|90.0|97.56|112.07||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||112.07|97.56|0.0001
70997616|NCT01617187|141502831|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.7|STANDARD_ERROR_OF_MEAN|2.18||0.4261|TWO_SIDED|95.0|-6.0|2.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||2.6|-6.0|0.4261
70997617|NCT01617187|141502831|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|1.3|STANDARD_ERROR_OF_MEAN|2.13||0.5505|TWO_SIDED|95.0|-2.9|5.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||5.5|-2.9|0.5505
70997618|NCT01617187|141502831|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.6|STANDARD_ERROR_OF_MEAN|2.03||0.4286|TWO_SIDED|95.0|-5.6|2.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||2.4|-5.6|0.4286
70997619|NCT01617187|141502831|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.0|STANDARD_ERROR_OF_MEAN|2.56||0.4423|TWO_SIDED|95.0|-7.0|3.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||3.1|-7.0|0.4423
70997620|NCT01617187|141502831|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|3.2|STANDARD_ERROR_OF_MEAN|2.3||0.1691|TWO_SIDED|95.0|-1.4|7.7||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||7.7|-1.4|0.1691
70997621|NCT01617187|141502831|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.6|STANDARD_ERROR_OF_MEAN|2.17||0.4682|TWO_SIDED|95.0|-5.8|2.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||2.7|-5.8|0.4682
70997622|NCT01617187|141502831|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.8|STANDARD_ERROR_OF_MEAN|2.71||0.4961|TWO_SIDED|95.0|-7.2|3.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||3.5|-7.2|0.4961
70997623|NCT01617187|141502831|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.6|STANDARD_ERROR_OF_MEAN|2.26||0.4697|TWO_SIDED|95.0|-6.1|2.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||2.8|-6.1|0.4697
70997624|NCT01617187|141502831|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.6|STANDARD_ERROR_OF_MEAN|2.14||0.0947|TWO_SIDED|95.0|-7.8|0.6||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.6|-7.8|0.0947
70997625|NCT01617187|141502831|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-4.9|STANDARD_ERROR_OF_MEAN|2.68||0.0675|TWO_SIDED|95.0|-10.2|0.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.4|-10.2|0.0675
70997626|NCT01617187|141502832|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1736||||||P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4||||0.1736
70997627|NCT01617187|141502832|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1736||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4||||0.1736
70997628|NCT01617187|141502832|SUPERIORITY_OR_OTHER_LEGACY|||||||0.285||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4||||0.2850
70997629|NCT01617187|141502832|SUPERIORITY_OR_OTHER_LEGACY|||||||0.329||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7||||0.3290
70997630|NCT01617187|141502832|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6938||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7||||0.6938
70997631|NCT01617187|141502832|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1105||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7||||0.1105
70997632|NCT01617187|141502832|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6804||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14||||0.6804
70997633|NCT01617187|141502832|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9704||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14||||0.9704
70997634|NCT01617187|141502832|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6604||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14||||0.6604
71041154|NCT02102932|141590768|SUPERIORITY_OR_OTHER||Ratio of the geometric means|105.8|STANDARD_DEVIATION|12.8||0.0001|TWO_SIDED|90.0|99.32|112.7||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||112.70|99.32|0.0001
70923804|NCT02379156|141339399|SUPERIORITY||||||<|0.001|||||||ANOVA|||Between-group differences in the change in distal skin temperature temperature (Tsk) from baseline (BL) values to after ambient cold exposure (Cold) were analyzed using a mixed-model ANOVA for the AB vs Tetra comparison. We hypothesized that participants with tetraplegia would have a smaller change in Tsk due to being in a constant state of vasodilation.||||<0.001
70997635|NCT01617187|141502832|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2447||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21||||0.2447
70997636|NCT01617187|141502832|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4834||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21||||0.4834
70997637|NCT01617187|141502832|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9189||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21||||0.9189
71041155|NCT02102932|141590768|SUPERIORITY_OR_OTHER||Ratio of the geometric means|103.75|STANDARD_DEVIATION|11.2||0|TWO_SIDED|90.0|98.18|109.63||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||109.63|98.18|0.0000
71041156|NCT02102932|141590768|SUPERIORITY_OR_OTHER||Ratio of the geometric means|95.77|STANDARD_DEVIATION|12.8||0|TWO_SIDED|90.0|89.88|102.03||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||102.03|89.88|0.0000
70997638|NCT01617187|141502832|SUPERIORITY_OR_OTHER_LEGACY|||||||0.437||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28||||0.4370
71041157|NCT02102932|141590769|SUPERIORITY_OR_OTHER||Ratio of the geometric means|106.44|STANDARD_DEVIATION|11.8||0|TWO_SIDED|90.0|100.44|112.8||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||112.80|100.44|0.0000
71041158|NCT02102932|141590769|SUPERIORITY_OR_OTHER||Ratio of the geometric means|110.78|STANDARD_DEVIATION|13.2||0.0021|TWO_SIDED|90.0|103.8|118.24||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||118.24|103.80|0.0021
70997639|NCT01617187|141502832|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2894||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28||||0.2894
70997640|NCT01617187|141502832|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6953||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28||||0.6953
70997641|NCT01617187|141502832|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4892||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35||||0.4892
70997642|NCT01617187|141502832|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1954||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35||||0.1954
70997643|NCT01617187|141502832|SUPERIORITY_OR_OTHER_LEGACY|||||||0.799||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35||||0.7990
70997644|NCT01617187|141502833|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.4255|TWO_SIDED|95.0|-0.1|0.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||0.2|-0.1|0.4255
70997645|NCT01617187|141502833|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.9564|TWO_SIDED|95.0|-0.1|0.1||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||0.1|-0.1|0.9564
70997646|NCT01617187|141502833|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.6363|TWO_SIDED|95.0|-0.2|0.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.1|-0.2|0.6363
70997647|NCT01617187|141502833|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8759|TWO_SIDED|95.0|-0.2|0.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||0.2|-0.2|0.8759
70997648|NCT01617187|141502833|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.9598|TWO_SIDED|95.0|-0.2|0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.2|-0.2|0.9598
70997649|NCT01617187|141502833|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.9789|TWO_SIDED|95.0|-0.2|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.2|-0.2|0.9789
70997650|NCT01617187|141502833|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.4671|TWO_SIDED|95.0|-0.3|0.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||0.1|-0.3|0.4671
70997651|NCT01617187|141502833|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.6359|TWO_SIDED|95.0|-0.3|0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.2|-0.3|0.6359
70997652|NCT01617187|141502833|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.5454|TWO_SIDED|95.0|-0.4|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||0.2|-0.4|0.5454
70997653|NCT01617187|141502833|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.4188|TWO_SIDED|95.0|-0.2|0.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||0.4|-0.2|0.4188
70997654|NCT01617187|141502833|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.5318|TWO_SIDED|95.0|-0.3|0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.2|-0.3|0.5318
70997655|NCT01617187|141502833|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.16||0.5683|TWO_SIDED|95.0|-0.4|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||0.2|-0.4|0.5683
70997656|NCT01617187|141502833|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.14||0.2972|TWO_SIDED|95.0|-0.1|0.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||0.4|-0.1|0.2972
70997657|NCT01617187|141502833|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.482|TWO_SIDED|95.0|-0.4|0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||0.2|-0.4|0.4820
70997658|NCT01617187|141502833|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.9901|TWO_SIDED|95.0|-0.3|0.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||0.3|-0.3|0.9901
70997659|NCT01617187|141502833|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.6682|TWO_SIDED|95.0|-0.4|0.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||0.2|-0.4|0.6682
70997660|NCT01617187|141502833|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1111|TWO_SIDED|95.0|-0.5|0.1||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.1|-0.5|0.1111
70997661|NCT01617187|141502833|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.24|TWO_SIDED|95.0|-0.5|0.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.1|-0.5|0.2400
70997662|NCT01617187|141502834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6205||||||P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4||||0.6205
70997663|NCT01617187|141502834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4829||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4||||0.4829
70997664|NCT01617187|141502834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3945||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4||||0.3945
70997665|NCT01617187|141502834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4076||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7||||0.4076
70997666|NCT01617187|141502834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.969||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7||||0.9690
70997667|NCT01617187|141502834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.117||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7||||0.1170
70997668|NCT01617187|141502834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5088||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14||||0.5088
70997669|NCT01617187|141502834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3426||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14||||0.3426
70997670|NCT01617187|141502834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0762||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14||||0.0762
70997671|NCT01617187|141502834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5531||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21||||0.5531
70997672|NCT01617187|141502834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4875||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21||||0.4875
70997673|NCT01617187|141502834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0692||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21||||0.0692
70997674|NCT01617187|141502834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7482||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28||||0.7482
70997675|NCT01617187|141502834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8037||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28||||0.8037
70923805|NCT02379156|141339399|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within-group differences in the change in distal skin temperature temperature (Tsk) from baseline (BL) values to after ambient cold exposure (Cold) were analyzed using a repeated measures ANOVA for the within-group comparison of drug vs no drug in the tetraplegia group. We hypothesized that participants with tetraplegia with drug would have a larger decrease in Tsk due to enhanced peripheral vasoconstriction due to the drug's effects.||||<.001
70923806|NCT02379156|141339400|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Between-group differences in the percent change in microvascular perfusion from baseline to after cool ambient exposure were analyzed using independent samples T-test. We hypothesized that participants with tetraplegia would have a smaller percent change in microvascular perfusion due impaired vasomotor control which causes a constant state of vasodilation.||||<0.001
70923807|NCT02379156|141339400|SUPERIORITY|||||||0.066|||||||t-test, 2 sided|||"Within-group differences in the percent change in microvascular perfusion from baseline to after cool ambient exposure were analyzed using a paired samples t-test. We hypothesized that participants with tetraplegia in the No Drug condition would have a smaller percent change in microvascular perfusion due impaired vasomotor control which causes a constant state of vasodilation."||||0.066
70923808|NCT02379156|141339401|SUPERIORITY|||||||0.127|||||||t-test, 2 sided|||Between-group differences in the percent change in VO2 from baseline to after cool ambient exposure were analyzed using independent samples t-test. We hypothesized that participants with tetraplegia would have a smaller percent change in VO2 consumption.||||0.127
70923809|NCT02379156|141339401|SUPERIORITY|||||||0.964|||||||t-test, 2 sided|||"Within-group differences in the percent change in VO2 consumption from baseline to after cool ambient exposure were analyzed using a paired samples t-test. We hypothesized that participants with tetraplegia in the No Drug condition would have a greater percent change in VO2 consumption due to impaired vasoconstriction and greater heat loss compared to the With Drug condition, in response to cool ambient exposure."||||0.964
70923810|NCT03328702|141339422|SUPERIORITY|Repeated measures ANOVA|Mean Difference (Net)|0.01|||<|0.05|TWO_SIDED|||||Repeated measures ANOVA, N=4|ANOVA|Repeated measures ANOVA||The null hypothesis is that there is no difference in total pharyngeal transit time with the use of CPAP||||<0.05
70923811|NCT04833777|141339423|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70923812|NCT04833777|141339424|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70923813|NCT04833777|141339425|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70923814|NCT04833777|141339426|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70923815|NCT04833777|141339427|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70923816|NCT04833777|141339428|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70923817|NCT04833777|141339429|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70923818|NCT04833777|141339430|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70923819|NCT04833777|141339431|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
70923820|NCT04833777|141339432|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
70923821|NCT04833777|141339433|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
70923822|NCT04833777|141339434|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
70923823|NCT04833777|141339435|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
70923824|NCT04833777|141339436|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
70923825|NCT04833777|141339438|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
70923826|NCT04833777|141339439|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
70923827|NCT04172441|141339476|SUPERIORITY||Difference in LS means|-5.21||||0.0037|TWO_SIDED|95.0|-8.29|-2.13|||Mixed Models Analysis|A mixed model was used, with treatment and period as fixed effects and patient as random effect.|The comparison was in the direction of dasiglucagon minus placebo.|Null hypothesis: weighted mean IV GIR in the last 12 hours of treatment with dasiglucagon = weighted mean IV GIR in the last 12 hours of treatment with placebo||-2.13|-8.29|0.0037
70923828|NCT04172441|141339477|SUPERIORITY||Difference in LS means|-30.93||||0.0238|TWO_SIDED|95.0|-56.8|-5.05|||Mixed Models Analysis|A mixed model was used, with treatment and period as fixed effects and patient as random effect.|The comparison was in the direction of dasiglucagon minus placebo.|Null hypothesis: Total amount of carbohydrates administered (regardless of route) per day in patients treated with dasiglucagon = total amount of carbohydrates administered (regardless of route) per day in patients treated with placebo||-5.05|-56.80|0.0238
70923829|NCT04674358|141339501|SUPERIORITY||Odds Ratio (OR)|2.63|||||TWO_SIDED|95.0|1.67|4.14||||||||4.14|1.67|
70923830|NCT03648840|141339502|OTHER||||||<|0.2|||||||t-test, 2 sided|||2-tailed, unpaired T-test||||<0.2
70923831|NCT03703700|141339510|OTHER||Risk Ratio (RR)|1.23||||0.042|TWO_SIDED|95.0|1.01|1.5|||Chi-squared|||||1.50|1.01|0.042
70923832|NCT03703700|141339511|OTHER|||||||0.781|||||||Wilcoxon (Mann-Whitney)|||||||0.781
70923833|NCT03703700|141339512|OTHER|||||||0.609|||||||Wilcoxon (Mann-Whitney)|||||||0.609
70923834|NCT03703700|141339513|OTHER|||||||0.528|||||||Wilcoxon (Mann-Whitney)|||||||0.528
70997676|NCT01617187|141502834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0859||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28||||0.0859
70997677|NCT01617187|141502834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.585||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35||||0.5850
71100247|NCT02662582|141709122|SUPERIORITY||LSMean difference|-0.6||||0.844|TWO_SIDED|90.0|-6.1|4.9||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||4.9|-6.1|0.844
70997678|NCT01617187|141502834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9698||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35||||0.9698
70997679|NCT01617187|141502834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0132||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35||||0.0132
70997680|NCT01617187|141502834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7129||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 42||||0.7129
70997681|NCT01617187|141502834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5074||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 42||||0.5074
70997682|NCT01617187|141502834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 42||||0.0040
70997683|NCT01617187|141502835|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.4||0.8829|TWO_SIDED|95.0|-0.7|0.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||0.8|-0.7|0.8829
70997684|NCT01617187|141502835|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.39||0.5488|TWO_SIDED|95.0|-0.5|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||1.0|-0.5|0.5488
70997685|NCT01617187|141502835|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.783|TWO_SIDED|95.0|-1.1|0.8||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.8|-1.1|0.7830
70997686|NCT01617187|141502835|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.45||0.807|TWO_SIDED|95.0|-1.0|0.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||0.8|-1.0|0.8070
70997687|NCT01617187|141502835|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.44||0.528|TWO_SIDED|95.0|-1.1|0.6||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.6|-1.1|0.5280
70997688|NCT01617187|141502835|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.57||0.4025|TWO_SIDED|95.0|-1.6|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.6|-1.6|0.4025
70997689|NCT01617187|141502835|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.51||0.6471|TWO_SIDED|95.0|-0.8|1.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||1.2|-0.8|0.6471
70997690|NCT01617187|141502835|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.49||0.2504|TWO_SIDED|95.0|-1.5|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.4|-1.5|0.2504
70923835|NCT03703700|141339514|OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.880
70923836|NCT03703700|141339515|OTHER|||||||0.289|||||||Wilcoxon (Mann-Whitney)|||||||0.289
70997691|NCT01617187|141502835|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.62||0.9223|TWO_SIDED|95.0|-1.2|1.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||1.3|-1.2|0.9223
70997692|NCT01617187|141502835|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.56||0.8839|TWO_SIDED|95.0|-1.0|1.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||1.2|-1.0|0.8839
70997693|NCT01617187|141502835|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.54||0.8077|TWO_SIDED|95.0|-1.2|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.9|-1.2|0.8077
70997694|NCT01617187|141502835|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.68||0.6216|TWO_SIDED|95.0|-1.0|1.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||1.7|-1.0|0.6216
70997695|NCT01617187|141502835|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.5|STANDARD_ERROR_OF_MEAN|0.61||0.4248|TWO_SIDED|95.0|-0.7|1.7||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||1.7|-0.7|0.4248
70997696|NCT01617187|141502835|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.58||0.7667|TWO_SIDED|95.0|-1.3|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||1.0|-1.3|0.7667
70997697|NCT01617187|141502835|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.4|STANDARD_ERROR_OF_MEAN|0.72||0.6282|TWO_SIDED|95.0|-1.1|1.8||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||1.8|-1.1|0.6282
70997698|NCT01617187|141502835|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.65||0.315|TWO_SIDED|95.0|-1.9|0.6||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||0.6|-1.9|0.3150
70997699|NCT01617187|141502835|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.61||0.1908|TWO_SIDED|95.0|-2.0|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.4|-2.0|0.1908
70997700|NCT01617187|141502835|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.77||0.3128|TWO_SIDED|95.0|-2.3|0.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.7|-2.3|0.3128
70997701|NCT01617187|141502835|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.73||0.8812|TWO_SIDED|95.0|-1.5|1.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||1.3|-1.5|0.8812
70997702|NCT01617187|141502835|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.69||0.1143|TWO_SIDED|95.0|-2.4|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||0.3|-2.4|0.1143
70997703|NCT01617187|141502835|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.84||0.4418|TWO_SIDED|95.0|-2.3|1.0||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||1.0|-2.3|0.4418
70997704|NCT01617187|141502836|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.5|STANDARD_ERROR_OF_MEAN|0.4||0.216|TWO_SIDED|95.0|-0.3|1.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||1.3|-0.3|0.2160
70997705|NCT01617187|141502836|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.39||0.9494|TWO_SIDED|95.0|-0.7|0.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||0.8|-0.7|0.9494
70997706|NCT01617187|141502836|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.5||0.1834|TWO_SIDED|95.0|-1.6|0.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.3|-1.6|0.1834
70997707|NCT01617187|141502836|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.53||0.6347|TWO_SIDED|95.0|-0.8|1.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||1.3|-0.8|0.6347
70997708|NCT01617187|141502836|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.51||0.6917|TWO_SIDED|95.0|-1.2|0.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.8|-1.2|0.6917
70997709|NCT01617187|141502836|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.0|STANDARD_ERROR_OF_MEAN|0.66||0.1431|TWO_SIDED|95.0|-2.3|0.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.3|-2.3|0.1431
70997710|NCT01617187|141502836|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.61||0.6267|TWO_SIDED|95.0|-0.9|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||1.5|-0.9|0.6267
70997711|NCT01617187|141502836|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.58||0.726|TWO_SIDED|95.0|-1.3|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.9|-1.3|0.7260
70997712|NCT01617187|141502836|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.74||0.3326|TWO_SIDED|95.0|-2.2|0.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||0.7|-2.2|0.3326
71041159|NCT02102932|141590769|SUPERIORITY_OR_OTHER||Ratio of the geometric means|101.38|STANDARD_DEVIATION|13.6||0|TWO_SIDED|90.0|94.82|108.39||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||108.39|94.82|0.0000
70997713|NCT01617187|141502836|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.5|STANDARD_ERROR_OF_MEAN|0.72||0.4575|TWO_SIDED|95.0|-0.9|1.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||1.9|-0.9|0.4575
70997714|NCT01617187|141502836|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.68||0.493|TWO_SIDED|95.0|-1.8|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.9|-1.8|0.4930
71100248|NCT02662582|141709122|SUPERIORITY||LSMean difference|-0.9||||0.751|TWO_SIDED|90.0|-5.8|4.0||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||4.0|-5.8|0.751
70923837|NCT03703700|141339516|OTHER|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||||||0.860
70997715|NCT01617187|141502836|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.86||0.1886|TWO_SIDED|95.0|-2.8|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||0.6|-2.8|0.1886
70997716|NCT01617187|141502836|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.9|STANDARD_ERROR_OF_MEAN|0.8||0.2643|TWO_SIDED|95.0|-0.7|2.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||2.5|-0.7|0.2643
70997717|NCT01617187|141502836|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.76||0.3516|TWO_SIDED|95.0|-2.2|0.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||0.8|-2.2|0.3516
70997718|NCT01617187|141502836|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|0.94||0.2068|TWO_SIDED|95.0|-3.1|0.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||0.7|-3.1|0.2068
70997719|NCT01617187|141502836|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.82||0.7284|TWO_SIDED|95.0|-1.3|1.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||1.9|-1.3|0.7284
70997720|NCT01617187|141502836|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.77||0.2698|TWO_SIDED|95.0|-2.4|0.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.7|-2.4|0.2698
70997721|NCT01617187|141502836|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.4|STANDARD_ERROR_OF_MEAN|0.96||0.151|TWO_SIDED|95.0|-3.3|0.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.5|-3.3|0.1510
70997722|NCT01617187|141502836|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.88||0.8039|TWO_SIDED|95.0|-2.0|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||1.5|-2.0|0.8039
70997723|NCT01617187|141502836|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.8|STANDARD_ERROR_OF_MEAN|0.83||0.0306|TWO_SIDED|95.0|-3.5|-0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||-0.2|-3.5|0.0306
70997724|NCT01617187|141502836|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.1|STANDARD_ERROR_OF_MEAN|1.03||0.0406|TWO_SIDED|95.0|-4.1|-0.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||-0.1|-4.1|0.0406
70997725|NCT01617187|141502837|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.66||0.7819|TWO_SIDED|95.0|-1.1|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||1.5|-1.1|0.7819
70997726|NCT01617187|141502837|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.65||0.703|TWO_SIDED|95.0|-1.5|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||1.0|-1.5|0.7030
70997727|NCT01617187|141502837|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.83||0.952|TWO_SIDED|95.0|-1.7|1.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||1.6|-1.7|0.9520
70997728|NCT01617187|141502837|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.95||0.7907|TWO_SIDED|95.0|-2.1|1.6||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||1.6|-2.1|0.7907
70997729|NCT01617187|141502837|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.4|STANDARD_ERROR_OF_MEAN|0.91||0.1391|TWO_SIDED|95.0|-3.1|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.4|-3.1|0.1391
70997730|NCT01617187|141502837|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|1.18||0.4901|TWO_SIDED|95.0|-3.1|1.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||1.5|-3.1|0.4901
70997731|NCT01617187|141502837|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|1.0||0.8079|TWO_SIDED|95.0|-1.7|2.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||2.2|-1.7|0.8079
70997732|NCT01617187|141502837|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.95||0.3889|TWO_SIDED|95.0|-2.7|1.1||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||1.1|-2.7|0.3889
71041160|NCT02102932|141590769|SUPERIORITY_OR_OTHER||Ratio of the geometric means|103.02|STANDARD_DEVIATION|16.3||0.0002|TWO_SIDED|90.0|95.08|111.63||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||111.63|95.08|0.0002
71041161|NCT02102932|141590770|SUPERIORITY_OR_OTHER||Ratio of the geometric means|104.91|STANDARD_DEVIATION|11.2||0|TWO_SIDED|90.0|99.29|110.86||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||110.86|99.29|0.0000
71041162|NCT02102932|141590770|SUPERIORITY_OR_OTHER||Ratio of the geometric means|106.32|STANDARD_DEVIATION|15.7||0.0008|TWO_SIDED|90.0|98.39|114.88||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||114.88|98.39|0.0008
70997733|NCT01617187|141502837|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.0|STANDARD_ERROR_OF_MEAN|1.21||0.3907|TWO_SIDED|95.0|-3.4|1.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||1.3|-3.4|0.3907
70997734|NCT01617187|141502837|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.7|STANDARD_ERROR_OF_MEAN|1.15||0.5363|TWO_SIDED|95.0|-1.5|3.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||3.0|-1.5|0.5363
70997735|NCT01617187|141502837|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|1.09||0.5075|TWO_SIDED|95.0|-2.9|1.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||1.4|-2.9|0.5075
70997736|NCT01617187|141502837|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.0|STANDARD_ERROR_OF_MEAN|1.38||0.4526|TWO_SIDED|95.0|-3.7|1.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||1.7|-3.7|0.4526
70997737|NCT01617187|141502837|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|1.8|STANDARD_ERROR_OF_MEAN|1.26||0.1548|TWO_SIDED|95.0|-0.7|4.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||4.3|-0.7|0.1548
70997738|NCT01617187|141502837|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|1.19||0.6589|TWO_SIDED|95.0|-2.9|1.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||1.8|-2.9|0.6589
70997739|NCT01617187|141502837|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.0|STANDARD_ERROR_OF_MEAN|1.48||0.5171|TWO_SIDED|95.0|-3.9|2.0||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||2.0|-3.9|0.5171
70997740|NCT01617187|141502837|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|1.2||0.3133|TWO_SIDED|95.0|-3.6|1.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||1.2|-3.6|0.3133
70997741|NCT01617187|141502837|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.6|STANDARD_ERROR_OF_MEAN|1.13||0.1723|TWO_SIDED|95.0|-3.8|0.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.7|-3.8|0.1723
70997742|NCT01617187|141502837|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.6|STANDARD_ERROR_OF_MEAN|1.42||0.0663|TWO_SIDED|95.0|-5.4|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.2|-5.4|0.0663
70997743|NCT01617187|141502837|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|1.32||0.5128|TWO_SIDED|95.0|-3.5|1.7||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||1.7|-3.5|0.5128
70997744|NCT01617187|141502837|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.2|STANDARD_ERROR_OF_MEAN|1.24||0.0842|TWO_SIDED|95.0|-4.6|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||0.3|-4.6|0.0842
70997745|NCT01617187|141502837|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.4|STANDARD_ERROR_OF_MEAN|1.52||0.1217|TWO_SIDED|95.0|-5.4|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||0.6|-5.4|0.1217
70997746|NCT01617187|141502838|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.7|STANDARD_ERROR_OF_MEAN|0.39||0.0584|TWO_SIDED|95.0|0.0|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||1.5|-0.0|0.0584
70997747|NCT01617187|141502838|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.38||0.5197|TWO_SIDED|95.0|-0.5|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||1.0|-0.5|0.5197
70997748|NCT01617187|141502838|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.49||0.9693|TWO_SIDED|95.0|-0.9|1.0||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||1.0|-0.9|0.9693
70997749|NCT01617187|141502838|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.56||0.6161|TWO_SIDED|95.0|-0.8|1.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||1.4|-0.8|0.6161
70997750|NCT01617187|141502838|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.54||0.788|TWO_SIDED|95.0|-1.2|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.9|-1.2|0.7880
70997751|NCT01617187|141502838|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.7||0.5526|TWO_SIDED|95.0|-1.8|1.0||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||1.0|-1.8|0.5526
70997752|NCT01617187|141502838|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.67||0.7647|TWO_SIDED|95.0|-1.1|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||1.5|-1.1|0.7647
70997753|NCT01617187|141502838|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.64||0.89|TWO_SIDED|95.0|-1.2|1.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||1.3|-1.2|0.8900
71041163|NCT02102932|141590770|SUPERIORITY_OR_OTHER||Ratio of the geometric means|104.44|STANDARD_DEVIATION|15.7||0.0003|TWO_SIDED|90.0|96.68|112.82||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||112.82|96.68|0.0003
71041164|NCT02102932|141590770|SUPERIORITY_OR_OTHER||Ratio of the geometric means|96.61|STANDARD_DEVIATION|16.9||0.0004|TWO_SIDED|90.0|88.9|104.99||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||104.99|88.90|0.0004
70997754|NCT01617187|141502838|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.81||0.7097|TWO_SIDED|95.0|-1.9|1.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||1.3|-1.9|0.7097
70997755|NCT01617187|141502838|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.6|STANDARD_ERROR_OF_MEAN|0.76||0.4601|TWO_SIDED|95.0|-0.9|2.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||2.1|-0.9|0.4601
70997756|NCT01617187|141502838|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.72||0.6288|TWO_SIDED|95.0|-1.8|1.1||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||1.1|-1.8|0.6288
70997757|NCT01617187|141502838|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.91||0.6099|TWO_SIDED|95.0|-2.3|1.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||1.3|-2.3|0.6099
70997758|NCT01617187|141502838|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.9|STANDARD_ERROR_OF_MEAN|0.82||0.279|TWO_SIDED|95.0|-0.7|2.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||2.5|-0.7|0.2790
70997759|NCT01617187|141502838|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.77||0.4253|TWO_SIDED|95.0|-2.1|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||0.9|-2.1|0.4253
70997760|NCT01617187|141502838|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.0|STANDARD_ERROR_OF_MEAN|0.96||0.3014|TWO_SIDED|95.0|-2.9|0.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||0.9|-2.9|0.3014
70997761|NCT01617187|141502838|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.87||0.972|TWO_SIDED|95.0|-1.7|1.7||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||1.7|-1.7|0.9720
70997762|NCT01617187|141502838|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.82||0.4758|TWO_SIDED|95.0|-2.2|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||1.0|-2.2|0.4758
70997763|NCT01617187|141502838|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|1.03||0.4419|TWO_SIDED|95.0|-2.8|1.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||1.2|-2.8|0.4419
70997764|NCT01617187|141502838|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.91||0.4762|TWO_SIDED|95.0|-2.4|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||1.1|-2.4|0.4762
70997765|NCT01617187|141502838|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.4|STANDARD_ERROR_OF_MEAN|0.86||0.1046|TWO_SIDED|95.0|-3.1|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||0.3|-3.1|0.1046
70997766|NCT01617187|141502838|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.6|STANDARD_ERROR_OF_MEAN|1.06||0.1411|TWO_SIDED|95.0|-3.7|0.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||0.5|-3.7|0.1411
70997767|NCT01617187|141502839|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.4||0.2754|TWO_SIDED|95.0|-1.2|0.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||0.4|-1.2|0.2754
71041165|NCT02102932|141590771|SUPERIORITY_OR_OTHER||Ratio of the geometric means|105.16|STANDARD_DEVIATION|6.2||0|TWO_SIDED|90.0|101.97|108.45||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||108.45|101.97|0.0000
71041166|NCT02102932|141590771|SUPERIORITY_OR_OTHER||Ratio of the geometric means|103.07|STANDARD_DEVIATION|6.6||0|TWO_SIDED|90.0|99.75|106.5||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||106.50|99.75|0.0000
71041167|NCT02102932|141590771|SUPERIORITY_OR_OTHER||Ratio of the geometric means|103.14|STANDARD_DEVIATION|7.5||0|TWO_SIDED|90.0|99.37|107.04||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||107.04|99.37|0.0000
71041168|NCT02102932|141590771|SUPERIORITY_OR_OTHER||Ratio of the geometric means|102.61|STANDARD_DEVIATION|7.0||0|TWO_SIDED|90.0|99.1|106.25||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||106.25|99.10|0.0000
71041169|NCT02102932|141590772|SUPERIORITY_OR_OTHER||Ratio of the geometric means|105.33|STANDARD_DEVIATION|11.9||0|TWO_SIDED|90.0|99.34|111.68||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||111.68|99.34|0.0000
71041170|NCT02102932|141590772|SUPERIORITY_OR_OTHER||Ratio of the geometric means|105.75|STANDARD_DEVIATION|13.2||0.0001|TWO_SIDED|90.0|99.09|112.85||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||112.85|99.09|0.0001
70997768|NCT01617187|141502839|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.39||0.85|TWO_SIDED|95.0|-0.8|0.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||0.7|-0.8|0.8500
70997769|NCT01617187|141502839|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.51||0.8439|TWO_SIDED|95.0|-1.1|0.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.9|-1.1|0.8439
70997770|NCT01617187|141502839|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.51||0.4741|TWO_SIDED|95.0|-1.4|0.6||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||0.6|-1.4|0.4741
70997771|NCT01617187|141502839|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.49||0.2158|TWO_SIDED|95.0|-1.6|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.4|-1.6|0.2158
70923838|NCT03703700|141339517|OTHER|||||||0.163|||||||Wilcoxon (Mann-Whitney)|||||||0.163
70997772|NCT01617187|141502839|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.63||0.506|TWO_SIDED|95.0|-1.7|0.8||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.8|-1.7|0.5060
70997773|NCT01617187|141502839|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.56||0.9956|TWO_SIDED|95.0|-1.1|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||1.1|-1.1|0.9956
70997774|NCT01617187|141502839|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.53||0.1624|TWO_SIDED|95.0|-1.8|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.3|-1.8|0.1624
70997775|NCT01617187|141502839|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.68||0.7662|TWO_SIDED|95.0|-1.5|1.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||1.1|-1.5|0.7662
70997776|NCT01617187|141502839|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.61||0.8363|TWO_SIDED|95.0|-1.3|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||1.1|-1.3|0.8363
70997777|NCT01617187|141502839|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.58||0.2388|TWO_SIDED|95.0|-1.8|0.5||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.5|-1.8|0.2388
70997778|NCT01617187|141502839|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.73||0.9435|TWO_SIDED|95.0|-1.5|1.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||1.4|-1.5|0.9435
70997779|NCT01617187|141502839|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.6|STANDARD_ERROR_OF_MEAN|0.7||0.4267|TWO_SIDED|95.0|-0.8|1.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||1.9|-0.8|0.4267
70997780|NCT01617187|141502839|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.65||0.681|TWO_SIDED|95.0|-1.6|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||1.0|-1.6|0.6810
70997781|NCT01617187|141502839|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.82||0.7673|TWO_SIDED|95.0|-1.4|1.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||1.9|-1.4|0.7673
70997782|NCT01617187|141502839|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.7||0.483|TWO_SIDED|95.0|-1.9|0.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||0.9|-1.9|0.4830
70997783|NCT01617187|141502839|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.66||0.2128|TWO_SIDED|95.0|-2.1|0.5||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.5|-2.1|0.2128
71041171|NCT02102932|141590772|SUPERIORITY_OR_OTHER||Ratio of the geometric means|102.9|STANDARD_DEVIATION|11.7||0|TWO_SIDED|90.0|97.11|109.03||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||109.03|97.11|0.0000
71041172|NCT02102932|141590772|SUPERIORITY_OR_OTHER||Ratio of the geometric means|93.84|STANDARD_DEVIATION|13.6||0.0002|TWO_SIDED|90.0|87.74|100.36||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||100.36|87.74|0.0002
70997784|NCT01617187|141502839|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.83||0.1756|TWO_SIDED|95.0|-2.8|0.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.5|-2.8|0.1756
70997785|NCT01617187|141502839|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.6|STANDARD_ERROR_OF_MEAN|0.72||0.4246|TWO_SIDED|95.0|-0.8|2.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||2.0|-0.8|0.4246
70997786|NCT01617187|141502839|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.68||0.2873|TWO_SIDED|95.0|-2.1|0.6||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||0.6|-2.1|0.2873
70997787|NCT01617187|141502839|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.83||0.7308|TWO_SIDED|95.0|-1.9|1.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||1.4|-1.9|0.7308
71100249|NCT02662582|141709123|SUPERIORITY||LSMean difference|0.2||||0.59|TWO_SIDED|90.0|-0.5|0.9||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.9|-0.5|0.590
71100250|NCT02662582|141709123|SUPERIORITY||LSMean difference|0.3||||0.399|TWO_SIDED|90.0|-0.3|0.9||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.9|-0.3|0.399
70997788|NCT01617187|141502840|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.4|STANDARD_ERROR_OF_MEAN|0.32||0.2116|TWO_SIDED|95.0|-0.2|1.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||1.0|-0.2|0.2116
70997789|NCT01617187|141502840|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.31||0.9039|TWO_SIDED|95.0|-0.6|0.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||0.7|-0.6|0.9039
70997790|NCT01617187|141502840|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.4||0.2959|TWO_SIDED|95.0|-1.2|0.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.4|-1.2|0.2959
70997791|NCT01617187|141502840|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.44||0.5909|TWO_SIDED|95.0|-1.1|0.6||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||0.6|-1.1|0.5909
70997792|NCT01617187|141502840|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.42||0.1489|TWO_SIDED|95.0|-1.4|0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.2|-1.4|0.1489
70997793|NCT01617187|141502840|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.54||0.1|TWO_SIDED|95.0|-2.0|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.2|-2.0|0.1000
70997794|NCT01617187|141502840|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.49||0.783|TWO_SIDED|95.0|-0.8|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||1.1|-0.8|0.7830
70997795|NCT01617187|141502840|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.47||0.2679|TWO_SIDED|95.0|-1.4|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.4|-1.4|0.2679
70997796|NCT01617187|141502840|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.2321|TWO_SIDED|95.0|-1.9|0.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||0.5|-1.9|0.2321
70997797|NCT01617187|141502840|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.56||0.7368|TWO_SIDED|95.0|-1.3|0.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||0.9|-1.3|0.7368
70997798|NCT01617187|141502840|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.53||0.4606|TWO_SIDED|95.0|-1.4|0.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.7|-1.4|0.4606
70997799|NCT01617187|141502840|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.66||0.3241|TWO_SIDED|95.0|-2.0|0.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||0.7|-2.0|0.3241
70997800|NCT01617187|141502840|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.57||0.986|TWO_SIDED|95.0|-1.1|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||1.1|-1.1|0.9860
70997801|NCT01617187|141502840|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.53||0.189|TWO_SIDED|95.0|-1.8|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||0.3|-1.8|0.1890
70997802|NCT01617187|141502840|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.67||0.303|TWO_SIDED|95.0|-2.0|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||0.6|-2.0|0.3030
70997803|NCT01617187|141502840|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.58||0.055|TWO_SIDED|95.0|-2.3|0.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||0.0|-2.3|0.0550
70997804|NCT01617187|141502840|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.55||0.0415|TWO_SIDED|95.0|-2.2|0.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||-0.0|-2.2|0.0415
71041173|NCT02250651|141590784|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.41||0.3738|TWO_SIDED|95.0|-1.17|0.44|||MMRM|||Change from Baseline at Week 12, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Week 12).||0.44|-1.17|0.3738
71041174|NCT02250651|141590784|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.41||0.8514|TWO_SIDED|95.0|-0.88|0.73|||MMRM|||Change from Baseline at Week 12, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Week 12).||0.73|-0.88|0.8514
70997805|NCT01617187|141502840|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.9|STANDARD_ERROR_OF_MEAN|0.69||0.0058|TWO_SIDED|95.0|-3.3|-0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||-0.6|-3.3|0.0058
70997806|NCT01617187|141502840|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.62||0.0691|TWO_SIDED|95.0|-2.3|0.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||0.1|-2.3|0.0691
70997807|NCT01617187|141502840|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.6|STANDARD_ERROR_OF_MEAN|0.58||0.0063|TWO_SIDED|95.0|-2.7|-0.5||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||-0.5|-2.7|0.0063
70997808|NCT01617187|141502840|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.0|STANDARD_ERROR_OF_MEAN|0.71||0.0056|TWO_SIDED|95.0|-3.4|-0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||-0.6|-3.4|0.0056
70997809|NCT01617187|141502841|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.34||0.7847|TWO_SIDED|95.0|-0.6|0.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||0.8|-0.6|0.7847
70997810|NCT01617187|141502841|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.33||0.5859|TWO_SIDED|95.0|-0.5|0.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||0.8|-0.5|0.5859
70997811|NCT01617187|141502841|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.43||0.6413|TWO_SIDED|95.0|-1.0|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.6|-1.0|0.6413
70997812|NCT01617187|141502841|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.38||0.7307|TWO_SIDED|95.0|-0.6|0.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||0.9|-0.6|0.7307
70997813|NCT01617187|141502841|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.37||0.7176|TWO_SIDED|95.0|-0.6|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.9|-0.6|0.7176
70997814|NCT01617187|141502841|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.48||0.486|TWO_SIDED|95.0|-1.3|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.6|-1.3|0.4860
70997815|NCT01617187|141502841|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.41||0.9321|TWO_SIDED|95.0|-0.8|0.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||0.8|-0.8|0.9321
70997816|NCT01617187|141502841|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.39||0.7691|TWO_SIDED|95.0|-0.7|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.9|-0.7|0.7691
70997817|NCT01617187|141502841|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.5||0.5694|TWO_SIDED|95.0|-1.3|0.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||0.7|-1.3|0.5694
70997818|NCT01617187|141502841|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.45||0.5583|TWO_SIDED|95.0|-0.6|1.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||1.2|-0.6|0.5583
70997819|NCT01617187|141502841|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.43||0.7307|TWO_SIDED|95.0|-0.7|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||1.0|-0.7|0.7307
70997820|NCT01617187|141502841|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.54||0.1715|TWO_SIDED|95.0|-1.8|0.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||0.3|-1.8|0.1715
70997821|NCT01617187|141502841|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.4|STANDARD_ERROR_OF_MEAN|0.55||0.4219|TWO_SIDED|95.0|-0.6|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||1.5|-0.6|0.4219
70997822|NCT01617187|141502841|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.52||0.7437|TWO_SIDED|95.0|-0.9|1.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||1.2|-0.9|0.7437
70997823|NCT01617187|141502841|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.65||0.311|TWO_SIDED|95.0|-1.9|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||0.6|-1.9|0.3110
70997824|NCT01617187|141502841|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.9805|TWO_SIDED|95.0|-1.0|1.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||1.0|-1.0|0.9805
70997825|NCT01617187|141502841|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.47||0.8741|TWO_SIDED|95.0|-1.0|0.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.8|-1.0|0.8741
70997826|NCT01617187|141502841|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.58||0.3288|TWO_SIDED|95.0|-1.7|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.6|-1.7|0.3288
70997827|NCT01617187|141502841|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.56||0.9336|TWO_SIDED|95.0|-1.0|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||1.1|-1.0|0.9336
70997828|NCT01617187|141502841|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.52||0.1722|TWO_SIDED|95.0|-1.7|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||0.3|-1.7|0.1722
70997829|NCT01617187|141502841|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.64||0.1909|TWO_SIDED|95.0|-2.1|0.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||0.4|-2.1|0.1909
70997830|NCT01617187|141502842|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.37||0.9851|TWO_SIDED|95.0|-0.7|0.7||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||0.7|-0.7|0.9851
70997831|NCT01617187|141502842|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.36||0.4912|TWO_SIDED|95.0|-0.9|0.5||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||0.5|-0.9|0.4912
70997832|NCT01617187|141502842|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.46||0.8559|TWO_SIDED|95.0|-1.0|0.8||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.8|-1.0|0.8559
70997833|NCT01617187|141502842|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.41||0.5635|TWO_SIDED|95.0|-0.6|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||1.1|-0.6|0.5635
70997834|NCT01617187|141502842|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.2321|TWO_SIDED|95.0|-1.3|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.3|-1.3|0.2321
70997835|NCT01617187|141502842|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.52||0.8867|TWO_SIDED|95.0|-1.1|0.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.9|-1.1|0.8867
70997836|NCT01617187|141502842|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.6|STANDARD_ERROR_OF_MEAN|0.42||0.1499|TWO_SIDED|95.0|-0.2|1.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||1.4|-0.2|0.1499
70997837|NCT01617187|141502842|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.4||0.286|TWO_SIDED|95.0|-1.2|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.4|-1.2|0.2860
70997838|NCT01617187|141502842|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.51||0.8978|TWO_SIDED|95.0|-1.1|0.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||0.9|-1.1|0.8978
70997839|NCT01617187|141502842|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|1.0|STANDARD_ERROR_OF_MEAN|0.44||0.0283|TWO_SIDED|95.0|0.1|1.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||1.8|0.1|0.0283
70997840|NCT01617187|141502842|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.41||0.8667|TWO_SIDED|95.0|-0.7|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.9|-0.7|0.8667
70997841|NCT01617187|141502842|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.52||0.5044|TWO_SIDED|95.0|-0.7|1.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||1.4|-0.7|0.5044
70997842|NCT01617187|141502842|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|1.4|STANDARD_ERROR_OF_MEAN|0.49||0.004|TWO_SIDED|95.0|0.5|2.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||2.4|0.5|0.0040
70997843|NCT01617187|141502842|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.46||0.633|TWO_SIDED|95.0|-0.7|1.1||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||1.1|-0.7|0.6330
70997844|NCT01617187|141502842|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.6|STANDARD_ERROR_OF_MEAN|0.57||0.2981|TWO_SIDED|95.0|-0.5|1.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||1.7|-0.5|0.2981
70997845|NCT01617187|141502842|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.45||0.6556|TWO_SIDED|95.0|-0.7|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||1.1|-0.7|0.6556
70997846|NCT01617187|141502842|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.43||0.2889|TWO_SIDED|95.0|-1.3|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.4|-1.3|0.2889
71100251|NCT02662582|141709124|SUPERIORITY||LSMean difference|-0.09||||0.151|TWO_SIDED|90.0|-0.2|0.01||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.01|-0.20|0.151
71100252|NCT02662582|141709125|SUPERIORITY||LSMean difference|-0.007||||0.857|TWO_SIDED|90.0|-0.07|0.056||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.056|-0.070|0.857
70997847|NCT01617187|141502842|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.53||0.9399|TWO_SIDED|95.0|-1.1|1.0||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||1.0|-1.1|0.9399
70997848|NCT01617187|141502842|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.54||0.8955|TWO_SIDED|95.0|-1.0|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||1.1|-1.0|0.8955
71100253|NCT02662582|141709126|SUPERIORITY||LSMean difference|1.56||||0.11|TWO_SIDED|90.0|-0.05|3.17||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||3.17|-0.05|0.110
70997849|NCT01617187|141502842|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.51||0.3681|TWO_SIDED|95.0|-1.5|0.5||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||0.5|-1.5|0.3681
70997850|NCT01617187|141502842|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.62||0.8215|TWO_SIDED|95.0|-1.4|1.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||1.1|-1.4|0.8215
70997851|NCT00595868|141502850|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.06|TWO_SIDED|95.0|1.0|2.9|||Chi-squared|||||2.9|1.0|0.06
70997852|NCT00595868|141502851|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1||||0.1|TWO_SIDED|95.0|0.9|5.2|||Chi-squared|||||5.2|0.9|0.10
70997853|NCT04268303|141502856|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
70997854|NCT04268303|141502856|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
70997855|NCT04268303|141502857|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 90 minutes post-dose||||<0.0001
70923839|NCT03703700|141339518|OTHER|||||||0.197|||||||Wilcoxon (Mann-Whitney)|||||||0.197
70923840|NCT03703700|141339519|OTHER|||||||0.178|||||||Wilcoxon (Mann-Whitney)|||||||0.178
70997856|NCT04268303|141502857|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 90 minutes post-dose||||<0.0001
70997857|NCT04268303|141502857|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 60 minutes post-dose||||<0.0001
70997858|NCT04268303|141502857|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 60 minutes post-dose||||<0.0001
70997859|NCT04268303|141502857|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 45 minutes post-dose||||<0.0001
70997860|NCT04268303|141502857|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 45 minutes post-dose||||<0.0001
70997861|NCT04268303|141502857|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 30 minutes post-dose||||<0.0001
70997862|NCT04268303|141502857|SUPERIORITY|||||||0.0075|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 30 minutes post-dose||||0.0075
70997863|NCT04268303|141502857|SUPERIORITY|||||||0.0032|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 20 minutes post-dose||||0.0032
70997864|NCT04268303|141502857|SUPERIORITY|||||||0.4097|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 20 minutes post-dose||||0.4097
70997865|NCT04268303|141502857|SUPERIORITY|||||||0.0457|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 10 minutes post-dose||||0.0457
70997866|NCT04268303|141502857|SUPERIORITY|||||||0.972|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 10 minutes post-dose||||0.9720
70997867|NCT05742841|141502871|SUPERIORITY||Median Difference (Final Values)|-16.5|||||TWO_SIDED|||||||||||||
70997868|NCT00223652|141502920|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||=.001
71100254|NCT02662582|141709127|SUPERIORITY||LSMean difference|2.07||||0.766|TWO_SIDED|90.0|-9.57|13.71||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||13.71|-9.57|0.766
71100255|NCT02662582|141709127|SUPERIORITY||LSMean difference|2.94||||0.642|TWO_SIDED|90.0|-7.66|13.54||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||13.54|-7.66|0.642
71100256|NCT00318136|141709152|SUPERIORITY_OR_OTHER||Percentage of patients|3.2||||||90.0|0.3|13.5|||Blyth-Still-Casella|||||13.5|0.3|
71041175|NCT02250651|141590784|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.39||0.0401|TWO_SIDED|95.0|-1.57|-0.04|||MMRM|||Change from Baseline at Week 12, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Week 12).||-0.04|-1.57|0.0401
71100257|NCT03769116|141709196|OTHER||Hodges-Lehmann treatment diff|6.11|||<|0.0001|TWO_SIDED|95.0|2.08|12.58|||Wilcoxon rank sum test|||Analysis conducted on changes from baseline.||12.58|2.08|< 0.0001
70923841|NCT03703700|141339520|OTHER|||||||0.549|||||||Wilcoxon (Mann-Whitney)|||||||0.549
70997869|NCT00223652|141502920|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Mixed Models Analysis|||||||0.07
70997870|NCT00223652|141502920|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||Mixed Models Analysis|||||||0.95
70997871|NCT00223652|141502921|SUPERIORITY_OR_OTHER||||||>|0.37|TWO_SIDED||||||Mixed Models Analysis|||||||>0.37
70997872|NCT00223652|141502922|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<.0001
70997873|NCT00223652|141502922|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Mixed Models Analysis|||||||0.61
70997874|NCT00223652|141502922|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Mixed Models Analysis|||||||0.20
70997875|NCT00223652|141502923|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Generalized estimating equations models|||||||<0.0001
70997876|NCT00223652|141502923|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Generalized estimating equations models|||||||0.12
70997877|NCT00223652|141502923|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Generalized estimating equations models|||||||0.86
70997878|NCT00223652|141502924|SUPERIORITY_OR_OTHER||||||>|0.37|TWO_SIDED||||||Mixed Models Analysis|||||||>0.37
70997879|NCT00223652|141502925|SUPERIORITY_OR_OTHER||||||>|0.37|TWO_SIDED||||||Generalized estimating equations models|||||||>0.37
70997880|NCT01878097|141502981|SUPERIORITY||F-stat|7.12||||0.0003|TWO_SIDED||||||Mixed Models Analysis|||||||0.0003
70997881|NCT01878097|141502982|SUPERIORITY||F-stat|7.18||||0.0003|TWO_SIDED||||||Mixed Models Analysis|||||||0.0003
70997882|NCT05034614|141503018|SUPERIORITY|||||||0.75|||||||Chi-squared|||||||.75
70997883|NCT03892707|141503022|SUPERIORITY|The between-group comparison on primary endpoint - change from baseline in pain intensity as measured on 0-10 points NRS scale at 10 days after the start of treatment was performed using analysis of covariance (ANCOVA). The difference between pain intensity at 10 days after the start of treatment and baseline (V3-V1) as response variable, treatment group as fixed factor and baseline pain intensity as a covariate was included into the model.|||||<|0.001|||||||ANCOVA|||"Since the superiority of one treatment over the other is investigated and taking into consideration that smaller negative values of the primary variable correspond to the greater reduction of pain, the statistical hypotheses are:~Null hypothesis (H0):~H0: μ2 - μ1 ≥ 0~Alternative hypothesis (HA):~HA: μ2 - μ1 \< 0, where μ1 и μ2 are the mean changes from baseline in pain intensity for (1) modern NSAIDs therapy and for (2) modern NSAIDs + Milgamma\\ Milgamma compositum therapy, correspondingly."||||<0.001
70997884|NCT03892707|141503023|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Changes from baseline in pain intensity measured on 0-10 points NRS scale at 5, 24 and 38 days after were compared between groups using ANCOVA models similar to those used for the analysis of the primary variable.||||<0.001
70997885|NCT03892707|141503024|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
70997886|NCT03892707|141503025|SUPERIORITY|Between-group comparison was carried out using logistic regression with treatment group as fixed factor and baseline pain intensity as a covariate. Treatment effect was tested using the corresponding p-value.|||||<|0.001|||||||Regression, Logistic|||For Visit 2 (5 days after the start of treatment) relief in pain intensity was defined as 100%\*(pain intensity at baseline - pain intensity at Visit 2)/ pain intensity at baseline. The denominator for the proportion of patients was the number of patients with available pain intensity measurements after imputation using Last observation carried forward (LOCF) method.||||<0.001
70997887|NCT03892707|141503025|SUPERIORITY|Between-group comparison was carried out using logistic regression with treatment group as fixed factor and baseline pain intensity as a covariate. Treatment effect was tested using the corresponding p-value.|||||<|0.001|||||||Regression, Logistic|||For Visit 3 (10 days after the start of treatment) relief in pain intensity was defined as 100%\*(pain intensity at baseline - pain intensity at Visit 3)/ pain intensity at baseline. The denominator for the proportion of patients was the number of patients with available pain intensity measurements after imputation using Last observation carried forward (LOCF) method.||||<0.001
70997888|NCT03892707|141503025|SUPERIORITY|Between-group comparison was carried out using logistic regression with treatment group as fixed factor and baseline pain intensity as a covariate. Treatment effect was tested using the corresponding p-value.||||||0.061|||||||Regression, Logistic|||For Visit 4 (24 days after the start of treatment) relief in pain intensity was defined as 100%\*(pain intensity at baseline - pain intensity at Visit 4)/ pain intensity at baseline. The denominator for the proportion of patients was the number of patients with available pain intensity measurements after imputation using Last observation carried forward (LOCF) method.||||0.061
70997889|NCT03892707|141503026|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Change from baseline in pain-related disability as measured by Roland Morris disability questionnaire at 10 days after the start of treatment was compared between groups using analysis of covariance (ANCOVA) model with treatment group as fixed factor and baseline value disability score as a covariate.||||<0.001
70997890|NCT03892707|141503027|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||Episode of pain flare-up was defined as presence of at least 1 day with pain following a period without pain lasting at least 4 weeks . The denominator for the proportion was the number of FAS patients who had at least one pain-free period with approximately 4 weeks duration registered during the study.||||<0.001
71100258|NCT03769116|141709197|OTHER||LSM Change Difference|0.8|STANDARD_ERROR_OF_MEAN|0.9|=|0.373|TWO_SIDED|95.0|-1.0|2.7|||Mixed-model for Repeated Measures|||||2.7|-1.0|= 0.3730
71100259|NCT03769116|141709205|OTHER||LSM Change Difference|2.5|STANDARD_ERROR_OF_MEAN|0.9|=|0.0172|TWO_SIDED|95.0|0.5|4.4|||Mixed-model for Repeated Measures|||Change from baseline - Age Group: 4-5 years old||4.4|0.5|= 0.0172
71100260|NCT03769116|141709205|OTHER||LSM Change Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.1|=|0.5384|TWO_SIDED|95.0|-3.0|1.6|||Mixed-model for Repeated Measures|||Change from baseline - Age Group: 6-7 years old||1.6|-3.0|= 0.5384
70997891|NCT03892707|141503028|SUPERIORITY||Difference in proportion|28.6|||||TWO_SIDED|95.0|-3.6|60.7||||||Difference in proportion of patients with at least one pain flare-up resulting in consultancy with physician||60.7|-3.6|
70997892|NCT03892707|141503028|SUPERIORITY||Difference in proportion|-17.1|||||TWO_SIDED|95.0|-51.6|17.4||||||Difference in proportion of patients with at least one pain flare-up resulting in disruption of daily activity||17.4|-51.6|
70997893|NCT03892707|141503028|SUPERIORITY||Difference in proportion|25.7|||||TWO_SIDED|95.0|-4.1|55.5||||||Difference in proportion of patients with at least one pain flare-up resulting in NSAIDs intake||55.5|-4.1|
70997894|NCT03892707|141503029|SUPERIORITY|||||||0.986|||||||Wilcoxon (Mann-Whitney)|||NSAIDs intake during the study was analyzed. In order to calculate the total number of treatment days with NSAIDs, first, intersecting or adjacent records were collapsed, irrespective of the specific drug used; the duration of each of the resulting intake periods was determined as (End date - Start date + 1) and, finally, all individual duration values were summed up. In case medication intake was ongoing at the end of study, end date was imputed by the date of study completion.||||0.986
70997895|NCT03892707|141503032|SUPERIORITY|||||||0.921|||||||Wilcoxon (Mann-Whitney)|||Comparison of patient satisfaction with treatment between treatment groups after 5 days since the start of study treatment.||||0.921
71041176|NCT02250651|141590784|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.39||0.3621|TWO_SIDED|95.0|-1.12|0.41|||MMRM|||Change from Baseline at Week 12, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Week 12).||0.41|-1.12|0.3621
70997896|NCT03892707|141503032|SUPERIORITY|||||||0.051|||||||Wilcoxon (Mann-Whitney)|||Comparison of patient satisfaction with treatment between treatment groups after 10 days since the start of study treatment||||0.051
70997897|NCT03892707|141503032|SUPERIORITY|||||||0.651|||||||Wilcoxon (Mann-Whitney)|||Comparison of patient satisfaction with treatment between treatment groups after 38 days since the start of study treatment||||0.651
70997898|NCT03892707|141503032|SUPERIORITY|||||||0.106|||||||Wilcoxon (Mann-Whitney)|||Comparison of patient satisfaction with treatment between treatment groups after 3 months since the start of study treatment||||0.106
70997899|NCT02141217|141503108|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of non-inferiority was based on Farrington and Manning method. The upper limit of two-sided 95% confidence interval of less than 10 % provide enough evidence to show the non-inferiority between the treatment arms.|Treatment Difference (percentage)|1.5|||||TWO_SIDED|95.0|-4.9|8.0||||||||8.0|-4.9|
70997900|NCT02141217|141503109|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of non-inferiority was based on Farrington and Manning method. The upper limit of two-sided 95% confidence interval of less than 10 % provide enough evidence to show the non-inferiority between the treatment arms.|Treatment Difference (percentage)|0.9|||||TWO_SIDED|95.0|-5.6|7.4||||||||7.4|-5.6|
70997901|NCT02141217|141503110|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of non-inferiority was based on Farrington and Manning method. The upper limit of two-sided 95% confidence interval of less than 10 % provide enough evidence to show the non-inferiority between the treatment arms.|Treatment Difference (percentage)|2.3|||||TWO_SIDED|95.0|-4.4|9.0||||||||9.0|-4.4|
70997902|NCT01181141|141503122|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|-3.5|||||TWO_SIDED|95.0|-18.8|6.0|||Wilcoxon (Mann-Whitney)|||||6.0|-18.8|
70997903|NCT01226706|141503128|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||"A sample of 16 subjects per group was required to detect a mean difference of 50 mL in maximum capacity at cystoscopy between botulinum toxin and placebo at 90% power with a two-sided type I error of 5%.~Difference scores were computed for the primary outcome, which were then compared using the Wilcoxon- Mann-Whitney U test. This type of analysis was used to identify both between group differences and within group differences (over time) while using non-parametric statistics."||||.016
70997904|NCT01226706|141503129|SUPERIORITY_OR_OTHER|||||||0.152|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.152
70997905|NCT01226706|141503130|SUPERIORITY_OR_OTHER|||||||0.095|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.095
70997906|NCT01226706|141503131|SUPERIORITY_OR_OTHER|||||||0.067|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.067
70997907|NCT01226706|141503135|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.038
70997908|NCT01226706|141503136|SUPERIORITY_OR_OTHER|||||||0.095|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.095
70997909|NCT01226706|141503137|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.038
70997910|NCT01226706|141503141|SUPERIORITY_OR_OTHER|||||||0.904|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.904
70997911|NCT01226706|141503142|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.080
70997912|NCT01226706|141503143|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.230
70997913|NCT01226706|141503147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.021|TWO_SIDED|95.0|-2.1|-0.2|||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||-0.2|-2.1|0.021
70997914|NCT01226706|141503148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.007|TWO_SIDED|95.0|-2.1|-0.5|||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||-0.5|-2.1|0.007
70997915|NCT01226706|141503149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.013|TWO_SIDED|95.0|-2.0|-0.4|||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||-0.4|-2.0|0.013
70997916|NCT01226706|141503150|SUPERIORITY_OR_OTHER|||||||0.173|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.173
70997917|NCT01226706|141503151|SUPERIORITY_OR_OTHER|||||||0.051|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.051
70997918|NCT01226706|141503152|SUPERIORITY_OR_OTHER|||||||0.051|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.051
70997919|NCT01226706|141503153|SUPERIORITY_OR_OTHER|||||||0.557|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.557
70997920|NCT01226706|141503154|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.029
70997921|NCT01226706|141503155|SUPERIORITY_OR_OTHER|||||||0.132|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.132
70997922|NCT01226706|141503156|SUPERIORITY_OR_OTHER|||||||0.085|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.085
70997923|NCT01226706|141503157|SUPERIORITY_OR_OTHER|||||||0.099|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.099
70997924|NCT01226706|141503158|SUPERIORITY_OR_OTHER|||||||0.132|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.132
70923842|NCT03703700|141339521|OTHER||Risk Ratio (RR)|1.19||||0.035|TWO_SIDED|95.0|1.01|1.4|||Chi-squared|||||1.40|1.01|0.035
70997925|NCT01226706|141503159|SUPERIORITY_OR_OTHER|||||||0.072|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.072
70997926|NCT01226706|141503160|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.230
70923843|NCT03703700|141339522|OTHER||Risk Ratio (RR)|1.18||||0.034|TWO_SIDED|95.0|1.01|1.37|||Chi-squared|||||1.37|1.01|0.034
70923844|NCT03703700|141339523|OTHER||Risk Ratio (RR)|1.22||||0.022|TWO_SIDED|95.0|1.03|1.45|||Chi-squared|||||1.45|1.03|0.022
70997927|NCT01226706|141503161|SUPERIORITY_OR_OTHER|||||||0.314|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.314
70997928|NCT01226706|141503162|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.013
70997929|NCT01226706|141503163|SUPERIORITY_OR_OTHER|||||||0.888|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.888
70997930|NCT03819478|141503245|SUPERIORITY|||||||0.488|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.4880
70997931|NCT03819478|141503245|SUPERIORITY|||||||0.1683|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.1683
70997932|NCT03819478|141503246|SUPERIORITY|||||||0.7636|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.7636
70997933|NCT03819478|141503247|SUPERIORITY|||||||0.1584|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.1584
70997934|NCT03819478|141503247|SUPERIORITY|||||||0.1623|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.1623
70997935|NCT03819478|141503248|SUPERIORITY|||||||0.035|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.0350
70997936|NCT03819478|141503249|SUPERIORITY|||||||0.2422|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.2422
70997937|NCT03819478|141503249|SUPERIORITY|||||||0.5082|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.5082
70997938|NCT03819478|141503250|SUPERIORITY|||||||0.5119|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.5119
70997939|NCT03819478|141503250|SUPERIORITY|||||||0.4902|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.4902
70997940|NCT03819478|141503251|SUPERIORITY|||||||0.85|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.8500
70997941|NCT03819478|141503252|SUPERIORITY|||||||0.3685|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.3685
70997942|NCT03819478|141503252|SUPERIORITY|||||||0.0894|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.0894
70997943|NCT03819478|141503253|SUPERIORITY|||||||0.5334|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.5334
70997944|NCT03819478|141503254|SUPERIORITY|||||||0.1573|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.1573
71008551|NCT02055976|141525224|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.262|STANDARD_ERROR_OF_MEAN|3.696|<|0.001|TWO_SIDED|95.0|-63.603|-48.921|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-48.921|-63.603|<0.001
70997945|NCT01135017|141503255|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean difference|-59.13|STANDARD_ERROR_OF_MEAN|0.275||0.0015|TWO_SIDED|95.0|-76.322|-29.457||No adjustment for multiplicity was made. The priori threshold for statistical significance was ≤0.05.|ANCOVA|ANCOVA model on log-transformed AF burden data with treatment arm as a fixed effect term and baseline log-transformed AF burden as a covariate|"Percent change in AF burden with dronedarone relative to placebo~LS Mean difference from the ANCOVA model on log-transformed AF burden data was exponentiated to convert back to percent change."|"The planned sample size of 286 participants was estimated to have 70% power to detect a reduction in mean AF burden of 30% relative to the placebo group.~Due to the smaller-than-planned sample size, the power to detect this difference was estimated to be only 44%, based on the original assumption. However, the power to detect larger treatment effects (\>40% reduction) remained high and the posthoc power to detect a 60% reduction in AF burden was 99%."||-29.457|-76.322|0.0015
70997946|NCT01170221|141503262|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the observed difference in the primary outcome measure (early clinical response at the 48-72 Hour Visit) between the tedizolid group and the linezolid group was calculated using the ITT analysis set. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10%.|Risk Difference (RD)|0.1||||||95.0|-6.1|6.2|||||Risk difference corresponds to tedizolid clinical response rate minus linezolid clinical response rate. The confidence interval was calculated using the Miettinen and Nurminen with stratification for the presence or absence of fever at baseline.|The primary objective is to determine the noninferiority in the early clinical response rate of oral tedizolid phosphate compared with that of oral linezolid treatment at the 48-72 Hour Visit in the ITT Analysis Set in patients with ABSSSI.||6.2|-6.1|
70997947|NCT01170221|141503263|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI will be calculated for the observed differences in the clinical response rate based on the sustained response at EOT using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-2.6|||||TWO_SIDED|95.0|-9.6|4.2||Hierarchical testing procedure of Westfall and Krishen used to control for inflation of the overall type I error rate. If NI is declared for the primary, NI will be tested for the secondary outcomes in this order: Secondary Outcomes Measures 2 to 5.|||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|||4.2|-9.6|
70997948|NCT01170221|141503264|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the sustained response at EOT using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-0.9|||||TWO_SIDED|95.0|-7.7|5.4|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|||5.4|-7.7|
70997949|NCT01170221|141503265|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the clinical success rate based on the Investigator's assessment of clinical response at the PTE visit using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-0.5|||||TWO_SIDED|95.0|-5.8|4.9|||||Risk difference corresponds to the tedizolid clinical success rate minus the linezolid clinical success rate.|||4.9|-5.8|
70997950|NCT01170221|141503266|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the clinical success rate based on the Investigator's assessment of clinical response at the PTE visit using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-0.8|||||TWO_SIDED|95.0|-4.6|3.0|||||Risk difference corresponds to the tedizolid clinical success rate minus the linezolid clinical success rate.|||3.0|-4.6|
70997951|NCT01170221|141503267|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.5|||||TWO_SIDED|95.0|-1.4|8.5|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the Investigator's assessment of clinical response at the 48-72 Hour Visit using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline.||8.5|-1.4|
70997952|NCT01170221|141503268|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.7|||||TWO_SIDED|95.0|-2.8|6.4|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the Investigator's assessment of clinical response at the Day 7 Visit using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline.||6.4|-2.8|
70997953|NCT01948141|141503289|SUPERIORITY_OR_OTHER|||||||0.59|||||||Log Rank|||||||0.59
70997954|NCT01948141|141503292|SUPERIORITY_OR_OTHER|||||||0.36|||||||Log Rank|||||||0.36
71041177|NCT02250651|141590785|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.36||0.0382||95.0|-1.48|-0.04|||MMRM|||Week 2, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.04|-1.48|0.0382
70997955|NCT04682353|141503301|OTHER||Geometric Mean Ratio|0.976|||||TWO_SIDED|90.0|0.748|1.274||||||||1.274|0.748|
70997956|NCT04682353|141503301|OTHER||Geometric Mean Ratio|1.226|||||TWO_SIDED|90.0|0.94|1.598||||||||1.598|0.940|
70997957|NCT04682353|141503301|OTHER||Geometric Mean Ratio|1.817|||||TWO_SIDED|90.0|1.38|2.392||||||||2.392|1.380|
70997958|NCT04682353|141503303|OTHER||Geometric Mean Ratio|1.202|||||TWO_SIDED|90.0|0.96|1.506||||||||1.506|0.960|
70997959|NCT04682353|141503303|OTHER||Geometric Mean Ratio|1.393|||||TWO_SIDED|90.0|1.07|1.815||||||||1.815|1.070|
70997960|NCT04682353|141503303|OTHER||Geometric Mean Ratio|2.301|||||TWO_SIDED|90.0|1.806|2.933||||||||2.933|1.806|
70997961|NCT04682353|141503304|OTHER||Geometric Mean Ratio|1.699|||||TWO_SIDED|90.0|0.921|3.135||||||||3.135|0.921|
70997962|NCT04682353|141503304|OTHER||Geometric Mean Ratio|2.364|||||TWO_SIDED|90.0|1.273|4.39||||||||4.390|1.273|
70997963|NCT04682353|141503304|OTHER||Geometric Mean Ratio|3.748|||||TWO_SIDED|90.0|2.033|6.908||||||||6.908|2.033|
70997964|NCT04682353|141503305|OTHER||Geometric Mean Ratio|1.904|||||TWO_SIDED|90.0|0.886|4.093||||||||4.093|0.886|
70997965|NCT04682353|141503305|OTHER||Geometric Mean Ratio|3.317|||||TWO_SIDED|90.0|1.585|6.942||||||||6.942|1.585|
70997966|NCT04682353|141503305|OTHER||Geometric Mean Ratio|5.824|||||TWO_SIDED|90.0|2.796|12.135||||||||12.135|2.796|
70997967|NCT04682353|141503306|OTHER||Geometric Mean Ratio|1.095|||||TWO_SIDED|90.0|0.92|1.302||||||||1.302|0.920|
71041178|NCT02250651|141590785|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.36||0.1133||95.0|-1.29|0.14|||MMRM|||Week 2, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.14|-1.29|0.1133
70997968|NCT04682353|141503306|OTHER||Geometric Mean Ratio|1.415|||||TWO_SIDED|90.0|1.148|1.744||||||||1.744|1.148|
70997969|NCT04682353|141503306|OTHER||Geometric Mean Ratio|2.017|||||TWO_SIDED|90.0|1.692|2.405||||||||2.405|1.692|
70923845|NCT03703700|141339524|OTHER||Risk Ratio (RR)|0.94||||0.707|TWO_SIDED|95.0|0.68|1.3|||Chi-squared|||||1.30|0.68|0.707
70997970|NCT04682353|141503307|OTHER||Geometric Mean Ratio|1.112|||||TWO_SIDED|90.0|0.948|1.303||||||||1.303|0.948|
70997971|NCT04682353|141503307|OTHER||Geometric Mean Ratio|1.439|||||TWO_SIDED|90.0|1.174|1.762||||||||1.762|1.174|
70997972|NCT04682353|141503307|OTHER||Geometric Mean Ratio|2.075|||||TWO_SIDED|90.0|1.751|2.459||||||||2.459|1.751|
70997973|NCT04682353|141503308|OTHER||Geometric Mean Ratio|1.115|||||TWO_SIDED|90.0|0.993|1.252||||||||1.252|0.993|
70997974|NCT04682353|141503308|OTHER||Geometric Mean Ratio|1.53|||||TWO_SIDED|90.0|1.277|1.833||||||||1.833|1.277|
70997975|NCT04682353|141503308|OTHER||Geometric Mean Ratio|2.14|||||TWO_SIDED|90.0|1.888|2.425||||||||2.425|1.888|
70997976|NCT03846219|141503358|SUPERIORITY||rate ratio|0.38||||0.0002|TWO_SIDED|95.0|0.22|0.64||A one-sided alpha level of 0.1 was used.|generalized linear model|Estimates were adjusted for baseline volume of T2 lesions, MRI field strength (1.5 or 3.0 Tesla), and baseline number of Gd+ lesions (0, ≥1).|Rate ratio of 45 mg IMU-838 / placebo|H0: cumulative number of CUA MRI lesions up to Week 24 with 45 mg IMU-838 equal to or higher than that with placebo. A generalized linear model with a negative binomial distribution and logarithmic link function was used. Log transformation of time from 1st IMP dose to date of last MRI assessment was used as offset term. 51 patients per group were necessary to have 80% power to detect a difference of 3.5 in mean event rate with a significance level 0.1, 1-sided.||0.64|0.22|0.0002
70997977|NCT03846219|141503359|SUPERIORITY||Rate ratio|0.3|||<|0.0001|TWO_SIDED|95.0|0.17|0.53||A hierarchical testing procedure with a one-sided alpha level of 0.1 was used.|Generalized linear model|Estimates were adjusted for baseline volume of T2 lesions, MRI field strength (1.5 or 3.0 Tesla), and baseline number of Gd+ lesions (0, ≥1).|Rate ratio of 30 mg IMU-838 / placebo|A generalized linear model with a negative binomial distribution and logarithmic link function was used. Log transformation of time from 1st IMP dose to date of last MRI assessment was used as offset term.||0.53|0.17|<.0001
70997978|NCT02293902|141503430|SUPERIORITY||Odds Ratio (OR)|12.185|||<|0.0001|TWO_SIDED|95.0|5.583|26.594||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) test stratified by prior biologic use (Yes, No) and weight at screening (\<55 kg, \>=55 kg).|Placebo vs. Sarilumab 150 mg|26.594|5.583|<0.0001
70997979|NCT02293902|141503430|SUPERIORITY||Odds Ratio (OR)|7.227|||<|0.0001|TWO_SIDED|95.0|3.446|15.158||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using CMH test stratified by prior biologic use (Yes, No) and weight at screening (\<55 kg, \>=55 kg).|Placebo vs. Sarilumab 200 mg|15.158|3.446|<0.0001
70997980|NCT03351478|141503471|SUPERIORITY||Difference in Least Square (LS) Means|-0.43|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.62|-0.25|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline HbA1c as a covariate.||-0.25|-0.62|< 0.0001
70997981|NCT03351478|141503471|SUPERIORITY||Difference in LS Means|0.12|STANDARD_ERROR_OF_MEAN|0.08||0.145|TWO_SIDED|95.0|-0.04|0.28|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline HbA1c as a covariate.||0.28|-0.04|0.145
70997982|NCT03351478|141503472|SUPERIORITY||Difference in LS Means|-2.05|STANDARD_ERROR_OF_MEAN|1.43||0.1529|TWO_SIDED|95.0|-4.87|0.76|||ANCOVA|||The change from baseline to Week 12 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No) and the country as fixed effects, and baseline SBP as a covariate.||0.76|-4.87|0.1529
70997983|NCT03351478|141503472|SUPERIORITY||Difference in LS Means|1.17|STANDARD_ERROR_OF_MEAN|1.21||0.3377|TWO_SIDED|95.0|-1.21|3.55|||ANCOVA|||The change from baseline to Week 12 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No) and the country as fixed effects, and baseline SBP as a covariate.||3.55|-1.21|0.3377
70997984|NCT03351478|141503473|SUPERIORITY||Difference in LS Means|-0.91|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.33|-0.5|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline 2-hour postprandial glucose as a covariate.||-0.5|-1.33|<0.0001
71041179|NCT02250651|141590786|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.34||0.0013||95.0|-1.76|-0.43|||MMRM|||Week 2, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.43|-1.76|0.0013
71041180|NCT02250651|141590786|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.34||0.0364||95.0|-1.38|-0.05|||MMRM|||Week 2, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.05|-1.38|0.0364
71041181|NCT02250651|141590787|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.38||0.2304||95.0|-1.22|0.29|||MMRM|||Week 6, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.29|-1.22|0.2304
71041182|NCT02250651|141590787|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.38||0.1272||95.0|-1.34|0.17|||MMRM|||Week 6, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.17|-1.34|0.1272
71041183|NCT02250651|141590788|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.36||0.0038||95.0|-1.76|-0.34|||MMRM|||Week 6, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.34|-1.76|0.0038
71041184|NCT02250651|141590788|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.36||0.0741||95.0|-1.36|0.06|||MMRM|||Week 6, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.06|-1.36|0.0741
71041185|NCT02250651|141590789|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.41||0.3738||95.0|-1.17|0.44|||MMRM|||Week 12, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.44|-1.17|0.3738
71100261|NCT02844075|141709208|SUPERIORITY||||||||||||||||||For sample size calculation, Minimax design to evaluate the null hypothesis that the true pCR rate will be 10% and the alternative hypothesis that the pCR rate≥ 30%, with type I error (α) level of 10% and type II error (β) of 0.10. If 1 or more successes are observed in the first 16 patients, accrual for that stratum will be continued until a total of 25 patients. If, of these 25 patients, 5 or more pCR, an additional investigation is warranted. Allowing for a follow-up loss rate of 10 %, the total sample size is expected as 28. For biomarker evaluation, the categorical groups were investigated to evaluated possible association with response and/or survival. Associations were analyzed by χ2 test or Fisher's exact test for categorical variables. The Kaplan-Meier method was used to analyze survival outcomes (EFS, OS, and DFS). To compare PD-L1 expression between paired pre- and post-neoadjuvant treatment with associated of pCR, the Wilcoxon signed-rank test was used.|||
70997985|NCT03351478|141503473|SUPERIORITY||Difference in LS Means|-0.03|STANDARD_ERROR_OF_MEAN|0.17||0.8397|TWO_SIDED|95.0|-0.37|0.3|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥ 130 mmHg) at screening, and the country as fixed effects, and baseline 2-hour postprandial glucose as a covariate.||0.3|-0.37|0.8397
70997986|NCT03351478|141503474|SUPERIORITY||Difference in LS Means|-0.8|STANDARD_ERROR_OF_MEAN|0.23||0.0005|TWO_SIDED|95.0|-1.25|-0.35|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline fasting plasma glucose as a covariate.||-0.35|-1.25|0.0005
70997987|NCT03351478|141503474|SUPERIORITY||Difference in LS Means|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1339|TWO_SIDED|95.0|-0.09|0.7|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline fasting plasma glucose as a covariate.||0.7|-0.09|0.1339
70997988|NCT03351478|141503475|SUPERIORITY||Difference in LS Means|-2.25|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.95|-1.54|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline weight as a covariate.||-1.54|-2.95|<0.0001
70997989|NCT03351478|141503475|SUPERIORITY||Difference in LS Means|0.51|STANDARD_ERROR_OF_MEAN|0.34||0.1407|TWO_SIDED|95.0|-0.17|1.19|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline weight as a covariate.||1.19|-0.17|0.1407
70997990|NCT03351478|141503476|SUPERIORITY||Difference in LS Means|-2.03|STANDARD_ERROR_OF_MEAN|0.95||0.0325|TWO_SIDED|95.0|-3.89|-0.17|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No) and the country as fixed effects, and baseline SBP as a covariate.||-0.17|-3.89|0.0325
70997991|NCT03351478|141503476|SUPERIORITY||Difference in LS Means|1.1|STANDARD_ERROR_OF_MEAN|0.78||0.1565|TWO_SIDED|95.0|-0.42|2.63|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No) and the country as fixed effects, and baseline SBP as a covariate.||2.63|-0.42|0.1565
70997992|NCT03351478|141503477|SUPERIORITY||percentage difference|8.1||||0.0048|TWO_SIDED|95.0|3.36|12.89|||Cochran-Mantel-Haenszel|||The percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), and the randomization strata of mean SBP (\<130, ≥130 mmHg) at the screening.||12.89|3.36|0.0048
70997993|NCT03351478|141503478|SUPERIORITY||Percentage Difference|16.9||||0.0001|TWO_SIDED|95.0|9.26|24.52|||Cochran-Mantel-Haenszel|||The percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), and the randomization strata of mean SBP (\<130, ≥130 mmHg) at the screening.||24.52|9.26|0.0001
70997994|NCT00510484|141503479|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
70997995|NCT00510484|141503480|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
70997996|NCT00510484|141503481|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
70997997|NCT00510484|141503482|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
70997998|NCT00510484|141503483|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
70923846|NCT03703700|141339525|OTHER||Risk Ratio (RR)|0.97||||0.878|TWO_SIDED|95.0|0.66|1.42|||Chi-squared|||||1.42|0.66|0.878
70997999|NCT00510484|141503484|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
70998000|NCT00510484|141503485|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||0.013
70998001|NCT00510484|141503486|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
70998002|NCT00762268|141503494|SUPERIORITY_OR_OTHER|||||||1|||||||Regression, Linear|||||||1.0
71041186|NCT02250651|141590789|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.41||0.8514||95.0|-0.88|0.73|||MMRM|||Week 12, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.73|-0.88|0.8514
71041187|NCT02250651|141590790|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.39||0.0401||95.0|-1.57|-0.04|||MMRM|||Week 12, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.04|-1.57|0.0401
71041188|NCT02250651|141590790|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.39||0.3621|TWO_SIDED|95.0|-1.12|0.41|||MMRM|||Week 12, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.41|-1.12|0.3621
70998003|NCT00762268|141503495|OTHER|||||||0.05|||||||Chi-squared|||Change from intake scores.||||0.05
71041189|NCT02250651|141590791|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.36||0.0382|TWO_SIDED|95.0|-1.48|-0.04|||MMRM|||Change from Baseline at Week 2, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.04|-1.48|0.0382
71041190|NCT02250651|141590791|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.36||0.1133|TWO_SIDED|95.0|-1.29|0.14|||MMRM|||Change from Baseline at Week 2, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.14|-1.29|0.1133
71041191|NCT02250651|141590791|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.34||0.0013|TWO_SIDED|95.0|-1.76|-0.43|||MMRM|||Change from Baseline at Week 2, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.43|-1.76|0.0013
71041192|NCT02250651|141590791|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.34||0.0364|TWO_SIDED|95.0|-1.38|-0.05|||MMRM|||Change from Baseline at Week 2, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.05|-1.38|0.0364
70923847|NCT03703700|141339526|OTHER|||||||0.564|||||||Wilcoxon (Mann-Whitney)|||Singleton||||0.564
70998004|NCT00762268|141503496|OTHER|||||||0.05|TWO_SIDED|95.0|||||Chi-squared|||||||0.05
70998005|NCT00961441|141503497|SUPERIORITY_OR_OTHER||Point estimate for ratio|1.0271|||||TWO_SIDED|90.0|0.8817|1.1964|||ANOVA|Point estimates for the geometric means ratios children/adults for Cmax normalized by dose and body weight and 90% CIs have been calculated.||An ANOVA for log-transformed values has been used as the basis for calculation of point estimates and Confidence Intervals (CIs).||1.1964|0.8817|
70998006|NCT00961441|141503498|SUPERIORITY_OR_OTHER||Point estimate for ratio|0.9914|||||TWO_SIDED|90.0|0.811|1.2118|||ANOVA|Point estimates for the geometric means ratios children/adults for AUCtau normalized by dose and body weight and 90% CIs have been calculated.||An ANOVA for log-transformed values has been used as the basis for calculation of point estimates and Confidence Intervals (CIs).||1.2118|0.8110|
70998007|NCT00835003|141503510|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations estimated a sample size of 1272 women with an estimated proportion of 8% in the 39 weeks Group and 14% in the 38 weeks group|Risk Ratio (RR)|0.86||||0.31|TWO_SIDED|95.0|0.65|1.15|||Chi-squared|||||1.15|0.65|0.31
70998008|NCT04446299|141503527|NON_INFERIORITY|The predetermined non-inferiority margin was 10%.|Risk Difference (RD)|3.42|||<|0.001|TWO_SIDED|95.0|-1.68|8.52|||Mantel Haenszel|||||8.52|-1.68|<0.001
70998009|NCT01148693|141503541|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||Null hypothesis: Adding gentamicin to contrast medium during ERCP has no relation with postERCP cholangitis Power calculation: 80%||||<0.05
71041193|NCT02250651|141590791|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.38||0.2304|TWO_SIDED|95.0|-1.22|0.29|||MMRM|||Change from Baseline at Week 6, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.29|-1.22|0.2304
71041194|NCT02250651|141590791|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.38||0.1272|TWO_SIDED|95.0|-1.34|0.17|||MMRM|||Change from Baseline at Week 6, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.17|-1.34|0.1272
71041195|NCT02250651|141590791|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.36||0.0038|TWO_SIDED|95.0|-1.76|-0.34|||MMRM|||Change from Baseline at Week 6, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.34|-1.76|0.0038
71041196|NCT02250651|141590791|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.36||0.0741|TWO_SIDED|95.0|-1.36|0.06|||MMRM|||Change from Baseline at Week 6, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.06|-1.36|0.0741
71041197|NCT03496298|141590792|NON_INFERIORITY|Non-inferiority of efpeglenatide 4 mg+6 mg versus placebo was to be claimed if the upper bound of the 2-sided 95% CI of the hazard ratio for the incidence of both 1.8 and less and 1.3 or less.|Hazard Ratio (HR)|0.732|||<|0.0001|TWO_SIDED|95.0|0.583|0.918||One-sided p-value based on log rank test of hazard ratio for the incidence of both 1.8 and less and 1.3 or less.|Log Rank|||Hazard ratio and 95% Confidence Interval (CI) were obtained from a Cox proportional hazards model with region (North America, Latin America, Europe, other), randomization stratum of SGLT2 inhibitor use (current use, potential future use, neither current nor potential future use) and treatment (efpeglenatide 4 mg, efpeglenatide 6 mg, placebo) as fixed effect factor.||0.918|0.583|<.0001
71041198|NCT03496298|141590793|SUPERIORITY|Superiority was claimed when the upper bound of the 2-sided 95% CI of hazard ratio was less than 1.|Hazard Ratio (HR)|0.732||||0.0069|TWO_SIDED|95.0|0.583|0.918||Two-sided p-values based on log rank test of hazard ratio.|Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model with region (North America, Latin America, Europe, other), randomization stratum of SGLT2 inhibitor use (current use, potential future use, neither current nor potential future use) and treatment (efpeglenatide 4 mg, efpeglenatide 6 mg, placebo) as fixed effect factor.||0.918|0.583|0.0069
71041199|NCT03496298|141590794|SUPERIORITY|Superiority was claimed when the upper bound of the 2-sided 95% CI of hazard ratio was less than 1.|Hazard Ratio (HR)|0.79||||0.02|TWO_SIDED|95.0|0.65|0.96||Two-sided p-values based on log rank test of hazard ratio.|Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model with region (North America, Latin America, Europe, other), randomization stratum of SGLT2 inhibitor use (current use, potential future use, neither current nor potential future use) and treatment (efpeglenatide 4 mg, efpeglenatide 6 mg, placebo) as fixed effect factor.||0.96|0.65|0.02
71041200|NCT03496298|141590795|SUPERIORITY|Superiority was claimed when the upper bound of the 2-sided 95% CI of hazard ratio was less than 1.|Hazard Ratio (HR)|0.675|||<|0.0001|TWO_SIDED|95.0|0.574|0.794||Two-sided p-values based on log rank test of hazard ratio.|Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model with region (North America, Latin America, Europe, other), randomization stratum of SGLT2 inhibitor use (current use, potential future use, neither current nor potential future use) and treatment (efpeglenatide 4 mg, efpeglenatide 6 mg, placebo) as fixed effect factor.||0.794|0.574|<.0001
71041201|NCT01658995|141590796|SUPERIORITY||Risk Difference (RD)|-9.9||||0.37|TWO_SIDED|95.0|-31.4|11.6|||Chi-squared|||||11.6|-31.4|0.37
71041202|NCT01658995|141590797|SUPERIORITY|||||||0.46|||||||Chi-squared|||||||0.46
71041203|NCT02418754|141590867|SUPERIORITY|Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurements as covariate and treatment group, baseline angiographic choroidal neovascularization (CNV) subtype (predominantly or minimally classic versus occult versus occult with no classic lesions) as fixed factors.|Least Squares (LS) Mean Difference|-1.58||||0.2052|TWO_SIDED|95.0|-4.37|1.22||Threshold for significance at 0.025 level.|ANCOVA|||To control for the family-wise type I error rate of 5%, for each of the 2 REGN2176-3 groups the 2-sided hypothesis comparing REGN2176-3 (1 mg: 2 mg) vs. Intravitreal Aflibercept Injection (IAI) 2 mg was tested at a significance level of α = 2.5%.||1.22|-4.37|0.2052
71041204|NCT02418754|141590867|SUPERIORITY|Analysis was performed using ANCOVA model with baseline measurements as covariate and treatment group, baseline angiographic choroidal neovascularization (CNV) subtype (predominantly or minimally classic versus occult versus occult with no classic lesions) as fixed factors.|Least Squares (LS) Mean Difference|-1.7||||0.0982|TWO_SIDED|95.0|-4.0|0.61||Threshold for significance at 0.025 level.|ANCOVA|||To control for the family-wise type I error rate of 5%, for each of the 2 REGN2176-3 groups the 2-sided hypothesis comparing REGN2176-3 (1 mg: 2 mg) vs. Intravitreal Aflibercept Injection (IAI) 2 mg was tested at a significance level of α = 2.5%.||0.61|-4.00|0.0982
70923848|NCT03703700|141339526|OTHER|||||||0.417|||||||Wilcoxon (Mann-Whitney)|||Twin||||0.417
70998010|NCT04024072|141503549|EQUIVALENCE|8AM Day 14|Mean Difference (Net)|-0.46|||||TWO_SIDED|95.0|-0.93|0.01||||||||0.01|-0.93|
70998011|NCT04024072|141503549|EQUIVALENCE|10AM Day 14|Mean Difference (Net)|-0.23|||||TWO_SIDED|95.0|-0.7|0.24||||||||0.24|-0.70|
70998012|NCT04024072|141503549|EQUIVALENCE|8AM Day 42|Mean Difference (Net)|-0.24|||||TWO_SIDED|95.0|-0.74|0.27||||||||0.27|-0.74|
70998013|NCT04024072|141503549|EQUIVALENCE|10AM Day 42|Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.51|0.51||||||||0.51|-0.51|
70998014|NCT00091962|141503584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001||||0.001|TWO_SIDED|95.0||||repeated measures mixed-effect model with treatment, time (4 time points), and sex; all 2- and 3-factor interaction terms with subject intercepts were treated as a random effect to account for individual differences at randomization.|Mixed Models Analysis|||||||0.001
70998015|NCT01488409|141503587|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||t-test, 2 sided|||||||0.97
70998016|NCT01488409|141503588|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED||||||t-test, 2 sided|||||||0.85
70998017|NCT01488409|141503589|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||t-test, 2 sided|||||||0.52
70998018|NCT01488409|141503590|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||t-test, 2 sided|||||||0.79
70998019|NCT01488409|141503591|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||t-test, 2 sided|||||||0.007
70998020|NCT00587834|141503592|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Exact Bionomial Test|||Superiority relative to a pre-defined standard (50% success)||||<0.0001
70998021|NCT00587834|141503593|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||McNemar|||Compare participants with (1) Gintuit equally red and Control not equally red to (2) Gintuit not equally red and Control equally red||||<0.0001
70998022|NCT00587834|141503594|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||McNemar|||Compare participants with (1)Gintuit equally firm and Control not equally firm to (2) Gintuit not equally firm and Control equally firm||||<0.0001
70998023|NCT00587834|141503595|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Exact binomial test|||Superiority relative to a pre-defined threshold (80%) success||||<0.0001
70998024|NCT00587834|141503596|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Exact binomial test|||The proportion of Gintuit as the preferred procedure.||||<0.0001
70998025|NCT00587834|141503597|SUPERIORITY_OR_OTHER|||||||0.3173||95.0|||||McNemar|McNemar's paired comparison test||Compare participants with (1) Gintuit not sensitive and Control sensitive to (2) Gintuit sensitive and Control not sensitive.||||0.3173
70998026|NCT00862654|141503637|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Each test was two-sided, at the 0.050 significance level.||The primary efficacy criterion was analyzed by using the Cochran-Mantel-Haenszel (CMH) statistic, stratified by center (or analysis-center) after ridit transformation with the row mean difference statistics, testing the hypothesis of equality. The p-value had to be inferior to 0.05 at week 4, in the ITT/LOCF population. PP analysis was also performed to assess the robustness of the results obtained in the ITT/LOCF population.||||<0.01
70998027|NCT00862654|141503637|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||95.0|||||Cochran-Mantel-Haenszel|Each test was two-sided, at the 0.050 significance level.||The primary efficacy criterion was analyzed by using the Cochran-Mantel-Haenszel (CMH) statistic, stratified by center (or analysis-center) after ridit transformation with the row mean difference statistics, testing the hypothesis of equality. The p-value had to be inferior to 0.05 at week 4, in the ITT/LOCF population. PP analysis was also performed to assess the robustness of the results obtained in the ITT/LOCF population.||||0.039
70998028|NCT03219567|141503657|OTHER|||||||0.35|||||||t-test, 2 sided|||OCT compared to MRI||||0.35
70998029|NCT01313208|141503661|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.055|TWO_SIDED|95.0|0.99|3.41|||Mantel Haenszel|P-value from Mantel-Haenszel test stratified by participant's baseline methotrexate use (yes or no).|Etanercept/Placebo|||3.41|0.99|0.055
70998030|NCT01654523|141503703|SUPERIORITY_OR_OTHER||Mean change in the single arm trial|6.695|STANDARD_DEVIATION|5.505|<|0.05|TWO_SIDED|95.0|4.041|9.348|||Paired t-test|||||9.348|4.041|<0.05
70998031|NCT03954444|141503710|EQUIVALENCE|90% Confidence Interval, should be within -20% to +20%|Mean Difference (Net)|2.7|||||TWO_SIDED|90.0|-2.6|8.0||||||||8.0|-2.6|
70998032|NCT03954444|141503710|SUPERIORITY|||||||0.04|||||||Cochran-Mantel-Haenszel|||||||0.04
70998033|NCT03954444|141503710|SUPERIORITY|||||||0.1126|||||||Cochran-Mantel-Haenszel|||||||0.1126
70998034|NCT00435994|141503751|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANOVA|||||||0.0020
70998035|NCT00435994|141503752|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANOVA|||||||.0020
70998036|NCT02472795|141503768|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.2||0.39|TWO_SIDED|95.0|-0.56|0.22|||ANCOVA|||||0.22|-0.56|0.39
70998037|NCT02472795|141503768|SUPERIORITY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.02|TWO_SIDED|95.0|-0.91|0.09|||ANCOVA|||||0.09|-0.91|0.02
70998038|NCT02472795|141503768|SUPERIORITY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.19||0.004|TWO_SIDED|95.0|-0.95|-0.19|||ANCOVA|||||-0.19|-0.95|0.004
70998039|NCT02472795|141503768|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.19||0.06|TWO_SIDED|95.0|-0.75|0.02|||ANCOVA|||||0.02|-0.75|0.06
70998040|NCT02472795|141503770|SUPERIORITY||Mean Difference (Final Values)|-0.145|STANDARD_ERROR_OF_MEAN|0.134||0.2837|TWO_SIDED|95.0|-0.413|0.123|||ANCOVA|||||0.123|-0.413|0.2837
70998041|NCT02472795|141503770|SUPERIORITY||Mean Difference (Final Values)|-0.515|STANDARD_ERROR_OF_MEAN|0.14||0.0006|TWO_SIDED|95.0|-0.797|-0.234|||ANCOVA|||||-0.234|-0.797|0.0006
70998042|NCT02472795|141503770|SUPERIORITY||Mean Difference (Final Values)|-0.565|STANDARD_ERROR_OF_MEAN|0.13||0.0001|TWO_SIDED|95.0|-0.825|-0.305|||ANCOVA|||||-0.305|-0.825|0.0001
70998043|NCT02472795|141503770|SUPERIORITY||Mean Difference (Final Values)|-0.88|STANDARD_ERROR_OF_MEAN|0.147|<|0.0001|TWO_SIDED|95.0|-1.173|-0.586|||ANCOVA|||||-0.586|-1.173|<0.0001
70998044|NCT02472795|141503772|SUPERIORITY||Mean Difference (Final Values)|-13.214|STANDARD_ERROR_OF_MEAN|9.626||0.1755|TWO_SIDED|95.0|-32.513|6.085|||ANCOVA|||||6.085|-32.513|0.1755
70998045|NCT02472795|141503772|SUPERIORITY||Mean Difference (Final Values)|-39.311|STANDARD_ERROR_OF_MEAN|10.096||0.0003|TWO_SIDED|95.0|-59.552|-19.069|||ANCOVA|||||-19.069|-59.552|0.0003
70998046|NCT02472795|141503772|SUPERIORITY||Mean Difference (Final Values)|-47.278|STANDARD_ERROR_OF_MEAN|9.329|<|0.0001|TWO_SIDED|95.0|-65.981|-28.574|||ANCOVA|||||-28.574|-65.981|<0.0001
70998047|NCT02472795|141503772|SUPERIORITY||Mean Difference (Final Values)|-56.452|STANDARD_ERROR_OF_MEAN|10.541|<|0.0001|TWO_SIDED|95.0|-77.585|-35.32|||ANCOVA|||||-35.320|-77.585|<0.0001
70998048|NCT05109702|141503773|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.094||0.764|TWO_SIDED|95.0|-0.214|0.157|||MMRM|||The Least Square (LS) means, LS mean difference, Standard Errors (SEs), two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the Mixed model repeated measures (MMRM) model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.157|-0.214|0.764
70998049|NCT05109702|141503774|SUPERIORITY||LS Mean Difference|4.34|STANDARD_ERROR_OF_MEAN|2.969||0.144|TWO_SIDED|95.0|-1.483|10.155|||MMRM|||The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||10.155|-1.483|0.144
70998050|NCT05109702|141503775|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.094||0.056|TWO_SIDED|95.0|-0.005|0.363|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.363|-0.005|0.056
70998051|NCT05109702|141503775|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.094||0.064|TWO_SIDED|95.0|-0.01|0.359|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.359|-0.010|0.064
70998052|NCT05109702|141503775|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.095||0.328|TWO_SIDED|95.0|-0.093|0.279|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.279|-0.093|0.328
70998053|NCT05109702|141503775|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.096||0.837|TWO_SIDED|95.0|-0.208|0.168|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.168|-0.208|0.837
70998054|NCT05109702|141503776|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.079||0.686|TWO_SIDED|95.0|-0.123|0.187|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.187|-0.123|0.686
70998055|NCT05109702|141503776|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.079||0.68|TWO_SIDED|95.0|-0.123|0.188|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.188|-0.123|0.680
70998056|NCT05109702|141503776|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.08||0.529|TWO_SIDED|95.0|-0.107|0.207|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.207|-0.107|0.529
71041205|NCT01493596|141590880|OTHER|Comparison of event rates across dose groups.|percentage|14.3|||||TWO_SIDED||||||||There were a total of 5 non-serious adverse events for an AE rate of 14.3%|Descriptive statistics for evaluation of AEs|Descriptive statistics of adverse events|||
70998057|NCT05109702|141503776|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.081||0.745|TWO_SIDED|95.0|-0.132|0.185|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.185|-0.132|0.745
71041206|NCT04784637|141590891|SUPERIORITY|||||||0.064|||||||t-test, 2 sided|||||||0.064
70923849|NCT03703700|141339527|OTHER|||||||0.985|||||||Wilcoxon (Mann-Whitney)|||Singleton||||0.985
71041207|NCT04784637|141590891|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
71041208|NCT04784637|141590892|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71041209|NCT04784637|141590892|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||||||0.93
70923850|NCT03703700|141339527|OTHER|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||Twin||||0.157
71041210|NCT03259789|141590897|SUPERIORITY||Difference of LS Means|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.74|-0.32|||Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||||-0.32|-0.74|< 0.0001
70923851|NCT03703700|141339528|OTHER||Risk Ratio (RR)|1.07||||0.789|TWO_SIDED|95.0|0.65|1.78|||Chi-squared|||||1.78|0.65|0.789
70998058|NCT05109702|141503777|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.085||0.765|TWO_SIDED|95.0|-0.141|0.192|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.192|-0.141|0.765
70998059|NCT05109702|141503777|SUPERIORITY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.085||0.053|TWO_SIDED|95.0|-0.002|0.331|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.331|-0.002|0.053
70998060|NCT05109702|141503777|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.086||0.552|TWO_SIDED|95.0|-0.117|0.219|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.219|-0.117|0.552
70998061|NCT05109702|141503777|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.087||0.593|TWO_SIDED|95.0|-0.216|0.124|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.124|-0.216|0.593
70998062|NCT05109702|141503778|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.087||0.884|TWO_SIDED|95.0|-0.183|0.158|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.158|-0.183|0.884
70998063|NCT05109702|141503778|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.087||0.474|TWO_SIDED|95.0|-0.109|0.233|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.233|-0.109|0.474
70998064|NCT05109702|141503778|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.088||0.202|TWO_SIDED|95.0|-0.06|0.285|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.285|-0.060|0.202
70998065|NCT05109702|141503778|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.089||0.013|TWO_SIDED|95.0|0.047|0.396|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.396|0.047|0.013
70998066|NCT05109702|141503779|OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.09||0.604|TWO_SIDED|95.0|-0.131|0.224|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.224|-0.131|0.604
70998067|NCT05109702|141503779|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.091||0.519|TWO_SIDED|95.0|-0.119|0.236|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.236|-0.119|0.519
70998068|NCT05109702|141503779|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.092||0.299|TWO_SIDED|95.0|-0.085|0.275|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.275|-0.085|0.299
70998069|NCT05109702|141503779|SUPERIORITY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.093||0.124|TWO_SIDED|95.0|-0.039|0.324|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.324|-0.039|0.124
71041211|NCT03259789|141590899|SUPERIORITY||Difference of LS Means|-1.35|||<|0.0001|TWO_SIDED|95.0|-1.83|-0.86|||Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||||-0.86|-1.83|< 0.0001
71041212|NCT03259789|141590901|SUPERIORITY||Difference of LS Means|-7.07|||<|0.0001|TWO_SIDED|95.0|-9.83|-4.32|||Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||||-4.32|-9.83|< 0.0001
71041213|NCT03259789|141590902|SUPERIORITY||Odds Ratio (OR)|4.69||||0.0014|TWO_SIDED|95.0|1.7|12.95||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates|The odds ratios of bexagliflozin group over the placebo group at each visit will be estimated from LS means based on the model with the corresponding p-values and their two-sided 95% CIs presented.|Odds ratio at Week 6 was calculated as the odds ratio of bexagliflozin group over placebo group.||12.95|1.70|0.0014
71041214|NCT03259789|141590902|SUPERIORITY||Odds Ratio (OR)|4.18||||0.0001|TWO_SIDED|95.0|1.96|8.92||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates|The odds ratios of bexagliflozin group over the placebo group at each visit will be estimated from LS means based on the model with the corresponding p-values and their two-sided 95% CIs presented.|Odds ratio at Week 12 was calculated as the odds ratio of bexagliflozin group over placebo group.||8.92|1.96|0.0001
71041215|NCT03259789|141590902|SUPERIORITY||Odds Ratio (OR)|2.57||||0.003|TWO_SIDED|95.0|1.31|5.04||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates|The odds ratios of bexagliflozin group over the placebo group at each visit will be estimated from LS means based on the model with the corresponding p-values and their two-sided 95% CIs presented.|Odds ratio at Week 18 was calculated as the odds ratio of bexagliflozin group over placebo group.||5.04|1.31|0.0030
70998070|NCT05109702|141503780|SUPERIORITY||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.215||0.293|TWO_SIDED|95.0|-0.196|0.647|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.647|-0.196|0.293
70998071|NCT05109702|141503780|SUPERIORITY||LS Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.215||0.094|TWO_SIDED|95.0|-0.062|0.783|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.783|-0.062|0.094
71041216|NCT03259789|141590902|SUPERIORITY||Odds Ratio (OR)|3.88|||<|0.0001|TWO_SIDED|95.0|1.99|7.58||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates|The odds ratios of bexagliflozin group over the placebo group at each visit will be estimated from LS means based on the model with the corresponding p-values and their two-sided 95% CIs presented.|Odds ratio at Week 24 was calculated as the odds ratio of bexagliflozin group over placebo group.||7.58|1.99|< 0.0001
71041217|NCT03259789|141590904|SUPERIORITY||Difference of LS Means|-2.51|||<|0.0001|TWO_SIDED|95.0|-3.45|-1.57|||ANCOVA|ANCOVA analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||||-1.57|-3.45|< 0.0001
71041218|NCT03259789|141590906|SUPERIORITY||Difference of LS Means|-0.56|||<|0.0001|TWO_SIDED|95.0|-0.74|-0.38||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||Model-adjusted change from baseline at week 6 was calculated as the difference in LS Mean between bexagliflozin group and placebo group.||-0.38|-0.74|< 0.0001
71041219|NCT03259789|141590906|SUPERIORITY||Difference of LS Means|-0.66|||<|0.0001|TWO_SIDED|95.0|-0.86|-0.46||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||Model-adjusted change from baseline at week 12 was calculated as the difference in LS Mean between bexagliflozin group and placebo group.||-0.46|-0.86|< 0.0001
71041220|NCT03259789|141590906|SUPERIORITY||Difference of LS Means|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.69|-0.3||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||Model-adjusted change from baseline at week 18 was calculated as the difference in LS Mean between bexagliflozin group and placebo group.||-0.30|-0.69|< 0.0001
71041221|NCT03259789|141590906|SUPERIORITY||Difference of LS Means|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.74|-0.32||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||Model-adjusted change from baseline at week 24 was calculated as the difference in LS Mean between bexagliflozin group and placebo group.||-0.32|-0.74|< 0.0001
71041222|NCT02416934|141590927|SUPERIORITY||Mean Difference (Final Values)|-1.5392|STANDARD_ERROR_OF_MEAN|0.7176||0.036|TWO_SIDED|95.0|-2.9761|-0.1022|||t-test, 2 sided|||Comparing DSQ between Dexamethasone and Saline at Day 1 post-op||-.1022|-2.9761|0.036
71041223|NCT02416934|141590927|SUPERIORITY||Mean Difference (Final Values)|-0.604|STANDARD_ERROR_OF_MEAN|0.2543|<|0.05|TWO_SIDED|95.0|-1.1151|-0.093|||t-test, 2 sided|||Comparing Bazaz between Dexamethasone and Saline at 6 months post-op||-.0930|-1.1151|<.05
70998072|NCT05109702|141503780|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.217||0.404|TWO_SIDED|95.0|-0.245|0.608|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.608|-0.245|0.404
70998073|NCT05109702|141503780|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.22||0.806|TWO_SIDED|95.0|-0.485|0.377|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.377|-0.485|0.806
70998074|NCT05109702|141503781|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.157||0.824|TWO_SIDED|95.0|-0.273|0.343|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.343|-0.273|0.824
70998075|NCT05109702|141503781|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.157||0.437|TWO_SIDED|95.0|-0.186|0.431|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.431|-0.186|0.437
70998076|NCT05109702|141503781|SUPERIORITY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.159||0.193|TWO_SIDED|95.0|-0.105|0.519|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.519|-0.105|0.193
70998077|NCT05109702|141503781|SUPERIORITY||LS Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.161||0.024|TWO_SIDED|95.0|0.048|0.679|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.679|0.048|0.024
70998078|NCT05109702|141503782|SUPERIORITY||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.329||0.43|TWO_SIDED|95.0|-0.386|0.907|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.907|-0.386|0.430
70998079|NCT05109702|141503782|SUPERIORITY||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.33||0.143|TWO_SIDED|95.0|-0.164|1.132|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||1.132|-0.164|0.143
70998080|NCT05109702|141503782|SUPERIORITY||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.333||0.245|TWO_SIDED|95.0|-0.267|1.042|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||1.042|-0.267|0.245
70923852|NCT03703700|141339529|OTHER||Risk Ratio (RR)|1.09||||0.769|TWO_SIDED|95.0|0.61|1.94|||Chi-squared|||||1.94|0.61|0.769
71008552|NCT02055976|141525224|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.384|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-68.733|-54.035|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-54.035|-68.733|<0.001
71008553|NCT02055976|141525224|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-47.578|STANDARD_ERROR_OF_MEAN|4.273|<|0.001|TWO_SIDED|95.0|-56.067|-39.088|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-39.088|-56.067|<0.001
71008554|NCT02055976|141525224|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-63.346|STANDARD_ERROR_OF_MEAN|4.244|<|0.001|TWO_SIDED|95.0|-71.776|-54.915|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-54.915|-71.776|<0.001
71008555|NCT02055976|141525224|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-66.691|STANDARD_ERROR_OF_MEAN|4.226|<|0.001|TWO_SIDED|95.0|-75.088|-58.295|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-58.295|-75.088|<0.001
70923853|NCT03703700|141339530|OTHER||Risk Ratio (RR)|0.41||||0.59|TWO_SIDED|95.0|0.04|4.45|||Fisher Exact|||||4.45|0.04|0.590
71041224|NCT02416934|141590928|SUPERIORITY||Mean Difference (Final Values)|1.7874|STANDARD_ERROR_OF_MEAN|3.1273|<|0.05|TWO_SIDED|95.0|-4.5153|8.0902|||t-test, 2 sided|||Comparing the changes in VNDI between Dexamethasone and Saline from baseline to last visit||8.0902|-4.5153|<.05
71041225|NCT02416934|141590929|SUPERIORITY|||||||0.375||||||Fisher's Exact Test|Fisher Exact|||||||.375
71041226|NCT00127166|141590966|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-3.25||||0.009||95.0|-5.66|-0.84|||ANOVA|Model terms: participant, treatment and period. The treatment test is adjusted for period||||-0.84|-5.66|0.009
71041227|NCT00127166|141590967|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-52.71||||0.006||95.0|-89.76|-15.66|||ANOVA|Model terms: participant, treatment and period. The treatment test is adjusted for period.||||-15.66|-89.76|0.006
71041228|NCT00127166|141590968|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.11|||<|0.001||95.0|2.58|5.64|||ANCOVA|Participant, treatment, period \& covariate for FEV1 %-predicted Treatment test is adjusted for period \& FEV1 %-predicted at pre-exercise baseline||||5.64|2.58|<0.001
71041229|NCT00127166|141590969|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.26||||0.035||95.0|1.02|1.55|||Cox Proportional Hazards Model|Model terms: treatment and period|Dispersion not applicable to time to event data|||1.55|1.02|0.035
71041230|NCT00127166|141590970|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|3.8|||<|0.001||95.0|2.28|5.32|||ANOVA|Model terms: participant, treatment and period. The treatment test is adjusted for period.||||5.32|2.28|<0.001
71041231|NCT00393705|141591062|SUPERIORITY_OR_OTHER|||||||0.2519||95.0|||||ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.2519
71041232|NCT00393705|141591063|SUPERIORITY_OR_OTHER|||||||0.0287||95.0||||P-value for HbA1c \<7%. Additional statistically significant terms from the model below were baseline HbA1c and treatment by lead-in interaction.|Regression, Logistic|Model: Logit(p(response)/1-p(response)) = U + r' X, where u = intercept parameter, X = vector of parameters (treatment, baseline value, lead-in).||||||0.0287
71041233|NCT00393705|141591063|SUPERIORITY_OR_OTHER|||||||0.0471||95.0||||P-value for HbA1c ≤6.5%. Additional statistically significant term from the model below was baseline HbA1c.|Regression, Logistic|Model: Logit(p(response)/1-p(response)) = U + r' X, where u = intercept parameter, X = vector of parameters (treatment, baseline value, lead-in).||||||0.0471
71041234|NCT00393705|141591065|SUPERIORITY_OR_OTHER|||||||0.0077||95.0|||||ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0077
71041235|NCT00393705|141591066|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0002
71041236|NCT00393705|141591067|SUPERIORITY_OR_OTHER|||||||0.0129||95.0||||P-value for Fasting.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0129
71041237|NCT00393705|141591067|SUPERIORITY_OR_OTHER|||||||0.0027||95.0||||P-value for 2-Hours After Breakfast.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0027
71041238|NCT00393705|141591067|SUPERIORITY_OR_OTHER|||||||0.1947||95.0||||P-value for Pre-Lunch.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.1947
71041239|NCT00393705|141591067|SUPERIORITY_OR_OTHER|||||||0.0077||95.0||||P-value for 2-Hours After Lunch.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0077
71041240|NCT00393705|141591067|SUPERIORITY_OR_OTHER|||||||0.1885||95.0||||P-value for Pre-Dinner.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.1885
71041241|NCT00393705|141591067|SUPERIORITY_OR_OTHER|||||||0.5525||95.0||||P-value for 2-Hours After Dinner.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.5525
71041242|NCT00393705|141591067|SUPERIORITY_OR_OTHER|||||||0.4994||95.0||||P-value for 3:00 A.M.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.4994
71041243|NCT00393705|141591069|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||P-value for Total Hypoglycemic Episodes/30 Days.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.7230
71041244|NCT00393705|141591069|SUPERIORITY_OR_OTHER|||||||0.0063||95.0||||P-value for Nocturnal Hypoglycemic Episodes/30 Days.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0063
71041245|NCT00393705|141591069|SUPERIORITY_OR_OTHER|||||||0.8876||95.0||||P-value for Severe Hypoglycemic Episodes/30 Days.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.8876
71041246|NCT00393705|141591070|SUPERIORITY_OR_OTHER|||||||0.0009||95.0|||||ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0009
71041247|NCT00393705|141591071|SUPERIORITY_OR_OTHER|||||||0.0056||95.0||||P-value for Week 4|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0056
71041248|NCT00393705|141591071|SUPERIORITY_OR_OTHER|||||||0.0421||95.0||||P-value for Week 12|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0421
71041249|NCT01475487|141591100|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 21 participants per group was required to detect a 40% absolute difference in the complication rate between DP and US guided techniques assuming a 45% complication rate in the DP (control) group and using the Fisher's exact test for the comparison of independent proportions. A total of 23 and 24 participants were recruited in the DP and US group, respectively.|||||<|0.01|TWO_SIDED||||||Fisher Exact|||||||<0.01
71041250|NCT01475487|141591101|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.88||||0.001|TWO_SIDED|95.0|1.39|5.94|||Fisher Exact||Risk of injury ( none-mild vs moderate -severe) for all participants|||5.94|1.39|0.001
71041251|NCT01475487|141591101|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Grade 3-4 comparison of None-mild and moderate-severe||||<0.001
71041252|NCT01475487|141591102|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.91||||0.701|TWO_SIDED|95.0|0.12|2.72|||Fisher Exact||This is the risk ratio for 1 vs 2 attempts|||2.72|0.12|0.701
71041253|NCT01475487|141591103|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|5.6||||0.043|TWO_SIDED|95.0|0.79|39.48|||Fisher Exact|||Comparison for Grade 3-4||39.48|0.79|0.043
70998081|NCT05109702|141503782|SUPERIORITY||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.337||0.359|TWO_SIDED|95.0|-0.352|0.97|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.970|-0.352|0.359
70998082|NCT05109702|141503783|SUPERIORITY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.067||0.016|TWO_SIDED|95.0|0.03|0.292|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.292|0.030|0.016
70998083|NCT05109702|141503783|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.067||0.099|TWO_SIDED|95.0|-0.021|0.242|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.242|-0.021|0.099
70998084|NCT05109702|141503783|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.068||0.493|TWO_SIDED|95.0|-0.086|0.179|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.179|-0.086|0.493
70998085|NCT05109702|141503783|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.068||0.987|TWO_SIDED|95.0|-0.133|0.135|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.135|-0.133|0.987
70998086|NCT05109702|141503784|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.072||0.655|TWO_SIDED|95.0|-0.109|0.173|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.173|-0.109|0.655
70998087|NCT05109702|141503784|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.072||0.826|TWO_SIDED|95.0|-0.157|0.125|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.125|-0.157|0.826
70998088|NCT05109702|141503784|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.073||0.861|TWO_SIDED|95.0|-0.155|0.13|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.130|-0.155|0.861
71041254|NCT03203642|141591104|SUPERIORITY||LS mean difference|-0.0052|STANDARD_ERROR_OF_MEAN|0.0082||0.5265|TWO_SIDED|95.0|-0.0217|||Threshold for significance at 0.05 level.|ANCOVA|||An ANCOVA model included treatment group as a factor and the Baseline htTKV (log10 transformed) as a covariate for the analysis. The outcome measure was tested at 2-sided 0.05 level to control Type I error rate.||- 0.0112|-0.0217|0.5265
71041255|NCT03203642|141591105|SUPERIORITY||LS mean difference|-0.0042|STANDARD_ERROR_OF_MEAN|0.0111||0.7076|TWO_SIDED|95.0|-0.0264|||Threshold for significance at 0.05 level.|ANCOVA|||An ANCOVA model included treatment group as a factor and the Baseline htTKV (log10 transformed) as a covariate for the analysis. The outcome measure was tested at 2-sided 0.05 level to control Type I error rate.||- 0.0180|-0.0264|0.7076
71041256|NCT03203642|141591106|SUPERIORITY||LS mean difference|-0.0122|STANDARD_ERROR_OF_MEAN|0.014||0.3895|TWO_SIDED|95.0|-0.0404|||Threshold for significance at 0.05 level.|ANCOVA|||An ANCOVA model included treatment group as a factor and the Baseline htTKV (log10 transformed) as a covariate for the analysis. The outcome measure was tested at 2-sided 0.05 level to control Type I error rate.||- 0.0160|-0.0404|0.3895
70998089|NCT05109702|141503784|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.073||0.556|TWO_SIDED|95.0|-0.101|0.187|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.187|-0.101|0.556
70998090|NCT05109702|141503785|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.087||0.527|TWO_SIDED|95.0|-0.116|0.226|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.226|-0.116|0.527
70998091|NCT05109702|141503785|SUPERIORITY||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.087||0.005|TWO_SIDED|95.0|0.077|0.418|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.418|0.077|0.005
70998092|NCT05109702|141503785|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.088||0.92|TWO_SIDED|95.0|-0.164|0.181|||MMRM|||Wek 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.181|-0.164|0.920
70998093|NCT05109702|141503785|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.089||0.286|TWO_SIDED|95.0|-0.08|0.269|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.269|-0.080|0.286
70998094|NCT05109702|141503786|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.098||0.071|TWO_SIDED|95.0|-0.015|0.369|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.369|-0.015|0.071
70998095|NCT05109702|141503786|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.098||0.384|TWO_SIDED|95.0|-0.107|0.278|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.278|-0.107|0.384
70998096|NCT05109702|141503786|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.099||0.391|TWO_SIDED|95.0|-0.109|0.28|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.280|-0.109|0.391
70998097|NCT05109702|141503786|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.1||0.802|TWO_SIDED|95.0|-0.171|0.222|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.222|-0.171|0.802
70998098|NCT05109702|141503787|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.098||0.884|TWO_SIDED|95.0|-0.206|0.178|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.178|-0.206|0.884
71041257|NCT03203642|141591107|SUPERIORITY||LS mean difference|0.0015|STANDARD_ERROR_OF_MEAN|0.0131||0.9093|TWO_SIDED|95.0|-0.0248|||Threshold for significance at 0.05 level.|ANCOVA|||An ANCOVA model included treatment group as a factor and the Baseline htTKV (log10 transformed) as a covariate for the analysis. The outcome measure was tested at 2-sided 0.05 level to control Type I error rate.||- 0.0278|-0.0248|0.9093
71041258|NCT01958060|141591155|SUPERIORITY_OR_OTHER||Slope|1.0604|STANDARD_ERROR_OF_MEAN|0.0337|||TWO_SIDED|95.0|0.9901|1.1308|||||Dose proportionality was explored using linear regression model (ANOVA).The perfect dose proportionality would correspond to a slope β of 1.PK endpoints on the log-transformed scale.Standard error (SE) of the mean is actually the SE of the slope.|This was non confirmatory testing (Single dose). Dose proportionality of BI 1034020 following iv administration of single rising doses of 5 mg, 10 mg, 20 mg and 50 mg for Cmax was analysed.||1.1308|0.9901|
70998099|NCT05109702|141503787|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.098||0.303|TWO_SIDED|95.0|-0.091|0.293|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.293|-0.091|0.303
70998100|NCT05109702|141503787|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.099||0.554|TWO_SIDED|95.0|-0.135|0.253|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.253|-0.135|0.554
71041259|NCT01958060|141591157|SUPERIORITY_OR_OTHER||Slope|1.5629|STANDARD_ERROR_OF_MEAN|0.1056|||TWO_SIDED|95.0|1.3426|1.7833|||||Dose proportionality was explored using the linear regression model.The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.Standard error of the mean is actually the standard error of the slope.|This was non confirmatory testing (Single dose). Dose proportionality of BI 1034020 following iv administration of single rising doses of 5 mg, 10 mg, 20 mg and 50 mg for AUClast was analysed.||1.7833|1.3426|
71041260|NCT02293460|141591179|SUPERIORITY|The response rate was tested against the historical response rate of 33.3%.|Responder rate|76.2|||<|0.0001|TWO_SIDED|95.0|60.5|87.9||One-sided test at nominal level of significance alpha = 2.5 %|exact binomial Clopper-Pearson|||"For this single-arm study, the response rate was tested against the historical response rate of 33.3% with a 1-sided Clopper-Pearson exact test at the nominal level of significance of 2.5% on the Full Analysis Set. The null and alternative hypotheses were as follows:~H0: pI10E \<= 33.3% H1: pI10E \> 33.3%"||87.9|60.5|<0.0001
71041261|NCT02304406|141591181|OTHER||Odds Ratio (OR)|1.85||||0.1304|TWO_SIDED|95.0|0.8|4.77|||Cochran-Mantel-Haenszel|||||4.77|0.80|0.1304
71041262|NCT02304406|141591182|OTHER|||||||0.6422|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.6422
71041263|NCT02304406|141591183|OTHER|||||||0.4524|||||||Cochran-Mantel-Haenszel|||||||0.4524
71041264|NCT02304406|141591184|OTHER|||||||0.901|||||||Cochran-Mantel-Haenszel|||||||0.9010
71041265|NCT02304406|141591185|OTHER|||||||0.9067|||||||Cochran-Mantel-Haenszel|||||||0.9067
71041266|NCT02304406|141591186|OTHER|||||||0.8785|||||||Cochran-Mantel-Haenszel|||||||0.8785
71041267|NCT02304406|141591187|OTHER|||||||0.9231|||||||Cochran-Mantel-Haenszel|||||||0.9231
71041268|NCT02304406|141591188|OTHER|||||||0.978|||||||Cochran-Mantel-Haenszel|||||||0.9780
71041269|NCT02304406|141591189|OTHER|||||||0.1144|||||||Cochran-Mantel-Haenszel|||||||0.1144
71041270|NCT02304406|141591190|OTHER|||||||0.0862|||||||Cochran-Mantel-Haenszel|||||||0.0862
71041271|NCT02304406|141591191|OTHER|||||||0.0294|||||||Cochran-Mantel-Haenszel|||||||0.0294
71041272|NCT02304406|141591192|OTHER|||||||0.6877|||||||Cochran-Mantel-Haenszel|||||||0.6877
71041273|NCT04284553|141591197|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.97|1.49|||||"The Odds Ratio compares having open encounter as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having an open encounter alert in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the trial and adjusting for provider-level clustering.||1.49|0.97|
71041274|NCT04284553|141591197|SUPERIORITY||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.83|1.59|||||"The OR compares between having boostering as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having boostering in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.||1.59|0.83|
71041275|NCT04284553|141591197|SUPERIORITY||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.61|1.16|||||"The OR compares between having cold-state priming as an intervention factor in the arm the patient's primary care providers were assigned to vs. all others not having cold-state priming in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.||1.16|0.61|
71041276|NCT04284553|141591197|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.88|1.64|||||"The OR compares between having simplification as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having simplification in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.||1.64|0.88|
71100262|NCT01887600|141709220|SUPERIORITY||Odds Ratio (OR)|34.74|||<|0.001|TWO_SIDED|95.0|20.48|58.93|||Cochran-Mantel-Haenszel||Please note Odds Ratio and CI are shown in percentages.|The Cochran-Mantel-Haenszel (CMH) test was adjusted by region, history of of cardiovascular, cerebrovascular or thromboembolic (CV) disease, baseline Hb and baseline estimated glomerular filtration rate (eGFR). Superiority of roxadustat versus placebo was to be declared if the lower bound of the two-sided 95% confidence interval of the CMH odds ratio was higher than 1.||58.93|20.48|<0.001
70998101|NCT05109702|141503787|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.1||0.051|TWO_SIDED|95.0|-0.001|0.391|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.391|-0.001|0.051
70998102|NCT05109702|141503788|SUPERIORITY||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.17||0.131|TWO_SIDED|95.0|-0.077|0.591|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.591|-0.077|0.131
70998103|NCT05109702|141503788|SUPERIORITY||LS Mean Difference|0.35|STANDARD_ERROR_OF_MEAN|0.171||0.04|TWO_SIDED|95.0|0.016|0.685|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.685|0.016|0.040
70998104|NCT05109702|141503788|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.172||0.767|TWO_SIDED|95.0|-0.287|0.389|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.389|-0.287|0.767
70998105|NCT05109702|141503788|SUPERIORITY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.174||0.41|TWO_SIDED|95.0|-0.198|0.485|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.485|-0.198|0.410
70998106|NCT05109702|141503789|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.17||0.324|TWO_SIDED|95.0|-0.166|0.501|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.501|-0.166|0.324
70998107|NCT05109702|141503789|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.17||0.262|TWO_SIDED|95.0|-0.143|0.525|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.525|-0.143|0.262
70998108|NCT05109702|141503789|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.172||0.391|TWO_SIDED|95.0|-0.19|0.485|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.485|-0.190|0.391
70998109|NCT05109702|141503789|SUPERIORITY||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.174||0.192|TWO_SIDED|95.0|-0.114|0.568|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.568|-0.114|0.192
70998110|NCT05109702|141503790|SUPERIORITY||LS Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.29||0.14|TWO_SIDED|95.0|-0.141|0.999|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.999|-0.141|0.140
70998111|NCT05109702|141503790|SUPERIORITY||LS Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.291||0.061|TWO_SIDED|95.0|-0.025|1.117|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||1.117|-0.025|0.061
70998112|NCT05109702|141503790|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.294||0.49|TWO_SIDED|95.0|-0.374|0.78|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.780|-0.374|0.490
70998113|NCT05109702|141503790|SUPERIORITY||LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.297||0.212|TWO_SIDED|95.0|-0.212|0.953|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.953|-0.212|0.212
70923854|NCT03703700|141339531|OTHER||Risk Ratio (RR)|2.04||||0.465|TWO_SIDED|95.0|0.4|10.39|||Fisher Exact|||||10.39|0.40|0.465
71041277|NCT04284553|141591197|SUPERIORITY||Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.52|0.98|||||"The OR compares between having sign-off approval as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having sign-off approval in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.||0.98|0.52|
71041278|NCT04284553|141591197|SUPERIORITY||Odds Ratio (OR)|1.21|||||TWO_SIDED|95.0|0.89|1.64|||||"The OR compares between having pre-commitment as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having pre-commitment in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.||1.64|0.89|
71041279|NCT04284553|141591197|SUPERIORITY||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.55|1.19|||||"The OR compares patients having risk framing as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having risk framing in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.||1.19|0.55|
71041280|NCT04284553|141591199|SUPERIORITY||Mean Difference (Final Values)|1.78|||||TWO_SIDED|95.0|-17.6|21.2|||||"The estimate compares having open encounter as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having open encounter in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||21.2|-17.6|
71041281|NCT04284553|141591199|SUPERIORITY||Mean Difference (Final Values)|-12.1|||||TWO_SIDED|95.0|-41.8|17.5|||||"The estimate compares having boostering as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having boostering in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||17.5|-41.8|
71041282|NCT04284553|141591199|SUPERIORITY||Mean Difference (Final Values)|39.5|||||TWO_SIDED|95.0|11.6|67.4|||||"The estimate compares having cold-state priming as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having cold-state priming in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||67.4|11.6|
71041283|NCT04284553|141591199|SUPERIORITY||Mean Difference (Final Values)|-1.74|||||TWO_SIDED|95.0|-30.4|26.9|||||"The estimate compares having simplification as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having simplification in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||26.9|-30.4|
71041284|NCT04284553|141591199|SUPERIORITY||Mean Difference (Final Values)|-10.1|||||TWO_SIDED|95.0|-37.6|17.4|||||"The estimate compares having sign-off approval as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having sign-off approval in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||17.4|-37.6|
70998114|NCT05109702|141503791|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.06||0.784|TWO_SIDED|95.0|-0.134|0.101|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.101|-0.134|0.784
70998115|NCT05109702|141503791|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.06||0.324|TWO_SIDED|95.0|-0.058|0.176|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.176|-0.058|0.324
70998116|NCT05109702|141503791|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.06||0.13|TWO_SIDED|95.0|-0.027|0.21|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.210|-0.027|0.130
70998117|NCT05109702|141503791|SUPERIORITY||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.061||0|TWO_SIDED|95.0|0.11|0.35|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.350|0.110|0.000
70998118|NCT05109702|141503792|SUPERIORITY||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.623||0.532|TWO_SIDED|95.0|-0.834|1.613|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||1.613|-0.834|0.532
70998119|NCT05109702|141503792|SUPERIORITY||LS Mean Difference|0.72|STANDARD_ERROR_OF_MEAN|0.63||0.252|TWO_SIDED|95.0|-0.515|1.959|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||1.959|-0.515|0.252
70998120|NCT05109702|141503792|SUPERIORITY||LS Mean Difference|1.98|STANDARD_ERROR_OF_MEAN|0.636||0.002|TWO_SIDED|95.0|0.732|3.231|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||3.231|0.732|0.002
70998121|NCT05109702|141503793|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.167||0.723|TWO_SIDED|95.0|-0.386|0.268|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.268|-0.386|0.723
70998122|NCT05109702|141503793|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.167||0.254|TWO_SIDED|95.0|-0.519|0.137|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.137|-0.519|0.254
71041285|NCT04284553|141591199|SUPERIORITY||Mean Difference (Final Values)|4.2|||||TWO_SIDED|95.0|-24.1|32.5|||||"The estimate compares having pre-commitment as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having pre-commitment in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||32.5|-24.1|
71041286|NCT04284553|141591199|SUPERIORITY||Mean Difference (Final Values)|-12.0|||||TWO_SIDED|95.0|-45.5|21.5|||||"The estimate compares having risk framing as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having risk framing in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||21.5|-45.5|
71041287|NCT01074008|141591221|SUPERIORITY_OR_OTHER||||||<|0.001||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-450/r group and 11 participants in the placebo group would provide \> 95% power to detect a 1.0 log10 difference with a common standard deviation of 0.5 log10 IU/mL using a two-sided, two-sample t-test with a significance level of 0.05.||||<0.001
70998123|NCT05109702|141503793|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.169||0.034|TWO_SIDED|95.0|-0.69|-0.028|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||-0.028|-0.690|0.034
70998124|NCT05109702|141503793|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.171||0.64|TWO_SIDED|95.0|-0.255|0.414|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.414|-0.255|0.640
71041288|NCT01074008|141591221|SUPERIORITY_OR_OTHER||||||<|0.001||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-450/r group and 11 participants in the placebo group would provide \> 95% power to detect a 1.0 log10 difference with a common standard deviation of 0.5 log10 IU/mL using a two-sided, two-sample t-test with a significance level of 0.05.||||<0.001
70923855|NCT04690673|141339580|EQUIVALENCE|Based on previous reports on the pharmacokinetics of oral paracetamol, the standard deviation of the within-subject difference in the Cmax for paracetamol was estimated to be 35% of the mean Cmax. Using this standard deviation, 10 participants were estimated to be sufficient, with a power of at least 80% (at 5% significance level). We recruited 12 volunteers to account for potential protocol violations or dropouts.|Geometric mean ratio|1.03||||0.05|TWO_SIDED|90.0|0.94|1.13||Not adjusted for multiple comparisons as the analysis was exploratory|t-test, 2 sided||Adhering|Highest paracetamol concentrations (Cmax) measured from capillary with the electrochemical method compared with measurements with mass-spectrometry.||1.13|0.94|0.05
70923856|NCT02662062|141339679|OTHER|This is a single arm study looking at a binary value with the hypothesis suggesting it falls within a certain range.||||||||||||||||The null hypothesis is that the addition of pembrolizumab to chemoradiation is not unsafe (percentage of the population experiencing unacceptable toxicity is not \>50%)|A Clopper-Pearson method was used to determine the unacceptable toxicity rate and a 95% confidence interval for this binary outcome measure.|||
70923857|NCT02662062|141339680|OTHER|Single arm study with no comparator arm and assessment of a binary variable. Clopper-Pearson method used to calculate the 95% confidence interval relating to this proportion.|||||||||||||||||Single arm study with no comparator arm and assessment of a binary variable. Clopper-Pearson method used to calculate the 95% confidence interval relating to this proportion.|||
70923858|NCT02662062|141339681|OTHER|Single arm study with no comparator arm and assessment of a binary variable. Clopper-Pearson method used to calculate the 95% confidence interval relating to this proportion.|||||||||||||||||Single arm study with no comparator arm and assessment of a binary variable. Clopper-Pearson method used to calculate the 95% confidence interval relating to this proportion.|||
70923859|NCT02662062|141339682|OTHER|Non comparative trial with a single arm|Kaplan Meier Estimate|39.0|||||TWO_SIDED|95.0|17.0||missing upper limit of 95% confidence interval on the survival estimate from Kaplan-Meier estimator due to small number events||||||||17|
70923860|NCT02662062|141339683|OTHER|Kaplan Meier Estimate performed for a 12 month timepoint in a single arm non comparative study|Kaplan Meier Estimate|92.0|||||TWO_SIDED|95.0|72.0|98.0||||||||98|72|
70923861|NCT02662062|141339684|OTHER|Kaplan Meier Estimate of single arm non comparative study|Kaplan Meier Estimate|85.0|||||TWO_SIDED|95.0|64.0|94.0||||||||94|64|
70923862|NCT02662062|141339685|OTHER|Kaplan Meier estimate at a 12 month timepoint for a single arm non comparative study|Kaplan Meier Estimate|88.0|||||TWO_SIDED|95.0|68.0|98.0||||||||98|68|
70923863|NCT05406921|141339718|SUPERIORITY||Mean Difference (Net)|0.32|||<|0.05|TWO_SIDED||||||ANOVA|||This was a feasibility study and not powered to detect significant differences pre-/post-intervention.||||<0.05
70923864|NCT04299009|141339722|OTHER|multilevel linear models with Epworth sleepiness score scores as the dependent variable; treatment block (BLT vs sBLT) as a fixed effect; treatment sequence as a covariate; and participant intercept as a random effect.|regression coefficient|2.45|||<|0.05|TWO_SIDED|95.0|-0.3|5.19|||Mixed Models Analysis|||||5.19|-0.30|<0.05
70923865|NCT00676715|141339724|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren Test (stratified)|||Van Elteren test is stratified by region and presence of baseline gadolinium-enhancing lesions (absent or present).||||<0.0001
70923866|NCT00676715|141339724|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren Test (stratified)|||Van Elteren test is stratified by region and presence of baseline gadolinium-enhancing lesions (absent or present).||||<0.0001
70923867|NCT00676715|141339724|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7496|||||||Van Elteren Test (stratified)|||Van Elteren test is stratified by region and presence of baseline gadolinium-enhancing lesions (absent or present).||||0.7496
70923868|NCT00676715|141339725|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019|||||||Poisson model|||Poisson model was fitted for adjusting for geographic region only.||||0.0019
70923869|NCT00676715|141339725|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0136|||||||Poisson model|||Poisson model was fitted for adjusting for geographic region only.||||0.0136
70923870|NCT00676715|141339725|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1814|||||||Poisson model|||Poisson model was fitted for adjusting for geographic region only.||||0.1814
70923871|NCT00676715|141339726|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (RR)|0.6||||0.1978|TWO_SIDED|95.0|0.27|1.34|||Cochran-Mantel-Haenszel chi-square test|Cochran-Mantel-Haenszel (CMH) chi-square test stratified by geographical region only.||||1.34|0.27|0.1978
70923872|NCT00676715|141339726|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (RR)|0.53||||0.131|TWO_SIDED|95.0|0.23|1.22|||CMH chi-square test|CMH chi-square test stratified by geographical region only.||||1.22|0.23|0.1310
70923873|NCT00676715|141339726|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (RR)|0.92||||0.8206|TWO_SIDED|95.0|0.46|1.84|||CMH chi-square tes|CMH chi-square test stratified by geographical region only.||||1.84|0.46|0.8206
70923874|NCT00676715|141339727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1391|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||0.1391
71100263|NCT01887600|141709221|SUPERIORITY||Least squares mean difference|1.692|||<|0.001||95.0|1.52|1.86|||ANCOVA|||The Analysis of Covariance (ANCOVA) with Multiple Imputations (MI) model, adjusting for covariates was used for the analysis. The model included treatment as fixed factor, region and history of CV disease as class factors and baseline Hb, baseline eGFR as continuous covariates. Superiority of roxadustat versus placebo was considered successful if the lower bound of the two-sided 95% confidence interval of the difference between treatment arms (roxadustat minus placebo) was higher than 0.||1.86|1.52|<0.001
71100264|NCT01887600|141709222|SUPERIORITY||Least squares mean difference|1.599|||<|0.001|TWO_SIDED|95.0|1.41|1.78||LSM Difference p-value is for test of differences. Tested using a fixed sequence testing procedure to maintain the overall two-sided type I error rate at 0.05.|Mixed Models Analysis|||The model includes treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit interaction as continuous covariates.||1.78|1.41|<0.001
70998125|NCT05109702|141503794|SUPERIORITY|Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.|LS Mean Difference|1.45|STANDARD_DEVIATION|2.893||0.615|TWO_SIDED|95.0|-4.223|7.133|||MMRM|||||7.133|-4.223|0.615
71100265|NCT01887600|141709223|SUPERIORITY|Superiority of roxadustat versus placebo was considered successful if the upper bound of the two-sided 95% confidence interval of the difference between treatment arms (roxadustat minus placebo) is below 0.|Least squares mean difference|-0.701|||<|0.001||95.0|-0.83|-0.57||LSM Difference p-value is for test of differences. Tested using a fixed sequence testing procedure to maintain the overall two-sided type I error rate at 0.05.|Mixed Models Analysis|||A Mixed Model of Repeated Measures has been applied up to week 28. The results were based on the estimated difference between the two treatment arms and overall mean effects during the period (weeks 12 to 28). The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb, baseline eGFR and baseline LDL as continuous variables.||-0.57|-0.83|<0.001
71100266|NCT01887600|141709224|SUPERIORITY||Hazard Ratio (HR)|0.238|||<|0.001|TWO_SIDED|95.0|0.17|0.33||Tested using a fixed sequence testing procedure to maintain the overall two-sided type I error rate at 0.05.|Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority is declared if the upper bound of the 95% CI is below 1.0.||0.33|0.17|<0.001
70923875|NCT00676715|141339727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1596|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||0.1596
70998126|NCT05109702|141503794|SUPERIORITY||LS Mean Difference|4.81|STANDARD_DEVIATION|2.894||0.097|TWO_SIDED|95.0|-0.866|10.494|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||10.494|-0.866|0.097
70998127|NCT05109702|141503794|SUPERIORITY||LS Mean Difference|1.06|STANDARD_DEVIATION|2.93||0.718|TWO_SIDED|95.0|-4.69|6.81|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||6.810|-4.690|0.718
70998128|NCT05109702|141503794|SUPERIORITY||LS Mean Difference|3.09|STANDARD_ERROR_OF_MEAN|2.963||0.298|TWO_SIDED|95.0|-2.728|8.903|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||8.903|-2.728|0.298
70998129|NCT05109702|141503795|SUPERIORITY||LS Mean Difference|2.67|STANDARD_ERROR_OF_MEAN|2.814||0.343|TWO_SIDED|95.0|-2.854|8.191|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||8.191|-2.854|0.343
71100267|NCT01887600|141709225|SUPERIORITY||Least squares mean difference|1.127|||=|0.093|TWO_SIDED|95.0|-0.19|2.44||LSM Difference p-value is for test of differences.Tested using a fixed sequence testing procedure to maintain the overall two-sided type I error rate at 0.05.|Mixed Models Analysis|||A Mixed Model of Repeated Measures has been applied using the visits up to week 28. The results were based on the estimated difference between the two treatment arms and overall mean effects throughout the evaluation period (weeks 12 to 28). The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline SF-36 VT, baseline Hb and baseline eGFR as continuous variables.||2.44|-0.19|=0.093
70998130|NCT05109702|141503795|SUPERIORITY||LS Mean Difference|3.71|STANDARD_ERROR_OF_MEAN|2.814||0.188|TWO_SIDED|95.0|-1.813|9.232|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||9.232|-1.813|0.188
70998131|NCT05109702|141503795|SUPERIORITY||LS Mean Difference|2.55|STANDARD_ERROR_OF_MEAN|2.849||0.371|TWO_SIDED|95.0|-3.04|8.143|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||8.143|-3.040|0.371
70998132|NCT05109702|141503795|SUPERIORITY||LS Mean Difference|6.92|STANDARD_ERROR_OF_MEAN|2.883||0.017|TWO_SIDED|95.0|1.259|12.573|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||12.573|1.259|0.017
70998133|NCT05109702|141503796|SUPERIORITY||LS Mean Difference|0.85|STANDARD_ERROR_OF_MEAN|2.7||0.754|TWO_SIDED|95.0|-4.452|6.147|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||6.147|-4.452|0.754
71041289|NCT01074008|141591221|SUPERIORITY_OR_OTHER||||||<|0.001||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-450/r group and 11 participants in the placebo group would provide \> 95% power to detect a 1.0 log10 difference with a common standard deviation of 0.5 log10 IU/mL using a two-sided, two-sample t-test with a significance level of 0.05.||||<0.001
71041290|NCT01074008|141591221|SUPERIORITY_OR_OTHER|||||||0.009||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-072 and 11 participants in the placebo group would provide 92% power to detect a 1.0 log10 difference with a standard deviation of 0.6 log10 IU/mL and a two-sided, two-sample t-test with a significance level of 0.05.||||0.009
71041291|NCT01074008|141591221|SUPERIORITY_OR_OTHER|||||||0.012||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-072 and 11 participants in the placebo group would provide 92% power to detect a 1.0 log10 difference with a standard deviation of 0.6 log10 IU/mL and a two-sided, two-sample t-test with a significance level of 0.05.||||0.012
71041292|NCT01074008|141591221|SUPERIORITY_OR_OTHER||||||<|0.001||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-072 and 11 participants in the placebo group would provide 92% power to detect a 1.0 log10 difference with a standard deviation of 0.6 log10 IU/mL and a two-sided, two-sample t-test with a significance level of 0.05.||||<0.001
71041293|NCT01074008|141591221|SUPERIORITY_OR_OTHER|||||||0.032||||||There was no adjustment for multiple comparisons and the pre-specified, 2-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight subjects per ABT-333 group and 11 subjects in the placebo group would provide 82% power to detect a 1.0 log10 IU/mL difference with a standard deviation of 0.7 log10 IU/mL and a 2-sided 2-sample t-test with a significance level of 0.05.||||0.032
71041294|NCT01074008|141591221|SUPERIORITY_OR_OTHER|||||||0.053||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-333 group and 11 participants in the placebo group would provide 82% power to detect a 1.0 log10 IU/mL difference with a standard deviation of 0.7 log10 IU/mL and a two-sided, two-sample t-test with a significance level of 0.05.||||0.053
71041295|NCT01074008|141591222|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.001
71041296|NCT01074008|141591222|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.006
71041297|NCT01074008|141591222|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||<0.001
71041298|NCT01074008|141591222|SUPERIORITY_OR_OTHER|||||||0.262|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.262
71041299|NCT01074008|141591222|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||1.000
70998134|NCT05109702|141503796|SUPERIORITY||LS Mean Difference|2.43|STANDARD_ERROR_OF_MEAN|2.7||0.368|TWO_SIDED|95.0|-2.865|7.731|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||7.731|-2.865|0.368
70998135|NCT05109702|141503796|SUPERIORITY||LS Mean Difference|1.35|STANDARD_ERROR_OF_MEAN|2.734||0.621|TWO_SIDED|95.0|-4.014|6.715|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||6.715|-4.014|0.621
70998136|NCT05109702|141503796|SUPERIORITY||LS Mean Difference|4.74|STANDARD_ERROR_OF_MEAN|2.766||0.087|TWO_SIDED|95.0|-0.688|10.168|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||10.168|-0.688|0.087
70998137|NCT05109702|141503797|SUPERIORITY||LS Mean Difference|4.23|STANDARD_ERROR_OF_MEAN|2.646||0.11|TWO_SIDED|95.0|-0.958|9.425|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||9.425|-0.958|0.110
70998138|NCT05109702|141503797|SUPERIORITY||LS Mean Difference|2.66|STANDARD_ERROR_OF_MEAN|2.647||0.315|TWO_SIDED|95.0|-2.535|7.855|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||7.855|-2.535|0.315
70998139|NCT05109702|141503797|SUPERIORITY||LS Mean Difference|2.67|STANDARD_DEVIATION|2.678||0.318|TWO_SIDED|95.0|-2.582|7.928|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||7.928|-2.582|0.318
70998140|NCT05109702|141503797|SUPERIORITY||LS Mean Difference|2.79|STANDARD_ERROR_OF_MEAN|2.71||0.303|TWO_SIDED|95.0|-2.525|8.111|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||8.111|-2.525|0.303
70998141|NCT05109702|141503798|SUPERIORITY||LS Mean Difference|4.44|STANDARD_ERROR_OF_MEAN|2.975||0.136|TWO_SIDED|95.0|-1.402|10.273|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||10.273|-1.402|0.136
70998142|NCT05109702|141503798|SUPERIORITY||LS Mean Difference|4.13|STANDARD_ERROR_OF_MEAN|2.972||0.165|TWO_SIDED|95.0|-1.7|9.966|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||9.966|-1.700|0.165
70998143|NCT05109702|141503798|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|3.008||0.665|TWO_SIDED|95.0|-4.6|7.207|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||7.207|-4.600|0.665
70998144|NCT05109702|141503798|SUPERIORITY||LS Mean Difference|5.02|STANDARD_ERROR_OF_MEAN|3.043||0.099|TWO_SIDED|95.0|-0.95|10.995|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||10.995|-0.950|0.099
71041300|NCT01074008|141591222|SUPERIORITY_OR_OTHER|||||||0.245|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.245
71041301|NCT01074008|141591222|SUPERIORITY_OR_OTHER|||||||0.111|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.111
71041302|NCT01074008|141591222|SUPERIORITY_OR_OTHER|||||||0.111|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.111
71041303|NCT01074008|141591223|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
71041304|NCT01074008|141591223|SUPERIORITY_OR_OTHER|||||||0.059|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.059
71041305|NCT01074008|141591223|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
70998145|NCT05109702|141503799|SUPERIORITY||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|2.926||0.861|TWO_SIDED|95.0|-5.232|6.254|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||6.254|-5.232|0.861
70998146|NCT05109702|141503799|SUPERIORITY||LS Mean Difference|1.76|STANDARD_ERROR_OF_MEAN|2.925||0.548|TWO_SIDED|95.0|-3.983|7.497|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||7.497|-3.983|0.548
71008556|NCT02055976|141525226|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-67.254|STANDARD_ERROR_OF_MEAN|4.785|<|0.001|TWO_SIDED|95.0|-76.757|-57.752|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-57.752|-76.757|<0.001
70923876|NCT00676715|141339727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.474|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||0.4740
70923877|NCT00676715|141339728|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||<0.0001
71008557|NCT02055976|141525226|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-87.122|STANDARD_ERROR_OF_MEAN|4.959|<|0.001|TWO_SIDED|95.0|-96.969|-77.275|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-77.275|-96.969|<0.001
71008558|NCT02055976|141525226|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-93.327|STANDARD_ERROR_OF_MEAN|4.949|<|0.001|TWO_SIDED|95.0|-103.153|-83.501|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-83.501|-103.153|<0.001
71008559|NCT02055976|141525226|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-71.724|STANDARD_ERROR_OF_MEAN|6.243|<|0.001|TWO_SIDED|95.0|-84.128|-59.321|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-59.321|-84.128|<0.001
71008560|NCT02055976|141525226|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-96.206|STANDARD_ERROR_OF_MEAN|6.209|<|0.001|TWO_SIDED|95.0|-108.541|-83.872|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-83.872|-108.541|<0.001
71008561|NCT02055976|141525226|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-98.533|STANDARD_ERROR_OF_MEAN|6.145|<|0.001|TWO_SIDED|95.0|-110.743|-86.323|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-86.323|-110.743|<0.001
71008562|NCT02055976|141525226|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.225|STANDARD_ERROR_OF_MEAN|4.736|<|0.001|TWO_SIDED|95.0|-65.63|-46.819|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-46.819|-65.630|<0.001
71008563|NCT02055976|141525226|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-73.813|STANDARD_ERROR_OF_MEAN|4.881|<|0.001|TWO_SIDED|95.0|-83.507|-64.119|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-64.119|-83.507|<0.001
71008564|NCT02055976|141525226|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-81.239|STANDARD_ERROR_OF_MEAN|4.885|<|0.001|TWO_SIDED|95.0|-90.939|-71.538|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-71.538|-90.939|<0.001
71008565|NCT02055976|141525226|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-72.573|STANDARD_ERROR_OF_MEAN|5.983|<|0.001|TWO_SIDED|95.0|-84.461|-60.684|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-60.684|-84.461|<0.001
71008566|NCT02055976|141525226|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-96.222|STANDARD_ERROR_OF_MEAN|5.948|<|0.001|TWO_SIDED|95.0|-108.039|-84.405|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-84.405|-108.039|<0.001
70998147|NCT05109702|141503799|SUPERIORITY||LS Mean Difference|3.97|STANDARD_ERROR_OF_MEAN|2.96||0.18|TWO_SIDED|95.0|-1.839|9.777|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||9.777|-1.839|0.180
70998148|NCT05109702|141503799|SUPERIORITY||LS Mean Difference|3.93|STANDARD_ERROR_OF_MEAN|2.993||0.189|TWO_SIDED|95.0|-1.941|9.807|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||9.807|-1.941|0.189
70998149|NCT05109702|141503800|SUPERIORITY||LS Mean Difference|1.32|STANDARD_ERROR_OF_MEAN|2.608||0.613|TWO_SIDED|95.0|-3.799|6.438|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||6.438|-3.799|0.613
70998150|NCT05109702|141503800|SUPERIORITY||LS Mean Difference|4.53|STANDARD_ERROR_OF_MEAN|2.609||0.083|TWO_SIDED|95.0|-0.586|9.653|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||9.653|-0.586|0.083
70998151|NCT05109702|141503800|SUPERIORITY||LS Mean Difference|3.67|STANDARD_ERROR_OF_MEAN|2.639||0.165|TWO_SIDED|95.0|-1.508|8.851|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||8.851|-1.508|0.165
70998152|NCT05109702|141503800|SUPERIORITY||LS Mean Difference|4.28|STANDARD_ERROR_OF_MEAN|2.672||0.11|TWO_SIDED|95.0|-0.964|9.522|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||9.522|-0.964|0.110
70998153|NCT05109702|141503801|SUPERIORITY||LS Mean Difference|3.57|STANDARD_ERROR_OF_MEAN|1.743||0.041|TWO_SIDED|95.0|0.154|6.994|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||6.994|0.154|0.041
70998154|NCT05109702|141503801|SUPERIORITY||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|1.743||0.122|TWO_SIDED|95.0|-0.723|6.118|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||6.118|-0.723|0.122
70998155|NCT05109702|141503801|SUPERIORITY||LS Mean Difference|4.6|STANDARD_ERROR_OF_MEAN|1.76||0.009|TWO_SIDED|95.0|1.146|8.056|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||8.056|1.146|0.009
71041306|NCT01074008|141591223|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
71041307|NCT01074008|141591223|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.370
70998156|NCT05109702|141503801|SUPERIORITY||LS Mean Difference|4.04|STANDARD_ERROR_OF_MEAN|1.781||0.024|TWO_SIDED|95.0|0.544|7.536|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||7.536|0.544|0.024
71041308|NCT01074008|141591223|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
71041309|NCT01074008|141591223|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
71041310|NCT01074008|141591223|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
71041311|NCT01074008|141591236|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.005
71041312|NCT01074008|141591236|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.005
70998157|NCT05109702|141503802|SUPERIORITY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.13||0.282|TWO_SIDED|95.0|-0.115|0.394|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.394|-0.115|0.282
70998158|NCT05109702|141503802|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.13||0.353|TWO_SIDED|95.0|-0.134|0.375|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.375|-0.134|0.353
70998159|NCT05109702|141503802|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.131||0.764|TWO_SIDED|95.0|-0.297|0.218|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.218|-0.297|0.764
71041313|NCT01074008|141591236|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||<0.001
71041314|NCT01074008|141591236|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.024
71041315|NCT01074008|141591236|SUPERIORITY_OR_OTHER|||||||0.319|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.319
71041316|NCT01074008|141591236|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
71041317|NCT01074008|141591236|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.005
71041318|NCT01074008|141591236|SUPERIORITY_OR_OTHER|||||||0.074|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.074
71041319|NCT00603564|141591256|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||endpoint was analyzed in terms of time by comparison of mean +- SD||||<0.001
71041320|NCT00603564|141591257|SUPERIORITY_OR_OTHER|||||||7e-06||95.0|||||Chi-squared|||||||0.000007
71041321|NCT01350934|141591261|SUPERIORITY_OR_OTHER_LEGACY||Estimated Difference|1.95|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|0.8|3.1|||Longitudinal data analysis|||||3.1|0.8|<0.001
71041322|NCT01350934|141591262|SUPERIORITY_OR_OTHER_LEGACY||Estimated Difference|2.92|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|1.8|4.1|||Longitudinal data analysis|||||4.1|1.8|<0.001
71041323|NCT01350934|141591263|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-42.37|||<|0.001|TWO_SIDED|95.0|-48.16|-36.67|||Constrained longitudinal data analysis|||||-36.67|-48.16|<0.001
71041324|NCT01350934|141591264|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-52.03|||<|0.001|TWO_SIDED|95.0|-59.04|-45.3|||Constrained longitudinal data analysis|||||-45.30|-59.04|<0.001
71041325|NCT01350934|141591265|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-51.07|||<|0.001|TWO_SIDED|95.0|-57.29|-44.99|||Constrained longitudinal data analysis|||||-44.99|-57.29|<0.001
71041326|NCT01350934|141591266|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-51.96|||<|0.001|TWO_SIDED|95.0|-58.77|-45.39|||Constrained longitudinal data analysis|||||-45.39|-58.77|<0.001
71041327|NCT01350934|141591267|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0279|||<|0.001|TWO_SIDED|95.0|0.0074|0.1048|||Cochran-Mantel-Haenszel|||Odds Ratio comparison of percentage of participants with \<20 ng/mL of serum 25-hydroxyvitamin (OH) D between Fosamax Plus group and Calcitriol group.||0.1048|0.0074|<0.001
71041328|NCT01196117|141591269|SUPERIORITY|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||||||0.0009
71041329|NCT01196117|141591270|SUPERIORITY|||||||0.8938|||||||Wilcoxon (Mann-Whitney)|||||||0.8938
71041330|NCT01196117|141591271|SUPERIORITY||||||<|0.014|||||||Wilcoxon (Mann-Whitney)|||||||<0.014
71041331|NCT01196117|141591272|SUPERIORITY||||||<|0.02|||||||Wilcoxon (Mann-Whitney)|||||||<0.0200
71041332|NCT01196117|141591273|SUPERIORITY|||||||0.1321|||||||Wilcoxon (Mann-Whitney)|||||||0.1321
71041333|NCT01196117|141591274|SUPERIORITY||||||<|0.249|||||||Wilcoxon (Mann-Whitney)|||||||<0.2490
71041334|NCT01196117|141591275|SUPERIORITY|||||||0.5139|||||||Wilcoxon (Mann-Whitney)|||||||0.5139
71041335|NCT01196117|141591276|SUPERIORITY|||||||0.0597|||||||Wilcoxon (Mann-Whitney)|||||||0.0597
71041336|NCT01196117|141591277|SUPERIORITY|||||||0.2134|||||||Wilcoxon (Mann-Whitney)|||||||0.2134
71041337|NCT03239496|141591279|NON_INFERIORITY|All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.||||||0.05|||||||t-test, 1 sided|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.05
71041338|NCT03239496|141591280|NON_INFERIORITY|All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.||||||0.05|||||||t-test, 2 sided|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.05
70998160|NCT05109702|141503802|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.133||0.104|TWO_SIDED|95.0|-0.044|0.476|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.476|-0.044|0.104
70998161|NCT05109702|141503803|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.15||0.969|TWO_SIDED|95.0|-0.3|0.288|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.288|-0.300|0.969
70998162|NCT05109702|141503803|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.15||0.504|TWO_SIDED|95.0|-0.194|0.394|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.394|-0.194|0.504
70998163|NCT05109702|141503803|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.152||0.915|TWO_SIDED|95.0|-0.281|0.314|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.314|-0.281|0.915
70998164|NCT05109702|141503803|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.153||0.195|TWO_SIDED|95.0|-0.102|0.499|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.499|-0.102|0.195
70998165|NCT05109702|141503804|SUPERIORITY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.148||0.287|TWO_SIDED|95.0|-0.133|0.449|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.449|-0.133|0.287
70998166|NCT05109702|141503804|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.148||0.26|TWO_SIDED|95.0|-0.124|0.458|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.458|-0.124|0.260
70998167|NCT05109702|141503804|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.15||0.987|TWO_SIDED|95.0|-0.296|0.291|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.291|-0.296|0.987
70998168|NCT05109702|141503804|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.151||0.143|TWO_SIDED|95.0|-0.075|0.519|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.519|-0.075|0.143
70998169|NCT05109702|141503805|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.151||-0.198|TWO_SIDED|95.0|-0.102|0.49|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.490|-0.102|-0.198
71008567|NCT02055976|141525226|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-102.184|STANDARD_ERROR_OF_MEAN|5.919|<|0.001|TWO_SIDED|95.0|-113.945|-90.424|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-90.424|-113.945|<0.001
70923878|NCT00676715|141339728|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||<0.0001
71008568|NCT02055976|141525228|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-69.537|STANDARD_ERROR_OF_MEAN|5.721|<|0.001|TWO_SIDED|95.0|-80.9|-58.175|||Mixed Models Analysis|One-sided p-value (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-58.175|-80.900|<0.001
70923879|NCT00676715|141339728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4985|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||0.4985
71100268|NCT01887600|141709226|SUPERIORITY||Least squares mean difference|0.713|||=|0.27|TWO_SIDED|95.0|-0.56|1.98||LSM Difference p-value is for test of differences. Tested using a fixed sequence testing procedure to maintain the overall two-sided type I error rate at 0.05.|Mixed Models Analysis|||A Mixed Model of Repeated Measures has been applied using the visits up to week 28. The results were based on the estimated difference between the two treatment arms and overall mean effects throughout the evaluation period (weeks 12 to 28). The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline SF-36 PF, baseline Hb and baseline eGFR as continuous variables.||1.98|-0.56|=0.27
71100269|NCT01887600|141709227|NON_INFERIORITY|Non-inferiority can be concluded if the upper bound of the two-sided 95% CI of the difference between roxadustat and placebo (roxadustat minus placebo) is below 2 mmHg.|Least squares mean difference|0.842|||=|0.182|TWO_SIDED|95.0|-0.4|2.08||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Mixed Model of Repeated Measures was applied using the visits up to week 28. The results were based on the estimated difference between the two treatment arms with overall mean effects throughout the evaluation period (weeks 20 to 28). The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline MAP, baseline Hb, baseline eGFR as continuous covariates.||2.08|-0.40|=0.182
71100270|NCT01887600|141709228|NON_INFERIORITY|Non-inferiority is declared if the upper bound of the 95% CI is below 1.3 (hazard ratio).|Hazard Ratio (HR)|1.29|||=|0.334|TWO_SIDED|95.0|0.77|2.16|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||2.16|0.77|=0.334
71100271|NCT01887600|141709229|SUPERIORITY||Least squares mean difference|0.59|||=|0.316|TWO_SIDED|95.0|-0.57|1.75|||Mixed Models Analysis|||Annualized eGFR slope over time was estimated by a random slopes and intercepts model using all available eGFR values adjusted on baseline Hb, region, CV history at Baseline and the interaction terms.||1.75|-0.57|=0.316
71100272|NCT01887600|141709230|SUPERIORITY||Least squares mean difference|1.638|||<|0.001|TWO_SIDED|95.0|1.44|1.84||LSM Difference p-value is for test of differences|Mixed Models Analysis|||Average Level of Hb Over Weeks 28 to 36. A Mixed Model of Repeated Measures was applied using the visits over weeks 28 to 36. The results were based on the estimated difference between the two treatment arms by visit based on this MMRM model. The model included treatment arm, region, CV History, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.84|1.44|<0.001
71100273|NCT01887600|141709231|SUPERIORITY||Least squares mean difference|1.604|||<|0.001|TWO_SIDED|95.0|1.39|1.82||LSM difference p-value is for test of differences.|Mixed Models Analysis|||Average Level of Hb Over Weeks 44 to 52. A Mixed Model of Repeated Measures was applied using the visits over weeks 44 to 52. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.82|1.39|<0.001
71100274|NCT01887600|141709232|SUPERIORITY||Least squares mean difference|1.492|||<|0.001|TWO_SIDED|95.0|1.14|1.85||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Average Level of Hb Over Weeks 96 to 104. A Mixed Model of Repeated Measures was applied using the visits over weeks 96 to 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.85|1.14|<0.001
71100275|NCT01887600|141709233|SUPERIORITY||Hazard Ratio (HR)|19.001|||<|0.001|TWO_SIDED|95.0|11.98|30.15|||Regression, Cox|||Time to Achieve the First Hb Response. Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||30.15|11.98|<0.001
70923880|NCT00676715|141339729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||0.0004
71100276|NCT01887600|141709234|SUPERIORITY||Least squares mean difference|0.396|||<|0.001|TWO_SIDED|95.0|0.29|0.5||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 1. A Mixed Model of Repeated Measures was applied using the visits up to week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||0.50|0.29|<0.001
71100277|NCT01887600|141709234|SUPERIORITY||Least squares mean difference|0.938|||<|0.001|TWO_SIDED|95.0|0.81|1.07||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 2. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.07|0.81|<0.001
71100278|NCT01887600|141709234|SUPERIORITY||Least squares mean difference|1.471|||<|0.001|TWO_SIDED|95.0|1.3|1.64||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 4. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.64|1.30|<0.001
71100279|NCT01887600|141709234|SUPERIORITY||Least squares mean difference|1.827|||<|0.001|TWO_SIDED|95.0|1.64|2.02||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 6. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.02|1.64|<0.001
70998170|NCT05109702|141503805|SUPERIORITY||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.151||0.076|TWO_SIDED|95.0|-0.028|0.564|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.564|-0.028|0.076
70998171|NCT05109702|141503805|SUPERIORITY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.152||0.656|TWO_SIDED|95.0|-0.231|0.367|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.367|-0.231|0.656
70998172|NCT05109702|141503805|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.154||0.324|TWO_SIDED|95.0|-0.15|0.454|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.454|-0.150|0.324
70998173|NCT05109702|141503806|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.146||0.477|TWO_SIDED|95.0|-0.182|0.39|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.390|-0.182|0.477
70998174|NCT05109702|141503806|SUPERIORITY||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.146||0.033|TWO_SIDED|95.0|0.026|0.598|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.598|0.026|0.033
70998175|NCT05109702|141503806|SUPERIORITY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.147||0.374|TWO_SIDED|95.0|-0.158|0.42|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.420|-0.158|0.374
70998176|NCT05109702|141503806|SUPERIORITY||LS Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.149||0.114|TWO_SIDED|95.0|-0.056|0.529|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.529|-0.056|0.114
70998177|NCT05109702|141503807|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.329||0.598|TWO_SIDED|95.0|-0.822|0.475|||t-test, 2 sided|||Immediately Upon Instillation at Week 1||0.475|-0.822|0.598
70998178|NCT05109702|141503807|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.268||0.343|TWO_SIDED|95.0|-0.783|0.273|||t-test, 2 sided|||1 Minute Post Instillation at Week 1||0.273|-0.783|0.343
70998179|NCT05109702|141503807|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.25||0.359|TWO_SIDED|95.0|-0.721|0.262|||t-test, 2 sided|||2 Minutes Post Instillation at Week 1||0.262|-0.721|0.359
70998180|NCT03812588|141503808|SUPERIORITY||Slope|7.9|STANDARD_ERROR_OF_MEAN|7.261||0.292|TWO_SIDED|||||Linear regression model of condition in predicting change in HRSD-24. P-value and coefficient are Medication:Track. Medication (Escitalopram or Placebo) with Track (RFM or CFM) as co-variates. The threshold for statistical significance was p\>0.05.|Regression, Linear|||||||0.292
71041339|NCT03239496|141591281|NON_INFERIORITY|All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.||||||0.05|||||||t-test, 2 sided|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.05
70998181|NCT00180271|141503811|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66|||<|0.001|TWO_SIDED|95.0|0.52|0.84||The trial involved prespecified event monitoring at up to 20 successive periods by an independent DSMB to permit trial termination if the CRT-D was superior to, inferior to, or not different from ICD according to prespecified stopping rules.|Log Rank||A Hazard ratio \< 1.0 would indicate that the result favors CRT-D.|The trial utilized a Wang-Tsiatis (delta=0.1) group-sequential design with 95% power to detect a hazard ratio of 0.75 at a two-sided significance level of 0.05. Primary analysis based on statistical evaluation comparing the life-table event-free survival time graphs for CRT-D and ICD-only arms of the trial. Stratified Cox proportional-hazards regression was used to estimate a hazard ratio and statistical significance was evaluated with the log-rank test. Stratified by center and ischemic status.||0.84|0.52|< 0.001
70923881|NCT00676715|141339729|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||<0.0001
70998182|NCT00180271|141503812|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.001|TWO_SIDED|95.0|0.53|0.86|||Andersen-Gill|Andersen-Gill model performed, adjusted for a previous HF event in the study, stratified by ischemic status and using robust variance estimation.|Model adjusted for previously experienced heart failure event in the study. Hazard Ratio (95% CI) comparing patients with a previous heart failure event to those patients without a prior heart failure event equaled 8.84 (6084, 11.43), p\<0.001.|||0.86|0.53|0.001
70998183|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|0.81||||0.0856|TWO_SIDED|95.0|0.69|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.96|0.69|0.0856
70998184|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|0.99||||0.8546|TWO_SIDED|95.0|0.84|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.16|0.84|0.8546
70998185|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|0.73||||0.0012|TWO_SIDED|95.0|0.62|0.86||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.86|0.62|0.0012
70998186|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|1.02||||0.8414|TWO_SIDED|95.0|0.87|1.2||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.20|0.87|0.8414
71041340|NCT03239496|141591282|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.0001
71041341|NCT03239496|141591283|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.0001
71041342|NCT03239496|141591284|NON_INFERIORITY|All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.||||||0.05|||||||t-test, 2 sided|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.05
71100280|NCT01887600|141709234|SUPERIORITY||Least squares mean difference|2.058|||<|0.001|TWO_SIDED|95.0|1.87|2.25||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 8. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.25|1.87|<0.001
71100281|NCT01887600|141709234|SUPERIORITY||Least squares mean difference|1.949|||<|0.001|TWO_SIDED|95.0|1.75|2.14||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 10. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.14|1.75|<0.001
70998187|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|0.83||||0.2412|TWO_SIDED|95.0|0.64|1.08||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.08|0.64|0.2412
70998188|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|1.13||||0.4548|TWO_SIDED|95.0|0.88|1.44||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.44|0.88|0.4548
70998189|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|0.69||||0.0093|TWO_SIDED|95.0|0.53|0.88||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.88|0.53|0.0093
70998190|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|1.1||||0.8414|TWO_SIDED|95.0|0.86|1.42||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.42|0.86|0.8414
70998191|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|0.87||||0.1749|TWO_SIDED|95.0|0.75|1.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.00|0.75|0.1749
70998192|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|1.11||||0.3121|TWO_SIDED|95.0|0.96|1.27||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.27|0.96|0.3121
70998193|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|0.89||||0.1351|TWO_SIDED|95.0|0.78|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.03|0.78|0.1351
70998194|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|1.07||||0.8414|TWO_SIDED|95.0|0.93|1.24||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.24|0.93|0.8414
70998195|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|0.83||||0.2158|TWO_SIDED|95.0|0.67|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.03|0.67|0.2158
70998196|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|0.88||||0.3279|TWO_SIDED|95.0|0.71|1.08||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.08|0.71|0.3279
70998197|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|0.88||||0.2472|TWO_SIDED|95.0|0.72|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.09|0.72|0.2472
70998198|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|0.98||||0.8414|TWO_SIDED|95.0|0.79|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.21|0.79|0.8414
70998199|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.6193|TWO_SIDED|95.0|0.81|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.81|0.6193
70998200|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|1.13||||0.3121|TWO_SIDED|95.0|0.96|1.32||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.32|0.96|0.3121
70998201|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|0.82||||0.0191|TWO_SIDED|95.0|0.7|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.96|0.70|0.0191
70998202|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|1.14||||0.8414|TWO_SIDED|95.0|0.97|1.33||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.33|0.97|0.8414
70998203|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.2412|TWO_SIDED|95.0|0.76|1.05||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.05|0.76|0.2412
70998204|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|1.15||||0.3121|TWO_SIDED|95.0|0.99|1.35||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.35|0.99|0.3121
70998205|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|0.8||||0.0135|TWO_SIDED|95.0|0.68|0.94||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.94|0.68|0.0135
70998206|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.8414|TWO_SIDED|95.0|0.87|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.21|0.87|0.8414
70998207|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|0.81||||0.1749|TWO_SIDED|95.0|0.66|1.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.00|0.66|0.1749
70998208|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|1.15||||0.3121|TWO_SIDED|95.0|0.93|1.41||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.41|0.93|0.3121
70998209|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|0.7||||0.0038|TWO_SIDED|95.0|0.57|0.86||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.86|0.57|0.0038
70998210|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.8414|TWO_SIDED|95.0|0.84|1.27||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.27|0.84|0.8414
70998211|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.2412|TWO_SIDED|95.0|0.76|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.76|0.2412
70998212|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|1.2||||0.2053|TWO_SIDED|95.0|1.02|1.41||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.41|1.02|0.2053
70998213|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|0.82||||0.0241|TWO_SIDED|95.0|0.7|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.96|0.70|0.0241
71041343|NCT03239496|141591285|NON_INFERIORITY|All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.||||||0.05|||||||t-test, 2 sided|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.05
70998214|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.8414|TWO_SIDED|95.0|0.88|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.88|0.8414
70998215|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|0.81||||0.0732|TWO_SIDED|95.0|0.69|0.94||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.94|0.69|0.0732
70998216|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.609|TWO_SIDED|95.0|0.82|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.82|0.6090
70998217|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|0.65|||<|0.0001|TWO_SIDED|95.0|0.56|0.76||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.76|0.56|<0.0001
70998218|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|0.96||||0.8414|TWO_SIDED|95.0|0.82|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.82|0.8414
70998219|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|0.98||||0.7828|TWO_SIDED|95.0|0.82|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.16|0.82|0.7828
70998220|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|1.21||||0.2053|TWO_SIDED|95.0|1.02|1.43||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.43|1.02|0.2053
70998221|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|0.77||||0.0093|TWO_SIDED|95.0|0.65|0.92||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.92|0.65|0.0093
70998222|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|1.11||||0.8414|TWO_SIDED|95.0|0.93|1.31||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.31|0.93|0.8414
70998223|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|0.88||||0.2412|TWO_SIDED|95.0|0.73|1.07||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.07|0.73|0.2412
70998224|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|1.14||||0.3121|TWO_SIDED|95.0|0.95|1.37||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.37|0.95|0.3121
70998225|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|0.77||||0.0135|TWO_SIDED|95.0|0.64|0.93||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.93|0.64|0.0135
70998226|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|1.11||||0.8414|TWO_SIDED|95.0|0.92|1.34||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.34|0.92|0.8414
70998227|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.2412|TWO_SIDED|95.0|0.79|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.03|0.79|0.2412
71041344|NCT03239496|141591286|NON_INFERIORITY|All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.||||||0.05|||||||t-test, 2 sided|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.05
70998228|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.6652|TWO_SIDED|95.0|0.91|1.18||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.18|0.91|0.6652
70998229|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.0275|TWO_SIDED|95.0|0.75|0.98||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.98|0.75|0.0275
70998230|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|1.06||||0.8414|TWO_SIDED|95.0|0.93|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.21|0.93|0.8414
70998231|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.2412|TWO_SIDED|95.0|0.76|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.76|0.2412
70998232|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|1.13||||0.3121|TWO_SIDED|95.0|0.96|1.32||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.32|0.96|0.3121
70998233|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|0.84||||0.0387|TWO_SIDED|95.0|0.72|0.99||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.99|0.72|0.0387
70923882|NCT00676715|141339729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2725|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||0.2725
71041345|NCT02339415|141591297|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.07||0.26|TWO_SIDED|95.0|-0.06|0.21|||Mixed Models Analysis|included predictors: treatment, assigned treatment sequence and pre-treatment biomarker level.|because biomarkers were analyzed on natural log scale, the estimated parameter is the log-transformed mean percent difference in treatment effect on Edoxaban vs. Placebo.|||0.21|-0.06|0.26
71041346|NCT02339415|141591298|SUPERIORITY||Mean Difference (Net)|-0.54|STANDARD_ERROR_OF_MEAN|0.17||0.002|TWO_SIDED|95.0|-0.88|-0.2|||Mixed Models Analysis|included predictors: treatment, assigned treatment sequence and pre-treatment biomarker level.|because biomarkers were analyzed on natural log scale, the estimated parameter is the log-transformed mean percent difference in treatment effect on Edoxaban vs. Placebo.|||-0.20|-0.88|0.002
71041347|NCT00003404|141591300|OTHER||rate of occurance|0.35|||||TWO_SIDED|95.0|0.0|8.0|||||The local recurrence rate was estimated by dividing the number of recurrences by the total sample size. An exact 95% confidence interval (95% CI) for this rate was determined by binomial distribution.|||8|0|
71041348|NCT00676650|141591302|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.914||||0.1678|TWO_SIDED|95.0|0.762|1.097||1-sided p-value from the stratified log-rank test|Log Rank||Based on the Cox Proportional hazards model stratified by Eastern Cooperative Oncology Group (ECOG) and Disease Progression Base.|||1.097|0.762|0.1678
71041349|NCT00676650|141591303|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.725|||<|0.001|TWO_SIDED|95.0|0.591|0.89||1-sided p-value from the stratified log-rank test.|Log Rank||Based on Cox Proportional Hazards Model stratified by ECOG and Disease Progression Base.|||0.890|0.591|<0.001
71041350|NCT00676650|141591304|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.561||||0.04|TWO_SIDED|95.0|1.0|19.0||p-value from 2-sided Fisher's Exact test.|Fisher Exact|||||19.0|1.0|0.040
70998234|NCT01392378|141503821|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.8414|TWO_SIDED|95.0|0.89|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.89|0.8414
71041351|NCT00683592|141591309|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean Change|-2.5||||0.009|TWO_SIDED|95.0|-4.4|-0.6|||ANCOVA|||The model was an analysis of covariance (ANCOVA), with terms for treatment group and center, adjusting for baseline MADRS total score. Missing values at week 8 were handled using the last observation carried forward (LOCF) approach.||-0.6|-4.4|0.009
71041352|NCT00683592|141591310|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean Change|-1.6||||0.026|TWO_SIDED|95.0|-3.1|-0.2|||ANCOVA|||The model was an analysis of covariance (ANCOVA), with terms for treatment group and center, adjusting for baseline HAM-D 17 total score. Missing values at week 8 were handled using the last observation carried forward (LOCF) approach.||-0.2|-3.1|0.026
71041353|NCT00683592|141591311|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean Improve|-0.3||||0.004|TWO_SIDED|95.0|-0.5|-0.1|||ANOVA|||The model was an analysis of variance (ANOVA), with terms for treatment group and center. Missing values at week 8 were handled using the last observation carried forward (LOCF) approach.||-0.1|-0.5|0.004
71041354|NCT00683592|141591312|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean Change|-1.2||||0.037|TWO_SIDED|95.0|-2.4|-0.1|||ANCOVA|||The model was an analysis of covariance (ANCOVA), with terms for treatment group and center, adjusting for baseline HAM-A total score. Missing values at week 8 were handled using the last observation carried forward (LOCF) approach.||-0.1|-2.4|0.037
71041355|NCT00683592|141591313|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.134||||0.002|TWO_SIDED|95.0|0.047|0.221|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel tests were used to compare MADRS response rates between the treatment groups, stratifying by center. The asymptotic confidence interval of the risk difference was estimated by the normal approximation to the binomial distribution.||0.221|0.047|0.002
71041356|NCT00683592|141591314|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.069||||0.066|TWO_SIDED|95.0|-0.008|0.147|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel tests were used to compare MADRS remission rates between the treatment groups, stratifying by center. The asymptotic confidence interval of the risk difference was estimated by the normal approximation to the binomial distribution.||0.147|-0.008|0.066
70998235|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|0.99||||0.935|TWO_SIDED|95.0|0.82|1.19||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.19|0.82|0.9350
71041357|NCT03653026|141591315|SUPERIORITY||Adjusted Response Rate Difference|29.0|||<|0.001|TWO_SIDED|95.0|23.2|34.7||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||34.7|23.2|<0.001
71041358|NCT03653026|141591316|SUPERIORITY||Adjusted Response Rate Difference|35.1|||<|0.001|TWO_SIDED|95.0|28.6|41.6||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||41.6|28.6|<0.001
71041359|NCT03653026|141591317|SUPERIORITY||Adjusted Response Rate Difference|15.9|||<|0.001|TWO_SIDED|95.0|11.4|20.3||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||20.3|11.4|<0.001
71041360|NCT03653026|141591318|SUPERIORITY||Adjusted Response Rate Difference|49.4|||<|0.001|TWO_SIDED|95.0|41.7|57.1||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||57.1|41.7|<0.001
71041361|NCT03653026|141591319|SUPERIORITY||Adjusted Response Rate Difference|37.0|||<|0.001|TWO_SIDED|95.0|28.8|45.1||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||45.1|28.8|<0.001
71041362|NCT03653026|141591320|SUPERIORITY||Adjusted Response Rate Difference|30.1|||<|0.001|TWO_SIDED|95.0|24.1|36.2||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - placebo|||36.2|24.1|<0.001
71041363|NCT03653026|141591321|SUPERIORITY||Adjusted Response Rate Difference|27.1|||<|0.001|TWO_SIDED|95.0|19.0|35.3||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (\<= 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||35.3|19.0|<0.001
71041364|NCT03653026|141591322|SUPERIORITY||Adjusted Response Rate Difference|29.1|||<|0.001|TWO_SIDED|95.0|20.9|37.4||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||37.4|20.9|<0.001
70998236|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|1.11||||0.7918|TWO_SIDED|95.0|0.93|1.32||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.32|0.93|0.7918
70998237|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|0.96||||0.6922|TWO_SIDED|95.0|0.8|1.14||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.14|0.80|0.6922
70998238|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|1.11||||0.9765|TWO_SIDED|95.0|0.93|1.32||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.32|0.93|0.9765
71041365|NCT03653026|141591323|SUPERIORITY||Adjusted Response Rate Difference|37.9|||<|0.001|TWO_SIDED|95.0|29.8|46.1||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||46.1|29.8|<0.001
71041366|NCT03653026|141591324|SUPERIORITY||Least Squares (LS) Mean Difference|31.2|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|24.98|37.36||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Mixed-effect model repeated measurement|MMRM with Baseline, treatment, visit, treatment-by-visit interaction, and strata (Baseline Adapted Mayo score, corticosteroid use, and bio-IR status).|Difference = Upadacitinib 45 mg - Placebo|||37.36|24.98|<0.001
71041367|NCT03653026|141591325|SUPERIORITY||Adjusted Response Rate Difference|11.3|||<|0.001|TWO_SIDED|95.0|7.2|15.3||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||15.3|7.2|<0.001
71041368|NCT03653026|141591326|SUPERIORITY||LS Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|4.19|7.73||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Mixed-effect model repeated measurement|MMRM with Baseline, treatment, visit, treatment-by-visit interaction, and strata (Baseline Adapted Mayo score, corticosteroid use, and bio-IR status).|Difference = Upadacitinib 45 mg - Placebo|||7.73|4.19|<0.001
70998239|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.6915|TWO_SIDED|95.0|0.78|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.78|0.6915
70998240|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|1.13||||0.7918|TWO_SIDED|95.0|0.94|1.36||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.36|0.94|0.7918
70998241|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.4389|TWO_SIDED|95.0|0.75|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.09|0.75|0.4389
70998242|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.9765|TWO_SIDED|95.0|0.85|1.24||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.24|0.85|0.9765
70998243|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|0.99||||0.935|TWO_SIDED|95.0|0.87|1.14||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.14|0.87|0.9350
70998244|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.7918|TWO_SIDED|95.0|0.9|1.18||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.18|0.90|0.7918
70998245|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|1.0||||0.943|TWO_SIDED|95.0|0.88|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.88|0.9430
70998246|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|0.98||||0.9765|TWO_SIDED|95.0|0.85|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.85|0.9765
70998247|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|0.89||||0.5167|TWO_SIDED|95.0|0.74|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.74|0.5167
70998248|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.7918|TWO_SIDED|95.0|0.78|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.78|0.7918
71100282|NCT01887600|141709234|SUPERIORITY||Least squares mean difference|2.09|||<|0.001|TWO_SIDED|95.0|1.9|2.28||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 12. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit.The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.28|1.90|<0.001
71100283|NCT01887600|141709234|SUPERIORITY||Least squares mean difference|2.051|||<|0.001|TWO_SIDED|95.0|1.86|2.24||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 14. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.24|1.86|<0.001
71100284|NCT01887600|141709234|SUPERIORITY||Least squares mean difference|1.987|||<|0.001|TWO_SIDED|95.0|1.79|2.19||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 16. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.19|1.79|<0.001
70998249|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|0.87||||0.2514|TWO_SIDED|95.0|0.73|1.04||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.04|0.73|0.2514
70998250|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|1.0||||0.9872|TWO_SIDED|95.0|0.84|1.19||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.19|0.84|0.9872
71100285|NCT01887600|141709234|SUPERIORITY||Least squares mean difference|1.841|||<|0.001|TWO_SIDED|95.0|1.64|2.05||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 18. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.05|1.64|<0.001
70998251|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.2582|TWO_SIDED|95.0|0.73|1.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.00|0.73|0.2582
70998252|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|1.06||||0.7918|TWO_SIDED|95.0|0.91|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.91|0.7918
70998253|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|0.86||||0.2514|TWO_SIDED|95.0|0.74|1.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.00|0.74|0.2514
70998254|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.9765|TWO_SIDED|95.0|0.88|1.2||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.20|0.88|0.9765
70998255|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|1.06||||0.6915|TWO_SIDED|95.0|0.86|1.3||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.30|0.86|0.6915
70998256|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|1.13||||0.7918|TWO_SIDED|95.0|0.93|1.38||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.38|0.93|0.7918
70998257|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.6922|TWO_SIDED|95.0|0.78|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.78|0.6922
70998258|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|1.01||||0.9872|TWO_SIDED|95.0|0.83|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.83|0.9872
70998259|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.3609|TWO_SIDED|95.0|0.7|1.04||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.04|0.70|0.3609
70998260|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|1.08||||0.7918|TWO_SIDED|95.0|0.89|1.3||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.30|0.89|0.7918
70998261|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|0.86||||0.2514|TWO_SIDED|95.0|0.71|1.05||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.05|0.71|0.2514
70998262|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.9765|TWO_SIDED|95.0|0.86|1.26||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.26|0.86|0.9765
70998263|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.6304|TWO_SIDED|95.0|0.79|1.08||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.08|0.79|0.6304
70998264|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|1.06||||0.7918|TWO_SIDED|95.0|0.91|1.24||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.24|0.91|0.7918
70998265|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|0.88||||0.2514|TWO_SIDED|95.0|0.75|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.03|0.75|0.2514
71041369|NCT04269993|141591331|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.04|TWO_SIDED||||||t-test, 1 sided|||||||0.04
71041370|NCT01067521|141591349|SUPERIORITY||Risk Ratio (RR)|0.656|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|0.539|0.799||The overall significance level for this study is 5%|Negative Binomial Regression||GA 40 mg vs. placebo|"Relapses were estimated by a baseline-adjusted, Negative Binomial Regression with an offset based on the log of subject's exposure to treatment. The model included the following covariates: - Baseline EDSS score. - Log of the prior 2-year number of relapses. - Volume of T2 lesions at baseliner. - Status of Gd-enhancing T1 activity at baseline (=0 no Gd-enhancing T1 at baseline; =1 at least one Gd-enhancing T1 at baseline). - CGR."||0.799|0.539|<0.0001
71041371|NCT01067521|141591350|SUPERIORITY||Risk Ratio (RR)|0.653|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|95.0|0.546|0.78||The overall significance level for this study is 5%|Negative binomial regression||GA 40 mg vs. placebo|Negative binomial regression||0.780|0.546|<.0001
71041372|NCT01067521|141591351|SUPERIORITY||Risk Ratio (RR)|0.552|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|0.436|0.699||The overall significance level for this study is 5%|Negative Binomial Regression||GA 40 mg vs. placebo|||0.699|0.436|<0.0001
71041373|NCT01067521|141591352|SUPERIORITY||Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.048||0.2058|TWO_SIDED|95.0|-0.154|0.033||The overall significance level for this study is 5%|ANCOVA||GA 40 mg vs Placebo|||0.033|-0.154|0.2058
71041374|NCT01067521|141591353|SUPERIORITY||Risk Ratio (RR)|0.8332|STANDARD_ERROR_OF_MEAN|0.0744||0.0409|TWO_SIDED|95.0|0.6995|0.9925||not adjusted for multiplicity|Negative Binomial Regression||Early Start vs Delayed Start|Entire Study The Negative Binomial Regression model covariates: • treatment group • PCBL (Placebo-Controlled Baseline) Kurtzke's Expanded Disability Status Scale (EDSS) score as 1 degree of freedom variable • Log of the # of relapses in the 2 years prior to PCBL • Volume of T2 lesions at PCBL • Status of Gd-enhancing T1 lesion activity at PCBL (=0 if no Gd-enhancing T1 lesions at PCBL; =1 if at least one Gd-enhancing T1 lesion at PCBL) • Country or Geographical Region (CGR)||0.9925|0.6995|0.0409
71041375|NCT01067521|141591354|SUPERIORITY||Risk Ratio (RR)|0.736|STANDARD_ERROR_OF_MEAN|0.081||0.0056|TWO_SIDED|95.0|0.592|0.914||not adjusted for multiplicity|Negative binomial regression||Early Start vs Delayed Start|Month 6 Negative binomial regression||0.914|0.592|0.0056
71041376|NCT01067521|141591354|SUPERIORITY||Risk Ratio (RR)|0.633|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001|TWO_SIDED|95.0|0.524|0.765||not adjusted for multiplicity|Negative binomial regression||Early Start vs Delayed Start|Month 12 Negative binomial regression||0.765|0.524|<0.0001
71041377|NCT01067521|141591354|SUPERIORITY||Risk Ratio (RR)|0.666|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001|TWO_SIDED|95.0|0.557|0.797||not adjusted for multiplicity|Negative binomial regression||Early Start vs Delayed Start|Month 36 Negative binomial regression||0.797|0.557|<0.0001
71100286|NCT01887600|141709234|SUPERIORITY||Least squares mean difference|1.824|||<|0.001|TWO_SIDED|95.0|1.61|2.04||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 20. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.04|1.61|<0.001
71100287|NCT01887600|141709234|SUPERIORITY||Least squares mean difference|1.651|||<|0.001|TWO_SIDED|95.0|1.43|1.87||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 22. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit.The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.87|1.43|<0.001
71100288|NCT01887600|141709234|SUPERIORITY||Least squares mean difference|1.447|||<|0.001|TWO_SIDED|95.0|1.23|1.67||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 24. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.67|1.23|<0.001
71041378|NCT01067521|141591355|SUPERIORITY||Risk Ratio (RR)|0.556|STANDARD_ERROR_OF_MEAN|0.093||0.0005|TWO_SIDED|95.0|0.4|0.773||not adjusted for multiplicity|Negative Binomial Regression||Early Start vs Delayed Start|Month 6||0.773|0.4|0.0005
71041379|NCT01067521|141591355|SUPERIORITY||Risk Ratio (RR)|0.514|STANDARD_ERROR_OF_MEAN|0.073|<|0.0001|TWO_SIDED|95.0|0.388|0.679||not adjusted for multiplicity|Negative binomial regression||Early Start vs Delayed Start|Month 12||0.679|0.388|<0.0001
71041380|NCT01067521|141591355|SUPERIORITY||Risk Ratio (RR)|0.663|STANDARD_ERROR_OF_MEAN|0.086||0.0015|TWO_SIDED|95.0|0.514|0.854||not adjusted for multiplicity|Negative binomial regression||Early Start vs Delayed Start|Month 36||0.854|0.514|0.0015
71041381|NCT01067521|141591356|SUPERIORITY||Mean Difference (Final Values)|-0.084|STANDARD_ERROR_OF_MEAN|0.041||0.0425|TWO_SIDED|95.0|-0.166|-0.003||not adjusted for multiplicity|Mixed model for repeated measures (MMRM)||Early Start vs Delayed Start|Month 6||-0.003|-0.166|0.0425
71041382|NCT01067521|141591356|SUPERIORITY||Mean Difference (Final Values)|-0.086|STANDARD_ERROR_OF_MEAN|0.05||0.0844|TWO_SIDED|95.0|-0.184|0.012||not adjusted for multiplicity|Mixed model for repeated measures (MMRM)||Early Start vs Delayed Start|Month 12||0.012|-0.184|0.0844
71041383|NCT01067521|141591356|SUPERIORITY||Mean Difference (Final Values)|0.017|STANDARD_ERROR_OF_MEAN|0.106||0.8701|TWO_SIDED|95.0|-0.91|0.225||not adjusted for multiplicity|Mixed model for repeated measures (MMRM)||Early Start vs Delayed Start|Month 36||0.225|-0.91|0.8701
71100289|NCT01887600|141709234|SUPERIORITY||Least squares mean difference|1.561|||<|0.001|TWO_SIDED|95.0|1.34|1.78||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 28. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.78|1.34|<0.001
71100290|NCT01887600|141709234|SUPERIORITY||Least squares mean difference|1.587|||<|0.001|TWO_SIDED|95.0|1.37|1.81||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change From BL to week 32. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.81|1.37|<0.001
71041384|NCT00452543|141591359|NON_INFERIORITY_OR_EQUIVALENCE|This was a test of non-inferiority between the effects of acamprosate vs. placebo. Power analysis was originally based on ITT analysis with 40 subjects, and assumed 30% difference in alcohol consumption (50% vs. 20% reduction in the acamprosate and placebo groups, respectively). With alpha of 0.05, we estimated 74% power to detect a difference between the two groups. Results would be used to estimate effect size to set the stage for an adequately powered larger study in the future.|||||<|0.05||95.0||||Threshold for significance was set a priori at p\<0.05.|Wilcoxon (Mann-Whitney)|||Statistical analyses evaluated the null hypothesis that there would be no difference in the effect of acamprosate vs. placebo on total drinking days.Power analysis was originally based on ITT analysis with 40 subjects, and assumed 30% difference in alcohol consumption (50% vs. 20% reduction in the acamprosate and placebo groups, respectively). With alpha of 0.05, we estimated 74% power to detect a difference between the two groups.||||<0.05
71041385|NCT00452543|141591360|NON_INFERIORITY_OR_EQUIVALENCE|This was a test of non-inferiority between the effects of acamprosate vs. placebo.|||||<|0.05||95.0||||This p \<0.05 was set a priori.|Wilcoxon (Mann-Whitney)|||Statistical analyses evaluated the null hypothesis that there would be no difference in the effect of acamprosate vs. placebo on total drinks consumed per week.Power analysis was originally based on ITT analysis with 40 subjects, and assumed 30% difference in alcohol consumption (50% vs. 20% reduction in the acamprosate and placebo groups, respectively). With alpha of 0.05, we estimated 74% power to detect a difference between the two groups.||||<0.05
71041386|NCT00452543|141591361|NON_INFERIORITY_OR_EQUIVALENCE|"This was a test of non-inferiority between the effects of acamprosate vs. placebo. Statistical analyses evaluated the null hypothesis that there would be no difference in the effect of acamprosate vs. placebo on total drinks consumed per drinking day.~Power analysis is discussed above."|||||<|0.05||95.0||||This p\<0.05 was set a priori.|Wilcoxon (Mann-Whitney)|||"Statistical analyses evaluated the null hypothesis that there would be no difference in the effect of acamprosate vs. placebo on total drinks consumed per drinking day.~Power analysis was originally based on ITT analysis with 40 subjects, and assumed 30% difference in alcohol consumption (50% vs. 20% reduction in the acamprosate and placebo groups, respectively). With alpha of 0.05, we estimated 74% power to detect a difference between the two groups."||||<0.05
71041387|NCT01098539|141591380|NON_INFERIORITY_OR_EQUIVALENCE|The p-value was from a 1-sided t test to test whether the difference of LS means (albiglutide - sitagliptin) was less than or equal to the prespecified noninferiority margin of 0.4%.|Median Difference (Final Values)|-0.32|||<|0.0001|TWO_SIDED|95.0|-0.49|-0.15|||t-test, 1 sided|||||-0.15|-0.49|<0.0001
71041388|NCT01849458|141591397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.6|STANDARD_DEVIATION|26.0||0.0001|TWO_SIDED|95.0|25.2|40.0|||2-sided, paired t-test|||Difference from baseline (6M-Baseline)||40|25.2|0.0001
71041389|NCT01849458|141591398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.7|STANDARD_DEVIATION|23.6||0.0001|TWO_SIDED|95.0|28.7|42.7|||2-sided, paired t-test|||Difference from baseline (12M-Baseline)||42.7|28.7|0.0001
71041390|NCT01849458|141591399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.8|STANDARD_DEVIATION|22.2||0.0001|TWO_SIDED|95.0|37.4|50.1|||2-sided, paired t-test|||Difference from baseline (6M-Baseline)||50.1|37.4|0.0001
71041391|NCT01849458|141591400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.2|STANDARD_DEVIATION|20.2||0.0001|TWO_SIDED|95.0|43.2|55.2|||2-sided, paired t-test|||Difference from baseline (12M-Baseline)||55.2|43.2|0.0001
71041392|NCT02174276|141591415|SUPERIORITY|Estimated differences in treatment effects between GS-4774 treatment groups and the TDF only group at Week 24 are presented with the 95% CIs and unadjusted P-values.|Least Square Mean Difference|-0.017||||0.805|TWO_SIDED|95.0|-0.155|0.12|||Mixed-Effect Model for Repeated Measures|||The null hypotheses was that the mean change from baseline in serum HBsAg in each of the TDF + GS-4774 groups was equal to the mean change from baseline in serum HBsAg in the TDF only group. Each null hypothesis was tested against the 2-sided alternative hypothesis that the mean change from baseline in serum HBsAg was not equal between each of the respective GS-4774 dose groups and the TDF only group.||0.120|-0.155|0.805
71041393|NCT02174276|141591415|SUPERIORITY|Estimated differences in treatment effects between GS-4774 treatment groups and the TDF only group at Week 24 are presented with the 95% CIs and unadjusted P-values.|Least Square Mean Difference|0.063||||0.37|TWO_SIDED|95.0|-0.075|0.202|||Mixed-Effect Model for Repeated Measures|||The null hypotheses was that the mean change from baseline in serum HBsAg in each of the TDF + GS-4774 groups was equal to the mean change from baseline in serum HBsAg in the TDF only group. Each null hypothesis was tested against the 2-sided alternative hypothesis that the mean change from baseline in serum HBsAg was not equal between each of the respective GS-4774 dose groups and the TDF only group.||0.202|-0.075|0.370
71041394|NCT02174276|141591415|SUPERIORITY|Estimated differences in treatment effects between GS-4774 treatment groups and the TDF only group at Week 24 are presented with the 95% CIs and unadjusted P-values.|Least Square Mean Difference|-0.056||||0.426|TWO_SIDED|95.0|-0.194|0.082|||Mixed-Effect Model for Repeated Measures|||The null hypotheses was that the mean change from baseline in serum HBsAg in each of the TDF + GS-4774 groups was equal to the mean change from baseline in serum HBsAg in the TDF only group. Each null hypothesis was tested against the 2-sided alternative hypothesis that the mean change from baseline in serum HBsAg was not equal between each of the respective GS-4774 dose groups and the TDF only group.||0.082|-0.194|0.426
71041395|NCT00781079|141591436|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|||||Models included site, age, race, ethnicity.|Regression, Linear|||comparisons between the PS and Usual Care groups were completed with a regression testing the interaction of group (PS vs Usual Care) and time (baseline vs follow-up) for the outcome measure. The measure was analyzed with mixed effect hierarchical regressions which accounted for the nesting of site under treatment, subjects within sites, and subjects over time.||||.5
71041396|NCT00781079|141591437|SUPERIORITY||Z tests if Reg coeff are diff from 0|-0.58||||0.56|TWO_SIDED||||||Regression, Linear|||||||.56
71041397|NCT00781079|141591438|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|||||Models included site, age, race, ethnicity. This is the calculated p value.|Regression, Linear|||comparisons between the PS and Usual Care groups were completed with a regression testing the interaction of group (PS vs Usual Care) and time (baseline vs follow-up) for the outcome measure. The measure was analyzed with mixed effect hierarchical regressions which accounted for the nesting of site under treatment, subjects within sites, and subjects over time.||||.05
71041398|NCT00781079|141591439|SUPERIORITY||Z test if reg coeff is diff from 0|0.56||||0.58|TWO_SIDED||||||Regression, Linear|||||||.58
71041399|NCT00781079|141591440|SUPERIORITY||Z test if reg coeff is diff than 0|-0.16||||0.87|TWO_SIDED||||||Regression, Linear|||||||.87
71041400|NCT00781079|141591441|SUPERIORITY||Z test if ref coeff is diff than 0|0.03||||0.98|TWO_SIDED||||||Regression, Linear|||||||.98
71041401|NCT02786927|141591461|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71041402|NCT02786927|141591462|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71041403|NCT02786927|141591463|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71041404|NCT01801917|141591464|SUPERIORITY_OR_OTHER_LEGACY||Bayesian|0.586||||||||||||||It was a Bayesian analysis with non-informative prior for co-primary endpoints, MMT-24 and CK, with dual criteria for statistical significance: ≥ 90% posterior probability (PP) of achieving an increase from baseline in MMT24 and decrease in CK and clinical relevance: ≥ 50% PP achieving an increase of 15 points in MMT24 and a decrease of 30% in CK vs. placebo. For this table the value is the posterior probability of achieving an increase in MMT24 and a decrease in CK in 2mg group vs. placebo||||
71041405|NCT01801917|141591464|SUPERIORITY_OR_OTHER_LEGACY||Bayesian|0.022||||||||||||||It was a Bayesian analysis with non-informative prior for co-primary endpoints, MMT-24 and CK, with dual criteria for statistical significance: ≥ 90% posterior probability (PP) of achieving an increase from baseline in MMT24 and decrease in CK and clinical relevance: ≥ 50% PP achieving an increase of 15 points in MMT24 and a decrease of 30% in CK vs. placebo. . For this table the value is the PP of achieving an increase of 15 points in MMT24 and a decrease of 30% in CK in 2mg group vs. placebo||||
71041406|NCT01801917|141591464|SUPERIORITY_OR_OTHER_LEGACY||Bayesian|0.963||||||||||||||It was a Bayesian analysis with non-informative prior for co-primary endpoints, MMT-24 and CK, with dual criteria for statistical significance: ≥ 90% posterior probability (PP) of achieving an increase from baseline in MMT24 and decrease in CK and clinical relevance: ≥ 50% PP achieving an increase of 15 points in MMT24 and a decrease of 30% in CK vs. placebo. For this table the value is the posterior probability of achieving an increase in MMT24 and a decrease in CK in 10mg group vs. placebo||||
71041407|NCT01801917|141591464|SUPERIORITY_OR_OTHER_LEGACY||Bayesian|0.837||||||||||||||It was a Bayesian analysis with non-informative prior for co-primary endpoints, MMT-24 and CK, with dual criteria for statistical significance: ≥ 90% posterior probability (PP) of achieving an increase from baseline in MMT24 and decrease in CK and clinical relevance: ≥ 50% PP achieving an increase of 15 points in MMT24 and a decrease of 30% in CK vs. placebo. . For this table the value is the PP of achieving an increase of 15 points in MMT24 and a decrease of 30% in CK in 10mg group vs. placebo||||
71041408|NCT04381481|141591483|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Logistic|||beverages with claim compared to control beverage||||<0.001
71041409|NCT04381481|141591484|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Logistic|||snacks with warning compared to control snack||||<0.001
71041410|NCT04381481|141591485|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Logistic|||beverages with claim compared to control beverage||||<0.001
71041411|NCT04381481|141591486|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Logistic|||beverages with claim compared to control beverage||||<0.001
71041412|NCT04381481|141591487|SUPERIORITY||||||<|0.01||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||Beverages with claim compared to control beverage||||<0.01
71041413|NCT04381481|141591488|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
71041414|NCT04381481|141591489|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
71041415|NCT04381481|141591490|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
71041416|NCT04381481|141591491|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
71041417|NCT04381481|141591492|SUPERIORITY||||||<|0.01||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Logistic|||beverages with claim compared to control beverage||||<0.01
71041418|NCT04381481|141591493|SUPERIORITY||||||<|0.01||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.01
71041419|NCT04381481|141591494|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
71041420|NCT04381481|141591495|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
71041421|NCT04381481|141591496|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
71041422|NCT04381481|141591497|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
71041423|NCT04381481|141591498|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
71041424|NCT04381481|141591499|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
71041425|NCT04381481|141591500|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
71041426|NCT04381481|141591501|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
71041427|NCT04381481|141591502|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
71041428|NCT04381481|141591503|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
71041429|NCT04381481|141591504|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
70998266|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.9765|TWO_SIDED|95.0|0.88|1.2||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.20|0.88|0.9765
70998267|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|0.84||||0.2582|TWO_SIDED|95.0|0.71|1.01||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.01|0.71|0.2582
70998268|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|0.99||||0.9279|TWO_SIDED|95.0|0.84|1.18||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.18|0.84|0.9279
70998269|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.2514|TWO_SIDED|95.0|0.72|1.01||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.01|0.72|0.2514
70998270|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.9765|TWO_SIDED|95.0|0.76|1.07||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.07|0.76|0.9765
70998271|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|0.82||||0.1424|TWO_SIDED|95.0|0.71|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.96|0.71|0.1424
70998272|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|0.97||||0.7918|TWO_SIDED|95.0|0.84|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.84|0.7918
70998273|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.2514|TWO_SIDED|95.0|0.73|0.98||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.98|0.73|0.2514
70998274|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.9765|TWO_SIDED|95.0|0.79|1.07||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.07|0.79|0.9765
70998275|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|0.93||||0.6304|TWO_SIDED|95.0|0.78|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.78|0.6304
70998276|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.7918|TWO_SIDED|95.0|0.88|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.88|0.7918
70998277|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.6922|TWO_SIDED|95.0|0.81|1.13||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.13|0.81|0.6922
70998278|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|0.97||||0.9765|TWO_SIDED|95.0|0.82|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.82|0.9765
70998279|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.6572|TWO_SIDED|95.0|0.84|1.08||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.08|0.84|0.6572
70998280|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|0.98||||0.7918|TWO_SIDED|95.0|0.86|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.86|0.7918
70998281|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|0.89||||0.2514|TWO_SIDED|95.0|0.79|1.01||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.01|0.79|0.2514
70998282|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|1.0||||0.9872|TWO_SIDED|95.0|0.88|1.13||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.13|0.88|0.9872
70998283|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.6304|TWO_SIDED|95.0|0.78|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.09|0.78|0.6304
70998284|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.7918|TWO_SIDED|95.0|0.88|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.88|0.7918
70998285|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.6922|TWO_SIDED|95.0|0.8|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.80|0.6922
70998286|NCT01392378|141503823|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.9765|TWO_SIDED|95.0|0.81|1.13||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.13|0.81|0.9765
70998287|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|1.2||||0.7148|TWO_SIDED|95.0|0.82|1.66||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.66|0.82|0.7148
70998288|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|1.0||||0.7907|TWO_SIDED|95.0|0.75|1.45||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.45|0.75|0.7907
70998289|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.4765|TWO_SIDED|95.0|0.81|1.6||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.60|0.81|0.4765
70998290|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|1.3||||0.5037|TWO_SIDED|95.0|0.89|1.76||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.76|0.89|0.5037
71041430|NCT04381481|141591505|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
71100291|NCT01887600|141709234|SUPERIORITY||Least squares mean difference|1.69|||<|0.001|TWO_SIDED|95.0|1.46|1.92||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb Change from BL to week 36. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit.The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.92|1.46|<0.001
70998291|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.9414|TWO_SIDED|95.0|0.52|2.17||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||2.17|0.52|0.9414
70998292|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.7907|TWO_SIDED|95.0|0.45|1.71||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.71|0.45|0.7907
71041431|NCT04381481|141591506|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
71041432|NCT04381481|141591507|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
71041433|NCT04381481|141591508|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
71041434|NCT04381481|141591509|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
70998293|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.6||||0.29|TWO_SIDED|95.0|0.32|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.32|0.2900
70998294|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.8826|TWO_SIDED|95.0|0.44|1.77||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.77|0.44|0.8826
70998295|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.5||||0.5823|TWO_SIDED|95.0|0.18|1.4||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.40|0.18|0.5823
70998296|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.7636|TWO_SIDED|95.0|0.27|1.8||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.80|0.27|0.7636
70998297|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.4||||0.2407|TWO_SIDED|95.0|0.14|1.05||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.05|0.14|0.2407
71041435|NCT04381481|141591510|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
71041436|NCT00420095|141591547|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority hypothesis testing where paired t-test for equivalence of means was used to estimate the sample size.~Pre-defined non-inferiority margin of 0.3%."|Mean Difference (Net)|-0.05||||0.497||95.0|-0.2|0.1|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate the denominator degrees of freedom. Adjusted means were presented.||Mixed model where period, sequence, treatment are fixed effects and patient within sequence are random effects.||0.10|-0.20|0.497
71041437|NCT00420095|141591548|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.497||95.0|-0.1|0.2||All comparisons were conducted using a 2-sided significance level of 0.05.|Mixed Models Analysis|Adjusted means||||0.20|-0.10|0.497
71041438|NCT00420095|141591549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.419||95.0|-0.48|0.2||All comparisons were conducted using a 2-sided significance level of 0.05.|Mixed Models Analysis|Adjusted means||||0.20|-0.48|0.419
71041439|NCT00420095|141591550|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16||||0.741||95.0|-1.09|0.78||All comparisons were conducted using a 2-sided significance level of 0.05.|Mixed Models Analysis|Adjusted means||||0.78|-1.09|0.741
71041440|NCT00420095|141591551|SUPERIORITY_OR_OTHER|||||||0.644||95.0||||P-value for the HbA1c Percentage Criteria (7%)|Fisher Exact|||||||0.644
70998298|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|1.2||||0.8826|TWO_SIDED|95.0|0.43|3.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||3.22|0.43|0.8826
70998299|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.5||||0.0961|TWO_SIDED|95.0|0.26|0.81||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.81|0.26|0.0961
70998300|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.7636|TWO_SIDED|95.0|0.38|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.38|0.7636
71041441|NCT00420095|141591551|SUPERIORITY_OR_OTHER|||||||0.672||95.0||||P-value for the HbA1c Percentage Criteria (6.5%)|Fisher Exact|||||||0.672
71041442|NCT00420095|141591553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.67||95.0|-0.16|0.11||All comparisons were conducted using a 2-sided significance level of 0.05.|Mixed Models Analysis|Adjusted means||||0.11|-0.16|0.670
71041443|NCT01634854|141591558|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
71041444|NCT00578968|141591579|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|||||||0.01
71041445|NCT00578968|141591580|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71041446|NCT00578968|141591581|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71041447|NCT00578968|141591582|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71041448|NCT00578968|141591583|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||ANOVA|||Comparison between the two groups at baseline resting.||||0.13
71041449|NCT00578968|141591583|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANOVA|||Comparison was made between the two groups at baseline peak exercise||||<0.01
71041450|NCT00578968|141591584|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71041451|NCT00578968|141591585|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
71041452|NCT00578968|141591586|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||ANOVA|||||||0.15
71041453|NCT00578968|141591587|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|||||||0.01
71041454|NCT00578968|141591588|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANOVA|||||||0.85
71041455|NCT00578968|141591589|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANOVA|||||||0.03
71041456|NCT00578968|141591590|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANOVA|||||||0.009
71041457|NCT00578968|141591591|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANOVA|||||||0.005
71041458|NCT00578968|141591592|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||ANOVA|||||||0.06
71041459|NCT00578968|141591593|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANOVA|||||||0.003
70998301|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.29|TWO_SIDED|95.0|0.39|1.19||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.19|0.39|0.2900
70998302|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|1.0||||0.8826|TWO_SIDED|95.0|0.6|1.82||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.82|0.60|0.8826
70998303|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|1.0||||0.9925|TWO_SIDED|95.0|0.65|1.54||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.54|0.65|0.9925
70998304|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.7636|TWO_SIDED|95.0|0.52|1.17||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.17|0.52|0.7636
70998305|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.3929|TWO_SIDED|95.0|0.53|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.53|0.3929
70998306|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.8826|TWO_SIDED|95.0|0.62|1.43||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.43|0.62|0.8826
70998307|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|1.2||||0.7433|TWO_SIDED|95.0|0.7|2.2||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||2.20|0.70|0.7433
70998308|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.7636|TWO_SIDED|95.0|0.46|1.35||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.35|0.46|0.7636
70998309|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.6||||0.2407|TWO_SIDED|95.0|0.34|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.03|0.34|0.2407
70998310|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.8826|TWO_SIDED|95.0|0.61|1.83||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.83|0.61|0.8826
70998311|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.9414|TWO_SIDED|95.0|0.51|1.71||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.71|0.51|0.9414
71041460|NCT00578968|141591594|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||ANOVA|||||||0.60
71041461|NCT00578968|141591595|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANOVA|||||||0.35
71041462|NCT00578968|141591596|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||ANOVA|||||||0.65
71041463|NCT00578968|141591597|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||ANOVA|||||||0.43
71041464|NCT00578968|141591598|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||ANOVA|||Comparison was made between groups at pretreatment resting time period.||||0.73
71041465|NCT00578968|141591598|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANOVA|||Comparison was made between groups at pretreatment peak exercise time period.||||0.11
71041466|NCT00578968|141591599|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANOVA|||||||0.22
71041467|NCT00578968|141591600|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||ANOVA|||||||0.06
71041468|NCT00578968|141591601|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||ANOVA|||||||0.09
71041469|NCT00578968|141591602|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||||||0.04
71041470|NCT00578968|141591603|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||||||0.04
71041471|NCT00578968|141591604|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||ANOVA|||||||0.19
71041472|NCT00578968|141591605|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||||||0.16
71041473|NCT00578968|141591606|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||||||0.04
71041474|NCT03429049|141591623|SUPERIORITY||Least Squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.256||0.1904|TWO_SIDED|95.0|-0.84|0.17|||Mixed Models Analysis|||The NRS least squares mean difference in change from baseline between treatment arms was analyzed with a mixed model for repeated measures (MMRM). It included terms for treatment, pooled study center, baseline K L grade category for the index knee, baseline BMI category, sex, study week, treatment by visit study week interaction, and baseline average daily pain with walking NPRS (0-10) score as covariates, using an unstructured covariance structure.||0.17|-0.84|0.1904
70998312|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|1.2||||0.7636|TWO_SIDED|95.0|0.68|2.14||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||2.14|0.68|0.7636
70998313|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.738|TWO_SIDED|95.0|0.5|1.63||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.63|0.50|0.7380
70998314|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.8826|TWO_SIDED|95.0|0.49|1.58||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.58|0.49|0.8826
70998315|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.9414|TWO_SIDED|95.0|0.67|1.65||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.65|0.67|0.9414
70998316|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.7907|TWO_SIDED|95.0|0.58|1.43||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.43|0.58|0.7907
70998317|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.2407|TWO_SIDED|95.0|0.43|1.04||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.04|0.43|0.2407
70998318|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.267|TWO_SIDED|95.0|0.42|1.02||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.02|0.42|0.2670
70998319|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.5823|TWO_SIDED|95.0|0.62|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.62|0.5823
70998320|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.7636|TWO_SIDED|95.0|0.65|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.16|0.65|0.7636
70998321|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.6||||0.0422|TWO_SIDED|95.0|0.48|0.86||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.86|0.48|0.0422
70998322|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.267|TWO_SIDED|95.0|0.53|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.96|0.53|0.2670
70998323|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.8454|TWO_SIDED|95.0|0.72|1.78||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.78|0.72|0.8454
70998324|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|1.3||||0.7636|TWO_SIDED|95.0|0.81|2.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||2.00|0.81|0.7636
70998325|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.2824|TWO_SIDED|95.0|0.45|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.45|0.2824
70998326|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|1.3||||0.5155|TWO_SIDED|95.0|0.83|2.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||2.06|0.83|0.5155
70998327|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.5823|TWO_SIDED|95.0|0.5|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.50|0.5823
71041475|NCT03429049|141591624|SUPERIORITY||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|1.206||0.0257|TWO_SIDED|95.0|-5.07|-0.33|||Mixed Models Analysis|||The WOMAC A least squares mean difference in change from baseline between treatment arms was analyzed with a mixed model for repeated measures (MMRM). It included terms for treatment, pooled study center, baseline K L grade category for the index knee, baseline BMI category, sex, study week, treatment by visit study week interaction, and baseline average daily pain with walking NPRS (0-10) score as covariates, using an unstructured covariance structure.||-0.33|-5.07|0.0257
71041476|NCT03429049|141591625|SUPERIORITY||Least Squares Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.545||0.0855|TWO_SIDED|95.0|-2.01|0.13|||Mixed Models Analysis|||The WOMAC B least squares mean difference in change from baseline between treatment arms was analyzed with a mixed model for repeated measures (MMRM). It included terms for treatment, pooled study center, baseline K L grade category for the index knee, baseline BMI category, sex, study week, treatment by visit study week interaction, and baseline average daily pain with walking NPRS (0-10) score as covariates, using an unstructured covariance structure.||0.13|-2.01|0.0855
71041477|NCT03429049|141591626|SUPERIORITY||Mean Difference (Final Values)|-7.8|STANDARD_ERROR_OF_MEAN|4.096||0.055|TWO_SIDED|95.0|-15.86|0.26|||Mixed Models Analysis|||The WOMAC C least squares mean difference in change from baseline between treatment arms was analyzed with a mixed model for repeated measures (MMRM). It included terms for treatment, pooled study center, baseline K L grade category for the index knee, baseline BMI category, sex, study week, treatment by visit study week interaction, and baseline average daily pain with walking NPRS (0-10) score as covariates, using an unstructured covariance structure.||0.26|-15.86|0.0550
70998328|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.7636|TWO_SIDED|95.0|0.78|1.7||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.70|0.78|0.7636
70998329|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.4644|TWO_SIDED|95.0|0.56|1.25||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.25|0.56|0.4644
70998330|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.8826|TWO_SIDED|95.0|0.59|1.31||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.31|0.59|0.8826
71041478|NCT01503333|141591750|EQUIVALENCE|Linear mixed-effect models were applied to examine the intervention effect on MVPA at post-intervention. Models included the group variable, cluster random effect of school, and the following fixed effects: age, BMI z-score, race, SES, ethnicity, pubertal stage, and study year. Baseline MVPA was included when evaluating the intervention effect at post-intervention.|parameter estimate|-0.08||||0.207|TWO_SIDED|95.0|-0.21|0.05|||Mixed Models Analysis|||Hypotheses: Post-intervention, weighted mean minutes of MVPA/week will be greater by 16 minutes among girls in intervention than control schools. Mean minutes per week is determined by multiplying mean minutes/hour by 90 hours that girls are awake in a week (10 hours awake on each weekend day; 14 hours awake on each weekday).||0.05|-0.21|.207
71041479|NCT01503333|141591751|EQUIVALENCE|Linear mixed models were used to analyze intervention effect on CV fitness according to intention-to-treat, with school pairs treated as random effect and students nested within school and treatment condition. Models included main intervention predictor (control or intervention), incorporated cluster random effect, specified school pairs (random intercept), and controlled for baseline CV fitness, physical activity, race, socioeconomic status, ethnicity, pubertal stage, and study year cohort.|parameter estimate|0.2|STANDARD_ERROR_OF_MEAN|0.08||0.018|TWO_SIDED|95.0|0.03|0.36|||Mixed Models Analysis|||Immediately post-intervention, cardiovascular (CV) fitness will be higher among girls in the intervention than control schools.||0.36|0.03|.018
71041480|NCT01503333|141591752|OTHER|Linear mixed models were used to analyze intervention effect on BMI-z according to intention-to-treat, with school pairs treated as random effect and students nested within school and treatment condition. Models for BMI-z included main intervention predictor (control or intervention), incorporated cluster random effect, specified school pairs (random intercept), and controlled for baseline BMI-z, physical activity, race, socioeconomic status, ethnicity, pubertal stage, and study year cohort.|parameter estimate|-0.02|STANDARD_ERROR_OF_MEAN|0.01||0.191|TWO_SIDED|95.0|-0.05|0.01|||Mixed Models Analysis|||Immediately post-intervention, BMI z-score will be significantly lower among girls in the intervention than control schools.||0.01|-0.05|.191
71041481|NCT01503333|141591753|EQUIVALENCE|Linear mixed models were used to analyze intervention effect on % body fat according to intention-to-treat, with school pairs treated as random effect and students nested within school and treatment condition. Models included main intervention predictor (control or intervention), incorporated cluster random effect, specified school pairs (random intercept), and controlled for baseline % body fat, age, physical activity, race, socioeconomic status, ethnicity, pubertal stage, and year cohort.|parameter estimate|-0.37|STANDARD_ERROR_OF_MEAN|0.14||0.007|TWO_SIDED|95.0|-0.64|-0.1|||Mixed Models Analysis|||Immediately post-intervention, percent body fat will be significantly lower among girls in the intervention than control schools.||-0.10|-0.64|.007
71041482|NCT01503333|141591754|EQUIVALENCE|Linear mixed-effect models were applied to examine the intervention effect on MVPA at 9-month follow up. Models included the group variable, cluster random effect of school, and the following fixed effects: age, BMI z-score, race, SES, ethnicity, pubertal stage, and study year. Baseline MVPA was included when evaluating the intervention effect at follow up.|parameter estimate|-0.09||||0.118|TWO_SIDED|95.0|-0.21|0.02|||Mixed Models Analysis|||||0.02|-0.21|.118
70998331|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.5823|TWO_SIDED|95.0|0.61|1.13||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.13|0.61|0.5823
70998332|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.7636|TWO_SIDED|95.0|0.65|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.65|0.7636
70998333|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.3299|TWO_SIDED|95.0|0.6|1.13||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.13|0.60|0.3299
70998334|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.267|TWO_SIDED|95.0|0.54|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.03|0.54|0.2670
70998335|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.5823|TWO_SIDED|95.0|0.48|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.48|0.5823
70998336|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.7907|TWO_SIDED|95.0|0.68|1.69||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.69|0.68|0.7907
70998337|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.2742|TWO_SIDED|95.0|0.43|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.09|0.43|0.2742
70998338|NCT01392378|141503825|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.267|TWO_SIDED|95.0|0.42|1.05||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.05|0.42|0.2670
70998339|NCT01392378|141503826|SUPERIORITY_OR_OTHER||GMC Ratio|0.93||||0.813|TWO_SIDED|95.0|0.71|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.71|0.813
70998340|NCT01392378|141503826|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.845|TWO_SIDED|95.0|0.79|1.34||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.34|0.79|0.845
70998341|NCT01392378|141503826|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.461|TWO_SIDED|95.0|0.65|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.65|0.461
70998342|NCT01392378|141503826|SUPERIORITY_OR_OTHER||GMC Ratio|0.89||||0.545|TWO_SIDED|95.0|0.68|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.16|0.68|0.545
70998343|NCT01392378|141503827|SUPERIORITY_OR_OTHER||GMC Ratio|0.91||||0.712|TWO_SIDED|95.0|0.79|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.79|0.712
70998344|NCT01392378|141503827|SUPERIORITY_OR_OTHER||GMC Ratio|0.97||||0.837|TWO_SIDED|95.0|0.84|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.84|0.837
70998345|NCT01392378|141503827|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.357|TWO_SIDED|95.0|0.78|1.04||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.04|0.78|0.357
70998346|NCT01392378|141503827|SUPERIORITY_OR_OTHER||GMC Ratio|0.88||||0.19|TWO_SIDED|95.0|0.76|1.01||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.01|0.76|0.190
71041483|NCT01503333|141591755|OTHER||parameter estimate|-0.97|||||TWO_SIDED|||||||||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-square test p\>.05.26.||||
70998347|NCT01392378|141503827|SUPERIORITY_OR_OTHER||GMC Ratio|0.96||||0.813|TWO_SIDED|95.0|0.83|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.83|0.813
70998348|NCT01392378|141503827|SUPERIORITY_OR_OTHER||GMC Ratio|0.84||||0.136|TWO_SIDED|95.0|0.73|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.96|0.73|0.136
70998349|NCT01392378|141503827|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.104|TWO_SIDED|95.0|0.74|0.98||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.98|0.74|0.104
70998350|NCT01392378|141503827|SUPERIORITY_OR_OTHER||GMC Ratio|0.73|||<|0.001|TWO_SIDED|95.0|0.64|0.85||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.85|0.64|<0.001
70998351|NCT01392378|141503827|SUPERIORITY_OR_OTHER||GMC Ratio|0.86||||0.712|TWO_SIDED|95.0|0.72|1.04||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.04|0.72|0.712
70998352|NCT01392378|141503827|SUPERIORITY_OR_OTHER||GMC Ratio|0.84||||0.206|TWO_SIDED|95.0|0.7|1.01||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.01|0.70|0.206
71041484|NCT01503333|141591756|OTHER||parameter estimate|2.9|||||TWO_SIDED|||||||||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squar||||
71041485|NCT01503333|141591757|OTHER||parameter estimate|0.47|||||TWO_SIDED|||||||||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squar||||
71041486|NCT01503333|141591758|OTHER||parameter estimate|30.48|||<|0.001|TWO_SIDED||||||Path analysis|||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squar||||<.001
71041487|NCT01503333|141591759|OTHER||parameter estimate|24.48|||<|0.001|TWO_SIDED||||||Path analysis|||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squar||||<.001
71041488|NCT01503333|141591760|OTHER||parameter estimate|3.19|||||TWO_SIDED|||||||||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squar||||
71041489|NCT00996437|141591798|SUPERIORITY_OR_OTHER||Treatment Difference in Cumulative Prob|4.0||||0.37|TWO_SIDED|95.0|-4.0|13.0|||Log Rank|After adjusting for potential confounding factors, time to vitrectomy remained similar between treatment groups.||The cumulative probabilities of vitrectomy by 16 weeks in each group were computed using the life-table method. Treatment group comparisons were performed using the log-rank test. The treatment difference in cumulative probabilities and 95% confidence interval were reported.||13|-4|0.37
71041490|NCT00996437|141591799|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value corresponds with recurrent vitreous hemorrhage evaluated on clinical exam between the two treatment arms.|Fisher Exact|||||||0.01
70998353|NCT01392378|141503827|SUPERIORITY_OR_OTHER||GMC Ratio|0.78||||0.066|TWO_SIDED|95.0|0.65|0.93||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.93|0.65|0.066
71041491|NCT00996437|141591800|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.54||||0.05|TWO_SIDED|95.0|1.03|2.3|||Log Rank|||||2.30|1.03|0.05
71041492|NCT00996437|141591801|SUPERIORITY_OR_OTHER|||||||0.87||95.0||||P-value corresponds to the 12 week visit treatment comparison.|GLM with GEE method|Number of subjects with baseline OCT ss=0 and OCT ss\>0 and no vitrectomy at follow up. A generalized GLM with GEE was used for treatment comparisons.||Signal strength was analyzed as a composite outcome defined as OCT signal strength \> = and no vitrectomy vs. OCT signal strength = 0.||||0.87
71041493|NCT00996437|141591802|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||P-value corresponds to the 12 week visit treatment comparison.|Mixed Models Analysis|Treatment comparisons were performed using a longitudinal mixed model adjusting for baseline visual acuity.||||||.04
70998354|NCT01392378|141503827|SUPERIORITY_OR_OTHER||GMC Ratio|0.81||||0.085|TWO_SIDED|95.0|0.67|0.97||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.97|0.67|0.085
71041494|NCT00996437|141591804|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value corresponds with the 12 week visit treatment comparison|Fisher Exact|At the each time point, treatment comparison analysis was performed using a Fisher Exact test.||||||.023
70998355|NCT01392378|141503828|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.712|TWO_SIDED|95.0|0.77|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.77|0.712
70923883|NCT01820260|141339731|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|TWO_SIDED|||||To account for multiple testing, the 4 pairwise tests with corresponding vehicle group were performed using Bonferroni method testing at a 1.25% significance level, securing that the overall significance level did not exceed 5%|Fisher Exact|||Complete clearance of AKs at Week 8 was to be analysed by log binomial regression with factors treatment group, anatomical location (face/chest or scalp) and analysis site. Due to the low numbers of subjects obtaining complete clearance in the vehicle groups,the proposed model did not converge and Fisher's exact test was used instead to compare active treatments with the respective vehicle arm.||||0.0002
70998356|NCT01392378|141503828|SUPERIORITY_OR_OTHER||GMC Ratio|0.86||||0.206|TWO_SIDED|95.0|0.74|1.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.00|0.74|0.206
70998357|NCT01392378|141503828|SUPERIORITY_OR_OTHER||GMC Ratio|0.84||||0.104|TWO_SIDED|95.0|0.72|0.98||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.98|0.72|0.104
70998358|NCT01392378|141503828|SUPERIORITY_OR_OTHER||GMC Ratio|0.74||||0.001|TWO_SIDED|95.0|0.63|0.87||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.87|0.63|0.001
70998359|NCT01392378|141503828|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.813|TWO_SIDED|95.0|0.82|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.09|0.82|0.813
71041495|NCT00996437|141591805|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Fisher Exact|At each time point, treatment comparison analysis was performed using a Fisher Exact Test.||||||0.27
71041496|NCT04443569|141591806|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||Post-Op Day 1||||0.3
71041497|NCT04443569|141591806|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||Post-Op Day 2||||0.9
71041498|NCT04443569|141591806|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||Post-Op Day 3||||0.07
71100292|NCT01887600|141709234|SUPERIORITY||Least squares mean difference|1.645|||<|0.001|TWO_SIDED|95.0|1.41|1.88||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 40. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.88|1.41|<0.001
70998360|NCT01392378|141503828|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.837|TWO_SIDED|95.0|0.9|1.19||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.19|0.90|0.837
71041499|NCT04443569|141591806|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||Post-Op Day 4||||0.09
71041500|NCT04443569|141591807|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
71041501|NCT01729026|141591870|SUPERIORITY_OR_OTHER_LEGACY||Effect size (Cohen's d)|-0.75||||0.141|TWO_SIDED|95.0|-1.85|0.35||Between baseline and 3-month follow-up, subjects in the Adoption group had a mean improvement of 15.20 points on the PCL-5 compared to 7.77 points in the Wait-list group.|Mixed effects regression models|||The analyses were mixed effect regression models with repeated measures at randomization (baseline) and at the 3-month post-randomization follow-up using a 2 x 2 design. Treatment (Adoption group vs Wait-list group), time (baseline and 3-month follow-up) and their interaction were the fixed design effects. The treatment by time interaction tests the significance of the difference between baseline and 3-month follow-up between the Adoption and Wait-list groups.||0.35|-1.85|0.141
71041502|NCT01729026|141591871|SUPERIORITY||effect size (Cohen's d)|0.0||||0.982|TWO_SIDED||||||effect size (Cohen's d)|||||||0.982
71041503|NCT01729026|141591872|SUPERIORITY||effect size (Cohen's d)|-0.5||||0.16|TWO_SIDED||||||effect size (Cohen's d)|||||||0.160
71041504|NCT01729026|141591873|SUPERIORITY||effect size (Cohen's d)|-1.36||||0.015|TWO_SIDED|95.0|-2.49|-0.23|||effect size (Cohen's d)|||||-0.23|-2.49|0.015
71041505|NCT01729026|141591874|SUPERIORITY||effect size (Cohen's d)|0.2||||0.59|TWO_SIDED||||||Mixed Models Analysis|||||||0.59
71041506|NCT01729026|141591875|SUPERIORITY||mixed effects regression models|-1.41||||0.01|TWO_SIDED|95.0|-2.5|-0.31|||effect size (Cohen's d)|||||-0.31|-2.50|0.010
71041507|NCT01729026|141591876|SUPERIORITY|||||||0.13|||||||Fisher Exact|||||||0.13
71041508|NCT01729026|141591877|SUPERIORITY||effect size (Cohen's d)|0.9||||0.188|TWO_SIDED||||||effect size (Cohen's d)|||||||0.188
71041509|NCT01729026|141591879|SUPERIORITY||effect size (Cohen's d)|1.2||||0.031|TWO_SIDED||||||mixed effects regression models|||||||0.031
70998361|NCT01392378|141503828|SUPERIORITY_OR_OTHER||GMC Ratio|0.93||||0.534|TWO_SIDED|95.0|0.81|1.07||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.07|0.81|0.534
70998362|NCT01392378|141503828|SUPERIORITY_OR_OTHER||GMC Ratio|1.0||||0.961|TWO_SIDED|95.0|0.87|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.87|0.961
70998363|NCT01392378|141503829|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.85|TWO_SIDED|95.0|0.75|1.42||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.42|0.75|0.850
70998364|NCT01392378|141503829|SUPERIORITY_OR_OTHER||GMC Ratio|1.05||||0.837|TWO_SIDED|95.0|0.77|1.44||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.44|0.77|0.837
70998365|NCT01392378|141503829|SUPERIORITY_OR_OTHER||GMC Ratio|0.94||||0.695|TWO_SIDED|95.0|0.69|1.28||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.28|0.69|0.695
70998366|NCT01392378|141503829|SUPERIORITY_OR_OTHER||GMC Ratio|0.82||||0.408|TWO_SIDED|95.0|0.6|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.60|0.408
70998367|NCT01392378|141503830|SUPERIORITY_OR_OTHER||GMT Ratio|0.95||||0.813|TWO_SIDED|95.0|0.69|1.3||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.30|0.69|0.813
70998368|NCT01392378|141503830|SUPERIORITY_OR_OTHER||GMT Ratio|0.92||||0.837|TWO_SIDED|95.0|0.68|1.25||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.25|0.68|0.837
70998369|NCT01392378|141503830|SUPERIORITY_OR_OTHER||GMT Ratio|0.94||||0.695|TWO_SIDED|95.0|0.68|1.28||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.28|0.68|0.695
70998370|NCT01392378|141503830|SUPERIORITY_OR_OTHER||GMT Ratio|0.98||||0.961|TWO_SIDED|95.0|0.71|1.36||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.36|0.71|0.961
70998371|NCT01392378|141503830|SUPERIORITY_OR_OTHER||GMT Ratio|1.18||||0.808|TWO_SIDED|95.0|0.85|1.65||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.65|0.85|0.808
70998372|NCT01392378|141503830|SUPERIORITY_OR_OTHER||GMT Ratio|1.09||||0.837|TWO_SIDED|95.0|0.8|1.5||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.50|0.80|0.837
70998373|NCT01392378|141503830|SUPERIORITY_OR_OTHER||GMT Ratio|0.92||||0.695|TWO_SIDED|95.0|0.66|1.28||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.28|0.66|0.695
70998374|NCT01392378|141503830|SUPERIORITY_OR_OTHER||GMT Ratio|0.82||||0.408|TWO_SIDED|95.0|0.58|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.58|0.408
70998375|NCT01392378|141503830|SUPERIORITY_OR_OTHER||GMT Ratio|1.07||||0.813|TWO_SIDED|95.0|0.78|1.46||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.46|0.78|0.813
70998376|NCT01392378|141503830|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.343|TWO_SIDED|95.0|0.59|1.08||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.08|0.59|0.343
70998377|NCT01392378|141503830|SUPERIORITY_OR_OTHER||GMT Ratio|1.12||||0.695|TWO_SIDED|95.0|0.82|1.52||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.52|0.82|0.695
70998378|NCT01392378|141503830|SUPERIORITY_OR_OTHER||GMT Ratio|0.95||||0.925|TWO_SIDED|95.0|0.69|1.31||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.31|0.69|0.925
70998379|NCT01392378|141503831|SUPERIORITY_OR_OTHER||GMC Ratio|1.08||||0.91|TWO_SIDED|95.0|0.81|1.43||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.43|0.81|0.910
71100293|NCT01887600|141709234|SUPERIORITY||Least squares mean difference|1.699|||<|0.001|TWO_SIDED|95.0|1.45|1.94||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 44. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.94|1.45|<0.001
70923884|NCT01820260|141339731|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0037|TWO_SIDED|||||see comments in analysis 1|Fisher Exact|||See comment in analysis 1||||0.0037
70998380|NCT01392378|141503831|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.85|TWO_SIDED|95.0|0.79|1.37||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.37|0.79|0.850
70998381|NCT01392378|141503831|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.868|TWO_SIDED|95.0|0.7|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.21|0.70|0.868
70998382|NCT01392378|141503831|SUPERIORITY_OR_OTHER||GMC Ratio|0.87||||0.914|TWO_SIDED|95.0|0.67|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.67|0.914
70998383|NCT01392378|141503832|SUPERIORITY_OR_OTHER||GMC Ratio|1.05||||0.91|TWO_SIDED|95.0|0.89|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.89|0.910
70998384|NCT01392378|141503832|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.85|TWO_SIDED|95.0|0.89|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.89|0.850
70998385|NCT01392378|141503832|SUPERIORITY_OR_OTHER||GMC Ratio|1.0||||0.961|TWO_SIDED|95.0|0.85|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.16|0.85|0.961
70998386|NCT01392378|141503832|SUPERIORITY_OR_OTHER||GMC Ratio|0.99||||0.916|TWO_SIDED|95.0|0.85|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.16|0.85|0.916
70998387|NCT01392378|141503832|SUPERIORITY_OR_OTHER||GMC Ratio|0.99||||0.91|TWO_SIDED|95.0|0.87|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.87|0.910
70923885|NCT01820260|141339731|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0171|TWO_SIDED|||||See comments in analysis 1|Fisher Exact|||See comments in analysis 1||||0.0171
70923886|NCT01820260|141339731|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|TWO_SIDED||||||Fisher Exact|||||||0.0001
70998388|NCT01392378|141503832|SUPERIORITY_OR_OTHER||GMC Ratio|1.01||||0.909|TWO_SIDED|95.0|0.89|1.14||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.14|0.89|0.909
70998389|NCT01392378|141503832|SUPERIORITY_OR_OTHER||GMC Ratio|1.06||||0.868|TWO_SIDED|95.0|0.93|1.2||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.20|0.93|0.868
70998390|NCT01392378|141503832|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.914|TWO_SIDED|95.0|0.81|1.05||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.05|0.81|0.914
70998391|NCT01392378|141503832|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.91|TWO_SIDED|95.0|0.76|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.76|0.910
70998392|NCT01392378|141503832|SUPERIORITY_OR_OTHER||GMC Ratio|0.91||||0.85|TWO_SIDED|95.0|0.76|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.09|0.76|0.850
70998393|NCT01392378|141503832|SUPERIORITY_OR_OTHER||GMC Ratio|0.93||||0.868|TWO_SIDED|95.0|0.78|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.78|0.868
70998394|NCT01392378|141503832|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.914|TWO_SIDED|95.0|0.76|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.76|0.914
71041510|NCT01729026|141591880|SUPERIORITY||effect size (Cohen's d)|0.3||||0.541|TWO_SIDED|95.0|-0.8|1.4|||effect size (Cohen's d)|||||1.40|-0.80|0.541
70998395|NCT01392378|141503833|SUPERIORITY_OR_OTHER||GMC Ratio|0.96||||0.91|TWO_SIDED|95.0|0.83|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.83|0.910
70998396|NCT01392378|141503833|SUPERIORITY_OR_OTHER||GMC Ratio|0.94||||0.85|TWO_SIDED|95.0|0.82|1.07||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.07|0.82|0.850
70998397|NCT01392378|141503833|SUPERIORITY_OR_OTHER||GMC Ratio|0.98||||0.939|TWO_SIDED|95.0|0.86|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.86|0.939
70998398|NCT01392378|141503833|SUPERIORITY_OR_OTHER||GMC Ratio|0.86||||0.279|TWO_SIDED|95.0|0.75|0.98||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.98|0.75|0.279
70998399|NCT01392378|141503833|SUPERIORITY_OR_OTHER||GMC Ratio|0.86||||0.149|TWO_SIDED|95.0|0.76|0.97||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.97|0.76|0.149
70998400|NCT01392378|141503833|SUPERIORITY_OR_OTHER||GMC Ratio|1.02||||0.85|TWO_SIDED|95.0|0.91|1.14||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.14|0.91|0.850
70998401|NCT01392378|141503833|SUPERIORITY_OR_OTHER||GMC Ratio|0.89||||0.394|TWO_SIDED|95.0|0.79|0.99||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.99|0.79|0.394
71041511|NCT01729026|141591881|SUPERIORITY||effect size (Cohen's d)|0.6||||0.139|TWO_SIDED||||||effect size (Cohen's d)|||Please note that a minus number indicates an increase in pain ratings.||||0.139
70998402|NCT01392378|141503833|SUPERIORITY_OR_OTHER||GMC Ratio|0.98||||0.916|TWO_SIDED|95.0|0.87|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.87|0.916
70998403|NCT01392378|141503834|SUPERIORITY_OR_OTHER||GMC Ratio|1.26||||0.869|TWO_SIDED|95.0|0.9|1.76||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.76|0.90|0.869
70998404|NCT01392378|141503834|SUPERIORITY_OR_OTHER||GMC Ratio|1.07||||0.85|TWO_SIDED|95.0|0.78|1.48||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.48|0.78|0.850
71041512|NCT00979212|141591913|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96||||||One-sided test at significance level of 0.05|Fisher Exact|||Null hypothesis (H0) was that the experimental treatment was not effective vs the alternative hypothesis (HA) that it was. H0: OR ≤ 1 vs. HA: OR \> 1, where odds ratio (OR)= \[p2\*(1- p1)\]/ \[p1\*(1- p2)\], p1 denotes the mediastinal clearance rate (MCR) on Induction chemoradiation; p2 denotes the MCR on Induction chemoradiation + panitumumab. Fisher's exact test was used to compare the MCRs; the 95% confidence interval was calculated using Clopper-Pearson method. 97 patients were required.||||0.96
71041513|NCT00309985|141591922|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|TWO_SIDED||||||Log Rank|||The study was designed to detect a 33.3% improvement in median survival time across treatments with one-sided type I error of 0.025 and 80% power.||||0.0003
70998405|NCT01392378|141503834|SUPERIORITY_OR_OTHER||GMC Ratio|1.1||||0.868|TWO_SIDED|95.0|0.8|1.52||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.52|0.80|0.868
70998406|NCT01392378|141503834|SUPERIORITY_OR_OTHER||GMC Ratio|1.1||||0.916|TWO_SIDED|95.0|0.8|1.52||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.52|0.80|0.916
70998407|NCT01392378|141503835|SUPERIORITY_OR_OTHER||GMT Ratio|0.98||||0.91|TWO_SIDED|95.0|0.78|1.24||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.24|0.78|0.910
70998408|NCT01392378|141503835|SUPERIORITY_OR_OTHER||GMT Ratio|1.05||||0.85|TWO_SIDED|95.0|0.83|1.32||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.32|0.83|0.850
70998409|NCT01392378|141503835|SUPERIORITY_OR_OTHER||GMT Ratio|1.09||||0.868|TWO_SIDED|95.0|0.87|1.37||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.37|0.87|0.868
70998410|NCT01392378|141503835|SUPERIORITY_OR_OTHER||GMT Ratio|1.02||||0.916|TWO_SIDED|95.0|0.81|1.28||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.28|0.81|0.916
71041514|NCT00309985|141591923|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
71041515|NCT00309985|141591924|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
71041516|NCT00309985|141591925|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
71041517|NCT00309985|141591926|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
71041518|NCT00309985|141591927|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0009
71100294|NCT01887600|141709234|SUPERIORITY||Least squares mean difference|1.446|||<|0.001|TWO_SIDED|95.0|1.2|1.69||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change From BL to week 48. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.69|1.20|<0.001
70998411|NCT01392378|141503835|SUPERIORITY_OR_OTHER||GMT Ratio|0.99||||0.91|TWO_SIDED|95.0|0.79|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.79|0.910
71041519|NCT00309985|141591927|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.40
70998412|NCT01392378|141503835|SUPERIORITY_OR_OTHER||GMT Ratio|0.94||||0.85|TWO_SIDED|95.0|0.76|1.17||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.17|0.76|0.850
70998413|NCT01392378|141503835|SUPERIORITY_OR_OTHER||GMT Ratio|0.95||||0.868|TWO_SIDED|95.0|0.77|1.17||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.17|0.77|0.868
71041520|NCT01294449|141591961|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.37|TWO_SIDED|95.0|0.67|1.161|||Regression, Cox||The hazard ratio was calculated as the hazard rate of mortality in the CRT-D group over the hazard rate of mortality in the ICD group. A hazard ratio lower than 1 represents a reduction in relative risk of mortality for CRT-D compared to ICD.|The sample size for the analysis included subjects from the original MADIT-CRT IDE (NCT00180271) that did not participate in the Registry portion, these subjects are censored at the time of study conclusion, withdrawal or death during the IDE. This was done as the Registry is a post approval continuation of the follow-up from the MADIT-CRT IDE trial. This is not a pooled analysis from separate studies.||1.161|0.670|0.370
71041521|NCT01294449|141591961|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.028|TWO_SIDED|95.0|0.484|0.96|||Regression, Cox||The hazard ratio was calculated as the hazard rate of mortality in the CRT-D arm over the hazard rate of mortality in the ICD arm. A hazard ratio lower than 1 represents a reduction in relative risk of mortality for CRT-D compared to ICD.|These data represent the indicated sub population of left bundle branch block subjects only. (Left bundle branch block N= 110 ICD group: 181 CRT-D group)||0.960|0.484|0.028
71100295|NCT01887600|141709234|SUPERIORITY||Least squares mean difference|1.641|||<|0.001|TWO_SIDED|95.0|1.39|1.89||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 52. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit.The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.89|1.39|<0.001
71100296|NCT01887600|141709234|SUPERIORITY||Least squares mean difference|1.64|||<|0.001|TWO_SIDED|95.0|1.37|1.91||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 56. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit.The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.91|1.37|<0.001
70998414|NCT01392378|141503835|SUPERIORITY_OR_OTHER||GMT Ratio|0.98||||0.916|TWO_SIDED|95.0|0.79|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.21|0.79|0.916
70998415|NCT01392378|141503835|SUPERIORITY_OR_OTHER||GMT Ratio|0.97||||0.91|TWO_SIDED|95.0|0.77|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.77|0.910
70998416|NCT01392378|141503835|SUPERIORITY_OR_OTHER||GMT Ratio|0.84||||0.85|TWO_SIDED|95.0|0.67|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.67|0.850
70998417|NCT01392378|141503835|SUPERIORITY_OR_OTHER||GMT Ratio|0.98||||0.939|TWO_SIDED|95.0|0.78|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.78|0.939
70998418|NCT01392378|141503835|SUPERIORITY_OR_OTHER||GMT Ratio|0.96||||0.916|TWO_SIDED|95.0|0.76|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.21|0.76|0.916
70998419|NCT04491240|141503865|SUPERIORITY||Mean Difference (Net)|73.29|STANDARD_DEVIATION|82.91404||0.020875|TWO_SIDED|95.0|13.97687|132.6031|||t-test, 2 sided|||The study results were statistically processed using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of inhalation and after were compared using the T-test for depended group criterion, data between the main group and the control group were compared using the non-parametric method, box-plot. The data in the table presented as a Mean with full range (min-max). The difference calculated as Mean difference with 95% confidence interval and Standard Deviation (SD)||132.6031|13.97687|0.020875
70998420|NCT04491240|141503865|SUPERIORITY||Mean Difference (Net)|69.56|STANDARD_DEVIATION|45.67648||0.000953|TWO_SIDED|95.0|36.88502|102.235|||t-test, 2 sided|||The study results were statistically processed using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of inhalation and after were compared using the T-test for depended group criterion, data between the main group and the control group were compared using the non-parametric method, box-plot. The data in the table presented as a Mean with full range (min-max). The difference calculated as Mean difference with 95% confidence interval and Standard Deviation (SD)||102.2350|36.88502|0.000953
70998421|NCT04491240|141503865|SUPERIORITY||Mean Difference (Net)|53.21|STANDARD_DEVIATION|39.85531||0.002233|TWO_SIDED|95.0|24.69923|81.72077|||t-test, 2 sided|||The study results were statistically processed using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of inhalation and after were compared using the T-test for depended group criterion, data between the main group and the control group were compared using the non-parametric method, box-plot. The data in the table presented as a Mean with full range (min-max). The difference calculated as Mean difference with 95% confidence interval and Standard Deviation (SD)||81.72077|24.69923|0.002233
70998422|NCT04491240|141503866|SUPERIORITY||Mean Difference (Net)|331.52|STANDARD_DEVIATION|315.823||0.008948|TWO_SIDED|95.0|105.5938|557.4462|||t-test, 2 sided|||The study results were statistically processed using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of inhalation and after were compared using the T-test for depended group criterion, data between the main group and the control group were compared using the non-parametric method, box-plot. The data in the table presented as a Mean with full range (min-max). The difference calculated as Mean difference with 95% confidence interval and Standard Deviation (SD)||557.4462|105.5938|0.008948
70998423|NCT04491240|141503866|SUPERIORITY||Mean Difference (Net)|366.63|STANDARD_DEVIATION|414.9726||0.020921|TWO_SIDED|95.0|69.77651|663.4835|||t-test, 2 sided|||The study results were statistically processed using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of inhalation and after were compared using the T-test for depended group criterion, data between the main group and the control group were compared using the non-parametric method, box-plot. The data in the table presented as a Mean with full range (min-max). The difference calculated as Mean difference with 95% confidence interval and Standard Deviation (SD)||663.4835|69.77651|0.020921
70998424|NCT04491240|141503866|SUPERIORITY||Mean Difference (Net)|239.2|STANDARD_DEVIATION|204.0934||0.004873|TWO_SIDED|95.0|93.20037|385.1996|||t-test, 2 sided|||The study results were statistically processed using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of inhalation and after were compared using the T-test for depended group criterion, data between the main group and the control group were compared using the non-parametric method, box-plot. The data in the table presented as a Mean with full range (min-max). The difference calculated as Mean difference with 95% confidence interval and Standard Deviation (SD)||385.1996|93.20037|0.004873
71100297|NCT01887600|141709234|SUPERIORITY||Least squares mean difference|1.634|||<|0.001|TWO_SIDED|95.0|1.33|1.94||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 60. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.94|1.33|<0.001
70998425|NCT03549117|141503867|SUPERIORITY||Least square (LS) mean difference|0.15||||0.8142|TWO_SIDED|95.0|-1.14|1.45||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep problems.||1.45|-1.14|0.8142
71041522|NCT03222037|141591962|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the 97.5% confidence interval was below 0.05.|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|97.5|-0.09|-0.02|||Linear Mixed Model|Linear mixed model with Kenward and Roger method for degrees of freedom|Mean difference was calculated as Test- SCR. This comparison is for high lumniance low contrast|Comparison between the Test and the SCR treatments was carried out using 97.5% confidence intervals for the least-square mean differences.||-0.02|-0.09|
71041523|NCT03222037|141591962|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the 97.5% confidence interval was below 0.05|Median Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|97.5|-0.06|-0.01|||Linear Mixed Model|Linear mixed model with Kenward and Roger method for denominator degrees of freedom|Mean difference was calculated as Test- SCR. This comparison is for Low luminance high contrast|||-0.01|-0.06|
71041524|NCT03222037|141591963|EQUIVALENCE|Statistical significance is declared if the lower limit of the 95% confidence interval is above 0 or if the upper limit of the 95% confidence interval is below 0.|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.02||0.0066|TWO_SIDED|95.0|0.01|0.08|||Linear Mixed Model|Linear Mixed Model with Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - SCR.|Comparison between the Test and SCR treatments was carried out using least-square mean differences||0.08|0.01|0.0066
71041525|NCT00496262|141591964|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.9|STANDARD_DEVIATION|4.4|<|0.0001||90.0|||||2-sided, 1-sample t-test||The entire ITT population was used for a conservative analysis of the mean change in MCF. The mean change was set to 0 for any subject with missing MCF data.|This is an open-label study with statistical comparison between MCF pre-infusion and 1 hour post-infusion.||||<0.0001
71041526|NCT04291508|141591982|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.65|TWO_SIDED|95.0|-1.6|2.5|||t-test, 2 sided|||||2.5|-1.6|0.65
71041527|NCT04291508|141591982|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.464|TWO_SIDED|95.0|-3.5|7.6|||t-test, 2 sided|||||7.6|-3.5|0.464
71041528|NCT04291508|141591983|SUPERIORITY||Risk Difference (RD)|-4.3||||0.26|TWO_SIDED|95.0|-12.0|3.3|||Chi-squared|||||3.3|-12.0|0.26
71041529|NCT04291508|141591983|SUPERIORITY||Risk Difference (RD)|-13.6||||0.31|TWO_SIDED|95.0|-35.8|8.7|||Fisher Exact|||||8.7|-35.8|0.31
71041530|NCT04291508|141591984|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.35|TWO_SIDED|95.0|-1.0|2.9|||t-test, 2 sided|||||2.9|-1.0|0.35
71041531|NCT04291508|141591984|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.45|TWO_SIDED|95.0|-3.4|7.6|||t-test, 2 sided|||||7.6|-3.4|0.45
71041532|NCT04291508|141591985|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.83|TWO_SIDED|95.0|-1.9|1.5|||t-test, 2 sided|||||1.5|-1.9|0.83
71041533|NCT04291508|141591985|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.1|TWO_SIDED|95.0|-0.8|8.9|||t-test, 2 sided|||||8.9|-0.8|0.10
71041534|NCT04291508|141591986|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.55|TWO_SIDED|95.0|-1.2|2.4|||t-test, 2 sided|||||2.4|-1.2|0.55
71041535|NCT04291508|141591986|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.18|TWO_SIDED|95.0|-1.6|8.7|||t-test, 2 sided|||||8.7|-1.6|0.18
71041536|NCT04291508|141591987|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.21|TWO_SIDED|95.0|-0.8|3.6|||t-test, 2 sided|||||3.6|-0.8|0.21
70998426|NCT03549117|141503867|SUPERIORITY||LS mean difference|-0.7||||0.369|TWO_SIDED|95.0|-2.23|0.84||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep Time Problems.||0.84|-2.23|0.3690
70998427|NCT03549117|141503867|SUPERIORITY||LS mean difference|-0.18||||0.7995|TWO_SIDED|95.0|-1.61|1.25||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline; between treatment 95% CI.|Treatment comparison of NRQLQ between active and placebo strip group for Symptoms on Waking in the Morning.||1.25|-1.61|0.7995
70998428|NCT03549117|141503867|SUPERIORITY||LS mean difference|0.15||||0.7285|TWO_SIDED|95.0|-0.69|0.98||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Practical Problems.||0.98|-0.69|0.7285
71041537|NCT04291508|141591987|SUPERIORITY||Mean Difference (Final Values)|2.5||||0.4|TWO_SIDED|95.0|-3.4|8.5|||t-test, 2 sided|||||8.5|-3.4|0.40
71041538|NCT04291508|141591988|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.23|TWO_SIDED|95.0|-0.8|3.4|||t-test, 2 sided|||||3.4|-0.8|0.23
71041539|NCT04291508|141591988|SUPERIORITY||Mean Difference (Final Values)|3.6||||0.22|TWO_SIDED|95.0|-2.2|9.4|||t-test, 2 sided|||||9.4|-2.2|0.22
71041540|NCT04291508|141591989|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.58|TWO_SIDED|95.0|-1.6|2.8|||t-test, 2 sided|||||2.8|-1.6|0.58
71041541|NCT04291508|141591989|SUPERIORITY||Mean Difference (Final Values)|4.5||||0.13|TWO_SIDED|95.0|-1.4|10.5|||t-test, 2 sided|||||10.5|-1.4|0.13
71041542|NCT04291508|141591990|SUPERIORITY||Risk Difference (RD)|-4.3||||0.26|TWO_SIDED|95.0|-11.8|3.2|||Chi-squared|||||3.2|-11.8|0.26
71041543|NCT04291508|141591990|SUPERIORITY||Risk Difference (RD)|-13.6||||0.31|TWO_SIDED|95.0|-35.8|8.7|||Fisher Exact|||||8.7|-35.8|0.31
71041544|NCT04291508|141591991|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.76|TWO_SIDED|95.0|-1.6|2.2|||t-test, 2 sided|||||2.2|-1.6|0.76
71041545|NCT04291508|141591991|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.78|TWO_SIDED|95.0|-4.9|6.5|||t-test, 2 sided|||||6.5|-4.9|0.78
71041546|NCT04291508|141591992|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.84|TWO_SIDED|95.0|-2.3|1.9|||t-test, 2 sided|||||1.9|-2.3|0.84
71041547|NCT04291508|141591992|SUPERIORITY||Mean Difference (Final Values)|4.5||||0.1|TWO_SIDED|95.0|-0.9|10.0|||t-test, 2 sided|||||10.0|-0.9|0.10
71041548|NCT04291508|141591993|SUPERIORITY||Risk Difference (RD)|-1.3||||0.79|TWO_SIDED|95.0|-10.9|8.3|||Chi-squared|||||8.3|-10.9|0.79
71041549|NCT04291508|141591993|SUPERIORITY||Risk Difference (RD)|4.9||||1|TWO_SIDED|95.0|-17.5|27.3|||Fisher Exact|||||27.3|-17.5|1.00
70998429|NCT03549117|141503868|SUPERIORITY||LS mean difference|-0.18||||0.7961|TWO_SIDED|95.0|-1.52|1.17||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep problems.||1.17|-1.52|0.7961
70998430|NCT03549117|141503868|SUPERIORITY||LS mean difference|-0.86||||0.271|TWO_SIDED|95.0|-2.41|0.68||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep time problems.||0.68|-2.41|0.2710
70998431|NCT03549117|141503868|SUPERIORITY||LS mean difference|-0.07||||0.9236|TWO_SIDED|95.0|-1.6|1.45||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for symptoms on waking in the morning.||1.45|-1.60|0.9236
70998432|NCT03549117|141503868|SUPERIORITY||LS mean difference|-0.05||||0.8756|TWO_SIDED|95.0|-0.87|0.75||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for practical problems.||0.75|-0.87|0.8756
70998433|NCT03549117|141503869|SUPERIORITY||LS mean difference|0.02||||0.9314|TWO_SIDED|95.0|-0.38|0.42||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for feel tired and unrefreshed.||0.42|-0.38|0.9314
70998434|NCT03549117|141503869|SUPERIORITY||LS mean difference|-0.05||||0.8005|TWO_SIDED|95.0|-0.45|0.35||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for nasal congestion or stuffy nose.||0.35|-0.45|0.8005
70998435|NCT03549117|141503869|SUPERIORITY||LS mean difference|0.01||||0.9613|TWO_SIDED|95.0|-0.38|0.4||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for congestion in sinuses.||0.40|-0.38|0.9613
70998436|NCT03549117|141503869|SUPERIORITY||LS mean difference|-0.14||||0.4966|TWO_SIDED|95.0|-0.54|0.26||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for time to clear nighttime drainage after waking up.||0.26|-0.54|0.4966
70998437|NCT03549117|141503870|SUPERIORITY||LS mean difference|0.03||||0.8775|TWO_SIDED|95.0|-0.39|0.45||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for feel tired and unrefreshed.||0.45|-0.39|0.8775
70998438|NCT03549117|141503870|SUPERIORITY||LS mean difference|-0.06||||0.7747|TWO_SIDED|95.0|-0.47|0.35||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for nasal congestion or stuffy nose.||0.35|-0.47|0.7747
71041550|NCT04291508|141591994|SUPERIORITY||Risk Difference (RD)|1.7||||0.53|TWO_SIDED|95.0|-3.7|7.2|||Chi-squared|||||7.2|-3.7|0.53
71041551|NCT04291508|141591994|SUPERIORITY||Risk Difference (RD)|-2.0||||1|TWO_SIDED|95.0|-17.0|13.0|||Fisher Exact|||||13.0|-17.0|1.00
71041552|NCT04291508|141591995|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.7|TWO_SIDED|95.0|-0.9|0.6|||t-test, 2 sided|||||0.6|-0.9|0.70
70998439|NCT03549117|141503870|SUPERIORITY||LS mean difference|0.04||||0.8535|TWO_SIDED|95.0|-0.39|0.47||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for congestion in sinuses.||0.47|-0.39|0.8535
70998440|NCT03549117|141503870|SUPERIORITY||LS mean difference|-0.06||||0.772|TWO_SIDED|95.0|-0.47|0.35||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for time to clear nighttime drainage after waking up.||0.35|-0.47|0.7720
70998441|NCT03549117|141503871|SUPERIORITY|||||||0.9258|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep problems.||||0.9258
70998442|NCT03549117|141503871|SUPERIORITY|||||||0.2368|||||||Chi-squared|P-value are based on chi-square test.||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep problems.||||0.2368
70998443|NCT03549117|141503871|SUPERIORITY|||||||0.4432|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep time problems.||||0.4432
70998444|NCT03549117|141503871|SUPERIORITY|||||||0.9856|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep time problems.||||0.9856
71041553|NCT04291508|141591995|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.96|TWO_SIDED|95.0|-2.7|2.5|||t-test, 2 sided|||||2.5|-2.7|0.96
71041554|NCT04291508|141591996|SUPERIORITY||Risk Difference (RD)|2.5||||1|TWO_SIDED|95.0|-2.3|7.3|||Fisher Exact|||||7.3|-2.3|1.00
70998445|NCT03549117|141503871|SUPERIORITY|||||||0.7854|||||||Chi-squared|P-value are based on chi-square test.||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in symptoms on waking in AM.||||0.7854
70998446|NCT03549117|141503871|SUPERIORITY|||||||0.4141|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in symptoms on waking in AM.||||0.4141
70998447|NCT03549117|141503871|SUPERIORITY|||||||0.3028|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in practical problems.||||0.3028
71041555|NCT04291508|141591997|SUPERIORITY||Risk Difference (RD)|-4.4||||0.31|TWO_SIDED|95.0|-13.1|4.2|||Chi-squared|||||4.2|-13.1|0.31
71041556|NCT04291508|141591997|SUPERIORITY||Risk Difference (RD)|-27.9||||0.02|TWO_SIDED|95.0|-51.7|-4.0|||Chi-squared|||||-4.0|-51.7|0.02
71041557|NCT04291508|141591998|SUPERIORITY||Risk Difference (RD)|-0.5||||0.9|TWO_SIDED|95.0|-8.5|7.5|||Chi-squared|||||7.5|-8.5|0.90
71041558|NCT04291508|141591998|SUPERIORITY||Risk Difference (RD)|-27.9||||0.02|TWO_SIDED|95.0|-51.7|-4.0|||Chi-squared|||||-4.0|-51.7|0.02
71041559|NCT04291508|141591999|SUPERIORITY||Risk Difference (RD)|-7.3||||0.003|TWO_SIDED|95.0|-12.2|-2.4|||Chi-squared|||||-2.4|-12.2|0.003
71041560|NCT04291508|141591999|SUPERIORITY||Risk Difference (RD)|6.7||||0.52|TWO_SIDED|95.0|-2.3|15.6|||Fisher Exact|||||15.6|-2.3|0.52
71100298|NCT01887600|141709234|SUPERIORITY||Least squares mean difference|1.404|||<|0.001|TWO_SIDED|95.0|1.08|1.73||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 64. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.73|1.08|<0.001
71100299|NCT01887600|141709234|SUPERIORITY||Least squares mean difference|1.499|||<|0.001|TWO_SIDED|95.0|1.18|1.82||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change From BL to week 68. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.82|1.18|<0.001
71100300|NCT01887600|141709234|SUPERIORITY||Least squares mean difference|1.438|||<|0.001|TWO_SIDED|95.0|1.1|1.78||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 72. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.78|1.10|<0.001
70998448|NCT03549117|141503871|SUPERIORITY|||||||0.3955|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in practical problems.||||0.3955
70998449|NCT03549117|141503872|SUPERIORITY|||||||0.3826|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep problems.||||0.3826
71041561|NCT04291508|141592000|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.68|TWO_SIDED|95.0|-0.2|0.2|||t-test, 2 sided|||||0.2|-0.2|0.68
71041562|NCT04291508|141592000|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.62|TWO_SIDED|95.0|-0.7|0.4|||Fisher Exact|||||0.4|-0.7|0.62
70998450|NCT03549117|141503872|SUPERIORITY|||||||0.6251|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep problems.||||0.6251
71041563|NCT04291508|141592001|SUPERIORITY||Risk Difference (RD)|0.5||||0.9|TWO_SIDED|95.0|-7.8|8.8|||Chi-squared|||||8.8|-7.8|0.90
71041564|NCT04291508|141592001|SUPERIORITY||Risk Difference (RD)|-15.6||||0.2|TWO_SIDED|95.0|-40.1|8.9|||Chi-squared|||||8.9|-40.1|0.2
71041565|NCT04291508|141592002|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.88|TWO_SIDED|95.0|-1.1|1.3|||t-test, 2 sided|||||1.3|-1.1|0.88
71041566|NCT04291508|141592002|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.1|TWO_SIDED|95.0|-0.6|6.6|||t-test, 2 sided|||||6.6|-0.6|0.10
71041567|NCT02625974|141592009|OTHER|A direct comparison|Difference in cure rate|14.0|||||TWO_SIDED|95.0|3.7|24.2||||||||24.2|3.7|
71041568|NCT02625974|141592010|OTHER|Incidence rate and 95% CI of seronegative conversion|Risk Ratio (RR)|2.12|||||TWO_SIDED|95.0|1.21|3.45|||||Person-year = 754|||3.45|1.21|
71100301|NCT01887600|141709234|SUPERIORITY||Least squares mean difference|1.185|||<|0.001|TWO_SIDED|95.0|0.83|1.54||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 76. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.54|0.83|<0.001
71100302|NCT01887600|141709234|SUPERIORITY||Least squares mean difference|1.443|||<|0.001|TWO_SIDED|95.0|1.11|1.78||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 80. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.78|1.11|<0.001
70998451|NCT03549117|141503872|SUPERIORITY|||||||0.2381|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep time problems.||||0.2381
70998452|NCT03549117|141503872|SUPERIORITY|||||||0.4245|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep time problems.||||0.4245
70998453|NCT03549117|141503872|SUPERIORITY|||||||0.8213|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in symptoms on waking in AM.||||0.8213
70998454|NCT03549117|141503872|SUPERIORITY|||||||0.1823|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in symptoms on waking in AM.||||0.1823
70998455|NCT03549117|141503872|SUPERIORITY|||||||0.7744|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in practical problems.||||0.7744
70998456|NCT03549117|141503872|SUPERIORITY|||||||0.5811|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in practical problems.||||0.5811
70998457|NCT00014911|141503889|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|44.0|||||TWO_SIDED|95.0|30.0|61.0|||Fisher Exact|||||61|30|
70998458|NCT00014911|141503890|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|28.0|||||TWO_SIDED|95.0|16.0|44.0|||Fisher Exact|||||44|16|
70998459|NCT00014911|141503891|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|58.0|||||TWO_SIDED|95.0|42.0|63.0|||Fisher Exact|||||63|42|
70998460|NCT00605072|141503901|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||p-value for between group comparison (group\*visit)|Mixed Models Analysis|Adjusted for baseline AGE and Mini-Mental-State-Examination||||||0.008
70998461|NCT00605072|141503902|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||Mixed Models Analysis|adjusted for age||||||0.74
70998462|NCT00605072|141503903|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||Mixed Models Analysis|Adjusted for age at baseline||||||0.81
70998463|NCT00605072|141503904|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Mixed Models Analysis|||||||0.87
70998464|NCT00605072|141503905|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Mixed Models Analysis|||||||0.79
70998465|NCT05064332|141503906|OTHER||Ratio of Adjusted Geometric Means|101.43|||||TWO_SIDED|90.0|93.01|110.61||||||OC alone as the Reference and co-administration of PF-06650833 and OC as the Test. Natural log transformed AUClast was analyzed using a mixed effects model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||110.61|93.01|
70998466|NCT05064332|141503907|OTHER||Ratio of Adjusted Geometric Means|108.51|||||TWO_SIDED|90.0|98.85|119.11||||||OC alone as the Reference and co-administration of PF-06650833 and OC as the Test. Natural log transformed AUClast was analyzed using a mixed effects model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||119.11|98.85|
70998467|NCT05064332|141503908|OTHER||Ratio of Adjusted Geometric Means|95.07|||||TWO_SIDED|90.0|84.44|107.04||||||OC alone as the Reference and co-administration of PF-06650833 and OC as the Test. Natural log transformed Cmax was analyzed using a mixed effects model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||107.04|84.44|
70998468|NCT05064332|141503909|OTHER||Ratio of Adjusted Geometric Means|117.99|||||TWO_SIDED|90.0|101.82|136.73||||||OC alone as the Reference and co-administration of PF-06650833 and OC as the Test. Natural log transformed Cmax was analyzed using a mixed effects model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||136.73|101.82|
70998469|NCT00523614|141503921|NON_INFERIORITY_OR_EQUIVALENCE|"Size of the study adapted to the use of DNG/EE in female fertile age. Market share of DNG/EE of 13% in Germany. Assuming that 30% of women in the fertile age range were current users of OCs, a prevalence of current use of DNG/EE of about 4% was estimated.~Based on these data the number of cases needed to exclude a twofold increased VTE risk was estimated at about 500-700 cases (based on four controls per case)."|Odds Ratio (OR)|0.89|||<|0.05||95.0|0.57|1.39|||Regression, Logistic|||Null hypothesis: OR ≥ 2 (VTE of DNG/EE vs. other low-dose COC)||1.39|0.57|<0.05
70998470|NCT01379924|141503927|SUPERIORITY||Odds Ratio (OR)|0.25||||0.037|TWO_SIDED|95.0|0.07|0.92|||Regression, Logistic|Adjusted for group differences at baseline and variables associated with differential study retention.|Usual care arm is reference group|Multiple logistic regression modeling used to compute adjusted odds ratios for 12-month follow-up data.||.92|.07|.037
70998471|NCT01379924|141503928|SUPERIORITY||Odds Ratio (OR)|0.24||||0.029|TWO_SIDED|95.0|0.07|0.86|||Regression, Logistic|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.|Usual care arm is reference group.|||.86|.07|.029
70998472|NCT01379924|141503929|SUPERIORITY||Odds Ratio (OR)|0.2||||0.017|TWO_SIDED|95.0|0.06|0.75|||Regression, Logistic|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.|Usual care arm is the reference group|||.75|.06|.017
70998473|NCT01379924|141503930|SUPERIORITY||Group by time interaction term coefficie|4.75|STANDARD_ERROR_OF_MEAN|3.84||0.217|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.217
70998474|NCT01379924|141503931|SUPERIORITY||Group by time interaction term coefficie|2.89|STANDARD_ERROR_OF_MEAN|3.77||0.444|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.444
70998475|NCT01379924|141503932|SUPERIORITY||Group by time interaction term coefficie|9.76|STANDARD_ERROR_OF_MEAN|3.82||0.011|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.011
70998476|NCT01379924|141503934|SUPERIORITY||Group by time interaction term coefficie|0.64|STANDARD_ERROR_OF_MEAN|0.59||0.758|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.758
70998477|NCT01379924|141503935|SUPERIORITY||Group by time interaction term coefficie|1.36|STANDARD_ERROR_OF_MEAN|0.6||0.024|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.024
70998478|NCT01379924|141503936|SUPERIORITY||Group by time interaction term coefficie|2.67|STANDARD_ERROR_OF_MEAN|2.88||0.354|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up||||||.354
70998479|NCT01379924|141503937|SUPERIORITY||Group by time interaction term coefficie|4.43|STANDARD_ERROR_OF_MEAN|2.85||0.121|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.121
70998480|NCT01379924|141503938|SUPERIORITY||Group by time interaction term coefficie|3.67|STANDARD_ERROR_OF_MEAN|2.89||0.205|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.205
70998481|NCT01379924|141503939|SUPERIORITY||Group by time interaction term coefficie|0.65|STANDARD_ERROR_OF_MEAN|2.6||0.803|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.803
70998482|NCT01379924|141503940|SUPERIORITY||Group by time interaction term coefficie|2.41|STANDARD_ERROR_OF_MEAN|2.56||0.347|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.347
70998483|NCT01379924|141503941|SUPERIORITY||Group by time interaction term coefficie|-1.39|STANDARD_ERROR_OF_MEAN|2.59||0.591|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.591
70998484|NCT00713284|141503977|OTHER||||||<|0.05|||||||t-test, 1 sided|||||||<0.05
71041569|NCT02625974|141592015|OTHER|Incidence rate and 95% CI of seronegative conversion|Risk Ratio (RR)|2.11|||||TWO_SIDED|95.0|0.91|4.16|||||Person-year = 379|||4.16|0.91|
71041570|NCT03460990|141592071|SUPERIORITY||Least Squares (LS) Mean Difference|10.0|||<|0.0001|TWO_SIDED|95.0|7.4|12.5|||Mixed-effects model for repeated measure|||||12.5|7.4|< 0.0001
71041571|NCT03460990|141592072|SUPERIORITY||LS Mean Difference|-48.7|||<|0.0001|TWO_SIDED|95.0|-53.9|-43.5|||Mixed-effects model for repeated measure|||||-43.5|-53.9|<0.0001
70998485|NCT03127852|141503978|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||Poststudy between-group comparison of SF-36 physical component summary score.||||.48
71041572|NCT03460990|141592073|SUPERIORITY||LS Mean Difference|13.5|||<|0.0001|TWO_SIDED|95.0|8.8|18.3|||Mixed-effects model for repeated measure|||||18.3|8.8|<0.0001
71041573|NCT01923311|141592076|EQUIVALENCE|A total of 12 test study participants compared to 334 HIV-infected reference study participants will provide at least 90% power to conclude exposure equivalence of EVG AUCtau in test study vs reference study, assuming the expected geometric mean ratio is 1, equivalency boundary is 70% to 143%, 2 one-sided tests are each performed at an alpha level of 0.05, and the standard deviation of EVG AUCtau is 0.36 ng•h/mL (natural log scale, estimated from EVG population PK modeling).|GLSM Ratio (%) (Test/Reference)|135.73|||||TWO_SIDED|90.0|116.24|158.49||||||To determine whether the proposed EVG dose in children achieved similar systemic exposure to adults, statistical comparisons were performed with PK data from the current study (test) and adult data from population PK modeling in study GS-US-183-0145 (NCT00708162) (reference).||158.49|116.24|
71041574|NCT01923311|141592077|EQUIVALENCE|A total of 12 test study participants compared to 334 HIV-infected reference study participants will provide at least 90% power to conclude exposure equivalence of EVG Cmax in test study vs reference study, assuming the expected geometric mean ratio is 1, equivalency boundary is 70% to 143%, 2 one-sided tests are each performed at an alpha level of 0.05, and the standard deviation of EVG Cmax is 0.28 ng•h/mL (natural log scale, estimated from EVG population PK modeling).|GLSM Ratio (%) (Test/Reference)|146.68|||||TWO_SIDED|90.0|127.35|168.94||||||To determine whether the proposed EVG dose in children achieves similar systemic exposure to adults, statistical comparisons were performed with PK data from the current study (test) and adult data from population PK modeling in study GS-US-183-0145 (NCT00708162) (reference).||168.94|127.35|
70998486|NCT03127852|141503978|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||Poststudy between-group comparison of SF-36 mental component summary score.||||.73
70998487|NCT03127852|141503979|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Poststudy between-group comparison of self-reported number of hospital visits.||||.02
70998488|NCT03127852|141503979|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||Poststudy between-group comparison of self-reported emergency department visits.||||.12
70998489|NCT03127852|141503979|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||Poststudy between-group comparison of self-reported number of clinic visits.||||.39
70998490|NCT03127852|141503979|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||Poststudy between-group comparison of self-reported number of family physician visits.||||.28
70998491|NCT03127852|141503980|SUPERIORITY|||||||0.74|||||||t-test, 2 sided|||Poststudy between-group comparison of SCHFI maintenance sub-scale.||||.74
70998492|NCT03127852|141503980|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||Poststudy between-group comparison of SCHFI management sub-scale.||||.67
70998493|NCT03127852|141503980|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||Poststudy between-group comparison of SCHFI confidence sub-scale.||||.92
71100303|NCT01887600|141709234|SUPERIORITY||Least squares mean difference|1.374|||<|0.001|TWO_SIDED|95.0|0.99|1.75||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 84. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.75|0.99|<0.001
70998494|NCT03127852|141503981|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||Poststudy between-group comparison of MLHFQ total score.||||.67
70998495|NCT03127852|141503981|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||Poststudy between-group comparison of MLHFQ physical domain score.||||.43
70998496|NCT03127852|141503981|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||Poststudy between-group comparison of MLHFQ emotional domain score.||||.64
70998497|NCT03127852|141503982|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||Poststudy between-group comparison of HADS anxiety sub-scale.||||.06
70998498|NCT03127852|141503982|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||Poststudy between-group comparison of HADS depression sub-scale.||||.77
70998499|NCT03127852|141503983|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||Poststudy between-group comparison of SEMCD6.||||.13
70998500|NCT02574481|141503993|NON_INFERIORITY|A two-group Farrington-Manning test is used to test the one-sided hypothesis of non-inferiority in proportions.|||||<|0.0001||||||A two-group Farrington-Manning test is used to test the one-sided hypothesis of non-inferiority in proportions. If the P-value from the one-sided Farrington-Manning test is \<0.05, Eluvia is concluded to be non-inferior to Zilver PTX.|Farrington-Manning|||||||<0.0001
70998501|NCT02574481|141503994|NON_INFERIORITY|A two-group Farrington-Manning test is used to test the one-sided hypothesis of non-inferiority in proportions..|||||<|0.0001||||||A two-group Farrington-Manning test is used to test the one-sided hypothesis of non-inferiority in proportions. If the P-value from the one-sided Farrington-Manning test is \<0.05, Eluvia is concluded to be non-inferior to Zilver PTX.|Farrington-Manning|||||||<0.0001
70998502|NCT04134728|141504007|SUPERIORITY||Odds Ratio (OR)|1.38||||0.2868|TWO_SIDED|0.95|0.76|2.48|||Regression, Logistic|OR and corresponding 95%CI are generated from logistic regression model adjusted for Baseline, Treatment Group, Previously Failed Medical Category.||The null hypothesis is that there is no difference between 90 mg dose of GSK3196165 and placebo in the proportion of participants achieving ACR20 response at Week 12 versus the alternative hypothesis that the 90 mg dose of GSK3196165 differs from placebo in the proportion of participants with ACR20 response at Week 12||2.48|0.76|0.2868
70998503|NCT04134728|141504007|SUPERIORITY||Odds Ratio (OR)|1.75||||0.0596|TWO_SIDED|0.95|0.98|3.15|||Regression, Logistic|OR and corresponding 95%CI are generated from logistic regression model adjusted for Baseline, Treatment Group, Previously Failed Medical Category.||The null hypothesis is that there is no difference between 150 mg dose of GSK3196165 and placebo in the percentage of participants achieving ACR20 response at Week 12 versus the alternative hypothesis that the 150 mg dose of GSK3196165 differs from placebo in the percentage of participants with ACR20 response at Week 12||3.15|0.98|0.0596
70998504|NCT04134728|141504007|SUPERIORITY||Odds Ratio (OR)|2.34||||0.0049|TWO_SIDED|0.95|1.29|4.23|||Regression, Logistic|OR and corresponding 95%CI are generated from logistic regression model adjusted for Baseline, Treatment Group, Previously Failed Medical Category.||The null hypothesis is that there is no difference between 200 mg dose of Sarilumab alternating with placebo every week and placebo in the proportion of participants achieving ACR20 response at Week 12 versus the alternative hypothesis that the 200 mg dose of Sarilumab alternating with placebo every week differs from placebo in the proportion of participants with ACR20 response at Week 12||4.23|1.29|0.0049
70998505|NCT04134728|141504007|SUPERIORITY||Odds Ratio (OR)|0.59||||0.0293|TWO_SIDED|0.95|0.36|0.95|||Regression, Logistic|OR and corresponding 95%CI are generated from logistic regression model adjusted for Baseline, Treatment Group, Previously Failed Medical Category.||The null hypothesis is that there is no difference between 90 mg dose of GSK3196165 and 200 mg dose of sarilumab alternating with placebo every week in the proportion of participants achieving ACR20 response at Week 12 versus the alternative hypothesis that the 90 mg dose of GSK3196165 differs from 200 mg dose of sarilumab alternating with placebo every week in the proportion of participants with ACR20 response at Week 12||0.95|0.36|0.0293
70998506|NCT04134728|141504007|SUPERIORITY||Odds Ratio (OR)|0.75||||0.2308|TWO_SIDED|0.95|0.47|1.2|||Regression, Logistic|OR and corresponding 95%CI are generated from logistic regression model adjusted for Baseline, Treatment Group, Previously Failed Medical Category.||The null hypothesis is that there is no difference between 150 mg dose of GSK3196165 and 200 mg dose of sarilumab alternating with placebo every week in the proportion of participants achieving ACR20 response at Week 12 versus the alternative hypothesis that the 150 mg dose of GSK3196165 differs from 200 mg dose of sarilumab alternating with placebo every week in the proportion of participants with ACR20 response at Week 12||1.20|0.47|0.2308
70998507|NCT03404219|141504100|OTHER|Single group pre-post, follow-up|Mean Difference (Final Values)|2.56||||0.09|TWO_SIDED||||||General Linear Model (repeated measures)|||Single arm||||0.09
70998508|NCT02038790|141504103|SUPERIORITY_OR_OTHER||||||>|0.5|TWO_SIDED|||||Two-tailed level of significance of 0.05 and no adjustments made for the number of tests conducted.|Chi-squared|||||||>0.5000
70998509|NCT02038790|141504104|SUPERIORITY_OR_OTHER|||||||0.0196|TWO_SIDED|||||Two-tailed level of significance of 0.05 and no adjustments made for the number of tests conducted.|Chi-squared|||||||0.0196
70998510|NCT02038790|141504105|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||Two-tailed level of significance of 0.05 and no adjustments made for the number of tests conducted.|Chi-squared|||||||0.0006
70998511|NCT02038790|141504106|SUPERIORITY_OR_OTHER|||||||0.4422|TWO_SIDED|||||Two-tailed level of significance of 0.05 and no adjustments made for the number of tests conducted.|Chi-squared|||||||0.4422
70998512|NCT02038790|141504107|SUPERIORITY_OR_OTHER|||||||0.2377|TWO_SIDED||||||Chi-squared|||||||0.2377
70998513|NCT02038790|141504108|SUPERIORITY_OR_OTHER|||||||0.0603|TWO_SIDED||||||Chi-squared|||||||0.0603
70998514|NCT02038790|141504109|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.0010
70998515|NCT00438464|141504157|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70998516|NCT00438464|141504158|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.003
70998517|NCT00438464|141504159|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70998518|NCT00438464|141504160|SUPERIORITY_OR_OTHER|||||||0.805|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.805
70998519|NCT00438464|141504161|SUPERIORITY_OR_OTHER|||||||0.254|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.254
70998520|NCT00438464|141504162|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VEGF3, Within GG3||||0.70
70998521|NCT00438464|141504162|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Estrogen receptor beta (ERβ), Within GG3||||0.38
70998522|NCT00438464|141504162|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Androgen receptor (AR), Within GG3||||0.41
71041575|NCT01435824|141592101|EQUIVALENCE|Bioequivalence is assessed by means of ratios of AUC, Cmax and Tmax between the comparison group and the reference group. According to a common regulatory definition, the comparison preparation (human milk-dissolved amoxicillin in this project) is considered bioequivalent to a standard preparation (water dissolved) if 90% CIs of these ratios between the two preparations for Cmax, Tmax, AUClast and AUC∞ are within a range between 0.80 and 1.25.|mean %ratio and 90% confidence interval|106.1|||||TWO_SIDED|90.0|97.5|115.4||||||A 2x2 crossover design was chosen to examine bioequivalence of milk-based amoxicillin preparation, based on the FDA-recommended design for bioavailability studies. The recommendation suggests that 12 subjects is the minimum number of subjects acceptable for this type of design. We have decided to enrol 16 subjects to account for problems or attrition.||115.4|97.5|
71041576|NCT01435824|141592102|EQUIVALENCE|Bioequivalence is assessed by means of ratios of AUC, Cmax and Tmax between the comparison group and the reference group. According to a common regulatory definition, the comparison preparation (human milk-dissolved amoxicillin in this project) is considered bioequivalent to a standard preparation (water dissolved) if 90% CIs of these ratios between the two preparations for Cmax, Tmax, AUClast and AUC∞ are within a range between 0.80 and 1.25.|mean %ratio and 90% confidence interval|106.2|||||TWO_SIDED|90.0|97.5|115.7||||||A 2x2 crossover design was chosen to examine bioequivalence of milk-based amoxicillin preparation, based on the FDA-recommended design for bioavailability studies. The recommendation suggests that 12 subjects is the minimum number of subjects acceptable for this type of design. We have decided to enrol 16 subjects to account for problems or attrition.||115.7|97.5|
71041577|NCT01435824|141592103|EQUIVALENCE|Bioequivalence is assessed by means of ratios of AUC, Cmax and Tmax between the comparison group and the reference group. According to a common regulatory definition, the comparison preparation (human milk-dissolved amoxicillin in this project) is considered bioequivalent to a standard preparation (water dissolved) if 90% CIs of these ratios between the two preparations for Cmax, Tmax, AUClast and AUC∞ are within a range between 0.80 and 1.25.|mean %ratio and 90% confidence interval|101.3|||||TWO_SIDED|90.0|89.4|114.9||||||A 2x2 crossover design was chosen to examine bioequivalence of milk-based amoxicillin preparation, based on the FDA-recommended design for bioavailability studies. The recommendation suggests that 12 subjects is the minimum number of subjects acceptable for this type of design. We have decided to enrol 16 subjects to account for problems or attrition.||114.9|89.4|
70998523|NCT00438464|141504162|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Ki-67 protein, Within GG3||||0.75
70998524|NCT00438464|141504162|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||3-oxo-5α-steroid 4-dehydrogenase 2 (SRD5A2), Within GG3||||0.57
70998525|NCT00438464|141504162|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Ubiquitin-conjugating enzyme E2C (UBE2C), Within GG3||||0.12
70998526|NCT00438464|141504162|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Cleaved Caspase 3 (Caspase), Within GG3||||0.03
70998527|NCT00438464|141504163|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Vascular Epithelial Growth Factor (VEGF3), Within GG4||||0.45
70998528|NCT00438464|141504163|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Estrogen receptor beta (ERβ), Within GG4||||0.83
70998529|NCT00438464|141504163|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Androgen receptor (AR), Within GG4||||0.04
70998530|NCT00438464|141504163|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Ki-67 protein, Within GG4||||0.80
70998531|NCT00438464|141504163|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||3-oxo-5α-steroid 4-dehydrogenase 2 (SRD5A2), Within GG4||||0.61
70998532|NCT00438464|141504163|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||UBE2C, Within GG4||||0.86
70998533|NCT00438464|141504163|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Caspase, Within GG4||||0.02
70998534|NCT00438464|141504168|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VEGF3, Within Finasteride Arm||||0.84
70998535|NCT00438464|141504168|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||ERβ, Within Finasteride Arm||||0.36
70998536|NCT00438464|141504168|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||AR, Within Finasteride||||0.09
70998537|NCT00438464|141504168|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Ki-67 protein, Within Finasteride Arm||||0.46
70998538|NCT00438464|141504168|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||SRD5A2, Within Finasteride Arm||||0.88
70998539|NCT00438464|141504168|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||UBE2C, Within Finasteride Arm||||0.18
70998540|NCT00438464|141504168|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Caspase, Within Finasteride Arm||||<0.001
70998541|NCT00438464|141504169|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VEGF3, Within Placebo Arm||||0.32
70998542|NCT00438464|141504169|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||ERβ, Within Placebo Arm||||0.83
71041578|NCT01435824|141592104|EQUIVALENCE|Bioequivalence is assessed by means of ratios of AUC, Cmax and Tmax between the comparison group and the reference group. According to a common regulatory definition, the comparison preparation (human milk-dissolved amoxicillin in this project) is considered bioequivalent to a standard preparation (water dissolved) if 90% CIs of these ratios between the two preparations for Cmax, Tmax, AUClast and AUC∞ are within a range between 0.80 and 1.25.|mean %ratio and 90% confidence interval|107.9|||||TWO_SIDED|90.0|84.5|137.8||||||A 2x2 crossover design was chosen to examine bioequivalence of milk-based amoxicillin preparation, based on the FDA-recommended design for bioavailability studies. The recommendation suggests that 12 subjects is the minimum number of subjects acceptable for this type of design. We have decided to enrol 16 subjects to account for problems or attrition.||137.8|84.5|
71041579|NCT00117806|141592112|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Chi-squared|||||||0.008
70998543|NCT00438464|141504169|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||AR, Within Placebo Arm||||0.77
70998544|NCT00438464|141504169|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Ki-67 protein, Within Placebo Arm||||0.87
70998545|NCT00438464|141504169|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||SRD5A2, Within Placebo Arm||||0.91
70998546|NCT00438464|141504169|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||UBE2C, Within Placebo Arm||||0.90
70998547|NCT00438464|141504169|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Caspase, Within Placebo Arm||||<0.001
70998548|NCT03943446|141504174|SUPERIORITY||Estimated Difference in ER Rate|-0.1|||=|0.59|TWO_SIDED|95.0|-0.44|0.23|||Fisher Exact|||||0.23|-0.44|=0.590
70998549|NCT03943446|141504174|SUPERIORITY||Estimated difference in ERR|-0.01|||=|1|TWO_SIDED|95.0|-0.34|0.31|||Fisher Exact|||||0.31|-0.34|=1.000
71041580|NCT01765751|141592117|SUPERIORITY||Mean Difference (Final Values)|2.7|||||TWO_SIDED|95.0|-0.1|5.6|||||High vs Low group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.|||5.6|-0.1|
71041581|NCT01765751|141592117|SUPERIORITY||Mean Difference (Final Values)|3.0|||||TWO_SIDED|95.0|0.1|5.9|||||Medium vs Low group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.|||5.9|0.1|
70998550|NCT01281189|141504189|SUPERIORITY||LS Mean Difference (Final Values)|2.91||||0.8568|TWO_SIDED|95.0|-28.751|34.576|||ANCOVA|Includes treatment as a fixed effect and adjusts for baseline ALSFRS-R total score, duration from sx onset, site of onset, and use of riluzole.||||34.576|-28.751|0.8568
70998551|NCT01281189|141504190|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.8375|TWO_SIDED|95.0|0.75|1.427|||Cox Proportional Hazards model|Adjusted for baseline ALSFRS-R total score, duration from symptom onset to the first dose of study treatment, site of onset, and use of riluzole.|||Hazard Ratio (HR) (Dex/PBO)|1.427|0.750|0.8375
70998552|NCT01281189|141504191|SUPERIORITY||LS Mean Difference (Net)|0.076||||0.9019|TWO_SIDED|95.0|-1.128|1.28|||mixed-effects repeated-measures model|Mixed-effects repeated-measures model with treatment, visit, treatment-by visit interaction, baseline ALSFRS-R score, baseline-by-visit interaction|The mixed-effects repeated-measures model also adjusted for the following covariates: duration from symptom onset, site of onset, and use of riluzole.|||1.280|-1.128|0.9019
70998553|NCT01281189|141504192|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.7715|TWO_SIDED|95.0|0.801|1.348|||Cox Proportional Hazards model|Adjusted for baseline ALSFRS-R total score, duration from symptom onset to the first dose of study treatment, site of onset, and use of riluzole||||1.348|0.801|0.7715
70998554|NCT01281189|141504193|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.9033|TWO_SIDED|95.0|0.745|1.298|||Cox Proportional Hazards model|adjusted for baseline ALSFRS-R total score, duration from symptom onset to the first dose of study treatment, site of onset, and use of riluzole||||1.298|0.745|0.9033
70998555|NCT01281189|141504194|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.772|TWO_SIDED|95.0|0.789|1.192|||Cox Proportional Hazards model||Hazard ratio (Dex/PBO)|||1.192|0.789|0.7720
70998556|NCT05355818|141504195|SUPERIORITY||Diff. in proportion of responders in %|37.9|||||TWO_SIDED|||||There are no p-values when performing a Bayesian analysis. Instead, the probability that the difference in the posterior distributions is \> 0 is used.|Bayesian|Historical information from LP0133-1401 (NCT04871711)/LP0133-1402 (NCT04872101) as prior information is used.|There is no confidence interval when performing Bayesian analyses - instead a 95% credibility interval is used: 13.5% to 58.2%.|Based on the primary estimand 'composite'. Data considered non-response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data imputed as non-response.||||
70998557|NCT05355818|141504196|SUPERIORITY||Diff. in proportion of responders in %|36.4|||||TWO_SIDED|||||There are no p-values when performing a Bayesian analysis. Instead, the probability that the difference in the posterior distributions is \> 0 is used.|Bayesian||There is no confidence interval when performing Bayesian analyses - instead a 95% credibility interval is used: 12.3% to 59.9%.|Primary estimand: Composite. Data considered non-response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data imputed as non-response.||||
70998558|NCT05355818|141504197|SUPERIORITY||Diff. in proportion of responders in %|31.7|||||TWO_SIDED|||||There are no p-values when performing a Bayesian analysis. Instead, the probability that the difference in the posterior distributions is \> 0 is used.|Bayesian||There is no confidence interval when performing Bayesian analyses - instead a 95% credibility interval is used: 5.6% to 51.1%.|||||
70998559|NCT05355818|141504198|SUPERIORITY||Diff. in proportion of responders in %|31.2|||||TWO_SIDED|||||There are no p-values when performing a Bayesian analysis. Instead, the probability that the difference in the posterior distributions is \> 0 is used.|Bayesian||There is no confidence interval when performing Bayesian analyses - instead a 95% credibility interval is used: 8.7% to 49.4%|||||
70998560|NCT05355818|141504199|SUPERIORITY||Diff. in proportion of responders in %|25.1|||||TWO_SIDED|||||There are no p-values when performing a Bayesian analysis. Instead, the probability that the difference in the posterior distributions is \> 0 is used.|Bayesian||There is no confidence interval when performing Bayesian analyses - instead a 95% credibility interval is used: 3.9% to 42.3%.|Primary estimand: Composite. Data considered non-response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data imputed as non-response.||||
70998561|NCT05355818|141504200|SUPERIORITY||Risk Difference (RD)|17.47||||0.0054|TWO_SIDED|95.0|5.16|29.78|||Regression, Logistic||Risk difference estimated using logistic regression stratified by baseline IGA-CHE score.|The primary estimand using the composite strategy is used for the analysis. Data is considered non response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data is imputed as non-response.||29.78|5.16|0.0054
70998562|NCT05355818|141504201|SUPERIORITY||Risk Difference (RD)|21.21||||0.0248|TWO_SIDED|95.0|2.69|39.72|||Regression, Logistic||Risk difference estimated using logistic regression stratified by baseline IGA-CHE score.|The primary estimand using the composite strategy is used for the analysis. Data is considered non response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data is imputed as non-response.||39.72|2.69|0.0248
70998563|NCT05355818|141504202|SUPERIORITY||Risk Difference (RD)|11.08||||0.332|TWO_SIDED|95.0|-11.3|33.46|||Regression, Logistic||Risk difference estimated using logistic regression stratified by baseline IGA-CHE score.|The primary estimand using the composite strategy is used for the analysis. Data is considered non response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data is imputed as non-response.||33.46|-11.30|0.3320
70998564|NCT05355818|141504203|SUPERIORITY||Risk Difference (RD)|33.02||||0.0016|TWO_SIDED|95.0|12.51|53.52|||Regression, Logistic||Risk difference estimated using logistic regression stratified by baseline IGA-CHE score.|The primary estimand using the composite strategy is used for the analysis. Data is considered non response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data is imputed as non-response.||53.52|12.51|0.0016
70998565|NCT05355818|141504204|SUPERIORITY||Mean Difference (Net)|-2.65||||0.0038|TWO_SIDED|95.0|-4.42|-0.88|||ANCOVA|||Primary estimand: Composite. Data considered non-response by using WOCF (including the baseline value) after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data imputed using WOCF (including the baseline value).||-0.88|-4.42|0.0038
70998566|NCT00092677|141504245|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.96||||0.591||95.0|0.826|1.115|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.115|0.826|0.591
70998567|NCT00092677|141504246|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.973||||0.732||95.0|0.833|1.137|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.137|0.833|0.732
70998568|NCT00092677|141504247|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78||||0.024||95.0|0.628|0.967|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||0.967|0.628|0.024
70998569|NCT00092677|141504248|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.829||||0.344||95.0|0.563|1.222|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.222|0.563|0.344
70998570|NCT00092677|141504249|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.997||||0.968||95.0|0.842|1.179|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.179|0.842|0.968
70998571|NCT00092677|141504250|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.088||||0.771||95.0|0.617|1.917|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.917|0.617|0.771
70998572|NCT00092677|141504251|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.636||||0.147||95.0|0.345|1.173|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.173|0.345|0.147
70998573|NCT00092677|141504252|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.683||||0.015||95.0|0.503|0.929|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||0.929|0.503|0.015
70998574|NCT00092677|141504253|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.456||||||95.0|0.197|1.057||The p-value was not provided as there were less than 40 patients who reported the specific endpoint.|Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.057|0.197|
70998575|NCT00092677|141504254|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.608||||||95.0|0.199|1.86||The p-value was not provided as there were less than 40 patients who reported the specific endpoint.|Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.860|0.199|
71041582|NCT01765751|141592117|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-3.2|2.7|||||High vs Medium group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.|||2.7|-3.2|
71041583|NCT01765751|141592118|SUPERIORITY||Mean Difference (Final Values)|15.6|||||TWO_SIDED|95.0|1.6|29.7|||||High vs Low group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.|||29.7|1.6|
70998576|NCT00092677|141504255|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.124||||0.647||95.0|0.682|1.85|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.850|0.682|0.647
70998577|NCT00092677|141504256|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.036||||0.799||95.0|0.788|1.363|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.363|0.788|0.799
70998578|NCT00092677|141504257|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.667||||0.052||95.0|0.996|2.791|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||2.791|0.996|0.052
70998579|NCT00092677|141504258|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.504||||0.008||95.0|1.111|2.035|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||2.035|1.111|0.008
70998580|NCT00092677|141504259|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.029||0.829||95.0|-0.063|0.051|||ANCOVA|Model terms: treatment and baseline peak transaortic jet velocity|Direction of the Comparison: EZ/Simva 10/40 mg minus Placebo|||0.051|-0.063|0.829
70998581|NCT00092677|141504260|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-32.1|STANDARD_ERROR_OF_MEAN|0.6|<=|0.001||95.0|-33.3|-31.0|||ANOVA|Model terms: treatment|Direction of the Comparison: EZ/Simva 10/40 mg minus Placebo|||-31.0|-33.3|<=0.001
71041584|NCT01765751|141592118|SUPERIORITY||Mean Difference (Final Values)|9.8|||||TWO_SIDED|95.0|-3.7|23.3|||||Medium vs Low group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.|||23.3|-3.7|
71041585|NCT01765751|141592118|SUPERIORITY||Mean Difference (Final Values)|5.8|||||TWO_SIDED|95.0|-8.6|20.3|||||High vs Medium group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.|||20.3|-8.6|
71041586|NCT01765751|141592119|SUPERIORITY||Mean Difference (Net)|-3.9|||||TWO_SIDED|95.0|-8.1|0.4|||||Pain Interference - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Pain Interference||0.4|-8.1|
71041587|NCT01765751|141592119|SUPERIORITY||Mean Difference (Net)|1.5|||||TWO_SIDED|95.0|-2.6|5.6|||||Pain Interference - Medium vs Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Pain Interference||5.6|-2.6|
71041588|NCT01765751|141592119|SUPERIORITY||Mean Difference (Net)|-5.4|||||TWO_SIDED|95.0|-9.8|1.0|||||Pain Interference - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Pain Interference||1.0|-9.8|
71041589|NCT01765751|141592119|SUPERIORITY||Mean Difference (Net)|0.8|||||TWO_SIDED|95.0|-2.2|3.8|||||Physical Function - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Physical Function||3.8|-2.2|
71041590|NCT01765751|141592119|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-2.9|3.2|||||Physical Function - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Physical Funtion||3.2|-2.9|
71041591|NCT01765751|141592119|SUPERIORITY||Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|-2.4|3.7|||||Physical Function- High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population|Physical Function||3.7|-2.4|
71041592|NCT01765751|141592119|SUPERIORITY||Mean Difference (Net)|5.8|||||TWO_SIDED|95.0|1.1|10.5|||||Fatigue - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Fatigue||10.5|1.1|
71041593|NCT01765751|141592119|SUPERIORITY||Median Difference (Net)|3.3|||||TWO_SIDED|95.0|-1.5|8.2|||||Fatigue - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Fatigue||8.2|-1.5|
71100304|NCT01887600|141709234|SUPERIORITY||Least squares mean difference|1.171|||<|0.001|TWO_SIDED|95.0|0.79|1.55||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 88. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.55|0.79|<0.001
71041594|NCT01765751|141592119|SUPERIORITY||Mean Difference (Net)|2.5|||||TWO_SIDED|95.0|-2.3|7.3|||||Fatigue - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Fatigue||7.3|-2.3|
70998582|NCT00092677|141504261|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-50.0|STANDARD_ERROR_OF_MEAN|0.9|<=|0.001||95.0|-51.8|-48.2|||ANOVA|Model terms: treatment|Direction of the Comparison: EZ/Simva 10/40 mg minus Placebo|||-48.2|-51.8|<=0.001
70998583|NCT00092677|141504262|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.9|STANDARD_ERROR_OF_MEAN|0.8|<=|0.001||95.0|2.4|5.5|||ANOVA|Model terms: treatment|Direction of the Comparison: EZ/Simva 10/40 mg minus Placebo|||5.5|2.4|<=0.001
70998584|NCT00092677|141504263|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.0|STANDARD_ERROR_OF_MEAN|1.3|<=|0.001||95.0|-22.6|-17.3|||ANOVA|Model terms: treatment|Direction of the Comparison: EZ/Simva 10/40 mg minus Placebo|||-17.3|-22.6|<=0.001
70998585|NCT01601704|141504264|NON_INFERIORITY_OR_EQUIVALENCE|At the pre-planned 50% interim analysis, a non-inferiority analysis was conducted based on the estimated hazard ratio (NB32/Placebo) for the time to the first confirmed occurrence of MACE. The upper-bound of the 99.7% confidence interval for the hazard ratio was compared to 1.4, the non-inferiority margin.|Cox Proportional Hazard|0.88|||||TWO_SIDED|99.7|0.57|1.34|||||Hazard ratio is based on CPH model with treatment as a factor.|||1.34|0.57|
70998586|NCT01601704|141504265|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.93|||||TWO_SIDED|99.7|0.66|1.33|||||Hazard ratio is based on CPH model with treatment as a factor.|||1.33|0.66|
70998587|NCT01601704|141504266|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.5|||||TWO_SIDED|99.7|0.21|1.19|||||Hazard ratio is based on CPH model with treatment as a factor.|||1.19|0.21|
70998588|NCT01601704|141504267|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.96|||||TWO_SIDED|99.7|0.55|1.67|||||Hazard ratio is based on CPH model with treatment as a factor.|||1.67|0.55|
70998589|NCT01601704|141504268|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.04|||||TWO_SIDED|99.7|0.43|2.55|||||Hazard ratio is based on CPH model with treatment as a factor.|||2.55|0.43|
70998590|NCT01090102|141504269|SUPERIORITY_OR_OTHER|||||||0.63||||||Significant at p\<0.05|t-test, 2 sided|||||||0.63
70998591|NCT01090102|141504270|SUPERIORITY_OR_OTHER|||||||0.77||||||significant at p\<0.05|t-test, 2 sided|||||||0.77
70998592|NCT03518034|141504272|NON_INFERIORITY|Noninferiority margin in terms of HR is 1.5.|Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.78|1.17|||||HR of AndroGel to placebo and 95% CI were estimated from Cox proportional-hazards regression model, with adjustment for pre-existing CVD.|The hazard ratio (HR) and 2-sided 95% confidence interval (CI) were calculated using a Cox proportional-hazards regression model, with adjustment for pre-existing cardiovascular disease (CVD) status. In this analysis, the time to event for a participant is defined as the time from randomization to the first component event of MACE. If a subject does not experience a MACE during the study, the time is right-censored at the time of participant's last available follow-up observation.||1.17|0.78|
70998593|NCT03518034|141504274|SUPERIORITY||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.86|1.21|||||HR of AndroGel to placebo and 2-sided 95% CI were estimated from a Cox proportional-hazards regression model with adjustment of pre-existing CVD status.|The HR and 2-sided 95% CI were calculated using a Cox proportional-hazards regression model, with adjustment for pre-existing CVD status. In this analysis, the time to event for a participant is defined as the time from randomization to the first component event of CV safety endpoint. If a participant does not experience a CV safety endpoint during the study, the time is right-censored at the time of participant's last available follow-up observation.||1.21|0.86|
70998594|NCT03518034|141504275|SUPERIORITY||Hazard Ratio (HR)|1.62|||||TWO_SIDED|95.0|0.39|6.77|||||Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior cardiovascular disease (CVD).|The high grade prostate cancer endpoint was analyzed using a discrete time proportional hazard regression model with event time intervals based on scheduled visits, and adjusting for pre-existing CVD status. The HR of AndroGel to Placebo and its 2-sided 95% CI were provided.||6.77|0.39|
70998595|NCT03518034|141504276|SUPERIORITY|||||||0.011||||||P-value is derived from the omnibus likelihood-ratio chi-square test of the current model versus the null (intercept) model using linear mixed regression model.|linear mixed regression model|Omnibus likelihood-ratio chi-square test from linear mixed regression model||A linear mixed regression model was used to analyze the change in PDQ-Q4 from baseline to months 6, 12, and 24, with the dependent variable being the change in PDQ-Q4 score. The model included fixed effects for treatment, visit, and the interaction between treatment and visit, while adjusting for baseline PDQ-Q4 score and pre-existing CVD status. An unstructured covariance matrix was used to account for correlations among repeated measures within-subject.||||0.011
70998596|NCT03518034|141504276|SUPERIORITY||LS Mean of Difference|0.49|||||TWO_SIDED|95.0|0.19|0.79|||||LS mean difference (AndroGel - Placebo) at month 6 was derived from linear mixed regression model.|Month 6 (results were derived from a linear mixed regression model that had a dependent variable of the change in PDQ-Q4 from baseline to months 6, 12, and 24. The model included fixed effects for treatment, visit, and the interaction between treatment and visit, while adjusting for baseline PDQ-Q4 score and pre-existing CV disease status. Additionally, an unstructured covariance matrix was used to account for correlations among repeated measures within participants).||0.79|0.19|
70998597|NCT03518034|141504276|SUPERIORITY||LS Mean of Difference|0.47|||||TWO_SIDED|95.0|0.11|0.83|||||LS mean difference (AndroGel - Placebo) at month 12 was derived from linear mixed regression model.|Month 12 (results were derived from a linear mixed regression model that had a dependent variable of the change in PDQ-Q4 from baseline to months 6, 12, and 24. The model included fixed effects for treatment, visit, and the interaction between treatment and visit, while adjusting for baseline PDQ-Q4 score and pre-existing CV disease status. Additionally, an unstructured covariance matrix was used to account for correlations among repeated measures within participants).||0.83|0.11|
70998598|NCT03518034|141504276|SUPERIORITY||LS Mean of Difference|0.48|||||TWO_SIDED|95.0|-0.01|0.96|||||LS mean difference (AndroGel - Placebo) at month 24 was derived from linear mixed regression model.|Month 24 (results were derived from a linear mixed regression model that had a dependent variable of the change in PDQ-Q4 from baseline to months 6, 12, and 24. The model included fixed effects for treatment, visit, and the interaction between treatment and visit, while adjusting for baseline PDQ-Q4 score and pre-existing CV disease status. Additionally, an unstructured covariance matrix was used to account for correlations among repeated measures within participants).||0.96|-0.01|
71041595|NCT01765751|141592119|SUPERIORITY||Mean Difference (Net)|1.3|||||TWO_SIDED|95.0|-0.9|3.5|||||Sleep Disturbance - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Sleep Disturbance||3.5|-0.9|
71041596|NCT01765751|141592119|SUPERIORITY||Mean Difference (Net)|-1.4|||||TWO_SIDED|95.0|-3.6|0.9|||||Sleep Disturbance - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Sleep Disturbance||0.9|-3.6|
71041597|NCT01765751|141592119|SUPERIORITY||Mean Difference (Net)|2.7|||||TWO_SIDED|95.0|0.4|5.0|||||Sleep Disturbance - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Sleep Disturbance||5.0|0.4|
71100305|NCT01887600|141709234|SUPERIORITY||Least squares mean difference|1.382|||<|0.001|TWO_SIDED|95.0|0.98|1.78||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 92. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.78|0.98|<0.001
71041598|NCT01765751|141592119|SUPERIORITY||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-4.5|3.9|||||Anxiety - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Anxiety||3.9|-4.5|
71100306|NCT01887600|141709234|SUPERIORITY||Least squares mean difference|1.563|||<|0.001|TWO_SIDED|95.0|1.15|1.97||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 96. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.97|1.15|<0.001
71100307|NCT01887600|141709234|SUPERIORITY||Least squares mean difference|1.448|||<|0.001|TWO_SIDED|95.0|1.06|1.83||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 100. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.83|1.06|<0.001
71100308|NCT01887600|141709234|SUPERIORITY||Least squares mean difference|1.347|||<|0.001|TWO_SIDED|95.0|0.9|1.79||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 104. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.79|0.90|<0.001
71100309|NCT01887600|141709235|SUPERIORITY||Least squares mean difference|1.614|||<|0.001|TWO_SIDED|95.0|1.42|1.81||LSM difference p-value is for test of differences.|Mixed Models Analysis|||Change from baseline to average Hb weeks 28-36. A Mixed Model of Repeated Measures was applied using the visits up to week 36. The results were based on the estimated difference between the two treatment arms overall mean effect during week 28 to 36 period based on this MMRM model. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.81|1.42|<0.001
71100310|NCT01887600|141709236|SUPERIORITY||Least squares mean difference|1.594|||<|0.001|TWO_SIDED|95.0|1.38|1.81||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Change from baseline to average Hb weeks 44-52. A Mixed Model of Repeated Measures was applied using the visits up to week 52. The results were based on the estimated difference between the two treatment arms overall mean effect during week 44 to 52 period based on this MMRM model. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.81|1.38|<0.001
71041599|NCT01765751|141592119|SUPERIORITY||Mean Difference (Net)|1.1|||||TWO_SIDED|95.0|-2.9|5.1|||||Anxiety - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Anxiety||5.1|-2.9|
71100311|NCT01887600|141709237|SUPERIORITY||Least squares mean difference|1.452|||<|0.001|TWO_SIDED|95.0|1.1|1.8||LSM difference p-value is for test of differences.|Mixed Models Analysis|||Change from BL to average Hb weeks 96-104. A Mixed Model of Repeated Measures was applied using the visits up to week 104. The results were based on the estimated difference between the two treatment arms overall mean effect during week 96 to 104 period based on this MMRM model. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.80|1.10|<0.001
71100312|NCT01887600|141709241|SUPERIORITY||Hazard Ratio (HR)|0.945|||=|0.643|TWO_SIDED|95.0|0.74|1.2|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.20|0.74|=0.643
71100313|NCT01887600|141709243|SUPERIORITY||Hazard Ratio (HR)|0.139|||<|0.001|TWO_SIDED|95.0|0.08|0.23|||Regression, Cox|||Time to start rescue therapy within first 24 weeks. Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||0.23|0.08|<0.001
70998599|NCT03518034|141504277|SUPERIORITY||Risk Ratio (RR)|1.92|||||TWO_SIDED|95.0|0.96|3.86||||||Month 6 risk ratio of remission of LG-PDD in the AndroGel versus placebo group was estimated by a repeated measures generalized estimating equations (GEE) Poisson regression model with fixed effects for treatment, visit, treatment-visit interaction, pre- existing CVD, and an unstructured working correlation matrix to account for repeated measures at multiple visits.||3.86|0.96|
70998600|NCT03518034|141504277|SUPERIORITY||Risk Ratio (RR)|1.52|||||TWO_SIDED|95.0|0.64|3.63||||||Month 12 risk ratio of remission of LG-PDD in the AndroGel versus placebo group was estimated by a repeated measures generalized estimating equations (GEE) Poisson regression model with fixed effects for treatment, visit, treatment-visit interaction, pre- existing CVD, and an unstructured working correlation matrix to account for repeated measures at multiple visits.||3.63|0.64|
70998601|NCT03518034|141504277|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.42|1.94||||||Month 24 risk ratio of remission of LG-PDD in the AndroGel versus placebo group was estimated by a repeated measures generalized estimating equations (GEE) Poisson regression model with fixed effects for treatment, visit, treatment-visit interaction, pre- existing CVD, and an unstructured working correlation matrix to account for repeated measures at multiple visits.||1.94|0.42|
70998602|NCT03518034|141504277|SUPERIORITY|||||||0.197||||||The omnibus test p value is a test of the null hypothesis of no difference between AndroGel and placebo groups across all time points.|GEE Poisson regression model|||Risk ratio of remission of LG-PDD in the TRT versus placebo group was estimated by a repeated measures generalized estimating equations (GEE) Poisson regression model with fixed effects for treatment, visit, treatment-visit interaction, pre- existing CVD, and an unstructured working correlation matrix to account for repeated measures at multiple visits.||||0.197
70998603|NCT03518034|141504279|SUPERIORITY||Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|1.04|1.97|||||Cox proportional-hazards model.|The HR and 2-sided 95% CI were calculated using a Cox proportional-hazards regression model, with adjustment for pre-existing CVD status. In this analysis, the time to event for a subject is defined as the time from randomization to the first occurrence of a clinical fracture. If a subject does not experience a clinic fracture during the study, the follow-up time is right-censored at the time of subject's last available follow-up observation.||1.97|1.04|
70998604|NCT03518034|141504280|OTHER|||||||0.002||||||p-value is from an omnibus likelihood-ratio chi-square test of the current model versus the null (intercept) model using repeated measure log-binomial regression.|omnibus likelihood-ratio chi-square test|||Repeated measures log-binomial regression with effects for treatment, visit, treatment-by-visit interaction, and adjusted for pre-existing CVD, and an unstructured covariance matrix to account for correlations among repeated measures within-subject.||||0.002
70998605|NCT03518034|141504281|SUPERIORITY|||||||0.494||||||P-value is from an omnibus likelihood-ratio chi-square test of the current model versus the null (intercept) model using repeated measure log-binomial regression.|Repeated measures log-binomial regr.|||The risk ratio of progression to diabetes in the AndroGel versus placebo group was estimated by a repeated measures log-binomial regression with fixed effects for treatment, visit, treatment-visit interaction, and pre-existing CVD, and an unstructured covariance matrix to account for correlations among repeated measures within-subject.||||0.494
70998606|NCT03518034|141504282|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.78|1.23|||||Cox proportional-hazards model adjusting for prior CVD.|||1.23|0.78|
70998607|NCT03518034|141504283|SUPERIORITY||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.76|1.62|||||Cox proportional-hazards model adjusting for prior CVD.|||1.62|0.76|
70998608|NCT03518034|141504284|SUPERIORITY||Hazard Ratio (HR)|1.46|||||TWO_SIDED|95.0|0.92|2.32|||||Cox proportional-hazards model adjusting for prior CVD.|||2.32|0.92|
70998609|NCT03518034|141504285|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.56|1.51|||||Cox proportional-hazards model adjusting for prior CVD.|||1.51|0.56|
70998610|NCT03518034|141504286|SUPERIORITY||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.55|2.31|||||Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior CVD.|||2.31|0.55|
70998611|NCT03518034|141504287|SUPERIORITY||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.47|2.42|||||Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior CVD.|||2.42|0.47|
70998612|NCT03518034|141504288|SUPERIORITY||Hazard Ratio (HR)|1.25|||||TWO_SIDED|95.0|0.65|2.41|||||Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior CVD.|||2.41|0.65|
70998613|NCT03518034|141504289|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.87|1.54|||||Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior CVD.|||1.54|0.87|
70998614|NCT03518034|141504290|SUPERIORITY||Hazard Ratio (HR)|1.91|||||TWO_SIDED|95.0|0.95|3.84|||||Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior CVD.|||3.84|0.95|
70998615|NCT00010803|141504293|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|1.12||||0.21|TWO_SIDED|95.0|0.94|1.33|||Log Rank|Time to dementia in Ginkgo vs placebo groups. The Cox proportional hazards model was used to compute hazard ratios and log-rank tests.||The null hypothesis is that the instantaneous hazard rate for Ginkgo biloba and placebo are the same. Assumptions were based on 4%/yr dementia and 6%/yr mortality and dropout combined. A sample size of 3000 with an average follow up of 5 years resulted in 96% power to detecting a 30% reduction in the rate of dementia at a 2-sided significance level of 0.5.||1.33|0.94|0.21
70998616|NCT00010803|141504294|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|1.04||||0.7|TWO_SIDED|95.0|0.85|1.27|||Log Rank|||Total Mortality||1.27|0.85|0.70
70998617|NCT00010803|141504294|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|1.06||||0.78|TWO_SIDED|95.0|0.7|1.62|||Log Rank|||Atherosclerotic CHD mortality||1.62|0.70|0.78
70998618|NCT00010803|141504294|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|1.12||||0.54|TWO_SIDED|95.0|0.79|1.58|||Log Rank|||Incident Myocardial Infarction||1.58|0.79|0.54
71041600|NCT01765751|141592119|SUPERIORITY||Mean Difference (Net)|-1.4|||||TWO_SIDED|95.0|-5.7|2.9|||||Anxiety - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Anxiety||2.9|-5.7|
71041601|NCT01765751|141592119|SUPERIORITY||Mean Difference (Net)|-2.8|||||TWO_SIDED|95.0|-6.7|0.6|||||Depression - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Depression||0.6|-6.7|
70998619|NCT00010803|141504294|NON_INFERIORITY_OR_EQUIVALENCE|Previously Provided|Hazard Ratio (HR)|0.84||||0.32|TWO_SIDED|95.0|0.61|1.18|||Log Rank|||Incident Angina||1.18|0.61|0.32
71041602|NCT01765751|141592119|SUPERIORITY||Mean Difference (Net)|-0.8|||||TWO_SIDED|95.0|-4.1|2.6|||||Depression - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Depression||2.6|-4.1|
71100314|NCT01887600|141709244|SUPERIORITY||Cox Proportional Hazard|0.343|||<|0.001|TWO_SIDED|95.0|0.21|0.55|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||0.55|0.21|<0.001
71100315|NCT01887600|141709245|SUPERIORITY||Least squares mean difference|-0.045|||=|0.128|TWO_SIDED|95.0|-0.1|0.01|||ANCOVA|||The Analysis of Covariance (ANCOVA) model was applied including treatment as fixed factor, region and history of CV disease as class factors and baseline Hb, baseline eGFR as continuous covariates.||0.01|-0.10|=0.128
71100316|NCT01887600|141709246|SUPERIORITY||Least squares mean difference|-10.429|||=|0.183|TWO_SIDED|95.0|-25.81|4.95|||ANCOVA|||The Analysis of Covariance (ANCOVA) model was applied included treatment arm, region, CV history as categorical variables and baseline Hb and baseline eGFR as continuous variables.||4.95|-25.81|=0.183
71100317|NCT01887600|141709247|SUPERIORITY||Hazard Ratio (HR)|0.101|||<|0.001|TWO_SIDED|95.0|0.06|0.17|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||0.17|0.06|<0.001
71100318|NCT01887600|141709248|SUPERIORITY||Hazard Ratio (HR)|0.538|||=|0.045|TWO_SIDED|95.0|0.29|0.99|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||0.99|0.29|=0.045
71100319|NCT01887600|141709257|SUPERIORITY||Least squares mean difference|0.374|||=|0.475|TWO_SIDED|95.0|-0.65|1.4||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||The Mixed Model of Repeated Measures included treatment, visit (week 8, week 12 and week 28), visit by treatment interaction, region and history of CV disease as fixed class factors and baseline SF-36 PCS, baseline Hb, baseline eGFR as continuous covariates.||1.40|-0.65|=0.475
71100320|NCT01887600|141709258|SUPERIORITY||Least squares mean difference|1.704|||=|0.047|TWO_SIDED|95.0|0.02|3.38||LSM difference p-value is for test of differences|Mixed Models Analysis|||A Mixed Model of Repeated Measures was applied using the visits up to week 28. The model includes treatment, visit (week 8, week 12 and week 28), visit by treatment interaction, region and history of CV disease as fixed class factors and baseline FACT-An Ans, baseline Hb, baseline eGFR as continuous covariates. Baseline FACT-An Ans is defined as the FACT-An Ans value on day 1.||3.38|0.02|=0.047
70998620|NCT00010803|141504294|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|0.94||||0.66|TWO_SIDED|95.0|0.72|1.23|||Log Rank|||Incident CHD||1.23|0.72|0.66
70998621|NCT00010803|141504294|NON_INFERIORITY_OR_EQUIVALENCE|Previously Provided|Hazard Ratio (HR)|0.91||||0.48|TWO_SIDED|95.0|0.71|1.18|||Log Rank|||Incident CHF||1.18|0.71|0.48
70998622|NCT00010803|141504294|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|0.87||||0.25|TWO_SIDED|95.0|0.52|1.45|||Log Rank|||Incident Stroke||1.45|0.52|0.25
70998623|NCT00010803|141504294|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|0.87||||0.59|TWO_SIDED|95.0|0.52|1.45|||Log Rank|||Incident TIA||1.45|0.52|0.59
71041603|NCT01765751|141592119|SUPERIORITY||Mean Difference (Net)|-2.0|||||TWO_SIDED|95.0|-5.4|1.4|||||Depression - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Depression||1.4|-5.4|
71041604|NCT01765751|141592119|SUPERIORITY||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-4.5|4.9|||||Satisfaction with Social Role - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Satisfaction with Social Role||4.9|-4.5|
71100321|NCT01887600|141709259|SUPERIORITY||Least squares mean difference|2.086|||=|0.225|TWO_SIDED|95.0|-1.29|5.46|||Mixed Models Analysis|||A Mixed Model of Repeated Measures was applied using the visits up to week 28. The results were based on the estimated difference between the two treatment arms overall mean effect during week 12 to 28 period based on this MMRM model.The model includes treatment, visit (week8, week12 and week28), visit by treatment interaction, region and history of CV disease as fixed class factors and baseline FACT-An Total Score, baseline Hb, baseline eGFR as continuous covariates.||5.46|-1.29|=0.225
71100322|NCT01887600|141709270|SUPERIORITY||Hazard Ratio (HR)|0.995|||=|0.973|TWO_SIDED|95.0|0.75|1.32|||Regression, Cox|||Time to doubling of serum Creatinine. Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.32|0.75|=0.973
71100323|NCT01887600|141709271|SUPERIORITY||Hazard Ratio (HR)|0.995|||=|0.972|TWO_SIDED|95.0|0.76|1.3|||Regression, Cox|||Time to CKD progression. Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.30|0.76|=0.972
70998624|NCT00010803|141504294|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Cox Proportional Hazard|1.12||||0.42|TWO_SIDED|95.0|0.84|1.5|||Log Rank|||Incident CVD||1.50|0.84|0.42
70998625|NCT00010803|141504294|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.8|1.25|||Log Rank|||Total CHD and CVD combined||1.25|0.80|0.98
71100324|NCT01887600|141709272|SUPERIORITY||Hazard Ratio (HR)|0.905|||=|0.439|TWO_SIDED|95.0|0.7|1.16|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.16|0.70|=0.439
71100325|NCT03688139|141709273|SUPERIORITY||difference in slopes|0.23||||0.08|TWO_SIDED||||||Mixed Models Analysis|||||||.08
71100326|NCT03688139|141709273|OTHER|This analysis tested whether the course of LPP was associated with the course of BADS over the 9-week treatment period in the Engage group.|Slope|0.03||||0.14|TWO_SIDED||||||Mixed Models Analysis|||||||.14
71100327|NCT03688139|141709274|SUPERIORITY||difference in slopes|-0.06||||0.69|TWO_SIDED||||||Mixed Models Analysis|||||||.69
71100328|NCT03688139|141709275|SUPERIORITY||difference in slopes|-0.03||||0.69|TWO_SIDED||||||Mixed Models Analysis|||||||.69
71041605|NCT01765751|141592119|SUPERIORITY||Mean Difference (Net)|3.0|||||TWO_SIDED|95.0|-1.8|7.7|||||Satisfaction with Social Role - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Satisfaction with Social Role||7.7|-1.8|
71041606|NCT01765751|141592119|SUPERIORITY||Mean Difference (Net)|-2.8|||||TWO_SIDED|95.0|-7.6|2.0|||||Satisfaction with Social Role - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Satisfaction with Social Role||2.0|-7.6|
71041607|NCT02459418|141592125|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline corrected AUC(0-last) were used to assess bioequivalence between Gonal-f® RFF and AFOLIA using the bioequivalence interval of 80.00% to 125.00%.|Geometric LS Mean Ratio|164.96|||||TWO_SIDED|90.0|137.82|197.45||||||A mixed-effects analysis of variance (ANOVA) model with sequence, treatment and period as fixed effects, and subject nested within sequence as random effect was used. Least squares (LS) means and 90% confidence intervals (CIs) for treatment differences on log-scale were obtained and back transformed to provide geometric LS mean ratios of AFOLIA over Gonal-f® RFF.||197.45|137.82|
71041608|NCT02459418|141592126|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline corrected Cmax were used to assess bioequivalence between Gonal-f® RFF and AFOLIA using the bioequivalence interval of 80.00% to 125.00%.|Geometric LS Mean Ratio|123.15|||||TWO_SIDED|90.0|108.12|140.28||||||An ANOVA model with sequence, treatment and period as fixed effects, and subject nested within sequence as random effect was used. LS means and 90% CIs for treatment differences on log-scale were obtained and back-transformed to provide geometric LS mean ratios of AFOLIA over Gonal-f® RFF.||140.28|108.12|
71041609|NCT02459418|141592127|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline corrected AUC(0-∞) were used to assess bioequivalence between Gonal-f® RFF and AFOLIA using the bioequivalence interval of 80.00% to 125.00%.|Geometric LS mean ratio|133.68|||||TWO_SIDED|90.0|102.42|174.49||||||An ANOVA model with sequence, treatment and period as fixed effects, and subject nested within sequence as random effect was used. LS means and 90% CIs for treatment differences on log-scale were obtained and back-transformed to provide geometric LS mean ratios of AFOLIA over Gonal-f® RFF.||174.49|102.42|
71041610|NCT02459418|141592128|OTHER||Median Difference (Net)|7.5|||||TWO_SIDED|90.0|4.5|11.5||||||Non-transformed Tmax was tested using the non-parametric Wilcoxon signed rank test to assess the differences between Gonal-f® RFF and AFOLIA. Median differences and corresponding 90% CIs were calculated using an exact Hodges-Lehmann estimate.||11.5|4.5|
71041611|NCT02459418|141592130|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline corrected AUC(0-last) were used to assess bioequivalence between Gonal-f® RFF and AFOLIA using the bioequivalence interval of 80.00% to 125.00%.|Geometric LS Mean Ratio|163.0|||||TWO_SIDED|90.0|94.0|282.67||||||An ANOVA model with sequence, treatment and period as fixed effects, and subject nested within sequence as random effect was used. LS means and 90% CIs for treatment differences on log-scale were obtained and back-transformed to provide geometric LS mean ratios of AFOLIA over Gonal-f® RFF.||282.67|94|
71041612|NCT02459418|141592131|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline corrected Cmax were used to assess bioequivalence between Gonal-f® RFF and AFOLIA using the bioequivalence interval of 80.00% to 125.00%.|Geometric LS Mean Ratio|177.17|||||TWO_SIDED|90.0|125.65|249.81||||||An ANOVA model with sequence, treatment and period as fixed effects, and subject nested within sequence as random effect was used. LS means and 90% CIs for treatment differences on log-scale were obtained and back-transformed to provide geometric LS mean ratios of AFOLIA over Gonal-f® RFF.||249.81|125.65|
71041613|NCT02459418|141592132|OTHER||Median Difference (Net)|2.14|||||TWO_SIDED|90.0|-9.91|12.29||||||Non-transformed Tmax was tested using the non-parametric Wilcoxon signed rank test to assess the differences between Gonal-f® RFF and AFOLIA. Median difference and corresponding 90% CIs were was calculated using an Exact Hodges-Lehmann estimate with an exact confidence interval.||12.29|-9.91|
71041614|NCT01848210|141592143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.65||||0.531|TWO_SIDED|95.0|-19.81|10.51|||Regression, Linear|||||10.51|-19.81|0.531
71041615|NCT02426541|141592150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68||||0.3794|TWO_SIDED|95.0|-2.18|5.54|||ANCOVA|Adjusted for sex and baseline||||5.54|-2.18|0.3794
71041616|NCT02426541|141592151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32||||0.5317|TWO_SIDED|95.0|-5.6|2.96|||ANCOVA|Adjusted for sex and baseline||||2.96|-5.60|0.5317
71100329|NCT03688139|141709276|SUPERIORITY||difference in slopes|-0.45||||0.39|TWO_SIDED||||||Mixed Models Analysis|||||||.39
71100330|NCT03688139|141709277|OTHER|This analysis tested the hypothesis that change in LPP for each assessment interval would predict severity of anhedonia at the next assessment in Engage but not in Supportive Therapy.|difference in slopes|-0.1||||0.58|TWO_SIDED||||||Mixed Models Analysis|||||||.58
71041617|NCT02426541|141592152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003||||0.9984|TWO_SIDED|95.0|-3.07|3.07|||ANCOVA|Adjusted for sex and baseline||||3.07|-3.07|0.9984
71041618|NCT00745134|141592155|OTHER|||||||0.33|||||||ANOVA|||||||0.33
71041619|NCT02327325|141592181|SUPERIORITY||Mean Difference (Final Values)|-2.94||||0.08|TWO_SIDED|95.0|-6.24|0.35|||Mixed Models Analysis|||This is the comparison between physical activity only and the wait list group. Rejection of the null hypothesis means that the physical activity group had greater improvement than the wait list group.||0.35|-6.24|0.08
71100331|NCT03688139|141709277|OTHER|This analysis tested the hypothesis that change in SHAPS for each assessment interval would predict severity of anhedonia at the next assessment in Engage but not in Supportive Therapy.|difference in slopes|0.0||||0.96|TWO_SIDED||||||Mixed Models Analysis|||||||.96
71100332|NCT02470377|141709278|SUPERIORITY|The hypothesis was that either Target 1 (Occipital) or Target 2 (Vermis) would be more effective than the control target (Cerebellar hemisphere) but that there may be baseline differences in participants who chose Target 1 vs Target 2.||||||0.0439||||||Only p-values \<0.05 were considered significant|ANOVA|One way ANOVA, immediate DHI changes used for calculation.||This was an N-of-1 pilot study in which all participants received one session of each of 3 targets and chose which of the 3 led to the most acute reduction in intensity of rocking. The participants were treated with the target that they chose and then completed post stimulation diaries.||||0.0439
70998626|NCT00010803|141504295|SUPERIORITY_OR_OTHER||Treatment X Time interaction|-0.002||||0.65|TWO_SIDED|95.0|-0.009|0.005|||Mixed Models Analysis|||Linear mixed models comparing rates of change in global cognition scores (z-scores) by treatment group||0.005|-0.009|.65
70998627|NCT01019252|141504296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.24|||<|0.0001|TWO_SIDED|95.0|3.28|7.21|||Mixed Models Analysis|A longitudinal general linear mixed effects model was used.||||7.21|3.28|<.0001
70998628|NCT01019252|141504297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17|||<|0.0001|TWO_SIDED|95.0|0.94|1.39|||Mixed Models Analysis|A longitudinal general linear mixed effects model was used.||||1.39|.94|<.0001
71041620|NCT02327325|141592181|SUPERIORITY||Mean Difference (Final Values)|-3.26||||0.06|TWO_SIDED|95.0|-6.69|0.06|||Mixed Models Analysis|||This is the comparison of the PA \& CBT group to the wait list group. Rejection of the null hypothesis means that the PA + CBT group was superior on this outcome to the wait list group.||0.06|-6.69|0.06
71041621|NCT02327325|141592182|SUPERIORITY||Mean Difference (Net)|-6.11||||0.07|TWO_SIDED|95.0|-12.85|0.64|||Mixed Models Analysis|||This is the comparison of the PA only group with the wait list control. Rejection of the null hypothesis means that the PA group was superior to the wait list group.||0.64|-12.85|0.07
71041622|NCT02327325|141592182|SUPERIORITY||Mean Difference (Final Values)|-4.1||||0.28|TWO_SIDED|95.0|-11.69|3.48|||Mixed Models Analysis|||This is the comparison of the PA + CBT only group with the wait list control. Rejection of the null hypothesis means that the PA + CBT group was superior to the wait list group.||3.48|-11.69|0.28
71041623|NCT02327325|141592183|SUPERIORITY||Mean Difference (Final Values)|3.64||||0.097|TWO_SIDED|95.0|-0.69|7.96|||Mixed Models Analysis|||This is the comparison of the PA only group with the wait list control. Rejection of the null hypothesis means that the PA group was superior to the wait list group.||7.96|-0.69|0.097
71041624|NCT02327325|141592183|SUPERIORITY||Mean Difference (Final Values)|2.91||||0.196|TWO_SIDED|95.0|-1.55|7.39|||Mixed Models Analysis|||This is the comparison of the PA+CBT group with the wait list control. Rejection of the null hypothesis means that the PA+CBT group was superior to the wait list group.||7.39|-1.55|0.196
71100333|NCT02470377|141709279|SUPERIORITY|The hypothesis was that either Target 1 (Occipital) or Target 2 (Vermis) would be more effective than the control target (Cerebellar hemisphere) but that there may be baseline differences in participants who chose Target 1 vs Target 2.||||||0.0316|||||||ANOVA|One way ANOVA, immediate MBRS changes used for calculation.||This was an N-of-1 pilot study in which all participants received one session of each of 3 targets and chose which of the 3 led to the most acute reduction in intensity of rocking. The participants were treated with the target that they chose and then completed post stimulation diaries.||||0.0316
71100334|NCT02470377|141709280|SUPERIORITY|The hypothesis was that either Target 1 (Occipital) or Target 2 (Vermis) would be more effective than the control target (Cerebellar hemisphere) but that there may be baseline differences in participants who chose Target 1 vs Target 2.||||||0.1754|||||||ANOVA|One way ANOVA, immediate HADS changes used for calculation.||This was an N-of-1 pilot study in which all participants received one session of each of 3 targets and chose which of the 3 led to the most acute reduction in intensity of rocking. The participants were treated with the target that they chose and then completed post stimulation diaries.||||0.1754
71100335|NCT00655356|141709301|SUPERIORITY_OR_OTHER||||||<|1e-05|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Stratified by combined treatment site.||A 5% level of significance was used as the threshold for determination of statistical significance, and all tests were two-tailed. the effect size and associated 95% confidence interval (CI) are provided for all comparative efficacy outcomes. Primary analysis of the two co-primary efficacy endpoints and the secondary efficacy endpoints were performed on the ITT population.||||<.00001
70998629|NCT01019252|141504298|SUPERIORITY||Mean Difference (Net)|10.93|||<|0.0001|TWO_SIDED|95.0|8.93|12.93|||Mixed Models Analysis|A longitudinal general linear mixed effects model was used.||||12.93|8.93|<.0001
70998630|NCT00792701|141504322|OTHER|Correlation|Correlation Coefficient|0.39||||0.003|TWO_SIDED||||||t-test, 2 sided|||||||0.003
70998631|NCT00792701|141504325|SUPERIORITY_OR_OTHER_LEGACY||Correlation Coefficient|0.39||||0.0003|TWO_SIDED||||||Chi-squared|||Comparing RRM1 levels and ERCC1 levels between all patients.||||.0003
70998632|NCT02157168|141504453|SUPERIORITY|||||||0.624||||||This comparison reflects intent to treat and is the main comparison in the study.|Chi-squared|||CG and IG (IG1+IG2)||||0.624
70998633|NCT02157168|141504453|SUPERIORITY|||||||0.001||||||This comparison could be considered to be a per protocol analysis. Note, however, that the IG1 group was self-selected.|Chi-squared|||||||0.001
71041625|NCT02327325|141592184|SUPERIORITY||Mean Difference (Final Values)|-4.1|||<|0.01|TWO_SIDED|95.0|-6.85|-1.34|||Mixed Models Analysis|||This is the comparison of the PA only group with the wait list control. Rejection of the null hypothesis means that the PA group was superior to the wait list group.||-1.34|-6.85|<0.01
70998634|NCT02157168|141504454|SUPERIORITY|||||||0.278||||||This comparison reflects intent to treat and compares the two randomized groups CG and IG (IG1+IG2).|Chi-squared|||CG and IG (IG1+IG2)||||0.278
70998635|NCT02157168|141504454|SUPERIORITY|||||||0.056||||||This comparison could be considered to be a per protocol analysis. Note, however, that the IG1 group was self-selected.|Chi-squared|||||||0.056
70998636|NCT02157168|141504455|SUPERIORITY|||||||0.889||||||This comparison reflects intent to treat and compares the two randomized groups CG and IG (IG1+IG2).|Chi-squared|||CG and IG (IG1+IG2)||||0.889
70998637|NCT02157168|141504455|SUPERIORITY|||||||0.691||||||This comparison could be considered to be a per protocol analysis. Note, however, that the IG1 group was self-selected.|Chi-squared|||||||0.691
71041626|NCT02327325|141592184|SUPERIORITY||Mean Difference (Final Values)|-1.99||||0.17|TWO_SIDED|95.0|-4.85|0.86|||Mixed Models Analysis|||This is the comparison of the PA + CBT only group with the wait list control. Rejection of the null hypothesis means that the PA + CBT group was superior to the wait list group.||0.86|-4.85|0.17
70998638|NCT02157168|141504456|SUPERIORITY|||||||0.741||||||This comparison reflects intent to treat and compares the two randomized groups CG and IG (IG1+IG2).|Chi-squared|||CG and IG (IG1+IG2)||||0.741
70998639|NCT02157168|141504456|SUPERIORITY|||||||0.966||||||This comparison could be considered to be a per protocol analysis. Note, however, that the IG1 group was self-selected.|Chi-squared|||||||0.966
70998640|NCT02157168|141504457|SUPERIORITY|||||||0.117||||||This comparison captures the change over the intervention period.|Chi-squared|||||||.117
70998641|NCT02157168|141504457|SUPERIORITY|||||||0.638||||||This comparison is an indication of whether the change seen between baseline and 6 months in the IG1 was due to the intervention or simply due to 6 months' enrollment.|Chi-squared|||||||.638
70998642|NCT02781454|141504470|SUPERIORITY||linear contrast active vs placebo|-5.558||||0.039|TWO_SIDED|95.0|-10.8|-0.315|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||-0.315|-10.80|0.039
70998643|NCT02781454|141504471|SUPERIORITY||linear contrast active vs placebo|0.792||||0.332|TWO_SIDED|95.0|0.484|1.296||linear contrast active vs placebo|Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo ratio of week 4 to week 0||1.296|0.484|0.332
70998644|NCT02781454|141504472|SUPERIORITY||linear contrast active vs placebo|0.411||||0.013|TWO_SIDED|95.0|0.208|0.81|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo ratio of week 4 to week 0||0.810|0.208|0.013
70998645|NCT02781454|141504473|SUPERIORITY||linear contrast active vs placebo|0.343||||0.986|TWO_SIDED|95.0|-41.36|42.042|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||42.042|-41.36|0.986
70998646|NCT02781454|141504474|SUPERIORITY||linear contrast active vs placebo|0.994||||0.915|TWO_SIDED|95.0|0.876|1.126|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo ratio of week 4 to week 0||1.126|0.876|0.915
70998647|NCT02781454|141504475|SUPERIORITY||linear contrast active vs placebo|1.089||||0.694|TWO_SIDED|95.0|-4.609|6.786|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||6.786|-4.609|0.694
70998648|NCT02781454|141504476|SUPERIORITY||linear contrast active vs placebo|0.242||||0.969|TWO_SIDED|95.0|-12.64|13.126|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||13.126|-12.64|0.969
70998649|NCT02781454|141504477|SUPERIORITY||linear contrast active vs placebo|2.597||||0.323|TWO_SIDED|95.0|-2.772|7.966|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||7.966|-2.772|0.323
71041627|NCT02327325|141592185|SUPERIORITY||Median Difference (Final Values)|0.16||||0.95|TWO_SIDED|95.0|-4.86|5.19|||Mixed Models Analysis|||This is the comparison of the PA only group with the wait list control. Rejection of the null hypothesis means that the PA group was superior to the wait list group.||5.19|-4.86|0.95
70998650|NCT02781454|141504478|SUPERIORITY||linear contrast active vs placebo|-2.017||||0.273|TWO_SIDED|95.0|-5.767|1.733|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||1.733|-5.767|0.273
70998651|NCT02781454|141504479|SUPERIORITY||linear contrast active vs placebo|0.708||||0.713|TWO_SIDED|95.0|0.111|4.535|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo||4.535|0.111|0.713
70998652|NCT02781454|141504481|SUPERIORITY||linear contrast active vs placebo|-0.399||||0.601|TWO_SIDED|95.0|-1.966|1.169|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||1.169|-1.966|0.601
70998653|NCT02781454|141504482|SUPERIORITY||linear contrast active vs placebo|-2.734||||0.285|TWO_SIDED|95.0|-7.938|2.471|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||2.471|-7.938|0.285
70998654|NCT02372097|141504488|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two tablets of SYR-472 25 mg and 1 tablet of SYR-472 50 mg were considered bioequivalent if 90% CI of the mean differences of natural log-transformed AUC(0-168) of SYR-472Z was within the range of ln(0.80) to ln(1.25) or within the range of ln(0.9) to ln(1.11) and the results of dissolution test satisfied the requirement.|Least square (LS) mean difference|-0.017|||||TWO_SIDED|90.0|-0.0344|0.0004||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with the natural logarithms of the AUC(0-168) as a dependent variable, and product, group and period as fixed effects.||0.0004|-0.0344|
70998655|NCT02372097|141504489|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two tablets of SYR-472 25 mg and 1 tablet of SYR-472 50 mg were considered bioequivalent if 90% CI of the mean differences of natural log-transformed Cmax of SYR-472Z was within the range of ln(0.80) to ln(1.25) or within the range of ln(0.9) to ln(1.11) and the results of dissolution test satisfied the requirement.|LS mean difference|-0.1292|||||TWO_SIDED|90.0|-0.2177|-0.0406||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with the natural logarithms of the Cmax as a dependent variable, and product, group and period as fixed effects.||-0.0406|-0.2177|
70998656|NCT02372097|141504490|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.021||||||90.0|-0.0362|-0.0058||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with the natural logarithms of the AUC(0-inf) as a dependent variable, and product, group and period as fixed effects.||-0.0058|-0.0362|
70998657|NCT02372097|141504491|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.375|||||TWO_SIDED|90.0|-0.1452|0.8952||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with Tmax as a dependent variable, and product, group and period as fixed effects.||0.8952|-0.1452|
70998658|NCT02372097|141504492|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.0168|||||TWO_SIDED|90.0|-0.0504|0.0169||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with the natural logarithms of the MRT as a dependent variable, and product, group and period as fixed effects.||0.0169|-0.0504|
71041628|NCT02327325|141592185|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.97|TWO_SIDED|95.0|-7.07|1.07|||Mixed Models Analysis|||This is the comparison of the PA+CBT group with the wait list control. Rejection of the null hypothesis means that the PA+CBT group was superior to the wait list group.||1.07|-7.07|0.97
71041629|NCT01573533|141592290|SUPERIORITY|||||||0.49|||||||ANOVA|||Baseline vs 12 months||||0.49
71041630|NCT01573533|141592291|SUPERIORITY|||||||0.41|||||||ANOVA|||Baseline vs 12 months||||0.41
71100336|NCT00655356|141709302|SUPERIORITY_OR_OTHER|||||||0.0075|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Stratified by combined treatment site.||A 5% level of significance was used as the threshold for determination of statistical significance, and all tests were two-tailed. the effect size and associated 95% confidence interval (CI) are provided for all comparative efficacy outcomes. Primary analysis of the two co-primary efficacy endpoints and the secondary efficacy endpoints were performed on the ITT population.||||.0075
71100337|NCT02496156|141709308|SUPERIORITY||||||<|0.39||||||This is a computed p-value.|Mixed Models Analysis|||Missing data treatment was done using multiple imputation methods when data were determined to be Missing Completely at Random or Missing at Random. Assumptions underlying each statistical test were evaluated before proceeding with specific analyses.|For each outcome, a linear mixed effects model was fit; with the exception of the Knowledge test where a linear model was fit. Separate models were fit for Parents and adolescents except for HbA1C. The predictor variable is treatment group (SMDM vs. UCP). Covariates are gender, age, social economic status, and family structure as determined by (number of siblings and of caregivers in the home). A random intercept was fit for each subject across the longitudinal data. To accommodate missing values multiple imputation methodology was applied to the data, resulting in five imputed datasets. For each imputed dataset, a linear mixed effects model (or linear model for Knowledge Test) was fit; the resulting five models were pooled into a final model and summary statistics are presented. A two-sided Wald's t test determined significance of covariates. The significance level was 0.05. Appropriate model diagnostics were performed to assess model fit.|||<0.39
71100338|NCT02496156|141709309|SUPERIORITY||||||>|0.05||||||Computed p-value exceeded the .05 level of significance.|Mixed Models Analysis||||For each outcome, a linear mixed effects model was fit; with the exception of the Knowledge test where a linear model was fit. Separate models were fit for Parents and adolescents except for HbA1C. The predictor variable is treatment group (SMDM vs. UCP). Covariates are gender, age, social economic status, and family structure as determined by (number of siblings and of caregivers in the home). A random intercept was fit for each subject across the longitudinal data. To accommodate missing values multiple imputation methodology was applied to the data, resulting in five imputed datasets. For each imputed dataset, a linear mixed effects model (or linear model for Knowledge Test) was fit; the resulting five models were pooled into a final model and summary statistics are presented. A two-sided Wald's t test determined significance of covariates. The significance level was 0.05. Appropriate model diagnostics were performed to assess model fit.|||>0.05
70998659|NCT02372097|141504493|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.1099|||||TWO_SIDED|90.0|0.0235|0.1963||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with the natural logarithms of the λz as a dependent variable, and product, group and period as fixed effects.||0.1963|0.0235|
70998660|NCT01957787|141504541|OTHER|||||||0.41||||||Estimates of the log odds and Wald standard error from a random effects logistic regression model were combined across imputed datasets for reference.|Random effects logistic regression model|||The null hypothesis was tested comparing the lower bound of the Wald 97.5% 1-sided confidence interval for the estimated rate of local tumor control to the performance goal of 84.0%. If the lower bound was greater than 84.0%, the null hypothesis was rejected and the endpoint was considered met.||||0.410
70998661|NCT01412060|141504565|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45||||0.001|TWO_SIDED|95.0|0.28|0.73|||Log Rank||Hazard ratio (cariprazine 3-9 mg vs placebo) is based on Cox proportional hazards regression model, with treatment group as an explanatory variable.|||0.73|0.28|0.0010
71041631|NCT01573533|141592292|SUPERIORITY|||||||0.06|||||||ANOVA|||Baseline vs 12 months||||0.06
71041632|NCT00809965|141592314|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.02|TWO_SIDED|95.0|0.72|0.97|||Log Rank||Based upon the Cox proportional hazards model|||0.97|0.72|0.020
71041633|NCT00809965|141592314|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.028|TWO_SIDED|95.0|0.73|0.98|||Log Rank||Based upon the Cox proportional hazards model|||0.98|0.73|0.028
71041634|NCT00809965|141592315|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.016|TWO_SIDED|95.0|0.72|0.97|||Log Rank||Based on the Cox proportional hazards model|||0.97|0.72|0.016
71041635|NCT00809965|141592315|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.025|TWO_SIDED|95.0|0.73|0.98|||Log Rank||Based on the Cox proportional hazards model|||0.98|0.73|0.025
71041636|NCT00809965|141592316|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.32|TWO_SIDED|95.0|0.81|1.07|||Log Rank||Based upon the Cox proportional hazards model|||1.07|0.81|0.320
71041637|NCT00809965|141592316|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.508|TWO_SIDED|95.0|0.83|1.1|||Log Rank||Based upon the Cox proportional hazards model|||1.10|0.83|0.508
71041638|NCT00809965|141592317|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.185|TWO_SIDED|95.0|0.8|1.04|||Log Rank||Based upon the Cox proportional hazards model|||1.04|0.80|0.185
71041639|NCT00809965|141592317|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.081|TWO_SIDED|95.0|0.78|1.01|||Log Rank||Based upon the Cox proportional hazards model|||1.01|0.78|0.081
71041640|NCT00809965|141592318|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.011|TWO_SIDED|95.0|0.73|0.96|||Log Rank||Based upon the Cox proportional hazards model|||0.96|0.73|0.011
71041641|NCT00809965|141592318|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.07|TWO_SIDED|95.0|0.78|1.01|||Log Rank||Based upon the Cox proportional hazards model|||1.01|0.78|0.070
70998662|NCT00004732|141504566|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.81|1.51|||||HR (95% CI) adjusted for age, sex and symptomatic status|||1.51|0.81|
70998663|NCT00004732|141504567|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.35|||||TWO_SIDED|95.0|0.82|2.23|||||HR (95% CI) for WOMEN CAS vs CEA (adjusted for age and symptomatic status)|||2.23|0.82|
70998664|NCT01183312|141504570|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||wilcoxon signed rank (paired)|||||||0.77
70998665|NCT01183312|141504571|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Wilcoxon Signed Rank (paired)|||||||0.51
70998666|NCT01183312|141504572|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Wilcoxon Signed Rank (paired)|||||||0.32
70998667|NCT01183312|141504573|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Wilcoxon Signed Rank (paired)|||||||0.56
70998668|NCT01183312|141504574|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Wilcoxon Signed Rank (paired)|||||||0.14
70998669|NCT01183312|141504575|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Wilcoxon Signed Rank (paired)|||||||0.89
70998670|NCT01183312|141504576|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||Wilcoxon Signed Rank (paired)|||||||0.13
70998671|NCT02713789|141504592|SUPERIORITY|||||||0.827|||||||ANCOVA|||SEP2||||0.827
70998672|NCT02713789|141504592|SUPERIORITY|||||||0.594|||||||ANCOVA|||SEP2||||0.594
70998673|NCT02713789|141504592|SUPERIORITY|||||||0.274|||||||ANCOVA|||SEP3||||0.274
70998674|NCT02713789|141504592|SUPERIORITY|||||||0.766|||||||ANCOVA|||SEP3||||0.766
70998675|NCT02713789|141504593|SUPERIORITY|||||||0.384|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.384
70998676|NCT02713789|141504593|SUPERIORITY|||||||0.144|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.144
70998677|NCT02713789|141504593|SUPERIORITY|||||||0.022|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.022
70998678|NCT02713789|141504593|SUPERIORITY|||||||0.137|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.137
70998679|NCT02713789|141504593|SUPERIORITY|||||||0.123|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.123
70998680|NCT02713789|141504594|SUPERIORITY|||||||0.16|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.160
70998681|NCT02713789|141504594|SUPERIORITY|||||||0.208|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.208
70998682|NCT02713789|141504594|SUPERIORITY|||||||0.316|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.316
70998683|NCT02713789|141504594|SUPERIORITY|||||||0.221|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.221
70998684|NCT02713789|141504594|SUPERIORITY|||||||0.172|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.172
70998685|NCT02713789|141504595|SUPERIORITY|||||||0.199|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.199
70998686|NCT02713789|141504595|SUPERIORITY|||||||0.203|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.203
70998687|NCT02713789|141504595|SUPERIORITY|||||||0.5|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.500
70998688|NCT02713789|141504595|SUPERIORITY|||||||0.296|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.296
70998689|NCT02713789|141504595|SUPERIORITY|||||||0.286|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.286
70998690|NCT02713789|141504596|SUPERIORITY|||||||0.449|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.449
70998691|NCT02713789|141504596|SUPERIORITY|||||||0.381|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.381
70998692|NCT02713789|141504596|SUPERIORITY|||||||0.011|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.011
70998693|NCT02713789|141504596|SUPERIORITY|||||||0.05|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.05
70998694|NCT02713789|141504596|SUPERIORITY|||||||0.09|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.09
70998695|NCT02713789|141504597|SUPERIORITY|||||||0.074|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.074
70998696|NCT02713789|141504597|SUPERIORITY|||||||0.468|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.468
70998697|NCT02713789|141504597|SUPERIORITY|||||||0.109|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.109
70998698|NCT02713789|141504597|SUPERIORITY|||||||0.493|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.493
70998699|NCT02713789|141504597|SUPERIORITY|||||||0.235|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.235
70998700|NCT02713789|141504598|SUPERIORITY|||||||0.136|||||||ANCOVA|||SEP1||||0.136
70998701|NCT02713789|141504598|SUPERIORITY|||||||0.498|||||||ANCOVA|||SEP1||||0.498
70998702|NCT02713789|141504598|SUPERIORITY|||||||0.369|||||||ANCOVA|||SEP4||||0.369
70998703|NCT02713789|141504598|SUPERIORITY|||||||0.337|||||||ANCOVA|||SEP4||||0.337
70998704|NCT02713789|141504598|SUPERIORITY|||||||0.16|||||||ANCOVA|||SEP5||||0.160
70998705|NCT03296787|141504621|SUPERIORITY|TAK-954 (Total): An analysis of variance (ANOVA) were performed on log transformed Cmax (total TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.7265|||||||ANOVA|||||||0.7265
70998706|NCT03296787|141504621|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed Cmax (total TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.9839|||||||ANOVA|||||||0.9839
70998707|NCT03296787|141504621|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of Cmax (free TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.9393|||||||ANOVA|||||||0.9393
70998708|NCT03296787|141504621|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of Cmax (free TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.1321|||||||ANOVA|||||||0.1321
70998709|NCT03296787|141504622|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed AUC(0-72) (total TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.36|||||||ANOVA|||||||0.3600
70998710|NCT03296787|141504622|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed AUC(0-72) (total TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.0816|||||||ANOVA|||||||0.0816
70998711|NCT03296787|141504622|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of AUC(0-72) (free TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.2686|||||||ANOVA|||||||0.2686
70998712|NCT03296787|141504622|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of AUC(0-72) (free TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.0059|||||||ANOVA|||||||0.0059
70998713|NCT03296787|141504623|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed AUClast (total TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.0998|||||||ANOVA|||||||0.0998
70998714|NCT03296787|141504623|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed AUClast (total TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.0155|||||||ANOVA|||||||0.0155
70998715|NCT03296787|141504623|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of AUClast (free TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.0916|||||||ANOVA|||||||0.0916
70998716|NCT03296787|141504623|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of AUClast (free TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.0014|||||||ANOVA|||||||0.0014
70998717|NCT03296787|141504624|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed AUC∞ (total TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.0038|||||||ANOVA|||||||0.0038
70998718|NCT03296787|141504624|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed AUC∞ (total TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.0004|||||||ANOVA|||||||0.0004
70998719|NCT03296787|141504624|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of AUC∞ (free TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.0389|||||||ANOVA|||||||0.0389
70998720|NCT03296787|141504624|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of AUC∞ (free TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.0011|||||||ANOVA|||||||0.0011
70998721|NCT01626989|141504636|NON_INFERIORITY_OR_EQUIVALENCE|Friedman Test comparing all 3 nights||||||0.001|||||||nonparametric Wilcoxon Signed Rank test|||||||.001
70998722|NCT02437487|141504650|SUPERIORITY||Relative Risk|1.2217|||||TWO_SIDED|95.0|0.7919|1.8849||||||||1.8849|0.7919|
70998723|NCT02437487|141504652|SUPERIORITY||Relative Risk|1.2624|||||TWO_SIDED|95.0|0.7668|2.0785||||||||2.0785|0.7668|
70998724|NCT02437487|141504653|SUPERIORITY||Relative Risk|1.2217|||||TWO_SIDED|95.0|0.7919|1.8849||||||||1.8849|0.7919|
70998725|NCT02437487|141504654|SUPERIORITY||Relative Risk|1.0878|||||TWO_SIDED|95.0|0.7383|1.6029||||||||1.6029|0.7383|
70998726|NCT01230749|141504667|SUPERIORITY_OR_OTHER||Difference in LSM|-27.4||||0.006|TWO_SIDED|95.0|-46.792|-8.008|||ANCOVA|||||-8.008|-46.792|0.006
70998727|NCT01230749|141504667|SUPERIORITY_OR_OTHER||Difference in LSM|-20.47||||0.038|TWO_SIDED|95.0|-39.801|-1.142|||ANCOVA|||||-1.142|-39.801|0.038
70998728|NCT01230749|141504667|SUPERIORITY_OR_OTHER||Difference in LSM|-13.24||||0.178|TWO_SIDED|95.0|-32.635|6.151|||ANCOVA|||||6.151|-32.635|0.178
70998729|NCT01230749|141504668|SUPERIORITY_OR_OTHER||Difference in LSM|-28.28||||0.005|TWO_SIDED|95.0|-47.606|-8.957|||ANCOVA|||||-8.957|-47.606|0.005
70998730|NCT01230749|141504668|SUPERIORITY_OR_OTHER||Difference in LSM|-21.97||||0.025|TWO_SIDED|95.0|-41.154|-2.786|||ANCOVA|||||-2.786|-41.154|0.025
70998731|NCT01230749|141504668|SUPERIORITY_OR_OTHER||Difference in LSM|-17.71||||0.069|TWO_SIDED|95.0|-36.86|1.431|||ANCOVA|||||1.431|-36.860|0.069
70998732|NCT01230749|141504669|SUPERIORITY_OR_OTHER||Difference in LSM|2.76||||0.628|TWO_SIDED|95.0|-8.542|14.054|||ANCOVA|||||14.054|-8.542|0.628
70998733|NCT01230749|141504669|SUPERIORITY_OR_OTHER||Difference in LSM|13.7||||0.018|TWO_SIDED|95.0|2.392|25.008|||ANCOVA|||||25.008|2.392|0.018
70998734|NCT01230749|141504669|SUPERIORITY_OR_OTHER||Difference in LSM|5.87||||0.303|TWO_SIDED|95.0|-5.417|17.148|||ANCOVA|||||17.148|-5.417|0.303
70998735|NCT01230749|141504670|SUPERIORITY_OR_OTHER||Difference in LSM|-1.86||||0.041|TWO_SIDED|95.0|-3.634|-0.082|||ANCOVA|||||-0.082|-3.634|0.041
70998736|NCT01230749|141504670|SUPERIORITY_OR_OTHER||Difference in LSM|-0.26||||0.769|TWO_SIDED|95.0|-2.033|1.509|||ANCOVA|||||1.509|-2.033|0.769
70998737|NCT01230749|141504670|SUPERIORITY_OR_OTHER||Difference in LSM|-0.69||||0.444|TWO_SIDED|95.0|-2.463|1.091|||ANCOVA|||||1.091|-2.463|0.444
70998738|NCT01230749|141504671|SUPERIORITY_OR_OTHER||GMR mulitplied by 100 percent|95.1||||0.774|TWO_SIDED|90.0|71.031|127.324|||ANCOVA|||||127.324|71.031|0.774
70998739|NCT01230749|141504671|SUPERIORITY_OR_OTHER||GMR multiplied by 100 percent|89.9||||0.555|TWO_SIDED|90.0|66.567|121.403|||ANCOVA|||||121.403|66.567|0.555
70998740|NCT01230749|141504672|SUPERIORITY_OR_OTHER||GMR multiplied by 100 percent|100.17||||0.968|TWO_SIDED|90.0|93.217|107.647|||ANCOVA|||||107.647|93.217|0.968
70998741|NCT01230749|141504672|SUPERIORITY_OR_OTHER||GMR multiplied by 100 percent|101.18||||0.785|TWO_SIDED|90.0|94.179|108.7|||ANCOVA|||||108.700|94.179|0.785
70998742|NCT01230749|141504673|SUPERIORITY_OR_OTHER||GMR multiplied by 100 percent|133.27||||0.097|TWO_SIDED|90.0|100.275|177.115|||ANCOVA|||||177.115|100.275|0.097
70998743|NCT01230749|141504673|SUPERIORITY_OR_OTHER||GMR mulitplied by 100 percent|101.82||||0.917|TWO_SIDED|90.0|76.26|135.942|||ANCOVA|||||135.942|76.260|0.917
70998744|NCT01230749|141504674|SUPERIORITY_OR_OTHER||Difference in LSM|0.46||||0.295|TWO_SIDED|95.0|-0.408|1.323|||ANCOVA|||||1.323|-0.408|0.295
70998745|NCT01230749|141504674|SUPERIORITY_OR_OTHER||Difference in LSM|0.03||||0.941|TWO_SIDED|95.0|-0.838|0.904|||ANCOVA|||||0.904|-0.838|0.941
70998746|NCT01230749|141504674|SUPERIORITY_OR_OTHER||Difference in LSM|1.02||||0.022|TWO_SIDED|95.0|0.15|1.892|||ANCOVA|||||1.892|0.150|0.022
70998747|NCT01060098|141504675|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||week 0 compared to week 12||||0.003
70998748|NCT01060098|141504675|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||week 0 compared to week 12||||0.04
70998749|NCT01060098|141504675|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||week 0 compared to week 12||||0.48
70998750|NCT01432457|141504731|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.57||||0.006|TWO_SIDED|95.0|0.44|2.69||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|Mixed Models Analysis|||A mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline HAM-D17 score as a covariate was used to compare DVS SR dose to placebo. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||2.69|0.44|0.006
70998751|NCT01432457|141504731|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.96|||<|0.001|TWO_SIDED|95.0|0.84|3.08||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|Mixed Models Analysis|||A mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline HAM-D17 score as a covariate was used to compare DVS SR dose to placebo. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||3.08|0.84|< 0.001
70998752|NCT01432457|141504732|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.36||||0.014|TWO_SIDED|95.0|0.28|2.45|||ANCOVA|||To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||2.45|0.28|0.014
70998753|NCT01432457|141504732|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.67||||0.002|TWO_SIDED|95.0|0.59|2.74|||ANCOVA|||To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||2.74|0.59|0.002
70998754|NCT01432457|141504733|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED|||||"p-value was obtained from the separate pair-wise Cochran-Mantel-Haenszel test versus placebo for the alternative hypothesis of Row Mean Scores Differences controlling for site."|Cochran-Mantel-Haenszel|||CGI-I was analyzed with the Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores. Each DVS SR arm was separately compared to placebo controlling for site. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||||0.029
70998755|NCT01432457|141504733|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||"p-value was obtained from the separate pair-wise Cochran-Mantel-Haenszel test versus placebo for the alternative hypothesis of Row Mean Scores Differences controlling for site."|Cochran-Mantel-Haenszel|||CGI-I was analyzed with the Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores. Each DVS SR arm was separately compared to placebo controlling for site. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||||< 0.001
70998756|NCT01432457|141504734|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.2||||0.009|TWO_SIDED|95.0|0.05|0.34|||Mixed Models Analysis|||CGI-S was analyzed using the mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline CGI-S score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||0.34|0.05|0.009
70998757|NCT01432457|141504734|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.28|||<|0.001|TWO_SIDED|95.0|0.13|0.43|||Mixed Models Analysis|||CGI-S was analyzed using the mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline CGI-S score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||0.43|0.13|< 0.001
70998758|NCT01432457|141504735|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.17||||0.062|TWO_SIDED|95.0|-0.01|0.34|||ANCOVA|||To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||0.34|-0.01|0.062
70998759|NCT01432457|141504735|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.22||||0.014|TWO_SIDED|95.0|0.04|0.39|||ANCOVA|||To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||0.39|0.04|0.014
70998760|NCT01432457|141504736|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.242||||0.198|TWO_SIDED|95.0|0.893|1.726|||Regression, Logistic|||Response in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||1.726|0.893|0.198
70998761|NCT01432457|141504736|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.378||||0.054|TWO_SIDED|95.0|0.995|1.91|||Regression, Logistic|||Response in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||1.910|0.995|0.054
70998762|NCT01432457|141504737|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.105||||0.615|TWO_SIDED|95.0|0.749|1.631|||Regression, Logistic|||Remission in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||1.631|0.749|0.615
70998763|NCT01432457|141504737|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.412||||0.072|TWO_SIDED|95.0|0.969|2.057|||Regression, Logistic|||Remission in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||2.057|0.969|0.072
71041642|NCT00112294|141592370|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.902||||0.2358|TWO_SIDED|95.0|0.761|1.069||Since only 1 primary comparison was conducted, no adjustment for multiple comparisons was needed.|Log Rank||The hazard ratio of C/T/C to T/C was estimated by means of a stratified Cox's proportional hazard model, with treatment as the single covariate.|Confidence intervals calculated using Brookmeyer and Crowley method. Primary analysis was comparison of PFS between arms performed by 2-sided alpha=0.05 level, log-rank test, stratified by ECOG PS (0/1) and intended on-study taxane (docetaxel or paclitaxel). Null hypothesis was that PFS was equal in both groups. Power calculations indicated that \>=510 events (IRRC progressions/deaths) would lead to \>=90% power at the 5% level for rejecting the null hypothesis, given a true hazard ratio of 0.75.||1.069|0.761|0.2358
70998764|NCT01432457|141504738|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.09||||0.837|TWO_SIDED|95.0|-0.98|0.8||p-value was obtained from the ANCOVA model as change from baseline = Treatment + Site + Gender + Baseline|ANCOVA|||The treatment by gender interaction was first tested using an analysis of covariance (ANCOVA) model with treatment, site, gender, and treatment by gender as factors and the baseline total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||0.80|-0.98|0.837
71041643|NCT00112294|141592371|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.675||||0.0066|TWO_SIDED|95.0|1.152|2.436|||Cochran-Mantel-Haenszel||The odds ratio is presented for C/T/C to T/C.|The 2 groups were compared by means of a Cochran-Mantel-Haenszel (CMH) (alpha = 0.05 level) test stratified by ECOG PS (0 or 1) and intended on-study taxane (paclitaxel, docetaxel), as recorded at the time of randomization.||2.436|1.152|0.0066
70998765|NCT01432457|141504738|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.32||||0.471|TWO_SIDED|95.0|-1.19|0.55||p-value was obtained from the ANCOVA model as change from baseline = Treatment + Site + Gender + Baseline|ANCOVA|||The treatment by gender interaction was first tested using an analysis of covariance (ANCOVA) model with treatment, site, gender, and treatment by gender as factors and the baseline total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||0.55|-1.19|0.471
70998766|NCT00247273|141504759|NON_INFERIORITY_OR_EQUIVALENCE|In order to establish noninferiority for the primary efficacy variable at one-sided α of 2.5% with 90% power, a total of 1068 patients, 534 per treatment group, is required. This calculation is based on the following assumptions: the noninferiority margin (or delta) = 1.5%, the common SD (standard deviation) of the percent change from baseline in lumbar spine BMD at Month 12 = 4.5%, the 1 year dropout rate = 20%, and the true mean difference μD - μM = 0.5%.|Least Square (LS) Mean Difference|-0.115|||||TWO_SIDED|95.0|-0.505|0.274|||ANOVA|Fixed effects for treatment and pooled center||||0.274|-0.505|
70998767|NCT00247273|141504760|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.076|||||TWO_SIDED|95.0|-0.475|0.323|||ANOVA|Fixed effects for treatment and pooled center.||||0.323|-0.475|
70998768|NCT00247273|141504761|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0005|||||TWO_SIDED|95.0|-0.0035|0.0024|||ANOVA|Fixed effects for treatment and pooled center.||||0.0024|-0.0035|
70998769|NCT00247273|141504762|NON_INFERIORITY_OR_EQUIVALENCE|The estimates of the common SD, dropout rate at month 24 and true difference are also based on previous risedronate Phase III studies (RVN008993, RVE009093, ROE009394, HMR4003E/3001).|LS Mean Difference|-0.239|||||TWO_SIDED|95.0|-0.727|0.249|||ANOVA|Fixed effects for treatment and pooled centers.||The sample size of 1068 patients will provide approximately 90% power to demonstrate the noninferiority of the monthly regimen at month 24, using a 2% noninferiority margin and assuming a common SD of the percent change from baseline in lumbar spine BMD at month 24 of 5%, a 2-year dropout rate of 30%, and a true mean difference (uDaily-uMonthly) of 0.8%.||0.249|-0.727|
70998770|NCT00247273|141504763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.085|||||TWO_SIDED|95.0|-0.609|0.439|||ANOVA|Fixed Effects for treatment \& pooled center||||0.439|-0.609|
70998771|NCT00247273|141504764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0009|||||TWO_SIDED|95.0|-0.0048|0.0029|||ANOVA|Fixed effects for treatment and pooled center.||||0.0029|-0.0048|
70998772|NCT00247273|141504765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||||TWO_SIDED|95.0|-2.83|3.28|||ANOVA|Fixed effects for treatment and pooled center.||||3.28|-2.83|
70998773|NCT00247273|141504766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.57|||||TWO_SIDED|95.0|-4.47|1.33|||ANOVA|Fixed effects for treatment and pooled center||||1.33|-4.47|
71041644|NCT00112294|141592372|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.265||||0.1501|TWO_SIDED|95.0|0.918|1.741|||Cochran-Mantel-Haenszel||The odds ratio is presented for C/T/C to T/C.|The 2 groups were compared by means of a CMH (alpha = 0.05 level) test stratified by ECOG PS (0 or 1) and intended on-study taxane (paclitaxel, docetaxel), as recorded at the time of randomization.||1.741|0.918|0.1501
71102640|NCT01979185|141713917|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% CI of the geometric mean ratios fell within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|0.594|||||TWO_SIDED|90.0|0.526|0.672|||Mixed-effects Model|||The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects, and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in pharmacokinetic parameters, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.||0.672|0.526|
70998774|NCT00247273|141504767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.54|4.53|||ANOVA|Fixed effects for treatment and pooled center||||4.53|-2.54|
70998775|NCT00247273|141504768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.83|||||TWO_SIDED|95.0|-6.45|0.8|||ANOVA|Fixed effects for treatment and pooled center.||||0.80|-6.45|
70998776|NCT00247273|141504769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.05|0.0|||ANOVA|Fixed effects for treatment and pooled center||||0.00|-0.05|
70998777|NCT00247273|141504770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.17|||||TWO_SIDED|95.0|-7.98|-0.36|||ANOVA|Fixed effects for treatment and pooled center||||-0.36|-7.98|
70998778|NCT00247273|141504771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.06|0.01|||ANOVA|Fixed effects for treatment and pooled center||||0.01|-0.06|
70998779|NCT00247273|141504772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.69|||||TWO_SIDED|95.0|-12.04|0.66|||ANOVA|Fixed effects for treatment and pooled center||||0.66|-12.04|
70998780|NCT00247273|141504773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-0.29|0.64|||ANOVA|Fixed effects for treatment and pooled center||||0.64|-0.29|
70998781|NCT00247273|141504774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.31|||||TWO_SIDED|95.0|-0.85|3.48|||ANOVA|Fixed effects for treatment and pooled center||||3.48|-0.85|
70998782|NCT00247273|141504775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.45|0.7|||ANOVA|Fixed effects for treatment and pooled center||||0.70|-0.45|
71041645|NCT00112294|141592375|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.1685|TWO_SIDED|95.0|0.754|1.051||An interim analysis on survival was performed. Final p-value was adjusted using an alpha spending function. At the interim analysis (data not reported here) the type 1 error was 0.0001, and the rest is for the final look.|Log Rank||The hazard ratio of C/T/C to T/C was estimated by means of a stratified Cox's proportional hazard model with treatment as the single covariate.|Confidence intervals were calculated using Brookmeyer and Crowley method. Analysis was a comparison of survival between groups by means of a 2-sided, alpha=0.05 level, log-rank test, stratified by ECOG PS (0/1) and intended on-study taxane (docetaxel or paclitaxel). Null hypothesis was that survival was equal in both treatment arms. Power calculations indicated that \>= 558 events would lead to at \>=75% power at the 5% level for rejecting the null hypothesis, given a true hazard ratio of 0.8.||1.051|0.754|0.1685
71041646|NCT00112294|141592376|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Cochran-Mantel-Haenszel|||Improvement of symptoms was compared between groups by means of a CMH (alpha = 0.05 level) test stratified by ECOG PS (0 or 1) and intended on-study taxane (paclitaxel, docetaxel), as recorded at the time of randomization.||||0.26
71041647|NCT01142908|141592389|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1||||0.93|TWO_SIDED|95.0|-2.8|3.1|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||3.1|-2.8|0.93
71100339|NCT02496156|141709310|SUPERIORITY||||||>|0.05||||||This is a computed p-value.|Mixed Models Analysis|||See description of analysis below.|For each outcome, a linear mixed effects model was fit; with the exception of the Knowledge test where a linear model was fit. Separate models were fit for Parents and adolescents except for HbA1C. The predictor variable is treatment group (SMDM vs. UCP). Covariates are gender, age, social economic status, and family structure as determined by (number of siblings and of caregivers in the home). A random intercept was fit for each subject across the longitudinal data. To accommodate missing values multiple imputation methodology was applied to the data, resulting in five imputed datasets. For each imputed dataset, a linear mixed effects model (or linear model for Knowledge Test) was fit; the resulting five models were pooled into a final model and summary statistics are presented. A two-sided Wald's t test determined significance of covariates. The significance level was 0.05. Appropriate model diagnostics were performed to assess model fit.|||>0.05
71100340|NCT02496156|141709311|SUPERIORITY||||||>|0.05||||||Computed p-value|ANCOVA|Difference in post-test scores with baseline Knowledge test score as the covariate.||||||>0.05
71100341|NCT02496156|141709313|SUPERIORITY|See analysis description below.|||||>|0.05||||||Computed p-value|ANOVA||||For each outcome, a linear mixed effects model was fit; with the exception of the Knowledge test where a linear model was fit. Separate models were fit for Parents and adolescents except for HbA1C. The predictor variable is treatment group (SMDM vs. UCP). Covariates are gender, age, social economic status, and family structure as determined by (number of siblings and of caregivers in the home). A random intercept was fit for each subject across the longitudinal data. To accommodate missing values multiple imputation methodology was applied to the data, resulting in five imputed datasets. For each imputed dataset, a linear mixed effects model (or linear model for Knowledge Test) was fit; the resulting five models were pooled into a final model and summary statistics are presented. A two-sided Wald's t test determined significance of covariates. The significance level was 0.05. Appropriate model diagnostics were performed to assess model fit.|||>0.05
71100342|NCT04349098|141709324|SUPERIORITY||Odds Ratio (OR)|0.84||||0.675|TWO_SIDED|95.0|0.39|1.79|||Cochran-Mantel-Haenszel|||||1.79|0.39|0.6750
70998783|NCT00247273|141504776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|||||TWO_SIDED|95.0|-3.96|2.43|||ANOVA|Fixed effects for treatment and pooled center||||2.43|-3.96|
70998784|NCT00247273|141504777|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96||||1|TWO_SIDED|95.0|0.36|2.54|||Fisher Exact|||||2.54|0.36|1.0000
71041648|NCT01142908|141592390|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.4||||0.34|TWO_SIDED|95.0|-1.5|4.3|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months.||4.3|-1.5|0.34
71041649|NCT01142908|141592392|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.91|TWO_SIDED|95.0|-2.0|1.8|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||1.8|-2.0|0.91
71041650|NCT01142908|141592393|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.4||||0.7|TWO_SIDED|95.0|-1.5|2.2|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months.||2.2|-1.5|0.70
71041651|NCT01142908|141592394|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.8||||0.1|TWO_SIDED|95.0|-3.9|0.3|||Mixed Models Analysis||Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||0.3|-3.9|0.1
71041652|NCT01142908|141592395|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.3||||0.74|TWO_SIDED|95.0|-2.4|1.7|||Mixed Models Analysis||Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months||1.7|-2.4|0.74
71041653|NCT01142908|141592397|SUPERIORITY_OR_OTHER_LEGACY||logit-difference (Net)|-0.03||||0.87|TWO_SIDED|95.0|-0.4|0.3|||Gen. Est. Equation with a Logit Link|Method Used Expanded: Generalized Estimating Equation with a Logit Link. Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||0.3|-0.4|0.87
70998785|NCT00247273|141504778|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98||||1|TWO_SIDED|95.0|0.47|2.03|||Fisher Exact|||||2.03|0.47|1.0000
70998786|NCT00607919|141504809|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
70998787|NCT02007252|141504878|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.1037|||||||ANCOVA|||Month 3||||= 0.1037
70998788|NCT02007252|141504878|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.4806|||||||ANCOVA|||Month 12||||= 0.4806
71041654|NCT01142908|141592398|SUPERIORITY_OR_OTHER_LEGACY||logit-difference (Net)|0.2||||0.36|TWO_SIDED|95.0|-0.2|0.5|||Gen. Est. Equation with a Logit Link|Method Used Expanded: Generalized Estimating Equation with a Logit Link. Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months.||0.5|-0.2|0.36
71041655|NCT01142908|141592400|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.9||||0.08|TWO_SIDED|95.0|-10.3|0.6|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||0.6|-10.3|0.08
71041656|NCT01142908|141592401|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.8||||0.79|TWO_SIDED|95.0|-6.6|5.0|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months.||5.0|-6.6|0.79
71041657|NCT01142908|141592403|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.02||||0.83|TWO_SIDED|95.0|-0.2|0.2|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||0.2|-0.2|0.83
71041658|NCT01142908|141592404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.54|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months.||0.2|-0.4|0.54
70998789|NCT00150345|141504907|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.493||||0.258|TWO_SIDED|95.0|0.129|1.755|||Regression, Logistic||Odds ratio computed from the logistic regression (logit model) including terms for treatment arm, concomitant fluconazole, and positive PCR before randomization. Event IFI=yes is modeled.|Hypothesis: H0: rv - rp = 0 vs H1: rv - rp does not equal 0, where ri is rate of IFI (i=v for voriconazole group, i=p for deferred voriconazole group). Logit model (including important covariates) used. The adjusted odds ratio and 95 percent (%) confidence interval (CI) for adjusted odds ratio calculated. If 95% CI around odds ratio does not contain a value of 1, then the null hypothesis of equal rates of IFI between immediate voriconazole and deferred voriconazole to be rejected.||1.755|0.129|0.258
70998790|NCT00150345|141504908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.822||||0.596|TWO_SIDED|95.0|0.398|1.696|||Regression, Logistic||Odds ratio computed from the logistic regression (logit model) including terms for treatment arm, concomitant fluconazole, and positive PCR before randomization. Event defervescence=yes is modeled.|||1.696|0.398|0.596
70998791|NCT00150345|141504909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.936||||0.864|TWO_SIDED|95.0|0.441|1.988|||Regression, Logistic||Odds ratio computed from the logistic regression (logit model) including terms for treatment arm, concomitant fluconazole, and positive PCR before randomization. Event defervescence=yes is modeled.|||1.988|0.441|0.864
71041659|NCT01142908|141592406|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.2||||0.29|TWO_SIDED|95.0|-0.6|0.2|||Mixed Models Analysis|Adjusted for gender and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||0.2|-0.6|0.29
71041660|NCT01142908|141592407|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.72|TWO_SIDED|95.0|-0.5|0.4|||Mixed Models Analysis|Adjusted for gender and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months||0.4|-0.5|0.72
71041661|NCT01186016|141592422|OTHER||||||<|0.01||||||A priori threshold for the P-Value was.05 or less.|ANOVA|||The scores on the Genetic Knowledge Test for both groups between baseline and the end of the educational sessions were analyzed with repeated measures ANOVA.||||<0.01
71041662|NCT01186016|141592423|OTHER|||||||0.44||||||The a priori threshold for statistical significance was a P-Value of .05 or less.|ANOVA|||Data for Self-Efficacy for Quitting/Resisting Smoking were analyzed with repeated measures ANOVA using three time points: baseline, end of the educational sessions, and end of the smoking cessation sessions.||||0.44
71041663|NCT01186016|141592424|OTHER|Nominal data were analyzed with Chi Square.||||||0.88||||||The a priori threshold P-Value for statistical significance was .05 or less.|Chi-squared|||||||.88
71041664|NCT01362296|141592470|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.5197|TWO_SIDED|95.0|0.75|1.75||P-value from the stratified log-rank was adjusted for gender (male versus female).|Log Rank||HRs were estimated using a Pike estimator. The HR from the stratified log-rank test was adjusted for gender (male versus female).|||1.75|0.75|0.5197
71100343|NCT01703221|141709337|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|-0.8|||<|0.001|TWO_SIDED|95.0|-0.96|-0.63|||Constrained longitudinal analysis|Terms for treatment, prior oral antihyperglycemic agent (AHA), time, time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||-0.63|-0.96|<0.001
70998792|NCT00150345|141504910|SUPERIORITY_OR_OTHER|||||||0.955|TWO_SIDED||||||Log Rank|||||||0.955
70998793|NCT00150345|141504912|SUPERIORITY_OR_OTHER||Difference in % participants that died|5.85|||||TWO_SIDED|95.0|-5.08|16.78|||||Approximate 2-sided confidence interval (CI).|Difference in proportions expressed as a percent: immediate voriconazole versus (vs) deferred voriconazole treatment||16.78|-5.08|
70998794|NCT00150345|141504913|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Log Rank|||||||0.190
71041665|NCT00653159|141592491|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4003|||||||Fisher Exact|Two-sided test||Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject completed the final study visit at 6 months. Under the null hypothesis, study completion rates are similar for both IUD types.||||0.4003
71041666|NCT00653159|141592492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4136|||||||Fisher Exact|Two-sided test||Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject experienced heavy bleeding. Under the null hypothesis, heavy bleeding rates are similar for both IUD types.||||0.4136
71041667|NCT00653159|141592493|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4783|||||||Fisher Exact|Two-sided test||Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject became pregnant within 6 months of IUD insertion. Under the null hypothesis, pregnancy rates are similar for both IUD types.||||0.4783
71100344|NCT01703221|141709337|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|-0.78|||<|0.001|TWO_SIDED|95.0|-0.94|-0.61|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||-0.61|-0.94|<0.001
71041668|NCT00653159|141592494|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2174|||||||Fisher Exact|Two-sided test||Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject experienced expulsion of the IUD. Under the null hypothesis, expulsion rates are similar for both IUD types.||||0.2174
71041669|NCT00653159|141592495|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|Two-sided test||"Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject reported being satisfied (happy or very happy) at the 6 month study visit. Under the null hypothesis, satisfaction rates are similar for both IUD types."||||1.0000
70998795|NCT00150345|141504914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.031|STANDARD_ERROR_OF_MEAN|10.888||0.049|TWO_SIDED|95.0|-44.004|-0.059||SAS PROC REG with SELECTION=STEPWISE option of SLENTRY=0.05 and SLSTAY=0.10 utilized. Stepwise option combined forward stepping (with a 0.05 level to enter) with elimination of variables already in model that do not stay significant at 0.10 level.|Regression, Linear|Variables: association with age, c-reactive protein, and time to continuous defervescence not significant at 0.05 level; not included in final model||Continuous defervescence achieved=Yes||-0.059|-44.004|0.049
70998796|NCT00150345|141504934|SUPERIORITY_OR_OTHER||Difference in percentages|2.51|||||TWO_SIDED|95.0|-14.96|19.97||||||Difference in proportions expressed as a percent: immediate voriconazole vs deferred voriconazole treatment||19.97|-14.96|
71041670|NCT00109837|141592496|SUPERIORITY_OR_OTHER||Proportion in 1-year CCR|0.36|STANDARD_DEVIATION|0.06|||ONE_SIDED|95.0|0.25|||||||The regimen would be of no further interest if the true 1-year continuous complete remission (CCR) rate was less than 45% (null). Sample size was chosen for an alternative of 65%, power of 92% and type-1 error of 4.6%.|||0.25|
71041671|NCT00381849|141592498|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of CaOx between baseline and after 6 weeks' treatment on placebo.||||0.32
71041672|NCT00381849|141592498|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of CaOx between baseline and after 6 weeks' treatment on cystone.||||0.23
71041673|NCT00381849|141592498|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of CaOx between six weeks' treatment on cystone and 6 weeks' treatment on placebo.||||0.41
71100345|NCT01703221|141709337|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Omarigliptin will be considered non-inferior to sitagliptin if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in least squares means for change from baseline in HbA1c at Week 24 (omarigliptin minus sitagliptin) is not more than 0.3% (non-inferiority margin).|Difference in the least squares means|-0.02||||0.792|TWO_SIDED|95.0|-0.15|0.12|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||0.12|-0.15|0.792
71100346|NCT01703221|141709342|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|-36.89|||<|0.001|TWO_SIDED|95.0|-48.46|-25.33|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||-25.33|-48.46|<0.001
71100347|NCT01703221|141709342|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|-39.76|||<|0.001|TWO_SIDED|95.0|-51.28|-28.23|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||-28.23|-51.28|<0.001
71041674|NCT00381849|141592498|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of CaOx between baseline and after 46 weeks' treatment on cystone.||||0.32
71041675|NCT00381849|141592499|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of Brushite between baseline and after 6 weeks' treatment on placebo.||||0.49
71041676|NCT00381849|141592499|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of Brushite between baseline and after 6 weeks' treatment on cystone.||||0.64
71041677|NCT00381849|141592499|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of Brushite between six weeks' treatment on cystone and 6 weeks' treatment on placebo.||||0.72
71041678|NCT00381849|141592499|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of Brushite between baseline and after 46 weeks' treatment on cystone.||||0.84
71041679|NCT00381849|141592502|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||t-test, 1 sided|||Paired t test for urinary cystine between baseline and after 6 weeks' treatment on placebo.||||0.69
71041680|NCT00381849|141592502|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||t-test, 1 sided|||Paired t test for urinary cystine between baseline and after 6 weeks' treatment on cystone.||||0.25
71041681|NCT00381849|141592502|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||t-test, 1 sided|||Paired t test for urinary cystine between six weeks' treatment on cystone and 6 weeks' treatment on placebo.||||0.15
71041682|NCT00381849|141592502|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||t-test, 1 sided|||Paired t test for urinary cystine between baseline and after 46 weeks' treatment on cystone.||||0.20
71041683|NCT00381849|141592503|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||t-test, 2 sided|||Right Kidney Stone Density; P-value comparing one year to baseline||||0.85
71041684|NCT00381849|141592503|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||t-test, 2 sided|||Left Kidney Stone Density; P-value comparing one year to baseline||||0.63
71041685|NCT00381849|141592503|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||t-test, 2 sided|||Right Kidney Stone Density; P-value comparing one year to baseline||||0.97
71041686|NCT00381849|141592503|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||t-test, 2 sided|||Left Kidney Stone Density; P-value comparing one year to baseline||||0.15
71041687|NCT00381849|141592504|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||t-test, 2 sided|||Right Kidney Stone Volume; P-value comparing one year to baseline||||0.81
71041688|NCT00381849|141592504|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||t-test, 2 sided|||Left Kidney Stone Volume; P-value comparing one year to baseline||||0.78
71041689|NCT00381849|141592504|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||t-test, 2 sided|||Right Kidney Stone Volume; P-value comparing one year to baseline||||0.96
71041690|NCT00381849|141592504|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||t-test, 2 sided|||Left Kidney Stone Volume; P-value comparing one year to baseline||||0.13
70998797|NCT01457924|141504941|SUPERIORITY_OR_OTHER||Ratio|0.35|||<|0.001|TWO_SIDED|95.0|0.221|0.548|||Non-Linear Emax Model|||Note: There is a discrepancy in the number of par. in ITT populations at Wk 24 and Wk 48: 228 and 229 respectively. This resulted from a data issue: one par was incorrectly excluded from ITT pop. at Wk 24, but correctly included in Wk 48. This error affects all source tables, analyses relating to ITT and per protocol populations, primary endpoint and secondary MRI endpoints reported at Wk 24. This discrepancy affects all statistical analyses, but not summary statistics.||0.548|0.221|<0.001
70998798|NCT01457924|141504941|SUPERIORITY_OR_OTHER||Ratio|0.35|||<|0.001|TWO_SIDED|95.0|0.221|0.548|||Non-Linear Emax Model|||||0.548|0.221|<0.001
71100348|NCT01703221|141709342|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|2.86||||0.555|TWO_SIDED|95.0|-6.67|12.39|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||12.39|-6.67|0.555
71100349|NCT01703221|141709343|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|-12.28|||<|0.001|TWO_SIDED|95.0|-17.78|-6.78|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||-6.78|-17.78|<0.001
71100350|NCT01703221|141709343|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|-14.51|||<|0.001|TWO_SIDED|95.0|-20.04|-8.98|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||-8.98|-20.04|<0.001
71100351|NCT01703221|141709343|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|2.23||||0.33|TWO_SIDED|95.0|-2.27|6.73|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||6.73|-2.27|0.330
70998799|NCT01457924|141504941|SUPERIORITY_OR_OTHER||Ratio|0.35|||<|0.001|TWO_SIDED|95.0|0.221|0.548|||Non-Linear Emax Model|||||0.548|0.221|<0.001
70998800|NCT01457924|141504941|SUPERIORITY_OR_OTHER||Ratio|0.35|||<|0.001|TWO_SIDED|95.0|0.221|0.548|||Non-Linear Emax Model|||||0.548|0.221|<0.001
71100352|NCT05486065|141709344|SUPERIORITY|The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.|Treatment difference|-0.82||||0.0002|TWO_SIDED|95.0|-1.25|-0.39|||ANCOVA|||||-0.39|-1.25|0.0002
71100353|NCT05486065|141709344|SUPERIORITY|The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.|Treatment difference|-0.77||||0.0003|TWO_SIDED|95.0|-1.19|-0.35|||ANCOVA|||||-0.35|-1.19|0.0003
71100354|NCT05486065|141709344|SUPERIORITY|The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.|Treatment difference|-1.07|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.64|||ANCOVA|||||-0.64|-1.50|<.0001
71100355|NCT05486065|141709344|OTHER||Treatment difference|0.05||||0.8305|TWO_SIDED|95.0|-0.38|0.47|||ANCOVA|||The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.||0.47|-0.38|0.8305
70998801|NCT01457924|141504942|SUPERIORITY_OR_OTHER||Ratio|0.38||||0.003|TWO_SIDED|95.0|0.2|0.72|||Generalized Linear Model|||||0.72|0.20|0.003
70998802|NCT01457924|141504942|SUPERIORITY_OR_OTHER||Ratio|0.38||||0.003|TWO_SIDED|95.0|0.2|0.72|||Generalized Linear Model|||||0.72|0.20|0.003
70998803|NCT01457924|141504942|SUPERIORITY_OR_OTHER||Ratio|0.35||||0.001|TWO_SIDED|95.0|0.19|0.65|||Generalized Linear Model|||||0.65|0.19|0.001
70998804|NCT01457924|141504942|SUPERIORITY_OR_OTHER||Ratio|0.23|||<|0.001|TWO_SIDED|95.0|0.13|0.39|||Generalized Linear Model|||||0.39|0.13|<0.001
70998805|NCT01457924|141504945|SUPERIORITY_OR_OTHER||Ratio|0.31|||<|0.001|TWO_SIDED|95.0|0.16|0.6|||Generalized Linear Model|||||0.60|0.16|<0.001
70998806|NCT01457924|141504945|SUPERIORITY_OR_OTHER||Ratio|0.56||||0.075|TWO_SIDED|95.0|0.29|1.06|||Generalized Linear Model|||||1.06|0.29|0.075
70998807|NCT01457924|141504945|SUPERIORITY_OR_OTHER||Ratio|0.51||||0.035|TWO_SIDED|95.0|0.27|0.95|||Generalized Linear Model|||||0.95|0.27|0.035
70998808|NCT01457924|141504945|SUPERIORITY_OR_OTHER||Ratio|0.32|||<|0.001|TWO_SIDED|95.0|0.19|0.55|||Generalized Linear Model|||||0.55|0.19|<0.001
70998809|NCT01457924|141504946|SUPERIORITY_OR_OTHER||Ratio|0.22||||0.026|TWO_SIDED|95.0|0.06|0.84|||Generalized Linear Model|||||0.84|0.06|0.026
70998810|NCT01457924|141504946|SUPERIORITY_OR_OTHER||Ratio|0.49||||0.296|TWO_SIDED|95.0|0.13|1.86|||Generalized Linear Model|||||1.86|0.13|0.296
70998811|NCT01457924|141504946|SUPERIORITY_OR_OTHER||Ratio|0.5||||0.285|TWO_SIDED|95.0|0.14|1.78|||Generalized Linear Model|||||1.78|0.14|0.285
70998812|NCT01457924|141504946|SUPERIORITY_OR_OTHER||Ratio|0.25||||0.009|TWO_SIDED|95.0|0.09|0.71|||Non-Linear Emax Model|||||0.71|0.09|0.009
70998813|NCT01457924|141504947|SUPERIORITY_OR_OTHER||Ratio|0.18||||0.004|TWO_SIDED|95.0|0.05|0.58|||Generalized Linear Model|||||0.58|0.05|0.004
70998814|NCT01457924|141504947|SUPERIORITY_OR_OTHER||Ratio|0.5||||0.248|TWO_SIDED|95.0|0.15|1.63|||Generalized Linear Model|||||1.63|0.15|0.248
70998815|NCT01457924|141504947|SUPERIORITY_OR_OTHER||Ratio|0.46||||0.181|TWO_SIDED|95.0|0.15|1.43|||Generalized Linear Model|||||1.43|0.15|0.181
70998816|NCT01457924|141504947|SUPERIORITY_OR_OTHER||Ratio|0.24||||0.003|TWO_SIDED|95.0|0.1|0.62|||Generalized Linear Model|||||0.62|0.10|0.003
70998817|NCT01457924|141504948|SUPERIORITY_OR_OTHER||Ratio|0.29|||<|0.001|TWO_SIDED|95.0|0.15|0.58|||Generalized Linear Model|||||0.58|0.15|<0.001
70998818|NCT01457924|141504948|SUPERIORITY_OR_OTHER||Ratio|0.34||||0.002|TWO_SIDED|95.0|0.17|0.68|||Generalized Linear Model|||||0.68|0.17|0.002
70998819|NCT01457924|141504948|SUPERIORITY_OR_OTHER||Ratio|0.4||||0.006|TWO_SIDED|95.0|0.21|0.77|||Generalized Linear Model|||||0.77|0.21|0.006
70998820|NCT01457924|141504948|SUPERIORITY_OR_OTHER||Ratio|0.19|||<|0.001|TWO_SIDED|95.0|0.11|0.35|||Generalized Linear Model|||||0.35|0.11|<0.001
70998821|NCT02001688|141504952|SUPERIORITY|||||||0.0005||||||One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance|Wilcoxon (Mann-Whitney)|||||||0.0005
70998822|NCT02001688|141504952|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance||||||0.020
70998823|NCT02001688|141504952|SUPERIORITY|||||||0.0192|||||||Wilcoxon (Mann-Whitney)|One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance||||||0.0192
70998824|NCT02001688|141504953|SUPERIORITY|||||||0.0005||||||One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance|Wilcoxon (Mann-Whitney)|p-value of Stratified Wilcoxon test||||||0.0005
70998825|NCT02001688|141504953|SUPERIORITY|||||||0.0193|||||||Wilcoxon (Mann-Whitney)|One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance||||||0.0193
70998826|NCT02001688|141504953|SUPERIORITY|||||||0.2485|||||||Wilcoxon (Mann-Whitney)|One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance||||||0.2485
70998827|NCT02001688|141504954|SUPERIORITY||||||<|0.0001|||||||Kruskal-Wallis|p-value of Kruskal-Wallis test (3 groups: Kamada-AAT for Inhalation, 80mg,Kamada-AAT for Inhalation, 160mg and placebo)||||||<0.0001
70998828|NCT02001688|141504955|SUPERIORITY||||||<|0.0001|||||||Kruskal-Wallis|p-value of Kruskal-Wallis test (3 groups: Kamada-AAT for Inhalation, 80mg, Kamada-AAT for Inhalation, 160mg and placebo)||||||<0.0001
70998829|NCT01628393|141504956|SUPERIORITY||||||<|0.0001||||||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.04944 level of significance to keep the overall level of significance at 0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.||||||<0.0001
70998830|NCT01628393|141504956|SUPERIORITY||||||<|0.0001||||||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.04944 level of significance to keep the overall level of significance at 0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.||||||<0.0001
70998831|NCT01628393|141504957|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.||||||<0.0001
70998832|NCT01628393|141504957|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.||||||<0.0001
70998833|NCT01628393|141504958|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.||||||<0.0001
70998834|NCT01628393|141504958|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.||||||<0.0001
71100356|NCT05486065|141709344|OTHER|The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.|Treatment difference|-0.3||||0.1678|TWO_SIDED|95.0|-0.72|0.13|||ANCOVA|||||0.13|-0.72|0.1678
70998835|NCT01628393|141504959|SUPERIORITY||Rate Ratio|0.47||||0.0531|TWO_SIDED|95.0|0.22|1.01|||Poisson regression model|Adjusted for region, the number of relapses within 24 months prior to the study, and the absence or presence of GdE lesions at Baseline.|Rate ratio = Ozanimod / Placebo|||1.01|0.22|0.0531
70998836|NCT01628393|141504959|SUPERIORITY||Rate Ratio|0.69||||0.2714|TWO_SIDED|95.0|0.36|1.34|||Poisson regression model|Adjusted for region, the number of relapses within 24 months prior to the study, and the absence or presence of GdE lesions at Baseline.|Rate ratio = Ozanimod / Placebo|||1.34|0.36|0.2714
70998837|NCT05441540|141504971|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
70998838|NCT05441540|141504972|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
70998839|NCT05441540|141504973|OTHER|||||||0.7613|||||||Kruskal-Wallis|||||||0.7613
70998840|NCT05441540|141504974|OTHER|||||||0.764|||||||Wilcoxon (Mann-Whitney)|||||||0.7640
70998841|NCT00813917|141504975|SUPERIORITY_OR_OTHER|||||||0.126||95.0||||For this randomized phase II we used a one sided test with a false positive(type I error)rate of 0.20 to assess whether additional studies of the experimental arm are warranted.|Chi-squared|1 sided||Data were compared between treatment groups using Chi Square test.||||0.126
70998842|NCT00270998|141504995|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492||||||A priori threshold for statistical significance set at p = 0.0492 to account for interim analysis|Regression, Logistic|||A priori, the combination treatment was considered superior (75% success rate) to either single-modality therapy (60% success rate) at 80% power with 150 participants per group.||||<0.0492
70998843|NCT00270998|141504995|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.02||||||A priori threshold for statistical significance set at p = 0.0492 to account for interim analysis|Regression, Logistic|||A priori, the combination treatment was considered superior (75% success rate) to either single-modality therapy (60% success rate) at 80% power with 150 participants per group.||||0.02
70998844|NCT00270998|141504995|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.49||||||A priori threshold for statistical significance set at p = 0.0492 to account for interim analysis|Regression, Logistic|||A priori, the combination treatment was considered superior (75% success rate) to either single-modality therapy (60% success rate) at 80% power with 150 participants per group.||||0.49
70998845|NCT00270998|141504996|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.006|||||||Regression, Logistic|||||||0.006
70998846|NCT00270998|141504996|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.048|||||||Regression, Logistic|||||||0.048
70998847|NCT00270998|141504996|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.42|||||||Regression, Logistic|||||||0.42
70998848|NCT00270998|141504997|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
70998849|NCT00270998|141504997|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
70998850|NCT00270998|141504997|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
70998851|NCT00270998|141504998|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
70998852|NCT00270998|141504998|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
70998853|NCT00270998|141504998|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
70998854|NCT00270998|141504999|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
70998855|NCT00270998|141504999|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
70998856|NCT00270998|141504999|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
70998857|NCT00270998|141505000|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
70998858|NCT00270998|141505000|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
70998859|NCT00270998|141505000|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
70998860|NCT00270998|141505001|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.03|||||||Regression, Logistic|||||||0.03
70998861|NCT00270998|141505001|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.048|||||||Regression, Logistic|||||||0.048
70998862|NCT00270998|141505001|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
70998863|NCT00270998|141505002|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
70998864|NCT00270998|141505002|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
70998865|NCT00270998|141505002|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
70998866|NCT00563368|141505003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.76|STANDARD_ERROR_OF_MEAN|0.831||0.0009|TWO_SIDED|95.0|1.13|4.39||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||4.39|1.13|0.0009
70998867|NCT00563368|141505003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.15|STANDARD_ERROR_OF_MEAN|0.825||0.0001|TWO_SIDED|95.0|1.53|4.77||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||4.77|1.53|0.0001
71041691|NCT00835796|141592510|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|94.2|109.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109|94.2|
71041692|NCT00835796|141592511|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.7||||||90.0|94.0|104.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104|94.0|
70998868|NCT00563368|141505003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.49|STANDARD_ERROR_OF_MEAN|0.83|<|0.0001|TWO_SIDED|95.0|5.86|9.12||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||9.12|5.86|<0.0001
70998869|NCT00563368|141505003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.33|STANDARD_ERROR_OF_MEAN|0.832|<|0.0001|TWO_SIDED|95.0|1.69|4.96||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||4.96|1.69|<0.0001
70998870|NCT00563368|141505003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.01|STANDARD_ERROR_OF_MEAN|0.828||0.0003|TWO_SIDED|95.0|1.38|4.63||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||4.63|1.38|0.0003
71100357|NCT05486065|141709344|OTHER|The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.|Treatment difference|-0.25||||0.2445|TWO_SIDED|95.0|-0.67|0.17|||ANCOVA|||||0.17|-0.67|0.2445
71100358|NCT00834587|141709351|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|99.1||||||90.0|92.4|106.2|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.2|92.4|
71100359|NCT00834587|141709352|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.7||||||90.0|98.8|102.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.6|98.8|
71100360|NCT00834587|141709353|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.6||||||90.0|98.8|102.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.5|98.8|
70998871|NCT00563368|141505003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.75|STANDARD_ERROR_OF_MEAN|0.831|<|0.0001|TWO_SIDED|95.0|5.11|8.38||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||8.38|5.11|<0.0001
70998872|NCT00563368|141505004|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.028|STANDARD_ERROR_OF_MEAN|0.5832||0.014|TWO_SIDED|95.0|1.154|3.563||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||3.563|1.154|0.0140
70998873|NCT00563368|141505004|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.246|STANDARD_ERROR_OF_MEAN|0.6418||0.0046|TWO_SIDED|95.0|1.283|3.932||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||3.932|1.283|0.0046
70998874|NCT00563368|141505004|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.623|STANDARD_ERROR_OF_MEAN|3.644|<|0.0001|TWO_SIDED|95.0|5.424|20.81||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||20.81|5.424|<0.0001
70998875|NCT00563368|141505004|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.568|STANDARD_ERROR_OF_MEAN|0.7391||0.0011|TWO_SIDED|95.0|1.46|4.514||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||4.514|1.460|0.0011
70998876|NCT00563368|141505004|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.166|STANDARD_ERROR_OF_MEAN|0.6158||0.0066|TWO_SIDED|95.0|1.241|3.781||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||3.781|1.241|0.0066
70998877|NCT00563368|141505004|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.063|STANDARD_ERROR_OF_MEAN|3.0857|<|0.0001|TWO_SIDED|95.0|4.65|17.66||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||17.66|4.650|<0.0001
71008569|NCT02055976|141525228|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-86.446|STANDARD_ERROR_OF_MEAN|5.855|<|0.001|TWO_SIDED|95.0|-98.074|-74.818|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-74.818|-98.074|<0.001
71100361|NCT00834587|141709354|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|101.7||||||90.0|97.3|106.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.3|97.3|
71100362|NCT00834587|141709355|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|99.2||||||90.0|96.5|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.0|96.5|
70998878|NCT00879437|141505010|NON_INFERIORITY|if 19 evaluable patients enrolled for DIPG, study is powered at 80% to detect a 20% improvement in 1-year EFS compared to historical control if 21 evaluable patients enrolled for HGG, study is powered at 80% to detect a 20% improvement in 1-year EFS compared to historical control|||||<|0.05|||||||Log Rank|one sample log-rank||comparing 1-year EFS of DIPG on this trial versus historical control (1-year EFS of 17% from CCG-9941; PMID 12177103) comparing 1-year EFS of HGG on this trial versus historical control (1-year EFS of 36% from ACNS0126; PMID 21339192)||||< 0.05
70998879|NCT00879437|141505050|OTHER|The Kaplan-Meier method was used to estimate the median EFS for each cohort with 95% confidence intervals. All analyses were performed in SAS version 9.4 statistical software (SAS Institute Inc) and R (https://cran.r-project.org/).|||||||TWO_SIDED|95.0|||||||||The Kaplan-Meier method was used to estimate the median EFS for each cohort with 95% confidence intervals.|||
70998880|NCT00879437|141505051|OTHER|The Kaplan-Meier method was used to estimate the one-year EFS for each cohort with 95% confidence intervals. All analyses were performed in SAS version 9.4 statistical software (SAS Institute Inc) and R (https://cran.r-project.org/).|||||||TWO_SIDED|95.0|||||||||The Kaplan-Meier method was used to estimate the one-year EFS for each cohort with 95% confidence intervals.|||
70998881|NCT00879437|141505052|OTHER|||||||||||||||||partial response defined as 51% to 99% reduction in tumor size,determined using WHO bi-dimensional criteria (product of the greatest tumor diameter and its perpendicular diameter)|Not applicable (8 partial responses in 16 patients = 50%)|||
71100363|NCT00834587|141709356|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|99.1||||||90.0|96.5|101.8|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.8|96.5|
71100364|NCT03449147|141709404|SUPERIORITY||Estimated Relative Reduction (%)|-1.14||||0.875|TWO_SIDED|95.0|-14.27|14.02||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 24 based on log transformed data.||14.02|-14.27|0.875
71100365|NCT03449147|141709404|SUPERIORITY||Estimated Relative Reduction (%)|-14.64||||0.031|TWO_SIDED|95.0|-26.07|-1.43||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||ERR relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 24 based on log transformed data.||-1.43|-26.07|0.031
70998882|NCT00763243|141505057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_DEVIATION|2.17||0.766|TWO_SIDED|95.0|-1.44|1.89|||t-test, 2 sided|t(8)=0.31||Change during waiting period (no intervention); no change was hypothesized||1.89|-1.44|0.766
70998883|NCT00763243|141505057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67|STANDARD_DEVIATION|1.0|<|0.001|TWO_SIDED|95.0|0.9|2.44|||t-test, 2 sided|t(8)=5.0||Change during the training period||2.44|0.90|<0.001
70998884|NCT00763243|141505057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.78|STANDARD_DEVIATION|1.86||0.021|TWO_SIDED|95.0|0.35|3.2|||t-test, 2 sided|t(8)=2.87||Change from pre-training through follow-up period||3.20|0.35|0.021
70998885|NCT00763243|141505057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|STANDARD_DEVIATION|1.12||0.4|TWO_SIDED|95.0|-0.53|1.19|||t-test, 2 sided|t(8)=0.89||Change from pretraining to 6 month follow up||1.19|-0.53|0.40
70998886|NCT00763243|141505058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.33|STANDARD_DEVIATION|2.24||0.11|TWO_SIDED|95.0|-0.39|3.05|||t-test, 2 sided|t(8)=1.79||Change during waiting period of no intervention||3.05|-0.39|0.11
70998887|NCT00763243|141505058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.44|STANDARD_DEVIATION|1.81||0.004|TWO_SIDED|95.0|1.05|3.84|||t-test, 2 sided|t(8)=4.05||Change during training period||3.84|1.05|0.004
70998888|NCT00763243|141505058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.11|STANDARD_DEVIATION|3.06||0.072|TWO_SIDED|95.0|-0.24|4.46|||t-test, 2 sided|t(8)=2.07||1 Month Follow Up change from pre-training||4.46|-0.24|0.072
70998889|NCT00763243|141505058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.78|STANDARD_DEVIATION|2.28||0.34|TWO_SIDED|95.0|-0.97|2.53|||t-test, 2 sided|t(8)=1.02||6 month follow up change from pre-training||2.53|-0.97|0.34
70998890|NCT00763243|141505059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_DEVIATION|1.86||0.729|TWO_SIDED|95.0|-1.2|1.65|||t-test, 2 sided|t(8)=0.36||Waiting period - no treatment||1.65|-1.20|0.729
70998891|NCT00763243|141505059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.78|STANDARD_DEVIATION|2.17||0.039|TWO_SIDED|95.0|-3.44|-0.11|||t-test, 2 sided|t(8)=2.46||Training Period - Pretraining to Post-Training Visit||-0.11|-3.44|0.039
70998892|NCT00763243|141505059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|STANDARD_DEVIATION|2.98||0.4|TWO_SIDED|95.0|-3.17|1.4|||t-test, 2 sided|t(8)=0.90||1 Month Follow Up Period from Pretraining||1.40|-3.17|0.40
70998893|NCT00763243|141505059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_DEVIATION|2.5||0.4|TWO_SIDED|95.0|-2.59|1.26|||t-test, 2 sided|t(8)=0.89||6 Month Follow Up period from pretraining||1.26|-2.59|0.40
70998894|NCT00753623|141505069|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
70998895|NCT03332303|141505070|EQUIVALENCE|If the 90% confidence interval (calculated using Yates' continuity correction) on the absolute difference between the proportion of patients identified as Responders in the Test and Reference groups (pT - pR) is contained within the range \[-20%, +20%\] then therapeutic equivalence of the Test product to the Reference product was considered to have been demonstrated.|Mean Difference (Final Values)|-5.1|||||TWO_SIDED|90.0|-13.0|2.8||||||Therapeutic equivalence was evaluated for both primary and secondary endpoints in the per-protocol (PP) population.||2.8|-13.0|
70998896|NCT03332303|141505070|SUPERIORITY||% Difference|23.4|||<|0.0001|TWO_SIDED|||||The a priori threshold for statistical significance is p \< 0.05.|Cochran-Mantel-Haenszel|||Superiority of the Test and Reference products against the Placebo product for the primary endpoint was evaluated in the modified Intent-to-Treat (mITT) population using last observation carried forward (LOCF).||||<0.0001
70998897|NCT03332303|141505070|SUPERIORITY||% Difference|28.7|||<|0.0001|TWO_SIDED|||||The a priori threshold for statistical significance is p \< 0.05.|Cochran-Mantel-Haenszel|||Superiority of the Test and Reference products against the Placebo product for the primary endpoint was evaluated in the modified Intent-to-Treat (mITT) population using last observation carried forward (LOCF).||||<0.0001
70998898|NCT03332303|141505071|EQUIVALENCE|If the 90% confidence interval (calculated using Yates' continuity correction) on the absolute difference between the proportion of patients identified as Treatment Successes in the Test and Reference groups (pT - pR) is contained within the range \[-20%, +20%\] then therapeutic equivalence of the Test product to the Reference product was considered to have been demonstrated.|Mean Difference (Final Values)|-2.0|||||TWO_SIDED|90.0|-10.7|6.7||||||Therapeutic equivalence was evaluated for both primary and secondary endpoints in the per-protocol (PP) population.||6.7|-10.7|
70998899|NCT03332303|141505071|SUPERIORITY|To conclude superiority of the Test product over Placebo, the proportion of Treatment Successes in the Test product group must be numerically and statistically superior to that of the Placebo (p \< 0.05; using a two-sided Cochran-Mantel-Haenszel \[CMH\] test).|% Difference|-0.8||||0.8068|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Superiority of the Test and Reference products against the Placebo product for the secondary endpoint was evaluated in the modified Intent-to-Treat (mITT) population using last observation carried forward (LOCF).||||0.8068
70998900|NCT03332303|141505071|SUPERIORITY|To conclude superiority of the Reference product over Placebo, the proportion of Treatment Successes in the Reference product group must be numerically and statistically superior to that of the Placebo (p \< 0.05; using a two-sided Cochran-Mantel-Haenszel \[CMH\] test).|% Difference|1.8||||0.8003|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Superiority of the Test and Reference products against the Placebo product for the secondary endpoint was evaluated in the modified Intent-to-Treat (mITT) population using last observation carried forward (LOCF).||||0.8003
70998901|NCT00425100|141505084|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0|STANDARD_DEVIATION|3.1|<|0.0001||95.0|-3.2|-2.7||All paired t-tests were performed with a two-sided test at significance level of 5%. Efficacy was claimed only when all 3 primary diary endpoints demonstrated statistical significance in change from baseline to Week 12.|2-sided paired t-test|paired t-test comparing baseline with post-baseline values||Open-label study with statistical comparison between baseline and Week 12. Null hypothesis: The mean change from baseline in number of micturition episodes per 24 hours at Week 12 is equal to 0. The sample size was based on a statistical power for each of the three individual diary endpoints of .95 which would yield an overall power of 85%.||-2.7|-3.2|<0.0001
70998902|NCT00425100|141505085|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7|STANDARD_DEVIATION|2.4|<|0.0001||95.0|-2.0|-1.4||All paired t-tests were performed with a two-sided test at significance level of 5%. Efficacy was claimed only when all 3 primary diary endpoints demonstrated statistical significance in change from baseline to Week 12.|2-sided paired t-test|paired t-test comparing baseline with post-baseline values||Open-label study with statistical comparison between baseline and Week 12. Null hypothesis: The mean change from baseline in number of urgency urinary incontinence per 24 hours is equal to 0. The sample size was based on a statistical power for each of the three individual diary endpoints of .95 which would yield an overall power of 85%.||-1.4|-2.0|<0.0001
70998903|NCT00425100|141505086|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.0|STANDARD_DEVIATION|4.8|<|0.0001||95.0|-5.4|-4.5||All paired t-tests were performed with a two-sided test at significance level of 5%. Efficacy was claimed only when all 3 primary diary endpoints demonstrated statistical significance in change from baseline to Week 12.|2-sided paired t-test|paired t-test comparing baseline with post-baseline values||Open-label study with statistical comparison between baseline and Week 12. Null hypothesis: The mean change from baseline in number of urgency episodes per 24 hours is equal to 0. The sample size was based on a statistical power for each of the three individual diary endpoints of .95 which would yield an overall power of 85%.||-4.5|-5.4|<0.0001
70998904|NCT00425100|141505088|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|1.2|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2 sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
70998905|NCT00425100|141505089|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.5|STANDARD_DEVIATION|4.1|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
70998906|NCT00425100|141505090|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|0.7|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
70998907|NCT00425100|141505091|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_DEVIATION|1.3|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
70998908|NCT00425100|141505093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_DEVIATION|0.7|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
71100366|NCT03449147|141709407|SUPERIORITY||Estimated Relative Reduction (%)|-3.03||||0.677|TWO_SIDED|95.0|-16.14|12.12||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 24 based on log transformed data.||12.12|-16.14|0.677
71100367|NCT03449147|141709407|SUPERIORITY||Estimated Relative Reduction (%)|-15.79||||0.022|TWO_SIDED|95.0|-27.27|-2.5||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||ERR relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 24 based on log transformed data.||-2.50|-27.27|0.022
70998909|NCT00425100|141505095|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.6|STANDARD_DEVIATION|26.4|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
70998910|NCT00425100|141505096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|30.6|STANDARD_DEVIATION|26.6|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
71041693|NCT00835796|141592512|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.8||||||90.0|94.5|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|94.5|
71041694|NCT00951093|141592528|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P value adjusted for multiple comparisons|Friedman´s test|followed by nonparametric pairwise multiple comparisons||||||<0.001
70923887|NCT01820260|141339732|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||z-test|||To account for multiple testing among the secondary endpoints, a hierarchical order of testing was determined, where the following evaluation was done separately for each of the four active groups: Provided the primary endpoint was significant at a 1.25% level, the comparison to vehicle in terms of reduction in AK count from baseline to week 8 was tested at a 1.25% level. Provided this test was significant, the second secondary endpoint,partial clearance, was tested(vs. vehicle) at a 1.25% level||||< 0.001
70923888|NCT01820260|141339732|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||z-test|||See comment in analysis 1||||< 0.001
71041695|NCT00951093|141592529|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||Friedman´s test|followed by nonparametric pairwise multiple comparisons||||||0.002
71041696|NCT00951093|141592530|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Friedman´s test|||||||< 0.001
71100368|NCT03449147|141709408|SUPERIORITY||Odds Ratio (OR)|1.34||||0.077|TWO_SIDED|95.0|0.97|1.85||Comparison based on logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline LCQ total score, and the interaction of baseline LCQ total score by visit as covariates.|Regression, Logistic|||||1.85|0.97|0.077
71100369|NCT03449147|141709408|SUPERIORITY||Odds Ratio (OR)|1.41||||0.04|TWO_SIDED|95.0|1.02|1.96||Comparison based on logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline LCQ total score, and the interaction of baseline LCQ total score by visit as covariates.|Regression, Logistic|||||1.96|1.02|0.040
71100370|NCT03449147|141709409|SUPERIORITY||Odds Ratio (OR)|1.03||||0.872|TWO_SIDED|95.0|0.75|1.4||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline 24-hour coughs per hour and the interaction of baseline 24-hour coughs per hour as covariates.|Regression, Logistic|||||1.40|0.75|0.872
70998911|NCT00425100|141505097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.9|STANDARD_DEVIATION|27.3|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
70998912|NCT00425100|141505098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.8|STANDARD_DEVIATION|21.1|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
70923889|NCT01820260|141339732|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||z-test|||See comment analysis 1||||< 0.001
71041697|NCT00951093|141592531|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.02||95.0|||||Wilcoxon (Mann-Whitney)|followed by nonparametric pairwise multiple comparisons||||||< 0.020
71041698|NCT00951093|141592532|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|followed by nonparametric pairwise multiple comparisons||||||< 0.001
71041699|NCT00951093|141592533|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||Wilcoxon (Mann-Whitney)|followed by nonparametric pairwise multiple comparisons||||||0.001
71041700|NCT00951093|141592534|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Friedman´s test|followed by nonparametric pairwise multiple comparisons||||||< 0.001
71041701|NCT04412057|141592571|SUPERIORITY||Odds Ratio (OR)|2.86||||0.044|TWO_SIDED|90.0|1.04|7.88|||Regression, Logistic|||The sample size provided greater than 80% power to detect a difference of 0.25 in the proportion of subjects alive and free of respiratory failure using a Chi-square exact test at a one-sided significance level of 0.05. This calculation assumed that the proportion alive and free of respiratory failure will be 0.60 in the placebo group and 0.85 in the CERC-002 group.||7.88|1.04|0.0440
71041702|NCT04412057|141592572|SUPERIORITY||Odds Ratio (OR)|2.0||||0.1762|TWO_SIDED|90.0|0.59|6.82|||Regression, Logistic|||The proportion of subjects alive at Day 28/ET in the CERC-002 group was compared to that in the placebo group using logistic regression methods. The logistic regression model included terms for treatment group. Model based point estimate (i.e., odds ratio \[OR\]), 90% confidence interval \[CI\], and one-sided p-value were reported.||6.82|0.59|0.1762
71041703|NCT02156154|141592573|SUPERIORITY||Median Difference (Final Values)|-0.04||||0.29|TWO_SIDED|95.0|-0.18|0.11||significance criterion of P \< .044.|Wilcoxon (Mann-Whitney)||Difference = IV Acetaminophen - Placebo group|A total of 28 patients (5%) were missing monitoring data (14 patients in each group). Values for these patients were obtained using multivariable imputation with 5 imputation data sets. The imputation regression model included all of the baseline, intraoperative, surgical, and postanesthesia care unit variables and all of the secondary outcomes||0.11|-0.18|0.29
71041704|NCT02156154|141592574|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.07|TWO_SIDED|99.4|-0.71|0.15||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|t-test, 2 sided||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|||0.15|-0.71|0.07
71041705|NCT02156154|141592575|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.46|TWO_SIDED|99.4|-0.51|0.29||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|t-test, 2 sided||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|||0.29|-0.51|0.46
71041706|NCT02156154|141592576|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.56|TWO_SIDED|99.4|-0.49|0.76||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|t-test, 2 sided||Treatment effect data are reported as differences in means between the study groups, assessed using a 2-sample t test.|||0.76|-0.49|0.56
71041707|NCT02156154|141592577|SUPERIORITY||Mean Difference (Net)|-0.08||||0.3|TWO_SIDED|99.4|-0.29|0.13||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|t-test, 2 sided||Treatment effect data are reported as differences in means between the study groups, assessed using a 2-sample t test.|||0.13|-0.29|0.30
71041708|NCT02156154|141592578|SUPERIORITY||Ratios of geometric means|0.94||||0.65|TWO_SIDED|99.4|0.63|1.39||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|t-test, 2 sided||Treatment effect data are reported as ratios of geometric means, assessed using a 2-sample t test after logarithmic transformation of outcomes.|||1.39|0.63|0.65
71041709|NCT02156154|141592579|SUPERIORITY||Ratios of geometric means|0.86||||0.22|TWO_SIDED|99.4|0.61|1.21|||t-test, 2 sided||Treatment effect data are reported as ratios of geometric means, assessed using a 2-sample t test after logarithmic transformation of outcomes.|||1.21|0.61|0.22
71041710|NCT02156154|141592580|SUPERIORITY||Risk Ratio (RR)|1.13||||0.18|TWO_SIDED|99.4|0.88|1.45||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|Chi-squared||Risk ratio = Treatment/Placebo|||1.45|0.88|0.18
71041711|NCT02156154|141592581|SUPERIORITY||Risk Ratio (RR)|0.9||||0.53|TWO_SIDED|99.4|0.57|1.43||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|Chi-squared||RR = Treatment/Placebo|||1.43|0.57|0.53
71041712|NCT02156154|141592582|SUPERIORITY||Median Difference (Final Values)|0.0||||0.99|TWO_SIDED|99.4|-0.39|0.36||Adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|Wilcoxon (Mann-Whitney)||Treatment effect is reported as median difference, estimated using the Hodges-Lehmann estimator of location shift.|||0.36|-0.39|0.99
71100371|NCT03449147|141709409|SUPERIORITY||Odds Ratio (OR)|1.33||||0.082|TWO_SIDED|95.0|0.96|1.83||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline 24-hour coughs per hour and the interaction of baseline 24-hour coughs per hour as covariates.|Regression, Logistic|||||1.83|0.96|0.082
70923890|NCT01820260|141339732|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||z-test|||See comment in analysis 1||||< 0.001
71041713|NCT02051595|141592583|SUPERIORITY_OR_OTHER||estimate (beta) from mixed model|-0.068|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|-0.098|-0.039||A priori threshold was set to p \< 0.05.|Mixed Models Analysis|Analyses modeled change in vancomycin concentrations (independent variable defined by time). Analyses were adjusted for covariates.|Negative beta value indicates that vancomycin concentration decreased following cardiopulmonary bypass (CPB).|||-0.039|-0.098|<0.0001
71041714|NCT00407745|141592586|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.198||0.0032|TWO_SIDED|95.0|-0.98|-0.2||Significance was declared if the 2-tailed test for the difference between treatment groups was significant at the 0.05 level.|ANCOVA|||"Null hypothesis - the mean DAAC for the pregabalin group is equal to the mean DAAC for the placebo group; Alternative hypothesis - the mean DAAC for the placebo group differs from the mean DAAC for the pregabalin group.~ANCOVA model included baseline severity of pain and Baseline Pain Catastrophizing Scale (PCS) Total Score as covariates and pooled center and treatment as fixed (class) cofactors."||-0.20|-0.98|0.0032
71041715|NCT00407745|141592587|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.255||0.0066|TWO_SIDED|95.0|-1.2|-0.2||Serial gate-keeping multiple testing procedure was used. If primary comparison for DAAC was significant, then variables were assessed in a hierarchical manner. Significance was declared if unadjusted p-value was significant at 0.05 level (\<=0.05).|ANCOVA|ANCOVA model included baseline severity (pain) and baseline PCS as covariates and effects for treatment and pooled center as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-0.20|-1.20|0.0066
71041716|NCT00407745|141592588|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.85||||0.039|TWO_SIDED|95.0|1.032|3.328||Serial gate-keeping multiple testing was used. If primary comparison for DAAC was significant, then variables were assessed in hierarchical manner. Significance was declared if unadjusted p-value at 0.05 level and preceding tests were significant.|Regression, Logistic|Logistic regression model used terms for baseline pain score and baseline PCS total score as covariate, and pooled center and treatment as cofactor.||Null hypothesis - The rate of responder for the pregabain group was equal to the rate of responder for the placebo group; Alternative hypothesis - The rate of responder for the pregabain group was not equal to the rate of responder for the placebo group||3.328|1.032|0.0390
71041717|NCT00407745|141592589|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006||95.0||||Serial gate-keeping multiple testing was used. If primary comparison for DAAC was significant, then variables were assessed in hierarchical manner. Significance was declared if unadjusted p-value at 0.05 level and preceding tests were significant.|Cochran-Mantel-Haenszel|Modified ridit transformation with the Cochran-Mantel- Haenszel test was used with adjusting for pooled center.||Null hypothesis - The raw mean score for the pregabain group was equal to the raw mean score for the placebo group; Alternative hypothesis - The raw mean score for the pregabain group was not equal to the raw mean score for the placebo group.||||0.0006
71041718|NCT00407745|141592590|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.265|<|0.0001|TWO_SIDED|95.0|-1.6|-0.56||Serial gate-keeping multiple testing was used. If primary comparison for DAAC was significant, then variables were assessed in hierarchical manner. Significance was declared if unadjusted p-value at 0.05 level and preceding tests were significant.|ANCOVA|ANCOVA model included baseline sleep interference score as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-0.56|-1.60|<0.0001
71041719|NCT00407745|141592591|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.23||0.0295|TWO_SIDED|95.0|-0.94|-0.05||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 1~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.05|-0.94|0.0295
71100372|NCT03449147|141709410|OTHER||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.96|1.83||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly CSD total score, and the interaction of baseline mean weekly CSD total score by visit as covariates.||1.83|0.96|
70998913|NCT00425100|141505099|SUPERIORITY_OR_OTHER||Mean Difference (Net)|26.1|STANDARD_DEVIATION|22.8|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
70998914|NCT00425100|141505100|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.7|STANDARD_DEVIATION|22.7|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
70998915|NCT00425100|141505102|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.2|STANDARD_DEVIATION|14.2|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
70998916|NCT03258632|141505123|SUPERIORITY||Odds Ratio (OR)|1.17|||<|0.05|TWO_SIDED|95.0|0.73|1.9|||Mixed Models Analysis|||||1.90|0.73|<.05
70998917|NCT00187889|141505125|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.6|STANDARD_ERROR_OF_MEAN|6.7||0.15|TWO_SIDED|95.0|-22.8|3.6||The P-value applies to this comparison, without adjustment, to the completers of the trial.|Satterthwaite corrected t-test||An expanded definition of the outcome measure is the difference between the percentage change (week 16) and the percentage change week 0). This is a calculation based on 4 measurements.|The null hypothesis is that the treatments are equivalent with respect to the primary outcome. The Satterthwaite corrected t-tests adjusts for potentially unequal variance in the groups.||3.6|-22.8|0.15
70998918|NCT00187889|141505125|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.39||0.92|TWO_SIDED|95.0|-0.79|0.72|||Satterthwaite corrected t-test||The Satterthwaite corrected t-tests adjusts for potentially unequal variance in the groups. This is a different outcome variable than the primary.|The null hypothesis is that treatments are equivalent on this outcome. The study was powered around the primary outcome. No adjustment for multiple comparisons was planned.||0.72|-0.79|0.92
70998919|NCT04046341|141505131|OTHER|||||||0.008||||||A priori statistical significance threshold = p\<.05|McNemar|||||||.008
70998920|NCT04046341|141505132|SUPERIORITY|||||||0.014||||||A priori statistical significance threshold = p\<.05|t-test, 2 sided|||||||.014
70998921|NCT04046341|141505133|SUPERIORITY|||||||0.013||||||A priori statistical significance threshold = p\<.05|t-test, 2 sided|||||||.013
70998922|NCT04046341|141505134|SUPERIORITY|||||||0.001||||||A priori statistical significance threshold = p\<.05|t-test, 2 sided|||||||.001
70998923|NCT04046341|141505135|SUPERIORITY|||||||0.209||||||A priori statistical significance threshold = p\<.05|t-test, 2 sided|||||||.209
70998924|NCT01575899|141505138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.629|STANDARD_ERROR_OF_MEAN|3.1526||0.008|TWO_SIDED|95.0|1.28|5.42|||Chi-squared|||||5.42|1.28|0.008
70998925|NCT01575899|141505140|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.87|STANDARD_ERROR_OF_MEAN|3.2589||0.004|TWO_SIDED|95.0|1.5|10.02|||Chi-squared|||||10.02|1.5|0.004
70998926|NCT02758119|141505163|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70998927|NCT01569087|141505174|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher Exact|||||||<0.05
70998928|NCT00771173|141505180|SUPERIORITY_OR_OTHER|||||||0.745|TWO_SIDED||||||t-test, 2 sided|||The independent samples t-test was used to test the null hypothesis that the mean VAS score for the active treatment cohort (i.e., those receiving pyridium) was no different than the mean VAS score for those receiving placebo.||||.745
70998929|NCT01602549|141505182|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.965|||||TWO_SIDED|95.0|0.831|1.12|||||Day 1: The adjusted means (AMs) and ratios were estimated using a mixed model (MM) fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|GSK962040 50 mg : Placebo Day 1||1.120|0.831|
70998930|NCT01602549|141505182|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.886|||||TWO_SIDED|95.0|0.763|1.029|||||Day 8: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|GSK962040 50 mg : Placebo Day 8||1.029|0.763|
70998931|NCT01602549|141505182|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.937|||||TWO_SIDED|95.0|0.85|1.033|||||Day 8:Day 1: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|Day 8: Day 1||1.033|0.850|
71100373|NCT03449147|141709410|OTHER||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|1.08|2.09||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly CSD total score, and the interaction of baseline mean weekly CSD total score by visit as covariates.||2.09|1.08|
71100374|NCT03449147|141709411|OTHER||Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.93|1.69||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly CSD total score, and the interaction of baseline mean weekly CSD total score by visit as covariates.||1.69|0.93|
70998932|NCT01602549|141505182|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|1.02|||||TWO_SIDED|95.0|0.89|1.17|||||Day 8:Day 1: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|Day 8:Day 1 Placebo||1.170|0.890|
70998933|NCT01602549|141505184|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.864|||||TWO_SIDED|95.0|0.702|1.064|||||Day 1: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|GSK962040 50 mg Vs Placebo Day 1||1.064|0.702|
70998934|NCT01602549|141505184|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|1.018|||||TWO_SIDED|95.0|0.824|1.257|||||Day 8: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|GSK962040 50 mg Vs Placebo Day 8||1.257|0.824|
70998935|NCT01602549|141505184|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|1.018|||||TWO_SIDED|95.0|0.889|1.166|||||Day 8:Day 1: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|Day 8 VS Day 1 GSK962040 50 mg||1.166|0.889|
70998936|NCT01602549|141505184|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.865|||||TWO_SIDED|95.0|0.709|1.055|||||Day 8:Day 1: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|Day 8 Vs Day 1 Placebo||1.055|0.709|
70998937|NCT01602549|141505185|SUPERIORITY_OR_OTHER|||||||0.157||95.0|||||Wilcoxon rank-sum test|||Day 1||||0.157
70998938|NCT01602549|141505185|SUPERIORITY_OR_OTHER|||||||0.186||95.0|||||Wilcoxon rank-sum test|||Day 8||||0.186
70998939|NCT01602549|141505187|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-4.239|||||TWO_SIDED|95.0|-16.015|7.537|||||Day 1: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit, and Baseline gastric half emptying time as fixed effects, and participant as a random effect.|GSK962040 50 mg Vs Placebo Day 1||7.537|-16.015|
70998940|NCT01602549|141505187|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-5.327|||||TWO_SIDED|95.0|-17.567|6.914|||||Day 8: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit, and Baseline gastric half emptying time as fixed effects, and participant as a random effect.|GSK962040 50 mg Vs Placebo Day 8||6.914|-17.567|
70998941|NCT01602549|141505188|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-2.16||||||95.0|-3.9|-0.41|||||Day 1; Part I: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part I-GSK962040 50 mg Vs Placebo Day 1||-0.41|-3.90|
71100375|NCT03449147|141709411|OTHER||Odds Ratio (OR)|1.77|||||TWO_SIDED|95.0|1.31|2.39||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly CSD total score, and the interaction of baseline mean weekly CSD total score by visit as covariates.||2.39|1.31|
70998942|NCT01602549|141505188|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.63|||||TWO_SIDED|95.0|-5.41|-1.85|||||Day 8; Part I: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part I-GSK962040 50 mg Vs Placebo Day 8||-1.85|-5.41|
70998943|NCT01602549|141505188|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-2.29|||||TWO_SIDED|95.0|-4.65|0.07|||||Day 1; Part II: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part II- GSK962040 50 mg Vs Placebo Day 1||0.07|-4.65|
70998944|NCT01602549|141505188|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-2.46|||||TWO_SIDED|95.0|-4.85|-0.07|||||Day 8; Part II: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part II- GSK962040 50 mg Vs Placebo Day 8||-0.07|-4.85|
70998945|NCT01602549|141505188|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-5.38|||||TWO_SIDED|95.0|-10.28|-0.49|||||Day 8; Part III: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part III -GSK962040 50 mg Vs Placebo Day 8||-0.49|-10.28|
70998946|NCT01602549|141505188|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-0.56|||||TWO_SIDED|95.0|-1.65|0.54|||||Day 1; Part IV: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part IV-GSK962040 50 mg Vs Placebo Day 1||0.54|-1.65|
71100376|NCT03449147|141709412|OTHER||Odds Ratio (OR)|1.53|||||TWO_SIDED|95.0|1.14|2.05||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly VAS score, and the interaction of baseline mean weekly VAS score by visit as covariates.||2.05|1.14|
71100377|NCT03449147|141709412|OTHER||Odds Ratio (OR)|1.65||||||95.0|1.23|2.22||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly VAS score, and the interaction of baseline mean weekly VAS score by visit as covariates.||2.22|1.23|
70998947|NCT01602549|141505188|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-0.9|||||TWO_SIDED|95.0|-2.02|0.22|||||Day 8; Part IV: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part IV-GSK962040 50 mg Vs Placebo Day 8||0.22|-2.02|
71100378|NCT02931539|141709417|SUPERIORITY||Difference in percentage of responders|32.8|||<|0.001|TWO_SIDED|95.0|22.8|42.74|||Cochran-Mantel-Haenszel|||||42.74|22.80|<0.001
71100379|NCT02931539|141709418|SUPERIORITY||Difference in percentage of responders|9.5||||0.013|TWO_SIDED|95.0|2.02|16.88|||Cochran-Mantel-Haenszel|||||16.88|2.02|0.013
70998948|NCT01602549|141505188|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-6.69|||||TWO_SIDED|95.0|-13.77|0.39|||||Day 1; Total: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Total- GSK962040 50 mg Vs Placebo Day 1||0.39|-13.77|
70998949|NCT01602549|141505188|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-12.5|||||TWO_SIDED|95.0|-19.67|-5.29|||||Day 8; Total: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Total- GSK962040 50 mg Vs Placebo Day 8||-5.29|-19.67|
70998950|NCT01602549|141505188|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-1.7|||||TWO_SIDED|95.0|-6.53|3.13|||||Day 1; Part III: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part III- GSK962040 50 mg Vs Placebo Day 1||3.13|-6.53|
70998951|NCT01602549|141505189|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.14|||||TWO_SIDED|95.0|-9.07|2.78|||||Day 1; Pre-dose: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|Pre dose: GSK962040 50 mg Vs Placebo Day 1||2.78|-9.07|
70998952|NCT01602549|141505189|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.18|||||TWO_SIDED|95.0|-9.11|2.75|||||Day 1; 120 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|120 min PD: GSK962040 50 mg Vs Placebo Day 1||2.75|-9.11|
71041720|NCT00407745|141592591|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.23||0.0033|TWO_SIDED|95.0|-1.11|-0.22||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 2~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.22|-1.11|0.0033
71100380|NCT02931539|141709433|OTHER||Hazard Ratio (HR)|1.14||||0.647|TWO_SIDED|95.0|0.549|2.357|||Log Rank|Two-sided p-value comparing treatment groups was calculated from the log rank test by Kaplan-Meier Method.|Stratified Cox regression model was used as transplant type and baseline plasma CMV DNA level as stratification factors.|||2.357|0.549|0.647
71100381|NCT02059642|141709443|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.1||||0.1358|TWO_SIDED|95.0|-4.87|0.66|||Mixed Models Analysis|MMRM: Model of Repeated Measures||||0.66|-4.87|0.1358
71100382|NCT00993473|141709550|NON_INFERIORITY_OR_EQUIVALENCE|"Noninferiority would be demonstrated if the upper bound of the 95% confidence interval (CI) for the ratio of the rate of all hypoglycemia in the Lantus group to the rate in the NPH group was \<1.15. Superiority would be demonstrated if the upper bound of the 95% CI was \<1. The margin for noninferiority corresponded to one-half of the 30% difference in hypoglycemia event rate considered as a clinically significant difference by American Diabetes Association 2005 Working Group on Hypoglycemia."|Risk Ratio (RR)|1.18|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|0.97|1.44|||Generalized Linear Model|"A stepwise closed testing approach was used for the primary all hypoglycemia outcome analysis to assess noninferiority and superiority sequentially."|Risk ratio between treatment groups (Lantus/NPH) estimated by Generalized Linear Model with fixed effect terms for randomization strata and treatment.|"The sample size was calculated to ensure sufficient power so that the upper bound of the 2-sided 95% CI for the Lantus /NPH ratio would not exceed 1.15 based on an expected overall rate of all hypoglycemia of 80 events per patient-year of exposure to NPH insulin and to Lantus. It was planned to randomize at least 45 and up to approximately 60 patients in each of the 2 treatment groups so that at least 70 patients would complete the 24 weeks of treatment."||1.44|0.97|
71100383|NCT03707821|141709566|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores. Non-inferiority was declared in the lower limit of the 95% credible interval was above 5.|Mean Difference (Net)|3.3|STANDARD_DEVIATION|2.65|||TWO_SIDED|95.0|-2.0|8.5|||Bayesian normal random-effects|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test minus Control.|It was calculated that 224 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect a 5 points difference in mean overall comfort at he 2-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05).||8.5|-2.0|
71100384|NCT03707821|141709567|NON_INFERIORITY|A cumulative odds ratio non-inferiority margin of 2 was used. This margin is based on a 10% difference if the proportion of subjects that report a higher rating/experience.|Mean Difference (Final Values)|0.08|STANDARD_DEVIATION|0.034|||TWO_SIDED|95.0|0.02|0.15|||Bayesian random -effects model|A 95% Credible Interval for the Posterior proportion mean difference between the Test and Control was used to test for non-inferiority.|mean difference was calculated as Test minus Control.|It was calculated that 40 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect a 10% difference in proportion of subjects that reported at higher rating (Strongly Agree and Agree) with the Test compared to the Control lens at the 2-week follow-up. Sample size was determined using simulation-based methods (alpha=0.05).||0.15|0.02|
71041721|NCT00407745|141592591|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.23||0.0185|TWO_SIDED|95.0|-0.98|-0.09||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 3~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.09|-0.98|0.0185
71041722|NCT00407745|141592591|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.23||0.004|TWO_SIDED|95.0|-1.1|-0.21||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 4~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.21|-1.10|0.0040
71100385|NCT03707821|141709568|NON_INFERIORITY|A non-inferiority margin of 0.05 points was used. This margin corresponds to a half line difference.|Mean Difference (Final Values)|-0.03|STANDARD_DEVIATION|0.008|||TWO_SIDED|95.0|-0.04|-0.01|||Bayesian Normal Random effects model|A 95% Credible Interval for the Posterior mean difference between the Test and control was used to test for non-inferiority.|Mean difference was calculated as Test minus Control.|It was calculated that 30 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect a 0.05 difference in LogMAR visual acuity at the 2-week follow-up. Sample size was determined using simulations methods for repeated measures.||-0.01|-0.04|
70998953|NCT01602549|141505189|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.66|||||TWO_SIDED|95.0|-9.59|2.27|||||Day 1; 180 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|180 min PD: GSK962040 50 mg Vs Placebo Day 1:||2.27|-9.59|
70998954|NCT01602549|141505189|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-4.15|||||TWO_SIDED|95.0|-10.07|1.76|||||Day 1; 240 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|240 min PD: GSK962040 50 mg Vs Placebo Day 1||1.76|-10.07|
70998955|NCT01602549|141505189|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-6.8|||||TWO_SIDED|95.0|-12.79|-0.81|||||Day 8; Pre-dose: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|Pre dose: GSK962040 50 mg Vs Placebo Day 8||-0.81|-12.79|
70998956|NCT01602549|141505189|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.97|||||TWO_SIDED|95.0|-9.96|2.03|||||Day 8; 120 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|120 min PD: GSK962040 50 mg Vs Placebo Day 8||2.03|-9.96|
70998957|NCT01602549|141505189|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-5.29|||||TWO_SIDED|95.0|-11.29|0.71|||||Day 8; 180 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|180 min PD: GSK962040 50 mg Vs Placebo Day 8||0.71|-11.29|
70998958|NCT01602549|141505189|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-8.9|||||TWO_SIDED|95.0|-14.88|-2.91|||||Day 8; 240 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|240 min PD: GSK962040 50 mg Vs Placebo Day 8||-2.91|-14.88|
71100386|NCT03707821|141709569|SUPERIORITY|A superiority margin of 90% was used. Lower limit of 95% credible interval was compared to 90%|Mean Percentage of Acceptable Fitting|99.5|STANDARD_DEVIATION|0.38|||TWO_SIDED|95.0|98.5|100.0|||Bayesian Beta-Binomial Model|model for correlated data||It was calculated that 100 participants were required to show that the acceptable lens fitting for the Test lens would be superior to 90% with at least 80% power. Sample size was determined using simulations methods for repeated measures.||100|98.5|
71100387|NCT03707821|141709570|NON_INFERIORITY|A non-inferiority margin of 5% was used. Upper limit of the 95% credible interval was compared to 5%|Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0036|||TWO_SIDED|95.0|-0.007|0.008|||Bayesian beta-binomial model|model for correlated data|mean difference was calculated as Test minus Control.|It was calculated that 224 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect 5% difference between the Test and Control lens with respect to the proportion of eyes with Grade 3 or higher slit lamp findings across all study visits. Sample size was determined using simulations methods. Sample size for this study was primarily driven by the slit lamp findings.||0.008|-0.007|
70998959|NCT01602549|141505190|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-2.31|||||TWO_SIDED|95.0|-3.71|-0.9|||||OFF: Treatment Period: The AMs and differences (GSK962040 minus Placebo) were estimated using an analysis of covariance (ANCOVA) model fitting treatment and Baseline amount of hours spent ON/OFF as main effects.|OFF: Treatment Period||-0.90|-3.71|
70998960|NCT01602549|141505190|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|1.88|||||TWO_SIDED|95.0|0.28|3.48|||||ON: Treatment Period: The AMs and differences (GSK962040 minus Placebo) were estimated using an analysis of covariance (ANCOVA) model fitting treatment and Baseline amount of hours spent ON/OFF as main effects.|ON: Treatment Period||3.48|0.28|
70998961|NCT01602549|141505191|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-2.83|||||TWO_SIDED|95.0|-21.79|16.13|||||Day 1, pre-dose: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|Pre-dose: Day GSK962040 50 mg Vs Placebo Day 1||16.13|-21.79|
71041723|NCT00407745|141592591|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.23||0.0004|TWO_SIDED|95.0|-1.26|-0.36||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 5~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.36|-1.26|0.0004
71041724|NCT00407745|141592591|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.23||0.0018|TWO_SIDED|95.0|-1.17|-0.27||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 6~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.27|-1.17|0.0018
71041725|NCT00407745|141592591|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.23||0.0027|TWO_SIDED|95.0|-1.14|-0.24||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 7~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.24|-1.14|0.0027
71041726|NCT00407745|141592591|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.23||0.0041|TWO_SIDED|95.0|-1.11|-0.21||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 8~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.21|-1.11|0.0041
70998962|NCT01602549|141505191|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|0.58|||||TWO_SIDED|95.0|-18.39|19.56|||||Day 1, 0 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|0 min PD: GSK962040 50 mg Vs Placebo Day 1||19.56|-18.39|
70998963|NCT01602549|141505191|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|1.84|||||TWO_SIDED|95.0|-17.18|20.86|||||Day 1, 30 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|Day 1, 30 min PD||20.86|-17.18|
70998964|NCT01602549|141505191|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|0.28|||||TWO_SIDED|95.0|-18.72|19.28|||||Day 1, 60 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|60 min PD: GSK962040 50 mg Vs Placebo Day 1||19.28|-18.72|
70998965|NCT01602549|141505191|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.38|||||TWO_SIDED|95.0|-22.35|15.58|||||Day 1, 90 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|90 min PD: GSK962040 50 mg Vs Placebo Day 1||15.58|-22.35|
70998966|NCT01602549|141505191|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-4.18|||||TWO_SIDED|95.0|-23.13|14.76|||||Day 1, 120 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|120 min PD: GSK962040 50 mg Vs Placebo Day 1||14.76|-23.13|
70998967|NCT01602549|141505191|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-6.39|||||TWO_SIDED|95.0|-25.36|12.58|||||Day 1, 180 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|180 min PD: GSK962040 50 mg Vs Placebo Day 1||12.58|-25.36|
70998968|NCT01602549|141505191|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|0.77|||||TWO_SIDED|95.0|-18.2|19.75|||||Day 1, 240 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|240 min PD: GSK962040 50 mg Vs Placebo Day 1||19.75|-18.20|
71041727|NCT00407745|141592591|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.23||0.0058|TWO_SIDED|95.0|-1.09|-0.18||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 9~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.18|-1.09|0.0058
70998969|NCT01602549|141505191|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|0.51|||||TWO_SIDED|95.0|-18.51|19.52|||||Day 8, pre-dose: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|Pre-dose: GSK962040 50 mg Vs Placebo Day 8||19.52|-18.51|
70998970|NCT01602549|141505191|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|3.32|||||TWO_SIDED|95.0|-15.7|22.33|||||Day 8, 0 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|0 min PD: GSK962040 50 mg Vs Placebo Day 8||22.33|-15.70|
70998971|NCT01602549|141505191|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-2.94|||||TWO_SIDED|95.0|-21.97|16.08|||||Day 8, 30 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|30 min PD: GSK962040 50 mg Vs Placebo Day 8||16.08|-21.97|
70998972|NCT01602549|141505191|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.12|||||TWO_SIDED|95.0|-22.13|15.88|||||Day 8, 60 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|60 min PD: GSK962040 50 mg Vs Placebo Day 8||15.88|-22.13|
70998973|NCT01602549|141505191|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-1.38|||||TWO_SIDED|95.0|-20.4|17.63|||||Day 8, 90 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|90 min PD: GSK962040 50 mg Vs Placebo Day 8||17.63|-20.40|
70998974|NCT01602549|141505191|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-0.71|||||TWO_SIDED|95.0|-19.7|18.28|||||Day 8, 120 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|120 min PD: GSK962040 50 mg Vs Placebo Day 8||18.28|-19.70|
70998975|NCT01602549|141505191|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|3.02|||||TWO_SIDED|95.0|-15.98|22.02|||||Day 8, 180 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|180 min PD: GSK962040 50 mg Vs Placebo Day 8||22.02|-15.98|
70998976|NCT01602549|141505191|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|4.08|||||TWO_SIDED|95.0|-14.91|23.07|||||Day 8, 240 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|240 min PD: GSK962040 50 mg Vs Placebo Day 8||23.07|-14.91|
70998977|NCT00719862|141505213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05|STANDARD_DEVIATION|0.3782||0.005||95.0|-1.8|-0.31|||ANOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.31|-1.80|0.005
70998978|NCT00719862|141505214|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.2987|STANDARD_DEVIATION|0.1881||0.112||95.0|-0.67|0.07|||ANOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||0.07|-0.67|0.112
70998979|NCT00719862|141505215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8617|STANDARD_DEVIATION|0.3803||0.023||95.0|-1.61|-0.12|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.12|-1.61|0.023
70998980|NCT00719862|141505216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7395|STANDARD_DEVIATION|0.3305||0.025||95.0|-1.39|-0.09|||ANOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline||-0.09|-1.39|0.025
70998981|NCT00719862|141505217|SUPERIORITY_OR_OTHER|||||||0.051|||||||ANOVA|||Change from baseline||||0.051
70998982|NCT02483078|141505234|SUPERIORITY|||||||0.0032|||||||Fisher Exact|The Fisher's Exact test if the count in any cell was less than 5; otherwise Chi-Square test was to be used||||||.0032
70998983|NCT02483078|141505235|SUPERIORITY|||||||0.0377|||||||Fisher Exact|||||||.0377
70998984|NCT02483078|141505236|SUPERIORITY|||||||0.1201|||||||Fisher Exact|||||||.1201
70998985|NCT02483078|141505237|SUPERIORITY|||||||0.0013|||||||ANCOVA|||||||.0013
70998986|NCT02483078|141505241|SUPERIORITY|||||||0.7123|||||||ANCOVA|||The raw and change from baseline in CD4 cell count at the end of the 1-week double blind treatment period was to be summarized by treatment group for the first week during the double-blind treatment phase. For change from baseline summaries, subjects with an undefined change from baseline, because of missing data, were to be excluded.||||.7123
70998987|NCT02483078|141505243|SUPERIORITY|||||||0.0993|||||||Fisher Exact|||||||.0993
70998988|NCT03366844|141505283|OTHER||Proportion|0.6|||||TWO_SIDED|95.0|0.465|0.724|||||95% confidence interval for one proportion were estimated using the Exact (Clopper-Pearson) method.|||0.724|0.465|
70998989|NCT00107172|141505289|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.01||||0.98|TWO_SIDED|95.0|0.51|1.98|||Log Rank|Competing risk P-value = 0.91.||The competing risk analysis accounting for death/regional and distant recurrence as competing events was performed.||1.98|0.51|0.98
70998990|NCT00107172|141505290|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.07||||0.75|TWO_SIDED|95.0|0.71|1.61|||Log Rank|||||1.61|0.71|0.75
70998991|NCT00107172|141505295|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|TWO_SIDED||||||Fisher Exact|||Compare the grade 3+ adverse events incidence reported from day 0 to 30 between arms.||||0.37
70998992|NCT00107172|141505295|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|TWO_SIDED||||||Fisher Exact|||Compare the grade 3+ adverse events incidence reported from day 0 to 90 between arms.||||0.25
70998993|NCT00107172|141505296|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35|TWO_SIDED||||||Fisher Exact|||Compare the grade 3+ respiratory adverse events incidence reported from day 0 to 30 between arms.||||0.35
70998994|NCT00107172|141505296|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31|TWO_SIDED||||||Fisher Exact|||Compare the grade 3+ respiratory adverse events incidence reported from day 0 to 90 between arms.||||0.31
70998995|NCT00107172|141505299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|TWO_SIDED||||||Wilcoxon Signed Rank|||Compare the percentage change from baseline to 3-month value for SR arm.||||0.03
70998996|NCT00107172|141505299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|TWO_SIDED||||||Wilcoxon Signed Rank|||Compare the percentage change from baseline to 3-month value for SR + BX arm.||||0.18
70998997|NCT00107172|141505300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.38|TWO_SIDED||||||Wilcoxon Signed Rank|||Compare the percentage change from baseline to 3-month value for SR arm.||||0.38
70998998|NCT00107172|141505300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|TWO_SIDED||||||Wilcoxon Signed Rank|||Compare the percentage change from baseline to 3-month value for SR + BX arm.||||0.16
70998999|NCT00789724|141505301|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||ANOVA|||||||0.033
70999000|NCT01673490|141505330|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
70999001|NCT01673490|141505331|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||for Month 3|t-test, 2 sided|||||||<0.001
70999002|NCT01673490|141505331|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||for Month 6|t-test, 2 sided|||||||<0.001
70999003|NCT00379236|141505333|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||ANCOVA|Screening pain score was the covariate; study center was modeled as a random effect while all other variables were modeled as fixed effects.||||||0.008
70999004|NCT00379236|141505334|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value is purely nominal|ANCOVA|||||||0.001
70999005|NCT00379236|141505335|SUPERIORITY_OR_OTHER|||||||0.202||95.0|||||Chi-squared|||||||0.202
70999006|NCT00379236|141505336|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Chi-squared|||||||0.047
70999007|NCT00379236|141505337|SUPERIORITY_OR_OTHER|||||||0.618||95.0|||||Chi-squared|||||||0.618
70999008|NCT00379236|141505338|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Chi-squared|||||||0.028
70999009|NCT00379236|141505339|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANCOVA|Baseline pain score was the covariate; study center was modeled as a random effect while all other variables were modeled as fixed effects.||||||0.002
70999010|NCT00379236|141505350|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Chi-squared|||||||0.006
70999011|NCT01783470|141505359|EQUIVALENCE|All p values presented are two tailed. p values \< 0.05 were considered to indicate statistical significance for the primary outcome.||||||0.001|||||||Wilcoxon sign-ranks test|||Since the sample size of twelve subjects limited the ability to demonstrate that measurements were normally distributed, we used the non-parametric Wilcoxon sign-ranks test to assess the primary and secondary endpoints. All p values presented are two tailed. p values \< 0.05 were considered to indicate statistical significance for the primary outcome.||||0.001
70999012|NCT01510834|141505361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.824|STANDARD_DEVIATION|14.148||0.001|TWO_SIDED|95.0|-10.578|-3.07|||t-test, 2 sided|||||-3.070|-10.578|.001
70999013|NCT01510834|141505362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0872|STANDARD_DEVIATION|15.731||0.001|TWO_SIDED|95.0|2.91|11.26|||t-test, 2 sided|||||11.26|2.91|.001
71041728|NCT00407745|141592591|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.23||0.0031|TWO_SIDED|95.0|-1.14|-0.23||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 10~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.23|-1.14|0.0031
71041729|NCT00407745|141592591|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.23||0.0076|TWO_SIDED|95.0|-1.08|-0.17||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 11~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.17|-1.08|0.0076
71041730|NCT00407745|141592591|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.23||0.0328|TWO_SIDED|95.0|-0.95|-0.04||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 12~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.04|-0.95|0.0328
71041731|NCT00407745|141592591|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.23||0.015|TWO_SIDED|95.0|-1.02|-0.11||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 13~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.11|-1.02|0.0150
71041732|NCT00407745|141592591|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.23||0.0048|TWO_SIDED|95.0|-1.11|-0.2||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 14~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.20|-1.11|0.0048
71041733|NCT00407745|141592591|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.23||0.003|TWO_SIDED|95.0|-1.15|-0.24||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 15~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.24|-1.15|0.0030
71041734|NCT00407745|141592591|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.23||0.0011|TWO_SIDED|95.0|-1.22|-0.3||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 16~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.30|-1.22|0.0011
71041735|NCT00407745|141592592|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.24||||0.0256|TWO_SIDED|95.0|1.103|4.546||Significance was declared if p-value \<=0.05|Regression, Logistic|Logistic regression used terms for treatment, baseline pain score as covariate, baseline PCS total score, and pooled center as cofactor.||Null hypothesis - The rate of responder for the pregabain group was equal to the rate of responder for the placebo group; Alternative hypothesis - The rate of responder for the pregabain group was not equal to the rate of responder for the placebo group.||4.546|1.103|0.0256
71041736|NCT00407745|141592593|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.22||0.0004|TWO_SIDED|95.0|-1.23|-0.35||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 1.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.35|-1.23|0.0004
71041737|NCT00407745|141592593|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.31|-0.43||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week2~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.43|-1.31|<0.0001
71041738|NCT00407745|141592593|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.22||0.0004|TWO_SIDED|95.0|-1.24|-0.36||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 3.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.36|-1.24|0.0004
71041739|NCT00407745|141592593|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.23||0.0008|TWO_SIDED|95.0|-1.2|-0.32||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 4.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.32|-1.20|0.0008
71041740|NCT00407745|141592593|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.94|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.38|-0.49||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 5.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.49|-1.38|<0.0001
71041741|NCT00407745|141592593|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.93|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.37|-0.48||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 6.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.48|-1.37|<0.0001
71041742|NCT00407745|141592593|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.91|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.35|-0.47||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 7.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.47|-1.35|<0.0001
71041743|NCT00407745|141592593|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.35|-0.46||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 8.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.46|-1.35|<0.0001
71041744|NCT00407745|141592593|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.94|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.39|-0.5||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 9.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.50|-1.39|<0.0001
71100388|NCT03707821|141709571|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores. Non-inferiority was declared in the lower limit of the 95% credible interval was above 5.|Mean Difference (Net)|2.5|STANDARD_DEVIATION|1.94|||TWO_SIDED|95.0|-1.3|6.3|||Bayesian normal random-effects|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test minus Control.|Sample Size was based on primary endpoints only.||6.3|-1.3|
71100389|NCT03707821|141709572|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores. Non-inferiority was declared in the lower limit of the 95% credible interval was above 5.|Mean Difference (Net)|8.03|STANDARD_DEVIATION|2.295|||TWO_SIDED|95.0|3.48|12.54|||Bayesian normal random-effects|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test minus Control.|Sample Size was based on primary endpoints only.||12.54|3.48|
71041745|NCT00407745|141592593|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.08|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.53|-0.63||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 10.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.63|-1.53|<0.0001
71041746|NCT00407745|141592593|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.94|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.39|-0.49||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 11.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.49|-1.39|<0.0001
71100390|NCT05122143|141709573|SUPERIORITY|||||||0.0085||||||Treatment D (A+B) versus Treatment C|ANCOVA|||"Treatment A + B were pooled to Treatment D for the Primary endpoint. The primary objective was to compare the efficacy of the AM-301 nasal spray (treatment D= A+B) and no treatment (C) in reducing nasal symptoms induced from HDM allergen exposure.~The TNSS value from the baseline exposure (at screening exposure visit 2) was subtracted from the TNSS value of the treatment exposure to obtain change from baseline. A lower value resembles less symptoms."||||0.0085
71041747|NCT00407745|141592593|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.92|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.37|-0.47||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 12.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.47|-1.37|<0.0001
71100391|NCT03766906|141709575|SUPERIORITY||Mean Difference (Final Values)|2.03||||0.003|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pretest to posttest change was significantly greater than 0 at P \< 0.05.|||||.003
71100392|NCT03766906|141709576|SUPERIORITY||Mean Difference (Final Values)|1.18||||0.022|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pre-test to post-test change was significantly greater than zero at P\<0.05.|||||.022
71100393|NCT03766906|141709577|SUPERIORITY||Mean Difference (Final Values)|1.34||||0.016|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|||||.016
71100394|NCT03766906|141709578|SUPERIORITY||Mean Difference (Final Values)|0.95||||0.002|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|||||.002
71100395|NCT03766906|141709579|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.626|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|The statistical analyses for the Student Self-Efficacy, in terms of type of statistical test, method, and the comments which we state within-subjects paired t-tests, are the same for each of the three subscales that make up Student Self-Efficacy (i.e., Relevance to schoolwork, Future aspirations, and Family support).||||.626
71100396|NCT03766906|141709579|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.909|TWO_SIDED||||||t-test, 2 sided|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.||The statistical analyses for the Student Self-Efficacy, in terms of type of statistical test, method, and the comments which we state within-subjects paired t-tests, are the same for each of the three subscales that make up Student Self-Efficacy (i.e., Relevance to schoolwork, Future aspirations, and Family support).||||.909
71100397|NCT03766906|141709579|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.905|TWO_SIDED||||||t-test, 2 sided||Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|The statistical analyses for the Student Self-Efficacy, in terms of type of statistical test, method, and the comments which we state within-subjects paired t-tests, are the same for each of the three subscales that make up Student Self-Efficacy (i.e., Relevance to schoolwork, Future aspirations, and Family support).||||.905
71100398|NCT03766906|141709580|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.054|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|||||.054
71100399|NCT03766906|141709581|SUPERIORITY||Mean Difference (Final Values)|3.48|||<|0.001|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|||||<.001
71100400|NCT03766906|141709582|SUPERIORITY||Mean Difference (Final Values)|7.52|||<|0.001|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|||||<.001
71041748|NCT00407745|141592593|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.92|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.38|-0.47||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 13.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.47|-1.38|<0.0001
71100401|NCT01651208|141709614|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED|95.0|||||Chi-squared|||We hypothesized that in the MINT group, at least 70% of subjects will reach an MPR of 0.80 while in the DVD group, the proportion will remain at or below 55%. Our sample size estimates showed that, using a conservative 2-sided test at the 5% Alpha level and a 90% power, we will be able to detect a significant 15% difference (70% - 55%) with a sample of 217 in each study group.||||<0.01
71041749|NCT00407745|141592593|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.96|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.41|-0.51||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 14.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.51|-1.41|<0.0001
71100402|NCT01651208|141709615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis is that the mean MMAS-4 score is similar in both intervention arms||||<0.01
71100403|NCT00836901|141709616|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|97.7||||||90.0|93.19|102.43|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||102.43|93.19|
71100404|NCT00836901|141709617|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|99.28||||||90.0|97.09|101.53|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.53|97.09|
71100405|NCT00836901|141709618|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|97.64||||||90.0|96.12|99.19|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||99.19|96.12|
71041750|NCT00407745|141592593|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.08|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.53|-0.63||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 15.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.63|-1.53|<0.0001
71100406|NCT00836901|141709619|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|94.59||||||90.0|85.64|104.47|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.47|85.64|
71100407|NCT00836901|141709620|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|94.44||||||90.0|87.83|101.54|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.54|87.83|
71100408|NCT00836901|141709621|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|94.08||||||90.0|87.19|101.52|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.52|87.19|
71100409|NCT02732145|141709659|OTHER|"Question: Determination of sensitivity of the Vulvoscopy Index as a measure of the sensitivity of Three Rings Vulvoscopy in comparison to the histopathological diagnosis of vulvar dermatosis."|Sensitivity (2x2 Table)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||"The Sensitivity of the Vulvoscopy Index for Detection of Vulvar Dermatosis was 1.000 (Range: 1.0000 - 1.0000)."|"Parameter: Sensitivity of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|1.0000|
71100410|NCT02732145|141709659|OTHER|"Question: Determination of specificity of the Vulvoscopy index as a measure of the specificity of Three Rings Vulvoscopy in comparison to the histopathological diagnosis of vulvar dermatosis."|Specificity (2x2 Table)|0.9609|||||TWO_SIDED|95.0|0.5794|1.0|||||"The Specificity of the Vulvoscopy Index for Detection of Vulvar Dermatosis was 0.9609 (Range: 0.5794 - 1.0000)"|"Parameter: Specificity of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|0.5794|
71100411|NCT02732145|141709659|OTHER|"Question: Determination of diagnostic accuracy of the Vulvoscopy index as a measure of the diagnostic value of Three Rings Vulvoscopy in comparison to the histopathological diagnosis of vulvar dermatosis."|Diagnostic Accuracy (2x2 Table)|0.9695|||||TWO_SIDED|95.0|0.6313|1.0|||||"The Diagnostic accuracy of the Vulvoscopy Index for Detection of Vulvar Dermatosis was 0.9695 (Range: 0.6313 - 1.0000)"|"Parameter: Diagnostic accuracy of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|0.6313|
71100412|NCT02732145|141709659|SUPERIORITY|"Question: Determination of positive predictive value of the Vulvoscopy index for detection of vulvar dermatosis in comparison to the histopathology results."|PPV (2x2 Table)|0.878|||||TWO_SIDED|95.0|0.227|1.0|||||"Positive predictive value of the Vulvoscopy Index for Detection of Vulvar Dermatosis was 0.8780 (Range: 0.2270 - 1.0000)."|"Parameter: Positive predictive value of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|0.2270|
71100413|NCT02732145|141709659|OTHER|"Question: Determination of negative predictive value of the Vulvoscopy index for detection of vulvar dermatosis in comparison to the histopathology results."|NPV (2x2 Table)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||"Negative predictive value of the Vulvoscopy Index for Detection of Vulvar Dermatosis was 1.0000 (Range: 1.0000 - 1.0000)."|"Parameter: Negative predictive value of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|1.0000|
71100414|NCT02732145|141709659|SUPERIORITY|"Question: Is there a difference in the diagnostic accuracy of the Vulvoscopy Index as an outcome measure of the diagnostic value of Three Rings Vulvoscopy, and histopathology?"||||||0.6108|||||||t-test proportion|||"Parameter: The difference in the diagnostic accuracy between TRIV using the Vulvoscopy Index and histopathology for detection of vulvar dermatosis."||||0.6108
71041751|NCT00407745|141592593|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.06|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.51|-0.61||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 16.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.61|-1.51|<0.0001
71041752|NCT00407745|141592594|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.269||0.0438|TWO_SIDED|95.0|-1.08|-0.02||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline mBPI-10 Total Score as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-0.02|-1.08|0.0438
71041753|NCT00407745|141592595|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.448||0.7103|TWO_SIDED|95.0|-1.06|0.72||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Static Mechanical Allodynia as a covariate and pooled center and treatment as fixed (class) cofactors.||"At/above level: within 2 dermatomes above or below the neurological level of injury (NLI).~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.72|-1.06|0.7103
71041754|NCT00407745|141592595|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.34||0.0747|TWO_SIDED|95.0|-1.28|0.06||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Static Mechanical Allodynia as a covariate and pooled center and treatment as fixed (class) cofactors.||"Below level: more than 2 dermatomes below the NLI.~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.06|-1.28|0.0747
71041755|NCT00407745|141592596|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.379||0.5689|TWO_SIDED|95.0|-0.97|0.54||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Dynamic Mechanical Allodynia as covariate and pooled center and treatment as fixed (class) cofactors.||"At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.54|-0.97|0.5689
71041756|NCT00407745|141592596|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.322||0.4764|TWO_SIDED|95.0|-0.87|0.41||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Dynamic Mechanical Allodynia as covariate and pooled center and treatment as fixed (class) cofactors.||"Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.41|-0.87|0.4764
71041757|NCT00407745|141592597|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.474||0.3362|TWO_SIDED|95.0|-1.4|0.48||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Punctate Hyperalgesia as a covariate and pooled center and treatment as fixed (class) cofactors.||"At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.48|-1.40|0.3362
71041758|NCT00407745|141592597|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.321||0.3113|TWO_SIDED|95.0|-0.96|0.31||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Punctate Hyperalgesia as a covariate and pooled center and treatment as fixed (class) cofactors.||"Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.31|-0.96|0.3113
71041759|NCT00407745|141592598|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.539||0.2721|TWO_SIDED|95.0|-1.67|0.48||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Temporal Summation to stimuli as covariate and pooled center and treatment as fixed (class) cofactors.||"At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.48|-1.67|0.2721
71041760|NCT00407745|141592598|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.337||0.4906|TWO_SIDED|95.0|-0.43|0.9||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Temporal Summation to stimuli as covariate and pooled center and treatment as fixed (class) cofactors.||"Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.90|-0.43|0.4906
71041761|NCT00407745|141592599|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.472||0.3123|TWO_SIDED|95.0|-1.42|0.46||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Cold Allodynia as a covariate and pooled center and treatment as fixed (class) cofactors.||"At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.46|-1.42|0.3123
71100415|NCT02732145|141709660|SUPERIORITY|Question: Is there a difference in the frequency of vulvar complaints among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||t-test proportion|||Parameter: The difference in the frequency of vulvar complaints in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
70999014|NCT01510834|141505363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.78|STANDARD_DEVIATION|7.78|<|0.001|TWO_SIDED|95.0|-5.84|-1.7|||t-test, 2 sided|||||-1.70|-5.84|<.001
70999015|NCT01510834|141505364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.08|STANDARD_DEVIATION|6.269||0.015|TWO_SIDED|95.0|-3.751|-0.4244|||t-test, 2 sided|||||-.4244|-3.751|.015
70999016|NCT00527072|141505380|SUPERIORITY_OR_OTHER||Proportion|0.654||||0.05|TWO_SIDED|95.0|0.586|0.718|||exact binomial distribution|||null hypothesis H0: proportion = 0.30||0.718|0.586|0.05
71041762|NCT00407745|141592599|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.368||0.136|TWO_SIDED|95.0|-1.28|0.18||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Cold Allodynia as a covariate and pooled center and treatment as fixed (class) cofactors.||"Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.18|-1.28|0.1360
71041763|NCT00407745|141592600|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.549||0.4257|TWO_SIDED|95.0|-1.53|0.65||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Cold Hyperalgesia Subscales as a covariate and pooled center and treatment as fixed (class) cofactors.||"At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.65|-1.53|0.4257
71041764|NCT00407745|141592600|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.412||0.2005|TWO_SIDED|95.0|-1.34|0.28||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Cold Hyperalgesia Subscales as a covariate and pooled center and treatment as fixed (class) cofactors.||"Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.28|-1.34|0.2005
71041765|NCT00407745|141592601|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.025||0.1377|TWO_SIDED|95.0|-0.09|0.01||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - 12 Items Total Intensity Score as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.01|-0.09|0.1377
71041766|NCT00407745|141592602|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.038||0.3312|TWO_SIDED|95.0|-0.11|0.04||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Burning Spontaneous Pain as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.04|-0.11|0.3312
71041767|NCT00407745|141592603|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.033||0.044|TWO_SIDED|95.0|-0.13|0.0||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Pressing Spontaneous Pain as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.00|-0.13|0.0440
71041768|NCT00407745|141592604|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.033||0.137|TWO_SIDED|95.0|-0.12|0.02||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Paroxysmal Pain as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.02|-0.12|0.1370
71100416|NCT02732145|141709660|SUPERIORITY|Question: Is there a difference in the frequency of positive Marinoff Index among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9628|||||||t-test proportion|||Parameter: The difference in the frequency of positive Marinoff Index in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9628
71100417|NCT02732145|141709660|SUPERIORITY|Question: Is there a difference in the frequency of the positive Cotton-Swab test among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9152|||||||t-test proportion|||Parameter: The difference in the frequency of the positive Cotton-Swab test in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9152
71100418|NCT02732145|141709660|SUPERIORITY|Question: Is there a difference in the frequency of any lesion in any vulvar ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||t-test proportion|||Parameter: The difference in the frequency of any lesion in any vulvar ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
70999017|NCT00527072|141505381|SUPERIORITY_OR_OTHER||proportion|0.791||||0.05|TWO_SIDED|95.0|0.73|0.844|||exact binomial distribution|||||0.844|0.730|0.05
70999018|NCT00527072|141505382|SUPERIORITY_OR_OTHER||proportion|0.646||||0.05|TWO_SIDED|95.0|0.577|0.711|||exact binomial distribution|||||0.711|0.577|0.05
70999019|NCT00810043|141505383|SUPERIORITY_OR_OTHER|||||||0.43|||||||t-test, 2 sided|||Anterior vertebral body height restoration as a percent (Post-procedure change from baseline)||||0.430
70999020|NCT00810043|141505383|SUPERIORITY_OR_OTHER|||||||0.643|||||||t-test, 2 sided|||Middle vertebral body height restoration as a percent (Post-procedure change from baseline)||||0.643
70999021|NCT00810043|141505383|SUPERIORITY_OR_OTHER|||||||0.165|||||||t-test, 2 sided|||Posterior vertebral body height restoration as a percent (Post-procedure change from baseline)||||0.165
70999022|NCT00810043|141505384|SUPERIORITY_OR_OTHER|||||||0.402|||||||t-test, 2 sided|||Anterior VBH restored||||0.402
70999023|NCT00810043|141505384|SUPERIORITY_OR_OTHER|||||||0.578|||||||t-test, 2 sided|||Middle VBH restored||||0.578
70999024|NCT00810043|141505384|SUPERIORITY_OR_OTHER|||||||0.166|||||||t-test, 2 sided|||Posterior VBH restored||||0.166
71100419|NCT02732145|141709660|SUPERIORITY|Question: Is there a difference in the frequency of any vulvar lesion of the Outer Vulvar Ring among the patients with vulvar dermatosis diagnosed with vulvoscopy and histopathology?||||||0.8862|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8862
70999025|NCT00810043|141505386|SUPERIORITY_OR_OTHER|||||||0.9|||||||t-test, 2 sided|||Anterior VBH gained by postural reduction||||0.900
70999026|NCT00810043|141505386|SUPERIORITY_OR_OTHER|||||||0.62|||||||t-test, 2 sided|||Middle VBH gained by postural reduction||||0.620
70999027|NCT00810043|141505386|SUPERIORITY_OR_OTHER|||||||0.349|||||||t-test, 2 sided|||Posterior VBH gained by postural reduction||||0.349
70999028|NCT00810043|141505387|SUPERIORITY_OR_OTHER|||||||0.889|||||||t-test, 2 sided|||||||0.889
70999029|NCT00810043|141505388|SUPERIORITY_OR_OTHER|||||||0.486|||||||t-test, 2 sided|||||||0.486
70999030|NCT00810043|141505389|SUPERIORITY_OR_OTHER|||||||0.144|||||||t-test, 2 sided|||||||0.144
70999031|NCT00810043|141505390|SUPERIORITY_OR_OTHER|||||||0.36|||||||Chi-squared|||||||0.360
70999032|NCT01989754|141505391|SUPERIORITY||Hazard Ratio (HR)|0.64|||<|0.0001|TWO_SIDED|95.0|0.57|0.73|||Cox proportional hazard method|||||0.73|0.57|<.0001
70999033|NCT01989754|141505392|SUPERIORITY||Hazard Ratio (HR)|0.72|||=|0.0148|TWO_SIDED|95.0|0.55|0.94|||Stratified Cox proportional hazard|||||0.94|0.55|=0.0148
71100420|NCT02732145|141709660|SUPERIORITY|Question: Is there a difference in the frequency of any vulvar lesion of the Middle Vulvar Ring among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
70999034|NCT01989754|141505393|SUPERIORITY||Hazard Ratio (HR)|0.86|||=|0.4067|TWO_SIDED|95.0|0.61|1.22|||Stratified Cox proportional hazard|||||1.22|0.61|=0.4067
70999035|NCT03364491|141505400|SUPERIORITY|Model included treatment and preoperative hemoglobin level \<8 g/dL (yes/no) as covariates. We estimated that a total sample size of 11,000 participants (5,500 per group) would achieve 85% power to detect a 33% lower incidence of the primary outcome (1.67%) in the TXA group, at a type I error rate (two-sided) of 5%.|Risk Ratio (RR)|0.89||||0.19|TWO_SIDED|95.26|0.74|1.07||Following two interim analyses, a two-tailed P value of less than 0.047 was considered to indicate statistical significance.|Other (Log-binomial regression model)|||||1.07|0.74|0.19
70999036|NCT02980692|141505428|SUPERIORITY|||||||0.0001|||||||Cochran-Mantel-Haenszel|||||||0.0001
70999037|NCT02980692|141505428|SUPERIORITY|||||||0.0006|||||||Cochran-Mantel-Haenszel|||||||0.0006
70999038|NCT02980692|141505428|SUPERIORITY|||||||0.0088|||||||Cochran-Mantel-Haenszel|||||||0.0088
70999039|NCT02980692|141505428|SUPERIORITY|||||||0.0041|||||||Cochran-Mantel-Haenszel|||||||0.0041
70999040|NCT02980692|141505429|SUPERIORITY||% response rate|92.54|STANDARD_ERROR_OF_MEAN|3.21|||TWO_SIDED|95.0|86.24|98.83||||||||98.83|86.24|
70999041|NCT02980692|141505429|SUPERIORITY||% response rate|89.06|STANDARD_ERROR_OF_MEAN|3.9|||TWO_SIDED|95.0|81.42|96.71||||||||96.71|81.42|
70999042|NCT02980692|141505429|SUPERIORITY||% response rate|86.67|STANDARD_ERROR_OF_MEAN|4.39|||TWO_SIDED|95.0|78.07|95.27||||||||95.27|78.07|
70999043|NCT02980692|141505429|SUPERIORITY||% response rate|81.33|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|72.52|90.15||||||||90.15|72.52|
70999044|NCT02980692|141505429|SUPERIORITY||% response rate|81.33|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|72.52|90.15||||||||90.15|72.52|
70999045|NCT02980692|141505430|SUPERIORITY||% response rate|79.1|STANDARD_ERROR_OF_MEAN|4.97|||TWO_SIDED|95.0|69.37|88.84||||||||88.84|69.37|
70999046|NCT02980692|141505430|SUPERIORITY||% response rate|75.0|STANDARD_ERROR_OF_MEAN|5.41|||TWO_SIDED|95.0|64.39|85.61||||||||85.61|64.39|
70999047|NCT02980692|141505430|SUPERIORITY||% response rate|72.13|STANDARD_ERROR_OF_MEAN|5.74|||TWO_SIDED|95.0|60.88|83.38||||||||83.38|60.88|
70999048|NCT02980692|141505430|SUPERIORITY||% response rate|68.0|STANDARD_ERROR_OF_MEAN|5.39|||TWO_SIDED|95.0|57.44|78.56||||||||78.56|57.44|
70999049|NCT02980692|141505430|SUPERIORITY||% response rate|62.67|STANDARD_ERROR_OF_MEAN|5.59|||TWO_SIDED|95.0|51.72|73.61||||||||73.61|51.72|
70999050|NCT02980692|141505431|SUPERIORITY||% response rate|58.21|STANDARD_ERROR_OF_MEAN|6.03|||TWO_SIDED|95.0|46.4|70.02||||||||70.02|46.40|
70999051|NCT02980692|141505431|SUPERIORITY||% response rate|48.44|STANDARD_ERROR_OF_MEAN|6.25|||TWO_SIDED|95.0|36.19|60.68||||||||60.68|36.19|
70999052|NCT02980692|141505431|SUPERIORITY||% response rate|39.34|STANDARD_ERROR_OF_MEAN|6.25|||TWO_SIDED|95.0|27.09|51.6||||||||51.60|27.09|
70999053|NCT02980692|141505431|SUPERIORITY||% response rate|40.0|STANDARD_ERROR_OF_MEAN|5.66|||TWO_SIDED|95.0|28.91|51.09||||||||51.09|28.91|
70999054|NCT02980692|141505431|SUPERIORITY||% response rate|37.33|STANDARD_ERROR_OF_MEAN|5.59|||TWO_SIDED|95.0|26.39|48.28||||||||48.28|26.39|
70999055|NCT02980692|141505432|SUPERIORITY|||||||0.085|||||||Cochran-Mantel-Haenszel|||||||0.0850
70999056|NCT02980692|141505432|SUPERIORITY|||||||0.0234|||||||Cochran-Mantel-Haenszel|||||||0.0234
70999057|NCT02980692|141505432|SUPERIORITY|||||||0.014|||||||Cochran-Mantel-Haenszel|||||||0.0140
70999058|NCT02980692|141505432|SUPERIORITY|||||||0.0731|||||||Cochran-Mantel-Haenszel|||||||0.0731
70999059|NCT02980692|141505433|SUPERIORITY||Mean Difference (Net)|-12.3|STANDARD_DEVIATION|11.47|||TWO_SIDED|||||||||||||
70999060|NCT02980692|141505433|SUPERIORITY||Mean Difference (Net)|-13.7|STANDARD_DEVIATION|11.92|||TWO_SIDED|||||||||||||
70999061|NCT02980692|141505433|SUPERIORITY||Mean Difference (Net)|-16.0|STANDARD_DEVIATION|12.83|||TWO_SIDED|||||||||||||
70999062|NCT02980692|141505433|SUPERIORITY||Mean Difference (Net)|-14.0|STANDARD_DEVIATION|10.65|||TWO_SIDED|||||||||||||
70999063|NCT02980692|141505433|SUPERIORITY||Mean Difference (Net)|-13.9|STANDARD_DEVIATION|12.02|||TWO_SIDED|||||||||||||
70999064|NCT02980692|141505434|SUPERIORITY|||||||0.0111|||||||Cochran-Mantel-Haenszel|||||||0.0111
70999065|NCT02980692|141505434|SUPERIORITY|||||||0.0774|||||||Cochran-Mantel-Haenszel|||||||0.0774
70999066|NCT02980692|141505434|SUPERIORITY|||||||0.019|||||||Cochran-Mantel-Haenszel|||||||0.0190
70999067|NCT02980692|141505434|SUPERIORITY|||||||0.1282|||||||Cochran-Mantel-Haenszel|||||||0.1282
71100421|NCT02732145|141709660|SUPERIORITY|Question: Is there a difference in the frequency of any vulvar lesion of the Inner Vulvar Ring among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.3319|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.3319
70999068|NCT02980692|141505435|SUPERIORITY||Mean Difference (Net)|-8.7|STANDARD_DEVIATION|6.88|||TWO_SIDED|||||||||||||
70999069|NCT02980692|141505435|SUPERIORITY||Mean Difference (Net)|-7.5|STANDARD_DEVIATION|7.07|||TWO_SIDED|||||||||||||
70999070|NCT02980692|141505435|SUPERIORITY||Mean Difference (Net)|-9.2|STANDARD_DEVIATION|7.62|||TWO_SIDED|||||||||||||
70999071|NCT02980692|141505435|SUPERIORITY||Mean Difference (Net)|-7.5|STANDARD_DEVIATION|5.78|||TWO_SIDED|||||||||||||
70999072|NCT02980692|141505435|SUPERIORITY||Mean Difference (Net)|-9.0|STANDARD_DEVIATION|8.8|||TWO_SIDED|||||||||||||
70999073|NCT02980692|141505436|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<.0001
70999074|NCT02980692|141505436|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<.0001
70999075|NCT02980692|141505436|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<.0001
70999076|NCT02980692|141505436|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<.0001
70999077|NCT02980692|141505437|SUPERIORITY||Mean Difference (Net)|-40.0|STANDARD_DEVIATION|17.38|||TWO_SIDED|||||||||||||
70999078|NCT02980692|141505437|SUPERIORITY||Mean Difference (Net)|-44.3|STANDARD_DEVIATION|19.73|||TWO_SIDED|||||||||||||
70999079|NCT02980692|141505437|SUPERIORITY||Mean Difference (Net)|-45.3|STANDARD_DEVIATION|19.84|||TWO_SIDED|||||||||||||
70999080|NCT02980692|141505437|SUPERIORITY||Mean Difference (Net)|-42.7|STANDARD_DEVIATION|19.18|||TWO_SIDED|||||||||||||
70999081|NCT02980692|141505437|SUPERIORITY||Mean Difference (Net)|-42.0|STANDARD_DEVIATION|20.41|||TWO_SIDED|||||||||||||
70999082|NCT02980692|141505438|SUPERIORITY|||||||0.0003|||||||Cochran-Mantel-Haenszel|||||||0.0003
70999083|NCT02980692|141505438|SUPERIORITY|||||||0.0012|||||||Cochran-Mantel-Haenszel|||||||0.0012
70999084|NCT02980692|141505438|SUPERIORITY|||||||0.0011|||||||Cochran-Mantel-Haenszel|||||||0.0011
70999085|NCT02980692|141505438|SUPERIORITY|||||||0.0167|||||||Cochran-Mantel-Haenszel|||||||0.0167
70999086|NCT02980692|141505439|SUPERIORITY||Mean Difference (Net)|-42.2|STANDARD_DEVIATION|22.74|||TWO_SIDED|||||||||||||
70999087|NCT02980692|141505439|SUPERIORITY||Mean Difference (Net)|-43.8|STANDARD_DEVIATION|24.01|||TWO_SIDED|||||||||||||
70999088|NCT02980692|141505439|SUPERIORITY||Mean Difference (Net)|-38.4|STANDARD_DEVIATION|27.9|||TWO_SIDED|||||||||||||
70999089|NCT02980692|141505439|SUPERIORITY||Mean Difference (Net)|-37.9|STANDARD_DEVIATION|24.65|||TWO_SIDED|||||||||||||
70999090|NCT02980692|141505439|SUPERIORITY||Mean Difference (Net)|-40.5|STANDARD_DEVIATION|28.13|||TWO_SIDED|||||||||||||
70999091|NCT02980692|141505440|SUPERIORITY|||||||0.0003|||||||Cochran-Mantel-Haenszel|||||||0.0003
70999092|NCT02980692|141505440|SUPERIORITY|||||||0.0055|||||||Cochran-Mantel-Haenszel|||||||0.0055
70999093|NCT02980692|141505440|SUPERIORITY|||||||0.0039|||||||Cochran-Mantel-Haenszel|||||||0.0039
70999094|NCT02980692|141505440|SUPERIORITY|||||||0.0487|||||||Cochran-Mantel-Haenszel|||||||0.0487
70999095|NCT02980692|141505441|SUPERIORITY||Mean Difference (Net)|-40.7|STANDARD_DEVIATION|21.59|||TWO_SIDED|||||||||||||
70999096|NCT02980692|141505441|SUPERIORITY||Mean Difference (Net)|-42.7|STANDARD_DEVIATION|25.67|||TWO_SIDED|||||||||||||
70999097|NCT02980692|141505441|SUPERIORITY||Mean Difference (Net)|-38.0|STANDARD_DEVIATION|29.26|||TWO_SIDED|||||||||||||
70999098|NCT02980692|141505441|SUPERIORITY||Mean Difference (Net)|-37.6|STANDARD_DEVIATION|26.63|||TWO_SIDED|||||||||||||
70999099|NCT02980692|141505441|SUPERIORITY||Mean Difference (Net)|-41.0|STANDARD_DEVIATION|29.83|||TWO_SIDED|||||||||||||
70999100|NCT02980692|141505442|SUPERIORITY|||||||0.0987|||||||Cochran-Mantel-Haenszel|||||||0.0987
70999101|NCT02980692|141505442|SUPERIORITY|||||||0.036|||||||Cochran-Mantel-Haenszel|||||||0.0360
70999102|NCT02980692|141505442|SUPERIORITY|||||||0.0346|||||||Cochran-Mantel-Haenszel|||||||0.0346
70999103|NCT02980692|141505442|SUPERIORITY|||||||0.4442|||||||Cochran-Mantel-Haenszel|||||||0.4442
70999104|NCT02980692|141505443|SUPERIORITY||Mean Difference (Net)|-0.4869|STANDARD_DEVIATION|0.52093|||TWO_SIDED|||||||||||||
70999105|NCT02980692|141505443|SUPERIORITY||Mean Difference (Net)|-0.543|STANDARD_DEVIATION|0.59145|||TWO_SIDED|||||||||||||
70999106|NCT02980692|141505443|SUPERIORITY||Mean Difference (Net)|-0.4857|STANDARD_DEVIATION|0.56968|||TWO_SIDED|||||||||||||
70999107|NCT02980692|141505443|SUPERIORITY||Mean Difference (Net)|-0.4583|STANDARD_DEVIATION|0.52285|||TWO_SIDED|||||||||||||
70999108|NCT02980692|141505443|SUPERIORITY||Mean Difference (Net)|-0.47|STANDARD_DEVIATION|0.54013|||TWO_SIDED|||||||||||||
70999109|NCT02980692|141505444|SUPERIORITY|||||||0.0064|||||||Cochran-Mantel-Haenszel|||||||0.0064
70999110|NCT02980692|141505444|SUPERIORITY|||||||0.0516|||||||Cochran-Mantel-Haenszel|||||||0.0516
70999111|NCT02980692|141505444|SUPERIORITY|||||||0.0114|||||||Cochran-Mantel-Haenszel|||||||0.0114
70999112|NCT02980692|141505444|SUPERIORITY|||||||0.082|||||||Cochran-Mantel-Haenszel|||||||0.0820
70999113|NCT02980692|141505445|SUPERIORITY||Mean Difference (Net)|-3.43|STANDARD_DEVIATION|12.506|||TWO_SIDED|||||||||||||
70999114|NCT02980692|141505445|SUPERIORITY||Mean Difference (Net)|-3.68|STANDARD_DEVIATION|10.77|||TWO_SIDED|||||||||||||
70999115|NCT02980692|141505445|SUPERIORITY||Mean Difference (Net)|-6.05|STANDARD_DEVIATION|19.004|||TWO_SIDED|||||||||||||
70999116|NCT02980692|141505445|SUPERIORITY||Mean Difference (Net)|-4.61|STANDARD_DEVIATION|9.508|||TWO_SIDED|||||||||||||
70999117|NCT02980692|141505445|SUPERIORITY||Mean Difference (Net)|-6.75|STANDARD_DEVIATION|19.649|||TWO_SIDED|||||||||||||
70999118|NCT02980692|141505446|SUPERIORITY|||||||0.0351|||||||Cochran-Mantel-Haenszel|||||||0.0351
71041769|NCT00407745|141592605|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.028||0.8911|TWO_SIDED|95.0|-0.06|0.05||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Evoked pain as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.05|-0.06|0.8911
71041770|NCT00407745|141592606|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.034||0.3731|TWO_SIDED|95.0|-0.1|0.04||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Paresthesia/Dysesthesia as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.04|-0.10|0.3731
70999119|NCT02980692|141505446|SUPERIORITY|||||||0.0876|||||||Cochran-Mantel-Haenszel|||||||0.0876
70999120|NCT02980692|141505446|SUPERIORITY|||||||0.0269|||||||Cochran-Mantel-Haenszel|||||||0.0269
70999121|NCT02980692|141505446|SUPERIORITY|||||||0.0185|||||||Cochran-Mantel-Haenszel|||||||0.0185
70999122|NCT02980692|141505447|SUPERIORITY||Mean Difference (Net)|-7.2|STANDARD_DEVIATION|19.58|||TWO_SIDED|||||||||||||
70999123|NCT02980692|141505447|SUPERIORITY||Mean Difference (Net)|-7.2|STANDARD_DEVIATION|15.26|||TWO_SIDED|||||||||||||
70999124|NCT02980692|141505447|SUPERIORITY||Median Difference (Net)|-8.9|STANDARD_DEVIATION|20.48|||TWO_SIDED|||||||||||||
70999125|NCT02980692|141505447|SUPERIORITY||Mean Difference (Net)|-9.7|STANDARD_DEVIATION|19.02|||TWO_SIDED|||||||||||||
70999126|NCT02980692|141505447|SUPERIORITY||Mean Difference (Net)|-9.2|STANDARD_DEVIATION|20.47|||TWO_SIDED|||||||||||||
70999127|NCT02980692|141505448|SUPERIORITY||Proportion with Adjustment of Background|1.27|STANDARD_ERROR_OF_MEAN|1.26|||TWO_SIDED|95.0|0.0|3.73||||||||3.73|0.00|
70999128|NCT02980692|141505448|SUPERIORITY||Proportion with Adjustment of Background|1.3|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|95.0|0.0|3.83||||||||3.83|0.00|
70999129|NCT02980692|141505448|SUPERIORITY||Proportion with Adjustment of Background|2.56|STANDARD_ERROR_OF_MEAN|1.79|||TWO_SIDED|95.0|0.0|6.07||||||||6.07|0.00|
70999130|NCT02980692|141505448|SUPERIORITY||Proportion with Adjustment of Background|1.27|STANDARD_ERROR_OF_MEAN|1.26|||TWO_SIDED|95.0|0.0|3.73||||||||3.73|0.00|
70999131|NCT02980692|141505449|SUPERIORITY||% response rate|85.07|STANDARD_ERROR_OF_MEAN|4.35|||TWO_SIDED|95.0|76.54|93.61||||||||93.61|76.54|
70999132|NCT02980692|141505449|SUPERIORITY||% response rate|81.25|STANDARD_ERROR_OF_MEAN|4.88|||TWO_SIDED|95.0|71.69|90.81||||||||90.81|71.69|
70999133|NCT02980692|141505449|SUPERIORITY||% response rate|76.27|STANDARD_ERROR_OF_MEAN|5.54|||TWO_SIDED|95.0|65.42|87.13||||||||87.13|65.42|
70999134|NCT02980692|141505449|SUPERIORITY||% response rate|71.05|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|95.0|60.86|81.25||||||||81.25|60.86|
70999135|NCT02980692|141505449|SUPERIORITY||% response rate|65.33|STANDARD_ERROR_OF_MEAN|5.5|||TWO_SIDED|95.0|54.56|76.1||||||||76.10|54.56|
70999136|NCT02980692|141505450|SUPERIORITY||% response rate|56.92|STANDARD_ERROR_OF_MEAN|6.14|||TWO_SIDED|95.0|44.88|68.96||||||||68.96|44.88|
70999137|NCT02980692|141505450|SUPERIORITY||% response rate|64.41|STANDARD_ERROR_OF_MEAN|6.23|||TWO_SIDED|95.0|52.19|76.62||||||||76.62|52.19|
70999138|NCT02980692|141505450|SUPERIORITY||% response rate|45.0|STANDARD_ERROR_OF_MEAN|6.42|||TWO_SIDED|95.0|32.41|57.59||||||||57.59|32.41|
70999139|NCT02980692|141505450|SUPERIORITY||% response rate|47.06|STANDARD_ERROR_OF_MEAN|6.05|||TWO_SIDED|95.0|35.2|58.92||||||||58.92|35.20|
70999140|NCT02980692|141505450|SUPERIORITY||% response rate|42.03|STANDARD_ERROR_OF_MEAN|5.94|||TWO_SIDED|95.0|30.38|53.68||||||||53.68|30.38|
70999141|NCT02980692|141505451|SUPERIORITY|||||||0.7081|||||||Cochran-Mantel-Haenszel|||||||0.7081
70999142|NCT02980692|141505451|SUPERIORITY|||||||0.9244|||||||Cochran-Mantel-Haenszel|||||||0.9244
70999143|NCT02980692|141505451|SUPERIORITY|||||||0.5365|||||||Cochran-Mantel-Haenszel|||||||0.5365
70999144|NCT02980692|141505451|SUPERIORITY|||||||0.2925|||||||Cochran-Mantel-Haenszel|||||||0.2925
70999145|NCT02980692|141505452|SUPERIORITY||Mean Difference (Net)|-14.453|STANDARD_DEVIATION|31.9358|||TWO_SIDED|||||||||||||
70999146|NCT02980692|141505452|SUPERIORITY||Mean Difference (Net)|-18.883|STANDARD_DEVIATION|57.1147|||TWO_SIDED|||||||||||||
70999147|NCT02980692|141505452|SUPERIORITY||Mean Difference (Net)|-27.084|STANDARD_DEVIATION|76.2272|||TWO_SIDED|||||||||||||
70999148|NCT02980692|141505452|SUPERIORITY||Mean Difference (Net)|-26.173|STANDARD_DEVIATION|87.5367|||TWO_SIDED|||||||||||||
70999149|NCT02980692|141505452|SUPERIORITY||Mean Difference (Net)|-50.399|STANDARD_DEVIATION|141.677|||TWO_SIDED|||||||||||||
70999150|NCT02980692|141505453|SUPERIORITY|||||||0.0203|||||||Cochran-Mantel-Haenszel|||||||0.0203
70999151|NCT02980692|141505453|SUPERIORITY|||||||0.5194|||||||Cochran-Mantel-Haenszel|||||||0.5194
70999152|NCT02980692|141505453|SUPERIORITY|||||||0.0599|||||||Cochran-Mantel-Haenszel|||||||0.0599
70999153|NCT02980692|141505453|SUPERIORITY|||||||0.122|||||||Cochran-Mantel-Haenszel|||||||0.1220
70999154|NCT02980692|141505454|SUPERIORITY||Mean Difference (Net)|-1.3|STANDARD_DEVIATION|1.86|||TWO_SIDED|||||||||||||
70999155|NCT02980692|141505454|SUPERIORITY||Mean Difference (Net)|-1.0|STANDARD_DEVIATION|1.56|||TWO_SIDED|||||||||||||
70999156|NCT02980692|141505454|SUPERIORITY||Mean Difference (Net)|-1.7|STANDARD_DEVIATION|2.08|||TWO_SIDED|||||||||||||
70999157|NCT02980692|141505454|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_DEVIATION|1.75|||TWO_SIDED|||||||||||||
70999158|NCT02980692|141505454|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_DEVIATION|1.82|||TWO_SIDED|||||||||||||
70999159|NCT01112982|141505486|OTHER|||||||0.34|||||||t-test, 2 sided|||Presence of synovial pannus and the serum urate level.||||0.34
70999160|NCT01112982|141505488|OTHER|Spearman Correlation Coefficient||||||0.73|||||||t-test, 1 sided|||The Severity of Synovial Pannus and the Serum Urate level.||||0.73
70999161|NCT01112982|141505489|OTHER|correlation between severity of synovial pannus and the serum urate level.||||||0.73|||||||t-test, 1 sided|||||||0.73
70999162|NCT01112982|141505490|OTHER|||||||0.32||||||"The presence of synovial pannus in the index joint."|t-test, 1 sided|||||||0.32
70999163|NCT01112982|141505491|OTHER|Kappa Coefficient||||||0.09|||||||t-test, 2 sided|||The absence of erosive changes.||||0.09
70999164|NCT01112982|141505491|OTHER|the absence of Intraosseous Tophi.||||||0.33|||||||t-test, 2 sided|||||||0.33
70999165|NCT01112982|141505491|OTHER|The absence of Soft Tissue Tophi||||||0.09|||||||t-test, 2 sided|||||||0.09
70999166|NCT01112982|141505491|OTHER|The absence of Joint Effusion.||||||0.31|||||||t-test, 2 sided|||||||0.31
70999167|NCT01112982|141505491|OTHER|The absence of Bone Marrow Edema.||||||0.25|||||||t-test, 2 sided|||||||0.25
70999168|NCT01112982|141505491|OTHER|The absence of Soft Tissue Edema.||||||0.14|||||||t-test, 2 sided|||||||0.14
70999169|NCT01112982|141505492|OTHER|||||||0.32||||||"The Presence of synovial Pannus in the index joint."|t-test, 1 sided|||||||0.32
70999170|NCT01112982|141505492|OTHER|||||||0.99||||||"The Severity of Synovial Pannus in the index joint."|t-test, 1 sided|||||||0.99
70999171|NCT01001234|141505500|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.025|TWO_SIDED|95.0|1.06|2.26||The statistical significance level for the primary endpoint was α=0.0477, and had been adjusted to account for the interim sample size adjustment.|Regression, Logistic|Testing of primary endpoint and secondary endpoints was conducted sequentially in a pre-specified order, thus strongly controlling Type I error.||The comparison of rizatriptan versus placebo with respect to the primary outcome was conducted using a logistic regression model with factors for treatment, Stage 2 baseline pain severity (moderate or severe) and region (United States \[US\] or ex-US). Model-derived odds ratio and a two-sided p-value were provided. An odds ratio \>1 is in favor of the rizatriptan group.||2.26|1.06|0.025
70999172|NCT01001234|141505501|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.35||||0.08|TWO_SIDED|95.0|0.96|1.9||Secondary endpoints were to be formally tested only if the test of the primary endpoint was statistically significant at the α=0.0477 level. The secondary endpoints were then tested sequentially in a pre-specified order, each at the α=0.05 level.|Regression, Logistic|This first secondary hypothesis was not statistically significant, therefore the other two were not formally tested for statistical significance.||The comparison of rizatriptan versus placebo with respect to pain relief at 2 hours post Stage 2 dose for participants between 12 and 17 years of age was conducted using a logistic regression model with factors for treatment, Stage 2 baseline pain severity (moderate or severe) and region (US or ex-US). Model-derived odds ratio and a two-sided p-value were provided. An odds ratio \>1 is in favor of the rizatriptan group.||1.90|0.96|0.080
70999173|NCT01001234|141505502|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.52||||0.01|TWO_SIDED|95.0|1.1|2.1||This second secondary hypothesis was not formally tested since the first secondary was not statistically significant.|Regression, Logistic|||The comparison of rizatriptan versus placebo with respect to pain freedom at 2 hours post Stage 2 dose for participants between 6 and 17 years of age was conducted using a logistic regression model with factors for treatment, Stage 2 baseline pain severity (moderate or severe), age (6 to 11 years old or 12 to 17 years old), and region (US or ex-US). Model-derived odds ratio and a two-sided p-value were provided. An odds ratio \>1 is in favor of the rizatriptan group.||2.10|1.10|0.010
70999174|NCT01001234|141505503|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.22||||0.178|TWO_SIDED|95.0|0.91|1.63||This third secondary hypothesis was not formally tested since the first secondary was not statistically significant.|Regression, Logistic|||The comparison of rizatriptan versus placebo with respect to pain relief at 2 hours post Stage 2 dose for participants between 6 and 17 years of age was conducted using a logistic regression model with factors for treatment, Stage 2 baseline pain severity (moderate or severe), age (6 to 11 years old or 12 to 17 years old), and region (US or ex-US). Model-derived odds ratio and a two-sided p-value were provided. An odds ratio \>1 is in favor of the rizatriptan group.||1.63|0.91|0.178
70999175|NCT01963780|141505527|SUPERIORITY|Performance goal is 65%.|Proportion|0.544||||0.9663|TWO_SIDED|95.0|0.428|0.657|||one-sided exact binomial test|||||0.657|0.428|0.9663
70999176|NCT01963780|141505528|OTHER|No statistical hypothesis testing|Proportion|0.167|||||TWO_SIDED|95.0|0.092|0.268||||||||0.268|0.092|
70999177|NCT01963780|141505529|OTHER|No statistical hypothesis testing|Proportion|0.064|||||TWO_SIDED|95.0|0.021|0.143||||||||0.143|0.021|
70999178|NCT01963780|141505530|OTHER|No statistical hypothesis testing|Mean|0.3|||||TWO_SIDED|95.0|0.1|0.4||||||||0.4|0.1|
70999179|NCT04153929|141505532|OTHER|Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.|||||<|0.0001|||||||MCP-Mod linear model fit|Model assumption: The maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
70999180|NCT04153929|141505532|OTHER|Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.|||||<|0.0001|||||||MCP-Mod Exponential model fit|Model assumption: 90% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
71100422|NCT02732145|141709660|SUPERIORITY|Question: Is there a difference in the frequency of non-specific vulvar lesions among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8662|||||||t-test proportion|||Parameter: The difference in the frequency of non-specific vulvar lesions in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8662
70999181|NCT04153929|141505532|OTHER|Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.|||||<|0.0001|||||||MCP-Mod Emax 1 model fit|Model assumption: 90% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
70999182|NCT04153929|141505532|OTHER|Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.|||||<|0.0001|||||||MCP-Mod Emax 2 model fit|Model assumption: 70% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
70999183|NCT04153929|141505532|OTHER|Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.|||||<|0.0001|||||||MCP-Mod Sigmoid Emax model fit|Model assumption: 50% of the maximum effect is achieved at 1.8 mg and 90% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
70999184|NCT04153929|141505532|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-0.76|||<|0.0001|TWO_SIDED|95.0|-1.06|-0.46||P-value is considered nominal.|Mixed Model for Repeated Measures|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 456906 0.3 mg - Placebo at Week 17.|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-0.46|-1.06|<0.0001
70999185|NCT04153929|141505532|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.31|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.01||P-value is considered nominal.|Mixed Model for Repeated Measures|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 456906 0.9 mg - Placebo at Week 17.|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-1.01|-1.60|<0.0001
70999186|NCT04153929|141505532|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.56|||<|0.0001|TWO_SIDED|95.0|-1.87|-1.26||P-value is considered nominal.|Mixed Model for Repeated Measures|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 456906 1.8 mg - Placebo at Week 17.|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-1.26|-1.87|<0.0001
70999187|NCT04153929|141505532|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.41|||<|0.0001|TWO_SIDED|95.0|-1.72|-1.1||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 456906 2.7 mg - Placebo at Week 17.|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-1.10|-1.72|<0.0001
70999188|NCT04153929|141505532|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.49|||<|0.0001|TWO_SIDED|95.0|-1.78|-1.19||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.2 twice weekly (2.4) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-1.19|-1.78|<0.0001
70999189|NCT04153929|141505532|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.53|||<|0.0001|TWO_SIDED|95.0|-1.84|-1.22||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 twice weekly (3.6) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-1.22|-1.84|<0.0001
71008570|NCT02055976|141525228|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-98.273|STANDARD_ERROR_OF_MEAN|5.898|<|0.001|TWO_SIDED|95.0|-109.983|-86.563|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-86.563|-109.983|<0.001
70999190|NCT04153929|141505533|OTHER|"Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod.~MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements."|||||<|0.0001|||||||MCP-Mod linear model fit|Model assumption: The maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
71008571|NCT02055976|141525228|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-71.435|STANDARD_ERROR_OF_MEAN|7.209|<|0.001|TWO_SIDED|95.0|-85.757|-57.112|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-57.112|-85.757|<0.001
71100423|NCT02732145|141709660|SUPERIORITY|Question: Is there a difference in the frequency of specific vulvar lesions among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||t-test proportion|||Parameter: The difference in the frequency of vulvar lesions specific for dermatosis in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
71100424|NCT02732145|141709661|SUPERIORITY|Question: Is there a difference in the frequency of vulvar complaints among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.5399|||||||t-test proportion|||Parameter: The difference in the frequency of vulvar complaints in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.5399
71100425|NCT02732145|141709661|SUPERIORITY|Question: Is there a difference in the frequency of positive Marinoff Index among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9248|||||||t-test proportion|||Parameter: The difference in the frequency of positive Marinoff Index in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9248
71100426|NCT02732145|141709661|SUPERIORITY|Question: Is there a difference in the frequency of the positive Cotton-Swab test among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9839|||||||t-test proportion|||Parameter: The difference in the frequency of the positive Cotton-Swab test in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9839
71100427|NCT02732145|141709661|SUPERIORITY|Question: Is there a difference in the frequency of any lesion in any vulvar ring among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.7537|||||||t|||Parameter: The difference in the frequency of any lesion in any vulvar ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.7537
71100428|NCT02732145|141709661|SUPERIORITY|Question: Is there a difference in the frequency of any vulvar lesion of the Outer Vulvar Ring among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.2054|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.2054
71008572|NCT02055976|141525228|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-94.959|STANDARD_ERROR_OF_MEAN|7.236|<|0.001|TWO_SIDED|95.0|-109.333|-80.585|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-80.585|-109.333|<0.001
71008573|NCT02055976|141525228|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-98.519|STANDARD_ERROR_OF_MEAN|7.15|<|0.001|TWO_SIDED|95.0|-112.727|-84.311|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-84.311|-112.727|<0.001
71008574|NCT02055976|141525228|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-55.191|STANDARD_ERROR_OF_MEAN|5.741|<|0.001|TWO_SIDED|95.0|-66.592|-43.791|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-43.791|-66.592|<0.001
71008575|NCT02055976|141525228|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-72.211|STANDARD_ERROR_OF_MEAN|5.848|<|0.001|TWO_SIDED|95.0|-83.825|-60.597|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-60.597|-83.825|<0.001
71008576|NCT02055976|141525228|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-83.065|STANDARD_ERROR_OF_MEAN|5.913|<|0.001|TWO_SIDED|95.0|-94.807|-71.323|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-71.323|-94.807|<0.001
71100429|NCT02732145|141709661|SUPERIORITY|Question: Is there a difference in the frequency of any vulvar lesion of the Middle Vulvar Ring among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.6409|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.6409
70999191|NCT04153929|141505533|OTHER|"Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod.~MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements."|||||<|0.0001|||||||MCP-Mod exponential model fit|Model assumption: 90% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
70999192|NCT04153929|141505533|OTHER|"Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod.~MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements."|||||<|0.0001|||||||MCP-Mod Emax 1 model fit|Model assumption: 90% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
70999193|NCT04153929|141505533|OTHER|"Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod.~MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements."|||||<|0.0001|||||||MCP-Mod Emax 2 model fit|Model assumption: 70% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
70999194|NCT04153929|141505533|OTHER|"Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod.~MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements."|||||<|0.0001|||||||MCP-Mod Sigmoid Emax model fit|Model assumption: 50% of the maximum effect is achieved at 1.8 mg and 90% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
70999195|NCT04153929|141505533|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.11||||0.2228|TWO_SIDED|95.0|-2.9|0.68||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 0.3 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||0.68|-2.90|0.2228
70999196|NCT04153929|141505533|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-3.79|||<|0.0001|TWO_SIDED|95.0|-5.56|-2.01||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 0.9 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-2.01|-5.56|<0.0001
71100430|NCT02732145|141709661|SUPERIORITY|Question: Is there a difference in the frequency of any vulvar lesion of the Inner Vulvar Ring among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9753|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9753
70999197|NCT04153929|141505533|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-5.61|||<|0.0001|TWO_SIDED|95.0|-7.41|-3.81||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-3.81|-7.41|<0.0001
70999198|NCT04153929|141505533|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-6.25|||<|0.0001|TWO_SIDED|95.0|-8.12|-4.38||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 2.7 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-4.38|-8.12|<0.0001
70999199|NCT04153929|141505533|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-6.25|||<|0.0001|TWO_SIDED|95.0|-8.02|-4.47||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.2 twice weekly (2.4) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-4.47|-8.02|<0.0001
70999200|NCT04153929|141505533|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-7.68|||<|0.0001|TWO_SIDED|95.0|-9.52|-5.83||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 twice weekly (3.6) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-5.83|-9.52|<0.0001
70999201|NCT04153929|141505534|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-0.66||||0.4439|TWO_SIDED|95.0|-2.34|1.03||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 0.3 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||1.03|-2.34|0.4439
70999202|NCT04153929|141505534|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-3.28||||0.0001|TWO_SIDED|95.0|-4.95|-1.61||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 0.9 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-1.61|-4.95|0.0001
70999203|NCT04153929|141505534|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-4.93|||<|0.0001|TWO_SIDED|95.0|-6.62|-3.23||P-value is considered nominal|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-3.23|-6.62|<0.0001
70999204|NCT04153929|141505534|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-5.76|||<|0.0001|TWO_SIDED|95.0|-7.53|-4.0||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 2.7 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-4.00|-7.53|<0.0001
70999205|NCT04153929|141505534|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-5.44|||<|0.0001|TWO_SIDED|95.0|-7.11|-3.77||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.2 twice weekly (2.4) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-3.77|-7.11|<0.0001
70999206|NCT04153929|141505534|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-7.05|||<|0.0001|TWO_SIDED|95.0|-8.79|-5.31||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 twice weekly (3.6) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-5.31|-8.79|<0.0001
71100431|NCT02732145|141709661|SUPERIORITY|Question: Is there a difference in the frequency of non-specific vulvar lesions among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8986|||||||t-test proportion|||Parameter: The difference in the frequency of non-specific vulvar lesions in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8986
70999207|NCT04153929|141505534|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-3.85|||<|0.0001|TWO_SIDED|95.0|-5.52|-2.18||P-value is considered nominal.|Mixed Model Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as Semaglutide - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-2.18|-5.52|<0.0001
70999208|NCT04153929|141505535|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-0.62||||0.7708|TWO_SIDED|95.0|-4.82|3.57||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 0.3 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||3.57|-4.82|0.7708
70999209|NCT04153929|141505535|OTHER|No formal hypotheses were tested.|Difference of adjusted means|0.68||||0.7462|TWO_SIDED|95.0|-3.44|4.79||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 0.9 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||4.79|-3.44|0.7462
70999210|NCT04153929|141505535|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-3.32||||0.1302|TWO_SIDED|95.0|-7.62|0.98||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||0.98|-7.62|0.1302
70999211|NCT04153929|141505535|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-4.61||||0.0414|TWO_SIDED|95.0|-9.03|-0.18||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 2.7 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-0.18|-9.03|0.0414
70999212|NCT04153929|141505535|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-2.55||||0.2273|TWO_SIDED|95.0|-6.71|1.6||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.2 twice weekly (2.4) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||1.60|-6.71|0.2273
70999213|NCT04153929|141505535|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-8.4||||0.0002|TWO_SIDED|95.0|-12.81|-3.98||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 twice weekly (3.6) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-3.98|-12.81|0.0002
70999214|NCT04153929|141505535|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-2.72||||0.1967|TWO_SIDED|95.0|-6.86|1.42||P-value is considered nominal.|Mixed Model Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as Semaglutide - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||1.42|-6.86|0.1967
71041771|NCT00407745|141592607|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.383||0.3312|TWO_SIDED|95.0|-1.13|0.38||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 1 - Burning pain~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.38|-1.13|0.3312
71041772|NCT00407745|141592607|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.377||0.0976|TWO_SIDED|95.0|-1.37|0.12||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 2 - Squeezing pain~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.12|-1.37|0.0976
71041773|NCT00407745|141592607|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.393||0.0538|TWO_SIDED|95.0|-1.54|0.01||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 3 - Pain like pressure~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.01|-1.54|0.0538
70999215|NCT04153929|141505536|OTHER||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.28|5.2|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||5.20|0.28|
70999216|NCT04153929|141505536|OTHER||Odds Ratio (OR)|7.92|||||TWO_SIDED|95.0|2.43|25.74|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||25.74|2.43|
70999217|NCT04153929|141505536|OTHER||Odds Ratio (OR)|17.68|||||TWO_SIDED|95.0|5.21|60.03|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||60.03|5.21|
70999218|NCT04153929|141505536|OTHER||Odds Ratio (OR)|25.87|||||TWO_SIDED|95.0|7.31|91.55|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||91.55|7.31|
70999219|NCT04153929|141505536|OTHER||Odds Ratio (OR)|21.75|||||TWO_SIDED|95.0|6.57|72.04|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||72.04|6.57|
70999220|NCT04153929|141505536|OTHER||Odds Ratio (OR)|35.0|||||TWO_SIDED|95.0|9.84|124.47|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||124.47|9.84|
70999221|NCT04153929|141505536|OTHER||Odds Ratio (OR)|8.22|||||TWO_SIDED|95.0|2.52|26.79|||||Odds Ratio was calculated as Semaglutide / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||26.79|2.52|
70999222|NCT04153929|141505537|OTHER||Odds Ratio (OR)|3.67|||||TWO_SIDED|95.0|0.14|95.73|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||95.73|0.14|
70999223|NCT04153929|141505537|OTHER||Odds Ratio (OR)|7.97|||||TWO_SIDED|95.0|0.39|163.56|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||163.56|0.39|
70999224|NCT04153929|141505537|OTHER||Odds Ratio (OR)|25.17|||||TWO_SIDED|95.0|1.35|471.09|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||471.09|1.35|
70999225|NCT04153929|141505537|OTHER||Odds Ratio (OR)|33.01|||||TWO_SIDED|95.0|1.78|613.51||||||Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||613.51|1.78|
70999226|NCT04153929|141505537|OTHER||Odds Ratio (OR)|42.44|||||TWO_SIDED|95.0|2.37|761.44|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||761.44|2.37|
70999227|NCT04153929|141505537|OTHER||Odds Ratio (OR)|84.53|||||TWO_SIDED|95.0|4.71|999.0|||||Odds Ratio was calculated as BI 456906 / Placebo. The upper limit is bigger than 999.|Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||999|4.71|
70999228|NCT04153929|141505537|OTHER||Odds Ratio (OR)|22.44|||||TWO_SIDED|95.0|1.22|413.33|||||Odds Ratio was calculated as Semaglutide / Placebo.|Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||413.33|1.22|
70999229|NCT02971293|141505600|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
70999230|NCT02971293|141505600|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
70999231|NCT02971293|141505600|SUPERIORITY|||||||0.02|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.020
70999232|NCT02971293|141505612|SUPERIORITY|||||||0.002|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.002
70999233|NCT02971293|141505612|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
70999234|NCT02971293|141505612|SUPERIORITY|||||||0.011|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.011
70999235|NCT02971293|141505613|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
71100432|NCT02732145|141709661|SUPERIORITY|Question: Is there a difference in the frequency of specific vulvar lesions among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology (first biopsy)?||||||0.0017|||||||t-test proportion|||Parameter: The difference in the frequency of vulvar lesions specific for dermatosis in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology (first biopsy).||||0.0017
71100433|NCT02732145|141709662|EQUIVALENCE|Question: Is there a difference in the score for vulvar complaints (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for vulvar complaints (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
70999236|NCT02971293|141505613|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
70999237|NCT02971293|141505613|SUPERIORITY|||||||0.201|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.201
70999238|NCT02971293|141505614|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment\*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
70999239|NCT02971293|141505614|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment\*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
70999240|NCT02971293|141505614|SUPERIORITY|||||||0.02|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment\*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.020
70999241|NCT02971293|141505615|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
70999242|NCT02971293|141505615|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
71100434|NCT02732145|141709662|EQUIVALENCE|Question: Is there a difference in the score for Marinoff Index (mean) among patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9899|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for Marinoff Index (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9899
71100435|NCT02732145|141709662|EQUIVALENCE|Question: Is there a difference in the score for the Cotton-Swab test (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9686|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the Cotton-Swab test (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9686
71041774|NCT00407745|141592607|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.389||0.3239|TWO_SIDED|95.0|-1.15|0.38||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 5 - Electric shocks~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.38|-1.15|0.3239
71041775|NCT00407745|141592607|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.376||0.1912|TWO_SIDED|95.0|-1.23|0.25||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 6 - Stabbing pain~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.25|-1.23|0.1912
71041776|NCT00407745|141592607|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.353||0.672|TWO_SIDED|95.0|-0.55|0.85||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 8 - By light touching~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.85|-0.55|0.6720
71041777|NCT00407745|141592607|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.33||0.7821|TWO_SIDED|95.0|-0.74|0.56||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 9 - By pressure~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.56|-0.74|0.7821
71041778|NCT00407745|141592607|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.352||0.6851|TWO_SIDED|95.0|-0.84|0.55||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 10 - By something cold~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.55|-0.84|0.6851
70999243|NCT02971293|141505615|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||<0.001
70999244|NCT02971293|141505616|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
70999245|NCT02971293|141505616|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
70999246|NCT02971293|141505616|SUPERIORITY|||||||0.092|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.092
70999247|NCT02971293|141505617|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
71041779|NCT00407745|141592607|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.387||0.361|TWO_SIDED|95.0|-1.12|0.41||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 11 - Pins and needles~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.41|-1.12|0.3610
71041780|NCT00407745|141592607|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.402||0.4915|TWO_SIDED|95.0|-1.07|0.52||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 12 - Tingling~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.52|-1.07|0.4915
70999248|NCT02971293|141505617|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
70999249|NCT02971293|141505617|SUPERIORITY|||||||0.279|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.279
70999250|NCT02971293|141505618|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment\*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
70999251|NCT02971293|141505618|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment\*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
70923891|NCT01820260|141339733|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||Analysis of partial clearance of AK's at Week 8 was done in the same way as for the primary outcome (endpoint)||||<0.001
70999252|NCT02971293|141505618|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment\*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||<0.001
70999253|NCT02971293|141505619|SUPERIORITY|||||||0.205|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.205
70999254|NCT02971293|141505619|SUPERIORITY|||||||0.002|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||0.002
70999255|NCT02971293|141505619|SUPERIORITY|||||||0.06|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.060
70999256|NCT02971293|141505620|SUPERIORITY|||||||0.111|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.111
70999257|NCT02971293|141505620|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
70999258|NCT02971293|141505620|SUPERIORITY|||||||0.015|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.015
70999259|NCT02971293|141505621|SUPERIORITY|||||||0.621|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.621
70999260|NCT02971293|141505621|SUPERIORITY|||||||0.138|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||0.138
70999261|NCT02971293|141505621|SUPERIORITY|||||||0.333|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.333
70999262|NCT02971293|141505622|SUPERIORITY|||||||0.748|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.748
70999263|NCT02971293|141505622|SUPERIORITY|||||||0.005|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||0.005
70999264|NCT02971293|141505622|SUPERIORITY|||||||0.013|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.013
70999265|NCT02971293|141505623|SUPERIORITY|||||||0.064|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.064
70999266|NCT02971293|141505623|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
70923892|NCT01820260|141339733|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
70923893|NCT01820260|141339733|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
70923894|NCT01820260|141339733|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
70923895|NCT02384317|141339769|SUPERIORITY||Slope|-2.4|STANDARD_DEVIATION|141.77||0.965|TWO_SIDED|95.0|-133.6|128.7|||Random coefficients regression|||||128.7|-133.6|0.965
70999267|NCT02971293|141505623|SUPERIORITY|||||||0.03|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.030
70999268|NCT02971293|141505624|SUPERIORITY|||||||0.018|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.018
70999269|NCT02971293|141505624|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
70999270|NCT02971293|141505624|SUPERIORITY|||||||0.047|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.047
70999271|NCT02971293|141505625|SUPERIORITY|||||||0.477|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.477
70999272|NCT02971293|141505625|SUPERIORITY|||||||0.014|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||0.014
70999273|NCT02971293|141505625|SUPERIORITY|||||||0.084|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.084
70999274|NCT02971293|141505626|SUPERIORITY|||||||0.213|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.213
71100436|NCT02732145|141709662|EQUIVALENCE|Question: Is there a difference in the score for any lesion in any vulvar ring (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.7055|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any lesion in any vulvar ring (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.7055
71100437|NCT02732145|141709662|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Outer Vulvar Ring (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8852|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Outer Vulvar Ring (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8852
70999275|NCT02971293|141505626|SUPERIORITY|||||||0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||0.001
70999276|NCT02971293|141505626|SUPERIORITY|||||||0.046|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.046
70999277|NCT00729326|141505627|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-values were not adjusted. The primary measure was change in 24-hour glucose without multiplicity adjustments for other analyses.|ANCOVA|Analyses for continuous variables adjusted for treatment, period, sequence, baseline of the continuous variable.Analysis method was Grizzle's model.||Null hypothesis: The 24-hour average glucose for exenatide was greater than or equal to that for sitagliptin after 4 weeks of treatment. The primary objective was to compare exenatide with sitagliptin on the time-averaged glucose during the 24-hour inpatient periods after 4 weeks of treatment.||||<.001
70999278|NCT00729326|141505628|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
70999279|NCT00729326|141505629|SUPERIORITY_OR_OTHER|||||||0.766||95.0|||||ANCOVA|||||||.766
70999280|NCT00729326|141505630|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
70999281|NCT00729326|141505631|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
70999282|NCT00729326|141505632|SUPERIORITY_OR_OTHER|||||||0.117||95.0|||||ANCOVA|||||||.117
70999283|NCT00729326|141505633|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
70999284|NCT00729326|141505634|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
70999285|NCT00729326|141505635|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
70999286|NCT00729326|141505636|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
70999287|NCT00729326|141505637|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
70999288|NCT00729326|141505638|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
70999289|NCT00729326|141505639|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
70999290|NCT03418051|141505656|SUPERIORITY|||||||0.824||||||A priori alpha level was set to 0.05|ANOVA|||||||0.824
70999291|NCT03418051|141505656|SUPERIORITY|||||||0.426||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.426
70999292|NCT03418051|141505657|SUPERIORITY|||||||0.722||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.722
70999293|NCT03418051|141505657|SUPERIORITY|||||||0.843||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.843
70999294|NCT03418051|141505658|SUPERIORITY|||||||0.046||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.046
70999295|NCT03418051|141505658|SUPERIORITY|||||||0.845||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.845
70999296|NCT03418051|141505659|SUPERIORITY|||||||0.138||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.138
71041781|NCT00407745|141592608|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0536||95.0||||p-values are adjusted for baseline score. Significance was declared if p-value \<=0.05.|Cochran-Mantel-Haenszel|||Null hypothesis - The rate of subjects with improvement for the pregabain group was equal to the rate of subjects with improvement for the placebo group; Alternative hypothesis - The rate of subjects with improvement for the pregabain group was not equal to the rate of subjects with improvement for the placebo group.||||0.0536
71041782|NCT00407745|141592609|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3107||95.0||||p-values are adjusted for baseline score. Significance was declared if p-value \<=0.05.|Cochran-Mantel-Haenszel|||Null hypothesis - The rate of subjects with improvement for the pregabain group was equal to the rate of subjects with improvement for the placebo group; Alternative hypothesis - The rate of subjects with improvement for the pregabain group was not equal to the rate of subjects with improvement for the placebo group.||||0.3107
71100438|NCT02732145|141709662|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Middle Vulvar Ring (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Middle Vulvar Ring (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
70999297|NCT03418051|141505659|SUPERIORITY|||||||0.523||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.523
70999298|NCT03418051|141505660|SUPERIORITY|||||||0.069||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.069
70999299|NCT03418051|141505660|SUPERIORITY|||||||0.413||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.413
70999300|NCT03418051|141505661|SUPERIORITY|||||||0.604||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.604
70999301|NCT03418051|141505661|SUPERIORITY|||||||0.499||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.499
70999302|NCT03418051|141505662|SUPERIORITY|||||||0.005||||||A priori threshold was set at 0.05.|ANOVA|||||||0.005
70999303|NCT03418051|141505662|SUPERIORITY|||||||0.853||||||A priori threshold set at 0.05.|ANOVA|||||||0.853
70999304|NCT03418051|141505663|SUPERIORITY|||||||0.142||||||A priori threshold set to 0.05|ANOVA|||||||0.142
70999305|NCT03418051|141505663|SUPERIORITY|||||||0.167||||||A priori threshold set at 0.05.|ANOVA|||||||0.167
70999306|NCT03418051|141505664|SUPERIORITY|||||||0.849||||||A priori alpha set at 0.05.|ANOVA|||||||0.849
70999307|NCT03418051|141505664|SUPERIORITY|||||||0.993||||||A priori threshold set at 0.05.|ANOVA|||||||0.993
70999308|NCT03418051|141505665|SUPERIORITY|||||||0.535||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.535
70999309|NCT03418051|141505665|SUPERIORITY|||||||0.569||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.569
71100439|NCT02732145|141709662|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Inner Vulvar Ring (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.3351|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Inner Vulvar Ring (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.3351
71100440|NCT02732145|141709662|EQUIVALENCE|Question: Is there a difference in the score for the specificity of vulvar lesions (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8673|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the specificity of vulvar lesions (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8673
70999310|NCT03418051|141505666|SUPERIORITY|||||||0.405||||||A priori threshold was 0.05.|ANOVA|||||||0.405
70999311|NCT03418051|141505666|SUPERIORITY|||||||0.229||||||A priori threshold set to 0.05.|ANOVA|||||||0.229
70999312|NCT03418051|141505667|SUPERIORITY|||||||0.609||||||A priori threshold set at 0.05.|ANOVA|||||||0.609
70999313|NCT03418051|141505667|SUPERIORITY|||||||0.027||||||A priori threshold was set at 0.05.|ANOVA|||||||0.027
70999314|NCT03418051|141505668|SUPERIORITY|||||||0.613||||||A priori alpha set at 0.05.|Independent sample Mann-Whitney U|||||||0.613
70999315|NCT03418051|141505669|SUPERIORITY|||||||0.925||||||A priori threshold set at 0.05.|Independent sample Mann-Whitney U|||||||0.925
70999316|NCT03418051|141505670|SUPERIORITY|||||||0.641||||||A priori threshold set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.641
70999317|NCT03418051|141505670|SUPERIORITY|||||||0.897||||||A priori threshold set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.897
70999318|NCT03418051|141505671|SUPERIORITY|||||||0.561||||||A priori threshold set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.561
70999319|NCT03418051|141505671|SUPERIORITY|||||||0.925||||||A priori threshold set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.925
70999320|NCT03418051|141505672|SUPERIORITY|||||||0.233||||||A priori threshold set at 0.05|ANOVA|||||||0.233
70999321|NCT03418051|141505672|SUPERIORITY|||||||0.634||||||A priori threshold set at 0.05|ANOVA|||||||0.634
70999322|NCT03418051|141505673|SUPERIORITY|||||||0.233||||||A priori threshold set at 0.05.|ANOVA|||||||0.233
70999323|NCT03418051|141505673|SUPERIORITY|||||||0.634||||||A priori threshold set at 0.05.|ANOVA|||||||0.634
70999324|NCT03418051|141505674|SUPERIORITY|||||||0.03||||||A priori threshold set at 0.05.|ANOVA|||||||0.030
70999325|NCT03418051|141505674|SUPERIORITY|||||||0.618||||||A priori threshold set at 0.05.|ANOVA|||||||0.618
70999326|NCT03418051|141505675|SUPERIORITY|||||||0.456||||||A priori threshold set at 0.05.|ANOVA|||||||0.456
71100441|NCT02732145|141709662|EQUIVALENCE|Question: Is there a difference in the score for non-specific vulvar lesions (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8673|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for non-specific vulvar lesions (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8673
70999327|NCT03418051|141505675|SUPERIORITY|||||||0.568||||||A priori threshold set to 0.05.|ANOVA|||||||0.568
70999328|NCT03418051|141505676|SUPERIORITY|||||||0.919||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.919
70999329|NCT03418051|141505676|SUPERIORITY|||||||0.558||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.558
70999330|NCT03418051|141505677|SUPERIORITY|||||||0.796||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.796
70999331|NCT03418051|141505677|SUPERIORITY|||||||0.558||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.558
70999332|NCT03418051|141505678|SUPERIORITY|||||||0.701||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.701
70999333|NCT03418051|141505678|SUPERIORITY|||||||0.68||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.68
70999334|NCT03418051|141505679|SUPERIORITY|||||||0.883||||||A priori threshold set at 0.05.|ANOVA|||||||0.883
70999335|NCT03418051|141505679|SUPERIORITY|||||||0.401||||||A priori threshold set at 0.05.|ANOVA|||||||0.401
70999336|NCT03418051|141505680|SUPERIORITY|||||||0.393||||||A priori threshold set at 0.05.|ANOVA|||||||0.393
70999337|NCT03418051|141505680|SUPERIORITY|||||||0.779||||||A priori threshold set at 0.05.|ANOVA|||||||0.779
70999338|NCT03418051|141505681|SUPERIORITY|||||||0.246||||||A priori threshold set at 0.05.|ANOVA|||||||0.246
70999339|NCT03418051|141505681|SUPERIORITY|||||||0.191||||||A priori threshold set at 0.05.|ANOVA|||||||0.191
70999340|NCT03418051|141505682|SUPERIORITY|||||||0.703||||||A priori threshold set at 0.05.|ANOVA|||||||0.703
70999341|NCT03418051|141505682|SUPERIORITY|||||||0.282||||||A priori threshold set at 0.05.|ANOVA|||||||0.282
70999342|NCT03418051|141505683|SUPERIORITY|||||||0.925||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.925
70999343|NCT03418051|141505683|SUPERIORITY|||||||0.551||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.551
70999344|NCT03418051|141505684|SUPERIORITY|||||||0.506||||||A priori threshold set at 0.05.|ANOVA|||||||0.506
70999345|NCT03418051|141505684|SUPERIORITY|||||||0.753||||||A priori threshold at 0.05.|ANOVA|||||||0.753
70999346|NCT03418051|141505685|SUPERIORITY|||||||0.777||||||A priori threshold set at 0.05.|ANOVA|||||||0.777
70999347|NCT03418051|141505685|SUPERIORITY|||||||0.475||||||A priori threshold set at 0.05.|ANOVA|||||||0.475
70999348|NCT03418051|141505686|SUPERIORITY|||||||0.738||||||A priori threshold set at 0.05.|ANOVA|||||||0.738
70999349|NCT03418051|141505686|SUPERIORITY|||||||0.042||||||A priori threshold set at 0.05.|ANOVA|||||||0.042
70999350|NCT03418051|141505687|SUPERIORITY|||||||0.738||||||A priori threshold set at 0.05.|ANOVA|||||||0.738
70999351|NCT03418051|141505687|SUPERIORITY|||||||0.83||||||A priori threshold set at 0.05.|ANOVA|||||||0.830
70999352|NCT03418051|141505688|SUPERIORITY|||||||0.7||||||A priori threshold set at 0.05.|ANOVA|||||||0.700
70999353|NCT03418051|141505688|SUPERIORITY|||||||0.492||||||A priori threshold set at 0.05.|ANOVA|||||||0.492
70999354|NCT03418051|141505689|SUPERIORITY|||||||0.82||||||A priori threshold set at 0.05.|ANOVA|||||||0.820
70999355|NCT03418051|141505689|SUPERIORITY|||||||0.526||||||A priori threshold set at 0.05.|ANOVA|||||||0.526
70999356|NCT02193828|141505702|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||For surface area||||<.0001
70999357|NCT02193828|141505702|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||For surface area||||<.0001
70999358|NCT02193828|141505702|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||For surface area||||<.0001
70999359|NCT02193828|141505702|SUPERIORITY_OR_OTHER|||||||0.0713|TWO_SIDED||||||ANOVA|||For surface area||||.0713
70999360|NCT02193828|141505702|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||ANOVA|||For volume||||.0002
70999361|NCT02193828|141505702|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANOVA|||For volume||||.0001
70999362|NCT02193828|141505702|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANOVA|||For volume||||.0001
70999363|NCT02193828|141505702|SUPERIORITY_OR_OTHER|||||||0.0446|TWO_SIDED||||||ANOVA|||For volume||||.0446
70999364|NCT02193828|141505703|SUPERIORITY_OR_OTHER|||||||0.2431|TWO_SIDED||||||ANOVA|||For surface area||||.2431
70999365|NCT02193828|141505703|SUPERIORITY_OR_OTHER|||||||0.0625|TWO_SIDED||||||ANOVA|||For surface area||||.0625
70999366|NCT02193828|141505703|SUPERIORITY_OR_OTHER|||||||0.3409|TWO_SIDED||||||ANOVA|||For surface area||||.3409
70999367|NCT02193828|141505703|SUPERIORITY_OR_OTHER|||||||0.704|TWO_SIDED||||||ANOVA|||For surface area||||.7040
70999368|NCT02193828|141505703|SUPERIORITY_OR_OTHER|||||||0.3556|TWO_SIDED||||||ANOVA|||For volume||||0.3556
70999369|NCT02193828|141505703|SUPERIORITY_OR_OTHER|||||||0.1275|TWO_SIDED||||||ANOVA|||For volume||||.1275
70999370|NCT02193828|141505703|SUPERIORITY_OR_OTHER|||||||0.7883|TWO_SIDED||||||ANOVA|||For volume||||.7883
70999371|NCT02193828|141505703|SUPERIORITY_OR_OTHER|||||||0.9123|TWO_SIDED||||||ANOVA|||For volume||||.9123
70999372|NCT02193828|141505704|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Kruskal-Wallis|||||||.0002
70999373|NCT02193828|141505704|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<.0001
70999374|NCT02193828|141505704|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0002
70999375|NCT02193828|141505704|SUPERIORITY_OR_OTHER|||||||0.0139|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0139
70999376|NCT02193828|141505705|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||ANOVA|||||||.0004
70999377|NCT02193828|141505705|SUPERIORITY_OR_OTHER|||||||0.0075|TWO_SIDED||||||ANOVA|||||||.0075
70999378|NCT02193828|141505705|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||||||<.0001
70999379|NCT02193828|141505705|SUPERIORITY_OR_OTHER|||||||0.0031|TWO_SIDED||||||ANOVA|||||||.0031
70999380|NCT02193828|141505706|SUPERIORITY_OR_OTHER|||||||0.3135|TWO_SIDED||||||ANOVA|||||||.3135
70999381|NCT02193828|141505706|SUPERIORITY_OR_OTHER|||||||0.7249|TWO_SIDED||||||ANOVA|||||||.7249
70999382|NCT02193828|141505706|SUPERIORITY_OR_OTHER|||||||0.1573|TWO_SIDED||||||ANOVA|||||||.1573
70999383|NCT02193828|141505706|SUPERIORITY_OR_OTHER|||||||0.1234|TWO_SIDED||||||ANOVA|||||||.1234
70999384|NCT02193828|141505707|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||Kruskal-Wallis|||||||.0006
70999385|NCT02193828|141505707|SUPERIORITY_OR_OTHER|||||||0.0014|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0014
70999386|NCT02193828|141505707|SUPERIORITY_OR_OTHER|||||||0.0012|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0012
70999387|NCT02193828|141505707|SUPERIORITY_OR_OTHER|||||||0.1298|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.1298
70999388|NCT02193828|141505708|SUPERIORITY_OR_OTHER|||||||0.0048|TWO_SIDED||||||Kruskal-Wallis|||||||.0048
70999389|NCT02193828|141505708|SUPERIORITY_OR_OTHER|||||||0.0034|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0034
70999390|NCT02193828|141505708|SUPERIORITY_OR_OTHER|||||||0.0079|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0079
70999391|NCT02193828|141505708|SUPERIORITY_OR_OTHER|||||||0.3216|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.3216
70999392|NCT02193828|141505709|SUPERIORITY_OR_OTHER|||||||0.0065|TWO_SIDED||||||Fisher Exact|||||||.0065
70999393|NCT02193828|141505709|SUPERIORITY_OR_OTHER|||||||0.0349|TWO_SIDED||||||Fisher Exact|||||||.0349
70999394|NCT02193828|141505709|SUPERIORITY_OR_OTHER|||||||0.0033|TWO_SIDED||||||Fisher Exact|||||||.0033
70999395|NCT02193828|141505709|SUPERIORITY_OR_OTHER|||||||0.3423|TWO_SIDED||||||Fisher Exact|||||||.3423
70999396|NCT01686958|141505727|OTHER|This is a primarily descriptive study, no statistical analysis is planned; however, analyses were performed at the alpha=0.05 level of significance and exact analyses will be used wherever possible.|||||||ONE_SIDED|95.0||||Confidence intervals \[CI\] will be constructed for outcomes of interest at the alpha=0.05 level of significance, i.e. 95% CI.||||A total of 30 subjects will be accrued to this study and treated with the PAD-105. The sample size is based primarily on feasibility and logistical concerns, however, is sufficiently large to allow the safety objectives to be met. Specifically, with 30 total patients, if no treatment-related grade 4 or 5 adverse events are observed, then a one-sided, 95% confidence interval would have an upper bound of 0.095.|For continuous outcomes, standard summary statistics will include n, mean, standard deviation, median, minimum and maximum. For categorical data, tables will show n and % of patients.|||
70999397|NCT03162458|141505735|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
70999398|NCT03162458|141505736|SUPERIORITY|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|||||||0.0004
70999399|NCT03162458|141505737|SUPERIORITY|||||||0.055|||||||Log Rank|||||||0.055
70999400|NCT03162458|141505738|SUPERIORITY|||||||0.051|||||||Wilcoxon (Mann-Whitney)|||||||0.051
70999401|NCT03162458|141505739|SUPERIORITY|||||||0.19|||||||ANOVA|||Mean body temperatures, measured in the morning on Days 2-5 (based on patient diary data)||||0.19
70999402|NCT03162458|141505739|SUPERIORITY|||||||0.44|||||||ANOVA|||Mean body temperatures, measured in the evening on Days 2-5 (based on patient diary data)||||0.44
71100442|NCT02732145|141709662|EQUIVALENCE|Question: Is there a difference in the score for specific vulvar lesions (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for specific vulvar lesions (mean) with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
71100443|NCT02732145|141709662|EQUIVALENCE|"Question: Is there a difference in the overall sum of points for the Vulvoscopy Index (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8472|||||||Wilcoxon (Mann-Whitney)|||"Parameter: The difference in the overall sum of points for the Vulvoscopy Index (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8472
70999403|NCT03162458|141505740|SUPERIORITY|||||||0.15|||||||Log Rank|||||||0.15
70999404|NCT03162458|141505741|SUPERIORITY|||||||0.004|||||||ANOVA|||||||0.004
70999405|NCT03162458|141505742|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
70999406|NCT03162458|141505743|SUPERIORITY|||||||0.63|||||||ANOVA|||||||0.63
70999407|NCT03162458|141505744|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
70999408|NCT00788697|141505752|SUPERIORITY_OR_OTHER||Difference in Sensitivity (%)|11.3||||0.0754|TWO_SIDED|95.0|-1.0|23.6|||McNemar|||||23.6|-1.0|0.0754
70999409|NCT00788697|141505752|SUPERIORITY_OR_OTHER||Difference in Sensitivity (%)|19.4||||0.0011|TWO_SIDED|95.0|8.3|30.5|||McNemar|||||30.5|8.3|0.0011
70999410|NCT00788697|141505752|SUPERIORITY_OR_OTHER||Difference in Sensitivity (%)|-19.4||||0.0016|TWO_SIDED|95.0|-30.9|-7.8|||McNemar|||||-7.8|-30.9|0.0016
70999411|NCT00788697|141505753|SUPERIORITY_OR_OTHER||Difference in Specificity (%)|47.4|||<|0.0001|TWO_SIDED|95.0|37.4|57.4|||McNemar|||||57.4|37.4|<.0001
70999412|NCT00788697|141505753|SUPERIORITY_OR_OTHER||Difference in Specificity (%)|60.3|||<|0.0001|TWO_SIDED|95.0|50.5|70.2|||McNemar|||||70.2|50.5|<.0001
70999413|NCT00788697|141505753|SUPERIORITY_OR_OTHER||Difference in Specificity (%)|29.3|||<|0.0001|TWO_SIDED|95.0|19.7|38.9|||McNemar|||||38.9|19.7|<.0001
70999414|NCT00788697|141505754|SUPERIORITY_OR_OTHER||Difference in Accuracy (%)|28.8|||<|0.0001|TWO_SIDED|95.0|20.5|37.0|||McNemar|||||37.0|20.5|<.0001
70999415|NCT00788697|141505754|SUPERIORITY_OR_OTHER||Difference in Accuracy (%)|39.2|||<|0.0001|TWO_SIDED|95.0|31.3|47.1|||McNemar|||||47.1|31.3|<.0001
70999416|NCT00788697|141505754|SUPERIORITY_OR_OTHER||Difference in Accuracy (%)|4.2||||0.3173|TWO_SIDED|95.0|-4.0|12.3|||McNemar|||||12.3|-4.0|0.3173
71041783|NCT00407745|141592610|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.89|STANDARD_ERROR_OF_MEAN|2.182||0.0262|TWO_SIDED|95.0|-9.19|-0.59||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline MOS 9-item Sleep Problems Index as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-0.59|-9.19|0.0262
70999417|NCT00788697|141505755|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
70999418|NCT00788697|141505755|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
70999419|NCT00788697|141505755|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Wald Test|||||||0.0004
70999420|NCT00788697|141505756|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
70999421|NCT00788697|141505756|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
70999422|NCT00788697|141505756|SUPERIORITY_OR_OTHER|||||||0.761|||||||Wald Test|||||||0.7610
70999423|NCT01998880|141505764|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.36|0.59||Type I error controlled through closed test procedure.|Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.59|0.36|<0.0001
70999424|NCT01998880|141505766|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39|||<|0.0001|TWO_SIDED|95.0|0.31|0.5|||Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.50|0.31|<0.0001
70999425|NCT01998880|141505767|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.2841|TWO_SIDED|95.0|0.61|1.16|||Log Rank, Stratified||Stratified by Binet stage at Baseline.|||1.16|0.61|0.2841
70999426|NCT01998880|141505768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.31|||<|0.0001|TWO_SIDED|95.0|23.5|45.1|||Chi-squared|||||45.1|23.5|<0.0001
70999427|NCT01998880|141505770|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.35|0.61|||Log-ranked, Stratified||Stratified by Binet stage at Baseline.|||0.61|0.35|<0.0001
70999428|NCT01998880|141505774|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.4|||<|0.0001|TWO_SIDED|95.0|0.3|0.53|||Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.53|0.30|<0.0001
70999429|NCT01998880|141505775|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.45|||<|0.0001|TWO_SIDED|95.0|0.31|0.65|||Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.65|0.31|<0.0001
71041784|NCT00407745|141592611|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.67|STANDARD_ERROR_OF_MEAN|2.985||0.0041|TWO_SIDED|95.0|-14.55|-2.78||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline MOS - Sleep disturbance as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-2.78|-14.55|0.0041
70999430|NCT01998880|141505776|SUPERIORITY||Difference in Response Rates|33.04|||<|0.0001|TWO_SIDED|95.0|22.1|43.9|||Chi-squared|||Includes subjects with best overall response: CR, CRi, PR or nPR.||43.9|22.1|< 0.0001
70999431|NCT00141037|141505900|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Wilcoxon Nonparametric Test|||The endpoint is assessed using a Wilcoxon nonparametric test and missing values are imputed using the last observation carried forward.||||0.79
70999432|NCT00141037|141505901|SUPERIORITY_OR_OTHER|||||||0.85|||||||Fisher Exact|||The difference was analyzed using a Fisher's exact test.||||0.85
70999433|NCT01938001|141505917|SUPERIORITY||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.34|0.62|||Log Rank|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).|Hazard ratio and its confidence interval (CI) were estimated from Cox proportional hazard model adjusting for the stratification factors noted above.|||0.62|0.34|< 0.0001
70999434|NCT01938001|141505918|SUPERIORITY|||||||0.0006|||||||Cochran-Mantel-Haenszel|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).||||||0.0006
70923896|NCT04936035|141339820|SUPERIORITY||Difference in LS Mean|-16.7|STANDARD_ERROR_OF_MEAN|1.9|<|0.0001|TWO_SIDED|95.0|-21.2|-12.3||MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM as a covariate.|MMRM|The adjusted 95% CI and p-value are based on Dunnett's test.|LS Mean Difference between zilebesiran 300 mg Q6M and placebo, 95% CI was calculated using Dunnett's procedure.|||-12.3|-21.2|<0.0001
70923897|NCT04936035|141339820|SUPERIORITY||Difference in LS Mean|-15.7|STANDARD_ERROR_OF_MEAN|2.19|<|0.0001|TWO_SIDED|95.0|-20.8|-10.6||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM as a covariate.|MMRM|The adjusted 95% CI and p-value are based on Dunnett's test.|LS Mean Difference between zilebesiran 600 mg Q6M and placebo, 95% CI was calculated using Dunnett's procedure.|||-10.6|-20.8|<0.0001
70923898|NCT04936035|141339821|SUPERIORITY||Difference in LS Mean|-12.0|STANDARD_ERROR_OF_MEAN|1.89|<|0.0001|TWO_SIDED|95.0|-15.7|-8.3||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with office SBP as a covariate.|MMRM|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||-8.3|-15.7|<0.0001
70923899|NCT04936035|141339821|SUPERIORITY||Difference in LS Mean|-9.1|STANDARD_ERROR_OF_MEAN|2.19|<|0.0001|TWO_SIDED|95.0|-13.4|-4.8||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with office SBP as a covariate.|MMRM|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||-4.8|-13.4|<0.0001
70923900|NCT04936035|141339822|SUPERIORITY||Difference in LS Mean|-14.1|STANDARD_ERROR_OF_MEAN|2.4|<|0.0001|TWO_SIDED|95.0|-18.9|-9.4||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM as a covariate.|MMRM|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||-9.4|-18.9|<0.0001
70999435|NCT01938001|141505919|SUPERIORITY||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.37|0.95||||||Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).||0.95|0.37|
70999436|NCT01938001|141505920|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).||||||< 0.0001
70999437|NCT01938001|141505921|SUPERIORITY||||||=|0.001|||||||Cochran-Mantel-Haenszel|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).||||||= 0.0010
70999438|NCT01938001|141505922|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0015|TWO_SIDED|95.0|0.36|0.79|||Log Rank|||||0.79|0.36|0.0015
70999439|NCT01938001|141505923|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.2993|TWO_SIDED|95.0|0.32|1.43|||Log Rank|||||1.43|0.32|0.2993
70999440|NCT01938001|141505924|SUPERIORITY||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.38|0.67|||Stratified Log-Rank Test|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).|Hazard ratio and its CI were estimated from Cox proportional hazard model adjusting for the stratification factors noted above.|||0.67|0.38|< 0.0001
70999441|NCT01938001|141505925|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.39|0.71|||Stratified Log Rank Test|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).||||0.71|0.39|<0.0001
71041785|NCT00407745|141592612|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.78|STANDARD_ERROR_OF_MEAN|3.492||0.0998|TWO_SIDED|95.0|-1.11|12.66||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline MOS - Sleep Adequacy as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||12.66|-1.11|0.0998
70999442|NCT01062009|141505950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|TWO_SIDED||||||Chi-squared|||Chi square analysis comparing number of participants with new fever in each group||||0.24
70923901|NCT04936035|141339822|SUPERIORITY||Difference in LS Mean|-14.2|STANDARD_ERROR_OF_MEAN|2.38|<|0.0001|TWO_SIDED|95.0|-18.9|-9.5||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM as a covariate.|MMRM|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||-9.5|-18.9|<0.0001
70923902|NCT04936035|141339823|SUPERIORITY||Difference in LS Mean|-12.1|STANDARD_ERROR_OF_MEAN|2.55|<|0.0001|TWO_SIDED|95.0|-17.2|-7.1||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with office SBP as a covariate.|MMRM|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||-7.1|-17.2|<0.0001
70923903|NCT04936035|141339823|SUPERIORITY||Difference in LS Mean|-10.2|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-15.1|-5.3||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with office SBP as a covariate.|MMRM|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||-5.3|-15.1|<0.0001
70923904|NCT04936035|141339824|SUPERIORITY||Odds Ratio (OR)|10.73|||<|0.0001|TWO_SIDED|95.0|3.76|30.64||Logistic regression model included treatment and race (black; all other races) as factors and baseline 24-hour mean SBP as a covariate|Regression, Logistic|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||30.64|3.76|<0.0001
70923905|NCT04936035|141339824|SUPERIORITY||Odds Ratio (OR)|17.93|||<|0.0001|TWO_SIDED|95.0|6.24|51.52||Logistic regression model included treatment and race (black; all other races) as factors and baseline 24-hour mean SBP as a covariate|Regression, Logistic|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||51.52|6.24|<0.0001
70999443|NCT01468701|141505953|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.6|0.9|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||0.90|0.60|
71041786|NCT00407745|141592613|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.7|STANDARD_ERROR_OF_MEAN|3.501||0.1048|TWO_SIDED|95.0|-1.2|12.61||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline MOS - Snoring as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||12.61|-1.20|0.1048
70999444|NCT01468701|141505955|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.63|0.98|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||0.98|0.63|
70999445|NCT01468701|141505956|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.57|1.11|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.11|0.57|
70999446|NCT01468701|141505958|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.57|1.14|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.14|0.57|
70999447|NCT01468701|141505966|OTHER||Hazard Ratio (HR)|0.52|||||TWO_SIDED|95.0|0.38|0.73|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous myocardial infarction, abnormal kidney function, concomitant antiplatelets use and concomitant use of drugs related to bleeding.||0.73|0.38|
70999448|NCT01468701|141505970|OTHER||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.6|1.57|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous myocardial infarction, concomitant antiplatelets use, concomitant use of drugs related to bleeding, hypertension, and diabetes.||1.57|0.60|
71041787|NCT00407745|141592614|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-5.14|STANDARD_ERROR_OF_MEAN|2.417||0.0347|TWO_SIDED|95.0|-9.91|-0.37||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included baseline MOS - Awaken Short of Breath or with headache as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-0.37|-9.91|0.0347
71100444|NCT02732145|141709664|EQUIVALENCE|Question: Is there a difference in the score for vulvar complaints (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for vulvar complaints (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
71100445|NCT02732145|141709664|EQUIVALENCE|Question: Is there a difference in the score for Marinoff Index (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9629|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for Marinoff Index (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9629
70999449|NCT01468701|141505972|OTHER||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.54|0.8|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||0.80|0.54|
70999450|NCT01068717|141505975|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric least squares (LS) mean|109.53|||||TWO_SIDED|90.0|102.67|116.85||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||116.85|102.67|
71008577|NCT02055976|141525228|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-73.879|STANDARD_ERROR_OF_MEAN|6.678|<|0.001|TWO_SIDED|95.0|-87.147|-60.612|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-60.612|-87.147|<0.001
71100446|NCT02732145|141709664|EQUIVALENCE|Question: Is there a difference in the score for the Cotton-Swab test (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9155|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the Cotton-Swab test (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9155
70923906|NCT03978871|141339879|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p = 0.05.|ANOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation). This is a test of between by within-subjects interaction effect.||||<0.001
70923907|NCT03978871|141339880|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.023|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation). This is a test of between by within-subjects interaction effect.||||0.023
70999451|NCT01068717|141505975|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|100.37|||||TWO_SIDED|90.0|85.7|117.56||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||117.56|85.70|
71008578|NCT02055976|141525228|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-95.428|STANDARD_ERROR_OF_MEAN|6.697||0.001|TWO_SIDED|95.0|-108.732|-82.124|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-82.124|-108.732|0.001
70923908|NCT03978871|141339880|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.034|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation). This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.034
70923909|NCT03978871|141339881|SUPERIORITY|The threshold for statistical significance was p = 0.0.5|||||<|0.001|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation). This is a test of between by within-subjects interaction effect.||||<.001
71100447|NCT02732145|141709664|EQUIVALENCE|Question: Is there a difference in the score for any lesion in any vulvar ring (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.4913|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any lesion in any vulvar ring (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.4913
71100448|NCT02732145|141709664|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Outer Vulvar Ring (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8866|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Outer Vulvar Ring (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8866
71100449|NCT02732145|141709664|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Middle Vulvar Ring (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Middle Vulvar Ring (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
71100450|NCT02732145|141709664|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Inner Vulvar Ring (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.3335|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Inner Vulvar Ring (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.3335
71100451|NCT02732145|141709664|EQUIVALENCE|Question: Is there a difference in the score for the specificity of vulvar lesions (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8666|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the specificity of vulvar lesions (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8666
71041788|NCT00407745|141592615|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.38|STANDARD_ERROR_OF_MEAN|0.189||0.0436|TWO_SIDED|95.0|0.01|0.76||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline MOS - Sleep Quantity as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.76|0.01|0.0436
71041789|NCT00407745|141592616|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.02|STANDARD_ERROR_OF_MEAN|2.77||0.2761|TWO_SIDED|95.0|-2.44|8.49||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline MOS - Somnolence as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||8.49|-2.44|0.2761
71041790|NCT00407745|141592617|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.81||||0.0024|TWO_SIDED|95.0|1.443|5.491||Significance was declared if p-value \<=0.05|Regression, Logistic|Logistic Regression Model included Pooled Center and Treatment as the categorical factors, and Optimal Sleep Score at Baseline as the covariate.||Null hypothesis - The rate of subjects with optimal sleep for the pregabain group was equal to the rate of subjects with optimal sleep for the placebo group; Alternative hypothesis - The rate of subjects with optimal sleep for the pregabain group was not equal to the rate of subjects with optimal sleep for the placebo group.||5.491|1.443|0.0024
71041791|NCT00407745|141592618|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.68|STANDARD_ERROR_OF_MEAN|0.433||0.1164|TWO_SIDED|95.0|-1.54|0.17||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline HADS - Anxiety as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.17|-1.54|0.1164
71041792|NCT00407745|141592619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.99|STANDARD_ERROR_OF_MEAN|0.447||0.0279|TWO_SIDED|95.0|-1.87|-0.11||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline HADS - Depression as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-0.11|-1.87|0.0279
71100452|NCT02732145|141709664|EQUIVALENCE|Question: Is there a difference in the score for non-specific vulvar lesions (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8666|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for non-specific vulvar lesions (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8666
71100453|NCT02732145|141709664|EQUIVALENCE|Question: Is there a difference in the score for specific vulvar lesions (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for specific vulvar lesions (median) with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
70923910|NCT03978871|141339881|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.002|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation). This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.002
70999452|NCT01068717|141505976|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|99.02|||||TWO_SIDED|90.0|91.29|107.41||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states||107.41|91.29|
70999453|NCT01068717|141505976|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|100.21|||||TWO_SIDED|90.0|96.86|103.67||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||103.67|96.86|
70999454|NCT01068717|141505978|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|102.34|||||TWO_SIDED|90.0|97.96|106.91||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||106.91|97.96|
70923911|NCT03978871|141339882|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.227|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education). This is a test of between-subjects effect.||||0.227
71008579|NCT02055976|141525228|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-104.859|STANDARD_ERROR_OF_MEAN|6.654|<|0.001|TWO_SIDED|95.0|-118.079|-91.639|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-91.639|-118.079|<0.001
71008580|NCT02055976|141525229|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-31.642|STANDARD_ERROR_OF_MEAN|2.717|<|0.001|TWO_SIDED|95.0|-37.039|-26.246|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-26.246|-37.039|<0.001
71008581|NCT02055976|141525229|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-39.88|STANDARD_ERROR_OF_MEAN|2.781|<|0.001|TWO_SIDED|95.0|-45.403|-34.358|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-34.358|-45.403|<0.001
71008582|NCT02055976|141525229|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-45.889|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-51.45|-40.329|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-40.329|-51.450|<0.001
71008583|NCT02055976|141525229|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-30.137|STANDARD_ERROR_OF_MEAN|3.006|<|0.001|TWO_SIDED|95.0|-36.11|-24.164|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-24.164|-36.110|<0.001
71008584|NCT02055976|141525229|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-39.525|STANDARD_ERROR_OF_MEAN|3.018|<|0.001|TWO_SIDED|95.0|-45.52|-33.531|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-33.531|-45.520|<0.001
71100454|NCT02732145|141709664|EQUIVALENCE|"Question: Is there a difference in the overall sum of points for the Vulvoscopy Index (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8144|||||||Wilcoxon (Mann-Whitney)|||"Parameter: The difference in the overall sum of points for the Vulvoscopy Index (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8144
70999455|NCT01068717|141505978|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|99.78|||||TWO_SIDED|90.0|96.61|103.05||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||103.05|96.61|
70999456|NCT01068717|141505983|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|102.34|||||TWO_SIDED|90.0|97.96|106.91||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||106.91|97.96|
70999457|NCT01068717|141505983|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|101.82|||||TWO_SIDED|90.0|96.1|107.88||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||107.88|96.10|
70999458|NCT01068717|141505984|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio (%) of geometric LS mean|102.64|||||TWO_SIDED|90.0|98.31|107.16||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||107.16|98.31|
70999459|NCT01068717|141505984|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio (%) of geometric LS mean|99.22||||||90.0|96.48|102.04||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||102.04|96.48|
70999460|NCT01068717|141505985|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|99.04|||||TWO_SIDED|95.0|92.9|105.59||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||105.59|92.90|
70999461|NCT01068717|141505985|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|102.77|||||TWO_SIDED|95.0|96.82|109.09||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||109.09|96.82|
70999462|NCT00892957|141505989|SUPERIORITY_OR_OTHER||||||<|0.0001|ONE_SIDED|95.0|||||Likelihood ratio chi-square test|||||||<0.0001
70999463|NCT00892957|141505990|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|95.0|||||Likelihood ratio chi-square test|||||||0.001
70999464|NCT00892957|141505991|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|95.0|||||Likelihood ratio chi-square test|||||||0.012
70999465|NCT00892957|141505992|SUPERIORITY_OR_OTHER|||||||0.158|TWO_SIDED|95.0|||||Likelihood ratio chi-square test|||||||0.158
70999466|NCT00892957|141505994|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED|95.0|||||Likelihood ratio chi-square test|||||||0.380
70999467|NCT00892957|141505995|SUPERIORITY_OR_OTHER|||||||0.545|TWO_SIDED|95.0|||||Likelihood ratio chi-square test|||||||0.545
70999468|NCT02688153|141506033|SUPERIORITY||Median Difference (Final Values)|-4.5||||0.366|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.3660
70999469|NCT02688153|141506034|SUPERIORITY||Median Difference (Final Values)|2.0||||0.8377|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.8377
70999470|NCT01135394|141506062|OTHER|The genes with p-values below 10\^-6 were identified|Pearson correlation p-value|0.0000001|||<|1e-07|TWO_SIDED|||||The genes with p-values below 10\^-6 were identified|Genes with p-values below 10^-6|||After the change (end-of-treatment minus baseline) in HOMA-IR index had been calculated for each subject, the change (end-of-treatment minus baseline) in expression of each of approximately 45,000 transcripts contained in a human gene array was calculated. A Pearson correlation p-value was calculated for the correlation between change in gene expression and change in HOMA-IR index, with the purpose of identifying the genes whose expression changed in concert with changes in HOMA-IR index.|The genes with P-values below 10\^-6 were identified|||<0.0000001
70999471|NCT00191386|141506065|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Total Score 6 Months|Paired t-test|||||||<0.001
70999472|NCT00191386|141506065|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Total Score 12 Months|Paired t-test|||||||<0.001
70999473|NCT00191386|141506065|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Total Score 2 Years.|Paired t-test|||||||<0.001
71041793|NCT00108082|141592620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.7651||95.0|-1.83|2.49|||ANCOVA|||The null hypotheses (tested hierarchically) were that the effect of carvedilol CR + lisinopril on LV mass regression was no different than the effect of atenolol + lisinopril, and that the effect of carvedilol CR + lisinopril was no different than the effect of lisinopril + lisinopril. The primary analysis was based on an analysis of covariance (ANCOVA) with a model adjusting for treatment, stratification by hypertension class, region, and baseline value, at a 0.05 level of significance.||2.49|-1.83|0.7651
71041794|NCT00108082|141592620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.1711||95.0|-0.7|3.9|||ANCOVA|||||3.90|-0.70|0.1711
71041795|NCT00955552|141592640|NON_INFERIORITY|Non-inferiority test of Ártico vs Cosamin DS® regarding the decrease of pain scale (VAS) in the PP population (N = 86).|||||<|0.05||||||For numeric variables Test -t student or ANOVA will be used. It will be considered statistically significant P-value less than 0,05.|t-test, 1 sided|||||||<0.05
71041796|NCT00412737|141592665|SUPERIORITY_OR_OTHER||Relative Risk Reduction|0.283||||0.772|TWO_SIDED|95.0|-2.3|4.1|||Fisher Exact||Relative Risk Reduction = (1.0 - Relative Risk).|The null hypothesis tested was that there was no difference between the proportions of participants who met the primary endpoint in the two treatment groups.||4.1|-2.3|0.772
71041797|NCT00412737|141592666|SUPERIORITY_OR_OTHER||Relative Risk Reduction|0.37||||0.534|TWO_SIDED|95.0|-2.1|4.5|||Fisher Exact||Relative Risk Reduction = (1.0 - Relative Risk).|||4.5|-2.1|0.534
71041798|NCT00412737|141592667|SUPERIORITY_OR_OTHER||Relative Risk Reduction|0.431||||0.381|TWO_SIDED|95.0|-1.7|4.6|||Fisher Exact||Relative Risk Reduction = (1.0 - Relative Risk).|||4.6|-1.7|0.381
71041799|NCT00412737|141592668|SUPERIORITY_OR_OTHER||Relative Risk Reduction|0.713|||||TWO_SIDED|95.0|-0.6|5.2|||||Relative Risk Reduction = (1.0 - Relative Risk).|||5.2|-0.6|
71041800|NCT00412737|141592669|SUPERIORITY_OR_OTHER||Slope|0.858|||||TWO_SIDED|95.0|0.1|5.7|||||Relative Risk Reduction = (1.0 - Relative Risk).|||5.7|0.1|
71041801|NCT00412737|141592670|SUPERIORITY_OR_OTHER||Relative Risk Reduction|0.372|||||TWO_SIDED|95.0|-1.9|4.6|||||Relative Risk Reduction = (1.0 - Relative Risk).|||4.6|-1.9|
71041802|NCT00412737|141592671|SUPERIORITY_OR_OTHER||Relative Risk Reduction|0.502|||||TWO_SIDED|95.0|-1.4|5.1|||||Relative Risk Reduction = (1.0 - Relative Risk).|||5.1|-1.4|
70999474|NCT00191386|141506065|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Total Score 3 Years.|Paired t-test|||||||<0.001
70999475|NCT00191386|141506065|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Total Score 4 Years.|Paired t-test|||||||<0.001
70999476|NCT00191386|141506066|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 6 Months.|Paired t-test|||||||<0.001
70999477|NCT00191386|141506066|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 12 Months.|Paired t-test|||||||<0.001
70999478|NCT00191386|141506066|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 2 Years.|Paired t-test|||||||<0.001
70999479|NCT00191386|141506066|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 3 Years.|Paired t-test|||||||<0.001
70999480|NCT00191386|141506066|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 4 Years.|Paired t-test|||||||<0.001
70999481|NCT02061748|141506082|SUPERIORITY_OR_OTHER|||||||0.0111|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0111
70999482|NCT02061748|141506083|SUPERIORITY_OR_OTHER|||||||0.0861|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0861
71100455|NCT02732145|141709665|EQUIVALENCE|Question: Is there a difference in the score for vulvar complaints in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.5403|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for vulvar complaints (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.5403
71100456|NCT02732145|141709665|EQUIVALENCE|Question: Is there a difference in the score for Marinoff Index in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9248|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for Marinoff Index (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9248
70999483|NCT02061748|141506084|SUPERIORITY_OR_OTHER|||||||0.0011|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0011
70999484|NCT02061748|141506085|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0019
71041803|NCT00513617|141592700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1254|STANDARD_ERROR_OF_MEAN|0.0705||0.08||||||Alpha was set at 0.05|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo was subtracted from the Low dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.||||0.080
71041804|NCT00513617|141592700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.098|STANDARD_ERROR_OF_MEAN|0.0713||0.133||||||Alpha was set at 0.05|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo was subtracted from High dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.||||0.133
71041805|NCT00513617|141592702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1826|STANDARD_ERROR_OF_MEAN|0.0713||0.915||||||Alpha was set at 0.5|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo subtracted from Low dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.||||0.915
71041806|NCT00513617|141592702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3582|STANDARD_ERROR_OF_MEAN|4.1047||0.918||||||Alpha was set at 0.05|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo subtracted from High dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.||||0.918
71041807|NCT00513617|141592703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7867|STANDARD_ERROR_OF_MEAN|1.1101||0.015||||||Alpha was set at 0.05|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo subtracted from Low dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.||||0.015
71041808|NCT00513617|141592703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5213|STANDARD_ERROR_OF_MEAN|1.1553||0.557||||||Alpha was set at 0.05|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo subtracted from High dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.||||0.557
71041809|NCT03449199|141592707|SUPERIORITY||LS Mean Difference|-0.05||||0.7953|TWO_SIDED|95.0|-0.44|0.34|||ANCOVA|||Change from baseline in log-transformed UACR was analyzed using an ANCOVA model with randomized treatment, and randomization strata of sUA and UACR as independent variables. The last observation carried forward imputation was used for missing data. In this study, multiplicity was not considered since the study objective is exploratory.||0.34|-0.44|0.7953
71041810|NCT03449199|141592707|SUPERIORITY||LS Mean Difference|-0.43||||0.0311|TWO_SIDED|95.0|-0.82|-0.04|||ANCOVA|||Change from baseline in log-transformed UACR was analyzed using an ANCOVA model with randomized treatment, and randomization strata of sUA and UACR as independent variables. The last observation carried forward imputation was used for missing data. In this study, multiplicity was not considered since the study objective is exploratory.||-0.04|-0.82|0.0311
71041811|NCT03449199|141592708|SUPERIORITY||LS Mean Difference|1.71||||0.4055|TWO_SIDED|95.0|-2.35|5.78|||ANCOVA|||For Week 12 (visit of the primary outcome), ANCOVA model with treatment, randomization strata of sUA and UACR levels as independent variables, Baseline eGFR as covariate is fitted. The last observation carried forward imputation was used for missing data.||5.78|-2.35|0.4055
71041812|NCT03449199|141592708|SUPERIORITY||LS Mean Difference|3.42||||0.096|TWO_SIDED|95.0|-0.62|7.46|||ANCOVA|||For Week 12 (visit of the primary outcome), an ANCOVA model with treatment, randomization strata of sUA and UACR levels as independent variables, Baseline eGFR as covariate is fitted. The last observation carried forward imputation was used for missing data.||7.46|-0.62|0.0960
71041813|NCT03449199|141592709|SUPERIORITY||LS Mean Difference|-2.43|||<|0.0001|TWO_SIDED|95.0|-3.13|-1.74|||ANCOVA|||For Week 12 (visit of the primary outcome), an ANCOVA model with treatment, randomization strata of UACR levels as independent variables is fitted. The last observation carried forward imputation was used for missing data.||-1.74|-3.13|<0.0001
71041814|NCT03449199|141592709|SUPERIORITY||LS Mean Difference|-3.23|||<|0.0001|TWO_SIDED|95.0|-3.91|-2.54|||ANCOVA|||For Week 12 (visit of the primary outcome), an ANCOVA model with treatment, randomization strata of UACR levels as independent variables is fitted. The last observation carried forward imputation was used for missing data.||-2.54|-3.91|<0.0001
70999485|NCT02061748|141506086|SUPERIORITY_OR_OTHER|||||||0.0808|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0808
70999486|NCT02061748|141506087|SUPERIORITY_OR_OTHER|||||||0.3502|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.3502
70999487|NCT02061748|141506088|SUPERIORITY_OR_OTHER|||||||0.0068|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0068
70999488|NCT02061748|141506089|SUPERIORITY_OR_OTHER|||||||0.0271|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0271
70999489|NCT02061748|141506090|SUPERIORITY_OR_OTHER|||||||0.0749|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0749
70999490|NCT02061748|141506091|SUPERIORITY_OR_OTHER|||||||0.0072|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0072
70999491|NCT02061748|141506092|SUPERIORITY_OR_OTHER|||||||0.0055|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0055
70999492|NCT02061748|141506093|SUPERIORITY_OR_OTHER|||||||0.0284|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0284
70999493|NCT02061748|141506094|SUPERIORITY_OR_OTHER|||||||0.907|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.907
70999494|NCT02061748|141506095|SUPERIORITY_OR_OTHER|||||||0.8208|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.8208
70999495|NCT02061748|141506096|SUPERIORITY_OR_OTHER|||||||0.1534|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.1534
70999496|NCT02061748|141506097|SUPERIORITY_OR_OTHER|||||||0.3055|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.3055
70999497|NCT02061748|141506098|SUPERIORITY_OR_OTHER|||||||0.9573|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.9573
70999498|NCT02061748|141506099|SUPERIORITY_OR_OTHER|||||||0.8465|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.8465
71041815|NCT03449199|141592710|SUPERIORITY||LS Mean Difference|-102.02||||0.3955|TWO_SIDED|95.0|-338.81|134.78|||ANCOVA|||For Week 12 (visit of the primary outcome), an ANCOVA model with treatment, randomization strata of UACR levels as independent variables is fitted. The last observation carried forward imputation was used for missing data.||134.78|-338.81|0.3955
71041816|NCT03449199|141592710|SUPERIORITY||LS Mean Difference|-197.49||||0.0991|TWO_SIDED|95.0|-432.73|37.75|||ANCOVA|||For Week 12 (visit of the primary outcome), ANCOVA model with treatment, randomization strata of UACR levels as independent variables is fitted. The last observation carried forward imputation was used for missing data.||37.75|-432.73|0.0991
70999499|NCT02061748|141506100|SUPERIORITY_OR_OTHER|||||||0.0006|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0006
70999500|NCT02061748|141506101|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||<0.0001
70999501|NCT02061748|141506102|SUPERIORITY_OR_OTHER|||||||0.0185|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0185
70999502|NCT02061748|141506103|SUPERIORITY_OR_OTHER|||||||0.0138|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0138
70999503|NCT02061748|141506104|SUPERIORITY_OR_OTHER|||||||0.261|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.261
70999504|NCT02061748|141506105|SUPERIORITY_OR_OTHER|||||||0.4407|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.4407
70999505|NCT02061748|141506106|SUPERIORITY_OR_OTHER|||||||0.2665|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.2665
71100457|NCT02732145|141709665|EQUIVALENCE|Question: Is there a difference in the score for the Cotton-Swab test in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9839|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the Cotton-Swab test (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9839
70999506|NCT02061748|141506107|SUPERIORITY_OR_OTHER|||||||0.8017|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.8017
70999507|NCT02061748|141506108|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||<0.0001
70999508|NCT02061748|141506109|SUPERIORITY_OR_OTHER|||||||0.2083|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.2083
70999509|NCT02061748|141506110|SUPERIORITY_OR_OTHER|||||||0.0023|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0023
70999510|NCT02061748|141506111|SUPERIORITY_OR_OTHER|||||||0.5331|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.5331
70999511|NCT02061748|141506112|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0003
70999512|NCT02061748|141506113|SUPERIORITY_OR_OTHER|||||||0.2646|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.2646
70999513|NCT02061748|141506114|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0004
70999514|NCT02061748|141506115|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0004
70999515|NCT03706040|141506124|SUPERIORITY||Adjusted Difference|13.0||||0.084|TWO_SIDED|95.0|-1.7|27.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||27.7|-1.7|0.084
70999516|NCT03706040|141506124|SUPERIORITY||Adjusted Difference|10.0||||0.179|TWO_SIDED|95.0|-4.6|24.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||24.6|-4.6|0.179
70999517|NCT03706040|141506125|SUPERIORITY||Adjusted Difference|8.7||||0.129|TWO_SIDED|95.0|-2.5|20.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||20.0|-2.5|0.129
70999518|NCT03706040|141506125|SUPERIORITY||Adjusted Difference|0.0||||0.994|TWO_SIDED|95.0|-9.4|9.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||9.4|-9.4|0.994
70999519|NCT03706040|141506126|SUPERIORITY||Adjusted Difference|13.7||||0.001|TWO_SIDED|95.0|5.4|22.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||22.1|5.4|0.001
70999520|NCT03706040|141506126|SUPERIORITY||Adjusted Difference|15.3|||<|0.001|TWO_SIDED|95.0|6.6|24.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||24.0|6.6|<0.001
71041817|NCT03449199|141592711|SUPERIORITY||Odds Ratio (OR)|1.72||||0.2791|TWO_SIDED||||||Regression, Logistic||Missing observations at Study Week 12 are imputed as nonresponse.|Odds ratio, 95% CLs, and p-values are obtained from logistic regression model adjusting for treatment group, randomization strata of Baseline sUA (\<6.0 vs ≥6.0 mg/dL) and Baseline UACR (200 to \<300 mg/g vs 300 to ≤3000 mg/g), Baseline UACR and Baseline sUA levels. Odds ratio for a baseline covariate is the ratio of odds over one unit increase of the covariate and it is assumed constant. P-value represents the statistical significance level of odds ratio differing from 1.||||0.2791
71041818|NCT03449199|141592711|SUPERIORITY||Odds Ratio (OR)|2.57||||0.0507|TWO_SIDED||||||Regression, Logistic|||Odds ratio, 95% CLs, and p-values are obtained from logistic regression model adjusting for treatment group, randomization strata of Baseline sUA (\<6.0 vs ≥6.0 mg/dL) and Baseline UACR (200 to \<300 mg/g vs 300 to ≤3000 mg/g), Baseline UACR and Baseline sUA levels. Odds ratio for a baseline covariate is the ratio of odds over one unit increase of the covariate and it is assumed constant. P-value represents the statistical significance level of odds ratio differing from 1.||||0.0507
71041819|NCT01091103|141592721|SUPERIORITY_OR_OTHER|||||||0.9427|TWO_SIDED|||||The p-value was not adjusted for multiplicity.|t-test, 2 sided|||||||0.9427
70999521|NCT03706040|141506127|SUPERIORITY||Least Squares (LS) Mean Difference|-10.32|STANDARD_ERROR_OF_MEAN|11.073||0.353|TWO_SIDED|95.0|-32.25|11.61|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||11.61|-32.25|0.353
71041820|NCT01091103|141592722|SUPERIORITY_OR_OTHER|||||||0.337|TWO_SIDED|||||The p-value was not adjusted for multiplicity.|t-test, 2 sided|||||||0.3370
71041821|NCT03404401|141592762|NON_INFERIORITY|Non-inferiority margin was set at 10%.|||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70999522|NCT03706040|141506127|SUPERIORITY||LS Mean Difference|-16.86|STANDARD_ERROR_OF_MEAN|11.305||0.139|TWO_SIDED|95.0|-39.24|5.53|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||5.53|-39.24|0.139
70999523|NCT03706040|141506130|SUPERIORITY||Adjusted Difference|12.9||||0.171|TWO_SIDED|95.0|-5.6|31.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||31.4|-5.6|0.171
70999524|NCT03706040|141506130|SUPERIORITY||Adjusted Difference|5.7||||0.552|TWO_SIDED|95.0|-13.1|24.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||24.5|-13.1|0.552
70999525|NCT03706040|141506132|SUPERIORITY||Adjusted Difference|11.6||||0.022|TWO_SIDED|95.0|1.7|21.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||21.6|1.7|0.022
70999526|NCT03706040|141506132|SUPERIORITY||Adjusted Difference|5.8||||0.192|TWO_SIDED|95.0|-2.9|14.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||14.4|-2.9|0.192
71041822|NCT00988208|141592767|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.53||||0.0017|TWO_SIDED|95.0|1.17|2.0||p-value is based on unstratified log-rank test|Log Rank|||||2.00|1.17|0.0017
70999527|NCT03706040|141506135|SUPERIORITY||LS Mean Difference|-6.24|STANDARD_ERROR_OF_MEAN|4.506||0.169|TWO_SIDED|95.0|-15.15|2.68|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||2.68|-15.15|0.169
70999528|NCT03706040|141506135|SUPERIORITY||LS Mean Difference|-5.86|STANDARD_ERROR_OF_MEAN|4.589||0.204|TWO_SIDED|95.0|-14.94|3.22|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||3.22|-14.94|0.204
70999529|NCT03706040|141506137|SUPERIORITY||Adjusted Difference|6.7||||0.422|TWO_SIDED|95.0|-9.7|23.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||23.1|-9.7|0.422
70999530|NCT03706040|141506137|SUPERIORITY||Adjusted Difference|-5.2||||0.505|TWO_SIDED|95.0|-20.3|10.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||10.0|-20.3|0.505
70999531|NCT03706040|141506139|SUPERIORITY||Adjusted Difference|10.1||||0.005|TWO_SIDED|95.0|3.0|17.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||17.3|3.0|0.005
70999532|NCT03706040|141506139|SUPERIORITY||Adjusted Difference|2.9||||0.151|TWO_SIDED|95.0|-1.1|6.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||6.8|-1.1|0.151
70999533|NCT03706040|141506141|SUPERIORITY||Adjusted Difference|5.9||||0.035|TWO_SIDED|95.0|0.4|11.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||11.3|0.4|0.035
70999534|NCT03706040|141506141|SUPERIORITY||Adjusted Difference|1.5||||0.311|TWO_SIDED|95.0|-1.4|4.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||4.4|-1.4|0.311
70999535|NCT03706040|141506143|SUPERIORITY||Adjusted Difference|-0.3||||0.965|TWO_SIDED|95.0|-12.0|11.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||11.5|-12.0|0.965
70999536|NCT03706040|141506143|SUPERIORITY||Adjusted Difference|-3.1||||0.583|TWO_SIDED|95.0|-14.3|8.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||8.1|-14.3|0.583
70999537|NCT03706040|141506147|SUPERIORITY||Adjusted Difference|5.9||||0.539|TWO_SIDED|95.0|-13.0|24.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||24.9|-13.0|0.539
70999538|NCT03706040|141506147|SUPERIORITY||Adjusted Difference|12.2||||0.213|TWO_SIDED|95.0|-7.0|31.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||31.5|-7.0|0.213
70999539|NCT03706040|141506149|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.82||0.988|TWO_SIDED|95.0|-3.6|3.6|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||3.6|-3.6|0.988
70999540|NCT03706040|141506149|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.86||0.594|TWO_SIDED|95.0|-4.7|2.7|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||2.7|-4.7|0.594
70999541|NCT03706040|141506153|SUPERIORITY||LS Mean Difference|-1.318|STANDARD_ERROR_OF_MEAN|0.6137||0.033|TWO_SIDED|95.0|-2.531|-0.105|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||-0.105|-2.531|0.033
70999542|NCT03706040|141506153|SUPERIORITY||LS Mean Difference|-1.648|STANDARD_ERROR_OF_MEAN|0.626||0.009|TWO_SIDED|95.0|-2.885|-0.411|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||-0.411|-2.885|0.009
70999543|NCT00439725|141506157|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.185|STANDARD_ERROR_OF_MEAN|0.3858|<|0.0001||95.0|0.087|0.393||1st test in a hierarchy, a p-value of less than 0.05 would be considered significant.|Regression, Cox|Stratified by intended treatment duration, adjusted for pre-treatment||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (confidence interval) (two-sided testing).||0.393|0.087|< 0.0001
71041823|NCT00988208|141592768|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.0187|TWO_SIDED|95.0|1.05|1.66|||Log Rank|P-value is based on unstratified log-rank test||||1.66|1.05|0.0187
71041824|NCT00988208|141592769|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.884||||0.3975|TWO_SIDED|95.0|0.665|1.176|||Chi-squared|||||1.176|0.665|0.3975
71041825|NCT03008837|141592777|OTHER|Using seed-based analysis with a right posterior insula seed, cluster size was set at 40 voxels, and p-value was thresholded at p\<0.05 to compare the differences between the two groups in terms of connectivity between the right posterior insula and areas of the DMN identified based on a priori hypotheses.|Mean Difference (Final Values)|40.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided||Standard therapy control (post-pre) was subtracted from PENFS (post-pre).|PENFS (post-pre) - Standard Therapy (post-pre)||||<0.05
70999544|NCT00439725|141506158|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.18|STANDARD_ERROR_OF_MEAN|0.385|<|0.0001||95.0|0.085|0.383||2nd test in a hierarchy, a p-value of less than 0.05 would be considered significant. If the 1st test in hierarchy was significant.|Regression, Cox|Stratified by intended treatment duration, adjusted for pre-treatment||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (two-sided testing).||0.383|0.085|< 0.0001
70999545|NCT00439725|141506159|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.198|STANDARD_ERROR_OF_MEAN|0.3659|<|0.0001||95.0|0.096|0.405||3rd test in a hierarchy, a p-value of less than 0.05 would be considered significant. If the previous tests in hierarchy were significant|Regression, Cox|Stratified by intended treatment duration, adjusted for pre-treatment||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (two-sided testing).||0.405|0.096|< 0.0001
70999546|NCT00439725|141506160|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.278|STANDARD_ERROR_OF_MEAN|0.3274|<|0.0001||95.0|0.146|0.528||4th test in a hierarchy, a p-value of less than 0.05 would be considered significant. If the previous tests in hierarchy were significant|Regression, Cox|Stratified by intended treatment duration, adjusted for pre-treatment||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (two-sided testing).||0.528|0.146|< 0.0001
70999547|NCT00439725|141506163|SUPERIORITY_OR_OTHER|||||||0.1121||||||No adjustment for multiple comparison.|Log Rank|||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (two-sided testing), comparison was done for the treatment emergent (within two days after end of treatment) bleeding events.||||0.1121
70999548|NCT00439725|141506164|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.185|STANDARD_ERROR_OF_MEAN|0.4131|<|0.0001||95.0|2.307|11.652||No adjustment for multiple comparison, a p-value of less than 0.05 would be considered significant.|Regression, Cox|Stratified by intended treatment duration, adjusted for pre-treatment done for treatment-emergent (time window: 2 days)||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (two-sided testing), comparison was done for the treatment emergent (within two days after end of treatment) bleeding events.||11.652|2.307|< 0.0001
70999549|NCT03788616|141506177|EQUIVALENCE|assuming 95% power of the study|Median Difference (Final Values)|0.05||||0.478|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.478
70999550|NCT02940860|141506186|NON_INFERIORITY|Non-inferiority could be claimed if the lower bound of the 95% confidence interval (CI) was above -0.5 g/dL.|Mean Difference (Final Values)|0.08|||||TWO_SIDED|95.0|-0.06|0.23|||||The Mixed Model for Repeated Measurement (MMRM) used for testing, included the fixed, categorical effects of treatment, week, treatment-by-week interaction, strata, and the continuous covariates of baseline Hb and baseline Hb-by-week interaction.|"Power:~With N=1000 subjects in the iron isomaltoside/ferric derisomaltose treatment group and with N=500 subjects in the iron sucrose treatment group, assuming no difference between the treatment groups and assuming a common standard deviation (SD) of 1.5 g/dL, the power was 100% for demonstrating non-inferiority of the change in Hb from baseline to week 8, using a non-inferiority margin of -0.5 g/dL.~The significance level was set to 5%."||0.23|-0.06|
70999551|NCT02940860|141506187|OTHER||95% two-sided CI (iron isomaltoside)|0.3|||||TWO_SIDED|95.0|0.06|0.86||||||"Power:~With N=1000 subjects in the iron isomaltoside/ferric derisomaltose, the power was 88% to demonstrate that the upper bound of the 95% CI of the incidence of treatment-emergent serious and/or severe non-serious hypersensitivity AEs was less than 3%.~The significance level was set to 5%."||0.86|0.06|
70999552|NCT02940860|141506187|OTHER||Risk Difference (RD)|0.29|||||TWO_SIDED|95.0|-0.19|0.77||||||Risk difference between iron isomaltoside/ferric derisomaltose and iron sucrose was assessed for the individual trial with 95% Newcombe CI adjusted for stratum using the Cochran-Mantel-Haenszel method.||0.77|-0.19|
70999553|NCT02940860|141506187|NON_INFERIORITY|Non-inferiority can be claimed if the upper bound of the 95% CI is below 1.5 % point.|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.57|0.48||||||Risk difference between iron isomaltoside/ferric derisomaltose and iron sucrose was assessed for the pooled FERWON-IDA and FERWON-NEPHRO trials (2008 subjects treated with iron isomaltoside/ferric derisomaltose and 1000 subjects treated with iron sucrose) with 95% Newcombe CI adjusted for stratum using the Cochran-Mantel-Haenszel method.||0.48|-0.57|
70999554|NCT02940860|141506188|SUPERIORITY|||||||0.0248|||||||Fisher Exact|||Adjudicated and confirmed treatment-emergent composite cardiovascular AEs. Any treatment emergent composite cardiovascular AEs were included in the statistical evaluation. The overall incidence of adjudicated and confirmed composite cardiovascular AEs was tabulated and compared between the treatment groups by a Fisher's exact test.||||0.0248
70999555|NCT02940860|141506189|SUPERIORITY|||||||0.0185|||||||Log Rank|||The time to first adjudicated and confirmed composite cardiovascular AEs was estimated using the Kaplan-Meier method and the hypothesis of no treatment difference was assessed by a log-rank test.||||0.0185
70999556|NCT02940860|141506191|SUPERIORITY||Odds Ratio (OR)|1.37||||0.0478|TWO_SIDED|95.0|1.0|1.87|||Repeated measures logistic regressioin|||"Week 1~Hb increase of ≥1 g/dL from baseline to week 1.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||1.87|1.00|0.0478
70999557|NCT02940860|141506191|SUPERIORITY||Odds Ratio (OR)|1.81|||<|0.0001|TWO_SIDED|95.0|1.39|2.36|||Repeated measures logistic regressioin|||"Week 2~Hb increase of ≥1 g/dL from baseline to week 2.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||2.36|1.39|<0.0001
70999558|NCT02940860|141506191|SUPERIORITY||Odds Ratio (OR)|1.41||||0.0048|TWO_SIDED|95.0|1.11|1.79|||Repeated measures logistic regressioin|||"Week 4~Hb increase of ≥1 g/dL from baseline to week 4.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||1.79|1.11|0.0048
70999559|NCT02940860|141506191|SUPERIORITY||Odds Ratio (OR)|1.01||||0.944|TWO_SIDED|95.0|0.8|1.27|||Repeated measures logistic regressioin|||"Week 8~Hb increase of ≥1 g/dL from baseline to week 8.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||1.27|0.80|0.9440
70999560|NCT02940860|141506192|SUPERIORITY|||||||0.0174|||||||Log Rank|||Time to Hb response was estimated using the Kaplan-Meier method and the hypothesis of no treatment difference was assessed by a 2-sided log-rank test.||||0.0174
71100458|NCT02732145|141709665|EQUIVALENCE|Question: Is there a difference in the score for any lesion in any vulvar ring (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.5124|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any lesion in any vulvar ring (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.5124
70923912|NCT03978871|141339883|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.272|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect for accuracy (Growth Mindset vs. Brain Education). This is a test of between-subjects effect.||||0.272
71100459|NCT02732145|141709665|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.2058|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Outer Vulvar Ring (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.2058
70999561|NCT02940860|141506193|SUPERIORITY||Odds Ratio (OR)|1.1||||0.5074|TWO_SIDED|95.0|0.83|1.45|||Regression, Logistic|||The proportion of subjects who achieved a Hb level of \>12 g/dL at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects. The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose is presented with 95% CI and corresponding p-value.||1.45|0.83|0.5074
70999562|NCT02940860|141506194|SUPERIORITY||Odds Ratio (OR)|1.24||||0.1035|TWO_SIDED|95.0|0.96|1.6|||Regression, Logistic|||"The proportion of subjects who achieved an increase in Hb concentration ≥2 g/dL at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects.~The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose was presented with 95% CI and corresponding p-value."||1.60|0.96|0.1035
70999563|NCT02940860|141506195|SUPERIORITY||Odds Ratio (OR)|1.82|||<|0.0001|TWO_SIDED|95.0|1.38|2.4|||Regression, Logistic|||"Proportion of subject who achieved a s-ferritin level of ≥100 ng/mL AND a TSAT of 20-50% at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects.~The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose is presented with 95% CI and corresponding p-value."||2.40|1.38|<0.0001
70999564|NCT02940860|141506196|SUPERIORITY||Mean Difference (Final Values)|0.22|||<|0.0001|TWO_SIDED|95.0|0.12|0.31|||Mixed model for repeated measures|||"Week 1~Change in Hb concentration from baseline to week 1 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."||0.31|0.12|<0.0001
70999565|NCT02940860|141506196|SUPERIORITY||Mean Difference (Final Values)|0.25|||<|0.0001|TWO_SIDED|95.0|0.14|0.36|||Mixed model for repeated measures|||"Week 2~Change in Hb concentration from baseline to week 2 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."||0.36|0.14|<0.0001
70999566|NCT02940860|141506196|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.0208|TWO_SIDED|95.0|0.02|0.28|||Mixed model for repeated measures|||"Week 4~Change in Hb concentration from baseline to week 4 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."||0.28|0.02|0.0208
70999567|NCT02940860|141506197|SUPERIORITY||Mean Difference (Final Values)|309.2|||<|0.0001|TWO_SIDED|95.0|280.7|337.8|||Mixed model for repeated measures|||"Week 1~Change in concentrations of s-ferritin from baseline to week 1 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||337.8|280.7|<0.0001
70999568|NCT02940860|141506197|SUPERIORITY||Mean Difference (Final Values)|95.8|||<|0.0001|TWO_SIDED|95.0|67.9|123.7|||Mixed model for repeated measures|||"Week 2~Change in concentrations of s-ferritin from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||123.7|67.9|<0.0001
70923913|NCT03978871|141339884|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.217|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education) for the ERS emotion regulation involuntary dysregulation subscale post psycho-educational lesson. This is a test of between-subjects effect.||||0.217
70999569|NCT02940860|141506197|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.7834|TWO_SIDED|95.0|-21.2|28.1|||Mixed model for repeated measures|||"Week 4~Change in concentrations of s-ferritin from baseline to week 4 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||28.1|-21.2|0.7834
70999570|NCT02940860|141506197|SUPERIORITY||Mean Difference (Final Values)|3.3||||0.7621|TWO_SIDED|95.0|-18.1|24.7|||Mixed model for repeated measures|||"Week 8~Change in concentrations of s-ferritin from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||24.7|-18.1|0.7621
70999571|NCT02940860|141506198|SUPERIORITY||Mean Difference (Final Values)|8.8|||<|0.0001|TWO_SIDED|95.0|6.9|10.7|||Mixed model for repeated measures|||"Week 1~Change in TSAT from baseline to week 1 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||10.7|6.9|<0.0001
70999572|NCT02940860|141506198|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.0129|TWO_SIDED|95.0|0.3|2.4|||Mixed model for repeated measures|||"Week 2~Change in TSAT from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||2.4|0.3|0.0129
70999573|NCT02940860|141506198|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.2403|TWO_SIDED|95.0|-0.4|1.5|||Mixed model for repeated measures|||"Week 4~Change in TSAT from baseline to week 4 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||1.5|-0.4|0.2403
70999574|NCT02940860|141506198|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.8094|TWO_SIDED|95.0|-0.9|1.2|||Mixed model for repeated measures|||"Week 8~Change in TSAT from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||1.2|-0.9|0.8094
70999575|NCT02940860|141506199|SUPERIORITY||Mean Difference (Final Values)|26.5|||<|0.0001|TWO_SIDED|95.0|20.4|32.7|||Mixed model for repeated measures|||"Week 1~Change in s-iron from baseline to week 1 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by week interaction effects are presented by week, including 95% CIs and corresponding p-value."||32.7|20.4|<0.0001
70999576|NCT02940860|141506199|SUPERIORITY||Mean Difference (Final Values)|1.9||||0.2229|TWO_SIDED|95.0|-1.2|5.1|||Mixed model for repeated measures|||"Week 2~Change in s-iron from baseline to week 2 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by week interaction effects are presented by week, including 95% CIs and corresponding p-value."||5.1|-1.2|0.2229
70999577|NCT02940860|141506199|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.9046|TWO_SIDED|95.0|-2.9|2.6|||Mixed model for repeated measures|||"Week 4~Change in s-iron from baseline to week 4 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by week interaction effects are presented by week, including 95% CIs and corresponding p-value."||2.6|-2.9|0.9046
70999578|NCT02940860|141506199|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.1307|TWO_SIDED|95.0|-5.8|0.8|||Mixed model for repeated measures|||"Week 8~Change in s-iron from baseline to week 8 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by week interaction effects are presented by week, including 95% CIs and corresponding p-value."||0.8|-5.8|0.1307
70999579|NCT02940860|141506200|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.8196|TWO_SIDED|95.0|-0.73|0.92|||Mixed model for repeated measures|||"Week 1~Change in fatigue symptoms score from baseline to week 1 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."||0.92|-0.73|0.8196
71100460|NCT02732145|141709665|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.6412|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Middle Vulvar Ring (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.6412
71100461|NCT02732145|141709665|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9753|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Inner Vulvar Ring (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9753
70999580|NCT02940860|141506200|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.7132|TWO_SIDED|95.0|-1.06|0.73|||Mixed model for repeated measures|||"Week 2~Change in fatigue symptoms score from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."||0.73|-1.06|0.7132
70999581|NCT02940860|141506200|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.586|TWO_SIDED|95.0|-0.71|1.25|||Mixed model for repeated measures|||"Week 8~Change in fatigue symptoms score from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."||1.25|-0.71|0.5860
70999582|NCT04914819|141506206|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.048|TWO_SIDED|95.0|0.04|10.8|||Mixed Models Analysis|||Change in weight among participants who completed final assessment||10.8|0.04|0.048
70999583|NCT04914819|141506207|SUPERIORITY|||||||0.3|||||||Chi-squared|||||||0.3
70999584|NCT04914819|141506208|SUPERIORITY|||||||0.331|||||||Chi-squared|||||||0.331
70999585|NCT04914819|141506209|SUPERIORITY|||||||0.734|||||||Fisher Exact|||||||0.734
70999586|NCT04038385|141506221|SUPERIORITY||Mean Difference (Net)|-42.87||||0.001|TWO_SIDED|95.0|-65.25|-20.49|||Mixed Models Analysis|||||-20.49|-65.25|0.001
70999587|NCT04038385|141506222|SUPERIORITY||Median Difference (Net)|23.91||||0.031|TWO_SIDED|95.0|2.21|45.62|||Mixed Models Analysis|||||45.62|2.21|0.031
70999588|NCT04038385|141506223|SUPERIORITY||Median Difference (Net)|-0.06||||0.662|TWO_SIDED|95.0|-0.33|0.21|||Mixed Models Analysis|||||0.21|-0.33|0.662
70999589|NCT04038385|141506224|SUPERIORITY||Mean Difference (Net)|0.28||||0.047|TWO_SIDED|95.0|0.0|0.55|||Mixed Models Analysis|||||0.55|0.00|0.047
70999590|NCT04038385|141506225|SUPERIORITY||Odds Ratio (OR)|17.39|||<|0.01|TWO_SIDED|95.0|8.64|35.02|||Regression, Logistic|||||35.02|8.64|<0.01
70999591|NCT04038385|141506226|SUPERIORITY||Odds Ratio (OR)|3.9||||0.056|TWO_SIDED|95.0|1.0|16.1|||Mixed Models Analysis|||||16.1|1.0|0.056
70999592|NCT04038385|141506227|SUPERIORITY||Odds Ratio (OR)|4.0||||0.05|TWO_SIDED|95.0|1.0|16.3|||Mixed Models Analysis|||||16.3|1.0|0.050
70999593|NCT04038385|141506228|SUPERIORITY||Mean Difference (Net)|-1.7||||0.001|TWO_SIDED|95.0|-2.5|-1.0|||Mixed Models Analysis|||||-1.0|-2.5|0.001
71100462|NCT02732145|141709665|EQUIVALENCE|Question: Is there a difference in the score for the specificity of vulvar lesions in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.3621|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the specificity of vulvar lesions (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.3621
71100463|NCT02732145|141709665|EQUIVALENCE|Question: Is there a difference in the score for non-specific vulvar lesions in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8987|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for non-specific vulvar lesions (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8987
70999594|NCT04038385|141506229|SUPERIORITY||Median Difference (Net)|-0.7||||0.082|TWO_SIDED|95.0|-1.4|0.1|||Mixed Models Analysis|||||0.1|-1.4|0.082
70999595|NCT04038385|141506230|SUPERIORITY||Mean Difference (Net)|-1.5||||0.001|TWO_SIDED|95.0|-2.2|-0.8|||Mixed Models Analysis|||||-0.8|-2.2|0.001
70999596|NCT04038385|141506231|SUPERIORITY||Median Difference (Net)|-0.7||||0.039|TWO_SIDED|95.0|-1.4|0.0|||Mixed Models Analysis|||||-0.0|-1.4|0.039
70999597|NCT04038385|141506232|SUPERIORITY||Mean Difference (Net)|0.0||||0.962|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|||||0.3|-0.3|0.962
70999598|NCT04038385|141506233|SUPERIORITY||Mean Difference (Net)|-0.2||||0.277|TWO_SIDED|95.0|-0.4|0.1|||Mixed Models Analysis|||||0.1|-0.4|.277
70999599|NCT04038385|141506234|SUPERIORITY||Median Difference (Net)|-0.4||||0.155|TWO_SIDED|95.0|-1.0|0.2|||Mixed Models Analysis|||||0.2|-1.0|0.155
70999600|NCT04038385|141506235|SUPERIORITY||Mean Difference (Net)|0.1||||0.74|TWO_SIDED|95.0|-0.5|0.7|||Mixed Models Analysis|||||0.7|-0.5|0.740
70999601|NCT04038385|141506236|SUPERIORITY||Median Difference (Net)|-0.2||||0.122|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|||||0.1|-0.5|.122
70999602|NCT04038385|141506237|SUPERIORITY||Mean Difference (Net)|-0.2||||0.177|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|||||0.1|-0.5|.177
70999603|NCT04038385|141506238|SUPERIORITY||Median Difference (Net)|0.1||||0.514|TWO_SIDED|95.0|-0.3|0.5|||Mixed Models Analysis|||||0.5|-0.3|0.514
70999604|NCT04038385|141506239|SUPERIORITY||Median Difference (Net)|0.2||||0.335|TWO_SIDED|95.0|-0.2|0.6|||Mixed Models Analysis|||||0.6|-0.2|0.335
70999605|NCT04038385|141506240|SUPERIORITY||Mean Difference (Net)|0.1||||0.75|TWO_SIDED|95.0|-0.4|0.6|||Mixed Models Analysis|||||0.6|-0.4|0.750
70999606|NCT04038385|141506241|SUPERIORITY||Mean Difference (Net)|-0.2||||0.455|TWO_SIDED|95.0|-0.7|0.3|||Mixed Models Analysis|||||0.3|-0.7|0.455
70999607|NCT04038385|141506242|SUPERIORITY||Mean Difference (Net)|0.9||||0.053|TWO_SIDED|95.0|0.0|1.8|||Mixed Models Analysis|||||1.8|-0.0|0.053
70999608|NCT04038385|141506243|SUPERIORITY||Mean Difference (Net)|0.0||||0.986|TWO_SIDED|95.0|-0.9|0.9|||Mixed Models Analysis|||||0.9|-0.9|.986
70999609|NCT04038385|141506244|SUPERIORITY||Odds Ratio (OR)|1.1||||0.81|TWO_SIDED|95.0|0.6|2.2|||Mixed Models Analysis|||||2.2|0.6|0.810
70999610|NCT04038385|141506245|SUPERIORITY||Odds Ratio (OR)|0.8||||0.591|TWO_SIDED|95.0|0.4|1.7|||Mixed Models Analysis|||||1.7|0.4|0.591
70999611|NCT03961295|141506249|OTHER||Ratio of Geometric LSMs|1.2984|||||TWO_SIDED|90.0|1.0786|1.5486||||||Geometric least-squares means (LSMs) were calculated by exponentiating the LSMs derived from analysis of variance (ANCOVA) with weight as a covariate. Confidence intervals (CIs) were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.||1.5486|1.0786|
70999612|NCT03961295|141506250|OTHER||Ratio of Geometric LSMs|1.3274|||||TWO_SIDED|90.0|1.1147|1.5807||||||Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.||1.5807|1.1147|
70999613|NCT03961295|141506251|OTHER||Ratio of Geometric LSMs|1.1978|||||TWO_SIDED|90.0|1.0394|1.3804||||||Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.||1.3804|1.0394|
70999614|NCT01819506|141506311|SUPERIORITY|||||||0.912|||||||ANOVA|||||||0.912
70999615|NCT03000686|141506314|OTHER||Median Difference (Net)|0.021|STANDARD_DEVIATION|1.1339|||TWO_SIDED|95.0|-2.249|2.295|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 15 minutes post-infusion|||2.295|-2.249|
70999616|NCT03000686|141506314|OTHER||Median Difference (Net)|-4.021|STANDARD_DEVIATION|2.5923|||TWO_SIDED|95.0|-9.168|1.146|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 60 minutes post-chamber entry.|||1.146|-9.168|
70999617|NCT03000686|141506314|OTHER||Median Difference (Net)|-1.668|STANDARD_DEVIATION|4.4927|||TWO_SIDED|95.0|-10.576|7.231|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for immediately post-exercise|||7.231|-10.576|
70999618|NCT03000686|141506314|OTHER||Median Difference (Net)|-0.824|STANDARD_DEVIATION|1.6695|||TWO_SIDED|95.0|-4.142|2.506|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 30 minutes post-chamber exit|||2.506|-4.142|
70999619|NCT03000686|141506315|OTHER||Median Difference (Net)|-0.662|STANDARD_DEVIATION|2.1933|||TWO_SIDED|95.0|-5.037|3.815|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 15 minutes post-infusion|||3.815|-5.037|
70999620|NCT03000686|141506315|OTHER||Median Difference (Net)|-2.796|STANDARD_DEVIATION|3.4297|||TWO_SIDED|95.0|-9.729|4.027|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 60 minutes post-chamber entry.|||4.027|-9.729|
70999621|NCT03000686|141506315|OTHER||Median Difference (Net)|-0.018|STANDARD_DEVIATION|4.145|||TWO_SIDED|95.0|-8.475|8.086|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 2 minutes post-exercise start|||8.086|-8.475|
70999622|NCT03000686|141506315|OTHER||Median Difference (Net)|-0.291|STANDARD_DEVIATION|2.3277|||TWO_SIDED|95.0|-4.96|4.386|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 30 minutes post-chamber exit|||4.386|-4.960|
70999623|NCT03000686|141506322|OTHER||Median Difference (Net)|-0.148|STANDARD_DEVIATION|0.5622|||TWO_SIDED|95.0|-1.264|0.973|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 15 minutes post-infusion is presented.|||0.973|-1.264|
70999624|NCT03000686|141506322|OTHER||Median Difference (Net)|-1.172|STANDARD_DEVIATION|2.072|||TWO_SIDED|95.0|-5.271|2.942|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 60 minutes post-chamber entry is presented.|||2.942|-5.271|
70999625|NCT03000686|141506322|OTHER||Median Difference (Net)|-0.169|STANDARD_DEVIATION|2.2351|||TWO_SIDED|95.0|-4.624|4.258|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation immediately post-exercise is presented.|||4.258|-4.624|
70999626|NCT03000686|141506322|OTHER||Median Difference (Net)|-0.367|STANDARD_DEVIATION|0.5649|||TWO_SIDED|95.0|-1.498|0.753|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 30 minutes post-chamber exit is presented.|||0.753|-1.498|
70999627|NCT03000686|141506323|OTHER||Median Difference (Net)|0.203|STANDARD_DEVIATION|0.8872|||TWO_SIDED|95.0|-1.578|1.968|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 15 minutes post-infusion is presented.|||1.968|-1.578|
70999628|NCT03000686|141506323|OTHER||Median Difference (Net)|3.76|STANDARD_DEVIATION|1.8799|||TWO_SIDED|95.0|-0.001|7.495|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 60 minutes post-chamber entry is presented.|||7.495|-0.001|
70999629|NCT03000686|141506323|OTHER||Median Difference (Net)|-1.029|STANDARD_DEVIATION|2.8146|||TWO_SIDED|95.0|-6.673|4.578|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 2 minutes post-exercise start is presented.|||4.578|-6.673|
70999630|NCT03000686|141506323|OTHER||Median Difference (Net)|-0.873|STANDARD_DEVIATION|0.762|||TWO_SIDED|95.0|-2.38|0.669|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 30 minutes post-chamber exit is presented.|||0.669|-2.380|
70999631|NCT00294684|141506352|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.14||||0.43|TWO_SIDED|95.0|0.83|1.57|||Log binomial|||RR greater than one indicates benefit of steriods and a P value of treatment success from a log-binomial model with these covariates: Treatment group, age a HPE, BASM as fixed effects, and site as a random effect.||1.57|0.83|0.43
70999632|NCT00294684|141506353|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0||||0.99|TWO_SIDED|95.0|0.6|1.8|||Regression, Cox|||||1.8|0.6|0.99
70999633|NCT00294684|141506354|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.6||||0.0973|TWO_SIDED|95.0|-3.49|0.3|||Mixed Models Analysis|||LS Mean difference reported as steroid minus placebo (negative values mean larger average values of total bilirubin in placebo).||0.3|-3.49|0.0973
70923914|NCT03978871|141339884|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.458|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education) for the ERS emotion regulation involuntary dysregulation subscale post psycho-educational lesson. This is a test of between-subjects effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.458
70923915|NCT03978871|141339884|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.037|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education) for the ERS emotion regulation proactive engagement subscale post psycho-educational lesson. This is a test of between-subjects effect.||||0.037
70923916|NCT03978871|141339884|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.107|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education) for the ERS emotion regulation proactive engagement subscale post psycho-educational lesson. This is a test of between-subjects effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.107
70999634|NCT00294684|141506355|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.3||||0.0552|TWO_SIDED|95.0|-4.65|0.05|||Mixed Models Analysis|||LS Mean difference of steroid minus placebo (negative values indicate larger average values of bilirubin in placebo)||0.05|-4.65|0.0552
70999635|NCT00294684|141506356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.39||||0.6607||95.0|-2.16|1.38|||Mixed Models Analysis|||LS Mean difference of steroid minus placebo (negative values indicate larger average bilirubin in placebo)||1.38|-2.16|0.6607
70999636|NCT00294684|141506357|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1603|||||||Mixed Models Analysis|||||||0.1603
70999637|NCT00294684|141506358|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2801|||||||Mixed Models Analysis|||||||0.2801
70999638|NCT00294684|141506359|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.4||||0.41|TWO_SIDED|95.0|0.62|3.14|||Log Binomial|||||3.14|0.62|0.41
70999639|NCT00294684|141506360|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.3||||0.29|TWO_SIDED|95.0|0.03|2.92|||Log Binomial|||||2.92|0.03|0.29
70999640|NCT00968708|141506369|NON_INFERIORITY_OR_EQUIVALENCE|If after accrual of 550 participants with MACE events, the upper bound of a 1-sided repeated CI for the hazard ratio (alogliptin to placebo) was \<1.0, superiority of alogliptin to placebo for the primary MACE composite would be concluded. If the upper bound of the 1-sided repeated CI for the hazard ratio of the primary MACE composite was \<1.3 but ≥1.0 then non-inferiority but not superiority of alogliptin to placebo was to be concluded.|Hazard Ratio (HR)|0.962||||0.315|ONE_SIDED|97.5||1.16|||Cox proportional hazards|||Statistical analyses of the primary MACE composite endpoint was based on sequences of 1-sided repeated confidence intervals (CIs) to assess non-inferiority or statistical superiority with respect to the null hypotheses. Each sequence of repeated CIs was constructed using critical values from a 1-sided stopping boundary for a group sequential design (GSD), to preserve an overall false-rejection rate of 2.5%. Each sequence of 1-sided repeated CIs had a simultaneous coverage probability of 97.5%.||1.160||0.315
70999641|NCT00968708|141506369|NON_INFERIORITY_OR_EQUIVALENCE|If after accrual of 550 participants with MACE events, the upper bound of a 1-sided repeated CI for the hazard ratio (alogliptin to placebo) was \<1.0, superiority of alogliptin to placebo for the primary MACE composite would be concluded. If the upper bound of the 1-sided repeated CI for the hazard ratio of the primary MACE composite was \<1.3 but ≥1.0 then non-inferiority but not superiority of alogliptin to placebo was to be concluded.|Hazard Ratio (HR)|0.965||||0.332|ONE_SIDED|97.5||1.169||Stratified by endpoint renal function (defined as the last observed postbaseline renal function (normal renal function/mild renal impairment vs moderate/severe renal impairment including end-stage renal disease)) and geographic region.|Cox proportional hazards|||Stratified by endpoint renal function and geographic region||1.169||0.332
70999642|NCT00968708|141506370|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the confidence interval for the primary MACE composite was \<1.0, then statistical superiority of alogliptin to placebo for the secondary MACE composite would be demonstrated.|Hazard Ratio (HR)|0.952|||||ONE_SIDED|97.5||1.135||||||||1.135||
70999643|NCT00861380|141506429|SUPERIORITY|VE (defined as 1 minus Relative Risk (RR)) was calculated by comparing numbers of culture-confirmed IPD. The number of subjects with IPD in each cluster was compared between groups (10PN3+1 vs Control). This comparison was done using a negative binomial log-linear model with correction for dispersion group- and cluster- related effect.|VE (1-RR)|100.0|||<|0.0001|TWO_SIDED|95.0|82.8|100.0||P-value was calculated using a classical log linear Poisson regression with strata, without taking into account the multiplicity of the endpoints.|Regression, Linear|||Analysis aimed at providing an estimate of vaccine effectiveness (VE) at preventing culture-confirmed IPD by comparing PYARs between groups taking into account the following parameters: T, n, n+ (number of clusters with at least one event culture-confirmed ID), and n/T. VE of the 10Pn vaccine in preventing culture-confirmed IPD due to the 10 vaccine serotypes was demonstrated if the 2-sided p-value calculated for the null hypothesis H0 =(vaccine-type \[VT\] IPD VE = 0%) was lower than (\<) 5%.||100|82.8|<0.0001
70923917|NCT03978871|141339884|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.369|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education) for the ERS emotion regulation cognitive avoidance subscale post psycho-educational lesson. This is a test of between-subjects test.||||0.369
70923918|NCT03978871|141339885|SUPERIORITY|Data were collected using a Siemens Prisma MRI 3T scanner and preprocessed with fMRIprep. An ROI mask was generated from left and right amygdala of the AAL1.V4 atlas. First-level contrast estimates (negative immerse \> neutral immerse) for each voxel within the ROI were averaged with MarsBaR to produce a single value for each person. A two-sample t-test was conducted in R to test for differences across intervention groups (mindset vs control).||||||0.265||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(146) = -1.12||||||0.265
70923919|NCT03978871|141339886|SUPERIORITY|Data were collected using a Siemens Prisma MRI 3T scanner and preprocessed with fMRIprep. An ROI mask was generated from left and right amygdala of the AAL1.V4 atlas. First-level contrast estimates (negative \> neutral) for each voxel within the ROI were averaged with MarsBaR to produce a single value for each person. A two-sample t-test was conducted in R to test for differences across intervention groups (mindset vs control).||||||0.96||||||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|t(145) = -0.53||||||0.96
70923920|NCT03978871|141339887|SUPERIORITY|Data were preprocessed in fMRIprep. Separate right/left amygdala seeds were defined with the AAL1 atlas. Interaction regressors were created between seeds and task conditions. Average contrast estimates for interaction terms of relevant trials (negative reframe \> negative immerse) were extracted with MarsBaR from 15 ROIs in the FPN of a modified Schaefer atlas and the 30 values averaged. A two-sample t-test was conducted in R to compare average connectivity between groups (mindset vs control).||||||0.76||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(146) = -.3047||||||0.76
70999644|NCT00861380|141506430|SUPERIORITY|VE (defined as 1 minus Relative Risk (RR)) was calculated by comparing numbers of culture-confirmed IPD. The number of subjects with IPD in each cluster was compared between groups (10PN2+1vsControl). This comparison was done using a negative binomial log-linear model with correction for dispersion group- and cluster- related effect.|VE (1-RR)|91.8|||=|0.0009|TWO_SIDED|95.0|58.3|99.6||p-value was calculated using a classical log linear Poisson regression with strata, without taking into account the multiplicity of the endpoints.|Regression, Linear|||Analysis aimed at providing an estimate of vaccine effectiveness (VE) at preventing culture-confirmed IPD by comparing PYARs between groups taking into account the following parameters: T, n, n+ (number of clusters with at least one event culture-confirmed ID), and n/T. VE of the 10Pn vaccine in preventing culture-confirmed IPD due to the 10 vaccine serotypes was demonstrated if the 2-sided p-value calculated for the null hypothesis H0 = (vaccine-type \[VT\] IPD VE = 0%) was lower than (\<) 5%.||99.6|58.3|= 0.0009
70999645|NCT00861380|141506434|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 2626735.|PYAR|14.657|||||TWO_SIDED|95.0|13.229|16.197|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||16.197|13.229|
70999646|NCT00861380|141506434|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 1354702.|PYAR|13.582|||||TWO_SIDED|95.0|11.691|15.693|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||15.693|11.691|
71041826|NCT02618382|141592800|SUPERIORITY||||||<|0.05||||||The P values for differences among time point means were determined by ANOVA for continuous variables|ANOVA|||Nonparametric tests were used for statistical comparison, including the Kruskal-Wallis rank-sum test for multiple groups and the Mann-Whitney U test for 2 groups. P values \<0.05 were considered statistically significant. Data tabulation and analysis were performed using R statistical software version 3.4.2 (R Foundation for Statistical Computing, Vienna, Austria).||||<0.05
71041827|NCT02618382|141592801|SUPERIORITY||||||<|0.05||||||Paired comparison of hematoma thickness at defined time point means determined by ANOVA for continuous variables.|ANOVA|||Nonparametric tests were used for statistical comparison, including the Kruskal-Wallis rank-sum test for multiple groups and the Mann-Whitney U test for 2 groups. P values \<0.05 were considered statistically significant. Data tabulation and analysis were performed using R statistical software version 3.4.2 (R Foundation for Statistical Computing, Vienna, Austria).||||<0.05
71041828|NCT02618382|141592802|OTHER||||||<|0.05||||||The P values for differences among time point means were determined by ANOVA for continuous variables and by chi-squared test for categorical values in grouped mRS scores.|ANOVA|||Nonparametric tests were used for statistical comparison, including the Kruskal-Wallis rank-sum test for multiple groups and the Mann-Whitney U test for 2 groups. P values \<0.05 were considered statistically significant. Data tabulation and analysis were performed using R statistical software version 3.4.2 (R Foundation for Statistical Computing, Vienna, Austria).||||<0.05
71041829|NCT03173560|141592817|NON_INFERIORITY|Odd ratio for ORR24W was analyzed along with 90% CI for each treatment arm using Cochran-Mantel-Haenszel (CMH) method, stratified by Memorial Sloan-Kettering Cancer Center (MSKCC) prognostic group and prior programmed cell death protein 1/ programmed cell death protein ligand 1 (PD-1/PD-L1) treatment from IxRS data. Non-inferiority would be claimed if 1-sided P value is \<=0.045 at the final analysis for the non-inferiority test with the non-inferiority margin of the odd ratio =0.76.|Odds Ratio (OR)|0.88||||0.2676|TWO_SIDED|90.0|0.59|1.32|||Cochran-Mantel-Haenszel|||||1.32|0.59|0.2676
71041830|NCT03173560|141592818|SUPERIORITY|Percentage of participants with intolerable Grade 2 or any Grade \>=Grade 3 TEAEs within 24 weeks was tested using CMH method at 2-sided α=0.05, stratified by MSKCC prognostic group and prior PD-1/PD-L1 treatment from IxRS data. The treatment difference and 95% CI were also calculated based on asymptotic normal approximation.|Difference|3.2||||0.4763|TWO_SIDED|95.0|-5.5|11.9|||Cochran-Mantel-Haenszel|||||11.9|-5.5|0.4763
71041831|NCT03173560|141592819|OTHER|The hazard ratio and the corresponding 90% CIs were estimated using the Cox regression model with Efron's method for ties, stratified by MSKCC prognostic group and prior PD-1/PD-L1 treatment.|Hazard Ratio (HR)|1.42|||||TWO_SIDED|90.0|1.08|1.86||||||||1.86|1.08|
71041832|NCT03173560|141592820|OTHER|Odd ratio for ORR was analyzed along with 90% CI for each treatment arm using CMH method stratified by MSKCC prognostic group and PD-1/PD-L1 treatment from IxRS data.|Odds Ratio (OR)|0.77|||||TWO_SIDED|90.0|0.52|1.14||||||||1.14|0.52|
70923921|NCT03978871|141339888|SUPERIORITY|Data were preprocessed in fMRIprep. Separate right/left amygdala seeds were defined with the AAL1 atlas. Interaction regressors were created between seeds and task conditions. Average contrast estimates for interaction terms of relevant trials (negative \> neutral) were extracted with MarsBaR from 15 ROIs in the FPN of a modified Schaefer atlas and the 30 values averaged. A two-sample t-test was conducted in R to compare average connectivity between groups (mindset vs control).||||||0.048||||||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|t(145) = 1.998, p = .048||||||.048
71100464|NCT02732145|141709665|EQUIVALENCE|Question: Is there a difference in the score for specific vulvar lesions in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology (first biopsy)?||||||0.0018|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for vulvar lesions specific for dermatosis (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology (first biopsy).||||0.0018
71100465|NCT02732145|141709665|EQUIVALENCE|"Question: Is there a difference in the overall sum of points for the Vulvoscopy Index in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.4409|||||||Wilcoxon (Mann-Whitney)|||"Parameter: The difference in the overall sum of points for the Vulvoscopy Index (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.4409
71100466|NCT02732145|141709666|OTHER|"Question: Determination of sensitivity of the N-S-P Scheme as a measure of the sensitivity of Three Rings Vulvoscopy, in comparison to the histopathological diagnosis of vulvar dermatosis."|Sensitivity (2x2 Table)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||"The Sensitivity of the N-S-P Scheme for Detection of Vulvar Dermatosis was 1.0000 (Range: 1.0000 - 1.0000)."|"Parameter: Sensitivity of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|1.0000|
71100467|NCT02732145|141709666|OTHER|"Question: Determination of specificity of the N-S-P Scheme as a measure of the specificity of Three Rings Vulvoscopy, in comparison to the histopathological diagnosis of vulvar dermatosis."|Specificity (2x2 Table)|0.9609|||||TWO_SIDED|95.0|0.5794|1.0|||||"The Specificity of the N-S-P Scheme for Detection of Vulvar Dermatosis was 0.9609 (Range: 0.5794 - 1.0000)."|"Parameter: Specificity of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|0.5794|
71100468|NCT02732145|141709666|OTHER|"Question: Determination of diagnostic accuracy of the N-S-P Scheme as a measure of the diagnostic value of the Three Rings Vulvoscopy, in relation to the histopathological diagnosis of vulvar dermatosis."|Diagnostic Accuracy (2x2 Table)|0.9695|||||TWO_SIDED|95.0|0.6313|1.0|||||"The Diagnostic accuracy of the N-S-P Scheme for Detection of Vulvar Dermatosis was 0.9695 (Range: 0.6313 - 1.0000)."|"Parameter: Diagnostic accuracy of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|0.6313|
71100469|NCT02732145|141709666|OTHER|"Question: Determination of positive predictive value of the N-S-P Scheme for detection of vulvar dermatosis in comparison to the histopathology results."|PPV (2x2 Table)|0.878|||||TWO_SIDED|95.0|0.227|1.0|||||"Positive predictive value of the N-S-P Scheme for Detection of Vulvar Dermatosis was 0.8780 (Range: 0.2270 - 1.0000)."|"Parameter: Positive predictive value of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|0.2270|
70999647|NCT00861380|141506434|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 2626735.|PYAR|8.452|||||TWO_SIDED|95.0|7.376|9.639|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||9.639|7.376|
71100470|NCT02732145|141709666|OTHER|"Question: Determination of negative predictive value of the N-S-P Scheme for detection of vulvar dermatosis in comparison to the histopathology results."|NPV (2x2 Table)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||"Negative predictive value of the N-S-P Scheme for Detection of Vulvar Dermatosis was 1.0000 (Range: 1.0000 - 1.0000)."|"Parameter: Negative predictive value of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|1.0000|
71100471|NCT02732145|141709666|SUPERIORITY|"Question: Is there a difference in the diagnostic accuracy of the N-S-P Scheme as an outcome measure of the diagnostic value of Three Rings Vulvoscopy, and histopathology?"||||||0.6108|||||||t-test proportion|||"Parameter: The difference in the diagnostic accuracy between TRIV using the N-S-P Scheme and histopathology for detection of vulvar dermatosis."||||0.6108
71100472|NCT02732145|141709667|SUPERIORITY|"Question: Is there a difference in the frequency of N-#-# result (no lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.9286|||||||t-test proportion|||"Parameter: The difference in the frequency of N-#-# result (no lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.9286
71100473|NCT02732145|141709667|SUPERIORITY|"Question: Is there a difference in the frequency of S-#-# result (non-specific lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8618|||||||t-test proportion|||"Parameter: The difference in the frequency of S-#-# result (non-specific lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8618
71100474|NCT02732145|141709667|SUPERIORITY|"Question: Is there a difference in the frequency of P-#-# result (specific lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.9786|||||||t-test proportion|||"Parameter: The difference in the frequency of P-#-# result (specific lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.9786
70999648|NCT00861380|141506434|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 1354702.|PYAR|7.603|||||TWO_SIDED|95.0|6.206|9.221|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||9.221|6.206|
70999649|NCT00861380|141506434|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 2626735.|PYAR|1.637|||||TWO_SIDED|95.0|1.185|2.205|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||2.205|1.185|
70999650|NCT00861380|141506434|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 1354702.|PYAR|1.845|||||TWO_SIDED|95.0|1.194|2.724|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||2.724|1.194|
70999651|NCT00861380|141506434|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as . 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons = 2626735.|PYAR|3.997|||||TWO_SIDED|95.0|3.269|4.839|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine \& non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||4.839|3.269|
71041833|NCT04254809|141592835|SUPERIORITY||Slope|-0.64|STANDARD_ERROR_OF_MEAN|0.19||0.001|TWO_SIDED|95.0|-1.02|-0.25||Threshold for statistical significance was p = .05|Regression, Linear||REST coded as 0, HSL coded as 1; negative slope reflects greater standardized reductions in outcome among REST compared to HSL|Intention to treat analyses carried last observation forward for all participants enrolled at baseline. Standardized residual change score calculated by regressing scores at one-week follow-up onto scores at baseline.||-0.25|-1.02|.001
71041834|NCT04254809|141592836|SUPERIORITY||Slope|-0.61|STANDARD_ERROR_OF_MEAN|0.19||0.002|TWO_SIDED|95.0|-0.99|-0.23||Threshold for significance was p = .05|Regression, Linear||REST coded as 0, HSL coded as 1; negative slope reflects greater standardized reductions in outcome among REST compared to HSL|Intention to treat analyses carried last observation forward for all participants enrolled at baseline. Standardized residual change score calculated by regression scores at one-month follow-up onto scores at baseline.||-0.23|-0.99|.002
71100475|NCT02732145|141709667|SUPERIORITY|"Question: Is there a difference in the frequency of #-N-# result (no lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||1|||||||t-test proportion|||"Parameter: The difference in the frequency of #-N-# result (no lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||1.0000
71041835|NCT04254809|141592837|SUPERIORITY||Slope|-0.45|STANDARD_ERROR_OF_MEAN|0.2||0.03|TWO_SIDED|95.0|-0.86|-0.05||Threshold for statistical significance was p = .05|Regression, Linear||REST coded as -, HSL coded as 1; negative slope reflects greater standardized reductions in outcome among REST compared to HSL.|Intention to treat analyses carried last observation forward for all participants enrolled at baseline. Standardized residual change score calculated by regression scores at one-week follow-up onto scores at baseline.||-.05|-0.86|.03
71041836|NCT02795676|141592857|NON_INFERIORITY|Non-inferiority was to be declared if the lower bound of the confidence interval for the treatment difference is above the non-inferiority margin, which was met. No p-value was calculated as this is not relevant for non-inferiority.|Median Difference (Final Values)|-0.359|||||TWO_SIDED|95.0|-2.444|1.726|||Regression, Linear|The primary efficacy analysis compared eGFR slope between the treatment arms using a 2-stage model with quantile regression.||||1.726|-2.444|
71041837|NCT02690935|141592889|SUPERIORITY|||||||0.642||||||No adjustment of the p-value|t-test, 2 sided|||H0: The efficacy of 2LALERG and placebo are similar H1: The efficacy of 2LALERG and placebo are different||||0.642
70923922|NCT03978871|141339889|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.833|||||||ANOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation). This is a test of between by within-subjects interaction effect.||||0.833
70999652|NCT00861380|141506434|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons = 1354702.|PYAR|3.322|||||TWO_SIDED|95.0|2.423|4.445|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine \& non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||4.445|2.423|
70999653|NCT00861380|141506434|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2636783.|PYAR|14.487|||||TWO_SIDED|95.0|13.071|16.015|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||16.015|13.071|
70999654|NCT00861380|141506434|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1360966.|PYAR|13.74|||||TWO_SIDED|95.0|11.841|15.857|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||15.857|11.841|
70999655|NCT00861380|141506434|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2636783.|PYAR|7.813|||||TWO_SIDED|95.0|6.782|8.955|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||8.955|6.782|
70999656|NCT00861380|141506434|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1360966.|PYAR|7.789|||||TWO_SIDED|95.0|6.377|9.42|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||9.420|6.377|
70999657|NCT00861380|141506434|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2636783.|PYAR|2.313|||||TWO_SIDED|95.0|1.77|2.972|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||2.972|1.770|
71008585|NCT02055976|141525229|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-41.372|STANDARD_ERROR_OF_MEAN|2.983|<|0.001|TWO_SIDED|95.0|-47.299|-35.445|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-35.445|-47.299|<0.001
70923923|NCT03978871|141339890|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.321|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education) across self-reported affect on the SET task. This is a test of between-subjects effect.||||0.321
70923924|NCT03978871|141339891|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.002|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) for fixed emotion mindset scores from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.002
70923925|NCT03978871|141339891|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.005|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on fixed emotion mindset scores from time 1 to time 2. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons included as a covariate.||||0.005
70923926|NCT03978871|141339892|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.033|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on fixed emotion mindset scores from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||.033
70923927|NCT03978871|141339893|SUPERIORITY|Threshold for statistical significance was p = 0.05||||||0.403|||||||ANOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy scores from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.403
70923928|NCT03978871|141339893|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.19|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy scores from time 1 to time 2. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.190
70999658|NCT00861380|141506434|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1360966.|PYAR|1.984|||||TWO_SIDED|95.0|1.307|2.886|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||2.886|1.307|
70999659|NCT00861380|141506434|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model without strata). Total number of non-vaccinated persons =2636783.|PYAR|4.172|||||TWO_SIDED|95.0|3.429|5.028|||Negative Binomial model without strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine \& non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||5.028|3.429|
71041838|NCT02690935|141592890|SUPERIORITY|||||||0.829||||||No adjustment for multiplicity|t-test, 2 sided|||H0: 2LALERG and placebo have the same effect on the quality of life H1: 2LALERG and placebo do not have the same effect on the quality of life||||0.829
70923929|NCT03978871|141339894|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.784||||||degrees of freedom = 1.|ANOVA|||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy scores from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.784
71041839|NCT03566238|141592912|SUPERIORITY|"ANCOVA model including treatment, baseline pruritus score at AM and PM, PFIC type, and age category was used for treatment comparisons. A pooled analysis for the closed testing procedure was applied to control multiplicity. The one-sided adjusted p-value for an individual dose was calculated as the maximum value of the unadjusted p-value for the pooled analysis and the unadjusted p-value for the individual doses.~One-sided adjusted p-value was reported."|LS mean difference|28.23|STANDARD_ERROR_OF_MEAN|9.182||0.0019|TWO_SIDED|95.0|9.83|46.64|||ANCOVA|||Analysis of the Proportion of Positive Pruritus Assessments at Participant Level over the 24-Week Treatment Period - Albireo ObsRO Instrument (AM and PM Scores)||46.64|9.83|0.0019
70923930|NCT03978871|141339894|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.586|||||||ANCOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy scores from time 1 to time 3. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.586
70923931|NCT03978871|141339895|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.916|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy vignette scores from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.916
70923932|NCT03978871|141339895|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.343|||||||ANCOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy vignette scores from time 1 to time 2. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.343
70923933|NCT03978871|141339896|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.048|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy vignette scores from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.048
70923934|NCT03978871|141339896|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.153|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy vignette scores from time 1 to time 3. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lesson was included as a covariate.||||0.153
70999660|NCT00861380|141506434|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model without strata). Total number of non-vaccinated persons =1360966.|PYAR|3.968|||||TWO_SIDED|95.0|2.981|5.177|||Negative Binomial model without strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine \& non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||5.177|2.981|
70999661|NCT00861380|141506434|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2654010.|PYAR|14.017|||||TWO_SIDED|95.0|12.628|15.516|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||15.516|12.628|
70999662|NCT00861380|141506434|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1367343.|PYAR|15.066|||||TWO_SIDED|95.0|13.079|17.269|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||17.269|13.079|
71008586|NCT02055976|141525229|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-25.374|STANDARD_ERROR_OF_MEAN|2.69|<|0.001|TWO_SIDED|95.0|-30.717|-20.032|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-20.032|-30.717|<0.001
71008587|NCT02055976|141525229|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-33.49|STANDARD_ERROR_OF_MEAN|2.741|<|0.001|TWO_SIDED|95.0|-38.934|-28.047|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-28.047|-38.934|<0.001
71008588|NCT02055976|141525229|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-38.76|STANDARD_ERROR_OF_MEAN|2.77|<|0.001|TWO_SIDED|95.0|-44.262|-33.258|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-33.258|-44.262|<0.001
71100476|NCT02732145|141709667|SUPERIORITY|"Question: Is there a difference in the frequency of #-S-# result (non-specific lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8634|||||||t-test proportion|||"Parameter: The difference in the frequency of #-S-# result (non-specific lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8634
71100477|NCT02732145|141709667|SUPERIORITY|"Question: Is there a difference in the frequency of #-P-# result (specific lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.7992|||||||t-test proportion|||"Parameter: The difference in the frequency of #-P-# result (specific lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.7992
71008589|NCT02055976|141525229|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-30.847|STANDARD_ERROR_OF_MEAN|2.879|<|0.001|TWO_SIDED|95.0|-36.568|-25.127|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-25.127|-36.568|<0.001
71008590|NCT02055976|141525229|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.019|STANDARD_ERROR_OF_MEAN|2.887|<|0.001|TWO_SIDED|95.0|-45.754|-34.285|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-34.285|-45.754|<0.001
70923935|NCT03978871|141339897|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.566|||||||ANOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD proactive engagement scores from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.566
70999663|NCT00861380|141506434|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2654010.|PYAR|5.916|||||TWO_SIDED|95.0|5.026|6.917|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||6.917|5.026|
70999664|NCT00861380|141506434|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1367343.|PYAR|8.557|||||TWO_SIDED|95.0|7.077|10.255|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||10.255|7.077|
70999665|NCT00861380|141506434|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons =2654010.|PYAR|2.977|||||TWO_SIDED|95.0|2.357|3.71|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||3.710|2.357|
70999666|NCT00861380|141506434|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons =1367343.|PYAR|2.048|||||TWO_SIDED|95.0|1.361|2.96|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||2.960|1.361|
70999667|NCT00861380|141506434|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2654010.|PYAR|5.011|||||TWO_SIDED|95.0|4.196|5.939|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine \& non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||5.939|4.196|
70999668|NCT00861380|141506434|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1367343.|PYAR|4.315|||||TWO_SIDED|95.0|3.285|5.566|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine \& non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||5.566|3.285|
71008591|NCT02055976|141525229|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-43.947|STANDARD_ERROR_OF_MEAN|2.869|<|0.001|TWO_SIDED|95.0|-49.647|-38.247|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-38.247|-49.647|<0.001
71100478|NCT02732145|141709667|SUPERIORITY|"Question: Is there a difference in the frequency of #-#-N result (no lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.3912|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-N result (no lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.3912
71041840|NCT03566238|141592912|SUPERIORITY|"ANCOVA model including treatment, baseline pruritus score at AM and PM, PFIC type, and age category was used for treatment comparisons. A pooled analysis for the closed testing procedure was applied to control multiplicity. The one-sided adjusted p-value for an individual dose was calculated as the maximum value of the unadjusted p-value for the pooled analysis and the unadjusted p-value for the individual doses.~One-sided adjusted p-value was reported."|LS mean difference|21.71|STANDARD_ERROR_OF_MEAN|9.892||0.0163|TWO_SIDED|95.0|1.87|41.54|||ANCOVA|||Analysis of the Proportion of Positive Pruritus Assessments at Participant Level over the 24-Week Treatment Period - Albireo ObsRO Instrument (AM and PM Scores)||41.54|1.87|0.0163
71041841|NCT03566238|141592913|SUPERIORITY||proportion difference|0.435||||0.0015|TWO_SIDED|95.0|0.2195|0.6551|||Cochran-Mantel-Haenszel|||"Analysis was based on the Cochran Mantel Haenszel test adjusting PFIC type. A pooled analysis for the closed testing procedure was applied to control multiplicity. The one-sided adjusted p-value for an individual dose was calculated as the maximum value of the unadjusted p-value for the pooled analysis and the unadjusted p-value for the individual doses.~One-sided adjusted p-value was reported."||0.6551|0.2195|0.0015
71041842|NCT03566238|141592913|SUPERIORITY||proportion difference|0.211||||0.0174|TWO_SIDED|95.0|0.021|0.4557|||Cochran-Mantel-Haenszel|||Analysis was based on the Cochran Mantel Haenszel test adjusting PFIC type. A pooled analysis for the closed testing procedure was applied to control multiplicity. The one-sided adjusted p-value for an individual dose was calculated as the maximum value of the unadjusted p-value for the pooled analysis and the unadjusted p-value for the individual doses. One-sided adjusted p-value was reported.||0.4557|0.021|0.0174
71041843|NCT00373425|141592922|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.3235|TWO_SIDED|95.0|0.741|1.104||If the primary analysis of DFS was not statistically significant, the hierarchical testing procedure would stop and all key secondary efficacy analyses would be nonsignificant; any further analysis of these outcomes would be considered exploratory.|Log Rank||Hazard ratio: erlotinib to placebo|The null hypothesis that DFS distributions of the 2 arms were equivalent was tested using an unstratified 2-sided log-rank test at the 0.05 level. The primary analysis of DFS was performed when at least 410 events had accrued. If the result of the primary analysis of DFS was statistically significant favoring the erlotinib treatment arm, the null hypothesis of no treatment difference of key secondary efficacy variables was tested under a hierarchical testing procedure.||1.104|0.741|0.3235
71041844|NCT00373425|141592927|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.562|TWO_SIDED|95.0|0.78|1.144|||Log Rank|||The null hypothesis that DFS distributions of the 2 arms were equivalent was tested using an unstratified 2-sided log-rank test at the 0.05 level.||1.144|0.780|0.5620
71100479|NCT02732145|141709667|SUPERIORITY|"Question: Is there a difference in the frequency of #-#-S result (non-specific lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.6152|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-S result (non-specific lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.6152
71100480|NCT02732145|141709667|SUPERIORITY|"Question: Is there a difference in the frequency of #-#-P result (specific lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.6108|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-P result (specific lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.6108
71100481|NCT02732145|141709667|SUPERIORITY|"Question: Is there a difference in the frequency of N-N-N result (no lesions) in any of the Three Vulvar Rings in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||1|||||||t-test proportion|||"Parameter: The difference in the frequency of N-N-N result (no lesions) in any of the Three Vulvar Rings in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||1.0000
71100482|NCT02732145|141709667|SUPERIORITY|"Question: Is there a difference in the frequency of S result (non-specific lesions) in any of the Three Vulvar Rings (S-#-#; S-S-#; S-S-S; S-N-S etc.) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.7912|||||||t-test proportion|||"Parameter: The difference in the frequency of S result (non-specific lesions) in any of the Three Vulvar Rings (S-#-#; S-S-#; S-S-S; S-N-S etc.) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.7912
71100483|NCT02732145|141709667|SUPERIORITY|"Question: Is there a difference in the frequency of P result (specific lesions) in any of the Three Vulvar Rings (P-#-#; P-P-; P-P-P; P-N-S etc.) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||1|||||||t-test proportion|||"Parameter: The difference in the frequency of P result (specific lesions) in any of the Three Vulvar Rings (P-#-#; P-P-; P-P-P; P-N-S etc.) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||1.0000
71100484|NCT02732145|141709668|SUPERIORITY|"Question: Is there a difference in the frequency of N-#-# result (no lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.253|||||||t-test proportion|||"Parameter: The difference in the frequency of N-#-# result (no lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.2530
71041845|NCT04511208|141592948|SUPERIORITY||Difference in means|-2.2|||<|0.001|TWO_SIDED|95.0|-2.7|-1.7|||Repeated measures linear model|||||-1.7|-2.7|<0.001
71041846|NCT04511208|141592949|SUPERIORITY||Difference in means|-0.26||||0.006|TWO_SIDED|95.0|-0.44|-0.08|||Repeated measures linear model|||||-0.08|-0.44|0.006
71041847|NCT04511208|141592950|SUPERIORITY||Difference in means|-0.23||||0.046|TWO_SIDED|95.0|-0.45|-0.005|||Repeated measures linear model|||||-0.005|-0.45|0.046
71041848|NCT04511208|141592951|SUPERIORITY||Difference in means|-0.07||||0.955|TWO_SIDED|95.0|-2.51|2.38|||Repeated measures linear model|||C3B PST Score||2.38|-2.51|0.955
71041849|NCT04511208|141592951|SUPERIORITY||Difference in means|0.62||||0.686|TWO_SIDED|95.0|-2.48|3.71|||Repeated measures linear model|||C3B VMT Score||3.71|-2.48|0.686
71041850|NCT04511208|141592952|SUPERIORITY||Odds Ratio (OR)|2.5||||0.007|TWO_SIDED|95.0|1.28|4.68|||Generalized linear mixed effects model|||||4.68|1.28|0.007
71041851|NCT04511208|141592952|SUPERIORITY||Difference in means|-1.1||||0.009|TWO_SIDED|95.0|-1.82|-0.28|||Repeated measures linear model|||Sensitivity analysis||-0.28|-1.82|0.009
71041852|NCT04511208|141592953|SUPERIORITY||Difference in means|-1.06||||0.004|TWO_SIDED|95.0|-1.75|-0.38|||Repeated measures linear model|||||-0.38|-1.75|0.004
71100485|NCT02732145|141709668|SUPERIORITY|"Question: Is there a difference in the frequency of S-#-# result (non-specific lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8338|||||||t-test proportion|||"Parameter: The difference in the frequency of S-#-# result (non-specific lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8338
70999669|NCT00861380|141506442|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2626735.|PYAR|9.218|||||TWO_SIDED|95.0|9.103|9.335|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||9.335|9.103|
70999670|NCT00861380|141506442|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1354702.|PYAR|9.212|||||TWO_SIDED|95.0|9.052|9.375|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||9.375|9.052|
70999671|NCT00861380|141506442|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2636783.|PYAR|10.5|||||TWO_SIDED|95.0|10.378|10.624|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||10.624|10.378|
70999672|NCT00861380|141506442|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1360966.|PYAR|10.429|||||TWO_SIDED|95.0|10.259|10.601|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||10.601|10.259|
70999673|NCT00861380|141506442|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2654010.|PYAR|10.118|||||TWO_SIDED|95.0|9.997|10.239|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||10.239|9.997|
71041853|NCT04511208|141592954|SUPERIORITY||Difference in means|-2.97|||<|0.001|TWO_SIDED|95.0|-3.8|-2.13|||Repeated measures linear model|||||-2.13|-3.80|<0.001
71041854|NCT01835548|141592956|SUPERIORITY||Least Square Mean Difference|-11.04|STANDARD_ERROR_OF_MEAN|1.4239|<|0.0001|TWO_SIDED|95.0|-13.9|-8.2|||ANCOVA|||||-8.20|-13.9|<0.0001
71041855|NCT01488448|141592965|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.73
71041856|NCT01488448|141592966|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Fisher Exact|||||||0.77
71041857|NCT01488448|141592967|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Fisher Exact|||||||0.97
71041858|NCT01488448|141592968|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Fisher Exact|||||||0.67
71041859|NCT01488448|141592969|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.39
71041860|NCT01488448|141592970|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.18
71041861|NCT01488448|141592973|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.96
71041862|NCT00243152|141592995|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Visual analog scale (VAS) ratings in the scanner. Measures of pain ratings to evoked stimuli during scanning for heat applied to the affected side.||||<0.05
70999674|NCT00861380|141506442|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1367343.|PYAR|9.921|||||TWO_SIDED|95.0|9.755|10.088|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||10.088|9.755|
70999675|NCT00861380|141506450|OTHER|In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =229978.|PYAR|22.624|||||TWO_SIDED|95.0|22.02|23.24|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||23.240|22.020|
70999676|NCT00861380|141506450|OTHER|In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =120190.|PYAR|22.747|||||TWO_SIDED|95.0|21.912|23.606|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||23.606|21.912|
70999677|NCT00861380|141506450|OTHER|In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =214181.|PYAR|24.503|||||TWO_SIDED|95.0|23.852|25.166|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||25.166|23.852|
70999678|NCT00861380|141506450|OTHER|In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =112060.|PYAR|26.236|||||TWO_SIDED|95.0|25.308|27.189|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||27.189|25.308|
70999679|NCT00861380|141506450|OTHER|In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =211914.|PYAR|27.502|||||TWO_SIDED|95.0|26.81|28.207|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||28.207|26.810|
70999680|NCT00861380|141506450|OTHER|In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111071.|PYAR|26.1||||||95.0|25.171|27.055|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||27.055|25.171|
70999681|NCT00861380|141506450|OTHER|In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =213913.|PYAR|28.661|||||TWO_SIDED|95.0|27.958|29.377|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||29.377|27.958|
70999682|NCT00861380|141506450|OTHER|In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111414.|PYAR|29.835|||||TWO_SIDED|95.0|28.843|30.85|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||30.850|28.843|
70999683|NCT00861380|141506454|OTHER|In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =229978.|PYAR|816.813|||||TWO_SIDED|95.0|815.226|818.392|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||818.392|815.226|
71008592|NCT02055976|141525231|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-41.118|STANDARD_ERROR_OF_MEAN|3.344|<|0.001|TWO_SIDED|95.0|-47.76|-34.476|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-34.476|-47.760|<0.001
71008593|NCT02055976|141525231|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-54.787|STANDARD_ERROR_OF_MEAN|3.402|<|0.001|TWO_SIDED|95.0|-61.543|-48.032|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-48.032|-61.543|<0.001
71008594|NCT02055976|141525231|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-60.549|STANDARD_ERROR_OF_MEAN|3.453|<|0.001|TWO_SIDED|95.0|-67.403|-53.694|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-53.694|-67.403|<0.001
71008595|NCT02055976|141525231|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-36.589|STANDARD_ERROR_OF_MEAN|3.73|<|0.001|TWO_SIDED|95.0|-43.999|-29.178|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-29.178|-43.999|<0.001
71008596|NCT02055976|141525231|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-54.683|STANDARD_ERROR_OF_MEAN|3.734|<|0.001|TWO_SIDED|95.0|-62.102|-47.265|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-47.265|-62.102|<0.001
71008597|NCT02055976|141525231|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.517|STANDARD_ERROR_OF_MEAN|3.688|<|0.001|TWO_SIDED|95.0|-63.845|-49.189|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-49.189|-63.845|<0.001
71008598|NCT02055976|141525231|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-33.262|STANDARD_ERROR_OF_MEAN|3.196|<|0.001|TWO_SIDED|95.0|-39.608|-26.915|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-26.915|-39.608|<0.001
71008599|NCT02055976|141525231|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-45.956|STANDARD_ERROR_OF_MEAN|3.239|<|0.001|TWO_SIDED|95.0|-52.388|-39.523|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-39.523|-52.388|<0.001
70999684|NCT00861380|141506454|OTHER|In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =120190.|PYAR|841.176|||||TWO_SIDED|95.0|839.098|843.239|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||843.239|839.098|
71041863|NCT00243152|141592995|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for heat applied to the unaffected side.||||>0.05
71041864|NCT00243152|141592995|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for cold applied to the affected side.||||>0.05
71041865|NCT00243152|141592995|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for cold applied to the unaffected side.||||>0.05
71041866|NCT00243152|141592995|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for brush applied to the affected side.||||>0.05
71041867|NCT00243152|141592995|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for brush applied to the unaffected side.||||>0.05
71041868|NCT00401245|141593015|SUPERIORITY_OR_OTHER|||||||0.024||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|Chi-squared|||Overall comparison was made between each titration regimen and the control regimen (100 mg).||||0.024
71041869|NCT00401245|141593016|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50 mg QOD, analysis of variance (ANOVA) was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.||||< 0.001
71041870|NCT00401245|141593016|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50/25 mg, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.||||<0.001
71041871|NCT00401245|141593016|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50 mg/Placebo, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.||||<0.001
71041872|NCT00401245|141593017|SUPERIORITY_OR_OTHER|||||||0.092||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50 mg QOD, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor||||0.092
71041873|NCT00401245|141593017|SUPERIORITY_OR_OTHER|||||||0.997||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50/25 mg, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor||||0.997
71041874|NCT00401245|141593017|SUPERIORITY_OR_OTHER|||||||0.009||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50 mg/Placebo, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor||||0.009
71041875|NCT00401245|141593018|SUPERIORITY_OR_OTHER|||||||0.078|TWO_SIDED|||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50 mg QOD, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.||||0.078
71041876|NCT00401245|141593018|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50/25 mg, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.||||0.005
71041877|NCT00401245|141593018|SUPERIORITY_OR_OTHER|||||||0.929||95.0||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50mg/Placebo, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.||||0.929
71041878|NCT00401245|141593020|SUPERIORITY_OR_OTHER|||||||0.017||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|Chi-squared|||Overall comparison was made between each titration regimen and the control regimen (100 mg).||||0.017
71041879|NCT00401245|141593027|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|t-test, 2 sided|||Comparison was made between the difference in the means from the baseline value and post-baseline (Week 4) value with 0.||||<0.001
71041880|NCT00401245|141593027|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|t-test, 2 sided|||Comparison was made between the difference in the means from the baseline value and post-baseline (Week 8) value with 0.||||< 0.001
70999685|NCT00861380|141506454|OTHER|In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =229978.|PYAR|702.245|||||TWO_SIDED|95.0|700.372|704.114|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for Acute Otitis Media (AOM)/Respiratory Tract Infections (RTI), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||704.114|700.372|
70999686|NCT00861380|141506454|OTHER|In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =120190.|PYAR|720.9|||||TWO_SIDED|95.0|718.355|723.435|||negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||723.435|718.355|
70999687|NCT00861380|141506454|OTHER|In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =214181.|PYAR|929.844|||||TWO_SIDED|95.0|928.755|930.923|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||930.923|928.755|
70999688|NCT00861380|141506454|OTHER|In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =112060.|PYAR|953.025|||||TWO_SIDED|95.0|951.77|954.257|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||954.257|951.770|
70999689|NCT00861380|141506454|OTHER|In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =214181.|PYAR|804.703|||||TWO_SIDED|95.0|803.017|806.38|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||806.380|803.017|
70999690|NCT00861380|141506454|OTHER|In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =112060.|PYAR|818.66|||||TWO_SIDED|95.0|816.391|820.912|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||820.912|816.391|
71008600|NCT02055976|141525231|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-51.5|STANDARD_ERROR_OF_MEAN|3.305|<|0.001|TWO_SIDED|95.0|-58.063|-44.937|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-44.937|-58.063|<0.001
70999691|NCT00861380|141506454|OTHER|In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =211914.|PYAR|916.079|||||TWO_SIDED|95.0|914.891|917.256|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||917.256|914.891|
70999692|NCT00861380|141506454|OTHER|In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111071.|PYAR|928.568|||||TWO_SIDED|95.0|927.038|930.076|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||930.076|927.038|
70999693|NCT00861380|141506454|OTHER|In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =211914.|PYAR|796.894||||||95.0|795.175|798.605|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||798.605|795.175|
70999694|NCT00861380|141506454|OTHER|In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111071.|PYAR|803.918|||||TWO_SIDED|95.0|801.571|806.25|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||806.250|801.571|
70999695|NCT00861380|141506454|OTHER|In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =213913.|PYAR|865.679|||||TWO_SIDED|95.0|864.227|867.121|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||867.121|864.227|
70999696|NCT00861380|141506454|OTHER|In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111414.|PYAR|871.749|||||TWO_SIDED|95.0|869.771|873.707|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||873.707|869.771|
70999697|NCT00861380|141506454|OTHER|In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =213913.|PYAR|753.423|||||TWO_SIDED|95.0|751.591|755.249|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||755.249|751.591|
71041881|NCT00401245|141593027|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|t-test, 2 sided|||Comparison was made between the difference in the means from the base value and post-baseline (Week 12) value with 0.||||<0.001
71041882|NCT00401245|141593027|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|t-test, 2 sided|||Comparison was made between the difference in the means from the baseline value and post-baseline (Week 16) value with 0.||||<0.001
71041883|NCT02344745|141593030|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
71041884|NCT02344745|141593031|SUPERIORITY_OR_OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.70
71041885|NCT02344745|141593032|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71041886|NCT02344745|141593033|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.50
71041887|NCT02788513|141593034|OTHER|||||||0.9931||||||An alpha of 0.05 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod Beta model fit.|Model assumption: 75% of max effect is achieved at 2 mg, 87.5% at 5 mg, 25% at 25 mg, max effect achieved at 10 mg of BI 425809, scalar parameter = 26||Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.||||0.9931
71041888|NCT02788513|141593034|OTHER|||||||0.9225||||||An alpha of 0.05 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod Emax model fit.|Model assumption: 20% of the maximum effect is achieved at 2 mg||Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.||||0.9225
71041889|NCT02788513|141593034|OTHER|||||||0.9287||||||An alpha of 0.05 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod Sigmoidal Emax model fit.|Model assumption: 25% of max effect achieved at 5 mg and 75% of max effect achieved at 10 mg of BI 425809.||Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.||||0.9287
71041890|NCT02788513|141593034|OTHER|||||||0.7646||||||An alpha of 0.05 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod linear model fit.|No assumption needed.||Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.||||0.7646
70923936|NCT03978871|141339897|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.048|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD involuntary dysregulation scores from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.048
71041891|NCT02788513|141593034|OTHER|||||||0.9335||||||An alpha of 0.05 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod linear in log model fit.|No assumption needed.||Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.||||0.9335
71041892|NCT02788513|141593034|OTHER|||||||0.8199||||||An alpha of 0.05 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod logistic model fit.|Model assumption: 10% of max effect achieved at 5 mg and 50% of max effect achieved at 10 mg of BI 425809.||Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.||||0.8199
71041893|NCT02788513|141593034|OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.58||0.934|TWO_SIDED|95.0|-1.09|1.18||p-values are nominal without multiplicity adjustment.|MMRM|MMRM information is described in the description section.||Mixed model repeated measures (MMRM)||1.18|-1.09|0.9340
71041894|NCT02788513|141593034|OTHER||Median Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.58||0.6041|TWO_SIDED|95.0|-0.84|1.44||p-values are nominal without multiplicity adjustment.|MMRM|MMRM information is described in the description section.||Mixed model repeated measures (MMRM)||1.44|-0.84|0.6041
71041895|NCT02788513|141593034|OTHER||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.58||0.1926|TWO_SIDED|95.0|-0.38|1.9||p-values are nominal without multiplicity adjustment.|MMRM|MMRM information is described in the description section.||Mixed model repeated measures (MMRM)||1.90|-0.38|0.1926
71041896|NCT02788513|141593034|OTHER||Median Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.58||0.9739|TWO_SIDED|95.0|-1.16|1.12||p-values are nominal without multiplicity adjustment.|MMRM|MMRM information is described in the description section.||Mixed model repeated measures (MMRM)||1.12|-1.16|0.9739
71100486|NCT02732145|141709668|SUPERIORITY|"Question: Is there a difference in the frequency of P-#-# result (specific lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.0019|||||||t-test proportion|||"Parameter: The difference in the frequency of P-#-# result (specific lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.0019
71041897|NCT02788513|141593035|OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.76||0.979|TWO_SIDED|95.0|-1.48|1.52||p-values are nominal without multiplicity adjustment.|ANCOVA|Analysis of Covariance model included baseline value for the secondary endpoint measure, MMSE stratification (\>=20, \<20) at baseline and treatment.||Analysis of Covariance (ANCOVA)||1.52|-1.48|0.979
71041898|NCT02788513|141593035|OTHER||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.77||0.521|TWO_SIDED|95.0|-1.01|2.0||p-values are nominal without multiplicity adjustment.|ANCOVA|Analysis of Covariance model included baseline value for the secondary endpoint measure, MMSE stratification (\>=20, \<20) at baseline and treatment.||Analysis of Covariance (ANCOVA)||2.00|-1.01|0.521
71041899|NCT02788513|141593035|OTHER||Mean Difference (Final Values)|-1.53|STANDARD_ERROR_OF_MEAN|0.77||0.047|TWO_SIDED|95.0|-3.04|-0.02||p-values are nominal without multiplicity adjustment.|ANCOVA|Analysis of Covariance model included baseline value for the secondary endpoint measure, MMSE stratification (\>=20, \<20) at baseline and treatment.||Analysis of Covariance (ANCOVA)||-0.02|-3.04|0.047
71041900|NCT02788513|141593035|OTHER||Mean Difference (Final Values)|-2.16|STANDARD_ERROR_OF_MEAN|0.76||0.005|TWO_SIDED|95.0|-3.65|-0.67||p-values are nominal without multiplicity adjustment.|ANCOVA|Analysis of Covariance model included baseline value for the secondary endpoint measure, MMSE stratification (\>=20, \<20) at baseline and treatment.||Analysis of Covariance (ANCOVA)||-0.67|-3.65|0.005
71041901|NCT02788513|141593036|OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.343|TWO_SIDED|95.0|-0.32|0.11||p-values are nominal without multiplicity adjustment.|ANCOVA|ANCOVA included MMSE stratification (\>=20, \<20) at baseline (BL) and treatment, CIBIS is included as BL adjustment term.||Analysis of Covariance (ANCOVA)||0.11|-0.32|0.343
70999698|NCT00861380|141506454|OTHER|In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111414.|PYAR|755.542|||||TWO_SIDED|95.0|753.008|758.064|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||758.064|753.008|
70999699|NCT00637377|141506462|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set to 10. The power is 90 % according to the sample size estimation of the study protocol.|Risk Difference (RD)|-1.2|||||TWO_SIDED|95.0|-4.86|2.46|||||The difference is calculated as Ranibizumab minus Aflibercept. A negative value favors the Aflibercept 2mg Q4 group. As adjustment of multiple comparisons a conditional sequence of statistical hypotheses is used with alpha = 0.05.|null hypothesis: pi ≤ pc-delta where pi is the probability that a participant maintained vision at week 52 under Aflibercept 2mg Q4, pc is the probability that a participant maintained vision at week 52 under Ranibizumab 0.5mg Q4 and delta is the non-inferiority margin. The null hypothesis is tested calculating a two-sided 95 % confidence using normal approximation of the difference of percentages of participants maintaining vision at week 52 (Ranibizumab 0.5mg Q4 minus Aflibercept 2mg Q4).||2.46|-4.86|
70999700|NCT00637377|141506462|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set to 10. The power is 90 % according to the sample size estimation of the study protocol.|Risk Difference (RD)|-1.84|||||TWO_SIDED|95.0|-5.4|1.71|||||The difference is calculated as Ranibizumab minus Aflibercept. A negative value favors the Aflibercept 0.5mg Q4 group. As adjustment of multiple comparisons a conditional sequence of statistical hypotheses is used with alpha = 0.05.|null hypothesis: pi ≤ pc-delta where pi is the probability that a participant maintained vision at week 52 under Aflibercept 0.5mg Q4, pc is the probability that a participant maintained vision at week 52 under Ranibizumab 0.5mg Q4 and delta is the non-inferiority margin. The null hypothesis is tested calculating a two-sided 95 % confidence using normal approximation of the difference of percentages of participants maintaining vision at week 52 (Ranibizumab 0.5mg Q4 minus Aflibercept 0.5mg Q4).||1.71|-5.40|
70999701|NCT00637377|141506462|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set to 10. The power is 90 % according to the sample size estimation of the study protocol.|Risk Difference (RD)|-1.13|||||TWO_SIDED|95.0|-4.81|2.55|||||The difference is calculated as Ranibizumab minus Aflibercept. A negative value favors the Aflibercept 2mg Q8 group. As adjustment of multiple comparisons a conditional sequence of statistical hypotheses is used with alpha = 0.05.|null hypothesis: pi ≤ pc-delta where pi is the probability that a participant maintained vision at week 52 under Aflibercept 2mg Q8, pc is the probability that a participant maintained vision at week 52 under Ranibizumab 0.5mg Q4 and delta is the non-inferiority margin. The null hypothesis is tested calculating a two-sided 95 % confidence using normal approximation of the difference of percentages of participants maintaining vision at week 52 (Ranibizumab 0.5mg Q4 minus Aflibercept 2mg Q8).||2.55|-4.81|
70999702|NCT00637377|141506463|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-1.9484||||0.076|TWO_SIDED|95.0|-4.1009|0.204||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors Aflibercept 2mg Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline ETDRS letter score as covariate. The null hypothesis is that both mean changes are equal.||0.2040|-4.1009|0.076
70999703|NCT00637377|141506463|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.062||||0.9555|TWO_SIDED|95.0|-2.2398|2.1158||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors Aflibercept 0.5mg Q4|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline ETDRS letter score as covariate. The null hypothesis is that both mean changes are equal.||2.1158|-2.2398|0.9555
71008601|NCT02055976|141525231|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.474|STANDARD_ERROR_OF_MEAN|3.547|<|0.001|TWO_SIDED|95.0|-47.523|-33.426|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-33.426|-47.523|<0.001
71100487|NCT02732145|141709668|SUPERIORITY|"Question: Is there a difference in the frequency of #-N-# result (no lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.6541|||||||t-test proportion|||"Parameter: The difference in the frequency of #-N-# result (no lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.6541
70923937|NCT03978871|141339897|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.266|||||||ANCOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD involuntary dysregulation scores from time 1 to time 2. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.266
70923938|NCT03978871|141339897|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.402|||||||ANOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD disengagement scores from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.402
70923939|NCT03978871|141339898|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.363|||||||ANOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD proactive engagement from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.363
70999704|NCT00637377|141506463|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.9014||||0.4131|TWO_SIDED|95.0|-3.0615|1.2587||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors the Aflibercept 2mg Q8 group|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline ETDRS letter score as covariate. The null hypothesis is that both mean changes are equal.||1.2587|-3.0615|0.4131
70999705|NCT00637377|141506464|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.57||||0.229|TWO_SIDED|95.0|-12.02|2.88||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|Chi-squared||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors the Aflibercept 2mg Q4 group|The null hypothesis is that the two proportions are equal.||2.88|-12.02|0.229
70999706|NCT00637377|141506464|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.78||||0.843|TWO_SIDED|95.0|-6.91|8.46||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|Chi-squared||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors the Aflibercept 0.5mg Q4 group|The null hypothesis is that the two proportions are equal.||8.46|-6.91|0.843
70999707|NCT00637377|141506464|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.65||||0.49|TWO_SIDED|95.0|-10.18|4.88||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|Chi-squared||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors the Aflibercept 2mg Q8 group|The null hypothesis is that the two proportions are equal.||4.88|-10.18|0.490
70999708|NCT00637377|141506465|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-2.7885||||0.0097|TWO_SIDED|95.0|-4.9012|-0.6757||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors Aflibercept 2mg Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline NEI VFQ-25 total score as covariate. The null hypothesis is that both mean changes are equal.||-0.6757|-4.9012|0.0097
70999709|NCT00637377|141506465|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.932||||0.3917|TWO_SIDED|95.0|-3.0658|1.2019||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors Aflibercept 0.5mg Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline NEI VFQ-25 total score as covariate. The null hypothesis is that both mean changes are equal.||1.2019|-3.0658|0.3917
70999710|NCT00637377|141506465|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-1.947||||0.0717|TWO_SIDED|95.0|-4.0659|0.1718||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors Aflibercept 2mg Q8.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline NEI VFQ-25 total score as covariate. The null hypothesis is that both mean changes are equal.||0.1718|-4.0659|0.0717
70999711|NCT00637377|141506466|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-1.18||||0.0038|TWO_SIDED|95.0|-1.979|-0.382||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A negative value favors Aflibercept 2mg Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline CNV area as covariate. The null hypothesis is that both mean changes are equal.||-0.382|-1.979|0.0038
70999712|NCT00637377|141506466|SUPERIORITY_OR_OTHER||Differences in Least Squares means|0.17||||0.6784|TWO_SIDED|95.0|-0.632|0.972||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A negative value favors Aflibercept 0.5mg Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline CNV area as covariate. The null hypothesis is that both mean changes are equal.||0.972|-0.632|0.6784
71041902|NCT02788513|141593036|OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.11||0.645|TWO_SIDED|95.0|-0.26|0.16||p-values are nominal without multiplicity adjustment.|ANCOVA|ANCOVA included MMSE stratification (\>=20, \<20) at baseline (BL) and treatment, CIBIS is included as BL adjustment term.||Analysis of Covariance (ANCOVA)||0.16|-0.26|0.645
71041903|NCT02788513|141593036|OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.11||0.448|TWO_SIDED|95.0|-0.13|0.3||p-values are nominal without multiplicity adjustment.|ANCOVA|ANCOVA included MMSE stratification (\>=20, \<20) at baseline (BL) and treatment, CIBIS is included as BL adjustment term.||Analysis of Covariance (ANCOVA)||0.30|-0.13|0.448
70923940|NCT03978871|141339898|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.363|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD involuntary dysregulation scores from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.363
70999713|NCT00637377|141506466|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.733||||0.0727|TWO_SIDED|95.0|-1.534|0.068||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A negative value favors Aflibercept 2mg Q8.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline CNV area as covariate. The null hypothesis is that both mean changes are equal.||0.068|-1.534|0.0727
70999714|NCT00631540|141506478|SUPERIORITY_OR_OTHER||Mean Patency Rate|91.7|||<|0.0001|TWO_SIDED|95.0|84.2|95.9|||Z-test, 1-sided||GEE model estimate.|Alternative hypothesis is 9-month primary patency rate greater than 60%.||95.9|84.2|<0.0001
70999715|NCT03136367|141506541|SUPERIORITY|||||||0.045||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.045
70999716|NCT03136367|141506541|SUPERIORITY|||||||0.2||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.20
70999717|NCT03136367|141506541|SUPERIORITY|||||||0.82||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.82
70999718|NCT03136367|141506542|SUPERIORITY|||||||0.048||||||Adjusted for repeated within-patient measurements|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.048
71041904|NCT02788513|141593036|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.11||0.34|TWO_SIDED|95.0|-0.11|0.32||p-values are nominal without multiplicity adjustment.|ANCOVA|ANCOVA included MMSE stratification (\>=20, \<20) at baseline (BL) and treatment, CIBIS is included as BL adjustment term.||Analysis of Covariance (ANCOVA)||0.32|-0.11|0.340
71041905|NCT01933919|141593089|SUPERIORITY||LS Mean Difference (Fluvoxamine-Placebo)|-4.3|STANDARD_ERROR_OF_MEAN|2.07||0.044|TWO_SIDED|95.0|-8.5|-0.1|||ANCOVA|ANCOVA with baseline JCY-BOCS (10-item) total score and age as covariates and treatment as fixed effect.|The model included the fixed effects of treatment, with baseline JCY-BOCS (10-item) total score and age as covariates.|||-0.1|-8.5|0.044
71041906|NCT00991510|141593101|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was accepted if the calculated 90 % CIs were within 0.80-1.25.|adjusted least-squares mean ratio|0.923|||||TWO_SIDED|90.0|0.865|0.984|||ANOVA|||A total of 100 subjects were planned to be enrolled, allowing for 10% drop-out rate. Based on previous single dose studies, the intra-subject coefficients of variation were 14% and 50% for AUC and Cmax, respectively. Based on the literature similar intra subject coefficients of variation were observed in steady-state patients. With these expected CV(%) and an expected ratio of Cmax within 0.95 and 1.05, the study should have a power of at least 80 % to show bioequivalence with 80 subjects.||0.984|0.865|
71041907|NCT00991510|141593102|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was accepted if the calculated 90 % CIs were within 0.80-1.25.|adjusted least-squares mean ratio|0.959|||||TWO_SIDED|90.0|0.899|1.023|||ANOVA|||||1.023|0.899|
71100488|NCT02732145|141709668|SUPERIORITY|"Question: Is there a difference in the frequency of #-S-# result (non-specific lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8224|||||||t-test proportion|||"Parameter: The difference in the frequency of #-S-# result (non-specific lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8224
71100489|NCT02732145|141709668|SUPERIORITY|"Question: Is there a difference in the frequency of #-P-# result (specific lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.0064|||||||t-test proportion|||"Parameter: The difference in the frequency of #-P-# result (specific lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.0064
70923941|NCT03978871|141339898|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.583|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD involuntary dysregulation scores from time 1 to time 3. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.583
70923942|NCT03978871|141339898|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.379|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD disengagement scores from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.379
70999719|NCT03136367|141506542|SUPERIORITY|||||||0.015||||||Adjusted for repeated within-patient measurements|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.015
70999720|NCT03136367|141506542|SUPERIORITY|||||||0.43||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.43
70999721|NCT03136367|141506543|SUPERIORITY|||||||0.46|||||||Mixed Models Analysis|Mixed effects linear regression that accounted clustering and was adjusted for surgeon and patient characteristics.||||||0.46
70999722|NCT03136367|141506543|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|Mixed effects linear regression that accounted clustering and was adjusted for surgeon and patient characteristics.||||||0.34
70999723|NCT03136367|141506543|SUPERIORITY|||||||0.165|||||||Mixed Models Analysis|Mixed effects linear regression that accounted clustering and was adjusted for surgeon and patient characteristics.||||||0.165
70999724|NCT03136367|141506545|SUPERIORITY|||||||0.25||||||Adjusted for repeated within-patient measurements|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.25
71041908|NCT00991510|141593103|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was accepted if the calculated 90 % CIs were within 0.80-1.25.|adjusted least-squares mean ratio|0.873|||||TWO_SIDED|90.0|0.787|0.968|||ANOVA|||||0.968|0.787|
70923943|NCT03978871|141339898|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.246|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD disengagement scores from time 1 to time 3. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.246
70923944|NCT03978871|141339899|SUPERIORITY|Data were collected using a Siemens Prisma MRI 3T scanner and preprocessed with fMRIprep. 12 ROI masks were generated from the CON network of a modified Schaefer atlas. First-level contrast estimates (negative reframe \> negative immerse) for each voxel within each ROI were averaged with MarsBaR to produce 12 values for each person. These were then averaged to produce a single value each.A two-sample t-test was conducted in R to test for differences across intervention groups (mindset vs control)||||||0.455||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(146) = .75||||||0.455
70923945|NCT03978871|141339900|SUPERIORITY|Data were collected using a Siemens Prisma MRI 3T scanner and preprocessed with fMRIprep. 12 ROI masks were generated from the CON network of a modified Schaefer atlas. First-level contrast estimates (negative \> neutral) for each voxel within each ROI were averaged with MarsBaR to produce 12 values for each person. These were subsequently averaged to produce a single value per person. A two-sample t-test was conducted in R to test for differences across intervention groups (mindset vs control).||||||0.43||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(145) = 0.80||||||0.43
70923946|NCT03978871|141339901|SUPERIORITY|BOLD signals were spatially averaged within ROIs to produce a single time series for each ROI. Timeseries were averaged to produce a single value representing each ROI's mean activity. Values for each ROI were then averaged to produce a single value per person representing mean network activity. These values were then submitted to a two-sample t-test to test for differences across intervention groups (mindset vs control).||||||0.29||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(142) = -1.057||||||0.29
70999725|NCT03136367|141506545|SUPERIORITY|||||||0.89||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.89
70999726|NCT03136367|141506545|SUPERIORITY|||||||0.54||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.54
70999727|NCT03136367|141506546|SUPERIORITY|||||||0.72||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.72
70999728|NCT03136367|141506546|SUPERIORITY|||||||0.41||||||Adjusted for repeated within-patient measurements.|McNemar|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.41
70999729|NCT03136367|141506546|SUPERIORITY|||||||0.28||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.28
70999730|NCT03136367|141506547|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.01
70999731|NCT03136367|141506547|SUPERIORITY|||||||0.12|||||||Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.12
70999732|NCT03136367|141506547|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.78
70999733|NCT03136367|141506548|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||<0.01
70999734|NCT03136367|141506548|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||<0.01
70999735|NCT03136367|141506549|SUPERIORITY|||||||0.06||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.06
70999736|NCT03136367|141506549|SUPERIORITY|||||||0.65||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.65
70923947|NCT03978871|141339902|SUPERIORITY|Data were preprocessed in fMRIprep. Separate right/left amygdala seeds were defined with the AAL1 atlas. Interaction regressors were created between seeds and task conditions. Average contrast estimates for interaction terms of relevant trials (negative reframe \> negative immerse) were extracted with MarsBaR from 12 ROIs in the CON of a modified Schaefer atlas and the 24 values averaged. A two-sample t-test was conducted in R to compare average connectivity between groups (mindset vs control).||||||0.88||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(146) = 0.148||||||0.88
70923948|NCT03978871|141339903|SUPERIORITY|Data were preprocessed in fMRIprep. Separate right/left amygdala seeds were defined with the AAL1 atlas. Interaction regressors were created between seeds and task conditions. Average contrast estimates for interaction terms of relevant trials (negative \> neutral) were extracted with MarsBaR from 12 ROIs in the CON of a modified Schaefer atlas and the 24 values averaged. A two-sample t-test was conducted in R to compare average connectivity between groups (mindset vs control).||||||0.11||||||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|t(145) = 1.631||||||.11
70999737|NCT03136367|141506549|SUPERIORITY|||||||0.36||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.36
70999738|NCT03136367|141506550|SUPERIORITY|||||||0.11||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.11
70999739|NCT03136367|141506550|SUPERIORITY|||||||0.037||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.037
70999740|NCT03136367|141506550|SUPERIORITY|||||||0.28||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.28
70999741|NCT02823080|141506607|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70999742|NCT02823080|141506608|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70999743|NCT02823080|141506609|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70999744|NCT02823080|141506613|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70999745|NCT00676208|141506614|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.04
70999746|NCT00676208|141506615|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.04
70999747|NCT04532918|141506616|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|255.3|||||TWO_SIDED|90.0|208.7|312.3|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of Cmax||312.3|208.7|
70999748|NCT04532918|141506616|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|189.5|||||TWO_SIDED|90.0|154.0|233.1|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of Cmax||233.1|154.0|
70999749|NCT04532918|141506617|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|238.4|||||TWO_SIDED|90.0|207.6|273.8|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUCinf||273.8|207.6|
70999750|NCT04532918|141506617|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|148.9|||||TWO_SIDED|90.0|129.1|171.7|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUCinf||171.7|129.1|
70923949|NCT03978871|141339904|SUPERIORITY|BOLD signals were spatially averaged within ROIs to produce a single time series for each ROI. Pearson correlations were calculated between each mean BOLD signal in the CON and each amygdala ROI to produce 24 connectivity values. These were averaged to produce a single value representing the strength of coupling of the CON network to the amygdala for each participant. These values were then submitted to a two-sample t-test to test for differences across intervention groups (mindset vs control).||||||0.92||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(142) = 0.101||A two-sample t-test was conducted to compare average connectivity (between the amygdala and the CON network) during resting state between the mindset and control groups.||||0.92
70999751|NCT04532918|141506618|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|261.8|||||TWO_SIDED|90.0|229.8|298.1|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUClast||298.1|229.8|
70999752|NCT04532918|141506618|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|163.2|||||TWO_SIDED|90.0|142.8|186.6|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUClast||186.6|142.8|
70999753|NCT04532918|141506619|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|273.4|||||TWO_SIDED|90.0|227.9|328.1|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of Cmax for metabolite: M1||328.1|227.9|
70999754|NCT04532918|141506619|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|275.9|||||TWO_SIDED|90.0|228.7|332.7|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of Cmax for metabolite: M1||332.7|228.7|
70999755|NCT04532918|141506619|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|24.65|||||TWO_SIDED|90.0|19.15|31.72|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of Cmax for metabolite: M8||31.72|19.15|
70999756|NCT04532918|141506619|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|37.82|||||TWO_SIDED|90.0|29.18|49.03|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of Cmax for metabolite: M8||49.03|29.18|
70999757|NCT04532918|141506620|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|291.8|||||TWO_SIDED|90.0|260.6|326.8|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for metabolite: M1||326.8|260.6|
70999758|NCT04532918|141506620|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|215.8|||||TWO_SIDED|90.0|192.0|242.4|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of Cmax for metabolite: M1||242.4|192.0|
70999759|NCT04532918|141506620|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|55.31|||||TWO_SIDED|90.0|47.19|64.83|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for metabolite: M8||64.83|47.19|
70999760|NCT04532918|141506620|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|68.28|||||TWO_SIDED|90.0|57.99|80.39|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for metabolite: M8||80.39|57.99|
71041909|NCT00991510|141593104|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was accepted if the calculated 90 % CIs were within 0.80-1.25.|adjusted least-squares mean ratio|0.985|||||TWO_SIDED|90.0|0.877|1.106|||ANOVA|||||1.106|0.877|
70999761|NCT04532918|141506621|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|306.4|||||TWO_SIDED|90.0|273.3|343.6|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUClast for metabolite: M1||343.6|273.3|
70999762|NCT04532918|141506621|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|227.4|||||TWO_SIDED|90.0|202.1|255.8|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUClast for metabolite: M1||255.8|202.1|
70999763|NCT04532918|141506621|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|51.03|||||TWO_SIDED|90.0|43.8|59.45|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUClast for metabolite: M8||59.45|43.80|
70999764|NCT04532918|141506621|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|70.45|||||TWO_SIDED|90.0|60.21|82.44|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUClast for metabolite: M8||82.44|60.21|
70999765|NCT04532918|141506622|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|74.84|||||TWO_SIDED|90.0|59.42|94.26|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of Cmax for allopurinol||94.26|59.42|
70999766|NCT04532918|141506622|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|80.99|||||TWO_SIDED|90.0|63.88|102.7|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of Cmax for allopurinol||102.7|63.88|
70999767|NCT04532918|141506622|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|96.86|||||TWO_SIDED|90.0|92.11|101.8|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of Cmax for oxypurinol||101.8|92.11|
70999768|NCT04532918|141506622|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|99.07|||||TWO_SIDED|90.0|94.36|104.0|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of Cmax for oxypurinol||104.0|94.36|
70999769|NCT04532918|141506623|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|98.29|||||TWO_SIDED|90.0|91.26|105.9|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for allopurinol||105.9|91.26|
70999770|NCT04532918|141506623|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|101.2|||||TWO_SIDED|90.0|93.72|109.2|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for allopurinol||109.2|93.72|
70999771|NCT04532918|141506623|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|99.16|||||TWO_SIDED|90.0|95.02|103.5|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for oxypurinol||103.5|95.02|
70999772|NCT04532918|141506623|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|96.05|||||TWO_SIDED|90.0|92.15|100.1|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for oxypurinol||100.1|92.15|
70999773|NCT04532918|141506624|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|98.25|||||TWO_SIDED|90.0|91.1|106.0|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUClast for allopurinol||106.0|91.10|
70999774|NCT04532918|141506624|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|101.6|||||TWO_SIDED|90.0|93.99|109.8|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUClast for allopurinol||109.8|93.99|
70999775|NCT04532918|141506624|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|98.05|||||TWO_SIDED|90.0|94.5|101.7|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUClast for oxypurinol||101.7|94.50|
70999776|NCT04532918|141506624|OTHER||Geometric Mean Ratio (%)|95.98|||||TWO_SIDED|90.0|92.61|99.48|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects||99.48|92.61|
70999777|NCT02564029|141506637|OTHER||Mean Difference (Final Values)|-6.23|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|90.0|-8.6|-3.86|||Mixed Model Repeated Measures Analysis|||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.||-3.86|-8.60|
70999778|NCT02564029|141506637|OTHER||Mean Difference (Final Values)|-5.42|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|90.0|-7.78|-3.06|||Mixed Model Repeated Measures Analysis|||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.||-3.06|-7.78|
70923950|NCT03978871|141339905|OTHER|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative immerse \> neutral immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005. The WFU PickAtlas via xjview was used to determine anatomical localization for surviving clusters.||||||2.22e-05||||||Reported result for cluster localized in the Superior/Middle Temporal Gyrus (Right). FWE-corrected p-value is reported. pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 278 voxels.|t-test, 2 sided|||||||.0000222
70999779|NCT02564029|141506637|OTHER||Mean Difference (Final Values)|-5.22|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|90.0|-7.6|-2.84|||Mixed Model Repeated Measures Analysis|||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.||-2.84|-7.60|
70999780|NCT02564029|141506637|OTHER||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|1.38|||TWO_SIDED|90.0|-1.58|3.2|||Mixed Model Repeated Measures Analysis|||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.||3.20|-1.58|
70999781|NCT02564029|141506637|OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|90.0|-3.43|1.41|||Mixed Model Repreated Measure Analysis|||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.||1.41|-3.43|
70999782|NCT02564029|141506637|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|90.0|-2.56|2.16|||Mixed Model Repeated Measures Analysis|||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.||2.16|-2.56|
70999783|NCT02564029|141506638|OTHER||Mean Difference (Final Values)|-6.23|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|90.0|-8.6|-3.86|||Mixed Model Repeated Measure Analysis|||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-3.86|-8.60|
70999784|NCT02564029|141506638|OTHER||Mean Difference (Final Values)|-5.42|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|90.0|-7.78|-3.06|||Mixed Model Repeated Measures Analysis|||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-3.06|-7.78|
70999785|NCT02564029|141506638|OTHER||Mean Difference (Final Values)|-5.22|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|90.0|-7.6|-2.84|||Mixed Model Repeated Measures Analysis|||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-2.84|-7.60|
70999786|NCT02564029|141506638|OTHER||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|1.38|||TWO_SIDED|90.0|-1.58|3.2|||Mixed Model Repeated Measures Analysis|||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||3.20|-1.58|
70999787|NCT02564029|141506638|OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|90.0|-3.43|1.41|||Mixed Model Repeated Measures Analysis|||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||1.41|-3.43|
70999788|NCT02564029|141506638|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|90.0|-2.56|2.16|||Mixed Model Repeated Measures Analysis|||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||2.16|-2.56|
71041910|NCT03244475|141593201|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.|Mean Difference (Final Values)|1.6||||0.01|TWO_SIDED|95.0|1.1|2.2||The corrected p-value of 0.01 was chosen after the standard cluster analysis for correcting family-wise error across different voxels.|Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||The analysis was performed for the voxel-wise delta-band activity from the frontal pole and inferior frontal gyri. Spatial smoothing and logarithm transformation (e-based) were performed. Resting-state MEG activity differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||2.2|1.1|0.01
70923951|NCT03978871|141339905|SUPERIORITY|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative immerse \> neutral immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005. The WFU PickAtlas via xjview was used to determine anatomical localization for surviving clusters.||||||1.17e-05||||||Reported result for cluster localized in the Middle Temporal Gyrus (Left). FWE-corrected p-value is reported. pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 278 voxels.|t-test, 2 sided|||||||.0000117
71041911|NCT03244475|141593202|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
71041912|NCT03244475|141593203|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
71100490|NCT02732145|141709668|SUPERIORITY|"Question: Is there a difference in the frequency of #-#-N result (no lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.9723|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-N result (no lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.9723
71100491|NCT02732145|141709668|SUPERIORITY|"Question: Is there a difference in the frequency of #-#-S result (non-specific lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8161|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-S result (non-specific lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8161
71100492|NCT02732145|141709668|SUPERIORITY|"Question: Is there a difference in the frequency of #-#-P result (specific lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.1165|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-P result (specific lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.1165
71100493|NCT02732145|141709668|SUPERIORITY|"Question: Is there a difference in the frequency of N-N-N result (no lesions) in any of the Three Vulvar Rings in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.6339|||||||t-test proportion|||"Parameter: The difference in the frequency of N-N-N result (no lesions) in any of the Three Vulvar Rings in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.6339
71100494|NCT02732145|141709668|SUPERIORITY|"Question: Is there a difference in the frequency of S result (non-specific lesions) in any of the Three Vulvar Rings (S-#-#; S-S-#; S-S-S; S-N-S etc.) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.9724|||||||t-test proportion|||"Parameter: The difference in the frequency of S result (non-specific lesions) in any of the Three Vulvar Rings (S-#-#; S-S-#; S-S-S; S-N-S etc.) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.9724
71100495|NCT02732145|141709668|SUPERIORITY|"Question: Is there a difference in the frequency of P result (specific lesions) in any of the Three Vulvar Rings (P-#-#; P-P-; P-P-P; P-N-S etc.) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.0016|||||||t-test proportion|||"Parameter: The difference in the frequency of P result (specific lesions) in any of the Three Vulvar Rings (P-#-#; P-P-; P-P-P; P-N-S etc.) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.0016
71041913|NCT03244475|141593204|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
71100496|NCT02732145|141709669|EQUIVALENCE|Question: Is there a difference in the age of patients from different groups?||||||0|||||||ANOVA|||Parameter: The difference in the age of patients from different groups.||||0.0000
71100497|NCT02732145|141709670|EQUIVALENCE|Is there a difference in the weight of patients from different groups?||||||0|||||||ANOVA|||The difference in the weight of patients from different groups.||||0.0000
71100498|NCT02732145|141709671|EQUIVALENCE|Is there a difference in the height of patients from different groups.||||||0.0557|||||||ANOVA|||The difference in the height of patients from different groups.||||0.0557
71100499|NCT02732145|141709672|EQUIVALENCE|Is there a difference in the body mass index of patients from different groups.||||||0|||||||ANOVA|||The difference in the body mass index of patients from different groups.||||0.0000
71100500|NCT02732145|141709673|EQUIVALENCE|Question: Is there a difference in the incidence of patients older than 65 years in different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of patients older than 65 years between different groups.||||0.0000
71041914|NCT03244475|141593205|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
71041915|NCT03244475|141593206|SUPERIORITY|Statistical analysis was carried out for the DIFFERENCE scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
71100501|NCT02732145|141709673|EQUIVALENCE|Question: Is there a difference in the incidence of menopausal patients among different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of menopausal patients among different groups.||||0.0000
70923952|NCT03978871|141339905|SUPERIORITY|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative immerse \> neutral immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005. The WFU PickAtlas via xjview was used to determine anatomical localization for surviving clusters.||||||0||||||"Reported result for cluster localized in the Anterior Cingulate/Medial Frontal Gyrus.~FWE-corrected p-value is reported. pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 278 voxels."|t-test, 2 sided|||||||.000000000
70999789|NCT02564029|141506638|OTHER||Mean Difference (Final Values)|-6.51|STANDARD_ERROR_OF_MEAN|0.79|||TWO_SIDED|90.0|-8.01|-5.01|||Mixed Model Repeated Measures Analysis|||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-5.01|-8.01|
70999790|NCT02564029|141506638|OTHER||Mean Difference (Final Values)|-6.44|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|90.0|-7.93|-4.95|||Mixed Model Repeated Measures Analysis|||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-4.95|-7.93|
70999791|NCT02564029|141506638|OTHER||Mean Difference (Final Values)|-5.74|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|90.0|-7.2|-4.28|||Mixed Model Repeated Measures Analysis|||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-4.28|-7.20|
70999792|NCT02564029|141506638|OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.72|||TWO_SIDED|90.0|-1.31|1.46|||Mixed Model Repeated Measures Analysis|||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||1.46|-1.31|
70999793|NCT02564029|141506638|OTHER||Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|90.0|-2.19|0.65|||Mixed Model Repeated Measures Analysis|||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||0.65|-2.19|
70999794|NCT02564029|141506638|OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.72|||TWO_SIDED|90.0|-2.09|0.7|||Mixed Model Repeated Measures Analysis|||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||0.70|-2.09|
70999795|NCT02564029|141506638|OTHER||Mean Difference (Final Values)|-4.42|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|90.0|-5.6|-3.25|||Mixed Model Repeated Measures Analysis|||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-3.25|-5.60|
70999796|NCT02564029|141506638|OTHER||Mean Difference (Final Values)|-4.37|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|90.0|-5.57|-3.17|||Mixed Model Repeated Measures Analysis|||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-3.17|-5.57|
70999797|NCT02564029|141506638|OTHER||Mean Difference (Final Values)|-4.38|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|90.0|-5.57|-3.19|||Mixed Model Repeated Measures Analysis|||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-3.19|-5.57|
70999798|NCT02564029|141506638|OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|90.0|-1.08|1.19|||Mixed Model Repeated Measures Analysis|||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||1.19|-1.08|
70999799|NCT02564029|141506638|OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|90.0|-1.18|1.1|||Mixed Model Repeated Measures Analysis|||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||1.10|-1.18|
70999800|NCT02564029|141506638|OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|90.0|-1.11|1.13|||Mixed Model Repeated Measures Analysis|||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||1.13|-1.11|
70999801|NCT00617656|141506683|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.56|TWO_SIDED|95.0|0.76|1.67|||Log Rank|||This is a futility analysis. The initial hypothesis of the clinical trial was that the experimental group as a whole was superior to the control group.||1.67|0.76|0.56
70999802|NCT00617656|141506683|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.79|TWO_SIDED|95.0|0.73|1.51|||Log Rank|||||1.51|0.73|0.79
70999803|NCT00617656|141506683|SUPERIORITY||Hazard Ratio (HR)|2.02||||0.0001|TWO_SIDED|95.0|1.38|2.95|||Log Rank|||||2.95|1.38|0.0001
70999804|NCT00617656|141506684|SUPERIORITY||Hazard Ratio (HR)|1.55||||0.006|TWO_SIDED|95.0|1.13|2.12|||Log Rank|||||2.12|1.13|0.006
70999805|NCT02657434|141506697|OTHER|Unstratified Analysis|Hazard Ratio, log|0.562|||<|0.0001|TWO_SIDED|95.0|0.471|0.671|||Log Rank|||||0.671|0.471|<0.0001
70999806|NCT02657434|141506698|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.866||||0.1559|TWO_SIDED|95.0|0.709|1.056|||Log Rank|||||1.056|0.709|0.1559
70999807|NCT02657434|141506698|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.864||||0.1546|TWO_SIDED|95.0|0.707|1.056|||Log Rank|||||1.056|0.707|0.1546
70999808|NCT02657434|141506699|SUPERIORITY||Difference in event free rate|4.68||||0.2606|TWO_SIDED|95.0|-3.47|12.83|||z test|||||12.83|-3.47|0.2606
70999809|NCT02657434|141506700|SUPERIORITY||Difference in Event Free Rate|5.12||||0.209|TWO_SIDED|95.0|-2.87|13.11|||Z-test|||||13.11|-2.87|0.2090
70999810|NCT02657434|141506701|SUPERIORITY||Difference in response rate|14.3||||0.0005|TWO_SIDED|95.0|5.9|22.7|||Cochran-Mantel-Haenszel|||||22.7|5.9|0.0005
70999811|NCT02657434|141506702|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.0024|TWO_SIDED|95.0|0.45|0.85|||Log Rank|||||0.85|0.45|0.0024
70999812|NCT00608881|141506712|SUPERIORITY_OR_OTHER||π hat|0.494|||||TWO_SIDED|95.0|0.454|0.534|||||π hat is the estimate of the probability π that a randomly selected subject treated with CoQ has a better outcome than a randomly selected subject treated with placebo. Under the null hypothesis of no effect of CoQ, π = 0.50.|In this joint rank analysis, subjects are ranked from worst to best outcome with subjects who die being assigned the worst ranks (and ranked according to the time of death) and subjects who survive being ranked more favorably in the order of the change from baseline to Month 60 in TFC score.||0.534|0.454|
70999813|NCT00608881|141506713|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23|||||TWO_SIDED|95.0|-0.44|0.91||||||||0.91|-0.44|
71041916|NCT03244475|141593207|SUPERIORITY|Statistical analysis was carried out for the DIFFERENCE scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
71041917|NCT03244475|141593208|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
71041918|NCT03244475|141593209|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
71041919|NCT03244475|141593210|SUPERIORITY|Statistical analysis was carried out for the DIFFERENCE scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
71041920|NCT03244475|141593211|SUPERIORITY|Statistical analysis was carried out for the DIFFERENCE scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
71041921|NCT03244475|141593212|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
71041922|NCT02780167|141593217|OTHER||Estimate difference|1.8|STANDARD_ERROR_OF_MEAN|0.99||0.121|TWO_SIDED|95.0|-0.7|4.4|||Emax model|Emax model with non-responder imputation (NRI)|Test group: PF-04965842 10 mg QD, Reference group: Placebo.|||4.4|-0.7|0.1210
71041923|NCT02780167|141593217|OTHER||Estimate difference|6.0|STANDARD_ERROR_OF_MEAN|3.05||0.1065|TWO_SIDED|95.0|-1.8|13.8|||Emax model|Emax model with non-responder imputation (NRI)|Test group: PF-04965842 30 mg QD, Reference group: Placebo.|||13.8|-1.8|0.1065
71100502|NCT02732145|141709673|EQUIVALENCE|Question: Is there a difference in the incidence of domicile country (Croatia) as a country of birth among patients from different groups.||||||0.3708|||||||Chi-squared|||Parameter: The difference in the incidence of domicile country (Croatia) as a country of birth among patients from different groups.||||0.3708
71041924|NCT02780167|141593217|OTHER||Estimate difference|21.5|STANDARD_ERROR_OF_MEAN|6.25||0.0184|TWO_SIDED|95.0|5.5|37.6|||Emax model|Emax model with non-responder imputation (NRI)|Test group: PF-04965842 100 mg QD, Reference group: Placebo.|||37.6|5.5|0.0184
71041925|NCT02780167|141593217|OTHER||Mean Difference (Final Values)|38.2|STANDARD_ERROR_OF_MEAN|7.18||0.0032|TWO_SIDED|95.0|19.7|56.6|||Emax model|Emax model with non-responder imputation (NRI)|Test group: PF-04965842 200 mg QD, Reference group: Placebo.|||56.6|19.7|0.0032
71041926|NCT02780167|141593218|OTHER||LS mean difference|4.08|STANDARD_ERROR_OF_MEAN|9.667||0.6731|TWO_SIDED|90.0|-11.88|20.05|||Mixed Models Analysis|Mixed-effects model repeated measures (MMRM) with observed cases (OC)|Test group: PF-04965842 10 mg QD, Reference group: Placebo.|||20.05|-11.88|0.6731
71100503|NCT02732145|141709673|EQUIVALENCE|Question: Is there a difference in the incidence of patients educated equally or less than 12 years among different groups?||||||0.018|||||||Chi-squared|||Parameter: The difference in the incidence of patients educated equally or less than 12 years among different groups.||||0.0180
71100504|NCT02732145|141709673|EQUIVALENCE|Question: Is there a difference in marital status among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of marital status among patients from different groups.||||0.0000
71100505|NCT02732145|141709673|EQUIVALENCE|Question: Is there a difference in the nulliparity among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the nulliparity among patients from different groups.||||0.0000
71041927|NCT02780167|141593218|OTHER||LS mean difference|-5.52|STANDARD_ERROR_OF_MEAN|9.474||0.561|TWO_SIDED|90.0|-21.16|10.13|||Mixed Models Analysis|MMRM with OC|Test group: PF-04965842 30 mg QD, Reference group: Placebo.|||10.13|-21.16|0.5610
71041928|NCT02780167|141593218|OTHER||LS mean difference|-23.82|STANDARD_ERROR_OF_MEAN|9.043||0.0091|TWO_SIDED|90.0|-38.76|-8.88|||Mixed Models Analysis|MMRM with OC|Test group: PF-04965842 100 mg QD, Reference group: Placebo.|||-8.88|-38.76|0.0091
71100506|NCT02732145|141709673|EQUIVALENCE|Question: Is there a difference in the multiparity among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the multiparity among patients from different groups.||||0.0000
71100507|NCT02732145|141709673|EQUIVALENCE|Question: Is there a difference in the number of abortions among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the number of abortions among patients from different groups.||||0.0000
70999814|NCT00608881|141506714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09|||||TWO_SIDED|95.0|-1.4|1.58||||||||1.58|-1.40|
70999815|NCT00608881|141506715|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.44|||||TWO_SIDED|95.0|-6.68|3.79||||||||3.79|-6.68|
70999816|NCT00608881|141506716|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.12|||||TWO_SIDED|95.0|-4.4|2.16||||||||2.16|-4.40|
70999817|NCT00608881|141506717|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04|||||TWO_SIDED|95.0|-1.48|1.39||||||||1.39|-1.48|
70999818|NCT00608881|141506718|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.77|||||TWO_SIDED|95.0|-4.78|3.23||||||||3.23|-4.78|
70923953|NCT03978871|141339905|SUPERIORITY|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative immerse \> neutral immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005. The WFU PickAtlas via xjview was used to determine anatomical localization for surviving clusters.||||||1.86e-05||||||Reported result for cluster localized in the Middle Frontal Gyrus (Right). FWE-corrected p-value is reported. pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 278 voxels.|t-test, 2 sided|||||||.0000186
70999819|NCT00608881|141506719|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41|||||TWO_SIDED|95.0|-1.32|2.14||||||||2.14|-1.32|
70999820|NCT00608881|141506720|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-2.71|1.51||||||||1.51|-2.71|
70999821|NCT00608881|141506721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|||||TWO_SIDED|95.0|-2.28|2.87||||||||2.87|-2.28|
71041929|NCT02780167|141593218|OTHER||LS mean difference|-47.35|STANDARD_ERROR_OF_MEAN|9.008|<|0.0001|TWO_SIDED|90.0|-62.23|-32.47|||Mixed Models Analysis|MMRM with OC|Test group: PF-04965842 200 mg QD, Reference group: Placebo.|||-32.47|-62.23|<0.0001
71041930|NCT03180801|141593242|OTHER|||||||0.03|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower MMID rate than placebo.||||0.03
71041931|NCT03180801|141593242|OTHER|||||||0.07|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower MMID rate than placebo.||||0.07
71041932|NCT03180801|141593243|OTHER|One sided Fisher's exact test is used to test if TEAE rates of vaccine group is higher than the placebo group.||||||0.647|||||||Fisher Exact|||One sided Fisher's exact test is used to test if the TEAE rates pre-inoculation recorded for the treatment group are higher than for placebo.||||0.647
71041933|NCT03180801|141593243|OTHER|||||||1|||||||Fisher Exact|||One-sided Fisher's exact test is used to test if TEAE rate of vaccine group recorded pre-inoculation is higher than placebo.||||1.00
70999822|NCT00608881|141506722|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.88|||||TWO_SIDED|95.0|0.31|7.44||||||||7.44|0.31|
70999823|NCT00608881|141506723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.04|||||TWO_SIDED|95.0|-1.1|3.18||||||||3.18|-1.10|
70999824|NCT00608881|141506724|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.81|1.2||||||||1.20|0.81|
70999825|NCT00608881|141506725|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.75|1.15||||||||1.15|0.75|
70999826|NCT01150760|141506818|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.0007|||||||Chi-squared|||||||0.0007
70999827|NCT01150760|141506819|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.9|||<|0.0001|||||||Chi-squared|||||||< 0.0001
70999828|NCT01150760|141506820|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.6||||0.0001|||||||Chi-squared|||||||0.0001
70999829|NCT01150760|141506821|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.1022|||||||Chi-squared|||||||0.1022
70999830|NCT01150760|141506822|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2|||<|0.0001|||||||Chi-squared|||||||< 0.0001
70999831|NCT01150760|141506823|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
70999832|NCT01150760|141506824|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3||||0.0012|||||||Chi-squared|||||||0.0012
70999833|NCT01150760|141506825|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.003|||||||Chi-squared|||||||0.0030
70999834|NCT01150760|141506826|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.7637|||||||Chi-squared|||||||0.7637
70999835|NCT01150760|141506827|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.0402|||||||Chi-squared|||||||0.0402
70999836|NCT01150760|141506828|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.0755|||||||Chi-squared|||||||0.0755
70999837|NCT01150760|141506829|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9||||0.0532|||||||Chi-squared|||||||0.0532
70999838|NCT01150760|141506830|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||< 0.0001
70999839|NCT01150760|141506831|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
70999840|NCT03238352|141506834|OTHER||Difference of Least Square mean|-1.22|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.657|-0.782|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Test Product versus Negative Control at Week 8 is a primary endpoint comparison.||-0.782|-1.657|<0.0001
70999841|NCT03238352|141506834|OTHER||Difference of Least Square mean|-1.28|STANDARD_ERROR_OF_MEAN|0.213|<|0.0001|TWO_SIDED|95.0|-1.705|-0.858|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||-0.858|-1.705|<.0001
71041934|NCT03180801|141593243|OTHER|||||||0.024|||||||Fisher Exact|||One sided Fisher's exact test is used to test if TEAE rate of vaccine group post-inoculation is higher than the placebo group.||||0.0240
71041935|NCT03180801|141593243|OTHER|||||||0.186|||||||Fisher Exact|||One sided Fisher's exact test is used to test if TEAE rate of vaccine group post-inoculation is higher than the placebo group.||||0.186
71041936|NCT03180801|141593245|OTHER|||||||0.465|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects experiencing at least one symptom||||0.465
71041937|NCT03180801|141593245|OTHER|||||||0.074|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects experiencing at least one symptom||||0.074
71041938|NCT03180801|141593245|OTHER|||||||0.024|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects experiencing at least two symptoms||||0.024
70923954|NCT03978871|141339905|SUPERIORITY|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative immerse \> neutral immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005. The WFU PickAtlas via xjview was used to determine anatomical localization for surviving clusters.||||||0||||||Reported result for cluster localized in the Middle Frontal Gyrus (Left). FWE-corrected p-value is reported. pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 278 voxels.|t-test, 2 sided|||||||.000000000
70923955|NCT03978871|141339905|SUPERIORITY|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative immerse \> neutral immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005. The WFU PickAtlas via xjview was used to determine anatomical localization for surviving clusters.||||||1.61e-05||||||Reported result for cluster localized in the Posterior Cingulate/Cingulate. FWE-corrected p-value is reported. pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 278 voxels.|t-test, 2 sided|||||||.0000161
70923956|NCT03978871|141339905|OTHER|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative reframe \> negative immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005.|||||>|0.001||||||pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 298 voxels.|t-test, 2 sided|||||||>.001
70999842|NCT03238352|141506834|OTHER||Difference of Least Square mean|-1.25|STANDARD_ERROR_OF_MEAN|0.176|<|0.0001|TWO_SIDED|95.0|-1.6|-0.901|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Test Product versus Combined Control (Placebo and Negative Control) group was obtained by using estimates statement in the ANCOVA model.||-0.901|-1.600|<0.0001
70999843|NCT03238352|141506835|OTHER||Diference of Least Square mean|37.46|STANDARD_ERROR_OF_MEAN|7.306|<|0.0004|TWO_SIDED|95.0|22.916|51.995||P-value from Van Elteren test|ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is the first named treatment minus second named treatment such that a positive difference favors the first named treatment.|||51.995|22.916|<0.0004
70999844|NCT03238352|141506835|OTHER||Diference of Least Square mean|49.88|STANDARD_ERROR_OF_MEAN|7.079|<|0.0001|TWO_SIDED|95.0|35.791|63.966||P-value from Van Elteren test|ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is the first named treatment minus second named treatment such that a positive difference favors the first named treatment.|||63.966|35.791|<.0001
70999845|NCT03238352|141506835|OTHER||Diference of Least Square mean|43.67|STANDARD_ERROR_OF_MEAN|5.862|<|0.0001|TWO_SIDED|95.0|32.001|55.334||P-value from Van Elteren test.|ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is the first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Test Product versus Combined Control (Placebo and Negative Control) group is obtained by using estimates statement in the ANCOVA model||55.334|32.001|<.0001
70999846|NCT01975675|141506860|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Treatment-naive noncirrhotic participants in the LDV/SOF (treatment naive) group were compared to the adjusted historical SVR null rate of 63% using a two-sided exact one-sample binomial test.|Binomial test|||||||< 0.001
70999847|NCT01975675|141506860|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Treatment-naive noncirrhotic participants in the LDV/SOF+RBV (treatment naive) group were compared to the adjusted historical SVR null rate of 63% using a two-sided exact one-sample binomial test.|Binomial test|||||||< 0.001
70999848|NCT01975675|141506861|SUPERIORITY_OR_OTHER||Difference in proportions|-3.6|||||TWO_SIDED|95.0|-10.2|1.0|||||The 95% confidence interval (CI) on the difference in proportions is based on the exact method (standardized statistic and inverting two 1-sided tests).|||1.0|-10.2|
70999849|NCT01975675|141506861|SUPERIORITY_OR_OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-4.2|4.2|||||The 95% CI on the difference in proportions is based on the exact method (standardized statistic and inverting two 1-sided tests).|||4.2|-4.2|
70999850|NCT00871572|141506887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94||||0.0296|TWO_SIDED|90.0|-1.64|-0.23|||Mixed Models Analysis|||||-0.23|-1.64|0.0296
70999851|NCT00871572|141506887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76||||0.0418|TWO_SIDED|90.0|-1.37|-0.15|||Mixed Models Analysis|||||-0.15|-1.37|0.0418
70999852|NCT00871572|141506887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76||||0.0514|TWO_SIDED|90.0|-1.41|-0.12|||Mixed Models Analysis|||||-0.12|-1.41|0.0514
70923957|NCT03978871|141339906|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.56|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (baseline and follow-up) on depression levels from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.560
70923958|NCT03978871|141339907|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.327|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (baseline and follow-up) on depression levels from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.327
70999853|NCT00871572|141506888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.62||||0.2565|TWO_SIDED|95.0|-4.46|1.21|||Mixed Models Analysis|||||1.21|-4.46|0.2565
70999854|NCT00871572|141506888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.86||||0.1245|TWO_SIDED|95.0|-4.25|0.53|||Mixed Models Analysis|||||0.53|-4.25|0.1245
70999855|NCT00871572|141506888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.41||||0.0594|TWO_SIDED|95.0|-4.92|0.1|||Mixed Models Analysis|||||0.10|-4.92|0.0594
70999856|NCT00871572|141506889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-124.56||||0.4978|TWO_SIDED|95.0|-490.02|240.9|||ANCOVA|||||240.90|-490.02|0.4978
70999857|NCT00871572|141506889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-338.64||||0.0372|TWO_SIDED|95.0|-656.55|-20.72|||ANCOVA|||||-20.72|-656.55|0.0372
70999858|NCT00871572|141506889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-466.83||||0.0068|TWO_SIDED|95.0|-799.48|-134.18|||ANCOVA|||||-134.18|-799.48|0.0068
70999859|NCT00871572|141506890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.814|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||||0.7|-0.5|0.814
70999860|NCT00871572|141506890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.681|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||||0.7|-0.4|0.681
70999861|NCT00871572|141506890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.715|TWO_SIDED|95.0|-0.7|0.5|||ANCOVA|||||0.5|-0.7|0.715
70999862|NCT00871572|141506893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.56||||0.0248|TWO_SIDED|95.0|-44.03|-3.09||P-value is for Pre-Morning Meal (fasting).|Mixed Models Analysis|||||-3.09|-44.03|0.0248
70999863|NCT00871572|141506893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.28||||0.0002|TWO_SIDED|95.0|-53.08|-17.48||P-value is for Pre-Morning Meal (fasting).|Mixed Models Analysis|||||-17.48|-53.08|0.0002
70999864|NCT00871572|141506893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.32|||<|0.0001|TWO_SIDED|95.0|-58.12|-20.53||P-value is for Pre-Morning Meal (fasting).|Mixed Models Analysis|||||-20.53|-58.12|<0.0001
71041939|NCT03180801|141593245|OTHER|||||||0.23|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects experiencing at least two symptoms.||||0.230
70999865|NCT00871572|141506893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.42||||0.6513|TWO_SIDED|95.0|-34.66|21.82||P-value is for 2 Hours After Morning Meal.|Mixed Models Analysis|||||21.82|-34.66|0.6513
70999866|NCT00871572|141506893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2||||0.5045|TWO_SIDED|95.0|-32.61|16.21||P-value is for 2 Hours After Morning Meal.|Mixed Models Analysis|||||16.21|-32.61|0.5045
70999867|NCT00871572|141506893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.2||||0.5774|TWO_SIDED|95.0|-32.9|18.49||P-value is for 2 Hours After Morning Meal.|Mixed Models Analysis|||||18.49|-32.90|0.5774
70999868|NCT00871572|141506893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.81||||0.0045|TWO_SIDED|95.0|-60.1|-11.53||P-value is for Pre-Mid-Day Meal.|Mixed Models Analysis|||||-11.53|-60.10|0.0045
70999869|NCT00871572|141506893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.15||||0.0024|TWO_SIDED|95.0|-54.1|-12.21||P-value is for Pre-Mid-Day Meal.|Mixed Models Analysis|||||-12.21|-54.10|0.0024
70999870|NCT00871572|141506893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-37.87||||0.0011|TWO_SIDED|95.0|-59.98|-15.75||P-value is for Pre-Mid-Day Meal.|Mixed Models Analysis|||||-15.75|-59.98|0.0011
70999871|NCT00871572|141506893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.48||||0.0389|TWO_SIDED|95.0|-55.47|-1.49||P-value is for 2 Hours After Mid-Day Meal.|Mixed Models Analysis|||||-1.49|-55.47|0.0389
70999872|NCT00871572|141506893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.65||||0.1896|TWO_SIDED|95.0|-39.24|7.94||P-value is for 2 Hours After Mid-Day Meal.|Mixed Models Analysis|||||7.94|-39.24|0.1896
70999873|NCT00871572|141506893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.56||||0.0729|TWO_SIDED|95.0|-47.28|2.16||P-value is for 2 Hours After Mid-Day Meal.|Mixed Models Analysis|||||2.16|-47.28|0.0729
70999874|NCT00871572|141506893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.78||||0.0041|TWO_SIDED|95.0|-74.79|-14.77||P-value is for Pre Evening Meal.|Mixed Models Analysis|||||-14.77|-74.79|0.0041
70999875|NCT00871572|141506893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-54.45|||<|0.0001|TWO_SIDED|95.0|-80.42|-28.48||P-value is for Pre Evening Meal.|Mixed Models Analysis|||||-28.48|-80.42|<0.0001
70999876|NCT00871572|141506893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.19||||0.0013|TWO_SIDED|95.0|-73.57|-18.81||P-value is for Pre Evening Meal.|Mixed Models Analysis|||||-18.81|-73.57|0.0013
70999877|NCT00871572|141506893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.82||||0.0118|TWO_SIDED|95.0|-70.51|-9.13||P-value is for 2 Hours After Evening Meal.|Mixed Models Analysis|||||-9.13|-70.51|0.0118
70999878|NCT00871572|141506893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.8||||0.0016|TWO_SIDED|95.0|-70.42|-17.18||P-value is for 2 Hours After Evening Meal.|Mixed Models Analysis|||||-17.18|-70.42|0.0016
71041940|NCT03180801|141593245|OTHER|||||||0.09|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects with detectable virus shedding||||0.09
71041941|NCT03180801|141593245|OTHER|||||||0.22|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects with detectable virus shedding||||0.22
71041942|NCT03180801|141593245|OTHER|||||||0.23|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects asymptomatic with detectable virus shedding||||0.23
71041943|NCT03180801|141593245|OTHER|||||||0.12|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects asymptomatic with detectable virus shedding||||0.12
71041944|NCT03180801|141593246|OTHER|||||||0.0501|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has shorter shedding duration than placebo.||||0.0501
71041945|NCT03180801|141593246|OTHER|||||||0.3139|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has shorter shedding duration than placebo.||||0.3139
71041946|NCT03180801|141593247|OTHER|||||||0.102|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has smaller shedding AUC than placebo.||||0.102
71041947|NCT03180801|141593247|OTHER|||||||0.481|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has a smaller shedding AUC than placebo.||||0.481
70999879|NCT00871572|141506893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.56||||0.0065|TWO_SIDED|95.0|-67.63|-11.48||P-value is for 2 Hours After Evening Meal.|Mixed Models Analysis|||||-11.48|-67.63|0.0065
70999880|NCT00871572|141506893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.88||||0.0154|TWO_SIDED|95.0|-66.43|-7.33||P-value is for Bedtime.|Mixed Models Analysis|||||-7.33|-66.43|0.0154
71041948|NCT03180801|141593248|OTHER|||||||0.128|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has lower peak viral shedding than placebo.||||0.128
71041949|NCT03180801|141593248|OTHER|||||||0.601|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has lower peak viral shedding than placebo.||||0.601
71041950|NCT03180801|141593249|OTHER|||||||0.142|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has shorter duration of symptoms than placebo.||||0.142
71100508|NCT02732145|141709673|EQUIVALENCE|Question: Is there a difference in the using of contraception among patients from different groups?||||||0.1323|||||||Chi-squared|||Parameter: The difference in the using of contraception among patients from different groups.||||0.1323
71100509|NCT02732145|141709674|EQUIVALENCE|Question: Is there a difference in the incidence of symptoms of the dull pain of the vulva among patients with vulvar discomfort?||||||0.3158|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the dull pain of the vulva (burning, stinging, soreness, irritation, itching, inflammation, aching) among patients with vulvar discomfort.||||0.3158
71100510|NCT02732145|141709674|EQUIVALENCE|Question: Is there a difference in the incidence of symptoms of the sharp pain of the vulva among patients with vulvar discomfort?||||||0.0007|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the sharp pain in the vulva (stabbing, sticking, knife-like pain, paper-cuts pain) among patients with vulvar discomfort.||||0.0007
70999881|NCT00871572|141506893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.5||||0.0006|TWO_SIDED|95.0|-71.93|-21.07||P-value is for Bedtime.|Mixed Models Analysis|||||-21.07|-71.93|0.0006
70999882|NCT00871572|141506893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.07||||0.0029|TWO_SIDED|95.0|-69.13|-15.01||P-value is for Bedtime.|Mixed Models Analysis|||||-15.01|-69.13|0.0029
71041951|NCT03180801|141593249|OTHER|||||||0.147|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has shorter duration of symptoms than placebo.||||0.147
71041952|NCT03180801|141593250|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has fewer average number of symptoms than placebo.||||0.080
70999883|NCT00871572|141506894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.62||||0.3815|TWO_SIDED|95.0|-32.44|83.68|||Mixed Models Analysis|||||83.68|-32.44|0.3815
70999884|NCT00871572|141506894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4||||0.8315|TWO_SIDED|95.0|-45.12|55.93|||Mixed Models Analysis|||||55.93|-45.12|0.8315
70999885|NCT00871572|141506894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.25||||0.3658|TWO_SIDED|95.0|-28.93|77.44|||Mixed Models Analysis|||||77.44|-28.93|0.3658
70999886|NCT00871572|141506895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|55.06||||0.2131|TWO_SIDED|95.0|-32.24|142.37|||Mixed Models Analysis|||||142.37|-32.24|0.2131
71041953|NCT03180801|141593250|OTHER|||||||0.271|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has fewer average number of symptoms than placebo.||||0.271
71041954|NCT03180801|141593251|OTHER|||||||0.099|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has fewer peak symptoms than placebo.||||0.099
71041955|NCT03180801|141593251|OTHER|||||||0.178|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has fewer peak symptoms than placebo.||||0.178
71041956|NCT03180801|141593252|OTHER|||||||0.064|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has lower FLU-PRO scores than placebo.||||0.064
71041957|NCT03180801|141593252|OTHER|||||||0.201|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has lower FLU-PRO scores than placebo.||||0.201
71041958|NCT03180801|141593253|OTHER||||||<|0.001|||||||t-test, 2 sided|||comparison on day -2||||<0.001
71041959|NCT03180801|141593253|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparion on day -2||||<0.001
71041960|NCT03180801|141593253|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison on day 35||||<0.001
71041961|NCT03180801|141593253|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison on day 35||||<0.001
71041962|NCT03180801|141593253|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison on day 63||||<0.001
71041963|NCT03180801|141593253|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison on day 63||||<0.001
71041964|NCT03756883|141593254|EQUIVALENCE|The 90% Confidence Interval for the test-to-reference ratio was calculated using a procedure similar to Fieller's method.|Test-to-Reference Ratio|101.8|||||TWO_SIDED|90.0|92.68|111.94||||||||111.94|92.68|
71041965|NCT03756883|141593255|EQUIVALENCE|The 90% confidence interval for the test-to-reference ratio was calculated using a procedure similar to Fieller's method.|Test-to-Reference Ratio|98.09|||||TWO_SIDED|90.0|87.1|110.61||||||||110.61|87.10|
71100511|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of the dull pain versus the sharp pain of the vulva in the patients with vulvar dermatosis?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the dull pain versus the sharp pain of the vulva in patients with vulvar dermatosis.||||0.0000
70923959|NCT03978871|141339908|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.439|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (baseline and follow-up) on anxiety levels from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.439
70923960|NCT03978871|141339908|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.545|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (baseline and follow-up) on anxiety levels from time 1 to time 2. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.545
70999887|NCT00871572|141506895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|89.68||||0.022|TWO_SIDED|95.0|13.27|166.1|||Mixed Models Analysis|||||166.10|13.27|0.0220
71041966|NCT03756883|141593256|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Superiority of the test product over the placebo.||||<0.0001
70923961|NCT03978871|141339909|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.74|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (baseline and follow-up) on anxiety levels from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.740
70923962|NCT00220740|141339946|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||The primary efficacy endpoint was the comparison of the Responder rates in the ITT population. Treatment group differences were tested by a Chi-square test. Subjects who did not complete the 24 week Efficacy Period and entered Rescue treatment with the alternative treatment were counted as Nonresponders.||||<0.001
70999888|NCT00871572|141506895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|107.26||||0.0101|TWO_SIDED|95.0|26.29|188.22|||Mixed Models Analysis|||||188.22|26.29|0.0101
70999889|NCT00871572|141506896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.87||||0.1596|TWO_SIDED|95.0|-0.75|4.49|||Mixed Models Analysis|||||4.49|-0.75|0.1596
70999890|NCT00871572|141506896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03||||0.0791|TWO_SIDED|95.0|-0.24|4.31|||Mixed Models Analysis|||||4.31|-0.24|0.0791
70999891|NCT00871572|141506896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.71||||0.1564|TWO_SIDED|95.0|-0.67|4.1|||Mixed Models Analysis|||||4.10|-0.67|0.1564
70999892|NCT00871572|141506897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8018.51||||0.45|TWO_SIDED|95.0|-13104.14|29141.16|||ANCOVA|||||29141.16|-13104.14|0.4500
70999893|NCT00871572|141506897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5174.85||||0.5739|TWO_SIDED|95.0|-13158.65|23508.35|||ANCOVA|||||23508.35|-13158.65|0.5739
70923963|NCT00220740|141339947|SUPERIORITY_OR_OTHER|||||||0.542|TWO_SIDED||||||ANCOVA|||||||0.542
70923964|NCT00220740|141339948|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Dominant hand||||<0.001
70999894|NCT00871572|141506897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18153.92||||0.0653|TWO_SIDED|95.0|-1188.23|37496.06|||ANCOVA|||||37496.06|-1188.23|0.0653
70999895|NCT00871572|141506898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18094.32||||0.6209|TWO_SIDED|95.0|-54734.08|90922.71|||ANCOVA|||||90922.71|-54734.08|0.6209
70999896|NCT00871572|141506898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5783.59||||0.8581|TWO_SIDED|95.0|-58650.71|70217.89|||ANCOVA|||||70217.89|-58650.71|0.8581
70999897|NCT00871572|141506898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36218.98||||0.285|TWO_SIDED|95.0|-30955.5|103393.46|||ANCOVA|||||103393.46|-30955.50|0.2850
71041967|NCT03756883|141593256|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Superiority of Reference to placebo.||||<0.0001
70999898|NCT00871572|141506899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.584|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||||0.4|-0.7|0.584
70999899|NCT00871572|141506899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.426|TWO_SIDED|95.0|-0.7|0.3|||ANCOVA|||||0.3|-0.7|0.426
70999900|NCT00871572|141506899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.657|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||||0.4|-0.6|0.657
70999901|NCT00871572|141506900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.365|TWO_SIDED|95.0|-0.1|0.4|||ANCOVA|||||0.4|-0.1|0.365
70999902|NCT00871572|141506900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.191|TWO_SIDED|95.0|-0.1|0.4|||ANCOVA|||||0.4|-0.1|0.191
71041968|NCT03756883|141593257|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Superiority of test over placebo.||||<0.0001
71041969|NCT03756883|141593257|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Superiority of reference to placebo.||||<0.0001
71041970|NCT02445287|141593258|SUPERIORITY_OR_OTHER|||||||0.92||||||Level of significance (alpha) = 0.05|t-test, 2 sided|||||||0.920
71041971|NCT02445287|141593259|SUPERIORITY_OR_OTHER|||||||0||||||Level of significance (alpha) = 0.05|t-test, 1 sided|||||||0.000
71041972|NCT02445287|141593260|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence interval = (-0.25, 0.25)||||||0||||||level of significance (alpha) = 0.05|Equivalence test|||||||0.000
71041973|NCT02445287|141593261|SUPERIORITY_OR_OTHER|||||||0.012||||||level of significance (alpha) = 0.05|t-test, 1 sided|||||||0.012
70923965|NCT00220740|141339948|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||ANCOVA|||Non-dominant hand||||0.005
70923966|NCT00812461|141340009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|0.68||0.012|TWO_SIDED|95.0|-3.07|-0.38|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 229 participants in the placebo group and 212 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. The null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-6); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."||-0.38|-3.07|0.012
71041974|NCT03235479|141593262|SUPERIORITY||Risk Difference (RD)|4.9||||0.0298|TWO_SIDED|95.0|0.5|9.3|||Cochran-Mantel-Haenszel|||||9.3|0.5|0.0298
71041975|NCT03235479|141593263|SUPERIORITY||Risk Difference (RD)|8.9||||0.0016|TWO_SIDED|95.0|3.4|14.4|||Cochran-Mantel-Haenszel|||||14.4|3.4|0.0016
71041976|NCT03235479|141593264|SUPERIORITY||Risk Difference (RD)|10.2||||0.0005|TWO_SIDED|95.0|4.4|15.9|||Cochran-Mantel-Haenszel|||||15.9|4.4|0.0005
71041977|NCT03235479|141593265|SUPERIORITY||Risk Difference (RD)|7.7||||0.0299|TWO_SIDED|95.0|0.8|14.6|||Cochran-Mantel-Haenszel|||||14.6|0.8|0.0299
70999903|NCT00871572|141506900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.297|TWO_SIDED|95.0|-0.1|0.4|||ANCOVA|||||0.4|-0.1|0.297
70999904|NCT00871572|141506901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.523|TWO_SIDED|95.0|-0.8|0.4|||ANCOVA|||||0.4|-0.8|0.523
70999905|NCT00871572|141506901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.476|TWO_SIDED|95.0|-0.7|0.3|||ANCOVA|||||0.3|-0.7|0.476
70999906|NCT00871572|141506901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.634|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||||0.4|-0.7|0.634
70999907|NCT00871572|141506902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.919|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|||||0.6|-0.6|0.919
70999908|NCT00871572|141506902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.864|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||||0.6|-0.5|0.864
70999909|NCT00871572|141506902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.726|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||||0.7|-0.5|0.726
70999910|NCT00735670|141506903|SUPERIORITY_OR_OTHER|||||||0.445|||||||Fisher Exact|||||||0.445
70999911|NCT00735670|141506904|SUPERIORITY_OR_OTHER||REML|-0.31||||0.725|TWO_SIDED|95.0|-0.48|-0.15||Comparison of venlafaxine vs. placebo on change of PHQ-9 over time controlling for baseline PHQ-9 score.|Mixed Models Analysis|||A linear mixed model (LMM) analysis was used and included a random intercept effect based on lowest Akaike's Information Criterion values when we compared three random coefficient models (intercept, slope and intercept and slope). To examine whether allocation group influenced the effect of time and baseline PHQ-9 sore on the trajectory of PHQ-9 scores, we included two interaction terms (time by allocation group and baseline PHQ-9 score by allocation group).||-0.15|-0.48|0.725
70999912|NCT03920865|141506912|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|0.802|||||TWO_SIDED|90.0|0.627|1.03||||||||1.03|0.627|
71041978|NCT03235479|141593266|SUPERIORITY||Risk Difference (RD)|10.3||||0.0006|TWO_SIDED|95.0|4.4|16.2|||Cochran-Mantel-Haenszel|||||16.2|4.4|0.0006
71041979|NCT03235479|141593267|SUPERIORITY||Risk Difference (RD)|5.2||||0.1815|TWO_SIDED|95.0|-2.4|12.9||P-value ≥ 0.05; therefore, all secondary outcome measures listed after this outcome measure in the hierarchy were not tested.|Cochran-Mantel-Haenszel|||||12.9|-2.4|0.1815
71041980|NCT03110380|141593282|NON_INFERIORITY|A sample size of 260 participants per treatment group would provide at least 90% power to detect a non-inferiority margin of 4% in difference in percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 between the two treatment groups. This was based on the assumptions that both treatment groups have 2% of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 (based on Gilead Genvoya and Stribild studies) and that the significance level of the test is at a one-sided 0.025 level.|Difference in Percentages|-0.7|||||TWO_SIDED|95.001|-2.8|1.0|||||The differences in percentages of participants between treatment groups and their 95.001% confidence intervals (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The null hypothesis was that the B/F/TAF group is at least 4% higher than the DTG + F/TAF group with respect to the percentage of participants with HIV-1 RNA ≥ 50 copies/mL as determined by the US FDA-defined snapshot algorithm at Week 48; the alternative hypothesis was that the B/F/TAF group is less than 4% higher than the DTG + F/TAF group with respect to the percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48.||1.0|-2.8|
71041981|NCT03110380|141593282|SUPERIORITY|||||||0.37|||||||Fisher Exact|||||||0.37
71100512|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of the dull pain versus the sharp pain of the vulva in the patients with vulvodynia?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the dull pain versus the sharp pain of the vulva in patients with vulvodynia.||||0.0000
71100513|NCT02732145|141709674|EQUIVALENCE|Question: Is there a difference in the incidence of vulvar burning among patients with vulvar discomfort?||||||0.0147|||||||Chi-squared|||Parameter: The difference in the incidence of vulvar burning among patients with vulvar discomfort.||||0.0147
70999913|NCT03920865|141506912|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|0.842|||||TWO_SIDED|90.0|0.588|1.21||||||||1.21|0.588|
70999914|NCT03920865|141506914|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|0.95|||||TWO_SIDED|90.0|0.695|1.3||||||||1.30|0.695|
70999915|NCT03920865|141506914|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|0.953|||||TWO_SIDED|90.0|0.715|1.27||||||||1.27|0.715|
70999916|NCT03920865|141506915|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|1.08|||||TWO_SIDED|90.0|0.83|1.39||||||||1.39|0.830|
70999917|NCT03920865|141506915|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|0.947|||||TWO_SIDED|90.0|0.74|1.21||||||||1.21|0.740|
70999918|NCT03920865|141506917|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|1.2|||||TWO_SIDED|90.0|0.962|1.49||||||||1.49|0.962|
70999919|NCT03920865|141506917|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|0.991|||||TWO_SIDED|90.0|0.81|1.21||||||||1.21|0.810|
70999920|NCT00108953|141506935|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.6||||0.016||95.0|0.33|0.95|||Log Rank||Hazard ratio: nexavar+doxorubicin over placebo+doxorubicin|The comparison between the 2 groups is done using the log rank test stratified by tumor burden. The null hypothesis is: TTP is the same in both treatment groups.||0.95|0.33|0.016
70999921|NCT00108953|141506936|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.52||||0.007||95.0|0.37|0.74|||Log Rank||Hazard ratio: nexavar+doxorubicin over placebo+doxorubicin|The comparison between the 2 groups is done using the log rank test stratified by tumor burden. The null hypothesis is: TTP is the same in both treatment groups||0.74|0.37|0.007
70999922|NCT00108953|141506937|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.018||95.0|0.45|0.83|||Log Rank||Hazard ratio: nexavar+doxorubicin over placebo+doxorubicin|The comparison between the 2 groups is done using the log rank test stratified by tumor burden. The null hypothesis is: TTP is the same in both treatment groups||0.83|0.45|0.018
70999923|NCT00108953|141506939|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.038||95.0|0.4|1.05|||Log Rank||Hazard ratio: nexavar+doxorubicin over placebo+doxorubicin|The comparison between the 2 groups is done using the log rank test stratified by tumor burden. The null hypothesis is: TTP is the same in both treatment groups||1.05|0.40|0.038
70999924|NCT03803202|141506956|OTHER||Ratio of GMT|1.14|||||TWO_SIDED|95.0|0.7|1.85|||t-test, 2 sided|||Serotype 1, Day 1||1.85|0.70|
70999925|NCT03803202|141506956|OTHER||Ratio of GMT|1.17|||||TWO_SIDED|95.0|0.72|1.9|||t-test, 2 sided|||Serotype 1, Day 1||1.90|0.72|
70999926|NCT03803202|141506956|OTHER||Ratio of GMT|1.17|||||TWO_SIDED|95.0|0.74|1.87|||t-test, 2 sided|||Serotype 1, Day 1||1.87|0.74|
70923967|NCT00812461|141340010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.95|STANDARD_ERROR_OF_MEAN|2.89||0.088|TWO_SIDED|95.0|-10.63|0.73|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 229 participants in the placebo group and 212 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. The null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-6); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."||0.73|-10.63|0.088
71041982|NCT03110380|141593283|NON_INFERIORITY|It would be concluded that B/F/TAF is noninferior to DTG+F/TAF if the lower bound of the 2-sided 95.001% CI of the difference between treatment groups (B/F/TAF group -DTG+F/TAF group) in the percentage of participants with HIV-1 RNA \< 50 copies/mL is greater than -10%.|Difference in Percentages|2.2|||||TWO_SIDED|95.001|-2.3|6.8|||||The differences in percentages of participants between treatment groups and their 95.001% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|||6.8|-2.3|
71041983|NCT03110380|141593284|SUPERIORITY||Difference in LSM|-18.0||||0.23|TWO_SIDED|95.0|-46.0|11.0|||ANOVA|P-value, difference in least squares means (LSM), and its 95% CI were from ANOVA model with treatment group as a fixed effect in the model.||||11|-46|0.23
71041984|NCT03750695|141593305|OTHER||||||<|0.05|||||||Regression, Linear|||Repeated measures linear regression||||<0.05
71100514|NCT02732145|141709674|EQUIVALENCE|Question: Is there a difference in the incidence of vulvar stinging among patients with vulvar discomfort?||||||0.8456|||||||Chi-squared|||Parameter: The difference in the incidence of vulvar stinging among patients with vulvar discomfort.||||0.8456
71100515|NCT02732145|141709674|EQUIVALENCE|Question: Is there a difference in the incidence of vulvar soreness among patients with vulvar discomfort?||||||0.0076|||||||Chi-squared|||Parameter: The difference in the incidence of vulvar soreness among patients with vulvar discomfort.||||0.0076
71100516|NCT02732145|141709674|EQUIVALENCE|Question: Is there a difference in the incidence of irritation of the vulva among the patients with vulvar discomfort?||||||0.0423|||||||Chi-squared|||Parameter: The difference in the incidence of irritation of the vulva among patients with vulvar discomfort.||||0.0423
71100517|NCT02732145|141709674|EQUIVALENCE|Question: Is there a difference in the incidence of the knife-like pain in the vulva among the patients with vulvar discomfort?||||||0.0457|||||||Chi-squared|||Parameter: The difference in the incidence of the knife-like pain in the vulva among patients with vulvar discomfort.||||0.0457
71100518|NCT02732145|141709674|EQUIVALENCE|Question: Is there a difference in the incidence of the paper-cuts pain of the vulva among the patients with vulvar discomfort?||||||0.043|||||||Chi-squared|||Parameter: The difference in the incidence of the paper-cuts pain of the vulva among patients with vulvar discomfort.||||0.0430
70999927|NCT03803202|141506956|OTHER||Ratio of GMT|1.57|||||TWO_SIDED|95.0|0.68|3.63|||t-test, 2 sided|||Serotype 3, Day 1||3.63|0.68|
70999928|NCT03803202|141506956|OTHER||Ratio of GMT|2.04|||||TWO_SIDED|95.0|0.86|4.82|||t-test, 2 sided|||Serotype 3, Day 1||4.82|0.86|
70999929|NCT03803202|141506956|OTHER||Ratio of GMT|0.67|||||TWO_SIDED|95.0|0.31|1.46|||t-test, 2 sided|||Serotype 3, Day 1||1.46|0.31|
70999930|NCT03803202|141506956|OTHER||Ratio of GMT|1.11|||||TWO_SIDED|95.0|0.27|4.55|||t-test, 2 sided|||Serotype 4, Day 1||4.55|0.27|
70999931|NCT03803202|141506956|OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.19|2.61|||t-test, 2 sided|||Serotype 4, Day 1||2.61|0.19|
70999932|NCT03803202|141506956|OTHER||Ratio of GMT|1.83|||||TWO_SIDED|95.0|0.49|6.85|||t-test, 2 sided|||Serotype 4, Day 1||6.85|0.49|
70999933|NCT03803202|141506956|OTHER||Ratio of GMT|1.9|||||TWO_SIDED|95.0|0.76|4.73|||t-test, 2 sided|||Serotype 5, Day 1||4.73|0.76|
70999934|NCT03803202|141506956|OTHER||Ratio of GMT|1.22|||||TWO_SIDED|95.0|0.62|2.4|||t-test, 2 sided|||Serotype 5, Day 1||2.40|0.62|
70999935|NCT03803202|141506956|OTHER||Ratio of GMT|0.93|||||TWO_SIDED|95.0|0.52|1.65|||t-test, 2 sided|||Serotype 5, Day 1||1.65|0.52|
70999936|NCT03803202|141506956|OTHER||Ratio of GMT|0.84|||||TWO_SIDED|95.0|0.25|2.82|||t-test, 2 sided|||Serotype 6A, Day 1||2.82|0.25|
70999937|NCT03803202|141506956|OTHER||Ratio of GMT|0.73|||||TWO_SIDED|95.0|0.24|2.23|||t-test, 2 sided|||Serotype 6A, Day 1||2.23|0.24|
70999938|NCT03803202|141506956|OTHER||Ratio of GMT|1.03|||||TWO_SIDED|95.0|0.31|3.41|||t-test, 2 sided|||Serotype 6A, Day 1||3.41|0.31|
70999939|NCT03803202|141506956|OTHER||Ratio of GMT|1.19|||||TWO_SIDED|95.0|0.32|4.46|||t-test, 2 sided|||Serotype 6B,Day 1||4.46|0.32|
70999940|NCT03803202|141506956|OTHER||Ratio of GMT|1.3|||||TWO_SIDED|95.0|0.42|4.05|||t-test, 2 sided|||Serotype 6B, Day 1||4.05|0.42|
70999941|NCT03803202|141506956|OTHER||Ratio of GMT|0.71|||||TWO_SIDED|95.0|0.24|2.14|||t-test, 2 sided|||Serotype 6B, Day 1||2.14|0.24|
70999942|NCT03803202|141506956|OTHER||Ratio of GMT|0.76|||||TWO_SIDED|95.0|0.26|2.17|||t-test, 2 sided|||Serotype 7F, Day 1||2.17|0.26|
70999943|NCT03803202|141506956|OTHER||Ratio of GMT|0.32|||||TWO_SIDED|95.0|0.11|0.89|||t-test, 2 sided|||Serotype 7F, Day 1||0.89|0.11|
70999944|NCT03803202|141506956|OTHER||Ratio of GMT|0.31|||||TWO_SIDED|95.0|0.1|0.93|||t-test, 2 sided|||Serotype 7F, Day 1||0.93|0.10|
70999945|NCT03803202|141506956|OTHER||Ratio of GMT|1.92|||||TWO_SIDED|95.0|0.74|4.99|||t-test, 2 sided|||Serotype 9V, Day 1||4.99|0.74|
70999946|NCT03803202|141506956|OTHER||Ratio of GMT|0.48|||||TWO_SIDED|95.0|0.15|1.61|||t-test, 2 sided|||Serotype 9V, Day 1||1.61|0.15|
70999947|NCT03803202|141506956|OTHER||Ratio of GMT|0.62|||||TWO_SIDED|95.0|0.21|1.9|||t-test, 2 sided|||Serotype 9V, Day 1||1.90|0.21|
70999948|NCT03803202|141506956|OTHER||Ratio of GMT|4.2|||||TWO_SIDED|95.0|1.17|15.09|||t-test, 2 sided|||Serotype 14, Day 1||15.09|1.17|
70999949|NCT03803202|141506956|OTHER||Ratio of GMT|1.91|||||TWO_SIDED|95.0|0.52|7.07|||t-test, 2 sided|||Serotype 14, Day 1||7.07|0.52|
70999950|NCT03803202|141506956|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.23|4.25|||t-test, 2 sided|||Serotype 14, Day 1||4.25|0.23|
70999951|NCT03803202|141506956|OTHER||Ratio of GMT|0.74|||||TWO_SIDED|95.0|0.21|2.62|||t-test, 2 sided|||Serotype 18C, Day 1||2.62|0.21|
70999952|NCT03803202|141506956|OTHER||Ratio of GMT|1.19|||||TWO_SIDED|95.0|0.37|3.77|||t-test, 2 sided|||Serotype 18C, Day 1||3.77|0.37|
70999953|NCT03803202|141506956|OTHER||Ratio of GMT|1.22|||||TWO_SIDED|95.0|0.38|3.94|||t-test, 2 sided|||Serotype 18C, Day 1||3.94|0.38|
70999954|NCT03803202|141506956|OTHER||Ratio of GMT|1.11|||||TWO_SIDED|95.0|0.51|2.45|||t-test, 2 sided|||Serotype 19A, Day 1||2.45|0.51|
70999955|NCT03803202|141506956|OTHER||Ratio of GMT|0.71|||||TWO_SIDED|95.0|0.31|1.63|||t-test, 2 sided|||Serotype 19A, Day 1||1.63|0.31|
70999956|NCT03803202|141506956|OTHER||Ratio of GMT|0.74|||||TWO_SIDED|95.0|0.36|1.53|||t-test, 2 sided|||Serotype 19A, Day 1||1.53|0.36|
70999957|NCT03803202|141506956|OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.24|2.08|||t-test, 2 sided|||Serotype 19F, Day 1||2.08|0.24|
70999958|NCT03803202|141506956|OTHER||Ratio of GMT|1.24|||||TWO_SIDED|95.0|0.44|3.5|||t-test, 2 sided|||Serotype 19F, Day 1||3.50|0.44|
70999959|NCT03803202|141506956|OTHER||Ratio of GMT|1.45|||||TWO_SIDED|95.0|0.58|3.61|||t-test, 2 sided|||Serotype 19F, Day 1||3.61|0.58|
70999960|NCT03803202|141506956|OTHER||Ratio of GMT|2.22|||||TWO_SIDED|95.0|0.46|10.69|||t-test, 2 sided|||Serotype 23F, Day 1||10.69|0.46|
70999961|NCT03803202|141506956|OTHER||Ratio of GMT|1.36|||||TWO_SIDED|95.0|0.31|5.99|||t-test, 2 sided|||Serotype 23F, Day 1||5.99|0.31|
71041985|NCT04480307|141593317|SUPERIORITY||LS Mean Difference|-0.031||||0.5084|TWO_SIDED|95.0|-0.124|0.063|||ANCOVA|||||0.063|-0.124|0.5084
71041986|NCT04480307|141593317|SUPERIORITY||Difference of change from Baseline|-0.021|||||TWO_SIDED|95.0|-0.121|0.057|||Bayesian|Difference of change from baseline a posteriori||Bayesian analysis is done using a non-informative prior on the mean observed difference.||0.057|-0.121|
71100519|NCT02732145|141709674|EQUIVALENCE|Question: Is there a difference in the incidence of the stabbing of the vulva among the patients with vulvar discomfort?||||||0.0134|||||||Chi-squared|||Parameter: The difference in the incidence of the stabbing of the vulva among patients with vulvar discomfort.||||0.0134
71100520|NCT02732145|141709674|EQUIVALENCE|Question: Is there a difference in the incidence of sticking of the vulva among the patients with vulvar discomfort?||||||0.0581|||||||Chi-squared|||Parameter: The difference in the incidence of sticking of the vulva among patients with vulvar discomfort.||||0.0581
70999962|NCT03803202|141506956|OTHER||Ratio of GMT|0.67|||||TWO_SIDED|95.0|0.15|3.01|||t-test, 2 sided|||Serotype 23F, Day 1||3.01|0.15|
70923968|NCT00812461|141340011|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.63|TWO_SIDED|95.0|0.67|1.27|||Adjusted Odds Ratio (OR) response|||The analysis of RSDRL used a logistic regression (LREG) model, with country, sex, Baseline DRL, and treatment as fixed effects, and missing values were imputed using individual-patient predicted values of TAC derived from the MMRM model.||1.27|0.67|0.630
70999963|NCT03803202|141506956|OTHER||Ratio of GMT|0.93|||||TWO_SIDED|95.0|0.5|1.74|||t-test, 2 sided|||Serotype 1, Day 30||1.74|0.50|
70999964|NCT03803202|141506956|OTHER||Ratio of GMT|0.72|||||TWO_SIDED|95.0|0.39|1.32|||t-test, 2 sided|||Serotype 1, Day 30||1.32|0.39|
70999965|NCT03803202|141506956|OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.35|1.39|||t-test, 2 sided|||Serotype 1, Day 30||1.39|0.35|
70999966|NCT03803202|141506956|OTHER||Ratio of GMT|1.09|||||TWO_SIDED|95.0|0.66|1.8|||t-test, 2 sided|||Serotype 3, Day 30||1.80|0.66|
70999967|NCT03803202|141506956|OTHER||Ratio of GMT|1.44|||||TWO_SIDED|95.0|0.9|2.29|||t-test, 2 sided|||Serotype 3, Day 30||2.29|0.90|
70999968|NCT03803202|141506956|OTHER||Ratio of GMT|1.28|||||TWO_SIDED|95.0|0.76|2.17|||t-test, 2 sided|||Serotype 3, Day 30||2.17|0.76|
70999969|NCT03803202|141506956|OTHER||Ratio of GMT|0.82|||||TWO_SIDED|95.0|0.5|1.35|||t-test, 2 sided|||Serotype 4, Day 30||1.35|0.50|
70999970|NCT03803202|141506956|OTHER||Ratio of GMT|0.5|||||TWO_SIDED|95.0|0.24|1.02|||t-test, 2 sided|||Serotype 4, Day 30||1.02|0.24|
70999971|NCT03803202|141506956|OTHER||Ratio of GMT|1.06|||||TWO_SIDED|95.0|0.6|1.89|||t-test, 2 sided|||Serotype 4, Day 30||1.89|0.60|
70999972|NCT03803202|141506956|OTHER||Ratio of GMT|0.69|||||TWO_SIDED|95.0|0.41|1.15|||t-test, 2 sided|||Serotype 5, Day 30||1.15|0.41|
70999973|NCT03803202|141506956|OTHER||Ratio of GMT|0.61|||||TWO_SIDED|95.0|0.31|1.2|||t-test, 2 sided|||Serotype 5, Day 30||1.20|0.31|
70999974|NCT03803202|141506956|OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.48|1.32|||t-test, 2 sided|||Serotype 5, Day 30||1.32|0.48|
70999975|NCT03803202|141506956|OTHER||Ratio of GMT|0.52|||||TWO_SIDED|95.0|0.28|0.98|||t-test, 2 sided|||Serotype 6A, Day 30||0.98|0.28|
70999976|NCT03803202|141506956|OTHER||Ratio of GMT|0.32|||||TWO_SIDED|95.0|0.15|0.68|||t-test, 2 sided|||Serotype 6A, Day 30||0.68|0.15|
70999977|NCT03803202|141506956|OTHER||Ratio of GMT|0.37|||||TWO_SIDED|95.0|0.21|0.66|||t-test, 2 sided|||Serotype 6A, Day 30||0.66|0.21|
70999978|NCT03803202|141506956|OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.42|1.18|||t-test, 2 sided|||Serotype 6B, Day 30||1.18|0.42|
70999979|NCT03803202|141506956|OTHER||Ratio of GMT|0.45|||||TWO_SIDED|95.0|0.25|0.83|||t-test, 2 sided|||Serotype 6B, Day 30||0.83|0.25|
70999980|NCT03803202|141506956|OTHER||Ratio of GMT|0.43|||||TWO_SIDED|95.0|0.24|0.76|||t-test, 2 sided|||Serotype 6B, Day 30||0.76|0.24|
70999981|NCT03803202|141506956|OTHER||Ratio of GMT|0.81|||||TWO_SIDED|95.0|0.51|1.29|||t-test, 2 sided|||Serotype 7F, Day 30||1.29|0.51|
70999982|NCT03803202|141506956|OTHER||Ratio of GMT|0.68|||||TWO_SIDED|95.0|0.47|0.99|||t-test, 2 sided|||Serotype 7F, Day 30||0.99|0.47|
70999983|NCT03803202|141506956|OTHER||Ratio of GMT|0.82|||||TWO_SIDED|95.0|0.53|1.25|||t-test, 2 sided|||Serotype 7F, Day 30||1.25|0.53|
71041987|NCT04480307|141593318|SUPERIORITY||LS Mean Difference|-0.002||||0.9472|TWO_SIDED|95.0|-0.052|0.049|||ANCOVA|||||0.049|-0.052|0.9472
71041988|NCT04480307|141593318|SUPERIORITY||Difference of change from Baseline|0.012|||||TWO_SIDED|95.0|-0.036|0.059|||Bayesian|Difference of change from Baseline a posteriori.||Bayesian analysis is done using a non-informative prior on the mean observed difference.||0.059|-0.036|
71041989|NCT04480307|141593319|SUPERIORITY||LS Mean Difference|0.154||||0.4027|TWO_SIDED|95.0|-0.216|0.524|||ANCOVA|||ANCOVA analysis for T1 lesion volume parameter||0.524|-0.216|0.4027
71041990|NCT04480307|141593319|SUPERIORITY||LS Mean Difference|0.01||||0.7428|TWO_SIDED|95.0|-0.051|0.071|||ANCOVA|||ANCOVA analysis for T2 lesion volume parameter||0.071|-0.051|0.7428
71041991|NCT04480307|141593320|SUPERIORITY||LS Mean Difference|0.003||||0.7314|TWO_SIDED|95.0|-0.013|0.018|||ANCOVA|||||0.018|-0.013|0.7314
71041992|NCT04480307|141593320|SUPERIORITY||Difference of change from Baseline|0.005|||||TWO_SIDED|95.0|-0.01|0.023|||Bayesian|Difference of change from Baseline a posteriori||Bayesian analysis is done using a non-informative prior on the mean observed difference.||0.023|-0.010|
71041993|NCT04480307|141593321|SUPERIORITY||LS Mean Difference|0.0||||0.7662|TWO_SIDED|95.0|0.0|0.0|||ANCOVA|||||0|0|0.7662
71100521|NCT02732145|141709674|EQUIVALENCE|Question: Is there a difference in the incidence of itching of the vulva among the patients with vulvar discomfort?||||||0.0002|||||||Chi-squared|||Parameter: The difference in the incidence of itching of the vulva among patients with vulvar discomfort.||||0.0002
70999984|NCT03803202|141506956|OTHER||Ratio of GMT|0.61|||||TWO_SIDED|95.0|0.35|1.08|||t-test, 2 sided|||Serotype 9V, Day 30||1.08|0.35|
70999985|NCT03803202|141506956|OTHER||Ratio of GMT|0.57|||||TWO_SIDED|95.0|0.31|1.03|||t-test, 2 sided|||Serotype 9V, Day 30||1.03|0.31|
70999986|NCT03803202|141506956|OTHER||Ratio of GMT|0.77|||||TWO_SIDED|95.0|0.46|1.28|||t-test, 2 sided|||Serotype 9V, Day 30||1.28|0.46|
70999987|NCT03803202|141506956|OTHER||Ratio of GMT|0.54|||||TWO_SIDED|95.0|0.27|1.08|||t-test, 2 sided|||Serotype 14, Day 30||1.08|0.27|
70999988|NCT03803202|141506956|OTHER||Ratio of GMT|0.28|||||TWO_SIDED|95.0|0.1|0.77|||t-test, 2 sided|||Serotype 14, Day 30||0.77|0.10|
70999989|NCT03803202|141506956|OTHER||Ratio of GMT|1.13|||||TWO_SIDED|95.0|0.56|2.3|||t-test, 2 sided|||Serotype 14, Day 30||2.30|0.56|
70999990|NCT03803202|141506956|OTHER||Ratio of GMT|0.89|||||TWO_SIDED|95.0|0.53|1.5|||t-test, 2 sided|||Serotype 18C, Day 30||1.50|0.53|
70999991|NCT03803202|141506956|OTHER||Ratio of GMT|0.69|||||TWO_SIDED|95.0|0.39|1.23|||t-test, 2 sided|||Serotype 18C, Day 30||1.23|0.39|
70999992|NCT03803202|141506956|OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.5|1.28|||t-test, 2 sided|||Serotype 18C, Day 30||1.28|0.50|
70999993|NCT03803202|141506956|OTHER||Ratio of GMT|0.5|||||TWO_SIDED|95.0|0.32|0.79|||t-test, 2 sided|||Serotype 19A, Day 30||0.79|0.32|
70999994|NCT03803202|141506956|OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.45|1.09|||t-test, 2 sided|||Serotype 19A, Day 30||1.09|0.45|
70999995|NCT03803202|141506956|OTHER||Ratio of GMT|0.63|||||TWO_SIDED|95.0|0.42|0.96|||t-test, 2 sided|||Serotype 19A, Day 30||0.96|0.42|
70999996|NCT03803202|141506956|OTHER||Ratio of GMT|0.56|||||TWO_SIDED|95.0|0.34|0.92|||t-test, 2 sided|||Serotype 19F, Day 30||0.92|0.34|
70999997|NCT03803202|141506956|OTHER||Ratio of GMT|0.64|||||TWO_SIDED|95.0|0.37|1.1|||t-test, 2 sided|||Serotype 19F, Day 30||1.10|0.37|
70999998|NCT03803202|141506956|OTHER||Ratio of GMT|0.93|||||TWO_SIDED|95.0|0.56|1.55|||t-test, 2 sided|||Serotype 19F, Day 30||1.55|0.56|
70999999|NCT03803202|141506956|OTHER||Ratio of GMT|0.2|||||TWO_SIDED|95.0|0.08|0.46|||t-test, 2 sided|||Serotype 23F, Day 30||0.46|0.08|
71000000|NCT03803202|141506956|OTHER||Ratio of GMT|0.2|||||TWO_SIDED|95.0|0.08|0.47|||t-test, 2 sided|||Serotype 23F, Day 30||0.47|0.08|
71000001|NCT03803202|141506956|OTHER||Ratio of GMT|0.23|||||TWO_SIDED|95.0|0.09|0.57|||t-test, 2 sided|||Serotype 23F, Day 30||0.57|0.09|
71000002|NCT03803202|141506957|OTHER||Ratio of GMC|1.08|||||TWO_SIDED|95.0|0.52|2.23|||t-test, 2 sided|||Serotype 1, Day 1||2.23|0.52|
71000003|NCT03803202|141506957|OTHER||Ratio of GMC|1.0|||||TWO_SIDED|95.0|0.51|1.98|||t-test, 2 sided|||Serotype 1, Day 1||1.98|0.51|
71000004|NCT03803202|141506957|OTHER||Ratio of GMC|1.43|||||TWO_SIDED|95.0|0.72|2.83|||t-test, 2 sided|||Serotype 1, Day 1||2.83|0.72|
71000005|NCT03803202|141506957|OTHER||Ratio of GMC|1.26|||||TWO_SIDED|95.0|0.59|2.68|||t-test, 2 sided|||Serotype 3, Day 1||2.68|0.59|
71000006|NCT03803202|141506957|OTHER||Ratio of GMC|1.65|||||TWO_SIDED|95.0|0.9|3.05|||t-test, 2 sided|||Serotype 3, Day 1||3.05|0.90|
71000007|NCT03803202|141506957|OTHER||Ratio of GMC|1.24|||||TWO_SIDED|95.0|0.68|2.25|||t-test, 2 sided|||Serotype 3, Day 1||2.25|0.68|
71000008|NCT03803202|141506957|OTHER||Ratio of GMC|1.03|||||TWO_SIDED|95.0|0.49|2.15|||t-test, 2 sided|||Serotype 4, Day 1||2.15|0.49|
71000009|NCT03803202|141506957|OTHER||Ratio of GMC|0.82|||||TWO_SIDED|95.0|0.39|1.74|||t-test, 2 sided|||Serotype 4, Day 1||1.74|0.39|
71000010|NCT03803202|141506957|OTHER||Ratio of GMC|1.24|||||TWO_SIDED|95.0|0.59|2.59|||t-test, 2 sided|||Serotype 4, Day 1||2.59|0.59|
71000011|NCT03803202|141506957|OTHER||Ratio of GMC|1.71|||||TWO_SIDED|95.0|0.75|3.91|||t-test, 2 sided|||Serotype 5, Day 1||3.91|0.75|
71000012|NCT03803202|141506957|OTHER||Ratio of GMC|0.72|||||TWO_SIDED|95.0|0.36|1.46|||t-test, 2 sided|||Serotype 5, Day 1||1.46|0.36|
71000013|NCT03803202|141506957|OTHER||Ratio of GMC|0.93|||||TWO_SIDED|95.0|0.47|1.84|||t-test, 2 sided|||Serotype 5, Day 1||1.84|0.47|
71000014|NCT03803202|141506957|OTHER||Ratio of GMC|1.19|||||TWO_SIDED|95.0|0.57|2.52|||t-test, 2 sided|||Serotype 6A, Day 1||2.52|0.57|
71000015|NCT03803202|141506957|OTHER||Ratio of GMC|1.28|||||TWO_SIDED|95.0|0.64|2.56|||t-test, 2 sided|||Serotype 6A, Day 1||2.56|0.64|
71000016|NCT03803202|141506957|OTHER||Ratio of GMC|1.09|||||TWO_SIDED|95.0|0.52|2.28|||t-test, 2 sided|||Serotype 6A, Day 1||2.28|0.52|
71000017|NCT03803202|141506957|OTHER||Ratio of GMC|1.23|||||TWO_SIDED|95.0|0.49|3.09|||t-test, 2 sided|||Serotype 6B, Day 1||3.09|0.49|
71000018|NCT03803202|141506957|OTHER||Ratio of GMC|0.96|||||TWO_SIDED|95.0|0.43|2.14|||t-test, 2 sided|||Serotype 6B, Day 1||2.14|0.43|
71000019|NCT03803202|141506957|OTHER||Ratio of GMC|0.81|||||TWO_SIDED|95.0|0.37|1.73|||t-test, 2 sided|||Serotype 6B, Day 1||1.73|0.37|
71000020|NCT03803202|141506957|OTHER||Ratio of GMC|1.51|||||TWO_SIDED|95.0|0.76|3.01|||t-test, 2 sided|||Serotype 7F, Day 1||3.01|0.76|
71000021|NCT03803202|141506957|OTHER||Ratio of GMC|1.16|||||TWO_SIDED|95.0|0.69|1.94|||t-test, 2 sided|||Serotype 7F, Day 1||1.94|0.69|
71000022|NCT03803202|141506957|OTHER||Ratio of GMC|1.69|||||TWO_SIDED|95.0|0.98|2.91|||t-test, 2 sided|||Serotype 7F, Day 1||2.91|0.98|
71000023|NCT03803202|141506957|OTHER||Ratio of GMC|1.09|||||TWO_SIDED|95.0|0.54|2.22|||t-test, 2 sided|||Serotype 9V, Day 1||2.22|0.54|
71000024|NCT03803202|141506957|OTHER||Ratio of GMC|0.74|||||TWO_SIDED|95.0|0.41|1.36|||t-test, 2 sided|||Serotype 9V, Day 1||1.36|0.41|
71000025|NCT03803202|141506957|OTHER||Ratio of GMC|0.85|||||TWO_SIDED|95.0|0.47|1.55|||t-test, 2 sided|||Serotype 9V, Day 1||1.55|0.47|
71000026|NCT03803202|141506957|OTHER||Ratio of GMC|2.05|||||TWO_SIDED|95.0|0.84|4.99|||t-test, 2 sided|||Serotype 14, Day 1||4.99|0.84|
71000027|NCT03803202|141506957|OTHER||Ratio of GMC|2.6|||||TWO_SIDED|95.0|1.13|5.98|||t-test, 2 sided|||Serotype 14, Day 1||5.98|1.13|
71000028|NCT03803202|141506957|OTHER||Ratio of GMC|0.89|||||TWO_SIDED|95.0|0.37|2.15|||t-test, 2 sided|||Serotype 14, Day 1||2.15|0.37|
71000029|NCT03803202|141506957|OTHER||Ratio of GMC|1.37|||||TWO_SIDED|95.0|0.61|3.06|||t-test, 2 sided|||Serotype 18C, Day 1||3.06|0.61|
71000030|NCT03803202|141506957|OTHER||Ratio of GMC|1.07|||||TWO_SIDED|95.0|0.55|2.09|||t-test, 2 sided|||Serotype 18C, Day 1||2.09|0.55|
71000031|NCT03803202|141506957|OTHER||Ratio of GMC|1.25|||||TWO_SIDED|95.0|0.59|2.65|||t-test, 2 sided|||Serotype 18C, Day 1||2.65|0.59|
71000032|NCT03803202|141506957|OTHER||Ratio of GMC|1.61|||||TWO_SIDED|95.0|0.74|3.49|||t-test, 2 sided|||Serotype 19A, Day 1||3.49|0.74|
71000033|NCT03803202|141506957|OTHER||Ratio of GMC|0.83|||||TWO_SIDED|95.0|0.42|1.65|||t-test, 2 sided|||Serotype 19A, Day 1||1.65|0.42|
71000034|NCT03803202|141506957|OTHER||Ratio of GMC|1.0|||||TWO_SIDED|95.0|0.49|2.05|||t-test, 2 sided|||Serotype 19A, Day 1||2.05|0.49|
71000035|NCT03803202|141506957|OTHER||Ratio of GMC|1.47|||||TWO_SIDED|95.0|0.63|3.39|||t-test, 2 sided|||Serotype 19F, Day 1||3.39|0.63|
71000036|NCT03803202|141506957|OTHER||Ratio of GMC|1.4|||||TWO_SIDED|95.0|0.64|3.07|||t-test, 2 sided|||Serotype 19F, Day 1||3.07|0.64|
71000037|NCT03803202|141506957|OTHER||Ratio of GMC|1.12|||||TWO_SIDED|95.0|0.53|2.34|||t-test, 2 sided|||Serotype 19F, Day 1||2.34|0.53|
71000038|NCT03803202|141506957|OTHER||Ratio of GMC|1.01|||||TWO_SIDED|95.0|0.49|2.09|||t-test, 2 sided|||Serotype 23F, Day 1||2.09|0.49|
71000039|NCT03803202|141506957|OTHER||Ratio of GMC|0.94|||||TWO_SIDED|95.0|0.5|1.75|||t-test, 2 sided|||Serotype 23F, Day 1||1.75|0.50|
71000040|NCT03803202|141506957|OTHER||Ratio of GMC|0.91|||||TWO_SIDED|95.0|0.42|2.0|||t-test, 2 sided|||Serotype 23F, Day 1||2.00|0.42|
71000041|NCT03803202|141506957|OTHER||Ratio of GMC|0.7|||||TWO_SIDED|95.0|0.38|1.29|||t-test, 2 sided|||Serotype 1, Day 30||1.29|0.38|
71000042|NCT03803202|141506957|OTHER||Ratio of GMC|0.95|||||TWO_SIDED|95.0|0.52|1.73|||t-test, 2 sided|||Serotype 1, Day 30||1.73|0.52|
71000043|NCT03803202|141506957|OTHER||Ratio of GMC|1.5|||||TWO_SIDED|95.0|0.84|2.66|||t-test, 2 sided|||Serotype 1, Day 30||2.66|0.84|
71000044|NCT03803202|141506957|OTHER||Ratio of GMC|1.38|||||TWO_SIDED|95.0|0.84|2.28|||t-test, 2 sided|||Serotype 3, Day 30||2.28|0.84|
71000045|NCT03803202|141506957|OTHER||Ratio of GMC|2.68|||||TWO_SIDED|95.0|1.71|4.19|||t-test, 2 sided|||Serotype 3, Day 30||4.19|1.71|
71000046|NCT03803202|141506957|OTHER||Ratio of GMC|3.87|||||TWO_SIDED|95.0|2.47|6.06|||t-test, 2 sided|||Serotype 3, Day 30||6.06|2.47|
71000047|NCT03803202|141506957|OTHER||Ratio of GMC|1.27|||||TWO_SIDED|95.0|0.7|2.3|||t-test, 2 sided|||Serotype 4, Day 30||2.30|0.70|
71000048|NCT03803202|141506957|OTHER||Ratio of GMC|1.02|||||TWO_SIDED|95.0|0.57|1.81|||t-test, 2 sided|||Serotype 4, Day 30||1.81|0.57|
71000049|NCT03803202|141506957|OTHER||Ratio of GMC|2.24|||||TWO_SIDED|95.0|1.21|4.15|||t-test, 2 sided|||Serotype 4, Day 30||4.15|1.21|
71000050|NCT03803202|141506957|OTHER||Ratio of GMC|1.58|||||TWO_SIDED|95.0|0.7|3.57|||t-test, 2 sided|||Serotype 5, Day 30||3.57|0.70|
71000051|NCT03803202|141506957|OTHER||Ratio of GMC|0.84|||||TWO_SIDED|95.0|0.35|2.05|||t-test, 2 sided|||Serotype 5, Day 30||2.05|0.35|
71000052|NCT03803202|141506957|OTHER||Ratio of GMC|1.49|||||TWO_SIDED|95.0|0.65|3.39|||t-test, 2 sided|||Serotype 5, Day 30||3.39|0.65|
71000053|NCT03803202|141506957|OTHER||Ratio of GMC|0.89|||||TWO_SIDED|95.0|0.41|1.93|||t-test, 2 sided|||Serotype 6A, Day 30||1.93|0.41|
71000054|NCT03803202|141506957|OTHER||Ratio of GMC|0.77|||||TWO_SIDED|95.0|0.33|1.79|||t-test, 2 sided|||Serotype 6A, Day 30||1.79|0.33|
71000055|NCT03803202|141506957|OTHER||Ratio of GMC|0.69|||||TWO_SIDED|95.0|0.32|1.48|||t-test, 2 sided|||Serotype 6A, Day 30||1.48|0.32|
71000056|NCT03803202|141506957|OTHER||Ratio of GMC|1.26|||||TWO_SIDED|95.0|0.57|2.83|||t-test, 2 sided|||Serotype 6B, Day 30||2.83|0.57|
71000057|NCT03803202|141506957|OTHER||Ratio of GMC|0.75|||||TWO_SIDED|95.0|0.31|1.81|||t-test, 2 sided|||Serotype 6B, Day 30||1.81|0.31|
71000058|NCT03803202|141506957|OTHER||Ratio of GMC|0.88|||||TWO_SIDED|95.0|0.39|1.97|||t-test, 2 sided|||Serotype 6B, Day 30||1.97|0.39|
71000059|NCT03803202|141506957|OTHER||Ratio of GMC|1.86|||||TWO_SIDED|95.0|1.05|3.3|||t-test, 2 sided|||Serotype 7F, Day 30||3.30|1.05|
71000060|NCT03803202|141506957|OTHER||Ratio of GMC|1.98|||||TWO_SIDED|95.0|1.1|3.55|||t-test, 2 sided|||Serotype 7F, Day 30||3.55|1.10|
71000061|NCT03803202|141506957|OTHER||Ratio of GMC|2.88|||||TWO_SIDED|95.0|1.62|5.12|||t-test, 2 sided|||Serotype 7F, Day 30||5.12|1.62|
71000062|NCT03803202|141506957|OTHER||Ratio of GMC|0.96|||||TWO_SIDED|95.0|0.49|1.87|||t-test, 2 sided|||Serotype 9V, Day 30||1.87|0.49|
71000063|NCT03803202|141506957|OTHER||Ratio of GMC|1.39|||||TWO_SIDED|95.0|0.74|2.62|||t-test, 2 sided|||Serotype 9V, Day 30||2.62|0.74|
71000064|NCT03803202|141506957|OTHER||Ratio of GMC|1.68|||||TWO_SIDED|95.0|0.87|3.27|||t-test, 2 sided|||Serotype 9V, Day 30||3.27|0.87|
71000065|NCT03803202|141506957|OTHER||Ratio of GMC|1.01|||||TWO_SIDED|95.0|0.41|2.53|||t-test, 2 sided|||Serotype 14, Day 30||2.53|0.41|
71000066|NCT03803202|141506957|OTHER||Ratio of GMC|1.08|||||TWO_SIDED|95.0|0.45|2.6|||t-test, 2 sided|||Serotype 14, Day 30||2.60|0.45|
71000067|NCT03803202|141506957|OTHER||Ratio of GMC|2.09|||||TWO_SIDED|95.0|0.86|5.04|||t-test, 2 sided|||Serotype 14, Day 30||5.04|0.86|
71000068|NCT03803202|141506957|OTHER||Ratio of GMC|1.09|||||TWO_SIDED|95.0|0.57|2.07|||t-test, 2 sided|||Serotype 18C, Day 30||2.07|0.57|
71000069|NCT03803202|141506957|OTHER||Ratio of GMC|1.0|||||TWO_SIDED|95.0|0.53|1.89|||t-test, 2 sided|||Serotype 18C, Day 30||1.89|0.53|
71000070|NCT03803202|141506957|OTHER||Ratio of GMC|1.08|||||TWO_SIDED|95.0|0.56|2.07|||t-test, 2 sided|||Serotype 18C, Day 30||2.07|0.56|
71000071|NCT03803202|141506957|OTHER||Ratio of GMC|0.68|||||TWO_SIDED|95.0|0.4|1.14|||t-test, 2 sided|||Serotype 19A, Day 30||1.14|0.40|
71000072|NCT03803202|141506957|OTHER||Ratio of GMC|0.86|||||TWO_SIDED|95.0|0.46|1.61|||t-test, 2 sided|||Serotype 19A, Day 30||1.61|0.46|
71000073|NCT03803202|141506957|OTHER||Ratio of GMC|0.87|||||TWO_SIDED|95.0|0.47|1.6|||t-test, 2 sided|||Serotype 19A, Day 30||1.60|0.47|
71000074|NCT03803202|141506957|OTHER||Ratio of GMC|1.0|||||TWO_SIDED|95.0|0.49|2.01|||t-test, 2 sided|||Serotype 19F, Day 30||2.01|0.49|
71000075|NCT03803202|141506957|OTHER||Ratio of GMC|1.38|||||TWO_SIDED|95.0|0.75|2.53|||t-test, 2 sided|||Serotype 19F, Day 30||2.53|0.75|
71000076|NCT03803202|141506957|OTHER||Ratio of GMC|1.41|||||TWO_SIDED|95.0|0.68|2.96|||t-test, 2 sided|||Serotype 19F, Day 30||2.96|0.68|
71000077|NCT03803202|141506957|OTHER||Ratio of GMC|0.46|||||TWO_SIDED|95.0|0.2|1.07|||t-test, 2 sided|||Serotype 23F, Day 30||1.07|0.20|
71000078|NCT03803202|141506957|OTHER||Ratio of GMC|0.5|||||TWO_SIDED|95.0|0.22|1.11|||t-test, 2 sided|||Serotype 23F, Day 30||1.11|0.22|
71000079|NCT03803202|141506957|OTHER||Ratio of GMC|0.64|||||TWO_SIDED|95.0|0.29|1.44|||t-test, 2 sided|||Serotype 23F, Day 30||1.44|0.29|
71000080|NCT03803202|141506961|OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.56|1.14|||t-test, 2 sided|||Serotype 1, Day 1||1.14|0.56|
71000081|NCT03803202|141506961|OTHER||Ratio of GMT|1.39|||||TWO_SIDED|95.0|0.89|2.16|||t-test, 2 sided|||Serotype 1, Day 1||2.16|0.89|
71000082|NCT03803202|141506961|OTHER||Ratio of GMT|0.73|||||TWO_SIDED|95.0|0.51|1.06|||t-test, 2 sided|||Serotype 1, Day 1||1.06|0.51|
71000083|NCT03803202|141506961|OTHER||Ratio of GMT|1.33|||||TWO_SIDED|95.0|0.85|2.09|||t-test, 2 sided|||Serotype 3, Day 1||2.09|0.85|
71000084|NCT03803202|141506961|OTHER||Ratio of GMT|1.45|||||TWO_SIDED|95.0|0.91|2.3|||t-test, 2 sided|||Serotype 3, Day 1||2.30|0.91|
71000085|NCT03803202|141506961|OTHER||Ratio of GMT|0.95|||||TWO_SIDED|95.0|0.6|1.49|||t-test, 2 sided|||Serotype 3, Day 1||1.49|0.60|
71000086|NCT03803202|141506961|OTHER||Ratio of GMT|0.81|||||TWO_SIDED|95.0|0.46|1.4|||t-test, 2 sided|||Serotype 4, Day 1||1.40|0.46|
71000087|NCT03803202|141506961|OTHER||Ratio of GMT|1.09|||||TWO_SIDED|95.0|0.62|1.91|||t-test, 2 sided|||Serotype 4, Day 1||1.91|0.62|
71041994|NCT00108550|141593333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0305|STANDARD_ERROR_OF_MEAN|0.038||0.4237|TWO_SIDED|95.0|-0.044|0.105||There was no need for multiple comparisons adjustment for the primary outcome, since there was only one. However, secondary analyses were adjusted for multiple comparisons.|Mixed Models Analysis|Effect of covariates (age, gender, etc) was evaluated (modeled as fixed effects) in secondary analyses.|The analysis was performed on transformed (rather than raw) Descriptor Differential Score Pain Intensity scores.|The null hypothesis was that Gabapentin is no better than placebo in reducing back pain. A mean-matching variance stabilizing transformation was applied to Descriptor Differential Scale Pain intensity (DDS) scores. Scores were modeled as a function of time (week) and group (gabapentin, placebo) in a mixed effects model. Random (subject-specific)intercept and slopes were fitted to the data. With alpha = .05 and N = 65 per group power is .8 to detect effect size =.4 standard deviations (SD).||0.105|-0.044|0.4237
71041995|NCT00108550|141593334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5343|STANDARD_ERROR_OF_MEAN|0.7174||0.458|TWO_SIDED|95.0|-1.94|0.872||Primary analyses was multivariable linear regression with fixed and random effects. After the Bonferroni adjustment a p-value would have been considered significant at 0.05 level if \<0.01.|Mixed Models Analysis|||This is a secondary analysis; the null hypothesis is that Gabapentin performs no better than placebo in reducing the Roland and Morris score.||0.872|-1.940|0.458
71041996|NCT02010996|141593411|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Chi-squared|||||||0.05
71041997|NCT05103657|141593428|OTHER||Mean Difference (Net)|0.06||||0.9726|TWO_SIDED|95.0|-3.31|3.43|||Mixed Models for repeated measures||"Least Squares mean of BI 1358894 125 mg - Least Square mean of Placebo."|Least Squares (LS) means differences and confidence intervals were estimated by REML-based MMRM including the fixed categorical covariates of treatment, and the stratification indicator of presence of significant childhood trauma (yes vs. no), the continuous fixed covariate of baseline CAPS-5 total severity score, time since index event (in years) and the treatment-by-visit interaction. Patient is considered as random. Unstructured covariance matrix was used.||3.43|-3.31|0.9726
71041998|NCT05103657|141593429|OTHER||Odds Ratio (OR)|1.002||||0.9945|TWO_SIDED|95.0|0.608|1.65|||Regression, Logistic||BI 1358894 125 mg vs. Placebo|Logistic regression was adjusted for fixed factors of treatment and presence of significant childhood trauma (yes vs. no).||1.650|0.608|0.9945
71041999|NCT05103657|141593430|OTHER||Odds Ratio (OR)|0.912||||0.7167|TWO_SIDED|95.0|0.552|1.504|||Regression, Logistic||BI 1358894 125 mg vs. Placebo|Logistic regression was adjusted for fixed factors of treatment and presence of significant childhood trauma (yes vs. no).||1.504|0.552|0.7167
71042000|NCT05103657|141593431|OTHER||Mean Difference (Net)|0.66||||0.723|TWO_SIDED|95.0|-3.0|4.32|||Mixed Models for Repeated Measures||"Least Square mean of BI 1358894 125 mg - Least Square mean of Placebo."|Least Square (LS) means differences and confidence intervals were estimated by REML-based MMRM including the fixed categorical covariates of treatment, and the stratification indicator of presence of significant childhood trauma (yes vs. no), the continuous fixed covariate of baseline CAPS-5 total severity score, time since index event (in years) and the treatment-by-visit interaction. Patient is considered as random. Unstructured covariance matrix was used.||4.32|-3.00|0.7230
71042001|NCT04234464|141593437|SUPERIORITY||Mean Difference (Final Values)|13.51|||<|0.001|TWO_SIDED|95.0|10.09|16.94|||Mixed Models Analysis|||Maximum percentage fall in post-dose pre-exercise FEV₁ up to 60 minutes post-exercise challenge is analyzed using a mixed effects model adjusted for treatment, treatment period, treatment sequence as categorical fixed effects, period-specific pre-dose baseline FEV₁ and average pre-dose baseline FEV₁ as continuous covariates, and a random subject within treatment sequence effect.||16.94|10.09|<0.001
71042002|NCT04234464|141593438|SUPERIORITY||Odds Ratio (OR)|10.548|||<|0.001|TWO_SIDED|95.0|4.311|25.805|||Mixed Models Analysis|||A generalized linear mixed model with logit link adjusted for treatment, treatment period and treatment sequence as fixed effects, pre-dose baseline FEV₁ and average pre-dose baseline FEV₁ as continuous covariates, and a random subject within treatment sequence effect.||25.805|4.311|<0.001
71042003|NCT03635983|141593439|SUPERIORITY||Estimate of Odds Ratio (OR)|0.66||||0.0311|TWO_SIDED|95.0|0.45|0.96|||Stratified Cochran-Mantel-Haenszel|two-sided|Strata adjusted odds ratio (NKTR-214 + Nivolumab over Nivolumab) using Mantel-Haenszel method.|Bempegaldesleukin+Nivolumab over Nivolumab||0.96|0.45|0.0311
71042004|NCT03635983|141593440|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.3988||95.0|0.89|1.33||Log-rank stratified 2-sided. Boundary for statistical significance p-value \< 0.03|Log Rank||Stratified Cox proportional hazard model. Hazard Ratio is NKTR-214 + Nivolumab over Nivolumab|||1.33|0.89|0.3988
71000088|NCT03803202|141506961|OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.4|1.23|||t-test, 2 sided|||Serotype 4, Day 1||1.23|0.40|
71000089|NCT03803202|141506961|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.58|1.68|||t-test, 2 sided|||Serotype 5, Day 1||1.68|0.58|
71042005|NCT03635983|141593441|SUPERIORITY|Bempegaldesleukin+Nivolumab over Nivolumab|Hazard Ratio (HR)|0.94||||0.6361|TWO_SIDED|95.0|0.72|1.22|||Log Rank|2-sided p-value. Boundary for statistical significance p-value \< 0.00071|Stratified Cox proportional hazard model. Hazard Ratio is NKTR-214 + Nivolumab over Nivolumab.|||1.22|0.72|0.6361
71000090|NCT03803202|141506961|OTHER||Ratio of GMT|1.32|||||TWO_SIDED|95.0|0.76|2.29|||t-test, 2 sided|||Serotype 5, Day 1||2.29|0.76|
71000091|NCT03803202|141506961|OTHER||Ratio of GMT|0.88|||||TWO_SIDED|95.0|0.51|1.53|||t-test, 2 sided|||Serotype 5, Day 1||1.53|0.51|
71000092|NCT03803202|141506961|OTHER||Ratio of GMT|0.96|||||TWO_SIDED|95.0|0.54|1.72|||t-test, 2 sided|||Serotype 6A, Day 1||1.72|0.54|
71000093|NCT03803202|141506961|OTHER||Ratio of GMT|1.1|||||TWO_SIDED|95.0|0.57|2.14|||t-test, 2 sided|||Serotype 6B, Day 1||2.14|0.57|
71042006|NCT03635983|141593445|SUPERIORITY||Estimate of Odds Ratio (OR)|0.7||||0.0626|TWO_SIDED|95.0|0.48|1.02|||Stratified Cochran-Mantel-Haenszel|two-sided|Strata adjusted odds ratio (NKTR-214 + Nivolumab over Nivolumab) using Mantel-Haenszel method.|Bempegaldesleukin+Nivolumab over Nivolumab||1.02|0.48|0.0626
71000094|NCT03803202|141506961|OTHER||Ratio of GMT|1.63|||||TWO_SIDED|95.0|0.86|3.1|||t-test, 2 sided|||Serotype 6A, Day 1||3.10|0.86|
71000095|NCT03803202|141506961|OTHER||Ratio of GMT|1.61|||||TWO_SIDED|95.0|0.83|3.14|||t-test, 2 sided|||Serotype 6A, Day 1||3.14|0.83|
71000096|NCT03803202|141506961|OTHER||Ratio of GMT|1.15|||||TWO_SIDED|95.0|0.59|2.24|||t-test, 2 sided|||Serotype 6B, Day 1||2.24|0.59|
71000097|NCT03803202|141506961|OTHER||Ratio of GMT|1.18|||||TWO_SIDED|95.0|0.58|2.39|||t-test, 2 sided|||Serotype 6B, Day 1||2.39|0.58|
71000098|NCT03803202|141506961|OTHER||Ratio of GMT|0.84|||||TWO_SIDED|95.0|0.4|1.8|||t-test, 2 sided|||Serotype 7F, Day 1||1.80|0.40|
71000099|NCT03803202|141506961|OTHER||Ratio of GMT|1.35|||||TWO_SIDED|95.0|0.63|2.87|||t-test, 2 sided|||Serotype 7F, Day 1||2.87|0.63|
71000100|NCT03803202|141506961|OTHER||Ratio of GMT|1.03|||||TWO_SIDED|95.0|0.45|2.37|||t-test, 2 sided|||Serotype 7F, Day 1||2.37|0.45|
71000101|NCT03803202|141506961|OTHER||Ratio of GMT|0.65||||||95.0|0.32|1.32|||t-test, 2 sided|||Serotype 9V, Day 1||1.32|0.32|
71000102|NCT03803202|141506961|OTHER||Ratio of GMT|0.78|||||TWO_SIDED|95.0|0.37|1.64|||t-test, 2 sided|||Serotype 9V, Day 1||1.64|0.37|
71000103|NCT03803202|141506961|OTHER||Ratio of GMT|0.66|||||TWO_SIDED|95.0|0.3|1.49|||t-test, 2 sided|||Serotype 9V, Day 1||1.49|0.30|
71000104|NCT03803202|141506961|OTHER||Ratio of GMT|0.61|||||TWO_SIDED|95.0|0.31|1.18|||t-test, 1 sided|||Serotype 14, Day 1||1.18|0.31|
71000105|NCT03803202|141506961|OTHER||Ratio of GMT|1.09|||||TWO_SIDED|95.0|0.54|2.18|||t-test, 2 sided|||Serotype 14, Day 1||2.18|0.54|
71000106|NCT03803202|141506961|OTHER||Ratio of GMT|1.32|||||TWO_SIDED|95.0|0.66|2.65|||t-test, 2 sided|||Serotype 14, Day 1||2.65|0.66|
71000107|NCT03803202|141506961|OTHER||Ratio of GMT|0.54|||||TWO_SIDED|95.0|0.3|0.95|||t-test, 2 sided|||Serotype 18C, Day 1||0.95|0.30|
71000108|NCT03803202|141506961|OTHER||Ratio of GMT|1.37|||||TWO_SIDED|95.0|0.73|2.57|||t-test, 2 sided|||Serotype 18C, Day 1||2.57|0.73|
71000109|NCT03803202|141506961|OTHER||Ratio of GMT|0.58|||||TWO_SIDED|95.0|0.32|1.04|||t-test, 2 sided|||Serotype 18C, Day 1||1.04|0.32|
71000110|NCT03803202|141506961|OTHER||Ratio of GMT|0.76|||||TWO_SIDED|95.0|0.44|1.32|||t-test, 2 sided|||Serotype 19A, Day 1||1.32|0.44|
71000111|NCT03803202|141506961|OTHER||Ratio of GMT|1.15|||||TWO_SIDED|95.0|0.66|2.01|||t-test, 2 sided|||Serotype 19A, Day 1||2.01|0.66|
71000112|NCT03803202|141506961|OTHER||Ratio of GMT|0.84|||||TWO_SIDED|95.0|0.48|1.5|||t-test, 2 sided|||Serotype 19A, Day 1||1.50|0.48|
71000113|NCT03803202|141506961|OTHER||Ratio of GMT|0.79|||||TWO_SIDED|95.0|0.45|1.38|||t-test, 2 sided|||Serotype 19F, Day 1||1.38|0.45|
71000114|NCT03803202|141506961|OTHER||Ratio of GMT|0.84|||||TWO_SIDED|95.0|0.47|1.52|||t-test, 2 sided|||Serotype 19F, Day 1||1.52|0.47|
71000115|NCT03803202|141506961|OTHER||Ratio of GMT|0.62|||||TWO_SIDED|95.0|0.34|1.12|||t-test, 2 sided|||Serotype 19F, Day 1||1.12|0.34|
71000116|NCT03803202|141506961|OTHER||Ratio of GMT|1.11|||||TWO_SIDED|95.0|0.64|1.94|||t-test, 2 sided|||Serotype 23F, Day 1||1.94|0.64|
71000117|NCT03803202|141506961|OTHER||Ratio of GMT|1.37|||||TWO_SIDED|95.0|0.77|2.42|||t-test, 2 sided|||Serotype 23F, Day 1||2.42|0.77|
71000118|NCT03803202|141506961|OTHER||Ratio of GMT|1.19|||||TWO_SIDED|95.0|0.66|2.14|||t-test, 2 sided|||Serotype 23F, Day 1||2.14|0.66|
71100522|NCT02732145|141709674|EQUIVALENCE|Question: Is there a difference in the incidence of the feeling of inflammation of the vulva among the patients with vulvar discomfort?|t-test proportion|0.0||||0.0852|TWO_SIDED||||||Chi-squared|||Parameter: The difference in the incidence of the feeling of inflammation of the vulva among patients with vulvar discomfort.||||0.0852
71000119|NCT03803202|141506961|OTHER||Ratio of GMT|0.83|||||TWO_SIDED|95.0|0.47|1.47|||t-test, 2 sided|||Serotype 1, Day 30||1.47|0.47|
71000120|NCT03803202|141506961|OTHER||Ratio of GMT|0.87|||||TWO_SIDED|95.0|0.5|1.53|||t-test, 2 sided|||Serotype 1, Day 30||1.53|0.50|
71000121|NCT03803202|141506961|OTHER||Ratio of GMT|1.28|||||TWO_SIDED|95.0|0.74|2.2|||t-test, 2 sided|||Serotype 1, Day 30||2.20|0.74|
71000122|NCT03803202|141506961|OTHER||Ratio of GMT|25.03|||||TWO_SIDED|95.0|16.33|38.34|||t-test, 2 sided|||Serotype 2, Day 30||38.34|16.33|
71000123|NCT03803202|141506961|OTHER||Ratio of GMT|21.99|||||TWO_SIDED|95.0|14.31|33.77|||t-test, 2 sided|||Serotype 2, Day 30||33.77|14.31|
71000124|NCT03803202|141506961|OTHER||Ratio of GMT|35.38|||||TWO_SIDED|95.0|23.09|54.22|||t-test, 2 sided|||Serotype 2, Day 30||54.22|23.09|
71000125|NCT03803202|141506961|OTHER||Ratio of GMT|1.81|||||TWO_SIDED|95.0|1.25|2.62|||t-test, 2 sided|||Serotype 3, Day 30||2.62|1.25|
71000126|NCT03803202|141506961|OTHER||Ratio of GMT|2.55|||||TWO_SIDED|95.0|1.83|3.56|||t-test, 2 sided|||Serotype 3, Day 30||3.56|1.83|
71000127|NCT03803202|141506961|OTHER||Ratio of GMT|3.14|||||TWO_SIDED|95.0|2.2|4.48|||t-test, 2 sided|||Serotype 3, Day 30||4.48|2.20|
71000128|NCT03803202|141506961|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.59|1.62|||t-test, 2 sided|||Serotype 4, Day 30||1.62|0.59|
71000129|NCT03803202|141506961|OTHER||Ratio of GMT|0.94|||||TWO_SIDED|95.0|0.59|1.51|||t-test, 2 sided|||Serotype 4, Day 30||1.51|0.59|
71000130|NCT03803202|141506961|OTHER||Ratio of GMT|1.23|||||TWO_SIDED|95.0|0.76|1.99|||t-test, 2 sided|||Serotype 4, Day 30||1.99|0.76|
71000131|NCT03803202|141506961|OTHER||Ratio of GMT|1.25|||||TWO_SIDED|95.0|0.71|2.21|||t-test, 2 sided|||Serotype 5, Day 30||2.21|0.71|
71000132|NCT03803202|141506961|OTHER||Ratio of GMT|1.45|||||TWO_SIDED|95.0|0.85|2.46|||t-test, 2 sided|||Serotype 5, Day 30||2.46|0.85|
71000133|NCT03803202|141506961|OTHER||Ratio of GMT|2.15|||||TWO_SIDED|95.0|1.25|3.72|||t-test, 2 sided|||Serotype 5, Day 30||3.72|1.25|
71000134|NCT03803202|141506961|OTHER||Ratio of GMT|0.94|||||TWO_SIDED|95.0|0.59|1.51|||t-test, 2 sided|||Serotype 6B, Day 30||1.51|0.59|
71000135|NCT03803202|141506961|OTHER||Ratio of GMT|0.85|||||TWO_SIDED|95.0|0.56|1.29|||t-test, 2 sided|||Serotype 6B, Day 30||1.29|0.56|
71000136|NCT03803202|141506961|OTHER||Ratio of GMT|0.84|||||TWO_SIDED|95.0|0.54|1.3|||t-test, 2 sided|||Serotype 6B, Day 30||1.30|0.54|
71000137|NCT03803202|141506961|OTHER||Ratio of GMT|0.85|||||TWO_SIDED|95.0|0.61|1.18|||t-test, 2 sided|||Serotype 7F, Day 30||1.18|0.61|
71000138|NCT03803202|141506961|OTHER||Ratio of GMT|0.89|||||TWO_SIDED|95.0|0.65|1.21|||t-test, 2 sided|||Serotype 7F, Day 30||1.21|0.65|
71000139|NCT03803202|141506961|OTHER||Ratio of GMT|1.05|||||TWO_SIDED|95.0|0.73|1.5|||t-test, 2 sided|||Serotype 7F, Day 30||1.50|0.73|
71000140|NCT03803202|141506961|OTHER||Ratio of GMT|19.46|||||TWO_SIDED|95.0|12.26|30.87|||t-test, 2 sided|||Serotype 8, Day 30||30.87|12.26|
71000141|NCT03803202|141506961|OTHER||Ratio of GMT|19.65|||||TWO_SIDED|95.0|12.07|32.0|||t-test, 2 sided|||Serotype 8, Day 30||32.00|12.07|
71000142|NCT03803202|141506961|OTHER||Ratio of GMT|41.87|||||TWO_SIDED|95.0|26.2|66.9|||t-test, 2 sided|||Serotype 8, Day 30||66.90|26.20|
71000143|NCT03803202|141506961|OTHER||Ratio of GMT|4.75|||||TWO_SIDED|95.0|3.06|7.36|||t-test, 2 sided|||Serotype 9N, Day 30||7.36|3.06|
71000144|NCT03803202|141506961|OTHER||Ratio of GMT|5.66|||||TWO_SIDED|95.0|3.83|8.37|||t-test, 2 sided|||Serotype 9N, Day 30||8.37|3.83|
71000145|NCT03803202|141506961|OTHER||Ratio of GMT|7.84|||||TWO_SIDED|95.0|5.19|11.82|||t-test, 2 sided|||Serotype 9N, Day 30||11.82|5.19|
71000146|NCT03803202|141506961|OTHER||Ratio of GMT|0.83|||||TWO_SIDED|95.0|0.49|1.42|||t-test, 2 sided|||Serotype 9V, Day 30||1.42|0.49|
71000147|NCT03803202|141506961|OTHER||Ratio of GMT|0.71|||||TWO_SIDED|95.0|0.44|1.14|||t-test, 2 sided|||Serotype 9V, Day 30||1.14|0.44|
71000148|NCT03803202|141506961|OTHER||Ratio of GMT|1.21|||||TWO_SIDED|95.0|0.76|1.95|||t-test, 2 sided|||Serotype 9V, Day 30||1.95|0.76|
71000149|NCT03803202|141506961|OTHER||Ratio of GMT|0.69|||||TWO_SIDED|95.0|0.39|1.21|||t-test, 2 sided|||Serotype 6A, Day 30||1.21|0.39|
71000150|NCT03803202|141506961|OTHER||Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.54|1.5|||t-test, 2 sided|||Serotype 6A, Day 30||1.50|0.54|
71000151|NCT03803202|141506961|OTHER||Ratio of GMT|0.93|||||TWO_SIDED|95.0|0.53|1.64|||t-test, 2 sided|||Serotype 6A, Day 30||1.64|0.53|
71000152|NCT03803202|141506961|OTHER||Ratio of GMT|1.33|||||TWO_SIDED|95.0|0.84|2.11|||t-test, 2 sided|||Serotype 14, Day 30||2.11|0.84|
71000153|NCT03803202|141506961|OTHER||Ratio of GMT|0.89|||||TWO_SIDED|95.0|0.55|1.43|||t-test, 2 sided|||Serotype 14, Day 30||1.43|0.55|
71000154|NCT03803202|141506961|OTHER||Ratio of GMT|1.54|||||TWO_SIDED|95.0|0.95|2.5|||t-test, 2 sided|||Serotype 14, Day 30||2.50|0.95|
71000155|NCT03803202|141506961|OTHER||Ratio of GMT|0.89|||||TWO_SIDED|95.0|0.55|1.44|||t-test, 2 sided|||Serotype 18C, Day 30||1.44|0.55|
71000156|NCT03803202|141506961|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.63|1.54|||t-test, 2 sided|||Serotype 18C, Day 30||1.54|0.63|
71000157|NCT03803202|141506961|OTHER||Ratio of GMT|1.32|||||TWO_SIDED|95.0|0.82|2.12|||t-test, 2 sided|||Serotype 18C, Day 30||2.12|0.82|
71000158|NCT03803202|141506961|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.7|1.37|||t-test, 2 sided|||Serotype 19A, Day 30||1.37|0.70|
71000159|NCT03803202|141506961|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.71|1.37|||t-test, 2 sided|||Serotype 19A, Day 30||1.37|0.71|
71000160|NCT03803202|141506961|OTHER||Ratio of GMT|1.14|||||TWO_SIDED|95.0|0.78|1.67|||t-test, 2 sided|||Serotype 19A, Day 30||1.67|0.78|
71000161|NCT03803202|141506961|OTHER||Ratio of GMT|1.52||||||95.0|0.99|2.32|||t-test, 2 sided|||Serotype 19F, Day 30||2.32|0.99|
71042007|NCT03635983|141593446|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.3713||95.0|0.9|1.33||Log-rank stratified 2-sided. Boundary for statistical significance p-value \< 0.03|Log Rank||Stratified Cox proportional hazard model. Hazard Ratio is NKTR-214 + Nivolumab over Nivolumab|||1.33|0.90|0.3713
71000162|NCT03803202|141506961|OTHER||Ratio of GMT|1.48|||||TWO_SIDED|95.0|1.0|2.18|||t-test, 2 sided|||Serotype 19F, Day 30||2.18|1.00|
71000163|NCT03803202|141506961|OTHER||Ratio of GMT|2.08|||||TWO_SIDED|95.0|1.35|3.22|||t-test, 2 sided|||Serotype 19F, Day 30||3.22|1.35|
71000164|NCT03803202|141506961|OTHER||Ratio of GMT|0.67|||||TWO_SIDED|95.0|0.36|1.26|||t-test, 2 sided|||Serotype 23F, Day 30||1.26|0.36|
71000165|NCT03803202|141506961|OTHER||Ratio of GMT|0.71|||||TWO_SIDED|95.0|0.4|1.26|||t-test, 2 sided|||Serotype 23F, Day 30||1.26|0.40|
71000166|NCT03803202|141506961|OTHER||Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.47|1.73|||t-test, 2 sided|||Serotype 23F, Day 30||1.73|0.47|
71000167|NCT03803202|141506962|OTHER||Ratio of GMC|0.9|||||TWO_SIDED|95.0|0.57|1.42|||t-test, 2 sided|||Serotype 1, Day 1||1.42|0.57|
71000168|NCT03803202|141506962|OTHER||Ratio of GMC|1.85|||||TWO_SIDED|95.0|1.12|3.08|||t-test, 2 sided|||Serotype 1, Day 1||3.08|1.12|
71000169|NCT03803202|141506962|OTHER||Ratio of GMC|0.88|||||TWO_SIDED|95.0|0.53|1.49|||t-test, 2 sided|||Serotype 1, Day 1||1.49|0.53|
71000170|NCT03803202|141506962|OTHER||Ratio of GMC|1.25|||||TWO_SIDED|95.0|0.84|1.87|||t-test, 2 sided|||Serotype 3, Day 1||1.87|0.84|
71000171|NCT03803202|141506962|OTHER||Ratio of GMC|1.79|||||TWO_SIDED|95.0|1.18|2.73|||t-test, 2 sided|||Serotype 3, Day 1||2.73|1.18|
71000172|NCT03803202|141506962|OTHER||Ratio of GMC|1.08|||||TWO_SIDED|95.0|0.69|1.69|||t-test, 2 sided|||Serotype 3, Day 1||1.69|0.69|
71000173|NCT03803202|141506962|OTHER||Ratio of GMC|0.81|||||TWO_SIDED|95.0|0.54|1.21|||t-test, 2 sided|||Serotype 4, Day 1||1.21|0.54|
71000174|NCT03803202|141506962|OTHER||Ratio of GMC|1.16|||||TWO_SIDED|95.0|0.74|1.81|||t-test, 2 sided|||Serotype 4, Day 1||1.81|0.74|
71000175|NCT03803202|141506962|OTHER||Ratio of GMC|0.67|||||TWO_SIDED|95.0|0.44|1.0|||t-test, 2 sided|||Serotype 4, Day 1||1.00|0.44|
71000176|NCT03803202|141506962|OTHER||Ratio of GMC|1.08|||||TWO_SIDED|95.0|0.65|1.78|||t-test, 2 sided|||Serotype 5, Day 1||1.78|0.65|
71000177|NCT03803202|141506962|OTHER||Ratio of GMC|1.59|||||TWO_SIDED|95.0|0.96|2.63|||t-test, 2 sided|||Serotype 5, Day 1||2.63|0.96|
71000178|NCT03803202|141506962|OTHER||Ratio of GMC|1.0|||||TWO_SIDED|95.0|0.58|1.72|||t-test, 2 sided|||Serotype 5, Day 1||1.72|0.58|
71000179|NCT03803202|141506962|OTHER||Ratio of GMC|0.88|||||TWO_SIDED|95.0|0.53|1.47|||t-test, 2 sided|||Serotype 6A, Day 1||1.47|0.53|
71000180|NCT03803202|141506962|OTHER||Ratio of GMC|1.39|||||TWO_SIDED|95.0|0.83|2.3|||t-test, 2 sided|||Serotype 6A, Day 1||2.30|0.83|
71000181|NCT03803202|141506962|OTHER||Ratio of GMC|1.4|||||TWO_SIDED|95.0|0.8|2.44|||t-test, 2 sided|||Serotype 6A, Day 1||2.44|0.80|
71000182|NCT03803202|141506962|OTHER||Ratio of GMC|1.17|||||TWO_SIDED|95.0|0.69|1.99|||t-test, 2 sided|||Serotype 6B, Day 1||1.99|0.69|
71000183|NCT03803202|141506962|OTHER||Ratio of GMC|2.09|||||TWO_SIDED|95.0|1.19|3.67|||t-test, 2 sided|||Serotype 6B, Day 1||3.67|1.19|
71000184|NCT03803202|141506962|OTHER||Ratio of GMC|1.59|||||TWO_SIDED|95.0|0.88|2.88|||t-test, 2 sided|||Serotype 6B, Day 1||2.88|0.88|
71000185|NCT03803202|141506962|OTHER||Ratio of GMC|1.01|||||TWO_SIDED|95.0|0.62|1.65|||t-test, 2 sided|||Serotype 7F, Day 1||1.65|0.62|
71000186|NCT03803202|141506962|OTHER||Ratio of GMC|1.58|||||TWO_SIDED|95.0|0.94|2.67|||t-test, 2 sided|||Serotype 7F, Day 1||2.67|0.94|
71000187|NCT03803202|141506962|OTHER||Ratio of GMC|0.9|||||TWO_SIDED|95.0|0.5|1.64|||t-test, 2 sided|||Serotype 7F, Day 1||1.64|0.50|
71000188|NCT03803202|141506962|OTHER||Ratio of GMC|0.79|||||TWO_SIDED|95.0|0.52|1.21|||t-test, 2 sided|||Serotype 9V, Day 1||1.21|0.52|
71000189|NCT03803202|141506962|OTHER||Ratio of GMC|1.57|||||TWO_SIDED|95.0|0.97|2.54|||t-test, 2 sided|||Serotype 9V, Day 1||2.54|0.97|
71042008|NCT03635983|141593450|SUPERIORITY||Odds Ratio (OR)|0.63||||||95.0|0.32|1.24|||||Logistic regression model with treatment, PD-L1 Status and treatment by PD-L1 Status interaction. Responders includes CR+PR|Bempegaldesleukin+Nivolumab vs. Nivolumab (PD-L1 Negative: \<1%)||1.24|0.32|
71000190|NCT03803202|141506962|OTHER||Ratio of GMC|0.99|||||TWO_SIDED|95.0|0.6|1.6|||t-test, 2 sided|||Serotype 9V, Day 1||1.60|0.60|
71000191|NCT03803202|141506962|OTHER||Ratio of GMC|0.73|||||TWO_SIDED|95.0|0.4|1.33|||t-test, 2 sided|||Serotype 14, Day 1||1.33|0.40|
71000192|NCT03803202|141506962|OTHER||Ratio of GMC|1.33|||||TWO_SIDED|95.0|0.73|2.44|||t-test, 2 sided|||Serotype 14, Day 1||2.44|0.73|
71000193|NCT03803202|141506962|OTHER||Ratio of GMC|0.87|||||TWO_SIDED|95.0|0.46|1.63|||t-test, 2 sided|||Serotype 14, Day 1||1.63|0.46|
71000194|NCT03803202|141506962|OTHER||Ratio of GMC|0.69|||||TWO_SIDED|95.0|0.42|1.12|||t-test, 2 sided|||Serotype 18C, Day 1||1.12|0.42|
71042009|NCT03635983|141593450|SUPERIORITY||Odds Ratio (OR)|0.63||||0.9939|TWO_SIDED|95.0|0.39|1.02|||Stratified Cochran-Mantel-Haenszel|Interaction P-value|Logistic regression model with treatment, PD-L1 Status and treatment by PD-L1 Status interaction. Responders includes CR+PR|Bempegaldesleukin+Nivolumab vs. Nivolumab (PD-L1 Positive: \>=1%)||1.02|0.39|0.9939
71042010|NCT03635983|141593451|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.81|1.43|||||Unstratified Hazard Ratio|Bempegaldesleukin+Nivolumab vs. Nivo (PD-L1 negative: \<1%)||1.43|0.81|
71042011|NCT03635983|141593451|SUPERIORITY||Hazard Ratio (HR)|1.12||||||95.0|0.83|1.51|||||Unstratified Hazard Ratio|Bempegaldesleukin+Nivolumab vs. Nivo (PD-L1 positive: \>=1%)||1.51|0.83|
71042012|NCT03635983|141593452|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.66|1.4|||||Unstratified Hazard Ratio|Bempegaldesleukin+Nivolumab vs. Nivo (PD-L1 negative: \<1%)||1.40|0.66|
71042013|NCT03635983|141593452|SUPERIORITY||Hazard Ratio (HR)|0.88||||||95.0|0.58|1.33|||||Unstratified Hazard Ratio|Bempegaldesleukin+Nivolumab vs. Nivo (PD-L1 positive: \>=1%)||1.33|0.58|
71000195|NCT03803202|141506962|OTHER||Ratio of GMC|1.53|||||TWO_SIDED|95.0|0.92|2.55|||t-test, 2 sided|||Serotype 18C, Day 1||2.55|0.92|
71000196|NCT03803202|141506962|OTHER||Ratio of GMC|0.78|||||TWO_SIDED|95.0|0.44|1.37|||t-test, 2 sided|||Serotype 18C, Day 1||1.37|0.44|
71000197|NCT03803202|141506962|OTHER||Ratio of GMC|0.82|||||TWO_SIDED|95.0|0.54|1.25|||t-test, 2 sided|||Serotype 19A, Day 1||1.25|0.54|
71000198|NCT03803202|141506962|OTHER||Ratio of GMC|1.34|||||TWO_SIDED|95.0|0.84|2.12|||t-test, 2 sided|||Serotype 19A, Day 1||2.12|0.84|
71042014|NCT01235442|141593465|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05|||<|0.001|TWO_SIDED|95.0|1.46|2.87||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is stratified by baseline BMI(=\<35 or \>35) and prior anti-TNF exposure(Yes or no).||||2.87|1.46|<0.001
71042015|NCT01235442|141593466|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96|||<|0.001|TWO_SIDED|95.0|1.4|2.75||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is stratified by baseline BMI (=\<35 or \>35) and prior anti-TNF exposure (Yes or No).||||2.75|1.40|<0.001
71000199|NCT03803202|141506962|OTHER||Ratio of GMC|1.05|||||TWO_SIDED|95.0|0.66|1.66|||t-test, 2 sided|||Serotype 19A, Day 1||1.66|0.66|
71000200|NCT03803202|141506962|OTHER||Ratio of GMC|0.83|||||TWO_SIDED|95.0|0.51|1.37|||t-test, 2 sided|||Serotype 19F, Day 1||1.37|0.51|
71000201|NCT03803202|141506962|OTHER||Ratio of GMC|1.26|||||TWO_SIDED|95.0|0.75|2.11|||t-test, 2 sided|||Serotype 19F, Day 1||2.11|0.75|
71000202|NCT03803202|141506962|OTHER||Ratio of GMC|0.99|||||TWO_SIDED|95.0|0.57|1.72|||t-test, 2 sided|||Serotype 19F, Day 1||1.72|0.57|
71000203|NCT03803202|141506962|OTHER||Ratio of GMC|1.08|||||TWO_SIDED|95.0|0.63|1.86|||t-test, 2 sided|||Serotype 23F, Day 1||1.86|0.63|
71000204|NCT03803202|141506962|OTHER||Ratio of GMC|1.19|||||TWO_SIDED|95.0|0.69|2.08|||t-test, 2 sided|||Serotype 23F, Day 1||2.08|0.69|
71000205|NCT03803202|141506962|OTHER||Ratio of GMC|1.19|||||TWO_SIDED|95.0|0.67|2.14|||t-test, 2 sided|||Serotype 23F, Day 1||2.14|0.67|
71000206|NCT03803202|141506962|OTHER||Ratio of GMC|0.82|||||TWO_SIDED|95.0|0.52|1.29|||t-test, 2 sided|||Serotype 1, Day 30||1.29|0.52|
71000207|NCT03803202|141506962|OTHER||Ratio of GMC|1.04|||||TWO_SIDED|95.0|0.68|1.59|||t-test, 2 sided|||Serotype 1, Day 30||1.59|0.68|
71000208|NCT03803202|141506962|OTHER||Ratio of GMC|1.17|||||TWO_SIDED|95.0|0.76|1.8|||t-test, 2 sided|||Serotype 1, Day 30||1.80|0.76|
71000209|NCT03803202|141506962|OTHER||Ratio of GMC|2.07|||||TWO_SIDED|95.0|1.42|3.01|||t-test, 2 sided|||Serotype 3, Day 30||3.01|1.42|
71000210|NCT03803202|141506962|OTHER||Ratio of GMC|3.29|||||TWO_SIDED|95.0|2.37|4.58|||t-test, 2 sided|||Serotype 3, Day 30||4.58|2.37|
71000211|NCT03803202|141506962|OTHER||Ratio of GMC|4.05|||||TWO_SIDED|95.0|2.83|5.79|||t-test, 2 sided|||Serotype 3, Day 30||5.79|2.83|
71042016|NCT01235442|141593467|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.78||||0.009|TWO_SIDED|95.0|1.21|2.64||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is stratified by baseline BMI (=\<35 or \>35) and prior anti-TNF exposure (Yes or No).||||2.64|1.21|0.009
71042017|NCT01235442|141593468|SUPERIORITY_OR_OTHER|||||||0.006||||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is stratified by baseline BMI (=\<35 or \>35) and prior anti-TNF exposure (Yes or No) with with modified ridit scores.||||||0.006
71042018|NCT01235442|141593469|SUPERIORITY_OR_OTHER||||||<|0.001||||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|van Elteren test|The test is stratified by baseline BMI (=\<35 or \>35) and prior anti-TNF exposure (Yes or No).||||||<0.001
71042019|NCT01235442|141593470|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.135|TWO_SIDED|95.0|0.92|1.85||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is adjusted for baseline BMI (=\<35 or \>35) and prior anti-TNF (Yes or No).||||1.85|0.92|0.135
71042020|NCT01235442|141593471|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.135|TWO_SIDED|95.0|0.96|1.87||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is stratified by baseline BMI (=\<35 or \>35) and prior anti-TNF exposure (Yes or No).||||1.87|0.96|0.135
70923969|NCT00812461|141340012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.11||0.029|TWO_SIDED|95.0|-0.44|-0.02|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 225 participants in the placebo group and 203 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model; an unstructured covariance matrix was used.||-0.02|-0.44|0.029
71000212|NCT03803202|141506962|OTHER||Ratio of GMC|0.79|||||TWO_SIDED|95.0|0.49|1.27|||t-test, 2 sided|||Serotype 4, Day 30||1.27|0.49|
71000213|NCT03803202|141506962|OTHER||Ratio of GMC|0.97|||||TWO_SIDED|95.0|0.63|1.48|||t-test, 2 sided|||Serotype 4, Day 30||1.48|0.63|
71000214|NCT03803202|141506962|OTHER||Ratio of GMC|1.05|||||TWO_SIDED|95.0|0.66|1.65|||t-test, 2 sided|||Serotype 4, Day 30||1.65|0.66|
71000215|NCT03803202|141506962|OTHER||Ratio of GMC|1.31|||||TWO_SIDED|95.0|0.75|2.29|||t-test, 2 sided|||Serotype 5, Day 30||2.29|0.75|
71000216|NCT03803202|141506962|OTHER||Ratio of GMC|1.3|||||TWO_SIDED|95.0|0.77|2.19|||t-test, 2 sided|||Serotype 5, Day 30||2.19|0.77|
71000217|NCT03803202|141506962|OTHER||Ratio of GMC|1.91|||||TWO_SIDED|95.0|1.08|3.37|||t-test, 2 sided|||Serotype 5, Day 30||3.37|1.08|
71000218|NCT03803202|141506962|OTHER||Ratio of GMC|0.86|||||TWO_SIDED|95.0|0.5|1.49|||t-test, 2 sided|||Serotype 6A, Day 30||1.49|0.50|
71000219|NCT03803202|141506962|OTHER||Ratio of GMC|1.06|||||TWO_SIDED|95.0|0.65|1.72|||t-test, 2 sided|||Serotype 6A, Day 30||1.72|0.65|
71000220|NCT03803202|141506962|OTHER||Ratio of GMC|1.22|||||TWO_SIDED|95.0|0.71|2.1|||t-test, 2 sided|||Serotype 6A, Day 30||2.10|0.71|
71000221|NCT03803202|141506962|OTHER||Ratio of GMC|0.99|||||TWO_SIDED|95.0|0.56|1.75|||t-test, 2 sided|||Serotype 6B, Day 30||1.75|0.56|
71000222|NCT03803202|141506962|OTHER||Ratio of GMC|1.44|||||TWO_SIDED|95.0|0.84|2.47|||t-test, 2 sided|||Serotype 6B, Day 30||2.47|0.84|
71000223|NCT03803202|141506962|OTHER||Ratio of GMC|1.77|||||TWO_SIDED|95.0|1.0|3.15|||t-test, 2 sided|||Serotype 6B, Day 30||3.15|1.00|
71000224|NCT03803202|141506962|OTHER||Ratio of GMC|1.54|||||TWO_SIDED|95.0|1.02|2.3|||t-test, 2 sided|||Serotype 7F, Day 30||2.30|1.02|
71042021|NCT02412722|141593492|SUPERIORITY||Geometric Mean Ratio|0.59|||||TWO_SIDED|90.0|0.46|0.76||||||||0.76|0.46|
71042022|NCT02412722|141593493|SUPERIORITY||Geometric Mean Ratio|0.9|||||TWO_SIDED|90.0|0.59|1.36||||||||1.36|0.59|
71042023|NCT02412722|141593494|SUPERIORITY||Geometric Mean Ratio|1.04|||||TWO_SIDED|90.0|0.72|1.49||||||||1.49|0.72|
71042024|NCT02412722|141593498|SUPERIORITY||Geometric Mean Ratio|1.07|||||TWO_SIDED|90.0|0.78|1.47||||||||1.47|0.78|
71100523|NCT02732145|141709674|EQUIVALENCE|Question: Is there a difference in the incidence of aching of the vulva among the patients with vulvar discomfort?||||||0.0001|||||||Chi-squared|||Parameter: The difference in the incidence of aching of the vulva among patients with vulvar discomfort.||||0.0001
71100524|NCT02732145|141709674|EQUIVALENCE|Question: Is there a difference in the association of different symptoms of the vulva among the patients with vulvar discomfort?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of association of different vulvar symptoms among patients with vulvar discomfort.||||0.0000
71000225|NCT03803202|141506962|OTHER||Ratio of GMC|1.55|||||TWO_SIDED|95.0|1.06|2.26|||t-test, 2 sided|||Serotype 7F, Day 30||2.26|1.06|
71100525|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus burning in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus burning in patients with vulvar dermatosis.||||0.0000
71100526|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus stinging in the patients with vulvar dermatosis?||||||0.0008|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus stinging in patients with vulvar dermatosis.||||0.0008
71000226|NCT03803202|141506962|OTHER||Ratio of GMC|1.66|||||TWO_SIDED|95.0|1.09|2.53|||t-test, 2 sided|||Serotype 7F, Day 30||2.53|1.09|
71000227|NCT03803202|141506962|OTHER||Ratio of GMC|1.29|||||TWO_SIDED|95.0|0.81|2.07|||t-test, 2 sided|||Serotype 9V, Day 30||2.07|0.81|
71000228|NCT03803202|141506962|OTHER||Ratio of GMC|1.64|||||TWO_SIDED|95.0|1.04|2.57|||t-test, 2 sided|||Serotype 9V, Day 30||2.57|1.04|
71000229|NCT03803202|141506962|OTHER||Ratio of GMC|2.16|||||TWO_SIDED|95.0|1.35|3.47|||t-test, 2 sided|||Serotype 9V, Day 30||3.47|1.35|
71000230|NCT03803202|141506962|OTHER||Ratio of GMC|0.99|||||TWO_SIDED|95.0|0.58|1.68|||t-test, 2 sided|||Serotype 14, Day 30||1.68|0.58|
71000231|NCT03803202|141506962|OTHER||Ratio of GMC|1.26|||||TWO_SIDED|95.0|0.77|2.05|||t-test, 2 sided|||Serotype 14, Day 30||2.05|0.77|
71000232|NCT03803202|141506962|OTHER||Ratio of GMC|1.67|||||TWO_SIDED|95.0|0.99|2.81|||t-test, 2 sided|||Serotype 14, Day 30||2.81|0.99|
71000233|NCT03803202|141506962|OTHER||Ratio of GMC|0.61|||||TWO_SIDED|95.0|0.39|0.95|||t-test, 2 sided|||Serotype 18C, Day 30||0.95|0.39|
71000234|NCT03803202|141506962|OTHER||Ratio of GMC|1.04|||||TWO_SIDED|95.0|0.7|1.54|||t-test, 2 sided|||Serotype 18C, Day 30||1.54|0.70|
71000235|NCT03803202|141506962|OTHER||Ratio of GMC|1.03|||||TWO_SIDED|95.0|0.67|1.57|||t-test, 2 sided|||Serotype 18C, Day 30||1.57|0.67|
71000236|NCT03803202|141506962|OTHER||Ratio of GMC|0.83|||||TWO_SIDED|95.0|0.56|1.25|||t-test, 2 sided|||Serotype 19A, Day 30||1.25|0.56|
71000237|NCT03803202|141506962|OTHER||Ratio of GMC|1.07|||||TWO_SIDED|95.0|0.75|1.52|||t-test, 2 sided|||Serotype 19A, Day 30||1.52|0.75|
71042025|NCT02412722|141593499|SUPERIORITY||Geometric Mean Ratio|1.12|||||TWO_SIDED|90.0|0.75|1.68||||||||1.68|0.75|
71042026|NCT02412722|141593500|SUPERIORITY||Geometric Mean Ratio|0.92|||||TWO_SIDED|90.0|0.67|1.26||||||||1.26|0.67|
71042027|NCT01263561|141593534|NON_INFERIORITY_OR_EQUIVALENCE|A sample size calculation determined that 52 eyes were required to detect a 2.0 mmHg IOP difference with a power of 80%.||||||0.85|TWO_SIDED||||||t-test, 2 sided|||||||.85
71042028|NCT01263561|141593535|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation only for main outcome measure of IOP.||||||0.24|TWO_SIDED||||||Kaplan Meier|||||||.24
71042029|NCT01263561|141593536|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation only performed for main outcome measure of IOP.||||||0.8|TWO_SIDED|||||Above p is for number of subjects with any complication. P values above 0.05 are considered statistically insignificant in this study.|Chi-squared|||||||0.80
71100527|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus soreness in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus soreness in patients with vulvar dermatosis.||||0.0000
71000238|NCT03803202|141506962|OTHER||Ratio of GMC|1.2|||||TWO_SIDED|95.0|0.77|1.86|||t-test, 2 sided|||Serotype 19A, Day 30||1.86|0.77|
71000239|NCT03803202|141506962|OTHER||Ratio of GMC|1.2|||||TWO_SIDED|95.0|0.76|1.9|||t-test, 2 sided|||Serotype 19F, Day 30||1.90|0.76|
71000240|NCT03803202|141506962|OTHER||Ratio of GMC|1.69|||||TWO_SIDED|95.0|1.11|2.58|||t-test, 2 sided|||Serotype 19F, Day 30||2.58|1.11|
71000241|NCT03803202|141506962|OTHER||Ratio of GMC|2.23|||||TWO_SIDED|95.0|1.41|3.52|||t-test, 2 sided|||Serotype 19F, Day 30||3.52|1.41|
71000242|NCT03803202|141506962|OTHER||Ratio of GMC|0.86|||||TWO_SIDED|95.0|0.5|1.47|||t-test, 2 sided|||Serotype 23F, Day 30||1.47|0.50|
71000243|NCT03803202|141506962|OTHER||Ratio of GMC|0.83|||||TWO_SIDED|95.0|0.51|1.35|||t-test, 2 sided|||Serotype 23F, Day 30||1.35|0.51|
71000244|NCT03803202|141506962|OTHER||Ratio of GMC|1.18|||||TWO_SIDED|95.0|0.69|2.02|||t-test, 2 sided|||Serotype 23F, Day 30||2.02|0.69|
71000245|NCT03803202|141506965|OTHER||Mean Difference|0.1||||0.805|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||Serotype 1, Day 30||0.5|-0.4|0.805
71042030|NCT01396421|141593537|SUPERIORITY_OR_OTHER||Treatment difference|-8.18|||<|0.0001|TWO_SIDED|95.0|-12.0|-4.4||Primary analysis was performed by fitting a Mixed Model Repeated Measures (MMRM) which included fixed class effect terms for treatment, trial site, visit week, and an interaction term of treatment by visit week.|Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||Difference between average effect of brexpiprazole 2 and 4 mg/day and placebo was tested first at alpha level of 0.05. If statistically significant, then comparisons for each group (brexpiprazole 2 and 4 mg/day) versus placebo were performed.||-4.40|-12.0|<0.0001
71042031|NCT01396421|141593537|SUPERIORITY_OR_OTHER||Treatment difference|-7.64||||0.0006|TWO_SIDED|95.0|-12.0|-3.3|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||Sample size was determined to achieve 90% power at alpha level of 0.025 (two-sided) to a detect treatment difference of -7.5 points in change from baseline in PANSS Total Score at Week 6 (last observation carried forward) between a brexpiprazole treatment of 4 mg/day (or 2 mg/day) and placebo using a two-sided z-test||-3.30|-12.0|0.0006
71042032|NCT01396421|141593537|SUPERIORITY_OR_OTHER||Traetment difference|-8.72|||<|0.0001|TWO_SIDED|95.0|-13.1|-4.37|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||Sample size was determined to achieve 90% power at alpha level of 0.025 (two-sided) to a detect treatment difference of -7.5 points in change from baseline in PANSS Total Score at Week 6 (last observation carried forward) between a brexpiprazole treatment of 4 mg/day (or 2 mg/day) and placebo using a two-sided z-test||-4.37|-13.1|<0.0001
71100528|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus irritation in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus irritation in patients with vulvar dermatosis.||||0.0000
71000246|NCT03803202|141506965|OTHER||Mean Difference|0.4||||0.102|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 1, Day 30||0.9|-0.1|0.102
71000247|NCT03803202|141506965|OTHER||Mean Difference|0.4||||0.158|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 1, Day 30||0.9|-0.1|0.158
71000248|NCT03803202|141506965|OTHER||Mean Difference|-0.1||||0.596|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||Serotype 2, Day 30||0.2|-0.4|0.596
71000249|NCT03803202|141506965|OTHER||Mean Difference|0.3||||0.025|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Serotype 2, Day 30||0.7|0.0|0.025
71000250|NCT03803202|141506965|OTHER||Mean Difference|0.4||||0.005|TWO_SIDED|95.0|0.1|0.7|||ANCOVA|||Serotype 2, Day 30||0.7|0.1|0.005
71000251|NCT03803202|141506965|OTHER||Mean Difference|0.3||||0.037|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Serotype 3, Day 30||0.7|0.0|0.037
71000252|NCT03803202|141506965|OTHER||Mean Difference|0.6||||0.002|TWO_SIDED|95.0|0.2|0.9|||ANCOVA|||Serotype 3, Day 30||0.9|0.2|0.002
71000253|NCT03803202|141506965|OTHER||Mean Difference|0.2||||0.23|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 3, Day 30||0.6|-0.1|0.230
71000254|NCT03803202|141506965|OTHER||Mean Difference|0.0||||0.984|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Serotype 4, Day 30||0.4|-0.4|0.984
71000255|NCT03803202|141506965|OTHER||Mean Difference|0.2||||0.262|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 4, Day 30||0.6|-0.2|0.262
71000256|NCT03803202|141506965|OTHER||Mean Difference|0.2||||0.264|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 4, Day 30||0.6|-0.2|0.264
71000257|NCT03803202|141506965|OTHER||Mean Difference|0.1||||0.638|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||Serotype 5, Day 30||0.6|-0.4|0.638
71000258|NCT03803202|141506965|OTHER||Mean Difference|0.5||||0.036|TWO_SIDED|95.0|0.0|1.0|||ANCOVA|||Serotype 5, Day 30||1.0|0.0|0.036
71000259|NCT03803202|141506965|OTHER||Mean Difference|0.4||||0.094|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 5, Day 30||0.9|-0.1|0.094
71000260|NCT03803202|141506965|OTHER||Mean Difference|0.3||||0.266|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|||Serotype 6A, Day 30||0.8|-0.2|0.266
71000261|NCT03803202|141506965|OTHER||Mean Difference|0.3||||0.25|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|||Serotype 6A, Day 30||0.8|-0.2|0.250
71100529|NCT02732145|141709674|SUPERIORITY|||||||0||||||There was a statistically significant difference at p\<0.001. Patients with vulvar dermatosis had significantly more often itching than the feeling of inflammation of the vulva.|t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus the feeling of inflammation in patients with vulvar dermatosis.||||0.0000
71100530|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus aching in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus aching in patients with vulvar dermatosis.||||0.0000
71100531|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus burning in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus burning in patients with vulvar dermatosis.||||0.0000
71100532|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus soreness in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus soreness in patients with vulvar dermatosis.||||0.0000
71100533|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus irritation in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus irritation in patients with vulvar dermatosis.||||0.0000
71100534|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus the feeling of inflammation in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus the feeling of inflammation in patients with vulvar dermatosis.||||0.0000
71100535|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus aching in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus aching in patients with vulvar dermatosis.||||0.0000
71100536|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus burning in the patients with vulvar dermatosis?||||||0.8591|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus burning in patients with vulvar dermatosis.||||0.8591
71100537|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus soreness in the patients with vulvar dermatosis?||||||0.009|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus soreness in patients with vulvar dermatosis.||||0.0090
71100538|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus irritation in the patients with vulvar dermatosis?||||||0.0212|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus irritation in patients with vulvar dermatosis.||||0.0212
71000262|NCT03803202|141506965|OTHER||Mean Difference|0.0||||0.927|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Serotype 6A, Day 30||0.5|-0.5|0.927
71000263|NCT03803202|141506965|OTHER||Mean Difference|-0.1||||0.679|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Serotype 6B, Day 30||0.3|-0.5|0.679
71000264|NCT03803202|141506965|OTHER||Mean Difference|-0.1||||0.589|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||Serotype 6B, Day 30||0.3|-0.6|0.589
71000265|NCT03803202|141506965|OTHER||Mean Difference|0.0||||0.88|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|||Serotype 6B, Day 30||0.4|-0.5|0.880
71000266|NCT03803202|141506965|OTHER||Mean Difference|0.1||||0.623|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|||Serotype 7F, Day 30||0.4|-0.2|0.623
71000267|NCT03803202|141506965|OTHER||Mean Difference|0.2||||0.232|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 7F, Day 30||0.6|-0.1|0.232
71000268|NCT03803202|141506965|OTHER||Mean Difference|0.1||||0.451|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Serotype 7F, Day 30||0.5|-0.2|0.451
71000269|NCT03803202|141506965|OTHER||Mean Difference|0.0||||0.785|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 8, Day 30||0.4|-0.3|0.785
71000270|NCT03803202|141506965|OTHER||Mean Difference|0.8|||<|0.001|TWO_SIDED|95.0|0.4|1.1|||ANCOVA|||Serotype 8, Day 30||1.1|0.4|<.001
71000271|NCT03803202|141506965|OTHER||Mean Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.4|1.1|||ANCOVA|||Serotype 8, Day 30||1.1|0.4|<.001
71000272|NCT03803202|141506965|OTHER||Mean Difference|0.2||||0.146|TWO_SIDED|95.0|-0.1|0.5|||ANCOVA|||Serotype 9N, Day 30||0.5|-0.1|0.146
71000273|NCT03803202|141506965|OTHER||Mean Difference|0.5||||0.003|TWO_SIDED|95.0|0.2|0.8|||ANCOVA|||Serotype 9N, Day 30||0.8|0.2|0.003
71000274|NCT03803202|141506965|OTHER||Mean Difference|0.3||||0.113|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 9N, Day 30||0.6|-0.1|0.113
71000275|NCT03803202|141506965|OTHER||Mean Difference|-0.2||||0.453|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||Serotype 9V, Day 30||0.3|-0.6|0.453
71000276|NCT03803202|141506965|OTHER||Mean Difference|0.4||||0.111|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 9V, Day 30||0.8|-0.1|0.111
71000277|NCT03803202|141506965|OTHER||Mean Difference|0.5||||0.02|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|||Serotype 9V, Day 30||1.0|0.1|0.020
71000278|NCT03803202|141506965|OTHER||Mean Difference|0.3||||0.218|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|||Serotype 10A, Day 30||0.8|-0.2|0.218
71000279|NCT03803202|141506965|OTHER||Mean Difference|0.4||||0.125|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 10A, Day 30||0.9|-0.1|0.125
71000280|NCT03803202|141506965|OTHER||Mean Difference|0.1||||0.706|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||Serotype 10A, Day 30||0.6|-0.4|0.706
71000281|NCT03803202|141506965|OTHER||Mean Difference|0.2||||0.246|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 11A, Day 30||0.6|-0.1|0.246
71000282|NCT03803202|141506965|OTHER||Mean Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.3|1.1|||ANCOVA|||Serotype 11A, Day 30||1.1|0.3|<.001
71000283|NCT03803202|141506965|OTHER||Mean Difference|0.5||||0.01|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Serotype 11A, Day 30||0.9|0.1|0.010
71000284|NCT03803202|141506965|OTHER||Mean Difference|-0.3||||0.26|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||Serotype 12F, Day 30||0.2|-0.7|0.260
71000285|NCT03803202|141506965|OTHER||Mean Difference|0.2||||0.366|TWO_SIDED|95.0|-0.3|0.7|||ANCOVA|||Serotype 12F, Day 30||0.7|-0.3|0.366
71000286|NCT03803202|141506965|OTHER||Mean Difference|0.5||||0.046|TWO_SIDED|95.0|0.0|1.0|||ANCOVA|||Serotype 12F, Day 30||1.0|0.0|0.046
71000287|NCT03803202|141506965|OTHER||Mean Difference|-0.4||||0.101|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||Serotype 14, Day 30||0.1|-0.8|0.101
71000288|NCT03803202|141506965|OTHER||Mean Difference|0.2||||0.522||95.0|-0.3|0.6|||ANCOVA|||Serotype 14, Day 30||0.6|-0.3|0.522
71000289|NCT03803202|141506965|OTHER||Mean Difference|0.5||||0.026|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|||Serotype 14, Day 30||1.0|0.1|0.026
71000290|NCT03803202|141506965|OTHER||Mean Difference|-0.2||||0.236|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Serotype 15B, Day 30||0.2|-0.6|0.236
71000291|NCT03803202|141506965|OTHER||Mean Difference|0.1||||0.528|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Serotype 15B, Day 30||0.5|-0.3|0.528
71042033|NCT01396421|141593537|SUPERIORITY_OR_OTHER||Treatment difference|-2.89||||0.291|TWO_SIDED|95.0|-8.27|2.49|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||Sample size was determined to achieve 90% power at alpha level of 0.025 (two-sided) to a detect treatment difference of -7.5 points in change from baseline in PANSS Total Score at Week 6 (last observation carried forward) between a brexpiprazole treatment of 4 mg/day (or 2 mg/day) and placebo using a two-sided z-test||2.49|-8.27|0.2910
71042034|NCT01396421|141593538|SUPERIORITY_OR_OTHER||Treatment difference|-0.36||||0.0006|TWO_SIDED|95.0|-0.56|-0.15|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||Difference between the average effect of brexpiprazole 2 and 4 mg/day and placebo was tested first at alpha level of 0.05. If statistically significant, then comparisons for each group (brexpiprazole 2 and 4 mg/day) versus placebo were performed at a significance level of 0.05.||-0.15|-0.56|0.0006
71000292|NCT03803202|141506965|OTHER||Mean Difference|0.4||||0.081|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||Serotype 15B, Day 30||0.8|0.0|0.081
71000293|NCT03803202|141506965|OTHER||Mean Difference|-0.1||||0.388|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Serotype 17F, Day 30||0.2|-0.5|0.388
71000294|NCT03803202|141506965|OTHER||Mean Difference|0.3||||0.151|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 17F, Day 30||0.6|-0.1|0.151
71000295|NCT03803202|141506965|OTHER||Mean Difference|0.4||||0.024|TWO_SIDED|95.0|0.1|0.7|||ANCOVA|||Serotype 17F, Day 30||0.7|0.1|0.024
71000296|NCT03803202|141506965|OTHER||Mean Difference|0.1||||0.476|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Serotype 18C, Day 30||0.5|-0.3|0.476
71000297|NCT03803202|141506965|OTHER||Mean Difference|0.4||||0.077|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||Serotype 18C, Day 30||0.8|0.0|0.077
71000298|NCT03803202|141506965|OTHER||Mean Difference|0.2||||0.262|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 18C, Day 30||0.6|-0.2|0.262
71042035|NCT01396421|141593538|SUPERIORITY_OR_OTHER||Treatment difference|-0.38||||0.0012|TWO_SIDED|95.0|-0.61|-0.15|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||||-0.15|-0.61|0.0012
71042036|NCT01396421|141593538|SUPERIORITY_OR_OTHER||Treatment difference|-0.33||||0.0056|TWO_SIDED|95.0|-0.56|-0.1|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||||-0.10|-0.56|0.0056
71000299|NCT03803202|141506965|OTHER||Mean Difference|0.0||||0.767|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 19A, Day 30||0.4|-0.3|0.767
71000300|NCT03803202|141506965|OTHER||Mean Difference|0.2||||0.364|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Serotype 19A, Day 30||0.5|-0.2|0.364
71000301|NCT03803202|141506965|OTHER||Mean Difference|0.1||||0.522|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Serotype 19A, Day 30||0.5|-0.2|0.522
71000302|NCT03803202|141506965|OTHER||Mean Difference|0.0||||0.962|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Serotype 19F, Day 30||0.4|-0.4|0.962
71000303|NCT03803202|141506965|OTHER||Mean Difference|0.3||||0.091|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 19F, Day 30||0.7|-0.1|0.091
71000304|NCT03803202|141506965|OTHER||Mean Difference|0.3||||0.093|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 19F, Day 30||0.7|-0.1|0.093
71000305|NCT03803202|141506965|OTHER||Mean Difference|-0.2||||0.455|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||Serotype 20B, Day 30||0.3|-0.6|0.455
71000306|NCT03803202|141506965|OTHER||Mean Difference|0.4||||0.093|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 20B, Day 30||0.9|-0.1|0.093
71000307|NCT03803202|141506965|OTHER||Mean Difference|0.6||||0.017|TWO_SIDED|95.0|0.1|1.1|||ANCOVA|||Serotype 20B, Day 30||1.1|0.1|0.017
71000308|NCT03803202|141506965|OTHER||Mean Difference|-0.1||||0.561|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Serotype 22F, Day 30||0.3|-0.5|0.561
71000309|NCT03803202|141506965|OTHER||Mean Difference|0.2||||0.343|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 22F, Day 30||0.6|-0.2|0.343
71000310|NCT03803202|141506965|OTHER||Mean Difference|0.3||||0.132|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 22F, Day 30||0.7|-0.1|0.132
71000311|NCT03803202|141506965|OTHER||Mean Difference|0.0||||0.898|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||Serotype 23F, Day 30||0.6|-0.5|0.898
71000312|NCT03803202|141506965|OTHER||Mean Difference|0.3||||0.313|TWO_SIDED|95.0|-0.3|0.9|||ANCOVA|||Serotype 23F, Day 30||0.9|-0.3|0.313
71000313|NCT03803202|141506965|OTHER||Mean Difference|0.3||||0.366|TWO_SIDED|95.0|-0.3|0.8|||ANCOVA|||Serotype 23F, Day 30||0.8|-0.3|0.366
71000314|NCT03803202|141506965|OTHER||Mean Difference|0.0||||0.961|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Serotype 33F, Day 30||0.4|-0.4|0.961
71000315|NCT03803202|141506965|OTHER||Mean Difference|0.2||||0.269|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 33F, Day 30||0.6|-0.2|0.269
71000316|NCT03803202|141506965|OTHER||Mean Difference|0.2||||0.245|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 33F, Day 30||0.6|-0.2|0.245
71000317|NCT03803202|141506966|OTHER||Mean Difference|0.3||||0.213|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 1, Day 30||0.7|-0.1|0.213
71000318|NCT03803202|141506966|OTHER||Mean Difference|0.4||||0.097|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 1, Day 30||0.8|-0.1|0.097
71000319|NCT03803202|141506966|OTHER||Mean Difference|0.1||||0.631|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Serotype 1, Day 30||0.5|-0.3|0.631
71000320|NCT03803202|141506966|OTHER||Mean Difference|0.1||||0.699|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 2, Day 30||0.4|-0.3|0.699
71000321|NCT03803202|141506966|OTHER||Mean Difference|0.4||||0.042|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Serotype 2, Day 30||0.7|0.0|0.042
71000322|NCT03803202|141506966|OTHER||Mean Difference|0.3||||0.092|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 2, Day 30||0.7|-0.1|0.092
71042037|NCT01396421|141593538|SUPERIORITY_OR_OTHER||Treatment difference|-0.03||||0.8491|TWO_SIDED|95.0|-0.31|0.26|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||||0.26|-0.31|0.8491
71042038|NCT01396421|141593539|SUPERIORITY_OR_OTHER||Treatment difference|-1.5||||0.0644|TWO_SIDED|95.0|-3.09|0.09||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, and baseline visit interaction as covariates.|Mixed Models Analysis|Week 1||||0.09|-3.09|0.0644
71000323|NCT03803202|141506966|OTHER||Mean Difference|0.5||||0.007|TWO_SIDED|95.0|0.1|0.8|||ANCOVA|||Serotype 3, Day 30||0.8|0.1|0.007
71000324|NCT03803202|141506966|OTHER||Mean Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.3|1.0|||ANCOVA|||Serotype 3, Day 30||1.0|0.3|<.001
71042039|NCT01396421|141593539|SUPERIORITY_OR_OTHER||Treatment difference|-1.99||||0.0139|TWO_SIDED|95.0|-3.58|-0.41||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 1||||-0.41|-3.58|0.0139
71042040|NCT01396421|141593539|SUPERIORITY_OR_OTHER||Treatment difference|0.35||||0.7231|TWO_SIDED|95.0|-1.61|2.32||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 1||||2.32|-1.61|0.7231
71042041|NCT01396421|141593539|SUPERIORITY_OR_OTHER||Treatment difference|-5.14||||0.0018|TWO_SIDED|95.0|-8.36|-1.93||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3||||-1.93|-8.36|0.0018
71000325|NCT03803202|141506966|OTHER||Mean Difference|0.2||||0.237|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 3, Day 30||0.6|-0.1|0.237
71000326|NCT03803202|141506966|OTHER||Mean Difference|0.2||||0.248|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 4, Day 30||0.6|-0.2|0.248
71000327|NCT03803202|141506966|OTHER||Mean Difference|0.3||||0.193|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 4, Day 30||0.7|-0.1|0.193
71000328|NCT03803202|141506966|OTHER||Mean Difference|0.0||||0.838|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||Serotype 4, Day 30||0.5|-0.4|0.838
71000329|NCT03803202|141506966|OTHER||Mean Difference|0.0||||0.898|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|||Serotype 5, Day 30||0.4|-0.5|0.898
71000330|NCT03803202|141506966|OTHER||Mean Difference|0.4||||0.143|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 5, Day 30||0.9|-0.1|0.143
71000331|NCT03803202|141506966|OTHER||Mean Difference|0.4||||0.108|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 5, Day 30||0.9|-0.1|0.108
71000332|NCT03803202|141506966|OTHER||Mean Difference|0.2||||0.396|TWO_SIDED|95.0|-0.3|0.7|||ANCOVA|||Serotype 6A, Day 30||0.7|-0.3|0.396
71000333|NCT03803202|141506966|OTHER||Mean Difference|0.3||||0.182|TWO_SIDED|95.0|-0.2|0.9|||ANCOVA|||Serotype 6A, Day 30||0.9|-0.2|0.182
71000334|NCT03803202|141506966|OTHER||Mean Difference|0.1||||0.593|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||Serotype 6A, Day 30||0.6|-0.4|0.593
71000335|NCT03803202|141506966|OTHER||Mean Difference|0.4||||0.186|TWO_SIDED|95.0|-0.2|0.9|||ANCOVA|||Serotype 6B, Day 30||0.9|-0.2|0.186
71000336|NCT03803202|141506966|OTHER||Mean Difference|0.6||||0.038|TWO_SIDED|95.0|0.0|1.1|||ANCOVA|||Serotype 6B, Day 30||1.1|0.0|0.038
71000337|NCT03803202|141506966|OTHER||Mean Difference|0.2||||0.408|TWO_SIDED|95.0|-0.3|0.8|||ANCOVA|||Serotype 6B, Day 30||0.8|-0.3|0.408
71000338|NCT03803202|141506966|OTHER||Mean Difference|0.1||||0.805|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 7F, Day 30||0.4|-0.3|0.805
71000339|NCT03803202|141506966|OTHER||Mean Difference|0.1||||0.711|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Serotype 7F, Day 30||0.5|-0.3|0.711
71000340|NCT03803202|141506966|OTHER||Mean Difference|0.0||||0.891|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Serotype 7F, Day 30||0.4|-0.4|0.891
71000341|NCT03803202|141506966|OTHER||Mean Difference|0.1||||0.649|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 8, Day 30||0.4|-0.3|0.649
71000342|NCT03803202|141506966|OTHER||Mean Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.3|1.0|||ANCOVA|||Serotype 8, Day 30||1.0|0.3|<.001
71000343|NCT03803202|141506966|OTHER||Mean Difference|0.6|||<|0.001|TWO_SIDED|95.0|0.3|0.9|||ANCOVA|||Serotype 8, Day 30||0.9|0.3|<.001
71000344|NCT03803202|141506966|OTHER||Mean Difference|0.2||||0.454|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Serotype 9N, Day 30||0.5|-0.2|0.454
71000345|NCT03803202|141506966|OTHER||Mean Difference|0.6||||0.003|TWO_SIDED|95.0|0.2|1.0|||ANCOVA|||Serotype 9N, Day 30||1.0|0.2|0.003
71000346|NCT03803202|141506966|OTHER||Mean Difference|0.5||||0.021|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Serotype 9N, Day 30||0.9|0.1|0.021
71000347|NCT03803202|141506966|OTHER||Mean Difference|0.3||||0.205|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 9V, Day 30||0.6|-0.1|0.205
71000348|NCT03803202|141506966|OTHER||Mean Difference|0.5||||0.015|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Serotype 9V, Day 30||0.9|0.1|0.015
71000349|NCT03803202|141506966|OTHER||Mean Difference|0.3||||0.209|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 9V, Day 30||0.7|-0.1|0.209
71042042|NCT01396421|141593539|SUPERIORITY_OR_OTHER||Treatment difference|-3.75||||0.0045|TWO_SIDED|95.0|-6.33|-1.17||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates|Mixed Models Analysis|Week 2||||-1.17|-6.33|0.0045
71042043|NCT01396421|141593539|SUPERIORITY_OR_OTHER||Treatment difference|1.84||||0.2568|TWO_SIDED|95.0|-1.34|5.02||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 2||||5.02|-1.34|0.2568
71042044|NCT01396421|141593539|SUPERIORITY_OR_OTHER||Treatment difference|-4.4||||0.0009|TWO_SIDED|95.0|-6.97|-1.82||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 2||||-1.82|-6.97|0.0009
71100539|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus the feeling of inflammation in the patients with vulvar dermatosis?||||||0.0057|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus the feeling of inflammation in patients with vulvar dermatosis.||||0.0057
71100540|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar sticking versus knife-like pain in the patients with vulvar dermatosis who had sharp pain?||||||0.0977|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus knife-like pain in patients with vulvar dermatosis who had sharp vulvar pain.||||0.0977
71100541|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar sticking versus paper-cuts pain in the patients with vulvar dermatosis who had sharp pain?||||||0.0143|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus paper-cuts pain in patients with vulvar dermatosis who had sharp vulvar pain.||||0.0143
71100542|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar sticking versus stabbing in the patients with vulvar dermatosis who had sharp pain?||||||0.2059|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus stabbing in patients with vulvar dermatosis who had sharp vulvar pain.||||0.2059
71100543|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stabbing versus knife-like pain in the patients with vulvar dermatosis who had sharp pain?||||||0.682|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stabbing versus knife-like pain in patients with vulvar dermatosis who had sharp vulvar pain.||||0.6820
71100544|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stabbing versus paper-cuts pain in the patients with vulvar dermatosis who had sharp pain?||||||0.2059|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stabbing versus paper-cuts pain in patients with vulvar dermatosis who had sharp vulvar pain.||||0.2059
71042045|NCT01396421|141593539|SUPERIORITY_OR_OTHER||Treatment difference|-3.45||||0.036|TWO_SIDED|95.0|-6.67|-0.23||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3||||-0.23|-6.67|0.0360
71042046|NCT01396421|141593539|SUPERIORITY_OR_OTHER||Treatment difference|0.04||||0.9876|TWO_SIDED|95.0|-4.53|4.6||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 4||||4.60|-4.53|0.9876
71042047|NCT01396421|141593539|SUPERIORITY_OR_OTHER||Treatment difference|-7.61|||<|0.0001|TWO_SIDED|95.0|-11.3|-3.93||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 4||||-3.93|-11.3|<0.0001
71042048|NCT01396421|141593539|SUPERIORITY_OR_OTHER||Treatment difference|-5.16||||0.0062|TWO_SIDED|95.0|-8.85|-1.47||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates|Mixed Models Analysis|Week 4||||-1.47|-8.85|0.0062
71042049|NCT01396421|141593539|SUPERIORITY_OR_OTHER||Treatment difference|1.93||||0.3407|TWO_SIDED|95.0|-2.05|5.9||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3||||5.90|-2.05|0.3407
71100545|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus burning in the patients with vulvodynia?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus burning in patients with vulvodynia.||||0.0000
71100546|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus soreness in the patients with vulvodynia?||||||0.0344|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus soreness in patients with vulvodynia.||||0.0344
71042050|NCT01396421|141593539|SUPERIORITY_OR_OTHER||Treatment difference|-7.86||||0.0001|TWO_SIDED|95.0|-11.9|-3.86||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates|Mixed Models Analysis|Week 5||||-3.86|-11.9|0.0001
71042051|NCT01396421|141593539|SUPERIORITY_OR_OTHER||Treatment difference|-7.15||||0.0005|TWO_SIDED|95.0|-11.2|-3.14||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 5||||-3.14|-11.2|0.0005
71042052|NCT01396421|141593539|SUPERIORITY_OR_OTHER||Treatment difference|-1.12||||0.657|TWO_SIDED|95.0|-6.07|3.83||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 5|Because only the comparison of brexpiprazole 4 mg/day versus placebo met the threshold in the primary analysis, the following analysis is not part for the formal statistical testing and is descriptive only.|||3.83|-6.07|0.6570
71042053|NCT01396421|141593540|SUPERIORITY_OR_OTHER||Treatment difference|-0.02||||0.6553|TWO_SIDED|95.0|-0.13|0.08||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 1||||0.08|-0.13|0.6553
71100547|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus irritation in the patients with vulvodynia?||||||0.0023|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus irritation in patients with vulvodynia.||||0.0023
71000350|NCT03803202|141506966|OTHER||Mean Difference|0.2||||0.502|TWO_SIDED|95.0|-0.3|0.6|||ANCOVA|||Serotype 10A, Day 30||0.6|-0.3|0.502
71042054|NCT01396421|141593540|SUPERIORITY_OR_OTHER||Treatment difference|-0.03||||0.617|TWO_SIDED|95.0|-0.13|0.08||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 1||||0.08|-0.13|0.6170
71042055|NCT01396421|141593540|SUPERIORITY_OR_OTHER||Treatment difference|0.03||||0.6446|TWO_SIDED|95.0|-0.1|0.15||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates..|Mixed Models Analysis|Week 1||||0.15|-0.10|0.6446
71042056|NCT01396421|141593540|SUPERIORITY_OR_OTHER||Treatment difference|-0.15||||0.0347|TWO_SIDED|95.0|-0.29|-0.01||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 2||||-0.01|-0.29|0.0347
71042057|NCT01396421|141593540|SUPERIORITY_OR_OTHER||Leasr squares mean|-0.12||||0.0825|TWO_SIDED|95.0|-0.27|0.02||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.02|-0.27|0.0825
71042058|NCT01396421|141593540|SUPERIORITY_OR_OTHER||Treatment difference|0.12||||0.1678|TWO_SIDED|95.0|-0.05|0.3||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 2||||0.30|-0.05|0.1678
71042059|NCT01396421|141593540|SUPERIORITY_OR_OTHER||Treatment difference|-0.21||||0.0219|TWO_SIDED|95.0|-0.39|-0.03||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3||||-0.03|-0.39|0.0219
71100548|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus itching in the patients with vulvodynia?||||||0.5675|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus itching in patients with vulvodynia.||||0.5675
71100549|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus the feeling of inflammation in the patients with vulvodynia?||||||0.0037|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus the feeling of inflammation in patients with vulvodynia.||||0.0037
71000351|NCT03803202|141506966|OTHER||Mean Difference|0.5||||0.054|TWO_SIDED|95.0|0.0|1.0|||ANCOVA|||Serotype 10A, Day 30||1.0|0.0|0.054
71000352|NCT03803202|141506966|OTHER||Mean Difference|0.3||||0.19|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|||Serotype 10A, Day 30||0.8|-0.2|0.190
71000353|NCT03803202|141506966|OTHER||Mean Difference|0.1||||0.616|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 11A, Day 30||0.4|-0.3|0.616
71000354|NCT03803202|141506966|OTHER||Mean Difference|0.4||||0.018|TWO_SIDED|95.0|0.1|0.8|||ANCOVA|||Serotype 11A, Day 30||0.8|0.1|0.018
71000355|NCT03803202|141506966|OTHER||Mean Difference|0.4||||0.056|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Serotype 11A, Day 30||0.7|0.0|0.056
71000356|NCT03803202|141506966|OTHER||Mean Difference|0.2||||0.527|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||Serotype 12F, Day 30||0.7|-0.4|0.527
71000357|NCT03803202|141506966|OTHER||Mean Difference|0.2||||0.444|TWO_SIDED|95.0|-0.4|0.8|||ANCOVA|||Serotype 12F, Day 30||0.8|-0.4|0.444
71000358|NCT03803202|141506966|OTHER||Mean Difference|0.0||||0.869|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||Serotype 12F, Day 30||0.6|-0.5|0.869
71000359|NCT03803202|141506966|OTHER||Mean Difference|0.3||||0.305|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Serotype 14, Day 30||0.7|-0.2|0.305
71000360|NCT03803202|141506966|OTHER||Mean Difference|0.5||||0.046|TWO_SIDED|95.0|0.0|1.0|||ANCOVA|||Serotype 14, Day 30||1.0|0.0|0.046
71000361|NCT03803202|141506966|OTHER||Mean Difference|0.3||||0.299|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|||Serotype 14, Day 30||0.8|-0.2|0.299
71000362|NCT03803202|141506966|OTHER||Mean Difference|0.3||||0.14|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 15B, Day 30||0.7|-0.1|0.140
71000363|NCT03803202|141506966|OTHER||Mean Difference|0.9|||<|0.001|TWO_SIDED|95.0|0.4|1.3|||ANCOVA|||Serotype 15B, Day 30||1.3|0.4|<.001
71000364|NCT03803202|141506966|OTHER||Mean Difference|0.6||||0.012|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|||Serotype 15B, Day 30||1.0|0.1|0.012
71000365|NCT03803202|141506966|OTHER||Mean Difference|0.2||||0.2|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 17F, Day 30||0.6|-0.1|0.200
71042060|NCT01396421|141593540|SUPERIORITY_OR_OTHER||Least squares mean|-0.09||||0.3275|TWO_SIDED|95.0|-0.27|0.09||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3||||0.09|-0.27|0.3275
71042061|NCT01396421|141593540|SUPERIORITY_OR_OTHER||Treatment difference|0.18||||0.1173|TWO_SIDED|95.0|-0.04|0.4||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3||||0.40|-0.04|0.1173
71042062|NCT01396421|141593540|SUPERIORITY_OR_OTHER||Treatment difference|-0.42|||<|0.0001|TWO_SIDED|95.0|-0.63|-0.21||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 4||||-0.21|-0.63|<0.0001
71042063|NCT01396421|141593540|SUPERIORITY_OR_OTHER||Least squares mean|-0.19||||0.0662|TWO_SIDED|95.0|-0.4|0.01||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 4||||0.01|-0.40|0.0662
71042064|NCT01396421|141593540|SUPERIORITY_OR_OTHER||Treatment difference|-0.04||||0.7587|TWO_SIDED|95.0|-0.3|0.22||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 4||||0.22|-0.30|0.7587
71100550|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus aching in the patients with vulvodynia?||||||0.0005|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus aching in patients with vulvodynia.||||0.0005
70923970|NCT00812461|141340013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.11||0.111|TWO_SIDED|95.0|-0.38|0.04|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 225 participants in the placebo group and 203 participants in the nalmefene group.|MMRM model with the Baseline CGI-S score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline CGI-S score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used.||0.04|-0.38|0.111
70923971|NCT00812461|141340014|SUPERIORITY_OR_OTHER||Ratio to placebo|0.96||||0.529|TWO_SIDED|95.0|0.86|1.08|||[Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 224 participants in the placebo group and 207 participants in the nalmefene group.|Log-transformed GGT values were analysed using an MMRM model with the log-transformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Logtransformed Baseline value-by-time interaction and treatment-by-time interaction were included in the model. An unstructured covariance matrix was used.||1.08|0.86|0.529
71000366|NCT03803202|141506966|OTHER||Mean Difference|0.4||||0.037|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||Serotype 17F, Day 30||0.8|0.0|0.037
71000367|NCT03803202|141506966|OTHER||Mean Difference|0.2||||0.38|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 17F, Day 30||0.6|-0.2|0.380
71000368|NCT03803202|141506966|OTHER||Mean Difference|0.6||||0.006|TWO_SIDED|95.0|0.2|1.0|||ANCOVA|||Serotype 18C, Day 30||1.0|0.2|0.006
71042065|NCT01396421|141593540|SUPERIORITY_OR_OTHER||Treatment difference|-0.39||||0.0006|TWO_SIDED|95.0|-0.61|-0.17||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 5||||-0.17|-0.61|0.0006
71042066|NCT01396421|141593540|SUPERIORITY_OR_OTHER||Least squares mean|-0.34||||0.0032|TWO_SIDED|95.0|-0.56|-0.11||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 5||||-0.11|-0.56|0.0032
71100551|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus burning in the patients with vulvodynia?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus burning in patients with vulvodynia.||||0.0000
71100552|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus soreness in the patients with vulvodynia?||||||0.1201|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus soreness in patients with vulvodynia.||||0.1201
71100553|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus irritation in the patients with vulvodynia?||||||0.0123|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus irritation in patients with vulvodynia.||||0.0123
71100554|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus the feeling of inflammation in the patients with vulvodynia?||||||0.0188|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus the feeling of inflammation in patients with vulvodynia.||||0.0188
71100555|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus aching in the patients with vulvodynia?||||||0.003|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus aching in patients with vulvodynia.||||0.0030
71000369|NCT03803202|141506966|OTHER||Mean Difference|0.5||||0.018|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|||Serotype 18C, Day 30||1.0|0.1|0.018
71000370|NCT03803202|141506966|OTHER||Mean Difference|-0.1||||0.81|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|||Serotype 18C, Day 30||0.4|-0.5|0.810
71000371|NCT03803202|141506966|OTHER||Mean Difference|0.3||||0.173|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 19A, Day 30||0.7|-0.1|0.173
71000372|NCT03803202|141506966|OTHER||Mean Difference|0.4||||0.096|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 19A, Day 30||0.8|-0.1|0.096
71000373|NCT03803202|141506966|OTHER||Mean Difference|0.1||||0.71|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Serotype 19A, Day 30||0.5|-0.3|0.710
71000374|NCT03803202|141506966|OTHER||Mean Difference|0.4||||0.1|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 19F, Day 30||0.8|-0.1|0.100
71000375|NCT03803202|141506966|OTHER||Mean Difference|0.6||||0.007|TWO_SIDED|95.0|0.2|1.1|||ANCOVA|||Serotype 19F, Day 30||1.1|0.2|0.007
71000376|NCT03803202|141506966|OTHER||Mean Difference|0.3||||0.251|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Serotype 19F, Day 30||0.7|-0.2|0.251
71000377|NCT03803202|141506966|OTHER||Mean Difference|0.1||||0.618|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Serotype 20B, Day 30||0.5|-0.3|0.618
71042067|NCT01396421|141593540|SUPERIORITY_OR_OTHER||Treatment difference|-0.04||||0.7619|TWO_SIDED|95.0|-0.32|0.23||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 5||||0.23|-0.32|0.7619
71042068|NCT01396421|141593541|SUPERIORITY_OR_OTHER||Treatment difference|2.46||||0.0557|TWO_SIDED|95.0|-0.06|4.98||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 6||||4.98|-0.06|0.0557
71100556|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus burning in the patients with vulvodynia?||||||0.2155|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus burning in patients with vulvodynia.||||0.2155
71000378|NCT03803202|141506966|OTHER||Mean Difference|0.5||||0.041|TWO_SIDED|95.0|0.0|0.9|||ANCOVA|||Serotype 20B, Day 30||0.9|0.0|0.041
71000379|NCT03803202|141506966|OTHER||Mean Difference|0.3||||0.111|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 20B, Day 30||0.8|-0.1|0.111
71000380|NCT03803202|141506966|OTHER||Mean Difference|0.1||||0.758|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 22F, Day 30||0.4|-0.3|0.758
71000381|NCT03803202|141506966|OTHER||Mean Difference|0.5||||0.012|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Serotype 22F, Day 30||0.9|0.1|0.012
71000382|NCT03803202|141506966|OTHER||Mean Difference|0.4||||0.025|TWO_SIDED|95.0|0.1|0.8|||ANCOVA|||Serotype 22F, Day 30||0.8|0.1|0.025
71000383|NCT03803202|141506966|OTHER||Mean Difference|0.0||||0.912|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|||Serotype 23F, Day 30||0.4|-0.5|0.912
71000384|NCT03803202|141506966|OTHER||Mean Difference|0.3||||0.174|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 23F, Day 30||0.8|-0.1|0.174
71000385|NCT03803202|141506966|OTHER||Mean Difference|0.3||||0.138|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 23F, Day 30||0.8|-0.1|0.138
71000386|NCT03803202|141506966|OTHER||Mean Difference|0.2||||0.267|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Serotype 33F, Day 30||0.7|-0.2|0.267
71042069|NCT01396421|141593541|SUPERIORITY_OR_OTHER||Treatment difference|2.89||||0.025|TWO_SIDED|95.0|0.37|5.42||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 6||||5.42|0.37|0.0250
71000387|NCT03803202|141506966|OTHER||Mean Difference|0.2||||0.3|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Serotype 33F, Day 30||0.7|-0.2|0.300
71000388|NCT03803202|141506966|OTHER||Mean Difference|0.0||||0.982|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Serotype 33F, Day 30||0.4|-0.4|0.982
71000389|NCT03803202|141506967|OTHER||Ratio of GMT|1.49|||||TWO_SIDED|95.0|1.06|2.08|||t-test, 2 sided|||Serotype 2||2.08|1.06|
71000390|NCT03803202|141506967|OTHER||Ratio of GMT|0.97|||||TWO_SIDED|95.0|0.68|1.37|||t-test, 2 sided|||Serotype 8||1.37|0.68|
71000391|NCT03803202|141506967|OTHER||Ratio of GMT|1.35|||||TWO_SIDED|95.0|0.92|2.0|||t-test, 2 sided|||Serotype 9N||2.00|0.92|
71000392|NCT03803202|141506967|OTHER||Ratio of GMT|2.18|||||TWO_SIDED|95.0|1.25|3.79|||t-test, 2 sided|||Serotype 10A||3.79|1.25|
71000393|NCT03803202|141506967|OTHER||Ratio of GMT|1.19|||||TWO_SIDED|95.0|0.8|1.77|||t-test, 2 sided|||Serotype 11A||1.77|0.80|
71000394|NCT03803202|141506967|OTHER||Ratio of GMT|1.2|||||TWO_SIDED|95.0|0.73|2.0|||t-test, 2 sided|||Serotype 12F||2.00|0.73|
71000395|NCT03803202|141506967|OTHER||Ratio of GMT|1.47|||||TWO_SIDED|95.0|0.94|2.29|||t-test, 2 sided|||Serotype 15B||2.29|0.94|
71000396|NCT03803202|141506967|OTHER||Ratio of GMT|2.61|||||TWO_SIDED|95.0|1.68|4.04|||t-test, 2 sided|||Serotype 17F||4.04|1.68|
71000397|NCT03803202|141506967|OTHER||Ratio of GMT|9.05|||||TWO_SIDED|95.0|5.65|14.5|||t-test, 2 sided|||Serotype 20B||14.50|5.65|
71000398|NCT03803202|141506967|OTHER||Ratio of GMT|1.79|||||TWO_SIDED|95.0|1.09|2.95|||t-test, 2 sided|||Serotype 22F||2.95|1.09|
71000399|NCT03803202|141506967|OTHER|Serotype 33F|Ratio of GMT|1.34|||||TWO_SIDED|95.0|0.86|2.11|||t-test, 2 sided|||||2.11|0.86|
71000400|NCT03803202|141506967|OTHER||Ratio of GMT|1.31|||||TWO_SIDED|95.0|0.93|1.83|||t-test, 2 sided|||Serotype 2||1.83|0.93|
71000401|NCT03803202|141506967|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.67|1.43|||t-test, 2 sided|||Serotype 8||1.43|0.67|
71000402|NCT03803202|141506967|OTHER||Ratio of GMT|1.62|||||TWO_SIDED|95.0|1.62|2.26|||t-test, 2 sided|||Serotype 9N||2.26|1.62|
71000403|NCT03803202|141506967|OTHER||Ratio of GMT|2.87|||||TWO_SIDED|95.0|1.68|4.9|||t-test, 2 sided|||Serotype 10A||4.90|1.68|
71000404|NCT03803202|141506967|OTHER||Ratio of GMT|1.42|||||TWO_SIDED|95.0|0.98|2.06|||t-test, 2 sided|||Serotype 11A||2.06|0.98|
71000405|NCT03803202|141506967|OTHER||Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.54|1.48|||t-test, 2 sided|||Serotype 12F||1.48|0.54|
71000406|NCT03803202|141506967|OTHER||Ratio of GMT|1.09|||||TWO_SIDED|95.0|0.73|1.64|||t-test, 2 sided|||Serotype 15B||1.64|0.73|
71000407|NCT03803202|141506967|OTHER||Ratio of GMT|2.13|||||TWO_SIDED|95.0|1.4|3.25|||t-test, 2 sided|||Serotype 17F||3.25|1.40|
71000408|NCT03803202|141506967|OTHER||Ratio of GMT|7.28|||||TWO_SIDED|95.0|4.61|11.5|||t-test, 2 sided|||Serotype 20B||11.50|4.61|
71000409|NCT03803202|141506967|OTHER||Ratio of GMT|1.55|||||TWO_SIDED|95.0|0.96|2.48|||t-test, 2 sided|||Serotype 22F||2.48|0.96|
71000410|NCT03803202|141506967|OTHER||Ratio of GMT|1.24|||||TWO_SIDED|95.0|0.83|1.84|||t-test, 2 sided|||Serotype 33F||1.84|0.83|
71000411|NCT03803202|141506967|OTHER||Ratio of GMT|2.1|||||TWO_SIDED|95.0|1.51|2.94|||t-test, 2 sided|||Serotype 2||2.94|1.51|
71000412|NCT03803202|141506967|OTHER||Ratio of GMT|2.08|||||TWO_SIDED|95.0|1.46|2.97|||t-test, 2 sided|||Serotype 8||2.97|1.46|
71000413|NCT03803202|141506967|OTHER||Ratio of GMT|2.24|||||TWO_SIDED|95.0|1.56|3.2|||t-test, 2 sided|||Serotype 9N||3.20|1.56|
71000414|NCT03803202|141506967|OTHER||Ratio of GMT|3.24|||||TWO_SIDED|95.0|1.79|5.89|||t-test, 2 sided|||Serotype 10A||5.89|1.79|
71042070|NCT01396421|141593541|SUPERIORITY_OR_OTHER||Treatment difference|1.58||||0.3264|TWO_SIDED|95.0|-1.58|4.74||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 6||||4.74|-1.58|0.3264
71042071|NCT01396421|141593542|SUPERIORITY_OR_OTHER||Treatment difference|-2.44||||0.001|TWO_SIDED|95.0|-3.88|-0.99||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.99|-3.88|0.0010
71042072|NCT01396421|141593542|SUPERIORITY_OR_OTHER||Treatment difference|-2.22||||0.0029|TWO_SIDED|95.0|-3.67|-0.77||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.77|-3.67|0.0029
71042073|NCT01396421|141593542|SUPERIORITY_OR_OTHER||Treatment difference|-1.11||||0.2227|TWO_SIDED|95.0|-2.9|0.68||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.68|-2.90|0.2227
71042074|NCT01396421|141593543|SUPERIORITY_OR_OTHER||Treatment difference|-1.41||||0.0069|TWO_SIDED|95.0|-2.44|0.39||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.39|-2.44|0.0069
71042075|NCT01396421|141593543|SUPERIORITY_OR_OTHER||Least squares mean|-1.78||||0.0007|TWO_SIDED|95.0|-2.81|-0.76||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.76|-2.81|0.0007
71042076|NCT01396421|141593543|SUPERIORITY_OR_OTHER||Treatmetn difference|-1.07||||0.0996|TWO_SIDED|95.0|-2.33|0.2||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.20|-2.33|0.0996
71042077|NCT01396421|141593544|SUPERIORITY_OR_OTHER||Treatment difference|-0.5||||0.0004|TWO_SIDED|95.0|-0.77|-0.22||The Cochran-Mantel-Haenzel (CMH) row mean scores differ test controlling for trial center was applied to CGI-I score.|Cochran-Mantel-Haenszel|||||-0.22|-0.77|0.0004
71042078|NCT01396421|141593544|SUPERIORITY_OR_OTHER||Treatment difference|-0.54||||0.0002|TWO_SIDED|95.0|-0.82|-0.26||The CMH row mean scores differ test controlling for trial center was applied to CGI-I score.|Cochran-Mantel-Haenszel|||||-0.26|-0.82|0.0002
71042079|NCT01396421|141593544|SUPERIORITY_OR_OTHER||Treatment difference|-0.14||||0.4505|TWO_SIDED|95.0|-0.5|0.22||The CMH row mean scores differ test controlling for trial center was applied to CGI-I score.|Cochran-Mantel-Haenszel|||||0.22|-0.50|0.4505
71042080|NCT01396421|141593545|SUPERIORITY_OR_OTHER||Relative risk|1.48||||0.0032|TWO_SIDED|95.0|1.14|1.91||CMH general association test controlling for trial was applied to the analysis of response rate.|Cochran-Mantel-Haenszel|||||1.91|1.14|0.0032
71042081|NCT01396421|141593545|SUPERIORITY_OR_OTHER||Relative risk|1.59||||0.0004|TWO_SIDED|95.0|1.23|2.05||CMH general association test controlling for trial was applied to the analysis of response rate.|Cochran-Mantel-Haenszel|||||2.05|1.23|0.0004
71042082|NCT01396421|141593545|SUPERIORITY_OR_OTHER||Relative risk|1.27||||0.1576|TWO_SIDED|95.0|0.92|1.76||CMH general association test controlling for trial was applied to the analysis of response rate.|Cochran-Mantel-Haenszel|||||1.76|0.92|0.1576
71042083|NCT01396421|141593546|SUPERIORITY_OR_OTHER||Treatment difference|-1.1||||0.0246|TWO_SIDED|95.0|-2.06|-0.14||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.14|-2.06|0.0246
71042084|NCT01396421|141593546|SUPERIORITY_OR_OTHER||Treatment difference|-1.22||||0.0131|TWO_SIDED|95.0|-2.19|-0.26||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.26|-2.19|0.0131
71042085|NCT01396421|141593546|SUPERIORITY_OR_OTHER||Treatment difference|-0.34||||0.5706|TWO_SIDED|95.0|-1.53|0.85||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.85|-1.53|0.5706
71042086|NCT01396421|141593547|SUPERIORITY_OR_OTHER||Relative risk|0.39||||0.0143|TWO_SIDED|95.0|0.18|0.85|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial center was applied to the analysis of discontinuation rate.||||0.85|0.18|0.0143
70923972|NCT00812461|141340015|SUPERIORITY_OR_OTHER||Ratio to placebo|0.92||||0.049|TWO_SIDED|95.0|0.84|1.0|||[Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 222 participants in the placebo group and 205 participants in the nalmefene group.|Log-transformed ALAT values were analysed using an MMRM model with the log-transformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Logtransformed Baseline value-by-time and treatment-by-time interactions were included in the model. An unstructured covariance matrix was used.||1.00|0.84|0.049
71042087|NCT01396421|141593547|SUPERIORITY_OR_OTHER||Relative risk|0.87||||0.6606|TWO_SIDED|95.0|0.46|1.65||CMH general association test controlling for trial center was applied to the analysis of discontinuation rate.|Cochran-Mantel-Haenszel|||||1.65|0.46|0.6606
71042088|NCT01396421|141593547|SUPERIORITY_OR_OTHER||Relative risk|0.77||||0.5115|TWO_SIDED|95.0|0.35|1.68||CMH general association test controlling for trial center was applied to the analysis of discontinuation rate.|Cochran-Mantel-Haenszel|||||1.68|0.35|0.5115
71042089|NCT01396421|141593548|SUPERIORITY_OR_OTHER||Treatment difference|-2.34||||0.0014|TWO_SIDED|95.0|-3.77|-0.91||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.91|-3.77|0.0014
71042090|NCT01396421|141593548|SUPERIORITY_OR_OTHER||Treatment difference|-2.47||||0.0008|TWO_SIDED|95.0|-3.91|-1.04||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-1.04|-3.91|0.0008
71042091|NCT01396421|141593548|SUPERIORITY_OR_OTHER||Treatment difference|-0.89||||0.3263|TWO_SIDED|95.0|-2.66|0.89||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates|Mixed Models Analysis|||||0.89|-2.66|0.3263
71042092|NCT01396421|141593549|SUPERIORITY_OR_OTHER||Treatment difference|-1.3||||0.0155|TWO_SIDED|95.0|-2.35|-0.25||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.25|-2.35|0.0155
71042093|NCT01396421|141593549|SUPERIORITY_OR_OTHER||Treatment difference|-1.68||||0.0019|TWO_SIDED|95.0|-2.73|-0.62||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.62|-2.73|0.0019
71042094|NCT01396421|141593549|SUPERIORITY_OR_OTHER||Treatment difference|-0.86||||0.1956|TWO_SIDED|95.0|-2.17|0.44||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.44|-2.17|0.1956
70923973|NCT03964350|141340022|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
71042095|NCT01396421|141593550|SUPERIORITY_OR_OTHER||Treatment difference|-1.75||||0.0007|TWO_SIDED|95.0|-2.76|-0.75||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.75|-2.76|0.0007
71000415|NCT03803202|141506967|OTHER||Ratio of GMT|2.43|||||TWO_SIDED|95.0|1.63|3.62|||t-test, 2 sided|||Serotype 11A||3.62|1.63|
71000416|NCT03803202|141506967|OTHER||Ratio of GMT|1.51|||||TWO_SIDED|95.0|0.89|2.55|||t-test, 2 sided|||Serotype 12 F||2.55|0.89|
71000417|NCT03803202|141506967|OTHER||Ratio of GMT|1.69|||||TWO_SIDED|95.0|1.11|2.57|||t-test, 2 sided|||Serotype 15B||2.57|1.11|
71000418|NCT03803202|141506967|OTHER||Ratio of GMT|3.37|||||TWO_SIDED|95.0|2.18|5.2|||t-test, 2 sided|||Serotype 17F||5.20|2.18|
71000419|NCT03803202|141506967|OTHER||Ratio of GMT|13.7|||||TWO_SIDED|95.0|8.26|22.72|||t-test, 2 sided|||Serotype 20B||22.72|8.26|
71000420|NCT03803202|141506967|OTHER||Ratio of GMT|2.17|||||TWO_SIDED|95.0|1.36|3.46|||t-test, 2 sided|||Serotype 22F||3.46|1.36|
71000421|NCT03803202|141506967|OTHER||Ratio of GMT|1.69|||||TWO_SIDED|95.0|1.11|2.57|||t-test, 2 sided|||Serotype 33F||2.57|1.11|
71000422|NCT03803202|141506968|OTHER||Ratio of GMT|1.35|||||TWO_SIDED|95.0|0.95|1.93|||t-test, 2 sided|||Serotype 2||1.93|0.95|
71000423|NCT03803202|141506968|OTHER||Ratio of GMT|1.51|||||TWO_SIDED|95.0|1.07|2.13|||t-test, 2 sided|||Serotype 8||2.13|1.07|
71000424|NCT03803202|141506968|OTHER||Ratio of GMT|1.59|||||TWO_SIDED|95.0|1.09|2.33|||t-test, 2 sided|||Serotype 9N||2.33|1.09|
71042096|NCT01396421|141593550|SUPERIORITY_OR_OTHER||Treatment difference|-1.98||||0.0001|TWO_SIDED|95.0|-2.98|-0.97||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.97|-2.98|0.0001
71042097|NCT01396421|141593550|SUPERIORITY_OR_OTHER||Treatment difference|-0.72||||0.2572|TWO_SIDED|95.0|-1.96|0.52||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.52|-1.96|0.2572
71000425|NCT03803202|141506968|OTHER||Ratio of GMT|2.24|||||TWO_SIDED|95.0|1.45|3.47|||t-test, 2 sided|||Serotype 10A||3.47|1.45|
71000426|NCT03803202|141506968|OTHER||Ratio of GMT|1.83|||||TWO_SIDED|95.0|1.27|2.65|||t-test, 2 sided|||Serotype 11A||2.65|1.27|
71000427|NCT03803202|141506968|OTHER||Ratio of GMT|1.31|||||TWO_SIDED|95.0|0.77|2.23|||t-test, 2 sided|||Serotype 12F||2.23|0.77|
71042098|NCT01396421|141593551|SUPERIORITY_OR_OTHER||Treatment difference|-1.07||||0.0085|TWO_SIDED|95.0|-1.87|-0.28||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.28|-1.87|0.0085
71000428|NCT03803202|141506968|OTHER||Ratio of GMT|1.24|||||TWO_SIDED|95.0|0.8|1.91|||t-test, 2 sided|||Serotype 15B||1.91|0.80|
71000429|NCT03803202|141506968|OTHER||Ratio of GMT|2.63|||||TWO_SIDED|95.0|1.7|4.07|||t-test, 2 sided|||Serotype 17F||4.07|1.70|
71000430|NCT03803202|141506968|OTHER||Ratio of GMT|2.43|||||TWO_SIDED|95.0|1.61|3.67|||t-test, 2 sided|||Serotype 20B||3.67|1.61|
71000431|NCT03803202|141506968|OTHER||Ratio of GMT|2.49|||||TWO_SIDED|95.0|1.7|3.65|||t-test, 2 sided|||Serotype 22F||3.65|1.70|
71000432|NCT03803202|141506968|OTHER||Ratio of GMT|1.67|||||TWO_SIDED|95.0|1.1|2.54|||t-test, 2 sided|||Serotype 33F||2.54|1.10|
71000433|NCT03803202|141506968|OTHER||Ratio of GMT|1.42|||||TWO_SIDED|95.0|0.98|2.07|||t-test, 2 sided|||Serotype 2||2.07|0.98|
71000434|NCT03803202|141506968|OTHER||Ratio of GMT|1.58|||||TWO_SIDED|95.0|1.11|2.26|||t-test, 2 sided|||Serotype 8||2.26|1.11|
71000435|NCT03803202|141506968|OTHER||Ratio of GMT|1.83|||||TWO_SIDED|95.0|1.23|2.72|||t-test, 2 sided|||Serotype 9N||2.72|1.23|
71000436|NCT03803202|141506968|OTHER||Ratio of GMT|2.59|||||TWO_SIDED|95.0|1.66|4.05||||||Serotype 10A||4.05|1.66|
71000437|NCT03803202|141506968|OTHER||Ratio of GMT|1.9|||||TWO_SIDED|95.0|1.32|2.73|||t-test, 2 sided|||Serotype 11A||2.73|1.32|
71000438|NCT03803202|141506968|OTHER||Ratio of GMT|1.59|||||TWO_SIDED|95.0|0.93|2.71|||t-test, 2 sided|||Serotype 12F||2.71|0.93|
71000439|NCT03803202|141506968|OTHER||Ratio of GMT|1.68|||||TWO_SIDED|95.0|1.11|2.53|||t-test, 2 sided|||Serotype 15B||2.53|1.11|
71000440|NCT03803202|141506968|OTHER||Ratio of GMT|3.27|||||TWO_SIDED|95.0|2.17|4.93|||t-test, 2 sided|||Serotype 17F||4.93|2.17|
71000441|NCT03803202|141506968|OTHER||Ratio of GMT|2.79|||||TWO_SIDED|95.0|1.85|4.22|||t-test, 2 sided|||Serotype 20B||4.22|1.85|
71000442|NCT03803202|141506968|OTHER||Ratio of GMT|2.63|||||TWO_SIDED|95.0|1.79|3.88|||t-test, 2 sided|||Serotype 22F||3.88|1.79|
71000443|NCT03803202|141506968|OTHER||Ratio of GMT|2.05|||||TWO_SIDED|95.0|1.4|3.01|||t-test, 2 sided|||Serotype 33F||3.01|1.40|
71000444|NCT03803202|141506968|OTHER||Ratio of GMT|1.97|||||TWO_SIDED|95.0|1.37|2.84|||t-test, 2 sided|||Serotype 2||2.84|1.37|
71000445|NCT03803202|141506968|OTHER||Ratio of GMT|2.98|||||TWO_SIDED|95.0|2.12|4.18|||t-test, 2 sided|||Serotype 8||4.18|2.12|
71000446|NCT03803202|141506968|OTHER||Ratio of GMT|2.99|||||TWO_SIDED|95.0|2.02|4.44|||t-test, 2 sided|||Serotype 9N||4.44|2.02|
71000447|NCT03803202|141506968|OTHER||Ratio of GMT|3.63|||||TWO_SIDED|95.0|2.25|5.86|||t-test, 2 sided|||Serotype 10A||5.86|2.25|
71000448|NCT03803202|141506968|OTHER||Ratio of GMT|2.86|||||TWO_SIDED|95.0|1.96|4.18|||t-test, 2 sided|||Serotype 11A||4.18|1.96|
71000449|NCT03803202|141506968|OTHER||Ratio of GMT|1.64|||||TWO_SIDED|95.0|0.91|2.96|||t-test, 2 sided|||Serotype 12F||2.96|0.91|
71000450|NCT03803202|141506968|OTHER||Ratio of GMT|2.93|||||TWO_SIDED|95.0|1.87|4.61|||t-test, 2 sided|||Serotype 15B||4.61|1.87|
71000451|NCT03803202|141506968|OTHER||Ratio of GMT|4.0|||||TWO_SIDED|95.0|2.55|6.26|||t-test, 2 sided|||Serotype 17F||6.26|2.55|
71000452|NCT03803202|141506968|OTHER||Ratio of GMT|3.82|||||TWO_SIDED|95.0|2.46|5.91|||t-test, 2 sided|||Serotype 22F||5.91|2.46|
71000453|NCT03803202|141506968|OTHER||Ratio of GMT|4.02|||||TWO_SIDED|95.0|2.74|5.9|||t-test, 2 sided|||Serotype 22F||5.90|2.74|
71000454|NCT03803202|141506968|OTHER||Ratio of GMT|2.11|||||TWO_SIDED|95.0|1.38|3.23|||t-test, 2 sided|||Serotype 33F||3.23|1.38|
71042099|NCT01396421|141593551|SUPERIORITY_OR_OTHER||Treatment difference|-1.08||||0.0081|TWO_SIDED|95.0|-1.88|-0.28||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.28|-1.88|0.0081
71042100|NCT01396421|141593551|SUPERIORITY_OR_OTHER||Treatment difference|-0.33||||0.5172|TWO_SIDED|95.0|-1.31|0.66||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.66|-1.31|0.5172
71042101|NCT01396421|141593552|SUPERIORITY_OR_OTHER||Treatment difference|-0.34||||0.3284|TWO_SIDED|95.0|-1.03|0.35||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.35|-1.03|0.3284
71042102|NCT01396421|141593552|SUPERIORITY_OR_OTHER||Treatment difference|-0.65||||0.0655|TWO_SIDED|95.0|-1.34|0.04||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.04|-1.34|0.0655
71042103|NCT01396421|141593552|SUPERIORITY_OR_OTHER||Treatment difference|-0.21||||0.6251|TWO_SIDED|95.0|-1.07|0.64||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.64|-1.07|0.6251
71042104|NCT04728620|141593553|SUPERIORITY|single group|mean|79.3||||0.001|TWO_SIDED||||||t-test, 1 sided|||"One-sample t-test comparing the sample mean to the threshold value of 71 indicative of good usability. The null hypothesis: true mean is 71 or less."||||0.001
71042105|NCT04728620|141593555|OTHER||Mean Difference (Net)|0.57||||0.005|TWO_SIDED||||||t-test, 2 sided|||||||0.005
71042106|NCT04728620|141593556|OTHER||Mean Difference (Net)|-0.85||||0.19|TWO_SIDED||||||t-test, 2 sided|||||||0.19
71042107|NCT04728620|141593557|OTHER|||||||1|||||||McNemar|||Analysis for pre-post change in knowledge of recommended A1c monitoring frequency||||1
71042108|NCT04728620|141593557|OTHER|||||||1|||||||McNemar|||Analysis for pre-post change in knowledge of recommended urine microalbumin screening frequency||||1
71100557|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus soreness in the patients with vulvodynia?||||||0.1508|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus soreness in patients with vulvodynia.||||0.1508
71100558|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus irritation in the patients with vulvodynia?||||||0.6364|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus irritation in patients with vulvodynia.||||0.6364
71100559|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus the feeling of inflammation in the patients with vulvodynia?||||||0.5277|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus the feeling of inflammation in patients with vulvodynia.||||0.5277
71100560|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar sticking versus knife-like pain in the patients with vulvodynia who had sharp vulvar pain?||||||0.2041|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus knife-like pain in patients with vulvodynia who had sharp vulvar pain.||||0.2041
71042109|NCT04728620|141593557|OTHER|||||||1|||||||McNemar|||Analysis for pre-post change in knowledge of recommended pneumonia vaccination frequency||||1
71042110|NCT04728620|141593557|OTHER|||||||1|||||||McNemar|||Analysis for pre-post change in knowledge of recommended diabetes eye exam frequency||||1
71042111|NCT02875028|141593605|SUPERIORITY|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||||||0.029
71042112|NCT01989676|141593632|EQUIVALENCE|The hypothesis to be tested in this study was that the risk ratio of ORR of PF-05280014 versus that of trastuzumab-EU by Week 25 (+/-14 days) was within a pre-specified margin of 0.80 to 1.25.|Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.842|1.049||||||Risk Ratio and associated 95% confidence interval (CI) are unstratified and based on the Miettinen and Nurminen method.||1.049|0.842|
71042113|NCT01989676|141593633|SUPERIORITY||Cox Proportional Hazard|1.0||||0.505|TWO_SIDED|95.0|0.8|1.26||1-sided log-rank test was used to compare the PFS distribution between the two treatment groups and was stratified by prior trastuzumab exposure (Yes/No) and estrogen receptor (ER) status (ER positive vs. ER negative).|Log Rank||The 95% CI for the hazard ratio was based on the Cox's proportional hazard model.|||1.26|0.80|0.505
71042114|NCT01989676|141593634|SUPERIORITY||Cox Proportional Hazard|0.92||||0.304|TWO_SIDED|95.0|0.67|1.27||1-sided log-rank test was used to compare the DOR distribution between the two treatment groups and was stratified by prior trastuzumab exposure (Yes/No) and ER status (ER positive vs. ER negative).|Log Rank||The 95% CI for the hazard ratio was based on the Cox's proportional hazard model.|||1.27|0.67|0.304
71042115|NCT01989676|141593635|SUPERIORITY||Cox Proportional Hazard|0.929||||0.339|TWO_SIDED|95.0|0.656|1.316||1-sided log-rank test was used to compare the OS distribution between the two treatment groups and was stratified by prior trastuzumab exposure (Yes/No) and ER status (ER positive vs. ER negative).|Log Rank||The 95% CI for the hazard ratio was based on the Cox's proportional hazard model.|||1.316|0.656|0.339
71042116|NCT03941834|141593642|OTHER||Least square (LS) mean difference|0.7|||||TWO_SIDED|95.0|0.1|1.2||||||Analysis were performed using a mixed model with fixed effects for treatment, period and sequence; baseline NPRS as a covariate; and participant as a random effect.||1.2|0.1|
71042117|NCT03941834|141593647|OTHER||LS mean difference|2.4|||||TWO_SIDED|95.0|-6.8|11.5||||||Analysis was performed using a mixed model with fixed effects for treatment, period and sequence; baseline Penn-FPS-R as a covariate; and participant as a random effect.||11.5|-6.8|
71042118|NCT03941834|141593648|OTHER||LS Mean Difference|1.5|||||TWO_SIDED|95.0|-3.8|6.9||||||Analysis was performed using a mixed model with fixed effects for treatment, period and sequence; baseline pain disability index as a covariate; and participant as a random effect.||6.9|-3.8|
71042119|NCT03941834|141593649|OTHER||LS Mean Difference|-0.1|||||TWO_SIDED|95.0|-0.7|0.5||||||Analysis was performed using a mixed model with fixed effects for treatment, period and sequence; and participant as a random effect.||0.5|-0.7|
71042120|NCT03941834|141593650|OTHER||LS Mean Difference|0.7|||||TWO_SIDED|95.0|0.1|1.4||||||Analysis was performed using a mixed model with fixed effects for treatment, period and sequence; baseline NPRS as a covariate; and participant as a random effect.||1.4|0.1|
71042121|NCT03941834|141593651|OTHER||Odds Ratio (OR)|12.6|||||TWO_SIDED|95.0|0.7|229.6||||||Analysis was performed using a logistic regression model, including fixed effects for treatment, sequence, period and baseline NPRS score as a covariate.||229.6|0.7|
71100561|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar sticking versus paper-cuts pain in the patients with vulvodynia who had sharp vulvar pain?||||||0.0412|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus paper-cuts pain in patients with vulvodynia who had sharp vulvar pain.||||0.0412
71100562|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar sticking versus stabbing in the patients with vulvodynia who had sharp vulvar pain?||||||0.7978|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus stabbing in patients with vulvodynia who had sharp vulvar pain.||||0.7978
71100563|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stabbing versus knife-like pain in the patients with vulvodynia who had sharp vulvar pain?||||||0.3094|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stabbing versus knife-like pain in patients with vulvodynia who had sharp vulvar pain.||||0.3094
71100564|NCT02732145|141709674|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stabbing versus paper-cuts pain in the patients with vulvodynia who had sharp vulvar pain?||||||0.073|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stabbing versus paper-cuts pain in patients with vulvodynia who had sharp vulvar pain.||||0.0730
71100565|NCT02732145|141709674|EQUIVALENCE|Question: Is there a difference in the duration of vulvar complaints for more than 24 months among patients with vulvar dermatosis and vulvodynia?||||||0.4038|||||||Chi-squared|||Parameter: The difference in the duration of vulvar complaints for more than 24 months among patients with vulvar dermatosis or vulvodynia.||||0.4038
71100566|NCT02732145|141709674|EQUIVALENCE|Question: Is there a difference in the duration of vulvar complaints for more than 12 months among patients with vulvar dermatosis and vulvodynia?||||||0.7299|||||||Chi-squared|||Parameter: The difference in the duration of vulvar complaints for more than 12 months among patients with vulvar dermatosis or vulvodynia.||||0.7299
70923974|NCT04402489|141340024|SUPERIORITY||Least Square Mean Difference vs Placebo|9.8|STANDARD_ERROR_OF_MEAN|14.35||0.496|TWO_SIDED|95.0|-18.52|38.12|||Mixed-effect model for repeated measures|||Change from BL at Week 26 (DBT EOT) - lower dose||38.12|-18.52|0.496
70923975|NCT04402489|141340024|SUPERIORITY||Least Square Mean Difference vs Placebo|22.7|STANDARD_ERROR_OF_MEAN|14.38||0.116|TWO_SIDED|95.0|-5.68|51.09|||Mixed-effect model for repeated measures|||Change from BL at Week 26 (DBT EOT) - higher dose||51.09|-5.68|0.116
70923976|NCT04402489|141340025|SUPERIORITY||Least Square Mean Difference vs Placebo|-0.84|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.23|-0.44|||Mixed-effect model for repeated measures|||||-0.44|-1.23|< 0.001
70923977|NCT04402489|141340025|SUPERIORITY||Least Square Mean Difference vs Placebo|-1.43|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.83|-1.03|||Mixed-effect model for repeated measures|||||-1.03|-1.83|< 0.001
70923978|NCT04402489|141340026|SUPERIORITY|Negative binomial regression model with log link was used.|Incident rate ratio|0.76||||0.199|TWO_SIDED|95.0|0.49|1.16|||Refer to comments below:|Negative binomial regression model with log link was used for other method.||||1.16|0.49|0.199
70923979|NCT04402489|141340026|SUPERIORITY|Negative binomial regression model with log link was used.|Incident rate ratio|0.55||||0.006|TWO_SIDED|95.0|0.36|0.84|||Refer to comments below:|Negative binomial regression model with log link was used for other method.||||0.84|0.36|0.006
70923980|NCT04402489|141340027|SUPERIORITY||Least Square Mean Difference vs Placebo|-0.15|STANDARD_ERROR_OF_MEAN|0.24||0.55|TWO_SIDED|95.0|-0.62|0.33|||mixed-effect model for repeated measures|||||0.33|-0.62|0.55
70923981|NCT04402489|141340027|SUPERIORITY||Least Square Mean Difference vs Placebo|-0.23|STANDARD_ERROR_OF_MEAN|0.25||0.343|TWO_SIDED|95.0|-0.72|0.25|||mixed-effect model for repeated measures|||||0.25|-0.72|0.343
70923982|NCT04402489|141340028|SUPERIORITY||Odds Ratio (OR)|0.805||||0.642|TWO_SIDED|95.0|0.323|2.007|||Regression, Logistic|||||2.007|0.323|0.642
70923983|NCT04402489|141340028|SUPERIORITY||Odds Ratio (OR)|1.412||||0.431|TWO_SIDED|95.0|0.598|3.336|||Regression, Logistic|||||3.336|0.598|0.431
70923984|NCT04402489|141340029|SUPERIORITY||Least Square Mean Difference vs Placebo|0.87|STANDARD_ERROR_OF_MEAN|0.48||0.072|TWO_SIDED|95.0|-0.08|1.82|||mixed-effect model for repeated measures|||||1.82|-0.08|0.072
70923985|NCT04402489|141340029|SUPERIORITY||Least Square Mean Difference vs Placebo|0.56|STANDARD_ERROR_OF_MEAN|0.48||0.252|TWO_SIDED|95.0|-0.4|1.51|||mixed-effect model for repeated measures|||||1.51|-0.4|0.252
70923986|NCT05902793|141340030|NON_INFERIORITY|the non-inferiority margin is 20%|least square means difference|0.89|||||TWO_SIDED|95.0|-14.3|16.07|||||To establish non-inferiority the lower limit of the least square mean difference had to be \> -20%.|||16.07|-14.30|
70923987|NCT05902793|141340032|SUPERIORITY|||||||0.24|||||||ANCOVA|ANCOVA model had fixed effects of treatment arm, center and wound size||||||0.24
70923988|NCT05418296|141340056|SUPERIORITY||||||<|0.46|||||||t-test, 1 sided|||||||<0.46
70923989|NCT05418296|141340057|SUPERIORITY||||||<|0.00314|||||||t-test, 1 sided|||||||<0.00314
70923990|NCT05418296|141340058|SUPERIORITY||||||<|0.066|||||||t-test, 1 sided|||||||<0.066
70923991|NCT05418296|141340059|SUPERIORITY||||||<|0.085|||||||t-test, 1 sided|||||||<0.0850
70923992|NCT05418296|141340060|SUPERIORITY||||||<|0.0716|||||||t-test, 1 sided|||||||<0.0716
70923993|NCT00616967|141340072|SUPERIORITY_OR_OTHER_LEGACY||Pathological complete response rate|0.274|||||TWO_SIDED|95.0|0.169|0.402|||||The Estimation Parameter provided above is for overall pCR for both arms combined. We estimated pCR for each arm separately as well.|Patients were stratified by hormone receptor status and randomly assigned to either arm 1 or 2. This study was designed using Simon's two-stage design for each arm in parallel. Interim analysis of early stopping for futility was conducted for the first 32 patients (16 patients per arm) and the study proceeded as more than 2 patients achieved a pCR in each arm (31 patients per arm). This design had 80% power to detect a 25% pCR rate versus a null rate of 10% with a type I error rate of 0.10.||0.402|0.169|
70923994|NCT00616967|141340072|SUPERIORITY_OR_OTHER_LEGACY||pCR in placebo arm (arm 1)|0.29|||||TWO_SIDED|95.0|0.142|0.48||||||||0.48|0.142|
70923995|NCT00616967|141340072|SUPERIORITY_OR_OTHER_LEGACY||pCR in vorinostat arm (arm 2)|0.258|||||TWO_SIDED|95.0|0.119|0.446||||||||0.446|0.119|
70923996|NCT00616967|141340075|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.1||||0.023|TWO_SIDED|95.0|1.3|22.7|||Regression, Logistic|||The estimates provided are based upon a multivariate analysis using a logistic regression adjusting for hormone receptor status. Patients with ≥50% reduction in SULmax were more likely to achieve a pCR.||22.7|1.3|0.023
70923997|NCT05059262|141340084|SUPERIORITY||Difference in ORR|39.0|||<|0.0001|TWO_SIDED|95.0|28.4|49.6||Stratified by tumor location (lower limb/all other) and region (U.S./non-U.S.) based on Interactive Response Technology (IRT).|Cochran-Mantel-Haenszel||Stratified Mantel-Haenszel with stratification factors based on IRT|||49.6|28.4|<0.0001
70923998|NCT05059262|141340085|SUPERIORITY||Difference in ORR|67.2|||<|0.0001|TWO_SIDED|95.0|57.0|77.3||Stratified by tumor location (lower limb/all other) and region (U.S./non-U.S.) based on IRT.|Cochran-Mantel-Haenszel||Stratified Mantel-Haenszel with stratification factors based on IRT.|||77.3|57.0|<0.0001
70923999|NCT05059262|141340086|SUPERIORITY||LS Mean Difference|14.6||||0.0077|TWO_SIDED|95.0|4.0|25.3||Model included treatment+visit+treatment by visit interaction+stratification factor for region (U.S. versus non-U.S.)+joint type (knee, ankle, or other)+the most impaired ROM baseline value.|Mixed model repeated measures|||||25.3|4.0|0.0077
70924000|NCT05059262|141340087|SUPERIORITY||LS Mean Difference|3.3||||0.0007|TWO_SIDED|95.0|1.4|5.2||Model included treatment+visit+treatment by visit interaction+stratification factor for region (U.S. versus non-U.S.) and tumor location (lower limb/all other) based on IRT+PROMIS-PF baseline value.|Mixed model repeated measures|||||5.2|1.4|0.0007
70924001|NCT05059262|141340088|SUPERIORITY||LS Mean Difference|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.1||Model included treatment+visit+treatment by visit interaction+stratification factor for region (U.S. versus non-U.S.) and tumor location (lower limb/all other) based on IRT+Worst Stiffness NRS baseline value.|Mixed model repeated measures|||||-1.1|-2.5|<0.0001
70924002|NCT05059262|141340089|SUPERIORITY||LS Mean Difference|7.4||||0.0155|TWO_SIDED|95.0|1.4|13.4||Model included treatment+visit+treatment by visit interaction+stratification factor for region (U.S. versus non-U.S.) and tumor location (lower limb/all other) based on IRT+VAS baseline value.|Mixed model repeated measures|||||13.4|1.4|0.0155
71000455|NCT01125293|141506972|OTHER|||||||0.69|||||||Two stage design, exact method|||In a two-stage Simon design, a VGPR or better rate of at least 18% is considered promising versus a 5% or less rate. In stage 1, if 1 or fewer of 23 evaluable participants achieve VGPR, the regimen is considered non-promising else continue with 24 more patients enrolled. If \</=4 of 47 evaluable patients have VGPR or better, the regimen is considered non-promising. If \>/=5, then the regimen is considered promising for further study. With this design, there is 90% power and 1-sided 10% alpha.|The study did not continue to stage 2 given 1 VGPR or better response was observed in 23 evaluable participants in stage 1.|||0.69
71000456|NCT01367860|141506979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.89|STANDARD_ERROR_OF_MEAN|1.06||0.05|TWO_SIDED|95.0|-4.05|0.26|||t-test, 2 sided|||||0.26|-4.05|0.05
71000457|NCT01367860|141506980|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
71000458|NCT01367860|141506981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.9|<|0.05|TWO_SIDED|95.0|-2.21|1.43|||t-test, 2 sided|||||1.43|-2.21|<0.05
71042122|NCT01560819|141593659|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||Wilcoxon signed rank test|||A power calculation was not done for this pilot study. Changes in PUCAI post-treatment were compared with baseline using the Wilcoxon signed rank test. P value \<0.05 was considered statistically significant.||||0.03
71042123|NCT01976728|141593668|SUPERIORITY|The hypotheses were tested using a stratified one-sided Fisher's exact test in the FAS including the randomization scheme as the stratification factor.||||||0.012||||||The SAS PROC FREQ with permutation-based Cochran-Mantel-Haenszel test with exact p-value derived from all possible permutations was employed for the calculation of p-value for the stratified Fisher's exact test.|Fisher Exact|The success threshold at each analysis corresponded to a nominal p-value \<0.0130 to maintain an overall one-sided type I error rate of 0.025.||The primary efficacy analysis compared the pooled ovulation rate of the LutrePulse 15 μg and 20 μg group to placebo.||||0.0120
71042124|NCT01976728|141593669|SUPERIORITY|The hypotheses were tested using a stratified one-sided Fisher's exact test in the FAS including the randomization scheme as the stratification factor.||||||0.0553||||||The SAS PROC FREQ with permutation-based Cochran-Mantel-Haenszel test with exact p-value derived from all possible permutations was employed for the calculation of p-value for the stratified Fisher's exact test.|Fisher Exact|The success threshold at each analysis corresponded to a nominal p-value \<0.0130 to maintain an overall one-sided type I error rate of 0.025.||P4 levels of the pooled LutrePulse 15 μg and 20 μg group were compared to placebo.||||0.0553
71042125|NCT01976728|141593670|SUPERIORITY|The hypotheses was tested using a stratified one-sided Fisher's exact test in the FAS including the randomization scheme as the stratification factor.||||||0.0383||||||The SAS PROC FREQ with permutation-based Cochran-Mantel-Haenszel test with exact p-value derived from all possible permutations was employed for the calculation of p-value for the stratified Fisher's exact test.|Fisher Exact|The success threshold at each analysis corresponded to a nominal p-value \<0.0130 to maintain an overall one-sided type I error rate of 0.025.||Clinical pregnancy rates of the pooled LutrePulse 15 μg and 20 μg group were compared to placebo.||||0.0383
71042126|NCT01976728|141593671|SUPERIORITY|The hypotheses were tested using a stratified one-sided Fisher's exact test in the FAS including the randomization scheme as the stratification factor.||||||0.0246||||||The SAS PROC FREQ with permutation-based Cochran-Mantel-Haenszel test with exact p-value derived from all possible permutations was employed for the calculation of p-value for the stratified Fisher's exact test.|Fisher Exact|The success threshold at each analysis corresponded to a nominal p-value \<0.0130 to maintain an overall one-sided type I error rate of 0.025.||Biochemical pregnancy rates of the pooled LutrePulse 15 μg and 20 μg group were compared to placebo.||||0.0246
71042127|NCT01976728|141593672|SUPERIORITY|The hypotheses were tested using a stratified one-sided Fisher's exact test in the FAS including the randomization scheme as the stratification factor.||||||0.0011||||||The SAS PROC FREQ with permutation-based Cochran-Mantel-Haenszel test with exact p-value derived from all possible permutations was employed for the calculation of p-value for the stratified Fisher's exact test.|Fisher Exact|The success threshold at each analysis corresponded to a nominal p-value \<0.0130 to maintain an overall one-sided type I error rate of 0.025.||LH surge detection of the pooled LutrePulse 15 μg and 20 μg group were compared to placebo.||||0.0011
71042128|NCT01976728|141593673|SUPERIORITY|||||||0.1344||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 10: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.1344
71042129|NCT01976728|141593673|SUPERIORITY|||||||0.2726||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 10: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.2726
71042130|NCT01976728|141593673|SUPERIORITY|||||||0.3173||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 10: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.3173
71042131|NCT01976728|141593673|SUPERIORITY|||||||0.1275||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 12: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.1275
71000459|NCT01367860|141506982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|1.01|<|0.05|TWO_SIDED|95.0|-2.76|1.33|||t-test, 2 sided|||||1.33|-2.76|<0.05
71000460|NCT01367860|141506984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|1.13|<|0.05|TWO_SIDED|95.0|-2.58|2.01|||t-test, 2 sided|||||2.01|-2.58|<0.05
71000461|NCT01367860|141506985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02|STANDARD_ERROR_OF_MEAN|1.14|<|0.05|TWO_SIDED|95.0|-1.3|3.3|||t-test, 2 sided|||||3.3|-1.3|<0.05
70924003|NCT05059262|141340090|SUPERIORITY||Difference in responder rate|26.2||||0.0056|TWO_SIDED|95.0|9.5|42.8||Stratified by tumor location (lower limb/all other) and region (U.S./non-U.S.) based on IRT.|Cochran-Mantel-Haenszel||Stratified Mantel-Haenszel with stratification factors based on IRT.|||42.8|9.5|0.0056
70924004|NCT04501861|141340108|EQUIVALENCE|Compare mPAP-to-MAP ratio between patients who received norepinephrine versus vasopressin intraoperatively. Post intervention measurements will be recorded after protamine administration until end of chest closure.|Mean Difference (Final Values)|0.01||||0.53|TWO_SIDED|95.0|-0.043|0.022|||Mixed Models Analysis|||||0.022|-0.043|0.53
71000462|NCT01367860|141506986|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|2.77|<|0.05|TWO_SIDED|95.0|-2.36|8.8|||t-test, 2 sided|||||8.8|-2.36|<0.05
71000463|NCT01367860|141506987|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|3.3|<|0.05|TWO_SIDED|95.0|-4.4|8.9|||t-test, 2 sided|||||8.9|-4.4|<0.05
71000464|NCT01367860|141506988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|3.6|<|0.05|TWO_SIDED|95.0|-7.15|7.55|||t-test, 2 sided|||||7.55|-7.15|<0.05
71000465|NCT01367860|141506989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|3.65|<|0.05|TWO_SIDED|95.0|-7.14|7.67|||t-test, 2 sided|||||7.67|-7.14|<0.05
71000466|NCT01367860|141506990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|3.18|<|0.05|TWO_SIDED|95.0|-8.16|4.76|||t-test, 2 sided|||||4.76|-8.16|<0.05
71000467|NCT01367860|141506991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67|STANDARD_ERROR_OF_MEAN|0.88|<|0.05|TWO_SIDED|95.0|-0.12|3.46|||t-test, 2 sided|||||3.46|-0.12|<0.05
71000468|NCT01367860|141506992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|1.09|<|0.05|TWO_SIDED|95.0|-2.0|2.4|||t-test, 2 sided|||||2.4|-2|<0.05
71000469|NCT01367860|141506993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|1.08|<|0.05|TWO_SIDED|95.0|-2.55|1.85|||t-test, 2 sided|||||1.85|-2.55|<0.05
71100567|NCT02732145|141709674|EQUIVALENCE|Question: Is there a difference in the duration of vulvar complaints for more than six months among patients with vulvar dermatosis and vulvodynia?||||||0.7241|||||||Chi-squared|||Parameter: The difference in the duration of vulvar complaints for more than six months among patients with vulvar dermatosis or vulvodynia.||||0.7241
71000470|NCT01367860|141506994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|1.11|<|0.05|TWO_SIDED|95.0|-2.29|2.23|||t-test, 2 sided|||||2.23|-2.29|<0.05
71100568|NCT02732145|141709675|EQUIVALENCE|Question: Is there a difference in the sexual activity among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the sexual activity among patients from different groups.||||0.0000
70924005|NCT04501861|141340108|EQUIVALENCE|Compare mPAP-to-MAP ratio between patients who with preop PH received norepinephrine versus vasopressin intraoperatively. Post intervention measurements will be recorded after protamine administration until end of chest closure. The number of patients in norepinephrine group is 52 and in vasopressin group is 40. The significance level was 0.05 for all analyses. All tests were 2-sided. Interactions were considered significant when the interaction P was \< 0.10.|Mean Difference (Final Values)|-0.022||||0.26|TWO_SIDED|95.0|-0.061|0.016|||Mixed Models Analysis|||mPAP-to-MAP ratio was compared between patients with pre-existing pulmonary hypertension of use of vasopressin and norepinephrine. Preoperative pulmonary arterial hypertension was defined by using the cut-off value of 25 mmHg for the time-weighted average mPAP, i.e., time weighted average mPAP \< 25 mmHg indicated absence of preoperative pulmonary arterial hypertension; otherwise, presence of preoperative pulmonary hypertension.||0.016|-0.061|0.26
71000471|NCT01367860|141506995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|1.17|<|0.05|TWO_SIDED|95.0|-1.67|3.08|||t-test, 2 sided|||||3.08|-1.67|<0.05
71000472|NCT01270958|141507000|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71000473|NCT01270958|141507001|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71000474|NCT01270958|141507002|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71000475|NCT01270958|141507003|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71000476|NCT01270958|141507004|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71000477|NCT01270958|141507005|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71000478|NCT01270958|141507006|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71000479|NCT01270958|141507007|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71000480|NCT01270958|141507008|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||<0.01
71000481|NCT01270958|141507009|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71000482|NCT01270958|141507010|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71000483|NCT01270958|141507011|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71000484|NCT01270958|141507012|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71000485|NCT01270958|141507013|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71000486|NCT01270958|141507014|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71000487|NCT01270958|141507015|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71000488|NCT01270958|141507016|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71000489|NCT01270958|141507017|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71000490|NCT01270958|141507018|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71100569|NCT02732145|141709675|EQUIVALENCE|Question: Is there a difference in the frequency of dyspareunia as a cause of sexual inactivity among patients from different groups?||||||0.0006|||||||Chi-squared|||Parameter: The difference in the frequency of dyspareunia as a cause of sexual inactivity among patients from different groups.||||0.0006
70924006|NCT04501861|141340108|EQUIVALENCE|Compare mPAP-to-MAP ratio between patients who without preop PH received norepinephrine versus vasopressin intraoperatively. Post intervention measurements will be recorded after protamine administration until end of chest closure. The number of patients in norepinephrine group is 31 and in vasopressin group is 29. The significance level was 0.05 for all analyses. All tests were 2-sided. Interactions were considered significant when the interaction P was \< 0.10.|Mean Difference (Final Values)|-0.0035||||0.88|TWO_SIDED|95.0|-0.05|0.043|||Mixed Models Analysis|||mPAP-to-MAP ratio was compared between patients without pre-existing pulmonary hypertension of use of vasopressin and norepinephrine. Preoperative pulmonary arterial hypertension was defined by using the cut-off value of 25 mmHg for the time-weighted average mPAP, i.e., time weighted average mPAP \< 25 mmHg indicated absence of preoperative pulmonary arterial hypertension; otherwise, presence of preoperative pulmonary hypertension.||0.043|-0.05|0.88
70924007|NCT04501861|141340109|EQUIVALENCE|Imbalanced confounders such as female, coronary artery disease, preoperative ejection fraction, surgery type, primary or repeat surgery, and bypass time were additionally adjusted. A different inverse probability of treatment weighting was fit for secondary analysis and a linear mixed regression model with random intercept to account for intra-week correlation to estimate the effect of norepinephrine on right ventricular free wall strain using the new obtained stabilized weights|Mean Difference (Final Values)|-1.8||||0.37|TWO_SIDED|95.0|-6.0|2.3|||Mixed Models Analysis|||||2.3|-6.0|0.37
70924008|NCT04501861|141340109|EQUIVALENCE|We examined the effect of norepinephrine versus vasopressin on right ventricular free wall strain by considering patients who have preoperative pulmonary hypertension. The number of patients in norepinephrine group is 34 and in vasopressin group is 28. The significance level was 0.05 for all analyses. All tests were 2-sided. The significance levels of subgroup analyses were not corrected for multiple comparisons. Interactions were considered significant when the interaction P was \< 0.10.|Mean Difference (Final Values)|-2.1||||0.39|TWO_SIDED|95.0|-7.1|2.8|||Mixed Models Analysis|||RV free wall strain compare between patients with pre-existing pulmonary hypertension of use of vasopressin and norepinephrine. Preoperative pulmonary arterial hypertension was defined by using the cut-off value of 25 mmHg for the time-weighted average mPAP, i.e., time weighted average mPAP \< 25 mmHg indicated absence of preoperative pulmonary arterial hypertension; otherwise, presence of preoperative pulmonary hypertension;||2.8|-7.1|0.39
71000491|NCT02481596|141507035|SUPERIORITY|||||||0.045||||||Beta=.083. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||3 months. Multiply imputed data (m=20) using chained equations.||||.045
71000492|NCT02481596|141507035|SUPERIORITY|||||||0.006||||||Beta=.126. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||6 months. Multiply imputed data (m=20) using chained equations.||||.006
71000493|NCT02481596|141507036|SUPERIORITY|||||||0.518||||||Beta=.031. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||3 months. Multiply imputed data (m=20) using chained equations.||||.518
71100570|NCT02732145|141709675|EQUIVALENCE|Question: Is there a difference in the frequency of sexual inactivity due to dyspareunia and lack of a sexual partner among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the frequency of sexual inactivity due to dyspareunia and lack of a sexual partner among patients from different groups.||||0.0000
71000494|NCT02481596|141507036|SUPERIORITY|||||||0.092||||||Beta=.092. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||6 months. Multiply imputed data (m=20) using chained equations.||||.092
71000495|NCT02481596|141507037|SUPERIORITY|||||||0.53||||||Beta=-.027. Threshold p\<.05|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||3 months. Multiply imputed data (m=20) using chained equations||||.53
71100571|NCT02732145|141709676|EQUIVALENCE|Question: Is there a difference in the frequency of dyspareunia among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the frequency of dyspareunia among patients from different groups.||||0.0000
71100572|NCT02732145|141709676|EQUIVALENCE|Parameter: The difference in the degree of dyspareunia (Marinoff Index) among sexually active patients with vulvodynia or vulvar dermatosis who had dyspareunia.||||||0.2999|||||||Chi-squared|||Parameter: The difference in the degree of dyspareunia (Marinoff Index) among sexually active patients with vulvodynia or vulvar dermatosis who had dyspareunia.||||0.2999
71100573|NCT02732145|141709677|EQUIVALENCE|Question: Is there a difference in the incidence of the frequency of vulvar discomfort provoked through the intercourse in patients with vulvodynia and vulvar dermatosis?||||||0|||||||Chi-squared|||Parameter: The difference in the frequency of vulvar discomfort provoked through the intercourse in patients with vulvodynia and vulvar dermatosis.||||0.0000
71000496|NCT02481596|141507037|SUPERIORITY|||||||0.41||||||Beta=-.037. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||6 months. Multiply imputed data (m=20) using chained equations.||||.41
71000497|NCT02481596|141507038|SUPERIORITY|||||||0.024||||||Beta=.088. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots); also adjusted for harmful involvement subscale of FIAD due to suppression effect.||3 months. Multiply imputed data (m=20) using chained equations.||||.024
71000498|NCT02481596|141507038|SUPERIORITY|||||||0.003||||||Beta=.128. Threshold p\<.05|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots); also adjusted for harmful involvement subscale of FIAD due to suppression effect.||6 months. Multiply imputed data (m=20) using chained equations.||||.003
71000499|NCT02481596|141507039|SUPERIORITY|||||||0.001||||||Beta=-.133. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots); also adjusted for helpful involvement subscale of FIAD due to suppression effect.||3 months. Multiply imputed data (m=20) using chained equations.||||.001
71000500|NCT02481596|141507039|SUPERIORITY|||||||0.012||||||Beta=-.115. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots); also adjusted for helpful involvement subscale of FIAD due to suppression effect.||6 months. Multiply imputed data (m=20) using chained equations.||||.012
71000501|NCT02481596|141507040|SUPERIORITY|||||||0.015||||||Beta=.114. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||3 months. Multiply imputed data (m=20) using chained equations.||||.015
71000502|NCT02481596|141507040|SUPERIORITY|||||||0.034||||||Beta=.101. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||6 months. Multiply imputed data (m=20) using chained equations.||||.034
71000503|NCT02925312|141507042|SUPERIORITY|||||||0.05|||||||McNemar|||The study was powered to detect a difference of 0.5 in the change in HbA1c with SD=2 with 80% power at alpha=0.05 with a sample size of 128 in each group (paired t-test). Differences in patient characteristics and the unadjusted differences in the outcome measures between the intervention and control groups were tested using linear mixed models, McNemar tests and conditional logistic models due to matching.||||0.05
71100574|NCT02732145|141709677|EQUIVALENCE|Question: Is there a difference in the frequency of vulvar discomfort provoked through the penetration in patients with vulvodynia and vulvar dermatosis?||||||0.0347|||||||Chi-squared|||Parameter: The difference in the frequency of vulvar discomfort provoked through the penetration in patients with vulvodynia and vulvar dermatosis.||||0.0347
71000504|NCT03205982|141507065|EQUIVALENCE|If the difference (between treatment and control arm) is greater than the minimal clinically important difference (MCID), we consider the treatment arm is different from the control arm. MCID is calculated as 0.25-0.5\* standard deviation (SD). Conversely, the equivalence margin is the biggest difference (between 2 arms) to be considered no difference between 2 arms. Therefore, the equivalence margin should be smaller than MCID, i.e., it should be smaller than the smallest possible MCID.|Odds Ratio (OR)|0.9943|STANDARD_ERROR_OF_MEAN|0.0005|<|0.0001|TWO_SIDED|95.0|0.993|0.995|||Mixed Models Analysis|generalized linear mixed model with logit link (logistic model)||Compares difference in adherence changes between Intervention and Control arms||0.995|0.993|<0.0001
71000505|NCT01293084|141507089|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.2||||0.62|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.62
71000506|NCT01293084|141507090|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.3||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.32
71000507|NCT01041404|141507150|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.0002|TWO_SIDED|95.0|0.59|0.85|||Log Rank|||||0.85|0.59|0.0002
71100575|NCT02732145|141709677|EQUIVALENCE|Question: Is there a difference in the frequency of vulvar discomfort aggravated through sexual intercourse in patients with vulvodynia and vulvar dermatosis?||||||0.7068|||||||Chi-squared|||Parameter: The difference in the frequency of vulvar discomfort aggravated through sexual intercourse in patients with vulvodynia and vulvar dermatosis.||||0.7068
71100576|NCT02732145|141709677|EQUIVALENCE|Question: Is there a difference in the frequency of vulvar discomfort aggravated after sexual intercourse in patients with vulvodynia and vulvar dermatosis?||||||0.0025|||||||Chi-squared|||Parameter: The difference in the frequency of vulvar discomfort aggravated after sexual intercourse in patients with vulvodynia and vulvar dermatosis.||||0.0025
71000508|NCT01041404|141507152|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.0003|TWO_SIDED|95.0|0.58|0.85|||Log Rank|||||0.85|0.58|0.0003
71000509|NCT01041404|141507153|SUPERIORITY_OR_OTHER||Difference in Response Rates|12.8||||0.0017|TWO_SIDED|95.0|4.7|20.9|||Chi-squared|||||20.9|4.7|0.0017
71000510|NCT01041404|141507155|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.4|0.73|||Log Rank|||||0.73|0.40|<0.0001
71000511|NCT01041404|141507156|SUPERIORITY_OR_OTHER||Difference in Clinical Benefit Rate|9.6||||0.0081|TWO_SIDED|95.0|2.4|16.9|||Chi-squared|||||16.9|2.4|0.0081
71000512|NCT01041404|141507156|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66|||||TWO_SIDED|95.0|1.14|2.41||||||||2.41|1.14|
71000513|NCT01041404|141507157|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.0046|TWO_SIDED|95.0|0.6|0.91|||Log Rank|||||0.91|0.60|0.0046
71042132|NCT01976728|141593673|SUPERIORITY|||||||0.1088||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 12: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.1088
71000514|NCT02088541|141507202|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.4221|TWO_SIDED|95.0|0.79|1.75|||Log Rank|||||1.75|0.79|0.4221
71000515|NCT02088541|141507203|SUPERIORITY|||||||0.9464|||||||Log Rank|||||||0.9464
71000516|NCT02088541|141507204|SUPERIORITY|||||||0.0986|||||||Cochran-Mantel-Haenszel|||||||0.0986
71000517|NCT02088541|141507206|SUPERIORITY|||||||0.0844|||||||Cochran-Mantel-Haenszel|||||||0.0844
71000518|NCT03170258|141507224|OTHER|||||||0.0015|||||||t-test, 2 sided|One-sample 2-sided t-test against a mean of 0 used to evaluate the main effect of VTA activation during neurofeedback.||||||0.0015
71000519|NCT03170258|141507225|OTHER||||||>|0.1|||||||t-test, 1 sided|One-sample t-test against 0 for the ratio of Beta to Theta power.||||||>0.10
71000520|NCT01391468|141507263|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
71000521|NCT01391468|141507264|SUPERIORITY_OR_OTHER|||||||0.744|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.744
71000522|NCT01391468|141507265|SUPERIORITY_OR_OTHER|||||||0.0042|TWO_SIDED|||||Only the probiotics group arrived at the reported p-value after 6 months|Wilcoxon (Mann-Whitney)|||||||0.0042
71000523|NCT01391468|141507266|SUPERIORITY_OR_OTHER|||||||0.0099|TWO_SIDED|||||Only the probiotics group arrived at the reported p-value after 6 months|Wilcoxon (Mann-Whitney)|||||||0.0099
71000524|NCT00511108|141507291|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.7||||0.002||95.0|-48.7|-10.6|||ANCOVA|Model terms: treatment, prior diabetes pharmacotherapy (yes or no), and baseline value as a covariate||||-10.6|-48.7|0.002
71100577|NCT02732145|141709678|SUPERIORITY|Question: Is there a difference in the frequency of use of vaginal tampon among patients with vulvodynia and vulvar dermatosis?||||||0|||||||Chi-squared|||Parameter: The difference in the frequency of use of vaginal tampon among patients with vulvodynia and vulvar dermatosis.||||0.0000
71000525|NCT00511108|141507292|SUPERIORITY_OR_OTHER||Geometric Mean Difference|73.8|||<|0.001||95.0|44.2|104.4|||ANCOVA|Model terms: treatment, prior diabetes pharmacotherapy (yes or no), and log-scaled baseline value as a covariate|The outcome was analyzed by ANCOVA on the log scale. Results have been back-transformed to the original scale.|||104.4|44.2|<0.001
71000526|NCT00511108|141507293|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-407.8|||<|0.001||95.0|-513.4|-302.1|||ANCOVA|Model terms: treatment, prior diabetes pharmacotherapy (yes or no), and baseline value as a covariate||||-302.1|-513.4|<0.001
71000527|NCT01392742|141507331|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for RVR at Week 4.||||0.000
71000528|NCT01392742|141507331|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||Regression, Linear|||Binary logistic regression for gender at Week 4.||||0.018
71000529|NCT01392742|141507331|SUPERIORITY_OR_OTHER|||||||0.062|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for liver fibrosis at Week 4.||||0.062
71000530|NCT01392742|141507331|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for HCV genotype at Week 4.||||0.050
71000531|NCT01392742|141507331|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for height at Week 4.||||0.001
71000532|NCT01392742|141507331|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for treatment duration at Week 4.||||0.001
71000533|NCT01392742|141507331|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for EVR at Week 12.||||0.037
71000534|NCT01392742|141507331|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for gender at Week 12.||||0.018
71000535|NCT01392742|141507331|SUPERIORITY_OR_OTHER|||||||0.092|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for liver fibrosis at Week 12.||||0.092
71000536|NCT01392742|141507331|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for height at Week 12.||||0.001
71000537|NCT01392742|141507331|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for treatment duration at Week 12.||||0.042
71000538|NCT02911519|141507351|SUPERIORITY||Risk Ratio (RR)|0.95||||0.59|TWO_SIDED|95.0|0.77|1.16|||Mixed Models Analysis||This is intention-to-treat analysis. The Brief Group Psychoeducation is the numerator and the group of Treatment as Usual Only is the denominator for relative risk.|||1.16|0.77|0.59
71000539|NCT02911519|141507352|SUPERIORITY||Risk Ratio (RR)|0.98||||0.73|TWO_SIDED|95.0|0.87|1.1|||Mixed Models Analysis||The Brief Group Psychoeducation is the numerator and the group of Treatment as Usual Only is the denominator for relative risk. This is intention-to-treat analysis.|||1.10|0.87|0.73
71000540|NCT02911519|141507353|SUPERIORITY||Slope|0.01||||0.94|TWO_SIDED|95.0|-0.36|0.39|||Mixed Models Analysis||This is intention-to-treat analysis.|||0.39|-0.36|0.94
71000541|NCT02911519|141507353|SUPERIORITY||Slope|-0.19||||0.3|TWO_SIDED|95.0|-0.57|0.18|||Mixed Models Analysis||This is intention-to-treat analysis.|||0.18|-0.57|0.30
71000542|NCT02911519|141507355|SUPERIORITY||Slope|0.03||||0.61|TWO_SIDED|95.0|-0.1|0.17|||Mixed Models Analysis||This is an intention to treat analysis.|||0.17|-0.10|0.61
71000543|NCT02911519|141507356|SUPERIORITY|This statistical Analysis applies to WHOQOL-BREF 1ST DOMAIN (physical health) in the first row.|Slope|0.04||||0.81|TWO_SIDED|95.0|-0.38|0.3|||Mixed Models Analysis||This is an intention to treat analysis. This statistical Analysis applies to WHOQOL-BREF 1ST DOMAIN (physical health) in the first row.|||0.30|-0.38|0.81
71000544|NCT02911519|141507356|SUPERIORITY|This is an intention to treat analysis. This statistical Analysis applies to WHOQOL-BREF 2ND DOMAIN (psychological) in the second row.|Slope|-0.04||||0.81|TWO_SIDED|95.0|-0.38|0.29|||Mixed Models Analysis||This is an intention to treat analysis.This statistical Analysis applies to WHOQOL-BREF 2ND DOMAIN (psychological) in the second row.|||0.29|-0.38|0.81
71000545|NCT02911519|141507356|SUPERIORITY|This statistical Analysis applies to WHOQOL-BREF 3RD DOMAIN (social relationships) in the third row.|Slope|0.16||||0.52|TWO_SIDED|95.0|-0.33|0.65|||Mixed Models Analysis||This is an intention to treat analysis. This statistical Analysis applies to WHOQOL-BREF 3RD DOMAIN (social relationships) in the third row.|||0.65|-0.33|0.52
71000546|NCT02911519|141507356|SUPERIORITY|This statistical Analysis applies to WHOQOL-BREF 4TH DOMAIN (environment) in the fourth row.|Slope|0.19||||0.27|TWO_SIDED|95.0|-0.15|0.53|||Mixed Models Analysis||This is an intention to treat analysis. This statistical Analysis applies to WHOQOL-BREF 4TH DOMAIN (environment) in the fourth row.|||0.53|-0.15|0.27
71000547|NCT02911519|141507357|SUPERIORITY|This analysis applies to SSFB objective domain in the first row.|Slope|-0.01||||0.33|TWO_SIDED|95.0|-0.01|0.01|||Mixed Models Analysis||This is an intention to treat analysis. This analysis applies to SSFB objective domain in the first row.|||0.01|-0.01|0.33
71000548|NCT02911519|141507357|SUPERIORITY|This is an intention to treat analysis. This analysis applies to SSFB subjective domain in the second row.|Slope|-0.01||||0.19|TWO_SIDED|95.0|-0.02|0.01|||Mixed Models Analysis||This is an intention to treat analysis. This analysis applies to SSFB subjective domain in the second row.|||0.01|-0.02|0.19
71000549|NCT02911519|141507358|SUPERIORITY||Slope|0.01||||0.97|TWO_SIDED|95.0|-0.19|0.19|||Mixed Models Analysis||This is an intention to treat analysis.|||0.19|-0.19|0.97
71000550|NCT01444898|141507368|SUPERIORITY_OR_OTHER|||||||0.07|||||||Mixed Models Analysis|||||||.07
71000551|NCT01444898|141507369|SUPERIORITY_OR_OTHER|||||||0.08|||||||Mixed Models Analysis|||||||0.08
71000552|NCT01444898|141507370|SUPERIORITY_OR_OTHER|||||||0.8|||||||Mixed Models Analysis|||||||.8
71000553|NCT01444898|141507371|SUPERIORITY_OR_OTHER|||||||0.04|||||||Mixed Models Analysis|||||||.04
71000554|NCT01444898|141507372|SUPERIORITY_OR_OTHER|||||||0.8|||||||Mixed Models Analysis|||||||.8
71000555|NCT01444898|141507373|SUPERIORITY_OR_OTHER|||||||0.2|||||||Mixed Models Analysis|||||||.2
71000556|NCT01444898|141507374|SUPERIORITY_OR_OTHER|||||||0.2|||||||Mixed Models Analysis|||||||.2
71000557|NCT01444898|141507375|SUPERIORITY_OR_OTHER|||||||0.04|||||||Mixed Models Analysis|||||||.04
71000558|NCT01444898|141507376|SUPERIORITY_OR_OTHER|||||||0.004|||||||Mixed Models Analysis|||||||.004
71000559|NCT02580591|141507378|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|99.0|-0.46|-0.11|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.11|-0.46|<0.0001
71000560|NCT02580591|141507378|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.6|-0.3|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.30|-0.60|<0.0001
71000561|NCT02580591|141507378|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.68|-0.37|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.37|-0.68|<0.0001
71000562|NCT02580591|141507379|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|95.0|-0.4|-0.14|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.14|-0.40|
71000563|NCT02580591|141507379|SUPERIORITY||Median Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.59|-0.28|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.28|-0.59|<0.0001
71000564|NCT02580591|141507379|SUPERIORITY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.66|-0.35|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.35|-0.66|<0.0001
71000565|NCT02580591|141507380|SUPERIORITY||Adjusted Rate Ratio (%)|0.94|||||TWO_SIDED|95.0|0.673|1.314|||Negative binomial model||Empagliflozin 2.5 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For Week 5 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.314|0.673|
71000566|NCT02580591|141507380|SUPERIORITY||Adjusted Rate Ratio (%)|1.202||||0.2752|TWO_SIDED|97.75|0.818|1.766|||Negative binomial model||Empagliflozin 10 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For Week 5 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.766|0.818|0.2752
71042133|NCT01976728|141593673|SUPERIORITY|||||||0.2374||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 12: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.2374
71042134|NCT01976728|141593673|SUPERIORITY|||||||0.0796||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 15: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test||||0.0796
71042135|NCT01976728|141593673|SUPERIORITY|||||||0.1757||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 15: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test||||0.1757
71100578|NCT02732145|141709678|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort due to the use of vaginal tampon in symptomatic patients, who use vaginal tampons?||||||0.6552|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort due to the use of vaginal tampon in symptomatic patients, who use vaginal tampons.||||0.6552
71100579|NCT02732145|141709678|SUPERIORITY|Question: Is there a difference in the frequency of cycling among patients with vulvodynia and vulvar dermatosis?||||||0.0002|||||||Chi-squared|||Parameter: The difference in the frequency of cycling among patients with vulvodynia and vulvar dermatosis.||||0.0002
71100580|NCT02732145|141709678|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort due to the cycling in symptomatic patients, who ride a bicycle?||||||0.2877|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort due to the cycling in symptomatic patients, who ride a bicycle.||||0.2877
71000567|NCT02580591|141507380|SUPERIORITY||Adjusted Rate Ratio (%)|1.02||||0.9077|TWO_SIDED|97.75|0.693|1.501|||Negative binomial model||Empagliflozin 25 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For Week 5 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.501|0.693|0.9077
71000568|NCT02580591|141507380|SUPERIORITY||Adjusted Rate Ratio (%)|0.932|||||TWO_SIDED|95.0|0.682|1.274|||Negative binomial model|||For Week 1 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.274|0.682|
71000569|NCT02580591|141507380|SUPERIORITY||Adjusted Rate Ratio (%)|1.258||||0.1438|TWO_SIDED|95.0|0.925|1.713||This is a nominal p-value.|Negative binomial model||Empagliflozin 10 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For Week 1 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.713|0.925|0.1438
71042136|NCT01976728|141593673|SUPERIORITY|||||||0.0584||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 15: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.0584
71042137|NCT01976728|141593673|SUPERIORITY|||||||0.3711||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 18: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.3711
71042138|NCT01976728|141593673|SUPERIORITY|||||||0.0143||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 18: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.0143
70924009|NCT04501861|141340109|EQUIVALENCE|We're going to explore the interaction between preoperative pulmonary arterial hypertension status and treatment group by equivalence analysis. The number of patients in norepinephrine group is 22 and in vasopressin group is 18.The significance level was 0.05 for all analyses. All tests were 2-sided. The significance levels of subgroup analyses were not corrected for multiple comparisons. Interactions were considered significant when the interaction P was \< 0.10.|Mean Difference (Final Values)|-1.5||||0.63|TWO_SIDED|95.0|-7.6|4.6|||Mixed Models Analysis|||"We examined the effect of norepinephrine versus vasopressin on right ventricular free wall strain by separately considering patients who did not have preoperative pulmonary hypertension.~Preoperative pulmonary arterial hypertension was defined by using the cut-off value of 25 mmHg for the time-weighted average mPAP, i.e., time weighted average mPAP \< 25 mmHg indicated absence of preoperative pulmonary arterial hypertension; otherwise, presence of preoperative pulmonary hypertension."||4.6|-7.6|0.63
71000570|NCT02580591|141507380|SUPERIORITY||Adjusted Rate Ratio (%)|1.051||||0.7543|TWO_SIDED|95.0|0.771|1.433||This is a nominal p-value.|Negative binomial model||Empagliflozin 25 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For Week 1 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.433|0.771|0.7543
70924010|NCT03281291|141340166|OTHER||Vaccine Efficacy|29.7|||||TWO_SIDED|95.0|14.7|42.1|||Regression, Cox||VE = 1 minus the Hazard Ratio (HR). HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy (VE) in the TVC against the first new genotypic infection, between enrollment and Month 20 visit, for R012-20 Group vs Control Group.||42.1|14.7|
70924011|NCT03281291|141340166|OTHER||Vaccine Efficacy|31.2|||||TWO_SIDED|95.0|16.4|43.3|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 20 visit, for R012-14-mD Group vs Control Group.||43.3|16.4|
70924012|NCT03281291|141340166|OTHER||Vaccine Efficacy|24.6|||||TWO_SIDED|95.0|9.0|37.6|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 20 visit, for Fx012-14-mFxD Group vs Control Group.||37.6|9.0|
70924013|NCT03281291|141340166|OTHER||Vaccine Efficacy|28.8|||||TWO_SIDED|95.0|13.9|41.1|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 20 visit, for Fx017-mFxD Group vs Control Group.||41.1|13.9|
70924014|NCT03281291|141340167|OTHER||Vaccine Efficacy|42.8|||||TWO_SIDED|95.0|30.7|52.8|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 2.5 and 14, for R012-20 + R012-14-mD Pooled Group vs Control Group.||52.8|30.7|
71100581|NCT02732145|141709678|SUPERIORITY|Question: Is there a difference in the frequency of wearing tight clothes among patients with vulvar dermatosis and vulvodynia?||||||0.0001|||||||Chi-squared|||Parameter: The difference in the frequency of wearing tight clothes among patients with vulvar dermatosis and vulvodynia.||||0.0001
70924015|NCT03281291|141340167|OTHER||Vaccine Efficacy|36.7|||||TWO_SIDED|95.0|21.2|49.2|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 2.5 and 14, for Fx012-14-mFxD Group vs Control Group.||49.2|21.2|
71000571|NCT02580591|141507381|SUPERIORITY||Mean Difference (Final Values)|-1.76|||||TWO_SIDED|95.0|-2.32|-1.2|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline weight, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline weight by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-1.20|-2.32|
70924016|NCT03281291|141340167|OTHER||Vaccine Efficacy|41.4|||||TWO_SIDED|95.0|26.7|53.1|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 7.5 and 19, for Fx017-mFxD Group vs Control Group.||53.1|26.7|
70924017|NCT03281291|141340168|OTHER||Vaccine Efficacy|29.6|||||TWO_SIDED|95.0|15.4|41.5|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 32 visit, for R012-20 Group vs Control Group.||41.5|15.4|
70924018|NCT03281291|141340168|OTHER||Vaccine Efficacy|30.6|||||TWO_SIDED|95.0|16.6|42.2|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 32 visit, for R012-14-mD Group vs Control Group.||42.2|16.6|
70924019|NCT03281291|141340168|OTHER||Vaccine Efficacy|27.4|||||TWO_SIDED|95.0|13.1|39.4|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 32 visit, for Fx012-14-mFxD Group vs Control Group.||39.4|13.1|
70924020|NCT03281291|141340168|OTHER||Vaccine Efficacy|26.3|||||TWO_SIDED|95.0|11.9|38.3|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 32 visit, for Fx017-mFxD Group vs Control Group.||38.3|11.9|
70924021|NCT03281291|141340169|OTHER||Vaccine Efficacy|41.8|||||TWO_SIDED|95.0|28.6|52.5|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 2.5 and 26, for R012-20 Group vs Control Group.||52.5|28.6|
70924022|NCT03281291|141340169|OTHER||Vaccine Efficacy|39.9|||||TWO_SIDED|95.0|26.8|50.6|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 2.5 and 26, for R012-14-mD Group vs Control Group.||50.6|26.8|
70924023|NCT03281291|141340169|OTHER||Vaccine Efficacy|33.6|||||TWO_SIDED|95.0|19.3|45.3|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 2.5 and 26, for Fx012-14-mFxD Group vs Control Group.||45.3|19.3|
70924024|NCT03281291|141340169|OTHER||Vaccine Efficacy|40.6|||||TWO_SIDED|95.0|27.2|51.5|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 7.5 and 31, for Fx017-mFxD Group vs Control Group.||51.5|27.2|
70924025|NCT03281291|141340170|OTHER||Additive difference|-1.5|||||TWO_SIDED|95.0|-1.979|-1.022|||Wald Test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 20 visit, for R012-20 Group vs Control Group.||-1.022|-1.979|
70924026|NCT03281291|141340170|OTHER||Additive difference|-1.544|||||TWO_SIDED|95.0|-2.027|-1.061|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 20 visit, for R012-14-mD Group vs Control Group.||-1.061|-2.027|
70924027|NCT03281291|141340170|OTHER||Additive difference|-1.575|||||TWO_SIDED|95.0|-2.065|-1.085|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 20 visit, for Fx012-14-mFxD Group vs Control Group.||-1.085|-2.065|
70924028|NCT03281291|141340170|OTHER||Additive difference|-1.11|||||TWO_SIDED|95.0|-1.635|-0.586|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 20 visit, for Fx017-mFxD Group vs Control Group.||-0.586|-1.635|
71000572|NCT02580591|141507381|SUPERIORITY||Mean Difference (Final Values)|-3.04|||<|0.0001|TWO_SIDED|99.75|-3.91|-2.18|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline weight, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline weight by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-2.18|-3.91|<0.0001
71042139|NCT01976728|141593673|SUPERIORITY|||||||0.006||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 18: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.0060
70924029|NCT03281291|141340171|OTHER||Additive difference|-0.769|||||TWO_SIDED|95.0|-1.068|-0.469|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 2.5 to 14, for R012-20 + R012-14-mD Pooled Group vs Control Group.||-0.469|-1.068|
70924030|NCT03281291|141340171|OTHER||Additive difference|-0.786|||||TWO_SIDED|95.0|-1.133|-0.439|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 2.5 to 14, for Fx012-14-mFxD groups vs Control Group.||-0.439|-1.133|
70924031|NCT03281291|141340171|OTHER||Additive difference|-1.275|||||TWO_SIDED|95.0|-1.592|-0.959|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 7.5 to 19, for Fx017-mFxD groups vs Control Group.||-0.959|-1.592|
70924032|NCT03281291|141340172|OTHER||Additive difference|-2.686|||||TWO_SIDED|95.0|-3.448|-1.924|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 32 visit, for R012-20 Group vs Control Group.||-1.924|-3.448|
70924033|NCT03281291|141340172|OTHER||Additive difference|-2.452|||||TWO_SIDED|95.0|-3.217|-1.686|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 32 visit, for R012-14-mD Group vs Control Group.||-1.686|-3.217|
70924034|NCT03281291|141340172|OTHER||Additive difference|-2.585|||||TWO_SIDED|95.0|-3.345|-1.824|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 32 visit, for Fx012-14-mFxD Group vs Control Group.||-1.824|-3.345|
71000573|NCT02580591|141507381|SUPERIORITY||Mean Difference (Final Values)|-3.43|||<|0.0001|TWO_SIDED|99.75|-4.3|-2.57|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline weight, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline weight by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-2.57|-4.30|<0.0001
70924035|NCT03281291|141340172|OTHER||Additive difference|-1.897|||||TWO_SIDED|95.0|-2.726|-1.067|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 32 visit, for Fx017-mFxD Group vs Control Group.||-1.067|-2.726|
70924036|NCT03281291|141340173|OTHER||Additive difference|-1.633|||||TWO_SIDED|95.0|-2.252|-1.015|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 2.5 to 26, for R012-20 group vs Control Group.||-1.015|-2.252|
70924037|NCT03281291|141340173|OTHER||Additive difference|-1.997|||||TWO_SIDED|95.0|-2.601|-1.393|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 2.5 to 26, for R012-14 group vs Control Group.||-1.393|-2.601|
70924038|NCT03281291|141340173|OTHER||Additive difference|-1.776|||||TWO_SIDED|95.0|-2.399|-1.153|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 2.5 to 26, for Fx012-14-mFxD group vs Control Group.||-1.153|-2.399|
71008602|NCT02055976|141525231|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-54.634|STANDARD_ERROR_OF_MEAN|3.549|<|0.001|TWO_SIDED|95.0|-61.685|-47.583|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-47.583|-61.685|<0.001
71008603|NCT02055976|141525231|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-59.608|STANDARD_ERROR_OF_MEAN|3.52|<|0.001|TWO_SIDED|95.0|-66.602|-52.614|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-52.614|-66.602|<0.001
70924039|NCT03281291|141340173|OTHER||Additive difference|-1.843|||||TWO_SIDED|95.0|-2.527|-1.158|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 7.5 to 31, for Fx017-mFxD group vs Control Group.||-1.158|-2.527|
70924040|NCT04382898|141340176|SUPERIORITY|||||||0.1041|||||||Fisher Exact|||||||0.1041
70924041|NCT04382898|141340182|SUPERIORITY|||||||0.0541|||||||Binomial test|||||||0.0541
70924042|NCT05229120|141340183|SUPERIORITY||Mean Difference (Final Values)|1.24||||0.124|ONE_SIDED||||||t-test, 1 sided|No adjustments were made. DF = 10.||A single-sided paired-samples t-test comparing k-values at baseline to k-values at follow-up (approximately 4 weeks after baseline assessment) was examined. Given that k-values are typically skewed (and to be consistent with the existing literature) we used a log-k as our outcome variable.||||.124
70924043|NCT05229120|141340184|SUPERIORITY||Mean Difference (Final Values)|1.13||||0.219|TWO_SIDED||||||t-test, 1 sided|No adjustments were made. DF = 14.||Changes in consideration of future consequences (parenting) was evaluated using one-sided paired samples t-tests.||||.219
70924044|NCT05229120|141340185|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.5|TWO_SIDED||||||t-test, 1 sided|No adjustments were made. DF = 5||Performed a one-sided paired samples t-test examining changes in both positive parenting.||||.50
70924045|NCT05229120|141340185|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.187|TWO_SIDED||||||t-test, 1 sided|||Used a one-sided paired samples t-test to examine changes in negative parenting.||||.187
71008604|NCT02055976|141525232|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-43.265|STANDARD_ERROR_OF_MEAN|3.566|<|0.001|TWO_SIDED|95.0|-50.347|-36.183|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-36.183|-50.347|<0.001
71000574|NCT02580591|141507382|SUPERIORITY||Mean Difference (Final Values)|-0.049|||||TWO_SIDED|95.0|-0.069|-0.03|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline total daily insulin dose, baseline estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline total daily insulin dose by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.030|-0.069|
71000575|NCT02580591|141507382|SUPERIORITY||Mean Difference (Final Values)|-0.07|||<|0.0001|TWO_SIDED|99.75|-0.101|-0.039|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline total daily insulin dose, baseline estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline total daily insulin dose by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.039|-0.101|<0.0001
71042140|NCT01976728|141593673|SUPERIORITY|||||||0.1573||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 21: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.1573
71042141|NCT01976728|141593674|SUPERIORITY|||||||0.4142||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 12: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.4142
71042142|NCT01976728|141593674|SUPERIORITY|||||||0.2374||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Number of follicles with a mean diameter ≥18 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.2374
71042143|NCT01976728|141593674|SUPERIORITY|||||||0.2636||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 15: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.2636
71042144|NCT01976728|141593674|SUPERIORITY|||||||0.4795||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 15: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.4795
71000576|NCT02580591|141507382|SUPERIORITY||Mean Difference (Final Values)|-0.091|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|99.75|-0.122|-0.06|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline total daily insulin dose, baseline estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline total daily insulin dose by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.060|-0.122|<0.0001
71000577|NCT02580591|141507383|SUPERIORITY||Median Difference (Final Values)|-2.1|||||TWO_SIDED|95.0|-3.9|-0.2|||Mixed effect Model Repeat MeasurementMix||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For SBP, the model includes baseline SBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline SBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.2|-3.9|
71000578|NCT02580591|141507383|SUPERIORITY||Mean Difference (Final Values)|-3.9|||<|0.0001|TWO_SIDED|99.75|-6.8|-1.1|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For SBP, the model includes baseline SBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, , treatment by visit interaction, baseline SBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-1.1|-6.8|<0.0001
71000579|NCT02580591|141507383|SUPERIORITY||Mean Difference (Final Values)|-3.7|||<|0.0001|TWO_SIDED|99.75|-6.6|-0.9|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For SBP, the model includes baseline SBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline SBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.9|-6.6|<0.0001
71000580|NCT02580591|141507383|SUPERIORITY||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-1.5|0.9|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For DBP, the model includes baseline DBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline DBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||0.9|-1.5|
71000581|NCT02580591|141507383|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.0047|TWO_SIDED|99.75|-3.6|0.1|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For DBP, the model includes baseline DBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, ß, treatment by visit interaction, baseline DBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||0.1|-3.6|0.0047
71000582|NCT02580591|141507383|SUPERIORITY||Mean Difference (Final Values)|-1.4||||0.0202|TWO_SIDED|99.75|-3.3|0.4|||Mixed effect Model Repeat Measurement|||For DBP, the model includes baseline DBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, ß, treatment by visit interaction, baseline DBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||0.4|-3.3|0.0202
71000583|NCT00047853|141507391|OTHER||||||<|0.001|||||||ANOVA|||||||< 0.001
71000584|NCT00047853|141507392|OTHER|||||||9.3e-05|||||||t-test, 2 sided|||||||0.000093
71000585|NCT02443805|141507394|SUPERIORITY||||||<|0.0001||||||Source Model: Type III effects Covariates: Treatment group, Gender, Age Class, Sensitization Status, Asthma Status, Pooled Center, Baseline Average RTSS.|ANCOVA|||||||<0.0001
71000586|NCT04362813|141507397|SUPERIORITY||Odds Ratio (OR)|1.39||||0.2874|TWO_SIDED|95.0|0.76|2.54|||Regression, Logistic|||Odds ratio is based on a Logistic regression model adjusted by treatment, region (North America vs Europe), and baseline 9-point ordinal scale (\<=4, \>=5).||2.54|0.76|0.2874
71000587|NCT04362813|141507398|SUPERIORITY||Odds Ratio (OR)|0.67||||0.3303|TWO_SIDED|95.0|0.3|1.5|||Regression, Logistic|||Odds ratio is based on a Logistic regression model adjusted by treatment, region (North America vs Europe), and baseline 9-point ordinal scale (\<=4, \>=5)||1.50|0.30|0.3303
71000588|NCT00753688|141507452|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35|||<|0.001|TWO_SIDED|95.0|0.26|0.48||Stratified two-sided log rank p-value|Log Rank||The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).|||0.48|0.26|<0.001
71042145|NCT01976728|141593674|SUPERIORITY|||||||0.3173||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 15: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.3173
71000589|NCT00753688|141507453|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.256|TWO_SIDED|95.0|0.67|1.12||Stratified two-sided log rank p-value|Log Rank||The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).|||1.12|0.67|0.256
71000590|NCT00753688|141507457|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.37|||<|0.001|TWO_SIDED|95.0|0.23|0.6||Stratified two-sided log rank p-value for leiomyosarcoma|Log Rank||The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).|||0.60|0.23|<0.001
71042146|NCT01976728|141593674|SUPERIORITY|||||||0.3711||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 18: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.3711
70924046|NCT05229120|141340186|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.498|TWO_SIDED||||||t-test, 1 sided|||Examined changes in parental involvement using a paired-samples t-test.||||.498
70924047|NCT05229120|141340186|SUPERIORITY||Mean Difference (Final Values)|1.301||||0.108|TWO_SIDED||||||t-test, 1 sided|||Examined changes in positive parenting using paired samples t-tests||||.108
70924048|NCT05229120|141340186|SUPERIORITY||Mean Difference (Final Values)|-1.01||||0.145|TWO_SIDED||||||t-test, 1 sided|||Examined changes in parental monitoring using a paired samples t-test||||.145
70924049|NCT05229120|141340186|SUPERIORITY||Mean Difference (Final Values)|-0.688||||0.252|TWO_SIDED||||||t-test, 1 sided|||Examined changes in inconsistent parenting using a paired samples one-sided t-test||||.252
70924050|NCT05229120|141340186|SUPERIORITY||Mean Difference (Final Values)|0.306||||0.382|TWO_SIDED||||||t-test, 1 sided|||Examined changes in corporal punishment using a paired samples one-tailed t-test||||.382
71100582|NCT02732145|141709678|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort due to wearing of tight clothes in symptomatic patients, who wear tight clothes?||||||0.4754|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort due to wearing of tight clothes in symptomatic patients, who wear tight clothes.||||0.4754
71100583|NCT02732145|141709678|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort depending on the menstrual cycle in symptomatic patients of reproductive age?||||||0.1082|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort depending on the menstrual cycle in symptomatic patients of reproductive age.||||0.1082
71100584|NCT02732145|141709678|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort before starting menstrual bleeding in symptomatic patients of reproductive age?||||||0.0179|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort before starting menstrual bleeding in symptomatic patients of reproductive age.||||0.0179
71100585|NCT02732145|141709678|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort during menstrual bleeding in symptomatic patients of reproductive age?||||||0.5722|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort during menstrual bleeding in symptomatic patients of reproductive age.||||0.5722
71100586|NCT02732145|141709678|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort after menstrual bleeding in symptomatic patients of reproductive age?||||||0.6148|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort after menstrual bleeding in symptomatic patients of reproductive age.||||0.6148
71100587|NCT02732145|141709678|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort between two menstrual bleeding in symptomatic patients of reproductive age?||||||0.5307|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort between two menstrual bleeding in symptomatic patients of reproductive age.||||0.5307
71100588|NCT02732145|141709678|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort during urination?||||||0.1546|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort during urination.||||0.1546
71100589|NCT02732145|141709678|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar complaints during urination after sexual intercourse in symptomatic patients, who are sexually active?||||||0.1019|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar complaints during urination after sexual intercourse in symptomatic patients, who are sexually active.||||0.1019
70924051|NCT01566695|141340208|SUPERIORITY||Rate Difference|18.9||||0.0005|TWO_SIDED|95.0|8.3|29.6||2 sided|Stratified Mantel-Haenszel Chi-squared|Stratified by average baseline (BL) RBC tfx needs: ≤4 vs \>4 units of RBC per 28 days; BL platelet tfx status: dependent or ind. \&ECOG PS: 0 to 1 vs 2||||29.6|8.3|0.0005
70924052|NCT01566695|141340212|SUPERIORITY||Rate Difference|21.6|||<|0.0001|TWO_SIDED|95.0|11.9|31.3||2 sided|Stratified Mantel-Haenszel; Chi-squared|Stratified by average baseline (BL) RBC tfx needs: ≤4 vs \>4 units of RBC per 28 days; BL platelet tfx status: dependent or ind. \&ECOG PS: 0 to 1 vs 2||||31.3|11.9|<0.0001
70924053|NCT01566695|141340213|SUPERIORITY|||||||0.4347|||||||Two-Sided Unstratified Log Rank Test|||||||0.4347
70924054|NCT01566695|141340215|SUPERIORITY|HI-E|Rate Difference|10.9||||0.1467|TWO_SIDED|95.0|-2.0|23.7|||Stratified Mantel-Haenszel. Chi-squared|Stratified by average BL RBC tfx needs: ≤4 units versus \>4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2||||23.7|-2.0|0.1467
70924055|NCT01566695|141340215|SUPERIORITY|≥ 1.5 g/dL Hemoglobin Increase|Rate Diffrence|17.9||||0.0002|TWO_SIDED|95.0|8.8|26.9|||Stratified Mantel-Haenszel. Chi-squared|Stratified by average BL RBC tfx needs: ≤4 units versus \>4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2||||26.9|8.8|0.0002
70924056|NCT01566695|141340215|SUPERIORITY|RBC Transfusion Reduction|Rate Difference|10.9||||0.1431|TWO_SIDED|95.0|-1.9|23.6|||Stratified Mantel-Haenszel. Chi-squared|Stratified by average BL RBC tfx needs: ≤4 units versus \>4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2||||23.6|-1.9|0.1431
70924057|NCT01566695|141340216|SUPERIORITY||Rate Difference|17.0||||0.0007|TWO_SIDED|95.0|7.5|26.4|||Stratified Mantel-Haenszel. Chi-squared|Stratified by average BL RBC tfx needs: ≤4 units versus \>4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2||||26.4|7.5|0.0007
70924058|NCT01566695|141340219|OTHER||Hazard Ratio (HR)|1.08||||0.6257|TWO_SIDED|95.0|0.79|1.49|||Log Rank||||Cox proportional hazards model with stratifies factors|1.49|0.79|0.6257
70924059|NCT01566695|141340225|SUPERIORITY|||||||0.214|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.214
70924060|NCT01566695|141340226|SUPERIORITY|||||||0.446|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.446
70924061|NCT01566695|141340227|SUPERIORITY|||||||0.248|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.248
70924062|NCT01566695|141340228|SUPERIORITY|||||||0.058|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.058
71000591|NCT00753688|141507457|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43||||0.005|TWO_SIDED|95.0|0.19|0.98||Stratified two-sided log rank p-value for synovial sarcoma|Log Rank||The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).|||0.98|0.19|0.005
71100590|NCT02732145|141709679|EQUIVALENCE|Question: Is there a difference in the incidence of problems associated with urination and defecation between patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of problems associated with urination and defecation between patients from different groups.||||0.0000
71100591|NCT02732145|141709679|EQUIVALENCE|Question: Is there a difference in the incidence of dysuria between patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of dysuria between patients from different groups.||||0.0000
71100592|NCT02732145|141709679|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent dysuria between patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent dysuria between patients from different groups.||||0.0000
71100593|NCT02732145|141709679|EQUIVALENCE|Question: Is there a difference in the incidence of frequent dysuria between patients from different groups?||||||0.0003|||||||Chi-squared|||Parameter: The difference in the incidence of frequent dysuria between patients from different groups.||||0.0003
71000592|NCT00753688|141507457|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39|||<|0.001|TWO_SIDED|95.0|0.25|0.6||Stratified two-sided log rank p-value for other STS histologies|Log Rank||The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).|||0.60|0.25|<0.001
71000593|NCT01854593|141507463|SUPERIORITY_OR_OTHER|||||||0.025|||||||Wilcoxon (Mann-Whitney)|||||||0.025
71000594|NCT01854593|141507464|SUPERIORITY_OR_OTHER|||||||0.006|||||||Chi-squared|||||||0.006
71100594|NCT02732145|141709679|EQUIVALENCE|Question: Is there a difference in the incidence of urinary incontinence between patients from different groups?||||||0.001|||||||Chi-squared|||Parameter: The difference in the incidence of urinary incontinence between patients from different groups.||||0.0010
71000595|NCT01854593|141507465|SUPERIORITY_OR_OTHER|||||||0.033|||||||Fisher Exact|||||||0.033
71000596|NCT01854593|141507466|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71000597|NCT01854593|141507467|SUPERIORITY_OR_OTHER|||||||0.667|||||||Wilcoxon (Mann-Whitney)|||||||0.667
71000598|NCT01854593|141507468|SUPERIORITY_OR_OTHER|||||||0.593|||||||Fisher Exact|||||||0.593
71100595|NCT02732145|141709679|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent urinary incontinence between patients from different groups?||||||0.1859|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent urinary incontinence between patients from different groups.||||0.1859
71000599|NCT01854593|141507469|SUPERIORITY_OR_OTHER|||||||0.298|||||||Wilcoxon (Mann-Whitney)|||||||0.298
71000600|NCT01854593|141507470|SUPERIORITY_OR_OTHER|||||||0.929|||||||Wilcoxon (Mann-Whitney)|||||||0.929
71000601|NCT01854593|141507471|SUPERIORITY_OR_OTHER|||||||0.445|||||||Wilcoxon (Mann-Whitney)|||||||0.445
71100596|NCT02732145|141709679|EQUIVALENCE|Question: Is there a difference in the incidence of frequent urinary incontinence between patients from different groups?||||||0.0003|||||||Chi-squared|||Parameter: The difference in the incidence of frequent urinary incontinence between patients from different groups.||||0.0003
71000602|NCT01854593|141507472|SUPERIORITY_OR_OTHER|||||||0.131|||||||Chi-squared|||||||0.131
71000603|NCT01854593|141507473|SUPERIORITY_OR_OTHER|||||||0.149|||||||Fisher Exact|||||||0.149
71000604|NCT01854593|141507474|SUPERIORITY_OR_OTHER|||||||0.67|||||||Fisher Exact|||||||0.670
71000605|NCT01854593|141507475|SUPERIORITY_OR_OTHER|||||||0.378|||||||Chi-squared|||||||0.378
71000606|NCT00293241|141507521|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.927||||0.72|TWO_SIDED|95.0|0.612|1.405|||Log Rank||"Hospitalization:hospital admission with overnight stay;ER/office visits with cardioversions;acute treatment of worsened cardiac condition~CV:new/worsening HF,angina,MI,arrhythmia,stroke, TIA,acute peripheral vascular emergencies,pulmonary embolism"|"Analysis:Time to first cardiovascular hospitalization (CV hosp)~H0:freedom from CV hosp MVP=freedom from CV hosp DDD (dual chamber conventional pacing)~Ha:freedom from CV hosp MVP≠freedom from CV hosp DDD~Power calculation:~The study is designed to detect a difference event-free survival after 2 years of 5.5 % absolute, going from 91.5% to 97%.~Test=two-sided alpha=0.05 power=80% 1:1 randomization n=600"||1.405|0.612|0.72
71000607|NCT00293241|141507522|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.127||||0.48|TWO_SIDED|95.0|0.808|1.57|||Log Rank|||"Analysis:Time to first all cause death or cardiovascular hospitalization~H0:freedom from death or CV hospitalization=freedom from death or CV hospitalization~Ha:freedom from death or CV hospitalization≠freedom from death or CV hospitalization"||1.570|0.808|0.48
71000608|NCT00293241|141507523|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.521||||0.08|TWO_SIDED|95.0|0.954|2.424|||Log Rank|||Analysis:Time to first persistent AT/AF H0:freedom from persistent AT/AF=freedom from persistent AT/AF Ha:freedom from persistent AT/AF≠freedom from persistent AT/AF||2.424|0.954|0.08
71100597|NCT02732145|141709679|EQUIVALENCE|Question: Is there a difference in the incidence of difficulties at starting urination between patients from different groups?||||||0.0015|||||||Chi-squared|||Parameter: The difference in the incidence of difficulties at starting urination between patients from different groups.||||0.0015
71000609|NCT00293241|141507524|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.425||||0.44|TWO_SIDED|95.0|0.573|3.543|||Log Rank|||Analysis:Time to permanent AF H0:freedom from permanent AF=freedom from permanent AF Ha:freedom from permanent AF≠freedom from permanent AF||3.543|0.573|0.44
71000610|NCT00293241|141507525|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||"Analysis:Wilcoxon Test for Comparison of Percentage of Ventricular Pacing (%VP) During Followup by Randomization Arm~H0:distribution %VP MVP=distribution %VP DDD~Ha:distribution %VP MVP≠distribution %VP DDD~Ha:"||||<0.0001
71000611|NCT00293241|141507526|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||Regression, Linear|||||||0.048
71000612|NCT00293241|141507528|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED|95.0|||||Repeated measures logistic regression|||Analysis:Repeated measures logistic regression||||0.78
71000613|NCT00293241|141507529|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Regression, Logistic|||Analysis:Repeated measures logistic regression H0:Change in Beta-blockers=Change in Beta-blockers Ha:Change in Beta-blockers≠Change in Beta-blockers||||0.34
71000614|NCT00293241|141507529|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||Regression, Logistic|||Analysis:Repeated measures logistic regression H0:Change in Digitalis/digoxin=Change in Digitalis/digoxin Ha:Change in Digitalis/digoxin≠Change in Digitalis/digoxin||||0.65
71000615|NCT00293241|141507529|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||Regression, Logistic|||Analysis:Repeated measures logistic regression H0:Change in Calcium antagonists=Change in Calcium antagonists Ha:Change in Calcium antagonists≠Change in Calcium antagonists||||0.55
71000616|NCT00293241|141507529|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||Regression, Logistic|||Analysis:Repeated measures logistic regression H0:Change in Antiarrhythmic drug=Change in Antiarrhythmic drug Ha:Change in Antiarrhythmic drug≠Change in Antiarrhythmic drug||||0.53
71000617|NCT00293241|141507531|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.243||||0.33|TWO_SIDED|95.0|0.803|1.923|||Log Rank|||"Analysis:Time to all-cause death~H0:survival MVP ON=survival MVP OFF Ha:survival MVP ON≠survival MVP OFF"||1.923|0.803|0.33
71000618|NCT00293241|141507532|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.492||||0.24|TWO_SIDED|95.0|0.148|1.637|||Log Rank|||||1.637|0.148|0.24
71000619|NCT00293241|141507533|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Statistical test for Number of subjects with CV hospitalization||||0.83
71000620|NCT00293241|141507536|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0:Change in P-R interval=Change in P-R interval Ha:Change in P-R interval≠Change in P-R interval||||0.34
71000621|NCT00293241|141507536|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0:Change in QRS duration=Change in QRS duration Ha:Change in QRS duration≠Change in QRS duration||||0.19
71000622|NCT00293241|141507536|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0:Change in P-wave duration=Change in P-wave duration Ha:Change in P-wave duration≠Change in P-wave duration||||0.29
71000623|NCT00293241|141507537|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED|95.0|||||Fisher Exact|||No Symptoms (Baseline)||||0.24
71000624|NCT00293241|141507537|SUPERIORITY_OR_OTHER|||||||0.92|TWO_SIDED||||||Fisher Exact|||No Symptoms (12 months)||||0.92
71000625|NCT00293241|141507537|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||No Symptoms (24 Months)||||1.0
71000626|NCT00293241|141507538|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
71000627|NCT01216397|141507551|SUPERIORITY_OR_OTHER||adjusted gMean ratio|99.4||||||90.0|94.2|105.0|||ANOVA|||Standard batch vs. Side batch||105.0|94.2|
71000628|NCT01216397|141507552|SUPERIORITY_OR_OTHER||adjusted gMean ratio|100.1||||||90.0|96.1|104.2|||ANOVA|||Standard batch vs. Side batch||104.2|96.1|
71000629|NCT01216397|141507553|SUPERIORITY_OR_OTHER||adjusted gMean ratio|100.1||||||90.0|94.7|105.8|||ANOVA|||Standard batch vs. Side batch||105.8|94.7|
71000630|NCT01216397|141507561|SUPERIORITY_OR_OTHER||adjusted gMean ratio|97.9||||||90.0|92.5|103.7|||ANOVA|||Standard batch vs. Side batch||103.7|92.5|
71000631|NCT01216397|141507562|SUPERIORITY_OR_OTHER||adjusted gMean ratio|100.4||||||90.0|95.7|105.4|||ANOVA|||||105.4|95.7|
71000632|NCT01216397|141507563|SUPERIORITY_OR_OTHER||adjusted gMean ratio|100.3||||||90.0|95.7|105.2|||ANOVA|||Standard batch vs. Side batch||105.2|95.7|
71000633|NCT00971633|141507583|NON_INFERIORITY_OR_EQUIVALENCE|Study Secondary Hypothesis: A single dose of U.K. ZOFRAN (ondansetron) 8-mg table over-encapsulated is bioequivalent to a single dose of the U.K. ZOFRAN (ondansetron) 8-mg tablet. That is, the true geometric mean ratios (U.K. ZOFRAN tablet over-encapsulated/U.K. ZOFRAN tablet) of the area under the plasma concentration vs. time curve (AUC) from zero to infinity and maximum plasma concentration (Cmax) for ondansetron each lie within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.904|||||TWO_SIDED|95.0|0.796|1.028|||||Geometric Mean Ratio (Treatment OE U.K. tablet / Treatment U.K. tablet)|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally||1.028|0.796|
71000634|NCT00971633|141507583|NON_INFERIORITY_OR_EQUIVALENCE|Study Primary Hypothesis: A single dose of the U.K. ZOFRAN (ondansetron) 8-mg tablet over-encapsulated is bioequivalent to a single dose of the U.S. ZOFRAN (ondansetron) 8-mg tablet. That is, the true geometric mean rations (U.K. ZOFRAN tablet over-encapsulated/U.S. ZOFRAN tablet) of the area under the plasma concentration vs. time curve (AUC) from zero to infinity and maximum plasma concentration (Cmax) for ondansetron each lie within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.991|||||TWO_SIDED|95.0|0.873|1.126|||||Geometric Mean Ratio (Treatment OE U.K. tablet / Treatment U.S. tablet)|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United States (U.S.) taken orally||1.126|0.873|
70924063|NCT01566695|141340229|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.130
70924064|NCT01566695|141340230|SUPERIORITY|||||||0.123|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.123
70924065|NCT01566695|141340231|SUPERIORITY|||||||0.069|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.069
70924066|NCT01566695|141340232|SUPERIORITY|||||||0.078|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.078
70924067|NCT01566695|141340233|SUPERIORITY|||||||0.073|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.073
71000635|NCT00971633|141507584|NON_INFERIORITY_OR_EQUIVALENCE|Study Secondary Hypothesis: A single dose of U.K. ZOFRAN (ondansetron) 8-mg table over-encapsulated is bioequivalent to a single dose of the U.K. ZOFRAN (ondansetron) 8-mg tablet. That is, the true geometric mean ratios (U.K.) ZOFRAN tablet over-encapsulated/U.K. ZOFRAN tablet) of the area under the plasma concentration vs. time curve (AUC) from zero to infinity and maximum plasma concentration (Cmax) for ondansetron each lie within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.886|||||TWO_SIDED|95.0|0.813|0.966|||||Geometric Mean Ratio (Treatment OE U.K. tablet / Treatment U.K. tablet)|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally||0.966|0.813|
71000636|NCT00971633|141507584|NON_INFERIORITY_OR_EQUIVALENCE|§ Study Primary Hypothesis: A single dose of the U.K. ZOFRAN (ondansetron) 8-mg tablet over-encapsulated is bioequivalent to a single dose of the U.S. ZOFRAN (ondansetron) 8-mg tablet. That is, the true geometric mean rations (U.K. ZOFRAN tablet over-encapsulated/U.S. ZOFRAN tablet) of the area under the plasma concentration vs. time curve (AUC) from zero to infinity and maximum plasma concentration (Cmax) for ondansetron each lie within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.951|||||TWO_SIDED|95.0|0.872|1.037|||||Geometric Mean Ratio (Treatment OE U.K. tablet / Treatment U.S. tablet)|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally. Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United States (U.S.) taken orally||1.037|0.872|
71000637|NCT01455415|141507586|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.2||||0.3287|TWO_SIDED|95.0|0.83|1.73||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Regression, Logistic|||Analysis was done using a logistic regression model which included baseline pain, sequence, period and treatment as covariate.||1.73|0.83|0.3287
71000638|NCT01455415|141507587|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.57||||0.0625|TWO_SIDED|95.0|0.98|2.51||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Regression, Logistic|||Analysis was done using a logistic regression model which included baseline pain, sequence, period and treatment as covariate.||2.51|0.98|0.0625
71100598|NCT02732145|141709679|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent difficulties at starting urination between patients from different groups?||||||0.0013|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent difficulties at starting urination between patients from different groups.||||0.0013
71100599|NCT02732145|141709679|EQUIVALENCE|Question: Is there a difference in the incidence of frequent difficulties at starting urination between patients from different groups?||||||0.5673|||||||Chi-squared|||Parameter: The difference in the incidence of frequent difficulties at starting urination between patients from different groups.||||0.5673
70924068|NCT01566695|141340234|SUPERIORITY||Common Odds Raatio|0.77||||0.56|TWO_SIDED|95.0|0.54|1.3|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|1.30|0.54|0.560
70924069|NCT01566695|141340235|SUPERIORITY||Common Odds Raatio|0.72||||0.48|TWO_SIDED|95.0|0.29|1.78|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|1.78|0.29|0.480
70924070|NCT01566695|141340236|SUPERIORITY||Common Odds Ratio|1.67||||0.197|TWO_SIDED|95.0|0.76|3.65|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|3.65|0.76|0.197
70924071|NCT01566695|141340237|SUPERIORITY||Common Odds Ratio|2.14||||0.121|TWO_SIDED|95.0|0.82|5.57|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|5.57|0.82|0.121
70924072|NCT01566695|141340238|SUPERIORITY||Common Odds Ratio|2.0||||0.075|TWO_SIDED|95.0|0.93|4.3|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|4.30|0.93|0.075
70924073|NCT01566695|141340239|SUPERIORITY||Common Odds Ratio|1.58||||0.222|TWO_SIDED|95.0|0.76|3.29|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|3.29|0.76|0.222
71000639|NCT01455415|141507588|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.11||0.9448|TWO_SIDED|95.0|-0.21|0.22||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline pain severity, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.22|-0.21|0.9448
71000640|NCT01455415|141507589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.12||0.4548|TWO_SIDED|95.0|-0.32|0.14||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline interference score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.14|-0.32|0.4548
71000641|NCT01455415|141507590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.11||0.0272|TWO_SIDED|95.0|-0.44|-0.03||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using linear mixed effects model including baseline score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||-0.03|-0.44|0.0272
71000642|NCT01455415|141507591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.18||0.7344|TWO_SIDED|95.0|-0.42|0.3||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline HADS-A score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.30|-0.42|0.7344
71000643|NCT01455415|141507592|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.17||0.6007|TWO_SIDED|95.0|-0.42|0.24||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline HADS-D score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.24|-0.42|0.6007
71000644|NCT01455415|141507593|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|1.04||0.2987|TWO_SIDED|95.0|-3.13|0.96||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline total score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.96|-3.13|0.2987
71000645|NCT01455415|141507594|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.26||0.1769|TWO_SIDED|95.0|-0.85|0.16||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline symptoms domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.16|-0.85|0.1769
71000646|NCT01455415|141507595|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.18||0.5119|TWO_SIDED|95.0|-0.48|0.24||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline activities of daily living domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.24|-0.48|0.5119
71042147|NCT01976728|141593674|SUPERIORITY|||||||0.4142||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 18: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.4142
71042148|NCT01976728|141593674|SUPERIORITY|||||||0.0838||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 18: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.0838
71042149|NCT01976728|141593674|SUPERIORITY|||||||0.3173||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 21: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.3173
71042150|NCT01976728|141593674|SUPERIORITY|||||||0.3778||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 21: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.3778
71042151|NCT01976728|141593675|SUPERIORITY||Least square mean (LSM) difference|1.35||||0.6732|TWO_SIDED|95.0|-5.16|7.87||p-value for the LutrePulse 10 µg group compared to placebo based on the fitted linear model were reported.|ANCOVA|PROC GLM was used for ANCOVA.|The LSM difference on the treatment groups and 95% confidence interval (CI) for the LutrePulse 10 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.|Maximum P4 levels in the LutrePulse 10 µg group were compared to placebo using an analysis of covariance (ANCOVA) model including the randomization scheme and treatment group as factors and baseline value as covariate.||7.87|-5.16|0.6732
71000647|NCT01455415|141507596|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.62||0.4335|TWO_SIDED|95.0|-1.72|0.74||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline physical functioning / large fiber domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.74|-1.72|0.4335
71000648|NCT01455415|141507597|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.16||0.9653|TWO_SIDED|95.0|-0.31|0.3||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline small fiber domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.30|-0.31|0.9653
71000649|NCT01455415|141507598|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.12||0.269|TWO_SIDED|95.0|-0.38|0.11||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline autonomic domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.11|-0.38|0.2690
71000650|NCT01455415|141507599|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.9951|TWO_SIDED|95.0|-0.05|0.05||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline mobility domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.05|-0.05|0.9951
71000651|NCT01455415|141507600|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.9726|TWO_SIDED|95.0|-0.05|0.05||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline self-care domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.05|-0.05|0.9726
71000652|NCT01455415|141507601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.03||0.5497|TWO_SIDED|95.0|-0.04|0.08||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline usual activities domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.08|-0.04|0.5497
71000653|NCT01455415|141507602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.1495|TWO_SIDED|95.0|-0.02|0.11||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline pain / discomfort domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.11|-0.02|0.1495
71000654|NCT01455415|141507603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.03||0.1297|TWO_SIDED|95.0|-0.11|0.01||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline anxiety / depression domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.01|-0.11|0.1297
71000655|NCT01455415|141507604|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.4279|TWO_SIDED|95.0|-0.04|0.02||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline Dolan 1997 index summary score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.02|-0.04|0.4279
71100600|NCT02732145|141709679|EQUIVALENCE|Question: Is there a difference in the incidence of urgency between patients from different groups?||||||0.0065|||||||Chi-squared|||Parameter: The difference in the incidence of urgency between patients from different groups.||||0.0065
71100601|NCT02732145|141709679|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent urgency between patients from different groups?||||||0.083|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent urgency between patients from different groups.||||0.0830
71100602|NCT02732145|141709679|EQUIVALENCE|Question: Is there a difference in the incidence of frequent urgency between patients from different groups?||||||0.0001|||||||Chi-squared|||Parameter: The difference in the incidence of frequent urgency between patients from different groups.||||0.0001
71100603|NCT02732145|141709679|EQUIVALENCE|Question: Is there a difference in the incidence of nocturia between patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of nocturia between patients from different groups.||||0.0000
71100604|NCT02732145|141709679|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent nocturia between patients from different groups?||||||0.2315|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent nocturia between patients from different groups.||||0.2315
71042152|NCT01976728|141593675|SUPERIORITY||LSM|5.7||||0.0814|TWO_SIDED|95.0|-0.76|12.15||p-value for the LutrePulse 15 µg group compared to placebo based on the fitted linear model were reported.|ANCOVA|PROC GLM was used for ANCOVA.|The LSM difference on the treatment groups and 95% CI for the LutrePulse 15 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.|Maximum P4 levels in the LutrePulse 15 µg group were compared to placebo using an ANCOVA model including treatment group as factors and baseline value as covariate.||12.15|-0.76|0.0814
71100605|NCT02732145|141709679|EQUIVALENCE|Question: Is there a difference in the incidence of frequent nocturia between patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of frequent nocturia between patients from different groups.||||0.0000
71100606|NCT02732145|141709679|EQUIVALENCE|Question: Is there a difference in the incidence of recurrent cystitis between patients from different groups?||||||0.0539|||||||Chi-squared|||Parameter: The difference in the incidence of recurrent cystitis between patients from different groups.||||0.0539
71000656|NCT01455415|141507605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.5505|TWO_SIDED|95.0|-0.04|0.02||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline Dolan 2001 index summary score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.02|-0.04|0.5505
71042153|NCT01976728|141593675|SUPERIORITY||LSM difference|7.55||||0.0223|TWO_SIDED|95.0|1.16|13.93||p-value for the LutrePulse 20 µg group compared to placebo based on the fitted linear model were reported.|ANCOVA|PROC GLM was used for ANCOVA.|The LSM difference on the treatment groups and 95% CI for the LutrePulse 20 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.|Maximum P4 levels in the LutrePulse 20 µg group were compared to placebo using an ANCOVA model including the randomization scheme and treatment group as factors and baseline value as covariate.||13.93|1.16|0.0223
71042154|NCT01976728|141593676|SUPERIORITY||LSM difference|0.679||||0.7355|TWO_SIDED|95.0|-3.404|4.762||p-value for the LutrePulse 10 µg group compared to placebo based on the fitted linear model were reported.|ANCOVA|PROC GLM was used for ANCOVA.|The LSM difference on the treatment groups and 95% CI for the LutrePulse 10 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.|Mean P4 levels in the LutrePulse 10 µg group were compared to placebo using an ANCOVA model including the randomization scheme and treatment group as factors and baseline value as covariate.||4.762|-3.404|0.7355
71042155|NCT01976728|141593676|SUPERIORITY||LSM difference|2.602||||0.198|TWO_SIDED|95.0|-1.444|6.648||p-value for the LutrePulse 15 µg group compared to placebo based on the fitted linear model were reported.|ANCOVA|PROC GLM was used for ANCOVA.|The LSM difference on the treatment groups and 95% CI for the LutrePulse 15 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.|Mean P4 levels in the LutrePulse 15 µg group were compared to placebo using an ANCOVA model including treatment group as factors and baseline value as covariate.||6.648|-1.444|0.1980
71042156|NCT01976728|141593676|SUPERIORITY||LSM difference|4.88||||0.0187|TWO_SIDED|95.0|0.878|8.882||p-value for the LutrePulse 10 µg group compared to placebo based on the fitted linear model were reported.|ANCOVA|PROC GLM was used for ANCOVA.|The LSM difference on the treatment groups and 95% CI for the LutrePulse 20 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.|Mean P4 levels in the LutrePulse 20 µg group were compared to placebo using an ANCOVA model including the randomization scheme and treatment group as factors and baseline value as covariate.||8.882|0.878|0.0187
71042157|NCT01976728|141593677|SUPERIORITY||LSM difference|0.03||||0.8772|TWO_SIDED|95.0|-0.39|0.46||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in FSH levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 10 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||0.46|-0.39|0.8772
71042158|NCT01976728|141593677|SUPERIORITY||LSM difference|0.07||||0.7805|TWO_SIDED|95.0|-0.44|0.58||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in FSH levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 15 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||0.58|-0.44|0.7805
71100607|NCT02732145|141709679|EQUIVALENCE|Question: Is there a difference in the incidence of constipation between patients from different groups?||||||0.0379|||||||Chi-squared|||Parameter: The difference in the incidence of constipation between patients from different groups.||||0.0379
71000657|NCT01455415|141507606|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0604|TWO_SIDED|||||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Cochran-Mantel-Haenszel|||Analysis was done using a Cochran-Mantel-Haenszel (CMH) test with modified ridit transformation, under alternative hypothesis of raw mean scores differ.||||0.0604
71000658|NCT01455415|141507607|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.038|STANDARD_ERROR_OF_MEAN|0.106||0.7174|TWO_SIDED|95.0|-0.248|0.171||Primary analysis was two-sided and performed at the 0.05 significance level.|Repeated measure mixed effects model|The Kenward-Roger method was used to estimate denominator degrees of freedom.||A longitudinal analysis was done using a repeated measure linear mixed effects model including visit, treatment, an indicator variable for Week 6, and treatment by visit and by the indicator variable interaction as fixed effect factors and participant within sequence and within-participant error (estimated by using an unstructured covariance structure) as random factors. The treatment differences were tested using within-participant variability as the error term.||0.171|-0.248|0.7174
71000659|NCT01455415|141507608|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1511|TWO_SIDED|||||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Cochran-Mantel-Haenszel|||Analysis was done using a CMH test with modified ridit transformation, under alternative hypothesis of raw mean scores differ.||||0.1511
71000660|NCT01496274|141507622|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P value is based on a Wilcoxon signed-rank test of H0: AsBR ratio (prophylaxis regimen/on-demand regimen) ≥ 0.50. The ratio was based on the original scale.|Wilcoxon signed-rank test|||A test of null hypothesis that the ratio of AsBR (prophylaxis regimen/on-demand regimen) was ≥ 0.50 was conducted at the 1-sided 0.025 level. Matched pairs design with 19 subjects and 2 observations per subject.||||<0.0001
71000661|NCT01459068|141507688|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|We estimated 150 participants in each arm using the test for paired means, based on a moderate effect size (0.50), 80% power, two-tailed 5% significance level, design effect of 1.5, and up to a 50% expected drop-out rate (due to frequent cross-border movement).|Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.59|-0.4||a priori threshold for statistical significance was 0.05.|longitudinal model|longitudinal to model within-person change in mean scores||||-0.40|-0.59|<0.001
71042159|NCT01976728|141593677|SUPERIORITY||LSM difference|0.12||||0.6095|TWO_SIDED|95.0|-0.35|0.58||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in FSH levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 20 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||0.58|-0.35|0.6095
71042160|NCT01976728|141593678|SUPERIORITY||LSM difference|0.51||||0.152|TWO_SIDED|95.0|-0.2|1.22||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in LH levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 10 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||1.22|-0.20|0.1520
71042161|NCT01976728|141593678|SUPERIORITY||LSM difference|0.93||||0.0221|TWO_SIDED|95.0|0.14|1.72||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in LH levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 15 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||1.72|0.14|0.0221
71100608|NCT02732145|141709679|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent constipation between patients from different groups?||||||0.1485|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent constipation between patients from different groups.||||0.1485
71100609|NCT02732145|141709679|EQUIVALENCE|Question: Is there a difference in the incidence of frequent constipation between patients from different groups?||||||0.4155|||||||Chi-squared|||Parameter: The difference in the incidence of frequent constipation between patients from different groups.||||0.4155
71100610|NCT02732145|141709679|EQUIVALENCE|Question: Is there a difference in the incidence of diarrhea between patients from different groups?||||||0.0092|||||||Chi-squared|||Parameter: The difference in the incidence of diarrhea between patients from different groups.||||0.0092
71100611|NCT02732145|141709679|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent diarrhea between patients from different groups?||||||0.0192|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent diarrhea between patients from different groups.||||0.0192
71100612|NCT02732145|141709679|EQUIVALENCE|Question: Is there a difference in the incidence of frequent diarrhea between patients from different groups?||||||0.5253|||||||Chi-squared|||Parameter: The difference in the incidence of frequent diarrhea between patients from different groups.||||0.5253
71100613|NCT02732145|141709679|EQUIVALENCE|Question: Is there a difference in the incidence of the irritable colon between patients from different groups?||||||0.006|||||||Chi-squared|||Parameter: The difference in the incidence of the irritable colon between patients from different groups.||||0.0060
71100614|NCT02732145|141709680|EQUIVALENCE|Question: Is there a difference in the incidence of any associated symptom or disease among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of any associated symptom or disease among patients from different groups.||||0.0000
71100615|NCT02732145|141709680|EQUIVALENCE|Question: Is there a difference in the incidence of a frequent headache among patients from different groups?||||||0.3957|||||||Chi-squared|||Parameter: The difference in the incidence of a frequent headache among patients from different groups.||||0.3957
71100616|NCT02732145|141709680|EQUIVALENCE|Question: Is there a difference in the incidence of chronic fatigue among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of chronic fatigue among patients from different groups.||||0.0000
71000662|NCT01459068|141507689|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|power calculations were not done for secondary outcomes|Mean Difference (Net)|-0.44|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.59|-0.28|||longitudinal model|||||-0.28|-0.59|<0.001
71000663|NCT01459068|141507690|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|We estimated 150 participants in each arm using the test for paired means, based on a moderate effect size (0.50), 80% power, two-tailed 5% significance level, design effect of 1.5, and up to a 50% expected drop-out rate (due to frequent cross-border movement).|Mean Difference (Net)|-0.43|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|95.0|-0.51|-0.35||a priori threshold for significance set at 0.05|longitudinal model|longitudinal analysis modeling within-person change in mean scores||||-0.35|-0.51|<0.001
71000664|NCT01459068|141507691|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|no power calculations on secondary outcomes|Mean Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.61|-0.34|||longitudinal model|||||-0.34|-0.61|<0.001
71000665|NCT01459068|141507692|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|no power calculations for secondary measures|Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.34|-0.15|||longitudinal model|||||-0.15|-0.34|<0.001
71000666|NCT01459068|141507693|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|no power calculations for secondary measures|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.26||0.896|TWO_SIDED|95.0|-0.44|0.5|||longitudinal model|||||0.50|-0.44|0.896
71000667|NCT00701441|141507709|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||For comparing pre versus post, paired t tests were used. We considered tests in the hypothesized direction conclusive|t-test, 2 sided|For each comparison, we tested at the 0.05 level with double-sided P values. We used no correction for multiple testing when declaring significance.||Flow mediated dilation = \[(average maximum dilation post cuff deflation - average baseline diameter)/ average baseline diameter\]100||||0.02
71000668|NCT00701441|141507710|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||We only consider tests in the hypothesized direction conclusive, so testing is conservative from that perspective. However, we used no correction for multiple testing when declaring significance|t-test, 2 sided|||For comparing pre- versus post-treatment, paired t tests were used. For each variable and comparison, we tested at the 0.05 level with double-sided P values.||||0.02
71000669|NCT01015820|141507711|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Statistical significance p ≤ 0.05||||0.001
71000670|NCT01015820|141507712|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Statistical significance p ≤ 0.05||||0.03
71000671|NCT02690168|141507720|OTHER|||||||0.0053|||||||t-test, 2 sided|||||||0.0053
71000672|NCT02690168|141507721|OTHER|||||||0.477|||||||t-test, 2 sided|||||||0.477
71000673|NCT02690168|141507722|OTHER|||||||0.917|||||||t-test, 2 sided|||||||0.917
71000674|NCT02690168|141507724|OTHER|||||||0.53|||||||t-test, 2 sided|||||||0.53
71000675|NCT01961089|141507727|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test.||||||0.09|||||||Paired t-test|||P-value comparing AL between G6 and IOLM||||0.09
71000676|NCT01961089|141507727|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.001|||||||Paired t-test|||P-value comparing AL between G6 and LS||||<0.001
71000677|NCT01961089|141507727|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.0001|||||||Paired t-test|||P-value comparing AL between IOLM and LS||||<0.0001
71000678|NCT01961089|141507727|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.0001|||||||Paired t-test|||P-value comparing CCT between G6 and LS||||<0.0001
71000679|NCT01961089|141507727|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.0001|||||||Paired t-test|||P-value comparing ACD between G6 and IOLM||||<0.0001
71000680|NCT01961089|141507727|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.01|||||||Paired t-test|||P-value comparing ACD between G6 and LS||||<0.01
71000681|NCT01961089|141507727|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test||||||0.02|||||||Paired t-test|||P-value comparing ACD between IOLM and LS||||0.02
71000682|NCT01961089|141507727|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.01|||||||Paired t-test|||P-value comparing LT between G6 and LS||||<0.01
71000683|NCT01961089|141507727|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.0001|||||||Paired t-test|||P-value comparing WtW between G6 and IOLM||||<0.0001
71000684|NCT01961089|141507727|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.0001|||||||Paired t-test|||P-value comparing WtW between G6 and LS||||<0.0001
71000685|NCT01961089|141507727|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.001|||||||Paired t-test|||P-value comparing WtW between IOLM and LS||||<0.001
71000686|NCT01961089|141507728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||ANOVA|||Repeatability was determined with random effect ANOVAs (estimates of random effects). They were calculated as the square root of the sum of the (Device x EyeID) interaction component plus (EyeID) and (Device) variance components plus the residual variance component. A (Device x Operator) interaction component was not assessed because each device was consistently operated by the same operator such that there was no Device x Operator interaction component. CV = Coefficient of Variation = SD/mean.||||0.05
71000687|NCT01961089|141507729|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test||||||0.13|||||||Paired t-test|||P-value comparing SimK between G6 and IOLM||||0.13
71000688|NCT01961089|141507729|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test||||||0.25|||||||Paired t-test|||P-value comparing SimK between G6 and LS||||0.25
71000689|NCT01961089|141507729|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test||||||0.21|||||||Paired t-test|||P-value comparing SimK between IOLM and LS||||0.21
70924074|NCT01566695|141340240|SUPERIORITY||Common Odds Ratio|1.65||||0.249|TWO_SIDED|95.0|0.71|3.83|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|3.83|0.71|0.249
70924075|NCT01566695|141340241|SUPERIORITY||Common Odds Ratio|2.03||||0.082|TWO_SIDED|95.0|0.92|4.48|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|4.48|0.92|0.082
71000690|NCT04209400|141507732|NON_INFERIORITY|P \< 0.05 is considered a statistically significant difference in seroconversion between the two groups.||||||1|||||||Chi-squared|||The null hypothesis is that the vaccines equally affect the achievement of seroconversion level.||||1
71000691|NCT01203787|141507752|SUPERIORITY_OR_OTHER|||||||0.0262|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.0262
71000692|NCT01685203|141507794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.381|TWO_SIDED||||||Regression, Logistic|Treatment group, baseline log(subscript)10(subscript) HCV RNA level and Interleukin-28B (IL28B) genotype (CC or non-CC) were used as predictors||||||0.381
71000693|NCT01685203|141507794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.086|TWO_SIDED|||||Difference in rates after adjusting for Interleukin-28 (IL28) genotype (CC or Non-CC) using stratum-adjusted Mantel-Haenszel proportions and continuity-corrected variances.|Stratum-adjusted Mantel-Haenszel|||||||0.086
71000694|NCT01576406|141507801|SUPERIORITY||Geometric mean ratio|91.2|||||TWO_SIDED|90.0|57.47|144.72||||||Confidence interval (CI): Geometric mean ratio and 90 percent (%) CI were derived from analysis of variance (ANOVA) model.||144.72|57.47|
71000695|NCT01576406|141507801|SUPERIORITY||Geometric mean ratio|143.82|||||TWO_SIDED|90.0|89.11|232.12||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||232.12|89.11|
71000696|NCT01576406|141507801|SUPERIORITY||Geometric mean ratio|108.87|||||TWO_SIDED|90.0|70.13|168.99||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||168.99|70.13|
71000697|NCT01576406|141507801|SUPERIORITY||Geometric mean ratio|72.63|||||TWO_SIDED|90.0|49.07|107.5||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||107.50|49.07|
71000698|NCT01576406|141507827|SUPERIORITY||Percentage of ratio of geometric mean|91.12|||||TWO_SIDED|90.0|56.56|146.79||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||146.79|56.56|
71000699|NCT01576406|141507827|SUPERIORITY||Percentage of ratio of geometric mean|149.54|||||TWO_SIDED|90.0|91.85|243.46||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||243.46|91.85|
71000700|NCT01576406|141507827|SUPERIORITY||Percentage of ratio of geometric mean|114.08|||||TWO_SIDED|90.0|73.57|176.89||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||176.89|73.57|
71100617|NCT02732145|141709680|EQUIVALENCE|Question: Is there a difference in the incidence of lumbar pain among patients from different groups?||||||0.0001|||||||Chi-squared|||Parameter: The difference in the incidence of lumbar pain among patients from different groups.||||0.0001
71000701|NCT01576406|141507827|SUPERIORITY||Percentage of ratio of geometric mean|64.67|||||TWO_SIDED|90.0|39.5|105.89||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||105.89|39.50|
71000702|NCT01576406|141507828|SUPERIORITY||Percentage of ratio of geometric mean|108.43|||||TWO_SIDED|90.0|63.47|185.26||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||185.26|63.47|
71000703|NCT01576406|141507828|SUPERIORITY||Percentage of ratio of geometric mean|202.89|||||TWO_SIDED|90.0|120.96|340.3||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||340.30|120.96|
71000704|NCT01576406|141507828|SUPERIORITY||Percentage of ratio of geometric mean|130.78|||||TWO_SIDED|90.0|86.61|197.47||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||197.47|86.61|
71000705|NCT01576406|141507828|SUPERIORITY||Percentage of ratio of geometric mean|62.82|||||TWO_SIDED|90.0|42.54|92.78||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||92.78|42.54|
71000706|NCT01962688|141507843|OTHER|||||||0.002|||||||Chi-squared|||||||0.002
71000707|NCT01375647|141507847|SUPERIORITY||Risk Difference (RD)|-2.9||||0.4|TWO_SIDED|95.0|-9.6|3.9|||Chi-squared|2 sided, not adjusted||||3.9|-9.6|0.4
71000708|NCT01375647|141507848|SUPERIORITY||Risk Difference (RD)|13.4||||4e-05|TWO_SIDED|95.0|7.0|19.8||2-sided, no adjustment|Chi-squared|||||19.8|7.0|0.00004
70924076|NCT01566695|141340242|SUPERIORITY||Common Odds Ratio|1.86||||0.153|TWO_SIDED|95.0|0.79|4.34|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|4.34|0.79|0.153
70924077|NCT01566695|141340243|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
70924078|NCT01566695|141340244|SUPERIORITY|||||||0.046|||||||Fisher Exact|||||||0.046
70924079|NCT01566695|141340245|SUPERIORITY|||||||0.134|||||||Fisher Exact|||||||0.134
70924080|NCT01566695|141340246|SUPERIORITY|||||||0.324|||||||Fisher Exact|||||||0.324
71000709|NCT01375647|141507849|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.5|TWO_SIDED||||||t-test, 2 sided|||Sabin type 1 shedding||||0.5
71000710|NCT01375647|141507849|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.2|TWO_SIDED||||||t-test, 2 sided|||Sabin type 2 shedding||||0.2
71000711|NCT01375647|141507849|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.1|TWO_SIDED||||||t-test, 2 sided|||Sabin type 3 shedding||||0.1
71000712|NCT01375647|141507851|SUPERIORITY||Risk Difference (RD)|-1.4|||||TWO_SIDED|95.0|-7.3|4.5||||||Sabin type 1||4.5|-7.3|
71000713|NCT01375647|141507851|SUPERIORITY||Risk Difference (RD)|-3.1|||||TWO_SIDED|95.0|-7.2|0.9||||||Sabin type 2||0.9|-7.2|
71000714|NCT01375647|141507851|SUPERIORITY||Risk Difference (RD)|1.4|||||TWO_SIDED|95.0|-3.2|6.1||||||||6.1|-3.2|
71000715|NCT01375647|141507852|SUPERIORITY||Risk Difference (RD)|-33.7|||||TWO_SIDED|95.0|-40.7|-26.5||||||||-26.5|-40.7|
71000716|NCT01375647|141507852|SUPERIORITY||Risk Difference (RD)|-24.3|||||TWO_SIDED|95.0|-31.1|-17.5||||||||-17.5|-31.1|
71100618|NCT02732145|141709680|EQUIVALENCE|Question: Is there a difference in the incidence of fibromyalgia among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of fibromyalgia among patients from different groups.||||0.0000
70924081|NCT01566695|141340247|SUPERIORITY|||||||0.442|||||||Fisher Exact|||||||0.442
70924082|NCT01566695|141340248|SUPERIORITY|||||||0.063|||||||Fisher Exact|||||||0.063
70924083|NCT01566695|141340249|SUPERIORITY|||||||0.198|||||||Fisher Exact|||||||0.198
71000717|NCT01375647|141507852|SUPERIORITY||Risk Difference (RD)|-45.6|||||TWO_SIDED|95.0|-52.6|-38.0||||||||-38.0|-52.6|
71000718|NCT01375647|141507853|SUPERIORITY|||||||0.981|||||||Wilcoxon (Mann-Whitney)|||||||0.981
71000719|NCT01375647|141507854|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71000720|NCT02971007|141507935|OTHER|Statistical analyses primarily descriptive with no formal statistical hypothesis testing. Summary statistics are presented by treatment group. For continuous variables, the number of observations, mean, standard deviation, median, minimum and maximum are provided as summary statistics.||||||||||||||||No formal sample size calculations were made. The sample size was determined empirically rather than with a specific statistical rationale and is considered sufficient to achieve the study objectives of this proof of concept study. Women with moderate to severe Vulvovaginal candidiasis were randomized in a 1:1:1 ratio to 1 of 3 treatment groups, stratified by signs and symptoms composite score of up to 12 (moderate) and greater than 13 (severe).|Statistical analyses primarily descriptive with no formal statistical hypothesis testing. Summary statistics are presented by treatment group. For continuous variables, the number of observations, mean, standard deviation, median, minimum and maximum are provided as summary statistics.|||
71000721|NCT02707601|141507958|SUPERIORITY|||||||0.002||||||The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 88%.|Binomial test|||||||0.002
71000722|NCT02707601|141507958|SUPERIORITY|||||||0.042||||||The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 88%.|Binomial test|||||||0.042
71042162|NCT01976728|141593678|SUPERIORITY||LSM difference|0.76||||0.0316|TWO_SIDED|95.0|0.07|1.44||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in LH levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 20 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||1.44|0.07|0.0316
71100619|NCT02732145|141709680|EQUIVALENCE|Question: Is there a difference in the incidence of energy loss among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of energy loss among patients from different groups.||||0.0000
70924084|NCT01566695|141340250|SUPERIORITY|||||||0.972|||||||Fisher Exact|||||||0.972
70924085|NCT01566695|141340251|SUPERIORITY|||||||0.601|||||||Fisher Exact|||||||0.601
70924086|NCT01566695|141340252|SUPERIORITY|||||||0.07|||||||Fisher Exact|||||||0.070
70924087|NCT01566695|141340253|SUPERIORITY|||||||0.436|||||||Fisher Exact|||||||0.436
70924088|NCT01566695|141340254|SUPERIORITY|||||||0.683|||||||Fisher Exact|||||||0.683
70924089|NCT05956002|141340292|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUClast for etrasimod 2 mg mini tablets mixed with applesauce (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|94.66|||||TWO_SIDED|90.0|91.33|98.12|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2mg mini tablets in applesauce vs etrasimod 2mg clinical IR tablet mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||98.12|91.33|
70924090|NCT05956002|141340292|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUClast for etrasimod 2 mg mini tablets mixed with chocolate pudding (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|94.96|||||TWO_SIDED|90.0|91.69|98.34|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in chocolate pudding vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||98.34|91.69|
71000723|NCT02707601|141507959|SUPERIORITY|||||||0.002||||||The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 88%.|Binomial test|||||||0.002
71000724|NCT02707601|141507959|SUPERIORITY|||||||0.002||||||The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 88%.|Binomial test|||||||0.002
71000725|NCT02707601|141507960|OTHER||Difference in Percentages|0.0||||1|TWO_SIDED|95.0|-6.1|6.1|||Fisher exact test||The differences in percentages of participants between treatment groups and their 95% confidence intervals (CIs) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|||6.1|-6.1|1.00
71000726|NCT02009930|141507962|OTHER||Wilson Method used|16.0|||||TWO_SIDED|95.0|9.4|22.9||||||||22.9|9.4|
71000727|NCT02009930|141507963|OTHER||||||||||||||||||Only descriptive statistics were calculated (frequency, percent). Inferential statistics were not necessary, nor appropriate|||
71000728|NCT02009930|141507964|OTHER|||||||0.79||||||Correlation between FRS and CAC risk categories in participants with at least 1 additional risk factor expressed as a p-value|Spearman's Rank Correlation Coefficient|Correlation between FRS and CAC risk categories in participants with at least 1 additional risk factor. Spearman's rho = 0.04||Compare risk categories (FRS and CAC)||||0.79
71000729|NCT02009930|141507965|OTHER|||||||0.063||||||Relationship between FRS and metabolic syndrome. FRS risk category (low, mod, mod-high, high, very high risk) and metabolic syndrome (presence/absence of metabolic syndrome)|Fisher Exact|Relationship between 2 variables (FRS - each risk category, metabolic syndrome - presence/absence) expressed as a p-value||FRS risk category (low, mod, mod-high, high, very high risk)||||0.063
71000730|NCT02009930|141507965|OTHER|||||||0.21||||||Relationship between CAC and metabolic syndrome. CAC risk category (low, low-mod, mod-high, high, very high risk) and metabolic syndrome (presence/absence of metabolic syndrome)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, metabolic syndrome - presence/absence) expressed as a p-value||CAC risk category (low, low-mod, mod-high, high, very high)||||0.21
71000731|NCT02009930|141507966|OTHER|||||||0.56||||||Relationship between FRS and living in the dorms. FRS risk category (low, mod, mod-high, high, very high risk) and living in the dorms (\< 5 years, \> 5 years)|Fisher Exact|Relationship between 2 variables (FRS - each risk category, living in the dorms - \<5 years/\> 5 years) expressed as a p-value||FRS risk categories (low, moderate, mod -high, high, and very high)||||0.56
71100620|NCT02732145|141709680|EQUIVALENCE|Question: Is there a difference in the incidence of sleep disorders among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of sleep disorders among patients from different groups.||||0.0000
71100621|NCT02732145|141709680|EQUIVALENCE|Question: Is there a difference in the incidence of pelvic pain among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of pelvic pain among patients from different groups.||||0.0000
71100622|NCT02732145|141709680|EQUIVALENCE|Question: Is there a difference in the incidence of unintended weight loss among patients from different groups?||||||0.1764|||||||Chi-squared|||Parameter: The difference in the incidence of unintended weight loss among patients from different groups.||||0.1764
71100623|NCT02732145|141709680|EQUIVALENCE|Question: Is there a difference in the incidence of endometriosis among patients from different groups?||||||0.3127|||||||Chi-squared|||Parameter: The difference in the incidence of endometriosis among patients from different groups.||||0.3127
71100624|NCT02732145|141709680|EQUIVALENCE|"Question: Is there a difference in the incidence of D-D-D Triad among patients from different groups?"||||||0.0028|||||||Chi-squared|||"Parameter: The difference in the difference in the incidence of D-D-D Triad (Dysmenorrhoea-Dyspareunia-Dysuria) among patients from different groups."||||0.0028
71100625|NCT02732145|141709680|EQUIVALENCE|Question: Is there a difference in the incidence of hypertension among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of hypertension among patients from different groups.||||0.0000
71100626|NCT02732145|141709680|EQUIVALENCE|Question: Is there a difference in the incidence of genital herpes among patients from different groups?||||||0.9323|||||||Chi-squared|||Parameter: The difference in the incidence of genital herpes among patients from different groups.||||0.9323
71100627|NCT02732145|141709680|EQUIVALENCE|Question: Is there a difference in the incidence of thyroid disease among patients from different groups?||||||0.0011|||||||Chi-squared|||Parameter: The difference in the incidence of thyroid disease among patients from different groups.||||0.0011
71100628|NCT02732145|141709680|EQUIVALENCE|Question: Is there a difference in the incidence of drug allergy among patients from different groups?||||||0.2756|||||||Chi-squared|||Parameter: The difference in the incidence of drug allergy among patients from different groups.||||0.2756
71100629|NCT02732145|141709680|EQUIVALENCE|Question: Is there a difference in the incidence of recurrent attacks of sinusitis among patients from different groups?||||||0.0105|||||||Chi-squared|||Parameter: The difference in the incidence of recurrent attacks of sinusitis among patients from different groups.||||0.0105
71100630|NCT02732145|141709680|EQUIVALENCE|Question: Is there a difference in the incidence of HPV infection among patients from different groups, who were tested for HPV?||||||0.2128|||||||Chi-squared|||Parameter: The difference in the incidence of HPV infection among patients from different groups, who were tested for HPV.||||0.2128
71100631|NCT02732145|141709680|EQUIVALENCE|Question: Is there a difference in the incidence of abnormal PAP smear among patients from different groups?||||||0.0018|||||||Chi-squared|||Parameter: The difference in the incidence of abnormal PAP smear among patients from different groups.||||0.0018
71100632|NCT02732145|141709680|EQUIVALENCE|Question: Is there a difference in the incidence of genital warts among patients from different groups?||||||0.2524|||||||Chi-squared|||Parameter: The difference in the incidence of genital warts among patients from different groups.||||0.2524
71100633|NCT02732145|141709680|EQUIVALENCE|Question: Is there a difference in the incidence of conization or LETZ among patients from different groups?||||||0.2452|||||||Chi-squared|||Parameter: The difference in the incidence of conization or LETZ among patients from different groups.||||0.2452
71100634|NCT02732145|141709681|SUPERIORITY|Question: Is there a difference in the frequency of any previous treatment between patients with vulvar dermatosis and vulvodynia?||||||0.1583|||||||Chi-squared|||Parameter: The difference in the frequency of any previous treatment between patients with vulvar dermatosis and vulvodynia.||||0.1583
71000732|NCT02009930|141507966|OTHER|||||||0.13||||||Relationship between CAC and living in the dorms. CAC risk category (low, low-mod, mod-high, high, very high risk) and living in the dorms (\< 5 years, \> 5 years)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, living in the dorms - \<5 years/\> 5 years) expressed as a p-value||CAC risk category (low, low-mod, moderate - high, high, and very high)||||0.13
71000733|NCT02009930|141507967|OTHER|||||||0.44||||||Relationship between FRS and PT failures. FRS risk category (low, mod, mod-high, high, very high risk) and PT failures (with, without PT failure)|Fisher Exact|Relationship between 2 variables (FRS - each risk category, PT failure - with/without PT failure) expressed as a p-value||FRS risk categories (low, moderate, moderate-high, high, and very high)||||0.44
71000734|NCT02009930|141507967|OTHER|||||||0.49||||||Relationship between CAC and PT failures. CAC risk category (low, low-mod, mod-high, high, very high risk) and PT failures (with, without PT failure)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, PT failure - with/without PT failure) expressed as a p-value||CAC risk categories (low, low-moderate, mod -high, high, and very high)||||0.49
71100635|NCT02732145|141709681|SUPERIORITY|Question: Is there a difference in the frequency of previous local treatment with antifungals between the patients with vulvar dermatosis and vulvodynia?||||||0.038|||||||Chi-squared|||Parameter: The difference in the frequency of previous local treatment with antifungals among patients with vulvar dermatosis and vulvodynia.||||0.0380
71100636|NCT02732145|141709681|SUPERIORITY|Question: Is there a difference in the frequency of previous systemic treatment with antifungals between the patients with vulvar dermatosis and vulvodynia?||||||0.6468|||||||Chi-squared|||Parameter: The difference in the frequency of previous systemic treatment with antifungals among patients with vulvar dermatosis and vulvodynia.||||0.6468
71100637|NCT02732145|141709681|SUPERIORITY|Question: Is there a difference in the frequency of previous local treatment with antibiotics between the patients with vulvar dermatosis and vulvodynia?||||||0.467|||||||Chi-squared|||Parameter: The difference in the frequency of previous local treatment with antibiotics among patients with vulvar dermatosis and vulvodynia.||||0.4670
71100638|NCT02732145|141709681|SUPERIORITY|Question: Is there a difference in the frequency of previous systemic treatment with antibiotics between the patients with vulvar dermatosis and vulvodynia?||||||0.2131|||||||Chi-squared|||Parameter: The difference in the frequency of previous systemic treatment with antibiotics among patients with vulvar dermatosis and vulvodynia.||||0.2131
71000735|NCT02009930|141507968|OTHER|||||||0.11||||||Relationship between FRS and overall years of service. FRS risk category (low, mod, mod-high, high, very high risk) and overall years of service (15-19, 20-24, 25+)|Fisher Exact|Relationship between 2 variables (FRS - each risk category, overall years of service) expressed as a p-value||FRS risk categories (low, moderate, moderate -high, high, and very high)||||0.11
71000736|NCT02009930|141507968|OTHER|||||||0.003||||||Relationship between CAC and overall years of service. CAC risk category (low, low-mod, mod-high, high, very high risk) and overall years of service (15-19, 20-24, 25+)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, overall years of service) expressed as a p-value||CAC risk category (low, low-mod, mod-high, high, very high risk)||||0.003
71000737|NCT02009930|141507970|OTHER|||||||0.21||||||Relationship between CAC and metabolic syndrome. CAC risk category (low, low-mod, mod-high, high, very high risk) and metabolic syndrome (presence/absence of metabolic syndrome)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, metabolic syndrome - presence/absence) expressed as a p-value||CAC risk category (low, low-mod, mod-high, high, very high)||||0.21
71000738|NCT02009930|141507971|OTHER|||||||0.13||||||Relationship between CAC and living in the dorms. CAC risk category (low, low-mod, mod-high, high, very high risk) and living in the dorms (\< 5 years, \> 5 years)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, living in the dorms - \<5 years/\> 5 years) expressed as a p-value||CAC risk category (low, low-mod, moderate - high, high, and very high)||||0.13
71000739|NCT02009930|141507972|OTHER|||||||0.49||||||Relationship between CAC and PT failures. CAC risk category (low, low-mod, mod-high, high, very high risk) and PT failures (with, without PT failure)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, PT failure - with/without PT failure) expressed as a p-value||CAC risk categories (low, low-moderate, mod -high, high, and very high)||||0.49
71000740|NCT02009930|141507973|OTHER|||||||0.003||||||Relationship between CAC and overall years of service. CAC risk category (low, low-mod, mod-high, high, very high risk) and overall years of service (15-19, 20-24, 25+)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, overall years of service) expressed as a p-value||CAC risk category (low, low-mod, mod-high, high, very high risk)||||0.003
71000741|NCT03300427|141508006|SUPERIORITY||difference in least square means|-900.0||||0.7594|TWO_SIDED|95.0|-6781.7|4981.8|||ANCOVA|||The study hypothesis is that short-term therapy with sacubitril/valsartan added on standard HF therapy improves cardiac efficiency in subjects with systolic HF.||4981.8|-6781.7|0.7594
71000742|NCT03300427|141508008|SUPERIORITY||difference in least square means|-575.5||||0.8422|TWO_SIDED|95.0|-6365.5|5214.5|||ANCOVA|||The study hypothesis is that short-term therapy with sacubitril/valsartan added on standard HF therapy improves cardiac efficiency in subjects with systolic HF.||5214.5|-6365.5|0.8422
71000743|NCT00948428|141508075|EQUIVALENCE|If the 90% confidence interval around the difference between the Generic Imiquimod and Aldara Complete Clearance rates in the PP population were contained within the interval -0.20 to +0.20, and each of these rates was greater than, and statistically different (p\<0.05) from, the Vehicle rate in the ITT population, then Generic Imiquimod and Aldara were considered to be therapeutically equivalent|Mean Difference (Net)|-0.85|||||TWO_SIDED|90.0|-10.84|9.15||||||||9.15|-10.84|
71000744|NCT00948428|141508075|SUPERIORITY|||||||0.0001|||||||ANOVA|||Based on Intent-to-Treat Population||||0.0001
71000745|NCT00948428|141508076|EQUIVALENCE|If the 90% confidence interval around the difference between the Generic Imiquimod and Aldara Partial Clearance rates in the PP population were contained within the interval -0.20 to +0.20, then Generic Imiquimod and Aldara were considered to be therapeutically equivalent.|Mean Difference (Net)|-3.1|||||TWO_SIDED|90.0|-12.11|5.95||||||||5.95|-12.11|
71000746|NCT00948428|141508077|EQUIVALENCE|If the 90% confidence interval around the difference between the Generic Imiquimod and Aldara Complete Clearance rates in the ITT population were contained within the interval -0.20 to +0.20, then Generic Imiquimod and Aldara were considered to be therapeutically equivalent.|Mean Difference (Net)|-0.5|||||TWO_SIDED|90.0|-9.92|8.88||||||||8.88|-9.92|
71000747|NCT04839393|141508081|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Adjusted Geometric Mean Ratio (%)|108.86|||||TWO_SIDED|90.0|87.24|135.84|||Mixed Models Analysis|||||135.84|87.24|
71000748|NCT04839393|141508082|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Adjusted Geometric Mean Ratio|113.14|||||TWO_SIDED|90.0|89.34|143.28|||Mixed Models Analysis|||||143.28|89.34|
71000749|NCT04839393|141508083|OTHER|The ratio and 90% confidence interval were expressed as percentages|Adjusted Geometric Mean Ratio|38.73|||||TWO_SIDED|90.0|32.8|45.74|||Mixed Models Analysis|||The test treatment was PF-06865571 300 mg + PF-06882961 200 mg BID (Period 3 - Day 47), which was reported separately in comparison to the reference treatment of PF-06865571 300 mg (Period 1 - Day 1).||45.74|32.80|
71000750|NCT04839393|141508084|OTHER|The ratio and 90% confidence interval were expressed as percentages|Adjusted Geometric Mean Ratio|73.91|||||TWO_SIDED|90.0|67.95|80.4|||Mixed Models Analysis|||||80.40|67.95|
71000751|NCT04839393|141508085|OTHER|The ratio and 90% confidence interval were expressed as percentages|Adjusted Geometric Mean Ratio|73.2|||||TWO_SIDED|90.0|66.82|80.18|||Mixed Models Analysis|||||80.18|66.82|
71000752|NCT04839393|141508086|OTHER|The ratio and 90% confidence interval were expressed as percentages|Adjusted Geometric Mean Ratio|115.3|||||TWO_SIDED|90.0|85.37|155.73|||Mixed Models Analysis|||||155.73|85.37|
71000753|NCT04839393|141508087|OTHER|The ratio and 90% confidence interval were expressed as percentages|Adjusted Geometric Mean Ratio|118.64|||||TWO_SIDED|90.0|94.05|149.66|||Mixed Models Analysis|||||149.66|94.05|
71000754|NCT00671970|141508103|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
71000755|NCT00671970|141508104|SUPERIORITY_OR_OTHER|||||||0.613||95.0|||||Fisher Exact|||||||.613
71000756|NCT00671970|141508105|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
71000757|NCT00671970|141508106|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
71000758|NCT00671970|141508107|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
71000759|NCT00671970|141508108|SUPERIORITY_OR_OTHER|||||||0.179||95.0|||||Wilcoxon (Mann-Whitney)|||||||.179
71000760|NCT00671970|141508109|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Wilcoxon (Mann-Whitney)|||||||.008
71000761|NCT00633893|141508110|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3283|||<|0.0001|TWO_SIDED|95.0|0.2225|0.4844||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/all cause mortality to proportion of placebo participants with VTE/all cause mortality equal to 1.0. Participants with missing data were assumed to have experienced VTE/all cause mortality. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat (ITT) principle.||0.4844|0.2225|<0.0001
71000762|NCT00633893|141508110|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3615|||<|0.0001|TWO_SIDED|95.0|0.2475|0.5281||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/all cause mortality to proportion of placebo participants with VTE/all cause mortality equal to 1.0. Participants with missing data were assumed to have experienced VTE/all cause mortality. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat principle.||0.5281|0.2475|<0.0001
71000763|NCT00633893|141508111|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.2891|||<|0.0001|TWO_SIDED|95.0|0.1902|0.4395||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/VTE-related death to proportion of placebo participants with VTE/ VTE-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE/ VTE-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||0.4395|0.1902|<0.0001
71100639|NCT02732145|141709681|SUPERIORITY|Question: Is there a difference in the frequency of previous local treatment with corticosteroids between the patients with vulvar dermatosis and vulvodynia?||||||0|||||||Chi-squared|||Parameter: The difference in the frequency of previous local treatment with corticoids among patients with vulvar dermatosis and vulvodynia.||||0.0000
71100640|NCT02732145|141709681|SUPERIORITY|Question: Is there a difference in the frequency of previous systemic treatment with antidepressant between the patients with vulvar dermatosis and vulvodynia?||||||0.0962|||||||Chi-squared|||Parameter: The difference in the frequency of previous systemic treatment with antidepressant among patients with vulvar dermatosis and vulvodynia.||||0.0962
71000764|NCT00633893|141508111|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3774|||<|0.0001|TWO_SIDED|95.0|0.2577|0.5525||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/VTE-related death to proportion of placebo participants with VTE/ VTE-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE/ VTE-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||0.5525|0.2577|<0.0001
71000765|NCT00633893|141508112|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.2422|||<|0.0001|TWO_SIDED|95.0|0.1476|0.3975||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/all cause mortality to proportion of placebo participants with VTE/all cause mortality equal to 1.0. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat (ITT) principle.||0.3975|0.1476|<0.0001
71000766|NCT00633893|141508112|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.1861|||<|0.0001|TWO_SIDED|95.0|0.1062|0.3261||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/all cause mortality to proportion of placebo participants with VTE/all cause mortality equal to 1.0. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat (ITT) principle.||0.3261|0.1062|<0.0001
71008605|NCT02055976|141525232|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-57.962|STANDARD_ERROR_OF_MEAN|3.628|<|0.001|TWO_SIDED|95.0|-65.167|-50.758|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-50.758|-65.167|<0.001
71008606|NCT02055976|141525232|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-64.729|STANDARD_ERROR_OF_MEAN|3.682|<|0.001|TWO_SIDED|95.0|-72.039|-57.419|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-57.419|-72.039|<0.001
70924091|NCT05956002|141340292|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUClast for etrasimod 2 mg mini tablets mixed with water (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|85.86|||||TWO_SIDED|90.0|82.9|88.92|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in water vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||88.92|82.90|
70924092|NCT05956002|141340292|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUClast for etrasimod 2 mg mini tablets mixed with yogurt (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|93.24|||||TWO_SIDED|90.0|89.76|96.84|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in yogurt vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||96.84|89.76|
71000767|NCT00633893|141508113|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.2799|||<|0.0001|TWO_SIDED|95.0|0.1844|0.4247||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/CV-related death to proportion of placebo participants with VTE/CV-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE/CV-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||0.4247|0.1844|<0.0001
71000768|NCT00633893|141508113|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3653|||<|0.0001|TWO_SIDED|95.0|0.25|0.5338||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/CV-related death to proportion of placebo participants with VTE/CV-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE/CV-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||0.5338|0.2500|<0.0001
71000769|NCT00633893|141508114|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.2615|||<|0.0001|TWO_SIDED|95.0|0.1593|0.4292||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with nonfatal DVT to proportion of placebo participants with nonfatal DVT equal to 1.0. Participants with missing data were assumed to have experienced nonfatal DVT. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat (ITT) principle.||0.4292|0.1593|<0.0001
71000770|NCT00633893|141508114|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3972|||<|0.0001|TWO_SIDED|95.0|0.2595|0.6079||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with nonfatal DVT to proportion of placebo participants with nonfatal DVT equal to 1.0. Participants with missing data were assumed to have experienced nonfatal DVT. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||0.6079|0.2595|<0.0001
71000771|NCT00633893|141508115|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6087||||0.1084|TWO_SIDED|95.0|0.3653|1.0145||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with nonfatal PE to proportion of placebo participants with nonfatal PE equal to 1.0. Participants with missing data were assumed to have experienced nonfatal PE. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.0145|0.3653|0.1084
71000772|NCT00633893|141508115|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6846||||0.1329|TWO_SIDED|95.0|0.4164|1.1257||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with nonfatal PE to proportion of placebo participants with nonfatal PE equal to 1.0. Participants with missing data were assumed to have experienced nonfatal PE. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.1257|0.4164|0.1329
70924093|NCT05956002|141340293|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUCinf for etrasimod 2 mg mini tablets mixed with applesauce (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|94.36|||||TWO_SIDED|90.0|90.97|97.89|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in applesauce vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||97.89|90.97|
71000773|NCT00633893|141508116|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.647||||0.3059|TWO_SIDED|95.0|0.3543|1.1813||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE-related death to proportion of placebo participants with VTE-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.1813|0.3543|0.3059
70924094|NCT05956002|141340293|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUCinf for etrasimod 2 mg mini tablets mixed with chocolate pudding (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|94.75|||||TWO_SIDED|90.0|91.41|98.2|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in chocolate pudding vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||98.20|91.41|
70924095|NCT05956002|141340293|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUCinf for etrasimod 2 mg mini tablets mixed with water (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|85.44|||||TWO_SIDED|90.0|82.43|88.55|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in water vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||88.55|82.43|
70924096|NCT05956002|141340293|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUCinf for etrasimod 2 mg mini tablets mixed with yogurt (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|93.28|||||TWO_SIDED|90.0|89.61|97.1|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in yogurt vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||97.10|89.61|
70924097|NCT05956002|141340294|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of Cmax for etrasimod 2 mg mini tablets mixed with applesauce (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|94.7|||||TWO_SIDED|90.0|90.38|99.22|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in applesauce vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||99.22|90.38|
71000774|NCT00633893|141508116|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9416||||0.8288|TWO_SIDED|95.0|0.5458|1.6245||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE-related death to proportion of placebo participants with VTE-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.6245|0.5458|0.8288
71000775|NCT00633893|141508117|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5794||||0.1316|TWO_SIDED|95.0|0.3215|1.0443||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with CV-related death to proportion of placebo participants with CV-related death equal to 1.0. Participants with missing data were assumed to have experienced CV-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.0443|0.3215|0.1316
71000776|NCT00633893|141508117|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.8433||||0.5288|TWO_SIDED|95.0|0.4959|1.4341||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with CV-related death to proportion of placebo participants with CV-related death equal to 1.0. Participants with missing data were assumed to have experienced CV-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.4341|0.4959|0.5288
71008607|NCT02055976|141525232|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-36.428|STANDARD_ERROR_OF_MEAN|3.535|<|0.001|TWO_SIDED|95.0|-43.451|-29.405|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-29.405|-43.451|<0.001
71008608|NCT02055976|141525232|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-53.296|STANDARD_ERROR_OF_MEAN|3.538|<|0.001|TWO_SIDED|95.0|-60.325|-46.267|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-46.267|-60.325|<0.001
70924098|NCT05956002|141340294|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of Cmax for etrasimod 2 mg mini tablets mixed with chocolate pudding (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|92.72|||||TWO_SIDED|90.0|88.59|97.04|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in chocolate pudding vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||97.04|88.59|
71000777|NCT00633893|141508118|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6577||||0.2361|TWO_SIDED|95.0|0.3874|1.1169||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with all cause mortality to proportion of placebo participants with all cause mortality equal to 1.0. Participants with missing data were assumed to have experienced all cause mortality. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.1169|0.3874|0.2361
70924099|NCT05956002|141340294|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of Cmax for etrasimod 2 mg mini tablets mixed with water (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|87.24|||||TWO_SIDED|90.0|83.35|91.31|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in water vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||91.31|83.35|
71000778|NCT00633893|141508118|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7708||||0.3155|TWO_SIDED|95.0|0.4631|1.2832||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with all cause mortality to proportion of placebo participants with all cause mortality equal to 1.0. Participants with missing data were assumed to have experienced all cause mortality. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.2832|0.4631|0.3155
71000779|NCT00633893|141508120|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.485||||0.3925|TWO_SIDED|95.0|0.0891|2.6391||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with major bleeding to proportion of placebo participants with major bleeding equal to 1.0. Treated participants with at least one dose of study drug were included.||2.6391|0.0891|0.3925
71000780|NCT00633893|141508120|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.2457||||0.3551|TWO_SIDED|95.0|0.0269|2.2437||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with major bleeding to proportion of placebo participants with major bleeding equal to 1.0. Participants treated with at least one dose of study drug were included.||2.2437|0.0269|0.3551
71000781|NCT00633893|141508121|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2027||||0.5148|TWO_SIDED|95.0|0.6897|2.0975||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with major/clinically relevant non-major bleeding to proportion of placebo participants with major/clinically relevant non-major bleeding equal to 1.0.||2.0975|0.6897|0.5148
71000782|NCT00633893|141508121|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.616||||0.1412|TWO_SIDED|95.0|0.9554|2.7336||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with major/clinically relevant non-major bleeding to proportion of placebo participants with major/clinically relevant non-major bleeding equal to 1.0.||2.7336|0.9554|0.1412
71000783|NCT00633893|141508122|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2928||||0.3932|TWO_SIDED|95.0|0.7158|2.3348||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with clinically relevant non-major bleeding to proportion of placebo participants with clinically relevant non-major bleeding equal to 1.0.||2.3348|0.7158|0.3932
71000784|NCT00633893|141508122|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.8235||||0.0621||95.0|1.047|3.176||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with clinically relevant non-major bleeding to proportion of placebo participants with clinically relevant non-major bleeding equal to 1.0.||3.1760|1.0470|0.0621
71000785|NCT00633893|141508123|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2579||||0.1691|TWO_SIDED|95.0|0.9064|1.7457||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with minor bleeding to proportion of placebo participants with minor bleeding equal to 1.0.||1.7457|0.9064|0.1691
71000786|NCT00633893|141508123|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.6971||||0.0013|TWO_SIDED|95.0|1.2468|2.3102||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with minor bleeding to proportion of placebo participants with minor bleeding equal to 1.0.||2.3102|1.2468|0.0013
71042163|NCT01976728|141593680|SUPERIORITY||LSM difference|73.0||||0.3147|TWO_SIDED|95.0|-72.66|218.65||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in E2 levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 10 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||218.65|-72.66|0.3147
71000787|NCT00633893|141508124|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2374||||0.1466|TWO_SIDED|95.0|0.9276|1.6507||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with total bleeding to proportion of placebo participants with total bleeding equal to 1.0. Total bleeding was defined as any major, clinically relevant non-major, or minor bleeding.||1.6507|0.9276|0.1466
71000788|NCT00633893|141508124|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.6468||||0.0005|TWO_SIDED|95.0|1.2552|2.1606||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with total bleeding to proportion of placebo participants with total bleeding equal to 1.0. Total bleeding is any major, clinically relevant non-major, or minor bleeding.||2.1606|1.2552|0.0005
71000789|NCT02741310|141508132|OTHER|The clinical hypothesis was that there would be no clinically meaningful difference between the blood pressure effects of sumatriptan alone and the effects of a single dose of erenumab IV and sumatriptan concomitant therapy. A clinically meaningful difference was defined as the upper bound of the 90% confidence interval (CI) of treatment difference between erenumab IV and sumatriptan compared to sumatriptan alone being ≥ 5 mmHg on the time-weighted scale resting MAP.|LS Mean Difference|-0.04|||||TWO_SIDED|90.0|-2.16|2.08||||||A linear mixed effects regression analysis was performed to assess if the time-weighted average in MAP for erenumab with sumatriptan is similar to sumatriptan alone. A two-sided 90% confidence interval (equivalent to a one-sided upper 95% CI) for the mean treatment difference was calculated using a linear mixed-effects model with fixed effects for treatment and period and a random effect for subject.||2.08|-2.16|
71000790|NCT02741310|141508134|OTHER||Geometric Least Squares Mean Ratio|0.98|||||TWO_SIDED|90.0|0.93|1.03||||||The mean for each treatment was compared using a linear mixed effects model with group A (sumatriptan alone) as the reference treatment group. The linear mixed effects model included treatment (erenumab with sumatriptan vs sumatriptan alone) and period as a fixed effect and subject as a random effect.||1.03|0.93|
70924100|NCT05956002|141340294|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of Cmax for etrasimod 2 mg mini tablets mixed with yogurt (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|92.59|||||TWO_SIDED|90.0|88.24|97.17|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in yogurt vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||97.17|88.24|
71000791|NCT02741310|141508135|OTHER||Geometric Least Squares Mean Ratio|1.0|||||TWO_SIDED|90.0|0.96|1.05||||||The mean for each treatment was compared using a linear mixed effects model with group A (sumatriptan alone) as the reference treatment group. The linear mixed effects model included treatment (erenumab with sumatriptan vs sumatriptan alone) and period as a fixed effect and subject as a random effect.||1.05|0.96|
71000792|NCT02741310|141508136|OTHER||Geometric Least Squares Mean Ratio|0.95|||||TWO_SIDED|90.0|0.82|1.09||||||The mean for each treatment was compared using a linear mixed effects model with group A (sumatriptan alone) as the reference treatment group. The linear mixed effects model included treatment (erenumab with sumatriptan vs sumatriptan alone) and period as a fixed effect and subject as a random effect.||1.09|0.82|
71000793|NCT03417505|141508172|SUPERIORITY||||||<|0.01|||||||t-test, 1 sided|Paired t-test comparison||||||<0.01
71000794|NCT03417505|141508173|SUPERIORITY||||||<|0.05||||||Calculated p value was \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank comparisons, one-sided||||||<0.05
71000795|NCT03417505|141508174|SUPERIORITY||||||<|0.01|||||||t-test, 1 sided|paired 1-sided t-test||||||<0.01
71000796|NCT03417505|141508175|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank comparison, one sided p value||||||<0.01
71000797|NCT03417505|141508176|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05.|t-test, 1 sided|paired||||||>0.05
71042164|NCT01976728|141593680|SUPERIORITY||LSM difference|95.18||||0.229|TWO_SIDED|95.0|-63.01|253.36||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in E2 levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 15 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||253.36|-63.01|0.2290
71100641|NCT02732145|141709682|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test of the vulva among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test of the vulva among patients from different groups.||||0.0000
71000798|NCT03417505|141508177|SUPERIORITY||||||<|0.05||||||Calculated p value was \<0.05.|Wilcoxon (Mann-Whitney)|paired, 1-sided||||||<0.05
71000799|NCT03417505|141508178|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|paired, 1-sided||||||<0.01
71000800|NCT03417505|141508179|SUPERIORITY||||||<|0.05||||||Calculated p value was \<0.05.|Wilcoxon (Mann-Whitney)|paired, 1-sided||||||<0.05
71000801|NCT03417505|141508180|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05.|Wilcoxon (Mann-Whitney)|paired, 1-sided||||||>0.05
71000802|NCT03051217|141508196|SUPERIORITY||Estimated difference in responder rate|65.1|||||TWO_SIDED|95.0|48.22|81.9|||Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||81.90|48.22|
71000803|NCT03051217|141508196|SUPERIORITY||Estimated difference in responder rate|79.1|||||TWO_SIDED|95.0|65.1|93.17|||Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||93.17|65.10|
71000804|NCT03051217|141508196|SUPERIORITY||Odds Ratio (OR)|31.695|||<|0.0001|TWO_SIDED|97.5|5.129|195.877||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||195.877|5.129|<0.0001
71000805|NCT03051217|141508196|SUPERIORITY||Odds Ratio (OR)|79.112|||<|0.0001|TWO_SIDED|97.5|11.739|533.168||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||533.168|11.739|<0.0001
71000806|NCT03051217|141508197|SUPERIORITY||Estimated difference in responder rate|52.7|||||TWO_SIDED|95.0|29.95|75.39|||Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||75.39|29.95|
71000807|NCT03051217|141508197|SUPERIORITY||Estimated difference in responder rate|66.7|||||TWO_SIDED|95.0|43.34|90.15|||Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||90.15|43.34|
71042165|NCT01976728|141593680|SUPERIORITY||LSM difference|46.99||||0.5066|TWO_SIDED|95.0|-95.64|189.61||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in E2 levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 20 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||189.61|-95.64|0.5066
70924101|NCT02991534|141340335|SUPERIORITY||Odds Ratio (OR)|1.09||||0.003|TWO_SIDED|95.0|1.03|1.152|||Non-linear model with Logit|Non-linear model with Logit Link Function with Robust Standard Errors||||1.152|1.030|.003
70924102|NCT02991534|141340336|SUPERIORITY||Odds Ratio (OR)|1.0||||0.91|TWO_SIDED|95.0|0.976|1.022|||Non-linear model with Logit|Non-linear model with Logit Link Function with Robust Standard Errors||||1.022|0.976|0.91
70924103|NCT02991534|141340337|SUPERIORITY||Odds Ratio (OR)|1.06||||0.265|TWO_SIDED|95.0|0.959|1.165|||Non-linear model with Logit|Non-linear model with Logit Link Function with Robust Standard Errors||||1.165|.959|.265
70924104|NCT02991534|141340338|SUPERIORITY||Odds Ratio (OR)|1.01||||0.015|TWO_SIDED|95.0|1.002|1.022|||Non-linear model with Logit|Non-linear model with Logit Link Function with Robust Standard Errors||||1.022|1.002|0.015
71000808|NCT03051217|141508197|SUPERIORITY||Odds Ratio (OR)|38.193|||<|0.0001|TWO_SIDED|97.5|6.113|238.619||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||238.619|6.113|<0.0001
71000809|NCT03051217|141508197|SUPERIORITY||Odds Ratio (OR)|69.58|||<|0.0001|TWO_SIDED|97.5|11.138|434.659||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||434.659|11.138|<0.0001
71000810|NCT03051217|141508198|SUPERIORITY||Estimated difference in responder rate|53.6|||||TWO_SIDED|95.0|30.67|76.47|||Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||76.47|30.67|
71000811|NCT03051217|141508198|SUPERIORITY||Estimated difference in responder rate|75.5|||||TWO_SIDED|95.0|51.95|99.04|||Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||99.04|51.95|
71000812|NCT03051217|141508198|SUPERIORITY||Odds Ratio (OR)|38.696|||<|0.0001|TWO_SIDED|97.5|6.047|247.634||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||247.634|6.047|<0.0001
71000813|NCT03051217|141508198|SUPERIORITY||Odds Ratio (OR)|100.459|||<|0.0001|TWO_SIDED|97.5|15.54|649.437||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||649.437|15.540|<0.0001
71000814|NCT03051217|141508199|SUPERIORITY||Adjusted Mean Treatment Difference|-6.5|||<|0.0001|TWO_SIDED|97.5|-9.1|-3.844||p-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group and prior biologic exposure as factors and Baseline DLQI score as a covariate.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||-3.844|-9.100|<0.0001
71000815|NCT03051217|141508199|SUPERIORITY||Adjusted Mean Treatment Difference|-6.5|||<|0.0001|TWO_SIDED|97.5|-9.099|-3.91||p-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group and prior biologic exposure as factors and Baseline DLQI score as a covariate.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||-3.910|-9.099|<0.0001
71000816|NCT03051217|141508200|SUPERIORITY||Adjusted Mean Treatment Difference|-3.1|||<|0.0001|TWO_SIDED|95.0|-4.265|-2.002||p-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline Itch NRS with treatment group and prior biologic exposure as factors and Baseline Itch NRS as a covariate.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||-2.002|-4.265|<0.0001
71000817|NCT03051217|141508200|SUPERIORITY||Adjusted Mean Treatment Difference|-4.2|||<|0.0001|TWO_SIDED|95.0|-5.295|-3.069||p-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline Itch NRS with treatment group and prior biologic exposure as factors and Baseline Itch NRS as a covariate.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||-3.069|-5.295|<0.0001
71000818|NCT00109772|141508203|SUPERIORITY_OR_OTHER|||||||0.894||95.0|||||Cochran-Mantel-Haenszel|controlled for centers||||||.8940
71000819|NCT03437044|141508220|SUPERIORITY|||||||0.001|||||||ANCOVA|the corresponding baseline value of platelet reactivity was used as covariate||||||0.001
71000820|NCT03437044|141508221|SUPERIORITY||||||<|0.001|||||||ANCOVA|the corresponding baseline value of platelet reactivity was used as covariate||||||<0.001
71000821|NCT01359046|141508222|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.30
71000822|NCT01359046|141508223|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
71000823|NCT04539262|141508224|SUPERIORITY||Least Square Mean Difference by Day 7|-0.66|STANDARD_ERROR_OF_MEAN|0.4||0.1117|TWO_SIDED|95.0|-1.49|0.16||Least square (LS) Mean, Standard Error (SE), 95% CI and p-value were from Analysis of covariance (ANCOVA) with baseline viral load as a covariate.|ANCOVA|||||0.16|-1.49|0.1117
71000824|NCT04539262|141508224|SUPERIORITY||LS Mean Difference by Day 7|-0.35|STANDARD_ERROR_OF_MEAN|0.4||0.3793|TWO_SIDED|95.0|-1.16|0.46||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.46|-1.16|0.3793
71000825|NCT04539262|141508224|SUPERIORITY||LS Mean Difference by Day 7|-0.24|STANDARD_ERROR_OF_MEAN|0.37||0.5248|TWO_SIDED|95.0|-1.0|0.52||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate|ANCOVA|||||0.52|-1.00|0.5248
71000826|NCT04539262|141508224|SUPERIORITY||LS Mean Difference by Day 7|-0.25|STANDARD_ERROR_OF_MEAN|0.34||0.461|TWO_SIDED|95.0|-0.94|0.44|||ANCOVA|LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate||||0.44|-0.94|0.4610
71000827|NCT04539262|141508224|SUPERIORITY||LS Mean Difference by Day 7|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.5006|TWO_SIDED|95.0|-0.4|0.81||LS Mean (SE), 95% CI and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.81|-0.40|0.5006
71000828|NCT04539262|141508225|SUPERIORITY||LS Mean Difference by Day 7|0.33|STANDARD_ERROR_OF_MEAN|0.34||0.3417|TWO_SIDED|95.0|-0.37|1.02||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||1.02|-0.37|0.3417
71000829|NCT04539262|141508225|SUPERIORITY||LS Mean Difference by Day 7|0.49|STANDARD_ERROR_OF_MEAN|0.35||0.1803|TWO_SIDED|95.0|-0.24|1.21||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||1.21|-0.24|0.1803
71000830|NCT04539262|141508225|SUPERIORITY||LS Mean Difference by Day 7|-0.55|STANDARD_ERROR_OF_MEAN|0.35||0.1233|TWO_SIDED|95.0|-1.27|0.16||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.16|-1.27|0.1233
71000831|NCT04539262|141508225|SUPERIORITY||LS Mean Difference by Day 7|0.08|STANDARD_ERROR_OF_MEAN|0.35||0.8203|TWO_SIDED|95.0|-0.64|0.8||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.80|-0.64|0.8203
71000832|NCT04539262|141508225|SUPERIORITY||LS Mean Difference by Day 7|-0.12|STANDARD_ERROR_OF_MEAN|0.26||0.6458|TWO_SIDED|95.0|-0.65|0.41||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.41|-0.65|0.6458
71042166|NCT00966381|141593687|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71042167|NCT00966381|141593688|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71042168|NCT00966381|141593689|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71000833|NCT04539262|141508226|SUPERIORITY||LS Mean Difference by Day 7|-0.22|STANDARD_ERROR_OF_MEAN|0.4||0.5951|TWO_SIDED|95.0|-1.05|0.61||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.61|-1.05|0.5951
71000834|NCT04539262|141508226|SUPERIORITY|LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|LS Mean Difference by Day 7|-0.71|STANDARD_ERROR_OF_MEAN|0.4||0.0872|TWO_SIDED|95.0|-1.54|0.11|||ANCOVA|||||0.11|-1.54|0.0872
71000835|NCT04539262|141508226|SUPERIORITY||LS Mean Difference by Day 7|-0.19|STANDARD_ERROR_OF_MEAN|0.36||0.6031|TWO_SIDED|95.0|-0.94|0.56||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.56|-0.94|0.6031
71042169|NCT04894084|141593718|SUPERIORITY||Risk Ratio (RR)|0.18|||<|0.001|TWO_SIDED|95.0|0.07|0.49|||Poisson loglinear model|||||0.49|0.07|<0.001
71042170|NCT04894084|141593719|OTHER||Exact test in the binomial distribution|91.3|||<|0.0001|TWO_SIDED|95.0|72.0|99.0||"Low degree + Very low degree / Not at all were tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For questions answered on a 5-point scale the answers was grouped in 2 (e.g. higher or much higher against the rest of the answers)."||99|72|<0.0001
71042171|NCT04894084|141593720|OTHER||Exact test in the binomial distribution|78.3||||0.0106|TWO_SIDED|95.0|56.0|93.0||"Some degree, High degree and Very high degree were tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||For secondary endpoints an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For reliability answered on a 5-point scale the answers some, high, or very high degree was considered acceptable and grouped against answers of 'low or very low' degree of reliability.||93|56|0.0106
71000836|NCT04539262|141508226|SUPERIORITY||LS Mean Difference by Day 7|0.12|STANDARD_ERROR_OF_MEAN|0.37||0.7578|TWO_SIDED|95.0|-0.64|0.87||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.87|-0.64|0.7578
71000837|NCT04539262|141508226|SUPERIORITY||LS Mean Difference by Day 7|0.04|STANDARD_ERROR_OF_MEAN|0.26||0.8846|TWO_SIDED|95.0|-0.48|0.56||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.56|-0.48|0.8846
71000838|NCT02665468|141508262|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
71000839|NCT00444080|141508280|OTHER|||||||0.013|||||||Fisher Exact|||||||0.013
71042172|NCT04894084|141593721|OTHER||Exact test in the binomial distribution|95.7|||<|0.0001|TWO_SIDED|95.0|78.0|100.0||"Same, Better and Much better were tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||For secondary endpoints an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. For ability to move with test product it was tested if the proportion evaluating same or better was significantly different from 50% when using a 5% test level. The answers of 'same, better or much better' was grouped against the answers of 'worse or much worse' ability to move.||100|78|<0.0001
71000840|NCT01484561|141508294|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|0.92|||||TWO_SIDED|90.0|0.86|0.98|||ANCOVA||Analysis of covariance (ANCOVA) with change in logarithmic mGFR from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold Change (CP-690,550-placebo vs. placebo-placebo)||0.98|0.86|
71100642|NCT02732145|141709682|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 2h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 2h among patients from different groups.||||0.0000
71000841|NCT01484561|141508295|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|1.04|||||TWO_SIDED|90.0|0.97|1.11|||ANCOVA||ANCOVA with change in logarithmic mGFR from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.11|0.97|
71000842|NCT01484561|141508296|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|1.09|||||TWO_SIDED|90.0|1.02|1.16|||ANCOVA||ANCOVA with change in logarithmic mGFR from Period 2 baseline/the end of Period 1 as dependent variable, treatment and logarithmic Period 2 baseline/the end of Period 1 as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.16|1.02|
71000843|NCT01484561|141508297|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|0.94|||||TWO_SIDED|90.0|0.91|0.97|||ANCOVA||ANCOVA with change in logarithmic eGFR (MDRD) from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||0.97|0.91|
71000844|NCT01484561|141508298|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|0.99|||||TWO_SIDED|90.0|0.96|1.02|||ANCOVA||ANCOVA with change in logarithmic eGFR (MDRD) from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.02|0.96|
71000845|NCT01484561|141508299|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|1.04|||||TWO_SIDED|90.0|1.0|1.08|||ANCOVA||ANCOVA with change in logarithmic eGFR (MDRD) from Period 2 baseline/end of Period 1 as dependent variable, treatment and logarithmic Period 2 baseline/end of Period 1 as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.08|1.00|
71000846|NCT01484561|141508300|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|0.95|||||TWO_SIDED|90.0|0.92|0.98|||ANCOVA||ANCOVA with change in logarithmic eGFR (Cockcroft-Gault) from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||0.98|0.92|
71000847|NCT01484561|141508301|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|0.99|||||TWO_SIDED|90.0|0.97|1.02|||ANCOVA||ANCOVA with change in logarithmic eGFR (Cockcroft-Gault) from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.02|0.97|
71042173|NCT04894084|141593722|OTHER|Users worry of leakage given on a 5-point scale was analyzed by a proportional odds ratio model taken the paired design into consideration to compare the results from V1 and V2.|||||<|0.001|||||||Proportional odds ratio model|||||||<0.001
71042174|NCT04894084|141593723|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level."|Exact test in the binomial distribution|78.3||||0.0106|TWO_SIDED|95.0|56.0|93.0|||Exact test in the binomial distribution|||||93|56|0.0106
71042175|NCT04894084|141593724|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For questions answered on a 5-point scale the answers was grouped in 2 (e.g. higher or much higher against the rest of the answers)."|Exact test in the binomial distribution|65.2||||0.21|TWO_SIDED|95.0|43.0|84.0||"Higher degree and Much higher degree were tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||||84|43|0.21
71042176|NCT04894084|141593725|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For questions answered on a 5-point scale the answers was grouped in 2 (e.g. higher or much higher against the rest of the answers)."|Exact test in the binomial distribution|78.3||||0.0106|TWO_SIDED|95.0|56.0|93.0|||Exact test in the binomial distribution|||||93|56|0.0106
71042177|NCT04894084|141593726|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level."|Exact test in the binomial distribution|69.6||||0.093|TWO_SIDED|95.0|47.0|87.0|||Exact test in the binomial distribution|||||87|47|0.093
71042178|NCT04894084|141593727|OTHER|By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion with a positive response was significantly different from 50% when using a 5% test level.|Exact test in the binomial distribution|95.7|||<|0.0001|TWO_SIDED|95.0|78.0|100.0|||Exact test in the binomial distribution|||||100|78|<0.0001
71042179|NCT04894084|141593728|OTHER|By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion answering I felt more confident was significantly different from 50% when using a 5% test level.|Exact test in the binomial distribution|91.3|||<|0.0001|TWO_SIDED|95.0|72.0|99.0|||Exact test in the binomial distribution|||||99|72|<0.0001
70924105|NCT04401800|141340344|SUPERIORITY|||||||0.0002|||||||Binomial exact test|||||||0.0002
71000848|NCT01484561|141508302|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|1.04|||||TWO_SIDED|90.0|1.01|1.07|||ANCOVA||ANCOVA with change in logarithmic eGFR (Cockcroft-Gault) from Period 2 baseline/end of Period 1 as dependent variable, treatment and logarithmic Period 2 baseline/end of Period 1 as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.07|1.01|
71000849|NCT01484561|141508303|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|1.05|||||TWO_SIDED|90.0|1.02|1.08|||ANCOVA||ANCOVA with change in logarithmic creatinine from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.08|1.02|
71042180|NCT04894084|141593729|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For questions answered on a 5-point scale the answers was grouped in 2 (e.g. higher or much higher against the rest of the answers)."|Exact test in the binomial distribution|34.8||||0.21|TWO_SIDED|95.0|16.0|57.0||"Yes, to the better was tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||||57|16|0.21
71042181|NCT04894084|141593730|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For questions answered on a 5-point scale the answers was grouped in 2 (e.g. higher or much higher against the rest of the answers)."|Exact test in the binomial distribution|47.8||||1|TWO_SIDED|95.0|27.0|69.0||"Higher degree and Much higher degree were tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||||69|27|1.00
71042182|NCT04894084|141593731|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level."|Exact test in the binomial distribution|56.5||||0.678|TWO_SIDED|95.0|34.0|77.0|||Exact test in the binomial distribution|||||77|34|0.678
70924106|NCT04401800|141340346|SUPERIORITY||||||<|0.0001|||||||Binomial exact test|||||||< 0.0001
70924107|NCT04401800|141340347|SUPERIORITY||||||<|0.0001|||||||Binomial exact test|||ORR as Assessed by the Investigator||||< 0.0001
70924108|NCT04401800|141340347|SUPERIORITY||||||<|0.0001|||||||Binomial exact test|||ORR as Assessed by Central Site Imaging Facility||||< 0.0001
70924109|NCT04401800|141340348|SUPERIORITY||||||<|0.0001|||||||Binomial exact test|||ORR as Assessed by the Investigator||||< 0.0001
70924110|NCT04401800|141340348|SUPERIORITY|||||||0.0002|||||||Binomial exact test|||ORR as Assessed by Central Site Imaging Facility||||0.0002
71042183|NCT04894084|141593733|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For questions answered on a 5-point scale the answers was grouped in 2 (e.g. higher or much higher against the rest of the answers)."|Exact test in the binomial distribution|69.6||||0.0931|TWO_SIDED|95.0|47.0|87.0||"High degree and Very high degree were tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||||87|47|0.0931
71042184|NCT04894084|141593734|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level."|Exact test in the binomial distribution|87.0||||0.0005|TWO_SIDED|95.0|66.0|97.0|||Exact test in the binomial distribution|||||97|66|0.0005
71042185|NCT00317642|141593739|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9951|TWO_SIDED|95.0|0.78|1.28|||Log Rank|||Full Analysis Set (FAS) population||1.28|0.78|0.9951
71042186|NCT00317642|141593739|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.4674|TWO_SIDED|95.0|0.81|1.57|||Log Rank|||Participants stratified by calculated strata remission after first pre-study induction regimen (CR1) \< 6 months||1.57|0.81|0.4674
71042187|NCT00317642|141593739|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.3963|TWO_SIDED|95.0|0.58|1.24|||Log Rank|||Participants stratified by calculated strata CR1\>= 6 months||1.24|0.58|0.3963
71042188|NCT00317642|141593740|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Full Analysis Set (FAS) population - overall remission (OR)||||<0.0001
71042189|NCT00317642|141593740|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||Cochran-Mantel-Haenszel|||Full Analysis Set (FAS) population - Complete Remission (CR)||||0.0005
71042190|NCT00317642|141593740|SUPERIORITY_OR_OTHER|||||||0.0022||95.0|||||Fisher Exact|||Participants stratified by calculated strata - CR1 \<6 months \[Overall Remission (CR+CRi)\]||||0.0022
71042191|NCT00317642|141593740|SUPERIORITY_OR_OTHER|||||||0.0019||95.0|||||Fisher Exact|||Participants stratified by calculated strata - CR1 \>=6 months \[Overall Remission (CR+CRi)\]||||0.0019
71042192|NCT00317642|141593740|SUPERIORITY_OR_OTHER|||||||0.0353||95.0|||||Fisher Exact|||Participants stratified by calculated strata - CR1 \<6 months \[Complete Remission (CR)\]||||0.0353
71100643|NCT02732145|141709682|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 4h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 4h among patients from different groups.||||0.0000
71100644|NCT02732145|141709682|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 6h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 6h among patients from different groups.||||0.0000
71100645|NCT02732145|141709682|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 8h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 8h among patients from different groups.||||0.0000
71042193|NCT00317642|141593740|SUPERIORITY_OR_OTHER|||||||0.0096||95.0|||||Fisher Exact|||Participants stratified by calculated strata - CR1 \>=6 months \[Complete Remission (CR)\]||||0.0096
71042194|NCT00317642|141593745|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63||||0.0001|TWO_SIDED|95.0|0.49|0.8|||Log Rank|||Full Analysis Set (FAS) population.||0.80|0.49|0.0001
71042195|NCT00317642|141593745|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.0131|TWO_SIDED|95.0|0.49|0.93|||Log Rank|Comparison P-value is from a log-rank test with no strata||Participants stratified by randomization strata CR1 \<6 months||0.93|0.49|0.0131
71042196|NCT00317642|141593745|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.0022||95.0|0.4|0.83|||Log Rank|Comparison p-value is from a log-rank test with no strata.||Participants stratified by randomization strata CR1 \>=6 months||0.83|0.40|0.0022
71042197|NCT00317642|141593746|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.8209|TWO_SIDED|95.0|0.77|1.23|||Log Rank|||Full Analysis Set (FAS) population||1.23|0.77|0.8209
71042198|NCT00317642|141593746|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.5071|TWO_SIDED|95.0|0.81|1.53|||Log Rank|||||1.53|0.81|0.5071
71042199|NCT00317642|141593746|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.2906|TWO_SIDED|95.0|0.59|1.17|||Log Rank|||||1.17|0.59|0.2906
71042200|NCT00317642|141593747|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.49|0.79|||Log Rank|||Full Analysis Set (FAS) population.||0.79|0.49|<.0001
71042201|NCT00317642|141593747|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0486|TWO_SIDED|95.0|0.53|1.01|||Log Rank|||||1.01|0.53|0.0486
71042202|NCT00317642|141593747|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.52||||0.0002|TWO_SIDED|95.0|0.37|0.74|||Log Rank|||||0.74|0.37|0.0002
71042203|NCT00317642|141593748|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Full Analysis Set (FAS) population||||<0.0001
71042204|NCT00317642|141593748|SUPERIORITY_OR_OTHER|||||||0.0088||95.0|||||Fisher Exact|||Participants stratified by randomization strata CR1 \<6 months.||||0.0088
71042205|NCT00317642|141593748|SUPERIORITY_OR_OTHER|||||||0.0017||95.0|||||Fisher Exact|||Participants stratified by randomization strata CR1 \>=6 months||||0.0017
71042206|NCT00317642|141593749|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
71042207|NCT00317642|141593749|SUPERIORITY_OR_OTHER|||||||0.0506||95.0|||||Fisher Exact|||||||0.0506
71042208|NCT00317642|141593749|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
71042209|NCT01049412|141593752|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.55|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|90.0|-0.81|-0.29||The statistical significance level is 0.10.|Mixed Models Analysis|||||-0.29|-0.81|<0.001
71042210|NCT01049412|141593753|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.56|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|90.0|-0.83|-0.29||The statistical significance level is 0.10.|Mixed Models Analysis|||||-0.29|-0.83|<0.001
70924111|NCT04391894|141340426|SUPERIORITY||Least Squares Mean (LS Mean)|-1.1|STANDARD_ERROR_OF_MEAN|2.01||0.585|TWO_SIDED|95.0|-5.0|2.8|||Mixed Models Analysis|||||2.8|-5.0|0.585
70924112|NCT04391894|141340426|SUPERIORITY||Least Squares Mean (LS Mean)|-3.2|STANDARD_ERROR_OF_MEAN|2.0||0.107|TWO_SIDED|95.0|-7.01|0.7|||Mixed Models Analysis|||||0.7|-7.01|0.107
70924113|NCT04391894|141340426|SUPERIORITY||Least Squares Mean (LS Mean)|4.3|STANDARD_ERROR_OF_MEAN|2.02||0.033|TWO_SIDED|95.0|0.3|8.3|||Mixed Models Analysis|||||8.3|0.3|0.033
70924114|NCT04391894|141340427|SUPERIORITY||Least Squares Mean (LS Mean)|-0.2|STANDARD_ERROR_OF_MEAN|0.31||0.605|TWO_SIDED|95.0|-0.8|0.4|||Mixed Models Analysis|||||0.4|-0.8|0.605
71000850|NCT01484561|141508304|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|1.01|||||TWO_SIDED|90.0|0.98|1.04|||ANCOVA||ANCOVA with change in logarithmic creatinine from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.04|0.98|
71000851|NCT01484561|141508305|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|0.97|||||TWO_SIDED|90.0|0.94|1.0|||ANCOVA||ANCOVA with change in logarithmic creatinine from Period 2 baseline/the end of Period 1 as dependent variable, treatment and Period 2 baseline/the end of Period 1 as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.00|0.94|
71000852|NCT01484561|141508306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.16|STANDARD_ERROR_OF_MEAN|7.64|<|0.001|TWO_SIDED|90.0|23.6|48.73||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR20 Response at End of Period 1||48.73|23.60|<0.001
71000853|NCT01484561|141508306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.95|STANDARD_ERROR_OF_MEAN|8.14||0.05|TWO_SIDED|90.0|2.56|29.34||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR20 Response at End of Period 2||29.34|2.56|0.050
71000854|NCT01484561|141508307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.02|STANDARD_ERROR_OF_MEAN|5.94|<|0.001|TWO_SIDED|90.0|11.24|30.8||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR50 Response at End of Period 1||30.80|11.24|<0.001
71000855|NCT01484561|141508307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.0|STANDARD_ERROR_OF_MEAN|6.13||0.006|TWO_SIDED|90.0|6.92|27.08||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR50 Response at End of Period 2||27.08|6.92|0.006
71042211|NCT01049412|141593754|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.11|STANDARD_ERROR_OF_MEAN|0.1||0.242|TWO_SIDED|90.0|-0.28|0.05||The statistical significance level is 0.10.|Mixed Models Analysis|||||0.05|-0.28|0.242
71042212|NCT01049412|141593755|SUPERIORITY_OR_OTHER|||||||0.276||95.0||||"The statistical significance level is 0.10.~P-value is for HbA1c \<7.0%."|Fisher Exact|||||||0.276
71042213|NCT01049412|141593755|SUPERIORITY_OR_OTHER|||||||0.119||95.0||||"The statistical significance level is 0.10.~P-value is for HbA1c ≤6.5%."|Fisher Exact|||||||0.119
71042214|NCT01049412|141593757|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|0.3|STANDARD_ERROR_OF_MEAN|0.35||0.392|TWO_SIDED|90.0|-0.28|0.88||"The statistical significance level is 0.10.~P-value is for 0300 hour BG."|Mixed Models Analysis|||||0.88|-0.28|0.392
71042215|NCT01049412|141593757|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.24|STANDARD_ERROR_OF_MEAN|0.33||0.464|TWO_SIDED|90.0|-0.79|0.3||"The statistical significance level is 0.10.~P-value is for morning FBG."|Mixed Models Analysis|||||0.30|-0.79|0.464
70924115|NCT04391894|141340427|SUPERIORITY||Least Squares Mean (LS Mean)|-0.1|STANDARD_ERROR_OF_MEAN|0.31||0.646|TWO_SIDED|95.0|-0.7|0.5|||Mixed Models Analysis|||||0.5|-0.7|0.646
70924116|NCT04391894|141340427|SUPERIORITY||Least Squares Mean (LS Mean)|0.1|STANDARD_ERROR_OF_MEAN|0.31||0.847|TWO_SIDED|95.0|-0.5|0.7|||Mixed Models Analysis|||||0.7|-0.5|0.847
70924117|NCT04391894|141340428|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.2|0.2||||||||0.2|-0.2|
70924118|NCT04391894|141340428|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.3|0.1||||||||0.1|-0.3|
70924119|NCT04391894|141340428|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.2|0.2||||||||0.2|-0.2|
70924120|NCT04391894|141340429|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.2|0.2||||||||0.2|-0.2|
70924121|NCT04391894|141340429|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.3|0.1||||||||0.1|-0.3|
70924122|NCT04391894|141340429|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.1|0.6||||||||0.6|0.1|
70924123|NCT01889199|141340431|OTHER||Mean Difference (Final Values)|1.12||||0.004|TWO_SIDED|||||a priori threshold p\<0.05|t-test, 2 sided|||Only PCOS women were randomized to flutamide versus placebo; controls were not randomized A sample size of 11 per group (PCOS women versus controls) provided adequate power (approximately 80%) to detect effect sizes as small as 1.25 using a two-sample t-test (alpha=0.05, 2 tailed). A sample size of 5 per group (flutamide-treated versus placebo-treated PCOS women) also gave adequate power (approximately 80%) to detect effect sizes as small as 2 using a two-sample t-test (alpha=0.05, 2 tailed).||||0.004
70924124|NCT01889199|141340432|OTHER||Mean Difference (Net)|0.024|||||TWO_SIDED|||||||||6-month changes from baseline were compared between placebo- and flutamide-treated PCOS women using an unpaired Student's t-test to determine whether one group changed more than the other over this time interval.||||
71000856|NCT01484561|141508308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.56|STANDARD_ERROR_OF_MEAN|3.95|<|0.001|TWO_SIDED|90.0|12.06|25.05||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR70 Response at End of Period 1||25.05|12.06|<0.001
71000857|NCT01484561|141508308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.32|STANDARD_ERROR_OF_MEAN|3.53||0.038|TWO_SIDED|90.0|1.51|13.12||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR70 Response at End of Period 2||13.12|1.51|0.038
71000858|NCT01484561|141508309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|90.0|-1.53|-0.78||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.78|-1.53|<0.001
71000859|NCT01484561|141508310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.21||0.028|TWO_SIDED|90.0|-0.83|-0.12||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.12|-0.83|0.028
71000860|NCT01484561|141508311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|0.22||0.002|TWO_SIDED|90.0|0.32|1.04||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||1.04|0.32|0.002
71000861|NCT01484561|141508312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|90.0|-1.67|-0.84||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.84|-1.67|<0.001
71000862|NCT01484561|141508313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.23||0.031|TWO_SIDED|90.0|-0.88|-0.12||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.12|-0.88|0.031
71000863|NCT01484561|141508314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.24||0.002|TWO_SIDED|90.0|0.36|1.15||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||1.15|0.36|0.002
71042216|NCT01049412|141593757|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.48|STANDARD_ERROR_OF_MEAN|0.33||0.151|TWO_SIDED|90.0|-1.04|0.07||"The statistical significance level is 0.10.~P-value is for morning 2-hr postprandial BG."|Mixed Models Analysis|||||0.07|-1.04|0.151
71042217|NCT01049412|141593757|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.54|STANDARD_ERROR_OF_MEAN|0.3||0.079|TWO_SIDED|90.0|-1.05|-0.03||"The statistical significance level is 0.10.~P-value is for midday pre-meal BG."|Mixed Models Analysis|||||-0.03|-1.05|0.079
71042218|NCT01049412|141593757|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.52|STANDARD_ERROR_OF_MEAN|0.28||0.07|TWO_SIDED|90.0|-0.99|-0.05||"The statistical significance level is 0.10.~P-value is for midday 2-hr postprandial BG."|Mixed Models Analysis|||||-0.05|-0.99|0.070
71042219|NCT01049412|141593757|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.86|STANDARD_ERROR_OF_MEAN|0.32||0.008|TWO_SIDED|90.0|-1.39|-0.34||"The statistical significance level is 0.10.~P-value is for evening pre-meal BG."|Mixed Models Analysis|||||-0.34|-1.39|0.008
71100646|NCT02732145|141709682|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 10h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 10h among patients from different groups.||||0.0000
71100647|NCT02732145|141709682|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 12h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 12h among patients from different groups.||||0.0000
71100648|NCT02732145|141709682|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test of the vulva in patients with vulvar dermatosis versus normal vulva?||||||0.0009|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test of the vulva in patients with vulvar dermatosis versus normal vulva.||||0.0009
71100649|NCT02732145|141709682|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 2h in patients with vulvar dermatosis versus normal vulva?||||||0.0289|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 2h in patients with vulvar dermatosis versus normal vulva.||||0.0289
71042220|NCT01049412|141593757|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.89|STANDARD_ERROR_OF_MEAN|0.29||0.003|TWO_SIDED|90.0|-1.38|-0.41||"The statistical significance level is 0.10.~P-value is for evening 2-hr postprandial BG."|Mixed Models Analysis|||||-0.41|-1.38|0.003
71042221|NCT01049412|141593757|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-1.1|STANDARD_ERROR_OF_MEAN|0.33||0.001|TWO_SIDED|90.0|-1.64|-0.55||"The statistical significance level is 0.10.~P-value is for bed time BG."|Mixed Models Analysis|||||-0.55|-1.64|0.001
71042222|NCT01049412|141593762|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||The statistical significance level is 0.10.|Negative Binomial Model|||||||0.037
71000864|NCT01484561|141508315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.09|STANDARD_ERROR_OF_MEAN|2.02||0.045|TWO_SIDED|90.0|-7.44|-0.74||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.74|-7.44|0.045
71042223|NCT01049412|141593763|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.47|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|90.0|-0.69|-0.25||The statistical significance level is 0.10.|Mixed Models Analysis|||||-0.25|-0.69|<0.001
71000865|NCT01484561|141508316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|1.76||0.936|TWO_SIDED|90.0|-2.78|3.06||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||3.06|-2.78|0.936
71000866|NCT01484561|141508317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.23|STANDARD_ERROR_OF_MEAN|1.93||0.03|TWO_SIDED|90.0|1.04|7.42||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||7.42|1.04|0.030
71000867|NCT01484561|141508318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.26|STANDARD_ERROR_OF_MEAN|1.03||0.03|TWO_SIDED|90.0|-3.96|-0.55||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.55|-3.96|0.030
71042224|NCT04205162|141593769|OTHER|||||||0.331|||||||Wilcoxon (Mann-Whitney)|||Comparison of etafilcon A||||0.331
70924125|NCT01889199|141340434|OTHER||Mean Difference (Net)|0.04||||0.04|TWO_SIDED||||||t-test, 2 sided|||6-month changes from baseline were compared between placebo- and flutamide-treated PCOS women using an unpaired Student's t-test to determine whether one group changed more than the other over this time interval.||||0.040
70924126|NCT01889199|141340435|OTHER|||||||0.034|||||||t-test, 2 sided|||6-month changes from baseline were compared between placebo- and flutamide-treated PCOS women using an unpaired Student's t-test to determine whether one group changed more than the other over this time interval.||||0.034
70924127|NCT02323321|141340438|OTHER|The primary hypothesis for this study is that the true (success) proportion of transplanted patients meeting the primary effectiveness endpoint, patient survival at day 30 post-transplantation and absence of severe PGD (left or right ventricle) in the first 24 hours post-transplantation, is greater than the Performance Goal value of 0.65.|Proportion|88.0|||<|0.0001|TWO_SIDED|95.0|78.4|94.4|||one-sided exact binomial test|||||94.4|78.4|<0.0001
71042225|NCT04205162|141593769|OTHER|||||||0.122|||||||Wilcoxon (Mann-Whitney)|||Comparison of verofilcon A||||0.122
71042226|NCT04205162|141593770|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Comparison of etafilcon A||||0.130
70924128|NCT00446225|141340439|SUPERIORITY||Hazard Ratio (HR)|0.42||||0.0001|TWO_SIDED|95.0|0.27|0.64|||Log Rank|||||0.64|0.27|0.0001
70924129|NCT00446225|141340441|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.043|TWO_SIDED|95.0|0.36|0.99|||Log Rank|||||0.99|0.36|0.043
70924130|NCT04986501|141340485|SUPERIORITY||||||<|0.01|||||||t-test, 1 sided|||||||<0.01
70924131|NCT04986501|141340487|SUPERIORITY||||||<|0.01|||||||t-test, 1 sided|||||||<0.01
70924132|NCT02814838|141340498|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.3303|TWO_SIDED|95.0|-0.14|0.42|||Student's t test for unpaired samples|||Transformed AUC was analyzed with Student t-test for unpaired data using PROC TTEST within SAS® to compare Ladarixin and placebo groups. The estimated treatment difference between Ladarixin and placebo was also presented together with the corresponding 95% confidence interval.||0.42|-0.14|0.3303
70924133|NCT02814838|141340499|SUPERIORITY|The comparisons between groups on 2-hour AUC C-peptide efficacy endpoint was carried-out using a mixed linear model where the log(x+1) transformed 2-hour AUC C-peptide was the dependent variable, while treatment group, visit, treatment by visit interaction were the fixed factors of the model and patient will be the random effect. An unstructured covariance matrix for each patient is considered and the Kenward-Roger adjustment is used for the degrees of freedom.|adjusted mean difference|0.0984||||0.517|TWO_SIDED|95.0|-0.2028|0.3995|||Mixed Models Analysis|||at FUP week 26||0.3995|-0.2028|0.517
70924134|NCT02814838|141340499|SUPERIORITY|The comparisons between groups on 2-hour AUC C-peptide efficacy endpoint was carried-out using a mixed linear model where the log(x+1) transformed 2-hour AUC C-peptide was the dependent variable, while treatment group, visit, treatment by visit interaction were the fixed factors of the model and patient will be the random effect. An unstructured covariance matrix for each patient is considered and the Kenward-Roger adjustment is used for the degrees of freedom.|adjusted mean difference|-0.0486||||0.7999|TWO_SIDED|95.0|-0.4294|0.3322|||Mixed Models Analysis|||At FUP week 52||0.3322|-0.4294|0.7999
70924135|NCT02814838|141340500|SUPERIORITY||adjusted mean difference|12.0411||||0.2224|TWO_SIDED|95.0|-7.3823|31.4644|||Mixed Models Analysis|||at week 13||31.4644|-7.3823|0.2224
70924136|NCT02814838|141340500|SUPERIORITY||adjusted mean difference|8.4803||||0.3931|TWO_SIDED|95.0|-11.0935|28.0541|||Mixed Models Analysis|||At week 26||28.0541|-11.0935|0.3931
70924137|NCT02814838|141340500|SUPERIORITY||adjusted mean difference|-2.9502||||0.7664|TWO_SIDED|95.0|-22.5476|16.6473|||Mixed Models Analysis|||At week 52||16.6473|-22.5476|0.7664
70924138|NCT02814838|141340501|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with Daily Insulin Requirement (IU/kg/day) as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|-0.048||||0.2225|TWO_SIDED|95.0|-0.1257|0.0298|||Mixed Models Analysis|||at week 13||0.0298|-0.1257|0.2225
70924139|NCT02814838|141340501|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with Daily Insulin Requirement (IU/kg/day) as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|-0.0369||||0.551|TWO_SIDED|95.0|-0.1596|0.0858|||Mixed Models Analysis|||at week 26||0.0858|-0.1596|0.551
70924140|NCT02814838|141340501|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with Daily Insulin Requirement (IU/kg/day) as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|-0.063||||0.2501|TWO_SIDED|95.0|-0.1712|0.0453|||Mixed Models Analysis|||at week 52||0.0453|-0.1712|0.2501
70924141|NCT02814838|141340502|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with HbA1c (%) as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|-0.1494||||0.6252|TWO_SIDED|95.0|-0.7514|0.4526|||Mixed Models Analysis|||at FU week 13||0.4526|-0.7514|0.6252
70924142|NCT02814838|141340502|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with HbA1c (%) as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|-0.2804||||0.366|TWO_SIDED|95.0|-0.8904|0.3297|||Mixed Models Analysis|||At FU week 26||0.3297|-0.8904|0.366
71042227|NCT04205162|141593770|OTHER|||||||0.924|||||||Wilcoxon (Mann-Whitney)|||Comparison of verofilcon A||||0.924
71042228|NCT01011556|141593771|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 3.5% was used.|Difference in Least Square Means|-7.17|||<|0.001|TWO_SIDED|90.0|-8.489|-5.851|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.||||-5.851|-8.489|<0.001
71042229|NCT01011556|141593771|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 3.5% was used.|Difference in Least Square Means|-7.48|||<|0.001|TWO_SIDED|90.0|-8.822|-6.144|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.||||-6.144|-8.822|<0.001
71042230|NCT01011556|141593771|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 3.5% was used.|Difference in Least Square Means|-6.17|||<|0.001|TWO_SIDED|90.0|-7.448|-4.891|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.||||-4.891|-7.448|<0.001
71042231|NCT01011556|141593772|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-4.58|||<|0.001|TWO_SIDED|90.0|-5.716|-3.452|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.||||-3.452|-5.716|<0.001
71042232|NCT01011556|141593772|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-3.87|||<|0.001|TWO_SIDED|90.0|-5.006|-2.727|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.||||-2.727|-5.006|<0.001
71042233|NCT01011556|141593772|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-3.56|||<|0.001|TWO_SIDED|90.0|-4.652|-2.464|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.||||-2.464|-4.652|<0.001
71042234|NCT01011556|141593773|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-4.53|STANDARD_ERROR_OF_MEAN|0.687|<|0.001|TWO_SIDED|90.0|-5.663|-3.392||p-value is for change in BMD at 6 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\*visit interaction. Repeat measure occurred at each visit.||||-3.392|-5.663|<0.001
71042235|NCT01011556|141593773|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-3.94|STANDARD_ERROR_OF_MEAN|0.692|<|0.001|TWO_SIDED|90.0|-5.086|-2.8||p-value is for change in BMD at 6 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\*visit interaction. Repeat measure occurred at each visit.||||-2.800|-5.086|<0.001
71042236|NCT01011556|141593773|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-3.53|STANDARD_ERROR_OF_MEAN|0.665|<|0.001|TWO_SIDED|90.0|-4.627|-2.43||p-value is for change in BMD at 6 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\*visit interaction. Repeat measure occurred at each visit.||||-2.430|-4.627|<0.001
71042237|NCT01011556|141593773|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-7.5|STANDARD_ERROR_OF_MEAN|0.818|<|0.001|TWO_SIDED|90.0|-8.856|-6.151||p-value is for change in BMD at 12 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\*visit interaction. Repeat measure occurred at each visit.||||-6.151|-8.856|<0.001
71042238|NCT01011556|141593773|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-7.46|STANDARD_ERROR_OF_MEAN|0.83||0.001|TWO_SIDED|90.0|-8.835|-6.091||p-value for change in BMD at 12 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\*visit interaction. Repeat measure occurred at each visit.||||-6.091|-8.835|0.001
71042239|NCT01011556|141593773|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-6.19|STANDARD_ERROR_OF_MEAN|0.802||0.001|TWO_SIDED|90.0|-7.51|-4.86||p-value is for change in BMD at 12 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\*visit interaction. Repeat measure occurred at each visit.||||-4.860|-7.510|0.001
71042240|NCT01011556|141593774|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||<0.001
71042241|NCT01011556|141593774|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||<0.001
71042242|NCT01011556|141593774|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||<0.001
71100650|NCT02732145|141709682|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 4h in patients with vulvar dermatosis versus normal vulva?||||||0.0134|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 4h in patients with vulvar dermatosis and normal vulva.||||0.0134
71100651|NCT02732145|141709682|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 6h in patients with vulvar dermatosis versus normal vulva?||||||0.0037|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 6h in patients with vulvar dermatosis and normal vulva.||||0.0037
71100652|NCT02732145|141709682|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 8h in patients with vulvar dermatosis and normal vulva?||||||0.008|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 8h in patients with vulvar dermatosis and normal vulva.||||0.0080
71042243|NCT01011556|141593774|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.||||||<0.001
71042244|NCT01011556|141593774|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.||||||<0.001
71042245|NCT01011556|141593774|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.||||||0.003
71042246|NCT01011556|141593774|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.||||||<0.001
71042247|NCT01011556|141593774|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.||||||<0.001
71042248|NCT01011556|141593774|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.||||||0.029
71042249|NCT01011556|141593774|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.||||||<0.001
71042250|NCT01011556|141593774|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.||||||<0.001
71042251|NCT01011556|141593774|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.||||||0.047
71042252|NCT01011556|141593775|SUPERIORITY_OR_OTHER|||||||0.822||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||0.822
71042253|NCT01011556|141593775|SUPERIORITY_OR_OTHER|||||||0.406||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||0.406
71042254|NCT01011556|141593775|SUPERIORITY_OR_OTHER|||||||0.312||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||0.312
71042255|NCT01011556|141593775|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.||||||<0.001
71100653|NCT02732145|141709682|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 10h in patients with vulvar dermatosis versus normal vulva?||||||0.0579|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 10h in patients with vulvar dermatosis and normal vulva.||||0.0579
71100654|NCT02732145|141709682|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 12h in patients with vulvar dermatosis versus normal vulva?||||||0.072|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 12h in patients with vulvar dermatosis and normal vulva.||||0.0720
71000868|NCT01484561|141508319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|1.11||0.472|TWO_SIDED|90.0|-2.64|1.04||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||1.04|-2.64|0.472
71000869|NCT01484561|141508320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46|STANDARD_ERROR_OF_MEAN|1.03||0.158|TWO_SIDED|90.0|-0.24|3.15||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||3.15|-0.24|0.158
71000870|NCT01484561|141508321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.73|STANDARD_ERROR_OF_MEAN|3.71|<|0.001|TWO_SIDED|90.0|-19.87|-7.59||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-7.59|-19.87|<0.001
71000871|NCT01484561|141508322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.89|STANDARD_ERROR_OF_MEAN|4.04||0.029|TWO_SIDED|90.0|-15.58|-2.21||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-2.21|-15.58|0.029
71000872|NCT01484561|141508323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.84|STANDARD_ERROR_OF_MEAN|2.98||0.107|TWO_SIDED|90.0|-0.1|9.77||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||9.77|-0.10|0.107
71000873|NCT01484561|141508324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.9|STANDARD_ERROR_OF_MEAN|4.87||0.001|TWO_SIDED|90.0|-23.96|-7.84||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-7.84|-23.96|0.001
71000874|NCT01484561|141508325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7|STANDARD_ERROR_OF_MEAN|4.95||0.251|TWO_SIDED|90.0|-13.9|2.5||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||2.50|-13.90|0.251
71000875|NCT01484561|141508326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.19|STANDARD_ERROR_OF_MEAN|4.42||0.023|TWO_SIDED|90.0|2.87|17.52||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||17.52|2.87|0.023
71000876|NCT01484561|141508327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.12|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|90.0|-21.58|-8.67||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-8.67|-21.58|<0.001
71000877|NCT01484561|141508328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|4.77||0.616|TWO_SIDED|90.0|-10.3|5.5||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||5.50|-10.30|0.616
71000878|NCT01484561|141508329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.72|STANDARD_ERROR_OF_MEAN|4.17||0.003|TWO_SIDED|90.0|5.82|19.62||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||19.62|5.82|0.003
71000879|NCT01484561|141508330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3|STANDARD_ERROR_OF_MEAN|4.52|<|0.001|TWO_SIDED|90.0|-22.78|-7.82||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-7.82|-22.78|<0.001
71000880|NCT01484561|141508331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.62|STANDARD_ERROR_OF_MEAN|4.83||0.247|TWO_SIDED|90.0|-13.62|2.38||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||2.38|-13.62|0.247
70924143|NCT02814838|141340502|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with HbA1c (%) as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|-0.2063||||0.5026|TWO_SIDED|95.0|-0.3992|0.8118|||Mixed Models Analysis|||At FU week 52||0.8118|-0.3992|0.5026
70924144|NCT02814838|141340503|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with C-peptide (nmol/L) actual value as dependent variable, treatment, visit, time, treatment by visit interaction, time by visit interaction, treatment by visit by time interaction as fixed effects and time by visit interaction is specified in repeated statement.|adjusted mean difference|0.0242||||0.2527|TWO_SIDED|95.0|-0.0174|0.0658|||Mixed Models Analysis|||at week 13||0.0658|-0.0174|0.2527
71000881|NCT01484561|141508332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.68|STANDARD_ERROR_OF_MEAN|4.67||0.04|TWO_SIDED|90.0|1.95|17.41||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||17.41|1.95|0.040
71000882|NCT01484561|141508333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|90.0|-0.56|-0.23||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.23|-0.56|<0.001
71000883|NCT01484561|141508334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.09||0.053|TWO_SIDED|90.0|-0.31|-0.03||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.03|-0.31|0.053
71000884|NCT01484561|141508335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.07||0.003|TWO_SIDED|90.0|0.1|0.35||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||0.35|0.10|0.003
71000885|NCT03371251|141508337|SUPERIORITY||Observed Difference vs. Placebo|2.0||||0.8434|TWO_SIDED|90.0|-14.5|18.5|||Pearson's chi-square test|||Statistical Analysis: SRI-4 Response||18.5|-14.5|0.8434
71000886|NCT03371251|141508337|SUPERIORITY||Observed Difference vs. Placebo|2.0||||0.8434|TWO_SIDED|90.0|-14.5|18.5|||Pearson's chi-square test|||Statistical Analysis: \>= 4-Point Reduction from Baseline in SLEDAI-2K Global Score||18.5|-14.5|0.8434
71000887|NCT03371251|141508337|SUPERIORITY||Observed Difference vs. Placebo|17.7||||0.0141|TWO_SIDED|90.0|4.5|30.9|||Pearson's chi-square test|||Statistical Analysis: No New BILAG A or More than One BILAG B Organ Score Compared with Baseline||30.9|4.5|0.0141
71000888|NCT03371251|141508337|SUPERIORITY||Observed Difference vs. Placebo|17.7||||0.0141|TWO_SIDED|90.0|4.5|30.9|||Pearson's chi-square test|||Statistical Analysis: No Deterioration from Baseline in PGA by \>=30mm||30.9|4.5|0.0141
71000889|NCT03371251|141508353|SUPERIORITY||Observed Difference vs. Placebo|-2.6||||0.7985|TWO_SIDED|90.0|-19.8|14.5|||Pearson's chi-square test|||||14.5|-19.8|0.7985
71000890|NCT03371251|141508354|SUPERIORITY||Observed Difference vs. Placebo|-6.9||||0.3498|TWO_SIDED|90.0|-22.9|9.8|||Pearson's chi-square test|||Statistical Analysis for Overall||9.8|-22.9|0.3498
71000891|NCT03371251|141508355|SUPERIORITY||Observed Difference vs. Placebo|-21.8||||0.0072|TWO_SIDED|90.0|-36.2|-7.4|||Pearson's chi-square test|||Statistical analysis for Overall||-7.4|-36.2|0.0072
71000892|NCT03371251|141508355|SUPERIORITY||Observed Difference vs. Placebo|-17.7||||0.0141|TWO_SIDED|90.0|-30.9|-4.5|||Pearson's chi-square test|||Statistical Analysis for Day 210||-4.5|-30.9|0.0141
71000893|NCT03371251|141508356|SUPERIORITY||Observed Difference vs. Placebo|4.9||||0.6107|TWO_SIDED|90.0|-10.7|20.5|||Pearson's chi-square test|||||20.5|-10.7|0.6107
71000894|NCT03371251|141508357|SUPERIORITY||Observed Difference vs. Placebo|15.4||||0.1237|TWO_SIDED|90.0|-0.9|31.8|||Pearson's chi-square test|||||31.8|-0.9|0.1237
71000895|NCT03371251|141508358|SUPERIORITY||Observed Difference vs. Placebo|-13.7||||0.0581|TWO_SIDED|90.0|-26.7|-0.7|||Pearson's chi-square test|||Statistical Analysis for Overall||-0.7|-26.7|0.0581
71000896|NCT03371251|141508358|SUPERIORITY||Observed Difference vs. Placebo|-14.3||||0.0471|TWO_SIDED|90.0|-31.2|3.2|||Pearson's chi-square test|||Statistical Analysis for Day 210||3.2|-31.2|0.0471
71000897|NCT03371251|141508359|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|-0.3|STANDARD_ERROR_OF_MEAN|0.78||0.6596|TWO_SIDED|90.0|-1.63|0.94|||ANCOVA||This is based on LS Means|Statistical Analysis for CLASI-A (Total Activity)||0.94|-1.63|0.6596
71000898|NCT03371251|141508359|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.3|STANDARD_ERROR_OF_MEAN|0.33||0.4105|TWO_SIDED|90.0|-0.27|0.81|||ANCOVA||This is based on LS Means|Statistical Analysis for CLASI-B (Total Damage)||0.81|-0.27|0.4105
71042256|NCT01011556|141593775|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.||||||<0.001
71042257|NCT01011556|141593775|SUPERIORITY_OR_OTHER|||||||0.952||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.||||||0.952
71042258|NCT01011556|141593775|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.||||||<0.001
71042259|NCT01011556|141593775|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.||||||0.011
71042260|NCT01011556|141593775|SUPERIORITY_OR_OTHER|||||||0.997||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.||||||0.997
71042261|NCT01011556|141593775|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.||||||0.003
71042262|NCT01011556|141593775|SUPERIORITY_OR_OTHER|||||||0.112||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.||||||0.112
71042263|NCT01011556|141593775|SUPERIORITY_OR_OTHER|||||||0.988||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.||||||0.988
71042264|NCT01011556|141593776|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||<0.001
70924145|NCT02814838|141340503|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with C-peptide (nmol/L) actual value as dependent variable, treatment, visit, time, treatment by visit interaction, time by visit interaction, treatment by visit by time interaction as fixed effects and time by visit interaction is specified in repeated statement.|adjusted mean difference|0.0236||||0.2743|TWO_SIDED|95.0|-0.0188|0.066|||Mixed Models Analysis|||at week 26||0.066|-0.0188|0.2743
71042265|NCT01011556|141593776|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||<0.001
70924146|NCT02814838|141340503|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with C-peptide (nmol/L) actual value as dependent variable, treatment, visit, time, treatment by visit interaction, time by visit interaction, treatment by visit by time interaction as fixed effects and time by visit interaction is specified in repeated statement.|adjusted mean difference|-0.0059||||0.7856|TWO_SIDED|95.0|-0.0485|0.0367|||Mixed Models Analysis|||at week 52||0.0367|-0.0485|0.7856
70924147|NCT02814838|141340504|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with Glucose (mmol/L) actual value as dependent variable, treatment, visit, time, treatment by visit interaction, time by visit interaction, treatment by visit by time interaction as fixed effects and time by visit interaction is specified in repeated statement.|adjusted mean difference|-0.0253||||0.9307|TWO_SIDED|95.0|-0.5986|0.548|||Mixed Models Analysis|||at week 13||0.548|-0.5986|0.9307
70924148|NCT02814838|141340504|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with Glucose (mmol/L) actual value as dependent variable, treatment, visit, time, treatment by visit interaction, time by visit interaction, treatment by visit by time interaction as fixed effects and time by visit interaction is specified in repeated statement.|adjusted mean difference|-0.7236||||0.0139|TWO_SIDED|95.0|-1.2989|-0.1483|||Mixed Models Analysis|||At week 26||-0.1483|-1.2989|0.0139
70924149|NCT02814838|141340504|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with Glucose (mmol/L) actual value as dependent variable, treatment, visit, time, treatment by visit interaction, time by visit interaction, treatment by visit by time interaction as fixed effects and time by visit interaction is specified in repeated statement.|adjusted mean difference|-0.5979||||0.0432|TWO_SIDED|95.0|-1.1775|-0.0184|||Mixed Models Analysis|||at week 52||-0.0184|-1.1775|0.0432
70924150|NCT02814838|141340506|SUPERIORITY|||||||0.1171|||||||Fisher Exact|||at week 13||||0.1171
70924151|NCT02814838|141340506|SUPERIORITY|||||||0.6586|||||||Fisher Exact|||At week 26||||0.6586
70924152|NCT02814838|141340506|SUPERIORITY|||||||0.5056|||||||Fisher Exact|||At week 52||||0.5056
70924153|NCT02814838|141340507|SUPERIORITY|||||||0.0779|||||||Fisher Exact|||at week 13||||0.0779
70924154|NCT02814838|141340507|SUPERIORITY|||||||0.0248|||||||Fisher Exact|||At week 26||||0.0248
70924155|NCT02814838|141340507|SUPERIORITY|||||||0.4504|||||||Fisher Exact|||At week 52||||0.4504
70924156|NCT02814838|141340508|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with log(AUC(15-120 minutes)+1) of C-peptide above fasting value as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|0.1402||||0.4163|TWO_SIDED|95.0|-0.2015|0.4819|||Mixed Models Analysis|||At week 13||0.4819|-0.2015|0.4163
70924157|NCT02814838|141340508|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with log(AUC(15-120 minutes)+1) of C-peptide above fasting value as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|0.177||||0.3575|TWO_SIDED|95.0|-0.2039|0.558|||Mixed Models Analysis|||At week 26||0.558|-0.2039|0.3575
70924158|NCT02814838|141340508|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with log(AUC(15-120 minutes)+1) of C-peptide above fasting value as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|0.0451||||0.8386|TWO_SIDED|95.0|-0.3948|0.4851|||Mixed Models Analysis|||At week 52||0.4851|-0.3948|0.8386
70924159|NCT02814838|141340509|SUPERIORITY|Transformed AUC was analyzed with Student t-test for unpaired data using PROC TTEST within SAS® to compare Ladarixin and placebo groups. The estimated treatment difference between Ladarixin and placebo was also presented together with the corresponding 95% confidence interval.|Mean Difference (Final Values)|0.354|||=|0.1114|TWO_SIDED|95.0|-0.09|0.75|||t-test, 2 sided|||At week 13||0.75|-0.09|= 0.1114
70924160|NCT02814838|141340509|SUPERIORITY|Transformed AUC was analyzed with Student t-test for unpaired data using PROC TTEST within SAS® to compare Ladarixin and placebo groups. The estimated treatment difference between Ladarixin and placebo was also presented together with the corresponding 95% confidence interval.|Mean Difference (Final Values)|0.502|||=|0.0411|TWO_SIDED|95.0|0.02|0.98|||t-test, 2 sided|||At week 26||0.98|0.02|= 0.0411
71000899|NCT03371251|141508360|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.8|STANDARD_ERROR_OF_MEAN|4.11||0.8546|TWO_SIDED|90.0|-6.07|7.58|||ANCOVA||This is based on LS Means|Statistical Analysis for Day 210||7.58|-6.07|0.8546
71000900|NCT03371251|141508361|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.5|STANDARD_ERROR_OF_MEAN|0.7||0.4455|TWO_SIDED|90.0|-0.63|1.71|||ANCOVA||This is based on LS Means|Statistical Analysis for Sum of Swelling for Day 210||1.71|-0.63|0.4455
71000901|NCT03371251|141508361|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.9|STANDARD_ERROR_OF_MEAN|0.94||0.3367|TWO_SIDED|90.0|-0.65|2.47|||ANCOVA||This is based on LS Means|Statistical Analysis for Sum of Tenderness for Day 210||2.47|-0.65|0.3367
71000902|NCT03371251|141508361|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.8|STANDARD_ERROR_OF_MEAN|0.66||0.255|TWO_SIDED|90.0|-0.34|1.86|||ANCOVA||This is based on LS Means|Statistical Analysis for Sum of Active Joints for Day 210||1.86|-0.34|0.2550
71000903|NCT03371251|141508362|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.8|STANDARD_ERROR_OF_MEAN|0.68||0.2498|TWO_SIDED|90.0|-0.34|1.93|||ANCOVA||This is based on LS Means|||1.93|-0.34|0.2498
71000904|NCT03371251|141508363|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.0|STANDARD_ERROR_OF_MEAN|0.04||0.2558|TWO_SIDED|90.0|-0.02|0.12|||ANCOVA||This is based on LS Means|Statistical Analysis for Day 180||0.12|-0.02|0.2558
71042266|NCT01011556|141593776|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||<0.001
71042267|NCT00263887|141593787|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||ANCOVA|||The main effect ANCOVA model includes the change from baseline to endpoint as the dependent variable, treatment and center as fixed factors, change in logarithm of total lung volume and baseline measurement as covariates.||||0.049
71000905|NCT03371251|141508364|SUPERIORITY||Hazard Ratio (HR)|0.39||||0.0479|TWO_SIDED|90.0|0.18|0.88|||Log Rank||Hazard rate of BOS161721 120 mg / Hazard rate of placebo|||0.88|0.18|0.0479
71000906|NCT03371251|141508366|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|4.4|STANDARD_ERROR_OF_MEAN|16.4||0.7898|TWO_SIDED|90.0|-22.92|31.7|||ANOVA||This is based on LS Means|||31.70|-22.92|0.7898
71000907|NCT03371251|141508367|SUPERIORITY||Hazard Ratio (HR)|0.33||||0.0083|TWO_SIDED|90.0|0.16|0.68|||Log-Rank Test (2-Sided)||Hazard rate of BOS161721 120mg / Hazard rate of placebo|||0.68|0.16|0.0083
71000908|NCT00291187|141508371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.5|||<|0.001|TWO_SIDED|95.0|-33.1|-9.9|||ANCOVA|||||-9.9|-33.1|<0.001
71000909|NCT00291187|141508371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.3|||<|0.001|TWO_SIDED|95.0|-37.8|-14.7|||ANCOVA|||||-14.7|-37.8|<0.001
71000910|NCT00291187|141508371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.8|||<|0.001|TWO_SIDED|95.0|-34.2|-11.3|||ANCOVA|||||-11.3|-34.2|<0.001
71000911|NCT00291187|141508372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.2||||0.017|TWO_SIDED|95.0|-44.1|-4.3|||ANCOVA|||||-4.3|-44.1|0.017
71000912|NCT00291187|141508372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.7||||0.001|TWO_SIDED|95.0|-53.6|-13.9|||ANCOVA|||||-13.9|-53.6|0.001
71000913|NCT00291187|141508372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.4||||0.081|TWO_SIDED|95.0|-37.0|2.1|||ANCOVA|||||2.1|-37.0|0.081
71000914|NCT00291187|141508373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.7||||0.002|TWO_SIDED|95.0|13.0|54.5|||ANCOVA|||||54.5|13.0|0.002
71000915|NCT00291187|141508373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.9|||<|0.001|TWO_SIDED|95.0|27.2|68.6|||ANCOVA|||||68.6|27.2|<0.001
71000916|NCT00291187|141508373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.6||||0.005|TWO_SIDED|95.0|9.1|50.0|||ANCOVA|||||50.0|9.1|0.005
71000917|NCT00291187|141508374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.1||||0.006|TWO_SIDED|95.0|-18.9|-3.3|||ANCOVA|||||-3.3|-18.9|0.006
71000918|NCT00291187|141508374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.3|||<|0.001|TWO_SIDED|95.0|-22.1|-6.5|||ANCOVA|||||-6.5|-22.1|<0.001
71000919|NCT00291187|141508374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.3||||0.002|TWO_SIDED|95.0|-20.0|-4.6|||ANCOVA|||||-4.6|-20.0|0.002
71000920|NCT03168555|141508377|EQUIVALENCE|compares visit 1 with visit 2||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
71000921|NCT03168555|141508379|EQUIVALENCE|compares visit 1 with visit 2||||||0.63|||||||paired t-test|lognormalized values||compares visit 1 with visit 2||||0.63
71000922|NCT03168555|141508380|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
71000923|NCT03168555|141508381|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
71000924|NCT03168555|141508382|OTHER|Spearman correlation||||||0.41|||||||Spearman correlation|||||||0.41
71000925|NCT03168555|141508383|OTHER|Spearman correlation||||||0.35|||||||Spearman correlation|||||||0.35
71000926|NCT03168555|141508383|OTHER|||||||0.03|||||||Spearman correlation|||||||0.03
71000927|NCT03168555|141508384|EQUIVALENCE|comparing visit 1 with visit 2||||||0.36|||||||paired t-test|||||||0.36
71000928|NCT03168555|141508385|SUPERIORITY|||||||0.29|||||||paired t-test|||||||0.29
71000929|NCT03168555|141508386|OTHER|Spearman correlation||||||0.73|||||||Spearman correlation|||||||0.73
71000930|NCT03168555|141508386|OTHER|||||||0.77|||||||Spearman correlation|||||||0.77
71000931|NCT03168555|141508387|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.80
71000932|NCT01515488|141508430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.3|STANDARD_ERROR_OF_MEAN|5.2|<|0.0005|TWO_SIDED|95.0|22.1|42.6|||t-test, 2 sided|DF=331.2||||42.6|22.1|<0.0005
71000933|NCT04445688|141508447|SUPERIORITY||difference in Least Squares Mean|-7.3|||<|0.0001|TWO_SIDED|95.0|-10.2|-4.4|||ANOVA|||||-4.4|-10.2|<0.0001
71000934|NCT04445688|141508448|SUPERIORITY||difference in Least Squares Mean|-21.8|||<|0.0001|TWO_SIDED|95.0|-29.5|-14.1|||ANOVA|||||-14.1|-29.5|<0.0001
71000935|NCT04445688|141508449|SUPERIORITY||difference in Least Squares Mean|-7.3|||<|0.0001|TWO_SIDED|95.0|-10.5|-4.2|||ANOVA|||||-4.2|-10.5|<0.0001
71000936|NCT01262599|141508456|SUPERIORITY|Applies to primary and secondary outcomes: Data were analyzed using one-way analysis of variance, one-way repeated measures analysis of variance, t test, or Mann-Whitney rank sum test, as appropriate. (SigmaStat 3.5; Systat Software, Inc., San Jose, Calif.). Intention-to-treat using last value carried forward was used for missing data.|||||<|0.01|||||||ANOVA|||Before the start of this study, a sample size analysis, assuming a clinically meaningful 50± 40 percent (mean ± SD) decrease in pain scores from pulsed electromagnetic field treatment, suggested that a minimum of 11 patients per group were needed.||||<0.01
71000937|NCT01711658|141508460|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.3436|TWO_SIDED|95.0|0.56|1.46|||Log Rank|One-sided significance level = 0.1803|Reference level = IMRT + cisplatin + placebo|Hazard ratio (lapatinib/placebo) set at 0.65 (35% reduction), 1-sided alpha 0.20 (final test at 0.1803 accounting for 1 interim analysis), logrank test, 80% power, 69 events in 128 randomized (142 total enrolled) patients required. Final analysis at 67 (of 69) events drops power to 79%.||1.46|0.56|0.3436
71000938|NCT01711658|141508461|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.5836|TWO_SIDED|95.0|0.61|1.86|||Log Rank|One-sided significance level = 0.05|Reference level = IMRT + cisplatin + placebo|||1.86|0.61|0.5836
71000939|NCT01711658|141508462|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.1743|TWO_SIDED|95.0|0.25|1.65|||Log Rank|One-sided significance level = 0.05|Reference level = IMRT + cisplatin + placebo|||1.65|0.25|0.1743
71000940|NCT01711658|141508463|SUPERIORITY|||||||0.7989|||||||Fisher Exact|Two-sided significance level = 0.05||||||0.7989
71000941|NCT01711658|141508464|SUPERIORITY|||||||0.3728||||||IMRT|Fisher Exact|Two-sided significance level = 0.05||||||0.3728
71000942|NCT01711658|141508464|OTHER|||||||0.7781||||||Cisplatin|Fisher Exact|Two-sided significance level = 0.05||||||0.7781
71000943|NCT01711658|141508464|OTHER|||||||0.8||||||Pre-IMRT lapatinib/placebo|Fisher Exact|Two-sided significance level = 0.05||||||0.8000
71000944|NCT01711658|141508464|OTHER|||||||0.6459||||||Concurrent lapatinib/placebo|Fisher Exact|Two-sided significance level = 0.05||||||0.6459
71000945|NCT01711658|141508464|OTHER|||||||0.4792||||||Maintenance lapatinib/placebo|Fisher Exact|Two-sided significance level = 0.05||||||0.4792
71000946|NCT01711658|141508465|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.6735|TWO_SIDED|95.0|0.62|2.17|||Log Rank|One-sided significance level = 0.05|Reference level = IMRT + cisplatin + placebo|||2.17|0.62|0.6735
71042268|NCT00779402|141593794|OTHER||Hazard Ratio (HR)|0.997||||0.65|TWO_SIDED|95.0|0.693|1.433|||Log Rank|Log Rank Test (two sided) stratified by Gleason Score and Radiation Therapy||||1.433|0.693|0.65
71042269|NCT00693225|141593796|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
71042270|NCT01315028|141593799|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.05
71042271|NCT01315028|141593800|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||ANOVA|||Parametric and non-parametric descriptive data were summarised and presented. All data analyses were based on the Intention to Treat (ITT) principle. For the main analysis, Repeated Measures Analysis of Variance was performed to identify signals suggesting treatment effects on the outcome measures. Effect sizes were also calculated in order to further examine suggestive trends in the data indicating appropriate outcomes for further research.||||0.996
71042272|NCT01315028|141593801|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
71042273|NCT01315028|141593802|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
71042274|NCT00476593|141593879|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED|95.0||||Hypothesis: the use of diclofenac/dexamethasone does not influence macular thickness in treated eyes compared with untreated eyes of same subject.|t-test, 2 sided|The possible effect of both anti-inflammatory medications was tested in relation to participants' age and gender||Subjects who received diclofenac or dexamethasone eye drops in one eye. Macular thickness in both were compared between same subjects' eyes after 3 day's treatment. Diclofenac and dexamethasone treated eyes were not compared with each other, but with the contralateral eye of same subject by a paired Student's t-test in each medication group||||0.018
71042275|NCT00476593|141593879|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED|95.0|||||t-test, 2 sided|||Patient's healthy eyes were compared with sex and age matched healthy controls with Two Sample Student't t-test. Null hypothesis was that quiet, currently unaffected eyes of patients had same macular thickness as age and sex matched controls.||||0.024
71042276|NCT03712124|141593932|OTHER||Least Square (LS) Mean Difference|-6.44||||0.903|TWO_SIDED|95.0|-116.18|103.31|||ANCOVA|||Analysis was performed using an analysis of covariance (ANCOVA) model with change from baseline at Day 14 as the dependent variable and baseline maximum tolerated volume and treatment as covariates.||103.31|-116.18|0.9030
71042277|NCT03712124|141593933|OTHER||LS Mean Difference|98.45||||0.0042|TWO_SIDED|95.0|35.81|161.08|||ANCOVA|||Analysis was performed using ANCOVA model with change from baseline at Day 28 as the dependent variable and baseline maximum tolerated volume and treatment as covariates.||161.08|35.81|0.0042
70924161|NCT02814838|141340509|SUPERIORITY|Transformed AUC was analyzed with Student t-test for unpaired data using PROC TTEST within SAS® to compare Ladarixin and placebo groups. The estimated treatment difference between Ladarixin and placebo was also presented together with the corresponding 95% confidence interval.|Mean Difference (Final Values)|0.223|||=|0.4506|TWO_SIDED|95.0|-0.37|0.82|||t-test, 2 sided|||At week 52||0.82|-0.37|= 0.4506
71042278|NCT00551616|141593956|OTHER||% of observed pregnancies|1.78|||<|0.001|TWO_SIDED|95.0|1.04|2.98|||Chi-squared||Expected pregnancy rate = 5.58%|Comparison of % of observed pregnancies vs % of expected pregnancies based on Trussell 1998||2.98|1.04|<0.001
71042279|NCT00551616|141593956|OTHER||% of observed pregnancies|2.59|||<|0.001|TWO_SIDED|95.0|1.68|3.94|||Chi-squared||Expected pregnancy rate = 5.43%|Comparison of % of observed pregnancies vs % of expected pregnancies based on Trussell 1998||3.94|1.68|<0.001
71042280|NCT04718129|141593979|SUPERIORITY||Mean Difference (Net)|0.044|STANDARD_ERROR_OF_MEAN|0.021||0.048|TWO_SIDED|95.0|0.003|0.085|||Regression, Linear|||||.085|.003|.048
71042281|NCT02030535|141593994|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.219|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001|TWO_SIDED|95.0|0.187|0.252||Mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; patient baseline and period baseline as covariates; patient as a random effect|Mixed models repeated measures analysis|Kenward-Roger approximation of denominator degrees of freedom. Compound symmetry covariance structure for within-patient variation|Tio+Olo 5/5μg minus Placebo.|||0.252|0.187|<0.0001
71042282|NCT02030535|141593994|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.252|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001|TWO_SIDED|95.0|0.22|0.284||Mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; patient baseline and period baseline as covariates; patient as a random effect|Mixed models repeated measures analysis|Kenward-Roger approximation of denominator degrees of freedom. Compound symmetry covariance structure for within-patient variation.|Tiotropium 5μg + Olodaterol 5μg minus Placebo.|||0.284|0.220|<0.0001
71042283|NCT02030535|141593994|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.033|STANDARD_ERROR_OF_MEAN|0.016|||TWO_SIDED|95.0|-0.065|-0.001|||||Tio+Olo 5/5μg minus Tiotropium 5μg + Olodaterol 5μg.|Descriptive comparison. Statistical Analyses 1 \& 2 were included in the hierarchical testing sequence (alpha protected), and analysis 3 was not included in the hierarchical testing sequence (not alpha protected)||-0.001|-0.065|
71042284|NCT00292227|141594012|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.75||||||90.0|-2.63|1.12|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.12|-2.63|
71042285|NCT00292227|141594013|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.01||||||90.0|-2.21|2.19|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.19|-2.21|
71100655|NCT02732145|141709683|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Outer Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Outer Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71100656|NCT02732145|141709683|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Middle Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71100657|NCT02732145|141709683|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Inner Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71000947|NCT01142193|141508471|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.85|||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<.001
71000948|NCT01142193|141508471|SUPERIORITY_OR_OTHER||Median Difference (Net)|18.5|||||TWO_SIDED|95.0|8.53|28.1|||Hodges-Lehmann|||||28.1|8.53|
71000949|NCT01142193|141508472|SUPERIORITY_OR_OTHER||Difference in Percentages|14.7||||0.013|||||||Fisher Exact|||||||0.013
71000950|NCT01142193|141508473|SUPERIORITY_OR_OTHER||Difference in Percentages|16.3||||0.007|||||||Cochran-Mantel-Haenszel|Analysis was stratified by Geographic Region.||||||0.007
71000951|NCT01142193|141508474|SUPERIORITY_OR_OTHER||Median Difference (Net)|25.36|||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70924162|NCT02814838|141340510|SUPERIORITY||Adjusted mean difference|0.3631||||0.1847|TWO_SIDED|95.0|-0.1817|0.908|||Mixed Models Analysis|||Week 13 Analysis is based on a linear mixed model for repeated measures with log(AUC(15-120 minutes)+1) of C-peptide above fasting value as dependent variable, treatment, visit and treatment by visit interaction||0.908|-0.1817|0.1847
71000952|NCT01142193|141508475|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.85|||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71000953|NCT01142193|141508479|SUPERIORITY_OR_OTHER||Median Difference (Net)|23.61||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71000954|NCT01142193|141508480|SUPERIORITY_OR_OTHER||Difference in Percentages|13.4||||0.048|||||||Cochran-Mantel-Haenszel|Analysis was stratified by Geographic Region.||||||0.048
71000955|NCT00383708|141508483|OTHER||||||<|0.0001|||||||Exact test|One-sided p value||The percentage of subjects (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||<0.0001
71000956|NCT00383708|141508484|OTHER|||||||0.1654||||||One-sided p value|Exact test|||The percentage of subjects in the subgroup previously treated with pegvisomant (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||0.1654
71100658|NCT02732145|141709683|SUPERIORITY|Question: Is there a difference in the incidence of erythema of the Outer Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Outer Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71100659|NCT02732145|141709683|SUPERIORITY|Question: Is there a difference in the incidence of erythema of the Middle Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71000957|NCT00383708|141508484|OTHER|||||||0.0115||||||One-sided p value|Exact test|||The percentage of subjects in the subgroup previously treated with lanreotide Autogel (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||0.0115
71000958|NCT00383708|141508484|OTHER|||||||0.0003||||||One-sided p value|Exact test|||The percentage of subjects in the subgroup previously treated with octreotide LAR (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||0.0003
71000959|NCT00383708|141508485|OTHER|||||||0.084||||||One-sided p value|Exact test|||The percentage of subjects in the subgroup diabetic subjects (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||0.084
71000960|NCT00383708|141508485|OTHER||||||<|0.0001||||||One-sided p value|Exact test|||The percentage of subjects in the subgroup non diabetic subjects (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||<0.0001
71000961|NCT00383708|141508486|OTHER||||||<|0.0001||||||One-sided p-value|Exact test|||The percentage of subjects in the subgroup 'while taking final dose during co-administration' (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||<0.0001
71000962|NCT00383708|141508486|OTHER||||||<|0.0001||||||One-sided p-value|Exact test|||The percentage of subjects in the subgroup 'at any time during co-administration' (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||<0.0001
71000963|NCT00669032|141508522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|ONE_SIDED||||||Chi-squared|||||||0.004
71000964|NCT00669032|141508523|SUPERIORITY_OR_OTHER_LEGACY|||||||0.525|TWO_SIDED||||||Chi-squared|||||||0.525
71000965|NCT00669032|141508524|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|TWO_SIDED||||||Chi-squared|||||||0.030
71100660|NCT02732145|141709683|SUPERIORITY|Question: Is there a difference in the incidence of erythema of the Inner Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71100661|NCT02732145|141709683|SUPERIORITY|Question: Is there a difference in the incidence of excoriations of the Outer Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of excoriations of the Outer Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71100662|NCT02732145|141709683|SUPERIORITY|Question: Is there a difference in the incidence of fissures the Middle Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of fissures of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71100663|NCT02732145|141709683|SUPERIORITY|Question: Is there a difference in the incidence of rhagades of the Outer Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of rhagades of the Outer Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
70924163|NCT02814838|141340510|SUPERIORITY||Adjusted mean difference|0.6304||||0.031|TWO_SIDED|95.0|0.0609|1.1998|||Mixed Models Analysis|||Week 26 Analysis is based on a linear mixed model for repeated measures with log(AUC(15-120 minutes)+1) of C-peptide above fasting value as dependent variable, treatment, visit and treatment by visit interaction||1.1998|0.0609|0.031
71000966|NCT00669032|141508525|SUPERIORITY_OR_OTHER_LEGACY|||||||0.049|TWO_SIDED||||||Chi-squared|||||||0.049
71000967|NCT00669032|141508526|SUPERIORITY_OR_OTHER_LEGACY|||||||0.049|TWO_SIDED||||||Chi-squared|||||||0.049
71000968|NCT00669032|141508527|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||Chi-squared|||||||0.002
71000969|NCT00669032|141508528|SUPERIORITY_OR_OTHER_LEGACY|||||||0.021|TWO_SIDED||||||Chi-squared|||||||0.021
71000970|NCT00669032|141508529|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025|TWO_SIDED||||||Chi-squared|||||||0.025
71000971|NCT00669032|141508530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|TWO_SIDED||||||Chi-squared|||||||0.023
71000972|NCT00669032|141508531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||Chi-squared|||||||0.002
71000973|NCT00669032|141508532|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9129|TWO_SIDED||||||Chi-squared|||||||0.9129
71000974|NCT03627494|141508585|OTHER||Ratio|0.93|||||TWO_SIDED|90.0|0.84|1.03|||||"Analysis was performed using Mixed Effect Model with treatment and period as fixed effect and participant as random effect. Variance Components covariance structure was used."|||1.03|0.84|
71000975|NCT03627494|141508586|OTHER||Ratio|0.93|||||TWO_SIDED|90.0|0.84|1.04|||||"Analysis was performed using Mixed Effect Model with treatment and period as fixed effect and participant as random effect. Variance Components covariance structure was used."|||1.04|0.84|
71000976|NCT03627494|141508587|OTHER||Ratio|0.89|||||TWO_SIDED|90.0|0.79|1.01|||||"Analysis was performed using Mixed Effect Model with treatment and period as fixed effect and participant as random effect. Variance Components covariance structure was used."|||1.01|0.79|
71000977|NCT03906136|141508605|SUPERIORITY||Odds Ratio (OR)|0.69||||0.119|TWO_SIDED|95.0|0.43|1.1|||Regression, Logistic|||Week 24||1.10|0.43|0.119
71000978|NCT03906136|141508606|SUPERIORITY||Odds Ratio (OR)|0.59||||0.029|TWO_SIDED|95.0|0.37|0.95|||Regression, Logistic|||Week 12||0.95|0.37|0.029
71000979|NCT03906136|141508607|SUPERIORITY||Odds Ratio (OR)|0.71||||0.154|TWO_SIDED|95.0|0.45|1.14|||Regression, Logistic|||Week 12||1.14|0.45|0.154
71000980|NCT03906136|141508607|SUPERIORITY||Odds Ratio (OR)|0.87||||0.562|TWO_SIDED|95.0|0.54|1.39|||Regression, Logistic|||Week 24||1.39|0.54|0.562
71000981|NCT03906136|141508608|SUPERIORITY||Odds Ratio (OR)|0.55||||0.029|TWO_SIDED|95.0|0.32|0.94|||Regression, Logistic|||Week 12||0.94|0.32|0.029
71000982|NCT03906136|141508608|SUPERIORITY||Odds Ratio (OR)|0.74||||0.264|TWO_SIDED|95.0|0.44|1.25|||Regression, Logistic|||Week 24||1.25|0.44|0.264
71000983|NCT03906136|141508609|SUPERIORITY||Odds Ratio (OR)|0.49||||0.008|TWO_SIDED|95.0|0.29|0.83|||Regression, Logistic|||Week 12||0.83|0.29|0.008
71000984|NCT03906136|141508609|SUPERIORITY||Odds Ratio (OR)|0.47||||0.005|TWO_SIDED|95.0|0.28|0.8|||Regression, Logistic|||Week 24||0.80|0.28|0.005
71000985|NCT03906136|141508610|SUPERIORITY||Odds Ratio (OR)|0.72||||0.263|TWO_SIDED|95.0|0.4|1.28|||Regression, Logistic|||Week 12||1.28|0.40|0.263
71000986|NCT03906136|141508610|SUPERIORITY||Odds Ratio (OR)|0.61||||0.103|TWO_SIDED|95.0|0.34|1.1|||Regression, Logistic|||Week 24||1.10|0.34|0.103
71000987|NCT03906136|141508611|SUPERIORITY||Odds Ratio (OR)|0.64||||0.055|TWO_SIDED|95.0|0.4|1.01|||Regression, Logistic|||Week 12||1.01|0.40|0.055
71000988|NCT03906136|141508611|SUPERIORITY||Odds Ratio (OR)|0.82||||0.409|TWO_SIDED|95.0|0.52|1.31|||Regression, Logistic|||Week 24||1.31|0.52|0.409
71000989|NCT03906136|141508612|SUPERIORITY||Odds Ratio (OR)|0.85||||0.477|TWO_SIDED|95.0|0.53|1.34|||Regression, Logistic|||Week 12||1.34|0.53|0.477
71000990|NCT03906136|141508612|SUPERIORITY||Odds Ratio (OR)|1.01||||0.968|TWO_SIDED|95.0|0.63|1.61|||Regression, Logistic|||Week 24||1.61|0.63|0.968
71000991|NCT03906136|141508613|SUPERIORITY||Odds Ratio (OR)|0.3||||0.205|TWO_SIDED|95.0|-0.16|0.75|||Regression, Logistic|||Week 12||0.75|-0.16|0.205
71000992|NCT03906136|141508613|SUPERIORITY||Odds Ratio (OR)|0.37||||0.108|TWO_SIDED|95.0|-0.08|0.82|||Regression, Logistic|||Week 24||0.82|-0.08|0.108
71000993|NCT03906136|141508614|SUPERIORITY||Mean Difference (Net)|0.06||||0.525|TWO_SIDED|95.0|-0.12|0.23|||Mixed Models Analysis|||Week 12||0.23|-0.12|0.525
71000994|NCT03906136|141508614|SUPERIORITY||Mean Difference (Net)|-0.06||||0.577|TWO_SIDED|95.0|-0.25|0.14|||Mixed Models Analysis|||Week 24||0.14|-0.25|0.577
71000995|NCT03906136|141508615|SUPERIORITY||Odds Ratio (OR)|-0.89||||0.22|TWO_SIDED|95.0|-2.32|0.54|||Mixed Models Analysis|||Week 12||0.54|-2.32|0.220
71042286|NCT00292227|141594014|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.84||||||90.0|-1.12|2.8|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.80|-1.12|
71000996|NCT03906136|141508615|SUPERIORITY||Median Difference (Net)|-0.1||||0.745|TWO_SIDED|95.0|-0.7|0.5|||Regression, Logistic|||Week 24||0.50|-0.70|0.745
71000997|NCT03906136|141508616|SUPERIORITY||Mean Difference (Net)|-0.13||||0.768|TWO_SIDED|95.0|-1.01|0.74|||Mixed Models Analysis|||Week 12||0.74|-1.01|0.768
71000998|NCT03906136|141508616|SUPERIORITY||Mean Difference (Net)|-0.37||||0.451|TWO_SIDED|95.0|-1.34|0.6|||Mixed Models Analysis|||Week 24||0.60|-1.34|0.451
71000999|NCT03906136|141508617|SUPERIORITY||Mean Difference (Net)|0.26||||0.477|TWO_SIDED|95.0|-0.46|0.97|||Mixed Models Analysis|||Week 12||0.97|-0.46|0.477
71001000|NCT03906136|141508617|SUPERIORITY||Mean Difference (Net)|-0.17||||0.66|TWO_SIDED|95.0|-0.92|0.58|||Mixed Models Analysis|||Week 24||0.58|-0.92|0.660
71001001|NCT03906136|141508618|SUPERIORITY||Mean Difference (Net)|0.17||||0.586|TWO_SIDED|95.0|-0.45|0.79|||Mixed Models Analysis|||Week 12||0.79|-0.45|0.586
71001002|NCT03906136|141508618|SUPERIORITY||Median Difference (Net)|0.21||||0.491|TWO_SIDED|95.0|-0.39|0.82|||Mixed Models Analysis|||Week 24||0.82|-0.39|0.491
71001003|NCT03906136|141508619|SUPERIORITY|Week 12|Mean Difference (Net)|4.49||||0.082|TWO_SIDED|95.0|-0.58|9.56|||Mixed Models Analysis|||||9.56|-0.58|0.082
71001004|NCT03906136|141508619|SUPERIORITY||Median Difference (Net)|2.73||||0.292|TWO_SIDED|95.0|-2.35|7.81|||Mixed Models Analysis|||Week 24||7.81|-2.35|0.292
71001005|NCT00323310|141508620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_DEVIATION|1.46|<|0.0001|TWO_SIDED|95.0|1.1|1.5||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.5|1.1|<0.0001
71001006|NCT00323310|141508621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_DEVIATION|1.45|<|0.0001|TWO_SIDED|95.0|0.9|1.4||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.4|0.9|<0.0001
71001007|NCT00323310|141508622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_DEVIATION|1.42|<|0.0001|TWO_SIDED|95.0|0.4|0.9||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||0.9|0.4|<0.0001
71001008|NCT00323310|141508623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_DEVIATION|1.56|<|0.001|TWO_SIDED|95.0|1.1|1.6||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.6|1.1|<0.001
71001009|NCT00323310|141508624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|STANDARD_DEVIATION|1.49|<|0.001|TWO_SIDED|95.0|0.8|1.4||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.4|0.8|<0.001
71001010|NCT00323310|141508625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_DEVIATION|1.2|<|0.0001|TWO_SIDED|95.0|0.4|0.8||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||0.8|0.4|<0.0001
71001011|NCT00323310|141508626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_DEVIATION|1.57|<|0.0001|TWO_SIDED|95.0|1.0|1.5||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.5|1.0|<0.0001
71001012|NCT00323310|141508627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_DEVIATION|1.49|<|0.0001|TWO_SIDED|95.0|0.9|1.4||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.4|0.9|<0.0001
71001013|NCT00323310|141508628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_DEVIATION|1.54|<|0.0001|TWO_SIDED|95.0|0.6|1.1||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.1|0.6|<0.0001
71001014|NCT00446641|141508630|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.654||95.0|||||Chi-squared|||We assumed that the prevalence of AR would be 12 % among ischemic stroke patients who were treated with aspirin 100 per day. The prevalence could be reduced to 4% with additional cilostazol therapy||||0.654
71001015|NCT05302804|141508673|SUPERIORITY|||||||0.742||||||p-value reflects main effect of treatment.|ANOVA|||"Null hypothesis was there was no difference between menthol gel and control gel~time x trial ANOVA statistical analysis"||||0.742
71001016|NCT05302804|141508674|SUPERIORITY|||||||0.742||||||p-value is main effect of menthol|ANOVA|||The null hypothesis is that there is no difference between menthol and control trials||||0.742
70924164|NCT02814838|141340510|SUPERIORITY||Adjusted mean difference|0.1639||||0.6299|TWO_SIDED|95.0|-0.5202|0.8479|||Mixed Models Analysis|||Week 52 Analysis is based on a linear mixed model for repeated measures with log(AUC(15-120 minutes)+1) of C-peptide above fasting value as dependent variable, treatment, visit and treatment by visit interaction||0.8479|-0.5202|0.6299
70924165|NCT02814838|141340511|SUPERIORITY|||||||0.163|||||||Fisher Exact|||Week 13||||0.163
70924166|NCT02814838|141340511|SUPERIORITY|||||||0.0074|||||||Fisher Exact|||Week 26||||0.0074
71100664|NCT02732145|141709683|SUPERIORITY|Question: Is there a difference in the frequency of smoothness of the Middle Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71100665|NCT02732145|141709683|SUPERIORITY|Question: Is there a difference in the incidence of smoothness of the Inner Vulvar Ring between patients within different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
70924167|NCT02814838|141340511|SUPERIORITY|||||||0.4437|||||||Fisher Exact|||Week 52||||0.4437
70924168|NCT03811366|141340512|OTHER||||||<|0.001||||||significance when p\<0;05|generalized estimated equation|generalized estimated equation with normal distribution and logarithmic link function||||||<0.001
71001017|NCT05302804|141508675|SUPERIORITY|||||||0.048||||||p-value reflects main effect of menthol|ANOVA|||The null hypothesis is that there is no difference between menthol and control trials||||0.048
71001018|NCT05302804|141508676|SUPERIORITY|||||||0.104|||||||t-test, 2 sided|||The null hypothesis is that there is no difference between menthol and control trials||||.104
71100666|NCT02732145|141709683|SUPERIORITY|Question: Is there a difference in the incidence of ischemia of the Middle Vulvar Ring between patients from different groups?||||||0.0632|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0632
71100667|NCT02732145|141709683|SUPERIORITY|Question: Is there a difference in the incidence of ischemia of the Inner Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71100668|NCT02732145|141709683|SUPERIORITY|Question: Is there a difference in the incidence of punctuation of the Middle Vulvar Ring between patients within different groups?||||||0.0043|||||||Chi-squared|||"Parameter: The incidence of punctuation of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0043
71100669|NCT02732145|141709683|SUPERIORITY|Question: Is there a difference in the incidence of punctuation of the Inner Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of punctuation of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Typ), evaluated with Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71100670|NCT02732145|141709683|SUPERIORITY|Question: Is there a difference in the incidence of papillae of the Inner Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of papillae of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
70924169|NCT03811366|141340515|OTHER|||||||0.054||||||significance when p\<0.05|Fisher Exact|||Recurrence or worsening of cells in anterior chamber in ERG-stable and ERG worsening group.||||0.054
70924170|NCT03811366|141340516|OTHER|||||||0.478||||||17 eyes presented dark dots fluctuation during follow up in stable ERG group when compared to 5 eyes in worsening ERG group.|generalized estimated equation|Generalized estimated equation with Poisson distribution and identity link function supposing an interchangeable correlation matrix between the eyes||||||0.478
71001019|NCT05302804|141508677|SUPERIORITY|||||||0.051|||||||t-test, 2 sided|||The null hypothesis is that there is no difference between menthol and control trials||||.051
71042287|NCT00292227|141594015|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.26||||||90.0|-1.8|2.32|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.32|-1.80|
71042288|NCT00292227|141594016|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.11||||||90.0|-2.25|2.02|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.02|-2.25|
71042289|NCT00292227|141594017|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.07||||||90.0|-2.14|2.28|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.28|-2.14|
71042290|NCT00292227|141594018|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.56||||||90.0|-2.84|1.72|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.72|-2.84|
71042291|NCT00292227|141594019|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.26||||||90.0|-2.29|1.78|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.78|-2.29|
71042292|NCT00292227|141594020|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-1.17||||||90.0|-3.25|0.91|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||0.91|-3.25|
71042293|NCT00292227|141594021|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|1.69||||||90.0|-0.34|3.73|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||3.73|-0.34|
71042294|NCT00292227|141594022|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.31||||||90.0|-1.7|2.32|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.32|-1.70|
71042295|NCT00292227|141594023|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|1.65||||||90.0|-0.65|3.96|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||3.96|-0.65|
71100671|NCT02732145|141709683|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with vulvar dermatosis?||||||0.0697|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with vulvar dermatosis.||||0.0697
71100672|NCT02732145|141709683|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis?||||||0.0319|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis.||||0.0319
71100673|NCT02732145|141709683|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Middle versus non-specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis?||||||0.7273|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Middle versus non-specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis.||||0.7273
71100674|NCT02732145|141709683|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
71100675|NCT02732145|141709683|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Inner Vulvar Ring in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
71100676|NCT02732145|141709683|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Middle versus non-specific lesions of the Inner Vulvar Ring in patients with vulvodynia?||||||0.2203|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Middle versus non-specific lesions of the Inner Vulvar Ring in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.2203
70924171|NCT03811366|141340518|OTHER|9 (52.9%) eyes in ERG stable group x 4 (57.1%)eyes presented change in perivascular leakage during follow up (p=0.936).||||||0.936|||||||Generalized estimated equation|Generalized estimated equation with binomial distribution and logit link function, supposing an interchangeable correlation matrix between the eyes;||Change in perivascular leakage in ERG-stable and ERG- worsening groups.||||0.936
70924172|NCT03811366|141340519|OTHER|||||||0.853||||||significance when p\<0.05|Generalized estimated equation|Generalized estimated equation with binomial distribution and logit link function, supposing an interchangeable correlation matrix between the eyes;||||||0.853
70924173|NCT03811366|141340520|OTHER|||||||0.272||||||significance when p\<0.05|Fisher Exact|||||||0.272
70924174|NCT03811366|141340521|OTHER|||||||0.983||||||significance when p\<0.05|Generalized estimated equation with bino|Generalized estimated equation with binomial distribution and logit link function, supposing an interchangeable correlation matrix between the eyes||||||0.983
71100677|NCT02732145|141709683|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Outer versus non-specific lesions of the Middle Vulvar Ring in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with impaired vulvar skin.||||0.0000
71100678|NCT02732145|141709683|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Outer versus non-specific lesions of the Inner Vulvar Ring in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Inner Vulvar Ring in patients with impaired vulvar skin.||||0.0000
71100679|NCT02732145|141709683|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Middle versus non-specific lesions of the Inner Vulvar Ring in patients with impaired vulvar skin?||||||0.1456|||||||t-test proportion|||Parameter: The incidence of non-specific lesions of the Middle versus non-specific lesions of the Inner Vulvar Ring in patients with impaired vulvar skin.||||0.1456
70924175|NCT02596126|141340527|NON_INFERIORITY|"Non-inferiority hypothesis will be tested using a univariable Cox PH regression model including treatment group as the only covariate and stratified by country.~One-sided non-inferiority test on the primary endpoint where the alpha level will be set to 2.5%.~All statistical analyses will use 95% confidence intervals (CI). If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a log-rank test."|Hazard Ratio (HR)|0.76|||<|0.025|TWO_SIDED|95.0|0.6|0.96|||Regression, Cox|||||0.96|0.6|< 0.025
70924176|NCT02596126|141340527|SUPERIORITY|If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a logrank test.|||||<|0.05|||||||Log Rank|||||||< 0.05
71100680|NCT02732145|141709683|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Outer versus specific lesions of the Middle Vulvar Ring in patients with vulvar dermatosis?||||||0.1133|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Outer versus specific lesions of the Middle Vulvar Ring in patients with vulvar dermatosis.||||0.1133
71100681|NCT02732145|141709683|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Outer versus specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Outer versus specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis.||||0.0000
71042296|NCT00292227|141594024|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.21||||||90.0|-1.78|1.36|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.36|-1.78|
71042297|NCT00292227|141594025|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.53||||||90.0|-2.37|1.3|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.30|-2.37|
71042298|NCT00292227|141594026|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.41||||||90.0|-2.3|1.49|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.49|-2.30|
71042299|NCT00292227|141594027|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.5||||||90.0|-2.34|1.35|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.35|-2.34|
71042300|NCT00292227|141594028|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.21||||||90.0|-1.76|2.17|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.17|-1.76|
71042301|NCT00292227|141594029|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-1.23||||||90.0|-2.99|0.53|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||0.53|-2.99|
71042302|NCT00292227|141594030|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-1.62||||||90.0|-3.87|0.63|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||0.63|-3.87|
71042303|NCT00292227|141594031|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.81||||||90.0|-2.55|0.93|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||0.93|-2.55|
70924177|NCT02596126|141340528|EQUIVALENCE|Treatment adherence is measured at visit 1 (6 months) and visit 3 (24 months) using the Morisky-Medication Adherence Scale (8 item) Questionnaire (MMAS-8). The number and percentage of patients with low (0-5), medium (6-7) and high (8) adherence will be reported by treatment group. The distributions of the MMAS-8 score at 6 months and 24 months will be compared between treatment groups using an ordinal logistic regression model.|Risk Ratio (RR)|1.13|||<|0.005|TWO_SIDED|95.0|1.06|1.2|||Chi-squared|||Statistical analysis title - Treatment adherence at 6 months||1.2|1.06|< 0.005
70924178|NCT02596126|141340529|SUPERIORITY|Time to first event will be investigated using Cox proportional hazards regression. Hazard ratios and 95% confidence intervals will be obtained from the Cox proportional hazards model. P-values will be obtained using the log-rank test.|Hazard Ratio (HR)|0.97|||<|0.05|TWO_SIDED|95.0|0.75|1.25|||Log Rank|||Statistical analysis title - All-cause death||1.25|0.75|< 0.05
70924179|NCT02596126|141340530|EQUIVALENCE|Treatment adherence is measured at visit 1 (6 months) and visit 3 (24 months) using the Morisky- Medication Adherence Scale (8 item) Questionnaire (MMAS-8). The number and percentage of patients with low (0-5), medium (6-7) and high(8) adherence will be reported by treatment group. The distributions of the MMAS-8 score at 6 months and 24 months will be compared between treatment groups using an ordinal logistic regression model.|Hazard Ratio (HR)|1.17|||<|0.005|TWO_SIDED|95.0|1.1|1.25|||Chi-squared|||Statistical analysis title - Treatment adherence at 24 months||1.25|1.1|< 0.005
70924180|NCT02596126|141340531|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|-0.3|||<|0.05|TWO_SIDED|95.0|-1.8|1.2||The difference in mean change from baseline between groups will be compared using ANCOVA (adjusting for baseline levels) at 6 months, 12 months and 24 months. The difference in mean change adjusting for baseline and 95% CI will be reported.|ANCOVA|||Statistical analysis title - SBP - 6 months||1.2|-1.8|< 0.05
70924181|NCT02596126|141340532|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|1.4|||<|0.05|TWO_SIDED|95.0|-0.1|3.0||The difference in mean change from baseline between groups will be compared using ANCOVA (adjusting for baseline levels) at 6 months, 12 months and 24 months. The difference in mean change adjusting for baseline and 95% CI will be reported.|ANCOVA|||Statistical analysis title - SBP - 12 months||3|-0.1|< 0.05
70924182|NCT02596126|141340533|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|-0.1|||<|0.05|TWO_SIDED|95.0|-1.7|1.4||The difference in mean change from baseline between groups will be compared using ANCOVA (adjusting for baseline levels) at 6 months, 12 months and 24 months. The difference in mean change adjusting for baseline and 95% CI will be reported.|ANCOVA|||Statistical analysis title - SBP - 24 months||1.4|-1.7|< 0.05
71001020|NCT05302804|141508678|SUPERIORITY||||||<|0.001||||||Main effect of treatment|ANOVA|||The null hypothesis is that there is no difference between menthol and control trials||||< 0.001
71001021|NCT05302804|141508679|SUPERIORITY|||||||0.026|||||||ANOVA|||The null hypothesis is that there is no difference between menthol and control trials||||.026
71001022|NCT05302804|141508680|SUPERIORITY|||||||0.001||||||p-value at time 30 min of exercise|ANOVA|||The null hypothesis is that there is no difference between menthol and control trials||||.001
71001023|NCT05302804|141508681|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71001024|NCT03250624|141508701|SUPERIORITY||Least Square (LS) Mean Difference|-0.28||||0.632|TWO_SIDED|95.0|-1.46|0.89|||ANCOVA|||||0.89|-1.46|0.632
71001025|NCT03012594|141508747|SUPERIORITY|||||||0.07|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.07
71001026|NCT01263314|141508879|OTHER||Mean Difference (Final Values)|-1.25||||0.3551|TWO_SIDED|90.0|-7.01|4.5|||ANOVA|||||4.50|-7.01|0.3551
71001027|NCT01263314|141508879|OTHER||Mean Difference (Final Values)|-1.32||||0.3474|TWO_SIDED|90.0|-7.08|4.48|||ANOVA|||||4.48|-7.08|0.3474
71001028|NCT01263314|141508879|OTHER||Mean Difference (Final Values)|-1.67||||0.3105|TWO_SIDED|90.0|-7.42|4.09|||ANOVA|||||4.09|-7.42|0.3105
71001029|NCT01263314|141508879|OTHER||Mean Difference (Final Values)|-6.25||||0.1346|TWO_SIDED|90.0|-15.8|3.27|||ANOVA|||||3.27|-15.8|0.1346
71001030|NCT01263314|141508879|OTHER||Mean Difference (Final Values)|-10.1||||0.0416|TWO_SIDED|90.0|-19.6|-0.56|||ANOVA|||||-0.56|-19.6|0.0416
71001031|NCT01263314|141508879|OTHER||Mean Difference (Final Values)|-8.2||||0.0762|TWO_SIDED|90.0|-17.7|1.32|||ANOVA|||||1.32|-17.7|0.0762
71001032|NCT01263314|141508880|OTHER||Mean Difference (Final Values)|0.47||||0.418|TWO_SIDED|90.0|-3.47|4.41|||ANOVA|||||4.41|-3.47|0.418
71001033|NCT01263314|141508880|OTHER||Mean Difference (Final Values)|4.12||||0.0434|TWO_SIDED|90.0|0.18|8.05|||ANOVA|||||8.05|0.18|0.0434
71001034|NCT01263314|141508880|OTHER||Mean Difference (Final Values)|7.79||||0.0019|TWO_SIDED|90.0|3.85|11.72|||ANOVA|||||11.72|3.85|0.0019
71001035|NCT01263314|141508880|OTHER||Mean Difference (Final Values)|1.15||||0.2223|TWO_SIDED|90.0|-1.42|3.71|||ANOVA|||||3.71|-1.42|0.2223
71001036|NCT01263314|141508880|OTHER||Mean Difference (Final Values)|4.25||||0.0056|TWO_SIDED|90.0|1.69|6.82|||ANOVA|||||6.82|1.69|0.0056
71001037|NCT01263314|141508880|OTHER||Mean Difference (Final Values)|5.4||||0.0012|TWO_SIDED|90.0|2.83|7.96|||ANOVA|||||7.96|2.83|0.0012
71001038|NCT01263314|141508882|OTHER||GMR (Elderly female/Elderly male)|1.23|||||TWO_SIDED|90.0|0.85|1.76|||||GMR = geometric mean ratio|||1.76|0.85|
71001039|NCT01263314|141508883|OTHER||GMR (Elderly female/Elderly male)|1.08|||||TWO_SIDED|90.0|0.88|1.33||||||||1.33|0.88|
71001040|NCT01263314|141508883|OTHER||GMR (Elderly female/Elderly male)|1.26|||||TWO_SIDED|90.0|1.02|1.55||||||||1.55|1.02|
71001041|NCT01263314|141508883|OTHER||GMR (Elderly female/Elderly male)|1.2|||||TWO_SIDED|90.0|0.98|1.48||||||||1.48|0.98|
71001042|NCT01263314|141508886|SUPERIORITY||MK-8266 0.3 mg vs. placebo|9.58||||0.0253|TWO_SIDED|90.0|1.69|17.46|||ANOVA|||||17.46|1.69|0.0253
71001043|NCT01263314|141508886|SUPERIORITY||MK-8266 0.6 mg vs. placebo|-2.59||||0.2856|TWO_SIDED|90.0|-10.5|5.29|||ANOVA|||||5.29|-10.5|0.2856
71001044|NCT01263314|141508886|SUPERIORITY||MK-8266 0.7 mg/ 0.3 mg vs. placebo|-4.06||||0.1895|TWO_SIDED|90.0|-11.9|3.82|||ANOVA|||||3.82|-11.9|0.1895
71001045|NCT01263314|141508886|SUPERIORITY||MK-8266 0.3 mg vs. placebo|-4.16||||0.1157|TWO_SIDED|90.0|-10.0|1.7|||ANOVA|||||1.70|-10.0|0.1157
71001046|NCT01263314|141508886|SUPERIORITY||MK-8266 0.6 mg vs. placebo|-11.7||||0.0018|TWO_SIDED|90.0|-17.5|-5.79|||ANOVA|||||-5.79|-17.5|0.0018
71001047|NCT01263314|141508886|SUPERIORITY||MK-8266 0.7 mg/ 0.3 mg vs. placebo|-10.6||||0.0034|TWO_SIDED|90.0|-16.5|-4.77|||ANOVA|||||-4.77|-16.5|0.0034
71001048|NCT00282568|141508890|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of the natural log-transformed pharmacokinetic parameters fell within an 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|94.97|||||TWO_SIDED|90.0|90.72|99.41|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance with repeated measures was used for the comparisons of AUC0-24. Exposure at steady state was used for tacrolimus (steady state was defined as days 1 and 7) and for tacrolimus MR (steady state was defined as days 14 and 21). The natural log (ln) was used to transform AUC0-24 prior to analysis and the results were transformed back to the original scale for the presentation of results.||99.41|90.72|
71001049|NCT00282568|141508892|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of the natural log-transformed pharmacokinetic parameters fell within an 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|88.15|||||TWO_SIDED|90.0|82.69|93.96|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance with repeated measures was used for the comparisons of Cmax. Exposure at steady state was used for tacrolimus (steady state was defined as days 1 and 7) and for tacrolimus MR (steady state was defined as days 14 and 21). The natural log (ln) was used to transform Cmax prior to analysis and the results were transformed back to the original scale for the presentation of results.||93.96|82.69|
71001050|NCT00282568|141508893|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of the natural log-transformed pharmacokinetic parameters fell within an 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|87.2|||||TWO_SIDED|90.0|82.72|91.93|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance with repeated measures was used for the comparisons of Cmin. Exposure at steady state was used for tacrolimus (steady state was defined as days 1 and 7) and for tacrolimus MR (steady state was defined as days 14 and 21). The natural log (ln) was used to transform Cmin prior to analysis and the results were transformed back to the original scale for the presentation of results.||91.93|82.72|
71001051|NCT03689972|141508945|SUPERIORITY||Ratio of Mean|4.24|||=|0.0755|TWO_SIDED|95.0|0.86|20.85|||Negative Binomial Regression|The model included treatment as classification variable \& baseline body weight, duration of natalizumab exposure at baseline, \& region as covariates.||||20.85|0.86|=0.0755
71100682|NCT02732145|141709683|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Middle versus specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis?||||||0.0058|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Middle versus specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis.||||0.0058
71001052|NCT03689972|141508946|SUPERIORITY||Percentage|87.8|||||TWO_SIDED|95.0|80.68|93.01|||Exact Binomial method|Percentage of participants preferring natalizumab SC at end of crossover period of Part 2, and 95% CI was calculated using the exact binomial method.||||93.01|80.68|
71001053|NCT03689972|141508948|SUPERIORITY||Ratio of annualized relapse rate|1.32481|||=|0.6312|TWO_SIDED|95.0|0.42016|4.17725|||Poisson Regression|Poisson regression model was adjusted for baseline body weight, duration of natalizumab exposure at baseline, and region.||||4.17725|0.42016|=0.6312
71001054|NCT03689972|141508954|SUPERIORITY||Difference|0.47|||=|0.764|TWO_SIDED|95.0|-2.61|3.54||Performed with factors:route of administration,period,sequence,body weight,duration of natalizumab exposure,stratification factor,baseline TSQM score.|Linear Mixed Effects Model|||||3.54|-2.61|=0.764
71001055|NCT03689972|141508961|SUPERIORITY||Difference|0.08|||=|0.357|TWO_SIDED|95.0|-0.09|0.25||Performed with factors:route of administration,period,sequence,body weight,duration of natalizumab exposure,stratification factor,baseline TSQM score.|Linear Mixed Effects Model|||||0.25|-0.09|=0.357
71001056|NCT00324272|141508971|SUPERIORITY_OR_OTHER|||||||0.704||95.0|||||t-test, 2 sided|||||||0.704
71001057|NCT00324272|141508971|SUPERIORITY_OR_OTHER|||||||0.217||95.0|||||t-test, 2 sided|||||||0.217
71001058|NCT00324272|141508973|SUPERIORITY_OR_OTHER|||||||0.988||95.0|||||t-test, 2 sided|||||||0.988
71001059|NCT00324272|141508973|SUPERIORITY_OR_OTHER|||||||0.426||95.0|||||t-test, 2 sided|||||||0.426
71001060|NCT00324272|141508974|SUPERIORITY_OR_OTHER|||||||0.351||95.0|||||Fisher Exact|||||||0.351
71001061|NCT00324272|141508974|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Fisher Exact|||||||0.480
71001062|NCT00324272|141508975|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
71001063|NCT00324272|141508975|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.400
71001064|NCT00324272|141508976|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Local recurrence in the groin cohort.||||1.00
71001065|NCT00324272|141508976|SUPERIORITY_OR_OTHER|||||||0.301||95.0|||||Fisher Exact|||In transit or regional recurrence in the groin cohort.||||0.301
71001066|NCT00324272|141508976|SUPERIORITY_OR_OTHER|||||||0.474||95.0|||||Fisher Exact|||Distant metastasis in the groin cohort (with the patient being alive at the end of the study follow-up period on 1.6.10).||||0.474
71001067|NCT00324272|141508976|SUPERIORITY_OR_OTHER|||||||0.606||95.0|||||Fisher Exact|||Local recurrence in the groin cohort.||||0.606
71001068|NCT00324272|141508976|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||In transit or regional recurrence in the axillary cohort.||||1.000
71001069|NCT00324272|141508976|SUPERIORITY_OR_OTHER|||||||0.486||95.0|||||Fisher Exact|||Distant metastasis in the axillary cohort (with the patient being alive at the end of the study follow-up period on 1.6.10).||||0.486
70924183|NCT02596126|141340534|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|0.2|||<|0.05|TWO_SIDED|95.0|-0.7|1.0||The difference in mean change from baseline between groups will be compared using ANCOVA (adjusting for baseline levels) at 6 months, 12 months and 24 months. The difference in mean change adjusting for baseline and 95% CI will be reported.|ANCOVA|||Statistical analysis title - DBP - 6 months||1|-0.7|< 0.05
70924184|NCT02596126|141340535|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|0.8|||<|0.05|TWO_SIDED|95.0|-0.1|1.6||The difference in mean change from baseline between groups will be compared using ANCOVA (adjusting for baseline levels) at 6 months, 12 months and 24 months. The difference in mean change adjusting for baseline and 95% CI will be reported.|ANCOVA|||Statistical analysis title - DBP - 12 months||1.6|-0.1|< 0.05
70924185|NCT02596126|141340536|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|0.0|||<|0.05|TWO_SIDED|95.0|-0.9|1.0||The difference in mean change from baseline between groups will be compared using ANCOVA (adjusting for baseline levels) at 6 months, 12 months and 24 months. The difference in mean change adjusting for baseline and 95% CI will be reported.|ANCOVA|||Statistical analysis title - DBP - 24 months||1|-0.9|< 0.05
70924186|NCT02596126|141340537|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|2.1|||<|0.05|TWO_SIDED|95.0|-0.2|4.4|||ANCOVA|||Statistical analysis title - LDL cholesterol - 12 months||4.4|-0.2|< 0.05
71001070|NCT00324272|141508977|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.963|TWO_SIDED|95.0|0.4|2.58|||Regression, Cox|||Death from metastatic disease in the groin cohort.||2.58|0.40|0.963
71001071|NCT00324272|141508977|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.338|TWO_SIDED|95.0|0.03|3.2|||Regression, Cox|||Death from an unrelated cause in the groin cohort.||3.20|0.03|0.338
71001072|NCT00324272|141508977|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.88|TWO_SIDED|95.0|0.35|2.47|||Regression, Cox|||Death from metastatic disease in the axillary cohort.||2.47|0.35|0.880
71001073|NCT00324272|141508977|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.923||||0.923|TWO_SIDED|95.0|0.05|13.95|||Regression, Cox|||Death from an unrelated cause in the axillary cohort.||13.95|0.05|0.923
71001074|NCT02417064|141508978|SUPERIORITY||Difference of Least Square (LS) Means|-3.2||||0.088|TWO_SIDED|95.0|-6.88|0.45|||Mixed Model for Repeated Measures|||||0.45|-6.88|0.088
71001075|NCT02417064|141508978|SUPERIORITY||Difference of Least Square (LS) Means|-4.1|||||TWO_SIDED|95.0|-7.67|-0.49||||||||-0.49|-7.67|
71001076|NCT02417064|141508979|SUPERIORITY||Difference of Least Square (LS) Means|-2.0|||=|0.25|TWO_SIDED|95.0|-5.52|1.42|||ANCOVA|||||1.42|-5.52|= 0.250
71001077|NCT02417064|141508979|SUPERIORITY||Difference of Least Square (LS) Means|-4.1|||||TWO_SIDED|95.0|-7.53|-0.6||||||||-0.6|-7.53|
71001078|NCT00371540|141508994|SUPERIORITY_OR_OTHER|||||||0.65|||||||Fisher Exact|||Note: The differences between the number of individuals evaluable for this secondary outcome and the number of individuals evaluable for the primary outcome is related to specimen loss by the laboratory. As such of the Routine care group only 96 of 102 patients completing the study were evaluable for the viral load outcome and only 86 of 87 patients in the Home visit group.||||0.65
71001079|NCT00371540|141508995|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
71042304|NCT00292227|141594032|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.37||||||90.0|-2.13|1.39|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.39|-2.13|
71001080|NCT00371540|141508996|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Fisher Exact|||||||<0.05
71001081|NCT01548417|141508998|SUPERIORITY_OR_OTHER|||||||0.003|||||||Mixed Models Analysis|||Linear Mixed Effects Modeling (MEM) with Restricted Maximum Likelihood estimation was used to measure differences in alcohol-cued craving..||||.003
71001082|NCT01548417|141508999|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||Linear Mixed Effect Modeling (MEM) with Restricted Maximum Likelihood estimation was used to measure differences in changes in drinking.||||.05
71001083|NCT01548417|141508999|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||Data represent the estimated marginal mean + or - SEM. \*P\<0.05, mifepristone vs. placebo (linear mixed effects modeling).||||<0.05
71001084|NCT04583969|141509000|SUPERIORITY||Odds Ratio (OR)|1.13||||0.691|TWO_SIDED|95.0|0.63|2.02|||Regression, Logistic||Odds ratio above 1 favors Remdesivir plus Lenzilumab.|Odds ratio, CI, and p-value estimated from a logistic regression model adjusted for baseline dexamethasone use, baseline OS, age (continuous), and baseline CRP. Missing data imputed using the 3-stage multiple imputation procedure described in the statistical analysis plan.||2.02|0.63|0.691
71100683|NCT02732145|141709684|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Mons pubis in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
71100684|NCT02732145|141709684|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Majora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Labia Majora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
71001085|NCT04583969|141509001|SUPERIORITY||Odds Ratio (OR)|1.24||||0.378|TWO_SIDED|95.0|0.77|1.99|||Regression, Logistic||Odds ratio above 1 favors Remdesivir plus Lenzilumab.|Odds ratio, CI, and p-value estimated from a logistic regression model adjusted for baseline dexamethasone use, baseline OS, age (continuous), and baseline CRP. Missing data imputed using the 3-stage multiple imputation procedure described in the statistical analysis plan.||1.99|0.77|0.378
71001086|NCT04583969|141509002|SUPERIORITY|Hazard ratio, confidence intervals, and p-value estimated from a Cox model adjusted for baseline dexamethasone use, baseline ordinal score, age, and baseline CRP.|Hazard Ratio, log|0.96||||0.689|TWO_SIDED|95.0|0.76|1.2|||Regression, Cox||HR greater than 1 favors Remdesivir plus Lenzilumab.|||1.20|0.76|0.689
71001087|NCT04583969|141509003|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.718|TWO_SIDED|95.0|0.79|1.18|||Regression, Cox||HR greater than 1 favors Remdesivir plus Lenzilumab.|Hazard ratio, confidence intervals, and p-value estimated from a Cox model adjusted for baseline dexamethasone use, baseline ordinal Score, age, and baseline CRP.||1.18|0.79|0.718
71100685|NCT02732145|141709684|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Perineum among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Perineum in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
71100686|NCT02732145|141709684|SUPERIORITY|Question: Is there a difference in the incidence of erythema of Mons Pubis among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Mons Pubis in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
71100687|NCT02732145|141709684|SUPERIORITY|Question: Is there a difference in the incidence of erythema of Labia Majora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Labia Majora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
71100688|NCT02732145|141709684|SUPERIORITY|Question: Is there a difference in the incidence of erythema of the Perineum among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Perineum in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
71100689|NCT02732145|141709684|SUPERIORITY|Question: Is there a difference in the incidence of excoriations of Mons Pubis among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of excoriations of Mons Pubis in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
71100690|NCT02732145|141709684|SUPERIORITY|Question: Is there a difference in the incidence of excoriations of Labia Majora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of excoriations of Labia Majora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
71100691|NCT02732145|141709684|SUPERIORITY|Question: Is there a difference in the incidence of excoriations of the Perineum among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of excoriations of the Perineum in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
71100692|NCT02732145|141709684|SUPERIORITY|Question: Is there a difference in the incidence of rhagades of Mons Pubis among patients from different groups?||||||0.0016|||||||Chi-squared|||"Parameter: The incidence of rhagades of Mons Pubis in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0016
71008609|NCT02055976|141525232|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-55.489|STANDARD_ERROR_OF_MEAN|3.496|<|0.001|TWO_SIDED|95.0|-62.436|-48.542|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-48.542|-62.436|<0.001
71008610|NCT02055976|141525232|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-35.288|STANDARD_ERROR_OF_MEAN|3.41|<|0.001|TWO_SIDED|95.0|-42.059|-28.516|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-28.516|-42.059|<0.001
70924187|NCT02596126|141340538|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|-0.1|||<|0.05|TWO_SIDED|95.0|-2.5|2.4|||ANCOVA|||Statistical analysis title - LDL cholesterol - 24 months||2.4|-2.5|< 0.05
71001088|NCT04583969|141509004|SUPERIORITY||Odds Ratio (OR)|1.02||||0.907|TWO_SIDED|95.0|0.75|1.39|||Proportional odds model||Odds ratio greater than 1 favors Remdesivir plus Lenzilumab.|Includes all ordinal score categories. Odds ratio of a better clinical status score, confidence interval and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using multiple imputation (MI) for participants lost to follow-up before Day 8 while hospitalized, in hospice, long term acute care, or transferred to other hospital while those participants lost to follow-up after discharge to home are assigned a score of 2.||1.39|0.75|0.907
71001089|NCT04583969|141509038|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.609|TWO_SIDED|95.0|0.87|1.27|||Regression, Cox||HR greater than 1 favors Remdesivir plus Lenzilumab|||1.27|0.87|0.609
71001090|NCT04583969|141509039|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.708|TWO_SIDED|95.0|0.85|1.26|||Regression, Cox||HR greater than 1 favors Remdesivir plus Lenzilumab|||1.26|0.85|0.708
71042305|NCT00292227|141594033|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.68||||||90.0|-2.6|1.25|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.25|-2.60|
71042306|NCT00292227|141594034|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|1.17||||||90.0|-0.69|3.03|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||3.03|-0.69|
71042307|NCT00292227|141594035|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.8||||||90.0|-1.14|2.73|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.73|-1.14|
71042308|NCT00292227|141594036|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.42||||||90.0|-2.33|1.5|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.50|-2.33|
71042309|NCT00292227|141594037|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.34||||||95.0|-1.04|1.71|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||1.71|-1.04|
71042310|NCT00292227|141594038|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.48||||||95.0|-0.72|1.68|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||1.68|-0.72|
71042311|NCT00292227|141594039|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.51||||||95.0|0.3|2.73|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||2.73|0.30|
71100693|NCT02732145|141709684|SUPERIORITY|Question: Is there a difference in the incidence of rhagades of Labia Majora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of rhagades of Labia Majora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
71001091|NCT01057862|141509041|OTHER|We are including the mean and SD of each arm at the start and end of study only as a comparison and not a meaningful analysis. Since higher scores represent a more severe form of the disorder, a drop in scores is seen as an indicator that the treatment had an effect.|Mean Difference (Final Values)|6.0|STANDARD_DEVIATION|9.35|||TWO_SIDED||||||||The active arm had a mean PG-YBOCS score of 16 (n=5) at study start with a SD of 7.35. At end of study the active arm had a mean PG-YBOCS score of 10 (n=5) with a SD of 9.35. The placebo arm is not included here as there were only two scores.|Enrollment was lower than expected and due to the low numbers of subjects completing the study (7 subjects (5 active and 2 placebo) completed all interventions) the numbers were not powerful enough to conduct a full analysis or provide any meaningful statistical analyses. We are including the mean and SD of each arm at the beginning and end of the study only as a comparison and not as a meaningful analysis.||||
71001092|NCT01057862|141509042|OTHER|We are including the mean and SD of each arm at the start and end of study only as a comparison and not a meaningful analysis. Since higher scores represent a more severe form of the disorder, a drop in scores is seen as an indicator that the treatment had an effect.|Mean Difference (Final Values)|14.2|STANDARD_DEVIATION|9.45|||TWO_SIDED||||||||The active treatment arm had a mean G-SAS score of 26.8 (n=5) at study start with a SD of 11.73. At end the active treatment arm had a mean G-SAS score of 12.6 (n=5) with a SD of 9.45. The placebo arm is not included as there were only 2 scores.|Enrollment was lower than expected and due to the low numbers of subjects completing the study (7 subjects (5 active and 2 placebo) completed all interventions) the numbers were not powerful enough to conduct a full analysis or provide any meaningful statistical analyses. We are including the mean and SD of each arm at the beginning and end of the study only as a comparison and not as a meaningful analysis.||||
71001093|NCT03434041|141509075|SUPERIORITY||Difference of Least Square (LS) Means|-2.0||||0.123|TWO_SIDED|95.0|-4.64|0.55||2-sided|Mixed-effects Model for Repeated Measure|||||0.55|-4.64|0.123
71001094|NCT03434041|141509076|SUPERIORITY||Difference of LS Means|-3.3|||||TWO_SIDED|95.0|-5.33|-1.33||||||||-1.33|-5.33|
71001095|NCT03434041|141509077|SUPERIORITY||Difference of LS Means|-1.0|||||TWO_SIDED|95.0|-2.96|0.97||||||||0.97|-2.96|
71001096|NCT03363165|141509129|SUPERIORITY||Mean Difference (Final Values)|-13.54||||0.7586|ONE_SIDED|90.0|-38.52||||ANCOVA|Adjusted for baseline six-minute walk distance, age, race, former smoker.|||||-38.52|0.7586
71001097|NCT03363165|141509130|SUPERIORITY||Mean Difference (Final Values)|2.25||||0.0298|ONE_SIDED|90.0|0.78||||ANCOVA|Adjusted for baseline maximal treadmill walking time, age, race, former smoker|||||0.78|0.0298
71001098|NCT03363165|141509131|SUPERIORITY||Mean Difference (Final Values)|0.69||||0.4019|ONE_SIDED|90.0|-3.1||||ANCOVA|Adjusted for baseline perfusion, age, race, former smoker.|||||-3.10|0.4019
71001099|NCT03363165|141509132|SUPERIORITY||Mean Difference (Final Values)|8.28||||0.208|ONE_SIDED|90.0|-5.37||||ANCOVA|Adjusted for baseline muscle measure, age, race, former smoker.|||||-5.37|0.2080
71001100|NCT03363165|141509133|SUPERIORITY||Mean Difference (Final Values)|2.02||||0.398|ONE_SIDED|90.0|-8.11||||ANCOVA|Adjusted for baseline WIQ distance score, age, race, former smoker|||||-8.11|0.3980
71100694|NCT02732145|141709684|SUPERIORITY|Question: Is there a difference in the incidence of rhagades of the Perineum among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of rhagades of the Perineum in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
70924188|NCT02596126|141340539|NON_INFERIORITY|"Non-inferiority hypothesis will be tested using a univariable Cox PH regression model including treatment group as the only covariate and stratified by country.~One-sided non-inferiority test on the primary endpoint where the alpha level will be set to 2.5%.~All statistical analyses will use 95% confidence intervals (CI).If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a log-rank test."|Hazard Ratio (HR)|0.7|||<|0.025|TWO_SIDED|95.0|0.54|0.9|||Regression, Cox|||||0.90|0.54|< 0.025
70924189|NCT02596126|141340539|SUPERIORITY|If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a logrank test.|||||<|0.05|||||||Log Rank|||||||< 0.05
70924190|NCT02596126|141340540|NON_INFERIORITY|"Non-inferiority hypothesis will be tested using a univariable Cox PH regression model including treatment group as the only covariate and stratified by country.~One-sided non-inferiority test on the primary endpoint where the alpha level will be set to 2.5%.~All statistical analyses will use 95% confidence intervals (CI).If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a log-rank test."|Hazard Ratio (HR)|0.67|||<|0.025|TWO_SIDED|95.0|0.47|0.97|||Regression, Cox|||||0.97|0.47|< 0.025
71001101|NCT03363165|141509134|SUPERIORITY||Mean Difference (Final Values)|-5.5||||0.7852|ONE_SIDED|90.0|-14.5||||ANCOVA|Adjusted for baseline SF-36 physical functioning score, age, race, former smoker.|||||-14.50|0.7852
71001102|NCT03363165|141509135|SUPERIORITY||Mean Difference (Final Values)|-5.14||||0.8414|ONE_SIDED|90.0|-11.76||||ANCOVA|Adjusted for baseline SF-36 physical functioning score, age, race, former smoker.|||||-11.76|0.8414
71001103|NCT03363165|141509136|SUPERIORITY||Mean Difference (Final Values)|-2.13||||0.5912|ONE_SIDED|90.0|-14.11||||ANCOVA|Adjusted for baseline WIQ distance score, age, race, former smoker.|||||-14.11|0.5912
71042312|NCT00292227|141594040|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.5||||||95.0|11.78|15.22|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||15.22|11.78|
71042313|NCT00292227|141594041|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.02||||||95.0|9.12|12.93|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||12.93|9.12|
71042314|NCT00292227|141594042|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.3||||||95.0|9.94|12.67|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||12.67|9.94|
71042315|NCT00292227|141594043|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.28||||||95.0|6.85|9.7|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||9.70|6.85|
71042316|NCT00292227|141594044|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.3||||||95.0|7.57|11.02|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||11.02|7.57|
71042317|NCT00292227|141594045|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.87||||||95.0|7.47|10.28|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||10.28|7.47|
71100695|NCT02732145|141709684|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with vulvar dermatosis?||||||0.0014|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with vulvar dermatosis.||||0.0014
71001104|NCT03363165|141509137|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.5442|ONE_SIDED|90.0|-25.47||||ANCOVA|Adjusted for baseline six-minute walk distance, age, race, former smoker.|||||-25.47|0.5442
71001105|NCT03363165|141509138|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.6603|ONE_SIDED|90.0|-2.11|||Adjusted for baseline pain-free treadmill walking time, age, race, former smoker.|ANCOVA||||||-2.11|0.6603
71001106|NCT03363165|141509139|SUPERIORITY||Mean Difference (Final Values)|-2.78||||0.5647|ONE_SIDED|90.0|-24.99||||ANCOVA|Adjusted for baseline six-minute walk distance, age, race, former smoker.|||||-24.99|0.5647
71001107|NCT02052141|141509164|SUPERIORITY||Mean difference|-0.4|STANDARD_DEVIATION|0.58||0.03|TWO_SIDED|90.0|-0.71|-0.1|||Paired t-test||The difference between treatment B over treatment A was estimated.|||-0.10|-0.71|0.03
70924191|NCT02596126|141340540|SUPERIORITY|If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a logrank test.|||||<|0.05|||||||Log Rank|||||||< 0.05
71001108|NCT02052141|141509165|SUPERIORITY||Mean difference|-0.7|STANDARD_DEVIATION|1.06||0.05|TWO_SIDED|90.0|-1.2|-0.11|||Paired t-test||The difference between treatment B over treatment A was estimated.|||-0.11|-1.20|0.05
71001109|NCT02052141|141509166|SUPERIORITY||Mean difference|-1.9|STANDARD_DEVIATION|2.82||0.04|TWO_SIDED|90.0|-3.31|-0.38|||Paired t-test||The difference between treatment B over treatment A was estimated.|||-0.38|-3.31|0.04
71001110|NCT02052141|141509167|SUPERIORITY||Mean difference|-0.2|STANDARD_DEVIATION|0.37||0.07|TWO_SIDED|90.0|-0.41|-0.03|||Paired t-test||The difference between treatment B over treatment A was estimated|||-0.03|-0.41|0.07
71001111|NCT02420990|141509173|SUPERIORITY||Slope|-0.31|||||TWO_SIDED||||||Latent Growth Curve Modeling|||||||
71001112|NCT02420990|141509173|SUPERIORITY||Slope|-0.67|||||TWO_SIDED||||||Latent Growth Curve Modeling|||||||
71001113|NCT02420990|141509173|SUPERIORITY||Slope|0.05||||0.05|TWO_SIDED||||||Latent Growth Curve Modeling|||||||0.05
71001114|NCT02420990|141509173|SUPERIORITY||Slope|0.56||||0.05|TWO_SIDED||||||Latent Growth Curve Modeling|||||||0.05
71001115|NCT02420990|141509173|SUPERIORITY||Slope|-0.72||||0.05|TWO_SIDED||||||Latent Growth Curve Modeling|||||||0.05
71001116|NCT02420990|141509174|SUPERIORITY||Slope|-1.78|||||TWO_SIDED||||||Linear Growth Curve Modeling|||||||
71001117|NCT02420990|141509174|SUPERIORITY||Slope|-0.64|||||TWO_SIDED||||||Latent Growth Curve Modeling|||||||
71001118|NCT02420990|141509174|SUPERIORITY||Slope|0.07|||||TWO_SIDED||||||Linear Growth Curve Modeling|||||||
71001119|NCT02420990|141509174|SUPERIORITY||Slope|0.0|||||TWO_SIDED||||||Latent Growth Curve Modeling|||||||
71001120|NCT02420990|141509174|SUPERIORITY||Slope|-1.44|||||TWO_SIDED||||||Latent Growth Curve Modeling|||||||
71001121|NCT02420990|141509175|SUPERIORITY||Mean Difference (Final Values)|6.6||||0.56|TWO_SIDED||||||Regression, Linear|||||||.56
71001122|NCT01784614|141509191|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean|0.96||||0.908|TWO_SIDED|90.0|0.56|1.65|||Mixed Models Analysis||Ratio of Geometric LS mean is WASO of 0.1 mg LY2624803 / Placebo.|||1.65|0.56|0.908
71001123|NCT01784614|141509191|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean|0.67||||0.083|TWO_SIDED|90.0|0.45|0.98|||Mixed Models Analysis||Ratio of Geometric LS mean is WASO of 1.0 mg LY2624803 / Placebo.|||0.98|0.45|0.083
71001124|NCT01784614|141509191|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean|0.53||||0.01|TWO_SIDED|90.0|0.36|0.78|||Mixed Models Analysis||Ratio of Geometric LS mean is WASO of 3.0 mg LY2624803 / Placebo.|||0.78|0.36|0.010
71001125|NCT01784614|141509191|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean|0.3|||<|0.001|TWO_SIDED|90.0|0.18|0.51|||Mixed Models Analysis||Ratio of Geometric LS mean is WASO of 6.0 mg LY2624803 / Placebo.|||0.51|0.18|<0.001
71001126|NCT02754661|141509200|NON_INFERIORITY|The non-inferiority margin (δ) is pre-defined to be 5% in this study. Posterior Probability was based on Bayesian analysis.|Posterior Probability Bayesian analysis|0.9999|||||TWO_SIDED||||||||Support the claim of statistical non-inferiority of CCE vs CTC|||||
71001127|NCT02754661|141509201|NON_INFERIORITY|Non-inferiority margin was set as 10%|Risk Difference (RD)|0.3732|||<|0.0001|TWO_SIDED|90.0|0.203|0.5434|||Farrington-Manning test||Based on Farrington-Manning Method|||0.5434|0.2030|<0.0001
71001128|NCT02754661|141509202|NON_INFERIORITY|Non-inferiority margin was set as 10%|Risk Difference (RD)|-0.026||||0.019|TWO_SIDED|90.0|-0.0847|0.0327|||Farrington-Manning test||Based on Farrington-Manning Method|||0.0327|-0.0847|0.0190
71001129|NCT02754661|141509203|NON_INFERIORITY|Non-inferiority margin was set as 10%|Risk Difference (RD)|0.0023||||0.093|TWO_SIDED|90.0|-0.1249|0.1249|||Farrington-Manning test||Based on Farrington-Manning Method|||0.1249|-0.1249|0.0930
71001130|NCT02754661|141509204|NON_INFERIORITY|Non-inferiority margin was set as 10%|Risk Difference (RD)|0.0607||||0.0034|TWO_SIDED|90.0|-0.0371|0.1585|||Farrington-Manning test||Based on Farrington-Manning Method|||0.1585|-0.0371|0.0034
71001131|NCT04423757|141509205|OTHER||Adjusted mean difference|3.38|STANDARD_ERROR_OF_MEAN|3.1||0.2796|TWO_SIDED|90.0|-1.81|8.56|||Mixed Models Analysis||Difference calculated as BI - Placebo.|Mixed effects model for repeated measures (MMRM) with fixed effects of treatment, visit, treatment by visit interaction, baseline, and baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.||8.56|-1.81|0.2796
71001132|NCT04423757|141509206|OTHER||Odds Ratio (OR)|0.276||||0.0468|TWO_SIDED|90.0|0.091|0.781|||Regression, Logistic||For the calculation of the odds ratio Placebo is taken as reference.|Logistic regression includes treatment as covariate.||0.781|0.091|0.0468
71001133|NCT04423757|141509207|OTHER||Adjusted mean difference|1.35|STANDARD_ERROR_OF_MEAN|3.5||0.698|TWO_SIDED|90.0|-4.47|7.17|||Mixed Models Analysis||Difference calculated as BI - Placebo.|S-Anxiety scale - Mixed effects model for repeated measures (MMRM) with fixed effects of treatment, visit, treatment by visit interaction, baseline, and baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.||7.17|-4.47|0.6980
71001134|NCT04423757|141509207|OTHER||Adjusted mean difference|3.54|STANDARD_ERROR_OF_MEAN|3.1||0.2589|TWO_SIDED|90.0|-1.67|8.76|||Mixed Models Analysis||Difference calculated as BI - Placebo.|T-Anxiety scale - Mixed effects model for repeated measures (MMRM) with fixed effects of treatment, visit, treatment by visit interaction, baseline, and baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.||8.76|-1.67|0.2589
71001135|NCT04423757|141509208|OTHER||Adjusted mean difference|0.51|STANDARD_ERROR_OF_MEAN|0.4||0.1863|TWO_SIDED|90.0|-0.13|1.15|||Mixed Models Analysis||Difference calculated as BI - Placebo.|Mixed effects model for repeated measures (MMRM) with fixed effects of treatment, visit, treatment by visit interaction, baseline, and baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.||1.15|-0.13|0.1863
71001136|NCT04423757|141509209|OTHER||Adjusted mean difference|0.65|STANDARD_ERROR_OF_MEAN|3.1||0.8326|TWO_SIDED|90.0|-4.46|5.76|||Mixed Models Analysis||Difference calculated as BI - Placebo.|Mixed effects model for repeated measures (MMRM) with fixed effects of treatment, visit, treatment by visit interaction, baseline, and baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.||5.76|-4.46|0.8326
71042318|NCT00292227|141594046|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.6||||||95.0|7.25|9.96|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||9.96|7.25|
71042319|NCT00292227|141594047|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.52||||||95.0|6.31|8.72|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||8.72|6.31|
71042320|NCT00292227|141594048|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.58||||||95.0|6.21|8.95|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||8.95|6.21|
71042321|NCT00292227|141594049|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.19||||||95.0|4.94|7.45|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||7.45|4.94|
71042322|NCT00442546|141594059|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.038|STANDARD_ERROR_OF_MEAN|0.37||0.9185||95.0|-0.766|0.691||A step-down procedure was used for multiple comparisons adjustment. If the difference between the high dose and placebo groups was statistically significant (p\<0.05), then the next step conducted where the low dose group was compared to placebo.|ANOVA|Least squares means from the analysis of variance (ANOVA) model with main effects of treatment and center and Baseline mean worst pain score.|Mean difference (final values) = Least squares mean difference|||0.691|-0.766|0.9185
71042323|NCT00442546|141594059|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.339|STANDARD_ERROR_OF_MEAN|0.371||0.3619||95.0|-1.07|0.392||A step-down procedure was used for multiple comparisons adjustment. If the difference between the high dose and placebo groups was statistically significant (p\<0.05), then the next step conducted where the low dose group was compared to placebo.|ANOVA|Least squares means from the ANOVA model with main effects of treatment and center and Baseline mean worst pain score.|Mean difference (final values) = Least squares mean difference|||0.392|-1.070|0.3619
71042324|NCT00442546|141594060|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.065|STANDARD_ERROR_OF_MEAN|19.426||0.4091||95.0|-54.332|22.203|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||22.203|-54.332|0.4091
71100696|NCT02732145|141709684|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with vulvar dermatosis.||||0.0000
71100697|NCT02732145|141709684|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Majora versus non-specific lesions of the Perineum in patients with vulvar dermatosis?||||||0.0414|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesion of Labia Majora versus non-specific lesions of the Perineum in patients with vulvar dermatosis.||||0.0414
71100698|NCT02732145|141709684|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with vulvodynia?||||||0.0898|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0898
71100699|NCT02732145|141709684|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with vulvodynia?||||||0.0008|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0008
71100700|NCT02732145|141709684|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Majora versus non-specific lesions of the Perineum in patients with vulvodynia?||||||0.0587|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Labia Majora versus non-specific lesions of the Perineum in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0587
71042325|NCT00442546|141594060|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.548|STANDARD_ERROR_OF_MEAN|19.388||0.4234||95.0|-53.74|22.645|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||22.645|-53.740|0.4234
71042326|NCT00442546|141594060|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-36.428|STANDARD_ERROR_OF_MEAN|16.517||0.0284||95.0|-68.972|-3.884|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||-3.884|-68.972|0.0284
70924192|NCT02596126|141340541|NON_INFERIORITY|"Non-inferiority hypothesis will be tested using a univariable Cox PH regression model including treatment group as the only covariate and stratified by country.~One-sided non-inferiority test on the primary endpoint where the alpha level will be set to 2.5%.~All statistical analyses will use 95% confidence intervals (CI).If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a log-rank test."|Hazard Ratio (HR)|0.71|||<|0.025|TWO_SIDED|95.0|0.48|1.05|||Regression, Cox|||||1.05|0.48|< 0.025
70924193|NCT02596126|141340541|SUPERIORITY|If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a logrank test.|||||<|0.05|||||||Log Rank|||||||< 0.05
70924194|NCT02596126|141340542|NON_INFERIORITY|"Non-inferiority hypothesis will be tested using a univariable Cox PH regression model including treatment group as the only covariate and stratified by country.~One-sided non-inferiority test on the primary endpoint where the alpha level will be set to 2.5%.~All statistical analyses will use 95% confidence intervals (CI).If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a log-rank test."|Hazard Ratio (HR)|0.7|||<|0.025|TWO_SIDED|95.0|0.39|1.26|||Regression, Cox|||||1.26|0.39|< 0.025
70924195|NCT02596126|141340542|SUPERIORITY|If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a logrank test.|||||<|0.05|||||||Log Rank|||||||< 0.05
70924196|NCT02596126|141340543|NON_INFERIORITY|"Non-inferiority hypothesis will be tested using a univariable Cox PH regression model including treatment group as the only covariate and stratified by country.~One-sided non-inferiority test on the primary endpoint where the alpha level will be set to 2.5%.~All statistical analyses will use 95% confidence intervals (CI).If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a log-rank test."|Hazard Ratio (HR)|0.96|||<|0.025|TWO_SIDED|95.0|0.57|1.63|||Regression, Cox|||||1.63|0.57|< 0.025
70924197|NCT02596126|141340543|SUPERIORITY|If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a logrank test.|||||<|0.05|||||||Log Rank|||||||< 0.05
70924198|NCT02596126|141340544|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|3.09|||<|0.05|TWO_SIDED|95.0|1.38|4.79|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||4.79|1.38|< 0.05
70924199|NCT02596126|141340545|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|-5.19|||<|0.05|TWO_SIDED|95.0|-12.73|2.35|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||2.35|-12.73|< 0.05
70924200|NCT02596126|141340546|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|7.09|||<|0.05|TWO_SIDED|95.0|5.57|8.62|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||8.62|5.57|< 0.05
70924201|NCT02596126|141340547|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|3.79|||<|0.05|TWO_SIDED|95.0|2.04|5.55|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||5.55|2.04|< 0.05
71001137|NCT04423757|141509210|OTHER||Adjusted mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.4||0.5567|TWO_SIDED|90.0|-0.43|0.89|||Mixed Models Analysis||Difference calculated as BI - Placebo.|Mixed effects model for repeated measures (MMRM) with fixed effects of treatment, visit, treatment by visit interaction, baseline, and baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.||0.89|-0.43|0.5567
71001138|NCT02709109|141509213|SUPERIORITY||Least Square (LS) mean difference|0.2||||0.8173|TWO_SIDED|95.0|-1.4|1.8|||Mixed-effects Model for Repeated Measure|||||1.8|-1.4|0.8173
71001139|NCT02709109|141509213|SUPERIORITY||LS mean difference|-0.7||||0.5903|TWO_SIDED|95.0|-3.3|1.9|||Mixed-effects Model for Repeated Measure|||||1.9|-3.3|0.5903
70924202|NCT02596126|141340548|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|5.26|||<|0.05|TWO_SIDED|95.0|3.59|6.94|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||6.94|3.59|< 0.05
71001140|NCT02709109|141509213|SUPERIORITY||LS mean difference|-0.7||||0.5917|TWO_SIDED|95.0|-3.4|1.9|||Mixed-effects Model for Repeated Measure|||||1.9|-3.4|0.5917
71001141|NCT02709109|141509213|SUPERIORITY||LS mean difference|-0.9||||0.5021|TWO_SIDED|95.0|-3.6|1.8|||Mixed-effects Model for Repeated Measure|||||1.8|-3.6|0.5021
71001142|NCT02709109|141509213|SUPERIORITY||LS mean difference|-1.6||||0.1382|TWO_SIDED|95.0|-3.8|0.5|||Mixed-effects Model for Repeated Measure|||||0.5|-3.8|0.1382
71001143|NCT02709109|141509213|SUPERIORITY||LS mean difference|0.9||||0.4962|TWO_SIDED|95.0|-1.7|3.5|||Mixed-effects Model for Repeated Measure|||||3.5|-1.7|0.4962
71001144|NCT05563714|141509216|SUPERIORITY||Odds Ratio (OR)|5.22|||<|0.001|TWO_SIDED|95.0|2.41|11.33|||generalized linear mixed effects model||Adjusted OR (base model)|Adjusted OR (base model), 95% CI - Includes clinician proceduralist vs non-proceduralist status as a co-variate.||11.33|2.41|<0.001
71001145|NCT05563714|141509216|SUPERIORITY||Odds Ratio (OR)|5.76|||<|0.001|TWO_SIDED|95.0|2.54|13.05|||generalized linear mixed effects model||Adjusted OR (expanded model)|Adjusted OR (expanded model), 95% CI - Adjusted for clinician proceduralist vs non-proceduralist status, patient age, sex, race, ethnicity, number of comorbidities, antiplatelet therapy used at baseline, and baseline use of H2 receptor antagonists.||13.05|2.54|<0.001
71001146|NCT05563714|141509217|SUPERIORITY||Odds Ratio (OR)|29.3|||<|0.001|TWO_SIDED|95.0|6.07|141.49|||generalized linear mixed effects model||Adjusted OR (base model)|Adjusted OR (base model), 95% CI - Included clinician proceduralist vs non-proceduralist status as a co-variate.||141.49|6.07|<0.001
71001147|NCT05563714|141509217|SUPERIORITY||Odds Ratio (OR)|43.6|||<|0.001|TWO_SIDED|95.0|6.56|289.88|||generalized linear mixed effects model||Adjusted OR (expanded model)|Adjusted OR (expanded model), 95% CI - Adjusted for clinician proceduralist vs non-proceduralist status, patient age, sex, race, ethnicity, number of comorbidities, antiplatelet therapy used at baseline, and baseline use of H2 receptor antagonists.||289.88|6.56|<0.001
71001148|NCT05563714|141509218|SUPERIORITY|Adjusted OR, 95% CI (base model) - Included clinician proceduralist vs non-proceduralist status as a co-variate.|Odds Ratio, log|19.86|||<|0.001|TWO_SIDED|95.0|10.63|29.09|||generalized linear mixed effects model|||We used generalized linear mixed effects modeling (logit link) to estimate the odds of medication optimization at week 7-10. This model included fixed effects for CNNF (vs. usual care), target provider specialty and size, and a random effect for clinician to account for the clustering of patients. We report the log odds ratios with corresponding confidence intervals for the main effect. The main effect was tested at a two-sided 5% significance level.||29.09|10.63|<0.001
71001149|NCT01815580|141509225|OTHER||||||>|0.75|||||||Chi-squared|||||||>0.75
71001150|NCT01815580|141509226|OTHER|||||||0.14|||||||t-test, 2 sided|||||||0.14
71001151|NCT01815580|141509227|OTHER||||||>|0.3|||||||Chi-squared|||||||>0.3
71001152|NCT01815580|141509228|OTHER||||||>|0.12|||||||Chi-squared|||||||>0.12
71001153|NCT01815580|141509229|OTHER||||||>|0.22|||||||Chi-squared|||||||>0.22
71100701|NCT02732145|141709684|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with impaired vulvar skin?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with impaired vulvar skin.||||1.0000
71001154|NCT02228564|141509230|NON_INFERIORITY|"The sample size calculation assumes the following:~The LIFESTREAM™ Covered Stent composite event rate is estimated at 10.5% The Performance Goal is set at 19.5% The Type 1 error, α = 0.05 (one-sided). The Type 2 error, β = 0.10 (Power = 1 - β = 90%). The calculated sample size is 139 subjects to be followed through the 9-month follow-up visit (using nQuery 7.0). To accommodate 10% censoring, the sample size is increased to 154."|||||<|0.0325|||||||Exact binomial test|||"H0: The proportion of subjects in the LifeStream™ Covered Stent group (PBBX) with events in the primary endpoint is greater than or equal to that of the PG of 19.5%.~H1: The proportion of subjects in the LifeStream™ Covered Stent group (PBBX) with events in the primary endpoint is less than that of the PG of 19.5%."||||<0.0325
71001155|NCT01998399|141509242|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Chi-squared|||Total enrollment only 25 patients and the study was terminated early due to low enrollment. No further statistical analysis was done.||||0.41
71001156|NCT01269047|141509256|OTHER||Mean Difference (Final Values)|-2.2|STANDARD_DEVIATION|2.4||0.04|TWO_SIDED|95.0|-4.2|-0.2|||ANOVA|||||-0.2|-4.2|0.04
71001157|NCT01269047|141509256|OTHER||Mean Difference (Final Values)|-3.5|STANDARD_DEVIATION|2.7||0.008|TWO_SIDED|95.0|-5.8|-1.3|||ANOVA|||||-1.3|-5.8|0.008
71001158|NCT01269047|141509256|OTHER||Mean Difference (Final Values)|-4.2|STANDARD_DEVIATION|2.6||0.003|TWO_SIDED|95.0|-6.4|-2.0|||ANOVA|||||-2.0|-6.4|0.003
71001159|NCT01269047|141509256|OTHER||Mean Difference (Final Values)|-0.66|STANDARD_DEVIATION|2.0||0.37|TWO_SIDED|95.0|-2.3|0.98|||ANOVA|||||0.98|-2.3|0.37
71001160|NCT01269047|141509257|OTHER||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|0.8||0.2|TWO_SIDED|95.0|-0.21|0.81|||t-test, 2 sided|||||0.81|-0.21|0.2
71001161|NCT01269047|141509257|OTHER||Mean Difference (Final Values)|0.13|STANDARD_DEVIATION|0.6||0.48|TWO_SIDED|95.0|-0.25|0.5|||t-test, 2 sided|||||0.50|-0.25|0.48
71001162|NCT01269047|141509257|OTHER||Mean Difference (Final Values)|0.23|STANDARD_DEVIATION|0.6||0.18|TWO_SIDED|95.0|-0.12|0.57|||t-test, 2 sided|||||0.57|-0.12|0.18
71001163|NCT01269047|141509257|OTHER||Mean Difference (Final Values)|-0.004|STANDARD_DEVIATION|1.0||1|TWO_SIDED|95.0|-0.62|0.61|||t-test, 2 sided|||||0.61|-0.62|1.0
71001164|NCT00418717|141509324|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||||95.0|-0.25|0.06||||||||0.06|-0.25|
71001165|NCT00249795|141509335|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.992||||0.857|TWO_SIDED|95.0|0.907|1.085||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 4.5% level to account for multiplicity.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of any component of the composite event in Irbesartan group versus Placebo group.|||1.085|0.907|0.8570
71001166|NCT00249795|141509336|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.12|TWO_SIDED|95.0|0.869|1.016||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 1% level to account for multiplicity.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of any component of the composite event in Irbesartan group versus Placebo group.|||1.016|0.869|0.1200
71001167|NCT00249795|141509337|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.916||||0.2162|TWO_SIDED|95.0|0.796|1.053||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 5% level.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of a stroke in Irbesartan group versus Placebo group.|||1.053|0.796|0.2162
71042327|NCT00442546|141594060|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-28.985|STANDARD_ERROR_OF_MEAN|16.57||0.0816||95.0|-61.632|3.663|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||3.663|-61.632|0.0816
71042328|NCT00442546|141594060|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.759|STANDARD_ERROR_OF_MEAN|11.752||0.8147||95.0|-20.446|25.964|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||25.964|-20.446|0.8147
71042329|NCT00442546|141594060|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.182|STANDARD_ERROR_OF_MEAN|11.589||0.7187||95.0|-27.064|18.7|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||18.700|-27.064|0.7187
71042330|NCT00442546|141594060|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.356|STANDARD_ERROR_OF_MEAN|10.148||0.7416||95.0|-23.516|16.804|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||16.804|-23.516|0.7416
71042331|NCT00442546|141594060|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.574|STANDARD_ERROR_OF_MEAN|9.283||0.2577||95.0|-29.017|7.869|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||7.869|-29.017|0.2577
71042332|NCT00442546|141594060|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|17.387||0.9982||95.0|-36.431|36.352|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||36.352|-36.431|0.9982
71042333|NCT00442546|141594060|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.325|STANDARD_ERROR_OF_MEAN|22.184||0.5552||95.0|-59.756|33.107|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||33.107|-59.756|0.5552
71042334|NCT00442546|141594060|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-40.0|STANDARD_ERROR_OF_MEAN|24.655||0.2032||95.0|-118.463|38.463|||ANOVA||Mean difference (final values) = Least squares mean difference|144 hours||38.463|-118.463|0.2032
71042335|NCT00442546|141594060|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-138.5|STANDARD_ERROR_OF_MEAN|37.661||0.0348||95.0|-258.354|-18.646|||ANOVA||Mean difference (final values) = Least squares mean difference|144 hours||-18.646|-258.354|0.0348
71042336|NCT00442546|141594061|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.136|STANDARD_ERROR_OF_MEAN|4.499||0.3602||95.0|-4.79|13.062|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 2||13.062|-4.790|0.3602
71042337|NCT00442546|141594061|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.573|STANDARD_ERROR_OF_MEAN|4.637||0.7352||95.0|-7.626|10.771|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 2||10.771|-7.626|0.7352
71042338|NCT00442546|141594061|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.86|STANDARD_ERROR_OF_MEAN|6.156||0.6435||95.0|-9.392|15.111|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 4||15.111|-9.392|0.6435
71042339|NCT00442546|141594061|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.237|STANDARD_ERROR_OF_MEAN|6.361||0.6123||95.0|-9.422|15.895|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 4||15.895|-9.422|0.6123
71042340|NCT00442546|141594061|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.65|STANDARD_ERROR_OF_MEAN|7.663||0.6356||95.0|-11.683|18.984|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 6/ET||18.984|-11.683|0.6356
71042341|NCT00442546|141594061|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.909|STANDARD_ERROR_OF_MEAN|7.747||0.907||95.0|-14.593|16.411|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 6/ET||16.411|-14.593|0.9070
71042342|NCT00442546|141594062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1190.65|STANDARD_ERROR_OF_MEAN|123.062||0.0656||95.0|-2754.304|373.004|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Acetylsalicylic Acid, 72 hours||373.004|-2754.304|0.0656
71042343|NCT00442546|141594062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|16.2|STANDARD_ERROR_OF_MEAN|142.1||0.9277||95.0|-1789.352|1821.752|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Acetylsalicylic Acid, 72 hours||1821.752|-1789.352|0.9277
71042344|NCT00442546|141594062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.771|STANDARD_ERROR_OF_MEAN|62.692||0.935||95.0|-263.972|275.515|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Ketorolac, 24 hours||275.515|-263.972|0.9350
71042345|NCT00442546|141594062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|26.243|STANDARD_ERROR_OF_MEAN|44.33||0.6139||95.0|-164.494|216.98|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Ketorolac, 24 hours||216.980|-164.494|0.6139
71042346|NCT00442546|141594062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.92|STANDARD_ERROR_OF_MEAN|9.96||0.776||95.0|-25.451|19.611|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Ketorolac, 48 hours||19.611|-25.451|0.7760
71001168|NCT00249795|141509338|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.014||||0.759|TWO_SIDED|95.0|0.927|1.11||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 5% level.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of death in Irbesartan group versus Placebo group.|||1.110|0.927|0.7590
71001169|NCT00249795|141509339|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.897||||0.0369|TWO_SIDED|95.0|0.809|0.993||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 5% level.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of HF episodes in Irbesartan group versus Placebo group.|||0.993|0.809|0.0369
71001170|NCT00249795|141509340|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.863||||0.0175|TWO_SIDED|95.0|0.763|0.975||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 5% level.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of hospitalization for Heart Failure in Irbesartan group versus Placebo group.|||0.975|0.763|0.0175
71001171|NCT00249795|141509341|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.008||||0.8377|TWO_SIDED|95.0|0.93|1.093||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 5% level.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of hospitalization for other CV cause in Irbesartan group versus Placebo group.|||1.093|0.930|0.8377
71001172|NCT02460978|141509347|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.0579|<|0.0001|TWO_SIDED|95.0|-0.49|-0.26|||Mixed Models Analysis|Model is adjusted for baseline HbA1c, treatment, week, randomization stratum, week\*treatment, and week\*baseline HbA1c.||Difference vs. placebo in adjusted mean change from baseline||-0.26|-0.49|<0.0001
71001173|NCT02460978|141509347|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.0578|<|0.0001|TWO_SIDED|95.0|-0.53|-0.3|||Mixed Models Analysis|Model is adjusted for baseline HbA1c, treatment, week, randomization stratum, week\*treatment, and week\*baseline HbA1c.||Difference vs. placebo in adjusted mean change from baseline||-0.30|-0.53|<0.0001
71001174|NCT02460978|141509348|SUPERIORITY||Mean Difference (Final Values)|-10.78|STANDARD_ERROR_OF_MEAN|1.5291|<|0.0001|TWO_SIDED|95.0|-13.73|-7.72|||Mixed Models Analysis|Adjusted for ln(baseline), treatment, week, randomization stratum, week\*treatment, week\*ln(baseline).||Difference vs. placebo in adjusted mean percentage change from baseline||-7.72|-13.73|<0.0001
71001175|NCT02460978|141509348|SUPERIORITY||Mean Difference (Final Values)|-11.08|STANDARD_ERROR_OF_MEAN|1.5331|<|0.0001|TWO_SIDED|95.0|-14.04|-8.02|||Mixed Models Analysis|Adjusted for ln(baseline), treatment, week, randomization stratum, week\*treatment, and week\*ln(baseline).||Difference vs. placebo in adjusted mean percentage change from baseline||-8.02|-14.04|<0.0001
71001176|NCT02460978|141509349|SUPERIORITY||Mean Difference (Final Values)|-3.21|STANDARD_ERROR_OF_MEAN|0.3829|<|0.0001|TWO_SIDED|95.0|-3.96|-2.45|||Mixed Models Analysis|Adjusted for ln(baseline), treatment, week, randomization stratum, week\*treatment, and week\*ln(baseline).||Difference vs. placebo in adjusted mean percentage change from baseline||-2.45|-3.96|<0.0001
71001177|NCT02460978|141509349|SUPERIORITY||Mean Difference (Final Values)|-3.74|STANDARD_ERROR_OF_MEAN|0.3812|<|0.0001|TWO_SIDED|95.0|-4.49|-2.99|||Mixed Models Analysis|Adjusted for ln(baseline), treatment, week, randomization stratum, week\*treatment, and week\*ln(baseline).||Difference vs. placebo in adjusted mean percentage change from baseline||-2.99|-4.49|<0.0001
71042347|NCT00442546|141594062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.61|STANDARD_ERROR_OF_MEAN|6.833||0.819||95.0|-17.066|13.846|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Ketorolac, 48 hours||13.846|-17.066|0.8190
71042348|NCT00442546|141594062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-69.235|STANDARD_ERROR_OF_MEAN|390.483||0.8603||95.0|-861.171|722.7|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 24 hours||722.700|-861.171|0.8603
71042349|NCT00442546|141594062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.395|STANDARD_ERROR_OF_MEAN|384.376||0.9642||95.0|-796.945|762.155|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 24 hours||762.155|-796.945|0.9642
71042350|NCT00442546|141594062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|93.693|STANDARD_ERROR_OF_MEAN|484.957||0.8476||95.0|-880.865|1068.251|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 48 hours||1068.251|-880.865|0.8476
71001178|NCT02460978|141509350|SUPERIORITY||Mean Difference (Final Values)|-15.66|STANDARD_ERROR_OF_MEAN|2.3468|<|0.0001|TWO_SIDED|95.0|-20.26|-11.05|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.||Difference vs. placebo in adjusted mean change from baseline||-11.05|-20.26|<0.0001
71001179|NCT02460978|141509350|SUPERIORITY||Mean Difference (Final Values)|-19.74|STANDARD_ERROR_OF_MEAN|2.3419|<|0.0001|TWO_SIDED|95.0|-24.34|-15.14|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.||Difference vs. placebo in adjusted mean change from baseline||-15.14|-24.34|<0.0001
71001180|NCT02460978|141509351|SUPERIORITY||Mean Difference (Final Values)|-9.85|STANDARD_ERROR_OF_MEAN|2.4519|<|0.0001|TWO_SIDED|95.0|-14.66|-5.03|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.||Difference vs. placebo in adjusted mean change from baseline||-5.03|-14.66|<0.0001
71001181|NCT02460978|141509351|SUPERIORITY||Mean Difference (Final Values)|-9.36|STANDARD_ERROR_OF_MEAN|2.4487||0.0001|TWO_SIDED|95.0|-14.16|-4.55|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.||Difference vs. placebo in adjusted mean change from baseline||-4.55|-14.16|0.0001
71001182|NCT02460978|141509352|SUPERIORITY||Mean Difference (Final Values)|9.02|STANDARD_ERROR_OF_MEAN|1.0415|<|0.0001|TWO_SIDED|95.0|6.97|11.06|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.||Difference vs. placebo in adjusted mean change from baseline||11.06|6.97|<0.0001
71001183|NCT02460978|141509352|SUPERIORITY||Mean Difference (Final Values)|10.7|STANDARD_ERROR_OF_MEAN|1.0396|<|0.0001|TWO_SIDED|95.0|8.66|12.74|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.||Difference vs. placebo in adjusted mean change from baseline||12.74|8.66|<0.0001
71001184|NCT02460978|141509353|SUPERIORITY||Odds Ratio (OR)|2.71|STANDARD_ERROR_OF_MEAN|0.2058|<|0.0001|TWO_SIDED|95.0|1.81|4.06|||Regression, Logistic|Adjusted for baseline HbA1c and randomization strata||Odds Ratio vs. Placebo||4.06|1.81|<0.0001
71001185|NCT02460978|141509353|SUPERIORITY||Odds Ratio (OR)|3.07|STANDARD_ERROR_OF_MEAN|0.2054|<|0.0001|TWO_SIDED|95.0|2.05|4.6|||Regression, Logistic|Adjusted for baseline HbA1c and randomization strata||Odds Ratio vs. Placebo||4.60|2.05|<0.0001
71001186|NCT03549429|141509360|SUPERIORITY||Percent difference|8.0||||0.03|TWO_SIDED|95.0|1.5|14.4|||McNemar|||We compared the proportion of patients who had postoperative eyelid erythema with Tegaderm™ to those who had postop eyelid erythema with EyeGard®.||14.4|1.5|0.03
71001187|NCT03549429|141509361|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.23|TWO_SIDED||||||t-test, 2 sided|paired||||||0.23
71001188|NCT03061812|141509374|SUPERIORITY||Hazard Ratio (HR)|1.46||||0.0051|TWO_SIDED|95.0|1.17|1.82|||Log Rank|Two-sided p-value stratified by the randomization stratification factors.|Calculated using a Cox proportional hazards regression model, with treatment and randomization stratification factors as covariates.|||1.82|1.17|0.0051
71001189|NCT03061812|141509375|SUPERIORITY||Hazard Ratio (HR)|1.51|||<|0.0001|TWO_SIDED|95.0|1.22|1.87|||Log Rank|Two-sided p-value stratified by the randomization stratification factors.|Calculated using a Cox proportional hazards regression model, with treatment and randomization stratification factors as covariates.|||1.87|1.22|< 0.0001
71001190|NCT03061812|141509376|SUPERIORITY||LS Mean of Difference|-0.5|STANDARD_ERROR_OF_MEAN|2.62|||TWO_SIDED|95.0|-5.66|4.65||||||||4.65|-5.66|
71001191|NCT03061812|141509377|SUPERIORITY||Odds Ratio (OR)|0.68||||0.3352|TWO_SIDED|95.0|0.39|1.18|||Cochran-Mantel-Haenszel|Stratified by the randomization stratification factors.||||1.18|0.39|0.3352
71001192|NCT03061812|141509378|SUPERIORITY||Odds Ratio (OR)|0.73||||0.0358|TWO_SIDED|95.0|0.47|1.12|||Cochran-Mantel-Haenszel|Stratified by the randomization stratification factors.||||1.12|0.47|0.0358
71001193|NCT02408484|141509434|OTHER|||||||0.0028||||||p-value for the change in MCF from baseline to 1 hour post infusion for the firstBLEED population|ANOVA|||||||0.0028
71001194|NCT02408484|141509434|OTHER|||||||0.0002||||||p-value for the change in MCF from baseline to 1 hour post infusion for the BLEED population|ANOVA|||||||0.0002
71001195|NCT03805971|141509444|SUPERIORITY|||||||0.0003|||||||Fisher Exact|||"The objective of the test is to assess if the pCLE feature full chia seed sign is found statistically more frequently in the benign pleura group than in the malignant pleural infiltrations group."||||0.0003
71001196|NCT03805971|141509444|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"The objective is to assess if the abnormal tissular architecture is significantly more frequently found in the malignant pleural infiltrations group than in the benign pleura group."||||<0.0001
71001197|NCT03805971|141509444|SUPERIORITY|||||||0.0052|||||||Fisher Exact|||"The objective is to assess if the pCLE feature cellular shape homogeneity is found statistically more frequently in the benign pleura group than in the malignant pleural infiltrations group."||||0.0052
71001198|NCT03805971|141509444|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"The objective is to assess if dysplastic vessels are more frequently found in the malignant pleural infiltrations group than in the benign pleura group."||||<0.0001
71001199|NCT00407550|141509502|SUPERIORITY|||||||0.015|||||||Log Rank|||||||0.015
71001200|NCT00407550|141509503|SUPERIORITY|||||||0.56|||||||Log Rank|||||||0.56
71001201|NCT00443846|141509505|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower bound of the 95% confidence interval of the difference (Group 1 - Group 2) in seroprotection rate was greater than -10%.|Difference (Group 1 - Group 2)|0.0|||||TWO_SIDED|95.0|-3.7|3.7||||||Analysis of non-inferiority was based on the Miettinen and Nurminen method||3.7|-3.7|
71001202|NCT01599806|141509537|NON_INFERIORITY_OR_EQUIVALENCE|-12.5%|Difference of symp resolution rates|4.0|||||TWO_SIDED|95.0|-2.39|10.42|||Unstratified Miettinen & Nurminen method|||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of symptomatic resolution rates ≤ non-inferiority margin||10.42|-2.39|
71001203|NCT01599806|141509538|NON_INFERIORITY_OR_EQUIVALENCE|-12.5%|Diff of favorable combined resp rates|6.7|||||TWO_SIDED|95.0|0.3|13.12|||Unstratified Miettinen & Nurminen method|||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable combined response rates ≤ non-inferiority margin||13.12|0.30|
71001204|NCT01599806|141509539|NON_INFERIORITY_OR_EQUIVALENCE|-12.5%|Diff of favorable response rates|6.4|||||TWO_SIDED|95.0|0.33|12.36|||Unstratified Miettinen & Nurminen method|||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates ≤ non-inferiority margin||12.36|0.33|
71042351|NCT00442546|141594062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|105.543|STANDARD_ERROR_OF_MEAN|457.374||0.8185||95.0|-813.584|1024.67|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 48 hours||1024.670|-813.584|0.8185
71042352|NCT00442546|141594062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-682.304|STANDARD_ERROR_OF_MEAN|495.241||0.1792||95.0|-1696.759|332.15|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 72 hours||332.150|-1696.759|0.1792
71042353|NCT00442546|141594062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-250.439|STANDARD_ERROR_OF_MEAN|501.808||0.6216||95.0|-1278.347|777.469|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 72 hours||777.469|-1278.347|0.6216
71042354|NCT00442546|141594063|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-494.0|STANDARD_ERROR_OF_MEAN|301.253||0.1996||95.0|-1452.72|464.72|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Acetylsalicylic Acid, Week 2.||464.720|-1452.720|0.1996
71042355|NCT00442546|141594063|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-195.15|STANDARD_ERROR_OF_MEAN|368.958||0.6335||95.0|-1369.338|979.038|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Acetylsalicylic Acid, Week 2.||979.038|-1369.338|0.6335
71042356|NCT00442546|141594063|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-27.291|STANDARD_ERROR_OF_MEAN|302.355||0.929||95.0|-657.992|603.41|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 2||603.410|-657.992|0.9290
71001205|NCT01599806|141509540|SUPERIORITY_OR_OTHER||Diff of favorable response rates|0.4|||||TWO_SIDED|95.0|-2.7|3.56|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||3.56|-2.70|
71001206|NCT01599806|141509541|SUPERIORITY_OR_OTHER||Diff of favorable response rates|7.3|||||TWO_SIDED|95.0|0.68|13.81|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||13.81|0.68|
71042357|NCT00442546|141594063|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|34.787|STANDARD_ERROR_OF_MEAN|256.969||0.8937||95.0|-501.241|570.815|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 2||570.815|-501.241|0.8937
71042358|NCT00442546|141594063|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|198.937|STANDARD_ERROR_OF_MEAN|491.153||0.6912||95.0|-847.93|1245.804|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 4||1245.804|-847.930|0.6912
71042359|NCT00442546|141594063|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|185.728|STANDARD_ERROR_OF_MEAN|349.047||0.6024||95.0|-558.248|929.704|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 4||929.704|-558.248|0.6024
71042360|NCT00442546|141594063|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-256.921|STANDARD_ERROR_OF_MEAN|407.391||0.5372||95.0|-1120.551|606.709|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 6/ET||606.709|-1120.551|0.5372
71042361|NCT00442546|141594063|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-287.032|STANDARD_ERROR_OF_MEAN|328.227||0.3948||95.0|-982.843|408.778|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 6/ET||408.778|-982.843|0.3948
71042362|NCT00442546|141594064|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-121.5|STANDARD_ERROR_OF_MEAN|1169.654||0.9341|TWO_SIDED|95.0|-14983.36|14740.362|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|||14740.362|-14983.36|0.9341
71042363|NCT00442546|141594066|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|302.9|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|TWO_SIDED|95.0|302.9|302.9|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|||302.900|302.900|<0.0001
71042364|NCT00442546|141594070|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.121|STANDARD_ERROR_OF_MEAN|0.087||0.1661||95.0|-0.293|0.051|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.051|-0.293|0.1661
71042365|NCT00442546|141594070|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.081|STANDARD_ERROR_OF_MEAN|0.088||0.3604||95.0|-0.254|0.093|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.093|-0.254|0.3604
71042366|NCT00442546|141594070|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.126|STANDARD_ERROR_OF_MEAN|0.083||0.1299||95.0|-0.29|0.037|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.037|-0.290|0.1299
71042367|NCT00442546|141594070|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.129|STANDARD_ERROR_OF_MEAN|0.082||0.1167||95.0|-0.29|0.032|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.032|-0.290|0.1167
71042368|NCT00442546|141594070|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.057|STANDARD_ERROR_OF_MEAN|0.09||0.5271||95.0|-0.234|0.12|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.120|-0.234|0.5271
71001207|NCT01599806|141509542|SUPERIORITY_OR_OTHER||Diff of favorable response rates|0.2|||||TWO_SIDED|95.0|-1.21|1.72|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||1.72|-1.21|
71001208|NCT01599806|141509543|SUPERIORITY_OR_OTHER||Diff of favorable response rates|8.8|||||TWO_SIDED|95.0|2.27|15.24|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||15.24|2.27|
71001209|NCT01599806|141509544|SUPERIORITY_OR_OTHER||Diff of favorable response rates|10.9|||||TWO_SIDED|95.0|2.86|18.85|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||18.85|2.86|
71001210|NCT01599806|141509545|SUPERIORITY_OR_OTHER||Diff of favorable response rates|0.2|||||TWO_SIDED|95.0|-1.17|1.68|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||1.68|-1.17|
71001211|NCT01599806|141509546|SUPERIORITY_OR_OTHER||Diff of favorable response rates|7.3|||||TWO_SIDED|95.0|0.88|13.74|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||13.74|0.88|
71042369|NCT00442546|141594070|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.038|STANDARD_ERROR_OF_MEAN|0.09||0.6731||95.0|-0.215|0.139|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.139|-0.215|0.6731
71042370|NCT00442546|141594070|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.098||0.5936||95.0|-0.247|0.142|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.142|-0.247|0.5936
71042371|NCT00442546|141594070|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.094||0.8368||95.0|-0.206|0.167|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.167|-0.206|0.8368
71042372|NCT00442546|141594070|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.111||0.8659||95.0|-0.242|0.204|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.204|-0.242|0.8659
71042373|NCT00442546|141594070|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.041|STANDARD_ERROR_OF_MEAN|0.112||0.7151||95.0|-0.266|0.184|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.184|-0.266|0.7151
71001212|NCT01599806|141509547|SUPERIORITY_OR_OTHER||Diff of favorable response rates|9.7|||||TWO_SIDED|95.0|1.72|17.55|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||17.55|1.72|
71042374|NCT00442546|141594070|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.097|STANDARD_ERROR_OF_MEAN|0.077||0.2121||95.0|-0.249|0.056|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.056|-0.249|0.2121
71042375|NCT00442546|141594070|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.077||0.5607||95.0|-0.197|0.107|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.107|-0.197|0.5607
71100702|NCT02732145|141709684|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with impaired vulvar skin?||||||0.1352|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with impaired vulvar skin.||||0.1352
71001213|NCT01599806|141509548|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-1.4|||||TWO_SIDED|95.0|-4.07|1.02|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||1.02|-4.07|
71042376|NCT00442546|141594070|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.077||0.7797||95.0|-0.13|0.173|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.173|-0.130|0.7797
71042377|NCT00442546|141594070|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.079||0.8761||95.0|-0.143|0.167|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.167|-0.143|0.8761
71042378|NCT00442546|141594070|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.067||0.8619||95.0|-0.121|0.144|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.144|-0.121|0.8619
71042379|NCT00442546|141594070|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.068||0.7256||95.0|-0.111|0.159|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.159|-0.111|0.7256
71042380|NCT00442546|141594070|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.061||0.8659||95.0|-0.11|0.131|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.131|-0.110|0.8659
71042381|NCT00442546|141594070|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.146|STANDARD_ERROR_OF_MEAN|0.063||0.0203||95.0|0.023|0.27|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.270|0.023|0.0203
71042382|NCT00442546|141594071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.041|STANDARD_ERROR_OF_MEAN|0.074||0.5791||95.0|-0.187|0.105|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.105|-0.187|0.5791
71042383|NCT00442546|141594071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.031|STANDARD_ERROR_OF_MEAN|0.075||0.6829||95.0|-0.178|0.117|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.117|-0.178|0.6829
71042384|NCT00442546|141594071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.07||0.4516||95.0|-0.19|0.085|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.085|-0.190|0.4516
71100703|NCT02732145|141709684|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Majora versus non-specific lesions of the Perineum in patients with impaired vulvar skin?||||||0.1352|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesion of Labia Majora versus non-specific lesions of the Perineum in patients with impaired vulvar skin.||||0.1352
71100704|NCT02732145|141709684|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of Mons Pubis versus specific lesions of Labia Majora in patients with vulvar dermatosis?||||||0.0002|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Mons Pubis versus specific lesions of Labia Majora in patients with vulvar dermatosis.||||0.0002
71100705|NCT02732145|141709684|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of Mons Pubis versus specific lesions of the Perineum in patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Mons Pubis versus specific lesions of the Perineum in patients with vulvar dermatosis.||||0.0000
71100706|NCT02732145|141709684|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of Labia Majora versus specific lesions of the Perineum in patients with vulvar dermatosis?||||||0.0854|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Labia Majora versus specific lesions of the Perineum in patients with vulvar dermatosis.||||0.0854
71001214|NCT01599806|141509549|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-0.1|||||TWO_SIDED|95.0|-4.23|4.03|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||4.03|-4.23|
71042385|NCT00442546|141594071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.071|STANDARD_ERROR_OF_MEAN|0.069||0.3014||95.0|-0.207|0.064|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.064|-0.207|0.3014
71042386|NCT00442546|141594071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.075||0.7628||95.0|-0.171|0.125|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.125|-0.171|0.7628
71042387|NCT00442546|141594071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.028|STANDARD_ERROR_OF_MEAN|0.075||0.711||95.0|-0.176|0.12|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.120|-0.176|0.7110
71042388|NCT00442546|141594071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.026|STANDARD_ERROR_OF_MEAN|0.079||0.7382||95.0|-0.183|0.13|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.130|-0.183|0.7382
71042389|NCT00442546|141594071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.034|STANDARD_ERROR_OF_MEAN|0.076||0.6586||95.0|-0.183|0.116|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.116|-0.183|0.6586
71042390|NCT00442546|141594071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.025|STANDARD_ERROR_OF_MEAN|0.084||0.7691||95.0|-0.195|0.145|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.145|-0.195|0.7691
71100707|NCT02732145|141709685|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Anterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71042391|NCT00442546|141594071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.057|STANDARD_ERROR_OF_MEAN|0.085||0.507||95.0|-0.229|0.115|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.115|-0.229|0.5070
71042392|NCT00442546|141594071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.036|STANDARD_ERROR_OF_MEAN|0.066||0.5802||95.0|-0.166|0.093|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.093|-0.166|0.5802
71042393|NCT00442546|141594071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.065||0.919||95.0|-0.122|0.136|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.136|-0.122|0.9190
71100708|NCT02732145|141709685|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Interlabial Sulci among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Interlabial Sulci in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71100709|NCT02732145|141709685|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Minora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Labia Minora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71100710|NCT02732145|141709685|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Posterior Commissure among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Posterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy.. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71100711|NCT02732145|141709685|SUPERIORITY|Question: Is there a difference in the incidence of erythema of the Anterior Commissure among patients from different groups?||||||0.0199|||||||Chi-squared|||"Parameter: The incidence of erythema of the Anterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0199
71100712|NCT02732145|141709685|SUPERIORITY|Question: Is there a difference in the incidence of erythema of Interlabial Sulci among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Interlabial Sulci in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71100713|NCT02732145|141709685|SUPERIORITY|Question: Is there a difference in the incidence of erythema of Labia Minora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Labia Minora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71100714|NCT02732145|141709685|SUPERIORITY|Question: Is there a difference in the incidence of erythema of the Posterior Commissure among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Posterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71042394|NCT00442546|141594071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.026|STANDARD_ERROR_OF_MEAN|0.059||0.6559||95.0|-0.09|0.143|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.143|-0.090|0.6559
71042395|NCT00442546|141594071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.06||0.8552||95.0|-0.108|0.13|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.130|-0.108|0.8552
71042396|NCT00442546|141594071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.048||0.6364||95.0|-0.072|0.117|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.117|-0.072|0.6364
71001215|NCT01599806|141509550|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|1.3|||||TWO_SIDED|95.0|-3.71|6.3|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||6.30|-3.71|
71001216|NCT01599806|141509551|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-1.3|||||TWO_SIDED|95.0|-3.64|0.55|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||0.55|-3.64|
71001217|NCT01599806|141509552|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|1.2|||||TWO_SIDED|95.0|-2.03|4.56|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||4.56|-2.03|
71042397|NCT00442546|141594071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.049||0.2127||95.0|-0.035|0.157|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.157|-0.035|0.2127
71042398|NCT00442546|141594071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.047||0.8746||95.0|-0.086|0.101|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.101|-0.086|0.8746
71042399|NCT00442546|141594071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.048||0.0286||95.0|0.011|0.202|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.202|0.011|0.0286
71042400|NCT00442546|141594072|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.165|STANDARD_ERROR_OF_MEAN|0.102||0.1078||95.0|-0.367|0.036|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.036|-0.367|0.1078
71042401|NCT00442546|141594072|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.048|STANDARD_ERROR_OF_MEAN|0.103||0.6406||95.0|-0.252|0.155|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.155|-0.252|0.6406
71042402|NCT00442546|141594072|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.108|STANDARD_ERROR_OF_MEAN|0.092||0.2404||95.0|-0.289|0.073|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.073|-0.289|0.2404
71042403|NCT00442546|141594072|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.149|STANDARD_ERROR_OF_MEAN|0.09||0.1005||95.0|-0.327|0.029|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.029|-0.327|0.1005
71042404|NCT00442546|141594072|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.136|STANDARD_ERROR_OF_MEAN|0.108||0.2109||95.0|-0.349|0.078|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.078|-0.349|0.2109
71100715|NCT02732145|141709685|SUPERIORITY|Question: Is there a difference in the incidence of fissures of Interlabial Sulci among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of fissures of Interlabial Sulci in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71100716|NCT02732145|141709685|SUPERIORITY|Question: Is there a difference in the incidence of fissures of the Posterior Commissure among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of fissures of the Posterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71100717|NCT02732145|141709685|SUPERIORITY|Question: Is there a difference in the incidence of smoothness of the Anterior Commissure among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Anterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71100718|NCT02732145|141709685|SUPERIORITY|Question: Is there a difference in the incidence of smoothness of Interlabial Sulci among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of smoothness of Interlabial Sulci in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71100719|NCT02732145|141709685|SUPERIORITY|Question: Is there a difference in the frequency of smoothness of Labia Minora among patients from different groups?||||||0.0024|||||||Chi-squared|||"Parameter: The frequency of smoothness of Labia Minora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0024
71100720|NCT02732145|141709685|SUPERIORITY|Question: Is there a difference in the incidence of smoothness of the Posterior Commissure among patients from different groups?||||||0.0205|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Posterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0205
71001218|NCT01599806|141509553|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|2.2|||||TWO_SIDED|95.0|-2.9|7.24|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||7.24|-2.90|
71001219|NCT01599806|141509554|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-1.9|||||TWO_SIDED|95.0|-4.3|0.04|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||0.04|-4.30|
71001220|NCT01599806|141509555|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|1.1|||||TWO_SIDED|95.0|-2.07|4.32|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||4.32|-2.07|
71001221|NCT01599806|141509556|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|2.0|||||TWO_SIDED|95.0|-2.94|6.91|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||6.91|-2.94|
71001222|NCT01599806|141509557|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-0.1|||||TWO_SIDED|95.0|-1.99|1.61|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||1.61|-1.99|
71042405|NCT00442546|141594072|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.128|STANDARD_ERROR_OF_MEAN|0.108||0.2399||95.0|-0.342|0.086|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.086|-0.342|0.2399
71042406|NCT00442546|141594072|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.131|STANDARD_ERROR_OF_MEAN|0.108||0.2272||95.0|-0.346|0.083|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.083|-0.346|0.2272
71042407|NCT00442546|141594072|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.104||0.4417||95.0|-0.285|0.125|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.125|-0.285|0.4417
71042408|NCT00442546|141594072|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.009|STANDARD_ERROR_OF_MEAN|0.144||0.9502||95.0|-0.299|0.281|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.281|-0.299|0.9502
71042409|NCT00442546|141594072|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.135|STANDARD_ERROR_OF_MEAN|0.144||0.355||95.0|-0.426|0.156|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.156|-0.426|0.3550
71042410|NCT00442546|141594072|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.122|STANDARD_ERROR_OF_MEAN|0.092||0.1888||95.0|-0.304|0.06|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.060|-0.304|0.1888
71042411|NCT00442546|141594072|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.081|STANDARD_ERROR_OF_MEAN|0.092||0.3774||95.0|-0.262|0.1|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.100|-0.262|0.3774
71042412|NCT00442546|141594072|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.087||0.9452||95.0|-0.178|0.166|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.166|-0.178|0.9452
71042413|NCT00442546|141594072|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.026|STANDARD_ERROR_OF_MEAN|0.089||0.7663||95.0|-0.201|0.148|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.148|-0.201|0.7663
71042414|NCT00442546|141594072|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.041|STANDARD_ERROR_OF_MEAN|0.074||0.5777||95.0|-0.104|0.186|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.186|-0.104|0.5777
71042415|NCT00442546|141594072|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.075||0.2916||95.0|-0.069|0.227|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.227|-0.069|0.2916
71042416|NCT00442546|141594072|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.069||0.8389||95.0|-0.15|0.122|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.122|-0.150|0.8389
71042417|NCT00442546|141594072|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.07||0.0734||95.0|-0.012|0.266|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.266|-0.012|0.0734
71042418|NCT00442546|141594073|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.084||0.1949||95.0|-0.276|0.057|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.057|-0.276|0.1949
71100721|NCT02732145|141709685|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with vulvar dermatosis?||||||0.0158|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with vulvar dermatosis.||||0.0158
71100722|NCT02732145|141709685|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with vulvar dermatosis?||||||0.0001|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with vulvar dermatosis.||||0.0001
71042419|NCT00442546|141594073|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.052|STANDARD_ERROR_OF_MEAN|0.085||0.5431||95.0|-0.22|0.116|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.116|-0.220|0.5431
71042420|NCT00442546|141594073|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.095|STANDARD_ERROR_OF_MEAN|0.077||0.2164||95.0|-0.247|0.056|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.056|-0.247|0.2164
71042421|NCT00442546|141594073|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.117|STANDARD_ERROR_OF_MEAN|0.076||0.1251||95.0|-0.266|0.033|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.033|-0.266|0.1251
71042422|NCT00442546|141594073|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.073|STANDARD_ERROR_OF_MEAN|0.088||0.4079||95.0|-0.247|0.101|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.101|-0.247|0.4079
71042423|NCT00442546|141594073|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.066|STANDARD_ERROR_OF_MEAN|0.088||0.4562||95.0|-0.24|0.108|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.108|-0.240|0.4562
71042424|NCT00442546|141594073|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.093||0.4526||95.0|-0.254|0.114|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.114|-0.254|0.4526
71042425|NCT00442546|141594073|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.089||0.6186||95.0|-0.221|0.132|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.132|-0.221|0.6186
71042426|NCT00442546|141594073|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.018|STANDARD_ERROR_OF_MEAN|0.109||0.8712||95.0|-0.237|0.202|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.202|-0.237|0.8712
71001223|NCT01599806|141509558|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|3.7|||||TWO_SIDED|95.0|0.41|7.16|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||7.16|0.41|
71001224|NCT01599806|141509559|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|4.0|||||TWO_SIDED|95.0|-1.0|9.05|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||9.05|-1.00|
71001225|NCT01599806|141509560|SUPERIORITY_OR_OTHER||Diff of clin cure rates in All patients|0.0|||||TWO_SIDED|95.0|-10.4|10.1|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen||10.1|-10.4|
71001226|NCT01599806|141509561|SUPERIORITY_OR_OTHER||Diff of clin cure rates in All patients|1.4|||||TWO_SIDED|95.0|-7.8|10.2|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen||10.2|-7.8|
71001227|NCT01599806|141509562|SUPERIORITY_OR_OTHER||Diff of clin cure rates in All patients|1.2|||||TWO_SIDED|95.0|-7.5|9.2|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen||9.2|-7.5|
71001228|NCT01599806|141509563|SUPERIORITY_OR_OTHER||Diff of favorable response rates|2.0|||||TWO_SIDED|95.0|-13.18|16.89|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||16.89|-13.18|
71001229|NCT01599806|141509564|SUPERIORITY_OR_OTHER||Diff of favorable response rates|8.0|||||TWO_SIDED|95.0|-10.03|25.21|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||25.21|-10.03|
71042427|NCT00442546|141594073|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.078|STANDARD_ERROR_OF_MEAN|0.11||0.4784||95.0|-0.3|0.143|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.143|-0.300|0.4784
71042428|NCT00442546|141594073|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.084|STANDARD_ERROR_OF_MEAN|0.075||0.2635||95.0|-0.232|0.064|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.064|-0.232|0.2635
71100723|NCT02732145|141709685|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with vulvar dermatosis?||||||0.028|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with vulvar dermatosis.||||0.0280
71042429|NCT00442546|141594073|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|0.075||0.6009||95.0|-0.187|0.108|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.108|-0.187|0.6009
71042430|NCT00442546|141594073|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.013|STANDARD_ERROR_OF_MEAN|0.073||0.8559||95.0|-0.13|0.156|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.156|-0.130|0.8559
71042431|NCT00442546|141594073|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.074||0.9841||95.0|-0.147|0.144|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.144|-0.147|0.9841
71001230|NCT01599806|141509565|SUPERIORITY_OR_OTHER||Diff of favorable response rates|7.5|||||TWO_SIDED|95.0|-9.91|24.01|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||24.01|-9.91|
71001231|NCT01599806|141509566|SUPERIORITY_OR_OTHER|||||||0.038|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.038
71001232|NCT01599806|141509567|SUPERIORITY_OR_OTHER|||||||0.129|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.129
71001233|NCT01599806|141509568|SUPERIORITY_OR_OTHER|||||||0.08|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.080
71001234|NCT01599806|141509569|SUPERIORITY_OR_OTHER|||||||0.155|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.155
71001235|NCT01585168|141509621|OTHER||Mean Difference (Net)|2.4109||||0.032|TWO_SIDED|||||P value was adjusted for multiple comparisons using FWE (family wise error) correction.|t-test, 2 sided|A Paired t-test was performed to explore the difference between two groups.|FHN was found to have lower mean BOLD activation while given drug compared to placebo in amygdala.|||||0.032
71001236|NCT01585168|141509621|OTHER||Median Difference (Net)|3.6615||||0.125|TWO_SIDED||||||t-test, 2 sided|||||||0.125
71001237|NCT01585168|141509624|OTHER||Mean Difference (Net)|2.7264||||0.356|TWO_SIDED|||||P value was adjusted for multiple comparisons using FWE (family wise error) correction.|t-test, 2 sided||FHP was found to have lower mean BOLD activation while given drug compared to placebo in anterior cingulate cortex.|||||0.356
71001238|NCT01585168|141509624|OTHER||Median Difference (Net)|1.8348||||0.009|TWO_SIDED||||||t-test, 2 sided|||||||0.009
71001239|NCT03326583|141509648|SUPERIORITY|||||||0.05|||||||Fisher Exact|||||||.05
71001240|NCT03326583|141509649|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||.05
71001241|NCT03326583|141509650|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||.05
71001242|NCT03326583|141509651|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||.05
71001243|NCT01525667|141509659|SUPERIORITY_OR_OTHER||Least Square Means (LSM) Difference|25.74|STANDARD_ERROR_OF_MEAN|8.94||0.0067|TWO_SIDED|95.0|7.61|43.86|||Mixed Models Analysis||LSM difference =LSM Low dose - LSM Placebo|||43.86|7.61|0.0067
71001244|NCT01525667|141509659|SUPERIORITY_OR_OTHER||Least Square Means (LSM) difference|14.93|STANDARD_ERROR_OF_MEAN|10.8||0.18|TWO_SIDED|95.0|-7.12|36.99|||Mixed Models Analysis||LSM difference= LSM High Dose - LSM Placebo|||36.99|-7.12|0.18
71001245|NCT01525667|141509660|SUPERIORITY_OR_OTHER||LSM Difference|18.03|STANDARD_ERROR_OF_MEAN|5.97||0.004|TWO_SIDED|95.0|6.03|30.02|||Mixed Models Analysis|||||30.02|6.03|0.004
71001246|NCT01525667|141509660|SUPERIORITY_OR_OTHER||LSM difference|9.23|STANDARD_ERROR_OF_MEAN|6.91||0.19|TWO_SIDED|95.0|-4.72|23.17|||Mixed Models Analysis|||||23.17|-4.72|0.19
71001247|NCT01525667|141509661|SUPERIORITY_OR_OTHER||LSM Difference|6.45|STANDARD_ERROR_OF_MEAN|4.64||0.19|TWO_SIDED|95.0|-3.5|16.41|||ANCOVA|||||16.41|-3.50|0.19
71042432|NCT00442546|141594073|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.025|STANDARD_ERROR_OF_MEAN|0.061||0.6771||95.0|-0.095|0.146|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.146|-0.095|0.6771
71042433|NCT00442546|141594073|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.062||0.3717||95.0|-0.067|0.178|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.178|-0.067|0.3717
71042434|NCT00442546|141594073|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.058||0.9863||95.0|-0.114|0.116|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.116|-0.114|0.9863
71001248|NCT01525667|141509661|SUPERIORITY_OR_OTHER||LSM difference|5.49|STANDARD_ERROR_OF_MEAN|4.56||0.25|TWO_SIDED|95.0|-4.29|15.26|||ANCOVA|||||15.26|-4.29|0.25
71001249|NCT01525667|141509662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.19||0.4|TWO_SIDED|95.0|-0.21|0.53|||Mixed Models Analysis|||||0.53|-0.21|0.4
71001250|NCT01525667|141509662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.011|STANDARD_ERROR_OF_MEAN|0.2||0.96|TWO_SIDED||||||Mixed Models Analysis|||||||0.96
71001251|NCT01525667|141509663|SUPERIORITY_OR_OTHER||LSM difference|16.81|STANDARD_ERROR_OF_MEAN|8.37||0.05|TWO_SIDED|95.0|0.16|33.47|||Mixed Models Analysis|||||33.47|0.16|0.05
71001252|NCT01525667|141509663|SUPERIORITY_OR_OTHER||LSM difference|10.7|STANDARD_ERROR_OF_MEAN|9.01||0.24|TWO_SIDED|95.0|-7.26|28.65|||Mixed Models Analysis|||||28.65|-7.26|0.24
71001253|NCT01235507|141509670|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
71001254|NCT01235507|141509670|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
71001255|NCT01235507|141509670|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
71001256|NCT01235507|141509672|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
71001257|NCT01235507|141509672|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
71001258|NCT01235507|141509672|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
71001259|NCT01235507|141509673|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
71001260|NCT01235507|141509673|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
71001261|NCT01235507|141509673|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
71001262|NCT01235507|141509674|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
71001263|NCT01235507|141509674|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
71001264|NCT01235507|141509674|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
71042435|NCT00442546|141594073|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.059||0.0355||95.0|0.009|0.243|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.243|0.009|0.0355
71042436|NCT00442546|141594074|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.049|STANDARD_ERROR_OF_MEAN|0.202||0.8071||95.0|-0.35|0.449|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.449|-0.350|0.8071
71042437|NCT00442546|141594074|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.204||0.8282||95.0|-0.359|0.447|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.447|-0.359|0.8282
71042438|NCT00442546|141594074|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.025|STANDARD_ERROR_OF_MEAN|0.192||0.8972||95.0|-0.353|0.403|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.403|-0.353|0.8972
71042439|NCT00442546|141594074|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.19||0.8159||95.0|-0.329|0.418|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.418|-0.329|0.8159
71042440|NCT00442546|141594074|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.034|STANDARD_ERROR_OF_MEAN|0.188||0.8577||95.0|-0.337|0.405|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.405|-0.337|0.8577
71042441|NCT00442546|141594074|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.044|STANDARD_ERROR_OF_MEAN|0.188||0.8158||95.0|-0.415|0.327|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.327|-0.415|0.8158
71042442|NCT00442546|141594074|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.195||0.4243||95.0|-0.229|0.541|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.541|-0.229|0.4243
71042443|NCT00442546|141594074|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.205|STANDARD_ERROR_OF_MEAN|0.187||0.2742||95.0|-0.164|0.574|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.574|-0.164|0.2742
71042444|NCT00442546|141594074|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.069|STANDARD_ERROR_OF_MEAN|0.116||0.5569||95.0|-0.302|0.165|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.165|-0.302|0.5569
71042445|NCT00442546|141594074|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.116||0.3762||95.0|-0.13|0.336|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.336|-0.130|0.3762
71042446|NCT00442546|141594074|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.155||0.6203||95.0|-0.229|0.383|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.383|-0.229|0.6203
71042447|NCT00442546|141594074|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.155||0.3343||95.0|-0.155|0.455|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.455|-0.155|0.3343
71042448|NCT00442546|141594074|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.157|STANDARD_ERROR_OF_MEAN|0.128||0.2213||95.0|-0.096|0.41|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.410|-0.096|0.2213
71042449|NCT00442546|141594074|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.131||0.2863||95.0|-0.118|0.399|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.399|-0.118|0.2863
71042450|NCT00442546|141594074|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.082||0.305||95.0|-0.077|0.245|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.245|-0.077|0.3050
71042451|NCT00442546|141594074|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.083||0.0155||95.0|0.039|0.368|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.368|0.039|0.0155
71001265|NCT01235507|141509675|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
71001266|NCT01235507|141509675|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
71001267|NCT01235507|141509675|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
71100724|NCT02732145|141709685|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
71001268|NCT01235507|141509676|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
71001269|NCT01235507|141509676|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
71001270|NCT01235507|141509676|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
71001271|NCT01235507|141509677|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
71001272|NCT01235507|141509677|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
71042452|NCT00442546|141594074|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.087||0.9243||95.0|-0.164|0.181|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.181|-0.164|0.9243
71042453|NCT00442546|141594074|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.089||0.0201||95.0|0.033|0.386|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.386|0.033|0.0201
71100725|NCT02732145|141709685|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Labia Minora in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Labia Minora in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
71042454|NCT00442546|141594075|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.321||0.1537||95.0|-1.093|0.173|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.173|-1.093|0.1537
71042455|NCT00442546|141594075|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.398|STANDARD_ERROR_OF_MEAN|0.324||0.2208||95.0|-1.038|0.241|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.241|-1.038|0.2208
71001273|NCT01235507|141509677|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
71001274|NCT01363258|141509680|OTHER|Generalized linear mixed models fitted with binomial (logit link) and gamma (log link) distributions, with additional dispersion parameters, were used to estimate and test intervention effects in terms of occurrence and intensity of CRBs, respectively. Inference was conducted in the link scale, but inverse-link estimates in the original scales (proportions and CRB scores, for the binomial and gamma models, respectively) were computed to facilitate interpretation.|Effect size|-0.16||||0.1433|TWO_SIDED||||||Time by group interaction test|||||||0.1433
71001275|NCT01641081|141509707|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2644|STANDARD_ERROR_OF_MEAN|0.0148|<|0.0001|TWO_SIDED|95.0|0.2353|0.2934|||Mixed Models Analysis|Treatment and period as fixed effects, and baseline FEV1 values at each period as a covariate||||0.2934|0.2353|<0.0001
71001276|NCT01641081|141509707|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2524|STANDARD_ERROR_OF_MEAN|0.0156|<|0.0001|TWO_SIDED|95.0|0.2218|0.283|||Mixed Models Analysis|Treatment and period as fixed effects, and baseline FEV1 values at each period as a covariate||||0.2830|0.2218|<0.0001
71001277|NCT01641081|141509707|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2242|STANDARD_ERROR_OF_MEAN|0.0153|<|0.0001|TWO_SIDED|95.0|0.1941|0.2544|||Mixed Models Analysis|Treatment and period as fixed effects, and baseline FEV1 values at each period as a covariate||||0.2544|0.1941|<0.0001
70924203|NCT02596126|141340549|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|4.55|||<|0.05|TWO_SIDED|95.0|-4.35|13.46|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||13.46|-4.35|< 0.05
71001278|NCT01641081|141509707|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2174|STANDARD_ERROR_OF_MEAN|0.0146|<|0.0001|TWO_SIDED|95.0|0.1887|0.2461|||Mixed Models Analysis|Treatment and period as fixed effects, and baseline FEV1 values at each period as a covariate||||0.2461|0.1887|<0.0001
71001279|NCT03011775|141509717|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|The threshold for statistical significance was P value of .05||||||<0.05
71001280|NCT03011775|141509718|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||>0.05
71001281|NCT03011775|141509720|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||>0.05
71001282|NCT03011775|141509721|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71001283|NCT03011775|141509723|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71001284|NCT03011775|141509724|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
71001285|NCT03011775|141509725|SUPERIORITY||||||=|0.3|||||||Wilcoxon (Mann-Whitney)|||||||=0.3
71001286|NCT00588380|141509726|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Kruskal-Wallis|||Using the Kruskal-Wallis test (general allelic model), we assessed univariate associations of rs6923761 genotype with Phi Total in the presence of either glucose alone, glucose and 0.75 pmol/kg/min GLP-1 or glucose and 1.5 pmol/kg/min GLP-1 If the p-value for the overall univariate test of association was \<0.1, then the associations for specific genotype pairs (e.g.: 1,1 vs. 1,2 or 2,2 vs. 1,1) were also examined using a Mann-Whitney Rank Sum test.||||0.11
71001287|NCT00588380|141509727|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Kruskal-Wallis|||All data are presented as means ± SEM. Using the Kruskal-Wallis test (general allelic model), we assessed univariate associations of genotype with ΦTotal||||0.09
71001288|NCT01000025|141509734|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0||||0.506|TWO_SIDED|95.0|0.83|1.21||Stratified by stratification factors at randomization except study center, but included K-Ras mutation status.1-sied p-value.|Log Rank|Stratified by stratification factors at randomization except study center, but included K-Ras mutation status.||The trial was designed to detect a 25% deduction in risk of death with PF-804 with 90% power using a 1-sided 2.5% level significance test. The sample size was estimated as 720 patients.||1.21|0.83|0.506
71001289|NCT01000025|141509735|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79||||0.043|TWO_SIDED|95.0|0.61|1.03||1-sided p-value|Log Rank|Stratified by stratification factors at randomization except study center.||||1.03|0.61|0.043
71001290|NCT01000025|141509736|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98||||0.46|TWO_SIDED|95.0|0.67|1.44||1-sided pvalue|Log Rank|||||1.44|0.67|0.46
71001291|NCT01000025|141509737|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.66|||<|0.0001|TWO_SIDED|95.0|0.55|0.79|||Log Rank|Stratified by stratification factors at randomization except study center, but included K-Ras mutation status.||||0.79|0.55|< 0.0001
71001292|NCT01000025|141509738|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.11||||0.001|TWO_SIDED|95.0|1.84|20.3|||Cochran-Mantel-Haenszel|||||20.3|1.84|0.001
71001293|NCT00996593|141509746|SUPERIORITY_OR_OTHER||Percentage of participants|65.0|||||TWO_SIDED|95.0|50.0|80.0|||||The estimated value represents the percentage of participants with complete response.|||80|50|
71001294|NCT00996593|141509747|SUPERIORITY_OR_OTHER||Percentage of participants|23.0|||||TWO_SIDED|95.0|10.0|35.0|||||The estimated value represents the percentage of participants with complete response.|||35|10|
71001295|NCT00996593|141509748|SUPERIORITY_OR_OTHER||Percentage of participants|38.0|||||TWO_SIDED|95.0|22.0|53.0|||||The estimated value represents the percentage of participants with complete response.|||53|22|
71001296|NCT00996593|141509749|SUPERIORITY_OR_OTHER||Percentage of participants|28.0|||||TWO_SIDED|95.0|14.0|41.0|||||The estimated value represents the percentage of participants with complete response.|||41|14|
71042456|NCT00442546|141594075|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.068|STANDARD_ERROR_OF_MEAN|0.325||0.8355||95.0|-0.707|0.572|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.572|-0.707|0.8355
71001297|NCT00996593|141509754|SUPERIORITY_OR_OTHER||Percentage of responders|75.0||||1|TWO_SIDED|95.0|54.0|96.0||With prior response|Fisher Exact||The estimated value represents the percentage of participants with response.|||96|54|1.0
71001298|NCT00996593|141509754|SUPERIORITY_OR_OTHER||Percentage of responders|70.0||||1|TWO_SIDED|95.0|51.0|88.0||Without prior response|Fisher Exact||The estimated value represents the percentage of participants with response.|||88|51|1.0
71001299|NCT00996593|141509755|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Fisher Exact|||||||0.8
71001300|NCT00996593|141509756|SUPERIORITY_OR_OTHER||Percentage of responders|31.0||||1|TWO_SIDED|95.0|9.0|54.0||With prior response|Fisher Exact||The estimated value represents the percentage of participants with response.|||54|9|1.0
71001301|NCT00996593|141509756|SUPERIORITY_OR_OTHER||Percentage of responders|17.0||||1|TWO_SIDED|95.0|2.0|33.0||Without prior response|Fisher Exact||The estimated value represents the percentage of participants with response.|||33|2|1.0
71001302|NCT00996593|141509757|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Fisher Exact|||||||0.2
71001303|NCT00996593|141509758|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Log Rank|||||||0.9
71001304|NCT02738580|141509771|SUPERIORITY||Mean Difference (Final Values)|0.29|STANDARD_DEVIATION|0.26|<|0.05|TWO_SIDED|||||The proportion of patients with elevated Progesterone on last day of stimulation(\>1.5 ng/mL) was compared between both groups using the Chi-square test.|t-test, 2 sided|||||||<0.05
71001305|NCT02738580|141509772|SUPERIORITY||||||<|0.49|||||||t-test, 1 sided|||||||<0.49
71001306|NCT01000818|141509773|NON_INFERIORITY_OR_EQUIVALENCE|The raltegravir AUC0-12 hr geometric mean ratio (raltegravir + omeprazole/raltegravir) is noniferior at less than 2.0.|Geometric Mean Ratio|1.39||||||95.0|1.04|1.84||||||||1.84|1.04|
71001307|NCT01000818|141509773|NON_INFERIORITY_OR_EQUIVALENCE|The raltegravir AUC0-12 hr geometric mean ratio (raltegravir + omeprazole/raltegravir) is noniferior at less than 2.0.|Geometric Mean Ratio|1.45||||||95.0|1.09|1.93||||||||1.93|1.09|
71001308|NCT00583661|141509824|NON_INFERIORITY_OR_EQUIVALENCE|Sample size determination: A sample of 24 subjects followed for approximately 100 days provides greater than 80% power to conclude that, with a 1-sided alpha=0.025 test, the SAE rate of the EXCOR (assumed to be 0.21 per patient-day) is less than 0.25 per patient-day. This sample size was estimated using 10,000 simulations of this study. A total enrollment of 48 subjects (24 per cohort) were enrolled and implanted with the EXCOR® Pediatric.|Poisson confidence interval|0.25|||<|0.05|TWO_SIDED|95.0|0.0|0.25||A Poisson exact confidence interval was calculated and the critical-value method was used for the significance testing. Success was defined as the upper bound of the 95% Poisson exact confidence interval being less than 0.25.|Poisson confidence interval|||Ho: EXCOR® SAE Rate \>=0.25 Ha: EXCOR® SAE Rate \< 0.25 Where serious adverse event (SAE) rate is calculated as the total number of serious adverse events divided by the sum of days all patients are on the EXCOR® Pediatric device, and 0.25 serious adverse events per patient-day is the success criterion. Study success in terms of safety will be demonstrated by the upper bound of a two-sided 95% Poisson exact confidence interval being less than 0.25.||0.25|0|<0.05
71001309|NCT04010370|141509827|SUPERIORITY||||||<|0.001|||||||Spearman correlation|||Correlation of McAuley index with PREDIM index at baseline.||||<0.001
71001310|NCT04010370|141509828|SUPERIORITY|||||||0.319|||||||Spearman correlation|||Correlation of Belfiore index with PREDIM index at baseline.||||0.319
71001311|NCT04010370|141509829|SUPERIORITY|||||||0.27|||||||Spearman correlation|||Correlation of Cederholm index with PREDIM index at baseline.||||0.27
71001312|NCT04010370|141509830|SUPERIORITY|||||||0.246|||||||Spearman correlation|||Correlation of Avignon index with PREDIM index at baseline.||||0.246
71001313|NCT04010370|141509831|SUPERIORITY|||||||0.259|||||||Spearman correlation|||Correlation of Matsuda index with PREDIM index at baseline.||||0.259
71001314|NCT04010370|141509832|SUPERIORITY|||||||0.69|||||||Spearman correlation|||Correlation of Gutt index with PREDIM index at baseline.||||0.69
71001315|NCT04010370|141509833|SUPERIORITY|||||||0.022|||||||Spearman correlation|||Correlation of Stumvoll index with PREDIM index at baseline.||||0.022
71001316|NCT04010370|141509834|SUPERIORITY|||||||0.69|||||||Spearman correlation|||Correlation of HOMA-IR index with PREDIM index at baseline.||||0.69
71001317|NCT04010370|141509835|SUPERIORITY|||||||0.69|||||||Spearman correlation|||Correlation of ISI index with PREDIM index at baseline.||||0.69
71001318|NCT04010370|141509836|SUPERIORITY|||||||0.541|||||||Spearman correlation|||Correlation of Raynaud index with PREDIM index at baseline.||||0.541
71001319|NCT04010370|141509837|SUPERIORITY|||||||0.69|||||||Spearman correlation|||Correlation of QUICKI index with PREDIM index at baseline.||||0.69
71001320|NCT04010370|141509838|SUPERIORITY|||||||0.531|||||||Spearman correlation|||Correlation of FIRI index with PREDIM index at baseline.||||0.531
71001321|NCT04010370|141509839|SUPERIORITY|||||||0.726|||||||Spearman correlation|||Correlation of Bennett index with PREDIM index at baseline.||||0.726
71001322|NCT04010370|141509840|SUPERIORITY|||||||0.787|||||||Spearman correlation|||Correlation of TyG index with PREDIM index at baseline.||||0.787
71001323|NCT01324687|141509841|SUPERIORITY_OR_OTHER||Rate ratio|0.8387||||0.017|TWO_SIDED|95.0|0.7261|0.9689|||GEE / Poisson regression models|||Rate ratio of ED use rate of the intervention group as compared to the control group.||0.9689|0.7261|0.017
71001324|NCT02120352|141509879|OTHER||Difference in Percentage|3.7|||||TWO_SIDED|95.0|-4.8|12.2|||||Comparison between CAB LA 600 mg+RPV LA 900 mg IM-Q8W and CAB 30 mg+ABC/3TC QD|||12.2|-4.8|
71001325|NCT02120352|141509879|OTHER||Difference in Percentage|2.8|||||TWO_SIDED|95.0|-5.8|11.5|||||Comparison between CAB LA 400 mg+RPV LA 600 mg IM-Q4W and CAB 30 mg+ABC/3TC QD|||11.5|-5.8|
71001326|NCT01610206|141509944|EQUIVALENCE|To estimate the progression-free survival hazard ratio of the combination of weekly gemcitabine and pazopanib compared to weekly gemcitabine alone in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer.|Hazard Ratio (HR)|0.81||||0.019|TWO_SIDED|95.0|0.61|1.07|||non-parametric weighted Tarone-Ware test|||||1.07|0.61|0.019
71042457|NCT00442546|141594075|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.222|STANDARD_ERROR_OF_MEAN|0.331||0.5024||95.0|-0.875|0.43|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.430|-0.875|0.5024
71001327|NCT00444964|141509946|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71001328|NCT00444964|141509947|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71042458|NCT00442546|141594075|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.067|STANDARD_ERROR_OF_MEAN|0.282||0.8116||95.0|-0.489|0.624|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.624|-0.489|0.8116
71001329|NCT00444964|141509948|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71001330|NCT00166517|141509949|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was assessed versus a constant, 85%, based on historical data.||||||0.003||95.0||||p ≥.85, where p is the proportion of subjects who achieved ≥3-fold rise from baseline in the group that received RotaTeq®|Exact test of proportion|Exact test of proportion, based on binomial distribution||||||0.003
71001331|NCT00878644|141509988|SUPERIORITY||Risk Difference (RD)|7.3||||0.14|TWO_SIDED|95.0|-1.5|16.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was used adjusting for age category at time of randomization (\<2 years, 2 to \<12 years, or \>=12 years)||||16.1|-1.5|0.14
71001332|NCT00878644|141509989|SUPERIORITY||Risk Difference (RD)|9.1||||0.13|TWO_SIDED|95.0|-1.8|19.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was used adjusting for age category at time of randomization (\<2 years, 2 to \<12 years, or \>=12 years)||||19.9|-1.8|0.13
71001333|NCT00878644|141509990|SUPERIORITY|||||||0.13|||||||Stratified Mann-Whitney Test|Test stratified by age category (\<2 years, 2 to \<12 years, or \>=12 years), for continuous (NOT categorized as reported above) 1-year change in VABS-II|||As the (nonparametric) comparison treated 1-year deaths as worst possible outcomes and worst possible 1-year VABS-II as next worst possible outcomes, using change in VABS-II for other participants alive at 1 year, no relevant estimation of effect size is possible for this secondary outcome.|||0.13
71001334|NCT00878644|141509991|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|"Test used the continuous (NOT categorized as reported above) neuropsychological scores, with Lowest Possible Score treated as lowest possible value."||||||0.81
71001335|NCT02371980|141509997|SUPERIORITY||Hazard Ratio (HR)|0.517||||0.006|TWO_SIDED|95.0|0.323|0.828||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 5mg Vs Double-blind Placebo||0.828|0.323|0.006
71001336|NCT02371980|141509997|SUPERIORITY||Hazard Ratio (HR)|0.476||||0.002|TWO_SIDED|95.0|0.296|0.767||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 10 mg Vs Double-blind Placebo||0.767|0.296|0.002
71001337|NCT02371980|141509997|SUPERIORITY||Hazard Ratio (HR)|0.483||||0.003|TWO_SIDED|95.0|0.298|0.782||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 20 mg Vs Double-blind Placebo||0.782|0.298|0.003
71001338|NCT02371980|141509998|SUPERIORITY||Least Squares Mean (LSM) Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.59||0.421|TWO_SIDED|95.0|-1.63|0.68|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2||0.68|-1.63|0.421
71001339|NCT02371980|141509998|SUPERIORITY||Least Squares Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.589||0.037|TWO_SIDED|95.0|-2.39|-0.08|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2||-0.08|-2.39|0.037
71001340|NCT02371980|141509998|SUPERIORITY||Least Squares Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.592||0.488|TWO_SIDED|95.0|-1.57|0.75|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2||0.75|-1.57|0.488
71042459|NCT00442546|141594075|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.099|STANDARD_ERROR_OF_MEAN|0.288||0.7325||95.0|-0.667|0.469|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.469|-0.667|0.7325
71042460|NCT00442546|141594075|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.066|STANDARD_ERROR_OF_MEAN|0.278||0.8133||95.0|-0.614|0.482|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.482|-0.614|0.8133
70924204|NCT02596126|141340550|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|7.11|||<|0.05|TWO_SIDED|95.0|5.55|8.67|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||8.67|5.55|< 0.05
70924205|NCT02596126|141340551|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|6.6|||<|0.05|TWO_SIDED|95.0|4.93|8.27|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||8.27|4.93|< 0.05
70924206|NCT02596126|141340552|SUPERIORITY|Time to first event will be investigated using Cox proportional hazards regression. Hazard ratios and 95% confidence intervals will be obtained from the Cox proportional hazards model. P-values will be obtained using the log-rank test.|Hazard Ratio (HR)|1.42|||<|0.05|TWO_SIDED|95.0|0.97|2.07|||Log Rank|||Statistical analysis title - Non-cardiovascular death||2.07|0.97|< 0.05
70924207|NCT05063994|141340598|NON_INFERIORITY|Non-inferiority of Chronocort to Cortef was declared if the 95% CI for the difference in biochemical response rates between the 2 treatment arms (Chronocort minus Cortef) was wholly above minus 15 percentage points.|Treatment Difference|25.7|STANDARD_ERROR_OF_MEAN|11.82||0.0003|TWO_SIDED|95.0|2.5|48.9||One-sided non-inferiority. The Ge et al (2011) method was used to calculate the estimate, standard error, confidence interval and P-value for the treatment difference from the results of a logistic regression analysis.|Regression, Logistic|||||48.9|2.5|0.0003
70924208|NCT05063994|141340599|SUPERIORITY|Superiority of Chronocort to Cortef with respect to the dose response after 28 weeks of randomized treatment was declared if the two-sided 95% CI for the difference in response rates between the 2 treatment arms (Chronocort minus Cortef) was wholly above zero, provided that non-inferiority of Chronocort to Cortef with respect to the biochemical response had been declared under the primary efficacy objective.|Treatment Difference|25.3|STANDARD_ERROR_OF_MEAN|11.24||0.012|TWO_SIDED|95.0|3.3|47.3||One-sided superiority. The Ge et al (2011) method was used to calculate the estimate, standard error, confidence interval and P-value for the treatment difference from the results of a logistic regression analysis.|Regression, Logistic|||||47.3|3.3|0.012
70924209|NCT05063994|141340600|SUPERIORITY|Superiority of Chronocort to Cortef (with respect to the total daily dose after 28 weeks of randomized treatment) was declared if the two-sided 95% CI for the difference in means between the 2 treatment arms (Chronocort minus Cortef) was wholly below zero, provided that non-inferiority of Chronocort to Cortef in terms of biochemical response had been declared under the primary efficacy objective, and superiority of Chronocort to Cortef in terms of dose response has been declared.|Treatment Difference|-5.8|STANDARD_ERROR_OF_MEAN|1.66||0.0005|TWO_SIDED|95.0|-9.2|-2.5||One-sided superiority.|MMRM|||||-2.5|-9.2|0.0005
70924210|NCT01180634|141340672|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.0715|TWO_SIDED|95.0|0.96|1.84||P-value is determined using a log-rank test stratified by region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|Log Rank||Hazard ratio is obtained from a Cox proportional hazards regression model adjusting for region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|||1.84|0.96|0.0715
70924211|NCT01180634|141340673|SUPERIORITY||LSMean difference|1.41||||0.0213|TWO_SIDED|95.0|0.21|2.6|||Repeared Measures Model||Estimates are determined from a repeated measures model with terms for treatment, visit, treatment\*visit, region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|||2.60|0.21|0.0213
70924212|NCT01180634|141340674|SUPERIORITY||LSMean difference|-0.63||||0.0002|TWO_SIDED|95.0|-0.95|-0.3|||Repeated Measures Model||Estimates are determined from a repeated measures model with terms for treatment, visit, treatment\*visit, region (US, non-US), age (12-18 years, \>18 years), baseline FEV1 (\<55%, \>=55%), and baseline organism log density.|||-0.30|-0.95|0.0002
70924213|NCT01180634|141340675|SUPERIORITY||LSMean difference|0.28||||0.8335|TWO_SIDED|95.0|-2.3|2.85|||Repeated Measures Model||Estimates were determined from a repeated measures model with terms for treatment, visit, treatment\*visit, region (US, non-US), age (12 to 18 years, \> 18 years), Baseline FEV1 (\<55%, ≥ 55%), and Baseline value.|||2.85|-2.30|0.8335
70924214|NCT01180634|141340676|SUPERIORITY||LSMean difference|2.42||||0.0122|TWO_SIDED|95.0|0.53|4.31|||Repeated Measures Model|||||4.31|0.53|0.0122
70924215|NCT01180634|141340677|SUPERIORITY||Cox Proportional Hazard|0.82||||0.3|TWO_SIDED|95.0|0.6|1.12||P-value is determined using a log-rank test stratified by region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|Log Rank||Hazard ratio is obtained from a Cox proportional hazards regression model adjusting for region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|||1.12|0.60|0.3000
71001341|NCT02371980|141509998|SUPERIORITY||Least Squares Mean Difference|-2.43|STANDARD_ERROR_OF_MEAN|0.765||0.002|TWO_SIDED|95.0|-3.93|-0.93|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4||-0.93|-3.93|0.002
71042461|NCT00442546|141594075|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.025|STANDARD_ERROR_OF_MEAN|0.285||0.9307||95.0|-0.588|0.538|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.538|-0.588|0.9307
70924216|NCT01180634|141340678|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.867|TWO_SIDED|95.0|0.47|2.04||P-value is determined using a log-rank test stratified by region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|Log Rank||Hazard ratio is obtained from a Cox proportional hazards regression model adjusting for region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|||2.04|0.47|0.8670
70924217|NCT04419168|141340687|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.57|TWO_SIDED|95.0|-1.3|2.37|||Mixed Models Analysis|||||2.37|-1.30|.57
70924218|NCT04419168|141340688|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.79|TWO_SIDED|95.0|-0.46|0.61|||Mixed Models Analysis|||||0.61|-0.46|0.79
70924219|NCT04419168|141340689|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.75|TWO_SIDED|95.0|-1.55|1.12|||Mixed Models Analysis|||||1.12|-1.55|0.75
71001342|NCT02371980|141509998|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.761|<|0.001|TWO_SIDED|95.0|-4.49|-1.51|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4||-1.51|-4.49|<0.001
71001343|NCT02371980|141509998|SUPERIORITY||Least Squares Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.775||0.001|TWO_SIDED|95.0|-4.02|-0.98|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4||-0.98|-4.02|0.001
70924220|NCT04419168|141340690|SUPERIORITY||Mean Difference (Final Values)|0.64||||0.31|TWO_SIDED|95.0|-0.6|1.87|||Mixed Models Analysis|||||1.87|-0.60|0.31
71042462|NCT00442546|141594075|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.439||0.2682||95.0|-1.364|0.385|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.385|-1.364|0.2682
70924221|NCT04419168|141340691|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.91|TWO_SIDED|95.0|-1.77|1.99|||Mixed Models Analysis|||These results correspond to ASCQ-Me Social Functioning Impact only.||1.99|-1.77|0.91
70924222|NCT04419168|141340691|SUPERIORITY||Mean Difference (Final Values)|1.72||||0.05|TWO_SIDED|95.0|-0.03|3.46|||Mixed Models Analysis|||These results correspond to ASCQ-Me Emotional Impact only.||3.46|-0.03|0.05
70924223|NCT04419168|141340692|SUPERIORITY||Mean Difference (Final Values)|1.13||||0.12|TWO_SIDED|95.0|-0.31|2.56|||Mixed Models Analysis|||||2.56|-0.31|0.12
70924224|NCT04419168|141340693|SUPERIORITY||Mean Difference (Final Values)|-0.0024||||0.91|TWO_SIDED|95.0|-0.0443|0.0395|||Mixed Models Analysis|||||0.0395|-0.0443|0.91
70924225|NCT04419168|141340694|SUPERIORITY||Mean Difference (Final Values)|0.43||||0.68|TWO_SIDED|95.0|-1.61|2.48|||Mixed Models Analysis|||||2.48|-1.61|0.68
70924226|NCT04419168|141340695|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.75|TWO_SIDED|95.0|-0.46|0.63|||Mixed Models Analysis|||||0.63|-0.46|0.75
70924227|NCT04419168|141340696|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.14|TWO_SIDED|95.0|-2.56|0.35|||Mixed Models Analysis|||||0.35|-2.56|0.14
71001344|NCT02371980|141509998|SUPERIORITY||Least Squares Mean Difference|-2.95|STANDARD_ERROR_OF_MEAN|0.924||0.001|TWO_SIDED|95.0|-4.76|-1.13|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8||-1.13|-4.76|0.001
71001345|NCT02371980|141509998|SUPERIORITY||Least Squares Mean Difference|-3.84|STANDARD_ERROR_OF_MEAN|0.919|<|0.001|TWO_SIDED|95.0|-5.64|-2.03|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8||-2.03|-5.64|<0.001
71001346|NCT02371980|141509998|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.939||0.001|TWO_SIDED|95.0|-4.84|-1.16|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8||-1.16|-4.84|0.001
71001347|NCT02371980|141509998|SUPERIORITY||Least Squares Mean Difference|-2.92|STANDARD_ERROR_OF_MEAN|0.938||0.002|TWO_SIDED|95.0|-4.76|-1.08|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12||-1.08|-4.76|0.002
71001348|NCT02371980|141509998|SUPERIORITY||Least Squares Mean Difference|-4.51|STANDARD_ERROR_OF_MEAN|0.934|<|0.001|TWO_SIDED|95.0|-6.34|-2.68|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12||-2.68|-6.34|<0.001
71001349|NCT02371980|141509998|SUPERIORITY||Least Squares Mean Difference|-3.64|STANDARD_ERROR_OF_MEAN|0.949|<|0.001|TWO_SIDED|95.0|-5.5|-1.78|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12||-1.78|-5.50|<0.001
71001350|NCT02371980|141509998|SUPERIORITY||Least Squares Mean Difference|-2.04|STANDARD_ERROR_OF_MEAN|0.957||0.033|TWO_SIDED|95.0|-3.92|-0.16|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16||-0.16|-3.92|0.033
71001351|NCT02371980|141509998|SUPERIORITY||Least Squares Mean Difference|-3.69|STANDARD_ERROR_OF_MEAN|0.952|<|0.001|TWO_SIDED|95.0|-5.55|-1.82|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16||-1.82|-5.55|<0.001
71001352|NCT02371980|141509998|SUPERIORITY||Least Squares Mean Difference|-2.63|STANDARD_ERROR_OF_MEAN|0.967||0.007|TWO_SIDED|95.0|-4.52|-0.73|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16||-0.73|-4.52|0.007
71001353|NCT02371980|141509998|SUPERIORITY||Least Squares Mean Difference|-2.61|STANDARD_ERROR_OF_MEAN|0.912||0.004|TWO_SIDED|95.0|-4.4|-0.82|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20||-0.82|-4.40|0.004
71001354|NCT02371980|141509998|SUPERIORITY||Least Squares Mean Difference|-4.09|STANDARD_ERROR_OF_MEAN|0.906|<|0.001|TWO_SIDED|95.0|-5.86|-2.31|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20||-2.31|-5.86|<0.001
71001355|NCT02371980|141509998|SUPERIORITY||Least Squares Mean Difference|-2.76|STANDARD_ERROR_OF_MEAN|0.921||0.003|TWO_SIDED|95.0|-4.57|-0.96|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20||-0.96|-4.57|0.003
71001356|NCT02371980|141509998|SUPERIORITY||Least Squares Mean Difference|-1.92|STANDARD_ERROR_OF_MEAN|1.008||0.057|TWO_SIDED|95.0|-3.89|0.06|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24||0.06|-3.89|0.057
70924228|NCT04419168|141340697|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.75|TWO_SIDED|95.0|-1.69|1.21|||Mixed Models Analysis|||||1.21|-1.69|0.75
71001357|NCT02371980|141509998|SUPERIORITY||Least Squares Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|0.997|<|0.001|TWO_SIDED|95.0|-5.46|-1.55|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24||-1.55|-5.46|<0.001
71001358|NCT02371980|141509998|SUPERIORITY||Least Squares Mean Difference|-2.53|STANDARD_ERROR_OF_MEAN|1.011||0.012|TWO_SIDED|95.0|-4.51|-0.55|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24||-0.55|-4.51|0.012
71042463|NCT00442546|141594075|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.294|STANDARD_ERROR_OF_MEAN|0.413||0.4784||95.0|-1.116|0.528|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.528|-1.116|0.4784
71042464|NCT00442546|141594075|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.661|STANDARD_ERROR_OF_MEAN|0.298||0.0255||95.0|0.084|1.239|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.239|0.084|0.0255
71001359|NCT02371980|141509998|SUPERIORITY||Least Squares Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.012||0.061|TWO_SIDED|95.0|-3.88|0.09|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28||0.09|-3.88|0.061
71001360|NCT02371980|141509998|SUPERIORITY||Least Squares Mean Difference|-2.36|STANDARD_ERROR_OF_MEAN|0.997||0.018|TWO_SIDED|95.0|-4.31|-0.4|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28||-0.40|-4.31|0.018
71001361|NCT02371980|141509998|SUPERIORITY||Least Squares Mean Difference|-1.88|STANDARD_ERROR_OF_MEAN|1.015||0.065|TWO_SIDED|95.0|-3.87|0.12|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28||0.12|-3.87|0.065
71001362|NCT02371980|141509998|SUPERIORITY||MMRM Model|-3.09|STANDARD_ERROR_OF_MEAN|1.136||0.007|TWO_SIDED|95.0|-5.31|-0.86|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32||-0.86|-5.31|0.007
71001363|NCT02371980|141509998|SUPERIORITY||Least Squares Mean Difference|-3.97|STANDARD_ERROR_OF_MEAN|1.122|<|0.001|TWO_SIDED|95.0|-6.16|-1.77|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32||-1.77|-6.16|<0.001
71001364|NCT02371980|141509998|SUPERIORITY||Least Squares Mean Difference|-3.58|STANDARD_ERROR_OF_MEAN|1.143||0.002|TWO_SIDED|95.0|-5.82|-1.34|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32||-1.34|-5.82|0.002
71001365|NCT02371980|141509999|SUPERIORITY||Least Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.085||0.732|TWO_SIDED|95.0|-0.2|0.14|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2||0.14|-0.20|0.732
71042465|NCT00442546|141594075|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.448|STANDARD_ERROR_OF_MEAN|0.314||0.1591||95.0|-0.18|1.076|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.076|-0.180|0.1591
71042466|NCT00442546|141594076|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.786|STANDARD_ERROR_OF_MEAN|0.372||0.0359||95.0|-1.52|-0.052|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||-0.052|-1.520|0.0359
71042467|NCT00442546|141594076|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.907|STANDARD_ERROR_OF_MEAN|0.374||0.0161||95.0|-1.644|-0.17|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||-0.170|-1.644|0.0161
71001366|NCT02371980|141509999|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.085||0.273|TWO_SIDED|95.0|-0.26|0.07|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2||0.07|-0.26|0.273
71001367|NCT02371980|141509999|SUPERIORITY||Least Squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.085||0.361|TWO_SIDED|95.0|-0.24|0.09|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2||0.09|-0.24|0.361
71001368|NCT02371980|141509999|SUPERIORITY||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.099||0.004|TWO_SIDED|95.0|-0.48|-0.09|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4||-0.09|-0.48|0.004
71001369|NCT02371980|141509999|SUPERIORITY||Least Squares Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.099||0.002|TWO_SIDED|95.0|-0.5|-0.12|||Least Squares Mean Difference|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4||-0.12|-0.50|0.002
71001370|NCT02371980|141509999|SUPERIORITY||Least Squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.55|-0.16|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4||-0.16|-0.55|<0.001
71001371|NCT02371980|141509999|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.121||0.014|TWO_SIDED|95.0|-0.54|-0.06|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8||-0.06|-0.54|0.014
71001372|NCT02371980|141509999|SUPERIORITY||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.121||0.001|TWO_SIDED|95.0|-0.63|-0.16|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8||-0.16|-0.63|0.001
71001373|NCT02371980|141509999|SUPERIORITY||Least Squares Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.123||0.002|TWO_SIDED|95.0|-0.62|-0.14|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8||-0.14|-0.62|0.002
71001374|NCT02371980|141509999|SUPERIORITY||Least Squares Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.122||0.025|TWO_SIDED|95.0|-0.51|-0.03|||Least Squares Mean Difference|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12||-0.03|-0.51|0.025
71001375|NCT02371980|141509999|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.122|<|0.001|TWO_SIDED|95.0|-0.74|-0.26|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12||-0.26|-0.74|<0.001
71001376|NCT02371980|141509999|SUPERIORITY||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.124||0.002|TWO_SIDED|95.0|-0.63|-0.15|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12||-0.15|-0.63|0.002
71001377|NCT02371980|141509999|SUPERIORITY||Least Squares Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.123||0.333|TWO_SIDED|95.0|-0.36|0.12|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16||0.12|-0.36|0.333
71001378|NCT02371980|141509999|SUPERIORITY||Least Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.122||0.002|TWO_SIDED|95.0|-0.61|-0.13|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16||-0.13|-0.61|0.002
70924229|NCT04419168|141340698|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.49|TWO_SIDED|95.0|-1.3|2.71|||Mixed Models Analysis|||These results correspond to ASCQ-Me Social Functioning Impact only.||2.71|-1.30|0.49
71001379|NCT02371980|141509999|SUPERIORITY||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.124||0.023|TWO_SIDED|95.0|-0.53|-0.04|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16||-0.04|-0.53|0.023
71001380|NCT02371980|141509999|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.121||0.092|TWO_SIDED|95.0|-0.44|0.03|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20||0.03|-0.44|0.092
71001381|NCT02371980|141509999|SUPERIORITY||Least Squares Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.121|<|0.001|TWO_SIDED|95.0|-0.67|-0.2|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20||-0.20|-0.67|<0.001
71001382|NCT02371980|141509999|SUPERIORITY||Least Squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.122||0.008|TWO_SIDED|95.0|-0.57|-0.09|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20||-0.09|-0.57|0.008
71001383|NCT02371980|141509999|SUPERIORITY||Least Squares Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.135||0.248|TWO_SIDED|95.0|-0.42|0.11|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24||0.11|-0.42|0.248
71001384|NCT02371980|141509999|SUPERIORITY||Least Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.133||0.006|TWO_SIDED|95.0|-0.63|-0.1|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24||-0.10|-0.63|0.006
71001385|NCT02371980|141509999|SUPERIORITY||Least Squares Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.135||0.087|TWO_SIDED|95.0|-0.5|0.03|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24||0.03|-0.50|0.087
70924230|NCT04419168|141340698|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.037|TWO_SIDED|95.0|0.12|3.88|||Mixed Models Analysis|||These results correspond to ASCQ-Me Emotional Impact only.||3.88|0.12|0.037
71001386|NCT02371980|141509999|SUPERIORITY||Least Squares Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.131||0.362|TWO_SIDED|95.0|-0.38|0.14|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28||0.14|-0.38|0.362
71042468|NCT00442546|141594076|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.105|STANDARD_ERROR_OF_MEAN|0.319||0.7416||95.0|-0.733|0.523|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.523|-0.733|0.7416
71042469|NCT00442546|141594076|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.301|STANDARD_ERROR_OF_MEAN|0.324||0.3527||95.0|-0.939|0.336|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.336|-0.939|0.3527
70924231|NCT04419168|141340699|SUPERIORITY||Mean Difference (Final Values)|2.13||||0.008|TWO_SIDED|95.0|0.56|3.71|||Mixed Models Analysis|||||3.71|0.56|0.008
70924232|NCT04419168|141340700|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.56|TWO_SIDED|95.0|-1.51|0.82|||Mixed Models Analysis|||||0.82|-1.51|0.56
71001387|NCT02371980|141509999|SUPERIORITY||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.129||0.251|TWO_SIDED|95.0|-0.4|0.1|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28||0.10|-0.40|0.251
71042470|NCT00442546|141594076|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.184|STANDARD_ERROR_OF_MEAN|0.3||0.5419||95.0|-0.776|0.409|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.409|-0.776|0.5419
70924233|NCT04419168|141340701|SUPERIORITY||Mean Difference (Final Values)|-0.0013||||0.95|TWO_SIDED|95.0|-0.0464|0.0437|||Mixed Models Analysis|||||0.0437|-0.0464|0.95
70924234|NCT04419168|141340702|SUPERIORITY||Incidence Rate Ratio|1.11||||0.49|TWO_SIDED|95.0|0.83|1.48|||Negative Binomial Regression|Adjustments were made for clinic site, baseline depression (high vs low), and corresponding health care use in the 12 months prior to study entry.||||1.48|0.83|0.49
71001388|NCT02371980|141509999|SUPERIORITY||Least Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.131||0.391|TWO_SIDED|95.0|-0.37|0.14|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28||0.14|-0.37|0.391
71001389|NCT02371980|141509999|SUPERIORITY||Least Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.141||0.209|TWO_SIDED|95.0|-0.45|0.1|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32||0.10|-0.45|0.209
71001390|NCT02371980|141509999|SUPERIORITY||Least Squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.139||0.018|TWO_SIDED|95.0|-0.6|-0.06|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32||-0.06|-0.60|0.018
71001391|NCT02371980|141509999|SUPERIORITY||Least Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.141||0.009|TWO_SIDED|95.0|-0.65|-0.09|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32||-0.09|-0.65|0.009
71001392|NCT02371980|141510001|SUPERIORITY||Hazard Ratio (HR)|0.481||||0.002|TWO_SIDED|95.0|0.302|0.766||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 5mg Vs Double-blind Placebo||0.766|0.302|0.002
71001393|NCT02371980|141510001|SUPERIORITY||Hazard Ratio (HR)|0.455|||<|0.001|TWO_SIDED|95.0|0.286|0.725||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 10 mg Vs Double-blind Placebo||0.725|0.286|<0.001
71001394|NCT02371980|141510001|SUPERIORITY||Hazard Ratio (HR)|0.484||||0.002|TWO_SIDED|95.0|0.304|0.771||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 20 mg Vs Double-blind Placebo||0.771|0.304|0.002
71001395|NCT01731990|141510002|SUPERIORITY_OR_OTHER_LEGACY||Treatment effect for ratio to placebo|1.06||||0.284|TWO_SIDED|90.0|0.97|1.15|||Mixed Models Analysis|||||1.15|0.97|0.284
71001396|NCT01280812|141510006|SUPERIORITY||Median Difference (Net)|1100.0|STANDARD_DEVIATION|3000.0|||TWO_SIDED|95.0|||||Mixed Models Analysis|Two-sided P values less than .05 were considered statistically significant.||Intent to treat analysis||||
71001397|NCT02279160|141510065|SUPERIORITY||Multiple imputation|0.742||||0.022|TWO_SIDED|95.0|0.575|0.958|||ANCOVA|||||0.958|0.575|0.0220
71001398|NCT02279160|141510066|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.9002|TWO_SIDED|95.0|-28.0|30.0|||Stratified Wilcoxon|||||30.0|-28.0|0.9002
71001399|NCT02853123|141510067|SUPERIORITY||Mean Difference (Final Values)|-0.357|STANDARD_ERROR_OF_MEAN|0.153||0.0217|TWO_SIDED|95.0|-0.661|-0.053|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|The adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||-0.053|-0.661|0.0217
71001400|NCT02853123|141510068|SUPERIORITY||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|0.106|0.265|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|IC measured prior to exercise, the adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.265|0.106|<.0001
71001401|NCT02853123|141510069|SUPERIORITY||Mean Difference (Final Values)|0.066|STANDARD_ERROR_OF_MEAN|0.038||0.0852|TWO_SIDED|95.0|-0.009|0.141|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|IC measured end of exercise, the adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.141|-0.009|0.0852
70924235|NCT04419168|141340703|SUPERIORITY||Incidence Rate Ratio|1.43||||0.1|TWO_SIDED|95.0|0.93|2.18|||Negative Binomial Regression|Adjustments were made for clinic site, baseline depression (high vs low), and corresponding health care use in the 12 months prior to study entry.||||2.18|0.93|0.10
71001402|NCT02853123|141510070|SUPERIORITY||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.117|0.194|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|The adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.194|0.117|<.0001
71042471|NCT00442546|141594076|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.026|STANDARD_ERROR_OF_MEAN|0.305||0.9333||95.0|-0.628|0.577|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.577|-0.628|0.9333
71042472|NCT00442546|141594076|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.354|STANDARD_ERROR_OF_MEAN|0.24||0.142||95.0|-0.827|0.12|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.120|-0.827|0.1420
71042473|NCT00442546|141594076|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.245||0.829||95.0|-0.535|0.429|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.429|-0.535|0.8290
71042474|NCT00442546|141594076|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.111|STANDARD_ERROR_OF_MEAN|0.441||0.0138||95.0|-1.989|-0.233|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||-0.233|-1.989|0.0138
70924236|NCT04419168|141340704|SUPERIORITY||Incidence Rate Ratio|1.31||||0.22|TWO_SIDED|95.0|0.85|2.03|||Negative Binomial Regression|Adjustments were made for clinic site, baseline depression (high vs low), and corresponding health care use in the 12 months prior to study entry.||||2.03|0.85|0.22
70924237|NCT04490915|141340705|SUPERIORITY||LS Mean Difference|-17.022|STANDARD_ERROR_OF_MEAN|3.433|<|0.0001|TWO_SIDED|95.0|-23.802|-10.243|||ANCOVA||LS Mean Difference of Crinecerfont - Placebo|||-10.243|-23.802|<0.0001
71001403|NCT02853123|141510071|SUPERIORITY||Mean Difference (Final Values)|0.201|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.134|0.267|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|The adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.267|0.134|<.0001
71001404|NCT02853123|141510072|SUPERIORITY||Mean Difference (Final Values)|-0.108|STANDARD_ERROR_OF_MEAN|0.096||0.2645|TWO_SIDED|95.0|-0.3|0.083|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|1 min, the adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.083|-0.300|0.2645
71001405|NCT02853123|141510072|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.107||0.0267|TWO_SIDED|95.0|-0.452|-0.028|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|2 min, the adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||-0.028|-0.452|0.0267
71001406|NCT02853123|141510072|SUPERIORITY||Mean Difference (Final Values)|-0.318|STANDARD_ERROR_OF_MEAN|0.14||0.0258|TWO_SIDED|95.0|-0.596|-0.039|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|2.5 min, the adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||-0.039|-0.596|0.0258
71001407|NCT02853123|141510073|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.12||0.8025|TWO_SIDED|95.0|-0.268|0.208|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|The adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.208|-0.268|0.8025
71001408|NCT02853123|141510074|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.099||0.3634|TWO_SIDED|95.0|-0.106|0.286|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|The adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.286|-0.106|0.3634
71001409|NCT05516134|141510087|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||baseline vs. treatment, paired sample t-test||||<0.01
71001410|NCT05516134|141510088|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<.01
71001411|NCT05516134|141510089|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<.01
71001412|NCT05516134|141510090|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||.03
71001413|NCT05516134|141510091|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<.01
71001414|NCT05516134|141510092|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||.11
71001415|NCT05516134|141510093|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<.01
71001416|NCT05516134|141510094|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
71001417|NCT01094808|141510169|SUPERIORITY_OR_OTHER||mean value for 200 mg Pregabalin|33.391|STANDARD_DEVIATION|22.106||0.14||95.0||||P-value not adjusted for multiple comparisons; alpha level of 0.05 used|ANCOVA||A confidence interval was not calculated|ANCOVA for overall treatment effects||||0.14
70924238|NCT05009251|141340717|SUPERIORITY|||||||0.054|||||||Regression, Linear|||This analysis compared groups that were informed they were high risk (High Risk Only, High Risk Based on Medical Records, High Risk Based on Algorithm) to Reminder Control patients who were sent messages that did not disclose their risk status. Null hypothesis: messages that inform patients they are high risk do not increase flu vaccination rate vs. messages that do not disclose risk status; Alternative hypothesis: messages that inform patients they are high risk increase flu vaccination rate.||||.054
71001418|NCT01094808|141510170|SUPERIORITY_OR_OTHER||mean value for 200 mg Pregabalin|35.301|STANDARD_DEVIATION|22.295||0.12||95.0||||P-value not adjusted for multiple comparisons; alpha level of 0.05 used|ANCOVA||A confidence interval was not calculated|ANCOVA for overall treatment effects||||0.12
71001419|NCT01224106|141510179|SUPERIORITY||Effect Size|-0.044||||0.6744|TWO_SIDED|95.0|-0.248|0.161|||Mixed Models Analysis|||||0.161|-0.248|0.6744
71001420|NCT01224106|141510179|SUPERIORITY||Effect Size|-0.085||||0.4494|TWO_SIDED|95.0|-0.304|0.135|||Mixed Models Analysis|||||0.135|-0.304|0.4494
71042475|NCT00442546|141594076|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.503|STANDARD_ERROR_OF_MEAN|0.416||0.23||95.0|-1.332|0.325|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.325|-1.332|0.2300
71042476|NCT00442546|141594076|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.268||0.5151||95.0|-0.36|0.711|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||0.711|-0.360|0.5151
70924239|NCT05009251|141340717|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||This analysis compared groups that were informed they were high risk (High Risk Only, High Risk Based on Medical Records, High Risk Based on Algorithm) to No-Contact Control patients who were not sent messages. Null hypothesis: messages that inform patients they are high risk do not increase flu vaccination rate relative to no messages; Alternative hypothesis: messages that inform patients they are high risk increase flu vaccination rate.||||<.001
70924240|NCT05009251|141340717|SUPERIORITY|||||||0.24|||||||Regression, Linear|||This analysis compared groups who received messages including risk reasons (High Risk Based on Medical Records, High Risk Based on Algorithm) to messages that mentioned patients' risk status but do not include reasons (High Risk Only). Null hypothesis: messages that include risk reasons do not increase flu vaccination rate relative to high-risk messages that do not include risk reasons; Alternative hypothesis: messages including risk reasons are more effective at increasing vaccination rates.||||.240
70924241|NCT05009251|141340717|SUPERIORITY|||||||0.047|||||||Regression, Linear|||Null hypothesis: flu-shot messages that do not mention high-risk status do not increase vaccination relative to no messages; Alternative hypothesis: flu shot messages that do not mention high-risk status increase flu shots relative to no messages.||||.047
71001421|NCT01224106|141510181|SUPERIORITY||Effect Size|0.035||||0.7458|TWO_SIDED|95.0|-0.179|0.25|||Mixed Models Analysis|||||0.250|-0.179|0.7458
71001422|NCT01224106|141510181|SUPERIORITY||Effect Size|0.042||||0.723|TWO_SIDED|95.0|-0.191|0.275|||Mixed Models Analysis|||||0.275|-0.191|0.723
71001423|NCT01224106|141510185|SUPERIORITY||Effect Size|-0.191||||0.0825|TWO_SIDED|95.0|-0.407|0.025|||Mixed Models Analysis|||||0.025|-0.407|0.0825
71001424|NCT01224106|141510185|SUPERIORITY||Effect Size|0.043||||0.7171|TWO_SIDED|95.0|-0.19|0.276|||Mixed Models Analysis|||||0.276|-0.19|0.7171
71001425|NCT01224106|141510188|SUPERIORITY|||||||0.9734|||||||Mixed Models Analysis|||"Statistical analysis of the Abeta 1-42 CSF biomarker between Placebo (Parts 1 and 2) and Gantenerumab 105 mg (Parts 1 and 2) treatment arms at Week 104."||||0.9734
71001426|NCT01224106|141510188|SUPERIORITY|||||||0.0629|||||||Mixed Models Analysis|||"Statistical analysis of the Abeta 1-42 CSF biomarker between Placebo (Parts 1 and 2) and Gantenerumab 225 mg (Parts 1 and 2) treatment arms at Week 104."||||0.0629
71001427|NCT01224106|141510188|SUPERIORITY|||||||0.0084|||||||Mixed Models Analysis|||"Statistical analysis of the p-tau CSF biomarker between Placebo (Parts 1 and 2) and Gantenerumab 105 mg (Parts 1 and 2) treatment arms at Week 104."||||0.0084
71001428|NCT01224106|141510188|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|||"Statistical analysis of the p-tau CSF biomarker between Placebo (Parts 1 and 2) and Gantenerumab 225 mg (Parts 1 and 2) treatment arms at Week 104."||||0.0003
71001429|NCT01224106|141510188|SUPERIORITY|||||||0.0903|||||||Mixed Models Analysis|||"Statistical analysis of the t-tau CSF biomarker between Placebo (Parts 1 and 2) and Gantenerumab 105 mg (Parts 1 and 2) treatment arms at Week 104."||||0.0903
71001430|NCT01224106|141510188|SUPERIORITY|||||||0.0434|||||||Mixed Models Analysis|||"Statistical analysis of the t-tau CSF biomarker between Placebo (Parts 1 and 2) and Gantenerumab 225 mg (Parts 1 and 2) treatment arms at Week 104."||||0.0434
71001431|NCT00446797|141510207|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To conclude non inferiority, the lower bound of the 2-sided 95% confidence interval of the difference in change scores between the 2 treatment groups (nsNSAIDs - celecoxib) must be greater than -10 mm.|Mean Difference (Final Values)|3.39|STANDARD_ERROR_OF_MEAN|2.11||||95.0|-0.76|7.55|||ANCOVA|Terms for treatment, country (fixed), and the baseline pain VAS score|Direction: nsNSAIDs minus celecoxib|Least squares mean||7.55|-0.76|
71042477|NCT00442546|141594076|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.433|STANDARD_ERROR_OF_MEAN|0.295||0.146||95.0|-0.155|1.022|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.022|-0.155|0.1460
70924242|NCT05009251|141340717|SUPERIORITY|||||||0.781||||||Pairwise comparisons between high-risk messages (Analyses 5, 6 and 7) were analyzed in the same regression. Reported p-values were adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: High Risk Only and High Risk Based on Medical Records messages are equally effective at promoting flu vaccinations; Alternative hypothesis: there is a difference in effectiveness between High Risk Only and High Risk Based on Medical Records.||||.781
71001432|NCT00446797|141510208|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|2.02||||95.0|-0.89|7.08|||ANCOVA|Terms for treatment, country (fixed) and the baseline pain VAS score|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||7.08|-0.89|
71001433|NCT00446797|141510208|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.46|STANDARD_ERROR_OF_MEAN|2.04||||95.0|-0.55|7.48|||ANCOVA|Terms for treatment, country (fixed) and the baseline pain VAS score|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||7.48|-0.55|
71001434|NCT00446797|141510208|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.76|STANDARD_ERROR_OF_MEAN|1.86||||95.0|-0.91|6.42|||ANCOVA|Terms for treatment, country (fixed) and the baseline pain VAS score|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||6.42|-0.91|
71001435|NCT00446797|141510209|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1591||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Regression, Logistic|Terms for treatment and the baseline pain VAS score||Day 2||||0.1591
71001436|NCT00446797|141510209|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3995||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Regression, Logistic|Terms for treatment and the baseline pain VAS score||Day 3||||0.3995
71001437|NCT00446797|141510209|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6805||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Regression, Logistic|Terms for treatment and the baseline pain VAS score||Day 7||||0.6805
71001438|NCT00446797|141510210|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2411||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 2||||0.2411
71001439|NCT00446797|141510210|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1163||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 3||||0.1163
71001440|NCT00446797|141510210|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 7||||0.0440
71001441|NCT00446797|141510211|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7223||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|"Controlled for country~Test of row mean score differences based on modified ridits (standardizing the mid-rank)"||Day 3||||0.7223
71001442|NCT00446797|141510211|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0541||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|"Controlled for country~Test of row mean score differences based on modified ridits (standardizing the mid-rank)"||Day 7||||0.0541
71001443|NCT00446797|141510212|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|"Controlled for country~Test of row mean score differences based on modified ridits (standardizing the mid-rank)"||Day 2||||0.2900
71001444|NCT00446797|141510212|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0157||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|"Controlled for country~Test of row mean score differences based on modified ridits (standardizing the mid-rank)"||Day 3||||0.0157
71001445|NCT00446797|141510212|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1206||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|"Controlled for country~Test of row mean score differences based on modified ridits (standardizing the mid-rank)"||Day 7||||0.1206
71001446|NCT00446797|141510213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0846||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 2||||0.0846
71001447|NCT00446797|141510213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3041||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 3||||0.3041
71001448|NCT00446797|141510213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1216||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 7||||0.1216
71001449|NCT00446797|141510214|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.24||0.395||95.0|-0.33|0.62||Overall p-value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.62|-0.33|0.395
71001450|NCT00446797|141510214|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.22||0.004||95.0|0.18|1.04||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||1.04|0.18|0.004
71001451|NCT00446797|141510214|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.22||0.122||95.0|-0.08|0.77||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.77|-0.08|0.122
71001452|NCT00446797|141510215|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.21||0.604||95.0|-0.32|0.49||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.49|-0.32|0.604
71001453|NCT00446797|141510215|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28|STANDARD_DEVIATION|0.18||0.124||95.0|-0.07|0.63||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.63|-0.07|0.124
71001454|NCT00446797|141510215|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.15||0.062||95.0|0.03|0.61||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.61|0.03|0.062
71001455|NCT00446797|141510216|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.21||0.705||95.0|-0.36|0.47||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.47|-0.36|0.705
71001456|NCT00446797|141510216|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.19||0.064||95.0|-0.01|0.73||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.73|-0.01|0.064
71001457|NCT00446797|141510216|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.17||0.074||95.0|-0.01|0.68||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.68|-0.01|0.074
71001458|NCT00446797|141510217|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.24||0.017||95.0|0.11|1.05||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||1.05|0.11|0.017
71042478|NCT00442546|141594077|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.258|STANDARD_ERROR_OF_MEAN|0.463||0.5786||95.0|-1.17|0.655|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.655|-1.170|0.5786
71042479|NCT00442546|141594077|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.025|STANDARD_ERROR_OF_MEAN|0.467||0.957||95.0|-0.895|0.946|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.946|-0.895|0.9570
71042480|NCT00442546|141594077|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.434||0.986||95.0|-0.862|0.847|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.847|-0.862|0.9860
71042481|NCT00442546|141594077|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.151|STANDARD_ERROR_OF_MEAN|0.442||0.7336||95.0|-1.021|0.72|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.720|-1.021|0.7336
71001459|NCT00446797|141510217|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.2||0.108||95.0|-0.05|0.74||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.74|-0.05|0.108
71001460|NCT00446797|141510217|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.17||0.117||95.0|-0.01|0.66||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.66|-0.01|0.117
71001461|NCT00446797|141510218|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.2||0.229||95.0|-0.17|0.6||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.60|-0.17|0.229
70924243|NCT05009251|141340717|SUPERIORITY|||||||0.361||||||Pairwise comparisons between high-risk messages (Analyses 5, 6 and 7) were analyzed in the same regression. Reported p-values were adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: High Risk Only and High Risk Based on Algorithm messages are equally effective at promoting flu vaccinations; Alternative hypothesis: there is a difference in effectiveness between High Risk Only and High Risk Based on Algorithm.||||.361
71001462|NCT00446797|141510218|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.18||0.027||95.0|0.05|0.75||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.75|0.05|0.027
71001463|NCT00446797|141510218|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.16||0.07||95.0|0.01|0.65||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.65|0.01|0.070
71001464|NCT00446797|141510219|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.3||0.954||95.0|-0.64|0.53||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.53|-0.64|0.954
71001465|NCT00446797|141510219|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.31||0.172||95.0|-0.19|1.02||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||1.02|-0.19|0.172
71001466|NCT00446797|141510219|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.24||0.541||95.0|-0.3|0.62||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.62|-0.30|0.541
71001467|NCT00446797|141510220|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.34||0.924||95.0|-0.75|0.58||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.58|-0.75|0.924
71001468|NCT00446797|141510220|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.29||0.898||95.0|-0.62|0.51||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.51|-0.62|0.898
71001469|NCT00446797|141510220|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.24||0.655||95.0|-0.33|0.6||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.60|-0.33|0.655
71042482|NCT00442546|141594077|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.384|STANDARD_ERROR_OF_MEAN|0.365||0.2939||95.0|-0.336|1.104|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||1.104|-0.336|0.2939
71042483|NCT00442546|141594077|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.274|STANDARD_ERROR_OF_MEAN|0.372||0.4615||95.0|-0.459|1.008|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||1.008|-0.459|0.4615
71042484|NCT00442546|141594077|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.161|STANDARD_ERROR_OF_MEAN|0.347||0.6433||95.0|-0.845|0.523|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.523|-0.845|0.6433
71042485|NCT00442546|141594077|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.356||0.9466||95.0|-0.678|0.726|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.726|-0.678|0.9466
71042486|NCT00442546|141594077|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.424|STANDARD_ERROR_OF_MEAN|0.621||0.4967||95.0|-1.66|0.812|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.812|-1.660|0.4967
70924244|NCT05009251|141340717|SUPERIORITY|||||||0.77||||||Pairwise comparisons between high-risk messages (Analyses 5, 6 and 7) were analyzed in the same regression. Reported p-values were adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: High Risk Based on Medical Records and High Risk Based on Algorithm messages are equally effective at promoting flu vaccinations; Alternative hypothesis: there is a difference in effectiveness between High Risk Based on Medical Records and High Risk Based on Algorithm.||||.770
71001470|NCT00446797|141510221|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.31||0.929||95.0|-0.59|0.62||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.62|-0.59|0.929
71001471|NCT00446797|141510221|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.3||0.712||95.0|-0.5|0.71||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.71|-0.50|0.712
71001472|NCT00446797|141510221|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.24||0.993||95.0|-0.44|0.51||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.51|-0.44|0.993
71001473|NCT00446797|141510222|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_DEVIATION|0.32||0.779||95.0|-0.53|0.75||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.75|-0.53|0.779
71001474|NCT00446797|141510222|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.34||0.972||95.0|-0.69|0.65||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.65|-0.69|0.972
71001475|NCT00446797|141510222|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.27||0.844||95.0|-0.47|0.61||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.61|-0.47|0.844
71042487|NCT00442546|141594077|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.582||0.8659||95.0|-1.06|1.257|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||1.257|-1.060|0.8659
71042488|NCT00442546|141594077|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.994|STANDARD_ERROR_OF_MEAN|0.451||0.0311||95.0|0.093|1.895|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.895|0.093|0.0311
71042489|NCT00442546|141594077|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.995|STANDARD_ERROR_OF_MEAN|0.485||0.0441||95.0|0.027|1.962|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.962|0.027|0.0441
71042490|NCT00442546|141594078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.969|STANDARD_ERROR_OF_MEAN|0.439||0.0284||95.0|-1.835|-0.104|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||-0.104|-1.835|0.0284
71001476|NCT00446797|141510223|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.31||0.944||95.0|-0.63|0.6||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.60|-0.63|0.944
71001477|NCT00446797|141510223|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.26||0.654||95.0|-0.62|0.38||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.38|-0.62|0.654
71001478|NCT00446797|141510223|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.19||0.952||95.0|-0.36|0.39||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.39|-0.36|0.952
71001479|NCT00446797|141510224|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.31||0.842||95.0|-0.65|0.59||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.59|-0.65|0.842
71001480|NCT00446797|141510224|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.27||0.828||95.0|-0.57|0.49||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.49|-0.57|0.828
71042491|NCT00442546|141594078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.265|STANDARD_ERROR_OF_MEAN|0.444||0.5516||95.0|-1.141|0.611|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.611|-1.141|0.5516
71042492|NCT00442546|141594078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.38||0.479||95.0|-1.02|0.48|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.480|-1.020|0.4790
71042493|NCT00442546|141594078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.003|STANDARD_ERROR_OF_MEAN|0.39||0.9947||95.0|-0.765|0.77|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.770|-0.765|0.9947
71042494|NCT00442546|141594078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.329||0.8943||95.0|-0.605|0.692|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.692|-0.605|0.8943
71042495|NCT00442546|141594078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.336||0.9767||95.0|-0.674|0.654|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.654|-0.674|0.9767
70924245|NCT05374837|141340725|SUPERIORITY||Odds Ratio (OR)|0.9585||||0.145|TWO_SIDED|95.0|0.4276|2.1485||The a priori threshold for statistical significance is \<0.05. The p-value is for the intervention by time interaction.|Regression, Logistic||Odds of consuming a minimum acceptable diet in control group at endline.|||2.1485|0.4276|0.145
71001481|NCT00446797|141510224|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.21||0.542||95.0|-0.3|0.53||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.53|-0.30|0.542
71042496|NCT00442546|141594078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.34||0.8117||95.0|-0.59|0.752|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.752|-0.590|0.8117
71042497|NCT00442546|141594078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.125|STANDARD_ERROR_OF_MEAN|0.351||0.7216||95.0|-0.818|0.567|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.567|-0.818|0.7216
71042498|NCT00442546|141594078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.108|STANDARD_ERROR_OF_MEAN|0.592||0.8558||95.0|-1.286|1.07|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||1.070|-1.286|0.8558
71042499|NCT00442546|141594078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.422|STANDARD_ERROR_OF_MEAN|0.556||0.4501||95.0|-1.53|0.685|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.685|-1.530|0.4501
71001482|NCT00446797|141510225|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.34||0.404||95.0|-0.92|0.42||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.42|-0.92|0.404
71001483|NCT00446797|141510225|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.28||0.816||95.0|-0.53|0.58||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.58|-0.53|0.816
71042500|NCT00442546|141594078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.328|STANDARD_ERROR_OF_MEAN|0.45||0.4682||95.0|-0.57|1.227|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.227|-0.570|0.4682
71001484|NCT00446797|141510225|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.23||0.837||95.0|-0.37|0.52||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.52|-0.37|0.837
71001485|NCT00446797|141510226|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.25||0.887||95.0|-0.54|0.45||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.45|-0.54|0.887
71001486|NCT00446797|141510226|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.24||0.889||95.0|-0.43|0.51||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.51|-0.43|0.889
71001487|NCT00446797|141510226|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.2||0.738||95.0|-0.3|0.47||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.47|-0.30|0.738
71042501|NCT00442546|141594078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.307|STANDARD_ERROR_OF_MEAN|0.492||0.5347||95.0|-0.675|1.289|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.289|-0.675|0.5347
71001488|NCT02498392|141510253|SUPERIORITY||Difference of Least Square (LS) Means|-0.2|STANDARD_ERROR_OF_MEAN|1.04|=|0.416|TWO_SIDED|60.0|-1.1|0.66|||Mixed-effects Model for Repeated Measure|||||0.66|-1.10|= 0.416
71001489|NCT02498392|141510254|SUPERIORITY||Difference of Least Square (LS) Means|0.3|STANDARD_ERROR_OF_MEAN|0.88|=|0.647|TWO_SIDED|60.0|-0.41|1.07||1-sided|Mixed-effects Model for Repeated Measure|||||1.07|-0.41|= 0.647
71001490|NCT02864706|141510278|SUPERIORITY|||||||0.0043|||||||ANCOVA|Incidence of CAV at 5-7 yrs was compared between groups using Cochran-Mantel-Haenszel test with stratification according to baseline distribution||||||0.0043
71001491|NCT02864706|141510279|SUPERIORITY|||||||0.037|||||||Cochran-Mantel-Haenszel|||||||0.037
71042502|NCT00442546|141594079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.765|STANDARD_ERROR_OF_MEAN|0.407||0.0613||95.0|-1.568|0.037|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.037|-1.568|0.0613
70924246|NCT05374837|141340725|SUPERIORITY||Odds Ratio (OR)|0.9669||||0.145|TWO_SIDED|95.0|0.43|2.1742||The a priori threshold for statistical significance is \<0.05. The p-value is for the intervention by time interaction.|Regression, Logistic||Odds of consuming a minimum acceptable diet in intervention group at endline.|||2.1742|0.43|0.145
71042503|NCT00442546|141594079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.936|STANDARD_ERROR_OF_MEAN|0.409||0.023||95.0|-1.741|-0.13|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||-0.130|-1.741|0.0230
71042504|NCT00442546|141594079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.4||0.8306||95.0|-0.703|0.875|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.875|-0.703|0.8306
71001492|NCT03097133|141510317|SUPERIORITY||Difference of Least Square Means|-3.9|STANDARD_ERROR_OF_MEAN|1.39||0.006|TWO_SIDED|95.0|-6.6|-1.11|||ANCOVA|||||-1.11|-6.60|0.006
71001493|NCT04080752|141510341|SUPERIORITY||Least Square (LS) Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.897||0.2494|TWO_SIDED|80.0|-1.76|0.55|||Mixed Model for Repeated Measures (MMRM)|||||0.55|-1.76|0.2494
71001494|NCT00918346|141510395|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence limit was set to 1.5 mmHg. Equivalence was shown if the two-sided 95% confidence interval for the difference (unpreserved-preserved) lay entirely within the equivalence range (-1.5 mmHg, 1.5 mmHg). Target sample size was 34 evaluable patients (40 randomized), assuming a standard deviation of 3.0 mmHg change in IOP, a power of 80%, an intra-class correlation coefficient of 0.60 and a twosided type 1 error rate of 5%.|Mean Difference (Final Values)|0.01||||0.96||95.0|-0.46|0.49|||ANCOVA|Baseline IOP a covariate|Analysis model used IOP measurements at four timepoints (at 8, 12, 16 and 20 o'clock) on Baseline and Week 4.|H1 (the alternative hypothesis aimed to be proven): the unpreserved formulation is equivalent with the preserved formulation||0.49|-0.46|0.96
71001495|NCT00918346|141510396|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence limit was set to 1.5 mmHg. Equivalence was shown if the two-sided 95% confidence interval for the difference (unpreserved-preserved) lay entirely within the equivalence range (-1.5 mmHg, 1.5 mmHg). Target sample size was 34 evaluable patients (40 randomized), assuming a standard deviation of 3.0 mmHg change in IOP, a power of 80%, an intra-class correlation coefficient of 0.60 and a twosided type I error rate of 5%.|Median Difference (Final Values)|-0.05||||0.83||95.0|-0.52|0.42|||ANCOVA|Baseline IOP a covariate|Analysis model used IOP measurements at four timepoints (at 8, 12, 16 and 20 o'clock) on Baseline and Week 4|H1 (the alternative hypothesis aimed to be proven): the unpreserved formulation is equivalent with the preserved formulation||0.42|-0.52|0.83
71001496|NCT01095666|141510477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.0869|<|0.0001|TWO_SIDED|95.0|-0.76|-0.42||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment.|ANCOVA|||||-0.42|-0.76|<0.0001
71001497|NCT01095666|141510477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.0865|<|0.0001|TWO_SIDED|95.0|-0.79|-0.45||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment.|ANCOVA|||||-0.45|-0.79|<0.0001
71001498|NCT01095666|141510478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.1|STANDARD_ERROR_OF_MEAN|3.299|<|0.0001|TWO_SIDED|95.0|-28.6|-15.6||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||-15.6|-28.6|<0.0001
71001499|NCT01095666|141510478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.1|STANDARD_ERROR_OF_MEAN|3.271|<|0.0001|TWO_SIDED|95.0|-33.5|-20.7||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||-20.7|-33.5|<0.0001
71042505|NCT00442546|141594079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.439|STANDARD_ERROR_OF_MEAN|0.407||0.2814||95.0|-1.242|0.363|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.363|-1.242|0.2814
71042506|NCT00442546|141594079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.353||0.8637||95.0|-0.636|0.757|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.757|-0.636|0.8637
71042507|NCT00442546|141594079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.359||0.9585||95.0|-0.727|0.689|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.689|-0.727|0.9585
71042508|NCT00442546|141594079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.272|STANDARD_ERROR_OF_MEAN|0.321||0.3975||95.0|-0.906|0.361|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.361|-0.906|0.3975
71001500|NCT01095666|141510479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.3|STANDARD_ERROR_OF_MEAN|5.8758|<|0.0001|TWO_SIDED|95.0|-53.84|-30.73||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||-30.73|-53.84|<0.0001
71100726|NCT02732145|141709685|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
71001501|NCT01095666|141510479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-49.1|STANDARD_ERROR_OF_MEAN|5.7921|<|0.0001|TWO_SIDED|95.0|-60.53|-37.74||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||-37.74|-60.53|<0.0001
71001502|NCT01095666|141510480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.2765|<|0.0001|TWO_SIDED|95.0|-1.65|-0.56||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||-0.56|-1.65|<0.0001
71042509|NCT00442546|141594079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.154|STANDARD_ERROR_OF_MEAN|0.327||0.6386||95.0|-0.799|0.491|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.491|-0.799|0.6386
70924247|NCT05374837|141340726|SUPERIORITY||Odds Ratio (OR)|0.3084||||0.179|TWO_SIDED|95.0|0.1977|0.481||The a priori threshold for statistical significance is \<0.05. The p-value is for the intervention by time interaction.|Regression, Logistic|||||0.481|0.1977|0.179
71001503|NCT01095666|141510480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.82|STANDARD_ERROR_OF_MEAN|0.2747|<|0.0001|TWO_SIDED|95.0|-2.36|-1.28||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||-1.28|-2.36|<0.0001
71001504|NCT01095666|141510481|SUPERIORITY_OR_OTHER||Difference in percentage|15.4|STANDARD_ERROR_OF_MEAN|4.702||0.001|TWO_SIDED|95.0|6.2|24.7||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|Modified logistic regression|Modified logistic regression model, adjusted for baseline HbA1c||||24.7|6.2|0.0010
70924248|NCT05374837|141340726|SUPERIORITY||Odds Ratio (OR)|0.438||||0.179|TWO_SIDED|95.0|0.2983|0.6431||The a priori threshold for statistical significance is \<0.05. The p-value is for the intervention by time interaction.|Regression, Logistic|||||0.6431|0.2983|0.179
71001505|NCT01095666|141510481|SUPERIORITY_OR_OTHER||Difference in percentage|15.5|STANDARD_ERROR_OF_MEAN|4.594||0.0007|TWO_SIDED|95.0|6.5|24.5||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|Modified logistic regression|Modified logistic regression model, adjusted for baseline HbA1c||||24.5|6.5|0.0007
71001506|NCT00356057|141510507|SUPERIORITY|||||||0.437|||||||t-test, 2 sided|||||||0.437
71042510|NCT00442546|141594079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.702|STANDARD_ERROR_OF_MEAN|0.397||0.0813||95.0|-1.493|0.089|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.089|-1.493|0.0813
71001507|NCT00356057|141510507|SUPERIORITY|||||||0.405|||||||t-test, 2 sided|||||||0.405
71001508|NCT00356057|141510508|EQUIVALENCE|Complication-free rate was evaluated in an equivalence (non-inferiority) format compared to a target of 85% minus delta (10%), where delta is the clinically significant difference for establishing equivalence.||||||0.0596|||||||t-test, 1 sided|||||||0.0596
71001509|NCT00356057|141510509|EQUIVALENCE|Complication-free rate was evaluated in an equivalence (non-inferiority) format compared to a target of 85% minus delta (10%), where delta is the clinically significant difference for establishing equivalence.||||||0.0009|||||||t-test, 1 sided|||||||0.0009
71042511|NCT00442546|141594079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.378|STANDARD_ERROR_OF_MEAN|0.37||0.31||95.0|-1.114|0.358|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.358|-1.114|0.3100
71042512|NCT00442546|141594079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.831|STANDARD_ERROR_OF_MEAN|0.357||0.0231||95.0|0.118|1.545|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.545|0.118|0.0231
71001510|NCT00356057|141510512|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.030
71001511|NCT00356057|141510512|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||0.006
71001512|NCT00356057|141510516|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||||||0.005
71001513|NCT00356057|141510516|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
71001514|NCT00356057|141510517|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.020
71001515|NCT00356057|141510517|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||0.008
71001516|NCT00356057|141510518|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71001517|NCT00356057|141510518|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
71001518|NCT00356057|141510519|SUPERIORITY|||||||0.039|||||||t-test, 2 sided|||||||0.039
71001519|NCT00356057|141510519|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||0.047
71001520|NCT01451398|141510520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.57|-0.23|||Mixed Models Analysis|Change in HbA1c = Baseline HbA1c + Region + Pooled OAD Strata + Visit + Treatment + (Treatment\*Visit), using AR(1) variance/covariance structure.||||-0.23|-0.57|<0.0001
71042513|NCT00442546|141594079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.463|STANDARD_ERROR_OF_MEAN|0.388||0.2367||95.0|-0.311|1.237|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.237|-0.311|0.2367
71042514|NCT00442546|141594080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.064|STANDARD_ERROR_OF_MEAN|0.448||0.8868||95.0|-0.947|0.82|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.820|-0.947|0.8868
71042515|NCT00442546|141594080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.254|STANDARD_ERROR_OF_MEAN|0.45||0.5733||95.0|-1.142|0.634|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.634|-1.142|0.5733
71042516|NCT00442546|141594080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.128|STANDARD_ERROR_OF_MEAN|0.384||0.7385||95.0|-0.884|0.628|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.628|-0.884|0.7385
71042517|NCT00442546|141594080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.081|STANDARD_ERROR_OF_MEAN|0.39||0.8353||95.0|-0.849|0.687|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.687|-0.849|0.8353
71042518|NCT00442546|141594080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.362||0.5737||95.0|-0.51|0.918|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.918|-0.510|0.5737
71042519|NCT00442546|141594080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.335|STANDARD_ERROR_OF_MEAN|0.368||0.364||95.0|-1.06|0.391|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.391|-1.060|0.3640
71042520|NCT00442546|141594080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.262|STANDARD_ERROR_OF_MEAN|0.332||0.4315||95.0|-0.393|0.917|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.917|-0.393|0.4315
71042521|NCT00442546|141594080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.339||0.6727||95.0|-0.525|0.812|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.812|-0.525|0.6727
71042522|NCT00442546|141594080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.489|STANDARD_ERROR_OF_MEAN|0.505||0.3361||95.0|-1.496|0.517|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.517|-1.496|0.3361
70924249|NCT05374837|141340732|SUPERIORITY|||||||0.054||||||A priori threshold for statistical significance \<0.05.|Chi-squared|||||||0.054
71042523|NCT00442546|141594080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.022|STANDARD_ERROR_OF_MEAN|0.469||0.9634||95.0|-0.955|0.912|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.912|-0.955|0.9634
71042524|NCT00442546|141594080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.446|STANDARD_ERROR_OF_MEAN|0.352||0.2098||95.0|-0.257|1.15|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.150|-0.257|0.2098
71100727|NCT02732145|141709685|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Interlabial Sulci versus non-specific lesions of the Posterior Commissure in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Interlabial Sulci versus non-specific lesions of the Posterior Commissure in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
71100728|NCT02732145|141709685|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
71100729|NCT02732145|141709685|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with impaired vulvar skin.||||0.0000
70924250|NCT05374837|141340733|SUPERIORITY|||||||0.65||||||A priori threshold for statistical significance \<0.05|Chi-squared|||||||0.65
71001521|NCT01451398|141510521|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.726||||0.0005|TWO_SIDED|95.0|1.55|4.8|||Regression, Logistic|Model: Treatment + Pooled OAD Stratum + Region + Baseline HbA1c||||4.80|1.55|0.0005
71001522|NCT01451398|141510522|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.361||||0.0021|TWO_SIDED|95.0|1.7|11.17|||Regression, Logistic|Model: Treatment + Pooled OAD Stratum + Region + Baseline HbA1c||||11.17|1.70|0.0021
71001523|NCT01451398|141510523|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.42|STANDARD_ERROR_OF_MEAN|5.4||0.1698|TWO_SIDED|95.0|-18.03|3.18|||Mixed Models Analysis|"Model: FPG = Baseline FPG + Region + Pooled OAD Stratum + Visit + Treatment + (Treatment \* Visit)~Variance/Covariance Matrix is Autoregression 1"||||3.18|-18.03|0.1698
71001524|NCT01451398|141510526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|0.018|||TWO_SIDED|95.0|-0.12|-0.05|||Mixed Models Analysis|FEV1 = Baseline FEV1 + Age + Gender + Race + Height + Visit + Treatment + (Treatment\*Visit)||||-0.05|-0.12|
71001525|NCT01451398|141510529|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Negative binomial regression|Model: Treatment + Region + OAD Stratum + Exposure Time||||||<0.0001
71001526|NCT01451398|141510530|SUPERIORITY_OR_OTHER|||||||0.2024|||||||Negative Binomial Regression|Model: Treatment + Region + OAD Stratum + Exposure Time||||||0.2024
71001527|NCT01451398|141510533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.62|STANDARD_ERROR_OF_MEAN|0.365|<|0.0001|TWO_SIDED|95.0|0.9|2.34|||ANCOVA||Model: Baseline Weight + Change in HbA1c at Week 24 + Region + OAD Stratum + Treatment|||2.34|0.90|<0.0001
71001528|NCT02427100|141510537|SUPERIORITY_OR_OTHER|||||||0.18|||||||ANCOVA|||||||.18
71001529|NCT02427100|141510538|SUPERIORITY_OR_OTHER|||||||0.00036||||||The Linear Mixed Model (LMM) regression analysis (repeated measures) was adjusted for daily minutes of accelerometer wear time, gender, age, BMI, education, and meeting physical activity guidelines at baseline.|Mixed Models Analysis|A fourth root transformation of daily accelerometer-measured minutes of MVPA was used to normalize the distribution and was included in the analyses.||||||.00036
71001530|NCT02573233|141510551|SUPERIORITY|||||||0.84||||||Threshold for significance at 0.05 level|Rank ANCOVA|Rank ANCOVA model stratified by ICS dose level and region||Analysis was performed using a rank ANCOVA model stratified by ICS dose level and region.||||0.8400
71001531|NCT02573233|141510552|SUPERIORITY||LS Mean Difference|-235.02||||0.0336|TWO_SIDED|90.0|-414.19|-55.84||Threshold for significance at 0.05 level|Linear fixed-effect model|||Analysis was performed using a linear fixed-effect model with treatment, region and ICS dose level as fixed effects, and the baseline value as continuous covariate.||-55.84|-414.19|0.0336
71001532|NCT02573233|141510553|SUPERIORITY||LS mean difference|13.89||||0.4795|TWO_SIDED|90.0|-19.0|46.78||Threshold for significance at 0.05 level.|Linear fixed-effect model|||Analysis was performed using a linear fixed-effect model with treatment, region and ICS dose level as fixed effects, and the baseline value as continuous covariate.||46.78|-19.00|0.4795
71001533|NCT02573233|141510554|SUPERIORITY||LS mean difference|-18.98||||0.4494|TWO_SIDED|90.0|-60.92|22.97||Threshold for significance at 0.05 level.|Linear fixed-effect model|||Analysis was performed using a linear fixed-effect model with treatment, region and ICS dose level as fixed effects, and the baseline value as continuous covariate.||22.97|-60.92|0.4494
71001534|NCT02573233|141510555|SUPERIORITY|||||||0.6865||||||Threshold for significance at 0.05 level.|Rank ANCOVA|Rank ANCOVA model stratified by ICS dose level and region||Analysis was performed using a rank ANCOVA model stratified by ICS dose level and region.||||0.6865
71001535|NCT02573233|141510556|SUPERIORITY|||||||0.7588||||||Threshold for significance at 0.05 level|Rank ANCOVA|Rank ANCOVA model stratified by ICS dose level and region||Analysis was performed using a rank ANCOVA model stratified by ICS dose level and region.||||0.7588
71001536|NCT02573233|141510557|SUPERIORITY||LS Mean Difference|-22.4||||0.0012|TWO_SIDED|90.0|-32.9|-11.9||Threshold for significance at 0.05 level|MMRM|||Analysis was performed using a Mixed-effect Model with Repeated Measures (MRMM) with treatment, treatment-by-visit interaction, region, and ICS dose level as fixed effects, and baseline biomarker-by-visit interaction as fixed covariate, and assuming an unstructured covariance structure separately by treatment group.||-11.9|-32.9|0.0012
71001537|NCT02573233|141510558|SUPERIORITY||LS Mean Difference|-22.0||||0.0005|TWO_SIDED|90.0|-31.3|-12.8||Threshold for significance at 0.05 level|MMRM|||Analysis was performed using a Mixed-effect model with Repeated Measures (MMRM) with treatment, treatment-by-visit interaction, region, and ICS dose level as fixed effects, and baseline biomarker-by-visit interaction as fixed covariate, and assuming an unstructured covariance structure separately by treatment group.||-12.8|-31.3|0.0005
71001538|NCT00924729|141510572|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71001539|NCT02917629|141510618|SUPERIORITY||Mean Difference (Final Values)|1.0011|STANDARD_DEVIATION|0.024||0.031|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000229822 baseline and post exposure||||0.031
71001540|NCT02917629|141510618|SUPERIORITY||Mean Difference (Final Values)|-1.0217|STANDARD_DEVIATION|0.0257||0.031|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000230585 baseline and post exposure||||0.031
71001541|NCT02917629|141510618|SUPERIORITY||Mean Difference (Final Values)|-1.0098|STANDARD_DEVIATION|0.005|<|0.001|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000249245 baseline and post exposure||||<0.001
71001542|NCT02917629|141510618|SUPERIORITY||Mean Difference (Final Values)|1.0007|STANDARD_DEVIATION|0.0063|<|0.001|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000261792 baseline and post exposure||||<0.001
71001543|NCT02917629|141510619|SUPERIORITY||Mean Difference (Final Values)|1.006|STANDARD_DEVIATION|0.006||0.002|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000234806 baseline and post exposure||||0.002
71001544|NCT02917629|141510620|SUPERIORITY||Mean Difference (Final Values)|1.0013|STANDARD_DEVIATION|0.0072||0.002|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000232479 baseline and post exposure||||0.002
71001545|NCT02917629|141510620|SUPERIORITY||Mean Difference (Final Values)|1.0037|STANDARD_DEVIATION|0.0193||0.02|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000233163 baseline and post exposure||||0.020
71001546|NCT02917629|141510620|SUPERIORITY||Mean Difference (Final Values)|-1.0098|STANDARD_DEVIATION|0.005||0.001|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000249245 baseline and post-exposure||||0.001
71001547|NCT01042938|141510649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7991|STANDARD_DEVIATION|0.7606||0.0077|TWO_SIDED|95.0|-1.3693|-0.2289|||Standard pooled variances t-test|||Hypothesis: The mean RDS for curcumin group is significantly different (i.e., lower) than mean RDS of placebo group at end of radiation treatment.||-0.2289|-1.3693|0.0077
71001548|NCT01042938|141510650|SUPERIORITY_OR_OTHER|||||||0.0022||95.0|||||Fisher Exact|||Hypothesis: The presence of moist desquamation significantly differed between the curcumin group and the placebo group.||||0.0022
71001549|NCT01042938|141510651|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||ANOVA|||Hypothesis: There is a significant difference in mean redness (i.e., mean a\* number value) between the curcumin and placebo groups.||||0.145
71001550|NCT01042938|141510652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.685||||0.218|TWO_SIDED|95.0|-1.059|4.428|||ANCOVA|||Hypothesis: There is a significant difference in mean MPQ pain scores between the curcumin and placebo groups.||4.428|-1.059|0.218
71001551|NCT01042938|141510652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.152|TWO_SIDED|95.0|-0.6|3.6|||ANCOVA|||Hypothesis: There is a significant difference in mean sensory subscale pain scores between curcumin and placebo groups.||3.6|-0.6|0.152
71001552|NCT01042938|141510652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.7|TWO_SIDED|95.0|-0.7|1.1|||ANCOVA|||Hypohesis: There is a signifcant difference in affective subscale pain scores between curcumin and placebo groups.||1.1|-0.7|0.700
71001553|NCT01042938|141510652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.559|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||Hypothesis: There is a significant difference in mean perceived pain scores between curcumin and placebo groups.||0.7|-0.4|0.559
71042525|NCT00442546|141594080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.382||0.49||95.0|-0.497|1.027|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.027|-0.497|0.4900
70924251|NCT03149315|141340739|SUPERIORITY|Values for grouped data were reported as mean ± SD and were calculated using Graphpad Prism 7 software (La Jolla, CA), which was also used for generating figures and for statistical analyses. Changes in skin test area (wheal and flare) were analyzed at each time point (after 2 doses, 4 doses, etc) using Friedman tests for grouped analysis and Wilcoxon signed rank tests between pairs.|||||<|0.0001||||||The above p value reflects the statistical analysis of skin test area between baseline and 2 doses of ibrutinib.|Wilcoxon (Mann-Whitney)|Changes in skin test area at each time point were analyzed using Friedman tests for grouped analysis and Wilcoxon signed rank tests between pairs.||||||<0.0001
71042526|NCT00442546|141594081|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.546||0.9912||95.0|-1.07|1.082|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||1.082|-1.070|0.9912
70924252|NCT03149315|141340740|SUPERIORITY|Changes in BAT were analyzed at each time point (after 2 doses, 4 doses, etc) using repeated measures ANOVA for grouped analysis and paired Students t tests between pairs. A p value \< 0.05 was considered significant.|||||<|0.001||||||The above p value reflects the statistical analysis of BAT between baseline and 2 doses of ibrutinib.|ANOVA|Changes in BAT were analyzed at each time point using repeated measures ANOVA for grouped analysis and paired Students t tests between pairs.||||||<0.001
70924253|NCT02910583|141340758|SUPERIORITY||Difference in Rates|4.7||||0.1475|TWO_SIDED|95.0|-1.6|10.9||P-value is from Z test for the difference of two proportions based on Kaplan-Meier estimates with standard error of each arm computed using Greenwood's formula.|Z test||comparison: ibrutininb vs. placebo|||10.9|-1.6|0.1475
70924254|NCT02910583|141340759|SUPERIORITY||||||<|0.0001||||||One-sided P-value from asymptotic test for the binomial proportion (CRR \<= 37% vs CRR \> 37%).|asymptotic test for binomial proportion|||||||< 0.0001
71001554|NCT03136484|141510653|NON_INFERIORITY|The non-inferiority p-value was calculated as two times the one-sided p-value from a t-distributed test statistic comparing the treatment contrast with 0.3 rather than zero as in a superiority test.|Treatment difference|-0.49|||<|0.0001|TWO_SIDED|95.0|-0.65|-0.33|||ANCOVA||Semaglutide + canagliflozin placebo vs Canagliflozin + semaglutide placebo|The responses were analysed using an analysis of covariance (ANCOVA) with treatment, region and stratification factor as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomised treatment, using a regression model including region and stratification factor as categorical effects and data from baseline and all previous visits as covariates.||-0.33|-0.65|<.0001
71001555|NCT03136484|141510653|SUPERIORITY||Treatment difference|-0.49|||<|0.0001|TWO_SIDED|95.0|-0.65|-0.33|||ANCOVA||Semaglutide + canagliflozin placebo vs Canagliflozin + semaglutide placebo|The responses were analysed using an ANCOVA with treatment, region and stratification factor as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomised treatment, using a regression model including region and stratification factor as categorical effects and data from baseline and all previous visits as covariates.||-0.33|-0.65|<.0001
71001556|NCT00360685|141510714|SUPERIORITY_OR_OTHER|||||||0.06|||||||Fisher Exact|||Sample size was based on the difference in the proportion of patients in each arm who were predicted to develop severe mucositis defined as clinical grade 3 or 4 per the CTCAE. A sample-size of 42 evaluable subjects per study-arm allowed detection of an absolute difference of 30%, which corresponds to a reduction in the incidence of severe mucositis from 60% in the methotrexate arm to 30% in the MMF arm (alpha=0.05, power=0.80).||||0.06
71001557|NCT00360685|141510715|SUPERIORITY_OR_OTHER|||||||0.8|||||||K-sample tests for comparing the cumulat|||||||0.8
71001558|NCT00360685|141510716|SUPERIORITY_OR_OTHER|||||||0.58|||||||Log Rank|||||||0.58
71001559|NCT00856986|141510738|SUPERIORITY_OR_OTHER||Estimated Treatment Difference, LSMean|-0.52||||||95.0|-0.68|-0.36|||ANCOVA|||The estimated treatment difference between Detemir+Lira 1.8 and Lira 1.8 as well as 95% confidence interval and p-value were calculated by an ANCOVA model with treatment, country and previous OAD as fixed factors and baseline value as covariate. The p-value reflects a two-sided test for the null hypothesis of no difference between the two treatment groups with a significance level of 5% and with the power of 90%.||-0.36|-0.68|
71042527|NCT00442546|141594081|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.135|STANDARD_ERROR_OF_MEAN|0.554||0.8076||95.0|-1.227|0.957|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.957|-1.227|0.8076
71042528|NCT00442546|141594081|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.179|STANDARD_ERROR_OF_MEAN|0.46||0.6978||95.0|-0.727|1.085|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||1.085|-0.727|0.6978
71042529|NCT00442546|141594081|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.293|STANDARD_ERROR_OF_MEAN|0.47||0.5344||95.0|-1.219|0.634|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.634|-1.219|0.5344
71042530|NCT00442546|141594081|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.062|STANDARD_ERROR_OF_MEAN|0.384||0.8721||95.0|-0.819|0.695|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.695|-0.819|0.8721
71042531|NCT00442546|141594081|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.395|STANDARD_ERROR_OF_MEAN|0.394||0.3179||95.0|-1.173|0.383|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.383|-1.173|0.3179
71042532|NCT00442546|141594081|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.376||0.8037||95.0|-0.648|0.835|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.835|-0.648|0.8037
71042533|NCT00442546|141594081|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.39||0.7731||95.0|-0.656|0.881|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.881|-0.656|0.7731
71042534|NCT00442546|141594081|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.468|STANDARD_ERROR_OF_MEAN|0.611||0.4461||95.0|-1.684|0.748|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.748|-1.684|0.4461
70924255|NCT03205800|141340788|SUPERIORITY||||||<|0.05|||||||Wilcoxon signed rank test|||||||<0.05
70924256|NCT04083235|141340857|OTHER||Hazard Ratio (HR)|0.83||||0.04|TWO_SIDED|95.0|0.7|0.99|||Stratified log-rank test||The HR and 95% confidence interval (CI) was based on a stratified Cox proportional hazards regression model, stratified by baseline Eastern Cooperative Oncology Group (ECOG) performance status, region and liver metastases as per IWRS.|||0.99|0.70|0.04
70924257|NCT04083235|141340858|OTHER||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.58|0.83|||Stratified log-rank test||The HR and 95% CI was based on a stratified Cox proportional hazards regression model, stratified by baseline ECOG performance status, region and liver metastases as per IWRS.|||0.83|0.58|<0.0001
70924258|NCT04083235|141340859|OTHER||Odds Ratio (OR)|1.26||||0.11|TWO_SIDED|95.0|0.95|1.69|||Cochran-Mantel-Haenszel||OR, 95% CI and p-value were obtained from the Cochran-Mantel-Haenszel test adjusting by baseline ECOG performance status, region and liver metastases as per IWRS.|||1.69|0.95|0.11
71001560|NCT00856986|141510739|SUPERIORITY_OR_OTHER||Estimated Treatment Difference, LSMean|-0.41||||||95.0|-0.6|-0.21|||ANCOVA||The analysis values for intensified Lira 1.8 mg subjects were kept in the treatment group and the last observation carried forward (LOCF) method was applied.|The estimated treatment difference between Detemir+Lira 1.8 and Lira 1.8 as well as 95% confidence interval and p-value were calculated by an ANCOVA model with treatment, country and previous OAD as fixed factors and baseline value as covariate. The p-value reflects a two-sided test for the null hypothesis of no difference between the two treatment groups with a significance level of 5%.||-0.21|-0.6|
71001561|NCT00856986|141510740|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS mean|-0.51||||||95.0|-0.7|-0.31|||ANCOVA||The mean change in HbA1c from randomisation to week 52 was analysed including the values before intensification as LOCF for intensified subjects|||-0.31|-0.7|
71001562|NCT04018612|141510781|SUPERIORITY||LS Mean Difference|-21.84|STANDARD_ERROR_OF_MEAN|11.091||0.0258|ONE_SIDED|90.0||-7.53|||ANCOVA||SPID24 was analyzed using ANCOVA model with treatment group as a fixed effect and baseline (BL) Pain Intensity-Numerical Pain Relief Scale (PI-NPRS) as a covariate. The lower limit of one-sided 90% confidence interval (CI) was -∞|||-7.53||0.0258
71001563|NCT04018612|141510781|SUPERIORITY||LS Mean Difference|-25.74|STANDARD_ERROR_OF_MEAN|11.154||0.0115|ONE_SIDED|90.0||-11.35|||ANCOVA||SPID24 was analyzed using an analysis of covariance (ANCOVA) model with treatment group as a fixed effect and baseline PI-NPRS as a covariate. The lower limit of one-sided 90% CI was -∞|||-11.35||0.0115
71001564|NCT04018612|141510782|SUPERIORITY||LS Mean Difference|12.72|STANDARD_ERROR_OF_MEAN|5.267||0.0087|ONE_SIDED|90.0|5.92||||ANCOVA||TOTPAR24 was analyzed using an ANCOVA model with treatment group as a fixed effect and baseline PI-NPRS as a covariate. The upper limit of one-sided 90% CI was +∞||||5.92|0.0087
71001565|NCT04018612|141510782|SUPERIORITY||LS Mean Difference|12.14|STANDARD_ERROR_OF_MEAN|5.297||0.012|ONE_SIDED|90.0|5.31||||ANCOVA||TOTPAR24 was analyzed using an ANCOVA model with treatment group as a fixed effect and baseline PI-NPRS as a covariate. The upper limit of one-sided 90% CI was +∞||||5.31|0.0120
71001566|NCT02999191|141510808|OTHER||Ratio|89.9|STANDARD_DEVIATION|36.0|||TWO_SIDED|90.0|73.304|110.25|||ANOVA||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 1467335: Tablets, fasted (numerator) and Solution, fasted (denominator). The Standard Deviation \[SD\] is the intra-individual geometric coefficient of variation \[%\].|The statistical model used for the analysis of the endpoint was an ANOVA \[Analysis of Variance\] model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects nested within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||110.25|73.304|
71001567|NCT02999191|141510808|OTHER||Ratio|170.78|STANDARD_DEVIATION|33.9|||TWO_SIDED|90.0|139.85|208.54|||ANOVA||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 1467335: Tablets, fed (numerator) and Tablets, fasted (denominator). The parameter dispersion type \[SD\] is the intra-individual geometric coefficient of variation \[%\].|The statistical model used for the analysis of the endpoint was an ANOVA \[Analysis of Variance\] model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects nested within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||208.54|139.85|
71042535|NCT00442546|141594081|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.533|STANDARD_ERROR_OF_MEAN|0.575||0.3568||95.0|-1.679|0.612|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.612|-1.679|0.3568
70924259|NCT01007591|141340860|SUPERIORITY||Mean Difference (Final Values)|-6.02||||0.75|TWO_SIDED|95.0|-43.7|31.7|||ANOVA|Treatment comparison using an ANOVA model with age group and treatment as design variables.||||31.7|-43.7|0.75
70924260|NCT02549339|141340865|SUPERIORITY||Ratio of clearance rates|7.57||||0.001|TWO_SIDED|95.0|2.26|25.31|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.|||25.31|2.26|0.001
70924261|NCT02549339|141340866|SUPERIORITY||Ratio of clearance rates|5.9|||<|0.001|TWO_SIDED|95.0|3.3|10.54|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||10.54|3.30|<0.001
71042536|NCT00442546|141594081|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.598|STANDARD_ERROR_OF_MEAN|0.315||0.0623||95.0|-0.032|1.227|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.227|-0.032|0.0623
71042537|NCT00442546|141594081|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.343||0.3529||95.0|-0.364|1.005|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.005|-0.364|0.3529
71042538|NCT00442546|141594082|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.611|STANDARD_ERROR_OF_MEAN|0.417||0.1448||95.0|-1.434|0.212|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.212|-1.434|0.1448
71042539|NCT00442546|141594082|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.665|STANDARD_ERROR_OF_MEAN|0.42||0.1148||95.0|-1.494|0.163|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.163|-1.494|0.1148
71042540|NCT00442546|141594082|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.448|STANDARD_ERROR_OF_MEAN|0.458||0.3285||95.0|-1.35|0.454|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.454|-1.350|0.3285
71001568|NCT02999191|141510809|OTHER||Ratio|84.17|STANDARD_DEVIATION|48.8|||TWO_SIDED|90.0|64.26|110.24|||ANOVA||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 1467335: Tablets, fasted (numerator) and Solution, fasted (denominator). The parameter dispersion type \[SD\] is the intra-individual geometric coefficient of variation \[%\].|The statistical model used for the analysis of the endpoint was an ANOVA \[Analysis of Variance\] model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects nested within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||110.24|64.260|
70924262|NCT02549339|141340867|SUPERIORITY||Ratio of clearance rates|5.75|||<|0.001|TWO_SIDED|95.0|3.24|10.2|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||10.20|3.24|<0.001
71001569|NCT02999191|141510809|OTHER||Ratio|136.16|STANDARD_DEVIATION|54.8|||TWO_SIDED|90.0|99.885|185.61|||ANOVA||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 1467335: Tablets, fed (numerator) and Tablets, fasted (denominator). The parameter dispersion type \[SD\] is the intra-individual geometric coefficient of variation \[%\].|The statistical model used for the analysis of the endpoint was an ANOVA \[Analysis of Variance\] model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects nested within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||185.61|99.885|
71001570|NCT02043509|141510883|SUPERIORITY||Adjusted odds ratio|2.7|||||TWO_SIDED|95.0|0.93|9.35|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||9.35|0.93|
71001571|NCT02043509|141510884|SUPERIORITY||Adjusted odds ratio|1.03|||||TWO_SIDED|95.0|0.61|1.75|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||1.75|0.61|
71001572|NCT02043509|141510885|SUPERIORITY||Adjusted odds ratio|1.34|||||TWO_SIDED|95.0|0.79|2.31|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||2.31|0.79|
71001573|NCT02043509|141510886|SUPERIORITY||Adjusted odds ratio|1.67|||||TWO_SIDED|95.0|0.72|4.03|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||4.03|0.72|
71001574|NCT02043509|141510887|SUPERIORITY||Adjusted odds ratio|2.11|||||TWO_SIDED|95.0|0.89|5.46|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||5.46|0.89|
71001575|NCT02043509|141510888|SUPERIORITY||Adjusted odds ratio|3.16|||||TWO_SIDED|95.0|1.14|10.69|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||10.69|1.14|
71001576|NCT02043509|141510889|SUPERIORITY||Adjusted odds ratio|3.28|||||TWO_SIDED|95.0|0.9|17.36|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||17.36|0.90|
71001577|NCT02043509|141510890|SUPERIORITY|||||||0.118|||||||Mann-Whitney U-test|||||||0.118
71001578|NCT03189563|141510897|SUPERIORITY|||||||0.3656||||||p-value is from ANCOVA model adjusted for baseline motor MDS-UPDRS total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.3656
71001579|NCT03189563|141510897|SUPERIORITY|||||||0.3119||||||p-value is from ANCOVA model adjusted for baseline motor MDS-UPDRS total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.3119
71001580|NCT03189563|141510898|SUPERIORITY|||||||0.147||||||p-value is from ANCOVA model adjusted for baseline MDS-UPDRS total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.1470
71042541|NCT00442546|141594082|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.572|STANDARD_ERROR_OF_MEAN|0.466||0.2205||95.0|-1.49|0.346|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.346|-1.490|0.2205
71001581|NCT03189563|141510898|SUPERIORITY|||||||0.252||||||p-value is from ANCOVA model adjusted for baseline MDS-UPDRS total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.2520
71001582|NCT03189563|141510899|SUPERIORITY|||||||0.1528||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 1 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.1528
71001583|NCT03189563|141510899|SUPERIORITY|||||||0.6146||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 1 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.6146
71042542|NCT00442546|141594082|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.389||0.6266||95.0|-0.958|0.578|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.578|-0.958|0.6266
71001584|NCT03189563|141510900|SUPERIORITY|||||||0.5691||||||p-value is from ANCOVA model adjusted for baseline S\&E scale total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.5691
71001585|NCT03189563|141510900|SUPERIORITY|||||||0.1309||||||p-value is from ANCOVA model adjusted for baseline S\&E scale total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.1309
71001586|NCT03189563|141510901|SUPERIORITY|||||||0.7913||||||p-value is from ANCOVA model adjusted for baseline PDQ-39 summary index. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.7913
71001587|NCT03189563|141510901|SUPERIORITY|||||||0.9399||||||p-value is from ANCOVA model adjusted for baseline PDQ-39 summary index. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.9399
71001588|NCT03189563|141510902|SUPERIORITY|||||||0.4978||||||p-value is from ANCOVA model adjusted for baseline H\&Y scale total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.4978
71001589|NCT03189563|141510902|SUPERIORITY|||||||0.888||||||p-value is from ANCOVA model adjusted for baseline H\&Y scale total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.8880
71001590|NCT03189563|141510903|SUPERIORITY|||||||0.5755||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 2 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.5755
71001591|NCT03189563|141510903|SUPERIORITY|||||||0.1517||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 2 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.1517
71001592|NCT03189563|141510904|SUPERIORITY|||||||0.2095||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 3 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.2095
71001593|NCT03189563|141510904|SUPERIORITY|||||||0.6094||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 3 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.6094
71001594|NCT03189563|141510905|SUPERIORITY|||||||0.226||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 4 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.2260
71001595|NCT03189563|141510905|SUPERIORITY|||||||0.226||||||p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 4 subscale score All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.2260
71001596|NCT03189563|141510906|SUPERIORITY|||||||0.8274||||||p-value is from ANCOVA model adjusted for baseline CGI-S score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.8274
71001597|NCT03189563|141510906|SUPERIORITY|||||||0.3416||||||p-value is from ANCOVA model adjusted for baseline CGI-S score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.3416
71001598|NCT03189563|141510907|SUPERIORITY|||||||0.4052||||||P-value is from ANCOVA model. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||||||0.4052
71001599|NCT03189563|141510907|SUPERIORITY|||||||0.2643||||||P-value is from ANCOVA model. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||||||0.2643
71001600|NCT01957215|141510923|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.72||||0.0201||95.0|0.1134|1.3199||P- value was obtained from ANCOVA model with treatment and site as fixed effects and NRS Baseline value as a covariate|ANCOVA||ADJ DIFF is the Treatment difference defined as the Adjusted Mean of 0.35% Indomethacin Patches minus Adjusted Mean of Placebo Patches|||1.3199|0.1134|0.0201
71001601|NCT00937326|141511016|SUPERIORITY|||||||0.4816||||||No adjustments for covariates were made.|Fisher Exact|||Placebo versus SRT2104 0.25 g/day in number of participants with any AE.||||0.4816
71001602|NCT00937326|141511016|SUPERIORITY|||||||0.1147||||||No adjustments for covariates were made.|Fisher Exact|||Placebo versus SRT2104 0.5 g/day in number of participants with any AE.||||0.1147
71001603|NCT00937326|141511016|SUPERIORITY|||||||1||||||No adjustments for covariates were made.|Fisher Exact|||Placebo versus SRT2104 1.0 g/day in number of participants with any AE.||||1.0000
71001604|NCT00937326|141511016|SUPERIORITY|||||||0.4816||||||No adjustments for covariates were made.|Fisher Exact|||Placebo versus SRT2104 2.0 g/day in number of participants with any AE.||||0.4816
71001605|NCT00937326|141511040|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|168.4|||||TWO_SIDED|90.0|123.87|228.94|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding confidence interval (CI) were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for AUC 0-t of SRT2104 0.25 g/day.||228.94|123.87|
71001606|NCT00937326|141511040|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|110.88|||||TWO_SIDED|90.0|88.18|139.43|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI. AUC values included in the analysis were AUC 0-infinity on Day 1 and AUC 0-τ on Day 28.|Day 28 versus Day 1 for AUC 0-infinity of SRT2104 0.25 g/day.||139.43|88.18|
71001607|NCT00937326|141511040|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|133.11|||||TWO_SIDED|90.0|100.55|176.21|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for AUC 0-t of SRT2104 0.5 g/day.||176.21|100.55|
71001608|NCT00937326|141511040|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Other|94.3|||||TWO_SIDED|90.0|70.31|126.48|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI. The AUC values included in the analysis were AUC 0-infinity on Day 1 and AUC 0-τ on Day 28.|Day 28 versus Day 1 for AUC 0-infinity of SRT2104 0.5 g/day.||126.48|70.31|
71042543|NCT00442546|141594082|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.502|STANDARD_ERROR_OF_MEAN|0.397||0.2077||95.0|-1.284|0.281|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.281|-1.284|0.2077
71042544|NCT00442546|141594082|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.223|STANDARD_ERROR_OF_MEAN|0.385||0.5626||95.0|-0.982|0.536|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.536|-0.982|0.5626
71042545|NCT00442546|141594082|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.368|STANDARD_ERROR_OF_MEAN|0.394||0.3507||95.0|-1.145|0.408|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.408|-1.145|0.3507
71042546|NCT00442546|141594082|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.224|STANDARD_ERROR_OF_MEAN|0.64||0.7276||95.0|-1.498|1.05|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||1.050|-1.498|0.7276
71042547|NCT00442546|141594082|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.558|STANDARD_ERROR_OF_MEAN|0.598||0.353||95.0|-1.748|0.631|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.631|-1.748|0.3530
71042548|NCT00442546|141594082|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.186|STANDARD_ERROR_OF_MEAN|0.529||0.0283||95.0|0.13|2.242|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||2.242|0.130|0.0283
71042549|NCT00442546|141594082|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.227|STANDARD_ERROR_OF_MEAN|0.573||0.6934||95.0|-0.918|1.372|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.372|-0.918|0.6934
71042550|NCT00442546|141594083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.553|STANDARD_ERROR_OF_MEAN|0.77||0.0476||95.0|-3.089|-0.017|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours||-0.017|-3.089|0.0476
71042551|NCT00442546|141594083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.768|STANDARD_ERROR_OF_MEAN|0.764||0.0237||95.0|-3.293|-0.243|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours||-0.243|-3.293|0.0237
71042552|NCT00442546|141594083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.276|STANDARD_ERROR_OF_MEAN|0.402||0.4925||95.0|-0.516|1.069|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||1.069|-0.516|0.4925
71042553|NCT00442546|141594083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.414||0.8299||95.0|-0.727|0.905|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.905|-0.727|0.8299
71042554|NCT00442546|141594083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.038|STANDARD_ERROR_OF_MEAN|0.37||0.9185||95.0|-0.766|0.691|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.691|-0.766|0.9185
71042555|NCT00442546|141594083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.339|STANDARD_ERROR_OF_MEAN|0.371||0.3619||95.0|-1.07|0.392|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.392|-1.070|0.3619
71042556|NCT00442546|141594083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.358|STANDARD_ERROR_OF_MEAN|0.453||0.4309||95.0|-0.538|1.254|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||1.254|-0.538|0.4309
71042557|NCT00442546|141594083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.013|STANDARD_ERROR_OF_MEAN|0.459||0.9778||95.0|-0.895|0.921|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.921|-0.895|0.9778
71042558|NCT00442546|141594083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.777||0.8503||95.0|-1.411|1.706|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||1.706|-1.411|0.8503
71042559|NCT00442546|141594083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.845|STANDARD_ERROR_OF_MEAN|0.757||0.0183||95.0|-3.364|-0.326|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||-0.326|-3.364|0.0183
71001609|NCT00937326|141511040|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|141.63|||||TWO_SIDED|90.0|111.2|180.39|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for AUC 0-t of SRT2104 1.0 g/day.||180.39|111.20|
71001610|NCT00937326|141511040|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|114.46|||||TWO_SIDED|90.0|85.56|153.11|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI. The AUC values included in the analysis were AUC 0-infinity on Day 1 and AUC 0-τ on Day 28.|Day 28 versus Day 1for AUC 0-infinity of SRT2104 1.0 g/day.||153.11|85.56|
71001611|NCT00937326|141511040|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|167.09|||||TWO_SIDED|90.0|120.73|231.25|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for AUC 0-t of SRT2104 2.0 g/day.||231.25|120.73|
71001612|NCT00937326|141511040|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|117.73|||||TWO_SIDED|90.0|85.14|162.79|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI. The AUC values included in the analysis were AUC 0-infinity on Day 1 and AUC 0-τ on Day 28.|Day 28 versus Day 1 for AUC 0-infinity of SRT2104 2.0 g/day.||162.79|85.14|
71001613|NCT00937326|141511041|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|122.22|||||TWO_SIDED|90.0|86.94|171.8|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for Cmax of SRT2104 0.25 g/day.||171.80|86.94|
71001614|NCT00937326|141511041|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|94.45|||||TWO_SIDED|90.0|69.07|129.16|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for Cmax of SRT2104 0.5 g/day.||129.16|69.07|
71001615|NCT00937326|141511041|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|114.79|||||TWO_SIDED|90.0|91.54|143.95|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for Cmax of SRT2104 1.0 g/day.||143.95|91.54|
71001616|NCT00937326|141511041|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|120.3|||||TWO_SIDED|90.0|88.66|163.23|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for Cmax of SRT2104 2.0 g/day.||163.23|88.66|
71001617|NCT00937326|141511046|SUPERIORITY|||||||0.997||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 8 for FPG.||||0.997
71001618|NCT00937326|141511046|SUPERIORITY|||||||0.581||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 8 for FPG.||||0.581
71001619|NCT00937326|141511046|SUPERIORITY|||||||0.987||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 8 for FPG.||||0.987
71042560|NCT00442546|141594083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.141|STANDARD_ERROR_OF_MEAN|0.956||0.286||95.0|-3.598|1.316|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||1.316|-3.598|0.2860
71042561|NCT00442546|141594083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.71|STANDARD_ERROR_OF_MEAN|1.856||0.204||95.0|-7.479|2.06|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||2.060|-7.479|0.2040
71042562|NCT00442546|141594083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.141|STANDARD_ERROR_OF_MEAN|0.295||0.6332||95.0|-0.722|0.44|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.440|-0.722|0.6332
71042563|NCT00442546|141594083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.196|STANDARD_ERROR_OF_MEAN|0.303||0.5183||95.0|-0.402|0.794|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.794|-0.402|0.5183
71042564|NCT00442546|141594083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.146|STANDARD_ERROR_OF_MEAN|0.306||0.6341||95.0|-0.75|0.458|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.458|-0.750|0.6341
71042565|NCT00442546|141594083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.236|STANDARD_ERROR_OF_MEAN|0.32||0.4607||95.0|-0.868|0.395|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.395|-0.868|0.4607
70924263|NCT02549339|141340868|SUPERIORITY||Week 8 AK count ratio|0.3|||<|0.001|TWO_SIDED|95.0|0.25|0.35||Negative binominal regression with treatment group and pooled site as factors and log baseline count as offset variable.|Mantel Haenszel||0.018% relative to vehicle.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||0.35|0.25|<0.001
71001620|NCT00937326|141511046|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 8 for FPG.||||0.999
70924264|NCT05458011|141340886|OTHER||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|-2.66|-0.95|||ANCOVA|||||-0.95|-2.66|<0.0001
71042566|NCT00442546|141594083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.327||0.7499||95.0|-0.541|0.75|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.750|-0.541|0.7499
71042567|NCT00442546|141594083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|0.333||0.8231||95.0|-0.584|0.733|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.733|-0.584|0.8231
71042568|NCT00442546|141594084|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.036|STANDARD_ERROR_OF_MEAN|0.709||0.1486||95.0|-2.452|0.379|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours||0.379|-2.452|0.1486
71042569|NCT00442546|141594084|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.903|STANDARD_ERROR_OF_MEAN|0.706||0.0089||95.0|-3.311|-0.494|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours||-0.494|-3.311|0.0089
71042570|NCT00442546|141594084|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.344||0.8995||95.0|-0.635|0.722|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.722|-0.635|0.8995
71042571|NCT00442546|141594084|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.303|STANDARD_ERROR_OF_MEAN|0.354||0.3918||95.0|-1.0|0.394|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.394|-1.000|0.3918
71042572|NCT00442546|141594084|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.33||0.9942||95.0|-0.648|0.652|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.652|-0.648|0.9942
71042573|NCT00442546|141594084|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.206|STANDARD_ERROR_OF_MEAN|0.332||0.5352||95.0|-0.859|0.448|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.448|-0.859|0.5352
71042574|NCT00442546|141594084|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.382||0.8055||95.0|-0.662|0.85|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.850|-0.662|0.8055
71042575|NCT00442546|141594084|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.446|STANDARD_ERROR_OF_MEAN|0.391||0.256||95.0|-1.22|0.327|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.327|-1.220|0.2560
71042576|NCT00442546|141594084|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.641||0.8744||95.0|-1.184|1.387|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||1.387|-1.184|0.8744
71042577|NCT00442546|141594084|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.614|STANDARD_ERROR_OF_MEAN|0.616||0.0115||95.0|-2.851|-0.378|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||-0.378|-2.851|0.0115
71042578|NCT00442546|141594084|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.077|STANDARD_ERROR_OF_MEAN|1.155||0.9497||95.0|-3.047|2.893|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||2.893|-3.047|0.9497
71042579|NCT00442546|141594084|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.347|STANDARD_ERROR_OF_MEAN|1.992||0.5288||95.0|-6.467|3.773|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||3.773|-6.467|0.5288
71042580|NCT00442546|141594084|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.296|STANDARD_ERROR_OF_MEAN|0.262||0.2595||95.0|-0.813|0.22|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.220|-0.813|0.2595
70924265|NCT02724878|141340903|SUPERIORITY||Response Rate|33.0|||||TWO_SIDED|80.0|25.0|42.0||||||A sample size of 60 would provide 95% power to distinguish the ORR rate of 25% from 10% (historical control) with 1-sided alpha of 0.07. The treatment would be considered effective if 10 or more responses are observed out of 60 patients.||42|25|
70924266|NCT04838262|141340925|OTHER|||||||0.57|||||||Regression, Linear|||||||0.57
71042581|NCT00442546|141594084|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.013|STANDARD_ERROR_OF_MEAN|0.27||0.9605||95.0|-0.546|0.519|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.519|-0.546|0.9605
71001621|NCT00937326|141511046|SUPERIORITY|||||||0.85||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 15 for FPG.||||0.850
71001622|NCT00937326|141511046|SUPERIORITY|||||||0.843||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 15 for FPG.||||0.843
71001623|NCT00937326|141511046|SUPERIORITY|||||||0.961||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 15 for FPG.||||0.961
71001624|NCT00937326|141511046|SUPERIORITY|||||||0.939||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 15 for FPG.||||0.939
71001625|NCT00937326|141511046|SUPERIORITY|||||||0.966||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 22 for FPG.||||0.966
71001626|NCT00937326|141511046|SUPERIORITY|||||||0.075||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 22 for FPG.||||0.075
71001627|NCT00937326|141511046|SUPERIORITY|||||||0.7||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 22 for FPG.||||0.700
71001628|NCT00937326|141511046|SUPERIORITY|||||||0.732||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 22 for FPG.||||0.732
71001629|NCT00937326|141511046|SUPERIORITY|||||||0.552||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 28 for FPG.||||0.552
71001630|NCT00937326|141511046|SUPERIORITY|||||||0.196||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 28 for FPG.||||0.196
71001631|NCT00937326|141511046|SUPERIORITY|||||||0.393||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 28 for FPG.||||0.393
71001632|NCT00937326|141511046|SUPERIORITY|||||||0.775||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 28 for FPG.||||0.775
71001633|NCT00937326|141511046|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 35 for FPG.||||1.000
71001634|NCT00937326|141511046|SUPERIORITY|||||||0.989||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 35 for FPG.||||0.989
71001635|NCT00937326|141511046|SUPERIORITY|||||||0.603||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 35 for FPG.||||0.603
71042582|NCT00442546|141594084|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.207|STANDARD_ERROR_OF_MEAN|0.251||0.4107||95.0|-0.702|0.288|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.288|-0.702|0.4107
71042583|NCT00442546|141594084|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.318|STANDARD_ERROR_OF_MEAN|0.263||0.2271||95.0|-0.836|0.2|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.200|-0.836|0.2271
70924267|NCT04838262|141340925|OTHER|||||||0.85|||||||Regression, Linear|||||||0.85
70924268|NCT03175029|141340932|SUPERIORITY||Mean Difference (Final Values)|10.552|||<|0.001|TWO_SIDED|95.0|5.514|15.59|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BCI in the TAC-302 group||15.590|5.514|<0.001
71042584|NCT00442546|141594084|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.263||0.9552||95.0|-0.535|0.506|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.506|-0.535|0.9552
71042585|NCT00442546|141594084|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.268||0.9899||95.0|-0.533|0.526|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.526|-0.533|0.9899
70924269|NCT03175029|141340932|SUPERIORITY||Mean Difference (Final Values)|-0.826||||0.819|TWO_SIDED|95.0|-8.676|7.023|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BCI in the Placebo group||7.023|-8.676|0.819
71001636|NCT00937326|141511046|SUPERIORITY|||||||0.108||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 35 for FPG.||||0.108
71042586|NCT00442546|141594085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.578|STANDARD_ERROR_OF_MEAN|0.471||0.2211||95.0|-0.35|1.506|||ANOVA||Mean difference (final values) = Least squares mean difference|4 hours||1.506|-0.350|0.2211
71042587|NCT00442546|141594085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.809|STANDARD_ERROR_OF_MEAN|0.477||0.0916||95.0|-1.75|0.132|||ANOVA||Mean difference (final values) = Least squares mean difference|4 hours||0.132|-1.750|0.0916
71001637|NCT00937326|141511047|SUPERIORITY|||||||0.525||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 8.||||0.525
71001638|NCT00937326|141511047|SUPERIORITY|||||||0.818||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 8.||||0.818
71001639|NCT00937326|141511047|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 8.||||0.999
71042588|NCT00442546|141594085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.036|STANDARD_ERROR_OF_MEAN|0.42||0.9312||95.0|-0.863|0.791|||ANOVA||Mean difference (final values) = Least squares mean difference|8 hours||0.791|-0.863|0.9312
71042589|NCT00442546|141594085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.591|STANDARD_ERROR_OF_MEAN|0.425||0.1658||95.0|-1.428|0.247|||ANOVA||Mean difference (final values) = Least squares mean difference|8 hours||0.247|-1.428|0.1658
71042590|NCT00442546|141594085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.483||0.9921||95.0|-0.958|0.948|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours||0.948|-0.958|0.9921
70924270|NCT03175029|141340932|SUPERIORITY||Mean Difference (Final Values)|11.378|STANDARD_ERROR_OF_MEAN|4.454||0.015|TWO_SIDED|95.0|2.345|20.411|||t-test, 2 sided|||TAC-302 group vs. Placebo group for changes in the mean BCI from baseline to Week 12||20.411|2.345|0.015
71042591|NCT00442546|141594085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.715|STANDARD_ERROR_OF_MEAN|0.479||0.1367||95.0|-1.66|0.229|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours||0.229|-1.660|0.1367
71042592|NCT00442546|141594085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.336|STANDARD_ERROR_OF_MEAN|0.364||0.3561||95.0|-1.053|0.38|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.380|-1.053|0.3561
71042593|NCT00442546|141594085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.291|STANDARD_ERROR_OF_MEAN|0.366||0.426||95.0|-1.012|0.429|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.429|-1.012|0.4260
71042594|NCT00442546|141594085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.105|STANDARD_ERROR_OF_MEAN|0.41||0.7975||95.0|-0.703|0.914|||ANOVA||Mean difference (final values) = Least squares mean difference|32 hours||0.914|-0.703|0.7975
71042595|NCT00442546|141594085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.412||0.6947||95.0|-0.65|0.974|||ANOVA||Mean difference (final values) = Least squares mean difference|32 hours||0.974|-0.650|0.6947
71042596|NCT00442546|141594085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.182|STANDARD_ERROR_OF_MEAN|0.465||0.6954||95.0|-1.101|0.736|||ANOVA||Mean difference (final values) = Least squares mean difference|40 hours||0.736|-1.101|0.6954
71042597|NCT00442546|141594085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.081|STANDARD_ERROR_OF_MEAN|0.481||0.8665||95.0|-1.032|0.87|||ANOVA||Mean difference (final values) = Least squares mean difference|40 hours||0.870|-1.032|0.8665
71042598|NCT00442546|141594085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.311|STANDARD_ERROR_OF_MEAN|0.386||0.4216||95.0|-0.45|1.072|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||1.072|-0.450|0.4216
71042599|NCT00442546|141594085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.285|STANDARD_ERROR_OF_MEAN|0.391||0.4673||95.0|-0.487|1.056|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||1.056|-0.487|0.4673
71042600|NCT00442546|141594085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.255|STANDARD_ERROR_OF_MEAN|0.44||0.5624||95.0|-0.614|1.125|||ANOVA||Mean difference (final values) = Least squares mean difference|56 hours||1.125|-0.614|0.5624
71042601|NCT00442546|141594085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.402|STANDARD_ERROR_OF_MEAN|0.448||0.3705||95.0|-1.286|0.482|||ANOVA||Mean difference (final values) = Least squares mean difference|56 hours||0.482|-1.286|0.3705
71042602|NCT00442546|141594085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.358|STANDARD_ERROR_OF_MEAN|0.476||0.4539||95.0|-1.302|0.586|||ANOVA||Mean difference (final values) = Least squares mean difference|64 hours||0.586|-1.302|0.4539
71042603|NCT00442546|141594085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.086|STANDARD_ERROR_OF_MEAN|0.515||0.0373||95.0|-2.107|-0.065|||ANOVA||Mean difference (final values) = Least squares mean difference|64 hours||-0.065|-2.107|0.0373
71042604|NCT00442546|141594085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.146|STANDARD_ERROR_OF_MEAN|0.476||0.76||95.0|-0.796|1.087|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||1.087|-0.796|0.7600
71042605|NCT00442546|141594085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.555|STANDARD_ERROR_OF_MEAN|0.481||0.2506||95.0|-1.507|0.397|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.397|-1.507|0.2506
71100730|NCT02732145|141709685|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Labia Minora in patients with impaired vulvar skin?||||||0.0006|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Labia Minora in patients with impaired vulvar skin.||||0.0006
71001640|NCT00937326|141511047|SUPERIORITY|||||||0.809||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 8.||||0.809
71001641|NCT00937326|141511047|SUPERIORITY|||||||0.993||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 15.||||0.993
71001642|NCT00937326|141511047|SUPERIORITY|||||||0.954||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 15.||||0.954
71001643|NCT00937326|141511047|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 15.||||1.000
71001644|NCT00937326|141511047|SUPERIORITY|||||||0.344||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 15.||||0.344
71001645|NCT00937326|141511047|SUPERIORITY|||||||0.968||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 22.||||0.968
71042606|NCT00442546|141594085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.027|STANDARD_ERROR_OF_MEAN|0.895||0.2567||95.0|-0.77|2.823|||ANOVA||Mean difference (final values) = Least squares mean difference|80 hours||2.823|-0.770|0.2567
71042607|NCT00442546|141594085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.882|STANDARD_DEVIATION|0.76||0.0167||95.0|-3.408|-0.356|||ANOVA||Mean difference (final values) = Least squares mean difference|80 hours||-0.356|-3.408|0.0167
71042608|NCT00442546|141594085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.352|STANDARD_ERROR_OF_MEAN|0.89||0.6953||95.0|-1.456|2.159|||ANOVA||Mean difference (final values) = Least squares mean difference|88 hours||2.159|-1.456|0.6953
71042609|NCT00442546|141594085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.147|STANDARD_ERROR_OF_MEAN|0.894||0.208||95.0|-2.962|0.668|||ANOVA||Mean difference (final values) = Least squares mean difference|88 hours||0.668|-2.962|0.2080
71042610|NCT00442546|141594085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.867|STANDARD_ERROR_OF_MEAN|0.975||0.3805||95.0|-1.116|2.849|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||2.849|-1.116|0.3805
71042611|NCT00442546|141594085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.126|STANDARD_ERROR_OF_MEAN|0.905||0.89||95.0|-1.965|1.713|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||1.713|-1.965|0.8900
71042612|NCT00442546|141594085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.672|STANDARD_ERROR_OF_MEAN|1.08||0.1821||95.0|-1.103|4.448|||ANOVA||Mean difference (final values) = Least squares mean difference|104 hours||4.448|-1.103|0.1821
71001646|NCT00937326|141511047|SUPERIORITY|||||||0.316||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 22.||||0.316
71001647|NCT00937326|141511047|SUPERIORITY|||||||0.984||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 22.||||0.984
70924271|NCT03175029|141340933|SUPERIORITY||Mean Difference (Final Values)|10.604|STANDARD_DEVIATION|8.76|<|0.001|TWO_SIDED|95.0|5.753|15.455|||t-test, 2 sided|||Baseline vs. Week 12 for the mean PIP1 in the TAC-302 group||15.455|5.753|<0.001
70924272|NCT03175029|141340933|SUPERIORITY||Mean Difference (Final Values)|4.926|STANDARD_DEVIATION|7.62||0.138|TWO_SIDED|95.0|-2.121|11.973|||t-test, 2 sided|||Baseline vs. Week 12 for the mean PIP1 in the Placebo group||11.973|-2.121|0.138
70924273|NCT03175029|141340933|SUPERIORITY||Mean Difference (Final Values)|5.678|STANDARD_ERROR_OF_MEAN|3.861||0.157|TWO_SIDED|95.0|-2.375|13.731|||t-test, 2 sided|||TAC-302 group vs. Placebo group for changes in the mean PIP1 from baseline to Week 12||13.731|-2.375|0.157
71042613|NCT00442546|141594085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.851|STANDARD_ERROR_OF_MEAN|1.768||0.6505||95.0|-3.693|5.395|||ANOVA||Mean difference (final values) = Least squares mean difference|104 hours||5.395|-3.693|0.6505
71042614|NCT00442546|141594086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.029|STANDARD_ERROR_OF_MEAN|0.495||0.0388||95.0|-2.004|-0.053|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||-0.053|-2.004|0.0388
71042615|NCT00442546|141594086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|0.501||0.0004||95.0|-2.798|-0.822|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||-0.822|-2.798|0.0004
71042616|NCT00442546|141594086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.197|STANDARD_ERROR_OF_MEAN|0.405||0.6274||95.0|-0.995|0.601|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.601|-0.995|0.6274
71042617|NCT00442546|141594086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.619|STANDARD_ERROR_OF_MEAN|0.413||0.135||95.0|-1.432|0.194|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.194|-1.432|0.1350
71042618|NCT00442546|141594086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.719|STANDARD_ERROR_OF_MEAN|0.448||0.1106||95.0|-1.605|0.166|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.166|-1.605|0.1106
71042619|NCT00442546|141594086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.036|STANDARD_ERROR_OF_MEAN|0.457||0.0248||95.0|-1.939|-0.133|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||-0.133|-1.939|0.0248
71100731|NCT02732145|141709685|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin.||||0.0000
71100732|NCT02732145|141709685|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Interlabial Sulci versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin?||||||0.0003|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Interlabial Sulci versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin.||||0.0003
71100733|NCT02732145|141709685|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin.||||0.0000
71100734|NCT02732145|141709685|SUPERIORITY|Question: Is there a difference in the incidence of specific lesion of the Anterior Commissure versus specific lesions of Interlabial Sulci in patients with vulvar dermatosis?||||||0.3053|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Anterior Commissure versus specific lesions of Interlabial Sulci in patients with vulvar dermatosis.||||0.3053
70924274|NCT03175029|141340934|SUPERIORITY||Mean Difference (Final Values)|10.91|STANDARD_DEVIATION|26.48||0.006|TWO_SIDED|95.0|3.22|18.59|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BVE in the TAC-302 group||18.59|3.22|0.006
70924275|NCT03175029|141340934|SUPERIORITY||Mean Difference (Final Values)|2.42|STANDARD_DEVIATION|20.09||0.57|TWO_SIDED|95.0|-6.27|11.1|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BVE in the Placebo group||11.10|-6.27|0.570
71042620|NCT00442546|141594086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.874|STANDARD_ERROR_OF_MEAN|0.725||0.2335||95.0|-0.582|2.33|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||2.330|-0.582|0.2335
71042621|NCT00442546|141594086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.568|STANDARD_ERROR_OF_MEAN|0.682||0.0258||95.0|-2.939|-0.198|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||-0.198|-2.939|0.0258
71042622|NCT00442546|141594086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.866|STANDARD_ERROR_OF_MEAN|1.973||0.3878||95.0|-3.207|6.939|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||6.939|-3.207|0.3878
71042623|NCT00442546|141594086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.909|STANDARD_ERROR_OF_MEAN|3.754||0.1762||95.0|-3.74|15.559|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||15.559|-3.740|0.1762
71042624|NCT00442546|141594086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.515|STANDARD_ERROR_OF_MEAN|0.379||0.1754||95.0|-1.261|0.231|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.231|-1.261|0.1754
71042625|NCT00442546|141594086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.569|STANDARD_ERROR_OF_MEAN|0.386||0.1413||95.0|-1.329|0.191|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.191|-1.329|0.1413
71042626|NCT00442546|141594086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.419|STANDARD_ERROR_OF_MEAN|0.306||0.1731||95.0|-1.023|0.185|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.185|-1.023|0.1731
71042627|NCT00442546|141594086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.128|STANDARD_ERROR_OF_MEAN|0.314||0.6829||95.0|-0.747|0.49|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.490|-0.747|0.6829
71042628|NCT00442546|141594086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.351|STANDARD_ERROR_OF_MEAN|0.3||0.2436||95.0|-0.943|0.241|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.241|-0.943|0.2436
71042629|NCT00442546|141594086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.313||0.119||95.0|-1.108|0.127|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.127|-1.108|0.1190
71001648|NCT00937326|141511047|SUPERIORITY|||||||0.235||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 22.||||0.235
71001649|NCT00937326|141511047|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 28.||||1.000
71001650|NCT00937326|141511047|SUPERIORITY|||||||0.656||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 28.||||0.656
71001651|NCT00937326|141511047|SUPERIORITY|||||||0.994||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 28.||||0.994
71001652|NCT00937326|141511047|SUPERIORITY|||||||0.285||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 28.||||0.285
71001653|NCT00937326|141511047|SUPERIORITY|||||||0.992||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 35.||||0.992
71001654|NCT00937326|141511047|SUPERIORITY|||||||0.822||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 35.||||0.822
71001655|NCT00937326|141511047|SUPERIORITY|||||||0.538||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 35.||||0.538
71001656|NCT00937326|141511047|SUPERIORITY|||||||0.907||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 35.||||0.907
71001657|NCT00937326|141511048|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 8 for FPI.||||0.999
71001658|NCT00937326|141511048|SUPERIORITY|||||||0.982||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 8 for FPI.||||0.982
71042630|NCT00442546|141594086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.264|STANDARD_ERROR_OF_MEAN|0.321||0.4117||95.0|-0.897|0.369|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.369|-0.897|0.4117
71001659|NCT00937326|141511048|SUPERIORITY|||||||0.677||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 8 for FPI.||||0.677
71001660|NCT00937326|141511048|SUPERIORITY|||||||0.688||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 8 for FPI.||||0.688
71001661|NCT00937326|141511048|SUPERIORITY|||||||0.903||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 15 for FPI.||||0.903
71042631|NCT00442546|141594086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.156|STANDARD_ERROR_OF_MEAN|0.323||0.6294||95.0|-0.794|0.482|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.482|-0.794|0.6294
71042632|NCT00442546|141594087|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.859|STANDARD_ERROR_OF_MEAN|3.315||0.7958||95.0|-7.391|5.673|||ANOVA||Mean difference (final values) = Least squares mean difference|Day 1||5.673|-7.391|0.7958
71042633|NCT00442546|141594087|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|3.322||0.9733||95.0|-6.436|6.659|||ANOVA||Mean difference (final values) = Least squares mean difference|Day 1||6.659|-6.436|0.9733
70924276|NCT03175029|141340934|SUPERIORITY||Mean Difference (Final Values)|8.49|STANDARD_ERROR_OF_MEAN|6.24||0.178|TWO_SIDED|95.0|-3.96|20.95|||t-test, 2 sided|||TAC-302 group vs. Placebo group for changes in the mean BVE from baseline to Week 12||20.95|-3.96|0.178
71001662|NCT00937326|141511048|SUPERIORITY|||||||0.945||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 15 for FPI.||||0.945
71001663|NCT00937326|141511048|SUPERIORITY|||||||0.949||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 15 for FPI.||||0.949
71001664|NCT00937326|141511048|SUPERIORITY|||||||0.924||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 15 for FPI.||||0.924
71042634|NCT00442546|141594087|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.889|STANDARD_ERROR_OF_MEAN|3.946||0.822||95.0|-6.898|8.675|||ANOVA||Mean difference (final values) = Least squares mean difference|1 hour||8.675|-6.898|0.8220
71042635|NCT00442546|141594087|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.813|STANDARD_ERROR_OF_MEAN|3.917||0.4736||95.0|-10.542|4.917|||ANOVA||Mean difference (final values) = Least squares mean difference|1 hour||4.917|-10.542|0.4736
71042636|NCT00442546|141594087|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.662|STANDARD_ERROR_OF_MEAN|4.045||0.5113||95.0|-10.639|5.316|||ANOVA||Mean difference (final values) = Least squares mean difference|2 hours||5.316|-10.639|0.5113
71042637|NCT00442546|141594087|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.365|STANDARD_ERROR_OF_MEAN|3.95||0.9266||95.0|-7.425|8.154|||ANOVA||Mean difference (final values) = Least squares mean difference|2 hours||8.154|-7.425|0.9266
71042638|NCT00442546|141594087|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|4.347||0.9699||95.0|-8.423|8.751|||ANOVA||Mean difference (final values) = Least squares mean difference|3 hours||8.751|-8.423|0.9699
71042639|NCT00442546|141594087|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.275|STANDARD_ERROR_OF_MEAN|4.232||0.9482||95.0|-8.085|8.635|||ANOVA||Mean difference (final values) = Least squares mean difference|3 hours||8.635|-8.085|0.9482
70924277|NCT03175029|141340935|SUPERIORITY||Mean Difference (Final Values)|18.41|STANDARD_DEVIATION|24.39|<|0.001|TWO_SIDED|95.0|9.13|27.69|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BVE in the TAC-302 group||27.69|9.13|<0.001
70924278|NCT03175029|141340935|SUPERIORITY||Mean Difference (Final Values)|2.88|STANDARD_DEVIATION|15.7||0.489|TWO_SIDED|95.0|-5.81|11.58|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BVE in the Placebo group||11.58|-5.81|0.489
71001665|NCT00937326|141511048|SUPERIORITY|||||||0.394||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 22 for FPI.||||0.394
71001666|NCT00937326|141511048|SUPERIORITY|||||||0.687||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 22 for FPI.||||0.687
71001667|NCT00937326|141511048|SUPERIORITY|||||||0.568||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 22 for FPI.||||0.568
71001668|NCT00937326|141511048|SUPERIORITY|||||||0.486||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 22 for FPI.||||0.486
71042640|NCT00442546|141594087|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.915|STANDARD_ERROR_OF_MEAN|7.391||0.7969||95.0|-16.842|13.012|||ANOVA||Mean difference (final values) = Least squares mean difference|4 hours||13.012|-16.842|0.7969
71042641|NCT00442546|141594087|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.023|STANDARD_ERROR_OF_MEAN|7.68||0.1991||95.0|-25.533|5.487|||ANOVA||Mean difference (final values) = Least squares mean difference|4 hours||5.487|-25.533|0.1991
71042642|NCT00442546|141594087|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|86.335|STANDARD_ERROR_OF_MEAN|22.737||0.0321||95.0|13.976|158.693|||ANOVA||Mean difference (final values) = Least squares mean difference|5 hours||158.693|13.976|0.0321
71042643|NCT00442546|141594087|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|44.964|STANDARD_ERROR_OF_MEAN|12.295||0.0353||95.0|5.837|84.091|||ANOVA||Mean difference (final values) = Least squares mean difference|5 hours||84.091|5.837|0.0353
71042644|NCT00442546|141594088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.812|STANDARD_ERROR_OF_MEAN|12.055||0.5736||95.0|-30.792|17.169|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||17.169|-30.792|0.5736
71042645|NCT00442546|141594088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.991|STANDARD_ERROR_OF_MEAN|11.786||0.8003||95.0|-26.438|20.455|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||20.455|-26.438|0.8003
71042646|NCT00442546|141594088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.815|STANDARD_ERROR_OF_MEAN|10.371||0.5125||95.0|-27.369|13.74|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||13.740|-27.369|0.5125
71001669|NCT00937326|141511048|SUPERIORITY|||||||0.973||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 28 for FPI.||||0.973
71001670|NCT00937326|141511048|SUPERIORITY|||||||0.739||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 28 for FPI.||||0.739
71001671|NCT00937326|141511048|SUPERIORITY|||||||0.731||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 28 for FPI.||||0.731
71001672|NCT00937326|141511048|SUPERIORITY|||||||0.991||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 28 for FPI.||||0.991
71001673|NCT00937326|141511048|SUPERIORITY|||||||0.994||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 35 for FPI.||||0.994
71001674|NCT00937326|141511048|SUPERIORITY|||||||0.963||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 35 for FPI.||||0.963
71001675|NCT00937326|141511048|SUPERIORITY|||||||0.929||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 35 for FPI.||||0.929
71001676|NCT00937326|141511048|SUPERIORITY|||||||0.97||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 35 for FPI.||||0.970
71001677|NCT00937326|141511049|SUPERIORITY|||||||0.989||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 8.||||0.989
71001678|NCT00937326|141511049|SUPERIORITY|||||||0.989||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 8.||||0.989
71001679|NCT00937326|141511049|SUPERIORITY|||||||0.982||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 8.||||0.982
71042647|NCT00442546|141594088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.294|STANDARD_ERROR_OF_MEAN|10.227||0.4773||95.0|-27.563|12.976|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||12.976|-27.563|0.4773
71042648|NCT00442546|141594088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.915|STANDARD_ERROR_OF_MEAN|11.101||0.2142||95.0|-36.055|8.226|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||8.226|-36.055|0.2142
70924279|NCT03175029|141340935|SUPERIORITY||Mean Difference (Final Values)|15.53|STANDARD_ERROR_OF_MEAN|6.96||0.031|TWO_SIDED|95.0|1.48|29.58|||t-test, 2 sided|||TAC-302 group vs. Placebo group for changes in the mean BVE from baseline to Week 12||29.58|1.48|0.031
71001680|NCT00937326|141511049|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 8.||||0.999
71001681|NCT00937326|141511049|SUPERIORITY|||||||0.685||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 15.||||0.685
71042649|NCT00442546|141594088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.769|STANDARD_ERROR_OF_MEAN|11.245||0.2989||95.0|-34.197|10.659|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||10.659|-34.197|0.2989
71042650|NCT00442546|141594088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|40.51|STANDARD_ERROR_OF_MEAN|45.612||0.3829||95.0|-53.429|134.449|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||134.449|-53.429|0.3829
71042651|NCT00442546|141594088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-27.25|STANDARD_ERROR_OF_MEAN|45.322||0.5531||95.0|-120.59|66.092|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||66.092|-120.59|0.5531
71001682|NCT00937326|141511049|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 15.||||0.999
71001683|NCT00937326|141511049|SUPERIORITY|||||||0.971||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 15.||||0.971
71001684|NCT00937326|141511049|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 15.||||1.000
71001685|NCT00937326|141511049|SUPERIORITY|||||||0.405||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 22.||||0.405
71001686|NCT00937326|141511049|SUPERIORITY|||||||0.975||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 22.||||0.975
71001687|NCT00937326|141511049|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 22.||||0.999
71042652|NCT00442546|141594088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.513|STANDARD_ERROR_OF_MEAN|8.491||0.2738||95.0|-89.376|126.402|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||126.402|-89.376|0.2738
71001688|NCT00937326|141511049|SUPERIORITY|||||||0.629||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 22.||||0.629
71001689|NCT00937326|141511049|SUPERIORITY|||||||0.982||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 28.||||0.982
71001690|NCT00937326|141511049|SUPERIORITY|||||||0.982||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 28.||||0.982
71001691|NCT00937326|141511049|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 28.||||0.999
71001692|NCT00937326|141511049|SUPERIORITY|||||||0.874||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 28.||||0.874
71001693|NCT00937326|141511049|SUPERIORITY|||||||0.986||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 35.||||0.986
71042653|NCT00442546|141594088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.644|STANDARD_ERROR_OF_MEAN|2.519||0.7987||95.0|-4.343|5.63|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||5.630|-4.343|0.7987
71042654|NCT00442546|141594088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.346|STANDARD_ERROR_OF_MEAN|2.441||0.8875||95.0|-5.177|4.485|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||4.485|-5.177|0.8875
71042655|NCT00442546|141594088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.537|STANDARD_ERROR_OF_MEAN|1.949||0.4319||95.0|-2.324|5.398|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||5.398|-2.324|0.4319
71042656|NCT00442546|141594088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.61|STANDARD_ERROR_OF_MEAN|1.935||0.407||95.0|-2.223|5.443|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||5.443|-2.223|0.4070
71042657|NCT00442546|141594088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.119|STANDARD_ERROR_OF_MEAN|1.641||0.4968||95.0|-4.371|2.133|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||2.133|-4.371|0.4968
71042658|NCT00442546|141594088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.327|STANDARD_ERROR_OF_MEAN|1.665||0.427||95.0|-1.972|4.626|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||4.626|-1.972|0.4270
70924280|NCT03175029|141340936|SUPERIORITY||Mean Difference (Final Values)|23.57|STANDARD_DEVIATION|25.54|<|0.001|TWO_SIDED|95.0|11.26|35.88|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BVE in the TAC-302 group||35.88|11.26|<0.001
71001694|NCT00937326|141511049|SUPERIORITY|||||||0.997||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 35.||||0.997
71001695|NCT00937326|141511049|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 35.||||1.000
71001696|NCT00937326|141511049|SUPERIORITY|||||||0.697||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 35.||||0.697
71001697|NCT00937326|141511050|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 30 minutes for PPG.||||1.000
71001698|NCT00937326|141511050|SUPERIORITY|||||||0.812||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 30 minutes for PPG.||||0.812
71001699|NCT00937326|141511050|SUPERIORITY|||||||0.996||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 30 minutes for PPG.||||0.996
71001700|NCT00937326|141511050|SUPERIORITY|||||||0.198||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 30 minutes for PPG.||||0.198
71001701|NCT00937326|141511050|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 60 minutes for PPG.||||1.000
71001702|NCT00937326|141511050|SUPERIORITY|||||||0.358||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 60 minutes for PPG.||||0.358
71001703|NCT00937326|141511050|SUPERIORITY|||||||0.852||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 60 minutes for PPG.||||0.852
71001704|NCT00937326|141511050|SUPERIORITY|||||||0.678||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 60 minutes for PPG.||||0.678
71001705|NCT00937326|141511050|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 2 hour for PPG.||||1.000
71001706|NCT00937326|141511050|SUPERIORITY|||||||0.191||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 2 hour for PPG.||||0.191
71001707|NCT00937326|141511050|SUPERIORITY|||||||0.805||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 2 hour for PPG.||||0.805
71001708|NCT00937326|141511050|SUPERIORITY|||||||0.96||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 2 hour for PPG.||||0.960
71001709|NCT00937326|141511050|SUPERIORITY|||||||0.985||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 30 minutes for PPI.||||0.985
70924281|NCT03175029|141340936|SUPERIORITY||Mean Difference (Final Values)|2.1|STANDARD_DEVIATION|17.18||0.708|TWO_SIDED|95.0|-10.19|14.4|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BVE in the Placebo group||14.40|-10.19|0.708
71001710|NCT00937326|141511050|SUPERIORITY|||||||0.733||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 30 minutes for PPI.||||0.733
71001711|NCT00937326|141511050|SUPERIORITY|||||||0.365||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 30 minutes for PPI.||||0.365
71001712|NCT00937326|141511050|SUPERIORITY|||||||0.413||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 30 minutes for PPI.||||0.413
71001713|NCT00937326|141511050|SUPERIORITY|||||||0.765||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 60 minutes for PPI.||||0.765
71001714|NCT00937326|141511050|SUPERIORITY|||||||0.434||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 60 minutes for PPI.||||0.434
71001715|NCT00937326|141511050|SUPERIORITY|||||||0.184||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 60 minutes for PPI.||||0.184
71001716|NCT00937326|141511050|SUPERIORITY|||||||0.142||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 60 minutes for PPI.||||0.142
71001717|NCT00937326|141511050|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 2 hour for PPI.||||0.999
71001718|NCT00937326|141511050|SUPERIORITY|||||||0.876||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 2 hour for PPI.||||0.876
71100735|NCT02732145|141709685|SUPERIORITY|Question: Is there a difference in the incidence of specific lesion of the Anterior Commissure versus specific lesions of Labia Minora in patients with vulvar dermatosis?||||||0.7758|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Anterior Commissure versus specific lesions of Labia Minora in patients with vulvar dermatosis.||||0.7758
71100736|NCT02732145|141709685|SUPERIORITY|Question: Is there a difference in the incidence of specific lesion of the Anterior Commissure versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis?||||||0.6676|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Anterior Commissure versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis.||||0.6676
71100737|NCT02732145|141709685|SUPERIORITY|Question: Is there a difference in the incidence of specific lesion of Interlabial Sulci versus specific lesions of Labia Minora in patients with vulvar dermatosis?||||||0.4577|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Interlabial Sulci versus specific lesions of Labia Minora in patients with vulvar dermatosis.||||0.4577
71100738|NCT02732145|141709685|SUPERIORITY|Question: Is there a difference in the incidence of specific lesion of Interlabial Sulci versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis?||||||0.1681|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Interlabial Sulci versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis.||||0.1681
71100739|NCT02732145|141709685|SUPERIORITY|Question: Is there a difference in the incidence of specific lesion of Labia Minora versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis?||||||0.8848|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Labia Minora versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis.||||0.8848
70924282|NCT03175029|141340936|SUPERIORITY||Mean Difference (Final Values)|21.47|STANDARD_ERROR_OF_MEAN|9.02||0.025|TWO_SIDED|95.0|2.96|39.98|||t-test, 2 sided|||TAC-302 group vs. Placebo group for changes in the mean BVE from baseline to Week 12||39.98|2.96|0.025
71001719|NCT00937326|141511050|SUPERIORITY|||||||0.756||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 2 hour for PPI.||||0.756
71001720|NCT00937326|141511050|SUPERIORITY|||||||0.983||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 2 hour for PPI.||||0.983
70924283|NCT03381261|141340949|OTHER|While descriptive statistics were presented in the original mRNA units using median and interquartile range (25th, 75th), statistical group comparison and effect sizes were reported as the ratio of the geometric means.|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71001721|NCT00937326|141511051|SUPERIORITY|||||||0.809||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPG at 30 minutes.||||0.809
71001722|NCT00937326|141511051|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPG at 30 minutes.||||1.000
71001723|NCT00937326|141511051|SUPERIORITY|||||||0.989||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPG at 30 minutes.||||0.989
71001724|NCT00937326|141511051|SUPERIORITY|||||||0.13||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPG at 30 minutes.||||0.130
71001725|NCT00937326|141511051|SUPERIORITY|||||||0.87||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPG at 60 minutes.||||0.870
71001726|NCT00937326|141511051|SUPERIORITY|||||||0.864||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPG at 60 minutes.||||0.864
71001727|NCT00937326|141511051|SUPERIORITY|||||||0.997||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPG at 60 minutes.||||0.997
71001728|NCT00937326|141511051|SUPERIORITY|||||||0.682||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPG at 60 minutes.||||0.682
71001729|NCT00937326|141511051|SUPERIORITY|||||||0.798||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPG at 2 hour.||||0.798
71042659|NCT00442546|141594089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.862|STANDARD_ERROR_OF_MEAN|2.999||0.7742||95.0|-6.775|5.052|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||5.052|-6.775|0.7742
71042660|NCT00442546|141594089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.006|STANDARD_ERROR_OF_MEAN|3.025||0.0996||95.0|-0.96|10.971|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||10.971|-0.960|0.0996
71042661|NCT00442546|141594089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.803|STANDARD_ERROR_OF_MEAN|2.79||0.7738||95.0|-4.698|6.304|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||6.304|-4.698|0.7738
71042662|NCT00442546|141594089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.192|STANDARD_ERROR_OF_MEAN|2.778||0.1328||95.0|-1.284|9.669|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||9.669|-1.284|0.1328
71042663|NCT00442546|141594089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.928|STANDARD_ERROR_OF_MEAN|3.012||0.7585||95.0|-5.027|6.882|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||6.882|-5.027|0.7585
71042664|NCT00442546|141594089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.946|STANDARD_ERROR_OF_MEAN|2.997||0.19||95.0|-1.979|9.871|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||9.871|-1.979|0.1900
71042665|NCT00442546|141594089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.43|STANDARD_ERROR_OF_MEAN|3.693||0.2365||95.0|-3.004|11.865|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||11.865|-3.004|0.2365
71042666|NCT00442546|141594089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.306|STANDARD_ERROR_OF_MEAN|3.73||0.1616||95.0|-2.202|12.814|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||12.814|-2.202|0.1616
71042667|NCT00442546|141594089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.071|STANDARD_ERROR_OF_MEAN|6.911||0.8819||95.0|-17.98|15.838|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||15.838|-17.98|0.8819
70924284|NCT03761537|141340959|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Risk Difference (RD)|14.1||||0.018|TWO_SIDED|95.0|2.5|25.7||This endpoint was the first endpoint in the sequential testing hierarchy.|Mantel Haenszel|Mantel-Haenszel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.||Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.||25.7|2.5|0.018
71001730|NCT00937326|141511051|SUPERIORITY|||||||0.73||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPG at 2 hour.||||0.730
70924285|NCT03761537|141340960|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Risk Difference (RD)|9.7||||0.106|TWO_SIDED|95.0|-2.0|21.4||This endpoint was the second endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Mantel Haenszel|Mantel-Haenszel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.||Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.||21.4|-2.0|0.106
71001731|NCT00937326|141511051|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPG at 2 hour.||||1.000
71001732|NCT00937326|141511051|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPG at 2 hour.||||1.000
71001733|NCT00937326|141511051|SUPERIORITY|||||||0.464||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPI at 30 minutes.||||0.464
71001734|NCT00937326|141511051|SUPERIORITY|||||||0.634||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPI at 30 minutes.||||0.634
71001735|NCT00937326|141511051|SUPERIORITY|||||||0.254||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPI at 30 minutes.||||0.254
71001736|NCT00937326|141511051|SUPERIORITY|||||||0.034||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPI at 30 minutes.||||0.034
71001737|NCT00937326|141511051|SUPERIORITY|||||||0.765||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPI at 60 minutes.||||0.765
71001738|NCT00937326|141511051|SUPERIORITY|||||||0.434||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPI at 60 minutes.||||0.434
71001739|NCT00937326|141511051|SUPERIORITY|||||||0.184||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPI at 60 minutes.||||0.184
71001740|NCT00937326|141511051|SUPERIORITY|||||||0.142||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPI at 60 minutes.||||0.142
71001741|NCT00937326|141511051|SUPERIORITY|||||||0.955||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPI at 2 hour.||||0.955
71001742|NCT00937326|141511051|SUPERIORITY|||||||0.985||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPI at 2 hour.||||0.985
71001743|NCT00937326|141511051|SUPERIORITY|||||||0.923||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPI at 2 hour.||||0.923
71001744|NCT00937326|141511051|SUPERIORITY|||||||0.883||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPI at 2 hour.||||0.883
71001745|NCT00937326|141511052|SUPERIORITY|||||||0.118||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.118
71042668|NCT00442546|141594089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.071|STANDARD_ERROR_OF_MEAN|11.7||0.4676||95.0|-37.7|19.558|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||19.558|-37.70|0.4676
71001746|NCT00937326|141511052|SUPERIORITY|||||||0.119||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.119
71001747|NCT00937326|141511052|SUPERIORITY|||||||0.293||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.293
71001748|NCT00937326|141511052|SUPERIORITY|||||||0.966||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.966
71001749|NCT00937326|141511053|SUPERIORITY|||||||0.94||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.940
71001750|NCT00937326|141511053|SUPERIORITY|||||||0.197||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.197
71001751|NCT00937326|141511053|SUPERIORITY|||||||0.097||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.097
71042669|NCT00442546|141594089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.925|STANDARD_ERROR_OF_MEAN|2.195||0.3813||95.0|-2.403|6.254|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||6.254|-2.403|0.3813
71042670|NCT00442546|141594089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.341|STANDARD_ERROR_OF_MEAN|2.236||0.2966||95.0|-2.07|6.751|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||6.751|-2.070|0.2966
71042671|NCT00442546|141594089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.962|STANDARD_ERROR_OF_MEAN|2.576||0.4474||95.0|-3.122|7.046|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||7.046|-3.122|0.4474
71042672|NCT00442546|141594089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.316|STANDARD_ERROR_OF_MEAN|2.59||0.0416||95.0|0.204|10.427|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||10.427|0.204|0.0416
71042673|NCT00442546|141594089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.372|STANDARD_ERROR_OF_MEAN|2.566||0.5935||95.0|-3.694|6.438|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||6.438|-3.694|0.5935
71042674|NCT00442546|141594089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.272|STANDARD_ERROR_OF_MEAN|2.674||0.3966||95.0|-3.006|7.551|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||7.551|-3.006|0.3966
71042675|NCT00442546|141594090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.729|STANDARD_ERROR_OF_MEAN|2.631||0.5117||95.0|-3.457|6.916|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||6.916|-3.457|0.5117
71042676|NCT00442546|141594090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.532|STANDARD_ERROR_OF_MEAN|2.675||0.0154||95.0|1.258|11.805|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||11.805|1.258|0.0154
71001752|NCT00937326|141511053|SUPERIORITY|||||||0.404||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.404
71001753|NCT00937326|141511054|SUPERIORITY|||||||0.206||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 1 for PPG.||||0.2060
71042677|NCT00442546|141594090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.901|STANDARD_ERROR_OF_MEAN|2.353||0.7022||95.0|-3.738|5.54|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||5.540|-3.738|0.7022
71042678|NCT00442546|141594090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.509|STANDARD_ERROR_OF_MEAN|2.343||0.0557||95.0|-0.11|9.129|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||9.129|-0.110|0.0557
71042679|NCT00442546|141594090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.171|STANDARD_ERROR_OF_MEAN|2.552||0.2161||95.0|-1.874|8.215|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||8.215|-1.874|0.2161
71042680|NCT00442546|141594090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.135|STANDARD_ERROR_OF_MEAN|2.548||0.0058||95.0|2.098|12.172|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||12.172|2.098|0.0058
71042681|NCT00442546|141594090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.185|STANDARD_ERROR_OF_MEAN|3.993||0.1283||95.0|-1.853|14.223|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||14.223|-1.853|0.1283
71042682|NCT00442546|141594090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.173|STANDARD_ERROR_OF_MEAN|4.033||0.008||95.0|3.056|19.291|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||19.291|3.056|0.0080
71042683|NCT00442546|141594090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.941|STANDARD_ERROR_OF_MEAN|2.15||0.0018||95.0|7.414|18.468|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||18.468|7.414|0.0018
71001754|NCT00937326|141511054|SUPERIORITY|||||||0.179||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-1 at Day 1 for PPG.||||0.1790
71001755|NCT00937326|141511054|SUPERIORITY|||||||0.2741||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-1 at Day 1 for PPG.||||0.2741
71001756|NCT00937326|141511054|SUPERIORITY|||||||0.6001||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-1 at Day 1 for PPG.||||0.6001
71042684|NCT00442546|141594090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|17.941|STANDARD_ERROR_OF_MEAN|3.533||0.0038||95.0|8.859|27.023|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||27.023|8.859|0.0038
71042685|NCT00442546|141594090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.125|STANDARD_ERROR_OF_MEAN|2.115||0.5953||95.0|-3.045|5.296|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||5.296|-3.045|0.5953
71042686|NCT00442546|141594090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.331|STANDARD_ERROR_OF_MEAN|2.172||0.1267||95.0|-0.952|7.613|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||7.613|-0.952|0.1267
71042687|NCT00442546|141594090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.617|STANDARD_ERROR_OF_MEAN|2.339||0.2647||95.0|-1.997|7.231|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||7.231|-1.997|0.2647
71042688|NCT00442546|141594090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.771|STANDARD_ERROR_OF_MEAN|2.421||0.0181||95.0|0.995|10.548|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||10.548|0.995|0.0181
71042689|NCT00442546|141594090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.374|STANDARD_ERROR_OF_MEAN|2.299||0.5507||95.0|-3.161|5.91|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||5.910|-3.161|0.5507
71042690|NCT00442546|141594090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.404|STANDARD_ERROR_OF_MEAN|2.393||0.3164||95.0|-2.317|7.124|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||7.124|-2.317|0.3164
71042691|NCT00442546|141594091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4365||95.0|||||Log Rank|||||||0.4365
71042692|NCT00442546|141594091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4023||95.0|||||Log Rank|||||||0.4023
71042693|NCT00442546|141594092|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4024||95.0|||||Log Rank|||||||0.4024
71042694|NCT00442546|141594092|SUPERIORITY_OR_OTHER_LEGACY|||||||0.191||95.0|||||Log Rank|||||||0.1910
71042695|NCT00442546|141594093|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.347|STANDARD_ERROR_OF_MEAN|2.497||0.3483||95.0|-2.573|7.268|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||7.268|-2.573|0.3483
71042696|NCT00442546|141594093|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.155|STANDARD_ERROR_OF_MEAN|2.498||0.2078||95.0|-1.766|8.077|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||8.077|-1.766|0.2078
71042697|NCT00442546|141594093|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.126|STANDARD_ERROR_OF_MEAN|6.436||0.4299||95.0|-7.836|18.088|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||18.088|-7.836|0.4299
71042698|NCT00442546|141594093|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.146|STANDARD_ERROR_OF_MEAN|6.726||0.4482||95.0|-8.4|18.693|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||18.693|-8.400|0.4482
71001757|NCT00937326|141511054|SUPERIORITY|||||||0.6711||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 28 for PPG.||||0.6711
71001758|NCT00937326|141511054|OTHER|||||||0.1361||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-1 at Day 28 for PPG.||||0.1361
71001759|NCT00937326|141511054|SUPERIORITY|||||||0.3369||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-1 at Day 28 for PPG.||||0.3369
71001760|NCT00937326|141511054|SUPERIORITY|||||||0.0975||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-1 at Day 28 for PPG.||||0.0975
71001761|NCT00937326|141511054|SUPERIORITY|||||||0.2184||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-2 at Day 1 for PPG.||||0.2184
71001762|NCT00937326|141511054|SUPERIORITY|||||||0.1013||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-2 at Day 1 for PPG.||||0.1013
71001763|NCT00937326|141511054|SUPERIORITY|||||||0.3286||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-2 at Day 1 for PPG.||||0.3286
71001764|NCT00937326|141511054|SUPERIORITY|||||||0.5193||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-2 at Day 1 for PPG.||||0.5193
71001765|NCT00937326|141511054|SUPERIORITY|||||||0.9788||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-2 at Day 28 for PPG.||||0.9788
71001766|NCT00937326|141511054|SUPERIORITY|||||||0.1214||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-2 at Day 28 for PPG.||||0.1214
71001767|NCT00937326|141511054|SUPERIORITY|||||||0.5751||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-2 at Day 28 for PPG.||||0.5751
71001768|NCT00937326|141511054|SUPERIORITY|||||||0.2409||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-2 at Day 28 for PPG.||||0.2409
71001769|NCT00937326|141511054|SUPERIORITY|||||||0.4829||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 1 for PPI.||||0.4829
71001770|NCT00937326|141511054|SUPERIORITY|||||||0.7563||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-1 at Day 1 for PPI.||||0.7563
71001771|NCT00937326|141511054|SUPERIORITY|||||||0.2907||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-1 at Day 1 for PPI.||||0.2907
71001772|NCT00937326|141511054|SUPERIORITY|||||||0.7663||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-1 at Day 1 for PPI.||||0.7663
71001773|NCT00937326|141511054|SUPERIORITY|||||||0.5825||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 28 for PPI||||0.5825
71001774|NCT00937326|141511054|SUPERIORITY|||||||0.322||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-1 at Day 28 for PPI.||||0.3220
71001775|NCT00937326|141511054|SUPERIORITY|||||||0.0564||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-1 at Day 28 for PPI.||||0.0564
71001776|NCT00937326|141511054|SUPERIORITY|||||||0.196||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 28 for PPI.||||0.1960
71001777|NCT00937326|141511054|SUPERIORITY|||||||0.5997||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-2 at Day 1 for PPI.||||0.5997
71001778|NCT00937326|141511054|SUPERIORITY|||||||0.9637||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-2 at Day 1 for PPI.||||0.9637
71001779|NCT00937326|141511054|SUPERIORITY|||||||0.324||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-2 at Day 1 for PPI.||||0.3240
71001780|NCT00937326|141511054|SUPERIORITY|||||||0.844||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-2 at Day 1 for PPI.||||0.8440
71001781|NCT00937326|141511054|SUPERIORITY|||||||0.6483||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-2 at Day 28 for PPI.||||0.6483
71001782|NCT00937326|141511054|SUPERIORITY|||||||0.6452||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-2 at Day 28 for PPI.||||0.6452
71001783|NCT00937326|141511054|SUPERIORITY|||||||0.1253||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-2 at Day 28 for PPI.||||0.1253
71001784|NCT00937326|141511054|SUPERIORITY|||||||0.2583||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-2 at Day 28 for PPI.||||0.2583
71001785|NCT00937326|141511055|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 1 for fructosamine.||||1.000
71001786|NCT00937326|141511055|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 1 for fructosamine.||||1.000
71001787|NCT00937326|141511055|SUPERIORITY|||||||0.901||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 1 for fructosamine.||||0.901
71001788|NCT00937326|141511055|SUPERIORITY|||||||0.155||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 1 for fructosamine.||||0.155
71001789|NCT00937326|141511055|SUPERIORITY|||||||0.845||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 28 for fructosamine.||||0.845
71100740|NCT02732145|141709686|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Clitoris in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
71042699|NCT00442546|141594093|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.036|STANDARD_ERROR_OF_MEAN|4.426||0.6472||95.0|-6.818|10.89|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||10.890|-6.818|0.6472
71042700|NCT00442546|141594093|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.156|STANDARD_ERROR_OF_MEAN|4.642||0.4992||95.0|-6.129|12.442|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||12.442|-6.129|0.4992
71100741|NCT02732145|141709686|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Hart's Line in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
71042701|NCT00442546|141594093|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.656|STANDARD_ERROR_OF_MEAN|5.149||0.6072||95.0|-7.578|12.891|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||12.891|-7.578|0.6072
71042702|NCT00442546|141594093|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.963|STANDARD_ERROR_OF_MEAN|4.906||0.3146||95.0|-4.789|14.714|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||14.714|-4.789|0.3146
71042703|NCT00442546|141594094|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.177|STANDARD_ERROR_OF_MEAN|2.326||0.0739||95.0|-0.407|8.76|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||8.760|-0.407|0.0739
71001790|NCT00937326|141511055|SUPERIORITY|||||||0.164||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 28 for fructosamine.||||0.164
71100742|NCT02732145|141709686|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Urethral Sulcus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
71042704|NCT00442546|141594094|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.176|STANDARD_ERROR_OF_MEAN|2.327||0.074||95.0|-0.409|8.761|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||8.761|-0.409|0.0740
71042705|NCT00442546|141594094|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.298|STANDARD_ERROR_OF_MEAN|6.418||0.2615||95.0|-5.628|20.224|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||20.224|-5.628|0.2615
71042706|NCT00442546|141594094|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.286|STANDARD_ERROR_OF_MEAN|6.707||0.6266||95.0|-10.22|16.795|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||16.795|-10.22|0.6266
71042707|NCT00442546|141594094|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.17|STANDARD_ERROR_OF_MEAN|3.958||0.2963||95.0|-3.747|12.086|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||12.086|-3.747|0.2963
71042708|NCT00442546|141594094|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.248|STANDARD_ERROR_OF_MEAN|4.151||0.1375||95.0|-2.054|14.55|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||14.550|-2.054|0.1375
71042709|NCT00442546|141594094|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.431|STANDARD_ERROR_OF_MEAN|4.895||0.2703||95.0|-4.298|15.161|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||15.161|-4.298|0.2703
71042710|NCT00442546|141594094|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.663|STANDARD_ERROR_OF_MEAN|4.664||0.104||95.0|-1.607|16.933|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||16.933|-1.607|0.1040
71042711|NCT00442546|141594095|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.579|STANDARD_ERROR_OF_MEAN|3.154||0.8545||95.0|-5.635|6.793|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||6.793|-5.635|0.8545
71042712|NCT00442546|141594095|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.128|STANDARD_ERROR_OF_MEAN|3.155||0.5006||95.0|-4.088|8.344|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||8.344|-4.088|0.5006
71042713|NCT00442546|141594095|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.956|STANDARD_ERROR_OF_MEAN|8.248||0.7217||95.0|-13.66|19.569|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||19.569|-13.66|0.7217
71042714|NCT00442546|141594095|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.011|STANDARD_ERROR_OF_MEAN|8.62||0.4203||95.0|-10.35|24.372|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||24.372|-10.35|0.4203
71001791|NCT00937326|141511055|SUPERIORITY|||||||0.699||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 28 for fructosamine.||||0.699
71001792|NCT00937326|141511055|SUPERIORITY|||||||0.313||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 28 for fructosamine.||||0.313
71001793|NCT00937326|141511056|SUPERIORITY|||||||0.896||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.896
71001794|NCT00937326|141511056|SUPERIORITY|||||||0.08||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.080
71001795|NCT00937326|141511056|SUPERIORITY|||||||0.792||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.792
71001796|NCT00937326|141511056|SUPERIORITY|||||||0.645||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.645
71001797|NCT00937326|141511057|SUPERIORITY|||||||0.992||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 1 for HOMA-IR.||||0.992
71001798|NCT00937326|141511057|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 1 for HOMA-IR.||||0.999
71001799|NCT00937326|141511057|SUPERIORITY|||||||0.548||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 1 for HOMA-IR.||||0.548
71001800|NCT00937326|141511057|SUPERIORITY|||||||0.989||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 1 for HOMA-IR.||||0.989
71001801|NCT00937326|141511057|SUPERIORITY|||||||0.877||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 28 for HOMA-IR.||||0.877
71001802|NCT00937326|141511057|SUPERIORITY|||||||0.887||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 28 for HOMA-IR.||||0.887
71001803|NCT00937326|141511057|SUPERIORITY|||||||0.916||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 28 for HOMA-IR.||||0.916
71001804|NCT00937326|141511057|SUPERIORITY|||||||0.86||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 28 for HOMA-IR.||||0.860
71001805|NCT00937326|141511058|SUPERIORITY|||||||0.996||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.996
71001806|NCT00937326|141511058|SUPERIORITY|||||||0.989||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.989
71001807|NCT00937326|141511058|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.999
71042715|NCT00442546|141594095|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|5.6||0.9859||95.0|-11.3|11.102|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||11.102|-11.30|0.9859
71001808|NCT00937326|141511058|SUPERIORITY|||||||0.763||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.763
71100743|NCT02732145|141709686|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Meatus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Urethral meatus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
71001809|NCT00937326|141511059|SUPERIORITY|||||||0.81||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 1 for HOMA-percentage of beta cell function.||||0.810
71001810|NCT00937326|141511059|SUPERIORITY|||||||0.753||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 1 for HOMA-percentage of beta cell function.||||0.753
71001811|NCT00937326|141511059|SUPERIORITY|||||||0.404||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 1 for HOMA-percentage of beta cell function.||||0.404
71001812|NCT00937326|141511059|SUPERIORITY|||||||0.671||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 1 for HOMA-percentage of beta cell function.||||0.671
71001813|NCT00937326|141511059|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 28 for HOMA-percentage of beta cell function.||||1.000
71042716|NCT00442546|141594095|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|5.873||0.9915||95.0|-11.68|11.811|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||11.811|-11.68|0.9915
71042717|NCT00442546|141594095|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.128|STANDARD_ERROR_OF_MEAN|6.508||0.9843||95.0|-13.06|12.808|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||12.808|-13.06|0.9843
71042718|NCT00442546|141594095|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.351|STANDARD_ERROR_OF_MEAN|6.201||0.7055||95.0|-9.974|14.677|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||14.677|-9.974|0.7055
71042719|NCT00442546|141594096|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.315||0.9405||95.0|-0.614|0.661|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.661|-0.614|0.9405
71001814|NCT00937326|141511059|SUPERIORITY|||||||0.622||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 28 for HOMA-percentage of beta cell function.||||0.622
71001815|NCT00937326|141511059|SUPERIORITY|||||||0.332||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 28 for HOMA-percentage of beta cell function.||||0.332
71001816|NCT00937326|141511059|SUPERIORITY|||||||0.998||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 28 for HOMA-percentage of beta cell function.||||0.998
71001817|NCT00937326|141511060|SUPERIORITY|||||||0.994||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.994
71001818|NCT00937326|141511060|SUPERIORITY|||||||0.979||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.979
71001819|NCT00937326|141511060|SUPERIORITY|||||||0.993||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.993
71042720|NCT00442546|141594096|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.167|STANDARD_ERROR_OF_MEAN|0.287||0.5641||95.0|-0.749|0.415|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.415|-0.749|0.5641
71042721|NCT00442546|141594096|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.755||0.5226||95.0|-1.181|2.181|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||2.181|-1.181|0.5226
71100744|NCT02732145|141709686|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of Hymenal Remnants among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Hymenal Remnants in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
71100745|NCT02732145|141709686|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of Bartholin's Gland Opening among the patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Bartholin's Gland Opening in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
71100746|NCT02732145|141709686|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of the Vestibule among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Vestibule in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
71100747|NCT02732145|141709686|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of the Clitoris among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Clitoris in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
71100748|NCT02732145|141709686|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of Hart's Line among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Hart's Line in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
71001820|NCT00937326|141511060|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.999
71001821|NCT02037204|141511135|NON_INFERIORITY|A repeated-measures analysis of variance was used to test for differences in clinical outcome between baseline and 3, and 18 months after surgery.|||||<|0.05|||||||ANOVA|||A repeated-measures analysis of variance was used to test for differences in clinical outcome between baseline and 3, and 18 months after surgery.||||<0.05
71001822|NCT00927576|141511158|NON_INFERIORITY_OR_EQUIVALENCE|Power analysis of the results showed a 95% chance of finding a p\<0.05 difference in 166 subjects and a 99% chance of finding a p \<0.05 difference in 230 subjects in comparison of Group 1 controls and sTBI patients.|Difference in z-score, sTBI vs. controls|2.04|||<|0.001|TWO_SIDED||||||ANOVA|for repeated measures with effect sizes (omega squared).||The null hypotheses was that the severe TBI group would not differ from the control group in SRT latencies.||||< 0.001
71001823|NCT00927576|141511158|NON_INFERIORITY_OR_EQUIVALENCE|Power analysis of controls (i.e., with z-score = 0) showed a 95% chance of detecting a p \< 0.05 significance level for z-scores exceeding 0.54 in the mild TBI patient group..|z-score difference between groups|-0.3||||0.5|TWO_SIDED|||||The P-value reflects the likelihood of detection a difference of the magnitude observed.|ANOVA|||The null hypothesis was that the mild TBI group would not differ in age-corrected z-score from that of a control subjects in the large control group.||||.50
71001824|NCT02019758|141511174|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||The mean post-treatment maximum eosinophil count will be compared between the OVB and MDI groups using a two-sample t-test.||||0.31
71001825|NCT02019758|141511175|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||The mean DSQ scores will be compared between the OVB and MDI groups using a two-sample t-test.||||0.70
71001826|NCT02019758|141511180|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.52|2.08||||||||2.08|0.52|
71001827|NCT02019758|141511181|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71001828|NCT02019758|141511182|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71001829|NCT02019758|141511183|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71001830|NCT04882072|141511198|SUPERIORITY||Hazard Ratio (HR)|1.86|||||TWO_SIDED|95.0|0.41|8.47||||||||8.47|0.41|
71001831|NCT02918318|141511219|SUPERIORITY||Difference of Least Squares means|-1.0|STANDARD_ERROR_OF_MEAN|2.25||0.475|TWO_SIDED|90.0|-5.77|3.7||1-sided|Dunnett adjustment|||||3.70|-5.77|0.475
71001832|NCT02918318|141511219|SUPERIORITY||Difference of Least Squares means|0.6|STANDARD_ERROR_OF_MEAN|2.33||0.504|TWO_SIDED|90.0|-4.32|5.47||1-sided|Dunnett adjustment|||||5.47|-4.32|0.504
71001833|NCT02918318|141511219|SUPERIORITY||Difference of Least Squares means|-0.9|STANDARD_ERROR_OF_MEAN|2.26||0.482|TWO_SIDED|90.0|-5.66|3.83||1-sided|Dunnett adjustment|||||3.83|-5.66|0.482
71001834|NCT05103475|141511233|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||1||||||The investigators used Fisher's exact due to small cell sizes.|Fisher Exact|The reported value represents the calculated p-value for the Fisher's Exact test.||||||1.0
71001835|NCT05103475|141511234|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.35|||||||t-test, 2 sided|||||||0.35
71001836|NCT05103475|141511235|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.15||||||The investigators used Fisher's Exact due to small cell sizes.|Fisher Exact|||||||0.15
71001837|NCT05103475|141511236|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.43|||||||t-test, 2 sided|||Pre/post comparison for control group scores.||||0.43
71001838|NCT05103475|141511236|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.24|||||||t-test, 2 sided|||Pre/post comparison for RAP group score.||||0.24
71100749|NCT02732145|141709686|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of the Urethral Sulcus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Urethral Sulcus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
71001839|NCT05103475|141511236|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.53||||||F = 0.41|ANOVA|||ANOVA results - group x time interaction.||||0.53
71001840|NCT05103475|141511237|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.7|||||||t-test, 2 sided|||Pre/post comparison for control group.||||0.70
71001841|NCT05103475|141511237|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.17|||||||t-test, 2 sided|||Pre/post comparison for RAP group.||||0.17
71001842|NCT05103475|141511237|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.18||||||F = 1.95|ANOVA|||ANOVA results - group x time interaction.||||0.18
71001843|NCT05103475|141511238|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.37|||||||t-test, 2 sided|||Pre/post comparison - control group.||||0.37
71001844|NCT05103475|141511238|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.5|||||||t-test, 2 sided|||Pre/post comparison - RAP group.||||0.50
71001845|NCT05103475|141511238|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.9||||||F = 0.01|ANOVA|||ANOVA results - group x time interaction.||||0.90
71001846|NCT05103475|141511239|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.56|||||||t-test, 2 sided|||Pre/post comparison - control group.||||0.56
71001847|NCT05103475|141511239|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.32|||||||t-test, 2 sided|||Pre/post comparison - RAP group.||||0.32
71001848|NCT05103475|141511239|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.41||||||F = 0.71|ANOVA|||ANOVA results - group x time interaction.||||0.41
71001849|NCT05103475|141511240|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.5|||||||t-test, 2 sided|||Pre/post comparison - control group.||||0.50
71001850|NCT05103475|141511240|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.6|||||||t-test, 2 sided|||Pre/post comparison - RAP group.||||0.60
71001851|NCT05103475|141511240|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.98||||||F = 0.0|ANOVA|||ANOVA results - group x time interaction.||||0.98
71001852|NCT05103475|141511241|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.54|||||||t-test, 2 sided|||Pre/post comparison - control group.||||0.54
71001853|NCT05103475|141511241|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.15|||||||t-test, 2 sided|||Pre/post comparison - RAP group.||||0.15
71001854|NCT05103475|141511241|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.04||||||F = 4.9|ANOVA|||ANOVA results - group x time interaction.||||0.04
71001855|NCT05103475|141511242|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.11|||||||t-test, 2 sided|||Pre/post comparison - control group.||||0.11
71001856|NCT05103475|141511242|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.09|||||||t-test, 2 sided|||Pre/post comparison - RAP group.||||0.09
71001857|NCT05103475|141511242|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.75||||||F = 0.10|ANOVA|||ANOVA results - group x time interaction.||||0.75
71001858|NCT05103475|141511243|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.41|||||||Fisher Exact|The investigators used Fisher's Exact due to small cell sizes.||Likelihood to participate in a program like it in the future||||0.41
71001859|NCT05103475|141511243|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.003||||||The investigators used Fisher's Exact due to small cell sizes.|Fisher Exact|||Help to manage back pain.||||0.003
71001860|NCT05103475|141511243|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||1||||||The investigators used Fisher's Exact due to small sample sizes.|Fisher Exact|The reported value represents the calculated p-value for the Fisher's Exact test.||Would recommend to another Veteran.||||1.00
71001861|NCT05103475|141511243|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.07||||||The investigators used Fisher's Exact due to small cell sizes.|Fisher Exact|||Liked the program.||||0.07
70924286|NCT03761537|141340961|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Difference|-8.6|||<|0.001|TWO_SIDED|95.0|-13.0|-4.2||This was the third endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Repeated measurements model|Treatment effect at each visit adjusted for baseline SCORAD interacting with each visit, prior CSA, and baseline disease severity (IGA 3 or 4).||Data collected after permanent discontinuation of IMP, after initiation of rescue treatment, or after subject-onset of the COVID-19 pandemic will not be included in the analysis.||-4.2|-13.0|<0.001
71001862|NCT05103475|141511244|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.91|||||||t-test, 2 sided|||Pre/post comparison - control group.||||0.91
71001863|NCT05103475|141511244|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.51|||||||t-test, 2 sided|||Pre/post comparison - RAP group.||||0.51
71001864|NCT05103475|141511244|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.42||||||F = 0.68|ANOVA|||ANOVA results - group x time interaction.||||0.42
71001865|NCT02023112|141511253|SUPERIORITY_OR_OTHER_LEGACY||percentage of participants with SVR12|91.5|||||TWO_SIDED|95.0|80.1|96.6|||||Tested using the following hierarchical order: among non-cirrhotic treatment-naïve participants 1) superiority of 16-week treatment arm to a clinically relevant threshold; 2) superiority of 12-week treatment arm to a clinically relevant threshold.|"Among non-cirrhotic treatment-naïve participants, superiority of the 16-week treatment arm to a clinically relevant threshold.~Lower bound of 95% confidence interval (LCB) must have exceeded 67% to achieve superiority. Threshold indicates value the LCB had to exceed to demonstrate superiority for the treatment arm and was based on the SVR rates with pegylated-interferon (IFN) alfa-2a or 2b/RBV in treatment-naïve, noncirrhotic HCV genotype 2-infected participants."||96.6|80.1|
71001866|NCT02023112|141511253|SUPERIORITY_OR_OTHER_LEGACY||percentage of participants with SVR12|75.0|||||TWO_SIDED|95.0|61.2|85.1|||||Tested using the following hierarchical order: among non-cirrhotic treatment-naïve participants 1) superiority of 16-week treatment arm to a clinically relevant threshold; 2) superiority of 12-week treatment arm to a clinically relevant threshold.|"Among non-cirrhotic treatment-naïve participants, superiority of the 12-week treatment arm to a clinically relevant threshold.~LCB must have exceeded 67% to achieve superiority. Threshold indicates value the LCB had to exceed to demonstrate superiority for the treatment arm and was based on the SVR rates with pegylated-IFN alfa-2a or 2b/RBV in treatment-naïve, noncirrhotic HCV genotype 2-infected participants."||85.1|61.2|
71001867|NCT03536923|141511259|OTHER|||||||0.0001|||||||t-test, 1 sided|||||||0.0001
71001868|NCT03536923|141511260|OTHER|||||||0.0009|||||||t-test, 1 sided|||||||0.0009
71001869|NCT03536923|141511262|OTHER|||||||0.0001|||||||t-test, 1 sided|||||||0.0001
71001870|NCT02228824|141511263|SUPERIORITY||Mean Difference (Final Values)|1.51|||<|0.001|TWO_SIDED|95.0|0.86|2.17|||ANCOVA|ANCOVA was performed on 25 sets of imputed data and then analyzed using SAS PROC MIANALYZE||||2.17|0.86|<0.001
71001871|NCT02228824|141511265|SUPERIORITY||Mean Difference (Final Values)|-38.5||||0.041|TWO_SIDED|95.0|-75.21|-1.78|||Mixed Models Analysis|||||-1.78|-75.21|0.041
71001872|NCT02228824|141511266|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.016|TWO_SIDED|95.0|-1.26|-0.13|||ANCOVA|ANCOVA was performed on 25 sets of imputed data and then analyzed using SAS PROC MIANALYZE||||-0.13|-1.26|0.016
71001873|NCT02228824|141511267|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.03|TWO_SIDED|95.0|-0.04|-0.002|||Mixed Models Analysis|||||-0.002|-0.04|0.03
71001874|NCT01906476|141511268|NON_INFERIORITY|Non-inferiority trials of pharmaceuticals have used 30% to 50% of the difference between treatment and control conditions to define non-inferiority margins. (Jones, Jarvis, Lewis, \& Ebbutt, 1996; Nutt et al., 2008). A meta-analysis of CBT found an overall effect size of d=0.82.(Cuijpers, Smit, Bohlmeijer, Hollon, \& Andersson, 2010). Using the midpoint of 40% for the acceptable criterion, we set d=0.33 as the non-inferiority criterion.|||||||||||||||||"Cohen's d and upper limits of one-sided 95% Confidence intervals for each time are as follows:~Mid-treatment -0.19 (95% upper limit= 0.06) End of treatment 0.03 (0.24) 3 months post treatment -0.02 (0.19) 6 months post treatment -0.07 (0.14)"|||
71001875|NCT01906476|141511269|SUPERIORITY||ICER estimate|-152.55|||||TWO_SIDED|95.0|-1143.09|1094.72||||||We calculated the ICER (Incremental cost-effectiveness ratio) estimate, computed using the difference in average cost between the two arms, divided by the difference in average Depression Free Days (DFD) as defined using QIDS (Quick Inventory of Depressive Symptomatology), between the two arms, Stepped Care minus Telephone Cognitive Behavior Therapy. The confidence interval was created using bootstrapping.||1094.72|-1143.09|
71001876|NCT01176240|141511270|SUPERIORITY_OR_OTHER|||||||0.978|||||||ANCOVA|ANCOVA model that includes treatment as a factor and baseline OHQ composite score as a co-variate.||Study 306A was initially designed as a blinded interim analysis by an independent DMC to ensure that the overall study was adequately powered. Study 306A was not powered to provide statistical significance as a stand alone study. Thus, no additional efficacy end points were prospectively defined beyond the primary end point.||||0.978
71001877|NCT01176240|141511271|SUPERIORITY_OR_OTHER|||||||0.018||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at baseline.||||||0.018
71001878|NCT01176240|141511273|SUPERIORITY_OR_OTHER|||||||0.6||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors. As the first secondary endpoint was not positive, statistical analysis was not performed on additional secondary endpoints.|Wilcoxon (Mann-Whitney)|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at baseline.||||||0.60
71001879|NCT01176240|141511279|SUPERIORITY_OR_OTHER|||||||0.238|||||||ANCOVA|ANCOVA model that includes treatment as a factor and baseline OHQ composite score as a co-variate.||||||0.238
71001880|NCT02896192|141511286|OTHER||CI||||<|0.0001||||||One-sided p-value obtained from exact binomial test, testing that at least 5% of participants in the population of interest would achieve 10% weight loss.|Exact binomial test|||||||<0.0001
71001881|NCT02896192|141511287|OTHER||||||<|0.0001||||||One-sided p-value obtained from exact binomial test, testing that at least 5% of participants in the population of interest would achieve 10% weight loss.|Exact binomial test|||||||<0.0001
71001882|NCT02896192|141511288|OTHER||Least Squares Mean|-25.73|||<|0.0001|TWO_SIDED|90.0|-28.49|-22.98|||Longitudinal mixed analysis of variance|||Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for visit, baseline body weight and random effect for participant, one sided p-value from model.||-22.98|-28.49|<0.0001
71001883|NCT02896192|141511289|OTHER||Least Squares Mean|-27.77||||0.0005|TWO_SIDED|90.0|-40.58|-14.96|||Longitudinal mixed analysis of variance|||Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for week, baseline daily hunger score and random effect for participant, one sided p-value from model.||-14.96|-40.58|0.0005
71001884|NCT02896192|141511290|OTHER|||||||0.0004||||||One-sided p-value obtained from exact binomial test, testing that ≥ 5% of participants in the population of interest would achieve ≥ 25% improvement in daily hunger score.|Exact binomial test|||||||0.0004
71001885|NCT02896192|141511291|OTHER||Least Squares Mean|-18.1|||<|0.0001|TWO_SIDED|90.0|-21.27|-14.88|||Longitudinal mixed analysis of variance|||Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for visit, baseline waist circumference and random effect for participant, one sided p-value from model.||-14.88|-21.27|<0.0001
71001886|NCT02896192|141511294|OTHER||Least Squares Mean|-27.4|||<|0.0001|TWO_SIDED|90.0|-30.6|-24.29|||Longitudinal mixed analysis of variance|||Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for week, baseline BMI and random effect for participant, one sided p-value from model.||-24.29|-30.60|<0.0001
71001887|NCT00118404|141511324|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.079|STANDARD_ERROR_OF_MEAN|0.39||0.42|TWO_SIDED|95.0|0.5|2.34|||Log Rank|log-rank chi-square = 0.038, df = 1, p \<=.42|Hazard ratio for relapse in C-CT group compared to that in the fluoxetine group.|The sample size was based on a predicted 30% difference in relapse/recurrence rates between C-CT and fluoxetine (ie,30% vs 60%) across both the experimental phase and the first 12 months of follow-up. With these assumptions, 180 randomized patients (60 per cell) were required to detect a statistically significant difference using a log-rank test with 1-sided α = 0.05 and 80% power.||2.34|0.50|.42
71001888|NCT00118404|141511324|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.481|STANDARD_ERROR_OF_MEAN|0.38||0.02|TWO_SIDED|95.0|0.23|1.01|||Log Rank|log-rank chi-square = 3.92, df = 1|Hazard Ratio for relapse in fluoxetine group compared to that in the pill placebo group.|||1.01|.23|.02
71001889|NCT00118404|141511324|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.519|STANDARD_ERROR_OF_MEAN|0.36||0.03|TWO_SIDED|95.0|0.26|1.06|||Log Rank|log-rank chi-square = 3.391, df = 1|Hazard ratio for relapse in C-CT group compared to that in the placebo group.|||1.06|0.26|.03
71001890|NCT00118404|141511324|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.501|STANDARD_ERROR_OF_MEAN|0.31||0.01|TWO_SIDED|95.0|0.27|0.93|||Log Rank|log-rank chi-square = 5.06, df = 1|Hazard ratio for relapse in active treatment group (fluoxetine or C-CT) compared to that in the placebo group.|||0.93|0.27|.01
71001891|NCT00118404|141511325|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.988|STANDARD_ERROR_OF_MEAN|0.3||0.48|TWO_SIDED|95.0|0.55|1.76|||Log Rank|log-rank chi-square = 0.002, df = 1|Hazard ratio for relapse/recurrence in the C-CT group compared to that in the fluoxetine group.|||1.76|0.55|.48
71001892|NCT00118404|141511325|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.717|STANDARD_ERROR_OF_MEAN|0.31||0.14|TWO_SIDED|95.0|0.39|1.31|||Log Rank|Chi-square = 1.19, df = 1|Hazard ratio of relapse/recurrence in the Fluoxetine arm over the 20 months of follow-up since randomization compared to the pill placebo arm.|||1.31|.39|.14
71042722|NCT00442546|141594096|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.167|STANDARD_ERROR_OF_MEAN|0.893||0.8557||95.0|-2.156|1.823|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||1.823|-2.156|0.8557
71001893|NCT00118404|141511325|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.715|STANDARD_ERROR_OF_MEAN|0.3||0.13|TWO_SIDED|95.0|0.4|1.29|||Log Rank|chi-square = 1.262, df = 1|Hazard ratio of relapse/recurrence in the C-CT arm over the 20 months of follow-up since randomization compared to the pill placebo arm.|||1.29|.40|.13
71001894|NCT00118404|141511325|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.717|STANDARD_ERROR_OF_MEAN|0.26||0.1|TWO_SIDED|95.0|0.43|1.2|||Log Rank|Chi-square = 1.595, df = 1|Hazard of relapse/recurrence in the active treatment (FLX or C-CT) arm compared to PBO (placebo)arm.|||1.20|.43|.10
71001895|NCT00118404|141511326|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.075|STANDARD_ERROR_OF_MEAN|0.27||0.4|TWO_SIDED|95.0|0.63|1.84|||Log Rank|chi-square = .07, df = 1|Hazard of relapse/recurrence for C-CT arm compared to FLX arm was reported.|||1.84|.63|.40
71042723|NCT00442546|141594096|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.328|STANDARD_ERROR_OF_MEAN|0.882||0.1925||95.0|-3.596|0.94|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.940|-3.596|0.1925
71001896|NCT00118404|141511326|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.649|STANDARD_ERROR_OF_MEAN|0.28||0.61|TWO_SIDED|95.0|0.37|1.13|||Log Rank|chi-square = 2.407, df = 1|Hazard of relapse/recurrence in the FLX arm compared tp C-CT arm was reported.|||1.13|.37|.61
71001897|NCT00118404|141511326|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.701|STANDARD_ERROR_OF_MEAN|0.27||0.09|TWO_SIDED|95.0|0.41|1.19|||Log Rank|chi-square = 1.731, df = 1|Hazard of relapse/recurrence in the C-CT arm compared to PBO arm is reported.|||1.19|.41|.09
71001898|NCT00118404|141511326|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.676|STANDARD_ERROR_OF_MEAN|0.24||0.05|TWO_SIDED|95.0|0.42|1.08|||Log Rank|chi-square = 2.705, df = 1|Hazard of relapse/recurrence in the active treatment (FLX or C-CT) arm compared to PBO arm was reported.|||1.08|.42|.05
71001899|NCT00807014|141511327|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Analysis of covariance (ANCOVA) model was used with terms for baseline value, treatment, and center. Treatment-by-center interaction was not included.|ANCOVA|||||||<0.001
71001900|NCT01628042|141511343|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.83|||||TWO_SIDED|90.0|1.36|2.46|||ANCOVA|||||2.46|1.36|
71001901|NCT01628042|141511343|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|2.06|||||TWO_SIDED|90.0|1.55|2.74|||ANCOVA|||||2.74|1.55|
71001902|NCT01628042|141511343|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.49|||||TWO_SIDED|90.0|1.11|2.0|||ANCOVA|||||2.00|1.11|
71001903|NCT01628042|141511344|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.42|||||TWO_SIDED|90.0|0.89|2.27|||ANCOVA|||||2.27|0.89|
71001904|NCT01628042|141511344|SUPERIORITY_OR_OTHER||Geometric least-squares mean ration|1.68|||||TWO_SIDED|90.0|1.07|2.63|||ANCOVA|||||2.63|1.07|
71042724|NCT00442546|141594096|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.982||0.9654||95.0|-2.568|2.479|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||2.479|-2.568|0.9654
71042725|NCT00442546|141594096|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.352|STANDARD_ERROR_OF_MEAN|1.782||0.235||95.0|-6.712|2.008|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||2.008|-6.712|0.2350
71042726|NCT00442546|141594096|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.296|STANDARD_ERROR_OF_MEAN|0.859||0.742||95.0|-1.806|2.399|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||2.399|-1.806|0.7420
71001905|NCT01628042|141511344|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.96|||||TWO_SIDED|90.0|1.23|3.13|||ANCOVA|||||3.13|1.23|
71001906|NCT01628042|141511345|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|0.55|||||TWO_SIDED|90.0|0.41|0.74|||ANCOVA|||||0.74|0.41|
71001907|NCT01628042|141511345|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|0.49|||||TWO_SIDED|90.0|0.36|0.65|||ANCOVA|||||0.65|0.36|
71001908|NCT01628042|141511345|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|0.67|||||TWO_SIDED|90.0|0.5|0.9|||ANCOVA|||||0.90|0.50|
71001909|NCT01696396|141511363|SUPERIORITY|The study was powered for formal statistical testing of the abrilumab 70 mg group. The primary and key secondary endpoints were tested under a sequential framework of statistical hypotheses, each with 2-sided significance level of 0.10 for the treatment effect of abrilumab 70 mg compared with placebo.|Odds Ratio (OR)|1.15||||0.76|TWO_SIDED|90.0|0.54|2.44|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||2.44|0.54|0.76
71001910|NCT01696396|141511363|SUPERIORITY||Difference in Adjusted Remission Rates|1.6|||||TWO_SIDED|90.0|-7.9|8.9||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||8.9|-7.9|
71001911|NCT01696396|141511363|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|1.91||||0.22|TWO_SIDED|90.0|0.8|4.57|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.57|0.80|0.22
71001912|NCT01696396|141511363|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|9.1|||||TWO_SIDED|90.0|-4.6|19.4||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||19.4|-4.6|
71001913|NCT01696396|141511363|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|2.05||||0.25|TWO_SIDED|90.0|0.74|5.73|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||5.73|0.74|0.25
71001914|NCT01696396|141511363|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|10.3|||||TWO_SIDED|90.0|-6.8|22.6||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||22.6|-6.8|
71001915|NCT01696396|141511364|SUPERIORITY||Odds Ratio (OR)|1.78||||0.16|TWO_SIDED|90.0|0.9|3.53|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.53|0.90|0.16
71001916|NCT01696396|141511364|SUPERIORITY||Difference in Adjusted Remission Rates|10.9|||||TWO_SIDED|90.0|-1.8|21.0||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||21.0|-1.8|
71042727|NCT00442546|141594097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.208|STANDARD_ERROR_OF_MEAN|0.329||0.5299||95.0|-0.458|0.874|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.874|-0.458|0.5299
71042728|NCT00442546|141594097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.355|STANDARD_ERROR_OF_MEAN|0.3||0.2442||95.0|-0.964|0.253|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.253|-0.964|0.2442
71042729|NCT00442546|141594097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.755||0.5226||95.0|-1.181|2.181|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||2.181|-1.181|0.5226
71042730|NCT00442546|141594097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.167|STANDARD_ERROR_OF_MEAN|0.893||0.8557||95.0|-2.156|1.823|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||1.823|-2.156|0.8557
71042731|NCT00442546|141594097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.119|STANDARD_ERROR_OF_MEAN|1.024||0.324||95.0|-3.751|1.512|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||1.512|-3.751|0.3240
71042732|NCT00442546|141594097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|1.139||0.9503||95.0|-2.853|3.003|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||3.003|-2.853|0.9503
71042733|NCT00442546|141594097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.833|STANDARD_ERROR_OF_MEAN|1.858||0.3618||95.0|-6.379|2.712|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||2.712|-6.379|0.3618
71001917|NCT01696396|141511364|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|2.12||||0.13|TWO_SIDED|90.0|0.93|4.84|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.84|0.93|0.13
71001918|NCT01696396|141511364|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|14.7|||||TWO_SIDED|90.0|-2.1|27.5||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||27.5|-2.1|
71042734|NCT00442546|141594097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.333|STANDARD_ERROR_OF_MEAN|0.896||0.7226||95.0|-1.859|2.525|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||2.525|-1.859|0.7226
71042735|NCT00442546|141594098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2473||95.0|||||Cochran-Mantel-Haenszel|||Discharge||||0.2473
71042736|NCT00442546|141594098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0239||95.0|||||Cochran-Mantel-Haenszel|||Discharge||||0.0239
71042737|NCT00442546|141594098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6118||95.0|||||Cochran-Mantel-Haenszel|||Week 2||||0.6118
71042738|NCT00442546|141594098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.673||95.0|||||Cochran-Mantel-Haenszel|||Week 2||||0.6730
71042739|NCT00442546|141594098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5954||95.0|||||Cochran-Mantel-Haenszel|||Week 4||||0.5954
71001919|NCT01696396|141511364|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|3.1||||0.056|TWO_SIDED|90.0|1.17|8.2|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||8.20|1.17|0.056
71001920|NCT01696396|141511364|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|23.7|||||TWO_SIDED|90.0|2.8|39.2||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||39.2|2.8|
71042740|NCT00442546|141594098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7784||95.0|||||Cochran-Mantel-Haenszel|||Week 4||||0.7784
71042741|NCT00442546|141594098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7293||95.0|||||Cochran-Mantel-Haenszel|||Week 6/ET||||0.7293
71042742|NCT00442546|141594098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5202||95.0|||||Cochran-Mantel-Haenszel|||Week 6/ET||||0.5202
71042743|NCT00442546|141594099|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1509||95.0|||||Cochran-Mantel-Haenszel|||Month 3||||0.1509
71042744|NCT00442546|141594099|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3822||95.0|||||Cochran-Mantel-Haenszel|||Month 3||||0.3822
71042745|NCT00442546|141594099|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2825||95.0|||||Cochran-Mantel-Haenszel|||Month 6||||0.2825
71042746|NCT00442546|141594099|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7733||95.0|||||Cochran-Mantel-Haenszel|||Month 6||||0.7733
71042747|NCT02000531|141594122|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26|||>|0.05|TWO_SIDED|95.0|0.61|2.62|||Log Rank|||||2.62|0.61|>0.05
71042748|NCT01239472|141594130|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71042749|NCT01239472|141594131|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71042750|NCT01280617|141594140|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|Continuous variables analyzed using 2-tailed t test or Mann Whitney tes.. Categorical variables analyzed using Chi-Square or Fisher's Exact test||||||<0.05
71042751|NCT01280617|141594140|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71042752|NCT05966090|141594142|NON_INFERIORITY|Non - Inferiority (NI) was to be demonstrated if the upper limit of the 2 sided 95% confidence interval (CI) of the GMC ratio between the Control group (at Day 91) versus Co-administration group (at Day 91) for anti-gE Ab 1-month after the second HZ/su vaccine dose was \<=1.5.|Ratio|1.24|||||TWO_SIDED|95.0|1.08|1.42|||||The analysis of covariance (ANCOVA) model, for logarithm-transformed concentration, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as a covariate.|To demonstrate non-inferiority of the humoral immune response to 2 doses of HZ/su vaccine when the first dose of HZ/su vaccine was co-administered with RSVPreF3 OA investigational vaccine, compared to 2 doses of HZ/su vaccine administered alone.||1.42|1.08|
71042753|NCT05966090|141594143|NON_INFERIORITY|NI was to be demonstrated if upper limit of the 2 sided 95% CI of the GMT ratio between the Control group (at Day 61) versus Co-administration group (at Day 31) for RSV-A neutralizing titer 1-month after the RSVPreF3 OA investigational vaccine dose was \<=1.5|ratio|1.14|||||TWO_SIDED|95.0|0.97|1.35|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as a covariate.|To demonstrate the non-inferiority of RSVPreF3 OA investigational vaccine when co-administered with the first dose of HZ/su vaccine, compared to RSVPreF3 OA investigational vaccine administered alone.||1.35|0.97|
71042754|NCT05966090|141594144|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2 sided 95% CI of the GMT ratio between the Control group (at Day 61) versus Co-administration group (at Day 31) for RSV-B neutralizing titer 1-month after the RSVPreF3 OA investigational vaccine dose was \<=1.5.|ratio|0.98|||||TWO_SIDED|95.0|0.84|1.15|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as a covariate.|To demonstrate the non-inferiority of RSVPreF3 OA investigational vaccine when co-administered with the first dose of HZ/su vaccine, compared to RSVPreF3 OA investigational vaccine administered alone.||1.15|0.84|
71042755|NCT03460158|141594167|OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.1524||0.8822|TWO_SIDED|95.0|||||t-test, 2 sided|||Two-sample t test with equal variances the null hypothesis is the relative change in volume and relative change in patient reported outcomes will be the same at 2 weeks post injection||||0.8822
71042756|NCT03460158|141594167|OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.1466||0.2223|TWO_SIDED|95.0|||||t-test, 2 sided|||Two-sample t test with equal variances the null hypothesis is the change in volume and change in patient reported outcomes will be the same at 4 weeks post injection||||0.2223
70924287|NCT03761537|141340962|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Difference|-1.5||||0.009|TWO_SIDED|95.0|-2.6|-0.4||This was the fourth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Repeated measurements model|Treatment effect at each visit adjusted for baseline DLQI interacting with each visit, prior CSA, and baseline disease severity (IGA 3 or 4).||Data collected after permanent discontinuation of IMP, after initiation of rescue treatment, or after subject-onset of the COVID-19 pandemic will not be included in the analysis.||-0.4|-2.6|0.009
71001921|NCT01696396|141511365|SUPERIORITY||Odds Ratio (OR)|2.25||||0.021|TWO_SIDED|90.0|1.27|4.01|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.01|1.27|0.021
71001922|NCT01696396|141511365|SUPERIORITY||Difference in Adjusted Response Rates|19.8|||||TWO_SIDED|90.0|5.8|31.3||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||31.3|5.8|
71001923|NCT01696396|141511365|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|1.9||||0.14|TWO_SIDED|90.0|0.94|3.87|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.87|0.94|0.14
71001924|NCT01696396|141511365|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Response Rates|15.7|||||TWO_SIDED|90.0|-2.3|29.7||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||29.7|-2.3|
71001925|NCT01696396|141511365|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|1.87||||0.23|TWO_SIDED|90.0|0.79|4.39|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.39|0.79|0.23
71001926|NCT01696396|141511365|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Response Rates|15.1|||||TWO_SIDED|90.0|-6.4|31.3||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||31.3|-6.4|
71001927|NCT01696396|141511366|SUPERIORITY||Odds Ratio (OR)|1.98||||0.047|TWO_SIDED|90.0|1.13|3.47|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.47|1.13|0.047
71001928|NCT01696396|141511366|SUPERIORITY||Difference in Adjusted Response Rates|16.0|||||TWO_SIDED|90.0|2.4|27.1||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||27.1|2.4|
71042757|NCT03460158|141594167|OTHER||Mean Difference (Final Values)|-0.369|STANDARD_ERROR_OF_MEAN|0.113||0.0015|TWO_SIDED|95.0|||||t-test, 2 sided|||Two-sample t test with equal variances the null hypothesis is the change in volume and change in patient reported outcomes will be the same at 12 weeks post injection||||0.0015
71001929|NCT01696396|141511366|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|1.09||||0.84|TWO_SIDED|90.0|0.52|2.29|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||2.29|0.52|0.84
71001930|NCT01696396|141511366|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Response Rates|1.9|||||TWO_SIDED|90.0|-15.2|15.2||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||15.2|-15.2|
71001931|NCT01696396|141511366|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|1.15||||0.78|TWO_SIDED|90.0|0.49|2.72|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||2.72|0.49|0.78
71001932|NCT01696396|141511366|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Response Rates|3.1|||||TWO_SIDED|90.0|-17.4|18.3||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||18.3|-17.4|
71042758|NCT01098110|141594177|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-11.29|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001|TWO_SIDED|95.0|-15.42|-7.16||Statistical significant: p=\<0.05, two sided|ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-7.16|-15.42|<0.0001
70924288|NCT03761537|141340963|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Risk Difference (RD)|15.6||||0.005|TWO_SIDED|95.0|4.8|26.3||This endpoint was the fifth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Mantel Haenszel|Mantel-Haenszel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.||Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.||26.3|4.8|0.005
70924289|NCT03761537|141340964|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Risk Difference (RD)|14.1||||0.014|TWO_SIDED|95.0|2.9|25.3||This endpoint was the sixth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Mantel Haenszel|Mantel-Haenszel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.||Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.||25.3|2.9|0.014
70924290|NCT03761537|141340965|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Risk Difference (RD)|7.3||||0.228|TWO_SIDED|95.0|-4.6|19.2||This endpoint was the seventh endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Mantel Haenszel|HaenszMantelel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.||Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.||19.2|-4.6|0.228
70924291|NCT03761537|141340966|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Difference|-8.9|||<|0.001|TWO_SIDED|95.0|-13.2|-4.6||This endpoint was the eighth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Repeated measurements model|Unstructured covariance matrix. Adjusted for baseline SCORAD in interaction with each visit, prior CSA use, and baseline disease severity (IGA 3 or 4)||Data collected after permanent discontinuation of IMP, after initiation of rescue treatment, or after subject-onset of the COVID-19 pandemic will not be included in the analysis.||-4.6|-13.2|<0.001
70924292|NCT03761537|141340967|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Difference|-1.6||||0.005|TWO_SIDED|95.0|-2.7|-0.5||This endpoint was the ninth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Repeated measurements model|Unstructured covariance matrix. Adjusted for baseline DLQI in interaction with each visit, prior CSA use, and baseline disease severity (IGA 3 or 4)||Data collected after permanent discontinuation of IMP, after initiation of rescue treatment, or after subject-onset of the COVID-19 pandemic will not be included in the analysis.||-0.5|-2.7|0.005
70924293|NCT03761537|141340968|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Risk Difference (RD)|14.3||||0.014|TWO_SIDED|95.0|2.9|25.6||This endpoint was the tenth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Mantel Haenszel|Mantel-Haenszel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.||Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.||25.6|2.9|0.014
70924294|NCT02736409|141340992|SUPERIORITY||Difference in Proportion|-0.19||||0.131|TWO_SIDED|95.0|-0.452|0.082|||Fisher Exact|||||0.082|-0.452|0.131
70924295|NCT03940963|141341085|NON_INFERIORITY|The visual analog scale (VAS, 0-100 scale) pain score change from baseline value to 12 months was tested for non-inferiority of neurectomy with Axoguard Nerve Cap to standard neurectomy alone using closed testing procedures.||||||0.011||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||0.011
70924296|NCT03940963|141341088|EQUIVALENCE|A predefined equivalence margin was not considered.||||||0.485||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||0.485
71042759|NCT01098110|141594177|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-13.22|STANDARD_ERROR_OF_MEAN|2.09|<|0.0001|TWO_SIDED|95.0|-17.33|-9.12||Statistical significant: p=\<0.05, two sided|ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-9.12|-17.33|<0.0001
71042760|NCT01098110|141594178|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-3.47|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001|TWO_SIDED|95.0|-4.8|-2.13|||ANCOVA|Change from baseline a response variable, baseline score a covariate.|Asenapine 5 mg BID minus Placebo BID|||-2.13|-4.80|<0.0001
71042761|NCT01098110|141594178|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.79|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-5.11|-2.46|||ANCOVA|Change from baseline a response variable, baseline score a covariate.|Asenapine 10 mg BID minus Placebo BID|||-2.46|-5.11|<0.0001
71042762|NCT01098110|141594179|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-2.47|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-3.53|-1.41|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-1.41|-3.53|<0.0001
71042763|NCT01098110|141594179|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.03|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-4.08|-1.97|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-1.97|-4.08|<0.0001
71042764|NCT01098110|141594180|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-5.46|STANDARD_ERROR_OF_MEAN|1.07|<|0.0001|TWO_SIDED|95.0|-7.56|-3.35|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-3.35|-7.56|<0.0001
71042765|NCT01098110|141594180|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-6.53|STANDARD_ERROR_OF_MEAN|1.06|<|0.0001|TWO_SIDED|95.0|-8.62|-4.44||Statistical significant: p=\<0.05, two sided|ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-4.44|-8.62|<0.0001
70924297|NCT03940963|141341089|EQUIVALENCE|A predefined equivalence margin was not considered.||||||0.259||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||0.259
71042766|NCT01098110|141594181|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-3.41|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-4.72|-2.09|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-2.09|-4.72|<0.0001
71042767|NCT01098110|141594181|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.66|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-4.97|-2.35|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-2.35|-4.97|<0.0001
71042768|NCT01098110|141594182|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-2.36|STANDARD_ERROR_OF_MEAN|0.56|<|0.0001|TWO_SIDED|95.0|-3.47|-1.26|||ANCOVA|Change from baseline a response variable, baseline score a covariate.|Asenapine 5 mg BID minus Placebo BID|||-1.26|-3.47|<0.0001
71042769|NCT01098110|141594182|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.94|STANDARD_ERROR_OF_MEAN|0.56|<|0.0001|TWO_SIDED|95.0|-4.03|-1.84|||ANCOVA|Change from baseline a response variable, baseline score a covariate.|Asenapine 10 mg BID minus Placebo BID|||-1.84|-4.03|<0.0001
71042770|NCT01098110|141594183|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-2.72|STANDARD_ERROR_OF_MEAN|0.52|<|0.0001|TWO_SIDED|95.0|-3.73|-1.7|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-1.70|-3.73|<0.0001
71042771|NCT01098110|141594183|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.08|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001|TWO_SIDED|95.0|-4.09|-2.08|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-2.08|-4.09|<0.0001
71042772|NCT01098110|141594184|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-1.62|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-2.41|-0.83|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-0.83|-2.41|<0.0001
71042773|NCT01098110|141594184|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.26|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-3.04|-1.47|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-1.47|-3.04|<0.0001
71042774|NCT01098110|141594185|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-1.41|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-2.04|-0.78|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-0.78|-2.04|<0.0001
71042775|NCT01098110|141594185|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.53|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-2.16|-0.91|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-0.91|-2.16|<0.0001
71042776|NCT01098110|141594186|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.6||||0.0001|TWO_SIDED|95.0|9.2|28.1||Adjusted for region.|Cochran-Mantel-Haenszel||Asenapine 5 mg BID minus Placebo BID|||28.1|9.2|0.0001
71042777|NCT01098110|141594186|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|23.1|||<|0.0001|TWO_SIDED|95.0|13.7|32.6||Adjusted for region.|Cochran-Mantel-Haenszel||Asenapine 10 mg BID minus Placebo BID|||32.6|13.7|<0.0001
71001933|NCT01696396|141511367|SUPERIORITY||Odds Ratio (OR)|1.65||||0.34|TWO_SIDED|90.0|0.69|3.91|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.91|0.69|0.34
71001934|NCT01696396|141511367|SUPERIORITY||Difference in Adjusted Remission Rates|5.0|||||TWO_SIDED|90.0|-3.9|11.7||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||11.7|-3.9|
71001935|NCT01696396|141511367|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|2.82||||0.078|TWO_SIDED|90.0|1.07|7.41|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||7.41|1.07|0.078
71001936|NCT01696396|141511367|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|12.8|||||TWO_SIDED|90.0|-0.6|22.6||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||22.6|-0.6|
71001937|NCT01696396|141511367|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|3.37||||0.083|TWO_SIDED|90.0|1.07|10.66|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||10.66|1.07|0.083
71001938|NCT01696396|141511367|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|16.0|||||TWO_SIDED|90.0|-1.2|28.3||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||28.3|-1.2|
71001939|NCT01696396|141511368|SUPERIORITY||Odds Ratio (OR)|1.52||||0.47|TWO_SIDED|90.0|0.59|3.93|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.93|0.59|0.47
71001940|NCT01696396|141511368|SUPERIORITY||Difference in Adjusted Remission Rates|2.8|||||TWO_SIDED|90.0|-4.7|8.1||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||8.1|-4.7|
71001941|NCT01696396|141511368|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|2.32||||0.21|TWO_SIDED|90.0|0.77|6.98|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||6.98|0.77|0.21
71001942|NCT01696396|141511368|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|6.8|||||TWO_SIDED|90.0|-4.3|14.5||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||14.5|-4.3|
71001943|NCT01696396|141511368|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|2.66||||0.21|TWO_SIDED|90.0|0.75|9.45|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||9.45|0.75|0.21
71001944|NCT01696396|141511368|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|8.4|||||TWO_SIDED|90.0|-6.0|17.9||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||17.9|-6.0|
71001945|NCT01696396|141511369|SUPERIORITY||LS Mean Treatment Difference|-42.09||||0.006|TWO_SIDED|90.0|-67.3|-16.9|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||-16.9|-67.3|0.006
71001946|NCT01696396|141511369|SUPERIORITY|Analysis was not part of the formal testing|LS Mean Treatment Difference|-40.79||||0.095|TWO_SIDED|90.0|-81.5|-0.5|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||-0.5|-81.5|0.095
71042778|NCT01098110|141594187|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-0.52|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.75|-0.28|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-0.28|-0.75|<0.0001
71042779|NCT01098110|141594187|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.82|-0.36|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-0.36|-0.82|<0.0001
71042780|NCT01098110|141594188|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|22.2|||<|0.0001|TWO_SIDED|95.0|12.0|32.4||Adjusted for region.|Cochran-Mantel-Haenszel||Asenapine 5 mg BID minus Placebo BID|||32.4|12.0|<0.0001
71042781|NCT01098110|141594188|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|28.8|||<|0.0001|TWO_SIDED|95.0|18.9|38.8||Adjusted for region.|Cochran-Mantel-Haenszel||Asenapine 10 mg BID minus Placebo BID|||38.8|18.9|<0.0001
71042782|NCT02147587|141594189|SUPERIORITY_OR_OTHER||Ratio of GMFR|1.213|||||TWO_SIDED|80.0|1.033|1.424|||ANCOVA|Repeated-measures ANCOVA model for the log-transformed GMFRs are adjusted for baseline factors. GMFRs and 80% CIs are back-transformed from log scale.|Ratio of GMFRs (Tofacitinib/Placebo) at Week 4|Geometric Mean Fold Rise (GMFR) for Tofacitinib versus Placebo (Week 4)||1.424|1.033|
71042783|NCT02147587|141594190|SUPERIORITY_OR_OTHER||Ratio of GMFR|1.03|||||TWO_SIDED|80.0|0.877|1.209|||ANCOVA|Repeated-measures ANCOVA model for the log-transformed GMFRs are adjusted for baseline factors. GMFRs and 80% CIs are back-transformed from log scale.|Ratio of GMFRs (Tofacitinib/Placebo) at Day 1|GMFR for Tofacitinib versus Placebo (Day 1)||1.209|0.877|
71042784|NCT02147587|141594190|SUPERIORITY_OR_OTHER||Ratio of GMFR|1.093|||||TWO_SIDED|80.0|0.924|1.294|||ANCOVA|Repeated-measures ANCOVA model for the log-transformed GMFRs are adjusted for baseline factors. GMFRs and 80% CIs are back-transformed from log scale.|Ratio of GMFRs (Tofacitinib/Placebo) at Week 12|GMFR for Tofacitinib versus Placebo (Week 12)||1.294|0.924|
71100750|NCT02732145|141709686|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of the Urethral Meatus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Urethral Meatus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
71100751|NCT02732145|141709686|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of Hymenal Remnants among patients from different groups?||||||0.0001|||||||Chi-squared|||"Parameter: The incidence of erythema of Hymenal Remnants in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0001
71100752|NCT02732145|141709686|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of Bartholin's Gland Opening among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Bartholin's Gland Opening in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
71100753|NCT02732145|141709686|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of the Vestibule among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Vestibule in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
71100754|NCT02732145|141709686|EQUIVALENCE|Question: Is there a difference in the incidence of smoothness of the Clitoris among patients from different groups?||||||0.0023|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Clitoris in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0023
71001947|NCT01696396|141511369|SUPERIORITY|Analysis was not part of the formal testing|LS Mean Treatment Difference|-36.84||||0.11|TWO_SIDED|90.0|-74.3|0.7|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||0.7|-74.3|0.11
71001948|NCT01696396|141511370|SUPERIORITY||LS Mean Treatment Difference|-27.47||||0.045|TWO_SIDED|90.0|-50.0|-4.9|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||-4.9|-50.0|0.045
71042785|NCT02147587|141594191|SUPERIORITY_OR_OTHER||Ratio of GMT|1.063|||||TWO_SIDED|80.0|0.821|1.375|||ANCOVA|Repeated-measures ANCOVA model for the log-transformed GMTs are adjusted for baseline factors. GMTs and 80% CIs are back-transformed from log scale.|Ratio of GMTs (Tofacitinib/Placebo) at Day 1|Geometric Mean Titer (GMT) for Tofacitinib versus Placebo (Day 1)||1.375|0.821|
71042786|NCT02147587|141594191|SUPERIORITY_OR_OTHER||Ratio of GMT|1.251|||||TWO_SIDED|80.0|0.967|1.618|||ANCOVA|Repeated-measures ANCOVA model for the log-transformed GMTs are adjusted for baseline factors. GMTs and 80% CIs are back-transformed from log scale.|Ratio of GMTs (Tofacitinib/Placebo) at Week 4|GMT for Tofacitinib versus Placebo (Week 4)||1.618|0.967|
71042787|NCT02147587|141594191|SUPERIORITY_OR_OTHER||Ratio of GMT|1.121|||||TWO_SIDED|80.0|0.862|1.459|||ANCOVA|Repeated-measures ANCOVA model for the log-transformed GMTs are adjusted for baseline factors. GMTs and 80% CIs are back-transformed from log scale.|Ratio of GMTs (Tofacitinib/Placebo) at Week 12|GMT for Tofacitinib versus Placebo (Week 12)||1.459|0.862|
71042788|NCT02147587|141594192|SUPERIORITY_OR_OTHER||Difference in percentages|8.39|||||TWO_SIDED|80.0|-4.05|20.56|||80% CI based on Chan and Zhang method|||Tofacitinib versus Placebo (Day 1)||20.56|-4.05|
71042789|NCT02147587|141594192|SUPERIORITY_OR_OTHER||Difference in percentages|14.01|||||TWO_SIDED|80.0|1.57|26.03|||80% CI based on Chan and Zhang method|||Tofacitinib versus Placebo (Week 4)||26.03|1.57|
71001949|NCT01696396|141511370|SUPERIORITY|Analysis was not part of the formal testing|LS Mean Treatment Difference|-23.59||||0.27|TWO_SIDED|90.0|-58.7|11.5|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||11.5|-58.7|0.27
71001950|NCT01696396|141511370|SUPERIORITY|Analysis was not part of the formal testing|LS Mean Treatment Difference|-16.37||||0.45|TWO_SIDED|90.0|-51.8|19.1|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||19.1|-51.8|0.45
71001951|NCT02712008|141511375|SUPERIORITY|Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.|Least square mean difference|-2.09||||0.1368|TWO_SIDED|95.0||0.67||Threshold for significance at 0.05 level.|ANCOVA|||||0.67|- 4.84|0.1368
71001952|NCT02712008|141511375|SUPERIORITY||Least square mean difference|0.04||||0.9716|TWO_SIDED|95.0||2.18||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.||2.18|- 2.10|0.9716
71001953|NCT02712008|141511376|SUPERIORITY||Least square mean difference|2.15||||0.1665|TWO_SIDED|95.0|-0.9|5.2||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||5.20|-0.90|0.1665
71001954|NCT02712008|141511376|SUPERIORITY||Least square mean difference|1.9||||0.2223|TWO_SIDED|95.0|-1.16|4.95||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||4.95|-1.16|0.2223
71001955|NCT02712008|141511376|SUPERIORITY||Least square mean difference|0.39||||0.7943|TWO_SIDED|95.0|-2.54|3.32||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||3.32|-2.54|0.7943
71001956|NCT02712008|141511376|SUPERIORITY||Least square mean difference|0.66||||0.6655|TWO_SIDED|95.0|-2.35|3.67||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||3.67|-2.35|0.6655
71001957|NCT02712008|141511376|SUPERIORITY||Least square mean difference|2.33||||0.1278|TWO_SIDED|95.0|-0.67|5.33||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||5.33|-0.67|0.1278
71001958|NCT02712008|141511376|SUPERIORITY||Least square mean difference|-1.51||||0.3159|TWO_SIDED|-1.51|-4.47|1.45||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||1.45|-4.47|0.3159
71001959|NCT02712008|141511376|SUPERIORITY||Least square mean difference|-0.27||||0.8537|TWO_SIDED|95.0|-3.18|2.63||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||2.63|-3.18|0.8537
71001960|NCT02712008|141511377|SUPERIORITY||Least square mean difference|-24.43||||0.1105|TWO_SIDED|95.0|-54.46|5.61||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.||5.61|-54.46|0.1105
71001961|NCT02712008|141511377|SUPERIORITY||Least square mean difference|-27.79||||0.0183|TWO_SIDED|95.0||||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.||- 4.74|- 50.83|0.0183
71001962|NCT02712008|141511378|SUPERIORITY||Least square mean difference|-55.91||||0.004|TWO_SIDED|95.0||||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||- 18.01|- 93.81|0.0040
71042790|NCT02147587|141594192|SUPERIORITY_OR_OTHER||Difference in percentages|2.65|||||TWO_SIDED|80.0|-10.66|15.83|||80% CI based on Chan and Zhang method|||Tofacitinib versus Placebo (Week 12)||15.83|-10.66|
71042791|NCT01546519|141594197|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.3|||||TWO_SIDED|90.0|0.95|1.78||||||Cmax Mild HI vs. Normal: Based on pooled variance estimates||1.78|0.95|
71042792|NCT01546519|141594197|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.3|||||TWO_SIDED|90.0|0.92|1.83||||||Cmax Moderate HI vs. Normal: Based on pooled variance estimates||1.83|0.92|
71042793|NCT01546519|141594197|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.55|1.37||||||Cmax Severe HI vs. Normal: Based on pooled variance estimates||1.37|0.55|
71042794|NCT01546519|141594197|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.24|||||TWO_SIDED|90.0|0.9|1.71||||||Css Mild HI vs. Normal: Based on pooled variance estimates||1.71|0.90|
71042795|NCT01546519|141594197|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.27|||||TWO_SIDED|90.0|0.89|1.8||||||Css Moderate HI vs. Normal: Based on pooled variance estimates||1.80|0.89|
71042796|NCT01546519|141594197|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.88|||||TWO_SIDED|90.0|0.55|1.41||||||Css Severe HI vs. Normal: Based on pooled variance estimates||1.41|0.55|
71042797|NCT01546519|141594198|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.24|||||TWO_SIDED|90.0|0.89|1.73||||||AUC0-24hr Mild HI vs. Normal: Based on pooled variance estimates||1.73|0.89|
71042798|NCT01546519|141594198|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.31|||||TWO_SIDED|90.0|0.91|1.89||||||AUC0-24hr Moderate HI vs. Normal: Based on pooled variance estimates||1.89|0.91|
71042799|NCT01546519|141594198|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.86|||||TWO_SIDED|90.0|0.53|1.39||||||AUC0-24hr Severe HI vs. Normal: Based on pooled variance estimates||1.39|0.53|
71042800|NCT02958319|141594206|SUPERIORITY||Median Difference (Final Values)|4.1||||0.82|TWO_SIDED|||||p \< 0.05 was considered statistically significant|GENERAL LINEAL MODEL|GENERAL LINEAL MODEL OF REPEATED MEASURES||||||0.82
70924298|NCT03940963|141341090|EQUIVALENCE|A predefined equivalence margin was not considered.||||||0.14||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||0.140
70924299|NCT03940963|141341091|EQUIVALENCE|A predefined equivalence margin was not considered.||||||0.544||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||0.544
70924300|NCT03940963|141341093|EQUIVALENCE|A predefined equivalence margin was not considered.||||||0.049||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||0.049
71100755|NCT02732145|141709686|EQUIVALENCE|Question: Is there a difference in the incidence of smoothness of the Urethral Sulcus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Urethral Sulcus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
71100756|NCT02732145|141709686|EQUIVALENCE|Question: Is there a difference in the incidence of smoothness of the Urethral Meatus among patients from different groups?||||||0.0235|||||||Chi-squared|||"Parameter: The incidence of smoothness of Urethral Meatus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0235
71100757|NCT02732145|141709686|EQUIVALENCE|Question: Is there a difference in the incidence of ischemia of the Clitoris among patients from different groups?||||||0.0021|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Clitoris in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0021
71100758|NCT02732145|141709686|EQUIVALENCE|Question: Is there a difference in the incidence of ischemia of the Urethral Sulcus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Urethral Sulcus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
71100759|NCT02732145|141709686|EQUIVALENCE|Question: Is there a difference in the incidence of ischemia of the Urethral Meatus among patients from different groups?||||||0.0038|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Urethral Meatus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0038
71100760|NCT02732145|141709686|EQUIVALENCE|Question: Is there a difference in the incidence of ischemia of the Vestibule among patients from different groups?||||||0.0019|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Vestibule in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0019
71100761|NCT02732145|141709686|EQUIVALENCE|Question: Is there a difference in the incidence of punctuation of Hart's Line among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of punctuation of Hart's Line in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
71100762|NCT02732145|141709686|EQUIVALENCE|Question: Is there a difference in the incidence of punctuation of the Vestibule among patients from different groups?||||||0.0198|||||||Chi-squared|||"Parameter: The incidence of punctuation of the Vestibule in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy.. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0198
70924301|NCT01809691|141341100|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.08|TWO_SIDED|95.0|0.72|1.02|||Regression, Cox|||||1.02|0.72|.080
70924302|NCT01809691|141341101|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.51|0.67|||Regression, Cox|||||0.67|0.51|<0.001
70924303|NCT03843151|141341105|OTHER||Ratio|192.67|||||TWO_SIDED|90.0|175.19|211.89|||||"The effect of itraconazole on BI 1358894 is estimated by the ratio of geometric mean (BI 1358894 + itraconazole / BI 1358894).~geometric coefficient of variation (gCV) \[%\] = 14.9."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for 'subject' and 'treatment'. The 'subject' effect was considered as random, whereas the 'treatment' effect was considered as fixed.||211.89|175.19|
71001963|NCT02712008|141511378|SUPERIORITY||Least square mean difference|-40.51||||0.0365|TWO_SIDED|95.0|-78.46|-2.57||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||-2.57|-78.46|0.0365
71001964|NCT02712008|141511378|SUPERIORITY||Least square mean difference|-37.15||||0.0454|TWO_SIDED|95.0|-73.53|-0.77||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||-0.77|-73.53|0.0454
71001965|NCT02712008|141511378|SUPERIORITY||Least square mean difference|1.75||||0.9266|TWO_SIDED|95.0|-35.54|39.03||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||39.03|-35.54|0.9266
71001966|NCT02712008|141511378|SUPERIORITY||Least square mean difference|-15.49||||0.4116|TWO_SIDED|95.0|-52.58|21.59||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||21.59|-52.58|0.4116
71100763|NCT02732145|141709686|EQUIVALENCE|Question: Is there a difference in the incidence of papillae of Hart's Line among patients from different groups?||||||0.0004|||||||Chi-squared|||"Parameter: The incidence of papillae of Hart's Line in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0004
71100764|NCT02732145|141709686|EQUIVALENCE|Question: Is there a difference in the incidence of papillae of the Vestibule among patients from different groups?||||||0.0053|||||||Chi-squared|||"Parameter: The incidence of papillae of the Vestibule in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0053
70924304|NCT03843151|141341106|OTHER||Ratio|120.72|||||TWO_SIDED|90.0|105.69|137.87|||||"The effect of itraconazole on BI 1358894 is estimated by the ratio of geometric mean (BI 1358894 + itraconazole / BI 1358894).~geometric coefficient of variation (gCV) \[%\] = 21.7."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for 'subject' and 'treatment'. The 'subject' effect was considered as random, whereas the 'treatment' effect was considered as fixed.||137.87|105.69|
71001967|NCT02712008|141511378|SUPERIORITY||Least square mean difference|3.36||||0.8574|TWO_SIDED|95.0|-33.42|40.14||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||40.14|-33.42|0.8574
71001968|NCT02712008|141511378|SUPERIORITY||Least square mean difference|-38.9||||0.0351|TWO_SIDED|95.0|-75.06|-2.73||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||-2.73|-75.06|0.0351
71001969|NCT02712008|141511379|SUPERIORITY||difference in percentages|-1.8||||0.7617|TWO_SIDED|95.0|-13.5|9.8||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using analysis of Cochran-Mantel-Haenszel model.||9.8|-13.5|0.7617
71001970|NCT02712008|141511379|SUPERIORITY||difference in percentages|6.1||||0.2268|TWO_SIDED|95.0||16.3||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using analysis of Cochran-Mantel-Haenszel model.||16.3|- 4.1|0.2268
71001971|NCT02712008|141511380|SUPERIORITY||difference in percentages|-1.3||||0.8896|TWO_SIDED|95.0|-20.4|17.7||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||17.7|-20.4|0.8896
71001972|NCT02712008|141511380|SUPERIORITY||difference in percentages|6.4||||0.5021|TWO_SIDED|95.0|-12.6|25.5||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||25.5|-12.6|0.5021
71001973|NCT02712008|141511380|SUPERIORITY||difference in percentages|6.0||||0.5273|TWO_SIDED|95.0|-12.8|24.7||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||24.7|-12.8|0.5273
71001974|NCT02712008|141511380|SUPERIORITY||difference in percentages|-1.5||||0.8683|TWO_SIDED|95.0|-19.7|16.6||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||16.6|-19.7|0.8683
71001975|NCT02712008|141511380|SUPERIORITY||difference in percentages|8.8||||0.3546|TWO_SIDED|95.0|-9.8|27.4||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||27.4|-9.8|0.3546
71001976|NCT02712008|141511380|SUPERIORITY||difference in percentages|0.2||||0.9801|TWO_SIDED|95.0|-19.0|19.5||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||19.5|-19.0|0.9801
71001977|NCT02712008|141511380|SUPERIORITY||difference in percentages|8.8||||0.3528|TWO_SIDED|95.0|-9.9|27.4||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||27.4|-9.9|0.3528
71001978|NCT03950440|141511381|OTHER|Propensity scores were obtained from three separate multivariable logistic regression models contrasting each group versus the two other groups. The result from this multivariable model quantifies the degree of separation between both groups.|Risk Ratio (RR)|0.26|||<|0.0001|TWO_SIDED|95.0|0.16|0.44||The double robust approach refers to the weighted analysis with all variables involved in the construction of the propensity-based weights added as confounders in the model.|Poisson regression||TAVI-group compared to the SAVR-group|Frailty scores (Tilburg and essential) and Euroscore were specified in the protocol. Age was added during the meeting before start of the data-analysis|The double robust approach refers to the weighted analysis with all variables involved in the construction of the propensity-based weights added as confounders in the model.|0.44|0.16|<0.0001
71001979|NCT00524043|141511418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|4.2||0.504||95.0|-5.47|11.09||Based on ANCOVA model with treatment (Placebo, Paliperidone ER 1.5 mg, and Paliperidone ER 6 mg) and country as factors, and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA|||Sample size estimation was based on the assumption that the difference between the paliperidone ER 1.5 mg dose group and the placebo group in the mean change in PANSS total score from baseline to end point was 11 points with a within-group standard deviation of 20 points. It was calculated that 65 patients were needed per treatment group to detect a statistically significant treatment difference between the paliperidone ER 1.5 mg dose group and the placebo group with a power of 87.5%.||11.09|-5.47|0.504
71100765|NCT02732145|141709686|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of Hart's Line in patients with vulvar dermatosis?||||||0.001|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of Hart's Line in patients with vulvar dermatosis.||||0.0010
71001980|NCT00524043|141511418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|4.15||0.431||95.0|-11.46|4.9||Based on ANCOVA model with treatment (Placebo, Paliperidone ER 1.5 mg, and Paliperidone ER 6 mg) and country as factors, and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA|Paliperidone ER 6 mg was used for assay sensitivity||||4.90|-11.46|0.431
71042801|NCT01028911|141594252|SUPERIORITY_OR_OTHER||Adjusted Geometric Means Ratio|128.4|||||TWO_SIDED|90.0|75.9|217.21||||||Day 30: Natural log transformed AUCtau of donepezil was analyzed using a mixed effect model with sequence, day and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% confidence intervals for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios. Values were back-transformed from the log scale.||217.21|75.90|
71001981|NCT00524043|141511419|SUPERIORITY_OR_OTHER|||||||0.626||95.0||||Based on ANCOVA model on ranks with treatment (Placebo, Paliperidone ER 1.5 mg, and Paliperidone ER 6 mg) and country as factors, and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA|||||||0.626
71001982|NCT00524043|141511420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|2.69||0.87||95.0|-4.86|5.74||Based on ANCOVA model with treatment (placebo, paliperidone ER 1.5 mg, and paliperidone ER 6 mg) and country as factors, and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA|||||5.74|-4.86|0.870
71001983|NCT00524043|141511421|SUPERIORITY_OR_OTHER|||||||0.126||95.0||||Based on ANCOVA model with treatment (placebo, paliperidone ER 1.5 mg, and paliperidone ER 6 mg) and country as factors and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA|||||||0.126
71001984|NCT00524043|141511422|SUPERIORITY_OR_OTHER|||||||0.691||95.0||||Based on ANCOVA model with treatment (placebo, paliperidone ER 1.5 mg, and paliperidone ER 6 mg) and country as factors and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA|||||||0.691
71001985|NCT04211961|141511449|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
71001986|NCT04211961|141511450|SUPERIORITY||||||>|0.9|||||||Fisher Exact|||||||>0.9
71001987|NCT04211961|141511451|SUPERIORITY|||||||0.3|||||||Fisher Exact|||||||0.3
71001988|NCT04211961|141511452|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.5
71001989|NCT04211961|141511454|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.6
71001990|NCT04211961|141511455|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
71001991|NCT04211961|141511456|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
71001992|NCT04211961|141511458|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||||||0.024
71001993|NCT04211961|141511459|SUPERIORITY|||||||0.9|||||||Fisher Exact|||||||0.9
71001994|NCT04211961|141511460|SUPERIORITY||||||>|0.9|||||||Fisher Exact|||||||>0.9
71001995|NCT04211961|141511461|SUPERIORITY||||||>|0.9|||||||Fisher Exact|||||||>0.9
71001996|NCT04211961|141511462|SUPERIORITY||||||>|0.9|||||||Fisher Exact|||||||>0.9
71001997|NCT01156363|141511477|SUPERIORITY_OR_OTHER|||||||0.9825|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 1: analysis was performed using paired t-test.||||0.9825
71001998|NCT01156363|141511477|SUPERIORITY_OR_OTHER|||||||0.5737|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 1: analysis was performed using paired t-test.||||0.5737
71001999|NCT01156363|141511477|SUPERIORITY_OR_OTHER|||||||0.5703|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 1: analysis was performed using paired t-test.||||0.5703
71002000|NCT01156363|141511477|SUPERIORITY_OR_OTHER|||||||0.5684|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 1: analysis was performed using paired t-test.||||0.5684
71002001|NCT01156363|141511477|SUPERIORITY_OR_OTHER|||||||0.8235|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 2: analysis was performed using paired t-test.||||0.8235
71002002|NCT01156363|141511477|SUPERIORITY_OR_OTHER|||||||0.2384|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 2: analysis was performed using paired t-test.||||0.2384
71002003|NCT01156363|141511477|SUPERIORITY_OR_OTHER|||||||0.1634|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 2: analysis was performed using paired t-test.||||0.1634
71002004|NCT01156363|141511477|SUPERIORITY_OR_OTHER|||||||0.7816|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 2: analysis was performed using paired t-test.||||0.7816
71002005|NCT01156363|141511477|SUPERIORITY_OR_OTHER|||||||0.3917|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 3: analysis was performed using paired t-test.||||0.3917
71002006|NCT01156363|141511477|SUPERIORITY_OR_OTHER|||||||0.1749|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 3: analysis was performed using paired t-test.||||0.1749
71002007|NCT01156363|141511477|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 3: analysis was performed using paired t-test.||||<0.001
71002008|NCT01156363|141511477|SUPERIORITY_OR_OTHER|||||||0.0905|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 3: analysis was performed using paired t-test.||||0.0905
71002009|NCT01156363|141511477|SUPERIORITY_OR_OTHER|||||||0.3766|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 4: analysis was performed using paired t-test.||||0.3766
71002010|NCT01156363|141511477|SUPERIORITY_OR_OTHER|||||||0.0253|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 4: analysis was performed using paired t-test.||||0.0253
71002011|NCT01156363|141511477|SUPERIORITY_OR_OTHER|||||||0.0209|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 4: analysis was performed using paired t-test.||||0.0209
71002012|NCT01156363|141511477|SUPERIORITY_OR_OTHER|||||||0.8206|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 4: analysis was performed using paired t-test.||||0.8206
71002013|NCT01156363|141511477|SUPERIORITY_OR_OTHER|||||||0.0907|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 5: analysis was performed using paired t-test.||||0.0907
71002014|NCT01156363|141511477|SUPERIORITY_OR_OTHER|||||||0.0177|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 5: analysis was performed using paired t-test.||||0.0177
71002015|NCT01156363|141511477|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 5: analysis was performed using paired t-test.||||0.0050
71002016|NCT01156363|141511477|SUPERIORITY_OR_OTHER|||||||0.3724|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 5: analysis was performed using paired t-test.||||0.3724
71002017|NCT01156363|141511477|SUPERIORITY_OR_OTHER|||||||0.2796|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 6: analysis was performed using paired t-test.||||0.2796
71002018|NCT01156363|141511477|SUPERIORITY_OR_OTHER|||||||0.0066|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 6: analysis was performed using paired t-test.||||0.0066
71002019|NCT01156363|141511477|SUPERIORITY_OR_OTHER|||||||0.0081|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 6: analysis was performed using paired t-test.||||0.0081
71002020|NCT01156363|141511477|SUPERIORITY_OR_OTHER|||||||0.7853|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 6: analysis was performed using paired t-test.||||0.7853
71002021|NCT01156363|141511477|SUPERIORITY_OR_OTHER|||||||0.0039|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 7: analysis was performed using paired t-test.||||0.0039
71002022|NCT01156363|141511477|SUPERIORITY_OR_OTHER|||||||0.3057|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 7: analysis was performed using paired t-test.||||0.3057
71002023|NCT01156363|141511477|SUPERIORITY_OR_OTHER|||||||0.3374|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 7: analysis was performed using paired t-test.||||0.3374
71042802|NCT01028911|141594253|SUPERIORITY_OR_OTHER||Adjusted Geometric Means Ratio|119.82|||||TWO_SIDED|90.0|75.9|189.16||||||Day 30: Natural log transformed AUCtau of donepezil was analyzed using a mixed effect model with sequence, day and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% confidence intervals for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios. Values were back-transformed from the log scale.||189.16|75.90|
71042803|NCT01077817|141594264|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.7|1.5|||Logistic Regression Model|The case-cohort hazard ratio estimate for drug exposure was based on analysis of all cases of esophageal cancer and their comparison sample.||A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to alendronate treatment and incidence of esophageal cancer.||1.5|0.7|
71002024|NCT01156363|141511477|SUPERIORITY_OR_OTHER|||||||0.141|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 7: analysis was performed using paired t-test.||||0.1410
71002025|NCT01156363|141511477|SUPERIORITY_OR_OTHER|||||||0.0017|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 8: analysis was performed using paired t-test.||||0.0017
71002026|NCT01156363|141511477|SUPERIORITY_OR_OTHER|||||||0.0677|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 8: analysis was performed using paired t-test.||||0.0677
71002027|NCT01156363|141511477|SUPERIORITY_OR_OTHER|||||||0.1608|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 8: analysis was performed using paired t-test.||||0.1608
71002028|NCT01156363|141511477|SUPERIORITY_OR_OTHER|||||||0.0196|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 8: analysis was performed using paired t-test.||||0.0196
71002029|NCT02773368|141511496|NON_INFERIORITY|Non-inferiority of IDegLira was considered confirmed if the upper limit of the two-sided 95% confidence interval (CI) for mean treatment difference (IDegLira minus IGlar) was strictly below 0.3%.|Treatment Contrast|-0.34|||||TWO_SIDED|95.0|-0.48|-0.2|||ANCOVA||IDegLira minus IGlar|Analysis was based on ANCOVA model with treatment, pre-trial OAD, region as factors and baseline HbA1c as covariate. Data obtained after premature treatment discontinuation are included in the analysis. Missing data was imputed using unconditional reference based multiple imputation including data obtained after premature treatment discontinuation. The non-inferiority margin of 0.3 % was added to the end-of-treatment value for prematurely discontinued and withdrawn from trial IDegLira subjects.||-0.20|-0.48|
71042804|NCT01077817|141594264|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.9|2.0|||Logistic Regression Model|The case-cohort hazard ratio estimate for drug exposure was based on analysis of all cases of esophageal cancer and their comparison sample.||A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to etidronate treatment and incidence of esophageal cancer.||2.0|0.9|
71042805|NCT01077817|141594264|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|4.9|||||TWO_SIDED|95.0|1.4|16.7|||Logistic Regression Model|The case-cohort hazard ratio estimate for drug exposure was based on analysis of all cases of esophageal cancer and their comparison sample.||A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to ibandronate treatment and incidence of esophageal cancer.||16.7|1.4|
71042806|NCT01077817|141594264|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.6|||||TWO_SIDED|95.0|1.0|2.5|||Logistic Regression Model|The case-cohort hazard ratio estimate for drug exposure was based on analysis of all cases of esophageal cancer and their comparison sample.||A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to risedronate treatment and incidence of esophageal cancer.||2.5|1.0|
71100766|NCT02732145|141709686|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Urethral Sulcus in patients with vulvar dermatosis?||||||0.001|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Urethral Sulcus in patients with vulvar dermatosis.||||0.0010
71100767|NCT02732145|141709686|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Vestibule in patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Vestibule in patients with vulvar dermatosis.||||0.0000
71100768|NCT02732145|141709686|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with vulvar dermatosis?||||||0.0208|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with vulvar dermatosis.||||0.0208
71042807|NCT01077817|141594264|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.2|2.2|||Logistic Regression Model|The case-cohort hazard ratio estimate for drug exposure was based on analysis of all cases of esophageal cancer and their comparison sample.||A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to raloxifene treatment and incidence of esophageal cancer.||2.2|0.2|
71100769|NCT02732145|141709686|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis?||||||0.0007|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis.||||0.0007
71100770|NCT02732145|141709686|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with vulvar dermatosis?||||||0.0208|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with vulvar dermatosis.||||0.0208
71100771|NCT02732145|141709686|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis?||||||0.0007|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis.||||0.0007
71100772|NCT02732145|141709686|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with vulvar dermatosis?||||||0.004|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with vulvar dermatosis.||||0.0040
71100773|NCT02732145|141709686|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with vulvar dermatosis?||||||0.0012|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with vulvar dermatosis.||||0.0012
71100774|NCT02732145|141709686|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Bartholin's Gland Opening versus non-specific lesions of the Vestibule in patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Bartholin's Gland Opening versus non-specific lesions of the Vestibule in patients with vulvar dermatosis.||||0.0000
71100775|NCT02732145|141709686|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of the Urethral Meatus in patients with vulvodynia?||||||0.0048|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of the Urethral Meatus in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0048
71100776|NCT02732145|141709686|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with vulvodynia?||||||0.0007|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0007
71042808|NCT01077817|141594265|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.7|1.3|||Proportional Hazards Regression Model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of alendronate~compared to non-initiators of alendronate. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used."||1.3|0.7|
71002030|NCT02773368|141511496|SUPERIORITY|Superiority of IDegLira was considered confirmed if the test procedure was not stopped (i.e. non-inferiority of IDegLira was confirmed for change from baseline in HbA1c; and superiority of IDegLira was confirmed for weight change and the number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes) and if the upper limit of the two-sided 95% CI for the mean treatment difference (IDegLira minus IGlar) in change from baseline in HbA1c was strictly below 0%.|Treatment Contrast|-0.36|||||TWO_SIDED|95.0|-0.5|-0.21|||ANCOVA||IDegLira minus IGlar|This endpoint was analysed using an ANCOVA model with treatment, pre-trial OAD and region as factors and corresponding baseline value as covariate. Data obtained after premature treatment discontinuation were included in the analysis. Missing data were imputed using unconditional reference based multiple imputation including data obtained after premature treatment discontinuation.||-0.21|-0.50|
71042809|NCT01077817|141594265|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.8|2.0|||Proportional Hazards Regression Model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of etidronate~compared to non-initiators of etidronate. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used."||2.0|0.8|
71042810|NCT01077817|141594265|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.5|3.4|||Proportional Hazards Regression Model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of ibandronate~compared to non-initiators of ibandronate. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used."||3.4|0.5|
71100777|NCT02732145|141709686|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of the Urethral Meatus in patients with vulvodynia?||||||0.0048|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of the Urethral Meatus in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0048
71100778|NCT02732145|141709686|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with vulvodynia?||||||0.0007|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0007
71100779|NCT02732145|141709686|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with vulvodynia?||||||0.0131|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0131
71100780|NCT02732145|141709686|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of Bartholin's Gland Opening in patients with vulvodynia?||||||0.0423|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of Bartholin's Gland Opening in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0423
71100781|NCT02732145|141709686|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with vulvodynia?||||||0.0021|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0021
71100782|NCT02732145|141709686|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of Hart's Line in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of Hart's Line in patients with impaired vulvar skin.||||0.0000
71100783|NCT02732145|141709686|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Urethral Sulcus in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Urethral Sulcus in patients with impaired vulvar skin.||||0.0000
71100784|NCT02732145|141709686|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Vestibule in patients with impaired vulvar skin?||||||0.0091|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Vestibule in patients with impaired vulvar skin.||||0.0091
71100785|NCT02732145|141709686|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of the Urethral Meatus in patients with impaired vulvar skin?||||||0.0002|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of the Urethral Meatus in patients with impaired vulvar skin.||||0.0002
70924305|NCT03843151|141341107|OTHER||Ratio|120.72|||||TWO_SIDED|90.0|105.69|137.87|||||"The effect of itraconazole on BI 1358894 is estimated by the ratio of geometric mean (BI 1358894 + itraconazole / BI 1358894).~geometric coefficient of variation (gCV) \[%\] = 13.3."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for 'subject' and 'treatment'. The 'subject' effect was considered as random, whereas the 'treatment' effect was considered as fixed.||137.87|105.69|
71042811|NCT01077817|141594265|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.9|2.0|||Proportional Hazards Regression Model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of risendronate~compared to non-initiators of risendronate. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used."||2.0|0.9|
71042812|NCT01077817|141594265|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.3|2.3|||Proportional Hazards Regression Model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of raloxifene~compared to non-initiators of raloxifene. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used."||2.3|0.3|
71042813|NCT01077817|141594265|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.7|1.5|||Proportional Hazards Regression Model|||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of~alendronate compared to non-initiators of alendronate. For calculation of 721+ day hazard ratios, only esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used."||1.5|0.7|
71042814|NCT01077817|141594265|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.7|1.9|||Proportional Hazards Regression Model|||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of~etidronate compared to non-initiators of etidronate. For calculation of 721+ day hazard ratios, only~esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used."||1.9|0.7|
71042815|NCT01077817|141594265|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|3.0|||||TWO_SIDED|95.0|0.8|11.1|||Proportional Hazards Regression Model|||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of~ibandronate compared to non-initiators of ibandronate. For calculation of 721+ day hazard ratios,~only esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used."||11.1|0.8|
71100786|NCT02732145|141709686|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with impaired vulvar skin.||||0.0000
71100787|NCT02732145|141709686|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Bartholin's Gland Opening in patients with impaired vulvar skin?||||||0.0013|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Bartholin's Gland Opening in patients with impaired vulvar skin.||||0.0013
71100788|NCT02732145|141709686|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of the Urethral Meatus in patients with impaired vulvar skin?||||||0.0001|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of the Urethral Meatus in patients with impaired vulvar skin.||||0.0001
71100789|NCT02732145|141709686|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with impaired vulvar skin.||||0.0000
70924306|NCT01787383|141341108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.13
70924307|NCT01787383|141341109|SUPERIORITY_OR_OTHER_LEGACY|||||||0.34|TWO_SIDED||||||Regression, Logistic|||||||0.34
71042816|NCT01077817|141594265|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.8|||||TWO_SIDED|95.0|1.1|3.0|||Proportional Hazards Regression Model|||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of~risedronate compared to non-initiators of risedronate. For calculation of 721+ day hazard ratios,~only esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used."||3.0|1.1|
71042817|NCT01077817|141594265|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.1|2.7|||Proportional Hazards Regression Model|||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of~raloxifene compared to non-initiators of raloxifene. For calculation of 721+ day hazard ratios, only~esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used."||2.7|0.1|
71100790|NCT02732145|141709686|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Bartholin's Gland Opening in patients with impaired vulvar skin?||||||0.0008|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Bartholin's Gland Opening in patients with impaired vulvar skin.||||0.0008
71100791|NCT02732145|141709686|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with impaired vulvar skin?||||||0.0251|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with impaired vulvar skin.||||0.0251
70924308|NCT01787383|141341110|SUPERIORITY_OR_OTHER_LEGACY|||||||0.088|TWO_SIDED||||||Regression, Logistic|||||||0.088
70924309|NCT01787383|141341111|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.20
70924310|NCT01787383|141341112|SUPERIORITY_OR_OTHER_LEGACY|||||||0.38|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.38
71002031|NCT02773368|141511497|SUPERIORITY|Superiority of IDegLira was considered confirmed if the test procedure was not stopped (i.e. non-inferiority of IDegLira was confirmed for change from baseline in HbA1c) and if the upper limit of the two-sided 95% CI for the mean treatment difference (IDegLira minus IGlar) in change from baseline in body weight was strictly below 0 kg.|Treatment Contrast|-1.92|||||TWO_SIDED|95.0|-2.64|-1.19|||ANCOVA||IDegLira minus IGlar|This endpoint was analysed using an ANCOVA model with treatment, pre-trial OAD and region as factors and corresponding baseline weight as covariate. Data obtained after premature treatment discontinuation were included in the analysis. Missing data were imputed using unconditional reference based multiple imputation including data obtained after premature treatment discontinuation.||-1.19|-2.64|
71002032|NCT02773368|141511498|SUPERIORITY|Superiority of IDegLira was considered confirmed if the test procedure was not stopped (i.e. non-inferiority of IDegLira was confirmed for change from baseline in HbA1c and superiority of IDegLira was confirmed for change from baseline in body weight) and if the upper limit of the two-sided 95% CI for the rate ratio (IDegLira over IGlar) of rate of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes was strictly below 1.|Treatment Ratio|0.42|||||TWO_SIDED|95.0|0.23|0.75|||Negative binomial regression model||IDegLira over IGlar|This endpoint was analysed using a negative binomial regression model with a log link and the logarithm of the exposure time as offset. The model included treatment and pre-trial OAD as fixed factors. Missing data were imputed using multiple imputations (conditioning on expected event rate before premature treatment discontinuation or withdrawal from trial as if treated with IGlar).||0.75|0.23|
71042818|NCT01077817|141594265|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.5|1.6|||Proportional Hazards Regression Model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of alendronate~compared to non-initiators of alendronate. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug (data not shown) were used."||1.6|0.5|
71042819|NCT01077817|141594265|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.6|2.0||Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.|Proportional hazards regression model|||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of etidronate~compared to non-initiators of etidronate. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug (data not shown) were used."||2.0|0.6|
71042820|NCT01077817|141594265|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.4|2.5|||Proportional hazards regression model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of risedronate~compared to non-initiators of risedronate. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug (data not shown) were used."||2.5|0.4|
71042821|NCT01077817|141594265|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.2|3.9|||Proportional hazards regression model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of raloxifene~compared to non-initiators of raloxifene. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug (data not shown) were used."||3.9|0.2|
71042822|NCT00530348|141594266|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.2173|TWO_SIDED|95.0|0.4|1.23||Hochberg method was used to adjust for the two co-primary outcomes.|Cox Proportional Hazards Regression|||Cox proportional hazards (PH) regression model with robust variance estimation using treatment group and geographic region as covariates was used.||1.23|0.40|0.2173
71042823|NCT00530348|141594267|SUPERIORITY_OR_OTHER||Rate ratio|0.45|||<|0.0001|TWO_SIDED|95.0|0.32|0.63||Hochberg method was used to adjust for the two co-primary outcomes.|Proportional means regression|||Proportional means regression model with robust variance estimation and covariate adjustment for geographic region was used.||0.63|0.32|<0.0001
71042824|NCT00530348|141594268|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.33|0.61|||Cox Proportional Hazards Regression|||Cox PH regression model with robust variance estimation, covariate adjustment for geographic region, was used. Secondary endpoints were analyzed sequentially as: Proportion of participants relapse free at Year 2, Change from baseline in EDSS, Percent change from Baseline in magnetic resonance imaging-T2 hyperintense lesion volume at Year 2, Acquisition of disability measured by multiple sclerosis functional composite. Each endpoint could only be formally tested if prior endpoint was significant.||0.61|0.33|<0.0001
71042825|NCT00530348|141594269|SUPERIORITY_OR_OTHER|||||||0.4188|||||||Wei-Lachin|||The analysis was performed using Wei-Lachin method for non-parametric analysis of repeated measures. Secondary endpoints were analyzed sequentially as: Proportion of participants relapse free at Year 2, Change from baseline in EDSS, Percent change from Baseline in magnetic resonance imaging-T2 hyperintense lesion volume at Year 2, Acquisition of disability measured by multiple sclerosis functional composite. Each endpoint could only be formally tested if prior endpoint was significant.||||0.4188
71042826|NCT00530348|141594270|SUPERIORITY_OR_OTHER|||||||0.0115|||||||Wei-Lachin|||Change at Year 2: analysis was performed using Wei-Lachin method for non-parametric analysis of repeated measures. Secondary endpoints were analyzed sequentially as: Proportion of participants relapse free at Year 2, Change from baseline in EDSS, Percent change from Baseline in magnetic resonance imaging-T2 hyperintense lesion volume at Year 2, Acquisition of disability measured by MSFC. Each endpoint could only be formally tested if prior endpoint was significant.||||0.0115
70924311|NCT01787383|141341113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.033|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.033
70924312|NCT01787383|141341114|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.37
71002033|NCT02773368|141511499|SUPERIORITY|Superiority of IDegLira was considered confirmed if the test procedure was not stopped (i.e. non-inferiority of IDegLira was confirmed for change from baseline in HbA1c; and superiority of IDegLira was confirmed for weight change, number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes and change in HbA1c) and if the upper limit of the two-sided 95% CI for the mean treatment difference (IDegLira minus IGlar) in insulin dose after 26 weeks was strictly below 0 U.|Treatment Contrast|-15.37|||||TWO_SIDED|95.0|-19.6|-11.13|||ANCOVA||IDegLira minus IGlar|The endpoint was analysed using an ANCOVA model with treatment, pre-trial OAD and region as factors and corresponding baseline HbA1c as covariate. Missing data were imputed using unconditional reference based multiple imputation including data obtained after premature treatment discontinuation.||-11.13|-19.60|
71002034|NCT01665872|141511529|EQUIVALENCE|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.172|||||||t-test, 2 sided|||||||0.172
71002035|NCT01665872|141511530|EQUIVALENCE|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.5337|||||||Wilcoxon (Mann-Whitney)|||Are CES-D scores at 12 months different between groups?||||0.5337
71002036|NCT01665872|141511531|EQUIVALENCE|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.092||||||This test looks at a difference in Parental Distress at the 12 month follow-up between groups.|Wilcoxon (Mann-Whitney)|||||||0.0920
71002037|NCT01665872|141511531|EQUIVALENCE|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.3352||||||This test looks at a difference in Parent-Child Dysfunctional Interaction at the 12 month follow-up between groups.|Wilcoxon (Mann-Whitney)|||||||0.3352
71002038|NCT01665872|141511531|EQUIVALENCE|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.0404||||||This test looks at a difference in Difficult Child at the 12 month follow-up between groups.|Wilcoxon (Mann-Whitney)|||||||0.0404
71002039|NCT01665872|141511531|EQUIVALENCE|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.0915||||||This test looks at a difference in PSI total score (percentile) at the 12 month follow-up between groups.|Wilcoxon (Mann-Whitney)|||||||0.0915
71002040|NCT01665872|141511532|EQUIVALENCE|Chi-square was used with a p-value of 0.05 to determine if the difference was statistically greater than 0.||||||0.2914|||||||Chi-squared|||||||0.2914
71002041|NCT01929018|141511537|SUPERIORITY|||||||0.87|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.87
70924313|NCT01787383|141341115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.66
71002042|NCT01929018|141511537|SUPERIORITY|||||||0.38|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.38
71002043|NCT01929018|141511538|SUPERIORITY|||||||0.75|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.75
71002044|NCT01929018|141511538|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.11
71002045|NCT01929018|141511539|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.11
71002046|NCT01929018|141511539|SUPERIORITY|||||||0.23|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.23
71042827|NCT00530348|141594271|SUPERIORITY_OR_OTHER|||||||0.308|TWO_SIDED||||||Ranked ANCOVA|||Ranked ANCOVA models with covariate adjustment for geographic region and baseline T2 lesion volume was used. Secondary endpoints were analyzed sequentially as: Proportion of participants relapse free at Year 2, Change from baseline in EDSS, Percent change from Baseline in magnetic resonance imaging-T2 hyperintense lesion volume at Year 2, Acquisition of disability measured by multiple sclerosis functional composite. Each endpoint could only be formally tested if prior endpoint was significant.||||0.3080
71042828|NCT04364763|141594272|SUPERIORITY|||||||0.0352||||||p-value is for Day 7|Mixed Models Analysis|||||||0.0352
71042829|NCT04364763|141594272|SUPERIORITY|||||||0.235||||||p-value is for Day 28|Mixed Models Analysis|||Comparison made for Day 7 and Day 28||||0.2350
71042830|NCT01386125|141594273|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.14||||0.0007|TWO_SIDED|95.0|-0.22|-0.06|||ANCOVA|||||-0.06|-0.22|0.0007
71002047|NCT01929018|141511540|SUPERIORITY|||||||0.27|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.27
71002048|NCT01929018|141511540|SUPERIORITY|||||||0.58|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.58
71002049|NCT01929018|141511541|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.83
71002050|NCT01929018|141511541|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.13
71002051|NCT01929018|141511542|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.03
71002052|NCT01929018|141511542|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.02
71002053|NCT01929018|141511543|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.03
71042831|NCT01386125|141594274|SUPERIORITY_OR_OTHER_LEGACY||Difference is LS Means|-0.3|||<|0.0001|TWO_SIDED|95.0|-0.45|-0.15|||Constrained longitudinal data analysis|||||-0.15|-0.45|<0.0001
71042832|NCT01201486|141594292|SUPERIORITY_OR_OTHER||Percentage Sensitivity|23.0|||||TWO_SIDED||||||Percentage Sensitivity|||||||
71042833|NCT03604549|141594309|SUPERIORITY||Risk Ratio (RR)|0.44||||0.1|TWO_SIDED|95.0|0.16|1.25|||Chi-squared||Lipiodol UF is the numerator and Saline is the denominator for RR|||1.25|0.16|0.10
70924314|NCT04533347|141341116|SUPERIORITY|||||||0.1879|TWO_SIDED|95.0|||||Fisher Exact|||Assuming an 85% clinical recovery rate in the TQ group and a 70% clinical recovery rate in the placebo group, sample sizes of 125 per treatment group were expected to achieve 80% power with a two-sided alpha of 0.05.||||0.1879
70924315|NCT04831216|141341145|OTHER|||||||0.0107||||||The p-value reflects results of analysis of change in HbA1c from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.0107
70924316|NCT04831216|141341146|OTHER|||||||0.7927||||||The p-value reflects results of analysis of change in skin carotenoid levels from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.7927
71002054|NCT01929018|141511543|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.06
71042834|NCT03604549|141594310|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.96|TWO_SIDED|95.0|-1.59|1.68|||t-test, 2 sided||Difference reported as Lipiodol UF - Saline|||1.68|-1.59|0.96
71002055|NCT01929018|141511544|SUPERIORITY|||||||0.62|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.62
71002056|NCT01929018|141511544|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.40
71002057|NCT01929018|141511545|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.96
71002058|NCT01929018|141511545|SUPERIORITY|||||||0.35|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.35
71042835|NCT00436917|141594335|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0|||||Kruskal-Wallis|||A sample of 60 participants was estimated to provide percentage statistics accuracy to within 13% with 95% confidence.||||0.01
71042836|NCT02438540|141594347|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
71042837|NCT02438540|141594348|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
70924317|NCT04831216|141341147|OTHER|||||||0.4651||||||The p-value reflects results of analysis of change in HEI score from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.4651
71002059|NCT01366534|141511547|OTHER||Vaccine Efficacy Maentel-Haenzel Method|-17.6||||0.7675|TWO_SIDED|95.0|-107.4|33.3|||2-sided Fisher Exact test||Pre-defined futility criteria for efficacy: point estimate of increase of VE in Ad35.CS.01 Group over GSK257049 Group less than 0%|Comparison of the efficacy (occurrence of P. falciparum parasitemia, assessed by blood slide) of an immunization regimen comprising of one dose of Ad35.CS.01 vaccine followed one month later by 2 doses of GSK257049 vaccine administered at one month intervals, with that of 3 doses of GSK257049 vaccine administered at one month intervals, in healthy malaria-naïve volunteers aged 18-50 years in the sporozoite challenge model.||33.3|-107.4|0.7675
70924318|NCT04831216|141341148|OTHER|||||||0.2439||||||The p-value reflects results of analysis of change in BMI from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.2439
71002060|NCT01366534|141511547|OTHER||Vaccine Efficacy: Maentel-Haenzel Method|44.0||||0.0066|TWO_SIDED|95.0|20.7|60.4|||2-sided Fisher Exact test|||Comparison of the efficacy (occurrence of P. falciparum parasitemia, assessed by blood slide) of an immunization regimen comprising of one dose of Ad35.CS.01 vaccine followed one month later by 2 doses of GSK257049 vaccine administered at 1 month intervals, with that of 3 doses of GSK257049 vaccine administered at one month intervals, in healthy malaria-naïve volunteers aged 18-50 years in the sporozoite challenge model.||60.4|20.7|0.0066
71042838|NCT02438540|141594349|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
71042839|NCT02438540|141594350|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
71042840|NCT02438540|141594351|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|90.0|||||ANOVA|||||||0.04
71042841|NCT02438540|141594352|NON_INFERIORITY_OR_EQUIVALENCE|multiple comparatives||||||0.082|TWO_SIDED|90.0||||CRP is known to be an independent parameter|ANOVA|||||||0.082
71042842|NCT02438540|141594352|NON_INFERIORITY_OR_EQUIVALENCE|from 0.60±0.03 mg/dl before treatment to 0.57±0.03 mg/dl after treatment, P=0.082||||||0.082|TWO_SIDED|90.0||||CRP is known to be an independent parameter|ANOVA|||||||0.082
71042843|NCT02438540|141594352|NON_INFERIORITY_OR_EQUIVALENCE|from 0.59±0.03 mg/dl before treatment to 0.57±0.03 mg/dl after treatment, P=0.082||||||0.082|TWO_SIDED|90.0||||CRP is known to be an independent parameter|ANOVA|||||||0.082
71042844|NCT02438540|141594353|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
71042845|NCT02438540|141594354|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
71042846|NCT02438540|141594355|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
71042847|NCT02438540|141594356|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
71042848|NCT02438540|141594357|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
71042849|NCT02438540|141594358|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
71042850|NCT02438540|141594359|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
71042851|NCT02438540|141594360|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
71042852|NCT02438540|141594361|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
71042853|NCT02438540|141594362|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
71042854|NCT02438540|141594363|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
71042855|NCT02438540|141594364|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
71042856|NCT05766787|141594376|NON_INFERIORITY|Noninferiority in distance VA was declared if upper confidence limit was less than 0.05.|Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.003|||ONE_SIDED|95.0||-0.01||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, period, sequence, visit, and lens by visit interaction) and random (subject) effects. Difference = LID022821 minus AOHG. Sign is retained with the rounded value.|||-0.01||
71042857|NCT01435928|141594377|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.039|TWO_SIDED|95.0|0.45|0.98|||Log Rank|||||0.98|0.45|0.039
71042858|NCT01435928|141594378|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.07|TWO_SIDED|95.0|0.54|1.03|||Log Rank|||||1.03|0.54|0.070
71042859|NCT01435928|141594379|SUPERIORITY_OR_OTHER|||||||0.029|||||||ANCOVA|LOCF||||||0.029
71042860|NCT01435928|141594380|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANCOVA|LOCF||||||0.015
71042861|NCT01435928|141594381|SUPERIORITY_OR_OTHER|||||||0.218|||||||ANCOVA|LOCF||||||0.218
71042862|NCT01435928|141594382|SUPERIORITY_OR_OTHER|||||||0.021|||||||ANCOVA|LOCF||||||0.021
71042863|NCT01435928|141594383|SUPERIORITY_OR_OTHER|||||||0.056|||||||ANCOVA|LOCF||||||0.056
71042864|NCT04100096|141594455|SUPERIORITY||Least Square (LS) Mean Difference|-1.02||||0.243|TWO_SIDED|95.0|-2.75|0.7||Comparison was carried out using MMRM, with study center (pooled), treatment group (TG), visit, ADT status, and TG by visit interaction (BVI), gender BVI, age BVI as factors and baseline BVI as covariate. An unstructured covariance was used.|MMRM|||||0.70|-2.75|0.2430
71042865|NCT04100096|141594456|SUPERIORITY||LS Mean Difference|-0.04||||0.7759|TWO_SIDED|95.0|-0.35|0.27||Comparison was carried out using MMRM, with study center (pooled), TG, visit, ADT status, and TG BVI, gender BVI, age BVI as factors and baseline BVI as covariate. An unstructured covariance was used.|MMRM|||||0.27|-0.35|0.7759
71042866|NCT04100096|141594457|SUPERIORITY||LS Mean Difference|-0.06||||0.6585|TWO_SIDED|95.0|-0.32|0.2||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|MMRM||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|Week 2||0.20|-0.32|0.6585
71042867|NCT04100096|141594457|SUPERIORITY||LS Mean Difference|-0.25||||0.1181|TWO_SIDED|95.0|-0.57|0.06||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|MMRM||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|Week 4||0.06|-0.57|0.1181
71042868|NCT04100096|141594457|SUPERIORITY||LS Mean Difference|-0.19||||0.2431|TWO_SIDED|95.0|-0.51|0.13||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|MMRM||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|Week 6||0.13|-0.51|0.2431
71042869|NCT04100096|141594457|SUPERIORITY||LS Mean Difference|-0.3||||0.0638|TWO_SIDED|95.0|-0.61|0.02||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|MMRM||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|Week 8||0.02|-0.61|0.0638
71042870|NCT04100096|141594457|SUPERIORITY||LS Mean Difference|-0.11||||0.505|TWO_SIDED|95.0|-0.44|0.22||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|MMRM||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|Week 10||0.22|-0.44|0.5050
71042871|NCT04100096|141594457|SUPERIORITY||LS Mean Difference|-0.14||||0.4277|TWO_SIDED|95.0|-0.48|0.21||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|MMRM||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|Week 12||0.21|-0.48|0.4277
71042872|NCT04100096|141594458|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.6225|TWO_SIDED|95.0|-0.18|0.3||Comparison between TGs was carried out using the Cochran-Mantel-Haenszel (CMH) Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 2||0.30|-0.18|0.6225
71042873|NCT04100096|141594458|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.9145|TWO_SIDED|95.0|-0.35|0.31||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 4||0.31|-0.35|0.9145
71042874|NCT04100096|141594458|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.1535|TWO_SIDED|95.0|-0.52|0.08||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 6||0.08|-0.52|0.1535
71042875|NCT04100096|141594458|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.1922|TWO_SIDED|95.0|-0.5|0.1||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 8||0.10|-0.50|0.1922
71100792|NCT02732145|141709686|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with impaired vulvar skin?||||||0.0006|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with impaired vulvar skin.||||0.0006
71100793|NCT02732145|141709686|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of Hart's Line in patients with vulvar dermatosis?||||||0.0211|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of Hart's Line in patients with vulvar dermatosis.||||0.0211
71100794|NCT02732145|141709686|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Urethral Sulcus in patients with vulvar dermatosis?||||||0.3067|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Urethral Sulcus in patients with vulvar dermatosis.||||0.3067
71100795|NCT02732145|141709686|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Urethral Meatus in patients with vulvar dermatosis?||||||0.0295|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Urethral Meatus in patients with vulvar dermatosis.||||0.0295
71002061|NCT01366534|141511547|OTHER||Vaccine Efficacy: Maentel-Haenzel Method|52.4||||0.0021|TWO_SIDED|95.0|25.4|69.6|||2-sided Fisher Exact test|||Comparison of the efficacy (occurrence of P. falciparum parasitemia, assessed by blood slide) of an immunization regimen comprising of one dose of Ad35.CS.01 vaccine followed one month later by 2 doses of GSK257049 vaccine administered at 1 month intervals, with that of 3 doses of GSK257049 vaccine administered at one month intervals, in healthy malaria-naïve volunteers aged 18-50 years in the sporozoite challenge model.||69.6|25.4|0.0021
71002062|NCT01789255|141511572|OTHER|||||||0.02642|||||||Wilcoxon (Mann-Whitney)|||||||0.02642
71002063|NCT01789255|141511573|OTHER|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
71002064|NCT02635867|141511574|SUPERIORITY|Descriptive data and rates of success were calculated independently for indirect and direct therapies. Statistical analyses of proportions were done using Fisher's test and 95% confidence intervals (CI)|||||>|0.1|||||||Fisher Exact|||"The clinical outcome measures assessed were pain using visual analog pain scale, pulp vitality assessment at 12 months.~The success rate was based on 3 measures of pulp vitality that resulted in a diagnosis of vital or nonvital:~Vital: palpation = negative/ percussion = negative/ response to cold stimuli= positive response Non vital: palpation = positive / percussion = positive. / response to cold stimuli= positive or delayed response time in seconds and lingering."||||>0.1
71002065|NCT02565576|141511576|SUPERIORITY||estimate of contrast posterior median|-1.14|||||TWO_SIDED|90.0|-3.41|1.14|||bayesian|||Primary analysis was performed on the PD analysis set. Changes from baseline in QMG scores at Week 25 were analyzed using a Bayesian model. The model investigated effects for treatment (CFZ533 or placebo) and baseline QMG score. A difference of 3 points on the mean change in QMG score between CFZ533 and placebo was deemed a clinical meaningful effect.||1.14|-3.41|
71002066|NCT03377452|141511587|SUPERIORITY||Mean Difference (Final Values)|7.26|STANDARD_ERROR_OF_MEAN|6.02||0.2313|TWO_SIDED|95.0|-4.71|19.22|||t-test, 2 sided|||||19.22|-4.71|0.2313
71002067|NCT03377452|141511588|SUPERIORITY||Mean Difference (Net)|-3.31|STANDARD_ERROR_OF_MEAN|0.81|<|0.001|TWO_SIDED|95.0|-4.91|-1.72|||Mixed Models Analysis||The parameter estimate is the change in the outcome from baseline to 3-months after the last intervention/control session for the intervention group versus the same change in the control group.|||-1.72|-4.91|<0.001
71002068|NCT03185819|141511629|SUPERIORITY||Difference of LS Means|-5.8|STANDARD_ERROR_OF_MEAN|2.74|=|0.037|TWO_SIDED|95.0|-11.19|-0.35||Threshold for significance for p-value was 0.05.|ANCOVA|||A pooled (54 mg and 84 mg) sequential multiple testing procedure was implemented to control type I error by comparing pooled data against midazolam + placebo matched to esketamine nasal spray.||-0.35|-11.19|= 0.037
71002069|NCT03185819|141511629|SUPERIORITY||Difference of LS Mean|-5.7|STANDARD_ERROR_OF_MEAN|3.65|=|0.123|TWO_SIDED|95.0|-12.91|1.55||Threshold for significance for p-value was 0.05.|ANCOVA|||Individual esketamine dose (84 mg versus medazolam + esketamine matched placebo) independent testing was planned to be performed after pooled (56 mg + 84 mg) analysis.||1.55|-12.91|= 0.123
71002070|NCT03185819|141511629|SUPERIORITY||Difference of LS Means|-5.9|STANDARD_ERROR_OF_MEAN|3.23|=|0.072|TWO_SIDED|95.0|-12.25|0.53||Threshold for significance for p-value was 0.05.|ANCOVA|||Individual esketamine dose (56 mg versus medazolam + esketamine matched placebo) independent testing was planned to be performed after pooled (56 mg + 84 mg) analysis.||0.53|-12.25|= 0.072
71002071|NCT03185819|141511629|SUPERIORITY||Difference of LS Means|-2.4|STANDARD_ERROR_OF_MEAN|3.35|||TWO_SIDED|95.0|-9.08|4.19||||||||4.19|-9.08|
71002072|NCT03375203|141511641|OTHER||Back-transformed Least Square Mean Ratio|0.88|||=|0.346|TWO_SIDED|90.0|0.7|1.1|||ANCOVA|||||1.10|0.70|= 0.346
71002073|NCT03375203|141511641|OTHER||Back-transformed Least Square Mean Ratio|0.64|||=|0.001|TWO_SIDED|90.0|0.51|0.81|||ANCOVA|||||0.81|0.51|= 0.001
71002074|NCT03375203|141511641|OTHER||Back-transformed Least Square Mean Ratio|0.51|||<|0.001|TWO_SIDED|90.0|0.41|0.64|||ANCOVA|||||0.64|0.41|< 0.001
71002075|NCT03375203|141511641|OTHER|||||||0|||||||MCP-mod|||||||0.000
71002076|NCT03321526|141511688|SUPERIORITY|||||||0.5355|TWO_SIDED||||||Log Rank|||||||0.5355
71002077|NCT02910089|141511733|SUPERIORITY|As per the SAP, no p-values were computed. Only point estimates with 95% confidence intervals were evaluated.|Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.2|0.32||As per the SAP, no p-values were computed. Only point estimates with 95% confidence intervals were evaluated.|GEE|Generalized Estimating Equations with an identity link function (as a continuous variable) and normally distributed errors|Model-based Mean Differences are reported that have been adjusted for imbalanced baseline characteristics|||0.32|-0.2|
71002078|NCT02910089|141511734|OTHER||Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.42|4.4||As per the SAP, no p-values were computed. Only point estimates with 95% confidence intervals were evaluated.|GEE|Generalized Estimating Equations with an identity link function and normally distributed errors|Model-based Mean Differences are reported that have been adjusted for imbalanced baseline characteristics|Average of the percentage (proportion x 100) of days covered across all subjects.||4.40|-2.42|
71002079|NCT02910089|141511735|SUPERIORITY||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.83|1.28||As per the SAP, no p-values were computed. Only point estimates with 95% confidence intervals were evaluated.|GEE|Generalized Estimating Equations with a logit link and binary distributed errors||||1.28|0.83|
71002080|NCT02910089|141511736|OTHER|As per the SAP, no p-values were computed. Only point estimates with 95% confidence intervals were evaluated.|Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.71|1.17||As per the SAP, no p-values were computed. Only point estimates with 95% confidence intervals were evaluated.|See comments|Generalized Estimating Equations with a logit link and binary distributed errors||||1.17|0.71|
71002081|NCT04254796|141511737|OTHER|Calculation of the effect size (Cohen's d)|Cohen's d|0.27|||||TWO_SIDED|95.0|-0.13|0.68||||||The goal of the analysis was to measure the effect size of the change in the primary mechanistic outcome (Putamen structural node strength), with a Go/No-Go threshold of Cohen's d \> 0.20.||0.68|-0.13|
71002082|NCT01620593|141511740|SUPERIORITY|t-test|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71002083|NCT01449955|141511780|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||ANOVA comparing the results of change over time (e.g., comparing baseline to 1 month posttreatment) as well as comparing differences between condition (e.g., placebo compared to rapamycin).||||>0.05
71002084|NCT01449955|141511781|SUPERIORITY||||||>|0.5|||||||ANOVA|||||||> 0.5
71002085|NCT01449955|141511782|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||> .05
71002086|NCT01449955|141511783|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||> .05
71002087|NCT01449955|141511784|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||< .05
71002088|NCT01449955|141511785|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||> .05
71002089|NCT01332097|141511786|SUPERIORITY||Least squares mean difference|54.2|||||TWO_SIDED|95.0|-41.7|150.1||||||LS Mean difference: Treatment A vs. Treatment B, E, G \& I (placebo) Day 5||150.1|-41.7|
71002090|NCT01332097|141511786|SUPERIORITY||Least squares mean difference|-52.0|||||TWO_SIDED|95.0|-148.5|44.5||||||LS Mean difference: Treatment C vs. Treatment B, E, G \& I (placebo) Day 5||44.5|-148.5|
71002091|NCT01332097|141511786|SUPERIORITY||Least squares mean difference|5.5|||||TWO_SIDED|95.0|-96.0|106.9||||||LS Mean difference: Treatment D vs. Treatment B, E, G \& I (placebo) Day 5||106.9|-96.0|
71002092|NCT01332097|141511786|SUPERIORITY||Least squares mean difference|33.5|||||TWO_SIDED|95.0|-66.8|133.9||||||LS Mean difference: Treatment F vs. Treatment B, E, G \& I (placebo) Day 5||133.9|-66.8|
71002093|NCT01332097|141511786|SUPERIORITY||Least squares mean difference|99.8|||||TWO_SIDED|95.0|-2.4|202.0||||||LS Mean difference: Treatment H vs. Treatment B, E, G \& I (placebo) Day 5||202.0|-2.4|
71002094|NCT01332097|141511786|SUPERIORITY||Least squares mean difference|37.8|||||TWO_SIDED|95.0|-107.1|182.6||||||LS Mean difference: Treatment A vs. Treatment B, E, G \& I (placebo) Day 10||182.6|-107.1|
71002095|NCT01332097|141511786|SUPERIORITY||Least squares mean difference|-72.0|||||TWO_SIDED|95.0|-215.7|71.8||||||LS Mean difference: Treatment C vs. Treatment B, E, G \& I (placebo) Day 10||71.8|-215.7|
71002096|NCT01332097|141511786|SUPERIORITY||Least squares mean difference|-72.3|||||TWO_SIDED|95.0|-241.5|96.9||||||LS Mean difference: Treatment D vs. Treatment B, E, G \& I (placebo) Day 10||96.9|-241.5|
71002097|NCT01332097|141511786|SUPERIORITY||Least squares mean difference|-17.9|||||TWO_SIDED|95.0|-154.9|119.2||||||LS Mean difference: Treatment F vs. Treatment B, E, G \& I (placebo) Day 10||119.2|-154.9|
71002098|NCT01332097|141511786|SUPERIORITY||Least squares mean difference|123.6|||||TWO_SIDED|95.0|-15.8|263.0||||||LS Mean difference: Treatment H vs. Treatment B, E, G \& I (placebo) Day 10||263.0|-15.8|
71002099|NCT02566109|141511789|OTHER|Estimation of Pearson correlation|Pearson Correlation Coefficient|-0.57472||||0.6102|TWO_SIDED||||||Pearson Correlation Coefficient|||Correlation between baseline and 2 months.||||0.6102
71002100|NCT02566109|141511789|OTHER|Correlation|Pearson Correlation Coefficient|0.25733||||0.8343|TWO_SIDED||||||Peason Correlation Coefficient|||Correlation between baseline and 6 months.||||0.8343
71002101|NCT02566109|141511790|OTHER|Pearson Correlation Coefficient|Pearson Correlation Coefficient|-0.09487||||0.9395|TWO_SIDED||||||Pearson Correlation Coefficient|||Correlation between baseline and 2 months.||||0.9395
71002102|NCT02566109|141511790|OTHER|Pearson Correlation Coefficient|Pearson Correlation Coefficient|0.97287||||0.1486|TWO_SIDED||||||Pearson Correlation Coefficient|||Correlation between baseline and 6 months.||||0.1486
71002103|NCT02566109|141511791|OTHER|Pearson Correlation Coefficient|Pearson Correlation Coefficient|0.10327||||0.9341|TWO_SIDED||||||Pearson Correlation Coefficient|||Correlation between baseline and 2 months.||||0.9341
71002104|NCT02566109|141511791|OTHER|Pearson Correlation Coefficient|Pearson Correlation Coefficient|0.99696||||0.0497|TWO_SIDED||||||Pearson Correlation Coefficient|||Correlation between baseline and 6 months.||||0.0497
71002105|NCT02566109|141511792|OTHER|Pearson Correlation Coefficient|Pearson Correlation Coefficient|0.98432||||0.1129|TWO_SIDED||||||Pearson Correlation Coefficient|||||||0.1129
71002106|NCT02448914|141511817|NON_INFERIORITY_OR_EQUIVALENCE|Analysis was first to attempt to show non-inferiority. To show non-inferiority of TRIGEL over Duodopa, the lower limit of the two-sided CI for the treatment ratio had to be above the chosen non-inferiority margin of 0.9. If non-inferiority was shown, analysis continued with test of superiority. To show superiority of TRIGEL versus Duodopa, the lower confidence limit had to be above 1 (corresponding to a p-value less than 0.05).|back-transformed ratio|1.382|||<|0.0001|TWO_SIDED|95.0|1.264|1.511|||ANCOVA|||Levodopa AUC 0-14h/dose, was derived using the trapezoidal method and divided by the total administered dose of levodopa during the corresponding time interval.The primary endpoint was log transformed and analysed using an ANCOVA, adjusting for treatment, period and patient. The back-transformed ratio of TRIGEL over Duodopa was calculated together with 95% confidence intervals (CI) and the associated (2 sided) p value.||1.511|1.264|<0.0001
71002107|NCT00560794|141511828|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||The null hypothesis stated that the true MRD response probability (π) ≤ 5%.|1-sided exact binomial test|||||||0.0000
71002108|NCT04857892|141511842|OTHER||Ratio of geometric Least Square mean|1.025|||||TWO_SIDED|90.0|0.9335|1.126|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-inf).|||1.126|0.9335|
71002109|NCT04857892|141511842|OTHER||Ratio of geometric Least Square mean|1.072|||||TWO_SIDED|90.0|0.9693|1.185|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-inf).|||1.185|0.9693|
71002110|NCT04857892|141511843|OTHER||Ratio of geometric Least Square mean|1.126|||||TWO_SIDED|90.0|0.9918|1.278|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-t).|||1.278|0.9918|
71002111|NCT04857892|141511843|OTHER||Ratio of geometric Least Square mean|1.055|||||TWO_SIDED|90.0|0.9278|1.201|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-t).|||1.201|0.9278|
71002112|NCT04857892|141511844|OTHER||Ratio of geometric Least Square mean|1.036|||||TWO_SIDED|90.0|0.9209|1.166|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter Cmax.|||1.166|0.9209|
71002113|NCT04857892|141511844|OTHER||Ratio of geometric Least Square mean|1.02|||||TWO_SIDED|90.0|0.9049|1.151|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter Cmax.|||1.151|0.9049|
71002114|NCT04857892|141511845|OTHER||Ratio of geometric Least Square mean|1.129|||||TWO_SIDED|90.0|1.067|1.195|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-inf).|||1.195|1.067|
71002115|NCT04857892|141511845|OTHER||Ratio of geometric Least Square mean|1.112|||||TWO_SIDED|90.0|1.05|1.178|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-inf).|||1.178|1.050|
71002116|NCT04857892|141511846|OTHER||Ratio of geometric Least Square mean|1.164|||||TWO_SIDED|90.0|1.07|1.267|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-t).|||1.267|1.070|
71002117|NCT04857892|141511846|OTHER||Ratio of geometric Least Square mean|1.087|||||TWO_SIDED|90.0|0.9975|1.184|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-t).|||1.184|0.9975|
71002118|NCT04857892|141511847|OTHER||Ratio of geometric Least Square mean|1.078|||||TWO_SIDED|90.0|1.036|1.122|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter Cmax|||1.122|1.036|
71002119|NCT04857892|141511847|OTHER||Ratio of geometric Least Square mean|1.032|||||TWO_SIDED|90.0|0.9914|1.075|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter Cmax|||1.075|0.9914|
71002120|NCT04857892|141511848|OTHER||Ratio of geometric Least Square mean|2.705|||||TWO_SIDED|90.0|2.135|3.427|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-inf)|||3.427|2.135|
71002121|NCT04857892|141511849|OTHER||Ratio of geometric Least Square mean|2.761|||||TWO_SIDED|90.0|2.16|3.527|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-t)|||3.527|2.160|
71002122|NCT04857892|141511850|OTHER||Ratio of geometric Least Square mean|2.498|||||TWO_SIDED|90.0|1.821|3.425|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter Cmax|||3.425|1.821|
71002123|NCT04857892|141511851|OTHER||Ratio of geometric Least Square mean|1.316|||||TWO_SIDED|90.0|1.193|1.451|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-inf)|||1.451|1.193|
71002124|NCT04857892|141511852|OTHER||Ratio of geometric Least Square mean|1.316|||||TWO_SIDED|90.0|1.193|1.452|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-t)|||1.452|1.193|
71002125|NCT04857892|141511853|OTHER||Ratio of geometric Least Square mean|1.232|||||TWO_SIDED|90.0|1.138|1.333|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter Cmax|||1.333|1.138|
71100796|NCT02732145|141709686|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of Hymenal Remnants in patients with vulvar dermatosis?||||||0.0149|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of Hymenal Remnants in patients with vulvar dermatosis.||||0.0149
71100797|NCT02732145|141709686|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis?||||||0.0007|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis.||||0.0007
71100798|NCT02732145|141709686|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Vestibule in patients with vulvar dermatosis?||||||0.0295|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Vestibule in patients with vulvar dermatosis.||||0.0295
71002126|NCT00655811|141511946|SUPERIORITY||||||<|0.05|||||||ANOVA|||One-way anova was used to compare the mean COVAS values between groups.||||<0.05
71002127|NCT00655811|141511946|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.550
71002128|NCT00655811|141511946|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||||||0.005
71002129|NCT00655811|141511946|SUPERIORITY|||||||0.027|||||||t-test, 2 sided|||||||0.027
71002130|NCT00655811|141511947|SUPERIORITY|||||||0.012|||||||t-test, 2 sided|||||||0.012
71002131|NCT00655811|141511947|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
71002132|NCT00655811|141511947|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||0.002
71100799|NCT02732145|141709687|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening between patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening between patients from different groups, with positive AWR.||||0.0000
71100800|NCT02732145|141709687|EQUIVALENCE|Question: Is there a difference in the incidence of coarse AWR between patients from different groups and positive AWR?||||||0.0071|||||||Chi-squared|||Parameter: The difference in the incidence of coarse AWR between patients from different groups and positive AWR.||||0.0071
71002133|NCT00655811|141511948|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
71002134|NCT00394277|141511985|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.075||||0.584||95.0|0.831|1.391||All secondary comparisons were tested at a two-sided significance level of 0.05.|Cochran-Mantel-Haenszel|P-value obtained from CMH test, stratified by country and ribavirin dose strata.||This reflects the primary protocol-specified comparison (standard Pegasys induction dosing arms versus pooled Pegasys induction dosing arms). The study was designed to have at least 86% power for testing the null hypothesis of no difference between these two pooled groups, with assumed response rates of 28%, 32%, 36%, and 43% in the four treatment arms.||1.391|0.831|0.584
71002135|NCT00394277|141511986|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.039||||0.775||95.0|0.803|1.344||All secondary comparisons are tested at a two-sided significance level of 0.05.|Cochran-Mantel-Haenszel|P-value obtained from CMH test, stratified by country and ribavirin dose strata.||(PEG-IFN 180 µg + Ribavirin 1200 mg and PEG-IFN 180 µg + Ribavirin 1400/1600 mg) vs. (PEG-IFN 360/180 µg + Ribavirin 1200 mg and PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg)||1.344|0.803|0.775
71002136|NCT00394277|141511987|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.004||||0.973||95.0|0.777|1.299||All secondary comparisons are tested at a two-sided significance level of 0.05.|Cochran-Mantel-Haenszel|P-value obtained from CMH test, stratified by country and ribavirin dose strata.||(PEG-IFN 180 µg + Ribavirin 1200 mg and PEG-IFN 180 µg + Ribavirin 1400/1600 mg) vs. (PEG-IFN 360/180 µg + Ribavirin 1200 mg and PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg)||1.299|0.777|0.973
71002137|NCT00394277|141511988|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.008||||0.951||95.0|0.78|1.304||All secondary comparisons are tested at a two-sided significance level of 0.05.|Cochran-Mantel-Haenszel|P-value obtained from CMH test, stratified by country and ribavirin dose strata.||(PEG-IFN 180 µg + Ribavirin 1200 mg and PEG-IFN 180 µg + Ribavirin 1400/1600 mg) vs. (PEG-IFN 360/180 µg + Ribavirin 1200 mg and PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg)||1.304|0.780|0.951
71002138|NCT00922974|141511992|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Based on the one-sided exact binomial test with α=0.025 and a 2:1 randomization, 228 patients would be required to detect a 40% improvement in the response rate from 51% (external beam radiation therapy) to 70% (Radiosurgery/SBRT) with a statistical power of 0.80.||||0.99
70924319|NCT04831216|141341150|OTHER|||||||0.6794||||||The p-value reflects results of analysis of change in DMSES scale score from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.6794
70924320|NCT04831216|141341151|OTHER|||||||0.1043||||||The p-value reflects results of analysis of change in oral health behavior from baseline to post-intervention.|Mixed Models Analysis|Cumulative logit mixed effects model included time, age, household size, gender, race, education, and employment.||Cumulative logit mixed effects model (using PROC GLIMMIX) for repeated measures used all available participant data. This model is specifically designed for ordinal outcomes. Analyses do not include imputed missing values.||||0.1043
70924321|NCT04831216|141341152|OTHER||||||<|0.0001||||||The p-value reflects results of analysis of change in PAID-5 scale score from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||<0.0001
70924322|NCT04831216|141341154|OTHER|||||||0.5332||||||The p-value reflects results of analysis of change in number of visits to food pantries in the past 30 days from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.5332
70924323|NCT04831216|141341155|OTHER|||||||0.0468||||||The p-value reflects results of analysis of change in ARMS-D scale scores from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.0468
71100801|NCT02732145|141709687|EQUIVALENCE|Question: Is there a difference in the incidence of slow AWR between patients from different groups and positive AWR?||||||0.001|||||||Chi-squared|||Parameter: The difference in the incidence of slow AWR occurrence between patients from different groups and positive AWR.||||0.0010
70924324|NCT04831216|141341158|OTHER||||||<|0.0001||||||The p-value reflects results of analysis of change in days per week following general healthful diet from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||<0.0001
70924325|NCT04831216|141341159|OTHER|||||||0.0649||||||The p-value reflects results of analysis of change in days per week following specific diet recommendations from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.0649
70924326|NCT04831216|141341160|OTHER|||||||0.0049||||||The p-value reflects results of analysis of change in days per week engaging in exercise from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.0049
70924327|NCT04831216|141341161|OTHER|||||||0.0086||||||The p-value reflects results of analysis of change in days per week conducted blood glucose testing from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.0086
70924328|NCT04831216|141341162|OTHER|||||||0.0243||||||The p-value reflects results of analysis of change in days per week conducting food checks from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.0243
70924329|NCT04831216|141341163|OTHER|||||||0.2861||||||The p-value reflects results of analysis of change in smoking status (yes/no) from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.2861
71100802|NCT02732145|141709687|EQUIVALENCE|Question: Is there a difference in the incidence of provoked erythema among patients from different groups and positive AWR?||||||0.0036|||||||Chi-squared|||Parameter: The difference in the incidence of provoked erythema among patients from different groups and positive AWR.||||0.0036
71100803|NCT02732145|141709687|EQUIVALENCE|Question: Is there a difference in the incidence of sharply bordered AWR between patients from different groups and positive AWR?||||||0.0032|||||||Chi-squared|||Parameter: The difference in the incidence of sharply bordered AWR between patients from different groups and positive AWR.||||0.0032
71100804|NCT02732145|141709687|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Outer Vulvar Ring between the patients from different groups and positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Outer Vulvar Ring between the patients from different groups and positive AWR.||||0.0000
70924330|NCT04831216|141341164|OTHER|||||||0.9933||||||The p-value reflects results of analysis of change in days per week adhering to prescribed medications from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.9933
70924331|NCT03526874|141341165|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||||||0.013
70924332|NCT03526874|141341166|SUPERIORITY|||||||0.031|||||||t-test, 2 sided|||||||0.031
70924333|NCT03526874|141341167|SUPERIORITY|||||||0.0162|||||||ANOVA|Two-way Anova to test sex interaction with treatment effect. The study was not powered for subgroup analyses.||||||0.0162
70924334|NCT03526874|141341168|SUPERIORITY|||||||0.04||||||Two-way Anova to test sex interaction with treatment effect. The study was not powered for subgroup analyses.|ANOVA|||||||0.04
70924335|NCT03526874|141341169|SUPERIORITY|||||||0.0098|||||||ANOVA|Two-way Anova to test ethnicity interaction with treatment effect. The study was not powered for subgroup analyses.||||||0.0098
70924336|NCT03526874|141341170|SUPERIORITY|||||||0.02|||||||ANOVA|Two-way Anova to test ethnicity interaction with treatment effect. The study was not powered for subgroup analyses.||||||0.02
70924337|NCT03526874|141341171|SUPERIORITY|||||||0.01|||||||ANOVA|Two-way Anova to test race interaction with treatment effect. The study was not powered for subgroup analyses.||||||0.01
70924338|NCT03526874|141341172|SUPERIORITY|||||||0.0329|||||||ANOVA|Two-way Anova to test race interaction with treatment effect. The study was not powered for subgroup analyses.||||||0.0329
70924339|NCT03526874|141341173|SUPERIORITY|||||||0.294|||||||t-test, 2 sided|||||||0.294
70924340|NCT03526874|141341174|SUPERIORITY|||||||0.058|||||||t-test, 2 sided|||||||0.058
70924341|NCT03526874|141341175|SUPERIORITY|||||||0.182|||||||t-test, 2 sided|||||||0.182
70924342|NCT03526874|141341176|SUPERIORITY|||||||0.423|||||||Fisher Exact|||||||0.423
70924343|NCT03526874|141341177|SUPERIORITY|||||||0.03|||||||Chi-squared|||||||0.030
70924344|NCT03526874|141341178|SUPERIORITY|||||||0.112|||||||Fisher Exact|||||||0.112
70924345|NCT03526874|141341179|SUPERIORITY|||||||0.052|||||||Fisher Exact|||||||0.052
70924346|NCT03526874|141341180|SUPERIORITY|||||||0.027|||||||Chi-squared|||||||0.027
70924347|NCT04285567|141341206|SUPERIORITY||Difference in Rates|26.6||||0.0004|TWO_SIDED|95.0|12.33|40.87|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using Cochran-Mantel-Haenszel (CMH) test stratified by the IvRS randomization stratification factors.||40.87|12.33|0.0004
70924348|NCT04285567|141341208|SUPERIORITY||Difference in Rates|20.78||||0.0053|TWO_SIDED|95.0|6.66|34.9|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||34.90|6.66|0.0053
70924349|NCT04285567|141341209|SUPERIORITY||Difference in Rates|31.63|||<|0.0001|TWO_SIDED|95.0|16.55|46.71|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||46.71|16.55|< .0001
70924350|NCT04285567|141341210|SUPERIORITY||Difference in Response Rates|9.68||||0.1119|TWO_SIDED|95.0|-2.05|21.41|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||21.41|-2.05|0.1119
70924351|NCT04285567|141341211|SUPERIORITY||Difference in Response Rates|17.44||||0.0154|TWO_SIDED|95.0|1.96|32.93|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||32.93|1.96|0.0154
70924352|NCT04285567|141341212|SUPERIORITY||Difference in Rates|18.93||||0.0054|TWO_SIDED|95.0|0.91|36.95|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||36.95|0.91|0.0054
70924353|NCT04285567|141341213|SUPERIORITY||Difference in Rates|26.79||||0.0038|TWO_SIDED|95.0|3.86|49.72|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||49.72|3.86|0.0038
70924354|NCT04285567|141341215|SUPERIORITY||Difference in Response Rates|3.05||||0.4199|TWO_SIDED|95.0|-5.73|11.84|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||11.84|-5.73|0.4199
70924355|NCT03854578|141341228|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MontgomeryÅsberg Depression Rating Scale (MADRS) ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.08|STANDARD_ERROR_OF_MEAN|0.03||0.0105|TWO_SIDED|90.0|-0.14|-0.03|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Amygdala Left||-0.03|-0.14|0.0105
70924356|NCT03854578|141341228|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.08|STANDARD_ERROR_OF_MEAN|0.03||0.0134|TWO_SIDED|90.0|-0.14|-0.03|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Amygdala Right||-0.03|-0.14|0.0134
70924357|NCT03854578|141341228|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3495|TWO_SIDED|90.0|-0.08|0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Left||0.02|-0.08|0.3495
70924358|NCT03854578|141341228|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.7008|TWO_SIDED|90.0|-0.07|0.04|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex right||0.04|-0.07|0.7008
71002139|NCT00922974|141511993|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.38|TWO_SIDED|95.0|0.72|1.27|||Stratified log rank|One-sided significance level = 0.025.|Reference level = Radiosurgery/SBRT|||1.27|0.72|0.38
71002140|NCT00922974|141511994|SUPERIORITY||Hazard Ratio (HR)|1.73||||0.29|TWO_SIDED|95.0|0.24|12.8|||Stratified log rank|One-sided significance level = 0.025|Significance level = Radiosurgery/SBRT|||12.8|0.24|0.29
71002141|NCT00922974|141511995|SUPERIORITY|||||||0.93||||||Two-sided significance level = 0.05|Chi-squared|||Percentage of patients with treatment-related adverse events.||||0.93
71002142|NCT00922974|141511995|SUPERIORITY|||||||0.09||||||Two-sided significance level = 0.05|Chi-squared|||Percentage of patients with any adverse events.||||0.09
71002143|NCT00922974|141511996|SUPERIORITY|||||||0.59||||||Two-sided significance level = 0.05|Gray's test|||||||0.59
71002144|NCT00922974|141511997|SUPERIORITY|||||||0.38||||||Two-sided significance level = 0.05|Gray's test|||||||0.38
70924359|NCT03854578|141341228|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.6635|TWO_SIDED|90.0|-0.08|0.05|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Left||0.05|-0.08|0.6635
71100805|NCT02732145|141709687|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Middle Vulvar Ring between the patients from different groups and positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Middle Vulvar Ring between the patients from different groups and positive AWR.||||0.0000
71100806|NCT02732145|141709687|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Inner Vulvar Ring between the patients from different groups and positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Inner Vulvar Ring between the patients from different groups and positive AWR.||||0.0000
71100807|NCT02732145|141709687|EQUIVALENCE|"Question: Is there a difference in the incidence of Ring sign between the patients from different groups and positive AWR?"||||||0|||||||Chi-squared|||"Parameter: The difference in the incidence of Ring sign, aceto-whitening of all structures of the Inner Vulvar Ring, between the patients from different groups and positive AWR."||||0.0000
71100808|NCT02732145|141709687|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with vulvar dermatosis and positive AWR?||||||0.0856|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with vulvar dermatosis and positive AWR.||||0.0856
70924360|NCT03854578|141341228|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.8792|TWO_SIDED|90.0|-0.09|0.07|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Right||0.07|-0.09|0.8792
70924361|NCT03854578|141341228|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.08|STANDARD_ERROR_OF_MEAN|0.04||0.0419|TWO_SIDED|90.0|-0.15|-0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Left||-0.02|-0.15|0.0419
70924362|NCT03854578|141341228|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.1658|TWO_SIDED|90.0|-0.12|0.01|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Right||0.01|-0.12|0.1658
71042876|NCT04100096|141594458|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.6488|TWO_SIDED|95.0|-0.4|0.25||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 10||0.25|-0.40|0.6488
71042877|NCT04100096|141594458|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.5992|TWO_SIDED|95.0|-0.4|0.23||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 12||0.23|-0.40|0.5992
71042878|NCT04100096|141594459|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.6579|TWO_SIDED|95.0|-0.29|0.19||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 2||0.19|-0.29|0.6579
71042879|NCT04100096|141594459|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.3728|TWO_SIDED|95.0|-0.43|0.16||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 4||0.16|-0.43|0.3728
71042880|NCT04100096|141594459|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.1684|TWO_SIDED|95.0|-0.5|0.09||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 6||0.09|-0.50|0.1684
71042881|NCT04100096|141594459|SUPERIORITY||Mean Difference (Final Values)|-0.44||||0.0046|TWO_SIDED|95.0|-0.74|-0.13||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 8||-0.13|-0.74|0.0046
71042882|NCT04100096|141594459|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.2087|TWO_SIDED|95.0|-0.51|0.11||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 10||0.11|-0.51|0.2087
70924363|NCT03854578|141341228|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.6673|TWO_SIDED|90.0|-0.08|0.05|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD Signal % change/ Amygdala Left||0.05|-0.08|0.6673
70924364|NCT03854578|141341228|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.07|STANDARD_ERROR_OF_MEAN|0.04||0.0778|TWO_SIDED|90.0|-0.14|-0.01|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD Signal % Change/ Amygdala Right||-0.01|-0.14|0.0778
70924365|NCT03854578|141341228|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3258|TWO_SIDED|90.0|-0.08|0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Left||0.02|-0.08|0.3258
71042883|NCT04100096|141594459|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.0389|TWO_SIDED|95.0|-0.64|-0.02||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 12||-0.02|-0.64|0.0389
71042884|NCT04100096|141594464|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.272|TWO_SIDED|95.0|-0.14|0.5||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 2||0.50|-0.14|0.2720
71042885|NCT04100096|141594464|SUPERIORITY||Mean Difference (Final Values)|1.09||||0|TWO_SIDED|95.0|0.63|1.56||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 4||1.56|0.63|0
71042886|NCT04100096|141594464|SUPERIORITY||Mean Difference (Final Values)|1.18||||0|TWO_SIDED|95.0|0.63|1.73||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons|ANCOVA|||Week 6||1.73|0.63|0
71042887|NCT04100096|141594464|SUPERIORITY||Mean Difference (Final Values)|1.57||||0|TWO_SIDED|95.0|0.92|2.21||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 8||2.21|0.92|0
71042888|NCT04100096|141594464|SUPERIORITY||Mean Difference (Final Values)|1.72||||0|TWO_SIDED|95.0|0.99|2.45||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 10||2.45|0.99|0
71100809|NCT02732145|141709687|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with vulvar dermatosis and positive AWR?||||||0.429|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with vulvar dermatosis and positive AWR.||||0.4290
71100810|NCT02732145|141709687|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with vulvar dermatosis and positive AWR?||||||0.0124|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with vulvar dermatosis and positive AWR.||||0.0124
71100811|NCT02732145|141709687|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with vulvodynia and positive AWR.||||0.0000
70924366|NCT03854578|141341228|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.5954|TWO_SIDED|90.0|-0.07|0.04|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Right||0.04|-0.07|0.5954
71042889|NCT04100096|141594464|SUPERIORITY||Mean Difference (Final Values)|1.44||||0.0002|TWO_SIDED|95.0|0.68|2.19||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 12||2.19|0.68|0.0002
71042890|NCT04100096|141594465|SUPERIORITY||Mean Difference (Final Values)|1.31||||0.062|TWO_SIDED|95.0|-0.07|2.68|||ANCOVA|ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.||Week 12||2.68|-0.07|0.0620
71042891|NCT04100096|141594466|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.4613|TWO_SIDED|95.0|-0.08|0.17|||ANCOVA|ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.||Week 2||0.17|-0.08|0.4613
70924367|NCT03854578|141341228|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.5911|TWO_SIDED|90.0|-0.08|0.04|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Left||0.04|-0.08|0.5911
70924368|NCT03854578|141341228|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.8283|TWO_SIDED|90.0|-0.11|0.08|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Right||0.08|-0.11|0.8283
71100812|NCT02732145|141709687|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with vulvodynia and positive AWR.||||0.0000
71002145|NCT00922974|141511998|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||Assuming that the data are normally distributed, the two sample t-test assuming equal variances will be used to test the hypothesis at the one-sided 0.025 significance level. A mean difference of 7 points represents a clinically meaningful change (CMC). A difference of less than 7 points between the treatment arms will not be considered meaningful, even if it has statistical significance.||||0.28
71002146|NCT00922974|141511999|SUPERIORITY|||||||0.4313|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Treatment Arm (External Beam Radiation Therapy vs. Radiosurgery/SBRT) is reported here.||||0.4313
71002147|NCT00922974|141511999|SUPERIORITY|||||||0.8707|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Age (\< 63 years vs. ≥ 63 years) is reported here.||||0.8707
71002148|NCT00922974|141511999|SUPERIORITY|||||||0.1549|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Gender (female vs. male) is reported here.||||0.1549
71002149|NCT00922974|141511999|SUPERIORITY|||||||0.0193|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Race (Other vs. while) is reported here.||||0.0193
71002150|NCT00922974|141511999|SUPERIORITY|||||||0.0016|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Zubrod performance status (0 vs. 1,2) is reported here.||||0.0016
71002151|NCT00922974|141511999|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Taking pain medication (No vs. Yes) is reported here.||||0.0003
71002152|NCT00922974|141511999|SUPERIORITY|||||||0.6371|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Tumor type (radioresistant vs. other) is reported here.||||0.6371
71042892|NCT04100096|141594466|SUPERIORITY||Mean Difference (Final Values)|0.38||||0|TWO_SIDED|95.0|0.21|0.55||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 4||0.55|0.21|0
71042893|NCT04100096|141594466|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.0001|TWO_SIDED|95.0|0.21|0.61||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 6||0.61|0.21|0.0001
71042894|NCT04100096|141594466|SUPERIORITY||Mean Difference (Final Values)|0.56||||0|TWO_SIDED|95.0|0.33|0.8||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 8||0.80|0.33|0
71042895|NCT04100096|141594466|SUPERIORITY||Mean Difference (Final Values)|0.61||||0|TWO_SIDED|95.0|0.34|0.88||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 10||0.88|0.34|0
71042896|NCT04100096|141594466|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.0004|TWO_SIDED|95.0|0.23|0.8||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 12||0.80|0.23|0.0004
70924369|NCT03854578|141341228|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.1797|TWO_SIDED|90.0|-0.12|0.01|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Left||0.01|-0.12|0.1797
71002153|NCT00922974|141512000|SUPERIORITY|||||||0.0218|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Treatment Arm (External Beam Radiation Therapy vs. Radiosurgery/SBRT) is reported here.||||0.0218
71002154|NCT00922974|141512000|SUPERIORITY|||||||0.9437|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Age (\< 63 years vs. ≥ 63 years) is reported here.||||0.9437
71002155|NCT00922974|141512000|SUPERIORITY|||||||0.0696|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Gender (female vs. male) is reported here.||||0.0696
71002156|NCT00922974|141512000|SUPERIORITY|||||||0.114|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Race (Other vs. while) is reported here.||||0.1140
71002157|NCT00922974|141512000|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Zubrod performance status (0 vs. 1,2) is reported here.||||0.0003
71002158|NCT00922974|141512000|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Taking pain medication (No vs. Yes) is reported here.||||<0.0001
71002159|NCT00922974|141512000|SUPERIORITY|||||||0.7732|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Tumor type (radioresistant vs. other) is reported here.||||0.7732
71002160|NCT00922974|141512001|SUPERIORITY|||||||0.5198|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Treatment Arm (External Beam Radiation Therapy vs. Radiosurgery/SBRT) is reported here.||||0.5198
71002161|NCT00922974|141512001|SUPERIORITY|||||||0.1197|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Age (\< 63 years vs. ≥ 63 years) is reported here.||||0.1197
71042897|NCT04100096|141594468|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.1687|TWO_SIDED|95.0|-0.04|0.25||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 6||0.25|-0.04|0.1687
71042898|NCT04100096|141594468|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.1874|TWO_SIDED|95.0|-0.06|0.29||Analysis of covariance (ANCOVA) model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 12||0.29|-0.06|0.1874
71042899|NCT04100096|141594469|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.0974|TWO_SIDED|95.0|-0.25|0.02||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons|ANCOVA|||Week 6||0.02|-0.25|0.0974
71042900|NCT04100096|141594469|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.391|TWO_SIDED|95.0|-0.2|0.08||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons|ANCOVA|||Week 12||0.08|-0.20|0.3910
71042901|NCT04100096|141594470|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.0063|TWO_SIDED|9.0|0.04|0.26||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 6||0.26|0.04|0.0063
71042902|NCT04100096|141594470|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.067|TWO_SIDED|95.0|-0.01|0.19||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 12||0.19|-0.01|0.0670
71042903|NCT01118026|141594472|SUPERIORITY|||||||0.9669|||||||Log Rank|||||||0.9669
71100813|NCT02732145|141709687|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with vulvodynia and positive AWR?||||||0.1918|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with vulvodynia and positive AWR.||||0.1918
71002162|NCT00922974|141512001|SUPERIORITY|||||||0.0306|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Gender (female vs. male) is reported here.||||0.0306
71002163|NCT00922974|141512001|SUPERIORITY|||||||0.7903|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Race (Other vs. while) is reported here.||||0.7903
71002164|NCT00922974|141512001|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Zubrod performance status (0 vs. 1,2) is reported here.||||<0.0001
71002165|NCT00922974|141512001|SUPERIORITY|||||||0.0026|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Taking pain medication (No vs. Yes) is reported here.||||0.0026
71002166|NCT00922974|141512001|SUPERIORITY|||||||0.3282|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Tumor type (radioresistant vs. other) is reported here.||||0.3282
71002167|NCT02443155|141512009|SUPERIORITY||Treatment ratio|1.48|||=|0.0017|TWO_SIDED|95.0|1.16|1.89|||Mixed model repeated measurements||NNC0114-0006 + liraglutide / Placebo|Ratio of week 54 to baseline are analysed using mixed model for repeated measurements (MMRM) with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.||1.89|1.16|=0.0017
71002168|NCT02443155|141512009|SUPERIORITY||Treatment Ratio|1.23|||=|0.0927|TWO_SIDED|95.0|0.97|1.57|||Mixed model repeated measurements|||Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.||1.57|0.97|=0.0927
71002169|NCT02443155|141512009|SUPERIORITY||Treatment Ratio|1.12|||=|0.378|TWO_SIDED|95.0|0.87|1.42|||Mixed model repeated measurements|||Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.||1.42|0.87|=0.3780
71002170|NCT02443155|141512009|SUPERIORITY||Treatment ratio|1.2|||=|0.1377|TWO_SIDED|95.0|0.94|1.53|||Mixed model repeated measurements|||Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.||1.53|0.94|=0.1377
71002171|NCT02443155|141512009|SUPERIORITY||Treatment ratio|1.33|||=|0.0214|TWO_SIDED|95.0|1.04|1.69|||Mixed model repeated measurements|||Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.||1.69|1.04|=0.0214
71002172|NCT02443155|141512009|SUPERIORITY||Treatmrnt ratio|1.1|||=|0.4187|TWO_SIDED|95.0|0.87|1.41|||Mixed model repeated measurements|||Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.||1.41|0.87|=0.4187
71042904|NCT00831233|141594485|NON_INFERIORITY_OR_EQUIVALENCE|"The trial was positive if the treatment contrast of degarelix versus goserelin plus bicalutamide in adjusted (for baseline total IPSS, age, and country) mean change from baseline in total IPSS was statistically significantly smaller (two-sided at α=0.05 level) than Δ=3 points in both the FAS and the PP analysis set.~If the Week 12 treatment assessment of IPSS was missing the LOCF approach was used, i.e., the IPSS closest to and before Week 12 was used."|Mean Difference (Final Values)|-2.95||||0.1973|TWO_SIDED|95.0|-7.51|1.61||FAS.|ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis.||Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||1.61|-7.51|0.1973
71042905|NCT00831233|141594485|NON_INFERIORITY_OR_EQUIVALENCE|"The trial was positive if the treatment contrast of degarelix versus goserelin plus bicalutamide in adjusted (for baseline total IPSS, age, and country) mean change from baseline in total IPSS was statistically significantly smaller (two-sided at α=0.05 level) than Δ=3 points in both the FAS and the PP analysis set.~If the Week 12 treatment assessment of IPSS was missing the LOCF approach was used, i.e., the IPSS closest to and before Week 12 was used."|Mean Difference (Final Values)|-5.88||||0.0398|TWO_SIDED|95.0|-11.5|-0.291||PP analysis set.|ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis.||Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||-0.291|-11.5|0.0398
71002173|NCT00106249|141512173|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71002174|NCT00106249|141512174|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71002175|NCT03285490|141512268|SUPERIORITY||||||<|0.0001||||||P-value threshold for statistical significance was 0.5%|Cochran-Mantel-Haenszel|||Statistical significance in the study for Day 57 complete clearance rate was analyzed using a Cochran-Mantel-Haenszel model controlling for treatment location (face or scalp) and treatment group (Placebo versus KX2-391 Ointment 1%).||||<0.0001
71002176|NCT03285490|141512269|SUPERIORITY||||||<|0.0001||||||P-value threshold for statistical significance was 0.5%.|Cochran-Mantel-Haenszel|||Statistical significance in the study for Day 57 partial clearance rate was analyzed using a Cochran-Mantel-Haenszel model controlling for treatment location (face or scalp) and treatment group (Placebo versus KX2-391 Ointment 1%).||||<0.0001
71002177|NCT01047436|141512289|SUPERIORITY_OR_OTHER||difference between treatments|26.7||||0.17|TWO_SIDED|95.0|-0.3|53.7|||Fisher Exact|||The sample size was not statistically determined in this initial trial with ArTimist. For the primary outcome analysis, the percentage of patients defined as having success were determined. The difference between ArTiMist and quinine, along with its 95% confidence interval (CI) were determined. The difference between treatments were compared using Fisher's Exact test||53.7|-0.3|0.17
71002178|NCT01047436|141512291|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.7|TWO_SIDED|95.0|0.48|3.01|||Log Rank|||The time for the parasite count to fall by 90% (PCT90) was determined for each patient as the time in minutes/seconds, when the parasite count fell by 90% The PCT90 was appropriately summarised for each treatment for the FAS . The times were presented graphically for each endpoint using a life-table curve (Kaplan-Meier method). For each endpoint the survival curves were compared by the log-rank test. The hazard ratio was calculated along with its 95% CI.||3.01|0.48|0.70
71100814|NCT02732145|141709687|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with impaired vulvar skin and positive AWR.||||0.0000
71100815|NCT02732145|141709687|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with impaired vulvar skin and positive AWR.||||0.0000
71100816|NCT02732145|141709687|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with impaired vulvar skin and positive AWR?||||||0.5822|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with impaired vulvar skin and positive AWR.||||0.5822
71100817|NCT02732145|141709687|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with normal vulva and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with normal vulva and positive AWR.||||0.0000
71100818|NCT02732145|141709687|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with normal vulva and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with normal vulva and positive AWR.||||0.0000
71002179|NCT01047436|141512293|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.76||95.0|0.34|2.18||Difference between survival curves compared by Log Rank test|Log Rank|||The PCT50 was determined for each patient as the time in minutes/seconds, when the parasite count fell by 50% The PCT50 was appropriately summarised for each treatment for the FAS . The times were presented graphically for each endpoint using a life-table curve (Kaplan-Meier method). For each endpoint the survival curves were compared by the log-rank test. The hazard ratio was calculated along with its 95% CI.||2.18|0.34|0.76
71002180|NCT00424099|141512312|OTHER|||||||0.16|||||||Kruskal-Wallis|||||||0.16
71002181|NCT00424099|141512313|OTHER|||||||0.45|||||||Kruskal-Wallis|||||||0.45
71100819|NCT02732145|141709687|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with normal vulva and positive AWR?||||||0.4975|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with normal vulva and positive AWR.||||0.4975
71002182|NCT02280096|141512314|SUPERIORITY||t-boostrap|0.028||||0.028|TWO_SIDED||||||t-test, 1 sided|||||||0.028
71002183|NCT02280096|141512315|SUPERIORITY||t-boostrap|0.001||||0.001|ONE_SIDED||||||t-test, 1 sided|||||||0.001
71100820|NCT02732145|141709688|EQUIVALENCE|Question: Is there a difference in the velocity of the aceto-whitening occurrence among patients from different groups, in which the AWR was positive?||||||0.0003|||||||ANOVA|||Parameter: The difference in the velocity of the aceto-whitening occurrence (positive AWR) among patients from different groups, in which the AWR was positive.||||0.0003
71100821|NCT02732145|141709689|EQUIVALENCE|Question: Is there a difference in the velocity of the aceto-whitening occurrence among patients with positive AWR from different groups?||||||0.0004|||||||Kruskal-Wallis|||Parameter: The difference in the velocity of the aceto-whitening occurrence among patients with positive AWR from different groups.||||0.0004
71100822|NCT02732145|141709689|SUPERIORITY|Question: Is there a difference in the velocity of the aceto-whitening occurrence between patients with vulvar dermatosis and vulvodynia, with positive AWR?||||||0.0231|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the velocity of the aceto-whitening occurrence between patients with vulvar dermatosis and vulvodynia, with positive AWR.||||0.0231
71100823|NCT02732145|141709689|SUPERIORITY|Question: Is there a difference in the velocity of the aceto-whitening occurrence between the patients with normal vulva and impaired vulvar skin, with positive AWR?||||||0.0006|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the velocity of the aceto-whitening occurrence between the patients with normal vulva and impaired vulvar skin, with positive AWR.||||0.0006
71002184|NCT02280096|141512316|SUPERIORITY||t-boostrap|0.016||||0.016|TWO_SIDED||||||t-test, 1 sided|||||||0.016
71002185|NCT02280096|141512317|SUPERIORITY||t-boostrap|0.64||||0.64|ONE_SIDED||||||t-test, 1 sided|||Reading speed||||0.64
71002186|NCT02280096|141512317|SUPERIORITY||t-boostrap|0.43||||0.43|TWO_SIDED||||||t-test, 1 sided|||Count speed||||0.43
71002187|NCT02280096|141512317|SUPERIORITY||t-boostrap|0.9||||0.9|TWO_SIDED||||||t-test, 1 sided|||Alternation||||0.9
71002188|NCT02280096|141512318|SUPERIORITY||t-boostrap|0.83||||0.83|TWO_SIDED||||||t-test, 1 sided|||||||0.83
71002189|NCT02280096|141512319|SUPERIORITY||t-boostrap|0.92||||0.92|ONE_SIDED||||||t-test, 1 sided|||||||0.92
70924370|NCT03854578|141341228|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.5772|TWO_SIDED|90.0|-0.08|0.04|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Right||0.04|-0.08|0.5772
70924371|NCT03854578|141341229|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.09|STANDARD_ERROR_OF_MEAN|0.03||0.0147|TWO_SIDED|90.0|-0.14|-0.03|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Amygdala Left||-0.03|-0.14|0.0147
70924372|NCT03854578|141341229|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.07|STANDARD_ERROR_OF_MEAN|0.03||0.048|TWO_SIDED|90.0|-0.13|-0.01|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Amygdala Right||-0.01|-0.13|0.0480
70924373|NCT03854578|141341229|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.07|STANDARD_ERROR_OF_MEAN|0.03||0.0294|TWO_SIDED|90.0|-0.12|-0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Left||-0.02|-0.12|0.0294
70924374|NCT03854578|141341229|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.07|STANDARD_ERROR_OF_MEAN|0.03||0.0359|TWO_SIDED|90.0|-0.13|-0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Right||-0.02|-0.13|0.0359
70924375|NCT03854578|141341229|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.13|STANDARD_ERROR_OF_MEAN|0.04||0.0022|TWO_SIDED|90.0|-0.19|-0.06|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Left||-0.06|-0.19|0.0022
70924376|NCT03854578|141341229|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.104|TWO_SIDED|90.0|-0.15|0.0|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Right||0.00|-0.15|0.1040
70924377|NCT03854578|141341229|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.12|STANDARD_ERROR_OF_MEAN|0.04||0.0022|TWO_SIDED|90.0|-0.18|-0.06|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Left||-0.06|-0.18|0.0022
70924378|NCT03854578|141341229|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.08|STANDARD_ERROR_OF_MEAN|0.04||0.0331|TWO_SIDED|90.0|-0.14|-0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Right||-0.02|-0.14|0.0331
70924379|NCT03854578|141341229|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.2149|TWO_SIDED|90.0|-0.11|0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Amygdala Left||0.02|-0.11|0.2149
70924380|NCT03854578|141341229|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.6896|TWO_SIDED|90.0|-0.08|0.05|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Amygdala Right||0.05|-0.08|0.6896
71100824|NCT02732145|141709689|SUPERIORITY|Question: Is there a difference in the velocity of the aceto-whitening occurrence between patients with normal vulva and vulvodynia, with positive AWR?||||||0|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the velocity of the aceto-whitening occurrence between patients with normal vulva and vulvodynia, with positive AWR.||||0.0000
70924381|NCT03854578|141341229|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.4769|TWO_SIDED|90.0|-0.06|0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Left||0.02|-0.06|0.4769
70924382|NCT03854578|141341229|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.768|TWO_SIDED|90.0|-0.07|0.05|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Right||0.05|-0.07|0.7680
71002190|NCT02280096|141512320|SUPERIORITY||t-boostrap|0.017||||0.017|TWO_SIDED||||||t-test, 1 sided|||Total moves||||0.017
71002191|NCT02280096|141512320|SUPERIORITY||t-boostrap|0.01||||0.01|TWO_SIDED||||||t-test, 1 sided|||Correct moves||||0.010
71002192|NCT02280096|141512321|SUPERIORITY||t-boostrap|0.001||||0.001|TWO_SIDED||||||t-test, 1 sided|||Execution time||||0.001
71002193|NCT02280096|141512321|SUPERIORITY||t-boostrap|0.001||||0.001|TWO_SIDED||||||t-test, 1 sided|||Problem-solving time||||0.001
71100825|NCT02732145|141709690|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis among patients from different groups, with positive AWR.||||0.0000
70924383|NCT03854578|141341229|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.7997|TWO_SIDED|90.0|-0.08|0.06|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Left||0.06|-0.08|0.7997
70924384|NCT03854578|141341229|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.8334|TWO_SIDED|90.0|-0.08|0.06|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Right||0.06|-0.08|0.8334
70924385|NCT03854578|141341229|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.7402|TWO_SIDED|90.0|-0.07|0.05|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Left||0.05|-0.07|0.7402
70924386|NCT03854578|141341229|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.812|TWO_SIDED|90.0|-0.06|0.08|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Right||0.08|-0.06|0.8120
70924387|NCT05634226|141341246|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
70924388|NCT05634226|141341247|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
70924389|NCT05493423|141341248|NON_INFERIORITY|The null hypothesis is that the difference between the rates of completed hemodialysis sessions for the test and control groups is less than or equal to the non-inferiority margin (indicating inferior success rate). Rejection of the null hypothesis indicates the data supports the alternative hypothesis that the difference between the rates of successfully completed HD sessions for the test and control groups is at least the non-inferiority margin (indicating non-inferior success rate).||||||0.008|||||||Farrington-Manning|non-inferiority margin = 0.08||||||.008
70924390|NCT05493423|141341248|EQUIVALENCE|non-inferiority margin = 0.08||||||0.002|||||||Equivalence Test with paired data|||||||.002
70924391|NCT05493423|141341249|SUPERIORITY|||||||0||||||The p-value was calculated, but was low enough to be rounded down to 0 by the statistical software.|t-test, 2 sided|||||||0
70924392|NCT05493423|141341250|SUPERIORITY|||||||0.84||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.84
70924393|NCT05493423|141341251|SUPERIORITY|||||||0.132|||||||t-test, 2 sided|||||||0.132
71042906|NCT00831233|141594486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.47||||0.2298|TWO_SIDED|95.0|-6.58|1.64|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 4. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||1.64|-6.58|0.2298
71100826|NCT02732145|141709690|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Labia Majora among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Labia Majora among patients from different groups, with positive AWR.||||0.0000
70924394|NCT05493423|141341252|SUPERIORITY|||||||0.84||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.84
70924395|NCT05493423|141341253|SUPERIORITY|||||||0.197||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.197
70924396|NCT05493423|141341254|SUPERIORITY|||||||0.424|||||||t-test, 2 sided|||||||0.424
70924397|NCT05493423|141341255|SUPERIORITY|||||||0||||||The p-value was calculated, but was low enough to be rounded down to 0 by the statistical software.|t-test, 2 sided|||||||0
70924398|NCT05493423|141341256|SUPERIORITY|||||||0||||||The p-value was calculated, but was low enough to be rounded down to as 0 by the statistical software.|t-test, 2 sided|||||||0
70924399|NCT05493423|141341257|SUPERIORITY|||||||0.57||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.57
70924400|NCT05493423|141341258|SUPERIORITY|||||||0||||||The p-value was calculated, but was low enough to be rounded down to 0 by the statistical software.|t-test, 2 sided|||||||0
70924401|NCT05493423|141341259|SUPERIORITY|||||||0.211|||||||t-test, 2 sided|||||||0.211
70924402|NCT05493423|141341260|SUPERIORITY|||||||0.804||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.804
70924403|NCT05493423|141341261|SUPERIORITY|||||||0.307||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.307
70924404|NCT05493423|141341262|SUPERIORITY|||||||0.315||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.315
70924405|NCT06074523|141341271|EQUIVALENCE|Comparing three conditions in a basic science experiment in healthy adults.|partial eta squared|0.81|||<|0.001|TWO_SIDED||||||ANOVA|||Comparing Cued Suppression Task; Positive, Negative, and Neutral Cue condtions||||<.001
70924406|NCT06074523|141341272|EQUIVALENCE|P\<.05 criterion|cohen's d|0.24||||0.08|TWO_SIDED||||||t-test, 2 sided|||Comparing performance on target absent and target present trials||||.08
70924407|NCT06074523|141341273|OTHER||Slope|-0.37||||0.007|TWO_SIDED|95.0|-0.5803|-0.1135|||correlation|||Relationship between Cued Attention Negative Cue Benefit (Neutral Cue RT- Negative Cue RT) and working memory capacity.||-0.1135|-0.5803|.007
71042907|NCT00831233|141594486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.983||||0.6917|TWO_SIDED|95.0|-5.98|4.02|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 8. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||4.02|-5.98|0.6917
71002194|NCT01872897|141512373|SUPERIORITY||Mean Difference (Final Values)|-9.79||||0.0003|TWO_SIDED|95.0|-14.85|-4.74|||Mixed Models Analysis|||||-4.74|-14.85|0.0003
71002195|NCT01872897|141512374|SUPERIORITY||Mean Difference (Final Values)|-15.76|||<|0.0001|TWO_SIDED|95.0|-22.82|-8.71|||Mixed Models Analysis|||||-8.71|-22.82|<0.0001
71002196|NCT01872897|141512375|SUPERIORITY||Median Difference (Final Values)|-19.4||||0.0004|TWO_SIDED|95.0|-29.6|-9.2|||Mixed Models Analysis|||||-9.2|-29.6|0.0004
71002197|NCT01872897|141512376|SUPERIORITY||Mean Difference (Final Values)|-16.3||||0.0019|TWO_SIDED|95.0|-26.2|-6.4|||Mixed Models Analysis|||||-6.4|-26.2|0.0019
71002198|NCT01872897|141512377|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.029|TWO_SIDED|95.0|-1.6|-0.1|||Mixed Models Analysis|||||-0.1|-1.6|0.0290
71042908|NCT00831233|141594487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.553||||0.8151|TWO_SIDED|95.0|-5.33|4.22|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 4. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||4.22|-5.33|0.8151
71002199|NCT01872897|141512378|SUPERIORITY||Mean Difference (Final Values)|-14.4|||<|0.0001|TWO_SIDED|95.0|-20.57|-8.23|||Mixed Models Analysis|||||-8.23|-20.57|<0.0001
71002200|NCT01872897|141512379|SUPERIORITY||Mean Difference (Final Values)|-23.37|||<|0.0001|TWO_SIDED|95.0|-31.55|-15.19|||Mixed Models Analysis|||||-15.19|-31.55|<0.0001
70924408|NCT06074523|141341274|OTHER||Slope|-0.27||||0.046|TWO_SIDED|95.0|-0.5015|-0.002414|||correlation|||Correlation of Inattentive Traits subscale and learned suppression (difference in RT between target absent and target present trials)||-0.002414|-0.5015|.046
71002201|NCT01872897|141512380|SUPERIORITY||Mean Difference (Final Values)|-7.3|||<|0.0001|TWO_SIDED|95.0|-10.0|-4.6|||Mixed Models Analysis|||||-4.6|-10.0|<0.0001
71002202|NCT01872897|141512381|SUPERIORITY||Mean Difference (Final Values)|-6.4||||0.0001|TWO_SIDED|95.0|-9.4|-3.3|||Mixed Models Analysis|||||-3.3|-9.4|0.0001
71002203|NCT01872897|141512382|SUPERIORITY||Mean Difference (Final Values)|-6.3||||0.0075|TWO_SIDED|95.0|-10.9|-1.8|||Mixed Models Analysis|||||-1.8|-10.9|0.0075
71002204|NCT01872897|141512383|SUPERIORITY||Mean Difference (Final Values)|-24.145||||0.0007|TWO_SIDED|95.0|-37.432|-10.858|||Mixed Models Analysis|||||-10.858|-37.432|0.0007
71002205|NCT02418585|141512384|SUPERIORITY||Difference of Least Square (LS) Means|-4.0|STANDARD_ERROR_OF_MEAN|1.69|=|0.02|TWO_SIDED|95.0|-7.31|-0.64|||Mixed Model for Repeated Measures|||||-0.64|-7.31|=0.020
71002206|NCT02418585|141512385|SUPERIORITY||Difference of Least Square (LS) Means|-3.5|||=|0.034|TWO_SIDED|95.0|-6.67|-0.26|||ANCOVA|||||-0.26|-6.67|=0.034
71002207|NCT02040857|141512400|OTHER|Exact binomial test||||||0.0011|||||||Exact binomial test|||Primary objective is treatment discontinuation rate at 2 yr for patients receiving Palbociclib therapy. If the true rate of discontinuation by two years is 48% or higher, treatment duration will be considered not feasible and not worthy of further study. If the rate of discontinuation is 33.3% or less, the 2 yr duration will be deemed feasible and worthy of further study. Using a one-sided alpha = 0.025, there is \> 90% power to reject the null hypothesis in favor of feasibility.||||0.0011
71002208|NCT04159701|141512406|SUPERIORITY||Mean Difference (Final Values)|2.94||||0.38|TWO_SIDED|95.0|-3.73|9.6|||Mixed Models Analysis|||||9.60|-3.73|0.380
70924409|NCT01426425|141341275|SUPERIORITY_OR_OTHER_LEGACY||Chronic effectiveness prob at 6 months|0.926|||<|0.0001|TWO_SIDED|95.0|0.895|0.948|||Kaplan-Meier log-log 95% CI||The chronic effectiveness success probability at 6 months was estimated using the Kaplan-Meier method. The standard error was approximated using Greenwood's formula. A two-sided 95% log-log confidence interval for the probability was constructed.|"The following hypothesis was tested at a one-sided 0.025 significance level.~Ho: PE ≤ 0.83~Ha: PE \> 0.83~Where PE is the probability of a subject achieving chronic effectiveness success at the 6-month follow-up and 0.83 (83%) is the pre-specified performance goal."||0.948|0.895|<0.0001
70924410|NCT01426425|141341276|SUPERIORITY_OR_OTHER_LEGACY||Safety failure probability at 6 months|0.01|||<|0.0001|TWO_SIDED|95.0|0.004|0.027|||Kaplan-Meier log-log 95% CI||The chronic safety failure probability at 6 months was estimated using the Kaplan-Meier method. The standard error was approximated using Greenwood's formula. A two-sided 95% log-log confidence interval for the probability was constructed.|"The following hypothesis was tested at a one-sided 0.025 significance level.~Ho: Ps ≥ 0.07~Ha: Ps \< 0.07~Where Ps is the probability of a subject experiencing at least one safety event through 6 months with a 0.07 pre-specified performance goal."||0.027|0.004|<0.0001
71100827|NCT02732145|141709690|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Perineum among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Perineum among patients from different groups, with positive AWR.||||0.0000
70924411|NCT01426425|141341277|SUPERIORITY_OR_OTHER_LEGACY||Chronic effectiveness prob at 6 months|0.973|||<|0.0001|TWO_SIDED|95.0|0.95|0.985|||Kaplan-Meier log-log 95% CI||The chronic effectiveness success probability at 6 months was estimated using the Kaplan-Meier method. The standard error was approximated using Greenwood's formula. A two-sided 95% log-log confidence interval for the probability was constructed.|"The following hypothesis was tested at a one-sided 0.025 significance level.~Ho: PE ≤ 0.80~Ha: PE \> 0.80~Where PE is the probability of a subject achieving chronic effectiveness success at 6-month follow-up, and 0.80 is the pre-specified performance goal. As pre-defined in the study protocol, this hypothesis is tested if the primary effectiveness objective null hypothesis (Ho) is rejected."||0.985|0.950|<0.0001
70924412|NCT03932682|141341297|OTHER|The primary objective would be achieved if efficacy was demonstrated for at least one of the two primary efficacy endpoints, that is, if the interim analysis-adjusted lower limit of the two-sided confidence interval (CI) for absolute vaccine efficacy (aVE) of QIVc versus the comparator vaccine was greater than 0%.|Cox Proportional Hazard|41.26|||||TWO_SIDED|97.98|21.55|56.02||||||||56.02|21.55|
70924413|NCT03932682|141341298|OTHER|The primary objective would be achieved if efficacy was demonstrated for at least one of the two primary efficacy endpoints, that is, if the interim analysis-adjusted lower limit of the two-sided CI for aVE of QIVc versus the comparator vaccine was greater than 0%.|Cox Proportional Hazard|46.9|||||TWO_SIDED|97.5|19.19|65.11||||||||65.11|19.19|
70924414|NCT03932682|141341299|OTHER|The secondary efficacy objectives were not associated with any hypothesis testing|Cox Proportional Hazard|54.49|||||TWO_SIDED|95.0|22.55|73.26||||||||73.26|22.55|
70924415|NCT03932682|141341300|OTHER|The secondary efficacy objectives were not associated with any hypothesis testing|Cox Proportional Hazard|50.67|||||TWO_SIDED|95.0|32.83|63.77||||||||63.77|32.83|
70924416|NCT03932682|141341301|OTHER|The secondary efficacy objectives were not associated with any hypothesis testing|Cox Proportional Hazard|100.0|||||TWO_SIDED|95.0|||||||"The 2-sided 95% confidence interval was calculated with a lower limit of not estimable and an upper limit of 100."|||||
70924417|NCT03143153|141341326|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.001|TWO_SIDED|98.6|0.46|0.9||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT.|Log Rank||Stratified Cox proportional hazard model.|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy.||0.90|0.46|0.0010
70924418|NCT03143153|141341326|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.001|TWO_SIDED|95.0|0.49|0.84||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT.|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy.||0.84|0.49|0.0010
70924419|NCT03143153|141341326|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|99.5|0.37|0.8||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT.|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.80|0.37|<0.0001
70924420|NCT03143153|141341326|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.41|0.71||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT.|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.71|0.41|<0.0001
70924421|NCT03143153|141341327|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.8958|TWO_SIDED|98.5|0.73|1.43||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy||1.43|0.73|0.8958
70924422|NCT03143153|141341327|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.8958|TWO_SIDED|95.0|0.78|1.34||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy||1.34|0.78|0.8958
71002209|NCT04159701|141512407|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.415|TWO_SIDED|95.0|-1.89|4.5|||Mixed Models Analysis|||||4.50|-1.89|0.415
71002210|NCT04159701|141512408|SUPERIORITY||Mean Difference (Final Values)|1.72||||0.369|TWO_SIDED|95.0|-2.09|5.53|||Mixed Models Analysis|||||5.53|-2.09|0.369
71002211|NCT04159701|141512409|SUPERIORITY||Odds Ratio (OR)|0.61||||0.674|TWO_SIDED|95.0|0.14|2.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted by baseline UAS7 (\< 28 vs \>= 28) score.||||2.70|0.14|0.674
71002212|NCT04159701|141512410|SUPERIORITY||Odds Ratio (OR)|0.59||||0.674|TWO_SIDED|95.0|0.13|2.68|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted by baseline UAS7 (\< median vs \>= median) score.||||2.68|0.13|0.674
71002213|NCT03605836|141512413|SUPERIORITY||Least Squares (LS) Mean Difference|-4.01|||=|0.0021|TWO_SIDED|95.0|-6.55|-1.46|||MMRM||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|||-1.46|-6.55|=0.0021
71002214|NCT03605836|141512413|SUPERIORITY||LS Mean Difference|-4.42|||=|0.0009|TWO_SIDED|95.0|-7.02|-1.82|||MMRM||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|||-1.82|-7.02|=0.0009
71002215|NCT03605836|141512414|SUPERIORITY||LS Mean Difference|-0.33|||=|0.0073|TWO_SIDED|95.0|-0.57|-0.09|||MMRM||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|||-0.09|-0.57|=0.0073
71002216|NCT03605836|141512414|SUPERIORITY||LS Mean Difference|-0.28|||=|0.0245|TWO_SIDED|95.0|-0.53|-0.04|||MMRM||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|||-0.04|-0.53|=0.0245
71002217|NCT02845440|141512424|SUPERIORITY||Odds Ratio (OR)|2.4||||0.013|TWO_SIDED|95.0|1.2|4.79||A priori threshold for significance was p \< 0.05.|Regression, Logistic|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||4.79|1.20|0.013
71002218|NCT02845440|141512424|SUPERIORITY||Odds Ratio (OR)|1.31||||0.481|TWO_SIDED|95.0|0.62|2.74||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||2.74|0.62|0.481
71002219|NCT02845440|141512424|SUPERIORITY||Odds Ratio (OR)|1.84||||0.036|TWO_SIDED|95.0|1.04|3.24||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||3.24|1.04|0.036
71002220|NCT02845440|141512425|SUPERIORITY||Odds Ratio (OR)|1.35||||0.174|TWO_SIDED|95.0|0.88|2.06||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept.||2.06|0.88|0.174
71002221|NCT02845440|141512425|SUPERIORITY||Odds Ratio (OR)|0.69||||0.092|TWO_SIDED|95.0|0.45|1.06||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept.||1.06|0.45|0.092
71002222|NCT02845440|141512426|SUPERIORITY||Odds Ratio (OR)|2.77|||<|0.001|TWO_SIDED|95.0|1.61|4.75||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept.||4.75|1.61|<0.001
71002223|NCT02845440|141512426|SUPERIORITY||Odds Ratio (OR)|0.9||||0.742|TWO_SIDED|95.0|0.5|1.64||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept.||1.64|0.50|0.742
71002224|NCT02845440|141512427|SUPERIORITY||Odds Ratio (OR)|1.57||||0.056|TWO_SIDED|95.0|0.99|2.51||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing abstinence rates at year 2 of intervention were imputed using MICE based on baseline characteristics and abstinence rates at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) as well as TUD medication use and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.|A mediation analysis found that the estimated proportion of the effect of TUD medication use on abstinence rates attributable to the AD+CHW intervention was 2.8%.|2.51|0.99|0.056
71042909|NCT00831233|141594487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46||||0.455|TWO_SIDED|95.0|-2.46|5.38|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 8. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||5.38|-2.46|0.455
71042910|NCT00831233|141594487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.02||||0.3186|TWO_SIDED|95.0|-2.04|6.08|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 12. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||6.08|-2.04|0.3186
71042911|NCT00831233|141594488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.2||||0.5627|TWO_SIDED|95.0|-37.8|68.2|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 4. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||68.2|-37.8|0.5627
71042912|NCT00831233|141594488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.91||||0.8284|TWO_SIDED|95.0|-49.1|60.9|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 8. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||60.9|-49.1|0.8284
71042913|NCT00831233|141594488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.2||||0.5984|TWO_SIDED|95.0|-34.4|58.8|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 12. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||58.8|-34.4|0.5984
71042914|NCT00831233|141594489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.83||||0.1018|TWO_SIDED|95.0|-17.3|1.64|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||1.64|-17.3|0.1018
71042915|NCT02960438|141594505|SUPERIORITY||Difference of arms|2.2||||0.374|TWO_SIDED|95.0|-19.96|24.46|||Regression, Logistic||Estimate was calculated based on the normal approximation to the binomial distribution.|||24.46|-19.96|0.374
71042916|NCT02960438|141594505|SUPERIORITY||Difference of arms|11.1||||0.102|TWO_SIDED|95.0|-7.42|29.64|||Regression, Logistic||Estimate was calculated based on the normal approximation to the binomial distribution.|||29.64|-7.42|0.102
71002225|NCT02845440|141512428|SUPERIORITY||Odds Ratio (OR)|1.97||||0.012|TWO_SIDED|95.0|1.16|3.33||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing abstinence rates at year 2 of intervention were imputed using MICE based on baseline characteristics and abstinence rates at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) as well as varenicline use and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.|A mediation analysis found that the estimated proportion of the effect of varenicline use on abstinence rates attributable to the AD+CHW intervention was 13.9%.|3.33|1.16|0.012
71002226|NCT02845440|141512429|SUPERIORITY||Odds Ratio (OR)|1.71||||0.032|TWO_SIDED|95.0|1.05|2.79||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||2.79|1.05|0.032
71002227|NCT02845440|141512429|SUPERIORITY||Odds Ratio (OR)|1.37||||0.376|TWO_SIDED|95.0|0.68|2.75||The a priori threshold for significance was a p-value \< 0.05.|Regression, Linear|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||2.75|0.68|0.376
71002228|NCT02845440|141512429|OTHER|Test of the additive assumption required by a factorial design. If the AD x CHW interaction is significant at p \< 0.05, the additive assumption would have to be rejected.|Odds Ratio (OR)|1.3||||0.645|TWO_SIDED|95.0|0.42|4.05|||Regression, Logistic|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with both additive terms and an interaction (TAU, AD, CHW, AD x CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||4.05|0.42|0.645
71002229|NCT02845440|141512430|SUPERIORITY||Odds Ratio (OR)|1.85|||<|0.001|TWO_SIDED|95.0|1.34|2.56||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|The CHW intervention increased odds of self-reported use of any TUD medication by 1.85.||The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept.||2.56|1.34|<0.001
71042917|NCT02960438|141594505|SUPERIORITY||Difference of arms|9.3||||0.188|TWO_SIDED|95.0|-9.25|27.77|||Regression, Logistic||Estimate was calculated based on the normal approximation to the binomial distribution.|||27.77|-9.25|0.188
71042918|NCT02322788|141594540|SUPERIORITY_OR_OTHER||Estimated mean ratio|1.87|||<|0.001|TWO_SIDED|95.0|1.52|2.29|||Mixed Models Analysis|||A linear mixed effect model based on restricted maximum likelihood analysis is used to estimate the treatment effect. PC20 in natural log scale is the response variable, treatment and period are the fixed effects, and patient within sequence is a random effect.||2.29|1.52|<0.001
71042919|NCT02322788|141594540|SUPERIORITY_OR_OTHER||Estimated mean ratio|1.79|||<|0.001|TWO_SIDED|95.0|1.46|2.2|||Mixed Models Analysis|||A linear mixed effect model based on restricted maximum likelihood analysis is used to estimate the treatment effect. PC20 in natural log scale is the response variable, treatment and period are the fixed effects, and patient within sequence is a random effect.||2.20|1.46|<0.001
71042920|NCT02322788|141594540|NON_INFERIORITY_OR_EQUIVALENCE|The details of the sample size calculation is document at Section 8.2 the study protocol.|Estimated mean ratio|0.92|||||TWO_SIDED|95.0|0.75|1.13|||Mixed Models Analysis|||A linear mixed effect model based on restricted maximum likelihood analysis is used to estimate the treatment effect. PC20 in natural log scale is the response variable, treatment and period are the fixed effects, and patient within sequence is a random effect.||1.13|0.75|
71042921|NCT02322788|141594540|NON_INFERIORITY_OR_EQUIVALENCE|The details of the sample size calculation is document at Section 8.2 the study protocol.|Estimated mean ratio|0.88|||||TWO_SIDED|95.0|0.72|1.08|||Mixed Models Analysis|||A linear mixed effect model based on restricted maximum likelihood analysis is used to estimate the treatment effect. PC20 in natural log scale is the response variable, treatment and period are the fixed effects, and patient within sequence is a random effect.||1.08|0.72|
71042922|NCT02760264|141594544|OTHER|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."|||
71042923|NCT02760264|141594546|OTHER|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."|||
71002230|NCT02845440|141512430|SUPERIORITY||Odds Ratio (OR)|0.7||||0.084|TWO_SIDED|95.0|0.46|1.05|||Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept.||1.05|0.46|0.084
71042924|NCT02760264|141594548|OTHER|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."|||
71042925|NCT02760264|141594549|OTHER|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."|||
71042926|NCT02760264|141594551|OTHER|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."|||
71042927|NCT02760264|141594553|OTHER|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."|||
71100828|NCT02732145|141709690|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with vulvar dermatosis and positive AWR?||||||0.0128|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with vulvar dermatosis and positive AWR.||||0.0128
70924423|NCT03143153|141341327|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0023|TWO_SIDED|98.5|0.46|0.92||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.92|0.46|0.0023
71100829|NCT02732145|141709690|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with vulvar dermatosis and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with vulvar dermatosis and positive AWR.||||0.0000
70924424|NCT03143153|141341327|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0023|TWO_SIDED|95.0|0.49|0.86||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.86|0.49|0.0023
70924425|NCT03143153|141341328|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.011||95.0|0.65|0.95||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2), PD-L1 status (\>= 1% vs. \< 1% or indeterminate) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy||0.95|0.65|0.0110
70924426|NCT03143153|141341328|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.011||98.2|0.62|0.98||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2), PD-L1 status (\>= 1% vs. \< 1% or indeterminate) as recorded in IRT.|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy||0.98|0.62|0.0110
70924427|NCT03143153|141341328|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0021||99.1|0.58|0.96||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2), PD-L1 status (\>= 1% vs. \< 1% or indeterminate) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.96|0.58|0.0021
70924428|NCT03143153|141341328|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0021|TWO_SIDED|95.0|0.61|0.9||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2), PD-L1 status (\>= 1% vs. \< 1% or indeterminate) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.90|0.61|0.0021
70924429|NCT03143153|141341329|SUPERIORITY||Hazard Ratio (HR)|1.26|||||TWO_SIDED|95.0|1.04|1.52|||||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy||1.52|1.04|
70924430|NCT03143153|141341329|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0355|TWO_SIDED|95.0|0.67|0.99||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2), PD-L1 status (\>= 1% vs. \< 1% or indeterminate) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.99|0.67|0.0355
70924431|NCT03143153|141341329|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0355|TWO_SIDED|98.5|0.64|1.04||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2), PD-L1 status (\>= 1% vs. \< 1% or indeterminate) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||1.04|0.64|0.0355
70924432|NCT02312557|141341331|OTHER||Proportion|0.19|||<|0.01|TWO_SIDED|95.0|0.09|0.29|||One-sample binomial test of proportion|||||0.29|0.09|<0.01
70924433|NCT05285618|141341366|OTHER|A linear mixed model accounted for repeated measures ('subject\_id' as a random factor). No power calculation was performed, but the sample size (1,485 observations, 6 subjects) supports robust estimation.||||||0.002||||||P-values are unadjusted for multiple comparisons, as the analysis focused on a limited number of predictors. The a priori threshold for statistical significance was set at p\<0.05.|Mixed Models Analysis|||The model tested whether stimulation delay ('abs\_delay'), retinal distance ('dist\_ret'), and their interaction ('abs\_delay:dist\_ret') affect the number of elicited phosphenes ('num\_phosphenes').|We hypothesize that the parameter 'dist\_ret' may influence the number of phosphenes perceived ('num\_phosphenes'), while the roles of 'abs\_delay' and its interaction with 'dist\_ret' may be less pronounced. Further evaluation of these parameters will be conducted in the Results section|||0.002
70924434|NCT04556656|141341375|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.162||0.167|TWO_SIDED|95.0|-0.54|0.09|||Mixed Models Analysis|||In the mixed model for repeated measures (MMRM), change from baseline in TFC score was the dependent variable, and independent variables included treatment arm, baseline TFC, region, neuroleptic use or no use, baseline HD stage (HD1 and HD2), categorical week, and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. The unstructured covariance matrix was used for repeated measurements at patient level.||0.09|-0.54|0.1670
70924435|NCT04556656|141341376|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.162||0.1598|TWO_SIDED|95.0|-0.55|0.09|||Mixed Models Analysis|||In the mixed model for repeated measures (MMRM), change from baseline in TFC score was the dependent variable, and independent variables included treatment arm, baseline TFC, region, neuroleptic use or no use, baseline HD stage (HD1 and HD2), categorical week, and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. The unstructured covariance matrix was used for repeated measurements at patient level.||0.09|-0.55|0.1598
70924436|NCT04556656|141341377|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.148||0.4544|TWO_SIDED|95.0|-0.4|0.18|||Mixed Models Analysis|||In the MMRM, change in cUHDRS score from baseline was the dependent variable, while independent variables included treatment arm, baseline cUHDRS, region, neuroleptic use or no use, baseline HD stage (HD1 and HD2), categorical week, and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. The unstructured covariance matrix was used for repeated measurements at patient level. No imputation was performed on missing data.||0.18|-0.4|0.4544
71100830|NCT02732145|141709690|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with vulvar dermatosis and positive AWR?||||||0.0635|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with vulvar dermatosis and positive AWR.||||0.0635
70924437|NCT04556656|141341378|SUPERIORITY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.156||0.0038|TWO_SIDED|95.0|0.15|0.76|||Mixed Models Analysis|||"From baseline to Week 26.~In the MMRM model, change in cUHDRS score from baseline was the dependent variable and independent variables included treatment group, baseline cUHDRS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, concomitant use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data."||0.76|0.15|0.0038
70924438|NCT04556656|141341378|SUPERIORITY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.179||0.0135|TWO_SIDED|95.0|0.09|0.8|||Mixed Models Analysis|||From baseline to Week 39||0.80|0.09|0.0135
71002231|NCT02845440|141512430|OTHER|Test of the additive assumption required by a factorial design. If the AD x CHW interaction is significant at p \< 0.05, the additive assumption would have to be rejected.|Odds Ratio (OR)|1.22||||0.589|TWO_SIDED|95.0|0.59|2.55|||Regression, Logistic|||The statistical model was a mixed effects logistic regression with both additive terms and an interaction (TAU, AD, CHW, AD x CHW, and cohort) and a clinic-varying random intercept.||2.55|0.59|0.589
71002232|NCT02845440|141512431|SUPERIORITY||Odds Ratio (OR)|3.05|||<|0.001|TWO_SIDED|95.0|1.99|4.68||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept.||4.68|1.99|<0.001
71042928|NCT05918822|141594561|OTHER|A mixed-effects model was applied to log (ln)-transformed plasma maribavir Cmax with treatment, period, and sequence as fixed effects, and participant within sequence as random effect. Point estimates and their associated 90% confidence intervals (CIs) were constructed for differences between Treatment B (test) versus Treatment A (reference). Point estimate and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment B versus Treatment A.|Geometric Mean Ratio (GMR) (%)|82.19|||||TWO_SIDED|90.0|74.31|90.91|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of Cmax of Maribavir: Part 1: Treatment B (Test) versus Treatment A (Reference)||90.91|74.31|
70924439|NCT04556656|141341378|SUPERIORITY||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.193||0.0351|TWO_SIDED|95.0|0.03|0.79|||Mixed Models Analysis|||From baseline to Week 52||0.79|0.03|0.0351
70924440|NCT04556656|141341378|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.197||0.1683|TWO_SIDED|95.0|-0.12|0.66|||Mixed Models Analysis|||From baseline to Week 65.||0.66|-0.12|0.1683
70924441|NCT04556656|141341378|SUPERIORITY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.223||0.5315|TWO_SIDED|95.0|-0.3|0.58|||Mixed Models Analysis|||From baseline to Week 78||0.58|-0.30|0.5315
71042929|NCT05918822|141594561|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir Cmax with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90 percent (%) CIs were constructed for differences between Treatment C (test) versus Treatment B (reference). Point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment C versus Treatment B.|Geometric Mean Ratio (GMR) (%)|57.72|||||TWO_SIDED|90.0|52.18|63.84|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of Cmax of Maribavir: Part 1: Treatment C (Test) versus Treatment B (Reference)||63.84|52.18|
71042930|NCT05918822|141594561|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir Cmax with treatment as a fixed effect, and participant as a random effect. Point estimates and their associated 90% CIs were constructed for the differences between Treatment E (test) versus Treatment D (reference). The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for the ratios of Treatment E versus Treatment D.|Geometric Mean Ratio (GMR) (%)|49.03|||||TWO_SIDED|90.0|40.07|60.0|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of Cmax of Maribavir: Part 2: Treatment E (Test) versus Treatment D (Reference)||60.00|40.07|
71042931|NCT05918822|141594562|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir AUClast with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs were constructed for differences between Treatment B (test) versus Treatment A (reference). Point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment B versus Treatment A.|Geometric Mean Ratio (GMR) (%)|97.59|||||TWO_SIDED|90.0|91.39|104.2|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of AUClast of Maribavir: Part 1: Treatment B (Test) versus Treatment A (Reference)||104.20|91.39|
71042932|NCT05918822|141594562|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir AUClast with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs were constructed for differences between Treatment C (test) versus Treatment B (reference). Point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment C versus Treatment B.|Geometric Mean Ratio (GMR) (%)|82.05|||||TWO_SIDED|90.0|76.84|87.61|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of AUClast of Maribavir: Part 1: Treatment C (Test) versus Treatment B (Reference)||87.61|76.84|
71042933|NCT05918822|141594562|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir AUClast with treatment as a fixed effect, and participant as a random effect. Point estimates and their associated 90% CIs were constructed for the differences between Treatment E (test) versus Treatment D (reference). The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for the ratios of Treatment E versus Treatment D.|Geometric Mean Ratio (GMR) (%)|70.0|||||TWO_SIDED|90.0|60.11|81.51|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of AUClast of Maribavir: Part 2: Treatment E (Test) versus Treatment D (Reference)||81.51|60.11|
70924442|NCT04556656|141341379|SUPERIORITY||Mean Difference (Final Values)|-21.15|STANDARD_ERROR_OF_MEAN|9.406||0.0253|TWO_SIDED|95.0|-39.66|-2.64|||Mixed Models Analysis||Negative change = improvement.|From baseline to Week 26. In the MMRM model, change in Q-Motor Finger Tapping IOI Mean from baseline was the dependent variable and independent variables included treatment group, baseline Finger Tapping IOI Mean, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, concomitant use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed.||-2.64|-39.66|0.0253
70924443|NCT04556656|141341379|SUPERIORITY||Mean Difference (Final Values)|-14.31|STANDARD_ERROR_OF_MEAN|9.853||0.1474|TWO_SIDED|95.0|-33.71|5.08|||Mixed Models Analysis|||From baseline to Week 52.||5.08|-33.71|0.1474
70924444|NCT04556656|141341379|SUPERIORITY||Mean Difference (Final Values)|-24.71|STANDARD_ERROR_OF_MEAN|10.185||0.0159|TWO_SIDED|95.0|-44.76|-4.67|||Mixed Models Analysis|||From baseline to Week 65.||-4.67|-44.76|0.0159
70924445|NCT04556656|141341379|SUPERIORITY||Mean Difference (Final Values)|-22.9|STANDARD_ERROR_OF_MEAN|10.38||0.0283|TWO_SIDED|95.0|-43.34|-2.45|||Mixed Models Analysis|||From baseline to Week 78.||-2.45|-43.34|0.0283
71002233|NCT02845440|141512431|SUPERIORITY||Odds Ratio (OR)|0.89||||0.698|TWO_SIDED|95.0|0.51|1.57||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept.||1.57|0.51|0.698
71002234|NCT02845440|141512431|OTHER|Test of the additive assumption required by a factorial design. If the AD x CHW interaction is significant at p \< 0.05, the additive assumption would have to be rejected.|Odds Ratio (OR)|1.1||||0.845|TWO_SIDED|95.0|0.43|2.78|||Regression, Logistic|||The statistical model was a mixed effects logistic regression with both additive terms and an interaction (TAU, AD, CHW, AD x CHW, and cohort) and a clinic-varying random intercept.||2.78|0.43|0.845
71002235|NCT02845440|141512432|SUPERIORITY||Odds Ratio (OR)|1.42||||0.158|TWO_SIDED|95.0|0.92|2.2||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing abstinence rates at year 2 of intervention were imputed using MICE based on baseline characteristics and abstinence rates at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) as well as TUD medication use and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.|A mediation analysis found that the estimated proportion of the effect of TUD medication use on abstinence rates attributable to the CHW intervention was 55.6%.|2.20|0.92|0.158
71002236|NCT02845440|141512433|SUPERIORITY||Odds Ratio (OR)|1.89||||0.013|TWO_SIDED|95.0|1.14|3.13||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing abstinence rates at year 2 of intervention were imputed using MICE based on baseline characteristics and abstinence rates at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) as well as varenicline use and a clinic-varying random intercept. Regression coefficients and mediation analysis estimates were pooled using Rubin's rule over 10 imputation runs.|A mediation analysis found that the estimated proportion of the effect of varenicline use on abstinence rates attributable to the CHW intervention was 36.6%.|3.13|1.14|0.013
71002237|NCT02845440|141512434|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.505|TWO_SIDED|95.0|-0.16|0.33|||Regression, Linear|||The model had a clinic varying random intercept. This statistical model included cohort 1: TAU , AD, and AD+CHW||0.33|-0.16|0.505
71002238|NCT02845440|141512434|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.848|TWO_SIDED|95.0|-0.22|0.27||The a priori threshold for significance was a p-value \< 0.05.|Regression, Linear|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects linear regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||0.27|-0.22|0.848
71100831|NCT02732145|141709690|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with vulvodynia and positive AWR?||||||0.0429|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with vulvodynia and positive AWR.||||0.0429
71002239|NCT02845440|141512434|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.529|TWO_SIDED|95.0|-0.13|0.25||The a priori threshold for significance was a p-value \< 0.05.|Regression, Linear|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects linear regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||0.25|-0.13|0.529
70924446|NCT04556656|141341380|SUPERIORITY||Mean Difference (Final Values)|-38.06|STANDARD_ERROR_OF_MEAN|10.999||0.0007|TWO_SIDED|95.0|-59.74|-16.37|||Mixed Models Analysis|||From baseline to Week 26. In MMRM model, change in Q-Motor Pronation/Supination ITI Mean from baseline was the dependent variable and independent variables included treatment group, baseline Q-Motor Pronation/Supination ITI Mean, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||-16.37|-59.74|0.0007
70924447|NCT04556656|141341380|SUPERIORITY||Mean Difference (Final Values)|-20.21|STANDARD_ERROR_OF_MEAN|12.547||0.1087|TWO_SIDED|95.0|-44.95|4.53|||Mixed Models Analysis|||From baseline to Week 52.||4.53|-44.95|0.1087
70924448|NCT04556656|141341380|SUPERIORITY||Mean Difference (Final Values)|-23.92|STANDARD_ERROR_OF_MEAN|11.541||0.0395|TWO_SIDED|95.0|-46.68|-1.16|||Mixed Models Analysis|||From baseline to Week 65.||-1.16|-46.68|0.0395
70924449|NCT04556656|141341380|SUPERIORITY||Mean Difference (Final Values)|-22.23|STANDARD_ERROR_OF_MEAN|13.587||0.1038|TWO_SIDED|95.0|-49.08|4.61|||Mixed Models Analysis|||From baseline to Week 78.||4.61|-49.08|0.1038
71002240|NCT02845440|141512435|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.937|TWO_SIDED|95.0|-0.16|0.18|||Regression, Linear|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects linear regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||0.18|-0.16|0.937
71100832|NCT02732145|141709690|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with vulvodynia and positive AWR?||||||0.0011|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with vulvodynia and positive AWR.||||0.0011
71100833|NCT02732145|141709690|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with vulvodynia and positive AWR?||||||0.0936|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with vulvodynia and positive AWR.||||0.0936
70924450|NCT04556656|141341381|SUPERIORITY||Mean Difference (Final Values)|-30.38|STANDARD_ERROR_OF_MEAN|12.902||0.0193|TWO_SIDED|95.0|-55.78|-4.98|||Mixed Models Analysis|||From baseline to Week 26. In the MMRM model, change in Pronation/Supination IOI Mean from BL was the dependent variable and independent variables included treatment group, BL Pronation/Supination IOI Mean, region, categorical week, baseline HD stage (HD1 and HD2), treatment by categorical week interaction, conc. use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||-4.98|-55.78|0.0193
70924451|NCT04556656|141341381|SUPERIORITY||Mean Difference (Final Values)|-16.84|STANDARD_ERROR_OF_MEAN|15.17||0.268|TWO_SIDED|95.0|-46.69|13.02|||Mixed Models Analysis|||From baseline to Week 52.||13.02|-46.69|0.2680
70924452|NCT04556656|141341381|SUPERIORITY||Mean Difference (Final Values)|-22.79|STANDARD_ERROR_OF_MEAN|14.829||0.1255|TWO_SIDED|95.0|-51.97|6.4|||Mixed Models Analysis|||From baseline to Week 65.||6.4|-51.97|0.1255
71002241|NCT02845440|141512435|SUPERIORITY||Median Difference (Final Values)|0.05||||0.683|TWO_SIDED|95.0|-0.19|0.29|||Regression, Linear|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects linear regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||0.29|-0.19|0.683
71002242|NCT02845440|141512435|OTHER|Test of the additive assumption required by a factorial design. If the AD x CHW interaction is significant at p \< 0.05, the additive assumption would have to be rejected.|Mean Difference (Final Values)|0.3||||0.19|TWO_SIDED|95.0|-0.15|0.74|||Regression, Linear|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects linear regression with both additive terms and an interaction (TAU, AD, CHW, AD x CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||0.74|-0.15|0.190
71002243|NCT02057068|141512436|SUPERIORITY||||||<|0.001|||||||ANOVA|Intention to treat analysis with last observation carried forward|||Partial Eta Squared = .282|||<.001
71002244|NCT02057068|141512437|SUPERIORITY|Intention to treat analysis with last observation carried forward|||||>|0.05|||||||ANOVA|||||||>.05
71002245|NCT02057068|141512438|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
71002246|NCT01704976|141512454|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
71002247|NCT01704976|141512455|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
71002248|NCT01704976|141512456|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
71002249|NCT01704976|141512457|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
71002250|NCT01704976|141512458|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
71002251|NCT00329784|141512459|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71002252|NCT00329784|141512459|SUPERIORITY_OR_OTHER|||||||0.004|||||||Chi-squared|||||||0.004
71002253|NCT00329784|141512460|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71002254|NCT00329784|141512461|SUPERIORITY_OR_OTHER|||||||0.369|||||||Wilcoxon (Mann-Whitney)|||||||0.369
71002255|NCT00329784|141512462|SUPERIORITY_OR_OTHER|||||||0.642|||||||Chi-squared|||||||0.642
71002256|NCT00329784|141512463|SUPERIORITY_OR_OTHER|||||||0.417|||||||Chi-squared|||Comparison for Seasonal Rhinoconjunctivitis||||0.417
71002257|NCT00329784|141512463|SUPERIORITY_OR_OTHER|||||||0.926|||||||Chi-squared|||Comparison for Perennial Rhinoconjunctivitis||||0.926
71002258|NCT00329784|141512464|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Comparison for Peanut Wheal||||<0.001
71002259|NCT00329784|141512464|SUPERIORITY_OR_OTHER|||||||0.361|||||||Chi-squared|||Comparison for Egg Wheal||||0.361
71002260|NCT00329784|141512464|SUPERIORITY_OR_OTHER|||||||0.76|||||||Chi-squared|||Comparison for Milk Wheal||||0.760
71002261|NCT00329784|141512464|SUPERIORITY_OR_OTHER|||||||0.834|||||||Chi-squared|||Comparison for Sesame Wheal||||0.834
71002262|NCT00329784|141512464|SUPERIORITY_OR_OTHER|||||||0.882|||||||Chi-squared|||Comparison for Brazil Nut Wheal||||0.882
71100834|NCT02732145|141709690|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with impaired vulvar skin and positive AWR?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with impaired vulvar skin and positive AWR.||||1.0000
71002263|NCT00329784|141512464|SUPERIORITY_OR_OTHER|||||||0.226|||||||Chi-squared|||Comparison for Hazel Nut Wheal||||0.226
71002264|NCT00329784|141512464|SUPERIORITY_OR_OTHER|||||||0.024|||||||Chi-squared|||Comparison for Cashew Wheal||||0.024
71002265|NCT00329784|141512464|SUPERIORITY_OR_OTHER|||||||0.204|||||||Chi-squared|||Comparison for Walnut Wheal||||0.204
71002266|NCT00329784|141512464|SUPERIORITY_OR_OTHER|||||||0.194|||||||Chi-squared|||Comparison for Almond Wheal||||0.194
71002267|NCT00329784|141512465|SUPERIORITY_OR_OTHER|||||||0.859|||||||Chi-squared|||Comparison for Peanut IgE||||0.859
71002268|NCT00329784|141512465|SUPERIORITY_OR_OTHER|||||||0.885|||||||Chi-squared|||Comparison for Egg IgE||||0.885
71002269|NCT00329784|141512465|SUPERIORITY_OR_OTHER|||||||0.403|||||||Chi-squared|||Comparison for Milk IgE||||0.403
71002270|NCT00329784|141512465|SUPERIORITY_OR_OTHER|||||||0.106|||||||Chi-squared|||Comparison for Sesame IgE||||0.106
71002271|NCT00329784|141512465|SUPERIORITY_OR_OTHER|||||||0.202|||||||Chi-squared|||Comparison for Brazil Nut IgE||||0.202
71002272|NCT00329784|141512465|SUPERIORITY_OR_OTHER|||||||0.108|||||||Chi-squared|||Comparison for Hazel Nut IgE||||0.108
71002273|NCT00329784|141512465|SUPERIORITY_OR_OTHER|||||||0.157|||||||Chi-squared|||Comparison for Cashew IgE||||0.157
70924453|NCT04556656|141341381|SUPERIORITY||Mean Difference (Final Values)|-22.72|STANDARD_ERROR_OF_MEAN|17.777||0.2024|TWO_SIDED|95.0|-57.72|12.28|||Mixed Models Analysis|||From baseline to Week 78.||12.28|-57.72|0.2024
70924454|NCT04556656|141341382|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.179||0.2088|TWO_SIDED|95.0|-0.13|0.58|||Mixed Models Analysis|||"From baseline to Week 26.~In the MMRM model, change in UHDRS-TFC score from baseline was the dependent variable and independent variables included treatment group, Baseline UHDRS-TFC, region, categorical week, Baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, concomitant use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data."||0.58|-0.13|0.2088
71002274|NCT00329784|141512465|SUPERIORITY_OR_OTHER|||||||0.04|||||||Chi-squared|||Comparison for Walnut IgE||||0.040
71002275|NCT00329784|141512465|SUPERIORITY_OR_OTHER|||||||0.262|||||||Chi-squared|||Comparison for Almond IgE||||0.262
71002276|NCT00654420|141512476|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.268|TWO_SIDED|95.0|0.47|1.57|||Finkelstein Proportional Hazards Model|||Finkelstein proportional hazards model for interval-censored data was used to assess treatment effect on PFS in Phase II. The hazard ratio with 95% confidence interval for the Dalotuzumab (10 mg/kg) + Erlotinib treatment arm compared to the Erlotinib treatment arm was reported.||1.57|0.47|0.268
71002277|NCT00654420|141512477|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.44||||0.879|TWO_SIDED|95.0|0.78|2.64|||Regression, Cox|||The treatment difference in survival between treatment groups was assessed by Cox regression. The estimated hazard ratio for treatment of the Dalotuzumab (10 mg/kg) + Erlotinib treatment arm compared to the Erlotinib treatment arm was reported from the Cox model.||2.64|0.78|0.879
71002278|NCT00654420|141512478|SUPERIORITY_OR_OTHER||Difference in Percentage|-2.8||||0.721|TWO_SIDED|95.0|-15.9|9.4|||Miettinen & Nurminen Method|||Miettinen and Nurminen's method for stratified data was used for comparison of percentage of participants with objective response (ORR) between the two treatment groups. Response rate calculation was based on full follow-up.||9.4|-15.9|0.721
71002279|NCT00471276|141512481|SUPERIORITY_OR_OTHER||Objective Response Rate (percent)|8.4|||||TWO_SIDED|95.0|3.5|16.6|||Exact 2-sided confidence interval|||||16.6|3.5|
71002280|NCT00471276|141512482|SUPERIORITY_OR_OTHER||Objective Response Rate (percent)|10.8|||||TWO_SIDED|95.0|5.1|19.6|||Exact 2-sided confidence interval|||||19.6|5.1|
71100835|NCT02732145|141709690|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with impaired vulvar skin and positive AWR?||||||0.0429|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with impaired vulvar skin and positive AWR.||||0.0429
71100836|NCT02732145|141709690|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with impaired vulvar skin and positive AWR?||||||0.0429|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with impaired vulvar skin and positive AWR.||||0.0429
71002281|NCT01594411|141512501|SUPERIORITY_OR_OTHER||||||<|0.001|||||||one-sided binomial with alpha level of 0|||"The proportion of patients whose final treatment plan changes from the preliminary will be estimated, and a one-sided binomial test with alpha level of .05 will be used to test whether it is greater than 10%.~This is the level at which it is assumed that patient management has been modified by a practically important amount."||||<0.001
71002282|NCT00838383|141512502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-70.0||||0.5307|TWO_SIDED|95.0|-291.3|151.4|||ANCOVA|||||151.4|-291.3|0.5307
71002283|NCT00838383|141512502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-73.2||||0.5121|TWO_SIDED|95.0|-294.5|148.2|||ANCOVA|||||148.2|-294.5|0.5121
71002284|NCT00838383|141512503|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-123.1||||0.2735|TWO_SIDED|95.0|-345.5|99.3|||ANCOVA|||||99.3|-345.5|0.2735
71002285|NCT00838383|141512503|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-174.5||||0.1223|TWO_SIDED|95.0|-396.8|47.9|||ANCOVA|||||47.9|-396.8|0.1223
71002286|NCT00838383|141512504|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-66.6||||0.5505|TWO_SIDED|95.0|-288.0|154.8|||ANCOVA|||||154.8|-288.0|0.5505
71002287|NCT00838383|141512504|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-110.3||||0.3237|TWO_SIDED|95.0|-331.7|111.0|||ANCOVA|||||111.0|-331.7|0.3237
71002288|NCT00838383|141512505|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-166.5||||0.1412|TWO_SIDED|95.0|-389.6|56.6|||ANCOVA|||||56.6|-389.6|0.1412
71002289|NCT00838383|141512505|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-199.8||||0.0813|TWO_SIDED|95.0|-425.0|25.5|||ANCOVA|||||25.5|-425.0|0.0813
71002290|NCT00431496|141512536|SUPERIORITY_OR_OTHER||Percentage of participants|42.3||||||95.0|30.8|53.7||||||||53.7|30.8|
71002291|NCT00431496|141512537|SUPERIORITY_OR_OTHER||Percentage of participants|52.1||||||95.0|40.5|63.7||||||||63.7|40.5|
71002292|NCT00431496|141512538|SUPERIORITY_OR_OTHER||Percentage of participants|78.9||||||95.0|69.4|88.4||||||||88.4|69.4|
71002293|NCT00431496|141512539|SUPERIORITY_OR_OTHER||Percentage of participants|54.9||||||95.0|43.4|66.5||||||||66.5|43.4|
71002294|NCT00431496|141512540|SUPERIORITY_OR_OTHER||Percentage of participants|53.5||||||95.0|41.9|65.1||||||||65.1|41.9|
71002295|NCT00431496|141512541|SUPERIORITY_OR_OTHER||Percentage of participants|46.5||||||95.0|34.9|58.1||||||||58.1|34.9|
71002296|NCT01248585|141512544|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.053||0.05|TWO_SIDED|90.0|0.0|0.177||1-sided p-value.|Cochran-Mantel-Haenszel|||One-sided 0.05 level test with 90% power, 298 participants required.||0.177|0|0.05
71002297|NCT01248585|141512545|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.009||||0.432|TWO_SIDED|95.0|-0.08|0.1|||Cochran-Mantel-Haenszel|||||0.10|-0.08|0.432
71100837|NCT02732145|141709691|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure among patients from different groups, with positive AWR.||||0.0000
71002298|NCT01248585|141512547|SUPERIORITY||Risk Difference (RD)|0.09||||0.15|TWO_SIDED|90.0|0.01|0.18||Fisher exact test.|Fisher Exact|||||0.18|0.01|0.15
71002299|NCT01248585|141512548|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.55||||0.07|TWO_SIDED|90.0|-5.06|3.97|||Wilcoxon (Mann-Whitney)|||||3.97|-5.06|0.07
70924455|NCT04556656|141341382|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.188||0.2991|TWO_SIDED|95.0|-0.17|0.57|||Mixed Models Analysis|||From baseline to Week 39.||0.57|-0.17|0.2991
71002300|NCT00880607|141512564|OTHER|Wilcoxon rank-sum test because the outcome variable was found to have a skewed distribution.|Median Difference (Final Values)|7.7||||0.27|TWO_SIDED|95.0|-5.8|21.2||Hodges-Lehmanne estimation method|Wilcoxon (Mann-Whitney)||Hodges-Lehmanne estimation method|||21.2|-5.8|.27
71002301|NCT00880607|141512565|OTHER|Log-rank test in Kaplan-Meier used.||||||0.42|TWO_SIDED|95.0|||||Log Rank|||||||.42
70924456|NCT04556656|141341382|SUPERIORITY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.205||0.2116|TWO_SIDED|95.0|-0.15|0.66|||Mixed Models Analysis|||From baseline to Week 52.||0.66|-0.15|0.2116
70924457|NCT04556656|141341382|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.215||0.8242|TWO_SIDED|95.0|-0.38|0.47|||Mixed Models Analysis|||From baseline to Week 65.||0.47|-0.38|0.8242
71002302|NCT00880607|141512567|OTHER|||||||0.08|||||||Chi-squared|||||||0.08
71042934|NCT05918822|141594563|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir AUC0-infinity with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs were constructed for differences between Treatment B (test) versus Treatment A (reference). Point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment B versus Treatment A.|Geometric Mean Ratio (GMR) (%)|99.94|||||TWO_SIDED|90.0|94.12|106.11|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of AUC0-infinity of Maribavir: Part 1: Treatment B (Test) versus Treatment A (Reference)||106.11|94.12|
71042935|NCT05918822|141594563|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir AUC0-infinity with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs were constructed for differences between Treatment C (test) versus Treatment B (reference). Point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment C versus Treatment B.|Geometric Mean Ratio (GMR) (%)|81.68|||||TWO_SIDED|90.0|76.93|86.73||||||Comparison of AUC0-infinity of Maribavir: Part 1: Treatment C (Test) versus Treatment B (Reference)||86.73|76.93|
71042936|NCT05918822|141594563|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir AUC0-infinity with treatment as a fixed effect, and participant as a random effect. Point estimates and their associated 90% CIs were constructed for the differences between Treatment E (test) versus Treatment D (reference). The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for the ratios of Treatment E versus Treatment D.|Geometric Mean Ratio (GMR) (%)|88.92|||||TWO_SIDED|90.0|76.94|102.78|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of AUC0-infinity of Maribavir: Part 2: Treatment E (Test) versus Treatment D (Reference)||102.78|76.94|
71042937|NCT01796964|141594567|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority at week 12 is concluded at one-sided alpha level of 0.10 if the lower limit of the corresponding two-sided 80% confidence interval for the treatment difference (ESBA 1008 - EYLEA) is greater than -5 letters.|Treatment difference (ESBA - Eylea)|-1.13|||||TWO_SIDED|80.0|-4.19|1.93|||||Treatment differences were based on least squares estimates.|An analysis of variance (ANOVA) model with treatment and baseline BCVA categories (\< 55 and ≥ 55 letters) as class variables was used to estimate the treatment group differences (ESBA1008 - EYLEA) in the primary efficacy endpoint, BCVA Change from baseline to Week 12.||1.93|-4.19|
71042938|NCT01796964|141594568|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority at week 16 is concluded at one-sided alpha level of 0.10 if the lower limit of the corresponding two-sided 80% confidence interval for the treatment difference (ESBA 1008 - EYLEA) is greater than -5 letters.|Treatment difference (ESBA - Eylea)|-0.58|||||TWO_SIDED|80.0|-3.72|2.56|||||Treatment differences were based on least squares estimates.|An analysis of variance (ANOVA) model with treatment and baseline BCVA categories (\< 55 and ≥ 55 letters) as class variables was used to estimate the treatment group differences (ESBA1008 - EYLEA) in the primary efficacy endpoint, BCVA Change from baseline to Week 16.||2.56|-3.72|
71042939|NCT04025684|141594576|SUPERIORITY||Adjusted Mean Change|-0.1|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.11|-0.08||Analysis was performed using ANCOVA Model with product group as a fixed effect and the baseline mean RPI overall value as a covariate.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.08|-0.11|<.0001
71042940|NCT04025684|141594576|SUPERIORITY||Adjusted Mean Change|-0.12|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.14|-0.1||Analysis was performed using ANCOVA model with product group as a fixed effect and the baseline mean RPI overall value as a covariate.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.10|-0.14|<0.0001
71002303|NCT00880607|141512568|OTHER|||||||0.3|||||||Chi-squared|||||||0.30
71002304|NCT00880607|141512569|OTHER|||||||0.07|||||||Chi-squared|||||||0.07
71002305|NCT00880607|141512570|OTHER|||||||0.31|||||||Chi-squared|||||||0.31
71002306|NCT02963766|141512573|SUPERIORITY||LS Mean difference (Final Values)|-1.3|||<|0.001|TWO_SIDED|95.0|-1.8|-0.7|||Mixed Models Analysis|||||-0.7|-1.8|<0.001
71002307|NCT02963766|141512574|SUPERIORITY||LS Mean difference (Final Values)|-1.0||||0.002|TWO_SIDED|95.0|-1.7|-0.4|||Mixed Models Analysis|||||-0.4|-1.7|0.002
71002308|NCT02963766|141512574|SUPERIORITY||LS Mean difference (Final Values)|-1.5|||<|0.001|TWO_SIDED|95.0|-2.2|-0.9|||Mixed Models Analysis|||||-0.9|-2.2|<0.001
70924458|NCT04556656|141341382|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.231||0.5918|TWO_SIDED|95.0|-0.33|0.58|||Mixed Models Analysis|||From baseline to Week 78.||0.58|-0.33|0.5918
71002309|NCT02963766|141512575|SUPERIORITY||LS Mean difference (Final Values)|-1.44||||0.021|TWO_SIDED|95.0|-2.65|-0.22|||Mixed Models Analysis|||||-0.22|-2.65|0.021
71002310|NCT02963766|141512575|SUPERIORITY||LS Mean difference (Final Values)|-2.51|||<|0.001|TWO_SIDED|95.0|-3.72|-1.29|||Mixed Models Analysis|||||-1.29|-3.72|<0.001
71002311|NCT02963766|141512575|SUPERIORITY||LS Mean difference (Final Values)|-1.97|||<|0.001|TWO_SIDED|95.0|-3.03|-0.91|||Mixed Models Analysis|||||-0.91|-3.03|<0.001
71002312|NCT02963766|141512576|SUPERIORITY||Odds Ratio (OR)|11.038|||<|0.001|TWO_SIDED|95.0|3.491|34.902|||Regression, Logistic|||||34.902|3.491|<0.001
70924459|NCT04556656|141341383|SUPERIORITY||Mean Difference (Final Values)|3.16|STANDARD_ERROR_OF_MEAN|1.326||0.0178|TWO_SIDED|95.0|0.55|5.77|||Mixed Models Analysis|||From baseline to Week 26. In the MMRM model, change in SWR score from baseline was the dependent variable and independent variables included treatment group, baseline SWR, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, concomitant use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||5.77|0.55|0.0178
70924460|NCT04556656|141341383|SUPERIORITY||Mean Difference (Final Values)|2.89|STANDARD_ERROR_OF_MEAN|1.518||0.0576|TWO_SIDED|95.0|-0.09|5.88|||Mixed Models Analysis|||From baseline to Week 39.||5.88|-0.09|0.0576
70924461|NCT04556656|141341383|SUPERIORITY||Mean Difference (Final Values)|3.05|STANDARD_ERROR_OF_MEAN|1.493||0.0418|TWO_SIDED|95.0|0.11|5.99|||Mixed Models Analysis|||From baseline to Week 52.||5.99|0.11|0.0418
70924462|NCT04556656|141341383|SUPERIORITY||Mean Difference (Final Values)|2.32|STANDARD_ERROR_OF_MEAN|1.719||0.1775|TWO_SIDED|95.0|-1.06|5.71|||Mixed Models Analysis|||From baseline to Week 65.||5.71|-1.06|0.1775
70924463|NCT04556656|141341383|SUPERIORITY||Mean Difference (Final Values)|1.99|STANDARD_ERROR_OF_MEAN|1.772||0.2627|TWO_SIDED|95.0|-1.5|5.48|||Mixed Models Analysis|||From baseline to Week 78.||5.48|-1.50|0.2627
70924464|NCT04556656|141341384|SUPERIORITY||Mean Difference (Final Values)|1.01|STANDARD_ERROR_OF_MEAN|0.712||0.1586|TWO_SIDED|95.0|-0.4|2.41|||Mixed Models Analysis|||From baseline to Week 26. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||2.41|-0.4|0.1586
70924465|NCT04556656|141341384|SUPERIORITY||Mean Difference (Final Values)|0.87|STANDARD_ERROR_OF_MEAN|0.701||0.2144|TWO_SIDED|95.0|-0.51|2.25|||Mixed Models Analysis|||From baseline to Week 39. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||2.25|-0.51|0.2144
70924466|NCT04556656|141341384|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.793||0.9119|TWO_SIDED|95.0|-1.65|1.48|||Mixed Models Analysis|||From baseline to Week 52. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||1.48|-1.65|0.9119
70924467|NCT04556656|141341384|SUPERIORITY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.844||0.7339|TWO_SIDED|95.0|-1.38|1.95|||Mixed Models Analysis|||From baseline to Week 65. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||1.95|-1.38|0.7339
70924468|NCT04556656|141341384|SUPERIORITY||Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.859||0.6213|TWO_SIDED|95.0|-1.27|2.12|||Mixed Models Analysis|||From baseline to Week 78. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||2.12|-1.27|0.6213
70924469|NCT04556656|141341385|SUPERIORITY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.777||0.8205|TWO_SIDED|95.0|-1.71|1.36|||Mixed Models Analysis|||From baseline to Week 26. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||1.36|-1.71|0.8205
70924470|NCT04556656|141341385|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|1.067||0.4028|TWO_SIDED|95.0|-3.0|1.21|||Mixed Models Analysis|||From baseline to Week 39. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||1.21|-3.0|0.4028
70924471|NCT04556656|141341385|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|1.051||0.7577|TWO_SIDED|95.0|-2.4|1.75|||Mixed Models Analysis|||From baseline to Week 52. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||1.75|-2.4|0.7577
71002313|NCT02963766|141512576|SUPERIORITY||Odds Ratio (OR)|11.666|||<|0.001|TWO_SIDED|95.0|3.653|37.253|||Regression, Logistic|||||37.253|3.653|<0.001
71002314|NCT02963766|141512576|SUPERIORITY||Odds Ratio (OR)|11.348|||<|0.001|TWO_SIDED|95.0|4.163|30.932|||Regression, Logistic|||||30.932|4.163|<0.001
71002315|NCT02963766|141512577|SUPERIORITY||LS Mean difference (Final Values)|-0.1||||0.689|TWO_SIDED|95.0|-0.7|0.5|||Mixed Models Analysis|||||0.5|-0.7|0.689
71002316|NCT02963766|141512577|SUPERIORITY||LS Mean difference (Final Values)|0.0||||0.924|TWO_SIDED|95.0|-0.6|0.5|||Mixed Models Analysis|||||0.5|-0.6|0.924
71002317|NCT02963766|141512577|SUPERIORITY||LS Mean difference (Final Values)|-0.1||||0.776|TWO_SIDED|95.0|-0.6|0.4|||Mixed Models Analysis|||||0.4|-0.6|0.776
71002318|NCT00499460|141512589|SUPERIORITY|The primary hypothesis being tested is that garlic powder treatment increases metabolic clearance of oxycodone through enzyme induction and results in lower exposure to oxycodone.|||||>|0.05||||||Significance probability for the treatment variable in the Generalized Linear Model|Generalized Estimating Equations|Response variable is oxycodone oral clearance. Explanatory variables include treatment, period and gender, along with their interaction terms.||||||>0.05
70924472|NCT04556656|141341385|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|1.158||0.7605|TWO_SIDED|95.0|-2.64|1.93|||Mixed Models Analysis|||From baseline to Week 65. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||1.93|-2.64|0.7605
70924473|NCT04556656|141341385|SUPERIORITY||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|1.323||0.6694|TWO_SIDED|95.0|-2.05|3.18|||Mixed Models Analysis|||From baseline to Week 78. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||3.18|-2.05|0.6694
70924474|NCT05722704|141341386|SUPERIORITY||Median Difference (Net)|0.118|STANDARD_DEVIATION|0.05||0.986|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.986
70924475|NCT05722704|141341387|SUPERIORITY||Median Difference (Net)|0.016|STANDARD_DEVIATION|0.05|<|0.118|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||<0.118
70924476|NCT05722704|141341388|SUPERIORITY||Median Difference (Net)|95.0|STANDARD_DEVIATION|0.05||0.225|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.225
70924477|NCT05722704|141341389|SUPERIORITY||Median Difference (Net)|95.0|STANDARD_DEVIATION|0.05||0.424|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.424
70924478|NCT03498651|141341396|SUPERIORITY||Mean Difference (Net)|1.1|STANDARD_DEVIATION|0.03|||TWO_SIDED|95.0|1.04|1.16|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% bootstrap confidence interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation)."||1.16|1.04|
70924479|NCT03498651|141341396|SUPERIORITY||Mean Difference (Net)|-0.12|STANDARD_DEVIATION|0.16|||TWO_SIDED|95.0|-0.43|0.2|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% HPD credible interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach)."||0.20|-0.43|
70924480|NCT03498651|141341397|SUPERIORITY||Mean Difference (Net)|-0.63|STANDARD_DEVIATION|0.03|||TWO_SIDED|95.0|-0.69|-0.57|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% bootstrap confidence interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation)."||-0.57|-0.69|
71042941|NCT04025684|141594576|SUPERIORITY||Adjusted Mean Change|-0.1|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.12|-0.08||Analysis was performed using ANCOVA model with product group as a fixed effect and the baseline mean RPI overall value as a covariate.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.08|-0.12|<0.0001
71042942|NCT04025684|141594576|SUPERIORITY||Adjusted Mean Change|-0.1|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.12|-0.08||Analysis was performed using ANCOVA model with product group as a fixed effect and the baseline mean RPI overall value as a covariate.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.08|-0.12|<0.0001
71042943|NCT04025684|141594577|SUPERIORITY||Adjusted Mean Change|-0.5|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001|TWO_SIDED|95.0|-0.62|-0.37||Analysis was performed using ANCOVA model with product group as a fixed effect, and the baseline mean TPI overall value and RPI stratification level as covariates.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.37|-0.62|<0.0001
71042944|NCT04025684|141594577|SUPERIORITY||Adjusted Mean Change|-0.62|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.75|-0.49||Analysis was performed using ANCOVA model with product group as a fixed effect, and the baseline mean TPI overall value and RPI stratification level as covariates.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.49|-0.75|<0.0001
71042945|NCT04025684|141594577|SUPERIORITY||Adjusted Mean Change|-0.55|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.68|-0.42||Analysis was performed using ANCOVA model with product group as a fixed effect, and the baseline mean TPI overall value and RPI stratification level as covariates.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.42|-0.68|<0.0001
70924481|NCT03498651|141341397|SUPERIORITY||Mean Difference (Net)|0.06|STANDARD_DEVIATION|0.17|||TWO_SIDED|95.0|-0.26|0.39|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% HPD credible interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach)."||0.39|-0.26|
71002319|NCT00499460|141512590|SUPERIORITY|The secondary hypothesis being tested is that powder garlic treatment lowers Cold Pressor Test tolerance (i.e., diminished analgesic response) after oxycodone administration due to a more rapid metabolic clearance and lower exposure to oxycodone.|||||>|0.05||||||Significance probability for the treatment variable in the Generalized Linear Model|Generalized Estimating Equations|Response variable is log Tolerance AUC. Explanatory variables include treatment, period and gender, along with their interaction terms.||||||>0.05
71002320|NCT00499460|141512591|SUPERIORITY|The secondary hypothesis being tested is that garlic powder treatment lowers opioid side effects after oxycodone administration due to a more rapid metabolic clearance and lower exposure to oxycodone.|||||>|0.05||||||Significance probability for the treatment variable in the Generalized Linear Model|Generalized Estimating Equations|Response variable is total SSE rating score. Explanatory variables include treatment, period, time and gender, along with their interaction terms.||||||>0.05
71002321|NCT00499460|141512592|SUPERIORITY|The secondary hypothesis being tested is that garlic powder treatment lowers opioid side effects after oxycodone administration due to a more rapid metabolic clearance and lower exposure to oxycodone.|||||>|0.05||||||Significance probability for the treatment variable in the Generalized Linear Model|Generalized Estimating Equations|Response variable is total CASE rating score. Explanatory variables include treatment, period, time and gender, along with their interaction terms.||||||>0.05
71002322|NCT00499460|141512593|SUPERIORITY||||||>|0.05|||||||t-test, 1 sided|Garlic powder versus placebo||The secondary hypothesis being tested is that garlic powder induces CYP3A-mediated metabolism resulting in a lower oral midazolam AUC.||||>0.05
71002323|NCT00499460|141512594|SUPERIORITY|The secondary hypothesis being tested is that garlic powder treatment induces intestinal P-glycoprotein, reduces the bioavailability and hence AUC of orally administered digoxin.|||||>|0.05|||||||t-test, 1 sided|Garlic powder versus placebo||||||>0.05
71002324|NCT00814307|141512595|SUPERIORITY_OR_OTHER||Percent difference|39.04|||<|0.0001|TWO_SIDED|95.0|29.12|48.95||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690,550 to placebo.||48.95|29.12|<0.0001
71002325|NCT00814307|141512595|SUPERIORITY_OR_OTHER||Percent difference|33.08|||<|0.0001|TWO_SIDED|95.0|23.04|43.13||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690,550 to placebo.||43.13|23.04|<0.0001
71042946|NCT04025684|141594577|SUPERIORITY||Adjusted Mean Change|-0.57|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.7|-0.44||Analysis was performed using ANCOVA model with product group as a fixed effect, and the baseline mean TPI overall value and RPI stratification level as covariates.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.44|-0.70|<0.0001
71042947|NCT01844531|141594593|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|97.92|STANDARD_ERROR_OF_MEAN|8.4||0|TWO_SIDED|90.0|93.529|102.52||Model included effects:sequence;subjects within sequences;period and treatment with subjects within sequences as random effect.|ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUCinfpred \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA). The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale.||102.520|93.529|0.0000
71042948|NCT01844531|141594593|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|98.0|STANDARD_ERROR_OF_MEAN|8.3|<|0.0001|TWO_SIDED|90.0|93.57|102.65||Model included effects:sequence;subjects within sequences;period and treatment with all effects as fixed.|ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUCinfpred \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA). The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale.||102.65|93.57|<.0001
71042949|NCT01844531|141594593|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|102.79|STANDARD_ERROR_OF_MEAN|6.7||0|TWO_SIDED|90.0|99.077|106.633||Model included effects:sequence;subjects within sequences;period and treatment with subjects within sequences as random effect.|ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500 , PK set AUCinfpred \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA). The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale.||106.633|99.077|0.0000
71042950|NCT01844531|141594593|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|102.5|STANDARD_ERROR_OF_MEAN|6.7|<|0.0001|TWO_SIDED|90.0|98.78|106.36|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa5 (T2) : Empa5 + Met500 (R2), PK set AUCinfpred \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||106.36|98.78|<.0001
71002326|NCT00814307|141512596|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.38|||<|0.0001|TWO_SIDED|95.0|-0.5|-0.27||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in ACR20 had to be significant.|Linear mixed effect model|||p-value was calculated using linear mixed effect model. The fixed effects of treatment, visit, and treatment-by-visit interaction were included, along with participant as random effect.||-0.27|-0.50|<.0001
71002327|NCT00814307|141512596|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.31|||<|0.0001|TWO_SIDED|95.0|-0.43|-0.2||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in ACR20 had to be statistically significant.|Linear mixed effect model|||p-value was calculated using linear mixed effect model. The fixed effects of treatment, visit, and treatment-by-visit interaction were included, along with participant as random effect.||-0.20|-0.43|<0.0001
71002328|NCT00814307|141512597|SUPERIORITY_OR_OTHER||Percent difference|5.24||||0.0728|TWO_SIDED|95.0|-0.49|10.96||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in HAQ-DI had to be significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690550 to placebo.||10.96|-0.49|0.0728
71002329|NCT00814307|141512597|SUPERIORITY_OR_OTHER||Percent difference|1.31||||0.6193|TWO_SIDED|95.0|-3.85|6.46||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690550 to placebo.||6.46|-3.85|0.6193
71042951|NCT01844531|141594594|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|96.25|STANDARD_ERROR_OF_MEAN|15.4||0.0006|TWO_SIDED|90.0|88.542|104.628|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUCinfpred \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||104.628|88.542|0.0006
71002330|NCT01256918|141512641|SUPERIORITY_OR_OTHER||incidence|0.0|||>|0.05|||||||incidence|||"Any occurence of posterior capsular rupture in attempted vertical chop would have been an indicator of overzealous penetration as the vertical chop even though effective would not have been safe.~We hypothesised that use of callibrated phacotip after careful preoperative assessment for performing vertical chop during phacoemulsification is not associated with any posterior capsular rupture we noted any incidence of posterior capsular rupture."||||>0.05
71002331|NCT01256918|141512642|SUPERIORITY_OR_OTHER||pearson correlation coefficient|0.850958|||<|0.05|||||||pearson correlation coefficient|||null hypothesis : there is no correlation between nuclear colour and phacodepth required for a full thickness crack during a vertical chop||||<0.05
71002332|NCT01256918|141512643|SUPERIORITY_OR_OTHER||pearson correlation coefficient|0.842617|||<|0.05|||||||pearson correlation coefficient|||"Null hypothesis:~there is no correlation between nuclear opalescence and phacodepth required to achieve full thickness nuclear crack using a callibrated phacotip."||||<0.05
70924482|NCT03498651|141341398|SUPERIORITY||Mean Difference (Net)|0.48|STANDARD_DEVIATION|0.03|||TWO_SIDED|95.0|0.42|0.54|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.||"Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation)."|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% bootstrap confidence interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|0.54|0.42|
70924483|NCT03498651|141341398|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_DEVIATION|0.16|||TWO_SIDED|95.0|-0.23|0.39|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% HPD credible interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach)."||0.39|-0.23|
71100838|NCT02732145|141709691|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci among patients from different groups, with positive AWR.||||0.0000
71100839|NCT02732145|141709691|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Labia Minora among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Labia Minora among patients from different groups, with positive AWR.||||0.0000
71100840|NCT02732145|141709691|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Posterior Commissure among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Posterior Commissure among patients from different groups, with positive AWR.||||0.0000
71100841|NCT02732145|141709691|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with vulvar dermatosis and positive AWR?||||||0.0318|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with vulvar dermatosis and positive AWR.||||0.0318
71100842|NCT02732145|141709691|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with vulvar dermatosis and positive AWR?||||||0.0318|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with vulvar dermatosis and positive AWR.||||0.0318
71100843|NCT02732145|141709691|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with vulvar dermatosis and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with vulvar dermatosis and positive AWR.||||0.0000
71100844|NCT02732145|141709691|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with vulvar dermatosis and positive AWR?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with vulvar dermatosis and positive AWR.||||1.0000
71100845|NCT02732145|141709691|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci versus Posterior Commissure in patients with vulvar dermatosis and positive AWR?||||||0.0389|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci versus Posterior Commissure in patients with vulvar dermatosis and positive AWR.||||0.0389
71100846|NCT02732145|141709691|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with vulvar dermatosis and positive AWR?||||||0.0389|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with vulvar dermatosis and positive AWR.||||0.0389
71100847|NCT02732145|141709691|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with vulvodynia and positive AWR?||||||1e-05|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with vulvodynia and positive AWR.||||0.00001
71100848|NCT02732145|141709691|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with vulvodynia and positive AWR.||||0.0000
71100849|NCT02732145|141709691|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with vulvodynia and positive AWR.||||0.0000
71100850|NCT02732145|141709691|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Interlabial Sulci versus Labia Minora in patients with vulvodynia and positive AWR?||||||0.0008|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Interlabial Sulci versus Labia Minora in patients with vulvodynia and positive AWR.||||0.0008
71100851|NCT02732145|141709691|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Interlabial Sulci versus Posterior Commissure in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Interlabial Sulci versus Posterior Commissure in patients with vulvodynia and positive AWR.||||0.0000
71100852|NCT02732145|141709691|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Labia Minora versus Posterior Commissure in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Labia Minora versus Posterior Commissure in patients with vulvodynia and positive AWR.||||0.0000
71100853|NCT02732145|141709691|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with impaired vulvar skin and positive AWR?||||||0.0005|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with impaired vulvar skin and positive AWR.||||0.0005
71100854|NCT02732145|141709691|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with impaired vulvar skin and positive AWR.||||0.0000
71002333|NCT01256918|141512644|SUPERIORITY_OR_OTHER||pearson correlation coefficient|0.111166|||>|0.05|||||||pearson correlation coefficient|||null hypothesis there is no correlation between lens thickness and penetration of phacotip (phacodepth)required to achieve full thickness crack in vertical chop during phacoemulsification||||>0.05
71100855|NCT02732145|141709691|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with impaired vulvar skin and positive AWR.||||0.0000
71100856|NCT02732145|141709691|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with impaired vulvar skin and positive AWR?||||||0.4505|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with impaired vulvar skin and positive AWR.||||0.4505
71100857|NCT02732145|141709691|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Interlabial Sulci versus Posterior Commissure in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Interlabial Sulci versus Posterior Commissure in patients with impaired vulvar skin and positive AWR.||||0.0000
71100858|NCT02732145|141709691|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with impaired vulvar skin and positive AWR.||||0.0000
71100859|NCT02732145|141709691|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with normal vulva and positive AWR?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with normal vulva and positive AWR.||||1.0000
71002334|NCT03209362|141512691|SUPERIORITY||Least Squares Mean Difference|-2.9||||0.5453|TWO_SIDED|95.0|-12.4|6.6|||ANCOVA|||||6.6|-12.4|0.5453
71002335|NCT03209362|141512692|SUPERIORITY||Least Squares Mean Difference|-3.5||||0.5386|TWO_SIDED|95.0|-14.9|7.8|||Longitudinal model|||Week 12||7.8|-14.9|0.5386
71002336|NCT03209362|141512692|SUPERIORITY||Least Squares Mean Difference|-3.3||||0.5873|TWO_SIDED|95.0|-15.2|8.6|||Longitudinal model|||Week 26||8.6|-15.2|0.5873
71002337|NCT03209362|141512693|SUPERIORITY||Least Squares Mean Difference|-2.9||||0.6347|TWO_SIDED|95.0|-15.0|9.2|||Longitudinal model|||Week 12||9.2|-15.0|0.6347
71002338|NCT03209362|141512693|SUPERIORITY||Least Squares Mean Difference|-1.8||||0.7806|TWO_SIDED|95.0|-14.3|10.8|||Longitudinal model|||Week 26||10.8|-14.3|0.7806
71002339|NCT03209362|141512694|SUPERIORITY||Least Squares Mean Difference|-0.9||||0.8819|TWO_SIDED|95.0|-13.2|11.4|||Longitudinal model|||Week 12||11.4|-13.2|0.8819
71002340|NCT03209362|141512694|SUPERIORITY||Least Squares Mean Difference|-5.6||||0.3796|TWO_SIDED|95.0|-18.3|7.1|||Longitudinal model|||Week 26||7.1|-18.3|0.3796
71002341|NCT03209362|141512695|SUPERIORITY||Least Squares Mean Difference|-3.0||||0.6217|TWO_SIDED|95.0|-14.9|9.0|||Longitudinal model|||Week 12||9.0|-14.9|0.6217
71002342|NCT03209362|141512695|SUPERIORITY||Least Squares Mean Difference|-2.5||||0.6901|TWO_SIDED|95.0|-14.8|9.8|||Longitudinal model|||Week 26||9.8|-14.8|0.6901
71002343|NCT01594749|141512696|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value based on Cochran-Mantel-Haenszel (CMH) method with stratification of gender|Cochran-Mantel-Haenszel|||Percentage difference in Fosaprepitant Regimen vs. Control Regimen||||<0.001
71002344|NCT01594749|141512697|SUPERIORITY_OR_OTHER||Difference in percentage vs. Control|0.6||||0.085|TWO_SIDED|95.0|-0.2|1.7||P-value based on Miettinen \& Nurminen method|Miettinen & Nurminen method|||||1.7|-0.2|0.085
71002345|NCT01594749|141512699|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value based on CMH method with stratification of gender|Cochran-Mantel-Haenszel|||Percentage difference in Fosaprepitant Regimen vs. Control Regimen||||<0.001
71002346|NCT01594749|141512700|SUPERIORITY_OR_OTHER|||||||0.184||||||P-value based on CMH method with stratification of gender|Cochran-Mantel-Haenszel|||Percentage difference in Fosaprepitant Regimen vs. Control Regimen||||0.184
71002347|NCT01594749|141512701|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value based on CMH method with stratification of gender|Cochran-Mantel-Haenszel|||Percentage difference in Fosaprepitant Regimen vs. Control Regimen||||<0.001
71002348|NCT02177786|141512702|SUPERIORITY||Least Square Means Difference|0.38|STANDARD_ERROR_OF_MEAN|1.21||0.755|TWO_SIDED|95.0|-2.0|2.75||Data was calculated using a mixed-effect model repeated measures (MMRM) model including terms for treatment group, baseline eGFR, visit and treatment by visit interaction for comparison of change from baseline in eGFR between selonsertib and placebo.|MMRM|||||2.75|-2.00|0.755
71002349|NCT02177786|141512702|SUPERIORITY||Least Square Means Difference|0.84|STANDARD_ERROR_OF_MEAN|1.22||0.492|TWO_SIDED|95.0|-1.55|3.23||Data was calculated using a MMRM model including terms for treatment group, baseline eGFR, visit and treatment by visit interaction for comparison of change from baseline in eGFR between selonsertib and placebo.|MMRM|||||3.23|-1.55|0.492
71002350|NCT02177786|141512702|SUPERIORITY||Least Square Means Difference|-0.87|STANDARD_ERROR_OF_MEAN|1.23||0.481|TWO_SIDED|95.0|-3.29|1.56||Data was calculated using a MMRM model including terms for treatment group, baseline eGFR, visit and treatment by visit interaction for comparison of change from baseline in eGFR between selonsertib and placebo.|MMRM|||||1.56|-3.29|0.481
71002351|NCT02177786|141512703|SUPERIORITY||Difference in Percentages|-2.2||||0.798|TWO_SIDED|95.0|-16.1|11.7|||Cochran-Mantel-Haenszel|P-value was based on a Cochran-Mantel-Haenszel (CMH) test stratified by stage of disease to compare the response rate between selonsertib and placebo.|The 95% confidence interval (CI) in the difference in percentages between selonsertib and placebo was based on Wald Asymptotic test.|||11.7|-16.1|0.798
71002352|NCT02177786|141512703|SUPERIORITY||Difference in Percentages|-9.2||||0.175|TWO_SIDED|95.0|-22.3|4.0|||Cochran-Mantel-Haenszel|P-value was based on a CMH test stratified by stage of disease to compare the response rate between selonsertib and placebo.|The 95% CI in the difference in percentages between selonsertib and placebo was based on Wald Asymptotic test.|||4.0|-22.3|0.175
71002353|NCT02177786|141512703|SUPERIORITY||Difference in Percentages|-2.9||||0.686|TWO_SIDED|95.0|-16.6|10.9|||Cochran-Mantel-Haenszel|P-value was based on a CMH test stratified by stage of disease to compare the response rate between selonsertib and placebo.|The 95% CI in the difference in percentages between selonsertib and placebo was based on Wald Asymptotic test.|||10.9|-16.6|0.686
71002354|NCT00439309|141512704|NON_INFERIORITY_OR_EQUIVALENCE|The sealing success rates for the investigational group and control groups were assumed to be 0.85 (85%) and 0.75 (75%), respectively, and the non-inferiority margin (10%) is 0.10. For safety reasons it was desired to have at least 100 Vascular Sealant treated subjects. It was determined that a sample size of at least 31 evaluable subjects is required for the control group. For blocking purposes, the number of evaluable control group subjects was set to 33, for a 3:1 randomization.||||||0.072|||||||Z-Test|one-sided Z-test based on the normal approximation to the binomial distribution testing||The effectiveness analyses were performed on the ITT population.||||0.072
71002355|NCT00439309|141512705|SUPERIORITY_OR_OTHER|||||||0.006|||||||t-test, 2 sided|p-value for superiority of the Vascular Sealant System compared to the GELFOAM Treatment from two-sided test based on the GEE regression model.||||||0.006
71002356|NCT00439309|141512706|SUPERIORITY_OR_OTHER|||||||0.654|||||||t-test, 2 sided|p-value for superiority of the Vascular Sealant System compared to the GELFOAMTreatment from two-sided test based on the GEE regression model||||||0.654
71002357|NCT00439309|141512707|SUPERIORITY_OR_OTHER|||||||0.089|||||||t-test, 2 sided|||||||0.089
71100860|NCT02732145|141709691|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with normal vulva and positive AWR?||||||0.0534|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with normal vulva and positive AWR.||||0.0534
71002358|NCT00439309|141512708|SUPERIORITY_OR_OTHER|||||||0.404|||||||Log Rank|Kaplan-Meier method was used to obtain estimated median times to wound closure and the corresponding 95% confidence intervals for each treatment group||||||0.404
71002359|NCT03180294|141512715|SUPERIORITY|||||||0.46|||||||t-test, 1 sided|||Using a two sample t-test with a one-sided type I error of 0.05 (overall type I error of 0.1 after a Bonferroni correction) and an effect size of 0.45, 62 patients/arm were calculated to be needed to achieve 80% statistical power. Adjusting for 20% non-compliance resulted in a total sample size of 234 patients..||||0.46
71002360|NCT03180294|141512715|SUPERIORITY|||||||0.54|||||||t-test, 1 sided|||Using a two sample t-test with a one-sided type I error of 0.05 (overall type I error of 0.1 after a Bonferroni correction) and an effect size of 0.45, 62 patients/arm were calculated to be needed to achieve 80% statistical power. Adjusting for 20% non-compliance resulted in a total sample size of 234 patients..||||0.54
71002361|NCT03180294|141512716|SUPERIORITY|||||||0.95||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.95
71002362|NCT03180294|141512716|SUPERIORITY|||||||0.73||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.73
71002363|NCT03180294|141512716|SUPERIORITY|||||||0.46||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.46
71002364|NCT03180294|141512716|SUPERIORITY|||||||0.42||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.42
71002365|NCT03180294|141512717|SUPERIORITY|||||||0.24||||||One-side significance level 0.05|t-test, 1 sided|||||||0.24
71002366|NCT03180294|141512717|SUPERIORITY|||||||0.74||||||One-sided significance level 0.05|t-test, 1 sided|||||||0.74
71002367|NCT03180294|141512718|SUPERIORITY|||||||0.41||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.41
71002368|NCT03180294|141512718|SUPERIORITY|||||||0.6||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.60
71002369|NCT03180294|141512718|SUPERIORITY|||||||0.9||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.90
71002370|NCT03180294|141512718|SUPERIORITY|||||||0.79||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.79
71002371|NCT03180294|141512719|SUPERIORITY|||||||0.41||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.41
71002372|NCT03180294|141512719|SUPERIORITY|||||||0.35||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.35
71002373|NCT03180294|141512719|SUPERIORITY|||||||0.83||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.83
71002374|NCT03180294|141512719|SUPERIORITY|||||||0.79||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.79
71002375|NCT03180294|141512720|SUPERIORITY|||||||0.78||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.78
71002376|NCT03180294|141512720|SUPERIORITY|||||||0.51||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.51
71002377|NCT03180294|141512720|SUPERIORITY|||||||0.49||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.49
71002378|NCT03180294|141512720|SUPERIORITY|||||||0.5||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.50
71002379|NCT03180294|141512721|SUPERIORITY|||||||0.71|||||||Chi-squared|One-sided significance level 0.05||||||0.71
71002380|NCT03180294|141512721|SUPERIORITY|||||||0.34|||||||Chi-squared|One-sided significance level 0.05||||||0.34
71002381|NCT03180294|141512722|SUPERIORITY|||||||0.23||||||One-sided significance level 0.05|t-test, 1 sided|||||||0.23
71002382|NCT03180294|141512722|SUPERIORITY|||||||0.25||||||One-sided significance level 0.05|t-test, 1 sided|||||||0.25
71002383|NCT02527564|141512734|OTHER|||||||0.1||||||A p-value of \<0.05 would be considered statistically significant.|Paired 2-sided t-test|||Within group change at week 1 - suvorexant (double-blind)||||0.10
71002384|NCT02527564|141512734|OTHER|||||||0.57||||||A p-value of \<0.05 would be considered statistically significant.|Paired 2-sided t-test|||Within group change at week 1- placebo (double-blind) group||||0.57
71002385|NCT02527564|141512734|OTHER|||||||0.44||||||A p-value of \<0.05 would be considered statistically significant.|Unpaired 2-sided t-test|||Between group change at week 1||||0.44
71002386|NCT02527564|141512735|OTHER|||||||0.035||||||A p-value of \<0.05 would be considered significantly significant.|Paired 2-sided t-test|||Within group change at week 1 - suvorexant (double-blind)||||0.035
71002387|NCT02527564|141512735|OTHER|||||||0.55|||||||Paired 2-sided t-test|A p-value of \<0.05 would be considered statistically significant.||Within group change at week 1- placebo (double-blind) group||||0.55
71002388|NCT02527564|141512735|OTHER|||||||0.89||||||A p-value of \<0.05 would be considered statistically significant.|Paired 2-sided t-test|||Between group change at week 1||||0.89
71002389|NCT02527564|141512736|OTHER|||||||0.97||||||A p-value of \<0.05 would be considered significantly significant.|Paired 2-sided t-test|||Within group change at month 3 - suvorexant (open-label)||||0.97
71002390|NCT02527564|141512737|OTHER|||||||0.28||||||A p-value of \<0.05 would be considered significantly significant.|Paired 2-sided t-test|||Within group change at month 3 - suvorexant (open-label)||||0.28
71002391|NCT00420342|141512738|SUPERIORITY_OR_OTHER|||||||0.1182||95.0||||0.5 mg DRSP / 1.0 mg E2 vs 1.5 mg MPA / 0.3 mg CEE.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.||||0.1182
71002392|NCT00420342|141512738|SUPERIORITY_OR_OTHER|||||||0.2224||95.0||||2.0 mg DRSP / 1.0 mg E2 vs 1.5mg MPA / 0.3 mg CEE.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.||||0.2224
71002393|NCT00420342|141512738|SUPERIORITY_OR_OTHER|||||||0.6929||95.0||||0.5 mg DRSP / 1.0 mg E2 vs 2.0 mg DRSP / 1.0 mg E2.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.||||0.6929
71002394|NCT00420342|141512739|SUPERIORITY_OR_OTHER|||||||0.0702||95.0||||0.5 mg DRSP / 1.0 mg E2 vs 1.5 mg MPA / 0.3 mg CEE.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.||||0.0702
71002395|NCT00420342|141512739|SUPERIORITY_OR_OTHER|||||||0.198||95.0||||2.0 mg DRSP / 1.0 mg E2 vs 1.5mg MPA / 0.3 mg CEE.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.||||0.1980
71002396|NCT00420342|141512739|SUPERIORITY_OR_OTHER|||||||0.5777||95.0||||0.5 mg DRSP / 1.0 mg E2 vs 2.0 mg DRSP / 1.0 mg E2.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.||||0.5777
71002397|NCT02473289|141512757|SUPERIORITY||Difference of Least Square (LS) Means|-0.8|STANDARD_ERROR_OF_MEAN|1.67||0.31|TWO_SIDED|75.0|-2.77|1.1||1-sided|MMRM|Here 'MMRM' refers to Mixed-effect Model Using Repeated Measures.||||1.10|-2.77|0.310
71042952|NCT01844531|141594594|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|97.21|STANDARD_ERROR_OF_MEAN|15.1||0.0004|TWO_SIDED|90.0|89.41|105.68|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa12.5 (T1) : Empa12.5 + Met500 (R1), PK set AUCinfpred \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||105.68|89.41|0.0004
71042953|NCT01844531|141594594|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|96.79|STANDARD_ERROR_OF_MEAN|9.8||0|TWO_SIDED|90.0|91.772|102.093|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500, PK set AUCinfpred \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||102.093|91.772|0.0000
71002398|NCT01291511|141512779|SUPERIORITY||Cox Proportional Hazard|5.2|||<|0.0001|TWO_SIDED|95.0|3.2|8.4|||Log Rank|||||8.4|3.2|<0.0001
71002399|NCT01291511|141512780|SUPERIORITY||||||<|0.0001||||||P-value is based on an ANCOVA model with treatment and site as main effects and DBRP baseline as a covariate.|ANCOVA|||||||<0.0001
71002400|NCT01291511|141512782|SUPERIORITY|||||||0.0062||||||P-value is based on an ANCOVA model with treatment and site as main effects and DBRP baseline as a covariate.|ANCOVA|||||||0.0062
71002401|NCT00047008|141512787|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.18|TWO_SIDED|95.0|0.719|1.128|||Log Rank|||A sample size of 684 analyzable patients provides 80% power to detect a relative reduction of 25% in the rate of death in the accelerated-fractionation radiotherapy group as compared with the standard-fractionation radiotherapy group, assuming a 2-year rate of overall survival of 45% in the standard-fractionation radiotherapy group, with the use of a one-sided log-rank test at the 0.05 significance level.||1.128|0.719|0.180
71002402|NCT00047008|141512788|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.76|TWO_SIDED|95.0|0.83|1.43||One-sided significance level = 0.05|Gray's test|||||1.43|0.83|0.76
71002403|NCT00047008|141512789|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.8|TWO_SIDED|95.0|0.85|1.44||One-sided significance level = 0.05|Gray's test|||||1.44|0.85|0.80
71002404|NCT00047008|141512790|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.42|TWO_SIDED|95.0|0.81|1.2||One-sided significance level = 0.05|Log Rank|||||1.20|0.81|0.42
71002405|NCT00047008|141512791|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.5|TWO_SIDED|95.0|0.81|1.23||One-sided significance level = 0.05|Log Rank|||||1.23|0.81|0.50
71002406|NCT00047008|141512792|SUPERIORITY|||||||0.21||||||Two-side significance level = 0.05|Fisher Exact|||Acute toxicity||||0.21
71002407|NCT00047008|141512792|SUPERIORITY|||||||0.18||||||Two-sided significance level = 0.05|Fisher Exact|||Late toxicity||||0.18
71002408|NCT00047008|141512793|SUPERIORITY|||||||0.92||||||Two-sided significance level = 0.05|t-test, 2 sided|||Two hundred and fifty-two patients (126/arm) provide at least 86% power to detect a difference of 7 (standard deviation 18) between arms with a two-sided significance level of 0.05.||||0.92
71002409|NCT00047008|141512794|SUPERIORITY|||||||0.67||||||Two-sided significance level = 0.05|t-test, 2 sided|||Two hundred and fifty-two patients (126/arm) provide at least 86% power to detect a difference of 7 (standard deviation 18) between arms with a two-sided significance level of 0.05.||||0.67
71002410|NCT00047008|141512795|SUPERIORITY|||||||0.43||||||Two-sided significance level = 0.05|t-test, 2 sided|||Two hundred and fifty-two patients (126/arm) provide at least 86% power to detect a difference of 7 (standard deviation 18) between arms with a two-sided significance level of 0.05.||||0.43
71002411|NCT00047008|141512796|SUPERIORITY|||||||0.39||||||Two-sided significance level = 0.05|t-test, 2 sided|||Two hundred and fifty-two patients (126/arm) provide at least 86% power to detect a difference of 7 (standard deviation 18) between arms with a two-sided significance level of 0.05.||||0.39
71002412|NCT00796003|141512816|SUPERIORITY_OR_OTHER||Overall Response Rate|26.5|STANDARD_ERROR_OF_MEAN|7.6|<|0.0001|TWO_SIDED|90.0|14.6|41.6|||Binomial test|one-tailed 5% level at a significance level||Null Hypothesis: Overall Remission Rate = 5%||41.6|14.6|<0.0001
71002413|NCT05179057|141512827|SUPERIORITY|A logistic regression model included treatment, level of viremia at baseline (≥10,000 copies/mL or \<10,000 copies/mL adenovirus DNA), age (≥12 years or \<12 years), and absolute lymphocyte counts at baseline. The null hypothesis is that the true percentage for posoleucel plus SoC is less than or equal to the true percentage for placebo plus SoC, and the alternative hypothesis is that it is greater.|Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.26|3.69|||||Posoleucel versus Placebo|||3.69|0.26|
71002414|NCT02437162|141512834|SUPERIORITY||Percentage difference|2.586||||0.669|TWO_SIDED|95.0|-9.138|14.31|||Cochran-Mantel-Haenszel|||||14.310|-9.138|0.669
71002415|NCT02437162|141512834|SUPERIORITY||Percentage difference|-0.646||||0.913|TWO_SIDED|95.0|-12.18|10.887|||Cochran-Mantel-Haenszel|||||10.887|-12.180|0.913
71002416|NCT04338321|141512870|SUPERIORITY||Mean Difference (Final Values)|9.44|||=|0.003|TWO_SIDED|95.0|3.19|15.68|||Cochran-Mantel-Haenszel|||||15.68|3.19|=0.003
71002417|NCT03107793|141512895|SUPERIORITY||||||=|0.0871|||||||Cochran-Mantel-Haenszel|||||||= 0.0871
71002418|NCT02808507|141512919|OTHER||Treatment initiation ratio|1.04||||0.73|TWO_SIDED|95.0|0.8|1.3|||See above comments|||The primary analysis was based on the facility-level rate ratio. We first calculated an unadjusted ratio of the treatment initiation rates between the two arms and the corresponding 95% CI. We first fit a Poisson regression to the facility-level counts and the district and historical volume covariates. The residuals ratios, calculated as the ratio of the observed over the expected counts, were then used in the second stage to estimate the between-arm rate ratio and the corresponding 95% CI.||1.3|0.80|0.73
71002419|NCT02808507|141512920|OTHER||Treatment initiation ratio|1.05||||0.68|TWO_SIDED|95.0|0.97|1.13|||Poisson regression||Adjusted for district, study phase and clinic random effect.|The primary outcome of the study was the comparative number of people with incident TB diagnosed and started on treatment at study clinics during the two study periods, excluding the six-month washout period. The number of people starting treatment for incident TB was calculated by performing a review of paper and electronic medical records at each clinic on a quarterly basis during the study.||1.13|0.97|0.68
71002420|NCT02808507|141512921|OTHER||Prevalence ratio|1.0||||0.8|TWO_SIDED|95.0|0.51|1.95||"The pre-specified secondary study outcome was the number of Xpert-based TB diagnoses made among enrolled contacts (secondary cases) by arm."|Poisson regression||Adjusted for study phase and district|||1.95|0.51|0.80
71002421|NCT01989572|141512926|SUPERIORITY_OR_OTHER_LEGACY|||||||0.528|||||||Log Rank|stratifying on HLA-A2 status, site of metastases and number of metastatic lesions.||||||0.528
71002422|NCT01989572|141512927|SUPERIORITY_OR_OTHER_LEGACY|||||||0.131|||||||Log Rank|stratifying on HLA-A2 status, site of metastases, and number of metastatic lesions||||||0.131
71002423|NCT01989572|141512928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|||||||Log Rank|stratifying on GM-CSF, site of metastases and number of metastatic lesions||||||0.60
71002424|NCT01989572|141512929|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71||||||stratifying on GM-CSF, site of metastases and number of metastatic lesions|Log Rank|||||||0.71
71002425|NCT01989572|141512930|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88|||||||Log Rank|stratifying on site of metastases and number of metastatic lesions||Treatment arm comparison in patients with positive HLA-A2 status||||0.88
71002426|NCT01989572|141512930|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69|||||||Log Rank|stratifying on site of metastases and number of metastatic lesions||Treatment arm comparison in patients with negative HLA-A2 status||||0.69
71002427|NCT01989572|141512931|SUPERIORITY_OR_OTHER_LEGACY|||||||0.91|||||||Log Rank|stratifying on site of metastases and number of metastatic lesions||Treatment arm comparison in patients with positive HLA-A2 status||||0.91
70924484|NCT03498651|141341399|SUPERIORITY||Mean Difference (Net)|-0.55|STANDARD_DEVIATION|0.02|||TWO_SIDED|95.0|-0.6|-0.51|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% bootstrap confidence interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation)."||-0.51|-0.60|
71002428|NCT01989572|141512931|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|||||||Log Rank|stratifying on site of metastases and number of metastatic lesions||Treatment arm comparisons in patients with negative HLA-A2 status||||0.13
71002429|NCT01024920|141512941|OTHER|||||||0.8531||||||P-value for comparison of Kaplan-Meier estimates at 9 months using normal approximation test (two-sided).|Normal approximation test|||||||0.8531
71002430|NCT01024920|141512943|OTHER||Hazard Ratio (HR)|1.12||||0.6395|TWO_SIDED|95.0|0.697|1.8|||Log Rank||Hazard ratio from Cox proportional hazards model stratified by Motzer risk score and previous surgery.|A stratified log-rank test (two-sided, 0.05 significance level) was used to test the effect of nintedanib on PFS compared with sunitinib. The test was stratified by Motzer risk score category (low/intermediate or high) and prior nephrectomy surgery for Renal Cell Cancer (yes or no).||1.800|0.697|0.6395
71002431|NCT01024920|141512944|OTHER||Odds Ratio (OR)|0.484||||0.1213|TWO_SIDED|95.0|0.193|1.212|||Regression, Logistic||Odds ratio \> 1 favours nintedanib.|A logistic regression model stratified by Motzer risk score category and prior surgery for renal cell cancer (RCC) was used to compare the objective response rate between the two treatment arms. The corresponding odds ratio and 95% Confidence Intervals was also presented.||1.212|0.193|0.1213
71002432|NCT01024920|141512946|OTHER||Hazard Ratio (HR)|0.92||||0.7593|TWO_SIDED|95.0|0.542|1.564||P-value from log-rank stratified by Motzer risk score and previous surgery.|Log Rank||Hazard ratio from Cox proportional hazards model stratified by Motzer risk score and previous surgery. Hazard ratio \< 1 favours nintedanib.|||1.564|0.542|0.7593
71002433|NCT01024920|141512947|OTHER||Cox Proportional Hazard|1.143||||0.5958|TWO_SIDED|95.0|0.697|1.873|||Log Rank|P-value from log-rank stratified by Motzer risk score and previous surgery.|Hazard ratio from Cox proportional hazards model stratified by Motzer risk score and previous surgery. Hazard ratio \< 1 favours nintedanib.|||1.873|0.697|0.5958
71002434|NCT01024920|141512948|OTHER||Hazard Ratio (HR)|1.142||||0.5712|TWO_SIDED|95.0|0.72|1.812|||Log Rank|P-value from log-rank stratified by Motzer risk score and previous surgery (two-sided).|Hazard ratio from Cox proportional hazards model stratified by Motzer risk score and previous surgery. Hazard ratio \< 1 favours nintedanib.|||1.812|0.720|0.5712
71042954|NCT01844531|141594594|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|96.91|STANDARD_ERROR_OF_MEAN|9.8|<|0.0001|TWO_SIDED|90.0|91.79|102.32|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa5 : Empa5 + Met500, PK set AUCinfpred \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||102.32|91.79|<.0001
71042955|NCT01844531|141594595|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|98.0|STANDARD_ERROR_OF_MEAN|8.5||0|TWO_SIDED|90.0|93.53|102.686|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUClast \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||102.686|93.530|0.0000
70924485|NCT03498651|141341399|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_DEVIATION|0.13|||TWO_SIDED|95.0|-0.23|0.27|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% HPD credible interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach)."||0.27|-0.23|
71002435|NCT02977507|141512984|OTHER|||||||0.041|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.041
71002436|NCT02977507|141512984|OTHER|||||||0.0005|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.0005
71002437|NCT02977507|141512985|OTHER|||||||0.002|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.002
71002438|NCT02977507|141512985|OTHER|||||||0.0001|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.0001
71002439|NCT02977507|141512986|OTHER|||||||0.004|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.004
71002440|NCT02977507|141512986|OTHER|||||||0.001|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.001
71002441|NCT02977507|141512990|OTHER|||||||0.003|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.003
71002442|NCT02977507|141512990|OTHER|||||||0.0007|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.0007
71002443|NCT02977507|141512992|OTHER|||||||0.569|||||||Paired t-test|||Melanin index: Testing hypothesis is that the mean change from baseline is zero.||||0.569
71002444|NCT02977507|141512992|OTHER|||||||9e-05|||||||Paired t-test|||Melanin index: Testing hypothesis is that the mean change from baseline is zero.||||0.00009
71002445|NCT02977507|141512992|OTHER|||||||0.821|||||||Paired t-test|||Erythema: Testing hypothesis is that the mean change from baseline is zero.||||0.821
71002446|NCT02977507|141512992|OTHER|||||||0.502|||||||Paired t-test|||Erythema: Testing hypothesis is that the mean change from baseline is zero.||||0.502
71002447|NCT02977507|141512992|OTHER|||||||0.81|||||||Paired t-test|||Melanin index: Testing hypothesis is that the mean change from baseline is zero.||||0.810
71042956|NCT01844531|141594595|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|98.07|STANDARD_ERROR_OF_MEAN|8.5|<|0.0001|TWO_SIDED|90.0|93.55|102.81|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUClast \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||102.81|93.55|<.0001
71042957|NCT01844531|141594595|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|102.77|STANDARD_ERROR_OF_MEAN|6.5||0|TWO_SIDED|90.0|99.146|106.522|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500, PK set AUClast \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||106.522|99.146|0.0000
71002448|NCT02977507|141512992|OTHER|||||||0.435|||||||Paired t-test|||Erythema: Testing hypothesis is that the mean change from baseline is zero.||||0.435
71002449|NCT00633360|141512993|SUPERIORITY_OR_OTHER|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||||||.59
71002450|NCT00633360|141512994|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||||||.29
71002451|NCT00565812|141513056|SUPERIORITY_OR_OTHER||Difference in Slopes|0.012|STANDARD_ERROR_OF_MEAN|0.018||0.50877|TWO_SIDED|95.0|-0.023|0.046|||Mixed Models Analysis|||Slopes, 95 percent confidence interval (CI), P-values: Random coefficients mixed-effects model for repeated measures (MMRM) with random intercept and slope for each participant,fixed effects for treatment group,time (years),treatment group\*time interaction,(collapsed)Kellgren and Lawrence Grades (KLG), KLG\*time interaction,geographic region,gender,age,body mass index with unstructured covariance matrix for random effects. Statistical hypothesis used Hochberg procedure with 2-sided alpha =0.0499.||0.046|-0.023|0.508770
71002452|NCT00565812|141513056|SUPERIORITY_OR_OTHER||Difference in Slopes|0.005|STANDARD_ERROR_OF_MEAN|0.017||0.754074|TWO_SIDED|95.0|-0.029|0.04|||Mixed Models Analysis|||Slopes, 95 percent CI, P-values: MMRM with random intercept and slope for each participant, fixed effects for treatment group, time (years), treatment group\*time interaction, (collapsed) KLG, KLG\*time interaction, geographic region, gender, age, body mass index with unstructured covariance matrix for random effects. Statistical hypothesis used Hochberg procedure with 2-sided alpha=0.0499.||0.040|-0.029|0.754074
71042958|NCT01844531|141594595|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|102.49|STANDARD_ERROR_OF_MEAN|6.5|<|0.0001|TWO_SIDED|90.0|98.85|106.25|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa5 : Empa5 + Met500, PK set AUClast \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||106.25|98.85|<.0001
71002453|NCT00565812|141513057|SUPERIORITY_OR_OTHER||Difference in slopes|0.023|STANDARD_ERROR_OF_MEAN|0.023||0.312|TWO_SIDED|95.0|-0.022|0.067|||Mixed Models Analysis|||Slopes, 95 percent CI and P-values were obtained from a random coefficients MMRM with random intercept and slope for each participant, and fixed effects for treatment group, time (years), a treatment group\*time (years) interaction, geographic region, gender, age, and body mass index with an unstructured covariance matrix for the random effects.||0.067|-0.022|0.312
71002454|NCT00565812|141513057|SUPERIORITY_OR_OTHER||Difference in slopes|0.022|STANDARD_ERROR_OF_MEAN|0.023||0.327|TWO_SIDED|95.0|-0.022|0.067|||Mixed Models Analysis|||Slopes, 95 percent CI and P-values were obtained from a random coefficients MMRM with random intercept and slope for each participant, and fixed effects for treatment group, time (years), a treatment group\*time (years) interaction, geographic region, gender, age, and body mass index with an unstructured covariance matrix for the random effects.||0.067|-0.022|0.327
71042959|NCT01844531|141594596|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|104.61|STANDARD_ERROR_OF_MEAN|8.4||0|TWO_SIDED|90.0|99.882|109.555|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set Cmax \[nmol/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||109.555|99.882|0.0000
71002455|NCT00565812|141513058|SUPERIORITY_OR_OTHER||Difference in slopes|0.004|STANDARD_ERROR_OF_MEAN|0.026||0.881|TWO_SIDED|95.0|-0.046|0.054|||Mixed Models Analysis|||Slopes, 95 percent CI and P-values were obtained from a random coefficients MMRM with random intercept and slope for each participant, and fixed effects for treatment group, time (years), a treatment group\*time (years) interaction, geographic region, gender, age, and body mass index with an unstructured covariance matrix for the random effects.||0.054|-0.046|0.881
71002456|NCT00565812|141513058|SUPERIORITY_OR_OTHER||Difference in slopes|-0.007|STANDARD_ERROR_OF_MEAN|0.025||0.78|TWO_SIDED|95.0|-0.056|0.042|||Mixed Models Analysis|||Slopes, 95 percent CI and P-values were obtained from a random coefficients MMRM with random intercept and slope for each participant, and fixed effects for treatment group, time (years), a treatment group\*time (years) interaction, geographic region, gender, age, and body mass index with an unstructured covariance matrix for the random effects.||0.042|-0.056|0.780
71002457|NCT00565812|141513059|SUPERIORITY_OR_OTHER||LS mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.84||0.639|TWO_SIDED|95.0|-1.26|2.05|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.05|-1.26|0.639
71002458|NCT00565812|141513059|SUPERIORITY_OR_OTHER||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.84||0.957|TWO_SIDED|95.0|-1.61|1.7|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.70|-1.61|0.957
71002459|NCT00565812|141513059|SUPERIORITY_OR_OTHER||LS mean difference|0.13|STANDARD_ERROR_OF_MEAN|0.96||0.893|TWO_SIDED|95.0|-1.76|2.01|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.01|-1.76|0.893
71002460|NCT00565812|141513059|SUPERIORITY_OR_OTHER||LS mean difference|0.87|STANDARD_ERROR_OF_MEAN|0.96||0.365|TWO_SIDED|95.0|-1.01|2.76|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.76|-1.01|0.365
71002461|NCT00565812|141513059|SUPERIORITY_OR_OTHER||LS mean difference|0.44|STANDARD_ERROR_OF_MEAN|1.05||0.678|TWO_SIDED|95.0|-1.63|2.51|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.51|-1.63|0.678
71042960|NCT01844531|141594596|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|104.53|STANDARD_ERROR_OF_MEAN|8.4|<|0.0001|TWO_SIDED|90.0|99.76|109.53|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa12.5 : Empa12.5 + Met500, PK set Cmax \[nmol/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||109.53|99.76|<.0001
71002462|NCT00565812|141513059|SUPERIORITY_OR_OTHER||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|1.05||0.902|TWO_SIDED|95.0|-2.18|1.93|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.93|-2.18|0.902
71002463|NCT00565812|141513059|SUPERIORITY_OR_OTHER||LS mean difference|-0.64|STANDARD_ERROR_OF_MEAN|1.15||0.577|TWO_SIDED|95.0|-2.89|1.61|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.61|-2.89|0.577
71002464|NCT00565812|141513059|SUPERIORITY_OR_OTHER||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|1.14||0.98|TWO_SIDED|95.0|-2.26|2.21|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.21|-2.26|0.980
71042961|NCT01844531|141594596|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|102.96|STANDARD_ERROR_OF_MEAN|9.2||0|TWO_SIDED|90.0|97.917|108.258|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500, PK set Cmax \[nmol/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||108.258|97.917|0.0000
71002465|NCT00565812|141513059|SUPERIORITY_OR_OTHER||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|1.17||0.95|TWO_SIDED|95.0|-2.37|2.23|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.23|-2.37|0.950
71002466|NCT00565812|141513059|SUPERIORITY_OR_OTHER||LS mean difference|-1.23|STANDARD_ERROR_OF_MEAN|1.17||0.292|TWO_SIDED|95.0|-3.53|1.06|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.06|-3.53|0.292
71002467|NCT00565812|141513060|SUPERIORITY_OR_OTHER||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.19||0.683|TWO_SIDED|95.0|-0.3|0.46|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\* visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.46|-0.30|0.683
71002468|NCT00565812|141513060|SUPERIORITY_OR_OTHER||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.19||0.853|TWO_SIDED|95.0|-0.42|0.35|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.35|-0.42|0.853
71002469|NCT00565812|141513060|SUPERIORITY_OR_OTHER||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.22||0.938|TWO_SIDED|95.0|-0.41|0.44|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\* visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.44|-0.41|0.938
71002470|NCT00565812|141513060|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.22||0.648|TWO_SIDED|95.0|-0.32|0.52|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.52|-0.32|0.648
71002471|NCT00565812|141513060|SUPERIORITY_OR_OTHER||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.24||0.916|TWO_SIDED|95.0|-0.49|0.44|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.44|-0.49|0.916
71002472|NCT00565812|141513060|SUPERIORITY_OR_OTHER||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.23||0.528|TWO_SIDED|95.0|-0.6|0.31|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.31|-0.60|0.528
71002473|NCT00565812|141513060|SUPERIORITY_OR_OTHER||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.25||0.365|TWO_SIDED|95.0|-0.73|0.27|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.27|-0.73|0.365
71042962|NCT01844531|141594596|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|102.8|STANDARD_ERROR_OF_MEAN|9.2|<|0.0001|TWO_SIDED|90.0|97.72|108.14|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa5 : Empa5 + Met500, PK set Cmax \[nmol/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||108.14|97.72|<.0001
71100861|NCT02732145|141709691|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with normal vulva and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with normal vulva and positive AWR.||||0.0000
71100862|NCT02732145|141709691|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with normal vulva and positive AWR?||||||0.0534|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with normal vulva and positive AWR.||||0.0534
71042963|NCT01844531|141594597|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|94.76|STANDARD_ERROR_OF_MEAN|11.4||0.0001|TWO_SIDED|90.0|89.056|100.819|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set Cmax \[ng/mL\] for METFORMIN (PLASMA EDTA)||100.819|89.056|0.0001
71100863|NCT02732145|141709691|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci versus Posterior Commissure in patients with normal vulva and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci versus Posterior Commissure in patients with normal vulva and positive AWR.||||0.0000
71100864|NCT02732145|141709691|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with normal vulva and positive AWR?||||||0.0005|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with normal vulva and positive AWR.||||0.0005
71100865|NCT02732145|141709692|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris among patients from different groups, with positive AWR.||||0.0000
70924486|NCT03498651|141341400|SUPERIORITY||Mean Difference (Net)|-0.41|STANDARD_DEVIATION|0.03|||TWO_SIDED|95.0|-0.46|-0.37|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% bootstrap confidence interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation)."||-0.37|-0.46|
70924487|NCT03498651|141341400|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.14|||TWO_SIDED|95.0|-0.23|0.32|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% HPD credible interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach)."||0.32|-0.23|
71002474|NCT00565812|141513060|SUPERIORITY_OR_OTHER||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.25||0.328|TWO_SIDED|95.0|-0.74|0.25|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.25|-0.74|0.328
71002475|NCT00565812|141513060|SUPERIORITY_OR_OTHER||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.26||0.54|TWO_SIDED|95.0|-0.66|0.35|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.35|-0.66|0.540
71002476|NCT00565812|141513060|SUPERIORITY_OR_OTHER||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.26||0.423|TWO_SIDED|95.0|-0.71|0.3|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.30|-0.71|0.423
71002477|NCT00565812|141513061|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.09||0.904|TWO_SIDED|95.0|-0.17|0.2|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.20|-0.17|0.904
71002478|NCT00565812|141513061|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.09||0.582|TWO_SIDED|95.0|-0.24|0.13|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.13|-0.24|0.582
71002479|NCT00565812|141513061|SUPERIORITY_OR_OTHER||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.1||0.818|TWO_SIDED|95.0|-0.22|0.18|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.18|-0.22|0.818
71002480|NCT00565812|141513061|SUPERIORITY_OR_OTHER||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.988|TWO_SIDED|95.0|-0.2|0.2|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group x visit interaction, (collapsed) KLG, a (collapsed) KLG x visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.20|-0.20|0.988
71002481|NCT00565812|141513061|SUPERIORITY_OR_OTHER||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.11||0.857|TWO_SIDED|95.0|-0.2|0.24|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.24|-0.20|0.857
71042964|NCT01844531|141594597|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|94.4|STANDARD_ERROR_OF_MEAN|11.4||0.0001|TWO_SIDED|90.0|88.64|100.54|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa12.5 : Empa12.5 + Met500, PK set Cmax \[ng/mL\] for METFORMIN (PLASMA EDTA)||100.54|88.64|0.0001
71042965|NCT01844531|141594597|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|93.83|STANDARD_ERROR_OF_MEAN|11.9||0.0002|TWO_SIDED|90.0|88.006|100.034|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500, PK set Cmax \[ng/mL\] for METFORMIN (PLASMA EDTA)||100.034|88.006|0.0002
71100866|NCT02732145|141709692|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line among patients from different groups, with positive AWR.||||0.0000
71100867|NCT02732145|141709692|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Sulcus among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Sulcus among patients from different groups, with positive AWR.||||0.0000
71002482|NCT00565812|141513061|SUPERIORITY_OR_OTHER||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.658|TWO_SIDED|95.0|-0.17|0.27|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.27|-0.17|0.658
71002483|NCT00565812|141513061|SUPERIORITY_OR_OTHER||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.12||0.612|TWO_SIDED|95.0|-0.28|0.17|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.17|-0.28|0.612
71002484|NCT00565812|141513061|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.391|TWO_SIDED|95.0|-0.32|0.13|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.13|-0.32|0.391
71002485|NCT00565812|141513061|SUPERIORITY_OR_OTHER||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||1|TWO_SIDED|95.0|-0.24|0.24|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.24|-0.24|1.000
71002486|NCT00565812|141513061|SUPERIORITY_OR_OTHER||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.12||0.086|TWO_SIDED|95.0|-0.45|0.03|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.03|-0.45|0.086
71042966|NCT01844531|141594597|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|93.98|STANDARD_ERROR_OF_MEAN|12.0||0.0003|TWO_SIDED|90.0|87.94|100.43|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa5 : Empa5 + Met500, PK set Cmax \[ng/mL\] for METFORMIN (PLASMA EDTA)||100.43|87.94|0.0003
71042967|NCT01844531|141594598|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|95.78|STANDARD_ERROR_OF_MEAN|15.7||0.0008|TWO_SIDED|90.0|88.0|104.256|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUClast \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||104.256|88.000|0.0008
71042968|NCT01844531|141594598|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|96.74|STANDARD_ERROR_OF_MEAN|15.5||0.0006|TWO_SIDED|90.0|88.78|105.41|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUClast \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||105.41|88.78|0.0006
71042969|NCT01844531|141594598|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|95.94|STANDARD_ERROR_OF_MEAN|9.3||0|TWO_SIDED|90.0|91.199|100.934|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500, PK set AUClast \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||100.934|91.199|0.0000
71042970|NCT01844531|141594598|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|96.1|STANDARD_ERROR_OF_MEAN|9.3|<|0.0001|TWO_SIDED|90.0|91.28|101.19|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa5 : Empa5 + Met500, PK set AUClast \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||101.19|91.28|<.0001
71100868|NCT02732145|141709692|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Meatus among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Meatus among patients from different groups, with positive AWR.||||0.0000
71100869|NCT02732145|141709692|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Hymenal Remnants among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Hymenal Remnants among patients from different groups, with positive AWR.||||0.0000
71100870|NCT02732145|141709692|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Bartholin's Gland Opening among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Bartholin's Gland Opening among patients from different groups, with positive AWR.||||0.0000
71100871|NCT02732145|141709692|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Vestibule among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Vestibule among patients from different groups, with positive AWR.||||0.0000
71100872|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hart's line in patients with vulvar dermatosis and positive AWR?||||||0.8545|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hart's line in patients with vulvar dermatosis and positive AWR.||||0.8545
71100873|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with vulvar dermatosis and positive AWR?||||||0.8569|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with vulvar dermatosis and positive AWR.||||0.8569
70924488|NCT03498651|141341401|SUPERIORITY||Mean Difference (Net)|-0.33|STANDARD_DEVIATION|0.03|||TWO_SIDED|95.0|-0.39|-0.27|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% bootstrap confidence interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation)."||-0.27|-0.39|
70924489|NCT03498651|141341401|SUPERIORITY||Mean Difference (Net)|0.17|STANDARD_DEVIATION|0.16|||TWO_SIDED|95.0|-0.14|0.48|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% HPD credible interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach)."||0.48|-0.14|
70924490|NCT04382404|141341422|OTHER||Geometric mean ratio|0.85|||||TWO_SIDED|90.0|0.63|1.15|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|Maximum concentration of Velpatasvir in plasma was compared between the 10 pregnant women in this study to 25 non-pregnant historical control women. The geometric mean concentration (percent coefficient of variation) for the non-pregnant cohort was 449.39 (77.12).||1.15|0.63|
71002487|NCT00565812|141513062|SUPERIORITY_OR_OTHER||LS mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.62||0.586|TWO_SIDED|95.0|-0.88|1.55|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.55|-0.88|0.586
71002488|NCT00565812|141513062|SUPERIORITY_OR_OTHER||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.62||0.789|TWO_SIDED|95.0|-1.05|1.38|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.38|-1.05|0.789
71002489|NCT00565812|141513062|SUPERIORITY_OR_OTHER||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.69||0.821|TWO_SIDED|95.0|-1.21|1.52|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.52|-1.21|0.821
71002490|NCT00565812|141513062|SUPERIORITY_OR_OTHER||LS mean difference|0.73|STANDARD_ERROR_OF_MEAN|0.69||0.294|TWO_SIDED|95.0|-0.63|2.09|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.09|-0.63|0.294
71002491|NCT00565812|141513062|SUPERIORITY_OR_OTHER||LS mean difference|0.48|STANDARD_ERROR_OF_MEAN|0.76||0.532|TWO_SIDED|95.0|-1.02|1.97|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.97|-1.02|0.532
71002492|NCT00565812|141513062|SUPERIORITY_OR_OTHER||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.76||0.938|TWO_SIDED|95.0|-1.55|1.43|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.43|-1.55|0.938
71002493|NCT00565812|141513062|SUPERIORITY_OR_OTHER||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.83||0.68|TWO_SIDED|95.0|-1.97|1.29|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.29|-1.97|0.680
71042971|NCT02744755|141594599|EQUIVALENCE|A 0.6 change in DAS28-CRP score is considered as no clinically meaningful difference by EULAR criteria and is therefore used as the equivalence margin limits \[0.6,-0.6\].|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.129|||TWO_SIDED|95.0|-0.24|0.27||||||Therapeutic equivalence in terms of change from baseline in DAS28-CRP at week 12 will be concluded if the 95% confidence interval for the LS mean difference between GP2017 and Humira is contained within the interval \[-0.6; 0.6\]. A mixed-model repeated measures analysis was performed for DAS28-CRP change from baseline including treatment, stratification factors, time, the interaction between time (visits) and treatment all as categorical variables, and baseline DAS28-CRP as a continuous variable.||0.27|-0.24|
71002494|NCT00565812|141513062|SUPERIORITY_OR_OTHER||LS mean difference|0.28|STANDARD_ERROR_OF_MEAN|0.82||0.73|TWO_SIDED|95.0|-1.33|1.9|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.90|-1.33|0.730
70924491|NCT04382404|141341423|OTHER||Geometric mean ratio|1.19|||||TWO_SIDED|90.0|0.88|1.6|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|Maximum concentration of Sofosbuvir in plasma was compared between the 10 pregnant women in this study to 25 non-pregnant historical control women. The geometric mean concentration (percent coefficient of variation) for the non-pregnant cohort was 1226.16 (59.46).||1.60|0.88|
70924492|NCT04382404|141341424|OTHER||Geometric mean ratio|0.57|||||TWO_SIDED|90.0|0.49|0.67|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|Maximum concentration of GS-331007 in plasma was compared between the 10 pregnant women in this study to 25 non-pregnant historical control women. The geometric mean concentration (percent coefficient of variation) for the non-pregnant cohort was 1312.17 (32.55).||0.67|0.49|
70924493|NCT04382404|141341425|OTHER||Geometric mean ratio|0.91|||||TWO_SIDED|90.0|0.67|1.23|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|Area under the plasma concentration versus time curve tau of Velpatasvir was compared between the 10 pregnant women in this study to 25 non-pregnant historical control women. The geometric mean (percent coefficient of variation) for the non-pregnant cohort was 3570.65 (72.04).||1.23|0.67|
70924494|NCT04382404|141341426|OTHER||Geometric mean ratio|1.39|||||TWO_SIDED|90.0|1.06|1.78||||||Area under the plasma concentration versus time curve tau of Sofosbuvir was compared between the 10 pregnant women in this study to 25 non-pregnant historical control women. The geometric mean (percent coefficient of variation) for the non-pregnant cohort was 1483.83 (66.43).|The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|1.78|1.06|
71002495|NCT00565812|141513062|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.84||0.901|TWO_SIDED|95.0|-1.55|1.76|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.76|-1.55|0.901
71002496|NCT00565812|141513062|SUPERIORITY_OR_OTHER||LS mean difference|-0.81|STANDARD_ERROR_OF_MEAN|0.84||0.333|TWO_SIDED|95.0|-2.45|0.83|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.83|-2.45|0.333
71002497|NCT00565812|141513063|SUPERIORITY_OR_OTHER||LS mean difference|2.34|STANDARD_ERROR_OF_MEAN|1.36||0.086|TWO_SIDED|95.0|-0.33|5.01|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||5.01|-0.33|0.086
71002498|NCT00565812|141513063|SUPERIORITY_OR_OTHER||LS mean difference|1.11|STANDARD_ERROR_OF_MEAN|1.36||0.415|TWO_SIDED|95.0|-1.56|3.78|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.78|-1.56|0.415
71002499|NCT00565812|141513063|SUPERIORITY_OR_OTHER||LS mean difference|0.8|STANDARD_ERROR_OF_MEAN|1.41||0.569|TWO_SIDED|95.0|-1.97|3.57|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.57|-1.97|0.569
71002500|NCT00565812|141513063|SUPERIORITY_OR_OTHER||LS mean difference|1.26|STANDARD_ERROR_OF_MEAN|1.41||0.374|TWO_SIDED|95.0|-1.51|4.02|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.02|-1.51|0.374
71042972|NCT02744755|141594599|EQUIVALENCE|A 0.6 change in DAS28-CRP score is considered as no clinically meaningful difference by EULAR criteria and is therefore used as the equivalence margin limits \[0.6,-0.6\].|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.129|||TWO_SIDED|90.0|-0.19|0.23||||||Therapeutic equivalence in terms of change from baseline in DAS28-CRP at week 12 will be concluded if the 90% confidence interval for the LS mean difference between GP2017 and Humira is contained within the interval \[-0.6; 0.6\]. A mixed-model repeated measures analysis was performed for DAS28-CRP change from baseline including treatment, stratification factors, time, the interaction between time (visits) and treatment all as categorical variables, and baseline DAS28-CRP as a continuous variable.||0.23|-0.19|
71042973|NCT02744755|141594600|EQUIVALENCE|A 0.6 change in DAS28-CRP score is considered as no clinically meaningful difference by EULAR criteria and is therefore used as the equivalence margin limits \[0.6,-0.6\].|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.096|||TWO_SIDED|95.0|-0.11|0.27|||ANCOVA|||ANCOVA model included treatment, body weight as per CRF, prior therapy as per CRF, region as per CRF as fixed effects and baseline DAS28-CRP values as covariate.||0.27|-0.11|
71100874|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with vulvar dermatosis and positive AWR?||||||0.2478|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with vulvar dermatosis and positive AWR.||||0.2478
71100875|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR?||||||0.2478|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR.||||0.2478
70924495|NCT04382404|141341427|OTHER||Geometric mean ratio|0.62|||||TWO_SIDED|90.0|0.55|0.71||||||Area under the plasma concentration versus time curve tau of Sofosbuvir was compared between the 10 pregnant women in this study to 25 non-pregnant historical control women. The geometric mean (percent coefficient of variation) for the non-pregnant cohort was 15361.31 (22.35).|The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|0.71|0.55|
70924496|NCT04382404|141341428|OTHER||Geometric mean ratio|1.43|||||TWO_SIDED|95.0|0.91|2.25||||||The geometric mean (95 percent confidence interval) concentration of GS-461203 in peripheral blood mononuclear cells was compared between the pregnant cohort and 58 nonpregnant persons. The geometric mean (95 percent confidence interval) concentration of GS-461203 was 1474 (488, 4453) fmol /10\^6 cells in the nonpregnant cohort.|The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|2.25|0.91|
71002501|NCT00565812|141513063|SUPERIORITY_OR_OTHER||LS mean difference|1.63|STANDARD_ERROR_OF_MEAN|1.53||0.288|TWO_SIDED|95.0|-1.38|4.64|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.64|-1.38|0.288
71002502|NCT00565812|141513063|SUPERIORITY_OR_OTHER||LS mean difference|1.18|STANDARD_ERROR_OF_MEAN|1.52||0.44|TWO_SIDED|95.0|-1.81|4.17|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.17|-1.81|0.440
71002503|NCT00565812|141513063|SUPERIORITY_OR_OTHER||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|1.58||0.896|TWO_SIDED|95.0|-3.3|2.88|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.88|-3.30|0.896
71002504|NCT00565812|141513063|SUPERIORITY_OR_OTHER||LS mean difference|1.14|STANDARD_ERROR_OF_MEAN|1.56||0.464|TWO_SIDED|95.0|-1.92|4.2|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.20|-1.92|0.464
71002505|NCT00565812|141513063|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|1.57||0.901|TWO_SIDED|95.0|-3.27|2.88|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.88|-3.27|0.901
71002506|NCT00565812|141513063|SUPERIORITY_OR_OTHER||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|1.56||0.8|TWO_SIDED|95.0|-3.45|2.66|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.66|-3.45|0.800
71002507|NCT00565812|141513064|SUPERIORITY_OR_OTHER||LS mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.048||0.984|TWO_SIDED|95.0|-0.093|0.095|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.095|-0.093|0.984
71042974|NCT02744755|141594600|EQUIVALENCE|A 0.6 change in DAS28-CRP score is considered as no clinically meaningful difference by EULAR criteria and is therefore used as the equivalence margin limits \[0.6,-0.6\].|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.096|||TWO_SIDED|90.0|-0.08|0.24|||ANCOVA|||ANCOVA model included treatment, body weight as per CRF, prior therapy as per CRF, region as per CRF as fixed effects and baseline DAS28-CRP values as covariate.||0.24|-0.08|
71042975|NCT00337428|141594640|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
71100876|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with vulvar dermatosis and positive AWR?||||||0.1627|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with vulvar dermatosis and positive AWR.||||0.1627
71042976|NCT00337428|141594641|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
71042977|NCT00337428|141594642|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
71002508|NCT00565812|141513064|SUPERIORITY_OR_OTHER||LS mean difference|-0.046|STANDARD_ERROR_OF_MEAN|0.048||0.33|TWO_SIDED|95.0|-0.14|0.047|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.047|-0.140|0.330
71042978|NCT00337428|141594643|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
71042979|NCT00337428|141594644|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -5%|||||<|0.001|||||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
71042980|NCT00337428|141594645|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -5%|||||<|0.001|||||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
71002509|NCT00565812|141513064|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.049||0.308|TWO_SIDED|95.0|-0.146|0.046|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.046|-0.146|0.308
71002510|NCT00565812|141513064|SUPERIORITY_OR_OTHER||LS mean difference|-0.083|STANDARD_ERROR_OF_MEAN|0.049||0.089|TWO_SIDED|95.0|-0.18|0.013|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.013|-0.180|0.089
71002511|NCT00565812|141513064|SUPERIORITY_OR_OTHER||LS mean difference|-0.035|STANDARD_ERROR_OF_MEAN|0.052||0.508|TWO_SIDED|95.0|-0.137|0.068|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.068|-0.137|0.508
71002512|NCT00565812|141513064|SUPERIORITY_OR_OTHER||LS mean difference|-0.036|STANDARD_ERROR_OF_MEAN|0.052||0.49|TWO_SIDED|95.0|-0.137|0.066|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.066|-0.137|0.490
71002513|NCT00565812|141513064|SUPERIORITY_OR_OTHER||LS mean difference|-0.019|STANDARD_ERROR_OF_MEAN|0.057||0.739|TWO_SIDED|95.0|-0.132|0.094|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.094|-0.132|0.739
71002514|NCT00565812|141513064|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.057||0.376|TWO_SIDED|95.0|-0.162|0.061|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.061|-0.162|0.376
71002515|NCT00565812|141513064|SUPERIORITY_OR_OTHER||LS mean difference|-0.008|STANDARD_ERROR_OF_MEAN|0.057||0.883|TWO_SIDED|95.0|-0.121|0.104|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.104|-0.121|0.883
71002516|NCT00565812|141513064|SUPERIORITY_OR_OTHER||LS mean difference|-0.023|STANDARD_ERROR_OF_MEAN|0.057||0.69|TWO_SIDED|95.0|-0.135|0.089|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.089|-0.135|0.690
71042981|NCT00337428|141594646|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -5%|||||<|0.001|||||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
71002517|NCT00565812|141513065|SUPERIORITY_OR_OTHER||LS mean difference|0.008|STANDARD_ERROR_OF_MEAN|0.044||0.849|TWO_SIDED|95.0|-0.078|0.095|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.095|-0.078|0.849
71002518|NCT00565812|141513065|SUPERIORITY_OR_OTHER||LS mean difference|-0.009|STANDARD_ERROR_OF_MEAN|0.044||0.837|TWO_SIDED|95.0|-0.096|0.078|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.078|-0.096|0.837
71002519|NCT00565812|141513065|SUPERIORITY_OR_OTHER||LS mean difference|-0.013|STANDARD_ERROR_OF_MEAN|0.047||0.776|TWO_SIDED|95.0|-0.105|0.078|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.078|-0.105|0.776
71002520|NCT00565812|141513065|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.047||0.033|TWO_SIDED|95.0|-0.191|-0.008|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.008|-0.191|0.033
71002521|NCT00565812|141513065|SUPERIORITY_OR_OTHER||LS mean difference|-0.064|STANDARD_ERROR_OF_MEAN|0.05||0.201|TWO_SIDED|95.0|-0.163|0.034|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.034|-0.163|0.201
71042982|NCT00337428|141594647|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -5%|||||<|0.001|||||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
71042983|NCT00337428|141594648|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%|||||<|0.001||95.0|||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
70924497|NCT04382404|141341429|OTHER||Geometric mean ratio|1.91|||||TWO_SIDED|95.0|1.14|3.19|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|The geometric mean (95 percent confidence interval) concentration of GS-461203 in peripheral blood mononuclear cells was compared between the pregnant cohort and 58 nonpregnant persons. The geometric mean (95 percent confidence interval) concentration of GS-461203 was 1474 (488, 4453) fmol /10\^6 cells in the nonpregnant cohort.||3.19|1.14|
71002522|NCT00565812|141513065|SUPERIORITY_OR_OTHER||LS mean difference|-0.103|STANDARD_ERROR_OF_MEAN|0.05||0.038|TWO_SIDED|95.0|-0.201|-0.006|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.006|-0.201|0.038
71002523|NCT00565812|141513065|SUPERIORITY_OR_OTHER||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.053||0.848|TWO_SIDED|95.0|-0.114|0.094|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.094|-0.114|0.848
71002524|NCT00565812|141513065|SUPERIORITY_OR_OTHER||LS mean difference|-0.019|STANDARD_ERROR_OF_MEAN|0.052||0.714|TWO_SIDED|95.0|-0.122|0.084|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.084|-0.122|0.714
71002525|NCT00565812|141513065|SUPERIORITY_OR_OTHER||LS mean difference|0.025|STANDARD_ERROR_OF_MEAN|0.054||0.652|TWO_SIDED|95.0|-0.082|0.131|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.131|-0.082|0.652
71002526|NCT00565812|141513065|SUPERIORITY_OR_OTHER||LS mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.054||0.7|TWO_SIDED|95.0|-0.085|0.127|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.127|-0.085|0.700
71002527|NCT00565812|141513066|SUPERIORITY_OR_OTHER||LS mean difference|1.68|STANDARD_ERROR_OF_MEAN|1.37||0.22|TWO_SIDED|95.0|-1.0|4.36|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.36|-1.00|0.220
71002528|NCT00565812|141513066|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|1.36||0.997|TWO_SIDED|95.0|-2.67|2.68|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.68|-2.67|0.997
71002529|NCT00565812|141513066|SUPERIORITY_OR_OTHER||LS mean difference|0.73|STANDARD_ERROR_OF_MEAN|1.44||0.613|TWO_SIDED|95.0|-2.09|3.55|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.55|-2.09|0.613
71002530|NCT00565812|141513066|SUPERIORITY_OR_OTHER||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|1.44||0.964|TWO_SIDED|95.0|-2.75|2.88|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.88|-2.75|0.964
71002531|NCT00565812|141513066|SUPERIORITY_OR_OTHER||LS mean difference|0.24|STANDARD_ERROR_OF_MEAN|1.49||0.872|TWO_SIDED|95.0|-2.69|3.17|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.17|-2.69|0.872
71002532|NCT00565812|141513066|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|1.48||0.947|TWO_SIDED|95.0|-2.81|3.01|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.01|-2.81|0.947
71002533|NCT00565812|141513066|SUPERIORITY_OR_OTHER||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|1.62||0.927|TWO_SIDED|95.0|-3.03|3.33|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.33|-3.03|0.927
71002534|NCT00565812|141513066|SUPERIORITY_OR_OTHER||LS mean difference|0.97|STANDARD_ERROR_OF_MEAN|1.61||0.547|TWO_SIDED|95.0|-2.18|4.12|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.12|-2.18|0.547
71002535|NCT00565812|141513066|SUPERIORITY_OR_OTHER||LS mean difference|1.62|STANDARD_ERROR_OF_MEAN|1.58||0.304|TWO_SIDED|95.0|-1.47|4.71|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.71|-1.47|0.304
71002536|NCT00565812|141513066|SUPERIORITY_OR_OTHER||LS mean difference|-0.65|STANDARD_ERROR_OF_MEAN|1.57||0.679|TWO_SIDED|95.0|-3.73|2.43|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.43|-3.73|0.679
71002537|NCT00565812|141513067|SUPERIORITY_OR_OTHER||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|1.11||0.738|TWO_SIDED|95.0|-1.8|2.55|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.55|-1.80|0.738
71042984|NCT00337428|141594649|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%|||||<|0.001||95.0|||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
71042985|NCT00337428|141594650|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%|||||<|0.001||95.0|||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
71042986|NCT00337428|141594651|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%|||||<|0.001||95.0|||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
71042987|NCT00337428|141594652|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%|||||<|0.001||95.0|||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
71042988|NCT00337428|141594653|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.67.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
71042989|NCT00337428|141594654|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.67.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
71042990|NCT00337428|141594655|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.67.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
71042991|NCT00337428|141594656|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.67.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
71002538|NCT00565812|141513067|SUPERIORITY_OR_OTHER||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|1.11||0.632|TWO_SIDED|95.0|-2.7|1.64|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.64|-2.70|0.632
71042992|NCT02020967|141594698|OTHER||Odds Ratio (OR)|7.34||||0.0196|TWO_SIDED|95.0|1.38|39.11|||Regression, Logistic|||Predictor variable: Lips enlargement||39.11|1.38|0.0196
71042993|NCT02508116|141594741|SUPERIORITY||Odds Ratio (OR)|1.6||||0.03|TWO_SIDED|95.0|1.07|2.42|||Regression, Logistic|||The sample size calculation was based on two factors: 1) the rate of pre-study prasugrel/ticagrelor use (\~20%) and 2) anticipated increase in prasugrel/ticagrelor prescribing based on the frequency CYP2C19 LOF variants (\~30-35%). We estimated a 15% difference in the use of prasugrel/ticagrelor in the two groups (35% in the genotyped group and 20% in the control group). A sample size of 138 per group (a total of 276) would provide 80% power at an alpha level of 0.05 to detect this difference.||2.42|1.07|0.03
71042994|NCT02508116|141594743|SUPERIORITY|||||||0.27|||||||Log Rank|||The incidence of first MACE between the groups were compared by use of Kaplan-Meier estimators; statistical tests were based on log-rank tests.||||0.27
71042995|NCT02630316|141594745|SUPERIORITY||Hodges-Lehmann|21.0||||0.0043|TWO_SIDED|95.0|7.0|37.0||p-value is obtained from nonparametric ANCOVA adjusted for Baseline 6MWD category.|ANCOVA|||||37.0|7.0|0.0043
71042996|NCT02630316|141594746|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71042997|NCT02630316|141594747|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.041|TWO_SIDED|95.0|0.4|0.92||p-value is calculated with log-rank test stratified by baseline 6MWD category.|Log Rank||p-value was 0.0202 for the proportional hazard model. Hazard ratio, 95% confidence interval (CI), and p-values are calculated with proportional hazards model with treatment and Baseline 6MWD (continuous) as explanatory variables.|||0.92|0.40|0.0410
71042998|NCT02630316|141594748|SUPERIORITY||Hodges-Lehmann|20.0||||0.0041|TWO_SIDED|95.0|7.0|34.0||p-value is obtained from nonparametric ANCOVA adjusted for Baseline 6MWD category|ANCOVA|||||34.0|7.0|0.0041
71042999|NCT02630316|141594749|SUPERIORITY||Hodges-Lehmann|15.0||||0.0432|TWO_SIDED|95.0|0.0|29.0||p-value is obtained from nonparametric ANCOVA adjusted for Baseline 6MWD category.|ANCOVA|||||29.0|0.0|0.0432
71043000|NCT00559364|141594754|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Analysis of covariance (ANCOVA) model using treatment group and pooled site as fixed effects and wash-out phase CFA% value as covariate was used.||||<0.0001
71043001|NCT02578745|141594757|SUPERIORITY||Risk Ratio (RR)|1.67||||0.72|TWO_SIDED|95.0|0.42|6.67|||Chi-squared|||||6.67|.42|0.72
71043002|NCT02578745|141594758|SUPERIORITY||Risk Ratio (RR)|1.67||||0.72|TWO_SIDED|95.0|0.42|6.67|||Chi-squared|||||6.67|.42|0.72
71100877|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with vulvar dermatosis and positive AWR?||||||0.5943|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with vulvar dermatosis and positive AWR.||||0.5943
70924498|NCT04382404|141341430|OTHER||Geometric mean ratio|1.5|||||TWO_SIDED|95.0|0.87|2.6|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|The geometric mean (95 percent confidence interval) concentration of GS-461203 in peripheral blood mononuclear cells was compared between the pregnant cohort and 58 nonpregnant persons. The geometric mean (95 percent confidence interval) concentration of GS-461203 was 1474 (488, 4453) fmol /10\^6 cells in the nonpregnant cohort.||2.60|0.87|
70924499|NCT04382404|141341431|OTHER||Geometric mean ratio|0.53|||||TWO_SIDED|95.0|0.5|0.56|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|The geometric mean (95 percent confidence interval) concentration of GS-461203 in dried blood spots was compared between the pregnant cohort and 58 nonpregnant persons. The geometric mean (95 percent confidence interval) concentration of GS-461203 was 647 (571, 723) fmol/punch in the nonpregnant cohort.||.56|.50|
70924500|NCT04382404|141341432|OTHER||Geometric mean ratio|0.53|||||TWO_SIDED|95.0|0.49|0.58|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|The geometric mean (95 percent confidence interval) concentration of GS-461203 in dried blood spots was compared between the pregnant cohort and 58 nonpregnant persons. The geometric mean (95 percent confidence interval) concentration of GS-461203 was 647 (571, 723) fmol/punch in the nonpregnant cohort.||.58|.49|
70924501|NCT04382404|141341433|OTHER||Geometric mean ratio|0.55|||||TWO_SIDED|95.0|0.48|0.64|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|The geometric mean (95 percent confidence interval) concentration of GS-461203 in dried blood spots was compared between the pregnant cohort and 58 nonpregnant persons. The geometric mean (95 percent confidence interval) concentration of GS-461203 was 647 (571, 723) fmol/punch in the nonpregnant cohort.||.64|.48|
70924502|NCT02960893|141341458|SUPERIORITY||LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.4||0.519|TWO_SIDED|95.0|-0.5|0.9||Significance was evaluated at a 2-sided alpha level of 0.05|Mixed Model with Repeated Measures|Fixed effects: treatment, baseline (BL) gait severity, visit, treatment-by-visit interaction; Covariate: BL Total SARA score; Random effect: subject||||0.9|-0.5|0.519
70924503|NCT05687916|141341469|SUPERIORITY||LS Mean Difference Estimate|-0.24|STANDARD_ERROR_OF_MEAN|3.277|=|0.989|TWO_SIDED|95.0|-6.67|6.18||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||6.18|-6.67|=0.989
70924504|NCT05687916|141341469|SUPERIORITY||LS Mean Difference Estimate|2.4|STANDARD_ERROR_OF_MEAN|3.227|=|0.916|TWO_SIDED|95.0|-3.93|8.72||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||8.72|-3.93|=0.916
70924505|NCT05687916|141341470|SUPERIORITY||LS Mean Difference Estimate|-0.32|STANDARD_ERROR_OF_MEAN|1.656|=|0.989|TWO_SIDED|95.0|-3.57|2.92||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.|LS in LS Mean Difference denotes least squares.|||2.92|-3.57|=0.989
70924506|NCT05687916|141341470|SUPERIORITY||LS Mean Difference Estimate|-3.06|STANDARD_ERROR_OF_MEAN|1.59|=|0.216|TWO_SIDED|95.0|-6.18|0.06||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||0.06|-6.18|=0.216
70924507|NCT02651428|141341478|SUPERIORITY||Hazard Ratio (HR)|0.29||||0.0006|TWO_SIDED|95.0|0.14|0.62||The threshold significance level at the interim and final statistical analyses for the primary efficacy endpoint was 0.0294.|Log Rank||The numerator for the hazard ratio was the estimated hazard for the Neutrolin treatment arm, and the denominator was the estimated hazard for the Heparin treatment arm.|The null hypothesis was that there was no difference in the survival functions for CRBSI between the two treatments. Based on 80% power to detect a 55% reduction in the risk of CRBSI relative to the control treatment, a 1:1 randomization, a 2-sided log-rank test, one interim analysis using the method of Pocock, and an overall alpha of 0.05, it was determined that 56 CRBSIs would be needed. These are the results of the final analysis.||0.62|0.14|0.0006
70924508|NCT02651428|141341479|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.4161|TWO_SIDED|95.0|0.9|1.29||The threshold for statistical significance was p \< 0.05.|Log Rank||The numerator for the hazard ratio was the estimated hazard for the Neutrolin treatment arm, and the denominator was the estimated hazard for the Heparin treatment arm.|The null hypothesis was that there was no difference in the time until catheter removal for any reason between the two treatments.||1.29|0.90|0.4161
71043003|NCT02578745|141594759|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
71043004|NCT02578745|141594760|SUPERIORITY||||||>|0.99|TWO_SIDED|95.0|||||Chi-squared|||||||>0.99
71043005|NCT02578745|141594761|SUPERIORITY||||||>|0.99|||||||Chi-squared|||||||>0.99
71043006|NCT02578745|141594762|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.50
71043007|NCT00330460|141594765|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -1.22%.|Mean Difference (Final Values)|1.0|||<|0.0001||95.0|0.7|1.2|||ANCOVA|||||1.2|0.7|<0.0001
71043008|NCT00330460|141594766|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -2.29%.|Mean Difference (Final Values)|1.1|||<|0.0001||95.0|0.7|1.4||The reported p-value was the one-sided adjusted p-valued based on multiplicity adjustment of the secondary efficacy endpoints|ANCOVA|||||1.4|0.7|<0.0001
71100878|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with vulvar dermatosis and positive AWR?||||||0.7161|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with vulvar dermatosis and positive AWR.||||0.7161
71002539|NCT00565812|141513067|SUPERIORITY_OR_OTHER||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|1.21||0.736|TWO_SIDED|95.0|-2.77|1.96|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.96|-2.77|0.736
71002540|NCT00565812|141513067|SUPERIORITY_OR_OTHER||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|1.21||0.811|TWO_SIDED|95.0|-2.66|2.08|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.08|-2.66|0.811
71002541|NCT00565812|141513067|SUPERIORITY_OR_OTHER||LS mean difference|-1.22|STANDARD_ERROR_OF_MEAN|1.27||0.335|TWO_SIDED|95.0|-3.71|1.26|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.26|-3.71|0.335
71002542|NCT00565812|141513067|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|1.26||0.966|TWO_SIDED|95.0|-2.52|2.41|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.41|-2.52|0.966
71002543|NCT00565812|141513067|SUPERIORITY_OR_OTHER||LS mean difference|-1.44|STANDARD_ERROR_OF_MEAN|1.38||0.299|TWO_SIDED|95.0|-4.16|1.28|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.28|-4.16|0.299
71002544|NCT00565812|141513067|SUPERIORITY_OR_OTHER||LS mean difference|0.13|STANDARD_ERROR_OF_MEAN|1.37||0.925|TWO_SIDED|95.0|-2.56|2.82|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.82|-2.56|0.925
71002545|NCT00565812|141513067|SUPERIORITY_OR_OTHER||LS mean difference|0.58|STANDARD_ERROR_OF_MEAN|1.39||0.676|TWO_SIDED|95.0|-2.14|3.3|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.30|-2.14|0.676
71043009|NCT00330460|141594767|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -1.65%|Mean Difference (Final Values)|1.0|||<|0.0001||95.0|0.6|1.4||The reported p-value was the one-sided adjusted p-valued based on multiplicity adjustment of the secondary efficacy endpoints|ANCOVA|||||1.4|0.6|<0.0001
71002546|NCT00565812|141513067|SUPERIORITY_OR_OTHER||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|1.38||0.732|TWO_SIDED|95.0|-3.18|2.23|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.23|-3.18|0.732
71002547|NCT00565812|141513068|SUPERIORITY_OR_OTHER||LS mean difference|0.13|STANDARD_ERROR_OF_MEAN|1.2||0.911|TWO_SIDED|95.0|-2.22|2.49|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.49|-2.22|0.911
71043010|NCT00330460|141594768|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -1.04%|Mean Difference (Final Values)|0.6|||<|0.0001||95.0|0.3|1.0||The reported p-value was the one-sided adjusted p-valued based on multiplicity adjustment of the secondary efficacy endpoints|ANCOVA|||||1|0.3|<0.0001
71043011|NCT00330460|141594769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.0001||95.0|0.3|0.9||The reported p-value was the one-sided adjusted p-valued based on multiplicity adjustment of the secondary efficacy endpoints|ANCOVA|||||0.9|0.3|0.0001
71043012|NCT02663882|141594770|SUPERIORITY|||||||0.503||||||the a priori threshold for statistical significance was p\<0.05|ANOVA|||The non-smoking-related self control task was the comparison group in relation to the smoking-related self control task||||0.503
71043013|NCT02663882|141594771|SUPERIORITY|||||||0.765||||||the a priori threshold for statistical significance was p\<0.05|ANOVA|||The non-smoking-related self control task was the comparison group in relation to the smoking-related self control task||||0.765
71043014|NCT02663882|141594772|SUPERIORITY|||||||0.717||||||the a priori threshold for statistical significance was p=0.05|ANOVA|||The non-smoking-related self control task was the comparison group in relation to the smoking-related self control task||||0.717
71043015|NCT02663882|141594773|SUPERIORITY|||||||0.302||||||the a priori threshold for statistical significance was p=0.05|ANOVA|||The non-smoking-related self control task was the comparison group in relation to the smoking-related self control task||||0.302
71043016|NCT05070390|141594775|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|Geometric Mean Ratio (GMR)|1.23|||||TWO_SIDED|90.0|0.62|2.44|||||GMR and 90% confidence interval (CI) were estimated using a linear mixed effects model and referencing a t-distribution.|||2.44|0.62|
71043017|NCT05070390|141594776|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|1.63|||||TWO_SIDED|90.0|0.55|4.83|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||4.83|0.55|
71043018|NCT05070390|141594777|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|1.45|||||TWO_SIDED|90.0|0.7|2.99|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||2.99|0.70|
70924509|NCT04005716|141341493|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.004|TWO_SIDED|95.0|0.61|0.93|||Log Rank|Stratified log rank test with ECOG performance status, and investigator chosen platinum as stratification factors.|The hazard ratio was estimated using a stratified Cox regression model with Efron's method for ties, stratified by ECOG performance status and investigator-selected platinum agents, with Arm B as the reference group.|The null hypothesis stated that the overall survival in Arm A (Tislelizumab + Chemotherapy) is less than or equal to that in Arm B (the placebo group), while the alternative hypothesis posits that the overall survival in Arm A is greater than that in Arm B.||0.93|0.61|0.0040
70924510|NCT04005716|141341494|SUPERIORITY||Hazard Ratio (HR)|0.64|||<|0.0001|TWO_SIDED|95.0|0.52|0.78|||Log Rank|One-sided log-rank test p-value, stratified by ECOG performance status (1 vs 0) and type of platinum therapy (carboplatin vs cisplatin).|The hazard ratio was estimated using a stratified Cox regression model with Efron's method for ties, stratified by ECOG performance status and investigator-selected platinum agents, with Arm B as the reference group.|||0.78|0.52|<0.0001
70924511|NCT04005716|141341495|OTHER||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.9|1.96|||||Odds ratio was calculated using Cochran-Mantel-Haenszel estimates and stratified by ECOG performance (1 vs 0) and platinum (Carboplatin vs Cisplatin)|||1.96|0.90|
70924512|NCT04005716|141341502|OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.642|1.33|||||Hazard ratio was based on unstratified Cox regression model including treatment as covariate.|Analyses of Time to Deterioration of EORTC QLQ-C30 Physical Functioning Score||1.330|0.642|
70924513|NCT04005716|141341502|OTHER||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.473|1.123|||||Hazard ratio was based on unstratified Cox regression model including treatment as covariate.|Analyses of Time to Deterioration of EORTC QLQ-LC13 Coughing Score||1.123|0.473|
70924514|NCT04005716|141341502|OTHER||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.485|1.057|||||Hazard ratio was based on unstratified Cox regression model including treatment as covariate.|Analyses of Time to Deterioration of EORTC QLQ-LC13 Chest Pain Score||1.057|0.485|
70924515|NCT03892616|141341588|OTHER||Ratio of adjusted geometric means [%]|97.4|||||TWO_SIDED|90.0|82.3|115.3|||||The ratio was calculated as adjusted geometric mean of TF2a fasted (C) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 25.44|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||115.3|82.3|
71043019|NCT05070390|141594780|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|0.82|||||TWO_SIDED|90.0|0.41|1.62|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||1.62|0.41|
71043020|NCT05070390|141594781|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|0.92|||||TWO_SIDED|90.0|0.6|1.42|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||1.42|0.60|
71043021|NCT05070390|141594784|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|0.82|||||TWO_SIDED|90.0|0.22|3.1|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||3.10|0.22|
71043022|NCT05070390|141594785|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|0.82|||||TWO_SIDED|90.0|0.22|3.1|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||3.10|0.22|
71043023|NCT05070390|141594786|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|0.38|||||TWO_SIDED|90.0|0.13|1.13|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||1.13|0.13|
71043024|NCT02013531|141594866|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||The null hypothesis of zero in mean change from Baseline in the MADRS total score at Week 6 was tested at a significance level of 0.05. Because this was an exploratory trial, no methods to control type I error rate were performed.||||<0.0001
71043025|NCT02013531|141594867|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measure (MMRM) with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 6.||||<0.0001
71043026|NCT02013531|141594873|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measure (MMRM) with model terms: Baseline, visit, and Baseline by visit interaction||The null hypothesis of zero in Mean change from Baseline in HAM-A total score at Week 6 was tested at a significance level of 0.05. Because this was an exploratory trial, no methods to control type I error rate were performed.||||<0.0001
71043027|NCT03396874|141594889|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|PPV|87.3|||<|1e-07|TWO_SIDED|95.0|81.58|100.0||The exact p-value cannot be entered as it is equal to 2.2e-16.|Exact binomial proportion test|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)||We determined the positive predictive value (PPV) (true positives / (true positives + false positives)) of 68Ga-PSMA-11 PET for presence or absence of prostate cancer confirmed by histopathology on a per-patient basis. On a per-patient basis, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%.||100.00|81.58|<0.0000001
71043028|NCT03396874|141594890|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|PPV|92.3|||<|1e-07|TWO_SIDED|95.0|90.0|100.0||Per patient basis p-value = 2.2e-16|binomial proportion test|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)||PPV, composite standard, per-patient basis: We determined the positive predictive value (PPV) of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy where available. On a per-patient basis, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%.||100|90.0|<0.0000001
71002548|NCT00565812|141513068|SUPERIORITY_OR_OTHER||LS mean difference|-0.81|STANDARD_ERROR_OF_MEAN|1.2||0.5|TWO_SIDED|95.0|-3.16|1.54|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.54|-3.16|0.500
71100879|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with vulvar dermatosis and positive AWR?||||||0.3301|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with vulvar dermatosis and positive AWR.||||0.3301
71002549|NCT00565812|141513068|SUPERIORITY_OR_OTHER||LS mean difference|0.67|STANDARD_ERROR_OF_MEAN|1.26||0.596|TWO_SIDED|95.0|-1.81|3.15|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.15|-1.81|0.596
71002550|NCT00565812|141513068|SUPERIORITY_OR_OTHER||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|1.26||0.979|TWO_SIDED|95.0|-2.51|2.44|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.44|-2.51|0.979
71002551|NCT00565812|141513068|SUPERIORITY_OR_OTHER||LS mean difference|-0.59|STANDARD_ERROR_OF_MEAN|1.33||0.659|TWO_SIDED|95.0|-3.2|2.03|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.03|-3.20|0.659
71002552|NCT00565812|141513068|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|1.32||0.823|TWO_SIDED|95.0|-2.89|2.3|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.30|-2.89|0.823
71002553|NCT00565812|141513068|SUPERIORITY_OR_OTHER||LS mean difference|-1.24|STANDARD_ERROR_OF_MEAN|1.43||0.387|TWO_SIDED|95.0|-4.04|1.57|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.57|-4.04|0.387
71002554|NCT00565812|141513068|SUPERIORITY_OR_OTHER||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|1.42||0.737|TWO_SIDED|95.0|-3.25|2.3|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.30|-3.25|0.737
71002555|NCT00565812|141513068|SUPERIORITY_OR_OTHER||LS mean difference|1.12|STANDARD_ERROR_OF_MEAN|1.45||0.443|TWO_SIDED|95.0|-1.73|3.97|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.97|-1.73|0.443
71002556|NCT00565812|141513068|SUPERIORITY_OR_OTHER||LS mean difference|-0.79|STANDARD_ERROR_OF_MEAN|1.44||0.585|TWO_SIDED|95.0|-3.62|2.04|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.04|-3.62|0.585
71100880|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR?||||||0.3301|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR.||||0.3301
71002557|NCT00565812|141513069|SUPERIORITY_OR_OTHER||LS mean difference|0.58|STANDARD_ERROR_OF_MEAN|1.16||0.613|TWO_SIDED|95.0|-1.68|2.85|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.85|-1.68|0.613
71002558|NCT00565812|141513069|SUPERIORITY_OR_OTHER||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|1.16||0.67|TWO_SIDED|95.0|-2.76|1.78|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.78|-2.76|0.670
71002559|NCT00565812|141513069|SUPERIORITY_OR_OTHER||LS mean difference|-1.33|STANDARD_ERROR_OF_MEAN|1.27||0.296|TWO_SIDED|95.0|-3.82|1.16|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.16|-3.82|0.296
70924516|NCT03892616|141341588|OTHER||Ratio of adjusted geometric means [%]|183.0|||||TWO_SIDED|90.0|154.0|217.4|||||The ratio was calculated as adjusted geometric mean of TF2b fasted (E) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 25.44|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||217.4|154.0|
71002560|NCT00565812|141513069|SUPERIORITY_OR_OTHER||LS mean difference|-0.66|STANDARD_ERROR_OF_MEAN|1.27||0.604|TWO_SIDED|95.0|-3.15|1.83|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.83|-3.15|0.604
71002561|NCT00565812|141513069|SUPERIORITY_OR_OTHER||LS mean difference|-1.86|STANDARD_ERROR_OF_MEAN|1.33||0.163|TWO_SIDED|95.0|-4.46|0.75|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.75|-4.46|0.163
71002562|NCT00565812|141513069|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|1.32||0.939|TWO_SIDED|95.0|-2.69|2.48|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.48|-2.69|0.939
71002563|NCT00565812|141513069|SUPERIORITY_OR_OTHER||LS mean difference|-1.74|STANDARD_ERROR_OF_MEAN|1.46||0.233|TWO_SIDED|95.0|-4.61|1.12|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.12|-4.61|0.233
71002564|NCT00565812|141513069|SUPERIORITY_OR_OTHER||LS mean difference|0.52|STANDARD_ERROR_OF_MEAN|1.45||0.72|TWO_SIDED|95.0|-2.32|3.36|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.36|-2.32|0.720
71043029|NCT03396874|141594890|OTHER|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Sensitivity|95.29|||<|1e-07|TWO_SIDED|95.0|93.3|100.0||Per patient basis p-value = 2.2e-16|Sensitivity|||Sensitivity, composite standard, per-patient basis: We determined the sensitivity of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy (composite standard of truth). On a per-patient basis, the sensitivity of conventional imaging ranges between 30-50%. The null hypothesis is that the sensitivity at 50% will be tested against the alternative hypothesis that the sensitivity is greater than 50%.||100.00|93.3|<0.0000001
71043030|NCT03396874|141594890|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Sensitivity|91.1|||<|1e-07|TWO_SIDED|95.0|86.2|100.0||p-value = 2.2e-16|Exact binomial proportion test|||PPV, composite standard, prostate or prostate bed: PPV of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy where available (composite standard of truth). In the prostate or prostate bed, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%.||100.00|86.2|<0.0000001
71043031|NCT03396874|141594890|OTHER|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Sensitivity|91.72|||<|1e-07|TWO_SIDED|95.0|86.74|100.0||p-value = 2.2e-16 Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Exact binomial proportion test|||Sensitivity, composite standard, prostate/prostate bed: We determined the sensitivity of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy (composite standard of truth). In the prostate or prostate bed, the sensitivity of conventional imaging ranges between 30-50%. The null hypothesis is that the sensitivity at 50% will be tested against the alternative hypothesis that the sensitivity is greater than 50%.||100.00|86.74|<0.0000001
71043032|NCT03396874|141594890|OTHER|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|PPV|90.78|||<|1e-07|TWO_SIDED|95.0|85.74|100.0||p-value = 2.2e-16|Exact binomial proportion test|||PPV, composite standard, pelvic lymph nodes: PPV of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy where available (composite standard of truth). In the prostate or prostate bed, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%.||100.00|85.74|<0.0000001
71002565|NCT00565812|141513069|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|1.45||0.993|TWO_SIDED|95.0|-2.82|2.85|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.85|-2.82|0.993
70924517|NCT03892616|141341588|OTHER||Ratio of adjusted geometric means [%]|114.8|||||TWO_SIDED|90.0|96.5|136.6|||||The ratio was calculated as adjusted geometric mean of TF2a fed (B) as numerator and adjusted geometric mean of TF2a fasted (C) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 25.44|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||136.6|96.5|
71100881|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with vulvar dermatosis and positive AWR?||||||0.1627|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with vulvar dermatosis and positive AWR.||||0.1627
71100882|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with vulvar dermatosis and positive AWR?||||||0.4742|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with vulvar dermatosis and positive AWR.||||0.4742
70924518|NCT03892616|141341588|OTHER||Ratio of adjusted geometric means [%]|66.5|||||TWO_SIDED|90.0|55.5|79.5|||||The ratio was calculated as adjusted geometric mean of TF2b fed (D) as numerator and adjusted geometric mean of TF2b fasted (E) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 25.44|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||79.5|55.5|
71002566|NCT00565812|141513069|SUPERIORITY_OR_OTHER||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|1.44||0.794|TWO_SIDED|95.0|-3.19|2.44|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.44|-3.19|0.794
71002567|NCT00565812|141513070|SUPERIORITY_OR_OTHER||LS mean difference|0.97|STANDARD_ERROR_OF_MEAN|0.53||0.069|TWO_SIDED|95.0|-0.07|2.02|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.02|-0.07|0.069
71002568|NCT00565812|141513070|SUPERIORITY_OR_OTHER||LS mean difference|0.52|STANDARD_ERROR_OF_MEAN|0.54||0.335|TWO_SIDED|95.0|-0.53|1.57|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.57|-0.53|0.335
71002569|NCT00565812|141513070|SUPERIORITY_OR_OTHER||LS mean difference|0.89|STANDARD_ERROR_OF_MEAN|0.62||0.153|TWO_SIDED|95.0|-0.33|2.11|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.11|-0.33|0.153
71002570|NCT00565812|141513070|SUPERIORITY_OR_OTHER||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.62||0.672|TWO_SIDED|95.0|-0.95|1.47|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.47|-0.95|0.672
71043033|NCT03396874|141594890|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Sensitivity|96.97|||<|1e-07|TWO_SIDED|95.0|93.2|100.0||p-value = 2.2e-16|Exact binomial proportion test|||Sensitivity, composite standard, pelvic lymph nodes: We determined the sensitivity of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy (composite standard of truth). In pelvic lymph nodes, the sensitivity of conventional imaging ranges between 30-50%. The null hypothesis is that the sensitivity at 50% will be tested against the alternative hypothesis that the sensitivity is greater than 50%.||100.00|93.20|<0.0000001
71100883|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Urethral Sulcus versus Urethral Meatus in patients with vulvar dermatosis and positive AWR?||||||0.1822|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Urethral Sulcus versus Urethral Meatus in patients with vulvar dermatosis and positive AWR.||||0.1822
71100884|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Urethral Sulcus versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR?||||||0.1822|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Urethral Sulcus versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR.||||0.1822
71002571|NCT00565812|141513070|SUPERIORITY_OR_OTHER||LS mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.63||0.765|TWO_SIDED|95.0|-1.05|1.43|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.43|-1.05|0.765
71002572|NCT00565812|141513070|SUPERIORITY_OR_OTHER||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.62||0.675|TWO_SIDED|95.0|-0.96|1.49|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.49|-0.96|0.675
71002573|NCT00565812|141513070|SUPERIORITY_OR_OTHER||LS mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.72||0.56|TWO_SIDED|95.0|-1.0|1.84|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.84|-1.00|0.560
71002574|NCT00565812|141513070|SUPERIORITY_OR_OTHER||LS mean difference|0.56|STANDARD_ERROR_OF_MEAN|0.72||0.433|TWO_SIDED|95.0|-0.84|1.97|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.97|-0.84|0.433
71002575|NCT00565812|141513070|SUPERIORITY_OR_OTHER||LS mean difference|0.73|STANDARD_ERROR_OF_MEAN|0.73||0.318|TWO_SIDED|95.0|-0.7|2.16|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.16|-0.70|0.318
71002576|NCT00565812|141513070|SUPERIORITY_OR_OTHER||LS mean difference|0.75|STANDARD_ERROR_OF_MEAN|0.73||0.303|TWO_SIDED|95.0|-0.68|2.18|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.18|-0.68|0.303
71002577|NCT00565812|141513071|SUPERIORITY_OR_OTHER||LS mean difference|1.67|STANDARD_ERROR_OF_MEAN|0.81||0.039|TWO_SIDED|95.0|0.08|3.26|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLGU\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.26|0.08|0.039
71002578|NCT00565812|141513071|SUPERIORITY_OR_OTHER||LS mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.82||0.395|TWO_SIDED|95.0|-0.91|2.3|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.30|-0.91|0.395
71002579|NCT00565812|141513071|SUPERIORITY_OR_OTHER||LS mean difference|1.36|STANDARD_ERROR_OF_MEAN|0.96||0.16|TWO_SIDED|95.0|-0.54|3.25|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.25|-0.54|0.160
71043034|NCT03396874|141594890|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|PPV|91.25|||<|1e-07|TWO_SIDED|95.0|84.19|100.0||p-value = 2.9e-15|Exact binomial proportion test|||PPV, composite standard, soft tissues: PPV of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy where available (composite standard of truth). In soft tissues, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%.||100.00|84.19|<0.0000001
71002580|NCT00565812|141513071|SUPERIORITY_OR_OTHER||LS mean difference|0.46|STANDARD_ERROR_OF_MEAN|0.97||0.638|TWO_SIDED|95.0|-1.44|2.35|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.35|-1.44|0.638
71002581|NCT00565812|141513071|SUPERIORITY_OR_OTHER||LS mean difference|0.61|STANDARD_ERROR_OF_MEAN|0.98||0.537|TWO_SIDED|95.0|-1.32|2.54|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.54|-1.32|0.537
71002582|NCT00565812|141513071|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.98||0.988|TWO_SIDED|95.0|-1.9|1.93|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*(visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.93|-1.90|0.988
71002583|NCT00565812|141513071|SUPERIORITY_OR_OTHER||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|1.11||0.962|TWO_SIDED|95.0|-2.12|2.22|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.22|-2.12|0.962
71002584|NCT00565812|141513071|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|1.11||0.856|TWO_SIDED|95.0|-1.97|2.37|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.37|-1.97|0.856
71002585|NCT00565812|141513071|SUPERIORITY_OR_OTHER||LS mean difference|1.36|STANDARD_ERROR_OF_MEAN|1.15||0.237|TWO_SIDED|95.0|-0.9|3.63|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.63|-0.90|0.237
71002586|NCT00565812|141513071|SUPERIORITY_OR_OTHER||LS mean difference|0.82|STANDARD_ERROR_OF_MEAN|1.15||0.475|TWO_SIDED|95.0|-1.44|3.09|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.09|-1.44|0.475
71002587|NCT00565812|141513072|SUPERIORITY_OR_OTHER||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.57||0.938|TWO_SIDED|95.0|-1.07|1.16|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.16|-1.07|0.938
71002588|NCT00565812|141513072|SUPERIORITY_OR_OTHER||LS mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.56||0.906|TWO_SIDED|95.0|-1.04|1.17|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.17|-1.04|0.906
71002589|NCT00565812|141513072|SUPERIORITY_OR_OTHER||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.65||0.726|TWO_SIDED|95.0|-1.5|1.04|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.04|-1.50|0.726
71002590|NCT00565812|141513072|SUPERIORITY_OR_OTHER||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.64||0.681|TWO_SIDED|95.0|-1.52|1.0|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.00|-1.52|0.681
71002591|NCT00565812|141513073|SUPERIORITY_OR_OTHER||LS mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.58||0.9|TWO_SIDED|95.0|-1.07|1.21|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.21|-1.07|0.900
71043035|NCT03396874|141594890|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Sensitivity|93.59|||<|1e-07|TWO_SIDED|95.0|86.99|100.0||p-value = 2.2e-16|Exact binomial proportion test|||Sensitivity, composite standard, soft tissues: We determined the sensitivity of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy (composite standard of truth). In soft tissues, the sensitivity of conventional imaging ranges between 30-50%. The null hypothesis is that the sensitivity at 50% will be tested against the alternative hypothesis that the sensitivity is greater than 50%.||100.00|86.99|<0.0000001
71043036|NCT03396874|141594890|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|PPV|95.17|||<|1e-07|TWO_SIDED|95.0|91.12|100.0||p-value = 2.2e-16|Exact binomial proportion test|||PPV, composite standard, bone: PPV of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy where available (composite standard of truth). In bone tissues, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%.||100.00|91.12|<0.0000001
71002592|NCT00565812|141513073|SUPERIORITY_OR_OTHER||LS mean difference|0.36|STANDARD_ERROR_OF_MEAN|0.58||0.528|TWO_SIDED|95.0|-0.77|1.5|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.50|-0.77|0.528
71002593|NCT00565812|141513073|SUPERIORITY_OR_OTHER||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.62||0.647|TWO_SIDED|95.0|-1.51|0.94|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.94|-1.51|0.647
71002594|NCT00565812|141513073|SUPERIORITY_OR_OTHER||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.62||0.841|TWO_SIDED|95.0|-1.34|1.09|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.09|-1.34|0.841
71002595|NCT00565812|141513074|SUPERIORITY_OR_OTHER||LS mean difference|0.32|STANDARD_ERROR_OF_MEAN|0.59||0.587|TWO_SIDED|95.0|-0.84|1.48|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.48|-0.84|0.587
71002596|NCT00565812|141513074|SUPERIORITY_OR_OTHER||LS mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.58||0.687|TWO_SIDED|95.0|-0.91|1.38|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.38|-0.91|0.687
71002597|NCT00565812|141513074|SUPERIORITY_OR_OTHER||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.65||0.677|TWO_SIDED|95.0|-1.56|1.01|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.01|-1.56|0.677
71002598|NCT00565812|141513074|SUPERIORITY_OR_OTHER||LS mean difference|0.47|STANDARD_ERROR_OF_MEAN|0.65||0.469|TWO_SIDED|95.0|-0.8|1.74|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.74|-0.80|0.469
71002599|NCT00565812|141513075|SUPERIORITY_OR_OTHER||LS mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.48||0.632|TWO_SIDED|95.0|-0.71|1.17|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.17|-0.71|0.632
71002600|NCT00565812|141513075|SUPERIORITY_OR_OTHER||LS mean difference|0.49|STANDARD_ERROR_OF_MEAN|0.48||0.308|TWO_SIDED|95.0|-0.45|1.42|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.42|-0.45|0.308
71002601|NCT00565812|141513075|SUPERIORITY_OR_OTHER||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.54||0.615|TWO_SIDED|95.0|-1.33|0.79|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.79|-1.33|0.615
71002602|NCT00565812|141513075|SUPERIORITY_OR_OTHER||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.53||0.425|TWO_SIDED|95.0|-1.48|0.62|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.62|-1.48|0.425
71043037|NCT03396874|141594890|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Sensitivity|100.0|||<|1e-07|TWO_SIDED|95.0|97.85|100.0||p-value = 2.2e-16|Exact binomial proportion test|||Sensitivity, composite standard, bone: We determined the sensitivity of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy (composite standard of truth). In bone, the sensitivity of conventional imaging ranges between 30-50%. The null hypothesis is that the sensitivity at 50% will be tested against the alternative hypothesis that the sensitivity is greater than 50%.||100.00|97.85|<0.0000001
71043038|NCT00588731|141594894|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.90
71002603|NCT00565812|141513076|SUPERIORITY_OR_OTHER||LS mean difference|0.67|STANDARD_ERROR_OF_MEAN|0.54||0.214|TWO_SIDED|95.0|-0.39|1.72|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.72|-0.39|0.214
71002604|NCT00565812|141513076|SUPERIORITY_OR_OTHER||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.53||0.98|TWO_SIDED|95.0|-1.06|1.03|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.03|-1.06|0.980
71002605|NCT00565812|141513076|SUPERIORITY_OR_OTHER||LS mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.59||0.575|TWO_SIDED|95.0|-0.83|1.49|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.49|-0.83|0.575
71043039|NCT00588731|141594895|SUPERIORITY_OR_OTHER|||||||0.76|||||||ANOVA|||||||0.76
71043040|NCT02093923|141594933|SUPERIORITY||Percent Change in Mean Rate|-100.0|||<|0.0001|TWO_SIDED|95.0|-100.0|-100.0|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-100.00|-100.00|<.0001
71002606|NCT00565812|141513076|SUPERIORITY_OR_OTHER||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.59||0.986|TWO_SIDED|95.0|-1.16|1.14|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.14|-1.16|0.986
71002607|NCT00565812|141513077|SUPERIORITY_OR_OTHER||LS mean difference|1.33|STANDARD_ERROR_OF_MEAN|0.61||0.03|TWO_SIDED|95.0|0.13|2.52|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.52|0.13|0.030
71043041|NCT02093923|141594933|SUPERIORITY||Percent Change in Mean Rate|-87.77||||0.005|TWO_SIDED|95.0|-97.18|-46.9|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-46.90|-97.18|0.0050
71002608|NCT00565812|141513077|SUPERIORITY_OR_OTHER||LS mean difference|0.43|STANDARD_ERROR_OF_MEAN|0.6||0.48|TWO_SIDED|95.0|-0.76|1.61|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.61|-0.76|0.480
71002609|NCT00565812|141513077|SUPERIORITY_OR_OTHER||LS mean difference|1.01|STANDARD_ERROR_OF_MEAN|0.67||0.132|TWO_SIDED|95.0|-0.3|2.32|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.32|-0.30|0.132
71002610|NCT00565812|141513077|SUPERIORITY_OR_OTHER||LS mean difference|1.04|STANDARD_ERROR_OF_MEAN|0.66||0.117|TWO_SIDED|95.0|-0.26|2.34|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.34|-0.26|0.117
71043042|NCT02093923|141594933|SUPERIORITY||Percent Change in Mean Rate|-91.08||||0.0012||95.0|-97.93|-61.57|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-61.57|-97.93|0.0012
71043043|NCT02093923|141594934|SUPERIORITY||Percent Change in Mean Rate|-100.0|||<|0.0001|TWO_SIDED|95.0|-100.0|-100.0|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-100.00|-100.00|<.0001
71043044|NCT02093923|141594934|SUPERIORITY||Percent Change in Mean Rate|-84.08|||<|0.0001|TWO_SIDED|95.0|-93.07|-63.46|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-63.46|-93.07|<.0001
71043045|NCT02093923|141594934|SUPERIORITY||Percent Change in Mean Rate|-87.84|||<|0.0001|TWO_SIDED|95.0|-94.81|-71.5|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-71.50|-94.81|<.0001
71002611|NCT00565812|141513078|SUPERIORITY_OR_OTHER||LS mean difference|1.06|STANDARD_ERROR_OF_MEAN|0.71||0.133|TWO_SIDED|95.0|-0.32|2.44|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.44|-0.32|0.133
71002612|NCT00565812|141513078|SUPERIORITY_OR_OTHER||LS mean difference|0.44|STANDARD_ERROR_OF_MEAN|0.7||0.524|TWO_SIDED|95.0|-0.93|1.82|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.82|-0.93|0.524
70924519|NCT03892616|141341589|OTHER||Ratio of adjusted geometric means [%]|60.2|||||TWO_SIDED|90.0|55.3|65.5|||||The ratio was calculated as adjusted geometric mean of TF2a fasted (C) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.65|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||65.5|55.3|
70924520|NCT03892616|141341589|OTHER||Ratio of adjusted geometric means [%]|71.5|||||TWO_SIDED|90.0|65.6|78.0|||||The ratio was calculated as adjusted geometric mean of TF2b fasted (E) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.65|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||78.0|65.6|
70924521|NCT03892616|141341589|OTHER||Ratio of adjusted geometric means [%]|177.9|||||TWO_SIDED|90.0|162.8|194.3|||||The ratio was calculated as adjusted geometric mean of TF2a fed (B) as numerator and adjusted geometric mean of TF2a fasted (C) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.65|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||194.3|162.8|
70924522|NCT03892616|141341589|OTHER||Ratio of adjusted geometric means [%]|152.9|||||TWO_SIDED|90.0|139.5|167.7|||||The ratio was calculated as adjusted geometric mean of TF2b fed (D) as numerator and adjusted geometric mean of TF2b fasted (E) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.65|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||167.7|139.5|
70924523|NCT03892616|141341590|OTHER||Ratio of adjusted geometric means [%]|60.3|||||TWO_SIDED|90.0|55.4|65.7|||||The ratio was calculated as adjusted geometric mean of TF2a fasted (C) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.70|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||65.7|55.4|
70924524|NCT03892616|141341590|OTHER||Ratio of adjusted geometric means [%]|71.1|||||TWO_SIDED|90.0|65.2|77.6|||||The ratio was calculated as adjusted geometric mean of TF2b fasted (E) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.70|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||77.6|65.2|
71043046|NCT02093923|141594935|SUPERIORITY||Percent Change in Mean Rate|-100.0|||<|0.0001|TWO_SIDED|95.0|-100.0|-100.0|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-100.00|-100.00|<.0001
70924525|NCT03892616|141341590|OTHER||Ratio of adjusted geometric means [%]|175.8|||||TWO_SIDED|90.0|160.8|192.2|||||The ratio was calculated as adjusted geometric mean of TF2a fed (B) as numerator and adjusted geometric mean of TF2a fasted (C) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.70|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||192.2|160.8|
70924526|NCT03892616|141341590|OTHER||Ratio of adjusted geometric means [%]|150.2|||||TWO_SIDED|90.0|136.9|164.7|||||The ratio was calculated as adjusted geometric mean of TF2b fed (D) as numerator and adjusted geometric mean of TF2b fasted (E) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.70|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||164.7|136.9|
71002613|NCT00565812|141513078|SUPERIORITY_OR_OTHER||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.78||0.743|TWO_SIDED|95.0|-1.27|1.78|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.78|-1.27|0.743
71043047|NCT02093923|141594935|SUPERIORITY||Percent Change in Mean Rate|-82.38|||<|0.0001|TWO_SIDED|95.0|-92.5|-58.64|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-58.64|-92.50|<.0001
70924527|NCT03892616|141341591|OTHER||Ratio of adjusted geometric means [%]|56.5|||||TWO_SIDED|90.0|51.8|61.7|||||The ratio was calculated as adjusted geometric mean of TF2a fasted (C) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 13.02|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||61.7|51.8|
71043048|NCT02093923|141594935|SUPERIORITY||Percent Change in Mean Rate|-87.02|||<|0.0001|TWO_SIDED|95.0|-94.55|-69.06|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-69.06|-94.55|<.0001
71002614|NCT00565812|141513078|SUPERIORITY_OR_OTHER||LS mean difference|0.78|STANDARD_ERROR_OF_MEAN|0.77||0.31|TWO_SIDED|95.0|-0.73|2.3|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.30|-0.73|0.310
71002615|NCT00565812|141513079|SUPERIORITY_OR_OTHER||LS mean difference|1.17|STANDARD_ERROR_OF_MEAN|0.62||0.058|TWO_SIDED|95.0|-0.04|2.38|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.38|-0.04|0.058
71002616|NCT00565812|141513079|SUPERIORITY_OR_OTHER||LS mean difference|0.76|STANDARD_ERROR_OF_MEAN|0.61||0.213|TWO_SIDED|95.0|-0.44|1.96|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.96|-0.44|0.213
71002617|NCT00565812|141513079|SUPERIORITY_OR_OTHER||LS mean difference|0.98|STANDARD_ERROR_OF_MEAN|0.67||0.143|TWO_SIDED|95.0|-0.33|2.3|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.30|-0.33|0.143
71002618|NCT00565812|141513079|SUPERIORITY_OR_OTHER||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.67||0.45|TWO_SIDED|95.0|-0.8|1.81|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.81|-0.80|0.450
71002619|NCT00565812|141513080|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.51||0.701|TWO_SIDED|95.0|-1.19|0.8|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.80|-1.19|0.701
71002620|NCT00565812|141513080|SUPERIORITY_OR_OTHER||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.5||0.764|TWO_SIDED|95.0|-0.84|1.14|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.14|-0.84|0.764
71002621|NCT00565812|141513080|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.57||0.228|TWO_SIDED|95.0|-1.8|0.43|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.43|-1.80|0.228
71002622|NCT00565812|141513080|SUPERIORITY_OR_OTHER||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.56||0.514|TWO_SIDED|95.0|-1.47|0.74|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.74|-1.47|0.514
71002623|NCT00565812|141513081|SUPERIORITY_OR_OTHER||LS mean difference|1.42|STANDARD_ERROR_OF_MEAN|0.62||0.023|TWO_SIDED|95.0|0.19|2.65|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.65|0.19|0.023
71002624|NCT00565812|141513081|SUPERIORITY_OR_OTHER||LS mean difference|0.53|STANDARD_ERROR_OF_MEAN|0.62||0.391|TWO_SIDED|95.0|-0.68|1.75|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.75|-0.68|0.391
71002625|NCT00565812|141513081|SUPERIORITY_OR_OTHER||LS mean difference|1.02|STANDARD_ERROR_OF_MEAN|0.69||0.142|TWO_SIDED|95.0|-0.34|2.37|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.37|-0.34|0.142
71002626|NCT00565812|141513081|SUPERIORITY_OR_OTHER||LS mean difference|0.87|STANDARD_ERROR_OF_MEAN|0.68||0.204|TWO_SIDED|95.0|-0.47|2.21|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.21|-0.47|0.204
71002627|NCT00565812|141513088|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.952||||0.875|TWO_SIDED|95.0|0.516|1.756|||Regression, Logistic|||Month 12; Odds ratio (OR), 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.756|0.516|0.875
71002628|NCT00565812|141513088|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.273||||0.406|TWO_SIDED|95.0|0.721|2.247|||Regression, Logistic|||Month 12; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||2.247|0.721|0.406
71002629|NCT00565812|141513088|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.787||||0.406|TWO_SIDED|95.0|0.448|1.384|||Regression, Logistic|||Month 24; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.384|0.448|0.406
71002630|NCT00565812|141513088|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.154||||0.591|TWO_SIDED|95.0|0.685|1.942|||Regression, Logistic|||Month 24; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.942|0.685|0.591
71002631|NCT00565812|141513089|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.704||||0.168|TWO_SIDED|95.0|0.428|1.16|||Regression, Logistic|||Month 12; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.160|0.428|0.168
71002632|NCT00565812|141513089|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.893||||0.634|TWO_SIDED|95.0|0.56|1.423|||Regression, Logistic|||Month 12; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.423|0.560|0.634
71043049|NCT02093923|141594936|SUPERIORITY||Percent Change in Mean Rate|-100.0|||<|0.0001|TWO_SIDED|95.0|-100.0|-100.0|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-100.00|-100.00|<.0001
71043050|NCT02093923|141594936|SUPERIORITY||Percent Change in Mean Rate|-85.24||||0.0141||95.0|-96.79|-32.03|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-32.03|-96.79|0.0141
71043051|NCT02093923|141594936|SUPERIORITY||Percent Change in Mean Rate|-89.35||||0.004|TWO_SIDED|95.0|-97.68|-51.13|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-51.13|-97.68|0.0040
71002633|NCT00565812|141513089|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.583||||0.032|TWO_SIDED|95.0|0.356|0.955|||Regression, Logistic|||Month 24; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||0.955|0.356|0.032
71002634|NCT00565812|141513089|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.774||||0.276|TWO_SIDED|95.0|0.489|1.227|||Regression, Logistic|||Month 24; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.227|0.489|0.276
71002635|NCT00565812|141513090|SUPERIORITY_OR_OTHER||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.09||0.709|TWO_SIDED|95.0|-0.21|0.14|||ANCOVA|||LS Mean, 95 percent CI and P-values were obtained from an analysis of covariance (ANCOVA) model, with treatment group, (collapsed) KLG, geographic region, and gender as factors and age and body mass index as covariates.||0.14|-0.21|0.709
71002636|NCT00565812|141513090|SUPERIORITY_OR_OTHER||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.09||0.798|TWO_SIDED|95.0|-0.15|0.2|||ANCOVA|||LS-Mean, 95 percent CI and P-values were obtained from an ANCOVA model, with treatment group, (collapsed) KLG, geographic region, and gender as factors and age and body mass index as covariates.||0.20|-0.15|0.798
71002637|NCT00565812|141513091|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.032||||0.81|TWO_SIDED|95.0|0.797|1.337|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, baseline JSW, age and body mass index as covariates.||1.337|0.797|0.810
71002638|NCT00565812|141513091|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.068||||0.62|TWO_SIDED|95.0|0.824|1.383|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, baseline JSW, age and body mass index as covariates.||1.383|0.824|0.620
71002639|NCT00565812|141513092|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.745||||0.047|TWO_SIDED|95.0|0.557|0.997|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||0.997|0.557|0.047
71002640|NCT00565812|141513092|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.864||||0.317|TWO_SIDED|95.0|0.65|1.15|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.150|0.650|0.317
71043052|NCT00248170|141594940|SUPERIORITY_OR_OTHER|||||||0.315|||||||Log Rank|||||||0.3150
71043053|NCT01557582|141594948|SUPERIORITY_OR_OTHER||EDV percent difference|4.8|||||TWO_SIDED|95.0|2.24|7.56|||||Mean percent difference and 95% CI for EDV|||7.56|2.24|
71002641|NCT00565812|141513093|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.043||||0.881|TWO_SIDED|95.0|0.602|1.806|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.806|0.602|0.881
71002642|NCT00565812|141513093|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.186||||0.525|TWO_SIDED|95.0|0.701|2.009|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||2.009|0.701|0.525
71002643|NCT00565812|141513097|SUPERIORITY_OR_OTHER||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.63||0.668|TWO_SIDED|95.0|-1.5|0.96|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.96|-1.50|0.668
71002644|NCT00565812|141513097|SUPERIORITY_OR_OTHER||LS mean difference|0.62|STANDARD_ERROR_OF_MEAN|0.63||0.326|TWO_SIDED|95.0|-0.61|1.85|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.85|-0.61|0.326
71002645|NCT00565812|141513097|SUPERIORITY_OR_OTHER||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.66||0.679|TWO_SIDED|95.0|-1.56|1.01|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.01|-1.56|0.679
71002646|NCT00565812|141513097|SUPERIORITY_OR_OTHER||LS mean difference|1.86|STANDARD_ERROR_OF_MEAN|0.66||0.005|TWO_SIDED|95.0|0.57|3.14|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.14|0.57|0.005
71002647|NCT00565812|141513097|SUPERIORITY_OR_OTHER||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.72||0.399|TWO_SIDED|95.0|-0.8|2.01|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.01|-0.80|0.399
71002648|NCT00565812|141513097|SUPERIORITY_OR_OTHER||LS mean difference|2.52|STANDARD_ERROR_OF_MEAN|0.71|<|0.001|TWO_SIDED|95.0|1.12|3.92|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.92|1.12|<0.001
71002649|NCT00565812|141513097|SUPERIORITY_OR_OTHER||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.7||0.668|TWO_SIDED|95.0|-1.08|1.68|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.68|-1.08|0.668
71002650|NCT00565812|141513097|SUPERIORITY_OR_OTHER||LS mean difference|1.76|STANDARD_ERROR_OF_MEAN|0.7||0.012|TWO_SIDED|95.0|0.39|3.13|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.13|0.39|0.012
71002651|NCT00565812|141513097|SUPERIORITY_OR_OTHER||LS mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.75||0.109|TWO_SIDED|95.0|-0.27|2.67|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group x visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.67|-0.27|0.109
71043054|NCT01557582|141594948|SUPERIORITY_OR_OTHER||ESV percent difference|1.76|||||TWO_SIDED|95.0|-1.17|4.76|||||Mean percent difference and 95% CI for ESV|||4.76|-1.17|
71043055|NCT01557582|141594948|SUPERIORITY_OR_OTHER||EF percent difference|2.03|||||TWO_SIDED|95.0|0.72|3.33|||||Mean percent difference and 95% CI for EF|||3.33|0.72|
71043056|NCT02413294|141594972|SUPERIORITY|||||||0.37||||||This t-test analyzes the change in mean between the midpoint interview immediately prior to the start of the intervention and the follow-up interview at the conclusion of the intervention.|Paired T test, 2-sided|||The analysis, like the measures themselves, tracks the significance of the change from end of pre-intervention period to end of intervention period, so while only a single comparison group is listed, because it is all one population group, there are two sets of data for that group.||||0.37
71043057|NCT02413294|141594973|SUPERIORITY|||||||0.42|||||||Paired T test, 2-sided|||The analysis, like the measures themselves, tracks the significance of the change from end of pre-intervention period to end of intervention period, so while only a single comparison group is listed, because it is all one population group, there are two sets of data for that group.||||0.42
71043058|NCT02413294|141594974|SUPERIORITY|||||||0.65|||||||Paired T test, 2-sided|||The analysis, like the measures themselves, tracks the significance of the change from end of pre-intervention period to end of intervention period, so while only a single comparison group is listed, because it is all one population group, there are two sets of data for that group.||||0.65
71043059|NCT02413294|141594975|SUPERIORITY|||||||1|||||||Fisher Exact|||The analysis, like the measures themselves, tracks the significance of the change from end of pre-intervention period to end of intervention period, so while only a single comparison group is listed, because it is all one population group, there are two sets of data for that group.||||1.0
71002652|NCT00565812|141513097|SUPERIORITY_OR_OTHER||LS mean difference|1.03|STANDARD_ERROR_OF_MEAN|0.74||0.163|TWO_SIDED|95.0|-0.42|2.48|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.48|-0.42|0.163
71002653|NCT00565812|141513097|SUPERIORITY_OR_OTHER||LS mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.73||0.424|TWO_SIDED|95.0|-2.02|0.85|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.85|-2.02|0.424
71002654|NCT00565812|141513097|SUPERIORITY_OR_OTHER||LS mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.72||0.635|TWO_SIDED|95.0|-1.07|1.76|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.76|-1.07|0.635
71002655|NCT00565812|141513097|SUPERIORITY_OR_OTHER||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.75||0.855|TWO_SIDED|95.0|-1.34|1.61|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.61|-1.34|0.855
71002656|NCT00565812|141513097|SUPERIORITY_OR_OTHER||LS mean difference|1.84|STANDARD_ERROR_OF_MEAN|0.74||0.013|TWO_SIDED|95.0|0.38|3.3|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.30|0.38|0.013
71002657|NCT00565812|141513097|SUPERIORITY_OR_OTHER||LS mean difference|-0.85|STANDARD_ERROR_OF_MEAN|0.81||0.292|TWO_SIDED|95.0|-2.44|0.73|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.73|-2.44|0.292
71002658|NCT00565812|141513097|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.8||0.897|TWO_SIDED|95.0|-1.47|1.68|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.68|-1.47|0.897
71002659|NCT00565812|141513097|SUPERIORITY_OR_OTHER||LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.84||0.39|TWO_SIDED|95.0|-2.36|0.92|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.92|-2.36|0.390
71002660|NCT00565812|141513097|SUPERIORITY_OR_OTHER||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.83||0.659|TWO_SIDED|95.0|-1.26|1.99|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.99|-1.26|0.659
71002661|NCT00565812|141513097|SUPERIORITY_OR_OTHER||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.8||0.847|TWO_SIDED|95.0|-1.73|1.42|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.42|-1.73|0.847
71043060|NCT02413294|141594976|SUPERIORITY|||||||0.65|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.65
71043061|NCT02413294|141594977|SUPERIORITY|||||||0.65|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.65
71043062|NCT02413294|141594978|SUPERIORITY|||||||0.94|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.94
71100885|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with vulvar dermatosis and positive AWR?||||||0.0927|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with vulvar dermatosis and positive AWR.||||0.0927
71043063|NCT02413294|141594979|SUPERIORITY|||||||0.81|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.81
71100886|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with vulvar dermatosis and positive AWR?||||||0.036|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with vulvar dermatosis and positive AWR.||||0.0360
71100887|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with vulvodynia and positive AWR?||||||0.072|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with vulvodynia and positive AWR.||||0.0720
71100888|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with vulvodynia and positive AWR?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with vulvodynia and positive AWR.||||1.0000
71002662|NCT00565812|141513097|SUPERIORITY_OR_OTHER||LS mean difference|0.77|STANDARD_ERROR_OF_MEAN|0.8||0.333|TWO_SIDED|95.0|-0.79|2.34|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.34|-0.79|0.333
71002663|NCT00565812|141513098|SUPERIORITY_OR_OTHER||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.42||0.238|TWO_SIDED|95.0|-1.31|0.32|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.32|-1.31|0.238
71002664|NCT00565812|141513098|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.41||0.815|TWO_SIDED|95.0|-0.72|0.91|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.91|-0.72|0.815
71002665|NCT00565812|141513098|SUPERIORITY_OR_OTHER||LS mean difference|0.28|STANDARD_ERROR_OF_MEAN|0.42||0.508|TWO_SIDED|95.0|-0.54|1.1|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.10|-0.54|0.508
71002666|NCT00565812|141513098|SUPERIORITY_OR_OTHER||LS mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.42||0.004|TWO_SIDED|95.0|0.38|2.02|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.02|0.38|0.004
71002667|NCT00565812|141513098|SUPERIORITY_OR_OTHER||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.45||0.683|TWO_SIDED|95.0|-1.07|0.7|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.70|-1.07|0.683
71002668|NCT00565812|141513098|SUPERIORITY_OR_OTHER||LS mean difference|1.21|STANDARD_ERROR_OF_MEAN|0.45||0.007|TWO_SIDED|95.0|0.33|2.09|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.09|0.33|0.007
71002669|NCT00565812|141513098|SUPERIORITY_OR_OTHER||LS mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.45||0.687|TWO_SIDED|95.0|-0.71|1.07|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.07|-0.71|0.687
71002670|NCT00565812|141513098|SUPERIORITY_OR_OTHER||LS mean difference|0.89|STANDARD_ERROR_OF_MEAN|0.45||0.05|TWO_SIDED|95.0|0.0|1.78|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.78|-0.00|0.050
71002671|NCT00565812|141513098|SUPERIORITY_OR_OTHER||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.48||0.215|TWO_SIDED|95.0|-0.35|1.54|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.54|-0.35|0.215
71002672|NCT00565812|141513098|SUPERIORITY_OR_OTHER||LS mean difference|0.96|STANDARD_ERROR_OF_MEAN|0.47||0.042|TWO_SIDED|95.0|0.03|1.89|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.89|0.03|0.042
71002673|NCT00565812|141513098|SUPERIORITY_OR_OTHER||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.5||0.401|TWO_SIDED|95.0|-1.41|0.56|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.56|-1.41|0.401
71002674|NCT00565812|141513098|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.5||0.98|TWO_SIDED|95.0|-0.96|0.99|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.99|-0.96|0.980
71002675|NCT00565812|141513098|SUPERIORITY_OR_OTHER||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.51||0.632|TWO_SIDED|95.0|-1.25|0.76|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.76|-1.25|0.632
71043064|NCT02413294|141594980|SUPERIORITY|||||||0.4|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.40
71043065|NCT02413294|141594981|SUPERIORITY|||||||0.46|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.46
70924528|NCT03892616|141341591|OTHER||Ratio of adjusted geometric means [%]|70.5|||||TWO_SIDED|90.0|64.4|77.1|||||The ratio was calculated as adjusted geometric mean of TF2b fasted (E) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 13.02|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||77.1|64.4|
70924529|NCT03892616|141341591|OTHER||Ratio of adjusted geometric means [%]|185.3|||||TWO_SIDED|90.0|169.4|202.8|||||The ratio was calculated as adjusted geometric mean of TF2a fed (B) as numerator and adjusted geometric mean of TF2a fasted (C) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 13.02|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||202.8|169.4|
71100889|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with vulvodynia and positive AWR?||||||0.4833|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with vulvodynia and positive AWR.||||0.4833
71100890|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with vulvodynia and positive AWR?||||||0.3594|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with vulvodynia and positive AWR.||||0.3594
71100891|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with vulvodynia and positive AWR?||||||0.5987|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with vulvodynia and positive AWR.||||0.5987
71100892|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with vulvodynia and positive AWR?||||||0.4164|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with vulvodynia and positive AWR.||||0.4164
71100893|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with vulvodynia and positive AWR?||||||0.072|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with vulvodynia and positive AWR.||||0.0720
71100894|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with vulvodynia and positive AWR?||||||0.0148|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with vulvodynia and positive AWR.||||0.0148
71100895|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with vulvodynia and positive AWR?||||||0.0085|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with vulvodynia and positive AWR.||||0.0085
71100896|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with vulvodynia and positive AWR?||||||0.1918|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with vulvodynia and positive AWR.||||0.1918
71100897|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's line versus Vestibule in patients with vulvodynia and positive AWR?||||||0.3037|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's line versus Vestibule in patients with vulvodynia and positive AWR.||||0.3037
71100898|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Sulcus versus Urethral Meatus in patients with vulvodynia and positive AWR?||||||0.4833|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Sulcus versus Urethral Meatus in patients with vulvodynia and positive AWR.||||0.4833
71100899|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Sulcus versus Hymenal Remnants in patients with vulvodynia and positive AWR?||||||0.3594|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Sulcus versus Hymenal Remnants in patients with vulvodynia and positive AWR.||||0.3594
71100900|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Hymenal Remnants versus Vestibule in patients with vulvodynia and positive AWR?||||||0.0877|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Hymenal Remnants versus Vestibule in patients with vulvodynia and positive AWR.||||0.0877
71100901|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with vulvodynia and positive AWR?||||||0.7726|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with vulvodynia and positive AWR.||||0.7726
71100902|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with impaired vulvar skin and positive AWR?||||||0.0191|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with impaired vulvar skin and positive AWR.||||0.0191
71002676|NCT00565812|141513098|SUPERIORITY_OR_OTHER||LS mean difference|1.08|STANDARD_ERROR_OF_MEAN|0.51||0.032|TWO_SIDED|95.0|0.09|2.07|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.07|0.09|0.032
71043066|NCT02413294|141594982|SUPERIORITY||||||<|0.01|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||<0.01
71002677|NCT00565812|141513098|SUPERIORITY_OR_OTHER||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.54||0.668|TWO_SIDED|95.0|-1.29|0.83|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.83|-1.29|0.668
71002678|NCT00565812|141513098|SUPERIORITY_OR_OTHER||LS mean difference|1.11|STANDARD_ERROR_OF_MEAN|0.54||0.038|TWO_SIDED|95.0|0.06|2.16|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.16|0.06|0.038
71002679|NCT00565812|141513098|SUPERIORITY_OR_OTHER||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.53||0.868|TWO_SIDED|95.0|-1.13|0.95|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.95|-1.13|0.868
71002680|NCT00565812|141513098|SUPERIORITY_OR_OTHER||LS mean difference|0.59|STANDARD_ERROR_OF_MEAN|0.52||0.257|TWO_SIDED|95.0|-0.43|1.62|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.62|-0.43|0.257
71002681|NCT00565812|141513098|SUPERIORITY_OR_OTHER||LS mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.55||0.895|TWO_SIDED|95.0|-1.0|1.15|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.15|-1.00|0.895
71002682|NCT00565812|141513098|SUPERIORITY_OR_OTHER||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.54||0.268|TWO_SIDED|95.0|-0.46|1.67|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.67|-0.46|0.268
71002683|NCT00565812|141513099|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.44||0.908|TWO_SIDED|95.0|-0.92|0.82|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.82|-0.92|0.908
71002684|NCT00565812|141513099|SUPERIORITY_OR_OTHER||LS mean difference|-1.18|STANDARD_ERROR_OF_MEAN|0.44||0.008|TWO_SIDED|95.0|-2.05|-0.31|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.31|-2.05|0.008
71002685|NCT00565812|141513099|SUPERIORITY_OR_OTHER||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.46||0.44|TWO_SIDED|95.0|-1.25|0.54|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.54|-1.25|0.440
71002686|NCT00565812|141513099|SUPERIORITY_OR_OTHER||LS mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.46||0.14|TWO_SIDED|95.0|-1.57|0.22|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.22|-1.57|0.140
71002687|NCT00565812|141513099|SUPERIORITY_OR_OTHER||LS mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.46||0.474|TWO_SIDED|95.0|-0.58|1.24|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.24|-0.58|0.474
71002688|NCT00565812|141513099|SUPERIORITY_OR_OTHER||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.46||0.376|TWO_SIDED|95.0|-1.32|0.5|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.50|-1.32|0.376
71002689|NCT00565812|141513099|SUPERIORITY_OR_OTHER||LS mean difference|0.66|STANDARD_ERROR_OF_MEAN|0.5||0.186|TWO_SIDED|95.0|-0.32|1.64|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.64|-0.32|0.186
71043067|NCT02413294|141594983|SUPERIORITY|||||||0.28|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.28
71043068|NCT02413294|141594984|SUPERIORITY|||||||0.67|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.67
71100903|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with impaired vulvar skin and positive AWR?||||||0.0287|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with impaired vulvar skin and positive AWR.||||0.0287
71002690|NCT00565812|141513099|SUPERIORITY_OR_OTHER||LS mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.5||0.185|TWO_SIDED|95.0|-1.63|0.32|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.32|-1.63|0.185
71002691|NCT00565812|141513099|SUPERIORITY_OR_OTHER||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.52||0.334|TWO_SIDED|95.0|-1.53|0.52|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.52|-1.53|0.334
71002692|NCT00565812|141513099|SUPERIORITY_OR_OTHER||LS mean difference|-0.99|STANDARD_ERROR_OF_MEAN|0.52||0.055|TWO_SIDED|95.0|-2.0|0.02|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.02|-2.00|0.055
71002693|NCT00565812|141513099|SUPERIORITY_OR_OTHER||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.54||0.539|TWO_SIDED|95.0|-1.38|0.72|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.72|-1.38|0.539
71002694|NCT00565812|141513099|SUPERIORITY_OR_OTHER||LS mean difference|-1.26|STANDARD_ERROR_OF_MEAN|0.53||0.018|TWO_SIDED|95.0|-2.3|-0.22|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.22|-2.30|0.018
71002695|NCT00565812|141513099|SUPERIORITY_OR_OTHER||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.53||0.365|TWO_SIDED|95.0|-1.52|0.56|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.56|-1.52|0.365
71002696|NCT00565812|141513099|SUPERIORITY_OR_OTHER||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.52||0.403|TWO_SIDED|95.0|-1.47|0.59|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.59|-1.47|0.403
71002697|NCT00565812|141513099|SUPERIORITY_OR_OTHER||LS mean difference|-1.32|STANDARD_ERROR_OF_MEAN|0.57||0.02|TWO_SIDED|95.0|-2.43|-0.21|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.21|-2.43|0.020
71002698|NCT00565812|141513099|SUPERIORITY_OR_OTHER||LS mean difference|-1.87|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|-2.98|-0.77|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.77|-2.98|<0.001
71043069|NCT02413294|141594985|SUPERIORITY|||||||0.56|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.56
71043070|NCT02413294|141594986|SUPERIORITY|||||||0.82|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.82
71043071|NCT01631682|141594987|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||This study used a within-groups design. Each subject provides his/her own comparison data. It was predicted that that a conditioned stimulus that was reactivated (CS+R) after propranolol was administered would result in a smaller SCR than a conditioned stimulus that was not reactivated (CS+N).||||>.05
71100904|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with impaired vulvar skin and positive AWR?||||||0.6374|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with impaired vulvar skin and positive AWR.||||0.6374
71100905|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR?||||||0.7512|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR.||||0.7512
70924530|NCT03892616|141341591|OTHER||Ratio of adjusted geometric means [%]|158.4|||||TWO_SIDED|90.0|144.3|173.9|||||The ratio was calculated as adjusted geometric mean of TF2b fed (D) as numerator and adjusted geometric mean of TF2b fasted (E) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 13.02|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||173.9|144.3|
70924531|NCT03562377|141341619|NON_INFERIORITY|The difference in response rates was calculated using the Mantel-Haenszel estimate of the risk difference stratified by baseline disease severity together with the 2-sided 95% CI. Non-inferiority of tralokinumab was demonstrated if the lower limit of the 95% CI was greater than -25%. Power calculation assumed 160 subjects in the per protocol analysis set, providing 98% power to establish non-inferiority, assuming response rates of 80% in both treatment groups and a non-inferiority margin of -25%|Risk Difference (RD)|-4.1|||||TWO_SIDED|95.0|-11.3|3.1|||Mantel Haenszel|||||3.1|-11.3|
70924532|NCT03562377|141341620|NON_INFERIORITY|The difference in response rates was calculated using the Mantel-Haenszel estimate of the risk difference stratified by baseline disease severity together with the 2-sided 95% CI. Non-inferiority of tralokinumab was demonstrated if the lower limit of the 95% CI was greater than -25%. Power calculation assumed 160 subjects in the per protocol analysis set, providing 98% power to establish non-inferiority, assuming response rates of 80% in both treatment groups and a non-inferiority margin of -25%|Risk Difference (RD)|1.8|||||TWO_SIDED|95.0|-9.2|12.8|||Mantel Haenszel|||||12.8|-9.2|
70924533|NCT03562377|141341621|SUPERIORITY||Risk Difference (RD)|11.4||||0.049|TWO_SIDED|95.0|0.2|22.6||The p-value was adjusted for multiplicity by a pre-specified testing hierarchy. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders in the primary analysis of the primary estimand.|Cochran-Mantel-Haenszel|The difference in response rates was analysed using the Cochran-Mantel-Haenszel test stratified by baseline disease severity (moderate or severe).||||22.6|0.2|0.049
71002699|NCT00565812|141513099|SUPERIORITY_OR_OTHER||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.54||0.269|TWO_SIDED|95.0|-1.66|0.46|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.46|-1.66|0.269
71002700|NCT00565812|141513099|SUPERIORITY_OR_OTHER||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.54||0.104|TWO_SIDED|95.0|-1.92|0.18|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.18|-1.92|0.104
71002701|NCT00565812|141513099|SUPERIORITY_OR_OTHER||LS mean difference|-1.18|STANDARD_ERROR_OF_MEAN|0.57||0.038|TWO_SIDED|95.0|-2.3|-0.06|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.06|-2.30|0.038
71002702|NCT00565812|141513099|SUPERIORITY_OR_OTHER||LS mean difference|-1.16|STANDARD_ERROR_OF_MEAN|0.57||0.041|TWO_SIDED|95.0|-2.28|-0.05|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.05|-2.28|0.041
71002703|NCT02033850|141513107|SUPERIORITY|||||||0.145|||||||t-test, 2 sided|||Δs on ADL (baseline vs 6 months)||||.145
71002704|NCT02033850|141513107|SUPERIORITY|||||||0.618|||||||t-test, 2 sided|||Δs on ADL (6 vs 12 months)||||.618
71002705|NCT02033850|141513107|SUPERIORITY|||||||0.262|||||||t-test, 2 sided|||Δs on ADL (baseline vs 12 months)||||.262
71002706|NCT02033850|141513107|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||Δs on IADL (baseline vs 6 months)||||.240
71002707|NCT02033850|141513107|SUPERIORITY|||||||0.134|||||||t-test, 2 sided|||Δs on IADL (6 vs 12 months)||||.134
71002708|NCT02033850|141513107|SUPERIORITY|||||||0.457|||||||t-test, 2 sided|||Δs on IADL (baseline vs 12 months)||||.457
71002709|NCT02033850|141513107|SUPERIORITY|||||||0.612|||||||t-test, 2 sided|||Δs on DAD (baseline vs 6 months)||||.612
71043072|NCT01631682|141594987|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||This study used a within-groups design. Each subject provides his/her own comparison data. It was predicted that that a conditioned stimulus that was initially presented (CS+R) and then followed by a series of extinction trials after a 10-min delay would result in a smaller SCR than a conditioned stimulus (CS+N) that was not extinguished without a 10-min delay.||||>.05
71043073|NCT01631682|141594987|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||This study used a within-groups design. Each subject provides his/her own comparison data. It was predicted that that a conditioned stimulus that was reactivated (CS+R) after mifepristone was administered would result in a smaller SCR than a conditioned stimulus that was not reactivated (CS+N).||||<.05
71043074|NCT01631682|141594987|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||This study used a within-groups design. Each subject provides his/her own comparison data. It was predicted that that a conditioned stimulus that was reactivated (CS+R) after intranasal oxytocin was administered would result in a smaller SCR than a conditioned stimulus that was not reactivated (CS+N).||||>.05
71043075|NCT06442410|141595017|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71043076|NCT06442410|141595018|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71043077|NCT06442410|141595019|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71043078|NCT06442410|141595020|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71043079|NCT06442410|141595021|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71043080|NCT06442410|141595022|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71100906|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with impaired vulvar skin and positive AWR?||||||0.2734|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with impaired vulvar skin and positive AWR.||||0.2734
71002710|NCT02033850|141513107|SUPERIORITY|||||||0.522|||||||t-test, 2 sided|||Δs on DAD (6 vs 12 months)||||.522
71002711|NCT02033850|141513107|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||Δs on DAD (baseline vs 12 months)||||.800
71002712|NCT02033850|141513108|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||Δs on AQ (baseline vs 6 months)||||.204
71002713|NCT02033850|141513108|SUPERIORITY|||||||0.81|||||||t-test, 2 sided|||Δs on AQ (6 vs 12 months)||||.810
71002714|NCT02033850|141513108|SUPERIORITY|||||||0.193|||||||t-test, 2 sided|||Δs on AQ (baseline vs 12 months)||||.193
71002715|NCT02033850|141513108|SUPERIORITY|||||||0.698|||||||t-test, 2 sided|||Δs on EQ index (baseline vs 6 months)||||.698
71002716|NCT02033850|141513108|SUPERIORITY|||||||0.283|||||||t-test, 2 sided|||Δs on EQ index (6 vs 12 months)||||.283
71002717|NCT02033850|141513108|SUPERIORITY|||||||0.647|||||||t-test, 2 sided|||Δs on EQ index (baseline vs 12 months)||||.647
71002718|NCT02033850|141513108|SUPERIORITY|||||||0.057|||||||t-test, 2 sided|||Δs on EQ visual (baseline vs 6 months)||||.057
71002719|NCT02033850|141513108|SUPERIORITY|||||||0.685|||||||t-test, 2 sided|||Δs on EQ visual (6 vs 12 months)||||.685
71002720|NCT02033850|141513108|SUPERIORITY|||||||0.056|||||||t-test, 2 sided|||Δs on EQ visual (baseline vs 12 months)||||.056
71002721|NCT02033850|141513108|SUPERIORITY|||||||0.393|||||||t-test, 2 sided|||Δs on GDS (baseline vs 6 months)||||.393
71002722|NCT02033850|141513108|SUPERIORITY|||||||0.958|||||||t-test, 2 sided|||Δs on GDS (6 vs 12 months)||||.958
71002723|NCT02033850|141513108|SUPERIORITY|||||||0.448|||||||t-test, 2 sided|||Δs on GDS (baseline vs 12 months)||||.448
71002724|NCT02033850|141513108|SUPERIORITY|||||||0.567|||||||t-test, 2 sided|||Δs on MCS (baseline vs 6 months)||||.567
71002725|NCT02033850|141513108|SUPERIORITY|||||||0.274|||||||t-test, 2 sided|||Δs on MCS (6 vs 12 months)||||.274
71002726|NCT02033850|141513108|SUPERIORITY|||||||0.668|||||||t-test, 2 sided|||Δs on MCS (baseline vs 12 months)||||.668
71002727|NCT02033850|141513108|SUPERIORITY|||||||0.709|||||||t-test, 2 sided|||Δs on PCS (baseline vs 6 months)||||.709
71002728|NCT02033850|141513108|SUPERIORITY|||||||0.567|||||||t-test, 2 sided|||Δs on PCS (6 vs 12 months)||||.567
71002729|NCT02033850|141513108|SUPERIORITY|||||||0.867|||||||t-test, 2 sided|||Δs on PCS (baseline vs 12 months)||||.867
71002730|NCT02033850|141513109|SUPERIORITY|||||||0.095|||||||Chi-squared|||MCS outcome (baseline vs 6 months)||||.095
71002731|NCT02033850|141513109|SUPERIORITY|||||||0.729|||||||Chi-squared|||MCS outcome (6 vs 12 months)||||.729
71002732|NCT02033850|141513109|SUPERIORITY|||||||0.115|||||||Chi-squared|||MCS outcome (baseline vs 12 months)||||.115
71002733|NCT02033850|141513109|SUPERIORITY|||||||0.576|||||||Chi-squared|||PCS outcome (baseline vs 6 months)||||.576
71002734|NCT02033850|141513109|SUPERIORITY|||||||0.191|||||||Chi-squared|||PCS outcome (6 vs 12 months)||||.191
71002735|NCT02033850|141513109|SUPERIORITY|||||||0.79|||||||Chi-squared|||PCS outcome (baseline vs 12 months)||||.790
71002736|NCT02033850|141513110|SUPERIORITY|||||||0.936|||||||t-test, 2 sided|||Δs on MoCA (baseline vs 6 months)||||.936
71002737|NCT02033850|141513110|SUPERIORITY|||||||0.188|||||||t-test, 2 sided|||Δs on MoCA (6 vs 12 months)||||.188
71002738|NCT02033850|141513110|SUPERIORITY|||||||0.381|||||||t-test, 2 sided|||Δs on MoCA (baseline vs 12 months)||||.381
71002739|NCT02033850|141513110|SUPERIORITY|||||||0.458|||||||t-test, 2 sided|||Δs on MMSE (baseline vs 6 months)||||.458
71002740|NCT02033850|141513110|SUPERIORITY|||||||0.236|||||||t-test, 2 sided|||Δs on MMSE (6 vs 12 months)||||.236
71002741|NCT02033850|141513110|SUPERIORITY|||||||0.601|||||||t-test, 2 sided|||Δs on MMSE (baseline vs 12 months)||||.601
71002742|NCT02033850|141513110|SUPERIORITY|||||||0.839|||||||t-test, 2 sided|||Δs on RAVL immediate (baseline vs 6 months)||||.839
71002743|NCT02033850|141513110|SUPERIORITY|||||||0.021|||||||t-test, 2 sided|||Δs on RAVL immediate (6 vs 12 months)||||.021
71002744|NCT02033850|141513110|SUPERIORITY|||||||0.032|||||||t-test, 2 sided|||Δs on RAVL immediate (baseline vs 12 months)||||.032
71002745|NCT02033850|141513110|SUPERIORITY|||||||0.858|||||||t-test, 2 sided|||Δs on RAVL recall (baseline vs 6 months)||||.858
71002746|NCT02033850|141513110|SUPERIORITY|||||||0.212|||||||t-test, 2 sided|||Δs on RAVL recall (6 vs 12 months)||||.212
71002747|NCT02033850|141513110|SUPERIORITY|||||||0.268|||||||t-test, 2 sided|||Δs on RAVL recall (baseline vs 12 months)||||.268
71002748|NCT02033850|141513110|SUPERIORITY|||||||0.184|||||||t-test, 2 sided|||Δs on ROCF recall (baseline vs 6 months)||||.184
71002749|NCT02033850|141513110|SUPERIORITY|||||||0.358|||||||t-test, 2 sided|||Δs on ROCF recall (6 vs 12 months)||||.358
71002750|NCT02033850|141513110|SUPERIORITY|||||||0.768|||||||t-test, 2 sided|||Δs on ROCF recall (baseline vs 12 months)||||.768
71002751|NCT02033850|141513110|SUPERIORITY|||||||0.164|||||||t-test, 2 sided|||Δs on short story (baseline vs 6 months)||||.164
71002752|NCT02033850|141513110|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||Δs on short story (6 vs 12 months)||||.420
71002753|NCT02033850|141513110|SUPERIORITY|||||||0.527|||||||t-test, 2 sided|||Δs on short story (baseline vs 12 months)||||.527
71002754|NCT02033850|141513110|SUPERIORITY|||||||0.762|||||||t-test, 2 sided|||Δs on visual search (baseline vs 6 months)||||.762
71002755|NCT02033850|141513110|SUPERIORITY|||||||0.405|||||||t-test, 2 sided|||Δs on visual search (6 vs 12 months)||||.405
71002756|NCT02033850|141513110|SUPERIORITY|||||||0.674|||||||t-test, 2 sided|||Δs on visual search (baseline vs 12 months)||||.674
71002757|NCT02033850|141513110|SUPERIORITY|||||||0.328|||||||t-test, 2 sided|||Δs on SDMT (baseline vs 6 months)||||.328
71002758|NCT02033850|141513110|SUPERIORITY|||||||0.198|||||||t-test, 2 sided|||Δs on SDMT (6 vs 12 months)||||.198
71100907|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with impaired vulvar skin and positive AWR?||||||0.0287|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with impaired vulvar skin and positive AWR.||||0.0287
71002759|NCT02033850|141513110|SUPERIORITY|||||||0.639|||||||t-test, 2 sided|||Δs on SDMT (baseline vs 12 months)||||.639
71002760|NCT02033850|141513110|SUPERIORITY|||||||0.098|||||||t-test, 2 sided|||Δs on ROCF copy (baseline vs 6 months)||||.098
71002761|NCT02033850|141513110|SUPERIORITY|||||||0.235|||||||t-test, 2 sided|||Δs on ROCF copy (6 vs 12 months)||||.235
71002762|NCT02033850|141513110|SUPERIORITY|||||||0.789|||||||t-test, 2 sided|||Δs on ROCF copy (baseline vs 12 months)||||.789
71002763|NCT02033850|141513111|SUPERIORITY|||||||0.743|||||||t-test, 2 sided|||Δs on Stroop test (baseline vs 6 months)||||.743
71002764|NCT02033850|141513111|SUPERIORITY|||||||0.428|||||||t-test, 2 sided|||Δs on Stroop test (6 vs 12 months)||||.428
71002765|NCT02033850|141513111|SUPERIORITY|||||||0.294|||||||t-test, 2 sided|||Δs on Stroop test (baseline vs 12 months)||||.294
71002766|NCT02033850|141513111|SUPERIORITY|||||||0.157|||||||t-test, 2 sided|||Δs on TMT-A (baseline vs 6 months)||||.157
71002767|NCT02033850|141513111|SUPERIORITY|||||||0.094|||||||t-test, 2 sided|||Δs on TMT-A (6 vs 12 months)||||.094
71002768|NCT02033850|141513111|SUPERIORITY|||||||0.476|||||||t-test, 2 sided|||Δs on TMT-A (baseline vs 12 months)||||.476
71002769|NCT02033850|141513111|SUPERIORITY|||||||0.142|||||||t-test, 2 sided|||Δs on TMT-B (baseline vs 6 months)||||.142
71043081|NCT06442410|141595024|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS.|||||<|0.0001|||||||Chi-squared|||||||<0.0001
71002770|NCT02033850|141513111|SUPERIORITY|||||||0.651|||||||t-test, 2 sided|||Δs on TMT-B (6 vs 12 months)||||.651
71002771|NCT02033850|141513111|SUPERIORITY|||||||0.534|||||||t-test, 2 sided|||Δs on TMT-B (baseline vs 12 months)||||.534
71002772|NCT02033850|141513112|SUPERIORITY|||||||0.882|||||||t-test, 2 sided|||Δs on phonemic fluency (baseline vs 6 months)||||.882
71002773|NCT02033850|141513112|SUPERIORITY|||||||0.835|||||||t-test, 2 sided|||Δs on phonemic fluency (6 vs 12 months)||||.835
71002774|NCT02033850|141513112|SUPERIORITY|||||||0.951|||||||t-test, 2 sided|||Δs on phonemic fluency (baseline vs 12 months)||||.951
71002775|NCT02033850|141513112|SUPERIORITY|||||||0.392|||||||t-test, 2 sided|||Δs on semantic fluency (baseline vs 6 months)||||.392
71002776|NCT02033850|141513112|SUPERIORITY|||||||0.973|||||||t-test, 2 sided|||Δs on semantic fluency (6 vs 12 months)||||.973
71002777|NCT02033850|141513112|SUPERIORITY|||||||0.486|||||||t-test, 2 sided|||Δs on semantic fluency (baseline vs 12 months)||||.486
71002778|NCT02033850|141513113|SUPERIORITY|||||||0.92|||||||Chi-squared|||MoCA variations (baseline vs 6 months)||||.920
71002779|NCT02033850|141513113|SUPERIORITY|||||||0.17|||||||Chi-squared|||MoCA variations (6 vs 12 months)||||.170
71002780|NCT02033850|141513113|SUPERIORITY|||||||0.716|||||||Chi-squared|||MoCA variations (baseline vs 12 months)||||.716
71002781|NCT02033850|141513113|SUPERIORITY|||||||0.973|||||||Chi-squared|||MMSE variations (baseline vs 6 months)||||.973
71002782|NCT02033850|141513113|SUPERIORITY|||||||0.973|||||||Chi-squared|||MMSE variations (6 vs 12 months)||||.973
71002783|NCT02033850|141513113|SUPERIORITY|||||||0.3|||||||Chi-squared|||MMSE variations (baseline vs 12 months)||||.300
71002784|NCT02033850|141513113|SUPERIORITY|||||||0.068|||||||Chi-squared|||RAVL immed. variations (baseline vs 6 months)||||.068
71002785|NCT02033850|141513113|SUPERIORITY|||||||0.089|||||||Chi-squared|||RAVL immed. variations (6 vs 12 months)||||.089
71002786|NCT02033850|141513113|SUPERIORITY|||||||0.241|||||||Chi-squared|||RAVL immed. variations (baseline vs 12 months)||||.241
71002787|NCT02033850|141513113|SUPERIORITY|||||||0.089|||||||Chi-squared|||RAVL recall variations (baseline vs 6 months)||||.089
71002788|NCT02033850|141513113|SUPERIORITY|||||||0.17|||||||Chi-squared|||RAVL recall variations (6 vs 12 months)||||.170
71002789|NCT02033850|141513113|SUPERIORITY|||||||0.413|||||||Chi-squared|||RAVL recall variations (baseline vs 12 months)||||.413
71002790|NCT02033850|141513113|SUPERIORITY|||||||0.777|||||||Chi-squared|||ROCF recall variations (baseline vs 6 months)||||.777
71002791|NCT02033850|141513113|SUPERIORITY|||||||0.134|||||||Chi-squared|||ROCF recall variations (6 vs 12 months)||||.134
71002792|NCT02033850|141513113|SUPERIORITY|||||||0.498|||||||Chi-squared|||ROCF recall variations (baseline vs 12 months)||||.498
71002793|NCT02033850|141513113|SUPERIORITY|||||||0.942|||||||Chi-squared|||Short story variations (baseline vs 6 months)||||.942
71002794|NCT02033850|141513113|SUPERIORITY|||||||0.578|||||||Chi-squared|||Short story variations (6 vs 12 months)||||.578
71002795|NCT02033850|141513113|SUPERIORITY|||||||0.413|||||||Chi-squared|||Short story variations (baseline vs 12 months)||||.413
71002796|NCT02033850|141513113|SUPERIORITY|||||||1|||||||Chi-squared|||Visual search variations (baseline vs 6 months)||||1
71002797|NCT02033850|141513113|SUPERIORITY|||||||0.038|||||||Chi-squared|||Visual search variations (6 vs 12 months)||||.038
71043082|NCT06442410|141595025|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS|||||<|0.0001|||||||Chi-squared|||||||<0.0001
71043083|NCT06442410|141595026|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS.|||||<|0.0001|||||||Chi-squared|||||||<0.0001
71043084|NCT06442410|141595027|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS|||||<|0.0001|||||||Chi-squared|||||||<0.0001
71043085|NCT06442410|141595028|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS|||||<|0.0001|||||||Chi-squared|||||||<0.0001
71043086|NCT06442410|141595029|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS|||||<|0.0001|||||||Chi-squared|||||||<0.0001
71043087|NCT06442410|141595030|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS|||||<|0.0001|||||||Chi-squared|||||||<0.0001
71002798|NCT02033850|141513113|SUPERIORITY|||||||0.658|||||||Chi-squared|||Visual search variations (baseline vs 12 months)||||.658
71002799|NCT02033850|141513113|SUPERIORITY|||||||0.522|||||||Chi-squared|||SDMT variations (baseline vs 6 months)||||.522
71002800|NCT02033850|141513113|SUPERIORITY|||||||0.674|||||||Chi-squared|||SDMT variations (6 vs 12 months)||||.674
71002801|NCT02033850|141513113|SUPERIORITY|||||||0.17|||||||Chi-squared|||SDMT variations (baseline vs 12 months)||||.170
71002802|NCT02033850|141513113|SUPERIORITY|||||||0.961|||||||Chi-squared|||Stroop test variations (baseline vs 6 months)||||.961
71002803|NCT02033850|141513113|SUPERIORITY|||||||0.413|||||||Chi-squared|||Stroop test variations (6 vs 12 months)||||.413
71002804|NCT02033850|141513113|SUPERIORITY|||||||0.477|||||||Chi-squared|||Stroop test variations (baseline vs 12 months)||||.477
71002805|NCT02033850|141513113|SUPERIORITY|||||||0.42|||||||Chi-squared|||TMT-A variations (baseline vs 6 months)||||.420
71002806|NCT02033850|141513113|SUPERIORITY|||||||0.241|||||||Chi-squared|||TMT-A variations (6 vs 12 months)||||.241
71002807|NCT02033850|141513113|SUPERIORITY|||||||0.295|||||||Chi-squared|||TMT-A variations (baseline vs 12 months)||||.295
71002808|NCT02033850|141513113|SUPERIORITY|||||||0.453|||||||Chi-squared|||TMT-B variations (baseline vs 6 months)||||.453
71002809|NCT02033850|141513113|SUPERIORITY|||||||0.952|||||||Chi-squared|||TMT-B variations (6 vs 12 months)||||.952
71002810|NCT02033850|141513113|SUPERIORITY|||||||0.881|||||||Chi-squared|||TMT-B variations (baseline vs 12 months)||||.881
71002811|NCT02033850|141513113|SUPERIORITY|||||||0.413|||||||Chi-squared|||Phonemic fluency variations (baseline vs 6 months)||||.413
71002812|NCT02033850|141513113|SUPERIORITY|||||||0.961|||||||Chi-squared|||Phonemic fluency variations (6 vs 12 months)||||.961
71100908|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with impaired vulvar skin and positive AWR?||||||0.8732|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with impaired vulvar skin and positive AWR.||||0.8732
71100909|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with impaired vulvar skin and positive AWR?||||||0.0602|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with impaired vulvar skin and positive AWR.||||0.0602
71002813|NCT02033850|141513113|SUPERIORITY|||||||0.951|||||||Chi-squared|||Phonemic fluency variation (baseline vs 12 months)||||.951
71002814|NCT02033850|141513113|SUPERIORITY|||||||0.951|||||||Chi-squared|||Semantic fluency variations (baseline vs 6 months)||||.951
71002815|NCT02033850|141513113|SUPERIORITY|||||||0.674|||||||Chi-squared|||Semantic fluency variations (6 vs 12 months)||||.674
71002816|NCT02033850|141513113|SUPERIORITY|||||||0.951|||||||Chi-squared|||Semantic fluency variation (baseline vs 12 months)||||.951
71002817|NCT02033850|141513113|SUPERIORITY|||||||1|||||||Chi-squared|||ROCF copy variations (baseline vs 6 months)||||1
71002818|NCT02033850|141513113|SUPERIORITY|||||||0.027|||||||Chi-squared|||ROCF copy variations (6 vs 12 months)||||.027
71002819|NCT02033850|141513113|SUPERIORITY|||||||0.169|||||||Chi-squared|||ROCF copy variations (baseline vs 12 months)||||.169
71002820|NCT02033850|141513114|SUPERIORITY|||||||0.478|||||||Chi-squared|||||||.478
71002821|NCT02033850|141513115|SUPERIORITY|||||||0.029||||||"Corrected for multiple comparisons using the 3D parameter settings with threshold-free cluster enhancement.~A priori threshold for statistical significance 0.05"|General linear model voxel-wise|||Z-transformed ReHo difference in vermis VIIIb||||0.029
71002822|NCT02033850|141513115|SUPERIORITY|||||||0.04||||||"Corrected for multiple comparisons using the 3D parameter settings with threshold-free cluster enhancement.~A priori threshold for statistical significance 0.05"|General linear model voxel-wise|||Z-transformed ReHo difference in right VIIb lobule||||0.04
71002823|NCT02033850|141513115|SUPERIORITY|||||||0.039||||||"Corrected for multiple comparisons using the 3D parameter settings with threshold-free cluster enhancement.~A priori threshold for statistical significance 0.05"|General linear model voxel-wise|||Z-transformed ReHo difference in left VIIb lobule||||0.039
71002824|NCT02820038|141513116|SUPERIORITY||Odds Ratio (OR)|1.08||||0.8408|TWO_SIDED|95.0|0.52|2.24|||Regression, Logistic|Regression model adjusted for whether participant met criteria for informed decision making at baseline.|Modeled probability of meeting criteria for informed decision making at the 6-month follow-up. Independent variable coded: 0=Other Consumer Medication Information (CMI) Only, Other CMI+SMART, DrugFactsBox® (DFB) Only; 1=DFB+SMART|The investigators hypothesized that participants would be more likely to meet the criteria for Informed Decision-Making at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||2.24|0.52|0.8408
71002825|NCT02820038|141513116|SUPERIORITY||Odds Ratio (OR)|1.18||||0.58|TWO_SIDED|95.0|0.66|2.12|||Regression, Logistic|Regression model adjusted for whether participant met criteria for informed decision making at baseline.|Modeled probability of meeting criteria for informed decision making at the 6-month follow-up. Independent variable coded: 0=Other CMI Only or Other CMI+SMART, 1=DFB or DFB + SMART|The investigators hypothesized that participants would be more likely to meet the criteria for Informed Decision-Making at the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||2.12|0.66|0.58
71002826|NCT02820038|141513116|SUPERIORITY||Odds Ratio (OR)|1.48||||0.1937|TWO_SIDED|95.0|0.82|2.68|||Regression, Logistic|Regression model adjusted for whether participant met criteria for informed decision making at baseline.|Modeled probability of meeting criteria for informed decision making at the 6-month follow-up. Independent variable coded: 0=Other CMI Only or DFB Only, 1=Other CMI + SMART or DFB+SMART.|The investigators hypothesized that participants would be more likely to meet the criteria for Informed Decision-Making at the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||2.68|0.82|0.1937
71100910|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR?||||||0.0079|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR.||||0.0079
71002827|NCT02820038|141513116|SUPERIORITY||Odds Ratio (OR)|2.379||||0.0193|TWO_SIDED|95.0|1.15|4.92|||Regression, Logistic|Sample restricted to participants who did not meet the criteria for informed decision making at baseline.|Modeled probability of meeting criteria for informed decision making at the 6-month follow-up. Independent variable coded: 0=Other CMI Only or DFB Only, 1=Other CMI + SMART or DFB+SMART.|In this analysis, participants were restricted to those who did not meet criteria for informed decision-making at baseline.||4.92|1.15|0.0193
71002828|NCT02820038|141513116|SUPERIORITY||Odds Ratio (OR)|0.53||||0.2216|TWO_SIDED|95.0|0.19|1.48|||Regression, Logistic||Modeled probability of meeting criteria for informed decision making at the 6-month follow-up. Independent variable coded: 0=Other CMI Only or DFB Only, 1=Other CMI + SMART or DFB+SMART.|In this analysis, participants were restricted to those who met the criteria for informed decision-making at baseline.||1.48|0.19|0.2216
71002829|NCT02820038|141513117|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-1.83|STANDARD_ERROR_OF_MEAN|1.32||0.163|TWO_SIDED|95.0|-1.83|0.75|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in knowledge between baseline and the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.75|-1.83|0.1630
71002830|NCT02820038|141513117|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|1.05||0.7892|TWO_SIDED|95.0|-2.33|1.77|||Regression, Linear|||The investigators hypothesized that participants would exhibit a greater increase in knowledge between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.|Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|1.77|-2.33|0.7892
71043088|NCT02688387|141595089|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0667|||||TWO_SIDED|90.0|0.9657|1.1784|||||X1 Vs R1, ambrisentan|||1.1784|0.9657|
71043089|NCT02688387|141595089|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0353|||||TWO_SIDED|90.0|0.9293|1.1534|||||X2 Vs R2, ambrisentan|||1.1534|0.9293|
71043090|NCT02688387|141595089|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|0.9839|||||TWO_SIDED|90.0|0.9288|1.0423|||||X1 Vs R1, tadalafil|||1.0423|0.9288|
71043091|NCT02688387|141595089|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|0.9656|||||TWO_SIDED|90.0|0.9151|1.0188|||||X2 Vs R2, tadalafil|||1.0188|0.9151|
71043092|NCT02688387|141595090|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.03|||||TWO_SIDED|90.0|0.9965|1.0646|||||X1 Vs R1, ambrisentan|||1.0646|0.9965|
71100911|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with impaired vulvar skin and positive AWR?||||||0.2081|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with impaired vulvar skin and positive AWR.||||0.2081
71100912|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with impaired vulvar skin and positive AWR?||||||0.8732|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with impaired vulvar skin and positive AWR.||||0.8732
71002831|NCT02820038|141513117|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-2.19|STANDARD_ERROR_OF_MEAN|1.05||0.0377|TWO_SIDED|95.0|-4.25|-0.13|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in knowledge between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||-0.13|-4.25|0.0377
71043093|NCT02688387|141595090|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0141|||||TWO_SIDED|90.0|0.982|1.0473|||||X2 Vs R2, ambrisentan|||1.0473|0.9820|
71043094|NCT02688387|141595090|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|0.9693|||||TWO_SIDED|90.0|0.931|1.0092|||||X1 Vs R1, tadalafil|||1.0092|0.9310|
71043095|NCT02688387|141595090|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0157|||||TWO_SIDED|90.0|0.9553|1.0799|||||X2 Vs R2, tadalafil|||1.0799|0.9553|
71002832|NCT02820038|141513118|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.53||0.9216|TWO_SIDED|95.0|-0.98|1.08|||Regression, Linear|||The investigators hypothesized that participants would exhibit a greater increase in values favorable to aggressive therapy between baseline and the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.|Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|1.08|-0.98|0.9216
71002833|NCT02820038|141513118|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.36|STANDARD_ERROR_OF_MEAN|0.42||0.3843|TWO_SIDED|95.0|-0.45|1.17|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in values favoring aggressive therapy between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||1.17|-0.45|0.3843
71002834|NCT02820038|141513118|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.27|STANDARD_ERROR_OF_MEAN|0.42||0.509|TWO_SIDED|95.0|-0.54|1.09|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in values favoring aggressive therapy between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||1.09|-0.54|0.5090
71002835|NCT02820038|141513119|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.23||0.1486|TWO_SIDED|95.0|-0.77|0.12|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in gist reasoning ability at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.12|-0.77|0.1486
71002836|NCT02820038|141513119|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.18||0.4888|TWO_SIDED|95.0|-0.47|0.22|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in gist reasoning ability between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.22|-0.47|0.4888
71002837|NCT02820038|141513119|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.18||0.8637|TWO_SIDED|95.0|-0.32|0.38|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in gist reasoning ability between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.38|-0.32|0.8637
71002838|NCT02820038|141513120|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.25||0.507|TWO_SIDED|95.0|-0.33|0.66|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater gist reasoning ability at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.66|-0.33|0.5070
71002839|NCT02820038|141513120|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.19||0.4821|TWO_SIDED|95.0|-0.25|0.52|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in gist reasoning ability between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.52|-0.25|0.4821
71002840|NCT02820038|141513120|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.2||0.7777|TWO_SIDED|95.0|-0.33|0.44|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in gist reasoning ability between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.44|-0.33|0.7777
71002841|NCT02820038|141513121|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.64||0.6084|TWO_SIDED|95.0|-0.93|1.58|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in satisfaction at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||1.58|-0.93|0.6084
71002842|NCT02820038|141513121|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.26|STANDARD_ERROR_OF_MEAN|0.5||0.597|TWO_SIDED|95.0|-0.71|1.23|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in satisfaction between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||1.23|-0.71|0.5970
71002843|NCT02820038|141513121|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.5||0.5094|TWO_SIDED|95.0|-0.65|1.31|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in satisfaction between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||1.31|-0.65|.5094
71043096|NCT02688387|141595091|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0278|||||TWO_SIDED|90.0|0.9943|1.0623|||||X1 Vs R1, ambrisentan|||1.0623|0.9943|
71002844|NCT02820038|141513122|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-1.48|STANDARD_ERROR_OF_MEAN|2.74||0.5866|TWO_SIDED|95.0|-6.85|3.89|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in satisfaction at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||3.89|-6.85|0.5866
71002845|NCT02820038|141513122|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|2.13||0.8689|TWO_SIDED|95.0|-3.82|4.52|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in satisfaction between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||4.52|-3.82|0.8689
71002846|NCT02820038|141513122|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|1.66|STANDARD_ERROR_OF_MEAN|2.14||0.4356|TWO_SIDED|95.0|-2.53|5.86|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in satisfaction between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||5.86|-2.53|.4356
71002847|NCT02820038|141513123|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|3.48|STANDARD_ERROR_OF_MEAN|2.95||0.2366|TWO_SIDED|95.0|-2.3|9.26|||Regression, Linear|||The investigators hypothesized that participants would exhibit greater increases in self-efficacy at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||9.26|-2.30|0.2366
71002848|NCT02820038|141513123|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|2.29||0.8841|TWO_SIDED|95.0|-4.16|4.83|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in self-efficacy between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||4.83|-4.16|0.8841
71043097|NCT02688387|141595091|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0144|||||TWO_SIDED|90.0|0.9832|1.0466|||||X2 Vs R2, ambrisentan|||1.0466|0.9832|
71100913|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Sulcus versus Urethral Meatus in patients with impaired vulvar skin and positive AWR?||||||0.0852|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Sulcus versus Urethral Meatus in patients with impaired vulvar skin and positive AWR.||||0.0852
71100914|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Sulcus versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR?||||||0.0125|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Sulcus versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR.||||0.0125
70924534|NCT03562377|141341622|SUPERIORITY||Risk Difference (RD)|12.7||||0.057|TWO_SIDED|95.0|-0.2|25.7||The p-value was adjusted for multiplicity by a pre-specified testing hierarchy. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders in the primary analysis of the primary estimand.|Cochran-Mantel-Haenszel|The difference in response rates was analysed using the Cochran-Mantel-Haenszel test stratified by baseline disease severity (moderate or severe).||||25.7|-0.2|0.057
70924535|NCT03001414|141341625|SUPERIORITY||Mean Difference (Final Values)|13.7|STANDARD_ERROR_OF_MEAN|16.69||0.42|TWO_SIDED|95.0|-20.08|47.48|||ANOVA|Global test of difference between the arms analyzed as absolute change from baseline.||Due to sample size restriction, the primary analysis plan was modified to analyze change from baseline to each time point using repeated measures of ANOVA.||47.48|-20.08|0.42
70924536|NCT03001414|141341625|SUPERIORITY||Mean Difference (Final Values)|13.7||||0.57|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Calculation of raw change from baseline in meters using non-parametric Wilcoxon test.||||0.57
70924537|NCT03001414|141341625|SUPERIORITY||Mean Difference (Final Values)|4.55||||0.53|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Secondary analysis of primary outcome using non-parametric Wilcoxon test of percent change from baseline.||||||0.53
70924538|NCT03001414|141341626|SUPERIORITY|Change from baseline calculated in meters using non-parametric analysis.|Mean Difference (Final Values)|41.97||||0.1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of these arms is in accordance with the statistical analysis plan.||||0.10
71002849|NCT02820038|141513123|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|1.45|STANDARD_ERROR_OF_MEAN|2.3||0.5264|TWO_SIDED|95.0|-3.05|5.95|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in self-efficacy between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||5.95|-3.05|0.5264
71002850|NCT02820038|141513124|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|2.19||0.9604|TWO_SIDED|95.0|-4.4|4.18|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in medication adherence at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||4.18|-4.40|0.9604
71008611|NCT02055976|141525232|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-48.845|STANDARD_ERROR_OF_MEAN|3.456|<|0.001|TWO_SIDED|95.0|-55.709|-41.982|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-41.982|-55.709|<0.001
70924539|NCT03001414|141341627|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.5|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The selected arm for this outcome measure is in accordance with the statistical analysis plan.||||0.50
70924540|NCT03001414|141341628|SUPERIORITY||Mean Difference (Final Values)|22.92||||0.88|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Comparison of change from baseline in meters at 6 and 12 months.||Selection of the arm for analysis of this outcome measure is in accordance with the statistical analysis plan.||||0.88
70924541|NCT03001414|141341629|SUPERIORITY||Mean Difference (Final Values)|0.132||||0.81|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Selection of the arms for analysis of this outcome measure is in accordance with the statistical analysis plan.||||0.81
70924542|NCT03001414|141341630|SUPERIORITY||Median Difference (Final Values)|2.06||||0.63|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Selection of the arms for analysis of this outcome measure is in accordance with the statistical analysis plan.||||0.63
70924543|NCT03001414|141341631|SUPERIORITY||Mean Difference (Final Values)|1.39||||0.25|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.25
70924544|NCT03001414|141341632|SUPERIORITY||Mean Difference (Final Values)|5.6||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|This analysis represents the results for the Physical Component score of the questionnaire.||Selection of the arms for analysis of this outcome measure is in accordance with the statistical analysis plan.||||1.0
70924545|NCT03001414|141341632|SUPERIORITY||Median Difference (Final Values)|0.1||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||This analysis represents the difference in score for the mental component of the questionnaire.|Selection of the arms for analysis of this outcome measure is in accordance with the statistical analysis plan.||||0.64
70924546|NCT03001414|141341633|SUPERIORITY||Mean Difference (Final Values)|8.0||||0.4|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||This analysis represents the difference in score for the physical component of the questionnaire.|Selection of the arms for analysis of this outcome measure is in accordance with the statistical analysis plan.||||0.40
70924547|NCT03001414|141341633|SUPERIORITY||Mean Difference (Final Values)|15.4||||0.23|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||||This analysis represents the change in score for the mental component of the questionnaire.|||0.23
70924548|NCT03930342|141341664|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.83|1.07|||Regression, Logistic|Used marginal standardization to estimate relative risk from logistic regression||Results here reflect analysis of the relative risk for AEP that is a combination of risk from baseline to the 3 month timepoint and risk between the 3 month timepoint and 6 month timepoint. This reflects changes in AEP risk across the course of exposure to the intervention (baseline to 3 month) and enduring change post-exposure (3 months to 6 months)||1.07|0.83|
70924549|NCT01804816|141341751|EQUIVALENCE|a=0.05||||||0.063|||||||t-test, 2 sided|||||||0.063
70924550|NCT01804816|141341752|EQUIVALENCE|a = 0.05||||||0.005|||||||t-test, 2 sided|||Based on results from prior small clinical trials we estimate the need for 20 patients enrolled to reach 80% statistical power.||||0.005
70924551|NCT01804816|141341752|EQUIVALENCE|a=0.05||||||0.002|||||||t-test, 2 sided|||||||0.002
70924552|NCT01804816|141341752|EQUIVALENCE|a=0.05||||||0.441|||||||t-test, 2 sided|||||||0.441
70924553|NCT01804816|141341753|EQUIVALENCE|a=0.05||||||0.729|||||||t-test, 2 sided|||||||0.729
71002851|NCT02820038|141513124|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-3.62|STANDARD_ERROR_OF_MEAN|1.64||0.0279|TWO_SIDED|95.0|-6.84|-0.4|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in adherence between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||-0.40|-6.84|0.0279
71002852|NCT02820038|141513124|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|3.92|STANDARD_ERROR_OF_MEAN|1.66||0.0184|TWO_SIDED|95.0|0.67|7.18|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in medication adherence between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||7.18|0.67|0.0184
71002853|NCT02820038|141513125|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|2.79|STANDARD_ERROR_OF_MEAN|2.73||0.3056|TWO_SIDED|95.0|-2.56|8.14|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater decreases in illness intrusiveness at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||8.14|-2.56|0.3056
71002854|NCT02820038|141513125|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|4.19|STANDARD_ERROR_OF_MEAN|2.11||0.0466|TWO_SIDED|95.0|0.06|8.32|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in illness intrusiveness between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||8.32|0.06|0.0466
71002855|NCT02820038|141513125|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.024|STANDARD_ERROR_OF_MEAN|2.11||0.9106|TWO_SIDED|95.0|-4.38|3.9|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in illness intrusiveness between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||3.90|-4.38|0.9106
71002856|NCT02820038|141513126|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.17||0.1762|TWO_SIDED|95.0|-0.57|0.1|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group..|The investigators hypothesized that participants would exhibit greater decreases in health distress at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.10|-0.57|0.1762
71002857|NCT02820038|141513126|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.4186|TWO_SIDED|95.0|-0.36|0.15|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in health distress between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.15|-0.36|0.4186
71002858|NCT02820038|141513126|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.13||0.8848|TWO_SIDED|95.0|-0.28|0.24|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in health distress between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.24|-0.28|0.8848
71002859|NCT02820038|141513127|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.1||0.6403|TWO_SIDED|95.0|-0.15|0.25|||Regression, Linear|||The investigators hypothesized that participants would exhibit greater increases in health status at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.25|-0.15|0.6403
71002860|NCT02820038|141513127|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.08||0.8766|TWO_SIDED|95.0|-0.14|0.16|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in global health status between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.16|-0.14|0.8766
70924554|NCT03400059|141341755|SUPERIORITY||Mean Difference (Final Values)|-2.23||||0.0132|TWO_SIDED|95.0|-4.11|-0.49||"analysis of covariance (ANCOVA) model containing terms for treatment, baseline value and medication overuse.~Group-sequential analysis using updated boundaries from interim analysis"|ANCOVA|||||-0.49|-4.11|0.0132
70924555|NCT03400059|141341756|SUPERIORITY||Mean Difference (Final Values)|-2.68||||0.0014|TWO_SIDED|95.0|-4.32|-1.04|||ANCOVA|ANCOVA model containing terms for treatment, baseline value and medication overuse||||-1.04|-4.32|0.0014
70924556|NCT03400059|141341757|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.0048|TWO_SIDED|95.0|-4.06|-0.73|||ANCOVA|ANCOVA model containing terms for treatment, baseline value and medication overuse||||-0.73|-4.06|0.0048
70924557|NCT03400059|141341758|SUPERIORITY||Mean Difference (Final Values)|-2.87||||0.0008|TWO_SIDED|95.0|-4.54|-1.2|||ANCOVA|ANCOVA model containing terms for treatment, baseline value and medication overuse.||||-1.20|-4.54|0.0008
70924558|NCT03400059|141341759|SUPERIORITY||Mean Difference (Final Values)|-1.53||||0.0598|TWO_SIDED|95.0|-3.12|0.06|||ANCOVA|ANCOVA model containing terms for treatment, baseline value and medication overuse.||||0.06|-3.12|0.0598
71002861|NCT02820038|141513127|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.08||0.7603|TWO_SIDED|95.0|-0.13|0.18|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater improvement in global health status between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.18|-0.13|0.7603
71002862|NCT02820038|141513128|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.27||0.7093|TWO_SIDED|95.0|-0.43|0.63|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater decreases in disease activity at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.63|-0.43|0.7093
70924559|NCT03400059|141341760|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.031|TWO_SIDED|95.0|-3.63|-0.17|||ANCOVA|ANCOVA model containing terms for treatment, baseline value and medication overuse.||||-0.17|-3.63|0.0310
70924560|NCT03400059|141341761|SUPERIORITY|||||||0.0102|||||||Chi-squared|||||||0.0102
70924561|NCT03400059|141341762|SUPERIORITY|||||||0.1615|||||||Chi-squared|||||||0.1615
70924562|NCT03400059|141341763|SUPERIORITY|||||||0.0798|||||||Chi-squared|||||||0.0798
70924563|NCT03400059|141341764|SUPERIORITY|||||||0.13|||||||Chi-squared|||||||0.1300
70924564|NCT03400059|141341765|SUPERIORITY||Median Difference (Final Values)|-1.0||||0.066|TWO_SIDED|||||posthoc|Van-Elteren|||||||0.0660
70924565|NCT03400059|141341766|SUPERIORITY||Median Difference (Final Values)|-2.0||||0.0152|TWO_SIDED|||||posthoc|Van-Elteren|||||||0.0152
70924566|NCT04150718|141341784|OTHER||||||<|0.05||||||a priori threshold for statistical significance set at \<0.05|ANOVA|Repeated measures ANOVA, main effect of time, F(1,35) =4.73||||||<0.05
70924567|NCT04150718|141341785|OTHER||||||<|0.05||||||a priori threshold for statistical significance set at p\<0.05.|ANOVA|Repeated Measures ANOVA, main effect of time, F(1,39) = 4.20||||||<0.05
70924568|NCT04150718|141341786|OTHER||||||<|0.001||||||a priori threshold for statistical significance set at p \<0.05|ANOVA|Repeated measures ANOVA interaction, F(1,48) = 61.849||||||<0.001
70924569|NCT03958955|141341802|SUPERIORITY||Attributable risk|-0.14||||0.4531|TWO_SIDED|95.0|-0.37|0.09||Exact p-value of McNemar's test.|McNemar||Attributable risk is defined as the difference in estimated probability of treatment success of delgocitinib compared to vehicle. Exact p-value of McNemar's test. Success is defined as having an IGA score of 0 (clear) or 1 (almost clear) at Week 6.|||0.09|-0.37|0.4531
70924570|NCT03958955|141341805|SUPERIORITY||Attributable risk|0.07||||0.5|TWO_SIDED|95.0|-0.02|0.17||Exact p-value of McNemar's test.|McNemar||Attributable risk is defined as the difference in estimated probability of treatment success (i.e. no lesion-specific treatment-related AEs) of delgocitinib compared to vehicle. Exact p-value of McNemar's test.|||0.17|-0.02|0.5000
70924571|NCT03958955|141341806|SUPERIORITY||Attributable risk|-0.14||||0.4531|TWO_SIDED|95.0|-0.37|0.09||Exact p-value of McNemar's test.|McNemar||Attributable risk is defined as the difference in estimated probability of treatment success of delgocitinib vs vehicle. Exact p-value of McNemar's test. Success is defined as having at least a 2-point reduction in IGA score from baseline to Week 6.|||0.09|-0.37|0.4531
70924572|NCT03958955|141341807|SUPERIORITY||Attributable risk|0.0||||1|TWO_SIDED|95.0|-0.22|0.22||Exact p-value of McNemar's test.|McNemar||||Attributable risk is defined as the difference in estimated probability of treatment success of delgocitinib compared to vehicle. Exact p-value of McNemar's test. Success is defined as having at least a 2-point reduction in IGA score from baseline to Week 6.|0.22|-0.22|1.0000
70924573|NCT03958955|141341808|SUPERIORITY|||||||0.5797||||||P-value of the Wilcoxon signed rank test.|Wilcoxon signed rank test|Erythema is scored as 0=absent, 1=pink, faint, 2=red, 3=dark red, purple/violaceous/crusted/haemorrhagic. P-value of the Wilcoxon signed rank test.||||||0.5797
70924574|NCT03958955|141341809|SUPERIORITY|||||||0.7862||||||P-value of the Wilcoxon signed rank test.|Wilcoxon signed rank test|P-value of the Wilcoxon signed rank test.||Total skin disease activity score is the sum of the scores for erythema, scaling/hyperkeratosis, and oedema/infiltration. Total skin disease activity score ranges from 0 to 7 with lower score indicating better state.||||0.7862
70924575|NCT04638829|141341816|OTHER|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
70924576|NCT04638829|141341817|OTHER|||||||0.0093|||||||t-test, 2 sided|||||||0.0093
70924577|NCT04638829|141341818|OTHER|||||||0.0003|||||||t-test, 2 sided|||||||0.0003
71002863|NCT02820038|141513128|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.21||0.5941|TWO_SIDED|95.0|-0.3|0.52|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in disease activity between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.52|-0.30|0.5941
71002864|NCT02820038|141513128|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.21||0.9476|TWO_SIDED|95.0|-0.42|0.4|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in disease activity between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.40|-0.42|0.9476
71002865|NCT02820038|141513129|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.8||0.9128|TWO_SIDED|95.0|-1.65|1.48|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater decreases in depression at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||1.48|-1.65|0.9128
71043098|NCT02688387|141595091|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|0.9612|||||TWO_SIDED|90.0|0.9265|0.9972|||||X1 Vs R1, tadalafil|||0.9972|0.9265|
71043099|NCT02688387|141595091|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0122|||||TWO_SIDED|90.0|0.9562|1.0715|||||X2 Vs R2, tadalafil|||1.0715|0.9562|
71043100|NCT02688387|141595092|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0153|||||TWO_SIDED|90.0|0.9348|1.1027|||||Y1 Vs R3, ambrisentan|||1.1027|0.9348|
71043101|NCT02688387|141595092|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|0.9758|||||TWO_SIDED|90.0|0.9044|1.0529|||||Y1 Vs R3, tadalafil|||1.0529|0.9044|
71043102|NCT02688387|141595093|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.039|||||TWO_SIDED|90.0|1.0168|1.0617|||||Y1 Vs R3, ambrisentan|||1.0617|1.0168|
71100915|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with impaired vulvar skin and positive AWR?||||||0.0125|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with impaired vulvar skin and positive AWR.||||0.0125
71043103|NCT02688387|141595093|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|0.9806|||||TWO_SIDED|90.0|0.9106|1.056|||||Y1 Vs R3, tadalafil|||1.0560|0.9106|
71043104|NCT02688387|141595094|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0365|||||TWO_SIDED|90.0|1.0138|1.0596|||||Y1 Vs R3, ambrisentan|||1.0596|1.0138|
71043105|NCT02688387|141595094|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|0.9821|||||TWO_SIDED|90.0|0.9145|1.0547|||||Y1 Vs R3, tadalafil|||1.0547|0.9145|
71043106|NCT02688387|141595095|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.1176|||||TWO_SIDED|90.0|1.0166|1.2287|||||Y2 Vs R4, ambrisentan|||1.2287|1.0166|
71043107|NCT02688387|141595095|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.1196|||||TWO_SIDED|90.0|1.0429|1.2019|||||Y2 Vs R4, tadalafil|||1.2019|1.0429|
71100916|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with impaired vulvar skin and positive AWR?||||||0.2714|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with impaired vulvar skin and positive AWR.||||0.2714
71043108|NCT02688387|141595096|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0353|||||TWO_SIDED|90.0|1.0009|1.071|||||Y2 Vs R4, ambrisentan|||1.0710|1.0009|
71043109|NCT02688387|141595096|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0362|||||TWO_SIDED|90.0|0.991|1.0834|||||Y2 Vs R4, tadalafil|||1.0834|0.9910|
71100917|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with normal vulva and positive AWR?||||||0.1692|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with normal vulva and positive AWR.||||0.1692
70924578|NCT04638829|141341819|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71002866|NCT02820038|141513129|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.62||0.6312|TWO_SIDED|95.0|-1.5|0.91|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in depression between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.91|-1.50|0.6312
71002867|NCT02820038|141513129|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.35|STANDARD_ERROR_OF_MEAN|0.62||0.5766|TWO_SIDED|95.0|-1.57|0.87|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in depression between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.87|-1.57|0.5766
71002868|NCT02820038|141513130|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|1.04||0.2123|TWO_SIDED|95.0|-3.34|0.75|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater decreases in fatigue at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.75|-3.34|0.2123
71002869|NCT02820038|141513130|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.89|STANDARD_ERROR_OF_MEAN|0.81||0.2691|TWO_SIDED|95.0|-2.48|0.7|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in fatigue between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.70|-2.48|0.2691
71008612|NCT02055976|141525232|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-55.114|STANDARD_ERROR_OF_MEAN|3.526|<|0.001|TWO_SIDED|95.0|-62.116|-48.112|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-48.112|-62.116|<0.001
71100918|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with normal vulva and positive AWR?||||||0.0772|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with normal vulva and positive AWR.||||0.0772
71100919|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with normal vulva and positive AWR?||||||0.5762|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with normal vulva and positive AWR.||||0.5762
70924579|NCT02807636|141341841|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0073|TWO_SIDED|95.0|0.7|0.96||inverse normal combination|Log Rank|||Stratification factors: Enrollment stage, PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||0.96|0.70|0.0073
70924580|NCT02807636|141341842|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.023|TWO_SIDED|95.0|0.73|1.0||one-sided, inverse normal combination|Regression, Cox|||Stratification factors: Enrollment stage, PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||1.0|0.73|0.0230
71100920|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with normal vulva and positive AWR?||||||0.5762|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with normal vulva and positive AWR.||||0.5762
71100921|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with normal vulva and positive AWR?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with normal vulva and positive AWR.||||1.0000
71100922|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with normal vulva and positive AWR?||||||0.0078|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with normal vulva and positive AWR.||||0.0078
70924581|NCT02807636|141341843|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.3968|TWO_SIDED|95.0|0.82|1.16|||Log Rank|one-sided||Stratification factors: PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||1.16|0.82|0.3968
70924582|NCT02807636|141341848|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0373|TWO_SIDED|95.0|0.73|1.01||inverse normal combination|Regression, Cox|||Stratification factors: Enrollment stage, PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||1.01|0.73|0.0373
70924583|NCT02807636|141341849|SUPERIORITY||Difference in Event Free Rate|5.0||||0.1509|TWO_SIDED|95.0|-1.82|11.81|||Z-test|||Stratification factors: Enrollment stage, PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||11.81|-1.82|0.1509
70924584|NCT02807636|141341850|SUPERIORITY||Difference in Event Free Rate|3.36||||0.3761|TWO_SIDED|95.0|-4.08|10.79|||Z-test|||Stratification factors: Enrollment stage, PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||10.79|-4.08|0.3761
70924585|NCT02807636|141341851|SUPERIORITY||Difference in Event Free Rate|-8.29||||0.0083|TWO_SIDED|95.0|-14.45|-2.13|||Z-test|||Stratification factors: Enrollment stage, PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||-2.13|-14.45|0.0083
70924586|NCT02807636|141341852|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0542|TWO_SIDED|95.0|0.64|1.0|||Log Rank|||Strata are: Enrollment Stage, PD-L1 Status, BAJORIN Risk Factor Score and Stratum 4 for all participants.||1.00|0.64|0.0542
70924587|NCT02807636|141341853|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.6139|TWO_SIDED|95.0|0.74|1.19|||Log Rank|||Strata are: PD-L1 Status, BAJORIN Risk Factor Score and Stratum 4 for all participants.||1.19|0.74|0.6139
70924588|NCT02807636|141341854|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.554|TWO_SIDED|95.0|0.86|1.32|||Log Rank|||Strata are: Enrollment Stage, PD-L1 Status, BAJORIN Risk Factor Score and Stratum 4 for all participants.||1.32|0.86|0.5540
70924589|NCT02807636|141341855|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.0241|TWO_SIDED|95.0|1.03|1.62|||Log Rank|||Strata are: Enrollment Stage, PD-L1 Status, BAJORIN Risk Factor Score and Stratum 4 for all participants.||1.62|1.03|0.0241
70924590|NCT02807636|141341859|SUPERIORITY||Hazard Ratio (HR)|1.42||||1|TWO_SIDED|95.0|1.19|1.69|||Log Rank|||Stratification factors: PD-L1 status and Bajorin risk score/presence of liver metastases and investigator choice of chemotherapy.||1.69|1.19|1.0000
70924591|NCT04088630|141341865|SUPERIORITY|||||||0.0427||||||p\<0.05 considered significant. Between group pairwise comparisons performed with Bonferroni correction.|Fisher Exact|||Difference in proportion of subjects with cardiac events up to 30 days post-ictus tested between three groups.||||0.0427
70924592|NCT04088630|141341866|SUPERIORITY|||||||0.19|||||||Fisher Exact|||Difference in proportion of subjects with nosocomial infections up to 90 days post-ictus tested between three groups. No pairwise comparisons performed.||||0.19
70924593|NCT04088630|141341867|SUPERIORITY|||||||0.3|||||||Fisher Exact|||Difference in proportion of subjects with neurologic decline up to 30 days post-ictus tested between three groups. No pairwise comparisons performed.||||0.30
70924594|NCT05034952|141341902|SUPERIORITY|||||||0.3914|||||||ANCOVA|||||||0.3914
70924595|NCT05034952|141341902|SUPERIORITY|||||||0.1266|||||||ANCOVA|||||||0.1266
70924596|NCT05034952|141341902|SUPERIORITY|||||||0.0097|||||||ANCOVA|||||||0.0097
70924597|NCT05034952|141341903|SUPERIORITY|||||||0.5476|||||||ANCOVA|||||||0.5476
70924598|NCT05034952|141341903|SUPERIORITY|||||||0.0825|||||||ANCOVA|||||||0.0825
70924599|NCT05034952|141341903|SUPERIORITY|||||||0.0036|||||||ANCOVA|||||||0.0036
70924600|NCT05034952|141341904|SUPERIORITY|||||||0.4712|||||||Cochran-Mantel-Haenszel|||||||0.4712
70924601|NCT05034952|141341904|SUPERIORITY|||||||0.1635|||||||Cochran-Mantel-Haenszel|||||||0.1635
71002870|NCT02820038|141513130|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.47|STANDARD_ERROR_OF_MEAN|0.81||0.5655|TWO_SIDED|95.0|-2.06|1.13|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in fatigue between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||1.13|-2.06|0.5655
71043110|NCT02688387|141595097|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0351|||||TWO_SIDED|90.0|1.0002|1.0713|||||Y2 Vs R4, ambrisentan|||1.0713|1.0002|
70924602|NCT05034952|141341904|SUPERIORITY|||||||0.1158|||||||Cochran-Mantel-Haenszel|||||||0.1158
70924603|NCT05034952|141341905|SUPERIORITY|||||||0.2882|||||||Cochran-Mantel-Haenszel|||||||0.2882
70924604|NCT05034952|141341905|SUPERIORITY|||||||0.2344|||||||Cochran-Mantel-Haenszel|||||||0.2344
70924605|NCT05034952|141341905|SUPERIORITY|||||||0.1724|||||||Cochran-Mantel-Haenszel|||||||0.1724
70924606|NCT05034952|141341906|SUPERIORITY|||||||0.1343|||||||Cochran-Mantel-Haenszel|||||||0.1343
70924607|NCT05034952|141341906|SUPERIORITY|||||||0.4501|||||||Cochran-Mantel-Haenszel|||||||0.4501
70924608|NCT05034952|141341906|SUPERIORITY|||||||0.1009|||||||Cochran-Mantel-Haenszel|||||||0.1009
70924609|NCT02111798|141341908|SUPERIORITY|||||||0.889|||||||Mixed Models Analysis|||Comparisons were conducted as a function of medication condition, collapsed across abstinence initiation and relapse prevention groups, according to a priori-stated statistical analysis.||||0.889
70924610|NCT02111798|141341909|SUPERIORITY|||||||0.605|||||||Mixed Models Analysis|||Comparisons were conducted as a function of medication condition, collapsed across abstinence initiation and relapse prevention groups, according to a priori-stated statistical analysis.||||0.605
70924611|NCT05493787|141341910|SUPERIORITY|||||||0.003||||||Comparisons between Passive Control and all other arms (Analyses 1-5) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Flu shot self-scheduling does not differ between those sent an Active Control message and those not sent a message (i.e., those in the Passive Control group); Alternative hypothesis: Sending an Active Control message increases self-scheduling compared with sending no message. Analysis combines across November and December send dates.||||.003
70924612|NCT05493787|141341910|SUPERIORITY||||||<|0.001||||||Comparisons between Passive Control and all other arms (Analyses 1-5) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Flu shot self-scheduling does not differ between those sent an Ease message and those not sent a message (i.e., those in the Passive Control group); Alternative hypothesis: Sending an Ease message increases self-scheduling compared with sending no message. Analysis combines across November and December send dates.||||<.001
71043111|NCT02688387|141595097|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0324|||||TWO_SIDED|90.0|0.9929|1.0734|||||Y2 Vs R4, tadalafil|||1.0734|0.9929|
71043112|NCT04403399|141595149|SUPERIORITY||Mean Difference (Final Values)|-3.62||||0.003|TWO_SIDED||||||Mixed Models Analysis|||||||0.003
71043113|NCT04403399|141595150|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.73|TWO_SIDED||||||Mixed Models Analysis|||||||0.73
71043114|NCT04403399|141595151|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.03|TWO_SIDED||||||Mixed Models Analysis|||||||0.03
70924613|NCT05493787|141341910|SUPERIORITY||||||<|0.001||||||Comparisons between Passive Control and all other arms (Analyses 1-5) were analyzed in the same regression.|Regression, Linear|||Null hypothesis: Flu shot self-scheduling does not differ between those sent an Waiting for You message message and those not sent a message (i.e., those in the Passive Control group); Alternative hypothesis: Sending a Waiting for You message increases self-scheduling compared with sending no message. Analysis combines across November and December send dates.||||<.001
70924614|NCT05493787|141341910|SUPERIORITY|||||||0.003||||||Comparisons between Passive Control and all other arms (Analyses 1-5) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Flu shot self-scheduling does not differ between those sent a Protect Yourself - Rare message and those not sent a message (i.e., those in the Passive Control group); Alternative hypothesis: Sending a Protect Yourself - Rare Message increases self-scheduling compared with sending no message. Analysis combines across November and December send dates.||||.003
70924615|NCT05493787|141341910|SUPERIORITY|||||||0.035||||||Comparisons between Passive Control and all other arms (Analyses 1-5) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Flu shot self-scheduling does not differ between those sent a Protect Yourself - Frequent message and those not sent a message (i.e., those in the Passive Control group); Alternative hypothesis: Sending a Protect Yourself - Frequent message increases self-scheduling compared with sending no message. Analysis combines across November and December send dates.||||.035
70924616|NCT05493787|141341910|SUPERIORITY|||||||0.593||||||Comparisons between Active Control and all other arms (Analyses 6-9) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Active Control messages and Ease messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: Ease messages are more effective at promoting flu shot self-scheduling than Active Control messages. Analysis combines across November and December send dates.||||.593
71002871|NCT02820038|141513131|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|2.52|STANDARD_ERROR_OF_MEAN|4.1||0.5364|TWO_SIDED|95.0|-5.51|10.55|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in health literacy at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||10.55|-5.51|0.5364
71002872|NCT02820038|141513131|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|1.67|STANDARD_ERROR_OF_MEAN|3.24||0.605|TWO_SIDED|95.0|-4.68|8.01|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in health literacy between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||8.01|-4.68|0.6050
71100923|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with normal vulva and positive AWR?||||||0.6862|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with normal vulva and positive AWR.||||0.6862
71100924|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with normal vulva and positive AWR?||||||0.0563|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with normal vulva and positive AWR.||||0.0563
70924617|NCT05493787|141341910|SUPERIORITY|||||||0.052||||||Comparisons between Active Control and all other arms (Analyses 6-9) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Active Control messages and Waiting for You messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: Waiting for You messages are more effective at promoting flu shot self-scheduling than Active Control messages. Analysis combines across November and December send dates.||||.052
70924618|NCT05493787|141341910|SUPERIORITY|||||||0.952||||||Comparisons between Active Control and all other arms (Analyses 6-9) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Active Control messages and Protect Yourself - Rare messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: Protect Yourself - Rare messages are more effective at promoting flu shot self-scheduling than Active Control messages. Analysis combines across November and December send dates.||||.952
70924619|NCT05493787|141341910|SUPERIORITY|||||||0.386||||||Comparisons between Active Control and all other arms (Analyses 6-9) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Active Control messages and Protect Yourself - Frequent messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: Protect Yourself - Frequent messages are more effective at promoting flu shot self-scheduling than Active Control messages. Analysis combines across November and December send dates.||||.386
71100925|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with normal vulva and positive AWR?||||||0.0563|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with normal vulva and positive AWR.||||0.0563
71100926|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with normal vulva and positive AWR?||||||0.1692|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with normal vulva and positive AWR.||||0.1692
71100927|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with normal vulva and positive AWR?||||||0.1822|||||||t|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with normal vulva and positive AWR.||||0.1822
71002873|NCT02820038|141513131|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|3.24||0.924|TWO_SIDED|95.0|-6.66|6.05|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in health literacy between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||6.05|-6.66|0.9240
71002874|NCT02820038|141513132|SUPERIORITY||Odds Ratio (OR)|0.9||||0.7871|TWO_SIDED|95.0|0.43|1.89|||Regression, Logistic||Modeled probability of attending at least one class session. Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART|The investigators hypothesized that participants would be more likely to participate in the BetterChoices, BetterHealth program if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||1.89|0.43|0.7871
71002875|NCT02820038|141513132|SUPERIORITY||Odds Ratio (OR)|1.189||||0.5815|TWO_SIDED|95.0|0.643|2.198|||Regression, Logistic||Modeled probability of attending at least one class. Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART.|The investigators hypothesized that participants would be more likely to participate in at least one session of the BetterChoices,BetterHealth program if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||2.198|0.643|0.5815
71002876|NCT02820038|141513132|SUPERIORITY||Odds Ratio (OR)|0.679||||0.2211|TWO_SIDED|95.0|0.366|1.262|||Regression, Logistic||Modeled probability of attending at least one class. Independent variable coded: 0=Other CMI Only, DFB Only; 1=Other CMI+SMART, DFB+SMART.|The investigators hypothesized that participants would be more likely to participate in at least one session of the BetterChoices, BetterHealth program if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||1.262|0.366|0.2211
71002877|NCT02820038|141513133|SUPERIORITY||Odds Ratio (OR)|0.804||||0.574|TWO_SIDED|95.0|0.38|1.72|||Regression, Logistic||Modeled probability of viewing at least one page on website. Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART|The investigators hypothesized that participants would be more likely to use the RA Self-Management website if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||1.72|0.38|0.5740
71002878|NCT02820038|141513133|SUPERIORITY||Odds Ratio (OR)|1.425||||0.1278|TWO_SIDED|95.0|0.766|2.649|||Regression, Logistic||Modeled probability of viewing at least one page on website. Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART.|The investigators hypothesized that participants would be more likely to visit the RA Self-Management Website if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||2.649|0.766|0.1278
71002879|NCT02820038|141513133|SUPERIORITY||Odds Ratio (OR)|0.614||||0.1278|TWO_SIDED|95.0|0.328|1.15|||Regression, Logistic||Modeled probability of viewing at least one page on website. Independent variable coded: 0=Other CMI Only, DFB Only; 1=Other CMI+SMART, DFB+SMART.|The investigators hypothesized that participants would be more likely to visit the RA Self-Management Website if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||1.15|0.328|0.1278
71002880|NCT02820038|141513134|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|11.9|STANDARD_ERROR_OF_MEAN|8.7||0.17|TWO_SIDED|95.0|-5.2|28.9|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in visual selective learning between baseline and the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||28.9|-5.2|0.17
71002881|NCT02820038|141513134|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable|Mean Difference (Net)|16.0|STANDARD_ERROR_OF_MEAN|6.9||0.02|TWO_SIDED|95.0|2.5|29.5|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in visual selective learning between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||29.5|2.5|0.02
71002882|NCT02820038|141513134|SUPERIORITY|Regression model adjusted for baseline values of the dependent variable.|Mean Difference (Net)|5.6|STANDARD_ERROR_OF_MEAN|6.9||0.42|TWO_SIDED|95.0|-8.1|19.2|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=Other CMI+SMART, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would experience a greater increase in visual selective learning between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||19.2|-8.1|0.42
71002883|NCT02820038|141513135|SUPERIORITY||Mean Difference (Net)|-2.2|STANDARD_ERROR_OF_MEAN|0.15||0.15|TWO_SIDED|95.0|-5.2|0.8|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater medication self-management knowledge at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.8|-5.2|0.15
71002884|NCT02820038|141513135|SUPERIORITY||Mean Difference (Net)|-2.1|STANDARD_ERROR_OF_MEAN|1.2||0.07|TWO_SIDED|95.0|-4.4|0.3|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater medication self-management knowledge at the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.3|-4.4|0.07
71002885|NCT02820038|141513135|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|1.2||0.13|TWO_SIDED|95.0|-4.2|0.6|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would experience greater medication self-management knowledge at the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.6|-4.2|0.13
71002886|NCT02820038|141513136|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.12||0.68|TWO_SIDED|95.0|-0.19|0.29|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater verbatim recall of information concerning medication benefits and risks at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.29|-0.19|0.68
71002887|NCT02820038|141513136|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.1||0.2|TWO_SIDED|95.0|-0.06|0.31|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater verbatim recall of information concerning medication benefits and risks at the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.31|-0.06|0.20
71002888|NCT02820038|141513136|SUPERIORITY||Mean Difference (Net)|0.001|STANDARD_ERROR_OF_MEAN|0.1||0.99|TWO_SIDED|95.0|-0.19|0.19|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=Other CMI+SMART, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater verbatim recall of information concerning medication benefits and risks at the 6-week follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.19|-0.19|0.99
71002889|NCT02820038|141513137|SUPERIORITY||Odds Ratio (OR)|2.105||||0.0028|TWO_SIDED|95.0|1.291|3.432|||Regression, Logistic|||The investigators hypothesized that participants would be more likely to view at least one webpage if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.|Modeled probability of viewing at least one webpage. Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART.|3.432|1.291|0.0028
71002890|NCT02820038|141513138|SUPERIORITY||Mean Difference (Net)|-0.84|STANDARD_ERROR_OF_MEAN|0.45||0.0601|TWO_SIDED|95.0|-1.71|0.04|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would view more webpages if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.04|-1.71|0.0601
71002891|NCT02820038|141513139|SUPERIORITY||Odds Ratio (OR)|0.91||||0.9|TWO_SIDED|95.0|0.22|3.81|||Regression, Logistic||Independent variable coded: 0=Other Consumer Medication Information (CMI) Only, Other CMI+SMART, DrugFactsBox® (DFB) Only; 1=DFB+SMART|The investigators hypothesized that participants would be more likely to be using at least one DMARD (Disease-Modifying Antirheumatic Drug) at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||3.81|0.22|0.90
71043115|NCT00546910|141595164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|||<|0.001|TWO_SIDED|95.0|0.52|0.87||P-value is for Time Active overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Time Active was tested at rank 8.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.87|0.52|<0.001
71043116|NCT00546910|141595164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.27|||<|0.001|TWO_SIDED|95.0|0.98|1.57||P-value is for Distance overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Distance was tested at rank 5.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||1.57|0.98|<0.001
71043117|NCT00546910|141595164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08|||<|0.001|TWO_SIDED|95.0|0.81|1.35||P-value is for Area overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Area was tested at rank 6.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||1.35|0.81|<0.001
71100928|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Urethral Sulcus versus Urethral Meatus in patients with normal vulva and positive AWR?||||||0.022|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Urethral Sulcus versus Urethral Meatus in patients with normal vulva and positive AWR.||||0.0220
71043118|NCT00546910|141595164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|95.0|0.78|1.22||P-value is for Microevents overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Microevents was tested at rank 3.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||1.22|0.78|<0.001
71043119|NCT00546910|141595164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38|||<|0.001|TWO_SIDED|95.0|0.18|0.58||P-value is for Motion Simplicity overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Motion Simplicity was tested at rank 9.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.58|0.18|<0.001
71043120|NCT00546910|141595165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.6|||<|0.001|TWO_SIDED|95.0|8.2|14.99||P-value for ADHD-RS Total Score|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||Comparison of atomoxetine vs. placebo at Visit 7 (Week 8)||14.99|8.20|<0.001
71043121|NCT00546910|141595166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.11|||<|0.001|TWO_SIDED|95.0|0.76|1.46||P-value for CGI-S ADHD score|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||Comparison of atomoxetine vs. placebo at Visit 7 (Week 8)||1.46|0.76|<0.001
71043122|NCT00546910|141595167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.74|||<|0.001|TWO_SIDED|95.0|3.55|7.92||P-value for Total Score|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||7.92|3.55|<0.001
71043123|NCT00546910|141595167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.96||||0.001|TWO_SIDED|95.0|2.49|5.44||P-value for Evening subscore|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||5.44|2.49|0.001
71043124|NCT00546910|141595167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.18|||<|0.002|TWO_SIDED|95.0|0.42|1.93||P-value for Morning subscore|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||1.93|0.42|<0.002
71100929|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Urethral Sulcus versus Hymenal Remnants in patients with normal vulva and positive AWR?||||||0.022|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Urethral Sulcus versus Hymenal Remnants in patients with normal vulva and positive AWR.||||0.0220
71043125|NCT00546910|141595167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62|||<|0.001|TWO_SIDED|95.0|0.31|0.93||P-value for Item 11 (difficulty falling asleep).|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.93|0.31|<0.001
71100930|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with normal vulva and positive AWR?||||||0.022|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with normal vulva and positive AWR.||||0.0220
71043126|NCT00546910|141595168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01|||<|0.001|TWO_SIDED|95.0|0.66|1.35||P-value is for Reaction Time Variation overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Reaction time variation was tested at rank 1.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||1.35|0.66|<0.001
71043127|NCT00546910|141595168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|||<|0.001|TWO_SIDED|95.0|0.46|0.93||P-value is for Omission Error overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Omission error was tested at rank 7.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.93|0.46|<0.001
71043128|NCT00546910|141595168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|||<|0.001|TWO_SIDED|95.0|0.17|0.65||P-value is for Mean Reaction Time overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Mean reaction time was tested at rank 2.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.65|0.17|<0.001
71043129|NCT00546910|141595168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||<|0.001|TWO_SIDED|95.0|0.26|0.73||P-value is for Normalized Variation of Reaction Time overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Normalized Variation of Reaction Time was tested at rank 10.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.73|0.26|<0.001
71043130|NCT00546910|141595169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||<|0.001|TWO_SIDED|95.0|0.31|0.68||P-value is for Commission Error overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Commission Error was tested at rank 4.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.68|0.31|<0.001
71100931|NCT02732145|141709692|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with normal vulva and positive AWR?||||||0.0078|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with normal vulva and positive AWR.||||0.0078
70924620|NCT05493787|141341910|SUPERIORITY|||||||0.498||||||Pairwise comparisons between experimental arms (Analyses 10-15) were analyzed in the same regression. Reported p-values were 2-tailed and adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: Ease messages and Waiting for You messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: There is a difference in effectiveness between Ease and Waiting for You messages. Analysis combines across November and December send dates.||||.498
71100932|NCT02732145|141709693|EQUIVALENCE|Question: Is there a difference in the incidence of hyperkeratosis in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of hyperkeratosis in vulvar specimens of patients from different groups.||||0.0000
71100933|NCT02732145|141709693|EQUIVALENCE|Question: Is there a difference in the incidence of parakeratosis in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of parakeratosis in vulvar specimens of patients from different groups.||||0.0000
71100934|NCT02732145|141709693|EQUIVALENCE|Question: Is there a difference in the incidence of acanthosis in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of acanthosis in vulvar specimens of patients from different groups.||||0.0000
71100935|NCT02732145|141709693|EQUIVALENCE|Question: Is there a difference in the incidence of epidermal atrophy in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of epidermal atrophy in vulvar specimens of patients from different groups.||||0.0000
71100936|NCT02732145|141709693|EQUIVALENCE|Question: Is there a difference in the incidence of inflammatory infiltrates in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of inflammatory infiltrates in vulvar specimens of patients from different groups.||||0.0000
70924621|NCT05493787|141341910|SUPERIORITY|||||||0.935||||||Pairwise comparisons between experimental arms (Analyses 10-15) were analyzed in the same regression. Reported p-values were 2-tailed and adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: Ease messages and Protect Yourself - Rare messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: There is a difference in effectiveness between Ease and Protect Yourself - Rare messages. Analysis combines across November and December send dates.||||.935
70924622|NCT05493787|141341910|SUPERIORITY|||||||0.504||||||Pairwise comparisons between experimental arms (Analyses 10-15) were analyzed in the same regression. Reported p-values were 2-tailed and adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: Ease messages and Protect Yourself - Frequent messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: There is a difference in effectiveness between Ease and Protect Yourself - Frequent message messages. Analysis combines across November and December send dates.||||.504
70924623|NCT05493787|141341910|SUPERIORITY|||||||0.19||||||Pairwise comparisons between experimental arms (Analyses 10-15) were analyzed in the same regression. Reported p-values were 2-tailed and adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: Protect Yourself - Rare and Waiting for You messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: There is a difference in effectiveness between Protect Yourself - Rare and Waiting for You messages. Analysis combines across November and December send dates.||||.190
70924624|NCT05493787|141341910|SUPERIORITY|||||||0.027||||||Pairwise comparisons between experimental arms (Analyses 10-15) were analyzed in the same regression. Reported p-values were 2-tailed and adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: Protect Yourself - Frequent messages and Waiting for You messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: There is a difference in effectiveness between Protect Yourself - Frequent and Waiting for You messages. Analysis combines across November and December send dates.||||.027
70924625|NCT05493787|141341910|SUPERIORITY|||||||0.854||||||Pairwise comparisons between experimental arms (Analyses 10-15) were analyzed in the same regression. Reported p-values were 2-tailed and adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: Protect Yourself - Rare and Protect Yourself - Frequent messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: There is a difference in effectiveness between Protect Yourself - Rare and Protect Yourself - Frequent messages. Analysis combines across November and December send dates.||||.854
70924626|NCT05493787|141341910|SUPERIORITY|||||||0.637||||||The reported p-value (2-tailed) is for the interaction term between message send date (November, December) and message (any message arm no message)|Regression, Linear|||"Null Hypothesis: Messages sent in November and December are equally effective at promoting flu-shot self-scheduling. Alternative hypothesis: Messages sent in November and December are differentially effective.~To test the alternative hypothesis, all message arms (Active control, Ease, Waiting for you, Protect yourself - rare, Protect yourself - frequent) were combined and compared with Passive control."||||.637
71100937|NCT02732145|141709693|EQUIVALENCE|Question: Is there a difference in the incidence of mononuclear inflammatory infiltrates in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of mononuclear inflammatory infiltrates in vulvar specimens of patients from different groups.||||0.0000
71100938|NCT02732145|141709693|EQUIVALENCE|Question: Is there a difference in the incidence of lymphocytes in vulvar specimens of patients from different groups?||||||0.0105|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of lymphocytes (infiltrates) in vulvar specimens of patients from different groups.||||0.0105
71100939|NCT02732145|141709693|EQUIVALENCE|Question: Is there a difference in the incidence of mastocytes in vulvar specimens of patients from different groups?||||||0.0064|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of mastocytes in vulvar specimens of patients from different groups.||||0.0064
71100940|NCT02732145|141709693|EQUIVALENCE|Question: Is there a difference in the incidence of collagen fibers in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of collagen fibers in vulvar specimens of patients from different groups.||||0.0000
70924627|NCT02437318|141341960|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.00065|TWO_SIDED|95.0|0.5|0.85||(one-sided)|Log Rank|||||0.85|0.50|0.00065
70924628|NCT04321031|141342037|SUPERIORITY||Risk Difference (RD)|0.08|||||TWO_SIDED|90.0|-0.02|0.2|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the statistical analysis plan (SAP).||0.20|-0.02|
71002892|NCT02820038|141513139|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Odds Ratio (OR)|0.75||||0.63|TWO_SIDED|95.0|0.24|2.35|||Regression, Logistic||. Independent variable coded: 0=Other Consumer Medication Information (CMI) Only, Other CMI+SMART; 1=DFB Only, DFB+SMART|The investigators hypothesized that participants would exhibit a greater increase in the percentage of participants using at least one DMARD (Disease-Modifying Antirheumatic Drug) between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||2.35|0.24|0.63
71002893|NCT02820038|141513139|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Odds Ratio (OR)|1.15||||0.81|TWO_SIDED|95.0|0.37|3.54|||Regression, Logistic||Independent variable coded: 0=Other Consumer Medication Information (CMI) Only, DrugFactsBox® (DFB) Only; 1=Other CMI+SMART, DFB+SMART|The investigators hypothesized that participants would experience a greater increase in the percentage of participants using at least one DMARD (Disease-Modifying Antirheumatic Drug) between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||3.54|0.37|0.81
71002894|NCT00323427|141513187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|STANDARD_ERROR_OF_MEAN|0.0974||0.69|TWO_SIDED|95.0|-0.15|0.23||No multiple testing adjustment.|t-test, 2 sided|||H0: Mean(Arm 1) = Mean(Arm 2)||0.23|-0.15|0.69
71002895|NCT00323427|141513188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.14||0.42|TWO_SIDED|95.0|-0.16|0.38||No adjustment.|t-test, 2 sided|||H0: Mean(Arm 1) = Mean(Arm 2)||0.38|-0.16|0.42
71002896|NCT00323427|141513189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.15||0.97|TWO_SIDED|95.0|-0.3|0.29||No adjustment|t-test, 2 sided|||H0: mean(Arm 1) = Mean (Arm 2)||0.29|-0.30|0.97
71002897|NCT03039192|141513194|SUPERIORITY||Difference of Least Square Means|-3.8|STANDARD_ERROR_OF_MEAN|1.39||0.006|TWO_SIDED|95.0|-6.56|-1.09|||ANCOVA|||||-1.09|-6.56|0.006
71002898|NCT02493868|141513217|SUPERIORITY||Hazard Ratio (HR)|0.49|||=|0.003|TWO_SIDED|95.0|0.29|0.84|||Weighted Log-rank|||||0.84|0.29|= 0.003
71002899|NCT02407236|141513235|SUPERIORITY||Adjusted treatment difference|10.3|||<|0.001|TWO_SIDED|95.0|5.7|14.9|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with Cochran-Mantel-Haenszel (CMH) weight.|Statistical Analysis 1||14.9|5.7|< 0.001
71002900|NCT02407236|141513235|SUPERIORITY||Adjusted treatment difference|10.2|||<|0.001|TWO_SIDED|95.0|5.6|14.8|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with Cochran-Mantel-Haenszel (CMH) weight.|Statistical Analysis 2||14.8|5.6|< 0.001
71043131|NCT00546910|141595169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.022|TWO_SIDED|95.0|0.02|0.31||P-value is for Anticipatory Response overall for morning, noon and evening. Anticipatory Response was not tested in the primary analysis but is a secondary endpoint.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.31|0.02|0.022
71043132|NCT00546910|141595170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94|||<|0.001|TWO_SIDED|95.0|0.69|1.18||P-value is for Error Rate overall for morning, noon and evening. Error Rate was not tested in the primary analysis but is a secondary endpoint.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||1.18|0.69|<0.001
71100941|NCT02732145|141709693|EQUIVALENCE|Question: Is there a difference in the incidence of hyalinization in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of hyalinization in vulvar specimens of patients from different groups.||||0.0000
71002901|NCT02407236|141513236|SUPERIORITY||Adjusted treatment difference|10.3|||<|0.001|TWO_SIDED|97.5|4.8|15.8|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with Cochran-Mantel-Haenszel (CMH) weight.|Statistical Analysis 1||15.8|4.8|< 0.001
71002902|NCT02407236|141513236|SUPERIORITY||Adjusted treatment difference|12.7|||<|0.001|TWO_SIDED|97.5|7.0|18.4|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with Cochran-Mantel-Haenszel (CMH) weight.|Statistical Analysis 2||18.4|7.0|< 0.001
71002903|NCT02407236|141513237|SUPERIORITY||Adjusted treatment difference|14.5||||0.002|TWO_SIDED|95.0|5.5|23.6|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with CMH weight.|Statistical Analysis 1||23.6|5.5|0.002
71002904|NCT02407236|141513237|SUPERIORITY||Adjusted treatment difference|19.7|||<|0.001|TWO_SIDED|95.0|10.3|29.0|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with CMH weight.|Statistical Analysis 2||29.0|10.3|< 0.001
71002905|NCT02407236|141513238|SUPERIORITY||Adjusted treatment difference|15.1||||0.002|TWO_SIDED|95.0|6.0|24.2|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with CMH weight.|Statistical Analysis 1||24.2|6.0|0.002
71043133|NCT00546910|141595170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.178|TWO_SIDED|95.0|0.05|0.28||P-value is for Multi Response overall for morning, noon and evening. Multi Response was not tested in the primary analysis but is a secondary endpoint.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.28|0.05|0.178
71043134|NCT01115855|141595171|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.53|1.36||||||Cox Proportional Hazard Model with baseline New York Heart Association (NYHA) cohort (II, III/IV) and baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) covariates.||1.36|0.53|
71043135|NCT01115855|141595172|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.56|1.31||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||1.31|0.56|
70924629|NCT04321031|141342037|SUPERIORITY||Risk Difference (RD)|0.1|||||TWO_SIDED|90.0|-0.03|0.24|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.24|-0.03|
71002906|NCT02407236|141513238|SUPERIORITY||Adjusted treatment difference|17.9|||<|0.001|TWO_SIDED|95.0|8.6|27.2|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with CMH weight.|Statistical Analysis 2||27.2|8.6|< 0.001
71002907|NCT00089999|141513374|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.691|TWO_SIDED|95.0|0.3|1.9|||Fisher Exact|||||1.9|0.3|0.691
71002908|NCT00089999|141513375|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.443|TWO_SIDED|95.0|0.3|1.6|||Fisher Exact||Overall Response (i.e. sum of Complete and Partial Responses) comparison|||1.6|0.3|0.443
71002909|NCT01951326|141513469|SUPERIORITY|||||||0.0048|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0048
71002910|NCT01951326|141513470|SUPERIORITY|||||||0.0116|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0116
71002911|NCT01951326|141513471|SUPERIORITY|||||||0.0616|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0616
71002912|NCT01951326|141513472|SUPERIORITY|||||||0.0851|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0851
71002913|NCT01951326|141513473|SUPERIORITY|||||||0.0147|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0147
71002914|NCT01951326|141513474|SUPERIORITY|||||||0.151|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.1510
71100942|NCT02732145|141709693|EQUIVALENCE|Question: Is there a difference in the incidence of hyperpigmentation in vulvar specimens of patients from different groups?||||||0.0342|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of hyperpigmentation in vulvar specimens of patients from different groups.||||0.0342
71100943|NCT02732145|141709693|EQUIVALENCE|Question: Is there a difference in the incidence of elongated dermal papillae in vulvar specimens of patients from different groups?||||||0.0148|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of elongated dermal papillae in vulvar specimens of patients from different groups.||||0.0148
70924630|NCT04321031|141342037|SUPERIORITY||Risk Difference (RD)|0.12|||||TWO_SIDED|90.0|-0.03|0.26|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.26|-0.03|
70924631|NCT04321031|141342037|SUPERIORITY||Risk Difference (RD)|0.13|||||TWO_SIDED|90.0|-0.04|0.28|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.28|-0.04|
71002915|NCT01951326|141513475|SUPERIORITY|||||||0.2402|||||||Log Rank|||||||0.2402
71002916|NCT01951326|141513476|SUPERIORITY|||||||0.046|||||||Log Rank|||||||0.0460
71002917|NCT01951326|141513477|SUPERIORITY|||||||0.0031|||||||Log Rank|||||||0.0031
71002918|NCT01951326|141513478|SUPERIORITY|||||||0.01|||||||Log Rank|||||||0.0100
71002919|NCT01951326|141513479|SUPERIORITY|||||||0.0077|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0077
71002920|NCT01951326|141513480|SUPERIORITY|||||||0.0422|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0422
71100944|NCT02732145|141709693|EQUIVALENCE|Question: Is there a difference in the incidence of blood vessels in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of blood vessels in vulvar specimens of patients from different groups.||||0.0000
71100945|NCT02732145|141709693|EQUIVALENCE|Question: Is there a difference in the incidence of sebaceous glands in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of sebaceous glands in vulvar specimens of patients from different groups.||||0.0000
71002921|NCT04984876|141513483|OTHER||Odds Ratio (OR)|25.83||||0.002|TWO_SIDED|95.0|4.34|506.78|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||506.78|4.34|0.002
71002922|NCT04984876|141513483|OTHER||Odds Ratio (OR)|5.1||||0.073|TWO_SIDED|95.0|0.8|100.98|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||100.98|0.80|0.073
71002923|NCT04984876|141513484|OTHER||Odds Ratio (OR)|9.86||||0.018|TWO_SIDED|95.0|1.69|188.85|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||188.85|1.69|0.018
71002924|NCT04984876|141513484|OTHER||Odds Ratio (OR)|3.02||||0.164|TWO_SIDED|95.0|0.45|59.93|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||59.93|0.45|0.164
71002925|NCT04984876|141513485|OTHER||Odds Ratio (OR)|3.47||||0.138|TWO_SIDED|95.0|0.51|70.08|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||70.08|0.51|0.138
71002926|NCT04984876|141513485|OTHER||Odds Ratio (OR)|2.21||||0.247|TWO_SIDED|95.0|0.3|45.56|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||45.56|0.30|0.247
71100946|NCT02732145|141709693|EQUIVALENCE|Question: Is there a difference in the incidence of nerve fibers in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of nerve fibers in vulvar specimens of patients from different groups.||||0.0000
71002927|NCT04984876|141513486|OTHER||Odds Ratio (OR)|10.59|||<|0.001|TWO_SIDED|95.0|3.63|31.56|||proportional odds model||proportional odds model adjusting for treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), log transformed baseline total IgE at screening and region.|||31.56|3.63|<0.001
71002928|NCT04984876|141513486|OTHER||Odds Ratio (OR)|5.05||||0.001|TWO_SIDED|95.0|1.8|14.36|||proportional odds model||proportional odds model adjusting for treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), log transformed baseline total IgE at screening and region.|||14.36|1.80|0.001
71002929|NCT04984876|141513487|OTHER||Odds Ratio (OR)|4.73||||0.082|TWO_SIDED|95.0|0.74|93.16|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||93.16|0.74|0.082
71002930|NCT04984876|141513487|OTHER||Odds Ratio (OR)|0.61||||0.632|TWO_SIDED|95.0|0.02|16.43|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||16.43|0.02|0.632
71002931|NCT04984876|141513492|OTHER||LS Mean difference|-3.77|||<|0.001|TWO_SIDED|95.0|-5.15|-2.4|||ANCOVA||ANCOVA model with treatment group, age subgroup (12 - 17 years, 18 - 55 years), region, log-transformed baseline total IgE at screening and baseline SPT mean wheal diameter (average dilutions peanut protein) as covariates.|||-2.40|-5.15|<0.001
71002932|NCT04984876|141513492|OTHER||LS Mean difference|-4.93|||<|0.001|TWO_SIDED|95.0|-7.77|-2.09|||ANCOVA||ANCOVA model with treatment group, age subgroup (12 - 17 years, 18 - 55 years), region, log-transformed baseline total IgE at screening and baseline SPT mean wheal diameter (average dilutions peanut protein) as covariates.|||-2.09|-7.77|<0.001
71002933|NCT04984876|141513492|OTHER||LS Mean difference|-3.2||||0.015|TWO_SIDED|95.0|-6.08|-0.32|||ANCOVA||ANCOVA model with treatment group, age subgroup (12 - 17 years, 18 - 55 years), region, log-transformed baseline total IgE at screening and baseline SPT mean wheal diameter (average dilutions peanut protein) as covariates.|||-0.32|-6.08|0.015
71002934|NCT04984876|141513492|OTHER||LS Mean difference|-1.68||||0.13|TWO_SIDED|95.0|-4.62|1.25|||ANCOVA||ANCOVA model with treatment group, age subgroup (12 - 17 years, 18 - 55 years), region, log-transformed baseline total IgE at screening and baseline SPT mean wheal diameter (average dilutions peanut protein) as covariates.|||1.25|-4.62|0.130
71002935|NCT04984876|141513493|OTHER||LS Mean difference|-0.33||||0.173|TWO_SIDED|95.0|-1.03|0.36|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.36|-1.03|0.173
71002936|NCT04984876|141513493|OTHER||LS Mean difference|-0.29||||0.202|TWO_SIDED|95.0|-0.96|0.39|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.39|-0.96|0.202
71002937|NCT04984876|141513493|OTHER||LS Mean difference|-0.37||||0.151|TWO_SIDED|95.0|-1.09|0.34|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.34|-1.09|0.151
71002938|NCT04984876|141513493|OTHER||LS Mean difference|-0.23||||0.264|TWO_SIDED|95.0|-0.94|0.49|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.49|-0.94|0.264
71002939|NCT04984876|141513493|OTHER||LS Mean difference|-0.43||||0.123|TWO_SIDED|95.0|-1.16|0.3|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.30|-1.16|0.123
71043136|NCT01115855|141595173|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.77|||||TWO_SIDED|95.0|0.81|3.87||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||3.87|0.81|
71043137|NCT01115855|141595174|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.4|||||TWO_SIDED|95.0|0.92|6.24||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||6.24|0.92|
71002940|NCT04984876|141513493|OTHER||LS Mean difference|-0.23||||0.258|TWO_SIDED|95.0|-0.94|0.47|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.47|-0.94|0.258
71002941|NCT04984876|141513493|OTHER||LS Mean difference|-0.17||||0.324|TWO_SIDED|95.0|-0.92|0.58|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.58|-0.92|0.324
71002942|NCT04984876|141513493|OTHER||LS Mean difference|-0.03||||0.473|TWO_SIDED|95.0|-0.78|0.73|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.73|-0.78|0.473
71043138|NCT01115855|141595175|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.44|0.97||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||0.97|0.44|
71043139|NCT01115855|141595176|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.45|1.25||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||1.25|0.45|
71043140|NCT01115855|141595177|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.45|0.97||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||0.97|0.45|
71043141|NCT01115855|141595178|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.49|1.33||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>=-50 ml/min/1.73 m\^2) covariates.||1.33|0.49|
71002943|NCT04984876|141513494|OTHER||LS Mean difference|0.06||||0.597|TWO_SIDED|95.0|-0.44|0.57|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.57|-0.44|0.597
71002944|NCT04984876|141513494|OTHER||LS Mean difference|-0.39||||0.064|TWO_SIDED|95.0|-0.89|0.11|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.11|-0.89|0.064
71002945|NCT04984876|141513494|OTHER||LS Mean difference|-0.22||||0.191|TWO_SIDED|95.0|-0.72|0.28|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.28|-0.72|0.191
71002946|NCT04984876|141513494|OTHER||LS Mean difference|-0.02||||0.472|TWO_SIDED|95.0|-0.51|0.48|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.48|-0.51|0.472
71002947|NCT04984876|141513494|OTHER||LS Mean difference|0.03||||0.537|TWO_SIDED|95.0|-0.57|0.62|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.62|-0.57|0.537
70924632|NCT04321031|141342038|SUPERIORITY||Risk Difference (RD)|0.14|||||TWO_SIDED|90.0|-0.04|0.32||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.32|-0.04|
71002948|NCT04984876|141513494|OTHER||LS Mean difference|-0.32||||0.141|TWO_SIDED|95.0|-0.91|0.27|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.27|-0.91|0.141
71002949|NCT04984876|141513494|OTHER||LS Meand difference|-0.45||||0.063|TWO_SIDED|95.0|-1.04|0.13|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.13|-1.04|0.063
71002950|NCT04984876|141513494|OTHER||LS Mean difference|-0.1||||0.368|TWO_SIDED|95.0|-0.68|0.48|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.48|-0.68|0.368
71002951|NCT04984876|141513495|OTHER||LS Mean difference|-0.24||||0.225|TWO_SIDED|95.0|-0.87|0.39|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.39|-0.87|0.225
71100947|NCT02732145|141709694|SUPERIORITY|Question: Is there a difference in the incidence of vulvar complaints depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of vulvar complaints depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.0000
71100948|NCT02732145|141709694|SUPERIORITY|Question: Is there a difference in the incidence of symptoms of the dull pain of the vulva on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||1|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the dull (slow) pain of the vulva (burning, stinging, soreness, irritation, itching, inflammation, aching) depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||1.0000
71100949|NCT02732145|141709694|SUPERIORITY|Question: Is there a difference in the incidence of vulvar burning depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.3533|||||||Chi-squared|||Parameter: The incidence of vulvar burning depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.3533
71100950|NCT02732145|141709694|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.5641|||||||Chi-squared|||Parameter: The incidence of vulvar stinging depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.5641
71100951|NCT02732145|141709694|SUPERIORITY|Question: Is there a difference in the incidence of vulvar soreness depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.9684|||||||Chi-squared|||Parameter: The incidence of vulvar soreness depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.9684
71100952|NCT02732145|141709694|SUPERIORITY|Question: Is there a difference in the incidence of vulvar irritation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.8599|||||||Chi-squared|||Parameter: The incidence of vulvar irritation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.8599
71100953|NCT02732145|141709694|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.9402|||||||Chi-squared|||Parameter: The incidence of vulvar itching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.9402
71100954|NCT02732145|141709694|SUPERIORITY|Question: Is there a difference in the incidence of the feeling of vulvar inflammation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.8389|||||||Chi-squared|||Parameter: The incidence of the feeling of vulvar inflammation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.8389
71100955|NCT02732145|141709694|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.7617|||||||Chi-squared|||Parameter: The incidence of vulvar aching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.7617
71100956|NCT02732145|141709694|SUPERIORITY|Question: Is there a difference in the incidence of the sharp pain of the vulva depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.4613|||||||Chi-squared|||Parameter: The difference in the incidence of the sharp (fast) pain of the vulva (knife-like pain, paper-cuts pain, stabbing, sticking) depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.4613
70924633|NCT04321031|141342038|SUPERIORITY||Risk Difference (RD)|0.08|||||TWO_SIDED|90.0|-0.11|0.27||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.27|-0.11|
71002952|NCT04984876|141513495|OTHER||LS Mean difference|-0.32||||0.153|TWO_SIDED|95.0|-0.93|0.3|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.30|-0.93|0.153
71002953|NCT04984876|141513495|OTHER||LS Mean difference|-0.3||||0.179|TWO_SIDED|95.0|-0.95|0.34|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.34|-0.95|0.179
71002954|NCT04984876|141513495|OTHER||LS Mean difference|0.11||||0.631|TWO_SIDED|95.0|-0.55|0.77|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.77|-0.55|0.631
71002955|NCT04984876|141513495|OTHER||LS Mean difference|-0.52||||0.06|TWO_SIDED|95.0|-1.18|0.14|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.14|-1.18|0.060
71002956|NCT04984876|141513495|OTHER||LS Mean difference|-0.08||||0.404|TWO_SIDED|95.0|-0.72|0.56|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.56|-0.72|0.404
71002957|NCT04984876|141513495|OTHER||LS Mean difference|-0.38||||0.135|TWO_SIDED|95.0|-1.06|0.3|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.30|-1.06|0.135
71002958|NCT04984876|141513495|OTHER||LS Mean difference|0.01||||0.514|TWO_SIDED|95.0|-0.7|0.72|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.72|-0.70|0.514
71002959|NCT04984876|141513496|OTHER||LS Mean difference|0.04||||0.574|TWO_SIDED|95.0|-0.42|0.51|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.51|-0.42|0.574
71043142|NCT01115855|141595179|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.45|1.1||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||1.10|0.45|
71043143|NCT01115855|141595180|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.53|1.28||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||1.28|0.53|
71043144|NCT01115855|141595181|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.18|3.53||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||3.53|0.18|
71043145|NCT01115855|141595182|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.07|17.85||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||17.85|0.07|
71100957|NCT02732145|141709694|SUPERIORITY|Question: Is there a difference in the incidence of vulvar knife-like pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.0331|||||||Chi-squared, Corrected|||Parameter: The incidence of the vulvar knife-like pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.0331
71100958|NCT02732145|141709694|SUPERIORITY|Question: Is there a difference in the incidence of vulvar paper-cuts pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.9402|||||||Chi-squared|||Parameter: The incidence of the vulvar paper-cuts pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.9402
71043146|NCT01115855|141595183|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.11|||||TWO_SIDED|95.0|0.39|11.56||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||11.56|0.39|
71043147|NCT01115855|141595184|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.05|5.66||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||5.66|0.05|
71043148|NCT01115855|141595185|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.16|8.04||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||8.04|0.16|
71043149|NCT01115855|141595187|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-102.93|STANDARD_ERROR_OF_MEAN|47.13|||TWO_SIDED|95.0|-195.92|-9.94||||||Change from baseline at Month 5 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-9.94|-195.92|
71043150|NCT01115855|141595187|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-95.77|STANDARD_ERROR_OF_MEAN|44.54|||TWO_SIDED|95.0|-184.51|-7.04||||||Change from baseline at Month 9 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-7.04|-184.51|
71043151|NCT01115855|141595187|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-125.09|STANDARD_ERROR_OF_MEAN|35.15|||TWO_SIDED|95.0|-195.5|-54.68||||||Change from baseline at Month 13 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-54.68|-195.50|
71002960|NCT04984876|141513496|OTHER||LS Mean difference|-0.37||||0.056|TWO_SIDED|95.0|-0.83|0.09|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.09|-0.83|0.056
71002961|NCT04984876|141513496|OTHER||LS Mean difference|-0.36||||0.069|TWO_SIDED|95.0|-0.83|0.12|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.12|-0.83|0.069
71002962|NCT04984876|141513496|OTHER||LS Mean difference|-0.19||||0.205|TWO_SIDED|95.0|-0.65|0.27|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.27|-0.65|0.205
71002963|NCT04984876|141513496|OTHER||LS Mean difference|-0.2||||0.248|TWO_SIDED|95.0|-0.76|0.37|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.37|-0.76|0.248
71002964|NCT04984876|141513496|OTHER||LS Mean difference|-0.42||||0.071|TWO_SIDED|95.0|-0.98|0.14|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.14|-0.98|0.071
71002965|NCT04984876|141513496|OTHER||LS Mean difference|-0.49||||0.048|TWO_SIDED|95.0|-1.06|0.09|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.09|-1.06|0.048
71002966|NCT04984876|141513496|OTHER||LS Mean difference|-0.3||||0.142|TWO_SIDED|95.0|-0.85|0.25|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.25|-0.85|0.142
71002967|NCT01462045|141513502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.6|STANDARD_ERROR_OF_MEAN|5.7|<|0.01|TWO_SIDED|95.0|-25.6|-1.6|||t-test, 2 sided|||||-1.6|-25.6|<0.01
71002968|NCT01462045|141513503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|STANDARD_ERROR_OF_MEAN|2.4|<|0.01|TWO_SIDED|95.0|0.83|10.8|||t-test, 2 sided|||||10.8|0.83|<0.01
71002969|NCT01193049|141513504|SUPERIORITY_OR_OTHER||GM FR from Placebo: SP|0.25||||0.001|TWO_SIDED|90.0|0.14|0.46||1-sided p-value, α = 0.05|ANOVA|||GM Fold Reduction (FR) is the GM of individual FC(Prednisone)/FC (Placebo) from SP.||0.46|0.14|0.001
71002970|NCT01193049|141513504|SUPERIORITY_OR_OTHER||GM FR from Placebo : NE|0.2|||<|0.001|TWO_SIDED|90.0|0.13|0.3||1-sided p value, α = 0.05|ANOVA|||GM FR is the GM of individual FC(Prednisone)/FC(Placebo) from NE.||0.30|0.13|<0.001
71043152|NCT01115855|141595187|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-31.94|STANDARD_ERROR_OF_MEAN|51.12|||TWO_SIDED|95.0|-232.77|-31.11||||||Change from baseline at Month 17 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-31.11|-232.77|
71043153|NCT01115855|141595187|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-132.39|STANDARD_ERROR_OF_MEAN|52.77|||TWO_SIDED|95.0|-240.94|-23.84||||||Change from baseline at Month 21 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-23.84|-240.94|
71002971|NCT01193049|141513504|SUPERIORITY_OR_OTHER||Correlation FC from BL: SP vs NE|0.2||||0.553||||||Unadjusted for Baseline and Period Effects|Pearson's correlation coefficient|||Correlation between SP and NE of FC from BL in IL-5 after placebo treatment.||||0.553
71002972|NCT01193049|141513504|SUPERIORITY_OR_OTHER||Correlation FR from Placebo :SP vs NE|-0.02||||0.964||||||Unadjusted for Baseline and Period Effects|Pearson's correlation coefficient|||Correlation between SP and NE of FR from placebo in IL-5 after prednisone treatment.||||0.964
71002973|NCT01193049|141513505|SUPERIORITY_OR_OTHER||GM FR from Placebo: SP|0.27||||0.009|TWO_SIDED|90.0|0.12|0.62||1-sided p-value, α = 0.05|ANOVA|||GM FR is the GM of individual FC(Prednisone)/FC (Placebo) from SP.||0.62|0.12|0.009
71002974|NCT01193049|141513505|SUPERIORITY_OR_OTHER||GM FR from Placebo : NE|0.31|||<|0.001|TWO_SIDED|90.0|0.22|0.43||1-sided p-value, α = 0.05|ANOVA|||GM FR is the GM of individual FC Prednisone)/FC(Placebo) from NE.||0.43|0.22|<0.001
71002975|NCT01193049|141513505|SUPERIORITY_OR_OTHER||Correlation FC from BL: SP vs NE|-0.02||||0.962||||||Unadjusted for Baseline and Period Effects|Pearson's correlation coefficient|||Correlation between SP and NE of FC from BL in IL-13 after placebo treatment.||||0.962
71002976|NCT01193049|141513505|SUPERIORITY_OR_OTHER||Correlation FR from Placebo: SP vs NE|0.07||||0.83||||||Unadjusted for Baseline and Period Effects|Pearson's correlation coefficient|||Correlation between SP and NE of FR from placebo in IL-13 after prednisone treatment.||||0.83
71002977|NCT01193049|141513506|SUPERIORITY_OR_OTHER||GM FR from Placebo: SP|0.8||||0.258|TWO_SIDED|90.0|0.43|1.47||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) from SP.||1.47|0.43|0.258
71002978|NCT01193049|141513506|SUPERIORITY_OR_OTHER||GM FR from Placebo: NE|1.08||||0.681|TWO_SIDED|90.0|0.8|1.46||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) from NE.||1.46|0.80|0.681
71002979|NCT01193049|141513507|SUPERIORITY_OR_OTHER||GM FR from Placebo:SP|0.61||||0.117|TWO_SIDED|90.0|0.3|1.24||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) from SP.||1.24|0.30|0.117
71043154|NCT01115855|141595187|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-117.18|STANDARD_ERROR_OF_MEAN|51.76|||TWO_SIDED|95.0|-221.49|-12.87||||||Change from baseline at Month 25 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-12.87|-221.49|
71002980|NCT01193049|141513507|SUPERIORITY_OR_OTHER||GM FR from Placebo: NE|0.64||||0.011|TWO_SIDED|90.0|0.47|0.86||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) from NE.||0.86|0.47|0.011
71002981|NCT01193049|141513509|SUPERIORITY_OR_OTHER||GM FR from Placebo: IL-5|1.51||||0.01|TWO_SIDED|90.0|1.15|1.99||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) for IL-5.||1.99|1.15|0.010
71002982|NCT01193049|141513509|SUPERIORITY_OR_OTHER||GM FR from Placebo: IL-13|1.35||||0.02|TWO_SIDED|90.0|1.07|1.71||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC(Prednisone)/FC (Placebo) for IL-13.||1.71|1.07|0.020
71002983|NCT01193049|141513510|SUPERIORITY_OR_OTHER||GM FR from Placebo: SP|0.82||||0.119|TWO_SIDED|90.0|0.62|1.09||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) in IL-17 from SP.||1.09|0.62|0.119
71002984|NCT01193049|141513510|SUPERIORITY_OR_OTHER||GM FR from Placebo: NE|0.68||||0.103|TWO_SIDED|90.0|0.41|1.14||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) in IL-17 from NE.||1.14|0.41|0.103
71002985|NCT01193049|141513511|SUPERIORITY_OR_OTHER||GM FR from Placebo: SP|0.6||||0.003|TWO_SIDED|90.0|0.46|0.77||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) in IL-1β from SP.||0.77|0.46|0.003
71002986|NCT01193049|141513511|SUPERIORITY_OR_OTHER||GM FR from Placebo: NE|0.49||||0.036|TWO_SIDED|90.0|0.26|0.93||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC(Prednisone)/FC (Placebo) in IL-1β from NE.||0.93|0.26|0.036
71002987|NCT01193049|141513512|SUPERIORITY_OR_OTHER||GM FR from Placebo: SP|0.7||||0.143|TWO_SIDED|90.0|0.4|1.24||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC(Prednisone)/FC (Placebo) in MIP-1β from SP.||1.24|0.40|0.143
71002988|NCT01193049|141513512|SUPERIORITY_OR_OTHER||GM FR from Placebo: NE|0.61||||0.056|TWO_SIDED|90.0|0.37|1.02||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) in MIP-1β from NE.||1.02|0.37|0.056
71002989|NCT01726504|141513521|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||Mixed Models Analysis|||During the 8-week treatment period, the adjusted change from baseline in mean weekly CSBMs was 1.72 ± 0.12 (95% CI, 1.48 to 1.96) in the EA group and 0.82 ± 0.13 (95% CI, 0.58 to 1.07, P\<0.001) times more than that in the SA group.||||<0.001
71002990|NCT02436915|141513532|EQUIVALENCE|We hypothesized that the real tDCS would improve the performance of TUG (i.e., greater percent decrease of time to complete TUG from baseline to follow ups) as compared to the sham tDCS.||||||0.24|||||||ANOVA|||||||0.24
71002991|NCT02436915|141513533|EQUIVALENCE|We hypothesized that the real tDCS would improve the MoCA score (i.e., greater percent increase decrease of MoCA score from baseline to follow ups) as compared to the sham tDCS.||||||0.03|||||||ANOVA|||||||0.03
71043155|NCT01115855|141595187|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-101.5|STANDARD_ERROR_OF_MEAN|61.05|||TWO_SIDED|95.0|-267.36|64.36||||||Change from baseline at Month 29 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||64.36|-267.36|
71002992|NCT02436915|141513534|EQUIVALENCE|We hypothesized that the real tDCS would improve the dual task performance of walking (i.e., greater percent decrease of dual task cost to walking speed from baseline to follow ups) as compared to the sham tDCS.||||||0.37|||||||ANOVA|||||||0.37
71002993|NCT02436915|141513535|EQUIVALENCE|We hypothesized that the real tDCS would improve the performance of dual task standing (i.e., greater percent decrease of dual task cost to standing sway speed from baseline to follow ups) as compared to the sham tDCS.||||||0.004|||||||ANOVA|||||||0.004
71002994|NCT02436915|141513536|EQUIVALENCE|We hypothesized that the real tDCS would reduce the depression (i.e., greater percent decrease of GDS score from baseline to follow ups) as compared to the sham tDCS.||||||0.37|||||||ANOVA|||||||0.37
71002995|NCT02436915|141513537|EQUIVALENCE|We hypothesized that the real tDCS would improve the performance of TMT (i.e., greater percent decrease of time to complete TMT from baseline to follow ups) as compared to the sham tDCS.||||||0.54|||||||ANOVA|||||||0.54
71002996|NCT02436915|141513538|EQUIVALENCE|We hypothesized that the real tDCS would improve the performance of dual task standing (i.e., greater percent decrease of dual task cost to standing postural sway area from baseline to follow ups) as compared to the sham tDCS.||||||0.0007|||||||ANOVA|||||||0.0007
71002997|NCT02436915|141513539|EQUIVALENCE|We hypothesized that the real tDCS would improve the performance of walking (i.e., greater percent decrease of dual task cost to stride time from baseline to follow ups) as compared to the sham tDCS.||||||0.04|||||||ANOVA|||||||0.04
71002998|NCT03531762|141513565|OTHER||Ratio of Geometric Least Square Mean|108.87|||||TWO_SIDED|90.0|101.2|117.13||||||||117.13|101.20|
71002999|NCT03531762|141513566|OTHER||Ratio of Geometric Least Square Mean|109.8|||||TWO_SIDED|90.0|101.69|118.55||||||||118.55|101.69|
71003000|NCT03531762|141513567|OTHER||Ratio of Geometric Least Square Mean|104.1|||||TWO_SIDED|90.0|92.93|116.61||||||||116.61|92.93|
71003001|NCT00364832|141513595|SUPERIORITY_OR_OTHER||Estimated Conversion Factor 90% CI|0.81|||||TWO_SIDED|90.0|0.73|0.9|||||To analyze dose conversion factors (CF), 2nd regression (R) analysis was performed on 3 different CF dose groups, using the R slope estimates of Hb change over 6 weeks. Equi-effective CF was interpolated using value that gives an Hb change of zero.|All cohorts with dosing frequency 1x/ week (0.4, 0.8 and 1.2 dose group)||0.90|0.73|
71043156|NCT01115855|141595187|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-110.78|STANDARD_ERROR_OF_MEAN|92.42|||TWO_SIDED|95.0|-307.49|85.93||||||Change from baseline at Month 33 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||85.93|-307.49|
71043157|NCT01115855|141595187|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-119.62|STANDARD_ERROR_OF_MEAN|158.84|||TWO_SIDED|95.0|-2137.82|1898.59||||||Change from baseline at Month 37 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||1898.59|-2137.82|
71100959|NCT02732145|141709694|SUPERIORITY|Question: Is there a difference in the incidence of vulvar pain like stabbing depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.9139|||||||Chi-squared|||Parameter: The incidence of vulvar pain like stabbing depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.9139
71003002|NCT00364832|141513595|SUPERIORITY_OR_OTHER||Estimated Conversion Factor 90% CI|0.72|||||TWO_SIDED|90.0|0.55|0.86|||||To analyze dose conversion factors (CF), 2nd regression (R) analysis was performed on 3 different CF dose groups, using the R slope estimates of Hb change over 6 weeks. Equi-effective CF was interpolated using value that gives an Hb change of zero.|All cohorts with dosing frequency 1x/ 3 weeks (0.4, 0.8 and 1.2 dose group)||0.86|0.55|
71003003|NCT00364832|141513595|SUPERIORITY_OR_OTHER||Estimated Conversion Factor 90% CI|0.93|||||TWO_SIDED|90.0|0.81|1.09|||||To analyze dose conversion factors (CF), 2nd regression (R) analysis was performed on 3 different CF dose groups, using the R slope estimates of Hb change over 6 weeks. Equi-effective CF was interpolated using value that gives an Hb change of zero.|All cohorts with dosing frequency 1x/ 4 weeks (0.4, 0.8 and 1.2 dose group)||1.09|0.81|
71003004|NCT00762528|141513602|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
71003005|NCT00762528|141513603|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
71003006|NCT00762528|141513604|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
71003007|NCT00762528|141513605|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
71003008|NCT00762528|141513606|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
71003009|NCT00762528|141513607|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
71003010|NCT00762528|141513608|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
71003011|NCT00762528|141513609|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
71003012|NCT02658149|141513610|OTHER|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||||||0.036
71003013|NCT02658149|141513611|OTHER|||||||0.204|||||||Wilcoxon (Mann-Whitney)|||||||0.204
71003014|NCT02658149|141513612|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
71003015|NCT02658149|141513613|OTHER|||||||0.741|||||||t-test, 2 sided|||||||0.741
71003016|NCT02658149|141513614|OTHER|||||||1|||||||t-test, 2 sided|||||||1.0
71003017|NCT03053401|141513616|OTHER|Test of difference was conducted.||||||0.026|||||||Wilcoxon (Mann-Whitney)|||||||0.026
71003018|NCT03053401|141513617|OTHER|||||||0.762||||||Alpha = 0.025 for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.762
71003019|NCT03053401|141513617|OTHER|||||||0.41||||||Alpha = 0.025 for multiple comparisons.|Wilcoxon Rank Sum Test with Exact Option|||||||0.410
71003020|NCT03053401|141513618|OTHER|Test of Difference conducted.||||||0.454|||||||t-test, 2 sided|||||||0.454
71003021|NCT01804842|141513624|SUPERIORITY_OR_OTHER||% Ratio of LS Means|71.7||||0.0018|TWO_SIDED|90.0|61.14|84.01|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met DR qPM is the denominator for the % ratio of least squares (LS) means and the comparator for the p-values.||84.01|61.14|0.0018
71003022|NCT01804842|141513624|SUPERIORITY_OR_OTHER||% Ratio of LS Means|71.5||||0.002|TWO_SIDED|90.0|60.85|84.09|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||500 mg Met DR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||84.09|60.85|0.0020
71003023|NCT01804842|141513624|SUPERIORITY_OR_OTHER||% Ratio of LS Means|99.8||||0.9844|TWO_SIDED|90.0|84.91|117.33|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||500 mg Met DR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||117.33|84.91|0.9844
71003024|NCT01804842|141513625|SUPERIORITY_OR_OTHER||% Ratio of LS Means|83.8||||0.1595|TWO_SIDED|90.0|68.1|103.23|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met DR qPM is the denominator for the % ratio of LS means and the comparator for the p-values.||103.23|68.10|0.1595
71003025|NCT01804842|141513625|SUPERIORITY_OR_OTHER||% Ratio of LS Means|111.3||||0.3867|TWO_SIDED|90.0|90.37|136.99|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||500 mg Met DR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||136.99|90.37|0.3867
71003026|NCT01804842|141513625|SUPERIORITY_OR_OTHER||% Ratio of LS Means|132.7||||0.0294|TWO_SIDED|90.0|107.78|163.39|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||500 mg Met DR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||163.39|107.78|0.0294
71003027|NCT01804842|141513626|SUPERIORITY_OR_OTHER||% Ratio of LS Means|91.0||||0.0028|TWO_SIDED|95.0|85.7|96.67|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment\*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.||96.67|85.70|0.0028
71100960|NCT02732145|141709694|SUPERIORITY|Question: Is there a difference in the incidence of vulvar pain like sticking depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.8925|||||||Chi-squared|||Parameter: The incidence of the vulvar pain like sticking depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.8925
71100961|NCT02732145|141709695|SUPERIORITY|Question: Is there a difference in the incidence of vulvar complaints depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of vulvar complaints depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.0000
71100962|NCT02732145|141709695|SUPERIORITY|Question: Is there a difference in the incidence of symptoms of the dull pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.6921|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the dull (slow) pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.6921
71100963|NCT02732145|141709695|SUPERIORITY|Question: Is there a difference in the incidence of vulvar burning on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.1848|||||||Chi-squared|||Parameter: The incidence of vulvar burning depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.1848
71100964|NCT02732145|141709695|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.9048|||||||Chi-squared|||Parameter: The incidence of vulvar stinging depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.9048
71100965|NCT02732145|141709695|SUPERIORITY|Question: Is there a difference in the incidence of vulvar soreness depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.3953|||||||Chi-squared|||Parameter: The incidence of vulvar soreness depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.3953
71100966|NCT02732145|141709695|SUPERIORITY|Question: Is there a difference in the incidence of vulvar irritation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.0921|||||||Chi-squared|||Parameter: The incidence of vulvar irritation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.0921
71100967|NCT02732145|141709695|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.6734|||||||Chi-squared|||Parameter: The incidence of vulvar itching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.6734
71100968|NCT02732145|141709695|SUPERIORITY|Question: Is there a difference in the incidence of the feeling of vulvar inflammation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.3458|||||||Chi-squared|||Parameter: The incidence of the feeling of vulvar inflammation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.3458
71100969|NCT02732145|141709695|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.5304|||||||Chi-squared|||Parameter: The incidence of vulvar aching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.5304
71100970|NCT02732145|141709695|SUPERIORITY|Question: Is there a difference in the incidence of symptoms of the sharp pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.0012|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the sharp (fast) pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.0012
71100971|NCT02732145|141709695|SUPERIORITY|Question: Is there a difference in the incidence of vulvar knife-like pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.0002|||||||Chi-squared|||Parameter: The incidence of vulvar knife-like pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.0002
71100972|NCT02732145|141709695|SUPERIORITY|Question: Is there a difference in the incidence of vulvar paper-cuts pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.0218|||||||Chi-squared, Corrected|||Parameter: The incidence of vulvar paper-cuts pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.0218
71100973|NCT02732145|141709695|SUPERIORITY|Question: Is there a difference in the incidence of vulvar pain like stabbing depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.0297|||||||Chi-squared|||Parameter: The incidence of vulvar pain like stabbing depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.0297
71100974|NCT02732145|141709695|SUPERIORITY|Question: Is there a difference in the incidence of vulvar pain like sticking depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.6468|||||||Chi-squared|||Parameter: The incidence of vulvar pain like sticking depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.6468
71100975|NCT02732145|141709696|SUPERIORITY|Question: Is there a difference in the incidence of the finding of inflammatory infiltrates in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.2045|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of inflammatory infiltrates in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort.||||0.2045
71100976|NCT02732145|141709696|SUPERIORITY|Question: Is there a difference in the incidence of the finding of mononuclear inflammatory infiltrates in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.7469|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of mononuclear inflammatory infiltrates in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort.||||0.7469
71100977|NCT02732145|141709696|SUPERIORITY|Question: Is there a difference in the incidence of the finding of lymphocytes in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.4271|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of lymphocytes in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort.||||0.4271
71003028|NCT01804842|141513626|SUPERIORITY_OR_OTHER||% Ratio of LS Means|90.9||||0.0024|TWO_SIDED|95.0|85.58|96.53|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment\*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.||96.53|85.58|0.0024
71003029|NCT01804842|141513626|SUPERIORITY_OR_OTHER||% Ratio of LS Means|95.1||||0.0992|TWO_SIDED|95.0|89.54|100.99|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment\*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.||100.99|89.54|0.0992
71003030|NCT01804842|141513627|SUPERIORITY_OR_OTHER||% Ratio of LS Means|90.4||||0.0006|TWO_SIDED|95.0|85.55|95.56|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment\*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.||95.56|85.55|0.0006
71003031|NCT01804842|141513627|SUPERIORITY_OR_OTHER||% Ratio of LS Means|90.5||||0.0007|TWO_SIDED|95.0|85.65|95.67|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment\*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.||95.67|85.65|0.0007
71003032|NCT01804842|141513627|SUPERIORITY_OR_OTHER||% Ratio of LS Means|94.3||||0.0389|TWO_SIDED|95.0|89.24|99.69|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment\*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.||99.69|89.24|0.0389
71003033|NCT04222673|141513657|SUPERIORITY|Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||||0.05|||||||the Reliable Change Index|||||||.05
71003034|NCT04222673|141513658|SUPERIORITY|Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||||0.05|||||||the Reliable Change Index|||||||.05
71003035|NCT04222673|141513659|OTHER|||||||0.05|||||||the Reliable Change Index|||Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||.05
71003036|NCT04222673|141513660|SUPERIORITY|||||||0.05|||||||the Reliable Change Index|||Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||.05
70924634|NCT04321031|141342038|SUPERIORITY||Risk Difference (RD)|0.12|||||TWO_SIDED|90.0|-0.07|0.3||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.30|-0.07|
71003037|NCT04222673|141513661|SUPERIORITY|||||||0.05|||||||the Reliable Change Index|||Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||.05
71003038|NCT04222673|141513662|SUPERIORITY|Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||||0.05|||||||the Reliable Change Index|||||||.05
71043158|NCT01115855|141595187|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-144.6|STANDARD_ERROR_OF_MEAN|200.56|||TWO_SIDED|90.0|-2692.95|2403.76||||||Change from baseline at Month 42 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||2403.76|-2692.95|
71043159|NCT01115855|141595187|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-77.26|STANDARD_ERROR_OF_MEAN|966.09|||TWO_SIDED|95.0|-2131.88|1977.37||||||Change from baseline at Month 48 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||1977.37|-2131.88|
71043160|NCT01115855|141595187|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-102.3|STANDARD_ERROR_OF_MEAN|35.67|||TWO_SIDED|95.0|-172.61|-32.0||||||Change from baseline at Month 13 : ANCOVA with treatment effect and covariates of the NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-32.00|-172.61|
71003039|NCT04222673|141513663|SUPERIORITY|||||||0.05|||||||the Reliable Change Index|||Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||.05
71003040|NCT04222673|141513664|SUPERIORITY|||||||0.05|||||||the Reliable Change Index|||Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||.05
71003041|NCT00068822|141513669|SUPERIORITY_OR_OTHER||Adjusted treatment effect|0.7||||0.49|TWO_SIDED|95.0|-1.3|2.8|||ANCOVA|||Between group comparisons, confidence intervals, and P values were calculated with the use of analysis-of-covariance models with adjustment for study group assignment, baseline value of the outcome measure, and study center. Negative treatment effects favor the control procedure, and positive treatment effects favor vertebroplasty.||2.8|-1.3|0.49
71003042|NCT00068822|141513670|SUPERIORITY_OR_OTHER||Treatment Effect|1.0||||0.45|TWO_SIDED|95.0|-1.7|3.7|||ANCOVA|||SF-36 Physical Component Summary treatment effect||3.7|-1.7|0.45
71003043|NCT00068822|141513670|SUPERIORITY_OR_OTHER||Treatment Effect|1.0||||0.83|TWO_SIDED|95.0|-3.7|4.6|||ANCOVA|||SF-36 Mental Component Summary treatment effect||4.6|-3.7|0.83
71003044|NCT00068822|141513670|SUPERIORITY_OR_OTHER||Treatment Effect|0.2||||0.33|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Pain Frequency Index treatment effect||0.6|-0.2|0.33
71003045|NCT00068822|141513670|SUPERIORITY_OR_OTHER||Treatment Effect|0.33||||0.33|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Pain Bothersome Index treatment effect||0.6|-0.2|0.33
71003046|NCT00068822|141513670|SUPERIORITY_OR_OTHER||Treatment Effect|0.05||||0.13|TWO_SIDED|95.0|-0.01|0.11|||ANCOVA|||EQ-5D Index treatment effect||0.11|-0.01|0.13
71100978|NCT02732145|141709696|SUPERIORITY|Question: Is there a difference in the incidence of the finding of collagen fibers in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.3607|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of collagen fibers in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort.||||0.3607
71100979|NCT02732145|141709696|SUPERIORITY|Question: Is there a difference in the incidence of the finding of hyalinization in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.8672|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of hyalinization in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort.||||0.8672
71003047|NCT00068822|141513670|SUPERIORITY_OR_OTHER||Treatment Effect|0.4||||0.5|TWO_SIDED|95.0|-0.8|1.6|||ANCOVA|||SOF-ADL treatment effect||1.6|-0.8|0.5
71003048|NCT00068822|141513671|SUPERIORITY_OR_OTHER||Adjusted treatment effect|0.7||||0.19|TWO_SIDED|95.0|-0.3|1.7|||ANCOVA|||Between group comparisons, confidence intervals, and P values were calculated with the use of analysis-of-covariance models with adjustment for study group assignment, baseline value of the outcome measure, and study center. Negative treatment effects favor the control procedure, and positive treatment effects favor vertebroplasty.||1.7|-0.3|0.19
71043161|NCT01115855|141595188|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-364.65|STANDARD_ERROR_OF_MEAN|763.83|||TWO_SIDED|95.0|-1863.06|1133.76||||||Change from baseline at Month 5 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||1133.76|-1863.06|
71100980|NCT02732145|141709697|SUPERIORITY|Question: Is there a difference in the incidence of the finding of inflammatory infiltrates in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.0045|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of inflammatory infiltrates in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.0045
71003049|NCT00617162|141513677|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.3989|TWO_SIDED|95.0|-5.5|2.2|||Fisher Exact|||||2.2|-5.5|0.3989
71003050|NCT00735072|141513686|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||95.0|||||Wilcoxon (Mann-Whitney)|||Null hypothesis: there will be no difference in the week 24 change in %activated CD8+ T cells between arms. Assuming a standard deviation as high as 3.5% and a Type I error of 5%, with 21 subjects in each treatment arm we would have 80% statistical power to detect a mean 3 percentage-point difference in the percent of activated CD8+ T cells between the active drug and placebo groups.||||0.014
71003051|NCT00735072|141513687|OTHER|||||||0.97|||||||Mixed Models Analysis|||||||0.97
71003052|NCT00735072|141513688|OTHER|||||||0.33|||||||Mixed Models Analysis|||||||0.33
71003053|NCT03241589|141513742|SUPERIORITY||Odds Ratio (OR)|0.931||||0.7428|TWO_SIDED|95.0|0.606|1.429|||Regression, Logistic||Referent group is Urban|We followed power calculations described in uploaded protocol document, using an incomplete design matrix with a 3-month transition period, a level of precision α=0.05 and a minimum power level of 0.80. We also assumed a total number of clusters I=36 as per the study design and the number of baseline measurements B=2. Due to insufficient sample size, we modified groups studied.||1.429|0.606|0.7428
71003054|NCT03241589|141513743|SUPERIORITY||Odds Ratio (OR)|2.258||||0.0031|TWO_SIDED|95.0|1.181|4.315|||Regression, Logistic|2 degrees of freedom, Wald Chi-Square 11.5759|Veterans with expired requests = referent.|||4.315|1.181|0.0031
71043162|NCT01115855|141595188|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-247.14|STANDARD_ERROR_OF_MEAN|711.26|||TWO_SIDED|95.0|-1642.43|1148.14||||||Change from baseline at Month 9 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||1148.14|-1642.43|
71003055|NCT02972593|141513748|OTHER|Data collapsed to participant level, creating an ever/never response for each participant for each infection outcome type. Analyses performed at the participant level to determine if proportion of outcome types were similar between transfusion groups using Fisher's Exact tests, due to small expected cell counts, using SAS v9.4 (SAS Institute, Cary, NC). Power analyses performed based on these proportions using bootstrapping methods in SAS and confirmed with nQuery v8.7.1.0.||||||0.0122|||||||Fisher Exact|||||||.0122
71100981|NCT02732145|141709697|SUPERIORITY|Question: Is there a difference in the incidence of the finding of mononuclear inflammatory infiltrates in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.0032|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of mononuclear inflammatory infiltrates in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.0032
71003056|NCT02972593|141513749|OTHER|||||||0.7742|||||||Fisher Exact|||||||.7742
71003057|NCT02972593|141513750|OTHER|||||||0.1443|||||||t-test, 1 sided|||||||.1443
71003058|NCT04599972|141513751|SUPERIORITY||Odds Ratio (OR)|2.979|||<|0.01|TWO_SIDED|95.0|1.753|5.064|||Regression, Logistic|||All treatment comparisons for primary and secondary endpoints related to BDCVA were conducted with a logistic regression model including fixed effects of baseline BDCVA at 40 cm as a covariate and treatment.||5.064|1.753|<0.01
71003059|NCT04599972|141513752|SUPERIORITY||Odds Ratio (OR)|2.807|||<|0.01|TWO_SIDED|95.0|1.655|4.762|||Regression, Logistic|||||4.762|1.655|<0.01
71003060|NCT04599972|141513753|SUPERIORITY||Odds Ratio (OR)|6.002|||<|0.01|TWO_SIDED|95.0|3.431|10.499|||Regression, Logistic|||||10.499|3.431|<0.01
71003061|NCT04599972|141513754|SUPERIORITY||Odds Ratio (OR)|4.161|||<|0.01|TWO_SIDED|95.0|2.404|7.204|||Regression, Logistic|||||7.204|2.404|<0.01
71003062|NCT03949621|141513755|OTHER|Geometric least-squares means (LSMs) were calculated by exponentiating the LSMs derived from analysis of covariance (ANCOVA) with weight as a covariate. Confidence intervals (CIs) were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|0.9632|||||TWO_SIDED|90.0|0.7938|1.1688||||||||1.1688|0.7938|
71003063|NCT03949621|141513756|OTHER|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|0.9606|||||TWO_SIDED|90.0|0.798|1.1562||||||||1.1562|0.798|
71003064|NCT03949621|141513757|OTHER|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|1.0162|||||TWO_SIDED|90.0|0.9001|1.1473||||||||1.1473|0.9001|
71003065|NCT00638690|141513758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.646|||<|0.0001|TWO_SIDED|95.0|0.543|0.768||Nominal P-value is 0.0142 at interim analysis based on group sequential design.|Log Rank|This was a stratified analysis.||||0.768|0.543|<0.0001
71003066|NCT00638690|141513759|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.0001||95.0|0.462|0.728||Nominal P-value = 0.05.|Log Rank|This was a stratified analysis.||||0.728|0.462|<0.0001
71003067|NCT00638690|141513760|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|5.266|||<|0.001|TWO_SIDED|95.0|3.459|8.018||Nominal P-value = 0.05.|Chi-squared|||||8.018|3.459|<0.001
71003068|NCT00638690|141513761|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.673|||<|0.0001|TWO_SIDED|95.0|0.585|0.776||The nominal P-value = 0.05.|Log Rank|This was a stratified analysis.||||0.776|0.585|<0.0001
71003069|NCT01378299|141513804|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with last value carry forward.||||<0.05
71003070|NCT01378299|141513805|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward||||<0.05
71003071|NCT01378299|141513806|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
71003072|NCT01378299|141513807|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
71003073|NCT01378299|141513808|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
71003074|NCT01378299|141513809|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
71003075|NCT01378299|141513810|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
71003076|NCT01378299|141513812|OTHER||||||<|0.05|||||||ANOVA|||Analysis was by intention to treat with the last value carry forward. Those who had at least one follow-up from baseline and with acceptable assay coefficient of variability were included in the analysis. The data of 79 subjects were analyzed; 15 in the GG, 43 in the GA and 21 in the AA genotype.||||<0.05
71003077|NCT01378299|141513813|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
71003078|NCT01378299|141513814|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
71003079|NCT01378299|141513815|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
71003080|NCT01448707|141513820|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DRV/rtv monotherapy versus triple therapy was assessed with a maximum allowable difference of 12 percent (%), with a one-sided significance level of 2.5%.|Non-Linear mixed|-7.9||||0.2331|TWO_SIDED|95.0|-14.64|-1.19||P-Value for non-inferiority of DRV/rtv MONO vs DRV/rtv + 2NRTIs (delta = 12%).|Mixed Models Analysis|Predicted response rate:confidence limits are obtained by means of logistic regression model with treatment group and Hepatitis C status as covariates||||-1.19|-14.64|0.2331
71003081|NCT01448707|141513821|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DRV/rtv monotherapy versus triple therapy was assessed with a maximum allowable difference of 12 percent (%), with a one-sided significance level of 2.5% and 80% power.|Non-Linear mixed|-10.1||||0.6933|TWO_SIDED|95.0|-19.5|-0.73|||Mixed Models Analysis|||||-0.73|-19.50|0.6933
71003082|NCT01448707|141513822|NON_INFERIORITY_OR_EQUIVALENCE|Week 48: Non-inferiority of DRV/rtv monotherapy versus triple therapy was assessed with a maximum allowable difference of 12 percent (%), with a one-sided significance level of 2.5% and 80% power.|Non-linear mixed model|-3.5||||0.0016|TWO_SIDED|95.0|-8.77|1.72|||Mixed Models Analysis|||||1.72|-8.77|0.0016
71003083|NCT01448707|141513822|NON_INFERIORITY_OR_EQUIVALENCE|Week 96: Non-inferiority of DRV/rtv monotherapy versus triple therapy was assessed with a maximum allowable difference of 12 percent (%), with a one-sided significance level of 2.5% and 80% power.|non-linear mixed model|-0.7||||0.0022|TWO_SIDED|95.0|-7.89|6.58|||Mixed Models Analysis|||||6.58|-7.89|0.0022
71003084|NCT02667392|141513827|OTHER|||||||0.77||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.77
71003085|NCT02667392|141513828|OTHER|||||||0.61||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.61
71003086|NCT02667392|141513829|OTHER|||||||0.28||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.28
71003087|NCT02667392|141513830|OTHER|||||||0.002||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.002
71100982|NCT02732145|141709697|SUPERIORITY|Question: Is there a difference in the incidence of the finding of collagen fibers in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.1067|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of collagen fibers in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.1067
71003088|NCT02667392|141513831|OTHER|||||||0.02||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.02
71003089|NCT02667392|141513832|OTHER|||||||0.03||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.03
71003090|NCT02667392|141513833|OTHER|||||||0.55||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.55
71003091|NCT02667392|141513834|OTHER|a priori threshold for statistical significance set at p \< 0.05||||||0.0089|||||||t-test, 2 sided|||||||0.0089
71003092|NCT02667392|141513835|OTHER|a priori threshold for statistical significance set at p \< 0.05||||||0.73|||||||t-test, 2 sided|||||||0.73
71003093|NCT02667392|141513836|OTHER|a priori threshold for statistical significance set at p \< 0.05||||||0.81|||||||t-test, 2 sided|||||||0.81
71003094|NCT02667392|141513837|OTHER|||||||0.02||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.02
71003095|NCT01810380|141513840|SUPERIORITY_OR_OTHER||Least square mean difference|-4.1|STANDARD_ERROR_OF_MEAN|2.1||0.056|TWO_SIDED|95.0|-8.2|0.1||For all efficacy analyses the primary comparison is the difference between brexpiprazole 2 to 4 mg/day and placebo at Week 6.|Mixed Models Analysis|Pooled site, visit, treatment as fixed effects, baseline score as continuous covariate, treatment-by-visit and baseline score-by-visit as interactions||The overall significance level was 0.05. The primary and the key secondary endpoints were tested hierarchically. Only if the primary endpoint was statistically significant would confirmatory testing continue with the key secondary endpoint.||0.1|-8.2|0.0560
71003096|NCT01810380|141513840|SUPERIORITY_OR_OTHER||Least square mean difference|-8.0|STANDARD_ERROR_OF_MEAN|2.1||0.0002|TWO_SIDED|95.0|-12.2|-3.9|||Mixed Models Analysis|||||-3.9|-12.2|0.0002
71003097|NCT02623699|141513878|SUPERIORITY||least square (LS) mean difference|1.2|STANDARD_ERROR_OF_MEAN|2.22|=|0.9689|TWO_SIDED|95.0|-3.19|5.53||Joint rank p-value was calculated from ANCOVA model which included treatment as fixed effect, adjusts for covariates: Baseline disease duration since symptom onset, baseline ALSFRS-R total score, and use of riluzole or edaravone.|Joint rank||ANCOVA model included treatment as a fixed effect, adjusts for the covariates: Baseline disease duration since symptom onset, baseline ALSFRS-R total score, and use of riluzole or edaravone.|Joint rank test combining function and mortality were used for statistical inference and the estimates were from the Analysis of covariance (ANCOVA) for change from baseline. Multiple imputation was used to handle missing data for withdrawals other than death in the joint rank analysis. Multiple imputation was used to handle all missing data in the ANCOVA for change from baseline.||5.53|-3.19|= 0.9689
71003098|NCT02623699|141513879|SUPERIORITY||Difference in LS geometric mean ratio|0.67|||<|0.0001|TWO_SIDED|95.0|0.53|0.84|||Wilcoxon rank sum test|||Difference in LS geometric mean ratio (BIIB067:Placebo) was calculated.||0.84|0.53|< 0.0001
71043163|NCT01115855|141595188|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-370.14|STANDARD_ERROR_OF_MEAN|699.58|||TWO_SIDED|95.0|-1742.51|1002.22||||||Change from baseline at Month 13 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||1002.22|-1742.51|
71043164|NCT01115855|141595188|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-664.09|STANDARD_ERROR_OF_MEAN|11059.62|||TWO_SIDED|95.0|-141189.93|139861.75||||||Change from baseline at Month 17 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||139861.75|-141189.93|
71043165|NCT01115855|141595188|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-414.99|STANDARD_ERROR_OF_MEAN|3071.77|||TWO_SIDED|95.0|-39445.52|38615.54||||||Change from baseline at Month 21 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||38615.54|-39445.52|
71043166|NCT01115855|141595188|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|23.86|STANDARD_ERROR_OF_MEAN|10794.85|||TWO_SIDED|95.0|-21649.89|21697.6||||||Change from baseline at Month 25 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||21697.60|-21649.89|
71043167|NCT01115855|141595188|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-245.23|STANDARD_ERROR_OF_MEAN|6698.57|||TWO_SIDED|95.0|-85358.69|84868.22||||||Change from baseline at Month 29 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||84868.22|-85358.69|
71100983|NCT02732145|141709697|SUPERIORITY|Question: Is there a difference in the incidence of inflammatory cells in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.8672|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of hyalinization in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.8672
71100984|NCT02732145|141709697|SUPERIORITY|Question: Is there a difference in the incidence of blood vessels in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.0219|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of blood vessels in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.0219
71043168|NCT01115855|141595188|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|170.49|STANDARD_ERROR_OF_MEAN|10730.38|||TWO_SIDED|95.0|-21375.69|21716.66||||||Change from baseline at Month 33 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||21716.66|-21375.69|
71100985|NCT02732145|141709697|SUPERIORITY|Question: Is there a difference in the incidence of sebaceous glands in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.8213|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of sebaceous glands in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.8213
71100986|NCT02732145|141709697|SUPERIORITY|Question: Is there a difference in the incidence of the finding of nerve fibers in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.0613|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of nerve fibers in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.0613
71100987|NCT01837550|141709700|NON_INFERIORITY_OR_EQUIVALENCE|To ensure a between-group effect of 80% at the 5% significance level it was estimated that 60 participants need to be included in the study. An effect size of Cohen's d=0.80 was expected. The expected standardized mean difference on the HHIE formed the basis for the obtained power.||||||0.685|||||||Mixed Models Analysis|||||||0.685
71100988|NCT04191733|141709710|NON_INFERIORITY|The non-inferiority analysis was demonstrated when the 1-sided upper 95% confidence interval (CI) limit was less than 1.25.|||||<|0.0001||||||one-sided p-value|t-test, 1 sided|||||||<0.0001
71043169|NCT01115855|141595188|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-58.77|STANDARD_ERROR_OF_MEAN|12765.3|||TWO_SIDED|95.0|-30160.25|30042.7||||||Change from baseline at Month 37 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||30042.70|-30160.25|
71043170|NCT01115855|141595188|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-212.25|STANDARD_ERROR_OF_MEAN|11073.11|||TWO_SIDED|90.0|-22723.82|22299.33||||||Change from baseline at Month 42 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||22299.33|-22723.82|
71043171|NCT01115855|141595188|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-80.16|STANDARD_ERROR_OF_MEAN|11486.21|||TWO_SIDED|95.0|-146026.28|145865.96||||||Change from baseline at Month 48 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||145865.96|-146026.28|
71043172|NCT01115855|141595188|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-187.72|STANDARD_ERROR_OF_MEAN|240.96|||TWO_SIDED|95.0|-662.67|287.23||||||Change from baseline at Month 13 : ANCOVA with treatment effect and covariates of the NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||287.23|-662.67|
71003099|NCT02623699|141513879|SUPERIORITY||Difference in LS geometric mean ratio|0.75|||=|0.0002|TWO_SIDED|95.0|0.6|0.95|||Wilcoxon rank sum test|||Difference in LS geometric mean ratio (BIIB067:Placebo) was calculated.||0.95|0.60|=0.0002
71043173|NCT01115855|141595189|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.71|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|95.0|-0.55|3.96||||||Change from baseline at Month 5 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||3.96|-0.55|
71043174|NCT01115855|141595189|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|2.74|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|95.0|0.07|5.42||||||Change from baseline at Month 9 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||5.42|0.07|
71043175|NCT01115855|141595189|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.86|STANDARD_ERROR_OF_MEAN|1.39|||TWO_SIDED|95.0|1.11|6.6||||||Change from baseline at Month 13 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||6.60|1.11|
71043176|NCT01115855|141595189|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|4.86|STANDARD_ERROR_OF_MEAN|1.54|||TWO_SIDED|95.0|1.81|7.9||||||Change from baseline at Month 17 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||7.90|1.81|
71043177|NCT01115855|141595189|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|5.65|STANDARD_ERROR_OF_MEAN|1.67|||TWO_SIDED|95.0|2.36|8.94||||||Change from baseline at Month 21 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||8.94|2.36|
71043178|NCT01115855|141595189|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.44|STANDARD_ERROR_OF_MEAN|1.68|||TWO_SIDED|95.0|0.12|6.75||||||Change from baseline at Month 25 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||6.75|0.12|
71003100|NCT02623699|141513879|SUPERIORITY||Difference in LS geometric mean ratio|0.81|||=|0.0641|TWO_SIDED|95.0|0.65|1.02|||Wilcoxon rank sum test|||Difference in LS geometric mean ratio (BIIB067:Placebo) was calculated.||1.02|0.65|=0.0641
71003101|NCT02623699|141513879|SUPERIORITY||Difference in LS geometric mean ratio|0.67|||<|0.0001|TWO_SIDED|95.0|0.53|0.84|||Wilcoxon rank sum test|||Difference in LS geometric mean ratio (BIIB067:Placebo) was calculated.||0.84|0.53|<0.0001
71003102|NCT02623699|141513880|SUPERIORITY||Difference in LS geometric mean ratio|0.62|||<|0.0001|TWO_SIDED|95.0|0.49|0.78||The analysis was based on ANCOVA model with natural log transformed data. P-value for this secondary outcome measure (OM) is nominal as statistical significance was not met on the primary OM.|ANCOVA|||The ANCOVA model included covariates for the corresponding baseline value i.e. log value, baseline disease duration since symptom onset, and use of riluzole or edaravone. Multiple imputation was used to handle missing data for withdrawals. Difference in LS geometric mean ratio to baseline (BIIB067:Placebo) was calculated.||0.78|0.49|< 0.0001
71100989|NCT04191733|141709711|NON_INFERIORITY|1-sided test with 5% alpha was used to demonstrate non-inferiority with greater than 99% power. The non-inferiority margin was 3.75 minutes.||||||0.1004|||||||t-test, 1 sided|||A gatekeeping strategy was used to control family-wise type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The testing sequence continued only when previous endpoint was statistically significant with a 1-sided alpha of 0.05.||||0.1004
71003103|NCT02623699|141513881|SUPERIORITY||Difference in LS geometric mean ratio|0.33|||<|0.0001|TWO_SIDED|95.0|0.25|0.45||The analysis was based on ANCOVA model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, baseline disease duration since symptom onset, and use of riluzole or edaravone.|ANCOVA|P-value for this secondary OM is nominal as statistical significance was not met on the primary OM.||Difference in LS geometric mean ratio (BIIB067:Placebo) was calculated.||0.45|0.25|< 0.0001
71043179|NCT01115855|141595189|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.6|STANDARD_ERROR_OF_MEAN|1.85|||TWO_SIDED|95.0|-0.06|7.25||||||Change from baseline at Month 29 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||7.25|-0.06|
71043180|NCT01115855|141595189|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|4.65|STANDARD_ERROR_OF_MEAN|1.92|||TWO_SIDED|95.0|0.86|8.44||||||Change from baseline at Month 33 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||8.44|0.86|
71043181|NCT01115855|141595189|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.85|STANDARD_ERROR_OF_MEAN|1.94|||TWO_SIDED|95.0|0.02|7.68||||||Change from baseline at Month 37 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||7.68|0.02|
71043182|NCT01115855|141595189|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|4.67|STANDARD_ERROR_OF_MEAN|2.31|||TWO_SIDED|90.0|0.08|9.25||||||Change from baseline at Month 42 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||9.25|0.08|
71043183|NCT01115855|141595189|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|4.13|STANDARD_ERROR_OF_MEAN|2.98|||TWO_SIDED|95.0|-1.82|10.07||||||Change from baseline at Month 48 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||10.07|-1.82|
71003104|NCT02623699|141513882|SUPERIORITY||LS mean difference|7.9|STANDARD_ERROR_OF_MEAN|5.829|=|0.3233|TWO_SIDED|95.0|-3.528|19.322||Joint rank p-value was calculated from ANCOVA model which included treatment as fixed effect, adjusts for covariates: Baseline disease duration since symptom onset, baseline ALSFRS-R total score, baseline SVC, and use of riluzole or edaravone.|Joint rank|P-value for this secondary OM is nominal as statistical significance was not met on the primary OM.|ANCOVA model included treatment as a fixed effect, adjusts for the covariates: Baseline disease duration since symptom onset, baseline ALSFRS-R total score, baseline SVC, and use of riluzole or edaravone.|Joint rank test combining function and mortality were used for statistical inference and the estimates were from the ANCOVA for change from baseline. Multiple imputation was used to handle missing data for withdrawals other than death in the joint rank analysis. Multiple imputation was used to handle all missing data in the ANCOVA for change from baseline.||19.322|-3.528|= 0.3233
71003105|NCT02623699|141513883|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.118|=|0.839|TWO_SIDED|95.0|-0.207|0.255||ANCOVA model included treatment as fixed effect and adjusts for following covariates: Baseline disease duration since symptom onset, baseline HHD overall megascore, and use of riluzole/edaravone. Missing data were handled using multiple imputation.|ANCOVA|P-value for this secondary OM is nominal as statistical significance was not met on the primary OM.||||0.255|-0.207|= 0.8390
71003106|NCT02579863|141513915|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.33475|TWO_SIDED|95.0|0.56|1.45|||Log Rank|One-sided p-value based on Stratified log-rank test.|Based on Cox regression model with treatment as a covariate stratified by Age (\<75 years vs \>= 75 years) and ISS stage (I or II vs. III).|||1.45|0.56|0.33475
71003107|NCT02579863|141513916|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.83416|TWO_SIDED|95.0|0.81|1.84|||Stratified log-rank test||"Based on Cox regression model with treatment as a covariate stratified by Age (\<75 years vs \>= 75 years) and ISS stage (I or II vs. III)."|||1.84|0.81|0.83416
71003108|NCT02579863|141513917|SUPERIORITY||Difference in % vs SOC|5.8||||0.13102|TWO_SIDED|95.0|-4.3|15.8|||One-sided p-value for testing|H0: difference in % =0 versus H1: difference in % \> 0.|||Based on Miettinen \& Nurminen method stratified by 'Age' (\<75 years vs \>= 75 years) and 'ISS stage' (I or II vs. III); If there were no participants in one of the treatment groups involved in a comparison for a particular stratum, then that stratum was excluded from the treatment comparison.|15.8|-4.3|0.13102
71003109|NCT04323098|141513942|SUPERIORITY|||||||0.0057||||||P-value was based on two-sided t-test against 0.|t-test, 2 sided|||||||0.0057
71003110|NCT02352090|141513950|OTHER|||||||0.27|||||||ANOVA|||||||0.27
71003111|NCT01849562|141513961|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|50.0|||||TWO_SIDED|95.0|1.8|82.7||||||Differences in proportions between Group 1 (sovaprevir 200 mg plus ACH-3102 150/50 mg plus RBV) and overall placebo (placebo from Group 1 and Group 2 combined) along with corresponding 95% confidence intervals for risk difference calculated using exact unconditional methods were obtained.||82.7|1.8|
71043184|NCT01115855|141595189|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.18|STANDARD_ERROR_OF_MEAN|1.33|||TWO_SIDED|95.0|0.56|5.8||||||Change from baseline at Month 13 : ANCOVA with treatment effect and covariates of the NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||5.80|0.56|
71003112|NCT01849562|141513961|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|70.0|||||TWO_SIDED|95.0|24.2|93.6||||||Differences in proportions between Group 2 (sovaprevir 400 mg plus ACH-3102 150/50 mg plus RBV) and overall placebo (placebo from Group 1 and Group 2 combined) along with corresponding 95% confidence intervals for risk difference calculated using exact unconditional methods were obtained.||93.6|24.2|
71003113|NCT03146403|141513963|SUPERIORITY|||||||0.7474|||||||Wilcoxon (Mann-Whitney)|||||||0.7474
71003114|NCT03146403|141513964|SUPERIORITY|||||||0.645|||||||Wilcoxon (Mann-Whitney)|||||||0.6450
71003115|NCT03146403|141513965|SUPERIORITY|||||||0.3157|||||||Chi-squared|||||||0.3157
71043185|NCT01115855|141595190|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-61.53|STANDARD_ERROR_OF_MEAN|59.75|||TWO_SIDED|95.0|-186.44|63.37||||||Change from baseline at Month 5: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||63.37|-186.44|
71043186|NCT01115855|141595190|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-24.94|STANDARD_ERROR_OF_MEAN|54.2|||TWO_SIDED|95.0|-131.27|81.39||||||Change from baseline at Month 9 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||81.39|-131.27|
71043187|NCT01115855|141595190|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-12.57|STANDARD_ERROR_OF_MEAN|43.18|||TWO_SIDED|95.0|-97.28|72.13||||||Change from baseline at Month 13 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||72.13|-97.28|
71043188|NCT01115855|141595190|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-78.47|STANDARD_ERROR_OF_MEAN|72.78|||TWO_SIDED|95.0|-221.25|64.31||||||Change from baseline at Month 17 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||64.31|-221.25|
71043189|NCT01115855|141595190|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-79.63|STANDARD_ERROR_OF_MEAN|67.42|||TWO_SIDED|95.0|-211.88|52.63||||||Change from baseline at Month 21 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||52.63|-211.88|
71100990|NCT00928720|141709730|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.045|TWO_SIDED||||||Mixed Models Analysis|||||||0.045
71100991|NCT02349477|141709736|SUPERIORITY||Odds Ratio (OR)|3.9||||0.028|TWO_SIDED||||||Regression, Logistic|This is the p-value output from the logistic regression model where medication group predicted the discrete variable for no heavy drinking days.||This analysis compares between Gabapentin and Placebo, the number of individuals who reported no heavy drinking days throughout the entire trial, corrected for %dCDT.||||.028
71003116|NCT03146403|141513966|SUPERIORITY|||||||0.3869|||||||Log Rank|||||||0.3869
71003117|NCT03146403|141513967|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.2200
71003118|NCT02182999|141513977|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.596|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||A sample size of 17 patients in each group was previously calculated on the basis of a significance level of .05, a power of 80%, an anticipated pooled standard Deviation (SD) of 1.0 of the mean verbal NRS pain level, and a minimal clinically important difference in the mean verbal NRS pain level of 1.0 points between the groups. Anticipating a loss to follow-up, we planned to recruit a total of 50 patients (25 patients each group).||||0.596
71003119|NCT02182999|141513978|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.353|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.353
71003120|NCT01791465|141514008|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
71003121|NCT01791465|141514009|SUPERIORITY_OR_OTHER|||||||0.34||||||Unadjusted - this was a Wilcoxon signed rank p-value (Baseline vs. week 16) comparison|Wilcoxon (Mann-Whitney)|no adjustments||The null hypothesis was that there would be no difference between baseline and 16 week IL-6||||0.34
71003122|NCT01791465|141514010|SUPERIORITY_OR_OTHER|||||||0.046|||||||Wilcoxon (Mann-Whitney)|||||||0.046
71003123|NCT01791465|141514011|SUPERIORITY_OR_OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.92
71003124|NCT01791465|141514012|SUPERIORITY_OR_OTHER|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
71003125|NCT01791465|141514013|SUPERIORITY_OR_OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
71003126|NCT01791465|141514014|SUPERIORITY_OR_OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.92
71003127|NCT01791465|141514015|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
71003128|NCT01791465|141514016|SUPERIORITY_OR_OTHER|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.60
71003129|NCT01791465|141514017|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
71003130|NCT01791465|141514018|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
71003131|NCT01791465|141514019|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
71003132|NCT01791465|141514020|SUPERIORITY_OR_OTHER|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
71043190|NCT01115855|141595190|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|19.35|STANDARD_ERROR_OF_MEAN|88.95|||TWO_SIDED|95.0|-230.01|268.71||||||Change from baseline at Month 25 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||268.71|-230.01|
71043191|NCT01115855|141595190|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-21.05|STANDARD_ERROR_OF_MEAN|88.27|||TWO_SIDED|95.0|-194.21|152.11||||||Change from baseline at Month 29: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||152.11|-194.21|
71043192|NCT01115855|141595190|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-40.79|STANDARD_ERROR_OF_MEAN|79.91|||TWO_SIDED|95.0|-197.55|115.97||||||Change from baseline at Month 33: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||115.97|-197.55|
71043193|NCT01115855|141595190|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-44.48|STANDARD_ERROR_OF_MEAN|103.29|||TWO_SIDED|95.0|-247.11|158.15||||||Change from baseline at Month 37 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||158.15|-247.11|
71003133|NCT01791465|141514021|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.50
71003134|NCT01791465|141514022|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
71003135|NCT01791465|141514023|SUPERIORITY_OR_OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
71003136|NCT01791465|141514024|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.75
71003137|NCT01791465|141514025|SUPERIORITY_OR_OTHER|||||||0.046|||||||Wilcoxon (Mann-Whitney)|||||||0.046
71003138|NCT01791465|141514026|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
71003139|NCT01791465|141514027|SUPERIORITY_OR_OTHER|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
71003140|NCT01791465|141514028|SUPERIORITY_OR_OTHER|||||||0.046|||||||Wilcoxon (Mann-Whitney)|||||||0.046
71003141|NCT02736929|141514040|SUPERIORITY||Mean Difference (Final Values)|9.8||||0.12|TWO_SIDED|95.0|-2.7|22.3|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up||22.3|-2.7|0.12
71003142|NCT02736929|141514041|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.024|TWO_SIDED|95.0|0.1|0.5|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||0.5|0.1|0.024
71003143|NCT02736929|141514042|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.027|TWO_SIDED|95.0|0.0|0.6|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||0.6|0.0|0.027
71003144|NCT02736929|141514043|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.024|TWO_SIDED|95.0|0.5|7.1|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||7.1|0.5|0.024
71003145|NCT02736929|141514044|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.19|TWO_SIDED|95.0|-9.8|2.0|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||2.0|-9.8|0.19
71003146|NCT02736929|141514045|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.31|TWO_SIDED|95.0|-1.3|0.4|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||0.4|-1.3|0.31
71003147|NCT02736929|141514046|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.86|TWO_SIDED|95.0|-1.8|1.5|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||1.5|-1.8|0.86
71003148|NCT02736929|141514047|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.77|TWO_SIDED|95.0|-1.7|1.2|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||1.2|-1.7|0.77
71003149|NCT00926185|141514050|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|0.06||||0.9381|TWO_SIDED|95.0|-0.26|0.39|||Dunnett's test||Analysis of covariance model with treatment, baseline, and site.|||0.39|-0.26|0.9381
71003150|NCT00926185|141514050|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|0.2||||0.3585|TWO_SIDED|95.0|-0.13|0.53|||Dunnett's test||Analysis of covariance model with treatment, baseline, and site.|||0.53|-0.13|0.3585
71100992|NCT02349477|141709737|SUPERIORITY||Odds Ratio (OR)|4.9||||0.053|TWO_SIDED||||||Regression, Logistic|This is the p-value output from the logistic regression model where medication group predicted the discrete variable for abstinence.||This analysis compares between Gabapentin and Placebo, the number of individuals who reported no drinking days (abstinence) throughout the entire trial, corrected for %dCDT.||||.053
71100993|NCT02349477|141709738|SUPERIORITY|||||||0.001|||||||Chi-squared|||For the High AWS group, a chi squared analysis compares the number of individuals with no heavy drinking days between medication groups.||||.001
71100994|NCT02349477|141709738|SUPERIORITY|||||||0.67|||||||Chi-squared|||For the Low AWS group, a chi squared analysis compares the number of individuals with no heavy drinking days between medication groups.||||.67
71100995|NCT01714063|141709739|OTHER|We used a paired T-test for statistical analysis to compare the filter dose. Using the 1% significance level and assuming a between-subject standard deviation of 60 lg (27%) for the difference between coordinated and doses, 32 subjects are sufficient to detect a 45 lg (20%) difference with 95% confidence.uncoordinated filter|||||<|0.001|||||||paired t-test|||||||<0.001
71100996|NCT02633527|141709747|SUPERIORITY||Mean Difference (Final Values)|-6.2||||0.0899|TWO_SIDED|95.0|-13.4|1.0|||ANOVA|||||1.0|-13.4|0.0899
71100997|NCT02633527|141709747|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.031|TWO_SIDED|95.0|-15.1|-0.7|||ANOVA|||||-0.7|-15.1|0.0310
71100998|NCT02633527|141709747|SUPERIORITY||Mean Difference (Final Values)|-8.1||||0.0268|TWO_SIDED|95.0|-15.3|-0.9|||ANOVA|||||-0.9|-15.3|0.0268
71100999|NCT02633527|141709747|SUPERIORITY||Mean Difference (Final Values)|-8.5||||0.0209|TWO_SIDED|95.0|-15.8|-1.3|||ANOVA|||||-1.3|-15.8|0.0209
71101000|NCT02633527|141709748|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.1305|TWO_SIDED|95.0|-1.0|0.1|||ANOVA|||||0.1|-1.0|0.1305
71101001|NCT02633527|141709748|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.1376|TWO_SIDED|95.0|-1.0|0.1|||ANOVA|||||0.1|-1.0|0.1376
71101002|NCT02633527|141709748|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.009|TWO_SIDED|95.0|-1.3|-0.2|||ANOVA|||||-0.2|-1.3|0.0090
71101003|NCT02633527|141709748|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.0546|TWO_SIDED|95.0|-1.1|0.0|||ANOVA|||||0.0|-1.1|0.0546
71101004|NCT02633527|141709749|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.0708|TWO_SIDED|95.0|-1.3|0.1|||ANCOVA|||||0.1|-1.3|0.0708
71101005|NCT02633527|141709749|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.0309|TWO_SIDED|95.0|-1.4|-0.1|||ANCOVA|||||-0.1|-1.4|0.0309
71101006|NCT02633527|141709749|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.0148|TWO_SIDED|95.0|-1.5|-0.2|||ANCOVA|||||-0.2|-1.5|0.0148
71101007|NCT02633527|141709749|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.0136|TWO_SIDED|95.0|-1.6|-0.2|||ANCOVA|||||-0.2|-1.6|0.0136
71101008|NCT04135443|141709756|SUPERIORITY||Odds Ratio (OR)|1.027||||0.94|TWO_SIDED|95.0|0.511|2.063|||Regression, Logistic|||||2.063|0.511|0.94
71101009|NCT04135443|141709758|SUPERIORITY||Slope|0.064||||0.455|TWO_SIDED|||||Threshold set to p\<0.05.|Regression, Linear|See analysis plan for covariates screened into model.||||||0.455
71101010|NCT04135443|141709759|SUPERIORITY||Slope|0.026||||0.702|TWO_SIDED|||||Threshold set to p\<0.05.|Regression, Linear|See analysis plan for covariates screened into model.||||||0.702
71101011|NCT04135443|141709760|SUPERIORITY||Slope|0.049||||0.375|TWO_SIDED|||||Threshold set to p\<0.05.|Regression, Linear|See analysis plan for covariates screened into model.||||||0.375
71101012|NCT04135443|141709761|SUPERIORITY||Slope|0.076||||0.313|TWO_SIDED|||||Threshold set to p\<0.05.|Regression, Linear|See analysis plan for covariates screened into model.||||||0.313
71101013|NCT04135443|141709762|SUPERIORITY||Slope|-0.01||||0.89|TWO_SIDED|||||Threshold set to p\<0.05.|Regression, Linear|See analysis plan for covariates screened into model.||||||0.890
71101014|NCT03856177|141709773|OTHER|||||||0.071|||||||t-test, 2 sided|||||||.071
71101015|NCT03460704|141709776|SUPERIORITY||LS Mean rate ratio|1.004||||0.97889|TWO_SIDED|95.0|0.747|1.349|||negative binomial model|||The number of NCFB pulmonary exacerbations was compared between treatment groups using a negative binomial model including treatment, country, and baseline use of stable concomitant therapy with oral macrolides as fixed effects and log-exposure time on treatment as an offset.||1.349|0.747|0.97889
71101016|NCT01767857|141709794|SUPERIORITY|||||||0.613|||||||Log Rank|||||||0.613
71101017|NCT01767857|141709795|SUPERIORITY|||||||0.011|||||||ANCOVA|||||||0.011
71101018|NCT01767857|141709796|SUPERIORITY|||||||0.541|||||||ANCOVA|||Statistical Analysis for Global Health Status/Qol||||0.541
71101019|NCT01767857|141709796|SUPERIORITY|||||||0.56|||||||ANCOVA|||Statistical Analysis for Pain||||0.560
71101020|NCT01767857|141709796|SUPERIORITY|||||||0.603|||||||ANCOVA|||Statistical Analysis for Fatigue||||0.603
71101021|NCT01767857|141709796|SUPERIORITY|||||||0.485|||||||ANCOVA|||Statistical Analysis for Appetite Loss||||0.485
71003151|NCT00926185|141514050|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|0.27||||0.1375|TWO_SIDED|95.0|-0.06|0.6|||Dunnett's test||Analysis of covariance model with treatment, baseline, and site.|||0.60|-0.06|0.1375
71008613|NCT02055976|141525232|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.045|STANDARD_ERROR_OF_MEAN|3.56|<|0.001|TWO_SIDED|95.0|-47.118|-32.971|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-32.971|-47.118|<0.001
71101022|NCT01767857|141709797|SUPERIORITY|||||||0.21|||||||ANCOVA|||||||0.210
71101023|NCT01767857|141709798|SUPERIORITY|||||||0.768|||||||Log Rank|||||||0.768
71101024|NCT03657407|141709832|SUPERIORITY||Mean Difference (Final Values)|-0.65||||0.17|TWO_SIDED|95.0|-0.71|2.0|||t-test, 1 sided|||Null hypothesis that Belladonna \& Opium not superior to Placebo||2.0|-0.71|0.17
71003152|NCT02069704|141514052|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%-125%.|ratio BEVZ92 to Avastin|99.4|||||TWO_SIDED|90.0|90.5|109.0|||||For the ratio: BEVZ92 represents the numerator and reference bevacizumab the denominator|Based on previously published PK data for reference bevacizumab in metastatic colorectal cancer, we assumed a conservative inter-participant coefficient of variation for AUC of around 35%. A sample size of 51 patients in each treatment arm could show bioequivalence with a nominal power of 90% and an α of 0·05, if the 90% CIs for the ratio of BEVZ92 to reference bevacizumab of the geometric means for AUC0-336h and AUCss were within the acceptance interval of 80%-125%.||109.0|90.5|
71043194|NCT01115855|141595190|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-27.69|STANDARD_ERROR_OF_MEAN|107.06|||TWO_SIDED|90.0|-238.31|182.93||||||Change from baseline at Month 42 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||182.93|-238.31|
71043195|NCT01115855|141595190|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-31.46|STANDARD_ERROR_OF_MEAN|96.48|||TWO_SIDED|95.0|-221.17|158.24||||||Change from baseline at Month 48: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||158.24|-221.17|
71043196|NCT01115855|141595190|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.04|STANDARD_ERROR_OF_MEAN|28.85|||TWO_SIDED|95.0|-58.91|54.83||||||Change from baseline at Month 13 :ANCOVA with treatment effect and covariates of the NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||54.83|-58.91|
71043197|NCT01115855|141595192|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.21|0.37||||||Change from baseline at Month 5 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.37|-0.21|
71043198|NCT01115855|141595192|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.34|0.3||||||Change from baseline at Month 9 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.30|-0.34|
71043199|NCT01115855|141595192|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-0.27|0.39||||||Change from baseline at Month 13: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.39|-0.27|
71043200|NCT01115855|141595192|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-0.41|0.45||||||Change from baseline at Month 17 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.45|-0.41|
71043201|NCT01115855|141595192|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.56|0.24||||||Change from baseline at Month 21 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.24|-0.56|
71043202|NCT01115855|141595192|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.55|0.25||||||Change from baseline at Month 25 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.25|-0.55|
71043203|NCT01115855|141595192|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.49|0.31||||||Change from baseline at Month 29 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.31|-0.49|
71043204|NCT01115855|141595192|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.57|0.44||||||Change from baseline at Month 33 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.44|-0.57|
71043205|NCT01115855|141595192|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.5|0.54||||||Change from baseline at Month 37 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.54|-0.50|
71043206|NCT01115855|141595192|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|-0.44|0.83||||||Change from baseline at Month 42 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.83|-0.44|
71043207|NCT01115855|141595192|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-0.63|0.89||||||Change from baseline at Month 48 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.89|-0.63|
71043208|NCT01115855|141595192|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.36|0.11||||||Change from baseline at Week 4 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.11|-0.36|
71043209|NCT02285634|141595214|SUPERIORITY|||||||0.42|||||||Fisher Exact|||||||0.42
71003153|NCT02069704|141514053|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%-125%.|ratio BEVZ92 to Avastin|100.0|||||TWO_SIDED|90.0|90.2|112.0||||||||112.0|90.2|
71003154|NCT01236768|141514067|EQUIVALENCE|Comparative analysis of AG200-15 and Levora for breakthrough bleeding and/or spotting.||||||0.089|||||||Chi-squared|||Comparative evaluation of AG200-15 and Levora||||0.089
71003155|NCT00605358|141514072|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4||||0.018|TWO_SIDED|95.0|1.17|4.93|||Chi-squared|||Participants in the Open Door Intervention and the Services Referral condition were compared on rates of engagement in mental health services over the study follow-up period.||4.93|1.17|.018
71003156|NCT02861118|141514073|OTHER|||||||0.024|||||||Regression, Logistic|||IBD||||0.024
71003157|NCT02861118|141514073|OTHER|||||||0.006|||||||Regression, Logistic|||Corticosteroids||||0.006
71003158|NCT02861118|141514073|OTHER|||||||0.006|||||||Regression, Logistic|||Chronic Obstructive Pulmonary Disease||||0.006
71003159|NCT02861118|141514074|OTHER|||||||0.044|||||||Regression, Logistic|||IBD||||0.044
71003160|NCT02861118|141514074|OTHER|||||||0.003|||||||Regression, Logistic|||Corticosteroids||||0.003
71003161|NCT02861118|141514074|OTHER|||||||0.003|||||||Regression, Logistic|||Myocardial Infarction||||0.003
71003162|NCT02861118|141514075|OTHER|||||||0.007|||||||Regression, Logistic|||Corticosteroids||||0.007
71003163|NCT02861118|141514076|OTHER|||||||0.002|||||||Regression, Logistic|||Corticosteroids||||0.002
71003164|NCT02861118|141514076|OTHER|||||||0.003|||||||Regression, Logistic|||Skin Disease||||0.003
71003165|NCT01690988|141514081|OTHER|Test of independence|Difference in Percentages|0.36|STANDARD_ERROR_OF_MEAN|3.301||0.912|TWO_SIDED|95.0|-6.07|7.38|||Chi-squared||Difference in delirium incidence between placebo control and combined ketamine groups.|The primary analysis was a comparison between the placebo control group and the combined ketamine groups||7.38|-6.07|0.912
71003166|NCT01690988|141514082|SUPERIORITY|||||||0.964|||||||ANOVA|one-way||We compared the combined average pain level (pain level at rest, taking a deep breath, and/or when moving) over the entire day (AM and PM).||||0.964
71003167|NCT01690988|141514083|SUPERIORITY|||||||0.476|||||||ANOVA|||"All morphine equivalent drugs consumed by patients perioperatively~Opioid Drugs included:~\* Postoperatively while still in hospital, the list of pain medication used included Morphine, Hydromorphone, Meperidine, Nalbuphine, Oxycodone,Oxymorphone, Tramadol, bupivacaine, (Codeine, Fentanyl, Naloxone) Total Opiates (Morphine Equivalent) in milligrams The median(IQR) opioid consumption was compared across the three study groups Placebo vs. Lo-K (0.5 mg/kg) vs. Hi-K (1 mg/kg)"||||0.476
71043210|NCT02285634|141595214|SUPERIORITY|||||||0.52|||||||Fisher Exact|||||||0.52
71043211|NCT02285634|141595214|SUPERIORITY|||||||0.93|||||||Fisher Exact|||||||0.93
71043212|NCT02285634|141595215|SUPERIORITY|||||||0.06|||||||Fisher Exact|||||||0.06
71043213|NCT02285634|141595215|SUPERIORITY|||||||0.61|||||||Fisher Exact|||||||0.61
71043214|NCT02285634|141595215|SUPERIORITY|||||||0.78|||||||Fisher Exact|||||||0.78
71043215|NCT02285634|141595216|SUPERIORITY|||||||0.27|||||||Fisher Exact|||||||0.27
71043216|NCT02285634|141595216|SUPERIORITY|||||||0.17|||||||Fisher Exact|||||||0.17
71043217|NCT02285634|141595216|SUPERIORITY|||||||0.56|||||||Fisher Exact|||||||0.56
71043218|NCT02285634|141595217|SUPERIORITY|||||||0.78|||||||Fisher Exact|||||||0.78
71043219|NCT02285634|141595217|SUPERIORITY|||||||0.1|||||||Fisher Exact|||||||0.10
71043220|NCT02285634|141595217|SUPERIORITY|||||||0.47|||||||Fisher Exact|||||||0.47
71043221|NCT03173170|141595218|OTHER||Mean ratio|1.0622|||||TWO_SIDED|90.0|0.9569|1.1792||||||A paired t-test on the natural log-transformed parameters was performed. The means and difference of means for the log-transformed parameters were exponentiated to obtain the point estimates of the itraconazole effect and 90 percent (%) confidence intervals (CIs).||1.1792|0.9569|
71043222|NCT03173170|141595219|OTHER||Mean ratio|1.4892|||||TWO_SIDED|90.0|1.3851|1.6012||||||A paired t-test on the natural log-transformed parameters was performed. The means and difference of means for the log-transformed parameters were exponentiated to obtain the point estimates of the itraconazole effect and 90% CIs.||1.6012|1.3851|
71043223|NCT03420768|141595244|SUPERIORITY||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|0.13|17.7||||||||17.70|0.13|
71043224|NCT03420768|141595244|SUPERIORITY||Odds Ratio (OR)|1.77|||||TWO_SIDED|95.0|0.26|20.23||||||||20.23|0.26|
71043225|NCT00983476|141595251|SUPERIORITY_OR_OTHER||Slope|2.2||||0.11|TWO_SIDED||||||Mixed Models Analysis||Reference group is Web-based MOVE SMI: In-person MOVE SMI visit x group Beta estimate is .27 (p=.08); Reference group is Web-based MOVE SMI: Usual care plus handouts visit x group Beta estimate is .29 (p=.06).|Difference in Body Mass Index (BMI) by study arm at 6 months after controlling for BMI 6 months prior to baseline using a repeated measures mixed model with arm, time, and the interaction of arm by time||||0.11
71043226|NCT00983476|141595252|SUPERIORITY_OR_OTHER||Slope|4.02||||0.02|TWO_SIDED||||||Mixed Models Analysis||Reference group is Web-based MOVE SMI: In-person MOVE SMI visit x group Beta estimate is .40 (p=.02); Reference group is Web-based MOVE SMI: Usual care plus handouts visit x group Beta estimate is .44 (p=.01).|In the obese sample, difference in Body Mass Index (BMI) by study arm at 6 months after controlling for BMI 6 months prior to baseline using a repeated measures mixed model with arm, time, and the interaction of arm by time||||0.02
71043227|NCT00983476|141595253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.14||||0.32|TWO_SIDED||||||ANOVA||No comparison between groups was conducted because overall model test was not statistically significant.|||||0.32
71043228|NCT00983476|141595254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.23||||0.11|TWO_SIDED||||||ANOVA||No comparison between groups was conducted because overall model test was NS.|||||0.11
71003168|NCT01690988|141514084|SUPERIORITY||frequency-test|0.572||||0.572|TWO_SIDED||||||Chi-squared|||"Assessed from patient-reported postoperative nausea and vomiting section of Behavioral Pain Scale or Behavioral Pain Scale (Non-Intubated) Patients where asked whether they currently have nausea/vomiting AM \& PM the response choices: None, Mild, Moderate, Severe Incidence of nausea\\vomiting accounted for any positive reporting(Mild, moderate, or sever) Daily incidence accounted for any positive incidence AM/PM in each POD Any POD nausea/vomiting reports the incidence across day 1-3"||||0.572
71003169|NCT01690988|141514086|SUPERIORITY|||||||0.01|||||||Chi-squared|||Frequency of patients reporting hallucinations using the DSAQ instrument.||||0.01
71003170|NCT01690988|141514087|SUPERIORITY|||||||0.03||||||"Patients where asked whether Following their surgery they had bad dreams or nightmares the response choices: Yes/No question The incidence of hallucination and nightmares were assessed separately and compared across the three study group."|Chi-squared|||||||0.03
71003171|NCT00638274|141514088|OTHER||||||>|0.05|||||||Chi-squared|||||||>.05
71003172|NCT00638274|141514088|OTHER||||||>|0.05|||||||Chi-squared|||||||>.05
71003173|NCT01634100|141514090|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa and rifampicin divided by empa|Geometric Mean Ratio|135.2|STANDARD_DEVIATION|7.3|||TWO_SIDED|90.0|129.58|141.06|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the intra-subject coefficient of variation.|||141.06|129.58|
71003174|NCT01634100|141514090|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus probenecid divided by empa|Geometric Mean Ratio|153.47|STANDARD_DEVIATION|7.4|||TWO_SIDED|90.0|146.41|160.88|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the intra-subject coefficient of variation.|||160.88|146.41|
71003175|NCT01634100|141514091|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa and rifampicin divided by empa|Geometric Mean Ratio|175.14|STANDARD_DEVIATION|15.4|||TWO_SIDED|90.0|160.14|191.56|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the intra-subject coefficient of variation.|||191.56|160.14|
71003176|NCT01634100|141514091|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus probenecid divided by empa|Geometric Mean Ratio|125.6|STANDARD_DEVIATION|15.9|||TWO_SIDED|90.0|113.67|138.78|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the intra-subject coefficient of variation.|||138.78|113.67|
71003177|NCT01634100|141514092|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa and rifampicin divided by empa|Geometric Mean Ratio|136.42|STANDARD_DEVIATION|7.5|||TWO_SIDED|90.0|130.61|142.48|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the intra-subject coefficient of variation.|||142.48|130.61|
71043229|NCT00983476|141595255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75||||0.47|TWO_SIDED||||||ANOVA||No comparison between groups was conducted because overall model test was NS.|||||0.47
71043230|NCT00983476|141595256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.67||||0.51|TWO_SIDED||||||ANOVA||No comparison between groups was conducted because overall model test was NS.|||||0.51
71043231|NCT00983476|141595257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.83|TWO_SIDED||||||ANOVA||No comparison between groups was conducted because overall model test was NS.|||||0.83
71003178|NCT01634100|141514092|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus probenecid divided by empa|Geometric Mean Ratio|153.61|STANDARD_DEVIATION|7.5|||TWO_SIDED|90.0|146.5|161.06|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the intra-subject coefficient of variation.|||161.06|146.50|
71003179|NCT02809846|141514108|OTHER|Bivariate associations between variables were assessed using statistical methods appropriate for the variable types. Baseline characteristics (demographics, other morbidities, baseline medication use, pain intensity and QOL) were compared between the two treatment groups to assess effectiveness of randomization and identify important covariates for multivariable analyses. Associations between demographic variables and primary and secondary endpoints were examined.|||||<|0.05||||||Sensitivity analyses comparing use of data from all participants with use of participants with complete data only was also performed. Agreement between different measures representing the same variable type was assessed using correlation analyses.|Mixed Models Analysis|Multivariable analysis with mixed effect regression models were used to assess the effect of treatment group on the primary and secondary outcomes.||Initially, a sample size of 20 participants per treatment group (active and sham) was selected to achieve 90% power to find a 20% difference in mean percent change in opioid consumption between the two groups with an estimated standard deviation of 22% and 80% power to detect the same difference with a standard deviation of 19% at a two-sided alpha = 0.05|Similar models were used to assess associations of treatment group with secondary endpoints. Model fit was assessed by Akaike's Information Criteria to determine optimal covariance structure.|||<0.05
71008614|NCT02055976|141525232|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-53.81|STANDARD_ERROR_OF_MEAN|3.56|<|0.001|TWO_SIDED|95.0|-60.883|-46.737|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-46.737|-60.883|<0.001
71008615|NCT02055976|141525232|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-58.62|STANDARD_ERROR_OF_MEAN|3.533|<|0.001|TWO_SIDED|95.0|-65.64|-51.6|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-51.600|-65.640|<0.001
71008616|NCT02055976|141525234|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.896|STANDARD_ERROR_OF_MEAN|2.643|<|0.001|TWO_SIDED|95.0|3.646|14.145|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||14.145|3.646|<0.001
70924635|NCT04321031|141342038|SUPERIORITY||Risk Difference (RD)|0.27|||||TWO_SIDED|90.0|0.07|0.43||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.43|0.07|
71003180|NCT01512693|141514109|NON_INFERIORITY_OR_EQUIVALENCE|Similarity will be concluded if the GMR (moderate hepatic insufficiency / healthy) is contained within the interval \[0.40, 2.50\].|GMR|0.85|||||TWO_SIDED|90.0|0.61|1.19||||||Natural log-transformed plasma values were analyzed using an analysis of covariance (ANCOVA) model with a categorical factor for population (moderate hepatic insufficiency participants, healthy matched control participants) and continuous covariates for age and body mass index (BMI). Data are back transformed to geometric least-squares mean ratio (GMR) (moderate hepatic insufficiency / healthy) and 90% confidence intervals.||1.19|0.61|
71003181|NCT01512693|141514110|SUPERIORITY_OR_OTHER||GMR|0.71|||||TWO_SIDED|90.0|0.51|1.0||||||Natural log-transformed plasma values were analyzed using an ANCOVA model with a categorical factor for population (moderate hepatic insufficiency participants, healthy matched control participants) and continuous covariates for age and BMI. Data are back transformed to GMR (moderate hepatic insufficiency / healthy) and 90% confidence intervals.||1.00|0.51|
71003182|NCT01975376|141514113|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.930905|TWO_SIDED|95.0|0.8|1.22|||Log Rank|||Hazard ratio and 95 percent (%) Confidence Interval (CI) were from a Cox proportional hazards model stratified by geographic region and low density lipoprotein cholesterol (LDL-C) at pre-screening (less than \[\<\] 100 milligrams per deciliters \[mg/dL\], greater than and equal to \[\>=\] 100 mg/dL) with treatment as a co-variate.||1.22|0.80|0.930905
71003183|NCT01975376|141514114|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.784265|TWO_SIDED|95.0|0.82|1.3|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.30|0.82|0.784265
71003184|NCT01975376|141514115|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.892441|TWO_SIDED|95.0|0.81|1.2|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.20|0.81|0.892441
71003185|NCT01975376|141514116|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.845797|TWO_SIDED|95.0|0.83|1.26|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.26|0.83|0.845797
71003186|NCT01975376|141514117|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.431903|TWO_SIDED|95.0|0.49|1.36|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.36|0.49|0.431903
71003187|NCT01975376|141514118|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.883797|TWO_SIDED|95.0|0.8|1.21|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.21|0.80|0.883797
71101025|NCT03657407|141709833|SUPERIORITY||Mean Difference (Final Values)|-2.02||||0.29|TWO_SIDED|95.0|-5.4|9.5|||t-test, 1 sided|||Null hypothesis that Belladonna \& Opium not superior to Placebo||9.5|-5.4|0.29
71101026|NCT03657407|141709834|SUPERIORITY||Median Difference (Final Values)|-19.31||||0.05|TWO_SIDED|95.0|-43.1|4.5|||t-test, 1 sided|||Null hypothesis that Belladonna \& Opium not superior to Placebo||4.5|-43.1|0.05
71003188|NCT01975376|141514119|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.45569|TWO_SIDED|95.0|0.74|1.95|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.95|0.74|0.455690
71003189|NCT01975376|141514120|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.469496|TWO_SIDED|95.0|0.84|1.48|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.48|0.84|0.469496
71003190|NCT01975376|141514121|SUPERIORITY||Hazard Ratio (HR)|1.54||||0.633022|TWO_SIDED|95.0|0.26|9.23|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||9.23|0.26|0.633022
71003191|NCT01975376|141514122|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.46765|TWO_SIDED|95.0|0.83|1.48|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.48|0.83|0.467650
71101027|NCT03657407|141709835|SUPERIORITY||Mean Difference (Final Values)|0.85||||0.42|TWO_SIDED|95.0|0.42|1.7|||t-test, 1 sided|||Null hypothesis that Belladonna \& Opium not superior to Placebo||1.7|0.42|0.42
71101028|NCT02628145|141709836|OTHER||Mean Difference (Final Values)|-0.01||||0.91|TWO_SIDED||||||Mixed Models Analysis|||||||0.91
71101029|NCT02628145|141709837|SUPERIORITY|||||||0.88|||||||Chi-squared|||||||0.88
71101030|NCT02628145|141709838|SUPERIORITY|||||||0.068|||||||Fisher Exact|||||||0.068
71003192|NCT01975376|141514123|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.015462|TWO_SIDED|95.0|0.32|0.89|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||0.89|0.32|0.015462
71003193|NCT01975376|141514124|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.011863|TWO_SIDED|95.0|0.33|0.88|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||0.88|0.33|0.011863
71003194|NCT01975376|141514125|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.316066|TWO_SIDED|95.0|0.12|2.0|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||2.00|0.12|0.316066
71003195|NCT01975376|141514126|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.020328|TWO_SIDED|95.0|0.3|0.91|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||0.91|0.30|0.020328
71003196|NCT01975376|141514127|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.367069|TWO_SIDED|95.0|0.53|1.27|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.27|0.53|0.367069
71003197|NCT01975376|141514128|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.443081|TWO_SIDED|95.0|0.56|1.29|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.29|0.56|0.443081
71003198|NCT01975376|141514129|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.343817|TWO_SIDED|95.0|0.71|1.12|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.12|0.71|0.343817
71003199|NCT01975376|141514130|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.889065|TWO_SIDED|95.0|0.59|1.85|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.85|0.59|0.889065
71003200|NCT01975376|141514131|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.308388|TWO_SIDED|95.0|0.69|1.13|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.13|0.69|0.308388
71003201|NCT01975376|141514132|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.874835|TWO_SIDED|95.0|0.74|1.42|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.42|0.74|0.874835
71003202|NCT01975376|141514133|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.526269|TWO_SIDED|95.0|0.79|1.6|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.60|0.79|0.526269
71003203|NCT01975376|141514134|SUPERIORITY||LS-mean difference|-60.57|||<|0.001|TWO_SIDED|95.0|-61.43|-59.71|||Mixed Effect Model Repeat Measurement|||Lease Square (LS)- mean differences, associated 95% CI, and p-values were from a mixed model repeated measures (MMRM) model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-59.71|-61.43|<0.001
71003204|NCT01975376|141514135|SUPERIORITY||LS-mean difference|-54.7|||<|0.001|TWO_SIDED|95.0|-55.48|-53.92|||Mixed Effect Model Repeat Measurement|||LS- mean differences and associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-53.92|-55.48|<0.001
71003205|NCT01975376|141514136|SUPERIORITY||LS-mean difference|-46.72|||<|0.001|TWO_SIDED|95.0|-47.68|-45.76|||ANCOVA|||LS- mean difference and associated 95% CI, and p-value were from an analysis of covariance (ANCOVA) model with fixed effects for treatment group, baseline value, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-45.76|-47.68|<0.001
71003206|NCT01975376|141514137|SUPERIORITY||LS-mean difference|-54.88|||<|0.001|TWO_SIDED|95.0|-55.66|-54.09|||Mixed Effect Model Repeat Measurement|||Non-HDL-C: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-54.09|-55.66|<0.001
71003207|NCT01975376|141514137|SUPERIORITY||LS-mean difference|-36.51|||<|0.001|TWO_SIDED|95.0|-37.07|-35.95|||Mixed Effect Model Repeat Measurement|||Total cholesterol: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-35.95|-37.07|<0.001
71003208|NCT01975376|141514137|SUPERIORITY||LS-mean difference|-20.17|||<|0.001|TWO_SIDED|95.0|-21.42|-18.93|||Mixed Effect Model Repeat Measurement|||VLDL-C: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-18.93|-21.42|<0.001
71101031|NCT02628145|141709839|SUPERIORITY|||||||0.48|||||||Mixed Models Analysis|||||||0.48
71101032|NCT02628145|141709840|SUPERIORITY|||||||0.52|||||||Mixed Models Analysis|||||||0.52
71101033|NCT02628145|141709841|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71101034|NCT02628145|141709842|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71101035|NCT02628145|141709843|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71101036|NCT02628145|141709844|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71101037|NCT02628145|141709846|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||0.04
71003209|NCT01975376|141514137|SUPERIORITY||LS-Mean Difference|-30.25|||<|0.001|TWO_SIDED|95.0|-32.44|-28.07|||Mixed Effect Model Repeat Measurement|||RLP-C: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-28.07|-32.44|<0.001
71043232|NCT01175473|141595263|SUPERIORITY_OR_OTHER||Least squares (LS) Mean Difference|-154.42|||<|0.0001|TWO_SIDED|95.0|-180.3|-128.54||Linear fixed effects model with fixed terms for treatment, study site and GLU-AUC(0:30-4:30h) at baseline as covariate was used (using Statistical Analysis System \[SAS®\] PROC MIXED procedure).|Linear fixed effects model|No alpha adjustment was performed.||To detect a difference of 100 or 150 h\*mg/dL in change from baseline to Day 28 in GLU-AUC(0:30-4:30h) between lixisenatide and liraglutide, 60 patients per group would provide a power of 90% assuming common standard deviation of 170 or 250 h\*mg/dL, respectively, with a 2-sided test at 5% significance level.||-128.54|-180.30|<0.0001
71043233|NCT04458467|141595317|SUPERIORITY|||||||0.033|||||||t-test, 2 sided|||||||0.033
71043234|NCT04458467|141595318|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71043235|NCT00810888|141595516|SUPERIORITY|||||||1||||||not adjusted for multiple comparisons as a prior hypothesis critical value \<0.05|Fisher Exact|||Fisher's exact test||||1.00
71003210|NCT01975376|141514137|SUPERIORITY||LS-Mean Difference|-58.55|||<|0.001|TWO_SIDED|95.0|-59.42|-57.69|||Mixed Effect Model Repeat Measurement|||Apo B: LS -mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 52 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-57.69|-59.42|<0.001
71003211|NCT01975376|141514137|SUPERIORITY||LS-Mean Difference|6.14|||<|0.001|TWO_SIDED|95.0|5.69|6.59|||Mixed Effect Model Repeat Measurement|||HDL-C: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||6.59|5.69|<0.001
71003212|NCT01975376|141514137|SUPERIORITY||LS-Mean Difference|3.53|||<|0.001|TWO_SIDED|95.0|3.02|4.03|||Mixed Effect Model Repeat Measurement|||Apo A-I: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 52 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||4.03|3.02|<0.001
71003213|NCT01975376|141514138|SUPERIORITY||LS-mean difference|0.67|||<|0.001|TWO_SIDED|95.0|0.66|0.68|||Mixed Effect Model Repeat Measurement|||Lp (a): LS- mean differences and associated 95% CI, and p-values were from an MMRM model on the difference of log-transformed observations through Week 52 with fixed effects for treatment group, visit, treatment group\*visit interaction, log-transformed baseline value, log-transformed baseline value\*visit interaction, geographical region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||0.68|0.66|<0.001
71003214|NCT01975376|141514138|SUPERIORITY||LS-mean difference|0.81|||<|0.001|TWO_SIDED|95.0|0.8|0.81|||Mixed Effect Model Repeat Measurement|||Triglycerides: LS- mean differences and associated 95% CI, and p-values were from an MMRM model through Week 70 on the difference of log-transformed observations with fixed effects for treatment group, visit, treatment group\*visit interaction, log-transformed baseline value, log-transformed baseline value\*visit interaction, geographical region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||0.81|0.80|<0.001
71003215|NCT01975376|141514139|SUPERIORITY||LS-mean difference|1.06|||<|0.001|TWO_SIDED|95.0|1.03|1.1|||Mixed Effect Model Repeat Measurement|||LS- mean differences and associated 95% CI, and p-values were from an MMRM model on the difference of log-transformed observations through Week 52 with fixed effects for treatment group, visit, treatment group\*visit interaction, log-transformed baseline value, log-transformed baseline value\*visit interaction, geographical region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||1.10|1.03|<0.001
71043236|NCT00810888|141595517|SUPERIORITY|||||||0.66|||||||Fisher Exact|||Only the randomized subjects will be compared||||0.66
71101038|NCT00420056|141709849|SUPERIORITY_OR_OTHER|||||||0.4854|TWO_SIDED||||||Regression, Linear|||||||0.4854
71003216|NCT03054740|141514178|SUPERIORITY||||||||||||||||||Levene's Test of Equality of Error Variances (Design: Intercept + Pain Previous IV + Intervention) F = .001, df1 = 1, df2=28, Sig. = .972|||
71003217|NCT03054740|141514179|SUPERIORITY|||||||0.39|||||||Fisher Exact|||||||.390
71043237|NCT00810888|141595518|SUPERIORITY||Sensitivity|38.5||||0.004|TWO_SIDED|95.0|17.6|64.6|||Fisher Exact|||||64.6|17.6|0.004
71043238|NCT00810888|141595519|SUPERIORITY||Specificity|94.2||||0.004|TWO_SIDED|95.0|85.6|98.1|||Fisher Exact|||||98.1|85.6|0.004
71043239|NCT00810888|141595520|SUPERIORITY|||||||0.47|||||||Fisher Exact|||||||0.47
71043240|NCT00810888|141595521|SUPERIORITY|||||||0.58|||||||Fisher Exact|||||||0.58
71043241|NCT00810888|141595522|OTHER|A Kappa test of overall agreement was used|Kappa|0.77|||||TWO_SIDED|95.0|0.61|0.93|||||A kappa of \>0.75 is considered excellent agreement|||0.93|0.61|
71043242|NCT00810888|141595523|SUPERIORITY|||||||0.25|||||||Kruskal-Wallis|||Groups 1 and 2 only the spot positive subjects randomized to interventional drug or placebo||||0.25
71043243|NCT01684878|141595525|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.88||||0.4983|TWO_SIDED|95.0|0.62|1.27|||2 sided log-rank|||The stratified time-to-event analysis included the treatment group variable plus the following stratification factors: selected chemotherapy cohort (gemcitabine versus topotecan vs paclitaxel), previous anti-angiogenic therapy (yes versus no), and progression-free interval (PFI) since platinum therapy (\< 3 months versus 3-6 months). A hazard ratio \< 1 favored the pertuzumab + chemotherapy treatment arm.||1.27|0.62|0.4983
71101039|NCT00420056|141709850|SUPERIORITY_OR_OTHER|||||||0.709|TWO_SIDED||||||Regression, Linear|||||||0.7090
71101040|NCT00420056|141709853|SUPERIORITY_OR_OTHER||Kappa|0.0638|||||TWO_SIDED|95.0|-0.0449|0.1726||||||FLT-PET response versus Objective response||0.1726|-0.0449|
71101041|NCT00420056|141709853|SUPERIORITY_OR_OTHER||Kappa|0.1864|||||TWO_SIDED|95.0|-0.2316|0.6045||||||FDG-PET response versus Objective response||0.6045|-0.2316|
71101042|NCT00420056|141709867|SUPERIORITY_OR_OTHER|||||||0.5954|TWO_SIDED||||||Regression, Linear|||Concentration versus Ki-67||||0.5954
71101043|NCT00420056|141709867|SUPERIORITY_OR_OTHER|||||||0.1286|TWO_SIDED||||||Regression, Linear|||Concentration versus Cyclin D1||||0.1286
71101044|NCT00420056|141709867|SUPERIORITY_OR_OTHER|||||||0.0956|TWO_SIDED||||||Regression, Linear|||Concentration versus phospho-Rb||||0.0956
71101045|NCT00420056|141709867|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Regression, Linear|||Concentration versus FLT-PET SUVmax||||0.2800
71101046|NCT00420056|141709867|SUPERIORITY_OR_OTHER|||||||0.4921|TWO_SIDED||||||Regression, Linear|||Concentration versus FDG-PET SUVmax||||0.4921
71101047|NCT00907088|141709876|SUPERIORITY_OR_OTHER|||||||0.42|||||||Chi-squared|||||||0.42
71101048|NCT02301793|141709879|OTHER||Odds Ratio (OR)|1.0||||0.05|TWO_SIDED|95.0||||The reported p-values were calculated by reiterating the multiple outputation procedure 1000 times, we estimated the odds ratios (ORs) and their 95% confidence intervals conditional on the floor and nurse.|Regression, Logistic|||The hypothesis comparing the different educational arms was evaluated using an intention-to-treat approach (i.e. all nurses were included regardless of training completion) accounting for clustering in the data and comparing rates of VTE prophylaxis dose non-administration at baseline and during the Post-Education period. Two per-protocol sensitivity analyses were performed. They compared the Baseline vs. Post-Education periods for nurses who received training and nurses who completed training.||||0.05
71101049|NCT02301793|141709883|OTHER||Odds Ratio (OR)|1.0||||0.05|TWO_SIDED|95.0||||The reported p-values were calculated by reiterating the multiple outputation procedure 1000 times, we estimated the odds ratios (ORs) and their 95% confidence intervals conditional on the floor and nurse.|Regression, Logistic|||The hypothesis comparing the different educational arms was evaluated using an intention-to-treat approach (i.e. all nurses were included regardless of training completion) accounting for clustering in the data and comparing rates of VTE prophylaxis dose non-administration at baseline and during the Post-Education period. Two per-protocol sensitivity analyses were performed. They compared the Baseline vs. Post-Education periods for nurses who received training and nurses who completed training.||||0.05
71043244|NCT01684878|141595527|SUPERIORITY_OR_OTHER||Difference in response rate|6.06||||0.4102|TWO_SIDED|95.0|6.0|18.3|||Fisher Exact||Approximate 95% CI for difference of 2 rates using Hauck-Anderson method.|||18.3|6.0|0.4102
71043245|NCT01684878|141595532|SUPERIORITY_OR_OTHER||Hazard ratio (stratified)|0.9||||0.596|TWO_SIDED|95.0|0.61|1.32|||2 sided log-rank||A hazard ratio \< 1 favored the Pertuzumab + Chemotherapy treatment group|The stratified time-to-event analysis included the treatment group variable plus the following stratification factors: selected chemotherapy cohort (gemcitabine versus topotecan versus paclitaxel), previous angiogenic therapy (yes versus no) and PFI since platinum therapy (\<3 months versus 3-6 months).||1.32|0.61|0.5960
71043246|NCT00479388|141595635|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.5|STANDARD_ERROR_OF_MEAN|1.6||0.006||95.0|-7.7|-1.3|||Repeated measures analysis|Study times: 4, 8 and 12 weeks. Terms: treatment-by-time, gender-by-time, baseline LDL-C-by-time and concomitant statin group-by-time interaction.||||-1.3|-7.7|0.006
71043247|NCT00479388|141595636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.6|STANDARD_ERROR_OF_MEAN|1.2|<=|0.001||95.0|13.4|17.9|||Repeated measures analysis|Study times: 4, 8 and 12 weeks. Terms: treatment-by-time, gender-by-time, baseline HDL-C-by-time and concomitant statin group-by-time interaction.||||17.9|13.4|<=0.001
71043248|NCT00479388|141595637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.4|||<=|0.001||95.0|-19.2|-11.7|||Repeated measures analysis|ANCOVA model based on Tukey's normalized ranks with term for treatment, gender, concomitant statin group and Tukey's normal score of baseline.||||-11.7|-19.2|<=0.001
71101050|NCT04105725|141709886|SUPERIORITY||||||<|0.05|||||||negative binomial regression|||||||<0.05
71101051|NCT00480025|141709893|SUPERIORITY|RMF included: 1) Number of chemotherapy cycles received (1, 2 vs. 3, 4), if any; 2) Pathological stage of the disease (IB vs. II vs. IIIA); 3) Type of lymph-node sampling (minimal lymph-node sampling vs. systematic radical mediastinal lymphadenectomy); 4) ECOG performance status randomization (0, 1 vs. 2); 5) Smoking status ( 100 cigarettes a lifetime vs. \> 100 cigarettes and current smoker vs. \>100 cigarettes and past smoker).|Treatment Efficacy|1.024||||0.7379|TWO_SIDED|95.0|0.891|1.177||2-sided p-value of Likelihood Ratio test from RMF-adjusted Cox regression, Efron method used to handle ties.|Regression, Cox|Overall population objective reached if p-value \< 2.56%/4% in absence/presence of statistically significant effect in the No-CT population.||Analysis compared DFS PYAR between groups for period from 1st treatment dose to DLP. A Cox model was used to evaluate treatment efficacy (TE). TE was calculated as PYAR in GSK1572932 Group (PYAR1) divided by PYAR in Placebo Group (PYAR2), and weighed for adjustment factors. This comparison in all patients (overall population) also included taking into account stratification by previous CT vs. No-CT treatment and weighing using randomization-minimization factors (RMF) as regressors.||1.177|0.891|0.7379
71043249|NCT01876368|141595641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.19|STANDARD_ERROR_OF_MEAN|0.78|<|0.001|TWO_SIDED|95.0|-4.73|-1.65|||ANCOVA|||||-1.65|-4.73|<0.001
71043250|NCT01955044|141595653|SUPERIORITY||Median Difference (Final Values)|1.23||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||DHA levels||||0.05
71043251|NCT02260258|141595656|EQUIVALENCE|Time variable log transformed and compared using linear regression controlling for shock stratification and site. Effect estimate represents geometric mean difference. Values above 1.0 favor longer duration in the NMB arm.|Geometric mean difference|1.0||||0.82|TWO_SIDED|95.0|0.7|1.4||A priori threshold for significance 0.05|Regression, Linear|||||1.4|0.7|0.82
71043252|NCT02260258|141595657|EQUIVALENCE|LOS truncated at 28 days and compared using negative binomial regression controlling for stratification and site. Effect estimates represent incidence rate ratios. The parameter estimate, p value and CI provided below are from the negative binomial regression carried out all patients (N = 37 in NMB and 43 in Usual Care)|Incidence rate ratio|1.4||||0.09|TWO_SIDED|95.0|1.0|1.9|||Negative binomial regression|||All patients analyzed (N = 37 in NMB and 43 in Usual Care)||1.9|1.0|0.09
71043253|NCT02260258|141595657|EQUIVALENCE|LOS truncated at 28 days and compared using negative binomial regression controlling for stratification and site. Effect estimates represent incidence rate ratios. The parameter estimate, p value and CI provided below are from the negative binomial regression carried out on ICU survivors alone (n = 14 in NMB and 14 in Control)|Incidence rate ratio|1.3||||0.35|TWO_SIDED|95.0|0.8|2.0|||Negative binomial regression|||ICU survivors alone analyzed (n = 14 in each arm)||2.0|0.8|0.35
71003218|NCT03489850|141514183|SUPERIORITY||Parameter Estimate|0.34|STANDARD_ERROR_OF_MEAN|0.69||0.62|TWO_SIDED|95.0|-1.01|1.69|||Generalized Estimating Equation|||||1.69|-1.01|.62
71003219|NCT03489850|141514184|SUPERIORITY||Odds Ratio (OR)|0.55|||<|0.05|TWO_SIDED|95.0|0.3|0.98|||Generalized Estimating Equation|||||.98|.30|<0.05
71101052|NCT00480025|141709894|SUPERIORITY|RMF taken into account included: 1) Number of chemotherapy cycles received (1, 2 vs. 3, 4), if any; 2) Pathological stage of the disease (IB vs. II vs. IIIA); 3) Type of lymph-node sampling (minimal lymph-node sampling vs. systematic radical mediastinal lymphadenectomy); 4) ECOG performance status randomization (0, 1 vs. 2); 5) Smoking status ( 100 cigarettes a lifetime vs. \> 100 cigarettes and current smoker vs. \> 100 cigarettes and past smoker).|Treatment Efficacy|0.97||||0.7572|TWO_SIDED|95.0|0.797|1.179||2-sided p-value of Likelihood Ratio test from RMF-adjusted Cox regression, Efron method used to handle ties.|Regression, Cox|No-CT population objective reached if p-value \< 2.56%/4% in absence/presence of statistically significant effect in the No-CT population.||Analysis compared DFS PYAR between groups for the period from 1st treatment dose to DLP. A Cox model was used to evaluate treatment efficacy (TE). TE was calculated as PYAR in GSK1572932 No-CT Group (PYAR1) divided by PYAR in Placebo No-CT Group (PYAR2) and weighed for adjustment factors. This comparison in all patients (overall population) also included taking into account weighing using randomization-minimization factors (RMF) as regressors.||1.179|0.797|0.7572
71101053|NCT03726879|141709930|SUPERIORITY||Odds Ratio (OR)|0.67||||0.1846|TWO_SIDED|95.0|0.37|1.21||The threshold for statistical significance was a p-value =0.048|Cochran-Mantel-Haenszel|||||1.21|0.37|0.1846
71101054|NCT03726879|141709931|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9551|TWO_SIDED|95.0|0.67|1.46||The threshold for statistical significance was a p-value =0.002|Cochran-Mantel-Haenszel|||||1.46|0.67|0.9551
71101055|NCT03726879|141709934|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.5|1.59|||Log Rank|||All Participants||1.59|0.50|
71101056|NCT03726879|141709934|SUPERIORITY||Hazard Ratio (HR)|1.67|||||TWO_SIDED|95.0|0.65|4.32|||Log Rank|||PD-L1 IC1/2/3||4.32|0.65|
71003220|NCT03489850|141514185|SUPERIORITY||Odds Ratio (OR)|0.83|||<|0.05|TWO_SIDED|95.0|0.47|1.48|||Generalized Estimating Equation|||||1.48|0.47|<0.05
71003221|NCT03489850|141514186|SUPERIORITY||F|7.36|||<|0.05|TWO_SIDED||||||ANCOVA|||||||<0.05
71003222|NCT02092324|141514265|SUPERIORITY|1-proportion test for greater than 10% difference.||||||0.002||||||p-value for Protocol-defined objective response|binomial|||Proportion estimated using Clopper-Pearson method. P-value is one-sided proportion test for greater than 10% response rate (based on Simon's 2-stage).||||0.002
71043254|NCT02260258|141595658|EQUIVALENCE|Duration log transformed and compared using linear regression controlling for shock stratification and site. Includes all patients (n=37 in NMB and n = 43 in control). Effect estimates represent geometric mean difference. Values above 1.0 favor longer duration in the NMB arm.|Geometric mean difference|1.3||||0.18|TWO_SIDED|95.0|0.9|1.9|||Regression, Linear|Duration log transformed and so parameter estimate represents geometric mean difference.||Anaysis for the full data (n= 37 in NMB and 43 in Control)||1.9|0.9|0.18
71043255|NCT02260258|141595658|EQUIVALENCE|Duration log transformed and compared using linear regression controlling for shock stratification and site. Includes patients surviving to discontinuation of mechanical ventilation (n=14 in each group). Two patients discharged from the hospital on mechanical ventilation have duration truncated at time of discharge and are considered survivors to extubation. Effect estimates represent geometric mean difference. Values above 1.0 favor longer duration in the NMB arm.|Geometric mean difference|1.4||||0.32|TWO_SIDED|95.0|0.7|2.9|||Regression, Linear|Duration log transformed and so parameter estimate represents geometric mean difference.||Anaysis for the patients surviving to extubation (n= 14 in both groups)||2.9|0.7|0.32
71043256|NCT02260258|141595659|EQUIVALENCE|Comparison made using logistic regression controlling for shock stratification and site. Effect estimates represent odds ratios|Odds Ratio (OR)|1.3||||0.63|TWO_SIDED|95.0|0.5|3.3|||Regression, Logistic|||||3.3|0.5|0.63
71043257|NCT02260258|141595660|EQUIVALENCE|Comparison made using logistic regression controlling for shock stratification and site. Effect estimates represent odds ratios|Odds Ratio (OR)|1.7||||0.35|TWO_SIDED|95.0|0.6|4.7|||Regression, Logistic|||||4.7|0.6|0.35
71043258|NCT01610063|141595666|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Comparison for QIDS-C16||||<0.0001
71043259|NCT01610063|141595667|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Comparison between groups for HAMD-17||||<0.0001
71101057|NCT03726879|141709934|SUPERIORITY||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.27|1.22|||Log Rank|||PD-L1 IC0 Participants||1.22|0.27|
71101058|NCT03726879|141709934|SUPERIORITY||Hazard Ratio (HR)|1.28|||||TWO_SIDED|95.0|0.58|2.82|||Log Rank|||ER/PgR Negative Participants||2.82|0.58|
71003223|NCT02092324|141514265|SUPERIORITY|1-proportion test for greater than 10% difference||||||0.9||||||p-value is for IWG-defined objective response|binomial|||Proportion estimated using Clopper-Pearson method. P-value is one-sided proportion test for greater than 10% response rate (based on Simon's 2-stage).||||0.90
71003224|NCT02092324|141514268|SUPERIORITY|Proportion estimated using Clopper-Pearson method. P-value is one-sided proportion test for greater than 10% response rate.|||||<|0.0001||||||p-value for protocol-defined objective response. p-value for IWG-defined objective response is 0.70|Clopper-Pearson method|||||||<0.0001
71003225|NCT02092324|141514268|SUPERIORITY|Proportion estimated using Clopper-Pearson method. P-value is one-sided proportion test for greater than 10% response rate.||||||0.7||||||p-value for IWG-defined objective response|Clopper-Pearson method|||||||0.70
71003226|NCT02092324|141514278|EQUIVALENCE|2-sample test for equality of proportions with continuity correction (Pearson's chi-square test statistic)||||||0.003||||||p-value for protocol-defined objective response.|Chi-squared, Corrected|||2-sample test for equality of proportions with continuity correction (Pearson's chi-square test statistic) comparing Wildtype and Mutant CSF3R status for protocol-defined objective response||||0.003
71003227|NCT02092324|141514278|EQUIVALENCE|2-sample test for equality of proportions with continuity correction (Pearson's chi-square)||||||0.1||||||p-value for IWG-defined objective response = 0.1|Fisher Exact|||2-sample test for equality of proportions with continuity correction (Pearson's chi-square test statistic) comparing Wildtype and Mutant CSF3R status for IWG-defined objective response||||0.1
71003228|NCT02512276|141514279|SUPERIORITY||Mean Difference (Net)|4.7|||||TWO_SIDED|95.0|3.0|6.4||||||||6.4|3.0|
71043260|NCT01610063|141595668|OTHER|||||||0.002|||||||t-test, 2 sided|||Comparison for PHQ-9||||0.002
71043261|NCT03069417|141595724|SUPERIORITY|Conducted at post-treatment time point.||||||0.11|||||||Mixed Models Analysis|||||||0.11
71043262|NCT03069417|141595724|SUPERIORITY|Conducted at 3-month follow-up time point.||||||0.56|||||||Mixed Models Analysis|||||||0.56
70924636|NCT04321031|141342038|SUPERIORITY||Risk Difference (RD)|0.07|||||TWO_SIDED|90.0|-0.12|0.27||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.27|-0.12|
71003229|NCT02512276|141514280|SUPERIORITY||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.91|1.22||||||||1.22|0.91|
71003230|NCT02512276|141514281|SUPERIORITY||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.94|1.28||||||||1.28|0.94|
71003231|NCT02512276|141514282|SUPERIORITY||Odds Ratio (OR)|0.62|||||TWO_SIDED|95.0|0.45|0.85||||||||0.85|0.45|
71003232|NCT02512276|141514283|SUPERIORITY||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.91|1.36||||||||1.36|0.91|
71003233|NCT02512276|141514284|SUPERIORITY||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.78|1.34||||||||1.34|0.78|
71003234|NCT02725268|141514343|SUPERIORITY||Hazard Ratio (HR)|0.8|||=|0.178|TWO_SIDED|95.0|0.58|1.12||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||1.12|0.58|=0.178
71003235|NCT02725268|141514343|SUPERIORITY||Hazard Ratio (HR)|1.85|||=|0.092|TWO_SIDED|95.0|1.19|2.86||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||2.86|1.19|=0.092
71003236|NCT02725268|141514343|SUPERIORITY||Hazard Ratio (HR)|2.57|||=|0.147|TWO_SIDED|95.0|1.47|4.49||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||4.49|1.47|=0.147
71003237|NCT02725268|141514345|SUPERIORITY||Hazard Ratio (HR)|1.04|||=|0.968|TWO_SIDED|95.0|0.72|1.5||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||1.50|0.72|=0.968
71003238|NCT02725268|141514345|SUPERIORITY||Hazard Ratio (HR)|1.5|||=|0.145|TWO_SIDED|95.0|0.95|2.37||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||2.37|0.95|=0.145
71003239|NCT02725268|141514345|SUPERIORITY||Hazard Ratio (HR)|1.54|||=|0.243|TWO_SIDED|95.0|0.87|2.73||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||2.73|0.87|=0.243
71003240|NCT02725268|141514346|SUPERIORITY||Hazard Ratio (HR)|0.79|||=|0.17|TWO_SIDED|95.0|0.57|1.11||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||1.11|0.57|=0.170
71003241|NCT02725268|141514346|SUPERIORITY||Hazard Ratio (HR)|1.67|||=|0.224|TWO_SIDED|95.0|1.04|2.68||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||2.68|1.04|=0.224
71043263|NCT03069417|141595725|SUPERIORITY|Main effect for time calculated at 3-month follow-up time point.|Fixed effects coefficient (β)|-12.7|||<|0.05|TWO_SIDED|95.0|-22.29|-3.15||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||||-3.15|-22.29|< 0.05
71043264|NCT03069417|141595726|SUPERIORITY|Interaction evaluated at post-treatment time point.|Fixed effects coefficient (β)|-11.1|||<|0.005|TWO_SIDED|95.0|-18.41|-3.83||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||||-3.83|-18.41|< 0.005
71043265|NCT03069417|141595726|SUPERIORITY|Main effect for time at 3-month follow-up time point.|Fixed effects coefficient (β)|-13.8|||<|0.005|TWO_SIDED|95.0|-22.5|-5.17||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||||-5.17|-22.50|< 0.005
71043266|NCT03069417|141595728|SUPERIORITY|Main effect for condition.|Fixed effects coefficient (β)|-10.1|||<|0.05|TWO_SIDED|95.0|-19.58|-0.67||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||||-0.67|-19.58|< 0.05
71043267|NCT03069417|141595728|SUPERIORITY|Main effect for time at post-treatment time point.|Fixed effects coefficient (β)|-12.8|||<|0.01|TWO_SIDED|95.0|-22.14|-3.37||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||||-3.37|-22.14|< 0.01
71003242|NCT02725268|141514346|SUPERIORITY||Hazard Ratio (HR)|2.28|||=|0.244|TWO_SIDED|95.0|1.32|3.96||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||3.96|1.32|=0.244
71003243|NCT02725268|141514347|SUPERIORITY||Odds Ratio (OR)|1.39|||||TWO_SIDED|95.0|0.66|2.9|||||The odds ratio and 95% confidence intervals were obtained using a stratified Cochran-Mantel-Haenszel (CMH) model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||2.90|0.66|
71003244|NCT02725268|141514347|SUPERIORITY||Odds Ratio (OR)|0.22|||||TWO_SIDED|95.0|0.04|1.14|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||1.14|0.04|
71003245|NCT02725268|141514347|SUPERIORITY||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||0.00|0.00|
71003246|NCT02725268|141514348|SUPERIORITY||Odds Ratio (OR)|3.02|||||TWO_SIDED|95.0|1.53|5.96|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||5.96|1.53|
71003247|NCT02725268|141514348|SUPERIORITY||Odds Ratio (OR)|0.4|||||TWO_SIDED|95.0|0.18|0.86|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||0.86|0.18|
71003248|NCT02725268|141514348|SUPERIORITY||Odds Ratio (OR)|0.43|||||TWO_SIDED|95.0|0.15|1.21|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||1.21|0.15|
71003249|NCT02725268|141514349|SUPERIORITY||Odds Ratio (OR)|2.62|||||TWO_SIDED|95.0|0.89|7.67|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||7.67|0.89|
71003250|NCT02725268|141514349|SUPERIORITY||Odds Ratio (OR)|0.15|||||TWO_SIDED|95.0|0.05|0.51|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||0.51|0.05|
71003251|NCT02725268|141514349|SUPERIORITY||Odds Ratio (OR)|0.07|||||TWO_SIDED|95.0|0.01|0.67|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||0.67|0.01|
71003252|NCT04498468|141514350|SUPERIORITY||Mean Difference (Final Values)|-0.55||||0.003|TWO_SIDED|95.0|-0.91|-0.19|||t-test, 2 sided|||Corneal staining analysis, day 28.||-0.19|-0.91|0.003
71003253|NCT04498468|141514350|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.19|TWO_SIDED|95.0|-1.28|0.28|||t-test, 2 sided|||Corneal staining sub-group analysis, day 28, 18-59 year old subgroup.||0.28|-1.28|0.19
71003254|NCT04498468|141514350|SUPERIORITY||Mean Difference (Final Values)|-0.94||||0.047|TWO_SIDED|95.0|-1.86|-0.02|||t-test, 2 sided|||Corneal staining sub-group analysis, day 28, 60+ year old subgroup.||-0.02|-1.86|0.047
71003255|NCT04498468|141514350|SUPERIORITY||Mean Difference (Final Values)|-0.69||||0.08|TWO_SIDED|95.0|-1.49|0.1|||t-test, 2 sided|||Corneal staining sub-group analysis, day 28, Sjogren's subgroup.||0.10|-1.49|0.08
71003256|NCT04498468|141514350|SUPERIORITY||Mean Difference (Final Values)|-0.77||||0.09|TWO_SIDED|95.0|-1.67|0.14|||t-test, 2 sided|||Corneal staining sub-group analysis, day 28, non-Sjogren's subgroup.||0.14|-1.67|0.09
71003257|NCT04498468|141514350|SUPERIORITY||Mean Difference (Final Values)|-0.68|||<|0.001|TWO_SIDED|95.0|-1.05|-0.3|||t-test, 2 sided|||Conjunctival staining analysis, day 28||-0.30|-1.05|< 0.001
71003258|NCT04498468|141514350|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.58|TWO_SIDED|95.0|-1.04|0.61|||t-test, 2 sided|||Conjunctival staining sub-group analysis, day 28, 18-59 year old subgroup.||0.61|-1.04|0.58
71043268|NCT03069417|141595729|SUPERIORITY|Main effect for condition.|Fixed effects coefficient (β)|6.2|||<|0.05|TWO_SIDED|95.0|0.5|11.88||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||||11.88|0.50|< 0.05
71043269|NCT01867606|141595732|SUPERIORITY|||||||0.29|||||||Fisher Exact|||||||0.29
71003259|NCT04498468|141514350|SUPERIORITY||Mean Difference (Final Values)|-1.19||||0.021|TWO_SIDED|95.0|-2.17|-0.21|||t-test, 2 sided|||Conjunctival staining sub-group analysis, day 28, 60+ year old subgroup.||-0.21|-2.17|0.021
71003260|NCT04498468|141514350|SUPERIORITY||Mean Difference (Final Values)|-0.77||||0.16|TWO_SIDED|95.0|-1.88|0.34|||t-test, 2 sided|||Conjunctival staining sub-group analysis, day 28, Sjogren's subgroup.||0.34|-1.88|0.16
71043270|NCT01867606|141595734|SUPERIORITY|||||||0.62|||||||Chi-squared|||||||0.62
71043271|NCT02248662|141595754|OTHER|The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|Odds Ratio (OR)|1.0|||<|0.05|TWO_SIDED|95.0||||A two-sided p value of less than 0.05 was considered to indicate statistical significance.|Regression, Logistic|Adjusted percentages for receipt of mastectomy were calculated by setting covariates to their observed mean values.|This group is the reference group.|Unadjusted associations between patient characteristics and the three-level cluster of treatment intensity for primary DCIS were evaluated using Chi-squared tests. We used multivariable modeling to adjust for potential confounders. We also conducted a sensitivity analysis using propensity score matching to balance regional treatment intensity for primary DCIS with respect to the covariates included in the multivariable models.||||<0.05
71043272|NCT02248662|141595754|OTHER|The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|Odds Ratio (OR)|1.05|||<|0.05|TWO_SIDED|95.0|0.71|1.56||A two-sided p value of less than 0.05 was considered to indicate statistical significance.|Chi-squared|||Unadjusted associations between patient characteristics and the three-level cluster of treatment intensity for primary DCIS were evaluated using Chi-squared tests. We used multivariable modeling to adjust for potential confounders. We also conducted a sensitivity analysis using propensity score matching to balance regional treatment intensity for primary DCIS with respect to the covariates included in the multivariable models.||1.56|0.71|<0.05
71043273|NCT02248662|141595754|OTHER||Odds Ratio (OR)|1.9|||<|0.05|TWO_SIDED|95.0|1.27|2.84|||Chi-squared|||||2.84|1.27|<0.05
71043274|NCT03234608|141595758|SUPERIORITY||Slope|0.18|STANDARD_ERROR_OF_MEAN|0.32||0.56|TWO_SIDED|95.0|-0.44|0.81||The threshold for statistical significance was p\<0.05.|Regression, Linear|||||0.81|-0.44|0.56
71003261|NCT04498468|141514350|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.097|TWO_SIDED|95.0|-1.55|0.14|||t-test, 2 sided|||Conjunctival staining sub-group analysis, day 28, non-Sjogren's subgroup.||0.14|-1.55|0.097
71043275|NCT03234608|141595759|SUPERIORITY||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.79||0.73|TWO_SIDED|95.0|-1.28|1.84||The threshold for statistical significance was p\<0.05.|Regression, Linear|||||1.84|-1.28|0.73
71043276|NCT03234608|141595760|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.17||0.94|TWO_SIDED|95.0|-0.35|0.33||The threshold for statistical significance was p\<0.05.|Regression, Linear|||Statistical analysis for Individual Level Healthcare Self-Efficacy Sub-scale.||0.33|-0.35|0.94
71043277|NCT03234608|141595760|SUPERIORITY||Slope|0.1|STANDARD_ERROR_OF_MEAN|0.21||0.65|TWO_SIDED|95.0|-0.33|0.52|||Regression, Linear|||Statistical analysis for Relationship-Dependent Healthcare Self-Efficacy Sub-scale||0.52|-0.33|0.65
71043278|NCT03234608|141595761|SUPERIORITY||Slope|-0.23|STANDARD_ERROR_OF_MEAN|0.52||0.66|TWO_SIDED|95.0|-1.25|0.79||The threshold for statistical significance was p\<0.05.|Regression, Linear|||||0.79|-1.25|0.66
71003262|NCT04498468|141514351|SUPERIORITY||Mean Difference (Final Values)|-5.5||||0.069|TWO_SIDED|95.0|-11.4|0.4|||t-test, 2 sided|||Eye dryness, day 28||0.4|-11.4|0.069
71003263|NCT04498468|141514351|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.92|TWO_SIDED|95.0|-7.0|6.3|||t-test, 2 sided|||VAS Eye discomfort, Day 28||6.3|-7.0|0.92
71003264|NCT04498468|141514351|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.55|TWO_SIDED|95.0|-5.8|3.1|||t-test, 2 sided|||VAS eye fatigue, day 28||3.1|-5.8|0.55
71003265|NCT04498468|141514352|SUPERIORITY||Risk Ratio (RR)|1.26||||0.42|TWO_SIDED|95.0|0.8|2.0|||McNemar|||||2.0|0.8|0.42
71003266|NCT04498468|141514353|SUPERIORITY||Risk Ratio (RR)|1.04||||1|TWO_SIDED|95.0|0.76|1.42|||McNemar|||||1.42|0.76|1.00
71043279|NCT03234608|141595762|SUPERIORITY||Slope|0.15|STANDARD_ERROR_OF_MEAN|0.78||0.85|TWO_SIDED|95.0|-1.4|1.69||The threshold for statistical significance was p\<0.05.|Regression, Linear|||||1.69|-1.40|0.85
71043280|NCT02105701|141595766|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR12 rate \>58%.||||<0.001
71043281|NCT02105701|141595766|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR12 rate \>58%.||||<0.001
71043282|NCT02105701|141595766|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR12 rate \>58%.||||<0.001
71043283|NCT02105701|141595766|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR12 rate \>58%.||||<0.001
71043284|NCT02105701|141595769|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR24 rate \>58%.||||<0.001
71043285|NCT02105701|141595769|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR24 rate \>58%.||||<0.001
71043286|NCT02105701|141595769|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR24 rate \>58%.||||<0.001
71043287|NCT02105701|141595769|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR24 rate \>58%.||||<0.001
71101059|NCT03726879|141709934|SUPERIORITY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.24|1.36|||Log Rank|||ER/PgR Positive Participants||1.36|0.24|
71101060|NCT03726879|141709935|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.38|1.32|||Log Rank|||All Participants||1.32|0.38|
71101061|NCT03726879|141709935|SUPERIORITY||Hazard Ratio (HR)|1.38|||||TWO_SIDED|95.0|0.51|3.69|||Log Rank|||PD-L1 IC1/2/3||3.69|0.51|
71101062|NCT03726879|141709935|SUPERIORITY||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.19|1.02|||Log Rank|||PD-L1 IC0||1.02|0.19|
71101063|NCT03726879|141709936|SUPERIORITY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.4|2.0|||Log Rank|||All Participants||2.00|0.40|
71101064|NCT03726879|141709936|SUPERIORITY||Hazard Ratio (HR)|1.75|||||TWO_SIDED|95.0|0.42|7.33|||Log Rank|||PD-L1 IC1/2/3||7.33|0.42|
71101065|NCT03726879|141709936|SUPERIORITY||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.21|1.59|||Log Rank|||PD-L1 IC0||1.59|0.21|
71101066|NCT03726879|141709950|SUPERIORITY||Hazard Ratio (HR)|2.38|||||TWO_SIDED|95.0|0.22|26.42|||Regression, Cox|||PIK3CA-Missing||26.42|0.22|
71101067|NCT03726879|141709950|SUPERIORITY||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.23|1.9|||Regression, Cox|||PIK3CA-Mutated||1.90|0.23|
71101068|NCT03726879|141709950|SUPERIORITY||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.45|1.87|||Regression, Cox|||PIK3CA-Wildtype||1.87|0.45|
71101069|NCT03726879|141709951|SUPERIORITY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.07|18.91|||Regression, Cox|||PIK3CA-Missing||18.91|0.07|
71101070|NCT03726879|141709951|SUPERIORITY||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.19|1.92||||||PIK3CA-Mutated||1.92|0.19|
71101071|NCT03726879|141709951|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.33|1.55|||Regression, Cox|||PIK3CA-Wildtype||1.55|0.33|
71101072|NCT03726879|141709952|SUPERIORITY||Hazard Ratio (HR)|999.99|||||TWO_SIDED|95.0|0.0||Upper limit of the CI was not evaluable due to low number of events||Regression, Cox||The estimated value is \>999.99|PIK3CA-Missing|||0.00|
71101073|NCT03726879|141709952|SUPERIORITY||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.1|3.53|||Regression, Cox|||PIK3CA-Mutated||3.53|0.10|
71101074|NCT03726879|141709952|SUPERIORITY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.33|2.09|||Regression, Cox|||PIK3CA-Wildtype||2.09|0.33|
71101075|NCT03708770|141709971|OTHER|No power calculation was performed for this study.||||||||||||||||"This was not a hypothesis-driven study. Therefore, there were no primary effectiveness or safety endpoints.~The Secondary Patency endpoint was calculated using a Kaplan-Meier analysis."|The Secondary Patency rate was determined via Kaplan-Meier methods.|||
71101076|NCT03708770|141709972|OTHER|No power calculation was performed for this study.||||||||||||||||"This was not a hypothesis-driven study. Therefore, there were no primary effectiveness or safety endpoints.~The Primary Patency endpoint was calculated using a Kaplan-Meier analysis."|The primary patency rate was determined via Kaplan-Meier methods.|||
71101077|NCT02457546|141709976|NON_INFERIORITY|"The statistical hypothesis for testing the treatment difference was presented as follows:~H0: Δ ≤ -0.10 tested against the alternative hypothesis Ha: Δ \> -0.10. where:~* Δ is the difference between the success rates of Experimental (Evicel®) and Control (DuraSeal™) (Experimental minus Control)~* -0.10 is the non-inferiority difference PC is the proportion of success in DuraSeal™ Control subjects and PE is the proportion of success in EVICEL® subjects."|Difference in Success Rates|6.3|||||TWO_SIDED|95.0|-1.8|14.4||||||||14.4|-1.8|
71101078|NCT01500135|141710013|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62|STANDARD_ERROR_OF_MEAN|0.72||0.276|TWO_SIDED|95.0|0.68|3.88||Logistic regression model with treatment, type of surgery (Peripheral Arterial Disease, Arterio Venous Graft) and current use of Clopidogrel or other similar anti-platelet drugs (yes/no) as covariates.|Regression, Logistic|||||3.88|0.68|0.276
71101079|NCT01500135|141710014|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85|STANDARD_ERROR_OF_MEAN|0.33||0.684|TWO_SIDED|95.0|0.4|1.82||Logistic regression model with treatment, type of surgery (Peripheral Arterial Disease, Arterio Venous Graft) and current use of Clopidogrel or other similar anti-platelet drugs (yes/no) as covariates.|Regression, Logistic|||||1.82|0.40|0.684
71101080|NCT01500135|141710015|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14|STANDARD_ERROR_OF_MEAN|0.24||0.684|TWO_SIDED|95.0|0.7|1.8||P-value was adjusted using Hochberg's adjustment for multiplicity.|Proportional Hazard Model|||||1.8|0.7|0.684
71101081|NCT01537432|141710065|SUPERIORITY_OR_OTHER||difference in proportions|0.565|||<|0.001|TWO_SIDED|95.0|0.363|0.768|||Fisher Exact|||||0.768|0.363|<0.001
71101082|NCT03523585|141710080|SUPERIORITY||Hazard Ratio (HR)|0.3589|||<|1e-06|TWO_SIDED|95.0|0.284|0.4535||Stratified Log-rank p-value|Log Rank|p value based on log-rank stratified by hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by IXRS|Hazard Ratio based on stratified Cox proportional hazards model with stratification factors: hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by the IXRS.|||0.4535|0.2840|<0.000001
71003267|NCT00412113|141514365|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|19.03|||<|0.001||95.0|9.14|39.63||There was only one primary endpoint and the p-value was not adjusted for comparison.|Cochran-Mantel-Haenszel|||"Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving both the BP(\< 140/90 mmHg) and LDL goal (\< 100mg/dL) at Week 6.~With \~120 in each treatment arm, planned power was at least 90% to detect a difference between treatments, assuming 35% in the Caduet and 15% in the Norvasc arm achieving BP \<140/90 mmHg and LDL \<100 mg/dL and using a chi-square test with 0.05 two-sided significance level."||39.63|9.14|<0.001
71003268|NCT00412113|141514366|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|31.39|||<|0.001||95.0|12.61|78.09||No adjustment for p-value for secondary analysis|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving both the blood pressure (\< 140/90 mmHg) and LDL-goal (\<100 mg/dL) at Week 4.||78.09|12.61|<0.001
71003269|NCT00412113|141514367|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.2|||<|0.001||95.0|2.93|9.24||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving both the blood pressure (\< 140/90 mmHg) and LDL-goal (\<130mg/dL) at Week 4.||9.24|2.93|<0.001
71003270|NCT00412113|141514368|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.14|||<|0.001||95.0|2.89|9.11||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving both the blood pressure (\< 140/90 mmHg) and LDL-goal (\<130mg/dL) at Week 6.||9.11|2.89|<0.001
71003271|NCT00412113|141514369|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|65.51|||<|0.001||95.0|27.1|158.34||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving (\<100mg/DL) at Week 4.||158.34|27.10|<0.001
71003272|NCT00412113|141514370|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|42.04|||<|0.001||95.0|19.42|90.99||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving LDL-goal (\<100mg/DL) at Week 6.||90.99|19.42|<0.001
71003273|NCT00412113|141514371|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09||||0.785||95.0|0.6|1.98||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving blood pressure (\< 140/90 mmHg)at Week 4||1.98|0.60|0.785
71003274|NCT00412113|141514372|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.171||95.0|0.83|2.88||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving blood pressure (\< 140/90 mmHg) at Week 6.||2.88|0.83|0.171
71003275|NCT00412113|141514373|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.76||||0.585||95.0|-1.97|3.48||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in systolic blood pressure at Week 4.||3.48|-1.97|0.585
71043288|NCT02148445|141595770|SUPERIORITY|Based on prior studies using precessation NRT, we estimate a 2-fold increase in cessation outcomes in the GMT group compared to the SC group. Given our recruitment of patients at all levels of readiness to quit, we estimate a 12 month cessation rate of 10%. With 199 participants, in each arm, we will have an 80% power to detect a 2-fold difference or greater with a Type I error rate of 5%.||||||0.88|||||||Chi-squared|||||||0.88
71043289|NCT02148445|141595771|SUPERIORITY|Based on prior studies using precessation NRT, we estimate a 2-fold increase in cessation outcomes in the GMT group compared to the SC group. Given our recruitment of patients at all levels of readiness to quit, we estimate a 12 month cessation rate of 10%. With 199 participants, in each arm, we will have an 80% power to detect a 2-fold difference or greater with a Type I error rate of 5%. This sample size will provide comparable power for looking at 6 month sustained cessation.||||||0.55|||||||Chi-squared|||||||0.55
71101083|NCT03523585|141710081|SUPERIORITY||Hazard Ratio (HR)|0.6575||||0.0021|TWO_SIDED|95.0|0.5023|0.8605||Stratified Log-rank p-value|Log Rank|p value based on log-rank stratified by hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by IXRS|Hazard Ratio based on stratified Cox proportional hazards model with stratification factors: hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by the IXRS.|||0.8605|0.5023|0.0021
71003276|NCT00412113|141514374|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.0|||>|0.999||95.0|-2.01|2.01||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in diastolic blood pressure at Week 4.||2.01|-2.01|> 0.999
71003277|NCT00412113|141514375|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.9||||0.363||95.0|-2.83|1.04|||ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in pulse rate at Week 4.||1.04|-2.83|0.363
71003278|NCT00412113|141514376|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-3.25||||0.02||95.0|-5.99|-0.51||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in systolic blood pressure at Week 6.||-0.51|-5.99|0.020
71003279|NCT00412113|141514377|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.87||||0.351||95.0|-2.71|0.97||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in diastolic blood pressure at Week 6.||0.97|-2.71|0.351
71003280|NCT00412113|141514378|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.1||||0.922||95.0|-1.91|2.11||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in mean change from baseline in pulse rate at Week 6.||2.11|-1.91|0.922
71101084|NCT03523585|141710082|SUPERIORITY||||||<|0.0001||||||Cochran-Mantel-Haenszel test adjusted for stratification factors: hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by the IXRS.|Cochran-Mantel-Haenszel|||Statistical Analysis for BICR Assessment||||<0.0001
71003281|NCT00412113|141514379|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-49.3|||<|0.001||95.0|-54.68|-43.91||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in LDL at Week 4.||-43.91|-54.68|<0.001
71043290|NCT02148445|141595772|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||||||0.40
71043291|NCT02148445|141595773|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71043292|NCT02148445|141595774|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71043293|NCT02148445|141595775|SUPERIORITY|||||||0.39|||||||Mixed Models Analysis|||||||0.39
71043294|NCT02148445|141595776|SUPERIORITY|||||||0.42|||||||t-test, 1 sided|||||||0.42
71043295|NCT02148445|141595777|SUPERIORITY|||||||0.27|||||||Mixed Models Analysis|||||||0.27
71043296|NCT02148445|141595778|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|||||||0.06
71043297|NCT02148445|141595780|SUPERIORITY|||||||0.08|||||||Chi-squared|||Month 3 self-reported abstinence||||0.08
71043298|NCT02148445|141595780|SUPERIORITY|||||||0.06|||||||Chi-squared|||Month 3 biochemically verified abstinence||||0.06
71043299|NCT02148445|141595780|SUPERIORITY|||||||0.22|||||||Chi-squared|||Month 6, self-reported abstinence||||0.22
71043300|NCT02148445|141595780|SUPERIORITY|||||||0.34|||||||Chi-squared|||Month 6, biochemically verified abstinence||||0.34
71043301|NCT02148445|141595780|SUPERIORITY|||||||0.66|||||||Chi-squared|||Month 12, self-reported abstinence||||0.66
71043302|NCT02148445|141595781|SUPERIORITY|||||||0.0149|||||||Mixed Models Analysis|||||||0.0149
71043303|NCT02148445|141595782|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71043304|NCT02148445|141595783|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||0.08
71043305|NCT02148445|141595784|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||||||0.77
71043306|NCT02148445|141595785|SUPERIORITY|||||||0.0918|||||||Mixed Models Analysis|||||||0.0918
71043307|NCT03450629|141595786|EQUIVALENCE|8 AM +/- 30 min||||||0.0006|||||||t-test, 2 sided|||||||0.0006
71043308|NCT03450629|141595786|EQUIVALENCE|10 AM +/- 30 min||||||0.0291|||||||t-test, 2 sided|||||||0.0291
71043309|NCT03450629|141595786|EQUIVALENCE|4 PM +/- 30 min||||||0.0002|||||||t-test, 2 sided|||||||0.0002
71043310|NCT04230876|141595789|SUPERIORITY||partial eta squared|0.047|||=|0.269|TWO_SIDED|||||Within the 28 participants, changes in the COSI scores after four weeks using the Amptify were compared to the changes after four weeks watching 20 minutes of CC TV (F(1,26)=1.28).|ANOVA|||||||=0.269
71043311|NCT04230876|141595790|SUPERIORITY||partial eta squared|0.031|||=|0.401|TWO_SIDED|||||Changes in the IOI-HA scores measured after four weeks using the Amptify were compared to the changes seen after four weeks of CC TV every day (F(1,23)=.733).|ANOVA|||||||=0.401
71043312|NCT04230876|141595791|SUPERIORITY||partial eta squared|0.0|||=|0.968|TWO_SIDED|||||Changes in the APHAB benefit scores after four weeks using the Amptify were compared to the improvements seen after four weeks of CC TV every day (F(1,25)=.002).|ANOVA|||||||=0.968
71043313|NCT04230876|141595792|SUPERIORITY||partial eta squared|0.028|||=|0.392|TWO_SIDED|||||Changes in the SSQ-12 scores after four weeks using the Amptify were compared to the improvements seen after four weeks watching 20 minutes of CC TV (F(1,26)=.756).|ANOVA|||||||=0.392
71043314|NCT04230876|141595793|SUPERIORITY||partial eta squared|0.005|||=|0.72|TWO_SIDED|||||Among the 28 participants, changes in the hours per day of hearing aid usage seen after four weeks using the Amptify were compared to the changes seen after four weeks of CC TV every day (F(1,26)=.131).|ANOVA|||||||=0.720
71043315|NCT04230876|141595794|SUPERIORITY||partial eta squared|0.052|||=|0.242|TWO_SIDED|||||Changes in the NU-6 seen after four weeks using the Amptify were compared to the changes seen after four weeks watching 20 minutes of CC TV (F(1,26)=1.43).|ANOVA|||||||=0.242
71043316|NCT00739973|141595795|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-9.97|STANDARD_ERROR_OF_MEAN|1.45|<|0.001|TWO_SIDED|95.0|-12.81|-7.12|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-7.12|-12.81|<0.001
71043317|NCT00739973|141595796|SUPERIORITY_OR_OTHER||Least Square mean Difference|-4.82|STANDARD_ERROR_OF_MEAN|1.47||0.001|TWO_SIDED|95.0|-7.7|-1.94|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-1.94|-7.70|0.001
71043318|NCT00739973|141595797|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-13.85|STANDARD_ERROR_OF_MEAN|1.44|<|0.001|TWO_SIDED|95.0|-16.68|-11.0|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-11.0|-16.68|<0.001
71101085|NCT03523585|141710082|SUPERIORITY||||||<|0.0001||||||Cochran-Mantel-Haenszel test adjusted for stratification factors: hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by the IXRS.|Cochran-Mantel-Haenszel|||Statistical Analysis for Investigator Assessment||||<0.0001
71003282|NCT00412113|141514380|SUPERIORITY_OR_OTHER_LEGACY||difference in LS Means|-0.3||||0.739||95.0|-2.07|1.47||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in HDL at Week 4.||1.47|-2.07|0.739
71003283|NCT00412113|141514381|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-57.9|||<|0.001||95.0|-64.02|51.81||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in TC at Week 4.||51.81|-64.02|<0.001
71003284|NCT00412113|141514382|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-47.27|||<|0.001||95.0|-63.37|-31.16||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in TG at Week 4.||-31.16|-63.37|<0.001
71003285|NCT00412113|141514383|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-51.21|||<|0.001||95.0|-56.88|-45.55||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in LDL at Week 6.||-45.55|-56.88|<0.001
71101086|NCT03523585|141710084|SUPERIORITY||Hazard Ratio (HR)|0.2828|||<|1e-06|TWO_SIDED|95.0|0.227|0.3524||Stratified Log-rank p-value.|Log Rank|p value based on log-rank stratified by hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by IXRS|Hazard Ratio based on stratified Cox proportional hazards model with stratification factors: hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by the IXRS.|||0.3524|0.2270|<0.000001
71101087|NCT03704922|141710143|OTHER|||||||0.051|||||||Fisher Exact|||||||0.051
71101088|NCT00830336|141710216|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Geometric Test/Ref Ratio x 100|103.08||||||90.0|95.41|111.37|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111.37|95.41|
71101089|NCT00830336|141710217|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Geometric Test/Ref Ratio x 100|105.84||||||90.0|99.33|112.77|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||112.77|99.33|
71101090|NCT00830336|141710218|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Geometric Test/Ref Ratio x 100|107.04||||||90.0|99.96|114.62|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||114.62|99.96|
71101091|NCT04526158|141710286|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.031|TWO_SIDED|95.0|0.0|0.6||significance threshold = 0.0167 due to multiple comparisons|Mixed Models Analysis|Linear mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.6|0.0|0.031
71101092|NCT04526158|141710286|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.002|TWO_SIDED|95.0|-0.7|-0.2||significance threshold = 0.0167 due to multiple comparisons|Mixed Models Analysis|Linear mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-0.7|0.002
71101093|NCT04526158|141710286|SUPERIORITY||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.0|-0.4||significance threshold = 0.0167 due to multiple comparisons|Mixed Models Analysis|Linear mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.4|-1.0|<0.001
71101094|NCT04526158|141710287|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.736|TWO_SIDED|95.0|-0.2|0.3|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of BPI intensity, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.3|-0.2|0.736
71101095|NCT04526158|141710287|SUPERIORITY||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.6|-0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of BPI intensity, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-0.6|<0.001
71101096|NCT04526158|141710287|SUPERIORITY||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.7|-0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of BPI intensity, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-0.7|<0.001
71101097|NCT04526158|141710288|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.829|TWO_SIDED|95.0|-0.4|0.4|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS Physical function, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.4|-0.4|0.829
71003286|NCT00412113|141514384|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.02||||0.329||95.0|-3.07|1.03||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in HDL at Week 6.||1.03|-3.07|0.329
71003287|NCT00412113|141514385|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-62.07|||<|0.001||95.0|-68.49|-55.65||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in TC at Week 6.||-55.65|-68.49|<0.001
71101098|NCT04526158|141710288|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.005|TWO_SIDED|95.0|0.2|0.9|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS Physical function, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.9|0.2|0.005
71003288|NCT00412113|141514386|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-53.95|||<|0.001||95.0|-77.61|-30.29||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change in TG from baseline in at Week 6.||-30.29|-77.61|<0.001
71003289|NCT00412113|141514387|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.4|||<|0.001||95.0|-3.1|-1.7||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in mean change from baseline to Week 4 in Framingham predicted absolute 10-year risk.||-1.7|-3.1|<0.001
71003290|NCT00412113|141514388|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.8|||<|0.001||95.0|-3.5|-2.1||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline to Week 6 in Framingham predicted absolute 10-year risk.||-2.1|-3.5|<0.001
71003291|NCT01627782|141514398|SUPERIORITY_OR_OTHER_LEGACY||Difference of Least Square Means|-16.0|||<|0.001|TWO_SIDED|70.0|-20.0|-12.01|||Mixed Effect Model Repeated Measure|||||-12.01|-20.00|< 0.001
71003292|NCT01627782|141514398|SUPERIORITY_OR_OTHER_LEGACY||Difference of Least Square Means|-16.4|||<|0.001|TWO_SIDED|70.0|-18.96|-13.84|||Mixed Effect Model Repeated Measure|||||-13.84|-18.96|< 0.001
71003293|NCT00616772|141514428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006||||0.22|TWO_SIDED|95.0|-0.016|0.004|||Repeated measures linear mixed model|Fixed effects for baseline cIMT, baseline atorvastatin dose, central imaging site, treatment group, time; interaction between treatment group and time||||0.004|-0.016|0.220
71003294|NCT00616772|141514429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002||||0.813|TWO_SIDED|95.0|-0.014|0.011|||Repeated measures linear mixed model|Fixed effects for baseline atorvastatin dose, imaging site, treatment, time; interaction between treatment group and time; baseline cIMT as covariate.||||0.011|-0.014|0.813
71003295|NCT00616772|141514430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007||||0.249|TWO_SIDED|95.0|-0.018|0.005|||Repeated measures linear mixed model|Fixed effects for baseline atorvastatin dose, imaging site, treatment, time; interaction between treatment group and time; baseline IMT as covariate||||0.005|-0.018|0.249
71003296|NCT00616772|141514431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005||||0.487|TWO_SIDED|95.0|-0.02|0.01|||Repeated measures linear mixed model|Fixed effects for baseline atorvastatin dose, imaging site, treatment, time; interaction between treatment group and time; baseline IMT as covariate||||0.010|-0.020|0.487
71003297|NCT00616772|141514432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016||||0.112|TWO_SIDED|95.0|-0.004|0.035|||Repeated measures linear mixed model|Fixed effects for baseline atorvastatin dose, imaging site, treatment, time; interaction between treatment group and time; baseline IMT as covariate||||0.035|-0.004|0.112
71003298|NCT04315298|141514451|SUPERIORITY||LS Mean (log scale)|-1.25|STANDARD_ERROR_OF_MEAN|0.107|<|0.0001|TWO_SIDED|95.0|-1.456|-1.035||P-value is based on the ANCOVA model for differences between treatment groups in terms of \[ln(CRP at day 4 ) - ln(baseline CRP)\].|ANCOVA|||||-1.035|-1.456|<0.0001
71003299|NCT04315298|141514451|SUPERIORITY||LS Mean (log scale)|-1.3|STANDARD_ERROR_OF_MEAN|0.107|<|0.0001|TWO_SIDED|95.0|-1.511|-1.09||p-value is based on the ANCOVA model for differences between treatment groups in terms of \[ln(CRP at day 4 ) - ln(baseline CRP)\].|ANCOVA|||||-1.090|-1.511|<0.0001
71003300|NCT04315298|141514452|SUPERIORITY||Risk Difference (RD)|7.1||||0.3707|TWO_SIDED|95.0|-8.4|21.7||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||21.7|-8.4|0.3707
71003301|NCT04315298|141514452|SUPERIORITY||Risk Difference (RD)|7.5||||0.3261|TWO_SIDED|95.0|-7.4|21.3||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||21.3|-7.4|0.3261
71003302|NCT04315298|141514453|SUPERIORITY||Risk Difference (RD)|6.2||||0.7328|TWO_SIDED|95.0|-26.2|36.8|||Cochran-Mantel-Haenszel|P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline||||36.8|-26.2|0.7328
71003303|NCT04315298|141514454|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.5687|TWO_SIDED|95.0|0.76|1.66||P-value based on log-rank test stratified by disease severity (severe, critical) and use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.66|0.76|0.5687
71003304|NCT04315298|141514454|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.7014|TWO_SIDED|95.0|0.74|1.62||P-value based on log-rank test stratified by disease severity (severe, critical) and use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.62|0.74|0.7014
71003305|NCT04315298|141514455|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.3622|TWO_SIDED|95.0|0.83|1.7||P-value based on log-rank test stratified by disease severity (severe, critical) and use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.70|0.83|0.3622
71003306|NCT04315298|141514455|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.5802|TWO_SIDED|95.0|0.79|1.63||P-value based on log-rank test stratified by disease severity (severe, critical) and use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.63|0.79|0.5802
71003307|NCT04315298|141514456|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.234|TWO_SIDED|95.0|0.83|2.02||P-value based on log-rank test stratified by disease severity (severe, critical and MSOD) and use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||2.02|0.83|0.2340
71003308|NCT04315298|141514456|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.6949|TWO_SIDED|95.0|0.74|1.79||P-value based on log-rank test stratified by disease severity (severe, critical and MSOD) and use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.79|0.74|0.6949
71003309|NCT04315298|141514457|SUPERIORITY||Hazard Ratio (HR)|1.27||||0.3151|TWO_SIDED|95.0|0.66|2.43||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||2.43|0.66|0.3151
71003310|NCT04315298|141514457|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.1884|TWO_SIDED|95.0|0.39|1.41||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.41|0.39|0.1884
71003311|NCT04315298|141514457|SUPERIORITY||Hazard Ratio (HR)|1.61||||0.4356|TWO_SIDED|95.0|0.76|3.4||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||3.40|0.76|0.4356
71003312|NCT04315298|141514457|SUPERIORITY||Hazard Ratio (HR)|2.1||||0.0371|TWO_SIDED|95.0|1.01|4.4||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||4.40|1.01|0.0371
71003313|NCT04315298|141514457|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.8923|TWO_SIDED|95.0|0.32|3.05||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||3.05|0.32|0.8923
71003314|NCT04315298|141514457|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.694|TWO_SIDED|95.0|0.25|2.71||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||2.71|0.25|0.6940
71003315|NCT04315298|141514458|SUPERIORITY||Hazard Ratio (HR)|2.14||||0.0832|TWO_SIDED|95.0|0.81|5.65||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \< 87.04 pg/mL (median)||5.65|0.81|0.0832
71003316|NCT04315298|141514458|SUPERIORITY||Hazard Ratio (HR)|1.93||||0.1369|TWO_SIDED|95.0|0.77|4.8||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \< 87.04 pg/mL (median)||4.80|0.77|0.1369
71003317|NCT04315298|141514458|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.9636|TWO_SIDED|95.0|0.28|1.95||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \>= 87.04 pg/mL (median)||1.95|0.28|0.9636
71043319|NCT00739973|141595798|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-13.2|STANDARD_ERROR_OF_MEAN|1.45|<|0.001|TWO_SIDED|95.0|-16.04|-10.4|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-10.4|-16.04|<0.001
71003318|NCT04315298|141514458|SUPERIORITY||Hazard Ratio (HR)|0.24||||0.0038|TWO_SIDED|95.0|0.08|0.74||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \>= 87.04 pg/mL (median)||0.74|0.08|0.0038
71003319|NCT04315298|141514458|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.738|TWO_SIDED|95.0|0.47|3.13||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \< 166.68pg/mL (Median)||3.13|0.47|0.7380
71003320|NCT04315298|141514458|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.7342|TWO_SIDED|95.0|0.48|3.05||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \<166.68pg/mL (Median)||3.05|0.48|0.7342
71003321|NCT04315298|141514458|SUPERIORITY||Hazard Ratio (HR)|3.58||||0.1934|TWO_SIDED|95.0|0.79|16.17||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \>= 166.68pg/mL (Median)||16.17|0.79|0.1934
71003322|NCT04315298|141514458|SUPERIORITY||Hazard Ratio (HR)|5.33||||0.0159|TWO_SIDED|95.0|1.19|23.94||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \>= 166.68pg/mL (Median)||23.94|1.19|0.0159
71003323|NCT04315298|141514458|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.6281|TWO_SIDED|95.0|0.13|8.75||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \<254.95 pg/mL (Median)||8.75|0.13|0.6281
71003324|NCT04315298|141514458|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.4971|TWO_SIDED|95.0|0.06|6.13||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \<254.95 pg/mL (Median)||6.13|0.06|0.4971
71003325|NCT04315298|141514458|SUPERIORITY||Hazard Ratio (HR)|0.3||||0.299|TWO_SIDED|95.0|0.03|2.86||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \>= 254.95 pg/mL (Median)||2.86|0.03|0.2990
71003326|NCT04315298|141514458|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.936|TWO_SIDED|95.0|0.22|4.41||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \>= 254.95 pg/mL (Median)||4.41|0.22|0.9360
71003327|NCT04315298|141514459|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.9032|TWO_SIDED|95.0|0.52|1.47||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.47|0.52|0.9032
71003328|NCT04315298|141514459|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.0052|TWO_SIDED|95.0|0.29|0.88||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||0.88|0.29|0.0052
71003329|NCT04315298|141514459|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.1168|TWO_SIDED|95.0|0.48|1.21||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||1.21|0.48|0.1168
71003330|NCT04315298|141514459|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.3753|TWO_SIDED|95.0|0.69|1.72||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||1.72|0.69|0.3753
71003331|NCT04315298|141514459|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.4956|TWO_SIDED|95.0|0.4|1.66||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||1.66|0.40|0.4956
71003332|NCT04315298|141514459|SUPERIORITY||Cox Proportional Hazard|1.01||||0.8439|TWO_SIDED|95.0|0.5|2.02||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||2.02|0.50|0.8439
71003333|NCT04315298|141514460|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.389|TWO_SIDED|95.0|0.52|2.79||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \< 67.11 pg/mL (median)||2.79|0.52|0.3890
71003334|NCT04315298|141514460|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.7838||95.0|0.3|1.41||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \>= 67.11pg/mL (median)||1.41|0.30|0.7838
71003335|NCT04315298|141514460|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.237|TWO_SIDED|95.0|0.28|1.65||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \< 67.11 pg/mL (median)||1.65|0.28|0.2370
71003336|NCT04315298|141514460|SUPERIORITY||Hazard Ratio (HR)|0.25||||0.0004||95.0|0.1|0.59||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \>= 67.11pg/mL (median)||0.59|0.10|0.0004
71003337|NCT04315298|141514460|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.174|TWO_SIDED|95.0|0.37|1.32||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \< 131.90 pg/mL (median)||1.32|0.37|0.1740
71003338|NCT04315298|141514460|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.3664|TWO_SIDED|95.0|0.38|1.66||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \>= 131.90 pg/mL (median)||1.66|0.38|0.3664
71003339|NCT04315298|141514460|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.7318|TWO_SIDED|95.0|0.53|1.87||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \< 131.90 pg/mL (median)||1.87|0.53|0.7318
71003340|NCT04315298|141514460|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.4155|TWO_SIDED|95.0|0.59|2.37||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \>= 131.90 pg/mL (median)||2.37|0.59|0.4155
71003341|NCT04315298|141514460|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.6262|TWO_SIDED|95.0|0.23|2.45||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \< 254.95 pg/mL (median)||2.45|0.23|0.6262
71003342|NCT04315298|141514460|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.553||95.0|0.21|2.3||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \>= 254.95 pg/mL (median)||2.30|0.21|0.5530
71003343|NCT04315298|141514460|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.8775|TWO_SIDED|95.0|0.25|2.85||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \< 254.95 pg/mL (median)||2.85|0.25|0.8775
71043320|NCT00739973|141595799|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-7.77|-4.22|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-4.22|-7.77|<0.001
71043321|NCT00739973|141595800|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.98|STANDARD_ERROR_OF_MEAN|0.91||0.001|TWO_SIDED|95.0|-4.77|-1.19|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-1.19|-4.77|0.001
71043322|NCT00739973|141595801|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-8.63|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-10.39|-6.87|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-6.87|-10.39|<0.001
71101099|NCT04526158|141710288|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.004|TWO_SIDED|95.0|0.2|1.0|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS Physical function, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||1.0|0.2|0.004
71003344|NCT04315298|141514460|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.7485|TWO_SIDED|95.0|0.41|2.99||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \>= 254.95 pg/mL (median)||2.99|0.41|0.7485
71003345|NCT04315298|141514461|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.4556|TWO_SIDED|95.0|0.63|1.79||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.79|0.63|0.4556
71003346|NCT04315298|141514461|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.0248|TWO_SIDED|95.0|0.35|1.04||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.04|0.35|0.0248
71003347|NCT04315298|141514461|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.6842|TWO_SIDED|95.0|0.62|1.67||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||1.67|0.62|0.6842
71003348|NCT04315298|141514461|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.0671|TWO_SIDED|95.0|0.89|2.32||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||2.32|0.89|0.0671
71003349|NCT04315298|141514461|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.6146|TWO_SIDED|95.0|0.41|1.74||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||1.74|0.41|0.6146
71003350|NCT04315298|141514461|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.973|TWO_SIDED|95.0|0.48|1.99||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||1.99|0.48|0.9730
70924637|NCT04321031|141342038|SUPERIORITY||Risk Difference (RD)|0.25|||||TWO_SIDED|90.0|0.04|0.42||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.42|0.04|
71003351|NCT04315298|141514463|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.6987|TWO_SIDED|95.0|0.59|1.59||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.59|0.59|0.6987
71043323|NCT00739973|141595802|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-8.17|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-9.94|-6.4|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-6.40|-9.94|<0.001
71003352|NCT04315298|141514463|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0453|TWO_SIDED|95.0|0.39|1.09||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.09|0.39|0.0453
71003353|NCT04315298|141514463|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.9734|TWO_SIDED|95.0|0.73|2.09||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||2.09|0.73|0.9734
71003354|NCT04315298|141514463|SUPERIORITY||Hazard Ratio (HR)|1.91||||0.004|TWO_SIDED|95.0|1.14|3.2||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No)|Log Rank|||Disease Severity: Critical||3.20|1.14|0.0040
71003355|NCT04315298|141514463|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.9551|TWO_SIDED|95.0|0.43|2.17||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||2.17|0.43|0.9551
71003356|NCT04315298|141514463|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.8722|TWO_SIDED|95.0|0.42|2.1||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||2.10|0.42|0.8722
71043324|NCT00739973|141595803|SUPERIORITY_OR_OTHER||Least Sqaure Mean Difference|-2.33|STANDARD_ERROR_OF_MEAN|0.92||0.011|TWO_SIDED|95.0|-4.14|-0.53|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-0.53|-4.14|0.011
70924638|NCT04321031|141342038|SUPERIORITY||Risk Difference (RD)|0.16|||||TWO_SIDED|50.0|0.08|0.23||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.23|0.08|
70924639|NCT04321031|141342038|SUPERIORITY||Risk Difference (RD)|0.16|||||TWO_SIDED|90.0|-0.03|0.31||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.31|-0.03|
70924640|NCT04321031|141342038|SUPERIORITY||Risk Difference (RD)|0.18|||||TWO_SIDED|50.0|0.09|0.26||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.26|0.09|
71003357|NCT04315298|141514466|SUPERIORITY|||||||1|||||||Chi-squared|||Disease Severity: Severe||||1.0000
71003358|NCT04315298|141514466|SUPERIORITY|||||||0.0353|||||||Chi-squared|||Disease Severity: Severe||||0.0353
71003359|NCT04315298|141514466|SUPERIORITY|||||||0.3187|||||||Chi-squared|||Disease Severity: Critical||||0.3187
71003360|NCT04315298|141514466|SUPERIORITY|||||||0.0261|||||||Chi-squared|||Disease Severity: Critical||||0.0261
71043325|NCT00739973|141595804|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-10.81|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-12.57|-9.05|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-9.05|-12.57|<0.001
71043326|NCT00739973|141595805|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-4.79|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-6.56|-3.03|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-3.03|-6.56|<0.001
71003361|NCT04315298|141514466|SUPERIORITY|||||||0.9117|||||||Chi-squared|||Disease Severity: MSOD||||0.9117
71003362|NCT04315298|141514466|SUPERIORITY|||||||0.7584|||||||Chi-squared|||Disease Severity: MSOD||||0.7584
71003363|NCT04315298|141514470|SUPERIORITY||Hazard Ratio (HR)|0.32||||0.0385|TWO_SIDED|95.0|0.11|0.94||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||0.94|0.11|0.0385
71003364|NCT04315298|141514470|SUPERIORITY||Hazard Ratio (HR)|0.38||||0.0782|TWO_SIDED|95.0|0.14|1.05||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.05|0.14|0.0782
71003365|NCT04315298|141514470|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.2436|TWO_SIDED|95.0|0.7|2.14||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||2.14|0.70|0.2436
71003366|NCT04315298|141514470|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.3223|TWO_SIDED|95.0|0.46|1.51||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||1.51|0.46|0.3223
71003367|NCT04315298|141514470|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.467|TWO_SIDED|95.0|0.36|1.52||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||1.52|0.36|0.4670
71003368|NCT04315298|141514470|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.3728|TWO_SIDED|95.0|0.35|1.47||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||1.47|0.35|0.3728
71003369|NCT04315298|141514476|SUPERIORITY||Risk Difference (RD)|2.7||||0.5851|TWO_SIDED|95.0|-7.0|12.4||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||12.4|-7.0|0.5851
71003370|NCT04315298|141514476|SUPERIORITY||Risk Difference (RD)|-2.6||||0.5767|TWO_SIDED|95.0|-11.7|6.5||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||6.5|-11.7|0.5767
71003371|NCT04315298|141514477|SUPERIORITY||Risk Difference (RD)|5.2||||0.4777|TWO_SIDED|95.0|-9.4|18.6||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||18.6|-9.4|0.4777
71003372|NCT04315298|141514477|SUPERIORITY||Risk Difference (RD)|5.7||||0.4202|TWO_SIDED|95.0|-8.4|18.2||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||18.2|-8.4|0.4202
71003373|NCT04315298|141514478|SUPERIORITY||Risk Difference (RD)|0.2||||0.9696|TWO_SIDED|95.0|-9.5|9.9||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||9.9|-9.5|0.9696
71003374|NCT04315298|141514478|SUPERIORITY||Risk Difference (RD)|-4.7||||0.3152|TWO_SIDED|95.0|-13.8|4.4||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||4.4|-13.8|0.3152
71003375|NCT04315298|141514479|SUPERIORITY||Risk Difference (RD)|-7.7||||0.3217|TWO_SIDED|95.0|-22.8|7.2||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 29||7.2|-22.8|0.3217
71003376|NCT04315298|141514479|SUPERIORITY||Risk Difference (RD)|-5.5||||0.463|TWO_SIDED|95.0|-20.2|8.7||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 29||8.7|-20.2|0.4630
71003377|NCT04315298|141514479|SUPERIORITY||Risk Difference (RD)|-13.3||||0.0971|TWO_SIDED|95.0|-28.2|2.3||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 60||2.3|-28.2|0.0971
71003378|NCT04315298|141514479|SUPERIORITY||Risk Difference (RD)|-11.9||||0.1193|TWO_SIDED|95.0|-26.4|2.9||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 60||2.9|-26.4|0.1193
71003379|NCT04315298|141514480|SUPERIORITY||Risk Difference (RD)|-0.6||||0.8844|TWO_SIDED|95.0|-9.3|7.7||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 29||7.7|-9.3|0.8844
71003380|NCT04315298|141514480|SUPERIORITY||Risk Difference (RD)|5.2||||0.2247|TWO_SIDED|95.0|-3.3|13.0||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 29||13.0|-3.3|0.2247
71003381|NCT04315298|141514480|SUPERIORITY||Risk Difference (RD)|-13.3||||0.2102|TWO_SIDED|95.0|-28.2|2.3||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 60||2.3|-28.2|0.2102
71003382|NCT04315298|141514480|SUPERIORITY||Risk Difference (RD)|-11.9||||0.8292|TWO_SIDED|95.0|-26.4|2.9||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 60||2.9|-26.4|0.8292
71003383|NCT04315298|141514481|SUPERIORITY||Risk Difference (RD)|9.8||||0.2203|TWO_SIDED|95.0|-6.0|24.3||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||24.3|-6.0|0.2203
71003384|NCT04315298|141514481|SUPERIORITY||Risk Difference (RD)|8.8||||0.2483|TWO_SIDED|95.0|-6.1|22.6||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||22.6|-6.1|0.2483
71043327|NCT00739973|141595806|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.98|STANDARD_ERROR_OF_MEAN|0.92|<|0.001|TWO_SIDED|95.0|-5.78|-2.18|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-2.18|-5.78|<0.001
71043328|NCT00739973|141595807|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-9.64|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-11.41|-7.87|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-7.87|-11.41|<0.001
71043329|NCT00739973|141595808|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-6.26|STANDARD_ERROR_OF_MEAN|0.89|<|0.001|TWO_SIDED|95.0|-8.0|-4.51|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-4.51|-8.00|<0.001
71003385|NCT04315298|141514482|SUPERIORITY||Risk Difference (RD)|4.1||||0.602|TWO_SIDED|95.0|-11.2|18.5||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||18.5|-11.2|0.6020
71003386|NCT04315298|141514482|SUPERIORITY||Risk Difference (RD)|5.9||||0.4342|TWO_SIDED|95.0|-8.9|19.5||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||19.5|-8.9|0.4342
71003387|NCT04315298|141514483|SUPERIORITY||Risk Difference (RD)|5.2||||0.2896|TWO_SIDED|95.0|-4.3|14.7||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||14.7|-4.3|0.2896
71003388|NCT04315298|141514483|SUPERIORITY||Risk Difference (RD)|-2.9||||0.5355|TWO_SIDED|95.0|-11.8|6.2||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||6.2|-11.8|0.5355
71003389|NCT04315298|141514484|SUPERIORITY||Risk Difference (RD)|0.5||||0.921|TWO_SIDED|95.0|-9.2|10.2||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||10.2|-9.2|0.9210
71003390|NCT04315298|141514484|SUPERIORITY||Risk Difference (RD)|-4.7||||0.3174|TWO_SIDED|95.0|-13.8|4.5||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||4.5|-13.8|0.3174
71003391|NCT04315298|141514485|SUPERIORITY||Hazard Ratio (HR)|1.62||||0.0705|TWO_SIDED|95.0|0.98|2.66||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||2.66|0.98|0.0705
71003392|NCT04315298|141514485|SUPERIORITY||Hazard Ratio (HR)|1.5||||0.18|TWO_SIDED|95.0|0.92|2.43||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||2.43|0.92|0.1800
71003393|NCT04315298|141514486|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.1831|TWO_SIDED|95.0|0.91|1.52||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.52|0.91|0.1831
71003394|NCT04315298|141514486|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.877|TWO_SIDED|95.0|0.82|1.34||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.34|0.82|0.8770
71003395|NCT04315298|141514487|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.7103|TWO_SIDED|95.0|0.35|2.06||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||2.06|0.35|0.7103
71101100|NCT04526158|141710289|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.079|TWO_SIDED|95.0|0.0|0.8|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS Anxiety, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.8|0.0|0.079
71101101|NCT04526158|141710289|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.296|TWO_SIDED|95.0|-0.6|0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS Anxiety, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.2|-0.6|0.296
71101102|NCT04526158|141710289|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.005|TWO_SIDED|95.0|-1.0|-0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS Anxiety, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-1.0|0.005
71101103|NCT04526158|141710290|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.464|TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS fatigue, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.7|-0.3|0.464
71101104|NCT04526158|141710290|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.019|TWO_SIDED|95.0|-1.1|-0.1|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS fatigue, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.1|-1.1|0.019
71003396|NCT04315298|141514488|SUPERIORITY||Hazard Ratio (HR)|1.47||||0.1512|TWO_SIDED|95.0|0.89|2.43||P-value from stratified log-rank test|Log Rank|||||2.43|0.89|0.1512
71003397|NCT04315298|141514488|SUPERIORITY||Hazard Ratio (HR)|1.38||||0.2952|TWO_SIDED|95.0|0.85|2.24||P-value from stratified log-rank test|Log Rank|||||2.24|0.85|0.2952
71101105|NCT04526158|141710290|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.002|TWO_SIDED|95.0|-1.3|-0.3|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS fatigue, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.3|-1.3|0.002
70924641|NCT04321031|141342038|SUPERIORITY||Risk Difference (RD)|0.18|||||TWO_SIDED|90.0|-0.03|0.35||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.35|-0.03|
71003398|NCT04315298|141514489|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.2297|TWO_SIDED|95.0|0.89|1.5||P-value from stratified log-rank test|Log Rank|||||1.50|0.89|0.2297
71003399|NCT04315298|141514489|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.8651|TWO_SIDED|95.0|0.79|1.3||P-value from stratified log-rank test|Log Rank|||||1.30|0.79|0.8651
71003400|NCT04315298|141514490|SUPERIORITY||Risk Difference (RD)|-1.0||||0.8864|TWO_SIDED|95.0|-15.2|12.1||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||12.1|-15.2|0.8864
71003401|NCT04315298|141514490|SUPERIORITY||Risk Difference (RD)|-2.1||||0.75|TWO_SIDED|95.0|-15.8|10.1||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||10.1|-15.8|0.7500
71101106|NCT04526158|141710291|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.889|TWO_SIDED|95.0|-0.5|0.4|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS sleep disturbance, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.4|-0.5|0.889
70924642|NCT04321031|141342039|SUPERIORITY||Least Square (LS) Mean|-25.98|||||TWO_SIDED|90.0|-58.42|-2.57||||||||-2.57|-58.42|
70924643|NCT04321031|141342039|SUPERIORITY||LS Mean|-35.41|||||TWO_SIDED|90.0|-69.41|-5.42||||||||-5.42|-69.41|
71003402|NCT04315298|141514491|SUPERIORITY||Risk Difference (RD)|-1.5||||0.6858|TWO_SIDED|95.0|-9.1|5.6||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||5.6|-9.1|0.6858
71003403|NCT04315298|141514491|SUPERIORITY||Risk Difference (RD)|0.4||||0.9173|TWO_SIDED|95.0|-7.0|7.0||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||7.0|-7.0|0.9173
71003404|NCT04315298|141514492|SUPERIORITY||Risk Difference (RD)|4.5||||0.5239|TWO_SIDED|95.0|-9.7|17.3||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||17.3|-9.7|0.5239
71003405|NCT04315298|141514492|SUPERIORITY||Risk Difference (RD)|3.7||||0.5809|TWO_SIDED|95.0|-10.0|15.6||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||15.6|-10.0|0.5809
71003406|NCT04315298|141514493|SUPERIORITY||Risk Difference (RD)|0.4||||0.9343|TWO_SIDED|95.0|-9.3|10.1||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||10.1|-9.3|0.9343
71003407|NCT04315298|141514493|SUPERIORITY||Risk Difference (RD)|-5.0||||0.2822|TWO_SIDED|95.0|-14.1|4.1||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||4.1|-14.1|0.2822
71003408|NCT04315298|141514494|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.4519|TWO_SIDED|95.0|0.75|2.18||P-value from stratified log-rank test|Log Rank|||||2.18|0.75|0.4519
71003409|NCT04315298|141514494|SUPERIORITY||Hazard Ratio (HR)|1.35||||0.2818|TWO_SIDED|95.0|0.81|2.24||P-value from stratified log-rank test|Log Rank|||||2.24|0.81|0.2818
71003410|NCT04315298|141514495|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.4674|TWO_SIDED|95.0|0.84|1.43||P-value from stratified log-rank test|Log Rank|||||1.43|0.84|0.4674
71003411|NCT04315298|141514495|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.8503|TWO_SIDED|95.0|0.77|1.28||P-value from stratified log-rank test.|Log Rank|||||1.28|0.77|0.8503
71003412|NCT04315298|141514496|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.6156|TWO_SIDED|95.0|0.31|2.02||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||2.02|0.31|0.6156
71003413|NCT04315298|141514497|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0843|TWO_SIDED|95.0|0.41|1.03||P-value from stratified log-rank test|Log Rank|||||1.03|0.41|0.0843
71003414|NCT04315298|141514497|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.1576|TWO_SIDED|95.0|0.44|1.07||P-value from stratified log-rank test|Log Rank|||||1.07|0.44|0.1576
71003415|NCT04315298|141514498|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.198|TWO_SIDED|95.0|0.57|1.14||P-value from stratified log-rank test|Log Rank|||||1.14|0.57|0.1980
70924644|NCT04321031|141342039|SUPERIORITY||LS Mean|-40.54|||||TWO_SIDED|90.0|-75.55|-7.32||||||||-7.32|-75.55|
71003416|NCT04315298|141514498|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.7973|TWO_SIDED|95.0|0.73|1.36||P-value from stratified log-rank test.|Log Rank|||||1.36|0.73|0.7973
71043330|NCT00739973|141595809|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.63|STANDARD_ERROR_OF_MEAN|0.92||0.004|TWO_SIDED|95.0|-4.42|-0.83|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-0.83|-4.42|0.004
71043331|NCT00739973|141595810|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-11.1|STANDARD_ERROR_OF_MEAN|0.89|<|0.001|TWO_SIDED|95.0|-12.85|-9.35|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-9.35|-12.85|<0.001
71043332|NCT00739973|141595811|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.83|STANDARD_ERROR_OF_MEAN|1.48||0.056|TWO_SIDED|95.0|-5.73|-0.07|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-0.07|-5.73|0.056
71043333|NCT00739973|141595812|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-17.08|STANDARD_ERROR_OF_MEAN|1.44|<|0.001||95.0|-19.91|-14.3|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-14.3|-19.91|<0.001
71043334|NCT00739973|141595813|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-6.45|STANDARD_ERROR_OF_MEAN|1.45|<|0.001|TWO_SIDED|95.0|-9.29|-3.62|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-3.62|-9.29|<0.001
71043335|NCT00739973|141595814|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.48|<|0.001|TWO_SIDED|95.0|-8.9|-3.11|||ANCOVA|A two-way analysis of covariance model with treatment and region asntwo factors, and the baseline as a covariate.||||-3.11|-8.90|<0.001
71043336|NCT00739973|141595815|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-15.03|STANDARD_ERROR_OF_MEAN|1.45|<|0.001|TWO_SIDED|95.0|-17.88|-12.2|||ANCOVA|||||-12.2|-17.88|<0.001
71043337|NCT00739973|141595816|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-7.82|STANDARD_ERROR_OF_MEAN|1.43|<|0.001|TWO_SIDED|95.0|-10.63|-5.02|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-5.02|-10.63|<0.001
71043338|NCT00739973|141595817|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.16|STANDARD_ERROR_OF_MEAN|1.47||0.143|TWO_SIDED|95.0|-5.04|0.73|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||0.73|-5.04|0.143
71043339|NCT00739973|141595818|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-16.4|STANDARD_ERROR_OF_MEAN|1.43|<|0.001|TWO_SIDED|95.0|-19.21|-13.6|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-13.6|-19.21|<0.001
71043340|NCT01181531|141595824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.0|STANDARD_ERROR_OF_MEAN|5.3||0.346|TWO_SIDED|95.0|-15.4|5.4||Unadjusted. Model contains baseline stratification factor for type of Vitamin D administered at the site|Mixed Models Analysis||Cinacalcet - Vitamin D|Null hypothesis: no difference in % change from baseline in PTH comparing the two treatment arms.||5.4|-15.4|0.346
71043341|NCT01181531|141595825|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.11|TWO_SIDED|95.0|0.92|2.29||Stratified by type of Vitamin D at site|Cochran-Mantel-Haenszel||OR is Cinacalcet: Vitamin D|||2.29|0.92|0.110
71043342|NCT01181531|141595826|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.346|TWO_SIDED|95.0|0.74|2.39||stratified by type of Vitamin D at site|Cochran-Mantel-Haenszel||OR is Cinacalcet: Vitamin D|||2.39|0.74|0.346
70924645|NCT04321031|141342039|SUPERIORITY||LS Mean|-44.74|||||TWO_SIDED|90.0|-81.72|-8.42||||||||-8.42|-81.72|
71003417|NCT04315298|141514499|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.5023|TWO_SIDED|95.0|0.13|2.75||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||2.75|0.13|0.5023
71003418|NCT04315298|141514500|SUPERIORITY||Risk Difference (RD)|0.3|STANDARD_ERROR_OF_MEAN|0.26||0.2804|TWO_SIDED|95.0|-0.2|0.8||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 8||0.8|-0.2|0.2804
71003419|NCT04315298|141514500|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.5023|TWO_SIDED|95.0|-0.5|0.3||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 8||0.3|-0.5|0.5023
71003420|NCT04315298|141514500|SUPERIORITY||Risk Difference (RD)|0.6|STANDARD_ERROR_OF_MEAN|0.68||0.3821|TWO_SIDED|95.0|-0.7|1.9||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 15||1.9|-0.7|0.3821
71003421|NCT04315298|141514500|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|0.59||0.9737|TWO_SIDED|95.0|-1.2|1.1||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 15||1.1|-1.2|0.9737
71003422|NCT04315298|141514500|SUPERIORITY||Risk Difference (RD)|1.2|STANDARD_ERROR_OF_MEAN|1.15||0.3179|TWO_SIDED|95.0|-1.1|3.4||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 22||3.4|-1.1|0.3179
71003423|NCT04315298|141514500|SUPERIORITY||Risk Difference (RD)|0.5|STANDARD_ERROR_OF_MEAN|1.03||0.6302|TWO_SIDED|95.0|-1.5|2.5||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 22||2.5|-1.5|0.6302
71003424|NCT04315298|141514500|SUPERIORITY||Risk Difference (RD)|1.8|STANDARD_ERROR_OF_MEAN|1.64||0.2862|TWO_SIDED|95.0|-1.5|5.0||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 29||5.0|-1.5|0.2862
70924646|NCT04321031|141342040|SUPERIORITY||LS Mean|-41.82|||||TWO_SIDED|90.0|-62.57|-9.57||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-9.57|-62.57|
71003425|NCT04315298|141514500|SUPERIORITY||Risk Difference (RD)|1.1|STANDARD_ERROR_OF_MEAN|1.49||0.4509|TWO_SIDED|95.0|-1.8|4.1||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 29||4.1|-1.8|0.4509
71003426|NCT04315298|141514501|SUPERIORITY||Risk Difference (RD)|-0.2|STANDARD_ERROR_OF_MEAN|0.33||0.564|TWO_SIDED|95.0|-0.8|0.5||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 8||0.5|-0.8|0.5640
71003427|NCT04315298|141514501|SUPERIORITY||Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|0.31||0.1602|TWO_SIDED|95.0|-1.0|0.2||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 8||0.2|-1.0|0.1602
71003428|NCT04315298|141514501|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.64||0.9144|TWO_SIDED|95.0|-1.3|1.2||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 15||1.2|-1.3|0.9144
71003429|NCT04315298|141514501|SUPERIORITY||Risk Difference (RD)|-0.9|STANDARD_ERROR_OF_MEAN|0.61||0.145|TWO_SIDED|95.0|-2.1|0.3||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 15||0.3|-2.1|0.1450
71003430|NCT04315298|141514501|SUPERIORITY||Risk Difference (RD)|0.2|STANDARD_ERROR_OF_MEAN|0.95||0.8378|TWO_SIDED|95.0|-1.7|2.1||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 22||2.1|-1.7|0.8378
71003431|NCT04315298|141514501|SUPERIORITY||Risk Difference (RD)|-1.2|STANDARD_ERROR_OF_MEAN|0.89||0.1988|TWO_SIDED|95.0|-2.9|0.6||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 22||0.6|-2.9|0.1988
71003432|NCT04315298|141514501|SUPERIORITY||Risk Difference (RD)|0.2|STANDARD_ERROR_OF_MEAN|1.26||0.8556|TWO_SIDED|95.0|-2.2|2.7||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 29||2.7|-2.2|0.8556
71003433|NCT04315298|141514501|SUPERIORITY||Risk Difference (RD)|-1.3|STANDARD_ERROR_OF_MEAN|1.19||0.263|TWO_SIDED|95.0|-3.7|1.0||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 29||1.0|-3.7|0.2630
71003434|NCT04315298|141514502|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.18||0.3662|TWO_SIDED|95.0|-0.2|0.5||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 8||0.5|-0.2|0.3662
71043343|NCT00987831|141595827|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|30.0||||0.2738|TWO_SIDED|95.0|5.0|95.0||Definition of Moderate Disease was \</= 3 BILAG B (moderate) organ scores, no A (severe) scores and SLEDAI \</=10. Severe disease was \> 3 BILAG B or \>/= BILAG A or SLEDAI \> 10 or meets definition for severe flare on the SELENA SLEDAI Flare Index|Log Rank|||||95|5|0.2738
71043344|NCT00810602|141595835|SUPERIORITY_OR_OTHER||Percent Cumulative Incidence of GVHD|22.0|||||TWO_SIDED|95.0|13.0|36.0||||||Hypothesis: The addition of vorinostat will reduce the incidence of grade 2-4 acute graft versus host disease (GVHD) to 25% or lower by day 100.||36|13|
71043345|NCT00810602|141595837|SUPERIORITY_OR_OTHER||Percent Cumulative Incidence of GVHD|16.0|||||TWO_SIDED|95.0|8.0|30.0||||||||30|8|
71003435|NCT04315298|141514502|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.16||0.082|TWO_SIDED|95.0|0.0|0.6||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 8||0.6|0.0|0.0820
71043346|NCT02792218|141595839|SUPERIORITY||rate ratio|0.495|||<|0.001|TWO_SIDED|95.0|0.375|0.655|||negative binomial regression model|||Obtained from fitting a negative binomial regression model with log-link to the number of relapses, adjusted for treatment and region as factors, number of relapses in previous year, baseline EDSS, baseline number of Gd-enhancing lesions and the patient's age at baseline as covariates. The natural log of the time-in-study was used as offset to annualize the relapse rate.||0.655|0.375|<0.001
71003436|NCT04315298|141514502|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.37||0.6984|TWO_SIDED|95.0|-0.9|0.6||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 15||0.6|-0.9|0.6984
71043347|NCT02792218|141595840|SUPERIORITY||Hazard Ratio (HR)|0.657||||0.003|TWO_SIDED|95.0|0.5|0.863|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2302 to address this endpoint.||0.863|0.500|0.003
71043348|NCT02792218|141595841|SUPERIORITY||Hazard Ratio (HR)|0.652||||0.029|TWO_SIDED|95.0|0.445|0.956|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2302 to address this endpoint.||0.956|0.445|0.029
71043349|NCT02792218|141595842|SUPERIORITY||Hazard Ratio (HR)|0.676||||0.012|TWO_SIDED|95.0|0.498|0.917|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2302 to address this endpoint.||0.917|0.498|0.012
71003437|NCT04315298|141514502|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.32||0.9833|TWO_SIDED|95.0|-0.6|0.6||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 15||0.6|-0.6|0.9833
71003438|NCT04315298|141514502|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|0.56||0.1436|TWO_SIDED|95.0|-0.3|2.0||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 22||2.0|-0.3|0.1436
71003439|NCT04315298|141514502|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.49||0.419|TWO_SIDED|95.0|-0.6|1.4||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 22||1.4|-0.6|0.4190
71003440|NCT04315298|141514502|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.47||0.652|TWO_SIDED|95.0|-0.7|1.2||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 29||1.2|-0.7|0.6520
71003441|NCT04315298|141514502|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.801|TWO_SIDED|95.0|-1.1|0.9||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 29||0.9|-1.1|0.8010
71003442|NCT04315298|141514503|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.16||0.3724|TWO_SIDED|95.0|-0.4|0.2||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 8||0.2|-0.4|0.3724
71003443|NCT04315298|141514503|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.13||0.7034|TWO_SIDED|95.0|-0.2|0.3||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 8||0.3|-0.2|0.7034
71003444|NCT04315298|141514503|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.28||0.5841|TWO_SIDED|95.0|-0.4|0.7||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 15||0.7|-0.4|0.5841
71003445|NCT04315298|141514503|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.27||0.6648|TWO_SIDED|95.0|-0.4|0.6||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 15||0.6|-0.4|0.6648
71003446|NCT04315298|141514503|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.36||0.4624|TWO_SIDED|95.0|-0.4|1.0||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 22||1.0|-0.4|0.4624
71003447|NCT04315298|141514503|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.32||0.2546|TWO_SIDED|95.0|-0.3|1.0||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 22||1.0|-0.3|0.2546
71003448|NCT04315298|141514503|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.38||0.5312|TWO_SIDED|95.0|-1.0|0.5||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 29||0.5|-1.0|0.5312
71003449|NCT04315298|141514503|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.35||0.3039|TWO_SIDED|95.0|-1.1|0.3||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 29||0.3|-1.1|0.3039
71003450|NCT01183104|141514532|NON_INFERIORITY_OR_EQUIVALENCE|The pre-defined non-inferiority margin was 0.3%.|LS mean difference|0.11||||0.087|TWO_SIDED|95.0|-0.02|0.24|||ANCOVA|||||0.24|-0.02|0.087
71003451|NCT01183104|141514533|SUPERIORITY_OR_OTHER|||||||0.002|||||||Fisher Exact|||||||0.002
71003452|NCT01183104|141514534|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
71043350|NCT02792218|141595843|SUPERIORITY||Hazard Ratio (HR)|0.607||||0.022|TWO_SIDED|95.0|0.396|0.93|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2302 to address this endpoint.||0.930|0.396|0.022
71043351|NCT02792218|141595844|SUPERIORITY||Hazard Ratio (HR)|1.355||||0.092|TWO_SIDED|95.0|0.952|1.952|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2302 to address this endpoint.||1.952|0.952|0.092
71003453|NCT01183104|141514535|SUPERIORITY_OR_OTHER|||||||0.03|||||||ANCOVA|||||||0.030
71003454|NCT01183104|141514536|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
71003455|NCT01183104|141514537|SUPERIORITY_OR_OTHER|||||||0.043|||||||ANCOVA|||||||0.043
71003456|NCT03267511|141514538|OTHER||Difference of Least Mean Square|0.06|STANDARD_ERROR_OF_MEAN|0.128||0.6499|TWO_SIDED|95.0|-0.19|0.31|||ANCOVA|From ANCOVA with treatment as fixed effect and baseline overall MLSI score as a covariate.|||"The reason for entering same analysis for primary and secondary is because statistical analysis was not done separately for primary outcome measure.~The decision was clinical decision at the time of protocol design.There was no comparisons for the primary objective as the main objective was to look at the rank order of the treatments in level of stain reduction after 8 weeks of treatment. This was achieved via the adjusted means and confidence intervals for the means along with plots of MLSI over time. The hypothesis was that the test products would reduce stain to a greater extent than the reference products. Two comparisons of interest were done under secondary and exploratory objectives."|0.31|-0.19|0.6499
71003457|NCT03267511|141514538|OTHER||Difference of Least Square mean|-0.07|STANDARD_ERROR_OF_MEAN|0.128||0.568|TWO_SIDED|95.0|-0.33|0.18|||ANCOVA|From ANCOVA with treatment as fixed effect and baseline overall MLSI score as a covariate.|-0.33 to 0.18|||0.18|-0.33|0.5680
71003458|NCT03267511|141514539|OTHER||Difference of Least Square mean|0.06|STANDARD_ERROR_OF_MEAN|0.128||0.6499|TWO_SIDED|95.0|-0.19|0.31|||ANCOVA|From ANCOVA with treatment as fixed effect and baseline overall MLSI score as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.31|-0.19|0.6499
71003459|NCT03267511|141514540|OTHER||Difference of Least Square mean|-0.07|STANDARD_ERROR_OF_MEAN|0.128||0.568|TWO_SIDED|95.0|-0.33|0.18|||ANCOVA|From ANCOVA with treatment as fixed effect and baseline overall MLSI score as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.18|-0.33|0.5680
71003460|NCT03887052|141514563|NON_INFERIORITY|The primary endpoint was performed as a one-sided test with a 0.025 significance level of the null hypothesis (H0) that the WCD false positive shock alarm rate per patient-day for the study device was equal to or greater than the comparator rate (0.29). A random-effects Poisson regression model was fit with the number of false-positive shock alarms for each patient as the outcome, the logarithm of days of wear as an offset, and random site effect.|||||<|0.001||||||"Hypotheses:~H0: p1 ≥ 0.29 H1: p1 \< 0.29~where p1 = A-WCD False Positive Alarm Rate"|One-sided non-inferiority|Poisson Regression Analysis||The analysis was based on the cohort of 130 patients with three false-positive shock alarms occurring over a total of 3501 patient-days (500 weeks), or 0.0060 false-positive shock alarms per patient-week. The Poisson distribution was used to model the results and calculate the false-positive shock alarm rate.||||<0.001
71003461|NCT00628134|141514568|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon matched-pairs signed-ranks test was used for comparisons||||0.07
71003462|NCT00628134|141514569|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon matched-pairs signed-ranks test was used for comparisons||||0.29
71003463|NCT03687827|141514570|SUPERIORITY|Superiority is confirmed if non-inferiority is confirmed and the lower limit of the two-sided 95% confidence interval is entirely above zero.|Estimated treatment difference|1.43||||0.0321|TWO_SIDED|95.0|0.12|2.74|||t-test, 2 sided|||||2.74|0.12|0.0321
71003464|NCT03687827|141514570|NON_INFERIORITY|A non-inferiority margin of -0.83% has been applied, corresponding to 0.2 hours/24 hours|Estimated treatment difference|1.43|||||TWO_SIDED|95.0|0.12|2.74||||||||2.74|0.12|
71003465|NCT02128958|141514582|OTHER|||||||0.536|||||||Log Rank|||The between-treatment comparison (CF102 vs Placebo) of Overall Survival will be performed using the log rank test as the primary analysis.||||0.536
71003466|NCT02128958|141514583|OTHER|||||||0.371|||||||Log Rank|||The between-treatment comparison (CF102 vs Placebo) of Time to Progression will be performed using the log rank test as the primary analysis.||||.371
71003467|NCT02128958|141514584|OTHER|||||||0.521|||||||Log Rank|||The between-treatment comparison (CF102 vs Placebo) will be performed on Time to Progression Free Survival using the logrank test.||||0.521
71003468|NCT02128958|141514587|OTHER|||||||0.988|||||||ANCOVA|||Between-treatment comparisons of ALT will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.988
71101107|NCT04526158|141710291|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.004|TWO_SIDED|95.0|-1.1|-0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS sleep disturbance, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-1.1|0.004
71101108|NCT04526158|141710291|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.006|TWO_SIDED|95.0|-1.1|-0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS sleep disturbance, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-1.1|0.006
71101109|NCT04526158|141710292|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.76|TWO_SIDED|95.0|-0.4|0.5|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS social roles and activities, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.5|-0.4|0.76
71101110|NCT04526158|141710292|SUPERIORITY||Mean Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|95.0|0.6|1.4|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS social roles and activities, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||1.4|0.6|<0.001
71101111|NCT04526158|141710292|SUPERIORITY||Mean Difference (Final Values)|0.9|||<|0.001|TWO_SIDED|95.0|0.5|1.3|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS social roles and activities, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||1.3|0.5|<0.001
71101112|NCT04526158|141710293|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.89|TWO_SIDED|95.0|-0.7|0.6|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PHQ8, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.6|-0.7|0.89
71101113|NCT04526158|141710293|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.003|TWO_SIDED|95.0|-1.5|-0.3|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PHQ8, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.3|-1.5|0.003
71101114|NCT04526158|141710293|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.007|TWO_SIDED|95.0|-1.5|-0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PHQ8, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-1.5|0.007
71101115|NCT04526158|141710294|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.886|TWO_SIDED|95.0|-1.6|1.9|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PCL5, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||1.9|-1.6|0.886
71101116|NCT04526158|141710294|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.017|TWO_SIDED|95.0|-3.7|-0.4|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PCL5, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.4|-3.7|0.017
71003469|NCT02128958|141514587|OTHER|||||||0.989|||||||ANCOVA|||Between-treatment comparisons of AST will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.989
71003470|NCT02128958|141514587|OTHER|||||||0.717|||||||ANCOVA|||Between-treatment comparisons of Albumin will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.717
71003471|NCT02128958|141514587|OTHER|||||||0.891|||||||ANCOVA|||Between-treatment comparisons of Bilirubin (direct) will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.891
71003472|NCT02128958|141514587|OTHER|||||||0.275|||||||ANCOVA|||Between-treatment comparisons of Bilirubin (Total) will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.275
71003473|NCT02128958|141514587|OTHER|||||||0.549|||||||ANCOVA|||Between-treatment comparisons of PT will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.549
71003474|NCT02128958|141514587|OTHER|||||||0.479|||||||ANCOVA|||Between-treatment comparisons of INR will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.479
71003475|NCT00981292|141514595|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||A Bonferroni adjustment was made for multiplicity.|ANOVA|||This data was analysed by two-way repeated measures ANOVA (task \[epoch\] x treatment). In the case of those analyses that showed a significant main effect of treatment or a task/epoch x treatment interaction, planned comparisons of data from each task or epoch were then made between placebo and each of the EGCG treatment groups using t tests calculated with the Mean Squares Error from the ANOVA.||||<0.05
71003476|NCT00981292|141514596|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||Task performance data were analysed by within subjects ANCOVA (treatment) with pre-treatment performance included as a co-variate for each individual task/measure.||||>0.05
71003477|NCT00981292|141514597|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Mood data was analysed via student t-test.||||>0.05
71101117|NCT04526158|141710294|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.013|TWO_SIDED|95.0|-3.9|-0.5|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PCL5, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.5|-3.9|0.013
71003478|NCT00262639|141514644|SUPERIORITY|||||||0.03|||||||Regression, Logistic|||||||0.03
71003479|NCT00262639|141514645|SUPERIORITY|||||||0.0006||||||This p value is for the interaction of AW status by medication group.|ANOVA|||The analysis was an ANOVA interaction analysis with alcohol withdrawal (AW) group (Low vs. High) by medication group (active versus placebo medication) across the 6 weeks of the medication trial.||||0.0006
71003480|NCT03342404|141514655|SUPERIORITY||Difference in proportions|77.1|||||TWO_SIDED|95.0|63.4|87.0|||||The difference in proportions (luspatercept - placebo) and 95% CI were estimated from the exact unconditional test|||87.0|63.4|
71003481|NCT03342404|141514655|SUPERIORITY||Risk Difference (RD)|77.1|||||TWO_SIDED|95.0|68.7|85.5|||||The common risk difference (luspatercept - placebo) and 95% CI were estimated from the CMH test stratified by baseline Hb category and baseline NTDT-PRO T/W domain score category|||85.5|68.7|
71003482|NCT03342404|141514656|SUPERIORITY||Mean Difference (Net)|-0.48||||0.0924|TWO_SIDED|95.0|-1.03|0.08|||ANCOVA|||||0.08|-1.03|0.0924
71003483|NCT03342404|141514657|SUPERIORITY||Mean Difference (Net)|1.42|||<|0.0001|TWO_SIDED|95.0|1.16|1.67|||ANCOVA|||||1.67|1.16|< 0.0001
71003484|NCT03342404|141514658|SUPERIORITY||Mean Difference (Net)|68.8|||<|0.0001|TWO_SIDED|95.0|54.3|80.4|||Cochran-Mantel-Haenszel|||||80.4|54.3|< 0.0001
71003485|NCT03342404|141514659|SUPERIORITY||Mean Difference (Net)|1.39||||0.2641|TWO_SIDED|95.0|-1.06|3.83|||ANCOVA|||||3.83|-1.06|0.2641
71003486|NCT03342404|141514660|SUPERIORITY||Mean Difference (Net)|-0.49||||0.0721|TWO_SIDED|95.0|-1.02|0.04|||ANCOVA|||||0.04|-1.02|0.0721
71003487|NCT03342404|141514661|SUPERIORITY||Mean Difference (Net)|1.49|||<|0.0001|TWO_SIDED|95.0|1.2|1.79|||ANCOVA|||||1.79|1.20|< 0.0001
71003488|NCT03342404|141514662|SUPERIORITY||Mean Difference (Net)|2.19||||0.0959|TWO_SIDED|95.0|-0.39|4.78|||ANCOVA|||||4.78|-0.39|0.0959
71043352|NCT02792218|141595845|SUPERIORITY||Hazard Ratio (HR)|1.186||||0.516|TWO_SIDED|95.0|0.709|1.983|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2302 to address this endpoint.||1.983|0.709|0.516
71003489|NCT03342404|141514663|SUPERIORITY||Mean Difference (Net)|-0.79||||0.051|TWO_SIDED|95.0|-1.58|0.0|||ANCOVA|||||0.00|-1.58|0.0510
71003490|NCT03342404|141514664|SUPERIORITY||Mean Difference (Net)|-1.07||||0.0047|TWO_SIDED|95.0|-1.8|-0.33|||ANCOVA|||||-0.33|-1.80|0.0047
71003491|NCT03342404|141514665|SUPERIORITY||Odds Ratio (OR)|1.8||||0.1359|TWO_SIDED|95.0|0.8|4.0|||Cochran-Mantel-Haenszel|||||4.0|0.8|0.1359
71003492|NCT03342404|141514666|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0657|TWO_SIDED|95.0|0.9|5.4|||Cochran-Mantel-Haenszel|||||5.4|0.9|0.0657
71003493|NCT03342404|141514667|SUPERIORITY||Mean Difference (Net)|1.39||||0.0847|TWO_SIDED|95.0|-0.19|2.96|||Mixed Models Analysis|||Mean change from baseline in SF-36 PCS to Week 24||2.96|-0.19|0.0847
71003494|NCT03342404|141514667|SUPERIORITY||Mean Difference (Net)|1.75||||0.0712|TWO_SIDED|95.0|-0.15|3.65|||Mixed Models Analysis|||Mean change from baseline in SF-36 PCS to Week 48||3.65|-0.15|0.0712
71003495|NCT03342404|141514667|SUPERIORITY||Mean Difference (Net)|1.54||||0.1633|TWO_SIDED|95.0|-0.63|3.72|||Mixed Models Analysis|||Mean change from baseline in SF-36 MCS to Week 24||3.72|-0.63|0.1633
71003496|NCT03342404|141514667|SUPERIORITY||Mean Difference (Net)|2.7||||0.0469|TWO_SIDED|95.0|0.04|5.36|||Mixed Models Analysis|||Mean change from baseline in SF-36 MCS to Week 48||5.36|0.04|0.0469
71003497|NCT03342404|141514668|SUPERIORITY||Mean Difference (Net)|-4.2||||0.4787|TWO_SIDED|95.0|-21.4|13.0|||Cochran-Mantel-Haenszel|||Percentage of participants with improvement of iron overload (LIC/ICT responders) at Week 24||13.0|-21.4|0.4787
71003498|NCT03342404|141514668|SUPERIORITY||Mean Difference (Net)|-14.6||||0.0827|TWO_SIDED|95.0|-31.5|2.4|||Cochran-Mantel-Haenszel|||Percentage of participants with improvement of iron overload (LIC/ICT responders) at Week 48||2.4|-31.5|0.0827
71003499|NCT03342404|141514669|SUPERIORITY||Mean Difference (Net)|27.14||||0.5949|TWO_SIDED|95.0|-46.77|101.06|||ANCOVA|||Mean change from baseline in serum ferritin at Week 24||101.06|-46.77|0.5949
71003500|NCT03342404|141514669|SUPERIORITY||Mean Difference (Net)|13.46||||0.3454|TWO_SIDED|95.0|-61.01|87.93|||ANCOVA|||Mean change from baseline in serum ferritin at Week 48||87.93|-61.01|0.3454
71003501|NCT03342404|141514670|SUPERIORITY||Mean Difference (Net)|-0.09||||0.6628|TWO_SIDED|95.0|-0.47|0.3|||ANCOVA|||Mean change from baseline in LIC at Week 24||0.30|-0.47|0.6628
71043353|NCT02792218|141595846|SUPERIORITY||rate ratio|0.025|||<|0.001|TWO_SIDED|95.0|0.013|0.049|||negative binomial regression model|||||0.049|0.013|<.001
71043354|NCT02792218|141595847|SUPERIORITY||rate ratio|0.26|||<|0.001|TWO_SIDED|95.0|0.21|0.33|||negative binomial regression model|||Month 12||0.33|0.21|<.001
71003502|NCT03342404|141514670|SUPERIORITY||Mean Difference (Net)|0.66||||0.0859|TWO_SIDED|95.0|-0.09|1.42|||ANCOVA|||Mean change from baseline in LIC at Week 48||1.42|-0.09|0.0859
71003503|NCT03342404|141514671|SUPERIORITY||Mean Difference (Net)|22.2||||0.0013|TWO_SIDED|95.0|5.0|38.6|||Cochran-Mantel-Haenszel|||Percentage of participants who were transfusion free over 24 weeks||38.6|5.0|0.0013
71003504|NCT03342404|141514672|SUPERIORITY||Mean Difference (Net)|37.4|||<|0.0001|TWO_SIDED|95.0|20.9|53.0|||Cochran-Mantel-Haenszel|||Percentage of Participants Who are Transfusion-Free Over 48 Weeks||53.0|20.9|< 0.0001
71003505|NCT03342404|141514674|SUPERIORITY||Mean Difference (Net)|16.15||||0.1466|TWO_SIDED|95.0|-5.73|38.04|||ANCOVA|||Mean change from baseline in 6MWT distance at Week 24||38.04|-5.73|0.1466
71003506|NCT03342404|141514674|SUPERIORITY||Mean Difference (Net)|12.44||||0.2011|TWO_SIDED|95.0|-6.72|31.59|||ANCOVA|||Mean change from baseline in 6MWT distance at Week 48||31.59|-6.72|0.2011
71003507|NCT03342404|141514675|SUPERIORITY||Mean Difference (Net)|52.1|||<|0.0001|TWO_SIDED|95.0|36.2|66.2|||Cochran-Mantel-Haenszel|||Percentage of Participants with an Increase From Baseline ≥1.5 g/dL in Mean Hemoglobin Values in the Absence of Transfusion||66.2|36.2|< 0.0001
71101118|NCT04526158|141710295|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.437|TWO_SIDED|95.0|-0.1|0.3|||Mixed Models Analysis|Linear mixed model adjusted for baseline Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.3|-0.1|0.437
71003508|NCT03342404|141514676|SUPERIORITY||Mean Difference (Net)|1.7||||0.1989|TWO_SIDED|95.0|0.8|3.7|||Cochran-Mantel-Haenszel|||Percentage of Participants With a Decrease From Baseline ≥ RD (= 1) in the Non-Transfusion Dependent β-thalassemia-Patient Reported Outcome (NTDT-PRO) Tiredness and Weakness (T/W) Domain Score Week 13 to Week 24||3.7|0.8|0.1989
71003509|NCT03342404|141514676|SUPERIORITY||Mean Difference (Net)|2.1||||0.0733|TWO_SIDED|95.0|0.9|5.0|||Cochran-Mantel-Haenszel|||Percentage of Participants With a Decrease From Baseline ≥ RD (= 1) in the Non-Transfusion Dependent β-thalassemia-Patient Reported Outcome (NTDT-PRO) Tiredness and Weakness (T/W) Domain Score Week 37 to Week 48||5.0|0.9|0.0733
71003510|NCT01957085|141514686|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.04||||||Statistical significance was set at .05 to determine statistical significance.|Chi-squared|||||||=.04
71101119|NCT04526158|141710295|SUPERIORITY||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-0.9|-0.5|||Mixed Models Analysis|Linear mixed model adjusted for baseline Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.5|-0.9|<0.001
71101120|NCT04526158|141710295|SUPERIORITY||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.0|-0.6|||Mixed Models Analysis|Linear mixed model adjusted for baseline Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.6|-1.0|<0.001
71101121|NCT04526158|141710296|SUPERIORITY||Mean Difference (Final Values)|-7.5|||||TWO_SIDED|95.0|-13.9|-1.2||Used confidence interval to determine significance.|Mixed Models Analysis|Logistic mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-1.2|-13.9|
71101122|NCT04526158|141710296|SUPERIORITY||Mean Difference (Final Values)|12.0|||||TWO_SIDED|95.0|6.4|17.6||Used confidence interval to determine significance.|Mixed Models Analysis|Logistic mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||17.6|6.4|
71101123|NCT04526158|141710296|SUPERIORITY||Mean Difference (Final Values)|19.5|||||TWO_SIDED|95.0|13.6|25.4||Used confidence interval to determine significance.|Mixed Models Analysis|Logistic mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||25.4|13.6|
71101124|NCT03533491|141710311|EQUIVALENCE|A test of the null hypothesis that the proportion of participants from pretest to posttest change is equal to zero.|Proportion Difference|0.07|STANDARD_ERROR_OF_MEAN|0.044||0.044|TWO_SIDED||||||t-test, 2 sided||A paired t-test that evaluates whether significant pretest to posttest change in the proportion of users is different from zero.|||||.044
71101125|NCT03533491|141710312|EQUIVALENCE|A test of the null hypothesis that the proportion who use from pretest to posttest is equal to zero.|Proportion Difference|0.035|STANDARD_ERROR_OF_MEAN|0.056||0.532|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether the proportion who use from pretest to posttest change is different from zero.||||||.532
71101126|NCT03533491|141710313|EQUIVALENCE|A test of the null hypothesis that the proportion of participants who use from pretest to posttest is equal to zero.|Proportion Difference|-0.053|STANDARD_ERROR_OF_MEAN|0.058||0.37|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.370
70924647|NCT04321031|141342040|SUPERIORITY||LS Mean|-43.33|||||TWO_SIDED|90.0|-62.37|-14.64||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-14.64|-62.37|
71101127|NCT03533491|141710314|EQUIVALENCE|A test of the null hypothesis that the proportion of participants that use from pretest to posttest is equal to zero.|Proportion Difference|0.14|STANDARD_ERROR_OF_MEAN|0.06||0.02|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether proportion who use from pretest to posttest is different from zero.||||||.020
71003511|NCT01957085|141514687|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Chi-squared|||||||>.05
71003512|NCT01957085|141514688|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Chi-squared|||||||>.05
71003513|NCT01957085|141514690|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Chi-squared|||||||>.05
71003514|NCT03748420|141514703|SUPERIORITY||Odds Ratio (OR)|1.29|STANDARD_ERROR_OF_MEAN|0.09845||0.0103|TWO_SIDED|95.0|1.06|1.56|||Regression, Logistic|||||1.56|1.06|0.0103
71043355|NCT02792218|141595847|SUPERIORITY||rate ratio|0.22|||<|0.001|TWO_SIDED|95.0|0.15|0.34|||negative binomial regression model|||Month 24||0.34|0.15|<.001
71043356|NCT02792218|141595847|SUPERIORITY||rate ratio|0.18|||<|0.001|TWO_SIDED|95.0|0.15|0.22|||negative binomial regression model|||End of Study||0.22|0.15|<.001
71043357|NCT02792218|141595848|SUPERIORITY||Geo-mean ratio|0.93||||0.011|TWO_SIDED|95.0|0.89|0.98|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||Month 3||0.98|0.89|0.011
71043358|NCT02792218|141595848|SUPERIORITY||Geo-mean ratio|0.73|||<|0.001|TWO_SIDED|95.0|0.69|0.77|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||Month 12||0.77|0.69|<.001
71043359|NCT02792218|141595848|SUPERIORITY||Geo-mean ratio|0.77|||<|0.001|TWO_SIDED|95.0|0.72|0.82|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||Month 24||0.82|0.72|<.001
71043360|NCT02792218|141595849|SUPERIORITY||Mean Difference (Net)|0.07||||0.118|TWO_SIDED|95.0|-0.02|0.15|||random coefficient model|||||0.15|-0.02|0.118
71043361|NCT02792218|141595852|SUPERIORITY||Hazard Ratio (HR)|0.641||||0.002|TWO_SIDED|95.0|0.486|0.847|||Regression, Cox|||||0.847|0.486|0.002
71043362|NCT02792218|141595853|SUPERIORITY||Hazard Ratio (HR)|0.657||||0.008|TWO_SIDED|95.0|0.481|0.898|||Regression, Cox|||||0.898|0.481|0.008
71043363|NCT01745952|141595877|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9819|TWO_SIDED||||||negative binomial model + overdispersion|||||||0.9819
71101128|NCT03533491|141710315|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.108||0.773|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.773
71003515|NCT03748420|141514704|SUPERIORITY||Odds Ratio (OR)|1.03|STANDARD_ERROR_OF_MEAN|0.1166||0.7967|TWO_SIDED|95.0|0.82|1.3|||Regression, Logistic|||||1.30|0.82|0.7967
71003516|NCT03748420|141514705|SUPERIORITY||Odds Ratio (OR)|1.18|STANDARD_ERROR_OF_MEAN|0.08906||0.0589|TWO_SIDED|95.0|0.99|1.41|||Regression, Logistic|||||1.41|0.99|0.0589
71003517|NCT03748420|141514706|SUPERIORITY||Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|1.0871||0.21|TWO_SIDED|95.0|-0.8|3.5|||Mixed Models Analysis|||||3.5|-0.8|0.21
71003518|NCT03748420|141514707|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.1234||0.2|TWO_SIDED|95.0|-0.4|0.1|||Mixed Models Analysis|||||0.1|-0.4|0.20
71003519|NCT03748420|141514708|SUPERIORITY||Mean Difference (Net)|-7.47|STANDARD_ERROR_OF_MEAN|59.96||0.901|TWO_SIDED|95.0|-124.99|110.04|||Mixed Models Analysis|||||110.04|-124.99|0.901
71003520|NCT00423592|141514732|SUPERIORITY_OR_OTHER||Proportion|0.0|STANDARD_DEVIATION|0.0||0.01|TWO_SIDED|95.0|0.0|9.7|||Exact binomial test|A 1-sample test for a binomial proportion was performed.||Sample size: 30 participants; 80% power to rule out 50% recurrence rate of serum ALT/AST abnormalities following ambrisentan treatment (assumes 25% recurrence rate); 99% power to rule out 75% recurrence rate (assumes 37.5% recurrence rate). H\_0 = proportion of subjects experiencing primary endpoint at 12% vs 1-sided alternative of \< 12%. P-value from exact binomial test. Summary statistics included the estimated proportion, 95% confidence interval (CI), and the p-value of the hypothesis test.||9.7|0.0|0.01
71003521|NCT00423592|141514735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.4|STANDARD_DEVIATION|49.6||0.009|TWO_SIDED|95.0|6.3|40.4|||t-test, 2 sided|||Hypothesis testing and descriptive statistics were carried out on the last-observation-carried-forward (LOCF) 6-minute walk distance change from baseline.||40.4|6.3|0.009
71003522|NCT00423592|141514736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|1.51||0.046|TWO_SIDED|95.0|-1.0|0.0|||t-test, 2 sided|||Hypothesis testing and descriptive statistics were carried out on the last-observation-carried-forward (LOCF) Borg dyspnea index change from baseline.||0.0|-1.0|0.046
71003523|NCT00423592|141514738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6|STANDARD_DEVIATION|6.44||0.001|TWO_SIDED|95.0|2.1|7.1|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||7.1|2.1|0.001
71003524|NCT00423592|141514739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4|STANDARD_DEVIATION|8.98||0.059|TWO_SIDED|95.0|-0.1|6.8|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||6.8|-0.1|0.059
71003525|NCT00423592|141514740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4|STANDARD_DEVIATION|6.86||0.002|TWO_SIDED|95.0|1.7|7.0|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||7.0|1.7|0.002
71003526|NCT00423592|141514741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.2|STANDARD_DEVIATION|10.56||0.001|TWO_SIDED|95.0|3.1|11.3|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||11.3|3.1|0.001
71043364|NCT00749411|141595910|NON_INFERIORITY|GSK233705/GW642444 were declared non-inferior to placebo for heart rate if the upper limit of the 95% confidence interval for the estimated treatment difference for weighted mean heart rate was less than +10bpm.|Mean Difference (Net)|-1.0|||||TWO_SIDED|95.0|-5.5|3.5|||||Analysis performed using a Repeated Measures Model with covariates of baseline pulse rate, sex, age, smoking status, treatment and Day and Day by treatment and Day by baseline interactions.|||3.5|-5.5|
71043365|NCT04052698|141595916|NON_INFERIORITY|1-sided test where the mean ratio is less than 0.5 utilizing a negative binomial counting regression model. One-sided alpha level of 2.5%.|Mean Difference (Final Values)|0.1645|||<|0.0001|TWO_SIDED|95.0|0.10194|0.26558|||Regression, Linear|||||0.26558|0.10194|<0.0001
71003527|NCT00423592|141514742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_DEVIATION|6.4||0.017|TWO_SIDED|95.0|0.6|5.6|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||5.6|0.6|0.017
71003528|NCT00423592|141514743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|7.45||0.046|TWO_SIDED|95.0|0.1|5.8|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||5.8|0.1|0.046
71003529|NCT00423592|141514744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5|STANDARD_DEVIATION|7.23||0.003|TWO_SIDED|95.0|1.7|7.3|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||7.3|1.7|0.003
71003530|NCT00423592|141514745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5|STANDARD_DEVIATION|9.41||0.059|TWO_SIDED|95.0|-0.1|7.2|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||7.2|-0.1|0.059
71003531|NCT00423592|141514746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|STANDARD_DEVIATION|13.96||0.152|TWO_SIDED|95.0|-1.5|9.3|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||9.3|-1.5|0.152
71003532|NCT00423592|141514747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|STANDARD_DEVIATION|5.78||0.001|TWO_SIDED|95.0|1.7|6.2|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||6.2|1.7|0.001
71003533|NCT03446612|141514748|OTHER||FBF ratio difference|0.6953|STANDARD_DEVIATION|0.12998|||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to acetylcholine (7.5 ug/min) is presented.|||||
71003534|NCT03446612|141514748|OTHER||FBF ratio difference|0.1683|||||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to acetylcholine (15 ug/min) is presented.|||||
71003535|NCT03446612|141514748|OTHER||FBF ratio difference|0.3238|||||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to acetylcholine (30 ug/min) is presented.|||||
71003536|NCT03446612|141514750|OTHER||FBF ratio difference|0.2968|||||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to sodium nitroprusside (3 ug/min) is presented.|||||
71003537|NCT03446612|141514750|OTHER||FBF ratio difference|1.4425|||||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to sodium nitroprusside (10 ug/min) is presented.|||||
71003538|NCT03446612|141514752|OTHER||FBF ratio difference|-0.1598|||||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to L-NMMA (2 umol/min) is presented.|||||
71003539|NCT03446612|141514752|OTHER||FBF ratio difference|-0.3715|||||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to L-NMMA (8 umol/min) is presented.|||||
71003540|NCT03934203|141514808|OTHER|The null hypothesis was 'The mean difference in the QTcF changes from baseline between 50 mg BI 409306 and placebo is greater than or equal to 10 milliseconds at least for one timepoint after dosing.' The one-sided tests were performed at the 5% level; due to the symmetry of the normal distribution 2-sided 90% confidence intervals for the differences of adjusted means per timepoint were used.|Difference of adjusted means|1.3|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|90.0|0.2|2.4|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Maximum difference of adjusted means was calculated as BI 409306 - placebo at 20 minutes after drug intake.|MMRM was fitted to observations for 50 mg BI 409306 and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||2.4|0.2|
71043366|NCT04052698|141595918|NON_INFERIORITY|1-sided test where the mean ratio is less than 0.5 utilizing a negative binomial counting regression model. One-sided alpha level of 2.5%.|Mean Difference (Final Values)|0.1389|||<|0.0001|TWO_SIDED|95.0|0.07664|0.25187|||Regression, Linear|||||0.25187|0.07664|<0.0001
71043367|NCT02756637|141595930|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.98|1.11||||||The Hazard Ration is the ratio of survival rates between patients with high NLR and low NLR.||1.11|0.98|
71003541|NCT03934203|141514809|OTHER|The null hypothesis was 'The mean difference in the QTcF changes from baseline between 250 mg BI 409306 and placebo is greater than or equal to 10 milliseconds at least for one timepoint after dosing.' The one-sided tests were performed at the 5% level; due to the symmetry of the normal distribution 2-sided 90% confidence intervals for the differences of adjusted means per timepoint were used.|Difference of adjusted means|5.7|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|90.0|4.4|7.1|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Maximum difference of adjusted means was calculated as BI 409306 - placebo at 40 minutes after drug intake.|MMRM was fitted to observations for 250 mg BI 409306 and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||7.1|4.4|
71003542|NCT03934203|141514810|OTHER|No formal hypotheses were tested.|Difference of adjusted means|12.1|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|90.0|10.5|13.6|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Maximum difference of adjusted means was calculated as moxifloxacin - placebo at 1 hour and 30 minutes after drug intake.|MMRM was fitted to the observations for moxifloxacin and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||13.6|10.5|
71043368|NCT02756637|141595930|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.9|1.14||||||The Hazard Ration is the ratio of survival rates between patients with high NLR and low NLR.||1.14|0.90|
71043369|NCT04947150|141595950|SUPERIORITY|||||||0.255||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA were used.||||||.255
71043370|NCT04947150|141595951|SUPERIORITY|||||||0.56||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA||||||.560
71043371|NCT04947150|141595952|SUPERIORITY|||||||0.319||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA||||||.319
71043372|NCT04947150|141595953|SUPERIORITY|||||||0.032||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA||||||.032
71043373|NCT04947150|141595954|SUPERIORITY|||||||0.044||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA||||||.044
71043374|NCT04947150|141595955|SUPERIORITY|||||||0.01||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated Measures ANOVA||||||.010
71043375|NCT04947150|141595956|SUPERIORITY|||||||0.073||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA||||||.073
71043376|NCT04947150|141595957|SUPERIORITY|||||||0.872||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA||||||.872
71043377|NCT04947150|141595958|SUPERIORITY|||||||0.145||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated Measures ANOVA||||||.145
71043378|NCT04947150|141595959|SUPERIORITY|||||||0.173||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||.173
71003543|NCT03934203|141514811|OTHER|T-Test based on the results of the MMRM (fitted to the data for all timepoints). The null hypothesis was 'The mean difference in the QTcF changes from baseline between moxifloxacin and placebo is less than or equal to 5 milliseconds at 2 hours after drug administration.'|Difference of adjusted means|11.9|STANDARD_ERROR_OF_MEAN|0.9||0|TWO_SIDED|90.0|10.4|13.4||The corresponding alpha-level according to Hochberg's adjustment for mulitplicity was 0.0167.|Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Difference of adjusted means was calculated as moxifloxacin - placebo.|MMRM was fitted to the observations for moxifloxacin and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||13.4|10.4|0.00000000
71003544|NCT03934203|141514812|OTHER|T-Test based on the results of the MMRM (fitted to the data for all timepoints). The null hypothesis was 'The mean difference in the QTcF changes from baseline between moxifloxacin and placebo is less than or equal to 5 milliseconds at 3 hours after drug administration.'|Difference of adjusted means|11.1|STANDARD_ERROR_OF_MEAN|1.0||3e-08|TWO_SIDED|90.0|9.3|12.8||The corresponding alpha-level according to Hochberg's adjustment for mulitplicity was 0.0250.|Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Difference of adjusted means was calculated as moxifloxacin - placebo.|MMRM was fitted to the observations for moxifloxacin and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||12.8|9.3|0.00000003
71003545|NCT03934203|141514813|OTHER|T-Test based on the results of the MMRM (fitted to the data for all timepoints). The null hypothesis was 'The mean difference in the QTcF changes from baseline between moxifloxacin and placebo is less than or equal to 5 milliseconds at 4 hours after drug administration.'|Difference of adjusted means|10.7|STANDARD_ERROR_OF_MEAN|1.1||2e-07|TWO_SIDED|90.0|8.9|12.4||The corresponding alpha-level according to Hochberg's adjustment for mulitplicity was 0.050.|Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Difference of adjusted means was calculated as moxifloxacin - placebo.|MMRM was fitted to the observations for moxifloxacin and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||12.4|8.9|0.00000020
71003546|NCT03934203|141514814|OTHER|No formal hypotheses were tested.|Difference of adjusted means|2.4|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|1.4|3.3|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Maximum difference of adjusted means was calculated as BI 409306 - placebo at 20 minutes after drug intake.|MMRM was fitted to observations for 50 mg BI 409306 and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||3.3|1.4|
71003547|NCT03934203|141514815|OTHER|No formal hypotheses were tested.|Difference of adjusted means|11.7|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|90.0|10.6|12.8|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Maximum difference of adjusted means was calculated as BI 409306 - placebo at 40 minutes after drug intake.|MMRM was fitted to observations for 250 mg BI 409306 and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||12.8|10.6|
71003548|NCT03934203|141514816|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.2|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-2.3|-0.1|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Minimum difference of adjusted means was calculated as BI 409306 - placebo at 24 hours after drug intake.|MMRM was fitted to observations for 50 mg BI 409306 and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||-0.1|-2.3|
71008617|NCT02055976|141525234|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|15.429|STANDARD_ERROR_OF_MEAN|2.662|<|0.001|TWO_SIDED|95.0|10.141|20.717|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||20.717|10.141|<0.001
71043379|NCT04947150|141595960|SUPERIORITY|||||||0.012||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||.012
71043380|NCT04947150|141595961|SUPERIORITY|||||||0.008||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||.008
70924648|NCT04321031|141342040|SUPERIORITY||LS Mean|-59.35|||||TWO_SIDED|90.0|-73.95|-36.55||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-36.55|-73.95|
71003549|NCT03934203|141514817|OTHER|No formal hypotheses were tested.|Difference of adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|90.0|-1.3|1.3|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Minimum difference of adjusted means was calculated as BI 409306 - placebo at 12 hours after drug intake.|MMRM was fitted to observations for 250 mg BI 409306 and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||1.3|-1.3|
71003550|NCT00608842|141514837|SUPERIORITY_OR_OTHER||Difference to placebo|0.0|||||TWO_SIDED|95.0|-18.4|20.4||||||Complete Clearance||20.4|-18.4|
71003551|NCT00608842|141514837|SUPERIORITY_OR_OTHER||Difference to placebo|0.0|||||TWO_SIDED|95.0|-18.4|20.4||||||Complete Clearance||20.4|-18.4|
71003552|NCT00608842|141514837|SUPERIORITY_OR_OTHER||Difference to placebo|7.1|||||TWO_SIDED|95.0|-12.2|31.5||||||Complete Clearance||31.5|-12.2|
71003553|NCT00608842|141514837|SUPERIORITY_OR_OTHER||Difference to placebo|1.6|||||TWO_SIDED|95.0|-23.0|27.5||||||≥ 75% Cleared||27.5|-23.0|
71003554|NCT00608842|141514837|SUPERIORITY_OR_OTHER||Difference to placebo|-5.1|||||TWO_SIDED|95.0|-28.3|19.6||||||≥ 75% Cleared||19.6|-28.3|
71003555|NCT00608842|141514837|SUPERIORITY_OR_OTHER||Difference to placebo|2.5|||||TWO_SIDED|95.0|-22.3|29.5||||||≥ 75% Cleared||29.5|-22.3|
71003556|NCT03787095|141514845|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||Null hypothesis: There is no change from baseline to post-baseline among participants treated with Cemiplimab. Per the analysis plan, only participants in the Cemiplimab arm are evaluated.||||0.71
71003557|NCT03787095|141514846|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Null hypothesis: There is no change from baseline to post-baseline among participants treated with Cemiplimab. Per the analysis plan, only participants in the Cemiplimab arm are evaluated.||||1.00
71003558|NCT03787095|141514847|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||Null hypothesis: There is no change from baseline to post-baseline among participants treated with Cemiplimab. Per the analysis plan, only participants in the Cemiplimab arm are evaluated.||||0.33
71003559|NCT01838304|141514888|OTHER||Odds Ratio (OR)|7.9|||<|0.0001|TWO_SIDED|95.0|4.21|14.81|||Fisher Exact|||Fisher's exact test for odd's ratio of time below a saturation of 80% to total time||14.81|4.21|<0.0001
71003560|NCT03028467|141514941|OTHER||Mean Difference (Net)|-1.111|||||TWO_SIDED|95.0|-2.7186|0.4965|||||Week 1. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.4965|-2.7186|
71043381|NCT04947150|141595962|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||<.001
71043382|NCT04947150|141595963|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||<.001
71043383|NCT04947150|141595964|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||<.001
71003561|NCT03028467|141514941|OTHER||Mean Difference (Net)|-0.5177|||||TWO_SIDED|95.0|-1.904|0.8685|||||Week 1. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.8685|-1.9040|
71003562|NCT03028467|141514941|OTHER||Mean Difference (Net)|-0.5332|||||TWO_SIDED|95.0|-1.914|0.8475|||||Week 1. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.8475|-1.9140|
71003563|NCT03028467|141514941|OTHER||Mean Difference (Net)|-1.1387|||||TWO_SIDED|95.0|-2.8848|0.6075|||||Week 2. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.6075|-2.8848|
71003564|NCT03028467|141514941|OTHER||Mean Difference (Net)|-0.8905|||||TWO_SIDED|95.0|-2.3962|0.6153|||||Week 2. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.6153|-2.3962|
71003565|NCT03028467|141514941|OTHER||Mean Difference (Net)|-0.8047|||||TWO_SIDED|95.0|-2.3045|0.6951|||||Week 2. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.6951|-2.3045|
71043384|NCT04947150|141595965|SUPERIORITY|||||||0.382||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||.382
71043385|NCT04947150|141595966|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated Measures ANOVA||||||<.001
71043386|NCT04947150|141595967|SUPERIORITY|||||||0.178||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.178
71043387|NCT04947150|141595968|SUPERIORITY|||||||0.081||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.081
71043388|NCT04947150|141595969|SUPERIORITY|||||||0.343||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.343
71043389|NCT04947150|141595970|SUPERIORITY|||||||0.369||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.369
71043390|NCT04947150|141595971|SUPERIORITY|||||||0.055||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.055
71043391|NCT04947150|141595974|SUPERIORITY|||||||0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.001
71043392|NCT04947150|141595975|SUPERIORITY|||||||0.079||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.079
71043393|NCT04947150|141595976|SUPERIORITY|||||||0.581||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.581
71003566|NCT03028467|141514941|OTHER||Mean Difference (Net)|-1.4575|||||TWO_SIDED|95.0|-3.6013|0.6863|||||Week 4. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.6863|-3.6013|
71003567|NCT03028467|141514941|OTHER||Mean Difference (Net)|-0.8894|||||TWO_SIDED|95.0|-2.7381|0.9593|||||Week 4. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.9593|-2.7381|
71003568|NCT03028467|141514941|OTHER||Mean Difference (Net)|-1.1615|||||TWO_SIDED|95.0|-3.0028|0.6799|||||Week 4. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.6799|-3.0028|
71003569|NCT03028467|141514941|OTHER||Mean Difference (Net)|-0.3209|||||TWO_SIDED|95.0|-2.3021|1.6603|||||Week 6. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.6603|-2.3021|
71003570|NCT03028467|141514941|OTHER||Mean Difference (Net)|-0.1876|||||TWO_SIDED|95.0|-1.896|1.5209|||||Week 6. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.5209|-1.8960|
71003571|NCT03028467|141514941|OTHER||Mean Difference (Net)|-0.4593|||||TWO_SIDED|95.0|-2.161|1.2424|||||Week 6. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.2424|-2.1610|
71003572|NCT03028467|141514941|OTHER||Mean Difference (Net)|-0.6521|||||TWO_SIDED|95.0|-3.1342|1.83|||||Week 8. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.8300|-3.1342|
71003573|NCT03028467|141514941|OTHER||Mean Difference (Net)|-0.5499|||||TWO_SIDED|95.0|-2.6903|1.5904|||||Week 8. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.5904|-2.6903|
71003574|NCT03028467|141514941|OTHER||Mean Difference (Net)|-0.9665|||||TWO_SIDED|95.0|-3.0984|1.1654|||||Week 8. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.1654|-3.0984|
71003575|NCT03028467|141514941|OTHER||Mean Difference (Net)|-0.3576|||||TWO_SIDED|95.0|-3.0892|2.374|||||Week 12. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||2.3740|-3.0892|
71003576|NCT03028467|141514941|OTHER||Mean Difference (Net)|0.1851|||||TWO_SIDED|95.0|-2.1704|2.5407|||||Week 12. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||2.5407|-2.1704|
71003577|NCT03028467|141514941|OTHER||Mean Difference (Net)|-0.1181|||||TWO_SIDED|95.0|-2.4643|2.2281|||||Week 12. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||2.2281|-2.4643|
71003578|NCT03028467|141514941|OTHER||Mean Difference (Net)|-1.4276|||||TWO_SIDED|95.0|-3.6569|0.8018|||||Week 22 (Follow up). The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.8018|-3.6569|
71003579|NCT03028467|141514941|OTHER||Mean Difference (Net)|0.5415|||||TWO_SIDED|95.0|-1.381|2.4639|||||Week 22 (Follow up). The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||2.4639|-1.3810|
71003580|NCT03028467|141514941|OTHER||Mean Difference (Net)|-0.7932|||||TWO_SIDED|95.0|-2.708|1.1217|||||Week 22 (Follow up). The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.1217|-2.7080|
71003581|NCT01387594|141514943|SUPERIORITY_OR_OTHER_LEGACY||Geometric Mean Ratio (GMR)|1.33|||||TWO_SIDED|80.0|1.13|1.56||A p-value was not computed; hypothesis was tested using confidence interval (CI) approach.|||The lower limit of 80% CI greater than 0.5 indicates the statistical significance at alpha=0.1 level.|The null hypothesis is the (median) percent decrease in total lymphocytes count is greater or equal to 50%, equivalently indicating that the geometric mean ratio (GMR: post-treatment/pretreatment) in total lymphocyte counts is less than or equal to 0.5.||1.56|1.13|
71008618|NCT02055976|141525234|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|12.321|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|6.959|17.683|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||17.683|6.959|<0.001
71008619|NCT02055976|141525234|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.804|STANDARD_ERROR_OF_MEAN|3.041||0.014|TWO_SIDED|95.0|0.761|12.847|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||12.847|0.761|0.014
71008620|NCT02055976|141525234|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.565|STANDARD_ERROR_OF_MEAN|3.023|<|0.001|TWO_SIDED|95.0|4.556|16.573|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||16.573|4.556|<0.001
71043394|NCT04947150|141595977|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||<.001
71003582|NCT03991468|141514947|NON_INFERIORITY|A Mixed Model Repeated Measures logistic regression was used to prove WSI major discordance (MD) rate non-inferior to Glass MD rate. A two-sided 95% CI for the difference in MD rate was constructed. If the upper bound of the 95% CI was less than the non-inferiority margin of 4%, then WSI would be considered non-inferior to Glass, assuming power = 0.9 and alpha = 0.05 a sample size of 2000 was calculated to be sufficient to prove non-inferiority.|Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.1|1.0|||Mixed Models Analysis|Dependent var = major discordance status (yes/no); independent var = modality (WSI/Glass) as a fixed effect \& site, reader, \& case as random effects.||||1.0|-0.1|
71003583|NCT03573804|141514949|OTHER|A two-tailed paired T-test for equivalence was used to evaluate equivalence between the average raw tumor.|Mean Difference (Net)|224.675|STANDARD_ERROR_OF_MEAN|67.89|<|0.001|TWO_SIDED|95.0|90.26044|359.08956||Using an alpha value of 0.05, dof = 60, the null hypothesis of sample mean equivalence was rejected.|t-test, 2 sided|A paired two-tailed t-test was used on the paired prone-to-supine tumor intensity values.||Regions of interest (ROIs) for tumor were defined by the radiologist segmentation of tumor in supine and prone positions. ROIs for the surrounding tissue were selected such that tumor and normal regions had equal volumes. The alpha level was assumed to be of 0.05 (dof = 60), and the null hypothesis of equivalence (mu = 0).||359.08956|90.26044|<0.001
71003584|NCT03573804|141514950|OTHER|A two-tailed paired T-test was used to compare sample means in between the prone and supine mean benign tissue intensities.|Mean Difference (Net)|165.833|STANDARD_ERROR_OF_MEAN|44.19|<|0.001|TWO_SIDED|95.0|78.34708|253.31892||Using an alpha value of 0.05, dof = 60, the null hypothesis of sample mean equivalence was rejected.|t-test, 2 sided|A paired two-tailed t-test was used on the paired prone-to-supine normal tissue intensity values.||Regions of interest (ROIs) for surrounding tissues were selected as the surrounding benign tissue regions directly adjacent to the segmented tumor regions. Tumor and surrounding regions had equal volumes. The mean surrounding region intensities reported were all calculated from the prone and supine T1-weighted MR images segmented by the radiologist.||253.31892|78.34708|<0.001
71003585|NCT03573804|141514951|OTHER|A two-tailed paired T-test was used to compare sample means in between the prone and supine tumor-to-surrounding tissue ratios.|Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.08||0.0058|TWO_SIDED|95.0|-0.04209|0.28209||Using an alpha value of 0.05, dof = 60, the null hypothesis of sample mean equivalence was rejected.|t-test, 2 sided|A two-tailed paired T-test was used to compare sample means in between the prone and supine tumor-to-surrounding tissue ratios.||The ratios of tumor-to-surrounding tissue intensities, as calculated in Secondary Objective Part A, were compared between prone and supine T1-weighted MR image scans.||0.28209|-0.04209|0.0058
71003586|NCT03573804|141514953|SUPERIORITY|||||||0.00049664|||||||Students two-tailed paired t-test|||||||0.00049664
71043395|NCT04947150|141595978|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||<.001
71043396|NCT04947150|141595979|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||<.001
71043397|NCT04947150|141595980|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||<.001
71043398|NCT04947150|141595984|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|Paired Sample T-test||||||<.05
71043399|NCT04947150|141595986|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|Paired samples t-test||||||.006
71043400|NCT04947150|141595987|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|Paired samples t-test||||||<.001
71043401|NCT04947150|141595988|SUPERIORITY|||||||0.22|||||||t-test, 2 sided|Paired samples t-test||||||.220
71043402|NCT04947150|141595989|SUPERIORITY|||||||0.623|||||||t-test, 2 sided|Paired samples t-test||||||.623
71043403|NCT04947150|141595990|SUPERIORITY|||||||0.577||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.577
71043404|NCT04947150|141595991|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||<.001
71043405|NCT04947150|141595992|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||<.001
71043406|NCT04947150|141595993|SUPERIORITY|||||||0.008||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.008
71043407|NCT04947150|141595994|SUPERIORITY|||||||0.601||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated Measures ANOVA||||||.601
71043408|NCT04947150|141595995|SUPERIORITY|||||||0.088||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.088
71043409|NCT04947150|141595996|SUPERIORITY|||||||0.21||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.210
71043410|NCT04947150|141595997|SUPERIORITY|||||||0.06||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.060
71043411|NCT04947150|141595998|SUPERIORITY|||||||0.37||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.370
71043412|NCT04947150|141595999|SUPERIORITY|||||||0.556||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated Measures ANOVA||||||.556
71043413|NCT04947150|141596000|SUPERIORITY|||||||0.913||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.913
71043414|NCT04947150|141596001|SUPERIORITY|||||||0.241||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated Measures ANOVA||||||.241
71101129|NCT03533491|141710316|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.08||0.978|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.978
71101130|NCT03533491|141710317|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|0.029|STANDARD_ERROR_OF_MEAN|0.089||0.745|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.745
71101131|NCT03533491|141710318|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|-0.154|STANDARD_ERROR_OF_MEAN|0.101||0.132|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.132
71043415|NCT02449473|141596002|SUPERIORITY|The model included treatment group as fixed effect and baseline log-transformed airway submucosal eosinophils as a continuous covariate. No interaction terms were included in the model. The analysis was performed using log-transformed data. All group comparisons from analysis of covariance (ANCOVA) model were based on Type III sums of squares.|Least square (LS) geometric mean ratio|1.43||||0.3862|TWO_SIDED|95.0|0.63|3.27|||ANCOVA|||Comparison of change from baseline, expressed as a ratio, in airway submucosal eosinophils; Tralo 300 mg Q2W vs placebo. The null hypothesis was that the change in airway submucosal eosinophils at Week 12 on tralokinumab was equal to the corresponding change on placebo.||3.27|0.63|0.3862
70924649|NCT04321031|141342040|SUPERIORITY||LS Mean|-68.21|||||TWO_SIDED|90.0|-79.72|-50.15||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-50.15|-79.72|
70924650|NCT04321031|141342040|SUPERIORITY||LS Mean|-50.46|||||TWO_SIDED|90.0|-69.53|-19.44||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-19.44|-69.53|
71043416|NCT02449473|141596003|SUPERIORITY|The repeated measures analysis included treatment group, baseline log-transformed eosinophils and visit as fixed effects. Treatment-by-visit interaction was also included. The analysis was performed using log-transformed data. A restricted maximum likelihood (REML) approach was used. An unstructured variance-covariance matrix was used to model the within-subject errors.|LS geometric mean ratio|1.21||||0.0546|TWO_SIDED|95.0|1.0|1.48|||Repeated measures analysis|||Comparison of change from baseline, expressed as a ratio, in blood eosinophil count; Tralo 300 mg Q2W vs placebo.||1.48|1.00|0.0546
71043417|NCT02449473|141596004|SUPERIORITY|The repeated measures analysis included treatment group, baseline log-transformed differential sputum eosinophils and visit as fixed effects. Treatment-by-visit interaction was also included. The analysis was performed using log-transformed data. A REML approach was used. An unstructured variance-covariance matrix was used to model the within-subject errors.|LS geometric mean ratio|0.57||||0.6334|TWO_SIDED|95.0|0.06|6.0|||Repeated measures analysis|||Comparison of change from baseline, expressed as a ratio, in differential sputum eosinophils; Tralo 300 mg Q2W vs placebo.||6.00|0.06|0.6334
71043418|NCT02449473|141596005|SUPERIORITY|The repeated measures analysis included treatment group, baseline log-transformed blood free ECP and visit as fixed effects. Treatment-by-visit interaction was also included. The analysis was performed using log-transformed data. A REML approach was used. An unstructured variance-covariance matrix was used to model the within-subject errors.|LS geometric mean ratio|1.11||||0.3769|TWO_SIDED|95.0|0.88|1.4|||Repeated measures analysis|||Comparison of change from baseline, expressed as a ratio, in blood free ECP concentration; Tralo 300 mg Q2W vs placebo.||1.40|0.88|0.3769
71043419|NCT02449473|141596006|SUPERIORITY|The repeated measures analysis included treatment group, baseline log-transformed sputum free ECP and visit as fixed effects. Treatment-by-visit interaction was also included. The analysis was performed using log-transformed data. A REML approach was used. An unstructured variance-covariance matrix was used to model the within-subject errors.|LS geometric mean ratio|0.49||||0.1126|TWO_SIDED|95.0|0.2|1.2|||Repeated measures analysis|||Comparison of change from baseline, expressed as a ratio, in sputum free ECP concentration; Tralo 300 mg Q2W vs placebo.||1.20|0.20|0.1126
71043420|NCT04034355|141596007|SUPERIORITY||Risk Ratio (RR)|1.521||||0.028|TWO_SIDED|95.0|1.0462|2.2113|||Cochran-Mantel-Haenszel|||||2.2113|1.0462|0.0280
71043421|NCT02190279|141596019|OTHER|||||||0.0033|||||||ANOVA|||At 1 hour post injection.||||0.0033
71043422|NCT02190279|141596019|OTHER|||||||0.012|||||||ANOVA|||At 2 hour post injection.||||0.012
71043423|NCT02190279|141596020|EQUIVALENCE|One way analysis variance.|||||<|0.05|||||||variance|||||||<0.05
71043424|NCT00455962|141596048|SUPERIORITY|||||||0.69|||||||t-test, 2 sided|||Using previously collected data from a group of 18 predominantly Caucasian women undergoing a similar infusion we determined that 22 women would be necessary to identify a 30% difference in peak LH levels, the primary outcome measure, between AAW and CW with 80% power at a significance level of 0.05.||||0.69
71043425|NCT01197417|141596049|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||Van Elteren test|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment||Null hypothesis of equal distributions of primary length of stay between treatment arms within all randomization strata||||0.24
71043426|NCT01197417|141596050|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Van Elteren test|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.||||||0.12
71043427|NCT01197417|141596051|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Mantel Haenszel|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.||||||0.39
71003587|NCT01425307|141514954|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|We hypothesized that the Alternative arm mean TCD velocity at 24 months will be less than the Standard arm mean TCD velocity plus 15cm/sec. We used Lan-DeMets boundaries to control overall Type I error rate at α = 0.05. For looks at exactly 1/3, 2/3, and 100 percent of the completed subjects, the cumulative α were estimated to be 0.0001, 0.001, and 0.05, respectively.|Mean Difference (Final Values)|4.54|||<|0.05|TWO_SIDED|95.0|0.1|8.98||P value for non inferiority was 8.82 X 10\^-16|Mixed Models Analysis|Linear mixed model||Participants were randomized at a central site, stratified by site with a block size of four, and an adaptive randomization scheme was used to balance the covariates of baseline age and TCD velocity. The treatment period lasted 24 months. The primary study endpoint was the 24 month TCD velocity calculated from a general linear mixed model, with the non-inferiority margin set at 15 cm/s. The primary analysis was done in the intention-to-treat population.||8.98|0.10|<0.05
71003588|NCT01425307|141514958|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71043428|NCT01197417|141596052|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mantel Haenszel|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.||||||<0.01
71003589|NCT01425307|141514968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011|||||||t-test, 2 sided|||||||0.0011
71003590|NCT04058990|141514972|NON_INFERIORITY|13.2% non-inferiority margin||||||0.0012|||||||Farrington-Manning|||\[Not Specified\]||||0.0012
71003591|NCT04852666|141514974|SUPERIORITY|||||||0.751|||||||t-test, 2 sided|||||||0.751
71003592|NCT04852666|141514974|SUPERIORITY|||||||0.372|||||||t-test, 2 sided|||||||0.372
71003593|NCT04852666|141514975|SUPERIORITY|||||||0.778|||||||t-test, 2 sided|||||||0.778
71003594|NCT04852666|141514975|SUPERIORITY|||||||0.357|||||||t-test, 2 sided|||||||0.357
71043429|NCT01197417|141596053|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Mantel Haenszel|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.||||||0.11
71043430|NCT01197417|141596054|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Van Elteren test|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.||||||0.78
71043431|NCT01197417|141596055|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Van Elteren test|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.||||||0.46
71043432|NCT01652729|141596056|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.2167||0.001|TWO_SIDED|95.0|-1.15|-0.3|||mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||-0.30|-1.15|0.0010
71003595|NCT04852666|141514976|SUPERIORITY|||||||0.012|||||||Chi-squared|||||||0.012
71003596|NCT04852666|141514976|SUPERIORITY|||||||0.956|||||||Chi-squared|||||||0.956
71003597|NCT04852666|141514977|SUPERIORITY|||||||0.103|||||||Chi-squared|||||||0.103
71003598|NCT04852666|141514977|SUPERIORITY|||||||0.025|||||||Chi-squared|||||||0.025
71003599|NCT04852666|141514978|SUPERIORITY|||||||0.785|||||||t-test, 2 sided|||||||0.785
71003600|NCT04852666|141514979|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.200
71003601|NCT04852666|141514980|SUPERIORITY|||||||0.887|||||||t-test, 2 sided|||||||0.887
71003602|NCT04852666|141514980|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||||||0.204
71003603|NCT03050307|141514981|NON_INFERIORITY|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|-3.7|||||TWO_SIDED|95.0|-10.966|3.339||||||||3.339|-10.966|
71003604|NCT03050307|141514982|NON_INFERIORITY|If the primary outcome measure was met, then the hypothesis for this outcome measure was that if the lower bound of the 95% CI of the difference was ≥-10%, noninferiority for TAK-438 relative to lansoprazole with regard to H pylori eradication was declared.|Exact (Clopper-Pearson)|7.2|||||TWO_SIDED|95.0|-4.469|18.825||||||||18.825|-4.469|
71003605|NCT03050307|141514983|NON_INFERIORITY|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|-6.0|||||TWO_SIDED|95.0|-16.644|4.741||||||||4.741|-16.644|
71003606|NCT03050307|141514984|OTHER|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|-1.1|||||TWO_SIDED|95.0|-25.175|23.07||||||Epigastric Pain (Postprandial)||23.070|-25.175|
71003607|NCT03050307|141514984|NON_INFERIORITY|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|4.5|||||TWO_SIDED|95.0|-11.907|20.931||||||Epigastric Pain (Fasting/Nocturnal)||20.931|-11.907|
71003608|NCT03050307|141514984|NON_INFERIORITY|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|16.0|||||TWO_SIDED|95.0|-11.255|43.321||||||Abdominal Bloating||43.321|-11.255|
71043433|NCT01652729|141596056|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.1638||0.0209|TWO_SIDED|95.0|-0.7|-0.06|||mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||-0.06|-0.70|0.0209
71043434|NCT01652729|141596056|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.2278||0.1347|TWO_SIDED|95.0|-0.79|0.11|||mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||0.11|-0.79|0.1347
71043435|NCT01652729|141596057|SUPERIORITY_OR_OTHER|||||||0.0489|||||||Cochran-Mantel-Haenszel|||Percentage of Subjects Achieving HbA1c \<7% at Week 28.||||0.0489
71043436|NCT01652729|141596057|SUPERIORITY_OR_OTHER|||||||0.0103|||||||Cochran-Mantel-Haenszel|||Percentage of Subjects Achieving HbA1c \<7% at Week 28.||||0.0103
71043437|NCT01652729|141596058|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.1|STANDARD_ERROR_OF_MEAN|5.96||0.0924|TWO_SIDED|95.0|-21.8|1.7|||mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||1.7|-21.8|0.0924
71003609|NCT03050307|141514984|NON_INFERIORITY|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|10.1|||||TWO_SIDED|95.0|-5.109|25.348||||||Heartburn||25.348|-5.109|
71003610|NCT03050307|141514984|NON_INFERIORITY|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|-12.2|||||TWO_SIDED|95.0|-45.138|20.694||||||Lack of Appetite||20.694|-45.138|
71003611|NCT01998906|141514986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.6||||0.0051|TWO_SIDED|95.0|5.0|30.2|||Chi-squared|||||30.2|5.0|0.0051
71003612|NCT01998906|141514987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.3||||0.0014|TWO_SIDED|95.0|7.2|31.4|||Chi-squared|||||31.4|7.2|0.0014
71003613|NCT01998906|141514988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4||||0.3077|TWO_SIDED|95.0|-6.4|19.1|||Chi-squared|||||19.1|-6.4|0.3077
71003614|NCT01998906|141514990|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.0275|TWO_SIDED|95.0|0.44|0.96|||Log Rank|||||0.96|0.44|0.0275
71003615|NCT01998906|141514992|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59||||0.0555|TWO_SIDED|95.0|0.35|1.02|||Log Rank|||||1.02|0.35|0.0555
71003616|NCT01077193|141515009|NON_INFERIORITY_OR_EQUIVALENCE|See above.|Mean Percent Excess Weight Loss|37.9|STANDARD_DEVIATION|25.18||0.3227|TWO_SIDED|95.0|30.2|45.5||No multiple comparison adjustments are necessary as this is a single hypothesis on 1 parameter for a within group change comparison to 36.1%.|t-test, 1 sided|||A sample size of 32 achieves power\>90% to demonstrate non-inferiority using a one-sided t-test (alpha=0.025) when the margin of equivalence is a 5% difference in EWL. The true difference between %EWL for patients undergoing a greater curvature procedure and the target %EWL is hypothesized to be 0. The target %EWL at 3 years is 41.1%, based upon prior studies. This power analysis assumes data are drawn from a single population with a standard deviation of 8.20.||45.5|30.2|0.3227
71003617|NCT04283773|141515014|SUPERIORITY||Median Difference (Final Values)|0.001|STANDARD_DEVIATION|1.5||0.001|TWO_SIDED|95.0|0.0|8.0||The test of significance is Kruskal Wallis was used to examine the Difference in Median between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons . A p-value \< 0.05 was considered significant.|Kruskal-Wallis|||Assessment of statistical differences in P16 expression between 3 groups. The immunohistochemical evaluation is done using German- semiquantitative scoring system. The score ranges from ( 0, 1,2,3,4,6,8,9 and 12). The data will entered on SPSS,version 24 as numbers. The test of significance is Kruskal Wallis was used to examine the Difference in Median between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons . A p-value \< 0.05 was considered significant.||8|0|0.001
71008621|NCT02055976|141525234|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|12.895|STANDARD_ERROR_OF_MEAN|2.969|<|0.001|TWO_SIDED|95.0|6.993|18.796|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||18.796|6.993|<0.001
71003618|NCT04283773|141515015|SUPERIORITY||Hazard Ratio, log|0.009||||0.009|TWO_SIDED|95.0|0.0|8.0||Data were analysed using IBM-SPSS version 24. Correlation analysis was used (Spearman' Ranked correlation, 2-tailed). A p-value \< 0.05 was considered significant.|Spearman's rank correlation coefficient(|||Correlation between Ki 67 expression using percentage of Ki67 positive nuclei and P16 cytoplasmic expression using German semi quantitative score among MOGCT group. Data were analysed using IBM-SPSS version 24. Correlation analysis was used (Spearman' Ranked correlation, 2-tailed). A p-value \< 0.05 was considered significant.||8|0|0.009
71043438|NCT01652729|141596058|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.9|STANDARD_ERROR_OF_MEAN|8.037||0.0001|TWO_SIDED|95.0|-46.7|-15.1|||mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||-15.1|-46.7|0.0001
71043439|NCT01652729|141596059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.4058||0.8625|TWO_SIDED|95.0|-0.73|0.87||Nominal p-value|mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||0.87|-0.73|0.8625
71043440|NCT01652729|141596059|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.5419||0.0198|TWO_SIDED|95.0|-2.34|-0.2||Nominal p-value|mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||-0.20|-2.34|0.0198
71043441|NCT01652729|141596060|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.96|STANDARD_ERROR_OF_MEAN|15.71||0.0248|TWO_SIDED|95.0|-67.23|-4.68||Nominal p-value|general linear model|Includes treatment and baseline HbA1c (\< 9% or ≥ 9%) as fixed factors, and baseline 2-hour postprandial plasma glucose concentrations as a covariate.||||-4.68|-67.23|0.0248
71043442|NCT01652729|141596060|SUPERIORITY_OR_OTHER||LS Mean Difference|-20.89|STANDARD_ERROR_OF_MEAN|19.66||0.2914|TWO_SIDED|95.0|-60.02|18.25||Nominal p-value|general linear model|Includes treatment and baseline HbA1c (\< 9% or ≥ 9%) as fixed factors, and baseline 2-hour postprandial plasma glucose concentrations as a covariate.||||18.25|-60.02|0.2914
71043443|NCT01311557|141596061|NON_INFERIORITY_OR_EQUIVALENCE|"A two-sided 95% confidence interval (CI) was constructed around each of the ratios: Pertussis toxoid (PT) GMT Group 1 / GMT Group 2.~The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was \> 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025."|GMT Ratio|0.94|||||TWO_SIDED|95.0|0.843|1.05||||||||1.05|0.843|
71043444|NCT01311557|141596061|NON_INFERIORITY_OR_EQUIVALENCE|"A two-sided 95% CI was constructed around each of the ratios: anti-Filamentous hemagglutinin (FHA) GMT Group 1 / GMT Group 2.~The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was \> 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025."|GMT Ratio|1.03|||||TWO_SIDED|95.0|0.944|1.13||||||||1.13|0.944|
71043445|NCT01311557|141596061|NON_INFERIORITY_OR_EQUIVALENCE|"A two-sided 95% CI was constructed around each of the ratios: Anti-Pertactin (PRN) GMT Group 1 / GMT Group 2.~The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was \> 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025."|GMT Ratio|1.05|||||TWO_SIDED|95.0|0.928|1.18||||||||1.18|0.928|
71043446|NCT01311557|141596061|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was constructed around each of the ratios: anti-Fimbriae types 2 and 3 (FIM) GMT Group 1 / GMT Group 2. The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was \> 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025.|GMT Ratio|0.882|||||TWO_SIDED|95.0|0.731|1.06||||||||1.06|0.731|
71043447|NCT03478865|141596067|SUPERIORITY||Mean Difference (Final Values)|-2.54||||0.259|TWO_SIDED|95.0|-7.91|2.83||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the treatment completion visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the treatment completion visit (Month 2 for Cohort 1)."||2.83|-7.91|0.259
71043448|NCT03478865|141596067|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.818|TWO_SIDED|95.0|-4.66|4.12||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the treatment completion visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the treatment completion visit (Month 1 for Cohort 2)."||4.12|-4.66|0.818
71043449|NCT03478865|141596068|SUPERIORITY||Mean Difference (Final Values)|-3.56||||0.365|TWO_SIDED|95.0|-13.24|6.12||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the post-treatment follow-up visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the post-treatment follow-up visit (Month 3 for Cohort 1)."||6.12|-13.24|0.365
71043450|NCT03478865|141596068|SUPERIORITY||Mean Difference (Final Values)|3.23||||0.48|TWO_SIDED|95.0|-12.94|19.41||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the post-treatment follow-up visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the post-treatment follow-up visit (Month 2 for Cohort 2)."||19.41|-12.94|0.480
71043451|NCT02418455|141596081|SUPERIORITY||LS Mean|-61.0|STANDARD_ERROR_OF_MEAN|6.409|<|0.0001|TWO_SIDED|95.0|-73.56|-48.44||P-values are from generalized estimating equation (GEE) model including baseline value and visit as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||||-48.44|-73.56|< 0.0001
71003619|NCT04283773|141515016|SUPERIORITY|One-way ANOVA was used to examine the Difference in Mean between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons .Data was expressed as mean (SD). P value is significant if less than 0.05.|Mean Difference (Final Values)|11.0|STANDARD_DEVIATION|1.5||0.699|TWO_SIDED|80.0|9.5|13.0||One-way ANOVA was used to examine the Difference in Mean between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons .Data was expressed as mean (SD). P value is significant if less than 0.05.|ANOVA|||Correlation between P16 cytoplasmic score using German semi-quantitative system and FIGO staging of MOGCTs was done via One-way ANOVA was used to examine the Difference in Mean between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons .Data was expressed as mean (SD).||13|9.5|0.699
71003620|NCT06048809|141515019|OTHER|||||||2.36e-05|||||||ANCOM-BC2|||Haemophilus parainfluenzae: Change From Baseline at Week 6||||0.0000236
71003621|NCT06048809|141515019|OTHER|||||||0.0033243|||||||ANCOM-BC2|||Neisseria elongata: Change From Baseline at Week 6||||0.0033243
71003622|NCT06048809|141515019|OTHER|||||||0.00500088|||||||ANCOM-BC2|||Aggregatibacter sp.\_HMT\_898: Change From Baseline at Week 6||||0.00500088
71003623|NCT06048809|141515019|OTHER|||||||0.0066975|||||||ANCOM-BC2|||Parvimonas sp.\_HMT\_110: Change From Baseline at Week 6||||0.0066975
71003624|NCT06048809|141515019|OTHER|||||||0.00710228|||||||ANCOM-BC2|||Aggregatibacter aphrophilus: Change From Baseline at Week 6||||0.00710228
71003625|NCT06048809|141515019|OTHER|||||||0.00744022|||||||ANCOM-BC2|||Kingella oralis: Change From Baseline at Week 6||||0.00744022
71003626|NCT06048809|141515019|OTHER|||||||0.01434037|||||||ANCOM-BC2|||Haemophilus sp.\_HMT\_036: Change From Baseline at Week 6||||0.01434037
71043452|NCT02418455|141596089|SUPERIORITY|||||||0.2655|||||||t-test|||||||0.2655
71043453|NCT02418455|141596090|SUPERIORITY||LS Mean|-0.99|STANDARD_ERROR_OF_MEAN|0.396||0.0122|TWO_SIDED|95.0|-1.77|-0.22||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 12||-0.22|-1.77|0.0122
71043454|NCT02418455|141596090|SUPERIORITY||LS Mean|-1.21|STANDARD_ERROR_OF_MEAN|0.461||0.0086|TWO_SIDED|95.0|-2.12|-0.31||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 24||-0.31|-2.12|0.0086
71043455|NCT02418455|141596090|SUPERIORITY||LS Mean|-0.98|STANDARD_ERROR_OF_MEAN|0.31||0.0016|TWO_SIDED|95.0|-1.58|-0.37||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 48||-0.37|-1.58|0.0016
71043456|NCT02418455|141596090|SUPERIORITY||LS Mean|-0.57|STANDARD_ERROR_OF_MEAN|0.428||0.1792|TWO_SIDED|95.0|-1.41|0.26||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 96||0.26|-1.41|0.1792
71003627|NCT06048809|141515019|OTHER|||||||0.01955327|||||||ANCOM-BC2|||Haemophilus haemolyticus: Change From Baseline at Week 6||||0.01955327
71043457|NCT02418455|141596090|SUPERIORITY||LS Mean|-0.35|STANDARD_ERROR_OF_MEAN|0.255||0.1731|TWO_SIDED|95.0|-0.85|0.15||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 144||0.15|-0.85|0.1731
71003628|NCT06048809|141515019|OTHER|||||||0.01995277|||||||ANCOM-BC2|||Neisseria mucosa: Change From Baseline at Week 6||||0.01995277
71043458|NCT02418455|141596091|SUPERIORITY||LS Mean|-0.37|STANDARD_ERROR_OF_MEAN|0.213||0.0843|TWO_SIDED|95.0|-0.78|0.05||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 12||0.05|-0.78|0.0843
71043459|NCT02418455|141596091|SUPERIORITY||LS Mean|-0.02|STANDARD_ERROR_OF_MEAN|0.513||0.9618|TWO_SIDED|95.0|-1.03|0.98||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 24||0.98|-1.03|0.9618
71003629|NCT06048809|141515019|OTHER|||||||0.02082528|||||||ANCOM-BC2|||Parvimonas sp.\_HMT\_393\_nov\_97.053%: Change From Baseline at Week 6||||0.02082528
71003630|NCT06048809|141515019|OTHER|||||||0.02188156|||||||ANCOM-BC2|||Ottowia sp.\_HMT\_894: Change from Baseline at Week 6||||0.02188156
71003631|NCT06048809|141515019|OTHER|||||||0.02321733|||||||ANCOM-BC2|||Cryptobacterium curtum: Change From Baseline at Week 6||||0.02321733
71043460|NCT02418455|141596091|SUPERIORITY||LS Mean|-0.15|STANDARD_ERROR_OF_MEAN|0.391||0.6954|TWO_SIDED|95.0|-0.92|0.61||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|GEE model|||Change at Week 48||0.61|-0.92|0.6954
71043461|NCT02418455|141596091|SUPERIORITY||LS Mean|0.22|STANDARD_ERROR_OF_MEAN|0.364||0.5492|TWO_SIDED|95.0|-0.5|0.93||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 96||0.93|-0.50|0.5492
71003632|NCT06048809|141515019|OTHER|||||||0.02397996|||||||ANCOM-BC2|||Lautropia mirabilis: Change from Baseline at Week 6||||0.02397996
71043462|NCT02418455|141596091|SUPERIORITY||LS Mean|-0.56|STANDARD_ERROR_OF_MEAN|0.503||0.2618|TWO_SIDED|95.0|-1.55|0.42||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 144||0.42|-1.55|0.2618
71043463|NCT02973321|141596092|OTHER|The overall Type 1 error for multiple comparisons of the HbA1c and body weight was controlled by a Hierarchical testing procedure. Testing was performed in following sequence: 1. 1st trend test for HbA1c, 2. 1st trend test for body weight, 3. 2nd trend test for HbA1c, 4. 2nd trend test for body weight, 5. 3rd trend test for HbA1c, 6. 3rd trend test for body weight.|||||<|0.0001||||||Hierarchical testing procedure continued only, if the previous comparison was statistically significant. Threshold for significance at 0.05 level.|ANCOVA|1st trend test||Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of screening HbA1c value (\<8, \>=8 %), randomization strata of Visit 4 (Day 1) BMI (\<35.0 kg/m\^2, \>=35.0 kg/m\^2), and country as fixed effects and baseline HbA1c as a covariate. Overall 1st trend test based on a contrast with coefficients of +3, +1, -1, -3 and 0 for SAR425899 0.20 mg, 0.16 mg, 0.12 mg, placebo and liraglutide. Here it is test 1 of testing order.||||< 0.0001
71101132|NCT03533491|141710319|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|0.066|STANDARD_ERROR_OF_MEAN|0.111||0.551|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.551
71101133|NCT03533491|141710320|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|-0.158|STANDARD_ERROR_OF_MEAN|0.255||0.255|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.255
71003633|NCT06048809|141515019|OTHER|||||||0.02509094|||||||ANCOM-BC2|||Haemophilus paraphrohaemolyticus: Change From Baseline at Week 6||||0.02509094
71003634|NCT06048809|141515019|OTHER|||||||0.02648847|||||||ANCOM-BC2|||Capnocytophaga sp.\_HMT\_332: Change From Baseline at Week 6||||0.02648847
71003635|NCT06048809|141515019|OTHER|||||||0.02828764|||||||ANCOM-BC2|||Neisseria flavescens: Change From Baseline at Week 6||||0.02828764
71003636|NCT06048809|141515019|OTHER|||||||0.03454372|||||||ANCOM-BC2|||Capnocytophaga gingivalis\_nov\_96.429%: Change From Baseline at Week 6||||0.03454372
71003637|NCT06048809|141515019|OTHER|||||||0.03747507|||||||ANCOM-BC2|||Capnocytophaga sputigena: Change From Baseline at Week 6||||0.03747507
71003638|NCT06048809|141515019|OTHER|||||||0.03776136|||||||ANCOM-BC2|||Haemophilus sputorum: Change From Baseline at Week 6||||0.03776136
71003639|NCT06048809|141515019|OTHER|||||||0.03853215|||||||ANCOM-BC2|||Capnocytophaga gingivalis\_nov\_90.546%: Change From Baseline at Week 6||||0.03853215
71003640|NCT06048809|141515019|OTHER|||||||0.04751303|||||||ANCOM-BC2|||Prevotella denticola: Change From Baseline at Week 6||||0.04751303
71003641|NCT06048809|141515019|OTHER|||||||0.05190512|||||||ANCOM-BC2|||Aggregatibacter sp.\_HMT\_513: Change From Baseline at Week 6||||0.05190512
71003642|NCT06048809|141515019|OTHER|||||||0.0550647|||||||ANCOM-BC2|||Veillonella sp.\_HMT\_780: Change From Baseline at Week 6||||0.0550647
71101134|NCT03533491|141710321|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.142|||TWO_SIDED|||||||A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||
71003643|NCT06048809|141515019|OTHER|||||||0.05861488|||||||ANCOM-BC2|||Neisseria perflava: Change From Baseline at Week 6||||0.05861488
71003644|NCT06048809|141515019|OTHER|||||||0.06727926|||||||ANCOM-BC2|||Slackia exigua: Change From Baseline at Week 6||||0.06727926
71003645|NCT06048809|141515019|OTHER|||||||0.07051698|||||||ANCOM-BC2|||Shuttleworthia satelles: Change from Baseline at Week 6||||0.07051698
71003646|NCT06048809|141515019|OTHER|||||||0.0740793|||||||ANCOM-BC2|||Aggregatibacter sp.\_HMT\_458: Change From Baseline at Week 6||||0.0740793
71003647|NCT06048809|141515019|OTHER|||||||0.07426973|||||||ANCOM-BC2|||Ruminococcaceae\_\[G-1\] bacterium\_HMT\_075: Change From Baseline at Week 6||||0.07426973
71003648|NCT06048809|141515019|OTHER|||||||0.07829888|||||||ANCOM-BC2|||Campylobacter showae: Change From Baseline at Week 6||||0.07829888
71003649|NCT06048809|141515019|OTHER|||||||0.08462924|||||||ANCOM-BC2|||Streptococcus sp.\_HMT\_056: Change From Baseline at Week 6||||0.08462924
71003650|NCT06048809|141515020|OTHER|||||||0.062378|||||||ANCOM-BC2|||Abiotrophia defectiva: Change from Baseline at Week 6||||0.062378
71003651|NCT06048809|141515020|OTHER|||||||0.063437|||||||ANCOM-BC2|||Saccharibacteria\_(TM7)\_\[G1\] bacterium\_HMT\_346: Change from Baseline at Week 6||||0.063437
71003652|NCT06048809|141515020|OTHER|||||||0.069908|||||||ANCOM-BC2|||Olsenella sp.\_HMT\_807: Change from Baseline at Week 6||||0.069908
71003653|NCT06048809|141515020|OTHER|||||||0.079736|||||||ANCOM-BC2|||Fusobacterium nucleatum\_nucleatum\_subsp.\_animalis: Change from Baseline at Week 6||||0.079736
71003654|NCT06048809|141515020|OTHER|||||||0.094642|||||||ANCOM-BC2|||Bergeyella sp.\_HMT\_322: Change from Baseline at Week 6||||0.094642
71003655|NCT06048809|141515020|OTHER|||||||0.095848|||||||ANCOM-BC2|||Peptostreptococcaceae\_\[XI\]\[G-1\] \[Eubacterium\]\_infirmum: Change from Baseline at Week 6||||0.095848
71003656|NCT06048809|141515020|OTHER|||||||0.107931|||||||ANCOM-BC2|||Prevotella sp.\_HMT\_317: Change from Baseline at Week 6||||0.107931
71003657|NCT06048809|141515020|OTHER|||||||0.109114|||||||ANCOM-BC2|||Bacteroidales\_\[G-2\] bacterium\_HMT\_274: Change from Baseline at Week 6||||0.109114
71003658|NCT06048809|141515020|OTHER|||||||0.11083|||||||ANCOM-BC2|||Actinomyces sp.\_HMT\_175\_nov 97.951%: Change from Baseline at Week 6||||0.11083
71003659|NCT06048809|141515020|OTHER|||||||0.120377|||||||ANCOM-BC2|||Slackia exigua: Change from Baseline at Week 6||||0.120377
71101135|NCT03533491|141710322|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|-0.119|STANDARD_ERROR_OF_MEAN|0.091||0.198|TWO_SIDED||||||t-test, 2 sided|||||||.198
71003660|NCT06048809|141515020|OTHER|||||||0.123758|||||||ANCOM-BC2|||Granulicatella adiacens: Change from Baseline at Week 6||||0.123758
71003661|NCT06048809|141515020|OTHER|||||||0.123992|||||||ANCOM-BC2|||Prevotella oris: Change from Baseline at Week 6||||0.123992
71003662|NCT06048809|141515020|OTHER|||||||0.133385|||||||ANCOM-BC2|||Streptococcus sp.\_HMT\_064: Change from Baseline at Week 6||||0.133385
71003663|NCT06048809|141515020|OTHER|||||||0.144598|||||||ANCOM-BC2|||Schaalia odontolyticus: Change from Baseline at Week 6||||0.144598
71043464|NCT02973321|141596092|OTHER|Hierarchical testing procedure continued only, if the previous comparison was statistically significant.|LS Mean difference|-0.956|STANDARD_ERROR_OF_MEAN|0.206|<|0.0001|TWO_SIDED|95.0|-1.359|-0.552||Threshold for significance at 0.05 level.|ANCOVA|2nd Trend test||Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c value (\<8, \>=8 %), randomization strata of Visit 4 (Day 1) BMI (\<35.0 kg/m\^2, \>=35.0 kg/m\^2), and country as fixed effects and baseline HbA1c as a covariate. Second Trend test based on a contrast with coefficients of 0, +1, 0, -1 and 0 for SAR425899 0.20 mg, 0.16 mg, 0.12 mg, placebo and liraglutide, respectively. Here, it is test no. 3 of hierarchical testing sequence.||-0.552|-1.359|< 0.0001
71043465|NCT02973321|141596092|OTHER|Hierarchical testing procedure continued only, if the previous comparison was statistically significant.|LS Mean difference|-0.854|STANDARD_ERROR_OF_MEAN|0.209|<|0.0001|TWO_SIDED|95.0|-1.264|-0.444||Threshold for significance at 0.05 level.|ANCOVA|3rd Trend test||Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c value (\<8, \>=8 %), randomization strata of Visit 4 (Day 1) BMI (\<35.0 kg/m\^2, \>=35.0 kg/m\^2), and country as fixed effects and baseline HbA1c as a covariate. Third Trend test based on a contrast with coefficients of 0, 0, +1, -1 and 0 for SAR425899 0.20 mg, 0.16 mg, 0.12 mg, placebo and liraglutide, respectively. Here, it is test no. 5 of hierarchical testing sequence.||-0.444|-1.264|< 0.0001
71043466|NCT02973321|141596093|OTHER|Hierarchical testing procedure continued only, if the previous comparison was statistically significant.||||||0.0012||||||Threshold for significance at 0.05 level.|ANCOVA|1st Trend test||Placebo, SAR425899 0.12,0.16,0.20 mg: Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c value (\<8, \>=8 %), randomization strata of Day 1 BMI (\<35.0 kg/m\^2, \>=35.0 kg/m\^2), and country as fixed effects and baseline body weight as a covariate. Here, it is test no. 2 of hierarchical testing sequence.||||0.0012
71043467|NCT02973321|141596093|OTHER|Hierarchical testing procedure continued only, if the previous comparison was statistically significant|LS Mean difference|-3.57|STANDARD_ERROR_OF_MEAN|0.887|<|0.0001|TWO_SIDED|95.0|-5.309|-1.832||Threshold for significance at 0.05 level.|ANCOVA|2nd Trend test||SAR425899 0.16 mg vs Placebo: Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c value (\<8, \>=8 %), randomization strata of Day 1 BMI (\<35.0 kg/m\^2, \>=35.0 kg/m\^2), and country as fixed effects and baseline body weight as a covariate. Here, it is test no. 4 of hierarchical testing sequence.||-1.832|-5.309|< 0.0001
71101136|NCT03533491|141710323|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|-0.035|STANDARD_ERROR_OF_MEAN|0.121||0.77|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.770
71101137|NCT03533491|141710324|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|-0.029|STANDARD_ERROR_OF_MEAN|0.137||0.834|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.834
71101138|NCT03533491|141710325|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|-0.096|STANDARD_ERROR_OF_MEAN|0.07||0.175|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.175
71101139|NCT01725282|141710338|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|0.2|STANDARD_ERROR_OF_MEAN|1.7|||TWO_SIDED|95.0|-3.1|3.6|||||An analysis of covariance model with the baseline as a covariate and treatment group as a fixed effect.|||3.6|-3.1|
71101140|NCT01725282|141710338|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|1.7|||TWO_SIDED|95.0|-4.0|2.8|||||An analysis of covariance model with the baseline as a covariate and treatment group as a fixed effect.|||2.8|-4.0|
70924651|NCT04321031|141342040|SUPERIORITY||LS Mean|-69.27|||||TWO_SIDED|90.0|-81.08|-50.07||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-50.07|-81.08|
71003664|NCT06048809|141515020|OTHER|||||||0.147278|||||||ANCOM-BC2|||Mogibacterium diversum: Change from Baseline at Week 6||||0.147278
71101141|NCT01725282|141710338|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|1.3|STANDARD_ERROR_OF_MEAN|1.7|||TWO_SIDED|95.0|-2.1|4.6|||||An analysis of covariance model with the baseline as a covariate and treatment group as a fixed effect.|||4.6|-2.1|
71101142|NCT04576481|141710349|SUPERIORITY||F-Statistic|1.18||||0.32|TWO_SIDED||||||ANOVA|||Analysis of Variance statistical testing.||||0.32
71003665|NCT06048809|141515020|OTHER|||||||0.148674|||||||ANCOM-BC2|||Prevotella denticola: Change from Baseline at Week 6||||0.148674
71101143|NCT04576481|141710350|SUPERIORITY||F-Statistic|0.25||||0.78|TWO_SIDED||||||ANOVA|||||||0.78
71101144|NCT04576481|141710351|SUPERIORITY|||||||0.19|||||||ANOVA|||||||0.19
71101145|NCT04576481|141710352|SUPERIORITY|||||||0.46|||||||ANOVA|||||||0.46
71101146|NCT04576481|141710353|SUPERIORITY|||||||0.3|||||||ANOVA|||||||0.30
71101147|NCT05263791|141710354|NON_INFERIORITY|The primary objective to prove the non-inferiority in between the Airmod and reference device is determined by the difference between AirRR and ManCRR.|||||<|0.001|||||||Paired t Test|||Hypothesis: airRR-mancRR ≦ -3, In the target of p\<0.05 indicates significance.||||<0.001
71003666|NCT06048809|141515020|OTHER|||||||0.149722|||||||ANCOM-BC2|||Absconditabacteria\_(SR1)\_\[G-1\] bacterium\_HMT\_875: Change from Baseline at Week 6||||0.149722
71003667|NCT06048809|141515020|OTHER|||||||0.154465|||||||ANCOM-BC2|||Prevotella nigrescens: Change from Baseline at Week 6||||0.154465
71003668|NCT06048809|141515020|OTHER|||||||0.158139|||||||ANCOM-BC2|||Streptococcus chosunense: Change from Baseline at Week 6||||0.158139
71003669|NCT00554853|141515024|SUPERIORITY_OR_OTHER|||||||0.63|||||||ANCOVA|||||||0.63
71003670|NCT02148952|141515028|SUPERIORITY|We hypothesized a 15% reduction in the composite outcome between the intervention and control arm.|Risk Ratio (RR)|0.99||||0.9|TWO_SIDED|95.0|0.83|1.18|||Chi-squared, Corrected|In secondary analyses, a Rao-Scott test with 3 degrees of freedom resulted in a p value of 0.88.|Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.18|0.83|0.90
71003671|NCT02148952|141515029|SUPERIORITY||Risk Ratio (RR)|1.03||||0.67|TWO_SIDED|95.0|0.89|1.2|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.20|0.89|0.67
71003672|NCT02148952|141515030|SUPERIORITY||Risk Ratio (RR)|1.03||||0.68|TWO_SIDED|95.0|0.89|1.2|||Chi-squared, Corrected|||||1.20|0.89|0.68
71003673|NCT02148952|141515031|SUPERIORITY||Risk Ratio (RR)|0.94||||0.56|TWO_SIDED|95.0|0.76|1.16|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.16|0.76|0.56
71003674|NCT02148952|141515032|SUPERIORITY||Risk Ratio (RR)|1.1||||0.19|TWO_SIDED|95.0|0.95|1.27|||Chi-squared, Corrected|||||1.27|0.95|0.19
71003675|NCT02148952|141515033|SUPERIORITY||Risk Ratio (RR)|1.11||||0.73|TWO_SIDED|95.0|0.74|1.53|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.53|0.74|0.73
71003676|NCT02148952|141515034|SUPERIORITY||Risk Ratio (RR)|0.97||||0.81|TWO_SIDED|95.0|0.79|1.2|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate any severe maternal complication within 7 days||1.20|0.79|0.81
71003677|NCT02148952|141515034|SUPERIORITY||Risk Ratio (RR)|0.89||||0.76|TWO_SIDED|95.0|0.57|1.52|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate of seizures||1.52|0.57|0.76
71003678|NCT02148952|141515034|SUPERIORITY||Risk Ratio (RR)|0.98||||0.97|TWO_SIDED|95.0|0.7|1.41|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate of loss of consciousness for \> 1 hr||1.41|0.70|0.97
71043468|NCT02973321|141596093|OTHER|Hierarchical testing procedure continued only, if the previous comparison was statistically significant.|LS Mean difference|-2.517|STANDARD_ERROR_OF_MEAN|0.891||0.0047|TWO_SIDED|95.0|-4.264|-0.77||Threshold for significance at 0.05 level.|ANCOVA|3rd Trend test||3rd Trend Test: SAR425899 0.12 mg vs Placebo: Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c value (\<8, \>=8 %), randomization strata of Day 1 BMI (\<35.0 kg/m\^2, \>=35.0 kg/m\^2), and country as fixed effects and baseline body weight as a covariate. Here, it is test no. 6 of hierarchical testing sequence.||-0.77|-4.264|0.0047
71043469|NCT01557920|141596149|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||pathological swallows under anesthesia vs. wakefulness: 25.9% vs. 4.9%|Mixed Models Analysis|||||||0.001
71043470|NCT01557920|141596149|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Comparison of pathological swallow-rate increase by carbon-dioxide during anesthesia and wakefulness||||<0.001
71101148|NCT05263791|141710355|NON_INFERIORITY|The hypothesis tested is demonstrated airRR non-inferior to acoRR when the capnostream is less sensitive.|||||<|0.001|||||||Paired t Test|||"In this study, a non-inferiority test was conducted during periods of reduced sensitivity in capnography to compare respiratory rate measurements using the Airmod device (airRR) versus manually scored auscultation sounds (referred to as acoRR, implying manARR in the statistical analysis plan). The research physician identified periods of reduced sensitivity in capnography."||||<0.001
71003679|NCT02148952|141515034|SUPERIORITY||Risk Ratio (RR)|1.02||||0.9|TWO_SIDED|95.0|0.76|1.38|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate of high fever with foul-smelling vaginal discharge||1.38|0.76|0.90
71003680|NCT02148952|141515034|SUPERIORITY||Risk Ratio (RR)|0.95||||0.61|TWO_SIDED|95.0|0.77|1.17|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate of hemorrhage||1.17|0.77|0.61
71003681|NCT02148952|141515034|SUPERIORITY||Risk Ratio (RR)|0.5||||0.41|TWO_SIDED|95.0|0.34|1.58|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate of stroke||1.58|0.34|0.41
71043471|NCT01557920|141596154|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The number of swallows per hour: 1.7±3.3 during anesthesia vs. 28.0±22.3 during wakefulness|Mixed Models Analysis|||||||<0.001
71101149|NCT05263791|141710357|SUPERIORITY|This analysis were examined to assess the responsiveness of Airmod and Capnography.|||||<|0.001|||||||Paired t Test|||The hypothesis tested whether the response times obtained with the Airmod device were equal to those recorded with Capnography.||||<0.001
71003682|NCT02148952|141515035|SUPERIORITY||Risk Ratio (RR)|1.07||||0.74|TWO_SIDED|95.0|0.72|1.58|||Chi-squared, Corrected|||||1.58|0.72|0.74
71003683|NCT02148952|141515036|SUPERIORITY||Risk Ratio (RR)|1.09||||0.57|TWO_SIDED|95.0|0.81|1.47|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.47|0.81|0.57
71101150|NCT05263791|141710358|NON_INFERIORITY|The objective to prove the non-inferiority in between the Airmod and reference device is determined by the difference between AirRR and ManCRR by subjects.|||||<|0.05|||||||Paired t Test|||Hypothesis: airRR-mancRR ≦ -2, In the target of p\<0.05 indicates significance.||||<0.05
71043472|NCT00346164|141596174|OTHER||||||<|0.0001|||||||Regression, Cox|||The Cox proportional hazards model was used to evaluate prognostic impact of disease extent (non-metastatic; metastatic) after accounting for the effects of site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (\<=5cm; \>5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), extent of resection of the primary tumor (less than total resection; margin -; margin +), and histologic (POG) grade.||||<0.0001
71043473|NCT00346164|141596175|OTHER|||||||0.0049|||||||Regression, Cox|||The Cox proportional hazards model was used to evaluate prognostic impact of histologic (POG) grade after accounting for the effects of disease extent (non-metastatic; metastatic), site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (\<=5cm; \>5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), and extent of resection of the primary tumor (less than total resection; margin -; margin +) .||||0.0049
71003684|NCT02148952|141515037|SUPERIORITY||Risk Ratio (RR)|1.19||||0.41|TWO_SIDED|95.0|0.78|1.8|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.80|0.78|0.41
71003685|NCT02148952|141515038|SUPERIORITY||Risk Ratio (RR)|1.0||||0.95|TWO_SIDED|95.0|0.45|2.13|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||2.13|0.45|0.95
71003686|NCT02148952|141515039|SUPERIORITY||Risk Ratio (RR)|0.99||||0.97|TWO_SIDED|95.0|0.69|1.43|||Chi-squared, Corrected|||||1.43|0.69|0.97
71003687|NCT02148952|141515040|SUPERIORITY||Risk Ratio (RR)|0.91||||0.32|TWO_SIDED|95.0|0.76|1.1|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.10|0.76|0.32
71003688|NCT02148952|141515041|SUPERIORITY||Risk Ratio (RR)|0.92||||0.3|TWO_SIDED|95.0|0.78|1.08|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.08|0.78|0.30
71003689|NCT02148952|141515042|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected|||||||<0.001
71003690|NCT02148952|141515043|SUPERIORITY||Other|0.0||||0.18|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Birth Companion Present||||0.18
71003691|NCT02148952|141515043|SUPERIORITY||Risk Ratio (RR)|9.8|||<|0.001|TWO_SIDED|95.0|3.4|28.3|||Chi-squared, Corrected|||Maternal blood pressure taken||28.3|3.4|<0.001
71003692|NCT02148952|141515043|SUPERIORITY||Risk Ratio (RR)|132.0|||<|0.001|TWO_SIDED|95.0|26.9|645.0|||Chi-squared, Corrected|||Maternal temperature taken||645|26.9|<0.001
71003693|NCT02148952|141515043|SUPERIORITY||Risk Ratio (RR)|7.3||||0.01|TWO_SIDED|95.0|1.5|35.6|||Chi-squared, Corrected|||Partography started||35.6|1.5|0.01
71043474|NCT00346164|141596176|OTHER||||||<|0.0001|||||||Regression, Cox|||The Cox proportional hazards model was used to evaluate prognostic impact of disease extent (non-metastatic; metastatic) after accounting for the effects of site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (\<=5cm; \>5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), extent of resection of the primary tumor (less than total resection; margin -; margin +), and histologic (POG) grade.||||<0.0001
71043475|NCT00346164|141596177|OTHER|||||||0.0096|||||||Regression, Cox|||The Cox proportional hazards model was used to evaluate prognostic impact of the resection extent of the primary tumor (less than total resection; margin -; margin +) after accounting for the effects of site of the primary tumor (body wall; extremity; head/neck; visceral), disease extent (non-metastatic; metastatic), tumor size (\<=5cm; \>5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), and histologic (POG) grade.||||0.0096
71043476|NCT00346164|141596178|OTHER||||||<|0.0001|||||||Regression, Logistic|Firth logistic regression is used to overcome the issue of quasi-complete separation of data points.||The logistic regression model was used to evaluate prognostic impact of disease extent (non-metastatic; metastatic) after accounting for the effects of site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (\<=5cm; \>5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), extent of resection of the primary tumor (less than total resection; margin -; margin +), and histologic (POG) grade.||||<0.0001
71043477|NCT00346164|141596179|OTHER|||||||0.0228|||||||Regression, Logistic|Firth logistic regression is used to overcome the issue of quasi-complete separation of data points.||The logistic regression model was used to evaluate prognostic impact of histologic (POG) grade after accounting for the effects of disease extent (non-metastatic; metastatic), site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (\<=5cm; \>5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), and extent of resection of the primary tumor (less than total resection; margin -; margin +) .||||0.0228
71043478|NCT00346164|141596181|OTHER||Kappa statistic|0.82|||||TWO_SIDED|95.0|0.76|0.88||||||Kappa statistic and its 95% confidence interval are used to assess agreement beyond random.||0.88|0.76|
71101151|NCT01946880|141710367|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.07|||||TWO_SIDED|95.0|-0.068|0.214||||||||0.214|-0.068|
71101152|NCT01946880|141710369|OTHER||Risk Difference (RD)|0.08|||||TWO_SIDED|95.0|-0.116|0.279||||||||0.279|-0.116|
71101153|NCT01946880|141710370|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.13|||||TWO_SIDED|95.0|-0.091|0.36||||||||0.360|-0.091|
71003694|NCT02148952|141515043|SUPERIORITY||Risk Ratio (RR)|413.0|||<|0.001|TWO_SIDED|95.0|65.8|2589.0|||Chi-squared, Corrected|||Checklist use||2589|65.8|<0.001
71003695|NCT02148952|141515044|SUPERIORITY||Risk Ratio (RR)|53.3|||<|0.001|TWO_SIDED|95.0|13.1|217.0|||Chi-squared, Corrected|||Hand hygiene||217|13.1|<0.001
71003696|NCT02148952|141515044|SUPERIORITY||Risk Ratio (RR)|2.3||||0.007|TWO_SIDED|95.0|1.3|4.2|||Chi-squared, Corrected|||No oxytocin given before delivery||4.2|1.3|0.007
71003697|NCT02148952|141515044|SUPERIORITY||Risk Ratio (RR)|5.7|||<|0.001|TWO_SIDED|95.0|2.7|12.1|||Chi-squared, Corrected|||Clean towel available||12.1|2.7|<0.001
71003698|NCT02148952|141515044|SUPERIORITY||Risk Ratio (RR)|1.1||||0.72|TWO_SIDED|95.0|0.7|1.7|||Chi-squared, Corrected|||Clean scissors or blade available||1.7|0.7|0.72
71003699|NCT02148952|141515044|SUPERIORITY||Risk Ratio (RR)|1.0||||0.48|TWO_SIDED|95.0|1.0|1.0|||Chi-squared, Corrected|||Cord tie available||1.0|1.0|0.48
71043479|NCT00346164|141596182|OTHER||Kappa statistic|0.42|||||TWO_SIDED|95.0|0.36|0.48||||||Kappa statistic and its 95% confidence interval are used to assess agreement beyond random.||0.48|0.36|
70924652|NCT04321031|141342040|SUPERIORITY||LS Mean|-21.8|||||TWO_SIDED|50.0|-34.02|-7.32||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-7.32|-34.02|
70924653|NCT04321031|141342040|SUPERIORITY||LS Mean|-21.8|||||TWO_SIDED|90.0|-48.51|18.76||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||18.76|-48.51|
71003700|NCT02148952|141515044|SUPERIORITY||Risk Ratio (RR)|1.0||||0.73|TWO_SIDED|95.0|0.9|1.1|||Chi-squared, Corrected|||Mucus extractor available||1.1|0.9|0.73
71003701|NCT02148952|141515044|SUPERIORITY||Risk Ratio (RR)|1.0||||0.56|TWO_SIDED|95.0|0.9|1.1|||Chi-squared, Corrected|||Neonatal bag and mask available||1.1|0.9|0.56
71003702|NCT02148952|141515044|SUPERIORITY||Risk Ratio (RR)|2.1||||0.005|TWO_SIDED|95.0|1.3|3.5|||Chi-squared, Corrected|||Pads available||3.5|1.3|0.005
71003703|NCT02148952|141515044|SUPERIORITY||Risk Ratio (RR)|185.0|||<|0.001|TWO_SIDED|95.0|19.7|1738.0|||Chi-squared, Corrected|||Checklist use||1738|19.7|<0.001
71043480|NCT01998243|141596206|SUPERIORITY||Risk Ratio (RR)|1.2||||0.689|TWO_SIDED|95.0|0.53|2.6|||Chi-squared||risk ratio (RR)|||2.60|0.53|0.689
71043481|NCT01998243|141596207|SUPERIORITY||Risk Ratio (RR)|1.59||||0.144|TWO_SIDED|95.0|0.84|3.01|||Chi-squared||all in all balloon and postsurgical morbidity in group A vs. group B.|||3.01|0.84|0.144
71043482|NCT01998243|141596208|SUPERIORITY|||||||0.937|||||||Wilcoxon (Mann-Whitney)|||||||0.937
71043483|NCT01998243|141596209|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
71043484|NCT01998243|141596210|SUPERIORITY|||||||0.673|||||||Fisher Exact|||||||0.673
71043485|NCT01056640|141596211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31|STANDARD_ERROR_OF_MEAN|0.2865||0.05|TWO_SIDED|95.0|0.747|2.297|||Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum test, 2-sample t-test and Chi-square analysis were all used.||All analyses were performed using an intent-to-treat method. Wilcoxon rank sum test, 2-sample t test, or Chi-Square analysis was used to compare baseline characteristics. The primary end points of combined and individual percentages of hospitalizations and ED visits were compared using Chi-Square test. Statistical adjustment was planned only if there were statistical differences in clinical variables between the groups. All tests for significance used a 2-sided P value of .05.||2.297|0.747|0.05
71043486|NCT04569786|141596217|SUPERIORITY|A conclusion of superiority is based on the lower limit of the 90% CI for the estimated GMT ratio (V590/Placebo) being \>1.0 (one-sided p-value \<0.05).|GMT Ratio|0.92||||0.649|TWO_SIDED|90.0|0.63|1.34||1-sided|Longitudinal data analysis (LDA) method|GMT ratios and 90% CIs, and p-values are estimated from an LDA model and are provided in accordance with the statistical analysis plan.||||1.34|0.63|0.649
70924654|NCT04321031|141342040|SUPERIORITY||LS Mean|-37.97|||||TWO_SIDED|50.0|-49.4|-23.95||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-23.95|-49.40|
70924655|NCT04321031|141342040|SUPERIORITY||LS Mean|-37.97|||||TWO_SIDED|90.0|-62.41|2.37||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||2.37|-62.41|
71003704|NCT02148952|141515045|SUPERIORITY||Risk Ratio (RR)|3.9|||<|0.001|TWO_SIDED|95.0|2.1|7.2|||Chi-squared, Corrected|||Oxytocin administered||7.2|2.1|<0.001
71003705|NCT02148952|141515045|SUPERIORITY||Risk Ratio (RR)|0.6||||0.25|TWO_SIDED|95.0|0.3|1.4|||Chi-squared, Corrected|||Neonatal bag used||1.4|0.3|0.25
71003706|NCT02148952|141515045|SUPERIORITY||Risk Ratio (RR)|1.0||||0.25|TWO_SIDED|95.0|1.0|1.0|||Chi-squared, Corrected|||Birth attendant present||1.0|1.0|0.25
71003707|NCT02148952|141515046|SUPERIORITY||Risk Ratio (RR)|1.1||||0.25|TWO_SIDED|95.0|0.9|1.4|||Chi-squared, Corrected|||Newborn weight taken||1.4|0.9|0.25
71003708|NCT02148952|141515046|SUPERIORITY||Risk Ratio (RR)|317.0|||<|0.001|TWO_SIDED|95.0|50.4|1989.0|||Chi-squared, Corrected|||Newborn temperature taken||1989|50.4|<0.001
71003709|NCT02148952|141515046|SUPERIORITY||Risk Ratio (RR)|7.3|||<|0.001|TWO_SIDED|95.0|2.4|22.0|||Chi-squared, Corrected|||Skin-to-skin care initiated at birth||22.0|2.4|<0.001
71043487|NCT04569786|141596217|SUPERIORITY|A conclusion of superiority is based on the lower limit of the 90% CI for the estimated GMT ratio (V590/Placebo) being \>1.0 (one-sided p-value \<0.05).|GMT Ratio|1.0||||0.495||90.0|0.68|1.48||1-sided|LDA model|GMT ratios and 90% CIs, and p-values are estimated from an LDA model and are provided in accordance with the statistical analysis plan.||||1.48|0.68|0.495
71043488|NCT04569786|141596217|SUPERIORITY|A conclusion of superiority is based on the lower limit of the 90% CI for the estimated GMT ratio (V590/Placebo) being \>1.0 (one-sided p-value \<0.05).|GMT Ratio|1.1||||0.339|TWO_SIDED|90.0|0.75|1.6||1-sided|LDA Model|GMT ratios and 90% CIs, and p-values are estimated from an LDA model and are provided in accordance with the statistical analysis plan.||||1.60|0.75|0.339
71043489|NCT04569786|141596217|SUPERIORITY|A conclusion of superiority is based on the lower limit of the 90% CI for the estimated GMT ratio (V590/Placebo) being \>1.0 (one-sided p-value \<0.05).|GMT Ratio|2.26|||<|0.001|TWO_SIDED|90.0|1.56|3.28||1-sided|LDA Model|GMT ratios and 90% CIs, and p-values are estimated from an LDA model and are provided in accordance with the statistical analysis plan.||||3.28|1.56|<0.001
71043490|NCT02563769|141596263|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
71043491|NCT02563769|141596263|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
71043492|NCT00925301|141596290|SUPERIORITY||Difference|12.5||||0.2996|TWO_SIDED|95.0|-13.4|37.3|||Cochran-Mantel-Haenszel|p-value from Cochran-Mantel-Haenszel test stratified by sex|The difference between the percentage of successes between migalastat and placebo treatment groups|||37.3|-13.4|0.2996
71043493|NCT00925301|141596293|OTHER|Mixed effects model for repeated measures (MMRM) approach with fixed effects of treatment, time (Month 6 and Month 12), mutation type (amenable or non-amenable), time by treatment interaction, time by mutation type interaction, and the baseline value as a covariate. An unstructured covariance matrix to account for repeated measures within a participant was assumed.||||||0.014||||||Significant at the 0.050 level|MMRM|||||||0.014
71043494|NCT00925301|141596294|OTHER||Difference LSMeans|-0.3||||0.0078|TWO_SIDED|95.0|-0.6|-0.1||Significant at the 0.010 level|ANCOVA|||The change from Baseline in the average number of kidney ICs was analyzed using an ANCOVA model with covariate adjustment for the baseline value and factors for treatment group and the treatment by baseline interaction.||-0.1|-0.6|0.0078
71003710|NCT02148952|141515046|SUPERIORITY||Risk Ratio (RR)|38.7|||<|0.001|TWO_SIDED|95.0|7.7|194.0|||Chi-squared, Corrected|||Skin-to-skin care maintained for 1 hr||194|7.7|<0.001
71003711|NCT02148952|141515046|SUPERIORITY||Risk Ratio (RR)|19.4|||<|0.001|TWO_SIDED|95.0|11.4|33.2|||Chi-squared, Corrected|||Initiation of breast-feeding||33.2|11.4|<0.001
71003712|NCT02148952|141515046|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Checklist use||||<0.001
71003713|NCT02148952|141515047|SUPERIORITY||Risk Ratio (RR)|182.0|||<|0.001|TWO_SIDED|95.0|33.5|993.0|||Chi-squared, Corrected|||Maternal temperature taken||993|33.5|<0.001
71003714|NCT02148952|141515047|SUPERIORITY||Risk Ratio (RR)|9.9|||<|0.001|TWO_SIDED|95.0|3.8|25.8|||Chi-squared, Corrected|||Maternal blood pressure taken||25.8|3.8|<0.001
71003715|NCT02148952|141515047|SUPERIORITY||Risk Ratio (RR)|0.4||||0.3|TWO_SIDED|95.0|0.1|2.1|||Chi-squared, Corrected|||Mother given magnesium sulfate||2.1|0.1|0.30
71043495|NCT04117945|141596298|SUPERIORITY|||||||0.8874|||||||One-sided unstratified log-rank|||||||0.8874
71043496|NCT04117945|141596299|SUPERIORITY|||||||0.9683|||||||One-sided unstratified log-rank|||||||0.9683
71043497|NCT04117945|141596300|SUPERIORITY|||||||0.0448|||||||One-sided unstratified log-rank|||||||0.0448
71043498|NCT04117945|141596301|SUPERIORITY|||||||0.9007|||||||One-sided unstratified log-rank|||||||0.9007
71043499|NCT01917968|141596308|SUPERIORITY||Adjusted difference in percentages|6.5||||0.056|TWO_SIDED|90.0|-0.2|13.2||Statistical significance is considered at 0.05 level.|Z statistics|P-value is calculated using a Z statistics from the propensity score adjusted estimates. Missing values are handled using multiple imputation.||||13.2|-0.2|0.056
71043500|NCT01917968|141596309|NON_INFERIORITY|With type I error of 0.05 and type II error of 0.20 (power 80%), 298 subjects (149 subjects per arm) are needed to detect non-inferiority with a margin of 10%.|Adjusted difference in percentages|-0.4|||||TWO_SIDED|90.0|-2.7|1.9|||||The propensity score adjusted difference in SAE rate of Uphold LITE transvaginal mesh (TVM) vs. NTR was estimated.|||1.9|-2.7|
71043501|NCT03200535|141596338|SUPERIORITY|Superiority analysis|||||<|0.001|||||||Chi-squared|||||||<0.001
71101154|NCT01946880|141710371|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|-0.07|||||TWO_SIDED|95.0|-0.475|0.333||||||||0.333|-0.475|
71101155|NCT01946880|141710372|OTHER||Risk Difference (RD)|-0.02|||||TWO_SIDED|95.0|-0.286|0.249||||||The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.||0.249|-0.286|
71101156|NCT01946880|141710373|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.2|||||TWO_SIDED|95.0|-0.09|0.497||||||||0.497|-0.090|
71003716|NCT02148952|141515048|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected|||||||<0.001
71003717|NCT02148952|141515049|SUPERIORITY||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|1.0|1.0|||Chi-squared, Corrected|||Birth companion present||1.0|1.0|1.00
71003718|NCT02148952|141515049|SUPERIORITY||Risk Ratio (RR)|19.1|||<|0.001|TWO_SIDED|95.0|7.9|46.5|||Chi-squared, Corrected|||Maternal blood pressure taken||46.5|7.9|<0.001
71043502|NCT03200535|141596339|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71043503|NCT03078478|141596353|SUPERIORITY||Treatment rate ratio|0.88||||0.1715|TWO_SIDED|95.0|0.73|1.06|||Regression, Cox|||The number of episodes is analysed using a negative binomial regression model (log link) with the logarithm of the time period in which a hypoglycaemic episode was considered treatment emergent as offset. The model includes treatment, number of OADs, region, sex and dosing time as fixed factors, and age as a covariate. Missing values are imputed through multiple imputation by treatment arm, based on a Poisson model.||1.06|0.73|0.1715
71043504|NCT02339090|141596370|NON_INFERIORITY|Threshold for significance: annualized height velocity between somavaratan and daily rhGH ≤ -2.0 cm/year|LS Mean Difference|-1.28|||||TWO_SIDED|95.0|-2.32|-0.24||||||An ANCOVA model will be used to determine the adjusted (least squares) means and standard error (SE) to determine the confidence interval (CI) of the difference. ANCOVA model included treatment group, region, and gender as fixed effects; with baseline age and baseline IGF-I SDS as covariates.||-0.24|-2.32|
71043505|NCT04243096|141596379|OTHER||Mean Difference (Final Values)|4.62|||<|0.0001|TWO_SIDED|95.0|2.6|6.64|||Mixed Models Analysis|||||6.64|2.60|<0.0001
71043506|NCT04243096|141596380|OTHER||Mean Difference (Final Values)|-0.04|||<|0.0001|TWO_SIDED|95.0|-0.06|-0.02|||Mixed Models Analysis|||||-0.02|-0.06|<0.0001
71043507|NCT04243096|141596381|OTHER||Mean Difference (Final Values)|-0.02|||<|0.0001|TWO_SIDED|95.0|-0.03|-0.01|||Mixed Models Analysis|||||-0.01|-0.03|<0.0001
71043508|NCT04243096|141596382|OTHER||Mean Difference (Final Values)|-0.03|||<|0.0001|TWO_SIDED|95.0|-0.04|-0.02|||Mixed Models Analysis|||||-0.02|-0.04|<0.0001
71043509|NCT04243096|141596383|OTHER||Mean Difference (Final Values)|-0.01|||<|0.0001|TWO_SIDED|95.0|-0.01|0.0|||Mixed Models Analysis|||||0.00|-0.01|<0.0001
71043510|NCT04243096|141596384|OTHER||Mean Difference (Final Values)|-0.01||||0.0013|TWO_SIDED|95.0|-0.02|-0.01|||Mixed Models Analysis|||||-0.01|-0.02|0.0013
71043511|NCT04243096|141596385|OTHER||Mean Difference (Final Values)|-0.02||||0.0003|TWO_SIDED|95.0|-0.02|-0.01|||Mixed Models Analysis|||||-0.01|-0.02|0.0003
71043512|NCT04243096|141596386|OTHER||Mean Difference (Final Values)|0.03|||<|0.0001|TWO_SIDED|95.0|0.02|0.04|||Mixed Models Analysis|||||0.04|0.02|<0.0001
71043513|NCT04243096|141596387|OTHER||Mean Difference (Final Values)|0.09|||<|0.0001|TWO_SIDED|95.0|0.06|0.13|||Mixed Models Analysis|||||0.13|0.06|<0.0001
71003719|NCT02148952|141515049|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated due to 100% or 0% values in one group.|Maternal temperature taken||||<0.001
71003720|NCT02148952|141515049|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Partography started||||<0.001
71003721|NCT02148952|141515049|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Checklist use||||<0.001
71003722|NCT02148952|141515050|SUPERIORITY||Risk Ratio (RR)|19.9|||<|0.001|TWO_SIDED|95.0|6.6|60.4|||Chi-squared, Corrected|||Hand hygiene||60.4|6.6|<0.001
71003723|NCT02148952|141515050|SUPERIORITY||Risk Ratio (RR)|2.1||||0.04|TWO_SIDED|95.0|1.0|4.1|||Chi-squared, Corrected|||No oxytocin given before delivery||4.1|1.0|0.04
71003724|NCT02148952|141515050|SUPERIORITY||Risk Ratio (RR)|2.4||||0.006|TWO_SIDED|95.0|1.3|4.3|||Chi-squared, Corrected|||Clean towel available||4.3|1.3|0.006
71003725|NCT02148952|141515050|SUPERIORITY||Risk Ratio (RR)|1.0||||0.34|TWO_SIDED|95.0|1.0|1.1|||Chi-squared, Corrected|||Clean scissors or blade available||1.1|1.0|0.34
71003726|NCT02148952|141515050|SUPERIORITY||Risk Ratio (RR)|1.0||||0.25|TWO_SIDED|95.0|1.0|1.0|||Chi-squared, Corrected|||Cord tie available||1.0|1.0|0.25
71043514|NCT04243096|141596391|OTHER||Mean Difference (Final Values)|9.96|||<|0.0001|TWO_SIDED|95.0|6.6|13.31|||Mixed Models Analysis|||||13.31|6.60|<0.0001
71043515|NCT04243096|141596392|OTHER||Mean Difference (Final Values)|13.07|||<|0.0001|TWO_SIDED|95.0|9.65|16.48|||Mixed Models Analysis|adjusted for age, sex, BMI, and presence of comorbidities.|Change from baseline to week 12|||16.48|9.65|<0.0001
71043516|NCT04243096|141596393|OTHER||Median Difference (Final Values)|-17.5||||0.1196|TWO_SIDED|95.0|-39.7|4.61|||Mixed Models Analysis|||||4.61|-39.7|0.1196
71043517|NCT04243096|141596395|OTHER||Mean Difference (Final Values)|0.11|||<|0.0001|TWO_SIDED|95.0|-0.04|0.25|||Mixed Models Analysis|||||0.25|-0.04|<0.0001
71043518|NCT04243096|141596396|OTHER||Mean Difference (Final Values)|-1.83|||<|0.0001|TWO_SIDED|95.0|-5.76|2.09|||Mixed Models Analysis|||||2.09|-5.76|<0.0001
71043519|NCT04243096|141596397|OTHER||Mean Difference (Final Values)|-0.15|||<|0.0001|TWO_SIDED|95.0|-0.46|0.16|||Mixed Models Analysis|||||0.16|-0.46|<0.0001
71043520|NCT04243096|141596398|OTHER||Mean Difference (Final Values)|-1.15|||<|0.0001|TWO_SIDED|95.0|-2.22|-0.08|||Mixed Models Analysis|||||-0.08|-2.22|<0.0001
71101157|NCT01946880|141710374|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.08|||||TWO_SIDED|95.0|-0.056|0.211||||||||0.211|-0.056|
71101158|NCT01946880|141710375|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.12|||||TWO_SIDED|95.0|-0.041|0.284||||||||0.284|-0.041|
71003727|NCT02148952|141515050|SUPERIORITY||Risk Ratio (RR)|1.0||||0.5|TWO_SIDED|95.0|1.0|1.1|||Chi-squared, Corrected|||Mucus extractor available||1.1|1.0|0.50
71003728|NCT02148952|141515050|SUPERIORITY||Risk Ratio (RR)|1.0||||0.32|TWO_SIDED|95.0|1.0|1.0|||Chi-squared, Corrected|||Neonatal bag and mask available||1.0|1.0|0.32
71003729|NCT02148952|141515050|SUPERIORITY||Risk Ratio (RR)|1.4||||0.11|TWO_SIDED|95.0|0.9|2.1|||Chi-squared, Corrected|||Pads available||2.1|0.9|0.11
71043521|NCT04243096|141596399|OTHER||Mean Difference (Final Values)|-0.08|||<|0.0001|TWO_SIDED|95.0|-3.37|3.22|||Mixed Models Analysis|||||3.22|-3.37|<0.0001
71043522|NCT04243096|141596400|OTHER||Mean Difference (Final Values)|6.21||||0.0134|TWO_SIDED|95.0|1.31|11.11|||Mixed Models Analysis|||||11.11|1.31|0.0134
71101159|NCT01946880|141710376|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|-0.04|||||TWO_SIDED|95.0|-0.285|0.206||||||||0.206|-0.285|
71101160|NCT01946880|141710377|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.09|||||TWO_SIDED|95.0|-0.118|0.289||||||||0.289|-0.118|
71101161|NCT01946880|141710378|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.05|||||TWO_SIDED|95.0|-0.103|0.212||||||||0.212|-0.103|
71043523|NCT04243096|141596401|OTHER||Median Difference (Final Values)|1.75|||<|0.0001|TWO_SIDED|95.0|1.16|2.34|||Mixed Models Analysis|||||2.34|1.16|<0.0001
71043524|NCT04243096|141596402|OTHER||Median Difference (Final Values)|-1.19||||0.003|TWO_SIDED|95.0|-1.97|-0.41|||Mixed Models Analysis|||||-0.41|-1.97|0.0030
71043525|NCT04243096|141596403|OTHER||Mean Difference (Final Values)|0.45|||<|0.0001|TWO_SIDED|95.0|0.23|0.67|||Mixed Models Analysis|||||0.67|0.23|<0.0001
71043526|NCT04243096|141596404|OTHER||Mean Difference (Final Values)|35.18|||<|0.0001|TWO_SIDED|95.0|18.7|51.67|||Mixed Models Analysis|||||51.67|18.70|<0.0001
71043527|NCT04243096|141596405|OTHER||Mean Difference (Final Values)|-1.98|||<|0.0001|TWO_SIDED|95.0|-2.57|-1.39|||Mixed Models Analysis|||||-1.39|-2.57|<0.0001
71043528|NCT03581188|141596441|SUPERIORITY||Odds Ratio (OR)|3.5|||||TWO_SIDED|95.0|0.9|14.0||||||Odds ratios report differences between groups at follow-up.||14|0.9|
71043529|NCT03581188|141596442|SUPERIORITY||Odds Ratio (OR)|2.2|||||TWO_SIDED|95.0|0.8|5.7||||||||5.7|0.8|
71043530|NCT03581188|141596444|SUPERIORITY||Risk Ratio (RR)|1.5|||||TWO_SIDED|95.0|1.1|2.1||||||||2.1|1.1|
71043531|NCT03581188|141596445|SUPERIORITY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.6|2.0||||||||2|0.6|
71043532|NCT03581188|141596446|SUPERIORITY||Risk Difference (RD)|10.0|||||TWO_SIDED|95.0|-2.0|23.0||||||For new melanoma diagnoses, we calculated the difference in proportions and confidence intervals using the χ2 method without continuity correction. We included baseline measurement of the outcome in the models as a covariate to estimate between group difference in change from baseline.||23|-2|
71043533|NCT03581188|141596447|SUPERIORITY||Risk Difference (RD)|10.0|||||TWO_SIDED|95.0|2.0|19.0||||||New melanoma diagnoses prompted at unscheduled visit||19|2|
71101162|NCT01946880|141710381|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.06|||||TWO_SIDED|95.0|-0.028|0.149||||||||0.149|-0.028|
71003730|NCT02148952|141515050|SUPERIORITY||Risk Ratio (RR)|37.9|||<|0.001|TWO_SIDED|95.0|7.3|196.0|||Chi-squared, Corrected|||Checklist available||196|7.3|<0.001
71003731|NCT02148952|141515051|SUPERIORITY||Risk Ratio (RR)|3.6|||<|0.001|TWO_SIDED|95.0|1.8|7.5|||Chi-squared, Corrected|||Oxytocin administered||7.5|1.8|<0.001
71003732|NCT02148952|141515051|SUPERIORITY||Risk Ratio (RR)|0.6||||0.19|TWO_SIDED|95.0|0.3|1.3|||Chi-squared, Corrected|||Neonatal bag used||1.3|0.3|0.19
71003733|NCT02148952|141515051|SUPERIORITY||Risk Ratio (RR)|1.0||||0.5|TWO_SIDED|95.0|1.0|1.0|||Chi-squared, Corrected|||Birth companion present||1.0|1.0|0.50
71003734|NCT02148952|141515052|SUPERIORITY||Risk Ratio (RR)|1.1||||0.08|TWO_SIDED|95.0|1.0|1.3|||Chi-squared, Corrected|||Newborn weight taken||1.3|1.0|0.08
71003735|NCT02148952|141515052|SUPERIORITY||Risk Ratio (RR)|91.5|||<|0.001|TWO_SIDED|95.0|11.0|758.0|||Chi-squared, Corrected|||Newborn temperature taken||758|11.0|<0.001
71003736|NCT02148952|141515052|SUPERIORITY||Risk Ratio (RR)|8.2|||<|0.001|TWO_SIDED|95.0|2.5|27.5|||Chi-squared, Corrected|||Skin-to-skin care initiated at birth||27.5|2.5|<0.001
71003737|NCT02148952|141515052|SUPERIORITY||Other|0.0||||0.01|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Skin-to-skin care maintained for 1 hr||||0.01
71003738|NCT02148952|141515052|SUPERIORITY||Risk Ratio (RR)|7.9|||<|0.001|TWO_SIDED|95.0|3.7|16.7|||Chi-squared, Corrected|||Initiation of breast-feeding||16.7|3.7|<0.001
71003739|NCT02148952|141515052|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Checklist use||||<0.001
71003740|NCT02148952|141515053|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Maternal temperature taken||||<0.001
71003741|NCT02148952|141515053|SUPERIORITY||Risk Ratio (RR)|12.7|||<|0.001|TWO_SIDED|95.0|4.7|34.3|||Chi-squared, Corrected|||Maternal blood pressure taken||34.3|4.7|<0.001
71003742|NCT02148952|141515053|SUPERIORITY||Risk Ratio (RR)|1.1||||0.95|TWO_SIDED|95.0|0.2|6.6|||Chi-squared, Corrected|||Mother given magnesium sulfate||6.6|0.2|0.95
71003743|NCT01899768|141515095|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.26|||||TWO_SIDED|90.0|1.1|1.44|||||Ratio of adjusted geometric means = GSK2339345/Placebo.|||1.44|1.10|
71003744|NCT01899768|141515096|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.02|||||TWO_SIDED|90.0|0.87|1.19|||||Ratio of adjusted geometric means = GSK2339345/Placebo.|||1.19|0.87|
71003745|NCT01899768|141515119|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.23|||||TWO_SIDED|90.0|0.86|1.75|||||Ratio of adjusted geometric means = GSK2339345/Placebo. Estimated value and CI are presented for the mean cough count over 0-4 hr.|||1.75|0.86|
71003746|NCT01899768|141515119|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.36|||||TWO_SIDED|90.0|1.07|1.72|||||Ratio of adjusted geometric means = GSK2339345/Placebo. Estimated value and CI are presented for the mean cough count over 4-8 hr.|||1.72|1.07|
71101163|NCT01946880|141710382|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.06|||||TWO_SIDED|95.0|-0.02|0.134||||||||0.134|-0.020|
71003747|NCT01899768|141515120|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.97|||||TWO_SIDED|90.0|0.67|1.4|||||Ratio of adjusted geometric means = GSK2339345/Placebo. Estimated value and CI are presented for the mean cough count over 0-4 hr.|||1.40|0.67|
71003748|NCT01899768|141515120|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means = GSK2|1.04|||||TWO_SIDED|90.0|0.79|1.36|||Ratio of adjusted geometric mean|||||1.36|0.79|
71003749|NCT02203916|141515131|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.317|STANDARD_ERROR_OF_MEAN|2.4502|<|0.001|TWO_SIDED|95.0|-18.138|-8.497||"Overall type 1 error rate of 0.05 was controlled using principle of 'closed' testing: each pairwise comparison to placebo was conducted at 0.05 level with no p-value adjustment if hypothesis all treatment groups equal was first rejected at 0.05."|ANCOVA|Post-baseline p-values were from an ANCOVA model with treatment as a fixed factor and baseline values as a continuous covariate.||||-8.497|-18.138|<0.001
71003750|NCT02203916|141515131|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.955|STANDARD_ERROR_OF_MEAN|2.447|<|0.001|TWO_SIDED|95.0|-19.77|-10.141||"Overall type 1 error rate of 0.05 was controlled using principle of 'closed' testing: each pairwise comparison to placebo was conducted at 0.05 level with no p-value adjustment if hypothesis all treatment groups equal was first rejected at 0.05."|ANCOVA|Post-baseline p-values were from an ANCOVA model with treatment as a fixed factor and baseline values as a continuous covariate.||||-10.141|-19.770|<0.001
71003751|NCT00414973|141515153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.39|STANDARD_ERROR_OF_MEAN|0.76|<|0.0001||95.0|2.89|5.89||There were no adjustments for multiple comparisons.|ANCOVA||Difference = Teriparatide minus Calcitonin|Null hypothesis=no difference between percentage changes from baseline in lumbar spine bone mineral density for female patients receiving teriparatide compared to female patients receiving calcitonin.||5.89|2.89|<0.0001
71003752|NCT00414973|141515154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.7||0.9062||95.0|-1.3|1.46|||ANCOVA||Difference = Teriparatide minus Calcitonin|||1.46|-1.30|0.9062
71003753|NCT00414973|141515155|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for Week 12 Percentage Change.|Wilcoxon Rank-Sum Test|||||||<0.0001
71003754|NCT00414973|141515155|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for Week 24 Percentage Change.|Wilcoxon Rank-Sum Test|||||||<0.0001
71003755|NCT00414973|141515156|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.63|STANDARD_ERROR_OF_MEAN|2.2||0.2409||95.0|-1.87|7.13|||ANCOVA||Difference = Teriparatide minus Calcitonin|||7.13|-1.87|0.2409
71003756|NCT00414973|141515157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.96|STANDARD_ERROR_OF_MEAN|1.9||0.6156||95.0|-4.85|2.92|||ANCOVA||Difference = Teriparatide minus Calcitonin|||2.92|-4.85|0.6156
71003757|NCT00414973|141515158|SUPERIORITY_OR_OTHER|||||||0.0026||95.0||||P-value for Week 12 Percentage Change.|Wilcoxon Rank-Sum Test|||||||0.0026
71003758|NCT00414973|141515158|SUPERIORITY_OR_OTHER|||||||0.0006||95.0||||P-value for 24 Week Percentage Change.|Wilcoxon Rank-Sum Test|||||||0.0006
71003759|NCT01925014|141515169|NON_INFERIORITY|Detailed in Ahn S, LOCAT Group. Trials 2014:15:28.|Risk Difference (RD)|0.013|||||TWO_SIDED|95.0|-0.008|0.033|||||The non-inferiority was established.|Detailed in Ahn S, LOCAT Group. Trials 2014:15:28.||0.033|-0.008|
71003760|NCT01925014|141515170|NON_INFERIORITY|Detailed in Ahn S, LOCAT Group. Trials 2014:15:28.|Risk Difference (RD)|0.035|||||TWO_SIDED|95.0|-0.021|0.091|||||The non-inferiority was established.|Detailed in Ahn S, LOCAT Group. Trials 2014:15:28.||0.091|-0.021|
71003761|NCT00850135|141515205|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED|||||p-Value for the correlation between AUC-110 and birth weight|correlation|||||||0.035
71003762|NCT01487863|141515215|SUPERIORITY|||||||0.2141|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test.||||||0.2141
71003763|NCT02044367|141515223|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T1/R (%)|137.01|STANDARD_DEVIATION|26.8|||TWO_SIDED|90.0|125.773|149.25|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||149.250|125.773|
71003764|NCT02044367|141515223|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T2/R (%)|130.43|STANDARD_DEVIATION|27.1|||TWO_SIDED|90.0|119.628|142.2|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||142.200|119.628|
71003765|NCT02044367|141515224|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T1/R (%)|146.16|STANDARD_DEVIATION|31.6|||TWO_SIDED|90.0|132.217|161.576|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||161.576|132.217|
71003766|NCT02044367|141515224|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T2/R (%)|141.06|STANDARD_DEVIATION|31.5|||TWO_SIDED|90.0|127.644|155.876|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||155.876|127.644|
71008622|NCT02055976|141525234|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.644|STANDARD_ERROR_OF_MEAN|3.266||0.005|TWO_SIDED|95.0|2.157|15.13|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||15.130|2.157|0.005
71008623|NCT02055976|141525234|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|14.708|STANDARD_ERROR_OF_MEAN|3.272|<|0.001|TWO_SIDED|95.0|8.208|21.208|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||21.208|8.208|<0.001
71008624|NCT02055976|141525234|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.168|STANDARD_ERROR_OF_MEAN|3.317|<|0.001|TWO_SIDED|95.0|4.58|17.757|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||17.757|4.580|<0.001
71043534|NCT03581188|141596447|SUPERIORITY||Risk Ratio (RR)|0.0|||||TWO_SIDED|95.0|-9.0|10.0||||||New melanoma diagnoses prompted at scheduled visit||10|-9|
71043535|NCT03581188|141596448|SUPERIORITY||Mean Difference (Net)|-1.4|||||TWO_SIDED|95.0|-5.8|3.0||||||||3|-5.8|
71043536|NCT03064438|141596449|SUPERIORITY||Difference of Least Squares (LS) Mean|1.8|STANDARD_ERROR_OF_MEAN|1.95||0.366|TWO_SIDED|95.0|-2.162|5.727|||t-test, 2 sided|||||5.727|-2.162|0.366
71043537|NCT03064438|141596450|SUPERIORITY|||||||0.1099|||||||Van Elteren test|||Percent change from baseline at Week 2||||0.1099
71043538|NCT03064438|141596450|SUPERIORITY|||||||0.1653|||||||Van Elteren test|||Percent change from baseline at Week 4||||0.1653
71043539|NCT03064438|141596450|SUPERIORITY|||||||0.8437|||||||Van Elteren test|||Percent change from baseline at Week 8||||0.8437
71043540|NCT03064438|141596450|SUPERIORITY|||||||0.4644|||||||Van Elteren test|||Percent change from baseline at Week 12||||0.4644
71043541|NCT03064438|141596451|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71043542|NCT03064438|141596452|SUPERIORITY||Difference of LS Mean|1.3|STANDARD_ERROR_OF_MEAN|1.91||0.495|TWO_SIDED|95.0|-2.571|5.211|||t-test, 2 sided|||Change from baseline at Week 2||5.211|-2.571|0.495
71043543|NCT03064438|141596452|SUPERIORITY||Difference of LS Mean|-1.5|STANDARD_ERROR_OF_MEAN|1.74||0.399|TWO_SIDED|95.0|-5.014|2.045|||t-test, 2 sided|||Change from baseline at Week 4||2.045|-5.014|0.399
71043544|NCT03064438|141596452|SUPERIORITY||Difference of LS Mean|2.2|STANDARD_ERROR_OF_MEAN|2.07||0.29|TWO_SIDED|95.0|-1.965|6.407|||t-test, 2 sided|||Change from baseline at Week 8||6.407|-1.965|0.290
71043545|NCT03064438|141596452|SUPERIORITY||Difference of LS Mean|1.8|STANDARD_ERROR_OF_MEAN|1.83||0.343|TWO_SIDED|95.0|-1.953|5.469|||t-test, 2 sided|||Change from baseline at Week 12||5.469|-1.953|0.343
71101164|NCT01946880|141710383|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.1|0.1|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 24.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the SLICC/DI score between the treatment groups at Week 24.||0.1|-0.1|
71043546|NCT03064438|141596453|SUPERIORITY||Difference of LS Mean|0.6|STANDARD_ERROR_OF_MEAN|0.75||0.407|TWO_SIDED|95.0|-0.894|2.155|||t-test, 2 sided|||Change from baseline at Week 2||2.155|-0.894|0.407
71101165|NCT01946880|141710383|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.1|0.1|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 48.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the SLICC/DI score between the treatment groups at Week 48.||0.1|-0.1|
71043547|NCT03064438|141596453|SUPERIORITY||Difference of LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.36||0.291|TWO_SIDED|95.0|-0.342|1.109|||t-test, 2 sided|||Change from baseline at Week 4||1.109|-0.342|0.291
71101166|NCT01946880|141710383|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.2|0.1|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 60.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the SLICC/DI score between the treatment groups at Week 60.||0.1|-0.2|
71101167|NCT01946880|141710384|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.019|0.059||||||||0.059|-0.019|
71043548|NCT03064438|141596453|SUPERIORITY||Difference of LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.45||0.734|TWO_SIDED|95.0|-0.763|1.073|||t-test, 2 sided|||Change from baseline at Week 8||1.073|-0.763|0.734
71043549|NCT03064438|141596453|SUPERIORITY||Difference of LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.57||0.952|TWO_SIDED|95.0|-1.128|1.197|||t-test, 2 sided|||Change from baseline in pustule lesions at Week 12||1.197|-1.128|0.952
71043550|NCT03064438|141596454|SUPERIORITY||Difference of LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.313|TWO_SIDED|95.0|-0.215|0.069|||t-test, 2 sided|||Change from baseline at Week 2||0.069|-0.215|0.313
71043551|NCT03064438|141596454|SUPERIORITY||Difference of LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.942|TWO_SIDED|95.0|-0.141|0.152|||t-test, 2 sided|||Change from baseline at Week 4||0.152|-0.141|0.942
71043552|NCT03064438|141596454|SUPERIORITY||Difference of LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.284|TWO_SIDED|95.0|-0.067|0.226|||t-test, 2 sided|||Change from baseline in nodule lesions at Week 8||0.226|-0.067|0.284
71043553|NCT03064438|141596454|SUPERIORITY||Difference of LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.542|TWO_SIDED|95.0|-0.198|0.105|||t-test, 2 sided|||Change from baseline at Week 12||0.105|-0.198|0.542
71043554|NCT03064438|141596455|SUPERIORITY||Difference of LS Mean|2.0|STANDARD_ERROR_OF_MEAN|2.04||0.333|TWO_SIDED|95.0|-2.135|6.139|||t-test, 2 sided|||Change from baseline at Week 2||6.139|-2.135|0.333
71043555|NCT03064438|141596455|SUPERIORITY||Difference of LS Mean|-1.0|STANDARD_ERROR_OF_MEAN|1.9||0.591|TWO_SIDED|95.0|-4.882|2.822|||t-test, 2 sided|||Change from baseline at Week 4||2.822|-4.882|0.591
71043556|NCT03064438|141596455|SUPERIORITY||Difference of LS Mean|2.5|STANDARD_ERROR_OF_MEAN|2.12||0.254|TWO_SIDED|95.0|-1.84|6.758|||t-test, 2 sided|||Change from baseline at Week 8||6.758|-1.840|0.254
71043557|NCT03064438|141596455|SUPERIORITY||Difference of LS Mean|1.8|STANDARD_ERROR_OF_MEAN|1.95||0.356|TWO_SIDED|95.0|-2.131|5.779|||t-test, 2 sided|||Change from baseline at Week 12||5.779|-2.131|0.356
71043558|NCT01552369|141596499|SUPERIORITY|||||||0.0396|||||||Mantel Haenszel|||||||0.0396
71043559|NCT01552369|141596499|SUPERIORITY||Hazard Ratio (HR)|2.22||||0.048|TWO_SIDED|95.0|1.01|7.3|||Competing risk regression|Death was considered a competing risk.|The risk of CMV disease is 2.2x higher in the prophylaxis group when compared to the preemptive group|||7.3|1.01|0.048
71043560|NCT01552369|141596500|SUPERIORITY|log-rank test for equality of survivor functions||||||0.19|||||||Log Rank|||||||0.19
71043561|NCT01552369|141596501|SUPERIORITY||Odds Ratio (OR)|0.85||||0.6|TWO_SIDED|95.0|0.45|1.58|||Mantel Haenszel||The odds of rejection in prophylaxis group compared to preemptive group|||1.58|0.45|0.60
71043562|NCT01552369|141596502|SUPERIORITY||Odds Ratio (OR)|0.95||||0.96|TWO_SIDED|95.0|0.13|6.92|||Mantel Haenszel||The odds of graft loss in prophylaxis group compared to preemptive group|||6.92|0.13|0.96
71043563|NCT01552369|141596503|SUPERIORITY||Odds Ratio (OR)|3.24||||0.014|TWO_SIDED|95.0|1.21|8.69|||Mantel Haenszel||Odds of late disease in prophylaxis group compared to preemptive|||8.69|1.21|0.014
71101168|NCT01946880|141710386|OTHER||Mean Difference (Final Values)|1.61|||||TWO_SIDED|95.0|-2.24|5.45|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 24.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the FACIT fatigue score between the treatment groups at Week 24.||5.45|-2.24|
71101169|NCT01946880|141710386|OTHER||Mean Difference (Final Values)|2.54|||||TWO_SIDED|95.0|-1.13|6.21|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 48.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the FACIT fatigue score between the treatment groups at Week 48.||6.21|-1.13|
71101170|NCT01946880|141710386|OTHER||Mean Difference (Final Values)|3.55|||||TWO_SIDED|95.0|-0.17|7.28|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 60.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the FACIT fatigue score between the treatment groups at Week 60.||7.28|-0.17|
71003767|NCT02044367|141515225|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T1/R (%)|137.61|STANDARD_DEVIATION|26.5|||TWO_SIDED|90.0|126.418|149.797|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||149.797|126.418|
71101171|NCT01946880|141710387|OTHER||Mean Difference (Final Values)|0.55|||||TWO_SIDED|95.0|-1.82|2.92|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 24.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PF score between the treatment groups at Week 24.||2.92|-1.82|
71101172|NCT01946880|141710387|OTHER||Mean Difference (Final Values)|1.44|||||TWO_SIDED|95.0|-1.14|4.03|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 48.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PF score between the treatment groups at Week 48.||4.03|-1.14|
71101173|NCT01946880|141710387|OTHER||Mean Difference (Final Values)|1.98|||||TWO_SIDED|95.0|-0.71|4.67|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 60.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PF score between the treatment groups at Week 60.||4.67|-0.71|
70924656|NCT04321031|141342041|SUPERIORITY||Risk Difference (RD)|0.21|||||TWO_SIDED|90.0|0.09|0.32|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.32|0.09|
70924657|NCT04321031|141342041|SUPERIORITY||Risk Difference (RD)|0.27|||||TWO_SIDED|90.0|0.15|0.37|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.37|0.15|
70924658|NCT04321031|141342041|SUPERIORITY||Risk Difference (RD)|0.29|||||TWO_SIDED|90.0|0.18|0.39|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.39|0.18|
70924659|NCT04321031|141342041|SUPERIORITY||Risk Difference (RD)|0.31|||||TWO_SIDED|90.0|0.19|0.42|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.42|0.19|
70924660|NCT04321031|141342042|SUPERIORITY||Risk Difference (RD)|0.23|||||TWO_SIDED|90.0|0.04|0.51||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.51|0.04|
71003768|NCT02044367|141515225|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T2/R (%)|132.0|STANDARD_DEVIATION|28.0|||TWO_SIDED|90.0|120.714|144.342|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||144.342|120.714|
71003769|NCT02044367|141515226|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T1/R (%)|147.8|STANDARD_DEVIATION|32.4|||TWO_SIDED|90.0|133.384|163.779|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||163.779|133.384|
71003770|NCT02044367|141515226|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T2/R (%)|144.8|STANDARD_DEVIATION|32.0|||TWO_SIDED|90.0|130.853|160.242|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||160.242|130.853|
71101174|NCT01946880|141710388|OTHER||Mean Difference (Final Values)|1.65|||||TWO_SIDED|95.0|-1.03|4.32|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 24.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PCS score between the treatment groups at Week 24.||4.32|-1.03|
70924661|NCT04321031|141342042|SUPERIORITY||Risk Difference (RD)|0.37|||||TWO_SIDED|90.0|0.13|0.63||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.63|0.13|
70924662|NCT04321031|141342042|SUPERIORITY||Risk Difference (RD)|0.22|||||TWO_SIDED|90.0|0.04|0.49||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.49|0.04|
70924663|NCT04321031|141342042|SUPERIORITY||Risk Difference (RD)|0.54|||||TWO_SIDED|90.0|0.26|0.75||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.75|0.26|
70924664|NCT04321031|141342042|SUPERIORITY||Risk Difference (RD)|0.34|||||TWO_SIDED|90.0|0.1|0.61||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.61|0.10|
70924665|NCT04321031|141342042|SUPERIORITY||Risk Difference (RD)|0.48|||||TWO_SIDED|90.0|0.2|0.72||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.72|0.20|
70924666|NCT04321031|141342042|SUPERIORITY||Risk Difference (RD)|0.32|||||TWO_SIDED|50.0|0.24|0.39||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.39|0.24|
70924667|NCT04321031|141342042|SUPERIORITY||Risk Difference (RD)|0.32|||||TWO_SIDED|90.0|0.12|0.48||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.48|0.12|
70924668|NCT04321031|141342042|SUPERIORITY||Risk Difference (RD)|0.14|||||TWO_SIDED|50.0|0.06|0.23||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.23|0.06|
70924669|NCT04321031|141342042|SUPERIORITY||Risk Difference (RD)|0.14|||||TWO_SIDED|90.0|-0.06|0.33||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.33|-0.06|
71003771|NCT01302691|141515242|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.1||||0.205|TWO_SIDED|95.0|-2.7|0.6|||Constrained Longitudinal Data Analysis|Model includes treatment group, time point, and the interaction of time by treatment with restriction of same baseline mean across treatment groups||||0.6|-2.7|0.205
71003772|NCT01302691|141515248|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-3.2||||0.011|TWO_SIDED|95.0|-5.7|-0.8|||Constrained Longitudinal Data Analysis|Model includes treatment group, time point, and the interaction of time by treatment with restriction of same baseline mean across treatment groups||||-0.8|-5.7|0.011
71003773|NCT00441012|141515263|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|100.0||||||95.0|98.7|100.0|||||Exact binomial confidence interval|The purpose of the primary analysis is to demonstrate that there is an adequate seroprotection rate (percentage of participants with anti-HBs \>=10mIU/mL) in each group at 1 month after the third dose. An adequate response requires the lower bound of the two-sided 95% confidence interval for the seroprotection rate to exceed 90%.||100.0|98.7|
71003774|NCT00441012|141515263|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|99.1||||||95.0|69.9|99.9|||||Exact binomial confidence interval|The purpose of the primary analysis is to demonstrate that there is an adequate seroprotection rate (percentage of participants with anti-HBs \>=10mIU/mL) in each group at 1 month after the third dose. An adequate response requires the lower bound of the two-sided 95% confidence interval for the seroprotection rate to exceed 90%.||99.9|69.9|
71003775|NCT00441012|141515264|NON_INFERIORITY_OR_EQUIVALENCE|The Modified Process Vaccine is non-inferior to COMVAX with respect to anti-HBs GMT. The non-inferiority criterion requires that the lower bound of the two-sided 95% confidence interval on the ratio of the Month 11 GMTs \[GMT modified process vaccine/GMT COMVAX™\] is \>0.67.|Geometric Mean Titer Ratio|2.5||||||95.0|1.9|3.3||||||||3.3|1.9|
71003776|NCT00441012|141515266|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|93.9||||||95.0|90.0|96.6|||||Exact binomial confidence interval|||96.6|90.0|
71003777|NCT00441012|141515266|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|92.1||||||95.0|87.8|95.3|||||Exact binomial confidence interval|No hypothesis is being tested. The purpose of the secondary analysis is to estimate the seroprotection rate (percentage of participants with anti-PRP \> 1µg/mL) in each group at 1 month after the third dose.||95.3|87.8|
70924670|NCT04321031|141342043|SUPERIORITY||Risk Difference (RD)|-0.05|||||TWO_SIDED|90.0|-0.16|0.02|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.02|-0.16|
71003778|NCT03674541|141515269|SUPERIORITY|||||||0.043|||||||Welch's t-test|||||||0.043
71003779|NCT03674541|141515270|SUPERIORITY|||||||0.008||||||P-value was not adjusted for multiplicity for secondary outcomes|Welch's t-test|||||||0.008
71003780|NCT03674541|141515271|SUPERIORITY|||||||0.263||||||Not adjusted for multiplicity|Welch's t-test|||||||0.263
71003781|NCT03674541|141515272|SUPERIORITY|||||||0.039||||||Not adjusted for multiplicity|Welch's t-test|||||||0.039
71003782|NCT03674541|141515273|SUPERIORITY|||||||0.068||||||Not adjusted for multiplicity|Welch's t-test|||||||0.068
71003783|NCT03674541|141515274|SUPERIORITY|||||||0.045||||||Not adjusted for multiplicity|Welch's t-test|||||||0.045
71003784|NCT03674541|141515275|SUPERIORITY|||||||1||||||Not adjusted multiplicity|Welch's t-test|||||||1.000
71003785|NCT03674541|141515276|SUPERIORITY|||||||0.093||||||Not adjusted for multiplicity|Welch's t-test|||||||0.093
71003786|NCT03674541|141515277|SUPERIORITY|||||||0.427||||||Not adjusted for multiplicity|Welch's t-test|||||||0.427
71003787|NCT03674541|141515278|SUPERIORITY|||||||0.262||||||Not adjusted for multiplicity|Welch's t-test|||||||0.262
71003788|NCT03674541|141515279|SUPERIORITY|||||||0.038||||||Not adjusted for multiplicity|Welch's t-test|||||||0.038
71003789|NCT03674541|141515280|SUPERIORITY|||||||0.147|||||||Welch's t-test|||||||0.147
71003790|NCT00117572|141515313|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.68|TWO_SIDED|95.0|0.59|1.41|||Log Rank||Hazard ratio is (Induction+CRT)/CRT|Comparison of overall survival curves||1.41|0.59|0.68
71003791|NCT00117572|141515314|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.37|TWO_SIDED|95.0|0.55|1.25|||Log Rank||Hazard ratio is (Induction+CRT)/CRT|||1.25|0.55|0.37
71003792|NCT00117572|141515315|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.16|TWO_SIDED|95.0|0.51|1.12|||Log Rank||Hazard ratio is (Induction+CRT)/CRT|||1.12|0.51|0.16
71003793|NCT00117572|141515316|SUPERIORITY_OR_OTHER|||||||0.57|||||||Fisher Exact|||||||0.57
71003794|NCT00117572|141515317|SUPERIORITY_OR_OTHER|||||||0.11|||||||Fisher Exact|||||||0.11
71003795|NCT00117572|141515318|SUPERIORITY_OR_OTHER|||||||0.55|||||||t-test, 2 sided|Comparison of change scores between treatment groups||||||0.55
71003796|NCT00117572|141515319|SUPERIORITY_OR_OTHER|||||||0.034|||||||t-test, 2 sided|||||||0.034
71003797|NCT00117572|141515320|SUPERIORITY_OR_OTHER|||||||0.35|||||||t-test, 2 sided|||||||0.35
71003798|NCT00117572|141515321|SUPERIORITY_OR_OTHER|||||||0.96|||||||t-test, 2 sided|||||||0.96
71003799|NCT00117572|141515322|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||t-test, 2 sided|||||||0.88
71003800|NCT00117572|141515323|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||t-test, 2 sided|||||||0.83
71003801|NCT00117572|141515324|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||t-test, 2 sided|||||||0.49
71003802|NCT00117572|141515325|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||t-test, 2 sided|||||||0.090
71003803|NCT04973085|141515331|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
71003804|NCT00864123|141515367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0|STANDARD_DEVIATION|6.3|<|0.05||95.0|||||ANOVA|||Data were analyzed with separate 2 (site: Florida, MGH) by 2 (condition: CBT+DCS, CBT+Placebo) by 3 (time: pre-treatment, mid-treatment, post-treatment; Dependent variables: CY-BOCS Total Score) fixed-effects linear regression with time as the repeated measure. Cohen's d was used to examine the magnitude of treatment effects.||||<0.05
71003805|NCT00864123|141515368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|1.1|<|0.05|TWO_SIDED|95.0|||||ANOVA|||Data were analyzed with separate 2 (site: Florida, MGH) by 2 (condition: CBT+DCS, CBT+Placebo) by 3 (time: pre-treatment, mid-treatment, post-treatment; Dependent variables: CGI-Severity) fixed-effects linear regression with time as the repeated measure. Cohen's d was used to examine the magnitude of treatment effects.||||<0.05
71003806|NCT00796224|141515370|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|157.98||||||90.0|98.87|252.44|||ANOVA|||Test (60 mg/kg Azithromycin ER)/ Reference (30 mg/kg Azithromycin IR)||252.44|98.87|
71003807|NCT00796224|141515372|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|91.63||||||90.0|56.21|149.38|||ANOVA|||||149.38|56.21|
71003808|NCT00796224|141515374|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|65.44||||||90.0|23.56|181.77|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 1 hour postdose||181.77|23.56|
71003809|NCT00796224|141515374|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|50.57||||||90.0|25.24|101.3|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 2 hours postdose||101.30|25.24|
71003810|NCT00796224|141515374|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|100.07||||||90.0|57.91|172.92|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 3 hours postdose||172.92|57.91|
71003811|NCT00796224|141515374|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|164.93||||||90.0|103.78|262.12|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 4 hours postdose||262.12|103.78|
71003812|NCT00796224|141515374|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|174.41||||||90.0|110.07|276.36|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 8 hours postdose||276.36|110.07|
71043564|NCT01552369|141596504|SUPERIORITY||Odds Ratio (OR)|1.17||||0.64|TWO_SIDED|95.0|0.61|2.23|||Mantel Haenszel||Odds of bacterial infection in prophylaxis subjects compared to preemptive|||2.23|0.61|0.64
71043565|NCT01552369|141596505|SUPERIORITY||Odds Ratio (OR)|2.25||||0.18|TWO_SIDED|95.0|0.66|7.62|||Mantel Haenszel||Odds of fungal disease in prophylaxis group compared to preemptive|||7.62|0.66|0.18
71043566|NCT01552369|141596506|SUPERIORITY|||||||0.24|||||||Fisher Exact|||||||0.24
71101175|NCT01946880|141710388|OTHER||Mean Difference (Final Values)|2.17|||||TWO_SIDED|95.0|-0.69|5.02|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 48.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PCS score between the treatment groups at Week 48.||5.02|-0.69|
71101176|NCT01946880|141710388|OTHER||Mean Difference (Final Values)|3.02|||||TWO_SIDED|95.0|0.22|5.82|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 60.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PCS score between the treatment groups at Week 60.||5.82|0.22|
71101177|NCT04543786|141710411|OTHER|No comparison was made to another intervention or therapy. Comparing values at baseline and Day 2.|Mean Difference (Final Values)|2.8||||0.0048|TWO_SIDED|||||Bonferroni post-hoc tests; p \< 0.05 was considered significant|ANOVA|One-way||||||0.0048
71003813|NCT00796224|141515374|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|173.01||||||90.0|111.45|268.55|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 24 hours postdose||268.55|111.45|
71003814|NCT00796224|141515374|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|189.35||||||90.0|129.76|276.3|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 48 hours postdose||276.30|129.76|
71003815|NCT00796224|141515374|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|183.14||||||90.0|124.61|269.14|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 72 hours postdose||269.14|124.61|
71003816|NCT03227224|141515389|SUPERIORITY||Difference of Least Square Means|0.9||||0.724|TWO_SIDED|90.0|-3.12|4.82|||Mixed model for repeated measures (MMRM)|||||4.82|-3.12|0.724
71003817|NCT03227224|141515389|SUPERIORITY||Difference of Least Square Means|-3.1||||0.083|TWO_SIDED|90.0|-6.13|-0.16|||MMRM|||||-0.16|-6.13|0.083
71003818|NCT03227224|141515389|SUPERIORITY||Difference of Least Square Means|-1.5||||0.424|TWO_SIDED|90.0|-4.7|1.63|||MMRM|||||1.63|-4.70|0.424
71003819|NCT04195750|141515431|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.00031|TWO_SIDED|95.0|0.63|0.88|||Log Rank|One-sided p-value based on log-rank test stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|||0.88|0.63|0.00031
71003820|NCT04195750|141515432|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.17644|TWO_SIDED|95.0|0.77|1.1|||Log Rank|One-sided p-value based on log-rank test stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|||1.10|0.77|0.17644
71003821|NCT04195750|141515433|SUPERIORITY|P-value, difference in percentage and associated 95% CI were calculated using Miettinen \& Nurminen method stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|Difference in Percentage|18.4|||<|1e-05|TWO_SIDED|95.0|14.0|23.2||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Miettinen & Nurminen||Belzutifan minus Everolimus|||23.2|14.0|<0.00001
71101178|NCT04543786|141710412|OTHER|No comparison was made to another intervention or therapy. Comparing values at baseline and Day 3.|Mean Difference (Final Values)|3.72|||<|0.001|TWO_SIDED|||||Bonferroni post-hoc tests; p \< 0.05 was considered significant|ANOVA|||||||< 0.001
71003822|NCT04195750|141515437|OTHER||Hazard Ratio (HR)|0.75||||0.0185|TWO_SIDED|95.0|0.58|0.96|||Log Rank|Two-sided p-value based on log-rank test stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|||0.96|0.58|0.0185
71043567|NCT01552369|141596507|SUPERIORITY|||||||0.69|||||||Chi-squared|||||||0.69
71043568|NCT01552369|141596508|SUPERIORITY|||||||0.57|||||||Chi-squared|||||||0.57
71043569|NCT01552369|141596509|SUPERIORITY|||||||0.61|||||||Chi-squared|||||||0.61
71043570|NCT01316419|141596510|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Mean SBP change from baseline at the last visit will be analyzed by paired t-test|Paired t test|||||||<0.0001
71043571|NCT01316419|141596513|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Mean DBP change from baseline at the last visit will be analyzed by paired t-test|Paired t test|||||||<0.0001
71043572|NCT01316419|141596515|SUPERIORITY_OR_OTHER|||||||0.1099|TWO_SIDED|||||The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test|Paired t test|||||||0.1099
71043573|NCT01316419|141596516|SUPERIORITY_OR_OTHER|||||||0.0197|TWO_SIDED|||||The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test|Paired t test|||||||0.0197
71043574|NCT01316419|141596517|SUPERIORITY_OR_OTHER|||||||0.4543|TWO_SIDED|||||The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test|Paired t test|||||||0.4543
71101179|NCT04543786|141710413|OTHER|No comparison was made to another intervention or therapy. Comparing values at baseline and Day 4.|Mean Difference (Final Values)|3.24|||<|0.001|TWO_SIDED|||||Bonferroni post-hoc tests; p \< 0.05 was considered significant|ANOVA|||||||<0.001
71101180|NCT04543786|141710414|OTHER|No comparison was made to another intervention or therapy. Comparing values at baseline and Day 5.|Mean Difference (Final Values)|20.84|||<|0.001|TWO_SIDED|||||Bonferroni post-hoc tests; p \< 0.05 was considered significant|ANOVA|||||||<0.001
71003823|NCT04195750|141515438|OTHER||Hazard Ratio (HR)|0.93||||0.5533|TWO_SIDED|95.0|0.72|1.2|||Log Rank|Two-sided p-value based on log-rank test stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|||1.20|0.72|0.5533
71003824|NCT04195750|141515439|OTHER||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.41|0.69|||Log Rank|Two-sided p-value based on log-rank test stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|||0.69|0.41|<0.0001
71003825|NCT04195750|141515440|OTHER||Difference in Least Squares (LS) Means|6.38|||<|0.0001|TWO_SIDED|95.0|3.21|9.55|||t-test, 2 sided||Based on a cLDA model with scores as the response variable with covariates for treatment by time interaction, stratification factors (IMDC Risk Category, and Number of Prior VEGF/VEGF-Receptor Targeted Therapies for RCC) as covariates.|||9.55|3.21|<0.0001
71003826|NCT04195750|141515441|OTHER||Difference in LS Means|2.47||||0.1134|TWO_SIDED|95.0|-0.59|5.54|||t-test, 2 sided||Based on a cLDA model with scores as the response variable with covariates for treatment by time interaction, stratification factors (IMDC Risk Category, and Number of Prior VEGF/VEGF-Receptor Targeted Therapies for RCC) as covariates.|||5.54|-0.59|0.1134
71003827|NCT04195750|141515442|OTHER||Difference in LS Means|1.45||||0.0002|TWO_SIDED|95.0|0.7|2.19|||t-test, 2 sided||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (IMDC Risk Category, and Number of Prior VEGF/VEGF-Receptor Targeted Therapies for RCC) as covariates.|||2.19|0.70|0.0002
71003828|NCT04195750|141515443|OTHER||Difference in LS Means|3.72||||0.0051|TWO_SIDED|95.0|1.12|6.31|||t-test, 2 sided||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (IMDC Risk Category, and Number of Prior VEGF/VEGF-Receptor Targeted Therapies for RCC) as covariates.|||6.31|1.12|0.0051
71003829|NCT03782376|141515483|SUPERIORITY||Difference in percentage|11.5||||0.089|TWO_SIDED|95.0|-1.5|24.5||Threshold for significance was 0.05 level.|Cochran-Mantel Haenszel-chi-square test|||The fixed sequence testing method was used. CMH chi-square test (2-sided) stratified by baseline CDAI score (\<= 300 or \> 300), and prior biologic failure status at baseline (yes or no).||24.5|-1.5|0.089
71003830|NCT03782376|141515484|SUPERIORITY||Difference in percentage|5.9||||0.338|TWO_SIDED|95.0|-6.0|17.8|||CMH chi-square test (2-sided)|||The fixed sequence testing method was used. CMH chi-square test (2-sided) stratified by baseline CDAI score (\<= 300 or \> 300), and prior biologic failure status at baseline (yes or no).||17.8|-6.0|0.338
71003831|NCT03782376|141515485|SUPERIORITY||Difference in percentage|7.1||||0.3|TWO_SIDED|95.0|-6.0|20.2|||CMH chi-square test (2-sided)|||The fixed sequence testing method was used. CMH chi-square test (2-sided) stratified by baseline CDAI score (\<= 300 or \> 300), and prior biologic failure status at baseline (yes or no).||20.2|-6.0|0.300
71003832|NCT03782376|141515486|SUPERIORITY||Difference in percentage|6.4||||0.314|TWO_SIDED|95.0|-5.8|18.6|||CMH chi-square test (2-sided)|||The fixed sequence testing method was used. CMH chi-square test (2-sided) stratified by baseline CDAI score (\<= 300 or \> 300), and prior biologic failure status at baseline (yes or no).||18.6|-5.8|0.314
71101181|NCT04543786|141710416|OTHER|No comparison was made to another intervention or therapy. Comparing values at baseline and Day 5.|Mean Difference (Final Values)|26.78|||<|0.001|TWO_SIDED|||||p \< 0.05 was considered significant|t-test, 2 sided|paired||||||<0.001
71003833|NCT03782376|141515487|SUPERIORITY||Difference in percentage|18.5||||0.004|TWO_SIDED|95.0|6.8|30.2|||CMH chi-square test (2-sided)|||The fixed sequence testing method was used. CMH chi-square test (2-sided) stratified by baseline CDAI score (\<= 300 or \> 300), and prior biologic failure status at baseline (yes or no).||30.2|6.8|0.004
71003834|NCT03559192|141515501|SUPERIORITY||Least Squares Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|1.25|=|0.0443|ONE_SIDED|80.0||-1.09|||Mixed Models Analysis|||||-1.09||= 0.0443
71003835|NCT03559192|141515502|SUPERIORITY||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|1.05||0.0017|ONE_SIDED|80.0||-2.21|||Mixed Models Analysis|||||-2.21||0.0017
71003836|NCT03559192|141515504|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.87|=|0.4188|ONE_SIDED|80.0||0.41|||Mixed Models Analysis|||||0.41||= 0.4188
71003837|NCT03559192|141515505|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.73||0.2503|ONE_SIDED|80.0||0.1|||Mixed Models Analysis|||||0.10||0.2503
71003838|NCT03517722|141515520|SUPERIORITY||Odds Ratio (OR)|0.6||||0.042|TWO_SIDED|95.0|0.4|1.0|||Regression, Logistic|||||1.0|0.4|0.042
71003839|NCT05849441|141515529|SUPERIORITY|||||||0.04||||||This is for the subscale: Support-Seeking.|Regression, Linear|||||||0.04
71101182|NCT04543786|141710417|OTHER|No comparison was made to another intervention or therapy|Mean Difference (Final Values)|1.3||||0.56|TWO_SIDED|||||p \< 0.05 was considered significant|ANOVA|Repeated measures||||||0.56
71101183|NCT04543786|141710418|OTHER|No comparison was made to another intervention or therapy|Mean Difference (Final Values)|2.3||||0.56|TWO_SIDED|||||p \< 0.05 was considered significant|ANOVA|Repeated measures||||||0.56
71101184|NCT04543786|141710419|OTHER|No comparison was made to another intervention or therapy|Mean Difference (Final Values)|1.2||||0.56|TWO_SIDED|||||p \< 0.05 was considered significant|ANOVA|Repeated measures||||||0.56
71101185|NCT04543786|141710420|OTHER|No comparison was made to another intervention or therapy.|Mean Difference (Final Values)|1.5||||0.56|TWO_SIDED|||||p \< 0.05 was considered significant|ANOVA|Repeated measures||||||0.56
71101186|NCT04204902|141710425|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90 percentage Confidence Interval (CI) as 80.00 percentage - 125.00 percentage|Ratio of Geometric Least Square Mean|91.15|||||TWO_SIDED|90.0|83.21|99.84||||||||99.84|83.21|
71003840|NCT05849441|141515529|SUPERIORITY|||||||0.02||||||This is for subscale: Problem Solving|Regression, Linear|||||||0.02
71003841|NCT05849441|141515529|SUPERIORITY|||||||0.55||||||This is for subscale: Distancing|Regression, Linear|||||||0.55
71003842|NCT05849441|141515529|SUPERIORITY|||||||0.79||||||This is for subscale: Internalizing|Regression, Linear|||||||0.79
71003843|NCT05849441|141515529|SUPERIORITY|||||||0.93||||||This is for subscale: Externalizing|Regression, Linear|||||||0.93
71003844|NCT05849441|141515529|SUPERIORITY|||||||0.09||||||This is for subscale: Mindfulness|Regression, Linear|||||||0.09
71003845|NCT05849441|141515530|SUPERIORITY|||||||0.32||||||This is for subscale: Reappraisal|Regression, Linear|||||||0.32
71003846|NCT05849441|141515530|SUPERIORITY|||||||0.24||||||This is for subscale: Suppression|Regression, Linear|||||||0.24
71003847|NCT05849441|141515531|SUPERIORITY|||||||0.53||||||This is for subscale: Manage own emotions|Regression, Linear|||||||0.53
71003848|NCT05849441|141515531|SUPERIORITY|||||||0.16||||||This is for subscale: Identify and Understand Own Emotions|Regression, Linear|||||||0.16
71003849|NCT05849441|141515531|SUPERIORITY|||||||0.27||||||This is for subscale: Deal with emotions of others|Regression, Linear|||||||0.27
71003850|NCT05849441|141515531|SUPERIORITY|||||||0.59||||||This is for subscale: Perceive emotions through faces and bodies|Regression, Linear|||||||0.59
71003851|NCT05849441|141515532|SUPERIORITY|||||||0.16|||||||Regression, Linear|||||||0.16
71003852|NCT05849441|141515533|SUPERIORITY|||||||0.65||||||This is for subscale: Fear of Negative Evaluation|Regression, Linear|||||||0.65
71003853|NCT05849441|141515533|SUPERIORITY|||||||0.6||||||This is for subscale: Social avoidance and distress (new)|Regression, Linear|||||||0.60
71003854|NCT05849441|141515533|SUPERIORITY|||||||0.23||||||This is for subscale: social avoidance and distress (general)|Regression, Linear|||||||0.23
71003855|NCT05849441|141515534|SUPERIORITY|||||||0.55|||||||Regression, Linear|||||||0.55
71003856|NCT05849441|141515535|SUPERIORITY|||||||0.11||||||This is for subscale: Negativity|Regression, Linear|||||||0.11
71003857|NCT05849441|141515535|SUPERIORITY|||||||0.79||||||This is for subscale: Emotion regulation|Regression, Linear|||||||0.79
71003858|NCT05849441|141515536|SUPERIORITY|||||||0.14||||||This is for subscale: Working Memory|Regression, Linear|||||||0.14
71003859|NCT05849441|141515536|SUPERIORITY|||||||0.2||||||This is for subscale: Planning|Regression, Linear|||||||0.20
71003860|NCT05849441|141515536|SUPERIORITY|||||||0.48||||||This is for subscale: Inhibit|Regression, Linear|||||||0.48
71003861|NCT05849441|141515536|SUPERIORITY|||||||0.37||||||This is for subscale: Regulation|Regression, Linear|||||||0.37
71003862|NCT05849441|141515537|SUPERIORITY|||||||0.45|||||||Regression, Linear|||||||0.45
71003863|NCT05849441|141515538|SUPERIORITY|||||||0.88|||||||Regression, Linear|||||||0.88
71003864|NCT03277794|141515539|OTHER||Odds Ratio (OR)|2.28|STANDARD_ERROR_OF_MEAN|0.89||0.354|TWO_SIDED||||||Regression, Logistic|||Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)||||0.354
71101187|NCT04204902|141710426|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90 percentage Confidence Interval (CI) as 80.00 percentage - 125.00 percentage|Ratio of Geometric Least square Mean|90.92|||||TWO_SIDED|90.0|82.99|99.61||||||||99.61|82.99|
71003865|NCT03277794|141515539|OTHER||Odds Ratio (OR)|2.01|STANDARD_ERROR_OF_MEAN|0.95||0.465|TWO_SIDED||||||Regression, Logistic|||Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)||||0.465
71003866|NCT03277794|141515540|OTHER||Odds Ratio (OR)|2.31|STANDARD_ERROR_OF_MEAN|0.59||0.159|TWO_SIDED||||||Regression, Logistic|||Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)||||0.159
71003867|NCT03277794|141515540|OTHER||Odds Ratio (OR)|2.3|STANDARD_ERROR_OF_MEAN|0.64||0.2|TWO_SIDED||||||Regression, Linear|||Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)||||0.200
71003868|NCT03277794|141515541|OTHER||Odds Ratio (OR)|3.18|STANDARD_ERROR_OF_MEAN|0.74||0.121|TWO_SIDED||||||Regression, Logistic|||Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)||||0.121
71003869|NCT03277794|141515541|OTHER||Odds Ratio (OR)|3.63|STANDARD_ERROR_OF_MEAN|0.85||0.134|TWO_SIDED||||||Regression, Logistic|||Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)||||0.134
71003870|NCT03277794|141515542|OTHER|||||||0.899||||||Unadjusted.|Regression, Linear|||||||0.899
71003871|NCT03277794|141515542|OTHER|||||||0.128||||||Unadjusted|Regression, Linear|||||||0.128
71003872|NCT03277794|141515543|OTHER|||||||0.198||||||Unadjusted.|Regression, Linear|||||||0.198
71003873|NCT03277794|141515543|OTHER|||||||0.017||||||Unadjusted.|Regression, Linear|||||||0.017
71003874|NCT03277794|141515544|OTHER|||||||0.091||||||Unadjusted.|Regression, Linear|||||||0.091
71003875|NCT03277794|141515544|OTHER|||||||0.591||||||Unadjusted.|Regression, Linear|||||||0.591
71003876|NCT03277794|141515545|OTHER|||||||0.03||||||Unadjusted.|Regression, Linear|||||||0.030
71003877|NCT03277794|141515545|OTHER|||||||0.005||||||Unadjusted.|Regression, Linear|||||||0.005
71003878|NCT03277794|141515546|OTHER|||||||0.163||||||Unadjusted.|Regression, Linear|||||||0.163
71003879|NCT03277794|141515546|OTHER|||||||0.865||||||Unadjusted.|Regression, Linear|||||||0.865
71003880|NCT03277794|141515547|OTHER|||||||0.98||||||Unadjusted.|Regression, Linear|||||||0.980
71003881|NCT03277794|141515547|OTHER|||||||0.758||||||Unadjusted.|Regression, Linear|||||||0.758
71003882|NCT03277794|141515548|OTHER|||||||0.124||||||Unadjusted.|Regression, Linear|||||||0.124
71003883|NCT03277794|141515548|OTHER|||||||0.168||||||Unadjusted.|Regression, Linear|||||||0.168
71003884|NCT03277794|141515549|OTHER|||||||0.436||||||Unadjusted.|Regression, Linear|||||||0.436
71003885|NCT03277794|141515549|OTHER|||||||0.706||||||Unadjusted.|Regression, Linear|||||||0.706
71003886|NCT03277794|141515550|OTHER|||||||0.604||||||Unadjusted.|Regression, Linear|||Internalizing||||0.604
71003887|NCT03277794|141515550|OTHER|||||||0.177||||||Unadjusted.|Regression, Linear|||Internalizing||||0.177
71003888|NCT03277794|141515550|OTHER|||||||0.325||||||Unadjusted.|Regression, Linear|||Externalizing||||0.325
71003889|NCT03277794|141515550|OTHER|||||||0.227||||||Unadjusted.|Regression, Linear|||Externalizing||||0.227
71003890|NCT03277794|141515550|OTHER|||||||0.106||||||Unadjusted.|Regression, Linear|||Substance Use||||0.106
71003891|NCT03277794|141515550|OTHER|||||||0.058||||||Unadjusted.|Regression, Linear|||Substance Use||||0.058
71003892|NCT03277794|141515551|OTHER|||||||0.862||||||Unadjusted.|Regression, Linear|||Emotional Supports||||0.862
71003893|NCT03277794|141515551|OTHER|||||||0.382||||||Unadjusted.|Regression, Linear|||Emotional Supports||||0.382
71003894|NCT03277794|141515551|OTHER|||||||0.68||||||Unadjusted.|Regression, Linear|||Tangible Supports||||0.680
71003895|NCT03277794|141515551|OTHER|||||||0.988||||||Unadjusted.|Regression, Linear|||Tangible Supports||||0.988
71003896|NCT03277794|141515551|OTHER|||||||0.701||||||Unadjusted.|Regression, Linear|||Affectionate||||0.701
71003897|NCT03277794|141515551|OTHER|||||||0.154||||||Unadjusted.|Regression, Linear|||Affectionate||||0.154
71003898|NCT03277794|141515552|OTHER|||||||0.719||||||Unadjusted.|Regression, Linear|||Physical Health||||0.719
71003899|NCT03277794|141515552|OTHER|||||||0.15||||||Unadjusted.|Regression, Linear|||Physical Health||||0.150
71003900|NCT03277794|141515552|OTHER|||||||0.789||||||Unadjusted.|Regression, Linear|||Psychological||||0.789
71003901|NCT03277794|141515552|OTHER|||||||0.811||||||Unadjusted.|Regression, Linear|||Psychological||||0.811
71003902|NCT03277794|141515552|OTHER|||||||0.726||||||Unadjusted.|Regression, Linear|||Social||||0.726
71003903|NCT03277794|141515552|OTHER|||||||0.795||||||Unadjusted.|Regression, Linear|||Social||||0.795
71003904|NCT03277794|141515552|OTHER|||||||0.837||||||Unadjusted.|Regression, Linear|||Environment||||0.837
71003905|NCT03277794|141515552|OTHER|||||||0.048||||||Unadjusted.|Regression, Linear|||Environment||||0.048
71003906|NCT03399786|141515567|SUPERIORITY||Least Squares (LS) Mean Difference|-49.0|STANDARD_ERROR_OF_MEAN|8.0|<|0.0001|TWO_SIDED|95.0|-65.0|-33.1|||Mixed-effect Model Repeat Measure (MMRM)|||Confidence interval (CI) with p-value was based on-treatment group difference of least squares (LS) means using mixed-effect model repeat measurement (MMRM), randomization strata, treatment/strata/baseline value-by-time point interaction and continuous fixed covariates of baseline calculated LDL-C value.||-33.1|-65.0|< 0.0001
71003907|NCT03399786|141515568|SUPERIORITY||Least Squares (LS) Mean Difference|-36.9|STANDARD_ERROR_OF_MEAN|5.9|<|0.0001|TWO_SIDED|95.0|-48.6|-25.2|||Mixed-effect Model Repeat Measure (MMRM)|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. CI with p-value was based on-treatment group difference of LS means using MMRM, randomization strata, treatment/strata/baseline value-by-time point interaction and continuous fixed covariates of baseline calculated Apo B value.||-25.2|-48.6|< 0.0001
71043575|NCT01316419|141596518|SUPERIORITY_OR_OTHER|||||||0.0152|TWO_SIDED|||||The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test|Paired t test|||||||0.0152
71043576|NCT01316419|141596519|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test|Paired t test|||||||0.0013
71003908|NCT03399786|141515569|SUPERIORITY||Least Squares (LS) Mean Difference|-51.7|STANDARD_ERROR_OF_MEAN|6.6|<|0.0001|TWO_SIDED|95.0|-64.8|-38.5|||Mixed-effect Model Repeat Measure (MMRM)|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. CI with p-value was based on-treatment group difference of LS means using MMRM, randomization strata, treatment/strata/baseline value-by-time point interaction and continuous fixed covariates of baseline calculated non-HDL-C value.||-38.5|-64.8|< 0.0001
71003909|NCT03399786|141515570|SUPERIORITY||Least Squares (LS) Mean Difference|-48.4|STANDARD_ERROR_OF_MEAN|5.1|<|0.0001|TWO_SIDED|95.0|-58.7|-38.1|||Mixed-effect Model Repeat Measure (MMRM)|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. CI with p-value was based on-treatment group difference of LS means using MMRM, randomization strata, treatment/strata/baseline value-by-time point interaction and continuous fixed covariates of baseline calculated TC value.||-38.1|-58.7|< 0.0001
71003910|NCT03399786|141515571|SUPERIORITY|A 2-step multiple imputation method addressed missing values (seeds = 1629 \& 9261 with number of imputations = 100 in first and number of imputation=1 in second step).|Odds Ratio (OR)|25.2|||<|0.0001|TWO_SIDED|95.0|5.7|110.5|||Logistic Regression Models Analyses|||A 2-sided hierarchical testing procedure was used for secondary endpoints in pre-specified order to control type I error.Testing sequence continued only when previous endpoint was statistically significant at 0.05.Multiple imputation addressed missing data at week 24.Combined estimate for odds ratio obtained by Rubin's formulae.Logistic regression models stratified by randomized strata include fixed categorical effect of treatment group \& continuous fixed covariate of baseline calculated LDL-C.||110.5|5.7|< 0.0001
71008625|NCT02055976|141525234|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.132|STANDARD_ERROR_OF_MEAN|2.609||0.001|TWO_SIDED|95.0|2.947|13.316|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||13.316|2.947|0.001
71008626|NCT02055976|141525234|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.23|STANDARD_ERROR_OF_MEAN|2.592|<|0.001|TWO_SIDED|95.0|5.079|15.381|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||15.381|5.079|<0.001
71008627|NCT02055976|141525234|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.767|STANDARD_ERROR_OF_MEAN|2.565||0.014|TWO_SIDED|95.0|0.67|10.864|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.864|0.670|0.014
71043577|NCT01316419|141596520|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The change of QOL data collected using the EQ VAS is analyzed by paired t-test|Paired t test|||||||<0.0001
70924671|NCT04321031|141342043|SUPERIORITY||Risk Difference (RD)|-0.07|||||TWO_SIDED|90.0|-0.2|0.03|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.03|-0.20|
70924672|NCT04321031|141342043|SUPERIORITY||Risk Difference (RD)|-0.09|||||TWO_SIDED|90.0|-0.23|0.04|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.04|-0.23|
71003911|NCT03399786|141515572|SUPERIORITY|A 2-step multiple imputation method addressed missing values (seeds = 1629 \& 9261 with number of imputations = 100 in first and number of imputation=1 in second step).|Odds Ratio (OR)|24.2|||=|0.0028|TWO_SIDED|95.0|3.0|195.6|||Logistic Regression Models Analyses|||A 2-sided hierarchical testing procedure was used for secondary endpoints in pre-specified order to control type I error.Testing sequence continued only when previous endpoint was statistically significant at 0.05.Multiple imputation addressed missing data at week 24.Combined estimate for odds ratio obtained by Rubin's formulae.Logistic regression models stratified by randomized strata include fixed categorical effect of treatment group \& continuous fixed covariate of baseline calculated LDL-C.||195.6|3.0|= 0.0028
70924673|NCT04321031|141342043|SUPERIORITY||Risk Difference (RD)|-0.1|||||TWO_SIDED|90.0|-0.26|0.05|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.05|-0.26|
71003912|NCT03399786|141515573|SUPERIORITY||Least Squares (LS) Mean Difference|-132.1|STANDARD_ERROR_OF_MEAN|21.5|<|0.0001|TWO_SIDED|95.0|-175.3|-88.9|||Mixed-effect Model Repeat Measure (MMRM)|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. CI with p-value was based on-treatment group difference of LS means using MMRM, randomization strata, treatment/strata/baseline value-by-time point interaction and continuous fixed covariates of baseline calculated LDL-C value.||-88.9|-175.3|< 0.0001
71003913|NCT03399786|141515574|SUPERIORITY|A 2-step multiple imputation method addressed missing values (seeds = 1629 \& 9261 with number of imputations = 100 in first and number of imputation=1 in second step).|Odds Ratio (OR)|0.1|||=|0.0845|TWO_SIDED|95.0|0.0|1.3|||Logistic Regression Models Analyses|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Combined estimate for odds ratio was obtained by using Rubin's formulae. Logistic regression models stratified the fixed categorical effect of treatment group and the continuous fixed covariate of baseline calculated LDL-C value.||1.3|0|= 0.0845
71003914|NCT03399786|141515575|SUPERIORITY|A 2-step multiple imputation method addressed missing values (seeds = 1629 \& 9261 with number of imputations = 100 in first and number of imputation=1 in second step).|Odds Ratio (OR)|5.7|||=|0.0203|TWO_SIDED|95.0|1.3|24.9||The p-value is nominal for descriptive purpose only due to statistical hypothesis testing terminated previously.|Logistic Regression Models Analyses|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Combined estimate for odds ratio was obtained by using Rubin's formulae. Logistic regression models stratified the fixed categorical effect of treatment group and the continuous fixed covariate of baseline calculated LDL-C value.||24.9|1.3|= 0.0203
71003915|NCT03399786|141515576|SUPERIORITY|A 2-step multiple imputation method addressed missing values (seeds = 1629 \& 9261 with number of imputations = 100 in first and number of imputation=1 in second step).|Odds Ratio (OR)|0.1|||=|0.0004|TWO_SIDED|95.0|0.0|0.3||The p-value is nominal for descriptive purpose only due to statistical hypothesis testing terminated previously.|Logistic Regression Models Analysis|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Combined estimate for odds ratio was obtained by using Rubin's formulae. Logistic regression models stratified the fixed categorical effect of treatment group and the continuous fixed covariate of baseline calculated LDL-C value.||0.3|0.0|= 0.0004
71003916|NCT04507360|141515589|SUPERIORITY||Mean Difference (Final Values)|0.23|||||TWO_SIDED|||||||||"Mean difference in Overall row"||||
71003917|NCT04507360|141515591|SUPERIORITY||Mean Difference (Final Values)|0.96|||||TWO_SIDED|||||||||Mean difference in total score at week 1||||
71003918|NCT04507360|141515591|SUPERIORITY||Mean Difference (Final Values)|0.63|||||TWO_SIDED|||||||||Mean difference in total score at week 2||||
71101188|NCT04204902|141710427|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90 percentage Confidence Interval (CI) as 80.00 percentage - 125.00 percentage|Ratio of Geometric Least Square Mean|104.62|||||TWO_SIDED|90.0|95.17|115.0||||||||115.00|95.17|
71003919|NCT04507360|141515591|SUPERIORITY||Mean Difference (Final Values)|0.19|||||TWO_SIDED|||||||||Mean difference in total score at week 3||||
71003920|NCT04507360|141515591|SUPERIORITY||Mean Difference (Final Values)|0.62|||||TWO_SIDED|||||||||Mean difference in total score at week 4||||
71003921|NCT04507360|141515591|SUPERIORITY||Mean Difference (Final Values)|0.85|||||TWO_SIDED|||||||||Mean difference in total score at week 8||||
71003922|NCT04507360|141515591|SUPERIORITY||Mean Difference (Final Values)|0.41|||||TWO_SIDED|||||||||Mean difference in total score at week 1||||
71003923|NCT04507360|141515591|SUPERIORITY||Mean Difference (Final Values)|1.39|||||TWO_SIDED|||||||||Mean difference in total score at week 2||||
71003924|NCT04507360|141515591|SUPERIORITY||Mean Difference (Final Values)|2.16|||||TWO_SIDED|||||||||Mean difference in total score at week 3||||
71003925|NCT04507360|141515591|SUPERIORITY||Mean Difference (Final Values)|2.69|||||TWO_SIDED|||||||||Mean difference in total score at week 4||||
71003926|NCT04507360|141515591|SUPERIORITY||Mean Difference (Final Values)|1.75|||||TWO_SIDED|||||||||Mean difference in total score at week 8||||
71003927|NCT04507360|141515592|SUPERIORITY||Mean Difference (Final Values)|0.07|||||TWO_SIDED|||||||||Mean difference in total score at week 1||||
71003928|NCT04507360|141515592|SUPERIORITY||Mean Difference (Final Values)|0.42|||||TWO_SIDED|||||||||Mean difference in total score at week 2||||
71003929|NCT04507360|141515592|SUPERIORITY||Mean Difference (Final Values)|0.4|||||TWO_SIDED|||||||||Mean difference in total score at week 3||||
71003930|NCT04507360|141515592|SUPERIORITY||Mean Difference (Final Values)|0.32|||||TWO_SIDED|||||||||Mean difference in total score at week 4||||
71003931|NCT04507360|141515593|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|||||||||Mean difference in total score at week 1||||
71003932|NCT04507360|141515593|SUPERIORITY||Mean Difference (Final Values)|0.37|||||TWO_SIDED|||||||||Mean difference in total score at week 2||||
71003933|NCT04507360|141515593|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|||||||||Mean difference in total score at week 3||||
71003934|NCT04507360|141515593|SUPERIORITY||Mean Difference (Final Values)|0.29|||||TWO_SIDED|||||||||Mean difference in total score at week 4||||
71003935|NCT04507360|141515594|SUPERIORITY||Mean Difference (Final Values)|0.58|||||TWO_SIDED|||||||||Mean difference in total score at week 1||||
71003936|NCT04507360|141515594|SUPERIORITY||Mean Difference (Final Values)|0.08|||||TWO_SIDED|||||||||Mean difference in total score at week 2||||
71003937|NCT04507360|141515594|SUPERIORITY||Mean Difference (Final Values)|1.24|||||TWO_SIDED|||||||||Mean difference in total score at week 3||||
71003938|NCT04507360|141515594|SUPERIORITY||Mean Difference (Final Values)|0.47|||||TWO_SIDED|||||||||Mean difference in total score at week 4||||
71003939|NCT04507360|141515594|SUPERIORITY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|||||||||Mean difference in total score at week 8||||
71003940|NCT04507360|141515594|SUPERIORITY||Mean Difference (Final Values)|1.98|||||TWO_SIDED|||||||||Mean difference in total score at week 1||||
71003941|NCT04507360|141515594|SUPERIORITY||Mean Difference (Final Values)|1.18|||||TWO_SIDED|||||||||Mean difference in total score at week 2||||
71003942|NCT04507360|141515594|SUPERIORITY||Mean Difference (Final Values)|3.67|||||TWO_SIDED|||||||||Mean difference in total score at week 3||||
71003943|NCT04507360|141515594|SUPERIORITY||Mean Difference (Final Values)|4.22|||||TWO_SIDED|||||||||Mean difference in total score at week 4||||
71003944|NCT04507360|141515594|SUPERIORITY||Mean Difference (Final Values)|2.07|||||TWO_SIDED|||||||||Mean difference in total score at week 8||||
71003945|NCT04507360|141515597|SUPERIORITY||Mean Difference (Final Values)|0.31|||||TWO_SIDED|||||||||Mean difference at baseline||||
71003946|NCT04507360|141515597|SUPERIORITY||Mean Difference (Final Values)|0.29|||||TWO_SIDED|||||||||Mean difference at week 1||||
71003947|NCT04507360|141515597|SUPERIORITY||Mean Difference (Final Values)|0.12|||||TWO_SIDED|||||||||Mean difference at week 2||||
71003948|NCT04507360|141515597|SUPERIORITY||Mean Difference (Final Values)|0.13|||||TWO_SIDED|||||||||Mean difference at week 3||||
71003949|NCT04507360|141515597|SUPERIORITY||Mean Difference (Final Values)|1.68|||||TWO_SIDED|||||||||Mean difference at week 4||||
71101189|NCT06091956|141710439|SUPERIORITY|||||||0.008|||||||McNemar|||||||0.008
71101190|NCT06091956|141710440|SUPERIORITY|||||||0.629|||||||Wilcoxon (Mann-Whitney)|||||||0.629
71003950|NCT04507360|141515597|SUPERIORITY||Mean Difference (Final Values)|0.16|||||TWO_SIDED|||||||||Mean difference at week 8||||
71003951|NCT04507360|141515597|SUPERIORITY||Mean Difference (Final Values)|0.28|||||TWO_SIDED|||||||||Mean difference at baseline||||
71003952|NCT04507360|141515597|SUPERIORITY||Mean Difference (Final Values)|0.67|||||TWO_SIDED|||||||||Mean difference at week 1||||
71003953|NCT04507360|141515597|SUPERIORITY||Mean Difference (Final Values)|0.78|||||TWO_SIDED|||||||||Mean difference at week 2||||
71003954|NCT04507360|141515597|SUPERIORITY||Mean Difference (Final Values)|0.18|||||TWO_SIDED|||||||||Mean difference at week 3||||
71003955|NCT04507360|141515597|SUPERIORITY||Mean Difference (Final Values)|0.47|||||TWO_SIDED|||||||||Mean difference at week 4||||
71043578|NCT01316419|141596522|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||Mean LDL-C change from baseline at the last visit will be analyzed by paired t-test|Paired t test|||||||0.0006
71003956|NCT04507360|141515597|SUPERIORITY||Mean Difference (Final Values)|0.24|||||TWO_SIDED|||||||||Mean difference at week 8||||
71003957|NCT04507360|141515598|SUPERIORITY||Mean Difference (Final Values)|0.18|||||TWO_SIDED|||||||||Mean difference at baseline||||
71003958|NCT04507360|141515598|SUPERIORITY||Mean Difference (Final Values)|0.15|||||TWO_SIDED|||||||||Mean difference at week 1||||
71003959|NCT04507360|141515598|SUPERIORITY||Mean Difference (Final Values)|0.23|||||TWO_SIDED|||||||||Mean difference at week 2||||
71003960|NCT04507360|141515598|SUPERIORITY||Mean Difference (Final Values)|0.38|||||TWO_SIDED|||||||||Mean difference at week 3||||
71003961|NCT04507360|141515598|SUPERIORITY||Mean Difference (Final Values)|1.26|||||TWO_SIDED|||||||||Mean difference at week 4||||
71003962|NCT04507360|141515598|SUPERIORITY||Mean Difference (Final Values)|0.26|||||TWO_SIDED|||||||||Mean difference at week 8||||
71003963|NCT04507360|141515598|SUPERIORITY||Mean Difference (Final Values)|0.09|||||TWO_SIDED|||||||||Mean difference at baseline||||
71003964|NCT04507360|141515598|SUPERIORITY||Mean Difference (Final Values)|0.26|||||TWO_SIDED|||||||||Mean difference at week 1||||
71003965|NCT04507360|141515598|SUPERIORITY||Mean Difference (Final Values)|0.05|||||TWO_SIDED|||||||||Mean difference at week 2||||
71003966|NCT04507360|141515598|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|||||||||Mean difference at week 3||||
71003967|NCT04507360|141515598|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|||||||||Mean difference at week 4||||
71003968|NCT04507360|141515598|SUPERIORITY||Mean Difference (Final Values)|0.4|||||TWO_SIDED|||||||||Mean difference at week 8||||
71003969|NCT05724069|141515641|SUPERIORITY||Median Difference (Net)|-0.239|||=|0.1279|TWO_SIDED|95.0|-0.553|0.074|||paired T-test|||Subjects in this analysis are 15 and not 30 (this happens because arms are not mutually exclusive, as explained in previous sections). Each subject can contribute with 0, 1, 2 pairs. Only data that constitute pairs evaluable for primary endpoint are considered in the analysis; the pairs evaluable for primary endpoint were 23.||0.074|-0.553|=0.1279
71003970|NCT03552289|141515649|SUPERIORITY|||||||0.8283|||||||One-sided Z-test|||||||0.8283
71003971|NCT01320033|141515650|SUPERIORITY||Mean Difference (Final Values)|-3.6||||0.006|TWO_SIDED|95.0|-6.1|-1.1|||ANCOVA|||||-1.1|-6.1|0.006
71003972|NCT01320033|141515650|SUPERIORITY||Mean Difference (Final Values)|-2.9||||0.024|TWO_SIDED|95.0|-5.4|-0.4|||ANCOVA|||||-0.4|-5.4|0.024
71043579|NCT01316419|141596523|SUPERIORITY_OR_OTHER|||||||0.4248|TWO_SIDED|||||Mean HDL-C change from baseline at the last visit will be analyzed by paired t-test|Paired t test|||||||0.4248
71043580|NCT01316419|141596524|SUPERIORITY_OR_OTHER|||||||0.5579|TWO_SIDED|||||Mean Triglyceride change from baseline at the last visit will be analyzed by paired t-test|Paired t test|||||||0.5579
71003973|NCT01320033|141515650|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.595|TWO_SIDED|95.0|-3.2|1.8|||ANCOVA|||||1.8|-3.2|0.595
71003974|NCT01250899|141515682|SUPERIORITY_OR_OTHER||Percentage of 12-wk 25(OH)D ≥30ng/mL|70.0|||<|0.05|TWO_SIDED|95.0|60.0|80.0|||Exact binomial||The primary endpoint (mean change in 25(OH)D following 12 weeks of vitamin D repletion in vitamin D insufficient subjects) was dichotomized to success or failure to achieve a week twelve 25(OH)D level ≥30ng/mL.|We predicted that HIV-infected subjects would have a 70% twelve-week repletion success rate compared to 85% among historical controls.Eighty subjects provided 91% power to detect a 12-week repletion rate statistically different than 85% (95% confidence interval (CI) 60%, 80%).||80|60|<0.05
71003975|NCT01536418|141515696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.1|||||TWO_SIDED|95.0|-3.0|19.3||||||||19.3|-3.0|
71003976|NCT01536418|141515697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||||TWO_SIDED|95.0|-5.8|10.8||||||CDAI score (Clinical remission), GSK1605786A, 500 mg QD Vs GSK1605786A, 500 mg BID; at Week 8||10.8|-5.8|
71003977|NCT01536418|141515697|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5.6|||||TWO_SIDED|95.0|-3.0|14.3||||||CDAI score (Clinical remission), GSK1605786A, 500 mg QD Vs GSK1605786A, 500 mg BID; at Week 12||14.3|-3.0|
71003978|NCT01536418|141515697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|||||TWO_SIDED|95.0|-4.6|9.5||||||CDAI score (Clinical remission), GSK1605786A, 500 mg QD Vs GSK1605786A, 500 mg BID; at both Weeks 8 and 12||9.5|-4.6|
71003979|NCT01536418|141515698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|||||TWO_SIDED|95.0|-6.0|15.9||||||CDAI score (Clinical response), GSK1605786A, 500 mg QD Vs GSK1605786A, 500 mg BID at Week 8||15.9|-6.0|
71003980|NCT01536418|141515698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|||||TWO_SIDED|95.0|-1.0|18.7||||||CDAI score (Clinical response), GSK1605786A, 500 mg QD Vs GSK1605786A, 500 mg BID at both Week 8 and Week 12||18.7|-1.0|
71003981|NCT02234050|141515703|SUPERIORITY||Hazard Ratio (HR)|1.42||||0.204|TWO_SIDED|80.0|0.997|2.028|||Regression, Cox|||||2.028|0.997|0.204
71003982|NCT02234050|141515706|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.94|TWO_SIDED|95.0|0.53|1.71|||Regression, Cox|||||1.71|0.53|0.94
71043581|NCT01316419|141596525|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||Mean total cholesterol change from baseline at the last visit will be analyzed by paired t-test|Paired t-test|||||||0.0006
71043582|NCT04039919|141596548|OTHER||Geometric LS Mean ratio|0.785|||||TWO_SIDED|90.0|0.6513|0.9461||||||The log-transformed PK parameters was analyzed by a mixed analysis of variance (ANOVA) with period and treatment as fixed effects and study participant as the random effect. The estimates and confidence intervals are back-transformed after the analysis.||0.9461|0.6513|
71043583|NCT04039919|141596549|OTHER||Geometric LS Mean Ratio|0.8342|||||TWO_SIDED|90.0|0.6999|0.9942||||||The log-transformed PK parameters was analyzed by a mixed ANOVA with period and treatment as fixed effects and study participant as the random effect. The estimates and confidence intervals are back-transformed after the analysis.||0.9942|0.6999|
71101191|NCT06091956|141710443|SUPERIORITY|||||||0.175|||||||Wilcoxon (Mann-Whitney)|||||||0.175
71101192|NCT06091956|141710444|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
71003983|NCT02365506|141515708|SUPERIORITY||Difference in LSM|-7.7|STANDARD_ERROR_OF_MEAN|7.92||0.358|TWO_SIDED|95.0|-26.0|10.5|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|Least Square mean (LSM) and 95% confidence interval (CI) is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||10.5|-26.0|0.358
71043584|NCT02070757|141596588|NON_INFERIORITY|Meropenem minus ceftolozane/tazobactam. For ceftolozane/tazobactam to be non-inferior to meropenem the lower bound of a 2-sided 95% confidence interval (CI) for the difference between treatment groups had to be ≥ -10%.|Difference in Percentage of Participants|1.1|||||TWO_SIDED|95.0|-5.13|7.39|||||The % difference between groups is the weighted proportion difference using MRc stratum weights for diagnosis and age categories. The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference.|||7.39|-5.13|
71003984|NCT02365506|141515708|SUPERIORITY||Difference in LSM|-1.7|STANDARD_ERROR_OF_MEAN|7.96||0.84|TWO_SIDED|95.0|-20.0|16.7|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||16.7|-20.0|0.840
71003985|NCT02365506|141515709|SUPERIORITY||Difference in LSM|-6.0|STANDARD_ERROR_OF_MEAN|5.83||0.338|TWO_SIDED|95.0|-19.8|7.8|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||7.8|-19.8|0.338
71003986|NCT02365506|141515709|SUPERIORITY||Difference in LSM|5.3|STANDARD_ERROR_OF_MEAN|6.21||0.425|TWO_SIDED|95.0|-9.4|19.9|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||19.9|-9.4|0.425
71003987|NCT02365506|141515710|SUPERIORITY||Difference in LSM|-6.5|STANDARD_ERROR_OF_MEAN|4.42||0.174|TWO_SIDED|95.0|-16.5|3.5|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||3.5|-16.5|0.174
71003988|NCT02365506|141515710|SUPERIORITY||Difference in LSM|3.4|STANDARD_ERROR_OF_MEAN|4.28||0.448|TWO_SIDED|95.0|-6.3|13.1|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||13.1|-6.3|0.448
71003989|NCT02365506|141515711|SUPERIORITY||Difference in LSM|8.8|STANDARD_ERROR_OF_MEAN|8.5||0.339|TWO_SIDED|95.0|-12.0|29.6|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||29.6|-12.0|0.339
71003990|NCT02365506|141515711|SUPERIORITY||Difference in LSM|12.8|STANDARD_ERROR_OF_MEAN|8.4||0.178|TWO_SIDED|95.0|-7.7|33.4|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||33.4|-7.7|0.178
71003991|NCT02365506|141515712|SUPERIORITY||Difference in LSM|4.9|STANDARD_ERROR_OF_MEAN|8.03||0.564|TWO_SIDED|95.0|-14.1|23.9|||Mixed Models Analysis|||||23.9|-14.1|0.564
71003992|NCT02365506|141515712|SUPERIORITY||Difference in LSM|2.7|STANDARD_ERROR_OF_MEAN|7.38||0.721|TWO_SIDED|95.0|-14.7|20.2|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||20.2|-14.7|0.721
71003993|NCT00592176|141515716|SUPERIORITY_OR_OTHER|||||||0.83|||||||t-test, 2 sided|||||||0.83
71003994|NCT05505734|141515804|SUPERIORITY||Hazard Ratio (HR)|0.535|||<|0.001|TWO_SIDED|95.0|0.392|0.73||The pre-specified alpha (type I error) at the IA was set at 0.003 for the primary and first secondary endpoint|Regression, Cox|||Hazard ratios, 95% confidence intervals for hazard ratios and p-values are estimated using a Cox regression model with treatment group, pre-study asthma therapy, and number of severe exacerbations in the last 12 months prior to randomization as factors. A hazard ratio less than 1 favors the BDA MDI treatment group.||0.730|0.392|<0.001
71003995|NCT05505734|141515805|SUPERIORITY||Hazard Ratio (HR)|0.539|||<|0.001|TWO_SIDED|95.0|0.397|0.733||The pre-specified alpha (type I error) at the IA was set at 0.003 for the primary and first secondary endpoint|Regression, Cox|||Hazard ratios, 95% confidence intervals for hazard ratios and p-values were estimated using a Cox regression model with treatment group, pre-study asthma therapy, and number of severe exacerbations in the last 12 months prior to randomization as factors. A hazard ratio less than 1 favors the BDA MDI treatment group.||0.733|0.397|<0.001
71003996|NCT05505734|141515806|SUPERIORITY||Hazard Ratio (HR)|0.541|||<|0.001|TWO_SIDED|95.0|0.405|0.724||The pre-specified type I error for secondary endpoints tested at the final DCO was 0.05. A hierarchical testing strategy was employed to control the two-sided Type I error rate for the secondary endpoints, excluding the first secondary endpoint.|Regression, Cox|||Hazard ratios, 95% confidence intervals for hazard ratios and p-values were estimated using a Cox regression model with treatment group, pre-study asthma therapy, and number of severe exacerbations in the last 12 months prior to randomization as factors. A hazard ratio less than 1 favors the BDA MDI treatment group.||0.724|0.405|<0.001
71003997|NCT05505734|141515807|SUPERIORITY||Hazard Ratio (HR)|0.541|||<|0.001|TWO_SIDED|95.0|0.406|0.72||The pre-specified type I error for secondary endpoints tested at the final DCO was 0.05. A hierarchical testing strategy was employed to control the two-sided Type I error rate for the secondary endpoints, excluding the first secondary endpoint.|Regression, Cox|||Hazard ratios, 95% confidence intervals for hazard ratios and p-values were estimated using a Cox regression model with treatment group, pre-study asthma therapy, and number of severe exacerbations in the last 12 months prior to randomization as factors. A hazard ratio less than 1 favors the BDA MDI treatment group.||0.720|0.406|<0.001
71003998|NCT05505734|141515808|SUPERIORITY||Rate Ratio|0.47|||<|0.001|TWO_SIDED|95.0|0.34|0.64||The pre-specified type I error for secondary endpoints tested at the final DCO was 0.05. A hierarchical testing strategy was employed to control the two-sided Type I error rate for the secondary endpoints, excluding the first secondary endpoint.|Negative binomial|||Rates, rate ratios and two-sided p-values were estimated from a negative binomial model with treatment, pre-study asthma therapy, and number of severe exacerbations in the last 12 months prior to randomization as factors. A rate ratio less than 1 favors BDA MDI treatment group.||0.64|0.34|<0.001
71003999|NCT05505734|141515809|SUPERIORITY||Rate Ratio|0.46|||<|0.001|TWO_SIDED|95.0|0.33|0.63||The pre-specified type I error for secondary endpoints tested at the final DCO was 0.05. A hierarchical testing strategy was employed to control the two-sided Type I error rate for the secondary endpoints, excluding the first secondary endpoint.|Negative binomial|||Rates, rate ratios and two-sided p-values were estimated from a negative binomial model with treatment, pre-study asthma therapy, and number of severe exacerbations in the last 12 months prior to randomization as factors. A rate ratio less than 1 favors BDA MDI treatment group.||0.63|0.33|<0.001
71043585|NCT02070757|141596589|NON_INFERIORITY|Clinical Response difference is calculated as ceftolozane/tazobactam minus meropenem. For ceftolozane/tazobactam to be non-inferior to meropenem the lower bound of a 2-sided 95% confidence interval (CI) for the difference between treatment groups had to be ≥ -12.5%.|Difference in percentage of participants|1.1|||||TWO_SIDED|95.0|-6.17|8.29|||||The % difference between groups is the weighted proportion difference using MRc stratum weights for diagnosis and age categories. The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference.|||8.29|-6.17|
71043586|NCT02070757|141596590|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|4.4|||||TWO_SIDED|95.0|-2.83|11.75|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||11.75|-2.83|
71043587|NCT02070757|141596591|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|-1.3|||||TWO_SIDED|95.0|-10.21|7.67|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||7.67|-10.21|
71043588|NCT02070757|141596592|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|7.0||||||95.0|-5.11|18.93|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||18.93|-5.11|
71043589|NCT02070757|141596594|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|-1.4|||||TWO_SIDED|95.0|-6.41|3.57|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||3.57|-6.41|
71043590|NCT02070757|141596595|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|-0.8|||||TWO_SIDED|95.0|-7.67|6.04|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||6.04|-7.67|
71043591|NCT02070757|141596596|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|1.6|||||TWO_SIDED|95.0|-8.91|12.02|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||12.02|-8.91|
71043592|NCT02070757|141596597|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|3.3|||||TWO_SIDED|95.0|-3.38|10.44|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||10.44|-3.38|
71043593|NCT01546922|141596601|SUPERIORITY_OR_OTHER|||||||0.861||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Rivermead Behavioural Memory Test (RBMT) - Immediate memory||||0.861
71043594|NCT01546922|141596601|SUPERIORITY_OR_OTHER|||||||0.668||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||RBMT - Delayed memory||||0.668
71043595|NCT01546922|141596601|SUPERIORITY_OR_OTHER|||||||0.713||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||RBMT-Delayed corrected for immediate memory||||0.713
71004000|NCT05505734|141515810|SUPERIORITY||||||<|0.001||||||The pre-specified type I error for secondary endpoints tested at the final DCO was 0.05. A hierarchical testing strategy was employed to control the two-sided Type I error rate for the secondary endpoints, excluding the first secondary endpoint.|Wilcoxon rank sum|||||||<0.001
71043596|NCT01546922|141596601|SUPERIORITY_OR_OTHER|||||||0.028||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test - Short-term memory||||0.028
71101193|NCT00489476|141710542|SUPERIORITY|||||||0.0212|||||||Fisher Exact|||||||0.0212
71101194|NCT00489476|141710542|SUPERIORITY|||||||0.0106|||||||Fisher Exact|||||||0.0106
71004001|NCT05505734|141515811|SUPERIORITY||||||<|0.001||||||The pre-specified type I error for secondary endpoints tested at the final DCO was 0.05. A hierarchical testing strategy was employed to control the two-sided Type I error rate for the secondary endpoints, excluding the first secondary endpoint.|Wilcoxon rank sum|||||||<0.001
71004002|NCT00435929|141515820|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.656|||||TWO_SIDED|90.0|0.268|1.603||||||Comparison between normal liver function and moderate hepatic impairment for SQV||1.603|0.268|
71004003|NCT00435929|141515820|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.764|||||TWO_SIDED|90.0|0.505|1.156||||||Comparison between normal liver function and moderate hepatic impairment for RTV.||1.156|0.505|
71004004|NCT00435929|141515821|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.716|||||TWO_SIDED|90.0|0.311|1.644||||||Comparison between normal liver function and moderate hepatic impairment for SQV.||1.644|0.311|
71004005|NCT00435929|141515821|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.844|||||TWO_SIDED|90.0|0.551|1.292||||||Comparison between normal liver function and moderate hepatic impairment for RTV.||1.292|0.551|
71004006|NCT00976963|141515842|NON_INFERIORITY|The equivalence margin for non-inferiority of Fosfomycin to TMP/SMX is 10%.|||||<|0.001|||||||Wald test for noninferiority|||The null hypothesis is that Fosfomycin is inferior to TMP/SMX.||||<0.001
71004007|NCT03369704|141515853|OTHER||Least Square Mean|-1.03|STANDARD_ERROR_OF_MEAN|0.209|<|0.001|TWO_SIDED|95.0|-1.44|-0.62||"H0: Omalizumab is not different to placebo with respect to mean nasal symptom score over the severe symptom period.~H1: Omalizumab is different to placebo with respect to mean nasal symptom score over the severe symptom period."|ANCOVA||nasal symptom score|||-0.62|-1.44|<0.001
71004008|NCT03369704|141515854|OTHER||ANCOVA|-1.89|STANDARD_ERROR_OF_MEAN|0.331|||TWO_SIDED|95.0|-2.55|-1.24|||||Nasal Ocular Symptom|||-1.24|-2.55|
71004009|NCT03369704|141515854|OTHER||ANCOVA|-0.87|STANDARD_ERROR_OF_MEAN|0.159|||TWO_SIDED|95.0|-1.18|-0.55|||||Ocular symptom|||-0.55|-1.18|
71004010|NCT03369704|141515855|OTHER||ANCOVA|-1.1|STANDARD_ERROR_OF_MEAN|0.229|||TWO_SIDED|95.0|-1.55|-0.64|||||nasal symptom medication score|||-0.64|-1.55|
71004011|NCT03369704|141515855|OTHER||ANCOVA|-0.95|STANDARD_ERROR_OF_MEAN|0.189|||TWO_SIDED|95.0|-1.32|-0.58|||||ocular symptom medication score|||-0.58|-1.32|
71004012|NCT03369704|141515855|OTHER||ANCOVA|-2.05|STANDARD_ERROR_OF_MEAN|0.375|||TWO_SIDED|95.0|-2.78|-1.31|||||nasal ocular symptom medication score|||-1.31|-2.78|
71004013|NCT03369704|141515856|OTHER||ANCOVA|-0.4|STANDARD_ERROR_OF_MEAN|0.073|||TWO_SIDED|95.0|-0.54|-0.26|||||sneezing score|||-0.26|-0.54|
71004014|NCT03369704|141515856|OTHER||ANCOVA|-0.34|STANDARD_ERROR_OF_MEAN|0.088|||TWO_SIDED|95.0|-0.51|-0.16|||||rhinorrhea score|||-0.16|-0.51|
71004015|NCT03369704|141515856|OTHER||ANCOVA|-0.29|STANDARD_ERROR_OF_MEAN|0.081|||TWO_SIDED|95.0|-0.45|-0.13|||||nasal congestion score|||-0.13|-0.45|
71004016|NCT03369704|141515857|OTHER||ANCOVA|-0.47|STANDARD_ERROR_OF_MEAN|0.084|||TWO_SIDED|95.0|-0.63|-0.3|||||itchy eye score|||-0.30|-0.63|
71004017|NCT03369704|141515857|OTHER||ANCOVA|-0.4|STANDARD_ERROR_OF_MEAN|0.087|||TWO_SIDED|95.0|-0.57|-0.23|||||watery eye score|||-0.23|-0.57|
71004018|NCT03369704|141515858|OTHER||ANCOVA|-0.34|STANDARD_ERROR_OF_MEAN|0.072|||TWO_SIDED|95.0|-0.48|-0.2|||||score for impairment of daily activities|||-0.20|-0.48|
71004019|NCT03369704|141515859|OTHER||Hodges-Lehmann Estimate|3.0|STANDARD_ERROR_OF_MEAN|1.02||0.005|TWO_SIDED|95.0|1.0|5.0|||van Elteren test||Nasal symptom free days|||5.0|1.0|0.005
71004020|NCT03369704|141515859|OTHER||Hodges-Lehmann Estimate|4.0|STANDARD_ERROR_OF_MEAN|1.15|<|0.001|TWO_SIDED|95.0|2.0|6.5|||van Elteren test||Ocular symptom free days|||6.5|2.0|<0.001
71004021|NCT03369704|141515860|OTHER||Odds Ratio (OR)|3.43||||0.005|TWO_SIDED|95.0|1.21|9.75|||logistic regression||Completely nasal symptom free patients|||9.75|1.21|0.005
71004022|NCT03369704|141515861|OTHER||ANCOVA|-0.08|STANDARD_ERROR_OF_MEAN|0.033|||TWO_SIDED|95.0|-0.14|-0.01|||||Nasal rescue mediation score|||-0.01|-0.14|
71004023|NCT03369704|141515861|OTHER||ANCOVA|-0.08|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-0.16|0.0|||||Ocular rescue medication score|||0.00|-0.16|
71004024|NCT03369704|141515861|OTHER||ANCOVA|-0.16|STANDARD_ERROR_OF_MEAN|0.063|||TWO_SIDED|95.0|-0.28|-0.04|||||Nasal ocular rescue medication score|||-0.04|-0.28|
71004025|NCT03369704|141515862|OTHER||Hodges-Lehmann Estimate|1.5|STANDARD_ERROR_OF_MEAN|0.89||0.011|TWO_SIDED|95.0|0.0|3.5|||van Elteren test||Nasal rescue mediation free days|||3.5|0.0|0.011
71004026|NCT03369704|141515862|OTHER||Hodges-Lehmann Estimate|2.0|STANDARD_ERROR_OF_MEAN|1.21||0.074|TWO_SIDED|95.0|0.0|4.8|||van Elteren test||Ocular rescue medication free days|||4.8|0.0|0.074
71004027|NCT03369704|141515862|OTHER||Hodges-Lehmann Estimate|1.8|STANDARD_ERROR_OF_MEAN|1.02||0.098|TWO_SIDED|95.0|0.0|4.0|||van Elteren test||Nasal ocular rescue medication free days|||4.0|0.0|0.098
71004028|NCT03369704|141515863|OTHER||Hodges-Lehmann Estimate|-2.0|STANDARD_ERROR_OF_MEAN|1.15||0.006|TWO_SIDED|95.0|-4.5|0.0|||van Elteren test||Nasal rescue mediation used|||0.0|-4.5|0.006
71004029|NCT03369704|141515863|OTHER||Hodges-Lehmann Estimate|-7.0|STANDARD_ERROR_OF_MEAN|2.81||0.012|TWO_SIDED|95.0|-12.0|-1.0|||van Elteren test||Ocular rescue medication used|||-1.0|-12.0|0.012
71004030|NCT03369704|141515864|OTHER||ANCOVA|-0.5|STANDARD_ERROR_OF_MEAN|0.086|||TWO_SIDED|95.0|-0.66|-0.33|||||JRQLQ I|||-0.33|-0.66|
71004031|NCT03369704|141515864|OTHER||ANCOVA|-0.51|STANDARD_ERROR_OF_MEAN|0.093|||TWO_SIDED|95.0|-0.69|-0.33|||||JRQLQ II|||-0.33|-0.69|
71004032|NCT03369704|141515864|OTHER||ANCOVA|-0.6|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.8|-0.4|||||JRQLQ III|||-0.4|-0.8|
71004033|NCT03236506|141515876|NON_INFERIORITY|Assuming a 95% SVR rate (based on published studies) in the DOT arm of the trial in this population and a non-inferiority limit of 14% (which would be likely to maintain cost-effectiveness) then at a 5% significance level and 90% power we would need a sample size of 42 in each group 126 in total. To allow for drop-outs we will aim to recruit 135 individuals, 45 per group.|Odds Ratio (OR)|0.64||||0.67|TWO_SIDED|95.0|0.14|3.0|||Logistic|||||3.00|0.14|0.67
71004034|NCT03236506|141515876|NON_INFERIORITY|Described in Statistical Analysis 1.|Odds Ratio (OR)|0.53||||0.41|TWO_SIDED|95.0|0.11|2.45|||logistic|||||2.45|0.11|0.41
71004035|NCT03236506|141515876|NON_INFERIORITY|Described in Statistical Analysis 1.|Odds Ratio (OR)|1.22||||0.82|TWO_SIDED|95.0|0.23|6.61|||logistic|||||6.61|0.23|0.82
71004036|NCT03152110|141515906|SUPERIORITY|||||||0.203|||||||t-test, 2 sided|||||||.203
71043597|NCT01546922|141596601|SUPERIORITY_OR_OTHER|||||||0.227||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test - Total immediate memory||||0.227
71004037|NCT03152110|141515907|SUPERIORITY|||||||0.931|||||||t-test, 2 sided|||||||0.931
71004038|NCT02213081|141515931|EQUIVALENCE|Wilcoxon signed rank test was used to determine if the mean difference in pain scores before compared to during ulipristal therapy were equivalent or non-equivalent.|Mean Difference (Net)|3.5|STANDARD_ERROR_OF_MEAN|0.57|<|0.05|TWO_SIDED||||||Wilcoxon signed rank|||||||<0.05
71004039|NCT00085644|141515976|SUPERIORITY_OR_OTHER||Risk Difference (RD)|37.6|||<|0.001||95.0|27.4|47.8|||Chi-squared||Risk difference is measured as a percentage.|ASAS 20 response rates of the adalimumab group were compared with the placebo group using Pearson's Chi-square test. The counts and percentages were calculated for total sample and by therapy group. Statistical tests were 2-sided. For the statistical analysis, subjects with missing data before Week 12 were considered as nonresponders. The comparisons were performed at an alpha level = 0.05.||47.8|27.4|< 0.001
71004040|NCT00085644|141515977|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.985||95.0|||||ANCOVA|||||||0.985
71004041|NCT00893763|141516049|SUPERIORITY_OR_OTHER|||||||0.1763|TWO_SIDED||||||mixed effects linear model|||We compared groups in a single analytical model using a mixed effects linear model with CPIS as the response variable. For this model, group (CHX, control), day, group by day interaction, APACHE III score and hospital (VCU, USF) were modeled as fixed effects and subject was modeled as a random effect.||||0.1763
71004042|NCT00893763|141516049|SUPERIORITY_OR_OTHER|||||||0.8656|TWO_SIDED||||||Regression, Logistic|||A logistic regression analysis was performed using the binary response variable of colonization or no colonization and dependent variables for group, length of intubation, and group-by-length-of-intubation interaction. The probability of a type 1 error ( a ) was set to 0.05.||||0.8656
71004043|NCT01836029|141516072|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99||||0.266|ONE_SIDED|90.0||1.22||The 1-sided p-value based on a log-rank test stratified by randomization stratification factors.|Log Rank|||||1.22||0.266
71004044|NCT01836029|141516074|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.95||||0.399|ONE_SIDED|90.0||1.22||The 1-sided p-value based on a log-rank test stratified by randomization stratification factors.|Log Rank|||||1.22||0.399
71043598|NCT01546922|141596601|SUPERIORITY_OR_OTHER|||||||0.13||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test - Learning Score||||0.130
71043599|NCT01546922|141596601|SUPERIORITY_OR_OTHER|||||||0.106||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test- Delayed memory||||0.106
71043600|NCT01546922|141596601|SUPERIORITY_OR_OTHER|||||||0.35||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test - Delayed corrected for total memory||||0.350
71043601|NCT01546922|141596601|SUPERIORITY_OR_OTHER|||||||0.093||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test - Recognition||||0.093
71043602|NCT01546922|141596601|SUPERIORITY_OR_OTHER|||||||0.614||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Digit Span forward - Short-term memory||||0.614
71043603|NCT01546922|141596601|SUPERIORITY_OR_OTHER|||||||0.111||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Rey Complex Figure - Immediate memory||||0.111
71043604|NCT01546922|141596601|SUPERIORITY_OR_OTHER|||||||0.451||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Rey Complex Figure - Delayed memory||||0.451
71101195|NCT00489476|141710543|SUPERIORITY|||||||0.0123|||||||Fisher Exact|||||||0.0123
71101196|NCT00489476|141710543|SUPERIORITY|||||||0.0228|||||||Fisher Exact|||||||0.0228
71101197|NCT00489476|141710544|SUPERIORITY|||||||0.0409|||||||Fisher Exact|||||||0.0409
71101198|NCT00581100|141710549|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mixed Models Analysis|Adjusted change calculated from mixed-model. Model for change = \[Group visit Group\*visit baseline baseline\*visit\].||||||<0.0001
71043605|NCT01546922|141596601|SUPERIORITY_OR_OTHER|||||||0.905||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Divided attention-Reaction time auditory response||||0.905
71043606|NCT01546922|141596601|SUPERIORITY_OR_OTHER|||||||0.502||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Divided attention-Reaction time visual response||||0.502
71101199|NCT00581100|141710549|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed-model. Model for change = \[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
71101200|NCT00581100|141710550|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mixed Models Analysis|Adjusted change calculated from mixed-model. Model for change = \[Group visit Group\*visit baseline baseline\*visit\].||||||<0.0001
71101201|NCT00581100|141710550|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed-model. Model for change = \[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
71101202|NCT00581100|141710551|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion = \[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
71101203|NCT00581100|141710551|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion = \[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
71101204|NCT00581100|141710551|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion = \[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
71101205|NCT00581100|141710551|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion = \[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
71043607|NCT01546922|141596601|SUPERIORITY_OR_OTHER|||||||0.531||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Divided attention-Number of omission errors||||0.531
71043608|NCT01546922|141596601|SUPERIORITY_OR_OTHER|||||||0.681||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Divided attention-Number of commission errors||||0.681
71043609|NCT01546922|141596601|SUPERIORITY_OR_OTHER|||||||0.713||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Visual scanning - Reaction time for target stimuli||||0.713
71101206|NCT00581100|141710552|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||0.007
71101207|NCT00581100|141710552|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||0.006
71043610|NCT01546922|141596601|SUPERIORITY_OR_OTHER|||||||0.229||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Visual scanning - Number of omission errors||||0.229
71043611|NCT01546922|141596601|SUPERIORITY_OR_OTHER|||||||0.329||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Visual scanning - Number of commission errors||||0.329
71043612|NCT01546922|141596601|SUPERIORITY_OR_OTHER|||||||0.192||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Alertness - Reaction time tonic alertness||||0.192
71043613|NCT01546922|141596601|SUPERIORITY_OR_OTHER|||||||0.164||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Alertness - Reaction time phasic alertness||||0.164
71043614|NCT01546922|141596601|SUPERIORITY_OR_OTHER|||||||0.536||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Semantic fluency||||0.536
71043615|NCT01546922|141596601|SUPERIORITY_OR_OTHER|||||||0.572||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Phonemic fluency||||0.572
71101208|NCT00581100|141710552|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
71101209|NCT00581100|141710552|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
71101210|NCT00581100|141710553|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion =\[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
71101211|NCT00581100|141710553|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion =\[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
71101212|NCT00581100|141710553|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion =\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
71101213|NCT00581100|141710553|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion =\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
71101214|NCT00581100|141710554|SUPERIORITY_OR_OTHER|||||||0.069||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||0.069
71101215|NCT00581100|141710554|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||0.006
71043616|NCT01546922|141596601|SUPERIORITY_OR_OTHER|||||||0.632||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Digit span backward - Working memory||||0.632
71043617|NCT01546922|141596601|SUPERIORITY_OR_OTHER|||||||0.512||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Trail Making Test - Time condition A||||0.512
71043618|NCT01546922|141596601|SUPERIORITY_OR_OTHER|||||||0.861||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Trail Making Test - Time condition B||||0.861
71043619|NCT01546922|141596601|SUPERIORITY_OR_OTHER|||||||0.958||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Trail Making Test - Condition B/A||||0.958
71043620|NCT01546922|141596601|SUPERIORITY_OR_OTHER|||||||0.819||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Social cognition||||0.819
71043621|NCT02551679|141596626|SUPERIORITY||Cox Proportional Hazard|2.046||||0.258|TWO_SIDED|95.0|0.577|7.255|||ANCOVA|||The primary hypothesis of this study is that ACP-01 is superior to placebo in terms of the earlier time from treatment with Investigational Medicinal Product (IMP) to either de-novo gangrene, or doubling of wound size, or major amputation, or death.||7.255|0.577|0.258
71043622|NCT00880087|141596674|SUPERIORITY||Risk Difference (RD)|-2.6||||0.63|TWO_SIDED|95.0|-14.5|9.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was used adjusting for age category at time of randomization (\<2 years, 2 to \<12 years, or \>=12 years)||||9.2|-14.5|0.63
71043623|NCT00880087|141596675|SUPERIORITY||Risk Difference (RD)|2.8||||0.56|TWO_SIDED|95.0|-8.0|13.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was used adjusting for age category at time of randomization (\<2 years, 2 to \<12 years, or \>=12 years)||||13.7|-8.0|0.56
71004045|NCT01836029|141516075|SUPERIORITY_OR_OTHER_LEGACY|||||||0.536||||||p-values are from Cochran-Mantel-Haenszel tests controlling for randomization stratification factors and comparing tumor response rates between the treatment groups.|Cochran-Mantel-Haenszel|||||||0.536
71004046|NCT04157751|141516077|OTHER||Stratified Win Ratio|1.36||||0.0027|TWO_SIDED|95.0|1.09|1.68||p-value for WR\<=1.0 (one-sided), variance calculated using the asymptotic normal U statistics approach.|Asymptotic normal U statistics approach||WR estimate= \[((a)+(c)+(e)+(g)) / ((b)+(d)+(f)+(h))\]|"Stratified win ratio (WR) was used, calculated as total number of wins in the empa group across all strata divided by total number of losses. Weights were applied analogous to a Mantel-Haenszel approach.~1. death in pbo first;~2. death in empa first;~3. HFEs in pbo more frequently;~4. HFEs in empa more frequently;~5. HFEs in pbo first;~6. HFEs in empa first;~7. KCCQ-TSS change lower in pbo;~8. KCCQ-TSS change lower in empa"||1.68|1.09|0.0027
71004047|NCT04157751|141516078|OTHER||Odds Ratio (OR)|1.522|STANDARD_ERROR_OF_MEAN|0.386||0.097|TWO_SIDED|95.0|0.927|2.501||p-value for OR=1.0 (two-sided).|Regression, Logistic|Wald Confidence interval.|Comparison vs. Placebo.|Logistic regression including terms for baseline KCCQ-TSS, treatment and heart failure status||2.501|0.927|0.0970
71004048|NCT04157751|141516079|OTHER||Difference of adjusted mean|4.45|STANDARD_ERROR_OF_MEAN|2.1||0.0347|TWO_SIDED|95.0|0.32|8.59||p-value for difference = 0 (two-sided)|Mixed Models Analysis|||Restricted maximum likelihood estimation based on a mixed-effect model for repeated measures (MMRM) analysis to obtain adjusted means for the treatment effects. This model included discrete fixed effects for treatment group, and heart failure status at each visit and continuous fixed effects for baseline value at each visit. Missing data caused by patient withdrawal or other reasons were handled implicitly by the MMRM approach. Unstructured covariance structure was used.||8.59|0.32|0.0347
71004049|NCT04157751|141516080|OTHER||Adjusted geometric mean ratio|0.9||||0.0176|TWO_SIDED|95.0|0.82|0.98|||ANCOVA|ANCOVA with a discrete fixed effect for heart failure status and a continuous fixed effect for baseline NT-proBNP level.|Comparison vs. Placebo|Area under the curve (AUC) of change from baseline in log-transformed NT-proBNP level over 30 days of treatment was analysed by an analysis of covariance (ANCOVA). NT-proBNP level is regarded as log-normally distributed, therefore values were log-transformed prior to analysis. The linear trapezoidal rule was used to calculate the AUC after the log-transformation had been applied to each value.||0.98|0.82|0.0176
71004050|NCT04157751|141516083|OTHER||Hazard Ratio (HR)|0.71||||0.1241|TWO_SIDED|95.0|0.46|1.1||p-value for HR=1.0 (two sided)|Regression, Cox|Cox proportional hazard model with terms for heart failure status and treatment.|Comparison vs. Placebo.|||1.10|0.46|0.1241
71004051|NCT00062647|141516115|NON_INFERIORITY_OR_EQUIVALENCE|No margin was justified owing to the exploratory nature of the investigation.|Risk Difference (RD)|1.0||||||95.0|-35.5|31.9|||the difference in the 2 eradication rate|Statistical testing was limited to interval estimation (95% CI) of the difference in the 2 eradication rates using the method of Agresti and Caffo.||||31.9|-35.5|
71004052|NCT04445051|141516116|SUPERIORITY||Mean Difference (Final Values)|32.9||||0.01|TWO_SIDED|95.0|8.3|57.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||57.5|8.3|0.010
71004053|NCT04445051|141516116|SUPERIORITY||Mean Difference (Final Values)|34.3||||0.007|TWO_SIDED|95.0|9.8|58.8||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||58.8|9.8|0.007
71004054|NCT04445051|141516116|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.908|TWO_SIDED|95.0|-23.1|25.9||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||25.9|-23.1|0.908
71004055|NCT04445051|141516116|SUPERIORITY||Mean Difference (Final Values)|35.3||||0.006|TWO_SIDED|95.0|10.8|59.8||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||59.8|10.8|0.006
71004056|NCT04445051|141516116|SUPERIORITY||Mean Difference (Final Values)|36.8||||0.005|TWO_SIDED|95.0|11.9|61.8||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||61.8|11.9|0.005
71004057|NCT04445051|141516116|SUPERIORITY||Mean Difference (Final Values)|1.5||||0.899|TWO_SIDED|95.0|-23.3|26.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||26.5|-23.3|0.899
71004058|NCT04445051|141516117|SUPERIORITY||Mean Difference (Final Values)|8.8||||0.665|TWO_SIDED|95.0|-31.9|49.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||49.6|-31.9|0.665
71004059|NCT04445051|141516117|SUPERIORITY||Mean Difference (Final Values)|-18.1||||0.375|TWO_SIDED|95.0|-58.7|22.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||22.4|-58.7|0.375
71004060|NCT04445051|141516117|SUPERIORITY||Mean Difference (Final Values)|-27.0||||0.188|TWO_SIDED|95.0|-67.6|13.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||13.6|-67.6|0.188
71004061|NCT04445051|141516117|SUPERIORITY||Mean Difference (Final Values)|-18.6||||0.361|TWO_SIDED|95.0|-59.3|21.9||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||21.9|-59.3|0.361
71004062|NCT04445051|141516117|SUPERIORITY||Mean Difference (Final Values)|-10.9||||0.6|TWO_SIDED|95.0|-52.3|30.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||30.5|-52.3|0.600
71004063|NCT04445051|141516117|SUPERIORITY||Mean Difference (Final Values)|7.78||||0.707|TWO_SIDED|95.0|-33.5|49.0||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||49.0|-33.5|0.707
71004064|NCT04445051|141516118|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.615|TWO_SIDED|95.0|-1.08|0.65||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.65|-1.08|0.615
71004065|NCT04445051|141516118|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.48|TWO_SIDED|95.0|-1.17|0.56||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.56|-1.17|0.480
71004066|NCT04445051|141516118|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.839|TWO_SIDED|95.0|-0.95|0.77||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.77|-0.95|0.839
71043624|NCT00880087|141596676|SUPERIORITY|||||||0.7|||||||Stratified Mann-Whitney Test|Test stratified by age category (\<2 years, 2 to \<12 years, or \>=12 years), for continuous (NOT categorized as reported above) 1-year change in VABS-II|||As the (nonparametric) comparison treated 1-year deaths as worst possible outcomes and worst possible 1-year VABS-II as next worst possible outcomes, using change in VABS-II for other participants alive at 1 year, no relevant estimation of effect size is possible for this secondary outcome.|||0.70
71043625|NCT00880087|141596677|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|"Test used the continuous (NOT categorized as reported above) neuropsychological scores, with Lowest Possible Score treated as lowest possible value."||||||0.46
71043626|NCT02065713|141596679|SUPERIORITY||||||=|0.026|||||||Wilcoxon (Mann-Whitney)|||||||=0.026
71043627|NCT03614494|141596680|SUPERIORITY||Risk Difference (RD)|31.4|||<|0.0001|TWO_SIDED|95.0|26.2|36.4|||Chi-squared|||||36.4|26.2|<0.0001
71043628|NCT03614494|141596681|SUPERIORITY||Odds Ratio (OR)|0.197||||0.036|TWO_SIDED|95.0|0.021|0.906|||Logistic regression, Firth's bias reduct|||||0.906|0.021|0.036
71043629|NCT00483548|141596682|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.36|STANDARD_ERROR_OF_MEAN|1.37||0.7921||95.0|-3.07|2.34||Due to planned interim analysis of primary endpoint, to control type I error at 2-sided alpha=0.05, a nominal 2-sided p-value ≤0.0476 needed at final analysis to reject the null hypothesis of no treatment effect.|ANCOVA Mixed-effects repeated-measures|No other adjustment made for multiple comparisons since all comparisons, except for single primary comparison, are considered secondary.|Mixed-effects repeated-measures (MMRM) analysis of covariance model: fixed categorical effects of treatment, country, mood stabilizer type, visit, treatment-by-visit interaction, fixed continuous effect of baseline value and subject as random effect.|N=141 per arm (282 total) needed for 85% power for 2-sided alpha=0.05 based on true mean difference=4.0 and standard deviation (SD)=11.0 for primary endpoint. Interim Analysis (IA) planned when 60% of subjects had completed study or discontinued prematurely to assess efficacy (nominal 2-sided p-value less than or equal to \[≤\] 0.0076) or futility (nominal 2-sided p-value greater than or equal to \[≥\] 0.5099).||2.34|-3.07|0.7921
71004067|NCT04445051|141516118|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.894|TWO_SIDED|95.0|-0.92|0.8||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.80|-0.92|0.894
71004068|NCT04445051|141516118|SUPERIORITY||Mean Difference (Final Values)|-0.58||||0.195|TWO_SIDED|95.0|-1.46|0.3||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.30|-1.46|0.195
71043630|NCT00483548|141596683|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.7223||95.0|-0.25|0.36|||ANCOVA Mixed-effects repeated-measures|||Week 6; MMRM analysis of covariance model with fixed categorical effects of treatment, country, type of mood stabilizer, visit, treatment-by-visit interaction, fixed continuous effect of baseline value and subject as random effect.||0.36|-0.25|0.7223
71101216|NCT00581100|141710554|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
71101217|NCT00581100|141710554|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
71004069|NCT04445051|141516118|SUPERIORITY||Mean Difference (Final Values)|-0.52||||0.242|TWO_SIDED|95.0|-1.4|0.36||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.36|-1.40|0.242
71004070|NCT04445051|141516119|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.639|TWO_SIDED|95.0|-1.2|0.74||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.74|-1.20|0.639
71004071|NCT04445051|141516119|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.492|TWO_SIDED|95.0|-1.3|0.63||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.63|-1.30|0.492
71043631|NCT00483548|141596684|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.846||||0.5029||95.0|0.52|1.38|||Regression, Logistic||Odds ratio measures the odds of achieving remission (MADRS total score ≤ 12) from ziprasidone treated subjects versus placebo; a value \> 1 favors ziprasidone.|Week 6; LOCF; Logistic regression model with treatment, country, and type of mood stabilizer.||1.38|0.52|0.5029
71043632|NCT00483548|141596685|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.949||||0.8266||95.0|0.59|1.52|||Regression, Logistic||Odds ratio measures the odds of achieving response (≥ 50 % reduction in MADRS total score) from ziprasidone treated subjects versus placebo; a value \> 1 favors ziprasidone.|Week 6; LOCF; Logistic regression model with treatment, country, and type of mood stabilizer.||1.52|0.59|0.8266
71043633|NCT00483548|141596686|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.939||||0.7924||95.0|0.59|1.5||Logistic regression model with treatment, country, and type of mood stabilizer.|Regression, Logistic|||Week 6; LOCF; Logistic regression model with treatment, country, and type of mood stabilizer.||1.50|0.59|0.7924
71043634|NCT00483548|141596687|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-1.68|STANDARD_ERROR_OF_MEAN|0.89||0.0594||95.0|-3.42|0.07|||ANCOVA|||Week 1; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.07|-3.42|0.0594
71043635|NCT00483548|141596687|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-1.25|STANDARD_ERROR_OF_MEAN|1.03||0.223||95.0|-3.27|0.77|||ANCOVA|||Week 2; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.77|-3.27|0.2230
71043636|NCT00483548|141596687|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.43|STANDARD_ERROR_OF_MEAN|1.09||0.6971||95.0|-2.57|1.72|||ANCOVA|||Week 3; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.72|-2.57|0.6971
71004072|NCT04445051|141516119|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.828|TWO_SIDED|95.0|-1.07|0.86||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.86|-1.07|0.828
71043637|NCT00483548|141596687|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.68|STANDARD_ERROR_OF_MEAN|1.12||0.5485||95.0|-2.89|1.54|||ANCOVA|||Week 4; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.54|-2.89|0.5485
71043638|NCT00483548|141596687|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.25|STANDARD_ERROR_OF_MEAN|1.19||0.8322||95.0|-2.6|2.1|||ANCOVA|||Week 5; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||2.10|-2.60|0.8322
71043639|NCT00483548|141596688|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.12|STANDARD_ERROR_OF_MEAN|0.09||0.1771||95.0|-0.29|0.05|||ANCOVA|||Week 1; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.05|-0.29|0.1771
71043640|NCT00483548|141596688|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.15|STANDARD_ERROR_OF_MEAN|0.11||0.1765||95.0|-0.37|0.07|||ANCOVA|||Week 2; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.07|-0.37|0.1765
71043641|NCT00483548|141596688|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.05|STANDARD_ERROR_OF_MEAN|0.11||0.6765||95.0|-0.27|0.18|||ANCOVA|||Week 3; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.18|-0.27|0.6765
71043642|NCT00483548|141596688|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.977||95.0|-0.24|0.25|||ANCOVA|||Week 4; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.25|-0.24|0.9770
71043643|NCT00483548|141596688|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.04|STANDARD_ERROR_OF_MEAN|0.13||0.7907||95.0|-0.3|0.23|||ANCOVA|||Week 5; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.23|-0.30|0.7907
71043644|NCT00483548|141596689|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.0392||95.0|-0.43|-0.01|||ANOVA|||Week 1; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.||-0.01|-0.43|0.0392
71043645|NCT00483548|141596689|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.14|STANDARD_ERROR_OF_MEAN|0.13||0.2803||95.0|-0.38|0.11|||ANOVA|||Week 2; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.||0.11|-0.38|0.2803
71043646|NCT00483548|141596689|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.13||0.9835||95.0|-0.26|0.26|||ANOVA|||Week 3; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.||0.26|-0.26|0.9835
71043647|NCT00483548|141596689|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.06|STANDARD_ERROR_OF_MEAN|0.15||0.7062||95.0|-0.34|0.23|||ANOVA|||Week 4; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.||0.23|-0.34|0.7062
71004073|NCT04445051|141516119|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.744|TWO_SIDED|95.0|-0.81|1.13||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.13|-0.81|0.744
71004074|NCT04445051|141516119|SUPERIORITY||Mean Difference (Final Values)|-0.63||||0.208|TWO_SIDED|95.0|-1.62|0.36||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.36|-1.62|0.208
71004075|NCT04445051|141516119|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.116|TWO_SIDED|95.0|-1.77|0.2||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.20|-1.77|0.116
71004076|NCT04445051|141516120|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.798|TWO_SIDED|95.0|-0.75|0.96||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.96|-0.75|0.798
71101218|NCT00581100|141710555|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change=\[Group visit group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
71004077|NCT04445051|141516120|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.556|TWO_SIDED|95.0|-1.1|0.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.60|-1.10|0.556
71004078|NCT04445051|141516120|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.399|TWO_SIDED|95.0|-1.21|0.49||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.49|-1.21|0.399
71004079|NCT04445051|141516120|SUPERIORITY||Mean Difference (Final Values)|0.55||||0.198|TWO_SIDED|95.0|-0.3|1.41||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.41|-0.30|0.198
71043648|NCT00483548|141596689|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.01|STANDARD_ERROR_OF_MEAN|0.15||0.9518||95.0|-0.31|0.29|||ANOVA|||Week 5; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.||0.29|-0.31|0.9518
71043649|NCT00483548|141596689|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.11|STANDARD_ERROR_OF_MEAN|0.16||0.4757||95.0|-0.2|0.42||Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.|ANOVA|||Week 6; LOCF||0.42|-0.20|0.4757
71043650|NCT00483548|141596690|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.35|STANDARD_ERROR_OF_MEAN|0.75||0.6362||95.0|-1.12|1.82|||ANCOVA|||Week 2; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.82|-1.12|0.6362
71043651|NCT00483548|141596690|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.59|STANDARD_ERROR_OF_MEAN|0.8||0.4565||95.0|-0.98|2.17|||ANCOVA|||Week 4; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||2.17|-0.98|0.4565
71043652|NCT00483548|141596690|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.61|STANDARD_ERROR_OF_MEAN|0.86||0.477||95.0|-1.08|2.3|||ANCOVA|||Week 6; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||2.30|-1.08|0.4770
71043653|NCT00483548|141596691|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.7|STANDARD_ERROR_OF_MEAN|0.46||0.1277||95.0|-0.2|1.6|||ANCOVA|||Week 1; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.60|-0.20|0.1277
71043654|NCT00483548|141596691|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.64|STANDARD_ERROR_OF_MEAN|0.53||0.2345||95.0|-0.41|1.68|||ANCOVA|||Week 2; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.68|-0.41|0.2345
71043655|NCT00483548|141596691|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.13|STANDARD_ERROR_OF_MEAN|0.6||0.8337||95.0|-1.05|1.3|||ANCOVA|||Week 3; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.30|-1.05|0.8337
71043656|NCT00483548|141596691|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.43|STANDARD_ERROR_OF_MEAN|0.59||0.4646||95.0|-0.73|1.59|||ANCOVA|||Week 4; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.59|-0.73|0.4646
71043657|NCT00483548|141596691|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.5|STANDARD_ERROR_OF_MEAN|0.59||0.3993||95.0|-0.67|1.67|||ANCOVA|||Week 5; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.67|-0.67|0.3993
71043658|NCT00483548|141596691|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.19|STANDARD_ERROR_OF_MEAN|0.65||0.7647||95.0|-1.08|1.46|||ANCOVA|||Week 6; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.46|-1.08|0.7647
71043659|NCT00483548|141596692|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|4.24|STANDARD_ERROR_OF_MEAN|1.65||0.0108||95.0|0.99|7.5|||ANCOVA|||Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||7.50|0.99|0.0108
71043660|NCT00483548|141596693|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-4.56|STANDARD_ERROR_OF_MEAN|1.35||0.001||95.0|-7.24|-1.87|||ANCOVA|||Total SDS: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||-1.87|-7.24|0.0010
71043661|NCT00483548|141596694|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.44|STANDARD_ERROR_OF_MEAN|0.28||0.123|TWO_SIDED|95.0|-1.0|0.12|||ANCOVA|||Days Lost: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.12|-1.00|0.1230
71043662|NCT00483548|141596694|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.17|STANDARD_ERROR_OF_MEAN|0.34||0.6232|TWO_SIDED|95.0|-0.84|0.5|||ANCOVA|||Days Unproductive: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.50|-0.84|0.6232
70924674|NCT04321031|141342044|SUPERIORITY||Risk Difference (RD)|-0.07|||||TWO_SIDED|90.0|-0.21|0.13||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.13|-0.21|
71043663|NCT00483548|141596695|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.17|STANDARD_ERROR_OF_MEAN|0.07||0.0096||95.0|0.04|0.31|||ANCOVA|||Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.31|0.04|0.0096
71043664|NCT00483548|141596695|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.8134||95.0|-0.13|0.16|||ANCOVA|||Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.16|-0.13|0.8134
71043665|NCT00483548|141596695|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.16|STANDARD_ERROR_OF_MEAN|0.07||0.0226||95.0|0.02|0.29|||ANCOVA|||Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.29|0.02|0.0226
71043666|NCT00483548|141596696|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0193||95.0|0.02|0.23|||ANCOVA|||Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.23|0.02|0.0193
71043667|NCT00483548|141596696|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.4745||0.16|-0.07|0.16|||ANCOVA|||Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.16|-0.07|0.4745
71043668|NCT00483548|141596696|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.07|STANDARD_ERROR_OF_MEAN|0.06||0.2613||95.0|-0.05|0.19|||ANCOVA|||Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.19|-0.05|0.2613
71043669|NCT00483548|141596697|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.11|STANDARD_ERROR_OF_MEAN|0.05||0.0271||95.0|0.01|0.21|||ANCOVA|||Total score: Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.21|0.01|0.0271
71043670|NCT00483548|141596697|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.7462||95.0|-0.07|0.05|||ANCOVA|||Total score: Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.05|-0.07|0.7462
71043671|NCT00483548|141596697|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.04||0.9574||95.0|-0.08|0.08|||ANCOVA|||Total score: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.08|-0.08|0.9574
71043672|NCT00483548|141596697|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.0844||95.0|-0.01|0.1|||ANCOVA|||Global severity score: Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.10|-0.01|0.0844
71043673|NCT00483548|141596697|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.5779||95.0|-0.04|0.06|||ANCOVA|||Global severity score: Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.06|-0.04|0.5779
71043674|NCT00483548|141596697|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.7455||95.0|-0.05|0.06|||ANCOVA|||Global severity score: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.06|-0.05|0.7455
71043675|NCT00483548|141596697|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.3278||95.0|-0.02|0.05|||ANCOVA|||Incapacitation score: Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.05|-0.02|0.3278
71043676|NCT00483548|141596697|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.9097||95.0|-0.03|0.03|||ANCOVA|||Incapacitation score: Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.03|-0.03|0.9097
71043677|NCT00483548|141596697|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.9864||95.0|-0.04|0.04|||ANCOVA|||Incapacitation score: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.04|-0.04|0.9864
71043678|NCT00483548|141596698|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|1.52|STANDARD_ERROR_OF_MEAN|2.54||0.5519||95.0|-3.5|6.53|||ANCOVA|||Total Q-LES-Q: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||6.53|-3.50|0.5519
71043679|NCT00483548|141596698|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.09|STANDARD_ERROR_OF_MEAN|0.13||0.5238||95.0|-0.35|0.18|||ANCOVA|||Medications: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.18|-0.35|0.5238
71043680|NCT00483548|141596698|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.09|STANDARD_ERROR_OF_MEAN|0.14||0.536||95.0|-0.19|0.36|||ANCOVA|||Overall life satisfaction: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.36|-0.19|0.5360
71101219|NCT00581100|141710555|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change=\[Group visit group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
71043681|NCT00572039|141596730|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.079||||0.47|TWO_SIDED|95.0|-0.14|0.29|||ANCOVA|||To test the efficacy of PST to improve TVF functional reserve measures at 3 months, we used an analysis of covariance in which group differences (PST vs ST) in 3-month average TVF scores were examined, adjusting for baseline TVF score and the vision severity stratification variable. To approximate an interval scale and compensate for ceiling and floor effects, we linearized TVF scores using a logit transform. 106 PST and 112 ST participants provided data at 3 months.||0.29|-0.14|.47
71043682|NCT00572039|141596731|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.4||||0.7|TWO_SIDED|95.0|-1.96|2.77|||ANCOVA|||To test the efficacy of PST to improve NE-VFQ scores at 3 months, we used an analysis of covariance in which group differences (PST vs ST) in 3-month average NEI-VFQ scores were examined, adjusting for baseline score and the vision severity stratification variable.||2.77|-1.96|.7
70924675|NCT04321031|141342044|SUPERIORITY||Risk Difference (RD)|-0.14|||||TWO_SIDED|90.0|-0.25|0.02||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.02|-0.25|
70924676|NCT04321031|141342044|SUPERIORITY||Risk Difference (RD)|-0.02|||||TWO_SIDED|90.0|-0.17|0.17||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.17|-0.17|
70924677|NCT04321031|141342044|SUPERIORITY||Risk Difference (RD)|0.02|||||TWO_SIDED|90.0|-0.15|0.22||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.22|-0.15|
70924678|NCT04321031|141342044|SUPERIORITY||Risk Difference (RD)|-0.22|||||TWO_SIDED|90.0|-0.3|-0.05||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||-0.05|-0.30|
70924679|NCT04321031|141342044|SUPERIORITY||Risk Difference (RD)|0.05|||||TWO_SIDED|90.0|-0.13|0.26||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.26|-0.13|
70924680|NCT04321031|141342044|SUPERIORITY||Risk Difference (RD)|0.04|||||TWO_SIDED|50.0|-0.03|0.12||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.12|-0.03|
71043683|NCT03852524|141596734|SUPERIORITY||Median Difference (Net)|11.0||||0.81|TWO_SIDED||||||Log Rank|||The sample size (41 patients per study group; 82 patients total) for this superiority trial was calculated with a power of 90% (alpha = 0.05) and based on the assumption that 50% of subjects in the placebo group would experience a bowel movement by postoperative day 3, as compared to 85% in the treatment group. Additionally, a 10% lost-to-follow up rate was assumed.||||0.81
71043684|NCT01439724|141596812|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.158||||0.05|TWO_SIDED|95.0|0.05|0.498|||Chi-squared|||The primary end point of the study was the incidence of grade 3-4 oral mucositis (OM) according to the WHO scale. Assuming an α =0.05 and a β = 0.20, with the estimates of proportion being 0.40 for placebo (P0) and 0.15 for LLLT (P1) a total of 94 patients were evaluated. One-sided test error was the basis for the sample size determination and all the reported P-values were derived from two-sided statistical tests. P-values less than or equal to 0.05 were considered statistically significant.||0.498|0.050|0.05
71043685|NCT01040793|141596815|SUPERIORITY_OR_OTHER||Ratio to placebo|1.118|STANDARD_ERROR_OF_MEAN|0.04||0.0018||95.0|1.043|1.199|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline endurance time and period as fixed and patient as random effect. Means, CI back-transformed.|Olo 5 mcg divided by Placebo|||1.199|1.043|0.0018
71043686|NCT01040793|141596815|SUPERIORITY_OR_OTHER||Ratio to placebo|1.105|STANDARD_ERROR_OF_MEAN|0.039||0.0052||95.0|1.03|1.184|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline endurance time and period as fixed and patient as random effect. Means, CI back-transformed.|Olo 10 mcg divided by Placebo|||1.184|1.030|0.0052
71043687|NCT01040793|141596816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.035||0.0155||95.0|0.016|0.152|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.152|0.016|0.0155
71043688|NCT01040793|141596816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.098|0.234|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.234|0.098|<0.0001
70924681|NCT04321031|141342044|SUPERIORITY||Risk Difference (RD)|0.04|||||TWO_SIDED|90.0|-0.12|0.23||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.23|-0.12|
71043689|NCT01040793|141596817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.366|STANDARD_ERROR_OF_MEAN|0.214||0.1176||95.0|-0.757|0.085|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.085|-0.757|0.1176
71043690|NCT01040793|141596817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.066|STANDARD_ERROR_OF_MEAN|0.214||0.7591||95.0|-0.486|0.355|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.355|-0.486|0.7591
71004080|NCT04445051|141516120|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.365|TWO_SIDED|95.0|-1.27|0.48||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.48|-1.27|0.365
71004081|NCT04445051|141516120|SUPERIORITY||Mean Difference (Final Values)|-0.95||||0.033|TWO_SIDED|95.0|-1.82|-0.08||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||-0.08|-1.82|0.033
71004082|NCT04445051|141516121|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.882|TWO_SIDED|95.0|-0.83|0.96||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.96|-0.83|0.882
71004083|NCT04445051|141516121|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.478|TWO_SIDED|95.0|-1.21|0.57||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.57|-1.21|0.478
71101220|NCT00581100|141710556|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
71101221|NCT00581100|141710556|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
71101222|NCT00581100|141710556|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
71101223|NCT00581100|141710556|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
71101224|NCT00581100|141710557|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
71101225|NCT00581100|141710557|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
71101226|NCT00581100|141710557|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
71101227|NCT00581100|141710557|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
71101228|NCT00581100|141710558|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change-\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
71101229|NCT00581100|141710558|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change-\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
71101230|NCT00581100|141710559|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||||||<0.001
71101231|NCT00581100|141710559|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||||||<0.001
71101232|NCT00581100|141710560|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||||||<0.001
71101233|NCT00581100|141710560|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||||||<0.001
71101234|NCT00581100|141710561|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed-model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
70924682|NCT04321031|141342044|SUPERIORITY||Risk Difference (RD)|0.27|||||TWO_SIDED|50.0|0.17|0.38||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.38|0.17|
71004084|NCT04445051|141516121|SUPERIORITY||Mean Difference (Final Values)|-0.38||||0.391|TWO_SIDED|95.0|-1.27|0.51||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.51|-1.27|0.391
71004085|NCT04445051|141516121|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.657|TWO_SIDED|95.0|-0.69|1.09||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.09|-0.69|0.657
71004086|NCT04445051|141516121|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.125|TWO_SIDED|95.0|-1.62|0.2||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.20|-1.62|0.125
71004087|NCT04445051|141516121|SUPERIORITY||Mean Difference (Final Values)|-0.91||||0.051|TWO_SIDED|95.0|-1.81|0.0||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.00|-1.81|0.051
71004088|NCT04445051|141516122|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.877|TWO_SIDED|95.0|-0.83|0.97||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.97|-0.83|0.877
71004089|NCT04445051|141516122|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.351|TWO_SIDED|95.0|-1.31|0.47||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.47|-1.31|0.351
71004090|NCT04445051|141516122|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.278|TWO_SIDED|95.0|-1.38|0.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.40|-1.38|0.278
71004091|NCT04445051|141516122|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.711|TWO_SIDED|95.0|-0.73|1.06||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.06|-0.73|0.711
71004092|NCT04445051|141516122|SUPERIORITY||Mean Difference (Final Values)|-1.06||||0.024|TWO_SIDED|95.0|-1.97|-0.15||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||-0.15|-1.97|0.024
71004093|NCT04445051|141516122|SUPERIORITY||Mean Difference (Final Values)|-1.23||||0.009|TWO_SIDED|95.0|-2.14|-0.31||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||-0.31|-2.14|0.009
71043691|NCT01040793|141596818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.094|0.234|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.234|0.094|<0.0001
71043692|NCT01040793|141596818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.195|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.125|0.265|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.265|0.125|<0.0001
71043693|NCT01040793|141596819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|STANDARD_ERROR_OF_MEAN|0.034||0.0245||95.0|0.01|0.146|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.146|0.010|0.0245
71004094|NCT00997555|141516159|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Chi-squared|||||||0.6
71004095|NCT00997555|141516160|SUPERIORITY_OR_OTHER|||||||0.7||95.0||||(bronchoscopy 5.1 days, 95% CI +/- 3.6 days versus control 6.7 days, 95% CI +/- 6.3 days, p = 0.7).|t-test, 2 sided|||||||0.7
71004096|NCT00997555|141516161|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||t-test, 2 sided|(bronchoscopy 10 days, 95% CI +/- 10 days versus control 18 days, 95% CI +/- 12 days, p = 0.4).||||||0.4
71004097|NCT00997555|141516162|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||t-test, 2 sided|(bronchoscopy 21 days, 95% CI +/- 12 days versus control 26 days, 95% CI +/- 12 days, p = 0.5).||||||0.5
71004098|NCT00901394|141516163|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||For baseline comparisons among the three groups, one-way ANOVA was used for normally distributed variables and χ2 goodness-of-fit for categorical variables. To model the effects of B-vitamin treatment on nitrous-oxide-induced total homocysteine increase at the three different timepoints within individual patients and between the three groups, a linear mixed model with was used and we included a group × time interaction in the model.||||<0.05
71004099|NCT02422186|141516164|SUPERIORITY||Difference of Least Square (LS) Means|-3.6|||=|0.059|TWO_SIDED|95.0|-7.2|0.07|||Mixed Model for Repeated Measures|||||0.07|-7.20|=0.059
71043694|NCT01040793|141596819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.105|0.24|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.240|0.105|<0.0001
71043695|NCT01040793|141596820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.074|STANDARD_ERROR_OF_MEAN|0.07||0.2897||95.0|-0.211|0.063|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.063|-0.211|0.2897
71101235|NCT00581100|141710561|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed-model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
71004100|NCT02422186|141516165|OTHER||Least Square (LS) Mean Difference|-3.6|||=|0.052|TWO_SIDED|95.0|-7.16|-0.03|||ANCOVA|||||-0.03|-7.16|=0.052
71004101|NCT00400946|141516272|SUPERIORITY|||||||0.6|||||||Fisher Exact|||||||.60
71043696|NCT01040793|141596820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025|STANDARD_ERROR_OF_MEAN|0.069||0.7199||95.0|-0.162|0.112|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.112|-0.162|0.7199
71043697|NCT01040793|141596821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.146||0.5313||95.0|-0.196|0.379|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.379|-0.196|0.5313
71043698|NCT01040793|141596821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.341|STANDARD_ERROR_OF_MEAN|0.146||0.0198||95.0|0.055|0.628|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.628|0.055|0.0198
71043699|NCT01040793|141596822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.086|STANDARD_ERROR_OF_MEAN|0.053||0.1048||95.0|-0.19|0.018|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.018|-0.190|0.1048
71043700|NCT01040793|141596822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.053||0.0246||95.0|-0.224|-0.015|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||-0.015|-0.224|0.0246
71043701|NCT01040793|141596823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.213|STANDARD_ERROR_OF_MEAN|0.053|<|0.0001||95.0|-0.318|-0.108|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||-0.108|-0.318|<0.0001
71043702|NCT01040793|141596823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.187|STANDARD_ERROR_OF_MEAN|0.054||0.0005||95.0|-0.293|-0.082|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||-0.082|-0.293|0.0005
71043703|NCT01040793|141596824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.04||0.0002||95.0|0.071|0.228|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.228|0.071|0.0002
71043704|NCT01040793|141596824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.04||0.0001||95.0|0.076|0.233|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.233|0.076|0.0001
71043705|NCT01040793|141596825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.162|0.303|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.303|0.162|<0.0001
71008628|NCT02055976|141525235|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.079|STANDARD_ERROR_OF_MEAN|1.905|<|0.001|TWO_SIDED|95.0|2.296|9.863|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.863|2.296|<0.001
71043706|NCT01040793|141596825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.133|0.273|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.273|0.133|<0.0001
71043707|NCT01040793|141596826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.056||0.3109||95.0|-0.053|0.166|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.166|-0.053|0.3109
71043708|NCT01040793|141596826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.029|STANDARD_ERROR_OF_MEAN|0.056||0.608||95.0|-0.081|0.138|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.138|-0.081|0.6080
71043709|NCT01040793|141596827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.056||0.6809||95.0|-0.087|0.133|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.133|-0.087|0.6809
71043710|NCT01040793|141596827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.056||0.858||95.0|-0.1|0.12|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.120|-0.100|0.8580
71043711|NCT01040793|141596828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.073|0.148|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.148|0.073|<0.0001
71043712|NCT01040793|141596828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.073|0.148|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.148|0.073|<0.0001
71101236|NCT00581100|141710562|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
71101237|NCT00581100|141710562|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
71004102|NCT01673373|141516291|OTHER|Due to the early termination of enrollment, all inferential analyses were interpreted as descriptive and carried out in an exploratory manner.|||||<|0.0001||||||The p-value was computed using a one-sided exact test of the difference between the observed rate and the Performance Goal (equal to 70%). The defined threshold for statistical significance is .025.|one-sided exact|||The original Performance Goal of 70% patency rate was derived from a thorough literature review of trials with renal bare metal stent placement. Other assumptions included a determination of samples size based upon a one-sided alpha of 0.025 and desired power of 87%, and assumption of 10% attrition. The null hypothesis was that the incidence of primary patency at 9 months is less than or equal to 70%.|"The cumulative incidence of primary patency was computed as the number of subject-lesions with primary patency at 9 months divided by the number of subject-lesions and was analyzed using the allowable window of 243 to 303 trial days.~An exact binomial one-sided 95% CI was constructed and the lower limit compared to the Performance Goal equal to 70%."|||<.0001
71004103|NCT01673373|141516292|OTHER|A one-sided 95% Confidence Interval for the mean difference between baseline and 9-month systolic blood pressure was constructed and the lower limit compared to the 10 mmHg performance goal. A p-value of the difference between the estimated systolic blood pressure change from the baseline and the performance goal was computed using a paired t-test.||||||0.0192||||||The defined threshold for statistical significance is .025.|t-test, 1 sided|||The primary endpoint of systolic blood pressure was analyzed according to the Performance Goal of a decrease in systolic blood pressure of 10 mmHg between procedure and 9 months.||||.0192
71004104|NCT05426460|141516304|SUPERIORITY|||||||0.438|||||||ANOVA|||2 x 2 ANOVA||||.438
71004105|NCT05426460|141516305|SUPERIORITY|||||||0.847|||||||ANOVA|||2 x 2 ANOVA||||.847
71004106|NCT05426460|141516306|SUPERIORITY|||||||0.57|||||||ANOVA|||2 X 2 ANOVA||||.570
71004107|NCT05426460|141516307|SUPERIORITY|||||||0.657|||||||ANOVA|||2 x 2 ANOVA||||.657
71043713|NCT01040793|141596829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.151|0.233|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.233|0.151|<0.0001
71043714|NCT01040793|141596829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.195|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.153|0.236|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.236|0.153|<0.0001
71043715|NCT01040793|141596830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.036||0.0013||95.0|0.047|0.191|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.191|0.047|0.0013
71043716|NCT01040793|141596830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.037||0.0013||95.0|0.047|0.191|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.191|0.047|0.0013
71043717|NCT01040793|141596831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.196|0.333|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.333|0.196|<0.0001
71043718|NCT01040793|141596831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.281|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.212|0.35|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.350|0.212|<0.0001
71004108|NCT05426460|141516308|SUPERIORITY|||||||0.254|||||||ANOVA|||2 x 2 ANOVA||||.254
71004109|NCT05426460|141516309|SUPERIORITY|||||||0.852|||||||ANOVA|||2 x 2 ANOVA with Main effect p-values for tDCS and AAT reported in comments below||||.852
71004110|NCT05426460|141516310|SUPERIORITY|||||||0.732|||||||ANOVA|||2 x 2 ANOVA||||.732
71004111|NCT05426460|141516311|SUPERIORITY|||||||0.038|||||||ANOVA|||2 x 2 ANOVA||||.038
71004112|NCT05426460|141516312|SUPERIORITY|||||||0.029|||||||ANOVA|||2 x 2 ANOVA||||.029
71004113|NCT05426460|141516313|SUPERIORITY|||||||0.353|||||||ANOVA|||2 x 2 ANOVA||||.353
71004114|NCT01431521|141516318|SUPERIORITY_OR_OTHER||Least squares mean difference|-44.37|||<|0.001|TWO_SIDED|95.0|-54.67|-34.07|||Linear mixed effects model|Treatment as fixed factor and predose Day 1 value, as a fixed covariate||||-34.07|-54.67|<0.001
71004115|NCT01431521|141516318|SUPERIORITY_OR_OTHER||Least squares mean difference|-26.67|||<|0.001|TWO_SIDED|95.0|-36.97|-16.37|||Linear mixed effects model|Treatment as fixed factor and predose Day 1 value, as a fixed covariate||||-16.37|-36.97|<0.001
71004116|NCT01431521|141516318|SUPERIORITY_OR_OTHER||least squares mean difference|-17.69||||0.007|TWO_SIDED|95.0|-36.97|-7.39|||Linear mixed effects model|Treatment as fixed factor and predose Day 1 value, as a fixed covariate||||-7.39|-36.97|0.007
71043719|NCT01040793|141596832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.281|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.156|0.405|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.405|0.156|<0.0001
71043720|NCT01040793|141596832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.291|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.166|0.416|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.416|0.166|<0.0001
71043721|NCT01040793|141596833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|0.441|0.719|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.719|0.441|<0.0001
71043722|NCT01040793|141596833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.552|STANDARD_ERROR_OF_MEAN|0.071|<|0.0001||95.0|0.412|0.691|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.691|0.412|<0.0001
71004117|NCT01431521|141516319|SUPERIORITY_OR_OTHER||Least square mean difference|-6.35|||>|0.2|TWO_SIDED|95.0|-18.69|6.0|||Linear mixed effect model|Containing fixed effects for treatment, and predose Day 1 (baseline) as a fixed covariate||||6.00|-18.69|>0.200
71004118|NCT01431521|141516319|SUPERIORITY_OR_OTHER||Least squares mean difference|-16.74||||0.028|TWO_SIDED|95.0|-29.08|-4.4|||Linear mixed effects model|Containing fixed effects for treatment, and predose Day 1 (baseline) as a fixed covariate||||-4.40|-29.08|0.028
71004119|NCT01431521|141516320|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.47|||>|0.2|TWO_SIDED|95.0|-17.85|10.92|||Linear mixed effects model|Containing fixed effects for treatment, and predose Day 1 (baseline) as a fixed covariate||||10.92|-17.85|>0.200
71004120|NCT01431521|141516320|SUPERIORITY_OR_OTHER||Least squares mean difference|-10.67|||>|0.2|TWO_SIDED|95.0|-25.06|3.71|||Linear mixed effects model|Containing fixed effects for treatment, and predose Day 1 (baseline) as a fixed covariate||||3.71|-25.06|>0.200
71004121|NCT05171816|141516420|OTHER|Exploratory|Hazard Ratio (HR)|1.43||||0.2592|TWO_SIDED|95.0|0.83|2.48||Nominal p-value|Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by metastases.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||2.48|0.83|0.2592
71004122|NCT05171816|141516421|OTHER|Exploratory|Hazard Ratio (HR)|1.14||||0.7251|TWO_SIDED|95.0|0.57|2.29||Nominal p-value|Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by metastases.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||2.29|0.57|0.7251
71004123|NCT05171816|141516422|OTHER|Exploratory|Hazard Ratio (HR)|0.99||||0.9715|TWO_SIDED|95.0|0.6|1.64||Nominal p-value|Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by metastases.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||1.64|0.60|0.9715
71004124|NCT05171816|141516423|OTHER|Exploratory|Hazard Ratio (HR)|0.68||||0.4937|TWO_SIDED|95.0|0.2|2.06||Nominal p-value|Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by metastases.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||2.06|0.20|0.4937
71043723|NCT03297294|141596848|SUPERIORITY|at week 12|least squares mean|-0.6|STANDARD_ERROR_OF_MEAN|0.39||0.101|TWO_SIDED|95.0|-1.4|0.1|||ANCOVA|||||0.1|-1.4|0.101
71043724|NCT03297294|141596849|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.38||0.168|TWO_SIDED|95.0|-1.3|0.2|||ANCOVA|||At week 12||0.2|-1.3|0.168
71043725|NCT03297294|141596853|SUPERIORITY||Odds Ratio (OR)|1.6||||0.255|TWO_SIDED|95.0|0.7|3.9|||Regression, Logistic|||Week 12||3.9|0.7|0.255
71043726|NCT03297294|141596854|SUPERIORITY||Odds Ratio (OR)|2.8||||0.1|TWO_SIDED|95.0|0.8|9.6|||Regression, Logistic|||||9.6|0.8|0.100
71004125|NCT05171816|141516424|OTHER|Exploratory|Hazard Ratio (HR)|1.65||||0.4923|TWO_SIDED|95.0|0.61|4.87||Nominal p-value|Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by metastases.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||4.87|0.61|0.4923
71004126|NCT05171816|141516426|OTHER|Exploratory|Hazard Ratio (HR)|1.45||||0.3407|TWO_SIDED|95.0|0.63|3.39||Nominal p-value|Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by metastases.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||3.39|0.63|0.3407
71004127|NCT02000622|141516441|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.0009|TWO_SIDED|95.0|0.43|0.8||A priori threshold for statistical significance (2-sided) is 0.05.|Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|Study is sized to provide 90% power to detect a true treatment effect of PFS hazard ratio 0.653.||0.80|0.43|0.0009
71004128|NCT02000622|141516442|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.0033|TWO_SIDED|95.0|0.4|0.83||PFS2 tested using a multiple testing procedure with a recycling strategy. With 157 PFS2 events, a priori threshold for statistical significance (2-sided) was 0.008.|Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|||0.83|0.40|0.0033
71004129|NCT02000622|141516443|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.5665|TWO_SIDED|95.0|0.63|1.29||OS tested using a multiple testing procedure with a recycling strategy. With 140 OS events, a priori threshold for statistical significance (2-sided) was 0.018.|Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|||1.29|0.63|0.5665
71043727|NCT02776553|141596870|SUPERIORITY|||||||0.49|||||||ANCOVA|||||||0.49
71043728|NCT02776553|141596871|SUPERIORITY|||||||0.03|||||||ANCOVA|||||||0.03
71043729|NCT02776553|141596872|SUPERIORITY|||||||0.37|||||||ANCOVA|||||||0.37
71043730|NCT01043926|141596882|NON_INFERIORITY_OR_EQUIVALENCE|"AUC(0-∞) GMR = AUC(0-∞) GM for Moderate Hepatic Insufficiency Participants ÷ AUC(0-∞) GM for Healthy Participants~A 90% CI for the AUC(0-∞) GMR was computed from the ANCOVA model. As prespecified by the analysis plan, if the upper limit bound of the 90% CI for the AUC(0-∞) GMR fell below 2.00, then the hypothesis would be met and the AUC(0-∞) of suvorexant would be similar in both groups of participants. That is, if the true ratio of the GM AUC(0-∞) is no more than 2.00."|AUC(0-∞) Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|0.74|1.43|||ANCOVA|||"The geometric mean (GM) for each participant group and the corresponding 95% confidence interval (CI) were calculated for AUC(0-∞) using an analysis of covariance (ANCOVA) model.~The AUC(0-∞) geometric mean ratio (GMR) of the 2 participant groups was used to test the primary hypothesis, which was that the AUC(0-∞) of suvorexant following a single 20-mg oral dose would be similar between participants with moderate hepatic insufficiency and healthy matched control participants."||1.43|0.74|
71101238|NCT00581100|141710563|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
71043731|NCT01043926|141596883|NON_INFERIORITY_OR_EQUIVALENCE|"Cmax GMR = Cmax GM for Moderate Hepatic Insufficiency Participants ÷ Cmax GM for Healthy Participants~A 90% CI for the Cmax GMR was computed from the ANCOVA model. As prespecified by the analysis plan, if the upper limit bound of the 90% CI for the Cmax GMR fell below 2.00, then the hypothesis would be met and the Cmax of suvorexant would be similar in both groups of participants. That is, if the true ratio of the geometric mean Cmax is no more than 2.00."|Cmax Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.68|1.29|||ANCOVA|||"The GM for each participant group and the corresponding 95% CI were calculated for Cmax using an ANCOVA model.~The Cmax GMR of the 2 participant groups was used to test the primary hypothesis, which was that the Cmax of suvorexant following a single 20-mg oral dose would be similar between participants with moderate hepatic insufficiency and healthy matched control participants."||1.29|0.68|
71043732|NCT02598895|141596890|OTHER|||||||||||||||||The primary efficacy endpoint was percent patients achieving PSA decline of 50% or more from baseline (PSA50), assessed in the time prior to disease progression, unacceptable toxicity or 1 year after the last study medication. The historical comparison was PSA50 of 26%. The target response rate was 60%. The study followed an optimal two-stage Simon design (Simon, 1989) where the null hypothesis that the true PSA response rate PSA50 was 0.26 was tested against a one-sided alternative.|See above|||
71004130|NCT02000622|141516445|SUPERIORITY||Mean Difference (Final Values)|7.5||||0.0035|TWO_SIDED|95.0|2.5|12.4|||Mixed Models Analysis|Variables for treatment, visit, treatment-visit interaction, adjusted for baseline global health status/QoL score, baseline score-visit interaction.|Mean difference \>0 favours olaparib.|||12.4|2.5|0.0035
71043733|NCT00104247|141596891|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71043734|NCT01886937|141596892|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|||||||0.26
71043735|NCT00063882|141596893|SUPERIORITY||Cox Proportional Hazard|0.82||||0.21|TWO_SIDED|95.0|0.6|1.12||One-sided significance level of 0.025|Greenwood's T||Reference level = Brachytherapy only|Target sample size was 586; 532 patients were needed to test hypothesis of better FFP in the EBRT + Brachytherapy arm over the Brachytherapy Only arm. The trial is designed to detect a 10% improvement in 5-year FFP with 90% power, 1-sided alpha of 0.025. The Z-test statistic for the difference between the 2 5-year FFP rates with the standard errors estimated by Greenwood's method will be used.||1.12|0.60|0.21
71043736|NCT00063882|141596894|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.95|TWO_SIDED|95.0|0.63|1.54||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|||1.54|0.63|0.95
71004131|NCT02000622|141516446|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.0005|TWO_SIDED|95.0|0.41|0.78|||Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|||0.78|0.41|0.0005
71004132|NCT02000622|141516447|SUPERIORITY||Hazard Ratio (HR)|0.34|||<|0.0001|TWO_SIDED|95.0|0.24|0.47|||Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|Supportive analysis to PFS.||0.47|0.24|<0.0001
71004133|NCT02000622|141516448|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0002|TWO_SIDED|95.0|0.38|0.74|||Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|Supportive analysis to PFS2.||0.74|0.38|0.0002
71004134|NCT02000622|141516449|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.5131|TWO_SIDED|95.0|0.66|1.23||OS tested using a multiple testing procedure with a recycling strategy. With 192 OS events, a priori threshold for statistical significance was 0.045.|Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|||1.23|0.66|0.5131
71043737|NCT00063882|141596895|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.97|TWO_SIDED|95.0|0.64|1.58||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|||1.58|0.64|0.97
71043738|NCT00063882|141596896|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.77|TWO_SIDED|95.0|0.36|3.9||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|||3.90|0.36|0.77
71043739|NCT00063882|141596897|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.99|TWO_SIDED|95.0|0.33|3.13||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|||3.13|0.33|0.99
71004135|NCT02000622|141516450|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.4167|TWO_SIDED|95.0|0.67|1.18|||Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|||1.18|0.67|0.4167
71004136|NCT02000622|141516451|SUPERIORITY||Hazard Ratio (HR)|0.36|||<|0.0001|TWO_SIDED|95.0|0.27|0.5|||Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|Supportive analysis to PFS.||0.50|0.27|<0.0001
71004137|NCT02000622|141516452|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.4|0.72|||Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|Supportive analysis to PFS2.||0.72|0.40|<0.0001
71004138|NCT01405027|141516454|SUPERIORITY_OR_OTHER|||||||0.4864|TWO_SIDED||||||ANOVA|||||||0.4864
71043740|NCT00063882|141596898|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.81|TWO_SIDED|95.0|0.46|2.76||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|||2.76|0.46|0.81
71043741|NCT00063882|141596899|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.22|TWO_SIDED|95.0|0.51|1.17||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|||1.17|0.51|0.22
71043742|NCT00063882|141596900|SUPERIORITY||Odds Ratio (OR)|1.13||||0.53|TWO_SIDED|95.0|0.76|1.67||One-sided significance level of 0.05|Chi-squared||Reference level = Brachytherapy Only|Grade 2+ GU/GI||1.67|0.76|0.53
71043743|NCT00063882|141596900|SUPERIORITY||Odds Ratio (OR)|1.06||||0.73|TWO_SIDED|95.0|0.73|1.53||One-sided significance level of 0.05|Chi-squared||Reference level = Brachytherapy Only|Grade 2+ Overall||1.53|0.73|0.73
71043744|NCT00063882|141596900|SUPERIORITY||Odds Ratio (OR)|1.09||||0.81|TWO_SIDED|95.0|0.54|2.19||One-sided significance level of 0.05|Chi-squared||Reference level = Brachytherapy Only|Grade 3+ GU/GI||2.19|0.54|0.81
71043745|NCT00063882|141596900|SUPERIORITY||Odds Ratio (OR)|0.93||||0.82|TWO_SIDED|95.0|0.51|1.69||One-sided significance level of 0.05|Chi-squared||Reference level = Brachytherapy Only|Grade 3+ Overall||1.69|0.51|0.82
71043746|NCT00063882|141596901|SUPERIORITY||Hazard Ratio (HR)|2.37||||0.01|TWO_SIDED|95.0|1.2|4.68||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|Grade 3+ GU/GI||4.68|1.20|0.01
71004139|NCT05085327|141516459|OTHER|The t value from the '2-sided' Student-t distribution table corresponding to the upper 5% point with n-1 degrees of freedom was obtained and the labeled SPF value was determined as the largest whole number less than the following calculation: Labeled SPF = Mean SPF - (t\*SE).|CLM Original: Labeled SPF|13.0|||||TWO_SIDED|||||||||||||
71004140|NCT05085327|141516459|OTHER|The t value from the '2-sided' Student-t distribution table corresponding to the upper 5% point with n-1 degrees of freedom was obtained and the labeled SPF value was determined as the largest whole number less than the following calculation: Labeled SPF = Mean SPF - (t\*SE).|CLM Mint: Labeled SPF|13.0|||||TWO_SIDED|||||||||||||
71004141|NCT05085327|141516459|OTHER|The t value from the '2-sided' Student-t distribution table corresponding to the upper 5% point with n-1 degrees of freedom was obtained and the labeled SPF value was determined as the largest whole number less than the following calculation: Labeled SPF = Mean SPF - (t\*SE).|CLM Black Cherry: Labeled SPF|13.0|||||TWO_SIDED|||||||||||||
71004142|NCT03728881|141516462|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.5|||||TWO_SIDED|96.0|0.44|0.57|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.57|0.44|
71043747|NCT00063882|141596901|SUPERIORITY||Hazard Ratio (HR)|1.81||||0.029|TWO_SIDED|95.0|1.06|3.1||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|Grade 3+ Overall||3.10|1.06|0.029
71008629|NCT02055976|141525235|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.786|STANDARD_ERROR_OF_MEAN|1.918|<|0.001|TWO_SIDED|95.0|6.976|14.597|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||14.597|6.976|<0.001
71008630|NCT02055976|141525235|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.069|STANDARD_ERROR_OF_MEAN|1.945|<|0.001|TWO_SIDED|95.0|5.206|12.932|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||12.932|5.206|<0.001
71008631|NCT02055976|141525235|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.859|STANDARD_ERROR_OF_MEAN|2.173||0.014|TWO_SIDED|95.0|0.541|9.178|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.178|0.541|0.014
71008632|NCT02055976|141525235|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.331|STANDARD_ERROR_OF_MEAN|2.161|<|0.001|TWO_SIDED|95.0|3.037|11.624|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||11.624|3.037|<0.001
71008633|NCT02055976|141525235|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.075|STANDARD_ERROR_OF_MEAN|2.122|<|0.001|TWO_SIDED|95.0|4.856|13.293|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||13.293|4.856|<0.001
71008634|NCT02055976|141525235|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.936|STANDARD_ERROR_OF_MEAN|2.266||0.005|TWO_SIDED|95.0|1.435|10.437|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.437|1.435|0.005
71008635|NCT02055976|141525235|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.213|STANDARD_ERROR_OF_MEAN|2.271|<|0.001|TWO_SIDED|95.0|5.702|14.724|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||14.724|5.702|<0.001
71004143|NCT03728881|141516464|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|Ratio of the GMCs|1.11|||||TWO_SIDED|96.0|0.95|1.29|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.29|0.95|
71004144|NCT03728881|141516466|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.42|||||TWO_SIDED|99.0|0.36|0.5|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.50|0.36|
71004145|NCT03728881|141516468|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.9|||||TWO_SIDED|99.0|0.75|1.08|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|This procedure controls the overall type one error at 0.05. We are conducting 4 one sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.08|0.75|
71004146|NCT03728881|141516469|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|1|||||||Fisher Exact|||||||=1.0
71004147|NCT03728881|141516470|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|0.006|||||||Fisher Exact|||||||=0.006
71043748|NCT00063882|141596902|SUPERIORITY||Effect size|0.4|||<|0.0001|TWO_SIDED|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Urinary||||<0.0001
71004148|NCT03728881|141516471|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|1|||||||Fisher Exact|||||||=1.0
71004149|NCT03728881|141516472|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|0.48|||||||Fisher Exact|||||||=0.48
71043749|NCT00063882|141596902|SUPERIORITY||Effect size|0.09||||0.33|TWO_SIDED|||||significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Urinary- Incontinence||||0.33
71043750|NCT00063882|141596902|SUPERIORITY||Effect size|0.44|||<|0.0001|TWO_SIDED|||||significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Urinary-Irritative||||<0.0001
71043751|NCT00063882|141596902|SUPERIORITY||Effect size|0.31||||0.001|TWO_SIDED|||||significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Bowel||||0.001
71043752|NCT00063882|141596902|SUPERIORITY||Effect size|0.12||||0.23|TWO_SIDED||||||t-test, 2 sided|||Sexual|Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|||0.23
71043753|NCT00063882|141596903|SUPERIORITY||Effect size|0.38||||0.0002|TWO_SIDED|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Urinary||||0.0002
71043754|NCT00063882|141596903|SUPERIORITY||Effect size|0.08||||0.42|TWO_SIDED|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Urinary-Incontinence||||0.42
71101239|NCT00581100|141710563|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||\<Table 8-14\> Change from baseline in Physician and Patient Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS)|Mixed Models Analysis|||||||<0.0001
71101240|NCT00581100|141710564|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed-model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
71101241|NCT00581100|141710564|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed-model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
71004150|NCT03728881|141516478|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.49|||||TWO_SIDED|96.0|0.42|0.56|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||0.56|0.42|
71004151|NCT03728881|141516479|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.||||||1|||||||Fisher Exact|||||||1.0
71004152|NCT03728881|141516481|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|1.09|||||TWO_SIDED|96.0|0.93|1.27||||||||1.27|0.93|
71004153|NCT03728881|141516482|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|0.0006|||||||Fisher Exact|||||||=0.0006
71004154|NCT03728881|141516484|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.41|||||TWO_SIDED|99.0|0.35|0.49|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||0.49|0.35|
71004155|NCT03728881|141516485|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|1|||||||Fisher Exact|||||||=1.0
71004156|NCT03728881|141516487|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.86|||||TWO_SIDED|99.0|0.71|1.04|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||1.04|0.71|
71004157|NCT03728881|141516488|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|0.478|||||||Fisher Exact|||||||=0.478
71004158|NCT03728881|141516490|NON_INFERIORITY|We reject the noninferiority hypothesis if the lower limit of the two-sided 95% confidence interval on R ≥ 0.67 for HPV16 and HPV18.|GMC Ratio|1.33|||||TWO_SIDED|95.0|1.12|1.58|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||1.58|1.12|
71004159|NCT03728881|141516493|NON_INFERIORITY|We reject the noninferiority hypothesis if the lower limit of the two-sided 95% confidence interval on R ≥ 0.67 for HPV16 and HPV18.|GMC Ratio|1.29|||||TWO_SIDED|95.0|1.09|1.54|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||1.54|1.09|
71004160|NCT03728881|141516496|NON_INFERIORITY|We reject the noninferiority hypothesis if the lower limit of the two-sided 95% confidence interval on R ≥ 0.67 for HPV16 and HPV18.|GMC Ratio|1.48|||||TWO_SIDED|95.0|1.2|1.81|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||1.81|1.20|
71004161|NCT03728881|141516497|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose 9-10 year old girls and one-dose 11-14 year old girls. A p-value under 0.05 will be regarded as significant.|||||=|1|||||||Fisher Exact|||||||=1.0
71004162|NCT03728881|141516499|NON_INFERIORITY|We reject the noninferiority hypothesis if the lower limit of the two-sided 95% confidence interval on R ≥ 0.67 for HPV16 and HPV18.|GMC Ratio|1.42|||||TWO_SIDED|95.0|1.15|1.75|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||1.75|1.15|
71004163|NCT03728881|141516500|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose 9-10 year old girls and one-dose 11-14 year old girls. A p-value under 0.05 will be regarded as significant.|||||=|0.368|||||||Fisher Exact|||||||=0.368
71004164|NCT03728881|141516502|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.46|||||TWO_SIDED|96.0|0.38|0.56|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.56|0.38|
71004165|NCT03728881|141516502|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.58|||||TWO_SIDED|96.0|0.48|0.7|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||0.70|0.48|
71004166|NCT03728881|141516502|EQUIVALENCE|A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|||||=|0.079||||||The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|p-values test for heterogeneity|||||||=0.079
71004167|NCT03728881|141516503|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between the older one-dose recipients and the older three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|1|||||||Fisher Exact|||NOTE: Younger one-dose recipients (9-11 Year Old Girls) and three-dose recipients (18-21 Year Old Women) both had a 100% seroconversion proportion for HPV16 at 36 months, so a p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate between older one-dose recipients (9-11 Year Old Girls) and three-dose recipients (22-25 Year Old Women).||||=1.0000
71004168|NCT03728881|141516505|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|1.01|||||TWO_SIDED|96.0|0.82|1.25||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.25|0.82|
71004169|NCT03728881|141516505|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|1.24|||||TWO_SIDED|96.0|1.01|1.54||||||The cohort for the analysis of HPV16 at 36 months by enrollment age group includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 36-month mark, and reported no additional HPV vaccinations outside the study before the 36-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11.||1.54|1.01|
71004170|NCT03728881|141516505|EQUIVALENCE|A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|||||=|0.14||||||The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|p-values test for heterogeneity|||||||=0.14
71004171|NCT03728881|141516506|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between the younger one-dose recipients and the younger three-dose recipients.|||||=|0.001||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||Calculated p-value for the comparison of the seroconversion rate for HPV18 at 36 months between younger one-dose recipients (9-11 Year Old Girls) and the younger three-dose recipients (18-21 Year Old Women).||||=0.001
71004172|NCT03728881|141516506|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between older one-dose and older three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|0.737||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||Calculated p-value for the comparison of the seroconversion rate for HPV18 at 36 months between older one-dose recipients (12-14 Year Old Girls) and the older three-dose recipients (22-25 Year Old Women).||||=0.737
71004173|NCT03728881|141516508|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.41|||||TWO_SIDED|99.0|0.33|0.52||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.52|0.33|
71004174|NCT03728881|141516508|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.47|||||TWO_SIDED|99.0|0.37|0.6||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.60|0.37|
71043755|NCT00063882|141596903|SUPERIORITY||Effect size|0.44|||<|0.0001|TWO_SIDED|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Urinary-Irritative||||<0.0001
71043756|NCT00063882|141596903|SUPERIORITY||Effect size|0.42|||<|0.0001|TWO_SIDED|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Bowel||||<0.0001
71043757|NCT00063882|141596903|SUPERIORITY||Effect size|0.27||||0.0072|TWO_SIDED|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Sexual||||0.0072
71043758|NCT03314662|141596922|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% confidence interval (CI) for the ratios of GMTs (aTIV/aQIV) do not exceed 1.5|GMT ratio (aTIV/aQIV)|1.16|||||TWO_SIDED|95.0|1.05|1.27|||||GMT ratios (adjusted) obtained from a GLM fitted on log-transformed (base 10) post-vaccination HI titer as outcome variable and covariate terms: treatment, pre-vaccination HI titer (log10 transformed), age, sex, vaccination history, study site|Comparison Group Selection: aTIV/aQIV - for strain A/H1N1||1.27|1.05|
71043759|NCT03314662|141596922|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% confidence interval (CI) for the ratios of GMTs (aTIV/aQIV) do not exceed 1.5|GMT ratio: (aTIV/aQIV|0.99|||||TWO_SIDED|95.0|0.9|1.09|||||GMT ratios (adjusted) obtained from a GLM fitted on log-transformed (base 10) post-vaccination HI titer as outcome variable and covariate terms: treatment, pre-vaccination HI titer (log 10 transformed), age, sex, vaccination history, study site|Comparison Group Selection: aTIV/aQIV - performed for strain A/H3N2||1.09|0.90|
71043760|NCT03314662|141596922|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% confidence interval (CI) for the ratios of GMTs (aTIV/aQIV) do not exceed 1.5.|GMT ratio: aTIV/aQIV|0.99|||||TWO_SIDED|95.0|0.9|1.08|||||GMT ratios (adjusted) obtained from a GLM fitted on log-transformed (base 10) post-vaccination HI titer as outcome variable and covariate terms: treatment, pre-vaccination HI titer (log10 transformed), age, sex, vaccination history, study site|Comparison Group Selection: aQIV/aTIV - performed for strain B/Yamagata||1.08|0.90|
71043761|NCT03314662|141596922|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% confidence interval (CI) for the ratios of GMTs (aTIV/aQIV) do not exceed 1.5.|GMT ratio: (aTIV/aQIV)]|0.98|||||TWO_SIDED|95.0|0.89|1.08|||||GMT ratios (adjusted) obtained from a GLM fitted on log-transformed (base 10) post-vaccination HI titer as outcome variable and covariate terms: treatment, pre-vaccination HI titer (log10 transformed), age, sex, vaccination history, study site|Comparison Group Selection: aQIV/aTIV - performed for strain B/Victoria||1.08|0.89|
71043762|NCT03314662|141596923|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% CI for the differences between the SCRs (aTIV - aQIV) do not exceed 10% for each of the four strains|SCR difference (aTIV minus aQIV)|3.23|||||TWO_SIDED|95.0|-1.3|7.76||||||Comparison Group Selection: aTIV minus aQIV - for strain A/H1N1||7.76|-1.30|
71043763|NCT03314662|141596923|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% CI for the differences between the SCRs (aTIV - aQIV) do not exceed 10% for each of the four strains|SCR difference (aTIV minus aQIV)|0.37|||||TWO_SIDED|95.0|-4.23|4.96||||||Comparison Group Selection: aTIV minus aQIV - for strain A/H3N2||4.96|-4.23|
71101242|NCT05170061|141710584|SUPERIORITY|||||||0.05||||||see above|t-test, 2 sided|paired analysis||Sequential analysis: if the first analysis (paired t-test to determine superiority of nebivolol/valsartan over valsartan ) reached p\< 0.05, the superiority of nebivolol over valsartan was tested (paired-t test); if the second comparison reached p \< 0.05, the superiority of nebivolol/valsartan over nebivolol was tested (paired-t test)||||0.05
71043764|NCT03314662|141596923|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% CI for the differences between the SCRs (aTIV - aQIV) do not exceed 10% for each of the four strains|SCR difference (aTIV minus aQIV)]|-0.93|||||TWO_SIDED|95.0|-5.13|3.27||||||Comparison Group Selection: aTIV minus aQIV - for strain B-Yamagata||3.27|-5.13|
71043765|NCT03314662|141596923|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% CI for the differences between the SCRs (aTIV - aQIV) do not exceed 10% for each of the four strains|Other [SCR difference (aTIV minus aQIV)]|-1.26|||||TWO_SIDED|95.0|-5.07|2.55||||||Comparison Group Selection: aTIV minus aQIV - for strain B-Victoria||2.55|-5.07|
71043766|NCT03314662|141596926|SUPERIORITY|Superiority of aQIV vs. aTIV-1 for the alternate B strain was assessed using the GMT ratio (GMTaTIV/GMTaQIV); Superiority was declared if the upper limit of the two-sided 95% CI for the GMT ratio (aTIV/aQIV) was \<1. The superiority comparison was based on the Full Analysis Set (FAS) Immunogenicity comprised all subjects who were randomized, received at least 1 study vaccination, and provided immunogenicity data at Day 1 and Day 22.|GMT ratio|0.64|||||TWO_SIDED|95.0|0.58|0.7||||||B/Yamagata strain: GMT Ratio (aTIV/aQIV)||0.70|0.58|
71043767|NCT03314662|141596926|SUPERIORITY|Superiority of aQIV vs. aTIV-2 for the alternate B strain was assessed using the GMT ratio (GMTaTIV/GMTaQIV); Superiority was declared if the upper limit of the two-sided 95% CI for the GMT ratio (aTIV/aQIV) was \<1. The superiority comparison was based on the FAS Immunogenicity.|GMT ratio|0.71|||||TWO_SIDED|95.0|0.64|0.78||||||B/Victoria Strain: GMT Ratio (aTIV/aQIV)||0.78|0.64|
71043768|NCT03314662|141596929|SUPERIORITY|Superiority of aQIV vs. aTIV-1 for the alternate B strain was assessed using the difference in SCR (SCRaTIV-SCRaQIV) at Day 22. Superiority was declared if the upper limit of the two-sided 95% CI for the difference in SCRs (aTIV-aQIV) was \<0, for both B strains. The superiority comparison was based on the FAS Immunogenicity.|SCR difference|-11.96|||||TWO_SIDED|95.0|-15.12|-8.81||||||B/Yamagata Strain: SCR Difference (aTIV-1 - aQIV).||-8.81|-15.12|
71043769|NCT03314662|141596929|SUPERIORITY|Superiority of aQIV vs. aTIV-2 for the alternate B strain was assessed using the difference in SCR (SCRaTIV-SCRaQIV) at Day 22. Superiority was declared if the upper limit of the two-sided 95% CI for the difference in SCRs (aTIV-aQIV) was \<0, for both B strains. The superiority comparison was based on the FAS Immunogenicity.|SCR difference|-10.82|||||TWO_SIDED|95.0|-13.54|-8.11||||||B/Victoria Strain: SCR Difference (aTIV-2 - aQIV)||-8.11|-13.54|
71101243|NCT05170061|141710585|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||||||0.05
71101244|NCT05170061|141710586|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71101245|NCT05170061|141710587|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71101246|NCT05170061|141710588|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71101247|NCT05170061|141710589|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71101248|NCT05170061|141710590|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71004175|NCT03728881|141516508|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.028||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.028
71004176|NCT03728881|141516509|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between the older one-dose recipients and the older three-dose recipients.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||NOTE: Younger one-dose recipients (9-11 Year Old Girls) and three-dose recipients (18-21 Year Old Women) both had a 100% seroconversion proportion for HPV16 at 24months, so a p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate between older one-dose recipients (9-11 Year Old Girls) and three-dose recipients (22-25 Year Old Women).||||=1.000
71004177|NCT03728881|141516511|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.85|||||TWO_SIDED|99.0|0.65|1.1||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.10|0.65|
71004178|NCT03728881|141516511|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|1.0|||||TWO_SIDED|99.0|0.77|1.29||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.29|0.77|
71004179|NCT03728881|141516511|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.24||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|The p-values test for heterogeneity|||||||=0.24
71004180|NCT03728881|141516512|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between younger one-dose and younger three-dose recipients.|||||=|0.216||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate of HPV18 at 24 months between younger one-dose recipients (9-12 Year Old Girls) and younger three-dose recipients (18-21 Year Old Women).||||=0.216
71004181|NCT03728881|141516512|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between older one-dose and older three-dose recipients.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate of HPV18 at 24 months between older one-dose recipients (12-14 Year Old Girls) and older three-dose recipients (22-25 Year Old Women).||||=1.000
71004182|NCT03728881|141516514|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.52|||||TWO_SIDED|96.0|0.43|0.64||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.64|0.43|
71004183|NCT03728881|141516514|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.49|||||TWO_SIDED|96.0|0.41|0.58||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.58|0.41|
71004184|NCT03728881|141516514|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.73||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|The p-values test for heterogeneity|||||||=0.73
71004185|NCT03728881|141516515|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate one-dose and three-dose recipients who enrolled June - August.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||NOTE: One-dose recipients and three-dose recipients enrolled April - May both had a 100% seroconversion proportion for HPV16 at 36 months, so the p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate between one-dose recipients and three-dose recipients enrolled June - August.||||=1.000
71008636|NCT02055976|141525235|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.056|STANDARD_ERROR_OF_MEAN|2.302|<|0.001|TWO_SIDED|95.0|3.484|12.629|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||12.629|3.484|<0.001
71004186|NCT03728881|141516517|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|1.26||||||96.0|1.0|1.58||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.58|1.00|
71004187|NCT03728881|141516517|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|1.01||||||96.0|0.83|1.24||||||||1.24|0.83|
71004188|NCT03728881|141516517|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.15||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|The p-values test for heterogeneity|||||||=0.15
71004189|NCT03728881|141516518|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled April - May.|||||=|0.253||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate of HPV18 at 36 months between one-dose recipients and three-dose recipients enrolled April - May.||||=0.253
71004190|NCT03728881|141516518|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled June - August.|||||=|0.015||||||A p-value under 0.05 will be regarded as significant|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate of HPV18 at 36 months between one-dose recipients and three-dose recipients enrolled June - August.||||=0.015
71004191|NCT03728881|141516520|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.43||||||99.0|0.33|0.55||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.55|0.33|
71004192|NCT03728881|141516520|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.42|||||TWO_SIDED|99.0|0.34|0.52||||||||0.52|0.34|
71004193|NCT03728881|141516520|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.95||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.95
71004194|NCT03728881|141516521|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled June - August.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||NOTE: One-dose recipients and three-dose recipients enrolled April - May both had a 100% seroconversion proportion for HPV16 at 24 months, so the p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate between one-dose recipients and three-dose recipients enrolled June - August.||||=1.000
71004195|NCT03728881|141516523|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.91|||||TWO_SIDED|99.0|0.69|1.19||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.19|0.69|
71004196|NCT03728881|141516523|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.89|||||TWO_SIDED|99.0|0.69|1.14||||||||1.14|0.69|
71004197|NCT03728881|141516523|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.88||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.88
71004198|NCT03728881|141516524|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled April - May.|||||=|0.629||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate of HPV18 at 24 months between one-dose recipients and three-dose recipients enrolled April - May.||||=0.629
71043770|NCT01117766|141596935|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.537||0.7319|TWO_SIDED|95.0|-1.29|0.92|||ANCOVA|||Week 3 (Visits 3 and 6)||0.92|-1.29|0.7319
71101249|NCT05170061|141710591|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71004199|NCT03728881|141516524|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled June - August.|||||=|0.175||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate of HPV18 at 24 months between one-dose recipients and three-dose recipients enrolled June - August.||||=0.175
71008637|NCT02055976|141525235|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.846|STANDARD_ERROR_OF_MEAN|1.778|<|0.001|TWO_SIDED|95.0|2.312|9.38|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.380|2.312|<0.001
71101250|NCT05170061|141710592|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71101251|NCT05170061|141710593|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71101252|NCT05170061|141710594|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71101253|NCT05170061|141710595|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71101254|NCT05170061|141710596|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71101255|NCT05170061|141710597|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71101256|NCT05170061|141710598|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71101257|NCT05170061|141710599|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71101258|NCT05170061|141710600|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71101259|NCT05170061|141710601|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71101260|NCT05170061|141710602|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71101261|NCT05170061|141710603|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71101262|NCT05170061|141710604|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71101263|NCT05170061|141710605|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71101264|NCT02579759|141710622|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.14||0.008|TWO_SIDED|97.5|-0.68|-0.06|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||-0.06|-0.68|0.008
71101265|NCT02579759|141710622|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.12||0.287|TWO_SIDED|97.5|-0.39|0.14|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.14|-0.39|0.287
71101266|NCT02579759|141710622|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.13||0.013|TWO_SIDED|97.5|-0.59|-0.03|||Longitudinal mixed model|||"This analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: Longitudinal model where the effect of each treatment over time (baseline, 6, 12 and 15 months) was estimated through a mixed model with repeated measures (MMRM) assuming time from baseline (Time) and Time-by-Treatment full interaction as fixed effects and patient as random effect and considering Time as continuous linear effect~3. Missing value imputation: No imputation"||-0.03|-0.59|0.013
71008638|NCT02055976|141525235|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.91|STANDARD_ERROR_OF_MEAN|1.766|<|0.001|TWO_SIDED|95.0|3.4|10.421|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.421|3.400|<0.001
71008639|NCT02055976|141525235|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.168|STANDARD_ERROR_OF_MEAN|1.748||0.01|TWO_SIDED|95.0|0.693|7.642|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.642|0.693|0.010
71008640|NCT02055976|141525237|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.7208|STANDARD_ERROR_OF_MEAN|0.6289||0.127|TWO_SIDED|95.0|-0.5283|1.97|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.9700|-0.5283|0.127
71008641|NCT02055976|141525237|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.0574|STANDARD_ERROR_OF_MEAN|0.6461||0.053|TWO_SIDED|95.0|-0.2259|2.3406|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||2.3406|-0.2259|0.053
71004200|NCT03728881|141516526|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.52||||||96.0|0.43|0.64||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.64|0.43|
71043771|NCT01117766|141596935|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.536||0.3404|TWO_SIDED|95.0|-1.61|0.57|||ANCOVA|||Week 4 (Visits 4 and 7)||0.57|-1.61|0.3404
71043772|NCT01117766|141596936|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.32|STANDARD_ERROR_OF_MEAN|26.872||0.6539|TWO_SIDED|95.0|-70.2|45.56|||ANCOVA|||Week 3 (Visits 3 and 6)||45.56|-70.20|0.6539
71043773|NCT01117766|141596936|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.91|STANDARD_ERROR_OF_MEAN|25.807||0.3678|TWO_SIDED|95.0|-78.54|30.72|||ANCOVA|||Week 4 (Visits 4 and 7)||30.72|-78.54|0.3678
71043774|NCT01117766|141596937|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09|STANDARD_ERROR_OF_MEAN|0.342||0.0071|TWO_SIDED|95.0|-1.84|-0.35|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 3 (Visits 3 and 6)||-0.35|-1.84|0.0071
71043775|NCT01117766|141596937|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59|STANDARD_ERROR_OF_MEAN|0.37||0.1294|TWO_SIDED|95.0|-1.36|0.19|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 4 (Visits 4 and 7)||0.19|-1.36|0.1294
71043776|NCT01117766|141596938|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-61.54|STANDARD_ERROR_OF_MEAN|25.298||0.03|TWO_SIDED|95.0|-116.12|-6.96|||ANCOVA|||Week 3 (Visits 3 and 6)||-6.96|-116.12|0.0300
71043777|NCT01117766|141596938|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-49.06|STANDARD_ERROR_OF_MEAN|26.501||0.0844|TWO_SIDED|95.0|-105.67|7.55|||ANCOVA|||Week 4 (Visits 4 and 7)||7.55|-105.67|0.0844
71043778|NCT01117766|141596939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.478||0.7506|TWO_SIDED|95.0|-0.83|1.14|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 3 (Visits 3 and 6)||1.14|-0.83|0.7506
71043779|NCT01117766|141596939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.299||0.9673|TWO_SIDED|95.0|-0.61|0.64|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 4 (Visits 4 and 7)||0.64|-0.61|0.9673
71043780|NCT01117766|141596940|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39|STANDARD_ERROR_OF_MEAN|0.642||0.5502|TWO_SIDED|95.0|-0.99|1.78|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 3 (Visits 3 and 6)||1.78|-0.99|0.5502
71043781|NCT01117766|141596940|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.5||0.8536|TWO_SIDED|95.0|-1.15|0.96|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 4 (Visits 4 and 7)||0.96|-1.15|0.8536
71043782|NCT01117766|141596941|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.54|STANDARD_ERROR_OF_MEAN|0.586||0.0132|TWO_SIDED|95.0|-2.73|-0.34|||ANCOVA||In statistical analyses, scores were further grouped to 1-3 'improved', 4 'no change' and 5-7 'worsened'.|Week 3 (Visits 3 and 6)||-0.34|-2.73|0.0132
71043783|NCT01117766|141596941|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|0.467||0.0403|TWO_SIDED|95.0|-1.95|-0.05|||ANCOVA||In statistical analyses, scores were further grouped to 1-3 'improved', 4 'no change' and 5-7 'worsened'.|Week 4 (Visits 4 and 7)||-0.05|-1.95|0.0403
71043784|NCT01117766|141596942|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.433||0.6631|TWO_SIDED|95.0|-1.12|0.74|||ANCOVA|||Week 3 (Visits 3 and 6)||0.74|-1.12|0.6631
71043785|NCT01117766|141596942|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.54|STANDARD_ERROR_OF_MEAN|0.465||0.0022|TWO_SIDED|95.0|-2.48|-0.59|||ANCOVA|||Week 4 (Visits 4 and 7)||-0.59|-2.48|0.0022
71043786|NCT01117766|141596943|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.04|STANDARD_ERROR_OF_MEAN|0.722||0.1753|TWO_SIDED|95.0|-2.6|0.53|||ANCOVA|||Week 3 (Visits 3 and 6)||0.53|-2.60|0.1753
71043787|NCT01117766|141596943|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.51|STANDARD_ERROR_OF_MEAN|0.588||0.0198|TWO_SIDED|95.0|-2.75|-0.27|||ANCOVA|||Week 4 (Visits 4 and 7)||-0.27|-2.75|0.0198
71043788|NCT01117766|141596944|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.29|STANDARD_ERROR_OF_MEAN|6.292||0.4999|TWO_SIDED|95.0|-17.13|8.54|||ANCOVA|||||8.54|-17.13|0.4999
71043789|NCT00438659|141596945|SUPERIORITY_OR_OTHER|||||||0.18|||||||t-test, 2 sided|||||||0.18
71043790|NCT03407612|141596979|EQUIVALENCE|p \< 0.05 required for groups to have non-equivalent results.||||||0.67|||||||t-test, 2 sided|||This analysis considers the baseline HOS-ADL measures.||||0.67
71043791|NCT03407612|141596979|EQUIVALENCE|p \< 0.05 required for groups to have non-equivalent results.||||||0.73|||||||t-test, 2 sided|||This analysis considers the 6 week postoperative HOS-ADL measures.||||0.73
71043792|NCT03407612|141596979|EQUIVALENCE|p \< 0.05 required for groups to have non-equivalent results.||||||0.87|||||||t-test, 2 sided|||This analysis considers the 12 week postoperative HOS-ADL measures.||||0.87
71043793|NCT03407612|141596979|EQUIVALENCE|p \< 0.05 required for groups to have non-equivalent results.||||||0.78|||||||t-test, 2 sided|||This analysis considers the 6 month postoperative HOS-ADL measures.||||0.78
71043794|NCT03407612|141596980|EQUIVALENCE|p \< 0.05 required for groups to have non-equivalent results.||||||0.25|||||||t-test, 2 sided|||||||0.25
71043795|NCT03407612|141596981|EQUIVALENCE|p \< 0.05 required for groups to have non-equivalent results.||||||0.04|||||||t-test, 2 sided|||||||0.04
71043796|NCT03919448|141597044|EQUIVALENCE|The comparable bioavailability was achieved if 90 % confidence intervals (CIs) for the test-to-reference ratios of the geometric means of Cmax, Area Under the Serum Concentration-time Curve of Bevacizumab (ABC0-t) fell within the 80.00-125.00 % acceptance criteria.|Hazard Ratio (HR)|101.55||||0.9766|TWO_SIDED|90.0|90.19|114.34||Power of ANOVA: 0,93|ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||114.34|90.19|0.9766
71004201|NCT03728881|141516526|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.48||||||96.0|0.4|0.58||||||||0.58|0.40|
71004202|NCT03728881|141516526|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.46||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.46
71004203|NCT03728881|141516527|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients from coastal districts.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||NOTE: One-dose recipients and three-dose recipients enrolled from mountainous districts both had a 100% seroconversion proportion for HPV16 at 36 months, so the p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate for HPV16 at 36 months between one-dose recipients and three-dose recipients enrolled from coastal districts.||||=1.000
71004204|NCT03728881|141516529|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|1.27||||||96.0|1.03|1.57||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.57|1.03|
71004205|NCT03728881|141516529|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.99||||||96.0|0.8|1.23||||||||1.23|0.80|
71004206|NCT03728881|141516529|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.095||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.095
71004207|NCT03728881|141516530|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled from coastal districts.|||||=|0.327||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate for HPV18 at 36 months between one-dose recipients and three-dose recipients enrolled from coastal districts.||||=0.327
71004208|NCT03728881|141516530|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled from mountainous districts.|||||=|0.012||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate for HPV18 at 36 months between one-dose recipients and three-dose recipients enrolled from mountainous districts.||||=0.012
71004209|NCT03728881|141516532|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.45|||||TWO_SIDED|99.0|0.36|0.58||||||||0.58|0.36|
71043797|NCT03919448|141597044|EQUIVALENCE|The comparable bioavailability was achieved if 90 % confidence intervals (CIs) for the test-to-reference ratios of the geometric means of Cmax, Area Under the Serum Concentration-time Curve of Bevacizumab (ABC0-t) fell within the 80.00-125.00 % acceptance criteria.|Hazard Ratio (HR)|100.95||||0.9766|TWO_SIDED|90.0|89.75|113.55||Power of ANOVA: 0,93|ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||113.55|89.75|0.9766
71043798|NCT03919448|141597044|EQUIVALENCE|As supplementary information, Test Product 1 vs. Test Product 2 shall also be compared. The comparable bioavailability was achieved if 90 % confidence intervals (CIs) for the test1-to-test2 ratios of the geometric means of Cmax, Area Under the Serum Concentration-time Curve of Bevacizumab (ABC0-t) fell within the 80.00-125.00 % acceptance criteria.|Hazard Ratio (HR)|100.59||||0.9766|TWO_SIDED|90.0|88.16|114.77|||ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||114.77|88.16|0.9766
71101267|NCT02579759|141710622|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.05|TWO_SIDED|97.5|-0.42|0.03|||Longitudinal mixed model|||"This analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: Longitudinal model where the effect of each treatment over time (baseline, 6, 12 and 15 months) was estimated through a mixed model with repeated measures (MMRM) assuming time from baseline (Time) and Time-by-Treatment full interaction as fixed effects and patient as random effect and considering Time as continuous linear effect~3. Missing value imputation: No imputation"||0.03|-0.42|0.05
71004210|NCT03728881|141516532|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.4|||||TWO_SIDED|99.0|0.32|0.5||||||||0.50|0.32|
71004211|NCT03728881|141516532|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.3||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.30
71004212|NCT03728881|141516533|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled from coastal districts.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||NOTE: One-dose recipients and three-dose recipients enrolled from mountainous districts had a 100% seroconversion proportion for HPV16 at 24 months, so the p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate for HPV16 at 24 months between one-dose recipients and three-dose recipients enrolled from coastal districts.||||=1.000
71004213|NCT03728881|141516535|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|1.02||||||99.0|0.79|1.32||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.32|0.79|
71004214|NCT03728881|141516535|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.81||||||99.0|0.63|1.04||||||||1.04|0.63|
71004215|NCT03728881|141516535|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.1||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.10
71004216|NCT03728881|141516536|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled from coastal districts.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate for HPV18 at 24 months between one-dose recipients and three-dose recipients enrolled from coastal districts.||||=1.000
71004217|NCT03728881|141516536|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled from mountainous districts.|||||=|0.339||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate for HPV18 at 24 months between one-dose recipients and three-dose recipients enrolled from mountainous districts.||||=0.339
71004218|NCT04088331|141516558|SUPERIORITY||||||<|0.001|||||||Exact binomial test|||"Hypotheses:~H0: p ≤ 0.65 H1: p \> 0.65 where p = the proportion of subjects who are a treatment success.~Hypotheses evaluated using a one-sided exact binomial test.~Power calculation assumed a treatment success rate of 80%. With a one-sided type I error of 0.025 and a type II error of 0.10 (90% power), a sample size of 96 subjects needed to demonstrate the proportion of subjects who are a treatment success exceeds 65%."||||< 0.001
71004219|NCT01994109|141516568|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71004220|NCT01994109|141516568|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70924683|NCT04321031|141342044|SUPERIORITY||Risk Difference (RD)|0.27|||||TWO_SIDED|90.0|0.06|0.53||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.53|0.06|
71004221|NCT01994109|141516569|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71004222|NCT01994109|141516569|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71004223|NCT00576147|141516570|SUPERIORITY_OR_OTHER||Percent Sensitivity|88.0|||||TWO_SIDED|95.0|75.0|95.0||||||||95.0|75.0|
71004224|NCT00576147|141516570|SUPERIORITY_OR_OTHER||Percent Specificity|90.7|||||TWO_SIDED|95.0|86.4|93.7||||||||93.7|86.4|
71004225|NCT01933399|141516580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.4||||0.01|TWO_SIDED|95.0|2.2|16.6|||ANCOVA||"Difference in mean change in scores from baseline to follow-up by treatment group with no adjusment for baseline.~a priori threshold determined to be .05. no adjustments for multiple comparisons."|ANCOVA Adjusted for baseline score||16.6|2.2|.01
71004226|NCT01933399|141516580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3||||0.16|TWO_SIDED|95.0|-2.0|12.6||a priori threshold determined to be .05. no adjustments for multiple comparisons.|ANCOVA|Adjustment for baseline.||||12.6|-2.0|.16
71004227|NCT01933399|141516581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.01|TWO_SIDED|95.0|-2.3|-0.4|||ANCOVA|||Adjusted for baseline.||-0.4|-2.3|0.01
71004228|NCT01933399|141516581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.05|TWO_SIDED|95.0|-2.1|0.0|||ANCOVA|||Adjusted for baseline.||0|-2.1|.05
71008642|NCT02055976|141525237|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.2445|STANDARD_ERROR_OF_MEAN|0.6511||0.354|TWO_SIDED|95.0|-1.0486|1.5375|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.5375|-1.0486|0.354
71043799|NCT03919448|141597045|EQUIVALENCE|The comparable bioavailability was achieved if 90% confidence intervals (CIs) for the test to reference ratios of the geometric means of Cmax, Area under the serum concentration-time curve of bevacizumab (ABC0-t) fell within the 80.00-125.00% acceptance criteria.|Hazard Ratio (HR)|90.82||||0.3617|TWO_SIDED|90.0|81.21|101.57||Power of ANOVA: 0,95|ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||101.57|81.21|0.3617
71043800|NCT03919448|141597045|EQUIVALENCE|The comparable bioavailability was achieved if 90% confidence intervals (CIs) for the test to reference ratios of the geometric means of Cmax, Area under the serum concentration-time curve of bevacizumab (ABC0-t) fell within the 80.00-125.00% acceptance criteria.|Hazard Ratio (HR)|94.87||||0.3617|TWO_SIDED|90.0|84.91|105.99||Power of ANOVA: 0.95|ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||105.99|84.91|0.3617
71043801|NCT03919448|141597045|EQUIVALENCE|As supplementary information, Test Product 1 vs. Test Product 2 shall also be compared. The comparable bioavailability was achieved if 90 % confidence intervals (CIs) for the test1-to-test2 ratios of the geometric means of Cmax, Area under the serum concentration-time curve of bevacizumab (ABC0-t) fell within the 80.00-125.00 % acceptance criteria.|Hazard Ratio (HR)|95.73||||0.3617|TWO_SIDED|90.0|84.82|108.05|||ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||108.05|84.82|0.3617
71043802|NCT03919448|141597046|EQUIVALENCE|80.00-125.00% acceptance criteria.|Hazard Ratio (HR)|90.46||||0.3529|TWO_SIDED|90.0|80.64|101.47||Power of ANOVA: 0.94|ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||101.47|80.64|0.3529
71043803|NCT03919448|141597046|EQUIVALENCE|80.00-125.00% acceptance criteria.|Hazard Ratio (HR)|95.02||||0.3529|TWO_SIDED|90.0|84.8|106.49||Power of ANOVA: 0.94|ANOVA|||||106.49|84.80|0.3529
71043804|NCT03919448|141597046|EQUIVALENCE|As supplementary information, Test Product 1 vs. Test Product 2 shall also be compared. The comparable bioavailability was achieved if 90 % confidence intervals (CIs) for the test1-to-test2 ratios of the geometric means of Cmax, Area under the serum concentration-time curve of bevacizumab (ABC0-t) fell within the 80.00-125.00 % acceptance criteria.|Hazard Ratio (HR)|95.19||||0.3529|TWO_SIDED|90.0|84.17|107.67|||ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||107.67|84.17|0.3529
71043805|NCT01002794|141597069|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||Power calculation: The sample size calculation was based on the change in KOOS4 from baseline to two year follow-up. To detect a 10 point difference with a standard deviation of 15, with a level of power of 90%, level of significance of 0.05, and an estimated 15% dropout rate at two years, we determined that we would need 56 participants in each group. To allow for a 20% crossover rate, we randomised 140 participants.||||<0.05
71043806|NCT01005329|141597105|OTHER||||||||||||||||||The rate of the acute specified AEs (adverse events) from previous (and prior to ClinicalTrials.gov requirements) Radiation Therapy Oncology Group (RTOG) trial 9708 of RT + cisplatin was 44% and the hypothesis is that the addition of bevacizumab to IMRT + cisplatin will not increase this rate beyond 60%. This study was designed with a 1-sided, upper bound confidence interval to estimate this AE rate. Twenty-seven evaluable patients were required to have 95% confidence that the true grade 3+ non-hematologic treatment-related AE rate is not greater than 60%. Please note that this is a 95% ONE-SIDED confidence bound which is equivalent to the upper bound of a two-sided 90% confidence interval.|||
71043807|NCT02997657|141597112|SUPERIORITY|||||||0.71|||||||Chi-squared|||||||0.71
71043808|NCT02997657|141597113|SUPERIORITY|||||||0.81|||||||Chi-squared|||||||0.81
71043809|NCT02997657|141597114|SUPERIORITY|||||||0.69|||||||Chi-squared|||||||0.69
71043810|NCT02997657|141597115|SUPERIORITY|||||||0.96|||||||Chi-squared|||||||0.96
71101268|NCT02579759|141710622|SUPERIORITY||Slope|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.013|TWO_SIDED|95.0|-0.31|-0.04|||Regression, Linear|||"Dose effect:~Dose is defined as a numerical variable proportional to quantity of PXT3003 administered (0 for Placebo, 1 for Dose 1, 2 for Dose 2).~The analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA assessing the dose-effect at the mean of 12 and 15 months, adjusting for baseline value and assuming centre as random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||-0.04|-0.31|0.013
71101269|NCT02579759|141710623|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.19||0.016|TWO_SIDED|97.5|-0.91|-0.03|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||-0.03|-0.91|0.016
71043811|NCT02997657|141597116|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
71043812|NCT02997657|141597117|SUPERIORITY|||||||0.9|||||||Chi-squared|||||||0.90
71043813|NCT02997657|141597118|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||||||0.82
71043814|NCT01272921|141597119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52|||<|0.001|TWO_SIDED|95.0|0.49|0.54|||Z score|||||0.54|0.49|<0.001
71043815|NCT01272921|141597119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|||<|0.001|TWO_SIDED|95.0|0.18|0.21|||Z score|||||0.21|0.18|<0.001
71043816|NCT01272921|141597120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0|STANDARD_DEVIATION|0.0||0.05|TWO_SIDED|95.0|-17.0|-6.0||Post hoc comparison were made against the 30-mL volume group and corrected for 6 comparisons using the Wilcoxon rank sum test.|Wilcoxon (Mann-Whitney)|||The sample selected for this study,70 per drug group (or 10 in each of the 7 groups), achieves 88% power to detect a minimal difference of 4 hours in duration at a significance level (α) of 0.05 and a standard deviation of 3 hours using Williams test. We chose a difference of 4 hours as this was the interval used for assessment in the postoperative period at night. We sought to detect a difference that was equal to 1 observation period difference.||-6.00|-17.00|0.05
71043817|NCT01272921|141597120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0|STANDARD_DEVIATION|0.0||0.05|TWO_SIDED|95.0|-15.0|-6.0|||Wilcoxon (Mann-Whitney)|||The sample selected for this study,70 per drug group (or 10 in each of the 7 groups), achieves 88% power to detect a minimal difference of 4 hours in duration at a significance level (α) of 0.05 and a standard deviation of 3 hours using Williams test. We chose a difference of 4 hours as this was the interval used for assessment in the postoperative period at night. We sought to detect a difference that was equal to 1 observation period difference.||-6.00|-15.00|0.05
71043818|NCT01272921|141597120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.0|STANDARD_DEVIATION|0.0||0.05|TWO_SIDED|95.0|-10.0|-4.0|||Wilcoxon (Mann-Whitney)|||The sample selected for this study,70 per drug group (or 10 in each of the 7 groups), achieves 88% power to detect a minimal difference of 4 hours in duration at a significance level (α) of 0.05 and a standard deviation of 3 hours using Williams test. We chose a difference of 4 hours as this was the interval used for assessment in the postoperative period at night. We sought to detect a difference that was equal to 1 observation period difference.||-4.00|-10.00|0.05
71043819|NCT01272921|141597120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0|STANDARD_DEVIATION|0.0||0.05|TWO_SIDED|95.0|-7.0|-2.0|||Wilcoxon (Mann-Whitney)|||The sample selected for this study,70 per drug group (or 10 in each of the 7 groups), achieves 88% power to detect a minimal difference of 4 hours in duration at a significance level (α) of 0.05 and a standard deviation of 3 hours using Williams test. We chose a difference of 4 hours as this was the interval used for assessment in the postoperative period at night. We sought to detect a difference that was equal to 1 observation period difference.||-2.00|-7.00|0.05
71043820|NCT01567826|141597131|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANCOVA|||||||0.01
71043821|NCT01567826|141597132|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANCOVA|||||||0.02
71043822|NCT02062801|141597139|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Chi-squared|||||||0.18
71043823|NCT02062801|141597140|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Chi-squared|||||||0.97
71043824|NCT02062801|141597141|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||Chi-squared|||||||.56
71043825|NCT00868296|141597173|SUPERIORITY_OR_OTHER|||||||0.857||||||Analysis with treatment as factor; baseline as covariate|ANCOVA|||Between group comparison for change from baseline in length z-score.||||0.857
71043826|NCT00868296|141597173|SUPERIORITY_OR_OTHER|||||||0.901||||||Analysis with treatment as factor; baseline as covariate|ANCOVA|||Between group comparison for change from baseline in weight z-score.||||0.901
71043827|NCT00868296|141597173|SUPERIORITY_OR_OTHER|||||||0.807||||||Analysis with treatment as factor; baseline as covariate|ANCOVA|||Between group comparison for change from baseline in head circumference z-score.||||0.807
71043828|NCT00868296|141597173|SUPERIORITY_OR_OTHER|||||||0.595|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for length z-score.||||0.595
71101270|NCT02579759|141710623|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.16||0.084|TWO_SIDED|97.5|-0.65|0.08|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.08|-0.65|0.084
71101271|NCT02579759|141710623|SUPERIORITY||Slope|-0.22|STANDARD_ERROR_OF_MEAN|0.09||0.015|TWO_SIDED|95.0|-0.41|-0.04|||Regression, Linear|||"Dose effect:~Dose is defined as a numerical variable proportional to quantity of PXT3003 administered (0 for Placebo, 1 for Dose 1, 2 for Dose 2).~The analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA assessing the dose-effect at the mean of 12 and 15 months, adjusting for baseline value and assuming centre as random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||-0.04|-0.41|0.015
71043829|NCT00868296|141597173|SUPERIORITY_OR_OTHER|||||||0.016|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for length z-score.||||0.016
71043830|NCT00868296|141597173|SUPERIORITY_OR_OTHER|||||||0.347|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for weight z-score.||||0.347
71043831|NCT00868296|141597173|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for weight z-score.||||0.040
71043832|NCT00868296|141597173|SUPERIORITY_OR_OTHER|||||||0.892|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for head circumference z-score.||||0.892
71043833|NCT00868296|141597173|SUPERIORITY_OR_OTHER|||||||0.006|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for head circumference z-score.||||0.006
71043834|NCT02075606|141597182|OTHER||Odds Ratio (OR)|0.17|||=|0.126|TWO_SIDED|95.0|0.02|1.65|||Regression, Logistic|||Clinical symptomatic response as dependent variable and CTC presence at baseline as explanatory variable was used to perform the logistic regression analysis.||1.65|0.02|=0.126
71043835|NCT02462486|141597189|NON_INFERIORITY|For hypothesis testing, if the lower limit of the 95.1% confidence interval for the difference between an abicipar group and ranibizumab is greater than or equal to -10%, non-inferiority of abicipar group is established.|Percentage Difference|-1.2|||||TWO_SIDED|95.0|-5.0|2.4|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as stratification factor.|||2.4|-5.0|
71043836|NCT02462486|141597189|NON_INFERIORITY|For hypothesis testing, if the lower limit of the 95.1% confidence interval for the difference between an abicipar group and ranibizumab is greater than or equal to -10%, non-inferiority of abicipar group is established.|Percentage Difference|-4.6|||||TWO_SIDED|95.0|-9.0|-0.5|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as stratification factor.|||-0.5|-9.0|
71043837|NCT02462486|141597190|NON_INFERIORITY|For hypothesis testing, non-inferiority of abicipar is established if the lower limit of the CI is \> - 5.0 letters.|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.1|-2.4|2.0|||||MMRM included treatment, region, BL BCVA, BL CRT ≤400 or \>400, choroidal neovascularization lesion type, visit, visit-by-BL BCVA interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.|||2.0|-2.4|
71043838|NCT02462486|141597190|NON_INFERIORITY|For hypothesis testing, non-inferiority of abicipar is established if the lower limit of the CI is \> - 5.0 letters.|Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.1|-3.8|0.6|||||MMRM included treatment, region, BL BCVA, BL CRT ≤400 or \>400, choroidal neovascularization lesion type, visit, visit-by-BL BCVA interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.|||0.6|-3.8|
71043839|NCT02462486|141597191|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|Least Squares Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.1|-7.1|14.0|||||MMRM included treatment, region, BL BCVA, BL CRT, choroidal neovascularization lesion type, visit, visit-by-baseline CRT interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.|||14.0|-7.1|
71043840|NCT02462486|141597191|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|Least Squares Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.1|-4.7|16.5|||||MMRM included treatment, region, BL BCVA, BL CRT, choroidal neovascularization lesion type, visit, visit-by-baseline CRT interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.|||16.5|-4.7|
71043841|NCT02462486|141597192|SUPERIORITY||Percentage Difference|1.4|||||TWO_SIDED|95.0|-5.5|8.4|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as the stratification factor.|||8.4|-5.5|
71043842|NCT02462486|141597192|SUPERIORITY||Percentage Difference|-2.3|||||TWO_SIDED|95.0|-9.1|4.5|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as the stratification factor.|||4.5|-9.1|
71043843|NCT02462486|141597193|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.1|-3.5|0.3|||||MMRM included treatment group, region, baseline BCVA in the study eye, baseline VFQ score, visit, and treatment by visit interaction as fixed covariates using an unstructured covariance matrix.|||0.3|-3.5|
71004229|NCT05083949|141516615|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Ratio of GLSM (%)|99.57|STANDARD_DEVIATION|5.23||0.7792|TWO_SIDED|90.0|97.03|102.19|||ANOVA||"Ratio of Geometric Least Squares Means (GLSM) was calculated as: Fixed dose combination (treatment B)/ free dose combination (treatment A).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||102.19|97.03|0.7792
71004230|NCT05083949|141516616|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Ratio of GLSM (%)|101.36|STANDARD_DEVIATION|10.18||0.6493|TWO_SIDED|90.0|96.39|106.59|||ANOVA||"Ratio of Geometric Least Squares Means (GLSM) was calculated as: Fixed dose combination (treatment B)/ free dose combination (treatment A).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||106.59|96.39|0.6493
71043844|NCT02462486|141597193|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.1|-3.9|-0.1|||||MMRM included treatment group, region, baseline BCVA in the study eye, baseline VFQ score, visit, and treatment by visit interaction as fixed covariates using an unstructured covariance matrix.|||-0.1|-3.9|
71043845|NCT02240186|141597196|SUPERIORITY|||||||0.01|||||||ANOVA|||||||0.01
71043846|NCT02240186|141597197|SUPERIORITY|||||||0.01|||||||ANOVA|||||||0.01
71101272|NCT02579759|141710624|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.28||0.162|TWO_SIDED|97.5|-1.01|0.23|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.23|-1.01|0.162
71043847|NCT02240186|141597198|SUPERIORITY|||||||0.01|||||||ANOVA|||||||0.01
71043848|NCT01682148|141597202|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a responder rate (π) of 63% in the reference group, a clinically relevant delta (Δ) of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|-0.1673||||0.0986|TWO_SIDED|95.0|-0.363|0.0284||Based on a generalised linear model including factors for treatment.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.0284|-0.3630|0.0986
71004231|NCT05083949|141516617|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Ratio of GLSM (%)|101.63|STANDARD_DEVIATION|7.65||0.471|TWO_SIDED|90.0|97.85|105.55|||ANOVA||"Ratio of Geometric Least Squares Means (GLSM) was calculated as: Fixed dose combination (treatment B)/ free dose combination (treatment A).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis of the was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||105.55|97.85|0.4710
71004232|NCT05083949|141516618|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Ratio of GLSM (%)|98.11|STANDARD_DEVIATION|8.14||0.4251|TWO_SIDED|90.0|94.24|102.15|||ANOVA||"Ratio of Geometric Least Squares Means (GLSM) was calculated as: Fixed dose combination (treatment B)/ free dose combination (treatment A).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||102.15|94.24|0.4251
71004233|NCT05083949|141516619|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Ratio of GLSM (%)|99.49|STANDARD_DEVIATION|5.25||0.7379|TWO_SIDED|90.0|96.93|102.11|||ANOVA||"Ratio of Geometric Least Squares Means (GLSM) was calculated as: Fixed dose combination (treatment B)/ free dose combination (treatment A).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||102.11|96.93|0.7379
71004234|NCT05083949|141516620|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Ratio of GLSM (%)|101.24|STANDARD_DEVIATION|7.82||0.5895|TWO_SIDED|90.0|97.4|105.24|||ANOVA||"Ratio of Geometric Least Squares Means (GLSM) was calculated as: Fixed dose combination (treatment B)/ free dose combination (treatment A).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||105.24|97.40|0.5895
71004235|NCT00815776|141516629|NON_INFERIORITY_OR_EQUIVALENCE|The unadjusted reductions are straight arithmetic averages and are supplied for informational purposes only. The pooled variance is calculated from the unadjusted standard deviations, and the t statistic is calculated as described in Laster (2003) using an average sample size of 54 and 106 degrees of freedom.|||||<|0.0096|||||||student's t-test with 2n-2 DoF|||The LS means were used to calculate the test statistic for non-inferiority of the CID to the traditional splint device. The null hypothesis was that the reduction of CMI score for the CID is less than 80% of the reduction in the splint group. A significant p-value(\< 0.05) would reject this null hypothesis in favor of the alternative hypothesis that the CID demonstrated a reduction of at least 80% of that seen in the splint group.||||<0.0096
71004236|NCT00815776|141516630|NON_INFERIORITY_OR_EQUIVALENCE|Safety analyses were performed on the ITT population.||||||0.688|||||||t-test, 1 sided|||Safety analyses were performed on the ITT population. The safety of the CID was characterized by the proportion of subjects with all serious and non-serious study-related adverse events and Unanticipated Adverse Device Events (UADEs). In addition, summaries of the onset, duration, severity, treatment relatedness, and outcome of all adverse events were reported.||||0.688
71004237|NCT00815776|141516631|SUPERIORITY_OR_OTHER|||||||0.2995||||||From the pilot study, 50 subjects (CID arm) and 25 (exercise arm) were required for at least 80% power to detect a difference in the mean reduction in CMI scores between arms if muPassive is less than approximately 70% of that in the CID arm.|t-test, 2 sided|||A significant p-value for the treatment group effect would indicate that the CID group and Exercise group were significantly different, based on results of a two-sided t test for difference in means, with alpha=0.5, and allowing for unequal sample sizes.||||.2995
71004238|NCT02583360|141516633|SUPERIORITY|||||||0.008|||||||Chi-squared|||||||0.008
71004239|NCT02583360|141516634|SUPERIORITY|||||||0.907|||||||t-test, 2 sided|||||||0.907
71004240|NCT02583360|141516635|SUPERIORITY|||||||0.592|||||||t-test, 2 sided|||||||0.592
71004241|NCT04228445|141516636|SUPERIORITY||Odds Ratio (OR)|14.041|||<|0.0001|TWO_SIDED|95.0|7.394|26.662|||Score statistics for Type 3 GEE analysis|||||26.662|7.394|<0.0001
71004242|NCT04228445|141516636|SUPERIORITY||Odds Ratio (OR)|16.772|||<|0.0001|TWO_SIDED|95.0|8.625|32.617|||Score statistics for Type 3 GEE analysis|||||32.617|8.625|<0.0001
71004243|NCT04228445|141516637|OTHER||Percentage of Responders|87.8|||||TWO_SIDED|95.0|78.6|96.9|||||Missing data imputed as non-responder|||96.9|78.6|
71004244|NCT04228445|141516637|OTHER||Percentage of Responders|87.2|||||TWO_SIDED|95.0|77.7|96.8|||||Missing data imputed as non-responder|||96.8|77.7|
71004245|NCT04228445|141516638|OTHER||percentage of satisfaction|89.8|||||TWO_SIDED|95.0|78.2|95.6||||||||95.6|78.2|
71004246|NCT04228445|141516638|OTHER||percentage of satisfaction|80.9|||||TWO_SIDED|95.0|67.5|89.6||||||||89.6|67.5|
71004247|NCT04228445|141516639|OTHER||median time to visualization (minutes)|6.0|||||TWO_SIDED|95.0|5.25|7.0||||||||7.00|5.25|
71004248|NCT04228445|141516639|OTHER||median time to visualization (minutes)|5.93|||||TWO_SIDED|95.0|5.12|7.0||||||||7.00|5.12|
71004249|NCT04228445|141516640|SUPERIORITY||Odds Ratio (OR)|19.532|||<|0.0001|TWO_SIDED|95.0|8.738|43.663|||Score statistics for Type 3 GEE analysis|||||43.663|8.738|<0.0001
71004250|NCT04228445|141516640|SUPERIORITY||Odds Ratio (OR)|15.73|||<|0.0001|TWO_SIDED|95.0|7.199|34.369|||Score statistics for Type 3 GEE analysis|||||34.369|7.199|<0.0001
71004251|NCT04228445|141516641|OTHER||Percentage of Agreement|91.1|||||TWO_SIDED|||||||||Left Ureter||||
71004252|NCT04228445|141516641|OTHER||Percentage of Agreement|88.4|||||TWO_SIDED|||||||||Left Ureter||||
71004253|NCT04228445|141516641|OTHER||Percentage of Agreement|76.1|||||TWO_SIDED|||||||||Left Ureter||||
71004254|NCT04228445|141516641|OTHER||Percentage of Agreement|95.6|||||TWO_SIDED|||||||||Right Ureter||||
71004255|NCT04228445|141516641|OTHER||Percentage of Agreement|86.0|||||TWO_SIDED|||||||||Right Ureter||||
71043849|NCT01682148|141597202|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|-0.1673||||0.5682|TWO_SIDED|95.0|-0.363|0.0284||Based on a generalised linear model including factors for spasticity pattern.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.0284|-0.3630|0.5682
71043850|NCT01682148|141597202|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|-0.1673||||0.8543|TWO_SIDED|5.0|-0.363|0.0284||Based on a generalised linear model including factors for country.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.0284|-0.3630|0.8543
71004256|NCT04228445|141516641|OTHER||Percentage of Agreement|71.6|||||TWO_SIDED|||||||||Right Ureter||||
71004257|NCT04228445|141516642|SUPERIORITY||Odds Ratio (OR)|0.771||||0.4595|TWO_SIDED|95.0|0.388|1.534|||Score statistics for Type 3 GEE analysis|||||1.534|.388|0.4595
71004258|NCT04228445|141516643|SUPERIORITY||Odds Ratio (OR)|1.036||||0.922|TWO_SIDED|95.0|0.509|2.11|||Score statistics for Type 3 GEE analysis|||||2.110|.509|0.9220
71004259|NCT00835276|141516644|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|87.96||||||90.0|80.15|96.53|||||To establish bioequivalence, the mean values for the test product differ by no more than 20% from the respective mean values for the reference listed product.|||96.53|80.15|
71004260|NCT00835276|141516645|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|91.47||||||90.0|85.15|98.26|||||To establish bioequivalence, the mean values for the test product differ by no more that 20% from the repective mean values for the reference listed product.|||98.26|85.15|
71004261|NCT00835276|141516646|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|91.47||||||90.0|85.32|98.07|||||To establish bioequivalence, the mean values for the test product differ by no more than 20% from the respective mean values for the reference listed product.|||98.07|85.32|
71004262|NCT01316380|141516662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.036||0.0005||95.0|0.057|0.199||Step-wise testing for the two treatment groups for the primary endpoint, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.025 (one-sided) for primary endpoint.|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.199|0.057|0.0005
71004263|NCT01316380|141516662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.088|0.23||Step-wise testing for the two treatment groups for the primary endpoint, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.025 (one-sided) for the primary endpoint.|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Tio R2.5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.230|0.088|<0.0001
71004264|NCT01316380|141516663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.122|STANDARD_ERROR_OF_MEAN|0.037||0.001||95.0|0.049|0.194||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.194|0.049|0.001
71004265|NCT01316380|141516663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.037||0.0028||95.0|0.038|0.182||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R2.5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.182|0.038|0.0028
71004266|NCT01316380|141516664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.042||0.1714||95.0|-0.025|0.14||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.140|-0.025|0.1714
71004267|NCT01316380|141516664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.042||0.0119||95.0|0.023|0.188||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R2.5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.188|0.023|0.0119
71004268|NCT01316380|141516665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.034||0.0003||95.0|0.058|0.192||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.192|0.058|0.0003
71004269|NCT01316380|141516665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.149|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.082|0.216||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R2.5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.216|0.082|<0.0001
71004270|NCT01316380|141516666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.039||0.1182||95.0|-0.016|0.138||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.138|-0.016|0.1182
71004271|NCT01316380|141516666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.039||0.0102||95.0|0.024|0.178||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R2.5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.178|0.024|0.0102
71004272|NCT01316380|141516668|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.25||||0.2155||95.0|0.03|2.24||Significance level of alpha=0.05 (two-sided). P-values serve an exploratory function only.|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|Since the percent patients with event is less than 50% the median is not calculable, but Hazard Ratio is still estimable from the Cox model.||2.24|0.03|0.2155
71004273|NCT01316380|141516668|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.53||||0.5071||95.0|0.43|5.44||Significance level of alpha=0.05 (two-sided). P-values serve an exploratory function only.|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|Since the percent patients with event is less than 50% the median is not calculable, but Hazard Ratio is still estimable from the Cox model.||5.44|0.43|0.5071
71004274|NCT01316380|141516669|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.1217||95.0|0.29|1.16||Significance level of alpha=0.05 (two-sided). P-values serve an exploratory function only.|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|Since only 22 of the 155 patients in the placebo group, 21 of the 154 patients in the Tio R2.5 group and 13 of the 155 patients in the Tio R5 group had asthma exacerbations, the median times were not calculable (nc).||1.16|0.29|0.1217
71004275|NCT01316380|141516669|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.8974||95.0|0.53|1.75||Significance level of alpha=0.05 (two-sided). P-values serve an exploratory function only.|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|Since only 22 of the 155 patients in the placebo group, 21 of the 154 patients in the Tio R2.5 group and 13 of the 155 patients in the Tio R5 group had asthma exacerbations, the median times were not calculable (nc). The Hazard Ratio is still estimable from the Cox model.||1.75|0.53|0.8974
71004276|NCT01316380|141516670|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.222|STANDARD_ERROR_OF_MEAN|0.129||0.0872|TWO_SIDED|95.0|-0.032|0.476||p-values serve an exploratory function only|Mixed Models Analysis||Tio R2.5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.|Restricted maximum likelihood (REML)- based repeated measures model was used.||0.476|-0.032|0.0872
71004277|NCT01316380|141516670|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.033|STANDARD_ERROR_OF_MEAN|0.129||0.7995|TWO_SIDED|95.0|-0.287|0.221||p-values serve an exploratory function only|Mixed Models Analysis||Tio R5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.|Restricted maximum likelihood (REML)- based repeated measures model was used.||0.221|-0.287|0.7995
71004278|NCT01316380|141516671|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.097|STANDARD_ERROR_OF_MEAN|0.076||0.2038|TWO_SIDED|95.0|-0.053|0.247||p-values serve an exploratory function only|Mixed Models Analysis||Tio R2.5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.|Restricted maximum likelihood (REML)- based repeated measures model was used. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.||0.247|-0.053|0.2038
71004279|NCT01316380|141516671|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.009|STANDARD_ERROR_OF_MEAN|0.076||0.9104|TWO_SIDED|95.0|-0.158|0.141||p-values serve an exploratory function only|Mixed Models Analysis||Tio R5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.|Restricted maximum likelihood (REML)- based repeated measures model was used.||0.141|-0.158|0.9104
71004280|NCT01316380|141516672|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.131|STANDARD_ERROR_OF_MEAN|0.068||0.0559|TWO_SIDED|95.0|-0.003|0.265||p-values serve an exploratory function only|Mixed Models Analysis||Tio R2.5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.|Restricted maximum likelihood (REML)- based repeated measures model was used.||0.265|-0.003|0.0559
71004281|NCT01316380|141516672|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.068||0.8795|TWO_SIDED|95.0|-0.144|0.123||p-values serve an exploratory function only|Mixed Models Analysis||Tio R5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.|Restricted maximum likelihood (REML)- based repeated measures model was used.||0.123|-0.144|0.8795
71004282|NCT01307046|141516687|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-5.1|||<|0.001|TWO_SIDED|95.0|-6.8|-3.4|||constrained longitudinal data analysis|||||-3.4|-6.8|<.001
71004283|NCT01307046|141516688|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-9.2|||<|0.001|TWO_SIDED|95.0|-11.9|-6.5|||constrained longitudinal data analysis|||||-6.5|-11.9|<.001
71043851|NCT01682148|141597202|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|-0.1673||||0.9167|TWO_SIDED|95.0|-0.363|0.0284||Based on a generalised linear model including factors for MAS at Baseline.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.0284|-0.3630|0.9167
71043852|NCT01682148|141597202|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|0.0707||||0.6052|TWO_SIDED|95.0|-0.1948|0.3362||Based on a generalised linear model including factors for treatment.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.3362|-0.1948|0.6052
71043853|NCT01682148|141597202|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|0.0707||||0.5369|TWO_SIDED|95.0|-0.1948|0.3362||Based on a generalised linear model including factors for spasticity pattern.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.3362|-0.1948|0.5369
71043854|NCT01682148|141597202|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|0.0707||||0.7732|TWO_SIDED|95.0|-0.1948|0.3362||Based on a generalised linear model including factors for country.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.3362|-0.1948|0.7732
71043855|NCT01682148|141597202|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|0.0707||||0.1758|TWO_SIDED|95.0|-0.1948|0.3362||Based on a generalised linear model including factors for MAS at Baseline.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.3362|-0.1948|0.1758
71043856|NCT01682148|141597204|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|-0.1324||||0.24|TWO_SIDED|95.0|-0.3531|0.0884||Based on a generalised linear model including factors for treatment, spasticity pattern, country and MAS baseline score.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.0884|-0.3531|0.2400
71043857|NCT01682148|141597205|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9448|TWO_SIDED|95.0|||||ANOVA|Analysis of variance (ANOVA) included factors for treatment, spasticity pattern and country, and Baseline VAS as a covariate.||Mean change in VAS from Baseline to Week 4.||||0.9448
71043858|NCT01682148|141597205|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5458|||||||ANOVA|ANOVA included factors for treatment, spasticity pattern and country, and Baseline VAS as a covariate.||Mean change in VAS from Baseline to Week 12.||||0.5458
71043859|NCT01682148|141597206|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4006|||||||ANOVA|ANOVA included factors for treatment, spasticity pattern and country.||||||0.4006
71043860|NCT01682148|141597207|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5747|||||||Mann-Whitney U-test|||||||0.5747
71043861|NCT01682148|141597208|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1802|||||||Mann-Whitney U-test|||||||0.1802
71101273|NCT02579759|141710624|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.23||0.556|TWO_SIDED|97.5|-0.66|0.39|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.39|-0.66|0.556
71101274|NCT02579759|141710624|SUPERIORITY||Slope|-0.17|STANDARD_ERROR_OF_MEAN|0.13||0.204|TWO_SIDED|95.0|-0.43|0.09|||Regression, Linear|||"Dose is defined as a numerical variable proportional to quantity of PXT3003 administered (0 for Placebo, 1 for Dose 1, 2 for Dose 2).~The analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA assessing the dose-effect at the mean of 12 and 15 months, adjusting for baseline value and assuming centre as random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.09|-0.43|0.204
71101275|NCT02579759|141710625|SUPERIORITY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.36||0.232|TWO_SIDED|97.5|-1.25|0.38|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.38|-1.25|0.232
70924684|NCT04321031|141342045|SUPERIORITY||Risk Difference (RD)|0.03|||||TWO_SIDED|90.0|-0.01|0.08|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.08|-0.01|
71004284|NCT02574520|141516699|SUPERIORITY|Primary|Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.24||0.124|TWO_SIDED|95.0|-0.84|0.1|||ANOVA|Mixed model with repeated measures (MMRM) for scheduled pain measurements was estimated with time as a repeating factor within subject.|Least squares mean from the MMRM described in the Statistical Test of Hypothesis.|Pain Intensity on Movement 0-48 hr||0.10|-0.84|0.124
71004285|NCT02550093|141516706|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||HEAT||||.47
71004286|NCT02550093|141516706|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||COLD||||0.70
71004287|NCT02550093|141516707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||HEAT||||0.84
71004288|NCT02550093|141516707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||COLD||||0.95
71004289|NCT02550093|141516708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||HEAT||||0.92
71004290|NCT02550093|141516708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||COLD||||0.63
71004291|NCT02550093|141516709|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.60
71043862|NCT04740931|141597226|NON_INFERIORITY|If the lower bound of a two-sided 95% confidence interval (CI) for the difference in adjusted means of the two treatments (faricimab minus aflibercept) is greater than -4 letters (the non-inferiority margin), then faricimab is considered non-inferior to aflibercept.|Difference in Adjusted Means|-0.4|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|95.0|-2.5|1.6|||||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|The null hypothesis, H0: μ(faricimab) - μ(aflibercept) ≤-4 letters; the alternative hypothesis, Ha: μ(faricimab) - μ(aflibercept) \>-4 letters. The final sample size provided \>90% power for the non-inferiority assessment (at a one-sided 0.02485 significance level).||1.6|-2.5|
70924685|NCT04321031|141342045|SUPERIORITY||Risk Difference (RD)|0.04|||||TWO_SIDED|90.0|-0.02|0.09|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.09|-0.02|
71004292|NCT02550093|141516710|SUPERIORITY_OR_OTHER_LEGACY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
71004293|NCT02550093|141516711|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||||||0.62
71004294|NCT02550093|141516712|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
71004295|NCT02550093|141516713|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
71004296|NCT02550093|141516714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||||||0.61
71004297|NCT02550093|141516715|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||||||0.71
71004298|NCT02550093|141516716|SUPERIORITY_OR_OTHER_LEGACY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
71004299|NCT02550093|141516717|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.75
71004300|NCT01365091|141516718|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 1: The corresponding power and coefficient of variation between test and reference drugs are 98% and 17.24%, respectively|Geometric mean ratio|95.204|||||TWO_SIDED|90.0|87.618|103.446|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||103.446|87.618|
71004301|NCT01365091|141516718|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 1: The corresponding power and coefficient of variation are 80% and 22.62%, respectively.|Geometric mean ratio|107.606|||||TWO_SIDED|90.0|96.552|119.924|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||119.924|96.552|
71004302|NCT01365091|141516718|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 1: The corresponding power and the coefficient of variation are 99% and 16.26%, respectively.|Geometric mean ratio|104.373|||||TWO_SIDED|90.0|96.504|112.883|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B= FDC (test value)|||112.883|96.504|
71004303|NCT01365091|141516718|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 2: The corresponding power and the variation coefficient are 81% and 14.42%,respectively.|Geometric mean ratio|88.188|||||TWO_SIDED|90.0|82.368|94.419|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||94.419|82.368|
71004304|NCT01365091|141516718|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 2: The corresponding power and the variation coefficient are 99% and 13.09%, respectively.|Geometric mean ratio|98.168|||||TWO_SIDED|90.0|92.263|104.451|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||104.451|92.263|
71004305|NCT01365091|141516718|NON_INFERIORITY_OR_EQUIVALENCE|5-OH saxagliptin, Arm 2: The corresponding power and the variation coefficient are 99% and 8.02%, respectively.|Geometric mean ratio|95.023|||||TWO_SIDED|90.0|91.47|98.714|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||98.714|91.470|
71004306|NCT01365091|141516718|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 3: The corresponding power and the variation coefficient are 99% and 15.55%, respectively.|Geometric mean ratio|97.601|||||TWO_SIDED|90.0|15.55|99.0|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||99|15.55|
71004307|NCT01365091|141516718|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 3: The corresponding power and the variation coefficient are 84% and 15.65%, respectively.|Geometric mean ratio|110.656|||||TWO_SIDED|90.0|102.416|119.559|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||119.559|102.416|
71004308|NCT01365091|141516718|NON_INFERIORITY_OR_EQUIVALENCE|OH-Saxagliptin, Arm 3: The corresponding power and the variation coefficient are 99% and 12.61%, respectively.|Geometric mean ratio|106.264|||||TWO_SIDED|90.0|99.826|113.117|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||113.117|99.826|
71101276|NCT02579759|141710625|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.31||0.868|TWO_SIDED|97.5|-0.74|0.64|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.64|-0.74|0.868
71101277|NCT02579759|141710625|SUPERIORITY||Slope|-0.18|STANDARD_ERROR_OF_MEAN|0.18||0.322|TWO_SIDED|95.0|-0.53|0.17|||Regression, Linear|||"Dose is defined as a numerical variable proportional to quantity of PXT3003 administered (0 for Placebo, 1 for Dose 1, 2 for Dose 2).~The analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA assessing the dose-effect at the mean of 12 and 15 months, adjusting for baseline value and assuming centre as random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.17|-0.53|0.322
71101278|NCT02579759|141710626|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.46||0.377|TWO_SIDED|97.5|-1.43|0.62|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.62|-1.43|0.377
71004309|NCT01365091|141516718|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 4: The corresponding power and the variation coefficient are 99% and 10.30%, respectively.|Geometric mean ratio|100.028|||||TWO_SIDED|90.0|95.164|105.139|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||105.139|95.164|
71004310|NCT01365091|141516718|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 4: The corresponding power and the variation coefficient are 99% and 10.38%, respectively.|Geometric mean ratio|93.644|||||TWO_SIDED|95.0|89.055|98.47|||ANCOVA|Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||98.470|89.055|
71004311|NCT01365091|141516719|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 1: The corresponding power and coefficient of variation are 98% and 17.24%, respectively.|Geometric mean ratio|91.508|||||TWO_SIDED|90.0|82.596|101.38|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||101.380|82.596|
71004312|NCT01365091|141516719|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 1: The corresponding power and the coefficient of variation are 99% and 07.66%, respectively.|Geometric mean ratio|97.437|||||TWO_SIDED|90.0|93.889|101.119|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||101.119|93.889|
71004313|NCT01365091|141516719|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 1: The corresponding power and the coefficient of variation are 99% and 07.43%, respectively.|Geometric mean ratio|96.77|||||TWO_SIDED|90.0|93.35|100.316|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||100.316|93.350|
71004314|NCT01365091|141516719|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 2: The corresponding power and the variation coefficient are 96% and 14.37%, respectively.|Geometric mean ratio|91.585|||||TWO_SIDED|90.0|85.56|98.035|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||98.035|85.56|
71004315|NCT01365091|141516719|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 2: The corresponding power and the variation coefficient are 96.028% and 101.095%, respectively.|Geometric mean ratio|98.529|||||TWO_SIDED|90.0|96.028|101.095|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||101.095|96.028|
71004316|NCT01365091|141516719|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 2: The corresponding power and the variation coefficient are 99% and 6.55%, respectively|Geometric mean ratio|96.239|||||TWO_SIDED|90.0|93.286|99.286|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||99.286|93.286|
71004317|NCT01365091|141516719|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 3: The corresponding power and the variation coefficient are 99% and 12.19%, respectively.|Geometric mean ratio|102.994|||||TWO_SIDED|90.0|96.956|109.407|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||109.407|96.956|
71004318|NCT01365091|141516719|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 3: The corresponding power and the variation coefficient are 99% and 7.07%, respectively.|Geometric mean ratio|97.135|||||TWO_SIDED|95.0|93.778|100.613|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||100.613|93.778|
71004319|NCT01365091|141516719|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 3: The corresponding power and the variation coefficient are 99% and 7.18%, respectively.|Geometric mean ratio|100.01|||||TWO_SIDED|90.0|96.512|103.648|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||103.648|96.512|
71004320|NCT01365091|141516719|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 1:The corresponding power and the variation coefficient are 93% and 17.35%, respectively.|Geometric mean ratio|92.953|||||TWO_SIDED|90.0|85.502|101.053|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||101.053|85.502|
71004321|NCT01365091|141516719|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 4: The corresponding power and the variation coefficient are 99% and 5.75%, respectively.|Geometric mean ratio|101.281|||||TWO_SIDED|95.0|98.494|104.147|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||104.147|98.494|
71043863|NCT04740931|141597226|SUPERIORITY||Difference in Adjusted Means|-0.4|STANDARD_ERROR_OF_MEAN|1.04||0.6715|TWO_SIDED|95.0|-2.5|1.6||Tested at a two-sided p\<0.0497 significance level.|Mixed Model of Repeated Measures||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|The final sample size provided \>80% power for a 3.5-letter superiority assessment of faricimab over aflibercept (at a two-sided 0.0497 significance level).||1.6|-2.5|0.6715
71043864|NCT04740931|141597228|OTHER||Difference in CMH Weighted Percentage|-1.5|||||TWO_SIDED|95.0|-8.4|5.3||||||||5.3|-8.4|
71043865|NCT04740931|141597244|OTHER||Difference in Adjusted Means|-1.2|STANDARD_ERROR_OF_MEAN|0.77|||TWO_SIDED|95.0|-2.7|0.3||||||||0.3|-2.7|
71043866|NCT01103479|141597303|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.65||||0.32|TWO_SIDED|95.0|0.62|4.38||Random effects model adjusting for clustering by clinic|Mixed Models Analysis|||||4.38|0.62|0.32
71043867|NCT01103479|141597304|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.8||||0.28|TWO_SIDED|95.0|0.53|1.2||Linear model adjusting for stratification by clinic and participant age|Mixed Models Analysis|||||1.20|0.53|0.28
71043868|NCT01103479|141597305|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.43||||0.42|TWO_SIDED|95.0|0.6|3.43||Random effects model adjusted for clustering by clinic|Mixed Models Analysis|||||3.43|0.60|0.42
71043869|NCT01103479|141597306|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.05||||0.38|TWO_SIDED|95.0|0.94|1.18||Linear model adjusting for stratification by clinic and participant age|Mixed Models Analysis|||||1.18|0.94|0.38
71043870|NCT00605917|141597312|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was starting dose. The null hypothesis is there is no difference between three types of starting dose in the participants of responders."||||<0.001
71043871|NCT00605917|141597313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was concomitant drug. The null hypothesis is there is no difference between with and without concomitant drug in the participants of responders."||||0.002
71043872|NCT00605917|141597314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.032|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was family history of psychiatric disorder. The null hypothesis is there is no difference between with and without family history of psychiatric disorder in the participants of responders."||||0.032
71043873|NCT00605917|141597315|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was smoking status. The null hypothesis is there is no difference between three types of smoking status in the participants of responders."||||<0.001
71043874|NCT00605917|141597316|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was past medical history of other illness. The null hypothesis is there is no difference between with and without past medical history of other illness in the participants of responders."||||<0.001
71101279|NCT02579759|141710626|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.38||0.334|TWO_SIDED|97.5|-1.21|0.48|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.48|-1.21|0.334
71101280|NCT02579759|141710626|SUPERIORITY||Slope|-0.19|STANDARD_ERROR_OF_MEAN|0.22||0.373|TWO_SIDED|95.0|-0.62|0.23|||Regression, Linear|||"Dose is defined as a numerical variable proportional to quantity of PXT3003 administered (0 for Placebo, 1 for Dose 1, 2 for Dose 2).~The analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA assessing the dose-effect at the mean of 12 and 15 months, adjusting for baseline value and assuming centre as random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.23|-0.62|0.373
71043875|NCT00605917|141597317|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was non-pharmaceutical therapies. The null hypothesis is there is no difference between with and without non-pharmaceutical therapies in the participants of responders."||||0.001
71043876|NCT00605917|141597318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.028|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was history of treatment prior to administration of Sertraline. The null hypothesis is there is no difference between with and without history of treatment prior to administration of Sertraline in the participants of responders."||||0.028
71043877|NCT00605917|141597319|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was average daily dose. The null hypothesis is there is no difference of five types of average daily dose in the participants of responders."||||<0.001
71101281|NCT02579759|141710630|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.13||0.023|TWO_SIDED|97.5|-0.58|0.0|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0|-0.58|0.023
71043878|NCT00605917|141597320|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|TWO_SIDED|||||"The risk factor tested was complications. The null hypothesis is there is no difference between with and without complications in the participants of responders."|Chi-squared|not adjusted, p=0.050||"The risk factor tested was complications. The null hypothesis is there is no difference between with and without complications in the participants of responders."||||0.030
71043879|NCT00605917|141597321|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was concomitant drug. The null hypothesis is there is no difference between with and without concomitant drug in the participants of responders."||||0.013
71043880|NCT00605917|141597322|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was complications. The null hypothesis is there is no difference between with or without complications in the participants of responders."||||0.004
71043881|NCT00605917|141597323|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was drinking status. The null hypothesis is there is no difference between five types of drinking status in the participants of responders."||||0.004
71043882|NCT00440115|141597365|SUPERIORITY|Power calculations demonstrated that 250 participants per group would have 95% power to compare combined high-intensity disease management and moderate-intensity disease management with pharmacotherapy management, on the basis of 10% (pharmacotherapy management), 15% (moderate-intensity disease management), and 25% (high-intensity disease management) self-reported quit rates.|Odds Ratio (OR)|1.12||||0.54|TWO_SIDED|95.0|0.78|1.61|||Mixed Models Analysis||(High-intensity disease management and moderate-intensity disease management) vs pharmacotherapy management|||1.61|0.78|0.54
71043883|NCT00440115|141597365|SUPERIORITY|Power calculations indicated that 250 participants per group would have 80% power to compare high-intensity disease management and moderate-intensity disease management with pharmacotherapy management, on the basis of 10% (pharmacotherapy management), 15% (moderate-intensity disease management), and 25% (high-intensity disease management) self-reported quit rates.|Odds Ratio (OR)|1.33||||0.18|TWO_SIDED|95.0|0.88|2.02|||Mixed Models Analysis||High-intensity disease management vs moderate-intensity disease management|||2.02|0.88|0.18
71043884|NCT02953678|141597393|OTHER||Exact method for binomial distributions|54.9|||||TWO_SIDED|95.0|42.7|66.8||||||||66.8|42.7|
71043885|NCT03535857|141597403|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.546|TWO_SIDED|95.0|||||Pairwise t- test|||||||0.546
71004322|NCT01365091|141516719|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 4: The corresponding power and the variation coefficient are 99% and 5.73%, respectively.|Geometric mean ratio|100.111|||||TWO_SIDED|90.0|97.367|102.932|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||102.932|97.367|
71004323|NCT01365091|141516721|NON_INFERIORITY_OR_EQUIVALENCE|For AUC(0-inf) metformin, Arm 1, the corresponding power and coefficient of variation are 80% and 21.06%, respectively.|Geometric mean ratio|91.494|||||TWO_SIDED|90.0|82.697|101.226|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value).|||101.226|82.697|
71004324|NCT01365091|141516721|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 1: The corresponding power and the coefficient of variation are 99% and 07.60%, respectively.|Geometric mean ratio|97.477|||||TWO_SIDED|90.0|93.955|101.132|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||101.132|93.955|
71004325|NCT01365091|141516721|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 1. The corresponding power and the coefficient of variation are 99% and 07.31%, respectively.|Geometric mean ratio|96.76|||||TWO_SIDED|90.0|93.393|100.247|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value).|||100.247|93.393|
71043886|NCT01730040|141597412|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.1|||<|0.0001|TWO_SIDED|99.0|-55.9|-22.2|||Mixed Models Analysis|Threshold for significance ≤ 0.01.||Alirocumab group was compared to the corresponding active control group using an appropriate contrast statement.||-22.2|-55.9|< 0.0001
71043887|NCT01730040|141597412|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.6|||=|0.0004|TWO_SIDED|99.0|-40.7|-6.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||As described in statistical analysis 1 of the endpoint.||-6.5|-40.7|= 0.0004
71043888|NCT01730040|141597412|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.2|||<|0.0001|TWO_SIDED|99.0|-65.0|-33.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-33.5|-65|< 0.0001
71043889|NCT01730040|141597412|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.6|||<|0.0001|TWO_SIDED|99.0|-48.4|-16.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-16.9|-48.4|< 0.0001
71043890|NCT01730040|141597412|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.4|||<|0.0001|TWO_SIDED|99.0|-47.4|-15.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.4|-47.4|<0.0001
71043891|NCT01730040|141597413|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.5|||<|0.0001|TWO_SIDED|99.0|-59.2|-25.7||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 1% level.||-25.7|-59.2|< 0.0001
71043892|NCT01730040|141597413|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.9|||=|0.0002|TWO_SIDED|99.0|-41.9|-7.8||Threshold for significance≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-7.8|-41.9|= 0.0002
70924686|NCT04321031|141342045|SUPERIORITY||Risk Difference (RD)|0.05|||||TWO_SIDED|90.0|-0.02|0.11|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.11|-0.02|
71004326|NCT01365091|141516721|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 2: The corresponding power and the variation coefficient are 96% and 14.25%, respectively.|Geometric mean ratio|91.548|||||TWO_SIDED|90.0|85.573|97.939|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||97.939|85.573|
71004327|NCT01365091|141516721|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 2: The corresponding power and the variation coefficient are 99% and 5.38%,respectively.|Geometric mean ratio|98.535|||||TWO_SIDED|95.0|96.044|101.09|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||101.090|96.044|
71043893|NCT01730040|141597413|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.8|||<|0.0001|TWO_SIDED|99.0|-69.2|-36.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-36.5|-69.2|< 0.0001
71043894|NCT01730040|141597413|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.0|||<|0.0001|TWO_SIDED|99.0|-51.3|-18.6|||Mixed Models Analysis|Threshold for significance ≤ 0.01.||Analysis description as per the statistical analysis 1 of this endpoint.||-18.6|-51.3|< 0.0001
71043895|NCT01730040|141597413|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.4|||<|0.0001|TWO_SIDED|99.0|-50.0|-16.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-16.8|-50.0|< 0.0001
70924687|NCT04321031|141342045|SUPERIORITY||Risk Difference (RD)|0.05|||||TWO_SIDED|90.0|-0.02|0.12|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.12|-0.02|
70924688|NCT04321031|141342046|SUPERIORITY||Risk Difference (RD)|0.09|||||TWO_SIDED|90.0|-0.01|0.43||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.43|-0.01|
71004328|NCT01365091|141516721|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 2: The corresponding power and the variation coefficient are 99% and 6.52%, respectively.|Geometric mean ratio|96.258|||||TWO_SIDED|95.0|93.319|99.29|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||99.290|93.319|
71004329|NCT01365091|141516721|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 3: The corresponding power and the variation coefficient are 99% and 11.75%, respectively.|Geometric mean ratio|102.383|||||TWO_SIDED|95.0|96.589|108.525|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||108.525|96.589|
71004330|NCT01365091|141516721|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 5: The corresponding power and the variation coefficient are 99% and 7.07%, respectively.|Geometric mean ratio|97.187|||||TWO_SIDED|90.0|93.832|100.662|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||100.662|93.832|
71004331|NCT01365091|141516721|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Sarexagliptin, Arm 3: The corresponding power and the variation coefficient are 99% and 7.08%, respectively.|Geometric mean ratio|100.015|||||TWO_SIDED|95.0|96.56|103.594|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||103.594|96.560|
71043896|NCT01730040|141597414|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.8|||<|0.0001|TWO_SIDED|99.0|-54.0|-25.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-25.6|-54|<0.0001
71043897|NCT01730040|141597414|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.8|||<|0.0001|TWO_SIDED|99.0|-40.0|-11.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-11.6|-40.0|<0.0001
71043898|NCT01730040|141597414|SUPERIORITY_OR_OTHER||LS Mean Difference|-36.0|||<|0.0001|TWO_SIDED|99.0|-47.7|-24.3||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-24.3|-47.7|<0.0001
71043899|NCT01730040|141597414|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.3|||<|0.0001|TWO_SIDED|99.0|-39.2|-15.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.4|-39.2|<0.0001
70924689|NCT04321031|141342046|SUPERIORITY||Risk Difference (RD)|0.03|||||TWO_SIDED|90.0|-0.02|0.29||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.29|-0.02|
70924690|NCT04321031|141342046|SUPERIORITY||Risk Difference (RD)|0.09|||||TWO_SIDED|90.0|-0.01|0.43||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.43|-0.01|
70924691|NCT04321031|141342046|SUPERIORITY||Risk Difference (RD)|0.17|||||TWO_SIDED|90.0|0.01|0.57||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.57|0.01|
71004332|NCT01365091|141516721|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 4: The corresponding power and the variation coefficient are 94% and 17.13%, respectively.|Geometric mean ratio|93.219|||||TWO_SIDED|90.0|85.835|101.238|||ANCOVA|||||101.238|85.835|
71004333|NCT01365091|141516721|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 4: The corresponding power and the variation coefficient are 99% and 5.72%, respectively.|Geometric mean ratio|101.346|||||TWO_SIDED|90.0|98.574|104.196|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||104.196|98.574|
71004334|NCT01365091|141516721|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 4: The corresponding power and the variation coefficient are 99% and 5.71%, respectively.|Geometric mean ratio|100.056|||||TWO_SIDED|90.0|97.324|102.864|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||102.864|97.324|
71004335|NCT01388491|141516766|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-11.8||||0.5892|TWO_SIDED|95.0|-54.75|31.17||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||31.17|-54.75|0.5892
71004336|NCT01388491|141516767|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|3.0||||0.839|TWO_SIDED|95.0|-25.96|31.94||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||31.94|-25.96|0.839
71043900|NCT01730040|141597414|SUPERIORITY_OR_OTHER||LS Mean Difference|-20.9|||<|0.0001|TWO_SIDED|99.0|-32.8|-8.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-8.9|-32.8|<0.0001
71043901|NCT01730040|141597415|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.5|||<|0.0001|TWO_SIDED|99.0|-55.8|-33.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-33.1|-55.8|<0.0001
71043902|NCT01730040|141597415|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.6|||<|0.0001|TWO_SIDED|99.0|-38.0|-15.2||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.2|-38.0|<0.0001
71004337|NCT01388491|141516768|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-4.8||||0.0021|TWO_SIDED|95.0|-7.87|-1.77||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||-1.77|-7.87|0.0021
71004338|NCT01388491|141516769|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|3.2||||0.2312|TWO_SIDED|95.0|-2.08|8.58||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||8.58|-2.08|0.2312
71043903|NCT01730040|141597415|SUPERIORITY_OR_OTHER||LS Mean Difference|-36.3|||<|0.0001|TWO_SIDED|99.0|-48.1|-24.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-24.5|-48.1|<0.0001
71043904|NCT01730040|141597415|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.7|||<|0.0001|TWO_SIDED|99.0|-39.6|-15.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.8|-39.6|<0.0001
71043905|NCT01730040|141597415|SUPERIORITY_OR_OTHER||LS Mean Difference|-20.2|||<|0.0001|TWO_SIDED|99.0|-32.2|-8.2||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-8.2|-32.2|<0.0001
71043906|NCT01730040|141597416|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.3|||<|0.0001|TWO_SIDED|99.0|-42.0|-16.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-16.6|-42.0|<0.0001
71043907|NCT01730040|141597416|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.6|||<|0.0001|TWO_SIDED|99.0|-36.6|-10.7||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-10.7|-36.6|<0.0001
71043908|NCT01730040|141597416|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.4|||<|0.0001|TWO_SIDED|99.0|-50.8|-26.0||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-26.0|-50.8|<0.0001
71043909|NCT01730040|141597416|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.9|||<|0.0001|TWO_SIDED|99.0|-43.2|-18.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-18.6|-43.2|<0.0001
71043910|NCT01730040|141597416|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.6|||<|0.0001|TWO_SIDED|99.0|-40.1|-15.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.1|-40.1|<0.0001
71043911|NCT01730040|141597417|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.6|||<|0.0001|TWO_SIDED|99.0|-44.6|-20.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-20.6|-44.6|<0.0001
71101282|NCT02579759|141710630|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.11||0.162|TWO_SIDED|97.5|-0.4|0.09|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.09|-0.4|0.162
71101283|NCT02579759|141710634|SUPERIORITY||Odds Ratio (OR)|2.09||||0.097|TWO_SIDED|97.5|0.77|5.68|||General Linear Mixed Model|||The proportion of responders (on Completers selection only) at the end of treatment was assessed through a Generalized Linear Mixed Model (GLMM) featuring logistic regression including treatment as a fixed effect, adjusting for the baseline value and center as a random effect.||5.68|0.77|0.097
71043912|NCT01730040|141597417|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.1|||<|0.0001|TWO_SIDED|99.0|-37.3|-12.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-12.8|-37.3|<0.0001
71101284|NCT02579759|141710634|SUPERIORITY||Odds Ratio (OR)|1.07||||0.865|TWO_SIDED|97.5|0.42|2.7|||General Linear Mixed Model|||The proportion of responders (on Completers selection only) at the end of treatment was assessed through a Generalized Linear Mixed Model (GLMM) featuring logistic regression including treatment as a fixed effect, adjusting for the baseline value and center as a random effect.||2.7|0.42|0.865
71004339|NCT01388491|141516770|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.6||||0.344|TWO_SIDED|95.0|-1.7|4.85||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||4.85|-1.70|0.3440
71004340|NCT01388491|141516771|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.3||||0.2522|TWO_SIDED|95.0|-0.24|0.92||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||0.92|-0.24|0.2522
71043913|NCT01730040|141597417|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.3|||<|0.0001|TWO_SIDED|99.0|-51.2|-25.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-25.4|-51.2|<0.0001
71043914|NCT01730040|141597417|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.8|||<|0.0001|TWO_SIDED|99.0|-42.6|-17.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-17.1|-42.6|<0.0001
71004341|NCT01388491|141516772|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|2.9||||0.0143|TWO_SIDED|95.0|0.58|5.13||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||5.13|0.58|0.0143
71004342|NCT01388491|141516773|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.5||||0.8507|TWO_SIDED|95.0|-4.87|5.91||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||5.91|-4.87|0.8507
71004343|NCT01388491|141516774|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.1||||0.0459|TWO_SIDED|95.0|0.0|0.14||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||0.14|0.00|0.0459
71004344|NCT01388491|141516775|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.1||||0.0318|TWO_SIDED|95.0|0.01|0.26||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||0.26|0.01|0.0318
71004345|NCT01388491|141516776|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|361.6||||0.1148|TWO_SIDED|95.0|-88.45|811.61||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||811.61|-88.45|0.1148
71004346|NCT01388491|141516777|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|8.2||||0.7136|TWO_SIDED|95.0|-35.92|52.39||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||52.39|-35.92|0.7136
71004347|NCT01388491|141516778|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.1||||0.3903|TWO_SIDED|95.0|-0.29|0.11||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||0.11|-0.29|0.3903
71004348|NCT01388491|141516779|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|14.3||||0.1731|TWO_SIDED|95.0|-6.29|34.8||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||34.80|-6.29|0.1731
71004349|NCT04964557|141516800|SUPERIORITY||Mean Difference (Final Values)|-62.3|||<|0.001|TWO_SIDED|95.0|-68.0|-56.6|||ANCOVA|||||-56.6|-68|<0.001
71004350|NCT04964557|141516801|SUPERIORITY||Mean Difference (Final Values)|-76.7|||<|0.001|TWO_SIDED|95.0|-81.7|-71.7|||ANCOVA|||||-71.7|-81.7|<0.001
71101285|NCT02579759|141710635|SUPERIORITY||Odds Ratio (OR)|3.39||||0.026|TWO_SIDED|97.5|0.99|11.62|||General Linear Mixed Model|||The proportion of responders (on Completers selection only) at the end of treatment was assessed through a Generalized Linear Mixed Model (GLMM) featuring logistic regression including treatment as a fixed effect, adjusting for the baseline value and center as a random effect.||11.62|0.99|0.026
71101286|NCT02579759|141710635|SUPERIORITY||Odds Ratio (OR)|1.26||||0.569|TWO_SIDED|97.5|0.5|3.16|||General Linear Mixed Model|||The proportion of responders (on Completers selection only) at the end of treatment was assessed through a Generalized Linear Mixed Model (GLMM) featuring logistic regression including treatment as a fixed effect, adjusting for the baseline value and center as a random effect.||3.16|0.5|0.569
71004351|NCT03649815|141516827|OTHER|||||||0.067|||||||Paired Sample T-Test|||||||0.067
71004352|NCT03649815|141516827|OTHER|||||||0.071||||||Controlled for gender, age, and baseline symptomatology|Paired Sample T-Test|||||||0.071
71004353|NCT03649815|141516828|OTHER|||||||0.047|||||||Paired Sample T-Test|||||||0.047
71004354|NCT03649815|141516828|OTHER|||||||0.036||||||Controlled for gender, age and baseline symptomatology|Paired Sample T-Test|||||||0.036
71004355|NCT03649815|141516829|OTHER|||||||0.032|||||||Paired Sample T-Test|||||||0.032
71004356|NCT03649815|141516829|OTHER|||||||0.006||||||Controlled for gender, age and baseline symptomatology|Paired Sample T-Test|||||||0.006
71004357|NCT05241470|141516833|SUPERIORITY||Mean Difference (Net)|0.01||||0.9575|TWO_SIDED||||||ANCOVA|||||||0.9575
71004358|NCT05241470|141516833|SUPERIORITY||Mean Difference (Net)|0.01||||0.9741|TWO_SIDED||||||ANCOVA|||||||0.9741
71004359|NCT05241470|141516834|SUPERIORITY|||||||0.5696|||||||ANCOVA|||||||0.5696
71004360|NCT05241470|141516835|SUPERIORITY|||||||0.0266|||||||Fisher Exact|||||||0.0266
71004361|NCT05241470|141516836|SUPERIORITY|||||||0.0055|||||||ANCOVA|||||||0.0055
71004362|NCT05241470|141516837|SUPERIORITY|||||||0.0097|||||||ANCOVA|||||||0.0097
71004363|NCT05241470|141516838|SUPERIORITY|||||||0.0137|||||||ANCOVA|||||||0.0137
71004364|NCT05241470|141516839|SUPERIORITY|||||||0.0332|||||||ANCOVA|||||||0.0332
71004365|NCT05241470|141516840|SUPERIORITY|||||||0.0394|||||||t-test, 2 sided|||||||0.0394
71004366|NCT05241470|141516841|SUPERIORITY|||||||0.0121|||||||Wilcoxon (Mann-Whitney)|||||||0.0121
71004367|NCT05241470|141516842|SUPERIORITY|||||||0.0224|||||||Wilcoxon (Mann-Whitney)|||||||0.0224
71004368|NCT04960202|141516874|SUPERIORITY||Percentage difference|-6.137|STANDARD_ERROR_OF_MEAN|1.057|<|0.0001|TWO_SIDED|95.0|-8.208|-4.066|||Normal approximation|||The difference of the percentage in the 2 treatment groups and its 95% confidence interval, and p-value based on Normal approximation of the data are presented.||-4.066|-8.208|<0.0001
71101287|NCT02410200|141710638|SUPERIORITY_OR_OTHER|||||||0.009|||||||Wilcoxon Signed Rank test|||||||0.0090
71101288|NCT00456365|141710724|SUPERIORITY_OR_OTHER|||||||0.03|||||||Chi-squared|||||||0.03
71004369|NCT04960202|141516877|SUPERIORITY||Percentage difference|-5.638|STANDARD_ERROR_OF_MEAN|0.852|<|0.0001|TWO_SIDED|95.0|-7.308|-3.967|||Normal approximation|||The difference of the percentage in the 2 treatment groups and its 95% confidence interval, and p-value based on Normal approximation of the data are presented.||-3.967|-7.308|<0.0001
71004370|NCT04960202|141516878|SUPERIORITY||Hazard Ratio (HR)|1.294||||0.0003|TWO_SIDED|95.0|1.136|1.476|||Cox Proportional Hazard Model|||Analysis of treatment effect on time to sustained alleviation is based on Cox proportional hazard (PH) model with treatment and geographic region effects as independent variables, and baseline SARS-CoV-2 serology status and baseline viral load (\<4 logarithm to base 10 \[log10\] copies/milliliter \[mL\], \>=4 log10 copies/mL) as covariates.||1.476|1.136|0.0003
71004371|NCT04960202|141516879|SUPERIORITY||Hazard Ratio (HR)|1.266|||<|0.0001|TWO_SIDED|95.0|1.134|1.412|||Cox Proportional Hazard Model|||Analysis of treatment effect on time to sustained alleviation is based on Cox PH model with treatment and geographic region effects as independent variables, and symptom onset duration (\<=3, \>3), baseline SARS-CoV-2 serology status and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL) as covariates.||1.412|1.134|<0.0001
71004372|NCT04960202|141516880|SUPERIORITY||Hazard Ratio (HR)|1.258|||<|0.0001|TWO_SIDED|95.0|1.131|1.4|||Cox Proportional Hazard Model|||Analysis of treatment effect on time to sustained alleviation is based on Cox PH model with treatment and geographic region effects as independent variables, and symptom onset duration (\<=3, \>3), COVID-19 mAb treatment (Yes/No), baseline SARS-CoV-2 serology status and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL) as covariates.||1.400|1.131|<0.0001
71004373|NCT04960202|141516881|SUPERIORITY||Odds Ratio (OR)|0.871||||0.3473|TWO_SIDED|95.0|0.652|1.162|||Regression, Logistic|||Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.162|0.652|0.3473
71004374|NCT04960202|141516882|SUPERIORITY||Odds Ratio (OR)|0.936||||0.5762|TWO_SIDED|95.0|0.74|1.182|||Regression, Logistic|||Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, symptom onset duration (\<=3, \>3), baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.182|0.740|0.5762
71004375|NCT04960202|141516883|SUPERIORITY||Odds Ratio (OR)|0.969||||0.7807|TWO_SIDED|95.0|0.773|1.213|||Regression, Logistic|||Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, symptom onset duration (\<=3, \>3), COVID-19 mAb treatment (Yes/No),baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.213|0.773|0.7807
71004376|NCT04960202|141516884|SUPERIORITY||Hazard Ratio (HR)|1.219||||0.0053|TWO_SIDED|95.0|1.061|1.401|||Cox Proportional Hazard Model|||Analysis of treatment effect on time to sustained resolution is based on Cox PH model with treatment and geographic region effects as independent variables, and baseline SARS-CoV-2 serology status and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL) as covariates.||1.401|1.061|0.0053
71043915|NCT01730040|141597417|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.4|||<|0.0001|TWO_SIDED|99.0|-39.4|-13.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-13.4|-39.4|<0.0001
71043916|NCT01730040|141597418|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.4|||<|0.0001|TWO_SIDED|99.0|-44.7|-16.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-16.1|-44.7|<0.0001
71043917|NCT01730040|141597418|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.6|||=|0.0002|TWO_SIDED|99.0|-36.1|-7.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-7.1|-36.1|=0.0002
71043918|NCT01730040|141597418|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.1|||<|0.0001|TWO_SIDED|99.0|-54.7|-27.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-27.5|-54.7|<0.0001
71043919|NCT01730040|141597418|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.2|||<|0.0001|TWO_SIDED|99.0|-43.7|-16.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-16.6|-43.7|<0.0001
71043920|NCT01730040|141597418|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.6|||<|0.0001|TWO_SIDED|99.0|-40.3|-12.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-12.8|-40.3|<0.0001
71043921|NCT01730040|141597419|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.0|||<|0.0001|TWO_SIDED|99.0|-47.0|-19.0||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-19.0|-47.0|<0.0001
71043922|NCT01730040|141597419|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.4|||<|0.0001|TWO_SIDED|99.0|-36.6|-8.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-8.1|-36.6|<0.0001
71043923|NCT01730040|141597419|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.6|||<|0.0001|TWO_SIDED|99.0|-57.4|-29.7||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-29.7|-57.4|<0.0001
71043924|NCT01730040|141597419|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.1|||<|0.0001|TWO_SIDED|99.0|-46.0|-18.3||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-18.3|-46.0|<0.0001
71043925|NCT01730040|141597419|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.3|||<|0.0001|TWO_SIDED|99.0|-41.4|-13.2||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-13.2|-41.4|<0.0001
71004377|NCT04960202|141516885|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.0022|TWO_SIDED|95.0|1.068|1.348|||Cox Proportional Hazard Model|||Analysis of treatment effect on time to sustained resolution is based on Cox PH model with treatment and geographic region effects as independent variables, and symptom onset duration (\<=3, \>3), baseline SARS-CoV-2 serology status and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL) as covariates.||1.348|1.068|0.0022
71004378|NCT04960202|141516886|SUPERIORITY||Hazard Ratio (HR)|1.194||||0.0021|TWO_SIDED|95.0|1.066|1.337|||Cox Proportional Hazard Model|||Analysis of treatment effect on time to sustained resolution is based on Cox PH model with treatment and geographic region effects as independent variables, and symptom onset duration (\<=3, \>3), COVID-19 mAb treatment (Yes/No), baseline SARS-CoV-2 serology status and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL) as covariates.||1.337|1.066|0.0021
71004379|NCT04960202|141516893|SUPERIORITY||Odds Ratio (OR)|1.088||||0.5293|TWO_SIDED|95.0|0.836|1.416|||Regression, Logistic|||Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.416|0.836|0.5293
71004380|NCT04960202|141516894|SUPERIORITY||Odds Ratio (OR)|1.053||||0.6379|TWO_SIDED|95.0|0.85|1.303|||Regression, Logistic|||Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, symptom onset duration (\<=3, \>3), baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.303|0.850|0.6379
71004381|NCT04960202|141516895|SUPERIORITY||Odds Ratio (OR)|1.046||||0.676|TWO_SIDED|95.0|0.848|1.29|||Regression, Logistic|||Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, symptom onset duration (\<=3, \>3), COVID-19 mAb treatment (Yes/No), baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.290|0.848|0.6760
71004382|NCT04960202|141516896|SUPERIORITY||Odds Ratio (OR)|19.4||||0.1997||95.0|7.788|48.328|||Breslow-Day test||Odds ratio for Day 5 vs Day 1: PF-07321332 300 mg + Ritonavir 100 mg|||48.328|7.788|0.1997
71004383|NCT04960202|141516896|OTHER||Odds Ratio (OR)|8.948|||||TWO_SIDED|95.0|4.159|19.253|||Breslow-Day test||Odds ratio for Day 5 vs Day 1: Placebo|||19.253|4.159|
71004384|NCT04960202|141516897|SUPERIORITY||Odds Ratio (OR)|20.875||||0.281|TWO_SIDED|95.0|10.097|43.156|||Breslow-Day test||Odds ratio for Day 5 vs Day 1: PF-07321332 300 mg + Ritonavir 100 mg|||43.156|10.097|0.2810
71004385|NCT04960202|141516897|SUPERIORITY||Odds Ratio (OR)|12.452|||||TWO_SIDED|95.0|6.823|22.725|||Breslow Day test||Odds ratio for Day 5 vs Day 1: Placebo|||22.725|6.823|
71004386|NCT04960202|141516898|SUPERIORITY||Odds Ratio (OR)|21.119||||0.2226|TWO_SIDED|95.0|10.412|42.837|||Breslow-Day test||Odds ratio for Day 5 vs Day 1: PF-07321332 300 mg + Ritonavir 100 mg|||42.837|10.412|0.2226
71004387|NCT04960202|141516898|SUPERIORITY||Odds Ratio (OR)|12.036||||0.2342|TWO_SIDED|95.0|6.808|21.28|||Breslow-Day test||Odds ratio for Day 5 vs Day 1: Placebo|||21.280|6.808|0.2342
71004388|NCT03558828|141516928|OTHER|A power analysis based on the study's primary aim (impact of augmented treatments on non-responders) was conducted. An estimated effect size of d=0.41 for the difference between the two augmented treatments was used. With a 2-tailed alpha of 0.05, a pre-post correlation of r=0.60, and a sample size of 188 non-responders, an estimated 80% power was obtained. Assuming 67% non-response to the initial treatments and 10% attrition, the final target sample size was N=312.|Effect size estimates|0.41|||||TWO_SIDED|95.0||||All analyses employed an intent-to-treat approach using a two-tailed alpha of 0.05 with no adjustment for multiple tests.|GEEs||Effect size estimates (Cohen's d) for all analyses were created by using the relevant slope (i.e., change) effect as the numerator and the baseline standard deviation of the dependent variable as the denominator.||"The longitudinal trajectories using generalized estimating equations (GEEs) were estimated. Cases for responders are duplicated and weighted based on the inverse probability of being assigned to a particular adaptive intervention (i.e., responders have a ½ probability of assignment to a specific adaptive intervention, and non-responders have a ¼ probability).~Only the Phase 1 (baseline to 8 weeks) treatment condition x time interaction was included because it preceded the randomization to Phase 2 (weeks 9-34) treatment conditions. Planned contrasts were used to test specific hypotheses. Effect size estimates for all analyses were created by using the relevant slope effect as the numerator and the baseline standard deviation of the dependent variable as the denominator. All analyses employed an intent-to-treat approach using a two-tailed alpha of 0.05 with no adjustment for multiple tests."|||
71004389|NCT03558828|141516929|OTHER|A power analysis based on the study's primary aim (impact of augmented treatments on non-responders) was conducted. An estimated effect size of d=0.41 for the difference between the two augmented treatments was used. With a 2-tailed alpha of 0.05, a pre-post correlation of r=0.60, and a sample size of 188 non-responders, an estimated 80% power was obtained. Assuming 67% non-response to the initial treatments and 10% attrition, the final target sample size was N=312.|Effect size estimates|0.41|||||TWO_SIDED|95.0||||All analyses employed an intent-to-treat approach using a two-tailed alpha of 0.05 with no adjustment for multiple tests.|GEEs||Effect size estimates for all analyses were created by using the relevant slope (i.e., change) effect as the numerator and the baseline standard deviation of the dependent variable as the denominator. An estimated effect size of d=0.41 was used.||There were time slope terms for Phase 1 (baseline to 8-week assessment), Phase 2 (9-weeks to 34-week assessment), and Phase 3 (maintenance from 35-weeks to 50-week assessment). Also, there were interactions of condition and time slopes. For Phase 1, only the Phase 1 treatment condition x time interaction was included because it preceded the randomization to Phase 2 treatment conditions. Supplementary analyses were conducted to compare the trajectories of responders versus non-responders to the Phase 1 treatment. Effect size estimates for all analyses were created by using the relevant slope (i.e., change) effect as the numerator and the baseline standard deviation of the dependent variable as the denominator. The resulting effect size is equivalent to a Cohen's d, representing mean change (or difference in change) in standard deviation units. All analyses employed an intent-to-treat approach using a two-tailed alpha of 0.05 with no adjustment for multiple tests.|||
71043926|NCT01730040|141597420|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.1|||<|0.0001|TWO_SIDED|99.0|-32.9|-13.2||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-13.2|-32.9|<0.0001
71043927|NCT01730040|141597420|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.8|||<|0.0001|TWO_SIDED|99.0|-25.8|-5.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-5.8|-25.8|<0.0001
70924692|NCT04321031|141342046|SUPERIORITY||Risk Difference (RD)|0.04|||||TWO_SIDED|90.0|-0.02|0.33||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.33|-0.02|
71004390|NCT03671148|141516964|SUPERIORITY||Response Rate Difference|24.5|||<|0.001|TWO_SIDED|95.0|15.9|33.0||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|The comparison between the risankizumab and placebo treatment groups for the primary efficacy endpoint (ACR20 at Week 24) was performed using the Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factors of current use of csDMARD (0 vs ≥ 1), number of prior biologic therapies (0 vs ≥ 1), and extent of psoriasis (≥ 3% BSA or \< 3% BSA) at Baseline.||33.0|15.9|<0.001
71004391|NCT03671148|141516965|SUPERIORITY||Least Squares (LS) Mean Difference|-0.16|||<|0.001|TWO_SIDED|95.0|-0.26|-0.07||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||-0.07|-0.26|<0.001
71004392|NCT03671148|141516966|SUPERIORITY||Response Rate Difference|44.3|||<|0.001|TWO_SIDED|95.0|33.9|54.6||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||54.6|33.9|<0.001
71004393|NCT03671148|141516967|SUPERIORITY||Response Rate Difference|22.6|||<|0.001|TWO_SIDED|95.0|13.9|31.2||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||31.2|13.9|<0.001
71004394|NCT03671148|141516968|SUPERIORITY||Response Rate Difference|14.0|||<|0.001|TWO_SIDED|95.0|7.0|21.0||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||21.0|7.0|<0.001
71004395|NCT03671148|141516969|SUPERIORITY||LS Mean Difference|3.86|||<|0.001|TWO_SIDED|95.0|2.41|5.31||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||5.31|2.41|<0.001
71004396|NCT03671148|141516970|SUPERIORITY||LS Mean Difference|2.2||||0.009|TWO_SIDED|95.0|0.6|3.9||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||3.9|0.6|0.009
71004397|NCT03671148|141516971|SUPERIORITY||Response Rate Difference|16.6|||<|0.001|TWO_SIDED|95.0|9.7|23.6|||Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||23.6|9.7|<0.001
71043928|NCT01730040|141597420|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.9|||<|0.0001|TWO_SIDED|99.0|-39.4|-18.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-18.4|-39.4|<0.0001
71101289|NCT00456365|141710725|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANCOVA|||||||0.02
71004398|NCT03671148|141516972|SUPERIORITY||Response Rate Difference|6.0||||0.024|TWO_SIDED|95.0|0.8|11.3|||Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||11.3|0.8|0.024
71101290|NCT00456365|141710726|SUPERIORITY_OR_OTHER|||||||0.69|||||||ANOVA|||||||0.69
71101291|NCT00456365|141710727|SUPERIORITY_OR_OTHER|||||||0.21|||||||ANCOVA|||||||0.21
71101292|NCT02202577|141710730|SUPERIORITY||Risk Ratio (RR)|0.9||||0.38|ONE_SIDED|95.0||1.35||This is the calculated p-value for the intention to treat analysis of primary outcome. A 1-tailed p value of \<0.05 was selected for statistical significance.|Fisher Exact|||"We estimated a cesarean related surgical site infection rate of 7.5% with povidone-iodine and hypothesized chlorhexidine-alcohol treatment to be superior based on existing literature. We considered a 50% reduction to be significant. We performed our power analysis assuming~1-directional effects in favor of chlorhexidine, which best fit our hypothesis. Using a 1-tailed alpha of 0.05 and an 80% power to detect a difference, we estimated that 466 subjects would be required in each group."||1.35||0.38
71101293|NCT02202577|141710730|SUPERIORITY||Risk Ratio (RR)|0.83||||0.26|ONE_SIDED|95.0||1.25||This is the calculated p-value for the per protocol analysis of primary outcome. A 1-tailed p value of \<0.05 was selected for statistical significance.|Fisher Exact|||Per Protocol Analysis||1.25||0.26
71043929|NCT01730040|141597420|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.9|||<|0.0001|TWO_SIDED|99.0|-32.4|-11.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-11.4|-32.4|<0.0001
71101294|NCT02034565|141710735|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.977|||||TWO_SIDED|90.0|0.756|1.261||||||||1.261|0.756|
71101295|NCT02034565|141710736|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|1.05|||||TWO_SIDED|90.0|0.938|1.176||||||||1.176|0.938|
71004399|NCT03671148|141516973|SUPERIORITY||Response Rate Difference|13.8||||0.009|TWO_SIDED|95.0|3.5|24.2|||Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||24.2|3.5|0.009
71004400|NCT03671148|141516974|SUPERIORITY||Response Rate Difference|38.8|||<|0.001|TWO_SIDED|95.0|22.9|54.8|||Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||54.8|22.9|<0.001
71043930|NCT01730040|141597420|SUPERIORITY_OR_OTHER||LS Mean Difference|-18.4|||<|0.0001|TWO_SIDED|99.0|-29.1|-7.7||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-7.7|-29.1|<0.0001
71043931|NCT01730040|141597421|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.5|||<|0.0001|TWO_SIDED|99.0|-41.6|-21.3||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-21.3|-41.6|<0.0001
71043932|NCT01730040|141597421|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.3|||<|0.0001|TWO_SIDED|99.0|-35.4|-15.2||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.2|-35.4|<0.0001
71043933|NCT01730040|141597421|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.7|||<|0.0001|TWO_SIDED|99.0|-35.9|-17.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-17.5|-35.9|<0.0001
71043934|NCT01730040|141597421|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.2|||<|0.0001|TWO_SIDED|99.0|-31.5|-12.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-12.9|-31.5|<0.0001
71043935|NCT01730040|141597421|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.9|||<|0.0001|TWO_SIDED|99.0|-25.2|-6.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-6.6|-25.2|<0.0001
71043936|NCT01730040|141597422|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.5|||<|0.0001|TWO_SIDED|99.0|-45.3|-21.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-21.6|-45.3|<0.0001
71043937|NCT01730040|141597422|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.4|||<|0.0001|TWO_SIDED|99.0|-35.2|-11.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-11.6|-35.2|<0.0001
71101296|NCT02034565|141710737|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|1.043|||||TWO_SIDED|90.0|0.933|1.167||||||||1.167|0.933|
71101297|NCT00829868|141710748|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|109.0||||||90.0|99.3|120.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||120|99.3|
71101298|NCT00829868|141710749|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|101.0||||||90.0|97.5|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106|97.5|
71101299|NCT00829868|141710750|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|100.0||||||90.0|96.2|104.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104|96.2|
71101300|NCT00967486|141710761|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
71101301|NCT00803049|141710771|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.824||||0.2079|TWO_SIDED|95.0|0.602|1.128||Threshold for significance at 0.05 level.|Log Rank||Placebo/Teriflunomide 7 mg vs. Teriflunomide 7 mg/7 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.||1.128|0.602|0.2079
71043938|NCT01730040|141597422|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.3|||<|0.0001|TWO_SIDED|99.0|-39.0|-19.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-19.6|-39.0|<0.0001
71101302|NCT00803049|141710771|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.825||||0.3039|TWO_SIDED|95.0|0.591|1.152||Threshold for significance at 0.05 level.|Log Rank||Placebo/Teriflunomide 14 mg vs.Teriflunomide 14 mg/14 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.||1.152|0.591|0.3039
71101303|NCT00803049|141710771|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.963||||0.8271|TWO_SIDED|95.0|0.736|1.26||Threshold for significance at 0.05 level.|Log Rank||Teriflunomide 7 mg/7 mg vs. Teriflunomide 14 mg/14 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.||1.260|0.736|0.8271
71101304|NCT00803049|141710772|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.961||||0.8017|TWO_SIDED|95.0|0.678|1.362||Threshold for significance at 0.05 level.|Log Rank||Placebo/Teriflunomide 7 mg vs. Teriflunomide 7 mg/7 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.||1.362|0.678|0.8017
71043939|NCT01730040|141597422|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.5|||<|0.0001|TWO_SIDED|99.0|-32.3|-12.7||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-12.7|-32.3|<0.0001
71043940|NCT01730040|141597422|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.8|||<|0.0001|TWO_SIDED|99.0|-24.7|-4.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-4.9|-24.7|<0.0001
71004401|NCT04423718|141516975|NON_INFERIORITY|One-sided test (alpha=0.025) for non-inferiority at a 4-letter margin|Difference in LS means|-0.97||||0.0009|TWO_SIDED|95.0|-2.87|0.92||Strictly hierarchical testing procedure: Since p-value below significance level 0.025, fixed sequence testing continued with next primary endpoint (HDq16-2q8) / within EMA/PMDA specific hierarchy with secondary endpoint (BCVA at W60, HDq12-2q8)|Mixed Models Analysis|Adjusted for baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq12 - 2q8||0.92|-2.87|0.0009
71043941|NCT01730040|141597423|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.6|||<|0.0001|TWO_SIDED|99.0|-31.4|-13.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-13.8|-31.4|<0.0001
71043942|NCT01730040|141597423|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.8|||<|0.0001|TWO_SIDED|99.0|-24.6|-7.0||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-7.0|-24.6|<0.0001
71043943|NCT01730040|141597423|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.1|||<|0.0001|TWO_SIDED|99.0|-26.9|-11.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-11.4|-26.9|<0.0001
71004402|NCT04423718|141516975|NON_INFERIORITY|One-sided test (alpha=0.025) for non-inferiority at a 4-letter margin|Difference in LS means|-1.14||||0.0011|TWO_SIDED|95.0|-2.97|0.69||Strictly hierarchical testing procedure: Since p-value below significance level 0.025, fixed sequence testing continued with secondary endpoint (no IRF no SRF at W16)/within EMA/PMDA specific hierarchy with secondary endpoint (BCVA at W60, HDq16-2q8)|Mixed Models Analysis|Adjusted for baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq16 - 2q8||0.69|-2.97|0.0011
71004403|NCT04423718|141516976|NON_INFERIORITY|One-sided test (alpha=0.025) for non-inferiority at a 4-letter margin|Difference in LS means|-0.86||||0.0002|TWO_SIDED|95.0|-2.57|0.84||EMA/PMDA specific hierarchy: i.e. secondary endpoint was tested for EMA/PMDA after primary endpoint (HDq12-2q8). Since p-value below significance level 0.025, EMA/PMDA specific fixed sequence testing continued with next primary endpoint (HDq16-2q8)|Mixed Models Analysis|Adjusted for baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq12 - 2q8||0.84|-2.57|0.0002
71004404|NCT04423718|141516976|NON_INFERIORITY|One-sided test (alpha=0.025) for non-inferiority at a 4-letter margin|Difference in LS means|-0.92|||<|0.0001|TWO_SIDED|95.0|-2.51|0.66||EMA/PMDA specific hierarchy: i.e. secondary endpoint was tested after primary endpoint (HDq16-2q8). Since p-value below significance level 0.025, EMA/PMDA specific fixed sequence testing continued with secondary endpoint test (no IRF no SRF at W16)|Mixed Models Analysis|Adjusted for baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq16 - 2q8||0.66|-2.51|<0.0001
71043944|NCT01730040|141597423|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.4|||<|0.0001|TWO_SIDED|99.0|-23.3|-7.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-7.6|-23.3|<0.0001
71043945|NCT01730040|141597423|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.8|||=|0.0015|TWO_SIDED|99.0|-17.7|-1.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-1.9|-17.7|=0.0015
71043946|NCT01730040|141597424|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.7|||<|0.0001|TWO_SIDED|99.0|3.9|71.7||Threshold for significance ≤ 0.01.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||71.7|3.9|<0.0001
71101305|NCT00803049|141710772|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.1866|TWO_SIDED|95.0|0.559|1.117||Threshold for significance at 0.05 level.|Log Rank||Placebo/Teriflunomide 14 mg vs. Teriflunomide 14 mg/14 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.||1.117|0.559|0.1866
71101306|NCT00803049|141710772|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.8763|TWO_SIDED|95.0|0.767|1.357||Threshold for significance at 0.05 level.|Log Rank||Teriflunomide 7 mg/7 mg vs. Teriflunomide 14 mg/14 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.||1.357|0.767|0.8763
71043947|NCT01730040|141597424|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.4|||=|0.0284|TWO_SIDED|99.0|0.8|14.6||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||14.6|0.8|=0.0284
71043948|NCT01730040|141597424|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|83.2|||<|0.0001|TWO_SIDED|99.0|11.6|596.8||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||596.8|11.6|<0.0001
71043949|NCT01730040|141597424|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.2|||=|0.0025|TWO_SIDED|99.0|1.3|38.3||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||38.3|1.3|=0.0025
71043950|NCT01730040|141597424|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.1|||=|0.0011|TWO_SIDED|99.0|1.6|52.2||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||52.2|1.6|=0.0011
71043951|NCT01730040|141597425|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|128.4|||<|0.0001|TWO_SIDED|99.0|14.2|1157.0||Threshold for significance ≤ 0.01.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||1157|14.2|<0.0001
71004405|NCT04423718|141516977|SUPERIORITY|One sided test (alpha = 0.025) for superiority|Difference|11.733||||0.0002|TWO_SIDED|95.0|5.263|18.204||Strictly hierarchical testing procedure to adjust for multiplicity.|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|All HD - 2q8||18.204|5.263|0.0002
71101307|NCT01421459|141710776|NON_INFERIORITY_OR_EQUIVALENCE|The primary treatment comparison was to compare LY2963016 versus Lantus at the non-inferiority margin of +0.4%. If the upper limit of the 95% confidence interval on the change from baseline to 24-week endpoint HbA1c for LY2963016 versus Lantus was below +0.4%, then LY2963016 would be declared non-inferior to Lantus.|Mean Difference (Final Values)|0.052||||0.403|TWO_SIDED|95.0|-0.07|0.175|||ANCOVA|||||0.175|-0.070|0.403
71101308|NCT01421459|141710778|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||P-value is for 4 weeks.|ANCOVA|||||||0.382
70924693|NCT04321031|141342046|SUPERIORITY||Risk Difference (RD)|0.17|||||TWO_SIDED|90.0|0.01|0.58||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.58|0.01|
71004406|NCT04423718|141516978|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference|-1.748||||0.5704|TWO_SIDED|95.0|-7.784|4.287||Nominal p-value, not adjusted for multiplicity|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|HDq12 - 2q8||4.287|-7.784|0.5704
71004407|NCT04423718|141516978|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference|-0.939||||0.7611|TWO_SIDED|95.0|-6.997|5.119||Nominal p-value, not adjusted for multiplicity|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|HDq16 - 2q8||5.119|-6.997|0.7611
71004408|NCT04423718|141516979|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference|-0.182||||0.9554|TWO_SIDED|95.0|-6.565|6.2||Nominal p-value, not adjusted for multiplicity|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|HDq12 - 2q8||6.200|-6.565|0.9554
71004409|NCT04423718|141516979|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference|-2.221||||0.4834|TWO_SIDED|95.0|-8.435|3.994||Nominal p-value, not adjusted for multiplicity|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|HDq16 - 2q8||3.994|-8.435|0.4834
71004410|NCT04423718|141516980|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-1.22||||0.0009|TWO_SIDED|95.0|-1.94|-0.51||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline CNV size and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq12 - 2q8||-0.51|-1.94|0.0009
71004411|NCT04423718|141516980|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-0.48||||0.2076|TWO_SIDED|95.0|-1.22|0.27||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline CNV size and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq16 - 2q8||0.27|-1.22|0.2076
71004412|NCT04423718|141516981|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-0.55||||0.0287|TWO_SIDED|95.0|-1.04|-0.06||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline total lesion area and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq12 - 2q8||-0.06|-1.04|0.0287
71004413|NCT04423718|141516981|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-0.44||||0.087|TWO_SIDED|95.0|-0.94|0.06||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline total lesion area and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq16 - 2q8||0.06|-0.94|0.0870
71004414|NCT04423718|141516982|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference|11.725||||0.0015|TWO_SIDED|95.0|4.527|18.923||Nominal p-value, not adjusted for multiplicity|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|HDq12 - 2q8||18.923|4.527|0.0015
71004415|NCT04423718|141516982|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference|7.451||||0.0458|TWO_SIDED|95.0|0.142|14.76||Nominal p-value, not adjusted for multiplicity|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|HDq16 - 2q8||14.760|0.142|0.0458
71004416|NCT04423718|141516983|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-11.12||||0.0283|TWO_SIDED|95.0|-21.06|-1.18||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline CST and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq12 - 2q8||-1.18|-21.06|0.0283
71101309|NCT01421459|141710778|SUPERIORITY_OR_OTHER|||||||0.91||95.0||||P-value is for 8 weeks.|ANCOVA|||||||0.910
71043952|NCT01730040|141597425|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.9|||=|0.0015|TWO_SIDED|99.0|1.6|75.4||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||75.4|1.6|=0.0015
71043953|NCT01730040|141597425|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.7|||=|0.0008|TWO_SIDED|99.0|1.8|101.1||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||101.1|1.8|=0.0008
71043954|NCT01730040|141597426|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|116.8|||<|0.0001|TWO_SIDED|99.0|14.7|927.5||Threshold for significance ≤ 0.01.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||927.5|14.7|<0.0001
71043955|NCT01730040|141597426|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.2|||<|0.0001|TWO_SIDED|99.0|2.5|68.8||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||68.8|2.5|<0.0001
71004417|NCT04423718|141516983|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-10.51||||0.0321|TWO_SIDED|95.0|-20.12|-0.9||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline CST and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq16 - 2q8||-0.90|-20.12|0.0321
71004418|NCT04423718|141516984|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-0.72||||0.3817|TWO_SIDED|95.0|-2.35|0.9||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline NEI-VFQ-25 total score and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq12 - 2q8||0.90|-2.35|0.3817
71004419|NCT04423718|141516984|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-0.87||||0.307|TWO_SIDED|95.0|-2.55|0.8||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline NEI-VFQ-25 total score and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq16 - 2q8||0.80|-2.55|0.3070
71004420|NCT00425945|141516988|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.3|||||TWO_SIDED|95.0|-0.1|14.9||||||||14.9|-0.1|
71043956|NCT01730040|141597426|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.9|||=|0.0004|TWO_SIDED|99.0|1.9|51.9||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||51.9|1.9|=0.0004
71043957|NCT01730040|141597427|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|162.1|||<|0.0001|TWO_SIDED|99.0|17.3|1520.5||Threshold for significance ≤ 0.01.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||1520.5|17.3|<0.0001
71043958|NCT01730040|141597427|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|19.8|||<|0.0001|TWO_SIDED|99.0|3.1|126.3||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||126.3|3.1|<0.0001
71043959|NCT01730040|141597427|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.9|||=|0.0002|TWO_SIDED|99.0|2.2|88.1||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||88.1|2.2|=0.0002
71101310|NCT01421459|141710778|SUPERIORITY_OR_OTHER|||||||0.869||95.0||||P-value is for 12 weeks.|ANCOVA|||||||0.869
71101311|NCT01421459|141710778|SUPERIORITY_OR_OTHER|||||||0.345||95.0||||P-value is for 16 weeks.|ANCOVA|||||||0.345
71043960|NCT01730040|141597428|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-21.1|||=|0.0004|TWO_SIDED|99.0|-36.3|-5.9||Threshold for significance ≤ 0.01.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-5.9|-36.3|=0.0004
71043961|NCT01730040|141597428|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-25.9|||<|0.0001|TWO_SIDED|99.0|-40.2|-11.6||Threshold for significance ≤ 0.01.|Regression, Robust|||Analysis description as per the statistical analysis 1 of this endpoint.||-11.6|-40.2|<0.0001
71043962|NCT01730040|141597428|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-31.0|||<|0.0001|TWO_SIDED|99.0|-45.6|-16.4||Threshold for significance ≤ 0.01.|Regression, Robust|||Analysis description as per the statistical analysis 1 of this endpoint.||-16.4|-45.6|<0.0001
70924694|NCT04321031|141342046|SUPERIORITY||Risk Difference (RD)|0.08|||||TWO_SIDED|50.0|0.02|0.16||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.16|0.02|
71004421|NCT00425945|141516989|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.4|||||TWO_SIDED|95.0|-2.1|10.8||||||||10.8|-2.1|
71004422|NCT00425945|141516990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-1.7|2.5||||||||2.5|-1.7|
71043963|NCT01730040|141597429|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|||=|0.4456|TWO_SIDED|99.0|-7.0|12.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification).||12.9|-7.0|=0.4456
71101312|NCT01421459|141710778|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-value is for 20 weeks.|ANCOVA|||||||0.161
71101313|NCT01421459|141710778|SUPERIORITY_OR_OTHER|||||||0.097||95.0||||P-value is for 24 weeks.|ANCOVA|||||||0.097
71101314|NCT01421459|141710779|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||P-value is at Morning Pre-Meal at Baseline.|ANCOVA|||||||0.837
71101315|NCT01421459|141710779|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||P-value is for Morning 2 hrs PP Meal at Baseline.|ANCOVA|||||||0.620
71101316|NCT01421459|141710779|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||P-value is for Midday Pre-Meal at Baseline|ANCOVA|||||||0.107
71101317|NCT01421459|141710779|SUPERIORITY_OR_OTHER|||||||0.258||95.0||||P-value is for Midday 2 hrs PP Meal at Baseline.|ANCOVA|||||||0.258
71101318|NCT01421459|141710779|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-value is for Evening Pre-Meal at Baseline.|ANCOVA|||||||0.161
71043964|NCT01546142|141597442|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.983|||<|0.001|TWO_SIDED|95.0|2.311|3.849|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) method stratified by pooled study center.|A risk ratio greater than 1 favors deoxycholic acid injection treatment, and between 0 and 1 favors placebo.|The primary analysis was satisfied if both null hypotheses (that there is no treatment difference in 1-grade or 2-grade response rate) were rejected in favor of the two-tailed alternative at the 0.05 level of significance for both primary efficacy endpoints, and the response rates were higher for the deoxycholic acid injection treatment group than the placebo group. Because both hypotheses must be rejected, the type I error was preserved when testing the primary endpoints.||3.849|2.311|<0.001
71101319|NCT01421459|141710779|SUPERIORITY_OR_OTHER|||||||0.725||95.0||||P-value is for Bed Time at Baseline.|ANCOVA|||||||0.725
71101320|NCT01421459|141710779|SUPERIORITY_OR_OTHER|||||||0.543||95.0||||P-value is for 0300 hrs at Baseline.|ANCOVA|||||||0.543
71101321|NCT01421459|141710779|SUPERIORITY_OR_OTHER|||||||0.265||95.0||||P-value is for Morning Pre-Meal at Endpoint, up to 24 wk.|ANCOVA|||||||0.265
71101322|NCT01421459|141710779|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value is for Morning 2 hrs PP Meal at Endpoint, up to 24 weeks.|ANCOVA|||||||0.050
71101323|NCT01421459|141710779|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||P-value is for Midday Pre-Meal at Endpoint, up to 24 weeks.|ANCOVA|||||||0.040
71101324|NCT01421459|141710779|SUPERIORITY_OR_OTHER|||||||0.366||95.0||||P-value is for Midday 2 hrs PP Meal at Endpoint, up to 24 weeks.|ANCOVA|||||||0.366
71101325|NCT01421459|141710779|SUPERIORITY_OR_OTHER|||||||0.485||95.0||||P-value is for Evening Pre-Meal at Endpoint, up to 24 weeks.|ANCOVA|||||||0.485
71004423|NCT00425945|141516991|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.2|||||TWO_SIDED|95.0|-2.3|38.7||||||||38.7|-2.3|
71004424|NCT00425945|141516992|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.1|0.3||||||||0.3|-0.1|
71004425|NCT00425945|141516993|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|0.0|0.1||||||||0.1|-0.0|
71004426|NCT00425945|141516994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2|||||TWO_SIDED|95.0|-6.8|0.5||||||||0.5|-6.8|
71004427|NCT00425945|141516995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-1.5|0.5||||||||0.5|-1.5|
71004428|NCT00425945|141516996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|0.0|0.4||||||||0.4|0.0|
71004429|NCT00425945|141516997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2|||||TWO_SIDED|95.0|0.1|2.4||||||||2.4|0.1|
71004430|NCT00425945|141516998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|||||TWO_SIDED|95.0|-4.4|2.3||||||||2.3|-4.4|
71004431|NCT00425945|141516999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|||||TWO_SIDED|95.0|-0.9|2.5||||||||2.5|-0.9|
71004432|NCT00425945|141517000|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||||0.1|-0.1|
71004433|NCT00425945|141517001|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.8|||||TWO_SIDED|95.0|-1.6|9.3||||||||9.3|-1.6|
71004434|NCT00425945|141517002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3|||||TWO_SIDED|95.0|-3.4|0.8||||||||0.8|-3.4|
71004435|NCT05032755|141517017|SUPERIORITY||beta estimate|1.902|STANDARD_ERROR_OF_MEAN|0.398|<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term|||||<.0001
71004436|NCT05032755|141517018|SUPERIORITY||beta estimate|0.368|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 5 levels. Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||<.0001
71004437|NCT05032755|141517019|SUPERIORITY||beta estimate|0.672|STANDARD_ERROR_OF_MEAN|0.362||0.065|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 5 levels. Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.065
71004438|NCT05032755|141517020|SUPERIORITY||beta estimate|0.364|STANDARD_ERROR_OF_MEAN|0.133||0.007|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 5 levels. Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.007
71004439|NCT05032755|141517021|SUPERIORITY||beta estimate|1.78|STANDARD_ERROR_OF_MEAN|1.78||0.325|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 2 levels (pre- vs post-intervention). Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.325
71004440|NCT05032755|141517023|SUPERIORITY||beta estimate|0.222|STANDARD_ERROR_OF_MEAN|0.104||0.035|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 5 levels. Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.035
71004441|NCT05032755|141517024|SUPERIORITY||beta estimate|0.201|STANDARD_ERROR_OF_MEAN|0.181||0.27|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 5 levels. Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.27
71004442|NCT05032755|141517025|SUPERIORITY||beta estimate|-1.229|STANDARD_ERROR_OF_MEAN|1.037||0.24|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 5 levels. Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.24
71004443|NCT05032755|141517030|SUPERIORITY||beta estimate|4.69|STANDARD_ERROR_OF_MEAN|2.88||0.113|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 2 levels (pre- vs post-intervention). Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.113
71043965|NCT01546142|141597443|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|6.271|||<|0.001|TWO_SIDED|95.0|2.908|13.52|||Cochran-Mantel-Haenszel|CMH method stratified by pooled study center.|A risk ratio greater than 1 favors deoxycholic acid injection treatment, and between 0 and 1 favors placebo.|The primary analysis was satisfied if both null hypotheses (that there is no treatment difference in 1-grade or 2-grade response rate) were rejected in favor of the two-tailed alternative at the 0.05 level of significance for both primary efficacy endpoints, and the response rates were higher for the deoxycholic acid injection treatment group than the placebo group. Because both hypotheses must be rejected, the type I error was preserved when testing the primary endpoints.||13.520|2.908|<0.001
71043966|NCT01546142|141597444|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|7.838|||<|0.001|TWO_SIDED|95.0|3.299|18.622|||Cochran-Mantel-Haenszel|CMH method stratified by pooled study center|A risk ratio greater than 1 favors deoxycholic acid injection treatment, and between 0 and 1 favors placebo.|If both primary endpoints were statistically significant, testing continued to the 2 secondary endpoints using the Bonferroni-Holm method. The smaller of the 2 p-values for the treatment difference was tested at the 0.025 level. If significant, testing proceeded for the remaining secondary endpoint at the 0.05 level. If the smaller p-value was \> 0.025, the null hypothesis for the associated variable would not be rejected, and testing of the second endpoint would not proceed.||18.622|3.299|<0.001
71043967|NCT01546142|141597445|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|Analysis of covariance (ANCOVA) model included treatment and Baseline PR-SMFIS total scale score.||If both primary endpoints were statistically significant, testing continued to the 2 secondary endpoints using the Bonferroni-Holm method. The smaller of the 2 p-values for the treatment difference was tested at the 0.025 level. If significant, testing proceeded for the remaining secondary endpoint at the 0.05 level. If the smaller p-value was \> 0.025, the null hypothesis for the associated variable would not be rejected, and testing of the second endpoint would not proceed.||||<0.001
71043968|NCT00255151|141597456|SUPERIORITY_OR_OTHER||||||<|1e-05||||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact|||||||<0.00001
71101326|NCT01421459|141710779|SUPERIORITY_OR_OTHER|||||||0.537||95.0||||P-value is for Bed Time at Endpoint, up to 24 weeks.|ANCOVA|||||||0.537
71101327|NCT01421459|141710779|SUPERIORITY_OR_OTHER|||||||0.878||95.0||||P-value is for 0300 hrs at Endpoint, up to 24 weeks.|ANCOVA|||||||0.878
71101328|NCT01421459|141710780|SUPERIORITY_OR_OTHER|||||||0.779||95.0||||P-value is for Baseline.|ANCOVA|||||||0.779
71043969|NCT00255151|141597456|SUPERIORITY_OR_OTHER||||||<|1e-05||||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact|||||||<0.00001
71043970|NCT00255151|141597456|SUPERIORITY_OR_OTHER|||||||0.80473||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.80473
71043971|NCT00255151|141597457|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
71043972|NCT00255151|141597457|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
71101329|NCT01421459|141710780|SUPERIORITY_OR_OTHER|||||||0.788||95.0||||P-value is for Endpoint, up to 24 weeks.|ANCOVA|||||||0.788
71101330|NCT01421459|141710781|SUPERIORITY_OR_OTHER|||||||0.687||95.0||||P-value is for Baseline.|ANCOVA|||||||0.687
71101331|NCT01421459|141710781|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||P-value is for change at 4 wks.|ANCOVA|||||||0.036
71101332|NCT01421459|141710781|SUPERIORITY_OR_OTHER|||||||0.323||95.0||||P-value is for change at 8 wks.|ANCOVA|||||||0.323
71101333|NCT01421459|141710781|SUPERIORITY_OR_OTHER|||||||0.368||95.0||||P-value is for change at 12 wks.|ANCOVA|||||||0.368
71101334|NCT01421459|141710781|SUPERIORITY_OR_OTHER|||||||0.089||95.0||||P-value is for change at 16 wks.|ANCOVA|||||||0.089
71101335|NCT01421459|141710781|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||P-value is for change at 20 wks.|ANCOVA|||||||0.041
71101336|NCT01421459|141710781|SUPERIORITY_OR_OTHER|||||||0.33||95.0||||P-value is for change at 24 wks.|ANCOVA|||||||0.330
71101337|NCT01421459|141710781|SUPERIORITY_OR_OTHER|||||||0.334||95.0||||P-value is for change at Endpoint, up to 24 wks.|ANCOVA|||||||0.334
71101338|NCT01421459|141710782|SUPERIORITY_OR_OTHER|||||||0.726||95.0||||P-value is for Behavior domain at 4 weeks.|ANCOVA|||||||0.726
71101339|NCT01421459|141710782|SUPERIORITY_OR_OTHER|||||||0.502||95.0||||P-value is for Behavior domain at 12 weeks.|ANCOVA|||||||0.502
71101340|NCT01421459|141710782|SUPERIORITY_OR_OTHER|||||||0.437||95.0||||P-value is for Behavior domain at Endpoint, up to 24 weeks.|ANCOVA|||||||0.437
71101341|NCT01421459|141710782|SUPERIORITY_OR_OTHER|||||||0.237||95.0||||P-value is for Worry domain at 4 weeks.|ANCOVA|||||||0.237
71004444|NCT05618808|141517031|SUPERIORITY||Posterior Odds Ratio|0.78|||||TWO_SIDED|90.0|0.47|1.32|||||REGN9933 vs Enoxaparin||"Bayesian Logistic Regression; Confidence Interval refers to Credible Interval"|1.32|0.47|
71004445|NCT05618808|141517034|SUPERIORITY||Posterior Odds Ratio|0.44|||||TWO_SIDED|90.0|0.16|1.61|||||REGN9933 vs Enoxaparin||"Bayesian Logistic Regression; Confidence Interval refers to Credible Interval"|1.61|0.16|
71004446|NCT05618808|141517035|SUPERIORITY||Posterior Odds Ratio|0.79|||||TWO_SIDED|90.0|0.47|1.32|||||REGN9933 vs Enoxaparin||"Bayesian Logistic Regression; Confidence Interval refers to Credible Interval"|1.32|0.47|
71004447|NCT05618808|141517041|SUPERIORITY||Posterior Odds Ratio|0.54|||||TWO_SIDED|90.0|0.32|0.95|||||Enoxaparin vs Apixaban||"Bayesian Logistic Regression; Confidence Interval refers to Credible Interval"|0.95|0.32|
71004448|NCT01874353|141517052|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.22|0.41||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.41|0.22|<0.0001
71004449|NCT01874353|141517052|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.17|1.19||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes a treatment factor only|A hazard ratio \< 1 favours olaparib|||1.19|0.17|
71004450|NCT01874353|141517053|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.0537|TWO_SIDED|95.0|0.54|1.0||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \<1 favours olaparib|||1.00|0.54|0.0537
71004451|NCT01874353|141517053|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.38|2.49||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes a treatment factor only|A hazard ratio \<1 favours olaparib|||2.49|0.38|
71004452|NCT01874353|141517054|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.23|0.41||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.41|0.23|<0.0001
71004453|NCT01874353|141517054|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.41|||||TWO_SIDED|95.0|0.18|1.03||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes a treatment factor only|A hazard ratio \<1 favours olaparib|||1.03|0.18|
71004454|NCT01874353|141517055|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.5||||0.0002|TWO_SIDED|95.0|0.34|0.72||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.72|0.34|0.0002
71004455|NCT01874353|141517055|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.22|3.97||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes treatment factor only|A hazard ratio \< 1 favours olaparib|||3.97|0.22|
71004456|NCT01874353|141517056|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03||||0.9765|TWO_SIDED|95.0|-2.191|2.126|||Mixed Models Analysis|Fixed effects for treatment, visit and baseline TOI with the treatment by visit and baseline TOI by visit interaction. Random patient effect.||||2.126|-2.191|0.9765
71004457|NCT01874353|141517057|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.28|0.48||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.48|0.28|<0.0001
71004458|NCT01874353|141517057|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.21|1.08||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes a treatment factor only|A hazard ratio \< 1 favours olaparib|||1.08|0.21|
71043973|NCT00255151|141597457|SUPERIORITY_OR_OTHER|||||||0.76046||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.76046
71004459|NCT01874353|141517058|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.39|0.68||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.68|0.39|<0.0001
71004460|NCT01874353|141517058|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.37|1.85||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model included treatment factor only|A hazard ratio \< 1 favours olaparib|||1.85|0.37|
71004461|NCT01874353|141517059|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.28|0.49||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.49|0.28|<0.0001
71004462|NCT01874353|141517059|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.2|1.04||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes a treatment factor only|A hazard ratio \< 1 favours the Olaparib arm|||1.04|0.20|
71004463|NCT01874353|141517060|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.22|0.4||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.40|0.22|<0.0001
71004464|NCT03774875|141517070|SUPERIORITY||Adjusted Difference in Response Rates|31.9|STANDARD_ERROR_OF_MEAN|6.78|<|0.0001|TWO_SIDED|95.0|18.6|45.2|||Cochran-Mantel-Haenszel|The CMH (Cochran-Mantel-Haenszel) test adjusting for the stratification of the 5 difficult to treat manifestation types at randomization.|Adjusted difference (apremilast - placebo) in response rates calculated using the weighted average of the treatment differences across the strata with the CMH weights.|||45.2|18.6|<0.0001
71043974|NCT00255151|141597459|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank|||||||<0.00001
71043975|NCT00255151|141597459|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank|||||||<0.00001
71043976|NCT00255151|141597459|SUPERIORITY_OR_OTHER|||||||0.37161||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Log Rank|||||||0.37161
71043977|NCT00255151|141597460|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
71043978|NCT00255151|141597460|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
71043979|NCT00255151|141597460|SUPERIORITY_OR_OTHER|||||||0.597||95.0||||Statistical significance was determined at the 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.59700
71043980|NCT00107042|141597462|SUPERIORITY_OR_OTHER|||||||0.2954|||||||Fisher Exact|||The study wasn't powered to compare the 2 arms but to detect a large difference. A quantitative antibody (a'body) response was measured, but for sample size and power considerations, the outcome was considered to be binary. The primary analysis involved straightforward computation of point estimates and exact confidence intervals of immunogenicity in each arm. The data for primary analysis used the Intent-to-Treat for subjects who were vaccinated at least once. Missing titers were not imputed.||||0.2954
71043981|NCT00107042|141597462|SUPERIORITY_OR_OTHER||Response Rate|87.23|||||TWO_SIDED|95.0|74.26|95.17|||95% confidence interval|||"Two-sided confidence intervals (CI) were calculated for both the Recombivax and Twinrix arms. The CI for the Recombivax arm is presented here."||95.17|74.26|
71004465|NCT03774875|141517071|SUPERIORITY||Least Squares (LS) Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|0.95|<|0.0001|TWO_SIDED|95.0|-7.15|-3.43|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and baseline value as a covariate.|Difference in LS Means = Apremilast - Placebo|||-3.43|-7.15|<0.0001
71004466|NCT03774875|141517072|SUPERIORITY||LS Mean Difference|-38.4|STANDARD_ERROR_OF_MEAN|14.12||0.0085|TWO_SIDED|95.0|-66.58|-10.14|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate variable.|LS Mean Difference = Apremilast - Placebo|||-10.14|-66.58|0.0085
71004467|NCT03774875|141517073|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.38|<|0.0001|TWO_SIDED|95.0|-2.34|-0.86|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||-0.86|-2.34|<0.0001
71043982|NCT00107042|141597462|SUPERIORITY_OR_OTHER||Response Rate|94.55|||||TWO_SIDED|95.0|84.88|98.86|||95% confidence interval|||"Two-sided confidence intervals (CI) were calculated for both the Recombivax and Twinrix arms. The CI for the 'Twinrix arm is presented here."||98.86|84.88|
71101342|NCT01421459|141710782|SUPERIORITY_OR_OTHER|||||||0.86||95.0||||P-value is for Worry domain at 12 weeks.|ANCOVA|||||||0.860
71101343|NCT01421459|141710782|SUPERIORITY_OR_OTHER|||||||0.966||95.0||||P-value is for Worry domain at Endpoint, up to 24 weeks.|ANCOVA|||||||0.966
71101344|NCT01421459|141710782|SUPERIORITY_OR_OTHER|||||||0.313||95.0||||P-value is for ALBSS Total Score at 4 weeks.|ANCOVA|||||||0.313
71101345|NCT01421459|141710782|SUPERIORITY_OR_OTHER|||||||0.683||95.0||||P-value is for ALBSS Total Score at 12 weeks.|ANCOVA|||||||0.683
71101346|NCT01421459|141710782|SUPERIORITY_OR_OTHER|||||||0.765||95.0||||P-value is for ALBSS Total Score at Endpoint, up to 24 weeks.|ANCOVA|||||||0.765
71101347|NCT01421459|141710783|SUPERIORITY_OR_OTHER|||||||0.983||95.0||||P-value is for Inconvenience of Regimen at 4 weeks.|ANCOVA|||||||0.983
71101348|NCT01421459|141710783|SUPERIORITY_OR_OTHER|||||||0.371||95.0||||P-value is for Inconvenience of Regimen at 12 weeks.|ANCOVA|||||||0.371
71004468|NCT03774875|141517074|SUPERIORITY||LS Mean Difference|-16.1|STANDARD_ERROR_OF_MEAN|4.31||0.0003|TWO_SIDED|95.0|-24.63|-7.6|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||-7.60|-24.63|0.0003
71004469|NCT03774875|141517075|SUPERIORITY||Adjusted Difference in Response Rates|13.5|STANDARD_ERROR_OF_MEAN|6.3||0.0328|TWO_SIDED|95.0|1.1|25.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification of the 5 difficult to treat manifestation types at randomization.|The adjusted difference in response rates (Apremilast - Placebo) using the weighted average of the treatment differences across the strata with the CMH weights.|||25.8|1.1|0.0328
71004470|NCT03774875|141517076|SUPERIORITY||Adjusted Difference in Response Rates|37.0|STANDARD_ERROR_OF_MEAN|6.58|<|0.0001|TWO_SIDED|95.0|24.1|49.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the stratification of the 5 difficult to treat manifestation types at randomization.|Adjusted difference (Apremilast - Placebo) in response rates using the weighted average of the treatment differences across the strata with the CMH weights.|||49.9|24.1|<0.0001
71004471|NCT03774875|141517077|SUPERIORITY||LS Mean Difference|14.9|STANDARD_ERROR_OF_MEAN|18.55||0.4216|TWO_SIDED|95.0|-21.62|51.48|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||51.48|-21.62|0.4216
71004472|NCT03774875|141517078|SUPERIORITY||LS Mean Difference|-148.024|STANDARD_ERROR_OF_MEAN|103.9525||0.1559|TWO_SIDED|95.0|-352.8793|56.8304|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||56.8304|-352.8793|0.1559
71004473|NCT03774875|141517079|SUPERIORITY||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|2.82||0.2667|TWO_SIDED|95.0|-2.43|8.73|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||8.73|-2.43|0.2667
71004474|NCT03774875|141517080|SUPERIORITY||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|4.23||0.562|TWO_SIDED|95.0|-10.83|5.91|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||5.91|-10.83|0.5620
71004475|NCT03774875|141517081|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|4.81||0.8927|TWO_SIDED|95.0|-10.16|8.86|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||8.86|-10.16|0.8927
71004476|NCT03774875|141517082|SUPERIORITY||LS Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|4.09||0.0572|TWO_SIDED|95.0|-15.9|0.24|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||0.24|-15.90|0.0572
71004477|NCT05706623|141517108|OTHER|Analysis of variance model|Geometric least squares (LS) mean ratio|0.8354|||||TWO_SIDED|90.0|0.5216|1.338||||||Moderate Hepatic Impairment Group (test) versus Normal Hepatic Function Group (reference). The analysis was performed on natural log (ln) transformed parameters using an analysis of variance model with the hepatic function group as a fixed effect.||1.338|0.5216|
71004478|NCT05706623|141517110|OTHER|Analysis of variance model|Geometric LS Mean Ratio|0.9356|||||TWO_SIDED|90.0|0.5889|1.4864||||||Moderate Hepatic Impairment Group (test) versus Normal Hepatic Function Group (reference). The analysis was performed on ln transformed parameters using an analysis of variance model with the hepatic function group as a fixed effect.||1.4864|0.5889|
71004479|NCT03233308|141517120|OTHER|||||||0.001|||||||t-test, 1 sided|||Mean Change from Baseline||||0.0010
71004480|NCT03233308|141517121|OTHER|||||||0.0003|||||||t-test, 1 sided|||Mean change from baseline (percent difference from baseline)||||0.0003
71004481|NCT03233308|141517122|OTHER|||||||0.0687|||||||t-test, 1 sided|||Mean change from baseline -EVP||||0.0687
71004482|NCT03233308|141517122|OTHER||||||<|0.0001|||||||t-test, 1 sided|||Mean change from baseline -IOP||||<0.0001
71004483|NCT03233308|141517123|OTHER|||||||0.0087|||||||t-test, 1 sided|||Mean change from baseline (percent difference from baseline) -EVP||||0.0087
71004484|NCT03233308|141517123|OTHER||||||<|0.0001|||||||t-test, 1 sided|||Mean change from baseline (percent difference from baseline)- IOP||||<0.0001
71004485|NCT03797144|141517168|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.06|||||||t-test, 1 sided|||"To verify that the improvement of ODI from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_ODI ≤ 0, and the alternative hypothesis was Ha: μ\_ODI \> 0 where μ\_ODI is the mean improvement of ODI score at 3 months from baseline."||||0.06
71043983|NCT00107042|141597463|SUPERIORITY_OR_OTHER|||||||0.0608|||||||Wilcoxon (Mann-Whitney)|||Analysis included an assessment of quantitative titer values in each of the two arms using confidence intervals and examining the frequency distributions of the titers in each arm. Transformations were considered (log10) for the titers based on the distributional properties observed in the sample, with the goal of attaining approximate normality of the transformed data.||||0.0608
71043984|NCT00107042|141597463|SUPERIORITY_OR_OTHER||Mean response|2.29|||||TWO_SIDED|95.0|2.05|2.53|||95% confidence interval|||"Two-sided confidence intervals (CI) were calculated for both the Recombivax and Twinrix arms. The CI for the Recombivax arm is presented here."||2.53|2.05|
71043985|NCT00107042|141597463|SUPERIORITY_OR_OTHER||Response rate|2.58|||||TWO_SIDED|95.0|2.4|2.76|||95% confidence interval|||"Two-sided confidence intervals (CI) were calculated for both the Recombivax and Twinrix arms. The CI for the Twinrix arm is presented here."||2.76|2.40|
71043986|NCT00107042|141597466|SUPERIORITY_OR_OTHER||Regression coefficient|0.2455|STANDARD_ERROR_OF_MEAN|0.1757||0.1667|||||||Regression, Linear|||This is a regression analysis for testing the effect of treatment arm (Recombivax vs. Twinrix) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.1667
71043987|NCT00107042|141597466|SUPERIORITY_OR_OTHER||Regression coefficent|-0.0025|STANDARD_ERROR_OF_MEAN|0.1792||0.989||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of site effect(Other sites vs. Baltimore) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.9890
71101349|NCT01421459|141710783|SUPERIORITY_OR_OTHER|||||||0.757||95.0||||P-value is for Inconvenience of Regimen at Endpoint, up to 24 weeks.|ANCOVA|||||||0.757
71004486|NCT03797144|141517168|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.012|||||||t-test, 1 sided|||"To verify that the improvement of ODI from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_ODI ≤ 0, and the alternative hypothesis was Ha: μ\_ODI \> 0 where μ\_ODI is the mean improvement of ODI score at 3 months from baseline."||||0.012
71004487|NCT03797144|141517169|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.002||||||Back Pain|t-test, 1 sided|||"To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_VAS ≤ 0, and the alternative hypothesis was Ha: μ\_VAS \> 0 where μ\_VAS is the mean improvement of VAS score at 3 months from baseline."||||0.002
71004488|NCT03797144|141517169|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."|||||<|0.001||||||Back Pain|t-test, 1 sided|||"To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_VAS ≤ 0, and the alternative hypothesis was Ha: μ\_VAS \> 0 where μ\_VAS is the mean improvement of VAS score at 3 months from baseline."||||<0.001
71004489|NCT03797144|141517169|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."|||||<|0.001||||||Leg Pain|t-test, 1 sided|||"To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_VAS ≤ 0, and the alternative hypothesis was Ha: μ\_VAS \> 0 where μ\_VAS is the mean improvement of VAS score at 3 months from baseline."||||<0.001
71004490|NCT03797144|141517169|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."|||||<|0.001||||||Leg Pain|t-test, 1 sided|||"To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_VAS ≤ 0, and the alternative hypothesis was Ha: μ\_VAS \> 0 where μ\_VAS is the mean improvement of VAS score at 3 months from baseline."||||<0.001
71004491|NCT03797144|141517170|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.174||||||Health State Score|t-test, 1 sided|||"To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ\_EQ-5D 5L \> 0 where μ\_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline."||||0.174
71004492|NCT03797144|141517170|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.002||||||Health State Score|t-test, 1 sided|||"To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ\_EQ-5D 5L \> 0 where μ\_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline."||||0.002
71004493|NCT03797144|141517170|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.003||||||Index score|t-test, 1 sided|||"To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ\_EQ-5D 5L \> 0 where μ\_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline."||||0.003
71004494|NCT03797144|141517170|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.012||||||Index score|t-test, 1 sided|||"To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ\_EQ-5D 5L \> 0 where μ\_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline."||||0.012
71004495|NCT00376675|141517187|SUPERIORITY_OR_OTHER|||||||0.317|||||||Wilcoxon rank sum test|||||||0.317
71101350|NCT01421459|141710783|SUPERIORITY_OR_OTHER|||||||0.89||95.0||||P-value is for Lifestyle Flexibility at 4 weeks.|ANCOVA|||||||0.890
71101351|NCT01421459|141710783|SUPERIORITY_OR_OTHER|||||||0.326||95.0||||P-value is for Lifestyle Flexibility at 12 weeks.|ANCOVA|||||||0.326
71101352|NCT01421459|141710783|SUPERIORITY_OR_OTHER|||||||0.831||95.0||||P-value is for Lifestyle Flexibility at Endpoint, up to 24 weeks.|ANCOVA|||||||0.831
71101353|NCT01421459|141710783|SUPERIORITY_OR_OTHER|||||||0.507||95.0||||P-value is for Hypoglycemic Control at 4 weeks.|ANCOVA|||||||0.507
71101354|NCT01421459|141710783|SUPERIORITY_OR_OTHER|||||||0.69||95.0||||P-value is for Hypoglycemic Control at 12 weeks.|ANCOVA|||||||0.690
71101355|NCT01421459|141710783|SUPERIORITY_OR_OTHER|||||||0.307||95.0||||P-value is for Hypoglycemic Control at Endpoint, up to 24 weeks.|ANCOVA|||||||0.307
71101356|NCT01421459|141710783|SUPERIORITY_OR_OTHER|||||||0.902||95.0||||P-value is for Glycemic Control at 4 weeks.|ANCOVA|||||||0.902
71101357|NCT01421459|141710783|SUPERIORITY_OR_OTHER|||||||0.109||95.0||||P-value is for Glycemic Control at 12 weeks.|ANCOVA|||||||0.109
71101358|NCT01421459|141710783|SUPERIORITY_OR_OTHER|||||||0.754||95.0||||P-value is for Glycemic Control at Endpoint, up to 24 weeks.|ANCOVA|||||||0.754
71004496|NCT00995215|141517196|OTHER|Statistical analysis was performed using a repeated measures analysis of variance and paired t-test.||||||0.05||||||A P value \<0.05 was taken as indicative of statistical significance.|ANOVA|||The effects of electrical (spinal cord stimulation) SCS with disc electrode and wire leads on airway pressure generation were compared. Since SCS with the disc leads, when applied in clinical trials, resulted in airway pressure generation that approximated pressures generated with a normal maximum cough, airway pressure generation achieved during SCS with these leads served as our gold standard to which all comparisons were made.||||0.05
71004497|NCT01332851|141517217|SUPERIORITY||Cox Proportional Hazard|2.5|||=|0.043|TWO_SIDED|95.0|1.03|6.1||We used a threshold of p \< .05 as the criterion for statistical significance.|Regression, Cox||The hazard ratio of 2.5 indicates that children with parents in the control group were 2.5 times more likely to be removed from their home and placed into foster care compared to the intervention group.|Child welfare system removals were analyzed with a survival models that used condition assignment to predict hazard of being removed from the birth parent home.||6.10|1.03|=.043
71004498|NCT01332851|141517218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.94|STANDARD_ERROR_OF_MEAN|0.42|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Parents in the PFR condition were 0.94 higher on sensitivity scores (on the unstandardized sensitivity measure) across the three post-intervention time points than parents in the R\&R condition. The standard error (SE) of this difference was .42.|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline sensitivity score, months between baseline and end of intervention, and age of child at baseline.||||<.05
71004499|NCT01332851|141517219|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.03|>|0.05|TWO_SIDED||||||Mixed Models Analysis||The PFR group had a higher mean compared to the R\&R group. (the absolute value of the standardized effect is d=.15).|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline security score, months between baseline and end of intervention, and age of child at baseline||||>.05
71043988|NCT00107042|141597466|SUPERIORITY_OR_OTHER||Regression coeffcient|0.2053|STANDARD_ERROR_OF_MEAN|0.1885||0.2796||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of age(15 - 17 year old particpants vs. 12 - 14 year old participants) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.2796
71043989|NCT00107042|141597466|SUPERIORITY_OR_OTHER||Regresssion coeffcient|-0.4726|STANDARD_ERROR_OF_MEAN|0.1734||0.008||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of gender(Females vs. Males) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.0080
71043990|NCT00107042|141597466|SUPERIORITY_OR_OTHER||Regression coefficient|0.2189|STANDARD_ERROR_OF_MEAN|0.1905||0.2543||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Hispanic ethnicity (Not Hispanic vs. Hispanic) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.2543
71043991|NCT00107042|141597466|SUPERIORITY_OR_OTHER||Regression coefficient|0.2994|STANDARD_ERROR_OF_MEAN|0.3292||0.3661||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of racial background(White vs. Other/Mixed vs. Black/African American) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between White vs. Other/Mixed Race is presented.||||0.3661
71043992|NCT00107042|141597466|SUPERIORITY_OR_OTHER||Regression coefficient|0.0083|STANDARD_ERROR_OF_MEAN|0.3497||0.9812||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of racial background(White vs. Other/Mixed vs. Black/African American) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between White vs. Black/African American is presented.||||0.9812
71043993|NCT00107042|141597466|SUPERIORITY_OR_OTHER||Regression coefficient|-0.0663|STANDARD_ERROR_OF_MEAN|0.2314||0.7766||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Tanner Stage for Females(Stage 5 vs. Stages 1 - 4) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.7766
71043994|NCT00107042|141597466|SUPERIORITY_OR_OTHER||Regression coefficient|-0.2929|STANDARD_ERROR_OF_MEAN|0.2508||0.2492||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Tanner Stage for Males(Stage 5 vs. Stages 1 - 4) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.2492
71043995|NCT00107042|141597466|SUPERIORITY_OR_OTHER||Regression coeffcient|-0.316|STANDARD_ERROR_OF_MEAN|0.1826||0.0877||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of BMI at Baseline(Normal and Underweight (\<25.0) vs. Overweight and Obsese (\>= 25.0)) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.0877
71043996|NCT00107042|141597466|SUPERIORITY_OR_OTHER||Regression coefficient|-0.0292|STANDARD_ERROR_OF_MEAN|0.0113||0.0117||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of BMI at Baseline(continuous variable) on vaccine response as measured in log10 titers.||||0.0117
71101359|NCT01421459|141710783|SUPERIORITY_OR_OTHER|||||||0.088||95.0||||P-value is for Insulin Deliver Device at 4 weeks.|ANCOVA|||||||0.088
71101360|NCT01421459|141710783|SUPERIORITY_OR_OTHER|||||||0.456||95.0||||P-value is for Insulin Delivery Device at 12 weeks.|ANCOVA|||||||0.456
71101361|NCT01421459|141710783|SUPERIORITY_OR_OTHER|||||||0.531||95.0||||P-value is for Insulin Delivery Device at Endpoint, up to 24 weeks.|ANCOVA|||||||0.531
71101362|NCT01421459|141710783|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||P-value is for ITSQ Total Score at 4 weeks.|ANCOVA|||||||0.393
71101363|NCT01421459|141710783|SUPERIORITY_OR_OTHER|||||||0.296||95.0||||P-value is for ITSQ Total Score at 12 weeks.|ANCOVA|||||||0.296
71101364|NCT01421459|141710783|SUPERIORITY_OR_OTHER|||||||0.662||95.0||||P-value is for ITSQ Total Score at Endpoint, up to 24 weeks.|ANCOVA|||||||0.662
71101365|NCT01421459|141710784|SUPERIORITY_OR_OTHER|||||||0.393||95.0|||||ANCOVA|||||||0.393
71101366|NCT01421459|141710785|SUPERIORITY_OR_OTHER|||||||0.185||95.0||||P-value is for Insulin Dose at Endpoint, up to 24 weeks.|ANOVA|||||||0.185
71101367|NCT01421459|141710786|SUPERIORITY_OR_OTHER|||||||0.661||95.0||||P-value is for HbA1c \<7% at Baseline.|Chi-squared|||||||0.661
71004500|NCT01332851|141517220|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.5|>|0.05|TWO_SIDED||||||Mixed Models Analysis||The adjusted mean across the two post-intervention time points was -.20 (SE=.50) lower in the PFR group than R\&R group. The standardized effect size was d=.04.|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline problem behavior score, months between baseline and end of intervention, and age of child at baseline.||||>.05
71004501|NCT01332851|141517221|SUPERIORITY||Mean Difference (Net)|0.41|STANDARD_ERROR_OF_MEAN|0.53|>|0.05|TWO_SIDED||||||Mixed Models Analysis||The adjusted mean across post-intervention time points was .41 (SE=.53) higher in the PFR group than the R\&R group. The standardized effect size was d=-.07|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline competence stress score, months between baseline and end of intervention, and age of child at baseline||||>.05
71004502|NCT01332851|141517222|SUPERIORITY||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.25|>|0.05|TWO_SIDED||||||Mixed Models Analysis||The PFR group had a higher mean level of social and emotional development compared to the R\&R group (the absolute value of the standardized effect is d=.10).|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline social-emotional competence score, months between baseline and end of intervention, and age of child at baseline.||||>.05
71004503|NCT01332851|141517223|SUPERIORITY||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|0.66|>|0.05|TWO_SIDED||||||Mixed Models Analysis||The PFR group had lower mean level of problem behavior compared to the R\&R group (the absolute value of standardized effect is d= .12).|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline problem behavior score, months between baseline and end of intervention, and age of child at baseline||||>.05
71004504|NCT01332851|141517224|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED||||||Regression, Linear||Adjusted mean at 3-month post-intervention was -.07 (SE=.08) lower for PFR compared to R\&R group.|Tested mean differences by condition at 3-month follow-up controlling for baseline score, months between baseline and the end of the intervention, and age of child and using an ANVOVA/regression model. Null hypothesis was that post-intervention means were equal.||||>.05
71004505|NCT01332851|141517225|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED||||||Regression, Linear||Adjusted mean at 3-month post-intervention was -.06 (SE=.08) lower for PFR compared to R\&R group.|||||>.05
71004506|NCT01332851|141517226|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.04|<|0.05|TWO_SIDED||||||Mixed Models Analysis||The PFR group had lower atypical affective communication compared to the R\&R group (the absolute value of the standardized effect size was d=.19).|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline score, months between baseline and end of intervention, and age of child at baseline||||<.05
71004507|NCT01678560|141517259|OTHER|Exact Fisher test was used on the collected information from the limited population|Fisher exact test statistic value|1.0|||<|0.01|TWO_SIDED|||||Hypothesis: Active continuous monitoring of PAP treatment in OSA will result in improved adherence at 90 days Exact Fisher test was used on the collected information from the limited population.|Fisher Exact|Exact Fisher test was used on the information from the limited population.||PAP devices delivery to the patients was outsourced by the institution eliminating the point of recruitment for the study at our department. The recruitment was halted and the study proceeded with the follow-up of already recruited patients. As a result of the limited recruitment, planned statistical data analysis was not performed on the primary outcomes due to the smaller then expected number of subjects (expected 110 subjects in the Usual arm and 110 subjects in the Wireless arm.|Exact Fisher test was used on the collected information from the limited population.|||<0.01
71004508|NCT01678560|141517260|OTHER|Exact Fisher test was used on the collected information from the limited population|Fisher exact test statistic value|1.0|||<|0.01|TWO_SIDED|||||"Hypothesis: Active continuous monitoring of PAP treatment in OSA (Wireless group) will result in improved adherence at 90 days compared to Usual Group.~Exact Fisher test was used on the collected information from the limited population."|Fisher Exact|Exact Fisher test was used on the information from the limited population||CPAP devices delivery to the patients was outsourced by the institution eliminating the point of recruitment for the study at our department The recruitment was halted and the study proceeded with the follow-up of already recruited patients. As a result of the limited recruitment, planned statistical data analysis was not performed on the primary outcomes due to the smaller then expected number of subjects (expected 110 subjects in the Usual arm and 110 subjects in the Wireless arm|Exact Fisher test was used on the collected information from the limited population|||<0.01
71101368|NCT01421459|141710786|SUPERIORITY_OR_OTHER|||||||0.394||95.0||||P-value is for HbA1c ≤ 6.5% at Baseline.|Chi-squared|||||||0.394
71008643|NCT02055976|141525237|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.8055|STANDARD_ERROR_OF_MEAN|0.8615||0.176|TWO_SIDED|95.0|-0.9066|2.5177|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||2.5177|-0.9066|0.176
71008644|NCT02055976|141525237|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.0071|STANDARD_ERROR_OF_MEAN|0.8641||0.011|TWO_SIDED|95.0|0.2899|3.7242|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||3.7242|0.2899|0.011
71101369|NCT01421459|141710786|SUPERIORITY_OR_OTHER|||||||0.688||95.0||||P-value is for HbA1c \<7% at 4 weeks.|Chi-squared|||||||0.688
71004509|NCT01678560|141517261|OTHER|Exact Fisher test was used on the collected information from the limited population|Estimation Parameter Other[Fisher exact|1.0|||<|0.01|TWO_SIDED|||||Hypothesis - Number of patients effectively treated with the PAP will be higher in the Wireless Group compared to the Usual Group Exact Fisher test was used on the collected information from the limited population.|Fisher Exact|||CPAP devices delivery to the patients was outsourced by the institution eliminating the point of recruitment for the study at our department The recruitment was halted and the study proceeded with the follow-up of already recruited patients. As a result of the limited recruitment, planned statistical data analysis was not performed on the primary outcomes due to the smaller then expected number of subjects (expected 110 subjects in the Usual arm and 110 subjects in the Wireless arm.||||<0.01
71004510|NCT01678560|141517262|OTHER|Exact Fisher test was used on the collected information from the limited population|Other[Fisher exact test statistic value]|0.0286|||<|0.01|TWO_SIDED|||||Hypothesis - PAP treatment Adherence in the first 3 months of treatment predicts the PAP treatment Adherence in the next 9 months of treatment Exact Fisher test was used on the collected information from the limited population|Fisher Exact||Exact Fisher test was used on the collected information from the limited population.|Exact Fisher test was used on the collected information from the limited population|Exact Fisher test was used on the collected information from the limited population.|||<0.01
71004511|NCT01678560|141517263|OTHER|Exact Fisher test was used on the collected information from the limited population|Exact Fisher test|0.0039|||<|0.01|TWO_SIDED|||||"Hypothesis: Patients with the higher AHI are more likely to become adherent to the PAP therapy.~Exact Fisher test was used on the collected information from the limited population"|Fisher Exact|Exact Fisher test was used on the collected information from the limited population||Exact Fisher test was used on the collected information from the limited population|Exact Fisher test was used on the collected information from the limited population|||<0.01
71004512|NCT01828567|141517274|OTHER|A logistic regression model was used. The null hypothesis is that there is no difference in improvement prevention program enrollment between the usual care and intervention arms by month 6.|Odds Ratio (OR)|2.54|||<|0.0001|TWO_SIDED|95.0|1.66|3.89|||Regression, Logistic|||The first primary outcome is the cumulative enrollment in prevention programs over the six months of follow up. This will be assessed via self-report at months 1 and 6. As defined by the eligibility criteria, all patients will have a value of 0 at baseline.||3.89|1.66|<.0001
71004513|NCT01828567|141517276|OTHER||Mean Difference (Final Values)|1.5||||0.204|TWO_SIDED|95.0|-0.8|3.7||A general linear model with an unstructured covariance matrix to take into account the within-patient correlation between repeated measures over time.|Repeated Measures|This model assumes the groups have equal baseline means.|We estimate the parameters in the model using the SAS procedure MIXED (SAS Version 9.4, Cary, NC). The null hypothesis is that there is no difference in improvement in PAM scores between the usual care and intervention arms at 1 month.|For the primary hypothesis we will be examining the effect during the 1-month long intervention delivery period.||3.7|-0.8|0.204
71004514|NCT01828567|141517277|EQUIVALENCE|This model assumes the groups have equal baseline means, which is appropriate for a randomized controlled trial and is equivalent in efficiency to an ANCOVA model.|Mean Difference (Final Values)|2.5||||0.03|TWO_SIDED|95.0|0.2|4.7||A general Linear model with an unstructured covariance matrix to take into account the within-patient correlation between repeated measures over time. For the primary hypothesis we will be assessing sustainability at 6 months.|Repeated Measures|This model assumes the groups have equal baseline means.|We estimate the parameters in the model using the SAS procedure MIXED (SAS Version 9.4, Cary, NC). The null hypothesis is that there is no difference in improvement in PAM scores between the usual care and intervention arms at 6 month.|||4.7|0.2|0.030
71004515|NCT01828567|141517279|EQUIVALENCE|This model assumes the groups have equal baseline means|Mean Difference (Final Values)|0.7||||0.33|TWO_SIDED|95.0|-0.7|2.2|||Repeated Measures|A general linear model with an unstructured covariance matrix to take into account the within-patient correlation between repeated measures over time.|We estimate the parameters in the model using the SAS procedure MIXED (SAS Version 9.4, Cary, NC). The null hypothesis is that there is no difference in improvement in FRS scores between the usual care and intervention arms at 6 month.|Our secondary outcome of interest is the Framingham Risk Score, measured at baseline and month 6.||2.2|-0.7|0.330
70924695|NCT04321031|141342046|SUPERIORITY||Risk Difference (RD)|0.08|||||TWO_SIDED|90.0|-0.04|0.3||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.30|-0.04|
70924696|NCT04321031|141342046|SUPERIORITY||Risk Difference (RD)|0.13|||||TWO_SIDED|50.0|0.06|0.24||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.24|0.06|
70924697|NCT04321031|141342046|SUPERIORITY||Risk Difference (RD)|0.13|||||TWO_SIDED|90.0|-0.01|0.44||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.44|-0.01|
70924698|NCT04321031|141342047|SUPERIORITY||Risk Difference (RD)|0.18|||||TWO_SIDED|90.0|0.05|0.31|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.31|0.05|
70924699|NCT04321031|141342047|SUPERIORITY||Risk Difference (RD)|0.23|||||TWO_SIDED|90.0|0.09|0.36|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.36|0.09|
70924700|NCT04321031|141342047|SUPERIORITY||Risk Difference (RD)|0.25|||||TWO_SIDED|90.0|0.1|0.38|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.38|0.10|
71004516|NCT00804986|141517296|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.47||||0.0109|TWO_SIDED|95.0|-0.83|-0.11||p-value represents change from baseline to Week 12 HbA1c for 0.5 mg treatment arm in comparison to placebo with values \<0.05 considered to be statistically significant.|Mixed Models Analysis|Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction||||-0.11|-0.83|0.0109
71004517|NCT00804986|141517296|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.67||||0.0003|TWO_SIDED|95.0|-1.02|-0.31||p-value represents change from baseline to week 12 HbA1c for 2.0 mg treatment arm in comparison to placebo with values \<0.05 considered to be statistically significant.|Mixed Models Analysis|Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction||||-0.31|-1.02|0.0003
71004518|NCT00804986|141517296|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-1.11|||<|0.0001|TWO_SIDED|95.0|-1.46|-0.76||p-value represents change from baseline to Week 12 HbA1c for 6.2 mg treatment arm in comparison to placebo with values \<0.05 considered to be statistically significant.|Mixed Models Analysis|Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction||||-0.76|-1.46|<0.0001
70924701|NCT04321031|141342047|SUPERIORITY||Risk Difference (RD)|0.27|||||TWO_SIDED|90.0|0.11|0.4|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.40|0.11|
70924702|NCT04321031|141342048|SUPERIORITY||Risk Difference (RD)|0.14|||||TWO_SIDED|90.0|-0.04|0.36||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.36|-0.04|
70924703|NCT04321031|141342048|SUPERIORITY||Risk Difference (RD)|0.35|||||TWO_SIDED|90.0|0.15|0.53||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.53|0.15|
70924704|NCT04321031|141342048|SUPERIORITY||Risk Difference (RD)|0.26|||||TWO_SIDED|90.0|0.06|0.46||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.46|0.06|
70924705|NCT04321031|141342048|SUPERIORITY||Risk Difference (RD)|0.48|||||TWO_SIDED|90.0|0.27|0.63||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.63|0.27|
70924706|NCT04321031|141342048|SUPERIORITY||Risk Difference (RD)|0.16|||||TWO_SIDED|90.0|-0.03|0.38||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.38|-0.03|
70924707|NCT04321031|141342048|SUPERIORITY||Risk Difference (RD)|0.4|||||TWO_SIDED|90.0|0.18|0.58||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.58|0.18|
70924708|NCT04321031|141342048|SUPERIORITY||Risk Difference (RD)|0.22|||||TWO_SIDED|50.0|0.15|0.28||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.28|0.15|
70924709|NCT04321031|141342048|SUPERIORITY||Risk Difference (RD)|0.22|||||TWO_SIDED|90.0|0.03|0.35||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.35|0.03|
70924710|NCT04321031|141342048|SUPERIORITY||Risk Difference (RD)|0.24|||||TWO_SIDED|50.0|0.16|0.32||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.32|0.16|
70924711|NCT04321031|141342048|SUPERIORITY||Risk Difference (RD)|0.24|||||TWO_SIDED|90.0|0.03|0.42||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.42|0.03|
71004519|NCT00804986|141517296|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-1.28|||<|0.0001|TWO_SIDED|95.0|-1.64|-0.93||p-value represents change from baseline to Week 12 HbA1c for 12.0 mg treatment arm in comparison to placebo with values \<0.05 considered to be statistically significant.|Mixed Models Analysis|Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction||||-0.93|-1.64|<0.0001
71101370|NCT01421459|141710786|SUPERIORITY_OR_OTHER||||||>|0.999||95.0||||P-value is for HbA1c ≤ 6.5% at 4 weeks.|Chi-squared|||||||>0.999
71101371|NCT01421459|141710786|SUPERIORITY_OR_OTHER|||||||0.409||95.0||||P-value is for HbA1c \<7% at 8 weeks.|Chi-squared|||||||0.409
71004520|NCT00804986|141517296|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-1.24|||<|0.0001|TWO_SIDED|95.0|-1.59|-0.88||p-value represents change from baseline to Week 12 HbA1c for 17.6 mg treatment arm in comparison to placebo with values \<0.05 considered to be statistically significant.|Mixed Models Analysis|Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction||||-0.88|-1.59|<0.0001
71004521|NCT00804986|141517297|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|1.93||||0.655||95.0||||p-value represents change from baseline to Week 12 for hunger, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.655
71004522|NCT00804986|141517297|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|3.36||||0.436||95.0||||p-value represents change from baseline to Week 12 for hunger, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.436
71004523|NCT00804986|141517297|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|0.45||||0.914||95.0||||p-value represents change from baseline to Week 12 for hunger, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.914
71004524|NCT00804986|141517297|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|3.3||||0.446||95.0||||p-value represents change from baseline to Week 12 for hunger, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.446
71004525|NCT00804986|141517297|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|2.84||||0.508||95.0||||p-value represents change from baseline to Week 12 for hunger, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.508
71004526|NCT00804986|141517297|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|2.89||||0.561||95.0||||p-value represents change from baseline to Week 12 for how full, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.561
71004527|NCT00804986|141517297|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-7.4||||0.135||95.0||||p-value represents change from baseline to Week 12 for how full, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.135
71004528|NCT00804986|141517297|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-4.45||||0.357||95.0||||p-value represents change from baseline to Week 12 for how full, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.357
71004529|NCT00804986|141517297|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-8.05||||0.105||95.0||||p-value represents change from baseline to Week 12 for how full, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.105
71004530|NCT00804986|141517297|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-6.02||||0.221||95.0||||p-value represents change from baseline to Week 12 for how full, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.221
71004531|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-4.54||||0.4848||95.0||||p-value represents change from baseline to Week 12 for fasting glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.4848
71004532|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-19.48||||0.0029||95.0||||p-value represents change from baseline to Week 12 for fasting glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0029
71004533|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-32.52|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for fasting glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
71004534|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-30.45|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for fasting glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
71004535|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-35.25|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for fasting glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
71004536|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-5.32||||0.6279||95.0||||p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.6279
71004537|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-29.72||||0.0072||95.0||||p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0072
71101372|NCT01421459|141710786|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||P-value is for HbA1c ≤ 6.5% at 8 weeks.|Chi-squared|||||||0.090
71101373|NCT01421459|141710786|SUPERIORITY_OR_OTHER|||||||0.319||95.0||||P-value is for HbA1c \<7% at 12 weeks.|Chi-squared|||||||0.319
71101374|NCT01421459|141710786|SUPERIORITY_OR_OTHER|||||||0.463||95.0||||P-value is for HbA1c ≤6.5% at 12 weeks.|Chi-squared|||||||0.463
71101375|NCT01421459|141710786|SUPERIORITY_OR_OTHER|||||||0.128||95.0||||P-value is for HbA1c \<7% at 16 weeks.|Chi-squared|||||||0.128
71101376|NCT01421459|141710786|SUPERIORITY_OR_OTHER|||||||0.261||95.0||||P-value is for HbA1c ≤6.5% at 16 weeks.|Chi-squared|||||||0.261
71101377|NCT01421459|141710786|SUPERIORITY_OR_OTHER|||||||0.218||95.0||||P-value is for HbA1c \<7% at 20 weeks.|Chi-squared|||||||0.218
71101378|NCT01421459|141710786|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||P-value is for HbA1c ≤6.5% at 20 weeks.|Chi-squared|||||||0.092
71004538|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-42.49|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
71004539|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-43.05||||0.0001||95.0||||p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0001
71004540|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-51.38|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
71043997|NCT00107042|141597466|SUPERIORITY_OR_OTHER||Regression coefficient|-0.0578|STANDARD_ERROR_OF_MEAN|0.2163||0.7899||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of smokng cigarettes(Never Smoked vs. Has Smoked) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.7899
71043998|NCT00107042|141597466|SUPERIORITY_OR_OTHER||Regression coefficient|-0.5339|STANDARD_ERROR_OF_MEAN|0.2803||0.0607||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of sexual identity(Straight (heterosexual) vs. Gay (homosexual), Bi (bisexual), and Not Sure or Undecided) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.0607
71043999|NCT00107042|141597466|SUPERIORITY_OR_OTHER||Regression coefficient|-0.3883|STANDARD_ERROR_OF_MEAN|0.2779||0.167||95.0|||||Regression, Linear|||"This is a regression analysis for testing the effect of age at which the subject first had unforced sex (Never vs. \<= 14 year olds vs. 15-17 year olds) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between never vs. \<= 14 year olds is presented."||||0.1670
71044000|NCT00107042|141597466|SUPERIORITY_OR_OTHER||Regression coefficient|0.0344|STANDARD_ERROR_OF_MEAN|0.2065||0.8682||95.0|||||Regression, Linear|||"This is a regression analysis for testing the effect of age at which subject had first unforced sex (Never vs. \<= 14 year olds vs. 15 - 17 year olds) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between never vs. 15-17 year olds is presented."||||0.8682
71044001|NCT00107042|141597466|SUPERIORITY_OR_OTHER||Regression coefficient|0.1532|STANDARD_ERROR_OF_MEAN|0.1896||0.4219||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of total number of lifetime sex partners (0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. 1-5 partners is presented.||||0.4219
71044002|NCT00107042|141597466|SUPERIORITY_OR_OTHER||Regression coefficient|-0.7752|STANDARD_ERROR_OF_MEAN|0.242||0.002||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Total Number of Lifetime Sex Partners(0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. \>= 6 partners is presented.||||0.0020
71044003|NCT00107042|141597466|SUPERIORITY_OR_OTHER||Regression coefficient|0.2921|STANDARD_ERROR_OF_MEAN|0.2086||0.1659||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Total Number of Male Lifetime Sex Partners(0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. 1-5 partners is presented.||||0.1659
71044004|NCT00107042|141597466|SUPERIORITY_OR_OTHER||Regression coefficient|-1.6163|STANDARD_ERROR_OF_MEAN|0.2839||0||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Total Number of Male Lifetime Sex Partners(0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. \>= 6 partners is presented.||||0.0000
71044005|NCT00107042|141597466|SUPERIORITY_OR_OTHER||Regression coefficient|-0.1788|STANDARD_ERROR_OF_MEAN|0.2463||0.4701||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Total Number of Female Lifetime Sex Partners(0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. 1-5 partners is presented.||||0.4701
71044006|NCT00107042|141597466|SUPERIORITY_OR_OTHER||Regression coefficient|0.1083|STANDARD_ERROR_OF_MEAN|0.3488||0.7572||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Total Number of Female Lifetime Sex Partners(0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. \>= 6 partners is presented.||||0.7572
71044007|NCT00107042|141597466|SUPERIORITY_OR_OTHER||Regression coefficient|-0.0307|STANDARD_ERROR_OF_MEAN|0.1809||0.8657||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of whether a subject ever drank alcohol (No vs. Yes) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.8657
71044008|NCT00107042|141597466|SUPERIORITY_OR_OTHER||Regression coefficient|-0.3548|STANDARD_ERROR_OF_MEAN|0.2076||0.0917||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of whether a subject ever smoked marijuana(No vs. Yes) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.0917
71044009|NCT00107042|141597466|SUPERIORITY_OR_OTHER||Regression coefficient|-0.3474|STANDARD_ERROR_OF_MEAN|0.3924||0.3788||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of whether a subject ever used drugs not prescribed(No vs. Yes) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.3788
71044010|NCT00107042|141597467|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.54||||0.2068|TWO_SIDED|95.0|0.6|10.76|||Univariate regression, logistic||The reference group is the 'Recombivax' group.|||10.76|0.60|0.2068
71044011|NCT00107042|141597468|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.5524|TWO_SIDED|95.0|0.38|6.01|||Univariate regression, logistic||The reference group is the 'Other Sites' group.|||6.01|0.38|0.5524
70924712|NCT04784559|141342079|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.8751|TWO_SIDED|95.0|0.727|1.53||Unadjusted 2-sided p-value, for multiplicity adjustment uses the Hochberg step-up procedure|Log Rank|Stratified log-rank test, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Stratified Cox proportional-hazards regression model, including the fixed effect of the treatment group and levels of the randomisation stratification factors,|Plitidepsin 2.5 mg arm versus Control arm||1.53|0.727|0.8751
70924713|NCT04784559|141342079|SUPERIORITY||Hazard Ratio (HR)|1.37||||0.0625|TWO_SIDED|95.0|0.96|1.96||Unadjusted 2-sided p-value, for multiplicity adjustment uses the Hochberg step-up procedure|Log Rank|Stratified log-rank test, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Stratified Cox proportional-hazards regression model, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Plitidepsin 1.5 mg arm versus Control arm||1.96|0.960|0.0625
70924714|NCT04784559|141342080|SUPERIORITY||Hazard Ratio (HR)|0.948||||0.5945|TWO_SIDED|95.0|0.655|1.37||Unadjusted 2-sided p-value, for multiplicity adjustment uses the Hochberg step-up procedure|Log Rank|Stratified log-rank test, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Stratified Cox proportional-hazards regression model, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Plitidepsin 2.5 mg arm versus Control arm||1.37|0.655|0.5945
70924715|NCT04784559|141342080|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.3358|TWO_SIDED|95.0|0.827|1.7||Unadjusted 2-sided p-value, for multiplicity adjustment uses the Hochberg step-up procedure|Log Rank|Stratified log-rank test, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Stratified Cox proportional-hazards regression model, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Plitidepsin 1.5 mg arm versus Control arm||1.70|0.827|0.3358
70924716|NCT04784559|141342081|SUPERIORITY||Odds Ratio (OR)|1.12||||0.7252|TWO_SIDED|95.0|0.604|2.06||2-sided|p-value based on proportional odds model|Proportional odds model with fixed effects of treatment group and randomisation stratification factors|Adjusted Odds Ratio and 95% CI based on a proportional odds model with fixed effects of treatment group and randomisation stratification factors|Plitidepsin 2.5 mg arm versus Control arm||2.06|0.604|0.7252
70924717|NCT04784559|141342081|SUPERIORITY||Odds Ratio (OR)|1.69||||0.091|TWO_SIDED|95.0|0.92|3.11||2-sided|p-value based on proportional odds model|Proportional odds model with fixed effects of treatment group and randomisation stratification factors|Adjusted Odds Ratio and 95% CI based on a proportional odds model with fixed effects of treatment group and randomisation stratification factors|Plitidepsin 1.5 mg arm versus Control arm||3.11|0.920|0.0910
70924718|NCT03138512|141342086|SUPERIORITY||Cox Proportional Hazard|0.95||||0.6676||95.0|0.75|1.2|||Log Rank|||||1.20|0.75|0.6676
70924719|NCT03138512|141342086|SUPERIORITY||Cox Proportional Hazard|0.93||||0.6556||95.0|0.67|1.28|||Log Rank|||||1.28|0.67|0.6556
70924720|NCT03138512|141342087|SUPERIORITY||Cox Proportional Hazard|1.26||||0.2436||95.0|0.85|1.85|||Log Rank|||Treatment Part A||1.85|0.85|0.2436
70924721|NCT03138512|141342087|SUPERIORITY||Cox Proportional Hazard|1.36||||0.45||95.0|0.61|3.07|||Log Rank|||Treatment Part B||3.07|0.61|0.4500
70924722|NCT03138512|141342089|SUPERIORITY||Cox Proportional Hazard|1.22|||||TWO_SIDED|95.0|0.89|1.67||||||||1.67|0.89|
70924723|NCT03138512|141342090|SUPERIORITY||Cox Proportional Hazard|0.75||||||95.0|0.33|1.68||||||||1.68|0.33|
70924724|NCT03332017|141342099|SUPERIORITY|||||||0.0017|||||||Cochran-Mantel-Haenszel|P-value was stratified by rituximab-refractory status, number of prior lines of therapy, and geographic region per interactive response technology.||||||0.0017
70924725|NCT03661840|141342150|SUPERIORITY||Mean Difference (Final Values)|3.9|STANDARD_ERROR_OF_MEAN|17.0||0.82|TWO_SIDED|95.0|-31.0|39.0||Unadjusted model comparing the mean difference (change from 12 weeks - baseline) in outcome by intervention group.|Regression, Linear|||Sample size was estimated using d= 0.61, with power at 0.80 and α = .05, two-tailed. It is assumed that the correlation between pre and post-test measures will be high at .5. With these parameters and using repeated measures ANOVA to evaluate treatment difference, sample size is powered for clinical outcomes at 92 participants; with an estimated 30% attrition and conservatively including the possibility of screening failures, a maximum sample of 140 participants will be targeted for enrollment.||39|-31|0.82
70924726|NCT03661840|141342151|SUPERIORITY||Mean Difference (Final Values)|12.0|STANDARD_ERROR_OF_MEAN|6.4||0.06|TWO_SIDED|95.0|-0.7|25.0||Unadjusted model comparing the change in outcome by intervention group|Regression, Linear|||||25|-0.7|0.06
70924727|NCT03661840|141342151|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.05|TWO_SIDED||||||ANOVA|||Sample size was estimated using d= 0.61, with power at 0.80 and α = .05, two-tailed. It is assumed that the correlation between pre and post-test measures will be high at .5. With these parameters and using repeated measures ANOVA to evaluate treatment difference, sample size is powered for clinical outcomes at 92 participants; with an estimated 30% attrition and conservatively including the possibility of screening failures, a maximum sample of 140 participants will be targeted for enrollment.||||0.05
71004541|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-20.21||||0.0335||95.0||||p-value represents change from baseline to Week 12 for prior to lunch glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0335
71004542|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-21.91||||0.0221||95.0||||p-value represents change from baseline to Week 12 for prior to lunch glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0221
71004543|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-39.41|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to lunch glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
70924728|NCT02120456|141342197|SUPERIORITY||Rate ratio|0.45|||<|0.001|TWO_SIDED|95.0|0.34|0.58|||Negative binominal regression|||Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||0.58|0.34|<0.001
71004544|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-36.07||||0.0002||95.0||||p-value represents change from baseline to Week 12 for prior to lunch glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0002
70924729|NCT02120456|141342197|SUPERIORITY||Rate ratio|0.56|||<|0.001|TWO_SIDED|95.0|0.44|0.73|||Negative binominal regression|||Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||0.73|0.44|<0.001
70924730|NCT02120456|141342197|SUPERIORITY||Rate ratio|1.26||||0.058|TWO_SIDED|95.0|0.99|1.6|||Negative binominal regression|||||1.60|0.99|0.058
70924731|NCT02120456|141342198|SUPERIORITY||Ratio of clearance rates|1.05||||0.94|TWO_SIDED|95.0|0.3|4.73|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.||4.73|0.30|0.94
70924732|NCT02120456|141342198|SUPERIORITY||Ratio of clearance rates|1.0||||1|TWO_SIDED|95.0|0.28|4.51|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.||4.51|0.28|1.00
70924733|NCT02120456|141342198|SUPERIORITY||Ratio of clearance rates|0.95||||0.93|TWO_SIDED|95.0|0.31|2.89|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.||2.89|0.31|0.93
70924734|NCT02120456|141342199|SUPERIORITY||Ratio of clearance rates|2.88||||0.003|TWO_SIDED|95.0|1.36|7.85|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.||7.85|1.36|0.003
70924735|NCT02120456|141342199|SUPERIORITY||Ratio of clearance rates|2.84||||0.004|TWO_SIDED|95.0|1.35|7.74|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.||7.74|1.35|0.004
70924736|NCT02120456|141342199|SUPERIORITY||Ratio of clearance rates|0.99||||0.95|TWO_SIDED|95.0|0.66|1.47|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.||1.47|0.66|0.95
70924737|NCT05520190|141342201|SUPERIORITY||Standardized Response Mean|-0.47|||||TWO_SIDED||||||||Baseline Attitude score - 1-month Attitude score / SD of average change|||||
70924738|NCT05520190|141342202|SUPERIORITY||Standardized Response Mean|-0.23|||||TWO_SIDED||||||||Baseline Norm score - 1-month Norm score / SD of average change|||||
70924739|NCT05520190|141342203|SUPERIORITY||Standardized Response Mean|-0.03|||||TWO_SIDED||||||||Baseline Perceived Behavioral Control score - 1-month Perceived Behavioral Control score / SD of average change|||||
70924740|NCT05520190|141342204|SUPERIORITY||Standardized Response Mean|-0.16|||||TWO_SIDED||||||||Baseline Intention score - 1-month Intention score / SD of average change|||||
70924741|NCT05520190|141342205|SUPERIORITY||Standardized Response Mean|0.35|||||TWO_SIDED||||||||Baseline drinks per day - 1-month drinks per day / avg change in drinks per day|||||
71004545|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-40.36|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to lunch glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
70924742|NCT05520190|141342206|SUPERIORITY||Standardized Response Mean|0.35|||||TWO_SIDED||||||||Baseline drinking days - 1-month drinking days / SD of avg change in drinking days|||||
70924743|NCT05520190|141342207|SUPERIORITY||Standardized Response Mean|0.3|||||TWO_SIDED||||||||Baseline binge drinking days - 1-month binge drinking days / avg change in binge drinking days|||||
70924744|NCT05520190|141342208|SUPERIORITY||Standardized Response Mean|1.23|||||TWO_SIDED||||||||Baseline depression - 1-month depression / SD of avg change in depression|||||
70924745|NCT05520190|141342209|SUPERIORITY||Standardized Response Mean|1.06|||||TWO_SIDED||||||||Baseline anxiety - 1-month anxiety / SD avg change in anxiety|||||
70924746|NCT05520190|141342210|SUPERIORITY||Standardized Response Mean|0.9|||||TWO_SIDED||||||||Baseline PTSD - 1-month PTSd / SD avg change in PTSD|||||
70924747|NCT05520190|141342211|SUPERIORITY||Standardized Response Mean|0.6|||||TWO_SIDED||||||||Baseline insomnia - 1-month insomnia / SD avg change in insomnia|||||
70924748|NCT05520190|141342212|SUPERIORITY||Standardized Response Mean|0.58|||||TWO_SIDED||||||||Baseline Alcohol Screen - 1-month Alcohol Screen / SD avg change|||||
70924749|NCT05520190|141342213|SUPERIORITY||Standardized Response Mean|-0.39|||||TWO_SIDED||||||||Baseline behavioral beliefs - 1-month behavioral beliefs / avg change in behavioral beliefs|||||
70924750|NCT05520190|141342214|SUPERIORITY||Standardized Response Mean|-0.62|||||TWO_SIDED||||||||Baseline normative beliefs - 1-month normative beliefs / SD avg change in normative beliefs|||||
70924751|NCT05520190|141342215|SUPERIORITY||Standardized Response Mean|-0.83|||||TWO_SIDED||||||||Baseline control beliefs - 1-month control beliefs / SD avg change in control beliefs|||||
70924752|NCT02226276|141342216|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70924753|NCT02226276|141342217|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
70924754|NCT02754882|141342230|EQUIVALENCE|Pre-defined equivalence margin was \[0.737, 1.357\]|Risk Ratio (RR)|1.11|||||TWO_SIDED|90.0|0.975|1.269|||||SB8 vs. Avastin|||1.269|0.975|
70924755|NCT04648033|141342245|OTHER||Probability of DLT at dose level 4|0.116|||||TWO_SIDED|95.0|0.032|0.26||||||The primary analysis is performed using the Time-To-Event Continual Reassessment Method (TiTE-CRM). Giving posterior estimates for the probability of toxicity (DLT) at each dose level.||0.26|0.032|
70924756|NCT05671029|141342304|NON_INFERIORITY|Null hypothesis: difference to placebo of change from baseline QTcF ≥ 10 ms.|Prediction @ mean max concentration|0.8|||<|0.05|TWO_SIDED|90.0|-1.3|2.9|||Mixed Models Analysis|||||2.9|-1.3|<0.05
70924757|NCT05481216|141342350|OTHER|Unadjusted and adjusted hazard ratios (HR) will be calculated using a proportional Cox regression model. The adjusted variables were body mass index (BMI), dementia, peripheral vascular disease, history of pneumonia, connective tissue disease, liver disease, diabetes, chronic kidney disease, glucocorticoids, hydroxychloroquine, tocilizumab, and anti-IL6 inhibitors.|Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.73|2.29||||||||2.29|0.73|
70924758|NCT05481216|141342350|OTHER||Adjusted Hazard Ratio|1.3|||||TWO_SIDED|95.0|0.73|2.29||||||The adjusted variables were body mass index (BMI), dementia, peripheral vascular disease, history of pneumonia, connective tissue disease, liver disease, diabetes, chronic kidney disease, glucocorticoids, hydroxychloroquine, tocilizumab, and anti-IL6 inhibitors.||2.29|0.73|
70924759|NCT05481216|141342354|OTHER|||||||0.009|||||||Regression, Logistic|||Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19.||||0.009
70924760|NCT05481216|141342375|OTHER||Odds Ratio (OR)|0.85||||0.033|TWO_SIDED|95.0|0.74|0.99|||Regression, Logistic|||Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculated||0.99|0.74|0.033
70924761|NCT05481216|141342376|OTHER||Odds Ratio (OR)|1.93||||0.012|TWO_SIDED|95.0|1.16|3.22|||Regression, Logistic|||Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculated||3.22|1.16|0.012
70924762|NCT05481216|141342377|OTHER||Odds Ratio (OR)|0.99||||0.458|TWO_SIDED|95.0|0.95|1.02|||Regression, Logistic|||Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculated||1.02|0.95|0.458
70924763|NCT05481216|141342378|OTHER||Odds Ratio (OR)|2.71|||<|0.001|TWO_SIDED|95.0|1.61|4.57|||Regression, Logistic|||Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculated||4.57|1.61|<0.001
70924764|NCT05481216|141342379|OTHER||Odds Ratio (OR)|1.74|||<|0.001|TWO_SIDED|95.0|1.34|2.25|||Regression, Logistic|||Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculated||2.25|1.34|<0.001
70924765|NCT04649359|141342385|OTHER||||||<|0.0001|||||||Exact binominal|||Null hypothesis of ORR by BICR for cohort A was 30%.||||<0.0001
70924766|NCT04649359|141342385|OTHER||||||<|0.0001|||||||Exact binominal|||Null hypothesis of ORR by BICR for cohort B was 15%.||||<0.0001
70924767|NCT04649359|141342386|OTHER||||||<|0.0001|||||||Exact binominal|||Null hypothesis of ORR by BICR for cohort A was 12%.||||<0.0001
70924768|NCT04649359|141342387|OTHER||||||<|0.0001|||||||Exact binominal|||Null hypothesis of ORR by BICR for cohort A was 38%.||||<0.0001
71044012|NCT00107042|141597469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.4646|TWO_SIDED|95.0|0.36|9.36|||Univariate regression, logistic||The reference group is the '15-17 year' age group|||9.36|0.36|0.4646
70924769|NCT02243709|141342407|OTHER||||||>|0.05|||||||Chi-squared|||||||>.05
70924770|NCT03443323|141342424|SUPERIORITY||||||<|0.001||||||Statistical significance was evaluated using a threshold p value of .0083, accounting for the estimation of three contrasts of time-by-treatment differences per outcome and two measures per domain (OTMP skills \[COSS-P, COSS-T\]).|Mixed Models Analysis|||||||<.001
70924771|NCT03443323|141342425|SUPERIORITY||||||<|0.001||||||Statistical significance was evaluated using a threshold p value of .0083, accounting for the estimation of three contrasts of time-by-treatment differences per outcome and two measures per domain (OTMP skills \[COSS-P, COSS-T\]).|Mixed Models Analysis|||||||<.001
70924772|NCT03443323|141342426|SUPERIORITY|||||||0.007||||||Statistical significance was evaluated using a threshold p value of .0083, accounting for the estimation of three contrasts of time-by-treatment differences per outcome and two measures per domain (homework performance \[HPC, HPQ-T\]).|Mixed Models Analysis|||||||0.007
71004546|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-6.41||||0.503||95.0||||p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.5030
71044013|NCT00107042|141597470|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.45||||0.339|TWO_SIDED|95.0|0.09|2.3|||Univariate regression, logistic||The reference group is the 'Female' group.|||2.30|0.09|0.3390
71044014|NCT00107042|141597471|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.86||||0.0102|TWO_SIDED|95.0|1.58|29.78|||Univariate regression, logistic||The reference group is the 'Hispanic: NO' group.|||29.78|1.58|0.0102
71004547|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-12.49||||0.1938||95.0||||p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.1938
71004548|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-33.13||||0.0003||95.0||||p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0003
71044015|NCT00107042|141597471|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.38||||0.0118|TWO_SIDED|95.0|1.56|34.95||Since Hispanic (no, yes) was a factor with a p-value of \< 0.15 in the unadjusted univariate regression analysis, it was entered into the initial full multivariate model.|Multivariate regression, logistic||"The reference group is the Hispanic: NO group."|||34.95|1.56|0.0118
70924773|NCT03443323|141342427|SUPERIORITY||||||<|0.001||||||Statistical significance was evaluated using a threshold p value of .0083, accounting for the estimation of three contrasts of time-by-treatment differences per outcome and two measures per domain (homework performance \[HPC, HPQ-T\]).|Mixed Models Analysis|||||||<.001
70924774|NCT03443323|141342428|SUPERIORITY||||||<|0.06||||||Statistical significance was evaluated using a threshold p value of .0083, accounting for the estimation of three contrasts of time-by-treatment differences per outcome and two measures per domain (academic performance \[ACES, APS\]).|Mixed Models Analysis|||||||<.06
70924775|NCT03443323|141342429|SUPERIORITY||||||>|0.0083||||||Statistical significance was evaluated using a threshold p value of .0083, accounting for the estimation of three contrasts of time-by-treatment differences per outcome and two measures per domain (academic performance \[ACES, APS\]).|Mixed Models Analysis|||||||>.0083
70924776|NCT03443323|141342430|SUPERIORITY||||||>|0.05||||||Statistical significance was evaluated using a threshold p value of .05.|Mixed Models Analysis|||||||>.05
70924777|NCT03443323|141342431|SUPERIORITY||||||>|0.05||||||Statistical significance was evaluated using a threshold p value of .05.|Mixed Models Analysis|||||||>.05
70924778|NCT04610892|141342432|SUPERIORITY||Least Square Mean difference|-8.3797||||0.065||90.0|-17.498|0.7387||One-sided p-value|ANCOVA|The treatment as a fixed effects and the baseline value and the geographic region and statin therapy intensity at screening as covariates.||||0.7387|-17.4980|0.065
70924779|NCT04610892|141342432|SUPERIORITY||Least Square Mean difference|2.3915||||0.747||90.0|-3.5338|8.3167||One-sided p-value|ANCOVA|The treatment as a fixed effects and the baseline value and the geographic region and statin therapy intensity at screening as covariates.||||8.3167|-3.5338|0.747
71004549|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-24.66||||0.0101||95.0||||p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0101
71044016|NCT00107042|141597472|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.4241|TWO_SIDED|95.0|0.04|3.84|||Univariate regression, logistic||The reference group is the 'White' group.|||3.84|0.04|0.4241
70924780|NCT04610892|141342432|SUPERIORITY||Least Square Mean difference|0.5766||||0.563||90.0|-5.4389|6.5921||One-sided p-value|ANCOVA|The treatment as a fixed effects and the baseline value and the geographic region and statin therapy intensity at screening as covariates.||||6.5921|-5.4389|0.563
70924781|NCT04610892|141342432|SUPERIORITY||Least Square Mean difference|1.5204||||0.685||90.0|-3.6657|6.7064||One-sided p-value|ANCOVA|The treatment as a fixed effects and the baseline value and the geographic region and statin therapy intensity at screening as covariates.||||6.7064|-3.6657|0.685
70924782|NCT04610892|141342433|SUPERIORITY||Geometric LS mean ratio estimate|1.12||||0.854||90.0|0.94|1.33||One sided p-value|Mixed model with repeated measurements|The model was adjusted for the baseline value and the stratification factors (geographic region and statin therapy intensity at screening).||||1.33|0.94|0.854
70924783|NCT04610892|141342433|SUPERIORITY||Geometric LS mean ratio estimate|1.06||||0.79||90.0|0.94|1.18||One sided p-value|Mixed model with repeated measurements|The model was adjusted for the baseline value and the stratification factors (geographic region and statin therapy intensity at screening).||||1.18|0.94|0.790
70924784|NCT04610892|141342433|SUPERIORITY||Geometric LS mean ratio estimate|1.0||||0.498||90.0|0.89|1.12||One sided p-value|Mixed model with repeated measurements|The model was adjusted for the baseline value and the stratification factors (geographic region and statin therapy intensity at screening).||||1.12|0.89|0.498
70924785|NCT04610892|141342433|SUPERIORITY||Geometric LS mean ratio estimate|1.03||||0.678||90.0|0.93|1.13||One sided p-value|Mixed model with repeated measurements|The model was adjusted for the baseline value and the stratification factors (geographic region and statin therapy intensity at screening).||||1.13|0.93|0.678
70924786|NCT04610892|141342434|SUPERIORITY||Least Squares mean difference|-1.44||||0.99||90.0|-2.44|-0.43||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.43|-2.44|0.990
70924787|NCT04610892|141342434|SUPERIORITY||Least Squares mean difference|-0.21||||0.697||90.0|-0.87|0.45||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||0.45|-0.87|0.697
70924788|NCT04610892|141342434|SUPERIORITY||Least Squares mean difference|-0.42||||0.849||90.0|-1.08|0.25||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||0.25|-1.08|0.849
70924789|NCT04610892|141342434|SUPERIORITY||Least Squares mean difference|-0.31||||0.811||90.0|-0.89|0.27||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||0.27|-0.89|0.811
70924790|NCT04610892|141342435|SUPERIORITY||Least Squares mean difference|-3.5||||0.972||90.0|-6.49|-0.5||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.50|-6.49|0.972
71004550|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-43.47|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
71044017|NCT00107042|141597472|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.12||||0.2685|TWO_SIDED|95.0|0.34|50.76|||Univariate regression, logistic||The reference group is the 'White' group.|||50.76|0.34|0.2685
71101379|NCT01421459|141710786|SUPERIORITY_OR_OTHER|||||||0.186||95.0||||P-value is for HbA1c \<7%% at 24 weeks.|Chi-squared|||||||0.186
70924791|NCT04610892|141342435|SUPERIORITY||Least Squares mean difference|-1.1||||0.777||90.0|-3.49|1.3||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||1.30|-3.49|0.777
70924792|NCT04610892|141342435|SUPERIORITY||Least Squares mean difference|-0.32||||0.596||90.0|-2.54|1.89||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||1.89|-2.54|0.596
71101380|NCT01421459|141710786|SUPERIORITY_OR_OTHER|||||||0.174||95.0||||P-value is for HbA1c ≤6.5% at 24 weeks.|Chi-squared|||||||0.174
71101381|NCT01421459|141710786|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||P-value is for HbA1c \<7% at Endpoint, up to 24 weeks.|Chi-squared|||||||0.340
70924793|NCT04610892|141342435|SUPERIORITY||Least Squares mean difference|-0.63||||0.698||90.0|-2.64|1.38||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||1.38|-2.64|0.698
70924794|NCT04610892|141342436|SUPERIORITY||Least Squares mean difference|-1.29||||0.981||90.0|-2.32|-0.27||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.27|-2.32|0.981
71044018|NCT00107042|141597473|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.939|TWO_SIDED|95.0|0.05|15.44|||Univariate regression, logistic||The reference group is the 'Stage 5' group.|||15.44|0.05|0.9390
71044019|NCT00107042|141597474|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.6181|TWO_SIDED|95.0|0.3|7.39|||Univariate regression, logistic||"The reference group is the Stage 5 group."|||7.39|0.30|0.6181
71044020|NCT00107042|141597475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.1943|TWO_SIDED|95.0|0.1|1.6|||Univariate regression, logistic||"The reference group is the Normal and Underweight (\<25.0) group."|||1.60|0.10|0.1943
70924795|NCT04610892|141342436|SUPERIORITY||Least Squares mean difference|-0.8||||0.974||90.0|-1.47|-0.12||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.12|-1.47|0.974
70924796|NCT04610892|141342436|SUPERIORITY||Least Squares mean difference|-0.86||||0.983||90.0|-1.53|-0.2||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.20|-1.53|0.983
71044021|NCT00107042|141597476|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42||||0.2542|TWO_SIDED|95.0|0.1|1.86|||Univariate regression, logistic||"The reference group is the Ever smoked cigarettes: NO group."|||1.86|0.10|0.2542
71044022|NCT00107042|141597477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.14||||0.0161|TWO_SIDED|95.0|0.03|0.69|||Univariate regression, logistic||"The reference group is the Straight (heterosexual) group."|||0.69|0.03|0.0161
71044023|NCT00107042|141597477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.12||||0.0222|TWO_SIDED|95.0|0.02|0.74||Since sexual identity was a factor with a p-value of \< 0.15 in the unadjusted univariate regression analysis, it was entered into the initial full multivariate model.|Multivariate regression, logistic||"The reference group is the Straight (heterosexual) group."|||0.74|0.02|0.0222
70924797|NCT04610892|141342436|SUPERIORITY||Least Squares mean difference|-0.83||||0.99||90.0|-1.42|-0.25||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.25|-1.42|0.990
70924798|NCT04610892|141342437|SUPERIORITY||Least Squares mean difference|-2.14||||0.959||90.0|-4.16|-0.12||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.12|-4.16|0.959
70924799|NCT04610892|141342437|SUPERIORITY||Least Squares mean difference|-2.92||||0.998||90.0|-4.53|-1.31||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-1.31|-4.53|0.998
70924800|NCT04610892|141342437|SUPERIORITY||Least Squares mean difference|-1.35||||0.939||90.0|-2.79|0.09||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||0.09|-2.79|0.939
70924801|NCT04610892|141342437|SUPERIORITY||Least Squares mean difference|-1.94||||0.991||90.0|-3.27|-0.62||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.62|-3.27|0.991
71044024|NCT00107042|141597478|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.8945|TWO_SIDED|95.0|0.12|11.83|||Univariate regression, logistic||"The reference group is the Never (had sex)group."|||11.83|0.12|0.8945
70924802|NCT04610892|141342438|SUPERIORITY||Least Squares mean difference|-16.137||||0.077||90.0|-34.7829|2.5089||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||2.5089|-34.7829|0.077
70924803|NCT04610892|141342438|SUPERIORITY||Least Squares mean difference|-0.5927||||0.468||90.0|-12.7267|11.5413||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||11.5413|-12.7267|0.468
70924804|NCT04610892|141342438|SUPERIORITY||Least Squares mean difference|-0.1767||||0.491||90.0|-12.4678|12.1144||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||12.1144|-12.4678|0.491
70924805|NCT04610892|141342438|SUPERIORITY||Least Squares mean difference|-0.393||||0.476||90.0|-11.0022|10.2162||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||10.2162|-11.0022|0.476
70924806|NCT04610892|141342439|SUPERIORITY||Least Squares mean difference|-4.3435||||0.136||90.0|-10.8637|2.1768||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||2.1768|-10.8637|0.136
70924807|NCT04610892|141342439|SUPERIORITY||Least Squares mean difference|-1.2369||||0.316||90.0|-5.4796|3.0059||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||3.0059|-5.4796|0.316
70924808|NCT04610892|141342439|SUPERIORITY||Least Squares mean difference|-0.7015||||0.394||90.0|-5.0096|3.6065||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||3.6065|-5.0096|0.394
70924809|NCT04610892|141342439|SUPERIORITY||Least Squares mean difference|-0.9799||||0.332||90.0|-4.6927|2.7329||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||2.7329|-4.6927|0.332
70924810|NCT03683719|141342448|SUPERIORITY||||||<|0.001||||||"P-values were adjusted for multiple comparisons. Models with an adjusted p-value \<0.025 were statistically sign. different from a flat dose-response model. Model: IGA-CHE TS = Treatment + Region + Baseline IGA-CHE.~Model selected: Emax model"|Multiple contrast test|||The primary endpoint was evaluated by determining if there was a dose-response relationship between the IGA-CHE response rate at Week 16 and the dose administered, using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed and multiple comparison techniques were used to choose the model(s) most likely to represent the true underlying dose-response curve.||||<0.001
70924811|NCT03683719|141342448|SUPERIORITY||Risk Difference (RD)|13.29|||>|0.05|TWO_SIDED|95.0|0.34|26.24||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue medication before Week 16 were considered missing and imputed as non-responders (as were any other missing data).|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline IGA-CHE score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative that there is a difference.||26.24|0.34|>0.05
70924812|NCT03683719|141342448|SUPERIORITY||Risk Difference (RD)|-0.03|||>|0.05|TWO_SIDED|95.0|-10.44|10.39||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue medication before Week 16 were considered missing and imputed as non-responders (as were any other missing data).|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline IGA-CHE score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative that there is a difference.||10.39|-10.44|>0.05
71004551|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-24.69||||0.006||95.0||||p-value represents change from baseline to Week 12 for prior to dinner glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0060
71004552|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-34.26||||0.0002||95.0||||p-value represents change from baseline to Week 12 for prior to dinner glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0002
71004553|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-38.55|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to dinner glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
71004554|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-40.34|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to dinner glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
71004555|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-46.26|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to dinner glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
71004556|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-11.84||||0.2468||95.0||||p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.2468
71004557|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-21.13||||0.0413||95.0||||p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, visit, treatment and visit by treatment interaction as fixed effects||||||0.0413
71004558|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-35.19||||0.0004||95.0||||p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0004
71004559|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-29.59||||0.004||95.0||||p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0040
71004560|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-49.9|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
71004561|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-24.02||||0.0199||95.0||||p-value represents change from baseline to Week 12 for prior to bed glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0199
71004562|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-35.77||||0.0008||95.0||||p-value represents change from baseline to Week 12 for prior to bed glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0008
71044025|NCT00107042|141597478|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.12||||0.019|TWO_SIDED|95.0|0.02|0.7|||Univariate regression, logistic||"The reference group is the Never (had sex) group."|||0.70|0.02|0.0190
71044026|NCT00107042|141597479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.08||||0.0042|TWO_SIDED|95.0|0.01|0.48|||Univariate regression, logistic||"The reference group is the 0 partners group"|||0.48|0.01|0.0042
71004563|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-38.17||||0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to bed glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0001
71044027|NCT00107042|141597479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.6893||95.0|||||Univariate regression, Logistic||"The reference group is the 0 partners group.~Two sided 95% confidence interval: Lower Limit = 0.17; upper limit = infinity"|||||0.6893
71004564|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-40.74||||0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to bed glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0001
71004565|NCT00804986|141517300|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-53.16|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to bed glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
71044028|NCT00107042|141597480|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.015||||0.0003|TWO_SIDED|95.0|0.0|0.19|||Univariate regression, logistic||"The reference group is hte 0 Partners group."|||0.19|0.00|0.0003
70924813|NCT03683719|141342448|SUPERIORITY||Risk Difference (RD)|28.22|||<|0.001|TWO_SIDED|95.0|13.8|42.64||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue medication before Week 16 were considered missing and imputed as non-responders (as were any other missing data).|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline IGA-CHE score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative that there is a difference.||42.64|13.8|<0.001
70924814|NCT03683719|141342448|SUPERIORITY||Risk Difference (RD)|29.61|||<|0.001|TWO_SIDED|95.0|14.56|44.67||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue medication before Week 16 were considered missing and imputed as non-responders (as were any other missing data).|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline IGA-CHE score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative that there is a difference.||44.67|14.56|<0.001
70924815|NCT03683719|141342449|SUPERIORITY||||||<|0.0001||||||"P-values were adjusted for multiple comparisons. Models with an adj. p-value \<0.025 were statistically sign. different from a flat dose-response model. Model: Change = Treatment + Baseline + Region + Baseline IGA-CHE.~Model selected: Emax model"|Multiple contrast test|||"The secondary endpoint Change from baseline to Week 16 in HECSI score was evaluated by determining if there was a dose-response relationship between the change from baseline in HECSI score at Week 16 and the dose administered, using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed and multiple comparison techniques were used to choose the model(s) most likely to represent the true underlying dose-response curve."||||<0.0001
70924816|NCT03683719|141342449|SUPERIORITY||Mean Difference (Net)|-13.41|||<|0.01|TWO_SIDED|95.0|-22.82|-4.01||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. before Week 16 were considered missing and imputed with MMRM predicted values (as were any other missing data).|Mixed Models Analysis|||"Least Square (LS) Means were calculated using a mixed model for repeated measurements on the post-baseline responses up to Week 16 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom, and the mean modelled as follows:~Change from baseline in HECSI~= treatment × visit + baseline HECSI × visit + region + baseline IGA-CHE.~The primary comparison between each active delgocitinib dose and vehicle was at Week 16."||-4.01|-22.82|<0.01
70924817|NCT03683719|141342449|SUPERIORITY||Mean Difference (Net)|-9.53|||<|0.05|TWO_SIDED|95.0|-19.04|-0.02||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. before Week 16 were considered missing and imputed with MMRM predicted values (as were any other missing data).|Mixed Models Analysis|||"Least Square (LS) Means were calculated using a mixed model for repeated measurements on the post-baseline responses up to Week 16 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom, and the mean modelled as follows:~Change from baseline in HECSI~= treatment × visit + baseline HECSI × visit + region + baseline IGA-CHE.~The primary comparison between each active delgocitinib dose and vehicle was at Week 16."||-0.02|-19.04|<0.05
70924818|NCT03683719|141342449|SUPERIORITY||Mean Difference (Net)|-20.29|||<|0.0001|TWO_SIDED|95.0|-29.56|-11.02||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. before Week 16 were considered missing and imputed with MMRM predicted values (as were any other missing data).|Mixed Models Analysis|||"Least Square (LS) Means were calculated using a mixed model for repeated measurements on the post-baseline responses up to Week 16 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom, and the mean modelled as follows:~Change from baseline in HECSI~= treatment × visit + baseline HECSI × visit + region + baseline IGA-CHE.~The primary comparison between each active delgocitinib dose and vehicle was at Week 16."||-11.02|-29.56|<0.0001
70924819|NCT03683719|141342449|SUPERIORITY||Mean Difference (Net)|-15.59|||<|0.01|TWO_SIDED|95.0|-24.82|-6.36||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. before Week 16 were considered missing and imputed with MMRM predicted values (as were any other missing data).|Mixed Models Analysis|||"Least Square (LS) Means were calculated using a mixed model for repeated measurements on the post-baseline responses up to Week 16 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom, and the mean modelled as follows:~Change from baseline in HECSI~= treatment × visit + baseline HECSI × visit + region + baseline IGA-CHE.~The primary comparison between each active delgocitinib dose and vehicle was at Week 16."||-6.36|-24.82|<0.01
70924820|NCT03683719|141342450|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline IGA-CHE score. An event was defined as the first time achieving IGA-CHE TS.|||||<|0.05||||||"IGA-CHE TS was reached in less than 50% of participants, therefore the median time was not estimable.~The statistical test was not controlled for multiplicity."|Log Rank|||Time to IGA-CHE TS was defined as the time from the date of the first IMP application to first assessment of IGA-CHE TS. Subjects without baseline observation were censored at the date of the first IMP application. Subjects with baseline observation not achieving IGA-CHE TS during the treatment period were censored at the date of the last visit with a valid post-baseline assessment on or prior to the date of discontinuation of IMP or initiation of rescue medication, whichever occurred first.||||<0.05
71004566|NCT00804986|141517301|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-1131.85||||0.4193||95.0||||p-value represents change from baseline to Week 12 total glucose AUC for 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.4193
71101382|NCT01421459|141710786|SUPERIORITY_OR_OTHER|||||||0.293||95.0||||P-value is for HbA1c ≤6.5% at Endpoint, up to 24 weeks.|Chi-squared|||||||0.293
70924821|NCT03683719|141342450|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline IGA-CHE score. An event was defined as the first time achieving IGA-CHE TS.|||||>|0.1||||||"IGA-CHE TS was reached in less than 50% of participants, therefore the median time was not estimable.~The statistical test was not controlled for multiplicity."|Log Rank|||Time to IGA-CHE TS was defined as the time from the date of the first IMP application to first assessment of IGA-CHE TS. Subjects without baseline observation were censored at the date of the first IMP application. Subjects with baseline observation not achieving IGA-CHE TS during the treatment period were censored at the date of the last visit with a valid post-baseline assessment on or prior to the date of discontinuation of IMP or initiation of rescue medication, whichever occurred first.||||>0.1
71004567|NCT00804986|141517301|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-1471.04||||0.3026||95.0||||p-value represents change from baseline to Week 12 total glucose AUC for 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.3026
71004568|NCT00804986|141517301|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-5547.95|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 total glucose AUC for 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
71004569|NCT00804986|141517301|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-6116.19|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 total glucose AUC for 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
71004570|NCT00804986|141517301|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-7786.69|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 total glucose AUC for 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
71004571|NCT00804986|141517304|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|0.08||||0.693||95.0||||p-value represents change from baseline to Week 12 for fasting triglycerides, 0.5 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.693
71004572|NCT00804986|141517304|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|0.31||||0.104||95.0||||p-value represents change from baseline to Week 12 for fasting triglycerides, 2.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.104
71004573|NCT00804986|141517304|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.13||||0.506||95.0||||p-value represents change from baseline to Week 12 for fasting triglycerides, 6.2 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.506
71004574|NCT00804986|141517304|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.09||||0.648||95.0||||p-value represents change from baseline to Week 12 for fasting triglycerides, 12.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.648
71044029|NCT00107042|141597480|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||1|TWO_SIDED|95.0|0.0|10.01|||Univariate regression, Logistic||"The reference group is the 0 Partners group"|||10.01|0.00|1.0000
71044030|NCT00107042|141597481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5||||0.5503|TWO_SIDED|95.0|0.05|4.86|||Univariate regression, logistic||"The reference group is the 0 Partners group"|||4.86|0.05|0.5503
71101383|NCT01421459|141710787|SUPERIORITY_OR_OTHER|||||||0.594||95.0||||P-value is for Total Hypoglycemic with BG ≤70 mg/dL events.|Chi-squared|||||||0.594
71004575|NCT00804986|141517304|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.09||||0.647||95.0||||p-value represents change from baseline to Week 12 for fasting triglycerides, 17.6 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.647
71004576|NCT00804986|141517304|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|0.01||||0.781||95.0||||p-value represents change from baseline to Week 12 for fasting HDL, 0.5 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.781
71004577|NCT00804986|141517304|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.04||||0.401||95.0||||p-value represents change from baseline to Week 12 for fasting HDL, 2.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.401
71044031|NCT00107042|141597481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.8904|TWO_SIDED|95.0|0.13|10.46|||Univariate Regression, Logistic||"The reference group is the 0 Partners group."|||10.46|0.13|0.8904
71004578|NCT00804986|141517304|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.03||||0.464||95.0||||p-value represents change from baseline to Week 12 for fasting HDL, 6.2 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.464
71004579|NCT00804986|141517304|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.04||||0.42||95.0||||p-value represents change from baseline to Week 12 for fasting HDL, 12.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.420
71044032|NCT00107042|141597482|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48||||0.301|TWO_SIDED|95.0|0.12|1.92|||Univariate regression, logistic||"The reference group is the Ever drank alcohol: NO group."|||1.92|0.12|0.3010
71101384|NCT01421459|141710787|SUPERIORITY_OR_OTHER|||||||0.462||95.0||||P-value is for Nocturnal Hypoglycemic with BG ≤70 mg/dL events.|Chi-squared|||||||0.462
71101385|NCT01421459|141710788|SUPERIORITY_OR_OTHER|||||||0.995||95.0||||P-value is for Total Hypoglycemia with BG ≤70 mg/dL events.|Wilcoxon (Mann-Whitney)|||||||0.995
71101386|NCT01421459|141710788|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||P-value is for Nocturnal Hypoglycemia with BG ≤70 mg/dL events.|Wilcoxon (Mann-Whitney)|||||||0.686
71101387|NCT01421459|141710789|SUPERIORITY_OR_OTHER|||||||0.285||95.0||||P-value is for Baseline.|Chi-squared|||||||0.285
71101388|NCT01421459|141710789|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-value is for 4 weeks.|Chi-squared|||||||0.047
71101389|NCT01421459|141710789|SUPERIORITY_OR_OTHER|||||||0.882||95.0||||P-value is for 12 weeks.|Chi-squared|||||||0.882
71101390|NCT01421459|141710789|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||P-value is for 24 weeks.|Chi-squared|||||||0.179
71101391|NCT01421459|141710789|SUPERIORITY_OR_OTHER|||||||0.314||95.0||||P-value is for Endpoint, up to 24 weeks.|Chi-squared|||||||0.314
70924822|NCT03683719|141342450|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline IGA-CHE score. An event was defined as the first time achieving IGA-CHE TS.|||||<|0.0001||||||The statistical test was not controlled for multiplicity.|Log Rank|||Time to IGA-CHE TS was defined as the time from the date of the first IMP application to first assessment of IGA-CHE TS. Subjects without baseline observation were censored at the date of the first IMP application. Subjects with baseline observation not achieving IGA-CHE TS during the treatment period were censored at the date of the last visit with a valid post-baseline assessment on or prior to the date of discontinuation of IMP or initiation of rescue medication, whichever occurred first.||||<0.0001
70924823|NCT03683719|141342450|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline IGA-CHE score. An event was defined as the first time achieving IGA-CHE TS.|||||<|0.01||||||The statistical test was not controlled for multiplicity.|Log Rank|||Time to IGA-CHE TS was defined as the time from the date of the first IMP application to first assessment of IGA-CHE TS. Subjects without baseline observation were censored at the date of the first IMP application. Subjects with baseline observation not achieving IGA-CHE TS during the treatment period were censored at the date of the last visit with a valid post-baseline assessment on or prior to the date of discontinuation of IMP or initiation of rescue medication, whichever occurred first.||||<0.01
70924824|NCT03135548|141342481|OTHER|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|0.078|||||TWO_SIDED|95.0|-0.19|0.338|||Wilson/Newcombe|95% confidence intervals (CI) are calculated using the method of Wilson/Newcombe.|Unadjusted absolute risk difference versus placebo was calculated as the difference in the observed proportion of patients with ppPASI50 at Week 16 for each treatment scenario, for the FAS.|||0.338|-0.190|
70924825|NCT03135548|141342481|OTHER|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|0.078|||||TWO_SIDED|95.0|-0.19|0.338|||Wilson/Newcombe|95% CIs are calculated using the method of Wilson/Newcombe.|Unadjusted absolute risk difference versus placebo was calculated as the difference in the observed proportion of patients with ppPASI50 at Week 16 for each treatment scenario, for the FAS.|||0.338|-0.190|
70924826|NCT03135548|141342483|OTHER|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|-0.095|||||TWO_SIDED|95.0|-0.289|0.086|||Wilson/Newcombe|95% CIs are calculated using the method of Wilson/Newcombe.|Unadjusted absolute risk difference versus placebo was calculated as the difference in the observed proportion of patients with ppPASI50 at Week 16 for each treatment scenario, for the FAS.|||0.086|-0.289|
70924827|NCT03135548|141342483|OTHER|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|0.115|||||TWO_SIDED|95.0|-0.116|0.348|||Wilson/Newcombe|95% CIs are calculated using the method of Wilson/Newcombe.|Unadjusted absolute risk difference versus placebo was calculated as the difference in the observed proportion of patients with ppPASI50 at Week 16 for each treatment scenario, for the FAS.|||0.348|-0.116|
70924828|NCT03135548|141342484|OTHER|No formal hypothesis testing was performed in this trial.|Mean Difference (Final Values)|7.24|||||TWO_SIDED|95.0|-20.01|34.48|||Student's t-distribution|CIs were based on Student's t-distribution.||||34.48|-20.01|
70924829|NCT03135548|141342484|OTHER|No formal hypothesis testing was performed in this trial.|Mean Difference (Final Values)|-5.82|||||TWO_SIDED|95.0|-28.35|16.7|||Student's t-distribution|CIs were based on Student's t-distribution.||||16.70|-28.35|
70924830|NCT03135548|141342485|OTHER|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|-0.143|||||TWO_SIDED|95.0|-0.346|0.049|||Wilson/Newcombe|95% CIs are calculated using the method of Wilson/Newcombe.||||0.049|-0.346|
70924831|NCT03135548|141342485|OTHER|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|0.015|||||TWO_SIDED|95.0|-0.213|0.252|||Wilson/Newcombe|95% CIs are calculated using the method of Wilson/Newcombe.||||0.252|-0.213|
71004580|NCT00804986|141517304|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|0.01||||0.762||95.0||||p-value represents change from baseline to Week 12 for fasting HDL, 17.6 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.762
71101392|NCT01421459|141710789|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||P-value is for Baseline to 24 weeks (Overall).|Chi-squared|||||||0.100
71101393|NCT01421459|141710790|SUPERIORITY_OR_OTHER|||||||0.176||95.0||||P-value is for 4 weeks.|Chi-squared|||||||0.176
71101394|NCT01421459|141710790|SUPERIORITY_OR_OTHER|||||||0.999||95.0||||P-value is for 12 weeks.|Chi-squared|||||||0.999
71101395|NCT01421459|141710790|SUPERIORITY_OR_OTHER|||||||0.618||95.0||||P-value is for 24 weeks.|Chi-squared|||||||0.618
71101396|NCT01421459|141710790|SUPERIORITY_OR_OTHER|||||||0.874||95.0||||P-value is for Endpoint (LOCF).|Chi-squared|||||||0.874
71101397|NCT01421459|141710790|SUPERIORITY_OR_OTHER||||||>|0.233||95.0||||P-value is for Overall (Baseline to 24 weeks).|Chi-squared|||||||>0.233
71101398|NCT04439903|141710798|OTHER||Intercept|1.9726|STANDARD_ERROR_OF_MEAN|3.8238||0.61532|TWO_SIDED||||||Regression, Linear|||||||0.61532
71101399|NCT04439903|141710798|OTHER||Slope|-0.68016|STANDARD_ERROR_OF_MEAN|1.0084||0.5128|TWO_SIDED||||||Regression, Linear||Predictor variable 1: Number of simulations per participant per week.|||||0.5128
71101400|NCT04439903|141710798|OTHER||Slope|0.15238|STANDARD_ERROR_OF_MEAN|0.3629||0.68197|TWO_SIDED||||||Regression, Linear||Predictor variable 2: Minutes of interaction with the Web-Based Simulation Tool per participant per week.|||||0.68197
71101401|NCT04439903|141710799|OTHER||Intercept|-0.49527|STANDARD_ERROR_OF_MEAN|0.44535||0.28789|TWO_SIDED||||||Regression, Linear|||||||0.28789
71101402|NCT04439903|141710799|OTHER||Slope|0.16785|STANDARD_ERROR_OF_MEAN|0.11745||0.17848|TWO_SIDED||||||Regression, Linear||Predictor variable 1: Number of simulations per participant per week.|||||0.17848
70924832|NCT03924986|141342486|OTHER||Hazard Ratio (HR)|0.52|||||TWO_SIDED|95.0|0.38|0.73|||||Estimated using a Cox proportional hazards model with Efron's method for tied events, with Arm B as the reference group. The analysis was stratified by gender and liver metastases status.|The null hypothesis to be tested is that progression-free survival (PFS) in Arm A is less than or equal to PFS in Arm B. This is compared against the alternative hypothesis, which posits that PFS in Arm A is greater than PFS in Arm B.||0.73|0.38|
70924833|NCT03924986|141342487|OTHER||Odds Ratio (OR)|1.85|||||TWO_SIDED|95.0|1.11|3.07|||||||Arm B was the reference group, and the odds ratio between arms was calculated using the Cochran-Mantel-Haenszel chi-square test, stratified by gender and liver metastases status.|3.07|1.11|
70924834|NCT03924986|141342489|OTHER||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.51|1.05|||||Estimated using a Cox proportional hazards model with Efron's method for tied events, with Arm B as the reference group. The analysis was stratified by gender and liver metastases status.|||1.05|0.51|
70924835|NCT03924986|141342490|OTHER||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.38|0.76|||||Estimated using a Cox proportional hazards model with Efron's method for tied events, with Arm B as the reference group. The analysis was stratified by gender and liver metastases status.|The null hypothesis to be tested is that progression-free survival (PFS) in Arm A is less than or equal to PFS in Arm B. This is compared against the alternative hypothesis, which posits that PFS in Arm A is greater than PFS in Arm B.||0.76|0.38|
70924836|NCT05592418|141342551|SUPERIORITY||Mean Difference (Final Values)|0.0288||||0.9851|TWO_SIDED|95.0|-3.0397|3.0972|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|||3.0972|-3.0397|0.9851
70924837|NCT05592418|141342552|SUPERIORITY||Mean Difference (Final Values)|-1.9076||||0.3095|TWO_SIDED|95.0|-5.6279|1.8128|||ANCOVA|||||1.8128|-5.6279|0.3095
70924838|NCT05592418|141342553|SUPERIORITY||Mean Difference (Final Values)|0.6086||||0.7663|TWO_SIDED|95.0|-3.4656|4.6829|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|||4.6829|-3.4656|0.7663
70924839|NCT05592418|141342554|SUPERIORITY||Mean Difference (Final Values)|23.7749||||0.3162|TWO_SIDED|95.0|-23.2463|70.7962|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|||70.7962|-23.2463|0.3162
71044033|NCT00107042|141597483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.24||||0.0501|TWO_SIDED|95.0|0.06|1.0|||Univariate regression, logistic||"The reference group is the Ever smoked marijuana: NO group."|||1.00|0.06|0.0501
71044034|NCT00107042|141597484|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.3846|TWO_SIDED|95.0|0.04|3.61|||Univariate regression, logistic||"The reference group is the Ever used drugs not prescribed: NO group."|||3.61|0.04|0.3846
70924840|NCT05592418|141342555|SUPERIORITY|||||||||||||||||P-value is from The Cochran-Mantel-Haenszel test (CMH) stratified by stratification factors|Since all patients analyzed achieved MCID, there are no comparison results|||
70924841|NCT05592418|141342556|SUPERIORITY||Mean Difference (Final Values)|-3.2342||||0.4232|TWO_SIDED|95.0|-11.2586|4.7901|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|||4.7901|-11.2586|0.4232
70924842|NCT05592418|141342557|SUPERIORITY||Mean Difference (Final Values)|-0.5161||||0.7823|TWO_SIDED|95.0|-4.2356|3.2035|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|||3.2035|-4.2356|0.7823
70924843|NCT05592418|141342559|SUPERIORITY||Mean Difference (Final Values)|0.2779||||0.5185|TWO_SIDED|95.0|-0.5775|1.1333|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo.|||1.1333|-0.5775|0.5185
70924844|NCT05592418|141342560|OTHER||||||||||||||||||No patients were hospitalized.|||
71004581|NCT00804986|141517304|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.04||||0.738||95.0||||p-value represents change from baseline to Week 12 for fasting LDL, 0.5 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.738
71004582|NCT00804986|141517304|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.14||||0.277||95.0||||p-value represents change from baseline to Week 12 for fasting LDL, 2.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.277
71044035|NCT00107042|141597485|SUPERIORITY_OR_OTHER|||||||0.3827||95.0|||||Fisher Exact|||||||0.3827
71044036|NCT00107042|141597485|SUPERIORITY_OR_OTHER||Responding Rate|81.08|||||TWO_SIDED|95.0|68.84|92.04|||||Response rate=Total number subjects responded/Total number subjects in arm|||92.04|68.84|
71004583|NCT00804986|141517304|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.21||||0.094||95.0||||p-value represents change from baseline to Week 12 for fasting LDL, 6.2 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.094
71004584|NCT00804986|141517304|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.04||||0.792||95.0||||p-value represents change from baseline to Week 12 for fasting LDL, 12.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.792
71044037|NCT00107042|141597485|SUPERIORITY_OR_OTHER||Responding Rate|88.0|||||TWO_SIDED|95.0|75.69|95.47|||||Response rate=Total number subjects responded/Total number subjects in arm|||95.47|75.69|
70924845|NCT05592418|141342562|SUPERIORITY||Mean Difference (Final Values)|169.389||||0.2175|TWO_SIDED|95.0|-105.892|444.6702|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo.|444.6702|-105.892|0.2175
70924846|NCT05592418|141342563|SUPERIORITY||Mean Difference (Final Values)|-56.9984||||0.2086|TWO_SIDED|95.0|-147.021|33.0241|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|33.0241|-147.021|0.2086
70924847|NCT05592418|141342564|SUPERIORITY||Mean Difference (Final Values)|0.1733||||0.0975|TWO_SIDED|95.0|-0.0327|0.3792|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|0.3792|-0.0327|0.0975
70924848|NCT05592418|141342566|SUPERIORITY||Mean Difference (Final Values)|20.7131||||0.4545|TWO_SIDED|95.0|-34.4079|75.8341|||ANCOVA||LS Mean Difference - LS Mean of Ampligen® - LS Mean of Placebo|||75.8341|-34.4079|0.4545
70924849|NCT05592418|141342567|SUPERIORITY||Mean Difference (Final Values)|44.1231||||0.0333|TWO_SIDED|95.0|4.6338|83.6123|||ANCOVA||LS Mean Difference - LS Mean of Ampligen® - LS Mean of Placebo|||83.6123|4.6338|0.0333
71004585|NCT00804986|141517304|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.21||||0.105||95.0||||p-value represents change from baseline to Week 12 for fasting LDL, 17.6 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.105
71004586|NCT00804986|141517304|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.12||||0.403||95.0||||p-value represents change from baseline to Week 12 for fasting total cholesterol, 0.5 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.403
70924850|NCT03665597|141342583|OTHER|Geometric Least-Square Mean Ratio (GMR) = GM of Pembrolizumab 130 mg/mL SC/GM of Pembrolizumab 200 mg IV|GMR|0.73|||||TWO_SIDED|90.0|0.68|0.78||||||||0.78|0.68|
70924851|NCT03665597|141342583|OTHER|GMR = GM of Pembrolizumab 165 mg/mL SC/GM of Pembrolizumab 200 mg IV|GMR|0.69|||||TWO_SIDED|90.0|0.64|0.74||||||||0.74|0.64|
70924852|NCT03665597|141342584|OTHER|GMR = GM of Pembrolizumab 130 mg/mL SC/GM of Pembrolizumab 200 mg IV|Geometric Least-Square Mean Ratio|0.4|||||TWO_SIDED|90.0|0.36|0.44||||||||0.44|0.36|
70924853|NCT03665597|141342584|OTHER|GMR = GM of Pembrolizumab 165 mg/mL SC/GM of Pembrolizumab 200 mg IV|Geometric Least-Square Mean Ratio|0.38|||||TWO_SIDED|90.0|0.34|0.41||||||||0.41|0.34|
70924854|NCT05260684|141342606|OTHER||Hazard Ratio (HR)|1.32||||0.02|TWO_SIDED|95.0|1.05|1.65|||Wald Chi- Square Statistic||HR was estimated using multivariable Cox proportional hazard models.|Statistical analysis data is presented for Dabrafenib+Trametinib relative to Encorafenib+Binimetinib (reference).||1.65|1.05|0.02
70924855|NCT05260684|141342606|OTHER||Hazard Ratio (HR)|1.17||||0.47|TWO_SIDED|95.0|0.76|1.79|||Wald Chi- Square Statistic||HR was estimated using multivariable Cox proportional hazard models.|Statistical analysis data is presented for Vemurafenib + Cobimetinib relative to Encorafenib+Binimetinib (reference).||1.79|0.76|0.47
70924856|NCT05260684|141342607|OTHER||Hazard Ratio (HR)|1.49|||<|0.001|TWO_SIDED|95.0|1.2|1.87|||Wald Chi- Square Statistic||HR was estimated using multivariable Cox proportional hazard models.|Statistical analysis data is presented for Dabrafenib+Trametinib relative to Encorafenib+Binimetinib (reference).||1.87|1.20|<0.001
70924857|NCT05260684|141342607|OTHER||Hazard Ratio (HR)|1.2||||0.4|TWO_SIDED|95.0|0.79|1.82|||Wald Chi- Square Statistic||HR was estimated using multivariable Cox proportional hazard models.|Statistical analysis data is presented for Vemurafenib + Cobimetinib relative to Encorafenib+Binimetinib (reference).||1.82|0.79|0.40
70924858|NCT03519581|141342621|OTHER|The primary statistical analysis was an intention-to-treat analysis. The primary outcome was analyzed by Kruskal-Wallis test because the data was non-parametric.||||||0.76|||||||Kruskal-Wallis|||The target sample size for the study was 30 eyes, based on power calculations to achieve 80% power assuming 40% of sham-treated eyes will reach the vision loss threshold within 2 years, while SML treatment will reduce that value to 15%, using a 2:1 ratio for randomization (2 treatment : 1 sham).||||.76
70924859|NCT03519581|141342622|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||||||.16
70924860|NCT03519581|141342623|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||||||.12
70924861|NCT03519581|141342624|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||.68
70924862|NCT03519581|141342625|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||.96
70924863|NCT03519581|141342626|SUPERIORITY|Two-tailed t-tests and mixed effects regression models||||||0.5|||||||t-test, 2 sided|||||||.50
70924864|NCT01781468|141342639|SUPERIORITY|||||||0.9601|||||||Fisher Exact|||||||0.9601
70924865|NCT01781468|141342640|SUPERIORITY|||||||0.7877|||||||Fisher Exact|||||||0.7877
70924866|NCT01781468|141342641|SUPERIORITY|||||||0.3272|||||||Kruskal-Wallis|||||||0.3272
70924867|NCT01781468|141342642|SUPERIORITY|||||||0.9122|||||||Kruskal-Wallis|||Baseline to Week 4||||0.9122
70924868|NCT01781468|141342642|SUPERIORITY|||||||0.8559|||||||Kruskal-Wallis|||Baseline to Week 8||||0.8559
70924869|NCT00450658|141342644|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|9.5||||0.0018|TWO_SIDED|95.0|3.0|15.9|||Cochran-Mantel-Haenszel|CMH test stratified by use of low-dose aspirin (Yes/No) and prior upper gastrointestinal ulcer history (Yes/No) at randomization.||The primary efficacy endpoint was the proportion of subjects developing UGI (gastric and/or duodenal) ulcers throughout 24 weeks of treatment. A summary including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of UGI ulcers at 24 weeks. The cumulative proportion of subjects developing UGI ulcers at 24 weeks was analyzed using the CMH test stratified by use of low-dose aspirin and prior UGI ulcer history at randomization.||15.9|3.0|0.0018
70924870|NCT00450658|141342645|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|8.2||||0.0051|TWO_SIDED|95.0|1.9|14.4|||Cochran-Mantel-Haenszel|CMH test stratified by use of low-dose aspirin (Yes/No) and prior upper gastrointestinal ulcer history (Yes/No) at randomization.||||14.4|1.9|0.0051
70924871|NCT00450658|141342646|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|3.9||||0.0017|TWO_SIDED|95.0|0.8|7.1|||Cochran-Mantel-Haenszel|CMH test stratified by use of low-dose aspirin and prior UGI ulcer history at randomization.||The secondary efficacy endpoint was the proportion of subjects developing duodenal ulcers throughout 24 weeks of treatment. A summary including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of duodenal ulcers at 24 weeks. The cumulative proportion of subjects developing duodenal ulcers at 24 weeks was analyzed using the CMH test stratified by use of low-dose aspirin and prior UGI ulcer history at randomization.||7.1|0.8|0.0017
70924872|NCT05229146|141342718|SUPERIORITY|||||||0.191||||||No adjustment for multiple comparisons.|t-test, 1 sided|t-statistic = .913, df = 10||One-sided paired-samples t-test comparing baseline to responses immediately following the intervention (approximately one week after baseline).||||.191
70924873|NCT05229146|141342718|SUPERIORITY|||||||0.043||||||Not adjusted for multiple comparisons.|t-test, 1 sided|t-statistic = 1.92, df = 9||One-sided paired-samples t-test comparing baseline to responses at two week follow-up (approximately four weeks after baseline).||||.043
70924874|NCT05229146|141342719|SUPERIORITY||Mean Difference (Final Values)|-1.03||||0.319|TWO_SIDED|||||No adjustments were made. DF = 15.|t-test, 2 sided|||Comparison is between future orientation subscale pre- and post-subscale scores.||||.319
70924875|NCT05229146|141342719|SUPERIORITY||Mean Difference (Final Values)|-0.711||||0.488|TWO_SIDED||||||t-test, 2 sided|No adjustments were made. DF = 15.||Comparison between immediate-orientation subscales.||||.488
70924876|NCT05229146|141342720|SUPERIORITY||Mean Difference (Final Values)|0.438||||0.34|ONE_SIDED||||||t-test, 1 sided|No adjustments were made. DF = 10.||Performed a paired-samples one-sided t-test comparing positive parenting before the intervention to after the intervention.||||.34
70924877|NCT05229146|141342720|SUPERIORITY||Mean Difference (Final Values)|-0.363||||0.362|ONE_SIDED||||||t-test, 1 sided|No adjustments were made. DF = 10.||Performed a one-sided paired-samples t-test to compare negative parenting before and after the intervention.||||.362
70924878|NCT05229146|141342721|SUPERIORITY||Mean Difference (Final Values)|-3.77|||<|0.001|ONE_SIDED||||||t-test, 1 sided|No adjustments, DF = 15||Used a one-sided paired samples t-test to examine changes in the parental involvement subscale from pre-intervention to post-intervention (approximately 4 weeks later).||||<.001
70924879|NCT05229146|141342721|SUPERIORITY||Median Difference (Final Values)|-1.14||||0.137|ONE_SIDED||||||t-test, 1 sided|||Used a one-sided paired samples t-test to examine changes in the positive parenting subscale from pre-intervention to post-intervention (approximately 4 weeks later).||||.137
70924880|NCT05229146|141342721|SUPERIORITY||Mean Difference (Final Values)|2.31||||0.018|ONE_SIDED||||||t-test, 1 sided|No adjustments; DF = 15.||Used a one-sided paired samples t-test to examine changes in the inconsistent discipline subscale from pre-intervention to post-intervention (approximately 4 weeks later).||||.018
70924881|NCT05229146|141342721|SUPERIORITY||Mean Difference (Final Values)|2.39||||0.015|ONE_SIDED||||||t-test, 1 sided|No adjustments; DF = 15.||Used a one-sided paired samples t-test to examine changes in the use of corporal punishment subscale from pre-intervention to post-intervention (approximately 4 weeks later).||||.015
70924882|NCT05229146|141342721|SUPERIORITY||Mean Difference (Final Values)|2.23||||0.021|ONE_SIDED||||||t-test, 1 sided|||Used a one-sided paired samples t-test to examine changes in the poor parental monitoring/supervision subscale from pre-intervention to post-intervention (approximately 4 weeks later).||||.021
70924883|NCT05229146|141342722|SUPERIORITY||Mean Difference (Final Values)|0.878||||0.197|ONE_SIDED||||||t-test, 1 sided|No adjustments; DF = 15||Used a one-sided paired-samples t-test to examine changes in emotion regulation subscale from pre-intervention to post-intervention.||||.197
70924884|NCT05229146|141342722|SUPERIORITY||Mean Difference (Final Values)|0.857||||0.203|ONE_SIDED||||||t-test, 1 sided|No adjustments, DF = 15.||Used a one-sided paired-samples t-test to examine changes in lability/negativity subscale from pre-intervention to post-intervention.||||.203
70924885|NCT01573442|141342747|SUPERIORITY|||||||0.4952|||||||Wilcoxon (Mann-Whitney)|||||||0.4952
70924886|NCT01573442|141342748|SUPERIORITY|||||||0.2116|||||||Fisher Exact|||||||0.2116
70924887|NCT01573442|141342749|SUPERIORITY|||||||0.676|||||||Wilcoxon (Mann-Whitney)|||||||0.6760
70924888|NCT01573442|141342750|SUPERIORITY|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 1||||0.029
70924889|NCT01573442|141342750|SUPERIORITY|||||||0.8214|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 2||||0.8214
70924890|NCT01573442|141342750|SUPERIORITY|||||||0.4952|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 3||||0.4952
70924891|NCT01573442|141342750|SUPERIORITY|||||||0.5232|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 4||||0.5232
70924892|NCT01573442|141342750|SUPERIORITY|||||||0.5522|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 5||||0.5522
70924893|NCT01573442|141342750|SUPERIORITY|||||||0.7005|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 6||||0.7005
70924894|NCT01573442|141342754|SUPERIORITY|||||||0.139|||||||Wilcoxon (Mann-Whitney)|||||||0.139
70924895|NCT01573442|141342755|SUPERIORITY|||||||0.8761|||||||Wilcoxon (Mann-Whitney)|||||||0.8761
70924896|NCT01573442|141342756|SUPERIORITY|||||||0.0176|||||||Wilcoxon (Mann-Whitney)|||||||0.0176
70924897|NCT01573442|141342757|SUPERIORITY|||||||0.7077|||||||Wilcoxon (Mann-Whitney)|||||||0.7077
70924898|NCT01573442|141342758|SUPERIORITY|||||||0.8748|||||||Wilcoxon (Mann-Whitney)|||||||0.8748
70924899|NCT01573442|141342759|SUPERIORITY|||||||0.4335|||||||Wilcoxon (Mann-Whitney)|||||||0.4335
70924900|NCT01573442|141342760|SUPERIORITY|||||||0.286|||||||Wilcoxon (Mann-Whitney)|||||||0.286
70924901|NCT01573442|141342761|SUPERIORITY|||||||0.7694|||||||Wilcoxon (Mann-Whitney)|||||||0.7694
70924902|NCT01573442|141342762|SUPERIORITY|||||||0.9609|||||||Wilcoxon (Mann-Whitney)|||||||0.9609
70924903|NCT03649659|141342763|SUPERIORITY||Odds Ratio (OR)|4.06|||<|0.0001|TWO_SIDED|99.9|2.54|6.48|||Regression, Logistic|Multiple imputation (25) of missing data, FCS methods. Group comparisons using GEE logistic model, exchangeable correlation, study site as covariate.||||6.48|2.54|<0.0001
70924904|NCT03649659|141342764|SUPERIORITY||Odds Ratio (OR)|4.78|||<|0.0001|TWO_SIDED|99.9|2.84|8.05||Multiple imputation (25) of missing data, FCS methods. Group comparisons using GEE logistic model, exchangeable correlation, study site as covariate.|Regression, Logistic|||||8.05|2.84|<0.0001
70924905|NCT03649659|141342765|SUPERIORITY||Odds Ratio (OR)|5.84|||<|0.0001|TWO_SIDED|99.9|3.59|9.51||Multiple imputation (25) of missing data, FCS methods. Group comparisons using GEE logistic model, exchangeable correlation, study site as covariate.|Regression, Logistic|||||9.51|3.59|<0.0001
70924906|NCT03649659|141342766|SUPERIORITY||Odds Ratio (OR)|0.95||||0.8942|TWO_SIDED|99.9|0.25|3.54||Multiple imputation (25) of missing data, FCS methods. Group comparisons using GEE logistic model, exchangeable correlation, study site as covariate.|Regression, Logistic|||||3.54|0.25|0.8942
70924907|NCT01963793|141342793|SUPERIORITY||Mean Difference (Final Values)|-1.51||||0.58|TWO_SIDED|95.0|-7.12|4.11|||t-test, 2 sided|||||4.11|-7.12|0.58
70924908|NCT01552473|141342815|OTHER|This is a functional Magnetic Resonance Imaging analysis. We aimed to determine whether functional brain network connectivity was equivalent between the two intervention arms prior to the interventions beginning. This was computed in significant numbers of connections between the two groups.|pNBS|0.0001||||0.01|TWO_SIDED|||||This is a p-value that is used in Network Based Statistics analysis for resting-state functional brain network data.|Network Based Statistics analysis|This is a type of statistical analysis used to test for group differences among functional connectivity levels between two or more groups.|This analysis evaluated monotonic changes from time point 1 (pre-intervention) to time points 2 (immediate post-intervention) and 3 (12 weeks post-intervention) that may have occurred between the SMART and BHW groups.|A network-based statistics analysis was carried out to determine brain connectivity differences observed at time points two (initial post-intervention testing phase) and three (the final post-intervention phase) occurring three months post-intervention.||||0.01
70924909|NCT05089734|141342839|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0534|TWO_SIDED|95.0|0.68|1.04||Stratified log-rank test adjusted for stratification factors: histology and best response to last prior immune therapy received.|Log Rank|||||1.04|0.68|0.0534
70924910|NCT05089734|141342840|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.1938|TWO_SIDED|95.0|0.77|1.11||Stratified log-rank test adjusted for stratification factors: histology and best response to last prior immune therapy received.|Log Rank|||||1.11|0.77|0.1938
70924911|NCT05089734|141342841|SUPERIORITY||Difference in Proportions|-4.3||||0.9255|TWO_SIDED|95.0|-10.1|1.5||The 1-sided p-value is calculated using Cochran Mantel-Haenszel test adjusted for randomization stratification factors of histology, and best response to last prior immune therapy received.|Cochran-Mantel-Haenszel|||||1.5|-10.1|0.9255
71044038|NCT00107042|141597486|SUPERIORITY_OR_OTHER||Responding rate|98.08|||||TWO_SIDED|95.0|89.74|99.95||A p-value has not been entered because there is only one study arm in this analysis.|Exact 95% CI|||||99.95|89.74|
70924912|NCT05089734|141342846|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.002|TWO_SIDED|95.0|0.61|0.91||Stratified log-rank test adjusted for stratification factors: histology and best response to last prior immune therapy received.|Log Rank|||||0.91|0.61|0.0020
70924913|NCT05089734|141342847|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0125|TWO_SIDED|95.0|0.66|0.97||Stratified log-rank test adjusted for stratification factors: histology and best response to last prior immune therapy received.|Log Rank|||||0.97|0.66|0.0125
70924914|NCT00667251|141342857|OTHER||Hazard Ratio (HR)|1.367||||0.001|TWO_SIDED|95.0|1.133|1.648|||Log Rank|||PFS at the time of Primary Analysis (IIT population)||1.648|1.133|0.0010
70924915|NCT00667251|141342857|OTHER||Hazard Ratio (HR)|1.484||||0.0002|TWO_SIDED|95.0|1.204|1.829|||Log Rank|||PFS at the time of Primary Analysis (Central HER2+ population)||1.829|1.204|0.0002
70924916|NCT00667251|141342858|OTHER||Hazard Ratio (HR)|1.3722|||||TWO_SIDED|95.0|1.1466|1.6422|||||Stratified HR for LTax/L versus TTax/T|PFS at the time of Final Analysis (IIT population)||1.6422|1.1466|
70924917|NCT00667251|141342858|OTHER||Hazard Ratio (HR)|1.4968|||||TWO_SIDED|95.0|1.2251|1.8288|||||Stratified HR for LTax/L versus TTax/T|PFS at the time of Final Analysis (Central HER2+ population)||1.8288|1.2251|
70924918|NCT00667251|141342859|OTHER||Hazard Ratio (HR)|1.3786|||||TWO_SIDED|95.0|1.0246|1.8549|||||Stratified HR for LTax/L versus TTax/T|Overall Survival (OS) (IIT population)||1.8549|1.0246|
70924919|NCT00667251|141342860|OTHER||Hazard Ratio (HR)|1.5818|||||TWO_SIDED|95.0|1.1181|2.2379|||||Stratified HR for LTax/L versus TTax/T|Overall Survival (OS) (Central HER2+ population)||2.2379|1.1181|
70924920|NCT00667251|141342863|OTHER||Hazard Ratio (HR)|1.0916|||||TWO_SIDED|95.0|0.7271|1.6389|||||Stratified HR for LTax/L versus TTax/T|Time to Central Nervous System (CNS) metastasis (IIT population)||1.6389|0.7271|
70924921|NCT00667251|141342864|OTHER||Hazard Ratio (HR)|1.0951|||||TWO_SIDED|95.0|0.7144|1.6787|||||Stratified HR for LTax/L versus TTax/T|Time to Central Nervous System (CNS) metastasis (Central HER2+ population)||1.6787|0.7144|
70924922|NCT00667251|141342869|OTHER||Hazard Ratio (HR)|1.0091|||||TWO_SIDED|95.0|0.809|1.2586|||||Stratified HR for LTax/L versus TTax/T|Time to Response (TTR) (IIT population)||1.2586|0.8090|
70924923|NCT00667251|141342870|OTHER||Hazard Ratio (HR)|0.9573|||||TWO_SIDED|95.0|0.7544|1.2148|||||Stratified HR for LTax/L versus TTax/T|Time to Response (TTR) (Central HER2+ population)||1.2148|0.7544|
70924924|NCT00667251|141342871|OTHER||Hazard Ratio (HR)|1.4866|||||TWO_SIDED|95.0|1.1479|1.9251|||||Stratified HR for LTax/L versus TTax/T|Duration of Response (DoR) (IIT population)||1.9251|1.1479|
70924925|NCT00667251|141342872|OTHER||Hazard Ratio (HR)|1.5594|||||TWO_SIDED|95.0|1.1767|2.0666|||||Stratified HR for LTax/L versus TTax/T|Duration of Response (DoR) (Central HER2+ population)||2.0666|1.1767|
70924926|NCT01212029|141342889|OTHER|One sample t-tests of standardized regression coefficients of RMSSD predicting O2Hb during baseline||||||0.008||||||t-test was performed 16 times for 16 fNIRS channels. The reported p-value is an uncorrected value for channel 10.|t-test, 2 sided|||Null hypothesis: there is no significant correlation between RMSSD and O2Hb levels during baseline||||0.008
70924927|NCT01212029|141342890|OTHER|||||||0.0105|||||||Tukey method|||||||0.0105
70924928|NCT03131648|141342893|SUPERIORITY|Primary endpoints tested sequentially at a 5% significance level.|Risk Difference (RD)|8.6||||0.002|TWO_SIDED|95.0|4.1|13.1||Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.|Cochran-Mantel-Haenszel|Primary endpoints tested sequentially at a 5% significance level.|Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.The null hypothesis of no difference in response rates between tralokinumab and placebo were tested against the 2-sided alternative that there is a difference.||13.1|4.1|0.002
70924929|NCT03131648|141342894|SUPERIORITY|Primary endpoints tested sequentially at a 5% significance level.|Risk Difference (RD)|12.1|||<|0.001|TWO_SIDED|95.0|6.5|17.7||Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.|Cochran-Mantel-Haenszel|Primary endpoints tested sequentially at a 5% significance level.|Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rates between tralokinumab and placebo were tested against the 2-sided alternative that there is a difference.||17.7|6.5|<0.001
70924930|NCT03131648|141342895|SUPERIORITY||Risk Difference (RD)|9.7||||0.002|TWO_SIDED|95.0|4.4|15.0||Based on the primary analysis of the primary estimand 'Composite', subjects who received rescue medication prior to Week 16 or have missing data at Week 16 were considered as non-responders.|Cochran-Mantel-Haenszel|Tested sequentially at a 5% significance level.|Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Reduction of Worst Daily Pruritus NRS weekly average ≥4 at Week 16 was tested after the sequential testing of IGA 0/1 and EASI75 if these tests showed statistical significance.||15|4.4|0.002
70924931|NCT03131648|141342896|SUPERIORITY|Multiplicity adjustment using the Holm method.|Difference of least square means|-10.4|||<|0.001|TWO_SIDED|95.0|-14.4|-6.5||Based on the primary analysis of the primary estimand 'hypothetical'. Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or after initiation of rescue medication were not included in the analysis.||-6.5|-14.4|<0.001
70924932|NCT03131648|141342897|SUPERIORITY|Multiplicity adjustment using Holm method.|Difference of least square means|-2.1||||0.002|TWO_SIDED|95.0|-3.4|-0.8||Based on the primary analysis of the primary estimand 'hypothetical'. Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included.||-0.8|-3.4|0.002
71004587|NCT00804986|141517304|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.04||||0.799||95.0||||p-value represents change from baseline to Week 12 for fasting total cholesterol, 2.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.799
71004588|NCT00804986|141517304|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.32||||0.029||95.0||||p-value represents change from baseline to Week 12 for fasting total cholesterol, 6.2 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.029
70924933|NCT03131648|141342898|SUPERIORITY||Risk Difference (RD)|6.0||||0.68|TWO_SIDED|95.0|-21.8|33.7||"Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication or were transferred to open-label treatment were considered non-responders.~P value was considered non-significant."|Cochran-Mantel-Haenszel|This test was not statistically significant and hence next maintenance endpoint in the sequential testing procedure was not evaluated.|Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo."||33.7|-21.8|0.68
70924934|NCT03131648|141342898|SUPERIORITY||Risk Difference (RD)|-9.5||||0.5|TWO_SIDED|95.0|-37.1|18.0||Test not evaluated for significance. Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication or were transferred to open-label treatment were considered non-responders.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo."||18.0|-37.1|0.50
71004589|NCT00804986|141517304|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.12||||0.439||95.0||||p-value represents change from baseline to Week 12 for fasting total cholesterol, 12.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.439
71004590|NCT00804986|141517304|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.27||||0.062||95.0||||p-value represents change from baseline to Week 12 for fasting total cholesterol, 17.6 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.062
71004591|NCT00804986|141517305|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.16||||0.8003||95.0||||p-value represents change from baseline to Week 12 for fasting weight, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.8003
71004592|NCT00804986|141517305|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.26||||0.6736||95.0||||p-value represents change from baseline to Week 12 for fasting weight, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.6736
71044039|NCT00107042|141597487|SUPERIORITY_OR_OTHER||Responding Rate|91.49||||||95.0|79.62|97.63||A p-value has not been entered because there is only one study arm in this analysis.|Exact 95 % confidence interval|||||97.63|79.62|
71044040|NCT00107042|141597488|SUPERIORITY_OR_OTHER||Responding Rate %|98.11|||||TWO_SIDED|95.0|89.93|99.95||A p-value has not been entered because there is only one study arm in this analysis.|Exact 95% confidence interval||"For overall response, if a subject is reactive at either 1-month or 12-month, then the overall response is considered Positive. If a subject is non-reactive at both 1-month and 12-month, then the overall response for this subject is Negative."|||99.95|89.93|
71044041|NCT00107042|141597489|SUPERIORITY_OR_OTHER|||||||0.2938||95.0|||||Fisher Exact|||||||0.2938
71044042|NCT00107042|141597489|SUPERIORITY_OR_OTHER||Responding Rate %|85.37|||||TWO_SIDED|95.0|70.83|94.43|||95 % confidence interval|||||94.43|70.83|
71044043|NCT00107042|141597489|SUPERIORITY_OR_OTHER||Responding Rate %|93.62|||||TWO_SIDED|95.0|82.46|98.66|||95% confidence interval|||||98.66|82.46|
71044044|NCT01286558|141597495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46||||||95.0|-0.22|3.14|||ANCOVA|||||3.14|-0.22|
71044045|NCT01286558|141597496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.14||||||95.0|-0.36|4.64|||ANCOVA|||||4.64|-0.36|
71044046|NCT01286558|141597497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||||95.0|-2.58|0.15|||ANCOVA|||||0.15|-2.58|
71044047|NCT01286558|141597498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||||95.0|-4.16|0.35|||ANCOVA|||||0.35|-4.16|
71044048|NCT01286558|141597499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89||||||95.0|-2.57|0.79|||ANCOVA|||||0.79|-2.57|
71101403|NCT04439903|141710799|OTHER||Slope|-0.06091|STANDARD_ERROR_OF_MEAN|0.042266||0.17514|TWO_SIDED||||||Regression, Linear||Predictor variable 2: Minutes of interaction with the Web-Based Simulation Tool per participant per week.|||||0.17514
71044049|NCT01286558|141597500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.64||||||95.0|-4.27|0.99|||ANCOVA|||||0.99|-4.27|
71044050|NCT03662308|141597514|SUPERIORITY||Mean Difference (Final Values)|0.6|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
71044051|NCT03702049|141597548|OTHER|Change in score at 3 months|Mean Difference (Final Values)|-0.24||||0.603|TWO_SIDED||||||Mixed Models Analysis|||Change in score at 3 months||||0.603
71044052|NCT03702049|141597548|OTHER|Change at 6 months|Mean Difference (Final Values)|-0.12||||0.805|TWO_SIDED||||||Mixed Models Analysis|||6 month outcome||||0.805
71044053|NCT03702049|141597549|OTHER||Odds Ratio (OR)|0.83||||0.672|TWO_SIDED|95.0|0.39|1.79|||Regression, Logistic|||3 month outcome||1.79|0.39|0.672
71101404|NCT04439903|141710800|OTHER||Intercept|-0.28825|STANDARD_ERROR_OF_MEAN|0.59949||0.63929|TWO_SIDED||||||Regression, Linear|||||||0.63929
71044054|NCT03702049|141597549|OTHER||Odds Ratio (OR)|0.49||||0.165|TWO_SIDED|95.0|0.18|1.34|||Regression, Logistic|||6 month outcome||1.34|0.18|0.165
71044055|NCT03702049|141597550|OTHER||Mean Difference (Final Values)|-0.31||||0.719|TWO_SIDED||||||Mixed Models Analysis|||3 month outcome||||0.719
71044056|NCT03702049|141597550|OTHER||Mean Difference (Final Values)|0.43||||0.626|TWO_SIDED||||||Mixed Models Analysis|||6 month outcome||||0.626
71044057|NCT03702049|141597551|OTHER||Mean Difference (Final Values)|0.83||||0.1668|TWO_SIDED|95.0|-0.36|2.03|||t-test, 2 sided|||||2.03|-0.36|0.1668
71044058|NCT03702049|141597552|OTHER||Mean Difference (Final Values)|1.5||||0.9198|TWO_SIDED|95.0|-29.6|32.7|||t-test, 2 sided|||3 month outcome||32.7|-29.6|0.9198
71044059|NCT03702049|141597552|OTHER||Mean Difference (Final Values)|12.5||||0.5015|TWO_SIDED|95.0|-25.6|50.7|||t-test, 2 sided|||6 month||50.7|-25.6|0.5015
71101405|NCT04439903|141710800|OTHER||Slope|-0.14422|STANDARD_ERROR_OF_MEAN|0.1581||0.37964|TWO_SIDED||||||Regression, Linear||Predictor variable 1: Number of simulations per participant per week.|||||0.37964
71101406|NCT04439903|141710800|OTHER||Slope|0.06718|STANDARD_ERROR_OF_MEAN|0.056895||0.26057|TWO_SIDED||||||Regression, Linear||Predictor variable 2: Minutes of interaction with the Web-Based Simulation Tool per participant per week.|||||0.26057
70924935|NCT03131648|141342899|SUPERIORITY||Risk Difference (RD)|21.2||||0.056|TWO_SIDED|95.0|-0.2|42.6||Test not evaluated for significance. Based on the primary analysis of the primary estimand 'composite'. Subjects who received rescue medication or were transferred to open-label treatment are considered non-responders.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo."||42.6|-0.2|0.056
70924936|NCT03131648|141342899|SUPERIORITY||Risk Difference (RD)|11.7||||0.27|TWO_SIDED|95.0|-8.7|32.0||Test not evaluated for significance. Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication or were transferred to open-label treatment were considered non-responders.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo."||32.0|-8.7|0.27
71101407|NCT04003142|141710811|SUPERIORITY|Least squares Mean (LSM), Standard error (SE), Confidence interval (CI), Mixed model repeated measures (MMRM), Change from Baseline (CFB), Dependent variable (dv), Treatment (tr), Week (wk), Baseline (bl), Weight (wt)|Least squares (LS) Mean difference|-1.82|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|-2.73|-0.91||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.91|-2.73|<0.001
71101408|NCT04003142|141710811|SUPERIORITY||LSMean difference|-2.55|STANDARD_ERROR_OF_MEAN|0.46|<|0.001||95.0|-3.45|-1.64||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-1.64|-3.45|<0.001
70924937|NCT03131648|141342902|SUPERIORITY|"Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Risk Difference (RD)|20.1|||<|0.001|TWO_SIDED|95.0|13.3|26.8|||Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|||26.8|13.3|<0.001
71004593|NCT00804986|141517305|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-1.53||||0.0123||95.0||||p-value represents change from baseline to Week 12 for fasting weight, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0123
71004594|NCT00804986|141517305|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.44||||0.4771||95.0||||p-value represents change from baseline to Week 12 for fasting weight, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.4771
71004595|NCT00804986|141517305|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-2.01||||0.0013||95.0||||p-value represents change from baseline to Week 12 for fasting weight, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0013
71004596|NCT00654368|141517310|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the one-sided 95% confidence interval (CI), defined below, exceeded the noninferiority margin of -0.6, then noninferiority was to be concluded.|Mean Difference|-0.41|||||TWO_SIDED|95.0|-0.75|-0.06|||||The 95% CI was calculated using the mean square error from an analysis of variance (ANOVA) fitted with effects for treatment and covariates of duration of disease, type of reimbursement, and 6 month DAS28.|||-0.06|-0.75|
71004597|NCT03296072|141517323|OTHER||Difference of Least Square mean|7.69|||<|0.0001|TWO_SIDED|95.0|5.18|10.19|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.|||10.19|5.18|<.0001
71004598|NCT03296072|141517324|OTHER||Difference of Least Square mean|33.29|||<|0.0001|TWO_SIDED|95.0|28.89|37.68|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.|||37.68|28.89|<.0001
71004599|NCT03296072|141517325|OTHER||Difference of Least Square mean|1.81|||<|0.0001|TWO_SIDED|95.0|1.59|2.04|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.|||2.04|1.59|<.0001
71004600|NCT03296072|141517326|OTHER||Difference of Least Square mean|7.57|||<|0.0001|TWO_SIDED|95.0|5.07|11.07|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.|||11.07|5.07|<.0001
71004601|NCT03296072|141517327|OTHER||Difference of Least Square mean|10.98|||<|0.0001|TWO_SIDED|95.0|6.58|15.37|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.|||15.37|6.58|<.0001
71004602|NCT03296072|141517328|OTHER||Difference of Least Square mean|0.97|||<|0.0001|TWO_SIDED|95.0|0.75|1.2|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.|||1.20|0.75|<.0001
71101409|NCT04003142|141710811|SUPERIORITY|||||||0.049|||||||Hochberg|||||||0.049
71101410|NCT04003142|141710811|SUPERIORITY||||||<|0.001|||||||Hochberg|||||||<0.001
70924938|NCT03131648|141342903|SUPERIORITY||Risk Difference (RD)|10.3|||<|0.001|TWO_SIDED|95.0|6.4|14.1||"Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|||14.1|6.4|<0.001
70924939|NCT03131648|141342904|SUPERIORITY||Difference of least square means|-6.4|||<|0.001|TWO_SIDED|95.0|-8.8|-4.1||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change will be imputed as 0.||-4.1|-8.8|<0.001
70924940|NCT03131648|141342905|SUPERIORITY||Risk Difference (RD)|5.7||||0.007|TWO_SIDED|95.0|2.5|8.9||"Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication prior to Week 16 or with missing data at Week 16 were considered nonresponders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|||8.9|2.5|0.007
70924941|NCT03131648|141342906|SUPERIORITY||Risk Difference (RD)|14.1|||<|0.001|TWO_SIDED|95.0|8.6|19.6||"Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication prior to Week 16 or with missing data at Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference stratified by region and disease severity.|||19.6|8.6|<0.001
70924942|NCT03131648|141342907|SUPERIORITY||Difference of least square means|-0.9|||<|0.001|TWO_SIDED|95.0|-1.4|-0.4||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included. In case of no post-baseline assessments before initiation of rescue medication, the Week 1 change will be imputed as 0.||-0.4|-1.4|<0.001
70924943|NCT03131648|141342908|SUPERIORITY||Risk Difference (RD)|15.2|||<|0.001|TWO_SIDED|95.0|9.2|21.3||"Subjects who received rescue medication prior to Week 16 or have missing data at Week 16 were considered as non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|||21.3|9.2|<0.001
70924944|NCT03131648|141342909|SUPERIORITY||Risk Difference (RD)|13.0||||0.001|TWO_SIDED|95.0|5.4|20.5||"Subjects who received rescue medication prior to Week 16 or have missing data at Week 16 were considered as non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|||20.5|5.4|0.001
70924945|NCT02671903|141342910|SUPERIORITY||Fixed Effect for Treatment|0.25||||0.3|TWO_SIDED|95.0|-0.23|0.73|||Mixed Models Analysis|||Change in treatment effect taken from mixed-model output||0.73|-0.23|0.3
70924946|NCT04258709|141342922|SUPERIORITY|||||||0.12|||||||Chi-squared|||||||.1200
70924947|NCT04258709|141342922|SUPERIORITY||Odds Ratio (OR)|0.593||||0.0474|TWO_SIDED|95.0|0.352|0.9907|||Regression, Logistic||Adjusted for race, Iowa Infant Feeding Attitudes Score at baseline, infant gestational age, NICU admission, maternal age at enrollment, WIC enrollment at baseline, maternal pre-pregnancy BMI. This is an adjusted odds ratio.|||.9907|.352|.0474
70924948|NCT04258709|141342923|SUPERIORITY|||||||0.5201|||||||t-test, 1 sided|||||||.5201
70924949|NCT04258709|141342923|SUPERIORITY||Slope|0.1399||||0.9178|TWO_SIDED|95.0|-2.5299|2.8098|||Regression, Linear|||||2.8098|-2.5299|.9178
70924950|NCT04258709|141342924|SUPERIORITY|||||||0.8614|||||||t-test, 1 sided|||||||.8614
70924951|NCT04258709|141342924|SUPERIORITY||Odds Ratio (OR)|1.0763||||0.7836|TWO_SIDED|95.0|0.6364|1.8216|||Regression, Logistic|||||1.8216|.6364|.7836
71004603|NCT00959699|141517329|SUPERIORITY_OR_OTHER||Strata-Adjusted Difference|33.7||||0.0008|TWO_SIDED|95.0|14.1|53.3||The Cochran-Mantel-Haenszel p-value is adjusted for randomization strata of HCV-RNA (\< or \>= 800,000 IU/mL) and Cirrhosis/Fibrosis (Yes or No)|Cochran-Mantel-Haenszel|||The methodology for 95% Confidence Interval (CI) is based on a Modified Koch approach which adjusted for Randomization Strata of Cirrhosis/Fibrosis (Yes or No). The adjustment of randomization strata of HCV-RNA (\< or \>= 800,000 IU/mL) was not possible due to sparse data.||53.3|14.1|0.0008
71004604|NCT00959699|141517330|SUPERIORITY_OR_OTHER||Observed Difference|34.2||||0.0007|TWO_SIDED|95.0|14.5|53.9||The Cochran-Mantel-Haenszel p-value is adjusted for randomization strata of HCV-RNA (\< or \>= 800,000 IU/mL) and Cirrhosis/Fibrosis (Yes or No)|Cochran-Mantel-Haenszel|||The methodology for 95% CI is based on the asymptotic normal approximation to the binomial distribution||53.9|14.5|0.0007
71004605|NCT02858713|141517359|SUPERIORITY||Odds Ratio (OR)|2.99|||=|0.004|TWO_SIDED|95.0|1.42|6.28|||Regression, Logistic|||||6.28|1.42|=0.004
71004606|NCT02858713|141517360|SUPERIORITY||Coefficient|-0.415|||=|0.545|TWO_SIDED|95.0|-1.77|0.939|||Regression, Linear|||DLQI: Change baseline to week 4||0.939|-1.770|=0.545
71004607|NCT02858713|141517360|SUPERIORITY||Coefficient|-0.415||||0.545|TWO_SIDED|95.0|-1.77|0.939|||Regression, Linear|||DLQI: Change from baseline to week 4||0.939|-1.770|0.545
71004608|NCT02858713|141517360|SUPERIORITY||Coefficient|-0.581||||0.45|TWO_SIDED|95.0|-2.099|0.938|||Regression, Linear|||DLQI: Change from baseline to week 8||0.938|-2.099|0.450
70924952|NCT04258709|141342925|SUPERIORITY|||||||0.9788|||||||Chi-squared|||||||.9788
70924953|NCT04258709|141342925|SUPERIORITY||Odds Ratio (OR)|1.0307||||0.9119|TWO_SIDED|95.0|0.603|1.7067|||Regression, Logistic|||||1.7067|.603|.9119
70924954|NCT04258709|141342926|SUPERIORITY||Odds Ratio (OR)|0.7157||||0.2173|TWO_SIDED|95.0|0.4192|1.216|||Regression, Logistic|||||1.216|.4192|.2173
70924955|NCT04258709|141342927|SUPERIORITY||Odds Ratio (OR)|0.7157||||0.5209|TWO_SIDED|95.0|0.4192|1.216|||Regression, Logistic|||||1.216|.4192|.5209
70924956|NCT04258709|141342930|SUPERIORITY|||||||0.4258|||||||Chi-squared|||||||.4258
70924957|NCT04258709|141342930|SUPERIORITY||Odds Ratio (OR)|0.8882||||0.6246|TWO_SIDED|95.0|0.5523|1.4283|||Regression, Logistic|||||1.4283|.5523|.6246
70924958|NCT04258709|141342931|SUPERIORITY|||||||0.5613|||||||Chi-squared|||||||.5613
71101411|NCT04003142|141710812|SUPERIORITY||LSMean Difference|-1.86|STANDARD_ERROR_OF_MEAN|0.55|<|0.001||95.0|-2.94|-0.78||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.78|-2.94|<0.001
71101412|NCT04003142|141710812|SUPERIORITY||LSMean difference|-2.53|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|-3.6|-1.46||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-1.46|-3.60|<0.001
71101413|NCT04003142|141710812|SUPERIORITY|||||||0.049|||||||Hochberg|||||||0.049
71101414|NCT04003142|141710812|SUPERIORITY||||||<|0.001|||||||Hochberg|||||||<0.001
71101415|NCT04003142|141710813|SUPERIORITY||LSMean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.06||0.021||95.0|-0.27|-0.02||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.02|-0.27|0.021
71101416|NCT04003142|141710813|SUPERIORITY||LSMean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.06|<|0.001||95.0|-0.41|-0.16||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.16|-0.41|<0.001
71101417|NCT04003142|141710813|SUPERIORITY|||||||0.049|||||||Hochberg|||||||0.049
71101418|NCT04003142|141710813|SUPERIORITY||||||<|0.001|||||||Hochberg|||||||<0.001
71101419|NCT04003142|141710814|SUPERIORITY||LSMean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.049||95.0|-0.33|0.0||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||0.00|-0.33|0.049
71101420|NCT04003142|141710814|SUPERIORITY||LSMean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.08|<|0.001||95.0|-0.45|-0.13||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.13|-0.45|<0.001
71101421|NCT04003142|141710814|SUPERIORITY|||||||0.049|||||||Hochberg|||||||0.049
70924959|NCT04258709|141342931|SUPERIORITY||Odds Ratio (OR)|0.7157||||0.2173|TWO_SIDED|95.0|0.4206|1.2178|||Regression, Logistic|||||1.2178|.4206|.2173
70924960|NCT04258709|141342932|SUPERIORITY|||||||0.6291|||||||Chi-squared|||||||.6291
71004609|NCT02858713|141517360|SUPERIORITY||Coefficient|-0.77||||0.348|TWO_SIDED|95.0|-2.389|0.848|||Regression, Linear|||DLQI: Change from baseline to week 26||0.848|-2.389|0.348
71004610|NCT02858713|141517361|SUPERIORITY||coefficient|0.4||||0.047|TWO_SIDED|95.0|0.005|0.795|||Regression, Linear|||LS-PGA: Change from baseline to week 4||0.795|0.005|0.047
71004611|NCT02858713|141517361|SUPERIORITY||Coefficient|0.091||||0.662|TWO_SIDED|95.0|-0.321|0.504|||Regression, Linear|||LS-PGA: Change from baseline to week 8||0.504|-0.321|0.662
71044060|NCT00573170|141597553|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.378|TWO_SIDED|95.0|0.7|2.5||Compares odds ratio.|Generalized Estimating Equations|||||2.5|0.7|0.378
71044061|NCT01833533|141597587|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus placebo RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 65% to achieve noninferiority.|Percentage of Participants|90.2|||||TWO_SIDED|95.0|86.2|94.3|||||95% CI was calculated using the normal approximation to the binomial distribution.|Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides \>95% power to demonstrate noninferiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (75%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||94.3|86.2|
71004612|NCT02858713|141517361|SUPERIORITY||Coefficient|0.18||||0.424|TWO_SIDED|95.0|-0.264|0.625|||Regression, Linear|||LS-PGA: Change from baseline to week 26||0.625|-0.264|0.424
71004613|NCT00126425|141517362|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.44|||=|0.004|TWO_SIDED|95.0|0.23|0.83||At 0.025 level of significance.|Cox Proportional Hazards Model|||"Analysis based on Reader A readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time t was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.83|0.23|=0.004
71004614|NCT00126425|141517362|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.44|||=|0.004|TWO_SIDED|95.0|0.23|0.84||At 0.025 level of significance.|Cox Proportional Hazards Model|||"Analysis based on Reader B readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time t was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.84|0.23|=0.004
71004615|NCT00126425|141517362|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.44|||=|0.004|TWO_SIDED|95.0|0.23|0.84||At 0.025 level of significance.|Cox Proportional Hazards Model|||"Analysis based on Reader C readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time t was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.84|0.23|=0.004
71004616|NCT02332876|141517373|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71004617|NCT02614261|141517393|SUPERIORITY||LSMean Difference|-2.09|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-2.92|-1.26|||Mixed Models Analysis|||||-1.26|-2.92|<.001
71004618|NCT02614261|141517393|SUPERIORITY||LSMean Difference|-1.88|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-2.71|-1.05|||Mixed Models Analysis|||||-1.05|-2.71|<.001
71044062|NCT01833533|141597587|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks for the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 65% to achieve noninferiority.|Percentage of Participants|97.0|||||TWO_SIDED|95.0|93.7|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution.|Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides \>95% power to demonstrate noninferiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (75%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|93.7|
71044063|NCT01833533|141597588|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71101422|NCT04003142|141710814|SUPERIORITY||||||<|0.001|||||||Hochberg|||||||<0.001
71101423|NCT04003142|141710815|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.7||0.381|TWO_SIDED|95.0|-2.1|0.8||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||0.8|-2.1|0.381
70924961|NCT04258709|141342932|SUPERIORITY||Odds Ratio (OR)|1.1955||||0.5426|TWO_SIDED|95.0|0.8745|1.3931|||Regression, Logistic|||||1.3931|.8745|.5426
70924962|NCT04258709|141342933|SUPERIORITY|||||||0.9071|||||||Chi-squared|||||||.9071
70924963|NCT04258709|141342933|SUPERIORITY||Odds Ratio (OR)|1.0233||||0.9328|TWO_SIDED|95.0|0.7751|1.2084|||Regression, Logistic|||||1.2084|.7751|.9328
70924964|NCT04258709|141342934|SUPERIORITY||Slope|0.8213||||0.5548|TWO_SIDED|95.0|-1.9161|3.5588|||Regression, Linear|||||3.5588|-1.9161|.5548
70924965|NCT04258709|141342935|SUPERIORITY||Slope|1.2412||||0.3861|TWO_SIDED|95.0|-1.5771|4.0594|||Regression, Linear|||||4.0594|-1.5771|.3861
70924966|NCT04258709|141342936|SUPERIORITY|||||||0.4779|||||||t-test, 1 sided|||||||.4779
70924967|NCT04258709|141342937|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
70924968|NCT04258709|141342937|SUPERIORITY||Odds Ratio (OR)|0.9508||||0.9163|TWO_SIDED|95.0|0.3669|2.4621|||Regression, Logistic|||||2.4621|.3669|.9163
70924969|NCT04258709|141342938|SUPERIORITY||Odds Ratio (OR)|1.1084||||0.8031|TWO_SIDED|95.0|0.4937|2.4882|||Regression, Logistic|||||2.4882|.4937|.8031
70924970|NCT04258709|141342939|SUPERIORITY||Odds Ratio (OR)|1.1346||||0.8175|TWO_SIDED|95.0|0.3882|3.3161|||Regression, Logistic|||||3.3161|.3882|.8175
70924971|NCT04258709|141342940|SUPERIORITY||Odds Ratio (OR)|0.6964||||0.434|TWO_SIDED|95.0|0.2813|1.7241|||Regression, Logistic|||||1.7241|.2813|.434
70924972|NCT04258709|141342941|SUPERIORITY||Odds Ratio (OR)|1.2533||||0.4968|TWO_SIDED|95.0|0.6534|2.4041|||Regression, Logistic|||||2.4041|.6534|.4968
70924973|NCT04258709|141342942|SUPERIORITY||Odds Ratio (OR)|1.0288||||0.9005|TWO_SIDED|95.0|0.659|1.6062|||Regression, Logistic|||||1.6062|.659|.9005
70924974|NCT04258709|141342943|SUPERIORITY||Slope|-1.4018||||0.127|TWO_SIDED|95.0|-3.2052|0.4015|||Regression, Linear|||||.4015|-3.2052|.127
70924975|NCT04258709|141342944|SUPERIORITY||Slope|-1.8958||||0.07|TWO_SIDED|95.0|-3.9475|0.1559|||Regression, Linear|||||.1559|-3.9475|.07
70924976|NCT04258709|141342945|SUPERIORITY||Slope|-0.506||||0.6299|TWO_SIDED|95.0|-2.574|1.562|||Regression, Linear|||||1.562|-2.574|.6299
70924977|NCT04258709|141342946|SUPERIORITY||Odds Ratio (OR)|0.7573||||0.3835|TWO_SIDED|95.0|0.4029|1.4138|||Regression, Logistic|||||1.4138|.4029|.3835
70924978|NCT04258709|141342947|SUPERIORITY||Odds Ratio (OR)|0.784||||0.459|TWO_SIDED|95.0|0.409|1.4912|||Regression, Logistic|||||1.4912|.409|.459
70924979|NCT04258709|141342948|SUPERIORITY||Odds Ratio (OR)|0.9338||||0.8499|TWO_SIDED|95.0|0.458|1.9039|||Regression, Logistic|||||1.9039|.458|.8499
71004619|NCT02614261|141517394|SUPERIORITY||Odds Ratio (OR)|1.623||||0.004|TWO_SIDED|95.0|1.167|2.256|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥50%,||2.256|1.167|.004
71004620|NCT02614261|141517394|SUPERIORITY||Odds Ratio (OR)|1.788|||<|0.001|TWO_SIDED|95.0|1.291|2.474|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥50%||2.474|1.291|<.001
70924980|NCT05324124|141342985|OTHER||Ratio of Geometric Least Squares Mean|0.952|||||TWO_SIDED|90.0|0.876|1.03||||||||1.03|0.876|
70924981|NCT05324124|141342986|OTHER||Ratio of Geometric Least Squares Mean|0.949|||||TWO_SIDED|90.0|0.869|1.04||||||||1.04|0.869|
71004621|NCT02614261|141517394|SUPERIORITY||Odds Ratio (OR)|1.498||||0.102|TWO_SIDED|95.0|0.923|2.43|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥75%||2.430|0.923|.102
70924982|NCT05324124|141342987|OTHER||Ratio of Geometric Least Squares Mean|0.829|||||TWO_SIDED|90.0|0.744|0.925||||||||0.925|0.744|
70924983|NCT03771898|141343070|SUPERIORITY|Survival probability free of loss of locomotion estimated up to Week 106 (or two years).|Difference in survival probability (%)|-2.2|||=|0.585|TWO_SIDED|95.0|-22.2|17.7||One-sided, over time intervals during entire follow-up. Stratified generalized log-rank test was used, where matching identification created from matching process in SAS PSMATCH Procedure used as strata.|Log Rank||For the shared time interval up to Week 106 (or two years).|Interval censoring survival analysis.||17.7|-22.2|=0.585
70924984|NCT05563246|141343097|SUPERIORITY||LS Mean Difference (Final Values)|-47.61|||<|0.001|TWO_SIDED|95.0|-57.68|-35.14|||Mixed Models Analysis|||||-35.14|-57.68|<.001
70924985|NCT05563246|141343097|SUPERIORITY||LS Mean Difference (Final Values)|-81.66|||<|0.001|TWO_SIDED|95.0|-84.62|-78.13|||Mixed Models Analysis|||||-78.13|-84.62|<.001
70924986|NCT05563246|141343097|SUPERIORITY||LS Mean Difference (Final Values)|-85.77|||<|0.001|TWO_SIDED|95.0|-88.03|-83.09|||Mixed Models Analysis|||||-83.09|-88.03|<.001
70924987|NCT05563246|141343098|SUPERIORITY||LS Mean Difference (Final Values)|-40.38|||<|0.001|TWO_SIDED|95.0|-50.45|-28.27|||Mixed Models Analysis|||||-28.27|-50.45|<.001
70924988|NCT05563246|141343098|SUPERIORITY||LS Mean Difference (Final Values)|-69.95|||<|0.001|TWO_SIDED|95.0|-74.23|-64.96|||Mixed Models Analysis|||||-64.96|-74.23|<.001
70924989|NCT05563246|141343098|SUPERIORITY||LS Mean Difference (Final Values)|-68.9|||<|0.001|TWO_SIDED|95.0|-73.27|-63.81|||Mixed Models Analysis|||||-63.81|-73.27|<.001
70924990|NCT05563246|141343099|SUPERIORITY||Risk Difference (RD)|58.15|||<|0.001|TWO_SIDED|95.0|40.3|75.99|||Regression, Logistic|||||75.99|40.30|<.001
70924991|NCT05563246|141343099|SUPERIORITY||Risk Difference (RD)|89.87|||<|0.001|TWO_SIDED|95.0|81.54|98.2|||Regression, Logistic|||||98.20|81.54|<.001
70924992|NCT05563246|141343099|SUPERIORITY||Risk Difference (RD)|90.71|||<|0.001|TWO_SIDED|95.0|82.8|98.62|||Regression, Logistic|||||98.62|82.80|<.001
70924993|NCT05563246|141343100|SUPERIORITY||Risk Difference (RD)|35.18|||<|0.001|TWO_SIDED|95.0|18.9|51.46|||Regression, Logistic|||||51.46|18.90|<.001
70924994|NCT05563246|141343100|SUPERIORITY||Risk Difference (RD)|78.18|||<|0.001|TWO_SIDED|95.0|67.7|88.65|||Regression, Logistic|||||88.65|67.70|<.001
70924995|NCT05563246|141343100|SUPERIORITY||Risk Difference (RD)|73.62|||<|0.001|TWO_SIDED|95.0|63.65|83.58|||Regression, Logistic|||||83.58|63.65|<.001
70924996|NCT05563246|141343101|SUPERIORITY||LS Mean Difference (Final Values)|-8.94||||0.11|TWO_SIDED|95.0|-18.84|2.17|||Mixed Models Analysis|||||2.17|-18.84|0.110
70924997|NCT05563246|141343101|SUPERIORITY||LS Mean Difference (Final Values)|-13.05||||0.004|TWO_SIDED|95.0|-20.92|-4.4|||Mixed Models Analysis|||||-4.40|-20.92|0.004
70924998|NCT05563246|141343101|SUPERIORITY||LS Mean Difference (Final Values)|-16.13|||<|0.001|TWO_SIDED|95.0|-23.69|-7.84|||Mixed Models Analysis|||||-7.84|-23.69|<.001
70924999|NCT05563246|141343102|SUPERIORITY||LS Mean Difference (Final Values)|35.27||||0.131|TWO_SIDED|95.0|-8.63|100.27|||Mixed Models Analysis|||||100.27|-8.63|0.131
70925000|NCT05563246|141343102|SUPERIORITY||LS Mean Difference (Final Values)|8.32||||0.627|TWO_SIDED|95.0|-21.62|49.7|||Mixed Models Analysis|||||49.70|-21.62|0.627
70925001|NCT05563246|141343102|SUPERIORITY||LS Mean Difference (Final Values)|-6.08||||0.701|TWO_SIDED|95.0|-31.89|29.51|||Mixed Models Analysis|||||29.51|-31.89|0.701
70925002|NCT02167867|141343106|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||t-test, 2 sided|||t=+7.76||||<0.0001
70925003|NCT03420833|141343116|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
71044064|NCT01833533|141597589|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|97.0|||||TWO_SIDED|95.0|93.7|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority.|Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides \>90% power to demonstrate superiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (75%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|93.7|
71044065|NCT01833533|141597589|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|90.2|||||TWO_SIDED|95.0|86.2|94.3|||||95% CI was calculated using the normal approximation to the binomial distribution; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority.|Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides \>90% power to demonstrate superiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (75%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||94.3|86.2|
70925004|NCT03420833|141343116|SUPERIORITY|||||||0.009|||||||t-test, 2 sided|||||||0.009
70925005|NCT03420833|141343119|SUPERIORITY|||||||0.024|||||||t-test, 2 sided|||||||0.024
70925006|NCT03420833|141343121|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
70925007|NCT03420833|141343121|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|||||||0.011
70925008|NCT03336333|141343133|SUPERIORITY||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.28|0.63||One-sided|Log Rank|||||0.63|0.28|<0.0001
71004622|NCT02614261|141517394|SUPERIORITY||Odds Ratio (OR)|1.819||||0.011|TWO_SIDED|95.0|1.146|2.888|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥75%||2.888|1.146|.011
71044066|NCT01833533|141597589|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Noninferiority of the rate of sustained virologic response at 12 weeks after treatment in the ABT-450/r/ABT-267 and ABT-333, plus placebo RBV treatment group as compared with the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group was analyzed using a noninferiority margin of -10.5%; the lower confidence bound of the 2-sided 95% CI (calculated using normal approximation to the binomial distribution)for the difference in percentage of participants must exceed -10.5% to achieve noninferiority.|Difference in Percentage of Participants|-6.8|||||TWO_SIDED|95.0|-12.0|-1.5|||||95% CI was calculated using the normal approximation to the binomial distribution.|Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides \>95% power to demonstrate noninferiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV arm compared with the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (normal approximation of a single binomial proportion in a one-sample test for superiority).||-1.5|-12.0|
70925009|NCT04650087|141343286|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.44|1.95||||||||1.95|0.44|
70925010|NCT04650087|141343287|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.83|1.31||||||||1.31|0.83|
70925011|NCT04650087|141343288|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.78|1.24||||||||1.24|0.78|
70925012|NCT04650087|141343289|SUPERIORITY||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.44|1.74||||||||1.74|0.44|
70925013|NCT04650087|141343290|SUPERIORITY||Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.58|2.12||||||||2.12|0.58|
70925014|NCT04650087|141343291|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.29|3.42||||||||3.42|0.29|
70925015|NCT04650087|141343292|SUPERIORITY||Risk Ratio (RR)|0.33|||||TWO_SIDED|95.0|0.03|3.18||||||||3.18|0.03|
70925016|NCT04650087|141343293|SUPERIORITY||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.34|2.28||||||||2.28|0.34|
71004623|NCT02614261|141517394|SUPERIORITY||Odds Ratio (OR)|0.761||||0.729|TWO_SIDED|95.0|0.163|3.563|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥100%||3.563|0.163|0.729
71004624|NCT02614261|141517394|SUPERIORITY||Odds Ratio (OR)|1.897||||0.276|TWO_SIDED|95.0|0.6|5.998|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥100%||5.998|0.600|.276
71004625|NCT02614261|141517395|SUPERIORITY||LSMean Difference|5.06|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|2.12|7.99|||Mixed Models Analysis|||||7.99|2.12|<.001
71044067|NCT03476317|141597614|EQUIVALENCE|Median difference in calprotectin for controls from day 12 to baseline||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
71044068|NCT01483625|141597622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0569|STANDARD_ERROR_OF_MEAN|0.055||0.3025|TWO_SIDED|95.0|-0.0516|0.1654|||Mixed effect repeated measures (MMRM)|Fixed effects:treatment,visit,treatment by visit,baseline and baseline by visit. Random:Patient. A spatial power covariance structure was used.||Tiotropium 18 mcg minus Placebo||0.1654|-0.0516|0.3025
70925017|NCT03039023|141343301|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.2||||||A p-value \<0.05 was considered significant.|Wilcoxon signed-rank test|||||||0.20
70925018|NCT03039023|141343301|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
70925019|NCT03039023|141343301|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
70925020|NCT03039023|141343301|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
70925021|NCT03039023|141343301|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.27||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.27
70925022|NCT03039023|141343302|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.1||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.10
70925023|NCT03039023|141343302|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.0002||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.0002
70925024|NCT03039023|141343302|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.01||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.01
70925025|NCT03039023|141343302|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.006||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.006
70925026|NCT03039023|141343302|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.79||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.79
70925027|NCT03039023|141343303|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.28||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.28
70925028|NCT03039023|141343303|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
71004626|NCT02614261|141517395|SUPERIORITY||LSMean Difference|6.29|STANDARD_ERROR_OF_MEAN|1.66|<|0.001|TWO_SIDED|95.0|3.03|9.55|||Mixed Models Analysis|||||9.55|3.03|<.001
70925029|NCT03039023|141343303|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
70925030|NCT03039023|141343303|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
70925031|NCT03039023|141343303|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.11||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.11
70925032|NCT03039023|141343304|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.005||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.005
70925033|NCT03039023|141343304|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.001
70925034|NCT03039023|141343304|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.001
70925035|NCT03039023|141343304|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.009||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.009
70925036|NCT03039023|141343304|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.04||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.04
71004627|NCT02614261|141517396|SUPERIORITY||LSMean Difference|-2.51|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|-3.27|-1.76|||Mixed Models Analysis|||||-1.76|-3.27|<.001
70925037|NCT03039023|141343305|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.93||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.93
70925038|NCT03039023|141343305|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.01||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.01
71004628|NCT02614261|141517396|SUPERIORITY||LSMean Difference|-2.01|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|-2.77|-1.26|||Mixed Models Analysis|||||-1.26|-2.77|<.001
71004629|NCT02614261|141517397|SUPERIORITY||LSMean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.1||0.181|TWO_SIDED|95.0|-0.34|0.06|||Mixed Models Analysis|||||0.06|-0.34|.181
71004630|NCT02614261|141517397|SUPERIORITY||LSMean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.1||0.006|TWO_SIDED|95.0|-0.48|-0.08|||Mixed Models Analysis|||||-0.08|-0.48|.006
71004631|NCT02614261|141517398|SUPERIORITY||LSMean Difference|-22.71|STANDARD_ERROR_OF_MEAN|4.6|<|0.001|TWO_SIDED|95.0|-31.74|-13.69|||Mixed Models Analysis|||||-13.69|-31.74|<.001
70925039|NCT03039023|141343305|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.003||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.003
70925040|NCT03039023|141343305|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.04||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.04
70925041|NCT03039023|141343305|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.99||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.99
70925042|NCT03039023|141343306|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.02||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.02
70925043|NCT03039023|141343306|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
70925044|NCT03039023|141343306|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
70925045|NCT03039023|141343306|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.001
70925046|NCT03039023|141343306|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.02||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.02
70925047|NCT04410042|141343350|EQUIVALENCE|Two-sided test at 0.05 level.||||||0.4|||||||Wilcoxon rank sum test|||||||0.4000
70925048|NCT04410042|141343351|EQUIVALENCE|Two-sided test at 0.05 level.||||||0.4286|||||||Wilcoxon rank sum test|||||||0.4286
70925049|NCT04410042|141343352|EQUIVALENCE|Two-sided test at 0.05 level.||||||0.9307|||||||Wilcoxon rank sum test|||||||0.9307
70925050|NCT04410042|141343353|EQUIVALENCE|Two-sided test at 0.05 level.||||||0.0714|||||||Wilcoxon rank sum test|||||||0.0714
70925051|NCT04410042|141343354|EQUIVALENCE|Two-sided test at 0.05 level.||||||0.9004|||||||Wilcoxon rank sum test|||||||0.9004
71004632|NCT02614261|141517398|SUPERIORITY||LSMean Difference|-18.09|STANDARD_ERROR_OF_MEAN|4.58|<|0.001|TWO_SIDED|95.0|-27.09|-9.09|||Mixed Models Analysis|||||-9.09|-27.09|<.001
71004633|NCT02614261|141517399|SUPERIORITY||LSMean Difference|-8.74|STANDARD_ERROR_OF_MEAN|3.9||0.025|TWO_SIDED|95.0|-16.39|-1.08|||ANCOVA|||||-1.08|-16.39|.025
71004634|NCT02614261|141517399|SUPERIORITY||LSMean Difference|-5.49|STANDARD_ERROR_OF_MEAN|3.88||0.157|TWO_SIDED|95.0|-13.1|2.12|||ANCOVA|||||2.12|-13.10|.157
71004635|NCT02614261|141517400|SUPERIORITY|||||||0.263|||||||Cochran-Mantel-Haenszel|||||||.263
71004636|NCT02614261|141517400|SUPERIORITY|||||||0.29|||||||Cochran-Mantel-Haenszel|||||||.290
71101424|NCT04003142|141710815|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.7||0.007|TWO_SIDED|95.0|-3.5|-0.6||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.6|-3.5|0.007
71101425|NCT04003142|141710816|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.4||0.001|TWO_SIDED|95.0|-2.09|-0.51||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.51|-2.09|0.001
71101426|NCT04003142|141710816|SUPERIORITY||LSMean difference|-1.71|STANDARD_ERROR_OF_MEAN|0.4|<|0.001||95.0|-2.51|-0.91||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.91|-2.51|<0.001
71101427|NCT04003142|141710816|SUPERIORITY||LSMean difference|-1.76|STANDARD_ERROR_OF_MEAN|0.45|<|0.001||95.0|-2.65|-0.87||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-0.87|-2.65|<0.001
71101428|NCT04003142|141710816|SUPERIORITY||LSMean difference|-1.97|STANDARD_ERROR_OF_MEAN|0.45|<|0.001||95.0|-2.86|-1.08||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-1.08|-2.86|<0.001
71101429|NCT04003142|141710816|SUPERIORITY||LSMean difference|-1.74|STANDARD_ERROR_OF_MEAN|0.46|<|0.001||95.0|-2.63|-0.84||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-0.84|-2.63|<0.001
71101430|NCT04003142|141710816|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.46|<|0.001||95.0|-3.29|-1.5||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-1.50|-3.29|<0.001
71101431|NCT04003142|141710816|SUPERIORITY||LSMean difference|-1.84|STANDARD_ERROR_OF_MEAN|0.48|<|0.001||95.0|-2.79|-0.9||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-0.90|-2.79|<0.001
71101432|NCT04003142|141710816|SUPERIORITY||LSMean difference|-2.66|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|-3.61|-1.72||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-1.72|-3.61|<0.001
71101433|NCT04003142|141710816|SUPERIORITY||LSMean difference|-1.78|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|-2.71|-0.85||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-0.85|-2.71|<0.001
71101434|NCT04003142|141710816|SUPERIORITY||LSMean difference|-2.66|STANDARD_ERROR_OF_MEAN|0.47|<|0.001||95.0|-3.59|-1.73||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-1.73|-3.59|<0.001
71101435|NCT04003142|141710816|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.49|<|0.001||95.0|-2.77|-0.83||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-0.83|-2.77|<0.001
71101436|NCT04003142|141710816|SUPERIORITY||LSMean difference|-2.34|STANDARD_ERROR_OF_MEAN|0.49|<|0.001||95.0|-3.3|-1.37||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-1.37|-3.30|<0.001
71101437|NCT04003142|141710816|SUPERIORITY||LSMean difference|-1.76|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|-2.79|-0.74||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-0.74|-2.79|<0.001
71101438|NCT04003142|141710816|SUPERIORITY||LSMean difference|-2.38|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|-3.4|-1.35||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-1.35|-3.40|<0.001
70925052|NCT03850678|141343359|SUPERIORITY|||||||0.774|||||||ANOVA|||This analysis examined Q10 for those participants who completed the compression speed experiment (instant, fast, slow).||||.774
70925053|NCT03850678|141343359|SUPERIORITY||||||<|0.001|||||||ANOVA|||This analysis examined Q10 for those participants who completed the compression channel conditions (4, 8, 16).||||<.001
71101439|NCT04003142|141710816|SUPERIORITY||LSMean difference|-1.65|STANDARD_ERROR_OF_MEAN|0.54||0.002||95.0|-2.71|-0.59||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-0.59|-2.71|0.002
70925054|NCT03850678|141343359|SUPERIORITY|||||||0.167|||||||ANOVA|||This analysis compared Q10 for those participants who completed the unaided and aided conditions.||||.167
70925055|NCT03850678|141343360|SUPERIORITY|||||||0.741|||||||ANOVA|||Statistical analysis of number of compression channels (unaided, 4 channel, 16 channels)||||.741
70925056|NCT03850678|141343360|SUPERIORITY|||||||0.062||||||Due to Levene's Test for Equality of Variances, equal variances were not assumed.|t-test, 1 sided|||Spatial Release from Masking, unaided.||||.062
71101440|NCT04003142|141710816|SUPERIORITY||LSMean difference|-2.51|STANDARD_ERROR_OF_MEAN|0.54|<|0.001||95.0|-3.57|-1.45||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-1.45|-3.57|<0.001
71101441|NCT04003142|141710816|SUPERIORITY||LSMean difference|-1.91|STANDARD_ERROR_OF_MEAN|0.54|<|0.001||95.0|-2.96|-0.86||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-0.86|-2.96|<0.001
71101442|NCT04003142|141710816|SUPERIORITY||LSMean difference|-2.65|STANDARD_ERROR_OF_MEAN|0.53|<|0.001||95.0|-3.69|-1.6||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-1.60|-3.69|<0.001
70925057|NCT03850678|141343361|SUPERIORITY|||||||0.805|||||||Regression, Linear|||Linear regression of score for the reading span (independent variable) to Q10 (dependent variable, 16 channel compression condition) for the participants who completed the compression channel experiment.||||.805
71004637|NCT02859558|141517436|SUPERIORITY|||||||0.48||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.||||0.48
71004638|NCT02859558|141517436|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||1
71004639|NCT02859558|141517436|SUPERIORITY|||||||0.5||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||0.50
71004640|NCT02859558|141517436|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Gag Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.||||1
71004641|NCT02859558|141517436|SUPERIORITY|||||||0.44||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Gag Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||0.44
71004642|NCT02859558|141517436|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Gag Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||1
71004643|NCT02859558|141517437|SUPERIORITY|||||||0.39||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.||||0.39
71004644|NCT02859558|141517437|SUPERIORITY|||||||0.46||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.||||0.46
71004645|NCT02859558|141517437|SUPERIORITY|||||||0.056||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.||||0.056
71044069|NCT01483625|141597623|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.99|STANDARD_ERROR_OF_MEAN|0.44||0.7823|TWO_SIDED|95.0|0.9053|1.078|||2sample t quantiles with pooled variance|||Comparison Tiotropium 18 mcg Vs Placebo||1.0780|0.9053|0.7823
71044070|NCT01483625|141597624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0099|STANDARD_ERROR_OF_MEAN|0.0806||0.9025|TWO_SIDED|95.0|-0.1489|0.1686||Comparison Tiotropium 18 mcg Vs Placebo at Week 12|Mixed effects repeated measures (MMRM)|Fixed effects:treatment,visit,treatment by visit,baseline and baseline by visit. Patient was random. A spatial power covariance structure was used.||||0.1686|-0.1489|0.9025
71044071|NCT01483625|141597627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.061|STANDARD_ERROR_OF_MEAN|3.0115||0.1797|TWO_SIDED|95.0|-10.0157|1.8938|||t-test, 2 sided|95% confidence interval is based on 2 sample t quantiles using pooled variance.||Comparison Tiotropium 18 mcg Vs Placebo Over 12 Weeks||1.8938|-10.0157|0.1797
71101443|NCT04003142|141710816|SUPERIORITY||LSMean difference|-1.86|STANDARD_ERROR_OF_MEAN|0.53|<|0.001||95.0|-2.91|-0.81||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-0.81|-2.91|<0.001
71101444|NCT04003142|141710816|SUPERIORITY||LSMean difference|-2.56|STANDARD_ERROR_OF_MEAN|0.53|<|0.001|TWO_SIDED|95.0|-3.61|-1.52||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-1.52|-3.61|<0.001
70925058|NCT03891667|141343365|SUPERIORITY||Odds Ratio (OR)|4.0|||||TWO_SIDED|95.0|0.21|75.66||||||||75.66|.21|
71004646|NCT02859558|141517437|SUPERIORITY|||||||0.025||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.||||0.025
71004647|NCT02859558|141517437|SUPERIORITY|||||||0.072||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.||||0.072
71004648|NCT02859558|141517437|SUPERIORITY|||||||0.47||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.||||0.47
71044072|NCT02310763|141597649|SUPERIORITY||Mean Difference (Net)|1.293|STANDARD_ERROR_OF_MEAN|1.022||0.2088|TWO_SIDED|95.0|-0.7343|3.32||The significance level is 0.05.|ANCOVA||Least square mean difference was calculated by placebo minus domagrozumab.|||3.3200|-0.7343|0.2088
71101445|NCT04003142|141710817|SUPERIORITY||LSMean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.04||0.001||95.0|-0.21|-0.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.05|-0.21|0.001
71101446|NCT04003142|141710817|SUPERIORITY||LSMean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|95.0|-0.24|-0.08||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.08|-0.24|<0.001
70925059|NCT03891667|141343366|SUPERIORITY||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.05|9.47||||||||9.47|0.05|
70925060|NCT00534469|141343376|OTHER|Two-sided test.||||||0.43||||||Log-rank test (Mantel-Haenszel test). This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Log Rank|||Null hypothesis: All four groups are drawn from the same distribution. Alternative hypothesis: At least one of the groups has measurably different survival from the others.||||0.43
70925061|NCT05717907|141343379|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.000
70925062|NCT04055090|141343437|OTHER||Least Square Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.438||0.046|TWO_SIDED|95.0|-1.76|-0.02|||Mixed Models Analysis|Mixed-effects Model for Repeated Measures (MMRM) with treatment, visit, treatment-by-visit, and use of gabapentin/pregabalin as main fixed effects|Mixed-effects Model for Repeated Measures with treatment, visit, treatment-by-visit, and use of gabapentin/pregabalin as main fixed effects. The Baseline average 24-hour pain score was included as a covariate.|||-0.02|-1.76|0.0460
70925063|NCT04055090|141343439|OTHER|||||||0.219|||||||Cochran-Mantel-Haenszel|||||||0.2190
70925064|NCT04055090|141343440|OTHER||Least-Squares Mean Difference|-1.48||||0.0155|TWO_SIDED|95.0|-2.67|-0.29|||Mixed Models Analysis||Mixed-effects Model for Repeated Measures (MMRM) with treatment, visit, treatment-by-visit, and use of gabapentin/pregabalin as main fixed effects. Baseline average 24-hour pain score is included as a covariate.|||-0.29|-2.67|0.0155
70925065|NCT05093829|141343453|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup A if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.0|2.0||||||For serogroup A, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||2.0|-1.0|
70925066|NCT05093829|141343453|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup A if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|0.8|||||TWO_SIDED|95.0|-0.6|3.7||||||For serogroup A, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||3.7|-0.6|
70925067|NCT05093829|141343453|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup C if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|-0.5|||||TWO_SIDED|95.0|-2.3|1.9||||||For serogroup C, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||1.9|-2.3|
70925068|NCT05093829|141343453|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup C if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|-0.8|||||TWO_SIDED|95.0|-3.3|2.5||||||For serogroup C, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||2.5|-3.3|
71101447|NCT04003142|141710817|SUPERIORITY||LSMean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.05||0.001||95.0|-0.28|-0.07||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-0.07|-0.28|0.001
70925069|NCT05093829|141343453|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup W if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|-3.0|||||TWO_SIDED|95.0|-6.3|0.8||||||For serogroup W, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||0.8|-6.3|
70925070|NCT05093829|141343453|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup W if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|0.3|||||TWO_SIDED|95.0|-1.8|3.5||||||For serogroup W, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||3.5|-1.8|
71004649|NCT02859558|141517437|SUPERIORITY|||||||0.086||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.||||0.086
71004650|NCT02859558|141517437|SUPERIORITY|||||||0.18||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.||||0.18
71004651|NCT02859558|141517437|SUPERIORITY|||||||0.88||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.||||0.88
70925071|NCT05093829|141343453|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup Y if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|-3.0|||||TWO_SIDED|95.0|-5.4|-0.4||||||For serogroup Y, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||-0.4|-5.4|
70925072|NCT05093829|141343453|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup Y if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|1.4|||||TWO_SIDED|95.0|-0.6|4.8||||||For serogroup Y, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||4.8|-0.6|
70925073|NCT05093829|141343454|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup X if the lower limit of the 95% confidence interval (CI) for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). The CI is estimated using bootstrap resampling stratified by vaccine arm, and the 95% CI is estimated as the interval between the 2.5th and 97.5th percentiles of the bootstrap empirical distribution. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|2.3|||||TWO_SIDED|95.0|0.3|4.7||||||For the 9-months study age group, the proportion of infants with a seroprotective response to MenACWY-TT in serogroup W is subtracted from the proportion of infants with a seroprotective response to NmCV-5 in serogroup X to determine the difference in proportions.||4.7|0.3|
70925074|NCT05093829|141343454|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup X if the lower limit of the 95% confidence interval (CI) for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). The CI is estimated using bootstrap resampling stratified by vaccine arm, and the 95% CI is estimated as the interval between the 2.5th and 97.5th percentiles of the bootstrap empirical distribution. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|1.9|||||TWO_SIDED|95.0|0.004|4.4||||||For the 15-months study age group, the proportion of infants with a seroprotective response to MenACWY-TT in serogroup Y is subtracted from the proportion of infants with a seroprotective response to NmCV-5 in serogroup X to determine the difference in proportions.||4.4|0.004|
71101448|NCT04003142|141710817|SUPERIORITY||LSMean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.05||0.001|TWO_SIDED|95.0|-0.28|-0.07||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-0.07|-0.28|0.001
71101449|NCT04003142|141710817|SUPERIORITY||LSMean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.067||95.0|-0.23|0.01||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||0.01|-0.23|0.067
71101450|NCT04003142|141710817|SUPERIORITY||LSMean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.35|-0.11||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-0.11|-0.35|<0.001
71101451|NCT04003142|141710817|SUPERIORITY||LSMean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.02|TWO_SIDED|95.0|-0.3|-0.03||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-0.03|-0.30|0.020
71101452|NCT04003142|141710817|SUPERIORITY||LSMean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.43|-0.16||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-0.16|-0.43|<0.001
71004652|NCT02859558|141517437|SUPERIORITY|||||||0.061||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.||||0.061
71101453|NCT04003142|141710817|SUPERIORITY||LSMean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.07||0.012|TWO_SIDED|95.0|-0.32|-0.04||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-0.04|-0.32|0.012
71101454|NCT04003142|141710817|SUPERIORITY||LSMean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.07|<|0.001||95.0|-0.42|-0.14||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-0.14|-0.42|<0.001
70925075|NCT05093829|141343458|SUPERIORITY|NmCV-5 will be deemed superior to MenACWY-TT for serogroup X if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes 0.30 (30%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|82.5|||||TWO_SIDED|95.0|76.4|87.2||||||For serogroup X, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||87.2|76.4|
70925076|NCT05093829|141343458|SUPERIORITY|NmCV-5 will be deemed superior to MenACWY-TT for serogroup X if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes 0.30 (30%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|68.4|||||TWO_SIDED|95.0|61.3|74.7||||||For serogroup X, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||74.7|61.3|
70925077|NCT05093829|141343459|NON_INFERIORITY|The NmCV-5 co-administered MR vaccine will be deemed non-inferior to the MenACWY-TT co-administered MR vaccine in eliciting seropositive response to measles if the lower limit of the 95% confidence interval for the difference in proportions excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.0|2.0||||||For this comparison, the proportion of infants with a seropositive response to measles vaccine in the MenACWY-TT arm is subtracted from the proportion of infants with a seropositive response to measles vaccine in the NmCV-5 arm to determine the difference in proportions.||2.0|-1.0|
70925078|NCT05093829|141343459|NON_INFERIORITY|The NmCV-5 co-administered MR vaccine will be deemed non-inferior to the MenACWY-TT co-administered MR vaccine in eliciting seropositive response to measles if the lower limit of the 95% confidence interval for the difference in proportions excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.0|2.1||||||For this comparison, the proportion of infants with a seropositive response to measles vaccine in the MenACWY-TT arm is subtracted from the proportion of infants with a seropositive response to measles vaccine in the NmCV-5 arm to determine the difference in proportions.||2.1|-1.0|
71044073|NCT02310763|141597653|SUPERIORITY||Mean Difference (Net)|-0.0845||||0.9191|TWO_SIDED|95.0|-1.7354|1.5663||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||1.5663|-1.7354|0.9191
70925079|NCT05093829|141343460|NON_INFERIORITY|The NmCV-5 co-administered MR vaccine will be deemed non-inferior to the MenACWY-TT co-administered MR vaccine in eliciting seropositive response to rubella if the lower limit of the 95% confidence interval for the difference in proportions excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|-4.3|||||TWO_SIDED|95.0|-10.5|2.6||||||For this comparison, the proportion of infants with a seropositive response to rubella vaccine in the MenACWY-TT arm is subtracted from the proportion of infants with a seropositive response to rubella vaccine in the NmCV-5 arm to determine the difference in proportions.||2.6|-10.5|
70925080|NCT05093829|141343460|NON_INFERIORITY|The NmCV-5 co-administered MR vaccine will be deemed non-inferior to the MenACWY-TT co-administered MR vaccine in eliciting seropositive response to rubella if the lower limit of the 95% confidence interval for the difference in proportions excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.0|2.1||||||For this comparison, the proportion of infants with a seropositive response to rubella vaccine in the MenACWY-TT arm is subtracted from the proportion of infants with a seropositive response to rubella vaccine in the NmCV-5 arm to determine the difference in proportions.||2.1|-1.0|
70925081|NCT05093829|141343461|NON_INFERIORITY|The NmCV-5 co-administered yellow fever vaccine will be deemed non-inferior to the MenACWY-TT co-administered yellow fever vaccine in eliciting seroprotective response to yellow fever if the lower limit of the 95% confidence interval for the difference in proportions excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|-1.9|||||TWO_SIDED|95.0|-4.2|0.6||||||For this comparison, the proportion of infants with a seroprotective response to yellow fever vaccine in the MenACWY-TT arm is subtracted from the proportion of infants with a seroprotective response to yellow fever vaccine in the NmCV-5 arm to determine the difference in proportions.||0.6|-4.2|
71044074|NCT02310763|141597653|SUPERIORITY||Mean Difference (Net)|0.5837||||0.7642|TWO_SIDED|95.0|-3.2978|4.4652||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||4.4652|-3.2978|0.7642
70925082|NCT05093829|141343462|OTHER||Ratio of geometric mean titers|1.0|||||TWO_SIDED|95.0|0.8|1.3|||||NmCV-5 divided by MenACWY-TT|For serogroup A, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1.3|0.8|
70925083|NCT05093829|141343462|OTHER||Ratio of geometric mean titers|1.2|||||TWO_SIDED|95.0|1.0|1.6|||||NmCV-5 divided by MenACWY-TT|For serogroup A, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1.6|1.0|
70925084|NCT05093829|141343462|OTHER||Ratio of geometric mean titers|0.5|||||TWO_SIDED|95.0|0.4|0.6|||||NmCV-5 divided by MenACWY-TT|For serogroup C, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||0.6|0.4|
70925085|NCT05093829|141343462|OTHER||Ratio of geometric mean titers|0.4|||||TWO_SIDED|95.0|0.3|0.5|||||NmCV-5 divided by MenACWY-TT|For serogroup C, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||0.5|0.3|
71004653|NCT02859558|141517437|SUPERIORITY|||||||0.042||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.||||0.042
71004654|NCT02859558|141517437|SUPERIORITY|||||||0.54||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.||||0.54
71044075|NCT02310763|141597653|SUPERIORITY||Mean Difference (Net)|0.2712||||0.9423|TWO_SIDED|95.0|-7.3799|7.9223||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49||7.9223|-7.3799|0.9423
71044076|NCT02310763|141597654|SUPERIORITY||Mean Difference (Net)|0.0||||0.9993|TWO_SIDED|95.0|-0.0693|0.0693||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||0.0693|-0.0693|0.9993
71101455|NCT04003142|141710817|SUPERIORITY||LSMean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.03|TWO_SIDED|95.0|-0.31|-0.02||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-0.02|-0.31|0.030
71101456|NCT04003142|141710817|SUPERIORITY||LSMean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.43|-0.14||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-0.14|-0.43|<0.001
71101457|NCT04003142|141710817|SUPERIORITY||LSMean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.08||0.095|TWO_SIDED|95.0|-0.28|0.02||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||0.02|-0.28|0.095
71101458|NCT04003142|141710817|SUPERIORITY||LSMean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.41|-0.11||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-0.11|-0.41|<0.001
71101459|NCT04003142|141710817|SUPERIORITY||LSMean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.08||0.109|TWO_SIDED|95.0|-0.28|0.03||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||0.03|-0.28|0.109
71101460|NCT04003142|141710817|SUPERIORITY||LSMean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.43|-0.12||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-0.12|-0.43|<0.001
71101461|NCT04003142|141710817|SUPERIORITY||LSMean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.08||0.02||95.0|-0.35|-0.03||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-0.03|-0.35|0.020
71101462|NCT04003142|141710817|SUPERIORITY||LSMean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.08|<|0.001||95.0|-0.47|-0.15||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-0.15|-0.47|<0.001
71101463|NCT04003142|141710817|SUPERIORITY||LSMean diferrence|-0.21|STANDARD_ERROR_OF_MEAN|0.08||0.012||95.0|-0.37|-0.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-0.05|-0.37|0.012
71004655|NCT02859558|141517438|SUPERIORITY|||||||0.97||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.||||0.97
71004656|NCT02859558|141517438|SUPERIORITY|||||||0.21||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.||||0.21
71004657|NCT02859558|141517438|SUPERIORITY|||||||0.12||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.||||0.12
71004658|NCT02859558|141517438|SUPERIORITY|||||||0.055||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.||||0.055
71004659|NCT02859558|141517438|SUPERIORITY|||||||0.28||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.||||0.28
71004660|NCT02859558|141517438|SUPERIORITY|||||||0.38||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.||||0.38
71004661|NCT02859558|141517438|SUPERIORITY|||||||0.35||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.||||0.35
71004662|NCT02859558|141517438|SUPERIORITY|||||||0.007||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.||||0.007
71101464|NCT04003142|141710817|SUPERIORITY||LSMean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.08|<|0.001||95.0|-0.47|-0.15||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-0.15|-0.47|<0.001
71101465|NCT04003142|141710818|SUPERIORITY||LSMean difference|-12.16|STANDARD_ERROR_OF_MEAN|3.43|<|0.001||95.0|-18.9|-5.43||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-5.43|-18.90|<0.001
70925086|NCT05093829|141343462|OTHER||Ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.6|1.3|||||NmCV-5 divided by MenACWY-TT|For serogroup W, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1.3|0.6|
70925087|NCT05093829|141343462|OTHER||Ratio of geometric mean titers|1.6|||||TWO_SIDED|95.0|1.1|2.1|||||NmCV-5 divided by MenACWY-TT|For serogroup W, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||2.1|1.1|
70925088|NCT05093829|141343462|OTHER||Ratio of geometric mean titers|0.7|||||TWO_SIDED|95.0|0.6|1.0|||||NmCV-5 divided by MenACWY-TT|For serogroup Y, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1.0|0.6|
70925089|NCT05093829|141343462|OTHER||Ratio of geometric mean titers|1.0|||||TWO_SIDED|95.0|0.8|1.3|||||NmCV-5 divided by MenACWY-TT|For serogroup Y, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1.3|0.8|
70925090|NCT05093829|141343462|OTHER||Ratio of geometric mean titers|1511.1|||||TWO_SIDED|95.0|1169.5|1952.4|||||NmCV-5 divided by MenACWY-TT|For serogroup X, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1952.4|1169.5|
70925091|NCT05093829|141343462|OTHER||Ratio of geometric mean titers|767.3|||||TWO_SIDED|95.0|553.2|1064.4|||||NmCV-5 divided by MenACWY-TT|For serogroup X, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1064.4|553.2|
70925092|NCT05093829|141343464|OTHER||Ratio of geometric mean titers|2756.4|||||TWO_SIDED|95.0|1976.3|3844.5|||||Day 29 divided by Day 1|For serogroup A, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||3844.5|1976.3|
70925093|NCT05093829|141343464|OTHER||Ratio of geometric mean titers|2506.9|||||TWO_SIDED|95.0|1404.0|4476.1|||||Day 29 divided by Day 1|For serogroup A, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||4476.1|1404.0|
70925094|NCT05093829|141343464|OTHER||Ratio of geometric mean titers|1179.0|||||TWO_SIDED|95.0|709.8|1958.6|||||Day 29 divided by Day 1|For serogroup A, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||1958.6|709.8|
70925095|NCT05093829|141343464|OTHER||Ratio of geometric mean titers|1096.2|||||TWO_SIDED|95.0|513.4|2340.6|||||Day 29 divided by Day 1|For serogroup A, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||2340.6|513.4|
70925096|NCT05093829|141343464|OTHER||Ratio of geometric mean titers|288.7|||||TWO_SIDED|95.0|212.6|392.0|||||Day 29 divided by Day 1|For serogroup C, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||392.0|212.6|
70925097|NCT05093829|141343464|OTHER||Ratio of geometric mean titers|654.5|||||TWO_SIDED|95.0|385.5|1111.0|||||Day 29 divided by Day 1|For serogroup C, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||1111.0|385.5|
70925098|NCT05093829|141343464|OTHER||Ratio of geometric mean titers|287.9|||||TWO_SIDED|95.0|213.9|387.5|||||Day 29 divided by Day 1|For serogroup C, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||387.5|213.9|
71004663|NCT02859558|141517438|SUPERIORITY|||||||0.045||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.||||0.045
70925099|NCT05093829|141343464|OTHER||Ratio of geometric mean titers|834.6|||||TWO_SIDED|95.0|496.7|1402.3|||||Day 29 divided by Day 1|For serogroup C, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||1402.3|496.7|
70925100|NCT05093829|141343464|OTHER||Ratio of geometric mean titers|1068.4|||||TWO_SIDED|95.0|683.3|1670.6|||||Day 29 divided by Day 1|For serogroup W, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||1670.6|683.3|
71044077|NCT02310763|141597654|SUPERIORITY||Mean Difference (Net)|-0.0259||||0.5464|TWO_SIDED|95.0|-0.1107|0.0589||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||0.0589|-0.1107|0.5464
71004664|NCT02859558|141517438|SUPERIORITY|||||||0.085||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.||||0.085
71004665|NCT02859558|141517438|SUPERIORITY|||||||0.044||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.||||0.044
71101466|NCT04003142|141710818|SUPERIORITY||LSMean difference|-15.68|STANDARD_ERROR_OF_MEAN|3.44|<|0.001||95.0|-22.44|-8.91||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-8.91|-22.44|<0.001
71101467|NCT04003142|141710818|SUPERIORITY||LSMean difference|-14.61|STANDARD_ERROR_OF_MEAN|3.81|<|0.001|TWO_SIDED|95.0|-22.09|-7.13||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-7.13|-22.09|<0.001
71101468|NCT04003142|141710818|SUPERIORITY||LSMean difference|-15.95|STANDARD_ERROR_OF_MEAN|3.82|<|0.001|TWO_SIDED|95.0|-23.45|-8.45||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-8.45|-23.45|<0.001
71101469|NCT04003142|141710818|SUPERIORITY||LSMean difference|-15.51|STANDARD_ERROR_OF_MEAN|3.89|<|0.001||95.0|-23.16|-7.86||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-7.86|-23.16|<0.001
71101470|NCT04003142|141710818|SUPERIORITY||LSMean difference|-20.25|STANDARD_ERROR_OF_MEAN|3.9|<|0.001||95.0|-27.91|-12.59||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-12.59|-27.91|<0.001
71101471|NCT04003142|141710818|SUPERIORITY||LSMean difference|-16.34|STANDARD_ERROR_OF_MEAN|3.92|<|0.001||95.0|-24.04|-8.63||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 4||-8.63|-24.04|<0.001
71101472|NCT04003142|141710818|SUPERIORITY||LSMean difference|-21.65|STANDARD_ERROR_OF_MEAN|3.92|<|0.001||95.0|-29.36|-13.94||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 4||-13.94|-29.36|<0.001
71101473|NCT04003142|141710818|SUPERIORITY||LSMean difference|-15.62|STANDARD_ERROR_OF_MEAN|3.89|<|0.001|TWO_SIDED|95.0|-23.27|-7.98||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-7.98|-23.27|<0.001
71101474|NCT04003142|141710818|SUPERIORITY||LSMean difference|-22.88|STANDARD_ERROR_OF_MEAN|3.89|<|0.001||95.0|-30.52|-15.24||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-15.24|-30.52|<0.001
71101475|NCT04003142|141710818|SUPERIORITY||LSMean difference|-14.78|STANDARD_ERROR_OF_MEAN|3.87|<|0.001||95.0|-22.38|-7.19||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-7.19|-22.38|<0.001
71101476|NCT04003142|141710818|SUPERIORITY||LSMean difference|-22.66|STANDARD_ERROR_OF_MEAN|3.86|<|0.001|TWO_SIDED|95.0|-30.25|-15.07||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-15.07|-30.25|<0.001
71101477|NCT04003142|141710818|SUPERIORITY||LSMean difference|-14.97|STANDARD_ERROR_OF_MEAN|4.01|<|0.001|TWO_SIDED|95.0|-22.86|-7.09||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-7.09|-22.86|<0.001
71101478|NCT04003142|141710818|SUPERIORITY||LSMean difference|-21.47|STANDARD_ERROR_OF_MEAN|4.01|<|0.001||95.0|-29.34|-13.6||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-13.60|-29.34|<0.001
71101479|NCT04003142|141710818|SUPERIORITY||LSMean difference|-14.38|STANDARD_ERROR_OF_MEAN|4.05|<|0.001|TWO_SIDED|95.0|-22.33|-6.43||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-6.43|-22.33|<0.001
71101480|NCT04003142|141710818|SUPERIORITY||LSMean difference|-20.57|STANDARD_ERROR_OF_MEAN|4.03|<|0.001||95.0|-28.5|-12.65||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-12.65|-28.50|<0.001
71101481|NCT04003142|141710818|SUPERIORITY||LSMean difference|-12.14|STANDARD_ERROR_OF_MEAN|4.07||0.003||95.0|-20.14|-4.14||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-4.14|-20.14|0.003
70925101|NCT05093829|141343464|OTHER||Ratio of geometric mean titers|1933.1|||||TWO_SIDED|95.0|1224.7|3051.1|||||Day 29 divided by Day 1|For serogroup W, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||3051.1|1224.7|
70925102|NCT05093829|141343464|OTHER||Ratio of geometric mean titers|3163.1|||||TWO_SIDED|95.0|2247.5|4451.7|||||Day 29 divided by Day 1|For serogroup W, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||4451.7|2247.5|
70925103|NCT05093829|141343464|OTHER||Ratio of geometric mean titers|1524.1|||||TWO_SIDED|95.0|913.5|2543.0|||||Day 29 divided by Day 1|For serogroup W, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||2543.0|913.5|
71004666|NCT02859558|141517438|SUPERIORITY|||||||0.6||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.||||0.60
71044078|NCT02310763|141597654|SUPERIORITY||Mean Difference (Net)|-0.042||||0.3041|TWO_SIDED|95.0|-0.1227|0.0386||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49||0.0386|-0.1227|0.3041
70925104|NCT05093829|141343464|OTHER||Ratio of geometric mean titers|799.4|||||TWO_SIDED|95.0|532.9|1199.4|||||Day 29 divided by Day 1|For serogroup Y, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||1199.4|532.9|
71044079|NCT02310763|141597655|SUPERIORITY||Mean Difference (Net)|0.8||||0.3522|TWO_SIDED|95.0|-0.9|2.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||2.5|-0.9|0.3522
71004667|NCT02859558|141517439|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Joint Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.||||1
71004668|NCT02859558|141517439|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Joint Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||1
71044080|NCT02310763|141597655|SUPERIORITY||Mean Difference (Net)|2.5||||0.0061|TWO_SIDED|95.0|0.7|4.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||4.2|0.7|0.0061
71044081|NCT02310763|141597655|SUPERIORITY|Week 49|Mean Difference (Net)|1.6||||0.1268|TWO_SIDED|95.0|-0.5|3.8||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|||3.8|-0.5|0.1268
71044082|NCT02310763|141597656|SUPERIORITY||Mean Difference (Net)|-0.4||||0.7337|TWO_SIDED|95.0|-2.9|2.1||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left ankle, Week 17||2.1|-2.9|0.7337
71044083|NCT02310763|141597656|SUPERIORITY||Mean Difference (Net)|0.2||||0.8893|TWO_SIDED|95.0|-2.4|2.7||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left ankle, Week 33||2.7|-2.4|0.8893
71044084|NCT02310763|141597656|SUPERIORITY||Mean Difference (Net)|-1.5||||0.2939|TWO_SIDED|95.0|-4.3|1.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left ankle, Week 49||1.3|-4.3|0.2939
71044085|NCT02310763|141597656|SUPERIORITY||Mean Difference (Net)|0.8||||0.5995|TWO_SIDED|95.0|-2.1|3.6||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right ankle, Week 17||3.6|-2.1|0.5995
71044086|NCT02310763|141597656|SUPERIORITY||Mean Difference (Net)|2.9||||0.0385|TWO_SIDED|95.0|0.2|5.6||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right ankle, Week 33||5.6|0.2|0.0385
71044087|NCT02310763|141597656|SUPERIORITY||Mean Difference (Net)|0.0||||0.9927|TWO_SIDED|95.0|-3.3|3.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right ankle, Week 49||3.2|-3.3|0.9927
71044088|NCT02310763|141597657|SUPERIORITY||Mean Difference (Net)|-0.3||||0.6049|TWO_SIDED|95.0|-1.7|1.0||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||1.0|-1.7|0.6049
71044089|NCT02310763|141597657|SUPERIORITY||Mean Difference (Net)|1.7||||0.2065|TWO_SIDED|95.0|-1.0|4.4||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||4.4|-1.0|0.2065
71044090|NCT02310763|141597657|SUPERIORITY||Mean Difference (Net)|0.0||||0.9391|TWO_SIDED|95.0|-1.3|1.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49||1.2|-1.3|0.9391
71044091|NCT02310763|141597658|SUPERIORITY||Mean Difference (Net)|1.8||||0.8499|TWO_SIDED|95.0|-16.7|20.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||20.3|-16.7|0.8499
70925105|NCT05093829|141343464|OTHER||Ratio of geometric mean titers|1469.2|||||TWO_SIDED|95.0|995.3|2168.8|||||Day 29 divided by Day 1|For serogroup Y, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||2168.8|995.3|
71004669|NCT02859558|141517439|SUPERIORITY|||||||0.64||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.||||0.64
70925106|NCT05093829|141343464|OTHER||Ratio of geometric mean titers|549.4|||||TWO_SIDED|95.0|371.8|811.8|||||Day 29 divided by Day 1|For serogroup Y, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||811.8|371.8|
70925107|NCT05093829|141343464|OTHER||Ratio of geometric mean titers|642.6|||||TWO_SIDED|95.0|309.2|1335.9|||||Day 29 divided by Day 1|For serogroup Y, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||1335.9|309.2|
70925108|NCT05093829|141343464|OTHER||Ratio of geometric mean titers|2630.0|||||TWO_SIDED|95.0|2037.6|3394.6|||||Day 29 divided by Day 1|For serogroup X, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||3394.6|2037.6|
70925109|NCT05093829|141343464|OTHER||Ratio of geometric mean titers|2.0|||||TWO_SIDED|95.0|1.2|3.4|||||Day 29 divided by Day 1|For serogroup X, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||3.4|1.2|
70925110|NCT05093829|141343464|OTHER||Ratio of geometric mean titers|1431.2|||||TWO_SIDED|95.0|905.2|2262.9|||||Day 29 divided by Day 1|For serogroup X, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||2262.9|905.2|
70925111|NCT05093829|141343464|OTHER||Ratio of geometric mean titers|1.7|||||TWO_SIDED|95.0|0.9|3.3|||||Day 29 divided by Day 1|For serogroup X, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||3.3|0.9|
70925112|NCT02995434|141343518|EQUIVALENCE|As reliable estimates of expected effect size were unknown, the study was powered to detect a medium effect (0.5 SD change), considered a reasonable clinically meaningful impact to obtain 80% power based on a repeated measures analysis of variance (RM ANOVA) with 2-tailed alpha of .05 model.|Mean Difference (Net)|-2.08|||||TWO_SIDED|95.0|-3.86|-0.3|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|Null hypothesis: There is no difference between the reported daily pain experiences of participants during, or after exposure to VR immersive environments, overall and within four different VR immersive environments, compared to the equivalent applications experienced on a 2D computer screen.||-0.30|-3.86|
70925113|NCT02995434|141343518|EQUIVALENCE|As reliable estimates of expected effect size were unknown, the study was powered to detect a medium effect (0.5 SD change), considered a reasonable clinically meaningful impact to obtain 80% power based on a repeated measures analysis of variance (RM ANOVA) with 2-tailed alpha of .05 model|Mean Difference (Net)|0.53|||||TWO_SIDED|95.0|-1.24|2.37|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||2.37|-1.24|
71044092|NCT02310763|141597658|SUPERIORITY||Mean Difference (Net)|8.9||||0.4008|TWO_SIDED|95.0|-12.0|29.8||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||29.8|-12.0|0.4008
71044093|NCT02310763|141597658|SUPERIORITY||Mean Difference (Net)|-1.5||||0.916|TWO_SIDED|95.0|-30.0|27.0||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49||27.0|-30.0|0.9160
71101482|NCT04003142|141710818|SUPERIORITY||LSMean difference|-19.73|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-27.71|-11.755||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-11.755|-27.71|<0.001
70925114|NCT02995434|141343519|EQUIVALENCE|See section for primary outcome.|Mean Difference (Net)|1.08|||||TWO_SIDED|95.0|-1.59|3.95|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||3.95|-1.59|
70925115|NCT02995434|141343519|EQUIVALENCE|See section on primary outcome|Mean Difference (Net)|2.16|||||TWO_SIDED|95.0|-0.55|5.08|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||5.08|-0.55|
70925116|NCT02995434|141343519|EQUIVALENCE|See section on primary outcome|Mean Difference (Net)|0.39|||||TWO_SIDED|95.0|-2.64|3.42|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||3.42|-2.64|
70925117|NCT02995434|141343519|EQUIVALENCE|See section on primary outcome|Mean Difference (Net)|2.56|||||TWO_SIDED|95.0|-0.08|5.48|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||5.48|-0.08|
70925118|NCT02995434|141343520|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|0.37|||||TWO_SIDED|95.0|-0.71|1.5|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||1.5|-0.71|
71044094|NCT02310763|141597659|SUPERIORITY||Mean Difference (Net)|0.115||||0.5726|TWO_SIDED|95.0|-0.287|0.517||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow extension, Week 17||0.517|-0.287|0.5726
71044095|NCT02310763|141597659|SUPERIORITY||Mean Difference (Net)|-0.163||||0.4334|TWO_SIDED|95.0|-0.574|0.248||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow extension, Week 33||0.248|-0.574|0.4334
71044096|NCT02310763|141597659|SUPERIORITY||Mean Difference (Net)|-0.126||||0.5767|TWO_SIDED|95.0|-0.573|0.321||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow extension, Week 49||0.321|-0.573|0.5767
71101483|NCT04003142|141710818|SUPERIORITY||LSMean difference|-14.4|STANDARD_ERROR_OF_MEAN|4.0|<|0.001|TWO_SIDED|95.0|-22.25|-6.54||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-6.54|-22.25|<0.001
71004670|NCT02859558|141517439|SUPERIORITY|||||||0.69||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||0.69
71004671|NCT02859558|141517439|SUPERIORITY|||||||0.4||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||0.40
71004672|NCT02859558|141517439|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Gag Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.||||1
71044097|NCT02310763|141597659|SUPERIORITY||Mean Difference (Net)|-0.022||||0.9274|TWO_SIDED|95.0|-0.489|0.446||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow extension, Week 17||0.446|-0.489|0.9274
71044098|NCT02310763|141597659|SUPERIORITY||Mean Difference (Net)|-0.439||||0.0469|TWO_SIDED|95.0|-0.872|-0.006||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow extension, Week 33||-0.006|-0.872|0.0469
71044099|NCT02310763|141597659|SUPERIORITY||Mean Difference (Net)|-0.166||||0.4362|TWO_SIDED|95.0|-0.587|0.255||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow extension, Week 49||0.255|-0.587|0.4362
71044100|NCT02310763|141597660|SUPERIORITY||Mean Difference (Net)|-0.156||||0.5557|TWO_SIDED|95.0|-0.679|0.367||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow flexion, Week 17||0.367|-0.679|0.5557
71044101|NCT02310763|141597660|SUPERIORITY||Mean Difference (Net)|-0.303||||0.2669|TWO_SIDED|95.0|-0.841|0.235||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow flexion, Week 33||0.235|-0.841|0.2669
71044102|NCT02310763|141597660|SUPERIORITY||Mean Difference (Net)|-0.161||||0.4665|TWO_SIDED|95.0|-0.598|0.276||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow flexion, Week 49||0.276|-0.598|0.4665
71044103|NCT02310763|141597660|SUPERIORITY||Mean Difference (Net)|-0.083||||0.7335|TWO_SIDED|95.0|-0.564|0.399||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow flexion, Week 17||0.399|-0.564|0.7335
71044104|NCT02310763|141597660|SUPERIORITY||Mean Difference (Net)|-0.361||||0.1695|TWO_SIDED|95.0|-0.877|0.156||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow flexion, Week 33||0.156|-0.877|0.1695
71044105|NCT02310763|141597660|SUPERIORITY||Mean Difference (Net)|-0.189||||0.3783|TWO_SIDED|95.0|-0.612|0.234||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow flexion, Week 49||0.234|-0.612|0.3783
71044106|NCT02310763|141597661|SUPERIORITY||Mean Difference (Net)|-0.586||||0.1078|TWO_SIDED|95.0|-1.303|0.13||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left hip abduction, Week 17||0.130|-1.303|0.1078
71044107|NCT02310763|141597661|SUPERIORITY||Mean Difference (Net)|0.046||||0.8967|TWO_SIDED|95.0|-0.654|0.746||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left hip abduction, Week 33||0.746|-0.654|0.8967
71004673|NCT02859558|141517439|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Gag Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||1
71044108|NCT02310763|141597661|SUPERIORITY||Mean Difference (Net)|-0.378||||0.3196|TWO_SIDED|95.0|-1.128|0.371||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left hip abduction, Week 49||0.371|-1.128|0.3196
71044109|NCT02310763|141597661|SUPERIORITY||Mean Difference (Net)|-0.689||||0.0526|TWO_SIDED|95.0|-1.386|0.008||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right hip abduction, Week 17||0.008|-1.386|0.0526
71044110|NCT02310763|141597661|SUPERIORITY||Mean Difference (Net)|-0.336||||0.3739|TWO_SIDED|95.0|-1.082|0.41||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right hip abduction, Week 33||0.410|-1.082|0.3739
71044111|NCT02310763|141597661|SUPERIORITY||Mean Difference (Net)|-0.322||||0.4019|TWO_SIDED|95.0|-1.079|0.436||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right hip abduction, Week 49||0.436|-1.079|0.4019
71044112|NCT02310763|141597662|SUPERIORITY||Mean Difference (Net)|-0.107||||0.7676|TWO_SIDED|95.0|-0.825|0.61||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left knee extension, Week 17||0.610|-0.825|0.7676
71044113|NCT02310763|141597662|SUPERIORITY||Mean Difference (Net)|-0.322||||0.4127|TWO_SIDED|95.0|-1.098|0.454||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left knee extension, Week 33||0.454|-1.098|0.4127
71044114|NCT02310763|141597662|SUPERIORITY||Mean Difference (Net)|0.113||||0.7815|TWO_SIDED|95.0|-0.693|0.919||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left knee extension, Week 49||0.919|-0.693|0.7815
71004674|NCT05665595|141517440|OTHER||Hazard Ratio (HR)|1.25|||||TWO_SIDED|95.0|0.87|1.8|||||Hazard Ratio based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by melanoma risk-based stage (IIB/IIC/clinical IIB and IIC/IIIA/IIIB vs IIIC/IIID/IV) and region of enrollment (Asia vs ROW).|||1.80|0.87|
71004675|NCT00142818|141517448|SUPERIORITY|||||||0.4|||||||ANOVA|||||||0.4
71004676|NCT03793010|141517453|SUPERIORITY||Mean Difference (Final Values)|0.31|||||TWO_SIDED|95.0|-1.2|1.81||||||||1.81|-1.20|
71004677|NCT03793010|141517454|SUPERIORITY||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-1.05|2.24||||||||2.24|-1.05|
71004678|NCT03793010|141517455|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-1.0|0.9||||||||0.9|-1.0|
71004679|NCT02219516|141517460|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|153.0|||||TWO_SIDED|90.0|115.0|203.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||203|115|
71004680|NCT02219516|141517460|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|173.0|||||TWO_SIDED|90.0|131.0|230.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||230|131|
71004681|NCT02219516|141517460|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|228.0|||||TWO_SIDED|90.0|155.0|336.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||336|155|
71004682|NCT02219516|141517462|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|131.0|||||TWO_SIDED|90.0|98.6|174.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||174|98.6|
71004683|NCT02219516|141517462|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|222.0|||||TWO_SIDED|90.0|171.0|287.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||287|171|
71004684|NCT02219516|141517462|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|211.0|||||TWO_SIDED|90.0|139.0|319.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||319|139|
71004685|NCT02219516|141517463|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|124.0|||||TWO_SIDED|90.0|88.8|173.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||173|88.8|
71004686|NCT02219516|141517463|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|248.0|||||TWO_SIDED|90.0|168.0|366.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||366|168|
71004687|NCT02219516|141517463|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|230.0|||||TWO_SIDED|90.0|146.0|363.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||363|146|
71004688|NCT02219516|141517465|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|76.0|||||TWO_SIDED|90.0|57.1|101.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||101|57.1|
71004689|NCT02219516|141517465|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|45.1|||||TWO_SIDED|90.0|34.9|58.3|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||58.3|34.9|
71004690|NCT02219516|141517465|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|47.8|||||TWO_SIDED|90.0|31.5|72.5|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||72.5|31.5|
71101484|NCT04003142|141710818|SUPERIORITY||LSMean difference|-20.1|STANDARD_ERROR_OF_MEAN|3.98|<|0.001||95.0|-27.93|-12.27||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-12.27|-27.93|<0.001
71004691|NCT02219516|141517466|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|80.8|||||TWO_SIDED|90.0|57.9|113.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||113|57.9|
71004692|NCT02219516|141517466|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|40.3|||||TWO_SIDED|90.0|27.3|59.5|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||59.5|27.3|
71004693|NCT02219516|141517466|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|43.5|||||TWO_SIDED|90.0|27.5|68.7|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||68.7|27.5|
71004694|NCT02219516|141517467|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|95.4|||||TWO_SIDED|90.0|60.6|150.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||150|60.6|
71101485|NCT04003142|141710818|SUPERIORITY||LSMean difference|-14.96|STANDARD_ERROR_OF_MEAN|4.07|<|0.001||95.0|-22.96|-6.96||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-6.96|-22.96|<0.001
71101486|NCT04003142|141710818|SUPERIORITY||LSMean difference|-20.15|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-28.13|-12.18||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-12.18|-28.13|<0.001
71004695|NCT02219516|141517467|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|58.3|||||TWO_SIDED|90.0|30.2|113.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||113|30.2|
71004696|NCT02219516|141517467|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|21.2|||||TWO_SIDED|90.0|13.6|32.8|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||32.8|13.6|
71004697|NCT01426009|141517536|SUPERIORITY|Day 7 analysis|Least Squares Mean Difference (SE)|0.0723|STANDARD_ERROR_OF_MEAN|0.0188||0.0003|TWO_SIDED|95.0|0.0347|0.1099|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response,with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence. A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.1099|0.0347|0.0003
71004698|NCT01426009|141517536|SUPERIORITY|Day 7 analysis|Least Squares Mean Difference (SE)|0.0676|STANDARD_ERROR_OF_MEAN|0.0184||0.0006|TWO_SIDED|95.0|0.0307|0.1046|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response,with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.1046|0.0307|0.0006
71004699|NCT01426009|141517536|SUPERIORITY|Day 7 analysis|Least Squares Mean Difference (SE)|0.1021|STANDARD_ERROR_OF_MEAN|0.0188|<|0.0001|TWO_SIDED|95.0|0.0644|0.1398|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.1398|0.0644|<0.0001
71004700|NCT01426009|141517536|SUPERIORITY|Day 7 analysis|Least Squares Mean Difference (SE)|0.1299|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.0918|0.1681|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||00.1681|0.0918|<0.0001
71004701|NCT01426009|141517536|SUPERIORITY|Day 7 analysis|Least Squares Mean Difference (SE)|0.0446|STANDARD_ERROR_OF_MEAN|0.0186||0.02|TWO_SIDED|95.0|0.0073|0.082|||Mantel Haenszel||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.0820|0.0073|0.0200
71008645|NCT02055976|141525237|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.7116|STANDARD_ERROR_OF_MEAN|0.852||0.024|TWO_SIDED|95.0|0.0184|3.4049|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||3.4049|0.0184|0.024
71008646|NCT02055976|141525237|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.8585|STANDARD_ERROR_OF_MEAN|0.7844||0.138|TWO_SIDED|95.0|-0.6992|2.4163|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||2.4163|-0.6992|0.138
71008647|NCT02055976|141525237|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.8807|STANDARD_ERROR_OF_MEAN|0.799||0.137|TWO_SIDED|95.0|-0.7064|2.4678|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||2.4678|-0.7064|0.137
71008648|NCT02055976|141525237|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.2624|STANDARD_ERROR_OF_MEAN|0.8053||0.373|TWO_SIDED|95.0|-1.337|1.8618|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.8618|-1.3370|0.373
71008649|NCT02055976|141525237|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.3239|STANDARD_ERROR_OF_MEAN|0.7472||0.333|TWO_SIDED|95.0|-1.1611|1.8089|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.8089|-1.1611|0.333
71008650|NCT02055976|141525237|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.9322|STANDARD_ERROR_OF_MEAN|0.7488||0.006|TWO_SIDED|95.0|0.4441|3.4203|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||3.4203|0.4441|0.006
70925119|NCT02995434|141343520|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|0.62|||||TWO_SIDED|95.0|-0.49|1.89|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||1.89|-0.49|
70925120|NCT02995434|141343520|EQUIVALENCE|See comments in primary outcome|Mean Difference (Net)|-0.13|||||TWO_SIDED|95.0|-1.19|1.09|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||1.09|-1.19|
70925121|NCT02995434|141343520|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|0.33|||||TWO_SIDED|95.0|-0.88|1.57|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||1.57|-0.88|
70925122|NCT02995434|141343521|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|2.48|||||TWO_SIDED|95.0|0.02|4.7|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||4.70|0.02|
70925123|NCT02995434|141343521|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|2.04|||||TWO_SIDED|95.0|-0.42|4.39|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||4.39|-0.42|
70925124|NCT02995434|141343521|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|3.79|||||TWO_SIDED|95.0|1.02|6.08|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||6.08|1.02|
70925125|NCT02995434|141343521|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|3.18|||||TWO_SIDED|95.0|0.68|5.69|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||5.69|0.68|
70925126|NCT02995434|141343522|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|-2.31|||||TWO_SIDED|95.0|-5.63|0.98|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||0.98|-5.63|
71004702|NCT01426009|141517536|SUPERIORITY|Day 7 analysis|Least Squares Mean Difference (SE)|0.0813|STANDARD_ERROR_OF_MEAN|0.0284||0.006|TWO_SIDED|95.0|0.0243|0.1382|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.1382|0.0243|0.0060
71004703|NCT01426009|141517536|SUPERIORITY|Day 1 analysis|Least Squares Mean Difference (SE)|0.0385|STANDARD_ERROR_OF_MEAN|0.0183||0.0402|TWO_SIDED|95.0|0.0018|0.0752|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.0752|0.0018|0.0402
71044115|NCT02310763|141597662|SUPERIORITY||Mean Difference (Net)|-0.236||||0.4975|TWO_SIDED|95.0|-0.924|0.451||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right knee extension, Week 17||0.451|-0.924|0.4975
71044116|NCT02310763|141597662|SUPERIORITY||Mean Difference (Net)|-0.467||||0.2646|TWO_SIDED|95.0|-1.294|0.359||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right knee extension, Week 33||0.359|-1.294|0.2646
70925127|NCT02995434|141343522|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|-3.9|||||TWO_SIDED|95.0|-7.35|-0.48|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||-0.48|-7.35|
70925128|NCT02995434|141343522|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|-0.87|||||TWO_SIDED|95.0|-4.11|2.62|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||2.62|-4.11|
70925129|NCT02995434|141343522|EQUIVALENCE|See comments in primary outcome|Median Difference (Net)|-2.95|||||TWO_SIDED|95.0|-6.1|0.41|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method.|||0.41|-6.10|
70925130|NCT03779204|141343523|OTHER||Mean Difference (Final Values)|-2.0||||0.18|TWO_SIDED|95.0|-5.0|1.0|||ANCOVA|||||1.0|-5.0|0.18
70925131|NCT03779204|141343524|OTHER||Mean Difference (Final Values)|-1.4||||0.44|TWO_SIDED|95.0|-5.0|2.3|||ANCOVA|||||2.3|-5.0|0.44
70925132|NCT03779204|141343525|OTHER||Mean Difference (Final Values)|7.3||||0.38|TWO_SIDED|95.0|-9.7|24.4|||ANCOVA|||||24.4|-9.7|.38
70925133|NCT03779204|141343526|OTHER||Mean Difference (Final Values)|0.6||||0.76|TWO_SIDED|95.0|-3.3|4.4|||ANCOVA|||||4.4|-3.3|0.76
70925134|NCT03779204|141343527|OTHER|||||||0.68|||||||ANCOVA|||||||0.68
70925135|NCT03779204|141343528|OTHER||Mean Difference (Final Values)|-7.2||||0.12|TWO_SIDED|95.0|-16.4|2.0|||ANCOVA|||||2.0|-16.4|0.12
70925136|NCT03779204|141343529|OTHER||Mean Difference (Final Values)|-4.4||||0.34|TWO_SIDED|95.0|-13.7|5.0|||ANCOVA|||||5.0|-13.7|0.34
71044117|NCT02310763|141597662|SUPERIORITY||Mean Difference (Net)|-0.149||||0.732|TWO_SIDED|95.0|-1.008|0.71||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right knee extension, Week 49||0.710|-1.008|0.7320
71044118|NCT02310763|141597663|SUPERIORITY||Mean Difference (Net)|-0.044||||0.8569|TWO_SIDED|95.0|-0.525|0.437||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left shoulder abduction, Week 17||0.437|-0.525|0.8569
70925137|NCT03779204|141343531|OTHER||Mean Difference (Final Values)|-1.3||||0.62|TWO_SIDED|95.0|-6.6|4.0|||ANCOVA|||||4.0|-6.6|0.62
70925138|NCT04318548|141343571|NON_INFERIORITY|NI was to be demonstrated if the lower limit (LL) of the 2-sided 95% CI of the GMT ratio between the MenB+MenACWY group and MenB group for hSBA titers against M14459 (fHbp) strain was above (\>) 0.5|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.77|1.06|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority (NI) of the antibody response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis serogroup B indicator strains at one month after the second vaccination with rMenB+OMV NZ (at Day 91).||1.06|0.77|
71004704|NCT01426009|141517536|SUPERIORITY|Day 1 analysis|Least Squares Mean Difference (SE)|0.0696|STANDARD_ERROR_OF_MEAN|0.0179||0.0003|TWO_SIDED|95.0|0.0337|0.1055|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.1055|0.0337|0.0003
71004705|NCT01426009|141517536|SUPERIORITY|Day 1 analysis|Least Squares Mean|0.0501|STANDARD_ERROR_OF_MEAN|0.018||0.0074|TWO_SIDED|95.0|0.014|0.0861|||ANCOVA|||An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.0861|0.0140|0.0074
71004706|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.0767|STANDARD_ERROR_OF_MEAN|0.0131|<|0.0001|TWO_SIDED|95.0|0.0505|0.1028|||ANCOVA||standard error of the mean difference|ACU 0-24 on Day 1||0.1028|0.0505|<0.0001
71044119|NCT02310763|141597663|SUPERIORITY||Mean Difference (Net)|-0.154||||0.5495|TWO_SIDED|95.0|-0.663|0.355||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left shoulder abduction, Week 33||0.355|-0.663|0.5495
71004707|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.122|STANDARD_ERROR_OF_MEAN|0.0127|<|0.0001|TWO_SIDED|95.0|0.0965|0.1475|||ANCOVA||standard error of the Mean difference|ACU 0-24 Day 1||0.1475|0.0965|<0.0001
71044120|NCT02310763|141597663|SUPERIORITY||Mean Difference (Net)|-0.023||||0.934|TWO_SIDED|95.0|-0.566|0.521||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left shoulder abduction, Week 49||0.521|-0.566|0.9340
71044121|NCT02310763|141597663|SUPERIORITY||Mean Difference (Net)|-0.236||||0.3279|TWO_SIDED|95.0|-0.711|0.239||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right shoulder abduction, Week 17||0.239|-0.711|0.3279
71044122|NCT02310763|141597663|SUPERIORITY||Mean Difference (Net)|-0.757||||0.0086|TWO_SIDED|95.0|-1.318|-0.196||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right shoulder abduction, Week 33||-0.196|-1.318|0.0086
71044123|NCT02310763|141597663|SUPERIORITY||Mean Difference (Net)|-0.439||||0.2328|TWO_SIDED|95.0|-1.165|0.286||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right shoulder abduction, Week 49||0.286|-1.165|0.2328
71044124|NCT02310763|141597664|EQUIVALENCE|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|0.211||||0.8908|TWO_SIDED|95.0|-2.8353|3.2573|||Mixed Models Analysis||Mean difference was calculated by Sequence 3 minus natural history control group.|||3.2573|-2.8353|0.8908
71004708|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.1222|STANDARD_ERROR_OF_MEAN|0.0128|<|0.0001|TWO_SIDED|95.0|0.0965|0.1479|||ANCOVA||standard error of the Mean difference|AUC 0-24 Day 1||0.1479|0.0965|<0.0001
71101487|NCT04003142|141710818|SUPERIORITY||LSMean difference|-13.64|STANDARD_ERROR_OF_MEAN|4.07|<|0.001||95.0|-21.62|-5.65||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 12||-5.65|-21.62|<0.001
71004709|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.1625|STANDARD_ERROR_OF_MEAN|0.0131|<|0.0001|TWO_SIDED|95.0|0.1362|0.1888|||ANCOVA||standard error of the Mean difference|AUC 0-24 day 1||0.1888|0.1362|<0.0001
70925139|NCT04318548|141343571|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the GMT ratio between the MenB+MenACWY group and MenB group for hSBA titers against 96217 (NadA) strain was \>0.5|GMT Ratio|0.88|||||TWO_SIDED|95.0|0.75|1.04|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis serogroup B indicator strains at one month after the second vaccination with rMenB+OMV NZ (at Day 91).||1.04|0.75|
70925140|NCT04318548|141343571|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the GMT ratio between the MenB+MenACWY group and MenB group for hSBA titers against NZ98/254 (PorA) strain was \>0.5.|GMT Ratio|0.93|||||TWO_SIDED|95.0|0.76|1.12|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis serogroup B indicator strains at one month after the second vaccination with rMenB+OMV NZ (at Day 91).||1.12|0.76|
71004710|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.169|STANDARD_ERROR_OF_MEAN|0.0128|<|0.0001|TWO_SIDED|95.0|0.1434|0.1946|||ANCOVA||standard error of the Mean difference|AUC 0-24 day 1||0.1946|0.1434|<0.0001
71044125|NCT02310763|141597665|SUPERIORITY|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|0.819||||0.4748|TWO_SIDED|95.0|-1.4514|3.0895|||Mixed Models Analysis||Mean difference was calculated by Sequence 1 minus natural history control group.|||3.0895|-1.4514|0.4748
71044126|NCT02310763|141597666|EQUIVALENCE|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|0.0097||||0.807|TWO_SIDED|95.0|-0.0692|0.0887|||Mixed Models Analysis||Mean difference was calculated by Sequence 3 minus natural history control group.|||0.0887|-0.0692|0.8070
71044127|NCT02310763|141597667|SUPERIORITY|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|0.0506||||0.3643|TWO_SIDED|95.0|-0.0594|0.1607|||Mixed Models Analysis||Mean difference was calculated by Sequence 1 minus natural history control group.|||0.1607|-0.0594|0.3643
71044128|NCT02310763|141597668|EQUIVALENCE|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|-2.9||||0.0483|TWO_SIDED|95.0|-5.7|0.0|||Mixed Models Analysis||Mean difference was calculated by Sequence 3 minus natural history control group.|||0|-5.7|0.0483
71101488|NCT04003142|141710818|SUPERIORITY||LSMean difference|-18.94|STANDARD_ERROR_OF_MEAN|4.05|<|0.001||95.0|-26.89|-10.98||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 12||-10.98|-26.89|<0.001
71004711|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.1095|STANDARD_ERROR_OF_MEAN|0.0189|<|0.0001|TWO_SIDED|95.0|0.0716|0.1473|||ANCOVA||standard error of the Mean difference|AUC 0-24 day 1||0.1473|0.0716|<0.0001
71004712|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.1095|STANDARD_ERROR_OF_MEAN|0.0141|<|0.0001|TWO_SIDED|95.0|0.0812|0.1379|||ANCOVA||standard error of the Mean difference|AUC 0-24 on Day 7||0.1379|0.0812|<0.0001
71004713|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.1271|STANDARD_ERROR_OF_MEAN|0.0139|<|0.0001|TWO_SIDED|95.0|0.0993|0.1548|||ANCOVA||standard error of the Mean difference|AUC0-24 on Day 7||0.1548|0.0993|<0.0001
71004714|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.145|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.1169|0.173|||ANCOVA||standard error of the Mean difference|AUC 0-24 on day 7||0.1730|0.1169|<0.0001
71004715|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.1688|STANDARD_ERROR_OF_MEAN|0.0142|<|0.0001|TWO_SIDED|95.0|0.1403|0.1972|||ANCOVA||standard error of the Mean difference|AUC 0-24 on day 7||0.1972|0.1403|<0.0001
71004716|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.1396|STANDARD_ERROR_OF_MEAN|0.0139|<|0.0001|TWO_SIDED|95.0|0.1117|0.173|||ANCOVA||standard error of the Mean difference|AUC 0-24 on day 7||0.1730|0.1117|<0.0001
71004717|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.1183|STANDARD_ERROR_OF_MEAN|0.0194|<|0.0001|TWO_SIDED|95.0|0.0795|0.1972|||ANCOVA||standard error of the Mean difference|AUC 0-24 on day 7||0.1972|0.0795|<0.0001
71004718|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.1038|STANDARD_ERROR_OF_MEAN|0.0131|<|0.0001|TWO_SIDED|95.0|0.0776|0.1301|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1||0.1301|0.0776|<0.0001
71004719|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.1468|STANDARD_ERROR_OF_MEAN|0.0128|<|0.0001|TWO_SIDED|95.0|0.1212|0.1724|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1||0.1724|0.1212|<0.0001
71004720|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.1579|STANDARD_ERROR_OF_MEAN|0.0128|<|0.0001|TWO_SIDED|95.0|0.1322|0.1837|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1||0.1837|0.1322|<0.0001
71004721|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.1919|STANDARD_ERROR_OF_MEAN|0.0132|<|0.0001|TWO_SIDED|95.0|0.1655|0.2184|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1||0.2184|0.1655|<0.0001
71004722|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.1994|STANDARD_ERROR_OF_MEAN|0.0128|<|0.0001|TWO_SIDED|95.0|0.1738|0.2251|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1||0.2251|0.1738|<0.0001
71004723|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.1248|STANDARD_ERROR_OF_MEAN|0.0188|<|0.0001|TWO_SIDED|95.0|0.0872|0.1625|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1||0.1625|0.0872|<0.0001
71004724|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.1279|STANDARD_ERROR_OF_MEAN|0.0154|<|0.0001|TWO_SIDED|95.0|0.097|0.1587|||ANCOVA|standard error of the Mean difference|standard error of the Mean difference|AUC 0-12 on day 7||0.1587|0.0970|<0.0001
71004725|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.1454|STANDARD_ERROR_OF_MEAN|0.0151|<|0.0001|TWO_SIDED|95.0|0.1151|0.1756|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 7||0.1756|0.1151|<0.0001
71004726|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.1699|STANDARD_ERROR_OF_MEAN|0.0152|<|0.0001|TWO_SIDED|95.0|0.1393|0.2004|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 7||0.2004|0.1393|<0.0001
70925141|NCT04318548|141343571|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the GMT ratio between the MenB+MenACWY group and MenB group for hSBA titers against M13520 (NHBA) strain was \>0.5|GMT Ratio|0.88|||||TWO_SIDED|95.0|0.73|1.06|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis serogroup B indicator strains at one month after the second vaccination with rMenB+OMV NZ (at Day 91).||1.06|0.73|
70925142|NCT04318548|141343572|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the between-group ratio of hSBA GMTs between MenB+MenACWY group and MenACWY group for Men A serogroup was \>0.5.|GMT Ratio|0.94|||||TWO_SIDED|95.0|0.78|1.14|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenACWY) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to MenACWY given concomitantly with rMenB+OMV NZ compared to MenACWY administered alone, as measured by hSBA GMTs against the N. meningitidis serogroup Men A, at one month after the vaccination with MenACWY (at Day 31).||1.14|0.78|
70925143|NCT04318548|141343572|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the between-group ratio of hSBA GMTs between MenB+MenACWY group and MenACWY group for Men C serogroup was \>0.5.|GMT Ratio|1.11|||||TWO_SIDED|95.0|0.86|1.44|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenACWY) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to MenACWY given concomitantly with rMenB+OMV NZ compared to MenACWY administered alone, as measured by hSBA GMTs against the N. meningitidis serogroup Men C, at one month after the vaccination with MenACWY (at Day 31).||1.44|0.86|
70925144|NCT04318548|141343572|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the between-group ratio of hSBA GMTs between MenB+MenACWY group and MenACWY group for Men W serogroup was \>0.5.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.82|1.21|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenACWY) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to MenACWY given concomitantly with rMenB+OMV NZ compared to MenACWY administered alone, as measured by hSBA GMTs against the N. meningitidis serogroup Men W, at one month after the vaccination with MenACWY (at Day 31).||1.21|0.82|
70925145|NCT04318548|141343572|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the between-group ratio of hSBA GMTs between MenB+MenACWY group and MenACWY group for Men Y serogroup was \>0.5.|GMT Ratio|1.03|||||TWO_SIDED|95.0|0.84|1.27|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenACWY) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to MenACWY given concomitantly with rMenB+OMV NZ compared to MenACWY administered alone, as measured by hSBA GMTs against the N. meningitidis serogroup Men Y, at one month after the vaccination with MenACWY (at Day 31).||1.27|0.84|
71004727|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.1814|STANDARD_ERROR_OF_MEAN|0.0155|<|0.0001|TWO_SIDED|95.0|0.1503|0.2125|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 7||0.2125|0.1503|<0.0001
71004728|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.1697|STANDARD_ERROR_OF_MEAN|0.0152|<|0.0001|TWO_SIDED|95.0|0.1393|0.201|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 7||0.201|0.1393|<0.0001
71004729|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.1384|STANDARD_ERROR_OF_MEAN|0.0216|<|0.0001|TWO_SIDED|95.0|0.0951|0.1817|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 7||0.1817|0.0951|<0.0001
71044129|NCT02310763|141597669|SUPERIORITY|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|-3.9||||0.0146|TWO_SIDED|95.0|-7.0|-0.8|||Mixed Models Analysis||Mean difference was calculated by Sequence 1 minus natural history control group.|||-0.8|-7.0|0.0146
71004730|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.0471|STANDARD_ERROR_OF_MEAN|0.0157|<|0.0001|TWO_SIDED|95.0|0.0155|0.0786|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 1||0.0786|0.0155|<0.0001
71004731|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.0918|STANDARD_ERROR_OF_MEAN|0.0154|<|0.0001|TWO_SIDED|95.0|0.0611|0.1226|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 1||0.1226|0.0611|<0.0001
71004732|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.0829|STANDARD_ERROR_OF_MEAN|0.0155|<|0.0001|TWO_SIDED|95.0|0.0519|0.1139|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 1||0.1139|0.0519|<0.0001
71044130|NCT02310763|141597670|EQUIVALENCE|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|-31.6||||0.1669|TWO_SIDED|95.0|-76.9|13.6|||Mixed Models Analysis||Mean difference was calculated by Sequence 3 minus natural history control group.|||13.6|-76.9|0.1669
71004733|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.1299|STANDARD_ERROR_OF_MEAN|0.0158|<|0.0001|TWO_SIDED|95.0|0.0982|0.1617|||ANCOVA||standard error of the Mean difference|AUC 12-24 o day 1||0.1617|0.0982|<0.0001
71004734|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.1369|STANDARD_ERROR_OF_MEAN|0.0154|<|0.0001|TWO_SIDED|95.0|0.1061|0.1678|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 1||0.1678|0.1061|<0.0001
71004735|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.0934|STANDARD_ERROR_OF_MEAN|0.0221|<|0.0001|TWO_SIDED|95.0|0.049|0.1377|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 1||0.1377|0.0490|<0.0001
71004736|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.0879|STANDARD_ERROR_OF_MEAN|0.0153|<|0.0001|TWO_SIDED|95.0|0.0573|0.1186|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 7||0.1186|0.0573|<0.0001
71004737|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.1088|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.0788|0.1388|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 7||0.1388|0.0788|<0.0001
71004738|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.1175|STANDARD_ERROR_OF_MEAN|0.0151|<|0.0001|TWO_SIDED|95.0|0.0872|0.1478|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 7||0.1478|0.0872|<0.0001
71044131|NCT02310763|141597671|SUPERIORITY|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|-66.3||||0.0267|TWO_SIDED|95.0|-124.5|-8.1|||Mixed Models Analysis||Mean difference was calculated by Sequence 1 minus natural history control group.|||-8.1|-124.5|0.0267
71044132|NCT02310763|141597672|SUPERIORITY||Mean Difference (Net)|-0.0692||||0.7033|TWO_SIDED|95.0|-0.4345|0.2961||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||0.2961|-0.4345|0.7033
71044133|NCT02310763|141597672|SUPERIORITY||Mean Difference (Net)|0.2114||||0.6893|TWO_SIDED|95.0|-0.8472|1.27||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<= 8 seconds||1.27|-0.8472|0.6893
71044134|NCT02310763|141597672|SUPERIORITY||Mean Difference (Net)|-2.6439||||0.6469|TWO_SIDED|95.0|-14.4292|9.1414||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||9.1414|-14.4292|0.6469
71044135|NCT02310763|141597673|SUPERIORITY||Mean Difference (Net)|-0.3289||||0.1353|TWO_SIDED|95.0|-0.7649|0.1072||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||0.1072|-0.7649|0.1353
71044136|NCT02310763|141597673|SUPERIORITY||Mean Difference (Net)|0.3457||||0.7648|TWO_SIDED|95.0|-1.9614|2.6528||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||2.6528|-1.9614|0.7648
71044137|NCT02310763|141597673|SUPERIORITY||Mean Difference (Net)|8.2893||||0.3562|TWO_SIDED|95.0|-9.6409|26.2194||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||26.2194|-9.6409|0.3562
71044138|NCT02310763|141597674|SUPERIORITY||Mean Difference (Net)|-0.5582||||0.1163||95.0|-1.2615|0.1451||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||0.1451|-1.2615|0.1163
71044139|NCT02310763|141597674|SUPERIORITY||Mean Difference (Net)|0.0944||||0.9503|TWO_SIDED|95.0|-3.0798|3.2686||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||3.2686|-3.0798|0.9503
71101489|NCT04003142|141710819|SUPERIORITY||Odds Ratio (OR)|1.881||||0.02||95.0|1.11|3.233||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 1||3.233|1.110|0.020
71044140|NCT02310763|141597674|SUPERIORITY||Mean Difference (Net)|-11.2881||||0.2947|TWO_SIDED|95.0|-32.8328|10.2566||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||10.2566|-32.8328|0.2947
71044141|NCT02310763|141597675|SUPERIORITY||Mean Difference (Net)|0.0159||||0.8229|TWO_SIDED|95.0|-0.127|0.1588||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||0.1588|-0.1270|0.8229
71044142|NCT02310763|141597675|SUPERIORITY||Mean Difference (Net)|-0.0132||||0.7709|TWO_SIDED|95.0|-0.1036|0.0772||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||0.0772|-0.1036|0.7709
71044143|NCT02310763|141597675|SUPERIORITY||Mean Difference (Net)|0.0889||||0.3746|TWO_SIDED|95.0|-0.1219|0.2996||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||0.2996|-0.1219|0.3746
71101490|NCT04003142|141710819|SUPERIORITY||Odds Ratio (OR)|2.645|||<|0.001|TWO_SIDED|95.0|1.585|4.498||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 1||4.498|1.585|<0.001
71101491|NCT04003142|141710819|SUPERIORITY||Odds Ratio (OR)|2.464|||<|0.001||95.0|1.535|4.001||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||4.001|1.535|<0.001
71101492|NCT04003142|141710819|SUPERIORITY||Odds Ratio (OR)|2.464|||<|0.001|TWO_SIDED|95.0|1.534|4.004||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||4.004|1.534|<0.001
71004739|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.1532|STANDARD_ERROR_OF_MEAN|0.0153|<|0.0001|TWO_SIDED|95.0|0.1226|0.1838|||ANCOVA||standard error of the Mean difference|||0.1838|0.1226|<0.0001
71004740|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.1048|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.0747|0.135|||ANCOVA||standard error of the Mean difference|||0.1350|0.0747|<0.0001
71044144|NCT02310763|141597676|SUPERIORITY||Mean Difference (Net)|-0.0934||||0.2294|TWO_SIDED|95.0|-0.2481|0.0613||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||0.0613|-0.2481|0.2294
71044145|NCT02310763|141597676|SUPERIORITY||Mean Difference (Net)|-0.0117||||0.8485|TWO_SIDED|95.0|-0.1339|0.1105||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<= 8 seconds||0.1105|-0.1339|0.8485
71044146|NCT02310763|141597676|SUPERIORITY||Mean Difference (Net)|0.0562||||0.6645|TWO_SIDED|95.0|-0.2187|0.3312||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||0.3312|-0.2187|0.6645
71101493|NCT04003142|141710819|SUPERIORITY||Odds Ratio (OR)|2.367|||<|0.001||95.0|1.502|3.762||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||3.762|1.502|<0.001
71004741|NCT01426009|141517537|SUPERIORITY||Least Squares Mean Difference (SE)|0.0993|STANDARD_ERROR_OF_MEAN|0.0202|<|0.0001|TWO_SIDED|95.0|0.0589|0.1398|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 7||0.1398|0.0589|<0.0001
71004742|NCT01526928|141517605|OTHER||||||||||||||||||Since an MTD was never reached for any of the rociletinib FB or HBr formulations/doses, a 750 mg BID HBr starting dose was selected based on early efficacy data from Phase 1, and enrollment into Phase 2 was initiated at this dosage. As the Phase 1 efficacy data matured, the recommended dose was adjusted to 625 mg BID based on antitumor activity and safety evaluations.|||
71004743|NCT01108068|141517620|EQUIVALENCE|Continuous variables were expressed as means ± SD or median (range). Group differences in pQCT Z-scores according to genotype T-test was used to compare differences at baseline between affecteds and unaffecteds||||||0.0003|||||||t-test, 1 sided|Differences in the two groups were assessed using Student's t-test or the rank-sum test if skewed.||Cortical area Z-score||||0.0003
71044147|NCT02310763|141597677|SUPERIORITY||Mean Difference (Net)|-0.1013||||0.2101|TWO_SIDED|95.0|-0.2622|0.0597||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||0.0597|-0.2622|0.2101
71044148|NCT02310763|141597677|SUPERIORITY||Mean Difference (Net)|-0.0359||||0.4603|TWO_SIDED|95.0|-0.1326|0.0608||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<= 8 seconds||0.0608|-0.1326|0.4603
71044149|NCT02310763|141597677|SUPERIORITY||Mean Difference (Net)|0.1039||||0.3739|TWO_SIDED|95.0|-0.1386|0.3463||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||0.3463|-0.1386|0.3739
71044150|NCT02310763|141597678|SUPERIORITY||Mean Difference (Net)|-0.3||||0.8925|TWO_SIDED|95.0|-4.5|3.9||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||3.9|-4.5|0.8925
71044151|NCT02310763|141597678|SUPERIORITY||Mean Difference (Net)|1.2||||0.2107|TWO_SIDED|95.0|-0.7|3.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||3.2|-0.7|0.2107
71044152|NCT02310763|141597678|SUPERIORITY||Mean Difference (Net)|1.3||||0.2298|TWO_SIDED|95.0|-0.9|3.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||3.5|-0.9|0.2298
71044153|NCT02310763|141597679|SUPERIORITY||Mean Difference (Net)|3.5||||0.0554|TWO_SIDED|95.0|-0.1|7.1||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||7.1|-0.1|0.0554
71044154|NCT02310763|141597679|SUPERIORITY||Mean Difference (Net)|1.6||||0.2027|TWO_SIDED|95.0|-0.9|4.0||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<= 8 seconds||4.0|-0.9|0.2027
71044155|NCT02310763|141597679|SUPERIORITY||Mean Difference (Net)|2.9||||0.0926|TWO_SIDED|95.0|-0.5|6.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||6.3|-0.5|0.0926
71004744|NCT01108068|141517620|EQUIVALENCE|Continuous variables were expressed as means ± SD or median (range). Group differences in pQCT Z-scores according to genotype||||||0.001|||||||t-test, 1 sided|Differences in the two groups were assessed using Student's t-test or the rank-sum test if skewed.||Periosteal circumference Z-score||||0.001
71044156|NCT02310763|141597680|SUPERIORITY||Mean Difference (Net)|2.0||||0.3597|TWO_SIDED|95.0|-2.4|6.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||6.3|-2.4|0.3597
71044157|NCT02310763|141597680|SUPERIORITY||Mean Difference (Net)|0.5||||0.7345|TWO_SIDED|95.0|-2.3|3.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||3.3|-2.3|0.7345
71044158|NCT02310763|141597680|SUPERIORITY||Mean Difference (Net)|4.0||||0.032|TWO_SIDED|95.0|0.4|7.7||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||7.7|0.4|0.0320
71044159|NCT02310763|141597681|SUPERIORITY||Mean Difference (Net)|1.2||||0.3345|TWO_SIDED|95.0|-1.3|3.8||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||3.8|-1.3|0.3345
71004745|NCT04716010|141517665|SUPERIORITY|||||||0.002||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||0.002
71004746|NCT04716010|141517665|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
71044160|NCT02310763|141597681|SUPERIORITY||Mean Difference (Net)|-1.2||||0.14|TWO_SIDED|95.0|-2.9|0.4||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<= 8 seconds||0.4|-2.9|0.1400
71044161|NCT02310763|141597681|SUPERIORITY||Mean Difference (Net)|-0.9||||0.6764|TWO_SIDED|95.0|-5.4|3.6||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||3.6|-5.4|0.6764
71044162|NCT02310763|141597682|SUPERIORITY||Mean Difference (Net)|6.5||||0.097|TWO_SIDED|95.0|-1.2|14.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||14.2|-1.2|0.0970
71044163|NCT02310763|141597682|SUPERIORITY||Mean Difference (Net)|-0.3||||0.6919|TWO_SIDED|95.0|-1.9|1.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||1.3|-1.9|0.6919
71044164|NCT02310763|141597682|SUPERIORITY||Mean Difference (Net)|-1.0||||0.6736|TWO_SIDED|95.0|-5.8|3.9||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||3.9|-5.8|0.6736
71004747|NCT04716010|141517665|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
71004748|NCT04716010|141517665|SUPERIORITY|||||||0.024||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||0.024
71004749|NCT04716010|141517665|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
71004750|NCT04716010|141517665|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
71004751|NCT04716010|141517666|SUPERIORITY|||||||0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||0.001
71004752|NCT04716010|141517666|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
71044165|NCT02310763|141597683|SUPERIORITY||Mean Difference (Net)|0.0||||0.9582|TWO_SIDED|95.0|-1.5|1.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||1.5|-1.5|0.9582
71044166|NCT02310763|141597683|SUPERIORITY||Mean Difference (Net)|-0.1||||0.8629|TWO_SIDED|95.0|-1.8|1.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<= 8 seconds||1.5|-1.8|0.8629
71004753|NCT04716010|141517666|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
71004754|NCT04716010|141517666|SUPERIORITY|||||||0.022||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||0.022
71004755|NCT04716010|141517666|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
71044167|NCT02310763|141597683|SUPERIORITY||Mean Difference (Net)|-0.9||||0.6746|TWO_SIDED|95.0|-5.5|3.7||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||3.7|-5.5|0.6746
71044168|NCT02310763|141597684|SUPERIORITY||Mean Difference (Net)|-5.8||||0.7483|TWO_SIDED|95.0|-42.4|30.7||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||30.7|-42.4|0.7483
71004756|NCT04716010|141517666|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
71004757|NCT04716010|141517667|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \>0.05|Regression, Linear|||||||>0.05
71004758|NCT04716010|141517667|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004759|NCT04716010|141517667|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004760|NCT04716010|141517667|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004761|NCT04716010|141517667|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004762|NCT04716010|141517667|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004763|NCT04716010|141517668|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004764|NCT04716010|141517668|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004765|NCT04716010|141517668|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004766|NCT04716010|141517668|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004767|NCT04716010|141517668|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004768|NCT04716010|141517668|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004769|NCT04716010|141517669|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004770|NCT04716010|141517669|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004771|NCT04716010|141517669|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004772|NCT04716010|141517669|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004773|NCT04716010|141517669|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004774|NCT04716010|141517669|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004775|NCT04716010|141517670|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71044169|NCT02310763|141597684|SUPERIORITY||Mean Difference (Net)|-1.3||||0.9053|TWO_SIDED|95.0|-23.9|21.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||21.2|-23.9|0.9053
71004776|NCT04716010|141517670|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004777|NCT04716010|141517670|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004778|NCT04716010|141517670|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71044170|NCT02310763|141597684|SUPERIORITY||Mean Difference (Net)|13.1||||0.6896|TWO_SIDED|95.0|-53.4|79.7||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||79.7|-53.4|0.6896
71004779|NCT04716010|141517670|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71044171|NCT02310763|141597685|SUPERIORITY||Mean Difference (Net)|-3.7||||0.8117|TWO_SIDED|95.0|-34.8|27.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||27.5|-34.8|0.8117
71044172|NCT02310763|141597685|SUPERIORITY||Mean Difference (Net)|7.3||||0.6018|TWO_SIDED|95.0|-20.6|35.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||35.2|-20.6|0.6018
71044173|NCT02310763|141597685|SUPERIORITY||Mean Difference (Net)|16.3||||0.7152|TWO_SIDED|95.0|-73.4|106.0||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||106.0|-73.4|0.7152
71044174|NCT02310763|141597686|SUPERIORITY||Mean Difference (Net)|7.0||||0.719|TWO_SIDED|95.0|-32.1|46.1||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||46.1|-32.1|0.7190
71004780|NCT04716010|141517670|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
71004781|NCT04716010|141517671|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004782|NCT04716010|141517671|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004783|NCT04716010|141517671|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004784|NCT04716010|141517671|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004785|NCT04716010|141517671|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71044175|NCT02310763|141597686|SUPERIORITY||Mean Difference (Net)|-15.8||||0.4634|TWO_SIDED|95.0|-58.9|27.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||27.3|-58.9|0.4634
71004786|NCT04716010|141517671|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004787|NCT04716010|141517672|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004788|NCT04716010|141517672|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004789|NCT04716010|141517672|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004790|NCT04716010|141517672|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004791|NCT04716010|141517672|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004792|NCT04716010|141517672|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71044176|NCT02310763|141597686|SUPERIORITY||Mean Difference (Net)|3.9||||0.94|TWO_SIDED|95.0|-100.7|108.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||108.5|-100.7|0.9400
71044177|NCT02310763|141597690|SUPERIORITY||Mean Difference (Net)|2.945||||0.0087|TWO_SIDED|95.0|0.7597|5.1309||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||5.1309|0.7597|0.0087
71101494|NCT04003142|141710819|SUPERIORITY||Odds Ratio (OR)|2.894|||<|0.001||95.0|1.835|4.609||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||4.609|1.835|<0.001
71004793|NCT04716010|141517673|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004794|NCT04716010|141517673|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004795|NCT04716010|141517673|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004796|NCT04716010|141517673|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71044178|NCT02310763|141597690|SUPERIORITY||Mean Difference (Net)|2.918||||0.0536|TWO_SIDED|95.0|-0.0461|5.8811||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||5.8811|-0.0461|0.0536
71044179|NCT02310763|141597690|SUPERIORITY||Mean Difference (Net)|4.087||||0.0298|TWO_SIDED|95.0|0.4069|7.7677||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49||7.7677|0.4069|0.0298
71101495|NCT04003142|141710819|SUPERIORITY||Odds Ratio (OR)|2.902|||<|0.001|TWO_SIDED|95.0|1.829|4.657||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||4.657|1.829|<0.001
71004797|NCT04716010|141517673|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004798|NCT04716010|141517673|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004799|NCT04716010|141517674|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004800|NCT04716010|141517674|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004801|NCT04716010|141517674|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004802|NCT04716010|141517674|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004803|NCT04716010|141517674|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004804|NCT04716010|141517674|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004805|NCT04716010|141517675|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004806|NCT04716010|141517675|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004807|NCT04716010|141517675|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004808|NCT04716010|141517675|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004809|NCT04716010|141517675|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004810|NCT04716010|141517675|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004811|NCT04716010|141517676|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004812|NCT04716010|141517676|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004813|NCT04716010|141517676|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004814|NCT04716010|141517676|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004815|NCT04716010|141517676|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004816|NCT04716010|141517676|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004817|NCT04716010|141517677|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004818|NCT04716010|141517677|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71044180|NCT02310763|141597691|SUPERIORITY||Mean Difference (Net)|1.575||||0.0684|TWO_SIDED|95.0|-0.1213|3.2715||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||3.2715|-0.1213|0.0684
71004819|NCT04716010|141517677|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004820|NCT04716010|141517677|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004821|NCT04716010|141517677|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004822|NCT04716010|141517677|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004823|NCT04716010|141517678|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004824|NCT04716010|141517678|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004825|NCT04716010|141517678|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004826|NCT04716010|141517678|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004827|NCT04716010|141517678|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004828|NCT04716010|141517678|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004829|NCT04716010|141517679|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004830|NCT04716010|141517679|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004831|NCT04716010|141517679|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71044181|NCT02310763|141597691|SUPERIORITY||Mean Difference (Net)|2.612||||0.0376|TWO_SIDED|95.0|0.1521|5.0711||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||5.0711|0.1521|0.0376
71044182|NCT02310763|141597691|SUPERIORITY||Mean Difference (Net)|3.208||||0.0411|TWO_SIDED|95.0|0.1318|6.2844||The significance level is 0.05|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49||6.2844|0.1318|0.0411
71004832|NCT04716010|141517679|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004833|NCT04716010|141517679|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004834|NCT04716010|141517679|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004835|NCT04716010|141517680|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004836|NCT04716010|141517680|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004837|NCT04716010|141517680|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004838|NCT04716010|141517680|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004839|NCT04716010|141517680|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004840|NCT04716010|141517680|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004841|NCT04716010|141517681|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004842|NCT04716010|141517681|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004843|NCT04716010|141517681|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004844|NCT04716010|141517681|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004845|NCT04716010|141517681|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004846|NCT04716010|141517681|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004847|NCT04716010|141517682|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004848|NCT04716010|141517682|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004849|NCT04716010|141517682|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004850|NCT04716010|141517682|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004851|NCT04716010|141517682|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004852|NCT04716010|141517682|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004853|NCT04716010|141517683|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004854|NCT04716010|141517683|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004855|NCT04716010|141517683|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004856|NCT04716010|141517683|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004857|NCT04716010|141517683|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004858|NCT04716010|141517683|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004859|NCT04716010|141517684|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004860|NCT04716010|141517684|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71044183|NCT04019054|141597707|SUPERIORITY|Repeated-measure MANOVA was utilized to compare control and active group.||||||0.518|||||||ANOVA|||||||0.518
71044184|NCT04019054|141597708|SUPERIORITY|Repeated-measure MANOVA was utilized to compare control and active group. This allowed for examination between and within each group. Analysis described here is within-group differences.||||||0.008||||||a priori threshold for significance of p=0.05. Observed power η2=0.39.|ANOVA|||||||0.008
71044185|NCT04019054|141597708|SUPERIORITY|Repeated-measure MANOVA was utilized to compare control and active group. This allowed for examination between and within each group. Analysis described here is between-group differences.|||||>|0.05||||||a priori threshold for significance of p=0.05.|ANOVA|||||||>0.05
71044186|NCT04019054|141597709|SUPERIORITY|Repeated-measure MANOVA was utilized to compare control and active group. This allowed for examination between and within each group. Result described here is within-group difference over time.||||||0.004||||||a priori threshold for significance p=0.05. Result above describes within group testing over time. Observed power η2=0.43.|ANOVA|||||||0.004
71044187|NCT04019054|141597709|SUPERIORITY|Repeated-measure MANOVA was utilized to compare control and active group. This allowed for examination between and within each group. Result described here is the between-group comparison|||||>|0.05||||||a priori threshold for significance p=0.05|ANOVA|||||||>0.05
71044188|NCT04019054|141597710|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.01||||||Threshold for significance was p=0.05.|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of skin conductance level (SCL) as a function of step and timepoint. This multi-level model was generated using the menbreg function in Stata 16||||<0.01
71044189|NCT04019054|141597710|SUPERIORITY|||||||0.029||||||a priori threshold for significance of 0.05|Mixed Models Analysis|||The second statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of skin conductance level (SCL) (as a function of step and timepoint).||||0.029
71044190|NCT04019054|141597711|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.001||||||a priori threshold for significance was p=0.05.|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of anticipatory distress as a function of step and timepoint. This multi-level model was generated using the menbreg function in Stata 16||||<0.001
71044191|NCT04019054|141597711|SUPERIORITY|||||||0.63||||||a priori threshold for significance of 0.05|Mixed Models Analysis|||This statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of anticipatory distress as a function of step and timepoint.||||0.63
71044192|NCT04019054|141597711|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.001||||||a priori threshold for significance of p=0.05|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of anticipatory distress as a function of treatment group and timepoint. This multi-level model was generated using the menbreg function in Stata 16||||<.001
71044193|NCT04019054|141597711|SUPERIORITY||||||<|0.001||||||a priori threshold for significance of 0.05|Mixed Models Analysis|||This statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of anticipatory distress as a function of group and timepoint.||||<0.001
71044194|NCT04019054|141597711|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.001||||||a priori threshold for significance was p=0.05.|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of anticipatory distress as a function of step and group. This multi-level model was generated using the menbreg function in Stata 16||||<0.001
71044195|NCT04019054|141597711|SUPERIORITY|||||||0.047||||||a priori threshold for significance of 0.05|Mixed Models Analysis|||This statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of anticipatory distress as a function of step and group.||||0.047
71044196|NCT04019054|141597712|SUPERIORITY||Mann Whitney U statistic|13.5|STANDARD_ERROR_OF_MEAN|9.58||0.027|TWO_SIDED|||||a priori threshold for significance of p=0.05|Wilcoxon (Mann-Whitney)|||2-sided Mann-Whitney U Test (nonparametric) utilized to compare the ability of the groups to tolerate treatment intensity.||||0.027
71044197|NCT04019054|141597714|OTHER|A pair of chi-square analyses were performed to validate blinding of the study (based on questionnaires completed by subjects and raters). Given the small sample size, Fisher's exact method was utilized. The number of correct and incorrect guesses for each group were examined once for the subject guesses and once for the rater's guesses.|||||>|0.05|||||||Fisher Exact|For the subjects, p=0.64 using Fisher's exact method. For the raters, p=1 using Fisher's exact method.||||||>.05
71101496|NCT04003142|141710819|SUPERIORITY||Odds Ratio (OR)|3.218|||<|0.001||95.0|2.025|5.172||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||5.172|2.025|<0.001
71101497|NCT04003142|141710819|SUPERIORITY||Odds Ratio (OR)|2.153|||<|0.001||95.0|1.375|3.394||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||3.394|1.375|<0.001
71101498|NCT04003142|141710819|SUPERIORITY||Odds Ratio (OR)|3.074|||<|0.001||95.0|1.957|4.878||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||4.878|1.957|<0.001
71101499|NCT04003142|141710819|SUPERIORITY||Odds Ratio (OR)|2.05||||0.002||95.0|1.31|3.228||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||3.228|1.310|0.002
71101500|NCT04003142|141710819|SUPERIORITY||Odds Ratio (OR)|2.908|||<|0.001||95.0|1.856|4.599||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||4.599|1.856|<0.001
70925146|NCT04318548|141343574|OTHER||GMT Ratio|0.76|||||TWO_SIDED|95.0|0.64|0.91|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To assess the immune response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis M14459 (fHbp) strain at one month after the fisrt vaccination with rMenB+OMV NZ (at Day 31).||0.91|0.64|
71004861|NCT04716010|141517684|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004862|NCT04716010|141517684|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004863|NCT04716010|141517684|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71004864|NCT04716010|141517684|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71004865|NCT00679380|141517687|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|3.8||||0.2876|TWO_SIDED|95.0|-3.0|10.5|||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|All p-values were based on the Chi-square test; comparisons of budesonide MMX and placebo were conducted at the α = 0.025 level of significance and the comparison of Entocort EC and placebo were conducted at the α = 0.05 level of significance. The study was not powered to show statistical significance for Entocort EC versus budesonide MMX.||10.5|-3.0|0.2876
71004866|NCT00679380|141517687|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|12.9||||0.0047|TWO_SIDED|95.0|4.6|21.3|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||21.3|4.6|0.0047
71004867|NCT00679380|141517687|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|8.1||||0.0481|TWO_SIDED|95.0|0.4|15.9|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||15.9|0.4|0.0481
71004868|NCT00679380|141517688|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|-8.0||||0.2174|TWO_SIDED|95.0|-20.8||||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|Clinical improvement and endoscopic improvement were analyzed hierarchically. If at least one primary endpoint comparison was statistically significant, clinical improvement was to be compared between each budesonide MMX group and placebo at the α = 0.025 level of significance. If at least one comparison of clinical improvement was statistically significant, endoscopic improvement was to be compared between each budesonide MMX dose group and placebo at the α = 0.025 level of significance.||4.|-20.8|0.2174
71004869|NCT00679380|141517688|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|8.5||||0.2215|TWO_SIDED|95.0|-5.0|22.0|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||22.0|-5.0|0.2215
71004870|NCT00679380|141517688|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|-0.7||||0.9185|TWO_SIDED|95.0|-14.1|12.7|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||12.7|-14.1|0.9185
71004871|NCT00679380|141517689|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|5.4||||0.4293|TWO_SIDED|95.0|-8.0|18.8|||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|As per the hierarchical testing procedure for secondary endpoints, because clinical improvement was not statistically significant in the ITT population, formal statistical comparisons for endoscopic improvement between the 2 budesonide MMX groups and placebo were not conducted. The statistical comparison between the Entocort EC and placebo groups is shown here.||18.8|-8.0|0.4293
71044198|NCT04019054|141597715|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.001||||||a priori threshold for significance was p=0.05.|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of maximum distress as a function of step and timepoint. This multi-level model was generated using the menbreg function in Stata 16||||<.001
71044199|NCT04019054|141597715|SUPERIORITY||||||>|0.05||||||a priori threshold for significance of 0.05|Mixed Models Analysis|||This statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of maximum distress as a function of step and timepoint.||||>.05
71101501|NCT04003142|141710819|SUPERIORITY||Odds Ratio (OR)|2.113||||0.001||95.0|1.349|3.332||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||3.332|1.349|0.001
71004872|NCT00255008|141517691|SUPERIORITY_OR_OTHER||Proportion of patients (%)|80.0||||||95.0|28.36|99.49||||||||99.49|28.36|
71004873|NCT00255008|141517691|SUPERIORITY_OR_OTHER||Proportion of patients (%)|76.47||||||95.0|50.1|93.19||||||||93.19|50.10|
71004874|NCT00255008|141517691|SUPERIORITY_OR_OTHER||Proportion of patients (%)|87.5||||||95.0|47.35|99.48||||||||99.48|47.35|
71004875|NCT01833806|141517692|SUPERIORITY||Proportion Difference|0.78|||=|0.01|TWO_SIDED|95.0|0.58|0.98|||Binomial|||The alternative hypothesis test was that the proportion of Responders would be greater than the proportion of subjects experiencing pain progression. This PAS was powered to enroll 70 subjects based on the pivotal trial proportion of 18:8 (Responders:Pain progression). The study was closed at an enrollment of 32 subjects.||0.98|0.58|= 0.01
71004876|NCT02724111|141517695|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71004877|NCT02724111|141517696|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71004878|NCT02724111|141517697|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71004879|NCT02724111|141517698|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71004880|NCT02724111|141517699|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71101502|NCT04003142|141710819|SUPERIORITY||Odds Ratio (OR)|2.594|||<|0.001||95.0|1.653|4.104||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||4.104|1.653|<0.001
71101503|NCT04003142|141710819|SUPERIORITY||Odds Ratio (OR)|1.891||||0.005|TWO_SIDED|95.0|1.21|2.973||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||2.973|1.210|0.005
71101504|NCT04003142|141710819|SUPERIORITY||Odds Ratio (OR)|3.314|||<|0.001||95.0|2.108|5.265||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||5.265|2.108|<0.001
71101505|NCT04003142|141710819|SUPERIORITY||Odds Ratio (OR)|1.646||||0.027||95.0|1.06|2.566||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||2.566|1.060|0.027
71101506|NCT04003142|141710819|SUPERIORITY||Odds Ratio (OR)|2.347|||<|0.001||95.0|1.507|3.683||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||3.683|1.507|<0.001
71101507|NCT04003142|141710819|SUPERIORITY||Odds Ratio (OR)|1.792||||0.01|TWO_SIDED|95.0|1.153|2.799||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||2.799|1.153|0.010
71101508|NCT04003142|141710819|SUPERIORITY||Odds Ratio (OR)|2.819|||<|0.001||95.0|1.805|4.441||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||4.441|1.805|<0.001
71101509|NCT04003142|141710819|SUPERIORITY||Odds Ratio (OR)|2.357|||<|0.001||95.0|1.513|3.699||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||3.699|1.513|<0.001
71101510|NCT04003142|141710819|SUPERIORITY||Odds Ratio (OR)|3.131|||<|0.001||95.0|1.999|4.95||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||4.950|1.999|<0.001
71101511|NCT04003142|141710819|SUPERIORITY||Odds Ratio (OR)|1.373||||0.152||95.0|0.891|2.122||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||2.122|0.891|0.152
71101512|NCT04003142|141710819|SUPERIORITY||Odds Ratio (OR)|2.09|||<|0.001||95.0|1.351|3.252||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||3.252|1.351|<0.001
71004881|NCT02724111|141517700|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71004882|NCT02724111|141517701|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
71004883|NCT02724111|141517702|SUPERIORITY|||||||0.202|||||||Chi-squared|||||||0.202
71004884|NCT02996500|141517703|SUPERIORITY||Mean Difference (Net)|-7.83||||0.005|TWO_SIDED|95.0|-13.73|-1.97|||ANCOVA|Bayesian analysis of covariance (ANCOVA) modeling framework was used with baseline SDAI score as a covariate.||The confidence interval was credible interval in this analysis.||-1.97|-13.73|0.0050
71004885|NCT02996500|141517703|SUPERIORITY||Mean Difference (Net)|-8.96|||<|0.001|TWO_SIDED|95.0|-14.37|-3.66|||ANCOVA|Bayesian analysis of covariance (ANCOVA) modeling framework was used with baseline SDAI score as a covariate.||The confidence interval was credible interval in this analysis.||-3.66|-14.37|<0.001
71004886|NCT02996500|141517703|SUPERIORITY||Median Difference (Net)|-10.89|||<|0.001|TWO_SIDED|95.0|-16.36|-5.63|||ANCOVA|Bayesian analysis of covariance (ANCOVA) modeling framework was used with baseline SDAI score as a covariate.||The confidence interval was credible interval in this analysis.||-5.63|-16.36|<0.001
71004887|NCT02996500|141517703|SUPERIORITY||Mean Difference (Net)|-11.29|||<|0.001|TWO_SIDED|95.0|-16.62|-5.92|||ANCOVA|Bayesian analysis of covariance (ANCOVA) modeling framework was used with baseline SDAI score as a covariate.||The confidence interval was credible interval in this analysis.||-5.92|-16.62|<0.001
71004888|NCT02485860|141517737|SUPERIORITY|||||||0.094|||||||t-test, 2 sided|||||||0.094
71004889|NCT02402881|141517738|OTHER||Odds Ratio (OR)|1.0|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|We used generalized linear mixed-effects models with multiple outputation reiterated 1000 times to bootstrap the 95% CIs and the P values.||Our primary outcome was the proportion of non-administered doses of prescribed pharmacologic VTE prophylaxis. We compared rates of VTE prophylaxis non-administration pre-post-intervention. For estimating conditional odds ratios (ORs) and their 95% confidence intervals (CIs), the binomial family and a logit link were used; for estimating the conditional proportions, the Poisson family and a log link were used.||||<0.05
71004890|NCT02402881|141517739|OTHER||Odds Ratio (OR)|1.0|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|We used generalized linear mixed-effects models with multiple outputation reiterated 1000 times to bootstrap the 95% CIs and the P values.||Our secondary outcome was the proportion of VTE events. We compared rates of VTE prophylaxis nonadministration pre-post-intervention. For estimating conditional odds ratios (ORs) and their 95% CIs, the binomial family and a logit link were used; for estimating the conditional proportions, the Poisson family and a log link were used.||||<0.05
71004891|NCT03325010|141517740|SUPERIORITY||Mean Difference (Net)|-2.1|STANDARD_ERROR_OF_MEAN|1.5||0.1768|TWO_SIDED|95.0|-5.2|1.0||Nominal p-value is considered statistically significant if less than 0.05. To control for multiplicity, comparisons were tested sequentially.|Mixed Models Analysis|||||1.0|-5.2|0.1768
71004892|NCT03325010|141517741|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1095|TWO_SIDED|95.0|-0.6|0.1||To control for multiplicity, comparisons were tested sequentially. Nominal p-value for this outcome measure would only be evaluated for statistical significance if the primary outcome measure was statistically significant.|Mixed Models Analysis|||||0.1|-0.6|0.1095
71004893|NCT03325010|141517742|SUPERIORITY||Risk Difference (RD)|3.0||||0.819|TWO_SIDED|||||To control for multiplicity, comparisons were tested sequentially. Nominal p-value for this outcome measure would only be evaluated for statistical significance if the primary and preceding secondary outcome measures were statistically significant.|Cochran-Mantel-Haenszel|Stratified by baseline weight group (\<50 kg, ≥50 kg).||||||0.8190
71004894|NCT03325010|141517743|SUPERIORITY||Risk Difference (RD)|33.6||||0.0008|TWO_SIDED|||||To control for multiplicity, comparisons were tested sequentially. Nominal p-value for this outcome measure would only be evaluated for statistical significance if the primary and preceding secondary outcome measures were statistically significant.|Cochran-Mantel-Haenszel|Stratified by baseline weight group (\<50 kg, ≥50 kg)||||||0.0008
71044200|NCT04019054|141597715|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.001||||||a priori threshold for significance of p=0.05|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of maximum distress as a function of treatment group and timepoint. This multi-level model was generated using the menbreg function in Stata 16||||<.001
71044201|NCT04019054|141597715|SUPERIORITY||||||<|0.001||||||a priori threshold for significance of p=0.05|Mixed Models Analysis|||This statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of maximum distress as a function of group and timepoint.||||<.001
71044202|NCT04019054|141597715|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.001||||||a priori threshold for significance was p=0.05.|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of maximum distress as a function of step and group. This multi-level model was generated using the menbreg function in Stata 16||||<0.001
71044203|NCT04019054|141597715|SUPERIORITY|||||||0.024||||||a priori threshold for significance of p=0.05|Mixed Models Analysis|||This statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of maximum distress as a function of step and group.||||0.024
71044204|NCT05444543|141597716|SUPERIORITY||Odds Ratio (OR)|0.089||||0.57|TWO_SIDED||||||Chi-squared|||||||0.57
71044205|NCT05444543|141597717|SUPERIORITY||Odds Ratio (OR)|1.1|||>|0.99|TWO_SIDED||||||Chi-squared|||||||>0.99
71044206|NCT03877926|141597732|EQUIVALENCE|The 95% CIs for the Day 64 TNA NF50 GMT ratios between AV7909 Lot 1 and Lot 2 had to be within 0.5 to 2.0 equivalence margin.|Ratio|1.01|||||TWO_SIDED|95.0|0.93|1.1||||||||1.10|0.93|
71044207|NCT03877926|141597732|EQUIVALENCE|The 95% CIs for the Day 64 TNA NF50 GMT ratios between AV7909 Lot 1 and Lot 3 had to be within 0.5 to 2.0 equivalence margin.|Ratio|1.05|||||TWO_SIDED|95.0|0.96|1.14||||||||1.14|0.96|
71044208|NCT03877926|141597732|EQUIVALENCE|The 95% CIs for the Day 64 TNA NF50 GMT ratios between AV7909 Lot 2 and Lot 3 had to be within 0.5 to 2.0 equivalence margin.|Ratio|1.04|||||TWO_SIDED|95.0|0.95|1.13||||||||1.13|0.95|
71044209|NCT03877926|141597734|OTHER||Percentage of participants|66.3|||||TWO_SIDED|95.0|64.5|68.1||||||||68.1|64.5|
71101513|NCT04003142|141710820|SUPERIORITY||Odds Ratio (OR)|0.915||||0.951||95.0|0.036|23.464||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 1||23.464|0.036|0.951
71101514|NCT04003142|141710820|SUPERIORITY||Odds Ratio (OR)|2.889||||0.362|TWO_SIDED|95.0|0.364|58.864||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 1||58.864|0.364|0.362
71101515|NCT04003142|141710820|SUPERIORITY||Odds Ratio (OR)|2.775||||0.138||95.0|0.785|12.87||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||12.870|0.785|0.138
71101516|NCT04003142|141710820|SUPERIORITY||Odds Ratio (OR)|1.342||||0.704||95.0|0.291|6.914||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||6.914|0.291|0.704
71101517|NCT04003142|141710820|SUPERIORITY||Odds Ratio (OR)|0.798||||0.741||95.0|0.194|3.079||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||3.079|0.194|0.741
71101518|NCT04003142|141710820|SUPERIORITY||Odds Ratio (OR)|2.292||||0.134||95.0|0.809|7.443||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||7.443|0.809|0.134
71101519|NCT04003142|141710820|SUPERIORITY||Odds Ratio (OR)|3.474||||0.062||95.0|1.039|15.712||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||15.712|1.039|0.062
71004895|NCT00460525|141517751|SUPERIORITY_OR_OTHER||Vaccine Efficacy, VE=1-RR=1-exp(ß)|0.17||||0.175||95.0|-0.09|0.37||The a priori threshold for statistical significance was set at 0.05.|Regression, Cox|No adjustments were made.|Vaccine efficacy (VE) was defined as one minus the relative risk (RR), which was estimated by exponentiating the treatment parameter (ß) from the Cox model fit.|Time to first clinical malaria episode with significant parasitemia (2500/mm\^3) and temperature of greater than or equal to 37.5 degrees C was analyzed by fitting a Cox Proportional Hazards model. The null hypothesis of no vaccine efficacy was tested by the stratified log-rank test (score test). The point and interval estimates for vaccine efficacy were obtained by transforming those for treatment effect in the model.||0.37|-0.09|0.175
71004896|NCT00460525|141517753|SUPERIORITY_OR_OTHER||Vaccine Efficacy, VE=1-RR=1-exp(ß)|0.2||||0.068||95.0|-0.02|0.37||The a priori threshold for statistical significance was set at 0.05.|Poisson regression|No adjustments|Vaccine efficacy (VE) was defined as one minus the relative risk (RR), which was estimated by exponentiating the treatment parameter (ß) from the Poisson model fit.|Incidence density, defined as number of clinical malaria episodes per PYAR, was compared using Poisson regression. The null hypothesis of no vaccine efficacy was tested. The point and interval estimates for vaccine efficacy were obtained by transforming those for treatment effect in the model.||0.37|-0.02|0.068
71004897|NCT03073200|141517768|SUPERIORITY||Mean Difference (Final Values)|63.7|||<|0.001|TWO_SIDED|95.0|51.0|76.4|||Fisher Exact|||||76.4|51.0|<0.001
71004898|NCT03073200|141517769|SUPERIORITY||Mean Difference (Final Values)|70.2|||<|0.001|TWO_SIDED|95.0|59.3|81.0|||Fisher Exact|||||81|59.3|<0.001
71004899|NCT03073200|141517770|SUPERIORITY||Mean Difference (Final Values)|72.9|||<|0.001|TWO_SIDED|95.0|63.3|82.5|||Fisher Exact|||||82.5|63.3|<0.001
71004900|NCT03073200|141517771|SUPERIORITY||Mean Difference (Final Values)|50.4|||<|0.001|TWO_SIDED|95.0|40.6|60.2|||Fisher Exact|||||60.2|40.6|<0.001
71004901|NCT03073200|141517772|SUPERIORITY||Mean Difference (Final Values)|47.8|||<|0.001|TWO_SIDED|95.0|38.0|57.6|||Fisher Exact|||||57.6|38.0|<0.001
71004902|NCT03073200|141517773|SUPERIORITY||Mean Difference (Final Values)|45.0|||<|0.001|TWO_SIDED|95.0|33.2|56.8|||Fisher Exact|||||56.8|33.2|<0.001
71004903|NCT03073200|141517774|SUPERIORITY||Mean Difference (Final Values)|40.7|||<|0.001|TWO_SIDED|95.0|29.3|52.0|||Fisher Exact|||||52.0|29.3|<0.001
71004904|NCT03073200|141517775|SUPERIORITY||Mean Difference (Final Values)|51.1|||<|0.001|TWO_SIDED|95.0|35.3|66.9|||Fisher Exact|||||66.9|35.3|<0.001
71004905|NCT03073200|141517776|SUPERIORITY||Mean Difference (Final Values)|41.1|||<|0.001|TWO_SIDED|95.0|27.0|55.2|||Fisher Exact|||||55.2|27.0|<0.001
71004906|NCT03073200|141517777|SUPERIORITY||Mean Difference (Final Values)|-17.04|STANDARD_ERROR_OF_MEAN|5.747||0.005|TWO_SIDED|95.0|-28.7|-5.38|||Mixed Models Analysis|||||-5.38|-28.70|0.005
71004907|NCT03073200|141517778|SUPERIORITY||Mean Difference (Final Values)|-15.36|STANDARD_ERROR_OF_MEAN|1.682|<|0.001|TWO_SIDED|95.0|-18.69|-12.04|||Mixed Models Analysis|||||-12.04|-18.69|<0.001
71004908|NCT03073200|141517779|SUPERIORITY||Mean Difference (Final Values)|-12.01|STANDARD_DEVIATION|3.853||0.006|TWO_SIDED|95.0|-20.11|-3.9|||Mixed Models Analysis|||||-3.90|-20.11|0.006
71004909|NCT03073200|141517782|SUPERIORITY||Mean Difference (Final Values)|20.9||||0.089|TWO_SIDED|95.0|0.1|41.7|||Fisher Exact|||||41.7|0.1|0.089
71004910|NCT03073200|141517783|SUPERIORITY||Mean Difference (Final Values)|23.0||||0.07|TWO_SIDED|95.0|0.6|45.4|||Fisher Exact|||||45.4|0.6|0.070
71004911|NCT04757376|141517784|EQUIVALENCE|Statistical equivalence: the 90% confidence interval (CI) of the difference in the mean of the primary efficacy endpoint between treatment groups was entirely within an equivalence margin, \[- 1.45, + 1.45\].|Mean Difference (Final Values)|-0.19|||||TWO_SIDED|90.0|-0.76|0.38|||ANCOVA|ANCOVA included the treatment as a fixed effect and age, baseline LS-BMD T-score, and prior bisphosphonates therapy (Yes versus No) as covariates.||||0.38|-0.76|
71004912|NCT04474366|141517800|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|||||||0.72
71004913|NCT02875366|141517851|SUPERIORITY||Least Squares Mean Difference|-3.2||||0.3021|TWO_SIDED|95.0|-9.2|2.9|||Mixed effects model for repeated measure|||||2.9|-9.2|0.3021
71004914|NCT02875366|141517852|SUPERIORITY||Least Squares Mean Difference|-3.2||||0.1894|TWO_SIDED|95.0|-8.0|1.6|||Mixed effects model for repeated measure|||||1.6|-8.0|0.1894
71004915|NCT02875366|141517853|SUPERIORITY||Least Squares Mean Difference|-15.3||||0.2328|TWO_SIDED|95.0|-40.8|10.1|||Mixed effects model for repeated measure|||||10.1|-40.8|0.2328
71004916|NCT02875366|141517854|SUPERIORITY||Least Squares Mean Difference|-1.4||||0.1203|TWO_SIDED|95.0|-3.1|0.4|||Mixed effects model for repeated measure|||||0.4|-3.1|0.1203
71004917|NCT02875366|141517855|SUPERIORITY||Least Squares Mean Difference|-149.6||||0.0439|TWO_SIDED|95.0|-295.0|-4.2|||Mixed effects model for repeated measure|||||-4.2|-295.0|0.0439
71004918|NCT02875366|141517856|SUPERIORITY||Least Squares Mean Difference|-7.5||||0.2237|TWO_SIDED|95.0|-19.8|4.7|||Mixed effects model for repeated measure|||||4.7|-19.8|0.2237
71004919|NCT02875366|141517857|SUPERIORITY||Least Squares Mean Difference|-0.6||||0.0226|TWO_SIDED|95.0|-1.12|-0.09|||Mixed effects model for repeated measure|||||-0.09|-1.12|0.0226
71004920|NCT02875366|141517858|SUPERIORITY||Least Squares Mean Difference|-6.32||||0.0613|TWO_SIDED|95.0|-12.94|0.31|||Mixed effects model for repeated measure|||||0.31|-12.94|0.0613
71004921|NCT02875366|141517859|SUPERIORITY||Least Squares Mean Difference|0.3||||0.6409|TWO_SIDED|95.0|-0.9|1.5|||Mixed effects model for repeated measure|||||1.5|-0.9|0.6409
71004922|NCT02875366|141517860|SUPERIORITY||Least Squares Mean Difference|1.0||||0.5889|TWO_SIDED|95.0|-2.7|4.7|||Mixed effects model for repeated measure|||||4.7|-2.7|0.5889
71004923|NCT02875366|141517861|SUPERIORITY||Least Squares Mean Difference|3.4||||0.146|TWO_SIDED|95.0|-1.2|8.1|||Mixed effects model for repeated measure|||||8.1|-1.2|0.1460
71004924|NCT02875366|141517862|SUPERIORITY||Least Squares Mean Difference|3.5||||0.3091|TWO_SIDED|95.0|-3.4|10.4|||Mixed effects model for repeated measure|||||10.4|-3.4|0.3091
71004925|NCT02875366|141517863|SUPERIORITY||Least Squares Mean Difference|0.2||||0.3961|TWO_SIDED|95.0|-0.3|0.6|||Mixed effects model for repeated measure|||||0.6|-0.3|0.3961
71004926|NCT02875366|141517864|SUPERIORITY||Least Squares Mean Difference|0.9||||0.3905|TWO_SIDED|95.0|-1.2|3.1|||Mixed effects model for repeated measure|||||3.1|-1.2|0.3905
71004927|NCT02875366|141517865|SUPERIORITY||Least Squares Mean Difference|6.2||||0.1257|TWO_SIDED|95.0|-1.8|14.1|||Mixed effects model for repeated measure|||||14.1|-1.8|0.1257
71004928|NCT02141854|141517877|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.179||||0.0009|TWO_SIDED|95.0|0.074|0.285||Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the first in the sequence.||0.285|0.074|0.0009
71004929|NCT02141854|141517877|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.182||||0.001|TWO_SIDED|95.0|0.074|0.291||Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the second in the sequence.||0.291|0.074|0.0010
71044210|NCT03877926|141597735|NON_INFERIORITY|A non-inferiority margin of -15% was used for the difference in percentage of AV7909 participants (pooled from three AV7909 study groups \[Lot 1, 2, and 3\]) vs. BioThrax participants who achieved TNA NF50 ≥0.29 at Day 64. The success criterion was defined as the lower bound of 95% confidence interval of the difference in the percentage of AV7909 vs. BioThrax participants being greater than -15%.|Difference in percentage|24.5|||||TWO_SIDED|95.0|20.0|29.2||||||||29.2|20.0|
71044211|NCT03877926|141597736|OTHER|Relative risk of serious adverse events incidence between AV7909 (combined from all three AV7909 lots) and BioThrax.|Relative risk (AV7909/BioThrax)|2.5|||||TWO_SIDED|95.0|0.9|6.5|||||The 95% CI of the relative risk was derived using the Farrington-Manning relative risk score statistic.|||6.5|0.9|
71044212|NCT03877926|141597737|OTHER|Success criteria was defined as the lower bound for the 95% CI for the proportion of participants pooled from all three AV7909 study groups with TNA NF50 ≥0.15 to be ≥67%.|Percentage of participants|97.8|||||TWO_SIDED|95.0|97.2|98.3||||||||98.3|97.2|
71044213|NCT03877926|141597739|OTHER|Relative risk of adverse events of special interest (events of autoimmune etiology) incidence between AV7909 (combined from all three AV7909 lots) and BioThrax.|Relative risk (AV7909/BioThrax)|1.3|||||TWO_SIDED|95.0|0.3|5.0|||||The 95% CI of the relative risk was derived using the Farrington-Manning relative risk score statistic.|||5.0|0.3|
71044214|NCT01352182|141597756|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
71044215|NCT01352182|141597757|SUPERIORITY|||||||1||||||threshold for significance p\<0.05|Wilcoxon (Mann-Whitney)|||||||1.0
71044216|NCT01352182|141597758|SUPERIORITY|||||||0.154||||||threshold for significance p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.154
71044217|NCT01352182|141597759|SUPERIORITY|||||||0.683||||||significance threshold p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.683
71044218|NCT01352182|141597760|SUPERIORITY|||||||0.08||||||significance threshold p\<0.05|t-test, 2 sided|||||||0.08
71044219|NCT01352182|141597761|OTHER|linear regression|Slope|-1.44|STANDARD_ERROR_OF_MEAN|0.3741||0.003|TWO_SIDED||||||Regression, Linear|||||||0.003
71044220|NCT04625062|141597765|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.72|TWO_SIDED||||||paired t-test, two-tailed|df = 6|Traditional treatment condition - biofeedback treatment condition|||||.72
71044221|NCT00860743|141597766|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P values less than 0.05 are considered statistically significant in this study.|ANOVA|||||||0.001
71044222|NCT00860743|141597767|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||ANOVA|||||||0.2
71044223|NCT03827018|141597770|SUPERIORITY||Hazard Ratio (HR)|0.38||||0.0263|TWO_SIDED|95.0|0.15|0.92||Comparison of KPL-301 and placebo with respect to time to flare calculated by using a log-rank test stratified by randomization strata.|Log Rank||95% confidence interval was calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata.|||0.92|0.15|0.0263
71044224|NCT03827018|141597771|SUPERIORITY||Difference in proportions|33.3||||0.0038|TWO_SIDED|95.0|10.7|55.8||Two-sided p-value and 95% CI for the difference in sustained remission between two arms using normal approximation. Placebo arm is the reference.|normal approximation|||Secondary endpoints were analyzed in hierarchical order.||55.8|10.7|0.0038
71044225|NCT03827018|141597772|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.0277|TWO_SIDED|95.0|0.27|0.95||Calculated by using a log-rank test stratified by randomization strata.|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate, and stratified by randomization strata.|Secondary endpoints were analyzed in hierarchical order.||0.95|0.27|0.0277
71044226|NCT03827018|141597773|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.0378|TWO_SIDED|95.0|0.19|0.98||Calculated by using a log-rank test stratified by randomization strata.|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate, and stratified by randomization strata.|Secondary endpoints were analyzed in hierarchical order.||0.98|0.19|0.0378
71044227|NCT03827018|141597774|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.0651|TWO_SIDED|95.0|0.22|1.06||Calculated by using a log-rank test stratified by randomization strata.|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate, and stratified by randomization strata.|Secondary endpoints were analyzed in hierarchical order.||1.06|0.22|0.0651
71044228|NCT03827018|141597775|OTHER|Descriptive statistic|Least Squares (LS) means difference|-326.45||||0.0667|TWO_SIDED|95.0|-675.99|23.09||Calculated using ANCOVA with treatment arm and randomization strata as discrete variables, and corticosteroid starting dose as a continuous variable.|ANCOVA|||||23.09|-675.99|0.0667
71044229|NCT03827018|141597776|OTHER|Descriptive statistic|Difference in percentages|31.0||||0.0201|TWO_SIDED|95.0|11.1|50.8||95% CI and p-value are analyzed using a Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata|Cochran-Mantel-Haenszel|||||50.8|11.1|0.0201
71044230|NCT03827018|141597777|OTHER|Descriptive statistic|Difference in percentages|9.5||||0.5533|TWO_SIDED|95.0|-8.7|27.8||95% CI and p-value are analyzed using a Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata|Cochran-Mantel-Haenszel|||||27.8|-8.7|0.5533
70925147|NCT04318548|141343574|OTHER||GMT Ratio|0.62|||||TWO_SIDED|95.0|0.49|0.77|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To assess the immune response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis 96217 (NadA) strain at one month after the first vaccination with rMenB+OMV NZ (at Day 31).||0.77|0.49|
70925148|NCT04318548|141343574|OTHER||GMT Ratio|0.73|||||TWO_SIDED|95.0|0.58|0.91|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To assess the immune response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis NZ98/254 (PorA) strain at one month after the first vaccination with rMenB+OMV NZ (at Day 31).||0.91|0.58|
70925149|NCT04318548|141343574|OTHER||GMT Ratio|0.76|||||TWO_SIDED|95.0|0.64|0.9|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To assess the immune response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis M13520 (NHBA) at one month after the first vaccination with rMenB+OMV NZ (at Day 31).||0.90|0.64|
70925150|NCT04927065|141343587|OTHER||Geometric Mean Ratio (GMR)|2.5|||||TWO_SIDED|95.0|2.0|3.0|||||Omicron BA.1 Variant (B.1.1.529) nAB: Part A.2 versus Part A.1|||3.0|2.0|
70925151|NCT04927065|141343587|OTHER||GMR|2.0|||||TWO_SIDED|95.0|1.7|2.3|||||SARS-CoV-2 (D614G) nAb: Part A.2 versus Part A.1|||2.3|1.7|
71044231|NCT03827018|141597778|OTHER|Descriptive statistics|Difference in percentages|39.3||||0.0031|TWO_SIDED|95.0|17.2|61.3||95% CI and p-value are analyzed using a Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata|Cochran-Mantel-Haenszel|||||61.3|17.2|0.0031
71101520|NCT04003142|141710820|SUPERIORITY||Odds Ratio (OR)|6.184||||0.004||95.0|2.025|26.875||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||26.875|2.025|0.004
70925152|NCT04927065|141343588|OTHER||Geometric Mean Ratio (GMR)|6.3|||||TWO_SIDED|95.0|4.5|8.9|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part A.2 versus Part A.1|||8.9|4.5|
70925153|NCT04927065|141343588|OTHER||GMR|2.8|||||TWO_SIDED|95.0|2.1|3.6|||||SARS-CoV-2 (D614G) nAb: Part A.2 versus Part A.1|||3.6|2.1|
70925154|NCT04927065|141343589|OTHER||Percentage Difference|1.3|||||TWO_SIDED|95.0|-3.1|5.6|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part A.2 versus Part A.1|||5.6|-3.1|
70925155|NCT04927065|141343589|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|||||||SARS-CoV-2 (D614G) nAb: Part A.2 versus Part A.1|||||
70925156|NCT04927065|141343590|OTHER||Percentage Difference|-1.3|||||TWO_SIDED|95.0|-6.9|4.3|||||Omicron variant (B.1.1.529) nAb: Part A.2 versus Part A.1|||4.3|-6.9|
70925157|NCT04927065|141343590|OTHER||Percentage Difference|-2.6|||||TWO_SIDED|95.0|-9.6|4.5|||||SARS-CoV-2 (D614G) nAb: Part A.2 versus Part A.1|||4.5|-9.6|
70925158|NCT04927065|141343591|OTHER||Percentage Difference|12.9|||||TWO_SIDED|95.0|4.1|21.6|||||Omicron BA.1 variant (B.1.1.529) nAb: Part A.2 versus Part A.1|||21.6|4.1|
70925159|NCT04927065|141343591|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|||||||SARS-CoV-2 (D614G) nAb: Part A.2 versus Part A.1|||||
71044232|NCT03827018|141597779|OTHER|Descriptive statistics|Least Squares (LS) means difference|-380.82||||0.1629|TWO_SIDED|95.0|-919.66|158.02||Calculated using ANCOVA with treatment arm and randomization strata as discrete variables, and corticosteroid starting dose as a continuous variable|ANCOVA|||||158.02|-919.66|0.1629
71101521|NCT04003142|141710820|SUPERIORITY||Odds Ratio (OR)|4.217||||0.028|TWO_SIDED|95.0|1.305|18.806||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||18.806|1.305|0.028
70925160|NCT04927065|141343592|OTHER||Percentage Difference|2.9|||||TWO_SIDED|95.0|-11.4|17.1|||||Omicron BA.1 variant (B.1.1.529) nAb: Part A.2 versus Part A.1|||17.1|-11.4|
70925161|NCT04927065|141343592|OTHER||Percentage Difference|-7.1|||||TWO_SIDED|95.0|-21.6|7.3|||||SARS-CoV-2 (D614G) nAb: Part A.2 versus Part A.1|||7.3|-21.6|
70925162|NCT04927065|141343593|OTHER||GMR|1.777|||||TWO_SIDED|95.0|1.523|2.073|||||Omicron BA.1 Variant (B.1.1.529) nAb - Part F (Cohort 2): mRNA-1273.529 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||2.073|1.523|
70925163|NCT04927065|141343594|OTHER||Percentage Difference|0.6|||||TWO_SIDED|95.0|-1.7|3.0|||||Omicron BA.1 Variant (B.1.1.529) nAb - Part F (Cohort 2): mRNA-1273.529 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||3.0|-1.7|
70925164|NCT04927065|141343595|OTHER||Percentage Difference|17.9|||||TWO_SIDED|95.0|9.8|26.0|||||Omicron BA.1 Variant (B.1.1.529) nAb - Part F (Cohort 2): mRNA-1273.529 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||26.0|9.8|
70925165|NCT04927065|141343596|OTHER||GMR|1.744|||||TWO_SIDED|97.5|1.492|2.04|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||2.040|1.492|
70925166|NCT04927065|141343596|OTHER||GMR|1.211|||||TWO_SIDED|97.5|1.074|1.366|||||SARS-CoV-2 (D614G) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||1.366|1.074|
70925167|NCT04927065|141343597|OTHER||GMR|1.676|||||TWO_SIDED|97.5|1.396|2.013|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||2.013|1.396|
70925168|NCT04927065|141343597|OTHER||GMR|1.105|||||TWO_SIDED|97.5|0.97|1.26|||||SARS-CoV-2 (D614G) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||1.260|0.970|
70925169|NCT04927065|141343598|OTHER||Percentage Difference|1.5|||||TWO_SIDED|97.5|-1.1|4.1|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||4.1|-1.1|
70925170|NCT04927065|141343599|OTHER||Percentage Difference|21.5|||||TWO_SIDED|97.5|12.8|30.2|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||30.2|12.8|
71101522|NCT04003142|141710820|SUPERIORITY||Odds Ratio (OR)|3.802||||0.044||95.0|1.157|17.075||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||17.075|1.157|0.044
71101523|NCT04003142|141710820|SUPERIORITY||Odds Ratio (OR)|1.342||||0.519||95.0|0.551|3.382||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||3.382|0.551|0.519
71101524|NCT04003142|141710820|SUPERIORITY||Odds Ratio (OR)|1.961||||0.117||95.0|0.863|4.741||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||4.741|0.863|0.117
71004930|NCT02141854|141517877|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.326||||0|TWO_SIDED|95.0|0.221|0.431||Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the third in the sequence.||0.431|0.221|0.0000
71004931|NCT02141854|141517877|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.322||||0|TWO_SIDED|95.0|0.212|0.432||Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the fourth in the sequence.||0.432|0.212|0.0000
71044233|NCT00350402|141597789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.254|STANDARD_ERROR_OF_MEAN|2.028|<|0.001|TWO_SIDED|95.0|3.147|11.362|||t-test, 2 sided|df = 38; t = 3.576|Treatment effect size: Cohen's D =1.142|Hypothesis: Parkinson patients assigned to high intensity IMST will show greater improvement in facial movement (entropy) relative to those undergoing Sham IMST.||11.362|3.147|< 0.001
71044234|NCT00350402|141597790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.36|STANDARD_ERROR_OF_MEAN|4.955|<|0.459|TWO_SIDED|95.0|-16.41|3.68|||t-test, 2 sided|||Hypothesis: Scores on PDQ-39 would show bigger change for the IMST group than the Sham treatment group. The sample size was not powered for the PDQ-39 (but rather for the primary outcome variable).||3.68|-16.41|<0.459
71044235|NCT00350402|141597791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.426|STANDARD_ERROR_OF_MEAN|4.221|<|0.018|TWO_SIDED|95.0|1.874|18.978|||t-test, 2 sided|t-value = 2.47, with 37 df||Hypothesis: Changes in MIP following treatment would be greater for participants in the IMST versus the Sham treatment group. This is a validity check on for the IMST intervention.||18.978|1.874|<0.018
71044236|NCT00350402|141597792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.129|STANDARD_ERROR_OF_MEAN|2.492|<|0.047|TWO_SIDED|95.0|0.0834|10.17||No adjustment necessary|t-test, 2 sided|38 df, t= 2.058 However, due to inequality of variance (Levine test), the adjusted p-value = \<0.049, and adjusted df = 27.3||Hypothesis: Facial entropy changes would be greater in IMST group than sham treatment group. Sample size was based on preliminary data suggesting total N of 40 would be adequate for detecting change in entropy (of approximately 50%).||10.17|.0834|<0.047
71044237|NCT01192399|141597825|OTHER||||||<|0.0001|||||||Sign test|||||||<0.0001
71044238|NCT02443545|141597838|OTHER|One-sample t-test, to determine whether the change from baseline in LIC was significantly different from 0.||||||0|||||||t-test, 2 sided|||Change from baseline after 1 year of deferiprone therapy||||0.0000
71044239|NCT02443545|141597838|OTHER|One-sample t-test, to determine whether the change from baseline in LIC was significantly different from 0.||||||0|||||||t-test, 2 sided|||Change from baseline after 2 years of deferiprone therapy||||0.0000
71044240|NCT02443545|141597838|OTHER|One-sample t-test, to determine whether the change from baseline in LIC was significantly different from 0.||||||0|||||||t-test, 2 sided|||Change from baseline after 3 years of deferiprone therapy||||0.0000
71044241|NCT02443545|141597839|OTHER|One-sample t-test, to determine whether the change from baseline in MRI T2\* was significantly different from 0.||||||0.3146|||||||t-test, 2 sided|||Change from baseline after 1 year of deferiprone therapy||||0.3146
71044242|NCT02443545|141597839|OTHER|One-sample t-test, to determine whether the change from baseline in MRI T2\* was significantly different from 0.||||||0.9454|||||||t-test, 2 sided|||Change from baseline after 2 years of deferiprone therapy||||0.9454
71044243|NCT02443545|141597839|OTHER|One-sample t-test, to determine whether the change from baseline in MRI 2\* was significantly different from 0.||||||0.4336|||||||t-test, 2 sided|||Change from baseline after 3 years of deferiprone therapy||||0.4336
71044244|NCT02443545|141597840|OTHER|One-sample t-test, to determine whether the change from baseline in serum ferritin was significantly different from 0||||||0.9952|||||||t-test, 2 sided|||Change from baseline after 1 year of deferiprone therapy||||0.9952
71044245|NCT02443545|141597840|OTHER|One-sample t-test, to determine whether the change from baseline in serum ferritin was significantly different from 0||||||0.0008|||||||t-test, 2 sided|||Change from baseline after 2 years of deferiprone therapy||||0.0008
71044246|NCT02443545|141597840|OTHER|One-sample t-test, to determine whether the change from baseline in serum ferritin was significantly different from 0||||||0.042|||||||t-test, 2 sided|||Change from baseline after 3 years of deferiprone therapy||||0.0420
71004932|NCT02141854|141517878|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.276||||0|TWO_SIDED|95.0|0.191|0.361||Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the fifth in the sequence.||0.361|0.191|0.0000
71004933|NCT02141854|141517878|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.274||||0|TWO_SIDED|95.0|0.189|0.36||Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the sixth in the sequence.||0.360|0.189|0.0000
71004934|NCT02141854|141517878|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.183||||0|TWO_SIDED|95.0|0.098|0.268||Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the seventh in the sequence.||0.268|0.098|0.0000
71004935|NCT02141854|141517878|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.123||||0.0047|TWO_SIDED|95.0|0.038|0.208||Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the eighth in the sequence.||0.208|0.038|0.0047
71004936|NCT02141854|141517879|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|18.45||||0|TWO_SIDED|95.0|11.751|25.15||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||25.150|11.751|0.0000
71004937|NCT02141854|141517879|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|16.718||||0|TWO_SIDED|95.0|9.988|23.449||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||23.449|9.988|0.0000
71044247|NCT00536484|141597841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0002||95.0|-1.1|-0.4||Significance level p \<0.05|ANCOVA|Terms for treatment, center and baseline as covariate and baseline by treatment interaction.|The LS mean difference \& 95% CI were calculated at mean baseline = 12.9 (centered baseline used in model)|Null hypothesis: the mean change from baseline in micturitions per 24 hours in the fesoterodine group is the same as in the placebo group at Week 12. A sample size of 350 in each arm had at least 85% power to detect a difference of 0.8 between flexible dose fesoterodine \& placebo assuming a standard deviation of 3.52 using a 2-sample t-test with a 0.05 2-sided significance level. Accounting for 10% of randomized subjects not having the primary endpoint data, 390 subjects were needed in each arm||-0.4|-1.1|0.0002
71044248|NCT00536484|141597842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0136||95.0|-0.8|-0.1||Significance level p \<0.05|ANCOVA|Terms for center, treatment, baseline covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 2 minus Baseline||-0.1|-0.8|0.0136
71044249|NCT00536484|141597842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0002||95.0|-1.1|-0.3||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 6 minus Baseline||-0.3|-1.1|0.0002
71044250|NCT00536484|141597843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.1057||95.0|-0.9|0.1||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 2 minus Baseline||0.1|-0.9|0.1057
71044251|NCT00536484|141597843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.0338||95.0|-1.1|0.0||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 6 minus Baseline||-0.0|-1.1|0.0338
71044252|NCT00536484|141597843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.3||0.0003||95.0|-1.5|-0.5||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 12 minus Baseline||-0.5|-1.5|0.0003
71044253|NCT00536484|141597844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1666||95.0|-0.6|0.1||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 2 minus Baseline||0.1|-0.6|0.1666
71044254|NCT00536484|141597844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0506||95.0|-0.8|0.0||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 6 minus Baseline||0.0|-0.8|0.0506
71044255|NCT00536484|141597844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0014||95.0|-1.0|-0.2||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 12 minus Baseline||-0.2|-1.0|0.0014
71004938|NCT02141854|141517879|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|31.221||||0|TWO_SIDED|95.0|24.513|37.93||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||37.930|24.513|0.0000
71004939|NCT02141854|141517879|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|29.597||||0|TWO_SIDED|95.0|22.839|36.354||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||36.354|22.839|0.0000
71004940|NCT02141854|141517879|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|12.771||||0.0002|TWO_SIDED|95.0|6.179|19.363||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||19.363|6.179|0.0002
71004941|NCT02141854|141517879|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|12.879||||0.0002|TWO_SIDED|95.0|6.216|19.541||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||19.541|6.216|0.0002
71004942|NCT02141854|141517879|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|11.146||||0.001|TWO_SIDED|95.0|4.511|17.782||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||17.782|4.511|0.0010
71004943|NCT02141854|141517880|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.156||||0.001|TWO_SIDED|95.0|-0.248|-0.063||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.063|-0.248|0.0010
71004944|NCT02141854|141517880|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.195||||0|TWO_SIDED|95.0|-0.288|-0.102||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.102|-0.288|0.0000
71004945|NCT02141854|141517880|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.304||||0|TWO_SIDED|95.0|-0.397|-0.212||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.212|-0.397|0.0000
71004946|NCT02141854|141517880|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.277||||0|TWO_SIDED|95.0|-0.37|-0.184||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.184|-0.370|0.0000
71004947|NCT02141854|141517880|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.149||||0.0014|TWO_SIDED|95.0|-0.239|-0.058||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.058|-0.239|0.0014
71044256|NCT00536484|141597845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.2054||95.0|-0.4|0.1||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 2 minus Baseline||0.1|-0.4|0.2054
71044257|NCT00536484|141597845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0225||95.0|-0.6|0.0||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 6 minus Baseline||-0.0|-0.6|0.0225
71044258|NCT00536484|141597845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0167||95.0|-0.6|-0.1||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 12 minus Baseline||-0.1|-0.6|0.0167
71044259|NCT00536484|141597846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8019||95.0|-0.2|0.1||Significance level p \<0.05|ANOVA|||Week 2 minus Baseline||0.1|-0.2|0.8019
71044260|NCT00536484|141597846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3881||95.0|-0.2|0.1||Significance level p \<0.05|ANOVA|||Week 6 minus Baseline||0.1|-0.2|0.3881
71004948|NCT02141854|141517880|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.082||||0.0818|TWO_SIDED|95.0|-0.174|0.01||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.010|-0.174|0.0818
71004949|NCT02141854|141517880|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.121||||0.0094|TWO_SIDED|95.0|-0.213|-0.03||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.030|-0.213|0.0094
71004950|NCT02141854|141517881|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.702||||0|TWO_SIDED|95.0|-1.001|-0.403||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.403|-1.001|0.0000
71004951|NCT02141854|141517881|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.607||||0.0001|TWO_SIDED|95.0|-0.908|-0.307||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.307|-0.908|0.0001
71004952|NCT02141854|141517881|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-1.066||||0|TWO_SIDED|95.0|-1.365|-0.766||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.766|-1.365|0.0000
71004953|NCT02141854|141517881|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.989||||0|TWO_SIDED|95.0|-1.291|-0.686||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.686|-1.291|0.0000
71004954|NCT02141854|141517881|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.364||||0.016|TWO_SIDED|95.0|-0.659|-0.068||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.068|-0.659|0.0160
71004955|NCT02141854|141517881|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.382||||0.0124|TWO_SIDED|95.0|-0.681|-0.083||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.083|-0.681|0.0124
71044261|NCT00536484|141597846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.324||95.0|-0.2|0.1||Significance level p \<0.05|ANOVA|||Week 12 minus Baseline||0.1|-0.2|0.3240
71044262|NCT00536484|141597847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8279||95.0|-0.2|0.1||Significance level p \<0.05|ANOVA|||Week 2 minus Baseline||0.1|-0.2|0.8279
71044263|NCT00536484|141597847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.5059||95.0|-0.2|0.1||Significance level p \<0.05|ANOVA|||Week 6 minus Baseline||0.1|-0.2|0.5059
71044264|NCT00536484|141597847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0806||95.0|-0.4|0.0||Significance level p \<0.05|ANOVA|||Week 12 minus Baseline||0.0|-0.4|0.0806
71044265|NCT00536484|141597848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.0203||95.0|-3.2|-0.3||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 2 minus Baseline||-0.3|-3.2|0.0203
71044266|NCT00536484|141597848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.8||0.0007||95.0|-4.2|-1.1||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 6 minus Baseline||-1.1|-4.2|0.0007
71044267|NCT00536484|141597848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001||95.0|-4.9|-1.7||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 12 minus Baseline||-1.7|-4.9|<0.0001
71044268|NCT00536484|141597849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.8|STANDARD_ERROR_OF_MEAN|1.5|<|0.0001||95.0|-10.7|-4.9||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 12 minus Baseline||-4.9|-10.7|<0.0001
71004956|NCT02141854|141517881|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.287||||0.0588|TWO_SIDED|95.0|-0.584|0.011||Significance level of 0.05.|Wilcoxon (Mann-Whitney)|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.011|-0.584|0.0588
71004957|NCT02141854|141517882|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||||||Significance level of 0.05.|Log Rank|||||||0.0001
71004958|NCT02141854|141517882|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Significance level of 0.05.|Log Rank|||||||<.0001
71004959|NCT02141854|141517882|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||||||Significance level of 0.05.|Log Rank|||||||0.0003
71044269|NCT00536484|141597850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.4|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001||95.0|5.3|11.5||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|"Week 12 minus Baseline~Concern domain"||11.5|5.3|<0.0001
71044270|NCT00536484|141597850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001||95.0|3.9|10.2||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|"Week 12 minus Baseline~Coping domain"||10.2|3.9|<0.0001
71044271|NCT00536484|141597850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|1.6||0.0036||95.0|1.5|7.8||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate||"Week 12 minus Baseline~Sleep domain"||7.8|1.5|0.0036
71044272|NCT00536484|141597850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7|STANDARD_ERROR_OF_MEAN|1.1||0.0007||95.0|1.6|5.8||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|"Week 12 minus Baseline~Social interaction domain"||5.8|1.6|0.0007
71101525|NCT04003142|141710820|SUPERIORITY||Odds Ratio (OR)|1.471||||0.393||95.0|0.612|3.687||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||3.687|0.612|0.393
71004960|NCT02141854|141517882|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Significance level of 0.05.|Log Rank|||||||<.0001
71004961|NCT02141854|141517882|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7203||||||Significance level of 0.05.|Log Rank|||||||0.7203
71004962|NCT02141854|141517882|SUPERIORITY_OR_OTHER_LEGACY|||||||0.996||||||Significance level of 0.05.|Log Rank|||||||0.9960
71004963|NCT02141854|141517882|SUPERIORITY_OR_OTHER_LEGACY|||||||0.325||||||Significance level of 0.05.|Log Rank|||||||0.3250
71044273|NCT00536484|141597850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2|STANDARD_ERROR_OF_MEAN|1.3|<|0.0001||95.0|3.6|8.9||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|"Week 12 minus Baseline~HRQL scale score total"||8.9|3.6|<0.0001
71004964|NCT02141854|141517883|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.473||||0|TWO_SIDED|95.0|0.269|0.677||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.677|0.269|0.0000
71044274|NCT00536484|141597851|SUPERIORITY_OR_OTHER|||||||0.0087||95.0||||Significance level p \<0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 2||||0.0087
71101526|NCT04003142|141710820|SUPERIORITY||Odds Ratio (OR)|2.087||||0.086||95.0|0.923|5.043||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||5.043|0.923|0.086
71004965|NCT02141854|141517883|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.428||||0|TWO_SIDED|95.0|0.224|0.632||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.632|0.224|0.0000
71004966|NCT02141854|141517883|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.623||||0|TWO_SIDED|95.0|0.418|0.828||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.828|0.418|0.0000
71004967|NCT02141854|141517883|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.681||||0|TWO_SIDED|95.0|0.478|0.885||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.885|0.478|0.0000
71101527|NCT04003142|141710820|SUPERIORITY||Odds Ratio (OR)|1.774||||0.168||95.0|0.798|4.143||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||4.143|0.798|0.168
71004968|NCT02141854|141517883|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.15||||0.149|TWO_SIDED|95.0|-0.054|0.354||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.354|-0.054|0.1490
71004969|NCT02141854|141517883|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.253||||0.0143|TWO_SIDED|95.0|0.051|0.455||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.455|0.051|0.0143
71004970|NCT02141854|141517883|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.209||||0.0435|TWO_SIDED|95.0|0.006|0.411||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.411|0.006|0.0435
71004971|NCT04363944|141517913|EQUIVALENCE|A paired-t test comparing performance of vertical bowl transfer at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||<|0.001||||||Comparing the change in performing a vertical bowl transfer, the calculated p-value for this activity was \<.001|t-test, 2 sided|||mRehab task vertical bowl transfer- moving the bowl vertically up and down||||<0.001
71004972|NCT04363944|141517913|EQUIVALENCE|A paired-t test comparing performance of moving the bowl horizontally at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.001||||||Comparing the change in performing a horizontal bowl transfer, the calculated p-value for this activity was .001|t-test, 2 sided|||mRehab task horizontal bowl transfer- moving the bowl horizontally||||=.001
71004973|NCT04363944|141517913|EQUIVALENCE|A paired-t test comparing performance of the vertical mug transfer at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.003||||||Comparing the change in performing a vertical mug transfer, the calculated p-value for this activity was .003|t-test, 2 sided|||mRehab task vertical mug transfer- moving the mug vertically up and down||||=.003
71004974|NCT04363944|141517913|EQUIVALENCE|A paired-t test comparing performance of the horizontal mug transfer at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.009||||||Comparing the change in performing a horizontal mug transfer, the calculated p-value for this activity was .009|t-test, 2 sided|||mRehab task horizontal mug transfer- moving the mug horizontally||||=.009
71004975|NCT04363944|141517913|EQUIVALENCE|A paired-t test comparing performance of the simulated sip at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.933|||||||t-test, 2 sided|A paired-t test comparing performance at the beginning of the 6 week in-home program to the end of the 6 week in-home program.||mRehab task simulate sip- bring mug within one inch of mouth as if taking a drink||||=.933
71004976|NCT04363944|141517913|EQUIVALENCE|A paired-t test comparing performance of entering a phone number at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.136|||||||t-test, 2 sided|||mRehab task enter phone number||||=.136
71004977|NCT04363944|141517913|EQUIVALENCE|A paired-t test comparing performance of the quick tap at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.005|||||||t-test, 2 sided|||mRehab task quick tap- tapping a moving object on the phone screen||||=.005
71004978|NCT04363944|141517914|EQUIVALENCE|Paired t-tests comparing performance at the first session of in-home training to the last session of in-home training were conducted.|||||=|0.228|||||||t-test, 2 sided|||mRehab task vertical bowl transfer- moving bowl vertically up and down||||=.228
71044275|NCT00536484|141597851|SUPERIORITY_OR_OTHER|||||||0.0008||95.0||||Significance level p \<0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 6||||0.0008
71044276|NCT00536484|141597851|SUPERIORITY_OR_OTHER|||||||0.0006||95.0||||Significance level p \<0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 12||||0.0006
71044277|NCT00536484|141597852|SUPERIORITY_OR_OTHER|||||||0.0129||95.0||||Significance level p \<0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 2||||0.0129
71044278|NCT00536484|141597852|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||Significance level p \<0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 6||||0.0100
71044279|NCT00536484|141597852|SUPERIORITY_OR_OTHER|||||||0.0009||95.0||||Significance level p \<0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 12||||0.0009
71044280|NCT00536484|141597853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.9|-0.4||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 2 minus Baseline||-0.4|-0.9|<0.0001
71004979|NCT04363944|141517914|EQUIVALENCE|A paired-t test comparing performance at the beginning of the 6 week in-home program to the end of the 6 week in-home program.||||||0.196|||||||t-test, 2 sided|||mRehab task horizontal bowl- bowl moved horizontally||||.196
71004980|NCT04363944|141517914|EQUIVALENCE|A paired-t test comparing performance at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.024|||||||t-test, 2 sided|||mRehab task Vertical Mug- Mug moved vertically and then placed on counter||||=.024
71004981|NCT04363944|141517914|EQUIVALENCE|A paired-t test comparing performance at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.038|||||||t-test, 2 sided|||mRehab task horizontal mug transfer- moving the mug horizontally||||=.038
71004982|NCT04363944|141517914|EQUIVALENCE|A paired-t test comparing performance at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.306||||||calculated p-value greater than .05|t-test, 2 sided|||mRehab task simulate sip||||=.306
71101528|NCT04003142|141710820|SUPERIORITY||Odds Ratio (OR)|2.374||||0.03||95.0|1.112|5.41||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||5.410|1.112|0.030
71101529|NCT04003142|141710820|SUPERIORITY||Odds Ratio (OR)|1.605||||0.287|TWO_SIDED|95.0|0.681|3.971||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||3.971|0.681|0.287
71004983|NCT04363944|141517915|EQUIVALENCE|The average of the WMFT from testing sessions pre intervention (week 1 and approximately week 2) was compared to the WMFT immediately following mRehab home intervention (week 8) using a two tailed paired t-test.|||||=|0.017||||||calculated p-value .017|t-test, 2 sided|||||||=.017
70925171|NCT04927065|141343600|OTHER||Percentage Difference|1.8|||||TWO_SIDED|97.5|-1.9|5.6|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||5.6|-1.9|
70925172|NCT04927065|141343601|OTHER||Percentage Difference|20.6|||||TWO_SIDED|97.5|12.4|28.7|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||28.7|12.4|
70925173|NCT04927065|141343602|OTHER||GMR|6.412|||||TWO_SIDED|95.0|5.369|7.658|||||Omicron Variant (BA.4/BA.5) nAb: Part H mRNA-1273.222 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||7.658|5.369|
70925174|NCT04927065|141343602|OTHER||GMR|1.967|||||TWO_SIDED|95.0|1.708|2.265|||||SARS-CoV-2 (D614G) nAb: Part H mRNA-1273.222 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||2.265|1.708|
70925175|NCT04927065|141343603|OTHER||Percentage Difference|12.2|||||TWO_SIDED|95.0|6.9|17.4|||||Omicron Variant (BA.4/BA.5) nAb: Part H mRNA-1273.222 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||17.4|6.9|
70925176|NCT04927065|141343603|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|||||||SARS-CoV-2 (D614G) nAb: Part H mRNA-1273.222 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||||
70925177|NCT04927065|141343604|OTHER||Percentage Difference|54.7|||||TWO_SIDED|95.0|47.5|61.8|||||Omicron Variant (BA.4/BA.5) nAb: Part H mRNA-1273.222 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||61.8|47.5|
70925178|NCT04927065|141343604|OTHER||Percentage Difference|37.6|||||TWO_SIDED|95.0|29.3|45.9|||||SARS-CoV-2 (D614G) nAb: Part H mRNA-1273.222 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||45.9|29.3|
71004984|NCT04363944|141517916|EQUIVALENCE|Test, the scores from the first and second in-laboratory visits were averaged to account for variability in the performance of individuals with stroke. This averaged preintervention score was compared with the third in-laboratory visit to assess the immediate change in performance following use of mRehab.|||||=|0.019|||||||t-test, 2 sided|||Compared pre and post intervention data for participants using mRehab for a 6 week home program.||||=.019
71004985|NCT02903966|141517939|OTHER||Least Square Mean Difference|-0.18|||||TWO_SIDED|95.0|-1.23|0.87|||||Analysis performed using a Mixed Models Repeated Measures (MMRM) model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and baseline value by visit interactions|||0.87|-1.23|
71004986|NCT02903966|141517940|OTHER||Least Square Mean Difference|0.02|||||TWO_SIDED|95.0|-1.18|1.22|||||Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and baseline value by visit interactions|||1.22|-1.18|
71004987|NCT02903966|141517941|OTHER||Least Square Mean Difference|-0.05|||||TWO_SIDED|95.0|-4.11|4.02|||||Day 15. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and Baseline value by visit interactions|||4.02|-4.11|
71004988|NCT02903966|141517941|OTHER||Least Square Mean Difference|-3.17|||||TWO_SIDED|95.0|-5.99|-0.35|||||Day 29. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and Baseline value by visit interactions|||-0.35|-5.99|
71004989|NCT02903966|141517941|OTHER||Least Square Mean Difference|-1.69|||||TWO_SIDED|95.0|-6.26|2.88|||||Day 43. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and Baseline value by visit interactions|||2.88|-6.26|
71044281|NCT00536484|141597853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-1.1|-0.5||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 6 minus Baseline||-0.5|-1.1|<0.0001
70925179|NCT04927065|141343613|OTHER||GMR|0.836|||||TWO_SIDED|95.0|0.745|0.938|||||SARS-CoV-2 (D614G) nAb: Part F (Cohort 2): mRNA-1273.529 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||0.938|0.745|
70925180|NCT04927065|141343614|OTHER||SRR Difference|0.0|||||TWO_SIDED|95.0|||||||SARS-CoV-2 (D614G) nAb: Part F (Cohort 2): mRNA-1273.529 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg 95% CI could not be calculated due to the SRR difference is 0.|||||
70925181|NCT04927065|141343615|OTHER||SRR Difference|-13.1|||||TWO_SIDED|95.0|-21.2|-5.0|||||SARS-CoV-2 (D614G) nAb: Part F (Cohort 2): mRNA-1273.529 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||-5.0|-21.2|
70925182|NCT04927065|141343616|OTHER||SRR Difference|0.0|||||TWO_SIDED|97.5|||||||SARS-CoV-2 (D614G) nAb at Day 29: Part G versus Part F (Cohort 2) mRNA-1273 95% CI could not be calculated due to the SRR difference is 0.|||||
71004990|NCT02903966|141517942|OTHER||Least Square Mean Difference|0.29|||||TWO_SIDED|95.0|-4.01|4.59|||||Day 57. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and Baseline value by visit interactions|||4.59|-4.01|
70925183|NCT04927065|141343616|OTHER||SRR Difference|0.9|||||TWO_SIDED|97.5|-1.6|3.5|||||SARS-CoV-2 (D614G) nAb at Day 91: Part G versus Part F (Cohort 2) mRNA-1273|||3.5|-1.6|
70925184|NCT04927065|141343616|OTHER||SRR Difference|-0.1|||||TWO_SIDED|95.0|-2.3|2.1|||||SARS-CoV-2 (D614G) nAb at Day 181: Part G versus Part F (Cohort 2) mRNA-1273|||2.1|-2.3|
70925185|NCT04927065|141343616|OTHER||SRR Difference|-1.9|||||TWO_SIDED|95.0|-5.3|1.5|||||SARS-CoV-2 (D614G) nAb at Day 366: Part G versus Part F (Cohort 2) mRNA-1273|||1.5|-5.3|
70925186|NCT04927065|141343617|OTHER||SRR Difference|10.9|||||TWO_SIDED|97.5|1.7|20.1|||||SARS-CoV-2 (D614G) nAb at Day 29: Part G versus Part F (Cohort 2) mRNA-1273|||20.1|1.7|
70925187|NCT04927065|141343617|OTHER||SRR Difference|9.2|||||TWO_SIDED|97.5|1.4|17.0|||||SARS-CoV-2 (D614G) nAb at Day 91: Part G versus Part F (Cohort 2) mRNA-1273|||17.0|1.4|
70925188|NCT04927065|141343617|OTHER||SRR Difference|10.1|||||TWO_SIDED|95.0|3.0|17.2|||||SARS-CoV-2 (D614G) nAb at Day 181: Part G versus Part F (Cohort 2) mRNA-1273|||17.2|3.0|
70925189|NCT04927065|141343617|OTHER||SRR Difference|4.3|||||TWO_SIDED|95.0|-5.0|13.6|||||SARS-CoV-2 (D614G) nAb at Day 366: Part G versus Part F (Cohort 2) mRNA-1273|||13.6|-5.0|
70925190|NCT04927065|141343619|OTHER||GMR|1.818|||||TWO_SIDED|95.0|1.469|2.249|||||SARS-CoV-2 (D614G) nAb: Part H versus Part F (Cohort 2) mRNA-1273|||2.249|1.469|
70925191|NCT04927065|141343621|OTHER||SRR Difference|0.0|||||TWO_SIDED|95.0|-2.6|2.5|||||SARS-CoV-2 (D614G) nAb: Part H versus Part F (Cohort 2) mRNA-1273|||2.5|-2.6|
70925192|NCT04927065|141343623|OTHER||SRR Difference|25.5|||||TWO_SIDED|95.0|16.9|34.1|||||SARS-CoV-2 (D614G) nAb: Part H versus Part F (Cohort 2) mRNA-1273|||34.1|16.9|
70925193|NCT04927065|141343624|OTHER||SRR Difference|5.0|||||TWO_SIDED|95.0|0.3|9.8|||||Omicron BA.1 Variant (B.1.1.529) nAb at Day 181: Part G versus Part F (Cohort 2) mRNA-1273|||9.8|0.3|
71044282|NCT00536484|141597853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-1.3|-0.7||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 12 minus Baseline||-0.7|-1.3|<0.0001
70925194|NCT04927065|141343624|OTHER||SRR Difference|5.6|||||TWO_SIDED|95.0|-0.3|11.5|||||Omicron BA.1 Variant (B.1.1.529) nAb at Day 366: Part G versus Part F (Cohort 2) mRNA-1273|||11.5|-0.3|
71004991|NCT02903966|141517942|OTHER||Least Square Mean Difference|0.11|||||TWO_SIDED|95.0|-3.64|3.85|||||Day 71. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and Baseline value by visit interactions|||3.85|-3.64|
70925195|NCT04927065|141343625|OTHER||SRR Difference|14.5|||||TWO_SIDED|95.0|6.7|22.3|||||Omicron BA.1 Variant (B.1.1.529) nAb at Day 181: Part G versus Part F (Cohort 2) mRNA-1273|||22.3|6.7|
71004992|NCT02903966|141517942|OTHER||Least Square Mean Difference|1.12|||||TWO_SIDED|95.0|-2.87|5.1|||||Day 85. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and Baseline value by visit interactions|||5.10|-2.87|
71004993|NCT02903966|141517943|OTHER||Ratio|0.7|||||TWO_SIDED|95.0|0.27|1.8|||||Day 15. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, log-transformed Baseline value, and the treatment by visit and log-transformed baseline value by visit interactions.|||1.80|0.27|
71004994|NCT02903966|141517943|OTHER||Ratio|0.44|||||TWO_SIDED|95.0|0.2|1.0|||||Day 29. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, log-transformed Baseline value, and the treatment by visit and log-transformed baseline value by visit interactions.|||1.00|0.20|
70925196|NCT04927065|141343625|OTHER||SRR Difference|8.0|||||TWO_SIDED|95.0|-2.1|18.0|||||Omicron BA.1 Variant (B.1.1.529) nAb at Day 366: Part G versus Part F (Cohort 2) mRNA-1273|||18.0|-2.1|
70925197|NCT04927065|141343626|OTHER||GMR|1.637|||||TWO_SIDED|95.0|1.243|2.155|||||SARS-CoV-2 (B.1.1.529) nAb at Day 181: Part G versus Part F (Cohort 2) mRNA-1273|||2.155|1.243|
71044283|NCT01506908|141597854|SUPERIORITY_OR_OTHER||Least squares means difference|-15.9|||<|0.0001|TWO_SIDED|95.0|-21.6|-10.2|||ANCOVA||Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered the population's change from post-cue baseline in craving score mean to be equal in both treatment groups at 5 minutes||-10.2|-21.6|<0.0001
71044284|NCT01506908|141597855|SUPERIORITY_OR_OTHER||Least squares means difference|-4.2||||0.0511|TWO_SIDED|95.0|-8.4|0.0|||ANCOVA||Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered the population's change from post-cue baseline in craving score mean to be equal in both treatment groups at 1 minute.||0.0|-8.4|0.0511
71044285|NCT01506908|141597856|SUPERIORITY_OR_OTHER||Least squares means difference|-11.6|||<|0.0001|TWO_SIDED|95.0|-16.7|-6.4|||ANCOVA||Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered the population's change from post-cue baseline in craving score mean to be equal in both treatment groups at 3 minutes.||-6.4|-16.7|<0.0001
71044286|NCT01506908|141597857|SUPERIORITY_OR_OTHER||Least squares means difference|-17.8|||<|0.0001|TWO_SIDED|95.0|-23.8|-11.7|||ANCOVA||Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered the population's change from post-cue baseline in craving score mean to be equal in both treatment groups at 7 minutes.||-11.7|-23.8|<0.0001
71044287|NCT01506908|141597858|SUPERIORITY_OR_OTHER||Least square mean difference|-17.9|||<|0.0001|TWO_SIDED|95.0|-24.4|-11.4|||ANCOVA||Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered the population's change from post-cue baseline in craving score mean to be equal in both treatment groups at 10 minutes.||-11.4|-24.4|<0.0001
71044288|NCT00562120|141597875|SUPERIORITY_OR_OTHER|||||||0.302|TWO_SIDED|||||P-value was based on one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.302
71044289|NCT00562120|141597875|SUPERIORITY_OR_OTHER|||||||0.134|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.134
71044290|NCT00562120|141597875|SUPERIORITY_OR_OTHER|||||||0.229|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.229
71044291|NCT00562120|141597875|SUPERIORITY_OR_OTHER|||||||0.544|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.544
71044292|NCT00562120|141597875|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.710
71044293|NCT00562120|141597875|SUPERIORITY_OR_OTHER|||||||0.816|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.816
71044294|NCT00562120|141597876|SUPERIORITY_OR_OTHER|||||||0.269|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.269
71044295|NCT00562120|141597876|SUPERIORITY_OR_OTHER|||||||0.097|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.097
71044296|NCT00562120|141597876|SUPERIORITY_OR_OTHER|||||||0.252|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.252
71044297|NCT00562120|141597876|SUPERIORITY_OR_OTHER|||||||0.479|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.479
71044298|NCT00562120|141597876|SUPERIORITY_OR_OTHER|||||||0.521|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.521
71044299|NCT00562120|141597876|SUPERIORITY_OR_OTHER|||||||0.952|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.952
71044300|NCT00562120|141597877|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.130
71004995|NCT02903966|141517943|OTHER||Ratio|0.23|||||TWO_SIDED|95.0|0.09|0.62|||||Day 43. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, log-transformed Baseline value, and the treatment by visit and log-transformed baseline value by visit interactions.|||0.62|0.09|
71004996|NCT02903966|141517944|OTHER||Ratio|0.49|||||TWO_SIDED|95.0|0.25|0.97|||||Day 57. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, log-transformed Baseline value, and the treatment by visit and log-transformed baseline value by visit interactions.|||0.97|0.25|
71004997|NCT02903966|141517944|OTHER||Ratio|0.56|||||TWO_SIDED|95.0|0.2|1.57|||||Day 71. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, log-transformed Baseline value, and the treatment by visit and log-transformed baseline value by visit interactions.|||1.57|0.20|
71004998|NCT02903966|141517944|OTHER||Ratio|0.82|||||TWO_SIDED|95.0|0.31|2.18|||||Day 85. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, log-transformed Baseline value, and the treatment by visit and log-transformed baseline value by visit interactions.|||2.18|0.31|
71044301|NCT00562120|141597877|SUPERIORITY_OR_OTHER|||||||0.663|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.663
71044302|NCT00562120|141597877|SUPERIORITY_OR_OTHER|||||||0.138|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.138
71044303|NCT00562120|141597877|SUPERIORITY_OR_OTHER|||||||0.124|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.124
71044304|NCT00562120|141597877|SUPERIORITY_OR_OTHER|||||||0.134|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.134
71044305|NCT00562120|141597877|SUPERIORITY_OR_OTHER|||||||0.978|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.978
71044306|NCT00562120|141597878|SUPERIORITY_OR_OTHER|||||||0.357|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.357
71044307|NCT00562120|141597878|SUPERIORITY_OR_OTHER|||||||0.952|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.952
71044308|NCT00562120|141597878|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.480
71101530|NCT04003142|141710820|SUPERIORITY||Odds Ratio (OR)|2.108||||0.08||95.0|0.936|5.076||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||5.076|0.936|0.080
71101531|NCT04003142|141710820|SUPERIORITY||Odds Ratio (OR)|1.599||||0.247|TWO_SIDED|95.0|0.73|3.636||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||3.636|0.730|0.247
71101532|NCT04003142|141710820|SUPERIORITY||Odds Ratio (OR)|2.481||||0.017||95.0|1.201|5.441||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||5.441|1.201|0.017
71101533|NCT04003142|141710820|SUPERIORITY||Odds Ratio (OR)|1.728||||0.212||95.0|0.744|4.236||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||4.236|0.744|0.212
71101534|NCT04003142|141710820|SUPERIORITY||Odds Ratio (OR)|3.536||||0.002||95.0|1.666|8.207||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||8.207|1.666|0.002
71101535|NCT04003142|141710820|SUPERIORITY||Odds Ratio (OR)|1.701||||0.225||95.0|0.733|4.169||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||4.169|0.733|0.225
71101536|NCT04003142|141710820|SUPERIORITY||Odds Ratio (OR)|3.049||||0.006||95.0|1.42|7.125||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||7.125|1.420|0.006
71101537|NCT03382873|141710842|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71101538|NCT03382873|141710843|SUPERIORITY|||||||0.0001|||||||ANOVA|Intervention sequence and sex were used as independent predictors in the model.||Compares the change for the GLB/GLB intervention sequence to the GLB+/GLB+ intervention sequence (the primary comparison of interest)||||0.0001
71101539|NCT03382873|141710844|SUPERIORITY|||||||0.9476|||||||ANOVA|Intervention sequence and sex used as independent predictors in the model.||Comparison of the GLB/GLB intervention sequence to the GLB+/GLB+ intervention sequence (the primary comparison of interest).||||0.9476
71101540|NCT03382873|141710845|SUPERIORITY|||||||0.0112|||||||ANOVA|Treatment group, time and their interaction were fixed effects and participants were random effects||||||0.0112
71101541|NCT03382873|141710846|SUPERIORITY|||||||0.9085|||||||ANOVA|Intervention sequence and sex used as independent predictors in the model.||Comparison of GLB/GLB intervention sequence to GLB+/GLB+ intervention sequence (the primary comparison of interest).||||0.9085
71101542|NCT03382873|141710847|SUPERIORITY|||||||0.2063|||||||ANOVA|Intervention sequence and sex used as independent predictors in the model.||Comparison between the GLB/GLB intervention sequence and the GLB+/GLB+ intervention sequence (the primary comparison of interest)||||0.2063
71101543|NCT02592655|141710848|SUPERIORITY_OR_OTHER|||||||0.002||||||Significance thresh hold: 0.05.|McNemar|||"Null hypothesis is that one windlass tourniquet is just as likely to occlude arterial flow as the 10 cm wide tourniquet tape.~Participant count of 18 to accommodate for missing windlass tourniquet ultrasound data."||||0.002
71101544|NCT02592655|141710848|SUPERIORITY_OR_OTHER|||||||0.008||||||Significance thresh hold: 0.05.|McNemar|||"Null hypothesis is that one windlass tourniquet is just as likely to occlude arterial flow as two windlass tourniquets.~Participant count of 18 to accommodate for missing windlass tourniquet ultrasound data."||||0.008
71101545|NCT02592655|141710848|SUPERIORITY_OR_OTHER|||||||0.5||||||Significance thresh hold: 0.05.|McNemar|||"Null hypothesis is that the 10 cm wide tourniquet tape is just as likely to occlude arterial flow as using two windlass tourniquets.~Participant count of 18 to accommodate for missing windlass tourniquet ultrasound data."||||0.5
71101546|NCT02592655|141710848|SUPERIORITY_OR_OTHER|||||||0.5||||||Significance thresh hold: 0.05.|McNemar|||"Null hypothesis is that using the pneumatic tourniquet is just as likely to occlude arterial flow as using two windlass tourniquets.~Participant count of 17 to accommodate for missing ultrasound data."||||0.5
71101547|NCT03996395|141710851|OTHER||Descriptive statistic|71.0|STANDARD_DEVIATION|23.0|||TWO_SIDED|||||||||||||
71101548|NCT05135754|141710885|SUPERIORITY||Risk Ratio (RR)|0.59||||0.046|TWO_SIDED|95.0|0.35|0.99|||Mixed Models Analysis|||||0.99|0.35|0.046
71101549|NCT05135754|141710886|SUPERIORITY||Mean Difference (Final Values)|6.61|||<|0.001|TWO_SIDED|95.0|3.45|9.78|||Mixed Models Analysis|||||9.78|3.45|<0.001
71101550|NCT05135754|141710887|SUPERIORITY||Mean Difference (Final Values)|20.01|||<|0.001|TWO_SIDED|95.0|15.02|25.0|||Mixed Models Analysis|||||25.00|15.02|<0.001
71101551|NCT05135754|141710888|SUPERIORITY||Mean Difference (Final Values)|6.32|||<|0.001|TWO_SIDED|95.0|2.71|9.94|||Mixed Models Analysis|||||9.94|2.71|<0.001
71101552|NCT05135754|141710889|SUPERIORITY||Mean Difference (Final Values)|14.3|||<|0.001|TWO_SIDED|95.0|8.26|20.35|||Mixed Models Analysis|||||20.35|8.26|<0.001
71101553|NCT05135754|141710890|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.075|TWO_SIDED||||||Mixed Models Analysis|||||||0.075
71101554|NCT05135754|141710891|SUPERIORITY||Mean Difference (Final Values)|4.68||||0.004|TWO_SIDED|95.0|1.55|7.81|||Mixed Models Analysis|||||7.81|1.55|0.004
71044309|NCT00562120|141597878|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.043
71044310|NCT00562120|141597878|SUPERIORITY_OR_OTHER|||||||0.087|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.087
71044311|NCT00562120|141597878|SUPERIORITY_OR_OTHER|||||||0.753|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.753
71044312|NCT00562120|141597879|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.011
71044313|NCT00562120|141597879|SUPERIORITY_OR_OTHER|||||||0.127|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.127
71044314|NCT00562120|141597879|SUPERIORITY_OR_OTHER|||||||0.103|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.103
71044315|NCT00562120|141597879|SUPERIORITY_OR_OTHER|||||||0.218|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.218
71101555|NCT02757963|141710915|OTHER||Proportion|0.883|||||TWO_SIDED|95.0|0.849|0.912|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|||0.912|0.849|
71044316|NCT00562120|141597879|SUPERIORITY_OR_OTHER|||||||0.905|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.905
71044317|NCT00562120|141597879|SUPERIORITY_OR_OTHER|||||||0.273|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.273
71044318|NCT00562120|141597879|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.000
71044319|NCT00562120|141597879|SUPERIORITY_OR_OTHER|||||||0.055|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.055
71044320|NCT00562120|141597879|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.012
71044321|NCT00562120|141597879|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.048
71044322|NCT00562120|141597879|SUPERIORITY_OR_OTHER|||||||0.496|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.496
71044323|NCT00562120|141597879|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.190
71101556|NCT02757963|141710916|OTHER||Proportion|0.877|||||TWO_SIDED|95.0|0.846|0.904|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8||0.904|0.846|
71101557|NCT02757963|141710916|OTHER||Proportion|0.889|||||TWO_SIDED|95.0|0.854|0.917|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8 and BPE/BPO \>=3||0.917|0.854|
71044324|NCT00562120|141597879|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.000
71044325|NCT00562120|141597879|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.019
71044326|NCT00562120|141597879|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.009
71044327|NCT00562120|141597879|SUPERIORITY_OR_OTHER|||||||0.061|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.061
71044328|NCT00562120|141597879|SUPERIORITY_OR_OTHER|||||||0.778|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.778
71044329|NCT00562120|141597879|SUPERIORITY_OR_OTHER|||||||0.102|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.102
71044330|NCT00562120|141597880|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.000
71101558|NCT02757963|141710916|OTHER||Proportion|0.873|||||TWO_SIDED|95.0|0.843|0.9|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8 or BPE/BPO \>=3||0.900|0.843|
71101559|NCT02757963|141710917|OTHER||Proportion|0.9|||||TWO_SIDED|95.0|0.87|0.926|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8||0.926|0.870|
71101560|NCT02757963|141710917|OTHER||Proportion|0.907|||||TWO_SIDED|95.0|0.873|0.934|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm BPE/BPO \>=3||0.934|0.873|
71044331|NCT00562120|141597880|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.000
71044332|NCT00562120|141597880|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.000
71101561|NCT02757963|141710917|OTHER||Proportion|0.907|||||TWO_SIDED|95.0|0.873|0.935|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8 and BPE/BPO \>=3||0.935|0.873|
71044333|NCT00562120|141597880|SUPERIORITY_OR_OTHER|||||||0.217|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.217
71044334|NCT00562120|141597880|SUPERIORITY_OR_OTHER|||||||0.156|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.156
71044335|NCT00562120|141597880|SUPERIORITY_OR_OTHER|||||||0.848|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.848
71101562|NCT02757963|141710917|OTHER||Proportion|0.9|||||TWO_SIDED|95.0|0.87|0.925|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm PSS \>=8 or BPE/BPO \>=3||0.925|0.870|
71101563|NCT02757963|141710918|OTHER||Proportion|0.362|||||TWO_SIDED|95.0|0.337|0.386|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8||0.386|0.337|
71101564|NCT02757963|141710918|OTHER||Proportion|0.368|||||TWO_SIDED|95.0|0.341|0.395|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm BPE/BPO \>=3||0.395|0.341|
70925198|NCT04927065|141343626|OTHER||GMR|1.373|||||TWO_SIDED|95.0|0.953|1.976|||||SARS-CoV-2 (B.1.1.529) nAb at Day 366: Part G versus Part F (Cohort 2) mRNA-1273|||1.976|0.953|
71101565|NCT02757963|141710918|OTHER||Proportion|0.377|||||TWO_SIDED|95.0|0.349|0.406|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8 and BPE/BPO \>=3||0.406|0.349|
70925199|NCT04927065|141343626|OTHER||GMR|1.271|||||TWO_SIDED|95.0|1.051|1.537|||||SARS-CoV-2 (D614G) nAb at Day 181: Part G versus Part F (Cohort 2) mRNA-1273|||1.537|1.051|
71101566|NCT02757963|141710918|OTHER||Proportion|0.355|||||TWO_SIDED|95.0|0.332|0.379|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8 or BPE/BPO \>=3||0.379|0.332|
71101567|NCT02757963|141710919|OTHER||Kappa statistic|0.55|||||TWO_SIDED|95.0|0.51|0.58||||||||0.58|0.51|
71101568|NCT00057577|141710953|SUPERIORITY_OR_OTHER||||||=|0.038|TWO_SIDED||||||Subdistribution hazard model|||||||=.038
71101569|NCT00057577|141710954|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Subdistribution hazard model|||||||<0.01
71044336|NCT00545688|141597882|SUPERIORITY_OR_OTHER||Difference in Response rates|16.82||||0.0094|TWO_SIDED|95.0|3.5|30.1||Cochran-Mantel-Haenszel test stratified by breast cancer type (operable, locally advanced, or inflammatory) and estrogen and or progesterone positivity (either positive versus both negative).|Cochran-Mantel-Haenszel|||||30.1|3.5|0.0094
71044337|NCT00545688|141597882|SUPERIORITY_OR_OTHER|||||||0.0141|TWO_SIDED|||||P-value from Cochran-Mantel-Haenszel test, with Simes multiplicity adjustment.|Cochran-Mantel-Haenszel|||||||0.0141
71044338|NCT00545688|141597882|SUPERIORITY_OR_OTHER||Difference in Response rates|-12.15||||0.0198|TWO_SIDED|95.0|-23.8|-0.5||Cochran-Mantel-Haenszel test stratified by breast cancer type (operable, locally advanced, or inflammatory) and estrogen and or progesterone positivity (either positive versus both negative).|Cochran-Mantel-Haenszel|||||-0.5|-23.8|0.0198
71044339|NCT00545688|141597882|SUPERIORITY_OR_OTHER|||||||0.0198|TWO_SIDED|||||P-value from Cochran-Mantel-Haenszel test, with Simes multiplicity adjustment.|Cochran-Mantel-Haenszel|||||||0.0198
71101570|NCT03109769|141710957|SUPERIORITY|||||||0.0444|||||||Wilcoxon (Mann-Whitney)|||"The sample size was calculated as 44 participants. Sample size calculation was carried out through a pilot study on 30 participants with the group I mean=1.31, SD=0.39 and group II mean=1.62, SD=0.30, with ⍺=0.05 and 80% power.~The null hypothesis was: there is no difference in plaque index and gingival index between verbal oral hygiene instructions and oral hygiene instructions using mobile applications in patients with orthodontic fixed appliances."||||0.0444
71044340|NCT00545688|141597882|SUPERIORITY_OR_OTHER||Difference in Response rates|-21.84||||0.001|TWO_SIDED|95.0|-35.1|-8.5||Cochran-Mantel-Haenszel test stratified by breast cancer type (operable, locally advanced, or inflammatory) and estrogen and or progesterone positivity (either positive versus both negative).|Cochran-Mantel-Haenszel|||||-8.5|-35.1|0.0010
71044341|NCT00545688|141597882|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||P-value from Cochran-Mantel-Haenszel test, with Simes multiplicity adjustment.|Cochran-Mantel-Haenszel|||||||0.0030
71044342|NCT00545688|141597897|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.2983|TWO_SIDED|95.0|0.34|1.4|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|PFS||1.40|0.34|0.2983
71044343|NCT00545688|141597897|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.4722|TWO_SIDED|95.0|0.68|2.3|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|PFS||2.30|0.68|0.4722
71101571|NCT03109769|141710957|SUPERIORITY||Mean Difference (Net)|-0.1373||||0.0002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Difference in plaque index within the first group (mobile phone application) at 4 weeks compared to baseline.~The mean difference was calculated as follows:~plaque index at 4 weeks - plaque index at baseline"|||||0.0002
71101572|NCT03109769|141710957|SUPERIORITY||Median Difference (Final Values)|0.0932||||0.0283|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Difference in plaque index within the second group (verbal oral hygiene instructions) at 4 weeks compared to baseline.~The mean difference was calculated as follows:~plaque index at 4 weeks - plaque index at baseline"|||||0.0283
71101573|NCT03109769|141710958|SUPERIORITY|||||||0.0283|||||||Wilcoxon (Mann-Whitney)|||"The sample size was calculated as 44 participants. Sample size calculation was carried out through a pilot study on 30 participants with the group I mean=1.31, SD=0.39 and group II mean=1.62, SD=0.30, with ⍺=0.05 and 80% power.~The null hypothesis was: there is no difference in plaque index and gingival index between verbal oral hygiene instructions and oral hygiene instructions using mobile applications in patients with orthodontic fixed appliances."||||0.0283
70925200|NCT04927065|141343626|OTHER||GMR|1.101|||||TWO_SIDED|95.0|0.83|1.461|||||SARS-CoV-2 (D614G) nAb at Day 366: Part G versus Part F (Cohort 2) mRNA-1273|||1.461|0.830|
70925201|NCT03378570|141343627|OTHER|comparative effectiveness trial||||||0.945|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures.||||0.945
70925202|NCT03378570|141343628|OTHER|comparative effectiveness trial||||||0.828|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures.||||0.828
70925203|NCT03378570|141343629|OTHER|comparative effectiveness trial||||||0.252|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures.||||0.252
70925204|NCT03378570|141343630|OTHER|||||||0.505||||||p value for response rate|Chi-squared|||"The null hypothesis of this study was that there would be no differences between targets across all measures.~A power analysis revealed that a total sample size of 144 would have 80% power when testing for differences between target groups at alpha = 0.05. Accounting for potential attrition, the study conservatively planned to enroll 200 participants, with a planned interim analysis after 100 participants were randomized."||||0.505
70925205|NCT03378570|141343630|OTHER|||||||0.888||||||p value for remission rate|Chi-squared|||"The null hypothesis of this study was that there would be no differences between targets across all measures.~A power analysis revealed that a total sample size of 144 would have 80% power when testing for differences between target groups at alpha = 0.05. Accounting for potential attrition, the study conservatively planned to enroll 200 participants, with a planned interim analysis after 100 participants were randomized."||||0.888
70925206|NCT03378570|141343631|OTHER|||||||0.994|||||||Chi-squared|p value for response rates||"The null hypothesis of this study was that there would be no differences between targets across all measures.~A power analysis revealed that a total sample size of 144 would have 80% power when testing for differences between target groups at alpha = 0.05. Accounting for potential attrition, the study conservatively planned to enroll 200 participants, with a planned interim analysis after 100 participants were randomized."||||0.994
70925207|NCT03378570|141343631|OTHER|||||||0.911|||||||Chi-squared|p value for remission rates||"The null hypothesis of this study was that there would be no differences between targets across all measures.~A power analysis revealed that a total sample size of 144 would have 80% power when testing for differences between target groups at alpha = 0.05. Accounting for potential attrition, the study conservatively planned to enroll 200 participants, with a planned interim analysis after 100 participants were randomized."||||0.911
70925208|NCT03378570|141343632|OTHER|||||||0.778|||||||t-test, 2 sided|||"The null hypothesis of this study was that there would be no differences between targets across all measures.~A power analysis revealed that a total sample size of 144 would have 80% power when testing for differences between target groups at alpha = 0.05. Accounting for potential attrition, the study conservatively planned to enroll 200 participants, with a planned interim analysis after 100 participants were randomized."||||0.778
70925209|NCT03378570|141343633|OTHER|comparative effectiveness trial||||||0.951|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures.||||.951
70925210|NCT03378570|141343634|OTHER|comparative effectiveness trial||||||0.278|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Positive Affect.||||.278
70925211|NCT03378570|141343634|OTHER|comparative effectiveness trial||||||0.024|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, General Life Satisfaction.||||.024
70925212|NCT03378570|141343634|OTHER|comparative effectiveness trial||||||0.439|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Meaning \& Purpose.||||.439
70925213|NCT03378570|141343634|OTHER|comparative effectiveness trial||||||0.025|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Emotional Support.||||.025
70925214|NCT03378570|141343634|OTHER|comparative effectiveness trial||||||0.007|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Instrumental Support.||||.007
70925215|NCT03378570|141343634|OTHER|comparative effectiveness trial||||||0.014|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Friendship.||||.014
70925216|NCT03378570|141343634|OTHER|comparative effectiveness trial||||||0.398|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Loneliness.||||.398
70925217|NCT03378570|141343634|OTHER|comparative effectiveness trial||||||0.064|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Perceived Rejection.||||.064
70925218|NCT03378570|141343634|OTHER|comparative effectiveness trial||||||0.368|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Perceived Hostility.||||.368
70925219|NCT03378570|141343634|OTHER|comparative effectiveness trial||||||0.504|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Self-Efficacy.||||.504
70925220|NCT03378570|141343634|OTHER|comparative effectiveness trial||||||0.371|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Perceived Stress.||||.371
70925221|NCT03378570|141343634|OTHER|comparative effectiveness trial||||||0.438|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Fear-Affect.||||.438
70925222|NCT03378570|141343634|OTHER|comparative effectiveness trial||||||0.096|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Fear-Somatic Arousal.||||.096
70925223|NCT03378570|141343634|OTHER|comparative effectiveness trial||||||0.132|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Sadness.||||.132
71044344|NCT00545688|141597897|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.05||||0.0268|TWO_SIDED|95.0|1.07|3.93|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|PFS||3.93|1.07|0.0268
71044345|NCT00545688|141597897|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.1805|TWO_SIDED|95.0|0.28|1.27|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|DFS||1.27|0.28|0.1805
71044346|NCT00545688|141597897|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.5901|TWO_SIDED|95.0|0.42|1.64|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|DFS||1.64|0.42|0.5901
71044347|NCT00545688|141597897|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.16||||0.025|TWO_SIDED|95.0|1.08|4.32|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|DFS||4.32|1.08|0.0250
71044348|NCT00784134|141597927|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.027||||0.554|TWO_SIDED|95.0|-0.062|0.115|||Chi-squared|||||0.115|-0.062|0.554
71044349|NCT00784134|141597927|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.465|TWO_SIDED|95.0|0.75|1.87||Multivariable logit model adjusted for age, GCS, thalamus, stability ICH volume and stability IVH volume.|Multivariable Logit Model|||||1.87|0.75|0.465
71044350|NCT00784134|141597928|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.484|TWO_SIDED|95.0|0.63|1.25||Generalized ordered logit model adjusted for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical) compares odds ratio for mRS score \> K v. \<= K for K = 1 - 4; Alt v. Sal.|Generalized ordered Logit Model|||||1.25|0.63|0.484
71044351|NCT00784134|141597928|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.44|||<|0.001|TWO_SIDED|95.0|0.28|0.71||The same generalized ordered logit model, adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical), compares odds ratio for mRS score greater than 5 versus mRS score equal or less than 5 (dead versus alive).|Generalized ordered Logit Model|||||0.71|0.28|<0.001
71044352|NCT00784134|141597929|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.026||||0.552|TWO_SIDED|95.0|-0.059|0.111|||Chi-squared|||||0.111|-0.059|0.552
71044353|NCT00784134|141597929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.35|TWO_SIDED|95.0|0.8|1.9||Multivariable logit model adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).|Multivariable Logit Model|||||1.90|0.80|0.350
71044354|NCT00784134|141597930|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.428|TWO_SIDED|95.0|0.78|1.8||Random effects model with site as random effect adjusted for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).|Random Effects Model|||||1.80|0.78|0.428
71044355|NCT00784134|141597931|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.384|TWO_SIDED|95.0|0.75|2.1|||Generalized Estimating Equation Model|Generalized estimating equation model adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).||Logit mRS scores 0-3 at 30 days||2.10|0.75|0.384
71044356|NCT00784134|141597931|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.964|TWO_SIDED|95.0|0.62|1.64|||Generalized Estimating Equation Model|Generalized estimating equation model adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).||Logit mRS scores 0-3 at 180 days||1.64|0.62|0.964
71044357|NCT00784134|141597932|SUPERIORITY_OR_OTHER|||||||0.0056|||||||Log Rank|||||||0.0056
71044358|NCT00784134|141597933|SUPERIORITY_OR_OTHER||||||<|0.001|||||||AUC/ Logit Model|||||||<0.001
71044359|NCT00784134|141597934|SUPERIORITY_OR_OTHER|||||||0.771|||||||Kruskal-Wallis|||||||0.771
71044360|NCT00784134|141597935|SUPERIORITY_OR_OTHER|||||||0.098|||||||Kruskal-Wallis|||||||0.098
71044361|NCT00784134|141597936|SUPERIORITY_OR_OTHER|||||||0.45|||||||Generalized Linear Models|||||||0.450
71044362|NCT00784134|141597937|SUPERIORITY_OR_OTHER|||||||0.501|||||||Chi-squared|||||||0.501
71044363|NCT00784134|141597938|SUPERIORITY_OR_OTHER|||||||0.795|||||||Chi-squared|||||||0.795
71101574|NCT03109769|141710958|SUPERIORITY||Mean Difference (Net)|-0.1177||||0.0002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Difference in gingival index within the first group (mobile phone application) at 4 weeks compared to baseline.~The mean difference was calculated as follows:~gingival index at 4 weeks - gingival index at baseline"|||||0.0002
71101575|NCT03109769|141710958|SUPERIORITY||Mean Difference (Net)|0.1014||||0.4809|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Difference in gingival index within the second group (verbal oral hygiene instructions) at 4 weeks compared to baseline.~The mean difference was calculated as follows:~gingival index at 4 weeks - gingival index at baseline"|||||0.4809
70925224|NCT03378570|141343634|OTHER|comparative effectiveness trial||||||0.951|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Anger-Affect.||||.951
71044364|NCT00784134|141597939|SUPERIORITY_OR_OTHER|||||||0.784|||||||Chi-squared|||||||0.784
71044365|NCT00784134|141597940|SUPERIORITY_OR_OTHER|||||||0.592|||||||Chi-squared|||||||0.592
71044366|NCT00784134|141597941|SUPERIORITY_OR_OTHER|||||||0.105|||||||Chi-squared|||||||0.105
71044367|NCT00784134|141597942|SUPERIORITY_OR_OTHER|||||||0.152|||||||Chi-squared|||||||0.152
71044368|NCT00784134|141597943|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.055||||0.055|TWO_SIDED|95.0|-0.111|0.008|||Fisher Exact|||||0.008|-0.111|0.055
71044369|NCT00784134|141597944|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.035||||0.202|TWO_SIDED|95.0|-0.084|0.014|||Fisher Exact|||||0.014|-0.084|0.202
71044370|NCT00784134|141597945|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.004||||0.771|TWO_SIDED|95.0|-0.022|0.03|||Fisher Exact|||||0.030|-0.022|0.771
71044371|NCT00784134|141597946|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.004||||0.811|TWO_SIDED|95.0|-0.028|0.036|||Fisher Exact|||||0.036|-0.028|0.811
71044372|NCT00784134|141597947|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.144||||0.0017|TWO_SIDED|95.0|-0.23|-0.057|||Fisher Exact|||||-0.057|-0.230|0.0017
71044373|NCT00784134|141597948|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.006|TWO_SIDED|95.0|0.41|0.86|||Cox Proportional Hazards Model|Adjusted Cox Proportional Hazards Model adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).||||0.86|0.41|0.006
71044374|NCT00784134|141597949|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.064||||0.41|TWO_SIDED|95.0|-0.088|0.217|||Chi-squared|||||0.217|-0.088|0.410
71044375|NCT00784134|141597950|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.016||||0.781|TWO_SIDED|95.0|-0.096|0.128|||Chi-squared|||||0.128|-0.096|0.781
71044376|NCT00784134|141597951|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.02||||0.773|TWO_SIDED|95.0|-0.113|0.152|||Chi-squared|||||0.152|-0.113|0.773
71044377|NCT00784134|141597952|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.032||||0.587|TWO_SIDED|95.0|-0.085|0.151|||Chi-squared|||||0.151|-0.085|0.587
71044378|NCT00784134|141597953|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.015||||0.775|TWO_SIDED|95.0|-0.09|0.121|||Chi-squared|||||0.121|-0.09|0.775
71044379|NCT00784134|141597954|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.019||||0.808|TWO_SIDED|95.0|-0.132|0.169|||Chi-squared|||||0.169|-0.132|0.808
71044380|NCT00784134|141597955|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.033||||0.625|TWO_SIDED|95.0|-0.165|0.099|||Chi-squared|||||0.099|-0.165|0.625
71044381|NCT00784134|141597956|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.087||||0.191|TWO_SIDED|95.0|-0.043|0.218|||Chi-squared|||||0.218|-0.043|0.191
71044382|NCT00784134|141597957|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0066||||0.949|TWO_SIDED|95.0|-0.197|0.211|||Chi-squared|||||0.211|-0.197|0.949
71044383|NCT00784134|141597958|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.014||||0.812|TWO_SIDED|95.0|-0.098|0.126|||Chi-squared|||||0.126|-0.098|0.812
71044384|NCT00784134|141597959|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.059||||0.394|TWO_SIDED|95.0|-0.076|0.194|||Chi-squared|||||0.194|-0.076|0.394
71044385|NCT00784134|141597960|SUPERIORITY_OR_OTHER|||||||0.312|||||||Wilcoxon (Mann-Whitney)|||||||0.312
71044386|NCT00784134|141597961|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.075||||0.087|TWO_SIDED|95.0|-0.011|0.16||Analysis of dichotomous eGOS, comparing Upper Severe Disability scores to Lower Severe Disability scores|Chi-squared|||||0.160|-0.011|0.087
71044387|NCT00784134|141597961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.54||||0.064|TWO_SIDED|95.0|0.98|2.43||Adjusted Multivariable Logit Model comparing eGOS scores of Upper Severe Disability or greater versus Lower Severe Disability and worse; Alteplase versus Saline|Multivariable Logit Model|||||2.43|0.98|0.064
71044388|NCT00784134|141597961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.336|TWO_SIDED|95.0|0.7|2.89||Adjusted generalized ordered logit model odds ratios for eGOS scores of Moderate Disability or worse versus Good Recovery; Alteplase versus Saline|Generalized Ordered Logit Model|||||2.89|0.70|0.336
71044389|NCT00784134|141597961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.783|TWO_SIDED|95.0|0.57|1.52||Adjusted generalized ordered logit model odds ratios for eGOS scores of Upper Severe Disability or worse versus Moderate Disability + Good Recovery; Alteplase versus Saline|Generalized Ordered Logit Model|||||1.52|0.57|0.783
70925225|NCT03378570|141343634|OTHER|comparative effectiveness trial||||||0.852|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Anger-Hostility.||||.852
70925226|NCT03378570|141343634|OTHER|comparative effectiveness trial||||||0.083|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Anger-Physical Aggression.||||.083
70925227|NCT03378570|141343634|OTHER|comparative effectiveness trial||||||0.391|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Negative Affect.||||.391
70925228|NCT03378570|141343634|OTHER|comparative effectiveness trial||||||0.014|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Social Satisfaction.||||.014
70925229|NCT03378570|141343634|OTHER|comparative effectiveness trial||||||0.109|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Psychological Well Being.||||.109
70925230|NCT03378570|141343635|SUPERIORITY|||||||0.231||||||Week 6 timepoint p-value listed above|Mixed Models Analysis|"Other timepoint p-values below:~First Visit p = 0.875 Week 1 p = 0.084 Week 2 p = 0.277 Week 3 p = 0.686 Week 4 p = 0.369 Week 5 p = 0.806"||||||0.231
70925231|NCT03378570|141343636|SUPERIORITY|||||||0.963||||||Week 6-7 Follow-up p-value listed above|Mixed Models Analysis|"Other timepoint p-values below:~Evaluation p = 0.570 Week 2-3 Follow-up p = 0.063 Week 4-5 Follow-up p = 0.792"||||||0.963
70925232|NCT03378570|141343637|SUPERIORITY|||||||0.051||||||Week 6 timepoint p-value listed above|Mixed Models Analysis|"Other timepoint p-values below:~First Visit p = 0.772 Week 1 p = 0.194 Week 2 p = 0.127 Week 3 p = 0.196 Week 4 p = 0.079 Week 5 p = 0.187"||||||0.051
70925233|NCT04169373|141343656|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|26.4|||<|0.0001|TWO_SIDED|95.0|17.9|34.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (\> ULN vs ≤ ULN).|Response Rate Difference = Upadacitinib - Placebo|Efficacy analyses and hypothesis testing including multiplicity adjustment were performed independently for Study 1 and Study 2.||34.9|17.9|<0.0001
71044390|NCT00784134|141597962|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
71044391|NCT00784134|141597963|SUPERIORITY_OR_OTHER|||||||0.312|||||||t-test, 2 sided|||||||0.312
70925234|NCT04169373|141343657|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|22.2|||<|0.0001|TWO_SIDED|95.0|12.1|32.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP status.|Response Rate Difference = Upadacitinib - Placebo|"Efficacy analyses and hypothesis testing including multiplicity adjustment were performed independently for Study 1 and Study 2.~Binary endpoints in Study 2 were analyzed using the Cochran-Mantel-Haenszel (CMH) test stratified by the main stratification factor of positivity for MRI inflammation in the sacroiliac joints and screening hsCRP status (MRI-positive and hsCRP \> ULN vs MRI-positive and hsCRP ≤ ULN vs MRI-negative and hsCRP \> ULN)."||32.3|12.1|<0.0001
71044392|NCT00784134|141597964|SUPERIORITY_OR_OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.65
71044393|NCT00784134|141597965|SUPERIORITY_OR_OTHER|||||||0.478|||||||t-test, 2 sided|||||||0.478
71044394|NCT00784134|141597966|SUPERIORITY_OR_OTHER|||||||0.634|||||||t-test, 2 sided|||||||0.634
71044395|NCT00784134|141597967|SUPERIORITY_OR_OTHER|||||||0.255|||||||t-test, 2 sided|||||||0.255
71044396|NCT00784134|141597968|SUPERIORITY_OR_OTHER|||||||0.224|||||||t-test, 2 sided|||||||0.224
71101576|NCT00761137|141710963|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||ANOVA|||"Primary outcome was analyzed by a mixed-effects ANOVA model employing subject as a random factor as well as visit and treatment as fixed factors. Intention-to-treat (ITT) sample was analyzed. Unweighted means and their 95% Confidence Interval (CI) are reported, which represent treatment group means adjusted for the effect of visit and removing the intra-subject variability. For all analyses, significance level was set at 5%."||||0.6
71101577|NCT01197300|141710972|SUPERIORITY|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|3.7||||0.8505|TWO_SIDED|95.0|-37.242|44.642||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Lumbar Spine BMD Z-score Change at Month 18||44.642|-37.242|0.8505
71101578|NCT01197300|141710972|SUPERIORITY|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|21.752||||0.218|TWO_SIDED|95.0|-14.126|57.63||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Lumbar Spine BMD Z-score Change at Month 24||57.630|-14.126|0.2180
71101579|NCT01197300|141710973|SUPERIORITY|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|2.36||||0.3544|TWO_SIDED|95.0|-2.886|7.606||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Lumbar Spine BMC Change at Month 18||7.606|-2.886|0.3544
71101580|NCT01197300|141710973|SUPERIORITY|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|1.179||||0.705|TWO_SIDED|95.0|-5.281|7.639||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Lumbar Spine BMC Change at Month 24||7.639|-5.281|0.7050
71044397|NCT00784134|141597969|SUPERIORITY_OR_OTHER|||||||0.882|||||||t-test, 2 sided|||||||0.882
71044398|NCT00784134|141597970|SUPERIORITY_OR_OTHER|||||||0.551|||||||t-test, 2 sided|||||||0.551
71044399|NCT00784134|141597971|SUPERIORITY_OR_OTHER|||||||0.224|||||||t-test, 2 sided|||||||0.224
71044400|NCT00784134|141597972|SUPERIORITY_OR_OTHER|||||||0.376|||||||t-test, 2 sided|||||||0.376
71044401|NCT03694808|141597991|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|ratio of GMT (Fluzone/Fluad)|1.23|||||TWO_SIDED|95.0|0.8|1.89|||t-test, 2 sided|||Statistical Analysis for Year 1 (2018-2019)||1.89|0.8|
71044402|NCT03694808|141597991|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|0.95|||||TWO_SIDED|95.0|0.66|1.38|||t-test, 2 sided|||Statistical Analysis for Year 2 (2019-2020)||1.38|0.66|
71044403|NCT03694808|141597992|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|1.38|||||TWO_SIDED|95.0|0.88|2.15|||t-test, 2 sided|||Statistical Analysis for Year 1 (2018-2019)||2.15|0.88|
70925235|NCT04169373|141343657|OTHER||Odds Ratio (OR)|2.8|||||TWO_SIDED|95.0|1.7|4.5|||||Upadacitinib : Placebo|A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.||4.5|1.7|
71101581|NCT01197300|141710974|SUPERIORITY|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|121.129||||0.531|TWO_SIDED|95.0|-291.0|533.258||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Total body BMC Change at Month 18||533.258|-291.000|0.5310
71004999|NCT02903966|141517945|OTHER||Least Square Mean Difference|0.01|||||TWO_SIDED|95.0|-2.05|2.07|||||Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||2.07|-2.05|
71005000|NCT02903966|141517946|OTHER||Least Square Mean Difference|0.08|||||TWO_SIDED|95.0|-2.11|2.27|||||Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||2.27|-2.11|
70925236|NCT04169373|141343658|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Least Squares (LS) Mean Difference|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.85|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-0.85|-1.20|<0.0001
71044404|NCT03694808|141597992|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|0.86|||||TWO_SIDED|95.0|0.53|1.4|||t-test, 2 sided|||Statistical Analysis for Year 2 (2019-2020)||1.4|0.53|
71044405|NCT03694808|141597993|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|1.85|||||TWO_SIDED|95.0|1.23|2.79|||t-test, 2 sided|||Statistical Analysis Year 1 (2018-2019)||2.79|1.23|
71044406|NCT03694808|141597993|NON_INFERIORITY|2-sided t-test performed on log-transformed titers; estimate and 95% confidence interval of log-scale difference exponentiated to generate GMT ratio and its 95% CI below.|Ratio of GMT (Fluzone/Fluad)|0.88|||||TWO_SIDED|95.0|0.61|1.26|||t-test, 2 sided|||Statistical Analysis Year 2 (2019-2020)||1.26|0.61|
71044407|NCT03694808|141597994|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|0.154|||||TWO_SIDED|95.0|-0.001|0.308|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 1 (2018-2019)||0.308|-0.001|
71044408|NCT03694808|141597994|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|-0.056|||||TWO_SIDED|95.0|-0.2|0.089|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 2 (2019-2020)||0.089|-0.2|
71044409|NCT03694808|141597995|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|0.218|||||TWO_SIDED|95.0|0.063|0.373|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 1 (2018-2019)||0.373|0.063|
71044410|NCT03694808|141597995|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|-0.008|||||TWO_SIDED|95.0|-0.139|0.123|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 2 (2019-2020)||0.123|-0.139|
71044411|NCT03694808|141597996|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|0.136|||||TWO_SIDED|95.0|-0.019|0.291|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 1 (2018-2019)||0.291|-0.019|
71044412|NCT03694808|141597996|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|0.024|||||TWO_SIDED|95.0|-0.117|0.164|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 2 (2019-2020)||0.164|-0.117|
71044413|NCT03694808|141597997|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|0.43|||||TWO_SIDED|95.0|0.29|0.64|||t-test, 2 sided|||Statistical Analysis Year 1 (2018-2019)||0.64|0.29|
71005001|NCT02903966|141517947|OTHER||Least Square Mean Difference|-0.76|||||TWO_SIDED|95.0|-5.29|3.77|||||Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||3.77|-5.29|
71005002|NCT02903966|141517948|OTHER||Least Square Mean Difference|-0.8|||||TWO_SIDED|95.0|-5.68|4.08|||||Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||4.08|-5.68|
71005003|NCT02903966|141517953|OTHER||Least Square Mean Difference|-0.36|||||TWO_SIDED|95.0|-1.58|0.86|||||Day 15. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||0.86|-1.58|
71005004|NCT02903966|141517953|OTHER||Least Square Mean Difference|-0.1|||||TWO_SIDED|95.0|-1.29|1.08|||||Day 29. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||1.08|-1.29|
71005005|NCT02903966|141517953|OTHER||Least Square Mean Difference|-0.34|||||TWO_SIDED|95.0|-1.72|1.04|||||Day 43. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||1.04|-1.72|
71005006|NCT02903966|141517954|OTHER||Least Square Mean Difference|-0.06|||||TWO_SIDED|95.0|-1.87|1.75|||||Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||1.75|-1.87|
71005007|NCT03070119|141518031|SUPERIORITY||Least square (LS) geometric mean ratio|0.86|||||TWO_SIDED|95.0|0.69|1.08||||||Week 52 - The analysis was based on an analysis of covariance (ANCOVA) model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, and use of riluzole or edaravone. Multiple imputation (MI) including treatment group, use of riluzole or edaravone, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||1.08|0.69|
71005008|NCT03070119|141518031|SUPERIORITY||LS geometric mean ratio|0.91|||=|0.3711|TWO_SIDED|95.0|0.75|1.11|||ANCOVA|ANCOVA model using MI.||Week 104 - The analysis was based on an ANCOVA model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||1.11|0.75|=0.3711
71005009|NCT03070119|141518031|SUPERIORITY||LS geometric mean ratio|1.06|||=|0.6344|TWO_SIDED|95.0|0.84|1.34|||ANCOVA|ANCOVA model using MI.||Week 148 - The analysis was based on an ANCOVA model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||1.34|0.84|=0.6344
71005010|NCT03070119|141518032|SUPERIORITY||LS geometric mean ratio|0.8|||||TWO_SIDED|95.0|0.63|1.03||||||Week 52 - The analysis was based on an ANCOVA model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||1.03|0.63|
71005011|NCT03070119|141518032|SUPERIORITY||LS geometric mean ratio|0.83|||=|0.2306|TWO_SIDED|95.0|0.6|1.13|||ANCOVA|ANCOVA model using MI.||Week 104 - The analysis was based on an ANCOVA model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||1.13|0.60|=0.2306
71005012|NCT03070119|141518032|SUPERIORITY||LS geometric mean ratio|0.92|||=|0.673|TWO_SIDED|95.0|0.61|1.38|||ANCOVA|ANCOVA model using MI.||Week 148 - The analysis was based on an ANCOVA model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||1.38|0.61|=0.6730
71044414|NCT03694808|141597997|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|0.45|||||TWO_SIDED|95.0|0.29|0.69|||t-test, 2 sided|||Statistical Analysis Year 2 (2019-2020)||0.69|0.29|
71044415|NCT03694808|141597998|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|0.91|||||TWO_SIDED|95.0|0.71|1.16|||t-test, 2 sided|||Statistical Analysis Year 1 (2018-2019)||1.16|0.71|
71044416|NCT03694808|141597998|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|0.96|||||TWO_SIDED|95.0|0.69|1.33|||t-test, 2 sided|||Statistical Analysis Year 2 (2019-2020)||1.33|0.69|
71044417|NCT03694808|141597999|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|-0.544|||||TWO_SIDED|95.0|-0.674|-0.414|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 1 (2018-2019)||-0.414|-0.674|
71044418|NCT03694808|141597999|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|-0.168|||||TWO_SIDED|95.0|-0.311|-0.025|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 2 (2019-2020)||-0.025|-0.311|
71044419|NCT03694808|141598000|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|-0.104|||||TWO_SIDED|95.0|-0.221|0.013|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 1 (2018-2019)||0.013|-0.221|
71044420|NCT03694808|141598000|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference of proportions|-0.113|||||TWO_SIDED|95.0|-0.241|0.015|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 2 (2019-2020)||0.015|-0.241|
71101582|NCT01197300|141710974|SUPERIORITY|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|65.674||||0.7347|TWO_SIDED|95.0|-344.067|475.415||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Total body BMC Change at Month 24||475.415|-344.067|0.7347
71044421|NCT02631837|141598007|NON_INFERIORITY|Our hypothesis was that women would accept a higher conversion rate of 15% for vNOTESbased on a telephone interview of 10 women treated by total vaginal NOTES hysterectomy. Women were asked to choose among ﬁve cut-off rates (5, 10, 15, 20 or 25%). Most women indicated 15%. We would conclude non-inferiority when the upper limit of the one-sided 95% conﬁdence interval for the difference in the proportions of women between both comparisons would be below 15%.||||||0.0221||||||The Farrington-Manning test for non-inferiority was performed with 5% significance level and yielded P = 0.0221 in a sensitivity analysis assuming one conversion in the vNOTES and 0 conversions in the laparoscopy group.|Farrington-Manning|||||||0.0221
71044422|NCT02631837|141598008|SUPERIORITY||Risk Difference (RD)|-0.34||||0.007|TWO_SIDED|95.0|-0.56|-0.13|||Fisher Exact|||||-0.13|-0.56|0.007
71044423|NCT02631837|141598008|SUPERIORITY|||||||0.007|||||||Fisher Exact|||||||0.007
71044424|NCT02631837|141598010|SUPERIORITY||Mean Difference (Final Values)|-5.9||||0.006|TWO_SIDED|95.0|-10.0|-1.8|||Mann-Whitney U test|Two-sided test||||-1.8|-10|0.006
71044425|NCT02631837|141598011|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71044426|NCT02631837|141598012|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||> 0.05
71044427|NCT02631837|141598013|SUPERIORITY||Risk Difference (RD)|-0.29||||0.009|TWO_SIDED|95.0|-0.47|-0.1|||Fisher Exact|||||-0.10|-0.47|0.009
71044428|NCT02631837|141598014|SUPERIORITY|||||||0.106|||||||Fisher Exact|||||||0.106
71044429|NCT02631837|141598015|SUPERIORITY||Median Difference (Final Values)|-34.0|||<|0.01|TWO_SIDED|95.0|-46.0|-22.0|||Mann-Whitney U test|||||-22|-46|< 0.01
71044430|NCT02631837|141598016|SUPERIORITY|||||||0.7604||||||We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.|Arm by time interaction|||||||0.7604
71044431|NCT02631837|141598017|SUPERIORITY|||||||0.3071||||||We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.|Arm by time interaction|||||||0.3071
71044432|NCT02631837|141598018|SUPERIORITY|||||||0.4541||||||We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.|Arm by time interaction|||||||0.4541
71044433|NCT02631837|141598019|SUPERIORITY|||||||0.4514||||||We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.|Arm by time interaction|||||||0.4514
71044434|NCT02631837|141598020|SUPERIORITY|||||||0.3473||||||We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.|Arm by time interaction|||||||0.3473
71044435|NCT02631837|141598021|SUPERIORITY|We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.||||||0.3473||||||We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.|Arm by time interaction|||||||0.3473
71044436|NCT02631837|141598023|SUPERIORITY||Mean Difference (Final Values)|-555.8||||0.11|TWO_SIDED|95.0||36.0|||Mann-Whitney U test|||||36|-1,044|0.110
71101583|NCT01197300|141710975|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-147.68||||0.4143|TWO_SIDED|95.0|-394.41|99.049||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum P1NP Change at Month 18||99.049|-394.410|0.4143
71044437|NCT03346070|141598028|SUPERIORITY||Hazard Ratio (HR)|1.92||||0.0075|TWO_SIDED|95.0|1.18|3.1|||Log Rank||Cox regression model|||3.10|1.18|0.0075
71101584|NCT01197300|141710975|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-132.437||||0.1266|TWO_SIDED|95.0|-286.452|21.579||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum P1NP Change at Month 24||21.579|-286.452|0.1266
71044438|NCT03346070|141598028|SUPERIORITY||Hazard Ratio (HR)|25.9|||<|0.0001|TWO_SIDED|95.0|9.72|69.03|||Log Rank||Cox regression model|||69.03|9.72|<0.0001
71044439|NCT03346070|141598028|SUPERIORITY||Hazard Ratio (HR)|61.4|||<|0.0001|TWO_SIDED|95.0|14.13|266.77|||Log Rank||Cox regression model|||266.77|14.13|<0.0001
71044440|NCT03346070|141598028|SUPERIORITY||Hazard Ratio (HR)|2.38||||0.0005|TWO_SIDED|95.0|1.44|3.93|||Log Rank||Cox regression model|||3.93|1.44|0.0005
71044441|NCT03346070|141598028|SUPERIORITY||Hazard Ratio (HR)|2.13|||<|0.0001|TWO_SIDED|95.0|1.5|3.01|||Log Rank||Cox regression model|||3.01|1.50|<0.0001
71044442|NCT03346070|141598029|SUPERIORITY||Difference in percentage|2.3||||0.602|TWO_SIDED|95.0|-9.6|15.0|||Miettinen & Nurminen method|||||15.0|-9.6|0.602
71044443|NCT03346070|141598029|SUPERIORITY||Difference in percentage|0.2||||0.969|TWO_SIDED|95.0|-13.4|13.5|||Miettinen & Nurminen method|||||13.5|-13.4|0.969
71044444|NCT03346070|141598029|SUPERIORITY||Difference in percentage|2.6||||0.567|TWO_SIDED|95.0|-8.7|15.0|||Miettinen & Nurminen method|||||15.0|-8.7|0.567
71044445|NCT03346070|141598029|SUPERIORITY||Difference in percentage|2.6||||0.571|TWO_SIDED|95.0|-8.8|15.0|||Miettinen & Nurminen method|||||15.0|-8.8|0.571
71044446|NCT03346070|141598029|SUPERIORITY||Difference in percentage|-0.2||||0.95|TWO_SIDED|95.0|-11.6|10.9|||Miettinen & Nurminen method|||||10.9|-11.6|0.950
71044447|NCT03346070|141598029|SUPERIORITY||Difference in percentage|2.9||||0.528|TWO_SIDED|95.0|-8.4|15.9|||Miettinen & Nurminen method|||||15.9|-8.4|0.528
71044448|NCT03346070|141598029|SUPERIORITY||Difference in percentage|1.3||||0.709|TWO_SIDED|95.0|-6.8|9.6|||Miettinen & Nurminen method|||||9.6|-6.8|0.709
71044449|NCT03346070|141598030|SUPERIORITY||Difference in percentage|2.2||||0.738|TWO_SIDED|95.0|-12.3|17.4|||Miettinen & Nurminen method|||||17.4|-12.3|0.738
71044450|NCT03346070|141598030|SUPERIORITY||Difference in percentage|11.1||||0.077|TWO_SIDED|95.0|-1.7|26.3|||Miettinen & Nurminen method|||||26.3|-1.7|0.077
71044451|NCT03346070|141598030|SUPERIORITY||Difference in percentage|2.4||||0.717|TWO_SIDED|95.0|-12.0|16.4|||Miettinen & Nurminen method|||||16.4|-12.0|0.717
71044452|NCT03346070|141598030|SUPERIORITY||Difference in percentage|5.0||||0.486|TWO_SIDED|95.0|-9.9|19.7|||Miettinen & Nurminen method|||||19.7|-9.9|0.486
71044453|NCT03346070|141598030|SUPERIORITY||Difference in percentage|-1.2||||0.849|TWO_SIDED|95.0|-16.2|12.4|||Miettinen & Nurminen method|||||12.4|-16.2|0.849
71044454|NCT03346070|141598030|SUPERIORITY||Difference in percentage|-4.9||||0.339|TWO_SIDED|95.0|-18.2|6.7|||Miettinen & Nurminen method|||||6.7|-18.2|0.339
71044455|NCT03346070|141598030|SUPERIORITY||Difference in percentage|6.6||||0.149|TWO_SIDED|95.0|-2.6|16.8|||Miettinen & Nurminen method|||||16.8|-2.6|0.149
71044456|NCT03346070|141598031|SUPERIORITY||Difference in percentage|-2.7||||0.299|TWO_SIDED|95.0|-13.9|6.7|||Miettinen & Nurminen method|||||6.7|-13.9|0.299
71101585|NCT01197300|141710976|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-17.691||||0.2123|TWO_SIDED|95.0|-41.925|6.543||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||BSAP Change at Month 18||6.543|-41.925|0.2123
71101586|NCT01197300|141710976|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-3.662||||0.4852|TWO_SIDED|95.0|-21.479|14.155||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||BSAP Change at Month 24||14.155|-21.479|0.4852
71101587|NCT01197300|141710977|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-4.661||||0.9009|TWO_SIDED|95.0|-16.647|7.325||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum NTX Change at Month 18||7.325|-16.647|0.9009
71101588|NCT01197300|141710977|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-2.558||||0.9472|TWO_SIDED|95.0|-8.864|3.747||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum NTX Change at Month 24||3.747|-8.864|0.9472
71101589|NCT01197300|141710978|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-1.482||||0.46|TWO_SIDED|95.0|-3.805|0.841||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum TRAP-5b Change at Month 18||0.841|-3.805|0.4600
71101590|NCT01197300|141710978|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-0.41||||0.9236|TWO_SIDED|95.0|-2.423|1.603||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum TRAP-5b Change at Month 24||1.603|-2.423|0.9236
71101591|NCT01197300|141710979|OTHER|The number and percentage of patients with new vertebral fractures during the 12 month Extension period was presented by Core treatment group. Between-treatment differences were evaluated using Fisher's exact test.||||||1|||||||Fisher Exact|||New vertebral fractures at Month 12 Extension||||1.0000
71101592|NCT01197300|141710980|OTHER|The number and percentage of patients with new morphometric vertebral fractures during the 12 month extension period was presented by core treatment group. Between-treatment differences will be evaluated using Fisher's exact test.||||||1|||||||Fisher Exact|||New morphometric vertebral fractures at Month 12 Extension||||1.0000
71101593|NCT01197300|141710981|OTHER||Odds Ratio (OR)|4.73||||0.3971|TWO_SIDED|95.0|0.13|173.07||Presented by treatment group and evaluated using a logistic regression model with Core treatment, pooled centers, underlying condition treated with glucocorticoids and Core baseline pain score as explanatory variables.|Regression, Logistic|||Reduction in Pain at Month 15||173.07|0.13|0.3971
71044457|NCT03346070|141598031|SUPERIORITY||Difference in percentage|0.0|||>|0.999|TWO_SIDED|95.0|-9.9|9.4|||Miettinen & Nurminen method|||||9.4|-9.9|>0.999
71044458|NCT03346070|141598031|SUPERIORITY||Difference in percentage|-2.6||||0.326|TWO_SIDED|95.0|-13.7|7.0|||Miettinen & Nurminen method|||||7.0|-13.7|0.326
71044459|NCT03346070|141598031|SUPERIORITY||Difference in percentage|-2.5||||0.335|TWO_SIDED|95.0|-13.6|7.1|||Miettinen & Nurminen method|||||7.1|-13.6|0.335
71044460|NCT03346070|141598031|SUPERIORITY||Difference in percentage|0.3||||0.935|TWO_SIDED|95.0|-11.1|11.9|||Miettinen & Nurminen method|||||11.9|-11.1|0.935
71044461|NCT03346070|141598031|SUPERIORITY||Difference in percentage|-2.7||||0.326|TWO_SIDED|95.0|-13.8|7.3|||Miettinen & Nurminen method|||||7.3|-13.8|0.326
71044462|NCT03346070|141598031|SUPERIORITY||Difference in percentage|-1.4||||0.299|TWO_SIDED|95.0|-7.5|3.5|||Miettinen & Nurminen method|||||3.5|-7.5|0.299
71044463|NCT03346070|141598032|SUPERIORITY||Difference in percentage|0.1|||||TWO_SIDED|95.0|-12.7|13.1|||||Miettinen and Nurminen method|||13.1|-12.7|
71044464|NCT03346070|141598032|SUPERIORITY||Difference in percentage|-3.6|||||TWO_SIDED|95.0|-19.6|12.2|||||Miettinen and Nurminen method|||12.2|-19.6|
71044465|NCT03346070|141598032|SUPERIORITY||Difference in percentage|5.1|||||TWO_SIDED|95.0|-8.1|19.7|||||Miettinen and Nurminen method|||19.7|-8.1|
71044466|NCT03346070|141598032|SUPERIORITY||Difference in percentage|-2.6|||||TWO_SIDED|95.0|-18.0|13.1|||||Miettinen and Nurminen method|||13.1|-18.0|
71101594|NCT01197300|141710981|OTHER||Odds Ratio (OR)|0.01||||0.6046|TWO_SIDED|95.0|0.01|999.99||Presented by treatment group and evaluated using a logistic regression model with Core treatment, pooled centers, underlying condition treated with glucocorticoids and Core baseline pain score as explanatory variables.|Regression, Logistic|||Reduction in Pain at Month 18||999.99|0.01|0.6046
71101595|NCT01197300|141710981|OTHER||Odds Ratio (OR)|0.01||||0.6046|TWO_SIDED|95.0|0.01|999.99||Presented by treatment group and evaluated using a logistic regression model with Core treatment, pooled centers, underlying condition treated with glucocorticoids and Core baseline pain score as explanatory variables.|Regression, Logistic|||Reduction in Pain at Month 21||999.99|0.01|0.6046
71044467|NCT03346070|141598032|SUPERIORITY||Difference in percentage|4.4|||||TWO_SIDED|95.0|-9.6|19.2|||||Miettinen and Nurminen method|||19.2|-9.6|
71044468|NCT03346070|141598032|SUPERIORITY||Difference in percentage|2.2|||||TWO_SIDED|95.0|-12.5|17.0|||||Miettinen and Nurminen method|||17.0|-12.5|
71044469|NCT03346070|141598032|SUPERIORITY||Difference in percentage|-1.8|||||TWO_SIDED|95.0|-11.4|7.8|||||Miettinen and Nurminen method|||7.8|-11.4|
71044470|NCT03346070|141598033|SUPERIORITY||Difference in percentage|-2.6|||||TWO_SIDED|95.0|-15.2|9.1|||||Miettinen and Nurminen method|||9.1|-15.2|
71044471|NCT03346070|141598033|SUPERIORITY||Difference in percentage|-8.5|||||TWO_SIDED|95.0|-22.3|1.3|||||Miettinen and Nurminen method|||1.3|-22.3|
71044472|NCT03346070|141598033|SUPERIORITY||Difference in percentage|-5.3|||||TWO_SIDED|95.0|-18.8|6.8|||||Miettinen and Nurminen method|||6.8|-18.8|
71044473|NCT03346070|141598033|SUPERIORITY||Difference in percentage|-8.0|||||TWO_SIDED|95.0|-21.2|1.8|||||Miettinen and Nurminen method|||1.8|-21.2|
71044474|NCT03346070|141598033|SUPERIORITY||Difference in percentage|-2.9|||||TWO_SIDED|95.0|-17.0|10.5|||||Miettinen and Nurminen method|||10.5|-17.0|
71044475|NCT03346070|141598033|SUPERIORITY||Difference in percentage|0.5|||||TWO_SIDED|95.0|-14.0|15.5|||||Miettinen and Nurminen method|||15.5|-14.0|
71044476|NCT03346070|141598033|SUPERIORITY||Difference in percentage|-5.5|||||TWO_SIDED|95.0|-13.9|1.2|||||Miettinen and Nurminen method|||1.2|-13.9|
71044477|NCT03346070|141598034|SUPERIORITY||Difference in percentage|-2.4|||||TWO_SIDED|95.0|-13.4|7.3|||||Miettinen and Nurminen method|||7.3|-13.4|
71044478|NCT03346070|141598034|SUPERIORITY||Difference in percentage|-0.4|||||TWO_SIDED|95.0|-12.3|10.8|||||Miettinen and Nurminen method|||10.8|-12.3|
71044479|NCT03346070|141598034|SUPERIORITY||Difference in percentage|-2.6|||||TWO_SIDED|95.0|-13.7|7.0|||||Miettinen and Nurminen method|||7.0|-13.7|
71044480|NCT03346070|141598034|SUPERIORITY||Difference in percentage|0.2|||||TWO_SIDED|95.0|-11.2|11.7|||||Miettinen and Nurminen method|||11.7|-11.2|
71044481|NCT03346070|141598034|SUPERIORITY||Difference in percentage|-0.2|||||TWO_SIDED|95.0|-11.5|11.0|||||Miettinen and Nurminen method|||11.0|-11.5|
71044482|NCT03346070|141598034|SUPERIORITY||Difference in percentage|0.2|||||TWO_SIDED|95.0|-11.0|12.0|||||Miettinen and Nurminen method|||12.0|-11.0|
71044483|NCT03346070|141598035|SUPERIORITY||Difference in percentage|3.0|||||TWO_SIDED|95.0|-10.8|16.9|||||Miettinen and Nurminen method|||16.9|-10.8|
71044484|NCT03346070|141598035|SUPERIORITY||Difference in percentage|-76.1|||||TWO_SIDED|95.0|-87.2|-57.6|||||Miettinen and Nurminen method|||-57.6|-87.2|
71044485|NCT03346070|141598035|SUPERIORITY||Difference in percentage|-78.7|||||TWO_SIDED|95.0|-88.8|-61.1|||||Miettinen and Nurminen method|||-61.1|-88.8|
71044486|NCT03346070|141598035|SUPERIORITY||Difference in percentage|2.8|||||TWO_SIDED|95.0|-7.2|14.2|||||Miettinen and Nurminen method|||14.2|-7.2|
71044487|NCT03346070|141598035|SUPERIORITY||Difference in percentage|2.9|||||TWO_SIDED|95.0|-4.8|11.0|||||Miettinen and Nurminen method|||11.0|-4.8|
71101596|NCT01197300|141710981|OTHER||Odds Ratio (OR)|1.31||||0.875|TWO_SIDED|95.0|0.05|38.04||Presented by treatment group and evaluated using a logistic regression model with Core treatment, pooled centers, underlying condition treated with glucocorticoids and Core baseline pain score as explanatory variables.|Regression, Logistic|||Reduction in Pain at Month 24||38.04|0.05|0.8750
71044488|NCT03346070|141598036|SUPERIORITY||Ratio of geometric means|0.64|||||TWO_SIDED|95.0|0.48|0.86|||||Log transformation and t-distribution|||0.86|0.48|
71044489|NCT03346070|141598036|SUPERIORITY||Ratio of geometric means|0.09|||||TWO_SIDED|95.0|0.06|0.12|||||Log transformation and t-distribution|||0.12|0.06|
71044490|NCT03346070|141598036|SUPERIORITY||Ratio of geometric means|0.14|||||TWO_SIDED|95.0|0.1|0.19|||||Log transformation and t-distribution|||0.19|0.10|
71044491|NCT03346070|141598036|SUPERIORITY||Ratio of geometric means|0.54|||||TWO_SIDED|95.0|0.4|0.71|||||Log transformation and t-distribution|||0.71|0.40|
71044492|NCT03346070|141598036|SUPERIORITY||Ratio of geometric means|0.59|||||TWO_SIDED|95.0|0.48|0.72|||||Log transformation and t-distribution|||0.72|0.48|
71044493|NCT03346070|141598037|SUPERIORITY||Ratio of geometric means|0.63|||||TWO_SIDED|95.0|0.5|0.8|||||Log transformation and t-distribution|||0.80|0.50|
71044494|NCT03346070|141598037|SUPERIORITY||Ratio of geometric means|0.09|||||TWO_SIDED|95.0|0.07|0.13|||||Log transformation and t-distribution|||0.13|0.07|
71044495|NCT03346070|141598037|SUPERIORITY||Ratio of geometric means|0.15|||||TWO_SIDED|95.0|0.11|0.2|||||Log transformation and t-distribution|||0.20|0.11|
71044496|NCT03346070|141598037|SUPERIORITY||Ratio of geometric means|0.56|||||TWO_SIDED|95.0|0.44|0.72|||||Log transformation and t-distribution|||0.72|0.44|
71044497|NCT03346070|141598037|SUPERIORITY||Ratio of geometric means|0.6|||||TWO_SIDED|95.0|0.51|0.7|||||Log transformation and t-distribution|||0.70|0.51|
71044498|NCT03346070|141598038|SUPERIORITY||Ratio of geometric means|0.66|||||TWO_SIDED|95.0|0.54|0.81|||||Log transformation and t-distribution|||0.81|0.54|
71044499|NCT03346070|141598038|SUPERIORITY||Ratio of geometric means|0.13|||||TWO_SIDED|95.0|0.09|0.17|||||Log transformation and t-distribution|||0.17|0.09|
71044500|NCT03346070|141598038|SUPERIORITY||Ratio of geometric means|0.19|||||TWO_SIDED|95.0|0.14|0.27|||||Log transformation and t-distribution|||0.27|0.14|
71044501|NCT03346070|141598038|SUPERIORITY||Ratio of geometric means|0.66|||||TWO_SIDED|95.0|0.52|0.83|||||Log transformation and t-distribution|||0.83|0.52|
71044502|NCT03346070|141598038|SUPERIORITY||Ratio of geometric means|0.66|||||TWO_SIDED|95.0|0.57|0.77|||||Log transformation and t-distribution|||0.77|0.57|
71044503|NCT03660241|141598042|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|138.49|||||TWO_SIDED|90.0|93.74|204.61|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group.||204.61|93.74|
71044504|NCT03660241|141598042|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|99.11|||||TWO_SIDED|90.0|57.3|171.43|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||171.43|57.30|
71044505|NCT03660241|141598043|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|182.91|||||TWO_SIDED|90.0|117.09|285.71|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||285.71|117.09|
71044506|NCT03660241|141598043|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|121.32|||||TWO_SIDED|90.0|68.32|215.41|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||215.41|68.32|
71044507|NCT03660241|141598044|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|99.51|||||TWO_SIDED|90.0|59.8|165.57|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||165.57|59.80|
71044508|NCT03660241|141598044|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|167.79|||||TWO_SIDED|90.0|97.2|289.64|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||289.64|97.20|
71044509|NCT03660241|141598045|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|154.22|||||TWO_SIDED|90.0|105.11|226.26|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||226.26|105.11|
71044510|NCT03660241|141598045|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|287.06|||||TWO_SIDED|90.0|196.72|418.89|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||418.89|196.72|
71044511|NCT03660241|141598046|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|137.43|||||TWO_SIDED|90.0|106.82|176.81|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||176.81|106.82|
71044512|NCT03660241|141598046|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|177.92|||||TWO_SIDED|90.0|135.91|232.92|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||232.92|135.91|
71044513|NCT03660241|141598047|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|269.78|||||TWO_SIDED|90.0|196.61|370.18|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||370.18|196.61|
71044514|NCT03660241|141598047|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|571.43|||||TWO_SIDED|90.0|447.27|730.05|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||730.05|447.27|
70925237|NCT04169373|141343659|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-3.9|||<|0.0001|TWO_SIDED|95.0|-5.47|-2.33|||ANCOVA|ANCOVA model including treatment and screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-2.33|-5.47|<0.0001
70925238|NCT04169373|141343660|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|26.4|||<|0.0001|TWO_SIDED|95.0|18.0|34.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (\> ULN vs ≤ ULN).|Response Rate Difference = Upadacitinib - Placebo|||34.8|18.0|<0.0001
71044515|NCT03660241|141598052|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|133.87|||||TWO_SIDED|90.0|102.45|174.92|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||174.92|102.45|
71044516|NCT03660241|141598052|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|129.49|||||TWO_SIDED|90.0|92.86|180.57|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||180.57|92.86|
71044517|NCT03660241|141598053|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|210.2|||||TWO_SIDED|90.0|154.6|285.8|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||285.80|154.60|
71044518|NCT03660241|141598053|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|290.68|||||TWO_SIDED|90.0|217.39|388.69|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||388.69|217.39|
71101597|NCT01197300|141710982|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-0.01||||0.9231|TWO_SIDED|95.0|-0.18|0.17||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline bone age as explanatory variables and pooled centers as random effect.|ANCOVA|||2nd metacarpal cortical width chge from BL1 at Month 24||0.17|-0.18|0.9231
71101598|NCT01197300|141710982|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-0.11||||0.2694|TWO_SIDED|95.0|-0.32|0.1||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Extension baseline bone age as explanatory variables and pooled centers as random effect.|ANCOVA|||2nd metacarpal cortical width chge from BL2 at Month 24||0.10|-0.32|0.2694
71101599|NCT00834574|141710991|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.0||||||90.0|97.2|110.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||110|97.2|
71101600|NCT00834574|141710992|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|107.0||||||90.0|101.0|114.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||114|101|
71044519|NCT00934596|141598054|SUPERIORITY_OR_OTHER||Median Difference (Net)|57.0|||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.01
71044520|NCT00934596|141598057|SUPERIORITY_OR_OTHER||Median Difference (Net)|72.0|||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71044521|NCT00934596|141598062|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.0|||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||As data for these small groups were non-parametric the median and quartiles were used for comparison of groups by the Wilcoxon Rank Sum test.||||<0.001
71101601|NCT00834574|141710993|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|107.0||||||90.0|101.0|114.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||114|101|
71044522|NCT01221090|141598067|SUPERIORITY_OR_OTHER|||||||0.771||95.0||||A priori threshold for statistical significance is \<0.05|Likelihood Ratio Tests|||We used a multilevel statistical model including time (in days) as a continuous variable, where 0=baseline. The lowest level of the hierarchy was repeated measurements of HbA1c on each subject, with participants themselves constituting the 2nd level. Forward selection was utilized, in which powers of time were added one at a time to the base model including treatment group effects. Interaction terms between time \& treatment effects were added gradually and evaluated with likelihood ratio tests.||||0.771
71044523|NCT01221090|141598068|SUPERIORITY_OR_OTHER|||||||0.2176||95.0||||A priori threshold for statistical significance is \<0.05|Regression, Linear|Robust variance estimates.||||||0.2176
71044524|NCT01221090|141598069|SUPERIORITY_OR_OTHER|||||||0.572||95.0||||A priori threshold for statistical significance was \<0.05|Fisher Exact|||||||0.572
71044525|NCT01221090|141598070|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Test blood sugar."||||0.26
71044526|NCT01221090|141598070|SUPERIORITY_OR_OTHER|||||||0.21||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Test blood sugar the recommended times."||||0.21
71044527|NCT01221090|141598070|SUPERIORITY_OR_OTHER|||||||0.53||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Exercise at least 30 minutes."||||0.53
71044528|NCT01221090|141598070|SUPERIORITY_OR_OTHER|||||||0.24||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Participate in a specific exercise session."||||0.24
71044529|NCT01221090|141598070|SUPERIORITY_OR_OTHER|||||||0.18||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Check feet."||||0.18
71044530|NCT01221090|141598070|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Wash feet."||||0.19
71044531|NCT01221090|141598070|SUPERIORITY_OR_OTHER|||||||0.87||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Soak feet."||||0.87
70925239|NCT04169373|141343661|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|27.1|||<|0.0001|TWO_SIDED|95.0|17.9|36.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (\> ULN vs ≤ ULN).|Response Rate Difference = Upadacitinib - Placebo|||36.3|17.9|<0.0001
70925240|NCT04169373|141343662|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|10.9|||<|0.0001|TWO_SIDED|95.0|6.0|15.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (\> ULN vs ≤ ULN).|Response Rate Difference = Upadacitinib - Placebo|||15.8|6.0|<0.0001
71044532|NCT01221090|141598070|SUPERIORITY_OR_OTHER|||||||0.53||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Dry between toes."||||0.53
71044533|NCT01221090|141598070|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Inspect inside of shoes."||||0.32
71044534|NCT01221090|141598070|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Follow healthful eating plan."||||0.37
71044535|NCT01221090|141598070|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Space carbohydrates."||||0.72
71044536|NCT01221090|141598070|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Eat 5+ servings of fruits and vegetables."||||0.59
71044537|NCT01221090|141598070|SUPERIORITY_OR_OTHER||||||<|0.004||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Eat high-fat foods."||||<0.004
71044538|NCT01221090|141598070|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Eat packaged foods (e.g., sweets and desserts)."||||0.66
71044539|NCT01221090|141598070|SUPERIORITY_OR_OTHER|||||||0.68||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Followed a healthful eating plan."||||0.68
71044540|NCT01221090|141598071|SUPERIORITY_OR_OTHER|||||||0.685||95.0||||A priori threshold for statistical significance is \<0.05|Regression, Linear|Robust Variance Estimation.||"This analysis was to compare the quality of life measure, Number of days physical health was not good in the past 30 days at the 12 month follow-up visit."||||0.685
71044541|NCT01221090|141598071|SUPERIORITY_OR_OTHER|||||||0.997||95.0||||A priori threshold for statistical significance is \<0.05|Regression, Linear|Robust variance estimation.||"This analysis was to compare the quality of life measure, Number of days mental health was not good in the past 30 days at the 12 month follow-up visit."||||0.997
71044542|NCT01221090|141598071|SUPERIORITY_OR_OTHER|||||||0.3067||95.0||||A priori threshold for statistical significance is \<0.05|Regression, Linear|Robust variance estimation.||"This analysis was to compare the quality of life measure, Number of days poor physical/mental health prevented usual activity in the past 30 days at the 12 month follow-up visit."||||0.3067
71044543|NCT02597582|141598128|NON_INFERIORITY_OR_EQUIVALENCE|"A previous study found that the mean operation time was 165 minutes for patients undergoing LigaSure vessel sealing system-assisted total laryngectomy plus neck dissection and 195 minutes for those receiving conventional hemostasis.~With a difference in operative duration of 30 minutes between the two groups,9 the estimated sample size needed to demonstrate a two-sided significance level of 0.05 with 80% power should be at least 18 participants in each treatment arm."||||||0.022|||||||t-test, 2 sided|||||||0.022
71044544|NCT02597582|141598129|NON_INFERIORITY_OR_EQUIVALENCE|As above||||||0.266|||||||t-test, 2 sided|||||||0.266
71044545|NCT02597582|141598130|NON_INFERIORITY_OR_EQUIVALENCE|as above||||||0.06|||||||t-test, 2 sided|||||||0.060
71044546|NCT02597582|141598132|NON_INFERIORITY_OR_EQUIVALENCE|as above||||||0.524|||||||t-test, 2 sided|||||||0.524
71044547|NCT02597582|141598133|NON_INFERIORITY_OR_EQUIVALENCE|as above||||||0.037|||||||Wilcoxon (Mann-Whitney)|||||||0.037
71044548|NCT00440466|141598139|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a difference in the mean change in hemoglobin from baseline to the average of the last 12 weeks of treatment of -0.3 g/dL between QW and Q2W groups, a pooled standard deviation of 1.5 g/dL, and a noninferiority margin of 1 g/dL, a sample size of approximately 200 subjects (100 per group) would provide 90% power to demonstrate that Q2W group would not inferior to QW group for an overall 2-sided 0.05 significance level.|Difference of Least Squares Means|-0.03|STANDARD_ERROR_OF_MEAN|0.092|||TWO_SIDED|95.0|-0.208|0.153|||ANCOVA|||The null hypothesis was that the lower limit of the 95% confidence interval (CI) for the difference in mean change in hemoglobin from baseline to the average of the last 12 weeks of treatment between the every-2-weeks (Q2W) and once-weekly (QW) groups would be lower than -1 g/dL.||0.153|-0.208|
71044549|NCT00440466|141598139|NON_INFERIORITY_OR_EQUIVALENCE|Under the same assumptions in the sample size calculation for the QW and the Q2W, 100 subjects would be needed for the Q4W. However, because Study EPO-AKD-3001 and the current study both included QW and Q2W groups, the sample size would add up to 200 for each group if combined, the sample size in the Q4W group in the current study was increased to 200 subjects in order to enroll a comparable and sufficiently large number of subjects in each of the 3 extended dosing groups across the 2 studies.|Difference of Least Squares Means|-0.09|STANDARD_ERROR_OF_MEAN|0.079|||TWO_SIDED|95.0|-0.249|0.063|||ANCOVA|||The null hypothesis was that the lower limit of the 95% confidence interval (CI) for the difference in mean change in hemoglobin from baseline to the average of the last 12 weeks of treatment between the every-4-weeks (Q4W) and once-weekly (QW) groups would be lower than -1 g/dL.||0.063|-0.249|
71044550|NCT00440466|141598141|SUPERIORITY_OR_OTHER||Difference in percentage of participants|10.9|||||TWO_SIDED|95.0|0.1|21.7|||95% Confidence Interval|||||21.7|0.1|
71044551|NCT00440466|141598141|SUPERIORITY_OR_OTHER||Difference in percentage of participants|1.1|||||TWO_SIDED|95.0|-9.1|11.2|||95% of Confidence Interval|||||11.2|-9.1|
71044552|NCT00440466|141598142|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.13|||||TWO_SIDED|95.0|-0.113|0.372|||ANOVA|||||0.372|-0.113|
71044553|NCT00440466|141598142|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.11|||||TWO_SIDED|95.0|-0.098|0.32|||ANOVA|||||0.320|-0.098|
71044554|NCT00440466|141598143|SUPERIORITY_OR_OTHER||Difference in percentage of participants|8.2|||||TWO_SIDED|95.0|-2.0|18.3|||95% of Confidence Interval|||||18.3|-2.0|
71044555|NCT00440466|141598143|SUPERIORITY_OR_OTHER||Difference in percentage of participants|10.3||||||95.0|1.5|19.2|||95% of Confidence Interval|||||19.2|1.5|
71044556|NCT00440466|141598144|SUPERIORITY_OR_OTHER||Difference in percentage of participants|5.7|||||TWO_SIDED|95.0|-7.7|19.1|||95% of Confidence Interval|||||19.1|-7.7|
71044557|NCT00440466|141598144|SUPERIORITY_OR_OTHER||Difference in percentage of participants|9.1|||||TWO_SIDED|95.0|-2.5|20.6|||95% of Confidence Interval|||||20.6|-2.5|
71044558|NCT00440466|141598145|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-3.2|||||TWO_SIDED|95.0|-15.8|9.5|||95% of Confidence Interval|||||9.5|-15.8|
71044559|NCT00440466|141598145|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-3.0|||||TWO_SIDED|95.0|-13.9|8.0|||95% of Confidence Interval|||||8.0|-13.9|
71044560|NCT00440466|141598146|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.08||||||95.0|-0.367|0.208|||ANOVA|||||0.208|-0.367|
71044561|NCT00440466|141598146|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.04|||||TWO_SIDED|95.0|-0.206|0.289|||ANOVA|||||0.289|-0.206|
71044562|NCT00418522|141598148|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority test utilized a one-sided 2.5% level of significance.|Mean Difference (Final Values)|-0.19|||<|0.0001||95.0|-0.38|0.0|||ANCOVA||A confidence interval (CI) approach was presented with a two-sided 95% CI of the difference between treatment and control.|The null hypothesis was that the inhaled human insulin group was inferior to the insulin glargine group with respect to 26-week change from baseline in HbA1c, while the alternate hypothesis is that the inhaled human insulin group was not inferior to the insulin glargine group with respect to 26-week change from baseline in HbA1c, given the predetermined non-inferiority margin of 0.4%.||0|-0.38|<0.0001
71044563|NCT00418522|141598148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.0516||95.0|-0.38|0.0|||ANCOVA||The superiority test used a one-sided 2.5% level of significance.|With an established non-inferiority claim, an additional test for superiority was conducted (ie, the margin was 0.0%).||0|-0.38|0.0516
71044564|NCT00418522|141598149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96||||0.0052||95.0|1.22|3.14|||Regression, Logistic|||||3.14|1.22|0.0052
71044565|NCT00418522|141598150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01||||0.0022||95.0|1.29|3.15|||Regression, Logistic|||||3.15|1.29|0.0022
71044566|NCT00418522|141598151|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.248||95.0|0.4|1.27|||Regression, Logistic|||||1.27|0.40|0.2480
71044567|NCT00418522|141598152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.57||||0.6091||95.0|-7.31|12.46|||ANCOVA|||||12.46|-7.31|0.6091
71044568|NCT00418522|141598153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.96|||<|0.0001||95.0|22.66|43.25|||ANCOVA|||Time 0 (fasting) at Week 26.||43.25|22.66|<0.0001
71044569|NCT00418522|141598153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.57|||<|0.0001||95.0|16.55|40.59|||ANCOVA|||Time 30 at Week 26.||40.59|16.55|<0.0001
71044570|NCT00418522|141598153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.96||||0.0044||95.0|5.96|31.96|||ANCOVA|||Time 60 at Week 26.||31.96|5.96|0.0044
71044571|NCT00418522|141598153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.69||||0.3168||95.0|-6.45|19.83|||ANCOVA|||Time 90 at Week 26.||19.83|-6.45|0.3168
71044572|NCT00418522|141598153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.9222||95.0|-12.12|13.39|||ANCOVA|||Time 120 at Week 26.||13.39|-12.12|0.9222
71044573|NCT00418522|141598153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.41||||0.695||95.0|-14.51|9.69|||ANCOVA|||Time 180 at Week 26.||9.69|-14.51|0.6950
71044574|NCT00418522|141598154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.61||||0.1207||95.0|-21.76|2.54|||ANCOVA|||Post-Breakfast, Week 26.||2.54|-21.76|0.1207
71044575|NCT00418522|141598154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.11|||<|0.0001||95.0|-39.77|-18.44|||ANCOVA|||Post-Lunch, Week 26.||-18.44|-39.77|<0.0001
71044576|NCT00418522|141598154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.76|||<|0.0001||95.0|-44.17|-23.35|||ANCOVA|||Post-Dinner, Week 26.||-23.35|-44.17|<0.0001
71044577|NCT00418522|141598155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.21||||0.0735||95.0|-0.5|10.91|||ANCOVA|||Total Cholesterol at Week 26.||10.91|-0.50|0.0735
71044578|NCT00418522|141598155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.09||||0.0017||95.0|0.79|3.39|||ANCOVA|||HDL-c at Week 26.||3.39|0.79|0.0017
71044579|NCT00418522|141598155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.43||||0.1369||95.0|-1.1|7.96|||ANCOVA|||LDL-c at Week 26.||7.96|-1.10|0.1369
71005013|NCT03070119|141518033|SUPERIORITY||Least square (LS) mean difference|3.6|STANDARD_ERROR_OF_MEAN|1.58|||TWO_SIDED|95.0|0.5|6.7||||||Week 52 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline ALSFRS-R total score, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||6.7|0.5|
71005014|NCT03070119|141518033|SUPERIORITY||LS mean difference|3.7|STANDARD_ERROR_OF_MEAN|2.28|=|0.1054|TWO_SIDED|95.0|-0.8|8.2|||ANCOVA|ANCOVA model using MI.||Week 104 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline ALSFRS-R total score, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||8.2|-0.8|=0.1054
71005015|NCT03070119|141518033|SUPERIORITY||LS mean difference|3.6|STANDARD_ERROR_OF_MEAN|2.46|=|0.1432|TWO_SIDED|95.0|-1.2|8.4|||ANCOVA|ANCOVA model using MI.||Week 148 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline ALSFRS-R total score, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||8.4|-1.2|=0.1432
71044580|NCT00418522|141598155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.26||||0.5684||95.0|-10.4|18.92|||ANCOVA|||Triglycerides at Week 26.||18.92|-10.40|0.5684
71044581|NCT00418522|141598156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.5673||95.0|-0.58|1.06|||ANCOVA|||hs-CRP at Week 26.||1.06|-0.58|0.5673
71044582|NCT00418522|141598156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.6099||95.0|-2.97|1.75|||ANCOVA|||Leptin at Week 26.||1.75|-2.97|0.6099
71044583|NCT00418522|141598156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.28||||0.7684||95.0|-12.94|17.51|||ANCOVA|||Spot urine microalbumin at Week 26.||17.51|-12.94|0.7684
71044584|NCT00418522|141598157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.36||||0.5005||95.0|-0.69|1.42|||ANCOVA|||Adiponectin at Week 26.||1.42|-0.69|0.5005
71044585|NCT00418522|141598157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.685||95.0|-0.03|0.04|||ANCOVA|||ApoB at Week 26.||0.04|-0.03|0.6850
71005016|NCT03070119|141518034|SUPERIORITY||LS mean difference|8.1|STANDARD_ERROR_OF_MEAN|3.99|||TWO_SIDED|95.0|0.3|15.9||||||Week 52 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline percent predicted SVC and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||15.9|0.3|
71005017|NCT03070119|141518034|SUPERIORITY||LS mean difference|9.3|STANDARD_ERROR_OF_MEAN|5.6|=|0.0963|TWO_SIDED|95.0|-1.7|20.4|||ANCOVA|ANCOVA model using MI.||Week 104 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline percent predicted SVC and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||20.4|-1.7|=0.0963
70925241|NCT04169373|141343663|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.53|||<|0.0001|TWO_SIDED|95.0|-1.96|-1.11|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-1.11|-1.96|<0.0001
71044586|NCT00418522|141598158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|58.7||||0.1856||95.0|-43.37|160.77|||ANCOVA|||||160.77|-43.37|0.1856
71044587|NCT00418522|141598159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.72||||0.1862||95.0|-51.34|13.89|||ANCOVA|||||13.89|-51.34|0.1862
71044588|NCT00418522|141598165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.0055||95.0|0.35|2.04|||ANCOVA|||||2.04|0.35|0.0055
71044589|NCT00418522|141598166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.0053||95.0|0.12|0.71|||ANCOVA|||||0.71|0.12|0.0053
71044590|NCT00418522|141598168|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority test utilized a one-sided 2.5% level of significance.|Mean Difference (Final Values)|-0.27|||<|0.0001||95.0|-0.47|-0.08|||ANCOVA||A CI approach was presented with a two-sided 95% CI of the difference between treatment and control.|The null hypothesis was that the inhaled human insulin group was inferior to the insulin glargine group with respect to 26-week change from baseline in HbA1c, while the alternate hypothesis is that the inhaled human insulin group was not inferior to the insulin glargine group with respect to 26-week change from baseline in HbA1c, given the predetermined non-inferiority margin of 0.4%.||-0.08|-0.47|<0.0001
71044591|NCT00418522|141598168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.0062||95.0|-0.47|-0.08|||ANCOVA||The superiority test used a one-sided 2.5% level of significance.|With an established non-inferiority claim, an additional test for superiority was conducted (ie, the margin was 0.0%).||-0.08|-0.47|0.0062
71044592|NCT01612884|141598180|OTHER|Student's T-test||||||0.85|||||||t-test, 2 sided|||||||0.85
71044593|NCT01612884|141598181|OTHER|Chi-Square||||||0.93|||||||Chi-squared|||||||0.93
71044594|NCT01612884|141598182|OTHER|Chi-Square|||||>|0.05|||||||Chi-squared|||||||>0.05
71044595|NCT02790034|141598189|SUPERIORITY||Mean Difference (Final Values)|-5.292|STANDARD_ERROR_OF_MEAN|11.3184||0.6411|TWO_SIDED|95.0|-27.741|17.157|||Mixed Models Analysis|||Primary inferential comparison between treatment groups used a restricted maximum likelihood (REML)-based, mixed-effects repeated measures model approach (MMRM) with 95% CI for the difference between treatment groups for % change from baseline in the number of apnea episodes. Model included % change from baseline as response, the fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, and the continuous terms age and baseline value as covariate.||17.157|-27.741|0.6411
71044596|NCT02790034|141598189|SUPERIORITY||Mean Difference (Final Values)|-16.966|STANDARD_ERROR_OF_MEAN|13.1869||0.2011|TWO_SIDED|95.0|-43.119|9.186|||Mixed Models Analysis|||Primary inferential comparison between treatment groups used a restricted maximum likelihood (REML)-based, mixed-effects repeated measures model approach (MMRM) with 95% CI for the difference between treatment groups for % change from baseline in the number of apnea episodes. Model included % change from baseline as response, the fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, and the continuous terms age and baseline value as covariate.||9.186|-43.119|0.2011
71044597|NCT03440424|141598191|OTHER||Percent ratio of geometric mean|157.86|||||TWO_SIDED|90.0|118.18|210.87|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||210.87|118.18|
71044598|NCT03440424|141598191|OTHER||Percent ratio of geometric mean|122.2|||||TWO_SIDED|90.0|91.49|163.24|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||163.24|91.49|
71044599|NCT03440424|141598192|OTHER||Percent ratio of geometric mean|122.31|||||TWO_SIDED|90.0|98.95|151.17|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||151.17|98.95|
71044600|NCT03440424|141598192|OTHER||Percent ratio of geometric mean|103.24|||||TWO_SIDED|90.0|83.53|127.61|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||127.61|83.53|
71044601|NCT03440424|141598193|OTHER||Percent ratio of geometric mean|125.26|||||TWO_SIDED|90.0|96.76|162.16|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||162.16|96.76|
71044602|NCT03440424|141598193|OTHER||Percent ratio of geometric mean|115.2|||||TWO_SIDED|90.0|88.98|149.13|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||149.13|88.98|
71044603|NCT03440424|141598194|OTHER||Percent ratio of geometric mean|131.91|||||TWO_SIDED|90.0|96.46|180.4|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||180.40|96.46|
71044604|NCT03440424|141598194|OTHER||Percent ratio of geometric mean|149.52|||||TWO_SIDED|90.0|109.34|204.47|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||204.47|109.34|
71044605|NCT03440424|141598195|OTHER||Percent ratio of geometric mean|125.03|||||TWO_SIDED|90.0|87.96|177.74|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||177.74|87.96|
71044606|NCT03440424|141598195|OTHER||Percent ratio of geometric mean|153.56|||||TWO_SIDED|90.0|106.39|221.66|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||221.66|106.39|
71044607|NCT03440424|141598196|OTHER||Percent ratio of geometric mean|128.88|||||TWO_SIDED|90.0|88.35|188.02|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||188.02|88.35|
71044608|NCT03440424|141598196|OTHER||Percent ratio of geometric mean|166.55|||||TWO_SIDED|90.0|112.31|246.99|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||246.99|112.31|
71044609|NCT03440424|141598197|OTHER||Percent ratio of geometric mean|96.97|||||TWO_SIDED|90.0|70.15|134.06|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||134.06|70.15|
71044610|NCT03440424|141598197|OTHER||Percent ratio of geometric mean|72.05|||||TWO_SIDED|90.0|52.12|99.6|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||99.60|52.12|
71044611|NCT03440424|141598197|OTHER||Percent ratio of geometric mean|84.36|||||TWO_SIDED|90.0|60.21|118.19|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||118.19|60.21|
71044612|NCT03440424|141598197|OTHER||Percent ratio of geometric mean|65.7|||||TWO_SIDED|90.0|46.89|92.05|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||92.05|46.89|
71044613|NCT03440424|141598197|OTHER||Percent ratio of geometric mean|94.74|||||TWO_SIDED|90.0|68.37|131.3|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||131.30|68.37|
71044614|NCT03440424|141598197|OTHER||Percent ratio of geometric mean|76.56|||||TWO_SIDED|90.0|55.24|106.09|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||106.09|55.24|
71044615|NCT03440424|141598199|OTHER||Percent ratio of geometric mean|99.14|||||TWO_SIDED|90.0|76.91|127.81|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||127.81|76.91|
71044616|NCT03440424|141598199|OTHER||Percent ratio of geometric mean|69.66|||||TWO_SIDED|90.0|54.03|89.79|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||89.79|54.03|
71044617|NCT03440424|141598199|OTHER||Percent ratio of geometric mean|78.98|||||TWO_SIDED|90.0|62.88|99.21|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||99.21|62.88|
71044618|NCT03440424|141598199|OTHER||Percent ratio of geometric mean|63.2|||||TWO_SIDED|90.0|50.31|79.38|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||79.38|50.31|
71044619|NCT03440424|141598199|OTHER||Percent ratio of geometric mean|94.56|||||TWO_SIDED|90.0|68.5|130.51|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||130.51|68.50|
71044620|NCT03440424|141598199|OTHER||Percent ratio of geometric mean|71.81|||||TWO_SIDED|90.0|52.03|99.12|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||99.12|52.03|
71044621|NCT03440424|141598200|OTHER||Percent ratio of geometric mean|106.7|||||TWO_SIDED|90.0|83.95|135.62|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||135.62|83.95|
71044622|NCT03440424|141598200|OTHER||Percent ratio of geometric mean|85.68|||||TWO_SIDED|90.0|67.41|108.9|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||108.90|67.41|
71044623|NCT03440424|141598200|OTHER||Percent ratio of geometric mean|75.41|||||TWO_SIDED|90.0|62.28|91.31|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||91.31|62.28|
71044624|NCT03440424|141598200|OTHER||Percent ratio of geometric mean|76.0|||||TWO_SIDED|90.0|62.76|92.02|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||92.02|62.76|
71101602|NCT00530257|141711042|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||We used a Bonferroni correct to adjust for up to 5 measures across domains and use a p-value of \<=0.01. With a sample of 30 subjects the analytic model was able to detect a difference of large effect size (Cohen's d= \>0.655)|Wilcoxon (Mann-Whitney)|||We evaluated the data for cross over effects. No statistical significant sequence effect were seen for our endpoints and hence we combined the data from both periods of the crossover design There was evidence against the assumption of normality for performance on some of the measures of attention. Thus we used the non-parametric Wilcoxon Signed Ranks Test to compare performance on OROS-methylphenidate versus placebo.||||<0.01
71101603|NCT00530257|141711043|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Same as described for TEA-Ch Walk, Don't Walk|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch Walk, Don't Walk||||<0.01
71044625|NCT03440424|141598200|OTHER||Percent ratio of geometric mean|95.55|||||TWO_SIDED|90.0|71.92|126.94|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||126.94|71.92|
71044626|NCT03440424|141598200|OTHER||Percent ratio of geometric mean|74.48|||||TWO_SIDED|90.0|56.06|98.94|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||98.94|56.06|
71044627|NCT03440424|141598201|OTHER||Percent ratio of geometric mean|113.04|||||TWO_SIDED|90.0|85.16|150.05|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||150.05|85.16|
71044628|NCT03440424|141598201|OTHER||Percent ratio of geometric mean|103.74|||||TWO_SIDED|90.0|78.16|137.7|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||137.70|78.16|
71044629|NCT03440424|141598201|OTHER||Percent ratio of geometric mean|78.62|||||TWO_SIDED|90.0|62.57|98.78|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||98.78|62.57|
71044630|NCT03440424|141598201|OTHER||Percent ratio of geometric mean|101.0|||||TWO_SIDED|90.0|80.38|126.9|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||126.90|80.38|
71044631|NCT03440424|141598201|OTHER||Percent ratio of geometric mean|109.49|||||TWO_SIDED|90.0|81.07|147.88|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||147.88|81.07|
71044632|NCT03440424|141598201|OTHER||Percent ratio of geometric mean|105.2|||||TWO_SIDED|90.0|77.89|142.08|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||142.08|77.89|
71044633|NCT03440424|141598202|OTHER||Percent ratio of geometric mean|115.38|||||TWO_SIDED|90.0|83.51|159.42|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||159.42|83.51|
71044634|NCT03440424|141598202|OTHER||Percent ratio of geometric mean|116.97|||||TWO_SIDED|90.0|84.66|161.62|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||161.62|84.66|
71044635|NCT03440424|141598202|OTHER||Percent ratio of geometric mean|78.46|||||TWO_SIDED|90.0|61.06|100.81|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||100.81|61.06|
71044636|NCT03440424|141598202|OTHER||Percent ratio of geometric mean|116.76|||||TWO_SIDED|90.0|89.95|151.56|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||151.56|89.95|
71044637|NCT03440424|141598202|OTHER||Percent ratio of geometric mean|94.97|||||TWO_SIDED|90.0|70.31|128.28|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||128.28|70.31|
71044638|NCT03440424|141598202|OTHER||Percent ratio of geometric mean|103.59|||||TWO_SIDED|90.0|75.43|142.28|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||142.28|75.43|
71044639|NCT01138826|141598211|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUC\[0- ∞\] of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|105.57|||||TWO_SIDED|90.0|98.09|113.61||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1036 on the natural log scale for AUCinf with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1234 for loge AUCinf.||113.61|98.09|
71044640|NCT01138826|141598211|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUC\[0- ∞\] of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|107.55|||||TWO_SIDED|90.0|99.98|115.69||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1036 on the natural log scale for AUCinf with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1234 for loge AUCinf.||115.69|99.98|
71005018|NCT03070119|141518034|SUPERIORITY||LS mean difference|4.3|STANDARD_ERROR_OF_MEAN|5.56|=|0.4388|TWO_SIDED|95.0|-6.6|15.2|||ANCOVA|ANCOVA model using MI.||Week 148 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline percent predicted SVC and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||15.2|-6.6|= 0.4388
71005019|NCT03070119|141518035|SUPERIORITY||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.109|||TWO_SIDED|95.0|0.051|0.477||||||Week 52 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline HHD overall megascore and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||0.477|0.051|
71005020|NCT03070119|141518035|SUPERIORITY||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.145|=|0.3207|TWO_SIDED|95.0|-0.141|0.43|||ANCOVA|ANCOVA model using MI.||Week 104 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline HHD overall megascore and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||0.430|-0.141|=0.3207
70925242|NCT04169373|141343664|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.69|||<|0.0001|TWO_SIDED|95.0|-2.14|-1.24|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-1.24|-2.14|<0.0001
70925243|NCT04169373|141343665|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|34.0|||<|0.0001|TWO_SIDED|95.0|26.2|41.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (\> ULN vs ≤ ULN).|Response Rate Difference = Upadacitinib - Placebo|||41.8|26.2|<0.0001
70925244|NCT04169373|141343666|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.17|||<|0.0001|TWO_SIDED|95.0|-1.55|-0.8|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-0.80|-1.55|<0.0001
70925245|NCT04169373|141343667|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|13.2|||<|0.0001|TWO_SIDED|95.0|7.4|19.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (\> ULN vs ≤ ULN).|Response Rate Difference = Upadacitinib - Placebo|||19.0|7.4|<0.0001
70925246|NCT04169373|141343668|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-3.07|||<|0.0001|TWO_SIDED|95.0|-3.9|-2.24|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-2.24|-3.90|<0.0001
70925247|NCT04169373|141343669|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.85|||<|0.0001|TWO_SIDED|95.0|-2.47|-1.24|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-1.24|-2.47|<0.0001
71005021|NCT03070119|141518035|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.091|=|0.5452|TWO_SIDED|95.0|-0.124|0.234|||ANCOVA|ANCOVA model using MI.||Week 148 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline HHD overall megascore and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||0.234|-0.124|=0.5452
71005022|NCT03070119|141518037|SUPERIORITY||Hazard Ratio (HR)|0.64|||=|0.4202|TWO_SIDED|95.0|0.282|1.461|||Log Rank|The analysis was based on a log rank test stratified by median baseline plasma NfL.|The analysis was based on a Cox proportional hazards model adjusted for baseline plasma NfL, and riluzole or edaravone use.|||1.461|0.282|=0.4202
71005023|NCT03070119|141518038|SUPERIORITY||Hazard Ratio (HR)|0.52|||=|0.3108|TWO_SIDED|95.0|0.199|1.357|||Log Rank|The analysis was based on a log rank test stratified by median baseline plasma NfL.|The analysis was based on a Cox proportional hazards model adjusted for baseline plasma NfL, and riluzole or edaravone use.|||1.357|0.199|=0.3108
71005024|NCT00732472|141518042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.26|STANDARD_ERROR_OF_MEAN|2.777|||TWO_SIDED|95.0|-3.39|7.91|||||Day 1, Max HR|||7.91|-3.39|
71005025|NCT00732472|141518042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|2.922|||TWO_SIDED|95.0|-4.78|7.28|||||Day 7, Max HR|||7.28|-4.78|
71044641|NCT01138826|141598211|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUC\[0- ∞\] of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|101.88|||||TWO_SIDED|90.0|94.7|109.6||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1036 on the natural log scale for AUCinf with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1234 for loge AUCinf.||109.60|94.70|
71101604|NCT00530257|141711044|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||This p value is not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||We evaluated the data for cross over effects. No statistical significant sequence effect were seen for our endpoints and hence we combined the data from both periods of the crossover design There was evidence against the assumption of normality for performance on some of the measures of attention. Thus we used the non-parametric Wilcoxon Signed Ranks Test to compare performance on OROS-methylphenidate versus placebo.||||<0.05
71101605|NCT00530257|141711046|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||We did not correct for multiple comparisons|t-test, 2 sided|We used a paired t-test||A paired t-test was used to compare the medication versus placebo.||||<0.05
71101606|NCT00530257|141711048|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Same as described for TEA-Ch: Walk, Don't Walk.|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch: Walk, Don't Walk||||<0.01
71101607|NCT00530257|141711049|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||The p value adjusts for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||<0.01
71101608|NCT00530257|141711050|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Same as described for TEA-Ch: Walk, Don't Walk|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch: Walk, Don't Walk||||<0.01
71101609|NCT00530257|141711051|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Same as described for TEA-Ch: Walk, Don't Walk|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch: Walk, Don't Walk||||<0.01
71101610|NCT00530257|141711052|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Same as described for TEA-Ch: Walk, Don't Walk|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch: Walk, Don't Walk||||<0.01
71101611|NCT00530257|141711053|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Same as described for TEA-Ch: Walk, Don't Walk|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch: Walk, Don't Walk||||<0.01
71101612|NCT01879826|141711099|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|With a power of 0.8 and an acceptable type I error size of 0.05, 38 patients per group was estimated to achieve significance||||||0.044|||||||t-test, 2 sided|||||||0.044
71101613|NCT01879826|141711100|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|With a power of 0.8 and an acceptable type I error size of 0.05, 38 patients per group was estimated to achieve significance.||||||0.04|||||||t-test, 2 sided|||||||0.04
71101614|NCT00839930|141711105|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be performed on the log-transformed AUC0-t, AUC0-inf and Cmax parameters.|Geometric Test/Ref Ratio x 100|93.39||||||90.0|87.33|99.86|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.86|87.33|
70925248|NCT04169373|141343670|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-0.32|||<|0.0001|TWO_SIDED|95.0|-0.46|-0.18|||ANCOVA|ANCOVA model including treatment and screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-0.18|-0.46|<0.0001
71005026|NCT00732472|141518042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.27|STANDARD_ERROR_OF_MEAN|2.772|||TWO_SIDED|95.0|-2.37|8.91|||||Day 1, Max HR|||8.91|-2.37|
71101615|NCT00839930|141711106|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be performed on the log-transformed AUC0-t, AUC0-inf and Cmax parameters.|Geometric Test/Ref Ratio x 100|96.14||||||90.0|91.04|101.52|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.52|91.04|
71101616|NCT00839930|141711107|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax parameters.|Geometric Test/Ref Ratio x 100|96.64||||||90.0|92.13|101.37|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.37|92.13|
71101617|NCT02500836|141711108|SUPERIORITY||||||<|0.0001||||||One-sided p-value|Fisher Exact|||The null hypothesis is that the proportions of treatment group successes are equal.||||<0.0001
71101618|NCT02500836|141711109|SUPERIORITY||||||<|0.0001||||||One-sided p-value|Fisher Exact|||The null hypothesis is that the proportions of treatment group successes are equal.||||<0.0001
71101619|NCT02003898|141711117|NON_INFERIORITY|non-inferiority test with an A1C margin of 0.4% and a significance level of 0.025 (one-sided).|Mean Difference (Net)|0.034|||||TWO_SIDED|95.0|-0.03|0.098||||||||0.098|-0.03|
71101620|NCT02272985|141711121|OTHER||||||=|0.03||||||the p value was calculated|Mixed Models Analysis|||||||=0.03
71101621|NCT02272985|141711122|OTHER|||||||0.001|||||||Mixed Models Analysis|||Left frontal gray matter:||||0.001
71101622|NCT02272985|141711122|OTHER|||||||0.08|||||||Mixed Models Analysis|||Right frontal gray matter:||||0.08
71101623|NCT04250207|141711171|SUPERIORITY|||||||0.0065|||||||Other (Wilcoxon Rank Sum Test)|||||||0.0065
71101624|NCT04250207|141711171|SUPERIORITY|||||||0.0344|||||||Other (Wilcoxon Rank Sum Test)|||||||0.0344
71101625|NCT04250207|141711172|SUPERIORITY|||||||0.3587|||||||Wilcoxon Rank Sum Test|||Baseline||||0.3587
71101626|NCT04250207|141711172|SUPERIORITY|||||||0.5724|||||||Wilcoxon Rank Sum Test|||Baseline||||0.5724
71101627|NCT04250207|141711172|SUPERIORITY|||||||0.3703|||||||Wilcoxon Rank Sum Test|||Week 1||||0.3703
71101628|NCT04250207|141711172|SUPERIORITY||||||>|0.9999|||||||Wilcoxon Rank Sum Test|||Week 1||||> 0.9999
71101629|NCT04250207|141711172|SUPERIORITY|||||||0.3703|||||||Wilcoxon Rank Sum Test|||Week 2||||0.3703
71101630|NCT04250207|141711172|SUPERIORITY||||||>|0.9999|||||||Wilcoxon Rank Sum Test|||Week 2||||> 0.9999
71101631|NCT04250207|141711172|SUPERIORITY|||||||0.0257|||||||Wilcoxon Rank Sum Test|||Week 3||||0.0257
71101632|NCT04250207|141711172|SUPERIORITY|||||||0.7263|||||||Wilcoxon Rank Sum Test|||||||0.7263
71101633|NCT04250207|141711172|SUPERIORITY|||||||0.0607|||||||Wilcoxon Rank Sum Test|||Week 5||||0.0607
71101634|NCT04250207|141711172|SUPERIORITY|||||||0.046|||||||Wilcoxon Rank Sum Test|||Week 5||||0.0460
71101635|NCT04250207|141711172|SUPERIORITY|||||||0.0111|||||||Wilcoxon Rank Sum Test|||Week 7||||0.0111
71101636|NCT04250207|141711172|SUPERIORITY|||||||0.0011|||||||Wilcoxon Rank Sum Test|||Week 7||||0.0011
71101637|NCT04250207|141711172|SUPERIORITY|||||||0.02|||||||Wilcoxon Rank Sum Test|||Week 9||||0.0200
71101638|NCT04250207|141711172|SUPERIORITY|||||||0.0476|||||||Wilcoxon Rank Sum Test|||Week 9||||0.0476
71101639|NCT04250207|141711172|SUPERIORITY|||||||0.0065|||||||Wilcoxon Rank Sum Test|||Week 12||||0.0065
71101640|NCT04250207|141711172|SUPERIORITY|||||||0.0344|||||||Wilcoxon Rank Sum Test|||Week 12||||0.0344
71101641|NCT04250207|141711172|SUPERIORITY|||||||0.025|||||||Wilcoxon Rank Sum Test|||Week 16||||0.0250
71101642|NCT04250207|141711172|SUPERIORITY|||||||0.0733|||||||Wilcoxon Rank Sum Test|||Week 16||||0.0733
70925249|NCT04169373|141343671|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.5|||<|0.0001|TWO_SIDED|95.0|-2.0|-0.9|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-0.9|-2.0|<0.0001
70925250|NCT04169373|141343672|OTHER||LS Mean Difference|-3.31|||<|0.0001|TWO_SIDED|95.0|-4.5|-2.12||This comparison was not part of the pre-specified multiplicity testing sequence.|ANCOVA|ANCOVA model including treatment and screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-2.12|-4.50|<0.0001
71005027|NCT00732472|141518042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.25|STANDARD_ERROR_OF_MEAN|2.729|||TWO_SIDED|95.0|-7.89|3.39|||||Day 7, Max HR|||3.39|-7.89|
71005028|NCT00732472|141518042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.49|STANDARD_ERROR_OF_MEAN|2.899|||TWO_SIDED|95.0|1.59|13.39|||||Day 1, Max HR|||13.39|1.59|
71005029|NCT00732472|141518042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.7|STANDARD_ERROR_OF_MEAN|3.079|||TWO_SIDED|95.0|2.34|15.05|||||Day 7, Max HR|||15.05|2.34|
71005030|NCT00732472|141518042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|2.243|||TWO_SIDED|95.0|-4.8|4.34|||||Day 1, WM|||4.34|-4.80|
71005031|NCT00732472|141518042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|2.52|||TWO_SIDED|95.0|-5.09|5.4|||||Day 7, WM|||5.40|-5.09|
71005032|NCT00732472|141518042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.33|STANDARD_ERROR_OF_MEAN|2.182|||TWO_SIDED|95.0|-2.12|6.77|||||Day 1, WM|||6.77|-2.12|
71005033|NCT00732472|141518042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.51|STANDARD_ERROR_OF_MEAN|2.378|||TWO_SIDED|95.0|-7.48|2.45|||||Day 7, WM|||2.45|-7.48|
71005034|NCT00732472|141518042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.16|STANDARD_ERROR_OF_MEAN|2.282|||TWO_SIDED|95.0|1.51|10.81|||||Day 1, WM|||10.81|1.51|
71005035|NCT00732472|141518042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.06|STANDARD_ERROR_OF_MEAN|2.642|||TWO_SIDED|95.0|1.57|12.54|||||Day 7, WM|||12.54|1.57|
71005036|NCT01266876|141518064|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||Threshold for significance at ≤ 0.05.|ANCOVA|||"Each treatment group was compared to placebo using ANCOVA-derived contrasts.~A hierarchical testing procedure was applied to ensure strong control of overall Type-I error rate at 0.05 level. Order was following:~1. Alirocumab 150 mg Q2W versus placebo~2. Alirocumab 300 mg Q4W versus placebo~3. Alirocumab 200 mg Q4W versus placebo~4. Alirocumab 150 mg Q4W versus placebo~Testing continued only when high-order test was statistically significant at 5% level."||||0.0000
71005037|NCT01266876|141518064|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||Threshold for significance at ≤ 0.05.|ANCOVA|||||||0.0000
71005038|NCT01266876|141518064|SUPERIORITY_OR_OTHER|||||||0.0035|TWO_SIDED|||||Threshold for significance at ≤ 0.05.|ANCOVA|||||||0.0035
71005039|NCT01266876|141518064|SUPERIORITY_OR_OTHER|||||||0.0113|TWO_SIDED|||||Threshold for significance at ≤ 0.05.|ANCOVA|||||||0.0113
71005040|NCT01996865|141518095|OTHER||Hazard Ratio (HR)|0.8||||0.3296|TWO_SIDED|95.0|0.6|1.2|||Regression, Cox|||||1.2|0.6|0.3296
71005041|NCT01996865|141518096|OTHER||Hazard Ratio (HR)|0.7||||0.1222|TWO_SIDED|95.0|0.4|1.1|||Regression, Cox|||||1.1|0.4|0.1222
71005042|NCT03299166|141518182|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.81||0.2202|TWO_SIDED|95.0|-2.59|0.6|||Mixed Models Analysis|||Model-based summary statistics are from a mixed model with repeated measures, including fixed effects for treatment, visit, treatment-by-visit interaction, baseline score, baseline score-by-visit interaction as covariates, and participant as random effect.||0.60|-2.59|0.2202
71005043|NCT03299166|141518189|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.61||0.4508|TWO_SIDED|95.0|-1.67|0.75|||Mixed Models Analysis|||"Week 4 Analysis.~Model-based summary statistics are from a mixed model with repeated measures, including fixed effects for treatment, visit, treatment-by-visit interaction, baseline score, baseline score-by-visit interaction as covariates, and participant as random effect."||0.75|-1.67|0.4508
71005044|NCT03299166|141518189|SUPERIORITY||LS Mean Difference|-1.54|STANDARD_ERROR_OF_MEAN|0.75||0.041|TWO_SIDED|95.0|-3.02|-0.06|||Mixed Models Analysis|||"Week 8 Analysis.~Model-based summary statistics are from a mixed model with repeated measures, including fixed effects for treatment, visit, treatment-by-visit interaction, baseline score, baseline score-by-visit interaction as covariates, and participant as random effect."||-0.06|-3.02|0.0410
71005045|NCT00572728|141518190|SUPERIORITY_OR_OTHER||AUC|0.68|STANDARD_ERROR_OF_MEAN|0.1||0.046|ONE_SIDED|95.0||0.83||The Delong method was used to test if the observed AUC was significantly different than 0.5 with the one-sided p value DeLong ER, DeLong DM, Clarke-Pearson DL, Biometrics (1988)|Delong method|one-sided p-value|"percent change in SUVmax was computed as: %ΔSUVmax = 100\*(FLT1-FLT2)/FLT1 a 90% 2-sided confidence interval was constructed from 2000 Bootstrapping estimates from which the 1-sided 95% CI was derived.~Hanley SE(AUC) reported."|"A receiver operating characteristic (ROC) analysis was performed to assess the significance of the Area Under the Curve (AUC) under the Null Hypothesis with a one sided alpha=0.05 (95% one-sided CL):~H0: AUC = 0.50 (no difference from guessing) given the alternative hypothesis: Ha:AUC \>= 0.75 AUC = ROC(%ΔSUVmax\| path response) where percent change (%ΔSUVmax ) was defined as (SUVmax at FLT1 -SUVmax at FLT2)/SUVmax at FLT1 x 100"||.83||0.046
71005046|NCT00572728|141518191|SUPERIORITY_OR_OTHER||spearman correlation|0.35||||0.002|TWO_SIDED|95.0|0.13|0.54|||spearman correlation method||This estimate uses the Fisher's z Transformation to adjust for bias in the Spearman Correlation Statistic|H0: ρ = 0; that is, there is no correlation between SUVmax @ FLT-1 and Ki-67 LI a Fisher's z Transformation was applied to adjust for bias in the Spearman Correlation Statistic||0.54|0.13|0.002
71101643|NCT04250207|141711172|SUPERIORITY|||||||0.0072|||||||Wilcoxon Rank Sum Test|||Week 20||||0.0072
71101644|NCT04250207|141711172|SUPERIORITY|||||||0.1124|||||||Wilcoxon Rank Sum Test|||Week 20||||0.1124
71005047|NCT00572728|141518192|SUPERIORITY_OR_OTHER||Spearman Correlation|0.67|||<|0.0001|TWO_SIDED|95.0|0.47|0.81|||Spearman Correlation method|we use Fisher's z Transformation to adjust for bias in the Spearman Correlation Statistic|this estimate uses the Fisher's z Transformation to adjust for bias in the Spearman Correlation Statistic|H0: ρ = 0; that is, there is no correlation between SUVmax @ FLT-3 and Ki-67 LI||0.81|0.47|<0.0001
71005048|NCT00572728|141518193|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|two-sided exact p value from Wilcoxon two-sample test||"H0: Mean SUVmax (RCB 0,I) = Mean SUVmax (RCB II,III) After dichotomization, Wilcoxon two-sample test was used to compare uptake values between RCB groups.~In other words, we are comparing the means (of SUVmax) @ FLT1 between the RCB 0,I and the RCB II,III groups.."||||0.66
71005049|NCT00572728|141518194|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|\*two-sided exact p value from Wilcoxon two-sample test||H0: SUVmax (RCB 0,I) = SUVmax (RCB II,III) in other words, we are comparing the SUVmax @ FLT2 between the RCB 0,I and the RCB II,III groups.||||0.86
71005050|NCT00572728|141518195|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|two-sided exact p value from Wilcoxon two-sample test||H0: SUVmax (RCB 0,I) = SUVmax (RCB II,III) in other words, we are comparing the SUVmax @ FLT3 between the RCB 0,I and the RCB II,III groups.||||0.010
71005051|NCT00572728|141518195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.013|TWO_SIDED|95.0|0.76|0.97|||Regression, Logistic|||H0: %SUVmax FLT1-FLT3 (RCB 0,I) = %SUVmax FLT1-FLT3 (RCB II,III) A logistic regression model is used to determine if a larger percent change in SUVmax is associated with (RCB 0,I); the null hypothesis assumes that there is no association.||0.97|0.76|0.013
71044642|NCT01138826|141598212|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUClast of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|103.88|||||TWO_SIDED|90.0|97.27|110.94||||||||110.94|97.27|
71044643|NCT01138826|141598212|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUClast of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|104.26|||||TWO_SIDED|90.0|97.67|111.3||||||||111.30|97.67|
71044644|NCT01138826|141598212|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUClast of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|100.37|||||TWO_SIDED|90.0|94.02|107.15||||||||107.15|94.02|
71044645|NCT01138826|141598213|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed Cmax of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|98.39|||||TWO_SIDED|90.0|91.05|106.33||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1146 on the natural log scale for Cmax with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1366 for loge Cmax.||106.33|91.05|
71044646|NCT01138826|141598213|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed Cmax of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|95.22|||||TWO_SIDED|90.0|88.16|102.84||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1146 on the natural log scale for Cmax with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1366 for loge Cmax.||102.84|88.16|
71044647|NCT01138826|141598213|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed Cmax of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|96.77|||||TWO_SIDED|90.0|89.58|104.54||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1146 on the natural log scale for Cmax with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1366 for loge Cmax.||104.54|89.58|
71044648|NCT03360916|141598229|SUPERIORITY||Mean Difference (Net)|2.29|STANDARD_DEVIATION|125.59||0.953|TWO_SIDED||||||t-test, 2 sided|This is within group 3 month change||||||0.9530
71044649|NCT03360916|141598229|SUPERIORITY||Mean Difference (Net)|-11.24|STANDARD_DEVIATION|130.12||0.7908|TWO_SIDED||||||t-test, 2 sided|This is within group 3 month change||||||0.7908
71044650|NCT03360916|141598229|SUPERIORITY||Mean Difference (Net)|44.88|STANDARD_DEVIATION|105.19||0.1344|TWO_SIDED||||||t-test, 2 sided|This is within group 3 month change||||||0.1344
71044651|NCT03360916|141598230|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_DEVIATION|0.18||0.0005|TWO_SIDED||||||t-test, 2 sided|This is within group 3 month change||||||0.0005
71044652|NCT03360916|141598230|SUPERIORITY||Mean Difference (Net)|0.23|STANDARD_DEVIATION|0.21||0.0021|TWO_SIDED||||||t-test, 2 sided|This is within group 3 month change||||||0.0021
71101645|NCT04250207|141711172|SUPERIORITY|||||||0.0199|||||||Wilcoxon Rank Sum Test|||Week 24||||0.0199
71005052|NCT00572728|141518196|SUPERIORITY_OR_OTHER||AUC|0.83|||<|0.001|TWO_SIDED|90.0|0.72|0.94||Delong 1-sided p-value (alpha=0.05)|Delong Method|The Delong-Delong Clark-Pearson method using modified U-statistics was used to evaluate the AUC||"ROC analysis was used to compute the AUC and evaluate if %ΔSUVmax FLT1-FLT3 is predictive of pCR with alpha=0.05.~The Null Hypothesis assumes that the P(%ΔSUVmax FLT1-FLT3\|pCR)= 1 - P(%ΔSUVmax FLT1-FLT3\|non-pCR) that is: H0: AUC =0.5 (guessing)"||.94|.72|<0.001
71005053|NCT00572728|141518197|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Kruskal-Wallis|two-sided p value from Kruskal-Wallis one-way ANOVA||"Kruskal-Wallis one-way ANOVA was used to test whether there was a difference in %SUVmax (FLT1-FLT2) among LN statuses.~H0: no difference between the 3 LN status."||||0.86
71044653|NCT03360916|141598230|SUPERIORITY||Mean Difference (Net)|0.21|STANDARD_DEVIATION|0.23||0.0025|TWO_SIDED||||||t-test, 2 sided|This is within group 3 month change||||||0.0025
71044654|NCT00619359|141598232|NON_INFERIORITY_OR_EQUIVALENCE|If the CI for the difference in response rates (Fosaprepitant minus Aprepitant), calculated using the methodology of Miettinen and Nurminen, had a lower limit ≥7 percentage points, fosaprepitant was considered at least as effective as aprepitant for Complete Response in the overall phase. Study had 90% power to detect non-inferiority for this outcome measure.|Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|3.7||||95.0|-4.1|3.3||||||||3.3|-4.1|
71005054|NCT00572728|141518198|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED|||||two-sided p value from Kruskal-Wallis one-way ANOVA|Kruskal-Wallis|||||||0.67
71101646|NCT04250207|141711172|SUPERIORITY|||||||0.2331|||||||Wilcoxon Rank Sum Test|||Week 24||||0.2331
71101647|NCT04250207|141711172|SUPERIORITY|||||||0.0024|||||||Wilcoxon Rank Sum Test|||Week 38||||0.0024
71005055|NCT02735044|141518342|NON_INFERIORITY|Non-inferiority of HOE901-U300 versus Lantus was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for the difference in the mean change in HbA1c from baseline to month 6 was \<0.3%.|LS Mean difference|0.004|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.172|0.179||||||Analysis was performed using ANCOVA models which included the treatment group, the randomization stratum of age group at screening visit (\<12 years and \>=12 years), and the continuous fixed covariates of the baseline HbA1c value.||0.179|-0.172|
71005056|NCT02735044|141518342|SUPERIORITY|Superiority of HOE901-U300 versus Lantus was demonstrated if the upper bound of the two-sided 95% CI for the difference between treatment groups was \<0 (zero).||||||0.965||||||Threshold for significance at 0.025 level.|ANCOVA|||A step-wise closed testing approach was used to control the type I error. Analysis was performed using ANCOVA models which included the treatment group, the randomization stratum of age group at screening visit (\<12 years and \>=12 years), and the continuous fixed covariates of the baseline HbA1c value.||||0.965
71044655|NCT00619359|141598233|NON_INFERIORITY_OR_EQUIVALENCE|If the CI for the difference in response rates, calculated using the methodology of Miettinen and Nurminen, had a lower limit ≥7.3 percentage points, fosaprepitant was considered at least as effective as aprepitant for Complete Response in the delayed phase.|Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|3.6||||95.0|-3.5|3.7||||||||3.7|-3.5|
71044656|NCT00619359|141598234|NON_INFERIORITY_OR_EQUIVALENCE|If the CI for the difference in response rates, calculated using the methodology of Miettinen and Nurminen, had a lower limit ≥8.2 percentage points, fosaprepitant was considered at least as effective as aprepitant for No Vomiting in the overall phase.|Risk Difference (RD)|-1.7|STANDARD_ERROR_OF_MEAN|3.6||||95.0|-5.3|2.0||||||||2.0|-5.3|
71044657|NCT02502734|141598235|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be demonstrated if the lower limit of the confidence interval (0.025, 1-sided significance test level) for the mean difference in lower-leg growth rate of FF 50 mcg OD versus Placebo was greater than -0.20mm/week.|Mean Difference (Final Values)|-0.052|||||TWO_SIDED|95.0|-0.1217|0.0176||Non-inferiority would be demonstrated if the lower limit of the confidence interval (0.025,1-sided significance test level) for the mean difference in lower-leg growth rate of FF 50 mcg OD versus Placebo was greater than -0.20mm/week.|ANCOVA|Analysis performed using ANCOVA with covariates period-level baseline and subject-level baseline lower-leg length, age, gender, treatment and period.||||0.0176|-0.1217|
71101648|NCT04250207|141711172|SUPERIORITY|||||||0.1672|||||||Wilcoxon Rank Sum Test|||Week 38||||0.1672
71044658|NCT00707447|141598325|SUPERIORITY_OR_OTHER||||||<|0.05||||||There was only one primary outcome variable, thus no adjustments for multiple comparisons were made.|t-test, 2 sided|||independent t-tests for between group comparisons, dependent t-tests for within group comparisons||||<.05
71044659|NCT00707447|141598326|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||independent t-tests for between group comparisons, dependent t-tests for within group comparisons||||<.05
71044660|NCT00707447|141598327|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
71044661|NCT00707447|141598328|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
71044662|NCT00707447|141598329|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
71044663|NCT00707447|141598330|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
71044664|NCT00707447|141598331|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
71044665|NCT00707447|141598332|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
71044666|NCT00707447|141598333|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
71044667|NCT00707447|141598334|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
71044668|NCT00508027|141598335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5|STANDARD_DEVIATION|1.7|<|0.05|||||||t-test, 2 sided|||Ho: There is no change in plasma biomarker levels before and after simivastatin treatment. With 12 patients in each group and assuming a 5% risk of Type I error (two-tailed α = 0.05) and estimated SD for the change in NOx (or sVCAM-1) of 48%, power will be 80% to detect a 40% change from baseline for each group, and a 55% difference in the change in biomarker levels between dose groups. Matched paired t-tests were used to measure changes in biomarker levels from baseline.||||<0.05
71101649|NCT04250207|141711172|SUPERIORITY|||||||0.0047|||||||Wilcoxon Rank Sum Test|||Week 52||||0.0047
71044669|NCT03208673|141598365|SUPERIORITY||Ratio of Geometric mean|0.5628||||0.001|TWO_SIDED|95.0|0.4395|0.7204|||t-test, 2 sided|||||0.7204|0.4395|.001
71044670|NCT03208673|141598366|SUPERIORITY|||||||0.025|||||||t-test, 1 sided|||Nasal||||0.025
71044671|NCT03208673|141598366|SUPERIORITY|||||||0.312|||||||t-test, 1 sided|||Temporal||||0.312
71044672|NCT03208673|141598367|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Comfort||||<0.001
71044673|NCT03208673|141598367|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Dry||||<0.001
71044674|NCT03208673|141598367|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Gritty||||<0.001
71044675|NCT03208673|141598367|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Vision||||<0.001
71101650|NCT04250207|141711172|SUPERIORITY|||||||0.0625|||||||Wilcoxon Rank Sum Test|||Week 52||||0.0625
71101651|NCT04250207|141711173|SUPERIORITY|||||||0.2434|||||||Wilcoxon Rank Sum Test|||Week 1||||0.2434
71101652|NCT04250207|141711173|SUPERIORITY|||||||0.2126|||||||Wilcoxon Rank Sum Test|||Week 1||||0.2126
71101653|NCT04250207|141711173|SUPERIORITY|||||||0.079|||||||Wilcoxon Rank Sum Test|||Week 2||||0.0790
71101654|NCT04250207|141711173|SUPERIORITY|||||||0.3043|||||||Wilcoxon Rank Sum Test|||Week 2||||0.3043
71101655|NCT04250207|141711173|SUPERIORITY|||||||0.0357|||||||Wilcoxon Rank Sum Test|||Week 3||||0.0357
71101656|NCT04250207|141711173|SUPERIORITY|||||||0.0803|||||||Wilcoxon Rank Sum Test|||Week 3||||0.0803
71101657|NCT04250207|141711173|SUPERIORITY|||||||0.015|||||||Wilcoxon Rank Sum Test|||Week 5||||0.0150
71101658|NCT04250207|141711173|SUPERIORITY|||||||0.0012|||||||Wilcoxon Rank Sum Test|||Week 5||||0.0012
71044676|NCT03891329|141598369|OTHER|No comparison of two groups, just single arm design|SADE-free rate in the study group|0.98||||0.05|TWO_SIDED|95.0|0.9|1.0|||t-test, 2 sided|||"Serious Adverse Device Effects (SADE) possibly or securely related to the Cor Family devices until the 3- month follow-up are counted for this primary endpoint.~The following hypothesis has been defined:~Ho: SADE-free rate through 3 months post-implant ≤ 90.0% Ha: SADE-free rate through 3 months post-implant \> 90.0%"||1|0.9|0.05
71044677|NCT03891329|141598370|OTHER|Kaplan-Meier method|||||||||||||||||The Kaplan-Meier method will be applied to estimate the 3-month SADE-free rate at 92 days after implantation (sensitivity analysis of the primary endpoint) and the 12-month SADE-free rate at 365 days after implantation.|||
71044678|NCT02740179|141598373|SUPERIORITY|||||||0.72||||||P value for Change in Coronary Flow Reserve on Cardiac PET|t-test, 2 sided|||||||0.72
71044679|NCT02740179|141598374|SUPERIORITY|||||||0.03||||||P value for Change in Stress Myocardial Blood Flow on Cardiac MRI|t-test, 2 sided|||||||0.03
71044680|NCT02740179|141598375|SUPERIORITY|||||||0.38|||||||Kruskal-Wallis|||||||0.38
71044681|NCT02740179|141598376|SUPERIORITY|||||||0.09|||||||Kruskal-Wallis|||||||0.09
71044682|NCT02740179|141598377|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|Analyses performed on log transformation of data||||||0.03
71005057|NCT01682759|141518357|NON_INFERIORITY_OR_EQUIVALENCE|Omarigliptin was considered non-inferior to glimepiride if the upper bound of the two-sided 95% confidence interval (CI) of the between-treatment difference in least-squares (LS) means for change from baseline in A1C at Week 54 (omarigliptin vs. glimepiride) was lower than 0.35%.|Difference in the least squares means|0.18|||||TWO_SIDED|95.0|0.06|0.3|||||Constrained longitudinal data analysis (cLDA) model including terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups.|||0.30|0.06|
71005058|NCT01682759|141518358|SUPERIORITY_OR_OTHER||Difference in percentages|-6.9|||||TWO_SIDED|95.0|-13.9|0.1|||||Miettinen \& Nurminen method; the 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.|||0.1|-13.9|
71005059|NCT01682759|141518359|SUPERIORITY_OR_OTHER||Difference in percentages|1.1|||||TWO_SIDED|95.0|-1.6|3.8|||||Miettinen \& Nurminen method; the 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.|||3.8|-1.6|
71005060|NCT01682759|141518360|SUPERIORITY_OR_OTHER||Difference in the least squares means|5.6|||||TWO_SIDED|95.0|0.1|11.2|||||cLDA model including terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups|||11.2|0.1|
71005061|NCT01682759|141518361|SUPERIORITY_OR_OTHER||Between-group Rate Difference (%)|-3.7|||||TWO_SIDED|95.0|-10.6|3.3|||||Between-group CIs are calculated via Miettinen \& Nurminen method.|A1C \<6.5%||3.3|-10.6|
71005062|NCT01682759|141518362|SUPERIORITY_OR_OTHER||Difference in percentages|-21.3|||<|0.001|TWO_SIDED|95.0|-26.5|-16.4|||Difference in percentages||Miettinen \& Nurminen method; the 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.|||-16.4|-26.5|<0.001
71005063|NCT01682759|141518363|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.9|||<|0.001|TWO_SIDED|95.0|-2.5|-1.4|||Difference in the least squares means||cLDA model including terms for treatment, time, and the interaction of time by treatment with the constraint that the mean baseline is the same for all treatment groups.|||-1.4|-2.5|<0.001
71005064|NCT01682759|141518364|SUPERIORITY_OR_OTHER||Between-group Rate Difference|-10.3|||||TWO_SIDED|95.0|-17.8|-2.8|||||Between-group CIs are calculated via Miettinen \& Nurminen method.|A1C \< 7.0%||-2.8|-17.8|
71005065|NCT01868594|141518372|SUPERIORITY|||||||0.019||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.019
71005066|NCT01868594|141518373|SUPERIORITY|||||||0.0432||||||"The p-value associated with treatment factor of changes from baseline to Week 4, 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.0432
71044683|NCT02740179|141598378|SUPERIORITY|||||||0.09||||||P value for Change in Plasma IL-6|t-test, 2 sided|Analyses performed after log transformation of data||||||0.09
71044684|NCT02740179|141598379|SUPERIORITY|||||||0.36||||||P value for Change in Plasma hsCRP|t-test, 2 sided|Analyses performed after log transformation of data||||||0.36
71005067|NCT01868594|141518374|SUPERIORITY|||||||0.7344||||||"The p-value associated with treatment factor of changes from baseline to Week 4, 8, 12, 18, 24, 30 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.7344
71005068|NCT01868594|141518375|SUPERIORITY|||||||0.278||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of Total cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.2780
71005069|NCT01868594|141518375|SUPERIORITY|||||||0.8114||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of HDL cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.8114
71005070|NCT01868594|141518375|SUPERIORITY|||||||0.1619||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of LDL cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.1619
71044685|NCT02740179|141598380|SUPERIORITY|||||||0.88||||||P value for Change in Plasma MCP-1|t-test, 2 sided|Analyses performed after log transformation of data||||||0.88
71044686|NCT02740179|141598381|SUPERIORITY|||||||0.17||||||P value for Change in Plasma sCD163|t-test, 2 sided|Analyses performed after log transformation of data||||||0.17
71044687|NCT02740179|141598382|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|Analyses performed after log transformation of data||||||0.28
71044688|NCT02740179|141598383|SUPERIORITY|||||||0.32|||||||Kruskal-Wallis|||||||0.32
70925251|NCT04169373|141343673|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-0.65|||<|0.0001|TWO_SIDED|95.0|-0.85|-0.45|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-0.45|-0.85|<0.0001
70925252|NCT04169373|141343674|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-3.06|||<|0.0001|TWO_SIDED|95.0|-4.08|-2.04|||ANCOVA|ANCOVA model including treatment, main stratification factor, treatment and stratification factor interaction and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-2.04|-4.08|<0.0001
70925253|NCT04169373|141343675|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|20.1||||0.0001|TWO_SIDED|95.0|10.1|30.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||30.1|10.1|0.0001
70925254|NCT04169373|141343675|OTHER||Odds Ratio (OR)|2.6|||||TWO_SIDED|95.0|1.6|4.2|||||Upadacitinib : Placebo|A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.||4.2|1.6|
70925255|NCT04169373|141343676|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|8.8||||0.0063|TWO_SIDED|95.0|2.5|15.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||15.2|2.5|0.0063
70925256|NCT04169373|141343676|OTHER||Odds Ratio (OR)|3.0|||||TWO_SIDED|95.0|1.3|7.0|||||Upadacitinib : Placebo|A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.||7.0|1.3|
71005071|NCT01868594|141518375|SUPERIORITY|||||||0.0764||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of Triglycerides changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.0764
71005072|NCT01868594|141518376|SUPERIORITY|||||||0.3107||||||The p-value associated with comparison of changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||Analysis of basal insulin changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.||||0.3107
71005073|NCT01868594|141518376|SUPERIORITY|||||||0.5236||||||The p-value associated with comparison of changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||Analysis of prandial insulin changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.||||0.5236
71005074|NCT01868594|141518376|SUPERIORITY|||||||0.3847||||||The p-value associated with comparison of changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||Analysis of total daily dose insulin changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.||||0.3847
71005075|NCT01868594|141518377|SUPERIORITY|||||||0.6716|||||||t-test, 2 sided|||||||0.6716
71005076|NCT01868594|141518378|SUPERIORITY|||||||0.2484||||||The p-value associated with comparison of Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||Analysis of total Treatment Satisfaction score at Week 36 endpoint between Subetta and Placebo treatment groups.||||0.2484
71005077|NCT01868594|141518378|SUPERIORITY|||||||0.761||||||The p-value associated with comparison of Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||"Analysis of Perceived Hyperglycaemia question at Week 36 endpoint between Subetta and Placebo treatment groups."||||0.7610
71005078|NCT01868594|141518378|SUPERIORITY|||||||0.3714||||||The p-value associated with comparison of Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||"Analysis of Perceived Hypoglycemia question at Week 36 endpoint between Subetta and Placebo treatment groups."||||0.3714
71005079|NCT01201967|141518382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.68||||0.002|TWO_SIDED|95.0|2.14|9.22|||Mixed Models Analysis|||||9.22|2.14|0.002
71005080|NCT01201967|141518383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05||||0.045|TWO_SIDED|95.0|-4.06|-0.05|||Mixed Models Analysis|||||-0.05|-4.06|0.045
71005081|NCT01201967|141518384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.55|TWO_SIDED|95.0|-0.93|1.76|||Mixed Models Analysis|||||1.76|-0.93|0.55
71005082|NCT01201967|141518385|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|11.4|||<|0.001|TWO_SIDED|95.0|5.2|24.9|||Chi-squared|||||24.9|5.20|<0.001
71044689|NCT02740179|141598384|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
71005083|NCT01201967|141518386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.28|TWO_SIDED|95.0|-0.51|1.76|||Mixed Models Analysis|||||1.76|-0.51|0.28
71005084|NCT01201967|141518387|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96||||0.83|TWO_SIDED|95.0|0.63|1.46|||Chi-squared|||||1.46|0.63|0.83
71005085|NCT01201967|141518388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.029|TWO_SIDED|95.0|0.012|0.22|||Mixed Models Analysis|||||0.22|0.012|0.029
71005086|NCT01201967|141518389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.59||||0.005|TWO_SIDED|95.0|1.71|9.46|||Mixed Models Analysis|||||9.46|1.71|0.005
71044690|NCT02740179|141598385|SUPERIORITY|||||||0.73|||||||Kruskal-Wallis|||||||0.73
71044691|NCT02740179|141598386|SUPERIORITY|||||||0.56|||||||Kruskal-Wallis|||||||0.56
71005087|NCT01201967|141518390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3||||0.11|TWO_SIDED|95.0|-0.54|5.14|||Mixed Models Analysis|||||5.14|-0.54|0.11
71005088|NCT03128307|141518416|SUPERIORITY||||||<|0.0001||||||Assuming a priori threshold for statistical significant of p = 0.05|t-test, 2 sided|||||||< 0.0001
71005089|NCT03128307|141518417|SUPERIORITY||||||<|0.0001||||||a priori threshold for statistical significance of p = 0.05|t-test, 2 sided|||||||< 0.0001
71044692|NCT02740179|141598387|SUPERIORITY|||||||0.03|||||||Kruskal-Wallis|||||||0.03
71044693|NCT02740179|141598388|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
71044694|NCT02377921|141598483|SUPERIORITY||Least Squares (LS) Mean Difference|0.74||||0.5387|TWO_SIDED|95.0|-1.61|3.09||Generalized estimating equation (GEE) model includes change from Baseline (BL) as dependent variable, visit, treatment and visit by treatment as fixed factors, and BL values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference = Ace-ER - placebo|||3.09|-1.61|0.5387
71044695|NCT02377921|141598484|SUPERIORITY||LS Mean Difference|-0.4||||0.6938|TWO_SIDED|95.0|-2.38|1.58||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference = Ace-ER - placebo|||1.58|-2.38|0.6938
71101659|NCT04250207|141711173|SUPERIORITY|||||||0.0314|||||||Wilcoxon Rank Sum Test|||Week 7||||0.0314
71005090|NCT01693562|141518461|EQUIVALENCE|Other||||||0.016|||||||Regression, Cox|||||||0.016
71005091|NCT01693562|141518462|EQUIVALENCE|Other||||||0.0046|||||||Regression, Cox|||||||0.0046
71005092|NCT02987205|141518485|NON_INFERIORITY|If the upper bound of this 95% CI was less than the prespecified non-inferiority limit of 0.50, the Test product would be claimed to be non-inferior to the Comparator product.||||||0.013||||||Wilcoxon matched-pairs signed rank test|Wilcoxon (Mann-Whitney)|||||||0.0130
71005093|NCT03057106|141518490|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.46|TWO_SIDED|90.0|0.67|1.16||2-sided, adjusted for stratification factors at rtandomization.|Log Rank|||||1.16|0.67|0.46
71005094|NCT03057106|141518491|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.0035|TWO_SIDED|95.0|0.52|0.88||2-sided, adjusted for stratification factors at randomization.|Log Rank|Adjusted for stratification factors at randomization.||||0.88|0.52|0.0035
71005095|NCT03057106|141518492|SUPERIORITY||Odds Ratio (OR)|1.69||||0.033|TWO_SIDED|95.0|1.04|2.76||2-sided, adjusted for stratification factors at randomization.|Cochran-Mantel-Haenszel|||||2.76|1.04|0.033
71005096|NCT02362594|141518493|SUPERIORITY||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|98.4|0.43|0.74||One-sided p-value based on log-rank test.|Regression, Cox|||Comparison of RFS time-to-event distribution between the 2 treatment arms was based on Cox regression model with treatment as a covariate stratified by stage (IIIA \[\>1 mm metastasis\] vs. IIIB vs. IIIC 1-3 nodes vs. IIIC ≥4 nodes) as indicated at randomization.||0.74|0.43|<0.0001
71005097|NCT02362594|141518494|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.42|0.69||One-sided p-value based on log-rank test.|Regression, Cox|||Comparison of RFS time-to-event distribution between the 2 treatment arms (PD-L1-positive participants) was based on Cox regression model with treatment as a covariate stratified by stage (IIIA \[\>1 mm metastasis\] vs. IIIB vs. IIIC 1-3 nodes vs. IIIC ≥4 nodes) as indicated at randomization.||0.69|0.42|<0.0001
71005098|NCT04167514|141518504|SUPERIORITY||Odds Ratio (OR)|1.92||||0.034|TWO_SIDED|95.0|0.954|3.866|||One-sided Wald|One-sided Wald test of superior odds of overall response under AAT treatment compared to placebo.Threshold of significance at \<0.025.|Wald CIs|||3.866|0.954|0.034
71005099|NCT03991936|141518517|SUPERIORITY||Mean Difference (Net)|-2.635|||<|0.001|TWO_SIDED|||||The threshold for statistical analysis was p = 0.05|t-test, 2 sided|||The null hypothesis was that the change from baseline to 24 weeks in the Nail Psoriasis Severity Index (NAPSI) for the triamcinolone acetonide groups: 2.5 mg/mL, 5.0 mg/mL, 7.5 mg/mL, and 10 mg/mL would be no different than the change from baseline to 24 weeks for the placebo group.||||<0.001
71005100|NCT03258593|141518563|OTHER|Location Tests (Wilcoxon Rank sum test)|Median Difference (Net)|67.5||||0.202|TWO_SIDED|95.0|25.0|75.0||Unadjusted p-value|Wilcoxon Rank sum test|||||75|25|0.202
71005101|NCT03258593|141518563|OTHER|Location Tests (Wilcoxon Rank sum test)|Median Difference (Net)|114.0||||0.667|TWO_SIDED|95.0|67.9|160.3||Unadjusted p-value|Wilcoxon Rank sum test|||||160.3|67.9|0.667
71005102|NCT03258593|141518563|OTHER|Location Tests (Wilcoxon Rank sum test)|Median Difference (Net)|44.1||||0.463|TWO_SIDED|95.0|25.0|75.0|||Wilcoxon Rank sum test|||||75|25|0.463
71005103|NCT03258593|141518565|OTHER|Location test (Rank sum based i.e., Wilcoxon test)|Median Difference (Net)|-17.75||||0.863|TWO_SIDED|95.0|-211.6|170.3|||Wilcoxon Rank sum test||Median change; Signed Rank (S/R) of post-treatment PDL-1 levels minus baseline.|||170.3|-211.6|0.863
71005104|NCT03258593|141518565|OTHER|Location test (Rank sum based i.e., Wilcoxon test)|Median Difference (Net)|114.1||||0.666|TWO_SIDED|95.0|67.9|160.3|||Wilcoxon Rank sum test||Median change; Signed Rank (S/R) of post-treatment PDL-1 levels minus baseline.|||160.3|67.9|0.666
71005105|NCT03258593|141518565|OTHER|Location test (Rank sum based i.e., Wilcoxon test)|Median Difference (Net)|21.3||||0.949|TWO_SIDED|95.0|-203.9|269.9|||Wilcoxon Rank sum test||Median change; Signed Rank (S/R) of post-treatment PDL-1 levels minus baseline.|||269.9|-203.9|0.949
71005106|NCT03258593|141518567|OTHER|Other: median difference|Median Difference (Net)|4.34|||<|0.001|TWO_SIDED|95.0|1.7|38.0||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interferon Gamma (IFN-γ) at 3 weeks compared to their respective baseline values.||38.0|1.7|<0.001
71005107|NCT03258593|141518567|OTHER|Other: median difference|Median Difference (Net)|3.29|||<|0.001|TWO_SIDED|95.0|1.5|11.25||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interferon Gamma (IFN-γ) at 5 weeks compared to their respective baseline values.||11.25|1.5|<0.001
71005108|NCT03258593|141518567|OTHER|Other: median difference|Median Difference (Net)|0.4|||<|0.05|TWO_SIDED|95.0|0.1|0.7||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Tumor Necrosis Factor Alpha (TNF-α) at 3 weeks compared to their respective baseline values.||0.7|0.1|<0.05
71005109|NCT03258593|141518567|OTHER|Other: median difference|Median Difference (Net)|0.24||||0.052|TWO_SIDED|95.0|-0.01|0.96||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Tumor Necrosis Factor Alpha (TNF-α ) at 5 weeks compared to their respective baseline values.||0.96|-0.01|0.052
70925257|NCT04169373|141343677|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-0.92||||0.0004|TWO_SIDED|95.0|-1.42|-0.41|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-0.41|-1.42|0.0004
70925258|NCT04169373|141343678|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.12||||0.0001|TWO_SIDED|95.0|-1.68|-0.55|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-0.55|-1.68|0.0001
70925259|NCT04169373|141343679|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|23.8|||<|0.0001|TWO_SIDED|95.0|14.2|33.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||33.4|14.2|<0.0001
70925260|NCT04169373|141343679|OTHER||Odds Ratio (OR)|3.2|||||TWO_SIDED|95.0|1.9|5.4|||||Upadacitinib : Placebo|A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.||5.4|1.9|
70925261|NCT04169373|141343680|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|10.9||||0.0035|TWO_SIDED|95.0|3.6|18.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||18.3|3.6|0.0035
70925262|NCT04169373|141343680|OTHER||Odds Ratio (OR)|2.7|||||TWO_SIDED|95.0|1.3|5.6|||||Upadacitinib : Placebo|A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.||5.6|1.3|
71005110|NCT03258593|141518567|OTHER|Other: median difference|Median Difference (Net)|0.39||||0.055|TWO_SIDED|95.0|-0.03|4.61||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interleukin 6 (IL-6) at 3 weeks as compared to their respective baseline values.||4.61|-0.03|0.055
71005111|NCT03258593|141518567|OTHER|Other: median difference|Median Difference (Net)|0.54||||0.06|TWO_SIDED|95.0|-0.06|1.96|||Paired samples Wilcoxon rank sum test|Hochberg adjustment may be used.||Interleukin 6 (IL-6) at 5 weeks as compared to their respective baseline values.||1.96|-0.06|0.06
71005112|NCT03258593|141518567|OTHER|Other: median difference|Median Difference (Net)|0.73||||0.42|TWO_SIDED|95.0|-1.63|1.62||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interleukin 8 (IL-8) at 3 weeks as compared to their respective baseline values.||1.62|-1.63|0.420
71005113|NCT03258593|141518567|OTHER|Other: median difference|Median Difference (Net)|-0.39||||0.733|TWO_SIDED|95.0|-1.315|1.31||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interleukin 8 (IL-8) at 5 weeks as compared to their respective baseline values.||1.31|-1.315|0.733
71005114|NCT03258593|141518567|OTHER|Other: median difference|Median Difference (Net)|0.12||||0.01|TWO_SIDED|95.0|0.04|0.21||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interleukin 10 (IL-10) at 3 weeks as compared to their respective baseline values.||0.21|0.04|0.010
71005115|NCT03258593|141518567|OTHER|Other: median difference|Median Difference (Net)|0.1||||0.014|TWO_SIDED|95.0|0.04|0.4||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interleukin 10 (IL-10) at 5 weeks as compared to their respective baseline values.||0.40|0.04|0.014
71005116|NCT03258593|141518569|OTHER|One curve estimated in this cohort. Not compared to any other curves.|Kaplan-Meier product-limit|13.2|||||TWO_SIDED|97.5|2.5|97.5||Unadjusted p-value|Kaplan-Meier product-limit estimates|||Disease free survival time was evaluated with the product-limit estimator by Kaplan-Meier test.||97.5|2.5|
71044696|NCT02377921|141598485|SUPERIORITY||LS Mean Difference|-1.49||||0.5023|TWO_SIDED|95.0|-5.83|2.86||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference = Ace-ER - placebo|||2.86|-5.83|0.5023
71044697|NCT02377921|141598486|SUPERIORITY||LS Mean Difference|-0.72||||0.2739|TWO_SIDED|95.0|-2.01|0.57||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference = Ace-ER - placebo|||0.57|-2.01|0.2739
71044698|NCT02377921|141598487|SUPERIORITY||LS Mean Difference|-2.76||||0.1235|TWO_SIDED|95.0|-6.27|0.75||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference: Ace-ER 6 g/day - placebo|||0.75|-6.27|0.1235
71044699|NCT02377921|141598488|SUPERIORITY||LS Mean Difference|-0.43||||0.3907|TWO_SIDED|95.0|-1.4|0.55||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference: Ace-ER 6 g/day - placebo|||0.55|-1.40|0.3907
71044700|NCT02377921|141598489|OTHER||LS Mean Difference|-10.98||||0.1964|TWO_SIDED|95.0|-27.64|5.68||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference: Ace-ER 6 g/day - placebo|||5.68|-27.64|0.1964
71005117|NCT05085275|141518626|NON_INFERIORITY|The study planned to enroll 400 patients (200 patients in each treatment arm) to achieve 90% power to detect a hazard ratio (HR) of 0.60 for the primary composite endpoint, with differences between treatment groups assessed using a 2-sided alpha of \<0.05|Hazard Ratio (HR)|0.73||||0.1602|TWO_SIDED|95.0|0.46|1.14|||Regression, Cox|||||1.14|0.46|.1602
71005118|NCT05085275|141518628|OTHER||Hazard Ratio (HR)|0.78|STANDARD_ERROR_OF_MEAN|0.2392||0.3|||||||Regression, Cox|||||||.30
71005119|NCT05085275|141518629|OTHER||Hazard Ratio (HR)|0.35|STANDARD_ERROR_OF_MEAN|0.8295||0.17|||||||Regression, Cox|||||||0.17
71005120|NCT04453722|141518637|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test.|Median Difference (Final Values)|-0.1||||0.12|TWO_SIDED|95.0|-0.4|0.0|||Wilcoxon (Mann-Whitney)|||variable: In hospital TWA SpO2 \<90% (%)||0|-0.4|0.120
71005121|NCT04453722|141518637|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test|Median Difference (Final Values)|-407.0||||0.349|TWO_SIDED|95.0|-1816.0|208.0|||Wilcoxon (Mann-Whitney)|||variable: In hospital AUC SpO2 \<90% (% \* min)||208|-1816|0.349
71005122|NCT04453722|141518637|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test.|Median Difference (Final Values)|-0.1||||0.307|TWO_SIDED|95.0|-0.2|0.0|||Wilcoxon (Mann-Whitney)|||variable: Post-discharge TWA SpO2 \<90% (%)||0|-0.2|0.307
71005123|NCT04453722|141518637|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test.|Median Difference (Final Values)|-35.0||||0.431|TWO_SIDED|95.0|-195.0|67.0|||Wilcoxon (Mann-Whitney)|||variable: Post-discharge AUC SpO2 \<90% (% \* min)||67|-195|0.431
71044701|NCT02377921|141598490|SUPERIORITY||LS Mean Difference|-1.4||||0.2241|TWO_SIDED|95.0|-3.66|0.86||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference: Ace-ER - placebo|||0.86|-3.66|0.2241
71044702|NCT02377921|141598491|OTHER||LS Mean Difference|-0.32||||0.5608|TWO_SIDED|95.0|-1.39|0.75||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference: Ace-ER 6 g/day - placebo|||0.75|-1.39|0.5608
71044703|NCT04184999|141598533|SUPERIORITY||F-Statistic|207.4|||<|0.01|TWO_SIDED||||||ANOVA|||||||<.01
71044704|NCT02985879|141598544|SUPERIORITY|The primary efficacy analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.34|=|0.998|TWO_SIDED|95.0|-2.63|2.63|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||2.63|-2.63|=0.998
71044705|NCT02985879|141598544|SUPERIORITY|The primary efficacy analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.32|=|0.464|TWO_SIDED|95.0|-1.63|3.58|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||3.58|-1.63|=0.464
71044706|NCT02985879|141598546|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.88|=|0.812|TWO_SIDED|95.0|-1.52|1.93|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||1.93|-1.52|=0.812
71044707|NCT02985879|141598546|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.88|=|0.104|TWO_SIDED|95.0|-0.3|3.16|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||3.16|-0.30|=0.104
71044708|NCT02985879|141598547|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.16|=|0.756|TWO_SIDED|95.0|-0.36|0.26|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||0.26|-0.36|=0.756
71101660|NCT04250207|141711173|SUPERIORITY|||||||0.0019|||||||Wilcoxon Rank Sum Test|||Week 7||||0.0019
71101661|NCT04250207|141711173|SUPERIORITY|||||||0.017|||||||Wilcoxon Rank Sum Test|||Week 9||||0.0170
71101662|NCT04250207|141711173|SUPERIORITY|||||||0.0021|||||||Wilcoxon Rank Sum Test|||Week 9||||0.0021
71101663|NCT04250207|141711173|SUPERIORITY|||||||0.0127|||||||Wilcoxon Rank Sum Test|||Week 12||||0.0127
71101664|NCT04250207|141711173|SUPERIORITY|||||||0.0014|||||||Wilcoxon Rank Sum Test|||Week 12||||0.0014
71101665|NCT04250207|141711173|SUPERIORITY|||||||0.0677|||||||Wilcoxon Rank Sum Test|||Week 16||||0.0677
71005124|NCT04453722|141518638|SUPERIORITY||Risk Ratio (RR)|0.96|||>|0.99|TWO_SIDED|95.0|0.22|4.27|||Fisher Exact|||variable: In hospital Any event, N (%)c||4.27|0.22|>0.99
71005125|NCT04453722|141518638|SUPERIORITY||Risk Ratio (RR)|1.0|||>|0.99|TWO_SIDED|95.0|0.35|2.9|||Chi-squared|||variable: Post-discharge Any event, N (%)||2.90|0.35|>0.99
71044709|NCT02985879|141598547|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.16|=|0.409|TWO_SIDED|95.0|-0.44|0.18|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||0.18|-0.44|=0.409
71101666|NCT04250207|141711173|SUPERIORITY|||||||0.0243|||||||Wilcoxon Rank Sum Test|||Week 16||||0.0243
71101667|NCT04250207|141711173|SUPERIORITY|||||||0.1867|||||||Wilcoxon Rank Sum Test|||Week 20||||0.1867
71101668|NCT04250207|141711173|SUPERIORITY|||||||0.025|||||||Wilcoxon Rank Sum Test|||Week 20||||0.0250
71101669|NCT04250207|141711173|SUPERIORITY|||||||0.3213|||||||Wilcoxon Rank Sum Test|||Week 24||||0.3213
71101670|NCT04250207|141711173|SUPERIORITY|||||||0.0298|||||||Wilcoxon Rank Sum Test|||Week 24||||0.0298
71101671|NCT04250207|141711173|SUPERIORITY|||||||0.1449|||||||Wilcoxon Rank Sum Test|||Week 38||||0.1449
71101672|NCT04250207|141711173|SUPERIORITY|||||||0.0947|||||||Wilcoxon Rank Sum Test|||Week 38||||0.0947
71101673|NCT04250207|141711173|SUPERIORITY|||||||0.5181|||||||Wilcoxon Rank Sum Test|||Week 52||||0.5181
71101674|NCT04250207|141711173|SUPERIORITY|||||||0.1898|||||||Wilcoxon Rank Sum Test|||Week 52||||0.1898
71101675|NCT04250207|141711174|SUPERIORITY|||||||0.0021|||||||Log Rank|||||||0.0021
71044710|NCT02985879|141598548|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|13.54|=|0.597|TWO_SIDED|95.0|-33.86|19.53|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||19.53|-33.86|=0.597
71044711|NCT02985879|141598548|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|13.56|=|0.642|TWO_SIDED|95.0|-33.04|20.42|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||20.42|-33.04|=0.642
71044712|NCT02985879|141598549|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|2.53|=|0.323|TWO_SIDED|95.0|-2.48|7.51|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||7.51|-2.48|=0.323
71044713|NCT02985879|141598549|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|2.51|=|0.974|TWO_SIDED|95.0|-4.86|5.02|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||5.02|-4.86|=0.974
71101676|NCT04250207|141711174|SUPERIORITY|||||||0.1696|||||||Log Rank|||||||0.1696
71101677|NCT04250207|141711175|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4872|||||||Chi-square or Fisher exact|||Week 5||||0.4872
71101678|NCT04250207|141711175|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4634|||||||Chi-square or Fisher exact|||Week 5||||0.4634
71101679|NCT04250207|141711175|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.605|||||||Chi-square or Fisher exact|||Week 7||||0.6050
71101680|NCT04250207|141711175|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4762|||||||Chi-square or Fisher exact|||Week 7||||0.4762
71101681|NCT04250207|141711175|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||>|0.9999|||||||Chi-square or Fisher exact|||Week 9||||> 0.9999
71101682|NCT04250207|141711175|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||>|0.9999|||||||Chi-square or Fisher exact|||Week 9||||> 0.9999
71101683|NCT04250207|141711175|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4227|||||||Chi-square or Fisher exact|||Week 12||||0.4227
71101684|NCT04250207|141711175|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.6796|||||||Chi-square or Fisher exact|||Week 12||||0.6796
71101685|NCT04250207|141711175|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4642|||||||Chi-square or Fisher exact|||Week 16||||0.4642
71101686|NCT04250207|141711175|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4645|||||||Chi-square or Fisher exact|||Week 16||||0.4645
71101687|NCT04250207|141711175|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.2744|||||||Chi-square or Fisher exact|||Week 20||||0.2744
71101688|NCT04250207|141711175|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.7026|||||||Chi-square or Fisher exact|||Week 20||||0.7026
71101689|NCT04250207|141711175|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.7817|||||||Chi-square or Fisher exact|||Week 24||||0.7817
71101690|NCT04250207|141711175|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.9285|||||||Chi-square or Fisher exact|||Week 24||||0.9285
71101691|NCT04250207|141711175|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0135|||||||Chi-square or Fisher exact|||Week 38||||0.0135
71101692|NCT04250207|141711175|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.6992|||||||Chi-square or Fisher exact|||Week 38||||0.6992
71101693|NCT04250207|141711175|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0135|||||||Chi-square or Fisher exact|||Week 52||||0.0135
71101694|NCT04250207|141711175|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.5154|||||||Chi-square or Fisher exact|||Week 52||||0.5154
71101695|NCT04250207|141711176|SUPERIORITY|||||||0.1209|||||||Log Rank|||||||0.1209
71101696|NCT04250207|141711176|SUPERIORITY|||||||0.7116|||||||Log Rank|||||||0.7116
71101697|NCT04250207|141711177|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0915|||||||Chi-square or Fisher exact|||Week 3||||0.0915
71101698|NCT04250207|141711177|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.3282|||||||Chi-square or Fisher exact|||Week 3||||0.3282
71101699|NCT04250207|141711177|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0648|||||||Chi-square or Fisher exact|||Week 5||||0.0648
71101700|NCT04250207|141711177|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.031|||||||Chi-square or Fisher exact|||Week 5||||0.0310
71101701|NCT04250207|141711177|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0187|||||||Chi-square or Fisher exact|||Week 7||||0.0187
70925263|NCT04169373|141343681|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.14|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.68|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-0.68|-1.60|<0.0001
71101702|NCT04250207|141711177|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0036|||||||Chi-square or Fisher exact|||Week 7||||0.0036
71101703|NCT04250207|141711177|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0687|||||||Chi-square or Fisher exact|||Week 9||||0.0687
70925264|NCT04169373|141343682|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-2.23|||<|0.0001|TWO_SIDED|95.0|-3.26|-1.21|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-1.21|-3.26|<0.0001
70925265|NCT04169373|141343683|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.78|||<|0.0001|TWO_SIDED|95.0|-2.56|-1.0|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-1.00|-2.56|<0.0001
70925266|NCT04169373|141343684|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|22.8|||<|0.0001|TWO_SIDED|95.0|12.2|33.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||33.4|12.2|<0.0001
70925267|NCT04169373|141343684|OTHER||Odds Ratio (OR)|2.5|||||TWO_SIDED|95.0|1.6|4.0|||||Upadacitinib : Placebo|A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.||4.0|1.6|
70925268|NCT04169373|141343685|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-0.1||||0.1781|TWO_SIDED|95.0|-0.25|0.05|||ANCOVA|ANCOVA model including treatment and main stratification factor MRI and hsCRP status as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||0.05|-0.25|0.1781
70925269|NCT04169373|141343686|OTHER||LS Mean Difference|-0.7||||0.0193|TWO_SIDED|95.0|-1.3|-0.1|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-0.1|-1.3|0.0193
70925270|NCT04169373|141343687|SUPERIORITY||Response Rate Difference|20.1||||0.0003|TWO_SIDED|95.0|9.3|30.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||30.9|9.3|0.0003
70925271|NCT04169373|141343688|OTHER||LS Mean Difference|-1.13||||0.0206|TWO_SIDED|95.0|-2.08|-0.17||This comparison was not part of the pre-specified multiplicity testing sequence.|ANCOVA|ANCOVA model including treatment and main stratification factors MRI and hsCRP status as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-0.17|-2.08|0.0206
70925272|NCT04169373|141343690|SUPERIORITY||Response Rate Difference|17.6||||0.0004|TWO_SIDED|95.0|7.9|27.3||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||27.3|7.9|0.0004
70925273|NCT04169373|141343691|SUPERIORITY||Response Rate Difference|21.9|||<|0.0001|TWO_SIDED|95.0|13.2|30.6||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||30.6|13.2|<0.0001
70925274|NCT04169373|141343692|SUPERIORITY||Response Rate Difference|23.1|||<|0.0001|TWO_SIDED|95.0|12.4|33.7||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||33.7|12.4|<0.0001
70925275|NCT01333969|141343693|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.043|TWO_SIDED|95.0|-1.4|-0.02|||GEE|Regression analysis using the generalized estimating equations (GEE) method to compare the changes over time in VAS scores at rest and with exercise||||-0.02|-1.40|.043
70925276|NCT01333969|141343694|OTHER||Mean Difference (Final Values)|0.043||||0.043|TWO_SIDED||||||t-test, 2 sided|||||||.043
71101704|NCT04250207|141711177|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0016|||||||Chi-square or Fisher exact|||Week 9||||0.0016
71005126|NCT04453722|141518639|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test.|Median Difference (Final Values)|-6.0||||0.354|TWO_SIDED|95.0|-26.0|4.0|||Wilcoxon (Mann-Whitney)|||variable: In hospital Number||4.0|-26.0|0.354
71005127|NCT04453722|141518639|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test.|Median Difference (Final Values)|-46.1||||0.133|TWO_SIDED|95.0|-274.0|5.1|||Wilcoxon (Mann-Whitney)|||variable: In hospital Total duration (min)||5.1|-274|0.133
71005128|NCT04453722|141518639|SUPERIORITY||Median Difference (Final Values)|-24.1||||0.075|TWO_SIDED|95.0|-213.0|0.1|||Wilcoxon (Mann-Whitney)|||variable: In hospital Duration \>2 min (min)||0.1|-213|0.075
71005129|NCT04453722|141518639|SUPERIORITY||Median Difference (Final Values)|-2.0||||0.009|TWO_SIDED|95.0|-4.5|-0.4|||Wilcoxon (Mann-Whitney)|||variable: In hospital Mean duration-all patients (min)||-0.4|-4.5|0.009
71005130|NCT04453722|141518639|SUPERIORITY||Median Difference (Final Values)|-2.2||||0.001|TWO_SIDED|95.0|-4.7|-0.7|||Wilcoxon (Mann-Whitney)|||variable: in hospital mean duration for events in those with any events (min)||-0.7|-4.7|0.001
71005131|NCT04453722|141518639|SUPERIORITY||Median Difference (Final Values)|0.0||||0.584|TWO_SIDED|95.0|-4.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: post-discharge number||1.0|-4.0|0.584
71005132|NCT04453722|141518639|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test.|Median Difference (Final Values)|-1.3||||0.556|TWO_SIDED|95.0|-18.6|3.3|||Wilcoxon (Mann-Whitney)|||variable: Post-discharge duration (min)||3.3|-18.6|0.556
71005133|NCT04453722|141518642|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|1.0||||0.096|TWO_SIDED|95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||variable: Degree of disturbing daily life except sleep (at the day of discharge)||2.0|0.0|0.096
71005134|NCT04453722|141518642|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.205|TWO_SIDED|95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||variable: Degree of disturbing sleep (at the day of discharge)||2.0|0.0|0.205
71005135|NCT04453722|141518642|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.839|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: comfortable to wear (at the day of discharge)||0.0|-1.0|0.839
71005136|NCT04453722|141518642|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.621|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Tolerable to audible alert (at the day of discharge)||0.0|0.0|0.621
71005137|NCT04453722|141518642|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.898|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: Tolerable to tactile alert||1.0|-1.0|0.898
71005138|NCT04453722|141518642|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.654|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: easily cleaned/disinfected (at the day of discharge)||0.0|0.0|0.654
71044714|NCT02985879|141598554|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.14|=|0.761|TWO_SIDED|95.0|-0.31|0.23|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||0.23|-0.31|=0.761
71101705|NCT04250207|141711177|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0218|||||||Chi-square or Fisher exact|||Week 12||||0.0218
71005139|NCT04453722|141518642|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.929|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: adequate battery life (at the day of discharge)||1.0|-1.0|0.929
71005140|NCT04453722|141518642|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.2|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Satisfy with the electrode patch (at the day of discharge)||0.0|-1.0|0.200
71005141|NCT04453722|141518642|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.987|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Willing to use after study (at the day of discharge)||0.0|0.0|0.987
71005142|NCT04453722|141518642|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.581|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Disturb IV line (at the day of discharge)||0.0|-1.0|0.581
71005143|NCT04453722|141518642|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|1.0||||0.18|TWO_SIDED|95.0|0.0|3.0|||Wilcoxon (Mann-Whitney)|||variable: Degree of disturbing daily life except sleep (after 24 hours of discharge)||3.0|0.0|0.180
71101706|NCT04250207|141711177|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0013|||||||Chi-square or Fisher exact|||Week 12||||0.0013
71101707|NCT04250207|141711177|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0348|||||||Chi-square or Fisher exact|||Week 16||||0.0348
71101708|NCT04250207|141711177|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.1028|||||||Chi-square or Fisher exact|||Week 16||||0.1028
71101709|NCT04250207|141711177|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.8677|||||||Chi-square or Fisher exact|||Week 20||||0.8677
71101710|NCT04250207|141711177|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4401|||||||Chi-square or Fisher exact|||Week 20||||0.4401
71101711|NCT04250207|141711177|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.5926|||||||Chi-square or Fisher exact|||Week 24||||0.5926
71101712|NCT04250207|141711177|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0732|||||||Chi-square or Fisher exact|||Week 24||||0.0732
71101713|NCT04250207|141711177|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.2497|||||||Chi-square or Fisher exact|||Week 38||||0.2497
71101714|NCT04250207|141711177|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.2453|||||||Chi-square or Fisher exact|||Week 38||||0.2453
71101715|NCT04250207|141711177|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||>|0.9999|||||||Chi-square or Fisher exact|||Week 52||||> 0.9999
71101716|NCT04250207|141711177|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||>|0.9999|||||||Chi-square or Fisher exact|||Week 52||||> 0.9999
70925277|NCT01333969|141343695|SUPERIORITY||Mean Difference (Final Values)|0.584||||0.584|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.584
71101717|NCT04250207|141711178|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0093|||||||Chi-square or Fisher exact|||Week 3||||0.0093
71101718|NCT04250207|141711178|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||>|0.9999|||||||Chi-square or Fisher exact|||Week 3||||> 0.9999
71005144|NCT04453722|141518642|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|1.0||||0.171|TWO_SIDED|95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||variable: degree of distributing sleep (after 24 hours of discharge)||2.0|0.0|0.171
71101719|NCT04250207|141711178|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0006|||||||Chi-square or Fisher exact|||Week 5||||0.0006
71101720|NCT04250207|141711178|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.3449|||||||Chi-square or Fisher exact|||Week 5||||0.3449
71005145|NCT04453722|141518642|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.074|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Tolerable to audible alert (after 24 hours of discharge)||0.0|-1.0|0.074
71005146|NCT04453722|141518642|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.414|TWO_SIDED|95.0|-2.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: Tolerable to tactile alert (after 24 hours of discharge)||1.0|-2.0|0.414
71005147|NCT04453722|141518642|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.506|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Easily cleaned/disinfected (after 24 hours of discharge)||0.0|0.0|0.506
71005148|NCT04453722|141518642|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.747|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Adequate battery life (after 24 hours of discharge)||0.0|-1.0|0.747
71005149|NCT04453722|141518642|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|-1.0||||0.023|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: satisfy with the electrode patch (after 24 hours of discharge)||0.0|-2.0|0.023
71005150|NCT04453722|141518642|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.023|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Willing to use after study (after 24 hours of discharge)||0.0|-1.0|0.023
71005151|NCT04453722|141518643|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.73|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||Degree of disturbing routine work||0.0|-1.0|0.73
71005152|NCT04453722|141518643|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.097|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||Easily cleaned/disinfected||1.0|0.0|0.097
71005153|NCT04453722|141518643|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|1.0||||0.02|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: Adequate battery life||1.0|0.0|0.02
71005154|NCT04453722|141518643|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.037|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: Satisfy with the electrode patch||1.0|0.0|0.037
71005155|NCT04453722|141518643|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.482|TWO_SIDED|95.0|-2.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: Tolerable to audible alert||1.0|-2.0|0.482
71005156|NCT04453722|141518643|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.031|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: Willing to use after study||1.0|0.0|0.031
71005157|NCT04453722|141518643|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.947|TWO_SIDED|95.0|0.0|1.0||variable: Patients' complaint about the device|Wilcoxon (Mann-Whitney)|||variable: Patients' complaint about the device||1.0|0.0|0.947
71005158|NCT04453722|141518643|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.324|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Disturb IV line||0.0|0.0|0.324
71101721|NCT04250207|141711178|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0028|||||||Chi-square or Fisher exact|||Week 7||||0.0028
70925278|NCT01333969|141343696|SUPERIORITY||Mean Difference (Final Values)|0.763||||0.763|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.763
70925279|NCT01333969|141343697|SUPERIORITY||Mean Difference (Final Values)|0.602||||0.602|TWO_SIDED||||||GEE|Regression analyses based on the generalized estimating equations (GEE) method||||||.602
70925280|NCT01333969|141343698|SUPERIORITY||Mean Difference (Final Values)|0.8656||||0.8656|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.8656
70925281|NCT01333969|141343699|SUPERIORITY||Mean Difference (Final Values)|0.8422||||0.8422|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.8422
70925282|NCT01333969|141343700|SUPERIORITY||Mean Difference (Final Values)|0.526||||0.526|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.526
70925283|NCT01333969|141343701|SUPERIORITY||Mean Difference (Final Values)|0.526||||0.526|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.526
70925284|NCT01999075|141343702|SUPERIORITY||Mean Difference (Net)|1.9||||0.68|TWO_SIDED|95.0|-6.9|10.7||The a priori threshold for statistical significance was a two-sided p-value of 0.05.|ANCOVA||"The mean difference between the intervention and the control group in the change from baseline to 2 years was estimated.~Estimates presented here are based on multiple imputation of missing values."|||10.7|-6.9|0.68
70925285|NCT01999075|141343706|SUPERIORITY||Mean Difference (Net)|0.27|||||TWO_SIDED|95.0|-1.92|2.18||||||Difference in change in peak cough flow (L/min) from baseline to 2 years, between conventional treatment and intervention group.||2.18|-1.92|
70925286|NCT01999075|141343707|SUPERIORITY|||||||0.79|||||||Mixed Models Analysis|||||||0.79
71005159|NCT01263470|141518644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||||TWO_SIDED|95.0|-0.755|-0.386||||||||-0.386|-0.755|
70925287|NCT01999075|141343708|SUPERIORITY|||||||1|||||||Mixed Models Analysis|||||||1.00
71005160|NCT01263470|141518644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.762|||||TWO_SIDED|95.0|-0.925|-0.598||||||||-0.598|-0.925|
70925288|NCT01999075|141343709|SUPERIORITY|||||||0.98|||||||Mixed Models Analysis|||||||0.98
70925289|NCT05081583|141343712|OTHER||AUC ratio (geometric mean)|0.88|||||TWO_SIDED|90.0|0.82|0.96||||||The predefined no effect range was 0.80-1.25; that is, if the geometric mean ratio lay outside this range, a pharmacokinetic interaction was evident.||0.96|0.82|
71005161|NCT01263470|141518644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.826|||||TWO_SIDED|95.0|-0.987|-0.665||||||||-0.665|-0.987|
71005162|NCT01263470|141518644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.887|||||TWO_SIDED|95.0|-1.035|-0.739||||||||-0.739|-1.035|
70925290|NCT05081583|141343713|OTHER|The predefined no effect range was 0.80-1.25; that is, if the geometric mean ratio lay outside this range, a pharmacokinetic interaction was evident.|Cmax ratio (geometric mean)|0.93|||||TWO_SIDED|90.0|0.85|1.01||||||||1.01|0.85|
70925291|NCT05081583|141343714|OTHER||Half-life ratio (geometric mean)|1.01|||||TWO_SIDED|90.0|0.93|1.07||||||||1.07|0.93|
70925292|NCT05081583|141343715|OTHER||Renal clearance ratio (geometric mean)|0.97|||||TWO_SIDED|90.0|0.84|1.12||||||||1.12|0.84|
70925293|NCT05081583|141343716|OTHER||AUC ratio (geometric mean)|0.97|||||TWO_SIDED|90.0|0.81|1.15||||||||1.15|0.81|
70925294|NCT02907099|141343768|OTHER|||||||0.5|||||||t-test, 2 sided|||||||0.5
71005163|NCT01263470|141518644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.351|||||TWO_SIDED|95.0|-0.57|-0.132||||||||-0.132|-0.570|
70925295|NCT02907099|141343769|OTHER|||||||0.5|||||||t-test, 2 sided|||||||0.5
70925296|NCT03675282|141343775|SUPERIORITY||Mean Difference (Final Values)|19.8||||0.66|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 1 (Baseline vs. 24 months)||||0.66
70925297|NCT03675282|141343775|SUPERIORITY||Mean Difference (Final Values)|-21.3||||0.63|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 2 (Baseline vs. 24 months)||||0.63
70925298|NCT03675282|141343775|SUPERIORITY||Mean Difference (Final Values)|0.87||||0.99|TWO_SIDED||||||paired t-test|||REM Sleep Behavior Disorder (Baseline vs. 24 months)||||0.99
70925299|NCT03675282|141343775|SUPERIORITY||Mean Difference (Final Values)|11.5||||0.67|TWO_SIDED||||||paired t-test|||Healthy Controls (Baseline vs. 24 months)||||0.67
70925300|NCT03675282|141343776|SUPERIORITY||Mean Difference (Final Values)|-0.625||||0.4|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 1 UPDRS Part I (Baseline vs. 24 months)||||0.40
70925301|NCT03675282|141343776|SUPERIORITY||Mean Difference (Final Values)|-1.453||||0.4|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 1 UPDRS Part II (Baseline vs. 24 months)||||0.40
70925302|NCT03675282|141343776|SUPERIORITY||Mean Difference (Final Values)|-6.15||||0.04|TWO_SIDED|||||Parkinson Disease - Stage 1 UPDRS Part III (Baseline vs. 24 months)|paired t-test|||||||0.04
70925303|NCT03675282|141343776|SUPERIORITY||Mean Difference (Final Values)|-0.056||||0.94|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 1 UPDRS Part IV (Baseline vs. 24 months)||||0.94
71005164|NCT01263470|141518644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.542|||||TWO_SIDED|95.0|-0.743|-0.342||||||||-0.342|-0.743|
71005165|NCT01263470|141518644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.607|||||TWO_SIDED|95.0|-0.808|-0.406||||||||-0.406|-0.808|
71005166|NCT01263470|141518644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.667|||||TWO_SIDED|95.0|-0.859|-0.475||||||||-0.475|-0.859|
71005167|NCT01263470|141518645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.158|||||TWO_SIDED|95.0|-0.213|-0.104||||||||-0.104|-0.213|
71005168|NCT01263470|141518645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.174|||||TWO_SIDED|95.0|-0.234|-0.114||||||||-0.114|-0.234|
71005169|NCT01263470|141518645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|||||TWO_SIDED|95.0|-0.219|-0.1||||||||-0.100|-0.219|
71005170|NCT01263470|141518645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.153|||||TWO_SIDED|95.0|-0.212|-0.095||||||||-0.095|-0.212|
71005171|NCT01263470|141518645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.059|||||TWO_SIDED|95.0|-0.116|-0.003||||||||-0.003|-0.116|
71005172|NCT01263470|141518645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.075|||||TWO_SIDED|95.0|-0.136|-0.014||||||||-0.014|-0.136|
71005173|NCT01263470|141518645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.061|||||TWO_SIDED|95.0|-0.121|0.0||||||||0.000|-0.121|
71005174|NCT01263470|141518645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|||||TWO_SIDED|95.0|-0.114|0.006||||||||0.006|-0.114|
71005175|NCT01263470|141518646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.326|||||TWO_SIDED|95.0|-0.419|-0.233||||||||-0.233|-0.419|
71044715|NCT02985879|141598554|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13|=|0.678|TWO_SIDED|95.0|-0.32|0.21|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||0.21|-0.32|=0.678
71005176|NCT01263470|141518646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.369|||||TWO_SIDED|95.0|-0.47|-0.268||||||||-0.268|-0.470|
71005177|NCT01263470|141518646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||||TWO_SIDED|95.0|-0.438|-0.241||||||||-0.241|-0.438|
71005178|NCT01263470|141518646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.387|||||TWO_SIDED|95.0|-0.485|-0.288||||||||-0.288|-0.485|
71005179|NCT01263470|141518646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.178|||||TWO_SIDED|95.0|-0.28|-0.076||||||||-0.076|-0.280|
71005180|NCT01263470|141518646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.221|||||TWO_SIDED|95.0|-0.329|-0.112||||||||-0.112|-0.329|
71005181|NCT01263470|141518646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.192|||||TWO_SIDED|95.0|-0.299|-0.085||||||||-0.085|-0.299|
71005182|NCT01263470|141518646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.239|||||TWO_SIDED|95.0|-0.346|-0.131||||||||-0.131|-0.346|
71005183|NCT01263470|141518647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-0.644|-0.356||||||||-0.356|-0.644|
71005184|NCT01263470|141518647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.614|||||TWO_SIDED|95.0|-0.763|-0.464||||||||-0.464|-0.763|
71005185|NCT01263470|141518647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-0.804|-0.516||||||||-0.516|-0.804|
71005186|NCT01263470|141518647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.695|||||TWO_SIDED|95.0|-0.832|-0.559||||||||-0.559|-0.832|
71005187|NCT01263470|141518647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.325|||||TWO_SIDED|95.0|-0.494|-0.156||||||||-0.156|-0.494|
71005188|NCT01263470|141518647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.438|||||TWO_SIDED|95.0|-0.61|-0.267||||||||-0.267|-0.610|
71005189|NCT01263470|141518647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.485|||||TWO_SIDED|95.0|-0.654|-0.315||||||||-0.315|-0.654|
71005190|NCT01263470|141518647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|||||TWO_SIDED|95.0|-0.683|-0.357||||||||-0.357|-0.683|
71005191|NCT01263470|141518648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.6|||||TWO_SIDED|95.0|-23.27|-7.93||||||||-7.93|-23.27|
71005192|NCT01263470|141518648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.69|||||TWO_SIDED|95.0|-25.34|-10.05||||||||-10.05|-25.34|
71005193|NCT01263470|141518648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.08|||||TWO_SIDED|95.0|-24.14|-8.02||||||||-8.02|-24.14|
71005194|NCT01263470|141518648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.47|||||TWO_SIDED|95.0|-32.06|-14.89||||||||-14.89|-32.06|
71005195|NCT01263470|141518648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.82|||||TWO_SIDED|95.0|-12.66|1.02||||||||1.02|-12.66|
71005196|NCT01263470|141518648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.92|||||TWO_SIDED|95.0|-14.76|-1.08||||||||-1.08|-14.76|
71005197|NCT01263470|141518648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|||||TWO_SIDED|95.0|-13.53|0.93||||||||0.93|-13.53|
71005198|NCT01263470|141518648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.69|||||TWO_SIDED|95.0|-21.45|-5.94||||||||-5.94|-21.45|
71044716|NCT02985879|141598555|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|2.3|=|0.653|TWO_SIDED|95.0|-3.5|5.57|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||5.57|-3.50|=0.653
71005199|NCT01263470|141518649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.6|||||TWO_SIDED|95.0|-23.27|-7.93||||||||-7.93|-23.27|
71005200|NCT01263470|141518649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.69|||||TWO_SIDED|95.0|-25.34|-10.05||||||||-10.05|-25.34|
71005201|NCT01263470|141518649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.08|||||TWO_SIDED|95.0|-24.14|-8.02||||||||-8.02|-24.14|
71005202|NCT01263470|141518649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.47|||||TWO_SIDED|95.0|-32.06|-14.89||||||||-14.89|-32.06|
71005203|NCT01263470|141518649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.82|||||TWO_SIDED|95.0|-12.66|1.02||||||||1.02|-12.66|
71005204|NCT01263470|141518649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.92|||||TWO_SIDED|95.0|-14.76|-1.08||||||||-1.08|-14.76|
71005205|NCT01263470|141518649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|||||TWO_SIDED|95.0|-13.53|0.93||||||||0.93|-13.53|
71005206|NCT01263470|141518649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.69|||||TWO_SIDED|95.0|-21.45|-5.94||||||||-5.94|-21.45|
71005207|NCT01263470|141518650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.73|||||TWO_SIDED|95.0|-26.52|-8.94||||||||-8.94|-26.52|
71005208|NCT01263470|141518650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.22|||||TWO_SIDED|95.0|-32.07|-16.37||||||||-16.37|-32.07|
71005209|NCT01263470|141518650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.34|||||TWO_SIDED|95.0|-32.03|-16.65||||||||-16.65|-32.03|
71005210|NCT01263470|141518650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.28|||||TWO_SIDED|95.0|-37.04|-19.52||||||||-19.52|-37.04|
71005211|NCT01263470|141518650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.55|||||TWO_SIDED|95.0|-17.28|0.18||||||||0.18|-17.28|
71005212|NCT01263470|141518650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.04|||||TWO_SIDED|95.0|-22.9|-7.18||||||||-7.18|-22.90|
71005213|NCT01263470|141518650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.16|||||TWO_SIDED|95.0|-22.9|-7.42||||||||-7.42|-22.90|
71005214|NCT01263470|141518650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.1|||||TWO_SIDED|95.0|-27.8|-10.4||||||||-10.40|-27.80|
71005215|NCT01263470|141518651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.92|||||TWO_SIDED|95.0|-24.19|-5.64||||||||-5.64|-24.19|
71005216|NCT01263470|141518651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.17|||||TWO_SIDED|95.0|-27.86|-12.48||||||||-12.48|-27.86|
71005217|NCT01263470|141518651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.07|||||TWO_SIDED|95.0|-30.41|-15.73||||||||-15.73|-30.41|
71005218|NCT01263470|141518651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.17|||||TWO_SIDED|95.0|-36.05|-20.29||||||||-20.29|-36.05|
71005219|NCT01263470|141518651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.27|||||TWO_SIDED|95.0|-15.6|3.06||||||||3.06|-15.60|
71005220|NCT01263470|141518651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.52|||||TWO_SIDED|95.0|-19.41|-3.64||||||||-3.64|-19.41|
71005221|NCT01263470|141518651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.42|||||TWO_SIDED|95.0|-22.04|-6.8||||||||-6.80|-22.04|
71005222|NCT01263470|141518651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.52|||||TWO_SIDED|95.0|-27.61|-11.43||||||||-11.43|-27.61|
71005223|NCT01263470|141518652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.145|||||TWO_SIDED|95.0|-0.384|0.094||||||||0.094|-0.384|
71005224|NCT01263470|141518652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|||||TWO_SIDED|95.0|-0.106|0.374||||||||0.374|-0.106|
71005225|NCT01263470|141518652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|||||TWO_SIDED|95.0|-0.103|0.39||||||||0.390|-0.103|
71005226|NCT01263470|141518652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|||||TWO_SIDED|95.0|-0.218|0.227||||||||0.227|-0.218|
71005227|NCT01263470|141518652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.002|||||TWO_SIDED|95.0|-0.241|0.245||||||||0.245|-0.241|
71005228|NCT01263470|141518652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.281|||||TWO_SIDED|95.0|0.038|0.524||||||||0.524|0.038|
71005229|NCT01263470|141518652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.291|||||TWO_SIDED|95.0|0.041|0.54||||||||0.540|0.041|
71005230|NCT01263470|141518652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|||||TWO_SIDED|95.0|-0.077|0.38||||||||0.380|-0.077|
71005231|NCT01263470|141518653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|||||TWO_SIDED|95.0|-0.245|0.156||||||||0.156|-0.245|
71005232|NCT01263470|141518653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|||||TWO_SIDED|95.0|-0.185|0.21||||||||0.210|-0.185|
71005233|NCT01263470|141518653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|||||TWO_SIDED|95.0|-0.053|0.369||||||||0.369|-0.053|
71005234|NCT01263470|141518653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|||||TWO_SIDED|95.0|-0.14|0.235||||||||0.235|-0.140|
71005235|NCT01263470|141518653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.122|||||TWO_SIDED|95.0|-0.097|0.341||||||||0.341|-0.097|
71044717|NCT02985879|141598555|SUPERIORITY|The primary efficacy analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|2.3|=|0.748|TWO_SIDED|95.0|-3.5|5.57|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||5.57|-3.50|=0.748
70925304|NCT03675282|141343776|SUPERIORITY||Mean Difference (Final Values)|-0.414||||0.53|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 2 UPDRS Part I (Baseline vs. 24 months)||||0.53
71005236|NCT01263470|141518653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.179|||||TWO_SIDED|95.0|-0.036|0.395||||||||0.395|-0.036|
71005237|NCT01263470|141518653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.325|||||TWO_SIDED|95.0|0.097|0.553||||||||0.553|0.097|
71005238|NCT01263470|141518653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215|||||TWO_SIDED|95.0|0.006|0.423||||||||0.423|0.006|
71005239|NCT01263470|141518654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.117|||||TWO_SIDED|95.0|-0.444|0.209||||||||0.209|-0.444|
70925305|NCT03675282|141343776|SUPERIORITY||Mean Difference (Final Values)|-1.779||||0.38|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 2 UPDRS Part II (Baseline vs. 24 months)||||0.38
71005240|NCT01263470|141518654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.362|0.162||||||||0.162|-0.362|
71005241|NCT01263470|141518654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|||||TWO_SIDED|95.0|-0.166|0.324||||||||0.324|-0.166|
71005242|NCT01263470|141518654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.117|||||TWO_SIDED|95.0|-0.355|0.121||||||||0.121|-0.355|
71005243|NCT01263470|141518654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|||||TWO_SIDED|95.0|-0.203|0.408||||||||0.408|-0.203|
71005244|NCT01263470|141518654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.124|0.364||||||||0.364|-0.124|
71005245|NCT01263470|141518654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.299|||||TWO_SIDED|95.0|0.071|0.526||||||||0.526|0.071|
71005246|NCT01263470|141518654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|||||TWO_SIDED|95.0|-0.118|0.322||||||||0.322|-0.118|
71005247|NCT01263470|141518655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|||||TWO_SIDED|95.0|-0.23|0.308||||||||0.308|-0.230|
71005248|NCT01263470|141518655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|||||TWO_SIDED|95.0|-0.029|0.379||||||||0.379|-0.029|
71005249|NCT01263470|141518655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.248|||||TWO_SIDED|95.0|0.044|0.453||||||||0.453|0.044|
71005250|NCT01263470|141518655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|||||TWO_SIDED|95.0|-0.035|0.407||||||||0.407|-0.035|
71005251|NCT01263470|141518655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|||||TWO_SIDED|95.0|-0.236|0.34||||||||0.340|-0.236|
71005252|NCT01263470|141518655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|||||TWO_SIDED|95.0|-0.044|0.421||||||||0.421|-0.044|
71005253|NCT01263470|141518655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.261|||||TWO_SIDED|95.0|0.026|0.496||||||||0.496|0.026|
71005254|NCT01263470|141518655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.199|||||TWO_SIDED|95.0|-0.049|0.448||||||||0.448|-0.049|
71005255|NCT01263470|141518656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.85|||||TWO_SIDED|95.0|-38.75|-8.94||||||||-8.94|-38.75|
71005256|NCT01263470|141518656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.38|||||TWO_SIDED|95.0|-37.14|-9.61||||||||-9.61|-37.14|
71005257|NCT01263470|141518656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.6|||||TWO_SIDED|95.0|-53.18|-28.02||||||||-28.02|-53.18|
71005258|NCT01263470|141518656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.75|||||TWO_SIDED|95.0|-54.93|-30.58||||||||-30.58|-54.93|
71005259|NCT01263470|141518656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.36|||||TWO_SIDED|95.0|-19.7|8.98||||||||8.98|-19.70|
71005260|NCT01263470|141518656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.89|||||TWO_SIDED|95.0|-18.13|8.35||||||||8.35|-18.13|
71005261|NCT01263470|141518656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.11|||||TWO_SIDED|95.0|-34.22|-10.01||||||||-10.01|-34.22|
71005262|NCT01263470|141518656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.27|||||TWO_SIDED|95.0|-35.98|-12.55||||||||-12.55|-35.98|
71005263|NCT01263470|141518657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-58.31|||||TWO_SIDED|95.0|-80.79|-35.83||||||||-35.83|-80.79|
71005264|NCT01263470|141518657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-60.66|||||TWO_SIDED|95.0|-80.84|-40.47||||||||-40.47|-80.84|
71005265|NCT01263470|141518657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-78.72|||||TWO_SIDED|95.0|-97.03|-60.4||||||||-60.40|-97.03|
71005266|NCT01263470|141518657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-87.43|||||TWO_SIDED|95.0|-106.26|-68.6||||||||-68.60|-106.26|
70925306|NCT03675282|141343776|SUPERIORITY||Mean Difference (Final Values)|-3.59||||0.24|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 2 UPDRS Part III (Baseline vs. 24 months)||||0.24
70925307|NCT03675282|141343776|SUPERIORITY||Mean Difference (Final Values)|-0.376||||0.73|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 2 UPDRS Part IV (Baseline vs. 24 months)||||0.73
71005267|NCT01263470|141518657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.73|||||TWO_SIDED|95.0|-24.69|19.23||||||||19.23|-24.69|
71005268|NCT01263470|141518657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.07|||||TWO_SIDED|95.0|-24.85|14.7||||||||14.70|-24.85|
71005269|NCT01263470|141518657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.13|||||TWO_SIDED|95.0|-41.16|-5.11||||||||-5.11|-41.16|
71005270|NCT01263470|141518657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.84|||||TWO_SIDED|95.0|-50.36|-13.33||||||||-13.33|-50.36|
71005271|NCT01263470|141518658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.859|||||TWO_SIDED|95.0|-2.736|8.455||||||||8.455|-2.736|
71005272|NCT01263470|141518658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.456|||||TWO_SIDED|95.0|0.748|10.165||||||||10.165|0.748|
71005273|NCT01263470|141518658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.715|||||TWO_SIDED|95.0|3.181|12.248||||||||12.248|3.181|
71005274|NCT01263470|141518658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.557|||||TWO_SIDED|95.0|-3.763|8.877||||||||8.877|-3.763|
71044718|NCT02985879|141598556|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.34|=|0.828|TWO_SIDED|95.0|-0.6|0.74|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||0.74|-0.60|=0.828
71101722|NCT04250207|141711178|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0028|||||||Chi-square or Fisher exact|||Week 7||||0.0028
71005275|NCT01263470|141518658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.66|||||TWO_SIDED|95.0|7.924|21.396||||||||21.396|7.924|
71005276|NCT01263470|141518658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.257|||||TWO_SIDED|95.0|11.353|23.16||||||||23.160|11.353|
71005277|NCT01263470|141518658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.515|||||TWO_SIDED|95.0|13.629|25.401||||||||25.401|13.629|
71101723|NCT04250207|141711178|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0001|||||||Chi-square or Fisher exact|||Week 9||||0.0001
71005278|NCT01263470|141518658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.357|||||TWO_SIDED|95.0|7.013|21.701||||||||21.701|7.013|
70925308|NCT03675282|141343776|SUPERIORITY||Mean Difference (Final Values)|-1.187||||0.16|TWO_SIDED||||||paired t-test|||REM Sleep Behavior Disorder UPDRS Part I (Baseline vs. 24 months)||||0.16
71005279|NCT01263470|141518659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.535|||||TWO_SIDED|95.0|-0.019|1.089||||||||1.089|-0.019|
71005280|NCT01263470|141518659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.764|||||TWO_SIDED|95.0|0.214|1.315||||||||1.315|0.214|
71005281|NCT01263470|141518659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.999|||||TWO_SIDED|95.0|0.418|1.58||||||||1.580|0.418|
71005282|NCT01263470|141518659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.959|||||TWO_SIDED|95.0|0.43|1.489||||||||1.489|0.430|
71005283|NCT01263470|141518659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.934|||||TWO_SIDED|95.0|0.315|1.552||||||||1.552|0.315|
71005284|NCT01263470|141518659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.163|||||TWO_SIDED|95.0|0.551|1.774||||||||1.774|0.551|
71005285|NCT01263470|141518659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.398|||||TWO_SIDED|95.0|0.759|2.036||||||||2.036|0.759|
71005286|NCT01263470|141518659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.358|||||TWO_SIDED|95.0|0.76|1.956||||||||1.956|0.760|
71005287|NCT01263470|141518660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.25|||||TWO_SIDED|95.0|-7.87|16.38||||||||16.38|-7.87|
71005288|NCT01263470|141518660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.26|||||TWO_SIDED|95.0|-0.9|23.42||||||||23.42|-0.90|
71005289|NCT01263470|141518660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.19|||||TWO_SIDED|95.0|-10.56|16.95||||||||16.95|-10.56|
71005290|NCT01263470|141518660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.66|||||TWO_SIDED|95.0|-16.27|8.94||||||||8.94|-16.27|
71005291|NCT01263470|141518660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.75|||||TWO_SIDED|95.0|-9.79|19.29||||||||19.29|-9.79|
71005292|NCT01263470|141518660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.76|||||TWO_SIDED|95.0|-2.67|26.19||||||||26.19|-2.67|
71005293|NCT01263470|141518660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.69|||||TWO_SIDED|95.0|-12.02|19.4||||||||19.40|-12.02|
71005294|NCT01263470|141518660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.17|||||TWO_SIDED|95.0|-18.04|11.71||||||||11.71|-18.04|
71005295|NCT01327573|141518665|SUPERIORITY_OR_OTHER|||||||0.09||||||"This p-value was for the overall slope difference between groups (i.e. the interaction between group and time).~Significance level was set at 0.1 a priori."|Mixed effects model analysis|||Analysis used eGFR, group, time, and group-by-time variables.||||0.09
71005296|NCT01058395|141518698|SUPERIORITY|"Comparison between groups at 3 months (primary).~Comparison between the 2 tiers."||||||0.021||||||P-value|ANCOVA|Threshold for significance was P-value \< 0.05||DRS levels changes at from 4 weeks to 3 months comparing the different doses.||||0.021
71005297|NCT01058395|141518698|SUPERIORITY|||||||0.258|||||||t-test, 2 sided|||Null hypothesis is that there is no difference between groups in the DRS scores at 3 months.||||0.258
70925309|NCT03675282|141343776|SUPERIORITY||Mean Difference (Final Values)|-0.154||||0.75|TWO_SIDED||||||paired t-test|||REM Sleep Behavior Disorder UPDRS Part II (Baseline vs. 24 months)||||0.75
71005298|NCT01058395|141518698|SUPERIORITY|t-test||||||0.541|||||||t-test, 2 sided|||Null hypothesis is that there is no difference between groups in the DRS scores at 4 weeks.||||0.541
71005299|NCT01058395|141518700|SUPERIORITY||Mean Difference (Final Values)|176.0|||>|0.05|ONE_SIDED||||||t-test, 2 sided|||||||>0.05
71005300|NCT04083781|141518701|SUPERIORITY|Analyses of count endpoints were analysed using a negative binomial regression model with the logarithm of the length of the observation period included (in years) as an offset with randomised treatment regimen, type of haemophilia (HAwI or HBwI) and bleeding frequency (less than 9 or greater than or equal to 9 bleeding episodes during the past 24 weeks prior to screening) as factors comparing arm 1 (on-demand treatment) and arm 2.|Annualised bleeding rate ratio|0.14|||<|0.001|TWO_SIDED|95.0|0.07|0.29|||Two-sided test of no difference from 1|||||0.29|0.07|<0.001
71005301|NCT03733132|141518737|SUPERIORITY|||||||0.854|||||||t-test, 2 sided|||||||0.854
71005302|NCT03733132|141518738|SUPERIORITY|||||||0.389|||||||t-test, 2 sided|||||||0.389
71005303|NCT03733132|141518739|SUPERIORITY|||||||0.609|||||||t-test, 2 sided|||||||0.609
71005304|NCT03733132|141518740|SUPERIORITY|||||||0.371|||||||t-test, 2 sided|||||||0.371
71005305|NCT03733132|141518741|SUPERIORITY|||||||0.686|||||||t-test, 2 sided|||||||0.686
71044719|NCT02985879|141598556|SUPERIORITY|The primary efficacy analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.34|=|0.543|TWO_SIDED|95.0|-0.46|0.87|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||0.87|-0.46|=0.543
70925310|NCT03675282|141343776|SUPERIORITY||Mean Difference (Final Values)|-0.829||||0.28|TWO_SIDED||||||paired t-test|||REM Sleep Behavior Disorder UPDRS Part III (Baseline vs. 24 months)||||0.28
70925311|NCT03675282|141343776|SUPERIORITY||Mean Difference (Final Values)|-0.077||||0.85|TWO_SIDED||||||paired t-test|||REM Sleep Behavior Disorder UPDRS Part IV (Baseline vs. 24 months)||||0.85
71101724|NCT04250207|141711178|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0028|||||||Chi-square or Fisher exact|||Week 9||||0.0028
71005306|NCT05492877|141518756|SUPERIORITY||Hazard Ratio (HR)|1.071||||0.599|TWO_SIDED|90.0|0.869|1.32|||Regression, Cox||||The p-value was based on a 2-sided log rank test stratified by region|1.320|0.869|0.599
71005307|NCT05492877|141518759|SUPERIORITY||Hazard Ratio (HR)|1.234|||||TWO_SIDED|90.0|0.882|1.726|||Regression, Cox|||||1.726|0.882|
71005308|NCT04476108|141518804|SUPERIORITY||Posterior Mean Difference|-0.42|||||TWO_SIDED|95.0|-1.17|0.32|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||0.32|-1.17|
70925312|NCT03675282|141343776|SUPERIORITY||Mean Difference (Final Values)|0.204||||0.78|TWO_SIDED||||||paired t-test|||Healthy Controls UPDRS Part I (Baseline vs. 24 months)||||0.78
71005309|NCT04476108|141518805|SUPERIORITY||Posterior Mean Difference|-0.37|||||TWO_SIDED|95.0|-1.09|0.35|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||0.35|-1.09|
71005310|NCT04476108|141518806|SUPERIORITY||Posterior Mean Difference|-0.27|||||TWO_SIDED|95.0|-0.69|0.15|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||0.15|-0.69|
71005311|NCT04476108|141518807|SUPERIORITY||Posterior Mean Difference|-0.44|||||TWO_SIDED|95.0|-1.2|0.31|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||0.31|-1.20|
71005312|NCT04476108|141518808|SUPERIORITY||Posterior Mean Difference|-2.86|||||TWO_SIDED|95.0|-11.71|6.06|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||6.06|-11.71|
71005313|NCT04476108|141518809|SUPERIORITY||Posterior Mean Difference|0.35|||||TWO_SIDED|95.0|-0.09|0.78|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||0.78|-0.09|
71005314|NCT04476108|141518810|SUPERIORITY||Posterior Mean Difference|0.34|||||TWO_SIDED|95.0|-188.46|187.97|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||187.97|-188.46|
71005315|NCT04476108|141518811|SUPERIORITY||Posterior Mean Difference|0.04|||||TWO_SIDED|95.0|-0.01|0.1|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||0.10|-0.01|
71005316|NCT03676465|141518861|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
71005317|NCT03676465|141518862|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
71005318|NCT03676465|141518863|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
71005319|NCT03676465|141518864|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
71005320|NCT03676465|141518865|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71005321|NCT03676465|141518866|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
71005322|NCT03676465|141518867|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71005323|NCT03676465|141518868|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
71005324|NCT03676465|141518869|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
70925313|NCT03675282|141343776|SUPERIORITY||Mean Difference (Final Values)|-0.381||||0.03|TWO_SIDED||||||paired t-test|||Healthy Controls UPDRS Part IV (Baseline vs. 24 months)||||0.03
71005325|NCT03676465|141518870|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|Wilcoxon (Mann-Whitney)|||||||>0.05
71005326|NCT03676465|141518871|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
71005327|NCT03676465|141518872|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|Wilcoxon (Mann-Whitney)|||||||>0.05
71005328|NCT03676465|141518873|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|Wilcoxon (Mann-Whitney)|||||||>0.05
71005329|NCT03676465|141518874|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71005330|NCT03685643|141518881|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71005331|NCT03685643|141518882|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
71005332|NCT03685643|141518883|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
70925314|NCT03675282|141343777|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.3|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 1 (Baseline vs. 24 months)||||0.30
71005333|NCT02268942|141518900|OTHER|||||||0.0003|||||||Exact Binomial|||"Success at six months is estimated to be 86% compared to a performance goal of 77.5%. Using an exact binomial test, with a one-sided alpha of 0.05, and 80% Power, a sample size of 145 implanted subjects was planned.~Success will be met if the lower bound of the upper one-sided exact 95% confidence interval is greater than 77.5%."||||0.0003
71005334|NCT02268942|141518901|OTHER||||||<|0.0001|||||||t-test, 1 sided|||"The secondary endpoint is an improvement in the mean length of initial hospital stay (initial recovery and step down unit), which is calculated by considering the number of days in acute care (ICU/CCU) plus the number of days in intermediate/step-down care, comprising the total number of days post-implant to discharge.~This secondary endpoint will be calculated using an upper tail one-sided t-test at 0.05 level of significance compared to 26.1 days for median sternotomy patients."||||<0.0001
71005335|NCT00113555|141518916|SUPERIORITY||Mean Difference (Net)|-1.16|STANDARD_DEVIATION|1.05|<|0.001|TWO_SIDED|95.0|-1.325|-1.003|||Wilcoxon (Mann-Whitney)|||Wilcoxon's matched pairs signed ranks test was used to determine the significance of differences between scores at follow-up compared to pre-implant.||-1.003|-1.325|<0.001
71005336|NCT03398824|141518928|OTHER|Fanconi Anemia is a rare disease. Therefore, the primary end point of the study was to assess the proportion of subjects with a HR during 6 months of metformin treatment; sample size was calculated assuming that a HR rate \< 20% suggests preliminary efficacy of treatment that warranted additional investigation and, conversely, that the study should be deemed futile if the rate of HR was \<5%.|response rate|30.8|||||TWO_SIDED|90.0|11.3|57.3|||||||Fanconi Anemia is a rare disease. Therefore, the primary end point of the study was to assess the proportion of subjects with a HR during 6 months of metformin treatment; sample size was calculated assuming that a HR rate \>20% suggests preliminary efficacy of treatment that warranted additional investigation and, conversely, that the study should be deemed futile if the rate of HR was \<5%.|57.3|11.3|
71005337|NCT04337203|141518953|OTHER|Feasibility study and calculated confidence interval.||||||0.54|||||||Independent samples proportions test|||||||0.54
71101725|NCT04250207|141711178|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||<|0.0001|||||||Chi-square or Fisher exact|||Week 12||||< 0.0001
71005338|NCT04191096|141518979|OTHER||Hazard Ratio (HR)|1.2||||0.9467|TWO_SIDED|95.0|0.96|1.49||A one-sided p-value was calculated using the log-rank test stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No).|||1.49|0.96|0.9467
71005339|NCT04191096|141518980|OTHER||Hazard Ratio (HR)|1.16||||0.85122|TWO_SIDED|95.0|0.88|1.53||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||1.53|0.88|0.85122
71005340|NCT04191096|141518981|OTHER||Hazard Ratio (HR)|1.24||||0.97907|TWO_SIDED|95.0|1.01|1.54||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||1.54|1.01|0.97907
71005341|NCT04191096|141518982|OTHER||Hazard Ratio (HR)|0.89||||0.27202|TWO_SIDED|95.0|0.61|1.3||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||1.30|0.61|0.27202
71005342|NCT04191096|141518983|OTHER||Hazard Ratio (HR)|0.92||||0.2972|TWO_SIDED|95.0|0.69|1.23||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||1.23|0.69|0.2972
71101726|NCT04250207|141711178|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0028|||||||Chi-square or Fisher exact|||Week 12||||0.0028
70925315|NCT03675282|141343777|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.94|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 2 (Baseline vs. 24 months)||||0.94
70925316|NCT03675282|141343777|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.45|TWO_SIDED||||||paired t-test|||REM Sleep Behavior Disorder (Baseline vs. 24 months)||||0.45
70925317|NCT03675282|141343777|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.8|TWO_SIDED||||||paired t-test|||Healthy Controls (Baseline vs. 24 months)||||0.80
70925318|NCT03056040|141343786|NON_INFERIORITY|A difference in percent change in LDH between the ravulizumab and eculizumab treatment groups at Day 183 along with a 2-sided 95% confidence interval (CI) was calculated. Noninferiority margin (NIM) was based on the upper bound of the 95% CI. NIM was 15%.|Treatment Difference|-9.21|||||TWO_SIDED|95.0|-18.84|0.42|||||Treatment difference was estimated for ravulizumab - eculizumab.|Adjusting for a possible 10% dropout rate, a minimum of 192 participants were estimated to provide 90% power to demonstrate noninferiority of ravulizumab to eculizumab.||0.42|-18.84|
70925319|NCT03056040|141343787|NON_INFERIORITY|NIM was based on the upper bound of the 95% CI. NIM was 20%.|Treatment Difference|-5.1|||||TWO_SIDED|95.0|-18.99|8.89|||||Treatment difference was estimated for ravulizumab - eculizumab.|A difference in the percentages of participants with BTH was calculated between the ravulizumab and eculizumab treatment groups, along with a 95% CI for the difference using the stratified Newcombe CI method. The stratification factor observed was transfusion history within 1 year prior to first dose of study drug.||8.89|-18.99|
70925320|NCT03056040|141343788|NON_INFERIORITY|NIM was based on the lower bound of the 95% CI. NIM margin was -3.|Treatment Difference|1.47|||||TWO_SIDED|95.0|-0.21|3.15|||||Treatment difference was estimated for ravulizumab - eculizumab.|||3.15|-0.21|
70925321|NCT03056040|141343789|NON_INFERIORITY|NIM was based on the lower bound of the 95% CI. NIM was -20%.|Treatment Difference|5.5|||||TWO_SIDED|95.0|-4.27|15.68|||||Treatment difference was estimated for ravulizumab - eculizumab.|A difference in the percentages of participants achieving transfusion avoidance was calculated between the ravulizumab and eculizumab treatment groups, along with a 95% CI for the difference using the stratified Newcombe CI method. The stratification factor observed was transfusion history within 1 year prior to first dose of study drug||15.68|-4.27|
70925322|NCT03056040|141343790|NON_INFERIORITY|NIM was based on the lower bound of the 95% CI. NIM was -20%.|Treatment Difference|1.4|||||TWO_SIDED|95.0|-10.41|13.31|||||Treatment difference was estimated for ravulizumab - eculizumab.|A difference in the percentages of participants with stabilized hemoglobin was calculated between the ravulizumab and eculizumab treatment groups, along with a 95% CI for the difference using the stratified Newcombe CI method. The stratification factor observed was transfusion history within 1 year prior to first dose of study drug.||13.31|-10.41|
70925323|NCT05875142|141343829|NON_INFERIORITY|test of non-inferiority is H0: control\>=treatment vs HA: control\<treatment||||||0.0008|||||||t-test, 1 sided|||T compared with TM||||0.0008
70925324|NCT05875142|141343829|NON_INFERIORITY|test of non-inferiority is H0: control\>=treatment vs HA: control\<treatment||||||5.03e-06|||||||t-test, 1 sided|||T compared with TMC.||||0.00000503
70925325|NCT05875142|141343830|NON_INFERIORITY|test of non-inferiority is H0: control\>=treatment vs HA: control\<treatment||||||0.0176|||||||t-test, 1 sided|||T compared with T||||0.0176
70925326|NCT05875142|141343830|NON_INFERIORITY|test of non-inferiority is H0: control\>=treatment vs HA: control\<treatment||||||0.0056|||||||t-test, 1 sided|||Comparing T with TMC.||||0.0056
70925327|NCT05875142|141343831|NON_INFERIORITY|test of non-inferiority is H0: control\<=treatment vs HA: control\>treatment||||||0.4066|||||||t-test, 1 sided|||T compared with TM||||0.4066
71044720|NCT02985879|141598557|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|25.44|=|0.829|TWO_SIDED|95.0|-55.66|44.63|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||44.63|-55.66|=0.829
70925328|NCT05875142|141343831|NON_INFERIORITY|test of non-inferiority is H0: control\<=treatment vs HA: control\>treatment||||||0.4045|||||||t-test, 1 sided|||T compared with TMC||||0.4045
70925329|NCT04274764|141343838|OTHER|||||||0.7399|||||||Chi-squared|||||||0.7399
70925330|NCT02677298|141343839|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70925331|NCT02677298|141343840|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary Outcome Measure shows a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||||||<0.001
71101727|NCT04250207|141711178|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||<|0.0001|||||||Chi-square or Fisher exact|||Week 16||||< 0.0001
71101728|NCT04250207|141711178|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0011|||||||Chi-square or Fisher exact|||Week 16||||0.0011
70925332|NCT02677298|141343841|SUPERIORITY|||||||0.003||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||||||0.003
71101729|NCT04250207|141711178|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0094|||||||Chi-square or Fisher exact|||Week 20||||0.0094
70925333|NCT02677298|141343842|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||Test performed for Investigator's In-clinic Assessment||||<0.001
70925334|NCT02677298|141343842|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||Test performed for Subject's In-clinic Assessment||||<0.001
70925335|NCT02677298|141343843|SUPERIORITY|||||||0.084||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||Test performed for responders rates at week 20||||0.084
71005343|NCT04191096|141518984|OTHER||Hazard Ratio (HR)|1.07||||0.6863|TWO_SIDED|95.0|0.81|1.41||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||1.41|0.81|0.6863
71005344|NCT04191096|141518985|OTHER||Hazard Ratio (HR)|1.15||||0.9235|TWO_SIDED|95.0|0.95|1.39||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||1.39|0.95|0.9235
71044721|NCT02985879|141598557|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-32.9|STANDARD_ERROR_OF_MEAN|25.92|=|0.206|TWO_SIDED|95.0|-83.94|18.23|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||18.23|-83.94|=0.206
71044722|NCT02985879|141598558|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|3.88|=|0.304|TWO_SIDED|95.0|-3.65|11.65|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||11.65|-3.65|=0.304
71044723|NCT02985879|141598558|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|4.5|STANDARD_ERROR_OF_MEAN|3.88|=|0.243|TWO_SIDED|95.0|-3.11|12.19|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||12.19|-3.11|=0.243
71044724|NCT02985879|141598559|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-26.4|STANDARD_ERROR_OF_MEAN|53.86||0.625|TWO_SIDED|95.0|-132.76|79.94|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||79.94|-132.76|0.625
71044725|NCT02985879|141598559|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|33.2|STANDARD_ERROR_OF_MEAN|55.47|=|0.55|TWO_SIDED|95.0|-76.34|142.71|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||142.71|-76.34|=0.550
71044726|NCT02985879|141598560|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|1739.1|STANDARD_ERROR_OF_MEAN|2502.95|=|0.488|TWO_SIDED|95.0|-3201.75|6680.02|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||6680.02|-3201.75|=0.488
71101730|NCT04250207|141711178|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.1281|||||||Chi-square or Fisher exact|||Week 20||||0.1281
70925336|NCT02677298|141343844|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for the Modified Skindex-16 (GL-QoL) Emotional domain change from baseline at week 4||||<0.001
71005345|NCT04191096|141518986|OTHER||Hazard Ratio (HR)|1.16||||0.8801|TWO_SIDED|95.0|0.9|1.5||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No).|||1.50|0.90|0.8801
71005346|NCT04191096|141518987|OTHER||Percent Difference|-2.7||||0.9576|TWO_SIDED|95.0|-5.8|0.4||One-sided p-value based on Miettinen \& Nurminen method stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No) with small strata.|Miettinen & Nurminen method||Percent difference and associated 95% CI were calculated using Miettinen \& Nurminen method stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No).|||0.4|-5.8|0.9576
71005347|NCT04191096|141518988|OTHER||Percent difference|-0.8||||0.6053|TWO_SIDED|95.0|-6.3|4.8||One-sided p-value based on Miettinen \& Nurminen method stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No) with small strata.|Miettinen & Nurminen||Percent difference and associated 95% CI were calculated using Miettinen \& Nurminen method stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||4.8|-6.3|0.6053
71005348|NCT04191096|141518989|OTHER||Percent difference|-5.6||||0.9105|TWO_SIDED|95.0|-13.7|2.6||One-sided p-value based on Miettinen \& Nurminen method stratified prior docataxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No) with small strata.|Miettinen & Nurminen||Percent difference and associated 95% CI were calculated using Miettinen \& Nurminen method stratified by prior docataxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||2.6|-13.7|0.9105
71005349|NCT01654224|141519032|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.005||||||A/California/07/2009(H1N1)|t-test, 2 sided|||||||.005
71005350|NCT01654224|141519032|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.001||||||A/Victoria/210/2009(H3N2)|t-test, 2 sided|||||||.001
71005351|NCT01654224|141519032|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.004||||||B/Brisbane/60/2008|t-test, 2 sided|||||||.004
71005352|NCT01654224|141519032|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.672||||||A/California/07/2009(H1N1)|t-test, 2 sided|||||||.672
71005353|NCT01654224|141519032|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.011||||||A/Victoria/361/2011(H3N2)|t-test, 2 sided|||||||.011
71005354|NCT01654224|141519032|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.01||||||B/Texas/6/2011|t-test, 2 sided|||||||.010
71005355|NCT01654224|141519033|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.074||||||A/California/07/2009(H1N1)|t-test, 2 sided|||||||.074
71005356|NCT01654224|141519033|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.006||||||A/Victoria/210/2009(H3N2)|t-test, 2 sided|||||||.006
71005357|NCT01654224|141519033|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.069||||||B/Brisbane/60/2008|t-test, 2 sided|||||||.069
71005358|NCT01654224|141519033|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.663||||||A/California/07/2009(H3N2)|t-test, 2 sided|||||||.663
71005359|NCT01654224|141519033|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.003||||||A/Victoria/361/2011(H3N2)|t-test, 2 sided|||||||.003
71005360|NCT01654224|141519033|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.063||||||B/Texas/6/2011|t-test, 2 sided|||||||.063
71005361|NCT01654224|141519034|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.917||||||A/California/07/2009(H1N1)|t-test, 2 sided|||||||.917
71005362|NCT01654224|141519034|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.36||||||A/Victoria/210/2009(H3N2)|t-test, 2 sided|||||||.360
71005363|NCT01654224|141519034|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.248||||||B/Brisbane/60/2008|t-test, 2 sided|||||||.248
71005364|NCT01654224|141519034|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.178||||||A/California/07/2009(H1N1)|t-test, 2 sided|||||||.178
71005365|NCT01654224|141519034|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.152||||||A/Victoria/361/2011(H1N2)|t-test, 2 sided|||||||.152
71005366|NCT01654224|141519034|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.285||||||B/Texas/6/2011|t-test, 2 sided|||||||.285
71005367|NCT03345849|141519035|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and European Union/European Medicines Agency regulatory purposes.|Adjusted Response Rate Difference|20.8|||<|0.0001|TWO_SIDED|95.0|12.7|28.8|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|Comparison of the upadacitinib group and placebo group was performed using the Cochran Mantel-Haenszel (CMH) test adjusting for stratification factors (baseline steroid use \[Yes, No\], endoscopic disease severity \[SES-CD \< 15, ≥ 15\] and number of prior biologics with prior inadequate response or intolerance \[0, 1, \> 1\]).||28.8|12.7|<0.0001
71005368|NCT03345849|141519036|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Adjusted Response Rate Difference|28.7|||<|0.0001|TWO_SIDED|95.0|20.9|36.4|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||36.4|20.9|<0.0001
71005369|NCT03345849|141519037|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Adjusted Response Rate Difference|33.0|||<|0.0001|TWO_SIDED|95.0|26.2|39.9|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||39.9|26.2|<0.0001
71005370|NCT03345849|141519038|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Adjusted Response Rate Difference|21.8|||<|0.0001|TWO_SIDED|95.0|15.8|27.8|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||27.8|15.8|<0.0001
71005371|NCT03345849|141519039|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints. This endpoint was a ranked key secondary endpoint for US/FDA regulatory purposes.|Adjusted Response Rate Difference|27.7|||<|0.0001|TWO_SIDED|95.0|15.7|39.8|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors endoscopic disease severity and number of prior failed biologic therapies.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors endoscopic disease severity and number of prior biologic failed.|||39.8|15.7|<0.0001
71005372|NCT03345849|141519040|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Least Squares (LS) Mean Difference|6.3|STANDARD_ERROR_OF_MEAN|1.05|<|0.0001|TWO_SIDED|95.0|4.2|8.3|||Mixed-effect Model Repeated Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, stratification factors, and Baseline value as covariate.||||8.3|4.2|<0.0001
71005373|NCT03345849|141519041|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|LS Mean Difference|21.842|STANDARD_ERROR_OF_MEAN|3.1933|<|0.0001|TWO_SIDED|95.0|15.566|28.118|||Mixed-effect Model Repeated Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, stratification factors, and Baseline value as covariate.||||28.118|15.566|<0.0001
71005374|NCT03345849|141519042|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Adjusted Response Rate Difference|11.7||||0.0022|TWO_SIDED|95.0|4.2|19.2|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||19.2|4.2|0.0022
71005375|NCT03345849|141519043|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Adjusted Response Rate Difference|19.8|||<|0.0001|TWO_SIDED|95.0|11.3|28.4|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||28.4|11.3|<0.0001
71005376|NCT03345849|141519044|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints. This endpoint was a ranked key secondary endpoint for US/FDA regulatory purposes.|Adjusted Response Rate Difference|10.8||||0.0071|TWO_SIDED|95.0|2.9|18.6|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||18.6|2.9|0.0071
71005377|NCT03345849|141519045|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Response Rate Difference|-1.4||||0.4494|TWO_SIDED|95.0|-5.2|2.4|||Chi-squared||Response rate difference = Upadacitinib - Placebo|||2.4|-5.2|0.4494
71005378|NCT03345849|141519046|OTHER|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Adjusted Response Rate Difference|9.0||||0.1044|TWO_SIDED|95.0|-1.9|19.9|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||19.9|-1.9|0.1044
71044727|NCT02985879|141598560|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|3684.9|STANDARD_ERROR_OF_MEAN|2487.32|=|0.14|TWO_SIDED|95.0|-1225.46|8595.29|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||8595.29|-1225.46|=0.140
71044728|NCT02985879|141598561|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|207.9|STANDARD_ERROR_OF_MEAN|592.68|=|0.726|TWO_SIDED|95.0|-962.98|1378.88|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||1378.88|-962.98|=0.726
71044729|NCT02985879|141598561|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|133.6|STANDARD_ERROR_OF_MEAN|611.91|=|0.828|TWO_SIDED|95.0|-1075.26|1342.4|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||1342.40|-1075.26|=0.828
71044730|NCT00595335|141598563|SUPERIORITY_OR_OTHER|||||||0.73|||||||t-test, 2 sided|||Comparison of the change between the two groups' CAS score at 6 months.||||0.73
71044731|NCT00595335|141598564|SUPERIORITY_OR_OTHER|||||||0.75|||||||Fisher Exact|||Comparison of the change between the two groups' failure rate at 6 months.||||0.75
71044732|NCT00595335|141598564|SUPERIORITY_OR_OTHER|||||||0.85|||||||Fisher Exact|||Comparison of the change between the two groups' failure rate at 12 months.||||0.85
71044733|NCT00595335|141598566|SUPERIORITY_OR_OTHER|||||||0.97|||||||t-test, 2 sided|||Comparison of the change between the two groups in proptosis in the right eye at 12 months.||||0.97
71044734|NCT00595335|141598566|SUPERIORITY_OR_OTHER|||||||0.86|||||||t-test, 2 sided|||Comparison of the change between the two groups in change in proptosis in left eye at 12 months.||||0.86
71044735|NCT00595335|141598567|SUPERIORITY_OR_OTHER|||||||0.98|||||||t-test, 2 sided|||Comparison of the change in lid fissure in the right eye between the two groups.||||0.98
71044736|NCT00595335|141598567|SUPERIORITY_OR_OTHER|||||||0.49|||||||t-test, 2 sided|||Comparison of the change in lid fissure in the left eye between the two groups.||||0.49
71044737|NCT00595335|141598568|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||Comparison of change between groups in extraocular motility at 6 months.||||0.21
71044738|NCT00595335|141598568|SUPERIORITY_OR_OTHER|||||||0.64|||||||t-test, 2 sided|||Comparison of change between groups in extraocular motility at 12 months.||||0.64
71044739|NCT00595335|141598569|SUPERIORITY_OR_OTHER|||||||0.36|||||||t-test, 2 sided|||Comparison of the arms for QoL SF-12 physical score at 6 months.||||0.36
71044740|NCT00595335|141598569|SUPERIORITY_OR_OTHER|||||||0.91|||||||t-test, 2 sided|||Comparison of the arms for QoL SF-12 mental score at 6 months.||||0.91
71044741|NCT00595335|141598569|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||Comparison of the arms for QoL SF-12 physical score at 12 months.||||0.29
71044742|NCT00595335|141598569|SUPERIORITY_OR_OTHER|||||||0.18|||||||t-test, 2 sided|||Comparison of the arms for QoL SF-12 mental score at 12 months.||||0.18
71005379|NCT03345849|141519047|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Adjusted Response Rate Difference|21.2|||<|0.0001|TWO_SIDED|95.0|14.3|28.2|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||28.2|14.3|<0.0001
71005380|NCT03345849|141519048|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Adjusted Response Rate Difference|32.6|||<|0.0001|TWO_SIDED|95.0|21.5|43.7|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||43.7|21.5|<0.0001
71005381|NCT02943577|141519071|SUPERIORITY||Least Squares Mean Difference|-1.0||||0.2398|TWO_SIDED|95.0|-2.7|0.68|||Mixed Model Repeated Measures (MMRM)|||||0.68|-2.70|0.2398
71005382|NCT02943577|141519072|SUPERIORITY||Least Squares Mean Difference|0.4||||0.5522|TWO_SIDED|95.0|-0.95|1.77|||Mixed Model Repeated Measures (MMRM)|||||1.77|-0.95|0.5522
71005383|NCT02943577|141519073|SUPERIORITY||Least Squares Mean Difference|0.0||||0.9901|TWO_SIDED|95.0|-2.01|1.99|||Mixed Model Repeated Measures (MMRM)|||||1.99|-2.01|0.9901
71005384|NCT02943577|141519074|SUPERIORITY||Least Squares Mean Difference|0.5||||0.5563|TWO_SIDED|95.0|-1.17|2.17|||Mixed Model Repeated Measures (MMRM)|||||2.17|-1.17|0.5563
71005385|NCT01355224|141519075|SUPERIORITY_OR_OTHER|||||||0.015|||||||Regression, Linear|Adjusted for age, gender, BMI, baseline intention.||||||.0150
71044743|NCT00595335|141598570|SUPERIORITY_OR_OTHER|||||||0.85|||||||Fisher Exact|||Comparison of the change between the two groups' failure rate at 12 months.||||0.85
71044744|NCT01131299|141598600|SUPERIORITY_OR_OTHER|||||||0.82|||||||t-test, 2 sided|||The minimum sample size to detect an 8 mg/dl change in total plasma cholesterol between the placebo and alpha cyclodextrin periods is 62 subjects. The power is 80% by using the normal approximation to a one-sample (paired) two-tail t-test at an alpha of 0.05.||||0.82
71044745|NCT01131299|141598601|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
71005386|NCT01355224|141519076|SUPERIORITY_OR_OTHER|||||||0.0365|||||||Regression, Linear|Adjusted for age, gender, BMI, and baseline intent.||||||0.0365
71044746|NCT01131299|141598602|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.05
71005387|NCT01355224|141519077|SUPERIORITY_OR_OTHER|||||||0.0622|||||||Regression, Linear|Adjusted for age, gender, BMI, and baseline intent.||||||0.0622
71005388|NCT04437511|141519083|SUPERIORITY||LS Mean change difference (Final Values)|2.92|STANDARD_ERROR_OF_MEAN|0.72|<|0.001|TWO_SIDED|95.0|1.508|4.331|||Mixed Models Analysis|||||4.331|1.508|<0.001
71005389|NCT04437511|141519084|SUPERIORITY||LS Mean change difference (Final Values)|3.25|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|1.883|4.618|||Mixed Models Analysis|||||4.618|1.883|<0.001
71044747|NCT01131299|141598603|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
71005390|NCT04437511|141519085|SUPERIORITY||LS Mean change difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.19||0.012|TWO_SIDED|95.0|0.104|0.841|||Mixed Models Analysis|||||0.841|0.104|0.012
71005391|NCT04437511|141519086|SUPERIORITY||LS Mean change difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.2||0.016|TWO_SIDED|95.0|0.089|0.868|||Mixed Models Analysis|||||0.868|0.089|0.016
71005392|NCT04437511|141519087|SUPERIORITY||LS Mean change difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.39||0.0006|TWO_SIDED|95.0|-2.086|-0.565|||Mixed Models Analysis|||||-0.565|-2.086|0.0006
71005393|NCT04437511|141519088|SUPERIORITY||LS Mean change difference (Final Values)|-1.52|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.25|-0.794|||Mixed Models Analysis|||||-0.794|-2.250|<0.001
71005394|NCT04437511|141519089|SUPERIORITY||LS Mean change difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.127|<|0.001|TWO_SIDED|95.0|-0.95|-0.45|||Mixed Models Analysis|||||-0.45|-0.95|<0.001
71005395|NCT04437511|141519090|SUPERIORITY||LS Mean change difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.141|<|0.001|TWO_SIDED|95.0|-0.95|-0.4|||Mixed Models Analysis|||||-0.40|-0.95|<0.001
71005396|NCT04437511|141519091|SUPERIORITY||LS Mean change difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|0.44||0.0001|TWO_SIDED|95.0|0.84|2.566|||Mixed Models Analysis|||||2.566|0.840|0.0001
71005397|NCT04437511|141519092|SUPERIORITY||LS Mean change difference (Final Values)|1.83|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|0.913|2.748|||Mixed Models Analysis|||||2.748|0.913|<0.001
71005398|NCT04437511|141519093|SUPERIORITY||LS Mean change difference (Final Values)|-86.37|STANDARD_ERROR_OF_MEAN|1.275|<|0.0001|TWO_SIDED|95.0|-88.87|-83.87|||Mixed Models Analysis|||||-83.87|-88.87|<0.0001
71005399|NCT04437511|141519094|SUPERIORITY||LS Mean change difference (Final Values)|-0.0041||||0.4522|TWO_SIDED|95.0|-0.0148|0.0066|||ANCOVA|||||0.0066|-0.0148|0.4522
71005400|NCT04437511|141519095|SUPERIORITY||LS Mean change difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.007||0.002|TWO_SIDED|95.0|0.01|0.04|||Mixed Models Analysis|||Bilateral Hippocampus||0.04|0.01|0.002
71005401|NCT04437511|141519095|SUPERIORITY||LS Mean change difference (Final Values)|-6.66|STANDARD_ERROR_OF_MEAN|0.561|<|0.001|TWO_SIDED|95.0|-7.76|-5.56|||Mixed Models Analysis|||Bilateral Whole Brain||-5.56|-7.76|<0.001
71101731|NCT04250207|141711178|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0051|||||||Chi-square or Fisher exact|||Week 24||||0.0051
71101732|NCT04250207|141711178|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.1313|||||||Chi-square or Fisher exact|||Week 24||||0.1313
71044748|NCT03686150|141598618|OTHER|This was a population PK analysis of 25(OH)D after oral administration of Vitamin D.||||||||||||||||Part 1 of this study was to perform a population PK analysis of 25(OH)D after oral administration of Vitamin D in children who are overweight or obese and have asthma. Based on the interim analysis of the VDORA study, the PK of 25(OH)D after Vitamin D supplementation in children was well characterized by a 2-compartment population PK model with linear absorption and elimination kinetics. A loading dose of 50,000 IU followed by a daily dose of 8,000 IU was recommended.|Based on the interim analysis of the VDORA study, the PK of 25(OH)D after Vitamin D supplementation in children was well characterized by a 2-compartment population PK model with linear absorption and elimination kinetics. A loading dose of 50,000 IU followed by a daily dose of 8,000 IU was recommended.|||
71044749|NCT03686150|141598619|OTHER|This is one-sample test of proportion testing the null hypothesis that the proportion of participants with 25(OH)D level \>= 40 ng/mL is 50%.||||||0.0001|||||||z-test|||This is a one-sample test of proportion.||||0.0001
71044750|NCT01252719|141598637|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority hypothesis test was a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two-sided 95% CI for the difference in response rates in the mITT population was greater than -10%, the NI of oritavancin to vancomycin was concluded.|Difference in Proportions|-0.4|||||TWO_SIDED|95.0|-5.5|4.7||||||||4.7|-5.5|
71005402|NCT04437511|141519095|SUPERIORITY||LS Mean change difference (Final Values)|3.02|STANDARD_ERROR_OF_MEAN|0.256|<|0.001|TWO_SIDED|95.0|2.52|3.52|||Mixed Models Analysis|||Bilateral Ventricles||3.52|2.52|<0.001
71005403|NCT04654468|141519103|SUPERIORITY||||||<|0.0001|||||||Paired McNemar|||Percentage of participants who achieved TA from baseline through Week 25 were compared with the percentage of participants who reported TA within 24 weeks prior to screening.||||<.0001
71005404|NCT05306964|141519152|OTHER|||||||0.5|||||||GLMM|||||||0.5
71005405|NCT05306964|141519153|OTHER|||||||0.4|||||||GLMM|||||||0.4
71005406|NCT05306964|141519154|OTHER|||||||0.5|||||||GLMM|||||||0.5
71005407|NCT05306964|141519155|OTHER|||||||0.3|||||||GLMM|||||||0.3
71005408|NCT05306964|141519156|OTHER|||||||0.4|||||||GLMM|||||||0.4
71005409|NCT05306964|141519157|OTHER|||||||0.5|||||||GLMM|||||||0.5
71005410|NCT05306964|141519158|OTHER|||||||0.3|||||||GLMM|||||||0.3
71005411|NCT05306964|141519159|OTHER|||||||0.3|||||||GLMM|||||||0.3
71005412|NCT05306964|141519160|OTHER|||||||0.7|||||||GLMM|||||||0.7
71044751|NCT01252719|141598638|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority hypothesis test was a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two-sided 95% confidence interval (CI) for the difference in response rates in the mITT population was greater than -10% the non-inferiority (NI) of oritavancin to vancomycin was concluded.|Difference in Proportions|3.4|||||TWO_SIDED|95.0|-1.6|8.4||||||||8.4|-1.6|
71005413|NCT05306964|141519161|OTHER|||||||0.2|||||||GLMM|||||||0.2
71005414|NCT05306964|141519162|OTHER|||||||0.02|||||||GLMM|||||||0.02
71005415|NCT05306964|141519163|OTHER|||||||0.2|||||||GLMM|||||||0.2
71005416|NCT05306964|141519164|OTHER|||||||0.7|||||||GLMM|||||||0.7
71005417|NCT05306964|141519165|OTHER|||||||0.1|||||||GLMM|||||||0.1
71005418|NCT05306964|141519166|OTHER|||||||0.2|||||||GLMM|||||||0.2
71101733|NCT04250207|141711178|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0268|||||||Chi-square or Fisher exact|||Week 38||||0.0268
71101734|NCT04250207|141711178|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.3652|||||||Chi-square or Fisher exact|||Week 38||||0.3652
71005419|NCT05306964|141519167|OTHER||||||<|0.001|||||||GLMM|||||||<0.001
71005420|NCT05306964|141519168|OTHER|||||||0|||||||GLMM|||||||0
71005421|NCT05306964|141519169|OTHER|||||||0.5|||||||GLMM|||||||0.5
71005422|NCT05306964|141519170|OTHER|||||||0.9|||||||GLMM|||||||0.9
71005423|NCT05306964|141519171|OTHER|||||||0.8|||||||GLMM|||||||0.8
71005424|NCT05306964|141519172|OTHER|||||||0|||||||GLMM|||||||0
71005425|NCT05306964|141519173|OTHER|||||||0|||||||GLMM|||||||0
71005426|NCT05306964|141519174|OTHER|||||||0.2|||||||GLMM|||||||0.2
71005427|NCT05306964|141519175|OTHER|||||||0|||||||GLMM|||||||0
71005428|NCT05306964|141519176|OTHER|||||||0.9|||||||GLMM|||||||0.9
71005429|NCT05306964|141519177|OTHER|||||||0|||||||GLMM|||||||0
71005430|NCT05306964|141519178|OTHER|||||||0.9|||||||GLMM|||||||0.9
71005431|NCT05306964|141519179|OTHER|||||||0|||||||GLMM|||||||0
71005432|NCT05306964|141519180|OTHER|||||||0|||||||GLMM|||||||0
71005433|NCT05306964|141519181|OTHER|||||||0|||||||GLMM|||||||0
71005434|NCT05306964|141519182|OTHER|||||||0.5|||||||GLMM|||||||0.5
71005435|NCT05306964|141519183|OTHER|||||||0.2|||||||GLMM|||||||0.2
71005436|NCT05306964|141519184|OTHER|||||||0.3|||||||GLMM|||||||0.3
71005437|NCT03811535|141519234|NON_INFERIORITY|The pre-specified non-inferiority margin was -1.8 cm/year.|Treatment difference|-0.5|||||TWO_SIDED|95.0|-1.1|0.2|||ANCOVA|||Height velocity at week 52 was analyzed using an analysis of covariance model with treatment, gender, age group, region, growth hormone (GH) peak group and gender by age group by region interaction term as factors, and baseline height as covariate.||0.2|-1.1|
71005438|NCT03811535|141519235|NON_INFERIORITY|The pre-specified non-inferiority margin was -1.8 cm/year.|Treatment difference|-0.5|||||TWO_SIDED|95.0|-1.1|0.2|||Mixed Models Analysis|||Height velocity at 52 weeks was analyzed using a mixed model for repeated measurements, with treatment, gender, age group, region, GH peak group and gender by age group by region interaction terms as factors and baseline height as a covariate, all nested within week as a factor.||0.2|-1.1|
71005439|NCT05564039|141519263|SUPERIORITY||LS Mean difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.69|||Mixed Models Analysis|||||-0.69|-1.10|<0.0001
71005440|NCT05564039|141519264|SUPERIORITY||LS Mean difference (Final Values)|-7.4|||<|0.0001|TWO_SIDED|95.0|-8.7|-6.0|||Mixed Models Analysis|||||-6.0|-8.7|<.0001
71005441|NCT05564039|141519265|SUPERIORITY||Odds Ratio (OR)|7.13|||<|0.0001|TWO_SIDED|95.0|3.82|13.32|||Regression, Logistic|||||13.32|3.82|<0.0001
71005442|NCT05564039|141519266|SUPERIORITY||Odds Ratio (OR)|12.24|||<|0.0001|TWO_SIDED|95.0|6.51|23.02|||Regression, Logistic|||||23.02|6.51|<0.0001
71005443|NCT05564039|141519267|SUPERIORITY||Odds Ratio (OR)|15.34|||<|0.0001|TWO_SIDED|95.0|4.58|51.36|||Regression, Logistic|||||51.36|4.58|<0.0001
71005444|NCT05564039|141519268|SUPERIORITY||Odds Ratio (OR)|9.31|||<|0.0001|TWO_SIDED|95.0|5.11|16.98|||Regression, Logistic|||||16.98|5.11|<0.0001
71005445|NCT05564039|141519269|SUPERIORITY||Odds Ratio (OR)|19.35|||<|0.0001|TWO_SIDED|95.0|9.07|41.3|||Regression, Logistic|||||41.30|9.07|<0.0001
71005446|NCT05564039|141519270|SUPERIORITY||Odds Ratio (OR)|35.83|||<|0.0001|TWO_SIDED|95.0|7.18|178.89|||Regression, Logistic|||||178.89|7.18|<0.0001
71005447|NCT05564039|141519271|SUPERIORITY||Odds Ratio (OR)|20.44|||<|0.0001|TWO_SIDED|95.0|8.4|49.77|||Regression, Logistic|||||49.77|8.40|<0.0001
71005448|NCT05564039|141519272|SUPERIORITY||LS Mean difference (Final Values)|-0.9|||<|0.001|TWO_SIDED|95.0|-1.32|-0.49|||ANCOVA|||||-0.49|-1.32|<0.001
71005449|NCT05564039|141519273|SUPERIORITY||LS Mean difference (Final Values)|-5.1||||0.0002|TWO_SIDED|95.0|-7.8|-2.5|||Mixed Models Analysis|||||-2.5|-7.8|0.0002
71005450|NCT05564039|141519274|SUPERIORITY||LS Mean difference (Final Values)|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.1|-2.1|||Mixed Models Analysis|||||-2.1|-3.1|<0.0001
71005451|NCT05564039|141519275|SUPERIORITY||LS Mean difference (Final Values)|4.1||||0.1181|TWO_SIDED|95.0|-1.0|9.2|||ANCOVA|||||9.2|-1.0|0.1181
71005452|NCT04566445|141519286|SUPERIORITY||LS Mean Difference|0.062|STANDARD_ERROR_OF_MEAN|0.0901|||TWO_SIDED|90.0|-0.087|0.211|||mixed model repeated measures|||Week 12||0.211|-0.087|
71005453|NCT04566445|141519286|SUPERIORITY||LS Mean Difference|0.084|STANDARD_ERROR_OF_MEAN|0.091|||TWO_SIDED|90.0|-0.066|0.234|||mixed model repeated measures|||Week 12||0.234|-0.066|
71005454|NCT04566445|141519286|SUPERIORITY||LS Mean Difference|0.096|STANDARD_ERROR_OF_MEAN|0.1198|||TWO_SIDED|90.0|-0.102|0.294|||mixed model repeated measures|||Week 24||0.294|-0.102|
71005455|NCT04566445|141519286|SUPERIORITY||LS Mean Difference|0.205|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|90.0|0.007|0.404|||mixed model repeated measures|||Week 24||0.404|0.007|
71005456|NCT04566445|141519286|SUPERIORITY||LS Mean Difference|0.197|STANDARD_ERROR_OF_MEAN|0.2135|||TWO_SIDED|90.0|-0.155|0.55|||mixed model repeated measures|||Week 36||0.550|-0.155|
71005457|NCT04566445|141519286|SUPERIORITY||LS Mean Difference|0.423|STANDARD_ERROR_OF_MEAN|0.2152|||TWO_SIDED|90.0|0.068|0.779|||mixed model repeated measures|||Week 36||0.779|0.068|
71005458|NCT04566445|141519286|SUPERIORITY||LS Mean Difference|0.052|STANDARD_ERROR_OF_MEAN|0.2644|||TWO_SIDED|90.0|-0.385|0.489|||mixed model repeated measures|||Week 48||0.489|-0.385|
71005459|NCT04566445|141519286|SUPERIORITY||LS Mean Difference|0.488|STANDARD_ERROR_OF_MEAN|0.2662|||TWO_SIDED|90.0|0.049|0.928|||mixed model repeated measures|||Week 48||0.928|0.049|
71005460|NCT04566445|141519286|SUPERIORITY||LS Mean Difference|0.307|STANDARD_ERROR_OF_MEAN|0.3361|||TWO_SIDED|90.0|-0.248|0.862|||mixed model repeated measures|||Week 72||0.862|-0.248|
71005461|NCT04566445|141519286|SUPERIORITY||LS Mean Difference|0.503|STANDARD_ERROR_OF_MEAN|0.3392|||TWO_SIDED|90.0|-0.058|1.063|||mixed model repeated measures|||Week 72||1.063|-0.058|
71005462|NCT04566445|141519287|SUPERIORITY||LS Mean Difference|0.645|STANDARD_ERROR_OF_MEAN|0.4527|||TWO_SIDED|90.0|-0.103|1.393|||mixed model repeated measures|||Week 96||1.393|-0.103|
71005463|NCT04566445|141519287|SUPERIORITY||LS Mean Difference|0.838|STANDARD_ERROR_OF_MEAN|0.4577|||TWO_SIDED|90.0|0.081|1.594|||mixed model repeated measures|||Week 96||1.594|0.081|
71005464|NCT04566445|141519292|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.33|||TWO_SIDED|90.0|-2.6|1.7|||mixed model repeated measures|||Week 12||1.7|-2.6|
71005465|NCT04566445|141519292|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|-4.0|0.4|||mixed model repeated measures|||Week 12||0.4|-4.0|
71005466|NCT04566445|141519292|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-4.1|0.8|||mixed model repeated measures|||Week 24||0.8|-4.1|
71005467|NCT04566445|141519292|SUPERIORITY||LS Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|1.49|||TWO_SIDED|90.0|-7.7|-2.8|||mixed model repeated measures|||Week 24||-2.8|-7.7|
71005468|NCT04566445|141519292|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.81|||TWO_SIDED|90.0|-2.5|3.5|||mixed model repeated measures|||Week 36||3.5|-2.5|
71005469|NCT04566445|141519292|SUPERIORITY||LS Mean Difference|-4.7|STANDARD_ERROR_OF_MEAN|1.8|||TWO_SIDED|90.0|-7.7|-1.7|||mixed model repeated measures|||Week 36||-1.7|-7.7|
71005470|NCT04566445|141519292|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|2.14|||TWO_SIDED|90.0|-0.9|6.1|||mixed model repeated measures|||Week 48||6.1|-0.9|
71005471|NCT04566445|141519292|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|90.0|-5.6|1.4|||mixed model repeated measures|||Week 48||1.4|-5.6|
71005472|NCT04566445|141519292|SUPERIORITY||LS Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|2.24|||TWO_SIDED|90.0|1.0|8.4|||mixed model repeated measures|||Week 72||8.4|1.0|
71005473|NCT04566445|141519292|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|2.2|||TWO_SIDED|90.0|-2.8|4.5|||mixed model repeated measures|||Week 72||4.5|-2.8|
71005474|NCT04566445|141519292|SUPERIORITY||LS Mean Difference|7.1|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|90.0|2.7|11.6|||mixed model repeated measures|||Week 96||11.6|2.7|
71005475|NCT04566445|141519292|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|2.68|||TWO_SIDED|90.0|-1.8|7.1|||mixed model repeated measures|||Week 96||7.1|-1.8|
71005476|NCT02421939|141519297|OTHER||Hazard Ratio (HR)|0.637||||0.0004|TWO_SIDED|95.0|0.49|0.83||1-sided P-value|Log Rank||Based on Cox proportional hazards model. Assuming proportional hazards, an HR of \< 1 indicates a reduction in the hazard rate in favor of the gilteritinib arm|Stratified analysis where tratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.||0.830|0.490|0.0004
71005477|NCT02421939|141519299|OTHER||Hazard Ratio (HR)|0.793||||0.0415|TWO_SIDED|95.0|0.577|1.089||1-sided P-value|Log Rank||Based on the Cox proportional hazards model. Assuming proportional hazards, an HR of \< 1 indicates a reduction in the hazard rate in favor of the gilteritinib arm.|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT||1.089|0.577|0.0415
71005478|NCT02421939|141519300|OTHER||Adjusted Treatment Difference|10.6||||0.0106|TWO_SIDED|95.0|2.8|18.4||Stratified P-value|Cochran-Mantel-Haenszel|||Based on stratified Cochran-Mantel-Haenszel test. Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT. Treatment difference = gilteritinib -chemotherapy.||18.4|2.8|0.0106
71005479|NCT02421939|141519301|OTHER||Hazard Ratio (HR)|0.889||||0.6654|TWO_SIDED|95.0|0.506|1.563||Unstratified p-value|Log Rank||Based on the Cox proportional hazards model. Assuming proportional hazards, an HR of \< 1 indicates a reduction in the hazard rate in favor of the gilteritinib arm.|The LFS was analyzed for participants who achieved remission using the stratified log-rank test with strata to control for response to first-line AML therapy and preselected salvage chemotherapy. Duration of LFS was based on Kaplan-Meier estimates.||1.563|0.506|0.6654
71005480|NCT02421939|141519302|OTHER||Hazard Ratio (HR)|0.206||||0.1189|TWO_SIDED|95.0|0.022|1.886||Unstratified|Log Rank||Based on Cox proportional hazards model. Assuming proportional hazards, a hazard ratio \< 1 indicates a reduction in hazard rate in favor of gilteritinib arm.|||1.886|0.022|0.1189
71005481|NCT02421939|141519303|OTHER||Treatment difference|32.5|||<|0.0001|TWO_SIDED|95.0|22.3|42.6||Unstratified 2-sided P-value|2-sided Fisher's exact test|||Treatment difference = gilteritinib - chemotherapy. The 95% CIs were asymptotic confidence limits using the normal approximation to the binomial distribution.||42.6|22.3|<0.0001
71005482|NCT02421939|141519304|OTHER||Treatment Difference|10.2||||0.0333|TWO_SIDED|95.0|1.2|19.1||Unstratified 2-sided P-value.|2-sided Fisher's exact test|Treatment difference = gilteritinib - chemotherapy.||||19.1|1.2|0.0333
71005483|NCT02421939|141519305|OTHER||Least Squares Mean Difference|-1.2567||||0|||||||ANCOVA|||C1D8: Using analysis of covariance (ANCOVA) including treatment as a fixed factor, baseline score, response to first-line AML therapy and preselected salvage chemotherapy per IRT as covariates. Least Square (LS) Mean difference was estimated using chemotherapy as control.||||0.0000
71005484|NCT02421939|141519305|OTHER||Least Squares Mean Difference|0.1574||||0.8037|||||||ANCOVA|||C2D1: Using analysis of covariance (ANCOVA) including treatment as a fixed factor, baseline score, response to first-line AML therapy and preselected salvage chemotherapy per IRT as covariates. Least Square (LS) Mean difference was estimated using chemotherapy as control.||||0.8037
71005485|NCT02421939|141519306|OTHER||Adjusted Treatment Difference,|18.6|||<|0.0171|TWO_SIDED|95.0|9.8|27.4||Stratified 1-sided P-value.|Cochran-Mantel-Haenszel|||Based on a stratified Cochran-Mantel-Haenszel test. Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT. Pooled strata were used as shown in Table 12.3.3.2. Treatment differences were adjusted based on pooled strata. Treatment difference = gilteritinib 120 mg - chemotherapy.||27.4|9.8|<0.0171
71005486|NCT00557362|141519385|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.098||||0.29|TWO_SIDED|95.0|-0.28|0.083|||Regression, Linear|Multiple linear regression model adjusted for enrollment BSCVA and corneal de-epithelialization||||0.083|-0.28|0.29
71005487|NCT00557362|141519386|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.4|TWO_SIDED|95.0|0.76|2.02|||Regression, Cox|||||2.02|0.76|0.40
71005488|NCT00557362|141519387|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.37|TWO_SIDED|95.0|-0.2|0.53|||Regression, Linear|||||0.53|-0.20|0.37
71005489|NCT00557362|141519388|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.62|TWO_SIDED|95.0|-0.25|0.41|||Regression, Linear|||Best spectacle-corrected visual acuity (BSCVA) was examined in a linear regression model with enrollment BSCVA and treatment arm as covariates among a subgroup of ulcers caused by Fusarium spp.||0.41|-0.25|0.62
71005490|NCT00557362|141519388|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.26|TWO_SIDED|95.0|-0.57|0.17|||Regression, Linear|||Best spectacle-corrected visual acuity (BSCVA) was evaluated in a linear regression model with enrollment BSCVA and treatment arm as covariates in a subgroup of ulcers caused by Aspergillus spp.||0.17|-0.57|0.26
71005491|NCT00557362|141519389|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.53|TWO_SIDED|95.0|-0.26|0.14|||Regression, Linear|||||0.14|-0.26|0.53
71005492|NCT06408818|141519414|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.06||0.69|TWO_SIDED||||||Regression, Linear|||||||0.69
71005493|NCT06408818|141519415|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.33|TWO_SIDED||||||Regression, Linear|||||||0.33
71005494|NCT06408818|141519416|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.46|TWO_SIDED||||||Regression, Linear|||||||0.46
71005495|NCT06408818|141519417|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.06||0.46|TWO_SIDED||||||Regression, Linear|||||||0.46
71005496|NCT06408818|141519418|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.17||0.2|TWO_SIDED||||||Regression, Linear|||||||0.20
71005497|NCT06408818|141519419|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.11||0.22|TWO_SIDED||||||Regression, Linear|||||||0.22
71044752|NCT01252719|141598639|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority hypothesis test was a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two-sided 95% CI for the difference in response rates in the mITT population was greater than -10% the NI of oritavancin to vancomycin was concluded.|Difference in Proportions|4.1|||||TWO_SIDED|95.0|-0.5|8.6||||||||8.6|-0.5|
71005498|NCT06408818|141519420|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.19||0.48|TWO_SIDED||||||Regression, Linear|||||||0.48
71005499|NCT06408818|141519421|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.69|TWO_SIDED||||||Regression, Linear|||||||0.69
71005500|NCT06408818|141519422|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used logistic regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.63||0.22|TWO_SIDED||||||Regression, Logistic|||||||0.22
71005501|NCT06408818|141519423|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used logistic regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|-0.45|STANDARD_ERROR_OF_MEAN|0.79||0.57|TWO_SIDED||||||Regression, Logistic|||||||0.57
71005502|NCT06408818|141519424|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.1||0.42|TWO_SIDED||||||Regression, Linear|||||||0.42
71005503|NCT06408818|141519425|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.45|TWO_SIDED||||||Regression, Linear|||||||0.45
71005504|NCT06408818|141519426|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.39|TWO_SIDED||||||Regression, Linear|||||||0.39
71005505|NCT02723019|141519463|SUPERIORITY|||||||0.01|||||||Regression, Logistic|||Analyzed using logistic regression analysis||||0.01
71005506|NCT02723019|141519464|SUPERIORITY|||||||0.19|||||||Regression, Logistic|||||||0.19
71005507|NCT02723019|141519465|SUPERIORITY|||||||0.73||||||P-value is for the time by group interaction effect, testing the difference in rate of change between the Intervention and Control groups from baseline to 6 months post baseline|multilevel model analysis, random interc|||multilevel model analysis, random intercepts and slopes, appropriate link function for outcome, full maximum likelihood estimation||||0.73
71005508|NCT02723019|141519466|SUPERIORITY|||||||0.28||||||P-value is for the time by group interaction effect, testing the difference in rate of change between the Intervention and Control groups from baseline to 6 months post baseline|multilevel model analysis, random interc|||multilevel model analysis, random intercepts and slopes, appropriate link function for outcome, full maximum likelihood estimation||||0.28
71005509|NCT02723019|141519467|SUPERIORITY|||||||0.71||||||P-value is for the time by group interaction effect, testing the difference in rate of change between the Intervention and Control groups from baseline to 6 months post baseline|multilevel model analysis, random interc|||multilevel model analysis, random intercepts and slopes, appropriate link function for outcome, full maximum likelihood estimation||||0.71
71005510|NCT02723019|141519468|SUPERIORITY|||||||0.42|||||||negative binomial regression model analy|||negative binomial regression model analysis||||0.42
71005511|NCT00515099|141519485|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline ln(AUC+1) as a covariate and change in ln(AUC+1) from baseline as the outcome variable.|ANCOVA|||Primary imputation method used for missing Month 12 AUC. Measuring range for C-peptide is 0.05-30 ng/mL||||0.60
71005512|NCT00515099|141519486|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome variable|ANCOVA|||Missing Month 12 AUC values were not imputed. Measuring range for C-peptide is 0.05-30 ng/mL||||0.40
71005513|NCT00515099|141519487|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in insulin use from baseline as the outcome variable|ANCOVA|||Comparison of groups for change from baseline (pre-treatment initiation) to Month 12||||0.59
71005514|NCT00515099|141519487|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in insulin use from baseline as the outcome variable|ANCOVA|||Comparison of groups for change from baseline (pre-treatment initiation) to Month 24||||0.14
71005515|NCT00515099|141519489|SUPERIORITY_OR_OTHER||||||>|0.099|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in insulin use from baseline as the outcome variable|Fisher Exact|||Comparison of groups up to Month 12||||>0.099
71005516|NCT00515099|141519489|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in insulin use from baseline as the outcome variable|Fisher Exact|||Comparison of groups up to Month 24||||0.75
71005517|NCT00515099|141519490|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome variable|ANCOVA|||2-Hour AUC change from baseline (pre-initiation treatment) to Month 24. Primary imputation method used for missing Month 24 AUC. Measuring range for C-peptide is 0.05-30 ng/mL.||||0.38
71005518|NCT00515099|141519490|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome variable|ANCOVA|||4-Hour AUC change from baseline (pre-initiation treatment) to Month 24. Missing Month 24 AUC values were not imputed. Measuring range for C-peptide is 0.05-30 ng/mL.||||0.33
71005519|NCT00515099|141519491|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in HbA1c from baseline as the outcome variable|ANCOVA|||Comparison of groups for change from Baseline to Month 12||||0.07
71005520|NCT00515099|141519491|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in HbA1c from baseline as the outcome variable|ANCOVA|||Comparison of groups for change from Baseline to Month 24||||0.16
71005521|NCT02237898|141519547|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
71005522|NCT01708915|141519554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.362|STANDARD_ERROR_OF_MEAN|0.171|<|0.0001|TWO_SIDED|95.0|-1.699|-1.025||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.||||-1.025|-1.699|<0.0001
71005523|NCT01708915|141519554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.983|STANDARD_ERROR_OF_MEAN|0.173|<|0.0001|TWO_SIDED|95.0|-1.324|-0.642||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.||||-0.642|-1.324|<0.0001
71005524|NCT01708915|141519554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.158|STANDARD_ERROR_OF_MEAN|0.195||0.4171||95.0|-0.541|0.225||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.||||0.225|-0.541|0.4171
71005525|NCT01708915|141519555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.049|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001||95.0|-1.305|-0.793||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.||||-0.793|-1.305|<0.0001
71005526|NCT01708915|141519555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.731|STANDARD_ERROR_OF_MEAN|0.138|<|0.0001||95.0|-1.003|-0.459||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.||||-0.459|-1.003|<0.0001
71005527|NCT01708915|141519555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.058|STANDARD_ERROR_OF_MEAN|0.152||0.7037||95.0|-0.356|0.241||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.||||0.241|-0.356|0.7037
71005528|NCT01708915|141519556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.655|STANDARD_ERROR_OF_MEAN|0.208|<|0.0001||95.0|-2.064|-1.247|||ANCOVA|The statistical model included baseline PI, centre, and treatment.||||-1.247|-2.064|<0.0001
71005529|NCT01708915|141519556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.169|STANDARD_ERROR_OF_MEAN|0.209|<|0.0001||95.0|-1.578|-0.759|||ANCOVA|The statistical model included baseline PI, centre, and treatment.||||-0.759|-1.578|<0.0001
71005530|NCT01708915|141519556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.466|STANDARD_ERROR_OF_MEAN|0.209||0.0259||95.0|-0.875|-0.056|||ANCOVA|The statistical model included baseline PI, centre, and treatment.||||-0.056|-0.875|0.0259
71005531|NCT01708915|141519557|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.385|||<|0.0001||95.0|4.943|11.032|||Regression, Logistic|The logistic regression model included baseline PI, centre, and treatment.|Odds Ratio was calculated by Nicoboxil/Nonivamide : Placebo. Odds ratios \> 1 favour Nicoboxil/Nonivamide.|||11.032|4.943|<0.0001
71005532|NCT01708915|141519557|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.62|||<|0.0001||95.0|2.469|5.308|||Regression, Logistic|The logistic regression model included baseline PI, centre, and treatment.|Odds Ratio was calculated by Nicoboxil/Nonivamide : Nicoboxil. Odds ratios \> 1 favour Nicoboxil/Nonivamide.|||5.308|2.469|<0.0001
71005533|NCT01708915|141519557|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.594||||0.0129||95.0|1.104|2.303|||Regression, Logistic|The logistic regression model included baseline PI, centre, and treatment.|Odds Ratio was calculated by Nicoboxil/Nonivamide : Nonivamide. Odds ratios \> 1 favour Nicoboxil/Nonivamide.|||2.303|1.104|0.0129
71101735|NCT04250207|141711178|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.1854|||||||Chi-square or Fisher exact|||Week 52||||0.1854
71005534|NCT00908895|141519573|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|70.0|STANDARD_DEVIATION|25.0|<|0.05||95.0|||||Chi-squared|||We assess that 15% is a significative strength difference. According to a 80% study power, a SD at 25% and a 20% lost to follow-up, we found 118 patients for the all study.||||<0.05
71005535|NCT00908895|141519574|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|90.0|STANDARD_DEVIATION|10.0|<|0.05||95.0|80.0|100.0|||Chi-squared|||||100|80|<0.05
71005536|NCT00416572|141519576|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Regression, Linear|||Comparison between education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||> 0.05
71005537|NCT00416572|141519576|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||>0.05
71005538|NCT00416572|141519576|SUPERIORITY_OR_OTHER||standardized beta|-0.12|||=|0.08|TWO_SIDED||||||Regression, Linear|||Comparison between education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||=0.08
71005539|NCT00416572|141519576|SUPERIORITY_OR_OTHER||standardized beta|-0.23|||<|0.001|TWO_SIDED||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||<0.001
71005540|NCT00416572|141519577|SUPERIORITY_OR_OTHER||||||>|0.5|||||||Regression, Linear|||Comparison between education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||>0.50
71005541|NCT00416572|141519577|SUPERIORITY_OR_OTHER||Standardized beta|0.14|||=|0.04|TWO_SIDED||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||=0.04
71005542|NCT00416572|141519577|SUPERIORITY_OR_OTHER||Standardized beta|0.25|||<|0.001|TWO_SIDED||||||Regression, Linear|||Comparison between the education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||<0.001
71005543|NCT00416572|141519577|SUPERIORITY_OR_OTHER||Standardized beta|0.15|||=|0.02|TWO_SIDED||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||=0.02
71005544|NCT00416572|141519578|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Regression, Linear|||Comparison between education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome||||>.05
71005545|NCT00416572|141519578|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||>0.05
71005546|NCT00416572|141519578|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Regression, Linear|||Comparison between education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||>0.05
71005547|NCT00416572|141519578|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||>0.05
71005548|NCT00166504|141519579|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-10.0|STANDARD_DEVIATION|15.3|<|0.001||95.0|-14.3|-5.7|||ANOVA||Direction of the Comparison: Vytorin minus Atorvastatin.|||-5.7|-14.3|<0.001
71005549|NCT00723489|141519598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.86|TWO_SIDED|95.0|-0.3|0.2||P-value is not adjusted for multiple comparisons.|ANOVA||Mean (AD) - Mean (Non-AD)|||0.2|-0.3|0.86
71044753|NCT03135899|141598654|OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.064|||TWO_SIDED|90.0|-0.048|0.165|||Mixed Models Analysis||BI 443651 100 μg is compared to placebo.|The mixed effects model included 'treatment' and 'period' as fixed effects, 'patient' as a random effect, and 'period baseline' as well as 'patient baseline' as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.||0.165|-0.048|
71044754|NCT03135899|141598654|OTHER||Mean Difference (Final Values)|-0.037|STANDARD_ERROR_OF_MEAN|0.064|||TWO_SIDED|90.0|-0.144|0.07|||Mixed Models Analysis||BI 443651 400 μg is compared to placebo.|The mixed effects model included 'treatment' and 'period' as fixed effects, 'patient' as a random effect, and 'period baseline' as well as 'patient baseline' as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.||0.070|-0.144|
71044755|NCT03135899|141598654|OTHER||Mean Difference (Final Values)|-0.157|STANDARD_ERROR_OF_MEAN|0.066|||TWO_SIDED|90.0|-0.266|-0.047|||Mixed Models Analysis||BI 443651 1200 μg is compared to placebo.|The mixed effects model included 'treatment' and 'period' as fixed effects, 'patient' as a random effect, and 'period baseline' as well as 'patient baseline' as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.||-0.047|-0.266|
71005550|NCT00723489|141519599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.86|TWO_SIDED|95.0|-0.2|0.2||P-value is not adjusted for multiple comparisons.|ANOVA||Mean (AD) - Mean (Non-AD)|||0.2|-0.2|0.86
71005551|NCT00723489|141519600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.1|TWO_SIDED|95.0|-0.5|0.05||P-value is not adjusted for multiple comparisons.|ANOVA||Mean (AD) - Mean (Non-AD)|||0.05|-0.5|0.10
71005552|NCT00723489|141519601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.66|TWO_SIDED|95.0|-0.2|0.3||P-value is not adjusted for multiple comparisons.|ANOVA||Mean (AD) - Mean (Non-AD)|||0.3|-0.2|0.66
71005553|NCT00723489|141519602|SUPERIORITY_OR_OTHER|||||||0.24||||||P-value is not adjusted for multiple comparisons.|Fisher Exact|||||||0.24
71005554|NCT00723489|141519603|SUPERIORITY_OR_OTHER|||||||0.43||||||P-value is not adjusted for multiple comparisons.|Fisher Exact|||||||0.43
71005555|NCT00723489|141519604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values) Day 30|0.1||||0.48|TWO_SIDED|95.0|-0.1|0.3||P-value is not adjusted for multiple comparisons.|Mixed Models Analysis||Mean (AD) - Mean (Non-AD)|This analysis excludes 1 SC-(AD) participant who did not seroconvert. Only participants who had peripheral blood T-cell samples collected from Day 0 to Day 30 as specified in the Outcome Measure Time Frame were included in analysis (1 SC -(Non-AD) participant was excluded). T-cell data from 3 SC-(Non-AD) and 1 SC-(AD) participant was excluded due to problems with sample processing||0.3|-0.1|0.48
71005556|NCT00723489|141519605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values) Day 30|-0.3||||0.036|TWO_SIDED|95.0|-0.5|-0.02||P-value is not adjusted for multiple comparisons.|Mixed Models Analysis||Mean (AD) - Mean (Non-AD)|Participants who did not seroconvert were excluded from this analysis (2 TC-(AD) and 5 TC-(Non-AD)). T-cell data from 4 TC-(AD) and 3 TC-(Non-AD) subjects was excluded due to problems with sample processing||-0.02|-0.5|0.036
71005557|NCT00723489|141519606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values) Day 30|0.04||||0.82|TWO_SIDED|95.0|-0.3|0.4||P-value is not adjusted for multiple comparisons.|Mixed Models Analysis||Mean (AD) - Mean (Non-AD)|This analysis excludes 1 SC-(AD) participant who did not seroconvert. Only participants who had peripheral blood T-cell samples collected from Day 0 to Day 30 as specified in the Outcome Measure Time Frame were included in analysis (1 SC -(Non-AD) participant was excluded). T-cell data from 3 SC-(Non-AD) and 1 SC-(AD) participant was excluded due to problems with sample processing||0.4|-0.3|0.82
71005558|NCT00723489|141519607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values) Day 30|-0.4||||0.045|TWO_SIDED|95.0|-0.7|-0.01||P-value is not adjusted for multiple comparisons.|Mixed Models Analysis||Mean (AD) - Mean (Non-AD)|Participants who did not seroconvert were excluded from this analysis (2 TC-(AD) and 5 TC-(Non-AD)). T-cell data from 4 TC-(AD) and 3 TC-(Non-AD) subjects was excluded due to problems with sample processing||-0.01|-0.7|0.045
71005559|NCT00958191|141519802|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in HHS from pre-op to 1 year||||<0.0001
71005560|NCT00958191|141519802|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in HHS from pre-op to 3 years||||<0.0001
71005561|NCT00958191|141519802|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change in HHS from pre-op to 5 years||||<0.0001
71005562|NCT00958191|141519803|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Harris Hip Pain Score from pre-op to 1 year||||<0.0001
71005563|NCT00958191|141519803|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Harris Hip Pain Score from pre-op to 3 years||||<0.0001
71005564|NCT00958191|141519803|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Harris Hip Pain Score from pre-op to 5 years||||<0.0001
71005565|NCT00958191|141519804|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Harris Hip ROM score from pre-op to 1 year||||<0.0001
71005566|NCT00958191|141519804|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Harris Hip ROM score from pre-op to 3 years||||<0.0001
71005567|NCT00958191|141519804|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Harris Hip ROM score from pre-op to 5 years||||<0.0001
71005568|NCT00958191|141519805|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in SF-12 Phyiscal Component Score from preop to 1 year||||<0.0001
71005569|NCT00958191|141519805|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change in SF-12 Phyiscal Component Score from preop to 3 year||||<0.0001
71005570|NCT00958191|141519805|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in SF-12 Phyiscal Component Score from preop to 5 year||||<0.0001
71005571|NCT00958191|141519805|SUPERIORITY_OR_OTHER|||||||0.0242|||||||Sign test|||Change in SF-12 Mental Component Score from preop to 1 year||||0.0242
71005572|NCT00958191|141519805|SUPERIORITY_OR_OTHER|||||||0.0247|||||||Sign test|||Change in SF-12 Mental Component Score from preop to 3 year||||0.0247
71044756|NCT03135899|141598656|OTHER||Geometric Mean Ratio|0.77|STANDARD_ERROR_OF_MEAN|1.168|||TWO_SIDED|90.0|0.595|0.977|||Mixed Models Analysis||BI 443651 100 μg is compared to placebo. Standard error of the mean is actually geometric standard error.|The mixed effects model included 'treatment' and 'period' as fixed effects, 'patient' as a random effect, and 'period baseline' as well as 'patient baseline' as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.||0.977|0.595|
71101736|NCT04250207|141711178|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||>|0.9999|||||||Chi-square or Fisher exact|||Week 52||||> 0.9999
71101737|NCT04250207|141711179|SUPERIORITY|||||||0.0259|||||||Wilcoxon Rank Sum Test|||||||0.0259
71005573|NCT00958191|141519805|SUPERIORITY_OR_OTHER|||||||0.1372|||||||Sign test|||Change in SF-12 Mental Component Score from preop to 5 year||||0.1372
71005574|NCT00958191|141519806|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in LEAS Score from preop to 1 year||||<0.0001
71005575|NCT00958191|141519806|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in LEAS Score from preop to 3 year||||<0.0001
71005576|NCT00958191|141519806|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change in LEAS Score from preop to 5 year||||<0.0001
71005577|NCT01930487|141519908|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.037|STANDARD_ERROR_OF_MEAN|0.011||0.0016|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0016
71005578|NCT01930487|141519909|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.025|STANDARD_ERROR_OF_MEAN|0.011||0.0249|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0249
71005579|NCT01930487|141519910|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|1.3||0.9147|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.9147
71005580|NCT01930487|141519911|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.67|STANDARD_ERROR_OF_MEAN|0.59||0.007|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0070
71005581|NCT01930487|141519912|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.97|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED||||||paired t-test, 2-sidede||dietary supplement with antioxidants - placebo|||||<0.0001
71005582|NCT01930487|141519913|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|STANDARD_ERROR_OF_MEAN|0.23||0.0476|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0476
71005583|NCT01930487|141519914|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.45|STANDARD_ERROR_OF_MEAN|0.21||0.0352|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0352
71005584|NCT01930487|141519915|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.51|STANDARD_ERROR_OF_MEAN|0.21||0.0208|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0208
71005585|NCT01930487|141519916|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.38|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||<0.0001
71005586|NCT01930487|141519917|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.07||0.0024|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0024
71005587|NCT01930487|141519918|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.07||0.0081|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0081
71005588|NCT01930487|141519919|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.008||0.8191|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.8191
71005589|NCT01930487|141519920|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.018|STANDARD_ERROR_OF_MEAN|0.009||0.0482|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0482
71005590|NCT01930487|141519921|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.019|STANDARD_ERROR_OF_MEAN|0.023||0.023|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0230
71005591|NCT01930487|141519922|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.013|STANDARD_ERROR_OF_MEAN|0.008||0.1202|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.1202
71044757|NCT03135899|141598656|OTHER||Geometric Mean Ratio|0.926|STANDARD_ERROR_OF_MEAN|1.168|||TWO_SIDED|90.0|0.715|1.199|||Mixed Models Analysis||BI 443651 400 μg is compared to placebo. Standard error of the mean is actually geometric standard error.|The mixed effects model included 'treatment' and 'period' as fixed effects, 'patient' as a random effect, and 'period baseline' as well as 'patient baseline' as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.||1.199|0.715|
71044758|NCT03135899|141598656|OTHER||Geometric Mean Ratio|0.845|STANDARD_ERROR_OF_MEAN|1.169|||TWO_SIDED|90.0|0.651|1.095|||Mixed Models Analysis||BI 443651 1200 μg is compared to placebo. Standard error of the mean is actually geometric standard error.|The mixed effects model included 'treatment' and 'period' as fixed effects, 'patient' as a random effect, and 'period baseline' as well as 'patient baseline' as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.||1.095|0.651|
71044759|NCT03135899|141598658|OTHER||Hazard Ratio (HR)|2.27|||||TWO_SIDED|95.0|1.31|3.95|||Regression, Cox||BI 443651 100 μg is compared to placebo.|The cox proportional hazard model included treatment and period as fixed effect and patient baseline as covariate. No hypothesis was tested. The patient baseline was obtained by calculating the median of the period baselines for each patient. A hazard ratio greater than 1 gives that active treatment is not-inferior to placebo.||3.95|1.31|
71101738|NCT04250207|141711179|SUPERIORITY|||||||0.0068|||||||Wilcoxon Rank Sum Test|||||||0.0068
71005592|NCT01930487|141519923|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.55|STANDARD_ERROR_OF_MEAN|0.83||0.0063|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0063
71005593|NCT01930487|141519924|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|0.8||0.3347|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.3347
71005594|NCT01930487|141519925|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.02|STANDARD_ERROR_OF_MEAN|0.35||0.0094|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0094
71101739|NCT04250207|141711180|SUPERIORITY|||||||0.4435|||||||Wilcoxon Rank Sum Test|||Week 1||||0.4435
71101740|NCT04250207|141711180|SUPERIORITY|||||||0.3402|||||||Wilcoxon Rank Sum Test|||Week 1||||0.3402
71101741|NCT04250207|141711180|SUPERIORITY||||||>|0.9999|||||||Wilcoxon Rank Sum Test|||Week 2||||> 0.9999
71101742|NCT04250207|141711180|SUPERIORITY|||||||0.0655|||||||Wilcoxon Rank Sum Test|||Week 3||||0.0655
71101743|NCT04250207|141711180|SUPERIORITY|||||||0.0903|||||||Wilcoxon Rank Sum Test|||Week 3||||0.0903
71005595|NCT01930487|141519926|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.92|STANDARD_ERROR_OF_MEAN|0.24||0.0009|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0009
71005596|NCT01930487|141519927|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.02|STANDARD_ERROR_OF_MEAN|0.34||0.0067|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0067
71005597|NCT01930487|141519928|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.25||0.6938|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.6938
71005598|NCT01930487|141519929|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56|STANDARD_ERROR_OF_MEAN|0.3||0.0805|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0805
71005599|NCT01930487|141519930|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.29||0.2451|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.2451
71005600|NCT01930487|141519931|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.78|STANDARD_ERROR_OF_MEAN|0.34||0.0323|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0323
71005601|NCT01930487|141519932|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25|STANDARD_ERROR_OF_MEAN|0.26||0.344|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.3440
71005602|NCT01930487|141519933|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|0.13||0.0119|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0119
71005603|NCT01930487|141519934|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||<0.0001
71005604|NCT01930487|141519935|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.32|STANDARD_ERROR_OF_MEAN|0.12||0.0137|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0137
71005605|NCT01930487|141519936|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.09||0.0866|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0866
71005606|NCT01930487|141519937|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23|STANDARD_ERROR_OF_MEAN|0.12||0.0656|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0656
71005607|NCT01930487|141519938|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.19|STANDARD_ERROR_OF_MEAN|0.09||0.0626|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0626
71005608|NCT01930487|141519939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.003|STANDARD_ERROR_OF_MEAN|0.013||0.81|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.8100
71005609|NCT01930487|141519940|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.001|STANDARD_ERROR_OF_MEAN|0.01||0.9556|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.9556
71005610|NCT01930487|141519941|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.015|STANDARD_ERROR_OF_MEAN|0.015||0.3414|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.3414
71005611|NCT01930487|141519942|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.021|STANDARD_ERROR_OF_MEAN|0.009||0.033|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0330
71005612|NCT01930487|141519943|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.3326|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.3326
71005613|NCT01930487|141519944|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.027|STANDARD_ERROR_OF_MEAN|0.012||0.0348|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0348
71005614|NCT01930487|141519945|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.016|STANDARD_ERROR_OF_MEAN|0.012||0.2089|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.2089
71005615|NCT01930487|141519946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.012||0.3738|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.3738
71005616|NCT01930487|141519947|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|1.7||0.447|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.4470
71005617|NCT01930487|141519948|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|2.1||0.6382|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.6382
71044760|NCT03135899|141598658|OTHER||Hazard Ratio (HR)|2.08|||||TWO_SIDED|95.0|1.22|3.53|||Regression, Cox||BI 443651 400 μg is compared to placebo.|The cox proportional hazard model included treatment and period as fixed effect and patient baseline as covariate. No hypothesis was tested. The patient baseline was obtained by calculating the median of the period baselines for each patient. A hazard ratio greater than 1 gives that active treatment is not-inferior to placebo.||3.53|1.22|
71101744|NCT04250207|141711180|SUPERIORITY|||||||0.0216|||||||Wilcoxon Rank Sum Test|||Week 5||||0.0216
71101745|NCT04250207|141711180|SUPERIORITY|||||||0.002|||||||Wilcoxon Rank Sum Test|||Week 5||||0.0020
71005618|NCT01930487|141519949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.012||0.0026|TWO_SIDED||||||paird t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0026
71005619|NCT01930487|141519950|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.018||0.1045|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.1045
71005620|NCT01930487|141519951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.005|STANDARD_ERROR_OF_MEAN|0.013||0.6941|TWO_SIDED||||||paired t-test||dietary supplement with antioxidants - placebo|||||0.6941
71005621|NCT01930487|141519952|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.046|STANDARD_ERROR_OF_MEAN|0.017||0.0138|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0138
71005622|NCT01099761|141519992|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|TWO_SIDED||||||ANCOVA|||||||0.023
71005623|NCT01099761|141519992|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|TWO_SIDED||||||ANCOVA|||||||0.012
71005624|NCT01099761|141519992|SUPERIORITY_OR_OTHER_LEGACY|||||||0.435|TWO_SIDED||||||ANCOVA|||||||0.435
71005625|NCT01099761|141519993|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|TWO_SIDED||||||ANCOVA|||||||0.039
71005626|NCT01012037|141520037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.97|-0.52|||ANCOVA|||Linagliptin 2.5mg bid versus Placebo||-0.52|-0.97|<0.0001
71005627|NCT01012037|141520037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-1.02|-0.58|||ANCOVA|||Linagliptin 5mg qd versus Placebo||-0.58|-1.02|<0.0001
71005628|NCT01012037|141520037|NON_INFERIORITY_OR_EQUIVALENCE|The pre-defined non-inferiority margin was +0.35|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.07||||95.0|-0.07|0.19|||ANCOVA|||Linagliptin 2.5mg bid versus Linagliptin 5mg qd||0.19|-0.07|
71101746|NCT04250207|141711180|SUPERIORITY|||||||0.0676|||||||Wilcoxon Rank Sum Test|||Week 7||||0.0676
71101747|NCT04250207|141711180|SUPERIORITY|||||||0.0029|||||||Wilcoxon Rank Sum Test|||Week 7||||0.0029
71044761|NCT03135899|141598658|OTHER||Hazard Ratio (HR)|2.59|||||TWO_SIDED|95.0|1.5|4.47|||Regression, Cox||BI 443651 1200 μg is compared to placebo.|The cox proportional hazard model included treatment and period as fixed effect and patient baseline as covariate. No hypothesis was tested. The patient baseline was obtained by calculating the median of the period baselines for each patient. A hazard ratio greater than 1 gives that active treatment is not-inferior to placebo.||4.47|1.50|
71044762|NCT04146363|141598659|SUPERIORITY||Risk Difference (RD)|29.7|||<|1e-06|TWO_SIDED|95.0|21.6|37.8|||Cochran-Mantel-Haenszel|||||37.8|21.6|<0.000001
71005629|NCT01012037|141520038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.83|-0.48|||Mixed Models Analysis|||Linagliptin 2.5mg bid versus Placebo||-0.48|-0.83|<0.0001
71044763|NCT04146363|141598660|SUPERIORITY||Risk Difference (RD)|42.0|||<|1e-06|TWO_SIDED|95.0|33.3|50.6|||Cochran-Mantel-Haenszel|||||50.6|33.3|<0.000001
71044764|NCT04146363|141598661|SUPERIORITY||Risk Difference (RD)|1.7||||0.218644|TWO_SIDED|95.0|-0.6|4.0|||Cochran-Mantel-Haenszel|||||4.0|-0.6|0.218644
71044765|NCT04146363|141598662|SUPERIORITY||Risk Difference (RD)|9.6||||0.000498|TWO_SIDED|95.0|5.7|13.6|||Cochran-Mantel-Haenszel|||||13.6|5.7|0.000498
71044766|NCT04146363|141598663|SUPERIORITY||Risk Difference (RD)|30.8|||<|1e-06|TWO_SIDED|95.0|22.1|39.4|||Cochran-Mantel-Haenszel|||||39.4|22.1|<0.000001
71044767|NCT04146363|141598664|SUPERIORITY||Risk Difference (RD)|28.8|||<|1e-06|TWO_SIDED|95.0|21.3|36.3|||Cochran-Mantel-Haenszel|||||36.3|21.3|<0.000001
71044768|NCT04146363|141598665|SUPERIORITY||LS Mean Difference (Final Values)|-30.42|STANDARD_ERROR_OF_MEAN|3.915|<|1e-06|TWO_SIDED|95.0|-38.1|-22.7|||ANCOVA|||||-22.7|-38.1|<0.000001
71044769|NCT04146363|141598666|SUPERIORITY||Risk Difference (RD)|32.9|||<|1e-06|TWO_SIDED|95.0|24.6|41.3|||Cochran-Mantel-Haenszel|||||41.3|24.6|<0.000001
71044770|NCT04146363|141598667|SUPERIORITY||Risk Difference (RD)|35.1|||<|1e-06|TWO_SIDED|95.0|26.3|43.9|||Cochran-Mantel-Haenszel|||||43.9|26.3|<0.000001
71044771|NCT04146363|141598668|SUPERIORITY||LS Mean Difference (Final Values)|-38.31|STANDARD_ERROR_OF_MEAN|4.151|<|1e-06|TWO_SIDED|95.0|-46.4|-30.2|||ANCOVA|||||-30.2|-46.4|<0.000001
71044772|NCT04146363|141598669|SUPERIORITY||LS Mean Difference (Final Values)|-18.5|STANDARD_ERROR_OF_MEAN|2.0|<|1e-06|TWO_SIDED|95.0|-22.4|-14.5|||Mixed Models Analysis|||||-14.5|-22.4|<0.000001
71044773|NCT04146363|141598670|SUPERIORITY||Risk Difference (RD)|10.7||||0.000412|TWO_SIDED|95.0|6.2|15.2|||Cochran-Mantel-Haenszel|||||15.2|6.2|0.000412
71044774|NCT04146363|141598671|SUPERIORITY||LS Mean Difference (Final Values)|-5.8|STANDARD_ERROR_OF_MEAN|0.68|<|1e-06|TWO_SIDED|95.0|-7.1|-4.5|||ANCOVA|||||-4.5|-7.1|<0.000001
71044775|NCT04146363|141598672|SUPERIORITY||Risk Difference (RD)|38.8|||<|1e-06|TWO_SIDED|95.0|28.3|49.3|||Cochran-Mantel-Haenszel|||||49.3|28.3|<0.000001
71044776|NCT04146363|141598673|SUPERIORITY||Risk Difference (RD)|41.8|||<|1e-06|TWO_SIDED|95.0|31.2|52.3|||Cochran-Mantel-Haenszel|||||52.3|31.2|<0.000001
71044777|NCT04146363|141598674|SUPERIORITY||LS Mean Difference (Final Values)|-32.35|STANDARD_ERROR_OF_MEAN|5.23|<|1e-06|TWO_SIDED|95.0|-42.6|-22.1|||ANCOVA|||||-22.1|-42.6|<0.000001
71044778|NCT04146363|141598675|SUPERIORITY||LS Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.098|<|1e-06|TWO_SIDED|95.0|-0.9|-0.6|||ANCOVA|||||-0.6|-0.9|<0.000001
71044779|NCT04146363|141598676|SUPERIORITY||Risk Difference (RD)|34.6|||<|1e-06|TWO_SIDED|95.0|26.2|43.0|||Cochran-Mantel-Haenszel|||||43.0|26.2|<0.000001
71044780|NCT04146363|141598677|SUPERIORITY||Risk Difference (RD)|1.5||||0.275529|TWO_SIDED|95.0|-0.8|3.9|||Cochran-Mantel-Haenszel|||||3.9|-0.8|0.275529
71044781|NCT04146363|141598678|SUPERIORITY||Risk Difference (RD)|5.3||||0.016656|TWO_SIDED|95.0|1.9|8.6|||Cochran-Mantel-Haenszel|||||8.6|1.9|0.016656
71044782|NCT04146363|141598679|SUPERIORITY||Risk Difference (RD)|19.3||||3e-06|TWO_SIDED|95.0|13.7|25.0|||Cochran-Mantel-Haenszel|||||25.0|13.7|0.000003
71044783|NCT04146363|141598680|SUPERIORITY||Risk Difference (RD)|1.8||||0.244105|TWO_SIDED|95.0|-0.8|4.3|||Cochran-Mantel-Haenszel|||||4.3|-0.8|0.244105
71005630|NCT01012037|141520038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.84|-0.49|||Mixed Models Analysis|||Linagliptin 5mg qd versus Placebo||-0.49|-0.84|<0.0001
71005631|NCT01012037|141520038|NON_INFERIORITY_OR_EQUIVALENCE|The pre-defined non-inferiority margin was +0.35|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.05||||95.0|-0.1|0.1|||Mixed Models Analysis|||Linagliptin 2.5mg bid versus Linagliptin 5mg qd||0.10|-0.10|
71005632|NCT01012037|141520039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001||95.0|-1.0|-0.54|||Mixed Models Analysis|||Linagliptin 2.5mg bid versus Placebo||-0.54|-1.00|<0.0001
71005633|NCT01012037|141520039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001||95.0|-1.05|-0.59|||Mixed Models Analysis|||Linagliptin 5mg qd versus Placebo||-0.59|-1.05|<0.0001
71005634|NCT01012037|141520039|NON_INFERIORITY_OR_EQUIVALENCE|The pre-defined non-inferiority margin was +0.35|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.07||||95.0|-0.08|0.18|||Mixed Models Analysis|||Linagliptin 2.5mg bid versus Linagliptin 5mg qd||0.18|-0.08|
71005635|NCT01012037|141520040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|STANDARD_ERROR_OF_MEAN|4.6||0.0029||95.0|-22.7|-4.7|||ANCOVA|||Linagliptin 2.5mg bid versus Placebo||-4.7|-22.7|0.0029
71005636|NCT01012037|141520040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.8|STANDARD_ERROR_OF_MEAN|4.6||0.0001||95.0|-26.7|-8.8|||ANCOVA|||Linagliptin 5 mg qd versus Placebo||-8.8|-26.7|0.0001
71005637|NCT01012037|141520040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1|STANDARD_ERROR_OF_MEAN|2.6||||95.0|-1.0|9.2|||ANCOVA||No non-inferiority margin was pre-defined for FPG|Linagliptin 2.5mg bid versus Linagliptin 5mg qd||9.2|-1.0|
71005638|NCT01012037|141520041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.6|STANDARD_ERROR_OF_MEAN|4.4||0.0002||95.0|-25.3|-7.8|||Mixed Models Analysis|||Linagliptin 2.5mg bid versus Placebo||-7.8|-25.3|0.0002
71044784|NCT04146363|141598681|SUPERIORITY||Risk Difference (RD)|5.8||||0.01445|TWO_SIDED|95.0|2.2|9.4|||Cochran-Mantel-Haenszel|||||9.4|2.2|0.014450
71044785|NCT04146363|141598682|SUPERIORITY||Risk Difference (RD)|20.9||||2e-06|TWO_SIDED|95.0|14.9|26.9|||Cochran-Mantel-Haenszel|||||26.9|14.9|0.000002
71044786|NCT04146363|141598683|SUPERIORITY||LS Mean Difference (Final Values)|-30.29|STANDARD_ERROR_OF_MEAN|3.203|<|1e-06|TWO_SIDED|95.0|-36.59|-24.0|||ANCOVA|||||-24.00|-36.59|<0.000001
71101748|NCT04250207|141711180|SUPERIORITY|||||||0.0335|||||||Wilcoxon Rank Sum Test|||Week 9||||0.0335
71101749|NCT04250207|141711180|SUPERIORITY|||||||0.0053|||||||Wilcoxon Rank Sum Test|||Week 9||||0.0053
71101750|NCT04250207|141711180|SUPERIORITY|||||||0.0608|||||||Wilcoxon Rank Sum Test|||Week 12||||0.0608
71101751|NCT04250207|141711180|SUPERIORITY|||||||0.0071|||||||Wilcoxon Rank Sum Test|||Week 12||||0.0071
71101752|NCT04250207|141711180|SUPERIORITY|||||||0.4406|||||||Wilcoxon Rank Sum Test|||Week 16||||0.4406
71101753|NCT04250207|141711180|SUPERIORITY|||||||0.1716|||||||Wilcoxon Rank Sum Test|||Week 16||||0.1716
71101754|NCT04250207|141711180|SUPERIORITY|||||||0.9856|||||||Wilcoxon Rank Sum Test|||Week 20||||0.9856
71101755|NCT04250207|141711180|SUPERIORITY|||||||0.2229|||||||Wilcoxon Rank Sum Test|||Week 20||||0.2229
71101756|NCT04250207|141711180|SUPERIORITY|||||||0.8817|||||||Wilcoxon Rank Sum Test|||Week 24||||0.8817
71101757|NCT04250207|141711180|SUPERIORITY|||||||0.2081|||||||Wilcoxon Rank Sum Test|||||||0.2081
71044787|NCT04146363|141598685|SUPERIORITY||Risk Difference (RD)|17.9||||0.072375|TWO_SIDED|95.0|-2.3|38.1|||Cochran-Mantel-Haenszel|||||38.1|-2.3|0.072375
71044788|NCT04146363|141598685|SUPERIORITY||Risk Difference (RD)|17.5||||0.106653|TWO_SIDED|95.0|-4.5|39.5|||Cochran-Mantel-Haenszel|||||39.5|-4.5|0.106653
71044789|NCT04146363|141598686|SUPERIORITY||Risk Difference (RD)|28.0||||0.029857|TWO_SIDED|95.0|2.8|53.2|||Cochran-Mantel-Haenszel|||||53.2|2.8|0.029857
71044790|NCT04146363|141598686|SUPERIORITY||Risk Difference (RD)|29.0||||0.019744|TWO_SIDED|95.0|4.6|53.3|||Cochran-Mantel-Haenszel|||||53.3|4.6|0.019744
71044791|NCT04146363|141598687|SUPERIORITY||Risk Difference (RD)|15.8||||0.268265|TWO_SIDED|95.0|-12.2|43.8|||Cochran-Mantel-Haenszel|||||43.8|-12.2|0.268265
71044792|NCT04146363|141598687|SUPERIORITY||Risk Difference (RD)|16.6||||0.192776|TWO_SIDED|95.0|-9.4|42.7|||Cochran-Mantel-Haenszel|||||42.7|-9.4|0.192776
71101758|NCT04250207|141711180|SUPERIORITY|||||||0.7335|||||||Wilcoxon Rank Sum Test|||Week 38||||0.7335
71101759|NCT04250207|141711180|SUPERIORITY|||||||0.5367|||||||Wilcoxon Rank Sum Test|||Week 38||||0.5367
71101760|NCT04250207|141711180|SUPERIORITY|||||||0.555|||||||Wilcoxon Rank Sum Test|||Week 52||||0.5550
71101761|NCT04250207|141711180|SUPERIORITY|||||||0.8718|||||||Wilcoxon Rank Sum Test|||Week 52||||0.8718
71101762|NCT03654326|141711183|SUPERIORITY||Difference in Least Squares Mean|-0.5||||0.066|TWO_SIDED|95.0|-1.01|0.03||Based on the longitudinal analysis of covariance (ANCOVA) model including factors for average pelvic pain scores at baseline cycle, stratum, treatment, cycle, interaction of stratum-by-cycle, and the interaction of treatment-by-cycle as covariates|ANCOVA|||||0.03|-1.01|0.066
71101763|NCT03654326|141711184|OTHER|Difference in percentage of participants who experienced one or more adverse events|Difference in % vs Placebo|17.7|||||TWO_SIDED|95.0|3.4|31.3|||||Based on Miettinen \& Nurminen method|||31.3|3.4|
71101764|NCT03654326|141711185|OTHER|Difference in percentage of participants who discontinued study drug due to an adverse event|Difference in % vs Placebo|3.2|||||TWO_SIDED|95.0|-0.9|9.0|||||Based on Miettinen \& Nurminen method|||9.0|-0.9|
71101765|NCT03654326|141711186|OTHER|The difference in least squares mean was based on the longitudinal analysis of covariance (ANCOVA) model including factors for average pelvic pain scores at baseline cycle, stratum, treatment, cycle, interaction of stratum-by-cycle, and the interaction of treatment-by-cycle as covariates|Difference in Least Squares Mean|-0.6|||||TWO_SIDED|95.0|-1.18|-0.06||||||||-0.06|-1.18|
71101766|NCT03654326|141711187|OTHER|The difference in least squares mean was based on the longitudinal analysis of covariance (ANCOVA) model including factors for average pelvic pain scores at baseline cycle, stratum, treatment, cycle, interaction of stratum-by-cycle, and the interaction of treatment-by-cycle as covariates|Difference in Least Squares Mean|-0.5|||||TWO_SIDED|95.0|-1.04|0.03||||||||0.03|-1.04|
71101767|NCT00835549|141711207|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.6||||||90.0|94.8|102.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||102|94.8|
70925337|NCT02677298|141343844|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||This test was performed for the Modified Skindex-16 (GL-QoL) Functioning domain - Change from baseline at Week 4||||<0.001
71005639|NCT01012037|141520041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.9|STANDARD_ERROR_OF_MEAN|4.4|<|0.0001||95.0|-27.6|-10.2|||Mixed Models Analysis|||Linagliptin 5mg qd versus Placebo||-10.2|-27.6|<0.0001
71005640|NCT01012037|141520041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|2.5||||95.0|-2.6|7.3|||Mixed Models Analysis||No non-inferiority margin was pre-defined for FPG|Linagliptin 2.5mg bid versus Linagliptin 5mg qd||7.3|-2.6|
71005641|NCT01012037|141520042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.0|STANDARD_ERROR_OF_MEAN|5.4||0.0653||95.0|-20.6|0.6|||Mixed Models Analysis|||Linagliptin 2.5mg bid versus Placebo||0.6|-20.6|0.0653
71005642|NCT01012037|141520042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3|STANDARD_ERROR_OF_MEAN|5.4||0.0047||95.0|-25.8|-4.7|||Mixed Models Analysis|||Linagliptin 5mg qd versus Placebo||-4.7|-25.8|0.0047
71005643|NCT01012037|141520042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3|STANDARD_ERROR_OF_MEAN|3.0||||95.0|-0.7|11.3|||Mixed Models Analysis||No non-inferiority margin was pre-defined for FPG|Linagliptin 2.5mg bid versus Linagliptin 5mg qd||11.3|-0.7|
71005644|NCT00415623|141520056|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.7|||<|0.001||95.0|-9.0|-4.4|||ANCOVA|||The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). ANCOVA models with the trough SBP at baseline, body weight, and age as covariates, and the treatment group and study site as factors was used. The test was performed with a significance level of 0.05 (two-sided).||-4.4|-9.0|<0.001
71005645|NCT00415623|141520057|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|||<|0.001||95.0|-5.7|-2.5|||ANCOVA|||The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). ANCOVA models with the trough DBP at baseline, body weight, and age as covariates, and the treatment group and study site as factors was used. The test was performed with a significance level of 0.05 (two-sided).||-2.5|-5.7|<0.001
71005646|NCT00415623|141520058|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.1|||<|0.001||95.0|-9.1|-5.1|||ANCOVA|||The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). ANCOVA models with the trough SBP at baseline, body weight, and age as covariates, and the treatment group and study site as factors was used. The test was performed with a significance level of 0.05 (two-sided).||-5.1|-9.1|<0.001
71005647|NCT00415623|141520059|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.0|||<|0.001||95.0|-5.4|-2.6|||ANCOVA|||The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). ANCOVA models with the trough DBP at baseline, body weight, and age as covariates, and the treatment group and study site as factors was used. The test was performed with a significance level of 0.05 (two-sided).||-2.6|-5.4|<0.001
71005648|NCT00415623|141520060|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.33||||0.002||95.0|1.36|3.99|||Regression, Logistic|||Proportions of participants (responder rates) were used for the statistical analyses. The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). The test was conducted based on a logistic regression model with baseline SBP value and body weight as covariates, and treatment group and age (\<=64, \>=65) as a factor. The significance level was 0.05 (two-sided).||3.99|1.36|0.002
71044793|NCT04146363|141598688|SUPERIORITY||Risk Difference (RD)|18.6||||0.185361|TWO_SIDED|95.0|-9.3|46.6|||Cochran-Mantel-Haenszel|||||46.6|-9.3|0.185361
71044794|NCT04146363|141598688|SUPERIORITY||Risk Difference (RD)|16.6||||0.192776|TWO_SIDED|95.0|-9.4|42.7|||Cochran-Mantel-Haenszel|||||42.7|-9.4|0.192776
71044795|NCT04146363|141598689|SUPERIORITY||LS Mean Difference (Final Values)|-1.75|STANDARD_ERROR_OF_MEAN|4.756||0.714208|TWO_SIDED|95.0|-11.15|7.66|||ANCOVA|||||7.66|-11.15|0.714208
71044796|NCT04146363|141598689|SUPERIORITY||LS Mean Difference (Final Values)|-5.63|STANDARD_ERROR_OF_MEAN|4.4748||0.237855|TWO_SIDED|95.0|-15.01|3.76|||ANCOVA|||||3.76|-15.01|0.237855
71044797|NCT04146363|141598690|SUPERIORITY||LS Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.02|<|1e-06|TWO_SIDED|95.0|0.1|0.2|||ANCOVA|||UK||0.2|0.1|<0.000001
71044798|NCT04146363|141598690|SUPERIORITY||LS Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.01|<|1e-06|TWO_SIDED|95.0|0.1|0.1|||ANCOVA|||US||0.1|0.1|<0.000001
71044799|NCT04146363|141598691|SUPERIORITY||LS Mean Difference (Final Values)|8.3|STANDARD_ERROR_OF_MEAN|1.66|<|1e-06|TWO_SIDED|95.0|5.0|11.5|||ANCOVA|||||11.5|5.0|<0.000001
71044800|NCT04146363|141598692|SUPERIORITY||LS Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|0.8|<|1e-06|TWO_SIDED|95.0|-8.9|-5.7|||Mixed Models Analysis|||||-5.7|-8.9|<0.000001
71044801|NCT04146363|141598693|SUPERIORITY||LS Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|2.917||0.716224|TWO_SIDED|95.0|-6.93|4.8|||ANCOVA|||||4.80|-6.93|0.716224
71044802|NCT04146363|141598694|SUPERIORITY||LS Mean Difference (Final Values)|-4.51|STANDARD_ERROR_OF_MEAN|2.599||0.089275|TWO_SIDED|95.0|-9.73|0.72|||ANCOVA|||||0.72|-9.73|0.089275
71044803|NCT04146363|141598695|SUPERIORITY||LS Mean Difference (Final Values)|-3.31|STANDARD_ERROR_OF_MEAN|0.796||4e-05|TWO_SIDED|95.0|-4.88|-1.75|||ANCOVA|||||-1.75|-4.88|0.000040
71044804|NCT04146363|141598696|SUPERIORITY||LS Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.697||0.000127|TWO_SIDED|95.0|-4.07|-1.33|||ANCOVA|||||-1.33|-4.07|0.000127
71044805|NCT04146363|141598697|SUPERIORITY||LS Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.121||0.455291|TWO_SIDED|95.0|-0.33|0.15|||ANCOVA|||||0.15|-0.33|0.455291
71044806|NCT04146363|141598698|SUPERIORITY||LS Mean Difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|1.52||6.9e-05|TWO_SIDED|95.0|-10.1|-3.9|||Mixed Models Analysis|||||-3.9|-10.1|0.000069
71044807|NCT02914236|141598703|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Hypothesis was that the mean improvement in NOSE score exceeded 15 points||||||<0.0001
71044808|NCT02914236|141598704|SUPERIORITY||||||<|0.0001|||||||binomial test|Success threshold required at least 55% of subjects to be responders||||||<0.0001
71044809|NCT00441350|141598708|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71005649|NCT00415623|141520061|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.46|||<|0.001||95.0|2.28|8.74|||Regression, Logistic|||Proportions of participants (responder rates) were used for the statistical analyses. The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). The test was conducted based on a logistic regression model with baseline SBP value and body weight as covariates, and treatment group and age (\<=64, \>=65) as a factor. The significance level was 0.05 (two-sided).||8.74|2.28|<0.001
71044810|NCT00441350|141598709|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||< 0.0001
71005650|NCT00415623|141520062|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.55||||0.001||95.0|1.5|4.36|||Regression, Logistic|||Proportions of participants (responder rates) were used for the statistical analyses. The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). The test was conducted based on a logistic regression model with baseline SBP value and body weight as covariates, and treatment group and age (\<=64, \>=65) as a factor. The significance level was 0.05 (two-sided).||4.36|1.50|0.001
71005651|NCT00415623|141520063|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.16|||<|0.001||95.0|2.12|8.19|||Regression, Logistic|||Proportions of participants (responder rates) were used for the statistical analyses. The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). The test was conducted based on a logistic regression model with baseline SBP value and body weight as covariates, and treatment group and age (\<=64, \>=65) as a factor. The significance level was 0.05 (two-sided).||8.19|2.12|<0.001
71005652|NCT05307523|141520069|OTHER|Paired t-test for normally distributed data Wilcoxon Rank test for the not normally distributed data|||||<|0.05||||||Paired T-test for the normally distributed data and a Wilcoxon Rank test for the non-parametric data were used|Both Paired T-test and Wilcoxon Rank|The data included both normally and not normally distributed data for the baseline, mid-study, and final study assessment points.||||||<0.05
71005653|NCT01855867|141520079|SUPERIORITY|Statistical significance was determined at the alpha 0.05 level. The study regimen completion rates of participants in the current study taking a fixed dose once daily combination of elvitegravir/cobicistat/TDF/FTC were compared to historical controls who used PEP regimens consisting of TDF/FTC daily and raltegravir twice daily, or earlier regimens of twice daily zidovudine (AZT)/lamivudine (3TC) and a protease inhibitor, using chi-square tests for independence.|chi square||||<|0.05||||||Reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|Chi-squared|||using historical controls||||<0.05
71005654|NCT00678249|141520081|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71005655|NCT01045551|141520090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.98|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05.|t-test, 2 sided|||||||0.98
71005656|NCT01045551|141520091|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09|STANDARD_DEVIATION|0.9024|||TWO_SIDED|||||||||||||
71005657|NCT00542425|141520095|SUPERIORITY_OR_OTHER||||||<|0.001||0.0|||||ANOVA|||Study size provided 95 percent power to detect a difference in means of 114 (ng/mL) for PINP endpoint between BA058 (SD=147.5) and placebo (SD=34.5). Study size was based on Bauer 2006 data and utilized a 2-tailed 2-sample t-test with a significance level of alpha=0.01 with a Bonferonni adjustment for multiple testing. It included a 10 percent adjustment for within study dropouts over 6 months and a 15 percent adjustment to maintain adequate power for a per protocol analysis of key endpoints.||||<0.001
71044811|NCT00441350|141598710|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||< 0.0001
71044812|NCT00441350|141598711|SUPERIORITY|||||||0.0001|||||||ANCOVA|||||||0.0001
71101768|NCT00835549|141711208|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.0||||||90.0|98.5|105.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||105|98.5|
71005658|NCT00542425|141520095|SUPERIORITY_OR_OTHER||||||<|0.001||0.0|||||ANOVA|||Study size provided 95 percent power to detect a difference in means of 114 (ng/mL) for PINP endpoint between BA058 (SD=147.5) and placebo (SD=34.5). Study size was based on Bauer 2006 data and utilized a 2-tailed 2-sample t-test with a significance level of alpha=0.01 with a Bonferonni adjustment for multiple testing. It included a 10 percent adjustment for within study dropouts over 6 months and a 15 percent adjustment to maintain adequate power for a per protocol analysis of key endpoints.||||<0.001
71044813|NCT01332578|141598719|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-20.92||||0.0004|TWO_SIDED|95.0|-27.31|-15.81|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimate of median difference was determined.|Null hypothesis was no difference between test hot drink and standard paracetamol tablets.||-15.81|-27.31|0.0004
71044814|NCT02695719|141598755|SUPERIORITY||Median Values of CI|1.0||||0.007|TWO_SIDED|95.0|0.1|1.9||No adjustment was made as there was only one primary comparison.|Van Elteren Test|The Van Elteren test is a stratified version of the Wilcoxon-Mann-Whitney test which provides approximate sample size for the van Elteren analysis.|CI was estimated by inverting the hypothesis test.|Assuming equal allocation, a power of 90%, an alpha level of 0.05 for a 2-sided test, a placebo mean of 4 (standard deviation of 2.7), and a treatment mean of 5.9 (standard deviation of 4) for SBM frequency at Week 1 and using Wilcoxon-Mann-Whitney test, a total sample size of 146 is required. Analysis was conducted using van Elteren test.||1.9|0.1|0.007
71044815|NCT02129647|141598774|OTHER||||||||||||||||||10 tissue matched historical controls were analyzed. The Median (Full Range) of the histoscore was 122 (60 to 265)|||
71005659|NCT00542425|141520096|SUPERIORITY_OR_OTHER||||||<|0.001||0.0|||||ANOVA|||For the BMD endpoint, the planned study size has 80 percent power with alpha=0.02 to detect a difference in mean change from baseline of 3.0 (percent) in BMD for the BA058 group and the BA058 Placebo group using an assumed SD of 3.5-4.0. The estimates for SD are based upon results of lumbar spine BMD presented by Body 2002.||||<0.001
71044816|NCT02129647|141598775|OTHER||||||||||||||||||10 tissue matched historical controls were analyzed. The Median (Full Range) of the histoscore was 135 (100 to 240)|||
71044817|NCT02129647|141598776|OTHER||||||||||||||||||10 tissue matched historical controls were analyzed. The Median (Full Range) of the histoscore was 12 (0 to 100)|||
71005660|NCT00542425|141520096|SUPERIORITY_OR_OTHER||||||<|0.001||0.0|||||ANOVA|||For the BMD endpoint, the planned study size has 80 percent power with alpha=0.02 to detect a difference in mean change from baseline of 3.0 (percent) in BMD for the BA058 group and the BA058 Placebo group using an assumed SD of 3.5-4.0. The estimates for SD are based upon results of lumbar spine BMD presented by Body 2002.||||<0.001
71044818|NCT01715896|141598805|SUPERIORITY_OR_OTHER||Percent difference|-3.5||||0.666|TWO_SIDED|90.0|-16.8|9.8|||Logit response Model||P-value and 90% unconditional exact confidence interval (CI) was calculated using the model of logit (response) = strata + treatment.|||9.8|-16.8|0.666
71044819|NCT01715896|141598806|SUPERIORITY_OR_OTHER||Percent difference|-8.6||||0.293|TWO_SIDED|90.0|-22.0|4.8|||Logit response Model||P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.|||4.8|-22.0|0.293
71005661|NCT02096471|141520105|SUPERIORITY|Single group study. Change in Pain from Baseline amongst those with a tumor response|Mean Difference (Final Values)|1.38|STANDARD_ERROR_OF_MEAN|0.84||0.11|TWO_SIDED||||||t-test, 2 sided|Descriptive analysis only||Single group change from baseline||||0.11
71005662|NCT02096471|141520105|SUPERIORITY|Single Group Study. Change in Pain from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|0.8||0.01|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.01
71005663|NCT02096471|141520105|SUPERIORITY|Single Group Study. Change in Pain from Baseline amongst those with a Tumor Response|Mean Difference (Final Values)|0.89|STANDARD_ERROR_OF_MEAN|0.66||0.18|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.18
71005664|NCT02096471|141520105|SUPERIORITY|Single Group Study. Change in Quality of Life (QOL) from Baseline amongst those with a Tumor Response|Mean Difference (Final Values)|-3.77|STANDARD_ERROR_OF_MEAN|3.6||0.3|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.30
71005665|NCT02096471|141520105|SUPERIORITY|Single Group Study Change in Quality of Life from Baseline amongst those with a Tumor Response|Mean Difference (Final Values)|-3.55|STANDARD_ERROR_OF_MEAN|6.87||0.61|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.61
71005666|NCT02096471|141520105|SUPERIORITY|Single Group Study Change in Baseline amongst those with a Tumor Response|Mean Difference (Final Values)|-13.06|STANDARD_ERROR_OF_MEAN|8.29||0.12|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.12
71005667|NCT02096471|141520105|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-12.98|STANDARD_ERROR_OF_MEAN|6.35||0.05|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only.||Single Group Change from Baseline||||0.05
71005668|NCT02096471|141520105|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|6.66|STANDARD_ERROR_OF_MEAN|5.05||0.19|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.19
71005669|NCT02096471|141520105|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-2.34|STANDARD_ERROR_OF_MEAN|6.46||0.72|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.72
71005670|NCT02096471|141520105|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-6.24|STANDARD_ERROR_OF_MEAN|6.74||0.36|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.36
71005671|NCT02096471|141520105|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|6.37||0.98|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.98
71005672|NCT02096471|141520105|SUPERIORITY|Single Group Study. change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|7.99||0.93|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.93
71005673|NCT02096471|141520105|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-10.97|STANDARD_ERROR_OF_MEAN|8.16||0.19|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.19
71005674|NCT02096471|141520105|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-3.74|STANDARD_ERROR_OF_MEAN|6.58||0.57|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.57
71005675|NCT02096471|141520105|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-4.21|STANDARD_ERROR_OF_MEAN|5.51||0.45|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.45
71005676|NCT02096471|141520105|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-6.27|STANDARD_ERROR_OF_MEAN|5.72||0.28|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.28
71005677|NCT02096471|141520105|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|8.52||0.93|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.93
71005678|NCT02096471|141520105|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|7.53||0.89|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.89
71005679|NCT01610414|141520108|SUPERIORITY|Criterion: The lower limit (LL) of the 95% confidence interval (CI) for overall HZ vaccine efficacy was above 0%.|Vaccine efficacy|68.17|||<|0.0001|TWO_SIDED|95.0|55.56|77.53|||Poisson method|||Vaccine efficacy (VE) was evaluated in the prevention of Herpes Zoster (HZ) in autologous haematopoietic stem cell transplant (HCT) recipients 18 years of agee and older.||77.53|55.56|<0.0001
71005680|NCT02483611|141520135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|149.0|STANDARD_DEVIATION|46.07||0.9651|TWO_SIDED|95.0|88.0|235.0|||ANOVA|||||235|88|0.9651
71005681|NCT02483611|141520135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|145.3|STANDARD_DEVIATION|42.48||0.9651|TWO_SIDED|95.0|78.0|244.0|||ANOVA|||||244|78|0.9651
71005682|NCT02483611|141520135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|147.8|STANDARD_DEVIATION|29.75||0.9651|TWO_SIDED|95.0|105.0|200.0|||ANOVA|||The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. The pharmacodynamic (latency, clinical duration, recovery rate and total duration) and hemodynamic variables (mean arterial pressure (MAP) and HR) were compared between the groups via analysis of variance (ANOVA) followed by the Tukey post-hoc test. The significance level was set at 5%.||200|105|0.9651
71005683|NCT02483611|141520136|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|82.68|||<|0.0001|TWO_SIDED|95.0|72.62|99.27|||Kruskal-Wallis|||||99.27|72.62|<0.0001
71005684|NCT02483611|141520136|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|86.33|||<|0.0001|TWO_SIDED|95.0|71.78|140.6|||Kruskal-Wallis|||||140.60|71.78|<0.0001
71005685|NCT02483611|141520136|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|64.8|||<|0.0001|TWO_SIDED|95.0|40.5|92.9|||Kruskal-Wallis|||||92.90|40.50|<0.0001
71005686|NCT02483611|141520137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.08|STANDARD_DEVIATION|6.49||0.0015|TWO_SIDED|95.0|12.0|32.25|||ANOVA|||||32.25|12.00|0.0015
71044820|NCT01715896|141598807|SUPERIORITY_OR_OTHER||Percent difference|-9.8||||0.156|TWO_SIDED|90.0|-21.1|1.4|||Logit Response Model||P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.|||1.4|-21.1|0.156
71044821|NCT01715896|141598808|SUPERIORITY_OR_OTHER||Percent difference|-11.6||||0.108|TWO_SIDED|90.0|-23.2|0.0|||Logit Response Model||P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.|||0.0|-23.2|0.108
70925338|NCT02677298|141343844|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||This test was performed for the Modified Skindex-16 (GL-QoL) Overall score||||<0.001
71005687|NCT02483611|141520137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.26|STANDARD_DEVIATION|7.69||0.0015|TWO_SIDED|95.0|10.5|39.83|||ANOVA|||||39.83|10.50|0.0015
71005688|NCT02483611|141520137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.53|STANDARD_DEVIATION|1.52||0.0015|TWO_SIDED|95.0|11.0|16.5|||ANOVA|||||16.50|11.00|0.0015
71005689|NCT02483611|141520138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.97|STANDARD_DEVIATION|6.77||0.0003|TWO_SIDED|95.0|19.5|41.5|||ANOVA|||||41.50|19.50|0.0003
71005690|NCT02483611|141520138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.81|STANDARD_DEVIATION|10.97||0.0003|TWO_SIDED|95.0|18.5|49.5|||ANOVA|||||49.50|18.50|0.0003
71005691|NCT02483611|141520138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.51|STANDARD_DEVIATION|3.28||0.0003|TWO_SIDED|95.0|17.5|30.05|||ANOVA|||||30.05|17.50|0.0003
71005692|NCT02483611|141520139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|113.2|STANDARD_DEVIATION|12.16|<|0.0001|TWO_SIDED|95.0|94.87|136.8|||ANOVA|||||136.80|94.87|<0.0001
71044822|NCT01715896|141598809|SUPERIORITY_OR_OTHER||Percent difference|-10.3||||0.208|TWO_SIDED|90.0|-23.7|3.0|||Logit Response Model||P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.|||3.0|-23.7|0.2080
71044823|NCT01715896|141598816|SUPERIORITY_OR_OTHER||Adjusted Mean difference|-7.42||||0.213|TWO_SIDED|90.0|-17.24|2.4|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term.|||2.40|-17.24|0.213
71044824|NCT01715896|141598818|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61||||0.129|TWO_SIDED|90.0|0.36|1.04|||Proportional odds analysis||Odds ratio, 90% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor.|||1.04|0.36|0.129
71005693|NCT02483611|141520139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|120.1|STANDARD_DEVIATION|18.2|<|0.0001|TWO_SIDED|95.0|95.82|163.3|||ANOVA|||||163.30|95.82|<0.0001
71005694|NCT02483611|141520139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|88.19|STANDARD_DEVIATION|16.34|<|0.0001|TWO_SIDED|95.0|58.0|125.2|||ANOVA|||||125.20|58|<0.0001
71005695|NCT02483611|141520140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|120.2|STANDARD_DEVIATION|10.88|<|0.0001|TWO_SIDED|95.0|106.3|140.2|||ANOVA|||||140.20|106.30|<0.0001
71005696|NCT02483611|141520140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|126.7|STANDARD_DEVIATION|14.19|<|0.0001|TWO_SIDED|95.0|106.5|149.4|||ANOVA|||||149.40|106.50|<0.0001
71005697|NCT02483611|141520140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|90.03|STANDARD_DEVIATION|12.78|<|0.0001|TWO_SIDED|95.0|71.75|116.4|||ANOVA|||||116.40|71.75|<0.0001
71005698|NCT02483611|141520141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|94.63|STANDARD_DEVIATION|10.18||0.0527|TWO_SIDED|95.0|70.0|112.0|||ANOVA|||||112.00|70.00|0.0527
71005699|NCT02483611|141520141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|88.75|STANDARD_DEVIATION|10.05||0.0527|TWO_SIDED|95.0|65.0|104.0|||ANOVA|||||104.00|65.00|0.0527
71005700|NCT02483611|141520141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|100.1|STANDARD_DEVIATION|16.62||0.0527|TWO_SIDED|95.0|70.0|140.0|||ANOVA|||||140.00|70.00|0.0527
71005701|NCT02483611|141520142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|87.63|STANDARD_DEVIATION|12.1||0.1996|TWO_SIDED|95.0|60.0|110.0|||ANOVA|||||110.00|60.00|0.1996
71005702|NCT02483611|141520142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|84.69|STANDARD_DEVIATION|11.38||0.1996|TWO_SIDED|95.0|67.0|109.0|||ANOVA|||||109.00|67.00|0.1996
71005703|NCT02483611|141520142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|92.47|STANDARD_DEVIATION|12.3||0.1996|TWO_SIDED|95.0|73.0|112.0|||ANOVA|||||112.00|73.00|0.1996
71005704|NCT02483611|141520143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|75.88|STANDARD_DEVIATION|11.95||0.7145|TWO_SIDED|95.0|58.0|107.0|||ANOVA|||||107.00|58.00|0.7145
71005705|NCT02483611|141520143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|73.88|STANDARD_DEVIATION|9.8||0.7145|TWO_SIDED|95.0|59.0|97.0|||ANOVA|||||97.00|59.00|0.7145
71005706|NCT02483611|141520143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|76.73|STANDARD_DEVIATION|7.48||0.7145|TWO_SIDED|95.0|58.0|86.0|||ANOVA|||||86.00|58.00|0.7145
71005707|NCT02483611|141520144|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|69.0||||0.113|TWO_SIDED|95.0|57.0|96.0|||Kruskal-Wallis|||||96.00|57.00|0.1130
71005708|NCT02483611|141520144|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|63.0||||0.113|TWO_SIDED|95.0|55.0|84.0|||Kruskal-Wallis|||||84.00|55.00|0.1130
71005709|NCT02483611|141520144|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|74.0||||0.113|TWO_SIDED|95.0|59.0|83.0|||Kruskal-Wallis|||||83.00|59.00|0.1130
71005710|NCT02483611|141520145|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|62.5||||0.0731|TWO_SIDED|95.0|58.0|98.0|||Kruskal-Wallis|||||98.00|58.00|0.0731
71005711|NCT02483611|141520145|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|61.5||||0.0731|TWO_SIDED|95.0|55.0|74.0|||Kruskal-Wallis|||||74.00|55.00|0.0731
71005712|NCT02483611|141520145|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|67.0||||0.0731|TWO_SIDED|95.0|56.0|85.0|||Kruskal-Wallis|||||85.00|56.00|0.0731
71005713|NCT02483611|141520146|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|64.5||||0.1002|TWO_SIDED|95.0|60.0|85.0|||Kruskal-Wallis|||||85.00|60.00|0.1002
71005714|NCT02483611|141520146|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|64.0||||0.1002|TWO_SIDED|95.0|56.0|74.0|||Kruskal-Wallis|||||74.00|56.00|0.1002
71044825|NCT01715896|141598819|SUPERIORITY_OR_OTHER||Percent difference|-11.6||||0.108||90.0|-23.2|0.0|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.|DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of golimumab or active responders was less than 5.||0.0|-23.2|0.108
71005715|NCT02483611|141520146|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|69.0||||0.1002|TWO_SIDED|95.0|60.0|90.0|||Kruskal-Wallis|||||90.00|60.00|0.1002
71005716|NCT02483611|141520147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|79.94|STANDARD_DEVIATION|15.79||0.4338|TWO_SIDED|95.0|52.0|109.0|||ANOVA|||||109.00|52.00|0.4338
71005717|NCT02483611|141520147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|77.25|STANDARD_DEVIATION|12.13||0.4338|TWO_SIDED|95.0|55.0|95.0|||ANOVA|||||95.00|55.00|0.4338
71005718|NCT02483611|141520147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|73.67|STANDARD_DEVIATION|11.82||0.4338|TWO_SIDED|95.0|55.0|92.0|||ANOVA|||||92.00|55.00|0.4338
71005719|NCT02483611|141520148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|74.69|STANDARD_DEVIATION|11.76||0.9167|TWO_SIDED|95.0|57.0|99.0|||ANOVA|||||99.00|57.00|0.9167
71044826|NCT01715896|141598819|SUPERIORITY_OR_OTHER||Percent difference|-11.7||||0.145|TWO_SIDED|90.0|-24.8|1.4|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.|The analysis reported DAS28 (CRP) low disease activity response.||1.4|-24.8|0.145
71044827|NCT01715896|141598820|SUPERIORITY_OR_OTHER|||||||0.328|||||||Log Rank|P-value was calculated using the Log rank test.||||||0.328
71044828|NCT01715896|141598821|SUPERIORITY_OR_OTHER|||||||0.003|||||||Weibull model|P-value was calculated using an Weibull model.||||||0.003
71044829|NCT01715896|141598822|SUPERIORITY_OR_OTHER||Percent difference|-1.7||||0.795|TWO_SIDED|90.0|-12.4|9.0|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.|P-value estimated from fisher's exact test when number of golimumab or active responders was less than 5.||9.0|-12.4|0.795
71044830|NCT01715896|141598823|SUPERIORITY_OR_OTHER||Percent difference|-11.7||||0.048|TWO_SIDED|90.0|-21.0|-2.5|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.|||-2.5|-21.0|0.048
71044831|NCT01715896|141598824|SUPERIORITY_OR_OTHER||Percent difference|-11.9||||0.035|TWO_SIDED|90.0|-20.6|-3.1|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.|||-3.1|-20.6|0.035
71044832|NCT01715896|141598825|SUPERIORITY_OR_OTHER||Percent difference|-7.5||||0.061|TWO_SIDED|90.0|-13.6|-1.5|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.|||-1.5|-13.6|0.061
71005720|NCT02483611|141520148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|73.69|STANDARD_DEVIATION|11.18||0.9167|TWO_SIDED|95.0|51.0|96.0|||ANOVA|||||96.00|51.00|0.9167
71005721|NCT02483611|141520148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|75.4|STANDARD_DEVIATION|11.54||0.9167|TWO_SIDED|95.0|53.0|90.0|||ANOVA|||||90.00|53.00|0.9167
71005722|NCT02483611|141520149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|72.94|STANDARD_DEVIATION|10.96||0.8067|TWO_SIDED|95.0|58.0|92.0|||ANOVA|||||92.00|58.00|0.8067
71005723|NCT02483611|141520149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|74.19|STANDARD_DEVIATION|8.65||0.8067|TWO_SIDED|95.0|57.0|86.0|||ANOVA|||||86.00|57.00|0.8067
71005724|NCT02483611|141520149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|75.4|STANDARD_DEVIATION|11.54||0.8067|TWO_SIDED|95.0|53.0|90.0|||ANOVA|||||90.00|53.00|0.8067
71005725|NCT02483611|141520150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|71.94|STANDARD_DEVIATION|10.87||0.1015|TWO_SIDED|95.0|57.0|93.0|||ANOVA|||||93.00|57.00|0.1015
71005726|NCT02483611|141520150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|72.25|STANDARD_DEVIATION|9.78||0.1015|TWO_SIDED|95.0|52.0|89.0|||ANOVA|||||89.00|52.00|0.1015
71005727|NCT02483611|141520150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|65.07|STANDARD_DEVIATION|10.01||0.1015|TWO_SIDED|95.0|44.0|81.0|||ANOVA|||||81.00|44.00|0.1015
71005728|NCT02483611|141520151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|67.56|STANDARD_DEVIATION|10.05||0.3423|TWO_SIDED|95.0|56.0|92.0|||ANOVA|||||92.00|56.00|0.3423
71005729|NCT02483611|141520151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|69.31|STANDARD_DEVIATION|7.73||0.3423|TWO_SIDED|95.0|57.0|83.0|||ANOVA|||||83.00|57.00|0.3423
71005730|NCT02483611|141520151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|64.27|STANDARD_DEVIATION|10.81||0.3423|TWO_SIDED|95.0|41.0|81.0|||ANOVA|||||81.00|41.00|0.3423
71005731|NCT02483611|141520152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|66.5|STANDARD_DEVIATION|10.11||0.6817|TWO_SIDED|95.0|53.0|92.0|||ANOVA|||||92.00|53.00|0.6817
71005732|NCT02483611|141520152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|68.19|STANDARD_DEVIATION|8.4||0.6817|TWO_SIDED|95.0|54.0|82.0|||ANOVA|||||82.00|54.00|0.6817
71044833|NCT01715896|141598826|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.01||||0.993|TWO_SIDED|90.0|-1.33|1.32|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.|Analysis reported for change from baseline in swollen joint count at Day 169.||1.32|-1.33|0.993
71044834|NCT01715896|141598826|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.23||||0.424|TWO_SIDED|90.0|-1.31|3.77|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.|Analysis reported for change from baseline in Tender joint count at Day 169.||3.77|-1.31|0.424
71044835|NCT01715896|141598827|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.89||||0.272|TWO_SIDED|90.0|-2.46|12.24|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.|||12.24|-2.46|0.272
71044836|NCT01715896|141598828|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.46||||0.319|TWO_SIDED|90.0|-2.92|11.84|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.|||11.84|-2.92|0.319
71044837|NCT01715896|141598829|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.16||||0.64|TWO_SIDED|90.0|-0.42|0.74|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.|||0.74|-0.42|0.640
71044838|NCT01715896|141598830|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.18||||0.055|TWO_SIDED|90.0|0.03|0.34|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.|||0.34|0.03|0.055
71044839|NCT01715896|141598831|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.06||||0.752|TWO_SIDED|90.0|0.79|1.41|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis.|||1.41|0.79|0.752
71101769|NCT00835549|141711209|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.0||||||90.0|98.7|105.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||105|98.7|
71005733|NCT02483611|141520152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|65.13|STANDARD_DEVIATION|10.5||0.6817|TWO_SIDED|95.0|47.0|81.0|||ANOVA|||||81.00|47.00|0.6817
71005734|NCT02483611|141520153|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|66.0||||0.0937|TWO_SIDED|95.0|58.0|80.0|||Kruskal-Wallis|||||80.00|58.00|0.0937
71005735|NCT02483611|141520153|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|61.5||||0.0937|TWO_SIDED|95.0|56.0|90.0|||Kruskal-Wallis|||||90.00|56.00|0.0937
71005736|NCT02483611|141520153|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|69.0||||0.0937|TWO_SIDED|95.0|58.0|87.0|||Kruskal-Wallis|||||87.00|58.00|0.0937
71005737|NCT02483611|141520154|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|66.5||||0.1406|TWO_SIDED|95.0|60.0|88.0|||Kruskal-Wallis|||||88.00|60.00|0.1406
71005738|NCT02483611|141520154|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|63.5||||0.1406|TWO_SIDED|95.0|55.0|86.0|||Kruskal-Wallis|||||86.00|55.00|0.1406
71005739|NCT02483611|141520154|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|68.0||||0.1406|TWO_SIDED|95.0|55.0|84.0|||Kruskal-Wallis|||||84.00|55.00|0.1406
71005740|NCT02483611|141520155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|69.25|STANDARD_DEVIATION|6.74||0.0504|TWO_SIDED|95.0|60.0|81.0|||ANOVA|||||81.00|60.00|0.0504
71005741|NCT02483611|141520155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|63.0|STANDARD_DEVIATION|7.62||0.0504|TWO_SIDED|95.0|49.0|79.0|||ANOVA|||||79.00|49.00|0.0504
71005742|NCT02483611|141520155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|69.0|STANDARD_DEVIATION|7.56||0.0504|TWO_SIDED|95.0|58.0|84.0|||ANOVA|||||84.00|58.00|0.0504
71005743|NCT02483611|141520156|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|68.0||||0.0205|TWO_SIDED|95.0|60.0|93.0|||Kruskal-Wallis|||||93.00|60.00|0.0205
71005744|NCT02483611|141520156|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|62.0||||0.0205|TWO_SIDED|95.0|54.0|72.0|||Kruskal-Wallis|||||72.00|54.00|0.0205
71005745|NCT02483611|141520156|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|66.0||||0.0205|TWO_SIDED|95.0|59.0|75.0|||Kruskal-Wallis|||||75.00|59.00|0.0205
71005746|NCT02483611|141520157|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|68.0||||0.3004|TWO_SIDED|95.0|58.0|86.0|||Kruskal-Wallis|||||86.00|58.00|0.3004
71005747|NCT02483611|141520157|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|66.0||||0.3004|TWO_SIDED|95.0|56.0|78.0|||Kruskal-Wallis|||||78.00|56.00|0.3004
71005748|NCT02483611|141520157|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|69.0||||0.3004|TWO_SIDED|95.0|62.0|81.0|||Kruskal-Wallis|||||81.00|62.00|0.3004
71005749|NCT02483611|141520158|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|64.0||||0.0178|TWO_SIDED|95.0|60.0|84.0|||Kruskal-Wallis|||||84.00|60.00|0.0178
71005750|NCT02483611|141520158|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|64.5||||0.0178|TWO_SIDED|95.0|51.0|75.0|||Kruskal-Wallis|||||75.00|51.00|0.0178
71005751|NCT02483611|141520158|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|72.0||||0.0178|TWO_SIDED|95.0|61.0|91.0|||Kruskal-Wallis|||||91.00|61.00|0.0178
71005752|NCT02483611|141520159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|68.67|STANDARD_DEVIATION|8.51||0.8746|TWO_SIDED|95.0|51.0|99.0|||ANOVA|||||99.00|51.00|0.8746
71005753|NCT02483611|141520159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|64.38|STANDARD_DEVIATION|6.96||0.8746|TWO_SIDED|95.0|56.0|82.0|||ANOVA|||||82.00|56.00|0.8746
71101770|NCT00835042|141711210|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|92.5||||||90.0|85.8|99.8|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||99.8|85.8|
71044840|NCT01715896|141598832|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.05||||0.725|TWO_SIDED|90.0|0.84|1.3|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis.|||1.30|0.84|0.725
71044841|NCT03923699|141598835|SUPERIORITY||Risk Ratio (RR)|0.96||||0.41|TWO_SIDED|95.0|0.85|1.08||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.08|0.85|0.41
71044842|NCT03923699|141598836|SUPERIORITY||Risk Ratio (RR)|1.0||||0.92|TWO_SIDED|95.0|0.92|1.1||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.10|0.92|0.92
71044843|NCT03923699|141598837|SUPERIORITY||Risk Ratio (RR)|0.98||||0.68|TWO_SIDED|95.0|0.89|1.09||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.09|0.89|0.68
71044844|NCT03923699|141598838|SUPERIORITY||Risk Ratio (RR)|0.98||||0.42|TWO_SIDED|95.0|0.92|1.05||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.05|0.92|0.42
71044845|NCT03923699|141598839|SUPERIORITY||Risk Ratio (RR)|1.0||||0.99|TWO_SIDED|95.0|0.98|1.02||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.02|0.98|0.99
71044846|NCT03923699|141598840|SUPERIORITY||Risk Ratio (RR)|1.0||||0.95|TWO_SIDED|95.0|0.95|1.05||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.05|0.95|0.95
71044847|NCT03923699|141598841|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.29|TWO_SIDED|95.0|0.0|0.0||Not adjusted for multiple comparisons.|Regression, Linear|||||0.00|-0.00|0.29
71044848|NCT03923699|141598842|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.37|TWO_SIDED|95.0|-0.01|0.0||Not adjusted for multiple comparisons.|Regression, Linear|||||0.00|-0.01|0.37
71044849|NCT03923699|141598843|SUPERIORITY||Risk Ratio (RR)|1.03||||0.3|TWO_SIDED|95.0|0.95|1.13||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.13|0.95|0.30
71044850|NCT03923699|141598844|SUPERIORITY||Risk Ratio (RR)|1.0||||0.85|TWO_SIDED|95.0|0.98|1.02||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.02|0.98|0.85
71101771|NCT00835042|141711211|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.9||||||90.0|92.2|106.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106|92.2|
71101772|NCT00835042|141711212|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.1||||||90.0|92.3|106.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106|92.3|
71044851|NCT03923699|141598845|SUPERIORITY||Risk Ratio (RR)|0.99||||0.51|TWO_SIDED|95.0|0.97|1.02||Not adjusted for multiple comparisons.|Regression, poisson|||||1.02|0.97|0.51
71044852|NCT01746264|141598846|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||P-value for change from baseline to 3 month follow-up.||||0.59
71044853|NCT01746264|141598847|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow up visit.||||<0.001
71044854|NCT01746264|141598848|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||<0.01
71044855|NCT01746264|141598850|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.32
71044856|NCT01746264|141598851|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3-month follow-up.||||0.21
71044857|NCT01746264|141598852|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.02
71044858|NCT01746264|141598853|SUPERIORITY_OR_OTHER|||||||0.0123|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.0123
71044859|NCT01746264|141598854|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.09
71044860|NCT01746264|141598855|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.27
71044861|NCT01746264|141598856|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.18
71044862|NCT01746264|141598857|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.33
71044863|NCT01746264|141598858|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.05
71044864|NCT01746264|141598859|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.41
71044865|NCT01746264|141598860|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.32
71044866|NCT01746264|141598861|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.47
71044867|NCT01173471|141598862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|5.352||0.822|TWO_SIDED|95.0|-15.2|12.6|||Mixed Models Analysis||Difference is (AZD4017 200 mg OD - Placebo OD)|||12.6|-15.2|0.822
71044868|NCT01173471|141598862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|3.516||0.413|TWO_SIDED|95.0|-10.1|4.3|||Mixed Models Analysis||Difference is (AZD4017 400 mg BID - Placebo BID)|||4.3|-10.1|0.413
71044869|NCT01173471|141598864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|1.57||0.758|TWO_SIDED|95.0|-4.8|3.7|||Mixed Models Analysis||Difference is (AZD4017 200 mg OD - Placebo OD)|||3.7|-4.8|0.758
71005754|NCT02483611|141520159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|73.4|STANDARD_DEVIATION|7.94||0.8746|TWO_SIDED|95.0|54.0|80.0|||ANOVA|||||80.00|54.00|0.8746
71005755|NCT02483611|141520160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|67.44|STANDARD_DEVIATION|10.95||0.4195|TWO_SIDED|95.0|47.0|92.0|||ANOVA|||||92.00|47.00|0.4195
71005756|NCT02483611|141520160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|68.38|STANDARD_DEVIATION|9.28||0.4195|TWO_SIDED|95.0|53.0|80.0|||ANOVA|||||80.00|53.00|0.4195
71005757|NCT02483611|141520160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|64.0|STANDARD_DEVIATION|8.23||0.4195|TWO_SIDED|95.0|52.0|80.0|||ANOVA|||||80.00|52.00|0.4195
71005758|NCT02483611|141520161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|65.75|STANDARD_DEVIATION|11.52||0.5796|TWO_SIDED|95.0|47.0|93.0|||ANOVA|||||93.00|47.00|0.5796
71005759|NCT02483611|141520161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|65.75|STANDARD_DEVIATION|10.19||0.5796|TWO_SIDED|95.0|48.0|79.0|||ANOVA|||||79.00|48.00|0.5796
71005760|NCT02483611|141520161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|62.33|STANDARD_DEVIATION|9.26||0.5796|TWO_SIDED|95.0|50.0|79.0|||ANOVA|||||79.00|50.00|0.5796
71044870|NCT01173471|141598864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.909||0.467|TWO_SIDED|95.0|-2.5|1.2|||Mixed Models Analysis||Difference is (AZD4017 400 mg BID - Placebo BID)|||1.2|-2.5|0.467
71005761|NCT02483611|141520162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|66.19|STANDARD_DEVIATION|12.82||0.5351|TWO_SIDED|95.0|45.0|92.0|||ANOVA|||||92.00|45.00|0.5351
71005762|NCT02483611|141520162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|65.31|STANDARD_DEVIATION|10.87||0.5351|TWO_SIDED|95.0|47.0|82.0|||ANOVA|||||82.00|47.00|0.5351
71005763|NCT02483611|141520162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|61.93|STANDARD_DEVIATION|9.0||0.5351|TWO_SIDED|95.0|51.0|79.0|||ANOVA|||||79.00|51.00|0.5351
71005764|NCT02483611|141520163|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|66.5||||0.4988|TWO_SIDED|95.0|42.0|92.0|||Kruskal-Wallis|||||92.00|42.00|0.4988
71005765|NCT02483611|141520163|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|63.0||||0.4988|TWO_SIDED|95.0|50.0|85.0|||Kruskal-Wallis|||||85.00|50.00|0.4988
71005766|NCT02483611|141520163|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|58.0||||0.4988|TWO_SIDED|95.0|51.0|80.0|||Kruskal-Wallis|||||80.00|51.00|0.4988
71044871|NCT03028740|141598865|SUPERIORITY||Percentage Difference|-3.2||||0.2067|TWO_SIDED|95.0|-8.2|1.9||P-value was based on Cochran-Mantel-Haenszel general association test comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage \[2 vs 3\] and presence or absence of Type 2 diabetes mellitus (T2DM) at Baseline).|Cochran-Mantel-Haenszel|||||1.9|-8.2|0.2067
71005767|NCT02483611|141520164|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|66.0||||0.7723|TWO_SIDED|95.0|43.0|89.0|||Kruskal-Wallis|||||89.00|43.00|0.7723
71005768|NCT02483611|141520164|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|61.0||||0.7723|TWO_SIDED|95.0|51.0|82.0|||Kruskal-Wallis|||||82.00|51.00|0.7723
71005769|NCT02483611|141520164|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|61.0||||0.7723|TWO_SIDED|95.0|50.0|78.0|||Kruskal-Wallis|||||78.00|50.00|0.7723
71005770|NCT04223778|141520170|NON_INFERIORITY|Doravirine/Islatravir (DOR/ISL) - Baseline Antiretroviral Therapy (ART). Non-inferiority was concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI was less than 4 percentage points.|Estimated Difference|-1.49|||<|0.001|TWO_SIDED|95.0|-3.44|-0.34|||Miettinen and Nurminen|The Miettinen and Nurminen method was stratified by corrected baseline ART regimen with Cochran-Mantel-Haenszel (CMH) weights.||||-0.34|-3.44|<.001
71005771|NCT04223778|141520171|OTHER|Difference in percentage versus Baseline Antiretroviral Therapy (ART). Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|9.8|||||TWO_SIDED|95.0|3.3|16.3|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|||16.3|3.3|
71005772|NCT04223778|141520172|OTHER|Difference in percentage versus Baseline Antiretroviral Therapy (ART). Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|1.8|||||TWO_SIDED|95.0|0.2|4.0|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|||4.0|0.2|
71005773|NCT04223778|141520173|OTHER|Doravirine/Islatravir (DOR/ISL)- Baseline Antiretroviral Therapy (ART). Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.3|||||TWO_SIDED|95.0|-3.28|3.9|||||The Miettinen and Nurminen method was stratified by corrected baseline ART regimen with Cochran-Mantel-Haenszel (CMH) weights.|HIV-1 RNA \<40 copies/mL||3.90|-3.28|
71005774|NCT04223778|141520173|OTHER|Doravirine/Islatravir (DOR/ISL)- Baseline Antiretroviral Therapy (ART). Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.89|||||TWO_SIDED|95.0|-2.58|4.43|||||The Miettinen and Nurminen method was stratified by corrected baseline ART regimen with Cochran-Mantel-Haenszel (CMH) weights.|HIV-1 RNA \<50 copies/mL||4.43|-2.58|
71005775|NCT04223778|141520176|OTHER|Difference in percentage versus Baseline Antiretroviral Therapy (ART). Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-8.9|||||TWO_SIDED|95.0|-13.4|-4.5|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|||-4.5|-13.4|
71005776|NCT04223778|141520181|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-19.75|||||TWO_SIDED|95.0|-33.07|-6.44|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|Fasting Cholesterol||-6.44|-33.07|
71005777|NCT04223778|141520181|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-1.35|||||TWO_SIDED|95.0|-6.55|3.84|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|Fasting HDL Cholesterol||3.84|-6.55|
71005778|NCT04223778|141520181|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-13.94|||||TWO_SIDED|95.0|-24.69|-3.2|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|Fasting LDL Cholesterol||-3.20|-24.69|
71005779|NCT04223778|141520181|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-17.74|||||TWO_SIDED|95.0|-30.02|-5.46|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|Fasting Non-HDL Cholesterol||-5.46|-30.02|
71101773|NCT00835042|141711213|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|105.0||||||90.0|99.3|111.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||111|99.3|
71101774|NCT00835042|141711214|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.1||||||90.0|96.4|102.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||102|96.4|
71101775|NCT00835042|141711215|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.3||||||90.0|96.7|102.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||102|96.7|
71101776|NCT00835042|141711216|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|91.0||||||90.0|81.8|101.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101|81.8|
71101777|NCT00835042|141711217|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.9||||||90.0|94.6|103.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||103|94.6|
71101778|NCT00835042|141711218|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.0||||||90.0|97.6|108.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||108|97.6|
71101779|NCT00677040|141711244|EQUIVALENCE|t-test to determine if tissue oxygen measurements are equivalent between treated and nontreated breast|t-test|0.35||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.5
71101780|NCT00677040|141711244|OTHER||t-test|0.35||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||.5
71101781|NCT05524948|141711250|OTHER||Adjusted Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.206|<|0.0001|TWO_SIDED|95.0|-1.71|-0.9|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and Baseline overall breath organoleptic score as a covariate.|Adjusted mean difference was calculated as experimental dentifrice minus reference dentifrice.|||-0.90|-1.71|<0.0001
71101782|NCT05524948|141711251|OTHER||Adjusted Mean Difference|-569.64|STANDARD_ERROR_OF_MEAN|97.479|<|0.0001|TWO_SIDED|95.0|-763.11|-376.17|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.||||-376.17|-763.11|<0.0001
71101783|NCT05524948|141711252|OTHER||Adjusted Mean Difference|-418.86|STANDARD_ERROR_OF_MEAN|64.848|<|0.0001|TWO_SIDED|95.0|-547.56|-290.15|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Hydrogen Sulfide|||-290.15|-547.56|<0.0001
71101784|NCT05524948|141711252|OTHER||Adjusted Mean Difference|-108.9|STANDARD_ERROR_OF_MEAN|32.626||0.0012|TWO_SIDED|95.0|-173.66|-44.15|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Methanethiol|||-44.15|-173.66|0.0012
71101785|NCT05524948|141711252|OTHER||Adjusted Mean Difference|-26.17|STANDARD_ERROR_OF_MEAN|22.909||0.2561|TWO_SIDED|95.0|-71.64|19.29|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Dimethyl Sulfide|||19.29|-71.64|0.2561
71101786|NCT05524948|141711253|OTHER||Adjusted Mean Difference|-721.58|STANDARD_ERROR_OF_MEAN|94.584|<|0.0001|TWO_SIDED|95.0|-909.31|-533.86|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.||||-533.86|-909.31|<0.0001
71101787|NCT05524948|141711254|OTHER||Adjusted Mean Difference|-567.89|STANDARD_ERROR_OF_MEAN|68.09|<|0.0001|TWO_SIDED|95.0|-703.03|-432.75|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Hydrogen Sulfide|||-432.75|-703.03|<0.0001
71101788|NCT05524948|141711254|OTHER||Adjusted Mean Difference|-105.39|STANDARD_ERROR_OF_MEAN|24.57|<|0.0001|TWO_SIDED|95.0|-154.15|-56.62|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Methanethiol|||-56.62|-154.15|<0.0001
71044872|NCT03028740|141598865|SUPERIORITY||Odds Ratio (OR)|0.8369|||||TWO_SIDED|95.0|0.6341|1.1044|||||Odds Ratio was based on Mantel-Haenszel estimates comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage \[2 vs 3\] and presence or absence of T2DM at Baseline).|||1.1044|0.6341|
71044873|NCT03028740|141598867|SUPERIORITY||Percentage Difference|-1.7||||0.2827|TWO_SIDED|95.0|-4.8|1.5||P-value was based on Cochran-Mantel-Haenszel general association test comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage \[2 vs 3\] and presence or absence of T2DM at Baseline).|Cochran-Mantel-Haenszel|||||1.5|-4.8|0.2827
71044874|NCT03028740|141598867|SUPERIORITY||Odds Ratio (OR)|0.7844|||||TWO_SIDED|95.0|0.5032|1.2229|||||Odds Ratio was based on Mantel-Haenszel estimates comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage \[2 vs 3\] and presence or absence of T2DM at Baseline).|||1.2229|0.5032|
71044875|NCT03028740|141598868|SUPERIORITY||Percentage Difference|-2.7||||0.4054|TWO_SIDED|95.0|-8.7|3.3||P-value was based on Cochran-Mantel-Haenszel general association test comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage \[2 vs 3\] and presence or absence of T2DM at Baseline).|Cochran-Mantel-Haenszel|||||3.3|-8.7|0.4054
71044876|NCT03028740|141598868|SUPERIORITY||Odds Ratio (OR)|0.8877|||||TWO_SIDED|95.0|0.6709|1.1744|||||Odds Ratio was based on Mantel-Haenszel estimates comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage \[2 vs 3\] and presence or absence of T2DM at Baseline).|||1.1744|0.6709|
71005780|NCT04223778|141520181|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-21.28|||||TWO_SIDED|95.0|-45.51|2.96|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|Fasting Triglycerides||2.96|-45.51|
71005781|NCT04223778|141520182|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-4.17|||||TWO_SIDED|95.0|-10.43|2.09|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Cholesterol||2.09|-10.43|
71005782|NCT04223778|141520182|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.81|||||TWO_SIDED|95.0|-1.46|3.09|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting HDL Cholesterol||3.09|-1.46|
71044877|NCT04060719|141598878|OTHER|No formal hypotheses were tested.|Adjusted Geometric Mean Ratio T/R [%]|10.48|||||TWO_SIDED|90.0|9.74|11.28|||Mixed Models Analysis|Mixed effects model on the logarithmic scale including effects for 'subject' (random) and 'treatment' (fixed).|Confidence intervals were calculated based on the residual error from the mixed effects model. Ratio is calculated as Test/Reference. Intra-individual geometric coefficient of variation (gCV) = 11.8.|Relative bioavailability||11.28|9.74|
71101789|NCT05524948|141711254|OTHER||Adjusted Mean Difference|-38.04|STANDARD_ERROR_OF_MEAN|26.201||0.1498|TWO_SIDED|95.0|-90.04|13.97|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Dimethyl Sulfide|||13.97|-90.04|0.1498
71005783|NCT04223778|141520182|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-3.87|||||TWO_SIDED|95.0|-9.47|1.74|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting LDL Cholesterol||1.74|-9.47|
71005784|NCT04223778|141520182|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-4.92|||||TWO_SIDED|95.0|-11.21|1.38|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Non-HDL Cholesterol||1.38|-11.21|
71005785|NCT04223778|141520182|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|1.65|||||TWO_SIDED|95.0|-16.14|19.43|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Triglycerides||19.43|-16.14|
71005786|NCT04223778|141520183|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|1.05|||||TWO_SIDED|95.0|-7.6|9.7|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Cholesterol||9.70|-7.60|
71005787|NCT04223778|141520183|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-3.16|||||TWO_SIDED|95.0|-6.37|0.05|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting HDL Cholesterol||0.05|-6.37|
71044878|NCT04060719|141598879|OTHER|No formal hypotheses were tested.|Adjusted Geometric Mean Ratio T/R [%]|30.03|||||TWO_SIDED|90.0|25.76|35.02|||Mixed Models Analysis|Mixed effects model on the logarithmic scale including effects for 'subject' (random) and 'treatment' (fixed).|Confidence intervals were calculated based on the residual error from the mixed effects model. Ratio is calculated as Test/Reference. Intra-individual geometric coefficient of variation (gCV) = 25.2.|Relative bioavailability||35.02|25.76|
71044879|NCT04060719|141598880|OTHER|No formal hypotheses were tested.|Adjusted Geometric Mean Ratio T/R [%]|10.39|||||TWO_SIDED|90.0|9.66|11.18|||Mixed Models Analysis|Mixed effects model on the logarithmic scale including effects for 'subject' (random) and 'treatment' (fixed).|Confidence intervals were calculated based on the residual error from the mixed effects model. Ratio is calculated as Test/Reference. Intra-individual geometric coefficient of variation (gCV) = 11.8.|Relative bioavailability||11.18|9.66|
71044880|NCT04578886|141598881|SUPERIORITY||Mean Difference (Final Values)|3.4|STANDARD_DEVIATION|3.7||0.22|TWO_SIDED|95.0|2.3|4.4|||t-test, 2 sided|||||4.4|2.3|0.22
71101790|NCT05524948|141711255|OTHER||Adjusted Mean Difference|-2.17|STANDARD_ERROR_OF_MEAN|0.204|<|0.0001|TWO_SIDED|95.0|-2.58|-1.77|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and Baseline overall breath organoleptic score as a covariate.|Adjusted mean difference was calculated as experimental dentifrice minus reference dentifrice.|||-1.77|-2.58|<0.0001
71005788|NCT04223778|141520183|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|4.38|||||TWO_SIDED|95.0|-2.27|11.03|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting LDL Cholesterol||11.03|-2.27|
71005789|NCT04223778|141520183|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|3.63|||||TWO_SIDED|95.0|-3.93|11.19|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Non-HDL Cholesterol||11.19|-3.93|
71005790|NCT04223778|141520183|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-1.79|||||TWO_SIDED|95.0|-15.89|12.31|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Triglycerides||12.31|-15.89|
71005791|NCT04223778|141520184|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-18.41|||||TWO_SIDED|95.0|-32.05|-4.76|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Cholesterol||-4.76|-32.05|
71005792|NCT04223778|141520184|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.01|||||TWO_SIDED|95.0|-5.06|5.08|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting HDL Cholesterol||5.08|-5.06|
71005793|NCT04223778|141520184|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-14.12|||||TWO_SIDED|95.0|-25.81|-2.43|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting LDL Cholesterol||-2.43|-25.81|
71005794|NCT04223778|141520184|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-18.23|||||TWO_SIDED|95.0|-30.45|-6.0|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Non-HDL Cholesterol||-6.00|-30.45|
71005795|NCT04223778|141520184|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-27.79|||||TWO_SIDED|95.0|-51.08|-4.49|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Triglycerides||-4.49|-51.08|
71005796|NCT04223778|141520184|SUPERIORITY|Treatment Difference vs Baseline ART. Superiority will be concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI is less than 0 percentage points.|Mean Difference (Net)|-14.12||||0.0094|TWO_SIDED|95.0|-27.56|-0.68||The significance level in ANCOVA model was 0.02497/2=0.012485. The p-value is statistically significant if it is \<0.02497/2=0.012485.|ANCOVA|||Fasting LDL Cholesterol - Multiplicity Adjusted|The multiplicity adjusted 95% CIs for treatment difference were calculated from ANCOVA models with terms for baseline measurement and treatment.|-0.68|-27.56|0.0094
71005797|NCT04223778|141520184|SUPERIORITY|Treatment Difference vs Baseline ART. Superiority will be concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI is less than 0 percentage points.|Mean Difference (Net)|-18.23||||0.0021|TWO_SIDED|95.0|-32.28|-4.17||The significance level in ANCOVA model was 0.02497/2=0.012485. The p-value is statistically significant if it is \<0.02497/2=0.012485.|ANCOVA|||Fasting Non-HDL Cholesterol - Multiplicity Adjusted|The multiplicity adjusted 95% CIs for treatment difference were calculated from ANCOVA models with terms for baseline measurement and treatment.|-4.17|-32.28|0.0021
71005798|NCT04223778|141520185|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-0.04|||||TWO_SIDED|95.0|-6.26|6.18|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Cholesterol||6.18|-6.26|
71005799|NCT04223778|141520185|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.35|||||TWO_SIDED|95.0|-1.84|2.54|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting HDL Cholesterol||2.54|-1.84|
71005800|NCT04223778|141520185|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.64|||||TWO_SIDED|95.0|-4.83|6.11|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting LDL Cholesterol||6.11|-4.83|
71005801|NCT04223778|141520185|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-0.49|||||TWO_SIDED|95.0|-6.81|5.83|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Non-HDL Cholesterol||5.83|-6.81|
71005802|NCT04223778|141520185|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-5.45|||||TWO_SIDED|95.0|-20.46|9.57|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Triglycerides||9.57|-20.46|
71008651|NCT02055976|141525237|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.834|STANDARD_ERROR_OF_MEAN|0.7442||0.133|TWO_SIDED|95.0|-0.6451|2.313|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||2.3130|-0.6451|0.133
71008652|NCT02055976|141525238|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.0813|STANDARD_ERROR_OF_MEAN|2.0411||0.155|TWO_SIDED|95.0|-1.973|6.1356|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||6.1356|-1.9730|0.155
71008653|NCT02055976|141525238|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.2608|STANDARD_ERROR_OF_MEAN|2.0965||0.062|TWO_SIDED|95.0|-0.9035|7.425|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.4250|-0.9035|0.062
71005803|NCT04223778|141520185|SUPERIORITY|Treatment Difference vs Baseline ART. Superiority will be concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI is less than 0 percentage points.|Mean Difference (Net)|0.64||||0.4093|TWO_SIDED|95.0|-5.63|6.9||The significance level in ANCOVA model was 0.02497/2=0.012485. The p-value is statistically significant if it is \<0.02497/2=0.012485.|ANCOVA|||Fasting LDL Cholesterol - Multiplicity Adjusted|The multiplicity adjusted 95% CIs for treatment difference were calculated from ANCOVA models with terms for baseline measurement and treatment.|6.90|-5.63|0.4093
71005804|NCT04223778|141520185|SUPERIORITY|Treatment Difference vs Baseline ART. Superiority will be concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI is less than 0 percentage points.|Mean Difference (Net)|-0.49||||0.4397|TWO_SIDED|95.0|-7.72|6.75||The significance level in ANCOVA model was 0.02497/2=0.012485. The p-value is statistically significant if it is \<0.02497/2=0.012485.|ANCOVA|||Fasting Non-HDL Cholesterol - Multiplicity Adjusted|The multiplicity adjusted 95% CIs for treatment difference were calculated from ANCOVA models with terms for baseline measurement and treatment.|6.75|-7.72|0.4397
71005805|NCT04223778|141520186|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|2.31|||||TWO_SIDED|95.0|-5.54|10.17|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Cholesterol||10.17|-5.54|
71005806|NCT04223778|141520186|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-2.52|||||TWO_SIDED|95.0|-5.69|0.65|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting HDL Cholesterol||0.65|-5.69|
71101791|NCT05524948|141711256|OTHER||Adjusted Mean Difference|-396.96|STANDARD_ERROR_OF_MEAN|95.541|<|0.0001|TWO_SIDED|95.0|-586.51|-207.41|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.||||-207.41|-586.51|<0.0001
71101792|NCT05524948|141711257|OTHER||Adjusted Mean Difference|-341.37|STANDARD_ERROR_OF_MEAN|72.446|<|0.0001|TWO_SIDED|95.0|-485.1|-197.64|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Hydrogen Sulfide|||-197.64|-485.10|<0.0001
71101793|NCT05524948|141711257|OTHER||Adjusted Mean Difference|-74.15|STANDARD_ERROR_OF_MEAN|20.905||0.0006|TWO_SIDED|95.0|-115.62|-32.68|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Methanethiol|||-32.68|-115.62|0.0006
71101794|NCT05524948|141711257|OTHER||Adjusted Mean Difference|27.98|STANDARD_ERROR_OF_MEAN|25.942||0.2834|TWO_SIDED|95.0|-23.49|79.45|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Dimethyl Sulfide|||79.45|-23.49|0.2834
71005807|NCT04223778|141520186|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|2.34|||||TWO_SIDED|95.0|-3.73|8.42|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting LDL Cholesterol||8.42|-3.73|
71005808|NCT04223778|141520186|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|3.97|||||TWO_SIDED|95.0|-2.63|10.56|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Non-HDL Cholesterol||10.56|-2.63|
71005809|NCT04223778|141520186|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|10.5|||||TWO_SIDED|95.0|-3.97|24.96|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Triglycerides||24.96|-3.97|
71005810|NCT04223778|141520187|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.44|||||TWO_SIDED|95.0|-0.59|1.46|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|||1.46|-0.59|
71005811|NCT01569568|141520202|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||This is an uncorrected p-value. A priori threshold is 0.05.|t-test, 2 sided|||The null hypothesis predicts that the concentration of glutamine is the same for controls and OTCD patients in PCGM.||||0.001
71005812|NCT01569568|141520202|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold is 0.05.|t-test, 2 sided|||The null hypothesis predicts that the concentration of myoinositol is the same for controls and OTCD patients in PCGM.||||0.011
71005813|NCT01569568|141520202|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||This is an uncorrected p-value. A priori threshold was 0.05.|t-test, 2 sided|||The null hypothesis predicts that the concentration of glutamine is the same for controls and OTCD patients in PWM.||||0.004
71005814|NCT01569568|141520202|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046|TWO_SIDED|||||This is an uncorrected p-value. A priori threshold was 0.05.|t-test, 2 sided|||The null hypothesis predicts that the concentration of myoinositol is the same for controls and OTCD patients in PWM.||||0.046
71005815|NCT01569568|141520203|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Our a priori threshold for statistical significance was 0.05.|ANOVA|We ran a 2 (Group) x 6 (ROI Pair) ANOVA to assess functional connectivity between the nodes of the DMN, using age as a covariate.||The null hypothesis states predicts no main effects of Group, ROI pair, or Age, suggesting that the connectivity between all DMN nodes is the same across groups.||||<0.001
71005816|NCT01569568|141520203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC/mPFC node and the left IPL node does not differ between groups.||||0.024
71005817|NCT01569568|141520203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold is 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC/mPFC node and the PCC node does not differ between groups.||||0.040
71005818|NCT01569568|141520203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC/mPFC node and the right IPL node does not differ between groups.||||0.008
71005819|NCT01569568|141520203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the left IPL node and the right IPL node does not differ between groups.||||0.470
71005820|NCT01569568|141520203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.829|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the PCC node and the left IPL node does not differ between groups.||||0.829
71005821|NCT01569568|141520203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.801|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the PCC node and the right IPL node does not differ between groups.||||0.801
71005822|NCT01569568|141520203|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Our a priori threshold for statistical significance was 0.05.|ANOVA|We ran a 2 (Group) x 6 (ROI Pair) ANOVA to assess functional connectivity between the nodes of the SMN, using age as a covariate.||The null hypothesis states predicts no main effects of Group, ROI pair, or Age, suggesting that the connectivity between all SMN nodes is the same across groups.||||<0.001
71005823|NCT01569568|141520203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC node and the left aI/fO node does not differ between groups.||||0.550
71005824|NCT01569568|141520203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.113|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC node and the left SFG node does not differ between groups.||||0.113
71044881|NCT04578886|141598881|SUPERIORITY||Risk Ratio (RR)|1.3307||||0.015|TWO_SIDED|95.0|1.0571|1.6751||unadjusted for covariates|Regression, Linear|||"Null Hypothesis: The administration of guanfacine in critically ill patients in the intensive unit has no effect on the duration of delirium.~Continuous variables will be summarized using sample mean and sample variance whereas categorical variables will be summarized as proportions. Logistic regression models will examine whether age, gender, or comorbities associated with incidence of delirium when Guanfacine is administered."||1.6751|1.0571|0.0150
71044882|NCT03053583|141598976|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|||Posthoc analysis of POGO scores were compared using the Kruskall Wallis test with Mann-WHitney test for pairwise comparisons||||<0.05
71101795|NCT05524948|141711258|OTHER||Adjusted Mean Difference|-1.55|STANDARD_ERROR_OF_MEAN|0.138|<|0.0001|TWO_SIDED|95.0|-1.83|-1.28|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and Baseline overall breath organoleptic score as a covariate.|Adjusted mean difference was calculated as the experimental dentifrice minus the reference dentifrice.|||-1.28|-1.83|<0.0001
71101796|NCT05524948|141711259|OTHER||Adjusted Mean Difference|-322.75|STANDARD_ERROR_OF_MEAN|67.778|<|0.0001|TWO_SIDED|95.0|-457.27|-188.23|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.||||-188.23|-457.27|<0.0001
71101797|NCT05524948|141711260|OTHER||Adjusted Mean Difference|-250.33|STANDARD_ERROR_OF_MEAN|42.838|<|0.0001|TWO_SIDED|95.0|-335.35|-165.3|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Hydrogen Sulfide|||-165.30|-335.35|<0.0001
71005825|NCT01569568|141520203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC node and the right aI/fO node does not differ between groups.||||0.039
71005826|NCT01569568|141520203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC node and the right SFG node does not differ between groups.||||0.005
71005827|NCT01569568|141520203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.426|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the left aI/fO and the left SFG node does not differ between groups.||||0.426
71005828|NCT01569568|141520203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.256|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the left aI/fO node and the right aI/fO node does not differ between groups.||||0.256
71005829|NCT01569568|141520203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.853|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the left aI/fO and the right SFG node does not differ between groups.||||0.853
71005830|NCT01569568|141520203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the right aI/fO node and the left SFG node does not differ between groups.||||0.003
71005831|NCT01569568|141520203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the right aI/fO node and the right SFG node does not differ between groups.||||0.023
71005832|NCT01569568|141520205|SUPERIORITY_OR_OTHER_LEGACY|||||||0.929|TWO_SIDED|||||Equal variance is not assumed. Two tailed t-test WASI verbal IQ between cases and controls|t-test, 2 sided|||||||.929
71005833|NCT01569568|141520205|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||Equal variance not assumed. Comparison WASI performance IQ cases and controls|t-test, 2 sided|||||||.002
71005834|NCT01569568|141520205|SUPERIORITY_OR_OTHER_LEGACY|||||||0.094|TWO_SIDED|||||Equal variance not assumed. Comparison of WASI full IQ cases and controls|t-test, 2 sided|||||||.094
71005835|NCT01569568|141520205|SUPERIORITY_OR_OTHER_LEGACY|||||||0.853|TWO_SIDED|||||Equal variance not assumed. Comparison of CTMT global composite score between cases and controls|t-test, 2 sided|||||||.853
71005836|NCT01569568|141520205|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||Equal variance not assumed. Comparison of BRIEF BRI cases and controls|t-test, 2 sided|||||||.001
71005837|NCT01569568|141520205|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Equal variances not assumed. Comparison of BRIEF MI cases and controls|t-test, 2 sided|||||||<.001
71005838|NCT01569568|141520205|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Equal variances not assumed. Comparison of BRIEF GEC between cases and controls.|t-test, 2 sided|||||||<0.001
71005839|NCT00887822|141520220|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.8636|TWO_SIDED|95.0|0.75|1.41|||Log Rank|The difference in distribution of survival between the two treatment arms was tested with a two-sided unstratified log-rank test.|The hazard ratio between the two treatment arms was estimated with a univariate Cox's proportional hazards model.|||1.41|0.75|0.8636
71005840|NCT00887822|141520222|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.4709|TWO_SIDED|95.0|0.66|1.21|||Log Rank|The difference in distribution of progression-free survival between the two treatment arms was tested with a two-sided unstratified log-rank test.|The hazard ratio between the two treatment arms was estimated with a univariate Cox's proportional hazards model.|||1.21|0.66|0.4709
71044883|NCT03005067|141598979|OTHER||Mean Difference (Net)|0.137||||0.516|TWO_SIDED|95.0|-0.279|0.553||P-value was based on the Wald statistic Chi-Square test, from an ANCOVA model with treatment, center, and Day 1 dosing time stratification as factors and baseline NSS (Day 1 prior to the first dose) as a covariate.|ANCOVA||Difference of LS mean is 1146A Formulation Nasal Spray - Placebo Nasal Spray. 95% CI is for difference of LS means.|||0.553|-0.279|0.516
71044884|NCT02296853|141598987|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|54.04|||||TWO_SIDED|90.0|41.98|69.56|||||Here, GLSM is geometric least square mean.|TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||69.56|41.98|
71044885|NCT02296853|141598987|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|63.06|||||TWO_SIDED|90.0|42.9|92.7||||||TFV: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||92.70|42.90|
71044886|NCT02296853|141598987|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|94.42|||||TWO_SIDED|90.0|72.48|122.99||||||Free (unbound) TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||122.99|72.48|
71005841|NCT00887822|141520224|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.3685|TWO_SIDED|95.0|0.58|1.22|||Log Rank|The difference in distribution of progression-free survival between the two treatment arms was tested with a two-sided unstratified log-rank test.|The hazard ratio between the two treatment arms was estimated with a univariate Cox's proportional hazards model.|||1.22|0.58|0.3685
71005842|NCT00887822|141520226|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.8589|TWO_SIDED|95.0|0.67|1.41|||Log Rank|The difference in distribution of disease progression between the two treatment arms was tested with a two-sided unstratified log-rank test.|The hazard ratio between the two treatment arms was estimated with a univariate Cox's proportional hazards model.|||1.41|0.67|0.8589
71005843|NCT00887822|141520227|SUPERIORITY_OR_OTHER||Difference in Response Rates|7.02||||0.348|TWO_SIDED|95.0|-8.3|22.4|||Chi-squared||Approximate 95% CI for difference of two rates using Hauck-Anderson method|||22.4|-8.3|0.3480
71005844|NCT00887822|141520228|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53||||0.0462|TWO_SIDED|95.0|0.29|1.0|||Log Rank|The difference in distribution of response between the two treatment arms was tested with a two-sided unstratified log-rank test.|The hazard ratio between the two treatment arms was estimated with a univariate Cox's proportional hazards model.|||1.00|0.29|0.0462
71005845|NCT00887822|141520229|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|0.45||||0.9426|TWO_SIDED|95.0|-12.4|13.3|||Chi-squared||Approximate 95% CI for difference of two rates using Hauck-Anderson method|||13.3|-12.4|0.9426
70925339|NCT02677298|141343844|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test was performed for the FACE-Q Appraisal of Lines Between Eyebrows Scale - Change from Baseline at Week 4||||<0.001
71005846|NCT02045979|141520232|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 percent (%).|ratio of the geometric means|108.62|||||TWO_SIDED|90.0|98.5|119.79|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||119.79|98.50|
71005847|NCT02045979|141520232|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|101.27|||||TWO_SIDED|90.0|92.45|110.94|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||110.94|92.45|
71044887|NCT02296853|141598988|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|45.1|||||TWO_SIDED|90.0|31.66|64.25||||||TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||64.25|31.66|
71044888|NCT02296853|141598988|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|89.88|||||TWO_SIDED|90.0|64.77|124.72||||||TFV: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||124.72|64.77|
70925340|NCT02677298|141343844|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test was performed for the FACE-Q Age Appraisal VAS score||||<0.001
70925341|NCT03210272|141343883|OTHER||Geometric Mean Ratio T/R (%)|155.6|||||TWO_SIDED|90.0|130.66|185.3|||||intra-individual gCV (%) = 18.1|The statistical model to assess relative bioavailability in the FE part was an analysis of variance (ANOVA) on the ln-transformed parameters AUC and Cmax including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'||185.30|130.66|
71005848|NCT02045979|141520232|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|94.02|||||TWO_SIDED|90.0|86.01|102.78|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||102.78|86.01|
71005849|NCT02045979|141520233|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|107.32|||||TWO_SIDED|90.0|98.49|116.94|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||116.94|98.49|
71005850|NCT02045979|141520233|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|99.93|||||TWO_SIDED|90.0|92.15|108.37|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||108.37|92.15|
71005851|NCT02045979|141520233|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|93.66|||||TWO_SIDED|90.0|86.76|101.11|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||101.11|86.76|
71005852|NCT02045979|141520234|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|100.85|||||TWO_SIDED|90.0|95.15|106.88|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||106.88|95.15|
71005853|NCT02045979|141520234|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|96.39|||||TWO_SIDED|90.0|91.06|102.03|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||102.03|91.06|
71044889|NCT02296853|141598988|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|82.16|||||TWO_SIDED|90.0|56.58|119.31||"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."||||Free (unbound) TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||119.31|56.58|
71044890|NCT02296853|141598989|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|51.2|||||TWO_SIDED|90.0|40.11|65.36||||||TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||65.36|40.11|
71005854|NCT02045979|141520234|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|95.93|||||TWO_SIDED|90.0|90.83|101.33|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||101.33|90.83|
71005855|NCT02045979|141520235|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% Confidence Interval (CI) for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|98.3|||||TWO_SIDED|90.0|91.54|105.55|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||105.55|91.54|
71005856|NCT02045979|141520235|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|96.05|||||TWO_SIDED|90.0|89.27|103.36|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||103.36|89.27|
71005857|NCT02045979|141520235|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|98.11|||||TWO_SIDED|90.0|91.42|105.27|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||105.27|91.42|
71005858|NCT02045979|141520236|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|99.61|||||TWO_SIDED|90.0|93.66|105.94|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||105.94|93.66|
71005859|NCT02045979|141520236|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|97.19|||||TWO_SIDED|90.0|91.39|103.35|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||103.35|91.39|
71005860|NCT02045979|141520236|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|97.97|||||TWO_SIDED|90.0|92.58|103.68|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||103.68|92.58|
71005861|NCT02045979|141520237|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|101.23|||||TWO_SIDED|90.0|95.45|107.36|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||107.36|95.45|
71044891|NCT02296853|141598989|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|62.04|||||TWO_SIDED|90.0|41.92|91.82||||||TFV: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||91.82|41.92|
71044892|NCT02296853|141598989|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|93.28|||||TWO_SIDED|90.0|72.62|119.8||||||Free (unbound) TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||119.8|72.62|
71044893|NCT03233958|141598992|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|-0.24|||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
71044894|NCT03233958|141598993|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|5.55|||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
71044895|NCT03233958|141598994|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|-0.54||||0.002|TWO_SIDED||||||ANOVA|||||||0.002
71044896|NCT03233958|141598995|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|-0.18||||0.076|TWO_SIDED||||||ANOVA|||||||0.076
71005862|NCT02045979|141520237|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|98.83|||||TWO_SIDED|90.0|93.27|104.72|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||104.72|93.27|
71005863|NCT02045979|141520237|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|98.01|||||TWO_SIDED|90.0|93.15|103.11|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||103.11|93.15|
71044897|NCT03233958|141598996|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|-0.51||||0.147|TWO_SIDED||||||ANOVA|||||||0.147
71044898|NCT03233958|141598997|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|1.07||||0.197|TWO_SIDED||||||ANOVA|||||||0.197
71044899|NCT03233958|141598998|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|1.25|||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
71005864|NCT02045979|141520238|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|103.68|||||TWO_SIDED|90.0|97.47|110.29|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||110.29|97.47|
71005865|NCT02045979|141520238|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|100.16|||||TWO_SIDED|90.0|94.37|106.29|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||106.29|94.37|
71005866|NCT02045979|141520238|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|97.02|||||TWO_SIDED|90.0|92.07|102.24|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||102.24|92.07|
71005867|NCT02045979|141520239|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|106.57|||||TWO_SIDED|90.0|99.07|114.63|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||114.63|99.07|
71005868|NCT02045979|141520239|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|100.94|||||TWO_SIDED|90.0|94.24|108.12|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||108.12|94.24|
71005869|NCT02045979|141520239|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|95.37|||||TWO_SIDED|90.0|89.53|101.6|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||101.60|89.53|
71005870|NCT02045979|141520240|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|108.7|||||TWO_SIDED|90.0|98.54|119.9|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||119.90|98.54|
71005871|NCT02045979|141520240|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|101.36|||||TWO_SIDED|90.0|92.51|111.05|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||111.05|92.51|
71005872|NCT02045979|141520240|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|94.04|||||TWO_SIDED|90.0|86.01|102.82|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||102.82|86.01|
71005873|NCT02425891|141520242|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.8||||0.0025|TWO_SIDED|95.0|0.69|0.92|||Log Rank|||||0.92|0.69|0.0025
71005874|NCT02425891|141520243|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.49|0.78|||Log Rank|||||0.78|0.49|<.0001
71005875|NCT02425891|141520244|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.87||||0.077|TWO_SIDED|95.0|0.75|1.02|||Log Rank|||||1.02|0.75|0.0770
71005876|NCT02425891|141520245|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.67||||0.0016|TWO_SIDED|95.0|0.53|0.86|||Log Rank|||||0.86|0.53|0.0016
71044900|NCT04844021|141599043|OTHER|We used a multiple hypothesis testing framework to evaluate the effectiveness of Nudge+ vs. Nudge, considering: 1) Nudge+ is more effective than Nudge by over 10 percentage points (PP); 2) Nudge+ is as effective as Nudge, with a difference of no greater than 10 PP in either direction; and 3) Nudge+ is less effective than Nudge by over 10 PP. The 10 PP margin was selected based on discussions with health system leaders and previous studies to ensure the differences were clinically meaningful.|Marginal probability|0.22|||||TWO_SIDED|95.0|0.13|0.31||If the 95% confidence interval for the risk difference did not contain any values within a region (Nudge+ superior, equivalence, Nudge+ inferior), that region could be rejected.||||The primary analysis involved fitting generalized estimating equations (GEE) with a binomial distribution and logit link to estimate reach (primary endpoint) for Nudge and Nudge+ along with the risk difference between conditions.||0.31|0.13|
71005877|NCT02425891|141520246|SUPERIORITY|Stratified Analysis|Difference in Overall Response Rates|10.12||||0.0021|TWO_SIDED|95.0|3.4|16.84|||Cochran-Mantel-Haenszel|||||16.84|3.40|0.0021
71005878|NCT02425891|141520247|SUPERIORITY|Stratified Analysis|Difference in Overall Response Rates|16.3||||0.0016|TWO_SIDED|95.0|5.67|26.92|||Cochran-Mantel-Haenszel|||||26.92|5.67|0.0016
71005879|NCT02425891|141520248|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.78||||0.0285|TWO_SIDED|95.0|0.63|0.98|||Log Rank|||||0.98|0.63|0.0285
71005880|NCT02425891|141520249|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.6||||0.0047|TWO_SIDED|95.0|0.43|0.86|||Log Rank|||||0.86|0.43|0.0047
71005881|NCT02425891|141520250|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.98||||0.8078|TWO_SIDED|95.0|0.81|1.18|||Log Rank|||||1.18|0.81|0.8078
71005882|NCT02425891|141520251|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.98||||0.8879|TWO_SIDED|95.0|0.73|1.31|||Log Rank|||||1.31|0.73|0.8879
71005883|NCT01599585|141520268|NON_INFERIORITY_OR_EQUIVALENCE|One tailed test at .05a = .05 margin was set at standardized difference of .50|Regression, Beta|0.4|||||TWO_SIDED|90.0|0.12|0.68||||||||.68|.12|
71005884|NCT01599585|141520280|NON_INFERIORITY_OR_EQUIVALENCE|One tailed test at .05a = .05 margin was set at standardized difference of .50|Regression, Beta|0.47|||||TWO_SIDED|90.0|0.16|0.78||||||||.78|.16|
71005885|NCT01029691|141520306|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||unadjusted systolic blood pressure at baseline between groups||||0.45
71005886|NCT01029691|141520306|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||Unadjusted diastolic blood pressure at baseline between groups||||0.66
71044901|NCT04844021|141599043|OTHER|We used a multiple hypothesis testing framework to evaluate the effectiveness of Nudge+ vs. Nudge, considering: 1) Nudge+ is more effective than Nudge by over 10 percentage points (PP); 2) Nudge+ is as effective as Nudge, with a difference of no greater than 10 PP in either direction; and 3) Nudge+ is less effective than Nudge by over 10 PP. The 10 PP margin was selected based on discussions with health system leaders and previous studies to ensure the differences were clinically meaningful.|Marginal probability|0.49|||||TWO_SIDED|95.0|0.37|0.61||If the 95% confidence interval for the risk difference did not contain any values within a region (Nudge+ superior, equivalence, Nudge+ inferior), that region could be rejected.||||The primary analysis involved fitting generalized estimating equations (GEE) with a binomial distribution and logit link to estimate reach (primary endpoint) for Nudge and Nudge+ along with the risk difference between conditions.||0.61|0.37|
71044902|NCT01258101|141599049|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to Arms Peginterferon/Ribavirin 800 mg (16 weeks) and Peginterferon/Ribavirin 400 mg (16 weeks).|Risk Difference (RD)|32.0|||||TWO_SIDED|95.0|10.5|53.5||||||||53.5|10.5|
71044903|NCT01258101|141599049|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 400 mg (24 weeks).|Risk Difference (RD)|-3.2|||||TWO_SIDED|95.0|-14.0|7.6||||||||7.6|-14.0|
71044904|NCT01258101|141599049|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 800 mg (16 weeks).|Risk Difference (RD)|7.2|||||TWO_SIDED|95.0|-4.7|19.1||||||||19.1|-4.7|
71044905|NCT01258101|141599049|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 400 mg (16 weeks).|Risk Difference (RD)|-21.1|||||TWO_SIDED|95.0|-42.2|-0.1||||||||-0.1|-42.2|
71044906|NCT01258101|141599051|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (16 weeks) and Peginterferon/Ribavirin 400 mg (16 weeks).|Risk Difference (RD)|-0.4|||||TWO_SIDED|95.0|-1.0|0.2||||||||0.2|-1.0|
71044907|NCT01258101|141599051|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 400 mg (24 weeks).|Risk Difference (RD)|-2.6|||||TWO_SIDED|95.0|-6.4|1.3||||||||1.3|-6.4|
71044908|NCT01258101|141599051|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 800 mg (16 weeks).|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-1.4|1.4||||||||1.4|-1.4|
71044909|NCT01258101|141599051|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 400 mg (16 weeks).|Risk Difference (RD)|0.6|||||TWO_SIDED|95.0|-0.5|1.7||||||||1.7|-0.5|
71044910|NCT01258101|141599059|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.629||||0.2667|TWO_SIDED||||||Regression, Cox|||||||0.2667
71044911|NCT01258101|141599059|SUPERIORITY_OR_OTHER|||||||0.9999|||||||Regression, Cox|||||||0.9999
71044912|NCT01258101|141599059|SUPERIORITY_OR_OTHER|||||||0.9891|||||||Regression, Cox|||||||0.9891
71044913|NCT02243293|141599087|NON_INFERIORITY|The non-inferiority of the rate of sustained virologic response at 12 weeks after treatment as compared to historical control (in genotype 2 (GT2) DAA-naive participants in Part 4, arm S) was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 89% to achieve noninferiority.|Percentage of Participants|98.5|||||TWO_SIDED|95.0|96.5|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution.|||100.0|96.5|
71044914|NCT00118378|141599123|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||ANCOVA|||||||< 0.001
71044915|NCT00118378|141599124|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.001
71044916|NCT00118378|141599125|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED|95.0|||||ANOVA|||Week 4 CD4 cell count||||.150
71044917|NCT00118378|141599126|SUPERIORITY_OR_OTHER|||||||0.459|TWO_SIDED|95.0|||||ANOVA|||||||.459
71044918|NCT01117337|141599153|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Fisher Exact|||||||0.2
71005887|NCT01029691|141520306|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||Unadjusted systolic blood pressure at week 1||||0.61
71005888|NCT01029691|141520306|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||Unadjusted diastolic blood pressure at week 1||||0.75
71005889|NCT01029691|141520307|SUPERIORITY|||||||0.085|||||||Chi-squared|||||||0.085
71005890|NCT01029691|141520308|SUPERIORITY|||||||0.012||||||Unadjusted|t-test, 2 sided|||||||0.012
71044919|NCT01117337|141599154|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Fisher Exact|||||||0.56
71044920|NCT03575871|141599155|SUPERIORITY||Difference in Percentage|19.3||||0.0008|TWO_SIDED|95.0|9.6|29.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and confidence interval (CI) for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||29.0|9.6|0.0008
71044921|NCT03575871|141599155|SUPERIORITY||Difference in Percentage|28.7|||<|0.0001|TWO_SIDED|95.0|18.6|38.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.8|18.6|<0.0001
71101798|NCT05524948|141711260|OTHER||Adjusted Mean Difference|-45.53|STANDARD_ERROR_OF_MEAN|23.439||0.055|TWO_SIDED|95.0|-92.05|0.99|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Methanethiol|||0.99|-92.05|0.0550
71005891|NCT01029691|141520312|SUPERIORITY|||||||0.4|||||||Fisher Exact|||||||0.4
71005892|NCT00137267|141520355|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71005893|NCT00137267|141520356|SUPERIORITY_OR_OTHER|||||||0.152|TWO_SIDED||||||Chi-squared|||||||0.152
71005894|NCT00853112|141520370|SUPERIORITY_OR_OTHER||Predicted Mean Difference|-115.0|STANDARD_DEVIATION|98.36||0.12|TWO_SIDED|95.0|-371.5|-1.1|||Bayesian 4-parameter Emax model|||Change over 4 hours post-dose: The Bayesian 4-parameter Emax model was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of \>=240 dyne\*s\*m\^2/cm\^5 from placebo. The predicted means and SD were the posterior means and standard deviation (SD) from the Bayesian analysis.||-1.1|-371.5|0.120
71005895|NCT00853112|141520370|SUPERIORITY_OR_OTHER||Predicted Mean Difference|-170.6|STANDARD_DEVIATION|107.84||0.25|TWO_SIDED|95.0|-409.2|-7.1|||Bayesian 4-parameter Emax model.|||Change over 4 hours post-dose: The Bayesian 4-parameter Emax model was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of \>=240 dyne.s.m2/cm5 from placebo. The predicted means and SD were the posterior means and SD from the Bayesian analysis.||-7.1|-409.2|0.250
71005896|NCT00853112|141520370|SUPERIORITY_OR_OTHER||Predicted Mean Difference|-240.2|STANDARD_DEVIATION|109.28||0.485|TWO_SIDED|95.0|-444.8|-33.8|||Bayesian 4-parameter Emax model.|||The Bayesian 4-parameter Emax model was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of \>=240 dyne\*s\*m\^2/cm\^5 from placebo. The predicted means and SD were the posterior means and SD from the Bayesian analysis.||-33.8|-444.8|0.485
71005897|NCT00853112|141520370|SUPERIORITY_OR_OTHER||Predicted Mean Difference|-327.9|STANDARD_DEVIATION|92.41||0.81|TWO_SIDED|95.0|-492.9|-148.0|||Bayesian 4-parameter Emax model.|||Change over 4 hours post-dose: The Bayesian 4-parameter Emax model was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of \>=240 dyne\*s\*m\^2/cm\^5 from placebo. The predicted means and SD were the posterior means and SD from the Bayesian analysis.||-148.0|-492.9|0.810
71005898|NCT00853112|141520370|SUPERIORITY_OR_OTHER||Predicted Mean Difference|-379.4|STANDARD_DEVIATION|73.61||0.974|TWO_SIDED|95.0|-520.6|-238.8|||Bayesian 4-parameter Emax model|||Change over 4 hours post-dose: The Bayesian 4-parameter Emax model was used for analysis. Posterior distribution was calculated and was used to calculate a probability (presented as p value) that the dose gives a difference of \>=240 dyne\*s\*m\^2/cm\^5 from placebo. The predicted means and SD were the posterior means and SD from the Bayesian analysis.||-238.8|-520.6|0.974
71005899|NCT00853112|141520371|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-195.3|STANDARD_ERROR_OF_MEAN|207.38||0.354|TWO_SIDED|95.0|-618.8|228.3|||ANCOVA|||GR over 4 hours, PVRI: The analysis was performed using Analysis of Covariance (ANCOVA) with baseline fitted as a covariate.||228.3|-618.8|0.354
71005900|NCT00853112|141520371|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-34.1|STANDARD_ERROR_OF_MEAN|190.99||0.86|TWO_SIDED|95.0|-424.1|356.0|||ANCOVA|||GR over 4 hours, PVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||356.0|-424.1|0.860
71005901|NCT00853112|141520371|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-435.7|STANDARD_ERROR_OF_MEAN|195.94||0.034|TWO_SIDED|95.0|-835.9|-35.6|||ANCOVA|||GR over 4 hours, PVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||-35.6|-835.9|0.034
71005902|NCT00853112|141520371|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-334.7|STANDARD_ERROR_OF_MEAN|201.74||0.107|TWO_SIDED|95.0|-746.7|77.3|||ANCOVA|||GR over 4 hours, PVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||77.3|-746.7|0.107
71005903|NCT00853112|141520371|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-278.0|STANDARD_ERROR_OF_MEAN|200.89||0.177|TWO_SIDED|95.0|-688.3|132.2|||ANCOVA|||GR over 4 hours, PVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||132.2|-688.3|0.177
71101799|NCT05524948|141711260|OTHER||Adjusted Mean Difference|-32.68|STANDARD_ERROR_OF_MEAN|26.036||0.2124|TWO_SIDED|95.0|-84.36|18.99|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Dimethyl Sulfide|||18.99|-84.36|0.2124
71005904|NCT00853112|141520371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.1|STANDARD_ERROR_OF_MEAN|315.91||0.873|TWO_SIDED|95.0|-594.1|696.3|||ANCOVA|||GR over 4 hours, SVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||696.3|-594.1|0.873
71005905|NCT00853112|141520371|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|75.2|STANDARD_ERROR_OF_MEAN|303.08||0.806|TWO_SIDED|95.0|-543.8|694.1|||ANCOVA|||GR over 4 hours, SVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||694.1|-543.8|0.806
71005906|NCT00853112|141520371|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-262.8|STANDARD_ERROR_OF_MEAN|301.1||0.39|TWO_SIDED|95.0|-877.8|352.1|||ANCOVA|||GR over 4 hours, SVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||352.1|-877.8|0.390
71005907|NCT00853112|141520371|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-329.4|STANDARD_ERROR_OF_MEAN|302.97||0.286|TWO_SIDED|95.0|-948.1|289.4|||ANCOVA|||GR over 4 hours, SVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||289.4|-948.1|0.286
71005908|NCT00853112|141520371|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-62.7|STANDARD_ERROR_OF_MEAN|314.15||0.843|TWO_SIDED|95.0|-704.3|578.9|||ANCOVA|||GR over 4 hours, SVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||578.9|-704.3|0.843
71005909|NCT00853112|141520372|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|322.8||0.999|TWO_SIDED|95.0|-659.7|658.8|||ANCOVA|||The analysis was performed using ANCOVA with baseline fitted as a covariate.||658.8|-659.7|0.999
71005910|NCT00853112|141520372|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|72.2|STANDARD_ERROR_OF_MEAN|309.69||0.817|TWO_SIDED|95.0|-560.2|704.7|||ANCOVA|||The analysis was performed using ANCOVA with baseline fitted as a covariate.||704.7|-560.2|0.817
71005911|NCT00853112|141520372|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-82.6|STANDARD_ERROR_OF_MEAN|307.67||0.79|TWO_SIDED|95.0|-711.0|545.7|||ANCOVA|||The analysis was performed using ANCOVA with baseline fitted as a covariate.||545.7|-711.0|0.790
71005912|NCT00853112|141520372|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-325.6|STANDARD_ERROR_OF_MEAN|309.58||0.301|TWO_SIDED|95.0|-957.8|306.7|||ANCOVA|||The analysis was performed using ANCOVA with baseline fitted as a covariate.||306.7|-957.8|0.301
71005913|NCT00853112|141520372|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.2|STANDARD_ERROR_OF_MEAN|321.0||0.85|TWO_SIDED|95.0|-716.8|594.4|||ANCOVA|||The analysis was performed using ANCOVA with baseline fitted as a covariate.||594.4|-716.8|0.850
71005914|NCT00853112|141520373|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-269.32|STANDARD_ERROR_OF_MEAN|252.93||0.295|TWO_SIDED|95.0|-785.39|246.76|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||246.76|-785.39|0.295
71005915|NCT00853112|141520373|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-97.65|STANDARD_ERROR_OF_MEAN|234.55||0.68|TWO_SIDED|95.0|-577.02|381.72|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||381.72|-577.02|0.680
71005916|NCT00853112|141520373|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-376.61|STANDARD_ERROR_OF_MEAN|241.06||0.129|TWO_SIDED|95.0|-869.53|116.31|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||116.31|-869.53|0.129
71005917|NCT00853112|141520373|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-342.29|STANDARD_ERROR_OF_MEAN|247.07||0.176|TWO_SIDED|95.0|-846.9|162.32|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||162.32|-846.90|0.176
71005918|NCT00853112|141520373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-316.86|STANDARD_ERROR_OF_MEAN|261.58||0.235|TWO_SIDED|95.0|-850.9|217.17|||Longitudinal analysis|||Hour 1: Longitudinal analysis was used to analyze p-value and included baseline as a covariate.||217.17|-850.90|0.235
71005919|NCT00853112|141520373|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-198.06|STANDARD_ERROR_OF_MEAN|247.62||0.43|TWO_SIDED|95.0|-705.04|308.91|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||308.91|-705.04|0.430
71005920|NCT00853112|141520373|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|37.9|STANDARD_ERROR_OF_MEAN|229.23||0.87|TWO_SIDED|95.0|-432.23|508.04|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||508.04|-432.23|0.870
71005921|NCT00853112|141520373|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-114.06|STANDARD_ERROR_OF_MEAN|244.95||0.645|TWO_SIDED|95.0|-614.57|386.45|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||386.45|-614.57|0.645
71005922|NCT00853112|141520373|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-299.6|STANDARD_ERROR_OF_MEAN|241.63||0.225|TWO_SIDED|95.0|-794.81|195.61|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||195.61|-794.81|0.225
71101800|NCT05524948|141711261|OTHER||Adjusted Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.164|<|0.0001|TWO_SIDED|95.0|-1.52|-0.87|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and Baseline overall breath organoleptic score as a covariate.|Adjusted mean difference was calculated as experimental dentifrice minus reference dentifrice.|||-0.87|-1.52|<0.0001
70925342|NCT03210272|141343883|OTHER||Ratio T/R (%)|240.12|||||TWO_SIDED|90.0|196.25|293.81|||||intra-individual gCV (%) = 27.8|The statistical model to assess relative bioavailability in the FE part was an analysis of variance (ANOVA) on the ln-transformed parameters AUC and Cmax including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'||293.81|196.25|
71005923|NCT00853112|141520373|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-332.25|STANDARD_ERROR_OF_MEAN|255.93||0.205|TWO_SIDED|95.0|-856.55|192.05|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||192.05|-856.55|0.205
71005924|NCT00853112|141520373|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-86.72|STANDARD_ERROR_OF_MEAN|263.63||0.745|TWO_SIDED|95.0|-625.87|452.42|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||452.42|-625.87|0.745
71005925|NCT00853112|141520373|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|18.0|STANDARD_ERROR_OF_MEAN|245.25||0.942|TWO_SIDED|95.0|-484.46|520.47|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||520.47|-484.46|0.942
71005926|NCT00853112|141520373|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-265.94|STANDARD_ERROR_OF_MEAN|259.53||0.314|TWO_SIDED|95.0|-796.15|264.28|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||264.28|-796.15|0.314
71005927|NCT00853112|141520373|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-275.35|STANDARD_ERROR_OF_MEAN|258.01||0.295|TWO_SIDED|95.0|-803.57|252.88|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||252.88|-803.57|0.295
71005928|NCT00853112|141520373|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-326.55|STANDARD_ERROR_OF_MEAN|272.96||0.241|TWO_SIDED|95.0|-885.12|232.02|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||232.02|-885.12|0.241
71005929|NCT00853112|141520373|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-145.71|STANDARD_ERROR_OF_MEAN|218.5||0.51|TWO_SIDED|95.0|-592.24|300.83|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||300.83|-592.24|0.510
71005930|NCT00853112|141520373|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|77.96|STANDARD_ERROR_OF_MEAN|199.85||0.699|TWO_SIDED|95.0|-330.7|486.63|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||486.63|-330.70|0.699
71005931|NCT00853112|141520373|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-341.91|STANDARD_ERROR_OF_MEAN|204.65||0.106|TWO_SIDED|95.0|-760.45|76.64|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||76.64|-760.45|0.106
71101801|NCT05155085|141711262|SUPERIORITY||Risk Difference (RD)|5.1||||0.4662|TWO_SIDED|95.0|-9.8|19.8|||Cochran-Mantel-Haenszel|||||19.8|-9.8|0.4662
71005932|NCT00853112|141520373|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-289.41|STANDARD_ERROR_OF_MEAN|211.69||0.182|TWO_SIDED|95.0|-722.17|143.35|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||143.35|-722.17|0.182
71005933|NCT00853112|141520373|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-256.6|STANDARD_ERROR_OF_MEAN|224.88||0.263|TWO_SIDED|95.0|-716.26|203.06|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||203.06|-716.26|0.263
71005934|NCT00853112|141520374|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-328.1|STANDARD_ERROR_OF_MEAN|385.78||0.401|TWO_SIDED|95.0|-1114.11|457.92|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||457.92|-1114.11|0.401
71005935|NCT00853112|141520374|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-164.96|STANDARD_ERROR_OF_MEAN|370.54||0.659|TWO_SIDED|95.0|-920.05|590.12|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||590.12|-920.05|0.659
71005936|NCT00853112|141520374|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-287.08|STANDARD_ERROR_OF_MEAN|372.6||0.447|TWO_SIDED|95.0|-1047.59|473.42|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||473.42|-1047.59|0.447
71005937|NCT00853112|141520374|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-457.16|STANDARD_ERROR_OF_MEAN|374.26||0.231|TWO_SIDED|95.0|-1220.86|306.53|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||306.53|-1220.86|0.231
71005938|NCT00853112|141520374|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-75.24|STANDARD_ERROR_OF_MEAN|384.2||0.846|TWO_SIDED|95.0|-858.19|707.71|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||707.71|-858.19|0.846
71005939|NCT00853112|141520374|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-115.64|STANDARD_ERROR_OF_MEAN|357.2||0.748|TWO_SIDED|95.0|-844.24|612.96|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||612.96|-844.24|0.748
71005940|NCT00853112|141520374|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.87|STANDARD_ERROR_OF_MEAN|342.91||0.993|TWO_SIDED|95.0|-702.41|696.67|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||696.67|-702.41|0.993
71005941|NCT00853112|141520374|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|174.2|STANDARD_ERROR_OF_MEAN|342.93||0.615|TWO_SIDED|95.0|-526.41|874.81|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||874.81|-526.41|0.615
71005942|NCT00853112|141520374|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-494.91|STANDARD_ERROR_OF_MEAN|344.72||0.161|TWO_SIDED|95.0|-1199.04|209.21|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||209.21|-1199.04|0.161
71005943|NCT00853112|141520374|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-134.48|STANDARD_ERROR_OF_MEAN|355.5||0.708|TWO_SIDED|95.0|-859.74|590.77|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||590.77|-859.74|0.708
71044922|NCT03575871|141599156|SUPERIORITY||Difference in Percentage|33.9|||<|0.0001|TWO_SIDED|95.0|23.3|44.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||44.4|23.3|<0.0001
71005944|NCT00853112|141520374|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|47.61|STANDARD_ERROR_OF_MEAN|365.43||0.897|TWO_SIDED|95.0|-697.56|792.79|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||792.79|-697.56|0.897
71005945|NCT00853112|141520374|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|98.42|STANDARD_ERROR_OF_MEAN|350.87||0.781|TWO_SIDED|95.0|-617.15|813.99|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||813.99|-617.15|0.781
71005946|NCT00853112|141520374|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-28.31|STANDARD_ERROR_OF_MEAN|355.47||0.937|TWO_SIDED|95.0|-753.46|696.83|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||696.83|-753.46|0.937
71005947|NCT00853112|141520374|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-369.57|STANDARD_ERROR_OF_MEAN|353.25||0.304|TWO_SIDED|95.0|-1090.86|351.72|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||351.72|-1090.86|0.304
71005948|NCT00853112|141520374|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-185.64|STANDARD_ERROR_OF_MEAN|363.77||0.613|TWO_SIDED|95.0|-927.54|556.27|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||556.27|-927.54|0.613
71005949|NCT00853112|141520374|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|265.51|STANDARD_ERROR_OF_MEAN|324.88||0.42|TWO_SIDED|95.0|-397.45|928.48|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||928.48|-397.45|0.420
71005950|NCT00853112|141520374|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|240.17|STANDARD_ERROR_OF_MEAN|311.63||0.447|TWO_SIDED|95.0|-395.81|876.14|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||876.14|-395.81|0.447
71005951|NCT00853112|141520374|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-176.74|STANDARD_ERROR_OF_MEAN|309.11||0.572|TWO_SIDED|95.0|-808.1|454.63|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||454.63|-808.10|0.572
71005952|NCT00853112|141520374|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.96|STANDARD_ERROR_OF_MEAN|311.11||0.929|TWO_SIDED|95.0|-663.31|607.38|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||607.38|-663.31|0.929
71005953|NCT00853112|141520374|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|29.58|STANDARD_ERROR_OF_MEAN|323.01||0.928|TWO_SIDED|95.0|-629.62|688.79|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||688.79|-629.62|0.928
71005954|NCT00853112|141520375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.29||0.412|TWO_SIDED|95.0|-0.35|0.83|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.83|-0.35|0.412
71101802|NCT05155085|141711263|SUPERIORITY||LSM Difference from Placebo|-9.7|STANDARD_ERROR_OF_MEAN|11.4||0.3968|TWO_SIDED|95.0|-32.2|12.9|||Mixed Models Analysis|||||12.9|-32.2|0.3968
71101803|NCT05155085|141711264|SUPERIORITY||Risk Difference (RD)|3.3||||0.7625|TWO_SIDED|95.0|-15.2|21.6|||Fisher Exact|||||21.6|-15.2|0.7625
71005955|NCT00853112|141520375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.28||0.999|TWO_SIDED|95.0|-0.58|0.58|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.58|-0.58|0.999
71005956|NCT00853112|141520375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.28||0.535|TWO_SIDED|95.0|-0.39|0.74|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.74|-0.39|0.535
71044923|NCT03575871|141599156|SUPERIORITY||Difference in Percentage|50.5|||<|0.0001|TWO_SIDED|95.0|40.0|60.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||60.9|40.0|<0.0001
71044924|NCT03575871|141599157|SUPERIORITY||Difference in Percentage|19.2||||0.0002|TWO_SIDED|95.0|11.0|27.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||27.4|11.0|0.0002
71044925|NCT03575871|141599157|SUPERIORITY||Difference in Percentage|31.2|||<|0.0001|TWO_SIDED|95.0|22.3|40.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||40.2|22.3|<0.0001
71044926|NCT03575871|141599157|SUPERIORITY||Difference in Percentage|27.5|||<|0.0001|TWO_SIDED|95.0|18.9|36.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||36.2|18.9|<0.0001
71044927|NCT03575871|141599157|SUPERIORITY||Difference in Percentage|46.4|||<|0.0001|TWO_SIDED|95.0|37.2|55.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||55.7|37.2|<0.0001
71044928|NCT03575871|141599157|SUPERIORITY||Difference in Percentage|27.4|||<|0.0001|TWO_SIDED|95.0|16.8|38.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.0|16.8|<0.0001
71044929|NCT03575871|141599157|SUPERIORITY||Difference in Percentage|39.8|||<|0.0001|TWO_SIDED|95.0|28.9|50.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||50.6|28.9|<0.0001
71044930|NCT03575871|141599157|SUPERIORITY||Difference in Percentage|29.3|||<|0.0001|TWO_SIDED|95.0|18.9|39.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||39.6|18.9|<0.0001
71044931|NCT03575871|141599157|SUPERIORITY||Difference in Percentage|38.6|||<|0.0001|TWO_SIDED|95.0|28.1|49.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||49.1|28.1|<0.0001
71044932|NCT03575871|141599158|SUPERIORITY||Difference in LS mean|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.3|-1.1|||Mixed Models Analysis|||Mixed Model Repeated Measure (MMRM) contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.1|-2.3|<0.0001
71044933|NCT03575871|141599158|SUPERIORITY||Difference in LS mean|-2.2|||<|0.0001|TWO_SIDED|95.0|-2.8|-1.6|||Mixed Models Analysis|||Mixed Model Repeated Measure (MMRM) contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.6|-2.8|<0.0001
71005957|NCT00853112|141520375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.28||0.128|TWO_SIDED|95.0|-0.13|1.01|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||1.01|-0.13|0.128
71005958|NCT00853112|141520375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.29||0.823|TWO_SIDED|95.0|-0.67|0.53|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.53|-0.67|0.823
71005959|NCT00853112|141520375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.34||0.396|TWO_SIDED|95.0|-0.4|0.99|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.99|-0.40|0.396
71005960|NCT00853112|141520375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.33||0.899|TWO_SIDED|95.0|-0.63|0.72|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.72|-0.63|0.899
71005961|NCT00853112|141520375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.33||0.928|TWO_SIDED|95.0|-0.7|0.64|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.64|-0.70|0.928
71005962|NCT00853112|141520375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.33||0.203|TWO_SIDED|95.0|-0.25|1.11|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||1.11|-0.25|0.203
71005963|NCT00853112|141520375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.34||0.772|TWO_SIDED|95.0|-0.6|0.8|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.80|-0.60|0.772
71005964|NCT00853112|141520375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.29||0.771|TWO_SIDED|95.0|-0.52|0.69|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.69|-0.52|0.771
71005965|NCT00853112|141520375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.29||0.572|TWO_SIDED|95.0|-0.75|0.42|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.42|-0.75|0.572
71005966|NCT00853112|141520375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.29||0.966|TWO_SIDED|95.0|-0.58|0.6|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.60|-0.58|0.966
71005967|NCT00853112|141520375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.28||0.157|TWO_SIDED|95.0|-0.17|1.0|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||1.00|-0.17|0.157
71044934|NCT03575871|141599160|SUPERIORITY||Difference in Percentage|8.8||||0.015|TWO_SIDED|95.0|2.8|14.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||14.9|2.8|0.0150
71044935|NCT03575871|141599160|SUPERIORITY||Difference in Percentage|22.7|||<|0.0001|TWO_SIDED|95.0|15.0|30.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||30.3|15.0|<0.0001
71005968|NCT00853112|141520375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.3||0.546|TWO_SIDED|95.0|-0.43|0.79|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.79|-0.43|0.546
71005969|NCT00853112|141520375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.28||0.818|TWO_SIDED|95.0|-0.51|0.64|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.64|-0.51|0.818
71005970|NCT00853112|141520375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.28||0.603|TWO_SIDED|95.0|-0.71|0.42|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.42|-0.71|0.603
71005971|NCT00853112|141520375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.27||0.495|TWO_SIDED|95.0|-0.37|0.74|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.74|-0.37|0.495
71005972|NCT00853112|141520375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.27||0.375|TWO_SIDED|95.0|-0.31|0.8|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.80|-0.31|0.375
71005973|NCT00853112|141520375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.29||0.392|TWO_SIDED|95.0|-0.34|0.84|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.84|-0.34|0.392
71005974|NCT00853112|141520376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|3.75||0.21|TWO_SIDED|95.0|-12.47|2.86|||Longitudinal analysis|||mPAP at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||2.86|-12.47|0.210
71044936|NCT03575871|141599160|SUPERIORITY||Difference in Percentage|20.0||||0.0004|TWO_SIDED|95.0|10.9|29.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||29.0|10.9|0.0004
71005975|NCT00853112|141520376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.47|STANDARD_ERROR_OF_MEAN|3.61||0.225|TWO_SIDED|95.0|-11.84|2.9|||Longitudinal analysis|||mPAP at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||2.90|-11.84|0.225
71005976|NCT00853112|141520376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.67|STANDARD_ERROR_OF_MEAN|3.73||0.332|TWO_SIDED|95.0|-11.28|3.93|||Longitudinal analysis|||mPAP at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||3.93|-11.28|0.332
71005977|NCT00853112|141520376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|3.76||0.714|TWO_SIDED|95.0|-9.06|6.28|||Longitudinal analysis|||mPAP at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||6.28|-9.06|0.714
71005978|NCT00853112|141520376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.01|STANDARD_ERROR_OF_MEAN|3.73||0.04|TWO_SIDED|95.0|-15.63|-0.39|||Longitudinal analysis|||mPAP at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||-0.39|-15.63|0.040
71005979|NCT00853112|141520376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.14|STANDARD_ERROR_OF_MEAN|3.37||0.079|TWO_SIDED|95.0|-13.02|0.75|||Longitudinal analysis|||mPAP at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.75|-13.02|0.079
71005980|NCT00853112|141520376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.85|STANDARD_ERROR_OF_MEAN|3.24||0.573|TWO_SIDED|95.0|-8.46|4.77|||Longitudinal analysis|||mPAP at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||4.77|-8.46|0.573
71005981|NCT00853112|141520376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.67|STANDARD_ERROR_OF_MEAN|3.34||0.28|TWO_SIDED|95.0|-10.5|3.15|||Longitudinal analysis|||mPAP at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||3.15|-10.50|0.280
71005982|NCT00853112|141520376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|3.38||0.684|TWO_SIDED|95.0|-8.28|5.51|||Longitudinal analysis|||mPAP at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||5.51|-8.28|0.684
71005983|NCT00853112|141520376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.17|STANDARD_ERROR_OF_MEAN|3.35||0.021|TWO_SIDED|95.0|-15.01|-1.34|||Longitudinal analysis|||mPAP at Hour 2: Longitudinal analysis was used to analyze p-value and included baseline as a covariate.||-1.34|-15.01|0.021
71005984|NCT00853112|141520376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|3.7||0.727|TWO_SIDED|95.0|-8.86|6.25|||Longitudinal analysis|||mPAP at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||6.25|-8.86|0.727
71005985|NCT00853112|141520376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.85|STANDARD_ERROR_OF_MEAN|3.56||0.183|TWO_SIDED|95.0|-12.12|2.42|||Longitudinal analysis|||mPAP at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||2.42|-12.12|0.183
71005986|NCT00853112|141520376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.01|STANDARD_ERROR_OF_MEAN|3.67||0.112|TWO_SIDED|95.0|-13.51|1.49|||Longitudinal analysis|||mPAP at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||1.49|-13.51|0.112
71005987|NCT00853112|141520376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|3.71||0.928|TWO_SIDED|95.0|-7.91|7.23|||Longitudinal analysis|||mPAP at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||7.23|-7.91|0.928
71044937|NCT03575871|141599160|SUPERIORITY||Difference in Percentage|44.3|||<|0.0001|TWO_SIDED|95.0|34.8|53.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||53.8|34.8|<0.0001
71005988|NCT00853112|141520376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-9.01|STANDARD_ERROR_OF_MEAN|3.68||0.02|TWO_SIDED|95.0|-16.52|-1.5|||Longitudinal analysis|||mPAP at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||-1.50|-16.52|0.020
71005989|NCT00853112|141520376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|3.79||0.136|TWO_SIDED|95.0|-13.55|1.94|||Longitudinal analysis|||mPAP at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||1.94|-13.55|0.136
71005990|NCT00853112|141520376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.82|STANDARD_ERROR_OF_MEAN|3.65||0.303|TWO_SIDED|95.0|-11.27|3.63|||Longitudinal analysis|||mPAP at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||3.63|-11.27|0.303
71005991|NCT00853112|141520376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.17|STANDARD_ERROR_OF_MEAN|3.77||0.18|TWO_SIDED|95.0|-12.87|2.52|||Longitudinal analysis|||mPAP at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||2.52|-12.87|0.180
71005992|NCT00853112|141520376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.56|STANDARD_ERROR_OF_MEAN|3.8||0.506|TWO_SIDED|95.0|-10.31|5.2|||Longitudinal analysis|||mPAP at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||5.20|-10.31|0.506
71005993|NCT00853112|141520376|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.84|STANDARD_ERROR_OF_MEAN|3.77||0.026|TWO_SIDED|95.0|-16.54|-1.14|||Longitudinal analysis|||mPAP at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||-1.14|-16.54|0.026
71005994|NCT01553591|141520384|SUPERIORITY|||||||0.014||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||0.014
71005995|NCT01553591|141520384|SUPERIORITY|||||||0.004||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||0.004
71005996|NCT01553591|141520385|SUPERIORITY|||||||0.112||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||0.112
71005997|NCT01553591|141520385|SUPERIORITY||||||<|0.001||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||<0.001
71005998|NCT00397631|141520412|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.89|STANDARD_ERROR_OF_MEAN|0.12|<|0.001||95.0|-1.13|-0.65|||ANCOVA|Model terms: treatment, baseline HbA1c||||-0.65|-1.13|<0.001
71005999|NCT00397631|141520413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.8|STANDARD_ERROR_OF_MEAN|3.87|<|0.001||95.0|-30.4|-15.2|||ANCOVA|Model terms: treatment, baseline FPG||||-15.2|-30.4|<0.001
71101804|NCT00855166|141711291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.08|STANDARD_ERROR_OF_MEAN|0.3885|<|0.0001|TWO_SIDED|95.0|-2.84|-1.31||Significant at alpha=0.05 (2-sided)|ANCOVA|with treatment group and stratum (gender) as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.31|-2.84|<0.0001
71006000|NCT00397631|141520414|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-44.7|STANDARD_ERROR_OF_MEAN|6.37|<|0.001||95.0|-57.2|32.2|||ANCOVA|Model terms: treatment, baseline 2-hour PPG||||32.2|-57.2|<0.001
71006001|NCT02202161|141520415|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-1.17|||||TWO_SIDED|95.0|-25.61|23.27|||||Comparison for fasting, Day 7|An estimation approach was used.||23.27|-25.61|
71006002|NCT02202161|141520415|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|13.22|||||TWO_SIDED|95.0|-9.84|36.27|||||Comparison for fasting, Day 7|An estimation approach was used.||36.27|-9.84|
71101805|NCT00855166|141711292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.52|STANDARD_ERROR_OF_MEAN|0.6162||0.0143|TWO_SIDED|95.0|-2.74|-0.31||Significant at alpha=0.05 (2-sided). Results of key secondary endpoints are interpreted using Hochberg's method|ANCOVA|with treatment group and stratum (gender) as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.31|-2.74|0.0143
71101806|NCT00855166|141711293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.48|STANDARD_ERROR_OF_MEAN|0.3731||0.0001|TWO_SIDED|95.0|-2.22|-0.74||Significant at alpha=0.05 (2-sided). Results of key secondary endpoints are interpreted using Hochberg's method|ANCOVA|with treatment group and stratum (gender) as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.74|-2.22|0.0001
71006003|NCT02202161|141520415|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-21.77|||||TWO_SIDED|95.0|-41.43|-2.1|||||Comparison for fasting, Day 7|An estimation approach was used.||-2.10|-41.43|
71006004|NCT02202161|141520415|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-23.1|||||TWO_SIDED|95.0|-42.63|-3.57|||||Comparison for fasting, Day 7|An estimation approach was used.||-3.57|-42.63|
71006005|NCT02202161|141520415|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-11.79|||||TWO_SIDED|95.0|-30.85|7.28|||||Comparison for fasting, Day 7|An estimation approach was used.||7.28|-30.85|
71006006|NCT02202161|141520415|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-10.04|||||TWO_SIDED|95.0|-27.66|7.57|||||Comparison for fasting, Day 7|An estimation approach was used.||7.57|-27.66|
71006007|NCT02202161|141520415|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-15.14|||||TWO_SIDED|95.0|-37.72|7.43|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.||7.43|-37.72|
71006008|NCT02202161|141520415|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-2.1|||||TWO_SIDED|95.0|-23.66|19.45|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.||19.45|-23.66|
71101807|NCT00855166|141711294|SUPERIORITY_OR_OTHER||Risk Difference (RD)|26.3|STANDARD_ERROR_OF_MEAN|5.309|<|0.0001|TWO_SIDED|95.0|15.9|36.7||Significant at alpha=0.05 (2-sided). Results of key secondary endpoints are interpreted using Hochberg's method|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value and stratum (gender).||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||36.7|15.9|<0.0001
71006009|NCT02202161|141520415|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-20.66|||||TWO_SIDED|95.0|-38.75|-2.57|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.||-2.57|-38.75|
71006010|NCT02202161|141520415|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-21.7|||||TWO_SIDED|95.0|-39.7|-3.71|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.||-3.71|-39.70|
71006011|NCT02202161|141520415|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-10.62|||||TWO_SIDED|95.0|-28.62|7.38|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.||7.38|-28.62|
71006012|NCT02202161|141520415|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-26.03|||||TWO_SIDED|95.0|-41.94|-10.12|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.||-10.12|-41.94|
71006013|NCT02202161|141520415|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-12.1|||||TWO_SIDED|95.0|-33.56|9.36|||||Comparison for fasting, Day 14|An estimation approach was used.||9.36|-33.56|
71006014|NCT02202161|141520415|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|4.33|||||TWO_SIDED|95.0|-15.91|24.57|||||Comparison for fasting, Day 14|An estimation approach was used.||24.57|-15.91|
71006015|NCT02202161|141520415|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-25.29|||||TWO_SIDED|95.0|-42.56|-8.02|||||Comparison for fasting, Day 14|An estimation approach was used.||-8.02|-42.56|
71006016|NCT02202161|141520415|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-19.97|||||TWO_SIDED|95.0|-37.12|-2.82|||||Comparison for fasting, Day 14|An estimation approach was used.||-2.82|-37.12|
71006017|NCT02202161|141520415|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-21.82|||||TWO_SIDED|95.0|-38.56|-5.08|||||Comparison for fasting, Day 14|An estimation approach was used.||-5.08|-38.56|
71006018|NCT02202161|141520415|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-18.01|||||TWO_SIDED|95.0|-33.48|-2.55|||||Comparison for fasting, Day 14|An estimation approach was used.||-2.55|-33.48|
71006019|NCT02202161|141520415|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-11.2|||||TWO_SIDED|95.0|-33.21|10.81|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.||10.81|-33.21|
71006020|NCT02202161|141520415|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|4.8|||||TWO_SIDED|95.0|-16.22|25.81|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.||25.81|-16.22|
71006021|NCT02202161|141520415|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-15.23|||||TWO_SIDED|95.0|-32.86|2.41|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.||2.41|-32.86|
71006022|NCT02202161|141520415|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-17.01|||||TWO_SIDED|95.0|-34.56|0.53|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.||0.53|-34.56|
71006023|NCT02202161|141520415|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-23.94|||||TWO_SIDED|95.0|-41.49|-6.39|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.||-6.39|-41.49|
71006024|NCT02202161|141520415|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-19.45|||||TWO_SIDED|95.0|-34.96|-3.93|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.||-3.93|-34.96|
71006025|NCT02202161|141520430|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.17|||||TWO_SIDED|90.0|0.92|1.49|||||Mean and confidence interval (CI) for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.49|0.92|
71006026|NCT02202161|141520430|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.11|||||TWO_SIDED|90.0|0.89|1.38|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.38|0.89|
71006027|NCT02202161|141520430|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.05|||||TWO_SIDED|90.0|0.87|1.27|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.27|0.87|
71006028|NCT02202161|141520430|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.25|||||TWO_SIDED|90.0|1.03|1.52|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.52|1.03|
71006029|NCT02202161|141520430|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.25|||||TWO_SIDED|90.0|1.04|1.5|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.50|1.04|
71006030|NCT02202161|141520430|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.11|||||TWO_SIDED|90.0|0.94|1.31|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.31|0.94|
71006031|NCT02202161|141520432|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|0.88|||||TWO_SIDED|90.0|0.68|1.13|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.13|0.68|
71006032|NCT02202161|141520432|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|1.04|||||TWO_SIDED|90.0|0.82|1.31|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.31|0.82|
71006033|NCT02202161|141520432|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|1.04|||||TWO_SIDED|90.0|0.85|1.26|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.26|0.85|
71006034|NCT02202161|141520432|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|1.19|||||TWO_SIDED|90.0|0.97|1.45|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.45|0.97|
71006035|NCT02202161|141520432|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|1.23|||||TWO_SIDED|90.0|1.01|1.49|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.49|1.01|
71006036|NCT02202161|141520432|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|1.24|||||TWO_SIDED|90.0|1.04|1.48|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.48|1.04|
71006037|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.03|||||TWO_SIDED|95.0|0.91|1.17|||||Comparison for Day 7, cholesterol|An estimation approach was used.||1.17|0.91|
71006038|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.88|||||TWO_SIDED|95.0|0.78|0.98|||||Comparison for Day 7, cholesterol|An estimation approach was used.||0.98|0.78|
71006039|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.86|||||TWO_SIDED|95.0|0.78|0.95|||||Comparison for Day 7, cholesterol|An estimation approach was used.||0.95|0.78|
71006040|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.75|||||TWO_SIDED|95.0|0.68|0.83|||||Comparison for Day 7, cholesterol|An estimation approach was used.||0.83|0.68|
71006041|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.83|||||TWO_SIDED|95.0|0.76|0.92|||||Comparison for Day 7, cholesterol|An estimation approach was used.||0.92|0.76|
71006042|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.01|||||TWO_SIDED|95.0|0.92|1.1|||||Comparison for Day 7, cholesterol|An estimation approach was used.||1.10|0.92|
71006043|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.07|||||TWO_SIDED|95.0|0.95|1.19|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.||1.19|0.95|
71006044|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.04|||||TWO_SIDED|95.0|0.94|1.16|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.||1.16|0.94|
71006045|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.96|||||TWO_SIDED|95.0|0.88|1.05|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.||1.05|0.88|
71006046|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.98|||||TWO_SIDED|95.0|0.89|1.07|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.||1.07|0.89|
71006047|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.07|||||TWO_SIDED|95.0|0.98|1.17|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.||1.17|0.98|
71006048|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.97|||||TWO_SIDED|95.0|0.9|1.05|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.||1.05|0.90|
71006049|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.95|||||TWO_SIDED|95.0|0.8|1.13|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.||1.13|0.80|
71006050|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.76|||||TWO_SIDED|95.0|0.65|0.9|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.||0.90|0.65|
71006051|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.74|||||TWO_SIDED|95.0|0.64|0.85|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.||0.85|0.64|
71006052|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.59|||||TWO_SIDED|95.0|0.51|0.69|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.||0.69|0.51|
71006053|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.71|||||TWO_SIDED|95.0|0.62|0.81|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.||0.81|0.62|
71006054|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|0.89|1.14|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.||1.14|0.89|
71006055|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.03|||||TWO_SIDED|95.0|0.88|1.21|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.||1.21|0.88|
71006056|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.82|||||TWO_SIDED|95.0|0.71|0.95|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.||0.95|0.71|
71006057|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.84|||||TWO_SIDED|95.0|0.74|0.95|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.||0.95|0.74|
71006058|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.67|||||TWO_SIDED|95.0|0.59|0.76|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.||0.76|0.59|
71006059|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.77|||||TWO_SIDED|95.0|0.68|0.87|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.||0.87|0.68|
71006060|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.02|||||TWO_SIDED|95.0|0.92|1.14|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.||1.14|0.92|
71006061|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.27|||||TWO_SIDED|95.0|0.97|1.66|||||Comparison for Day 7, triglycerides|An estimation approach was used.||1.66|0.97|
71006062|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.16|||||TWO_SIDED|95.0|0.9|1.5|||||Comparison for Day 7, triglycerides|An estimation approach was used.||1.50|0.90|
71006063|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.3|||||TWO_SIDED|95.0|1.06|1.61|||||Comparison for Day 7, triglycerides|An estimation approach was used.||1.61|1.06|
71044938|NCT03575871|141599160|SUPERIORITY||Difference in Percentage|30.4|||<|0.0001|TWO_SIDED|95.0|19.7|41.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||41.2|19.7|<0.0001
71006064|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.19|||||TWO_SIDED|95.0|0.96|1.48|||||Comparison for Day 7, triglycerides|An estimation approach was used.||1.48|0.96|
71006065|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.15|||||TWO_SIDED|95.0|0.93|1.42|||||Comparison for Day 7, triglycerides|An estimation approach was used.||1.42|0.93|
71006066|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.95|||||TWO_SIDED|95.0|0.79|1.16|||||Comparison for Day 7, triglycerides|An estimation approach was used.||1.16|0.79|
71006067|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|0.86|1.17|||||Comparison for Day 14, cholesterol|An estimation approach was used.||1.17|0.86|
71006068|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.83|||||TWO_SIDED|95.0|0.73|0.96|||||Comparison for Day 14, cholesterol|An estimation approach was used.||0.96|0.73|
71006069|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.82|||||TWO_SIDED|95.0|0.73|0.91|||||Comparison for Day 14, cholesterol|An estimation approach was used.||0.91|0.73|
71006070|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.74|||||TWO_SIDED|95.0|0.66|0.82|||||Comparison for Day 14, cholesterol|An estimation approach was used.||0.82|0.66|
71006071|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.77|||||TWO_SIDED|95.0|0.69|0.86|||||Comparison for Day 14, cholesterol|An estimation approach was used.||0.86|0.69|
71006072|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.93|||||TWO_SIDED|95.0|0.84|1.03|||||Comparison for Day 14, cholesterol|An estimation approach was used.||1.03|0.84|
71101808|NCT00855166|141711295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.5652||0.7013|TWO_SIDED|95.0|-0.89|1.34||Exploratory. Model including fixed categorical effects of treatment, week, treatment-by-week interaction, gender and rescue medication as well as continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.|Mixed Models Analysis|Percent change in BMD from baseline to week 102 evaluated via longitudinal repeated measures analysis using direct likelihood.|Natural logarithms of baseline and week 102 values were used.|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||1.34|-0.89|0.7013
71101809|NCT00855166|141711296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|0.6473||0.1521|TWO_SIDED|95.0|-2.21|0.35||Exploratory. Model including fixed categorical effects of treatment, week, treatment-by-week interaction, gender and rescue medication as well as continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.|Mixed Models Analysis|Percent change in BMD from baseline to week 102 evaluated via longitudinal repeated measures analysis using direct likelihood.|Natural logarithms of baseline and week 102 values were used.|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||0.35|-2.21|0.1521
71101810|NCT00855166|141711297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.4428||0.3105|TWO_SIDED|95.0|-1.32|0.43||Exploratory. Model including fixed categorical effects of treatment, week, treatment-by-week interaction, gender and rescue medication as well as continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.|Mixed Models Analysis|Percent change in BMD from baseline to week 102 evaluated via longitudinal repeated measures analysis using direct likelihood.|Natural logarithms of baseline and week 102 values were used.|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||0.43|-1.32|0.3105
71101811|NCT02702999|141711298|SUPERIORITY||Risk Ratio (RR)|3.9|||||TWO_SIDED|95.0|0.9|18.0|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).|||18.0|0.9|
71101812|NCT02702999|141711299|SUPERIORITY||Risk Ratio (RR)|3.9|||||TWO_SIDED|95.0|0.9|18.0|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).|||18.0|0.9|
71101813|NCT02702999|141711300|SUPERIORITY||Risk Ratio (RR)|1.9|||||TWO_SIDED|95.0|0.4|10.5|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).|||10.5|0.4|
71101814|NCT02702999|141711301|SUPERIORITY||Risk Ratio (RR)|5.4|||||TWO_SIDED|95.0|1.2|23.7|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).|||23.7|1.2|
71101815|NCT02702999|141711302|SUPERIORITY||Risk Ratio (RR)|0.2|||||TWO_SIDED|95.0|0.03|2.1|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).|||2.1|0.03|
71101816|NCT02702999|141711303|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.4|2.3|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).|||2.3|0.4|
71101817|NCT01272219|141711304|SUPERIORITY_OR_OTHER||Estimated mean difference|-5.39|||<|0.0001|TWO_SIDED|95.0|-5.82|-4.95|||ANCOVA||ANCOVA model with treatment, country, sex, pre-diabetes status at screening, baseline BMI stratum and an interaction between pre-diabetes status at screening and BMI stratum as fixed factors, and the baseline value as covariate.|Null-hypothesis: no treatment difference between treatment arms, i.e. liraglutide 3.0 mg and liraglutide placebo. Liraglutide 3.0 mg was considered superior to placebo in inducing and maintaining weight loss, if the estimated treatment effect (liraglutide 3.0 mg - liraglutide placebo) was statistically significantly smaller than zero.||-4.95|-5.82|<0.0001
71006073|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.09|||||TWO_SIDED|95.0|0.99|1.21|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.||1.21|0.99|
71044939|NCT03575871|141599160|SUPERIORITY||Difference in Percentage|47.4|||<|0.0001|TWO_SIDED|95.0|36.8|58.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||58.0|36.8|<0.0001
71044940|NCT03575871|141599161|SUPERIORITY||Difference in Percentage|5.1||||0.0459|TWO_SIDED|95.0|0.2|10.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||10.0|0.2|0.0459
71101818|NCT01272219|141711305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.8|||<|0.0001|TWO_SIDED|95.0|4.12|5.6|||Regression, Logistic||The model included treatment, country, sex, pre-diabetes status at screening, BMI stratum and an interaction between pre-diabetes status at screening and BMI stratum as fixed factors, and the baseline value as covariate.|Null-hypothesis: no treatment difference between treatment arms, i.e. liraglutide 3.0 mg and liraglutide placebo. Liraglutide 3.0 mg was considered superior to placebo in inducing and maintaining weight loss as assessed by the proportion of subjects losing ≥5% of their fasting baseline weight, if the estimated odds ratio (liraglutide 3.0 mg/liraglutide placebo) was statistically significantly greater than one.||5.60|4.12|<0.0001
71006074|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.02|||||TWO_SIDED|95.0|0.93|1.11|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.||1.11|0.93|
71006075|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.97|||||TWO_SIDED|95.0|0.9|1.04|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.||1.04|0.90|
71006076|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.99|||||TWO_SIDED|95.0|0.92|1.06|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.||1.06|0.92|
71006077|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.01|||||TWO_SIDED|95.0|0.94|1.08|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.||1.08|0.94|
71006078|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.98|||||TWO_SIDED|95.0|0.92|1.04|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.||1.04|0.92|
71006079|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.85|||||TWO_SIDED|95.0|0.69|1.04|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.||1.04|0.69|
71006080|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|0.58|0.85|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.||0.85|0.58|
71044941|NCT03575871|141599161|SUPERIORITY||Difference in Percentage|14.2||||0.0005|TWO_SIDED|95.0|7.8|20.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||20.5|7.8|0.0005
71044942|NCT03575871|141599161|SUPERIORITY||Difference in Percentage|12.9||||0.0019|TWO_SIDED|95.0|6.3|19.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||19.4|6.3|0.0019
71006081|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.73|||||TWO_SIDED|95.0|0.62|0.86|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.||0.86|0.62|
71006082|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.6|||||TWO_SIDED|95.0|0.5|0.71|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.||0.71|0.50|
71006083|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.69|||||TWO_SIDED|95.0|0.59|0.8|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.||0.80|0.59|
71006084|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.94|||||TWO_SIDED|95.0|0.81|1.09|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.||1.09|0.81|
71006085|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.99|||||TWO_SIDED|95.0|0.8|1.22|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.||1.22|0.80|
71006086|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.77|||||TWO_SIDED|95.0|0.64|0.93|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.||0.93|0.64|
71006087|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.77|||||TWO_SIDED|95.0|0.67|0.9|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.||0.90|0.67|
71006088|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.65|||||TWO_SIDED|95.0|0.55|0.75|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.||0.75|0.55|
71006089|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|0.6|0.81|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.||0.81|0.60|
71006090|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.91|||||TWO_SIDED|95.0|0.8|1.04|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.||1.04|0.80|
71006091|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.42|||||TWO_SIDED|95.0|1.01|2.0|||||Comparison for Day 14, triglycerides|An estimation approach was used.||2.00|1.01|
71044943|NCT03575871|141599161|SUPERIORITY||Difference in Percentage|31.8|||<|0.0001|TWO_SIDED|95.0|23.6|39.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||39.9|23.6|<0.0001
71044944|NCT03575871|141599161|SUPERIORITY||Difference in Percentage|11.9||||0.0246|TWO_SIDED|95.0|2.4|21.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||21.4|2.4|0.0246
71044945|NCT03575871|141599161|SUPERIORITY||Difference in Percentage|26.9|||<|0.0001|TWO_SIDED|95.0|17.0|36.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||36.9|17.0|<0.0001
71044946|NCT03575871|141599162|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.7|3.7||P-value was not estimable since there were no events.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.7|-3.7|
71044947|NCT03575871|141599162|SUPERIORITY||Difference in Percentage|1.9||||0.2262|TWO_SIDED|95.0|-2.2|6.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.1|-2.2|0.2262
71044948|NCT03575871|141599162|SUPERIORITY||Difference in Percentage|1.9||||0.2223|TWO_SIDED|95.0|-2.2|6.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.1|-2.2|0.2223
71044949|NCT03575871|141599162|SUPERIORITY||Difference in Percentage|4.5||||0.0597|TWO_SIDED|95.0|-0.2|9.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.2|-0.2|0.0597
71044950|NCT03575871|141599162|SUPERIORITY||Difference in Percentage|1.3||||0.3207|TWO_SIDED|95.0|-2.7|5.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.2|-2.7|0.3207
71006092|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.28|||||TWO_SIDED|95.0|0.94|1.75|||||Comparison for Day 14, triglycerides|An estimation approach was used.||1.75|0.94|
71006093|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.24|||||TWO_SIDED|95.0|0.98|1.58|||||Comparison for Day 14, triglycerides|An estimation approach was used.||1.58|0.98|
71006094|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.22|||||TWO_SIDED|95.0|0.95|1.56|||||Comparison for Day 14, triglycerides|An estimation approach was used.||1.56|0.95|
71006095|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.23|||||TWO_SIDED|95.0|0.96|1.57|||||Comparison for Day 14, triglycerides|An estimation approach was used.||1.57|0.96|
71006096|NCT02202161|141520433|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.89|||||TWO_SIDED|95.0|0.72|1.11|||||Comparison for Day 14, triglycerides|An estimation approach was used.||1.11|0.72|
70925343|NCT03210272|141343884|OTHER||Geometric Mean Ratio T/R (%)|156.37|||||TWO_SIDED|90.0|132.73|184.22|||||intra-individual gCV (%) = 17.0|The statistical model to assess relative bioavailability in the FE part was an analysis of variance (ANOVA) on the ln-transformed parameters AUC and Cmax including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'||184.22|132.73|
71006097|NCT02202161|141520434|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.98|||||TWO_SIDED|95.0|0.87|1.11|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.||1.11|0.87|
71006098|NCT02202161|141520434|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.79|||||TWO_SIDED|95.0|0.71|0.89|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.||0.89|0.71|
71006099|NCT02202161|141520434|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.82|||||TWO_SIDED|95.0|0.74|0.9|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.||0.90|0.74|
71006100|NCT02202161|141520434|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|0.63|0.77|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.||0.77|0.63|
71006101|NCT02202161|141520434|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.77|||||TWO_SIDED|95.0|0.7|0.85|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.||0.85|0.70|
71006102|NCT02202161|141520434|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.97|||||TWO_SIDED|95.0|0.89|1.06|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.||1.06|0.89|
71006103|NCT02202161|141520434|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.91|||||TWO_SIDED|95.0|0.77|1.07|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.||1.07|0.77|
71006104|NCT02202161|141520434|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.81|||||TWO_SIDED|95.0|0.68|0.95|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.||0.95|0.68|
71006105|NCT02202161|141520434|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.8|||||TWO_SIDED|95.0|0.7|0.91|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.||0.91|0.70|
71006106|NCT02202161|141520434|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.67|||||TWO_SIDED|95.0|0.58|0.77|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.||0.77|0.58|
71006107|NCT02202161|141520434|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.73|||||TWO_SIDED|95.0|0.64|0.83|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.||0.83|0.64|
71006108|NCT02202161|141520434|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.9|||||TWO_SIDED|95.0|0.8|1.02|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.||1.02|0.80|
71044951|NCT03575871|141599162|SUPERIORITY||Difference in Percentage|4.5||||0.0586|TWO_SIDED|95.0|-0.2|9.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.2|-0.2|0.0586
70925344|NCT03210272|141343884|OTHER||Ratio T/R (%)|245.56|||||TWO_SIDED|90.0|200.7|300.44|||||intra-individual gCV (%) = 27.8|The statistical model to assess relative bioavailability in the FE part was an analysis of variance (ANOVA) on the ln-transformed parameters AUC and Cmax including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'||300.44|200.70|
71006109|NCT02711553|141520445|SUPERIORITY||Hazard Ratio (HR)|1.123||||0.4821|TWO_SIDED|80.0|0.904|1.395||p-value is 2-sided.|Log Rank|Stratified by geographical region, pathological diagnosis, metastatic disease.|Stratified by geographical region, pathological diagnosis, metastatic disease.|||1.395|0.904|0.4821
71006110|NCT02711553|141520445|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.6417|TWO_SIDED|80.0|0.734|1.153||p-value is 2-sided.|Log Rank|Stratified by geographical region, pathological diagnosis, metastatic disease.|Stratified by geographical region, pathological diagnosis, metastatic disease.|||1.153|0.734|0.6417
71006111|NCT02711553|141520446|SUPERIORITY||Hazard Ratio (HR)|1.336||||0.087|TWO_SIDED|95.0|0.959|1.862|||Log Rank|Stratified by geographical region, pathological diagnosis, metastatic disease.|Stratified by geographical region, pathological diagnosis, metastatic disease.|||1.862|0.959|0.0870
71044952|NCT03575871|141599162|SUPERIORITY||Difference in Percentage|5.2||||0.0419|TWO_SIDED|95.0|0.3|10.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||10.1|0.3|0.0419
71044953|NCT03575871|141599162|SUPERIORITY||Difference in Percentage|6.3||||0.0244|TWO_SIDED|95.0|1.2|11.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.4|1.2|0.0244
71006112|NCT02711553|141520446|SUPERIORITY||Hazard Ratio (HR)|0.948||||0.7599|TWO_SIDED|95.0|0.669|1.342|||Log Rank|Stratified by geographical region, pathological diagnosis, metastatic disease.|Stratified by geographical region, pathological diagnosis, metastatic disease.|||1.342|0.669|0.7599
71006113|NCT02711553|141520447|SUPERIORITY||Odds Ratio (OR)|1.0||||0.878|TWO_SIDED|95.0|0.6|1.9|||Exact Cochran-Mantel-Haenszel|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|||1.9|0.6|0.878
71006114|NCT02711553|141520447|SUPERIORITY||Odds Ratio (OR)|0.5||||0.023|TWO_SIDED|95.0|0.2|0.9|||Exact Cochran-Mantel-Haenszel|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|||0.9|0.2|0.023
71006115|NCT02711553|141520448|SUPERIORITY||Odds Ratio (OR)|1.2||||0.68|TWO_SIDED|95.0|0.6|2.4|||Exact Cochran-Mantel-Haenszel|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|||2.4|0.6|0.680
71006116|NCT02711553|141520448|SUPERIORITY||Odds Ratio (OR)|1.3||||0.499|TWO_SIDED|95.0|0.6|2.6|||Exact Cochran-Mantel-Haenszel|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|||2.6|0.6|0.499
71006117|NCT02711553|141520452|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.6||0.069|TWO_SIDED|95.0|-2.28|0.09||p-values are from Type 3 sums of squares mixed model repeated measures (MMRM) Model.|MMRM Model|Least Squares (LS) Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||PWB||0.09|-2.28|0.069
71006118|NCT02711553|141520452|SUPERIORITY||LS Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.6||0.042|TWO_SIDED|95.0|-2.42|-0.04||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||PWB||-0.04|-2.42|0.042
71006119|NCT02711553|141520452|SUPERIORITY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.51||0.112|TWO_SIDED|95.0|-1.83|0.19||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||SWB||0.19|-1.83|0.112
71006120|NCT02711553|141520452|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.51||0.505|TWO_SIDED|95.0|-1.35|0.67||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||SWB||0.67|-1.35|0.505
71006121|NCT02711553|141520452|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.44||0.116|TWO_SIDED|95.0|-1.56|0.17||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||EWB||0.17|-1.56|0.116
71006122|NCT02711553|141520452|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.45||0.521|TWO_SIDED|95.0|-1.16|0.59||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||EWB||0.59|-1.16|0.521
71006123|NCT02711553|141520452|SUPERIORITY||LS Mean Difference|-1.66|STANDARD_ERROR_OF_MEAN|0.62||0.008|TWO_SIDED|95.0|-2.87|-0.44||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||FWB||-0.44|-2.87|0.008
71006124|NCT02711553|141520452|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.62||0.335|TWO_SIDED|95.0|-1.82|0.62||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||FWB||0.62|-1.82|0.335
71006125|NCT02711553|141520452|SUPERIORITY||LS Mean Difference|-2.93|STANDARD_ERROR_OF_MEAN|0.89||0.001|TWO_SIDED|95.0|-4.69|-1.18||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||HCS||-1.18|-4.69|0.001
71006126|NCT02711553|141520452|SUPERIORITY||LS Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.89||0.068|TWO_SIDED|95.0|-3.4|0.12||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||HCS||0.12|-3.40|0.068
71006127|NCT02711553|141520452|SUPERIORITY||LS Mean Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.52||0.051|TWO_SIDED|95.0|-2.04|0.0||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||FACT-Hep||0.00|-2.04|0.051
71006128|NCT02711553|141520452|SUPERIORITY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.52||0.212|TWO_SIDED|95.0|-1.68|0.38||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||FACT-Hep||0.38|-1.68|0.212
71006129|NCT02711553|141520452|SUPERIORITY||LS Mean Difference|-5.67|STANDARD_ERROR_OF_MEAN|1.84||0.002|TWO_SIDED|95.0|-9.3|-2.04||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||TOI||-2.04|-9.30|0.002
71006130|NCT02711553|141520452|SUPERIORITY||LS Mean Difference|-3.42|STANDARD_ERROR_OF_MEAN|1.85||0.066|TWO_SIDED|95.0|-7.07|0.22||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||TOI||0.22|-7.07|0.066
71006131|NCT05559203|141520459|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.752|||||||t-test, 2 sided|paired sample||Feasibility study so no power calculation. N = 18 with baseline and follow-up data.||||.752
71044954|NCT03575871|141599163|SUPERIORITY||Difference in Percentage|25.0|||<|0.0001|TWO_SIDED|95.0|14.8|35.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.2|14.8|<0.0001
71044955|NCT03575871|141599163|SUPERIORITY||Difference in Percentage|44.2|||<|0.0001|TWO_SIDED|95.0|33.9|54.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||54.6|33.9|<0.0001
71044956|NCT03575871|141599163|SUPERIORITY||Difference in Percentage|30.2|||<|0.0001|TWO_SIDED|95.0|17.5|42.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||42.8|17.5|<0.0001
71044957|NCT03575871|141599163|SUPERIORITY||Difference in Percentage|49.8|||<|0.0001|TWO_SIDED|95.0|37.8|61.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||61.7|37.8|<0.0001
71044958|NCT03575871|141599163|SUPERIORITY||Difference in Percentage|31.5|||<|0.0001|TWO_SIDED|95.0|18.8|44.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||44.3|18.8|<0.0001
71006132|NCT05559203|141520460|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.197|||||||t-test, 2 sided|||Feasibility study so no power calculation. N = 18 with baseline and follow-up data.||||.197
71006133|NCT05559203|141520461|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.562|||||||t-test, 2 sided|||||||.562
71044959|NCT03575871|141599163|SUPERIORITY||Difference in Percentage|47.6|||<|0.0001|TWO_SIDED|95.0|35.7|59.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||59.6|35.7|<0.0001
71101819|NCT01272219|141711306|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.34|||<|0.0001|TWO_SIDED|95.0|3.54|5.32|||Regression, Logistic||The model included treatment, country, sex, pre-diabetes status at screening, BMI stratum and an interaction between pre-diabetes status at screening and BMI stratum as fixed factors, and the baseline value as covariate.|Null-hypothesis: no treatment difference between treatment arms, i.e. liraglutide 3.0 mg and liraglutide placebo. Liraglutide 3.0 mg was considered superior to placebo in inducing and maintaining weight loss as assessed by the proportion of subjects losing \>10% of their fasting baseline weight, if the estimated odds ratio (liraglutide 3.0 mg/liraglutide placebo) was statistically significantly greater than one.||5.32|3.54|<0.0001
71101820|NCT01272219|141711307|SUPERIORITY_OR_OTHER||Treatment estimate|2.681|||<|0.0001|TWO_SIDED|95.0|1.856|3.872|||Weibull analysis||The treatment estimate was the factor that the time to event is multiplied with for liraglutide 3.0 mg compared to placebo.|If the estimated time-to-event ratio (liraglutide 3.0 mg/ placebo), as assessed by the survival endpoint describing the time until onset of T2DM ('diabetes-free time'), is statistically significantly \>1, then liraglutide 3.0 mg was to be considered superior to placebo in delaying the onset of T2DM in subjects with pre-diabetes at baseline. Weibull model was used; included treatment, sex and BMI stratification factor as fixed factors and baseline FPG as a covariate.||3.872|1.856|<.0001
71006134|NCT05559203|141520462|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.02|||||||t-test, 2 sided|||Anxiety subscale||||.020
71006135|NCT05559203|141520462|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.002|||||||t-test, 2 sided|||Depression subscale||||.002
71006136|NCT05559203|141520463|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.036|||||||t-test, 2 sided|||||||.036
71006137|NCT05559203|141520464|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.042|||||||t-test, 2 sided|||||||.042
71006138|NCT05559203|141520465|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention|||||<|0.001|||||||t-test, 2 sided|||||||<.001
71006139|NCT05559203|141520466|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.781|||||||t-test, 2 sided|||||||.781
71006140|NCT01700140|141520497|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0000
71006141|NCT01700140|141520497|SUPERIORITY_OR_OTHER|||||||0.2284|||||||Fisher Exact|||||||0.2284
71006142|NCT01700140|141520497|SUPERIORITY_OR_OTHER|||||||0.2549|||||||Cochran-Armitage test|||||||0.2549
71006143|NCT01700140|141520498|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71006144|NCT01700140|141520498|SUPERIORITY_OR_OTHER|||||||0.1527|||||||Fisher Exact|||||||0.1527
71006145|NCT01700140|141520498|SUPERIORITY_OR_OTHER|||||||0.1864|||||||Cochran-Armitage test|||||||0.1864
71006146|NCT01700140|141520499|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.918||||0.8361|TWO_SIDED|95.0|0.266|3.172|||Generalized Wilcoxon test|||||3.172|0.266|0.8361
71006147|NCT01700140|141520499|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.423||||0.0724|TWO_SIDED|95.0|0.144|1.237|||Generalized Wilcoxon test|||||1.237|0.144|0.0724
70925345|NCT03210272|141343885|OTHER||Geometric Mean Ratio T/R (%)|158.74|||||TWO_SIDED|90.0|114.25|220.56|||||intra-individual gCV (%) = 34.8|The statistical model to assess relative bioavailability in the FE part was an analysis of variance (ANOVA) on the ln-transformed parameters AUC and Cmax including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'||220.56|114.25|
70925346|NCT03210272|141343885|OTHER||Ratio T/R (%)|246.13|||||TWO_SIDED|90.0|203.37|297.89|||||intra-individual gCV (%) = 26.2|The statistical model to assess relative bioavailability in the FE part was an analysis of variance (ANOVA) on the ln-transformed parameters AUC and Cmax including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'||297.89|203.37|
70925347|NCT05386758|141344017|OTHER||Gemetric Mean Ratio (GMR)|1.24|||||TWO_SIDED|90.0|0.94|1.64||||||||1.64|0.94|
71006148|NCT01700140|141520500|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.213||||0.6466|TWO_SIDED|95.0|0.616|2.388|||Generalized Wilcoxon test|||||2.388|0.616|0.6466
71006149|NCT01700140|141520500|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.828||||0.2701|TWO_SIDED|95.0|0.566|1.21|||Generalized Wilcoxon test|||||1.210|0.566|0.2701
71006150|NCT01700140|141520501|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete control rate after the first irradiation||||1.0000
71006151|NCT01700140|141520501|SUPERIORITY_OR_OTHER|||||||0.1051|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete control rate after the first irradiation||||0.1051
71006152|NCT01700140|141520501|SUPERIORITY_OR_OTHER|||||||0.4856|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete control rate after the second irradiation||||0.4856
71006153|NCT01700140|141520501|SUPERIORITY_OR_OTHER|||||||0.1047|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete control rate after the second irradiation||||0.1047
71006154|NCT01700140|141520501|SUPERIORITY_OR_OTHER|||||||0.1617|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete control rate after the third irradiation||||0.1617
71006155|NCT01700140|141520501|SUPERIORITY_OR_OTHER|||||||0.3099|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete control rate after the third irradiation||||0.3099
71006156|NCT01700140|141520502|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete response rate after the first irradiation||||1.0000
71006157|NCT01700140|141520502|SUPERIORITY_OR_OTHER|||||||0.1051|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete response rate after the first irradiation||||0.1051
71006158|NCT01700140|141520502|SUPERIORITY_OR_OTHER|||||||0.6761|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete response rate after the second irradiation||||0.6761
71006159|NCT01700140|141520502|SUPERIORITY_OR_OTHER|||||||0.3513|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete response rate after the second irradiation||||0.3513
71006160|NCT01700140|141520502|SUPERIORITY_OR_OTHER|||||||0.206|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete response rate after the third irradiation||||0.2060
70925348|NCT05386758|141344018|OTHER||Geometric Mean Ratio (GMR)|1.21|||||TWO_SIDED|90.0|0.9|1.62||||||||1.62|0.90|
71006161|NCT01700140|141520502|SUPERIORITY_OR_OTHER|||||||0.0511|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete response rate after the third irradiation||||0.0511
71006162|NCT02573012|141520506|SUPERIORITY||Least Square Means|0.613||||0.001|TWO_SIDED|95.0|0.346|0.879|||ANCOVA|||||0.879|0.346|0.001
70925349|NCT04717492|141344050|OTHER||Cox Proportional Hazard|1.01||||0.962|TWO_SIDED|95.0|0.66|1.54||No adjustments for multiplicity were performed.|Regression, Cox|Cox proportional hazard model with inverse probability of treatment weighting as described in primary manuscript.||Time to death, or first hospitalization or revascularization event was analyzed using cox proportional hazards models with inverse probability of treatment weighting (IPTW) to reduce confounding. Missing data were imputed using multivariate imputation by chained equations with predictive mean matching.||1.54|0.66|0.962
71006163|NCT02573012|141520507|SUPERIORITY||Odds Ratio (OR)|0.5||||0.018|TWO_SIDED|95.0|0.285|0.889|||Regression, Logistic|||||0.889|0.285|0.018
71006164|NCT02573012|141520507|SUPERIORITY||Relative Risk|0.833||||0.021|TWO_SIDED|95.0|0.714|0.972|||Cochran-Mantel-Haenszel|||||0.972|0.714|0.021
71006165|NCT02573012|141520508|SUPERIORITY||Least Square Mean|2.342||||0.006|TWO_SIDED|95.0|0.661|4.023|||ANCOVA|||||4.023|0.661|0.006
71006166|NCT02573012|141520528|SUPERIORITY||Least Square Means|2.264||||0.009||95.0|0.574|3.953|||ANCOVA|||||3.953|0.574|0.009
71006167|NCT00286156|141520613|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Pairwise comparisons adjusted for multiple testing (Tukey)|ANOVA|||Null hypothesis: no difference between groups in iGFR||||<0.01
71006168|NCT02449915|141520617|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||||||0.52
71006169|NCT05325333|141520635|SUPERIORITY|Word form recall accuracy (number of words correctly recalled) on Expanding and Standard retrieval schedules at 5 mins for children with DLD||||||0.567|||||||LSD test|||||||0.567
71006170|NCT05325333|141520635|SUPERIORITY|Word form recall accuracy (number of words correctly recalled) on Expanding and Standard retrieval schedules at 5 mins for children with TD||||||0.003|||||||LSD test|||||||0.003
71006171|NCT05325333|141520636|SUPERIORITY|Word form recall accuracy (number of words correctly recalled) on Expanding and Standard retrieval schedules at one week for children with DLD||||||0.187|||||||LSD test|||||||0.187
71006172|NCT05325333|141520636|SUPERIORITY|Word form recall accuracy (number of words correctly recalled) on Expanding and Standard retrieval schedules at one week for children with TD||||||0.256|||||||LSD test|||||||0.256
71006173|NCT05325333|141520637|SUPERIORITY|Word meaning recall accuracy (number of semantic associations correctly recalled) on Expanding and Standard Retrieval Schedules at 5 Mins for DLD||||||0.747|||||||LSD test|||||||0.747
71006174|NCT05325333|141520637|SUPERIORITY|Word meaning recall accuracy (number of semantic associations correctly recalled) on Expanding and Standard Retrieval Schedules at 5 Mins for TD||||||0.031|||||||LSD test|||||||0.031
71044960|NCT03575871|141599163|SUPERIORITY||Difference in Percentage|48.7|||<|0.0001|TWO_SIDED|95.0|37.2|60.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||60.1|37.2|<0.0001
71044961|NCT03575871|141599163|SUPERIORITY||Difference in Percentage|60.1|||<|0.0001|TWO_SIDED|95.0|49.1|71.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||71.0|49.1|<0.0001
71044962|NCT03575871|141599164|SUPERIORITY||Difference in Percentage|2.5||||0.1623|TWO_SIDED|95.0|-1.7|6.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.8|-1.7|0.1623
71044963|NCT03575871|141599164|SUPERIORITY||Difference in Percentage|9.1||||0.007|TWO_SIDED|95.0|3.4|14.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||14.7|3.4|0.0070
71044964|NCT03575871|141599164|SUPERIORITY||Difference in Percentage|9.7||||0.0049|TWO_SIDED|95.0|4.0|15.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||15.4|4.0|0.0049
71044965|NCT03575871|141599164|SUPERIORITY||Difference in Percentage|22.9|||<|0.0001|TWO_SIDED|95.0|15.5|30.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||30.2|15.5|<0.0001
71044966|NCT03575871|141599164|SUPERIORITY||Difference in Percentage|14.6||||0.0013|TWO_SIDED|95.0|7.2|22.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||22.0|7.2|0.0013
71044967|NCT03575871|141599164|SUPERIORITY||Difference in Percentage|31.6|||<|0.0001|TWO_SIDED|95.0|23.1|40.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||40.1|23.1|<0.0001
71044968|NCT03575871|141599164|SUPERIORITY||Difference in Percentage|20.1||||0.0001|TWO_SIDED|95.0|11.9|28.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||28.3|11.9|0.0001
71006175|NCT05325333|141520638|SUPERIORITY|Word meaning recall accuracy (number of semantic associations correctly recalled) on Expanding and Standard Retrieval Schedules at one week for DLD||||||0.061|||||||LSD test|||||||0.061
71006176|NCT05325333|141520638|SUPERIORITY|Word meaning recall accuracy (number of semantic associations correctly recalled) on Expanding and Standard Retrieval Schedules at one week for TD||||||0.747|||||||LSD test|||||||0.747
71006177|NCT05325333|141520639|SUPERIORITY|Word recognition (number of words accurately identified) on Expanding condition and Standard Retrieval Schedules for DLD||||||0.026|||||||LSD test|||||||0.026
71044969|NCT03575871|141599164|SUPERIORITY||Difference in Percentage|33.5|||<|0.0001|TWO_SIDED|95.0|24.6|42.5|||Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||42.5|24.6|<0.0001
71044970|NCT03575871|141599165|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.7|3.7||P-value could not be calculated since percentage of participants with events was 0.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.7|-3.7|
71006178|NCT05325333|141520639|SUPERIORITY|Word recognition (number of words accurately identified) on Expanding condition and Standard Retrieval Schedules for TD||||||0.72|||||||LSD test|||||||0.720
71006179|NCT05325333|141520640|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<.0001
71006180|NCT05325333|141520641|SUPERIORITY|||||||0.673|||||||t-test, 2 sided|||||||0.673
71006181|NCT04806165|141520663|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|-0.26|STANDARD_ERROR_OF_MEAN|0.26||0.309|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis explores the effect of the motivational interviewing (MI) component on rates of treatment receipt over the entire study period. Results will help determine the proportional increase in odds of treatment seeking corresponding to receiving each chatbot component. Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||.309
71101821|NCT03131479|141711316|EQUIVALENCE|Change from baseline was analyzed using a repeated measures model which included diabetic status, renal function, day and renal function\*day and diabetic status\*day as fixed factors and age, baseline body weight and baseline fasting plasma glucose as covariates.|adjusted arithmetic mean difference|-9.21||||0.154|TWO_SIDED|90.0|-19.88|1.45|||Regression, Logistic|An unstructured variance-covariance structure was used. Baseline is defined to be the measurement collected on Day -1.||||1.45|-19.88|0.154
71101822|NCT03131479|141711316|EQUIVALENCE|Change from baseline was analyzed using a repeated measures model which included diabetic status, renal function, day and renal function\*day and diabetic status\*day as fixed factors and age, baseline body weight and baseline fasting plasma glucose as covariates.|adjusted arithmetic mean difference|-6.05||||0.343|TWO_SIDED|90.0|-16.65|4.55|||Regression, Logistic|||||4.55|-16.65|0.343
71101823|NCT03131479|141711316|EQUIVALENCE|Change from baseline was analyzed using a repeated measures model which included diabetic status, renal function, day and renal function\*day and diabetic status\*day as fixed factors and age, baseline body weight and baseline fasting plasma glucose as covariates.|adjusted arithmetic mean difference|-21.5||||0.001|TWO_SIDED|90.0|-31.79|4.55|||Regression, Logistic|||||4.55|-31.79|0.001
71101824|NCT03131479|141711316|EQUIVALENCE|Change from baseline was analyzed using a repeated measures model which included diabetic status, renal function, day and renal function\*day and diabetic status\*day as fixed factors and age, baseline body weight and baseline fasting plasma glucose as covariates.|adjusted arithmetic mean difference|-35.6||||0|TWO_SIDED|90.0|-46.0|-25.11|||Regression, Logistic|||||-25.11|-46.00|0.000
71101825|NCT02899754|141711383|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Primary outcome assessed at 1 month post-intervention||||0.18
71006182|NCT04806165|141520663|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|0.34|STANDARD_ERROR_OF_MEAN|0.26||0.19|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis explores the effect of the personalized recommendation (PR) component on rates of treatment receipt over the entire study period. Results will help determine the proportional increase in odds of treatment seeking corresponding to receiving each chatbot component. Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||.190
71006183|NCT04806165|141520663|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.69|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis explores the effect of the psychoeducation (PE) component on rates of treatment receipt over the entire study period. Results will help determine the proportional increase in odds of treatment seeking corresponding to receiving each chatbot component. Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||.690
71006184|NCT04806165|141520663|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|0.54|STANDARD_ERROR_OF_MEAN|0.26||0.038|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis explores the effect of the repeated administration (RA) component on rates of treatment receipt over the entire study period. Results will help determine the proportional increase in odds of treatment seeking corresponding to receiving each chatbot component. Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||0.038
71044971|NCT03575871|141599165|SUPERIORITY||Difference in Percentage|1.3||||0.3261|TWO_SIDED|95.0|-2.8|5.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.3|-2.8|0.3261
71044972|NCT03575871|141599165|SUPERIORITY||Difference in Percentage|1.3||||0.3207|TWO_SIDED|95.0|-2.7|5.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.3|-2.7|0.3207
71101826|NCT02899754|141711385|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71101827|NCT02899754|141711386|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
71101828|NCT02899754|141711387|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
71101829|NCT02899754|141711388|SUPERIORITY|||||||0.22|||||||t-test, 2 sided|||||||0.22
71006185|NCT04806165|141520663|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.735|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis provides results on the 2 week time point post Intervention and contributes to understanding of the effect of time since chatbot engagement on treatment receipt, regardless of the combination of the four chatbot components participants were assigned (ie., component turned off or on). Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||.735
71006186|NCT04806165|141520663|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|-0.91|STANDARD_ERROR_OF_MEAN|0.27||0.001|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis provides results on the 6 week time point post Intervention and contributes to understanding of the effect of time since chatbot engagement on treatment receipt, regardless of the combination of the four chatbot components participants were assigned (ie., component turned off or on). Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||.001
71006187|NCT04806165|141520663|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|-0.73|STANDARD_ERROR_OF_MEAN|0.3||0.014|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis provides results on the 14 week time point post Intervention and contributes to understanding of the effect of time since chatbot engagement on treatment receipt, regardless of the combination of the four chatbot components participants were assigned (ie., component turned off or on). Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||.014
71006188|NCT04806165|141520664|SUPERIORITY|Gender, age, and race were included as auxiliary variables to improve imputation quality. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. For sensitivity analysis, models were run again using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.53||||0.25|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|||Analyses were conducted to determine the effects of each of the four chatbot components on secondary outcomes. This analysis in particular explores the effects of the motivational interviewing component (MI) on participant willingness to seek psychotherapy for concerns their disordered weight and shape behaviors and thoughts since engagement with the intervention. Linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||||0.25
71101830|NCT02899754|141711389|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||||||0.18
71101831|NCT02899754|141711390|SUPERIORITY|||||||0.01|||||||Chi-squared|||chi-square test||||0.01
71101832|NCT02899754|141711391|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||||||0.64
71101833|NCT02514746|141711426|OTHER||Difference (Group A - B)|-0.6|||||TWO_SIDED|95.0|-7.5|4.5||||||Difference at Year 3||4.5|-7.5|
71101834|NCT02514746|141711426|OTHER||Difference (Group A - B)|0.6|||||TWO_SIDED|95.0|-7.4|6.5||||||Difference at Year 4||6.5|-7.4|
71101835|NCT02514746|141711427|OTHER||GMT Ratio (Group A/B)|1.0|||||TWO_SIDED|95.0|0.9|1.1||||||Geometric mean titer ratio at Year 3||1.1|0.9|
71101836|NCT02514746|141711427|OTHER||GMT Ratio (Group A/B)|1.0|||||TWO_SIDED|95.0|0.9|1.1||||||Geometric mean titer ratio at Year 4||1.1|0.9|
71101837|NCT02514746|141711428|OTHER||Difference (Group A - B)|-3.7|||||TWO_SIDED|95.0|-8.1|2.8||||||Difference at 7 days post booster vaccination||2.8|-8.1|
71008654|NCT02055976|141525238|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.8224|STANDARD_ERROR_OF_MEAN|2.1126||0.349|TWO_SIDED|95.0|-3.3733|5.0182|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||5.0182|-3.3733|0.349
71044973|NCT03575871|141599165|SUPERIORITY||Difference in Percentage|3.9||||0.081|TWO_SIDED|95.0|-0.8|8.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||8.5|-0.8|0.0810
71101838|NCT02514746|141711428|OTHER||Difference (Group A - B)|-1.3|||||TWO_SIDED|95.0|-3.3|3.0||||||Difference at 28 days post booster vaccination||3.0|-3.3|
71101839|NCT02514746|141711429|OTHER||GMT Ratio (Group A/B)|0.7|||||TWO_SIDED|95.0|0.5|1.0||||||Geometric mean titer ratio 7 days after booster dose||1.0|0.5|
71101840|NCT02514746|141711429|OTHER||GMT Ratio (Group A/B)|0.7|||||TWO_SIDED|95.0|0.6|0.9||||||Geometric mean titer ratio 28 days after booster dose||0.9|0.6|
71101841|NCT02514746|141711430|OTHER||Difference (Group A - B)|-2.9|||||TWO_SIDED|95.0|-8.0|4.5||||||Difference at 7 days post booster vaccination||4.5|-8.0|
71101842|NCT02514746|141711430|OTHER||Difference (Group A - B)|-1.8|||||TWO_SIDED|95.0|-4.4|3.0||||||Difference at 28 days post booster vaccination||3.0|-4.4|
71101843|NCT02181413|141711436|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.002|TWO_SIDED|95.0|0.582|0.89|||Log Rank|P-value was based on log-rank test stratified by pre-induction regimen, International Staging System (ISS) stage and response after transplantation.|HR was based on Cox's proportional hazard regression model stratified by pre-induction regimen, pre-induction ISS stage and response after transplantation. \<1 HR indicates better prevention of progression in Ixazomib arm compared to Placebo.|||0.890|0.582|0.002
71101844|NCT02181413|141711437|SUPERIORITY||Hazard Ratio (HR)|1.025||||0.85|TWO_SIDED|95.0|0.789|1.332||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||1.332|0.789|0.850
71101845|NCT02181413|141711438|SUPERIORITY||Odds Ratio (OR)|0.732||||0.37|TWO_SIDED|95.0|0.365|1.466||P-value is based on Cochran-Mantel-Haenszel (CMH) test stratified by pre-induction regimen, pre-induction international staging system (ISS), and response after transplantation at screening.|Cochran-Mantel-Haenszel||Odds ratio and CI are based on a logistic regression model with treatment group as a categorical predictor variable and pre-induction regimen, pre-induction ISS, and response after transplantation at screening as covariates.|CR||1.466|0.365|0.370
71101846|NCT02181413|141711439|SUPERIORITY||Hazard Ratio (HR)|0.716||||0.002|TWO_SIDED|95.0|0.579|0.886||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||0.886|0.579|0.002
71101847|NCT02181413|141711440|SUPERIORITY||Hazard Ratio (HR)|1.015||||0.902|TWO_SIDED|95.0|0.795|1.298||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||1.298|0.795|0.902
71101848|NCT02181413|141711441|SUPERIORITY||Hazard Ratio (HR)|0.833||||0.056|TWO_SIDED|95.0|0.69|1.005|||Log Rank|P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||1.005|0.690|0.056
71101849|NCT02181413|141711442|SUPERIORITY||Hazard Ratio (HR)|0.922||||0.431|TWO_SIDED|95.0|0.753|1.129||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage, and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||1.129|0.753|0.431
71101850|NCT02181413|141711443|SUPERIORITY||Hazard Ratio (HR)|1.179|||||TWO_SIDED|95.0|0.959|1.45|||||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||1.450|0.959|
71101851|NCT02181413|141711445|SUPERIORITY|||||||0.814||||||P-value was based on Fisher's exact test comparing conversion to MRD- at any time post study entry between treatment groups.|Fisher Exact|||||||0.814
71101852|NCT02181413|141711446|SUPERIORITY|||||||0.805||||||P-value was based on fisher's exact test comparing conversion to MRD- at any time post study entry between treatment groups.|Fisher Exact|||||||0.805
71101853|NCT02181413|141711447|SUPERIORITY||Hazard Ratio (HR)|0.612||||0.034|TWO_SIDED|95.0|0.386|0.969||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|MRD- at Study Entry||0.969|0.386|0.034
71101854|NCT02181413|141711447|SUPERIORITY||Hazard Ratio (HR)|0.704||||0.01|TWO_SIDED|95.0|0.539|0.92||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|MRD+ at Study Entry||0.920|0.539|0.010
71101855|NCT02181413|141711448|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.182|TWO_SIDED|95.0|0.414|1.184||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|MRD- at Study Entry||1.184|0.414|0.182
71101856|NCT02181413|141711448|SUPERIORITY||Hazard Ratio (HR)|0.966||||0.847|TWO_SIDED|95.0|0.682|1.368||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|MRD+ at Study Entry||1.368|0.682|0.847
71101857|NCT02181413|141711449|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.905|TWO_SIDED|95.0|0.583|1.613||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||1.613|0.583|0.905
71101858|NCT02181413|141711454|SUPERIORITY||Least Squares (LS) Mean Difference|-2.3||||0.074|TWO_SIDED|95.0|-4.9|0.2|||t-test, 2 sided|P-value was from the significance test for the coefficient of the interaction between treatment and visit.||||0.2|-4.9|0.074
71101859|NCT02214212|141711467|SUPERIORITY||Slope|-0.16||||0.955|TWO_SIDED|95.0|-5.69|5.37|||Mixed Models Analysis|Mixed-effects model used an unstructured correlation matrix, adjusting for treatment, time (linear) and the interaction as fixed effects.|The reported effect size has been expressed as the modelled difference in sleep efficiency improvement from day 1 to day 10. A positive effect size indicates a higher score in the white-light arm.|||5.37|-5.69|.955
71101860|NCT02214212|141711468|SUPERIORITY||Mean Difference (Net)|0.69||||0.807|TWO_SIDED|95.0|-4.9|6.29|||Mixed Models Analysis|||||6.29|-4.90|.807
71101861|NCT02214212|141711469|SUPERIORITY||Mean Difference (Net)|-0.48||||0.847|TWO_SIDED|95.0|-5.38|4.43|||Mixed Models Analysis|Mixed-effects model adjusts for treatment, time (pre/post), site, FIM admit cognitive/motor, and the treatment/time as fixed effects.||||4.43|-5.38|.847
71101862|NCT02214212|141711470|SUPERIORITY||Mean Difference (Net)|3.14||||0.252|TWO_SIDED|95.0|-2.29|8.56|||Mixed Models Analysis|Statistical significance by mixed-effects regression adjusts for time (pre/post), site, FIM admit cognitive, FIM admit motor as fixed effects.||||8.56|-2.29|.252
71101863|NCT02214212|141711471|SUPERIORITY||Mean Difference (Net)|0.67||||0.722|TWO_SIDED|95.0|-3.08|4.4|||Mixed Models Analysis|||||4.4|-3.08|.722
71006189|NCT04806165|141520664|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.36||||0.44|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the effects of each of the four chatbot components on willingness to seek psychotherapy. This analysis in particular explores the effects of the psychoeducation component (PE) on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||0.44
71101864|NCT02214212|141711472|SUPERIORITY||Mean Difference (Net)|-2.25||||0.253|TWO_SIDED|95.0|-6.13|1.64|||Mixed Models Analysis|||||1.64|-6.13|.253
71101865|NCT02214212|141711473|SUPERIORITY||Mean Difference (Net)|-0.39||||0.351|TWO_SIDED|95.0|-1.21|0.44|||Mixed Models Analysis|Mixed-effects model adjusts for treatment, time (pre/post), site, FIM admit cognitive/motor, and the treatment/time as fixed effects.|A positive effect size indicates a higher score in the bright white light (BWL) intervention arm.|||0.44|-1.21|.351
71101866|NCT02214212|141711474|SUPERIORITY||Slope|0.0||||0.91|TWO_SIDED|95.0|-0.03|0.03|||Mixed Models Analysis|Mixed-effects model used an unstructured correlation matrix, adjusting for treatment, time (linear) and the interaction as fixed effects|The reported effect size has been expressed as the modelled difference in the Makley scale score improvement from day 1 to day 10. A positive effect size indicates a higher score in the white-light arm.|||0.03|-0.03|.910
71101867|NCT02214212|141711475|SUPERIORITY||Mean Difference (Net)|0.857||||0.19|TWO_SIDED|95.0|-1.93|2.32|||Mixed Models Analysis|Mixed-effects model adjusts for treatment time (pre/post)||||2.32|-1.93|0.19
71101868|NCT02214212|141711476|SUPERIORITY||Mean Difference (Net)|-4.8||||0.345|TWO_SIDED|95.0|-14.83|5.24|||Mixed Models Analysis|Mixed-effects model adjusts for treatment, time (pre/post), FIM admit cognitive, site, FIM admit motor as mixed effects.||||5.24|-14.83|.345
71101869|NCT04903093|141711480|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of adjusted geometric means|96.96|||||TWO_SIDED|90.0|85.43|110.03||||||Test: Abrocitinib 200 mg oral suspension formulation 1; Reference: Abrocitinib 200 mg commercial tablet||110.03|85.43|
71006190|NCT04806165|141520664|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.25||||0.44|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the effects of each of the four chatbot components on willingness to seek psychotherapy. This analysis in particular explores the effects of the personalized recommendation component (PR) on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||0.44
71101870|NCT04903093|141711480|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio (%) of adjusted geometric means|62.87|||||TWO_SIDED|90.0|54.85|72.07||||||Test: Famotidine 40 mg tablet + Abrocitinib 200 mg commecial tablet; Reference: Abrocitinib 200 mg commercial tablet||72.07|54.85|
71006191|NCT04806165|141520664|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.29||||0.53|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the effects of each of the four chatbot components on willingness to seek psychotherapy. This analysis in particular explores the effects of the repeated administration component (RA) on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||0.53
71006192|NCT04806165|141520664|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.53||||0.07|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis provides results on the 2 week time point post Intervention and contributes to understanding of the effect of time since chatbot engagement on willingness to seek psychotherapy, regardless of the combination of the four chatbot components participants were assigned (ie., component turned off or on).||||0.07
71006193|NCT04806165|141520664|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-1.06||||0.01|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis provides results on the 6 week time point post Intervention and contributes to understanding of the effect of time since chatbot engagement on willingness to seek psychotherapy, regardless of the combination of the four chatbot components participants were assigned (ie., component turned off or on).||||0.01
71006194|NCT04806165|141520664|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.85||||0.042|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis provides results on the 14 week time point post Intervention and contributes to understanding of the effect of time since chatbot engagement on willingness to seek psychotherapy, regardless of the combination of the four chatbot components participants were assigned (ie., component turned off or on).||||0.042
71101871|NCT04903093|141711481|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of adjusted geometric means|100.07|||||TWO_SIDED|90.0|80.28|124.74||||||Test: Abrocitinib 200 mg oral suspension formulation 1; Reference: Abrocitinib 200 mg commercial tablet||124.74|80.28|
71101872|NCT04903093|141711481|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of adjusted geometric means|15.53|||||TWO_SIDED|90.0|12.46|19.36||||||Test: Famotidine 40 mg tablet + Abrocitinib 200 mg commercial tablet; Reference: Abrocitinib 200 mg commercial tablet||19.36|12.46|
71101873|NCT03555994|141711500|SUPERIORITY||Least square mean difference|-105.7||||0.023||90.0|-178.8|-32.6|||ANCOVA|||||-32.6|-178.8|0.023
71008655|NCT02055976|141525238|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.3254|STANDARD_ERROR_OF_MEAN|2.7702||0.202|TWO_SIDED|95.0|-3.1801|7.831|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.8310|-3.1801|0.202
71008656|NCT02055976|141525238|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.1048|STANDARD_ERROR_OF_MEAN|2.7784||0.015|TWO_SIDED|95.0|0.5833|11.6263|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||11.6263|0.5833|0.015
71044974|NCT03575871|141599165|SUPERIORITY||Difference in Percentage|1.3||||0.3207|TWO_SIDED|95.0|-2.7|5.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.2|-2.7|0.3207
71044975|NCT03575871|141599165|SUPERIORITY||Difference in Percentage|3.8||||0.081|TWO_SIDED|95.0|-0.7|8.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||8.4|-0.7|0.0810
71044976|NCT03575871|141599165|SUPERIORITY||Difference in Percentage|5.2||||0.0419|TWO_SIDED|95.0|0.3|10.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||10.1|0.3|0.0419
71044977|NCT03575871|141599165|SUPERIORITY||Difference in Percentage|7.0||||0.018|TWO_SIDED|95.0|1.8|12.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||12.2|1.8|0.0180
71044978|NCT03575871|141599166|SUPERIORITY||Difference in LS mean|-30.2|||<|0.0001|TWO_SIDED|95.0|-38.1|-22.3|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-22.3|-38.1|<0.0001
71044979|NCT03575871|141599166|SUPERIORITY||Difference in LS mean|-42.3|||<|0.0001|TWO_SIDED|95.0|-50.3|-34.4|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-34.4|-50.3|<0.0001
71044980|NCT03575871|141599166|SUPERIORITY||Difference in LS mean|-29.9|||<|0.0001|TWO_SIDED|95.0|-38.1|-21.7|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-21.7|-38.1|<0.0001
71044981|NCT03575871|141599166|SUPERIORITY||Difference in LS mean|-44.6|||<|0.0001|TWO_SIDED|95.0|-52.8|-36.3|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-36.3|-52.8|<0.0001
71044982|NCT03575871|141599166|SUPERIORITY||Difference in LS mean|-26.4|||<|0.0001|TWO_SIDED|95.0|-36.2|-16.7|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-16.7|-36.2|<0.0001
71044983|NCT03575871|141599166|SUPERIORITY||Difference in LS mean|-40.2|||<|0.0001|TWO_SIDED|95.0|-50.0|-30.4|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-30.4|-50.0|<0.0001
71044984|NCT03575871|141599166|SUPERIORITY||Difference in LS mean|-31.4|||<|0.0001|TWO_SIDED|95.0|-43.1|-19.7|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-19.7|-43.1|<0.0001
71101874|NCT03555994|141711501|SUPERIORITY||Least square mean difference|-25.87||||0.008||90.0|-40.88|-10.86|||ANCOVA|||||-10.86|-40.88|0.008
71101875|NCT03555994|141711502|SUPERIORITY||Least Square Mean difference|-21.99||||0.008||90.0|-34.55|-9.43|||ANCOVA|||||-9.43|-34.55|0.008
71101876|NCT03555994|141711503|SUPERIORITY||Least Square Mean difference|-35.06||||0.07||90.0|-66.54|-3.58|||ANCOVA|||||-3.58|-66.54|0.070
71101877|NCT03555994|141711503|SUPERIORITY||Least Square Mean difference|-11.72||||0.03||90.0|-20.13|-3.3|||ANCOVA|||||-3.30|-20.13|0.030
71101878|NCT00392288|141711515|SUPERIORITY_OR_OTHER|||||||0.2696||95.0||||Due to usage of a-priori ordered hypotheses, adjustment of p-values is not necessary. The pre-specified significance level was 0.05. The tests were carried out two-sided.|ANCOVA|ANCOVA model: Change in FEV1 = baseline FEV1 + age \[yrs\] + treatment + pooled center + previous corticosteroid therapy + holding chamber||This is an analysis of the change from baseline to week 12 or last visit. In this pairwise comparison Ciclesonide was compared with Placebo by testing the average effect of Ciclesonide 40 and Ciclesonide 80 versus Placebo. As statistical test a t-test was used to compare the corresponding least-square means of both treatment groups.||||0.2696
71101879|NCT00392288|141711515|SUPERIORITY_OR_OTHER|||||||0.0703||95.0||||Due to usage of a-priori ordered hypotheses, adjustment of p-values is not necessary. The pre-specified significance level was 0.05. The tests were carried out two-sided.|ANCOVA|ANCOVA model: Change in FEV1 = baseline FEV1 + age \[yrs\] + treatment + pooled center + previous corticosteroid therapy + holding chamber||This is an analysis of the change from baseline to week 12 or last visit. A t-test was used to compare the least-square means of Ciclesonide 80 versus Placebo.||||0.0703
70925350|NCT04717492|141344052|OTHER||Cox Proportional Hazard|1.11||||0.694|TWO_SIDED|95.0|0.65|1.92||No adjustments for multiplicity were performed.|Regression, Cox|Cox proportional hazard model with inverse probability of treatment weighting as described in primary manuscript.||Time to CVD-related death or hospitalization/revascularization was analyzed using cox proportional hazards models with inverse probability of treatment weighting (IPTW) to reduce confounding. Missing data were imputed using multivariate imputation by chained equations with predictive mean matching.||1.92|0.65|0.694
71006195|NCT04806165|141520664|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.08||||0.89|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 2-week time since engagement with the intervention and the motivational interviewing (MI) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.89
71006196|NCT04806165|141520664|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.34||||0.69|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 6-week time since engagement with the intervention and the motivational interviewing (MI) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.69
71006197|NCT04806165|141520664|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.69||||0.4|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 14-week time since engagement with the intervention and the motivational interviewing (MI) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.40
71006198|NCT04806165|141520664|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.35||||0.55|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 2-week time since engagement with the intervention and the psychoeducation (PE) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.55
71006199|NCT04806165|141520664|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.88||||0.32|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 6-week time since engagement with the intervention and the psychoeducation (PE) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.32
71008657|NCT02055976|141525238|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.2393|STANDARD_ERROR_OF_MEAN|2.7396||0.03|TWO_SIDED|95.0|-0.2058|10.6845|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.6845|-0.2058|0.030
71006200|NCT04806165|141520664|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.37||||0.63|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 14-week time since engagement with the intervention and the psychoeducation (PE) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.63
71006201|NCT04806165|141520664|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.08||||0.9|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 2-week time since engagement with the intervention and the personalized recommendation (PR) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.90
71044985|NCT03575871|141599166|SUPERIORITY||Difference in LS mean|-44.7|||<|0.0001|TWO_SIDED|95.0|-56.4|-33.0|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-33.0|-56.4|<0.0001
71044986|NCT03575871|141599167|SUPERIORITY||Difference in LS mean|-26.5|||<|0.0001|TWO_SIDED|95.0|-35.5|-17.5|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-17.5|-35.5|<0.0001
71044987|NCT03575871|141599167|SUPERIORITY||Difference in LS mean|-34.1|||<|0.0001|TWO_SIDED|95.0|-43.1|-25.1|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-25.1|-43.1|<0.0001
71044988|NCT03575871|141599167|SUPERIORITY||Difference in LS mean|-29.7|||<|0.0001|TWO_SIDED|95.0|-39.0|-20.4|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-20.4|-39.0|<0.0001
71044989|NCT03575871|141599167|SUPERIORITY||Difference in LS mean|-40.5|||<|0.0001|TWO_SIDED|95.0|-49.8|-31.1|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-31.1|-49.8|<0.0001
71044990|NCT03575871|141599167|SUPERIORITY||Difference in LS mean|-32.9|||<|0.0001|TWO_SIDED|95.0|-44.6|-21.2|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-21.2|-44.6|<0.0001
71044991|NCT03575871|141599167|SUPERIORITY||Difference in LS mean|-40.6|||<|0.0001|TWO_SIDED|95.0|-52.2|-28.9|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-28.9|-52.2|<0.0001
71044992|NCT03575871|141599167|SUPERIORITY||Difference in LS mean|-39.6|||<|0.0001|TWO_SIDED|95.0|-51.8|-27.4|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-27.4|-51.8|<0.0001
71044993|NCT03575871|141599167|SUPERIORITY||Difference in LS mean|-48.2|||<|0.0001|TWO_SIDED|95.0|-60.4|-36.0|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-36.0|-60.4|<0.0001
71044994|NCT03575871|141599168|SUPERIORITY||Difference in Percentage|1.9||||0.2353|TWO_SIDED|95.0|-2.2|6.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.0|-2.2|0.2353
71044995|NCT03575871|141599168|SUPERIORITY||Difference in Percentage|5.8||||0.0332|TWO_SIDED|95.0|0.8|10.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||10.8|0.8|0.0332
71044996|NCT03575871|141599168|SUPERIORITY||Difference in Percentage|6.5||||0.0227|TWO_SIDED|95.0|1.4|11.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.6|1.4|0.0227
71044997|NCT03575871|141599168|SUPERIORITY||Difference in Percentage|16.8||||0.0001|TWO_SIDED|95.0|10.1|23.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.5|10.1|0.0001
71006202|NCT04806165|141520664|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.95||||0.27|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 6-week time since engagement with the intervention and the personalized recommendation (PR) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.27
71006203|NCT04806165|141520664|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.67||||0.42|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 14-week time since engagement with the intervention and the personalized recommendation (PR) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.42
71008658|NCT02055976|141525238|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.1827|STANDARD_ERROR_OF_MEAN|2.4251||0.185|TWO_SIDED|95.0|-2.6334|6.9988|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||6.9988|-2.6334|0.185
71008659|NCT02055976|141525238|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.1376|STANDARD_ERROR_OF_MEAN|2.4716||0.195|TWO_SIDED|95.0|-2.7718|7.0469|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.0469|-2.7718|0.195
71044998|NCT03575871|141599168|SUPERIORITY||Difference in Percentage|14.5||||0.0008|TWO_SIDED|95.0|7.7|21.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||21.3|7.7|0.0008
71044999|NCT03575871|141599168|SUPERIORITY||Difference in Percentage|25.8|||<|0.0001|TWO_SIDED|95.0|18.1|33.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||33.4|18.1|<0.0001
71045000|NCT03575871|141599168|SUPERIORITY||Difference in Percentage|18.5||||0.0003|TWO_SIDED|95.0|10.5|26.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||26.5|10.5|0.0003
71045001|NCT03575871|141599168|SUPERIORITY||Difference in Percentage|30.2|||<|0.0001|TWO_SIDED|95.0|21.4|39.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||39.0|21.4|<0.0001
71045002|NCT03575871|141599169|SUPERIORITY||Difference in Percentage|12.7||||0.0011|TWO_SIDED|95.0|6.5|18.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||18.9|6.5|0.0011
71045003|NCT03575871|141599169|SUPERIORITY||Difference in Percentage|32.6|||<|0.0001|TWO_SIDED|95.0|24.6|40.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||40.6|24.6|<0.0001
71045004|NCT03575871|141599169|SUPERIORITY||Difference in Percentage|28.3|||<|0.0001|TWO_SIDED|95.0|18.5|38.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.2|18.5|<0.0001
71101880|NCT00392288|141711515|SUPERIORITY_OR_OTHER|||||||0.9146||95.0||||Due to usage of a-priori ordered hypotheses, adjustment of p-values is not necessary. The pre-specified significance level was 0.05. The tests were carried out two-sided.|ANCOVA|ANCOVA model: Change in FEV1 = baseline FEV1 + age \[yrs\] + treatment + pooled center + previous corticosteroid therapy + holding chamber||This is an analysis of the change from baseline to week 12 or last visit. As statistical test a t-test was used to compare the corresponding least-square means of Ciclesonide 40 versus Placebo.||||0.9146
71101881|NCT02544763|141711518|SUPERIORITY||Percentage reduction|48.6|||||TWO_SIDED|95.0|40.4|55.8||||||||55.8|40.4|
71101882|NCT02544763|141711518|SUPERIORITY||Percentage reduction|47.5|||||TWO_SIDED|95.0|39.0|54.8||||||||54.8|39.0|
71101883|NCT02544763|141711518|SUPERIORITY||Percentage reduction|26.5|||||TWO_SIDED|95.0|14.9|36.5||||||||36.5|14.9|
71101884|NCT02544763|141711518|SUPERIORITY||Treatment ratio|0.699|||=|0.0009|TWO_SIDED|95.0|0.567|0.861|||Mixed Models Analysis|||||0.861|0.567|=0.0009
71045005|NCT03575871|141599169|SUPERIORITY||Difference in Percentage|52.8|||<|0.0001|TWO_SIDED|95.0|43.2|62.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||62.5|43.2|<0.0001
71045006|NCT03575871|141599169|SUPERIORITY||Difference in Percentage|28.0|||<|0.0001|TWO_SIDED|95.0|17.0|39.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||39.0|17.0|<0.0001
71045007|NCT03575871|141599169|SUPERIORITY||Difference in Percentage|46.1|||<|0.0001|TWO_SIDED|95.0|35.2|57.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||57.1|35.2|<0.0001
71101885|NCT02544763|141711518|SUPERIORITY||Treatment ratio|0.715|||=|0.0018|TWO_SIDED|95.0|0.58|0.881|||Mixed Models Analysis|||||0.881|0.580|=0.0018
71006204|NCT04806165|141520664|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|1.23||||0.04|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 2-week time since engagement with the intervention and the repeated administration (RA) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.04
71006205|NCT04806165|141520664|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|1.22||||0.16|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Multilevel Models|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 6-week time since engagement with the intervention and the repeated administration (RA) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.16
71006206|NCT04806165|141520664|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.01||||0.99|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 14-week time since engagement with the intervention and the repeated administration (RA) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.99
71008660|NCT02055976|141525238|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.3113|STANDARD_ERROR_OF_MEAN|2.4909||0.45|TWO_SIDED|95.0|-4.6358|5.2584|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||5.2584|-4.6358|0.450
71045008|NCT03575871|141599169|SUPERIORITY||Difference in Percentage|36.2|||<|0.0001|TWO_SIDED|95.0|25.4|47.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||47.1|25.4|<0.0001
71101886|NCT02544763|141711519|SUPERIORITY||Odds Ratio (OR)|1.95|||=|0.0692|TWO_SIDED|95.0|0.95|4.0|||Cochran-Mantel-Haenszel|The p-value was calculated from a Cochran-Mantel-Haenszel test stratified by age group (1-6, 7-11, 12-17 and 18-65 years).||||4.00|0.95|=0.0692
71101887|NCT02544763|141711519|SUPERIORITY||Odds Ratio (OR)|2.29|||=|0.0245|TWO_SIDED|95.0|1.12|4.67|||Cochran-Mantel-Haenszel|The p-value was calculated from a Cochran-Mantel-Haenszel test stratified by age group (1-6, 7-11, 12-17 and 18-65 years).||||4.67|1.12|=0.0245
71101888|NCT02544763|141711520|SUPERIORITY||Odds Ratio (OR)|2.25|||=|0.0074|TWO_SIDED|95.0|1.24|4.07|||nominal|The global impression of change was analyzed using an ordinal logistic regression model with treatment group as a fixed factor.||||4.07|1.24|=0.0074
71101889|NCT02544763|141711520|SUPERIORITY||Odds Ratio (OR)|1.77|||=|0.058|TWO_SIDED|95.0|0.98|3.2|||nominal|The global impression of change is analyzed using an ordinal logistic regression model with treatment group as a fixed factor.||||3.20|0.98|=0.0580
71101890|NCT02544763|141711521|SUPERIORITY|Model includes the total number of seizures as a response variable and age group, time (Baseline and treatment period), treatment and treatment by time interaction as fixed effects and participant as a random effect. The log transformed number of days seizures were reported by period is included as an offset.|Percentage reduction|0.519|||||TWO_SIDED|95.0|0.447|0.602||||||||0.602|0.447|
71101891|NCT02544763|141711521|SUPERIORITY||Percentage reduction|0.524|||||TWO_SIDED|95.0|0.452|0.607||||||||0.607|0.452|
70925351|NCT04717492|141344054|OTHER||Cox Proportional Hazard|0.75||||0.476|TWO_SIDED|95.0|0.34|1.66||No adjustments for multiplicity were performed.|Regression, Cox|Cox proportional hazard model with inverse probability of treatment weighting as described in primary manuscript.||Time to respiratory/COPD-related death or hospitalization was analyzed using Cox proportional hazards models with inverse probability of treatment weighting (IPTW) to reduce confounding. Missing data were imputed using multivariate imputation by chained equations with predictive mean matching.||1.66|0.34|0.476
70925352|NCT05071807|141344056|SUPERIORITY||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-1.17|1.33|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and BMI (kg/m2)||To detect a 1.2 percentage point (standard deviation 2.4; effect size 0.5) between-group difference in the change in FMD with 80% power (α=0.05), it was estimated that a sample size of 128 participants was needed (64 per group)||1.33|-1.17|
71006207|NCT04806165|141520665|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.07|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||We computed both unstandardized (B) and standardized (ß) coefficients to indicate effect sizes. As suggested by Fey et al. (2023), we interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the time effect of attitudinal changes over the 14 week course of the study, regardless of the combination of components participants were assigned (ie., component turned off or on). Results will help determine whether mean participant attitudes toward change for concerns related to their eating, weight, and/or shape concerns varied based on the time elapsed since engagement with the intervention (ie., do attitudinal changes post-inntervention endure over time?).||||<.001
71045009|NCT03575871|141599169|SUPERIORITY||Difference in Percentage|49.6|||<|0.0001|TWO_SIDED|95.0|38.9|60.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||60.3|38.9|<0.0001
71006208|NCT04806165|141520665|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.06|STANDARD_ERROR_OF_MEAN|0.03||0.026|TWO_SIDED|||||We computed both unstandardized (B) and standardized (ß) coefficients to indicate effect sizes. As suggested by Fey et al. (2023), we interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the interaction effects of time since intervention and each of the four chatbot components. This analysis explores the interaction effects of time and the motivational interviewing (MI) component on participant attitudes toward change for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||.026
71006209|NCT04806165|141520665|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.02|STANDARD_ERROR_OF_MEAN|0.03||0.465|TWO_SIDED|||||We computed both unstandardized (B) and standardized (ß) coefficients to indicate effect sizes. As suggested by Fey et al. (2023), we interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the interaction effects of time since intervention and each of the four chatbot components. This analysis explores the interaction effects of time and the personalized recommendation (PR) component on participant attitudes toward change for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||.465
71006210|NCT04806165|141520665|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.536|TWO_SIDED|||||We computed both unstandardized (B) and standardized (ß) coefficients to indicate effect sizes. As suggested by Fey et al. (2023), we interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the interaction effects of time since intervention and each of the four chatbot components. This analysis explores the interaction effects of time and the psychoeducation (PE) component on participant attitudes toward change for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||.536
71101892|NCT02544763|141711521|SUPERIORITY||Percentage reduction|0.731|||||TWO_SIDED|95.0|0.632|0.846||||||||0.846|0.632|
70925353|NCT05071807|141344057|SUPERIORITY||Mean Difference (Net)|-7.2|||||TWO_SIDED|95.0|-12.3|-2.1|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||-2.1|-12.3|
70925354|NCT05071807|141344058|SUPERIORITY||Mean Difference (Net)|1.1|||||TWO_SIDED|95.0|-0.8|2.9|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||2.9|-0.8|
70925355|NCT05071807|141344059|SUPERIORITY||Mean Difference (Net)|-16.4|||||TWO_SIDED|95.0|-30.0|-2.9|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||-2.9|-30.0|
70925356|NCT05071807|141344060|SUPERIORITY||Mean Difference (Net)|-75.3|||||TWO_SIDED|95.0|-144.0|-6.93|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||Total LDL particle mean difference||-6.93|-144|
70925357|NCT05071807|141344060|SUPERIORITY||Mean Difference (Net)|-27.9|||||TWO_SIDED|95.0|-69.3|13.4|||Regression, Linear|adjustment for the baseline value, age (years), sex (male or female) and body mass index (BMI) (kg/m2)||For Large LDL particle subclass||13.4|-69.3|
70925358|NCT05071807|141344061|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.56|0.75|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2).||Results for total HDL particle count||0.75|-0.56|
71006211|NCT04806165|141520665|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.049|TWO_SIDED|||||We computed both unstandardized (B) and standardized (ß) coefficients to indicate effect sizes. As suggested by Fey et al. (2023), we interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the interaction effects of time since intervention and each of the four chatbot components. This analysis explores the interaction effects of time and the repeated administration (RA) component on participant attitudes toward change for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||.049
71006212|NCT02059174|141520666|NON_INFERIORITY_OR_EQUIVALENCE|A frailty model was used with effects for treatment, period and sequence and a random effect for participant. A value of 1.00 for the hazard ratio corresponds to no difference between treatments.|Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.72|1.59|||||ratio (MK-1293 / EU-Approved Lantus)|Because numerous participants did not achieve End of Action within the 30-hour clamp timeframe, the pre-specified hypothesis of similarity with regard to mean DOA could not be tested and a survival analysis approach was undertaken. The hazard rate is a measure of the instantaneous risk of reaching End of Action at time t given End of Action has not been met up until time t, with the hazard ratio being an estimate of the relative difference in hazard rates between treatments.||1.59|0.72|
71006213|NCT02059174|141520667|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria calculated via Fieller's Theorem was 95% confidence interval for arithmetic mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Ratio of Arithmetic Means|0.95|||||TWO_SIDED|95.0|0.88|1.01|||||Ratio (MK-1293 / EU-Approved Lantus)|||1.01|0.88|
71006214|NCT02059174|141520668|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria calculated via Fieller's Theorem was 95% confidence interval for arithmetic mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Ratio of Arithmetic Means|0.9|||||TWO_SIDED|95.0|0.81|0.99|||||Ratio (MK-1293 / EU-Approved Lantus)|||0.99|0.81|
71006215|NCT02059174|141520669|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria calculated via Fieller's Theorem was 95% confidence interval for arithmetic mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Ratio of Arithmetic Means|0.99|||||TWO_SIDED|95.0|0.92|1.06|||||Ratio (MK-1293 / EU-Approved Lantus)|||1.06|0.92|
71006216|NCT02059174|141520670|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria calculated via Fieller's Theorem was 95% confidence interval for arithmetic mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Ratio of Arithmetic Means|0.96|||||TWO_SIDED|95.0|0.91|1.02|||||Ratio (MK-1293 / EU-Approved Lantus)|||1.02|0.91|
71006217|NCT02059174|141520671|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria was 90% confidence interval for geometric mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Geometric Mean Ratio|0.97|||||TWO_SIDED|90.0|0.91|1.02|||||Ratio (MK-1293 / EU-Approved Lantus)|||1.02|0.91|
71006218|NCT02059174|141520672|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria was 90% confidence interval for geometric mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Geometric Mean Ratio|0.97|||||TWO_SIDED|90.0|0.93|1.03|||||Ratio (MK-1293 / EU-Approved Lantus)|||1.03|0.93|
71006219|NCT02059174|141520673|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria was 90% confidence interval for geometric mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Geometric Mean Ratio|0.92|||||TWO_SIDED|90.0|0.86|0.97|||||Ratio (MK-1293 / EU-Approved Lantus)|||0.97|0.86|
71006220|NCT02059174|141520674|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria was 90% confidence interval for geometric mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Geometric Mean Ratio|1.0|||||TWO_SIDED|90.0|0.95|1.04|||||Ratio (MK-1293 / EU-Approved Lantus)|||1.04|0.95|
71006221|NCT01901809|141520686|SUPERIORITY||Mean Difference (Net)|11.4|STANDARD_ERROR_OF_MEAN|4.7||0.018|TWO_SIDED|95.0|2.0|20.8|||t-test, 2 sided|||||20.8|2.0|0.018
71045010|NCT03575871|141599170|SUPERIORITY||Difference in Percentage|1.9||||0.2261|TWO_SIDED|95.0|-2.2|6.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.0|-2.2|0.2261
71101893|NCT02544763|141711521|SUPERIORITY||Treatment ratio|0.709|||=|0.0013|TWO_SIDED|95.0|0.576|0.873|||Mixed Models Analysis|||||0.873|0.576|=0.0013
70925359|NCT05071807|141344061|SUPERIORITY||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.75|0.8||||Adjusted for baseline value, age, sex, and BMI||Results for Small HDL particles||0.80|-0.75|
70925360|NCT05071807|141344061|SUPERIORITY||Mean Difference (Net)|-0.33|||||TWO_SIDED|95.0|-0.85|0.19|||Regression, Linear|Adjusted for baseline value, age, sex, and BMI||Results for Medium HDL||0.19|-0.85|
70925361|NCT05071807|141344062|SUPERIORITY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-3.09|3.13|||Regression, Linear|were adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||Results from brachial systolic blood pressure are reported below||3.13|-3.09|
70925362|NCT05071807|141344062|SUPERIORITY||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-1.67|2.07|||Regression, Linear|Adjusted for baseline value, age, sex, BMI||Results for Brachial Diastolic Blood pressure||2.07|-1.67|
70925363|NCT05071807|141344063|SUPERIORITY||Mean Difference (Net)|-0.48|||||TWO_SIDED|95.0|-3.24|2.28|||Regression, Linear|Adjusted for baseline value, age, sex, BMI||Results for central systolic blood pressure||2.28|-3.24|
71006222|NCT01901809|141520687|SUPERIORITY||Mean Difference (Net)|-4.8|STANDARD_ERROR_OF_MEAN|4.8||0.33|TWO_SIDED|95.0|-14.4|4.9|||t-test, 2 sided|||||4.9|-14.4|0.33
71006223|NCT00087594|141520688|SUPERIORITY_OR_OTHER||Difference|7.0|||||TWO_SIDED|95.0|-27.8|41.3||||||95% CI for G1 participants||41.3|-27.8|
71006224|NCT00087594|141520688|SUPERIORITY_OR_OTHER||Difference|13.0|||||TWO_SIDED|95.0|-10.4|35.4||||||95% CI for G2/3 participants||35.4|-10.4|
71006225|NCT00087594|141520688|SUPERIORITY_OR_OTHER||Difference|44.0|||||TWO_SIDED|95.0|12.0|76.9||||||95% CI for G1 participants with 2 log drop at W 12||76.9|12.0|
71006226|NCT00087594|141520688|SUPERIORITY_OR_OTHER||Difference|0.0|||||TWO_SIDED|||||||||95% CI for G1 participants with non 2 log drop at W 12||||
71006227|NCT00087594|141520688|SUPERIORITY_OR_OTHER||Difference|-13.0|||||TWO_SIDED|95.0|-77.2|50.5||||||95% CI for G1 participants with missing HCV-RNA at W 12||50.5|-77.2|
71006228|NCT02776904|141520702|OTHER|||||||0.0003||||||Adjustment with Tukey-Kramer|ANOVA|3 DF||Repeated measures ANOVA compared pre-season scores to post-season, end of the school year and pre-season year 2 for Visual Memory||||0.0003
71006229|NCT02776904|141520702|OTHER|||||||0.0281||||||Adjusted for multiple comparisons using Tukey-Kramer|ANOVA|DF 3||Repeated measures ANOVA compared pre-season scores to post-season, end of the school year and pre-season year 2 for Verbal memory||||0.0281
71045011|NCT03575871|141599170|SUPERIORITY||Difference in Percentage|5.2||||0.0451|TWO_SIDED|95.0|0.3|10.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||10.0|0.3|0.0451
71045012|NCT03575871|141599170|SUPERIORITY||Difference in Percentage|7.0||||0.0171|TWO_SIDED|95.0|1.8|12.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||12.3|1.8|0.0171
71045013|NCT03575871|141599170|SUPERIORITY||Difference in Percentage|17.7|||<|0.0001|TWO_SIDED|95.0|10.9|24.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||24.5|10.9|<0.0001
71045014|NCT03575871|141599170|SUPERIORITY||Difference in Percentage|11.5||||0.0018|TWO_SIDED|95.0|5.5|17.5||P-value was adjusted by randomization strata (baseline disease severity and age category)|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||17.5|5.5|0.0018
71101894|NCT02544763|141711521|SUPERIORITY||Treatment ratio|0.716|||=|0.0018|TWO_SIDED|95.0|0.582|0.882|||Mixed Models Analysis|||||0.882|0.582|=0.0018
71101895|NCT04548219|141711523|OTHER|A linear fixed-effects model is used to estimate the relative bioavailability.|Ratio of Geometric least squares mean|0.907|||||TWO_SIDED|90.0|0.775|1.06||||||||1.06|0.775|
71101896|NCT04548219|141711524|OTHER|A linear fixed-effects model is used to estimate the relative bioavailability.|Ratio of Geometric least squares mean|0.915|||||TWO_SIDED|90.0|0.761|1.1||||||||1.10|0.761|
71101897|NCT04548219|141711525|OTHER|A linear fixed-effects model is used to estimate the relative bioavailability.|Ratio of Geometric least squares mean|0.915|||||TWO_SIDED|90.0|0.76|1.1||||||||1.10|0.760|
71101898|NCT02613507|141711526|SUPERIORITY|||||||0.0006|TWO_SIDED|||||The boundary for statistical significance requires the p-value to be less than 0.0231|Stratified weighted Log-Rank|Stratified weighted using G \[rho=0, gamma=1\] Fleming and Harrington.||||||0.0006
71101899|NCT02613507|141711526|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|97.7|0.52|0.9|||Stratified Cox Proportional Hazard Model|||||0.90|0.52|
71101900|NCT02613507|141711526|SUPERIORITY|||||||0.0017|||||||Log Rank|regular stratified log-rank test p-value||||||0.0017
71101901|NCT03941093|141711536|OTHER||Hazard Ratio (HR)|1.08||||0.5487|TWO_SIDED|95.0|0.83|1.41|||Stratified Log Rank Test|||||1.41|0.83|0.5487
71006230|NCT02776904|141520702|OTHER|||||||0.0035||||||Adjusted for multiple comparisons|ANOVA|DF 3||Repeated measures ANOVA compared pre-season scores to post-season, end of the school year and pre-season year 2 for Visual Motor composite||||0.0035
71006231|NCT02776904|141520703|OTHER|||||||0.2637||||||Adjusted for multiple comparisons using Tukey-Kramer|ANOVA|||Repeated measures ANOVA compared pre-season scores to post-season, end of the school year and pre-season year 2 for Reaction Time||||0.2637
71006232|NCT02776904|141520704|OTHER||||||<|0.001||||||Used Tukey's Adjustment|ANOVA|||Descriptive analysis, including means and standard deviations was used to summarize all participant data. Velocity was normalized to leg length. Normality was tested and assumed for all measured gait parameters for healthy athletes. A two-way repeated measure analyses of variance (ANOVA) was used to explore the impact of walk status and sex on gait velocity for healthy athletes. Adjusted using Tukey's post hoc method for the pairwise comparisons (0.05 threshold for significance)||||<0.001
71006233|NCT02776904|141520705|OTHER|Normality was tested and assumed for all measured gait parameters. A two-way repeated measure analyses of variance (ANOVA) was used to explore the impact of walk status and sex on gait parameters of step length. Adjusted using Tukey's post hoc method for the pairwise comparisons (0.05 threshold for significance).|||||<|0.0001|||||||ANOVA|Tukey's post hoc method for the pair wise comparisons between walk status and sex for step length.||||||< 0.0001
71006234|NCT02776904|141520706|OTHER|Normality was tested and assumed for all measured gait parameters. A two-way repeated measure analyses of variance (ANOVA) was used to explore the impact of walk status and sex on percent of gait cycle in DLS.|||||<|0.0001|||||||ANOVA|Tukey's post hoc method for the pairwise comparisons with p\<.05.||||||< 0.0001
71006235|NCT02776904|141520707|OTHER|Normality was tested and assumed for all measured gait parameters. A two-way repeated measure analyses of variance (ANOVA) was used to explore the impact of walk status and sex on percent of gait cycle in SLS.|||||<|0.0001|||||||ANOVA|Tukey's post hoc method for pairwise comparison between walk status and sex for %GC in SLS.||||||< 0.0001
71006236|NCT02776904|141520708|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
71006237|NCT02776904|141520709|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
71006238|NCT02776904|141520710|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
71006239|NCT01952041|141520712|SUPERIORITY|||||||0.8|||||||Chi-squared|Chi-square test statistic=0.06, degrees of freedom=2||||||0.80
71006240|NCT01952041|141520713|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.43|TWO_SIDED|95.0|0.42|1.44|||Regression, Cox||Hazard ratio is intervention arm vs. TAU for time to first relapse from randomization. There is not a standard error (SE) that directly links to the hazard ratio. The confidence interval provided illustrates the dispersion for the hazard ratio.|||1.44|0.42|0.43
71006241|NCT01952041|141520714|SUPERIORITY||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.41||0.58|TWO_SIDED|95.0|-0.58|1.02|||Mixed Models Analysis||Treatment by time interaction terms are given to test difference of slopes between arms.|||1.02|-0.58|0.58
71006242|NCT01952041|141520715|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.12||0.84|TWO_SIDED|95.0|-0.22|0.26|||Mixed Models Analysis||Treatment by time interaction terms are given to test difference of slopes between arms.|||0.26|-0.22|0.84
71006243|NCT01952041|141520716|SUPERIORITY||Slope|-2.7|STANDARD_ERROR_OF_MEAN|1.4||0.06|TWO_SIDED|95.0|-5.4|0.04|||Mixed Models Analysis||Treatment by time interaction terms are given to test difference of slopes between arms.|||0.04|-5.40|0.06
71006244|NCT01736176|141520717|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Mixed-effect Repeated Measures (MMRM)|MMRM model included the fixed effects of study site and visit, with baseline score as a covariate, and the baseline-by-visit interaction.||The primary null hypothesis was no change in least-square (LS) mean, calculated using a mixed-effect repeated measures model (MMRM), for NMSS total score from baseline to Week 12. The statistical test was two-sided and the null hypothesis was rejected at the significance level of α = 0.050.||||< 0.001
71006245|NCT01736176|141520721|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Mixed-effect Repeated Measures (MMRM)|MMRM model included the fixed effects of study site and visit, with baseline score as a covariate, and the baseline-by-visit interaction.||||||0.004
71006246|NCT03650387|141520762|OTHER||||||<|0.0001||||||Bonferroni-Holm was used for alpha correction.|Exact one-sample binomial test|The one-sample binomial test was used to test whether the probability of being a responder (p) is significantly above 60%.||||||< 0.0001
71006247|NCT03650387|141520763|OTHER||||||<|0.0001||||||Bonferroni-Holm was used for alpha correction.|Exact one-sample binomial test|The one-sample binomial test was used to test whether the probability of being a responder (p) is significantly above 60%.||||||< 0.0001
71045015|NCT03575871|141599170|SUPERIORITY||Difference in Percentage|25.7|||<|0.0001|TWO_SIDED|95.0|18.3|33.1||P-value was adjusted by randomization strata (baseline disease severity and age category)|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||33.1|18.3|<0.0001
71045016|NCT03575871|141599170|SUPERIORITY||Difference in Percentage|16.2||||0.0005|TWO_SIDED|95.0|8.8|23.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.6|8.8|0.0005
71045017|NCT03575871|141599170|SUPERIORITY||Difference in Percentage|27.6|||<|0.0001|TWO_SIDED|95.0|19.3|35.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.8|19.3|<0.0001
70925364|NCT05071807|141344063|SUPERIORITY||Median Difference (Net)|0.21|||||TWO_SIDED|95.0|-1.69|2.1|||Regression, Linear|Adjusted for baseline value, age, sex, BMI||Results for central diastolic blood pressure||2.10|-1.69|
71006248|NCT03650387|141520764|OTHER||||||<|0.0001||||||Bonferroni-Holm was used for alpha correction.|Exact one-sample binomial test|The one-sample binomial test was used to test whether the probability of being a responder (p) is significantly above 60%.||||||< 0.0001
71006249|NCT02145429|141520795|OTHER||Hazard Ratio (HR)|0.32||||0.04|TWO_SIDED|95.0|0.1|0.98|||Log Rank|||||0.98|0.10|0.04
71006250|NCT02145429|141520796|OTHER||Mean Difference (Final Values)|-1.18|||<|0.001|TWO_SIDED|95.0|-2.03|-0.31|||Mixed Models Analysis|||||-0.31|-2.03|<0.001
71006251|NCT02145429|141520797|OTHER||Mean Difference (Final Values)|-0.14||||0.26|TWO_SIDED|95.0|-1.89|1.62|||Mixed Models Analysis|||||1.62|-1.89|0.26
71006252|NCT02274311|141520818|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"Measures of central tendency (mean) and variability (range and/or SD) were used to describe numeric variables. Paired Student's t test was used to verify the mean differences between dependent normally distributed variables. Wilcoxon sign test was performed to non-normally distributed dependent variables.~Asignificance level of 5%was adopted for all statistical tests (P \<.05)."||||< 0.05
71006253|NCT02477800|141520830|SUPERIORITY||Difference from Placebo|0.11||||0.225|TWO_SIDED|95.0|-0.469|0.403|||MMRM Model|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in CDR-SB as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline CDR-SB, baseline CDR-SB by visit interaction, baseline MMSE, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||0.403|-0.469|0.2250
71006254|NCT02477800|141520830|SUPERIORITY||Difference from late start group|0.03||||0.833|TWO_SIDED|95.0|-0.262|0.326|||MMRM Model|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in CDR-SB as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline CDR-SB, baseline CDR-SB by visit interaction, baseline MMSE, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||0.326|-0.262|0.8330
70925365|NCT05071807|141344064|SUPERIORITY||Mean Difference (Net)|-0.01|||||TWO_SIDED|95.0|-0.26|0.24|||Regression, Linear|were adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||0.24|-0.26|
71006255|NCT02477800|141520831|SUPERIORITY||Difference from Placebo|0.2||||0.4795|TWO_SIDED|95.0|-0.35|0.74|||MMRM Model|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference from Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MMSE as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline MMSE, baseline MMSE by visit interaction, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||0.74|-0.35|0.4795
71006256|NCT02477800|141520831|SUPERIORITY||Difference from Placebo|-0.1||||0.8106|TWO_SIDED|95.0|-0.62|0.49|||MMRM Model|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference from Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MMSE as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline MMSE, baseline MMSE by visit interaction, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||0.49|-0.62|0.8106
71006257|NCT02477800|141520832|SUPERIORITY||Difference from Placebo|-0.583||||0.2536|TWO_SIDED|95.0|-1.5835|0.4181|||MMRM Model|||Adjusted mean for each treatment group (Placebo,BIIB037 Low Dose,BIIB037 High Dose),difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in ADAS-Cog 13 as dependent variable and with fixed effects of treatment group,categorical visit,treatment-by-visit interaction,baseline ADAS-Cog 13,baseline ADAS-Cog 13 by visit interaction,baseline MMSE,AD symptomatic medication use at baseline,region,and laboratory ApoE status.||0.4181|-1.5835|0.2536
71006258|NCT02477800|141520832|SUPERIORITY||Difference from Placebo|-0.588||||0.2578|TWO_SIDED|95.0|-1.6067|0.4309|||MMRM Model|||Adjusted mean for each treatment group (Placebo,BIIB037 Low Dose,BIIB037 High Dose),difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in ADAS-Cog 13 as dependent variable and with fixed effects of treatment group,categorical visit,treatment-by-visit interaction,baseline ADAS-Cog 13,baseline ADAS-Cog 13 by visit interaction,baseline MMSE,AD symptomatic medication use at baseline,region,and laboratory ApoE status.||0.4309|-1.6067|0.2578
71101902|NCT05339659|141711540|OTHER|The point null hypothesis of the significance test was a difference in expected number of log ins of 0.|Mean Difference (Final Values)|3.55||||0.219|TWO_SIDED|95.0|-2.33|9.44|||Regression, Linear||mean difference=experimental-control|A priori power calculations estimated detectable differences with 80% power with type 1 error rate=0.05, assuming a two-sided unequal variance t-test (standard deviations of 2.0 and 7.0 in the control and experimental arms, respectively) and a total sample of n=50 equally split between arms. Given a final sample size of 19 (7 control, 12 experimental), we re-calculated the detectable mean difference with these sample sizes (maintaining all other original assumptions), which is 6.51 sessions.||9.44|-2.33|0.219
71101903|NCT05339659|141711542|OTHER|The null hypothesis for the significance test is 0 difference in average number of days of use between arms.|Mean Difference (Final Values)|-22.12||||0.153|TWO_SIDED|95.0|-53.44|9.19|||Regression, Linear||mean difference=experimental-control|||9.19|-53.44|0.153
71101904|NCT05339659|141711543|OTHER|The null hypothesis for the significance test is a relative difference=0.|Risk Difference (RD)|0.095||||0.727|TWO_SIDED|95.0|-0.352|0.558|||Barnard's exact test||risk difference=experimental-control|||0.558|-0.352|0.727
71101905|NCT05339659|141711544|OTHER|The null hypothesis for the significance test is 0 difference in average score between arms.|Mean Difference (Final Values)|0.5||||0.325|TWO_SIDED|95.0|-0.6|1.61|||Regression, Linear||mean difference=experimental-control|||1.61|-0.60|0.325
70925366|NCT05071807|141344065|SUPERIORITY||Mean Difference (Net)|-1.65|||||TWO_SIDED|95.0|-4.25|0.95|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||0.95|-4.25|
70925367|NCT05071807|141344066|SUPERIORITY||Mean Difference (Net)|1.2|||||TWO_SIDED|95.0|-0.6|3.0|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||3.0|-0.6|
71008661|NCT02055976|141525238|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.6078|STANDARD_ERROR_OF_MEAN|2.3322||0.397|TWO_SIDED|95.0|-4.0274|5.2431|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||5.2431|-4.0274|0.397
71101906|NCT05339659|141711545|OTHER|The null hypothesis of the significance test is 0 difference in average score between arms.|Mean Difference (Final Values)|0.22||||0.745|TWO_SIDED|95.0|-1.28|1.72|||Regression, Linear||mean difference=experimental-control|||1.72|-1.28|0.745
71101907|NCT05339659|141711546|OTHER|The null hypothesis of the significance test is a risk difference=0.|Risk Difference (RD)|0.58||||0.009|TWO_SIDED|95.0|0.16|0.85|||Barnard's exact test||risk difference=experimental-control|||0.85|0.16|0.009
71006259|NCT02477800|141520833|SUPERIORITY||Difference from Placebo|0.7||||0.1225|TWO_SIDED|95.0|-0.19|1.64|||MMRM Model|||Adjusted mean for each group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference with Placebo,95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in ADCS-ADL-MCI as dependent variable and with fixed effects of treatment group,categorical visit,treatment-by-visit interaction, baseline ADCS-ADL-MCI, baseline ADCS-ADL-MCI by visit interaction, baseline MMSE AD symptomatic medication use at baseline,region, and laboratory ApoE status.||1.64|-0.19|0.1225
71006260|NCT02477800|141520833|SUPERIORITY||Difference from late start group|0.7||||0.1506|TWO_SIDED|95.0|-0.25|1.61|||MMRM Model|||Adjusted mean for each group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference with Placebo,95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in ADCS-ADL-MCI as dependent variable and with fixed effects of treatment group,categorical visit,treatment-by-visit interaction, baseline ADCS-ADL-MCI, baseline ADCS-ADL-MCI by visit interaction, baseline MMSE AD symptomatic medication use at baseline,region, and laboratory ApoE status.||1.61|-0.25|0.1506
71101908|NCT05339659|141711549|OTHER|The null hypothesis for the significance test is a mean difference of 0 cigarettes/day between arms.|Mean Difference (Final Values)|1.39||||0.469|TWO_SIDED|95.0|-2.66|5.44|||Regression, Linear|Adjusted for baseline cigarettes/day.|mean difference=experimental-control|||5.44|-2.66|0.469
71006261|NCT01948518|141520844|SUPERIORITY_OR_OTHER||||||=|0.3|TWO_SIDED||||||t-test, 2 sided|||Assuming 15% change in absolute value of DLCO representing a significant clinical difference and a standard deviation of 17.4% in normal nonsmoking individuals \[Miller A, Thornton JC, Warshaw R, et al. Am Rev Respir Dis. 1983;127 (suppl 3):270-277.\], 13 subjects needed to be studied to reject the null hypothesis when there is no significant difference between DLCO measurements before and after sildenafil, with power 0.8 and type I error probability 0.05 (SAS 9.2, SAS Institute Inc., Cary, NC)||||=0.30
71006262|NCT01948518|141520845|SUPERIORITY_OR_OTHER||||||=|0.63|||||||t-test, 2 sided|||The average 6 minute walk distance at baseline was 1195±407 feet. After oral administration of sildenafil, 6 minute walk distance was 1214±383 feet (p=0.63).||||=0.63
71006263|NCT00170846|141520846|SUPERIORITY_OR_OTHER||Difference in LS means|1.1241||||0.6332|TWO_SIDED|95.0|-3.5077|5.7559|||ANCOVA|||||5.7559|-3.5077|0.6332
71006264|NCT00170846|141520846|SUPERIORITY_OR_OTHER||Difference in LS means|0.5933||||0.7943|TWO_SIDED|95.0|-3.8815|5.0682|||ANCOVA|||||5.0682|-3.8815|0.7943
71006265|NCT01756833|141520855|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.035||0.71|TWO_SIDED|95.0|-0.07|0.07||Two prespecified interim analyses for efficacy performed when 1/3 \& 2/3 of primary outcome available, significance level, 1-sided, alpha=.0005. Final analysis 1-sided, alpha=.024. Futility analysis performed when \~2/3 primary outcome was available.|ANCOVA on normal scores|||"Null hypothesis: normal score of MTD at follow-up adjusted for baseline and gender in doxycycline assigned patients - normal score of MTD at follow-up adjusted for baseline and gender in placebo assigned patients = 0.~Sample size: The criterion (alpha) set for statistical significance was 1-sided .025; use of this level means that the inference from the test result will be the same as the inference from 2-sided testing at the .05 significance level."|For the primary analysis, diameters at baseline were ranked from smallest to largest (ranks 1-254). At the 2-year follow-up, ranks 1 through 225 were assigned to the diameters of surviving patients with no aneurysm repair (with missing values estimated by multiple imputation), ranks 226 through 247 were assigned to surviving patients who underwent aneurysm repair (in order of longest to shortest time from randomization to repair), and ranks 248 through 254 were assigned to patients who died (in order of longest to shortest time from randomization to death). Each rank was converted to a normal score corresponding to the value on the standard normal curve (z score) of its percentile among all 254 ranks. The primary analysis was based on linear regression of the change in normal scores from baseline to 2 years. Independent variables were baseline normal score, sex, and a dichotomous variable for the randomly assigned treatment group (0 for placebo, 1 for doxycycline).|0.07|-0.07|0.71
71006266|NCT04623255|141520863|SUPERIORITY|||||||0.16|||||||Chi-squared|||The primary analysis will involve a comparison of the binary outcome '50% reduction in at least two inflammation markers' between the PEX and Standard of Care (control) trial arms using a chi-squared test. The risk difference (and ratio) will be estimated with a 95% confidence interval.||||0.16
71006267|NCT04623255|141520864|SUPERIORITY|||||||0.606|TWO_SIDED|95.0|||||Chi-squared|||The primary analysis will involve a comparison of the binary outcome '50% reduction in inflammation marker CRP' between the PEX and Standard of Care (control) trial arms using a chi-squared test. The risk difference (and ratio) will be estimated with a 95% confidence interval.||||0.606
71006268|NCT04623255|141520865|SUPERIORITY|||||||0.245|||||||Chi-squared|||The primary analysis will involve a comparison of the binary outcome '50% reduction in inflammation marker D-Dimer' between the PEX and Standard of Care (control) trial arms using a chi-squared test. The risk difference (and ratio) will be estimated with a 95% confidence interval.||||0.245
71101909|NCT05339659|141711550|OTHER|The null hypothesis for the significance test is a mean difference of 0 cigarettes/day between arms.|Mean Difference (Final Values)|-0.66||||0.614|TWO_SIDED|95.0|-3.48|2.16|||Regression, Linear|Adjusted for baseline cigarettes/day.|mean difference=experimental-control|||2.16|-3.48|0.614
71101910|NCT05339659|141711551|OTHER|The null hypothesis for the significance test is 0 difference in average score between arms.|Mean Difference (Final Values)|-0.14||||0.9|TWO_SIDED|95.0|-2.67|2.38|||Regression, Linear||mean difference=experimental-control|||2.38|-2.67|0.90
71101911|NCT05339659|141711552|OTHER|The null hypothesis for the significance test is 0 difference in average score between arms.|Mean Difference (Final Values)|-0.55||||0.632|TWO_SIDED|95.0|-3.03|1.93|||Regression, Linear||mean difference=experimental-control|||1.93|-3.03|0.632
71101912|NCT05339659|141711553|OTHER|The null hypothesis for the significance test is 0 difference in average score between arms.|Mean Difference (Final Values)|-1.31||||0.227|TWO_SIDED|95.0|-3.55|-0.94|||Regression, Linear||mean difference=experimental-control|||-0.94|-3.55|0.227
71101913|NCT05339659|141711554|OTHER|The null hypothesis for the significance test is 0 difference in average score between arms.|Mean Difference (Final Values)|-1.22||||0.274|TWO_SIDED|95.0|-3.58|1.15|||Regression, Linear||mean difference=experimental-control|||1.15|-3.58|0.274
71101914|NCT05339659|141711558|OTHER|The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.|Risk Difference (RD)|0.04||||0.981|TWO_SIDED|95.0|-0.39|0.39|||Barnard's exact test||risk difference=experimental-control|||0.39|-0.39|0.981
71045018|NCT03575871|141599171|SUPERIORITY||Difference in LS mean|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.3|-1.1|||Mixed Models Analysis|||Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.1|-2.3|<0.0001
71045019|NCT03575871|141599171|SUPERIORITY||Difference in LS mean|-2.9|||<|0.0001|TWO_SIDED|95.0|-3.5|-2.3|||Mixed Models Analysis|||Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-2.3|-3.5|<0.0001
71045020|NCT03575871|141599171|SUPERIORITY||Difference in LS mean|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.3|||Mixed Models Analysis|||Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.3|-2.6|<0.0001
71045021|NCT03575871|141599171|SUPERIORITY||Difference in LS mean|-3.1|||<|0.0001|TWO_SIDED|95.0|-3.8|-2.5|||Mixed Models Analysis|||Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-2.5|-3.8|<0.0001
71045022|NCT03575871|141599171|SUPERIORITY||Difference in LS mean|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.3|-0.9|||Mixed Models Analysis|||Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-0.9|-2.3|<0.0001
71045023|NCT03575871|141599171|SUPERIORITY||Difference in LS mean|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.3|-1.9|||Mixed Models Analysis|||Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.9|-3.3|<0.0001
71045024|NCT03575871|141599171|SUPERIORITY||Difference in LS mean|-1.4||||0.0006|TWO_SIDED|95.0|-2.2|-0.6|||Mixed Models Analysis|||Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-0.6|-2.2|0.0006
71045025|NCT03575871|141599171|SUPERIORITY||Difference in LS mean|-2.2|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.4|||Mixed Models Analysis|||Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.4|-3.0|<0.0001
71045026|NCT03575871|141599172|SUPERIORITY||Difference in LS mean|-1.4|||<|0.0001|TWO_SIDED|95.0|-2.0|-0.8|||Mixed Models Analysis|||Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-0.8|-2.0|<0.0001
71045027|NCT03575871|141599172|SUPERIORITY||Difference in LS mean|-2.4|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.8|||Mixed Models Analysis|||Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.8|-3.0|<0.0001
71045028|NCT03575871|141599172|SUPERIORITY||Difference in LS mean|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.4|-1.2|||Mixed Models Analysis|||Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.2|-2.4|<0.0001
71045029|NCT03575871|141599172|SUPERIORITY||Difference in LS mean|-3.0|||<|0.0001|TWO_SIDED|95.0|-3.6|-2.3|||Mixed Models Analysis|||Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-2.3|-3.6|<0.0001
71045030|NCT03575871|141599172|SUPERIORITY||Difference in LS mean|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.3|-0.9|||Mixed Models Analysis|||Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-0.9|-2.3|<0.0001
71045031|NCT03575871|141599172|SUPERIORITY||Difference in LS mean|-2.4|||<|0.0001|TWO_SIDED|95.0|-3.1|-1.7|||Mixed Models Analysis|||Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.7|-3.1|<0.0001
71045032|NCT03575871|141599172|SUPERIORITY||Difference in LS mean|-0.9||||0.0164|TWO_SIDED|95.0|-1.7|-0.2|||Mixed Models Analysis|||Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-0.2|-1.7|0.0164
71045033|NCT03575871|141599172|SUPERIORITY||Difference in LS mean|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.0|||Mixed Models Analysis|||Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.0|-2.5|<0.0001
71045034|NCT03575871|141599173|SUPERIORITY||Difference in LS mean|-20.9|||<|0.0001|TWO_SIDED|95.0|-26.6|-15.1|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-15.1|-26.6|<0.0001
71045035|NCT03575871|141599173|SUPERIORITY||Difference in LS mean|-32.1|||<|0.0001|TWO_SIDED|95.0|-37.9|-26.4|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-26.4|-37.9|<0.0001
71045036|NCT03575871|141599173|SUPERIORITY||Difference in LS mean|-21.6|||<|0.0001|TWO_SIDED|95.0|-28.1|-15.2|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-15.2|-28.1|<0.0001
71045037|NCT03575871|141599173|SUPERIORITY||Difference in LS mean|-35.9|||<|0.0001|TWO_SIDED|95.0|-42.3|-29.4|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-29.4|-42.3|<0.0001
71045038|NCT03575871|141599173|SUPERIORITY||Difference in LS mean|-19.4|||<|0.0001|TWO_SIDED|95.0|-26.8|-12.1|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-12.1|-26.8|<0.0001
71045039|NCT03575871|141599173|SUPERIORITY||Difference in LS mean|-33.6|||<|0.0001|TWO_SIDED|95.0|-41.0|-26.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-26.3|-41.0|<0.0001
71045040|NCT03575871|141599173|SUPERIORITY||Difference in LS mean|-23.1|||<|0.0001|TWO_SIDED|95.0|-32.3|-13.9|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-13.9|-32.3|<0.0001
71045041|NCT03575871|141599173|SUPERIORITY||Difference in LS mean|-33.4|||<|0.0001|TWO_SIDED|95.0|-42.6|-24.3|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-24.3|-42.6|<0.0001
71045042|NCT00474851|141599174|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED|||||p (within group for subjects receiving norethindrone + conjugated estrogens)=0.05 p (within group for subjects receiving norethindrone + placebo)=0.65 p (between the two groups)=0.10|RMANOVA|||"Analysis followed the intention-to-treat principle. The time course of each measurement from baseline to 3, 6, 9, and 12 months was compared between arms by repeated-measures analysis of variance (RM-ANOVA), with an autoregressive covariance model to account for visit-to-visit correlation within subjects.~The primary test of treatment efficacy was time × treatment interaction. Adjusted changes over time and differences between trial arms were constructed from parameters of the RMANOVA."||||0.10
71045043|NCT00474851|141599175|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||p (within group for participants receiving norethindrone + estrogens)=0.0001 p (within group for participants receiving norethindrone + placebo)=0.31 p (between groups)=0.02|RMANOVA|||"The time course of each measurement from baseline to 3, 6, 9, and 12 months was compared between arms by repeated-measures analysis of variance (RM-ANOVA), with an autoregressive covariance model to account for visit-to-visit correlation within subjects.~The primary test of treatment efficacy was time × treatment interaction. Adjusted changes over time and differences between trial arms were constructed from parameters of the RMANOVA."||||0.02
71045044|NCT02791893|141599176|SUPERIORITY|||||||0.47||||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA|||A power analysis was conducted with G\*Power, specifying a standard Type I error (α = .05) and desired power of .80. Results indicated that a total sample of 26 would be sufficient. Below are the results of the intent-to-treat analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention pain severity was regressed on pre-intervention pain severity and condition, using an ANCOVA model.||||0.47
71045045|NCT02791893|141599176|SUPERIORITY|||||||0.58||||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA|||Below are the results of the per protocol analysis. Patients that did not complete the assessment after the blinded phase are not included limiting the sample to 10 subjects in each condition (N=20). Post-intervention pain severity was regressed on pre-intervention pain severity and condition, using an ANCOVA model.||||0.58
71045046|NCT02791893|141599177|SUPERIORITY|||||||0.23||||||The a priori threshold for statistical significance was p = 0.05.|t-test, 2 sided|This was an independent t-test comparing the conditions on their perception of change since starting the intervention.||"A power analysis was conducted with G\*Power, specifying a standard Type I error (α = .05) and desired power of .80. Results indicated that a total sample of 26 would be sufficient. Below are the results of the intent-to-treat analysis. Patients that did not complete the assessment after the blinded phase were assigned a score of 1 indicating no change in their condition. Post-intervention PGIC scores were compared between conditions."||||0.23
71045047|NCT02791893|141599177|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.23|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|t-test, 2 sided|This was an independent t-test comparing the conditions on their perception of change since starting the intervention.|Condition difference = Active - Sham|Below are the results of the per protocol analysis. Post-intervention PGIC scores were compared between conditions.||||0.23
71101915|NCT05339659|141711559|OTHER|The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.|Risk Difference (RD)|-0.01||||0.845|TWO_SIDED|95.0|-0.49|0.43|||Barnard's exact test||risk difference=experimental-control|||0.43|-0.49|0.845
71101916|NCT05339659|141711560|OTHER|The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.|Risk Difference (RD)|-0.05||||0.56|TWO_SIDED|95.0|-0.47|0.28|||Barnard's exact test||||risk difference=experimental-control|0.28|-0.47|0.560
71045048|NCT02791893|141599178|SUPERIORITY||Mean Difference (Final Values)|12.88||||0.13|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA||Condition difference = Active - Sham|A power analysis was conducted with G\*Power, specifying a standard Type I error (α = .05) and desired power of .80. Results indicated that a total sample of 26 would be sufficient. Below are the results of the intent-to-treat analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention physical function scores was regressed on pre-intervention physical function and condition, using an ANCOVA model.||||0.13
71045049|NCT02791893|141599178|SUPERIORITY||Mean Difference (Final Values)|10.5||||0.12|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA|||Below are the results of the per protocol analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention physical function scores was regressed on pre-intervention physical function and condition, using an ANCOVA model.||||0.12
71045050|NCT02791893|141599179|SUPERIORITY||Mean Difference (Final Values)|-5.71||||0.58|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA||Condition difference = Active - Sham|A power analysis was conducted with G\*Power, specifying a standard Type I error (α = .05) and desired power of .80. Results indicated that a total sample of 26 would be sufficient. Below are the results of the intent-to-treat analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention headache days was regressed on pre-intervention headache days and condition, using an ANCOVA model.||||0.58
71045051|NCT02791893|141599179|SUPERIORITY||Mean Difference (Final Values)|-9.8||||0.49|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA||Condition difference = Active - Sham|Below are the results of the per protocol analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention headache days was regressed on pre-intervention headache days and condition, using an ANCOVA model.||||0.49
71045052|NCT02791893|141599180|SUPERIORITY||Mean Difference (Final Values)|-1.42||||0.18|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA||Condition difference = Active - Sham|A power analysis was conducted with G\*Power, specifying a standard Type I error (α = .05) and desired power of .80. Results indicated that a total sample of 26 would be sufficient. Below are the results of the intent-to-treat analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention depression scores were regressed on pre-intervention depression scores and condition, using an ANCOVA model.||||0.18
71045053|NCT02791893|141599180|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.25|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA||Condition difference = Active - Sham|Below are the results of the per protocol analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention depression scores were regressed on pre-intervention depression scores and condition, using an ANCOVA model.||||0.25
71045054|NCT02791893|141599181|SUPERIORITY|||||||0.004||||||The a priori threshold for statistical significance was p = 0.05.|t-test, 2 sided|This was a dependent t-test comparing pre-intervention scores to the scores collected at the end of the open label phase.||Regardless of original condition assignment, patients' 2.5-month pain scores at the end of the open label phase were compared to their baseline scores using a dependent samples t-test. Below are the results of the intent-to-treat analysis. Patients that did not complete the assessment after the open-label phase had their most recent score carried forward. All patients included in this comparison received at least 10 weeks of VNS therapy.||||0.004
71045055|NCT02791893|141599181|SUPERIORITY|||||||0.005||||||This was a dependent t-test comparing baseline scores to the scores collected at the end of the open label phase.|t-test, 2 sided|||Regardless of original condition assignment, patients' 2.5-month pain scores at the end of the open label phase were compared to their baseline scores using a dependent samples t-test. Below are the results of the per protocol analysis. Patients that did not complete the assessment after the open-label phase were excluded. All patients included in this comparison received at least 10 weeks of VNS therapy.||||0.005
71045056|NCT01744093|141599190|OTHER|Descriptive proportion|Proportion (percent)|18.8|||||TWO_SIDED|95.0|4.0|45.6|||||Exact two-sided 95% Clopper-Pearson confidence interval.|||45.6|4.0|
71045057|NCT01744093|141599191|SUPERIORITY||Proportion (percent)|6.3||||0.002|TWO_SIDED|95.0|0.16|30.2|||Fisher Exact||Exact two-sided 95% Clopper-Pearson confidence interval.|Null hypothesis adverse event rate (grade 2 or higher toxicity) = 45.5%||30.2|0.16|0.002
71045058|NCT03998436|141599209|SUPERIORITY||Odds Ratio (OR)|2.126||||0.0276|TWO_SIDED|95.0|1.08|4.17|||Chi-squared|||||4.17|1.08|0.0276
71045059|NCT03998436|141599210|SUPERIORITY||Odds Ratio (OR)|2.708||||0.0126|TWO_SIDED|95.0|1.22|5.99|||Chi-squared|||||5.99|1.22|0.0126
71045060|NCT05212883|141599242|OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.8|1.3||||||Comparison of the likelihood to test before gathering for age \< 18 vs. age \>= 18.||1.3|0.8|
71045061|NCT03095118|141599263|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Proteinuria baseline values compared to 6 month follow up values||||0.001
71045062|NCT03095118|141599264|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||Proteinuria baseline values compared to 12 month follow up values||||0.004
71045063|NCT03095118|141599266|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||Serum creatinine baseline values compared to 6 month follow up values||||0.15
71045064|NCT03095118|141599267|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||Serum creatinine baseline values comparted to 12 month follow up values||||0.16
71101917|NCT05339659|141711561|OTHER|The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.|Risk Difference (RD)|0.04||||0.981|TWO_SIDED|95.0|-0.39|0.39|||Barnard's exact test||risk difference=experimental-control|||0.39|-0.39|0.981
71101918|NCT05339659|141711562|OTHER|The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.|Risk Difference (RD)|-0.13||||0.632|TWO_SIDED|95.0|-0.49|0.34|||Barnard's exact test||risk difference=experimental-control|||0.34|-0.49|0.632
71101919|NCT05339659|141711563|OTHER|The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.|Risk Difference (RD)|-0.03|||>|0.999|TWO_SIDED|95.0|-0.48|0.45|||Barnard's exact test||risk difference=experimental-control|||0.45|-0.48|>0.999
71045065|NCT03176784|141599288|SUPERIORITY||Odds Ratio (OR)|0.9||||0.66|TWO_SIDED|95.0|0.6|1.3|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.3|0.6|.66
70925368|NCT05071807|141344067|SUPERIORITY||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-2.3|1.6|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2).||||1.6|-2.3|
70925369|NCT05071807|141344068|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|0.0|0.1|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2).||||0.1|0.0|
71045066|NCT03176784|141599288|SUPERIORITY||Odds Ratio (OR)|1.0||||0.85|TWO_SIDED|95.0|0.7|1.4|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.4|0.7|.85
71045067|NCT03176784|141599288|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.7|1.4|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.4|0.7|1.00
71045068|NCT03176784|141599289|SUPERIORITY||Odds Ratio (OR)|1.2||||0.44|TWO_SIDED|95.0|0.8|1.7||Study site (Madison vs Milwaukee) was included as a covariate.|Regression, Logistic|||||1.7|0.8|.44
71045069|NCT03176784|141599289|SUPERIORITY||Odds Ratio (OR)|1.1||||0.61|TWO_SIDED|95.0|0.8|1.6|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.6|0.8|.61
71006269|NCT04623255|141520866|SUPERIORITY|||||||0.653|||||||Chi-squared|||The primary analysis will involve a comparison of the binary outcome '50% reduction in inflammation marker LDH' between the PEX and Standard of Care (control) trial arms using a chi-squared test. The risk difference (and ratio) will be estimated with a 95% confidence interval.||||0.653
71006270|NCT00998985|141520875|SUPERIORITY_OR_OTHER||Least Squares Mean (LSM) Difference|3.46|||||TWO_SIDED|90.0|2.89|4.03|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||4.03|2.89|
71006271|NCT00998985|141520875|SUPERIORITY_OR_OTHER||LSM Difference|4.68|||||TWO_SIDED|90.0|4.11|5.25|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||5.25|4.11|
71006272|NCT00998985|141520875|SUPERIORITY_OR_OTHER||LSM Difference|4.87|||||TWO_SIDED|90.0|4.3|5.44|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||5.44|4.30|
71045070|NCT03176784|141599289|SUPERIORITY||Odds Ratio (OR)|1.4||||0.12|TWO_SIDED|95.0|0.9|2.0|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||2.0|0.9|.12
71045071|NCT03176784|141599290|SUPERIORITY||Odds Ratio (OR)|0.8||||0.43|TWO_SIDED|95.0|0.5|1.3|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.3|0.5|.43
71045072|NCT03176784|141599290|SUPERIORITY||Odds Ratio (OR)|0.8||||0.37|TWO_SIDED|95.0|0.5|1.3|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.3|0.5|.37
71045073|NCT03176784|141599290|SUPERIORITY||Odds Ratio (OR)|1.1||||0.81|TWO_SIDED|95.0|0.7|1.6|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.6|0.7|.81
71045074|NCT03176784|141599291|SUPERIORITY||Odds Ratio (OR)|0.9||||0.65|TWO_SIDED|95.0|0.6|1.3|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.3|0.6|.65
71045075|NCT03176784|141599291|SUPERIORITY||Odds Ratio (OR)|0.9||||0.6|TWO_SIDED|95.0|0.6|1.3|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.3|0.6|.60
71045076|NCT03176784|141599291|SUPERIORITY||Odds Ratio (OR)|1.0||||0.86|TWO_SIDED|95.0|0.7|1.5|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.5|0.7|.86
71045077|NCT00904748|141599293|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Percent of reference to detect for 2-1 tests and power = 20.0%.|ratio between geometric means|98.68|||||TWO_SIDED|90.0|92.03|105.82|||ANOVA||Estimated value = ratio (% reference).|Ratio between geometric means of Test 1 study treatment (chewable without water) and reference study treatment (coated with water).||105.82|92.03|
71045078|NCT00904748|141599293|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Percent of reference to detect for 2-1 tests and power = 20.0%.|ratio between geometric means|97.23|||||TWO_SIDED|90.0|90.67|104.26|||ANOVA||Estimated value = ratio (% reference).|Ratio between geometric means of Test 2 study treatment (chewable with water) and reference study treatment (coated with water).||104.26|90.67|
71045079|NCT00904748|141599294|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Percent of reference to detect for 2-1 tests and power = 20%.|ratio between geometric means|80.83|||||TWO_SIDED|90.0|72.38|90.26|||ANOVA||Estimated value = ratio (% reference).|Ratio between geometric means of Test 1 study treatment (chewable without water) and reference study treatment (coated with water).||90.26|72.38|
71045080|NCT00904748|141599294|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Percent of reference to detect for 2-1 tests and power = 20%.|ratio between geometric means|78.76|||||TWO_SIDED|90.0|70.53|87.96|||ANOVA||Estimated value = ratio (% reference).|Ratio between geometric means of Test 2 study treatment (chewable with water) and reference study treatment (coated with water).||87.96|70.53|
71045081|NCT00904748|141599295|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Percent of reference to detect for 2-1 tests and power = 20.0%.|ratio between geometric means|99.12|||||TWO_SIDED|90.0|92.76|105.93|||ANOVA||Estimated value = ratio (% reference).|Ratio between geometric means of Test 1 study treatment (chewable without water) and reference study treatment (coated with water).||105.93|92.76|
71045082|NCT00904748|141599295|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Percent of reference to detect for 2-1 tests and power = 20.0%.|ratio between geometric means|97.84|||||TWO_SIDED|90.0|91.56|104.56|||ANOVA||Estimated value = ratio (% reference).|Ratio between geometric means of Test 2 study treatment (chewable with water) and reference study treatment (coated with water).||104.56|91.56|
71045083|NCT00904748|141599296|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|||||TWO_SIDED|90.0|-0.14|0.5|||ANOVA|||Difference in Tmax between Test 1 study treatment (chewable without water) and reference study treatment (coated with water).||0.50|-0.14|
71045084|NCT00904748|141599296|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|90.0|-0.27|0.28|||ANOVA|||Difference in Tmax between Test 2 study treatment (chewable with water) and reference study treatment (coated with water).||0.28|-0.27|
71045085|NCT02646917|141599303|SUPERIORITY||||||<|0.008|||||||Wilcoxon (Mann-Whitney)|||Goodman and Baron's qualitative acne scar severity scores. Calculated from Wilcoxon signed-rank test. Testing hypothesis is that the mean change from baseline is equal to zero.||||<0.008
71045086|NCT02646917|141599304|SUPERIORITY||||||<|0.001|||||||Wilcoxen signed-rank test|||Null hypothesis 4 (no change).||||<.001
71045087|NCT02646917|141599305|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Calculated from Wilcoxon signed-rank test. The testing hypothesis is that the mean change from baseline is equal to zero||||<0.01
71045088|NCT02646917|141599306|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Calculated from Wilcoxon signed-rank test. The testing hypothesis is that the mean score is equal to 0 (no change in the appearance of acne scars).||||<0.01
71045089|NCT02646917|141599307|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|Calculated from Wilcoxon signed-rank test. Testing hypothesis is that the mean score is equal to 4 (no change).||||||<0.01
71045090|NCT00680186|141599308|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin was set up to 2.75 for the HR analysis|Hazard Ratio (HR)|1.13||||0.0002||95.0|0.69|1.85||Non-inferiority P-Value.Two co-primary analyses performed on primary endpoint. Both non inferiority for the risk difference (RD) (at day 180) and for the HR (up to end of ptp) analyses to be reached in order to conclude positively on primary endpoint|Regression, Cox|Patients without events are censored at the end of ptp.||Hazard ratio (HR) vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the primary endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.85|0.69|0.0002
71045091|NCT00680186|141599308|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin was set up to 3.6% for the RD based on KM estimates|Risk Difference (Percentage)|0.2|||<|0.0001||95.0|-1.0|1.3||Non-inferiority P-Value.Two co-primary analyses performed on primary endpoint. Both non inferiority for the RD (at day 180) and for the HR (events up to end of ptp) analyses to be reached in order to conclude positively on the primary endpoint.|Kaplan Meier weighted estimates|||RD vs. Warfarin for Proportion of patients with VTE or death related to VTE at 6 months. Point estimate and 95% CI for the overall RD obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.3|-1.0|<0.0001
70925370|NCT05071807|141344069|SUPERIORITY||Mean Difference (Net)|9.4|||||TWO_SIDED|95.0|5.0|13.7||When a significant group by time point interaction was detected, post hoc testing was conducted and the Tukey-Kramer method was used to adjust for multiple comparisons.|Mixed Models Analysis|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2).||||13.7|5.0|
70925371|NCT05071807|141344070|SUPERIORITY||Median Difference (Net)|-8.1|||||TWO_SIDED|95.0|-14.5|-1.7|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||-1.7|-14.5|
71006273|NCT00998985|141520875|SUPERIORITY_OR_OTHER||LSM Difference|4.35|||||TWO_SIDED|90.0|3.78|4.92|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||4.92|3.78|
71006274|NCT00998985|141520875|SUPERIORITY_OR_OTHER||LSM Difference|5.15|||||TWO_SIDED|90.0|4.58|5.72|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||5.72|4.58|
71006275|NCT00998985|141520875|SUPERIORITY_OR_OTHER||LSM Difference|4.76|||||TWO_SIDED|90.0|4.19|5.33|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||5.33|4.19|
71006276|NCT00998985|141520875|SUPERIORITY_OR_OTHER||LSM Difference|4.93|||||TWO_SIDED|90.0|4.36|5.5|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||5.50|4.36|
71006277|NCT00998985|141520875|SUPERIORITY_OR_OTHER||LSM Difference|5.34|||||TWO_SIDED|90.0|4.93|5.74|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||5.74|4.93|
71006278|NCT00998985|141520876|SUPERIORITY_OR_OTHER||LSM Difference|2.25|||||TWO_SIDED|90.0|1.7|2.81|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10||2.81|1.70|
71006279|NCT00998985|141520876|SUPERIORITY_OR_OTHER||LSM Difference|2.94|||||TWO_SIDED|90.0|2.38|3.49|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10||3.49|2.38|
71006280|NCT00998985|141520876|SUPERIORITY_OR_OTHER||LSM Difference|3.84|||||TWO_SIDED|90.0|3.29|4.4|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10||4.40|3.29|
71006281|NCT00998985|141520876|SUPERIORITY_OR_OTHER||LSM difference|4.98|||||TWO_SIDED|90.0|4.42|5.53|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10||5.53|4.42|
71045092|NCT00680186|141599308|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||||95.0|0.64|1.8|||Regression, Cox|Patients without events are censored at the earliest of last contact date or day 180.||HR vs. Warfarin (events occurring between randomisation and day 180). The time to first occurrence of the primary endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE. This analysis was performed as sensitivity analysis for statistical analysis 1.||1.8|0.64|
70925372|NCT05071807|141344071|SUPERIORITY||Mean Difference (Net)|-25.5|||||TWO_SIDED|95.0|-98.6|47.5|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||Results for medium subclass; Measure Description: LDL particle size classifications are as follows: 22-25.5 nm is small, 25.6-26.5 nm medium, and 26.6-28.5 nm large. Typically, smaller LDL is associated with increased cardiovascular risk compared to larger.||47.5|-98.6|
71006282|NCT00998985|141520876|SUPERIORITY_OR_OTHER||LSM difference|4.21|||||TWO_SIDED|90.0|3.6|4.81|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10||4.81|3.60|
71045093|NCT00680186|141599309|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.3||||0.6932||95.0|-1.1|1.6|||Kaplan Meier weighted estimates|||RD vs. Warfarin for Proportion of patients with VTE or death at 6 months. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.6|-1.1|0.6932
71006283|NCT01040728|141520877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.197|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.163|0.231|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.231|0.163|<0.0001
71006284|NCT01040728|141520877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.221|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.186|0.255|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.255|0.186|<0.0001
71006285|NCT01040728|141520877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.221|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.187|0.255|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.255|0.187|<0.0001
71006286|NCT01040728|141520878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.153|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.117|0.188|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.188|0.117|<0.0001
70925373|NCT05071807|141344071|SUPERIORITY||Mean Difference (Net)|1.86|||||TWO_SIDED|95.0|-91.8|95.5|||Regression, Linear|adjustment for the baseline value, age (years), sex (male or female) and body mass index (BMI) (kg/m2)||Results for Small LDL particles; Measure Description: LDL particle size classifications are as follows: 22-25.5 nm is small, 25.6-26.5 nm medium, and 26.6-28.5 nm large. Typically, smaller LDL is associated with increased cardiovascular risk compared to larger.||95.5|-91.8|
70925374|NCT05071807|141344072|SUPERIORITY||Mean Difference (Net)|0.35|||||TWO_SIDED|95.0|0.07|0.63|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2).||||0.63|0.07|
71045094|NCT00680186|141599309|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.6383||95.0|0.75|1.6|||Regression, Cox|Patients without events are censored at the end of ptp.||HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.60|0.75|0.6383
71045095|NCT00680186|141599310|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.6||||0.1703||95.0|-0.3|1.5|||Kaplan Meier weighted estimates|||RD vs. Warfarin for Proportion of patients with symptomatic DVT at 6 months. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.5|-0.3|0.1703
70925375|NCT04072380|141344081|SUPERIORITY|||||||0.024||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Mixed model for repeated measures (MMRM)||||||0.024
70925376|NCT04072380|141344082|SUPERIORITY|||||||0.009||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Mixed model for repeated measures (MMRM)||||||0.009
71006287|NCT01040728|141520878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.134|0.205|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.205|0.134|<0.0001
71006288|NCT01040728|141520878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.128|0.199|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.199|0.128|<0.0001
71006289|NCT01040728|141520879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.141|0.208|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.208|0.141|<0.0001
71006290|NCT01040728|141520879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.191|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.157|0.225|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.225|0.157|<0.0001
71006291|NCT01040728|141520879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.159|0.226|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.226|0.159|<0.0001
71006292|NCT01040728|141520880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.214|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.181|0.248|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.248|0.181|<0.0001
71006293|NCT01040728|141520880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.205|0.272|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.272|0.205|<0.0001
71006294|NCT01040728|141520880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.119|0.185|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.185|0.119|<0.0001
71006295|NCT01040728|141520881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.214|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.178|0.251|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.251|0.178|<0.0001
71006296|NCT01040728|141520881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.245|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.208|0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.282|0.208|<0.0001
71006297|NCT01040728|141520881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.235|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.199|0.271|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.271|0.199|<0.0001
71006298|NCT01040728|141520882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.237|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.201|0.273|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.273|0.201|<0.0001
71006299|NCT01040728|141520882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.266|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.23|0.302|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.302|0.230|<0.0001
71006300|NCT01040728|141520882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.138|0.211|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.211|0.138|<0.0001
70925377|NCT04072380|141344083|SUPERIORITY|||||||0.734||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Mixed model for repeated measures (MMRM)||||||0.734
70925378|NCT04072380|141344084|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70925379|NCT04072380|141344085|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
70925380|NCT05521308|141344139|SUPERIORITY||Mean Difference (Final Values)|0.38|||<|0.001|TWO_SIDED|95.0|0.2|1.0|||ANOVA|||This is to see if there is a difference in preference count per participant between Variation #1, Variation #2 and Same counts.||1.00|0.20|<0.001
70925381|NCT05521308|141344139|SUPERIORITY||Mean Difference (Final Values)|3.23||||0.02|TWO_SIDED|95.0|0.41|6.05|||t-test, 2 sided|||This is to see if there is a difference between Variation #1 and Variation #2 preference counts per participant.||6.05|0.41|0.02
70925382|NCT05521308|141344139|SUPERIORITY||Mean Difference (Final Values)|0.35|||<|0.001|TWO_SIDED|95.0|0.18|1.0|||ANOVA|||This is to see if there is a difference in preference count per participant between Variation #1, Variation #3 and Same counts.||1.00|0.18|<0.001
70925383|NCT05521308|141344139|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.54|TWO_SIDED|95.0|-1.36|3.55|||t-test, 2 sided|||This is to see if there is a difference between Variation #1 and Variation #3 preference counts per participant.||3.55|-1.36|.54
70925384|NCT05521308|141344139|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.231|TWO_SIDED|95.0|0.0|1.0|||ANOVA|||This is to see if there is a difference in preference count per participant between Variation #2, Variation #3, and Same counts.||1.00|0|.231
70925385|NCT05521308|141344141|SUPERIORITY||Cramer's V|0.14||||0.13|TWO_SIDED||||||Chi-squared|This is to see if there is a difference in preference counts between standard curve, variation #4, and # of times they were rated as the same. -Indoor||||||.13
71045096|NCT00680186|141599310|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.65||||0.1054||95.0|0.9|3.01|||Regression, Cox|Patients without events are censored at the end of ptp.||HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||3.01|0.90|0.1054
71045097|NCT00680186|141599311|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.4||||0.2283||95.0|-1.1|0.3|||Kaplan Meier weighted estimates|||RD vs. Warfarin for Proportion of patients with symptomatic non-fatal PE at 6 months. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||0.3|-1.1|0.2283
70925386|NCT05521308|141344141|SUPERIORITY||Cramer's V|0.2||||0.04|TWO_SIDED|||||This is to see if there is a difference in preference counts between standard curve, variation #4, and # of time they were rated as the same. -Outdoor|Chi-squared|||||||0.04
70925387|NCT05521308|141344141|SUPERIORITY||Cramer's V|0.2||||0.04|TWO_SIDED||||||Chi-squared|||The number of participants that showed overall preference toward variation #4 vs. the standard curve vs. no preference. - Outdoors.||||0.04
70925388|NCT05521308|141344142|SUPERIORITY||Effect Size|0.26|||<|0.001|TWO_SIDED|95.0|0.1|1.0|||ANOVA|Initally this is to see if there is a differnce between Unaided, Aided #1 and Aided #2.||Standard Curve vs Variation #4||1.00|0.10|<0.001
70925389|NCT05521308|141344142|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.855|TWO_SIDED|95.0|-2.83|2.35||Post-Hoc Pairwise Comparison|t-test, 2 sided|Standard Curve vs Variation #4||||2.35|-2.83|0.855
70925390|NCT04760678|141344176|OTHER|Fisher's exact test||||||0.107|||||||Fisher Exact|||||||0.107
70925391|NCT01748448|141344200|SUPERIORITY||Cox Proportional Hazard|1.27|||=|0.324|TWO_SIDED|95.0|0.79|2.03|||Fisher Exact|||||2.03|0.79|= 0.324
70925392|NCT01926496|141344214|SUPERIORITY||Risk Ratio (RR)|0.89||||0.03|TWO_SIDED|95.0|0.8|0.99|||Cochran-Mantel-Haenszel|Stratified by country, anatomical location and history of squamous cell carcinoma.|Cochran-Mantel-Haenszel relative risk (ingenol mebutate / imiquimod), stratified by country, anatomical location and history of squamous cell carcinoma.|||0.99|0.80|0.03
70925393|NCT01926496|141344215|SUPERIORITY||Risk Ratio (RR)|0.95||||0.18|TWO_SIDED|95.0|0.87|1.03|||Cochran-Mantel-Haenszel|Stratified by country, anatomical location and history of squamous cell carcinoma.|Cochran-Mantel-Haenszel relative risk (ingenol mebutate / imiquimod), stratified by country, anatomical location and history of squamous cell carcinoma.|||1.03|0.87|0.18
70925394|NCT01926496|141344216|SUPERIORITY||Risk Ratio (RR)|0.66|||<|0.001|TWO_SIDED|95.0|0.52|0.84|||Cochran-Mantel-Haenszel|Stratified by country, anatomical location and history of squamous cell carcinoma.|Cochran-Mantel-Haenszel relative risk (ingenol mebutate / imiquimod), stratified by country, anatomical location and history of squamous cell carcinoma.|||0.84|0.52|<0.001
70925395|NCT03232138|141344224|EQUIVALENCE|2-sided P-value in the analysis|Mean Difference (Final Values)|0.22||||0.452|TWO_SIDED|95.0|0.03|0.41||Hypothesis: sulforaphane treatment slows or reverse the progression of lung histological lesions or lower the dysplasia score.|ANCOVA|ANCOVA model includes baseline average endobronchial histopathological scores,age,sex,cigarettes per day,years of smoking, years since quit smoking.||Derived from ANCOVA model with adjustment for baseline average endobronchial histopathological scores, age, sex, cigarettes per day, years of smoking, and years since quit smoking.||0.41|0.03|0.452
70925396|NCT03232138|141344224|EQUIVALENCE|2-sided P-value in the analysis|Mean Difference (Final Values)|0.12||||0.452|TWO_SIDED|95.0|-0.04|0.28||Hypothesis: sulforaphane treatment slows or reverse the progression of lung histological lesions or lower the dysplasia score.|ANCOVA|ANCOVA model includes baseline average endobronchial histopathological scores,age,sex,cigarettes per day,years of smoking, years since quit smoking||Derived from ANCOVA model with adjustment for baseline average endobronchial histopathological scores, age, sex, cigarettes per day, years of smoking, and years since quit smoking.||0.28|-0.04|0.452
71006301|NCT01040728|141520883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.208|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.169|0.246|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.246|0.169|<0.0001
71006302|NCT01040728|141520883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.243|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.205|0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.282|0.205|<0.0001
71045098|NCT00680186|141599311|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59||||0.2101||95.0|0.26|1.35|||Regression, Cox|||HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.35|0.26|0.2101
71006303|NCT01040728|141520883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.244|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.205|0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.282|0.205|<0.0001
71006304|NCT01040728|141520884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.097|0.171|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.171|0.097|<0.0001
71006305|NCT01040728|141520884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.105|0.181|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.181|0.105|<0.0001
71006306|NCT01040728|141520884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.12|0.195|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.195|0.120|<0.0001
71006307|NCT01040728|141520885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.276|0.384|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.384|0.276|<0.0001
71006308|NCT01040728|141520885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.326|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.272|0.381|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.381|0.272|<0.0001
71006309|NCT01040728|141520885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.316|0.424|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.424|0.316|<0.0001
71006310|NCT01040728|141520886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.214|0.342|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.342|0.214|<0.0001
71006311|NCT01040728|141520886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.264|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.2|0.329|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.329|0.200|<0.0001
71006312|NCT01040728|141520886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.302|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.238|0.366|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.366|0.238|<0.0001
71006313|NCT01040728|141520887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.304|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.244|0.363|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.363|0.244|<0.0001
71045099|NCT00680186|141599312|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.2||||0.083||95.0|0.0|0.5|||Kaplan Meier weighted estimates|||RD at 6 months vs. Warfarin for Proportion of patients who died due to VTE . Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||0.5|0.0|0.0830
71045100|NCT00680186|141599313|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.1||||0.7348||95.0|-0.7|1.0|||Kaplan Meier weighted estimates|||RD at 6 months vs. Warfarin for Proportion of patients who died from any cause. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.0|-0.7|0.7348
71006314|NCT01040728|141520887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.283|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.222|0.343|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.343|0.222|<0.0001
71006315|NCT01040728|141520887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.335|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.275|0.395|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.395|0.275|<0.0001
71006316|NCT01040728|141520888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.309|0.43|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.430|0.309|<0.0001
71006317|NCT01040728|141520888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.366|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.306|0.426|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.426|0.306|<0.0001
71006318|NCT01040728|141520888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.262|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.202|0.322|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.322|0.202|<0.0001
71006319|NCT01040728|141520889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.344|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.287|0.401|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.401|0.287|<0.0001
71006320|NCT01040728|141520889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.353|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.296|0.411|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.411|0.296|<0.0001
70925397|NCT03232138|141344225|EQUIVALENCE|2-sided P-value in the analysis||||||0.738||||||Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo.|Analysis of Covariance|||All positive nuclei. Mean (95%CI) changes in baseline.||||0.738
70925398|NCT03232138|141344225|EQUIVALENCE|2-sided P-value in the analysis||||||0.78||||||Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo.|Analysis of Covariance|||Weak-intensity positive nuclei. Mean (95%CI) baseline.||||0.780
70925399|NCT03232138|141344225|EQUIVALENCE|2-sided P-value in the analysis||||||0.733||||||Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo.|Analysis of Covariance|||Moderate intensity positive nuclei. Mean (95%CI) changes in baseline.||||0.733
70925400|NCT03232138|141344225|EQUIVALENCE|2-sided P-value in the analysis||||||0.751||||||Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo.|Analysis of Covariance|||Strong-Intensity positive nuclei. Mean (95%CI) changes in baseline.||||0.751
71006321|NCT01040728|141520889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.314|0.427|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.427|0.314|<0.0001
71006322|NCT01040728|141520890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.334|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.272|0.396|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.396|0.272|<0.0001
71006323|NCT01040728|141520890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.346|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.283|0.408|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.408|0.283|<0.0001
71006324|NCT01040728|141520890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.378|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.316|0.44|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.440|0.316|<0.0001
71006325|NCT01040728|141520891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.244|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.179|0.309|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.309|0.179|<0.0001
71006326|NCT01040728|141520891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.216|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.15|0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.282|0.150|<0.0001
70925401|NCT03232138|141344225|EQUIVALENCE|2-sided P-value in the analysis||||||0.014||||||Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo.|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of Ki-67 positive nuclei||All positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.014
71006327|NCT01040728|141520891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.256|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.191|0.321|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.321|0.191|<0.0001
70925402|NCT03232138|141344225|EQUIVALENCE|2-sided P-value in the analysis||||||0.056|||||||Covariance|Analysis of Covariance adjustment age, sex, cigarettes/day, years of smoking, years of quit smoking,baseline values of the same cellular biomarker||Week intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.056
70925403|NCT03232138|141344225|EQUIVALENCE|2-sided P-value in the analysis||||||0.028|||||||Analysis of Covariance|Analysis of Covariance adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking,baseline values of the same cellular biomarker||Moderate Intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.028
70925404|NCT03232138|141344225|EQUIVALENCE|2-sided P-value in the analysis||||||0.004|||||||Analysis of Covariance|Analysis of Covariance adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking,baseline values of the same cellular biomarker||Strong intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.004
71006328|NCT01601873|141520907|SUPERIORITY|||||||0.884|||||||Wilcoxon (Mann-Whitney)|||||||0.884
71006329|NCT01601873|141520908|SUPERIORITY|||||||0.946|||||||Wilcoxon (Mann-Whitney)|||||||0.946
71006330|NCT01601873|141520909|SUPERIORITY|||||||0.294|||||||Wilcoxon (Mann-Whitney)|||||||0.294
71006331|NCT01601873|141520910|SUPERIORITY|||||||0.538|||||||Log Rank|||||||0.538
71006332|NCT01601873|141520911|SUPERIORITY|||||||0.786|||||||Log Rank|||||||0.786
71006333|NCT01601873|141520912|SUPERIORITY|||||||0.185|||||||Log Rank|||||||0.185
71006334|NCT02176005|141520926|OTHER||Contrast (B/A)|0.0093|||<|1e-06|TWO_SIDED|95.0|0.006|0.0144|||General linear model|||||0.0144|0.0060|<.000001
71006335|NCT02176005|141520927|OTHER||Contrast (B/A)|0.0096|||<|1e-06|TWO_SIDED|95.0|0.0061|0.0151|||General linear model|||||0.0151|0.0061|<.000001
71006336|NCT02176005|141520928|OTHER||Contrast (B/A)|0.9811||||0.806|TWO_SIDED|95.0|0.8608|1.1182|||General linear model|||||1.1182|0.8608|0.806
71006337|NCT02176005|141520929|OTHER||Contrast (B/A)|0.8785||||0.139|TWO_SIDED|95.0|0.76|1.0155|||General linear model|||||1.0155|0.7600|0.139
71006338|NCT02176005|141520930|OTHER||Contrast (B/A)|1.1763||||0.104|TWO_SIDED|95.0|0.9982|1.3861|||General linear model|||||1.3861|0.9982|0.104
71006339|NCT02176005|141520931|OTHER||Contrast (B/A)|0.9391||||0.519|TWO_SIDED|95.0|0.7969|1.1066|||General linear model|||||1.1066|0.7969|0.519
71006340|NCT02871570|141520943|OTHER||ratio|0.7789|||||TWO_SIDED|90.0|0.6514|0.9313|||||Moderate hepatic impairment group represents the numerator, and normal hepatic function group represents the denominator.|||0.9313|0.6514|
70925405|NCT03232138|141344226|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) at baseline for positive cells. TUNEL positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.377||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies compared with the place|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||All positive nuclei. Mean (95%CI) baseline.||||0.377
70925406|NCT03232138|141344226|EQUIVALENCE|2-sided P-value in the analysis||||||0.413||||||Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo.|Analysis of Covariance|||Weak-intensity positive nuclei. Mean (95%CI) baseline.||||0.413
70925407|NCT03232138|141344226|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) at baseline Moderate-intensity positive nuclei. TUNEL positive (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.338||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies compared with the place|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||Moderate Intensity positive nuclei. Mean (95%CI) at baseline.||||0.338
70925408|NCT03232138|141344226|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) at baseline for positive cells. TUNEL positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.547||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||Strong-intensity positive nuclei. Mean (95%CI) baseline.||||0.547
70925409|NCT03232138|141344226|EQUIVALENCE|used 2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for all positive cells. TUNEL all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.291||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||All positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.291
71006341|NCT02871570|141520944|OTHER||ratio|0.7776|||||TWO_SIDED|90.0|0.6493|0.9311|||||Moderate hepatic impairment group represents the numerator, and normal hepatic function group represents the denominator.|||0.9311|0.6493|
71006342|NCT02871570|141520945|OTHER||ratio|1.2844|||||TWO_SIDED|90.0|1.0732|1.5372|||||Moderate hepatic impairment group represents the numerator, and normal hepatic function group represents the denominator.|||1.5372|1.0732|
71006343|NCT02871570|141520946|OTHER||ratio|0.7945|||||TWO_SIDED|90.0|0.5955|1.0599|||||Moderate hepatic impairment group represents the numerator, and normal hepatic function group represents the denominator.|||1.0599|0.5955|
71006344|NCT02545049|141520982|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.0264|TWO_SIDED|95.0|0.76|0.98||A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||0.98|0.76|0.0264
71006345|NCT02545049|141520983|SUPERIORITY|If the treatment effect of the 40% renal composite endpoint was not significant, all other endpoints (i.e. all-cause hospitalization, all-cause mortality, change in UACR from baseline to Month 4, and 57% renal composite endpoint) would be tested in an exploratory manner.|Hazard Ratio (HR)|0.87||||0.0689|TWO_SIDED|95.0|0.76|1.01||A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||1.01|0.76|0.0689
71008662|NCT02055976|141525238|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.7096|STANDARD_ERROR_OF_MEAN|2.3367||0.008|TWO_SIDED|95.0|1.0659|10.3532|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.3532|1.0659|0.008
71008663|NCT02055976|141525238|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.4558|STANDARD_ERROR_OF_MEAN|2.323||0.147|TWO_SIDED|95.0|-2.1608|7.0724|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.0724|-2.1608|0.147
71008664|NCT02055976|141525240|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.9203|STANDARD_ERROR_OF_MEAN|1.3242|<|0.001|TWO_SIDED|95.0|-7.5504|-2.2901|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-2.2901|-7.5504|<0.001
71008665|NCT02055976|141525240|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.1983|STANDARD_ERROR_OF_MEAN|1.3462|<|0.001|TWO_SIDED|95.0|-9.8718|-4.5249|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-4.5249|-9.8718|<0.001
71008666|NCT02055976|141525240|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.3118|STANDARD_ERROR_OF_MEAN|1.3505|<|0.001|TWO_SIDED|95.0|-9.9935|-4.6301|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-4.6301|-9.9935|<0.001
71045101|NCT00680186|141599313|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.8939||95.0|0.61|1.77|||Regression, Cox|Patients without events are censored at the end of ptp.||HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.77|0.61|0.8939
71045102|NCT00680186|141599314|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.3||||0.321|TWO_SIDED|95.0|-1.0|0.3|||Kaplan Meier weighted estimates|||RD vs. Warfarin for Proportion of patients with symptomatic fatal and non-fatal PE at 6 months. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||0.3|-1.0|0.3210
71045103|NCT00680186|141599314|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.3021|TWO_SIDED|95.0|0.29|1.46|||Regression, Cox|||HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.46|0.29|0.3021
71045104|NCT00680186|141599315|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||||95.0|0.36|1.32|||Regression, Cox||This is the analysis of the time to the first MBE.|HR vs. Warfarin (events occurring between 1st intake of study drug and last intake of study drug + 6 days). The time to first occurrence of MBE was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.32|0.36|
71045105|NCT00680186|141599315|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67|||<|0.0001|TWO_SIDED|95.0|0.56|0.81|||Regression, Cox||This is the analysis of the time to the first occurrence of any bleeding event.|HR vs. Warfarin (events occurring between 1st intake of study drug and last intake of study drug + 6 days). The time to first occurrence of any bleeding was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||0.81|0.56|<0.0001
71045106|NCT00285584|141599323|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.5||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.9
71045107|NCT00285584|141599324|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.5||||0.3|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank test||||0.3
71045108|NCT00285584|141599325|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.15||||0.3|TWO_SIDED|95.0|0.4|27.8|||Fisher Exact|||Comparison of cumulative incidence proportions||27.8|0.4|0.3
71045109|NCT00285584|141599326|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.5||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
71045110|NCT00645944|141599327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8||||0.039|TWO_SIDED|95.0|-7.5|-0.2|||Mixed Models Analysis|||||-0.2|-7.5|0.039
71045111|NCT01523587|141599329|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.814||||0.0103|TWO_SIDED|95.0|0.693|0.956||P-value from log-rank stratified by Race (two-sided). Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazards model stratified by Race.|Log Rank|||A Cox proportional hazards model without the randomization stratification variable was used for each subgroup category, along with the corresponding log-rank test.||0.956|0.693|0.0103
71045112|NCT01523587|141599330|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.841||||0.0193|TWO_SIDED|95.0|0.727|0.973||P-value from log-rank stratified by Race (two-sided). Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazards model stratified by Race.|Log Rank|||A Cox proportional-hazards model, stratified by race, was used to estimate the hazard ratio and 95% confidence interval (CI) between the two treatment groups.||0.973|0.727|0.0193
71045113|NCT01523587|141599331|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06||||0.0551|TWO_SIDED|95.0|0.98|4.32||Odds ratio (Afatinib vs Erlotinib), 95% CI and p-value (two-sided) from logistic regression stratified by race.|Regression, Logistic|||||4.32|0.98|0.0551
71045114|NCT01523587|141599332|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.002|TWO_SIDED|95.0|1.18|2.06|||Regression, Logistic|Odds ratio (Afatinib vs Erlotinib), 95% CI and p-value (two-sided) from logistic regression stratified by race.||||2.06|1.18|0.0020
71045115|NCT01523587|141599333|SUPERIORITY_OR_OTHER||Adjusted mean|-1.2|STANDARD_ERROR_OF_MEAN|1.77||0.5|TWO_SIDED|95.0|-4.67|2.28|||ANCOVA||Mean was adjusted for baseline sum of diameters and race.|The analysis will compare the treatments using analysis of covariance (ANCOVA) for minimum sum of diameters, using baseline sum of diameters as a covariate. The randomization strata will be included as classification factors.||2.28|-4.67|0.500
71045116|NCT01523587|141599335|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.2562|TWO_SIDED|95.0|0.72|1.09||p-value calculated using log rank test stratified by race.|Regression, Cox||Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazard model stratified by race.|The results shown relate to Time to Deterioration in Coughing.||1.09|0.72|0.2562
71045117|NCT01523587|141599335|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0078|TWO_SIDED|95.0|0.66|0.94||p-value calculated using log rank test stratified by race.|Regression, Cox||Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazard model stratified by race.|The results shown relate to Time to Deterioration in Dyspnoea||0.94|0.66|0.0078
71045118|NCT01523587|141599335|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.869|TWO_SIDED|95.0|0.82|1.18||p-value calculated using log rank test stratified by race|Regression, Cox||Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazard model stratified by race.|The results shown relate to Time to Deterioration in Pain||1.18|0.82|0.8690
71045119|NCT01523587|141599336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|1.34||0.0091|TWO_SIDED|95.0|-6.15|-0.88|||Regression, Cox|||The results shown relate to Change in scores over time for: Coughing.||-0.88|-6.15|0.0091
71045120|NCT01523587|141599336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|1.15||0.0024|TWO_SIDED|95.0|-5.75|-1.25|||Regression, Cox|||The results shown relate to Change in scores over time for: Dyspnoea.||-1.25|-5.75|0.0024
71045121|NCT01523587|141599336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|1.32||0.0384|TWO_SIDED|95.0|-5.33|-0.15|||Regression, Cox|||The results shown relate to Change in scores over time for: Pain.||-0.15|-5.33|0.0384
71045122|NCT01298778|141599337|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||acute pain scores with movement at 24 hours||||0.05
71045123|NCT02709486|141599370|SUPERIORITY|Step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.18||0.0088|TWO_SIDED|95.0|-0.81|-0.12||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. Analysis of covariance (ANCOVA) model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.12|-0.81|0.0088
71045124|NCT02709486|141599370|SUPERIORITY|A step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. A tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.18||0.0006|TWO_SIDED|95.0|-0.97|-0.26||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.26|-0.97|0.0006
71045125|NCT02709486|141599371|SUPERIORITY|Step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.18||0.0008|TWO_SIDED|95.0|-0.93|-0.24||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.24|-0.93|0.0008
71045126|NCT02709486|141599371|SUPERIORITY|Step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.05|-0.36||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.36|-1.05|<.0001
71045127|NCT02709486|141599372|SUPERIORITY|A step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. A tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.1092|TWO_SIDED|95.0|-0.24|0.02||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||0.02|-0.24|0.1092
71045128|NCT02709486|141599372|SUPERIORITY|A step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. A tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.07||0.0051|TWO_SIDED|95.0|-0.32|-0.06||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.06|-0.32|0.0051
71045129|NCT02709486|141599373|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.94|-0.4|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.40|-0.94|<.0001
71006346|NCT02545049|141520984|SUPERIORITY|If the treatment effect of the 40% renal composite endpoint was not significant, all other endpoints (i.e. all-cause hospitalization, all-cause mortality, change in UACR from baseline to Month 4, and 57% renal composite endpoint) would be tested in an exploratory manner.|Hazard Ratio (HR)|0.97||||0.3558|TWO_SIDED|95.0|0.9|1.04||A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||1.04|0.90|0.3558
71006347|NCT02545049|141520985|SUPERIORITY|If the treatment effect of the 40% renal composite endpoint was not significant, all other endpoints (i.e. all-cause hospitalization, all-cause mortality, change in UACR from baseline to Month 4, and 57% renal composite endpoint) would be tested in an exploratory manner.|Hazard Ratio (HR)|0.89||||0.1337|TWO_SIDED|95.0|0.77|1.04||A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||1.04|0.77|0.1337
71006348|NCT02545049|141520986|SUPERIORITY|If the treatment effect of the 40% renal composite endpoint was not significant, all other endpoints (i.e. all-cause hospitalization, all-cause mortality, change in UACR from baseline to Month 4, and 57% renal composite endpoint) would be tested in an exploratory manner.|Ratio of least squares means|0.676|||<|0.0001|TWO_SIDED|95.0|0.65|0.704||P-value from F-test of equal means between the treatment groups. A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.|ANCOVA|||||0.704|0.650|<0.0001
71006349|NCT02545049|141520987|SUPERIORITY|If the treatment effect of the 40% renal composite endpoint was not significant, all other endpoints (i.e. all-cause hospitalization, all-cause mortality, change in UACR from baseline to Month 4, and 57% renal composite endpoint) would be tested in an exploratory manner.|Hazard Ratio (HR)|0.77||||0.0406|TWO_SIDED|95.0|0.6|0.99||A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||0.99|0.60|0.0406
71006350|NCT01855919|141520988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0026|TWO_SIDED|95.0|-0.77|-0.16|||Mixed Models Analysis|||||-0.16|-0.77|0.0026
71006351|NCT01855919|141520989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.0026|TWO_SIDED|95.0|-0.48|-0.1|||Mixed Models Analysis|||||-0.10|-0.48|0.0026
71006352|NCT01855919|141520990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.0439|TWO_SIDED|95.0|-1.25|-0.02|||ANCOVA|||||-0.02|-1.25|0.0439
71006353|NCT01855919|141520991|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.3||||0.101|TWO_SIDED|95.0|-0.66|0.06||p-value is for worst pain|Mixed Models Analysis|||||0.06|-0.66|0.1010
71006354|NCT01855919|141520991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0009|TWO_SIDED|95.0|-0.79|-0.21||p-value is for least pain|Mixed Models Analysis|||||-0.21|-0.79|0.0009
71006355|NCT01855919|141520991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.023|TWO_SIDED|95.0|-0.74|-0.05||p-value is for Pain Right Now|Mixed Models Analysis|||||-0.05|-0.74|0.0230
71006356|NCT01855919|141520991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.0874|TWO_SIDED|95.0|-0.66|0.05||p-value is for General Activity|Mixed Models Analysis|||||0.05|-0.66|0.0874
71006357|NCT01855919|141520991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.0436|TWO_SIDED|95.0|-0.63|-0.01||p-value is for Mood|Mixed Models Analysis|||||-0.01|-0.63|0.0436
71006358|NCT01855919|141520991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.3902|TWO_SIDED|95.0|-0.45|0.18||p-value is for Walking Ability|Mixed Models Analysis|||||0.18|-0.45|0.3902
71006359|NCT01855919|141520991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.991|TWO_SIDED|95.0|-0.33|0.33||p-value is for Normal Work|Mixed Models Analysis|||||0.33|-0.33|0.9910
71045130|NCT02709486|141599373|SUPERIORITY||Least Square Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.14||0.0149|TWO_SIDED|95.0|-0.61|-0.07|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.07|-0.61|0.0149
71045131|NCT02709486|141599373|SUPERIORITY||Least Square Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.08|-0.5|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.50|-1.08|<.0001
71006360|NCT01855919|141520991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.7848|TWO_SIDED|95.0|-0.3|0.23||p-value is for Relationship People|Mixed Models Analysis|||||0.23|-0.30|0.7848
71006361|NCT01855919|141520991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9424|TWO_SIDED|95.0|-0.32|0.3||p-value is for Sleep|Mixed Models Analysis|||||0.30|-0.32|0.9424
71045132|NCT02709486|141599373|SUPERIORITY||Least Square Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.07|-0.5|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.50|-1.07|<.0001
71006362|NCT01855919|141520991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.7932|TWO_SIDED|95.0|-0.35|0.27||p-value is for Enjoyment of Life|Mixed Models Analysis|||||0.27|-0.35|0.7932
71006363|NCT01855919|141520991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.3761|TWO_SIDED|95.0|-0.4|0.15||p-value is for Average of 7 Items|Mixed Models Analysis|||||0.15|-0.40|0.3761
71006364|NCT01855919|141520992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.0049|TWO_SIDED|95.0|-0.71|-0.13||p-value is for Average Pain|Mixed Models Analysis|||||-0.13|-0.71|0.0049
71006365|NCT01855919|141520992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0442|TWO_SIDED|95.0|-0.69|-0.01||p-value is for Worst pain|Mixed Models Analysis|||||-0.01|-0.69|0.0442
71006366|NCT01855919|141520993|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.31||||0.0003|TWO_SIDED|95.0|1.13|1.53||p-value is for ≥30%|Mantel Haenszel|||||1.53|1.13|0.0003
71006367|NCT01855919|141520993|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.43||||0.0003|TWO_SIDED|95.0|1.18|1.75||p-value is for ≥50%|Mantel Haenszel|||||1.75|1.18|0.0003
71006368|NCT01855919|141520994|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.33||||0.0012|TWO_SIDED|95.0|1.12|1.58|||Mantel Haenszel|||||1.58|1.12|0.0012
71006369|NCT01855919|141520995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.0019|TWO_SIDED|95.0|-0.46|-0.1|||Mixed Models Analysis|||||-0.10|-0.46|0.0019
71006370|NCT01855919|141520996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.3012|TWO_SIDED|95.0|-1.03|0.32|||ANCOVA|||||0.32|-1.03|0.3012
71045133|NCT02709486|141599373|SUPERIORITY||Least Square Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.92|-0.32|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.32|-0.92|<.0001
71006371|NCT01855919|141520997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.27||||0.2581|TWO_SIDED|95.0|-0.93|3.47||p-value for Physical Functioning|ANCOVA|||||3.47|-0.93|0.2581
71006372|NCT01855919|141520997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58||||0.7208|TWO_SIDED|95.0|-2.62|3.79||p-value for Role (Physical)|ANCOVA|||||3.79|-2.62|0.7208
71006373|NCT01855919|141520997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.55||||0.2487|TWO_SIDED|95.0|-1.09|4.19||p-value for Bodily Pain|ANCOVA|||||4.19|-1.09|0.2487
71006374|NCT01855919|141520997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.94||||0.0151|TWO_SIDED|95.0|0.57|5.31||p-value for General Health|ANCOVA|||||5.31|0.57|0.0151
71006375|NCT01855919|141520997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.16||||0.4|TWO_SIDED|95.0|-1.54|3.85||p-value for Vitality|ANCOVA|||||3.85|-1.54|0.4000
71006376|NCT01855919|141520997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63||||0.2529|TWO_SIDED|95.0|-1.17|4.43||p-value for Social Functioning|ANCOVA|||||4.43|-1.17|0.2529
71006377|NCT01855919|141520997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.8042|TWO_SIDED|95.0|-3.55|2.75||p-value for Role(Emotional)|ANCOVA|||||2.75|-3.55|0.8042
71006378|NCT01855919|141520997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.21||||0.0058|TWO_SIDED|95.0|0.94|5.48||p-value is for Mental Health|ANCOVA|||||5.48|0.94|0.0058
71006379|NCT01855919|141520998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.5237|TWO_SIDED|95.0|-0.02|0.03|||ANCOVA|||||0.03|-0.02|0.5237
71006380|NCT01855919|141520999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.046|TWO_SIDED|95.0|-0.05|0.0||p-value for Work time missed|ANCOVA|||||0.00|-0.05|0.0460
71006381|NCT01855919|141520999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.0753|TWO_SIDED|95.0|-0.08|0.0||p-value for Impairment at work|ANCOVA|||||0.00|-0.08|0.0753
71006382|NCT01855919|141520999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.0795|TWO_SIDED|95.0|-0.08|0.0||p-value for Work productivity loss|ANCOVA|||||0.00|-0.08|0.0795
71006383|NCT01855919|141520999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.1466|TWO_SIDED|95.0|-0.06|0.01||p-value for Work activity impairment|ANCOVA|||||0.01|-0.06|0.1466
71006384|NCT03455530|141521007|SUPERIORITY||Mean Difference (Final Values)|0.73|||||TWO_SIDED|95.0|0.45|1.19|||Mixed Models Analysis||Ratio based on the mean difference from the log scale.|||1.19|0.45|
71101920|NCT03829514|141711588|OTHER|||||||0.05|||||||t-test, 2 sided|Signal intensity data were loess normalized and normalized data were used to perform a limma t-test with empirical Bayes smoothing to standard errors|||Proteins were identified and quantified using EncyclopeDIA and visualized with Scaffold DIA using 1% false discovery thresholds at both the protein and peptide level. Protein exclusive intensity values were assessed for quality using an in-house ProteiNorm app, a tool for systematic evaluation of normalization methods, imputation of missing values and comparisons of multiple differential abundance methods . Cyclic loess normalization. The normalized data were used to perform statistical analysis using linear models for microarray data (limma) with empirical Bayes (eBayes) smoothing to the standard errors. Proteins with p-value \< 0.05 were considered significant.|||0.05
71006385|NCT03455530|141521007|SUPERIORITY||Mean Difference (Final Values)|1.34|||||TWO_SIDED|95.0|0.55|3.24|||Mixed Models Analysis||Ratio based on the mean difference from the log scale.|||3.24|0.55|
71006386|NCT00740116|141521012|SUPERIORITY|||||||0.03||||||Statistical significance threshold was p \< 0.05|Wilcoxon (Mann-Whitney)|Mann-Whitney U-test, one-sided test||||||0.03
71006387|NCT00740116|141521013|SUPERIORITY|||||||0.07||||||Statistical significance threshold was p \< 0.05|Wilcoxon (Mann-Whitney)|Mann-Whitney U-test, one-sided test||||||0.07
71006388|NCT00740116|141521014|SUPERIORITY||Odds Ratio (OR)|0.44||||0.46|ONE_SIDED|95.0||0.97||Statistical significance threshold was p \< 0.05|Wilcoxon (Mann-Whitney)|Mann-Whitney U-test, one-sided test||||0.97||0.46
71006389|NCT00740116|141521015|SUPERIORITY|||||||0.46||||||p\< 0.05 for statistical significance|Wilcoxon (Mann-Whitney)|||||||0.46
71006390|NCT00740116|141521016|SUPERIORITY||Odds Ratio (OR)|0.36||||0.22|TWO_SIDED|95.0|0.05|2.72||Statistical significance threshold p-value \< 0.05|Fisher Exact|||||2.72|0.05|0.22
71006391|NCT00121485|141521024|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|200 patients (137 HMII and 67 XVE) provides 80% power (alpha= 0.05 (one-sided)) using a Blackwelder like analysis and a non-inferiority margin of 10%. The protocol specifies that once non-inferiority is proven, the data will be analyzed for superiority using closed testing methods.|Mean Difference (Final Values)|35.7||||2.5e-07|TWO_SIDED|95.0|24.5|46.9||Two (2) interim analysis were pre-specified in the protocol. The type I error rate was preserved at 5% by use of the O'Brien-Fleming spending function.|Fisher Exact|||Primary endpoint is 2-yr survival free of stroke or re-operation to repair/replace the device. Patients are a success if composite endpoint achieved. Patients urgently transplanted due to device failure are failures. Patients electively transplanted after reversal of co-morbidity will be considered success if they achieve 2 years of survival from day of VAD implant and no stroke. HMII is a success if the proportion of HMII pts achieving the composite endpoint is equal to or better than HM XVE||46.9|24.5|0.00000025
71006392|NCT01111331|141521039|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean ratio|100.89|STANDARD_DEVIATION|7.0|||TWO_SIDED|90.0|96.86|105.1|||ANOVA|Based on ANOVA with terms for subject and treatment|Standard deviation is actually the intra-individual geometric coefficient of variation (gCV)|Ratio calculated as empa plus warfarin divided by empa||105.10|96.86|
71006393|NCT01111331|141521040|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|100.64|STANDARD_DEVIATION|19.9||0.0021|TWO_SIDED|90.0|89.79|112.8||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|Based on ANOVA with terms for subject and treatment|Standard deviation is actually the intra-individual gCV|Ratio calculated as empa plus warfarin divided by empa||112.80|89.79|0.0021
71006394|NCT01111331|141521041|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|98.49|STANDARD_DEVIATION|5.7|||TWO_SIDED|90.0|95.29|101.8|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the geometric coefficient of variation (gCV)|Ratio calculated as empa plus warfarin divided by warfarin||101.80|95.29|
71006395|NCT01111331|141521042|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|97.89|STANDARD_DEVIATION|12.4||0.0001|TWO_SIDED|90.0|91.12|105.15|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the geometric coefficient of variation (gCV)|Ratio calculated as empa plus warfarin divided by warfarin||105.15|91.12|0.0001
71006396|NCT01111331|141521043|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|95.88|STANDARD_DEVIATION|4.5|||TWO_SIDED|90.0|93.4|98.43|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV|Ratio calculated as empa plus warfarin divided by warfarin||98.43|93.40|
71006397|NCT01111331|141521044|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|98.88|STANDARD_DEVIATION|12.7||0.0001|TWO_SIDED|90.0|91.84|106.47||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV|Ratio calculated as empa plus warfarin divided by warfarin||106.47|91.84|0.0001
71006398|NCT01111331|141521052|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|98.9|STANDARD_DEVIATION|5.3|||TWO_SIDED|90.0|95.89|102.0|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the geometric coefficient of variation (gCV)|Ratio calculated as empa plus warfarin divided by warfarin||102.00|95.89|
71006399|NCT01111331|141521059|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|96.09|STANDARD_DEVIATION|4.4|||TWO_SIDED|90.0|93.64|98.6|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV|Ratio calculated as empa plus warfarin divided by warfarin||98.60|93.64|
71006400|NCT01111331|141521066|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.87|||||TWO_SIDED|95.0|0.73|1.04|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline INR value||Difference calculated as empa plus warfarin minus warfarin||1.04|0.73|
71006401|NCT01111331|141521067|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.88|||||TWO_SIDED|95.0|0.79|0.98|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline INR value||Difference calculated as empa plus warfarin minus warfarin||0.98|0.79|
71006402|NCT01111331|141521068|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.99|||||TWO_SIDED|95.0|0.67|1.48|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline INR value||Difference calculated as empa plus warfarin minus warfarin||1.48|0.67|
71006403|NCT01111331|141521069|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.9|||||TWO_SIDED|95.0|0.79|1.02|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline PT value||Difference calculated as empa plus warfarin minus warfarin||1.02|0.79|
71045134|NCT02709486|141599373|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.07|-0.47|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.47|-1.07|<.0001
71045135|NCT02709486|141599373|SUPERIORITY||Least Square Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.05|-0.39|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.39|-1.05|<.0001
71006404|NCT01111331|141521070|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|1.12|||||TWO_SIDED|95.0|0.64|1.95|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline PT value||Difference calculated as empa plus warfarin minus warfarin||1.95|0.64|
71006405|NCT01111331|141521071|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.91|||||TWO_SIDED|95.0|0.84|0.98|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline PT value||Difference calculated as empa plus warfarin minus warfarin||0.98|0.84|
71006406|NCT01111331|141521072|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.97|||||TWO_SIDED|95.0|0.68|1.4|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline PT value||Difference calculated as empa plus warfarin minus warfarin||1.40|0.68|
71006407|NCT01111331|141521073|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.85|||||TWO_SIDED|95.0|0.47|1.51|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline PT value||Difference calculated as empa plus warfarin minus warfarin||1.51|0.47|
71045136|NCT02709486|141599373|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.09|-0.44|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.44|-1.09|<.0001
71006408|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|2.9||||0.3474|TWO_SIDED|95.0|-3.3|9.1|||ANOVA|Analysis of variance for repeated measures||Dryness - Study eye - Day 15±2 The model included fixed effect terms for time point, baseline covariate (i.e. the day 1 - pre-dose value) and treatment. Time point was specified as a repeated measurement.||9.1|-3.3|0.3474
71006409|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.1327|TWO_SIDED|95.0|-8.2|4.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Dryness - Study eye - Day 15±2||4.3|-8.2|0.1327
71006410|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|-4.8||||0.1327|TWO_SIDED|95.0|-11.2|1.6|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Dryness - Study eye - Day 15±2||1.6|-11.2|0.1327
71006411|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.2237|TWO_SIDED|95.0|-2.5|10.0|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Foreign body sensation - Study eye - Day 15±2||10.0|-2.5|0.2237
71006412|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.4905|TWO_SIDED|95.0|-8.4|4.1|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Foreign body sensation - Study eye - Day 15±2||4.1|-8.4|0.4905
71006413|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|-5.9||||0.0687|TWO_SIDED|95.0|-12.3|0.5|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Foreign body sensation - Study eye - Day 15±2||0.5|-12.3|0.0687
71006414|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.7609|TWO_SIDED|95.0|-4.2|5.6|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Burning/Stinging - Study eye - Day 15±2||5.6|-4.2|0.7609
71006415|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.6428|TWO_SIDED|95.0|-6.0|3.8|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Burning/Stinging - Study eye - Day 15±2||3.8|-6.0|0.6428
71006416|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.4599|TWO_SIDED|95.0|-6.9|3.2|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Burning/Stinging - Study eye - Day 15±2||3.2|-6.9|0.4599
71006417|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.4217|TWO_SIDED|95.0|-4.6|10.5|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Itching - Study eye - Day 15±2||10.5|-4.6|0.4217
71006418|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|0.503||||-2.5|TWO_SIDED|95.0|-10.0|5.0|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Itching - Study eye - Day 15±2||5.0|-10.0|-2.5
71006419|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.4599|TWO_SIDED|95.0|-6.9|3.2|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Itching - Study eye - Day 15±2||3.2|-6.9|0.4599
71006420|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.6157|TWO_SIDED|95.0|-2.6|4.4|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Pain - Study eye - Day 15±2||4.4|-2.6|0.6157
71006421|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.912|TWO_SIDED|95.0|-3.7|3.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Pain - Study eye - Day 15±2||3.3|-3.7|0.9120
71006422|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.5463|TWO_SIDED|95.0|-4.6|2.5|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Pain - Study eye - Day 15±2||2.5|-4.6|0.5463
71006423|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.9065|TWO_SIDED|95.0|-5.9|5.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Sticky Feeling - Study eye - Day 15±2||5.3|-5.9|0.9065
71006424|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.5065|TWO_SIDED|95.0|-7.3|3.7|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Sticky Feeling - Study eye - Day 15±2||3.7|-7.3|0.5065
71006425|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.5977|TWO_SIDED|95.0|-7.1|4.2|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Sticky Feeling - Study eye - Day 15±2||4.2|-7.1|0.5977
71006426|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.2785|TWO_SIDED|95.0|-6.3|1.9|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Blurred Vision - Study eye - Day 15±2||1.9|-6.3|0.2785
71006427|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.7454|TWO_SIDED|95.0|-4.6|3.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Blurred vision - Study eye - Day 15±2||3.3|-4.6|0.7454
71006428|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.4588|TWO_SIDED|95.0|-2.7|5.9|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Blurred vision - Study eye - Day 15±2||5.9|-2.7|0.4588
71006429|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|4.3||||0.2812|TWO_SIDED|95.0|-3.7|12.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Photophobia - Study eye - Day 15±2||12.3|-3.7|0.2812
71006430|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.6811|TWO_SIDED|95.0|-6.5|9.8|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Photophobia - Study eye - Day 15±2||9.8|-6.5|0.6811
71006431|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.5169|TWO_SIDED|95.0|-10.8|5.6|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Photophobia - Study eye - Day 15±2||5.6|-10.8|0.5169
71006432|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.7874|TWO_SIDED|95.0|-5.9|7.8|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Dryness - Non Study eye - Day 15±2||7.8|-5.9|0.7874
71006433|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.8299|TWO_SIDED|95.0|-7.6|6.1|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Dryness - Non Study eye - Day 15±2||6.1|-7.6|0.8299
71006434|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.6386|TWO_SIDED|95.0|-8.7|5.4|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Dryness - Non Study eye - Day 15±2||5.4|-8.7|0.6386
71006435|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.0132|TWO_SIDED|95.0|1.3|10.2|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Foreign body sensation - Non Study eye - Day 15±2||10.2|1.3|0.0132
71006436|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.7177|TWO_SIDED|95.0|-5.3|3.7|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Foreign body sensation - Non Study eye - Day 15±2||3.7|-5.3|0.7177
71006437|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|-6.5||||0.0077|TWO_SIDED|95.0|-11.2|-1.9|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Foreign body sensation - Non Study eye - Day 15±2||-1.9|-11.2|0.0077
71006438|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.0301|TWO_SIDED|95.0|0.6|10.0|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Burning/Stinging - Non Study eye - Day 15±2||10.0|0.6|0.0301
71006439|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.8657|TWO_SIDED|95.0|-4.3|5.1|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Burning/Stinging - Non Study eye - Day 15±2||5.1|-4.3|0.8657
71006440|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|-4.9||||0.044|TWO_SIDED|95.0|-9.7|-0.1|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Burning/Stinging - Non Study eye - Day 15±2||-0.1|-9.7|0.0440
71006441|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|4.1||||0.1351|TWO_SIDED|95.0|-1.4|9.6|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Itching - Non Study eye - Day 15±2||9.6|-1.4|0.1351
71006442|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.8821|TWO_SIDED|95.0|-6.0|5.2|||ANCOVA|||Analysis of variance on changes from baseline in ocular tolerability - Itching - Non Study eye - Day 15±2||5.2|-6.0|0.8821
71006443|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|-4.5||||0.1208|TWO_SIDED|95.0|-10.3|1.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Itching - Non Study eye - Day 15±2||1.3|-10.3|0.1208
71006444|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.944|TWO_SIDED|95.0|-3.3|3.5|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Pain - Non Study eye - Day 15±2||3.5|-3.3|0.9440
71006445|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.4903|TWO_SIDED|95.0|-2.2|4.5|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Pain - Non Study eye - Day 15±2||4.5|-2.2|0.4903
71006446|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.5364|TWO_SIDED|95.0|-2.3|4.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Pain - Non Study eye - Day 15±2||4.3|-2.3|0.5364
71006447|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.51|TWO_SIDED|95.0|-2.9|5.7|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Sticky feeling - Non Study eye - Day 15±2||5.7|-2.9|0.5100
71006448|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.1132|TWO_SIDED|95.0|-0.9|7.8|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Sticky feeling - Non Study eye - Day 15±2||7.8|-0.9|0.1132
71006449|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.3457|TWO_SIDED|95.0|-2.4|6.5|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Sticky feeling - Non Study eye - Day 15±2||6.5|-2.4|0.3457
71006450|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|4.3||||0.0185|TWO_SIDED|95.0|0.8|7.9|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Blurred vision - Non Study eye - Day 15±2||7.9|0.8|0.0185
71006451|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|3.6||||0.0408|TWO_SIDED|95.0|0.2|7.1|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Blurred vision - Non Study eye - Day 15±2||7.1|0.2|0.0408
71006452|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.6992|TWO_SIDED|95.0|-4.4|3.0|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Blurred vision - Non Study eye - Day 15±2||3.0|-4.4|0.6992
71006453|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|5.9||||0.0905|TWO_SIDED|95.0|-1.0|12.8|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Photophobia - Non Study eye - Day 15±2||12.8|-1.0|0.0905
71006454|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.3054|TWO_SIDED|95.0|-3.4|10.4|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Photophobia - Non Study eye - Day 15±2||10.4|-3.4|0.3054
71006455|NCT03031327|141521079|SUPERIORITY||Mean Difference (Final Values)|0.5024||||0.5024|TWO_SIDED|95.0|-9.6|4.8|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Photophobia - Non Study eye - Day 15±2||4.8|-9.6|0.5024
71006456|NCT03031327|141521081|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.1226|TWO_SIDED|95.0|-0.1|0.8|||Student t-test pooled|Student t-test with pool method for estimating common variance on changes from baseline in ocular surface vital staining||Study eye - Day 15±2 pre-dose||0.8|-0.1|0.1226
71006457|NCT03031327|141521081|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.2854|TWO_SIDED|95.0|-0.2|0.7|||Student t-test pooled|Student t-test with pool method for estimating common variance on changes from baseline in ocular surface vital staining||Study eye - Day 15±2 pre-dose||0.7|-0.2|0.2854
71006458|NCT03031327|141521081|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.6525|TWO_SIDED|95.0|-0.6|0.4|||Student t-test pooled|Student t-test pooled method for estimating common variance on changes from baseline in ocular surface vital staining -||Student t-test on changes from baseline in ocular surface vital staining - Study eye - Day 15±2 pre-dose||0.4|-0.6|0.6525
71006459|NCT03031327|141521081|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.8843|TWO_SIDED|95.0|-0.4|0.5|||Student t-test pooled|Student t-test pooled method for estimating common variance on changes from baseline in ocular surface vital staining -||Non Study eye - Day 15±2 pre-dose||0.5|-0.4|0.8843
71006460|NCT03031327|141521081|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.0806|TWO_SIDED|95.0|-0.6|0.0|||Student t-test pooled|Student t-test pooled method for estimating common variance on changes from baseline in ocular surface vital staining||Non Study eye - Day 15±2 pre-dose||0.0|-0.6|0.0806
71006461|NCT03031327|141521081|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.0628|TWO_SIDED|95.0|-0.7|0.0|||Student t-test pooled|Student t-test pooled method for estimating common variance on changes from baseline in ocular surface vital staining||Non Study eye - Day 15±2 pre-dose||0.0|-0.7|0.0628
71006462|NCT03031327|141521082|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.2004|TWO_SIDED|95.0|-0.2|0.9|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in Schirmer-I test - Study eye - Day 15±2 pre-dose||0.9|-0.2|0.2004
71006463|NCT03031327|141521082|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.5413|TWO_SIDED|95.0|-0.3|0.6|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in Schirmer-I test - Study eye - Day 15±2 pre-dose||0.6|-0.3|0.5413
71006464|NCT03031327|141521082|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.4607|TWO_SIDED|95.0|-0.8|0.4|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in Schirmer-I test - Study eye - Day 15±2 pre-dose||0.4|-0.8|0.4607
71006465|NCT03031327|141521082|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.1248|TWO_SIDED|95.0|-0.2|1.4|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in Schirmer-I test - Non Study eye - Day 15±2 pre-dose||1.4|-0.2|0.1248
71006466|NCT03031327|141521082|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.0624|TWO_SIDED|95.0|0.0|1.1|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in Schirmer-I test - Non Study eye - Day 15±2 pre-dose||1.1|0.0|0.0624
71006467|NCT03031327|141521082|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.7927|TWO_SIDED|95.0|-1.0|0.8|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in Schirmer-I test - Non Study eye - Day 15±2 pre-dose||0.8|-1.0|0.7927
71006468|NCT03031327|141521083|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9717|TWO_SIDED|95.0|-0.6|0.7|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in TFBUT - Study eye - Day 15±2 pre-dose||0.7|-0.6|0.9717
71006469|NCT03031327|141521083|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.7386|TWO_SIDED|95.0|-0.6|0.9|||Student t-test pooled|Pooled method for estimating common variance was used||Study eye - Day 15±2 pre-dose||0.9|-0.6|0.7386
71006470|NCT03031327|141521083|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.7498|TWO_SIDED|95.0|-0.6|0.8|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in TFBUT - Study eye - Day 15±2 pre-dose||0.8|-0.6|0.7498
71006471|NCT03031327|141521083|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.3229|TWO_SIDED|95.0|-1.1|0.4|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in TFBUT - Non Study eye - Day 15±2 pre-dose||0.4|-1.1|0.3229
71006472|NCT03031327|141521083|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.57|TWO_SIDED|95.0|-0.5|0.9|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in TFBUT - Non Study eye - Day 15±2 pre-dose||0.9|-0.5|0.5700
71006473|NCT03031327|141521083|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.1197|TWO_SIDED|95.0|-0.2|1.3|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in TFBUT - Non Study eye - Day 15±2 pre-dose||1.3|-0.2|0.1197
71006474|NCT03031327|141521084|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.8787|TWO_SIDED|95.0|-0.6|0.6|||Student t-test pooled|||Student t-test on changes from baseline in BCDVA - Study eye - Day 15±2 pre-dose||0.6|-0.6|0.8787
71006475|NCT03031327|141521084|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.8159|TWO_SIDED|95.0|-0.5|0.7|||Student t-test pooled|||Student t-test on changes from baseline in BCDVA - Study eye - Day 15±2 pre-dose||0.7|-0.5|0.8159
71006476|NCT03031327|141521084|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.6525|TWO_SIDED|95.0|-0.4|0.6|||Student t-test pooled|||Student t-test on changes from baseline in BCDVA - Study eye - Day 15±2 pre-dose||0.6|-0.4|0.6525
71006477|NCT03031327|141521084|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.334|TWO_SIDED|95.0|-1.0|0.4|||Student t-test pooled|||Student t-test on changes from baseline in BCDVA - Non Study eye - Day 15±2 pre-dose||0.4|-1.0|0.3340
71006478|NCT03031327|141521084|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9749|TWO_SIDED|95.0|-0.7|0.7|||Student t-test pooled|||Student t-test on changes from baseline in BCDVA - Non Study eye - Day 15±2 pre-dose||0.7|-0.7|0.9749
71006479|NCT03031327|141521084|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.1984|TWO_SIDED|95.0|-0.2|0.9|||Student t-test pooled|||Student t-test on changes from baseline in BCDVA - Non Study eye - Day 15±2 pre-dose||0.9|-0.2|0.1984
71006480|NCT03031327|141521085|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.6497|TWO_SIDED|95.0|-10.5|16.4|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in SANDE scores - Frequency of symptoms - Day 15±2 pre-dose||16.4|-10.5|0.6497
71006481|NCT03031327|141521085|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.1443|TWO_SIDED|95.0|-16.5|2.6|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in SANDE scores - Frequency of symptoms - Day 15±2 pre-dose||2.6|-16.5|0.1443
71006482|NCT03031327|141521085|SUPERIORITY||Mean Difference (Final Values)|-9.9||||0.0751|TWO_SIDED|95.0|-20.9|1.1|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in SANDE scores - Frequency of symptoms - Day 15±2 pre-dose||1.1|-20.9|0.0751
71006483|NCT03031327|141521085|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.5015|TWO_SIDED|95.0|-7.9|15.5|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in SANDE scores - Severity of symptoms - Day 15±2 pre-dose||15.5|-7.9|0.5015
71006484|NCT03031327|141521085|SUPERIORITY||Mean Difference (Final Values)|-4.1||||0.3217|TWO_SIDED|95.0|-12.5|4.4|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in SANDE scores - Severity of symptoms - Day 15±2 pre-dose||4.4|-12.5|0.3217
71006485|NCT03031327|141521085|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.1026|TWO_SIDED|95.0|-17.5|1.8|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in SANDE scores - Severity of symptoms - Day 15±2 pre-dose||1.8|-17.5|0.1026
71006486|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Meibomian Glands - Study eye - Day 15±2 pre-dose||||1.000
71006487|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Meibomian Glands - Study eye - Day 15±2 pre-dose||||1.000
71006488|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Meibomian Glands - Study eye - Day 15±2 pre-dose||||1.000
71006489|NCT03031327|141521086|SUPERIORITY|||||||0.4101|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Meibomian Glands - Non Study eye - Day 15±2 pre-dose||||0.4101
71006490|NCT03031327|141521086|SUPERIORITY|||||||0.4101|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Meibomian Glands - Non Study eye - Day 15±2 pre-dose||||0.4101
71045137|NCT02709486|141599373|SUPERIORITY||Least Square Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.17||0.0005|TWO_SIDED|95.0|-0.93|-0.26|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.26|-0.93|0.0005
71045138|NCT02709486|141599373|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17||0.0004|TWO_SIDED|95.0|-0.93|-0.27|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.27|-0.93|0.0004
71045139|NCT02709486|141599375|SUPERIORITY||Least Square Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.95|-0.42|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.42|-0.95|<.0001
71045140|NCT02709486|141599375|SUPERIORITY||Least Square Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.14||0.0014|TWO_SIDED|95.0|-0.7|-0.17|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.17|-0.70|0.0014
71045141|NCT02709486|141599375|SUPERIORITY||Least Square Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.09|-0.53|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.53|-1.09|<.0001
71045142|NCT02709486|141599375|SUPERIORITY||Least Square Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.08|-0.51|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.51|-1.08|<.0001
71045143|NCT02709486|141599375|SUPERIORITY||Least Square Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.93|-0.33|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.33|-0.93|<.0001
71045144|NCT02709486|141599375|SUPERIORITY||Least Square Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.06|-0.47|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.47|-1.06|<.0001
71045145|NCT02709486|141599375|SUPERIORITY||Least Square Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.11|-0.46|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.46|-1.11|<.0001
71006491|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Meibomian Glands - Non Study eye - Day 15±2 pre-dose||||1.000
71006492|NCT03031327|141521086|SUPERIORITY|||||||0.4101|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Study eye - Day 15±2 pre-dose||||0.4101
71006493|NCT03031327|141521086|SUPERIORITY|||||||0.4101|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Study eye - Day 15±2 pre-dose||||0.4101
71006494|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Study eye - Day 15±2 pre-dose||||1.000
71006495|NCT03031327|141521086|SUPERIORITY|||||||0.4101|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Non Study eye - Day 15±2 pre-dose||||0.4101
71006496|NCT03031327|141521086|SUPERIORITY|||||||0.4101|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Non Study eye - Day 15±2 pre-dose||||0.4101
71006497|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Non Study eye - Day 15±2 pre-dose||||1.000
71006498|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Study eye - Day 15±2 pre-dose||||1.000
71006499|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Study eye - Day 15±2 pre-dose||||1.000
71006500|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Study eye - Day 15±2 pre-dose||||1.000
71006501|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Non Study eye - Day 15±2 pre-dose||||1.000
71006502|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Non Study eye - Day 15±2 pre-dose||||1.000
71006503|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Non Study eye - Day 15±2 pre-dose||||1.000
71006504|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Study eye - Day 15±2 pre-dose||||1.000
71006505|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Study eye - Day 15±2 pre-dose||||1.000
71045146|NCT02709486|141599375|SUPERIORITY||Least Square Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.15|-0.5|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.50|-1.15|<.0001
71045147|NCT02709486|141599375|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.0|-0.34|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.34|-1.00|<.0001
71045148|NCT02709486|141599375|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.0|-0.35|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.35|-1.00|<.0001
71045149|NCT02709486|141599377|SUPERIORITY||Least Square Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.33|-0.12|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.12|-0.33|<.0001
71101921|NCT01339091|141711589|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority hypothesis test is a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the 95% CI for the difference in response rates in the ITT population is greater than -10% the NI of dalbavancin to vancomycin/linezolid will be concluded.|Difference in Proportions|1.5|||||TWO_SIDED|95.0|-4.6|7.9|||||Confidence intervals were adjusted for fever at baseline|||7.9|-4.6|
71006506|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Study eye - Day 15±2 pre-dose||||1.000
71006507|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Non Study eye - Day 15±2 pre-dose||||1.000
71006508|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Non Study eye - Day 15±2 pre-dose||||1.000
71006509|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Non Study eye - Day 15±2 pre-dose||||1.000
71006510|NCT03031327|141521086|SUPERIORITY|||||||0.5267|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Study eye - Day 15±2 pre-dose||||0.5267
71006511|NCT03031327|141521086|SUPERIORITY|||||||0.2633|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Study eye - Day 15±2 pre-dose||||0.2633
71006512|NCT03031327|141521086|SUPERIORITY|||||||0.6552|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Study eye - Day 15±2 pre-dose||||0.6552
71006513|NCT03031327|141521086|SUPERIORITY|||||||0.1262|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Non Study eye - Day 15±2 pre-dose||||0.1262
71006514|NCT03031327|141521086|SUPERIORITY|||||||0.2094|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Non Study eye - Day 15±2 pre-dose||||0.2094
71045150|NCT02709486|141599377|SUPERIORITY||Least Square Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.05||0.0022|TWO_SIDED|95.0|-0.27|-0.06|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.06|-0.27|0.0022
71101922|NCT01149460|141711607|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means (T/R)|111.34|||||TWO_SIDED|90.0|100.54|123.29|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||123.29|100.54|
71101923|NCT01149460|141711608|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means (T/R)|100.01|||||TWO_SIDED|90.0|96.34|103.82|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||103.82|96.34|
71006515|NCT03031327|141521086|SUPERIORITY||Hodges Lehmann estimation|-1.0||||0.0377|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Non Study eye - Day 15±2 pre-dose||0.0|-1.0|0.0377
71006516|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Study eye - Day 15±2 pre-dose||||1.000
71006517|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Study eye - Day 15±2 pre-dose||||1.000
71006518|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Study eye - Day 15±2 pre-dose||||1.000
71006519|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Non Study eye - Day 15±2 pre-dose||||1.000
71006520|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Non Study eye - Day 15±2 pre-dose||||1.000
71006521|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Non Study eye - Day 15±2 pre-dose||||1.000
71006522|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Study eye - Day 15±2 pre-dose||||1.000
71006523|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Study eye - Day 15±2 pre-dose||||1.000
71006524|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Study eye - Day 15±2 pre-dose||||1.000
71006525|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Non Study eye - Day 15±2 pre-dose||||1.000
71006526|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Non Study eye - Day 15±2 pre-dose||||1.000
71006527|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Non Study eye - Day 15±2 pre-dose||||1.000
71006528|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Study eye - Day 15±2 pre-dose||||1.000
71006529|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Study eye - Day 15±2 pre-dose||||1.000
71006530|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Study eye - Day 15±2 pre-dose||||1.000
71006531|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Non Study eye - Day 15±2 pre-dose||||1.000
71006532|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Non Study eye - Day 15±2 pre-dose||||1.000
71006533|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Non Study eye - Day 15±2 pre-dose||||1.000
71006534|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Study eye - Day 15±2 pre-dose||||1.000
71006535|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Study eye - Day 15±2 pre-dose||||1.000
71006536|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Study eye - Day 15±2 pre-dose||||1.000
71006537|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Non Study eye - Day 15±2 pre-dose||||1.000
71006538|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Non Study eye - Day 15±2 pre-dose||||1.000
71006539|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Non Study eye - Day 15±2 pre-dose||||1.000
71006540|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Study eye - Day 15±2 pre-dose||||1.000
71101924|NCT01149460|141711609|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means (T/R)|100.01|||||TWO_SIDED|90.0|96.38|103.78|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||103.78|96.38|
71006541|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Study eye - Day 15±2 pre-dose||||1.000
71006542|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Study eye - Day 15±2 pre-dose||||1.000
71006543|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Non Study eye - Day 15±2 pre-dose||||1.000
71006544|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Non Study eye - Day 15±2 pre-dose||||1.000
71006545|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Non Study eye - Day 15±2 pre-dose||||1.000
71006546|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Study eye - Day 15±2 pre-dose||||1.000
71006547|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Study eye - Day 15±2 pre-dose||||1.000
71006548|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Study eye - Day 15±2 pre-dose||||1.000
71006549|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Non Study eye - Day 15±2 pre-dose||||1.000
71006550|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Non Study eye - Day 15±2 pre-dose||||1.000
71006551|NCT03031327|141521086|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Non Study eye - Day 15±2 pre-dose||||1.000
71006552|NCT03031327|141521087|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.5842|TWO_SIDED|95.0|-1.5|2.6|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in IOP - Study eye - Day 15±2 pre-dose||2.6|-1.5|0.5842
71006553|NCT03031327|141521087|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.4606|TWO_SIDED|95.0|-2.2|1.0|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in IOP - Study eye - Day 15±2 pre-dose||1.0|-2.2|0.4606
71006554|NCT03031327|141521087|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.2319|TWO_SIDED|95.0|-3.0|0.8|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in IOP - Study eye - Day 15±2 pre-dose||0.8|-3.0|0.2319
71006555|NCT03031327|141521087|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.6018|TWO_SIDED|95.0|-2.3|1.4|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in IOP - Non Study eye - Day 15±2 pre-dose||1.4|-2.3|0.6018
71006556|NCT03031327|141521087|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.4857|TWO_SIDED|95.0|-2.2|1.1|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in IOP - Non Study eye - Day 15±2 pre-dose||1.1|-2.2|0.4857
71006557|NCT03031327|141521087|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.9015|TWO_SIDED|95.0|-2.0|1.8|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in IOP - Non Study eye - Day 15±2 pre-dose||1.8|-2.0|0.9015
71006558|NCT03031327|141521088|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.3574|TWO_SIDED|95.0|-0.1|0.3|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in corneal sensitivity - Study eye - Day 15±2 pre-dose||0.3|-0.1|0.3574
71006559|NCT03031327|141521088|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.3574|TWO_SIDED|95.0|-0.1|0.3|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in corneal sensitivity - Study eye - Day 15±2 pre-dose||0.3|-0.1|0.3574
71101925|NCT01149460|141711610|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means (T/R)|103.48|||||TWO_SIDED|90.0|97.87|109.41|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||109.41|97.87|
71006560|NCT03031327|141521088|SUPERIORITY||Mean Difference (Final Values)|0.0||||0|TWO_SIDED|95.0|0.0|0.0||P-value is NA due to the measured values of corneal sensitivity equal to zero.|Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in corneal sensitivity - Study eye - Day 15±2 pre-dose||0.0|0.0|00
71101926|NCT01149460|141711611|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means (T/R)|99.2|||||TWO_SIDED|90.0|97.14|101.31|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||101.31|97.14|
71101927|NCT01149460|141711612|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means|99.1|||||TWO_SIDED|90.0|97.04|101.19|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||101.19|97.04|
71101928|NCT00266032|141711613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.0|STANDARD_DEVIATION|29.0|<|0.0001||95.0|-29.0|-20.0|||t-test, 2 sided||Mean of Yaz flexible regimen minus mean of Yaz standard was tested|Primary variable was tested for the hypothesis, whether the means are equal against the alternative (means are different) at a level of significance of alpha = 0.05 (t-test). For power calculation, a normal distribution, a absolute difference of 10 days, a Standard Deviation of 28 days and a drop-out rate of 40% was assumed.||-20|-29|<0.0001
71006561|NCT03031327|141521088|SUPERIORITY||Mean Difference (Final Values)|0.0||||0|TWO_SIDED|95.0|0.0|0.0||P-value is NA due to the measured values of corneal sensitivity equal to zero.|Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in corneal sensitivity - Non Study eye - Day 15±2 pre-dose||0.0|0.0|00
71101929|NCT01220687|141711658|SUPERIORITY||Mean Difference (Final Values)|9.0||||0.0012|TWO_SIDED||||||t-test, 2 sided|||||||0.0012
71006562|NCT03031327|141521088|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.1|TWO_SIDED|95.0|-0.1|0.3|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in corneal sensitivity - Non Study eye - Day 15±2 pre-dose||0.3|-0.1|0.1
71006563|NCT03031327|141521088|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.1|TWO_SIDED|95.0|-0.1|0.3|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in corneal sensitivity - Non Study eye - Day 15±2 pre-dose||0.3|-0.1|0.1
71006564|NCT00211536|141521089|NON_INFERIORITY_OR_EQUIVALENCE|For the average A1C, the goal was to show non-inferiority of MIP compared to SC. The minimal clinically relevant increase in A1C (%) was set at 0.50%. The between-subjects standard deviation of A1C was assumed to be 1.0% based on previous studies.|Least square means|0.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.05|ONE_SIDED|95.0||0.5|||Mixed Models Analysis|Repeated measures analysis of variance, adjusting for baseline A1C using SAS Proc Mixed to compare A1C trends over time between the treatment groups||Sample size calculations were performed on the primary endpoint: the average glycosylated hemoglobin (A1C). Sample size was estimated using a two-sample, one-sided t-test with a significance level of 0.05. The projected sample size of 50 subjects per treatment group provides 79% power to reject the null hypothesis in favor of the alternative hypothesis that the average A1C in both the MIP and SC groups are equivalent, assuming an effect size of 0.50% and a standard deviation of 1.0%.||0.5||<0.05
71006565|NCT00003389|141521103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.32|TWO_SIDED||||||Log Rank|Stratified log rank test was performed.||||||0.32
71006566|NCT00003389|141521104|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86|TWO_SIDED||||||Log Rank|Stratified log rank test was performed.||||||0.86
71006567|NCT04657003|141521151|SUPERIORITY||LSMean Mean Difference (Net)|-10.1|||<|0.001|TWO_SIDED|95.0|-11.5|-8.8|||Mixed Models Analysis|||||-8.8|-11.5|<0.001
71006568|NCT04657003|141521151|SUPERIORITY||LSMean Mean Difference (Net)|-12.4|||<|0.001|TWO_SIDED|95.0|-13.7|-11.0|||Mixed Models Analysis|||||-11.0|-13.7|<0.001
71006569|NCT04657003|141521152|SUPERIORITY||Odds Ratio (OR)|10.75|||<|0.001|TWO_SIDED|95.0|7.3|15.84|||Regression, Logistic|||||15.84|7.30|<0.001
71006570|NCT04657003|141521152|SUPERIORITY||Odds Ratio (OR)|15.28|||<|0.001|TWO_SIDED|95.0|10.08|23.14|||Regression, Logistic|||||23.14|10.08|<0.001
71101930|NCT01220687|141711659|SUPERIORITY||Rate Ratio|1.91|||<|0.0001|TWO_SIDED|95.0|1.68|2.18|||Poisson|||||2.18|1.68|<0.0001
71006571|NCT04657003|141521153|SUPERIORITY||Odds Ratio (OR)|20.94|||<|0.001|TWO_SIDED|95.0|13.06|33.58|||Regression, Logistic|||||33.58|13.06|<0.001
71006572|NCT04657003|141521153|SUPERIORITY||Odds Ratio (OR)|27.5|||<|0.001|TWO_SIDED|95.0|17.04|44.39|||Regression, Logistic|||||44.39|17.04|<0.001
71006573|NCT04657003|141521154|SUPERIORITY||Odds Ratio (OR)|28.38|||<|0.001|TWO_SIDED|95.0|13.81|58.31|||Regression, Logistic|||||58.31|13.81|<0.001
71006574|NCT04657003|141521154|SUPERIORITY||Odds Ratio (OR)|43.6|||<|0.001|TWO_SIDED|95.0|21.2|89.67|||Regression, Logistic|||||89.67|21.20|<0.001
71006575|NCT04657003|141521155|SUPERIORITY||Odds Ratio (OR)|28.54|||<|0.001|TWO_SIDED|95.0|9.73|83.73|||Regression, Logistic|||||83.73|9.73|<0.001
71006576|NCT04657003|141521155|SUPERIORITY||Odds Ratio (OR)|49.68|||<|0.001|TWO_SIDED|95.0|17.03|144.94|||Regression, Logistic|||||144.94|17.03|<0.001
71006577|NCT04657003|141521156|SUPERIORITY||LSMean Mean Difference (Net)|-10.3|||<|0.001|TWO_SIDED|95.0|-11.7|-8.8|||Mixed Models Analysis|||||-8.8|-11.7|<0.001
71006578|NCT04657003|141521156|SUPERIORITY||LSMean Mean Difference (Net)|-12.4|||<|0.001|TWO_SIDED|95.0|-13.8|-11.0|||Mixed Models Analysis|||||-11.0|-13.8|<0.001
71006579|NCT04657003|141521157|SUPERIORITY||LSMean Mean Difference (Net)|-3.7|||<|0.001|TWO_SIDED|95.0|-4.2|-3.2|||Mixed Models Analysis|||||-3.2|-4.2|<0.001
71101931|NCT03715829|141711674|SUPERIORITY||Least Squares Mean Difference (Net)|-23.2|STANDARD_ERROR_OF_MEAN|5.62|<|0.0001|TWO_SIDED|90.0|-32.53|-13.96||Hochberg's step-up procedure was conducted to compare ritlecitinib 200mg - 50mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. Hochberg adjusted p-value is presented here.|ANCOVA|||||-13.96|-32.53|<0.0001
71006580|NCT04657003|141521157|SUPERIORITY||LSMean Mean Difference (Net)|-4.5|||<|0.001|TWO_SIDED|95.0|-5.0|-4.0|||Mixed Models Analysis|||||-4.0|-5.0|<0.001
71006581|NCT04657003|141521158|SUPERIORITY||LSMean Mean Difference (Net)|-1.97|||<|0.001|TWO_SIDED|95.0|-2.15|-1.8|||Mixed Models Analysis|||||-1.80|-2.15|<0.001
71006582|NCT04657003|141521158|SUPERIORITY||LSMean Mean Difference (Net)|-2.06|||<|0.001|TWO_SIDED|95.0|-2.24|-1.88|||Mixed Models Analysis|||||-1.88|-2.24|<0.001
71006583|NCT04657003|141521159|SUPERIORITY||Odds Ratio (OR)|28.01|||<|0.001|TWO_SIDED|95.0|17.21|45.59|||Regression, Logistic|||||45.59|17.21|<0.001
71006584|NCT04657003|141521159|SUPERIORITY||Odds Ratio (OR)|34.19|||<|0.001|TWO_SIDED|95.0|20.27|57.67|||Regression, Logistic|||||57.67|20.27|<0.001
71006585|NCT04657003|141521160|SUPERIORITY||Odds Ratio (OR)|42.11|||<|0.001|TWO_SIDED|95.0|25.61|69.26|||Regression, Logistic|||||69.26|25.61|<0.001
71006586|NCT04657003|141521160|SUPERIORITY||Odds Ratio (OR)|58.67|||<|0.001|TWO_SIDED|95.0|34.29|100.37|||Regression, Logistic|||||100.37|34.29|<0.001
71006587|NCT04657003|141521161|SUPERIORITY||Odds Ratio (OR)|42.55|||<|0.001|TWO_SIDED|95.0|20.46|88.5|||Regression, Logistic|||||88.50|20.46|<0.001
71006588|NCT04657003|141521161|SUPERIORITY||Odds Ratio (OR)|54.3|||<|0.001|TWO_SIDED|95.0|26.0|113.38|||Regression, Logistic|||||113.38|26.00|<0.001
71006589|NCT04657003|141521162|SUPERIORITY||LSMean Mean Difference (Net)|-46.79|||<|0.001|TWO_SIDED|95.0|-52.67|-40.91|||Mixed Models Analysis|||||-40.91|-52.67|<0.001
71006590|NCT04657003|141521162|SUPERIORITY||LSMean Mean Difference (Net)|-49.25|||<|0.001|TWO_SIDED|95.0|-55.18|-43.33|||Mixed Models Analysis|||||-43.33|-55.18|<0.001
71006591|NCT04657003|141521163|SUPERIORITY||LSMean Mean Difference (Net)|-7.8|||<|0.001|TWO_SIDED|95.0|-9.2|-6.4|||Mixed Models Analysis|||||-6.4|-9.2|<0.001
71006592|NCT04657003|141521163|SUPERIORITY||LSMean Mean Difference (Net)|-10.4|||<|0.001|TWO_SIDED|95.0|-11.8|-8.9|||Mixed Models Analysis|||||-8.9|-11.8|<0.001
71006593|NCT04657003|141521164|SUPERIORITY||Estimate Difference|-4.61|||<|0.001|TWO_SIDED|95.0|-7.11|-2.03|||Mixed Models Analysis|||||-2.03|-7.11|<0.001
71006594|NCT04657003|141521165|SUPERIORITY||Estimate Difference|-3.36||||0.112|TWO_SIDED|95.0|-7.36|0.81|||Mixed Models Analysis|||||0.81|-7.36|0.112
71006595|NCT04657003|141521166|SUPERIORITY||Estimate Difference|7.02|||<|0.001|TWO_SIDED|95.0|4.4|9.71|||Mixed Models Analysis|||||9.71|4.40|<0.001
71006596|NCT04657003|141521167|SUPERIORITY||Estimate Difference|-23.3|||<|0.001|TWO_SIDED|95.0|-27.5|-18.9|||Mixed Models Analysis|||||-18.9|-27.5|<0.001
71006597|NCT04657003|141521168|SUPERIORITY||Estimate Difference|-24.2|||<|0.001|TWO_SIDED|95.0|-28.6|-19.6|||Mixed Models Analysis|||||-19.6|-28.6|<0.001
71006598|NCT04657003|141521169|SUPERIORITY||Estimate Difference|-8.74|||<|0.001|TWO_SIDED|95.0|-12.04|-5.32|||Mixed Models Analysis|||||-5.32|-12.04|<0.001
71006599|NCT04657003|141521170|SUPERIORITY||Estimate Difference|-23.61|||<|0.001|TWO_SIDED|95.0|-28.62|-18.24|||Mixed Models Analysis|||||-18.24|-28.62|<0.001
71006600|NCT04657003|141521171|SUPERIORITY||LSMean Mean Difference (Net)|-6.2|||<|0.001|TWO_SIDED|95.0|-8.0|-4.4|||Mixed Models Analysis|||||-4.4|-8.0|<0.001
71006601|NCT04657003|141521172|SUPERIORITY||LSMean Mean Difference (Net)|-2.4|||<|0.001|TWO_SIDED|95.0|-3.5|-1.3|||Mixed Models Analysis|||||-1.3|-3.5|<0.001
71006602|NCT04657003|141521173|SUPERIORITY||Estimate Difference|-17.6|||<|0.001|TWO_SIDED|95.0|-25.5|-8.9|||Mixed Models Analysis|||||-8.9|-25.5|<0.001
71006603|NCT04657003|141521173|SUPERIORITY||Estimate Difference|-30.2|||<|0.001|TWO_SIDED|95.0|-37.0|-22.7|||Mixed Models Analysis|||||-22.7|-37.0|<0.001
71006604|NCT04657003|141521174|SUPERIORITY||LSMean Mean Difference (Net)|1.8||||0.001|TWO_SIDED|95.0|0.7|2.9|||ANCOVA|||||2.9|0.7|0.001
71006605|NCT04657003|141521174|SUPERIORITY||LSMean Mean Difference (Net)|2.3|||<|0.001|TWO_SIDED|95.0|1.1|3.4|||ANCOVA|||||3.4|1.1|<0.001
71006606|NCT04657003|141521175|SUPERIORITY||LSMean Difference (Net)|6.9|||<|0.001|TWO_SIDED|95.0|4.1|9.7|||ANCOVA|||||9.7|4.1|<0.001
71006607|NCT04657003|141521175|SUPERIORITY||LSMean Difference (Net)|7.8|||<|0.001|TWO_SIDED|95.0|5.0|10.7|||ANCOVA|||||10.7|5.0|<0.001
71006608|NCT00935766|141521177|SUPERIORITY_OR_OTHER|||||||0.21|||||||Mixed Models Analysis|||||||0.21
71006609|NCT00935766|141521178|SUPERIORITY_OR_OTHER|||||||0.08|||||||Mixed Models Analysis|||||||0.08
71101932|NCT03715829|141711674|SUPERIORITY||Least Squares Mean Difference (Net)|-23.2|STANDARD_ERROR_OF_MEAN|5.63|<|0.0001|TWO_SIDED|90.0|-32.53|-13.93||Hochberg's step-up procedure was conducted to compare ritlecitinib 100mg - 50mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. Hochberg adjusted p-value is presented here.|ANCOVA|||||-13.93|-32.53|<0.0001
71101933|NCT03715829|141711674|SUPERIORITY||Least Squares Mean Difference (Net)|-20.6|STANDARD_ERROR_OF_MEAN|5.84||0.0003|TWO_SIDED|90.0|-30.23|-10.93||Hochberg's step-up procedure was conducted to compare the ritlecitinib 50 mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. Hochberg adjusted p-value is presented here.|ANCOVA|||||-10.93|-30.23|0.0003
71101934|NCT03715829|141711674|SUPERIORITY||Least Squares Mean Difference (Net)|-16.7|STANDARD_ERROR_OF_MEAN|6.71||0.0068|TWO_SIDED|90.0|-27.77|-5.61||Hochberg's step-up procedure was conducted to compare the ritlecitinib 30 mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. One-sided unadjusted p-value is presented here.|ANCOVA|||||-5.61|-27.77|0.0068
71101935|NCT03715829|141711674|SUPERIORITY||Least Squares Mean Difference (Net)|-5.1|STANDARD_ERROR_OF_MEAN|6.03||0.2015|TWO_SIDED|90.0|-15.02|4.91||Hochberg's step-up procedure was conducted to compare the ritlecitinib 10 mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. One-sided unadjusted p-value is presented here.|ANCOVA|||||4.91|-15.02|0.2015
71101936|NCT03253627|141711729|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||baseline||||0.460
71101937|NCT03253627|141711729|SUPERIORITY|||||||0.896|||||||t-test, 2 sided|||3 months||||0.896
71101938|NCT03253627|141711730|SUPERIORITY|||||||0.374|||||||t-test, 2 sided|||baseline||||0.374
71101939|NCT03253627|141711730|SUPERIORITY|||||||0.236|||||||t-test, 2 sided|||6 months||||0.236
71006610|NCT00935766|141521179|SUPERIORITY_OR_OTHER|||||||0.36|||||||Mixed Models Analysis|||||||0.36
71006611|NCT03347279|141521202|SUPERIORITY||Rate Ratio|0.44|||<|0.001|TWO_SIDED|95.0|0.37|0.53|||Negative Binomial|||||0.53|0.37|<0.001
71006612|NCT03347279|141521203|SUPERIORITY||Rate Ratio|0.59|||<|0.001|TWO_SIDED|95.0|0.46|0.75|||Negative Binomial|||||0.75|0.46|<0.001
71006613|NCT03347279|141521204|SUPERIORITY||Least Squares (LS) Mean Difference|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.18|||Mixed Models Analysis|||||0.18|0.08|<0.001
71006614|NCT03347279|141521205|SUPERIORITY||LS Means Difference|0.33|||<|0.001|TWO_SIDED|95.0|0.2|0.47|||Mixed Models Analysis|||||0.47|0.2|<0.001
71006615|NCT03347279|141521206|SUPERIORITY||LS Means Difference|-0.33|||<|0.001|TWO_SIDED|95.0|-0.46|-0.2|||Mixed Models Analysis|||||-0.2|-0.46|<0.001
71006616|NCT03347279|141521207|SUPERIORITY||LS Means Difference|-0.11||||0.004|TWO_SIDED|95.0|-0.19|-0.04|||Mixed Models Analysis|||||-0.04|-0.19|0.004
71101940|NCT03253627|141711731|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||baseline||||0.180
71101941|NCT03253627|141711731|SUPERIORITY|||||||0.822|||||||t-test, 2 sided|||6 months||||0.822
71101942|NCT03253627|141711732|SUPERIORITY|||||||0.715|||||||t-test, 2 sided|||baseline||||.715
71101943|NCT03253627|141711732|SUPERIORITY|||||||0.861|||||||t-test, 2 sided|||3 months||||0.861
71101944|NCT03253627|141711732|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||6 months||||.790
71101945|NCT03253627|141711733|SUPERIORITY|||||||0.452|||||||t-test, 2 sided|||baseline||||0.452
71101946|NCT03253627|141711733|SUPERIORITY|||||||0.253|||||||t-test, 2 sided|||3 months||||0.253
71101947|NCT03253627|141711733|SUPERIORITY|||||||0.469|||||||t-test, 2 sided|||6 months||||0.469
71101948|NCT03253627|141711734|SUPERIORITY|||||||0.628|||||||t-test, 2 sided|||baseline||||0.628
71101949|NCT03253627|141711734|SUPERIORITY|||||||0.345|||||||t-test, 2 sided|||3 months||||0.345
71101950|NCT03253627|141711734|SUPERIORITY|||||||0.384|||||||t-test, 2 sided|||6 months||||0.384
71101951|NCT03253627|141711735|SUPERIORITY|||||||0.398|||||||t-test, 2 sided|||baseline||||.398
71101952|NCT03253627|141711735|SUPERIORITY|||||||0.811|||||||t-test, 2 sided|||3 months||||0.811
71101953|NCT03253627|141711735|SUPERIORITY|||||||0.027|||||||t-test, 2 sided|||6 months||||0.027
71006617|NCT02530281|141521259|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71006618|NCT02530281|141521260|OTHER||||||=|0.065|||||||ANCOVA|Ranked ANCOVA||||||=0.065
71006619|NCT02530281|141521261|OTHER||||||=|0.065|||||||ANCOVA|Ranked ANCOVA||||||=0.065
71006620|NCT02530281|141521262|OTHER||||||=|0.001|||||||ANCOVA|Ranked ANCOVA||||||=0.001
71101954|NCT01916226|141711746|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|-0.3||0.278|TWO_SIDED|95.0|-0.7|0.2||Estimating the standard deviation of CFB in rTNSS over 2 weeks to be approximately 2.6, a two-sample t-test with α=0.05 suggests that a sample size of 144 participants per arm would provide 90% power to show a difference of 1.0 between treatments.|ANCOVA|||||0.2|-0.7|0.278
71101955|NCT03163667|141711753|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.07905|TWO_SIDED|95.0|0.34|1.2||One-sided p-value comparing the treatment groups was based on a stratified log-rank test with alternative hypothesis of survival functions being not equal.|Log Rank||Hazard ratio comparing treatment groups (experimental over control) is based on a Cox proportional hazards model. A hazard ratio \< 1 favors CB-839+Everolimus (CBE), and a hazard ratio \> 1 favors Placebo+Everolimus (PboE).|Stratified analysis. Stratification factors were Memorial Sloan Kettering Cancer Center (MSKCC) Prognostic Risk (favorable versus intermediate/poor risk) and number of prior therapies with a tyrosine kinase inhibitor (TKI; 1 versus \> 1). Due to stratification cells having \< 10 events, TKI stratification factor was removed for analysis.||1.20|0.34|0.07905
71101956|NCT03163667|141711753|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.1184|TWO_SIDED|95.0|0.37|1.28||One-sided p-value comparing the treatment groups was based on an unstratified log-rank test with alternative hypothesis of survival functions being not equal.|Log Rank||Hazard ratio comparing treatment groups (experimental over control) is based on a Cox proportional hazards model. A hazard ratio \< 1 favors CBE, and a hazard ratio \> 1 favors PboE.|Unstratified analysis||1.28|0.37|0.1184
71006621|NCT02530281|141521263|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71006622|NCT02530281|141521264|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71006623|NCT00535236|141521268|OTHER||||||<|0.001||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the GMFR in the vaccine recipients being \>1.0|Single longitudinal regression model|Adjusted for prevaccination values||||||<0.001
71006624|NCT00535236|141521268|OTHER|||||||0.003||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the GMFR in the vaccine recipients being \>1.0|Single longitudinal regression model|Adjusted for prevaccination values||||||0.003
71006625|NCT00535236|141521268|OTHER|||||||0.017||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the GMFR in the vaccine recipients being \>1.0|Single longitudinal regression model|Adjusted for prevaccination values||||||0.017
71006626|NCT00535236|141521269|OTHER||||||<|0.001||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the GMFR in the vaccine recipients being \>1.0|Single longitudinal regression model|Adjustied for prevaccination values||||||<0.001
71006627|NCT00535236|141521269|OTHER|||||||0.004||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the geometric mean fold rise (GMFR) in the vaccine recipients being \>1.0|Single longitudinal regression model|Adjusted for prevaccination values||||||0.004
71006628|NCT00535236|141521269|OTHER|||||||0.026||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the geometric mean fold rise (GMFR) in the vaccine recipients being \>1.0|Single longitudinal regression model|Adjusted for prevaccination values||||||0.026
71006629|NCT00535236|141521270|OTHER||Difference in Percentages|12.5|||||TWO_SIDED|95.0|-21.7|35.3|||||V212 minus placebo = Difference|||35.3|-21.7|
71006630|NCT00535236|141521270|OTHER||Difference in Percentages|10.0|||||TWO_SIDED|95.0|-15.1|42.9|||||V212 minus placebo = Difference|||42.9|-15.1|
71006631|NCT00535236|141521270|OTHER||Difference in Percentages|1.8|||||TWO_SIDED|95.0|-20.4|15.7|||||V212 minus placebo = Difference|||15.7|-20.4|
71006632|NCT00535236|141521270|OTHER||Difference in Percentages|14.4|||||TWO_SIDED|95.0|-6.5|27.6|||||V212 minus placebo = Difference|||27.6|-6.5|
71101957|NCT03163667|141711754|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.4801|TWO_SIDED|95.0|0.42|1.5||P-value comparing the treatment groups is based on a stratified log-rank test with alternative hypothesis of survival functions being not equal.|Log Rank||Hazard ratio based on a Cox proportional hazards model. A hazard ratio \< 1 favors CBE, and a hazard ratio \> 1 favors PboE.|Stratified analysis: Stratification factors are MSKCC Prognostic Risk (favorable vs intermediate/poor risk) and number of prior therapies with a TKI (1 vs \> 1). Due to stratification cells having \< 10 events, TKI stratification factor was removed for analysis.||1.50|0.42|0.4801
71101958|NCT03163667|141711754|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.5603|TWO_SIDED|95.0|0.44|1.56||P-value comparing the treatment groups is based on an unstratified log-rank test with alternative hypothesis of survival functions being not equal.|Log Rank||Hazard ratio comparing treatment groups (experimental over control) is based on a Cox proportional hazards model. A hazard ratio \< 1 favors CBE, and a hazard ratio \> 1 favors PboE.|Unstratified analysis||1.56|0.44|0.5603
71101959|NCT04910165|141711765|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Wilcoxon (Mann-Whitney)|||||||<0.05
71006633|NCT00535236|141521270|OTHER||Difference in Percentages|3.3|||||TWO_SIDED|95.0|-18.1|17.0|||||V212 minus placebo = Difference|||17.0|-18.1|
71006634|NCT00535236|141521271|OTHER||Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-31.7|16.5|||Asymptotic method||V212 minus placebo = Difference|||16.5|-31.7|>0.999
71006635|NCT00535236|141521271|OTHER||Difference in Percentages|10.0||||0.302|TWO_SIDED|95.0|-18.8|23.2|||Asymptotic method||V212 minus placebo = Difference|||23.2|-18.8|0.302
71006636|NCT00535236|141521271|OTHER||Difference in Percentages|31.6||||0.009|TWO_SIDED|95.0|9.7|46.2|||Asymptotic method||V212 minus placebo = Difference|||46.2|9.7|0.009
71006637|NCT00535236|141521271|OTHER||Difference in Percentages|22.6||||0.041|TWO_SIDED|95.0|1.3|36.6|||Asymptotic method||V212 minus placebo = Difference|||36.6|1.3|0.041
71006638|NCT00535236|141521271|OTHER||Difference in Percentages|-11.7||||0.064|TWO_SIDED|95.0|-33.2|0.6|||Asymptotic method||V212 minus placebo = Difference|||0.6|-33.2|0.064
71006639|NCT00535236|141521272|OTHER||Difference in Percentages|-5.0||||0.556|TWO_SIDED|95.0|-36.3|9.5|||Asymptotic method||V212 minus placebo = Difference|||9.5|-36.3|0.556
71006640|NCT00535236|141521272|OTHER||Difference in Percentages|2.5||||0.617|TWO_SIDED|95.0|-25.8|13.0|||Asymptotic method||V212 minus placebo = Difference|||13.0|-25.8|0.617
71006641|NCT00535236|141521272|OTHER||Difference in Percentages|3.5||||0.411|TWO_SIDED|95.0|-13.7|12.0|||Asymptotic method||V212 minus placebo = Difference|||12.0|-13.7|0.411
71006642|NCT00535236|141521272|OTHER||Difference in Percentages|4.9||||0.328|TWO_SIDED|95.0|-12.3|13.6|||Asymptotic method||V212 minus placebo = Difference|||13.6|-12.3|0.328
71006643|NCT00535236|141521272|OTHER||Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-19.2|10.0|||Asymptotic method||V212 minus placebo = Difference|||10.0|-19.2|>0.999
71006644|NCT00535236|141521273|OTHER||Difference in Percentages|10.5||||0.552|TWO_SIDED|95.0|-21.3|41.8|||Asymptotic method||V212 minus placebo = Difference|||41.8|-21.3|0.552
71006645|NCT00535236|141521273|OTHER||Difference in Percentages|6.7||||0.696|TWO_SIDED|95.0|-22.5|39.4|||Asymptotic method||V212 minus placebo = Difference|||39.4|-22.5|0.696
71006646|NCT00535236|141521273|OTHER||Difference in Percentages|7.5||||0.221|TWO_SIDED|95.0|-9.8|18.0|||Asymptotic method||V212 minus placebo = Difference|||18.0|-9.8|0.221
71006647|NCT00535236|141521273|OTHER||Difference in Percentages|6.8||||0.402|TWO_SIDED|95.0|-13.7|19.1|||Asymptotic method||V212 minus placebo = Difference|||19.1|-13.7|0.402
71006648|NCT00535236|141521273|OTHER||Difference in Percentages|3.8||||0.679|TWO_SIDED|95.0|-18.5|18.2|||Asymptotic method||V212 minus placebo = Difference|||18.2|-18.5|0.679
71006649|NCT02200510|141521330|EQUIVALENCE|Because this was a pilot study, the goal was to detect effects sizes for a larger R01 or R21.|Mean Difference (Final Values)|0.33||||0.575|TWO_SIDED||||||ANOVA|||||||0.575
71006650|NCT02200510|141521330|EQUIVALENCE|Because this was a pilot study, the goal was to detect effects sizes for a larger R01 or R21.|Mean Difference (Final Values)|0.138||||0.721|TWO_SIDED||||||ANOVA|||||||0.721
71101960|NCT04910165|141711766|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Wilcoxon (Mann-Whitney)|||||||<0.05
71101961|NCT04910165|141711767|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Wilcoxon (Mann-Whitney)|||||||<0.05
71101962|NCT04910165|141711768|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Wilcoxon (Mann-Whitney)|||||||<0.05
71101963|NCT04910165|141711769|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Wilcoxon (Mann-Whitney)|||||||<0.05
71101964|NCT04910165|141711770|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Fisher Exact|||||||<0.05
71101965|NCT04910165|141711771|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Fisher Exact|||||||<0.05
71101966|NCT01813357|141711783|SUPERIORITY||Mean Difference (Final Values)|0.002||||0.684|TWO_SIDED||||||Mixed Models Analysis|||||||0.684
71006651|NCT00290355|141521331|OTHER||Hazard Ratio (HR)|0.74||||0.256|TWO_SIDED|95.0|0.44|1.24||Two-sided p value from Cox regression model adjusted for covariate(s) node/squam/stage to test the null hypothesis was: the distribution of time to recurrences was the same in each group (H0 = \[HR=1\]).|Regression, Cox|The p value by log rank test was 0.1995. Criterion for evaluation of the objective: one sided p-value \< 10%||Hazard ratio of GSK 249553 study product.||1.24|0.44|0.256
71006652|NCT03502941|141521361|SUPERIORITY||||||<|0.05||||||P value was calculated.|t-test, 2 sided|||||||<0.05
71006653|NCT03502941|141521362|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71006654|NCT01072500|141521381|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.03|TWO_SIDED|95.0|0.69|0.98|||Regression, Cox|To compare interventions, we used a likelihood ratio test from a Cox regression model, stratified by field center and sex.||||0.98|0.69|0.03
71101967|NCT03773562|141711785|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Responders vs Non-responders||||0.04
71101968|NCT03773562|141711787|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||Responders vs Non-Responders||||0.002
71101969|NCT03773562|141711788|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||Responders vs Non-responders||||0.01
71101970|NCT03773562|141711790|SUPERIORITY|||||||0.0003|||||||t-test, 2 sided|||Responder vs non-responder||||0.0003
71101971|NCT03773562|141711791|SUPERIORITY|||||||0.0003|||||||t-test, 2 sided|||Responder vs non-responder||||0.0003
71101972|NCT03773562|141711792|SUPERIORITY|||||||0.0003|||||||t-test, 2 sided|||Responder vs non-responder||||0.0003
71101973|NCT03773562|141711793|SUPERIORITY|||||||0.0033|||||||t-test, 2 sided|||Responder vs non-responder||||0.0033
71006655|NCT01072500|141521382|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.006|TWO_SIDED|95.0|0.57|0.91|||Regression, Cox|||||0.91|0.57|0.006
71006656|NCT02061540|141521415|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.841|STANDARD_ERROR_OF_MEAN|6.0373||0.0043|TWO_SIDED|95.0|-27.251|-2.432|||Wilcoxon's signed rank test|||Analysis was performed to compare baseline and endpoint data.||-2.432|-27.251|0.0043
71006657|NCT01642004|141521436|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.59||||0.0002|TWO_SIDED|96.85|0.43|0.81||Stratified by region (US/Canada, Rest Of World (ROW), Europe) and prior treatment regimen (Paclitaxel, Another agent) as entered in the Interactive Voice Response System (IVRS).|Log Rank||Stratified Cox proportional hazard model. HR = Nivolumab over Docetaxel|||0.81|0.43|0.0002
71006658|NCT00598806|141521450|SUPERIORITY||Odds Ratio (OR)|0.76||||0.1094|TWO_SIDED|95.0|0.55|1.06|||Cochran-Mantel-Haenszel|||||1.06|0.55|0.1094
71006659|NCT00598806|141521451|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.1038|TWO_SIDED|95.0|0.63|1.04|||Log Rank|||||1.04|0.63|0.1038
71101974|NCT03773562|141711794|SUPERIORITY|||||||0.0041|||||||t-test, 2 sided|||Responder vs non-responder||||0.0041
71101975|NCT03773562|141711795|SUPERIORITY|||||||0.0046|||||||t-test, 2 sided|||Responder vs non-responder||||0.0046
71101976|NCT01854762|141711796|OTHER||Odds Ratio (OR)|3.1|||<|0.01|TWO_SIDED|95.0|1.3|7.4|||Fisher Exact||||Kaplan-Meier estimates for the proportion of patients without virological failure by weeks 2, 4 and 6, and at delivery, using treatment-related discontinuation equal failure analysis|7.4|1.3|<0.01
71101977|NCT04806373|141711809|OTHER|||||||0.863|||||||Fisher Exact|||||||0.863
71101978|NCT04806373|141711810|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||Difference in pleural drainage volume day 1 post-TSP||||0.005
71101979|NCT04806373|141711811|OTHER|||||||0.891|||||||Wilcoxon (Mann-Whitney)|||Borg dyspnea scale day 3 post-TSP||||0.891
71101980|NCT04806373|141711812|OTHER|||||||0.899|||||||Wilcoxon (Mann-Whitney)|||Pain score at day 3 post-TSP||||0.899
71101981|NCT04806373|141711813|OTHER|||||||0.809|||||||Fisher Exact|||||||0.809
71101982|NCT04806373|141711814|OTHER|||||||0.946|||||||Wilcoxon (Mann-Whitney)|||||||0.946
71101983|NCT04806373|141711815|OTHER|||||||0.808|||||||Wilcoxon (Mann-Whitney)|||||||0.808
71101984|NCT04806373|141711816|OTHER|||||||0.662|||||||Fisher Exact|||||||0.662
71101985|NCT04806373|141711817|OTHER|||||||0.714|||||||t-test, 2 sided|||||||0.714
71101986|NCT04806373|141711818|OTHER|||||||1|||||||Fisher Exact|||||||1.0
71101987|NCT00373360|141711864|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||1.000
71101988|NCT00373360|141711865|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.008
71101989|NCT00373360|141711866|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||1.000
71101990|NCT00373360|141711867|SUPERIORITY_OR_OTHER|||||||0.531||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.531
71101991|NCT00373360|141711868|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||1.000
71101992|NCT00373360|141711869|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.500
71101993|NCT00373360|141711870|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||1.000
71045151|NCT02709486|141599377|SUPERIORITY||Least Square Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.35|-0.14|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.14|-0.35|<.0001
71045152|NCT02709486|141599377|SUPERIORITY||Least Square Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.43|-0.22|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.22|-0.43|<.0001
71045153|NCT02709486|141599377|SUPERIORITY||Least Square Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.0029|TWO_SIDED|95.0|-0.28|-0.06|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.06|-0.28|0.0029
71045154|NCT02709486|141599377|SUPERIORITY||Least Square Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.37|-0.15|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.15|-0.37|<.0001
71045155|NCT02709486|141599377|SUPERIORITY||Least Square Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.4|-0.17|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.17|-0.40|<.0001
71045156|NCT02709486|141599377|SUPERIORITY||Least Square Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.43|-0.2|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.20|-0.43|<.0001
71006660|NCT02607865|141521491|NON_INFERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand). A value of 0.3% (the non-inferiority margin) was added to imputed values at week 26 for the oral semaglutide treatment arm only.|Mean treatment difference|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.4||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|Pattern mixture model||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.4|-0.6|< 0.0001
71006661|NCT02607865|141521491|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.4||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.4|-0.6|< 0.0001
71045157|NCT02709486|141599377|SUPERIORITY||Least Square Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.06||0.0352|TWO_SIDED|95.0|-0.26|-0.01|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.01|-0.26|0.0352
71045158|NCT02709486|141599377|SUPERIORITY||Least Square Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.37|-0.13|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.13|-0.37|<.0001
71045159|NCT02709486|141599379|SUPERIORITY||Odds Ratio (OR)|2.23|||<|0.0001|TWO_SIDED|95.0|1.59|3.14|||Regression, Logistic|||Week 2: Odds ratio and 95 percent (%) confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.14|1.59|<.0001
71045160|NCT02709486|141599379|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0085|TWO_SIDED|95.0|1.12|2.18|||Regression, Logistic|||Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.18|1.12|0.0085
71101994|NCT00373360|141711871|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||1.000
71101995|NCT00373360|141711872|SUPERIORITY_OR_OTHER|||||||0||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0
71101996|NCT00373360|141711873|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||1.000
71045161|NCT02709486|141599379|SUPERIORITY||Odds Ratio (OR)|2.71|||<|0.0001|TWO_SIDED|95.0|1.89|3.88|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.88|1.89|<.0001
71045162|NCT02709486|141599379|SUPERIORITY||Odds Ratio (OR)|2.31|||<|0.0001|TWO_SIDED|95.0|1.62|3.28|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.28|1.62|<.0001
71045163|NCT02709486|141599379|SUPERIORITY||Odds Ratio (OR)|1.91||||0.0005|TWO_SIDED|95.0|1.33|2.75|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.75|1.33|0.0005
71045164|NCT02709486|141599379|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0005|TWO_SIDED|95.0|1.32|2.73|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.73|1.32|0.0005
71045165|NCT02709486|141599379|SUPERIORITY||Odds Ratio (OR)|1.94||||0.0009|TWO_SIDED|95.0|1.31|2.86|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.86|1.31|0.0009
71045166|NCT02709486|141599379|SUPERIORITY||Odds Ratio (OR)|1.95||||0.0008|TWO_SIDED|95.0|1.32|2.89|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.89|1.32|0.0008
71045167|NCT02709486|141599379|SUPERIORITY||Odds Ratio (OR)|2.06||||0.0002|TWO_SIDED|95.0|1.41|3.01|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.01|1.41|0.0002
71045168|NCT02709486|141599379|SUPERIORITY||Odds Ratio (OR)|1.78||||0.0022|TWO_SIDED|95.0|1.23|2.57|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment||2.57|1.23|0.0022
71045169|NCT02709486|141599379|SUPERIORITY||Odds Ratio (OR)|1.75||||0.0032|TWO_SIDED|95.0|1.21|2.54|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment||2.54|1.21|0.0032
71045170|NCT02709486|141599379|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0013|TWO_SIDED|95.0|1.27|2.69|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment||2.69|1.27|0.0013
71101997|NCT00373360|141711874|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.031
71045171|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0006|TWO_SIDED|95.0|1.3|2.59|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.59|1.30|0.0006
71045172|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|1.53||||0.016|TWO_SIDED|95.0|1.08|2.16|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.16|1.08|0.0160
71101998|NCT00373360|141711875|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.031
71101999|NCT00373360|141711876|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.004
71102000|NCT00373360|141711877|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.063
71102001|NCT00373360|141711878|SUPERIORITY_OR_OTHER|||||||0.203||95.0|||||Wilcoxon signed rank test|||Change Between Baseline and Week 8||||0.203
71102002|NCT00373360|141711882|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||0.250
71102003|NCT00373360|141711883|SUPERIORITY_OR_OTHER|||||||0.207||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.207
71102004|NCT00373360|141711884|SUPERIORITY_OR_OTHER|||||||0.297||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.297
71102005|NCT00373360|141711885|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.004
71102006|NCT00787800|141711889|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Log Rank|||||||1.0
71102007|NCT00787800|141711891|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.050
71006662|NCT02607865|141521491|NON_INFERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand). A value of 0.3% (the non-inferiority margin) was added to imputed values at week 26 for the oral semaglutide treatment arm only.|Mean treatment difference|-0.2|||<|0.0001|TWO_SIDED|95.0|-0.4|-0.1||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|Pattern mixture model||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.1|-0.4|< 0.0001
71102008|NCT00787800|141711893|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71102009|NCT00913835|141711917|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.054||||0.8049|TWO_SIDED|90.0|0.751|1.478|||Log Rank|Stratified by prior platinum treatment, platinum-refractory versus platinum-resistance reaction.||||1.478|0.751|0.8049
71102010|NCT00913835|141711918|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.115||||0.6346|TWO_SIDED|90.0|0.768|1.618|||Log Rank|Stratified by prior platinum treatment, platinum-refractory versus platinum-resistance reaction.||||1.618|0.768|0.6346
71102011|NCT00913835|141711919|SUPERIORITY_OR_OTHER_LEGACY|||||||0.619|TWO_SIDED||||||Fisher Exact|||||||0.6190
71102012|NCT01308788|141711930|SUPERIORITY_OR_OTHER|||||||0.4414||95.0|||||ANCOVA|||||||.4414
71102013|NCT01308788|141711931|SUPERIORITY_OR_OTHER|||||||0.782||95.0|||||ANCOVA|||||||.7820
71006663|NCT02607865|141521491|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.3|||<|0.0001|TWO_SIDED|95.0|-0.4|-0.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.1|-0.4|< 0.0001
71008667|NCT02055976|141525240|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.0629|STANDARD_ERROR_OF_MEAN|1.032||0.002|TWO_SIDED|95.0|-5.1132|-1.0125|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.0125|-5.1132|0.002
71008668|NCT02055976|141525240|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.6209|STANDARD_ERROR_OF_MEAN|1.0367|<|0.001|TWO_SIDED|95.0|-5.6804|-1.5614|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.5614|-5.6804|<0.001
71008669|NCT02055976|141525240|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.1778|STANDARD_ERROR_OF_MEAN|1.0269|<|0.001|TWO_SIDED|95.0|-6.2184|-2.1372|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-2.1372|-6.2184|<0.001
71008670|NCT02055976|141525240|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.2914|STANDARD_ERROR_OF_MEAN|1.2954||0.006|TWO_SIDED|95.0|-5.8649|-0.7178|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.7178|-5.8649|0.006
71008671|NCT02055976|141525240|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.3569|STANDARD_ERROR_OF_MEAN|1.3157|<|0.001|TWO_SIDED|95.0|-8.9706|-3.7432|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-3.7432|-8.9706|<0.001
71102014|NCT01308788|141711932|SUPERIORITY_OR_OTHER|||||||0.5496||95.0|||||ANCOVA|||||||.5496
71102015|NCT01308788|141711933|SUPERIORITY_OR_OTHER|||||||0.293||95.0|||||ANCOVA|||||||.2930
71102016|NCT01308788|141711934|SUPERIORITY_OR_OTHER|||||||0.5058||95.0|||||ANCOVA|||||||.5058
71102017|NCT01308788|141711935|SUPERIORITY_OR_OTHER|||||||0.6156||95.0|||||ANCOVA|||||||.6156
71102018|NCT01308788|141711936|SUPERIORITY_OR_OTHER|||||||0.5443||95.0|||||ANCOVA|||||||.5443
71102019|NCT01308788|141711937|SUPERIORITY_OR_OTHER|||||||0.7847||95.0|||||ANCOVA|||||||.7847
71008672|NCT02055976|141525240|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.3962|STANDARD_ERROR_OF_MEAN|1.3233|<|0.001|TWO_SIDED|95.0|-9.0247|-3.7677|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-3.7677|-9.0247|<0.001
71102020|NCT01308788|141711938|SUPERIORITY_OR_OTHER|||||||0.1331||95.0|||||ANCOVA|||||||.1331
71102021|NCT01308788|141711939|SUPERIORITY_OR_OTHER|||||||0.5431||95.0|||||ANCOVA|||||||.5431
71102022|NCT01308788|141711940|SUPERIORITY_OR_OTHER|||||||0.0684||95.0|||||ANCOVA|||||||.0684
71102023|NCT01308788|141711941|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||ANCOVA|||||||.2500
71102024|NCT01308788|141711942|SUPERIORITY_OR_OTHER|||||||0.6896||95.0|||||ANCOVA|||||||.6896
70925410|NCT03232138|141344226|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. TUNEL all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.552||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||Weak-intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.552
70925411|NCT03232138|141344226|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. TUNEL all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.205||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||Moderate-intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.205
70925412|NCT03232138|141344226|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. TUNEL all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.295||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||Strong-intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.295
71006664|NCT02607865|141521491|NON_INFERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand). A value of 0.3% (the non-inferiority margin) was added to imputed values at week 26 for the oral semaglutide treatment arm only.|Mean treatment difference|0.2|||=|0.0856|TWO_SIDED|95.0|0.1|0.3||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|Pattern mixture model||Oral semaglutide 3 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.3|0.1|= 0.0856
71006665|NCT02607865|141521491|SUPERIORITY|This hypothesis was not controlled for multiplicity, since the non-inferiority test of change in HbA1c for oral semaglutide 3 mg versus sitagliptin 100 mg could not be confirmed. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|0.2|||=|0.008|TWO_SIDED|95.0|0.0|0.3||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 3 mg - Sitagliptin 100 mg. If the mean treatment difference is non-negative, the superiority hypothesis of oral semaglutide 3 mg vs sitagliptin 100 mg will never be confirmed irrespective of the observed two-sided p-value.|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.3|0.0|= 0.0080
71008673|NCT02055976|141525240|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.9228|STANDARD_ERROR_OF_MEAN|0.9199|<|0.001|TWO_SIDED|95.0|-5.7506|-2.095|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-2.0950|-5.7506|<0.001
71008674|NCT02055976|141525240|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.7094|STANDARD_ERROR_OF_MEAN|0.9244|<|0.001|TWO_SIDED|95.0|-6.5459|-2.8729|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-2.8729|-6.5459|<0.001
71008675|NCT02055976|141525240|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.4374|STANDARD_ERROR_OF_MEAN|0.9187|<|0.001|TWO_SIDED|95.0|-6.263|-2.6118|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-2.6118|-6.2630|<0.001
71008676|NCT02055976|141525241|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.4492|STANDARD_ERROR_OF_MEAN|10.2401||0.004|TWO_SIDED|95.0|-47.7872|-7.1112|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-7.1112|-47.7872|0.004
71008677|NCT02055976|141525241|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.5908|STANDARD_ERROR_OF_MEAN|10.4568|<|0.001|TWO_SIDED|95.0|-61.3577|-19.824|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-19.8240|-61.3577|<0.001
71045173|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|2.03||||0.0008|TWO_SIDED|95.0|1.34|3.07|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.07|1.34|0.0008
71045174|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|1.16||||0.5118|TWO_SIDED|95.0|0.75|1.8|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.80|0.75|0.5118
71045175|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|2.45||||0.0093|TWO_SIDED|95.0|1.25|4.81|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.81|1.25|0.0093
71045176|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|1.46||||0.3017|TWO_SIDED|95.0|0.71|3.01|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.01|0.71|0.3017
71045177|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|2.4||||0.216|TWO_SIDED|95.0|0.6|9.58|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||9.58|0.60|0.2160
71102025|NCT01308788|141711943|SUPERIORITY_OR_OTHER|||||||0.7965||95.0|||||ANCOVA|||||||.7965
71102026|NCT02414841|141711944|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.932|TWO_SIDED|95.0|0.67|1.39|||Log Rank|Weighted|Performed as sensitivity analysis|||1.39|0.67|0.932
71008678|NCT02055976|141525241|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.163|STANDARD_ERROR_OF_MEAN|10.5402||0.006|TWO_SIDED|95.0|-48.0927|-6.2332|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-6.2332|-48.0927|0.006
71008679|NCT02055976|141525241|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-24.1677|STANDARD_ERROR_OF_MEAN|8.8755||0.004|TWO_SIDED|95.0|-41.8023|-6.5332|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-6.5332|-41.8023|0.004
71045178|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|1.33||||0.7174|TWO_SIDED|95.0|0.29|6.08|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||6.08|0.29|0.7174
71102027|NCT02414841|141711945|SUPERIORITY|||||||0.328|||||||Chi-squared|||||||0.328
71008680|NCT02055976|141525241|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-19.2255|STANDARD_ERROR_OF_MEAN|8.9203||0.017|TWO_SIDED|95.0|-36.9471|-1.5038|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.5038|-36.9471|0.017
71008681|NCT02055976|141525241|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-26.5155|STANDARD_ERROR_OF_MEAN|8.8387||0.002|TWO_SIDED|95.0|-44.0795|-8.9515|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-8.9515|-44.0795|0.002
71008682|NCT02055976|141525241|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-18.3898|STANDARD_ERROR_OF_MEAN|5.1768|<|0.001|TWO_SIDED|95.0|-28.6698|-8.1097|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-8.1097|-28.6698|<0.001
71008683|NCT02055976|141525241|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-36.7882|STANDARD_ERROR_OF_MEAN|5.264|<|0.001|TWO_SIDED|95.0|-47.2423|-26.3341|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-26.3341|-47.2423|<0.001
70925413|NCT03232138|141344227|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) baseline positive cells. Caspase-3 positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.295||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||All positive nuclei. Mean (95%CI) at baseline.||||0.295
71006666|NCT02607865|141521491|NON_INFERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.5||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|MMRM||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.5|-0.7|<0.0001
71006667|NCT02607865|141521491|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.5||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.5|-0.7|<0.0001
71006668|NCT02607865|141521491|NON_INFERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.3|||<|0.0001|TWO_SIDED|95.0|-0.4|-0.2||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|MMRM||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.2|-0.4|<0.0001
71006669|NCT02607865|141521491|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.3|||<|0.0001|TWO_SIDED|95.0|-0.4|-0.2||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.2|-0.4|<0.0001
71006670|NCT02607865|141521491|NON_INFERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|0.2|||=|0.3851|TWO_SIDED|95.0|0.1|0.4||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|MMRM||Oral semaglutide 3 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||0.4|0.1|=0.3851
71006671|NCT02607865|141521491|OTHER|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|0.2|||<|0.0001|TWO_SIDED|95.0|0.1|0.4||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 3 mg - Sitagliptin 100 mg. If the mean treatment difference is non-negative, the superiority hypothesis of oral semaglutide 3 mg vs sitagliptin 100 mg will never be confirmed irrespective of the observed two-sided p-value.|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||0.4|0.1|<0.0001
71008684|NCT02055976|141525241|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-36.8453|STANDARD_ERROR_OF_MEAN|5.3084|<|0.001|TWO_SIDED|95.0|-47.3864|-26.3041|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-26.3041|-47.3864|<0.001
71045179|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|2.04|||<|0.0001|TWO_SIDED|95.0|1.45|2.87|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.87|1.45|<.0001
71045180|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|1.81||||0.0006|TWO_SIDED|95.0|1.29|2.54|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.54|1.29|0.0006
71102028|NCT02657356|141711969|SUPERIORITY||LS Mean difference (Net)|-12.86|STANDARD_ERROR_OF_MEAN|7.012||0.0683|TWO_SIDED|95.0|-26.69|0.98|||Mixed Models Analysis|Covariates: screening 6MWT, day 1 hemoglobin, treatment grp, # of PAH medications, time, interactions btwn treatment \& time, and screening 6MWT \& time|Difference is bardoxolone methyl - placebo|||0.98|-26.69|0.0683
71102029|NCT02657356|141711970|SUPERIORITY||Hazard Ratio (HR)|1.984||||0.0004|TWO_SIDED|95.0|1.36|2.895|||Chi-squared||Estimated from Cox Regression adjusted by baseline PAH medication status (0-1 vs 2) as the covariate. Hazard ratio \>1 indicates a beneficial effect that favors bardoxolone methyl.|||2.895|1.360|0.0004
71102030|NCT03379870|141711971|SUPERIORITY|Analyzed Consonant Nucleus Consonant (CNC) Word scores obtained 12-months post-activation to evaluate differences between groups. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis to control for potential floor or ceiling effects (e.g., scores \<20%).||||||0.768||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||||||.768
71102031|NCT03379870|141711972|SUPERIORITY|Analyzed BKB-SIN scores obtained 12-months post-activation to evaluate differences between groups. Scores range from -6 to +21 and lower scores are better.||||||0.529||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||||||.529
71102032|NCT03379870|141711973|SUPERIORITY|Analyzed SSQ scores obtained pre-operatively and at 12-months post-activation to evaluate benefit of cochlear implantation.||||||0.01||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||||||.010
71102033|NCT03379870|141711974|SUPERIORITY|Analyzed receptive language scores pre-operatively and 12-months post activation to test for change over time and differences between groups.|||||>|0.069||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||||||>.069
71102034|NCT03379870|141711975|SUPERIORITY|Analyzed articulation scores pre-operative and 12-months post activation to test for change over time and differences between groups.||||||0.02||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|Main effect of test point (pre-operative vs post-activation)||||||.02
71102035|NCT03379870|141711976|SUPERIORITY|Analyzed expressive language scores pre-operatively and 12-months post activation to test for change over time and differences between groups.||||||0.007||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|Main effect of test point (pre-operative vs post activation)||||||.007
71102036|NCT01557569|141712004|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.413|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||Due to skewed data, Kruskal Wallis Test was used.||||<0.05
71102037|NCT02254460|141712005|SUPERIORITY_OR_OTHER||[Treatment difference]|1.74||||0.0944|TWO_SIDED|95.0|0.9|3.34|||ANOVA||Treatment difference from ANOVA of log transformed data. Back transformed data are presented. This therefore represents the iron absorption ratio of the Micronutrient Fortified Drink (Test) to the Non-Fortified Drink (Control).|||3.34|0.90|0.0944
71045181|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|1.81||||0.0024|TWO_SIDED|95.0|1.23|2.65|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.65|1.23|0.0024
71045182|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|2.17|||<|0.0001|TWO_SIDED|95.0|1.49|3.16|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.16|1.49|<.0001
71045183|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0373|TWO_SIDED|95.0|1.04|3.14|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.14|1.04|0.0373
71102038|NCT02943499|141712006|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||To examine between-group differences in pre- vs. post-treatment cue reactivity, the post-treatment PCC BOLD response for the smoking vs neutral contrast was subtracted from the baseline response. The groups were then compared directly on this measure using a t-test.||||0.92
71102039|NCT00557440|141712016|SUPERIORITY_OR_OTHER||LS Mean Difference|0.165|STANDARD_ERROR_OF_MEAN|0.0492||0.001|TWO_SIDED|95.0|0.066|0.263||Statistical significance (two-sided) at 5% level. p-values were not corrected for multiplicity.|ANCOVA|Treatment, period, sequence and center as fixed effects, period baseline FEV1 as a covariate, and patient nested within sequence as a random effect.||||0.263|0.066|0.001
71102040|NCT03524157|141712021|NON_INFERIORITY|it will be considered non-inferior if there are no differences greater than 20%.||||||0.273|||||||Kruskal-Wallis|||||||0.273
71102041|NCT03524157|141712022|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%||||||0.788|||||||Kruskal-Wallis|||||||0.788
71102042|NCT03524157|141712024|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%|||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
70925414|NCT03232138|141344227|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) baseline positive cells. Caspase-3 positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.242||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||weak intensity positive nuclei. Mean (95%CI) at baseline.||||0.242
70925415|NCT03232138|141344227|EQUIVALENCE|-sided P-value in the analysis, Mean (95%CI) baseline positive cells. Caspase-3 positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.985||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||Moderate intensity positive nuclei. Mean (95%CI) at baseline.||||0.985
70925416|NCT03232138|141344227|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) baseline positive cells. Caspase-3 positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.547||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||Strong intensity positive nuclei. Mean (95%CI) at baseline.||||0.547
70925417|NCT03232138|141344227|EQUIVALENCE|used 2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for all positive cells. Caspase-3 all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.778||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||All positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.778
70925418|NCT03232138|141344227|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. Caspase-3 all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker||||||0.685||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||Weak intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.685
70925419|NCT03232138|141344227|EQUIVALENCE|-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. Caspase-3 all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker||||||0.469||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||Moderate intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.469
70925420|NCT03232138|141344227|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. Caspase-3 all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarke||||||0.052||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||strong intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.052
70925421|NCT03232138|141344228|EQUIVALENCE|This analysis was focused on the gene set that were found to be upregulated in lung cancer. the objective was to examine if sulforaphane treatment for 12 months had any significant impact on the expression of these lung-cancer associated upregulated genes in bronchial brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RNA integrity number or RIN.|Slope|0.02|STANDARD_ERROR_OF_MEAN|0.1||0.82|TWO_SIDED|||||Hypothesis: Sulforaphane treatment downregulate these genes whose over-expressions are associated with risk of lung cancer.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after 12-month sulforaphane treatment.|||||0.82
70925422|NCT03232138|141344229|EQUIVALENCE|This analysis was focused on the gene set that were found to be down-regulated in lung cancer. The objective was to examine if sulforaphane treatment for 12 months had any significant impact on the expression of these lung-cancer associated down-regulated genes in bronchial brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.1||0.5|TWO_SIDED|||||Hypothesis: Sulforaphane treatment would upregulate these genes whose down-expressions are associated with lung cancer risk.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after 12-month sulforaphane treatment.|||||0.50
71008685|NCT02055976|141525241|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-32.9411|STANDARD_ERROR_OF_MEAN|7.8656|<|0.001|TWO_SIDED|95.0|-48.5748|-17.3075|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-17.3075|-48.5748|<0.001
71102043|NCT03524157|141712025|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%||||||0.008|||||||Kruskal-Wallis|||||||0.008
71006672|NCT02607865|141521492|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.0|-2.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-2.0|-3.0|< 0.0001
71006673|NCT02607865|141521492|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.0|-1.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-1.1|-2.0|< 0.0001
71006674|NCT02607865|141521492|SUPERIORITY|This hypothesis was not controlled for multiplicity, since the non-inferiority test of change in HbA1c for oral semaglutide 3 mg versus sitagliptin 100 mg could not be confirmed. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.6|||=|0.0185|TWO_SIDED|95.0|-1.1|-0.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 3 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.1|-1.1|= 0.0185
71006675|NCT02607865|141521492|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.1|-2.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-2.1|-3.1|<0.0001
71006676|NCT02607865|141521492|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-1.5|||<|0.0001|TWO_SIDED|95.0|-2.0|-1.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.1|-2.0|<0.0001
71006677|NCT02607865|141521492|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|type Mean treatment difference|-0.5|||=|0.0257|TWO_SIDED|95.0|-1.0|-0.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 3 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.1|-1.0|=0.0257
71008686|NCT02055976|141525241|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-31.3176|STANDARD_ERROR_OF_MEAN|7.9032|<|0.001|TWO_SIDED|95.0|-47.0238|-15.6114|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-15.6114|-47.0238|<0.001
71102044|NCT03524157|141712026|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%|||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
71102045|NCT03524157|141712028|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%|||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
71102046|NCT03524157|141712029|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%|||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
71102047|NCT03524157|141712030|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%|||||>|0.05|||||||Chi-squared|||||||>0.05
71045184|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|2.17||||0.0046|TWO_SIDED|95.0|1.27|3.72|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.72|1.27|0.0046
71045185|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|2.95||||0.0683|TWO_SIDED|95.0|0.92|9.47|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||9.47|0.92|0.0683
71045186|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|3.77||||0.0214|TWO_SIDED|95.0|1.22|11.66|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||11.66|1.22|0.0214
71045187|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0006|TWO_SIDED|95.0|1.3|2.58|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.58|1.30|0.0006
71045188|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0048|TWO_SIDED|95.0|1.16|2.28|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.28|1.16|0.0048
71045189|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|1.84||||0.0012|TWO_SIDED|95.0|1.27|2.65|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.65|1.27|0.0012
71102048|NCT01592747|141712031|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.659|TWO_SIDED|95.0|0.7|1.8|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel test was performed controlling for Autism Spectrum Disorder (ASD) subtype. Odds ratio was calculated for placebo vs. memantine full dose.||1.8|0.7|0.6590
71102049|NCT01592747|141712031|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.7839|TWO_SIDED|95.0|0.7|1.7|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel test was performed controlling for Autism Spectrum Disorder (ASD) subtype. Odds ratio was calculated for placebo vs. Memantine reduced dose||1.7|0.7|0.7839
71045190|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|2.41|||<|0.0001|TWO_SIDED|95.0|1.68|3.47|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.47|1.68|<.0001
71045191|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0537|TWO_SIDED|95.0|0.99|2.74|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.74|0.99|0.0537
71045192|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|2.55||||0.0001|TWO_SIDED|95.0|1.58|4.13|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.13|1.58|0.0001
71045193|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|2.26||||0.1155|TWO_SIDED|95.0|0.82|6.27|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||6.27|0.82|0.1155
71045194|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|3.0||||0.0271|TWO_SIDED|95.0|1.13|7.96|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||7.96|1.13|0.0271
71045195|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0007|TWO_SIDED|95.0|1.3|2.63|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.63|1.30|0.0007
71045196|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0011|TWO_SIDED|95.0|1.26|2.56|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.56|1.26|0.0011
71045197|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|1.79||||0.0009|TWO_SIDED|95.0|1.27|2.52|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.52|1.27|0.0009
71102050|NCT01592747|141712033|SUPERIORITY_OR_OTHER||Least squares mean difference|0.1||||0.8136|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||||0.7|-0.5|0.8136
71102051|NCT01592747|141712033|SUPERIORITY_OR_OTHER||Least squares mean difference|0.0||||0.9244|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||||0.5|-0.6|0.9244
71102052|NCT01592747|141712034|SUPERIORITY_OR_OTHER||Least squares mean difference|0.1||||0.7611|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||||0.7|-0.5|0.7611
71006678|NCT02607865|141521513|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.34|||=|0.0063|TWO_SIDED|95.0|1.09|1.65||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 3 mg / Sitagliptin 100 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.65|1.09|=0.0063
71006679|NCT02607865|141521513|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.77|||=|0.0221|TWO_SIDED|95.0|0.61|0.96||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 7 mg / Sitagliptin 100 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.96|0.61|=0.0221
71006680|NCT02607865|141521513|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.41|0.68||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Sitagliptin 100 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.68|0.41|<0.0001
71006681|NCT02607865|141521514|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.33|||=|0.016|TWO_SIDED|95.0|1.05|1.68||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 3 mg / Sitagliptin 100 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||1.68|1.05|=0.0160
71006682|NCT02607865|141521514|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.66|||=|0.0022|TWO_SIDED|95.0|0.51|0.86||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 7 mg / Sitagliptin 100 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.86|0.51|=0.0022
71006683|NCT02607865|141521514|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.31|||<|0.0001|TWO_SIDED|95.0|0.22|0.43||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Sitagliptin 100 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.43|0.22|<0.0001
71006684|NCT01714336|141521599|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Regression, Logistic|||||||0.75
71006685|NCT01766401|141521602|SUPERIORITY||Least Squares Mean Difference|-1.5||||0.0438|TWO_SIDED|95.0|-2.96|-0.04|||MMRM|||||-0.04|-2.96|0.0438
71006686|NCT01766401|141521603|SUPERIORITY||Least Squares Mean Difference|-1.41||||0.0868|TWO_SIDED|95.0|-3.02|0.2|||MMRM|||||0.20|-3.02|0.0868
71006687|NCT01523613|141521604|SUPERIORITY|||||||0.262|||||||Fisher Exact|||||||0.262
71102053|NCT01592747|141712034|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.3176|TWO_SIDED|95.0|-0.3|0.9|||ANCOVA|||||0.9|-0.3|0.3176
71006688|NCT01523613|141521605|SUPERIORITY|||||||0.523|||||||Fisher Exact|||||||0.523
71006689|NCT01523613|141521606|SUPERIORITY|||||||0.1|||||||Fisher Exact|||||||0.100
71006690|NCT01801189|141521692|SUPERIORITY|||||||0.1||||||Threshold for significance was P \<0.05.|t-test, 1 sided|||||||0.10
71006691|NCT01801189|141521692|SUPERIORITY|||||||0.23||||||Threshold for significance \<0.05|t-test, 1 sided|||POD 1||||.23
71006692|NCT01801189|141521692|SUPERIORITY|||||||0.31||||||Threshold for significance \<0.05|t-test, 1 sided|||POD 2||||.31
71006693|NCT03958149|141521709|SUPERIORITY||||||<|0.001|||||||Independent t-test|||||||<0.001
71006694|NCT03958149|141521710|SUPERIORITY||||||<|0.05|||||||Factorial Mixed ANOVA|||||||<0.05
71006695|NCT00908050|141521732|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0394|||||||Chi-squared|||The averaged data calculated from three nights in each recording period for each subject will be submitted to statistical analysis. Descriptive and non-parametric statistics will be used for the secondary end-points.||||0.0394
71006696|NCT03798366|141521786|SUPERIORITY||Least square (LS) mean difference|-0.5|STANDARD_ERROR_OF_MEAN|1.29||0.6757|TWO_SIDED|95.0|-3.1|2.0|||Mixed Models Analysis||A negative difference indicates a greater improvement in the GLPG1690 treatment group.|Results were estimated using a mixed-effect model repeated measure using treatment and visit as fixed effects, baseline mRSS score and country as covariates, treatment-visit as interaction terms, and participant as a random effect. The variance-covariance matrix used in the model was compound symmetric.||2.0|-3.1|0.6757
71006697|NCT03798366|141521787|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|1.31||0.6079|TWO_SIDED|95.0|-3.3|1.9|||Mixed Models Analysis||A negative difference indicates a greater improvement in the GLPG1690 treatment group.|Results were estimated using a mixed-effect model repeated measure using treatment and visit as fixed effects, baseline mRSS score and country as covariates, treatment-visit as interaction terms, and participant as a random effect. The variance-covariance matrix used in the model was compound symmetric.||1.9|-3.3|0.6079
71006698|NCT03798366|141521788|SUPERIORITY||LS mean difference|-2.1|STANDARD_ERROR_OF_MEAN|1.35||0.1298|TWO_SIDED|95.0|-4.8|0.6|||Mixed Models Analysis||A negative difference indicates a greater improvement in the GLPG1690 treatment group.|Results were estimated using a mixed-effect model repeated measure using treatment and visit as fixed effects, baseline mRSS score and country as covariates, treatment-visit as interaction terms, and participant as a random effect. The variance-covariance matrix used in the model was compound symmetric.||0.6|-4.8|0.1298
71102054|NCT01592747|141712035|SUPERIORITY_OR_OTHER||Least squares mean difference|0.0||||0.902|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||||0.6|-0.5|0.9020
71102055|NCT01592747|141712035|SUPERIORITY_OR_OTHER||Least squares mean difference|0.4||||0.1279|TWO_SIDED|95.0|-0.1|1.0|||ANCOVA|||||1.0|-0.1|0.1279
71102056|NCT01592747|141712036|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.4144|TWO_SIDED|95.0|-0.4|1.1|||ANCOVA|||||1.1|-0.4|0.4144
71006699|NCT03798366|141521789|SUPERIORITY||LS mean difference|-2.8|STANDARD_ERROR_OF_MEAN|1.36||0.0411|TWO_SIDED|95.0|-5.6|-0.1|||Mixed Models Analysis||A negative difference indicates a greater improvement in the GLPG1690 treatment group.|Results were estimated using a mixed-effect model repeated measure using treatment and visit as fixed effects, baseline mRSS score and country as covariates, treatment-visit as interaction terms, and participant as a random effect. The variance-covariance matrix used in the model was compound symmetric.||-0.1|-5.6|0.0411
71006700|NCT00474539|141521793|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for immune response induced by NeisVac-C was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) greater than (\>) -10%.|Difference|-0.5||||||95.0|-3.3|2.0||||||For Meningococcal C the difference in percentages between the two groups (13vPnC - 7vPnC) at \>=1:8 titer was calculated||2.0|-3.3|
71006701|NCT00474539|141521796|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for or immune response induced by NeisVac-C was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.86||||||95.0|0.69|1.08||||||For Meningococcal C the GMT ratio (13vPnC/7vPnC) was calculated||1.08|0.69|
71006702|NCT00474539|141521796|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for or immune response induced by NeisVac-C was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.23||||||95.0|0.97|1.55||||||For Meningococcal C the GMT ratio (13vPnC/7vPnC) was calculated||1.55|0.97|
71006703|NCT00474539|141521797|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.6||||||95.0|-3.5|2.0||||||For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.10 IU/mL threshold was calculated||2.0|-3.5|
71006704|NCT00474539|141521797|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.9|1.7||||||For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.01 IU/mL threshold was calculated||1.7|-1.9|
71006705|NCT00474539|141521797|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.2||||||95.0|-4.4|4.0||||||For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.10 IU/mL threshold was calculated||4.0|-4.4|
71006706|NCT00474539|141521797|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-2.1|2.0||||||For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.01 IU/mL threshold was calculated||2.0|-2.1|
71006707|NCT00474539|141521797|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Ratio|0.0||||||95.0|-2.2|2.2||||||For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.10 IU/mL threshold was calculated||2.2|-2.2|
71006708|NCT00474539|141521797|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Ratio|0.0||||||95.0|-2.2|2.2||||||For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.01 IU/mL threshold was calculated||2.2|-2.2|
71006709|NCT00474539|141521797|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Ratio|0.0||||||95.0|-2.3|2.2||||||For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.10 IU/mL threshold was calculated||2.2|-2.3|
71006710|NCT00474539|141521797|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Ratio|0.0||||||95.0|-2.3|2.2||||||For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.01 IU/mL threshold was calculated||2.2|-2.3|
71006711|NCT00474539|141521798|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.86||||||95.0|0.72|1.03||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||1.03|0.72|
71006712|NCT00474539|141521798|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.91||||||95.0|0.74|1.12||||||For tetanus the GMC ratio (13vPnC/7vPnC) was calculated||1.12|0.74|
71006713|NCT00474539|141521798|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.93||||||95.0|0.78|1.1||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||1.10|0.78|
71102057|NCT01592747|141712036|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.4212|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||||1.0|-0.4|0.4212
71102058|NCT01592747|141712037|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.2||||0.6238|TWO_SIDED|95.0|-0.9|0.5|||ANCOVA|||||0.5|-0.9|0.6238
71102059|NCT01592747|141712037|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2||||0.5957|TWO_SIDED|95.0|-0.5|0.9|||ANCOVA|||||0.9|-0.5|0.5957
71102060|NCT01592747|141712038|SUPERIORITY_OR_OTHER||Least squares mean difference|0.1||||0.864|TWO_SIDED|95.0|-0.6|0.7|||ANCOVA|||||0.7|-0.6|0.8640
71102061|NCT01592747|141712038|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.4362|TWO_SIDED|95.0|-0.4|0.9|||ANCOVA|||||0.9|-0.4|0.4362
71102062|NCT01592747|141712039|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.1||||0.7182|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|||||0.6|-0.8|0.7182
71102063|NCT01592747|141712039|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.1||||0.839|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|||||0.6|-0.8|0.8390
71102064|NCT01592747|141712040|SUPERIORITY_OR_OTHER||Least squares mean difference|0.7||||0.0813|TWO_SIDED|95.0|-0.1|1.4|||ANCOVA|||||1.4|-0.1|0.0813
71102065|NCT01592747|141712040|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.4365|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||||1.0|-0.4|0.4365
71102066|NCT01592747|141712041|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.4213|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||||1.0|-0.4|0.4213
71006714|NCT00474539|141521798|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.0||||||95.0|0.81|1.24||||||For tetanus the GMC ratio (13vPnC/7vPnC) was calculated||1.24|0.81|
71006715|NCT00474539|141521801|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for immune response induced by NeisVac-C was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.6||||||95.0|-1.7|3.2||||||For Meningococcal C the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥ 1:8 titer was calculated.||3.2|-1.7|
71006716|NCT03442595|141521822|OTHER|test of difference in change of A1C between the two groups|||||<|0.001|||||||t-test, 2 sided|||The study was powered to detect a difference of 0.5% in the change in A1C with SD = 2 with 80\& at alopha = 0.;05 with a sample size of 128 in each group (paired t-test). The study reaches 100% power to detect this observed difference with an alpha level of 0.01.||||<0.001
71006717|NCT01603628|141521868|SUPERIORITY||Least Squares (LS) Mean Difference|-0.26||||0.01|TWO_SIDED|95.0|-0.453|-0.063||MMRM including baseline MAS-B ankle score (knee extended) as a covariate and factors of age, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure where age is represented by stratification categories.|Mixed Model Repeated Measures|||||-0.063|-0.453|0.010
71006718|NCT01603628|141521868|SUPERIORITY||LS Mean Difference|-0.21||||0.033|TWO_SIDED|95.0|-0.405|-0.018||MMRM including baseline MAS-B ankle score (knee extended) as a covariate and factors of age, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure where age is represented by stratification categories.|Mixed Model Repeated Measures|||||-0.018|-0.405|0.033
71006719|NCT01603628|141521869|SUPERIORITY||LS Mean Difference|0.29||||0.023|TWO_SIDED|95.0|0.04|0.532||MMRM including baseline MAS-B ankle score (knee extended) as a covariate and factors of age, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure where age is represented by stratification categories.|Mixed Model Repeated Measures|||||0.532|0.040|0.023
71006720|NCT01603628|141521869|SUPERIORITY||LS Mean Difference|0.13||||0.299|TWO_SIDED|95.0|-0.115|0.374||MMRM including baseline MAS-B ankle score (knee extended) as a covariate and factors of age, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure where age is represented by stratification categories.|Mixed Model Repeated Measures|||||0.374|-0.115|0.299
71102067|NCT01592747|141712041|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.4267|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||||1.0|-0.4|0.4267
71102068|NCT01592747|141712042|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.3713||95.0|-0.4|1.0|||ANCOVA|||||1.0|-0.4|0.3713
71102069|NCT01592747|141712042|SUPERIORITY_OR_OTHER||Least squares mean difference|0.4||||0.2855|TWO_SIDED|95.0|-0.3|1.1|||ANCOVA|||||1.1|-0.3|0.2855
71102070|NCT02853136|141712043|OTHER||Adjusted geometric Mean ratio [%]|3107.8|||||TWO_SIDED|90.0|2332.9|4140.1|||||The estimated parameter was the adjusted geometric Mean (gMean) ratio \[%\] = adjusted gMean T2/ adjusted gMean R2. Intra-individual geometric coefficient of variation \[%\] =42.7.|The statistical model used for the analysis of the endpoint was an ANOVA (Analysis of Variance) model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||4140.10|2332.90|
71102071|NCT02853136|141712044|OTHER||Adjusted geometric Mean ratio [%]|659.0|||||TWO_SIDED|90.0|489.791|886.676|||||The estimated parameter was the adjusted geometric Mean (gMean) ratio \[%\] = adjusted gMean T2/ adjusted gMean R2. Intra-individual geometric coefficient of variation \[%\]=44.8.|The statistical model used for the analysis of the endpoint was an ANOVA (Analysis of Variance) model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||886.676|489.791|
71006721|NCT01603628|141521870|SUPERIORITY||LS Mean Difference|0.41||||0.005|TWO_SIDED|95.0|0.126|0.704||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 8, Active Goal||0.704|0.126|0.005
71102072|NCT02853136|141712045|OTHER||Adjusted geometric Mean ratio [%]|3103.41|||||TWO_SIDED|90.0|2330.5|4132.65|||||"The estimated parameter was the adjusted geometric Mean (gMean) ratio \[%\] = adjusted gMean T2/ adjusted gMean R2.~Intra-individual geometric coefficient of variation \[%\] =42.7."|The statistical model used for the analysis of the endpoint was an ANOVA (Analysis of Variance) model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||4132.65|2330.50|
71102073|NCT04620668|141712052|SUPERIORITY||||||<|0.001|||||||Mixed ANOVA|Assessing interaction between experimental group and time point.||||||<0.001
71006722|NCT01603628|141521870|SUPERIORITY||LS Mean Difference|0.29||||0.047|TWO_SIDED|95.0|0.004|0.573||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 8, Active Goal||0.573|0.004|0.047
71102074|NCT04620668|141712052|SUPERIORITY||||||<|0.001|||||||Repeated Measures ANOVA|Assessing change within treatment group (follow-up to Mixed ANOVA).||||||<0.001
71006723|NCT01603628|141521870|SUPERIORITY||LS Mean Difference|0.45||||0.004|TWO_SIDED|95.0|0.145|0.756||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 8, Passive Goal||0.756|0.145|0.004
71006724|NCT01603628|141521870|SUPERIORITY||LS Mean Difference|0.44||||0.004|TWO_SIDED|95.0|0.141|0.74||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 8, Passive Goal||0.740|0.141|0.004
71006725|NCT01603628|141521870|SUPERIORITY||LS Mean Difference|0.49||||0.001|TWO_SIDED|95.0|0.191|0.797||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 12, Active Goal||0.797|0.191|0.001
71006726|NCT01603628|141521870|SUPERIORITY||LS Mean Difference|0.22||||0.153|TWO_SIDED|95.0|-0.081|0.541||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 12, Active Goal||0.541|-0.081|0.153
71006727|NCT01603628|141521870|SUPERIORITY||LS Mean Difference|0.41||||0.01|TWO_SIDED|95.0|0.1|0.711||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 12, Passive Goal||0.711|0.100|0.010
71006728|NCT01603628|141521870|SUPERIORITY||LS Mean Difference|0.27||||0.078|TWO_SIDED|95.0|-0.031|0.571||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 12, Passive Goal||0.571|-0.031|0.078
71006729|NCT01603628|141521871|SUPERIORITY||LS Mean Difference|-1.99||||0.158|TWO_SIDED|95.0|-4.768|0.779||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2||0.779|-4.768|0.158
71006730|NCT01603628|141521871|SUPERIORITY||LS Mean Difference|-3.25||||0.02|TWO_SIDED|95.0|-5.974|-0.524||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2||-0.524|-5.974|0.020
71006731|NCT01603628|141521871|SUPERIORITY||LS Mean Difference|-1.42||||0.363|TWO_SIDED|95.0|-4.489|1.648||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4||1.648|-4.489|0.363
71006732|NCT01603628|141521871|SUPERIORITY||LS Mean Difference|-2.11||||0.171|TWO_SIDED|95.0|-5.127|0.914||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4||0.914|-5.127|0.171
71006733|NCT01603628|141521871|SUPERIORITY||LS Mean Difference|-3.33||||0.02|TWO_SIDED|95.0|-6.143|-0.525||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6||-0.525|-6.143|0.020
71006734|NCT01603628|141521871|SUPERIORITY||LS Mean Difference|-3.92||||0.006|TWO_SIDED|95.0|-6.688|-1.148||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6||-1.148|-6.688|0.006
71102075|NCT04620668|141712052|SUPERIORITY|||||||0.044|||||||Dependent t-test (2-sided)|"Assessing change within treatment group from baseline to week 2 (follow-up to Repeated Measures ANOVA).~Bonferroni-adjusted p value."||||||0.044
71102076|NCT04620668|141712052|SUPERIORITY|||||||0.001|||||||Dependent t-test (2-sided)|"Assessing change within treatment group from week 2 to week 4 (follow-up to Repeated Measures ANOVA).~Bonferroni-adjusted p value."||||||0.001
71102077|NCT04620668|141712052|SUPERIORITY|||||||0.731|||||||Repeated Measures ANOVA|Assessing change within control group (follow-up to Mixed ANOVA).||||||0.731
71102078|NCT04620668|141712053|SUPERIORITY||||||<|0.001|||||||Mixed ANOVA|Assessing interaction between experimental group and time point.||||||<0.001
71102079|NCT04620668|141712053|SUPERIORITY||||||<|0.001|||||||Repeated Measures ANOVA|Assessing change within treatment group (follow-up to Mixed ANOVA).||||||<0.001
71102080|NCT04620668|141712053|SUPERIORITY|||||||0.05|||||||Dependent t-test (2-sided)|"Assessing change within treatment group from baseline to week 2 (follow-up to Repeated Measures ANOVA).~Bonferroni-adjusted p value."||||||0.05
71102081|NCT04620668|141712053|SUPERIORITY|||||||0.024|||||||Dependent t-test (2-sided)|"Assessing change within treatment group from week 2 to week 4 (follow-up to Repeated Measures ANOVA).~Bonferroni-adjusted p value."||||||0.024
71102082|NCT04620668|141712053|SUPERIORITY|||||||0.674|||||||Repeated Measures ANOVA|Assessing change within control group (follow-up to Mixed ANOVA).||||||0.674
71102083|NCT04620668|141712054|SUPERIORITY|||||||0.159|||||||Mixed ANOVA|Assessing interaction between experimental group and time point.||||||0.159
71102084|NCT04620668|141712055|SUPERIORITY|||||||0.326|||||||Mixed ANOVA|Assessing interaction between experimental group and time point.||||||0.326
71102085|NCT05273437|141712075|OTHER|We conducted a Bayesian Regression for all available participants, then visualized the results. (N x 16 table, N: number of participants).|Credibility interval|80.0|||||TWO_SIDED||||||Bayesian Regression|We explicitly sought 80% credibility of at least 100 steps more within the 3-hour increment in comparison to the intervention.|We decided that 100 steps/3 hours is the minimum value of the MAP intervention effect estimate and that an INUS condition is valid only if there is at least an 80% chance of achieving an effect beyond 100 steps/3 hours.|We hypothesized that some individuals have their own time and decision-policy-specific response pattern regardless of day elapsed since the beginning of the intervention. We did not hypothesize the direction of the effect variation.|The decision point was the unit of analysis. For the Bayesian Regression, we used Markov Chain Monte Carlo (MCMC). Four sampling chains were used when performing Bayesian modeling. The number of estimation samples and target acceptance rate were gradually increased until numerical stability was achieved. The number of estimation samples was increased by multiplied by 2, as advised by previous literature, depending on the ratio of convergence diagnostics R̂ \> 1.1. We used 100 steps increase during 3 hours as the effect threshold value. We assumed that there is an effect only if the estimated effect is more than 80% probable (i.e., the credibility interval is over 100 steps/3 hours) and the Maximum A Posteriori Point (MAP) of the effect is more than 100 steps/3 hours. Otherwise, there is no effect. Among the models with effects, we clipped to 1000 steps/3hours as a maximum if the MAP was greater than 1000 steps/3 hours.|||
71102086|NCT01111552|141712097|SUPERIORITY||Treatment Difference|-1.3|||=|0.595|TWO_SIDED|95.0|-5.9|3.4|||ANCOVA|||||3.4|-5.9|=0.595
71102087|NCT01111552|141712097|SUPERIORITY||Treatment Difference|0.4|||=|0.869|TWO_SIDED|95.0|-4.4|5.1|||ANCOVA|||||5.1|-4.4|=0.869
71102088|NCT01111552|141712098|SUPERIORITY||Treatment Difference|-0.1|||=|0.856|TWO_SIDED|95.0|-0.7|0.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Row Mean Scores Test was used to determine the p-value.||||0.6|-0.7|=0.856
71102089|NCT01111552|141712098|SUPERIORITY||Treatment Difference|0.1|||=|0.838|TWO_SIDED|95.0|-0.6|0.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Row Mean Scores Test was used to determine the p-value.||||0.7|-0.6|=0.838
71102090|NCT01111552|141712099|SUPERIORITY||Treatment Difference|-0.2|||=|0.765|TWO_SIDED|95.0|-1.6|1.2|||ANCOVA|||||1.2|-1.6|=0.765
71102091|NCT01111552|141712099|SUPERIORITY||Treatment Difference|0.2|||=|0.76|TWO_SIDED|95.0|-1.2|1.6|||ANCOVA|||||1.6|-1.2|=0.760
71006735|NCT01603628|141521871|SUPERIORITY||LS Mean Difference|-2.07||||0.254|TWO_SIDED|95.0|-5.621|1.491||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8||1.491|-5.621|0.254
71006736|NCT01603628|141521871|SUPERIORITY||LS Mean Difference|-2.46||||0.165|TWO_SIDED|95.0|-5.935|1.014||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8||1.014|-5.935|0.165
71102092|NCT02528305|141712107|SUPERIORITY_OR_OTHER|||||||0.474|||||||ANOVA|||||||0.474
71006737|NCT01603628|141521871|SUPERIORITY||LS Mean Difference|-2.61||||0.078|TWO_SIDED|95.0|-5.517|0.296||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12||0.296|-5.517|0.078
71006738|NCT01603628|141521871|SUPERIORITY||LS Mean Difference|-1.09||||0.451|TWO_SIDED|95.0|-3.944|1.758||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12||1.758|-3.944|0.451
71006739|NCT04107935|141521892|SUPERIORITY|||||||0.983||||||Propensity score matching was used to form pairs of intervention and control participants. Specifically, a greedy matching procedure with a matching caliper of 0.2 of the standard deviation of the logit of the propensity score was used.|Mixed Models Analysis|Since baseline characteristics achieved a good balance, those variables were not entered into the propensity score matched model.||||||0.9830
71006740|NCT04107935|141521893|SUPERIORITY|||||||0.8365||||||Adjusted for age, race, body mass index, and time|Mixed Models Analysis|||||||0.8365
71102093|NCT02528305|141712108|SUPERIORITY_OR_OTHER|||||||0.174|||||||ANOVA|||||||0.174
71102094|NCT02528305|141712109|SUPERIORITY_OR_OTHER|||||||0.303|||||||ANOVA|||||||0.303
71102095|NCT02528305|141712110|SUPERIORITY|||||||0.023|||||||ANOVA|||||||0.023
71102096|NCT02528305|141712111|SUPERIORITY_OR_OTHER|||||||0.092|||||||ANOVA|For the analysis of Total body fat||||||0.092
71102097|NCT02528305|141712111|SUPERIORITY_OR_OTHER|||||||0.101|||||||ANOVA|For the analysis of Trunk fat||||||0.101
71102098|NCT02528305|141712112|SUPERIORITY_OR_OTHER|||||||0.771|||||||ANOVA|For the analysis of systolic blood pressure||||||0.771
71102099|NCT02528305|141712112|SUPERIORITY_OR_OTHER|||||||0.028|||||||ANOVA|For the analysis of diastolic blood pressure||||||0.028
71102100|NCT02528305|141712113|SUPERIORITY_OR_OTHER|||||||0.099|||||||ANOVA|For the analysis of Physical Function||||||0.099
71102101|NCT02528305|141712113|SUPERIORITY_OR_OTHER|||||||0.566|||||||ANOVA|For the analysis of Social Function||||||0.566
71102102|NCT02528305|141712113|SUPERIORITY_OR_OTHER|||||||0.246|||||||ANOVA|For the analysis of Mental Health||||||0.246
71102103|NCT02528305|141712113|SUPERIORITY_OR_OTHER|||||||0.145|||||||ANOVA|For the analysis of Pain||||||0.145
71102104|NCT02528305|141712113|SUPERIORITY_OR_OTHER|||||||0.085|||||||ANOVA|For the analysis of Change in Health||||||0.085
71102105|NCT02528305|141712113|SUPERIORITY_OR_OTHER|||||||0.114|||||||ANOVA|For the analysis of Physical Role Limitation||||||0.114
71102106|NCT02528305|141712113|SUPERIORITY_OR_OTHER|||||||0.841|||||||ANOVA|For the analysis of Mental Role Limitation||||||0.841
71102107|NCT02528305|141712113|SUPERIORITY_OR_OTHER|||||||0.366|||||||ANOVA|For the analysis of Energy/Vitality||||||0.366
71102108|NCT02528305|141712113|SUPERIORITY_OR_OTHER|||||||0.745|||||||ANOVA|For the analysis of Health Perception||||||0.745
71102109|NCT02528305|141712114|SUPERIORITY_OR_OTHER|||||||0.31|||||||ANOVA|||||||0.310
71102110|NCT02528305|141712115|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71102111|NCT02528305|141712116|SUPERIORITY_OR_OTHER|||||||0.005|||||||ANOVA|||||||0.005
71102112|NCT02528305|141712117|SUPERIORITY_OR_OTHER|||||||0.793|||||||ANOVA|||||||0.793
71006741|NCT04107935|141521894|SUPERIORITY|||||||0.5727||||||Adjusted for age, race, body mass index, and time|Mixed Models Analysis|||||||0.5727
71102113|NCT02528305|141712118|SUPERIORITY_OR_OTHER|||||||0.513|||||||ANOVA|||||||0.513
71102114|NCT02528305|141712119|SUPERIORITY_OR_OTHER|||||||0.009|||||||ANOVA|||||||0.009
71006742|NCT04107935|141521895|SUPERIORITY|||||||0.9381||||||Adjusted for age, race, body mass index, and time|Mixed Models Analysis|||||||0.9381
71006743|NCT04107935|141521897|SUPERIORITY|||||||0.608||||||Adjusted for age, race, body mass index, and time|Mixed Models Analysis|||||||0.608
71006744|NCT01021553|141521898|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.16||||0.4959|TWO_SIDED|95.0|0.75|1.79|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|||1.79|0.75|0.4959
71006745|NCT01021553|141521898|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.11||||0.6161|TWO_SIDED|95.0|0.74|1.65|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|||1.65|0.74|0.6161
71006746|NCT01021553|141521898|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.13||||0.4971|TWO_SIDED|95.0|0.79|1.61|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|||1.61|0.79|0.4971
71006747|NCT01021553|141521899|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.03||||0.9037|TWO_SIDED|95.0|0.67|1.58|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Week 0 to 4||1.58|0.67|0.9037
71006748|NCT01021553|141521899|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.0||||0.9939|TWO_SIDED|95.0|0.67|1.48|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Week 0 to 4||1.48|0.67|0.9939
71006749|NCT01021553|141521899|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.01||||0.9541|TWO_SIDED|95.0|0.71|1.43|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Weeks 0-4||1.43|0.71|0.9541
71006750|NCT01021553|141521899|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.33||||0.2798|TWO_SIDED|95.0|0.79|2.24|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Weeks 4-8||2.24|0.79|0.2798
71006751|NCT01021553|141521899|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.09||||0.7255|TWO_SIDED|95.0|0.68|1.75|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Weeks 4-8||1.75|0.68|0.7255
71006752|NCT01021553|141521899|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.18||||0.4347|TWO_SIDED|95.0|0.77|1.8|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Weeks 4-8||1.80|0.77|0.4347
71006753|NCT01021553|141521900|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.14||||0.6583|TWO_SIDED|95.0|0.63|2.05|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|||2.05|0.63|0.6583
71006754|NCT01021553|141521900|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|0.96||||0.879|TWO_SIDED|95.0|0.56|1.65|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|||1.65|0.56|0.8790
71006755|NCT01021553|141521900|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.03||||0.8971|TWO_SIDED|95.0|0.64|1.67|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|||1.67|0.64|0.8971
71006756|NCT01021553|141521903|SUPERIORITY_OR_OTHER||Ratio of treatments|2.91|||||TWO_SIDED|90.0|2.43|3.48|||||For AUC (0-inf)|||3.48|2.43|
71006757|NCT01021553|141521903|SUPERIORITY_OR_OTHER||Ratio of treatments|2.98|||||TWO_SIDED|90.0|2.51|3.54||||||||3.54|2.51|
71006758|NCT01021553|141521904|SUPERIORITY_OR_OTHER||Ratio of treatments|3.63|||||TWO_SIDED|90.0|2.95|4.47||||||||4.47|2.95|
71006759|NCT00033293|141521913|OTHER||Chi-squared test statistic|8.125||||0.0044|TWO_SIDED|95.0||||No adjustments for multiple comparisons.|Chi-squared|A two-way test with a null hypothesis of no association, using SAS 9.4.||"The 5 categories of OMA ratings are: stance, gait, arm \& hand function, opsoclonus, \& mood/behavior. For each category, a patient's response will be based on a comparison of the baseline evaluation to the best of 3 time points: 2 months, 6 months \& 1 year. If a patient crosses over to the IVIG arm or switches to ACTH at any time, the patient will be considered a non-responder. The proportion of responders from the 2 treatment arms were compared using a chi-squared test."||||0.0044
71006760|NCT00033293|141521914|OTHER||Mean Difference (Net)|60.1979||||0.0919|ONE_SIDED||||||t-test, 1 sided|||The two samples from the respective treatment arms were compared using a one-sided t-test with a significance level of .05.||||0.0919
71006761|NCT00033293|141521915|OTHER|The two samples from the respective treatment arms were compared using a one-sided t-test with a significance level of .05.|Mean Difference (Net)|16.75||||0.2364|ONE_SIDED||||||t-test, 1 sided|||||||0.2364
71006762|NCT00935701|141521926|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Restless-Impulsive subscale||||0.01
71006763|NCT00935701|141521926|SUPERIORITY_OR_OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Emotional Lability subscale||||0.09
71006764|NCT00935701|141521926|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Global Index Total||||0.02
71006765|NCT00935701|141521926|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on DSM-IV Inattentive subscale||||0.01
71006766|NCT00935701|141521926|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on DSM-IV Hyperactive-Impulsive subscale||||0.03
71006767|NCT00935701|141521926|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on DSM-IV Total||||0.01
71006768|NCT00935701|141521927|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Bedtime Resistance subscale||||0.08
71006769|NCT00935701|141521927|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Sleep Onset Delay subscale||||0.03
71006770|NCT00935701|141521927|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Sleep Duration subscale||||0.82
71006771|NCT00935701|141521927|SUPERIORITY_OR_OTHER|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Sleep Anxiety subscale||||0.58
71006772|NCT00935701|141521927|SUPERIORITY_OR_OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Night Wakings subscale||||0.66
71006773|NCT00935701|141521927|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Parasomnias subscale||||0.18
71006774|NCT00935701|141521927|SUPERIORITY_OR_OTHER|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Daytime Sleepiness subscale||||0.31
71006775|NCT00935701|141521927|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Total Disturbance||||0.07
71006776|NCT00935701|141521928|SUPERIORITY_OR_OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Child Domain Total||||0.04
71006777|NCT00935701|141521928|SUPERIORITY_OR_OTHER|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Parent Domain Total||||0.31
71006778|NCT00935701|141521928|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Total Stress||||0.07
71006779|NCT03525613|141521941|SUPERIORITY||LS Mean Difference|-0.4114||||0.0004|TWO_SIDED|95.0|-0.6397|-0.1831|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + presence of choroidal neovascularization (CNV) in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area × analysis visit.||-0.1831|-0.6397|0.0004
71006780|NCT03525613|141521941|SUPERIORITY||LS Mean Difference|-0.318||||0.0055|TWO_SIDED|95.0|-0.5423|-0.0937|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area × analysis visit.||-0.0937|-0.5423|0.0055
71006781|NCT03525613|141521942|SUPERIORITY||LS Mean Difference|-0.9015|||<|0.0001|TWO_SIDED|95.0|-1.3026|-0.5004|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + baseline presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) × analysis visit.||-0.5004|-1.3026|<0.0001
71006782|NCT03525613|141521942|SUPERIORITY||LS Mean Difference|-0.7426||||0.0002|TWO_SIDED|95.0|-1.1282|-0.357|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + baseline presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) × analysis visit.||-0.3570|-1.1282|0.0002
71006783|NCT03525613|141521943|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.2234||||0.0007|TWO_SIDED|95.0|-0.3522|-0.0946|||MMRM model|||Estimates for Baseline to Month 6: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0946|-0.3522|0.0007
71006784|NCT03525613|141521943|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.1618||||0.0116|TWO_SIDED|95.0|-0.2874|-0.0361|||MMRM model|||Estimates for Baseline to Month 6: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0361|-0.2874|0.0116
71006785|NCT03525613|141521943|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.1862||||0.0181|TWO_SIDED|95.0|-0.3406|-0.0318|||MMRM model|||Estimates for Month 6 to Month 12: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0318|-0.3406|0.0181
71006786|NCT03525613|141521943|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.1526||||0.0467|TWO_SIDED|95.0|-0.303|-0.0023|||MMRM model|||Estimates for Month 6 to Month 12: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0023|-0.3030|0.0467
71006787|NCT03525613|141521943|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.2265||||0.0019|TWO_SIDED|95.0|-0.3696|-0.0834|||MMRM model|||Estimates for Month 12 to Month 18: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0834|-0.3696|0.0019
71102115|NCT01852214|141712124|SUPERIORITY_OR_OTHER|||||||0.022|||||||Mixed Models Analysis|||||||0.022
71006788|NCT03525613|141521943|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.1586||||0.0288|TWO_SIDED|95.0|-0.3009|-0.0164|||MMRM model|||Estimates for Month 12 to Month 18: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0164|-0.3009|0.0288
71006789|NCT03525613|141521943|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.2341||||0.008|TWO_SIDED|95.0|-0.4071|-0.0611|||MMRM model|||Estimates for Month 18 to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0611|-0.4071|0.0080
71006790|NCT03525613|141521943|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.2459||||0.0007|TWO_SIDED|95.0|-0.3886|-0.1031|||MMRM model|||Estimates for Month 18 to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.1031|-0.3886|0.0007
71006791|NCT03525613|141521943|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.8702|||<|0.0001|TWO_SIDED|95.0|-1.274|-0.4664|||MMRM model|||Estimates for Baseline to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.4664|-1.2740|<0.0001
71008687|NCT02055976|141525241|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-32.847|STANDARD_ERROR_OF_MEAN|7.8576|<|0.001|TWO_SIDED|95.0|-48.465|-17.2289|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-17.2289|-48.4650|<0.001
71102116|NCT01852214|141712125|SUPERIORITY_OR_OTHER|||||||0.086|||||||Mixed Models Analysis|||||||0.086
71102117|NCT02691494|141712135|SUPERIORITY||Odds Ratio (OR)|28.73|||<|0.001|TWO_SIDED|95.0|12.248|67.387||The P value for test of difference is by pooling the results from a logistic regression model including treatment as the main effect and baseline MBL volume as a covariate in each data set from multiple imputation.|Regression, Logistic|||||67.387|12.248|< 0.001
71102118|NCT02691494|141712135|SUPERIORITY||Odds Ratio (OR)|28.31|||<|0.001|TWO_SIDED|95.0|13.042|61.431||The P value for test of difference is by pooling the results from a logistic regression model including treatment as the main effect and baseline MBL volume as a covariate in each data set from multiple imputation.|Regression, Logistic|||||61.431|13.042|< 0.001
71006792|NCT03525613|141521943|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.7189||||0.0003|TWO_SIDED|95.0|-1.1039|-0.3339|||MMRM model|||Estimates for Baseline to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.3339|-1.1039|0.0003
71006793|NCT02584660|141521948|SUPERIORITY||Mean difference|-1.202|||<|0.0001|TWO_SIDED|95.0|-1.73|-0.674|||t-test|||||-0.674|-1.730|<.0001
71006794|NCT00461552|141521960|SUPERIORITY|||||||0.84||||||Treatment time month interaction|Mixed Models Analysis|||||||0.84
71006795|NCT00461552|141521961|OTHER|||||||0.4||||||Treatment time month interaction|Mixed Models Analysis|||||||0.4
71006796|NCT02120469|141521982|OTHER||||||||||||||||||Dose level B1 (eribulin 1.1 mg/m2 days 1 and 8 every 3 weeks with everolimus 5 mg daily) was defined as the highest dose with acceptable toxicity (RP2D).|||
71006797|NCT01846208|141521994|SUPERIORITY||Risk Difference (RD)|32.4||||0.009|TWO_SIDED|95.0|8.9|55.8|||Barnard's Exact Test|||% participants passed Year 2 SU OFC: Baked vs. Egg OIT-Randomized||55.8|8.9|0.009
71006798|NCT01846208|141521994|SUPERIORITY||Risk Difference (RD)|25.5||||0.031|TWO_SIDED|95.0|2.0|49.1|||Barnard's Exact Test|||% participants passed Year 2 SU OFC: Egg OIT-Randomized vs. Egg OIT-Assigned||49.1|2.0|0.031
71006799|NCT01846208|141521995|SUPERIORITY||Risk Difference (RD)|64.7|||<|0.0001|TWO_SIDED|95.0|43.9|85.6|||Barnard's Exact Test|||% participants desensitized to \>=4444 mg at Year 2 OFC: Baked vs. Egg OIT-Randomized||85.6|43.9|<0.0001
71006800|NCT01846208|141521995|SUPERIORITY||Risk Difference (RD)|17.7||||0.151|TWO_SIDED|95.0|-2.3|37.7|||Barnard's Exact Test|||% participants desensitized to \>=4444 mg at Year 2 OFC: Egg OIT-Randomized vs. Egg OIT-Assigned||37.7|-2.3|0.151
71006801|NCT01846208|141521995|SUPERIORITY||Risk Difference (RD)|44.3||||0.002|TWO_SIDED|95.0|19.4|69.2|||Barnard's Exact Test|||% participants desensitized to \>=4444 mg at Year 1 OFC: Baked vs. Egg OIT-Randomized||69.2|19.4|0.002
71006802|NCT01846208|141521995|SUPERIORITY||Risk Difference (RD)|17.5||||0.181|TWO_SIDED|95.0|-6.3|41.3|||Barnard's Exact Test|||% participants desensitized to \>=4444 mg at Year 1 OFC: Egg OIT-Randomized vs. Egg OIT-Assigned||41.3|-6.3|0.181
71102119|NCT02691494|141712136|SUPERIORITY||LS Mean of Difference|-194.5|STANDARD_ERROR_OF_MEAN|21.7|<|0.001|TWO_SIDED|||||The P value for test of difference between each elagolix treatment group and placebo is by pooling the results from an ANCOVA model with treatment as the main effect and baseline MBL volume as a covariate in each dataset from multiple imputation.|ANCOVA|||||||< 0.001
71006803|NCT01846208|141521997|SUPERIORITY||Risk Difference (RD)|-50.2||||0.003|TWO_SIDED|95.0|-78.4|-21.9|||Barnard's Exact Test|||% participants with unrestricted consumption of unbaked (concentrated) egg 3 years after randomization: Baked vs. Egg OIT-Randomized||-21.9|-78.4|0.003
71102120|NCT02691494|141712136|SUPERIORITY||LS Mean of Difference|-164.6|STANDARD_ERROR_OF_MEAN|18.87|<|0.001|TWO_SIDED|||||The P value for test of difference between each elagolix treatment group and placebo is by pooling the results from an ANCOVA model with treatment as the main effect and baseline MBL volume as a covariate in each dataset from multiple imputation.|ANCOVA|||||||< 0.001
71006804|NCT01846208|141521997|SUPERIORITY||Risk Difference (RD)|33.7||||0.023|TWO_SIDED|95.0|7.2|60.1|||Barnard's Exact Test|||% participants with unrestricted consumption of unbaked (concentrated) egg 3 years after randomization: Egg OIT-Randomized vs. Egg OIT-Assigned||60.1|7.2|0.023
71006805|NCT01424306|141521999|OTHER|||||||0.403||||||P value for the time x diet interaction reflects overall comparison of 3 dietary phases by RM-ANOVA|RM-ANOVA|||RM-ANOVA||||0.403
71006806|NCT01424306|141522000|OTHER|RM-ANOVA||||||0.933||||||P-diet: reflects an overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.933
71006807|NCT01424306|141522001|OTHER|RM-ANOVA||||||0.196||||||P-diet: reflects an overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.196
71006808|NCT01424306|141522002|OTHER|RM-ANOVA||||||0.88||||||Reflects an overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.880
71006809|NCT01424306|141522003|OTHER|RM-ANOVA|||||<|0.001||||||P-value reflects an overall comparison of the 3 dietary phases by RM-ANOVA|Repeated measures ANOVA|||||||<0.001
71006810|NCT01424306|141522004|OTHER|RM-ANOVA||||||0.366||||||P-value reflects an overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.366
71006811|NCT01424306|141522005|OTHER|RM-ANOVA||||||0.387||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.387
71006812|NCT01424306|141522006|OTHER|RM-ANOVA||||||0.476||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.476
71006813|NCT01424306|141522007|OTHER|RM-ANOVA||||||0.596||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.596
71006814|NCT01424306|141522008|OTHER|RM-ANOVA||||||0.492||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.492
71006815|NCT01424306|141522009|OTHER|RM-ANOVA||||||0.149||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.149
71006816|NCT01424306|141522010|OTHER|RM-ANOVA||||||0.056||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.056
71006817|NCT01424306|141522011|OTHER|RM-ANOVA||||||0.52||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.520
71006818|NCT00369928|141522012|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.88||||0.982|TWO_SIDED|80.0|0.56|1.38|||Cochran-Mantel-Haenszel|||||1.38|0.56|0.982
71006819|NCT00369928|141522012|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.79||||0.666|TWO_SIDED|80.0|0.5|1.25|||Cochran-Mantel-Haenszel|||||1.25|0.50|0.666
71006820|NCT02274766|141522030|SUPERIORITY||Least Squares Mean Difference|-14.4|STANDARD_ERROR_OF_MEAN|3.03|<|0.0001|TWO_SIDED|95.0|-20.4|-8.3|||Linear Mixed Model w/ Repeated Measures|Change from baseline is a dependent variable; the baseline value is a continuous covariate||32 subjects per treatment arm provided 90% power using a 2-sided test at 5% significance.||-8.3|-20.4|<0.0001
71102121|NCT02691494|141712137|SUPERIORITY||Between-Group Difference (%)|84.2|||<|0.001|TWO_SIDED|95.0|75.99|92.37||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|chi-square or Fisher's exact test|||||92.37|75.99|< 0.001
71006821|NCT02274766|141522031|SUPERIORITY||Least Squares Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|0.775||0.0168|TWO_SIDED|95.0|0.35|3.45||Change from Baseline in ON time without troublesome dyskinesia.|Linear Mixed Model w/ Repeated Measures|||||3.45|0.35|0.0168
71006822|NCT02274766|141522031|SUPERIORITY||Least Squares Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.648||0.0853|TWO_SIDED|95.0|-2.42|0.16||Change from Baseline in ON time with troublesome dyskinesia.|Linear Mixed Model w/ Repeated Measures|||||0.16|-2.42|0.0853
71006823|NCT02274766|141522031|SUPERIORITY||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.461||0.0199|TWO_SIDED|95.0|-2.02|-0.18||Change from Baseline in OFF time.|Linear Mixed Model w/ Repeated Measures|||||-0.18|-2.02|0.0199
71006824|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.9||||0.599|TWO_SIDED|95.0|0.39|2.07||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 100ug/placebo for day 7.|||2.07|0.39|0.599
71006825|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.07||||0.442|TWO_SIDED|95.0|0.43|2.59||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 100ug/placebo for day 14.|||2.59|0.43|0.442
71006826|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.68||||0.823|TWO_SIDED|95.0|0.3|1.57||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 200ug/placebo for day 7.|||1.57|0.30|0.823
71006827|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.81||||0.69|TWO_SIDED|95.0|0.33|1.97||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 200ug/placebo for day 14.|||1.97|0.33|0.690
71006828|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.75||||0.764|TWO_SIDED|95.0|0.33|1.71||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 500ug/placebo for day 7.|||1.71|0.33|0.764
71102122|NCT02691494|141712137|SUPERIORITY||Between-Group Difference (%)|56.3|||<|0.001|TWO_SIDED|95.0|47.77|64.91||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|chi-square or Fisher's exact test|||||64.91|47.77|< 0.001
71102123|NCT02691494|141712138|SUPERIORITY||LS Mean of Difference|-252.3|STANDARD_ERROR_OF_MEAN|24.53|<|0.001|TWO_SIDED|||||The P value is from mixed models repeated measures (MMRM) with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
71102124|NCT02691494|141712138|SUPERIORITY||LS Mean of Difference|-226.6|STANDARD_ERROR_OF_MEAN|20.5|<|0.001|TWO_SIDED|||||The P value is from mixed models repeated measures (MMRM) with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
71006829|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.64||||0.841|TWO_SIDED|95.0|0.27|1.56||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 500ug/placebo for day 14.|||1.56|0.27|0.841
71006830|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.81||||0.702|TWO_SIDED|95.0|0.35|1.81||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7.This is the baseline corrected ratio of 100ug/placebo for day 7.|||1.81|0.35|0.702
71006831|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.91||||0.578|TWO_SIDED|95.0|0.33|2.47||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 100ug/placebo for day 14.|||2.47|0.33|0.578
71006832|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.71||||0.783|TWO_SIDED|95.0|0.29|1.7||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7. This is the baseline corrected ratio of 200ug/placebo for day 7.|||1.70|0.29|0.783
71006833|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.64||||0.797|TWO_SIDED|95.0|0.22|1.87||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 200ug/placebo for day 14.|||1.87|0.22|0.797
71006834|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.58||||0.919|TWO_SIDED|95.0|0.27|1.26||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7. This is the baseline corrected ratio of 500ug/placebo for day 7.|||1.26|0.27|0.919
71006835|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.55||||0.892|TWO_SIDED|95.0|0.21|1.43||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 500ug/placebo for day 14.|||1.43|0.21|0.892
71006836|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.47||||0.86|TWO_SIDED|95.0|0.11|1.93||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 100ug/placebo for day 7.|||1.93|0.11|0.860
71006837|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.05||||0.463|TWO_SIDED|95.0|0.38|2.86||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 100ug/placebo for day 14.|||2.86|0.38|0.463
71006838|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.35||||0.932|TWO_SIDED|95.0|0.09|1.42||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 200ug/placebo for day 7.|||1.42|0.09|0.932
71006839|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.43||||0.952|TWO_SIDED|95.0|0.16|1.17||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 200ug/placebo for day 14.|||1.17|0.16|0.952
71006840|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.46||||0.873|TWO_SIDED|95.0|0.12|1.81||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 500ug/placebo for day 7.|||1.81|0.12|0.873
71045198|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|2.07|||<|0.0001|TWO_SIDED|95.0|1.47|2.91|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.91|1.47|<.0001
71006841|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.43||||0.953|TWO_SIDED|95.0|0.16|1.16||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 500ug/placebo for day 14.|||1.16|0.16|0.953
71006842|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio9|1.26||||0.281|TWO_SIDED|95.0|0.56|2.82||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 700ug/placebo for day 7.|||2.82|0.56|0.281
71006843|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.0||||0.5|TWO_SIDED|95.0|0.42|2.35||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 700ug/placebo for day 14.|||2.35|0.42|0.500
71006844|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.76||||0.744|TWO_SIDED|95.0|0.32|1.77||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 1000ug/placebo for day 7.|||1.77|0.32|0.744
71006845|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.21||||0.334|TWO_SIDED|95.0|0.49|3.04||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 1000ug/placebo for day 14.|||3.04|0.49|0.334
71006846|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.81||||0.698|TWO_SIDED|95.0|0.35|1.85||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 2000ug/placebo for day 7.|||1.85|0.35|0.698
71102125|NCT02691494|141712139|SUPERIORITY||LS Mean of Difference|-196.9|STANDARD_ERROR_OF_MEAN|16.66|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
71102126|NCT02691494|141712139|SUPERIORITY||LS Mean of Difference|-186.1|STANDARD_ERROR_OF_MEAN|14.18|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
71102127|NCT02691494|141712140|SUPERIORITY||Between-Group Difference (%)|19.2||||0.146|TWO_SIDED|95.0|-5.99|44.32||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|chi-square or Fisher's exact test|||||44.32|-5.99|0.146
71006847|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.18||||0.353|TWO_SIDED|95.0|0.48|2.88||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 2000ug/placebo for day 14.|||2.88|0.48|0.353
71006848|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio9|1.01||||0.489|TWO_SIDED|95.0|0.45|2.26||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7. This is the baseline corrected ratio of 700ug/placebo for day 7.|||2.26|0.45|0.489
71006849|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.46||||0.94|TWO_SIDED|95.0|0.17|1.23||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 700ug/placebo for day 14.|||1.23|0.17|0.940
71006850|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.01||||0.495|TWO_SIDED|95.0|0.42|2.4||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7. This is the baseline corrected ratio of 1000ug/placebo for day 7.|||2.40|0.42|0.495
71045199|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|1.81||||0.0064|TWO_SIDED|95.0|1.18|2.78|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.78|1.18|0.0064
71045200|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|1.68||||0.018|TWO_SIDED|95.0|1.09|2.58|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.58|1.09|0.0180
70925423|NCT03232138|141344230|EQUIVALENCE|This analysis was focused on the gene set that were found to be upregulated in lung pre-malignant lesions. The objective was to examine if sulforaphane treatment for 12 months would have any significant impact on the expression of these pre-malignant lesions associated upregulated genes in bronchial brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|0.15|STANDARD_ERROR_OF_MEAN|0.15||0.32|TWO_SIDED|||||Hypothesis: Sulforaphane treatment would downregulate these genes whose over-expressions are associated with risk of lung pre-malignant lesions.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after the 12-month sulforaphane treatment.|||||0.32
70925424|NCT03232138|141344231|EQUIVALENCE|This analysis was focused on the gene set that were found to be downregulated in lung pre-malignant lesions. The objective was to examine if sulforaphane treatment for 12 months would have any significant impact on the expression of these pre-malignant lesions associated downregulated genes in bronchial brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.5|TWO_SIDED|||||Hypothesis: Sulforaphane treatment would upregulate these genes whose down-regulated expressions are associated with risk of lung pre-malignant lesions.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after the 12-month sulforaphane treatment.|||||0.5
71006851|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.82||||0.647|TWO_SIDED|95.0|0.28|2.37||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 1000ug/placebo for day 14.|||2.37|0.28|0.647
71006852|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.87||||0.646|TWO_SIDED|95.0|0.4|1.86||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7. This is the baseline corrected ratio of 2000ug/placebo for day 7.|||1.86|0.40|0.646
71006853|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.74||||0.741|TWO_SIDED|95.0|0.29|1.9||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 2000ug/placebo for day 14.|||1.90|0.29|0.741
71006854|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio9|2.18||||0.109|TWO_SIDED|95.0|0.62|7.95||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 700ug/placebo for day 7.|||7.95|0.62|0.109
71006855|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.37||||0.24|TWO_SIDED|95.0|0.55|3.45||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 700ug/placebo for day 14.|||3.45|0.55|0.240
71006856|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.1||||0.447|TWO_SIDED|95.0|0.27|4.44||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 1000ug/placebo for day 7.|||4.44|0.27|0.447
71006857|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.03||||0.472|TWO_SIDED|95.0|0.39|2.74||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 1000ug/placebo for day 14.|||2.74|0.39|0.472
71006858|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.78||||0.698|TWO_SIDED|95.0|0.21|2.9||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 2000ug/placebo for day 7.|||2.90|0.21|0.698
71006859|NCT02130635|141522046|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.53||||0.911|TWO_SIDED|95.0|0.21|1.37||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 2000ug/placebo for day 14.|||1.37|0.21|0.911
71006860|NCT02608892|141522068|SUPERIORITY|Use of pain management during newborn screening was described using frequency and proportion and expressed as an absolute difference in proportions with 95% confidence interval.|Absolute difference in proportions|-7.4|||||TWO_SIDED|95.0|-26.2|11.5||||||||11.5|-26.2|
71006861|NCT02590406|141522072|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||ANOVA|||We calculated our sample size using data from EPO2: PV study (Couture: simultaneous submitted manuscript), where we found a difference in the FRC of 21% between reverse Trendelenburg with non-invasive positive pressure ventilation and beach chair position without positive pressure ventilation. Assuming there would be a difference of 21% in the apnea time, with a type I error of 5% and power of 80%, a total of 17 patients by group was needed.||||0.005
71006862|NCT02590406|141522073|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71006863|NCT02590406|141522074|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||ANOVA|||||||0.0003
71045201|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|5.61||||0.0006|TWO_SIDED|95.0|2.09|15.08|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||15.08|2.09|0.0006
71006864|NCT02590406|141522075|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|||||||ANOVA|||||||0.9
71102128|NCT02691494|141712140|SUPERIORITY||Between-Group Difference (%)|29.2||||0.017|TWO_SIDED|95.0|7.62|50.71||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|chi-square or Fisher's exact test|||||50.71|7.62|0.017
71006865|NCT02590406|141522076|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||ANOVA|||||||0.03
71006866|NCT01628718|141522081|NON_INFERIORITY|The NI margin for CAPS-IV scores was established a priori, based on a calculation of a reliable difference from baseline to posttreatment CAPS-IV scores from a previous trial (10 points). If the 95% confidence interval (CI) around the estimate does not contain the NI margin, we can reject the null hypothesis and accept the alternative hypothesis. .|Mean Difference (Final Values)|0.33||||0.05|TWO_SIDED|95.0|-10.1|9.44||one-tailed|Regression, Linear||Mean difference is the difference in mean CAPS-IV change scores (pre-post) between AD and CPT-C.|Null hypothesis: AD is inferior to CPT Alternative hypothesis: AD is non-inferior to CPT-C||9.44|-10.10|.05
71045202|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|4.46||||0.0034|TWO_SIDED|95.0|1.64|12.13|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||12.13|1.64|0.0034
71045203|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0022|TWO_SIDED|95.0|1.22|2.44|||Regression, Logistic|||Week 16, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.44|1.22|0.0022
71045204|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0014|TWO_SIDED|95.0|1.25|2.5|||Regression, Logistic|||Week 16, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.50|1.25|0.0014
71045205|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|1.87||||0.0003|TWO_SIDED|95.0|1.33|2.64|||Regression, Logistic|||Week 16, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.64|1.33|0.0003
71045206|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|1.68||||0.003|TWO_SIDED|95.0|1.19|2.36|||Regression, Logistic|||Week 16, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.36|1.19|0.0030
71102129|NCT02691494|141712141|SUPERIORITY||LS Mean of Difference|-194.5|STANDARD_ERROR_OF_MEAN|20.56|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
71102130|NCT02691494|141712141|SUPERIORITY||LS Mean of Difference|-125.0|STANDARD_ERROR_OF_MEAN|17.55|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
71102131|NCT00637156|141712142|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.1.|Risk Difference (RD)|0.113||||1|TWO_SIDED|95.0|0.022|0.201||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P(p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.201|0.022|1.000
71045207|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0754|TWO_SIDED|95.0|0.96|2.24|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.24|0.96|0.0754
71045208|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0253|TWO_SIDED|95.0|1.06|2.44|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.44|1.06|0.0253
71045209|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|2.98||||0.0098|TWO_SIDED|95.0|1.3|6.83|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||6.83|1.30|0.0098
71045210|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|1.72||||0.223|TWO_SIDED|95.0|0.72|4.13|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.13|0.72|0.2230
71045211|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|1.5||||0.0201|TWO_SIDED|95.0|1.07|2.12|||Regression, Logistic|||Week 24, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.12|1.07|0.0201
71045212|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|1.73||||0.0021|TWO_SIDED|95.0|1.22|2.44|||Regression, Logistic|||Week 24, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.44|1.22|0.0021
71045213|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0022|TWO_SIDED|95.0|1.22|2.43|||Regression, Logistic|||Week 24, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.43|1.22|0.0022
71006867|NCT02985684|141522088|OTHER|Acceptable performance: favorably exclude PG=0.88 with 95% confidence. Expected 6-month closure success proportion = 0.98. Acceptable performance margin = 0.10. PG = 0.98 - 0.10 = 0.88.|Binomial proportion|1.0|||<|0.0001|ONE_SIDED|95.0|0.974|||A priori 1-sided alpha = 0.05. If test rejects H0, then test primary outcome 2 (clinical success) at 1-sided alpha = 0.05; otherwise testing stops with failure to reject both primary outcome null hypotheses.|Binomial test (exact)||Exact 1-sided confidence interval lower bound from Clopper-Pearson method.|"Test null hypothesis of equal or lesser proportion with 6-month closure success compared to a performance goal (PG).~H0: P ≤ 0.88 vs H1: P \> 0.88, where P is the true proportion of subjects with 6-month closure success and 0.88 is the PG derived from clinical study outcomes for devices indicated for ASD closure.~N=103 subjects provide ≥95% power to exclude PG with 95% confidence if P=0.98 under H1."|||0.974|<0.0001
71006868|NCT02985684|141522089|OTHER|Acceptable performance: favorably exclude PG=0.76 with 95% confidence. Expected 6-month clinical success proportion = 0.88. Acceptable performance margin = 0.12. PG = 0.88 - 0.12 = 0.76.|Binomial proportion|0.9|||<|0.0001|ONE_SIDED|95.0|0.843|||A priori 1-sided alpha = 0.05. If test of primary outcome 1 rejects H0, then test at 1-sided alpha = 0.05; otherwise no testing of this primary outcome and failure to reject null hypothesis.|Binomial test (exact)||Exact 1-sided confidence interval lower bound from Clopper-Pearson method.|"Test null hypothesis of equal or lesser proportion with 6-month clinical success compared to a performance goal (PG).~H0: P ≤ 0.76 vs H1: P \> 0.76, where P is the true proportion of subjects with 6-month clinical success and 0.76 is the PG derived from clinical study outcomes for devices indicated for ASD closure.~N=112 subjects provide 95% power to exclude PG with 95% confidence if P=0.88 under H1."|||0.843|<0.0001
71006869|NCT01436357|141522096|SUPERIORITY||Hazard Ratio (HR)|1.529||||0.317|TWO_SIDED|95.0|0.661|3.535|||Regression, Cox|||||3.535|0.661|0.317
71006870|NCT01436357|141522097|SUPERIORITY||Risk Difference (RD)|0.08||||0.029|TWO_SIDED|95.0|-0.01|0.16|||Fisher Exact|||||0.16|-0.01|0.029
71006871|NCT01436357|141522098|SUPERIORITY||Risk Difference (RD)|0.1||||0.015|TWO_SIDED|95.0|0.01|0.2|||Fisher Exact|||||0.20|0.01|0.015
71006872|NCT01436357|141522099|SUPERIORITY||Risk Difference (RD)|0.0||||0|TWO_SIDED||||||Fisher Exact|||||||0.00
71006873|NCT01436357|141522101|SUPERIORITY||Risk Difference (RD)|0.01||||0.499|TWO_SIDED|95.0|-0.08|0.1|||Fisher Exact|||||0.10|-0.08|0.499
71006874|NCT05281094|141522103|SUPERIORITY||Vaccine Efficacy|12.98|||||TWO_SIDED|95.0|-52.51|50.35|||||. Vaccine efficacy is demonstrated if the lower limit of the 95.0% CI is above 0%.|VE is defined 100% \[1- (λV/λC)\], where λV and λC denote the hazard rates for the HIL-214 and placebo arms respectively, obtained via a stratified Cox proportional hazards model, using Efron's method for handling ties. The model includes a term for vaccine group and was stratified by country, whereby the United States, Dominican Republic, and Puerto Rico were considered one country. The 95% confidence interval as calculated by subtracting the confidence limits of hazard ratio from 1.||50.35|-52.51|
71006875|NCT05281094|141522104|SUPERIORITY||Vaccine Efficacy|17.02|||||TWO_SIDED|95.0|-24.52|44.7|||||Vaccine efficacy is demonstrated if the lower limit of the 95.0% CI is above 0%.|VE is defined 100% \[1- (λV/λC)\], where λV and λC denote the hazard rates for the HIL-214 and placebo arms respectively, obtained via a stratified Cox proportional hazards model, using Efron's method for handling ties. The model includes a term for vaccine group and was stratified by country, whereby the United States, Dominican Republic, and Puerto Rico were considered one country. The 95% confidence interval as calculated by subtracting the confidence limits of hazard ratio from 1||44.70|-24.52|
71102132|NCT00637156|141712142|SUPERIORITY_OR_OTHER|||||||0.993||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of overall success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated. If the posterior probability is at least 0.95, a claim of superiority can be made.||||0.993
71102133|NCT00637156|141712143|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.088||||1|TWO_SIDED|95.0|0.012|0.167||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the NDI success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.167|0.012|1.000
71102134|NCT00637156|141712143|SUPERIORITY_OR_OTHER|||||||0.99||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of NDI success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.990
71006876|NCT05281094|141522105|SUPERIORITY||Vaccine Efficacy|13.91|||||TWO_SIDED|95.0|-34.7|44.98|||||Vaccine efficacy is demonstrated if the lower limit of the 95.0% CI is above 0%.|VE is defined 100% \[1- (λV/λC)\], where λV and λC denote the hazard rates for the HIL-214 and placebo arms respectively, obtained via a stratified Cox proportional hazards model, using Efron's method for handling ties. The model includes a term for vaccine group and was stratified by country, whereby the United States, Dominican Republic, and Puerto Rico were considered one country. The 95% confidence interval as calculated by subtracting the confidence limits of hazard ratio from 1.||44.98|-34.70|
71006877|NCT05281094|141522106|SUPERIORITY||Vaccine Efficacy|-6.37|||||TWO_SIDED|95.0|-45.04|22.0|||||Vaccine efficacy is demonstrated if the lower limit of the 95.0% CI is above 0%.|VE is defined 100% \[1- (λV/λC)\], where λV and λC denote the hazard rates for the HIL-214 and placebo arms respectively, obtained via a stratified Cox proportional hazards model, using Efron's method for handling ties. The model includes a term for vaccine group and was stratified by country, whereby the United States, Dominican Republic, and Puerto Rico were considered one country. The 95% confidence interval as calculated by subtracting the confidence limits of hazard ratio from 1.||22.00|-45.04|
71006878|NCT05315297|141522112|SUPERIORITY|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
71006879|NCT05315297|141522113|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
71006880|NCT05315297|141522114|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
71006881|NCT05315297|141522115|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||||||0.59
71006882|NCT05315297|141522116|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
71006883|NCT05315297|141522117|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
71045214|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|1.87||||0.0004|TWO_SIDED|95.0|1.32|2.64|||Regression, Logistic|||Week 24, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.64|1.32|0.0004
71045215|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|1.32||||0.2031|TWO_SIDED|95.0|0.86|2.01|||Regression, Logistic|||Week 24, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.01|0.86|0.2031
71006884|NCT01432236|141522122|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.61||||0.0001|TWO_SIDED|95.0|-0.91|-0.31||Primary analysis was two-sided and performed at the 0.05 significance level.|Mixed Models Analysis|Satterthwaite's approximation was used to estimate denominator degrees of freedom.||Analysis was done using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.31|-0.91|0.0001
71045216|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|1.44||||0.0867|TWO_SIDED|95.0|0.95|2.18|||Regression, Logistic|||Week 24, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.18|0.95|0.0867
71045217|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|1.8||||0.1746|TWO_SIDED|95.0|0.77|4.22|||Regression, Logistic|||Week 24, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.22|0.77|0.1746
71045218|NCT02709486|141599381|SUPERIORITY||Odds Ratio (OR)|1.99||||0.1039|TWO_SIDED|95.0|0.87|4.57|||Regression, Logistic|||Week 24, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.57|0.87|0.1039
71008688|NCT02055976|141525243|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.663|STANDARD_ERROR_OF_MEAN|1.431|<|0.001|TWO_SIDED|95.0|4.82|10.506|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.506|4.820|<0.001
71045219|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|1.89||||0.0003|TWO_SIDED|95.0|1.33|2.68|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.68|1.33|0.0003
71008689|NCT02055976|141525243|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.29|STANDARD_ERROR_OF_MEAN|1.46|<|0.001|TWO_SIDED|95.0|6.389|12.19|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||12.190|6.389|<0.001
71008690|NCT02055976|141525243|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.255|STANDARD_ERROR_OF_MEAN|1.47|<|0.001|TWO_SIDED|95.0|4.336|10.175|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.175|4.336|<0.001
71008691|NCT02055976|141525243|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.228|STANDARD_ERROR_OF_MEAN|1.806||0.11|TWO_SIDED|95.0|-1.361|5.818|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||5.818|-1.361|0.110
71008692|NCT02055976|141525243|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.578|STANDARD_ERROR_OF_MEAN|1.815||0.001|TWO_SIDED|95.0|1.972|9.185|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.185|1.972|0.001
71008693|NCT02055976|141525243|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.712|STANDARD_ERROR_OF_MEAN|1.789||0.005|TWO_SIDED|95.0|1.156|8.268|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||8.268|1.156|0.005
71045220|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0286|TWO_SIDED|95.0|1.04|2.1|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.10|1.04|0.0286
71102135|NCT00637156|141712144|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.05||||1|TWO_SIDED|95.0|-0.014|0.119||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the neurological success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.119|-0.014|1.000
71102136|NCT00637156|141712144|SUPERIORITY_OR_OTHER|||||||0.931||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of neurological success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.931
71102137|NCT00637156|141712145|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.021||||1|TWO_SIDED|95.0|-0.019|0.062||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the neck pain success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.062|-0.019|1.000
71102138|NCT00637156|141712145|SUPERIORITY_OR_OTHER|||||||0.852||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of neck pain success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.852
71045221|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|1.45||||0.1031|TWO_SIDED|95.0|0.93|2.27|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.27|0.93|0.1031
71006885|NCT01432236|141522124|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.6|||<|0.0001|TWO_SIDED|95.0|-9.33|-3.87||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the FIQ total score. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-3.87|-9.33|<0.0001
71006886|NCT01432236|141522124|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.42||||0.0078|TWO_SIDED|95.0|-0.74|-0.11||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for parameter 'physical impairment'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.11|-0.74|0.0078
71006887|NCT01432236|141522124|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85||||0.0014|TWO_SIDED|95.0|-1.36|-0.33||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'feel good'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.33|-1.36|0.0014
71102139|NCT00637156|141712146|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.008||||0.997|TWO_SIDED|95.0|-0.073|0.056||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the arm pain success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.056|-0.073|0.997
71006888|NCT01432236|141522124|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59||||0.005|TWO_SIDED|95.0|-1.01|-0.18||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above for parameter 'work missed'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.18|-1.01|0.0050
71006889|NCT01432236|141522124|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75||||0.0002|TWO_SIDED|95.0|-1.14|-0.36||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'do work'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.36|-1.14|0.0002
71006890|NCT01432236|141522124|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64||||0.0006|TWO_SIDED|95.0|-1.0|-0.28||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'pain'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.28|-1.00|0.0006
71102140|NCT00637156|141712146|SUPERIORITY_OR_OTHER|||||||0.395||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of arm pain success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.395
71102141|NCT00637156|141712147|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.024||||1|TWO_SIDED|95.0|-0.042|0.088||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the SF-36 PCS success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.088|-0.042|1.000
71102142|NCT00637156|141712147|SUPERIORITY_OR_OTHER|||||||0.767||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of SF-36 PCS success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.767
71102143|NCT00637156|141712148|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.024||||0.945|TWO_SIDED|95.0|-0.12|0.067||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the SF-36 MCS success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.067|-0.120|0.945
71008694|NCT02055976|141525243|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.888|STANDARD_ERROR_OF_MEAN|2.035||0.002|TWO_SIDED|95.0|1.844|9.932|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.932|1.844|0.002
70925425|NCT03232138|141344232|EQUIVALENCE|This analysis was focused on the gene set that were found to be upregulated in lung cancer. The objective was to examine if sulforaphane treatment for 12 months had any significant impact on the expression of these lung-cancer associated upregulated genes in nasal brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|-0.27|STANDARD_ERROR_OF_MEAN|0.1||0.012|TWO_SIDED|||||Sulforaphane treatment would downregulate the expression of these genes whose upregulated expressions in bronchial epithelial cells have been found to be associated with risk of lung cancer.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after the 12-month sulforaphane treatment.|||||0.012
71006891|NCT01432236|141522124|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44||||0.0315|TWO_SIDED|95.0|-0.85|-0.04||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'fatigue'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.04|-0.85|0.0315
71006892|NCT01432236|141522124|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.76||||0.0003|TWO_SIDED|95.0|-1.17|-0.35||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'rested'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.35|-1.17|0.0003
71006893|NCT01432236|141522124|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.71||||0.0007|TWO_SIDED|95.0|-1.11|-0.31||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'stiffness'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.31|-1.11|0.0007
71006894|NCT01432236|141522124|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55||||0.0048|TWO_SIDED|95.0|-0.93|-0.17||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'anxiety'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.17|-0.93|0.0048
71045222|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|1.34||||0.2033|TWO_SIDED|95.0|0.85|2.1|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.10|0.85|0.2033
71045223|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|2.8||||0.0064|TWO_SIDED|95.0|1.34|5.86|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||5.86|1.34|0.0064
71045224|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|1.44||||0.3706|TWO_SIDED|95.0|0.65|3.23|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.23|0.65|0.3706
71102144|NCT00637156|141712149|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.017||||0.997|TWO_SIDED|95.0|-0.072|0.04||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the FSU success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.040|-0.072|0.997
71102145|NCT00637156|141712149|SUPERIORITY_OR_OTHER|||||||0.271||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of FSU success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.271
71102146|NCT00637156|141712150|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.013||||1|TWO_SIDED|95.0|-0.013|0.04||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the gait success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.040|-0.013|1.000
71102147|NCT00637156|141712150|SUPERIORITY_OR_OTHER|||||||0.859||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of gait success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.859
71006895|NCT01432236|141522124|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.32|-0.53||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'depression'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.53|-1.32|<0.0001
71006896|NCT01432236|141522125|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0637|TWO_SIDED|||||This analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Cochran-Mantel-Haenszel|||The PGIC variable was analyzed using Cochran Mantel-Haenszel (CMH) test with modified ridit transformation.||||0.0637
71006897|NCT01432236|141522126|SUPERIORITY_OR_OTHER_LEGACY|||||||0.116|TWO_SIDED|||||This analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Cochran-Mantel-Haenszel|||The PGIC variable was analyzed using CMH test with modified ridit transformation.||||0.1160
71006898|NCT01432236|141522127|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007|TWO_SIDED|||||This secondary analyses was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Regression, Logistic|||Statistical analysis presented above is for 30% responders. Analysis was conducted using a logistic regression model using sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors. Logit link transformation was used for the model.||||0.0007
71006899|NCT01432236|141522127|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0205|TWO_SIDED|||||This secondary analyses was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Regression, Logistic|||Statistical analysis presented above is for 50% responders. Analysis was conducted using a logistic regression model using sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors. Logit link transformation was used for the model.||||0.0205
71102148|NCT00637156|141712151|SUPERIORITY_OR_OTHER||Posterior Mean Difference|0.4||||0|TWO_SIDED|95.0|0.252|0.548||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean difference (µ1- µ0) and the corresponding 95% highest posterior density (HPD) interval were presented instead of the usual 95% CI.|"Superiority comparison of the operative time in two treatment groups was assessed. The null hypothesis is H0: μ1 = μ0 and the alternative hypothesis is Ha: μ1 ≠ μ0, where μ0 and μ1 denote the mean in control group the investigational group, respectively. Should the posterior probability of superiority P(μ1- μ0 \< 0\|data) be at least 97.5%, the superiority would be claimed."||0.548|0.252|0.0
71006900|NCT01432236|141522128|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.57|||<|0.0001|TWO_SIDED|95.0|0.31|0.84||This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-subject error as random factors.||0.84|0.31|<0.0001
71006901|NCT01432236|141522129|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.81||||0.0018|TWO_SIDED|95.0|-12.66|-2.96||This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-2.96|-12.66|0.0018
71006902|NCT01432236|141522130|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.8||||0.0117|TWO_SIDED|95.0|-10.29|-1.31||This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors||-1.31|-10.29|0.0117
71006903|NCT01432236|141522131|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.35||||0.0511|TWO_SIDED|95.0|-0.04|16.74||This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||16.74|-0.04|0.0511
71006904|NCT01432236|141522132|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13||||0.1139|TWO_SIDED|95.0|-0.29|0.03||This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors. Analyzed as a count variable using a generalized linear model assuming a Poisson distribution and utilizing a log link transformation.||0.03|-0.29|0.1139
71008695|NCT02055976|141525243|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.251|STANDARD_ERROR_OF_MEAN|2.062|<|0.001|TWO_SIDED|95.0|5.153|13.349|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||13.349|5.153|<0.001
71006905|NCT01432236|141522134|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.95|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.5||Two-sided test with α=0.05 was used. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analysis presented in the above table is for HADS-A (anxiety). Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.50|-1.40|<0.0001
71006906|NCT01432236|141522134|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.88||||0.0005|TWO_SIDED|95.0|-1.37|-0.39||Two-sided test with α=0.05 was used. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analysis presented in the above table is for HADS-D (depression). Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and subject within sequence and within-subject error as random factors.||-0.39|-1.37|0.0005
71006907|NCT01432236|141522136|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.3854|TWO_SIDED|95.0|-0.02|0.06||Two-sided test with α=0.05 was used. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||0.06|-0.02|0.3854
71006908|NCT01432236|141522138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.55||||0.0085|TWO_SIDED|95.0|0.14|0.97||Two-sided test with α=0.05 was used. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||0.97|0.14|0.0085
71006909|NCT04607291|141522145|OTHER|A logistic regression model was used to identify factors associated with screening.|||||||||||||||||"A logistic regression model was used to identify factors associated with screening. A stepwise selection procedure (alpha entry and alpha exit = 0.15) was used to determine what factors were included in the model. Overall performance is assessed using the AUC.~Factors included in the model: sex, stool test recommended by physician, know where to get stool test, fear of colonoscopy index score, ABR - afraid score, and knowledge that colonoscopy can reduce worry.~AUC: 0.71"|||
71006910|NCT04607291|141522146|OTHER|A logistic regression model was used to identify characteristics associated with high intent of getting a Fit test.||||||||||||||||Evaluating factors associated with high intent of getting a Fit test.|"A logistic regression model was used to identify factors associated with high intent of getting a fit test. A stepwise selection procedure (alpha entry and alpha exit = 0.15) was used to determine what factors were included in the model. Overall performance is assessed using the AUC.~Factors included in the model: sex, race, stool test or colonoscopy recommended by physician, know where to get stool test, CBPR score, and barriers to screening score.~AUC: 0.80"|||
71006911|NCT03350724|141522147|SUPERIORITY|||||||0.039||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.039
71006912|NCT03350724|141522148|SUPERIORITY|||||||0.037||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.037
71006913|NCT03350724|141522149|SUPERIORITY|||||||0.032|||||||Z-Test for Two Population Proportions|||||||0.032
71006914|NCT03350724|141522150|SUPERIORITY|||||||0.171||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.171
71102149|NCT00637156|141712152|SUPERIORITY_OR_OTHER||Posterior Mean Difference|11.5||||0.02|TWO_SIDED|95.0|0.56|22.44|||Bayesian model||The posterior mean difference (µ1- µ0) and the corresponding 95% highest posterior density (HPD) interval were presented instead of the usual 95% CI.|"Superiority comparison of the blood loss in two treatment groups was assessed.The null hypothesis is H0: μ1 = μ0 and the alternative hypothesis is Ha: μ1 ≠ μ0, where μ0 and μ1 denote the mean in control group the investigational group, respectively. Should the posterior probability of superiority P(μ1- μ0 \< 0\|data) be at least 97.5%, the superiority would be claimed."||22.440|0.560|0.02
71102150|NCT00637156|141712153|SUPERIORITY_OR_OTHER||Posterior Mean Difference|-0.1||||0.892|TWO_SIDED|95.0|-0.258|0.058||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean difference (µ1- µ0) and the corresponding 95% highest posterior density (HPD) interval were presented instead of the usual 95% CI.|"Superiority comparison of the hospital stay in two treatment groups was assessed.The null hypothesis is H0: μ1 = μ0 and the alternative hypothesis is Ha: μ1 ≠ μ0, where μ0 and μ1 denote the mean in control group the investigational group, respectively. Should the posterior probability of superiority P(μ1- μ0 \< 0\|data) be at least 97.5%, the superiority would be claimed."||0.058|-0.258|0.892
71102151|NCT04632030|141712201|OTHER||Odds Ratio (OR)|1.58|||||TWO_SIDED|95.0|0.69|3.6|||||Adjusted for age, education, and lifetime tobacco use|||3.6|.69|
71006915|NCT03350724|141522151|SUPERIORITY|||||||0.484||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.484
71006916|NCT03350724|141522152|SUPERIORITY|||||||0.368||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.368
71006917|NCT03350724|141522153|SUPERIORITY|||||||0.308||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.308
71006918|NCT03350724|141522154|SUPERIORITY|||||||0.999||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.999
71006919|NCT03350724|141522155|SUPERIORITY|||||||0.015||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.015
71006920|NCT03350724|141522156|SUPERIORITY|||||||0.021||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.021
71006921|NCT03350724|141522157|SUPERIORITY|||||||0.035||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.035
71006922|NCT03350724|141522158|SUPERIORITY|||||||0.444||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.444
71006923|NCT03350724|141522159|SUPERIORITY|||||||0.765||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.765
71006924|NCT03350724|141522160|SUPERIORITY|||||||0.941||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.941
71102152|NCT04632030|141712201|OTHER||Odds Ratio (OR)|2.89|||||TWO_SIDED|95.0|1.28|6.55|||||Adjusted for age, education, and lifetime tobacco use|||6.55|1.28|
71102153|NCT04632030|141712202|OTHER||Odds Ratio (OR)|2.88|||||TWO_SIDED|95.0|1.28|6.47|||||Adjusted for age, education, and lifetime tobacco use|||6.47|1.28|
71006925|NCT03350724|141522161|SUPERIORITY|||||||0.421||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.421
71006926|NCT03350724|141522162|SUPERIORITY|||||||0.357||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.357
71006927|NCT03350724|141522163|SUPERIORITY|||||||0.22||||||Unadjusted p-value|Paired t-Test|Unadjusted p-value||||||0.22
71006928|NCT03350724|141522164|SUPERIORITY|||||||0.882||||||Unadjusted p-value|Paired t-Test|Unadjusted p-value||||||0.882
71006929|NCT03350724|141522165|SUPERIORITY|||||||0.64||||||Unadjusted p-value|Paired t-Test|Unadjusted p-value||||||0.64
71102154|NCT04632030|141712202|OTHER||Odds Ratio (OR)|2.87|||||TWO_SIDED|95.0|1.26|6.5|||||Adjusted for age, education, and lifetime tobacco use|||6.50|1.26|
71006930|NCT03350724|141522166|SUPERIORITY|||||||0.967||||||Unadjusted p-value|Paired t-Test|Unadjusted p-value||||||0.967
71006931|NCT03350724|141522167|SUPERIORITY|||||||0.375||||||Unadjusted p-value|Paired t-Test|Unadjusted p-value||||||0.375
71006932|NCT02759939|141522178|SUPERIORITY||Odds Ratio (OR)|1.23||||0.8|TWO_SIDED|||||Adjusted for multiple comparisons using the Scheffe method|See below|Random effects logistic regression with a random intercept for clinic and adjustment for participant characteristics that differed across trial arms||||||0.80
71006933|NCT02759939|141522178|SUPERIORITY||Odds Ratio (OR)|1.47||||0.32|TWO_SIDED|||||Adjusted for multiple comparisons using the Scheffe method|See below|Random effects logistic regression with a random intercept for clinic and adjustment for participant characteristics that differed across trial arms||||||0.32
71006934|NCT02759939|141522178|SUPERIORITY||Odds Ratio (OR)|0.95||||0.99|TWO_SIDED|||||Adjusted for multiple comparisons using the Scheffe method|See below|Random effects logistic regression with a random intercept for clinic and adjustment for participant characteristics that differed across trial arms||||||0.99
71006935|NCT02759939|141522178|SUPERIORITY||Odds Ratio (OR)|0.8||||0.72|TWO_SIDED|||||Adjusted for multiple comparisons using the Scheffe method|See below|Random effects logistic regression with a random intercept for clinic and adjustment for participant characteristics that differed across trial arms||||||0.72
71006936|NCT03288987|141522199|NON_INFERIORITY|Noninferiority was declared by comparing the 90% CI for the hazard ratio (HR) of the AryoGen Pharmed Bevacizumab to the reference product (Roche Bevacizumab) to the point-estimate margin and was based on the synthesis method.|Hazard Ratio (HR)|0.79||||0.47|TWO_SIDED|90.0|0.46|1.35|||Regression, Cox|Upper limit of CI is lower than the noninferiority margin (1.44).|The 90 % CI based on synthesis method is (0.45,1.38). In HR calculation, the AryoGen Pharmed Bevacizumab to Roche Bevacizumab was reported. (reference group was Roche Bevacizumab)|||1.35|0.46|0.47
71102155|NCT04632030|141712203|OTHER||Odds Ratio (OR)|1.51|||||TWO_SIDED|95.0|0.59|3.86|||||Adjusted for age, education, and lifetime tobacco use|||3.86|.59|
71102156|NCT04632030|141712203|OTHER||Odds Ratio (OR)|1.85|||||TWO_SIDED|95.0|0.73|4.67|||||Adjusted for age, education, and lifetime tobacco use|||4.67|.73|
71102157|NCT04632030|141712204|OTHER||Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.53|2.99|||||Adjusted for age, education, and lifetime tobacco use|||2.99|.53|
71102158|NCT04632030|141712204|OTHER||Odds Ratio (OR)|2.19|||||TWO_SIDED|95.0|0.94|5.13|||||Adjusted for age, education, and lifetime tobacco use|||5.13|.94|
70925426|NCT03232138|141344233|EQUIVALENCE|This analysis was focused on the gene set that were found to be downregulated in lung cancer. The objective was to examine if sulforaphane treatment for 12 months had any significant impact on the expression of these lung-cancer associated upregulated genes in nasal brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|0.38|STANDARD_ERROR_OF_MEAN|0.12||0.0045|TWO_SIDED|||||Hypothesis: Sulforaphane treatment would upregulate the expression of these genes whose downregulated expressions in nasal epithelial cells have been found to be associated with risk of lung cancer.|Mixed Models Analysis||Changes (beta) of gene expression after the 12-month sulforaphane treatment.|||||0.0045
70925427|NCT03232138|141344234|EQUIVALENCE|This analysis was focused on the gene set that were found to be upregulated in lung premalignant lesions. The objective was to examine if sulforaphane treatment for 12 months had any significant impact on the expression of these premalignant lesion-associated upregulated genes in nasal brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|0.17|STANDARD_ERROR_OF_MEAN|0.16||0.32|TWO_SIDED|||||Hypothesis: Sulforaphane treatment would downregulate the expression of these genes whose upregulated expressions in bronchial epithelial cells have been found to be associated with risk of lung premalignant lesions.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after the 12-month sulforaphane treatment.|||||0.32
71006937|NCT03288987|141522200|OTHER||Hazard Ratio (HR)|0.99||||0.99|TWO_SIDED|95.0|0.55|1.8|||Regression, Cox||In HR calculation, the AryoGen Pharmed Bevacizumab to Roche Bevacizumab was reported. (reference group was Roche Bevacizumab)|||1.80|0.55|0.99
71006938|NCT03288987|141522201|OTHER|||||||0.17|||||||Fisher's Exact Test|||||||0.17
71006939|NCT03288987|141522202|OTHER||Hazard Ratio (HR)|1.11||||0.59|TWO_SIDED|95.0|0.76|1.61|||Regression, Cox||In HR calculation, the AryoGen Pharmed Bevacizumab to Roche Bevacizumab was reported. (reference group was Roche Bevacizumab)|||1.61|0.76|0.59
71006940|NCT03288987|141522203|OTHER||||||>|0.05|||||||Fisher's Exact Test|||||||>0.05
71006941|NCT04652102|141522222|SUPERIORITY||Proportion|0.364|||||TWO_SIDED|95.826|0.299|0.433|||||Derived from an exact 2-sided 95.826% Pearson-Clopper confidence interval (CI) on proportion of cases coming from the CVnCoV group among all cases.|Proportion of cases coming from the CVnCoV group among all cases.||0.433|0.299|
71006942|NCT04652102|141522222|OTHER||Vaccine Efficacy|48.2||||0.016|TWO_SIDED|95.826|31.0|61.4||1-sided p-value from the exact binomial test on proportion of cases coming from the CVnCoV group among all cases (equivalent to a test on VE with H0: VE ≤30%). Statistically significant if lower than 0.02087.|Exact Binomial Test||2-sided 95.826% CI on VE, derived from the exact 2-sided 95.826% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|Vaccine efficacy (VE) calculated as VE = 1 - p/(1-p) \*1/r where p represents the proportion of cases coming from the CVnCoV group among all cases and r represents the ratio of total follow-up time of subjects in the CVnCoV group over the total follow-up time of subjects in the placebo group.||61.4|31.0|0.01600
71006943|NCT04652102|141522234|SUPERIORITY||Proportion|0.245|||||TWO_SIDED|95.0|0.133|0.389|||||Derived from an exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|Proportion of cases coming from the CVnCoV group among all cases.||0.389|0.133|
71006944|NCT04652102|141522234|SUPERIORITY||Vaccine Efficacy|70.7|||||TWO_SIDED|95.0|42.5|86.1|||||2-sided 95% CI on VE, derived from the exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|VE calculated as VE = 1 - p/(1-p) \*1/r where p represents the proportion of cases coming from the CVnCoV group among all cases and r represents the ratio of total follow-up time of subjects in the CVnCoV group over the total follow-up time of subjects in the placebo group.||86.1|42.5|
71006945|NCT04652102|141522235|SUPERIORITY||Proportion|0.286|||||TWO_SIDED|95.0|0.084|0.581|||||Derived from an exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|Proportion of cases coming from the CVnCoV group among all cases.||0.581|0.084|
71045225|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|2.39||||0.2121|TWO_SIDED|95.0|0.61|9.41|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||9.41|0.61|0.2121
71006946|NCT04652102|141522235|SUPERIORITY||Vaccine Efficacy|63.8|||||TWO_SIDED|95.0|-25.5|91.7|||||2-sided 95% CI on VE, derived from the exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|VE calculated as VE = 1 - p/(1-p) \*1/r where p represents the proportion of cases coming from the CVnCoV group among all cases and r represents the ratio of total follow-up time of subjects in the CVnCoV group over the total follow-up time of subjects in the placebo group.||91.7|-25.5|
71045226|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|1.67||||0.4859|TWO_SIDED|95.0|0.39|7.11|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||7.11|0.39|0.4859
71102159|NCT00964678|141712205|SUPERIORITY|||||||0.028|TWO_SIDED|20.0||||The threshold for statistical significance was p=0.05.|ANOVA|||||||0.028
71045227|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|2.25|||<|0.0001|TWO_SIDED|95.0|1.6|3.17|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.17|1.60|<.0001
71102160|NCT00964678|141712206|SUPERIORITY|||||||0.028||||||The threshold for statistical significance was p=0.05.|ANOVA|||||||0.028
71102161|NCT00964678|141712207|SUPERIORITY||||||>|0.05|TWO_SIDED|20.0||||The threshold for statistical significance was p=0.05.|ANOVA|||||||>0.05
71102162|NCT00964678|141712208|SUPERIORITY||||||>|0.05|TWO_SIDED|20.0|||||ANOVA|||||||>0.05
71006947|NCT04652102|141522236|SUPERIORITY||Proportion|0.341|||||TWO_SIDED|95.0|0.242|0.452|||||Derived from an exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|Proportion of cases coming from the CVnCoV group among all cases.||0.452|0.242|
71006948|NCT04652102|141522236|SUPERIORITY||Vaccine Efficacy|53.2|||||TWO_SIDED|95.0|25.4|71.2|||||2-sided 95% CI on VE, derived from the exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|VE calculated as VE = 1 - p/(1-p) \*1/r where p represents the proportion of cases coming from the CVnCoV group among all cases and r represents the ratio of total follow-up time of subjects in the CVnCoV group over the total follow-up time of subjects in the placebo group.||71.2|25.4|
71006949|NCT04652102|141522237|SUPERIORITY||Proportion|0.571|||||TWO_SIDED|95.0|0.34|0.782|||||Derived from an exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|Proportion of cases coming from the CVnCoV group among all cases.||0.782|0.340|
71006950|NCT04652102|141522237|SUPERIORITY||Vaccine Efficacy|-11.8|||||TWO_SIDED|95.0|-200.5|56.7|||||2-sided 95% CI on VE, derived from the exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|VE calculated as VE = 1 - p/(1-p) \*1/r where p represents the proportion of cases coming from the CVnCoV group among all cases and r represents the ratio of total follow-up time of subjects in the CVnCoV group over the total follow-up time of subjects in the placebo group.||56.7|-200.5|
71006951|NCT00696774|141522249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.005|TWO_SIDED|95.0|-1.12|-0.2|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-0.20|-1.12|0.005
71006952|NCT00696774|141522251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.85|||||TWO_SIDED|95.0|-7.34|-4.36|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-4.36|-7.34|
71006953|NCT00696774|141522252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.47|||||TWO_SIDED|95.0|-3.13|-1.81|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-1.81|-3.13|
71006954|NCT00696774|141522253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.29|||||TWO_SIDED|95.0|-4.1|-2.48|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-2.48|-4.10|
71006955|NCT00696774|141522254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.22|||||TWO_SIDED|95.0|-2.89|-1.54|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-1.54|-2.89|
71006956|NCT00696774|141522255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88|||||TWO_SIDED|95.0|-2.45|-1.3|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-1.30|-2.45|
71045228|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|2.1|||<|0.0001|TWO_SIDED|95.0|1.5|2.96|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.96|1.50|<.0001
71006957|NCT00696774|141522256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|||||TWO_SIDED|95.0|-1.31|-0.63|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-0.63|-1.31|
71006958|NCT00696774|141522257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.42|||||TWO_SIDED|95.0|-6.04|-2.8|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-2.80|-6.04|
71006959|NCT00696774|141522258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13|||||TWO_SIDED|95.0|-1.42|-0.84|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-0.84|-1.42|
71006960|NCT00696774|141522259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||||TWO_SIDED|95.0|-1.08|-0.24|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-0.24|-1.08|
71006961|NCT00696774|141522260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|||||TWO_SIDED|95.0|-0.81|-0.18|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-0.18|-0.81|
71045229|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|1.91||||0.002|TWO_SIDED|95.0|1.27|2.87|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.87|1.27|0.0020
71045230|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|2.28|||<|0.0001|TWO_SIDED|95.0|1.53|3.4|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.40|1.53|<.0001
71006962|NCT00696774|141522261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81|||||TWO_SIDED|95.0|-0.99|2.6|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|Week 4||2.60|-0.99|
71006963|NCT00696774|141522261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.36|||||TWO_SIDED|95.0|-0.69|3.42|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|Week 8||3.42|-0.69|
71006964|NCT00696774|141522262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.05|||||TWO_SIDED|95.0|10.63|19.47|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|Week 4||19.47|10.63|
71006965|NCT00696774|141522262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.48|||||TWO_SIDED|95.0|4.72|16.24|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|Week 8||16.24|4.72|
71006966|NCT00696774|141522263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.88|||||TWO_SIDED|95.0|-7.75|-4.02|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|Week 4||-4.02|-7.75|
71006967|NCT00696774|141522263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.59|||||TWO_SIDED|95.0|-6.65|-2.54|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|Week 8||-2.54|-6.65|
71006968|NCT02442765|141522278|SUPERIORITY||Least Squares Mean Difference|-4.0|||=|0.021|TWO_SIDED|95.0|-7.4|-0.6||MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use. Unstructured variance-covariance was used.|mixed model repeated measures (MMRM)|||||-0.6|-7.4|=0.021
71006969|NCT02442765|141522278|SUPERIORITY||Least Squares Mean Difference|-0.6|||=|0.731|TWO_SIDED|95.0|-3.9|2.7||MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use. Unstructured variance-covariance was used.|MMRM|||||2.7|-3.9|=0.731
71006970|NCT02442765|141522278|SUPERIORITY||Least Squares Mean Difference|-3.5|||=|0.157|TWO_SIDED|95.0|-8.4|1.4||MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use. Unstructured variance-covariance was used.|MMRM|||||1.4|-8.4|=0.157
71006971|NCT02442765|141522278|SUPERIORITY||Least Squares Mean Difference|-3.6|||=|0.15|TWO_SIDED|95.0|-8.4|1.3||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||1.3|-8.4|=0.150
71006972|NCT02442765|141522278|SUPERIORITY||MMRM weighted z-statistic|-2.65|||=|0.008|TWO_SIDED|||||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|Sequential Parallel Comparison Design (SPCD) was used with weight = 0.6 for Stage 1 and 0.4 for Stage 2.||||||=0.008
71006973|NCT02442765|141522278|SUPERIORITY||MMRM weighted z-statistic|-1.26|||=|0.208|TWO_SIDED|||||MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use. Unstructured variance-covariance was used.|MMRM|SPCD was used with weight = 0.6 for Stage 1 and 0.4 for Stage 2.||||||=0.208
71006974|NCT02442765|141522279|SUPERIORITY||Least Squares Mean Difference|-0.1||||0.331|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.331
71006975|NCT02442765|141522279|SUPERIORITY||Least Squares Mean Difference|-0.1||||0.4|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||||0.2|-0.4|0.400
71006976|NCT02442765|141522279|SUPERIORITY||Least Squares Mean Difference|-0.6||||0.014|TWO_SIDED|95.0|-1.1|-0.1|||ANCOVA|||||-0.1|-1.1|0.014
71006977|NCT02442765|141522279|SUPERIORITY||Least Squares Mean Difference|-0.4||||0.145|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||||0.1|-0.9|0.145
71006978|NCT02442765|141522279|SUPERIORITY||SPCD OLS weighted z-statistic|-2.51||||0.012|TWO_SIDED||||||ANCOVA||OLS = ordinary least squares|||||0.012
71006979|NCT02442765|141522279|SUPERIORITY||SPCD OLS weighted z-statistic|-1.66||||0.097|TWO_SIDED||||||ANCOVA|||||||0.097
71006980|NCT02442765|141522280|SUPERIORITY||Least Squares Mean Difference|-0.5|||=|0.182|TWO_SIDED|95.0|-1.3|0.2||MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use. Unstructured variance-covariance was used.|MMRM|SPCD was used with weight = 0.6 for Stage 1 and 0.4 for Stage 2.||||0.2|-1.3|=0.182
71006981|NCT02442765|141522280|SUPERIORITY||Least Squares Mean Difference|-0.3|||=|0.39|TWO_SIDED|95.0|-1.1|0.4||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.4|-1.1|=0.390
71006982|NCT02442765|141522280|SUPERIORITY||Least Squares Mean Difference|0.5|||=|0.462|TWO_SIDED|95.0|-0.8|1.7||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||1.7|-0.8|=0.462
71102163|NCT00561821|141712246|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71102164|NCT00561821|141712246|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71102165|NCT00561821|141712246|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71006983|NCT02442765|141522280|SUPERIORITY||Least Squares Mean Difference|0.4|||=|0.528|TWO_SIDED|95.0|-0.8|1.6||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||1.6|-0.8|=0.528
71006984|NCT02442765|141522280|SUPERIORITY||MMRM weighted z-statistic|-0.39|||=|0.695|TWO_SIDED|||||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, Baseline (BL), BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|ANCOVA|||||||=0.695
71006985|NCT02442765|141522280|SUPERIORITY||MMRM weighted z-statistic|-0.12|||=|0.904|TWO_SIDED|||||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, Baseline (BL), BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|ANCOVA|||||||=0.904
71006986|NCT02442765|141522281|SUPERIORITY||Least Squares Mean Difference|-1.2|||=|0.247|TWO_SIDED|95.0|-3.2|0.8||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.8|-3.2|=0.247
71006987|NCT02442765|141522281|SUPERIORITY||Least Squares Mean Difference|-0.4|||=|0.721|TWO_SIDED|95.0|-2.3|1.6||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||1.6|-2.3|=0.721
71006988|NCT02442765|141522281|SUPERIORITY||Least Squares Mean Difference|-1.2|||=|0.419|TWO_SIDED|95.0|-4.3|1.8||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||1.8|-4.3|=0.419
71006989|NCT02442765|141522281|SUPERIORITY||Least Squares Mean Difference|0.9|||=|0.534|TWO_SIDED|95.0|-2.0|3.9||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||3.9|-2.0|=0.534
71006990|NCT02442765|141522281|SUPERIORITY||MMRM weighted z-statistic|-1.4|||=|0.163|TWO_SIDED||||||ANCOVA|||||||=0.163
71006991|NCT02442765|141522281|SUPERIORITY||MMRM weighted z-statistic|0.19|||=|0.851|TWO_SIDED||||||ANCOVA|||||||=0.851
71102166|NCT00561821|141712247|SUPERIORITY_OR_OTHER|||||||0.0146||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0146
71006992|NCT02442765|141522282|SUPERIORITY||Least Squares Mean Difference|-0.6|||=|0.146|TWO_SIDED|95.0|-1.4|0.2||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.2|-1.4|=0.146
71006993|NCT02442765|141522282|SUPERIORITY||Least Squares Mean Difference|0.3|||=|0.399|TWO_SIDED|95.0|-0.4|1.1||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||1.1|-0.4|=0.399
71006994|NCT02442765|141522282|SUPERIORITY||Least Squares Mean Difference|0.7|||=|0.283|TWO_SIDED|95.0|-0.6|2.0||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||2.0|-0.6|=0.283
71006995|NCT02442765|141522282|SUPERIORITY||Least Squares Mean Difference|1.2|||=|0.065|TWO_SIDED|95.0|-0.1|2.5||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||2.5|-0.1|=0.065
71006996|NCT02442765|141522282|SUPERIORITY||MMRM weighted z-statistic|-0.22|||=|0.829|TWO_SIDED||||||ANCOVA|||||||=0.829
71006997|NCT02442765|141522282|SUPERIORITY||MMRM weighted z-statistic|1.94|||=|0.052|TWO_SIDED||||||ANCOVA|||||||=0.052
71006998|NCT02442765|141522283|SUPERIORITY||Least Squares Mean Difference|-0.7|||=|0.53|TWO_SIDED|95.0|-2.7|1.4|||ANCOVA|||||1.4|-2.7|=0.530
71006999|NCT02442765|141522283|SUPERIORITY||Least Squares Mean Difference|-1.0|||=|0.326|TWO_SIDED|95.0|-3.1|1.0|||ANCOVA|||||1.0|-3.1|=0.326
71007000|NCT02442765|141522283|SUPERIORITY||Least Squares Mean Difference|2.5|||=|0.135|TWO_SIDED|95.0|-0.8|5.9|||ANCOVA|||||5.9|-0.8|=0.135
71007001|NCT02442765|141522283|SUPERIORITY||Least Squares Mean Difference|0.2|||=|0.895|TWO_SIDED|95.0|-3.1|3.5|||ANCOVA|||||3.5|-3.1|=0.895
71007002|NCT02442765|141522283|SUPERIORITY||SPCD OLS weighted Z-statistic|0.67|||=|0.502|TWO_SIDED||||||ANCOVA|||||||=0.502
71007003|NCT02442765|141522283|SUPERIORITY||SPCD OLS weighted Z-statistic|-0.58|||=|0.564|TWO_SIDED||||||ANCOVA|||||||=0.564
71007004|NCT02442765|141522284|SUPERIORITY||Least Squares Mean Difference|-0.8|||=|0.061|TWO_SIDED|95.0|-1.6|0.0||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.0|-1.6|=0.061
71102167|NCT00561821|141712247|SUPERIORITY_OR_OTHER|||||||0.0234||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0234
71102168|NCT00561821|141712247|SUPERIORITY_OR_OTHER|||||||0.0102||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0102
71102169|NCT00561821|141712248|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71102170|NCT00561821|141712248|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71102171|NCT00561821|141712248|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71102172|NCT00561821|141712249|SUPERIORITY_OR_OTHER|||||||0.001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.001
71007005|NCT02442765|141522284|SUPERIORITY||Least Squares Mean Difference|-0.3|||=|0.4|TWO_SIDED|95.0|-1.1|0.5||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.5|-1.1|=0.400
71007006|NCT02442765|141522284|SUPERIORITY||Least Squares Mean Difference|-1.1|||=|0.115|TWO_SIDED|95.0|-2.4|0.3||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.3|-2.4|=0.115
71007007|NCT02442765|141522284|SUPERIORITY||Least Squares Mean Difference|-0.8|||=|0.264|TWO_SIDED|95.0|-2.1|0.6||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.6|-2.1|=0.264
71007008|NCT02442765|141522284|SUPERIORITY||MMRM weighted z-statistic|-2.44|||=|0.015|TWO_SIDED||||||ANCOVA|||||||=0.015
71007009|NCT02442765|141522284|SUPERIORITY||MMRM weighted z-statistic|-1.4|||=|0.163|TWO_SIDED||||||ANCOVA|||||||=0.163
71007010|NCT02442765|141522285|SUPERIORITY||Least Squares Mean Difference|-3.9|||=|0.05|TWO_SIDED|95.0|-7.8|0.0||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||-0.0|-7.8|=0.050
71007011|NCT02442765|141522285|SUPERIORITY||Least Squares Mean Difference|-1.6|||=|0.412|TWO_SIDED|95.0|-5.4|2.2||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||2.2|-5.4|=0.412
71007012|NCT02442765|141522285|SUPERIORITY||Least Squares Mean Difference|-1.0|||=|0.775|TWO_SIDED|95.0|-7.8|5.8||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||5.8|-7.8|=0.775
71007013|NCT02442765|141522285|SUPERIORITY||Least Squares Mean Difference|3.3|||=|0.333|TWO_SIDED|95.0|-3.5|10.1||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||10.1|-3.5|=0.333
71007014|NCT02442765|141522285|SUPERIORITY||MMRM weighted z-statistic|-1.5|||=|0.133|TWO_SIDED||||||ANCOVA|||||||=0.133
71007015|NCT02442765|141522285|SUPERIORITY||MMRM weighted z-statistic|0.22|||=|0.829|TWO_SIDED||||||ANCOVA|||||||=0.829
71007016|NCT02442765|141522286|SUPERIORITY||Least Squares Mean Difference|-0.2|||=|0.118|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|=0.118
71007017|NCT02442765|141522286|SUPERIORITY||Least Squares Mean Difference|-0.1|||=|0.191|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|=0.191
71007018|NCT02442765|141522286|SUPERIORITY||Least Squares Mean Difference|-0.2|||=|0.225|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|=0.225
71007019|NCT02442765|141522286|SUPERIORITY||Least Squares Mean Difference|-0.2|||=|0.227|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|=0.227
71007020|NCT02442765|141522286|SUPERIORITY||SPCD OLS weighted z-statistic|-1.97|||=|0.049|TWO_SIDED||||||ANCOVA|||||||=0.049
71007021|NCT02442765|141522286|SUPERIORITY||SPCD OLS weighted z-statistic|-1.78|||=|0.075|TWO_SIDED||||||ANCOVA|||||||=0.075
71007022|NCT02442765|141522287|SUPERIORITY||Least Squares Mean Difference|-0.1|||=|0.364|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|=0.364
71007023|NCT02442765|141522287|SUPERIORITY||Least Squares Mean Difference|-0.1|||=|0.427|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||||0.2|-0.4|=0.427
71007024|NCT02442765|141522287|SUPERIORITY||Least Squares Mean Difference|-0.4|||=|0.098|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||||0.1|-0.9|=0.098
71007025|NCT02442765|141522287|SUPERIORITY||Least Squares Mean Difference|-0.3|||=|0.168|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||||0.1|-0.8|=0.168
71007026|NCT02442765|141522287|SUPERIORITY||SPCD OLS weighted z-statistic|-1.86|||=|0.063|TWO_SIDED||||||ANCOVA|||||||=0.063
71007027|NCT02442765|141522287|SUPERIORITY||SPCD OLS weighted z-statistic|-1.57|||=|0.115|TWO_SIDED||||||ANCOVA|||||||=0.115
71007028|NCT02442765|141522288|SUPERIORITY||Least Squares Mean Difference|-0.4|||=|0.014|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|||||-0.1|-0.6|=0.014
71007029|NCT02442765|141522288|SUPERIORITY||Least Squares Mean Difference|-0.2|||=|0.111|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|=0.111
71007030|NCT02442765|141522288|SUPERIORITY||Least Squares Mean Difference|-0.5|||=|0.062|TWO_SIDED|95.0|-1.1|0.0|||ANCOVA|||||0.0|-1.1|=0.062
71007031|NCT02442765|141522288|SUPERIORITY||Least Squares Mean Difference|-0.3|||=|0.305|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||||0.3|-0.8|=0.305
71007032|NCT02442765|141522288|SUPERIORITY||SPCD OLS weighted z-statistic|-3.01|||=|0.003|TWO_SIDED||||||ANCOVA|||||||=0.003
71007033|NCT02442765|141522288|SUPERIORITY||SPCD OLS weighted z-statistic|-1.79|||=|0.073|TWO_SIDED||||||ANCOVA|||||||=0.073
71007034|NCT02442765|141522289|SUPERIORITY||Least Squares Mean Difference|0.1|||=|0.909|TWO_SIDED|95.0|-2.2|2.5|||ANCOVA|||||2.5|-2.2|=0.909
71007035|NCT02442765|141522289|SUPERIORITY||Least Squares Mean Difference|1.4|||=|0.226|TWO_SIDED|95.0|-0.9|3.8|||ANCOVA|||||3.8|-0.9|=0.226
71007036|NCT02442765|141522289|SUPERIORITY||Least Squares Mean Difference|2.1|||=|0.405|TWO_SIDED|95.0|-2.9|7.1|||ANCOVA|||||7.1|-2.9|=0.405
71007037|NCT02442765|141522289|SUPERIORITY||Least Squares Mean Difference|-0.9|||=|0.714|TWO_SIDED|95.0|-5.8|4.0|||ANCOVA|||||4.0|-5.8|=0.714
71007038|NCT02442765|141522289|SUPERIORITY||SPCD OLS weighted z-statistic|0.75|||=|0.456|TWO_SIDED||||||ANCOVA|||||||=0.456
71007039|NCT02442765|141522289|SUPERIORITY||SPCD OLS weighted z-statistic|0.42|||=|0.678|TWO_SIDED||||||ANCOVA|||||||=0.678
71007040|NCT02442765|141522290|SUPERIORITY||Least Squares Mean Difference|-0.4|||=|0.278|TWO_SIDED|95.0|-1.1|0.3|||ANCOVA|||||0.3|-1.1|=0.278
71007041|NCT02442765|141522290|SUPERIORITY||Least Squares Mean Difference|-0.1|||=|0.817|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|||||0.6|-0.8|=0.817
71007042|NCT02442765|141522290|SUPERIORITY||Least Squares Mean Difference|-0.4|||=|0.5|TWO_SIDED|95.0|-1.4|0.7|||ANCOVA|||||0.7|-1.4|=0.500
71007043|NCT02442765|141522290|SUPERIORITY||Least Squares Mean Difference|0.1|||=|0.795|TWO_SIDED|95.0|-0.9|1.2|||ANCOVA|||||1.2|-0.9|=0.795
71007044|NCT02442765|141522290|SUPERIORITY||SPCD OLS weighted z-statistic|-1.25|||=|0.213|TWO_SIDED||||||ANCOVA|||||||=0.213
71007045|NCT02442765|141522290|SUPERIORITY||SPCD OLS weighted z-statistic|0.02|||=|0.985|TWO_SIDED||||||ANCOVA|||||||=0.985
71045231|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|2.23||||0.0107|TWO_SIDED|95.0|1.21|4.14|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.14|1.21|0.0107
71045232|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|2.18||||0.0126|TWO_SIDED|95.0|1.18|4.02|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.02|1.18|0.0126
71045233|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|2.67||||0.1516|TWO_SIDED|95.0|0.7|10.26|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||10.26|0.70|0.1516
71045234|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|4.49||||0.021|TWO_SIDED|95.0|1.25|16.05|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||16.05|1.25|0.0210
71045235|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0034|TWO_SIDED|95.0|1.18|2.31|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.31|1.18|0.0034
71045236|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|1.75||||0.001|TWO_SIDED|95.0|1.26|2.45|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.45|1.26|0.0010
71045237|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|1.86||||0.0014|TWO_SIDED|95.0|1.27|2.71|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.71|1.27|0.0014
71007046|NCT02442765|141522292|SUPERIORITY||Least Squares Mean Difference|-1.6|||=|0.018|TWO_SIDED|95.0|-2.9|-0.3|||ANCOVA|||||-0.3|-2.9|=0.018
71007047|NCT02442765|141522292|SUPERIORITY||Least Squares Mean Difference|0.0|||=|0.956|TWO_SIDED|95.0|-1.3|1.3|||ANCOVA|||||1.3|-1.3|=0.956
71007048|NCT02442765|141522292|SUPERIORITY||Least Squares Mean Difference|1.1|||=|0.451|TWO_SIDED|95.0|-1.8|4.0|||ANCOVA|||||4.0|-1.8|=0.451
71007049|NCT02442765|141522292|SUPERIORITY||Least Squares Mean Difference|0.9|||=|0.519|TWO_SIDED|95.0|-1.9|3.7|||ANCOVA|||||3.7|-1.9|=0.519
71007050|NCT02442765|141522292|SUPERIORITY||SPCD OLS weighted z-statistic|-0.72|||=|0.471|TWO_SIDED||||||ANCOVA|||||||=0.471
71007051|NCT02442765|141522292|SUPERIORITY||SPCD OLS weighted z-statistic|0.5|||=|0.618|TWO_SIDED||||||ANCOVA|||||||=0.618
71007052|NCT01200758|141522299|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior Ctrough in SC formulation was demonstrated, if the lower bound of 90% confidence interval (CI) was above 0.8.|Geometric mean ratio|1.62|||||TWO_SIDED|90.0|1.36|1.94|||||Geometric mean ratio adjusted for tumor load at baseline.|||1.94|1.36|
71007053|NCT01200758|141522300|SUPERIORITY_OR_OTHER||Difference in response rates|-4.82||||0.2835|TWO_SIDED|95.0|-14.0|4.4|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||4.4|-14.0|0.2835
71007054|NCT01200758|141522300|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.38|1.33||||||||1.33|0.38|
71007055|NCT01200758|141522301|SUPERIORITY_OR_OTHER||Difference in response rates|7.66||||0.2047|TWO_SIDED|95.0|-5.0|20.3|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||20.3|-5.0|0.2047
71007056|NCT01200758|141522301|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.97|||||TWO_SIDED|95.0|0.68|5.71||||||||5.71|0.68|
71007057|NCT01200758|141522302|SUPERIORITY_OR_OTHER||Difference in response rates|-0.49||||0.8911|TWO_SIDED|95.0|-7.7|6.8|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson.|||6.8|-7.7|0.8911
71007058|NCT01200758|141522302|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.56|1.65||||||||1.65|0.56|
71045238|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|2.13|||<|0.0001|TWO_SIDED|95.0|1.46|3.1|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.10|1.46|<.0001
71007059|NCT01200758|141522303|SUPERIORITY_OR_OTHER||Difference in CRR|17.86||||0.0335|TWO_SIDED|95.0|0.8|35.0|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||35.0|0.8|0.0335
71007060|NCT01200758|141522303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.25|||||TWO_SIDED|95.0|1.06|4.78||||||||4.78|1.06|
71007061|NCT01200758|141522304|SUPERIORITY_OR_OTHER||Difference in response rates|-6.58||||0.2331|TWO_SIDED|95.0|-17.8|4.6|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||4.6|-17.8|0.2331
71007062|NCT01200758|141522304|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74|||||TWO_SIDED|95.0|0.44|1.22||||||||1.22|0.44|
71007063|NCT01200758|141522305|SUPERIORITY_OR_OTHER||Difference in response rates|0.49||||0.9157|TWO_SIDED|95.0|-8.8|9.8|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||9.8|-8.8|0.9157
71007064|NCT01200758|141522305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.66|1.51||||||||1.51|0.66|
71007065|NCT01200758|141522306|SUPERIORITY_OR_OTHER||Difference in response rates|-7.28||||0.1715|TWO_SIDED|95.0|-18.0|3.5|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||3.5|-18.0|0.1715
71007066|NCT01200758|141522306|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.52|1.22||||||||1.22|0.52|
71007067|NCT01200758|141522307|SUPERIORITY_OR_OTHER||Difference in response rates|-0.18||||0.9671|TWO_SIDED|95.0|-9.2|8.8|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||8.8|-9.2|0.9671
71007068|NCT01200758|141522307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.6|1.64||||||||1.64|0.60|
71007069|NCT01200758|141522309|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.5526|TWO_SIDED|95.0|0.64|1.26|||Wald test|||||1.26|0.64|0.5526
71007070|NCT01200758|141522311|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.9115|TWO_SIDED|95.0|0.71|1.36|||Wald test|||||1.36|0.71|0.9115
71007071|NCT01200758|141522314|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.38|||||TWO_SIDED|90.0|1.24|1.53||||||The ratio of observed rituximab serum was determined as AUC SC/AUC IV during Cycle 7 of induction treatment.||1.53|1.24|
71007072|NCT01200758|141522315|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.941|||||TWO_SIDED|95.0|0.872|1.015||||||||1.015|0.872|
71007073|NCT01795716|141522331|NON_INFERIORITY_OR_EQUIVALENCE|The 90%CIs of the test/reference ratios for AUC0-∞ and Cmax were determined. Log-transformed data were used in the analysis. Following international guidelines (including those of the SFDA), the test and reference for mutations were considered bioequivalent if the 90% CIs of the test/reference ratios of AUC was within range of 0.80 to 1.25 and Cmax was within 0.70 to 1.43.|||||<|0.05|TWO_SIDED||||||ANOVA|||The 90% confidence intervals of the test/reference ratios for AUC0-∞ and Cmax were determined. Log-transformed data were used in the analysis. Following international guidelines (including those of the SFDA), the test and reference for mutations were considered bioequivalent if the 90% CIs of the test/reference ratios of AUC was within range of 0.80 to 1.25 and Cmax was within 0.70 to 1.43.||||<0.05
71007074|NCT01369069|141522356|SUPERIORITY||Risk Ratio (RR)|0.97||||0.55|TWO_SIDED|95.0|0.87|1.08||The a priori threshold for statistical significance was 0.05.|Regression, Logistic||Adjusted for baseline NIHSS strata (3-7, 8-14, 15-22) and thrombolysis use (Yes/No; includes both IV and IA therapies). Multiple imputation was used for missing data.|It was hypothesized that intensive blood glucose control would be efficacious and safe in acute ischemic stroke patients compared to standard glucose control.||1.08|0.87|0.55
71007075|NCT01369069|141522357|SUPERIORITY||Risk Difference (RD)|2.58|||<|0.001|TWO_SIDED|95.0|1.29|3.87|||Fisher Exact||The data of the estimation parameter and the confidence intervals were presented as percentages.|||3.87|1.29|<0.001
71007076|NCT01369069|141522358|SUPERIORITY||Risk Difference (RD)|-1.07||||0.77|TWO_SIDED|95.0|-8.33|6.2|||Chi-squared||The data of the estimation parameter and the confidence intervals were presented as percentages.|||6.20|-8.33|0.77
71007077|NCT01369069|141522359|SUPERIORITY||Risk Difference (RD)|0.48||||0.88|TWO_SIDED|95.0|-5.79|6.75|||Chi-squared||The data of the estimation parameter and the confidence intervals were presented as percentages.|||6.75|-5.79|0.88
71007078|NCT01369069|141522360|SUPERIORITY||Median Difference (Final Values)|0.06||||0.74|TWO_SIDED|95.0|-0.13|0.25|||Wilcoxon (Mann-Whitney)|||||0.25|-0.13|0.74
71007079|NCT01369069|141522361|SUPERIORITY||Risk Ratio (RR)|0.82||||0.24|TWO_SIDED|95.0|0.58|1.15|||Chi-squared|||||1.15|0.58|0.24
71007080|NCT01809327|141522375|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.099||0.001|TWO_SIDED|95.0|-0.657|-0.269|||Mixed Model for Repeated Measures (MMRM)|||||-0.269|-0.657|0.001
71007081|NCT01809327|141522375|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.099||0.001|TWO_SIDED|95.0|-0.67|-0.28|||Mixed Model for Repeated Measures (MMRM)|||||-0.280|-0.670|0.001
71007082|NCT01809327|141522375|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.099||0.001|TWO_SIDED|95.0|-0.594|-0.207|||Mixed Model for Repeated Measures (MMRM)|||||-0.207|-0.594|0.001
71045239|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|2.61||||0.0007|TWO_SIDED|95.0|1.49|4.55|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.55|1.49|0.0007
71045240|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0018|TWO_SIDED|95.0|1.39|4.24|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.24|1.39|0.0018
71007083|NCT01809327|141522375|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.099||0.001|TWO_SIDED|95.0|-0.557|-0.169|||Mixed Model for Repeated Measures (MMRM)|||||-0.169|-0.557|0.001
71007084|NCT01809327|141522375|NON_INFERIORITY_OR_EQUIVALENCE|P value corresponds to a comparison that canagliflozin is noninferior to Metformin XR by a margin of 0.35%.|Least-Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.258|0.133|||Mixed Model for Repeated Measures (MMRM)|||||0.133|-0.258|0.001
70925428|NCT03232138|141344235|EQUIVALENCE|This analysis was focused on the gene set that were found to be downregulated in lung premalignant lesions. The objective was to examine if sulforaphane treatment for 12 months had any significant impact on the expression of these premalignant lesion-associated downregulated genes in nasal brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|-0.16|STANDARD_ERROR_OF_MEAN|0.14||0.27|TWO_SIDED|||||Hypothesis: Sulforaphane treatment would upregulate the expression of these genes whose downregulated expressions in bronchial epithelial cells have been found to be associated with risk of lung premalignant lesions.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after the 12-month sulforaphane treatment.|||||0.27
70925429|NCT03232138|141344236|EQUIVALENCE|Total number of adverse events by attrition and severity by treatment group during the study period, The Pittsburgh Clinical Trial of Sulforaphane (SFN) on Risk Markers of Lung Cancer||||||0.59||||||For severity by treatment group.|Fisher Exact|||||||0.590
70925430|NCT03232138|141344236|EQUIVALENCE|Total number of adverse events by attrition and severity by treatment group during the study period, The Pittsburgh Clinical Trial of Sulforaphane (SFN) on Risk Markers of Lung Cancer||||||0.131||||||For attribution by treatment group.|Fisher Exact|||||||0.131
70925431|NCT05516147|141344262|SUPERIORITY||||||<|0.01||||||A one-sample t-test was used to assess whether the mean was different from a known Constructive Engagement mean of 0.85 for standard programming.|t-test, 2 sided|||A one-sample t-test was used to assess whether the mean was different from a known Constructive Engagement mean of 0.85 for standard programming.||||<.01
70925432|NCT05516147|141344263|SUPERIORITY||||||<|0.01||||||A one-sample t-test was used to assess whether the mean was different from a known Passive Engagement mean of 1.06 for standard programming.|t-test, 2 sided|A one-sample t-test was used to assess whether the mean was different from a known Passive Engagement mean of 1.06 for standard programming.||A one-sample t-test was used to assess whether the mean was different from a known Passive Engagement mean of 1.06 for standard programming.||||<.01
70925433|NCT05516147|141344264|SUPERIORITY|||||||0.06||||||A one-sample t-test was used to assess whether the mean was different from a known Other Engagement mean of 0.42 for standard programming.|t-test, 2 sided|A one-sample t-test was used to assess whether the mean was different from a known Other Engagement mean of 0.42 for standard programming.||A one-sample t-test was used to assess whether the mean was different from a known Other Engagement mean of 0.42 for standard programming.||||0.06
70925434|NCT05516147|141344265|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||A one-sample t-test was used to assess whether the mean was different from a known Non Engagement mean of 0.40 for standard programming.||||<.01
70925435|NCT05516147|141344267|SUPERIORITY|||||||0.81|||||||t-test, 2 sided|||baseline score vs. post-treatment, paired sample t-test||||0.81
70925436|NCT05516147|141344268|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||baseline vs. post-treatment, paired sample t-test||||0.20
71102173|NCT00561821|141712249|SUPERIORITY_OR_OTHER|||||||0.0213||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0213
70925437|NCT05516147|141344269|SUPERIORITY|||||||0.83|||||||t-test, 2 sided|||baseline vs. post-treatment, paired sample t-test||||0.83
70925438|NCT05516147|141344270|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||baseline vs. post-treatment, paired sample t-test||||0.320
70925439|NCT00999804|141344284|SUPERIORITY_OR_OTHER_LEGACY||proportion of pCR|0.25|||||TWO_SIDED||||||||No comparison is required between the 24 weeks arm and 12 weeks arm. The study is designed as the 24 weeks arm ran as a single arm, using an admissible Simon-like two-stage design and required 20 or more responses in the first 55 evaluable patients.|"The study was planned to enroll 136 patients if the original cohort (n=90) was deemed successful. The 24 weeks arm ran as a single arm, using an admissible Simon-like two-stage design. The 12 weeks arm accrued as long as the 24 weeks arm is open.~The analysis of the first cohort indicated that 15 pCR were observed , which did not meet the required 20 or more responses. The accrual was closed early and the study has a total of 128 participants."||||
70925440|NCT00999804|141344285|SUPERIORITY_OR_OTHER_LEGACY||proportion of patients with AE|0.72|||||TWO_SIDED||||||||61 out of 85 patients (72%) in the 24-week arm had at least 1 adverse events.|This outcome is to establish the safety and tolerability of an extended regimen of lapatinib + trastuzumab, with or without endocrine therapy. No comparison between the 2 arms is required.||||
70925441|NCT00999804|141344286|SUPERIORITY_OR_OTHER_LEGACY||proportion of tpCR in 24 weeks arm|0.1|||||TWO_SIDED|||||||||No comparison between the two arms is required.||||
70925442|NCT00999804|141344287|SUPERIORITY_OR_OTHER_LEGACY||proportion of CR+PR in 24 weeks arm|0.69|||||TWO_SIDED|||||||||No comparison between the 2 arm is required for this study.||||
70925443|NCT04640298|141344288|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
70925444|NCT04640298|141344289|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
70925445|NCT04640298|141344290|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
70925446|NCT04166773|141344300|SUPERIORITY||Odds Ratio (OR)|7.45|||<|0.001|TWO_SIDED|95.0|2.27|24.44|||Regression, Logistic||Odds ratio, Confidence Interval (CI), and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||24.44|2.27|<0.001
70925447|NCT04166773|141344300|SUPERIORITY||Odds Ratio (OR)|11.86|||<|0.001|TWO_SIDED|95.0|3.59|39.11|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||39.11|3.59|<0.001
71102174|NCT00561821|141712249|SUPERIORITY_OR_OTHER|||||||0.0135||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0135
71102175|NCT00561821|141712250|SUPERIORITY_OR_OTHER|||||||0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0001
71102176|NCT00561821|141712250|SUPERIORITY_OR_OTHER|||||||0.0003||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0003
71007085|NCT01809327|141522375|NON_INFERIORITY_OR_EQUIVALENCE|P value corresponds to a comparison that canagliflozin is noninferior to Metformin XR by a margin of 0.35%.|Least-Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.099||0.001|TWO_SIDED|95.0|-0.307|0.082|||Mixed Model for Repeated Measures (MMRM)|||||0.082|-0.307|0.001
71007086|NCT01809327|141522376|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.4||0.016|TWO_SIDED|95.0|-1.6|-0.2|||Mixed Model for Repeated Measures (MMRM)|||||-0.2|-1.6|0.016
71007087|NCT01809327|141522376|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.4||0.002|TWO_SIDED|95.0|-2.6|-1.1|||Mixed Model for Repeated Measures (MMRM)|||||-1.1|-2.6|0.002
71007088|NCT01809327|141522376|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.4||0.001|TWO_SIDED|95.0|-2.1|-0.6|||Mixed Model for Repeated Measures (MMRM)|||||-0.6|-2.1|0.001
71007089|NCT01809327|141522376|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.4||0.001|TWO_SIDED|95.0|-2.9|-1.4|||Mixed Model for Repeated Measures (MMRM)|||||-1.4|-2.9|0.001
71007090|NCT01809327|141522377|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.027|TWO_SIDED|95.0|1.06|2.37|||Generalized Linear Mixed Model|||||2.37|1.06|0.027
71007091|NCT01809327|141522377|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21||||0.016|TWO_SIDED|95.0|1.46|3.33|||Generalized Linear Mixed Model|||||3.33|1.46|0.016
71007092|NCT01809327|141522378|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.91|STANDARD_ERROR_OF_MEAN|0.882||0.06|TWO_SIDED|95.0|-3.641|-0.182|||Mixed Model for Repeated Measures (MMRM)|||||-0.182|-3.641|0.060
71007093|NCT01809327|141522378|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.889||0.147|TWO_SIDED|95.0|-3.058|0.431|||Mixed Model for Repeated Measures (MMRM)|||||0.431|-3.058|0.147
71007094|NCT01809327|141522379|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|2.1||0.147|TWO_SIDED|95.0|1.2|9.5|||ANCOVA|||||9.5|1.2|0.147
71045241|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|4.1||||0.015|TWO_SIDED|95.0|1.31|12.79|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||12.79|1.31|0.0150
71007095|NCT01809327|141522379|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|4.3|STANDARD_ERROR_OF_MEAN|2.1||0.147|TWO_SIDED|95.0|0.2|8.5|||ANCOVA|||||8.5|0.2|0.147
71045242|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|3.79||||0.0211|TWO_SIDED|95.0|1.22|11.78|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||11.78|1.22|0.0211
71007096|NCT01809327|141522380|SUPERIORITY_OR_OTHER||Hodges-Lehman Estimate|-3.7||||0.608|TWO_SIDED|95.0|-11.1|3.4|||Wilcoxon (Mann-Whitney)|||||3.4|-11.1|0.608
71007097|NCT01809327|141522380|SUPERIORITY_OR_OTHER||Hodges-Lehman Estimate|1.3||||0.806|TWO_SIDED|95.0|-7.3|10.0|||Wilcoxon (Mann-Whitney)|||||10.0|-7.3|0.806
71007098|NCT04957745|141522387|OTHER||||||<|0.01||||||"Null hypothesis is that there is no difference in Percentage of Total Viewing Time that Peripheral Target is Perceived across visual confusion conditions."|ANOVA|||"Effect of visual confusion conditions (binocular, unilateral monocular, and bilateral monocular visual confusions) on Percentage of Total Viewing Time Peripheral Target is Perceived is analyzed by repeated measure (within-subject) ANOVA. The test was performed with a significance level of 0.05."||||<0.01
71007099|NCT00957723|141522427|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change from pre-op to 1 year, 2 year and 5 year||||<0.0001
71007100|NCT00957723|141522428|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change from pre-op to 1, 2, and 5 year||||<0.0001
71007101|NCT00957723|141522430|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||SF36 Physical Component Score change from preop to 1 year||||<0.0001
71007102|NCT00957723|141522430|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Sign test|||SF36 Mental Component Score change from preop to 1 year||||0.0002
71007103|NCT00957723|141522430|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||SF36 Physical Component Score change from preop to 2 years||||<0.0001
71007104|NCT00957723|141522430|SUPERIORITY_OR_OTHER|||||||0.0177|||||||Sign test|||SF36 Mental Component Score change from preop to 2 years||||0.0177
71007105|NCT00957723|141522430|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||SF36 Physical Component Score change from preop to 3 year||||<0.0001
71007106|NCT00957723|141522430|SUPERIORITY_OR_OTHER|||||||0.0393|||||||Sign test|||SF36 Mental Component Score change from preop to 3 year||||0.0393
71007107|NCT00957723|141522430|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||SF36 Physical Component Score change from preop to 4 year||||<0.0001
71007108|NCT00957723|141522430|SUPERIORITY_OR_OTHER|||||||0.4905|||||||t-test, 2 sided|||SF36 Mental Component Score change from preop to 4 year||||0.4905
71007109|NCT00957723|141522430|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||SF36 Physical Component Score change from preop to 5 year||||<0.0001
71007110|NCT00957723|141522430|SUPERIORITY_OR_OTHER|||||||0.0037|||||||Sign test|||SF36 Mental Component Score change from preop to 5 year||||0.0037
71007111|NCT00957723|141522432|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||LEAS score change from preop to 1, 2, 3, 4, and 5 years||||<0.0001
71007112|NCT00281528|141522436|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4476||95.0||||Group comparison was performed between group 260 mg/m\^2 ABI-007 every 3 weeks and group 130 mg/m\^2 ABI-007 weekly, as based on amended protocol, no type I error adjustment for multiplicity; a priori threshold for statistical significance is 0.05.|Cochran-Mantel-Haenszel|Stratified by study site||||||0.4476
70925448|NCT04166773|141344300|SUPERIORITY||Odds Ratio (OR)|19.63|||<|0.001|TWO_SIDED|95.0|5.73|67.25|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||67.25|5.73|<0.001
70925449|NCT04166773|141344301|SUPERIORITY||Odds Ratio (OR)|3.01||||0.025|TWO_SIDED|95.0|1.15|7.9|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||7.90|1.15|0.025
71007113|NCT04396106|141522449|OTHER|||||||0.721|||||||Cochran-Mantel-Haenszel|||||||0.721
71007114|NCT00537810|141522514|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|||||||Chi-squared|df=3||Post-treatment||||0.60
71007115|NCT00537810|141522514|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|||||||Chi-squared|df=3||6 month follow up||||0.13
71007116|NCT00537810|141522514|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Chi-squared|df=3||12 month follow up||||0.29
71007117|NCT01711359|141522560|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Noninferiority is concluded if the lower bound of the 95% CI for the difference in response rate is \>-12%|Newcombe-Wilson method|14.8|||||TWO_SIDED|95.0|5.5|24.1|||||Estimation Parameter: Newcombe-Wilson method without continuity correction for difference in the response rate (Baricitinib minus Methotrexate).|||24.1|5.5|
71007118|NCT02698176|141522582|OTHER||Estimation of DLT Rate|0.25|||||TWO_SIDED|80.0|0.121|0.418|||||Point estimate and 2-sided 80% Bayesian credible interval for DLT rate estimated for the total number of participants from all 3 cohorts (CRPC+NMC+TNBC) that were evaluable for DLT analysis based on a non-informative prior distribution of Beta (1,1).|||0.418|0.121|
71007119|NCT02253173|141522601|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007120|NCT02253173|141522601|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007121|NCT02253173|141522601|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007122|NCT02253173|141522602|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007123|NCT02253173|141522602|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007124|NCT02253173|141522602|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007125|NCT02253173|141522603|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007126|NCT02253173|141522603|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007127|NCT02253173|141522603|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007128|NCT02253173|141522604|SUPERIORITY_OR_OTHER|||||||0.0149|||||||Mixed Models Analysis|||||||0.0149
71007129|NCT02253173|141522604|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007130|NCT02253173|141522604|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71045243|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|2.01|||<|0.0001|TWO_SIDED|95.0|1.43|2.84|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.84|1.43|<.0001
71102177|NCT00561821|141712250|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
70925450|NCT04166773|141344301|SUPERIORITY||Odds Ratio (OR)|2.37||||0.074|TWO_SIDED|95.0|0.92|6.13|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors|||6.13|0.92|0.074
70925451|NCT04166773|141344301|SUPERIORITY||Odds Ratio (OR)|2.47||||0.063|TWO_SIDED|95.0|0.95|6.4|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||6.40|0.95|0.063
70925452|NCT04166773|141344302|SUPERIORITY||Odds Ratio (OR)|0.91||||0.893|TWO_SIDED|95.0|0.25|3.4|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||3.40|0.25|0.893
71007131|NCT02253173|141522605|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007132|NCT02253173|141522605|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007133|NCT02253173|141522605|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007134|NCT02253173|141522606|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007135|NCT02253173|141522606|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007136|NCT02253173|141522606|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007137|NCT02253173|141522607|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007138|NCT02253173|141522607|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007139|NCT02253173|141522607|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007140|NCT02253173|141522608|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007141|NCT02253173|141522608|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007142|NCT02253173|141522608|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007143|NCT02253173|141522609|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007144|NCT02253173|141522609|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007145|NCT02253173|141522609|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007146|NCT02253173|141522610|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007147|NCT02253173|141522610|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007148|NCT02253173|141522610|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007149|NCT02253173|141522611|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007150|NCT02253173|141522611|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007151|NCT02253173|141522611|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007152|NCT02253173|141522612|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71102178|NCT00561821|141712251|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71102179|NCT00561821|141712251|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71102180|NCT00561821|141712251|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71007153|NCT02253173|141522612|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007154|NCT02253173|141522612|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007155|NCT02253173|141522613|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007156|NCT02253173|141522613|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007157|NCT02253173|141522613|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007158|NCT02253173|141522614|SUPERIORITY_OR_OTHER|||||||0.026|||||||Mixed Models Analysis|||||||0.0260
71007159|NCT02253173|141522614|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Mixed Models Analysis|||||||0.0019
71007160|NCT02253173|141522614|SUPERIORITY_OR_OTHER|||||||0.0105|||||||Mixed Models Analysis|||||||0.0105
71007161|NCT02253173|141522615|SUPERIORITY_OR_OTHER|||||||0.0069|||||||Mixed Models Analysis|||||||0.0069
71007162|NCT02253173|141522615|SUPERIORITY_OR_OTHER|||||||0.0009|||||||Mixed Models Analysis|||||||0.0009
71007163|NCT02253173|141522615|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71102181|NCT00561821|141712252|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71007164|NCT02253173|141522616|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Mixed Models Analysis|||||||0.0003
71007165|NCT02253173|141522616|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007166|NCT02253173|141522616|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007167|NCT02253173|141522617|SUPERIORITY_OR_OTHER|||||||0.1269|||||||Mixed Models Analysis|||||||0.1269
71007168|NCT02253173|141522617|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Mixed Models Analysis|||||||0.0019
71007169|NCT02253173|141522617|SUPERIORITY_OR_OTHER|||||||0.0082|||||||Mixed Models Analysis|||||||0.0082
71007170|NCT02253173|141522618|SUPERIORITY_OR_OTHER|||||||0.0094|||||||Mixed Models Analysis|||||||0.0094
71007171|NCT02253173|141522618|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Mixed Models Analysis|||||||0.0001
71007172|NCT02253173|141522618|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Mixed Models Analysis|||||||0.0005
71007173|NCT02253173|141522619|SUPERIORITY_OR_OTHER|||||||0.0128|||||||Mixed Models Analysis|||||||0.0128
71007174|NCT02253173|141522619|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007175|NCT02253173|141522619|SUPERIORITY_OR_OTHER|||||||0.0008|||||||Mixed Models Analysis|||||||0.0008
71007176|NCT02253173|141522620|SUPERIORITY_OR_OTHER|||||||0.0014|||||||Mixed Models Analysis|||||||0.0014
71007177|NCT02253173|141522620|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007178|NCT02253173|141522620|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007179|NCT02253173|141522621|SUPERIORITY_OR_OTHER|||||||0.9616|||||||Mixed Models Analysis|||||||0.9616
71007180|NCT02253173|141522621|SUPERIORITY_OR_OTHER|||||||0.2439|||||||Mixed Models Analysis|||||||0.2439
71007181|NCT02253173|141522621|SUPERIORITY_OR_OTHER|||||||0.6518|||||||Mixed Models Analysis|||||||0.6518
71007182|NCT02253173|141522622|SUPERIORITY_OR_OTHER|||||||0.7829|||||||Mixed Models Analysis|||||||0.7829
71007183|NCT02253173|141522622|SUPERIORITY_OR_OTHER|||||||0.2328|||||||Mixed Models Analysis|||||||0.2328
71007184|NCT02253173|141522622|SUPERIORITY_OR_OTHER|||||||0.4118|||||||Mixed Models Analysis|||||||0.4118
71007185|NCT02253173|141522623|SUPERIORITY_OR_OTHER|||||||0.0639|||||||Mixed Models Analysis|||||||0.0639
71007186|NCT02253173|141522623|SUPERIORITY_OR_OTHER|||||||0.0356|||||||Mixed Models Analysis|||||||0.0356
71007187|NCT02253173|141522623|SUPERIORITY_OR_OTHER|||||||0.0914|||||||Mixed Models Analysis|||||||0.0914
71007188|NCT02253173|141522624|SUPERIORITY_OR_OTHER|||||||0.0503|||||||Mixed Models Analysis|||||||0.0503
71007189|NCT02253173|141522624|SUPERIORITY_OR_OTHER|||||||0.0055|||||||Mixed Models Analysis|||||||0.0055
71007190|NCT02253173|141522624|SUPERIORITY_OR_OTHER|||||||0.0263|||||||Mixed Models Analysis|||||||0.0263
71007191|NCT02253173|141522625|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007192|NCT02253173|141522625|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007193|NCT02253173|141522625|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007194|NCT02253173|141522626|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007195|NCT02253173|141522626|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007196|NCT02253173|141522626|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007197|NCT02253173|141522627|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007198|NCT02253173|141522627|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007199|NCT02253173|141522627|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007200|NCT02253173|141522628|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007201|NCT02253173|141522628|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007202|NCT02253173|141522628|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007203|NCT02253173|141522629|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71102182|NCT00561821|141712252|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71102183|NCT00561821|141712252|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71102184|NCT00561821|141712253|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71102185|NCT00561821|141712253|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71045244|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|2.19|||<|0.0001|TWO_SIDED|95.0|1.55|3.1|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.10|1.55|<.0001
71045245|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|2.1|||<|0.0001|TWO_SIDED|95.0|1.47|3.0|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.00|1.47|<.0001
71045246|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|2.08|||<|0.0001|TWO_SIDED|95.0|1.46|2.96|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.96|1.46|<.0001
71045247|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|1.74||||0.018|TWO_SIDED|95.0|1.1|2.76|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.76|1.10|0.0180
71045248|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|1.86||||0.0072|TWO_SIDED|95.0|1.18|2.94|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.94|1.18|0.0072
71045249|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|10.84||||0.0015|TWO_SIDED|95.0|2.49|47.22|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||47.22|2.49|0.0015
71045250|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|8.62||||0.0044|TWO_SIDED|95.0|1.96|37.96|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||37.96|1.96|0.0044
71045251|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0018|TWO_SIDED|95.0|1.22|2.43|||Regression, Logistic|||Week 16, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.43|1.22|0.0018
71102186|NCT00561821|141712253|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71102187|NCT00561821|141712254|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71102188|NCT00561821|141712254|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71007204|NCT02253173|141522629|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007205|NCT02253173|141522629|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007206|NCT02253173|141522630|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007207|NCT02253173|141522630|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007208|NCT02253173|141522630|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007209|NCT02253173|141522631|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007210|NCT02253173|141522631|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007211|NCT02253173|141522631|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007212|NCT02253173|141522632|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71102189|NCT00561821|141712254|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71007213|NCT02253173|141522632|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007214|NCT02253173|141522632|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007215|NCT02253173|141522633|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007216|NCT02253173|141522633|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007217|NCT02253173|141522633|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007218|NCT02253173|141522634|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007219|NCT02253173|141522634|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007220|NCT02253173|141522634|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007221|NCT02253173|141522635|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007222|NCT02253173|141522635|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007223|NCT02253173|141522635|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71102190|NCT00561821|141712255|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71007224|NCT02253173|141522636|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007225|NCT02253173|141522636|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007226|NCT02253173|141522636|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007227|NCT02253173|141522637|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Mixed Models Analysis|||||||0.0004
71007228|NCT02253173|141522637|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007229|NCT02253173|141522637|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007230|NCT02253173|141522638|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Mixed Models Analysis|||||||0.0001
71007231|NCT02253173|141522638|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007232|NCT02253173|141522638|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007233|NCT02253173|141522639|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007234|NCT02253173|141522639|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007235|NCT02253173|141522639|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007236|NCT02253173|141522640|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007237|NCT02253173|141522640|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007238|NCT02253173|141522640|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71007239|NCT02253173|141522641|SUPERIORITY_OR_OTHER|||||||0.9075|||||||ANCOVA|||||||0.9075
71007240|NCT02253173|141522641|SUPERIORITY_OR_OTHER|||||||0.0492|||||||ANCOVA|||||||0.0492
71007241|NCT02253173|141522641|SUPERIORITY_OR_OTHER|||||||0.0019|||||||ANCOVA|||||||0.0019
71007242|NCT02253173|141522642|SUPERIORITY_OR_OTHER|||||||0.9719|||||||ANCOVA|||||||0.9719
71007243|NCT02253173|141522642|SUPERIORITY_OR_OTHER|||||||0.0614|||||||ANCOVA|||||||0.0614
71007244|NCT02253173|141522642|SUPERIORITY_OR_OTHER|||||||0.0085|||||||ANCOVA|||||||0.0085
71007245|NCT02253173|141522643|SUPERIORITY_OR_OTHER|||||||0.9999|||||||ANCOVA|||||||0.9999
71007246|NCT02253173|141522643|SUPERIORITY_OR_OTHER|||||||0.2855|||||||ANCOVA|||||||0.2855
71007247|NCT02253173|141522643|SUPERIORITY_OR_OTHER|||||||0.1189|||||||ANCOVA|||||||0.1189
71007248|NCT02253173|141522644|SUPERIORITY_OR_OTHER|||||||0.4162|||||||ANCOVA|||||||0.4162
71007249|NCT02253173|141522644|SUPERIORITY_OR_OTHER|||||||0.0013|||||||ANCOVA|||||||0.0013
71007250|NCT02253173|141522644|SUPERIORITY_OR_OTHER|||||||0.0003|||||||ANCOVA|||||||0.0003
71007251|NCT02253173|141522645|SUPERIORITY_OR_OTHER|||||||0.9929|||||||ANCOVA|||||||0.9929
71102191|NCT00561821|141712255|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71102192|NCT00561821|141712255|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71102193|NCT00561821|141712256|SUPERIORITY_OR_OTHER|||||||0.6317||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.6317
71102194|NCT00561821|141712256|SUPERIORITY_OR_OTHER|||||||0.6355||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.6355
71102195|NCT00561821|141712256|SUPERIORITY_OR_OTHER|||||||0.7865||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.7865
71102196|NCT00561821|141712257|SUPERIORITY_OR_OTHER|||||||0.4033||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.4033
71102197|NCT00561821|141712257|SUPERIORITY_OR_OTHER|||||||0.4153||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.4153
70925453|NCT04166773|141344302|SUPERIORITY||Odds Ratio (OR)|0.73||||0.647|TWO_SIDED|95.0|0.18|2.87|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||2.87|0.18|0.647
70925454|NCT04166773|141344302|SUPERIORITY||Odds Ratio (OR)|0.39||||0.246|TWO_SIDED|95.0|0.08|1.91|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||1.91|0.08|0.246
71102198|NCT00561821|141712257|SUPERIORITY_OR_OTHER|||||||0.6271||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.6271
71102199|NCT00561821|141712258|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71007252|NCT02253173|141522645|SUPERIORITY_OR_OTHER|||||||0.9634|||||||ANCOVA|||||||0.9634
71007253|NCT02253173|141522645|SUPERIORITY_OR_OTHER|||||||0.0898|||||||ANCOVA|||||||0.0898
71007254|NCT02253173|141522646|SUPERIORITY_OR_OTHER|||||||0.5146|||||||ANCOVA|||||||0.5146
71102200|NCT00561821|141712258|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71102201|NCT00561821|141712258|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71102202|NCT00561821|141712259|SUPERIORITY_OR_OTHER|||||||0.0243||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0243
71102203|NCT00561821|141712259|SUPERIORITY_OR_OTHER|||||||0.0242||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0242
71007255|NCT02253173|141522646|SUPERIORITY_OR_OTHER|||||||0.0099|||||||ANCOVA|||||||0.0099
71007256|NCT02253173|141522646|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANCOVA|||||||0.0150
71102204|NCT00561821|141712259|SUPERIORITY_OR_OTHER|||||||0.0007||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0007
71102205|NCT00561821|141712260|SUPERIORITY_OR_OTHER|||||||0.0199||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0199
71102206|NCT00561821|141712260|SUPERIORITY_OR_OTHER|||||||0.0316||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0316
71102207|NCT00561821|141712260|SUPERIORITY_OR_OTHER|||||||0.0014||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0014
71102208|NCT03443401|141712286|SUPERIORITY||Mean Difference (Net)|80.0||||0.004|TWO_SIDED|||||level of significance at \<0.05|Spearman's rho|||||||0.004
71102209|NCT03443401|141712287|SUPERIORITY||Mean Difference (Net)|80.0||||0.027|TWO_SIDED|||||Level of significance \<0.05|Spearman's rho|||||||0.027
71102210|NCT00137449|141712288|SUPERIORITY_OR_OTHER||CBR Rate (percentage)|50.0||||||95.0|31.3|68.7|||F distribution|||||68.7|31.3|
71102211|NCT00137449|141712288|SUPERIORITY_OR_OTHER||CBR Rate (percentage)|56.7||||||95.0|37.4|74.5|||F distribution|||||74.5|37.4|
70925455|NCT04166773|141344303|SUPERIORITY||Odds Ratio (OR)|6.94|||<|0.001|TWO_SIDED|95.0|2.41|20.0|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||20.00|2.41|<0.001
70925456|NCT04166773|141344303|SUPERIORITY||Odds Ratio (OR)|10.46|||<|0.001|TWO_SIDED|95.0|3.36|32.61|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||32.61|3.36|<0.001
70925457|NCT04166773|141344303|SUPERIORITY||Odds Ratio (OR)|12.85|||<|0.001|TWO_SIDED|95.0|3.87|42.65|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||42.65|3.87|<0.001
71007257|NCT02253173|141522647|SUPERIORITY_OR_OTHER|||||||0.9039|||||||ANCOVA|||||||0.9039
71007258|NCT02253173|141522647|SUPERIORITY_OR_OTHER|||||||0.3751|||||||ANCOVA|||||||0.3751
71007259|NCT02253173|141522647|SUPERIORITY_OR_OTHER|||||||0.0073|||||||ANCOVA|||||||0.0073
71007260|NCT00498706|141522687|SUPERIORITY_OR_OTHER||t value|-2.95||||0.003||95.0|||||t-test, 2 sided|||||||0.003
71007261|NCT00498706|141522688|SUPERIORITY_OR_OTHER||Chi-square|5.83||||0.02||95.0|||||Chi-squared|||||||0.02
71102212|NCT00137449|141712288|SUPERIORITY_OR_OTHER||CBR Rate (percentage)|53.3||||||95.0|40.0|66.3|||F distribution|||Null hypothesis that the true CBR \<=20% vs the alternative hypothesis that the true clinical benefit rate is at least 35%. The sample size is determined using a single-stage design with an alpha level of 10% \& 90% power. If \>=17 CR, PR or SD for at least 24 weeks are observed, null hypothesis can be rejected with a 20% target false positive error rate. If \<= 16 CR, PR,or SD for at least 24 weeks are observed, null hypothesis can not be rejected with a target false negative error rate of 10%.||66.3|40.0|
70925458|NCT04166773|141344304|SUPERIORITY||LS Mean difference (Final Values)|-8.81|STANDARD_ERROR_OF_MEAN|1.632|<|0.001|TWO_SIDED|95.0|-12.04|-5.58|||Mixed Models Analysis|||||-5.58|-12.04|<0.001
70925459|NCT04166773|141344304|SUPERIORITY||LS Mean difference (Final Values)|-8.83|STANDARD_ERROR_OF_MEAN|1.566|<|0.001|TWO_SIDED|95.0|-11.93|-5.73|||Mixed Models Analysis|||||-5.73|-11.93|<0.001
70925460|NCT04166773|141344304|SUPERIORITY||LS Mean difference (Final Values)|-10.02|STANDARD_ERROR_OF_MEAN|1.591|<|0.001|TWO_SIDED|95.0|-13.17|-6.87|||Mixed Models Analysis|||||-6.87|-13.17|<0.001
70925461|NCT04166773|141344305|SUPERIORITY||LS Mean difference (Final Values)|-10.42|STANDARD_ERROR_OF_MEAN|1.976|<|0.001|TWO_SIDED|95.0|-14.32|-6.52|||Mixed Models Analysis|||||-6.52|-14.32|<0.001
70925462|NCT04166773|141344305|SUPERIORITY||LS Mean difference (Final Values)|-13.19|STANDARD_ERROR_OF_MEAN|1.96|<|0.001|TWO_SIDED|95.0|-17.05|-9.32|||Mixed Models Analysis|||||-9.32|-17.05|<0.001
70925463|NCT04166773|141344305|SUPERIORITY||LS Mean difference (Final Values)|-16.84|STANDARD_ERROR_OF_MEAN|1.957|<|0.001|TWO_SIDED|95.0|-20.71|-12.98|||Mixed Models Analysis|||||-12.98|-20.71|<0.001
71007262|NCT00498706|141522688|SUPERIORITY_OR_OTHER||Chi-square|7.75||||0.006||95.0|||||Chi-squared||Attrition before week 5 was significantly lower in T-CBT than in face-to-face CBT.|||||.006
71007263|NCT00498706|141522690|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority is established by showing that the true difference between 2 treatment arms is likely to be smaller than a prespecified noninferiority margin that separates clinically important from clinically negligible (acceptable) differences.|Mean Difference (Net)|-0.09|STANDARD_DEVIATION|1.26||0.89|TWO_SIDED|95.0|-1.35|1.17|||Mixed Models Analysis|||Longitudinal depression scores were modeled with repeated-measures linear regression models.Time was treated as a categorical variable to account for nonlinear effects of time, and an unstructured covariance matrix was assumed.||1.17|-1.35|0.89
71007264|NCT00498706|141522691|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority is established by showing that the true difference between 2 treatment arms is likely to be smaller than a prespecified noninferiority margin that separates clinically important from clinically negligible (acceptable) differences.|Mean Difference (Net)|1.07|STANDARD_DEVIATION|1.695||0.22|TWO_SIDED|95.0|-0.63|2.76|||Mixed Models Analysis|||Longitudinal depression scores were modeled with repeated-measures linear regression models.Time was treated as a categorical variable to account for nonlinear effects of time, and an unstructured covariance matrix was assumed.||2.76|-0.63|0.22
71007265|NCT00631969|141522713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.109|||<|0.0001||95.0|-8.562|-5.6561|||ANCOVA|||Power adjustment for 3 primary efficacy variables (3 variables have to be significant in favor of Vardenafil to conclude efficacy). Statistical analysis applies to the total population.||-5.6561|-8.562|< 0.0001
71007266|NCT00631969|141522714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.027|||<|0.0001||95.0|-35.519|-22.534|||ANCOVA|||Statistical analysis applies to the total population.||-22.534|-35.519|< 0.0001
71007267|NCT00631969|141522715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-38.193|||<|0.0001||95.0|-45.021|-31.366|||ANCOVA|||Statistical analysis applies to the total population.||-31.366|-45.021|< 0.0001
71007268|NCT00631969|141522716|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel|34.778|||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) adjusted for age group and pooled center.||Statistical analysis applies to the total population.||||<0.0001
71007269|NCT00631969|141522717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.503|||<|0.0001||95.0|-22.424|-10.764|||ANCOVA|||Statistical analysis applies to the total population.||-10.764|-22.424|< 0.0001
71102213|NCT00137449|141712290|SUPERIORITY_OR_OTHER||ORR rate (percentage)|10.0||||||95.0|2.1|26.5|||F distribution||PR or CR responding tumor measurements confirmed by repeat studies performed at \> 4 weeks after the criteria for response first met.|||26.5|2.1|
71102214|NCT00137449|141712290|SUPERIORITY_OR_OTHER||ORR rate (percentage)|16.7||||||95.0|5.6|34.7|||F distribution||PR or CR responding tumor measurements confirmed by repeat studies performed at \> 4 weeks after the criteria for response first met.|||34.7|5.6|
70925464|NCT05908344|141344306|OTHER|Effect size determination|Cohen's d|-0.24|||||TWO_SIDED|||||||||Comparison for NREM1 minutes. Group Selection refers to study device Condition (Active/Sham); repeated-measures design||||
70925465|NCT05908344|141344306|OTHER|Effect size determination|Cohen's d|-0.15|||||TWO_SIDED|||||||||Comparison for NREM2 minutes. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
70925466|NCT05908344|141344306|OTHER|Effect size determination|Cohen's d|0.69|||||TWO_SIDED|||||||||Comparison for NREM3 minutes. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
70925467|NCT05908344|141344306|OTHER|Effect size determination|Cohen's d|-0.82|||||TWO_SIDED|||||||||Comparison for REM minutes. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
70925468|NCT05908344|141344307|OTHER|Effect size determination|Cohen's d|-0.04|||||TWO_SIDED|||||||||Comparison for NREM1 percentage. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
70925469|NCT05908344|141344307|OTHER|Effect size determination|Cohen's d|0.24|||||TWO_SIDED|||||||||Comparison for NREM2 percentage. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
70925470|NCT05908344|141344307|OTHER|Effect size determination|Cohen's d|0.8|||||TWO_SIDED|||||||||Comparison for NREM3 percentage. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
70925471|NCT05908344|141344307|OTHER|Effect size determination|Cohen's d|-0.78|||||TWO_SIDED|||||||||Comparison for REM percentage. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
70925472|NCT05908344|141344308|OTHER|Effect size determination|Cohen's d|0.11|||||TWO_SIDED|||||||||Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
70925473|NCT05546749|141344322|SUPERIORITY||Mean Difference (Final Values)|-1.28|STANDARD_ERROR_OF_MEAN|0.93||0.17|TWO_SIDED|95.0|-3.1|0.54|||Mixed Models Analysis|||A mixed effects model was performed to predict pain intensity by arm at weeks 3 and 6, controlling for baseline pain intensity score.||0.54|-3.1|0.17
70925474|NCT05546749|141344323|SUPERIORITY||Mean Difference (Final Values)|-13.6|STANDARD_ERROR_OF_MEAN|13.6||0.32|TWO_SIDED|95.0|-40.3|13.1|||Mixed Models Analysis|||A mixed effects model was used to predict opioid craving score by arm at weeks 3 and 6, controlling for baseline opioid craving score.||13.1|-40.3|0.32
71007270|NCT00631969|141522718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-38.167|||<|0.0001||95.0|-45.261|-31.073|||ANCOVA|||Statistical analysis applies to the total population.||-31.073|-45.261|< 0.0001
71007271|NCT00631969|141522719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.555|||<|0.0001||95.0|-43.645|-29.465|||ANCOVA|||Statistical analysis applies to the total population.||-29.465|-43.645|< 0.0001
71007272|NCT00631969|141522720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.193|||<|0.0001||95.0|-31.562|-18.824|||ANCOVA|||Statistical analysis applies to the total population.||-18.824|-31.562|< 0.0001
71007273|NCT00631969|141522722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.703|||<|0.0001||95.0|-30.067|-19.34|||ANCOVA|||Statistical analysis applies to the total population.||-19.340|-30.067|< 0.0001
71007274|NCT00631969|141522723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.496|||<|0.0001||95.0|-34.865|-24.128|||ANCOVA|||Statistical analysis applies to the total population.||-24.128|-34.865|< 0.0001
71007275|NCT00631969|141522724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.775|||<|0.0001||95.0|-33.155|-22.394|||ANCOVA|||Statistical analysis applies to the total population.||-22.394|-33.155|< 0.0001
71007276|NCT00631969|141522725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.326|||<|0.0001||95.0|-29.062|-17.598|||ANCOVA|||Statistical analysis applies to the total population.||-17.598|-29.062|< 0.0001
71007277|NCT00631969|141522726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.384|||<|0.0001||95.0|-28.594|-18.175|||ANCOVA|||Statistical analysis applies to the total population.||-18.175|-28.594|< 0.0001
71007278|NCT00631969|141522727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.076|||<|0.0001||95.0|-38.745|-27.407|||ANCOVA|||Statistical analysis applies to the total population.||-27.407|-38.745|< 0.0001
71102215|NCT00137449|141712290|SUPERIORITY_OR_OTHER||ORR rate (percentage)|13.3||||||95.0|5.9|24.6|||F distribution||PR or CR responding tumor measurements confirmed by repeat studies performed at \> 4 weeks after the criteria for response first met.|||24.6|5.9|
71102216|NCT00137449|141712292|SUPERIORITY_OR_OTHER||median|27.0||||||95.0|22.0|73.1|||Kaplan-Meier method|||95% CI calculated based on the method of Brookmeyer and Crowley. Median reported is progression free survival weeks.||73.1|22.0|
71102217|NCT00137449|141712292|SUPERIORITY_OR_OTHER||median|35.1||||||95.0|24.4|51.6|||Kaplan-Meier method|||95% CI calculated based on the method of Brookmeyer and Crowley.Median reported is progression free survival weeks.||51.6|24.4|
71102218|NCT00137449|141712292|SUPERIORITY_OR_OTHER||median|33.6||||||95.0|24.1|49.0|||Kaplan-Meier method|||95% CI calculated based on the method of Brookmeyer and Crowley.Median reported is progression free survival weeks.||49.0|24.1|
71007279|NCT00631969|141522728|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel|74.449|||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) adjusted for pooled centers and age group.||Statistical analysis applies to the total population.||||<0.0001
71007280|NCT00631969|141522729|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of Vardenafil exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.|Point estimate of ratio|117.42||||||90.0|79.59|173.23||||||Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years / patients aged \< 65 years) were calculated.||173.23|79.59|
71007281|NCT00631969|141522729|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of Vardenafil exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.||||||0.7064||95.0|||||Regression, Linear|||A linear regression line is fitted to the logarithm of AUC. Test of the hypothesis of a zero slope using the two-sided t-test at α = 0.05.||||0.7064
71007282|NCT00631969|141522730|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of Vardenafil exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.|Point estimate of ratio|133.07||||||90.0|87.46|202.46||||||Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years / patients aged \< 65 years) were calculated.||202.46|87.46|
71007283|NCT00631969|141522730|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of Vardenafil exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.||||||0.8749||95.0|||||Regression, Linear|||A linear regression line is fitted to the logarithm of Cmax. Test of the hypothesis of a zero slope using the two-sided t-test at α=0.05.||||0.8749
71102219|NCT00137449|141712293|SUPERIORITY_OR_OTHER||median|57.0||||||95.0|24.1|73.1|||Kaplan-Meier method|||95% CI calculated based on the method of Brookmeyer and Crowley.Time to progression in weeks reported as median.||73.1|24.1|
71102220|NCT00137449|141712293|SUPERIORITY_OR_OTHER||median|42.1||||||95.0|26.1|65.9|||Kaplan-Meier method|||95% CI calculated based on the method of Brookmeyer and Crowley.Time to progression in weeks reported as median.||65.9|26.1|
71102221|NCT00137449|141712293|SUPERIORITY_OR_OTHER||median|42.1||||||95.0|26.1|65.9|||Kaplan-Meier method|||95% CI calculated based on the method of Brookmeyer and Crowley.Time to progression in weeks reported as median.||65.9|26.1|
71102222|NCT00137449|141712295|SUPERIORITY_OR_OTHER||1 year survival rate|60.0||||||95.0|40.5|75.0|||Kaplan-Meier method|||||75.0|40.5|
71007284|NCT00631969|141522731|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of metabolite M-1 exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.|Point estimate of ratio|125.28||||||90.0|73.65|213.11||||||Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years/ patients aged \< 65 years) were calculated.||213.11|73.65|
71007285|NCT00631969|141522731|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of metabolite M-1 exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.||||||0.7375||95.0|||||Regression, Linear|||A linear regression line is fitted to the logarithm of AUC. Test of the hypothesis of a zero slope using the two-sided t-test at α=0.05.||||0.7375
71007286|NCT00631969|141522732|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of metabolite M-1 exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.|Point estimate of ratio|123.84||||||90.0|80.12|191.42||||||Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years / patients aged \< 65 years) were calculated.||191.42|80.12|
71007287|NCT00631969|141522732|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of metabolite M-1 exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.||||||0.394||95.0|||||Regression, Linear|||A linear regression line is fitted to the logarithm of Cmax. Test of the hypothesis of a zero slope using the two-sided t-test at α = 0.05.||||0.3940
71007288|NCT02043704|141522766|EQUIVALENCE|The null hypothesis is that there is no difference in the pain scores between the groups.||||||0.328||||||The p-value was not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|There were no adjustments.||The comparison was analyzed using the Mann-Whitney U test.||||0.328
71007289|NCT03474380|141522802|SUPERIORITY|A generalized linear mixed model (GLMM) with a negative binomial distribution and a log link was fit including a time-varying indicator for when iHI-FIVES program launched, fixed effects for time (indicator variables for each of the time periods) and site. The final model was adjusted for Veteran characteristics, including age, gender, race, marital status, service connection, rural status, and chronic disease burden concurrence score (Nosos).|rate ratio (RR)|0.58||||0.091|TWO_SIDED|95.0|0.31|1.09|||generalized linear mixed model (GLMM)||Rate ratio, rate of days not in the community in 6 month intervals in intervention versus usual care.|Days not at home in 6 month intervals.||1.09|0.31|0.091
71007290|NCT03474380|141522803|SUPERIORITY|A generalized linear mixed model (GLMM) was fit including a time-varying indicator for when iHI-FIVES program launched, fixed effects for time (indicator variables for each of the time periods), site, and indicator for the time point of the survey, and an indicator for the interaction of the time point of the survey with the time-varying indicator for treatment. The final model was adjusted for caregiver characteristics.|Mean Difference (Net)|0.0||||0.98|TWO_SIDED|95.0|-0.7|0.8|||Mixed Models Analysis||This is the estimated mean difference from baseline to 3 months between usual care and intervention.|||0.8|-0.7|0.98
71007291|NCT03474380|141522804|SUPERIORITY|A generalized linear mixed model (GLMM) was fit including a time-varying indicator for when iHI-FIVES program launched, fixed effects for time (indicator variables for each of the time periods), site, and indicator for the time point of the survey, and an indicator for the interaction of the time point of the survey with the time-varying indicator for treatment. The final model was adjusted for caregiver characteristics.|Mean Difference (Net)|0.4||||0.167|TWO_SIDED|95.0|-0.2|1.0|||Mixed Models Analysis||This is the estimated mean difference from baseline to 3 months between usual care and intervention.|||1.0|-0.2|0.167
71007292|NCT03474380|141522805|SUPERIORITY|A generalized linear mixed model (GLMM) was fit including a time-varying indicator for when iHI-FIVES program launched, fixed effects for time (indicator variables for each of the time periods), site, and indicator for the time point of the survey, and an indicator for the interaction of the time point of the survey with the time-varying indicator for treatment. The final model was adjusted for caregiver characteristics.|Mean Difference (Net)|-0.5||||0.122|TWO_SIDED|95.0|-1.0|0.1|||Mixed Models Analysis||This is the estimated mean difference from baseline to 3 months between usual care and intervention.|||0.1|-1.0|0.122
71007293|NCT00626327|141522806|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM+MMRV group was considered non-inferior to that of MMRV group if the lower limit of the two-sided 95% CI of the difference in the percentage of subjects with seroconversion for measles was greater than -5%, at 6 weeks after MMRV vaccination.|Difference % (MenACWY-CRM+MMRV-MMRV)|-1.0|||||TWO_SIDED|95.0|-3.4|0.5||||||Non-inferiority of immune response to measles following one dose of MMRV administered concomitantly with MenACWY-CRM as compared to MMRV given alone.||0.5|-3.4|
71007294|NCT00626327|141522806|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM+MMRV group was considered non-inferior to that of MMRV group if the lower limit of the two-sided 95% CI of the difference in the percentage of subjects with seroconversion for mumps was greater than -5%, at 6 weeks after MMRV vaccination.|Difference % (MenACWY-CRM+MMRV - MMRV )|1.0|||||TWO_SIDED|95.0|-1.0|3.7||||||Non-inferiority of immune response to mumps following one dose of MMRV administered concomitantly with MenACWY-CRM as compared to MMRV administered alone.||3.7|-1|
71007295|NCT00626327|141522806|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM+MMRV group was considered non-inferior to that of MMRV group if the lower limit of the two-sided 95% CI of the difference in the percentage of subjects with seroconversion for rubella was greater than -5%, at 6 weeks after MMRV vaccination.|Difference% (MenACWY-CRM+MMRV-MMRV)|-2.0|||||TWO_SIDED|95.0|-4.5|0.8||||||Non-inferiority of immune response to rubella following one dose of MMRV administered concomitantly with MenACWY-CRM as compared to MMRV administered alone.||0.8|-4.5|
71007296|NCT00626327|141522806|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM+MMRV group was considered non-inferior to that of MMRV group if the lower limit of the two-sided 95% CI of the difference in the percentage of subjects with seroprotection for varicella was greater than -10%, at 6 weeks after MMRV vaccination.|Difference% (MenACWY-CRM+MMRV-MMRV)|-1.0|||||TWO_SIDED|95.0|-3.9|1.2||||||Non-inferiority of immune response to varicella following one dose of MMRV administered concomitantly with MenACWY-CRM as compared to MMRV administered alone.||1.2|-3.9|
71007297|NCT00626327|141522807|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM + MMRV group was considered non-inferior to that of MenACWY-CRM group if the lower limit of the two-sided 95% CI around the difference of the percentage of subjects with hSBA ≥1:8 at 6 weeks after the second dose of MenACWY-CRM given to 12 month old toddlers was greater than -10% for each serogroup.|Difference% (MenACWY-CRM+MMRV-MenACWY)|0.0|||||TWO_SIDED|95.0|-4.7|4.5||||||Non-inferiority of immune response of MenACWY-CRM against serogroup A when concomitantly administered with MMRV vaccine as compared to MenACWY-CRM vaccine given alone.||4.5|-4.7|
70925475|NCT05546749|141344332|SUPERIORITY||Mean Difference (Final Values)|-9.7|STANDARD_ERROR_OF_MEAN|6.1||0.137|TWO_SIDED|95.0|-23.1|3.6|||Regression, Linear||RelieVRx was associated with lower stress score.|We performed a mixed effects model to predict stress score at week 6 by arm, controlling for baseline stress score.||3.6|-23.1|0.137
70925476|NCT05026320|141344508|EQUIVALENCE|The primary efficacy hypothesis to be tested was the equality of tenderness (algometry) over the initial 72 hours (algometry AUC 0-72).||||||0.0221|||||||ANCOVA|||||||0.0221
71007298|NCT00626327|141522807|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM + MMRV group was considered non-inferior to that of MenACWY-CRM group if the lower limit of the two-sided 95% CI around the difference of the percentage of subjects with hSBA ≥1:8 at 6 weeks after the second dose of MenACWY-CRM given to 12 month old toddlers was greater than -10% for each serogroup.|Difference% (MenACWY-CRM+MMRV-MenACWY)|0.0|||||TWO_SIDED|95.0|-1.8|1.9||||||Non-inferiority of immune response of MenACWY-CRM against serogroup C when concomitantly administered with MMRV vaccine as compared to MenACWY-CRM vaccine given alone.||1.9|-1.8|
71007299|NCT00626327|141522807|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM + MMRV group was considered non-inferior to that of MenACWY-CRM group if the lower limit of the two-sided 95% CI around the difference of the percentage of subjects with hSBA ≥1:8 at 6 weeks after the second dose of MenACWY-CRM given to 12 month old toddlers was greater than -10% for each serogroup.|Difference% (MenACWY-CRM+MMRV-MenACWY)|1.0|||||TWO_SIDED|95.0|-1.3|3.9||||||Non-inferiority of immune response of MenACWY-CRM against serogroup W-135 when concomitantly administered with MMRV vaccine as compared to MenACWY vaccine given alone.||3.9|-1.3|
71007300|NCT00626327|141522807|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM + MMRV group was considered non-inferior to that of MenACWY-CRM group if the lower limit of the two-sided 95% CI around the difference of the percentage of subjects with hSBA ≥1:8 at 6 weeks after the second dose of MenACWY-CRM given to 12 month old toddlers was greater than -10% for each serogroup.|Difference% (MenACWY-CRM+MMRV-MenACWY)|2.0|||||TWO_SIDED|95.0|-1.9|5.3||||||Non-inferiority of immune response of MenACWY-CRM against serogroup Y when concomitantly administered with MMRV vaccine as compared to MenACWY-CRM vaccine given alone.||5.3|-1.9|
71007301|NCT00626327|141522812|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MMRV+MenACWY group was considered non-inferior to that of MMRV group if the lower limit of the two-sided 95% CI of the difference in the percentages of subjects with seroconversion for varicella was greater than -10%.|Difference% (MenACWY-CRM+MMRV- MMRV)|-1.0|||||TWO_SIDED|95.0|-2.4|0.8||||||Non-inferiority of anti-varicella response following one dose of MMRV when administered concomitantly with MenACWY vaccine as compared to MMRV administered alone.||0.8|-2.4|
71007302|NCT01143116|141522818|OTHER|||||||0.625|||||||Wilcoxon (Mann-Whitney)|||||||0.6250
71007303|NCT01143116|141522818|OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.7500
71007304|NCT01143116|141522819|OTHER|||||||0.875|||||||Wilcoxon (Mann-Whitney)|||||||0.8750
71007305|NCT01143116|141522819|OTHER|||||||0.625|||||||Wilcoxon (Mann-Whitney)|||||||0.6250
71007306|NCT01143116|141522820|OTHER|||||||0.0254|||||||Wilcoxon (Mann-Whitney)|||||||0.0254
71007307|NCT01143116|141522820|OTHER|||||||0.0039|||||||Wilcoxon (Mann-Whitney)|||||||0.0039
71007308|NCT01143116|141522821|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
71007309|NCT01143116|141522821|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0000
71007310|NCT01143116|141522822|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
71007311|NCT01143116|141522822|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0000
71007312|NCT01143116|141522823|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0000
71007313|NCT01143116|141522824|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0000
71007314|NCT01143116|141522825|OTHER|||||||0.0313|||||||Wilcoxon (Mann-Whitney)|||||||0.0313
71007315|NCT01143116|141522825|OTHER|||||||0.0078|||||||Wilcoxon (Mann-Whitney)|||||||0.0078
71007316|NCT01143116|141522826|OTHER|||||||0.7188|||||||Wilcoxon (Mann-Whitney)|||||||0.7188
71007317|NCT01143116|141522826|OTHER|||||||0.6406|||||||Wilcoxon (Mann-Whitney)|||||||0.6406
71007318|NCT01143116|141522827|OTHER|||||||0.4375|||||||Wilcoxon (Mann-Whitney)|||||||0.4375
71007319|NCT01143116|141522827|OTHER|||||||0.2969|||||||Wilcoxon (Mann-Whitney)|||||||0.2969
71007320|NCT01143116|141522828|OTHER|||||||0.5391|||||||Wilcoxon (Mann-Whitney)|||||||0.5391
71007321|NCT01143116|141522828|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.0010
71007322|NCT01143116|141522829|OTHER|||||||0.4766|||||||Wilcoxon (Mann-Whitney)|||||||0.4766
70925477|NCT05478499|141344511|SUPERIORITY||Odds Ratio (OR)|6.2|||<|0.0001|TWO_SIDED|95.0|2.5|15.3|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel|Full Analysis Set||15.3|2.5|<0.0001
70925478|NCT05478499|141344511|SUPERIORITY||Odds Ratio (OR)|7.0|||<|0.0001|TWO_SIDED|95.0|2.7|18.4|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel|Patient sub-population (s-PGA ≥ 3)||18.4|2.7|<0.0001
70925479|NCT05478499|141344512|SUPERIORITY||Odds Ratio (OR)|40.2|||<|0.0001||95.0|4.6|352.0|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel|Full Analysis Set||352.0|4.6|<0.0001
70925480|NCT05478499|141344512|SUPERIORITY||Odds Ratio (OR)|37.3|||<|0.0001|TWO_SIDED|95.0|4.4|317.6|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel|Patient sub-population (s-PGA ≥ 3)||317.6|4.4|<0.0001
71007323|NCT01143116|141522829|OTHER|||||||0.0068|||||||Wilcoxon (Mann-Whitney)|||||||0.0068
71007324|NCT01143116|141522830|OTHER|||||||0.0625|||||||Wilcoxon (Mann-Whitney)|||||||0.0625
71007325|NCT01143116|141522830|OTHER|||||||0.418|||||||Wilcoxon (Mann-Whitney)|||||||0.4180
71007326|NCT01797302|141522837|SUPERIORITY|||||||0.88||||||interaction term from model group\*time|Mixed Models Analysis|||||||0.88
71007327|NCT01797302|141522838|SUPERIORITY|||||||0.85||||||interaction term for group\*time|Mixed Models Analysis|||||||0.85
71007328|NCT01797302|141522839|SUPERIORITY|||||||0.61||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.61
71007329|NCT01797302|141522840|SUPERIORITY|||||||0.24||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.24
71007330|NCT01797302|141522841|SUPERIORITY|||||||0.0117||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.0117
71007331|NCT01797302|141522842|SUPERIORITY|||||||0.53||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.53
71007332|NCT01797302|141522843|SUPERIORITY|||||||0.0256||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.0256
71007333|NCT01797302|141522844|SUPERIORITY|||||||0.0945||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.0945
70925481|NCT05478499|141344513|SUPERIORITY||Adjusted mean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001||95.0|-3.3|-1.6|||analysis of covariance model||analysis of covariance model|Full Analysis Set||-1.6|-3.3|<0.0001
70925482|NCT05478499|141344513|SUPERIORITY||Adjusted mean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|-3.3|-1.5|||analysis of covariance model||analysis of covariance model|Patient sub-population (s-PGA ≥ 3)||-1.5|-3.3|<0.0001
71007334|NCT01797302|141522845|SUPERIORITY|||||||0.12||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.12
71102223|NCT00137449|141712295|SUPERIORITY_OR_OTHER||1 year survival rate|79.7||||||95.0|60.3|90.3|||Kaplan-Meier method|||||90.3|60.3|
71102224|NCT00137449|141712295|SUPERIORITY_OR_OTHER||1 year survival rate|69.7||||||95.0|56.3|79.7|||Kaplan-Meier method|||||79.7|56.3|
71102225|NCT01356940|141712299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.586||||0.586|TWO_SIDED||||||Mixed Models Analysis||P values above 0.05 are considered statistically not significant in this study|||||0.586
71102226|NCT00124657|141712329|SUPERIORITY_OR_OTHER||Kaplan-Meier|0.75|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.48|1.0||||||1-year progression-free survival (n=8)||1.00|0.48|
71102227|NCT00124657|141712329|SUPERIORITY_OR_OTHER||Kaplan-Meier|0.33|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|0.09|0.57||||||1-year progression-free survival (n=12)||0.57|0.09|
71102228|NCT00124657|141712329|SUPERIORITY_OR_OTHER||Kaplan-Meier|0.45|STANDARD_DEVIATION|0.106|||TWO_SIDED|95.0|0.198|0.602||||||1-year progression free survival (n=20)||0.602|0.198|
71007335|NCT01797302|141522846|SUPERIORITY|||||||0.0094||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.0094
71007336|NCT00848172|141522863|SUPERIORITY_OR_OTHER||||||=|0.345||95.0|||||Mixed Models Analysis|||||||=0.345
71007337|NCT00848172|141522864|SUPERIORITY_OR_OTHER||||||=|0.031||95.0|||||Mixed Models Analysis|||||||=0.031
71007338|NCT02176226|141522867|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
70925483|NCT05478499|141344514|SUPERIORITY||Odds Ratio (OR)|23.9|||<|0.0001|TWO_SIDED|95.0|5.4|105.6|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel|||105.6|5.4|<0.0001
71007339|NCT02176226|141522868|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
71007340|NCT03894501|141522885|SUPERIORITY|||||||0.048|||||||ANOVA|||||||.048
71007341|NCT03894501|141522886|SUPERIORITY|||||||0.037|||||||ANCOVA|||||||.037
71007342|NCT03894501|141522887|SUPERIORITY|||||||0.024|||||||ANCOVA|||||||.024
71007343|NCT03894501|141522888|SUPERIORITY|||||||0.005|||||||ANCOVA|||||||.005
70925484|NCT02962895|141344520|SUPERIORITY||Least Squares Mean Difference|0.75||||0.5161|TWO_SIDED|95.0|-1.52|3.02|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo||3.02|-1.52|0.5161
70925485|NCT02962895|141344520|SUPERIORITY||Least Squares Mean Difference|-0.55||||0.6332|TWO_SIDED|95.0|-2.8|1.71|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo||1.71|-2.80|0.6332
71007344|NCT03894501|141522889|SUPERIORITY|||||||0.013|||||||ANOVA|||||||.013
71007345|NCT03894501|141522890|SUPERIORITY|||||||0.035|||||||ANOVA|||||||.035
71007346|NCT00779116|141522935|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Statistical tests were performed atthe significance level of 5%, without multiplicity adjustment.|Mainland-Gart Test|The p-value was derived from Mainland-Gart Test applied to a 2 (treatment sequence) by 2 (preferred period) contingency table.||The Mainland-Gart test was applied to the preference rates in the subjects who showed a preference, to assess the difference in preference rates between RediTab and Zyrtec.||||<0.0001
71007347|NCT00266799|141522947|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority was tested using the upper limit of the 95% CI for the hazard ratio as quantitative estimate of the minimum effect of PLD relative to capecitabine. Margin for non-inferiority was set to 1.143, reflecting an acceptable difference in TTP of 0.75 months assuming an expected median TTP of up to 6 months with the comparator. If the estimate was below margin, PLD was to be considered non-inferior to capecitabine assuming sufficient sensitivity to detect the drug effects of~interest."|Hazard Ratio (HR)|1.08||||0.6686|TWO_SIDED|95.0|0.76|1.54|||Log Rank|||By Investigator Assessment of ITT Population||1.54|0.76|0.6686
71102229|NCT00124657|141712329|SUPERIORITY_OR_OTHER||Kaplan-Meier|0.15|STANDARD_DEVIATION|0.069|||TWO_SIDED|95.0|0.015|0.285||||||2-year progression free survival (n=20)||0.285|0.015|
71102230|NCT00124657|141712329|SUPERIORITY_OR_OTHER||Kaplan-Meier|0.19|STANDARD_DEVIATION|0.077|||TWO_SIDED|95.0|0.039|0.341||||||1-year progression free survival (n=21)||0.341|0.039|
71102231|NCT00124657|141712329|SUPERIORITY_OR_OTHER||Kaplan-Meier|0.19|STANDARD_DEVIATION|0.077|||TWO_SIDED|95.0|0.039|0.341||||||2-year progression free survival (n=21)||0.341|0.039|
71102232|NCT04507763|141712341|OTHER|||||||0.001|||||||Regression, Logistic|||Change from Baseline at Month 12: For Early Referral||||0.001
71102233|NCT04507763|141712342|OTHER|||||||0.001|||||||Regression, Logistic|||Change from Baseline at Month 12: For Early Referral||||0.001
71102234|NCT02655601|141712396|SUPERIORITY||Hazard Ratio (HR)|0.791||||0.135|ONE_SIDED|95.0||95.0||Study was originally designed with 1 IA after approximately 42 deaths. An unplanned, 2nd IA was conducted to support a BTDR. The study was not terminated early as a result of either IAs. No further IA were conducted until the primary analysis.|Log Rank|89 study participants had passed away at the time of this analysis (41 in the RT/TMZ + BMX-001 arm and 48 in the Radiation Therapy/TMZ arm).||A 1-tailed logrank test was conducted at the 0.2 level. This test had 90% power to detect a hazard ratio of 0.63 after 84 deaths were observed among the 160 randomized patients.||95||0.135
71007348|NCT00266799|141522947|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority was tested using the upper limit of the 95% CI for the hazard ratio as quantitative estimate of the minimum effect of PLD relative to capecitabine. Margin for non-inferiority was set to 1.143, reflecting an acceptable difference in TTP of 0.75 months assuming an expected median TTP of up to 6 months with the comparator. If the estimate was below margin, PLD was to be considered non-inferior to capecitabine assuming sufficient sensitivity to detect the drug effects of~interest."|Hazard Ratio (HR)|1.15||||0.4472|TWO_SIDED|95.0|0.8|1.65|||Log Rank|||By RECIST Criteria of ITT Population||1.65|0.80|0.4472
71007349|NCT00266799|141522947|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.5508|TWO_SIDED|95.0|0.74|1.77|||Log Rank|||By Investigator Assessment of TTP Population||1.77|0.74|0.5508
71007350|NCT00266799|141522947|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||0.4088|TWO_SIDED|95.0|0.77|1.89|||Log Rank|||By RECIST Criteria of TTP Population||1.89|0.77|0.4088
71007351|NCT00266799|141522948|SUPERIORITY_OR_OTHER|||||||0.1726||95.0|||||Chi-squared|||By Investigator Assessment||||0.1726
71007352|NCT00266799|141522948|SUPERIORITY_OR_OTHER|||||||0.6541||95.0|||||Chi-squared|||By RECIST Criteria||||0.6541
71007353|NCT00266799|141522949|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12||||0.5265|TWO_SIDED|95.0|0.79|1.58|||Log Rank|||||1.58|0.79|0.5265
71007354|NCT00266799|141522950|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.0841||95.0|||||Log Rank|p-value also given for Hazard Ratio||||||0.0841
71007355|NCT00242710|141522956|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|2.37|||<|0.001|TWO_SIDED|95.0|1.56|3.18|||ANCOVA|||An analysis of covariance (ANCOVA) model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||3.18|1.56|<0.001
71007356|NCT00242710|141522956|SUPERIORITY_OR_OTHER||LS Mean Difference|2.36|||<|0.001|TWO_SIDED|95.0|1.56|3.17|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||3.17|1.56|<0.001
71007357|NCT00242710|141522956|SUPERIORITY_OR_OTHER||LS Mean Difference|3.78|||<|0.001|TWO_SIDED|95.0|2.81|4.76|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||4.76|2.81|<0.001
71102235|NCT02655601|141712408|SUPERIORITY||Odds Ratio (OR)|0.45||||0.465|ONE_SIDED||||||Fisher Exact|||With 78 and 71 patients in Arms A and B, respectively, there was 80% power with a one-tailed chi-square test (α=0.05) to detect a reduction in grade 3 or 4 thrombocytopenia from 15% in Arm B (without BMX-001) to 3.7% in Arm A (with BMX-001). Given the small number of patients that experienced low platelet counts or thrombocytopenia, a one-tailed Fisher's exact test was performed instead.||||0.465
71102236|NCT02655601|141712409|SUPERIORITY||Hazard Ratio (HR)|0.978||||0.911|ONE_SIDED||||||Log Rank|||A 1-tailed logrank test was conducted at the 0.2 level.||||0.911
71102237|NCT02655601|141712410|SUPERIORITY|||||||0.401|||||||Chi-squared, Corrected|A continuity adjusted Chi-Squared test was performed.||||||0.401
71007358|NCT00242710|141522958|SUPERIORITY_OR_OTHER||LS Mean Difference|1.61|||<|0.001|TWO_SIDED|95.0|0.97|2.24|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||2.24|0.97|<0.001
71007359|NCT00242710|141522958|SUPERIORITY_OR_OTHER||LS Mean Difference|1.82|||<|0.001|TWO_SIDED|95.0|1.19|2.46|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||2.46|1.19|<0.001
71007360|NCT00242710|141522958|SUPERIORITY_OR_OTHER||LS Mean Difference|2.46|||<|0.001|TWO_SIDED|95.0|1.69|3.23|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||3.23|1.69|<0.001
71007361|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|0.66||||0.373|TWO_SIDED|95.0|-0.8|2.12|||ANCOVA|||Week 1-4: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.12|-0.80|0.373
71007362|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|0.35||||0.738|TWO_SIDED|95.0|-1.7|2.4|||ANCOVA|||Week 5-8: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.40|-1.70|0.738
71007363|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|0.65||||0.539|TWO_SIDED|95.0|-1.41|2.71|||ANCOVA|||Week 9-12: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.71|-1.41|0.539
71007364|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09||||0.233|TWO_SIDED|95.0|-0.71|2.9|||ANCOVA|||Week 13-16: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.90|-0.71|0.233
71007365|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.605|TWO_SIDED|95.0|-1.39|2.39|||ANCOVA|||Week 17-20: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.39|-1.39|0.605
71007366|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|1.23||||0.305|TWO_SIDED|95.0|-1.12|3.57|||ANCOVA|||Week 21-24: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.57|-1.12|0.305
71007367|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|1.22||||0.299|TWO_SIDED|95.0|-1.08|3.52|||ANCOVA|||Week 25-28: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.52|-1.08|0.299
71007368|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|1.62||||0.092|TWO_SIDED|95.0|-0.27|3.51|||ANCOVA|||Week 29-32: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.51|-0.27|0.092
71007369|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|1.55||||0.08|TWO_SIDED|95.0|-0.18|3.29|||ANCOVA|||Week 33-36: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.29|-0.18|0.080
71007370|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|1.04||||0.279|TWO_SIDED|95.0|-0.85|2.92|||ANCOVA|||Week 37-40: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.92|-0.85|0.279
71007371|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|1.13||||0.26|TWO_SIDED|95.0|-0.84|3.11|||ANCOVA|||Week 41-44: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.11|-0.84|0.260
71102238|NCT01603368|141712435|OTHER|Student's t-test|||||=|0.001|||||||t-test, 2 sided|||||||=0.001
70925486|NCT02962895|141344520|SUPERIORITY||Least Squares Mean Difference|-1.92||||0.0921|TWO_SIDED|95.0|-4.15|0.32|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo||0.32|-4.15|0.0921
70925487|NCT02962895|141344522|SUPERIORITY||Least Squares Mean Difference|0.32||||0.4457|TWO_SIDED|95.0|-0.5|1.13|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo||1.13|-0.50|0.4457
70925488|NCT02962895|141344522|SUPERIORITY||Least Square Mean Difference|0.01||||0.301|TWO_SIDED|95.0|-0.79|0.82|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo||0.82|-0.79|0.301
71007372|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51||||0.618|TWO_SIDED|95.0|-1.5|2.52|||ANCOVA|||Week 45-48: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.52|-1.50|0.618
71007373|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.41||||0.81|TWO_SIDED|95.0|-3.78|2.96|||ANCOVA|||Week 49-52: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.96|-3.78|0.810
71007374|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34||||0.654|TWO_SIDED|95.0|-1.14|1.81|||ANCOVA|||Week 1-4: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||1.81|-1.14|0.654
71007375|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.834|TWO_SIDED|95.0|-1.84|2.28|||ANCOVA|||Week 5-8: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.28|-1.84|0.834
71007376|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34||||0.744|TWO_SIDED|95.0|-2.41|1.72|||ANCOVA|||Week 9-12: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||1.72|-2.41|0.744
71007377|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.909|TWO_SIDED|95.0|-1.7|1.91|||ANCOVA|||Week 13-16: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||1.91|-1.70|0.909
71007378|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.963|TWO_SIDED|95.0|-1.94|1.85|||ANCOVA|||Week 17-20: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||1.85|-1.94|0.963
71007379|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59||||0.625|TWO_SIDED|95.0|-1.77|2.94|||ANCOVA|||Week 21-24: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.94|-1.77|0.625
71007380|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.947|TWO_SIDED|95.0|-2.39|2.23|||ANCOVA|||Week 25-28: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.23|-2.39|0.947
71007381|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|0.64||||0.505|TWO_SIDED|95.0|-1.25|2.53|||ANCOVA|||Week 29-32: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.53|-1.25|0.505
71102239|NCT01251757|141712455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|||<|0.001|TWO_SIDED|95.0|0.011|0.034|||Regression, Linear|adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline statin adherence.|Adjusted difference in adherence for IVR group versus UC group, calculated as IVR - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||0.034|0.011|<.001
71007382|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51||||0.564|TWO_SIDED|95.0|-1.23|2.25|||ANCOVA|||Week 33-36: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.25|-1.23|0.564
71007383|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32||||0.739|TWO_SIDED|95.0|-2.21|1.57|||ANCOVA|||Week 37-40: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||1.57|-2.21|0.739
71007384|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.766|TWO_SIDED|95.0|-2.27|1.67|||ANCOVA|||Week 41-44: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||1.67|-2.27|0.766
71102240|NCT01251757|141712455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|||<|0.001|TWO_SIDED|95.0|0.019|0.042|||Regression, Linear|adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline statin adherence.|Adjusted difference in adherence for IVR+ group versus UC group, calculated as IVR+ - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||0.042|0.019|<.001
70925489|NCT02962895|141344522|SUPERIORITY||Least Square Mean Difference|-0.06||||0.8858|TWO_SIDED|95.0|-0.86|0.74|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo||0.74|-0.86|0.8858
70925490|NCT02962895|141344524|SUPERIORITY||Least Squares Mean Difference|-1.93||||0.3424|TWO_SIDED|95.0|-5.93|2.07|||Mixed Models Analysis|Confidence intervals and p-values are derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo||2.07|-5.93|0.3424
70925491|NCT02962895|141344524|SUPERIORITY||Least Squares Mean Difference|-2.56||||0.2092|TWO_SIDED|95.0|-6.58|1.45|||Mixed Models Analysis|Confidence intervals and p-values are derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo||1.45|-6.58|0.2092
70925492|NCT02962895|141344524|SUPERIORITY||Least Squares Mean Difference|0.31||||0.874|TWO_SIDED|95.0|-3.58|4.2|||Mixed Models Analysis|Confidence intervals and p-values are derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo||4.20|-3.58|0.8740
70925493|NCT02962895|141344526|SUPERIORITY||Least Squares Mean Difference|-1.02||||0.5768|TWO_SIDED|95.0|-4.61|2.57|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo / Mental Component Score||2.57|-4.61|0.5768
70925494|NCT02962895|141344526|SUPERIORITY||Least Squares Mean Difference|0.68||||0.7113|TWO_SIDED|95.0|-2.93|4.28|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo / Mental Component Score||4.28|-2.93|0.7113
70925495|NCT02962895|141344526|SUPERIORITY||Least Squares Mean Difference|1.0||||0.5722|TWO_SIDED|95.0|-2.49|4.48|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo / Mental Component Score||4.48|-2.49|0.5722
70925496|NCT02962895|141344526|SUPERIORITY||Least Squares Mean Difference|1.84||||0.4138|TWO_SIDED|95.0|-1.59|3.83|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo / Physical Component Score||3.83|-1.59|0.4138
71007385|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.931|TWO_SIDED|95.0|-1.92|2.1|||ANCOVA|||Week 45-48: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.10|-1.92|0.931
71007386|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19||||0.911|TWO_SIDED|95.0|-3.17|3.56|||ANCOVA|||Week 49-52: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.56|-3.17|0.911
71007387|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|2.61||||0.003|TWO_SIDED|95.0|0.92|4.3|||ANCOVA|||Week 1-4: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||4.30|0.92|0.003
70925497|NCT02962895|141344526|SUPERIORITY||Least Squares Mean Difference|-1.0||||0.4663|TWO_SIDED|95.0|-3.72|1.71|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo / Physical Component Score||1.71|-3.72|0.4663
71007388|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|4.18|||<|0.001|TWO_SIDED|95.0|1.79|6.58|||ANCOVA|||Week 5-8: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||6.58|1.79|<0.001
71007389|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|3.45||||0.005|TWO_SIDED|95.0|1.03|5.86|||ANCOVA|||Week 9-12: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||5.86|1.03|0.005
71007390|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|3.15||||0.004|TWO_SIDED|95.0|1.01|5.3|||ANCOVA|||Week 13-16: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||5.30|1.01|0.004
71007391|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|2.61||||0.023|TWO_SIDED|95.0|0.36|4.87|||ANCOVA|||Week 17-20: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||4.87|0.36|0.023
71007392|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|3.75||||0.008|TWO_SIDED|95.0|0.96|6.54|||ANCOVA|||Week 21-24: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||6.54|0.96|0.008
71007393|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|3.52||||0.012|TWO_SIDED|95.0|0.78|6.26|||ANCOVA|||Week 25-28: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||6.26|0.78|0.012
71007394|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|3.81|||<|0.001|TWO_SIDED|95.0|1.55|6.07|||ANCOVA|||Week 29-32: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||6.07|1.55|<0.001
71007395|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|3.75|||<|0.001|TWO_SIDED|95.0|1.68|5.83|||ANCOVA|||Week 33-36: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||5.83|1.68|<0.001
71007396|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3||||0.004|TWO_SIDED|95.0|1.05|5.54|||ANCOVA|||Week 37-40: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||5.54|1.05|0.004
71007397|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|1.63||||0.175|TWO_SIDED|95.0|-0.73|3.99|||ANCOVA|||Week 41-44: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.99|-0.73|0.175
71007398|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|1.35||||0.27|TWO_SIDED|95.0|-1.05|3.75|||ANCOVA|||Week 45-48: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.75|-1.05|0.270
70925498|NCT02962895|141344526|SUPERIORITY||Least Squares Mean Difference|1.84||||0.1694|TWO_SIDED|95.0|-0.79|4.47|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo / Physical Component Score||4.47|-0.79|0.1694
70925499|NCT02962895|141344528|SUPERIORITY||Least Squares Mean Difference|-4.17||||0.2671|TWO_SIDED|95.0|-11.56|3.22|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo||3.22|-11.56|0.2671
70925500|NCT02962895|141344528|SUPERIORITY||Least Squares Mean Difference|-4.49||||0.2248|TWO_SIDED|95.0|-11.78|2.79|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo||2.79|-11.78|0.2248
70925501|NCT02962895|141344528|SUPERIORITY||Least Squares Mean Difference|-8.36||||0.0224|TWO_SIDED|95.0|-15.51|-1.2|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo||-1.20|-15.51|0.0224
70925502|NCT02962895|141344530|SUPERIORITY||Least Squares Mean Difference|2.27||||0.6457|TWO_SIDED|95.0|-7.46|12.0|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo||12.00|-7.46|0.6457
70925503|NCT02962895|141344530|SUPERIORITY||Least Squares Mean Difference|3.26||||0.5132|TWO_SIDED|95.0|-6.55|13.06|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo||13.06|-6.55|0.5132
71007399|NCT00242710|141522959|SUPERIORITY_OR_OTHER||LS Mean Difference|3.78||||0.077|TWO_SIDED|95.0|-0.41|7.97|||ANCOVA|||Week 49-52: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||7.97|-0.41|0.077
71007400|NCT00242710|141522960|SUPERIORITY_OR_OTHER|||||||0.826|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||0.826
71007401|NCT00242710|141522960|SUPERIORITY_OR_OTHER|||||||0.534|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||0.534
71007402|NCT00242710|141522960|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||1.000
71007403|NCT00242710|141522960|SUPERIORITY_OR_OTHER|||||||0.516|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||0.516
71007404|NCT00242710|141522960|SUPERIORITY_OR_OTHER|||||||0.446|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||0.446
71007405|NCT00242710|141522960|SUPERIORITY_OR_OTHER|||||||0.218|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||0.218
71102241|NCT01251757|141712456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016||||0.022|TWO_SIDED|95.0|0.002|0.029|||Regression, Linear|Adjusted for site, gender, age, total number of prescription medications participant was taking, comorbid diabetes/CVD, baseline ACEI/ARB adherence.|Adjusted difference in adherence for IVR+ group versus UC group, calculated as IVR+ - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||0.029|0.002|0.022
71007406|NCT00242710|141522960|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||1.000
71007407|NCT00242710|141522960|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||1.000
71007408|NCT00242710|141522960|SUPERIORITY_OR_OTHER|||||||0.733|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||0.733
71007409|NCT00242710|141522960|SUPERIORITY_OR_OTHER|||||||0.736|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||0.736
71007410|NCT00242710|141522960|SUPERIORITY_OR_OTHER|||||||0.449|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||0.449
71007411|NCT00242710|141522960|SUPERIORITY_OR_OTHER|||||||0.489|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||0.489
71007412|NCT00242710|141522960|SUPERIORITY_OR_OTHER|||||||0.163|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||0.163
71007413|NCT00242710|141522960|SUPERIORITY_OR_OTHER|||||||0.813|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||0.813
71007414|NCT00242710|141522960|SUPERIORITY_OR_OTHER|||||||0.777|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||0.777
71007415|NCT00242710|141522960|SUPERIORITY_OR_OTHER|||||||0.448|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||0.448
71007416|NCT00242710|141522960|SUPERIORITY_OR_OTHER|||||||0.507|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||0.507
71007417|NCT00242710|141522960|SUPERIORITY_OR_OTHER|||||||0.669|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||0.669
71007418|NCT00242710|141522960|SUPERIORITY_OR_OTHER|||||||0.281|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||0.281
71007419|NCT00242710|141522960|SUPERIORITY_OR_OTHER|||||||0.689|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||0.689
71007420|NCT00242710|141522960|SUPERIORITY_OR_OTHER|||||||0.437|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||0.437
71007421|NCT00242710|141522960|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||1.000
71007422|NCT00242710|141522960|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||1.000
71007423|NCT00242710|141522960|SUPERIORITY_OR_OTHER|||||||0.227|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||0.227
71007424|NCT00242710|141522960|SUPERIORITY_OR_OTHER|||||||0.758|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||0.758
71007425|NCT00242710|141522960|SUPERIORITY_OR_OTHER|||||||0.554|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||0.554
71007426|NCT00242710|141522960|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||<0.001
71007427|NCT00242710|141522960|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||<0.001
71007428|NCT00242710|141522960|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||<0.001
71007429|NCT00242710|141522960|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||<0.001
71007430|NCT00242710|141522960|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||<0.001
71007431|NCT00242710|141522960|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||<0.001
71007432|NCT00242710|141522960|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||0.008
71007433|NCT00242710|141522960|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||<0.001
71007434|NCT00242710|141522960|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||0.005
71007435|NCT00242710|141522960|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||0.008
71007436|NCT00242710|141522960|SUPERIORITY_OR_OTHER|||||||0.062|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||0.062
71007437|NCT00242710|141522960|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||0.007
71007438|NCT00242710|141522960|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||0.029
71007439|NCT00242710|141522962|SUPERIORITY_OR_OTHER||LS Mean Difference|3.25|||<|0.001|TWO_SIDED|95.0|1.92|4.58|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||4.58|1.92|<0.001
71045252|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0011|TWO_SIDED|95.0|1.26|2.5|||Regression, Logistic|||Week 16, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.50|1.26|0.0011
71045253|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0035|TWO_SIDED|95.0|1.19|2.38|||Regression, Logistic|||Week 16, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.38|1.19|0.0035
71007440|NCT00242710|141522962|SUPERIORITY_OR_OTHER||LS Mean Difference|3.14|||<|0.001|TWO_SIDED|95.0|1.83|4.46|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||4.46|1.83|<0.001
71007441|NCT00242710|141522962|SUPERIORITY_OR_OTHER||LS Mean Difference|4.68|||<|0.001|TWO_SIDED|95.0|3.13|6.23|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||6.23|3.13|<0.001
71007442|NCT00242710|141522963|SUPERIORITY_OR_OTHER||LS Mean Difference|1.83|||<|0.001|TWO_SIDED|95.0|0.8|2.87|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||2.87|0.80|<0.001
71007443|NCT00242710|141522963|SUPERIORITY_OR_OTHER||LS Mean Difference|1.94|||<|0.001|TWO_SIDED|95.0|0.92|2.97|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||2.97|0.92|<0.001
71007444|NCT00242710|141522963|SUPERIORITY_OR_OTHER||LS Mean Difference|2.38|||<|0.001|TWO_SIDED|95.0|1.17|3.59|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||3.59|1.17|<0.001
71007445|NCT00886587|141523006|SUPERIORITY_OR_OTHER||Estimated Mean Difference|0.04||||0.9416|TWO_SIDED|95.0|-1.09|1.17||The significance threshold level was 0.05 (two-sided).|Repeated measures ANCOVA|Treatment, visit number, and treatment-visit number interaction term as factors, with baseline score and age as covariates.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.17|-1.09|0.9416
71045254|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0022|TWO_SIDED|95.0|1.22|2.43|||Regression, Logistic|||Week 16, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.43|1.22|0.0022
71045255|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0155|TWO_SIDED|95.0|1.11|2.72|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.72|1.11|0.0155
71045256|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|1.39||||0.1549|TWO_SIDED|95.0|0.88|2.2|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.20|0.88|0.1549
71045257|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|2.94||||0.0212|TWO_SIDED|95.0|1.18|7.37|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||7.37|1.18|0.0212
71007446|NCT00886587|141523007|SUPERIORITY_OR_OTHER||Estimated Mean Difference|0.35||||0.5431|TWO_SIDED|95.0|-0.78|1.48||The significance level threshold level was 0.05 (two-sided).|Repeated measures ANCOVA|Treatment, visit number, and treatment-visit number interaction term as factors, with baseline score and age as covariates.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.48|-0.78|0.5431
71007447|NCT00886587|141523008|SUPERIORITY_OR_OTHER||Estimated Mean Difference|-0.06||||0.788|TWO_SIDED|95.0|-0.47|0.36||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment as a factor, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.36|-0.47|0.788
71007448|NCT00886587|141523009|SUPERIORITY_OR_OTHER||Estimated Mean Difference|0.03||||0.9508|TWO_SIDED|95.0|-0.9|0.96||The significance threshold level was 0.05 (two-sided).|Repeated measures ANCOVA|Treatment, visit number, and treatment-visit number interaction term as factors, with baseline score and age as covariates.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.96|-0.90|0.9508
71007449|NCT03490734|141523010|SUPERIORITY|||||||0.52||||||Corrected for multiple comparisons by using the threshold free cluster enhancement, nonparametric thresholding algorithm in FMRIB Software Library (FSL), resulting in a family-wise error rate (FWE) corrected significance threshold of p-FWE\<0.05|ANCOVA|||Whole-brain analyses were used. No clusters of significant activation were detected.||||0.52
71007450|NCT03490734|141523011|SUPERIORITY|||||||0.016||||||Corrected for multiple comparisons by using the threshold free cluster enhancement (TFCE), nonparametric thresholding algorithm in FSL, resulting in a family-wise error rate corrected significance threshold of p-FWE \< 0.05|ANCOVA|||||||0.016
71007451|NCT00374452|141523035|OTHER||||||>|0.1|||||||Mixed Models Analysis|||We compared the mean percentages of events per clinician between study arms, using mixed model regression adjusting for medical center, clinic type (community-based clinic vs not), clinician discipline (MD vs non-MD), presence of pharmacist in the clinic, and mean age of clinician's panels of patients as fixed effects, and clinic as a random effect to account for clustering of clinicians within clinics.||||>0.1
71007452|NCT03099304|141523050|SUPERIORITY||Odds Ratio (OR)|13.79||||0.0057|TWO_SIDED|95.0|1.73|640.85||The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression|||||640.85|1.73|0.0057
71007453|NCT03099304|141523050|SUPERIORITY||Odds Ratio (OR)|10.3||||0.0243|TWO_SIDED|95.0|1.24|487.28||The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression|||||487.28|1.24|0.0243
71007454|NCT03099304|141523050|SUPERIORITY||Odds Ratio (OR)|28.48|||<|0.0001|TWO_SIDED|95.0|3.74|1305.2||The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression|||||1305.2|3.74|<0.0001
71007455|NCT03099304|141523050|SUPERIORITY||Odds Ratio (OR)|24.66||||0.0001|TWO_SIDED|95.0|3.28|1121.4||The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression|||||1121.4|3.28|0.0001
71007456|NCT03099304|141523051|SUPERIORITY||Odds Ratio (OR)|1.03||||0.4936|TWO_SIDED|95.0|0.05||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression||||||0.05|0.4936
71007457|NCT03099304|141523051|SUPERIORITY||Odds Ratio (OR)|4.16||||0.114|TWO_SIDED|95.0|0.62||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression||||||0.62|0.1140
71007458|NCT03099304|141523051|SUPERIORITY||Odds Ratio (OR)|6.1||||0.0501|TWO_SIDED|95.0|1.0||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression||||||1.00|0.0501
71007459|NCT03099304|141523051|SUPERIORITY||Odds Ratio (OR)|3.89||||0.1257|TWO_SIDED|95.0|0.58||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression||||||0.58|0.1257
71007460|NCT03099304|141523052|SUPERIORITY||Odds Ratio (OR)|1.19||||0.9794|TWO_SIDED|95.0|0.33|4.33|||exact logistic regression|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).||||4.33|0.33|0.9794
71007461|NCT03099304|141523052|SUPERIORITY||Odds Ratio (OR)|1.69||||0.4893|TWO_SIDED|95.0|0.51|5.86|||exact logistic regression|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).||||5.86|0.51|0.4893
71007462|NCT03099304|141523059|SUPERIORITY||Least squares mean (LSM) difference|-0.44|STANDARD_ERROR_OF_MEAN|0.16||0.0056|TWO_SIDED|95.0|-0.75|-0.13|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-0.13|-0.75|0.0056
71007463|NCT03099304|141523059|SUPERIORITY||LSM difference|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.0095|TWO_SIDED|95.0|-0.7|-0.1|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-0.10|-0.70|0.0095
71007464|NCT03099304|141523059|SUPERIORITY||LSM difference|-0.68|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-0.99|-0.37|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-0.37|-0.99|<0.0001
71045258|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0373|TWO_SIDED|95.0|1.06|6.57|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||6.57|1.06|0.0373
71007465|NCT03099304|141523059|SUPERIORITY||LSM difference|-0.51|STANDARD_ERROR_OF_MEAN|0.15||0.0011|TWO_SIDED|95.0|-0.8|-0.21|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-0.21|-0.80|0.0011
71007466|NCT03099304|141523061|SUPERIORITY||LSM difference|-36.71|STANDARD_ERROR_OF_MEAN|10.34||0.0005|TWO_SIDED|95.0|-57.15|-16.27|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-16.27|-57.15|0.0005
71007467|NCT03099304|141523061|SUPERIORITY||LM difference|-35.12|STANDARD_ERROR_OF_MEAN|10.01||0.0006|TWO_SIDED|95.0|-54.91|-15.33|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-15.33|-54.91|0.0006
71007468|NCT03099304|141523061|SUPERIORITY||LSM difference|-46.02|STANDARD_ERROR_OF_MEAN|10.35|<|0.0001|TWO_SIDED|95.0|-66.47|-25.57|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-25.57|-66.47|<0.0001
71007469|NCT03099304|141523061|SUPERIORITY||LSM difference|-43.8|STANDARD_ERROR_OF_MEAN|9.98|<|0.0001|TWO_SIDED|95.0|-63.52|-24.07|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-24.07|-63.52|<0.0001
71007470|NCT03099304|141523068|SUPERIORITY||LSM difference|-2.84|STANDARD_ERROR_OF_MEAN|1.32||0.0326|TWO_SIDED|95.0|-5.44|-0.24|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-0.24|-5.44|0.0326
71007471|NCT03099304|141523068|SUPERIORITY||LSM difference|-2.74|STANDARD_ERROR_OF_MEAN|1.28||0.0333|TWO_SIDED|95.0|-5.26|-0.22|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-0.22|-5.26|0.0333
71007472|NCT03099304|141523068|SUPERIORITY||LSM difference|-5.08|STANDARD_ERROR_OF_MEAN|1.31||0.0002|TWO_SIDED|95.0|-7.68|-2.48|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-2.48|-7.68|0.0002
71007473|NCT03099304|141523068|SUPERIORITY||LSM difference|-4.08|STANDARD_ERROR_OF_MEAN|1.27||0.0016|TWO_SIDED|95.0|-6.59|-1.57|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-1.57|-6.59|0.0016
71007474|NCT03099304|141523070|SUPERIORITY||LSM difference|-23.53|STANDARD_ERROR_OF_MEAN|6.99||0.001|TWO_SIDED|95.0|-37.35|-9.71|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-9.71|-37.35|0.0010
71007475|NCT03099304|141523070|SUPERIORITY||LSM difference|-18.47|STANDARD_ERROR_OF_MEAN|6.77||0.0072|TWO_SIDED|95.0|-31.86|-5.08|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-5.08|-31.86|0.0072
71007476|NCT03099304|141523070|SUPERIORITY||LSM difference|-29.81|STANDARD_ERROR_OF_MEAN|6.98|<|0.0001|TWO_SIDED|95.0|-43.61|-16.0|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-16.00|-43.61|<0.0001
71007477|NCT03099304|141523070|SUPERIORITY||LSM difference|-25.56|STANDARD_ERROR_OF_MEAN|6.75||0.0002|TWO_SIDED|95.0|-38.89|-12.22|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-12.22|-38.89|0.0002
71007478|NCT03099304|141523082|SUPERIORITY||Odds Ratio (OR)|1.03||||0.4936|TWO_SIDED|95.0|0.05||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.||exact logistic regression|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|||||0.05|0.4936
71007479|NCT03099304|141523082|SUPERIORITY||Odds Ratio (OR)|4.16||||0.114|TWO_SIDED|95.0|0.62||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.||exact logistic regression|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|||||0.62|0.1140
71007480|NCT03099304|141523082|SUPERIORITY||Odds Ratio (OR)|6.1||||0.0501|TWO_SIDED|95.0|1.0||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.||exact logistic regression|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|||||1.00|0.0501
71007481|NCT03099304|141523082|SUPERIORITY||Odds Ratio (OR)|3.89||||0.1257|TWO_SIDED|95.0|0.58||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.||exact logistic regression|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|||||0.58|0.1257
71007482|NCT01401101|141523099|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED|95.0||||Jointly modeled outcomes at the 3 waves by time, condition, and timeXcondition, to allow for different effects at 6 and 12 mos; controlled for interview mode (phone vs. in-person); used random effects to account for correlations wi/in site \& patient.|Regression, Linear|||Intent-to-treat (ITT) analysis using the linear mixed-method model to estimate the difference between the PCM and TAU conditions||||0.97
71007483|NCT01401101|141523100|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED|95.0|||||Regression, Linear|||Intent-to-treat (ITT) analysis using the linear mixed-method model to estimate the difference between the PCM and TAU conditions||||0.54
71007484|NCT01401101|141523101|SUPERIORITY_OR_OTHER|||||||0.33||||||Jointly modeled outcomes at the 3 waves by time, condition, and timeXcondition, to allow for different effects at 6 and 12 mos; controlled for interview mode (phone vs. in-person); using random effects to control for correlations w/in site \& patient.|Regression, Linear|||Intent-to-treat (ITT) analysis using the linear mixed-method model to estimate the difference between the PCM and TAU conditions||||0.33
71007485|NCT02313506|141523116|SUPERIORITY||Mean Difference (Net)|-31.1||||0.02|TWO_SIDED|95.0|-56.6|-5.7||No adjustment was made for multiple comparisons because Type II error is a greater concern than Type I error in feasibility studies.|ANCOVA|||ANCOVA was performed to evaluate the effect of the group type on the outcome measures after adjusting for blocking and baseline (T0). We assessed 3 planned contrasts of changes in outcome measures over time. Contrast 1 compared T0-T1 between the 2 groups to determine if the intervention was superior to the control.||-5.7|-56.6|0.02
70925504|NCT02962895|141344530|SUPERIORITY||Least Squares Mean Difference|-4.77||||95|TWO_SIDED|95.0|-14.21|4.68|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo||4.68|-14.21|95
71007486|NCT02313506|141523116|SUPERIORITY||Mean Difference (Net)|4.6||||0.71|TWO_SIDED|95.0|-19.6|28.9|||ANCOVA|||ANCOVA was performed to evaluate the effect of the group type on the outcome measures after adjusting for blocking and baseline (T0). We assessed 3 planned contrasts of changes in outcome measures over time. Contrast 2 compared T0-T1 in the immediate group against T1-T2 in the delayed group.||28.9|-19.6|0.71
71007487|NCT02313506|141523116|SUPERIORITY||Mean Difference (Net)|-11.0||||0.29|TWO_SIDED|95.0|-31.1|9.1|||ANCOVA|||ANCOVA was performed to evaluate the effect of the group type on the outcome measures after adjusting for blocking and baseline (T0). We assessed 3 planned contrasts of changes in outcome measures over time. Contrast 3 compared T0-T1 in the immediate group against T0-T2 in the delayed group.||9.1|-31.1|0.29
71007488|NCT01202643|141523172|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||ANCOVA|||||||0.67
71007489|NCT01202643|141523173|SUPERIORITY_OR_OTHER|||||||0.74|||||||Chi-squared, Corrected|||Study was closed due to insufficient recruitment||||0.74
71007490|NCT03198884|141523174|OTHER|The percent of patients with an RNA \<50 copies/mL at each time point was analyzed using McNemar's test following the guidelines of the Snapshot algorithm. Missing RNA data was considered a treatment failure. Change in mean serum creatinine from baseline was analyzed using Wilcoxon signed rank test.|||||<|0.05|||||||McNemar||||Change in mean CD4+ cell counts from baseline was analyzed using a paired t-test. All analyses used a p-value of less than or equal to 0.05 as significant. Statistical analyses were performed using R software, version 3.4.3.|||<0.05
71007491|NCT03198884|141523175|OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70925505|NCT02962895|141344531|SUPERIORITY||Least Squares Mean Difference|0.11||||0.271|TWO_SIDED|95.0|-0.08|0.3|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo (Stimulated salivary flow rate)||0.30|-0.08|0.2710
71007492|NCT03049852|141523181|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71007493|NCT03049852|141523183|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.007|TWO_SIDED||||||ANOVA|||||||0.007
71007494|NCT03860181|141523197|EQUIVALENCE|The statistical significance's p-value was set at 0.05. For Surgeon 1's differences, they were calculated as patient POSAS score - surgeon POSAS score, with a negative difference signifying that the patients thought more highly of the scars than the physicians since lower POSAS scores are more favorable.||||||0.896|||||||Wilcoxon (Mann-Whitney)|Mann-Whitney U = 215||||||0.896
71007495|NCT03860181|141523197|EQUIVALENCE|The statistical significance's p-value was set at 0.05. For Surgeon 2's differences, they were calculated as patient POSAS score - surgeon POSAS score, with a negative difference signifying that the patients thought more highly of the scars than the physicians since lower POSAS scores are more favorable.||||||0.612|||||||Wilcoxon (Mann-Whitney)|Mann-Whitney U = 210||||||0.612
71007496|NCT01385098|141523215|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
70925506|NCT02962895|141344531|SUPERIORITY||Least Squares Mean Difference|0.13||||0.1618|TWO_SIDED|95.0|-0.05|0.32|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo (Stimulated salivary flow rate)||0.32|-0.05|0.1618
70925507|NCT02962895|141344531|SUPERIORITY||Least Squares Mean Difference|0.2||||0.0374|TWO_SIDED|95.0|0.01|0.38|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo (Stimulated salivary flow rate)||0.38|0.01|0.0374
71007497|NCT01385098|141523216|SUPERIORITY_OR_OTHER|||||||0.013||||||Change from preoperative to 12 weeks|Wilcoxon (Mann-Whitney)|||||||0.013
71007498|NCT01385098|141523216|SUPERIORITY_OR_OTHER|||||||0.01||||||Change from preoperative to 12 weeks|Wilcoxon (Mann-Whitney)|||||||0.010
71007499|NCT00410514|141523218|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was -3 mL/sec for Qmax. Mirabegron was considered non-inferior to placebo for Qmax if the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was greater than -3 mL/sec.|LS Mean Difference|0.4|||||TWO_SIDED|95.0|-0.63|1.42|||ANCOVA||Treatment groups were compared using ANCOVA with pooled center and treatment as factors and the baseline value as a covariate. Centers with less than 12 patients were pooled before the analysis.|The study was designed to show non-inferiority of mirabegron compared to placebo for both primary outcome measures. The comparison between mirabegron 50 mg and placebo was conducted first. If non-inferiority was demonstrated in this comparison, mirabegron 100 mg was compared to placebo. However, if the first comparison did not demonstrate non-inferiority, no further comparison was made. This procedure maintained the overall type I error of one-sided 2.5%.||1.42|-0.63|
71007500|NCT00410514|141523218|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was -3 mL/sec for Qmax. Mirabegron was considered non-inferior to placebo for Qmax if the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was greater than -3 mL/sec.|LS Mean Difference|0.62|||||TWO_SIDED|95.0|-0.43|1.68|||ANCOVA||Treatment groups were compared using ANCOVA with pooled center and treatment as factors and the baseline value as a covariate. Centers with less than 12 patients were pooled before the analysis.|The study was designed to show non-inferiority of mirabegron compared to placebo for both primary outcome measures. The comparison between mirabegron 50 mg and placebo was conducted first. If non-inferiority was demonstrated in this comparison, mirabegron 100 mg was compared to placebo. However, if the first comparison did not demonstrate non-inferiority, no further comparison was made. This procedure maintained the overall type I error of one-sided 2.5%.||1.68|-0.43|
71008696|NCT02055976|141525243|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.264|STANDARD_ERROR_OF_MEAN|2.072||0.006|TWO_SIDED|95.0|1.147|9.38|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.380|1.147|0.006
71102242|NCT01251757|141712456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|||<|0.001|TWO_SIDED|95.0|0.023|0.05|||Regression, Linear|Adjusted for site, gender, age, total number of prescription medications participant was taking, comorbid diabetes/CVD, baseline ACEI/ARB adherence.|Adjusted difference in adherence for IVR+ group versus UC group, calculated as IVR+ - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||0.050|0.023|<.001
71102243|NCT01251757|141712457|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.002|TWO_SIDED|95.0|1.05|1.24||Adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline statin adherence.|Regression, Logistic||Adjusted odds ratio for good adherence in IVR group versus UC group, calculated as IVR - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||1.24|1.05|0.002
71102244|NCT01251757|141712457|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16|||<|0.001|TWO_SIDED|95.0|1.06|1.26||Adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline statin adherence.|Regression, Logistic||Adjusted odds ratio for good adherence in IVR+ group versus UC group, calculated as IVR+ - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||1.26|1.06|<0.001
71102245|NCT01251757|141712458|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.014|TWO_SIDED|95.0|1.02|1.23||adjusted for site, gender, age, total number of prescription medications participant was taking, comorbid diabetes/CVD, baseline ACEI/ARB adherence|Regression, Logistic||Adjusted odds ratio for good adherence in IVR group versus UC group, calculated as IVR - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||1.23|1.02|0.014
71102246|NCT01251757|141712458|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21|||<|0.001|TWO_SIDED|95.0|1.1|1.32||Adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline statin adherence.|Regression, Logistic||Adjusted odds ratio for good adherence in IVR group versus UC group, calculated as IVR - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||1.32|1.10|<0.001
71102247|NCT01251757|141712459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.041|TWO_SIDED|95.0|-1.0|0.0||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Linear|Adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline SBP group.||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline SBP level groups.||0.0|-1.0|.041
70925508|NCT02962895|141344531|SUPERIORITY||Least Squares Mean Difference|0.0||||0.9559|TWO_SIDED|95.0|-0.09|0.09|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo (Unstimulated salivary flow rate)||0.09|-0.09|0.9559
70925509|NCT02962895|141344531|SUPERIORITY||Least Squares Mean Difference|0.0||||0.929|TWO_SIDED|95.0|-0.09|0.08|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo (Unstimulated salivary flow rate)||0.08|-0.09|0.9290
70925510|NCT02962895|141344531|SUPERIORITY||Least Squares Mean Difference|-0.01||||0.7276|TWO_SIDED|95.0|-0.1|0.07|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo (Unstimulated salivary flow rate)||0.07|-0.10|0.7276
70925511|NCT05894577|141344535|SUPERIORITY|Posterior probability of efficacy (P(HR\>1))|Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.92|1.12|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.12|0.92|
71007501|NCT00410514|141523220|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 15 cmH2O for PdetQmax. Mirabegron was considered non-inferior to placebo for PdetQmax if the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was less than 15 cmH2O.|LS Mean Difference|-5.94|||||TWO_SIDED|95.0|-13.98|2.09|||ANCOVA||Treatment groups were compared using ANCOVA with pooled center and treatment as factors and the baseline value as a covariate. Centers with less than 12 patients were pooled before the analysis.|The study was designed to show non-inferiority of mirabegron compared to placebo for both primary outcome measures. The comparison between mirabegron 50 mg and placebo was conducted first. If non-inferiority was demonstrated in this comparison, mirabegron 100 mg was compared to placebo. However, if the first comparison did not demonstrate non-inferiority, no further comparison was made. This procedure maintained the overall type I error of one-sided 2.5%.||2.09|-13.98|
71007502|NCT00410514|141523220|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 15 cmH2O for PdetQmax. Mirabegron was considered non-inferior to placebo for PdetQmax if the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was less than 15 cmH2O.|LS Mean Difference|-1.39|||||TWO_SIDED|95.0|-9.73|6.96|||ANCOVA||Treatment groups were compared using ANCOVA with pooled center and treatment as factors and the baseline value as a covariate. Centers with less than 12 patients were pooled before the analysis.|The study was designed to show non-inferiority of mirabegron compared to placebo for both primary outcome measures. The comparison between mirabegron 50 mg and placebo was conducted first. If non-inferiority was demonstrated in this comparison, mirabegron 100 mg was compared to placebo. However, if the first comparison did not demonstrate non-inferiority, no further comparison was made. This procedure maintained the overall type I error of one-sided 2.5%.||6.96|-9.73|
71007503|NCT05466240|141523335|EQUIVALENCE|For each post-baseline collection time point, treatment difference and p-value comparing the mean change in viral load from baseline between treatment arms from an analysis of covariance model with covariate baseline viral load.|||||<|0.95|||||||ANCOVA|||||||<0.95
71007504|NCT01749930|141523353|NON_INFERIORITY|The 2 treatments were compared for each time point by visit. LS mean of each treatment group, the difference in the LS mean, and the 2-sided 95% CI for the difference were obtained. Noninferiority could be claimed if the upper limit of the CIs \<1.5 mmHg at all time points of each visit and \<1.00 mmHg for at least 5 out of the 9 time points. If noninferiority was determined, superiority at each time point could be claimed if the upper limit of the 95% CI\<0 mmHg at all time points of each visit.||||||0.216||||||The ANCOVA results for the comparison of LS means of mean IOP between treatment groups demonstrated noninferiority of BOL-303259-X to timolol. Superiority of BOL-303259-X to timolol was demonstrated at 8 of 9 time points (exception at 8 am Week 2).|ANCOVA|||||||0.216
71007505|NCT01749930|141523354|OTHER|||||||0.084|||||||Chi-squared|||||||0.084
71007506|NCT01749930|141523355|OTHER|||||||0.007|||||||Chi-squared|||||||0.007
71007507|NCT01749930|141523356|OTHER||||||||||||||||||No statistical analysis was performed on these proportions|||
71007508|NCT04735432|141523357|NON_INFERIORITY|This was a phase 3, multicenter, randomized, open-label, parallel-group, 12-week study to evaluate the noninferiority of the pharmacodynamic effect of efgartigimod PH20 SC 1000 mg compared with efgartigimod IV 10 mg/kg in patients with generalized myasthenia gravis.|LS mean difference|-4.2|STANDARD_ERROR_OF_MEAN|1.782|<|0.0001|TWO_SIDED|95.0|-7.73|-0.66|||ANCOVA|||The primary endpoint was analyzed using an ANCOVA model with treatment as a factor and total IgG levels at baseline as a covariate. The NI evaluation was based on a percent reduction from baseline in total IgG levels at day 29 (week 4) using an NI margin of 10%. Only the results for mITT analysis set are entered.||-0.66|-7.73|< 0.0001
71007509|NCT00945945|141523424|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.34||||0.105|TWO_SIDED|95.0|-0.07|0.75||P-value for Change from Baseline to Endpoint (BOCF).|ANCOVA|Main Effect Model: Change = Treatment + Pooled Investigator + Baseline (Type III sums of squares).|Least Squares Mean Difference = DLX30-PLA minus PLA-DLX60.|||0.75|-0.07|0.105
71007510|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.596||||0.0045|TWO_SIDED|95.0|1.704|18.378|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (ASIAN vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week \[Wk\] 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||18.378|1.704|0.0045
71007511|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.989||||0.9755|TWO_SIDED|95.0|0.497|1.967|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (BLACK vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.967|0.497|0.9755
71007512|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.743||||0.4786|TWO_SIDED|95.0|0.327|1.688|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (HISPANIC vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.688|0.327|0.4786
71007513|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.38||||0.014|TWO_SIDED|95.0|1.405|20.597|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (OTHER vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||20.597|1.405|0.0140
71045259|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0006|TWO_SIDED|95.0|1.29|2.57|||Regression, Logistic|||Week 24, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.57|1.29|0.0006
71045260|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|2.13|||<|0.0001|TWO_SIDED|95.0|1.51|3.02|||Regression, Logistic|||Week 24, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.02|1.51|<.0001
70925512|NCT05894577|141344536|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.14|7.07|||||Low event rate precluded covariate adjustment.|No hypothesis test or decision rule was evaluated.||7.07|0.14|
70925513|NCT05894577|141344539|SUPERIORITY|Posterior probability of efficacy (P(HR\<1))|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.45|1.84|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.84|0.45|
70925514|NCT05894577|141344540|SUPERIORITY|Posterior probability of efficacy (P(OR\<1))|Odds Ratio (OR)|1.31|||||TWO_SIDED|95.0|0.5|2.29|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||2.29|0.50|
70925515|NCT05894577|141344541|SUPERIORITY|Posterior probability of efficacy (P(OR\<1))|Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.16|1.49|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.49|0.16|
71102248|NCT01251757|141712459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.93|TWO_SIDED|95.0|-0.5|0.5||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Linear|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline SBP group.||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline SBP level groups.||.5|-.5|.93
71102249|NCT01251757|141712460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.404|TWO_SIDED|95.0|0.93|1.19||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Logistic|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline SBP group||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline SBP level groups.||1.19|0.93|.404
70925516|NCT05894577|141344542|SUPERIORITY|Posterior probability of efficacy (P(OR\<1))|Odds Ratio (OR)|1.48|||||TWO_SIDED|95.0|0.33|2.96|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||2.96|0.33|
70925517|NCT05894577|141344543|OTHER||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.71|1.31|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.31|0.71|
70925518|NCT05894577|141344543|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.75|1.51|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.51|0.75|
70925519|NCT05894577|141344543|OTHER||Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|0.84|1.88|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.88|0.84|
70925520|NCT05894577|141344543|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.65|1.6|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.60|0.65|
71007514|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.078|||<|0.0001|TWO_SIDED|95.0|1.062|1.094|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.094|1.062|<0.0001
71007515|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.136||||0.0035|TWO_SIDED|95.0|1.819|20.701|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (ASIAN vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||20.701|1.819|0.0035
71007516|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.903||||0.7821|TWO_SIDED|95.0|0.439|1.857|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (BLACK vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.857|0.439|0.7821
71007517|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.4846|TWO_SIDED|95.0|0.317|1.723|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (HISPANIC vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.723|0.317|0.4846
71007518|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.424||||0.017|TWO_SIDED|95.0|1.353|21.749|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (OTHER vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||21.749|1.353|0.0170
71007519|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.695||||0.0125|TWO_SIDED|95.0|0.523|0.925|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.925|0.523|0.0125
71007520|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.472||||0.0139|TWO_SIDED|95.0|1.288|9.357|||Regression, Logistic|||The statistical analysis is presented for average number of drinks per week (1 vs 0). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||9.357|1.288|0.0139
71007521|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.179||||0.6327|TWO_SIDED|95.0|0.601|2.311|||Regression, Logistic|||The statistical analysis is presented for average number of drinks per week (\> 1 vs 0). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.311|0.601|0.6327
71007522|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.061|||<|0.0001|TWO_SIDED|95.0|1.042|1.08|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.080|1.042|<0.0001
71007523|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.185||||0.0033|TWO_SIDED|95.0|1.058|1.326|||Regression, Logistic|||The statistical analysis is presented for Cumulative PEG-IFN alfa-2a dose per 1000 ug. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.326|1.058|0.0033
71102250|NCT01251757|141712460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.54|TWO_SIDED|95.0|0.85|1.09||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Logistic|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline SBP group||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline SBP level groups.||1.09|.85|.54
71102251|NCT01251757|141712461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.38|TWO_SIDED|95.0|-1.8|0.7||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Linear|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline LDL group.||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline LDL subgroups.||0.7|-1.8|.38
71007524|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.227|||<|0.0001|TWO_SIDED|95.0|1.151|1.308|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.308|1.151|<0.0001
70925521|NCT05894577|141344543|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.57|1.36|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.36|0.57|
71007525|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.814||||0.0289|TWO_SIDED|95.0|0.676|0.979|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, 1st 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.979|0.676|0.0289
71007526|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.276|||<|0.0001|TWO_SIDED|95.0|1.177|1.383|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.383|1.177|<0.0001
71007527|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.894||||0.0099|TWO_SIDED|95.0|0.821|0.973|||Regression, Logistic|||The statistical analysis is presented for Cumulative ribavirin dose per 10000 mg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.973|0.821|0.0099
71007528|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.945||||0.0058|TWO_SIDED|95.0|1.213|3.12|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.120|1.213|0.0058
71007529|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.262|||<|0.0001|TWO_SIDED|95.0|1.154|1.38|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.380|1.154|<0.0001
71007530|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.945||||0.0058|TWO_SIDED|95.0|1.213|3.12|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.120|1.213|0.0058
71007531|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.262|||<|0.0001|TWO_SIDED|95.0|1.154|1.38|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.380|1.154|<0.0001
71007532|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.615||||0.0205|TWO_SIDED|95.0|1.219|10.721|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (ASIAN vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||10.721|1.219|0.0205
71007533|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.981||||0.9557|TWO_SIDED|95.0|0.506|1.903|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (BLACK vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.903|0.506|0.9557
71007534|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.599||||0.2|TWO_SIDED|95.0|0.273|1.312|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (HISPANIC vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.312|0.273|0.2000
71007535|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.684||||0.0437|TWO_SIDED|95.0|1.037|13.083|||Regression, Logistic|||The statistical analysis is presented for (OTHER vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||13.083|1.037|0.0437
71007536|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|134.6|||<|0.0001|TWO_SIDED|95.0|17.956|1009.0|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (RVR vs NO RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1009.0|17.956|<0.0001
70925522|NCT05894577|141344543|OTHER||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.69|2.0|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||2.00|0.69|
71007537|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|77.905|||<|0.0001|TWO_SIDED|95.0|10.521|576.85|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (cEVR vs NO RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||576.85|10.521|<0.0001
71007538|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.527||||0.0105|TWO_SIDED|95.0|1.872|112.73|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (pEVR vs NO RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||112.73|1.872|0.0105
71007539|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.563||||0.0041|TWO_SIDED|95.0|1.152|2.12|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.120|1.152|0.0041
71007540|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.557|||<|0.0001|TWO_SIDED|95.0|2.405|12.838|||Regression, Logistic|||The statistical analysis is presented for On-treatment response, combined (RVR vs NO RVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||12.838|2.405|<0.0001
71007541|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.822||||0.0037|TWO_SIDED|95.0|1.216|2.732|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.732|1.216|0.0037
71007542|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.342|||<|0.0001|TWO_SIDED|95.0|3.977|32.347|||Regression, Logistic|||The statistical analysis is presented for On-treatment response, combined (RVR vs NO RVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||32.347|3.977|<0.0001
71007543|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.112|||<|0.0001|TWO_SIDED|95.0|1.068|1.158|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||1.158|1.068|<0.0001
71045261|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|1.54||||0.0152|TWO_SIDED|95.0|1.09|2.18|||Regression, Logistic|||Week 24, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.18|1.09|0.0152
71045262|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|1.73||||0.0018|TWO_SIDED|95.0|1.23|2.45|||Regression, Logistic|||Week 24, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.45|1.23|0.0018
71102252|NCT01251757|141712461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.019|TWO_SIDED|95.0|-2.7|-0.2||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Linear|adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline LDL group.|MeanLDL levels were sig lower for IVR+ participants than for UC participants. In subgroup analyses this difference was most pronounced in those individuals with baseline LDL levels above 100 mg/dL (adj diff=-3.6 mg/dL, 95%CI= (-5.9, -1.3), p=.002).|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline LDL level subgroups.||-0.2|-2.7|.019
71007544|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.112|||<|0.0001|TWO_SIDED|95.0|1.068|1.158|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||1.158|1.068|<0.0001
71045263|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|1.47||||0.097|TWO_SIDED|95.0|0.93|2.31|||Regression, Logistic|||Week 24, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.31|0.93|0.0970
71045264|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|1.25||||0.3435|TWO_SIDED|95.0|0.79|1.98|||Regression, Logistic|||Week 24, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.98|0.79|0.3435
71102253|NCT01251757|141712462|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.59|TWO_SIDED|95.0|0.93|1.13||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Logistic|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline LDL group.||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline LDL level subgroups.||1.13|0.93|.59
71102254|NCT01251757|141712462|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.058|TWO_SIDED|95.0|1.0|1.22||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Logistic|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline LDL group.|Though higher for the IVR+ group, LDL control did not differ significantly between the IVR+ and UC arms. Among those with poor initial control, however, control was sig better for the IVR+ arm (OR = 1.21, 95%CI = (1.04, 1.42), p=.015).|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline LDL level subgroups.||1.22|1.00|.058
71102255|NCT02796651|141712463|SUPERIORITY||LSMean difference|0.108|||<|0.001|TWO_SIDED|95.0|0.055|0.161|||Mixed Models Analysis|||||0.161|0.055|<0.001
71007545|NCT01066819|141523460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.921||||0.0035|TWO_SIDED|95.0|1.686|14.362|||Regression, Logistic|||The statistical analysis is presented for On-treatment response, combined (RVR vs NO RVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||14.362|1.686|0.0035
71007546|NCT01066819|141523477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.441||||0.0162|TWO_SIDED|95.0|0.226|0.859|||Regression, Logistic|||The statistical analysis is presented for Sex (MALE vs FEMALE). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.859|0.226|0.0162
71007547|NCT01066819|141523477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.745||||0.0156|TWO_SIDED|95.0|1.111|2.741|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.741|1.111|0.0156
71102256|NCT02796651|141712463|SUPERIORITY||LSMean difference|0.117|||<|0.001|TWO_SIDED|95.0|0.064|0.171|||Mixed Models Analysis|||||0.171|0.064|<0.001
70925523|NCT05894577|141344544|OTHER||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.66|1.15|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.15|0.66|
70925524|NCT05894577|141344544|OTHER||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.63|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.14|0.63|
70925525|NCT05894577|141344544|OTHER||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.56|1.08|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.08|0.56|
70925526|NCT05894577|141344544|OTHER||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.73|1.45|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.45|0.73|
70925527|NCT05894577|141344544|OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.71|1.4|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.40|0.71|
70925528|NCT05894577|141344544|OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.6|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||1.35|0.60|
70925529|NCT05894577|141344545|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.7|1.31|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.31|0.70|
70925530|NCT05894577|141344545|OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.72|1.4|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.40|0.72|
70925531|NCT05894577|141344545|OTHER||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.55|1.2|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.20|0.55|
70925532|NCT05894577|141344545|OTHER||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.62|1.39|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.39|0.62|
70925533|NCT05894577|141344545|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.65|1.46|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.46|0.65|
70925534|NCT05894577|141344545|OTHER||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.48|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||1.35|0.48|
70925535|NCT05894577|141344546|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.62|1.24|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.24|0.62|
70925536|NCT05894577|141344546|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.65|1.38|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.38|0.65|
70925537|NCT05894577|141344546|OTHER||Odds Ratio (OR)|0.74|||||TWO_SIDED|95.0|0.49|1.13|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.13|0.49|
71102257|NCT02796651|141712463|SUPERIORITY||LSMean difference|0.162|||<|0.001|TWO_SIDED|95.0|0.107|0.216|||Mixed Models Analysis|||||0.216|0.107|<0.001
71102258|NCT02796651|141712463|SUPERIORITY||LSMean difference|0.122|||<|0.001|TWO_SIDED|95.0|0.069|0.175|||Mixed Models Analysis|||||0.175|0.069|<0.001
71102259|NCT02796651|141712463|SUPERIORITY||LSMean difference|0.009||||0.556|TWO_SIDED|95.0|-0.021|0.039|||Mixed Models Analysis|||||0.039|-0.021|0.556
71102260|NCT02796651|141712463|SUPERIORITY||LSMean difference|0.053||||0.001|TWO_SIDED|95.0|0.021|0.085|||Mixed Models Analysis|||||0.085|0.021|0.001
71102261|NCT02796651|141712463|SUPERIORITY||LSMean difference|0.014||||0.365|TWO_SIDED|95.0|-0.016|0.044|||Mixed Models Analysis|||||0.044|-0.016|0.365
71102262|NCT02796651|141712463|SUPERIORITY||LSMean difference|0.044||||0.006|TWO_SIDED|95.0|0.013|0.076|||Mixed Models Analysis|||||0.076|0.013|0.006
71102263|NCT02796651|141712463|SUPERIORITY||LSMean difference|0.005||||0.756|TWO_SIDED|95.0|-0.026|0.036|||Mixed Models Analysis|||||0.036|-0.026|0.756
71102264|NCT02796651|141712463|SUPERIORITY||LSMean difference|-0.039||||0.014|TWO_SIDED|95.0|-0.071|-0.008|||Mixed Models Analysis|||||-0.008|-0.071|0.014
71102265|NCT02796651|141712464|SUPERIORITY||LSMean difference|0.13|||<|0.001|TWO_SIDED|95.0|0.091|0.169|||Mixed Models Analysis|||||0.169|0.091|<0.001
71102266|NCT02796651|141712464|SUPERIORITY||LSMean difference|0.167|||<|0.001|TWO_SIDED|95.0|0.128|0.206|||Mixed Models Analysis|||||0.206|0.128|<0.001
71102267|NCT02796651|141712464|SUPERIORITY||LSMean difference|0.224|||<|0.001|TWO_SIDED|95.0|0.184|0.263|||Mixed Models Analysis|||||0.263|0.184|<0.001
71102268|NCT02796651|141712464|SUPERIORITY||LSMean difference|0.214|||<|0.001|TWO_SIDED|95.0|0.176|0.253|||Mixed Models Analysis|||||0.253|0.176|<0.001
71102269|NCT02796651|141712464|SUPERIORITY||LSMean difference|0.265|||<|0.001|TWO_SIDED|95.0|0.226|0.304|||Mixed Models Analysis|||||0.304|0.226|<0.001
70925538|NCT05894577|141344546|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.67|1.55|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.55|0.67|
70925539|NCT05894577|141344546|OTHER||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.51|1.19|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.19|0.51|
70925540|NCT05894577|141344546|OTHER||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.49|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||1.35|0.49|
71007548|NCT01066819|141523477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.372||||0.1075|TWO_SIDED|95.0|0.829|6.789|||Regression, Logistic|||The statistical analysis is presented for Alanine Aminotransferase (ALT) ratio at BL (\<=1 vs \> 3). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.789|0.829|0.1075
71007549|NCT01066819|141523477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.906||||0.8518|TWO_SIDED|95.0|0.321|2.559|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\> 1 - 3 vs \> 3). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.559|0.321|0.8518
71007550|NCT01066819|141523477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.969||||0.0012|TWO_SIDED|95.0|0.951|0.988|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.988|0.951|0.0012
71007551|NCT01066819|141523477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.441||||0.0162|TWO_SIDED|95.0|0.226|0.859|||Regression, Logistic|||The statistical analysis is presented for Sex (MALE vs FEMALE). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.859|0.226|0.0162
71007552|NCT01066819|141523477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.745||||0.0156|TWO_SIDED|95.0|1.111|2.741|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.741|1.111|0.0156
71007553|NCT01066819|141523477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.372||||0.1075|TWO_SIDED|95.0|0.829|6.789|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\<=1 vs \> 3). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.789|0.829|0.1075
71007554|NCT01066819|141523477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.906||||0.8518|TWO_SIDED|95.0|0.321|2.559|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\> 1 - 3 vs \> 3). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.559|0.321|0.8518
71007555|NCT01066819|141523477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.969||||0.0012|TWO_SIDED|95.0|0.951|0.988|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.988|0.951|0.0012
71102270|NCT02796651|141712464|SUPERIORITY||LSMean difference|0.037||||0.004|TWO_SIDED|95.0|0.012|0.062|||Mixed Models Analysis|||||0.062|0.012|0.004
70925541|NCT05894577|141344547|OTHER||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.77|1.41|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.41|0.77|
71102271|NCT02796651|141712464|SUPERIORITY||LSMean difference|0.094|||<|0.001|TWO_SIDED|95.0|0.068|0.119|||Mixed Models Analysis|||||0.119|0.068|<0.001
71102272|NCT02796651|141712464|SUPERIORITY||LSMean difference|0.084|||<|0.001|TWO_SIDED|95.0|0.059|0.11|||Mixed Models Analysis|||||0.110|0.059|<0.001
71102273|NCT02796651|141712464|SUPERIORITY||LSMean difference|0.135|||<|0.001|TWO_SIDED|95.0|0.109|0.161|||Mixed Models Analysis|||||0.161|0.109|<0.001
70925542|NCT05894577|141344547|OTHER||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.82|1.69|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.69|0.82|
70925543|NCT05894577|141344547|OTHER||Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.52|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.14|0.52|
70925544|NCT05894577|141344547|OTHER||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.65|1.43|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.43|0.65|
71007556|NCT01066819|141523477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.848||||0.0017|TWO_SIDED|95.0|0.765|0.94|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.940|0.765|0.0017
71007557|NCT01066819|141523477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.848||||0.0017|TWO_SIDED|95.0|0.765|0.94|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.940|0.765|0.0017
71007558|NCT01066819|141523477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.401||||0.0071|TWO_SIDED|95.0|0.206|0.78|||Regression, Logistic|||The statistical analysis is presented for Sex (MALE vs FEMALE). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.780|0.206|0.0071
71007559|NCT01066819|141523477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.016||||0.0006|TWO_SIDED|95.0|0.001|0.169|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (RVR vs NO RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.169|0.001|0.0006
71007560|NCT01066819|141523477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.076||||0.0255|TWO_SIDED|95.0|0.008|0.729|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (cEVR vs NO RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.729|0.008|0.0255
71007561|NCT01066819|141523477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.184||||0.1501|TWO_SIDED|95.0|0.018|1.845|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (pEVR vs NO RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.845|0.018|0.1501
71007562|NCT01066819|141523477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|27.25|||<|0.0001|TWO_SIDED|95.0|6.729|110.35|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (cEVR vs RVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||110.35|6.729|<0.0001
71007563|NCT00805194|141523480|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0019|TWO_SIDED|95.0|0.68|0.92|||Regression, Cox||Hazard Ratio (HR) below 1 favors nintedanib|HR, Confidence Interval (CI) and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)||0.92|0.68|0.0019
71007564|NCT00805194|141523481|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.0073|TWO_SIDED|95.0|0.6|0.92||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs 1 - one pat. had 2), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||"The overall alpha level followed a Lan-DeMets spending function with O'Brien-Fleming shape parameter to preserve an overall 2-sided alpha level of 0.05.~HR below 1 favors nintedanib"|"Hierarchical testing was tested in a fixed sequence of statistical hypotheses in (1) patients with adenocarcinoma and \<9 months since start of first-line therapy, (2) patients with adenocarcinoma, and (3) all patients. Each hypothesis could be only tested at the pre-specified alpha level if the previous null hypothesis in the testing sequence had been rejected.~Overall survival for patients with adenocarcinoma and \<9 months since start of first line therapy."||0.92|0.60|0.0073
71007565|NCT00805194|141523481|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0359|TWO_SIDED|95.0|0.7|0.99||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs 1 - one pat. had 2), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||"The overall alpha level followed a Lan-DeMets spending function with O'Brien-Fleming shape parameter to preserve an overall 2-sided alpha level of 0.05.~HR below 1 favors nintedanib"|"Hierarchical testing was tested in a fixed sequence of statistical hypotheses in (1) patients with adenocarcinoma and \<9 months since start of first-line therapy, (2) patients with adenocarcinoma, and (3) all patients. Each hypothesis could be only tested at the pre-specified alpha level if the previous null hypothesis in the testing sequence had been rejected.~Overall survival for patients with adenocarcinoma."||0.99|0.70|0.0359
71102274|NCT02796651|141712464|SUPERIORITY||LSMean difference|0.057|||<|0.001|TWO_SIDED|95.0|0.031|0.082|||Mixed Models Analysis|||||0.082|0.031|<0.001
71102275|NCT02796651|141712464|SUPERIORITY||LSMean difference|0.047|||<|0.001|TWO_SIDED|95.0|0.023|0.071|||Mixed Models Analysis|||||0.071|0.023|<0.001
71102276|NCT02796651|141712464|SUPERIORITY||LSMean difference|0.098|||<|0.001|TWO_SIDED|95.0|0.073|0.123|||Mixed Models Analysis|||||0.123|0.073|<0.001
71102277|NCT02796651|141712464|SUPERIORITY||LSMean difference|-0.009||||0.469|TWO_SIDED|95.0|-0.035|0.016|||Mixed Models Analysis|||||0.016|-0.035|0.469
71102278|NCT02796651|141712464|SUPERIORITY||LSMean difference|0.041||||0.002|TWO_SIDED|95.0|0.015|0.068|||Mixed Models Analysis|||||0.068|0.015|0.002
71102279|NCT02796651|141712464|SUPERIORITY||LSMean difference|0.051|||<|0.001|TWO_SIDED|95.0|0.025|0.076|||Mixed Models Analysis|||||0.076|0.025|<0.001
71102280|NCT02796651|141712465|SUPERIORITY||LSMean difference|0.159|||<|0.001|TWO_SIDED|95.0|0.105|0.213|||Mixed Models Analysis|||||0.213|0.105|<0.001
71102281|NCT02796651|141712465|SUPERIORITY||LSMean difference|0.17|||<|0.001|TWO_SIDED|95.0|0.116|0.224|||Mixed Models Analysis|||||0.224|0.116|<0.001
71007566|NCT00805194|141523481|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.272|TWO_SIDED|95.0|0.83|1.05||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs 1 - one pat. had 2), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||The overall alpha level followed a Lan-DeMets spending function with O'Brien-Fleming shape parameter to preserve an overall 2-sided alpha level of 0.05. HR below 1 favors nintedanib|"Hierarchical testing was tested in a fixed sequence of statistical hypotheses in (1) patients with adenocarcinoma and \<9 months since start of first-line therapy, (2) patients with adenocarcinoma, and (3) all patients. Each hypothesis could be only tested at the pre-specified alpha level if the previous null hypothesis in the testing sequence had been rejected.~Overall survival for all patients."||1.05|0.83|0.2720
71102282|NCT02796651|141712465|SUPERIORITY||LSMean difference|0.219|||<|0.001|TWO_SIDED|95.0|0.163|0.274|||Mixed Models Analysis|||||0.274|0.163|<0.001
71102283|NCT02796651|141712465|SUPERIORITY||LSMean difference|0.179|||<|0.001|TWO_SIDED|95.0|0.125|0.233|||Mixed Models Analysis|||||0.233|0.125|<0.001
71102284|NCT02796651|141712465|SUPERIORITY||LSMean difference|0.011||||0.488|TWO_SIDED|95.0|-0.02|0.042|||Mixed Models Analysis|||||0.042|-0.020|0.488
71102285|NCT02796651|141712465|SUPERIORITY||LSMean difference|0.06|||<|0.001|TWO_SIDED|95.0|0.027|0.092|||Mixed Models Analysis|||||0.092|0.027|<0.001
71102286|NCT02796651|141712465|SUPERIORITY||LSMean difference|0.02||||0.206|TWO_SIDED|95.0|-0.011|0.051|||Mixed Models Analysis|||||0.051|-0.011|0.206
71007567|NCT00805194|141523482|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.007|TWO_SIDED|95.0|0.75|0.96||HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib|||0.96|0.75|0.0070
71007568|NCT00805194|141523483|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.0012|TWO_SIDED|95.0|0.73|0.93||HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib|||0.93|0.73|0.0012
71007569|NCT00805194|141523484|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.3067|TWO_SIDED|95.0|0.76|2.39||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on the central independent review||2.39|0.76|0.3067
71007570|NCT00805194|141523484|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.0761|TWO_SIDED|95.0|0.96|2.08||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on the investigator's assessment||2.08|0.96|0.0761
71007571|NCT00805194|141523487|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68|||<|0.0001|TWO_SIDED|95.0|1.35|2.09||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on the central independent review||2.09|1.35|<0.0001
71007572|NCT00805194|141523487|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64|||<|0.0001|TWO_SIDED|95.0|1.31|2.05||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on investigator's assessment||2.05|1.31|<0.0001
71007573|NCT00805194|141523489|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|ANOVA|||Analysis based on the central independent review||||<0.0001
71007574|NCT00805194|141523489|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|ANOVA|||Analysis based on the investigator's assessment||||<0.0001
71007575|NCT00805194|141523490|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.7282|TWO_SIDED|95.0|0.87|1.21||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs 1 - one pat.had 2), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib|||1.21|0.87|0.7282
71102287|NCT02796651|141712465|SUPERIORITY||LSMean difference|0.049||||0.004|TWO_SIDED|95.0|0.016|0.081|||Mixed Models Analysis|||||0.081|0.016|0.004
71102288|NCT02796651|141712465|SUPERIORITY||LSMean difference|0.009||||0.567|TWO_SIDED|95.0|-0.022|0.041|||Mixed Models Analysis|||||0.041|-0.022|0.567
71102289|NCT02796651|141712465|SUPERIORITY||LSMean difference|-0.039||||0.017|TWO_SIDED|95.0|-0.072|-0.007|||Mixed Models Analysis|||||-0.007|-0.072|0.017
71102290|NCT02796651|141712466|SUPERIORITY||LSMean difference|0.075||||0.027|TWO_SIDED|95.0|0.008|0.141|||Mixed Models Analysis|||||0.141|0.008|0.027
71102291|NCT02796651|141712466|SUPERIORITY||LSMean difference|0.065||||0.054|TWO_SIDED|95.0|-0.001|0.131|||Mixed Models Analysis|||||0.131|-0.001|0.054
71102292|NCT02796651|141712466|SUPERIORITY||LSMean difference|0.1||||0.004|TWO_SIDED|95.0|0.032|0.168|||Mixed Models Analysis|||||0.168|0.032|0.004
71102293|NCT02796651|141712466|SUPERIORITY||LSMean difference|0.059||||0.075|TWO_SIDED|95.0|-0.006|0.123|||Mixed Models Analysis|||||0.123|-0.006|0.075
71102294|NCT02796651|141712466|SUPERIORITY||LSMean difference|-0.01||||0.615|TWO_SIDED|95.0|-0.048|0.028|||Mixed Models Analysis|||||0.028|-0.048|0.615
71102295|NCT02796651|141712466|SUPERIORITY||LSMean difference|0.025||||0.209|TWO_SIDED|95.0|-0.014|0.065|||Mixed Models Analysis|||||0.065|-0.014|0.209
71102296|NCT02796651|141712466|SUPERIORITY||LSMean difference|-0.016||||0.403|TWO_SIDED|95.0|-0.053|0.022|||Mixed Models Analysis|||||0.022|-0.053|0.403
71102297|NCT02796651|141712466|SUPERIORITY||LSMean difference|0.035||||0.074|TWO_SIDED|95.0|-0.003|0.074|||Mixed Models Analysis|||||0.074|-0.003|0.074
71102298|NCT02796651|141712466|SUPERIORITY||LSMean difference|-0.006||||0.75|TWO_SIDED|95.0|-0.045|0.032|||Mixed Models Analysis|||||0.032|-0.045|0.750
71102299|NCT02796651|141712466|SUPERIORITY||LSMean difference|-0.041||||0.035|TWO_SIDED|95.0|-0.08|-0.003|||Mixed Models Analysis|||||-0.003|-0.080|0.035
71007576|NCT00805194|141523491|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.1858|TWO_SIDED|95.0|0.77|1.05||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs \>=1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of cough||1.05|0.77|0.1858
71007577|NCT00805194|141523491|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.5203|TWO_SIDED|95.0|0.91|1.2||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs \>=1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of dyspnoea||1.20|0.91|0.5203
71007578|NCT00805194|141523491|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.4373|TWO_SIDED|95.0|0.82|1.09||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs \>= 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of pain||1.09|0.82|0.4373
71007579|NCT02275052|141523502|SUPERIORITY_OR_OTHER||Least squares mean difference|3.31||||0.79|TWO_SIDED|95.0|-21.12|27.74||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||27.74|-21.12|0.790
71007580|NCT02275052|141523503|SUPERIORITY_OR_OTHER||Least squares mean difference|0.206|||<|0.001|TWO_SIDED|95.0|0.167|0.246|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|Least squares mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||0.246|0.167|<0.001
71007581|NCT02275052|141523504|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.346|||<|0.001|TWO_SIDED|95.0|-0.487|-0.204|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|Least squares mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||-0.204|-0.487|<0.001
71045265|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|3.3||||0.0236|TWO_SIDED|95.0|1.17|9.27|||Regression, Logistic|||Week 24, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||9.27|1.17|0.0236
71102300|NCT05430919|141712468|SUPERIORITY||Least Squares (LS) Mean Difference|-2.31|||<|0.0001|TWO_SIDED|95.0|-3.229|-1.385|||ANCOVA||REGN5713-5714-5715 900 mg vs. Placebo, Day 29|||-1.385|-3.229|<0.0001
71007582|NCT02275052|141523505|SUPERIORITY_OR_OTHER||Least squares mean difference|0.259|||<|0.001|TWO_SIDED|95.0|0.194|0.324|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|Least squares mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||0.324|0.194|<0.001
71045266|NCT02709486|141599382|SUPERIORITY||Odds Ratio (OR)|3.14||||0.0296|TWO_SIDED|95.0|1.12|8.81|||Regression, Logistic|||Week 24, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||8.81|1.12|0.0296
71045267|NCT02709486|141599384|SUPERIORITY||Odds Ratio (OR)|2.14||||0.0132|TWO_SIDED|95.0|1.17|3.9|||Regression, Logistic|||Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.90|1.17|0.0132
71102301|NCT05430919|141712469|SUPERIORITY||LS Mean Difference|-2.65|||<|0.0001|TWO_SIDED|95.0|-3.634|-1.658|||ANCOVA||REGN5713-5715 600 mg vs. Placebo, Day 29|||-1.658|-3.634|<0.0001
71102302|NCT05430919|141712469|SUPERIORITY||LS Mean Difference|-1.51||||0.0023|TWO_SIDED|95.0|-2.478|-0.539|||ANCOVA||REGN5715 300 mg vs. Placebo, Day 29|||-0.539|-2.478|0.0023
71102303|NCT05430919|141712485|SUPERIORITY||LS Mean Difference|-63.18|||<|0.0001|TWO_SIDED|95.0|-73.411|-52.95|||ANCOVA||REGN5713-5714-5715 900 mg vs. Placebo, Day 29|||-52.950|-73.411|<0.0001
71102304|NCT05430919|141712485|SUPERIORITY||LS Mean Difference|-56.01|||<|0.0001|TWO_SIDED|95.0|-66.806|-45.204|||ANCOVA||REGN5713-5715 600 mg vs. Placebo, Day 29|||-45.204|-66.806|<0.0001
71102305|NCT05430919|141712485|SUPERIORITY||LS Mean Difference|-34.82|||<|0.0001|TWO_SIDED|95.0|-45.304|-24.343|||ANCOVA||REGN5715 300 mg vs. Placebo, Day 29|||-24.343|-45.304|<0.0001
71102306|NCT01469156|141712524|OTHER|Visually significant ocular or systemic AEs were predominantly mild or moderate. No significant safety signals were observed in either group.High- and standard-dose ranibizumab were generally well tolerated without evidence of ocular or systemic severe adverse events, including arterial thromboembolic events.|data survey|28.0||||0.05|TWO_SIDED|95.0|0.0|28.0||28 ocular and non-ocular adverse events collected, in mild to moderate nature|t-test, 2 sided|||Purpose was to determine safety and efficacy of intravitreal high-dose ranibizumab in the treatment of active PCV.|Visually significant ocular or systemic AEs that were either reported by subjects or identified by imaging and/or ocular exam|28|0|0.05
71102307|NCT03926247|141712611|OTHER|Within-group longitudinal analysis (no comparison groups)|LSM Final Difference|-0.044|STANDARD_ERROR_OF_MEAN|0.019|=|0.019|TWO_SIDED|95.0|-0.087|-0.008|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' depression/anxiety symptoms would decrease overtime.||-0.008|-0.087|=0.019
71102308|NCT03926247|141712612|OTHER|Within-group longitudinal analysis (no comparison groups)|Mean Difference (Final Values)|-0.892|STANDARD_ERROR_OF_MEAN|0.643|=|0.168|TWO_SIDED|95.0|-2.161|0.372|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' PTSD symptoms would decrease overtime.||0.372|-2.161|=0.168
71045268|NCT02709486|141599384|SUPERIORITY||Odds Ratio (OR)|1.62||||0.1274|TWO_SIDED|95.0|0.87|3.02|||Regression, Logistic|||Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.02|0.87|0.1274
71045269|NCT02709486|141599384|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0016|TWO_SIDED|95.0|1.44|4.76|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.76|1.44|0.0016
71102309|NCT03926247|141712613|OTHER|Within-group longitudinal analysis (no comparison groups)|Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.035|=|0.051|TWO_SIDED|95.0|-0.14|0.0|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' stress would decrease overtime.||-0.000|-0.140|=0.051
71102310|NCT03926247|141712614|OTHER|Within-group longitudinal analysis (no comparison groups)|Mean Difference (Final Values)|-0.041|STANDARD_ERROR_OF_MEAN|0.029|=|0.211|TWO_SIDED|95.0|-0.106|0.023|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' social support would increase overtime.||0.023|-0.106|=0.211
71102311|NCT03926247|141712615|OTHER|Within-group longitudinal analysis (no comparison groups)|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.053|=|0.074|TWO_SIDED|95.0|-0.008|0.201|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' access to resources would increase overtime.||0.201|-0.008|=0.074
71102312|NCT03926247|141712616|OTHER|Within-group longitudinal analysis (no comparison groups)=|Mean Difference (Final Values)|-0.119|STANDARD_ERROR_OF_MEAN|0.061|=|0.089|TWO_SIDED|95.0|-0.257|0.017|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' difficulty accessing resources would decrease overtime.||0.017|-0.257|=0.089
71102313|NCT03926247|141712617|OTHER|Within-group longitudinal analysis (no comparison groups)|Mean Difference (Final Values)|-0.216|STANDARD_ERROR_OF_MEAN|0.124|=|0.086|TWO_SIDED|95.0|-0.461|0.03|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' quality of life would increase overtime.||0.030|-0.461|=0.086
71102314|NCT00773461|141712634|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71102315|NCT00773461|141712634|SUPERIORITY_OR_OTHER||||||<|0.0001||||||ITT Population (Sensitivity)|Cochran-Mantel-Haenszel|||||||<0.0001
71102316|NCT00773461|141712635|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Comparison of ACR 50 responders in placebo and Tocilizumab groups|Cochran-Mantel-Haenszel|||||||<0.0001
71045270|NCT02709486|141599384|SUPERIORITY||Odds Ratio (OR)|3.34|||<|0.0001|TWO_SIDED|95.0|1.84|6.03|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||6.03|1.84|<.0001
71045271|NCT02709486|141599384|SUPERIORITY||Odds Ratio (OR)|2.04||||0.0089|TWO_SIDED|95.0|1.2|3.49|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.49|1.20|0.0089
71045272|NCT02709486|141599384|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0012|TWO_SIDED|95.0|1.42|4.1|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.10|1.42|0.0012
71102317|NCT00773461|141712635|SUPERIORITY_OR_OTHER|||||||0.0345||||||Comparison of ACR 70 responders in placebo and Tocilizumab groups|Cochran-Mantel-Haenszel|||||||0.0345
71102318|NCT00773461|141712637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|||<|0.0001|TWO_SIDED|95.0|-6.6|-2.8||p value was calculated using the difference between core set values of the two arms.|ANCOVA|||Placebo + DMARDs Vs Tocilizumab + DMARDs analysis for Swollen Joint Count||-2.8|-6.6|<0.0001
71102319|NCT00773461|141712637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.7|||<|0.0001|TWO_SIDED|95.0|-11.3|-6.1||p value was calculated using the difference between core set values of the two arms.|ANCOVA|||Placebo + DMARDs Vs Tocilizumab + DMARDs analysis for Tender Joint Count||-6.1|-11.3|<0.0001
71102320|NCT00773461|141712638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.1|||<|0.0001|TWO_SIDED|95.0|-25.3|-12.9|||ANCOVA|||||-12.9|-25.3|<0.0001
71102321|NCT00773461|141712639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.3|||<|0.0001|TWO_SIDED|95.0|-24.5|-14.0|||ANCOVA|||||-14.0|-24.5|<0.0001
71102322|NCT00773461|141712640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.0|||<|0.0001|TWO_SIDED|95.0|-25.2|-12.7|||ANCOVA|||||-12.7|-25.2|<0.0001
71102323|NCT00773461|141712641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7384|||<|0.0001|TWO_SIDED|95.0|-2.1464|-1.3303|||ANCOVA|||||-1.3303|-2.1464|<0.0001
70925545|NCT05894577|141344547|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.63|1.41|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.41|0.63|
70925546|NCT05894577|141344547|OTHER||Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.44|1.19|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||1.19|0.44|
70925547|NCT05894577|141344548|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.75|1.39|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.39|0.75|
71045273|NCT02709486|141599384|SUPERIORITY||Odds Ratio (OR)|2.4||||0.0006|TWO_SIDED|95.0|1.45|3.98|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.98|1.45|0.0006
71045274|NCT02709486|141599384|SUPERIORITY||Odds Ratio (OR)|3.16|||<|0.0001|TWO_SIDED|95.0|1.92|5.21|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||5.21|1.92|<.0001
71045275|NCT02709486|141599384|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0203|TWO_SIDED|95.0|1.1|3.06|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.06|1.10|0.0203
71045276|NCT02709486|141599384|SUPERIORITY||Odds Ratio (OR)|2.94|||<|0.0001|TWO_SIDED|95.0|1.77|4.86|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.86|1.77|<.0001
71045277|NCT02709486|141599384|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0775|TWO_SIDED|95.0|0.95|2.55|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.55|0.95|0.0775
71045278|NCT02709486|141599384|SUPERIORITY||Odds Ratio (OR)|1.97||||0.0064|TWO_SIDED|95.0|1.21|3.21|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.21|1.21|0.0064
71045279|NCT02709486|141599385|SUPERIORITY||Least Square Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.7|-0.27|||ANCOVA|||Week 1: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.27|-0.70|<.0001
71045280|NCT02709486|141599385|SUPERIORITY||Least Square Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.11||0.0009|TWO_SIDED|95.0|-0.58|-0.15|||ANCOVA|||Week 1: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.15|-0.58|0.0009
71045281|NCT02709486|141599385|SUPERIORITY||Least Square Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.0|-0.48|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.48|-1.00|<.0001
71102324|NCT00773461|141712642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.2|||<|0.0001|TWO_SIDED|95.0|-44.7|-33.7|||ANCOVA|||||-33.7|-44.7|<.0001
70925548|NCT05894577|141344548|OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.76|1.44|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.44|0.76|
70925549|NCT05894577|141344548|OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.84|1.71|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.71|0.84|
71045282|NCT02709486|141599385|SUPERIORITY||Least Square Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.13||0.0001|TWO_SIDED|95.0|-0.77|-0.25|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.25|-0.77|0.0001
71102325|NCT00773461|141712644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8||||0.0003|TWO_SIDED|95.0|1.8|5.9|||ANCOVA|||||5.9|1.8|0.0003
71102326|NCT00773461|141712645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-68.3||||0.0599|TWO_SIDED|95.0|-139.5|2.9|||ANCOVA|||||2.9|-139.5|0.0599
71102327|NCT00773461|141712646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.956|||<|0.0001|TWO_SIDED|95.0|9.125|16.786|||ANCOVA|||||16.786|9.125|<0.0001
70925550|NCT05894577|141344548|OTHER||Odds Ratio (OR)|1.14|||||TWO_SIDED|95.0|0.76|1.71|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.71|0.76|
71007583|NCT00808028|141523509|SUPERIORITY_OR_OTHER||||||>|0.9999|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||>0.9999
71007584|NCT00808028|141523509|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||0.0007
71007585|NCT00808028|141523509|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||<0.0001
71007586|NCT00808028|141523509|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||<0.0001
71045283|NCT02709486|141599385|SUPERIORITY||Least Square Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.06|-0.5|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.50|-1.06|<.0001
71045284|NCT02709486|141599385|SUPERIORITY||Least Square Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.14||0.0006|TWO_SIDED|95.0|-0.77|-0.21|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.21|-0.77|0.0006
71045285|NCT02709486|141599385|SUPERIORITY||Least Square Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.2|-0.62|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.62|-1.20|<.0001
71045286|NCT02709486|141599385|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.06|-0.47|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.47|-1.06|<.0001
71045287|NCT02709486|141599385|SUPERIORITY||Least Square Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.2|-0.59|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.59|-1.20|<.0001
70925551|NCT05894577|141344548|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.67|1.46|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.46|0.67|
71007587|NCT00808028|141523509|SUPERIORITY_OR_OTHER||||||>|0.9999|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||>0.9999
71102328|NCT00773461|141712647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.28|||ANCOVA|||||-0.28|-0.56|<0.0001
71007588|NCT00808028|141523509|SUPERIORITY_OR_OTHER|||||||0.0392|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||0.0392
71007589|NCT00808028|141523509|SUPERIORITY_OR_OTHER|||||||0.0225|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||0.0225
71007590|NCT00808028|141523509|SUPERIORITY_OR_OTHER|||||||0.0244|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||0.0244
71007591|NCT00808028|141523510|SUPERIORITY_OR_OTHER||||||>|0.9999|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||>0.9999
71007592|NCT00808028|141523510|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||0.0004
71007593|NCT00808028|141523510|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||<0.0001
71007594|NCT00808028|141523510|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||<0.0001
71007595|NCT00808028|141523510|SUPERIORITY_OR_OTHER||||||>|0.9999|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||>0.9999
71007596|NCT00808028|141523510|SUPERIORITY_OR_OTHER|||||||0.0036|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||0.0036
71045288|NCT02709486|141599385|SUPERIORITY||Least Square Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.25|-0.64|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.64|-1.25|<.0001
71045289|NCT02709486|141599385|SUPERIORITY||Least Square Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.16||0.0001|TWO_SIDED|95.0|-0.93|-0.3|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.30|-0.93|0.0001
71045290|NCT02709486|141599385|SUPERIORITY||Least Square Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.13|-0.5|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.50|-1.13|<.0001
71045291|NCT02709486|141599385|SUPERIORITY||Least Square Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.05|-0.39|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.39|-1.05|<.0001
71045292|NCT02709486|141599385|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.1|-0.44|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.44|-1.10|<.0001
71102329|NCT00322218|141712656|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8578|||||||Stratified Log-Rank Test|||||||0.8578
71102330|NCT05472870|141712658|SUPERIORITY|One-way ANOVA with repeated measures was used to examine differences in the effects of cTMS on the SRS. A P value \<0.05 was considered statistically significant for all analyses.|||||<|0.001||||||Bonferroni correction was used to adjust P values in post hoc analyses.|ANOVA|||All clinical behavioral data analysis was performed using Statistical Product and Service Solutions (SPSS) software (version 25.0). A P value \<0.05 was considered statistically significant for all analyses. One-way ANOVA with repeated measures was used to examine differences in the effects of cTMS on the SRS.||||<0.001
70925552|NCT05894577|141344548|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.62|1.59|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||1.59|0.62|
71007597|NCT00808028|141523510|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||<0.0001
71007598|NCT00808028|141523510|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||<0.0001
71007599|NCT00721136|141523569|OTHER|||||||||||||||||Continuous variables were expressed as mean ± standard deviation and analyzed using Student's t-test and Mann-Whitney U-test in cases of nonparametric distribution. Categorical variables were expressed as numbers or percentages and analyzed with two-tailed Fisher's exact test or χ2-test as appropriate. Data were analyzed on an intention-to-treat basis using STATA 10.1 (College Station, TX). A two-tailed alpha of 0.05 was considered statistically significant.|Continuous variables were expressed as mean ± standard deviation and analyzed using Student's t-test and Mann-Whitney U-test in cases of nonparametric distribution. Categorical variables were expressed as numbers or percentages and analyzed with two-tailed Fisher's exact test or χ2-test as appropriate. Data were analyzed on an intention-to-treat basis using STATA 10.1 (College Station, TX). A two-tailed alpha of 0.05 was considered statistically significant.|||
71007600|NCT00732199|141523572|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||T- test was conducted to compare the 2 groups.||||<0.05
71007601|NCT00732199|141523573|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|Compares control vs hypoxia trials vs recovery post-hypoxia||||||<0.05
71007602|NCT00732199|141523574|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71007603|NCT00732199|141523575|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71007604|NCT01051856|141523638|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35|TWO_SIDED||||||Chi-squared|||||||0.35
71007605|NCT00147082|141523640|SUPERIORITY|||||||0.05||||||The threshold for significance was p\<0.05|Kruskal-Wallis|||p values were calculated||||0.05
71007606|NCT00147082|141523641|SUPERIORITY|||||||0.05||||||The p value (\<0.05) was the threshold for significance|Kruskal-Wallis|||p value was calculated||||0.05
71007607|NCT00147082|141523642|SUPERIORITY|||||||0.05||||||The p value (\<0.05) was the threshold for significance|Kruskal-Wallis|||The p value was calculated||||0.05
71045293|NCT02709486|141599385|SUPERIORITY||Least Square Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.06|-0.39|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.39|-1.06|<.0001
71045294|NCT02709486|141599385|SUPERIORITY||Least Square Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.13|-0.46|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.46|-1.13|<.0001
71045295|NCT02709486|141599385|SUPERIORITY||Least Square Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.18||0.004|TWO_SIDED|95.0|-0.87|-0.16|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.16|-0.87|0.0040
71007608|NCT01412333|141523647|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|0.532|||<|0.0001|TWO_SIDED|95.0|0.397|0.714|||Negative Binomial Model||Rate ratio was calculated as Ocrelizumab ARR/Interferon beta-1a 44 mcg SC ARR.|Adjusted by Geographical Region (US vs. Rest of World) and baseline EDSS (\<4.0 vs. \>=4.0).||0.714|0.397|< 0.0001
71007609|NCT01412333|141523648|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||=|0.0169|TWO_SIDED|95.0|0.42|0.92|||Log Rank|||Time to onset of CDP at week 12||0.92|0.42|= 0.0169
71007610|NCT01412333|141523649|SUPERIORITY_OR_OTHER_LEGACY||Adjusted rate ratio|0.051|||<|0.0001||95.0|0.029|0.089|||Negative Binomial Model||Adjusted by baseline T1 Gd lesion (present or not), baseline EDSS (\<4.0 vs. \>=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.|||0.089|0.029|< 0.0001
71007611|NCT01412333|141523650|SUPERIORITY_OR_OTHER_LEGACY||Adjusted rate ratio|0.171|||<|0.0001||95.0|0.13|0.225|||Negative Binomial Model||Adjusted by baseline T2 lesion count, baseline EDSS (\<4.0 vs. \>=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.|||0.225|0.130|< 0.0001
71007612|NCT01412333|141523651|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (stratified)|1.14|||=|0.4019|TWO_SIDED|95.0|0.84|1.56|||CMH Chi-Squared test (stratified)|Stratified by Geographical Region (US vs. Rest of World) and baseline EDSS (\<4.0 vs. \>=4.0).||||1.56|0.84|= 0.4019
71007613|NCT01412333|141523652|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||=|0.037|TWO_SIDED|95.0|0.4|0.98|||Log Rank|||Time to onset of CDP at week 24||0.98|0.40|= 0.037
71007614|NCT01412333|141523653|SUPERIORITY_OR_OTHER_LEGACY||Adjusted rate ratio|0.357|||<|0.0001||95.0|0.272|0.47|||Negative Binomial Model||Adjusted by baseline T1-hypointense lesion count, baseline EDSS (\<4.0 vs. \>=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.|||0.47|0.272|< 0.0001
71007615|NCT01412333|141523654|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|0.107|STANDARD_ERROR_OF_MEAN|0.037|=|0.004|TWO_SIDED|95.0|0.034|0.18|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix.|Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.|||0.180|0.034|= 0.004
71102331|NCT01385995|141712668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.57|TWO_SIDED|95.0|0.52|3.24|||Generalized Estimating Equation|Controlled for period and baseline 2 hour OGTT glucose level.||Based on an intent to treat approach a Generalized Estimating Equation (GEE) was used to estimate the effect of therapy (CPAP or Sham) on the odds of normalization of Impaired Glucose Tolerance (IGT). This model provides an estimate of the odds ratio of normalizing the 2-hour oral glucose tolerance test (OGTT) with CPAP compared with Sham-CPAP.||3.24|0.52|0.57
71102332|NCT01385995|141712669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.38|TWO_SIDED|95.0|-1.2|3.0|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, Apnea-Hypopnea Index (AHI), gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of glucose indices, in this case fasting glucose, between CPAP and sham-CPAP.||3.0|-1.2|0.38
71102333|NCT01385995|141712669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.3||||0.11|TWO_SIDED|95.0|-16.3|1.7|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between measures of glucose indices, in this case, 2 hour OGTT, and therapeutic CPAP vs. Sham.||1.7|-16.3|0.11
71102334|NCT01385995|141712669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.86|TWO_SIDED|95.0|-3.3|2.7|||Regression, Linear|||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of glucose indices, in this case fasting glucose, between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) \>=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=25.||2.7|-3.3|0.86
71102335|NCT01385995|141712669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6||||0.08|TWO_SIDED|95.0|-24.6|1.3|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of glucose indices, in this case 2-hour oral glucose tolerance test (OGTT) glucose, between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) \>=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N= 25.||1.3|-24.6|0.08
71102336|NCT01385995|141712670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.14|TWO_SIDED|95.0|-3.4|0.5|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, Apnea-Hypopnea Index (AHI), gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of insulin indices, in this case, fasting insulin, between CPAP and sham-CPAP.||0.5|-3.4|0.14
71102337|NCT01385995|141712670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.7||||0.12|TWO_SIDED|95.0|-23.3|2.8|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, Apnea-Hypopnea Index (AHI), gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of insulin indices, in this case, 2-hour oral glucose tolerance test (OGTT) insulin, between CPAP and sham-CPAP.||2.8|-23.3|0.12
71102338|NCT01385995|141712670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.1|TWO_SIDED|95.0|-5.2|0.5|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of insulin indices, in this case fasting insulin, between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) \>=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=23.||0.5|-5.2|0.10
71007616|NCT01412333|141523655|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|0.112|STANDARD_ERROR_OF_MEAN|0.066|=|0.09|TWO_SIDED|95.0|-0.018|0.241|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix.|Difference in the rate of brain volume loss: 14.9%. Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.|||0.241|-0.018|= 0.09
71007617|NCT01412333|141523656|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|1.159|STANDARD_ERROR_OF_MEAN|0.564|=|0.0404|TWO_SIDED|95.0|0.051|2.268|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures using unstructured covariance matrix.|Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.|||2.268|0.051|= 0.0404
71007618|NCT01412333|141523657|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (stratified)|1.81|||<|0.0001|TWO_SIDED|95.0|1.41|2.32|||CMH Chi-Squared test (stratified)|Analyzed using CMH test, stratified by Geographical Region (US vs. rest-of-world) and baseline EDSS (\<4.0 vs. \>=4.0).||||2.32|1.41|< 0.0001
71007619|NCT00750867|141523662|SUPERIORITY_OR_OTHER|||||||0.0128||||||The P-Value was obtained by comparing the UMSARS-I scores at final visit and at baseline.|ANOVA|||||||0.0128
71007620|NCT00750867|141523662|SUPERIORITY_OR_OTHER|||||||0.025||||||The P-Value was obtained by comparing the UMSARS-II scores at final visit and at baseline.|ANOVA|||||||0.025
71007621|NCT03062605|141523717|OTHER|Inequality test||||||0.35||||||Significant at p \< 0.05|McNemar|||Strep Mutans, Baseline-12 Weeks||||0.35
71007622|NCT03062605|141523717|OTHER|Inequality test||||||0.29||||||Significant at p\<0.05|McNemar|||Strep Mutans, Baseline-12 Weeks||||0.29
71007623|NCT03062605|141523717|OTHER|Inequality test||||||0.09||||||Significant at p \< 0.05|McNemar|||Lactobacillus, Baseline-12 Weeks||||0.09
71007624|NCT03062605|141523717|OTHER|Inequality test||||||0.13||||||Significant at p \< 0.05|McNemar|||Lactobacillus, Baseline-12 Weeks||||0.13
71007625|NCT01948791|141523718|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 95% confidence interval of the mean difference between the baseline score and post-baseline score falls on the left of MeanP-MeanB+1.40, the post-baseline noninferiority to baseline can be concluded. If the upper limit of the 95% confidence interval of the mean difference between the baseline score and post-baseline score falls on the left of 0, superiority can be concluded.|||||<|0.001|||||||t-test, 1 sided|||The hypothesis to test the non-inferiority of post-baseline change in ADAS-Cog from baseline was: H0: μP - μB ≥ 1.40, Ha: μP - μB \< 1.40 where μP and μB are the ADAS-Cog score (actual) at 16 weeks of Rivastigmine treatment and the baseline ADAS-Cog score (actual), respectively.||||<0.001
71007626|NCT03481634|141523723|NON_INFERIORITY|Non-inferiority (4-letter margin)|LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.81|<|0.001|TWO_SIDED|95.0|-2.9|0.3||1-sided p-value|ANOVA|||||0.3|-2.9|<0.001
71007627|NCT03481634|141523723|NON_INFERIORITY|Non-inferiority (4-letter margin)|LS mean difference|-3.3|STANDARD_ERROR_OF_MEAN|0.94||0.227|TWO_SIDED|95.0|-5.1|-1.4||1-sided p-value|ANOVA|||||-1.4|-5.1|0.227
71007628|NCT03481634|141523724|NON_INFERIORITY|Non-inferiority (4-letter margin)|Mean Difference (Net)|-1.5|STANDARD_ERROR_OF_MEAN|0.75|<|0.001|TWO_SIDED|95.0|-3.0|0.0||(1-sided)|ANOVA|||||-0.0|-3.0|<0.001
71007629|NCT03481634|141523724|NON_INFERIORITY|Non-inferiority (4-letter margin)|Mean Difference (Net)|-3.5|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-5.2|-1.7||(1-sided)|ANOVA|||||-1.7|-5.2|
71007630|NCT03481634|141523728|OTHER|Descriptive|LS mean difference|-3.8|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|95.0|-6.0|-1.7|||ANOVA|||||-1.7|-6.0|
71007631|NCT03481634|141523728|OTHER|Descriptive|LS mean difference|-2.0|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-4.0|0.1|||ANOVA|||||0.1|-4.0|
71007632|NCT03481634|141523731|OTHER|Descriptive|LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|8.68|||TWO_SIDED|95.0|-17.7|16.4|||ANOVA|||Week 4||16.4|-17.7|
71102339|NCT01385995|141712670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.7||||0.002|TWO_SIDED|95.0|-46.5|-10.9|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of insulin indices, in this case oral glucose tolerance test (OGTT) insulin, between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) \>=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=23.||-10.9|-46.5|0.002
71007633|NCT03481634|141523731|OTHER|Descriptive|LS mean difference|-2.1|STANDARD_ERROR_OF_MEAN|8.41|||TWO_SIDED|95.0|-18.7|14.4|||ANOVA|||Week 4||14.4|-18.7|
71007634|NCT03481634|141523731|OTHER|Descriptive|LS mean difference|12.2|STANDARD_ERROR_OF_MEAN|8.87|||TWO_SIDED|95.0|-5.2|29.7|||ANOVA|||Week 6||29.7|-5.2|
71007635|NCT03481634|141523731|OTHER|Descriptive|LS mean difference|2.4|STANDARD_ERROR_OF_MEAN|8.38|||TWO_SIDED|95.0|-14.0|18.9|||ANOVA|||Week 6||18.9|-14.0|
71007636|NCT03481634|141523731|OTHER|Descriptive|LS mean difference|1.0|STANDARD_ERROR_OF_MEAN|8.61|||TWO_SIDED|95.0|-16.0|17.9|||ANOVA|||Week 8||17.9|-16.0|
71007637|NCT03481634|141523731|OTHER|Descriptive|LS mean difference|-3.4|STANDARD_ERROR_OF_MEAN|8.28|||TWO_SIDED|95.0|-19.6|12.9|||ANOVA|||Week 8||12.9|-19.6|
71007638|NCT03481634|141523731|OTHER|Descriptive|LS mean difference|6.4|STANDARD_ERROR_OF_MEAN|8.73|||TWO_SIDED|95.0|-10.7|23.6|||ANOVA|||Week 12||23.6|-10.7|
71007639|NCT03481634|141523731|OTHER|Descriptive|LS mean difference|2.8|STANDARD_ERROR_OF_MEAN|8.85|||TWO_SIDED|95.0|-14.6|20.2|||ANOVA|||Week 12||20.2|-14.6|
71007640|NCT03481634|141523731|OTHER|Descriptive|LS mean difference|1.0|STANDARD_ERROR_OF_MEAN|8.5|||TWO_SIDED|95.0|-15.7|17.8|||ANOVA|||Week 16||17.8|-15.7|
71007641|NCT03481634|141523731|OTHER|Descriptive|LS mean difference|-3.4|STANDARD_ERROR_OF_MEAN|8.29|||TWO_SIDED|95.0|-19.7|12.9|||ANOVA|||Week 16||12.9|-19.7|
71007642|NCT03481634|141523731|OTHER|Descriptive|LS mean difference|8.9|STANDARD_ERROR_OF_MEAN|8.92|||TWO_SIDED|95.0|-8.6|26.5|||ANOVA|||Week 18||26.5|-8.6|
71007643|NCT03481634|141523731|OTHER|Descriptive|LS mean difference|2.6|STANDARD_ERROR_OF_MEAN|8.47|||TWO_SIDED|95.0|-14.1|19.2|||ANOVA|||Week 18||19.2|-14.1|
71007644|NCT03481634|141523731|OTHER|Descriptive|LS mean difference|-3.4|STANDARD_ERROR_OF_MEAN|8.55|||TWO_SIDED|95.0|-20.2|13.4|||ANOVA|||Week 20||13.4|-20.2|
71007645|NCT03481634|141523731|OTHER|Descriptive|LS mean difference|-5.8|STANDARD_ERROR_OF_MEAN|8.12|||TWO_SIDED|95.0|-21.7|10.2|||ANOVA|||Week 20||10.2|-21.7|
71007646|NCT03481634|141523731|OTHER|Descriptive|LS mean difference|-13.9|STANDARD_ERROR_OF_MEAN|9.06|||TWO_SIDED|95.0|-31.7|3.9|||ANOVA|||Week 24||3.9|-31.7|
71007647|NCT03481634|141523731|OTHER|Descriptive|LS mean difference|-17.8|STANDARD_ERROR_OF_MEAN|8.95|||TWO_SIDED|95.0|-35.4|-0.2|||ANOVA|||Week 24||-0.2|-35.4|
71007648|NCT03481634|141523731|OTHER|Descriptive|LS mean difference|-8.7|STANDARD_ERROR_OF_MEAN|8.26|||TWO_SIDED|95.0|-25.0|7.5|||ANOVA|||Week 28||7.5|-25.0|
71007649|NCT03481634|141523731|OTHER|Descriptive|LS mean difference|-8.7|STANDARD_ERROR_OF_MEAN|8.49|||TWO_SIDED|95.0|-25.4|8.0|||ANOVA|||Week 28||8.0|-25.4|
71007650|NCT03481634|141523731|OTHER|Descriptive|LS mean difference|-3.2|STANDARD_ERROR_OF_MEAN|9.49|||TWO_SIDED|95.0|-21.8|15.5|||ANOVA|||Week 32||15.5|-21.8|
71007651|NCT03481634|141523731|OTHER|Descriptive|LS mean difference|-11.7|STANDARD_ERROR_OF_MEAN|9.02|||TWO_SIDED|95.0|-29.5|6.0|||ANOVA|||Week 32||6.0|-29.5|
71007652|NCT03481634|141523731|OTHER|Descriptive|LS mean difference|36.3|STANDARD_ERROR_OF_MEAN|11.01|||TWO_SIDED|95.0|14.6|57.9|||ANOVA|||Week 36||57.9|14.6|
71007653|NCT03481634|141523731|OTHER|Descriptive|LS mean difference|20.4|STANDARD_ERROR_OF_MEAN|9.97|||TWO_SIDED|95.0|0.7|40.0|||ANOVA|||Week 36||40.0|0.7|
71102340|NCT01385995|141712671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5||||0.18|TWO_SIDED|95.0|-17.6|3.8|||Regression, Linear|||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and Homeostasis Model Assessment-Insulin Resistance (HOMA-IR), between CPAP and sham-CPAP.||3.8|-17.6|0.18
71102341|NCT01385995|141712671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.1||||0.08|TWO_SIDED|95.0|-27.5|1.8|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of insulin resistance, in this case Homeostasis Model Assessment-Insulin Resistance (HOMA-IR), between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) \>=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=23.||1.8|-27.5|0.08
71007654|NCT03481634|141523731|OTHER|Descriptive|LS mean difference|-6.1|STANDARD_ERROR_OF_MEAN|9.19|||TWO_SIDED|95.0|-24.2|11.9|||ANOVA|||Week 40||11.9|-24.2|
71007655|NCT03481634|141523731|OTHER|Descriptive|LS mean difference|-6.5|STANDARD_ERROR_OF_MEAN|9.5|||TWO_SIDED|95.0|-25.2|12.2|||ANOVA|||Week 40||12.2|-25.2|
71102342|NCT01385995|141712672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7||||0.2|TWO_SIDED|95.0|-2.0|9.8|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, Apnea-Hypopnea Index (AHI), gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and the Insulin Sensivity Index, between CPAP and sham-CPAP.||9.8|-2.0|0.20
71102343|NCT01385995|141712672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.3||||0.002|TWO_SIDED|95.0|5.2|22.1|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and the Insulin Sensitivity Index (ISI(0,120)), between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) \>=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=23.||22.1|5.2|0.002
71102344|NCT02489279|141712805|SUPERIORITY|||||||0.026|||||||GLM with repeated measures ANOVA|||We used a General Linear Model (GLM) with time (Baseline and 10 Weeks) as the within subjects factor, experimental group (Active and Control) as the between subjects factor, and a group by time interaction to test for differential treatment effects. We report the Group x Time interaction.||||0.026
71102345|NCT02489279|141712805|SUPERIORITY|||||||0.0075|||||||t-test, 1 sided|||We then examined the within-subjects factor of Time (Post-Treatment (10 week measure) - Baseline), for each Group, using a 1-tailed t test.||||0.0075
71102346|NCT02489279|141712805|SUPERIORITY|||||||0.25|||||||t-test, 1 sided|||We then examined the within-subjects factor of Time (Post-Treatment (10 week measure) - Baseline), for each Group, using a 1-tailed t test.||||0.25
71102347|NCT02489279|141712806|SUPERIORITY|||||||0.014|||||||GLM with repeated measures ANOVA|||We used a GLM with time (Baseline and 10 Weeks) as the within subjects factor, experimental group (Active and Control) as the between subjects factor, and a group by time interaction to test for differential treatment effects. We report the Group x Time interaction.||||0.014
71102348|NCT02489279|141712806|SUPERIORITY|||||||0.0005|||||||t-test, 1 sided|||We then examined the within-subjects factor of Time (Post-Treatment (10 week measure) - Baseline), for each Group, using a 1-tailed t test.||||0.0005
71102349|NCT02489279|141712806|SUPERIORITY|||||||0.21|||||||t-test, 1 sided|||We then examined the within-subjects factor of Time (Post-Treatment (10 week measure) - Baseline), for each Group, using a 1-tailed t test.||||0.21
71102350|NCT02489279|141712807|SUPERIORITY|||||||1e-06|||||||GLM with repeated measures ANOVA|||We used a GLM with time (Baseline and 10 Weeks) as the within subjects factor, experimental group (Active and Control) as the between subjects factor, and a group by time interaction to test for differential treatment effects. We report only a main effect of Time.||||0.000001
71102351|NCT02489279|141712808|SUPERIORITY|||||||0.00018|||||||GLM with repeated measures ANOVA|||We used a GLM with time (Baseline and 10 Weeks) as the within subjects factor, experimental group (Active and Control) as the between subjects factor, and a group by time interaction to test for differential treatment effects. We report only a main effect of Time.||||0.00018
71102352|NCT00586157|141712819|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Z-test|||||||<.001
71102353|NCT00586157|141712820|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Z-test|||||||.001
71007656|NCT03481634|141523731|OTHER|Descriptive|LS mean difference|7.9|STANDARD_ERROR_OF_MEAN|9.33|||TWO_SIDED|95.0|-10.4|26.3|||ANOVA|||Week 44||26.3|-10.4|
71102354|NCT00586157|141712821|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Z-test|||||||.003
71102355|NCT02014467|141712823|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.42|||<|0.0001|TWO_SIDED|95.0|3.67|5.18|||ANCOVA|||||5.18|3.67|<0.0001
71102356|NCT02014467|141712823|SUPERIORITY_OR_OTHER|||||||0.7495||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.7495
71102357|NCT02014467|141712824|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.21|||<|0.0001|TWO_SIDED|95.0|2.45|3.96|||ANCOVA|||||3.96|2.45|<0.0001
71102358|NCT02014467|141712824|SUPERIORITY_OR_OTHER|||||||0.9029||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.9029
71102359|NCT02014467|141712825|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.26|||<|0.0001|TWO_SIDED|95.0|1.72|2.8|||ANCOVA|||||2.80|1.72|<0.0001
71102360|NCT02014467|141712825|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.1070
71102361|NCT02014467|141712826|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.59|||<|0.0001|TWO_SIDED|95.0|0.98|2.2|||ANCOVA|||||2.20|0.98|<0.0001
71102362|NCT02014467|141712826|SUPERIORITY_OR_OTHER|||||||0.4369||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.4369
71102363|NCT02014467|141712827|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.36|||<|0.0001||95.0|2.39|4.32|||ANCOVA|||||4.32|2.39|<0.0001
71102364|NCT02014467|141712827|SUPERIORITY_OR_OTHER|||||||0.6082||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.6082
71007657|NCT03481634|141523731|OTHER|Descriptive|LS mean difference|1.1|STANDARD_ERROR_OF_MEAN|8.78|||TWO_SIDED|95.0|-16.2|18.3|||ANOVA|||Week 44||18.3|-16.2|
71007658|NCT03481634|141523731|OTHER|Descriptive|LS mean difference|13.6|STANDARD_ERROR_OF_MEAN|9.84|||TWO_SIDED|95.0|-5.8|32.9|||ANOVA|||Week 48||32.9|-5.8|
71007659|NCT03481634|141523731|OTHER|Descriptive|LS mean difference|4.7|STANDARD_ERROR_OF_MEAN|9.26|||TWO_SIDED|95.0|-13.5|23.0|||ANOVA|||Week 48||23.0|-13.5|
71007660|NCT03481634|141523731|OTHER|Descriptive|LS mean difference|4.3|STANDARD_ERROR_OF_MEAN|9.52|||TWO_SIDED|95.0|-14.5|23.0|||ANOVA|||Week 52||23.0|-14.5|
71007661|NCT03481634|141523731|OTHER|Descriptive|LS mean difference|-5.1|STANDARD_ERROR_OF_MEAN|8.78|||TWO_SIDED|95.0|-22.3|12.2|||ANOVA|||Week 52||12.2|-22.3|
71007662|NCT03481634|141523732|OTHER|Descriptive|LS mean difference|1.7|STANDARD_ERROR_OF_MEAN|9.3|||TWO_SIDED|95.0|-16.6|20.0|||ANOVA|||||20.0|-16.6|
71007663|NCT03481634|141523732|OTHER|Descriptive|LS mean difference|-3.5|STANDARD_ERROR_OF_MEAN|8.79|||TWO_SIDED|95.0|-20.7|13.8|||ANOVA|||||13.8|-20.7|
71045296|NCT02709486|141599385|SUPERIORITY||Least Square Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.18||0.0005|TWO_SIDED|95.0|-0.98|-0.27|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.27|-0.98|0.0005
71045297|NCT02709486|141599385|SUPERIORITY||Least Square Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.19||0.0002|TWO_SIDED|95.0|-1.06|-0.33|||ANCOVA|||Week 20: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.33|-1.06|0.0002
71045298|NCT02709486|141599385|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.19||0.0002|TWO_SIDED|95.0|-1.05|-0.32|||ANCOVA|||Week 20: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.32|-1.05|0.0002
71007664|NCT03481634|141523739|OTHER|Descriptive; Week 28|Difference - %|1.6|||||TWO_SIDED|95.0|-5.3|8.4|||Bootstrap method|||||8.4|-5.3|
71007665|NCT03481634|141523739|OTHER|Descriptive; Week 28|Difference - %|4.1|||||TWO_SIDED|95.0|-2.1|10.3|||Bootstrap method|||||10.3|-2.1|
71102365|NCT02014467|141712828|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.31|||<|0.0001|TWO_SIDED|95.0|2.74|3.88|||ANCOVA|||||3.88|2.74|<0.0001
71007666|NCT03481634|141523739|OTHER|Descriptive; Week 52|Difference - %|5.8|||||TWO_SIDED|95.0|-1.2|12.4|||Bootstrap method|||||12.4|-1.2|
71007667|NCT03481634|141523739|OTHER|Descriptive; Week 52|Difference - %|6.7|||||TWO_SIDED|95.0|0.6|12.9|||Bootstrap method|||||12.9|0.6|
71102366|NCT02014467|141712828|SUPERIORITY_OR_OTHER|||||||0.3513||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.3513
71102367|NCT02014467|141712829|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.62|||<|0.0001|TWO_SIDED|95.0|1.96|3.27|||ANCOVA|||||3.27|1.96|<0.0001
71102368|NCT02014467|141712829|SUPERIORITY_OR_OTHER|||||||0.541||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.5410
71102369|NCT02014467|141712830|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.72|||<|0.0001|TWO_SIDED|95.0|3.71|5.72|||ANCOVA|||||5.72|3.71|<0.0001
71102370|NCT02014467|141712830|SUPERIORITY_OR_OTHER|||||||0.3957||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.3957
71102371|NCT02014467|141712831|SUPERIORITY_OR_OTHER||Hodges Lehmann Estimate of Difference|-56.92|||<|0.0001|TWO_SIDED|95.0|-61.38|-52.65||Two-Sided, Wilcoxon t Approximation|Wilcoxon Rank Sum test||s-CTX at Month 6|||-52.65|-61.38|<0.0001
71102372|NCT02014467|141712831|SUPERIORITY_OR_OTHER||Hodges Lehmann Estimate of Difference|-52.56|||<|0.0001||95.0|-59.38|-46.17||Two-Sided, Wilcoxon t Approximation|Wilcoxon Rank Sum test||s-CTX at Month 12|||-46.17|-59.38|<0.0001
71007668|NCT03481634|141523739|OTHER|Descriptive: Week 76|Difference - %|2.8|||||TWO_SIDED|95.0|-3.9|9.4|||Bootstrap method|||||9.4|-3.9|
71007669|NCT03481634|141523739|OTHER|Descriptive: Week 76|Difference - %|0.7|||||TWO_SIDED|95.0|-5.7|7.0|||Bootstrap method|||||7.0|-5.7|
71007670|NCT03481634|141523739|OTHER|Descriptive: Week 100|Difference - %|1.7|||||TWO_SIDED|95.0|-5.0|8.1|||Bootstrap method|||||8.1|-5.0|
71007671|NCT03481634|141523739|OTHER|Descriptive: Week 100|Difference - %|2.2|||||TWO_SIDED|95.0|-4.0|8.4|||Bootstrap method|||||8.4|-4.0|
71007672|NCT03481634|141523741|OTHER|Descriptive; Week 28|Difference - %|-0.3|||||TWO_SIDED|95.0|-6.4|5.8|||Bootstrap method|||||5.8|-6.4|
71007673|NCT03481634|141523741|OTHER|Descriptive; Week 28|Difference - %|4.6|||||TWO_SIDED|95.0|-1.3|11.0|||Bootstrap method|||||11.0|-1.3|
71007674|NCT03481634|141523741|OTHER|Descriptive; Week 52|Difference - %|-4.2|||||TWO_SIDED|95.0|-10.2|2.2|||Bootstrap method|||||2.2|-10.2|
71007675|NCT03481634|141523741|OTHER|Descriptive; Week 52|Difference - %|3.9|||||TWO_SIDED|95.0|-2.2|10.5|||Bootstrap method|||||10.5|-2.2|
71007676|NCT03481634|141523741|OTHER|Descriptive; Week 72|Difference - %|-9.2|||||TWO_SIDED|95.0|-15.5|-2.8|||Bootstrap method|||||-2.8|-15.5|
71007677|NCT03481634|141523741|OTHER|Descriptive; Week 72|Difference - %|-2.3|||||TWO_SIDED|95.0|-8.4|4.4|||Bootstrap method|||||4.4|-8.4|
71007678|NCT03481634|141523741|OTHER|Descriptive; Week 100|Difference - %|-7.7|||||TWO_SIDED|95.0|-14.0|-1.6|||Bootstrap method|||||-1.6|-14.0|
71007679|NCT03481634|141523741|OTHER|Descriptive; Week 100|Difference - %|0.4|||||TWO_SIDED|95.0|-5.7|6.8|||Bootstrap method|||||6.8|-5.7|
71007680|NCT01469637|141523798|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean ratio|1.15|||||TWO_SIDED|90.0|1.12|1.18|||ANOVA|||||1.18|1.12|
70925553|NCT05894577|141344549|OTHER||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.74|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.14|0.74|
70925554|NCT05894577|141344549|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.79|1.22|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.22|0.79|
70925555|NCT05894577|141344549|OTHER||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.71|1.08|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.08|0.71|
70925556|NCT05894577|141344549|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.8|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.21|0.80|
70925557|NCT05894577|141344549|OTHER||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.84|1.29|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.29|0.84|
71007681|NCT01469637|141523799|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean Ratio|1.12|||||TWO_SIDED|90.0|1.09|1.15|||ANOVA|||||1.15|1.09|
71007682|NCT04491591|141523800|SUPERIORITY|||||||0.801|||||||Kruskal-Wallis|||||||0.801
71007683|NCT04491591|141523801|SUPERIORITY|||||||0.1336|||||||Fisher Exact|||Reconstruction versus No reconstruction||||0.1336
71007684|NCT04491591|141523801|SUPERIORITY|Immediate reconstruction versus delayed reconstruction||||||0.5505|||||||Fisher Exact|||||||0.5505
71007685|NCT04491591|141523801|SUPERIORITY|||||||0.6178|||||||Fisher Exact|||Flap reconstruction versus Implant reconstruction||||0.6178
71007686|NCT04491591|141523802|SUPERIORITY|||||||0.2317|||||||Fisher Exact|||||||0.2317
71007687|NCT04491591|141523803|SUPERIORITY|||||||0.1052|||||||Fisher Exact|||||||0.1052
71007688|NCT04491591|141523804|OTHER||||||||||||||||||Within subjects pre/post comparison|||
71007689|NCT04491591|141523805|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71045299|NCT02709486|141599385|SUPERIORITY||Least Square Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.2||0.0506|TWO_SIDED|95.0|-0.78|0.0|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.00|-0.78|0.0506
71045300|NCT02709486|141599385|SUPERIORITY||Least Square Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.2||0.0086|TWO_SIDED|95.0|-0.91|-0.13|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.13|-0.91|0.0086
71102373|NCT02014467|141712832|SUPERIORITY_OR_OTHER||Hodges Lehmann Estimate of Difference|-56.94|||<|0.0001|TWO_SIDED|95.0|-61.6|-52.7||Two-Sided, Wilcoxon t Approximation|Wilcoxon Rank Sum test||s-PINP at Month 6|||-52.70|-61.60|<0.0001
71102374|NCT02014467|141712832|SUPERIORITY_OR_OTHER||Hodges Lehmann Estimate of Difference|-51.21|||<|0.0001|TWO_SIDED|95.0|-56.26|-45.91||Two-Sided, Wilcoxon t Approximation|Wilcoxon Rank Sum test||s-PINP at Month 12|||-45.91|-56.26|<0.0001
71102375|NCT02069847|141712857|SUPERIORITY|||||||0.992|||||||ANOVA|||||||0.992
71102376|NCT02069847|141712858|SUPERIORITY|||||||0.531|||||||t-test, 2 sided|||Total number of budesonide subjects with 50% or greater esophageal stricture (N=4) vs total number of control subjects with 50% or greater esophageal structure (N=15)||||0.531
71102377|NCT00831389|141712859|SUPERIORITY_OR_OTHER|||||||0.791||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median change in PG concentration due to exercise for the OL and CL study phases do not differ.||||0.791
71007690|NCT04491591|141523807|OTHER||||||||||||||||||Descriptive analysis using mean and standard deviation|||
71007691|NCT04491591|141523808|SUPERIORITY|||||||0.0302|||||||Kruskal-Wallis|||||||0.0302
71007692|NCT04491591|141523809|SUPERIORITY|||||||0.135|||||||Fisher Exact|||Reconstruction versus No reconstruction||||0.135
71007693|NCT04491591|141523809|SUPERIORITY|||||||0.51|||||||Fisher Exact|||Immediate reconstruction versus delayed reconstruction||||0.510
71007694|NCT04491591|141523809|SUPERIORITY|||||||0.469|||||||Fisher Exact|||Flap reconstruction versus Implant reconstruction||||0.469
71007695|NCT04491591|141523810|SUPERIORITY|||||||0.308|||||||Fisher Exact|||||||0.308
71007696|NCT04491591|141523811|SUPERIORITY|||||||0.036|||||||Fisher Exact|||||||0.036
71007697|NCT00472043|141523812|SUPERIORITY||||||<|0.001||||||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||||<0.001
71007698|NCT02109939|141523858|SUPERIORITY||Mean Difference (Net)|-2.836|STANDARD_ERROR_OF_MEAN|1.758||0.107|TWO_SIDED|95.0|-6.285|0.613|||Mixed Models Analysis|Repeated Measures including week 4.||||0.613|-6.285|0.1070
71007699|NCT02109939|141523859|SUPERIORITY||Mean Difference (Net)|-2.207|STANDARD_ERROR_OF_MEAN|1.653||0.1822|TWO_SIDED|95.0|-5.45|1.036|||Mixed Models Analysis|MMRM with week 4 data.||||1.036|-5.450|0.1822
71007700|NCT02109939|141523860|SUPERIORITY||Odds Ratio (OR)|1.41||||0.0134|TWO_SIDED|95.0|1.07|1.86|||Generalized linear mixed model|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.||||1.86|1.07|0.0134
71102378|NCT00831389|141712860|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median tally of hypoglycemic events immediately following exercise for the OL and CL study phases do not differ.||||0.5
71007701|NCT02109939|141523863|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0066|TWO_SIDED|95.0|1.14|2.27|||Generalized linear mixed model|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.||||2.27|1.14|0.0066
71007702|NCT02109939|141523866|SUPERIORITY||Odds Ratio (OR)|1.13||||0.2852|TWO_SIDED|95.0|0.9|1.43|||Generalized linear mixed model.|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.||||1.43|0.90|0.2852
71007703|NCT02109939|141523867|SUPERIORITY||Odds Ratio (OR)|1.43||||0.0023|TWO_SIDED|95.0|1.14|1.79|||Generalized linear mixed model|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.||||1.79|1.14|0.0023
71007704|NCT02109939|141523876|SUPERIORITY||Odds Ratio (OR)|1.43||||0.014|TWO_SIDED|95.0|1.07|1.89|||Generalized linear mixed model|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.||||1.89|1.07|0.0140
71007705|NCT02109939|141523877|SUPERIORITY||Odds Ratio (OR)|1.31||||0.0663|TWO_SIDED|95.0|0.98|1.76|||Generalized linear mixed model|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.||||1.76|0.98|0.0663
71007706|NCT01058356|141523884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84|STANDARD_ERROR_OF_MEAN|0.4|<|0.05|TWO_SIDED|95.0|0.17|4.15|||Regression, Logistic|||"Null hypothesis: The efficay of the probiotic Lactobacilli (Lacidofil cap®) for the prevention of AAD in adults is not different form the placebo group in multi-center, randomized, placebo-controlled, double-blind trial.~Power calculation:~The assumption of sample size calculation:~difference 18% (8% : 26%) α: 0.05, statistical power: 90%, two sided difference: 18% Compliance: 80%~\- Unadjusted sample size (N=200) 180 + 10(%) drop out = 180 + 180/ (1-0.1)2 = 222.2 Total 220 subjects"||4.15|0.17|<0.05
71007707|NCT01058356|141523885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85|STANDARD_ERROR_OF_MEAN|0.27|<|0.05|TWO_SIDED|95.0|0.18|1.55|||Regression, Logistic|||"Null hypothesis: The efficay of the probiotic Lactobacilli (Lacidofil cap®) for the prevention of AAD in adults is not different form the placebo group in multi-center, randomized, placebo-controlled, double-blind trial.~Power calculation:~The assumption of sample size calculation:~difference 18% (8% : 26%) α: 0.05, statistical power: 90%, two sided difference: 18% Compliance: 80%~\- Unadjusted sample size (N=200) 180 + 10(%) drop out = 180 + 180/ (1-0.1)2 = 222.2 Total 220 subjects"||1.55|0.18|<0.05
71007708|NCT00606021|141523892|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.1815|TWO_SIDED|95.0|0.42|1.37||The significant level for the primary outcome measure of progression free survival during maintenance phase is one-sided 0.2.|Regression, Cox|Stratified Cox regression model is used for hazard ratio estimate. Stratification factor: response status prior to randomization.||||1.37|0.42|0.1815
71007709|NCT00606021|141523893|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.1233|TWO_SIDED|95.0|0.4|1.26||The significant level for the secondary outcome measure of progression free survival during overall period is one-sided 0.2.|Regression, Cox|Stratified Cox regression model is used for hazard ratio estimate. Stratification factor: response status prior to randomization.||||1.26|0.40|0.1233
71007710|NCT00606021|141523894|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.7239|TWO_SIDED|95.0|0.56|2.28||The significant level for the secondary outcome measure overall survival during maintenance period is two-sided 0.05.|Regression, Cox|Stratified Cox regression model is used for hazard ratio estimate. Stratification factor: response status prior to randomization.||||2.28|0.56|0.7239
71007711|NCT00606021|141523895|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.6376|TWO_SIDED|95.0|0.59|2.38||The significant level for the secondary outcome measure overall survival during overall period is two-sided 0.05.|Regression, Cox|Stratified Cox regression model is used for hazard ratio estimate. Stratification factor: response status prior to randomization.||||2.38|0.59|0.6376
71007712|NCT01928186|141523914|OTHER|||||||0.51|||||||Fisher Exact|the mid-P adjustment to Fisher's exact test||Association between response assessed by Ki-67 protein staining (i.e. \< 10% positive cells in the surgical sample) and by the influx constant Ki decline (i.e. 30 % or larger decline between the baseline and post-therapy FLT PET) was analyzed using the mid-P adjustment to Fisher's exact test.||||0.51
71007713|NCT04540627|141523928|SUPERIORITY|||||||0.5802|||||||Wilcoxon (Mann-Whitney)|||||||0.5802
71007714|NCT04540627|141523929|SUPERIORITY|||||||0.4868|||||||Wilcoxon (Mann-Whitney)|||||||0.4868
71007715|NCT04540627|141523930|SUPERIORITY|||||||0.2681|||||||Wilcoxon (Mann-Whitney)|||||||0.2681
71045301|NCT02709486|141599387|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.07|-0.48|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.48|-1.07|<.0001
71007716|NCT04540627|141523931|SUPERIORITY|||||||0.2431|||||||Wilcoxon (Mann-Whitney)|||||||0.2431
71007717|NCT04540627|141523936|SUPERIORITY|||||||0.4868|||||||Wilcoxon (Mann-Whitney)|||||||0.4868
71007718|NCT04540627|141523938|SUPERIORITY|||||||0.0403|||||||Wilcoxon (Mann-Whitney)|||||||0.0403
71007719|NCT01265719|141523956|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.2||0.1126|TWO_SIDED|95.0|-0.09|0.74|||ANCOVA||Change from baseline to last available observation in BCVA was analyzed using an ANCOVA model with fixed effect for treatment group with baseline BCVA value as covariate.|\<5 years||0.74|-0.09|0.1126
71045302|NCT02709486|141599387|SUPERIORITY||Least Square Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.94|-0.35|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.35|-0.94|<.0001
71045303|NCT02709486|141599387|SUPERIORITY||Least Square Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.03|-0.41|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.41|-1.03|<.0001
71102379|NCT00831389|141712861|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median tally of nocturnal hypoglycemic events following exercise for the OL and CL study phases do not differ.||||0.25
71007720|NCT01265719|141523956|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.04||0.484|TWO_SIDED|95.0|-0.12|0.06|||ANCOVA||Change from baseline to last available observation in BCVA was analyzed using an ANCOVA model with fixed effect for treatment group with baseline BCVA value as covariate.|5 to \<18 years||0.06|-0.12|0.4840
71007721|NCT01265719|141523958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.3||0.902|TWO_SIDED|95.0|-0.63|0.56|||ANCOVA||Change from baseline to last available observation in HCD was analyzed using an ANCOVA model with fixed effect for treatment group with baseline HCD value as covariate.|\<5 years||0.56|-0.63|0.9020
71007722|NCT01265719|141523958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.2||0.8826|TWO_SIDED|95.0|-0.37|0.43|||ANCOVA||Change from baseline to last available observation in HCD was analyzed using an ANCOVA model with fixed effect for treatment group with baseline HCD value as covariate.|5 to \<18 years||0.43|-0.37|0.8826
71007723|NCT01265719|141523959|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.62|STANDARD_ERROR_OF_MEAN|1.25||0.2003|TWO_SIDED|95.0|-4.13|0.89|||ANCOVA||Change from baseline to last available observation in IOP was analyzed using an ANCOVA model with fixed effect for treatment group with baseline IOP value as covariate.|\<5 years||0.89|-4.13|0.2003
71007724|NCT01265719|141523959|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.75||0.894|TWO_SIDED|95.0|-1.59|1.39|||ANCOVA||Change from baseline to last available observation in IOP was analyzed using an ANCOVA model with fixed effect for treatment group with baseline IOP value as covariate.|5 to \<18 years (IOP \<21mmHg at Baseline)||1.39|-1.59|0.8940
71007725|NCT01265719|141523959|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-6.66|STANDARD_ERROR_OF_MEAN|2.41||0.0184|TWO_SIDED|95.0|-11.95|-1.36|||ANCOVA|The results were interpreted with caution because of the very small sample size of non-PG treatment group (n=4).|Change from baseline to last available observation in IOP was analyzed using an ANCOVA model with fixed effect for treatment group with baseline IOP value as covariate.|5 to \<18 years (IOP ≥21mmHg at Baseline)||-1.36|-11.95|0.0184
71007726|NCT01265719|141523960|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.0|||>|0.999|TWO_SIDED|95.0|-13.97|15.9|||Fisher Exact|||||15.90|-13.97|>0.999
71007727|NCT01265719|141523961|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-0.4|||>|0.999|TWO_SIDED|95.0|-15.32|14.55|||Fisher Exact|||||14.55|-15.32|>0.999
71102380|NCT00831389|141712862|SUPERIORITY_OR_OTHER|||||||0.0669||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median peak post-prandial PG for the OL and CL study phases do not differ.||||0.0669
71102381|NCT00831389|141712863|SUPERIORITY_OR_OTHER|||||||0.2256||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median nadir PG immediately following exercise for the OL and CL study phases do not differ.||||0.2256
71007728|NCT01265719|141523962|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.2|||>|0.999|TWO_SIDED|95.0|-13.78|16.09|||Fisher Exact|||||16.09|-13.78|>0.999
71007729|NCT01265719|141523964|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.6||||0.6414|TWO_SIDED|95.0|-13.39|16.48|||Fisher Exact|||||16.48|-13.39|0.6414
71007730|NCT01265719|141523965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.61|STANDARD_ERROR_OF_MEAN|0.52||0.2437|TWO_SIDED|95.0|-0.43|1.65|||ANCOVA||Change from baseline to last available observation in longest lash length (LLL) was analyzed using an ANCOVA model with fixed effect for treatment group with baseline LLL value as covariate.|\<5 years||1.65|-0.43|0.2437
70925558|NCT05894577|141344549|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.68|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||1.14|0.68|
70925559|NCT05894577|141344550|SUPERIORITY|Posterior probability of efficacy (P(Difference in MTU (Active - Placebo)\<0))|Difference in model estimate time unwell|-0.24|||||TWO_SIDED|95.0|-0.6|0.1|||||The mean time unwell is estimated from receipt of study drug to study day 14. The interval is a highest density credible interval.|No hypothesis test or decision rule was evaluated.||0.1|-0.6|
70925560|NCT05894577|141344551|SUPERIORITY|Posterior probability of efficacy (P(Difference days benefit (Active - Placebo)\>0))|Difference in model estimated means|0.31|||||TWO_SIDED|95.0|-0.13|0.75|||||The interval is a highest density credible interval.|Analysis is exploratory. No hypothesis test or decision rule was evaluated.||0.75|-0.13|
70925561|NCT04509674|141344572|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.2061|TWO_SIDED|95.0|0.76|1.06||"Null hypothesis: there is no difference regarding the risk of the endpoint in question between empagliflozin and placebo.~p\<=0.05 required for testing of subsequent key secondary endpoint hypotheses"|Regression, Cox||Empagliflozin vs. Placebo|The primary endpoint was analysed using a Cox proportional hazards model with treatment, type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates.||1.06|0.76|0.2061
70925562|NCT04509674|141344573|OTHER|The statistical model used was a negative binomial model, including factors for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable.|Adjusted event rate ratio|0.87||||0.2423|TWO_SIDED|95.0|0.68|1.1|||Negative binomial regression||Empagliflozin vs. Placebo|||1.10|0.68|0.2423
70925563|NCT04509674|141344574|OTHER|The statistical model used was a negative binomial model, including factors for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable.|Adjusted event rate ratio|0.92||||0.2867|TWO_SIDED|95.0|0.78|1.07|||Negative binomial regression||Empagliflozin vs. Placebo|||1.07|0.78|0.2867
70925564|NCT04509674|141344575|OTHER|The statistical model used was a negative binomial model, including factors for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable.|Adjusted event rate ratio|0.87||||0.0463|TWO_SIDED|95.0|0.7654|0.9978|||Negative binomial regression||Empagliflozin vs. Placebo|||0.9978|0.7654|0.0463
70925565|NCT04509674|141344576|OTHER|The statistical model used was a negative binomial model, including factors for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable.|Adjusted event rate ratio|1.06||||0.6311|TWO_SIDED|95.0|0.83|1.35|||Negative binomial regression||Empagliflozin vs. Placebo|||1.35|0.83|0.6311
71102382|NCT00831389|141712864|SUPERIORITY_OR_OTHER|||||||0.791||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median overnight nadir PG for the OL and CL arms do not differ.||||0.791
71102383|NCT00831389|141712865|SUPERIORITY_OR_OTHER|||||||0.2036||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median percentage of time PG is within euglycemic range for the OL and CL phases do not differ.||||0.2036
71102384|NCT00831389|141712866|SUPERIORITY_OR_OTHER|||||||0.6221||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median percentage of time PG is above euglycemic range for the OL and CL phases do not differ.||||0.6221
71102385|NCT00831389|141712867|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median percentage of time PG is below euglycemic range for the OL and CL phases do not differ.||||0.021
71102386|NCT00831389|141712868|SUPERIORITY_OR_OTHER|||||||0.0176||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median tally of hypoglycemic events over 48 hour in-patient period for the OL and CL phases do not differ.||||0.0176
71007731|NCT01265719|141523965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.32||0.5199|TWO_SIDED|95.0|-0.85|0.43|||ANCOVA||Change from baseline to last available observation in LLL was analyzed using an ANCOVA model with fixed effect for treatment group with baseline LLL value as covariate.|5 to \<18 years||0.43|-0.85|0.5199
71102387|NCT04023045|141712878|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
71007732|NCT01265719|141523966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-2.68|STANDARD_ERROR_OF_MEAN|15.54||0.8643|TWO_SIDED|95.0|-34.3|28.94|||ANCOVA||Change from baseline to last available observation in corneal thickness was analyzed using an ANCOVA model with fixed effect for treatment group with baseline corneal thickness value as covariate.|\<5 years||28.94|-34.30|0.8643
71007733|NCT01265719|141523966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.87|STANDARD_ERROR_OF_MEAN|4.87||0.8591|TWO_SIDED|95.0|-10.54|8.8|||ANCOVA||Change from baseline to last available observation in corneal thickness was analyzed using an ANCOVA model with fixed effect for treatment group with baseline corneal thickness value as covariate.|5 to \<18 years||8.80|-10.54|0.8591
71007734|NCT01265719|141523967|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.5||||0.2413|TWO_SIDED|95.0|-10.49|19.36|||Fisher Exact|||||19.36|-10.49|0.2413
71007735|NCT01722552|141523997|EQUIVALENCE|The margin for non-equivalence was 25 percentage points.|Risk Ratio (RR)|1.59|||<|0.05|TWO_SIDED|95.0|1.21|2.1|||Chi-squared|||The primary analysis was by intent to treat (ITT). This included data for all randomized subjects, with post-intervention adherence measured by the last 30 days of available data; adherence over the entire 6-month intervention period was measured using all available post-intervention data. Our sample size was designed to detect a 25 percentage point difference in proportion achieving optimal adherence post-intervention.||2.1|1.21|<0.05
71007736|NCT02996981|141524022|SUPERIORITY|||||||0.299|||||||Chi-squared|df=1||||||0.299
71007737|NCT01038635|141524030|SUPERIORITY_OR_OTHER||Maximal tolerated dose|75.0|||||TWO_SIDED||||||||Maximal tolerated dose not reached as no dose limiting toxicity documented. MTD considered to be last dose level.|||||
71007738|NCT03018340|141524060|SUPERIORITY||Difference in weighted MMRM LSMs|-1.7|STANDARD_ERROR_OF_MEAN|0.85||0.039|TWO_SIDED|95.0|-3.4|-0.1|||Mixed Models Analysis|||This is the primary statistical comparison for Stage 1 and Stage 2 combined.||-0.1|-3.4|0.0390
71007739|NCT03018340|141524060|SUPERIORITY||Difference in MMRM LSMs|-4.0|STANDARD_ERROR_OF_MEAN|1.09||0.0003|TWO_SIDED|95.0|-6.1|-1.9|||Mixed Models Analysis|||||-1.9|-6.1|0.0003
71007740|NCT03018340|141524060|SUPERIORITY||Difference in MMRM LSMs|0.5|STANDARD_ERROR_OF_MEAN|1.3||0.694|TWO_SIDED|95.0|-2.1|3.1|||Mixed Models Analysis|||||3.1|-2.1|0.6940
71007741|NCT00203294|141524091|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Separate models were fit to the change scores for headache pain, nausea and vomiting, photophobia, phonophobia, and neck pain.|Fisher Exact|||Fisher's exact test was used to compare nominal variables between groups. The Wilcoxon rank-sum test was used to compare interval and ordinal variables between groups.||||<0.01
71007742|NCT00203294|141524091|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Fisher Exact|Wilcoxon rank-sum test was used to compare interval and ordinal variables between groups.||Fisher's exact test was used to compare nominal variables between groups.||||<0.01
71007743|NCT00256204|141524095|SUPERIORITY_OR_OTHER|||||||0.0133|||||||Repeated Measures Mixed Linear Model|||"Hypothesis #1: Slopes Superiority of 1mg Rasagiline over Placebo in the PC Phase Where slope is the model estimate of the change from baseline in total UPDRS per week.~In this analysis, all available post-baseline observations in the PC Phase of the trial are analyzed (ITT efficacy data analysis set, weeks 12, 24 and 36). The placebo groups for rasagiline 1mg (delayed-start) and 2mg (delayed-start)are combined to one placebo group."||||0.0133
71007744|NCT00256204|141524095|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Repeated Measures Mixed Linear Model|||"Hypothesis #1: Slopes Superiority of 2mg Rasagiline over Placebo in the PC Phase Where slope is the model estimate of the change from baseline in total UPDRS per week.~In this analysis, all available post-baseline observations in the PC Phase of the trial are analyzed (ITT efficacy data analysis set, weeks 12, 24 and 36). The placebo groups for rasagiline 1mg (delayed-start)and 2mg (delayed-start) are combined to one placebo group."||||0.0001
71102388|NCT04023045|141712879|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
71102389|NCT04023045|141712880|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
71102390|NCT04023045|141712881|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
71102391|NCT04023045|141712882|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
71102392|NCT04023045|141712883|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
71007745|NCT00256204|141524095|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||The analysis was performed on separate datasets and not on the combined dataset as was pre-specified to account for unexpected interactions of dose level by baseline UPDRS and of dose level by center .|Repeated Measures|||Hypothesis #2: Superiority of Early over Delayed Start at Week 72 In this analysis, observations of subjects entering the active phase with at least 24 weeks of treatment during the PC Phase and at least one available Total UPDRS measurement during the active-treatment phase from weeks 48, 54, 60, 66 or 72, are analyzed (ACTE data analysis set).||||0.0250
71102393|NCT04023045|141712884|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
71102394|NCT04023045|141712885|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
71102395|NCT00841815|141712886|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|96.43||||||90.0|91.4|101.74|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.74|91.40|
71102396|NCT00841815|141712887|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|100.94||||||90.0|95.6|106.58|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||106.58|95.60|
71007746|NCT00256204|141524095|SUPERIORITY_OR_OTHER|||||||0.6028||95.0||||The analysis was performed on separate datasets and not on the combined dataset as was pre-specified to account for unexpected interactions of dose level by baseline UPDRS and of dose level by center|Repeated Measures|||Hypothesis #2:Superiority of Early over Delayed Start at Week 72 In this analysis, observations of subjects entering the active phase with at least 24 weeks of treatment during the PC Phase and at least one available Total UPDRS measurement during the active-treatment phase from weeks 48, 54, 60, 66 or 72, are analyzed (ACTE data analysis set.)||||0.6028
71007747|NCT00256204|141524095|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inf Test for difference in slopes between treatment groups. One sided 95% CI calculated for difference between slopes of the 1mg early-start group and the 1mg delayed-start group. The inferiority null hypothesis of the early-start group slope over delayed-start group slope is rejected, if the upper limit of one sided 95% CI for difference in slopes does not cross non-inferiority margin of 0.15 UPDRS points per week.|Slope|0.0||||||90.0|-0.036|0.036||||||"Hypothesis #3: Slopes Non-Inferiority of Early Start over Delayed Start in the Active Phase.~Where slope is the model estimate of the change from baseline in total UPDRS per week. In this analysis, observations of all subjects entering the active phase with at least 24 weeks of treatment during the PC Phase and at least one available Total UPDRS measurement during the active treatment phase from weeks 48, 54, 60, 66 or 72, are analyzed (ACTE data analysis set)."||0.036|-0.036|
71007748|NCT00256204|141524095|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inf Test for difference in slopes between treatment groups. One sided 95% CI calculated for difference between slopes of the 2mg early-start group and the 2mg delayed-start group. The inferiority null hypothesis of the early-start group slope over delayed-start group slope is rejected, if the upper limit of one sided 95% CI for difference in slopes does not cross non-inferiority margin of 0.15 UPDRS points per week.|Slope|0.029||||||90.0|-0.005|0.062||||||"Hypothesis #3: Slopes Non-Inferiority of Early Start over Delayed Start in the Active Phase.~Where slope is the model estimate of the change from baseline in total UPDRS per week. In this analysis, observations of all subjects entering the active phase with at least 24 weeks of treatment during the PC Phase and at least one available Total UPDRS measurement during the active treatment phase from weeks 48, 54, 60, 66 or 72, are analyzed (ACTE data analysis set)."||0.062|-0.005|
71007749|NCT00256204|141524096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.005|||<|0.0001||95.0|-3.857|-2.153|||ANCOVA|||The adjusted means of the changes in Total UPDRS from baseline to LOV in the placebo-controlled phase, observed in the 1 mg and 2 mg rasagiline early-start groups are compared (two contrasts) to the combined placebo group (1 mg and 2 mg rasagiline delayed-start groups), by applying an Analysis of Covariance model. The model includes treatment group, center and baseline Total UPDRS as covariates. For this analysis, both delayed start arms are pooled as a 'placebo arm'||-2.153|-3.857|<0.0001
71007750|NCT00256204|141524096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.154|||<|0.0001||95.0|-4.004|-2.305|||ANCOVA|||"The adjusted means of the changes in Total UPDRS from baseline to LOV in the placebo-controlled phase, observed in the 1 mg and 2 mg rasagiline early-start groups are compared (two contrasts) to the combined placebo group (1 mg and 2 mg rasagiline delayed-start groups), by applying an Analysis of Covariance model. The model includes treatment group, center and baseline Total UPDRS as covariates.~For this analysis, both delayed start arms are pooled as a 'placebo arm'"||-2.305|-4.004|<0.0001
71007751|NCT03427528|141524097|OTHER|To assess paternal and maternal outcomes on the BDI-II we conducted a series of paired t-tests with Bonferroni correction for multiple comparisons. T-tests compared baseline scores on each outcome to 3-month follow-up scores, with separate t-tests conducted to examine changes between baseline and 6-month follow-up. We used a Cohen's d statistic to indicate effect sizes for our BDI-II.|||||<|0.05|||||||Paired T-test|||We used a single group longitudinal pre-post design to evaluate study outcomes||||<0.05
71007752|NCT03427528|141524098|OTHER|To assess paternal and maternal outcomes on the GAD-7, we conducted a series of paired t-tests with Bonferroni correction for multiple comparisons. T-tests compared baseline scores on each outcome to 3-month follow-up scores, with separate t-tests conducted to examine changes between baseline and 6-month follow-up. We used a Cohen's d statistic to indicate effect sizes for our outcomes.|||||>|0.05|||||||Paired T-test|||We used a single group longitudinal pre-post design to evaluate study outcomes||||>0.05
71102397|NCT00841815|141712888|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|100.11||||||90.0|95.08|105.4|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.40|95.08|
71102398|NCT04805593|141712889|SUPERIORITY|Superiority testing was conducted to confirm the proportion is higher than the targeted value of 50%.|||||<|0.0001|||||||Exact Test of Binomial Proportion|||||||<0.0001
71102399|NCT04805593|141712890|SUPERIORITY|Superiority testing was conducted to confirm the proportion is higher than the targeted value of 75%.|||||<|0.0001|||||||Exact Test of Binomial Proportion|||||||<0.0001
71102400|NCT03464461|141712898|OTHER|non-parametric||||||0.9844|||||||Kruskal-Wallis|||||||0.9844
71102401|NCT03464461|141712899|OTHER|non-parametric||||||0.158|||||||Kruskal-Wallis|||||||0.1580
71102402|NCT03464461|141712900|OTHER|non-parametric||||||0.873|||||||Kruskal-Wallis|||||||0.8730
71102403|NCT03464461|141712901|OTHER|non-parametric||||||0.074|||||||Kruskal-Wallis|||||||0.0740
71102404|NCT03464461|141712902|OTHER|non-parametric||||||0.0984|||||||Kruskal-Wallis|||||||0.0984
71102405|NCT03685149|141712906|SUPERIORITY||percent reduction|72.0|||<|0.0001|TWO_SIDED|95.0|56.0|82.0|||Mixed Models Analysis|||||82|56|<0.0001
71102406|NCT03685149|141712907|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.00
71007753|NCT03427528|141524099|OTHER|To assess paternal and maternal outcomes on the PSS-10, we conducted a series of paired t-tests with Bonferroni correction for multiple comparisons. T-tests compared baseline scores on each outcome to 3-month follow-up scores, with separate t-tests conducted to examine changes between baseline and 6-month follow-up. We used a Cohen's d statistic to indicate effect sizes for our PSS-10 outcomes.|||||<|0.05|||||||Paired T-test|||We used a single group longitudinal pre-post design to evaluate study outcomes||||<0.05
71007754|NCT03427528|141524099|OTHER|To assess paternal and maternal outcomes on the PSS-10 we conducted a series of paired t-tests with Bonferroni correction for multiple comparisons. T-tests compared baseline scores on each outcome to 3-month follow-up scores, with separate t-tests conducted to examine changes between baseline and 6-month follow-up. We used a Cohen's d statistic to indicate effect sizes for our PSS-10 outcomes.|||||<|0.05|||||||Paired T-test|||We used a single group longitudinal pre-post design to evaluate study outcomes||||<0.05
71007755|NCT03427528|141524100|OTHER||||||>|0.05|||||||t-test, 2 sided|||We used a single group longitudinal pre-post design to evaluate study outcomes||||>0.05
71007756|NCT00808132|141524104|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|1.51|||<|0.001|TWO_SIDED|95.0|0.822|2.201|||ANCOVA|||Analysis of covariance (ANCOVA) model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||2.201|0.822|<0.001
71007757|NCT00808132|141524104|SUPERIORITY_OR_OTHER||LS Mean Difference|1.87|||<|0.001|TWO_SIDED|95.0|1.209|2.533|||ANCOVA|||ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||2.533|1.209|<0.001
71007758|NCT00808132|141524105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8||||0.017|TWO_SIDED|95.0|0.139|1.47|||ANCOVA|||ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||1.470|0.139|0.017
71007759|NCT00808132|141524105|SUPERIORITY_OR_OTHER||LS Mean Difference|1.19|||<|0.001|TWO_SIDED|95.0|0.556|1.83|||ANCOVA|||ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||1.830|0.556|<0.001
71007760|NCT00808132|141524106|SUPERIORITY_OR_OTHER||LS Mean Difference|1.32|||<|0.001|TWO_SIDED|95.0|0.901|1.742|||ANCOVA|||Month 6: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||1.742|0.901|<0.001
71007761|NCT00808132|141524106|SUPERIORITY_OR_OTHER||LS Mean Difference|1.21|||<|0.001|TWO_SIDED|95.0|0.756|1.671|||ANCOVA|||Month 12: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||1.671|0.756|<0.001
71007762|NCT00808132|141524106|SUPERIORITY_OR_OTHER||LS Mean Difference|1.56|||<|0.001|TWO_SIDED|95.0|1.152|1.962|||ANCOVA|||Month 6: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||1.962|1.152|<0.001
71007763|NCT00808132|141524106|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|||<|0.001|TWO_SIDED|95.0|1.164|2.044|||ANCOVA|||Month 12: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||2.044|1.164|<0.001
71007764|NCT00808132|141524107|SUPERIORITY_OR_OTHER|||||||0.138|TWO_SIDED||||||Fisher Exact|||||||0.138
71007765|NCT00808132|141524107|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
71007766|NCT00808132|141524107|SUPERIORITY_OR_OTHER|||||||0.765|TWO_SIDED||||||Fisher Exact|||||||0.765
71007767|NCT00808132|141524107|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
71007768|NCT00808132|141524107|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
71007769|NCT00808132|141524108|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06||||0.832|TWO_SIDED|95.0|-0.632|0.509|||ANCOVA|||ANCOVA model was used with treatment and region as factors and baseline as a covariate.||0.509|-0.632|0.832
71007770|NCT00808132|141524108|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13||||0.651|TWO_SIDED|95.0|-0.696|0.436|||ANCOVA|||ANCOVA model was used with treatment and region as factors and baseline as a covariate.||0.436|-0.696|0.651
71007771|NCT00808132|141524109|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71007772|NCT00808132|141524109|SUPERIORITY_OR_OTHER|||||||0.0074|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0074
71007773|NCT00808132|141524109|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71007774|NCT00808132|141524109|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71007775|NCT00808132|141524109|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71007776|NCT00808132|141524109|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71007777|NCT00808132|141524109|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71007778|NCT00808132|141524109|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71007779|NCT00808132|141524109|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71007780|NCT00808132|141524109|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0016
71007781|NCT00808132|141524109|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71007782|NCT00808132|141524109|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71102407|NCT03685149|141712908|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
70925566|NCT04509674|141344577|OTHER|The statistical analysis was performed using a Cox proportional hazards model with treatment, type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates.|Hazard Ratio (HR)|1.03||||0.8124||95.0|0.81|1.31|||Regression, Cox||Empagliflozin vs. Placebo|||1.31|0.81|0.8124
70925567|NCT03476460|141344584|NON_INFERIORITY|"We considered a priori a difference of no more than 5% in the incidence of CA-AKI in the oral compared to the intravenous arm (non-inferiority margin) to be acceptable.~The non-inferiority of oral hydration would be shown if the upper limit of the 95% CI of the absolute risk difference between the groups was less than 5% (non-inferiority margin, indicated by the black dashed line)"|Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-4.8|7.0|||||The 95% confidence interval for the difference between the two independent proportions was calculated according to Wilson's method.|Sample size was calculated to assess the non-inferiority of oral compared to intravenous hydration. We expected a primary outcome rate of 7% in the intravenous arm. We considered a priori a difference of no more than 5% in the incidence of CA-AKI in the oral compared to the intravenous arm (non-inferiority margin) to be acceptable. Thus, 266 participants, 133 per arm, were required to ensure at least 80% power at a significance level of α = 2.5% (one-sided).||7.0|-4.8|
70925568|NCT03476460|141344585|SUPERIORITY|||||||0.299||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||Comparison between means of both arms at 24h from baseline||||0.299
70925569|NCT03476460|141344586|SUPERIORITY|||||||0.477||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||Comparison between means of both arms at 48h from baseline||||0.477
70925570|NCT03476460|141344587|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.042||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||||||0.042
70925571|NCT03476460|141344588|SUPERIORITY|Comparison between means of both arms at 48h from baseline||||||0.121||||||A p-value \<0.05 (two-sided) was considered for statistical significance|t-test, 2 sided|||||||0.121
70925572|NCT03476460|141344589|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.418||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||||||0.418
70925573|NCT03476460|141344590|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.901||||||A p-value \<0.05 (two-sided) was considered for statistical significance|t-test, 2 sided|||||||0.901
70925574|NCT03476460|141344591|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.72||||||A p-value \<0.05 (two-sided) was considered for statistical significance|Wilcoxon (Mann-Whitney)|||||||0.720
70925575|NCT03476460|141344592|SUPERIORITY|Comparison between means of both arms at 48h from baseline||||||0.688||||||A p-value \<0.05 (two-sided) was considered for statistical significance|Wilcoxon (Mann-Whitney)|||||||0.688
70925576|NCT03476460|141344593|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.535||||||A p-value \<0.05 (two-sided) was considered for statistical significance|t-test, 2 sided|||||||0.535
70925577|NCT03476460|141344594|SUPERIORITY|Comparison between means of both arms at 48h from baseline||||||0.338||||||A p-value \<0.05 (two-sided) was considered for statistical significance|t-test, 2 sided|||||||0.338
70925578|NCT03476460|141344595|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.764||||||A p-value \<0.05 (two-sided) was considered for statistical significance|t-test, 2 sided|||||||0.764
70925579|NCT03476460|141344596|SUPERIORITY|Comparison between means of both arms at 48h from baseline||||||0.458||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||||||0.458
70925580|NCT03476460|141344597|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.893||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||||||0.893
71007783|NCT00808132|141524109|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71007784|NCT00808132|141524109|SUPERIORITY_OR_OTHER|||||||0.1058|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.1058
70925581|NCT03476460|141344598|SUPERIORITY|Comparison between means of both arms at 48h from baseline||||||0.645||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||||||0.645
70925582|NCT01606215|141344628|OTHER|||||||0.84|||||||t-test, 2 sided|||Week 4 data||||0.84
70925583|NCT01606215|141344628|OTHER|||||||0.62|||||||t-test, 2 sided|||Week 12 data||||0.62
71007785|NCT00808132|141524109|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71007786|NCT00808132|141524109|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0024
71007787|NCT00808132|141524109|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71102408|NCT03685149|141712909|SUPERIORITY|||||||0.207|||||||Wilcoxon (Mann-Whitney)|||||||0.207
71102409|NCT03647137|141712923|OTHER||Standardized β Coefficient|-2.256||||0.00468|TWO_SIDED|||||The p-value is derived from model comparison between the FEOVB model and the FEOVB\*PIB interaction model.|ChiSq Goodness of Fit Test|||L-DOPA sensitivity outcome measure was modeled with 3-level hierarchical ordinal logistic regression. The null model contained only striatal DTBZ as predictor of group, the FEOVB model additionally had FEOVB tracer, and interaction model had in addition an interaction term between FEOVB and PIB tracer. Model comparisons were performed using Chi-Square goodness of fit test.||||0.00468
71102410|NCT00209131|141712953|NON_INFERIORITY_OR_EQUIVALENCE||||||<|0.05||95.0|||||Other|||No analysis was conducted.||||<0.05
71102411|NCT04918771|141713012|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.0003|TWO_SIDED|95.0|0.51|1.67|||t-test, 2 sided|||Mean time to resolution of ARVI symptoms||1.67|0.51|0.0003
71102412|NCT04918771|141713013|SUPERIORITY||Mean Difference (Final Values)|2.35||||0.3274|TWO_SIDED|95.0|-2.36|7.06|||t-test, 2 sided|||Mean AUC score for severity of ARVI (Clinically Diagnosed and/or PCR-confirmed).||7.06|-2.36|0.3274
71045304|NCT02709486|141599387|SUPERIORITY||Least Square Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.15|-0.53|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.53|-1.15|<.0001
71045305|NCT02709486|141599387|SUPERIORITY||Least Square Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.17||0.0004|TWO_SIDED|95.0|-0.91|-0.26|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.26|-0.91|0.0004
71045306|NCT02709486|141599387|SUPERIORITY||Least Square Mean Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.31|-0.67|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.67|-1.31|<.0001
71045307|NCT02709486|141599387|SUPERIORITY||Least Square Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.14|-0.46|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.46|-1.14|<.0001
71045308|NCT02709486|141599387|SUPERIORITY||Least Square Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.18|-0.5|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.50|-1.18|<.0001
71045309|NCT02709486|141599387|SUPERIORITY||Least Square Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.18||0.0002|TWO_SIDED|95.0|-1.0|-0.3|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.30|-1.00|0.0002
71045310|NCT02709486|141599387|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.12|-0.43|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.43|-1.12|<.0001
71045311|NCT02709486|141599387|SUPERIORITY||Least Square Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.19||0.0013|TWO_SIDED|95.0|-0.99|-0.24|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.24|-0.99|0.0013
71045312|NCT02709486|141599387|SUPERIORITY||Least Square Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.25|-0.5|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.50|-1.25|<.0001
71045313|NCT02709486|141599389|SUPERIORITY||Least Square Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.96|-0.45|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.45|-0.96|<.0001
71045314|NCT02709486|141599389|SUPERIORITY||Least Square Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.13||0.0004|TWO_SIDED|95.0|-0.73|-0.21|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.21|-0.73|0.0004
71045315|NCT02709486|141599389|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.04|-0.49|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.49|-1.04|<.0001
71102413|NCT04918771|141713013|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.1171|TWO_SIDED|95.0|-1.34|11.93|||t-test, 2 sided|||Mean AUC score for severity of ARVI (PCR-confirmed).||11.93|-1.34|0.1171
71102414|NCT04918771|141713014|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71102415|NCT04918771|141713015|SUPERIORITY||Mean Difference (Final Values)|0.58||||0.0073|TWO_SIDED|95.0|0.16|1.0|||t-test, 2 sided|||The mean time to Resolution of ARVI Symptoms was analysed.||1.00|0.16|0.0073
71102416|NCT04918771|141713016|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71102417|NCT04918771|141713017|SUPERIORITY|||||||0.3627|||||||Wilcoxon (Mann-Whitney)|||Dosing Frequency of Antipyretics. Comparison for Day 1.||||0.3627
71102418|NCT04918771|141713017|SUPERIORITY|||||||0.5578|||||||Wilcoxon (Mann-Whitney)|||Dosing Frequency of Antipyretics. Comparison for Day 2.||||0.5578
70925584|NCT01606215|141344628|OTHER|||||||0.61|||||||t-test, 2 sided|||Week 24 data||||0.61
70925585|NCT01606215|141344631|OTHER|||||||0.77|||||||t-test, 2 sided|||Week 4||||0.77
71007788|NCT00808132|141524109|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71007789|NCT00808132|141524109|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71007790|NCT00808132|141524109|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71007791|NCT00808132|141524109|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71007792|NCT00808132|141524109|SUPERIORITY_OR_OTHER|||||||0.0012|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0012
71007793|NCT00808132|141524109|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71007794|NCT00808132|141524109|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71007795|NCT00808132|141524109|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71007796|NCT00808132|141524109|SUPERIORITY_OR_OTHER|||||||0.0029|TWO_SIDED||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0029
71045316|NCT02709486|141599389|SUPERIORITY||Least Square Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.08|-0.53|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.53|-1.08|<.0001
70925586|NCT01606215|141344631|OTHER|||||||0.68|||||||t-test, 2 sided|||Week 12||||0.68
71007797|NCT00808132|141524109|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71102419|NCT04918771|141713017|SUPERIORITY|||||||0.7688|||||||Wilcoxon (Mann-Whitney)|||Dosing Frequency of Antipyretics. Comparison for Day 3.||||0.7688
70925587|NCT01606215|141344631|OTHER|Week 24||||||0.48|||||||t-test, 2 sided|||Week 24||||0.48
70925588|NCT05349500|141344663|SUPERIORITY||Mean Difference (Final Values)|-11.0||||0.019|TWO_SIDED|95.0|-20.1|-1.9|||Mixed Models Analysis|||||-1.9|-20.1|0.019
70925589|NCT05349500|141344664|SUPERIORITY||Mean Difference (Final Values)|-4.9||||0.286|TWO_SIDED|95.0|-14.1|4.3|||Mixed Models Analysis|||||4.3|-14.1|0.286
70925590|NCT05349500|141344665|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.046|TWO_SIDED|95.0|-4.0|0.0|||Mixed Models Analysis|||||-0.0|-4.0|0.046
70925591|NCT05349500|141344666|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.128|TWO_SIDED|95.0|-3.8|0.5|||Mixed Models Analysis|||||0.5|-3.8|0.128
70925592|NCT05349500|141344667|SUPERIORITY||Mean Difference (Final Values)|-7.5||||0.031|TWO_SIDED|95.0|-14.3|-0.7|||Mixed Models Analysis|||||-0.7|-14.3|0.031
70925593|NCT05349500|141344668|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.564|TWO_SIDED|95.0|-8.8|4.9|||Mixed Models Analysis|||||4.9|-8.8|0.564
70925594|NCT05349500|141344669|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.349|TWO_SIDED|95.0|-0.2|0.6|||Mixed Models Analysis|||||0.6|-0.2|0.349
70925595|NCT05349500|141344670|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.303|TWO_SIDED|95.0|-0.6|0.2|||Mixed Models Analysis|||||0.2|-0.6|0.303
71007798|NCT00808132|141524109|SUPERIORITY_OR_OTHER|||||||0.0046|TWO_SIDED||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0046
71007799|NCT00808132|141524109|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71007800|NCT00808132|141524109|SUPERIORITY_OR_OTHER|||||||0.0043|TWO_SIDED||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0043
71007801|NCT00808132|141524109|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71007802|NCT00808132|141524109|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71007803|NCT00808132|141524109|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0016
71007804|NCT00808132|141524109|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71007805|NCT00808132|141524109|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71007806|NCT00808132|141524109|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71007807|NCT00808132|141524111|SUPERIORITY_OR_OTHER|||||||0.546|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 1-4: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.546
71007808|NCT00808132|141524111|SUPERIORITY_OR_OTHER|||||||0.821|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 5-8: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.821
71007809|NCT00808132|141524111|SUPERIORITY_OR_OTHER|||||||0.698|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 9-12: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.698
71007810|NCT00808132|141524111|SUPERIORITY_OR_OTHER|||||||0.446|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 13-16: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.446
71045317|NCT02709486|141599389|SUPERIORITY||Least Square Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.9|-0.32|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.32|-0.90|<.0001
71045318|NCT02709486|141599389|SUPERIORITY||Least Square Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.13|-0.56|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.56|-1.13|<.0001
71045319|NCT02709486|141599389|SUPERIORITY||Least Square Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.09|-0.47|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.47|-1.09|<.0001
71045320|NCT02709486|141599389|SUPERIORITY||Least Square Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.12|-0.5|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.50|-1.12|<.0001
71045321|NCT02709486|141599389|SUPERIORITY||Least Square Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.16||0.0001|TWO_SIDED|95.0|-0.95|-0.35|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.35|-0.95|0.0001
71045322|NCT02709486|141599389|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-0.99|-0.35|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.35|-0.99|<.0001
71045323|NCT02709486|141599389|SUPERIORITY||Least Square Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.17||0.0015|TWO_SIDED|95.0|-0.89|-0.21|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.21|-0.89|0.0015
71045324|NCT02709486|141599389|SUPERIORITY||Least Square Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.07|-0.39|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.39|-1.07|<.0001
71102420|NCT04918771|141713018|SUPERIORITY|||||||0.4926|||||||Fisher Exact|||||||0.4926
71102421|NCT04918771|141713019|SUPERIORITY|||||||0.021|||||||Fisher Exact|||Comparison of severity distributions.||||0.021
70925596|NCT05349500|141344671|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.507|TWO_SIDED|95.0|-0.1|0.2|||Mixed Models Analysis|||||0.2|-0.1|0.507
71045325|NCT02709486|141599391|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.96|-0.38|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.38|-0.96|<.0001
71045326|NCT02709486|141599391|SUPERIORITY||Least Square Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.15||0.0139|TWO_SIDED|95.0|-0.67|-0.08|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.08|-0.67|0.0139
71102422|NCT04918771|141713019|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison for outcome distribution.||||1.00
71102423|NCT04918771|141713020|SUPERIORITY|||||||0.7848|||||||Median test|||Comparison for Visit 1.||||0.7848
71102424|NCT04918771|141713020|SUPERIORITY|||||||0.9596|||||||Median test|||Comparison for Visit 2.||||0.9596
71102425|NCT04918771|141713020|SUPERIORITY|||||||0.6902|||||||Median test|||Comparison for Visit 3.||||0.6902
71102426|NCT04918771|141713021|SUPERIORITY|||||||0.3266|||||||Median test|||Comparison for Visit 1.||||0.3266
71102427|NCT04918771|141713021|SUPERIORITY|||||||0.093|||||||Median test|||Comparison for Visit 2.||||0.0930
71102428|NCT04918771|141713021|SUPERIORITY|||||||0.2308|||||||Median test|||Comparison for Visit 3.||||0.2308
71102429|NCT04918771|141713022|SUPERIORITY|||||||0.661|||||||Median test|||Comparison for Visit 1/Systolic blood pressure.||||0.6610
71102430|NCT04918771|141713022|SUPERIORITY|||||||0.4884|||||||Median test|||Comparison for Visit 2/Systolic blood pressure.||||0.4884
71102431|NCT04918771|141713022|SUPERIORITY|||||||0.3494|||||||Median test|||Comparison for Visit 3/Systolic blood pressure.||||0.3494
71102432|NCT04918771|141713022|SUPERIORITY|||||||0.9531|||||||Median test|||Comparison for Visit 1/Diastolic blood pressure.||||0.9531
70925597|NCT05349500|141344672|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.729|TWO_SIDED|95.0|-0.2|0.2|||Mixed Models Analysis|||||0.2|-0.2|0.729
70925598|NCT05349500|141344673|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.421|TWO_SIDED|95.0|-0.2|0.1|||Mixed Models Analysis|||||0.1|-0.2|0.421
71007811|NCT00808132|141524111|SUPERIORITY_OR_OTHER|||||||0.892|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 17-20: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.892
71007812|NCT00808132|141524111|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 21-24: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.810
71007813|NCT00808132|141524111|SUPERIORITY_OR_OTHER|||||||0.473|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 25-28: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.473
71007814|NCT00808132|141524111|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 29-32: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.030
71007815|NCT00808132|141524111|SUPERIORITY_OR_OTHER|||||||0.453|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 33-36: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.453
71007816|NCT00808132|141524111|SUPERIORITY_OR_OTHER|||||||0.391|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 37-40: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.391
71007817|NCT00808132|141524111|SUPERIORITY_OR_OTHER|||||||0.407|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 41-44: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.407
71007818|NCT00808132|141524111|SUPERIORITY_OR_OTHER|||||||0.644|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 45-48: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.644
71007819|NCT00808132|141524111|SUPERIORITY_OR_OTHER|||||||0.666|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 49-52: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.666
71007820|NCT00808132|141524111|SUPERIORITY_OR_OTHER|||||||0.641|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 1-4: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.641
71007821|NCT00808132|141524111|SUPERIORITY_OR_OTHER|||||||0.361|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 5-8: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.361
71007822|NCT00808132|141524111|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 9-12: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.100
71007823|NCT00808132|141524111|SUPERIORITY_OR_OTHER|||||||0.142|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 13-16: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.142
71045327|NCT02709486|141599391|SUPERIORITY||Least Square Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.13|-0.51|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.51|-1.13|<.0001
71102433|NCT04918771|141713022|SUPERIORITY|||||||0.5506|||||||Median test|||Comparison for Visit 2/Diastolic blood pressure.||||0.5506
71102434|NCT04918771|141713022|SUPERIORITY|||||||0.8259|||||||Median test|||Comparison for Visit 3/Diastolic blood pressure.||||0.8259
70925599|NCT05349500|141344674|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.648|TWO_SIDED|95.0|-0.2|0.1|||Mixed Models Analysis|||||0.1|-0.2|0.648
70925600|NCT05349500|141344675|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.034|TWO_SIDED|95.0|0.3|6.5|||Mixed Models Analysis|||||6.5|0.3|0.034
71007824|NCT00808132|141524111|SUPERIORITY_OR_OTHER|||||||0.906|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 17-20: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.906
71007825|NCT00808132|141524111|SUPERIORITY_OR_OTHER|||||||0.798|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 21-24: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.798
71007826|NCT00808132|141524111|SUPERIORITY_OR_OTHER|||||||0.258|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 25-28: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.258
71007827|NCT00808132|141524111|SUPERIORITY_OR_OTHER|||||||0.058|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 29-32: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.058
71007828|NCT00808132|141524111|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 33-36: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.230
71007829|NCT00808132|141524111|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 37-40: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.360
71007830|NCT00808132|141524111|SUPERIORITY_OR_OTHER|||||||0.892|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 41-44: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.892
71007831|NCT00808132|141524111|SUPERIORITY_OR_OTHER|||||||0.912|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 45-48: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.912
71007832|NCT00808132|141524111|SUPERIORITY_OR_OTHER|||||||0.791|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 49-52: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.791
71007833|NCT00808132|141524112|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.93||||0.253|TWO_SIDED|95.0|-7.96|2.1|||ANCOVA|||Sleep disturbance: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||2.10|-7.96|0.253
71007834|NCT00808132|141524112|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.84||||0.127|TWO_SIDED|95.0|-8.78|1.1|||ANCOVA|||Sleep disturbance: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.10|-8.78|0.127
71007835|NCT00808132|141524112|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.15||||0.18|TWO_SIDED|95.0|-7.76|1.46|||ANCOVA|||Snoring: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.46|-7.76|0.180
71007836|NCT00808132|141524112|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.67||||0.247|TWO_SIDED|95.0|-7.19|1.85|||ANOVA|||Snoring: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.85|-7.19|0.247
71007837|NCT00808132|141524112|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.63||||0.726|TWO_SIDED|95.0|-4.15|2.9|||ANCOVA|||ASoB: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||2.90|-4.15|0.726
71007838|NCT00808132|141524112|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.17||||0.218|TWO_SIDED|95.0|-5.63|1.29|||ANCOVA|||ASoB: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.29|-5.63|0.218
71007839|NCT00808132|141524112|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01||||0.996|TWO_SIDED|95.0|-3.85|3.87|||ANCOVA|||Somnolence: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||3.87|-3.85|0.996
71102435|NCT04918771|141713023|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
71045328|NCT02709486|141599391|SUPERIORITY||Least Square Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.16|-0.55|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.55|-1.16|<.0001
71045329|NCT02709486|141599391|SUPERIORITY||Least Square Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.16||0.0003|TWO_SIDED|95.0|-0.91|-0.27|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.27|-0.91|0.0003
71045330|NCT02709486|141599391|SUPERIORITY||Least Square Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.04|-0.4|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.40|-1.04|<.0001
71045331|NCT02709486|141599391|SUPERIORITY||Least Square Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.08|-0.39|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.39|-1.08|<.0001
70925601|NCT05349500|141344676|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.315|TWO_SIDED|95.0|-2.1|6.3|||Mixed Models Analysis|||||6.3|-2.1|0.315
71007840|NCT00808132|141524112|SUPERIORITY_OR_OTHER||LS Mean DIfference|0.83||||0.665|TWO_SIDED|95.0|-2.94|4.6|||ANCOVA|||Somnolence: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||4.60|-2.94|0.665
71007841|NCT00808132|141524112|SUPERIORITY_OR_OTHER||LS Mean Difference|2.76||||0.368|TWO_SIDED|95.0|-3.26|8.78|||ANOVA|||Sleep adequacy: Month 3, ANCOVA model was used with treatment and region as factors and baseline as a covariate.||8.78|-3.26|0.368
71007842|NCT00808132|141524112|SUPERIORITY_OR_OTHER||LS Mean Difference|2.84||||0.345|TWO_SIDED|95.0|-3.07|8.75|||ANCOVA|||Sleep adequacy: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||8.75|-3.07|0.345
71007843|NCT00808132|141524112|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.35||||0.482|TWO_SIDED|95.0|-5.12|2.42|||ANCOVA|||Sleep problem index I: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||2.42|-5.12|0.482
71045332|NCT02709486|141599391|SUPERIORITY||Least Square Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.14|-0.44|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.44|-1.14|<.0001
71007844|NCT00808132|141524112|SUPERIORITY_OR_OTHER||LS Mean DIfference|-2.15||||0.254|TWO_SIDED|95.0|-5.86|1.55|||ANCOVA|||Sleep problem index I: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.55|-5.86|0.254
71045333|NCT02709486|141599391|SUPERIORITY||Least Square Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.18||0.0006|TWO_SIDED|95.0|-0.98|-0.27|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.27|-0.98|0.0006
71045334|NCT02709486|141599391|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.18||0.0009|TWO_SIDED|95.0|-0.96|-0.25|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.25|-0.96|0.0009
71045335|NCT02709486|141599391|SUPERIORITY||Least Square Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.0377|TWO_SIDED|95.0|-0.78|-0.02|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.02|-0.78|0.0377
71045336|NCT02709486|141599391|SUPERIORITY||Least Square Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.19||0.0019|TWO_SIDED|95.0|-0.96|-0.22|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.22|-0.96|0.0019
71007845|NCT00808132|141524112|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.97||||0.308|TWO_SIDED|95.0|-5.76|1.82|||ANCOVA|||Sleep problem index II: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.82|-5.76|0.308
71007846|NCT00808132|141524112|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.48||||0.19|TWO_SIDED|95.0|-6.2|1.23|||ANCOVA|||Sleep problem index II: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.23|-6.20|0.190
71007847|NCT00808132|141524112|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.55|TWO_SIDED|95.0|-0.32|0.17|||ANCOVA|||Sleep quantity: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||0.17|-0.32|0.550
71007848|NCT00808132|141524112|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.477|TWO_SIDED|95.0|-0.15|0.32|||ANCOVA|||Sleep quantity: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||0.32|-0.15|0.477
71007849|NCT00808132|141524114|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||Vasomotor function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||<0.001
71007850|NCT00808132|141524114|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||Vasomotor function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||<0.001
71007851|NCT00808132|141524114|SUPERIORITY_OR_OTHER|||||||0.68|||||||ANCOVA|||Psychosocial function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||0.680
71007852|NCT00808132|141524114|SUPERIORITY_OR_OTHER|||||||0.493|||||||ANCOVA|||Psychosocial function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||0.493
71007853|NCT00808132|141524114|SUPERIORITY_OR_OTHER|||||||0.698|||||||ANCOVA|||Physical function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||0.698
71045337|NCT02709486|141599393|SUPERIORITY||Least Square Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.99|-0.39|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.39|-0.99|<.0001
71102436|NCT01287208|141713045|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
71007854|NCT00808132|141524114|SUPERIORITY_OR_OTHER|||||||0.055|||||||ANCOVA|||Physical function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||0.055
71007855|NCT00808132|141524114|SUPERIORITY_OR_OTHER|||||||0.428|||||||ANCOVA|||Sexual function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||0.428
71007856|NCT00808132|141524114|SUPERIORITY_OR_OTHER|||||||0.071|||||||ANCOVA|||Sexual function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||0.071
71007857|NCT00808132|141524115|SUPERIORITY_OR_OTHER|||||||0.624|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||0.624
71007858|NCT00808132|141524115|SUPERIORITY_OR_OTHER|||||||0.868|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||0.868
71007859|NCT00808132|141524115|SUPERIORITY_OR_OTHER|||||||0.087|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||0.087
71007860|NCT00808132|141524115|SUPERIORITY_OR_OTHER|||||||0.425|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||0.425
71007861|NCT00808132|141524115|SUPERIORITY_OR_OTHER|||||||0.307|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||0.307
71007862|NCT00808132|141524115|SUPERIORITY_OR_OTHER|||||||0.689|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||0.689
71007863|NCT00808132|141524115|SUPERIORITY_OR_OTHER|||||||0.285|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||0.285
71007864|NCT00808132|141524115|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||1.000
71007865|NCT00808132|141524115|SUPERIORITY_OR_OTHER|||||||0.065|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||0.065
71007866|NCT00808132|141524115|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||0.014
71007867|NCT00808132|141524115|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||1.000
71007868|NCT00808132|141524115|SUPERIORITY_OR_OTHER|||||||0.226|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||0.226
71007869|NCT00808132|141524115|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||1.000
71007870|NCT00808132|141524115|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||< 0.001
71007871|NCT00808132|141524115|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||< 0.001
71007872|NCT00808132|141524115|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||< 0.001
71007873|NCT00808132|141524115|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||< 0.001
71102437|NCT01287208|141713048|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||||||0.59
71007874|NCT00808132|141524115|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||< 0.001
71007875|NCT00808132|141524115|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||< 0.001
71007876|NCT00808132|141524115|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||< 0.001
71045338|NCT02709486|141599393|SUPERIORITY||Least Square Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.15||0.0002|TWO_SIDED|95.0|-0.87|-0.27|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.27|-0.87|0.0002
71045339|NCT02709486|141599393|SUPERIORITY||Least Square Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.29|-0.65|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.65|-1.29|<.0001
71045340|NCT02709486|141599393|SUPERIORITY||Least Square Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.28|-0.65|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.65|-1.28|<.0001
71045341|NCT02709486|141599393|SUPERIORITY||Least Square Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.11|-0.42|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.42|-1.11|<.0001
71045342|NCT02709486|141599393|SUPERIORITY||Least Square Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.35|-0.67|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.67|-1.35|<.0001
71045343|NCT02709486|141599393|SUPERIORITY||Least Square Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.11|-0.39|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.39|-1.11|<.0001
71045344|NCT02709486|141599393|SUPERIORITY||Least Square Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.23|-0.51|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.51|-1.23|<.0001
71045345|NCT02709486|141599393|SUPERIORITY||Least Square Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.19||0.0005|TWO_SIDED|95.0|-1.03|-0.29|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.29|-1.03|0.0005
71045346|NCT02709486|141599393|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.13|-0.4|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.40|-1.13|<.0001
71007877|NCT00808132|141524115|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||< 0.001
71007878|NCT00808132|141524115|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||< 0.001
71007879|NCT00808132|141524115|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||< 0.001
71007880|NCT00808132|141524115|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||< 0.001
70925602|NCT05349500|141344677|SUPERIORITY||Mean Difference (Final Values)|13.4||||0.444|TWO_SIDED|95.0|-21.5|48.2|||Mixed Models Analysis|||||48.2|-21.5|0.444
71007881|NCT00808132|141524115|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||< 0.001
71007882|NCT00808132|141524115|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||< 0.001
71007883|NCT00808132|141524115|SUPERIORITY_OR_OTHER|||||||0.317|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||0.317
71007884|NCT00808132|141524115|SUPERIORITY_OR_OTHER|||||||0.531|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||0.531
71007885|NCT00808132|141524115|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||0.610
71007886|NCT00808132|141524115|SUPERIORITY_OR_OTHER|||||||0.848|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||0.848
71007887|NCT00808132|141524115|SUPERIORITY_OR_OTHER|||||||0.551|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||0.551
71007888|NCT00808132|141524115|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||0.300
71007889|NCT00808132|141524115|SUPERIORITY_OR_OTHER|||||||0.299|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||0.299
71007890|NCT00808132|141524115|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||1.000
71007891|NCT00808132|141524115|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||0.660
71007892|NCT00808132|141524115|SUPERIORITY_OR_OTHER|||||||0.199|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||0.199
71007893|NCT00808132|141524115|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||0.770
71007894|NCT00808132|141524115|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||1.000
71007895|NCT00808132|141524115|SUPERIORITY_OR_OTHER|||||||0.769|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||0.769
71007896|NCT00808132|141524115|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||< 0.001
71045347|NCT02709486|141599393|SUPERIORITY||Least Square Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.2||0.0246|TWO_SIDED|95.0|-0.82|-0.06|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.06|-0.82|0.0246
71007897|NCT00808132|141524115|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||< 0.001
71007898|NCT00808132|141524115|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||< 0.001
71007899|NCT00808132|141524115|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||< 0.001
71007900|NCT00808132|141524115|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||< 0.001
71007901|NCT00808132|141524115|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||< 0.001
71007902|NCT00808132|141524115|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||< 0.001
71007903|NCT00808132|141524115|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||< 0.001
71007904|NCT00808132|141524115|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||< 0.001
71007905|NCT00808132|141524115|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||< 0.001
71007906|NCT00808132|141524115|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||< 0.001
71007907|NCT00808132|141524115|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||< 0.001
71007908|NCT00808132|141524115|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||< 0.001
71007909|NCT01009333|141524123|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Mixed Models Analysis|||||||0.008
71007910|NCT01009333|141524124|SUPERIORITY_OR_OTHER|||||||0.589||95.0|||||Mixed Models Analysis|||||||0.589
71007911|NCT01009333|141524125|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Mixed Models Analysis|||||||0.04
71007912|NCT02074436|141524126|OTHER|||||||0.5|TWO_SIDED|0.001|||||Fisher Exact|||The results are from the first and only interim analysis focusing on the primary endpoint: proportion of patient with major bleeding (Grade 3 and 4) during the study. The interim analysis was performed after 11 patients in each arm were randomized and results were obtained. One-sided fisher's exact test was employed in the analysis. The null hypothesis is the probability of occurring major bleeding is the same for Arm A and Arm B||||0.5
71007913|NCT00247962|141524130|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.99|||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71007914|NCT00247962|141524131|SUPERIORITY_OR_OTHER|||||||0.719|||||||ANCOVA|||baseline||||0.719
71007915|NCT00247962|141524131|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANCOVA|||week 16||||0.010
71007916|NCT01955005|141524132|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||This was a 2x2 comparison using Fisher's exact due to low expected cell count. Fisher's exact p\<0.001||||<0.001
71007917|NCT01955005|141524133|SUPERIORITY_OR_OTHER||Z score|568.5||||0.73|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.73
71007918|NCT01955005|141524134|SUPERIORITY_OR_OTHER||Table Probability|0.0142||||0.02|TWO_SIDED||||||Fisher's Exact|||||||0.02
70925603|NCT05349500|141344678|SUPERIORITY||Mean Difference (Final Values)|9.3||||0.638|TWO_SIDED|95.0|-30.6|49.2|||Mixed Models Analysis|||||49.2|-30.6|0.638
70925604|NCT05349500|141344679|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.688|TWO_SIDED|95.0|-13.4|8.9|||Mixed Models Analysis|||||8.9|-13.4|0.688
71007919|NCT02815982|141524135|SUPERIORITY||Mean Difference (Final Values)|-8.7|||<|0.05|TWO_SIDED|95.0|-14.6|-2.7|||t-test, 2 sided|||||-2.7|-14.6|<.05
71007920|NCT02815982|141524136|SUPERIORITY||Mean Difference (Final Values)|35.6|||<|0.001|TWO_SIDED|95.0|-559.0|630.2||p value was the actual signficance level|t-test, 2 sided|||We compared Post-intervention scores||630.2|-559.0|<.001
71007921|NCT02815982|141524137|SUPERIORITY||Mean Difference (Final Values)|0.47|||<|0.001|TWO_SIDED|95.0|-2.3|3.3||controlling for caregiver BMI at baseline and PCS BMI percentile at baseline|t-test, 2 sided|||We compared Post-intervention BMI||3.3|-2.3|<.001
71007922|NCT02815982|141524138|SUPERIORITY||Mean Difference (Final Values)|-0.12|||<|0.03|TWO_SIDED|95.0|-5.4|5.2||p \< .05 was the threshold|t-test, 2 sided|||We compared Post-intervention scores||5.2|-5.4|<.03
71045348|NCT02709486|141599393|SUPERIORITY||Least Square Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.2||0.0003|TWO_SIDED|95.0|-1.1|-0.33|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.33|-1.10|0.0003
71007923|NCT02815982|141524139|SUPERIORITY||Mean Difference (Final Values)|3.5|||<|0.09|TWO_SIDED|95.0|-4.3|11.3||p \< .05 was threshold|t-test, 2 sided|||||11.3|-4.3|<.09
71045349|NCT02709486|141599396|SUPERIORITY||Least Square Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|2.57||0.6427|TWO_SIDED|95.0|-3.9|6.29|||ANCOVA|||Week 8: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||6.29|-3.90|0.6427
71045350|NCT02709486|141599396|SUPERIORITY||Least Square Mean Difference|-2.09|STANDARD_ERROR_OF_MEAN|2.59||0.4208|TWO_SIDED|95.0|-7.22|3.04|||ANCOVA|||Week 8: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||3.04|-7.22|0.4208
71045351|NCT02709486|141599396|SUPERIORITY||Least Square Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|2.73||0.8204|TWO_SIDED|95.0|-6.03|4.79|||ANCOVA|||Week 16: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||4.79|-6.03|0.8204
71045352|NCT02709486|141599396|SUPERIORITY||Least Square Mean Difference|-4.52|STANDARD_ERROR_OF_MEAN|2.85||0.1157|TWO_SIDED|95.0|-10.16|1.13|||ANCOVA|||Week 16: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||1.13|-10.16|0.1157
71045353|NCT02709486|141599396|SUPERIORITY||Least Square Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|2.41||0.5845|TWO_SIDED|95.0|-6.12|3.47|||ANCOVA|||Week 24: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||3.47|-6.12|0.5845
71045354|NCT02709486|141599396|SUPERIORITY||Least Square Mean Difference|-2.93|STANDARD_ERROR_OF_MEAN|2.54||0.2514|TWO_SIDED|95.0|-7.97|2.11|||ANCOVA|||Week 24: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||2.11|-7.97|0.2514
70925605|NCT05349500|141344680|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.709|TWO_SIDED|95.0|-2.5|1.7|||Mixed Models Analysis|||||1.7|-2.5|0.709
70925606|NCT05349500|141344681|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.089|TWO_SIDED|95.0|-3.3|0.2|||Mixed Models Analysis|||||0.2|-3.3|0.089
70925607|NCT05349500|141344682|SUPERIORITY||Mean Difference (Final Values)|14.9||||0.066|TWO_SIDED|95.0|-1.0|30.8|||Mixed Models Analysis|||||30.8|-1.0|0.066
71007924|NCT02815982|141524140|SUPERIORITY||Mean Difference (Final Values)|-328.6|||<|0.08|TWO_SIDED|95.0|-2868.4|2211.2||p \< .05 threshold,|t-test, 2 sided|||We compared Post-intervention scores||2211.2|-2868.4|<.08
71007925|NCT02815982|141524141|SUPERIORITY||Mean Difference (Final Values)|0.06|||<|0.0001|TWO_SIDED|95.0|0.01|0.11||threshold set at p \< .05|t-test, 2 sided|||We compared Post-intervention scores||.11|.01|<.0001
71007926|NCT02815982|141524142|SUPERIORITY||Mean Difference (Final Values)|-2.85|||<|0.001|TWO_SIDED|95.0|-11.3|5.65||threshold set at p \< .05|t-test, 2 sided|||We compared Post-intervention scores||5.65|-11.3|<.001
71007927|NCT02815982|141524143|SUPERIORITY||Mean Difference (Final Values)|0.01|||<|0.001|TWO_SIDED|95.0|-0.04|0.06||threshold p \< .05|t-test, 2 sided|||We compared Post-intervention scores||.06|-.04|<.001
71007928|NCT02815982|141524144|SUPERIORITY||Mean Difference (Final Values)|-348.9|||<|0.12|TWO_SIDED|95.0|-2762.5|2064.8||p \< .05 was the threshold|t-test, 2 sided|||We compared Post-intervention scores||2064.8|-2762.5|<.12
71007929|NCT00352027|141524171|SUPERIORITY_OR_OTHER_LEGACY|||||||0.997|||||||Cox Model|||The association of age with EFS was compared. P values from Score test were computed for the statistical significance.||||0.9970
71007930|NCT00352027|141524174|SUPERIORITY_OR_OTHER_LEGACY|||||||0.997|||||||Cox Model|||||||0.9970
71007931|NCT00352027|141524206|SUPERIORITY_OR_OTHER_LEGACY|||||||0.265||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.265
71007932|NCT00352027|141524206|SUPERIORITY_OR_OTHER_LEGACY|||||||0.057||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.057
70925608|NCT03640312|141344699|SUPERIORITY||Mean Difference (Net)|-4.78|STANDARD_ERROR_OF_MEAN|2.97||0.114|TWO_SIDED|95.0|-10.74|1.18||Adjusting for baseline systolic blood pressure.|Mixed Models Analysis|Difference in Least Squared Means (LSM). Random participant effect, fixed baseline, study arm, and time effects.||||1.18|-10.74|0.114
70925609|NCT03640312|141344700|SUPERIORITY|Adjusted for baseline systolic blood pressure.|Mean Difference (Net)|-4.78|STANDARD_ERROR_OF_MEAN|2.97||0.114|TWO_SIDED|95.0|-10.74|1.18|||Mixed Models Analysis|||||1.18|-10.74|0.114
70925610|NCT03640312|141344701|SUPERIORITY||Mean Difference (Net)|-4.86|STANDARD_ERROR_OF_MEAN|1.87||0.012|TWO_SIDED|95.0|-8.62|-1.11||Adjusted Least Squares Mean.|Mixed Models Analysis|||Adjusted for baseline diastolic blood pressure.||-1.11|-8.62|0.012
70925611|NCT03640312|141344702|SUPERIORITY||Mean Difference (Net)|-4.86|STANDARD_ERROR_OF_MEAN|1.87||0.012|TWO_SIDED|95.0|-8.62|-1.11|||Mixed Models Analysis|||||-1.11|-8.62|0.012
70925612|NCT03640312|141344703|SUPERIORITY||Odds Ratio (OR)|2.4||||0.077|TWO_SIDED|95.0|0.91|6.35|||Mixed Models Analysis|Generalized Linear Mixed Model (binomial distribution assumption with logit link).||||6.35|0.91|0.077
70925613|NCT03640312|141344704|SUPERIORITY||Odds Ratio (OR)|0.13||||0.003|TWO_SIDED|95.0|0.03|0.48|||Regression, Logistic|||Logistic regression model adjusting for baseline systolic and diastolic blood pressure.||0.48|0.03|0.003
70925614|NCT03640312|141344705|SUPERIORITY||Odds Ratio (OR)|0.8||||0.71|TWO_SIDED|95.0|0.24|2.69|||Mixed Models Analysis|||Generalized linear mixed model adjusting for baseline systolic and diastolic blood pressure. Random participant effects. Fixed baseline systolic, diastolic, study arm, and time effects.||2.69|0.24|0.710
70925615|NCT03640312|141344706|SUPERIORITY||Odds Ratio (OR)|0.64||||0.437|TWO_SIDED|95.0|0.21|1.98|||Regression, Logistic|||Logistic regression model adjusting for baseline systolic and diastolic blood pressure.||1.98|0.21|0.437
70925616|NCT03640312|141344707|SUPERIORITY||Mean Difference (Net)|-3.45|STANDARD_ERROR_OF_MEAN|2.01||0.09|TWO_SIDED|95.0|-7.49|0.59||Adjusted for baseline T score|ANCOVA|||Statistical test for difference in Physical Health T Score||0.59|-7.49|0.09
71007933|NCT00352027|141524206|SUPERIORITY_OR_OTHER_LEGACY|||||||0.079||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.079
70925617|NCT03640312|141344707|SUPERIORITY||Mean Difference (Net)|0.55|STANDARD_ERROR_OF_MEAN|1.88||0.77|TWO_SIDED|95.0|-3.22|4.32||Adjusted for baseline mental health T score|ANCOVA|||Statistical test for difference in Mental Health T Score||4.32|-3.22|0.77
70925618|NCT03640312|141344708|SUPERIORITY||Mean Difference (Net)|-4.78|STANDARD_ERROR_OF_MEAN|2.97||0.114|TWO_SIDED|95.0|-10.74|1.182|||Mixed Models Analysis|||Linear mixed model. Random participant effects. Fixed baseline systolic, study arm, and time effects.||1.182|-10.74|0.114
70925619|NCT03640312|141344709|SUPERIORITY||Risk Difference (RD)|-0.06|STANDARD_ERROR_OF_MEAN|0.04||0.49|TWO_SIDED|95.0|-0.15|0.02|||Fisher Exact|||||0.02|-0.15|0.49
70925620|NCT03640312|141344710|SUPERIORITY||Risk Difference (RD)|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.21|TWO_SIDED|95.0|-0.33|0.03|||Chi-squared|||||0.03|-0.33|0.21
70925621|NCT03640312|141344711|SUPERIORITY||Risk Difference (RD)|-0.17|STANDARD_ERROR_OF_MEAN|0.12||0.18|TWO_SIDED|95.0|-0.41|0.08|||Chi-squared|||||0.08|-0.41|0.18
70925622|NCT03640312|141344712|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.09||0.56|TWO_SIDED|95.0|-0.24|0.13|||Mixed Models Analysis|||||0.13|-0.24|0.56
70925623|NCT03640312|141344713|SUPERIORITY||Mean Difference (Net)|-0.71|STANDARD_ERROR_OF_MEAN|0.45||0.12|TWO_SIDED|95.0|-1.61|0.19||Linear mixed model. Random participant effects. Fixed baseline systolic, study arm, and time effects.|Mixed Models Analysis|||||0.19|-1.61|0.12
70925624|NCT03640312|141344714|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.95||0.94|TWO_SIDED|95.0|-1.84|1.99||Linear mixed model. Random participant effects. Fixed baseline systolic, study arm, and time effects.|Mixed Models Analysis||The model estimated mean differences, adjusted for covariates, will not be equal to the raw mean differences observed.|||1.99|-1.84|0.94
70925625|NCT03640312|141344715|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.55|TWO_SIDED|95.0|-0.07|0.04||Linear mixed model. Random participant effects. Fixed baseline systolic, study arm, and time effects.|Mixed Models Analysis|||||0.04|-0.07|0.55
70925626|NCT06132867|141344731|OTHER|A linear mixed-effects analysis of variance model was used for the analysis. The model included sequence, treatment, and period as fixed effects and participants nested within sequence as a random effect. Geometric mean ratios and 90 percent (%) confidence intervals (CIs) were calculated using the exponentiation of the difference between treatment least square means (LSM) from the analyses on the natural log-transformed of Cmax.|Geometric Mean Ratio (GMR) (%)|92.2|||||TWO_SIDED|90.0|86.98|97.74|||||GMR (%) was calculated as 100\*(Treatment A/Treatment B).|||97.74|86.98|
70925627|NCT06132867|141344732|OTHER|A linear mixed-effects analysis of variance model was used for the analysis. The model included sequence, treatment, and period as fixed effects and participants nested within sequence as a random effect. Geometric mean ratios and 90% CIs were calculated using the exponentiation of the difference between treatment LSM from the analyses on the natural log-transformed of AUClast.|GMR (%)|96.0|||||TWO_SIDED|90.0|88.48|104.16|||||GMR (%) was calculated as 100\*(Treatment A/Treatment B).|||104.16|88.48|
70925628|NCT06132867|141344733|OTHER|A linear mixed-effects analysis of variance model was used for the analysis. The model included sequence, treatment, and period as fixed effects and participants nested within sequence as a random effect. Geometric mean ratios and 90% CIs were calculated using the exponentiation of the difference between treatment LSM from the analyses on the natural log-transformed of AUCinf.|GMR (%)|95.84|||||TWO_SIDED|90.0|88.81|103.42|||||GMR (%) was calculated as 100\*(Treatment A/Treatment B).|||103.42|88.81|
70925629|NCT04323137|141344735|SUPERIORITY|||||||0.0035|||||||Regression, Logistic|||"This analysis compared all groups that were informed they were high risk (High risk only, High risk based on medical records, High risk based on algorithm) to control patients who were not sent a message.~Null hypothesis: informing patients they are high risk for flu and flu-related complications does not increase flu vaccination rate; Alternative hypothesis: informing patients they are high risk for flu and flu-related complications increases flu vaccination rate"||||0.0035
71007934|NCT00352027|141524206|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.025
71045355|NCT02709486|141599396|SUPERIORITY||Least Square Mean Difference|-6.68|STANDARD_ERROR_OF_MEAN|3.67||0.0717|TWO_SIDED|95.0|-13.97|0.6|||ANCOVA|||Week 8: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||0.60|-13.97|0.0717
71045356|NCT02709486|141599396|SUPERIORITY||Least Square Mean Difference|-12.69|STANDARD_ERROR_OF_MEAN|3.74||0.001|TWO_SIDED|95.0|-20.11|-5.26|||ANCOVA|||Week 8: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-5.26|-20.11|0.0010
71045357|NCT02709486|141599396|SUPERIORITY||Least Square Mean Difference|-10.31|STANDARD_ERROR_OF_MEAN|3.8||0.0079|TWO_SIDED|95.0|-17.85|-2.77|||ANCOVA|||Week 16: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-2.77|-17.85|0.0079
71007935|NCT00352027|141524206|SUPERIORITY_OR_OTHER_LEGACY|||||||0.68||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.680
71045358|NCT02709486|141599396|SUPERIORITY||Least Square Mean Difference|-10.56|STANDARD_ERROR_OF_MEAN|4.0||0.0096|TWO_SIDED|95.0|-18.49|-2.63|||ANCOVA|||Week 16: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-2.63|-18.49|0.0096
71045359|NCT02709486|141599396|SUPERIORITY||Least Square Mean Difference|-4.28|STANDARD_ERROR_OF_MEAN|4.37||0.3302|TWO_SIDED|95.0|-12.97|4.41|||ANCOVA|||Week 24: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||4.41|-12.97|0.3302
71045360|NCT02709486|141599396|SUPERIORITY||Least Square Mean Difference|-2.74|STANDARD_ERROR_OF_MEAN|4.54||0.5483|TWO_SIDED|95.0|-11.78|6.3|||ANCOVA|||Week 24: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||6.30|-11.78|0.5483
71045361|NCT02709486|141599396|SUPERIORITY||Least Square Mean Difference|-6.75|STANDARD_ERROR_OF_MEAN|3.79||0.0774|TWO_SIDED|95.0|-14.26|0.76|||ANCOVA|||Week 8: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||0.76|-14.26|0.0774
71007936|NCT00352027|141524207|SUPERIORITY_OR_OTHER_LEGACY|||||||0.563||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.563
71045362|NCT02709486|141599396|SUPERIORITY||Least Square Mean Difference|-12.48|STANDARD_ERROR_OF_MEAN|3.87||0.0017|TWO_SIDED|95.0|-20.15|-4.81|||ANCOVA|||Week 8: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-4.81|-20.15|0.0017
71045363|NCT02709486|141599396|SUPERIORITY||Least Square Mean Difference|-9.41|STANDARD_ERROR_OF_MEAN|3.74||0.0135|TWO_SIDED|95.0|-16.83|-1.99|||ANCOVA|||Week 16: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-1.99|-16.83|0.0135
71045364|NCT02709486|141599396|SUPERIORITY||Least Square Mean Difference|-10.04|STANDARD_ERROR_OF_MEAN|3.97||0.0129|TWO_SIDED|95.0|-17.91|-2.17|||ANCOVA|||Week 16: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-2.17|-17.91|0.0129
71045365|NCT02709486|141599396|SUPERIORITY||Least Square Mean Difference|-3.85|STANDARD_ERROR_OF_MEAN|4.43||0.3869|TWO_SIDED|95.0|-12.66|4.96|||ANCOVA|||Week 24: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||4.96|-12.66|0.3869
71102438|NCT01299961|141713050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.4|STANDARD_DEVIATION|13.1|<|0.01|TWO_SIDED||||||t-test, 2 sided|||Most involved side: Synovitis (S), tenosynovitis (T), and power Doppler (PD) of wrist (dorsal (D), palmar (P), and ulnar (U)); S and T of MCP 2,3 (P, plus D for T); PD of the MCP joints (P and D); S and PD of PIP 2, 3 (P, plus D for PD); S and PD for MTP 2, 4 (D). S and PD graded from 0 to 3, and max individual scores are 27 and 39, respectively. T graded on 0-1 scale; max T score is 5. High score is worse. The 7-joint US score is sum of T, S, and PD scores. Change calculated baseline- month 12.||||<0.01
71007937|NCT00352027|141524207|SUPERIORITY_OR_OTHER_LEGACY|||||||0.563||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.563
71007938|NCT00352027|141524207|SUPERIORITY_OR_OTHER_LEGACY|||||||0.563||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.563
71007939|NCT00352027|141524207|SUPERIORITY_OR_OTHER_LEGACY|||||||0.184||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.184
70925630|NCT04323137|141344735|SUPERIORITY|||||||0.613||||||The p-value reported is uncorrected, but the Holm method was used to determine whether the p-value reached statistical significance.|Regression, Logistic|||Null hypothesis: the High risk only and High risk based on medical records messages are equally effective at promoting ﬂu vaccinations; Alternative hypothesis: there is a difference in effectiveness between High risk only and High risk based on medical records. Separate regressions were run to assess pairwise differences between the high-risk arms (analyses 2, 3, and 4). The Holm method was used to test whether each comparison reached significance.||||.613
70925631|NCT04323137|141344735|SUPERIORITY|||||||0.889||||||The p-value reported is uncorrected, but the Holm method was used to determine whether the p-value reached statistical significance.|Regression, Logistic|||Null hypothesis: the High risk only and High risk based on algorithm messages are equally effective at promoting ﬂu vaccinations; Alternative hypothesis: there is a difference in effectiveness between High risk only and High risk based on algorithm messages. Separate regressions were run to assess pairwise differences between the high-risk arms (analyses 2, 3, and 4). The Holm method was used to test whether each comparison reached significance.||||0.889
71045366|NCT02709486|141599396|SUPERIORITY||Least Square Mean Difference|-2.11|STANDARD_ERROR_OF_MEAN|4.62||0.6485|TWO_SIDED|95.0|-11.31|7.08|||ANCOVA|||Week 24: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||7.08|-11.31|0.6485
70925632|NCT04323137|141344735|SUPERIORITY|||||||0.714||||||The p-value reported is uncorrected, but the Holm method was used to determine whether the p-value reached statistical significance.|Regression, Logistic|||Null hypothesis: the High risk based on medical records and High risk based on algorithm messages are equally effective at promoting ﬂu vaccinations; Alternative hypothesis: there is a difference in effectiveness between High risk based on medical records and High risk based on algorithm messages. Separate regressions were run to assess pairwise differences between the high-risk arms (analyses 2, 3, and 4). The Holm method was used to test whether each comparison reached significance.||||.714
71045367|NCT02709486|141599396|SUPERIORITY||Least Square Mean Difference|-6.18|STANDARD_ERROR_OF_MEAN|1.61||0.0001|TWO_SIDED|95.0|-9.34|-3.03|||ANCOVA|||Week 8: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-3.03|-9.34|0.0001
71102439|NCT01299961|141713051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|3.7|<|0.01|TWO_SIDED||||||t-test, 2 sided|||7 joints were scanned by power doppler ultra sound of the most affected side: wrist, MCP 2/3, PIP 2/3, and MTP 2/5. PDUS was scored semi-quantitatively on a scale of 0-3 (higher score is worse). The mean score of the 2-3 views obtained for each joint was added across all 7 joints, and the total PDUS (range 0-21) scores were calculated. The change from baseline to 12 months is calculated as the baseline PDUS minus 12 month PDUS.||||<0.01
71102440|NCT01299961|141713052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_DEVIATION|3.7||0.19|TWO_SIDED||||||t-test, 2 sided|||7 joints were scanned by grey-scale ultra sound of the most affected side: wrist, MCP 2/3, PIP 2/3, and MTP 2/5. GSUS was scored semi-quantitatively on a scale of 0-3 (higher score is worse). The mean score of the 2-3 views obtained for each joint was added across all 7 joints, and the total GSUS (range 0-21) scores were calculated. The change from baseline to 12 months is calculated as the baseline GSUS minus 12 month GSUS.||||0.19
70925633|NCT04323137|141344736|SUPERIORITY|||||||0.181||||||This p-value is from the same regression as the top 10% risk vs. top 3% risk contrast (analysis 2).|Regression, Logistic|||"This analysis tested whether vaccination differed in patients with the same risk level who were sent messages with a vague verbal (high risk) vs. specific numeric (top 10%) risk framing.~This analysis was limited to those informed they were high risk (High risk only, High risk based on medical records, High risk based on algorithm)."||||.181
70925634|NCT04323137|141344736|SUPERIORITY|||||||0.301||||||This p-value is from the same regression as the high risk vs. top 10% risk contrast (analysis 1).|Regression, Logistic|||"This analysis tested whether vaccination differed in patients with the same numeric risk phrasing are differentially affected due to different specific risk levels (3% vs. 10%).~This analysis was limited to those informed they were high risk (High risk only, High risk based on medical records, High risk based on algorithm)."||||.301
70925635|NCT04229992|141344799|SUPERIORITY||||||<|0.05|||||||Regression, Linear|P value was calculated using general linear mode adjusted for age, sex, BMI and baseline level||"1. GG genotype and magnesium treatment vs GG genotype and placebo;~2. GA/AA genotype and magnesium treatment vs GA/AA genotype and Placebo."||||<0.05
70925636|NCT04229992|141344800|SUPERIORITY||||||<|0.05|||||||Regression, Linear|P value was calculated using general linear mode adjusted for age, sex, BMI and baseline level||"1. GG genotype and magnesium treatment vs GG genotype and placebo;~2. GA/AA genotype and magnesium treatment vs GA/AA genotype and Placebo"||||<0.05
70925637|NCT05178316|141344801|SUPERIORITY||Least squares mean difference|0.31|STANDARD_ERROR_OF_MEAN|2.175|=|0.8862|TWO_SIDED|95.0|-3.98|4.6|||Mixed Models Analysis|||||4.60|-3.98|=0.8862
70925638|NCT05178316|141344801|SUPERIORITY||Least squares mean difference|-0.74|STANDARD_ERROR_OF_MEAN|1.817|=|0.6832|TWO_SIDED|95.0|-4.32|2.84|||Mixed Models Analysis|||||2.84|-4.32|=0.6832
70925639|NCT05178316|141344802|SUPERIORITY||Least squares mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.204|=|0.4522|TWO_SIDED|95.0|-0.55|0.25|||Mixed Models Analysis|||||0.25|-0.55|=0.4522
70925640|NCT05178316|141344802|SUPERIORITY||Least squares mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.169|=|0.2032|TWO_SIDED|95.0|-0.55|0.12|||Mixed Models Analysis|||||0.12|-0.55|=0.2032
71045368|NCT02709486|141599396|SUPERIORITY||Least Square Mean Difference|-9.13|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001|TWO_SIDED|95.0|-12.26|-6.0|||ANCOVA|||Week 8: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-6.00|-12.26|<.0001
71045369|NCT02709486|141599396|SUPERIORITY||Least Square Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.79||0.0008|TWO_SIDED|95.0|-9.51|-2.5|||ANCOVA|||Week 16: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-2.50|-9.51|0.0008
70925641|NCT05178316|141344803|SUPERIORITY||Least squares mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.165|=|0.717|TWO_SIDED|95.0|-0.38|0.26|||Mixed Models Analysis|||||0.26|-0.38|=0.7170
70925642|NCT05178316|141344803|SUPERIORITY||Least squares mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.137|=|0.2423|TWO_SIDED|95.0|-0.43|0.11|||Mixed Models Analysis|||||0.11|-0.43|=0.2423
70925643|NCT04873401|141344804|SUPERIORITY||Odds Ratio (OR)|1.05|STANDARD_ERROR_OF_MEAN|0.49||0.928|TWO_SIDED|95.0|0.39|2.79|||Regression, Logistic|||||2.79|0.39|0.928
70925644|NCT04873401|141344805|SUPERIORITY||Median Difference (Final Values)|-0.173|STANDARD_ERROR_OF_MEAN|0.147||0.24|TWO_SIDED|95.0|-0.24|0.115|||Regression, Linear|||||0.115|-0.24|0.240
70925645|NCT04873401|141344806|SUPERIORITY||Slope|0.1171|STANDARD_ERROR_OF_MEAN|0.062||0.367|TWO_SIDED|95.0|0.05|0.29|||Regression, Linear|||||0.29|0.05|0.367
70925646|NCT04873401|141344807|SUPERIORITY||Slope|0.171|STANDARD_ERROR_OF_MEAN|0.062||0.005|TWO_SIDED|95.0|0.05|0.29|||Regression, Linear|||||0.29|0.05|0.005
70925647|NCT03457142|141344812|OTHER|No formal test, a confidence interval estimate for the grade 3+ treatment related AE rate.|grade 3+ treatment related AE rate|0.33|||||TWO_SIDED|90.0|0.17|0.54||||||||0.54|0.17|
70925648|NCT03770273|141344817|OTHER|||||||0.774|||||||Regression, Linear|||||||0.7740
70925649|NCT03770273|141344819|OTHER|||||||0.1071|||||||Regression, Linear|||||||0.1071
70925650|NCT03770273|141344820|OTHER|||||||0.4904|||||||Regression, Linear|||||||0.4904
70925651|NCT03770273|141344821|OTHER|||||||0.1399|||||||Regression, Linear|||||||0.1399
70925652|NCT02921230|141344852|SUPERIORITY|||||||0.0077|||||||Chi-squared|||||||0.0077
70925653|NCT03064217|141344894|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70925654|NCT01084876|141344895|EQUIVALENCE|The therapeutic equivalence between CT-P6 and Herceptin is concluded if the 95% confidence interval (CI) for the risk difference (CT-P6 - Herceptin) estimate in ORR ITRC review during the Main Study Treatment Period is entirely within the predefined equivalence margin of -0.15 to 0.15.|Risk Difference (RD)|-0.0535|||||TWO_SIDED|95.0|-0.143|0.036||||||||0.036|-0.143|
70925655|NCT02100813|141344930|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.31|||<|0.001|TWO_SIDED|95.0|0.23|0.42|||Negative binomial regression|||Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||0.42|0.23|<0.001
70925656|NCT02100813|141344930|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.25|||<|0.001|TWO_SIDED|95.0|0.18|0.33|||Negative binomial regression|||Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||0.33|0.18|<0.001
70925657|NCT02100813|141344930|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.79|||=|0.096|TWO_SIDED|95.0|0.59|1.04|||Negative binomial regression|||Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||1.04|0.59|=0.096
70925658|NCT02100813|141344931|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|7.02|||=|0.007|TWO_SIDED|95.0|1.53|124.0|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||124|1.53|=0.007
70925659|NCT02100813|141344931|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|8.82|||=|0.001|TWO_SIDED|95.0|1.99|154.5|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||154.5|1.99|=0.001
70925660|NCT02100813|141344931|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|1.26|||=|0.43|TWO_SIDED|95.0|0.72|2.31|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||2.31|0.72|=0.43
70925661|NCT02100813|141344932|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|8.73|||<|0.001|TWO_SIDED|95.0|2.93|51.66|||Log binomial regression|||||51.66|2.93|<0.001
70925662|NCT02100813|141344932|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|9.55|||<|0.001|TWO_SIDED|95.0|3.22|56.4|||Log binomial regression|||||56.4|3.22|<0.001
70925663|NCT02100813|141344932|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|1.09|||=|0.55|TWO_SIDED|95.0|0.81|1.49|||Log binomial regression|||||1.49|0.81|=0.55
70925664|NCT04359108|141344935|OTHER|||||||0.02|||||||ANOVA|||Navigate to Destination Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||0.02
70925665|NCT04359108|141344935|OTHER|||||||0.22|||||||t-test, 2 sided|||Navigate to Destination Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performance||||0.22
70925666|NCT04359108|141344935|OTHER|||||||0.017|||||||t-test, 2 sided|||Navigate to Destination Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.017
70925667|NCT04359108|141344935|OTHER|||||||0.98|||||||t-test, 2 sided|||Navigate to Destination Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.98
70925668|NCT04359108|141344935|OTHER|||||||0.014|||||||t-test, 2 sided|||Navigate to Destination Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performance||||0.014
70925669|NCT04359108|141344935|OTHER||||||<|0.001|||||||ANOVA|||Obstacle Avoidance Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||<0.001
70925670|NCT04359108|141344935|OTHER||||||<|0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performance||||<0.01
70925671|NCT04359108|141344935|OTHER|||||||0.156|||||||t-test, 2 sided|||Obstacle Avoidance Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.156
70925672|NCT04359108|141344935|OTHER|||||||0.541|||||||t-test, 2 sided|||Obstacle Avoidance Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.541
70925673|NCT04359108|141344935|OTHER||||||<|0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performance||||<0.01
71007940|NCT00352027|141524207|SUPERIORITY_OR_OTHER_LEGACY|||||||0.563||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.563
71007941|NCT00352027|141524208|SUPERIORITY_OR_OTHER_LEGACY|||||||0.319||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.319
71007942|NCT00352027|141524208|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.010
70925674|NCT04359108|141344935|OTHER|||||||||||||||||Obstacle Avoidance Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -0.10"|||
70925675|NCT04359108|141344935|OTHER|||||||||||||||||Obstacle Avoidance Test - Depth Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 1.00"|||
70925676|NCT04359108|141344935|OTHER|||||||||||||||||Obstacle Avoidance Test - Depth Vision + Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 0.88"|||
70925677|NCT04359108|141344935|OTHER|||||||||||||||||Obstacle Avoidance Test - Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -1.6"|||
70925678|NCT04359108|141344935|OTHER|||||||||||||||||Navigate to Destination Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = N/A \*~\* N/A for Argus Vision test because subject did not successfully reach intended destination for any trial using this mode."|||
70925679|NCT04359108|141344935|OTHER|||||||||||||||||Navigate to Destination Test - Depth Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -1.10"|||
70925680|NCT04359108|141344935|OTHER|||||||||||||||||Navigate to Destination Test - Depth Vision + Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 0.45"|||
70925681|NCT04359108|141344935|OTHER|||||||||||||||||Navigate to Destination Test - Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 1.02"|||
70925682|NCT04359108|141344936|OTHER|||||||0.3|||||||ANOVA|||Navigate to Destination Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||0.30
71007943|NCT00352027|141524208|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.002
71007944|NCT00352027|141524208|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.015
71007945|NCT00352027|141524208|SUPERIORITY_OR_OTHER_LEGACY|||||||0.588||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.588
71007946|NCT00352027|141524209|SUPERIORITY_OR_OTHER_LEGACY|||||||0.071||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.071
70925683|NCT04359108|141344936|OTHER||||||<|0.001|||||||ANOVA|||Obstacle Avoidance Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||<0.001
70925684|NCT04359108|141344936|OTHER||||||<|0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performance||||<0.01
70925685|NCT04359108|141344936|OTHER|||||||0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.01
71007947|NCT00352027|141524209|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||<0.001
71007948|NCT00352027|141524209|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||<0.001
71007949|NCT00352027|141524209|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||<0.001
71007950|NCT00352027|141524209|SUPERIORITY_OR_OTHER_LEGACY|||||||0.707||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.707
71007951|NCT00352027|141524210|SUPERIORITY_OR_OTHER_LEGACY|||||||0.042||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.042
71007952|NCT00352027|141524210|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.025
71102441|NCT02904096|141713053|NON_INFERIORITY|Estimates for PA, PB, and PA-PB were reported together with one-sided 95% confidence interval (CI) for PA-PB constructed via the Farrington-Manning likelihood method. Here PA and PB are the percentage of subjects in Group A and B (Non-inferiority margin = 12%).|Difference in percentage|1.5|||||ONE_SIDED|95.0||3.35||||||||3.35||
70925686|NCT04359108|141344936|OTHER|||||||0.93|||||||t-test, 2 sided|||Obstacle Avoidance Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.93
70925687|NCT04359108|141344936|OTHER||||||<|0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performance||||<0.01
70925688|NCT04359108|141344936|OTHER|||||||||||||||||Obstacle Avoidance Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -0.27"|||
70925689|NCT04359108|141344936|OTHER|||||||||||||||||Obstacle Avoidance Test - Depth Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 1.00"|||
70925690|NCT04359108|141344936|OTHER|||||||||||||||||Obstacle Avoidance Test - Depth Vision + Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 2.75"|||
70925691|NCT04359108|141344936|OTHER|||||||||||||||||Obstacle Avoidance Test - Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 0.60"|||
70925692|NCT04359108|141344936|OTHER|||||||||||||||||Navigate to Destination Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = N/A\*~\* N/A for Argus Vision test because subject did not successfully reach intended destination for any trial using this mode."|||
70925693|NCT04359108|141344936|OTHER|||||||||||||||||Navigate to Destination Test - Depth Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -0.72"|||
70925694|NCT04359108|141344936|OTHER|||||||||||||||||Navigate to Destination Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 2.47"|||
70925695|NCT04359108|141344936|OTHER|||||||||||||||||Navigate to Destination Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 3.81"|||
70925696|NCT04359108|141344937|OTHER||||||<|0.001|||||||ANOVA|navigation system mode and test block as factors||Navigate to Destination Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||<0.001
70925697|NCT04359108|141344937|OTHER||||||<|0.01|||||||t-test, 2 sided|within-participant, 2 sided t-test||Navigate to Destination Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performance||||<0.01
70925698|NCT04359108|141344937|OTHER|||||||0.037||||||within-participant, 2 sided t-test|t-test, 2 sided|||Navigate to Destination Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.037
70925699|NCT04359108|141344937|OTHER|||||||0.34|||||||t-test, 2 sided|within-participant, 2 sided t-test||Navigate to Destination Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.34
70925700|NCT04359108|141344937|OTHER|||||||0.1|||||||t-test, 2 sided|within-participant, 2 sided t-test||Navigate to Destination Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performance||||0.10
70925701|NCT04359108|141344937|OTHER||||||<|0.001|||||||ANOVA|||Obstacle Avoidance Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||<0.001
71102442|NCT02904096|141713054|OTHER||Difference in Percentage|1.5|||||ONE_SIDED|95.0||3.35||||||||3.35||
71102443|NCT02904096|141713055|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Flexion (Left Hand)-baseline and Group A: Flexion (Left Hand)-change from baseline at Month 24.||||<.001
70925702|NCT04359108|141344937|OTHER||||||<|0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performance||||<0.01
71102444|NCT02904096|141713055|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Flexion (Right Hand)-baseline and Group A: Flexion (Right Hand)-change from baseline at Month 24.||||<.001
71007953|NCT00352027|141524210|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.013
71007954|NCT00352027|141524210|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.027
71007955|NCT00352027|141524210|SUPERIORITY_OR_OTHER_LEGACY|||||||0.243||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.243
71007956|NCT00352027|141524211|SUPERIORITY_OR_OTHER_LEGACY|||||||0.546||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.546
71007957|NCT00352027|141524211|SUPERIORITY_OR_OTHER_LEGACY|||||||0.242||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.242
71007958|NCT00352027|141524211|SUPERIORITY_OR_OTHER_LEGACY|||||||0.372||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.372
71007959|NCT00352027|141524211|SUPERIORITY_OR_OTHER_LEGACY|||||||0.503||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.503
71007960|NCT00352027|141524211|SUPERIORITY_OR_OTHER_LEGACY|||||||0.372||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.372
71007961|NCT00352027|141524212|SUPERIORITY_OR_OTHER_LEGACY|||||||0.558||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.558
71007962|NCT00352027|141524212|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.039
71007963|NCT00352027|141524212|SUPERIORITY_OR_OTHER_LEGACY|||||||0.162||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.162
71007964|NCT00352027|141524212|SUPERIORITY_OR_OTHER_LEGACY|||||||0.162||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.162
71007965|NCT00352027|141524213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.381||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.381
71007966|NCT00352027|141524213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.006
71007967|NCT00352027|141524213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.277||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.277
71007968|NCT00352027|141524213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.134||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.134
71007969|NCT00352027|141524214|SUPERIORITY_OR_OTHER_LEGACY|||||||0.629||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.629
71007970|NCT00352027|141524214|SUPERIORITY_OR_OTHER_LEGACY|||||||0.629||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.629
71007971|NCT00352027|141524214|SUPERIORITY_OR_OTHER_LEGACY|||||||0.629||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.629
71007972|NCT00352027|141524214|SUPERIORITY_OR_OTHER_LEGACY|||||||0.858||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.858
71007973|NCT00352027|141524215|SUPERIORITY_OR_OTHER_LEGACY|||||||0.744||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.744
71007974|NCT00352027|141524215|SUPERIORITY_OR_OTHER_LEGACY|||||||0.075||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.075
71007975|NCT00352027|141524215|SUPERIORITY_OR_OTHER_LEGACY|||||||0.512||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.512
71007976|NCT00352027|141524215|SUPERIORITY_OR_OTHER_LEGACY|||||||0.088||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.088
71007977|NCT00352027|141524216|SUPERIORITY_OR_OTHER_LEGACY|||||||0.078||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.078
71007978|NCT00352027|141524216|SUPERIORITY_OR_OTHER_LEGACY|||||||0.041||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.041
71007979|NCT00352027|141524216|SUPERIORITY_OR_OTHER_LEGACY|||||||0.078||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.078
71007980|NCT00352027|141524216|SUPERIORITY_OR_OTHER_LEGACY|||||||0.078||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.078
71007981|NCT00352027|141524217|SUPERIORITY_OR_OTHER_LEGACY|||||||0.739||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.739
71007982|NCT00352027|141524217|SUPERIORITY_OR_OTHER_LEGACY|||||||0.739||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.739
71007983|NCT00352027|141524217|SUPERIORITY_OR_OTHER_LEGACY|||||||0.739||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.739
71102445|NCT02904096|141713055|OTHER|||||||0.054|||||||t-test, 1 sided|||Comparison between Group B: Flexion (Left Hand)-baseline and Group B: Flexion (Left Hand)-change from baseline at Month 24.||||.054
71102446|NCT02904096|141713055|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Flexion (Right Hand)-baseline and Group B: Flexion (Right Hand)-change from baseline at Month 24.||||<.001
71007984|NCT00352027|141524217|SUPERIORITY_OR_OTHER_LEGACY|||||||0.739||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.739
71007985|NCT00352027|141524218|SUPERIORITY_OR_OTHER_LEGACY|||||||0.933||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.933
71007986|NCT00352027|141524218|SUPERIORITY_OR_OTHER_LEGACY|||||||0.933||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.933
71007987|NCT00352027|141524218|SUPERIORITY_OR_OTHER_LEGACY|||||||0.051||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.051
71007988|NCT00352027|141524218|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0779||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.0779
71007989|NCT00352027|141524219|SUPERIORITY_OR_OTHER_LEGACY|||||||0.415||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.415
71007990|NCT00352027|141524219|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.005
71007991|NCT00352027|141524219|SUPERIORITY_OR_OTHER_LEGACY|||||||0.245||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.245
71007992|NCT00352027|141524219|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.005
71007993|NCT00352027|141524220|SUPERIORITY_OR_OTHER_LEGACY|||||||0.814||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.814
71007994|NCT00352027|141524220|SUPERIORITY_OR_OTHER_LEGACY|||||||0.553||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.553
71007995|NCT00352027|141524220|SUPERIORITY_OR_OTHER_LEGACY|||||||0.173||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.173
71007996|NCT00352027|141524220|SUPERIORITY_OR_OTHER_LEGACY|||||||0.122||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.122
71007997|NCT00352027|141524221|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
71007998|NCT00352027|141524222|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generallized Estimating Equations (GEE)|||||||<0.001
71007999|NCT00352027|141524223|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generallized Estimating Equations (GEE)|||||||<0.001
71008000|NCT00352027|141524224|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generallized Estimating Equations (GEE)|||||||<0.001
71008001|NCT00352027|141524225|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generallized Estimating Equations (GEE)|||||||<0.001
71008002|NCT00352027|141524226|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generallized Estimating Equations (GEE)|||||||<0.001
71008003|NCT00352027|141524227|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
71008004|NCT00352027|141524228|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
71008005|NCT00352027|141524229|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
71008006|NCT00352027|141524230|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Generalized Estimating Equations (GEE)|||||||0.005
71008007|NCT00352027|141524231|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
71008008|NCT00352027|141524232|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
71008009|NCT00352027|141524233|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
71008010|NCT00352027|141524234|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
71008011|NCT00352027|141524235|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
71102447|NCT02904096|141713055|OTHER|||||||0.049|||||||t-test, 1 sided|||Comparison between Group A: Extension (Left Hand)-baseline and Group A: Extension (Left Hand)-change from baseline at Month 24.||||.049
71102448|NCT02904096|141713055|OTHER|||||||0.003|||||||t-test, 1 sided|||Comparison between Group A: Extension (Right Hand)-baseline and Group A: Extension (Right Hand)-change from baseline at Month 24.||||.003
71102449|NCT02904096|141713055|OTHER|||||||0.781|||||||t-test, 1 sided|||Comparison between Group B: Extension (Left Hand)-baseline and Group B: Extension (Left Hand)-change from baseline at Month 24.||||.781
71102450|NCT02904096|141713055|OTHER|||||||0.573|||||||t-test, 1 sided|||Comparison between Group B: Extension (Right Hand)-baseline and Group B: Extension (Right Hand)-change from baseline at Month 24.||||.573
71008012|NCT00352027|141524236|SUPERIORITY_OR_OTHER_LEGACY|||||||0.908|||||||Log Rank|||||||0.908
71008013|NCT00352027|141524237|SUPERIORITY_OR_OTHER_LEGACY|||||||0.178|||||||Log Rank|||||||0.178
71008014|NCT00352027|141524238|SUPERIORITY_OR_OTHER_LEGACY|||||||0.411|||||||Log Rank|||||||0.411
71008015|NCT00352027|141524240|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4318|||||||Cox Model|||||||0.4318
71008016|NCT00352027|141524241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2199|||||||Cox Model|||||||0.2199
71008017|NCT00352027|141524242|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8946|||||||Cox Model|||||||0.8946
71008018|NCT00702949|141524247|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||t-test, 2 sided|||Comparing the median numerical change from baseline on hot flash score for Pregabalin 150 Mg with the Placebo.||||0.007
71008019|NCT00702949|141524250|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||Comparing the median numerical change from baseline on hot flash score for Pregabalin 75 Mg with the Placebo.||||0.002
71102451|NCT02904096|141713056|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: (Left Hand)-baseline and Group A: (Left Hand)-change from baseline at Month 24.||||<.001
70925703|NCT04359108|141344937|OTHER|||||||0.67|||||||t-test, 2 sided|||Obstacle Avoidance Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.67
70925704|NCT04359108|141344937|OTHER|||||||0.23|||||||t-test, 2 sided|||Obstacle Avoidance Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.23
70925705|NCT04359108|141344937|OTHER||||||<|0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performance||||<0.01
70925706|NCT04359108|141344937|OTHER|||||||||||||||||Obstacle Avoidance Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -0.79"|||
70925707|NCT04359108|141344937|OTHER|||||||||||||||||Obstacle Avoidance Test - Depth Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 1.38"|||
71008020|NCT00702949|141524251|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||t-test, 2 sided|||Comparing the median percent change from baseline on hot flash score for Pregabalin 75 Mg with the Placebo.||||0.009
71008021|NCT00702949|141524253|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||t-test, 2 sided|||Comparing the median percent change from baseline on hot flash score for Pregabalin 150 Mg with the Placebo.||||0.007
71008022|NCT00598585|141524255|SUPERIORITY|unpaired test, the threshold for statistical significance was p= 0.05|||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
71008023|NCT00135694|141524259|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-13.0|||||TWO_SIDED|90.0|-35.0|10.0||||||||10|-35|
71008024|NCT00135694|141524265|SUPERIORITY_OR_OTHER|||||||0.0183|||||||ANCOVA|Adjusted for immunosuppression dose the subject was receiving at the time of randomization.||||||0.0183
71008025|NCT00135694|141524266|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Adjusted for immunosuppression dose the subject was receiving at the time of randomization.||||||<0.0001
71008026|NCT00852761|141524272|SUPERIORITY_OR_OTHER|||||||0.7298||95.0||||This is the result for the Day 3 analysis.|Chi-squared|||||||0.7298
71102452|NCT02904096|141713056|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: (Right Hand)-baseline and Group A: (Right Hand)-change from baseline at Month 24.||||<.001
71008027|NCT00852761|141524272|SUPERIORITY_OR_OTHER|||||||1||||||This is the result for the Day 8 analysis.|Chi-squared|||||||1.0000
71008028|NCT00852761|141524273|SUPERIORITY_OR_OTHER|||||||0.7298||95.0||||This is the result for the Day 3 analysis.|Chi-squared|||||||0.7298
71102453|NCT02904096|141713056|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: (Left Hand)-baseline and Group B: (Left Hand)-change from baseline at Month 24.||||<.001
71102454|NCT02904096|141713056|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: (Right Hand)-baseline and Group B: (Right Hand)-change from baseline at Month 24.||||<.001
71102455|NCT02904096|141713057|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: (Left Hand)-baseline and Group A: (Left Hand)-change from baseline at Month 24.||||<.001
71102456|NCT02904096|141713057|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: (Right Hand)-baseline and Group A: (Right Hand)-change from baseline at Month 24.||||<.001
70925708|NCT04359108|141344937|OTHER|||||||||||||||||Obstacle Avoidance Test - Depth Vision + Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 2.24"|||
70925709|NCT04359108|141344937|OTHER|||||||||||||||||Obstacle Avoidance Test - Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -0.85"|||
71008029|NCT00852761|141524273|SUPERIORITY_OR_OTHER|||||||0.006||||||This is the result for the Day 8 analysis.|Chi-squared|||||||0.0060
71008030|NCT00852761|141524273|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||This is the result for the Day 15 analysis.|Chi-squared|||||||0.0060
71008031|NCT00852761|141524274|SUPERIORITY_OR_OTHER|||||||0.0332||||||Data apply to Day 15.|Chi-squared|||||||0.0332
71008032|NCT00852761|141524276|SUPERIORITY_OR_OTHER|||||||0.3101||95.0||||This is the result for the Day 3 analysis.|Chi-squared|||||||0.3101
71008033|NCT00852761|141524276|SUPERIORITY_OR_OTHER|||||||0.7242||95.0||||This is the result for the Day 8 analysis.|Chi-squared|||||||0.7242
71008034|NCT00852761|141524276|SUPERIORITY_OR_OTHER|||||||0.0135||||||This is the p value for day 15|Chi-squared|||||||0.0135
71008035|NCT00852761|141524278|SUPERIORITY_OR_OTHER|||||||0.1449||||||P value at day 15.|Chi-squared|||||||0.1449
71008036|NCT00852761|141524278|SUPERIORITY_OR_OTHER|||||||0.1634||||||P value at day 3.|Chi-squared|||||||0.1634
71008037|NCT00852761|141524278|SUPERIORITY_OR_OTHER|||||||0.5454||||||P value at day 8.|Chi-squared|||||||0.5454
71008038|NCT00852761|141524279|SUPERIORITY_OR_OTHER|||||||0.6715||||||This is the p value for day 15.|Chi-squared|||||||0.6715
71008039|NCT00852761|141524279|SUPERIORITY_OR_OTHER|||||||0.7242||||||This is the p value for day 8.|Chi-squared|||||||0.7242
71008040|NCT00852761|141524279|SUPERIORITY_OR_OTHER|||||||0.6715||||||This is the p value for day 3.|Chi-squared|||||||0.6715
71008041|NCT00852761|141524280|SUPERIORITY_OR_OTHER|||||||0.4858||||||P value on day 8.|Chi-squared|||||||0.4858
71008042|NCT00852761|141524280|SUPERIORITY_OR_OTHER|||||||0.3001||||||P value on day 15.|Chi-squared|||||||0.3001
71102457|NCT02904096|141713057|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: (Left Hand)-baseline and Group B: (Left Hand)-change from baseline at Month 24.||||<.001
70925710|NCT04359108|141344937|OTHER|||||||||||||||||Navigate to Destination Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = N/A\*~\* N/A for Argus Vision test because subject did not successfully reach intended destination for any trial using this mode."|||
71008043|NCT02607735|141524296|SUPERIORITY|The SVR12 rate for the SOF/VEL/VOX group was compared to the performance goal of 85% using a 2-sided exact 1-sample binomial test at the 0.05 significance level.|||||<|0.001|||||||2-sided exact 1-sample binomial test|||||||<0.001
71008044|NCT04111185|141524311|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71008045|NCT00877890|141524319|NON_INFERIORITY_OR_EQUIVALENCE|The choice of a 0.4% noninferiority margin was resulted from the considerations of expected clinical benefit of BYETTA in this study based on clinical data evaluating exenatide once weekly and BYETTA, regulatory guidance, published literature, and statistical considerations.|Least Squares Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.138|<|0.0001|TWO_SIDED|95.0|-0.94|-0.39|||ANOVA|Analysis of variance (ANOVA) model includes treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors.||Superiority of exenatide once weekly to BYETTA if the upper limit of the 2-sided 95% CI for treatment difference (exenatide once weekly minus BYETTA) is \<0; noninferiority if this upper limit is \<0.4%. Power: Assuming 15% dropout rate with 206 subjects will complete the study. This sample size would provide 90% power for non-inferiority test with assumption of greater reduction (0.1%) in exenatide once weekly and a common standard deviation of 1.1%.||-0.39|-0.94|<.0001
71008046|NCT00877890|141524320|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Multiplicity adjustment using Hochberg procedure for the 3 key secondary endpoints (i.e., percent to achieving HbA1c goal of \<7%, change in fasting glucose, and percent of achieving fasting plasma glucose goal of \<=126 mg/dL) was performed.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target value of \<7% at Week 24 were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which baseline HbA1c stratum (\<9% or \>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.||||<.0001
71008047|NCT00877890|141524321|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target values of \<=6.5% at Week 24 were compared between treatments using a CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.||||<.0001
71008048|NCT00877890|141524322|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-20.4|STANDARD_ERROR_OF_MEAN|5.57||0.0006|TWO_SIDED|95.0|-31.4|-9.5||Multiplicity adjustment using Hochberg procedure for the 3 key secondary endpoints (i.e., percent to achieving HbA1c goal of \<7%, change in fasting glucose, and percent of achieving fasting plasma glucose goal of \<=126 mg/dL) was performed.|ANCOVA|||Analysis: Change in fasting plasma glucose from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the fasting plasma glucose as a covariate. Null hypothesis: no difference between treatments in change from baseline fasting plasma glucose. Power: based on the primary measurement.||-9.5|-31.4|0.0006
71008049|NCT00877890|141524323|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED|||||Multiplicity adjustment using Hochberg procedure for the 3 key secondary endpoints (i.e., percent to achieving HbA1c goal of \<7%, change in fasting glucose, and percent of achieving fasting plasma glucose goal of \<=126 mg/dL) was performed.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving fasting plasma glucose target of \<=126 mg/dL at Week 24 were compared between treatments using a CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving fasting plasma glucose target. Power: based on the primary measurement.||||0.0008
71102458|NCT02904096|141713057|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: (Right Hand)-baseline and Group B: (Right Hand)-change from baseline at Month 24.||||<.001
71102459|NCT02904096|141713058|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand grip strength (Left Hand)-baseline and Group A: Hand grip strength (Left Hand)-change from baseline at Month 24.||||<.001
71102460|NCT02904096|141713058|OTHER|||||||0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand grip strength (Right Hand)-baseline and Group A: Hand grip strength (Right Hand)-change from baseline at Month 24.||||.001
71102461|NCT02904096|141713058|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Hand grip strength (Left Hand)-baseline and Group B: Hand grip strength (Left Hand)-change from baseline at Month 24.||||<.001
71102462|NCT02904096|141713058|OTHER|||||||0.002|||||||t-test, 1 sided|||Comparison between Group B: Hand grip strength (Right Hand)-baseline and Group B: Hand grip strength (Right Hand)-change from baseline at Month 24.||||.002
71102463|NCT02904096|141713058|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand tip pinch strength (Left Hand)-baseline and Group A: Hand tip pinch strength (Left Hand)-change from baseline at Month 24.||||<.001
71102464|NCT02904096|141713058|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand tip pinch strength (Right Hand)-baseline and Group A: Hand tip pinch strength (Right Hand)-change from baseline at Month 24.||||<.001
71102465|NCT02904096|141713058|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Hand tip pinch strength (Left Hand)-baseline and Group B: Hand tip pinch strength (Left Hand)-change from baseline at Month 24.||||<.001
71102466|NCT02904096|141713058|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Hand tip pinch strength (Right Hand)-baseline and Group B: Hand tip pinch strength (Right Hand)-change from baseline at Month 24.||||<.001
71102467|NCT02904096|141713058|OTHER|||||||0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand key pinch strength (Left Hand)-baseline and Group A: Hand key pinch strength (Left Hand)-change from baseline at Month 24.||||.001
71008050|NCT00877890|141524324|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.487||0.0514|TWO_SIDED|95.0|-1.91|0.01|||ANCOVA|||Analysis: Change in body weight from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the body weight as a covariate. Null hypothesis: no difference between treatments in change from baseline body weight. Power: based on the primary measurement.||0.01|-1.91|0.0514
71008051|NCT00877890|141524325|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|1.5||0.2367|TWO_SIDED|95.0|-4.7|1.2|||ANCOVA|||Analysis: Change in systolic blood pressure from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the systolic blood pressure as a covariate. Null hypothesis: no difference between treatments in change from baseline systolic blood pressure. Power: based on the primary measurement.||1.2|-4.7|0.2367
71008052|NCT00877890|141524326|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.98||0.7717|TWO_SIDED|95.0|-1.7|2.2|||ANCOVA|||Analysis: Change in diastolic blood pressure from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the diastolic blood pressure as a covariate. Null hypothesis: no difference between treatments in change from baseline diastolic blood pressure. Power: based on the primary measurement.||2.2|-1.7|0.7717
71008053|NCT00877890|141524327|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|3.5|<|0.0001|TWO_SIDED|95.0|-22.9|-9.1|||ANCOVA|||Analysis: Change in total cholesterol from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the total cholesterol as a covariate. Null hypothesis: no difference between treatments in change from baseline total cholesterol. Power: based on the primary measurement.||-9.1|-22.9|<.0001
71008054|NCT00877890|141524328|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.8||0.1251|TWO_SIDED|95.0|-2.8|0.3|||ANCOVA|||Analysis: Change in HDL from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the HDL as a covariate. Null hypothesis: no difference between treatments in change from baseline HDL. Power: based on the primary measurement.||0.3|-2.8|0.1251
71008055|NCT00877890|141524329|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|0.95|STANDARD_ERROR_OF_MEAN|0.043||0.2558|TWO_SIDED|95.0|0.87|1.04|||ANCOVA|||Analysis: Triglycerides data were logarithm-transformed and the change at Week 30 to baseline (Day 1) , expressed as the ratio, was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the triglycerides as a covariate. Null hypothesis: no difference between treatments in change from baseline triglycerides. Power: based on the primary measurement.||1.04|0.87|0.2558
71008056|NCT00742391|141524332|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
71102468|NCT02904096|141713058|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand key pinch strength (Right Hand)-baseline and Group A: Hand key pinch strength (Right Hand)-change from baseline at Month 24.||||<.001
71102469|NCT02904096|141713058|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Hand key pinch strength (Left Hand)-baseline and Group B: Hand key pinch strength (Left Hand)-change from baseline at Month 24.||||<.001
71008057|NCT00742391|141524333|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||0.0001
71008058|NCT00394654|141524410|SUPERIORITY_OR_OTHER|||||||0.168|||||||Univariate 2-sample t-test|||||||0.168
71008059|NCT00394654|141524411|SUPERIORITY_OR_OTHER|||||||0.254|||||||Univariate 2-sample t-test|||||||0.254
71008060|NCT00394654|141524412|SUPERIORITY_OR_OTHER|||||||0.677|||||||Univariate 2-sample t-test|||||||0.677
71008061|NCT00394654|141524413|SUPERIORITY_OR_OTHER|||||||0.318|||||||Univariate 2-sample t-test|||||||0.318
71008062|NCT00394654|141524414|SUPERIORITY_OR_OTHER|||||||0.798|||||||Univariate 2-sample t-test|||||||0.798
71008063|NCT00394654|141524415|SUPERIORITY_OR_OTHER|||||||0.766|||||||Univariate 2-sample t-test|||||||0.766
71008064|NCT03756285|141524443|SUPERIORITY||Least Square Means Ratio|0.25|||<|0.001|TWO_SIDED|95.0|0.12|0.52|||Mixed Models Analysis|Covariates: atrial fibrillation status at randomization, baseline value, treatment, visit, and treatment\*visit.||||0.52|0.12|<0.001
71008065|NCT03756285|141524444|SUPERIORITY||Least Square Means Ratio|0.97||||0.568|ONE_SIDED|95.0|0.74||||ANCOVA|Covariates: atrial fibrillation status at randomization, baseline value, treatment|||||0.74|0.568
71008066|NCT03756285|141524445|SUPERIORITY||Mean Difference (Final Values)|21.8||||0.407|TWO_SIDED|95.0|-30.5|74.1|||Mixed Models Analysis|Covariates: atrial fibrillation status at randomization, baseline value, treatment, visit, and treatment\*visit.||||74.1|-30.5|0.407
71008067|NCT02705755|141524462|SUPERIORITY||Least Squares Mean Difference|-4.4||||0.0399|TWO_SIDED|95.0|-8.57|-0.23||P-values were reported without multiplicity adjustment.|Repeated-measures Mixed-effect Model|||Least squares mean differences were calculated based on a repeated-measures mixed-effect model with change from baseline at different time points as the dependent variable, the treatment group (TD-9855 or placebo), time point, baseline and the interaction between the treatment group and time point as fixed factors. A compound symmetry was used as the variance-covariance structure.||-0.23|-8.57|0.0399
71008068|NCT01021293|141524473|NON_INFERIORITY|Non-inferiority of Poliorix™ vaccine as compared to OPV vaccine in terms of the immune response to poliovirus type 1 one month after the third vaccine dose. Non-inferiority in terms of immunogenicity to poliovirus antigens was demonstrated if the upper limit of the 95% confidence interval (CI) on the group difference \[Control Group minus Poliorix Group\] in the percentage of seroprotected subjects|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-1.28|1.24||||||Non-inferiority of Poliorix™ as compared to OPV||1.24|-1.28|
71102470|NCT02904096|141713058|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Hand key pinch strength (Right Hand)-baseline and Group B: Hand key pinch strength (Right Hand)-change from baseline at Month 24.||||<.001
71102471|NCT02904096|141713058|OTHER|||||||0.01|||||||t-test, 1 sided|||Comparison between Group A: Hand palmar pinch strength (Left Hand)-baseline and Group A: Hand palmar pinch strength (Left Hand)-change from baseline at Month 24.||||.010
71102472|NCT02904096|141713058|OTHER|||||||0.06|||||||t-test, 1 sided|||Comparison between Group A: Hand palmar pinch strength (Right Hand)-baseline and Group A: Hand palmar pinch strength (Right Hand)-change from baseline at Month 24.||||.060
71102473|NCT02904096|141713058|OTHER|||||||0.177|||||||t-test, 1 sided|||Comparison between Group B: Hand palmar pinch strength (Left Hand)-baseline and Group B: Hand palmar pinch strength (Left Hand)-change from baseline at Month 24.||||.177
71102474|NCT02904096|141713058|OTHER|||||||0.177|||||||t-test, 1 sided|||Comparison between Group B: Hand palmar pinch strength (Right Hand)-baseline and Group B: Hand palmar pinch strength (Right Hand)-change from baseline at Month 24.||||.177
71008069|NCT01021293|141524473|NON_INFERIORITY|Non-inferiority of Poliorix™ vaccine as compared to OPV vaccine in terms of the immune response to poliovirus type 2 one month after the third vaccine dose. Non-inferiority in terms of immunogenicity to poliovirus antigens was demonstrated if the upper limit of the 95% confidence interval (CI) on the group difference \[Control Group minus Poliorix Group\] in the percentage of seroprotected subjects|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-1.28|1.24||||||Non-inferiority of Poliorix™ as compared to OPV||1.24|-1.28|
71008070|NCT01021293|141524473|NON_INFERIORITY|Non-inferiority of Poliorix™ vaccine as compared to OPV vaccine in terms of the immune response to poliovirus type 3 one month after the third vaccine dose. Non-inferiority in terms of immunogenicity to poliovirus antigens was demonstrated if the upper limit of the 95% confidence interval (CI) on the group difference \[Control Group minus Poliorix Group\] in the percentage of seroprotected subjects|Difference in seroprotection rate|-1.69|||||TWO_SIDED|95.0|-3.9|-0.44||||||Non-inferiority of Poliorix™ as compared to OPV||-0.44|-3.9|
71008071|NCT01084096|141524480|SUPERIORITY|Trial powered to detect a 30% reduction in 28-d NM among \<5th %tile for birth weight infants. We used an intention-to-treat approach, with a model-based adaptation of the permutation test. We fitted an individual-level linear model with 28-d NM by site and randomization strata, nested within site, and computed the residual for each individual and mean cluster-level residuals. Next, we used an ANOVA model to test for trt differences between mean residuals for intervention and control clusters.|Risk Ratio (RR)|0.96||||0.65|TWO_SIDED|95.0|0.87|1.06|||t-test, 2 sided|Cluster-level with 62 degrees of freedom \[101 clusters-37 strata-2 treatment groups\].|Calculated from generalized linear models accounting for the cluster-level variance and adjusted for randomization strata. Each stratum corresponds to 2-4 clusters within the site with equal distribution to treatment and control arms.|||1.06|0.87|0.65
71008072|NCT01084096|141524481|SUPERIORITY||Risk Difference (RD)|0.3546|||<|0.0001|TWO_SIDED|95.0|0.3299|0.3792|||Cochran-Mantel-Haenszel|P-values were calculated from Cochran-Mantel-Haenszel test controlling for randomization strata.|Risk difference represents risk in the intervention clusters minus the risk in the control clusters.|The trial was powered to detect a 30% reduction in 28-day neonatal mortality among infants born at less than the 5th percentile of birth weight, based on previous research and an expected increase from 10% to 50% in the use of antenatal corticosteroids among women at risk of preterm birth in the intervention group.||0.3792|0.3299|<0.0001
71008073|NCT01084096|141524482|OTHER|Descriptive analysis.|Odds Ratio (OR)|1.45|||<|0.0001|TWO_SIDED|95.0|1.33|1.58||P-values were calculated from Cochran-Mantel-Haenszel test controlling for randomization strata.|Cochran-Mantel-Haenszel|||||1.58|1.33|<0.0001
71008074|NCT01084096|141524484|SUPERIORITY||Risk Ratio (RR)|1.12||||0.0127|TWO_SIDED|95.0|1.02|1.22||P-value calculated from a generalized linear model with generalized estimating equations to estimate parameters while controlling for cluster correlations. Model-generated p value was adjusted for randomization strata.|Generalized linear model with GEE||Relative risk calculated from a generalized linear model with generalized estimating equations to estimate parameters while controlling for cluster correlations. Model-generated measure of risk was adjusted for randomization strata.|||1.22|1.02|0.0127
71008075|NCT01084096|141524485|OTHER|Descriptive analysis.|Risk Ratio (RR)|1.11||||0.0181|TWO_SIDED|95.0|1.02|1.22||P-value calculated from a generalized linear model with generalized estimating equations to estimate parameters while controlling for cluster correlations. Model-generated p value was adjusted for randomization strata.|Generalized linear model with GEE||Relative risk calculated from a generalized linear model with generalized estimating equations to estimate parameters while controlling for cluster correlations. Model-generated measure of risk was adjusted for randomization strata.|||1.22|1.02|0.0181
71102475|NCT04003389|141713089|SUPERIORITY||LSMean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.0604|TWO_SIDED|95.0|-0.36|0.21||LSM, SE, CI, \& p-values come from an analysis of covariance (ANCOVA) model with change from baseline at Week 52 timepoint as response, treatment \& smoking status (current vs former/never) as fixed effects with baseline weight \& baseline as covariate.|ANCOVA|||LSMeans (LSM), standard errors (SE), confidence intervals (CI)||0.21|-0.36|0.0604
71102476|NCT04003389|141713089|SUPERIORITY||LSMean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.239|TWO_SIDED|95.0|-0.45|0.11||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||||0.11|-0.45|0.239
71102477|NCT04003389|141713091|SUPERIORITY||LSMean difference|0.007|STANDARD_ERROR_OF_MEAN|0.003||0.029|TWO_SIDED|95.0|0.001|0.014||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femoral Neck)||0.014|0.001|0.029
71102478|NCT04003389|141713091|SUPERIORITY||LSMean difference|0.001|STANDARD_ERROR_OF_MEAN|0.003||0.867|TWO_SIDED|95.0|-0.006|0.007||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femoral Neck)||0.007|-0.006|0.867
71102479|NCT04003389|141713091|SUPERIORITY||LSMean difference|0.006|STANDARD_ERROR_OF_MEAN|0.003||0.027|TWO_SIDED|95.0|0.001|0.012||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femur)||0.012|0.001|0.027
71102480|NCT04003389|141713091|SUPERIORITY||LSMean difference|0.002|STANDARD_ERROR_OF_MEAN|0.003||0.41|TWO_SIDED|95.0|-0.003|0.008||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femur)||0.008|-0.003|0.410
71045370|NCT02709486|141599396|SUPERIORITY||Least Square Mean Difference|-6.97|STANDARD_ERROR_OF_MEAN|1.77|<|0.0001|TWO_SIDED|95.0|-10.44|-3.51|||ANCOVA|||Week 16: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-3.51|-10.44|<.0001
71045371|NCT02709486|141599396|SUPERIORITY||Least Square Mean Difference|-3.08|STANDARD_ERROR_OF_MEAN|1.87||0.1004|TWO_SIDED|95.0|-6.76|0.6|||ANCOVA|||Week 24: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||0.60|-6.76|0.1004
71045372|NCT02709486|141599396|SUPERIORITY||Least Square Mean Difference|-4.94|STANDARD_ERROR_OF_MEAN|1.86||0.0079|TWO_SIDED|95.0|-8.59|-1.3|||ANCOVA|||Week 24: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect||-1.30|-8.59|0.0079
71045373|NCT02709486|141599411|SUPERIORITY||Odds Ratio (OR)|0.1||||0.0027|TWO_SIDED|95.0|0.02|0.46|||Regression, Logistic|||Logistic regression model included baseline diary average pain, baseline WOMAC pain score, classification variables index joint, highest Kellgren-Lawrence grade and treatment. Odds ratio and 95% CI estimated from logistic regression model.||0.46|0.02|0.0027
71045374|NCT02709486|141599411|SUPERIORITY||Odds Ratio (OR)|0.16||||0.0033|TWO_SIDED|95.0|0.05|0.54|||Regression, Logistic|||Logistic regression model included baseline diary average pain, baseline WOMAC pain score, classification variables index joint, highest Kellgren-Lawrence grade and treatment. Odds ratio and 95% CI estimated from logistic regression model.||0.54|0.05|0.0033
71045375|NCT02709486|141599412|SUPERIORITY|||||||0.0002||||||P-value based on the log-rank test.|Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.0002
71045376|NCT02709486|141599412|SUPERIORITY|||||||0.0007||||||P-value based on the log-rank test.|Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.0007
71045377|NCT02709486|141599413|SUPERIORITY||Odds Ratio (OR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.29|0.59|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.59|0.29|<.0001
71045378|NCT02709486|141599413|SUPERIORITY||Odds Ratio (OR)|0.55||||0.001|TWO_SIDED|95.0|0.38|0.78|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.78|0.38|0.0010
71045379|NCT02709486|141599413|SUPERIORITY||Odds Ratio (OR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.36|0.7|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.70|0.36|<.0001
71045380|NCT02709486|141599413|SUPERIORITY||Odds Ratio (OR)|0.62||||0.0067|TWO_SIDED|95.0|0.44|0.88|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.88|0.44|0.0067
71045381|NCT02709486|141599413|SUPERIORITY||Odds Ratio (OR)|0.64||||0.0087|TWO_SIDED|95.0|0.45|0.89|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.89|0.45|0.0087
71102481|NCT04003389|141713091|SUPERIORITY||LSMean difference|0.005|STANDARD_ERROR_OF_MEAN|0.003||0.087||95.0|-0.001|0.011||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Trochanter)||0.011|-0.001|0.087
71045382|NCT02709486|141599413|SUPERIORITY||Odds Ratio (OR)|0.74||||0.0787|TWO_SIDED|95.0|0.53|1.04|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.04|0.53|0.0787
71045383|NCT02709486|141599413|SUPERIORITY||Odds Ratio (OR)|0.65||||0.0129|TWO_SIDED|95.0|0.47|0.91|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.91|0.47|0.0129
71045384|NCT02709486|141599413|SUPERIORITY||Odds Ratio (OR)|0.65||||0.0124|TWO_SIDED|95.0|0.47|0.91|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.91|0.47|0.0124
71045385|NCT02709486|141599413|SUPERIORITY||Odds Ratio (OR)|0.7||||0.0399|TWO_SIDED|95.0|0.5|0.98|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.98|0.50|0.0399
71045386|NCT02709486|141599413|SUPERIORITY||Odds Ratio (OR)|0.62||||0.006|TWO_SIDED|95.0|0.45|0.87|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.87|0.45|0.0060
71008076|NCT01005966|141524525|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.01||||0.2117|TWO_SIDED|95.0|-7.75|1.73||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|Analysis of variance (ANOVA) based on a mixed model with the factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for NaF toothpaste and AmF toothpaste to be equal with respect to enamel remineralization potential.||1.73|-7.75|0.2117
71008077|NCT01005966|141524526|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.96||||0.0002|TWO_SIDED|95.0|4.27|13.66||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel remineralization potential.||13.66|4.27|0.0002
71008078|NCT01005966|141524526|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.57||||0.0557||95.0|-0.11|9.24||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and Na MFP/NaF toothpaste (1450ppmF) to be equal with respect to enamel remineralization potential.||9.24|-0.11|0.0557
71008079|NCT01005966|141524526|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|23.55|||<|0.0001|TWO_SIDED|95.0|18.86|28.24||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel remineralization potential.||28.24|18.86|<0.0001
71008080|NCT01005966|141524526|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.4||||0.0625|TWO_SIDED|95.0|-0.23|9.03||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the Na MFP/NaF toothpaste (1450ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel remineralization potential.||9.03|-0.23|0.0625
71008081|NCT01005966|141524526|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|18.99|||<|0.0001|TWO_SIDED|95.0|14.36|23.61||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the Na MFP/NaF toothpaste (1450ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel remineralization potential.||23.61|14.36|<0.0001
71008082|NCT01005966|141524526|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|14.59|||<|0.0001|TWO_SIDED|95.0|9.95|19.23||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (675ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel remineralization potential.||19.23|9.95|<0.0001
71008083|NCT01005966|141524526|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.58||||0.0017|TWO_SIDED|95.0|2.88|12.27||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the AmF toothpaste (1400ppmF) and Na MFP/NaF toothpaste (1450ppmF) to be equal with respect to enamel remineralization potential.||12.27|2.88|0.0017
71008084|NCT01005966|141524526|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.97|||<|0.0001|TWO_SIDED|95.0|7.31|16.64||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for AmF toothpaste (1400ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel remineralization potential.||16.64|7.31|<0.0001
71008085|NCT01005966|141524526|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|26.56|||<|0.0001|TWO_SIDED|95.0|21.88|31.24||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for AmF toothpaste (1400ppmF) and placebo toothpaste (0ppmF) to be equal with respect to enamel remineralization potential.||31.24|21.88|<0.0001
71008086|NCT01005966|141524527|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|37.24||||0.7912|TWO_SIDED|95.0|-239.62|314.09||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and AmF toothpaste (1400ppmF) to be equal with respect to enamel fluoride uptake potential.||314.09|-239.62|0.7912
71008087|NCT01005966|141524527|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|532.61||||0.0002|TWO_SIDED|95.0|259.06|806.16||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and Na MFP/NaF toothpaste (1450ppmF) to be equal with respect to enamel fluoride uptake potential.||806.16|259.06|0.0002
71008088|NCT01005966|141524527|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|692.91|||<|0.0001|TWO_SIDED|95.0|418.73|967.09||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel fluoride uptake potential.||967.09|418.73|<0.0001
71008089|NCT01005966|141524527|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1879.4|||<|0.0001|TWO_SIDED|95.0|1605.75|2153.04||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel fluoride uptake potential.||2153.04|1605.75|<0.0001
70925711|NCT04359108|141344937|OTHER|||||||||||||||||Navigate to Destination Test - Depth Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 0.18"|||
70925712|NCT04359108|141344937|OTHER|||||||||||||||||Navigate to Destination Test - Depth Vision + Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -0.97"|||
70925713|NCT04359108|141344937|OTHER|||||||||||||||||Navigate to Destination Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -1.23"|||
71008090|NCT01005966|141524527|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|495.38||||0.0005|TWO_SIDED|95.0|221.09|769.66||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for AmF toothpaste (1400ppmF) and Na MFP/ NaF toothpaste (1450ppmF) and to be equal with respect to enamel fluoride uptake potential.||769.66|221.09|0.0005
71008091|NCT01005966|141524527|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|655.67|||<|0.0001|TWO_SIDED|95.0|382.41|928.93||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for AmF toothpaste (1400ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel fluoride uptake potential.||928.93|382.41|<0.0001
71008092|NCT01005966|141524527|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1842.16|||<|0.0001|TWO_SIDED|95.0|1568.73|2115.6||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for AmF toothpaste (1400ppmF) and placebo toothpaste (0ppmF) to be equal with respect to enamel fluoride uptake potential.||2115.60|1568.73|<0.0001
71008093|NCT01005966|141524527|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|160.3||||0.2448|TWO_SIDED|95.0|-110.58|431.18||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the Na MFP/NaF toothpaste (1450ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel fluoride uptake potential.||431.18|-110.58|0.2448
71008094|NCT01005966|141524527|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1346.79|||<|0.0001|TWO_SIDED|95.0|1076.46|1617.11||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the Na MFP/NaF toothpaste (1450ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel fluoride uptake potential.||1617.11|1076.46|<0.0001
71008095|NCT01005966|141524527|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1186.49|||<|0.0001|TWO_SIDED|95.0|915.38|1457.6||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (675ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel fluoride uptake potential.||1457.60|915.38|<0.0001
71008096|NCT01451203|141524528|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann point estimate of shift|0.0|||<|0.001|TWO_SIDED|95.0|0.0|0.0||The ANCOVA on the ranks with treatment as factors and Baseline rank as covariate was used.|ANCOVA|||The mTSS was analyzed using LINEAR for the imputation of missing data at Week 52.The primary Week 52 analysis assessed whether treatment up to Week 52 with the CZP group was superior to the placebo group in mTSS at Week 52. The 2-sided null and alternative hypotheses were: H0: πC = πM Ha: πC ≠ πM where πC represented subjects in the CZP group at Week 52 and πM represented subjects in the placebo group at Week 52.||0.00|0.00|<0.001
71008097|NCT01451203|141524529|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman point estimate of shift|0.0||||0.003|TWO_SIDED|95.0|0.0|0.0|||ANCOVA|The ANCOVA on the ranks with treatment as factors and Baseline rank as covariate was used.||The mTSS was analyzed using LINEAR for the imputation of missing data at Week 24.||0.00|0.00|0.003
71008098|NCT01451203|141524530|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
71008099|NCT01451203|141524531|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
70925714|NCT04359108|141344938|OTHER||||||<|0.001|||||||ANOVA|Single-factor test on navigation system mode||Navigate to Destination Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||<0.001
71102482|NCT04003389|141713091|SUPERIORITY||LSMean difference|0.003|STANDARD_ERROR_OF_MEAN|0.003||0.259||95.0|-0.002|0.009||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Trochanter)||0.009|-0.002|0.259
71102483|NCT04003389|141713092|SUPERIORITY||LSMean difference|0.048|STANDARD_ERROR_OF_MEAN|0.027||0.079|TWO_SIDED|95.0|-0.006|0.102||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femoral Neck)||0.102|-0.006|0.079
71102484|NCT04003389|141713092|SUPERIORITY||LSMean difference|0.001|STANDARD_ERROR_OF_MEAN|0.027||0.98|TWO_SIDED|95.0|-0.052|0.053||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femoral Neck)||0.053|-0.052|0.980
70925715|NCT04359108|141344938|OTHER|||||||0.17|||||||t-test, 2 sided|||Navigate to Destination Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performance||||0.17
71102485|NCT04003389|141713092|SUPERIORITY||LSMean difference|0.048|STANDARD_ERROR_OF_MEAN|0.023||0.042||95.0|0.002|0.094||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femur)||0.094|0.002|0.042
70925716|NCT04359108|141344938|OTHER||||||<|0.01|||||||t-test, 2 sided|||Navigate to Destination Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||<0.01
70925717|NCT04359108|141344938|OTHER|||||||0.33|||||||t-test, 2 sided|||Navigate to Destination Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.33
70925718|NCT04359108|141344938|OTHER||||||<|0.01|||||||t-test, 2 sided|||Navigate to Destination Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performance||||<0.01
70925719|NCT04359108|141344939|OTHER|||||||0.023|||||||ANOVA|2X2 within-participant test with factors of resolution and field-of-view||Significance of Resolution: test for null hypothesis of equivalent performance between low and high resolution vision modes||||0.023
70925720|NCT04359108|141344939|OTHER|||||||0.039|||||||ANOVA|2X2 within-participant test with factors of resolution and field-of-view||Significance of Resolution: test for null hypothesis of equivalent performance between low and high field-of-view vision modes||||0.039
70925721|NCT04359108|141344939|OTHER|||||||0.801|||||||ANOVA|2x2 within-participant test with factors of resolution and field-of-view||Significance of Interaction between Resolution and Field-of-View: test for null hypothesis of no interaction||||.801
70925722|NCT06393088|141344940|SUPERIORITY|It was calculated that 24 participants randomized 1:1 between 2 arms would have at least an 85% power to detect a difference in pain relief of 30 points as measured using a Visual Analog Device. The actual difference in the mean of the change in pain level, as measured using a Visual Analog Scale, between the two independent groups is 41.67. Results of the post trial calculation was a 95.7% power to detect the difference in pain relief using 29 randomized participants.|Mean Difference (Net)|41.67|||<|0.01|TWO_SIDED|95.0|20.15|61.67||The threshold is P-value \<.0.05 for statistical significance A bootstrap N=20,000 was used for all estimates|t-test, 2 sided|||"Null Hypothesis:~There is not a statistically significant difference in nociceptive musculoskeletal pain when using an IR REHAB device when compared with a sham (placebo) device as a therapy in an approved and standardized clinical protocol."||61.67|20.15|<0.01
70925723|NCT02515773|141344941|SUPERIORITY||Mean Difference (Net)|0.08|||<|0.001|TWO_SIDED|||||This is a calculated p-value less than 0.001|ANCOVA|||||||<0.001
70925724|NCT02515773|141344942|SUPERIORITY||Mean Difference (Net)|0.07||||0.044|TWO_SIDED||||||ANCOVA|||||||0.044
70925725|NCT02515773|141344943|SUPERIORITY||Mean Difference (Net)|0.08|||<|0.001|TWO_SIDED|||||This is a calculated p-value less than 0.001|ANCOVA|||||||<0.001
71008100|NCT01451203|141524532|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||Fisher Exact|||||||0.002
71008101|NCT03521089|141524549|SUPERIORITY|||||||0.0039|||||||ANCOVA|||||||0.0039
70925726|NCT02515773|141344944|SUPERIORITY||Mean Difference (Net)|0.09||||0.041|TWO_SIDED||||||ANCOVA|||||||0.041
70925727|NCT04176965|141344945|NON_INFERIORITY|Non-inferiority based on the observed 95% Upper Confidence Limit of the difference in means between the 2 groups (FINEVISION HP - AcrySof SN60AT). Non-inferiority margin = 0.10 logMAR.|Mean difference|0.045|STANDARD_ERROR_OF_MEAN|0.0084|<|0.0001|TWO_SIDED|90.0|0.0316|0.0592|||t-test, 1 sided|||||0.0592|0.0316|<0.0001
70925728|NCT04176965|141344946|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70925729|NCT04176965|141344947|NON_INFERIORITY|Noninferiority of FINEVISION HP compared to control in percentages of first operative eyes with secondary surgical interventions related to the optical properties of the IOL was evaluated using two-sided 90% Farrington method confidence intervals around the difference in percentages between the 2 groups. If the upper limit of the confidence interval is less than 1.4%, the FINEVISION HP IOL will be considered statistically non-inferior to the control IOL.|Difference in percentages|0.3|||||TWO_SIDED|90.0|-0.76|1.36||||||||1.36|-0.76|
70925730|NCT04176965|141344952|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70925731|NCT04176965|141344953|NON_INFERIORITY|Cumulative: Cystoid macular oedema. The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
70925732|NCT04176965|141344953|NON_INFERIORITY|Cumulative: Cystoid macular oedema. The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
71008102|NCT03521089|141524549|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
71102486|NCT04003389|141713092|SUPERIORITY||LSMean difference|0.02|STANDARD_ERROR_OF_MEAN|0.023||0.386||95.0|-0.025|0.065||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femur)||0.065|-0.025|0.386
71102487|NCT04003389|141713092|SUPERIORITY||LSMean difference|0.041|STANDARD_ERROR_OF_MEAN|0.029||0.156||95.0|-0.016|0.099||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Trochanter)||0.099|-0.016|0.156
71102488|NCT04003389|141713092|SUPERIORITY||LSMean difference|0.028|STANDARD_ERROR_OF_MEAN|0.029||0.328|TWO_SIDED|95.0|-0.028|0.084||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Trochanter)||0.084|-0.028|0.328
71102489|NCT04003389|141713093|SUPERIORITY||LSMean difference|0.002|STANDARD_ERROR_OF_MEAN|0.004||0.497||95.0|-0.005|0.009||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||||0.009|-0.005|0.497
71008103|NCT03521089|141524549|SUPERIORITY|||||||0.0156|||||||Wilcoxon (Mann-Whitney)|||||||0.0156
71008104|NCT03521089|141524550|SUPERIORITY|||||||0.9674|||||||ANCOVA|||||||0.9674
71008105|NCT03521089|141524550|SUPERIORITY|||||||0.0938|||||||Wilcoxon (Mann-Whitney)|||||||0.0938
71008106|NCT03521089|141524550|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.2500
71008107|NCT03521089|141524551|SUPERIORITY|||||||0.0067|||||||ANCOVA|||||||0.0067
71008108|NCT03521089|141524551|SUPERIORITY|||||||0.0313|||||||Wilcoxon (Mann-Whitney)|||||||0.0313
71008109|NCT03521089|141524551|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.7500
71008110|NCT03521089|141524552|SUPERIORITY|||||||0.3069|||||||ANCOVA|||||||0.3069
71008111|NCT03521089|141524552|SUPERIORITY|||||||0.1875|||||||Wilcoxon (Mann-Whitney)|||||||0.1875
71008112|NCT03521089|141524552|SUPERIORITY|||||||0.7188|||||||Wilcoxon (Mann-Whitney)|||||||0.7188
71008113|NCT03521089|141524553|SUPERIORITY|||||||0.2609|||||||ANCOVA|||||||0.2609
71008114|NCT03521089|141524553|SUPERIORITY|||||||0.0313|||||||Wilcoxon (Mann-Whitney)|||||||0.0313
71008115|NCT03521089|141524553|SUPERIORITY|||||||0.0156|||||||Wilcoxon (Mann-Whitney)|||||||0.0156
71008116|NCT03521089|141524554|SUPERIORITY|||||||0.6951|||||||ANCOVA|||||||0.6951
71008117|NCT03521089|141524554|SUPERIORITY|||||||0.0938|||||||Wilcoxon (Mann-Whitney)|||||||0.0938
71008118|NCT03521089|141524554|SUPERIORITY|||||||0.0938|||||||Wilcoxon (Mann-Whitney)|||||||0.0938
71008119|NCT03521089|141524555|SUPERIORITY|||||||0.3592|||||||ANCOVA|||||||0.3592
71008120|NCT03521089|141524555|SUPERIORITY|||||||0.0625|||||||Wilcoxon (Mann-Whitney)|||||||0.0625
71008121|NCT03521089|141524555|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0000
71008122|NCT05064449|141524576|OTHER||Geometric Mean Ratio (%)|116.59|||||TWO_SIDED|90.0|91.3|148.9|||||GMR (%) was calculated as 100\*(Soticlestat + Itraconazole / Soticlestat Alone).|Linear mixed-effects model was used for analysis, using fixed-effect (treatment), random-effect (participants). The point estimates and the 90 percent (%) confidence intervals (CIs) for the geometric mean ratio (GMR) of Cmax for soticlestat with versus without itraconazole were calculated by exponentiation of the point estimates of the differences between treatments and the corresponding 90% CIs from the analyses on the ln-transformed Cmax.||148.90|91.30|
71008123|NCT05064449|141524577|OTHER||Geometric Mean Ratio (%)|107.31|||||TWO_SIDED|90.0|88.02|130.83|||||GMR (%) was calculated as 100\*(Soticlestat + Mefenamic Acid / Soticlestat Alone).|Linear mixed-effects model was used for analysis, using fixed-effect (treatment), random-effect (participants). The point estimates and the 90% CIs for the GMR of Cmax for soticlestat with versus without mefenamic acid were calculated by exponentiation of the point estimates of the differences between treatments and the corresponding 90% CIs from the analyses on the ln-transformed Cmax.||130.83|88.02|
71008124|NCT05064449|141524578|OTHER||Geometric Mean Ratio (%)|123.96|||||TWO_SIDED|90.0|106.21|144.68|||||GMR (%) was calculated as 100\*(Soticlestat + Itraconazole / Soticlestat Alone).|Linear mixed-effects model was used for analysis, using fixed-effect (treatment), random-effect (participants). The point estimates and the 90% CIs for the GMR of AUC∞ for soticlestat with versus without itraconazole were calculated by exponentiation of the point estimates of the differences between treatments and the corresponding 90% CIs from the analyses on the ln-transformed AUC∞.||144.68|106.21|
71008125|NCT05064449|141524579|OTHER||Geometric Mean Ratio (%)|100.57|||||TWO_SIDED|90.0|86.17|117.38|||||GMR (%) was calculated as 100\*(Soticlestat + Mefenamic Acid / Soticlestat Alone).|Linear mixed-effects model was used for analysis, using fixed-effect (treatment), random-effect (participants). The point estimates and the 90% CIs for the GMR of AUC∞ for soticlestat with versus without mefenamic acid were calculated by exponentiation of the point estimates of the differences between treatments and the corresponding 90% CIs from the analyses on the ln-transformed AUC∞.||117.38|86.17|
71008126|NCT05064449|141524580|OTHER||Geometric Mean Ratio (%)|121.97|||||TWO_SIDED|90.0|103.47|143.79|||||GMR (%) was calculated as 100\*(Soticlestat + Itraconazole / Soticlestat Alone).|Linear mixed-effects model was used for analysis, using fixed-effect (treatment), random-effect (participants). The point estimates and the 90% CIs for the GMR of AUClast for soticlestat with versus without itraconazole were calculated by exponentiation of the point estimates of the differences between treatments and the corresponding 90% CIs from the analyses on the ln-transformed AUClast.||143.79|103.47|
71008127|NCT05064449|141524581|OTHER||Geometric Mean Ratio (%)|107.38|||||TWO_SIDED|90.0|91.68|125.77|||||GMR (%) was calculated as 100\*(Soticlestat + Mefenamic Acid / Soticlestat Alone).|Linear mixed-effects model was used for analysis, using fixed-effect (treatment), random-effect (participants). The point estimates and the 90% CIs for the GMR of AUClast for soticlestat with versus without mefenamic acid were calculated by exponentiation of the point estimates of the differences between treatments and the corresponding 90% CIs from the analyses on the ln-transformed AUClast.||125.77|91.68|
71045387|NCT02709486|141599413|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9449|TWO_SIDED|95.0|0.72|1.42|||Regression, Logistic|||Week 24: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.42|0.72|0.9449
71045388|NCT02709486|141599413|SUPERIORITY||Odds Ratio (OR)|0.84||||0.3238|TWO_SIDED|95.0|0.6|1.18|||Regression, Logistic|||Week 24: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.18|0.60|0.3238
71045389|NCT02709486|141599415|SUPERIORITY||LS Mean Ratio|0.67|STANDARD_ERROR_OF_MEAN|0.07||0.0001|TWO_SIDED|95.0|0.54|0.82|||Negative binomial model|||Week 2: Least square (LS) Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.82|0.54|0.0001
71008128|NCT05064449|141524582|OTHER||Median Difference (Final Values)|0.003|||=|0.2305|TWO_SIDED|90.0|-0.001|0.126|||Wilcoxon Signed Rank Test||Difference was calculated as (Soticlestat + Itraconazole) - Soticlestat Alone. The difference of medians (treatment effect) and the corresponding 90% CI was estimated using the Hodges-Lehmann method and Walsh Averages.|||0.126|-0.001|=0.2305
71008129|NCT05064449|141524583|OTHER||Median Difference (Final Values)|-0.096|||=|0.583|TWO_SIDED|90.0|-0.128|0.018|||Wilcoxon Signed Rank Test||Difference was calculated as (Soticlestat + Mefenamic Acid) - Soticlestat Alone. The difference of medians (treatment effect) and the corresponding 90% was estimated using the Hodges-Lehmann method and Walsh Averages.|||0.018|-0.128|=0.5830
71045390|NCT02709486|141599415|SUPERIORITY||LS Mean Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.08||0.0067|TWO_SIDED|95.0|0.61|0.92|||Negative binomial model|||Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.92|0.61|0.0067
71045391|NCT02709486|141599415|SUPERIORITY||LS Mean Ratio|0.64|STANDARD_ERROR_OF_MEAN|0.08||0.0003|TWO_SIDED|95.0|0.51|0.82|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.82|0.51|0.0003
71045392|NCT02709486|141599415|SUPERIORITY||LS Mean Ratio|0.74|STANDARD_ERROR_OF_MEAN|0.09||0.0112|TWO_SIDED|95.0|0.58|0.93|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.93|0.58|0.0112
71102490|NCT04003389|141713093|SUPERIORITY||LSMean difference|-0.001|STANDARD_ERROR_OF_MEAN|0.004||0.878||95.0|-0.007|0.006||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||||0.006|-0.007|0.878
71102491|NCT04003389|141713094|SUPERIORITY||LSMean difference|0.02|STANDARD_ERROR_OF_MEAN|0.031||0.527|TWO_SIDED|95.0|-0.042|0.082||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||||0.082|-0.042|0.527
71008130|NCT03812224|141524595|SUPERIORITY||LS Mean Difference|-1.62|||<|0.001||95.0|-2.52|-0.73|||Generalized Linear Mixed Model|||The primary endpoint was analyzed using a generalized linear mixed model which includes treatment, visit, treatment-by-visit interaction, stratification factors of migraine type and prior migraine preventive treatment status, and baseline value as covariates and assumes a first-order auto regression covariance structure.||-0.73|-2.52|<0.001
71102492|NCT04003389|141713094|SUPERIORITY||LSMean difference|-0.005|STANDARD_ERROR_OF_MEAN|0.031||0.872||95.0|-0.066|0.056||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||||0.056|-0.066|0.872
71008131|NCT03812224|141524596|SUPERIORITY||Odds Ratio (OR)|2.33||||0.005|TWO_SIDED|95.0|1.29|4.23|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test, stratified by stratification factors of migraine type and prior migraine preventive treatment status.||||4.23|1.29|0.005
71102493|NCT00835354|141713112|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|89.2||||||90.0|86.2|92.2|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||92.2|86.2|
71102494|NCT00835354|141713113|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|90.5||||||90.0|88.9|92.1|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||92.1|88.9|
71008132|NCT03812224|141524597|SUPERIORITY||LS Mean Difference|-1.47|||<|0.001||95.0|-2.24|-0.71|||Generalized Linear Mixed Model|||Analysis utilizes a generalized linear mixed model which includes treatment, visit, treatment-by-visit interaction, stratification factors of migraine type (episodic migraine or chronic migraine) and prior migraine preventive treatment status (ever used or never used), and baseline value as covariates and assumes a first-order auto regression covariance structure.||-0.71|-2.24|<0.001
71008133|NCT01258738|141524613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.64||||0.0062|TWO_SIDED|95.0|5.36|27.92||P-value \<0.05 was required to declare statistical significance.|Cochran-Mantel-Haenszel|||"The null hypothesis was that the efficacy of etanercept was not different from placebo as measured by the proportion of subjects achieving an ASAS 40 response after 12 weeks of treatment. The alternative hypothesis was that the efficacy of etanercept was different from placebo.~The primary endpoint was tested at 2-sided alpha = 0.05 significance level. Comparative analysis was carried out for Week 12 data only."||27.92|5.36|0.0062
71008134|NCT01258738|141524614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.46||||0.0059|TWO_SIDED|95.0|3.69|19.24|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||19.24|3.69|0.0059
71008135|NCT01258738|141524614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.19||||0.3786|TWO_SIDED|95.0|-4.98|15.35|||Cochran-Mantel-Haenszel|||"Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made.~Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4"||15.35|-4.98|0.3786
71008136|NCT01258738|141524614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.83||||0.0304|TWO_SIDED|95.0|1.79|23.87|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||23.87|1.79|0.0304
71008137|NCT01258738|141524614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.52||||0.0023|TWO_SIDED|95.0|7.29|29.75|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||29.75|7.29|0.0023
71008138|NCT01258738|141524615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.44||||0.0189|TWO_SIDED|95.0|3.2|25.68|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||25.68|3.20|0.0189
71008139|NCT01258738|141524615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.29||||0.0983|TWO_SIDED|95.0|-2.17|22.75|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||22.75|-2.17|0.0983
71008140|NCT01258738|141524615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.61||||0.0867|TWO_SIDED|95.0|-2.63|23.84|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||23.84|-2.63|0.0867
71008141|NCT01258738|141524615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.27||||0.0195|TWO_SIDED|95.0|3.1|29.43|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||29.43|3.10|0.0195
71008142|NCT01258738|141524616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.63|||<|0.0001|TWO_SIDED|95.0|11.85|33.41|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||33.41|11.85|<0.0001
71008143|NCT01258738|141524616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.83||||0.0021|TWO_SIDED|95.0|5.09|20.57|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||20.57|5.09|0.0021
71008144|NCT01258738|141524616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.89||||0.002|TWO_SIDED|95.0|5.18|24.6|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||24.60|5.18|0.0020
71008145|NCT01258738|141524616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.79|||<|0.0001|TWO_SIDED|95.0|10.92|32.67|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||32.67|10.92|<0.0001
71045393|NCT02709486|141599415|SUPERIORITY||LS Mean Ratio|0.72|STANDARD_ERROR_OF_MEAN|0.09||0.0093|TWO_SIDED|95.0|0.56|0.92|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.92|0.56|0.0093
71045394|NCT02709486|141599415|SUPERIORITY||LS Mean Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.09||0.0237|TWO_SIDED|95.0|0.59|0.96|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.96|0.59|0.0237
71045395|NCT02709486|141599415|SUPERIORITY||LS Mean Ratio|0.74|STANDARD_ERROR_OF_MEAN|0.11||0.0374|TWO_SIDED|95.0|0.56|0.98|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.98|0.56|0.0374
71008146|NCT01258738|141524617|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71008147|NCT01258738|141524617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.001|TWO_SIDED|95.0|-0.74|-0.34|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.34|-0.74|<0.001
71008148|NCT01258738|141524617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|||<|0.001|TWO_SIDED|95.0|-0.81|-0.41|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.41|-0.81|<0.001
71008149|NCT01258738|141524617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|||<|0.001|TWO_SIDED|95.0|-0.85|-0.37|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.37|-0.85|<0.001
71008150|NCT01258738|141524618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.84||||0.0209|TWO_SIDED|95.0|2.58|23.09|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||23.09|2.58|0.0209
71008151|NCT01258738|141524618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.65||||0.0179|TWO_SIDED|95.0|1.82|15.48|||Cochran-Mantel-Haenszel|||"Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.~Week 2"||15.48|1.82|0.0179
71102495|NCT00835354|141713114|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|90.7||||||90.0|89.1|92.3|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||92.3|89.1|
71102496|NCT04551053|141713115|SUPERIORITY||Odds Ratio (OR)|1.75||||0.2878|TWO_SIDED|95.0|0.62|4.94||Cochran Mantel-Haenszel test stratified by Dynamic International Prognostic Scoring System (DIPSS) category (intermediate 1 versus intermediate 2 and high) and Baseline platelet count (≥100 × 10\^9/Liters \[L\] versus 50 to \<100 × 10\^9/L inclusive)|Cochran-Mantel-Haenszel|||||4.94|0.62|0.2878
71102497|NCT04551053|141713116|SUPERIORITY||Odds Ratio (OR)|1.34||||0.5349|TWO_SIDED|95.0|0.53|3.39||calculated from Cochran Mantel-Haenszel test stratified by DIPSS category (intermediate 1 versus intermediate 2 and high) and Baseline platelet count (≥100 × 10\^9/L versus 50 to \<100 × 10\^9/L inclusive)|Cochran-Mantel-Haenszel|||||3.39|0.53|0.5349
71102498|NCT04551053|141713118|SUPERIORITY|||||||0.2224||||||calculated from log-rank test stratified by DIPSS category (intermediate 1 versus intermediate 2 and high) and Baseline platelet count (≥100 x 10\^9/L versus 50 to \<100 x 10\^9/L inclusive)|Log Rank|||||||0.2224
71008152|NCT01258738|141524618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.81||||0.0611|TWO_SIDED|95.0|-0.03|13.65|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||13.65|-0.03|0.0611
71008153|NCT01258738|141524618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.73||||0.0141|TWO_SIDED|95.0|3.14|22.32|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||22.32|3.14|0.0141
71008154|NCT01258738|141524618|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71008155|NCT01258738|141524619|SUPERIORITY_OR_OTHER|||||||0.0022|TWO_SIDED||||||Log Rank|||"Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made.~Comparative analysis was carried out for Week 12 data only."||||0.0022
71008156|NCT01258738|141524620|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71008157|NCT01258738|141524620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.0156|TWO_SIDED|95.0|-1.26|-0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.13|-1.26|0.0156
71008158|NCT01258738|141524620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.0111|TWO_SIDED|95.0|-1.06|-0.14|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.14|-1.06|0.0111
71008159|NCT01258738|141524620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.0936|TWO_SIDED|95.0|-0.91|0.07|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.07|-0.91|0.0936
71008160|NCT01258738|141524620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.2678|TWO_SIDED|95.0|-0.81|0.23|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.23|-0.81|0.2678
71008161|NCT01258738|141524621|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results included unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71102499|NCT04101331|141713182|OTHER|||||||0.051||||||One-sided p-value.|Exact binomial test|Exact binomial test compares versus a proportion of 0.25.||||||0.051
71102500|NCT04101331|141713183|OTHER|||||||0.051||||||One-sided p-value.|Exact binomial test|Exact binomial test compares versus a proportion of 0.25.||||||0.051
70925733|NCT04176965|141344953|NON_INFERIORITY|Cumulative: Hypopyon. The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
71008162|NCT01258738|141524621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.0102|TWO_SIDED|95.0|-1.4|-0.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.19|-1.40|0.0102
71008163|NCT01258738|141524621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||0.0007|TWO_SIDED|95.0|-1.44|-0.39|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.39|-1.44|0.0007
71008164|NCT01258738|141524621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.0057|TWO_SIDED|95.0|-1.35|-0.23|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.23|-1.35|0.0057
71008165|NCT01258738|141524621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.0077|TWO_SIDED|95.0|-1.44|-0.22|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.22|-1.44|0.0077
70925734|NCT04176965|141344953|NON_INFERIORITY|Cumulative: Hypopyon. The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
71008166|NCT01258738|141524622|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71008167|NCT01258738|141524622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93||||0.0091|TWO_SIDED|95.0|-1.62|-0.23|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.23|-1.62|0.0091
71008168|NCT01258738|141524622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.0097|TWO_SIDED|95.0|-1.38|-0.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.19|-1.38|0.0097
71008169|NCT01258738|141524622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.0101|TWO_SIDED|95.0|-1.45|-0.2|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.20|-1.45|0.0101
71008170|NCT01258738|141524622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97||||0.0031|TWO_SIDED|95.0|-1.61|-0.33|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.33|-1.61|0.0031
71008171|NCT01258738|141524623|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71008172|NCT01258738|141524623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87||||0.0064|TWO_SIDED|95.0|-1.49|-0.25|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.25|-1.49|0.0064
70925735|NCT04176965|141344953|NON_INFERIORITY|Cumulative: Endophthalmitis. The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
70925736|NCT04176965|141344953|NON_INFERIORITY|Cumulative: Endophthalmitis. The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
70925737|NCT04176965|141344953|NON_INFERIORITY|Cumulative: Lens dislocated from posterior chamber. The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
70925738|NCT04176965|141344953|NON_INFERIORITY|Cumulative: Lens dislocated from posterior chamber. The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
70925739|NCT04176965|141344953|NON_INFERIORITY|Cumulative: Pupillary block.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
70925740|NCT04176965|141344953|NON_INFERIORITY|Cumulative: Pupillary block.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
70925741|NCT04176965|141344953|NON_INFERIORITY|Cumulative: Retinal detachment.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
70925742|NCT04176965|141344953|NON_INFERIORITY|Cumulative: Retinal detachment.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
70925743|NCT04176965|141344953|NON_INFERIORITY|Cumulative: Secondary surgical intervention.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
70925744|NCT04176965|141344953|NON_INFERIORITY|Cumulative: Secondary surgical intervention.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
70925745|NCT04176965|141344953|NON_INFERIORITY|Persistent: Corneal stroma oedema.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
70925746|NCT04176965|141344953|NON_INFERIORITY|Persistent: Corneal stroma oedema.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
70925747|NCT04176965|141344953|NON_INFERIORITY|Persistent: Cystoid macular oedema.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
70925748|NCT04176965|141344953|NON_INFERIORITY|Persistent: Cystoid macular oedema.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
70925749|NCT04176965|141344953|NON_INFERIORITY|Persistent: Iritis.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
70925750|NCT04176965|141344953|NON_INFERIORITY|Persistent: Iritis.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
71008173|NCT01258738|141524623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0407|TWO_SIDED|95.0|-1.12|-0.02|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.02|-1.12|0.0407
70925751|NCT04176965|141344953|NON_INFERIORITY|Persistent: Raised Intraocular Pressure (IOP) requiring treatment.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
70925752|NCT04176965|141344953|NON_INFERIORITY|Persistent: Raised Intraocular Pressure (IOP) requiring treatment.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
70925753|NCT03652688|141344969|SUPERIORITY||F|14.463|||<|0.001|TWO_SIDED||||||ANOVA|||The unit of analyses was the individual, nested within groups.||||<0.001
70925754|NCT03652688|141344970|SUPERIORITY|||||||0.08|||||||Chi-squared, Corrected|||||||.08
70925755|NCT03652688|141344971|SUPERIORITY|||||||0.954|||||||Chi-squared, Corrected|||||||0.954
70925756|NCT03652688|141344972|SUPERIORITY||Chi-Square|4.436||||0.035|TWO_SIDED||||||Chi-squared, Corrected|||||||.035
70925757|NCT03652688|141344973|SUPERIORITY||Chi-Square|2.615||||0.106|TWO_SIDED||||||Chi-squared, Corrected|||||||.106
70925758|NCT03652688|141344974|SUPERIORITY||Chi-Square|11.636|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected|||||||<0.001
70925759|NCT03033576|141344996|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.04|TWO_SIDED|90.0|0.41|0.97||Pre-specified one-sided alpha=0.1|Log Rank|||The statistical design assumed exponential PFS with a median of 3.0 months on the ipilimumab group (null hypothesis). The study was powered to detect a change in median PFS to 6.0 months in the combination therapy group (corresponding to an HR of 0.50). A total of 84 participants (63 randomized to combination group and 21 to ipilimumab group) with 78 events (across both groups) would provide 89% power for a one-sided alpha of 10% using a log-rank test.||0.97|0.41|0.04
70925760|NCT03033576|141344999|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.28|TWO_SIDED|90.0|0.5|1.39|||Log Rank|||||1.39|0.50|0.28
70925761|NCT04749615|141345087|NON_INFERIORITY|Noninferiority Margin = (-Infinity, 1.28)||||||0.11|||||||t-test, 1 sided|||||||0.11
70925762|NCT04749615|141345088|NON_INFERIORITY|a noninferiority margin of 1.0 and 10% attrition|Mean Difference (Final Values)|0.05||||0.5|TWO_SIDED|95.0||||this is the calculated p-value.|t-test, 2 sided|||||||0.5
71008174|NCT01258738|141524623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.0349|TWO_SIDED|95.0|-1.24|-0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.05|-1.24|0.0349
71008175|NCT01258738|141524623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.0021|TWO_SIDED|95.0|-1.65|-0.37|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.37|-1.65|0.0021
71102501|NCT04101331|141713184|OTHER|||||||0.112||||||One-sided p-value.|Exact binomial test|Exact binomial test compares versus a proportion of 0.25.||||||0.112
71102502|NCT04101331|141713186|OTHER|||||||0.537||||||One-sided p-value.|Exact binomial test|Exact binomial test compares versus a proportion of 0.25.||||||0.537
71102503|NCT04378153|141713206|SUPERIORITY||Difference in % Participants|2.17||||0.1215|TWO_SIDED|95.0|-0.7|5.7|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants changing assigned regimen is the same in Discontinue and Continue arms.||5.7|-0.7|0.1215
71102504|NCT00488293|141713207|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||t-test, 2 sided|||||||0.66
71102505|NCT00488293|141713208|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||Chi-squared|||||||0.88
70925770|NCT03736720|141345114|OTHER|No statistical test.|Proportion|0.091|||||TWO_SIDED|80.0|0.033|0.301|||||Estimated using Jeffrey's prior method.|||0.301|0.033|
70925771|NCT03736720|141345120|SUPERIORITY|||||||0.289|||||||Sign test|two-sided test.||Comparing the pre-treatment and end of treatment QoL scores.||||0.289
70925772|NCT03194217|141345126|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.7||0.668|TWO_SIDED|95.0|-1.68|1.08|||ANCOVA|||||1.08|-1.68|0.668
70925773|NCT03194217|141345126|SUPERIORITY||Mean Difference (Final Values)|0.88|STANDARD_ERROR_OF_MEAN|0.7||0.213|TWO_SIDED|95.0|-0.5|2.26|||ANCOVA|||||2.26|-0.50|0.213
70925774|NCT03194217|141345126|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.7||0.575|TWO_SIDED|95.0|-1.76|0.98|||ANCOVA|||||0.98|-1.76|0.575
70925775|NCT04541147|141345151|EQUIVALENCE|Test if the number of doses in Dexamethasone Plus Analgesics group differs from that in Analgesics Alone group at a significance level of 0.05.|Mean Difference (Final Values)|6.9|STANDARD_DEVIATION|10.1||0.16|TWO_SIDED|95.0|-2.9|16.7|||t-test, 2 sided|||||16.7|-2.9|0.16
70925776|NCT04541147|141345152|EQUIVALENCE|Test if the average pain score in Dexamethasone Plus Analgesics group differs from that in Analgesics Alone group at a significance level of 0.05.|Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|1.4||0.56|TWO_SIDED|95.0|-1.8|1.0|||t-test, 2 sided|||||1.0|-1.8|0.56
70925777|NCT04541147|141345153|EQUIVALENCE|Test if the Number of participants with post-operative complications in Dexamethasone Plus Analgesics group differs from that in Analgesics Alone group at a significance level of 0.05.|Risk Difference (RD)|0.07|STANDARD_ERROR_OF_MEAN|0.15||1|TWO_SIDED|95.0|-0.22|0.36|||Fisher Exact|||||0.36|-0.22|1.00
71008176|NCT01258738|141524624|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71008177|NCT01258738|141524624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0164|TWO_SIDED|95.0|-1.04|-0.11|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.11|-1.04|0.0164
71008178|NCT01258738|141524624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.0095|TWO_SIDED|95.0|-0.95|-0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.13|-0.95|0.0095
71008179|NCT01258738|141524624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0127|TWO_SIDED|95.0|-0.99|-0.12|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.12|-0.99|0.0127
71102506|NCT00488293|141713209|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||t-test, 2 sided|||||||0.39
71102507|NCT00488293|141713210|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||t-test, 2 sided|||||||0.22
71102508|NCT00488293|141713211|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||t-test, 2 sided|||||||0.81
71102509|NCT00488293|141713212|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||t-test, 2 sided|||||||0.61
71102510|NCT00488293|141713213|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||t-test, 2 sided|||||||0.36
71102511|NCT00488293|141713214|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||t-test, 2 sided|||||||0.73
70925778|NCT04064164|141345206|EQUIVALENCE|Pearson's Chi-square test was completed between the total instances of diminutives either identified by human or the Elderspeak App.||||||0.004||||||Dear (root word)|Chi-squared|X-squared = 8.4 df=1||||||.004
70925779|NCT04064164|141345206|EQUIVALENCE|Pearson's Chi-square test was completed between the total instances of diminutives either identified by human or the Elderspeak App. Significant associations indicated the human and app were accurately identifying true positives (1:1) or true negatives (0:0).|||||<|0.001||||||Sweet (root word)|Chi-squared|X-squared = 20.20 df=1||||||<.001
70925780|NCT04064164|141345206|EQUIVALENCE|Pearson's Chi-square test was completed between the total instances of diminutives either identified by human or the Elderspeak App.||||||0.02||||||Girl (root word)|Chi-squared|X-squared = 5.08, df=1||||||.02
70925781|NCT04064164|141345206|EQUIVALENCE|Pearson's Chi-square test was completed between the total instances of diminutives either identified by human or the Elderspeak App.||||||0.1||||||Honey (root word)|Chi-squared|X-squared = 2.7, df= 1||||||.10
70925782|NCT04064164|141345206|EQUIVALENCE|Pearson's Chi-square test was completed between the total instances of diminutives either identified by human or the Elderspeak App.||||||0.85||||||Baby (root word)|Chi-squared|X-squared = 12.2, df = 1||||||0.85
71008180|NCT01258738|141524624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0166|TWO_SIDED|95.0|-0.99|-0.1|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.10|-0.99|0.0166
71008181|NCT01258738|141524625|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71102512|NCT00488293|141713215|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||t-test, 2 sided|||||||0.22
71102513|NCT00488293|141713216|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||Chi-squared|||||||0.65
71008182|NCT01258738|141524625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.0029|TWO_SIDED|95.0|-1.28|-0.27|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.27|-1.28|0.0029
70925783|NCT01000961|141345222|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority endpoint of the clinical trial would be achieved if the upper limit of the 95.8% CI of the difference between RP103 and Cystagon® was less than the a-priori 0.3 non-inferiority margin, which would correspond to an observed p-value less than or equal to 0.02104|Mean Difference (Final Values)|0.0785||||0.0001|TWO_SIDED|95.8|0.0107|0.1464|||t-test, 1 sided||95.8% confidence interval was used instead of 95% to take into account a sample size re-estimation calculation that was performed after 20 patients were enrolled.|16-subject study will have 90% power to reject the null hypothesis of non-inferiority at the 0.025 level of significance with a non-inferiority margin of 0.3. Final analysis was performed at a nominal significance level of 0.02104.||0.1464|0.0107|0.0001
70925784|NCT01000961|141345223|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.4|||||TWO_SIDED|95.0|1.17|1.67||||||||1.67|1.17|
71102514|NCT00500331|141713217|OTHER|Tukey's trend test for dose response: Change= Baseline+Treatment|||||<|0.001||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05|ANCOVA|Change= Baseline+Treatment||Placebo, GSK189075 50 mg, GSK189075 100 mg, GSK189075 250 mg, GSK189075 500 mg, GSK189075 1000 mg||||<0.001
70925785|NCT01000961|141345224|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|105.0|||||TWO_SIDED|95.0|90.0|150.0||||||||150|90|
70925786|NCT01000961|141345225|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.03|||||TWO_SIDED|95.0|1.75|2.39||||||||2.39|1.75|
70925787|NCT05480124|141345238|SUPERIORITY|||||||0.609|||||||t-test, 2 sided|||||||0.609
70925788|NCT05480124|141345240|SUPERIORITY|||||||0.098|||||||t-test, 2 sided|||||||0.098
70925789|NCT05480124|141345241|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||||||0.204
71008183|NCT01258738|141524625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67||||0.0147|TWO_SIDED|95.0|-1.21|-0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.13|-1.21|0.0147
71102515|NCT00500331|141713217|OTHER|Tukey's trend test for dose response|||||<|0.001||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05|ANCOVA|||Placebo, GSK189075 50 mg, GSK189075 100 mg, GSK189075 250 mg, GSK189075 500 mg||||<0.001
70925790|NCT05480124|141345242|SUPERIORITY|||||||0.383|||||||t-test, 2 sided|||||||0.383
70925791|NCT05480124|141345243|SUPERIORITY|||||||0.201|||||||t-test, 2 sided|||||||0.201
70925792|NCT04709783|141345249|OTHER|One group pre-post test.|Median Difference (Final Values)|-2.67||||0.01|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.01
70925793|NCT04709783|141345250|OTHER||Median Difference (Final Values)|-2.49||||0.01|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.01
70925794|NCT04709783|141345251|OTHER||Median Difference (Final Values)|-1.84||||0.07|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.07
71008184|NCT01258738|141524625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75||||0.0056|TWO_SIDED|95.0|-1.28|-0.22|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.22|-1.28|0.0056
71008185|NCT01258738|141524625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95||||0.001|TWO_SIDED|95.0|-1.52|-0.39|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.39|-1.52|0.0010
71008186|NCT01258738|141524626|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71102516|NCT00500331|141713217|OTHER|Tukey's trend test for dose response|||||<|0.001||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05|ANCOVA|Change=Baseline+Treatment||Placebo, GSK189075 50 mg, GSK189075 100 mg, GSK189075 250 mg||||<0.001
71102517|NCT00500331|141713217|OTHER|Tukey's trend test for dose response|||||<|0.001||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05|ANCOVA|Change=Baseline+Treatment||Placebo, GSK189075 50 mg, GSK189075 100 mg||||<0.001
71102518|NCT00500331|141713217|OTHER|Tukey's trend test for dose response|||||<|0.001||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05|ANCOVA|Change=Baseline+Treatment||Placebo, GSK189075 50 mg||||<0.001
70925795|NCT04709783|141345252|OTHER||Median Difference (Final Values)|-2.37||||0.02|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.02
70925796|NCT03365882|141345259|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.44|TWO_SIDED|95.0|0.43|1.45|||Log Rank|||||1.45|0.43|0.44
70925797|NCT03365882|141345261|SUPERIORITY|||||||0.17|||||||Log Rank|||||||0.17
70925798|NCT05177848|141345268|OTHER|||||||0.9793||||||"A linear mixed effects model tested the interaction between group and condition on the rate of substitution~Results:~Condition: X2(6) = 4.30, p = 0.64 Group: X2(1) 0.22, p = 0.64 Condition:Group: X2(6) = 1.15, p = 0.98"|Mixed Models Analysis|||||||0.9793
70925799|NCT05177848|141345269|OTHER|||||||0.29||||||"A linear mixed effects model tested the interaction between group and condition on Q0 (derived intensity).~Results:~Condition: X2(6) = 6.59, p = 0.36 Group: X2(1) = 0.07, p = 0.79 Condition:Group: X2(6) = 7.38, p = 0.29"|Mixed Models Analysis|||||||0.29
70925800|NCT05177848|141345269|OTHER|||||||0.46||||||"A linear mixed effects model tested the interaction between group and condition on Alpha (demand elasticity).~Results:~Condition: X2(6) = 0.0001, p = 1.00 Group: X2(1) = 0.00, p = 0.99 Condition:Group: X2(6) = 5.65, p = 0.46"|Mixed Models Analysis|||||||0.46
70925801|NCT04342494|141345275|EQUIVALENCE|Symptom-level change estimates were adjusted for baseline PHQ-9 score via analysis of covariance.||||||0.31|||||||ANCOVA|||||||0.31
70925802|NCT04342494|141345276|EQUIVALENCE|Average mood score obtained from daily measurements analyzed via analysis of variance||||||0.0073|||||||ANOVA|||||||0.0073
70925803|NCT04342494|141345277|EQUIVALENCE|Symptom-level change estimates were adjusted for baseline PANSI-PI score via analysis of covariance||||||0.03|||||||ANCOVA|||||||0.03
70925804|NCT04342494|141345278|EQUIVALENCE|Symptom-level change estimates were adjusted for baseline PANSI-NSI score via analysis of covariance||||||0.71|||||||ANCOVA|||||||0.71
70925805|NCT04342494|141345279|EQUIVALENCE|Symptom-level change estimates were adjusted for baseline GAD-7 score via analysis of covariance||||||0.31|||||||ANCOVA|||||||0.31
70925806|NCT05746494|141345281|OTHER|Omnibus analysis||||||0.023|||||||ANOVA|||||||0.023
70925807|NCT05746494|141345282|OTHER|Omnibus analysis||||||0.042|||||||Multilevel Modeling|||||||0.042
70925808|NCT05746494|141345283|OTHER|Omnibus analysis||||||0.98|||||||t-test, 2 sided|||||||0.980
70925809|NCT05746494|141345284|OTHER|Omnibus analysis||||||0.01|||||||Multilevel Modeling|||||||0.010
70925810|NCT05746494|141345285|OTHER|Omnibus analysis||||||0.064|||||||t-test, 2 sided|||||||0.064
71008187|NCT01258738|141524626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.0173|TWO_SIDED|95.0|-1.19|-0.12|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.12|-1.19|0.0173
71008188|NCT01258738|141524626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.1618|TWO_SIDED|95.0|-0.97|0.16|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.16|-0.97|0.1618
71008189|NCT01258738|141524626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.0153|TWO_SIDED|95.0|-1.25|-0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.13|-1.25|0.0153
71008190|NCT01258738|141524626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0866|TWO_SIDED|95.0|-1.05|0.07|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.07|-1.05|0.0866
71008191|NCT01258738|141524627|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71102519|NCT00500331|141713217|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.73|||<|0.001|TWO_SIDED|95.0|-1.02|-0.44||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. GSK189075 50 mg||-0.44|-1.02|<0.001
71045396|NCT02709486|141599415|SUPERIORITY||LS Mean Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.11||0.0468|TWO_SIDED|95.0|0.57|1.0|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.00|0.57|0.0468
71045397|NCT02709486|141599415|SUPERIORITY||LS Mean Ratio|0.78|STANDARD_ERROR_OF_MEAN|0.11||0.0751|TWO_SIDED|95.0|0.59|1.03|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.03|0.59|0.0751
71102520|NCT00500331|141713217|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64|||<|0.001|TWO_SIDED|95.0|-0.94|-0.35||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. GSK189075 100 mg||-0.35|-0.94|<0.001
71102521|NCT00500331|141713217|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74|||<|0.001|TWO_SIDED|95.0|-1.03|-0.44||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. GSK189075 250 mg||-0.44|-1.03|<0.001
71102522|NCT00500331|141713217|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|||<|0.001|TWO_SIDED|95.0|-1.19|-0.61||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. GSK189075 500 mg||-0.61|-1.19|<0.001
71102523|NCT00500331|141713217|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.07|||<|0.001|TWO_SIDED|95.0|-1.36|-0.77||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. GSK189075 1000 mg||-0.77|-1.36|<0.001
71102524|NCT00500331|141713217|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.76|||<|0.001|TWO_SIDED|95.0|-1.05|-0.47||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. Pioglitazone 30 mg||-0.47|-1.05|<0.001
71102525|NCT03345550|141713240|SUPERIORITY|||||||0.24|||||||Kruskal-Wallis|||Baseline||||.24
71102526|NCT03345550|141713240|SUPERIORITY|||||||0.43|||||||Kruskal-Wallis|||1 month analysis||||.43
71102527|NCT03345550|141713240|SUPERIORITY|||||||0.54|||||||Kruskal-Wallis|||3 month||||.54
71102528|NCT03345550|141713243|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||.31
71102529|NCT01052779|141713288|NON_INFERIORITY|Non-inferiority was concluded if the lower bound of the 95% CI was ≥-0.5 g/dL and superiority if the lower bound was ≥0 g/dL.|Treatment Difference|0.1||||0.515|TWO_SIDED|95.0|-0.21|0.41||The p-value for hemoglobin change from Baseline (Day 1) was adjusted for baseline hemoglobin level and hemodialysis status.|ANOVA||The 95% CI for hemoglobin change from Baseline (Day 1) was from an ANOVA model and adjusted for baseline hemoglobin level and hemodialysis status.|With LOCF Imputation: The p-value and two-sided 95% confidence interval (CI) for the treatment difference in mean change in hemoglobin from Baseline (Day 1) to Week 5 were generated based on an analysis of variance (ANOVA) model adjusted for baseline hemoglobin level and hemodialysis status.||0.41|-0.21|0.515
71102530|NCT01052779|141713288|NON_INFERIORITY|Non-inferiority was concluded if the lower bound of the 95% CI was ≥-0.5 g/dL and superiority if the lower bound was ≥0 g/dL.|Treatment Difference|0.09||||0.587|TWO_SIDED|95.0|-0.23|0.41||The p-value for hemoglobin change from Baseline (Day 1) was adjusted for baseline hemoglobin level and hemodialysis status.|ANOVA||The 95% CI for hemoglobin change from Baseline (Day 1) was from an ANOVA model and adjusted for baseline hemoglobin level and hemodialysis status.|Without Imputation (Sensitivity Analysis): The p-value and two-sided 95% CI for the treatment difference in mean change in hemoglobin from Baseline (Day 1) to Week 5 were generated based on an ANOVA model adjusted for baseline hemoglobin level and hemodialysis status.||0.41|-0.23|0.587
71102531|NCT03802916|141713292|SUPERIORITY|||||||0.0074||||||A p-value was calculated for the one-sample proportion test.|One-sample proportion test|||One-sample proportion test to determine if the overall preference for deferiprone DR was greater than chance (i.e., a 50% preference for each formulation)||||0.0074
71102532|NCT03802916|141713292|SUPERIORITY|||||||0.0002||||||A p-value was calculated for the one-sample proportion test.|One-sample proportion test|||One-sample proportion test to determine if the overall preference for deferiprone DR was greater than chance (i.e., a 50% preference for each formulation)||||0.0002
71102533|NCT06045273|141713403|SUPERIORITY||Slope|0.224|STANDARD_ERROR_OF_MEAN|0.064||0.0006|TWO_SIDED||||||Satterthwaite approximations|Also used a mixed models analysis||||||0.0006
71102534|NCT06045273|141713404|SUPERIORITY||Slope|0.084|STANDARD_ERROR_OF_MEAN|0.043||0.0504|TWO_SIDED||||||Satterthwaite approximations|Also used a mixed models analysis||||||0.0504
71102535|NCT06045273|141713405|SUPERIORITY||Slope|0.131|STANDARD_ERROR_OF_MEAN|0.04||0.00134|TWO_SIDED||||||Satterthwaite approximations|Also used a mixed models analysis||||||0.00134
71045398|NCT02709486|141599415|SUPERIORITY||LS Mean Ratio|0.81|STANDARD_ERROR_OF_MEAN|0.11||0.1305|TWO_SIDED|95.0|0.61|1.06|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.06|0.61|0.1305
71045399|NCT02709486|141599415|SUPERIORITY||LS Mean Ratio|0.85|STANDARD_ERROR_OF_MEAN|0.13||0.3057|TWO_SIDED|95.0|0.63|1.16|||Negative binomial model|||Week 24: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.16|0.63|0.3057
71008192|NCT01258738|141524627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.1413|TWO_SIDED|95.0|-0.95|0.14|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.14|-0.95|0.1413
71008193|NCT01258738|141524627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.0284|TWO_SIDED|95.0|-1.14|-0.06|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.06|-1.14|0.0284
71008194|NCT01258738|141524627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.0659|TWO_SIDED|95.0|-1.07|0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.03|-1.07|0.0659
71008195|NCT01258738|141524627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72||||0.0098|TWO_SIDED|95.0|-1.26|-0.18|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.18|-1.26|0.0098
71008196|NCT01258738|141524628|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71008197|NCT01258738|141524628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75||||0.0037|TWO_SIDED|95.0|-1.26|-0.25|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.25|-1.26|0.0037
71008198|NCT01258738|141524628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.0044|TWO_SIDED|95.0|-1.35|-0.25|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.25|-1.35|0.0044
71008199|NCT01258738|141524628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.0104|TWO_SIDED|95.0|-1.26|-0.17|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.17|-1.26|0.0104
71008200|NCT01258738|141524628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.006|TWO_SIDED|95.0|-1.33|-0.22|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.22|-1.33|0.0060
71008201|NCT01258738|141524629|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71008202|NCT01258738|141524629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.2268|TWO_SIDED|95.0|-0.8|0.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.19|-0.80|0.2268
71008203|NCT01258738|141524629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.1145|TWO_SIDED|95.0|-0.93|0.1|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.10|-0.93|0.1145
71008204|NCT01258738|141524629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0512|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.00|-1.00|0.0512
71008205|NCT01258738|141524629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.0509|TWO_SIDED|95.0|-1.02|0.0|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.00|-1.02|0.0509
71008206|NCT01258738|141524630|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71102536|NCT02743221|141713418|OTHER|This was a non-comparative study.|Hazard Ratio (HR)|0.71||||0.09|TWO_SIDED|95.0|0.48|1.06|||Cox proportional hazard model|Cox proportional hazard model with adjustment for the stratification factors (RAS status, performance status ECOG)||||1.06|0.48|0.09
70925811|NCT05746494|141345286|OTHER|Omnibus analysis||||||0.306|||||||t-test, 2 sided|||||||0.306
70925812|NCT05746494|141345287|OTHER|Omnibus analysis||||||0.041|||||||t-test, 2 sided|||||||0.041
70925813|NCT05746494|141345288|OTHER|Omnibus analysis||||||0.019|||||||t-test, 2 sided|||||||0.019
71008207|NCT01258738|141524630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.243|TWO_SIDED|95.0|-0.79|0.2|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.20|-0.79|0.2430
71008208|NCT01258738|141524630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.0384|TWO_SIDED|95.0|-1.09|-0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.03|-1.09|0.0384
71102537|NCT02743221|141713419|OTHER|||||||0.73|||||||Fisher Exact|||||||0.73
71102538|NCT02743221|141713420|OTHER||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.49|2.74||||||||2.74|0.49|
71102539|NCT02743221|141713421|OTHER|||||||0.22|||||||Fisher Exact|||||||0.22
71102540|NCT02743221|141713422|OTHER||Hazard Ratio (HR)|0.56||||0.04|TWO_SIDED|95.0|0.32|0.98|||Cox proportional hazard model|||||0.98|0.32|0.04
71102541|NCT04770285|141713432|SUPERIORITY||Treatment Difference|-1.78||||0.0568|TWO_SIDED|95.0|-3.6|0.05|||MMRM|p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.||||0.05|-3.60|0.0568
71102542|NCT04770285|141713433|SUPERIORITY||Treatment Difference|-0.77||||0.0705|TWO_SIDED|95.0|-1.61|0.07|||MMRM|p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.||||0.07|-1.61|0.0705
71102543|NCT04770285|141713434|SUPERIORITY||Treatment Difference|-0.62||||0.3687|TWO_SIDED|95.0|-1.99|0.74||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 2||0.74|-1.99|0.3687
71008209|NCT01258738|141524630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.0797|TWO_SIDED|95.0|-1.03|0.06|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.06|-1.03|0.0797
71008210|NCT01258738|141524630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.2186|TWO_SIDED|95.0|-0.9|0.21|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.21|-0.90|0.2186
71008211|NCT01258738|141524631|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71008212|NCT01258738|141524631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.141|TWO_SIDED|95.0|-0.96|0.14|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.14|-0.96|0.1410
71008213|NCT01258738|141524631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.2299|TWO_SIDED|95.0|-0.88|0.21|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.21|-0.88|0.2299
71008214|NCT01258738|141524631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.3221|TWO_SIDED|95.0|-0.87|0.29|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.29|-0.87|0.3221
71008215|NCT01258738|141524631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.1891|TWO_SIDED|95.0|-0.99|0.2|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.20|-0.99|0.1891
71008216|NCT01258738|141524632|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71008217|NCT01258738|141524632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.108|TWO_SIDED|95.0|-0.9|0.09|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.09|-0.90|0.1080
71008218|NCT01258738|141524632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.0389|TWO_SIDED|95.0|-1.06|-0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.03|-1.06|0.0389
71008219|NCT01258738|141524632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.1181|TWO_SIDED|95.0|-0.98|0.11|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.11|-0.98|0.1181
71008220|NCT01258738|141524632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.2271|TWO_SIDED|95.0|-0.94|0.22|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.22|-0.94|0.2271
71102544|NCT04770285|141713434|SUPERIORITY||Treatment Difference|-1.45||||0.0828|TWO_SIDED|95.0|-3.1|0.19||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 4||0.19|-3.10|0.0828
71102545|NCT04770285|141713435|SUPERIORITY||Treatment Difference|-0.34||||0.3549|TWO_SIDED|95.0|-1.06|0.38||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 2||0.38|-1.06|0.3549
71102546|NCT04770285|141713435|SUPERIORITY||Treatment Difference|-0.28||||0.4948|TWO_SIDED|95.0|-1.09|0.53||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 4||0.53|-1.09|0.4948
71102547|NCT04770285|141713436|SUPERIORITY||Ratio of Response Rate|1.68||||0.142|TWO_SIDED|95.0|0.84|3.34||p-value was calculated by Cochran-Mantel-Haenzsel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 2||3.34|0.84|0.1420
71102548|NCT04770285|141713436|SUPERIORITY||Ratio of Response Rate|1.31||||0.2939|TWO_SIDED|95.0|0.79|2.16||p-value was calculated by Cochran-Mantel-Haenzsel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 4||2.16|0.79|0.2939
71102549|NCT04770285|141713436|SUPERIORITY||Ratio of Response Rate|1.38||||0.0884|TWO_SIDED|95.0|0.96|1.99||p-value was calculated by Cochran-Mantel-Haenzsel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 6||1.99|0.96|0.0884
71102550|NCT04770285|141713437|SUPERIORITY||Treatment Difference|-0.19||||0.0039|TWO_SIDED|95.0|-0.32|-0.06||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 2||-0.06|-0.32|0.0039
71008221|NCT01258738|141524633|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71008222|NCT01258738|141524633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75||||0.0044|TWO_SIDED|95.0|-1.27|-0.24|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.24|-1.27|0.0044
71102551|NCT04770285|141713437|SUPERIORITY||Treatment Difference|-0.32||||0.0003|TWO_SIDED|95.0|-0.5|-0.15||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 4||-0.15|-0.50|0.0003
71102552|NCT04770285|141713437|SUPERIORITY||Treatment Difference|-0.26||||0.0098|TWO_SIDED|95.0|-0.46|-0.06||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 6||-0.06|-0.46|0.0098
71102553|NCT04770285|141713438|SUPERIORITY||Treatment Difference|-1.02||||0.4463|TWO_SIDED|95.0|-3.66|1.61||p-value was calculated by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|ANCOVA|||||1.61|-3.66|0.4463
71102554|NCT04770285|141713439|SUPERIORITY||Treatment Difference|-1.29||||0.0102|TWO_SIDED|95.0|-2.28|-0.31||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 4||-0.31|-2.28|0.0102
71102555|NCT04770285|141713439|SUPERIORITY||Treatment Difference|-1.58||||0.0029|TWO_SIDED|95.0|-2.62|-0.54||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 6||-0.54|-2.62|0.0029
71102556|NCT04770285|141713440|SUPERIORITY||Ratio of Response Rate|1.18||||0.5757|TWO_SIDED|95.0|0.65|2.16||p-value was calculated by Cochran-Mantel-Haenzsel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 2||2.16|0.65|0.5757
71102557|NCT04770285|141713440|SUPERIORITY||Ratio of Response Rate|1.16||||0.5102|TWO_SIDED|95.0|0.75|1.78||p-value was calculated by Cochran-Mantel-Haenzsel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 4||1.78|0.75|0.5102
71102558|NCT04770285|141713440|SUPERIORITY||Ratio of Response Rate|1.15||||0.5342|TWO_SIDED|95.0|0.74|1.79||p-value was calculated by Cochran-Mantel-Haenzsel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 6||1.79|0.74|0.5342
71102559|NCT04770285|141713441|SUPERIORITY||Ratio of Response Rate|1.0|||||TWO_SIDED|95.0|0.82|1.22||||||Week 8||1.22|0.82|
71008223|NCT01258738|141524633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0455|TWO_SIDED|95.0|-1.09|-0.01|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.01|-1.09|0.0455
71102560|NCT04770285|141713441|SUPERIORITY||Ratio of Response Rate|1.05|||||TWO_SIDED|95.0|0.88|1.25||||||Week 10||1.25|0.88|
71102561|NCT03766399|141713466|OTHER||LS means difference|-0.44||||0.9511|TWO_SIDED|90.0|-12.9|12.0|||Linear Mixed Model|||Comparison of Part 2a (MAD) Cohort 1 Vs Part 2a (MAD) Cohort 2||12.0|-12.9|0.9511
71102562|NCT03766399|141713466|OTHER||LS means difference|-7.87||||0.2849|TWO_SIDED|90.0|-20.3|4.59|||Linear Mixed Model|||Comparison of Part 2a (MAD) Cohort 2 Vs Part 2a (MAD) Placebo||4.59|-20.3|0.2849
71102563|NCT03766399|141713466|OTHER||LS means difference|-8.31||||0.2595|TWO_SIDED|90.0|-20.8|4.14|||Linear Mixed Model|||Comparison of Part 2a (MAD) Cohort 1 Vs Part 2a (MAD) Placebo||4.14|-20.8|0.2595
71102564|NCT03766399|141713466|OTHER||LS means difference|-3.04||||0.3604|TWO_SIDED|90.0|-8.6|2.51|||Linear Mixed Model|||Comparison of Part 3a (DPI/PoM) Vs Part 3a (DPI/PoM) Placebo||2.51|-8.60|0.3604
71102565|NCT03766399|141713467|OTHER||LS means difference|-25.4||||0.7544|TWO_SIDED|90.0|-166.0|115.0|||Linear Mixed Model|||Comparison of Part 2a (MAD) Cohort 1 Vs Part 2a (MAD) Cohort 2||115|-166|0.7544
71102566|NCT03766399|141713467|OTHER||LS means difference|-73.3||||0.375|TWO_SIDED|90.0|-214.0|67.6|||Linear Mixed Model|||Comparison of Part 2a (MAD) Cohort 2 Vs Part 2a (MAD) Placebo||67.6|-214|0.3750
71102567|NCT03766399|141713467|OTHER||LS means difference|-98.7||||0.2377|TWO_SIDED|90.0|-240.0|42.3|||Linear Mixed Model|||Comparison of Part 2a (MAD) Cohort 1 Vs Part 2a (MAD) Placebo||42.3|-240|0.2377
71102568|NCT03766399|141713467|OTHER||LS means difference|-50.4||||0.1105|TWO_SIDED|90.0|-102.0|1.61|||Linear Mixed Model|||Comparison of Part 3a (DPI/PoM) Vs Part 3a (DPI/PoM) Placebo||1.61|-102|0.1105
71102569|NCT00437073|141713496|SUPERIORITY_OR_OTHER||percentage of participants|38.0|||||TWO_SIDED|95.0|13.9|68.4|||||The estimated value indicates the percentage of participants with CNS OR in the Lapatinib plus Capecitabine treatment arm.|||68.4|13.9|
71102570|NCT01441492|141713520|OTHER|||||||0.804|||||||Chi-squared|||the study is powered to be able to detect a 15% difference in the ≥ Grade II complication rate between the drain and no drain groups. A total of 342 evaluable patients will be needed for the two study groups (n=171 per group) in order to achieve 80% power to detect a 15% increase or decrease in the complication rate with a significance level of 0.05.||||0.804
71102571|NCT00666263|141713549|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squared means|35.13||||0.005|TWO_SIDED|95.0|8.81|61.46|||ANOVA|Fixed effects ANOVA with factors for sequence (1 or 2), nested within sequence, period (Cross-Over Period 1 or 2), \& treatment (IGIV, 10% or placebo)||||61.46|8.81|0.005
71102572|NCT00666263|141713550|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED|95.0|||||McNemar|||||||<0.001
71102573|NCT00666263|141713552|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squared means|32.54|||<|0.001|TWO_SIDED|95.0|14.01|51.06|||ANOVA|||||51.06|14.01|<0.001
71102574|NCT00666263|141713553|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED|95.0|||||McNemar|||||||<0.001
71102575|NCT00666263|141713557|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squared Means|6.03||||0.002|TWO_SIDED|95.0|2.14|9.92|||ANOVA|||||9.92|2.14|0.002
71102576|NCT00666263|141713559|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squared Means|-15.57|||<|0.001|TWO_SIDED|95.0|-24.37|-6.77|||ANOVA|||||-6.77|-24.37|<0.001
71102577|NCT00666263|141713561|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squared Means|-26.11|||<|0.001|TWO_SIDED|95.0|-38.96|-13.26|||ANOVA|||||-13.26|-38.96|<0.001
71102578|NCT00666263|141713563|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squared Means|-216.6||||0.059|TWO_SIDED|95.0|-490.41|57.22|||ANOVA|||||57.22|-490.41|0.059
71102579|NCT00666263|141713565|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED|95.0|||||McNemar|||||||<0.001
71102580|NCT00666263|141713566|SUPERIORITY_OR_OTHER_LEGACY|||||||0.021||95.0|||||McNemar|||||||0.021
71102581|NCT00062764|141713580|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||paired t-test|||||||0.004
71102582|NCT02378480|141713607|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|-0.7|||||TWO_SIDED|95.0|-6.3|4.9|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||4.9|-6.3|
71102583|NCT02378480|141713608|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|2.5|||||TWO_SIDED|95.0|-3.2|8.2|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||8.2|-3.2|
71008224|NCT01258738|141524633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.175|TWO_SIDED|95.0|-0.91|0.17|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.17|-0.91|0.1750
71008225|NCT01258738|141524633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.0379|TWO_SIDED|95.0|-1.12|-0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.03|-1.12|0.0379
71008226|NCT01258738|141524634|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71008227|NCT01258738|141524634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0826|TWO_SIDED|95.0|-0.98|0.06|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.06|-0.98|0.0826
71008228|NCT01258738|141524634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.1538|TWO_SIDED|95.0|-0.96|0.15|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.15|-0.96|0.1538
71008229|NCT01258738|141524634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0728|TWO_SIDED|95.0|-1.04|0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.05|-1.04|0.0728
71008230|NCT01258738|141524634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.0975|TWO_SIDED|95.0|-0.99|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.08|-0.99|0.0975
71008231|NCT01258738|141524635|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71008232|NCT01258738|141524635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.0186|TWO_SIDED|95.0|-1.18|-0.11|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.11|-1.18|0.0186
71008233|NCT01258738|141524635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0106|TWO_SIDED|95.0|-1.01|-0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.13|-1.01|0.0106
71008234|NCT01258738|141524635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.0048|TWO_SIDED|95.0|-1.11|-0.2|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.20|-1.11|0.0048
71008235|NCT01258738|141524635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81||||0.0016|TWO_SIDED|95.0|-1.31|-0.31|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.31|-1.31|0.0016
71008236|NCT01258738|141524636|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71102584|NCT02378480|141713609|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|2.8|||||TWO_SIDED|95.0|-1.0|6.9|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||6.9|-1.0|
71102585|NCT01217892|141713611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.084||0.0106|TWO_SIDED|95.0|-0.38|-0.05||significant at alpha=0.05 (2-sided) applying Hochberg's method across the two Dapagliflozin BID groups.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05 using Hochberg's method to control the overall Type I error across hypotheses in the two Dapagliflozin BID groups, two-sided)||-0.05|-0.38|0.0106
71008237|NCT01258738|141524636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.0058|TWO_SIDED|95.0|-1.37|-0.24|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.24|-1.37|0.0058
71008238|NCT01258738|141524636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.0064|TWO_SIDED|95.0|-1.42|-0.24|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.24|-1.42|0.0064
70925814|NCT03721952|141345296|SUPERIORITY||Avg. Intervention Effect (CON--INT)|0.13|STANDARD_ERROR_OF_MEAN|0.323||0.688|TWO_SIDED|95.0|-0.505|0.764|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.|Additional estimation information: Positive sign of estimate defined as lower average depression score \& negative sign of estimate defined as higher average depression score, over 3 follow-up points for the intervention group vs. the control group.|Superior outcome for Group2 (Facilitator-based INTERVENTION: Family)||0.764|-0.505|0.688
70925815|NCT03721952|141345296|SUPERIORITY|||||||0.51|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.510
70925816|NCT03721952|141345297|SUPERIORITY||Avg. Intervention Effect (CON--INT)|0.143|STANDARD_ERROR_OF_MEAN|0.323||0.658|TWO_SIDED|95.0|-0.491|0.777|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.|Additional estimation information: Positive sign of estimate defined as lower average anxiety score \& negative sign of estimate defined as higher average anxiety score, over 3 follow-up points for the intervention group vs. the control group.|Superior outcome for Group2 (Facilitator-based INTERVENTION: Family)||0.777|-0.491|0.658
70925817|NCT03721952|141345297|SUPERIORITY|||||||0.268|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.268
70925818|NCT03721952|141345298|SUPERIORITY||Avg. Intervention Effect (CON--INT)|-0.2|STANDARD_ERROR_OF_MEAN|0.077||0.01|TWO_SIDED|95.0|-0.353|-0.048|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.|Additional information: Positive sign of estimate defined as lower average quality-of-relationship score \& negative sign of estimate defined as higher average quality-of-relationship score over 3 follow-up points for intervention vs control groups.|Superior outcome for Group 2 (Facilitator-based INTERVENTION: Family)||-0.048|-0.353|0.010
70925819|NCT03721952|141345298|SUPERIORITY|||||||0.175|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.175
70925820|NCT03721952|141345299|SUPERIORITY||Avg. Intervention Effect (CON--INT)|-0.021|STANDARD_ERROR_OF_MEAN|0.092||0.817|TWO_SIDED|95.0|-0.203|0.16|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.|Additional information: Positive sign of estimate defined as lower average quality-of-relationship score \& negative sign of estimate defined as higher average quality-of-relationship score, over 3 follow-up points for intervention vs control group.|Superior outcome for Group 2 (Facilitator-based INTERVENTION: Family)||0.160|-0.203|0.817
71008239|NCT01258738|141524636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.23||||0.0002|TWO_SIDED|95.0|-1.85|-0.6|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.60|-1.85|0.0002
71008240|NCT01258738|141524636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.0134|TWO_SIDED|95.0|-1.49|-0.17|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.17|-1.49|0.0134
71008241|NCT01258738|141524637|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71008242|NCT01258738|141524637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0316|TWO_SIDED|95.0|-1.09|-0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.05|-1.09|0.0316
71008243|NCT01258738|141524637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.0973|TWO_SIDED|95.0|-0.99|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.08|-0.99|0.0973
71008244|NCT01258738|141524637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.0216|TWO_SIDED|95.0|-1.27|-0.1|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.10|-1.27|0.0216
71008245|NCT01258738|141524637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.2425|TWO_SIDED|95.0|-1.03|0.26|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.26|-1.03|0.2425
70925821|NCT03721952|141345299|SUPERIORITY|||||||0.949|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.949
70925822|NCT03721952|141345300|SUPERIORITY||Avg. Intervention Effect (CON--INT)|-0.45|STANDARD_ERROR_OF_MEAN|0.239||0.06|TWO_SIDED|95.0|-0.919|0.02|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.|Additional information: Positive sign of estimate defined as lower average preparation score \& negative sign of estimate defined as higher average preparation score, over 3 follow-up points for intervention vs control group.|Superior outcome for Group 2 (Facilitator-based INTERVENTION: Family)||0.020|-0.919|0.060
70925823|NCT03721952|141345300|SUPERIORITY|||||||0.701|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.701
70925824|NCT03721952|141345301|SUPERIORITY||Avg. Intervention Effect (CON--INT)|-0.393||||0.053|TWO_SIDED|95.0|-0.791|0.005|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.|Additional estimation information: Positive sign of estimate defined as lower average goal-concordant care \& negative sign of estimate defined as higher average goal-concordant care, over 3 follow-up points for intervention group vs. control group.|Superior outcome for Group 2 (Facilitator-based INTERVENTION: Family)||0.005|-0.791|0.053
71045400|NCT02709486|141599415|SUPERIORITY||LS Mean Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.13||0.2056|TWO_SIDED|95.0|0.61|1.11|||Negative binomial model|||Week 24: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.11|0.61|0.2056
71045401|NCT02709486|141599417|SUPERIORITY||LS Mean Ratio|0.62|STANDARD_ERROR_OF_MEAN|0.15||0.0441|TWO_SIDED|95.0|0.39|0.99|||Negative binomial model|||Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.99|0.39|0.0441
71045402|NCT02709486|141599417|SUPERIORITY||LS Mean Ratio|0.73|STANDARD_ERROR_OF_MEAN|0.17||0.1895|TWO_SIDED|95.0|0.46|1.17|||Negative binomial model|||Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.17|0.46|0.1895
71045403|NCT02709486|141599417|SUPERIORITY||LS Mean Ratio|0.6|STANDARD_ERROR_OF_MEAN|0.16||0.0567|TWO_SIDED|95.0|0.35|1.01|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.01|0.35|0.0567
71045404|NCT02709486|141599417|SUPERIORITY||LS Mean Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.2||0.296|TWO_SIDED|95.0|0.44|1.28|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.28|0.44|0.2960
71045405|NCT02709486|141599417|SUPERIORITY||LS Mean Ratio|0.65|STANDARD_ERROR_OF_MEAN|0.18||0.1215|TWO_SIDED|95.0|0.37|1.12|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.12|0.37|0.1215
71045406|NCT02709486|141599417|SUPERIORITY||LS Mean Ratio|0.77|STANDARD_ERROR_OF_MEAN|0.22||0.3569|TWO_SIDED|95.0|0.44|1.34|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.34|0.44|0.3569
71045407|NCT02709486|141599417|SUPERIORITY||LS Mean Ratio|0.67|STANDARD_ERROR_OF_MEAN|0.21||0.2096|TWO_SIDED|95.0|0.36|1.25|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.25|0.36|0.2096
71045408|NCT02709486|141599417|SUPERIORITY||LS Mean Ratio|0.69|STANDARD_ERROR_OF_MEAN|0.22||0.2387|TWO_SIDED|95.0|0.37|1.28|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.28|0.37|0.2387
71045409|NCT02709486|141599417|SUPERIORITY||LS Mean Ratio|0.71|STANDARD_ERROR_OF_MEAN|0.22||0.2627|TWO_SIDED|95.0|0.39|1.29|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.29|0.39|0.2627
71045410|NCT02709486|141599417|SUPERIORITY||LS Mean Ratio|0.72|STANDARD_ERROR_OF_MEAN|0.22||0.2863|TWO_SIDED|95.0|0.4|1.31|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group||1.31|0.40|0.2863
71045411|NCT02709486|141599417|SUPERIORITY||LS Mean Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.27||0.556|TWO_SIDED|95.0|0.43|1.58|||Negative binomial model|||Week 24: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.58|0.43|0.5560
71045412|NCT02709486|141599417|SUPERIORITY||LS Mean Ratio|0.8|STANDARD_ERROR_OF_MEAN|0.26||0.5076|TWO_SIDED|95.0|0.42|1.53|||Negative binomial model|||Week 24: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.53|0.42|0.5076
71045413|NCT02139124|141599448|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.675|TWO_SIDED|95.0|-6.6|2.6||The model includes terms for treatment and baseline Clinician ADHD-5-RS score as a covariate.|ANCOVA|Analyses utilize ANCOVA models with Dunnett's adjustments for multiple pairwise comparisons for each active dose group with placebo.||"The null hypothesis is the mean Clinician ADHD-5-RS total score at Visit 6 is not different between the active treatment and placebo."||2.6|-6.6|0.6750
71045414|NCT02139124|141599448|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.0013|TWO_SIDED|95.0|-11.5|-2.2||The model includes terms for treatment and baseline Clinician ADHD-5-RS score as a covariate.|ANCOVA|Analyses utilize ANCOVA models with Dunnett's adjustments for multiple pairwise comparisons for each active dose group with placebo.||The null hypothesis is the mean Clinician ADHD-5-RS total score at Visit 6 is not different between the active treatment and placebo||-2.2|-11.5|0.0013
71045415|NCT02139124|141599448|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.672|TWO_SIDED|95.0|-6.8|2.7||The model includes terms for treatment and baseline Clinician ADHD-5-RS score as a covariate.|ANCOVA|Analyses utilize ANCOVA models with Dunnett's adjustments for multiple pairwise comparisons for each active dose group with placebo.||"The null hypothesis is the mean Clinician ADHD-5-RS total score at Visit 6 is not different between the active treatment and placebo"||2.7|-6.8|0.6720
71008246|NCT01258738|141524638|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71008247|NCT01258738|141524638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.2688|TWO_SIDED|95.0|-0.92|0.26|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.26|-0.92|0.2688
71008248|NCT01258738|141524638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.0866|TWO_SIDED|95.0|-1.17|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.08|-1.17|0.0866
71008249|NCT01258738|141524638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.0277|TWO_SIDED|95.0|-1.34|-0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.08|-1.34|0.0277
71008250|NCT01258738|141524638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.239|TWO_SIDED|95.0|-1.04|0.26|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.26|-1.04|0.2390
71008251|NCT01258738|141524639|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71008252|NCT01258738|141524639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0928|TWO_SIDED|95.0|-1.0|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.08|-1.00|0.0928
71008253|NCT01258738|141524639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.0139|TWO_SIDED|95.0|-1.27|-0.15|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.15|-1.27|0.0139
71008254|NCT01258738|141524639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94||||0.0017|TWO_SIDED|95.0|-1.53|-0.36|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.36|-1.53|0.0017
71008255|NCT01258738|141524639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02||||0.0008|TWO_SIDED|95.0|-1.61|-0.43|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.43|-1.61|0.0008
71008256|NCT01258738|141524640|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71008257|NCT01258738|141524640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.4559|TWO_SIDED|95.0|-0.84|0.38|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.38|-0.84|0.4559
71008258|NCT01258738|141524640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.0345|TWO_SIDED|95.0|-1.28|-0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.05|-1.28|0.0345
71008259|NCT01258738|141524640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.034|TWO_SIDED|95.0|-1.3|-0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.05|-1.30|0.0340
71008260|NCT01258738|141524640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.0634|TWO_SIDED|95.0|-1.24|0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.03|-1.24|0.0634
71008261|NCT01258738|141524641|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71008262|NCT01258738|141524641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.0007|TWO_SIDED|95.0|-1.56|-0.43|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.43|-1.56|0.0007
71008263|NCT01258738|141524641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81||||0.0073|TWO_SIDED|95.0|-1.39|-0.22|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.22|-1.39|0.0073
70925825|NCT03721952|141345301|SUPERIORITY|||||||0.039|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.039
70925826|NCT03721952|141345302|SUPERIORITY||Avg. Intervention Effect (CON--INT)|0.636||||0.239|TWO_SIDED|95.0|-0.425|1.7|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.||Superior outcome for Group2 (Facilitator-based INTERVENTION: Family)||1.700|-0.425|0.239
70925827|NCT03721952|141345302|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.170
70925828|NCT03721952|141345303|SUPERIORITY||Slope|0.089|STANDARD_ERROR_OF_MEAN|0.041||0.029|TWO_SIDED|95.0|0.009|0.169|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher proportion of readmissions \& negative sign of estimate defined as lower proportion of readmissions, for the intervention group vs. the control group|Superior outcome for Group2 (Patient-Intervention)||0.169|0.009|0.029
70925829|NCT03721952|141345304|SUPERIORITY||Slope|1.078|STANDARD_ERROR_OF_MEAN|0.808||0.183|TWO_SIDED|95.0|-0.511|2.666|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher number of hospital free days \& negative sign of estimate defined as lower number of hospital free days, for the intervention group vs. the control group.|Superior outcome for Group2 (Patient-Intervention)||2.666|-0.511|0.183
70925830|NCT03721952|141345305|SUPERIORITY||Slope|1.687|STANDARD_ERROR_OF_MEAN|3.157||0.593|TWO_SIDED|95.0|-4.518|7.892|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher number of hospital free days \& negative sign of estimate defined as lower number of hospital free days, for the intervention group vs. the control group.|Superior outcome for Group2 (Patient-Intervention)||7.892|-4.518|0.593
71008264|NCT01258738|141524641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||0.0094|TWO_SIDED|95.0|-1.48|-0.21|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.21|-1.48|0.0094
71008265|NCT01258738|141524641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87||||0.012|TWO_SIDED|95.0|-1.54|-0.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.19|-1.54|0.0120
71008266|NCT01258738|141524642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.96||||0.0029|TWO_SIDED|95.0|7.54|32.37|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||32.37|7.54|0.0029
71008267|NCT01258738|141524642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.59||||0.01|TWO_SIDED|95.0|3.18|19.99|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||19.99|3.18|0.0100
71008268|NCT01258738|141524642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.75||||0.012|TWO_SIDED|95.0|3.62|23.89|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||23.89|3.62|0.0120
71008269|NCT01258738|141524642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.12||||0.0213|TWO_SIDED|95.0|3.04|27.2|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||27.20|3.04|0.0213
71008270|NCT01258738|141524643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.88||||0.2755|TWO_SIDED|95.0|-5.15|20.92|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||20.92|-5.15|0.2755
71008271|NCT01258738|141524643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.57||||0.195|TWO_SIDED|95.0|-4.39|21.54|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||21.54|-4.39|0.1950
71008272|NCT01258738|141524643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.99||||0.0278|TWO_SIDED|95.0|0.72|27.26|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||27.26|0.72|0.0278
71008273|NCT01258738|141524643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.29||||0.0174|TWO_SIDED|95.0|2.28|28.3|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||28.30|2.28|0.0174
71008274|NCT01258738|141524644|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71008275|NCT01258738|141524644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.0201|TWO_SIDED|95.0|-0.99|-0.09|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4 and 12 data only. Week 4||-0.09|-0.99|0.0201
71008276|NCT01258738|141524644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0558|TWO_SIDED|95.0|-1.02|0.01|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4 and 12 data only. Week 12||0.01|-1.02|0.0558
71008277|NCT01258738|141524645|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71008278|NCT01258738|141524645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.6741|TWO_SIDED|95.0|-0.18|0.28|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.28|-0.18|0.6741
71008279|NCT01258738|141524645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3896|TWO_SIDED|95.0|-0.33|0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.13|-0.33|0.3896
71008280|NCT01258738|141524645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.7468|TWO_SIDED|95.0|-0.22|0.31|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.31|-0.22|0.7468
71008281|NCT01258738|141524645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.6871|TWO_SIDED|95.0|-0.35|0.23|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.23|-0.35|0.6871
71008282|NCT01258738|141524646|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71008283|NCT01258738|141524646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.4332|TWO_SIDED|95.0|-0.57|1.32|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||1.32|-0.57|0.4332
71008284|NCT01258738|141524646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9947|TWO_SIDED|95.0|-0.98|0.98|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.98|-0.98|0.9947
71008285|NCT01258738|141524646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74||||0.1558|TWO_SIDED|95.0|-0.28|1.75|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||1.75|-0.28|0.1558
71008286|NCT01258738|141524646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21||||0.0488|TWO_SIDED|95.0|0.03|2.39|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||2.39|0.03|0.0488
71008287|NCT01258738|141524647|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71008288|NCT01258738|141524647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.7645|TWO_SIDED|95.0|-2.06|2.8|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||2.80|-2.06|0.7645
71008289|NCT01258738|141524647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03||||0.4178|TWO_SIDED|95.0|-1.48|3.55|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||3.55|-1.48|0.4178
71045416|NCT02139124|141599448|SUPERIORITY||Mean Difference (Final Values)|-8.1||||0.0002|TWO_SIDED|95.0|-12.9|-3.2||The model include terms for treatment and baseline Clinician ADHD-5-RS score as a covariate.|ANCOVA|Analyses utilize ANCOVA models with Dunnett's adjustments for multiple pairwise comparisons for each active dose group with placebo.||"The null hypothesis is the mean Clinician ADHD-5-RS total score at Visit 6 is not different between the active treatment and placebo"||-3.2|-12.9|0.0002
71008290|NCT01258738|141524647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06||||0.443|TWO_SIDED|95.0|-1.67|3.79|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||3.79|-1.67|0.4430
71008291|NCT01258738|141524647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.39||||0.1095|TWO_SIDED|95.0|-0.54|5.31|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||5.31|-0.54|0.1095
71008292|NCT01258738|141524648|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71008293|NCT01258738|141524648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9504|TWO_SIDED|95.0|-0.46|0.49|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.49|-0.46|0.9504
71045417|NCT02691741|141599449|NON_INFERIORITY|Non-inferiority is demonstrated if the upper confidence limit of the two-sided 90% confidence interval on the treatment difference is less than 0.1 logMAR unit.|Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.0193|||TWO_SIDED|90.0|-0.093|-0.029||||||||-0.029|-0.093|
71045418|NCT02691741|141599450|SUPERIORITY||Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.0193||0.002|TWO_SIDED|90.0|-0.093|-0.029|||Repeated Measures Analysis of Variance|||||-0.029|-0.093|0.002
71045419|NCT02691741|141599451|NON_INFERIORITY|Non-inferiority is demonstrated if the upper confidence limit of the two-sided 90% confidence interval on the treatment difference is less than 0.1 logMAR unit.|Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.0157|||TWO_SIDED|95.0|-0.019|0.043||||||||0.043|-0.019|
71045420|NCT02691741|141599451|SUPERIORITY|||||||0.455|||||||Repeated Measures Analysis of Variance|||||||0.455
71102586|NCT01217892|141713611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.0843|<|0.0001|TWO_SIDED|95.0|-0.52|-0.18||significant at alpha=0.05 (2-sided) applying Hochberg's method across the two Dapagliflozin BID groups.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05 using Hochberg's method to control the overall Type I error across hypotheses in the two Dapagliflozin BID groups, two-sided)||-0.18|-0.52|<0.0001
71102587|NCT01217892|141713612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.82|STANDARD_ERROR_OF_MEAN|0.363|<|0.0001|TWO_SIDED|95.0|-2.53|-1.1||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c \<7.0% vs \>=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)||-1.10|-2.53|<0.0001
71102588|NCT01217892|141713612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.18|STANDARD_ERROR_OF_MEAN|0.3636|<|0.0001|TWO_SIDED|95.0|-2.89|-1.46||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c \<7.0% vs \>=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)||-1.46|-2.89|<0.0001
71102589|NCT01217892|141713613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.7|STANDARD_ERROR_OF_MEAN|3.04|<|0.0001|TWO_SIDED|95.0|-21.7|-9.7||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c \<7.0% vs \>=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)||-9.7|-21.7|<0.0001
71102590|NCT01217892|141713613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.7|STANDARD_ERROR_OF_MEAN|3.039|<|0.0001|TWO_SIDED|95.0|-22.7|-10.7||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c \<7.0% vs \>=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)||-10.7|-22.7|<0.0001
71008294|NCT01258738|141524648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.4971|TWO_SIDED|95.0|-0.7|0.34|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.34|-0.70|0.4971
71045421|NCT02691741|141599452|NON_INFERIORITY|Non-inferiority is demonstrated if the upper confidence limit of the two-sided 90% confidence interval on the treatment difference is less than 0.1 logMAR unit.|Mean Difference (Final Values)|-0.051|STANDARD_ERROR_OF_MEAN|0.0168|||TWO_SIDED|90.0|-0.078|-0.023||||||||-0.023|-0.078|
71045422|NCT02691741|141599452|SUPERIORITY|||||||0.003|||||||Repeated Measures Analysis of Variance|||||||0.003
71045423|NCT03465436|141599459|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-3.5|||||TWO_SIDED|90.0|-5.41|-1.59|||Mixed Models Analysis|||30 minutes postdose||-1.59|-5.41|
71008295|NCT01258738|141524648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.8999|TWO_SIDED|95.0|-0.47|0.54|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.54|-0.47|0.8999
71045424|NCT03465436|141599459|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-3.54|||||TWO_SIDED|90.0|-5.18|-1.89|||Mixed Models Analysis|||1 hour postdose||-1.89|-5.18|
71045425|NCT03465436|141599459|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-4.1|||||TWO_SIDED|90.0|-5.77|-2.43|||Mixed Models Analysis|||1.5 hours postdose||-2.43|-5.77|
71045426|NCT03465436|141599459|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-3.21|||||TWO_SIDED|90.0|-5.14|-1.28|||Mixed Models Analysis|||2 hours postdose||-1.28|-5.14|
71045427|NCT03465436|141599459|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.46|||||TWO_SIDED|90.0|-4.41|-0.51|||Mixed Models Analysis|||2.5 hours postdose||-0.51|-4.41|
71045428|NCT03465436|141599459|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.91|||||TWO_SIDED|90.0|-2.84|1.03|||Mixed Models Analysis|||3 hours postdose||1.03|-2.84|
71008296|NCT01258738|141524648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9712|TWO_SIDED|95.0|-0.6|0.62|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.62|-0.60|0.9712
71008297|NCT01258738|141524649|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71008298|NCT01258738|141524649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.4556|TWO_SIDED|95.0|-1.46|3.24|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||3.24|-1.46|0.4556
71008299|NCT01258738|141524649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.85||||0.0543|TWO_SIDED|95.0|-0.05|5.75|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||5.75|-0.05|0.0543
71008300|NCT01258738|141524649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.26||||0.1754|TWO_SIDED|95.0|-1.02|5.53|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||5.53|-1.02|0.1754
71008301|NCT01258738|141524649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.45||||0.3985|TWO_SIDED|95.0|-1.93|4.82|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||4.82|-1.93|0.3985
71008302|NCT01258738|141524650|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71008303|NCT01258738|141524650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.2823|TWO_SIDED|95.0|-0.18|0.62|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.62|-0.18|0.2823
71008304|NCT01258738|141524650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.4029|TWO_SIDED|95.0|-0.23|0.58|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.58|-0.23|0.4029
71008305|NCT01258738|141524650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.511|TWO_SIDED|95.0|-0.25|0.51|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.51|-0.25|0.5110
71008306|NCT01258738|141524650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.5844|TWO_SIDED|95.0|-0.32|0.56|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.56|-0.32|0.5844
71008307|NCT01258738|141524651|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Most within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71008308|NCT01258738|141524651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.0129|TWO_SIDED|95.0|-0.95|-0.11|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.11|-0.95|0.0129
71008309|NCT01258738|141524651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.6003|TWO_SIDED|95.0|-0.61|0.35|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.35|-0.61|0.6003
71008310|NCT01258738|141524651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.0911|TWO_SIDED|95.0|-0.89|0.07|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.07|-0.89|0.0911
71008311|NCT01258738|141524651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.3144|TWO_SIDED|95.0|-0.73|0.24|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.24|-0.73|0.3144
71008312|NCT01258738|141524652|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Most within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71008313|NCT01258738|141524652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.6476|TWO_SIDED|95.0|-0.46|0.29|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12, data only. Week 2||0.29|-0.46|0.6476
71008314|NCT01258738|141524652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9777|TWO_SIDED|95.0|-0.4|0.39|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12, data only. Week 4||0.39|-0.40|0.9777
71008315|NCT01258738|141524652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.4453|TWO_SIDED|95.0|-0.28|0.65|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12, data only. Week 8||0.65|-0.28|0.4453
71008316|NCT01258738|141524652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.5782|TWO_SIDED|95.0|-0.33|0.6|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12, data only. Week 12||0.60|-0.33|0.5782
71008317|NCT01258738|141524653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96||||0.0414|TWO_SIDED|95.0|-1.88|-0.04|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.||-0.04|-1.88|0.0414
71045429|NCT03465436|141599459|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.62|||||TWO_SIDED|90.0|-2.53|1.29|||Mixed Models Analysis|||3.5 hours postdose||1.29|-2.53|
71045430|NCT03465436|141599459|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|0.07|||||TWO_SIDED|90.0|-1.84|1.99|||Mixed Models Analysis|||4 hours postdose||1.99|-1.84|
71045431|NCT03465436|141599459|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-1.06|||||TWO_SIDED|90.0|-3.22|1.1|||Mixed Models Analysis|||6 hours postdose||1.10|-3.22|
71045432|NCT03465436|141599459|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.73|||||TWO_SIDED|90.0|-4.88|-0.57|||Mixed Models Analysis|||8 hours postdose||-0.57|-4.88|
71045433|NCT03465436|141599459|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.05|||||TWO_SIDED|90.0|-3.77|-0.32|||Mixed Models Analysis|||12 hours postdose||-0.32|-3.77|
71045434|NCT03465436|141599459|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|0.21|||||TWO_SIDED|90.0|-1.9|2.33|||Mixed Models Analysis|||24 hours postdose||2.33|-1.90|
71008318|NCT01258738|141524654|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
71008319|NCT01258738|141524654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.93|||<|0.001|TWO_SIDED|95.0|-4.16|-1.7|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.||-1.70|-4.16|<0.001
71045435|NCT03465436|141599459|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-3.83|||||TWO_SIDED|90.0|-5.56|-2.11|||Mixed Models Analysis|||30 minutes postdose||-2.11|-5.56|
71045436|NCT03465436|141599459|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.75|||||TWO_SIDED|90.0|-2.75|1.25|||Mixed Models Analysis|||1 hour postdose||1.25|-2.75|
71045437|NCT03465436|141599459|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|0.45|||||TWO_SIDED|90.0|-1.49|2.38|||Mixed Models Analysis|||1.5 hours postdose||2.38|-1.49|
71008320|NCT01258738|141524655|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
71008321|NCT01258738|141524655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96||||0.0414|TWO_SIDED|95.0|-1.88|-0.04|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.||-0.04|-1.88|0.0414
71045438|NCT03465436|141599459|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|2.58|||||TWO_SIDED|90.0|0.58|4.58|||Mixed Models Analysis|||2 hours postdose||4.58|0.58|
71045439|NCT03465436|141599459|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|2.85|||||TWO_SIDED|90.0|0.73|4.98|||Mixed Models Analysis|||2.5 hours postdose||4.98|0.73|
71045440|NCT03465436|141599459|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|3.94|||||TWO_SIDED|90.0|1.85|6.03|||Mixed Models Analysis|||3 hours postdose||6.03|1.85|
71045441|NCT03465436|141599459|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|5.28|||||TWO_SIDED|90.0|3.61|6.95|||Mixed Models Analysis|||3.5 hours postdose||6.95|3.61|
71045442|NCT03465436|141599459|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|6.94|||||TWO_SIDED|90.0|4.99|8.89|||Mixed Models Analysis|||4 hours postdose||8.89|4.99|
71045443|NCT03465436|141599459|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|3.13|||||TWO_SIDED|90.0|0.93|5.34|||Mixed Models Analysis|||6 hours postdose||5.34|0.93|
71045444|NCT03465436|141599459|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|2.09|||||TWO_SIDED|90.0|-0.23|4.4|||Mixed Models Analysis|||8 hours postdose||4.40|-0.23|
71045445|NCT03465436|141599459|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|1.37|||||TWO_SIDED|90.0|-0.57|3.3|||Mixed Models Analysis|||12 hours postdose||3.30|-0.57|
71045446|NCT03465436|141599459|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.29|||||TWO_SIDED|90.0|-2.21|1.63|||Mixed Models Analysis|||24 hours postdose||1.63|-2.21|
71045447|NCT03465436|141599459|SUPERIORITY||LS Mean|7.32|||||TWO_SIDED|90.0|5.03|9.6|||Mixed Models Analysis|||30 minutes postdose||9.60|5.03|
71045448|NCT03465436|141599459|SUPERIORITY||LS Mean|12.28|||||TWO_SIDED|90.0|10.47|14.1|||Mixed Models Analysis|||1 hour postdose||14.10|10.47|
71045449|NCT03465436|141599459|SUPERIORITY||LS Mean|11.27|||||TWO_SIDED|90.0|9.54|13.0|||Mixed Models Analysis|||1.5 hours postdose||13.00|9.54|
71045450|NCT03465436|141599459|SUPERIORITY||LS Mean|11.92|||||TWO_SIDED|90.0|9.97|13.87|||Mixed Models Analysis|||2 hours postdose||13.87|9.97|
71045451|NCT03465436|141599459|SUPERIORITY||LS Mean|10.98|||||TWO_SIDED|90.0|9.17|12.79|||Mixed Models Analysis|||2.5 hours postdose||12.79|9.17|
71045452|NCT03465436|141599459|SUPERIORITY||LS Mean|11.99|||||TWO_SIDED|90.0|10.1|13.87|||Mixed Models Analysis|||3 hours postdose||13.87|10.10|
71008322|NCT01258738|141524656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.0132|TWO_SIDED|95.0|-0.72|-0.08|||ANCOVA|||"Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made.~Comparative analysis was carried out for Week 12 data only."||-0.08|-0.72|0.0132
71008323|NCT01258738|141524657|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
71008324|NCT01258738|141524657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.2438|TWO_SIDED|95.0|-0.52|0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.13|-0.52|0.2438
71008325|NCT01258738|141524657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.1958|TWO_SIDED|95.0|-0.42|0.09|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.09|-0.42|0.1958
71008326|NCT01258738|141524657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.1624|TWO_SIDED|95.0|-0.46|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.08|-0.46|0.1624
71008327|NCT01258738|141524657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.0091|TWO_SIDED|95.0|-0.54|-0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.08|-0.54|0.0091
71008328|NCT01258738|141524658|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
71008329|NCT01258738|141524658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.0836|TWO_SIDED|95.0|-1.32|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.08|-1.32|0.0836
71008330|NCT01258738|141524658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.5402|TWO_SIDED|95.0|-1.02|0.54|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.54|-1.02|0.5402
71008331|NCT01258738|141524658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.8167|TWO_SIDED|95.0|-0.69|0.87|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.87|-0.69|0.8167
71045453|NCT03465436|141599459|SUPERIORITY||LS Mean|12.19|||||TWO_SIDED|90.0|10.32|14.05|||Mixed Models Analysis|||3.5 hours postdose||14.05|10.32|
71045454|NCT03465436|141599459|SUPERIORITY||LS Mean|11.68|||||TWO_SIDED|90.0|9.83|13.52|||Mixed Models Analysis|||4 hours postdose||13.52|9.83|
71045455|NCT03465436|141599459|SUPERIORITY||LS Mean|8.24|||||TWO_SIDED|90.0|6.1|10.39|||Mixed Models Analysis|||6 hours postdose||10.39|6.10|
71045456|NCT03465436|141599459|SUPERIORITY||LS Mean|7.87|||||TWO_SIDED|90.0|5.66|10.07|||Mixed Models Analysis|||8 hours postdose||10.07|5.66|
71045457|NCT03465436|141599459|SUPERIORITY||LS Mean|6.35|||||TWO_SIDED|90.0|4.32|8.38|||Mixed Models Analysis|||12 hours postdose||8.38|4.32|
71045458|NCT03465436|141599459|SUPERIORITY||LS Mean|6.13|||||TWO_SIDED|90.0|3.88|8.38|||Mixed Models Analysis|||24 hours postdose||8.38|3.88|
71045459|NCT03465436|141599460|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-4.49|||||TWO_SIDED|90.0|-6.47|-2.52|||Mixed Models Analysis|||30 minutes postdose||-2.52|-6.47|
71045460|NCT03465436|141599460|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-5.3|||||TWO_SIDED|90.0|-7.18|-3.42|||Mixed Models Analysis|||1 hour postdose||-3.42|-7.18|
71045461|NCT03465436|141599460|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-5.7|||||TWO_SIDED|90.0|-7.57|-3.82|||Mixed Models Analysis|||1.5 hours postdose||-3.82|-7.57|
71008332|NCT01258738|141524658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9891|TWO_SIDED|95.0|-0.72|0.73|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.73|-0.72|0.9891
71008333|NCT01258738|141524659|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
71008334|NCT01258738|141524659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.6148|TWO_SIDED|95.0|-0.08|0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.05|-0.08|0.6148
71008335|NCT01258738|141524659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.2547|TWO_SIDED|95.0|-0.11|0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.03|-0.11|0.2547
71008336|NCT01258738|141524659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.1208|TWO_SIDED|95.0|-0.08|0.01|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.01|-0.08|0.1208
71045462|NCT03465436|141599460|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-4.47|||||TWO_SIDED|90.0|-6.64|-2.3|||Mixed Models Analysis|||2 hours postdose||-2.30|-6.64|
71045463|NCT03465436|141599460|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-4.53|||||TWO_SIDED|90.0|-6.87|-2.19|||Mixed Models Analysis|||2.5 hours postdose||-2.19|-6.87|
71045464|NCT03465436|141599460|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.74|||||TWO_SIDED|90.0|-4.9|-0.59|||Mixed Models Analysis|||3 hours postdose||-0.59|-4.90|
71045465|NCT03465436|141599460|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-1.74|||||TWO_SIDED|90.0|-3.86|0.39|||Mixed Models Analysis|||3.5 hours postdose||0.39|-3.86|
71045466|NCT03465436|141599460|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-1.66|||||TWO_SIDED|90.0|-3.77|0.44|||Mixed Models Analysis|||4 hours postdose||0.44|-3.77|
71102591|NCT01217892|141713614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|3.132||0.001|TWO_SIDED|95.0|-16.5|-4.2||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c \<7.0% vs \>=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)||-4.2|-16.5|0.0010
71102592|NCT01217892|141713614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3|STANDARD_ERROR_OF_MEAN|3.139|<|0.0001|TWO_SIDED|95.0|-21.4|-9.1||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c \<7.0% vs \>=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)||-9.1|-21.4|<0.0001
71008337|NCT01258738|141524659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.8291|TWO_SIDED|95.0|-0.13|0.17|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.17|-0.13|0.8291
71045467|NCT03465436|141599460|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-1.11|||||TWO_SIDED|90.0|-3.17|0.94|||Mixed Models Analysis|||6 hours postdose||0.94|-3.17|
71045468|NCT03465436|141599460|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.47|||||TWO_SIDED|90.0|-4.58|-0.35|||Mixed Models Analysis|||8 hours postdose||-0.35|-4.58|
71045469|NCT03465436|141599460|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.15|||||TWO_SIDED|90.0|-3.87|-0.43|||Mixed Models Analysis|||12 hours postdose||-0.43|-3.87|
71045470|NCT03465436|141599460|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|0.79|||||TWO_SIDED|90.0|-1.14|2.72|||Mixed Models Analysis|||24 hours postdose||2.72|-1.14|
71045471|NCT03465436|141599460|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-4.64|||||TWO_SIDED|90.0|-6.57|-2.71|||Mixed Models Analysis|||30 minutes postdose||-2.71|-6.57|
71045472|NCT03465436|141599460|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.49|||||TWO_SIDED|90.0|-4.59|-0.39|||Mixed Models Analysis|||1 hour postdose||-0.39|-4.59|
71102593|NCT01217892|141713615|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.2|STANDARD_ERROR_OF_MEAN|6.097||0.0455|TWO_SIDED|95.0|0.2|24.1||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|Regression, Logistic|Methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||24.1|0.2|0.0455
71045473|NCT03465436|141599460|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.96|||||TWO_SIDED|90.0|-3.02|1.09|||Mixed Models Analysis|||1.5 hours postdose||1.09|-3.02|
71045474|NCT03465436|141599460|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|1.64|||||TWO_SIDED|90.0|-0.46|3.73|||Mixed Models Analysis|||2 hours postdose||3.73|-0.46|
71045475|NCT03465436|141599460|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|1.61|||||TWO_SIDED|90.0|-0.59|3.81|||Mixed Models Analysis|||2.5 hours postdose||3.81|-0.59|
71045476|NCT03465436|141599460|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|2.41|||||TWO_SIDED|90.0|0.25|4.57|||Mixed Models Analysis|||3 hours postdose||4.57|0.25|
71045477|NCT03465436|141599460|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|4.3|||||TWO_SIDED|90.0|2.48|6.12|||Mixed Models Analysis|||3.5 hours postdose||6.12|2.48|
71102594|NCT01217892|141713615|SUPERIORITY_OR_OTHER||Risk Difference (RD)|16.8|STANDARD_ERROR_OF_MEAN|6.153||0.0062|TWO_SIDED|95.0|4.8|28.9||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|Regression, Logistic|Methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||28.9|4.8|0.0062
71102595|NCT01905540|141713619|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The statistical comparison of log-transformed pharmacokinetic parameters between the single-dose treatment groups (Treatments AQ and SS) was based on the 90% CI for the ratio of the geometric means. If the 90% CI was entirely contained within the acceptance range of 0.8-1.25 then it was concluded that there was no statistically significant difference between treatments for the relevant parameter. Doses were normalized to the SSP-004184AQ (40mg/kg) dose prior to statistical analysis.|Ratio of geometric LS means|1.244|||||TWO_SIDED|90.0|1.081|1.43||||||||1.430|1.081|
71102596|NCT01905540|141713620|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The statistical comparison of log-transformed pharmacokinetic parameters between the single-dose treatment groups (Treatments AQ and SS) was based on the 90% CI for the ratio of the geometric means. If the 90% CI was entirely contained within the acceptance range of 0.8-1.25 then it was concluded that there was no statistically significant difference between treatments for the relevant parameter. Doses were normalized to the SSP-004184AQ (40mg/kg) dose prior to statistical analysis.|Geometric LS Means|1.233|||||TWO_SIDED|90.0|1.07|1.422||||||||1.422|1.070|
70925831|NCT03721952|141345306|SUPERIORITY||Slope|4.365|STANDARD_ERROR_OF_MEAN|6.987||0.533|TWO_SIDED|95.0|-9.367|18.097|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher number of hospital free days \& negative sign of estimate defined as lower number of hospital free days, for the intervention group vs. the control group.|Superior outcome for Group2 (Patient-Intervention)||18.097|-9.367|0.533
71045478|NCT03465436|141599460|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|5.15|||||TWO_SIDED|90.0|3.02|7.27|||Mixed Models Analysis|||4 hours postdose||7.27|3.02|
71045479|NCT03465436|141599460|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|2.77|||||TWO_SIDED|90.0|0.75|4.79|||Mixed Models Analysis|||6 hours postdose||4.79|0.75|
71045480|NCT03465436|141599460|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|1.75|||||TWO_SIDED|90.0|-0.55|4.05|||Mixed Models Analysis|||8 hours postdose||4.05|-0.55|
71045481|NCT03465436|141599460|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|1.75|||||TWO_SIDED|90.0|-0.19|3.69|||Mixed Models Analysis|||12 hours postdose||3.69|-0.19|
71045482|NCT03465436|141599460|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.48|||||TWO_SIDED|90.0|-2.44|1.48|||Mixed Models Analysis|||24 hours postdose||1.48|-2.44|
71045483|NCT03465436|141599460|SUPERIORITY||LS Mean|7.07|||||TWO_SIDED|90.0|4.72|9.41|||Mixed Models Analysis|||30 minutes postdose||9.41|4.72|
71045484|NCT03465436|141599460|SUPERIORITY||LS Mean|11.81|||||TWO_SIDED|90.0|9.94|13.69|||Mixed Models Analysis|||1 hour postdose||13.69|9.94|
71102597|NCT01905540|141713621|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The statistical comparison of log-transformed pharmacokinetic parameters between the single-dose treatment groups (Treatments AQ and SS) was based on the 90% CI for the ratio of the geometric means. If the 90% CI was entirely contained within the acceptance range of 0.8-1.25 then it was concluded that there was no statistically significant difference between treatments for the relevant parameter. Doses were normalized to the SSP-004184AQ (40mg/kg) dose prior to statistical analysis.|Ratio of geometric LS means|1.344|||||TWO_SIDED|90.0|1.135|1.592||||||||1.592|1.135|
71045485|NCT03465436|141599460|SUPERIORITY||LS Mean|10.95|||||TWO_SIDED|90.0|9.16|12.74|||Mixed Models Analysis|||1.5 hours postdose||12.74|9.16|
70925832|NCT03721952|141345307|SUPERIORITY||Slope|1.07|STANDARD_ERROR_OF_MEAN|1.07||0.318|TWO_SIDED|95.0|-1.032|3.173|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher number of ICU free days \& negative sign of estimate defined as lower number of ICU free days, for the intervention group vs. the control group.|Superior outcome for Group2 (Patient-Intervention)||3.173|-1.032|0.318
70925833|NCT03721952|141345308|SUPERIORITY||Slope|4.117|STANDARD_ERROR_OF_MEAN|3.506||0.241|TWO_SIDED|95.0|-2.773|11.007|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher number of ICU free days \& negative sign of estimate defined as lower number of ICU free days, for the intervention group vs. the control group.|Superior outcome for Group2 (Patient-Intervention)||11.007|-2.773|0.241
70925834|NCT03721952|141345309|SUPERIORITY||Slope|8.195|STANDARD_ERROR_OF_MEAN|7.466||0.273|TWO_SIDED|95.0|-6.479|22.868|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher number of ICU free days \& negative sign of estimate defined as lower number of ICU free days, for the intervention group vs. the control group.|Superior outcome for Group2 (Patient-Intervention)||22.868|-6.479|0.273
70925835|NCT03721952|141345310|SUPERIORITY||Slope|-0.0000009|STANDARD_ERROR_OF_MEAN|0.00000248||0.71|TWO_SIDED|95.0|-0.0000057|0.0000039|||other type of regression|Regression \[gamma family, link function g(u)=u-0.9\], outcome on random group (0=control, 1=intervention), adjusted for hospital, robust SEs.||Superior outcome for Group2 (Patient-Intervention)||0.0000039|-0.0000057|0.710
70925836|NCT03721952|141345311|SUPERIORITY||Slope|0.00000113|STANDARD_ERROR_OF_MEAN|0.00000215||0.599|TWO_SIDED|95.0|-0.000003|0.0000053|||other type of regression|Regression \[inverse Gaussian family, link function g(u)=u-0.9\], outcome on random group (0=control,1=intervention), adjusted for hospital, robust SEs.||Superior outcome for Group2 (Patient-Intervention)||0.0000053|-0.0000030|0.599
70925837|NCT03896789|141345369|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.95|TWO_SIDED|95.0|-3.3|3.5||The primary outcome was analyzed using a multi-level mixed-effects model, which included a random effect for site (to account for potential provider clustering) and fixed effects for covariates.|Mixed Models Analysis|Included covariates were age, gender, head maximum AIS, non-head maximum AIS, nurse: patient ratio and baseline TBI guideline adherence scores.||"Null hypothesis: Assuming no difference between usual care (control) and PEGASUS (intervention).~We used 2011-2012 results from prior pilot work in Argentina (58.6% TBI guideline adherence) to determine a sample size of 432 eligible patients (216 per arm) for the planned parallel cluster RCT, which would have 80% power to detect a 18.7% higher ICU TBI guideline adherence rate with programme implementation, with a two-sided alpha of 5%, and an intraclass coefficient of 0.05."||3.5|-3.3|.95
70925838|NCT03896789|141345375|SUPERIORITY||Mean Difference (Final Values)|7.9||||0.01|TWO_SIDED|95.0|1.9|13.8||The outcome was analyzed using a multi-level mixed-effects model, which included a random effect for site (to account for potential provider clustering) and fixed effects for covariates.|Mixed Models Analysis|Included covariates were age, gender, head maximum AIS, non-head maximum AIS, nurse: patient ratio and baseline TBI guideline adherence scores.||||13.8|1.9|.01
70925839|NCT01987895|141345386|NON_INFERIORITY|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above -10%.|Difference between 2 proportions|-1.4|||||TWO_SIDED|95.0|-7.2|4.3|||||CI for the difference between two proportions are estimated using the Wilson's score method|||4.3|-7.2|
70925840|NCT01987895|141345386|NON_INFERIORITY|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above -10%.|Difference between 2 proportions|-2.4|||||TWO_SIDED|95.0|-8.1|3.2|||||CI for the difference between two proportions are estimated using the Wilson's score method|Sensitivity analysis with imputation for a single day with missing UBM data between one day before end-of-treatment (EOT) and 2 days after EOT||3.2|-8.1|
70925841|NCT01987895|141345387|NON_INFERIORITY|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above -10%.|Difference between 2 proportions|-4.1|||||TWO_SIDED|95.0|-9.2|1.0|||||CI for the difference between two proportions are estimated using the Wilson' score method|||1.0|-9.2|
70925842|NCT01987895|141345388|SUPERIORITY|Superiority of cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above zero|Difference between 2 proportions|3.3|||||TWO_SIDED|95.0|-4.3|10.8|||||CI for the difference between two proportions are estimated using the Wilson's score method|||10.8|-4.3|
70925843|NCT01987895|141345389|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.6016|TWO_SIDED|95.0|0.8|1.14||two-sided p-value (alpha 5%) based on log-rank test stratified by first occurrence / first recurrence and geographical region.|Log Rank|||||1.14|0.80|0.6016
70925844|NCT01987895|141345390|SUPERIORITY||Least Square Mean difference|0.002||||0.9814|TWO_SIDED|95.0|-0.2|0.2||Two-sided 5% alpha level was used|ANOVA|ANOVA for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12.|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the diarrhea domain scores||0.20|-0.20|0.9814
71008338|NCT01258738|141524660|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
71008339|NCT01258738|141524660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.3536|TWO_SIDED|95.0|-0.64|0.23|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.23|-0.64|0.3536
71008340|NCT01258738|141524660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0769|TWO_SIDED|95.0|-0.97|0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.05|-0.97|0.0769
70925845|NCT01987895|141345390|SUPERIORITY||Least Square Mean difference|0.087||||0.2879|TWO_SIDED|95.0|-0.07|0.25||Two-sided 5% alpha level was used|ANOVA|ANOVA for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the abdominal symptoms domain scores||0.25|-0.07|0.2879
70925846|NCT01987895|141345390|SUPERIORITY||Least Square Mean difference|0.05||||0.488|TWO_SIDED|95.0|-0.09|0.19||Two-sided 5% alpha level was used|ANOVA|ANOVA for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the systemic / other symptoms domain scores||0.19|-0.09|0.4880
70925847|NCT01987895|141345391|OTHER||Difference between 2 proportions|-1.8|||||TWO_SIDED|95.0|-6.5|2.9|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis||2.9|-6.5|
70925848|NCT01987895|141345392|OTHER||Difference between 2 proportions|-1.9|||||TWO_SIDED|95.0|-6.2|2.3|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis||2.3|-6.2|
70925849|NCT01987895|141345393|OTHER||Difference between 2 proportions|3.7|||||TWO_SIDED|95.0|-3.4|10.7|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis||10.7|-3.4|
70925850|NCT01987895|141345394|OTHER|Sensitivity analysis|Difference between 2 proportions|1.1|||||TWO_SIDED|95.0|-6.5|8.7|||||CI for the difference between two proportions are estimated using the Wilson's score method|||8.7|-6.5|
70925851|NCT05364671|141345396|SUPERIORITY|||||||0.0088||||||A priori threshold for statistical significance is set to 0.04|Chi-squared|||||||0.0088
70925852|NCT05364671|141345397|SUPERIORITY|||||||0.0025||||||A priori threshold for statistical significance is set to 0.005|Wilcoxon (Mann-Whitney)|||Mean differences (Raphamin vs. Placebo) were compared||||0.0025
70925853|NCT05364671|141345399|SUPERIORITY|||||||0.2607|||||||Wilcoxon (Mann-Whitney)|||Mean differences (Raphamin vs. Placebo) were compared||||0.2607
70925854|NCT05364671|141345400|SUPERIORITY|||||||0.7601|||||||Fisher Exact|||"This analysis applies to Day 6 row."||||0.7601
70925855|NCT05364671|141345400|SUPERIORITY|||||||0.7685|||||||Fisher Exact|||"This analysis applies to Day 10 row."||||0.7685
70925856|NCT05364671|141345401|SUPERIORITY|||||||0.052|||||||Fisher Exact|||||||0.052
70925857|NCT05364671|141345402|SUPERIORITY|||||||0.19|||||||Fisher Exact|||||||0.19
70925858|NCT05364671|141345403|SUPERIORITY|||||||0.54|||||||Fisher Exact|||||||0.54
70925859|NCT05364671|141345404|SUPERIORITY|||||||0.1|||||||Fisher Exact|||||||0.10
70925860|NCT05364671|141345405|SUPERIORITY|||||||0.92||||||"The p-value associated with treatment\*visit interaction of pulse rate (heart rate) from Visit 1 to 4 between Raphamin and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.92
70925861|NCT05364671|141345406|SUPERIORITY|||||||0.44||||||"The p-value associated with treatment\*visit interaction of respiration rate (breathing rate) from Visit 1 to 4 between Raphamin and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.44
70925862|NCT05364671|141345407|SUPERIORITY|||||||0.9||||||"The p-value associated with treatment\*visit interaction of SpO2 from Visit 1 to 4 between Raphamin and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.90
71045486|NCT03465436|141599460|SUPERIORITY||LS Mean|11.5|||||TWO_SIDED|90.0|9.5|13.43|||Mixed Models Analysis|||2 hours postdose||13.43|9.5|
71045487|NCT03465436|141599460|SUPERIORITY||LS Mean|10.81|||||TWO_SIDED|90.0|8.9|12.71|||Mixed Models Analysis|||2.5 hours postdose||12.71|8.9|
71045488|NCT03465436|141599460|SUPERIORITY||LS Mean|12.35|||||TWO_SIDED|90.0|10.42|14.28|||Mixed Models Analysis|||3 hours postdose||14.28|10.42|
71045489|NCT03465436|141599460|SUPERIORITY||LS Mean|12.65|||||TWO_SIDED|90.0|10.76|14.54|||Mixed Models Analysis|||3.5 hours postdose||14.54|10.76|
71045490|NCT03465436|141599460|SUPERIORITY||LS Mean|11.17|||||TWO_SIDED|90.0|9.23|13.1|||Mixed Models Analysis|||4 hours postdose||13.10|9.23|
71045491|NCT03465436|141599460|SUPERIORITY||LS Mean|8.12|||||TWO_SIDED|90.0|6.02|10.22|||Mixed Models Analysis|||6 hours postdose||10.22|6.02|
71045492|NCT03465436|141599460|SUPERIORITY||LS Mean|8.1|||||TWO_SIDED|90.0|6.01|10.19|||Mixed Models Analysis|||8 hours postdose||10.19|6.01|
71045493|NCT03465436|141599460|SUPERIORITY||LS Mean|6.26|||||TWO_SIDED|90.0|4.23|8.28|||Mixed Models Analysis|||12 hours postdose||8.28|4.23|
71045494|NCT03465436|141599460|SUPERIORITY||LS Mean|5.74|||||TWO_SIDED|90.0|3.47|8.01|||Mixed Models Analysis|||24 hours postdose||8.01|3.47|
71045495|NCT03465436|141599461|SUPERIORITY||LS Mean|32.89|||||TWO_SIDED|90.0|11.5|54.28|||Mixed Models Analysis|||30 minutes postdose||54.28|11.50|
71045496|NCT03465436|141599461|SUPERIORITY||LS Mean|100.15|||||TWO_SIDED|90.0|77.81|122.5|||Mixed Models Analysis|||1 hour postdose||122.50|77.81|
71045497|NCT03465436|141599461|SUPERIORITY||LS Mean|107.11|||||TWO_SIDED|90.0|83.31|130.91|||Mixed Models Analysis|||1.5 hours postdose||130.91|83.31|
71045498|NCT03465436|141599461|SUPERIORITY||LS Mean|74.48|||||TWO_SIDED|90.0|56.32|92.63|||Mixed Models Analysis|||2 hours postdose||92.63|56.32|
71045499|NCT03465436|141599461|SUPERIORITY||LS Mean|89.19|||||TWO_SIDED|90.0|68.77|109.61|||Mixed Models Analysis|||2.5 hours postdose||109.61|68.77|
71045500|NCT03465436|141599461|SUPERIORITY||LS Mean|74.98|||||TWO_SIDED|90.0|55.41|94.55|||Mixed Models Analysis|||3 hours postdose||94.55|55.41|
71045501|NCT03465436|141599461|SUPERIORITY||LS Mean|52.83|||||TWO_SIDED|90.0|36.03|69.63|||Mixed Models Analysis|||3.5 hours postdose||69.63|36.03|
71045502|NCT03465436|141599461|SUPERIORITY||LS Mean|42.1|||||TWO_SIDED|90.0|24.86|59.35|||Mixed Models Analysis|||4 hours postdose||59.35|24.86|
71045503|NCT03465436|141599461|SUPERIORITY||LS Mean|62.61|||||TWO_SIDED|90.0|42.39|82.83|||Mixed Models Analysis|||6 hours postdose||82.83|42.39|
71045504|NCT03465436|141599461|SUPERIORITY||LS Mean|56.05|||||TWO_SIDED|90.0|32.49|79.61|||Mixed Models Analysis|||8 hours postdose||79.61|32.49|
71045505|NCT03465436|141599461|SUPERIORITY||LS Mean|35.71|||||TWO_SIDED|90.0|11.79|59.63|||Mixed Models Analysis|||12 hours postdose||59.63|11.79|
71045506|NCT03465436|141599461|SUPERIORITY||LS Mean|-4.59|||||TWO_SIDED|90.0|-24.66|15.47|||Mixed Models Analysis|||24 hours postdose||15.47|-24.66|
71045507|NCT03465436|141599461|SUPERIORITY||LS Mean|56.53|||||TWO_SIDED|90.0|36.72|76.35|||Mixed Models Analysis|||30 minutes postdose||76.35|36.72|
70925863|NCT05364671|141345408|SUPERIORITY|||||||0.3||||||"The p-value associated with treatment\*visit interaction of SBP from Visit 1 to 4 between Raphamin and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.30
70925864|NCT05364671|141345408|SUPERIORITY|||||||0.94||||||"The p-value associated with treatment\*visit interaction of DBP from Visit 1 to 4 between Raphamin and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.94
70925865|NCT02359890|141345410|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants with events|2.6|||||TWO_SIDED|95.0|0.7|6.5|||||The 2-sided 95% confidence interval is derived using the exact Clopper-Pearson interval.|||6.5|0.7|
70925866|NCT02359890|141345412|SUPERIORITY_OR_OTHER_LEGACY||Percentage of patient with acute success|96.2|||||TWO_SIDED|95.0|92.0|98.6|||||The 2-sided 95% confidence interval is derived using the exact Clopper-Pearson interval|||98.6|92.0|
70925867|NCT05256017|141345414|OTHER||Excess rate (ER)|-1.5|||||TWO_SIDED|95.0|-7.2|3.7||||||||3.7|-7.2|
70925868|NCT05256017|141345415|OTHER||Excess rate (ER)|-0.9|||||TWO_SIDED|95.0|-4.1|1.4|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|Occurrence and excess rate (95% CI) of any TEAEs (by PT, for PTs reported in ≥1% of participants in either arm) from the investigational product administration (Day 1) to the Month 4 follow-up visit.||1.4|-4.1|
70925869|NCT05256017|141345416|OTHER||Excess rate (ER)|0.4|||||TWO_SIDED|95.0|-1.6|1.6|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||1.6|-1.6|
70925870|NCT05256017|141345417|OTHER||Excess rate (ER)|-0.5|||||TWO_SIDED|95.0|-3.2|1.4|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||1.4|-3.2|
70925871|NCT05256017|141345418|OTHER||Excess rate (ER)|-0.6|||||TWO_SIDED|95.0|-2.6|0.6|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||0.6|-2.6|
70925872|NCT05256017|141345419|OTHER||Excess rate (ER)|-0.2|||||TWO_SIDED|95.0|-2.2|0.8|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||0.8|-2.2|
70925873|NCT05256017|141345420|OTHER||Excess rate (ER)|-0.3|||||TWO_SIDED|95.0|-2.3|0.7|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||0.7|-2.3|
70925874|NCT05256017|141345421|OTHER||Excess rate (ER)|3.2|||||TWO_SIDED|95.0|0.3|5.3|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||5.3|0.3|
70925875|NCT05256017|141345422|OTHER||Excess rate (ER)|-0.1|||||TWO_SIDED|95.0|-2.4|1.3|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||1.3|-2.4|
70925876|NCT05256017|141345423|OTHER||Excess rate (ER)|-1.1|||||TWO_SIDED|95.0|-3.5|0.3|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||0.3|-3.5|
70925877|NCT05256017|141345424|OTHER||Excess rate (ER)|1.0|||||TWO_SIDED|95.0|-3.7|5.1||||||Occurrence and excess rate (95% CI) of any TEAEs reported during hospitalization.||5.1|-3.7|
70925878|NCT05256017|141345424|OTHER||Excess rate (ER)|-3.3|||||TWO_SIDED|95.0|-8.2|0.9||||||Occurrence and excess rate (95% CI) of any TEAEs reported after the hospitalization period.||0.9|-8.2|
70925879|NCT05256017|141345425|OTHER||Excess rate (ER)|-1.0|||||TWO_SIDED|95.0|-3.1|0.0||||||||0.0|-3.1|
70925880|NCT05256017|141345426|OTHER||Excess rate (ER)|-1.5|||||TWO_SIDED|95.0|-7.2|3.7||||||Of note, all AEs reported during this study were TEAEs.||3.7|-7.2|
70925881|NCT05256017|141345444|OTHER||Placebo-corrected change from baseline|-0.4|||||TWO_SIDED|90.0|-2.1|1.4||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||1.4|-2.1|
70925882|NCT05256017|141345445|OTHER||Placebo-corrected change from baseline|-0.5|||||TWO_SIDED|90.0|-22.0|21.1||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||21.1|-22.0|
70925883|NCT05256017|141345446|OTHER||Placebo-corrected change from baseline|-1.1|||||TWO_SIDED|90.0|-3.6|1.3||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||1.3|-3.6|
70925884|NCT05256017|141345447|OTHER||Placebo-corrected change from baseline|-0.7|||||TWO_SIDED|90.0|-1.9|0.4||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||0.4|-1.9|
70925885|NCT05256017|141345448|OTHER||Placebo-corrected change from baseline|-10.9|||||TWO_SIDED|90.0|-15.3|-6.6||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||-6.6|-15.3|
70925886|NCT05256017|141345449|OTHER||Placebo-corrected change from baseline|-11.5|||||TWO_SIDED|90.0|-14.4|-8.7||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||-8.7|-14.4|
71102598|NCT02743962|141713639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75|STANDARD_DEVIATION|2.12|||TWO_SIDED|||||||||The control group reported a mean reduction in O'Leary-Sant Insterstitial Cystitis Symptom Score from baseline to 6 weeks that met the MCID (4 points), whereas the TW group reported a reduction of 1.5 times the MCID (ISCI score change: control group 4.25, + 0.95, TW group 6.2, + 0.83). From 6 to 12 weeks the control group reported no change in ISCI score (0 + 0.95) whereas the Therapeutic Wand group ISCI socre reduced by 1.8 +1.73.||||
71102599|NCT02743962|141713639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.25|STANDARD_DEVIATION|2.67|||TWO_SIDED|||||||||There was a small mean baseline ICPI score difference of 1.2 points between the groups (control group 10.5, +, TW group 11.2, + 2.68). Both groups reported a reduction in their ICPI scores from baseline to twelve weeks; the control group nearly met the minimal clinically important difference of 4 points and the TW group reported nearly twice the control group's score change (mean change control group 3.75, + 2.44, TW group 7, + 1.87).||||
71008341|NCT01258738|141524660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.4698|TWO_SIDED|95.0|-0.7|0.33|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.33|-0.70|0.4698
71045508|NCT03465436|141599461|SUPERIORITY||LS Mean|103.3|||||TWO_SIDED|90.0|83.88|122.72|||Mixed Models Analysis|||1 hour postdose||122.72|83.88|
71102600|NCT04330859|141713688|SUPERIORITY||Agresti-Caffo|95.0||||0.0543|TWO_SIDED|||||58.8 ± 7.2 (intervention) and 57.2 ± 11.2 (control; p = 0.0543)|t-test, 1 sided|||||||0.0543
71102601|NCT02014376|141713715|SUPERIORITY||||||=|0.3699|||||||Fisher Exact|||||||=0.3699
71045509|NCT03465436|141599461|SUPERIORITY||LS Mean|94.21|||||TWO_SIDED|90.0|75.15|113.26|||Mixed Models Analysis|||1.5 hours postdose||113.26|75.15|
71102602|NCT02951481|141713725|SUPERIORITY|||||||0.56|||||||Chi-squared|||||||0.56
71102603|NCT02951481|141713726|SUPERIORITY|||||||0.55|TWO_SIDED|95.0|||||Fisher Exact|||||||0.55
71102604|NCT02951481|141713727|SUPERIORITY|||||||0.023|||||||Chi-squared|||||||0.023
71102605|NCT02951481|141713728|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71008342|NCT01258738|141524660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.0167|TWO_SIDED|95.0|-1.19|-0.12|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.12|-1.19|0.0167
71102606|NCT02951481|141713729|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.5
71102607|NCT02951481|141713730|SUPERIORITY|||||||0.07|||||||Chi-squared|||||||0.07
71102608|NCT02951481|141713731|SUPERIORITY|||||||0.47|||||||Chi-squared|||||||0.47
71102609|NCT02951481|141713732|SUPERIORITY|||||||0.29|||||||Fisher Exact|||||||0.29
71102610|NCT01051661|141713733|SUPERIORITY|The non-inferiority objective was met if the lower limit (LL) of the 95% CI for the Vaccine Efficacy Improvement (VEI) was \> -33%. Furthermore, the superiority objective was met if the LL of the 95% CI for the VEI was \>0.|Vaccine efficacy increase|76.7|||||TWO_SIDED|95.0|18.53|93.39||||||Evaluation of the relative protective efficacy of 2 doses of Arepanrix™ vaccine (Arepanrix 2D Group) compared to two doses of GSK2340273A vaccine (GSK2340273A Group) beginning 14 days after Dose 1 vaccination (for each subject enrolled) and continuing until study conclusion on Day 385.||93.39|18.53|
71045510|NCT03465436|141599461|SUPERIORITY||LS Mean|83.49|||||TWO_SIDED|90.0|67.98|99.0|||Mixed Models Analysis|||2 hours postdose||99.00|67.98|
71045511|NCT03465436|141599461|SUPERIORITY||LS Mean|103.64|||||TWO_SIDED|90.0|87.28|120.0|||Mixed Models Analysis|||2.5 hours postdose||120.00|87.28|
71045512|NCT03465436|141599461|SUPERIORITY||LS Mean|89.26|||||TWO_SIDED|90.0|71.24|107.29|||Mixed Models Analysis|||3 hours postdose||107.29|71.24|
71102611|NCT01051661|141713761|OTHER||Adjusted GMT ratios|5.61|||||TWO_SIDED|95.0|4.92|6.41||||||Adjusted Geometric mean titer (GMT) ratios of Hemagglutination Inhibition (HI) antibody post vaccination between Arepanrix 2D Group and GSK2340273A Group for A/California influenza strain (Arepanrix 2D Group/GSK2340273A Group).||6.41|4.92|
71102612|NCT01051661|141713761|OTHER||Adjusted GMT ratios|1.05|||||TWO_SIDED|95.0|0.93|1.19||||||Adjusted Geometric mean titer (GMT) ratios of Hemagglutination Inhibition (HI) antibody post vaccination between Arepanrix 1D Group and GSK2340273A Group for A/California influenza strain (Arepanrix 1D Group/GSK2340273A Group).||1.19|0.93|
71045513|NCT03465436|141599461|SUPERIORITY||LS Mean|65.29|||||TWO_SIDED|90.0|48.28|82.3|||Mixed Models Analysis|||3.5 hours postdose||82.30|48.28|
71008343|NCT01258738|141524661|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Most within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71008344|NCT01258738|141524661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.02|||<|0.0001|TWO_SIDED|95.0|-4.39|-1.66|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-1.66|-4.39|<0.0001
71008345|NCT01258738|141524661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.86||||0.0008|TWO_SIDED|95.0|-6.09|-1.62|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-1.62|-6.09|0.0008
71008346|NCT01258738|141524661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.04||||0.0143|TWO_SIDED|95.0|-5.47|-0.61|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.61|-5.47|0.0143
71008347|NCT01258738|141524661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.12||||0.0038|TWO_SIDED|95.0|-5.23|-1.02|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-1.02|-5.23|0.0038
71008348|NCT01258738|141524662|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test||||<0.001
71008349|NCT01258738|141524662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.71|||<|0.0001|TWO_SIDED|95.0|-10.85|-4.58|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-4.58|-10.85|<0.0001
71008350|NCT01258738|141524662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.12|||<|0.0001|TWO_SIDED|95.0|-9.16|-3.09|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-3.09|-9.16|<0.0001
71008351|NCT01258738|141524662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.78||||0.0009|TWO_SIDED|95.0|-9.15|-2.41|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-2.41|-9.15|0.0009
71008352|NCT01258738|141524662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.03|||<|0.0001|TWO_SIDED|95.0|-10.34|-3.73|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-3.73|-10.34|<0.0001
71008353|NCT01258738|141524663|SUPERIORITY_OR_OTHER|||||||0.037|||||||t-test, 2 sided|||With the exception of change from Baseline in the placebo group at Week 12, within group comparisons to baseline for all other treatment groups and time points were \<0.001, from paired t-test.||||0.0370
71008354|NCT01258738|141524663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9965|TWO_SIDED|95.0|-4.39|4.37|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 4||4.37|-4.39|0.9965
71045514|NCT03465436|141599461|SUPERIORITY||LS Mean|52.85|||||TWO_SIDED|90.0|36.1|69.6|||Mixed Models Analysis|||4 hours postdose||69.60|36.10|
71045515|NCT03465436|141599461|SUPERIORITY||LS Mean|86.09|||||TWO_SIDED|90.0|66.36|105.82|||Mixed Models Analysis|||6 hours postdose||105.82|66.36|
71045516|NCT03465436|141599461|SUPERIORITY||LS Mean|80.12|||||TWO_SIDED|90.0|58.32|101.91|||Mixed Models Analysis|||8 hours postdose||101.91|58.32|
71008355|NCT01258738|141524663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.61||||0.197|TWO_SIDED|95.0|-1.89|9.1|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 8||9.10|-1.89|0.1970
71008356|NCT01258738|141524663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.07||||0.0394|TWO_SIDED|95.0|0.3|11.84|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 12||11.84|0.30|0.0394
71008357|NCT01258738|141524664|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.01 at Week 12 and \<0.001 thereafter, from paired t-test.||||<0.01
71008358|NCT01258738|141524664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.1341|TWO_SIDED|95.0|-0.02|0.21|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 4||0.21|-0.02|0.1341
71008359|NCT01258738|141524664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.0447|TWO_SIDED|95.0|0.0|0.14|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 8||0.14|0.00|0.0447
71045517|NCT03465436|141599461|SUPERIORITY||LS Mean|67.58|||||TWO_SIDED|90.0|44.64|90.51|||Mixed Models Analysis|||12 hours postdose||90.51|44.64|
71045518|NCT03465436|141599461|SUPERIORITY||LS Mean|7.77|||||TWO_SIDED|90.0|-10.01|25.55|||Mixed Models Analysis|||24 hours postdose||25.55|-10.01|
71045519|NCT03465436|141599461|SUPERIORITY||LS Mean|-22.02|||||TWO_SIDED|90.0|-38.44|-5.6|||Mixed Models Analysis|||30 minutes postdose||-5.60|-38.44|
71045520|NCT03465436|141599461|SUPERIORITY||LS Mean|-38.87|||||TWO_SIDED|90.0|-57.15|-20.6|||Mixed Models Analysis|||1 hour postdose||-20.60|-57.15|
71045521|NCT03465436|141599461|SUPERIORITY||LS Mean|-22.13|||||TWO_SIDED|90.0|-39.35|-4.91|||Mixed Models Analysis|||1.5 hours postdose||-4.91|-39.35|
71045522|NCT03465436|141599461|SUPERIORITY||LS Mean|-17.35|||||TWO_SIDED|90.0|-32.15|-2.56|||Mixed Models Analysis|||2 hours postdose||-2.56|-32.15|
71045523|NCT03465436|141599461|SUPERIORITY||LS Mean|-1.03|||||TWO_SIDED|90.0|-18.17|16.12|||Mixed Models Analysis|||2.5 hours postdose||16.12|-18.17|
71045524|NCT03465436|141599461|SUPERIORITY||LS Mean|-4.77|||||TWO_SIDED|90.0|-21.81|12.27|||Mixed Models Analysis|||3 hours postdose||12.27|-21.81|
71045525|NCT03465436|141599461|SUPERIORITY||LS Mean|-16.56|||||TWO_SIDED|90.0|-33.36|0.24|||Mixed Models Analysis|||3.5 hours postdose||0.24|-33.36|
71045526|NCT03465436|141599461|SUPERIORITY||LS Mean|-15.29|||||TWO_SIDED|90.0|-32.94|2.37|||Mixed Models Analysis|||4 hours postdose||2.37|-32.94|
71045527|NCT03465436|141599461|SUPERIORITY||LS Mean|6.13|||||TWO_SIDED|90.0|-10.86|23.11|||Mixed Models Analysis|||6 hours postdose||23.11|-10.86|
71045528|NCT03465436|141599461|SUPERIORITY||LS Mean|2.27|||||TWO_SIDED|90.0|-15.25|19.8|||Mixed Models Analysis|||8 hours postdose||19.80|-15.25|
71045529|NCT03465436|141599461|SUPERIORITY||LS Mean|-11.95|||||TWO_SIDED|90.0|-33.46|9.56|||Mixed Models Analysis|||12 hours postdose||9.56|-33.46|
71045530|NCT03465436|141599461|SUPERIORITY||LS Mean|-0.31|||||TWO_SIDED|90.0|-17.32|16.69|||Mixed Models Analysis|||24 hours postdose||16.69|-17.32|
71045531|NCT03465436|141599462|SUPERIORITY||LS Mean|0.02|||||TWO_SIDED|90.0|-0.37|0.41|||Mixed Models Analysis|||30 minutes postdose||0.41|-0.37|
71045532|NCT03465436|141599462|SUPERIORITY||LS Mean|-0.23|||||TWO_SIDED|90.0|-0.61|0.15|||Mixed Models Analysis|||1 hour postdose||0.15|-0.61|
71045533|NCT03465436|141599462|SUPERIORITY||LS Mean|-0.12|||||TWO_SIDED|90.0|-0.47|0.23|||Mixed Models Analysis|||1.5 hours postdose||0.23|-0.47|
71045534|NCT03465436|141599462|SUPERIORITY||LS Mean|-0.44|||||TWO_SIDED|90.0|-0.81|-0.07|||Mixed Models Analysis|||2 hours postdose||-0.07|-0.81|
71045535|NCT03465436|141599462|SUPERIORITY||LS Mean|-0.55|||||TWO_SIDED|90.0|-0.95|-0.15|||Mixed Models Analysis|||2.5 hours postdose||-0.15|-0.95|
71045536|NCT03465436|141599462|SUPERIORITY||LS Mean|-0.38|||||TWO_SIDED|90.0|-0.77|0.0|||Mixed Models Analysis|||3 hours postdose||0.00|-0.77|
71045537|NCT03465436|141599462|SUPERIORITY||LS Mean|-0.41|||||TWO_SIDED|90.0|-0.72|-0.1|||Mixed Models Analysis|||3.5 hours postdose||-0.10|-0.72|
70925887|NCT05256017|141345450|OTHER||Placebo-corrected change from baseline|-11.7|||||TWO_SIDED|90.0|-14.9|-8.6||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||-8.6|-14.9|
70925888|NCT05256017|141345451|OTHER||Estimate|-10.7|STANDARD_DEVIATION|1.72|||TWO_SIDED|90.0|-13.5|-7.85||||||Estimated ΔΔQTcF (in ms) computed from a concentration-response (C-R) model between dry blood spot concentration of acoziborole and changes from baseline in QTcF parameter||-7.85|-13.5|
71045538|NCT03465436|141599462|SUPERIORITY||LS Mean|-0.35|||||TWO_SIDED|90.0|-0.66|-0.04|||Mixed Models Analysis|||4 hours postdose||-0.04|-0.66|
71102613|NCT02412982|141713788|SUPERIORITY|||||||0.092|||||||Wilcoxon (Mann-Whitney)|||||||0.092
71102614|NCT04011241|141713826|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|173.71|||||TWO_SIDED|90.0|154.58|195.21|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|Intra-individual geometric coefficient of variation (gCV%) = 17.6.|||195.21|154.58|
70925889|NCT03536754|141345467|SUPERIORITY||LSM Ratio|1.23|STANDARD_ERROR_OF_MEAN|1.171||0.1924|TWO_SIDED|90.0|0.95|1.6||≤ 0.1924|Mixed effects model for repeated measure|||||1.6|0.95|0.1924
70925890|NCT03536754|141345467|SUPERIORITY||LSM Ratio|1.35|STANDARD_ERROR_OF_MEAN|1.172||0.0612|TWO_SIDED|90.0|1.04|1.76||≤ 0.0612|Mixed effects model for repeated measure|||||1.76|1.04|0.0612
71045539|NCT03465436|141599462|SUPERIORITY||LS Mean|-0.54|||||TWO_SIDED|90.0|-0.98|-0.09|||Mixed Models Analysis|||6 hours postdose||-0.09|-0.98|
71045540|NCT03465436|141599462|SUPERIORITY||LS Mean|-0.14|||||TWO_SIDED|90.0|-0.58|0.31|||Mixed Models Analysis|||8 hours postdose||0.31|-0.58|
71045541|NCT03465436|141599462|SUPERIORITY||LS Mean|-0.29|||||TWO_SIDED|90.0|-0.7|0.12|||Mixed Models Analysis|||12 hours postdose||0.12|-0.70|
71045542|NCT03465436|141599462|SUPERIORITY||LS Mean|0.43|||||TWO_SIDED|90.0|0.01|0.84|||Mixed Models Analysis|||24 hours postdose||0.84|0.01|
71045543|NCT03465436|141599462|SUPERIORITY||LS Mean|-0.19|||||TWO_SIDED|90.0|-0.59|0.21|||Mixed Models Analysis|||30 minutes postdose||0.21|-0.59|
71045544|NCT03465436|141599462|SUPERIORITY||LS Mean|0.48|||||TWO_SIDED|90.0|0.06|0.89|||Mixed Models Analysis|||1 hour postdose||0.89|0.06|
71045545|NCT03465436|141599462|SUPERIORITY||LS Mean|0.56|||||TWO_SIDED|90.0|0.19|0.93|||Mixed Models Analysis|||1.5 hours postdose||0.93|0.19|
71045546|NCT03465436|141599462|SUPERIORITY||LS Mean|0.4|||||TWO_SIDED|90.0|0.02|0.77|||Mixed Models Analysis|||2 hours postdose||0.77|0.02|
71045547|NCT03465436|141599462|SUPERIORITY||LS Mean|0.51|||||TWO_SIDED|90.0|0.13|0.88|||Mixed Models Analysis|||2.5 hours postdose||0.88|0.13|
71045548|NCT03465436|141599462|SUPERIORITY||LS Mean|0.33|||||TWO_SIDED|90.0|-0.05|0.71|||Mixed Models Analysis|||3 hours postdose||0.71|-0.05|
71045549|NCT03465436|141599462|SUPERIORITY||LS Mean|0.32|||||TWO_SIDED|90.0|-0.02|0.67|||Mixed Models Analysis|||3.5 hours postdose||0.67|-0.02|
71045550|NCT03465436|141599462|SUPERIORITY||LS Mean|0.5|||||TWO_SIDED|90.0|0.16|0.84|||Mixed Models Analysis|||4 hours postdose||0.84|0.16|
71045551|NCT03465436|141599462|SUPERIORITY||LS Mean|-0.1|||||TWO_SIDED|90.0|-0.56|0.36|||Mixed Models Analysis|||6 hours postdose||0.36|-0.56|
71045552|NCT03465436|141599462|SUPERIORITY||LS Mean|-0.11|||||TWO_SIDED|90.0|-0.56|0.33|||Mixed Models Analysis|||8 hours postdose||0.33|-0.56|
71045553|NCT03465436|141599462|SUPERIORITY||LS Mean|-0.39|||||TWO_SIDED|90.0|-0.84|0.06|||Mixed Models Analysis|||12 hours postdose||0.06|-0.84|
71045554|NCT03465436|141599462|SUPERIORITY||LS Mean|0.04|||||TWO_SIDED|90.0|-0.37|0.45|||Mixed Models Analysis|||24 hours postdose||0.45|-0.37|
71045555|NCT03465436|141599462|SUPERIORITY||LS Mean|-0.09|||||TWO_SIDED|90.0|-0.45|0.28|||Mixed Models Analysis|||30 minutes postdose||0.28|-0.45|
71045556|NCT03465436|141599462|SUPERIORITY||LS Mean|-0.1|||||TWO_SIDED|90.0|-0.46|0.27|||Mixed Models Analysis|||1 hour postdose||0.27|-0.46|
71045557|NCT03465436|141599462|SUPERIORITY||LS Mean|0.25|||||TWO_SIDED|90.0|-0.1|0.6|||Mixed Models Analysis|||1.5 hours postdose||0.60|-0.10|
71045558|NCT03465436|141599462|SUPERIORITY||LS Mean|0.01|||||TWO_SIDED|90.0|-0.38|0.4|||Mixed Models Analysis|||2 hours postdose||0.40|-0.38|
71045559|NCT03465436|141599462|SUPERIORITY||LS Mean|0.02|||||TWO_SIDED|90.0|-0.34|0.37|||Mixed Models Analysis|||2.5 hours postdose||0.37|-0.34|
71045560|NCT03465436|141599462|SUPERIORITY||LS Mean|-0.09|||||TWO_SIDED|90.0|-0.44|0.25|||Mixed Models Analysis|||3 hours postdose||0.25|-0.44|
71045561|NCT03465436|141599462|SUPERIORITY||LS Mean|-0.39|||||TWO_SIDED|90.0|-0.76|-0.03|||Mixed Models Analysis|||3.5 hours postdose||-0.03|-0.76|
71045562|NCT03465436|141599462|SUPERIORITY||LS Mean|-0.38|||||TWO_SIDED|90.0|-0.73|-0.03|||Mixed Models Analysis|||4 hours postdose||-0.03|-0.73|
71045563|NCT03465436|141599462|SUPERIORITY||LS Mean|-0.6|||||TWO_SIDED|90.0|-1.03|-0.17|||Mixed Models Analysis|||6 hours postdose||-0.17|-1.03|
71045564|NCT03465436|141599462|SUPERIORITY||LS Mean|-0.39|||||TWO_SIDED|90.0|-0.82|0.04|||Mixed Models Analysis|||8 hours postdose||0.04|-0.82|
71008360|NCT01258738|141524664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.1345|TWO_SIDED|95.0|-0.02|0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 12||0.13|-0.02|0.1345
71008361|NCT01258738|141524665|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
71008362|NCT01258738|141524665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.31||||0.1035|TWO_SIDED|95.0|-0.27|2.9|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4||2.90|-0.27|0.1035
71008363|NCT01258738|141524665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.38||||0.0134|TWO_SIDED|95.0|0.5|4.26|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12||4.26|0.50|0.0134
71008364|NCT01258738|141524666|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.05, from paired t-test.||||<0.05
71008365|NCT01258738|141524666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.18||||0.252|TWO_SIDED|95.0|-0.84|3.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4||3.19|-0.84|0.2520
71008366|NCT01258738|141524666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.4981|TWO_SIDED|95.0|-1.63|3.34|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12||3.34|-1.63|0.4981
71045565|NCT03465436|141599462|SUPERIORITY||LS Mean|-0.31|||||TWO_SIDED|90.0|-0.7|0.09|||Mixed Models Analysis|||12 hours postdose||0.09|-0.70|
71045566|NCT03465436|141599462|SUPERIORITY||LS Mean|0.19|||||TWO_SIDED|90.0|-0.23|0.61|||Mixed Models Analysis|||24 hours postdose||0.61|-0.23|
71045567|NCT03465436|141599463|SUPERIORITY||LS Mean|-1.53|||||TWO_SIDED|90.0|-2.9|-0.16|||Mixed Models Analysis|||30 minutes postdose||-0.16|-2.90|
71045568|NCT03465436|141599463|SUPERIORITY||LS Mean|-5.09|||||TWO_SIDED|90.0|-6.29|-3.88|||Mixed Models Analysis|||1 hour postdose||-3.88|-6.29|
71045569|NCT03465436|141599463|SUPERIORITY||LS Mean|-5.57|||||TWO_SIDED|90.0|-6.81|-4.32|||Mixed Models Analysis|||1.5 hours postdose||-4.32|-6.81|
71045570|NCT03465436|141599463|SUPERIORITY||LS Mean|-4.01|||||TWO_SIDED|90.0|-5.0|-3.01|||Mixed Models Analysis|||2 hours postdose||-3.01|-5.00|
71045571|NCT03465436|141599463|SUPERIORITY||LS Mean|-4.78|||||TWO_SIDED|90.0|-5.91|-3.65|||Mixed Models Analysis|||2.5 hours postdose||-3.65|-5.91|
71045572|NCT03465436|141599463|SUPERIORITY||LS Mean|-4.14|||||TWO_SIDED|90.0|-5.2|-3.08|||Mixed Models Analysis|||3 hours postdose||-3.08|-5.20|
71045573|NCT03465436|141599463|SUPERIORITY||LS Mean|-2.94|||||TWO_SIDED|90.0|-3.87|-2.01|||Mixed Models Analysis|||3.5 hours postdose||-2.01|-3.87|
71008367|NCT01258738|141524667|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
71045574|NCT03465436|141599463|SUPERIORITY||LS Mean|-2.42|||||TWO_SIDED|90.0|-3.42|-1.42|||Mixed Models Analysis|||4 hours postdose||-1.42|-3.42|
71008368|NCT01258738|141524667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.4621|TWO_SIDED|95.0|-0.9|0.41|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4||0.41|-0.90|0.4621
71008369|NCT01258738|141524667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.3842|TWO_SIDED|95.0|-1.28|0.5|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12||0.50|-1.28|0.3842
71045575|NCT03465436|141599463|SUPERIORITY||LS Mean|-4.61|||||TWO_SIDED|90.0|-6.17|-3.06|||Mixed Models Analysis|||6 hours postdose||-3.06|-6.17|
71045576|NCT03465436|141599463|SUPERIORITY||LS Mean|-3.82|||||TWO_SIDED|90.0|-5.38|-2.26|||Mixed Models Analysis|||8 hours postdose||-2.26|-5.38|
71045577|NCT03465436|141599463|SUPERIORITY||LS Mean|-2.65|||||TWO_SIDED|90.0|-4.33|-0.97|||Mixed Models Analysis|||12 hours postdose||-0.97|-4.33|
71045578|NCT03465436|141599463|SUPERIORITY||LS Mean|0.12|||||TWO_SIDED|90.0|-1.22|1.46|||Mixed Models Analysis|||24 hours postdose||1.46|-1.22|
71045579|NCT03465436|141599463|SUPERIORITY||LS Mean|-3.09|||||TWO_SIDED|90.0|-4.16|-2.02|||Mixed Models Analysis|||30 minutes postdose||-2.02|-4.16|
71045580|NCT03465436|141599463|SUPERIORITY||LS Mean|-5.61|||||TWO_SIDED|90.0|-6.65|-4.58|||Mixed Models Analysis|||1 hour postdose||-4.58|-6.65|
71045581|NCT03465436|141599463|SUPERIORITY||LS Mean|-5.39|||||TWO_SIDED|90.0|-6.42|-4.35|||Mixed Models Analysis|||1.5 hours postdose||-4.35|-6.42|
71045582|NCT03465436|141599463|SUPERIORITY||LS Mean|-4.64|||||TWO_SIDED|90.0|-5.55|-3.72|||Mixed Models Analysis|||2 hours postdose||-3.72|-5.55|
71045583|NCT03465436|141599463|SUPERIORITY||LS Mean|-5.82|||||TWO_SIDED|90.0|-6.77|-4.87|||Mixed Models Analysis|||2.5 hours postdose||-4.87|-6.77|
71045584|NCT03465436|141599463|SUPERIORITY||LS Mean|-4.99|||||TWO_SIDED|90.0|-6.03|-3.96|||Mixed Models Analysis|||3 hours postdose||-3.96|-6.03|
71045585|NCT03465436|141599463|SUPERIORITY||LS Mean|-3.69|||||TWO_SIDED|90.0|-4.68|-2.71|||Mixed Models Analysis|||3.5 hours postdose||-2.71|-4.68|
71045586|NCT03465436|141599463|SUPERIORITY||LS Mean|-3.19|||||TWO_SIDED|90.0|-4.21|-2.17|||Mixed Models Analysis|||4 hours postdose||-2.17|-4.21|
71045587|NCT03465436|141599463|SUPERIORITY||LS Mean|-6.29|||||TWO_SIDED|90.0|-7.83|-4.95|||Mixed Models Analysis|||6 hours postdose||-4.95|-7.83|
71045588|NCT03465436|141599463|SUPERIORITY||LS Mean|-5.37|||||TWO_SIDED|90.0|-6.73|-4.02|||Mixed Models Analysis|||8 hours postdose||-4.02|-6.73|
71045589|NCT03465436|141599463|SUPERIORITY||LS Mean|-4.71|||||TWO_SIDED|90.0|-6.25|-3.17|||Mixed Models Analysis|||12 hours postdose||-3.17|-6.25|
71045590|NCT03465436|141599463|SUPERIORITY||LS Mean|-0.55|||||TWO_SIDED|90.0|-1.74|0.63|||Mixed Models Analysis|||24 hours postdose||0.63|-1.74|
71045591|NCT03465436|141599463|SUPERIORITY||LS Mean|1.32|||||TWO_SIDED|90.0|0.32|2.33|||Mixed Models Analysis|||30 minutes postdose||2.33|0.32|
71045592|NCT03465436|141599463|SUPERIORITY||LS Mean|2.29|||||TWO_SIDED|90.0|1.19|3.4|||Mixed Models Analysis|||1 hour postdose||3.40|1.19|
71008370|NCT01258738|141524668|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
71008371|NCT01258738|141524668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.6357|TWO_SIDED|95.0|-0.52|0.86|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4||0.86|-0.52|0.6357
71008372|NCT01258738|141524668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.2439|TWO_SIDED|95.0|-1.39|0.36|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12||0.36|-1.39|0.2439
71008373|NCT01258738|141524669|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
71008374|NCT01258738|141524669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.3286|TWO_SIDED|95.0|-1.55|0.52|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Descriptive analysis was carried out for Week 12 data only.||0.52|-1.55|0.3286
71008375|NCT01258738|141524670|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
71008376|NCT01258738|141524670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.1829|TWO_SIDED|95.0|-1.93|0.37|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.||0.37|-1.93|0.1829
71008377|NCT01258738|141524671|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.05, from paired t-test.||||<0.05
71008378|NCT01258738|141524671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.37||||0.5226|TWO_SIDED|95.0|-4.95|9.68|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||9.68|-4.95|0.5226
71008379|NCT01258738|141524671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.62||||0.6232|TWO_SIDED|95.0|-4.9|8.14|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||8.14|-4.90|0.6232
71008380|NCT01258738|141524671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.52||||0.3877|TWO_SIDED|95.0|-4.53|11.57|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||11.57|-4.53|0.3877
71008381|NCT01258738|141524671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.74||||0.2402|TWO_SIDED|95.0|-3.22|12.69|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||12.69|-3.22|0.2402
71008382|NCT01258738|141524672|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001 at Week 16 and thereafter, from paired t-test.||||<0.001
71008383|NCT01258738|141524672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.19||||0.0193|TWO_SIDED|95.0|-16.85|-1.52|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-1.52|-16.85|0.0193
71008384|NCT01258738|141524672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.08||||0.173|TWO_SIDED|95.0|-12.41|2.26|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||2.26|-12.41|0.1730
71008385|NCT01258738|141524672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.26||||0.1224|TWO_SIDED|95.0|-14.23|1.71|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||1.71|-14.23|0.1224
71008386|NCT01258738|141524672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.14||||0.0461|TWO_SIDED|95.0|-18.11|-0.16|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.16|-18.11|0.0461
71008387|NCT01258738|141524673|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
71008388|NCT01258738|141524673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.97||||0.0372|TWO_SIDED|95.0|-11.58|-0.36|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.36|-11.58|0.0372
71008389|NCT01258738|141524673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1||||0.2126|TWO_SIDED|95.0|-7.98|1.79|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||1.79|-7.98|0.2126
71008390|NCT01258738|141524673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.66||||0.033|TWO_SIDED|95.0|-12.79|-0.54|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.54|-12.79|0.0330
71008391|NCT01258738|141524673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.85||||0.0397|TWO_SIDED|95.0|-13.38|-0.33|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.33|-13.38|0.0397
71008392|NCT01258738|141524674|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001 at Week 16 and at Week 32 and thereafter, from paired t test.||||<0.001
71008393|NCT01258738|141524674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.29||||0.0382|TWO_SIDED|95.0|-16.12|-0.46|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.46|-16.12|0.0382
71008394|NCT01258738|141524674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.25||||0.1648|TWO_SIDED|95.0|-12.69|2.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||2.19|-12.69|0.1648
71008395|NCT01258738|141524674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.98||||0.1476|TWO_SIDED|95.0|-14.11|2.15|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||2.15|-14.11|0.1476
71045593|NCT03465436|141599463|SUPERIORITY||LS Mean|1.3|||||TWO_SIDED|90.0|0.31|2.28|||Mixed Models Analysis|||1.5 hours postdose||2.28|0.31|
71045594|NCT03465436|141599463|SUPERIORITY||LS Mean|1.07|||||TWO_SIDED|90.0|0.17|1.97|||Mixed Models Analysis|||2 hours postdose||1.97|0.17|
71045595|NCT03465436|141599463|SUPERIORITY||LS Mean|0.21|||||TWO_SIDED|90.0|-0.81|1.23|||Mixed Models Analysis|||2.5 hours postdose||1.23|-0.81|
71045596|NCT03465436|141599463|SUPERIORITY||LS Mean|0.53|||||TWO_SIDED|90.0|-0.5|1.56|||Mixed Models Analysis|||3 hours postdose||1.56|-0.50|
71045597|NCT03465436|141599463|SUPERIORITY||LS Mean|1.36|||||TWO_SIDED|90.0|0.29|2.44|||Mixed Models Analysis|||3.5 hours postdose||2.44|0.29|
71045598|NCT03465436|141599463|SUPERIORITY||LS Mean|1.21|||||TWO_SIDED|90.0|0.09|2.34|||Mixed Models Analysis|||4 hours postdose||2.34|0.09|
71045599|NCT03465436|141599463|SUPERIORITY||LS Mean|-0.49|||||TWO_SIDED|90.0|-1.97|0.99|||Mixed Models Analysis|||6 hours postdose||0.99|-1.97|
71008396|NCT01258738|141524674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.68||||0.0687|TWO_SIDED|95.0|-18.03|0.68|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.68|-18.03|0.0687
71008397|NCT01258738|141524675|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
71045600|NCT03465436|141599463|SUPERIORITY||LS Mean|-0.36|||||TWO_SIDED|90.0|-1.54|0.83|||Mixed Models Analysis|||8 hours postdose||0.83|-1.54|
71045601|NCT03465436|141599463|SUPERIORITY||LS Mean|0.73|||||TWO_SIDED|90.0|-0.87|2.34|||Mixed Models Analysis|||12 hours postdose||2.34|-0.87|
71008398|NCT01258738|141524675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.2578|TWO_SIDED|95.0|-1.21|0.33|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4||0.33|-1.21|0.2578
71045602|NCT03465436|141599463|SUPERIORITY||LS Mean|-0.12|||||TWO_SIDED|90.0|-1.29|1.04|||Mixed Models Analysis|||24 hours postdose||1.04|-1.29|
71045603|NCT02697773|141599467|SUPERIORITY|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.24||0.0129|TWO_SIDED|95.0|-1.07|-0.13||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.13|-1.07|0.0129
71045604|NCT02697773|141599467|SUPERIORITY|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.24||0.0023|TWO_SIDED|95.0|-1.2|-0.26||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.26|-1.20|0.0023
71102615|NCT04011241|141713827|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|137.4|||||TWO_SIDED|90.0|120.84|156.24|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|Intra-individual geometric coefficient of variation (gCV%) = 19.4.|||156.24|120.84|
71102616|NCT04011241|141713828|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|168.64|||||TWO_SIDED|90.0|145.59|195.34|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|Intra-individual geometric coefficient of variation (gCV%) = 18.1.|||195.34|145.59|
71102617|NCT04875533|141713840|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.78|||||TWO_SIDED|95.0|0.66|0.92||||||Serotype 1: the ratio of GMT (GMR) (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.92|0.66|
71102618|NCT04875533|141713840|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.89|||||TWO_SIDED|95.0|0.79|0.99||||||Serotype 3: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.99|0.79|
71008399|NCT01258738|141524675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.4334|TWO_SIDED|95.0|-1.21|0.52|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12||0.52|-1.21|0.4334
70925891|NCT03536754|141345467|SUPERIORITY||LSM Ratio|1.05|STANDARD_ERROR_OF_MEAN|1.169||0.7653|TWO_SIDED|90.0|0.81|1.36||≤ 0.7653|Mixed effects model for repeated measure|||||1.36|0.81|0.7653
71008400|NCT01258738|141524676|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
71008401|NCT01258738|141524676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.3554|TWO_SIDED|95.0|-4.7|1.7|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4||1.70|-4.70|0.3554
71008402|NCT01258738|141524676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.91||||0.335|TWO_SIDED|95.0|-5.82|1.99|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12||1.99|-5.82|0.3350
71008403|NCT01258738|141524677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.41||||14.41|TWO_SIDED|95.0|0.04|28.78|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Descriptive analysis was carried out for Week 12 data only.||28.78|0.04|14.41
71008404|NCT01258738|141524678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.03||||0.1285|TWO_SIDED|95.0|-2.51|24.56|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Descriptive analysis was carried out for Week 12 data only.||24.56|-2.51|0.1285
71008405|NCT00568399|141524681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.2|STANDARD_DEVIATION|0.987||0.001|TWO_SIDED|95.0||||Coronary calcium score after treatment compared to baseline|Wilcoxon (Mann-Whitney)|||This was a pilot study without a control group. There were no power calculations (see manuscript).||||0.001
71008406|NCT03018028|141524682|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.8||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide 3 mg - Placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.8|-1.4|<0.0001
71008407|NCT03018028|141524682|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-1.5|||<|0.0001|TWO_SIDED|95.0|-1.7|-1.2||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide 7 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.2|-1.7|<0.0001
71008408|NCT03018028|141524682|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.0|-1.4||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.4|-2.0|<0.0001
71008697|NCT02055976|141525243|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.065|STANDARD_ERROR_OF_MEAN|1.843||0.004|TWO_SIDED|95.0|1.402|8.728|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||8.728|1.402|0.004
71008409|NCT03018028|141524682|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|0.3||||0.0799|TWO_SIDED|95.0|0.0|0.6||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide 3 mg - Liraglutide 0.9 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||0.6|-0.0|0.0799
71008410|NCT03018028|141524682|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-0.1||||0.3942|TWO_SIDED|95.0|-0.4|0.2||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide 7 mg - Liraglutide 0.9 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||0.2|-0.4|0.3942
71008411|NCT03018028|141524682|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-0.3||||0.0272|TWO_SIDED|95.0|-0.6|0.0||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurement||Oral semaglutide 14 mg - Liraglutide 0.9 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.0|-0.6|0.0272
71008412|NCT03018028|141524682|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.5||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 3 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.5|-1.1|<0.0001
71008413|NCT03018028|141524682|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.9||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 7 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.9|-1.5|<0.0001
71008414|NCT03018028|141524682|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.7|-1.1||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-1.1|-1.7|<0.0001
71008415|NCT03018028|141524682|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|0.2||||0.1958|TWO_SIDED|95.0|-0.1|0.5||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 3 mg - Liraglutide 0.9 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.5|-0.1|0.1958
71008698|NCT02055976|141525243|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.096|STANDARD_ERROR_OF_MEAN|1.853||0.004|TWO_SIDED|95.0|1.413|8.78|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||8.780|1.413|0.004
71102619|NCT04875533|141713840|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.79|||||TWO_SIDED|95.0|0.67|0.94||||||Serotype 4: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.94|0.67|
71008416|NCT03018028|141524682|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.2||||0.1868|TWO_SIDED|95.0|-0.5|0.1||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 7 mg - Liraglutide 0.9 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.1|-0.5|0.1868
71008417|NCT03018028|141524682|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.4||||0.0077|TWO_SIDED|95.0|-0.7|-0.1||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 14 mg - Liraglutide 0.9 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.1|-0.7|0.0077
71008418|NCT03018028|141524709|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.63||||0.2579|TWO_SIDED|95.0|0.29|1.4||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 3 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.40|0.29|0.2579
71008419|NCT03018028|141524709|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.25||||0.0052|TWO_SIDED|95.0|0.1|0.66||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 7 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.66|0.10|0.0052
71008420|NCT03018028|141524709|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.31||||0.0259|TWO_SIDED|95.0|0.11|0.87||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.87|0.11|0.0259
71008421|NCT03018028|141524709|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|2.7||||0.0674|TWO_SIDED|95.0|0.93|7.8||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 3 mg / Liraglutide 0.9 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||7.80|0.93|0.0674
71008422|NCT03018028|141524709|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.07||||0.9087|TWO_SIDED|95.0|0.32|3.54||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 7 mg / Liraglutide 0.9 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||3.54|0.32|0.9087
71008423|NCT03018028|141524709|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.33||||0.6498|TWO_SIDED|95.0|0.38|4.62||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Liraglutide 0.9 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||4.62|0.38|0.6498
71008424|NCT03018028|141524710|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.34||||0.0219|TWO_SIDED|95.0|0.14|0.86||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 3 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.86|0.14|0.0219
70941318|NCT00577096|141383060|NON_INFERIORITY_OR_EQUIVALENCE|T-test and chi-squared to check for equivalence of groups for age, race and gender.|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis was that there would be no difference between groups for the number of days of stem cell collections.||||<0.025
71008852|NCT02194699|141525390|SUPERIORITY||LS Mean difference|3.37||||0.1276|TWO_SIDED|95.0|-0.97|7.7|||Repeated measures analysis||Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of % change from baseline in pre-dose/pre-BD FEV1 at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis on patients with a baseline pre-dose/pre-BD FEV1 assessment.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||7.70|-0.97|0.1276
71008853|NCT02194699|141525390|SUPERIORITY||LS Mean difference|2.95||||0.1164|TWO_SIDED|95.0|-0.73|6.62|||Repeated measures analysis||Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of % change from baseline in pre-dose/pre-BD FEV1 at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis on patients with a baseline pre-dose/pre-BD FEV1 assessment||6.62|-0.73|0.1164
71008854|NCT02194699|141525391|SUPERIORITY||LS Mean difference|-0.2||||0.1456|TWO_SIDED|95.0|-0.47|0.07|||Repeated measures analysis||Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in total asthma symptom score at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||0.07|-0.47|0.1456
71008855|NCT02194699|141525391|SUPERIORITY||LS Mean difference|0.04||||0.6548|TWO_SIDED|95.0|-0.13|0.2|||Repeated measures analysis||Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in total asthma symptom score at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||0.20|-0.13|0.6548
71008856|NCT02194699|141525391|SUPERIORITY||LS Mean difference|-0.04||||0.5763|TWO_SIDED|95.0|-0.18|0.1|||Repeated measures analysis||Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of mean change from baseline in total asthma symptom score at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||0.10|-0.18|0.5763
71008857|NCT02194699|141525392|SUPERIORITY||LS Mean difference|0.27||||0.0874|TWO_SIDED|95.0|-0.04|0.57|||Repeated measures analysis||Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||0.57|-0.04|0.0874
71008858|NCT02194699|141525392|SUPERIORITY||LS Mean difference|-0.01||||0.9083|TWO_SIDED|95.0|-0.2|0.17|||Repeated measures analysis||Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||0.17|-0.20|0.9083
71008859|NCT02194699|141525392|SUPERIORITY||LS Mean difference|0.06||||0.4506|TWO_SIDED|95.0|-0.1|0.22|||Repeated measures analysis||Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||0.22|-0.10|0.4506
71045608|NCT02697773|141599469|SUPERIORITY|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.09||0.0038|TWO_SIDED|95.0|-0.41|-0.08||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.08|-0.41|0.0038
71077841|NCT02913105|141664395|OTHER|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|1.01||||0.9514|TWO_SIDED|90.0|0.84|1.21|||ANCOVA|||||1.21|0.84|0.9514
71008860|NCT02194699|141525393|SUPERIORITY||LS Mean difference|-0.27||||0.04|TWO_SIDED|95.0|-0.53|-0.01|||Repeated measures analysis||Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for ACQ-6 at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||-0.01|-0.53|0.0400
71008861|NCT02194699|141525393|SUPERIORITY||LS Mean difference|0.0||||0.9735|TWO_SIDED|95.0|-0.16|0.16|||Repeated measures analysis||Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for ACQ-6 at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||0.16|-0.16|0.9735
71008862|NCT02194699|141525393|SUPERIORITY||LS Mean difference|-0.08||||0.2432|TWO_SIDED|95.0|-0.21|0.05|||Repeated measures analysis||Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of change in mean score from baseline for ACQ-6 at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||0.05|-0.21|0.2432
71008863|NCT02194699|141525394|SUPERIORITY||Rate ratio|0.39||||0.0576|TWO_SIDED|95.0|0.15|1.03|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.|"Comparison of AAER associated with an ER/UC visit or hospitalisation: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model."||1.03|0.15|0.0576
71008864|NCT02194699|141525394|SUPERIORITY||Rate ratio|0.83||||0.5249|TWO_SIDED|95.0|0.46|1.48|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.|"Comparison of AAER associated with an ER/UC visit or hospitalisation: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model."||1.48|0.46|0.5249
71008865|NCT02194699|141525394|SUPERIORITY||Rate ratio|0.67||||0.1155|TWO_SIDED|95.0|0.41|1.1|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.|Comparison of AAER associated with an ER/UC visit or hospitalisation: FAS population; Tralo 300 mg Q2W vs placebo.||1.10|0.41|0.1155
71008866|NCT02194699|141525396|SUPERIORITY||LS Mean difference|-0.95||||0.036|TWO_SIDED|95.0|-1.85|-0.06|||Repeated measures analysis||Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in rescue medication use at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||-0.06|-1.85|0.0360
71008867|NCT02194699|141525396|SUPERIORITY||LS Mean difference|0.15||||0.5864|TWO_SIDED|95.0|-0.4|0.7|||Repeated measures analysis||Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in rescue medication use at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||0.70|-0.40|0.5864
71008868|NCT02194699|141525396|SUPERIORITY||LS Mean difference|-0.17||||0.4689|TWO_SIDED|95.0|-0.63|0.29|||Repeated measures analysis||Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of mean change from baseline in rescue medication use at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||0.29|-0.63|0.4689
71045609|NCT02697773|141599470|SUPERIORITY||Least Square Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.21||0.002|TWO_SIDED|95.0|-1.08|-0.24|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.24|-1.08|0.0020
71045610|NCT02697773|141599470|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.21||0.0014|TWO_SIDED|95.0|-1.1|-0.26|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.26|-1.10|0.0014
71117586|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.84||||0.616|TWO_SIDED|95.0|-8.3|13.98||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.98|-8.30|0.616
71008869|NCT02194699|141525397|SUPERIORITY||LS Mean difference|6.15||||0.5094|TWO_SIDED|95.0|-12.13|24.43|||Repeated measures analysis||Fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in morning PEF at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||24.43|-12.13|0.5094
71008870|NCT02194699|141525397|SUPERIORITY||LS Mean difference|3.02||||0.5984|TWO_SIDED|95.0|-8.22|14.26|||Repeated measures analysis||Fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in morning PEF at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||14.26|-8.22|0.5984
71008871|NCT02194699|141525397|SUPERIORITY||LS Mean difference|7.84||||0.3971|TWO_SIDED|95.0|-10.32|26.0|||Repeated measures analysis||Model included fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as fixed covariate.|"Comparison of mean change from baseline in evening PEF at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||26.00|-10.32|0.3971
71008872|NCT02194699|141525397|SUPERIORITY||LS Mean difference|3.59||||0.531|TWO_SIDED|95.0|-7.65|14.83|||Repeated measures analysis||Model included fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as fixed covariate.|"Comparison of mean change from baseline in evening PEF at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||14.83|-7.65|0.5310
71008873|NCT02194699|141525397|SUPERIORITY||LS Mean difference|3.46||||0.4764|TWO_SIDED|95.0|-6.06|12.97|||Repeated measures analysis||Model included fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as fixed covariate.|Comparison of mean change from baseline in morning PEF at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||12.97|-6.06|0.4764
71008874|NCT02194699|141525397|SUPERIORITY||LS Mean difference|3.88||||0.4221|TWO_SIDED|95.0|-5.6|13.37|||Repeated measures analysis||Model included fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as fixed covariate.|Comparison of mean change from baseline in evening PEF at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||13.37|-5.60|0.4221
71008875|NCT02194699|141525398|SUPERIORITY||LS Mean difference|-5.04||||0.1099|TWO_SIDED|95.0|-11.21|1.14|||Repeated measures analysis||Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in number (%) of awakenings at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||1.14|-11.21|0.1099
71008876|NCT02194699|141525398|SUPERIORITY||LS Mean difference|0.46||||0.8112|TWO_SIDED|95.0|-3.33|4.25|||Repeated measures analysis||Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in number (%) of awakenings at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||4.25|-3.33|0.8112
71045611|NCT02697773|141599470|SUPERIORITY||Least Square Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.31|-0.45|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.45|-1.31|<.0001
71045612|NCT02697773|141599470|SUPERIORITY||Least Square Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.3|-0.44|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.44|-1.30|<.0001
71045613|NCT02697773|141599470|SUPERIORITY||Least Square Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.23||0.0085|TWO_SIDED|95.0|-1.03|-0.15|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.15|-1.03|0.0085
70850344|NCT01247272|141188454|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|113.36|||||TWO_SIDED|90.0|108.03|118.96|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||118.96|108.03|
71008877|NCT02194699|141525398|SUPERIORITY||LS Mean difference|-1.19||||0.4645|TWO_SIDED|95.0|-4.4|2.01|||Repeated measures analysis||Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of mean change from baseline in number (%) of awakenings at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||2.01|-4.40|0.4645
71008878|NCT02194699|141525399|SUPERIORITY||Odds Ratio (OR)|0.77||||0.344|TWO_SIDED|95.0|0.44|1.33|||Cochran-Mantel-Haenszel||The estimate of each odds ratio was obtained from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.|Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.||1.33|0.44|0.3440
71008879|NCT02194699|141525399|SUPERIORITY||Odds Ratio (OR)|1.05||||0.7768|TWO_SIDED|95.0|0.75|1.46|||Cochran-Mantel-Haenszel||The estimate of each odds ratio was obtained from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.|Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.||1.46|0.75|0.7768
71008880|NCT02194699|141525399|SUPERIORITY||Odds Ratio (OR)|0.91||||0.5276|TWO_SIDED|95.0|0.69|1.21|||Cochran-Mantel-Haenszel||The estimate of each odds ratio was obtained from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.|Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: FAS population; Tralo 300 mg Q2W vs placebo.||1.21|0.69|0.5276
71008881|NCT02155660|141525408|SUPERIORITY||Rate ratio|0.85||||0.0638|TWO_SIDED|95.0|0.71|1.01|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.01|0.71|0.0638
71008882|NCT02155660|141525408|SUPERIORITY||Rate ratio|1.04||||0.6575|TWO_SIDED|95.0|0.88|1.23|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.23|0.88|0.6575
71008883|NCT02155660|141525408|SUPERIORITY||Rate ratio|0.93||||0.3988|TWO_SIDED|95.0|0.78|1.1|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.10|0.78|0.3988
71008884|NCT02155660|141525409|SUPERIORITY||Rate ratio|1.04||||0.7564|TWO_SIDED|95.0|0.82|1.32|||Negative binomial|Model includes treatment group, region, background therapy, number of exacerbations in the previous year.||||1.32|0.82|0.7564
71008885|NCT02155660|141525409|SUPERIORITY||Rate ratio|1.08||||0.5573|TWO_SIDED|95.0|0.84|1.37|||Negative binomial|Model includes treatment group, region, background therapy, number of exacerbations in the previous year.||||1.37|0.84|0.5573
71008886|NCT02155660|141525409|SUPERIORITY||Rate ratio|1.02||||0.8644|TWO_SIDED|95.0|0.8|1.3|||Negative binomial|Model includes treatment group, region, background therapy, number of exacerbations in the previous year.||||1.30|0.80|0.8644
71045614|NCT02697773|141599470|SUPERIORITY||Least Square Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.22||0.0657|TWO_SIDED|95.0|-0.85|0.03|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||0.03|-0.85|0.0657
71008887|NCT02155660|141525410|SUPERIORITY||Mean Difference (Final Values)|0.015||||0.5043|TWO_SIDED|95.0|-0.029|0.059|||Mixed Models Analysis|Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.059|-0.029|0.5043
71008888|NCT02155660|141525410|SUPERIORITY||Mean Difference (Final Values)|-0.007||||0.7691|TWO_SIDED|95.0|-0.051|0.037|||Mixed Models Analysis|Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.037|-0.051|0.7691
71008889|NCT02155660|141525410|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.3767|TWO_SIDED|95.0|-0.024|0.064|||Mixed Models Analysis|Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.064|-0.024|0.3767
71008890|NCT02155660|141525411|SUPERIORITY||Mean Difference (Final Values)|-1.011||||0.3636|TWO_SIDED|95.0|-3.192|1.171|||Mixed Models Analysis|Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||1.171|-3.192|0.3636
71008891|NCT02155660|141525411|SUPERIORITY||Mean Difference (Final Values)|-1.388||||0.2106|TWO_SIDED|95.0|-3.562|0.786|||Mixed Models Analysis|Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.786|-3.562|0.2106
71008892|NCT02155660|141525411|SUPERIORITY||Mean Difference (Final Values)|-0.602||||0.5851|TWO_SIDED|95.0|-2.763|1.56|||Mixed Models Analysis|Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||1.560|-2.763|0.5851
71008893|NCT02155660|141525412|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.8525|TWO_SIDED|95.0|-0.82|0.99|||Mixed Models Analysis|Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.99|-0.82|0.8525
71008894|NCT02155660|141525412|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.987|TWO_SIDED|95.0|-0.91|0.89|||Mixed Models Analysis|Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.89|-0.91|0.9870
71008895|NCT02155660|141525412|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.8204|TWO_SIDED|95.0|-1.0|0.79|||Mixed Models Analysis|Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.79|-1.00|0.8204
71008896|NCT02155660|141525413|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.2636|TWO_SIDED|95.0|-1.102|0.301|||Mixed Models Analysis|Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.301|-1.102|0.2636
71008897|NCT02155660|141525413|SUPERIORITY||Mean Difference (Final Values)|-0.296||||0.4087|TWO_SIDED|95.0|-0.998|0.406|||Mixed Models Analysis|Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.406|-0.998|0.4087
71008898|NCT02155660|141525413|SUPERIORITY||Mean Difference (Final Values)|-0.425||||0.2336|TWO_SIDED|95.0|-1.125|0.275|||Mixed Models Analysis|Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.275|-1.125|0.2336
71008899|NCT02155660|141525414|SUPERIORITY||Mean Difference (Final Values)|-0.642||||0.0012|TWO_SIDED|95.0|-1.029|-0.254|||Mixed Models Analysis|Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.254|-1.029|0.0012
71008900|NCT02155660|141525414|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.0852|TWO_SIDED|95.0|-0.727|0.047|||Mixed Models Analysis|Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.047|-0.727|0.0852
71008901|NCT02155660|141525414|SUPERIORITY||Mean Difference (Final Values)|-0.364||||0.065|TWO_SIDED|95.0|-0.75|0.023|||Mixed Models Analysis|Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.023|-0.750|0.0650
71008902|NCT02155660|141525415|SUPERIORITY||Mean Difference (Final Values)|-0.041||||0.0415|TWO_SIDED|95.0|-0.081|-0.002|||Mixed Models Analysis|Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.002|-0.081|0.0415
71008903|NCT02155660|141525415|SUPERIORITY||Mean Difference (Final Values)|-0.055||||0.0069|TWO_SIDED|95.0|-0.094|-0.015|||Mixed Models Analysis|Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.015|-0.094|0.0069
71008904|NCT02155660|141525415|SUPERIORITY||Mean Difference (Final Values)|-0.026||||0.2008|TWO_SIDED|95.0|-0.065|0.014|||Mixed Models Analysis|Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.014|-0.065|0.2008
71045615|NCT02697773|141599470|SUPERIORITY||Least Square Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.24||0.0012|TWO_SIDED|95.0|-1.25|-0.31|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.31|-1.25|0.0012
71008905|NCT02155660|141525419|SUPERIORITY||Rate ratio|0.98||||0.8158|TWO_SIDED|95.0|0.81|1.18|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.18|0.81|0.8158
71008906|NCT02155660|141525419|SUPERIORITY||Rate ratio|0.98||||0.8378|TWO_SIDED|95.0|0.82|1.18|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.18|0.82|0.8378
71045616|NCT02697773|141599470|SUPERIORITY||Least Square Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.24||0.0004|TWO_SIDED|95.0|-1.33|-0.38|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.38|-1.33|0.0004
71102641|NCT00980798|141713918|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2365||||0.1212|TWO_SIDED|95.0|-0.5357|0.0627||No adjustment for multiple comparisons necessary, as only 1 primary hypothesis was tested. Threshold for statistical significance was 0.05.|Mixed-model regression analysis|The difference above is presented as the difference OROS hydromorphone HCl minus placebo, so negative scores favour OROS hydromorphone HCl.|The analysis was adjusted for baseline BPI item 5 score, time on study, and whether the primary affected joint was the hip or knee.|The F test for treatment tested the null hypothesis of no treatment difference. Assuming that 3 baseline measures and 7 post baseline measures were collected 81 patients were required per group to detect a difference of 1 point in the BPI measure with 90% power at a significance level of 5%. To allow for a drop-out rate of approximately 40%, the study planned to recruit 135 patients per group (i.e. 270 in total).||0.0627|-0.5357|0.1212
71008907|NCT02155660|141525419|SUPERIORITY||Rate ratio|0.92||||0.3759|TWO_SIDED|95.0|0.76|1.11|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.11|0.76|0.3759
71008908|NCT02155660|141525420|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9141|TWO_SIDED|95.0|0.76|1.36|||Cochran-Mantel-Haenszel|CMH test controlling for EOS cohort, region, and background therapy.||Proportion of participants with \>=1 COPD exacerbation.||1.36|0.76|0.9141
71008909|NCT02155660|141525420|SUPERIORITY||Odds Ratio (OR)|1.39||||0.0323|TWO_SIDED|95.0|1.03|1.87|||Cochran-Mantel-Haenszel|CMH test controlling for EOS cohort, region, and background therapy.||Proportion of participants with \>=1 COPD exacerbation.||1.87|1.03|0.0323
71008910|NCT02155660|141525420|SUPERIORITY||Odds Ratio (OR)|1.1||||0.5109|TWO_SIDED|95.0|0.82|1.48|||Cochran-Mantel-Haenszel|CMH test controlling for EOS cohort, region, and background therapy.||Proportion of participants with \>=1 COPD exacerbation.||1.48|0.82|0.5109
71008911|NCT02155660|141525422|SUPERIORITY||Rate ratio|0.68||||0.0287|TWO_SIDED|95.0|0.49|0.96|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).||||0.96|0.49|0.0287
71008912|NCT02155660|141525422|SUPERIORITY||Rate ratio|0.89||||0.4631|TWO_SIDED|95.0|0.65|1.22|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).||||1.22|0.65|0.4631
71008913|NCT02155660|141525422|SUPERIORITY||Rate ratio|0.67||||0.0185|TWO_SIDED|95.0|0.48|0.94|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).||||0.94|0.48|0.0185
71008914|NCT01192139|141525427|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of saxagliptin|Ratio of Geometric Least Squares Means|1.039|||||TWO_SIDED|90.0|1.011|1.068|||||Ratio=Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of a saxagliptin tablet and a metformin XR tablet under fed conditions, then 24 subjects would have provided 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 94% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||1.068|1.011|
71008915|NCT01192139|141525427|NON_INFERIORITY_OR_EQUIVALENCE|Lack of food effect was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within (80%, 125%) for both Cmax and AUC(INF) of saxagliptin and metformin.|Ratio of Least Squares Means|1.078|||||TWO_SIDED|90.0|1.049|1.108|||||Ratio=Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|||1.108|1.049|
71008916|NCT01192139|141525427|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|104.65||||||95.0||||||||Geometric least squares means for treatment A||||
71008917|NCT01192139|141525427|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|108.74||||||95.0||||||||Geometric least squares means for treatment B||||
71008918|NCT01192139|141525427|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|100.84||||||95.0||||||||Geometric least squares mean for treatment C||||
71008919|NCT01192139|141525429|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Mean|1.039|||||TWO_SIDED|90.0|1.011|1.068|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|||1.068|1.011|
71008920|NCT01192139|141525429|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|1.08|||||TWO_SIDED|90.0|1.051|1.11|||||Ratio=Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|||1.110|1.051|
71008921|NCT01192139|141525429|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|102.84||||||95.0||||||||Geometric least squares mean for treatment A||||
71045617|NCT02697773|141599472|SUPERIORITY||Least Mean Square Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.21||0.0004|TWO_SIDED|95.0|-1.17|-0.34|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.34|-1.17|0.0004
71045618|NCT02697773|141599472|SUPERIORITY||Least Square Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.33|-0.5|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.50|-1.33|<.0001
71008922|NCT01192139|141525429|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|106.89||||||95.0||||||||Geometric least squares mean for treatment B||||
71008923|NCT01192139|141525429|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|98.99||||||95.0||||||||Geometric least squares mean for treatment C||||
71008924|NCT01192139|141525430|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of saxagliptin.|Ratio of Geometric Least Squares Means|1.021|||||TWO_SIDED|90.0|0.94|1.109|||||Ratio=Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of a saxagliptin tablet and a metformin XR tablet under fed conditions, then 24 subjects would have provided 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 94% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||1.109|0.940|
71008925|NCT01192139|141525430|NON_INFERIORITY_OR_EQUIVALENCE|Lack of food effect was concluded if the fed to fasted ratios of geometric means were entirely contained within (80%, 125%) for both Cmax and AUC(INF) of saxagliptin.|Ratio of Geometric Least Squares Means|0.949|||||TWO_SIDED|90.0|0.873|1.031|||||Ratio = Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|||1.031|0.873|
71008926|NCT01192139|141525430|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|25.68||||||95.0||||||||Geometric least squares mean for treatment A||||
71008927|NCT01192139|141525430|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|26.21||||||95.0||||||||Geometric least squares mean for treatment B||||
71008928|NCT01192139|141525430|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|27.63||||||95.0||||||||Geometric least squares mean for treatment C||||
71008929|NCT01192139|141525439|NON_INFERIORITY_OR_EQUIVALENCE|BE concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within (80%, 125%) for both Cmax and AUC(INF) of saxagliptin and metformin.|Ratio of Least Squares Geometric Means|0.915|||||TWO_SIDED|90.0|0.836|1.002|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of a saxagliptin tablet and a metformin XR tablet under fed conditions, then 24 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 96% and 97% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||1.002|0.836|
71008930|NCT01192139|141525439|NON_INFERIORITY_OR_EQUIVALENCE|lack of food effect concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within (80%, 125%) for both Cmax and AUC(INF) of saxagliptin and metformin.|Ratio of Geometric LS Mean and 90% CI|1.01|||||TWO_SIDED|90.0|0.918|1.111|||||Ratio = Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|||1.111|0.918|
71077842|NCT02913105|141664395|SUPERIORITY|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|0.93||||0.5168|TWO_SIDED|90.0|0.78|1.12|||ANCOVA|||||1.12|0.78|0.5168
70925907|NCT03637660|141345678|NON_INFERIORITY|The alternative hypothesis was that the difference in response rates was less than 10%. The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.|Difference of proportion of participants|-0.06||||0.011|TWO_SIDED|90.0|-0.18|0.05||P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) in HIV-infected participants by Farrington-Manning method with a 10% margin.|Farrington-Manning||The 2-sided 90% CI are calculated based on the noninferiority analysis for the -sproportion difference (one-dose group is non-inferior to three-dose group) among HIV-infected participants by Farrington-Manning method with a 10% margin.|The number and proportion of participants with a serological response by month 12 among participants with HIV infection and the 95% confidence interval (CI) were summarized overall and by treatment status. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis was that the difference in serological response rate between the three-dose and one-dose groups was at least 10%.||0.05|-0.18|0.011
71008931|NCT01192139|141525439|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|5542.2||||||95.0||||||||Geometric least squares means for treatment A||||
71008932|NCT01192139|141525439|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|5072.9||||||95.0||||||||Geometric least squares mean for treatment B||||
71008933|NCT01192139|141525439|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|5023.3||||||95.0||||||||Geometric least squares mean for treatment C||||
71008934|NCT01192139|141525440|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Mean|0.92|||||TWO_SIDED|90.0|0.854|0.992|||||Ratio=Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|||0.992|0.854|
71008935|NCT01192139|141525440|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|1.025|||||TWO_SIDED|95.0|0.951|1.105|||||Ratio=Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|||1.105|0.951|
71008936|NCT01192139|141525440|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|5287.1||||||95.0||||||||Geometric least squares means for treatment A||||
71008937|NCT01192139|141525440|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|4866.2||||||95.0||||||||Geometric least squares mean for treatment B||||
71008938|NCT01192139|141525440|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|4746.8||||||95.0||||||||Geometric least squares means for treatment C||||
71008939|NCT01192139|141525441|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of metformin.|Ratio of Geometric Least Squares Means|0.933|||||TWO_SIDED|95.0|0.865|1.007|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of a metformin XR tablet under fed conditions, then 24 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 96% and 97% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||1.007|0.865|
71102642|NCT04724837|141713920|SUPERIORITY|Two-sided p-value is presented. A p-value \<0.10 indicates statistical significance, which is consistent with a one-sided test at the 5% level.|Adjusted % mean change from baseline|-33.7|||<|0.001|TWO_SIDED|90.0|-42.5|-23.5|||Mixed Models Analysis||If adjusted percentage mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for UACR.|Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + Placebo (PBO)||-23.5|-42.5|<0.001
71008940|NCT01192139|141525441|NON_INFERIORITY_OR_EQUIVALENCE|Lack of food effect was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within (80%, 125%) for both Cmax and AUC(inf) of saxagliptin and metformin.|Ratio of Geometric Least Squares Means|0.898|||||TWO_SIDED|90.0|0.832|0.969|||||Ration = Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|||0.969|0.832|
71008941|NCT01192139|141525441|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|608.41||||||95.0||||||||Geometric least squares mean for treatment A||||
71008942|NCT01192139|141525441|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|567.85||||||95.0||||||||Geometric least squares mean for treatment B||||
71008943|NCT01192139|141525441|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|632.39||||||95.0||||||||Geometric least squares mean for treatment C||||
71008944|NCT04853368|141525455|SUPERIORITY||LS Mean of Difference|2.6|STANDARD_ERROR_OF_MEAN|0.84||0.002|TWO_SIDED|90.0|1.22|4.04||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|Primary analysis of ppFEV1 using MMRM excludes data inconsistent with baseline in terms of the timing of bronchodilator or airway clearance regimen.||||4.04|1.22|0.002
71008945|NCT04853368|141525455|SUPERIORITY||LS Mean of Difference|1.3|STANDARD_ERROR_OF_MEAN|1.92||0.254|TWO_SIDED|90.0|-2.07|4.67||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|Primary analysis of ppFEV1 using MMRM excludes data inconsistent with baseline in terms of the timing of bronchodilator or airway clearance regimen.||||4.67|-2.07|0.254
71008946|NCT04853368|141525455|SUPERIORITY||LS Mean of Difference|0.9||||0.402|TWO_SIDED|90.0|-5.07|6.77||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|Primary analysis of ppFEV1 using MMRM excludes data inconsistent with baseline in terms of the timing of bronchodilator or airway clearance regimen.||||6.77|-5.07|0.402
71008947|NCT04853368|141525457|SUPERIORITY||LS Mean of Difference|5.5|STANDARD_ERROR_OF_MEAN|2.63||0.022|TWO_SIDED|90.0|1.07|9.92||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||9.92|1.07|0.022
71008948|NCT04853368|141525457|SUPERIORITY||LS Mean of Difference|-14.1||||0.043|TWO_SIDED|90.0|-27.59|-0.62||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||-0.62|-27.59|0.043
71008949|NCT04853368|141525458|SUPERIORITY||LS Mean of Difference|0.14|STANDARD_ERROR_OF_MEAN|0.047||0.003|TWO_SIDED|90.0|0.059|0.219||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||0.219|0.059|0.003
71008950|NCT04853368|141525458|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.089||0.475|TWO_SIDED|90.0|-0.162|0.15||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||0.150|-0.162|0.475
71008951|NCT04853368|141525458|SUPERIORITY||LS Mean of Difference|-0.06||||0.352|TWO_SIDED|90.0|-0.332|0.212||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||Cohort 2: Difference between Triple Therapy and Placebo||0.212|-0.332|0.352
71008952|NCT04853368|141525459|SUPERIORITY||LS Mean of Difference|0.089|STANDARD_ERROR_OF_MEAN|0.0403||0.017|TWO_SIDED|90.0|0.0209|0.1568||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||0.1568|0.0209|0.017
71008953|NCT04853368|141525459|SUPERIORITY||LS Mean of Difference|0.103|STANDARD_ERROR_OF_MEAN|0.1033||0.169|TWO_SIDED|90.0|-0.1814|0.288||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||0.2880|-0.1814|0.169
71008954|NCT04853368|141525459|SUPERIORITY||Mean Difference (Final Values)|0.136||||0.23|TWO_SIDED|90.0|-0.1809|0.4527||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||0.4527|-0.1809|0.230
71008955|NCT04853368|141525460|SUPERIORITY||LS Mean of Difference|4.4||||0.002|TWO_SIDED|90.0|2.04|6.78||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||6.78|2.04|0.002
71045619|NCT02697773|141599472|SUPERIORITY||Least Square Mean Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.45|-0.6|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.60|-1.45|<.0001
71045620|NCT02697773|141599472|SUPERIORITY||Least Square Mean Difference|-1.11|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.53|-0.68|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.68|-1.53|<.0001
71008956|NCT04853368|141525460|SUPERIORITY||LS Mean of Difference|1.3||||0.35|TWO_SIDED|90.0|-4.42|6.97||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||6.97|-4.42|0.350
71008957|NCT04853368|141525460|SUPERIORITY||LS Mean of Difference|1.3||||0.412|TWO_SIDED|90.0|-8.75|11.34||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||11.34|-8.75|0.412
71008958|NCT04853368|141525461|SUPERIORITY||LS Mean of Difference|4.36|||<|0.001|TWO_SIDED|90.0|2.19|6.524||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||6.524|2.190|<0.001
71008959|NCT04853368|141525461|SUPERIORITY||LS Mean of Difference|-0.59||||0.396|TWO_SIDED|90.0|-4.449|3.268||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||3.268|-4.449|0.396
71008960|NCT04853368|141525461|SUPERIORITY||LS Mean of Difference|-2.0||||0.305|TWO_SIDED|90.0|-8.724|4.732||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||4.732|-8.724|0.305
71008961|NCT04853368|141525462|SUPERIORITY||LS Mean of Difference|6.475||||0.018|TWO_SIDED|90.0|1.4443|11.5056||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||11.5056|1.4443|0.018
71045621|NCT02697773|141599472|SUPERIORITY||Least Square Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.23||0.0057|TWO_SIDED|95.0|-1.07|-0.18|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.18|-1.07|0.0057
71008962|NCT04853368|141525462|SUPERIORITY||LS Mean of Difference|6.019||||0.214|TWO_SIDED|90.0|-7.1464|19.1844||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||19.1844|-7.1464|0.214
71008963|NCT04853368|141525462|SUPERIORITY||LS Mean of Difference|7.29||||0.286|TWO_SIDED|90.0|-15.186|29.766||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||29.7660|-15.1860|0.286
71008964|NCT04853368|141525463|SUPERIORITY||LS Mean of Difference|5.6||||0.057|TWO_SIDED|90.0|-0.26|11.37||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||11.37|-0.26|0.057
71008965|NCT04853368|141525463|SUPERIORITY||LS Mean of Difference|8.6||||0.088|TWO_SIDED|90.0|-2.18|19.4||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||19.40|-2.18|0.088
71008966|NCT04853368|141525463|SUPERIORITY||LS Mean of Difference|11.2||||0.142|TWO_SIDED|90.0|-6.9|29.25||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|Note: The LS mean is estimated using the linear regression on the change in CFQ-R from baseline to day 29.||||29.25|-6.90|0.142
71045622|NCT02697773|141599472|SUPERIORITY||Least Square Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.23||0.0114|TWO_SIDED|95.0|-1.02|-0.13|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.13|-1.02|0.0114
71102643|NCT04724837|141713921|SUPERIORITY|Two-sided p-value is presented. A p-value \<0.10 indicates statistical significance, which is consistent with a one-sided test at the 5% level.|Adjusted % mean change from baseline|-27.0||||0.002|TWO_SIDED|90.0|-38.4|-13.6|||Mixed Models Analysis||If adjusted percentage mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for UACR.|Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-13.6|-38.4|0.002
71102644|NCT04724837|141713922|SUPERIORITY||Least Square (LS) mean CFB|-3.6|||||TWO_SIDED|90.0|-6.8|-0.5|||Mixed Models Analysis||If mean change from baseline (CFB) \>0 then the result favours Dapa 10 mg + PBO for office systolic blood pressure.|Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-0.5|-6.8|
71102645|NCT04724837|141713922|SUPERIORITY||LS mean CFB|-7.6|||||TWO_SIDED|90.0|-10.3|-4.9|||Mixed Models Analysis||If mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for office systolic blood pressure.|Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-4.9|-10.3|
70941319|NCT00577096|141383061|NON_INFERIORITY_OR_EQUIVALENCE|T-test and chi-squared to check for equivalence of groups for age, race and gender.|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis was that there would be no difference between groups for the number of days of stem cell collections.||||<0.025
71008967|NCT04495166|141525497|SUPERIORITY|||||||0.757||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||The sample size was calculated based on an effect size of 0.65 on depression, which is based on a previous meta-analysis (Sockol et al., 2011). Sample size calculation considered a difference in means between two independent groups, probability of type I error of 5%, statistical power of 80%, a two-tailed test, and a dropout rate of 15%.||||0.757
71008968|NCT04495166|141525498|SUPERIORITY|||||||0.91||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||||||0.910
71008969|NCT04495166|141525500|SUPERIORITY|||||||0.442||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||||||0.442
71008970|NCT04495166|141525501|SUPERIORITY|||||||0.223||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||||||0.223
71008971|NCT04495166|141525502|SUPERIORITY|||||||0.54||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||||||0.540
71008972|NCT04495166|141525503|SUPERIORITY|||||||0.901||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||||||0.901
71008973|NCT04495166|141525504|SUPERIORITY|||||||0.748||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||||||0.748
71008974|NCT02643420|141525520|NON_INFERIORITY|The margin of non-inferiority to be used in the study is 0.62 day. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% confidence interval (CI) of the difference in mean DSN between the treatment arms was \<0.62 days.|Mean Difference (Final Values)|-0.148|||<|0.0001|TWO_SIDED|95.0|-0.266|-0.031|||t-statistics|The p-values are based on the calculated t-statistics from the bootstrapped sample mean and standard deviation.||||-0.031|-0.266|<0.0001
71008975|NCT02643420|141525521|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.685|TWO_SIDED|95.0|-1.43|0.94|||Negative binomial regression|||||0.94|-1.43|0.685
71008976|NCT02643420|141525522|SUPERIORITY||Median Difference (Final Values)|1.2||||0.155|TWO_SIDED|95.0|0.93|1.56|||Asymptotic normality assumption|P-value was obtained based upon asymptotic normality assumption on the log10 transformed data.||||1.56|0.93|0.155
71008977|NCT02643420|141525523|SUPERIORITY||Percent Difference|1.1||||0.435|TWO_SIDED|95.0|-8.6|10.8|||Fisher Exact|||||10.8|-8.6|0.435
71008978|NCT02643420|141525524|NON_INFERIORITY|The margin of non-inferiority to be used in the study is 0.62 day. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% CI of the difference in mean DSN between the treatment arms was \<0.62 days.|Mean Difference (Final Values)|0.042|||<|0.0001|TWO_SIDED|95.0|-0.032|0.116|||t-statistics|||DSN in Cycle 2||0.116|-0.032|<0.0001
71008979|NCT02643420|141525524|NON_INFERIORITY|The margin of non-inferiority to be used in the study is 0.62 day. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% CI of the difference in mean DSN between the treatment arms was \<0.62 days.|Mean Difference (Final Values)|0.026|||<|0.0001|TWO_SIDED|95.0|-0.032|0.085|||t-statistics|||DSN in Cycle 3||0.085|-0.032|<0.0001
71102646|NCT04724837|141713923|SUPERIORITY||LS Mean CFB|-3.0|||||TWO_SIDED|90.0|-5.0|-1.0|||Mixed Models Analysis||If mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for office diastolic blood pressure.|Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-1.0|-5.0|
71008980|NCT02643420|141525524|NON_INFERIORITY|The margin of non-inferiority to be used in the study is 0.62 day. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% CI of the difference in mean DSN between the treatment arms was \<0.62 days.|Mean Difference (Final Values)|0.027|||<|0.0001|TWO_SIDED|95.0|-0.036|0.089|||t-statistics|||DSN in Cycle 4||0.089|-0.036|<0.0001
71008981|NCT02643420|141525525|SUPERIORITY||Percent Difference|0.3||||1|TWO_SIDED|95.0|-9.5|10.0|||Fisher Exact|||||10.0|-9.5|1.000
71008982|NCT02643420|141525526|SUPERIORITY||Percent Difference|0.0||||1|TWO_SIDED|95.0|-9.7|9.8|||Fisher Exact|||FN in Cycle 2||9.8|-9.7|1.000
71008983|NCT02643420|141525526|SUPERIORITY||Percent Difference|1.6||||0.201|TWO_SIDED|95.0|-8.2|11.3|||Fisher Exact|||FN in Cycle 3||11.3|-8.2|0.201
71008984|NCT02643420|141525526|SUPERIORITY||Percent Difference|1.0||||0.232|TWO_SIDED|95.0|-8.7|10.8|||Fisher Exact|||FN in Cycle 4||10.8|-8.7|0.232
71008985|NCT02127970|141525529|NON_INFERIORITY|The non-inferiority hypothesis test was to be a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the 95% CI for the difference in responder rates is greater than -10%, then the single-dose dalbavancin regimen was to be declared non-inferior to the two dose dalbavancin regimen.|Difference|-2.9|||||TWO_SIDED|95.0|-8.5|2.8|||||For the difference in clinical responder rates (single-dose group minus two dose group), the 95% CI was calculated using the Miettinen and Nurminen method without adjustment.|||2.8|-8.5|
71008986|NCT00542321|141525559|SUPERIORITY_OR_OTHER||difference between proportions|0.5||||1|TWO_SIDED|95.0|||||Fisher Exact|Chi-Square = 0.750, df = 1||Pearson Chi-Square Test for difference between groups||||1.00
71008987|NCT00542321|141525560|SUPERIORITY_OR_OTHER||Rank sums|52.0||||1|TWO_SIDED|95.0||||Alpha = .05|Wilcoxon (Mann-Whitney)|||There will be no difference in duration of mechanical ventilation between groups.||||1.0
71008988|NCT00542321|141525561|SUPERIORITY_OR_OTHER|||||||0.451||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.451
71008989|NCT00542321|141525562|SUPERIORITY_OR_OTHER||probability|0.43||||1||95.0|||||Fisher Exact|||||||1.0
71008990|NCT00542321|141525563|SUPERIORITY_OR_OTHER||Rank sums|56.0||||1|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||1.0
71008991|NCT04138758|141525568|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.68|0.85|||||Hazard Ratio lower than 1 favors Tiotropium + Olodaterol.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid therapy combination on the risk of a first COPD exacerbation.||0.85|0.68|
71008992|NCT04138758|141525569|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.57|0.97|||||Hazard Ratio lower than 1 favors Tiotropium + Olodaterol.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid therapy combination on the risk of first hospitalization for community-acquired pneumonia.||0.97|0.57|
71008993|NCT04138758|141525570|OTHER|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid therapy combination on the risk of escalation.|Hazard Ratio (HR)|0.23|||||TWO_SIDED|95.0|0.19|0.27|||||Hazard Ratio lower than 1 favors Tiotropium + Olodaterol.|||0.27|0.19|
71008994|NCT04138758|141525571|OTHER||Hazard Ratio (HR)|0.22|||||TWO_SIDED|95.0|0.19|0.26|||||Hazard Ratio lower than 1 favors Tiotropium + Olodaterol.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid therapy combination on the risk of escalation.||0.26|0.19|
71008995|NCT04138758|141525572|OTHER||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.42|0.51|||||Hazard Ratio lower than 1 favors Tiotropium + Olodaterol.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid therapy combination on the risk of any element of a composite outcome including exacerbation, hospitalization for pneumonia, or escalation.||0.51|0.42|
71008996|NCT04138758|141525573|OTHER||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.41|0.49|||||Hazard Ratio lower than 1 favors Tiotropium + Olodaterol.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid therapy combination on the risk of any element of a composite outcome including exacerbation, hospitalization for pneumonia, or escalation.||0.49|0.41|
71008997|NCT00125138|141525638|SUPERIORITY_OR_OTHER||Difference of LS Mean|0.1||||0.5177|TWO_SIDED|95.0|-6.3|6.6||One-sided pairwise p-value comparing each active treatment to placebo.|ANCOVA|One-way ANCOVA: Treatment, country, and baseline anti-psychotic medication status (recent or distant) as factors; baseline measurement as a covariate||The null hypothesis for each endpoint is that each melperone dose has the same mean as placebo; the alternative hypothesis is that at least one dose is more efficacious than placebo. Only subjects with both a baseline and Day 43 (end of Maintenance Phase) value are included.||6.6|-6.3|0.5177
71008998|NCT00125138|141525638|SUPERIORITY_OR_OTHER||Difference of LS mean|-2.9||||0.1519|TWO_SIDED|95.0|-8.5|2.7||One-sided pairwise p-value comparing each active treatment to placebo.|ANCOVA|One-way ANCOVA: Treatment, country, and baseline anti-psychotic medication status (recent or distant) as factors; baseline measurement as a covariate.||The null hypothesis for each endpoint is that each melperone dose has the same mean as placebo; the alternative hypothesis hypothesis is that at least one dose is more efficacious than placebo. Only subjects with both a baseline and Day 43 (end of Maintenance Phase) value are included.||2.7|-8.5|0.1519
71008999|NCT00125138|141525638|SUPERIORITY_OR_OTHER||Difference of LS mean|0.3||||0.5406|TWO_SIDED|95.0|-5.2|5.8||One-sided pairwise p-value comparing each active treatment to placebo.|ANCOVA|One-way ANCOVA: Treatment, country, and baseline anti-psychotic medication status (recent or distant) as factors; baseline measurement as a covariate.||The null hypothesis for each endpoint is that each melperone dose has the same mean as placebo; the alternative hypothesis is that at least one dose is more efficacious than placebo. Only subjects with both a baseline and Day 43 (end of Maintenance Phase) value are included.||5.8|-5.2|0.5406
71009000|NCT00125138|141525639|SUPERIORITY_OR_OTHER|||||||0.9212||95.0||||Overall p-value using a one-way ANCOVA.|ANCOVA|One-way ANCOVA: Treatment, country, and baseline anti-psychotic medication status (recent or distant) as factors; baseline measurement as a covariate.||Only subjects with both a baseline and a post-baseline value are included.||||0.9212
71009001|NCT00041119|141525640|SUPERIORITY|If the 5-year DFS for 4 cycles is 84.7% then a decrease of 23% in hazard rate for 6 cycles corresponds to an increase in 5-year DFS to 88%. Assuming a 2-sided significance level of 0.05, there is 90.9% power to detect such an increase at the final analysis conducted 6.4 years after study activation.|Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.84|1.28||||||The null hypothesis is that the hazards of both 6 and 4 cycle regimens are equal. The alternative hypothesis is a hazard ratio of 0.77, corresponding to a decrease of 23% in hazard due to longer duration of chemotherapy.||1.28|0.84|
71009002|NCT00041119|141525641|EQUIVALENCE|For T to be considered equivalent to the standard CA, a confidence interval of the hazard ratio of T to CA should be wholly to the left of 1.3, corresponding to a 30% increase in hazard rate. If the 5-year DFS for CA is 88% then an increase of 30% in hazard rate for T corresponds to 5-year DFS of 84.7%. The null hypothesis is that the hazard ratio of T to CA exceeds 1.3. The alternative hypothesis is that the two hazard rates are equivalent.|Hazard Ratio (HR)|1.26|||||ONE_SIDED|95.0||1.48||||||||1.48||
71009003|NCT00041119|141525642|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were designed to detect effects in the marginal distributions of the two study factors, agent and length, and assume no interaction between the two factors. Calculations also assume exponential DFS and a total of 4556 treated patients accrued over 29 months and followed for four years after accrual termination for a total study time of 6.4 years. We assume the 5-year DFS of CA therapy is 88% and 84.7% for T. These assumptions are based upon results of SWOG 8897.|Hazard Ratio (HR)|1.27|||||ONE_SIDED|95.0||1.56||||||||1.56||
71009004|NCT00041119|141525646|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were designed to detect effects in the marginal distributions of the two study factors, agent and length, and assume no interaction between the two factors. Calculations also assume exponential DFS and a total of 4556 treated patients accrued over 29 months and followed for four years after accrual termination for a total study time of 6.4 years.|Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.84|1.49||||||||1.49|.84|
71009005|NCT00783263|141525681|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.25|||<|0.001|TWO_SIDED|95.0|-19.89|-10.6|||Longitudinal Data Analysis (LDA)|Longitudinal Data Analysis was based on a constrained LDA model with terms for treatment, time, stratum and the interaction of time by treatment.||||-10.60|-19.89|<0.001
71009006|NCT00783263|141525682|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.31|||<|0.001|TWO_SIDED|95.0|-18.95|-5.67|||Longitudinal Data Analysis (LDA)|Longitudinal Data Analysis was based on a constrained LDA model with terms for treatment, time and the interaction of time by treatment.||||-5.67|-18.95|<0.001
71009007|NCT00783263|141525682|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.46|||<|0.001|TWO_SIDED|95.0|-23.92|-10.99|||Longitudinal Data Analysis (LDA)|Longitudinal Data Analysis was based on a constrained LDA model with terms for treatment, time and the interaction of time by treatment.||||-10.99|-23.92|<0.001
71009008|NCT00783263|141525683|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.5|||<|0.001|TWO_SIDED|95.0|2.9|6.9|||Logistic Regression|Logistic Regression included terms for treatment, stratum and baseline LDL-C category (3 levels: \<100, 100-\<130, ≥130 mg/dL).||||6.9|2.9|<0.001
71009009|NCT00783263|141525684|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.1|||<|0.001|TWO_SIDED|95.0|1.7|5.8|||Logistic Regression|Logistic Regression included terms for treatment and baseline LDL-C category (3 levels: \<100, 100-\<130, \>=130 mg/dL).||||5.8|1.7|<0.001
71009010|NCT00783263|141525684|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.5|||<|0.001|TWO_SIDED|95.0|3.4|12.3|||Logistic Regression|Logistic Regression included terms for treatment and baseline LDL-C category (3 levels: \<100, 100-\<130, \>=130 mg/dL).||||12.3|3.4|<0.001
71009011|NCT00783263|141525685|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.0|||<|0.001|TWO_SIDED|95.0|4.6|14.0|||Logistic Regression|||||14.0|4.6|<0.001
70850345|NCT01247272|141188455|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|107.78|||||TWO_SIDED|90.0|102.18|113.69|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||113.69|102.18|
71009012|NCT00783263|141525686|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.1|||<|0.001|TWO_SIDED|95.0|2.2|11.8|||Logistic Regression|||Stratum I||11.8|2.2|<0.001
71009013|NCT00783263|141525686|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|11.4|||<|0.001|TWO_SIDED|95.0|5.2|24.8|||Logistic Regression|||Stratum II||24.8|5.2|<0.001
71009014|NCT00783263|141525687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.65|||<|0.001|TWO_SIDED|95.0|-11.59|-5.71|||Longitudinal Data Analysis|||Total Cholesterol (mg/dL)||-5.71|-11.59|<0.001
71009015|NCT00783263|141525687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1||||0.306|TWO_SIDED|95.0|-9.04|2.84|||Longitudinal Data Analysis|||Triglycerides (mg/dL)||2.84|-9.04|0.306
71009016|NCT00783263|141525687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.15||||0.111|TWO_SIDED|95.0|-4.79|0.49|||Longitudinal Data Analysis|||High-Density Lipoprotein Cholesterol||0.49|-4.79|0.111
71009017|NCT00783263|141525687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.98|||<|0.001|TWO_SIDED|95.0|-16.1|-7.86|||Longitudinal Data Analysis|||Non High-Density Liproprotein Cholesterol||-7.86|-16.10|<0.001
71009018|NCT00783263|141525687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.25|||<|0.001|TWO_SIDED|95.0|-18.36|-8.13|||Longitudinal Data Analysis|||LDL Cholesterol/HDL Cholesterol||-8.13|-18.36|<0.001
71009019|NCT00783263|141525687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.45||||0.002|TWO_SIDED|95.0|-10.53|-2.36|||Longitudinal Data Analysis|||Total Cholesterol/HDL Cholesterol||-2.36|-10.53|0.002
71009020|NCT00783263|141525687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.52||||0.001|TWO_SIDED|95.0|-15.3|-3.75|||Longitudinal Data Analysis|||Non-HDL Cholestrol/HDL Cholesterol||-3.75|-15.30|0.001
71009021|NCT00783263|141525687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.41|||<|0.001|TWO_SIDED|95.0|-12.74|-6.08|||Longitudinal Data Analysis|||Apolipoprotein B (Apo B)||-6.08|-12.74|<0.001
71009022|NCT00783263|141525687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.82||||0.102|TWO_SIDED|95.0|-3.99|0.36|||Longitudinal Data Analysis|||Apolipoprotein A-I (Apo A-I)||0.36|-3.99|0.102
71009023|NCT00783263|141525687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.54|||<|0.001|TWO_SIDED|95.0|-11.25|-3.83|||Longitudinal Data Analysis|||Apolipoprotein B/Apo A-I||-3.83|-11.25|<0.001
71009024|NCT00783263|141525687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.08||||0.861|TWO_SIDED|95.0|-13.13|10.97|||Longitudinal Data Analysis|||hs-C-Reactive Protein||10.97|-13.13|0.861
71009025|NCT00405756|141525688|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.395|||<|0.001|TWO_SIDED|95.0|0.278|0.56||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank|||||0.560|0.278|<0.001
71009026|NCT00405756|141525688|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.494|||<|0.001|TWO_SIDED|95.0|0.347|0.702||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank|||||0.702|0.347|<0.001
71009027|NCT00405756|141525688|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.796||||0.134|TWO_SIDED|95.0|0.589|1.075||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank|||||1.075|0.589|0.134
71009028|NCT00405756|141525689|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.34|||<|0.001|TWO_SIDED|95.0|0.214|0.541|||Log Rank|P-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.||||0.541|0.214|<0.001
71009029|NCT00405756|141525691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.337|||<|0.001|TWO_SIDED|95.0|0.231|0.493||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank|||||0.493|0.231|<0.001
71009030|NCT00405756|141525691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.414|||<|0.001|TWO_SIDED|95.0|0.284|0.603||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank|||||0.603|0.284|<0.001
71009031|NCT00405756|141525691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.826||||0.223|TWO_SIDED|95.0|0.606|1.125||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank|||||1.125|0.606|0.223
71009032|NCT00405756|141525692|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value calculation excludes the category - Response not evaluable (NE)|Wilcoxon (Mann-Whitney)|||||||<0.001
71009033|NCT00405756|141525692|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value calculation excludes the category - Response not evaluable (NE)|Wilcoxon (Mann-Whitney)|||||||0.009
71009034|NCT00405756|141525692|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value calculation excludes the category - Response not evaluable (NE)|Wilcoxon (Mann-Whitney)|||||||0.003
71009035|NCT00405756|141525692|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.34|||<|0.001|TWO_SIDED|95.0|2.04|5.47|||Fisher Exact|||Based on dichotomized response: 1) CR or PR 2) SD or PD or NE||5.47|2.04|<0.001
71009036|NCT00405756|141525692|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.096|TWO_SIDED|95.0|0.95|2.62|||Fisher Exact|||Based on dichotomized response: 1) CR or PR 2) SD or PD or NE||2.62|0.95|0.096
71009037|NCT00405756|141525692|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.12||||0.002|TWO_SIDED|95.0|1.33|3.37|||Fisher Exact|||Based on dichotomized response: 1) CR or PR 2) SD or PD or NE||3.37|1.33|0.002
71045623|NCT02697773|141599472|SUPERIORITY||Least Square Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.24||0.0004|TWO_SIDED|95.0|-1.33|-0.38|||ANCOVA|||Week 12:Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.38|-1.33|0.0004
71045624|NCT02697773|141599472|SUPERIORITY||Least Square Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.52|-0.58|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.58|-1.52|<.0001
71045625|NCT02697773|141599474|SUPERIORITY||Least Mean Square Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.0236|TWO_SIDED|95.0|-0.32|-0.02|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||-0.02|-0.32|0.0236
71009038|NCT00405756|141525694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.348|||<|0.001|TWO_SIDED|95.0|0.228|0.531||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank|||||0.531|0.228|<0.001
71009039|NCT00405756|141525694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.419|||<|0.001|TWO_SIDED|95.0|0.281|0.623||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank|||||0.623|0.281|<0.001
71009040|NCT00405756|141525694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.825||||0.302|TWO_SIDED|95.0|0.571|1.191||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank|||||1.191|0.571|0.302
71009041|NCT00405756|141525695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.404|||<|0.001|TWO_SIDED|95.0|0.296|0.553||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank|||||0.553|0.296|<0.001
71009042|NCT00405756|141525695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.499|||<|0.001|TWO_SIDED|95.0|0.363|0.688||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank|||||0.688|0.363|<0.001
71009043|NCT00405756|141525695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.827||||0.169|TWO_SIDED|95.0|0.63|1.085||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank|||||1.085|0.630|0.169
71009044|NCT00089505|141525721|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.69|||<|0.001|TWO_SIDED|95.0|1.79|7.61||P-value was not adjusted for multiple interim analyses, but any adjustment would be negligible because Peto-Haybittle spending function was used as a basis for calculating the repeated confidence intervals used in interim monitoring.|Regression, Cox|The model was stratified by screening CD4 strata (\<50 vs. \>=50 cells/mm\^3).|The HR is for NVP/NVP vs. NVP/LPV\_r.|||7.61|1.79|<0.001
71009045|NCT00089505|141525722|NON_INFERIORITY_OR_EQUIVALENCE|NoNVP/NVP regimen will be considered equivalent to the NoNVP/LPV\_r regimen if the two-sided 95% confidence interval for the hazard ratio for virologi falure is entirely below 2.0; equivalence will be established if the same confidence interval is entirely within the range 0.5 to 2.0.|Hazard Ratio (HR)|0.85||||0.43|TWO_SIDED|95.0|0.56|1.29||P-value is for a test of superiority and was not adjusted for interim analyses, but any adjustment would be negligible because Peto-Haybittle spending function was used as a basis for calculating the repeated confidence intervals used.|Regression, Cox|The cox proportional hazard model was stratified by screening CD4 strata (\<50 vs. \>=50 cells/mm3).|The HR is for NoNVP/NVP vs. NoNVP/LPV\_r.|||1.29|0.56|0.43
71009046|NCT01117428|141525730|EQUIVALENCE|Differences between Parts E and F in terms of Best Overall Response evaluated from screening until disease progression.||||||0.6645||||||No adjustment, 5% significance level|Fisher Exact|||||||0.6645
71009047|NCT02532998|141525733|SUPERIORITY_OR_OTHER||Treatment differences|-1.258|||||TWO_SIDED|90.0|-1.721|0.7945|||mixed linear model|Analyses done using mixed linear model involving fixed effect, random effect, and a covariate.||Statistical analysis of urinary sodium/potassium ratio between Treatment C and Treatment D.||0.7945|-1.721|
71077843|NCT02913105|141664395|SUPERIORITY|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|0.93||||0.374|TWO_SIDED|90.0|0.8|1.07|||ANCOVA|||||1.07|0.80|0.3740
70925908|NCT03637660|141345678|NON_INFERIORITY|The alternative hypothesis was that the difference in response rates was less than 10%. The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.|Difference of proportion of participants|-0.03||||0.064|TWO_SIDED|90.0|-0.18|0.11||P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) among HIV-uninfected participants by Farrington-Manning method with a 10% margin.|Farrington-Manning||The 2-sided 90% CI are calculated based on the noninferiority analysis for the -sproportion difference (one-dose group is non-inferior to three-dose group) among HIV-uninfected participants by Farrington-Manning method with a 10% margin.|The number and proportion of participants with a serological response by month 12 amont participants without HIV infection and the 95% confidence interval (CI) were summarized overall and by treatment status. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis was that the difference in serological response rate between the three-dose and one-dose groups was at least 10%.||0.11|-0.18|0.064
70925909|NCT05492318|141345718|OTHER|please note that GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the geometric least square mean|105.67|||||TWO_SIDED|90.0|91.72|121.74||||||"Midazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Midazolam IV.~Cmax"||121.74|91.72|
70925910|NCT05492318|141345718|OTHER|please note that GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the geometric least square mean|91.56|||||TWO_SIDED|90.0|86.16|97.31||||||1-Hydroxymidazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Midazolam IV - Cmax||97.31|86.16|
70925911|NCT05492318|141345718|OTHER|please note that GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|92.13|||||TWO_SIDED|90.0|75.97|111.73||||||Midazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Midazolam IV - Cmax||111.73|75.97|
70925912|NCT05492318|141345718|OTHER|please note that GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|93.59|||||TWO_SIDED|90.0|83.72|104.63||||||1-Hydroxymidazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Midazolam IV - Cmax||104.63|83.72|
71009048|NCT02532998|141525748|SUPERIORITY_OR_OTHER||Treatment differences|3.409|||||TWO_SIDED|90.0|2.946|3.872|||mixed linear model|Analyses done using mixed linear model involving fixed effect, random effect, and a covariate.||Statistical analysis of urinary sodium/potassium ratio between Treatment A and Treatment B.||3.872|2.946|
71009049|NCT02519777|141525760|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in normalized composite neurocognitive test scores at Week 48 from baseline||||0.60
71045626|NCT02697773|141599474|SUPERIORITY||Least Square Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.0958|TWO_SIDED|95.0|-0.27|0.02|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis subscale and baseline diary average pain as covariate, and study site as a random effect.||0.02|-0.27|0.0958
70925913|NCT05492318|141345718|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 7) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|124.02|||||TWO_SIDED|90.0|114.38|134.47||||||Midazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - Cmax||134.47|114.38|
70925914|NCT05492318|141345718|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 7) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|117.47|||||TWO_SIDED|90.0|104.78|131.69||||||1-Hydroxymidazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - Max||131.69|104.78|
71045627|NCT02697773|141599474|SUPERIORITY||Least Square Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.07||0.0007|TWO_SIDED|95.0|-0.4|-0.11|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||-0.11|-0.40|0.0007
70925915|NCT05492318|141345718|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 18) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of geometric LS means|139.28|||||TWO_SIDED|90.0|128.71|150.67||||||Midazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - Cmax||150.67|128.71|
70925916|NCT05492318|141345718|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 18) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of geometric LS means|141.61|||||TWO_SIDED|90.0|122.36|163.88||||||1-Hydroxymidazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - Cmax||163.88|122.36|
70925917|NCT05492318|141345719|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|73.68|||||TWO_SIDED|90.0|60.77|89.33||||||Total Dabigatran: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - Cmax||89.33|60.77|
71009050|NCT02519777|141525760|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 48 from baseline||||0.33
71045628|NCT02697773|141599474|SUPERIORITY||Least Mean Square Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.07||0.004|TWO_SIDED|95.0|-0.36|-0.07|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||-0.07|-0.36|0.0040
70925918|NCT05492318|141345719|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|70.38|||||TWO_SIDED|90.0|57.94|85.5||||||Free Dabigatran: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - Cmax||85.50|57.94|
70925919|NCT05492318|141345719|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|65.31|||||TWO_SIDED|90.0|53.33|79.98||||||Total Dabigatran: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - Cmax||79.98|53.33|
71102647|NCT04724837|141713923|SUPERIORITY||LS Mean CFB|-5.4|||||TWO_SIDED|90.0|-7.1|-3.7|||Mixed Models Analysis||If mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for office diastolic blood pressure.|Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-3.7|-7.1|
71102648|NCT04724837|141713924|SUPERIORITY||Adjusted % mean change from baseline|-27.0|||||TWO_SIDED|90.0|-38.4|-13.6|||Mixed Models Analysis||If adjusted percentage mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for UACR.|Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-13.6|-38.4|
71102649|NCT04724837|141713924|SUPERIORITY||Adjusted % mean change from baseline|-33.7|||||TWO_SIDED|90.0|-42.5|-23.5|||Mixed Models Analysis||If adjusted percentage mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for UACR.|Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-23.5|-42.5|
71102650|NCT04724837|141713925|SUPERIORITY||LS mean CFB|1.1|||||TWO_SIDED|90.0|-0.5|2.6|||Mixed Models Analysis||If mean change from baseline \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 1 - Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||2.6|-0.5|
71102651|NCT04724837|141713925|SUPERIORITY||LS mean CFB|-0.8|||||TWO_SIDED|90.0|-2.1|0.5|||Mixed Models Analysis||If mean change from baseline \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 1 - Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||0.5|-2.1|
71102652|NCT04724837|141713925|SUPERIORITY||LS mean CFB|-1.2|||||TWO_SIDED|90.0|-2.8|0.5|||Mixed Models Analysis||If mean change from baseline \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 12 - Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||0.5|-2.8|
71102653|NCT04724837|141713925|SUPERIORITY||LS mean CFB|-1.1|||||TWO_SIDED|90.0|-2.5|0.3|||Mixed Models Analysis||If mean change from baseline \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 12 - Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||0.3|-2.5|
71102654|NCT04724837|141713925|SUPERIORITY||LS mean CFB|0.1|||||TWO_SIDED|90.0|-1.6|1.8|||Mixed Models Analysis||If mean change from baseline \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 14 - Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||1.8|-1.6|
71102655|NCT04724837|141713925|SUPERIORITY||LS mean CFB|-2.1|||||TWO_SIDED|90.0|-3.5|-0.7|||Mixed Models Analysis||If mean change from baseline \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 14 - Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-0.7|-3.5|
71102656|NCT04724837|141713927|SUPERIORITY||LS mean change|-2.2|||||TWO_SIDED|90.0|-4.0|-0.4|||Mixed Models Analysis||If mean change \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 1 and Week 12 - Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-0.4|-4.0|
71102657|NCT04724837|141713927|SUPERIORITY||LS mean change|-0.3|||||TWO_SIDED|90.0|-1.8|1.3|||Mixed Models Analysis||If mean change \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 1 and 12 - Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||1.3|-1.8|
71102658|NCT00967499|141713957|SUPERIORITY|||||||0.401|||||||Cochran-Mantel-Haenszel|||||||0.4010
71102659|NCT00967499|141713958|SUPERIORITY|||||||0.5672|||||||Cochran-Mantel-Haenszel|||||||0.5672
71102660|NCT00967499|141713959|SUPERIORITY|||||||0.057|||||||Cochran-Mantel-Haenszel|||||||0.0570
71102661|NCT00967499|141713960|SUPERIORITY|||||||0.515|||||||Cochran-Mantel-Haenszel|||||||0.5150
71102662|NCT00967499|141713961|SUPERIORITY|||||||0.3601||||||P-values are based on Cochran-Mantel-Haenszel row mean score test with gender adjustment for the ranks of the change from baseline values.|Cochran-Mantel-Haenszel|||||||0.3601
71102663|NCT00967499|141713962|SUPERIORITY|||||||0.3453|||||||Mann-Whitney Test|||24 hours postdose||||0.3453
71102664|NCT00967499|141713962|SUPERIORITY|||||||0.7874|||||||Mann-Whitney Test|||48 hours postdose||||0.7874
71102665|NCT00967499|141713962|SUPERIORITY|||||||0.8485|||||||Mann-Whitney Test|||72 Hours Postdose||||0.8485
71102666|NCT04562090|141713978|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-3.73|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-4.3|-3.16||Repeated Measures Analysis (RMA): CFB as response, treatment group (TG), visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of micturitions per 24 hours at baseline as covariate.|MMRM|||Week 12||-3.16|-4.30|<0.001
71102667|NCT04562090|141713981|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-2.62|STANDARD_ERROR_OF_MEAN|0.32|<|0.001|TWO_SIDED|95.0|-3.25|-1.99||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-1.99|-3.25|<0.001
71102668|NCT04562090|141713981|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-2.47|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-2.93|-2.02||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-2.02|-2.93|<0.001
71102669|NCT04562090|141713981|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-3.13|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-3.96|-2.3||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-2.30|-3.96|<0.001
71102670|NCT04562090|141713981|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-2.93|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-3.39|-2.47||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-2.47|-3.39|<0.001
71102671|NCT04562090|141713981|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-3.47|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|-4.37|-2.56||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-2.56|-4.37|<0.001
71102672|NCT04562090|141713981|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-3.59|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-4.06|-3.12||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-3.12|-4.06|<0.001
71102673|NCT04562090|141713982|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.66|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.88|-0.44||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-0.44|-0.88|<0.001
71102674|NCT04562090|141713982|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.81|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.97|-0.65||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-0.65|-0.97|<0.001
71102675|NCT04562090|141713982|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.88|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-1.17|-0.58||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-0.58|-1.17|<0.001
71102676|NCT04562090|141713982|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.94|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-1.1|-0.78||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-0.78|-1.10|<0.001
71102677|NCT04562090|141713982|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.03|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.35|-0.71||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-0.71|-1.35|<0.001
71102678|NCT04562090|141713982|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.98|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-1.14|-0.81||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-0.81|-1.14|<0.001
71102679|NCT04562090|141713983|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.48|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.58|-0.37||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-0.37|-0.58|<0.001
71102680|NCT04562090|141713983|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.46|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|95.0|-0.53|-0.38||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-0.38|-0.53|<0.001
71102681|NCT04562090|141713983|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.53|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.67|-0.39||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-0.39|-0.67|<0.001
71102682|NCT04562090|141713983|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.45|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|95.0|-0.52|-0.37||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-0.37|-0.52|<0.001
71102683|NCT04562090|141713983|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.53|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.68|-0.38||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-0.38|-0.68|<0.001
71102684|NCT04562090|141713983|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.52|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|95.0|-0.6|-0.45||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-0.45|-0.60|<0.001
71102685|NCT04562090|141713984|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.1|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-1.31|-0.9||RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-0.90|-1.31|<0.001
71102686|NCT04562090|141713984|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.11|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-1.25|-0.96||RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-0.96|-1.25|<0.001
71102687|NCT04562090|141713984|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.26|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.53|-0.99||RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-0.99|-1.53|<0.001
71102688|NCT04562090|141713984|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.2|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-1.34|-1.05||RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-1.05|-1.34|<0.001
71102689|NCT04562090|141713984|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.25|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-1.54|-0.96||RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-0.96|-1.54|<0.001
71102690|NCT04562090|141713984|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.27|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-1.42|-1.12||RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-1.12|-1.42|<0.001
71102691|NCT04562090|141713985|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-2.97|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-3.5|-2.43||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate.|MMRM|||Week 4||-2.43|-3.50|<0.001
71102692|NCT04562090|141713985|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-3.05|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-3.44|-2.65||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate.|MMRM|||Week 4||-2.65|-3.44|<0.001
71102693|NCT04562090|141713985|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-5.09|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-5.8|-4.39||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate.|MMRM|||Week 8||-4.39|-5.80|<0.001
71102694|NCT04562090|141713985|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-4.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-4.7|-3.9||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate.|MMRM|||Week 8||-3.90|-4.70|<0.001
71102695|NCT04562090|141713985|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-6.01|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-6.78|-5.24||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate.|MMRM|||Week 12||-5.24|-6.78|<0.001
71102696|NCT04562090|141713985|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-5.4|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|-5.82|-4.98||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate.|MMRM|||Week 12||-4.98|-5.82|<0.001
71102697|NCT04562090|141713986|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.97|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|-2.73|-1.21||RMA: CFB as response, TG, visit (week 4, 8), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of micturitions per 24 hours at baseline as covariate.|MMRM|||Week 4||-1.21|-2.73|<0.001
71102698|NCT04562090|141713986|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-2.36|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.9|-1.81||RMA: CFB as response, TG, visit (week 4, 8), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of micturitions per 24 hours at baseline as covariate.|MMRM|||Week 4||-1.81|-2.90|<0.001
71102699|NCT04562090|141713986|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-3.2|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|-4.2|-2.2||RMA: CFB as response, TG, visit (week 4, 8), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of micturitions per 24 hours at baseline as covariate.|MMRM|||Week 8||-2.20|-4.20|<0.001
71102700|NCT04562090|141713986|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-2.92|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-3.47|-2.37||RMA: CFB as response, TG, visit (week 4, 8), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of micturitions per 24 hours at baseline as covariate.|MMRM|||Week 8||-2.37|-3.47|<0.001
71102701|NCT03312543|141714014|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.18|STANDARD_DEVIATION|0.328|<|0.001|TWO_SIDED|95.0|0.09|0.26|||t-test, 2 sided|||||0.26|0.09|<0.001
71009051|NCT02519777|141525760|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 48 from baseline||||0.61
71009052|NCT02519777|141525762|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in normalized composite neurocognitive test scores at Week 24 from baseline||||0.61
71009053|NCT02519777|141525762|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in normalized composite neurocognitive test scores at Week 72 from baseline||||0.72
71009054|NCT02519777|141525762|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in normalized composite neurocognitive test scores at Week 96 from baseline||||0.79
71009055|NCT02519777|141525762|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 24 from baseline||||0.55
71009056|NCT02519777|141525762|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 72 from baseline||||0.47
71009057|NCT02519777|141525762|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 96 from baseline||||0.95
71009058|NCT02519777|141525762|SUPERIORITY|||||||0.85|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 24 from baseline||||0.85
71009059|NCT02519777|141525762|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 72 from baseline||||0.67
71009060|NCT02519777|141525762|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 96 from baseline||||0.70
71045629|NCT02697773|141599474|SUPERIORITY||Least Square Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.08||0.0498|TWO_SIDED|95.0|-0.31|0.0|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||-0.00|-0.31|0.0498
71045630|NCT02697773|141599474|SUPERIORITY||Least Square Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.08||0.238|TWO_SIDED|95.0|-0.24|0.06|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||0.06|-0.24|0.2380
71045631|NCT02697773|141599474|SUPERIORITY||Least Square Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.09||0.0426|TWO_SIDED|95.0|-0.34|-0.01|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||-0.01|-0.34|0.0426
71102702|NCT03312543|141714014|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.3|STANDARD_DEVIATION|0.341|<|0.001|TWO_SIDED|95.0|0.21|0.39|||t-test, 2 sided|||||0.39|0.21|<0.001
71009061|NCT02519777|141525763|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in functional status scores at Week 24 from baseline||||0.99
71009062|NCT02519777|141525763|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in functional status scores at Week 48 from baseline||||0.97
71009063|NCT02519777|141525763|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in functional status scores at Week 72 from baseline||||0.79
71009064|NCT02519777|141525763|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in functional status scores at Week 96 from baseline||||0.99
71009065|NCT02519777|141525763|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in functional status scores at Week 24 from baseline||||0.74
71009066|NCT02519777|141525763|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in functional status scores at Week 48 from baseline||||0.69
71009067|NCT02519777|141525763|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in functional status scores at Week 72 from baseline||||0.44
71102703|NCT03312543|141714014|OTHER|The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.06||0.025|TWO_SIDED|95.0|0.02|0.25|||ANCOVA|With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate.||||0.25|0.02|0.025
71009068|NCT02519777|141525763|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in functional status scores at Week 96 from baseline||||1.00
71009069|NCT02519777|141525763|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in functional status scores at Week 24 from baseline||||0.83
71009070|NCT02519777|141525763|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in functional status scores at Week 48 from baseline||||0.80
71009071|NCT02519777|141525763|SUPERIORITY|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in functional status scores at Week 72 from baseline||||0.86
71009072|NCT02519777|141525763|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in functional status scores at Week 96 from baseline||||1.00
71009073|NCT02519777|141525764|SUPERIORITY||Difference in Percentage of Participants|3.32|||||TWO_SIDED|95.0|-2.78|9.42||||||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 24||9.42|-2.78|
71009074|NCT02519777|141525764|SUPERIORITY||Difference in Percentage of Participants|5.17|||||TWO_SIDED|95.0|-0.53|10.87||||||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48||10.87|-0.53|
71009075|NCT02519777|141525764|SUPERIORITY||Difference in Percentage of Participants|-8.21|||||TWO_SIDED|95.0|-16.56|0.13||||||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96||0.13|-16.56|
71009076|NCT02519777|141525764|SUPERIORITY||Difference in Percentage of Participants|3.17|||||TWO_SIDED|95.0|-3.07|9.42||||||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 24||9.42|-3.07|
71009077|NCT02519777|141525764|SUPERIORITY||Difference in Percentage of Participants|3.48|||||TWO_SIDED|95.0|-3.11|10.06||||||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48||10.06|-3.11|
71009078|NCT02519777|141525764|SUPERIORITY||Difference in Percentage of Participants|-1.85|||||TWO_SIDED|95.0|-7.89|4.19||||||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96||4.19|-7.89|
71009079|NCT02519777|141525764|SUPERIORITY||Difference in Percentage of Participants|-0.15|||||TWO_SIDED|95.0|-4.53|4.23||||||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 24||4.23|-4.53|
71009080|NCT02519777|141525764|SUPERIORITY||Difference in Percentage of Participants|-1.69|||||TWO_SIDED|95.0|-4.99|1.6||||||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48||1.60|-4.99|
71009081|NCT02519777|141525764|SUPERIORITY||Difference in Percentage of Participants|6.36|||||TWO_SIDED|95.0|-2.7|15.42||||||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96||15.42|-2.70|
71009082|NCT02519777|141525766|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in CD4+ T-cell count at Week 24 from baseline||||0.67
71009083|NCT02519777|141525766|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in CD4+ T-cell count at Week 48 from baseline||||0.78
71009084|NCT02519777|141525766|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in CD4+ T-cell count at Week 96 from baseline||||0.94
71009085|NCT02519777|141525766|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 24 from baseline||||0.42
71009086|NCT02519777|141525766|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 48 from baseline||||0.07
71009087|NCT02519777|141525766|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 96 from baseline||||0.37
71009088|NCT02519777|141525766|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 24 from baseline||||0.08
71009089|NCT02519777|141525766|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 48 from baseline||||0.33
71045632|NCT02697773|141599474|SUPERIORITY||Least Square Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.09||0.0014|TWO_SIDED|95.0|-0.45|-0.11|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||-0.11|-0.45|0.0014
71045633|NCT02697773|141599476|SUPERIORITY||Odds Ratio (OR)|1.78||||0.0027|TWO_SIDED|95.0|1.22|2.61|||Regression, Logistic|||Week 2: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.61|1.22|0.0027
71045634|NCT02697773|141599476|SUPERIORITY||Odds Ratio (OR)|1.98||||0.0004|TWO_SIDED|95.0|1.36|2.89|||Regression, Logistic|||Week 2: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.89|1.36|0.0004
71045635|NCT02697773|141599476|SUPERIORITY||Odds Ratio (OR)|1.98||||0.0008|TWO_SIDED|95.0|1.33|2.95|||Regression, Logistic|||Week 4: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.95|1.33|0.0008
71045636|NCT02697773|141599476|SUPERIORITY||Odds Ratio (OR)|2.04||||0.0004|TWO_SIDED|95.0|1.37|3.04|||Regression, Logistic|||Week 4: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.04|1.37|0.0004
71045637|NCT02697773|141599476|SUPERIORITY||Odds Ratio (OR)|1.27||||0.2283|TWO_SIDED|95.0|0.86|1.87|||Regression, Logistic|||Week 8: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.87|0.86|0.2283
71045638|NCT02697773|141599476|SUPERIORITY||Odds Ratio (OR)|1.38||||0.1066|TWO_SIDED|95.0|0.93|2.03|||Regression, Logistic|||Week 8: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.03|0.93|0.1066
71045639|NCT02697773|141599476|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0154|TWO_SIDED|95.0|1.1|2.54|||Regression, Logistic|||Week 12: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.54|1.10|0.0154
71045640|NCT02697773|141599476|SUPERIORITY||Odds Ratio (OR)|2.13||||0.0006|TWO_SIDED|95.0|1.38|3.27|||Regression, Logistic|||Week 12: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.27|1.38|0.0006
71045641|NCT02697773|141599476|SUPERIORITY||Odds Ratio (OR)|1.39||||0.1139|TWO_SIDED|95.0|0.92|2.07|||Regression, Logistic|||Week 16: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.07|0.92|0.1139
71045642|NCT02697773|141599476|SUPERIORITY||Odds Ratio (OR)|1.99||||0.0014|TWO_SIDED|95.0|1.31|3.04|||Regression, Logistic|||Week 16: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.04|1.31|0.0014
71045643|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0009|TWO_SIDED|95.0|1.3|2.78|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.78|1.30|0.0009
71045644|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|1.99||||0.0004|TWO_SIDED|95.0|1.36|2.9|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.90|1.36|0.0004
71045645|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|1.95||||0.0015|TWO_SIDED|95.0|1.29|2.96|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.96|1.29|0.0015
71045646|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|2.03||||0.0008|TWO_SIDED|95.0|1.34|3.07|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.07|1.34|0.0008
71045647|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0251|TWO_SIDED|95.0|1.07|2.75|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.75|1.07|0.0251
71045648|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0276|TWO_SIDED|95.0|1.06|2.72|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.72|1.06|0.0276
71009090|NCT02519777|141525766|SUPERIORITY|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 96 from baseline||||0.56
71009091|NCT02519777|141525768|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in CD8+ T-cell count at Week 24 from baseline||||0.63
71102704|NCT03312543|141714015|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.2|STANDARD_DEVIATION|0.349|<|0.001|TWO_SIDED|95.0|0.11|0.29|||t-test, 2 sided|||||0.29|0.11|<0.001
71102705|NCT03312543|141714015|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.22|STANDARD_DEVIATION|0.328|<|0.001|TWO_SIDED|95.0|0.13|0.31|||t-test, 2 sided|||||0.31|0.13|<0.001
71102706|NCT03312543|141714015|EQUIVALENCE|The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.062||0.54|TWO_SIDED|95.0|-0.09|0.16|||ANCOVA|With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate.||||0.16|-0.09|0.540
71102707|NCT03312543|141714016|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|-0.03|STANDARD_DEVIATION|0.532||0.627|TWO_SIDED|95.0|-0.17|0.1|||t-test, 2 sided|||||0.10|-0.17|0.627
71102708|NCT03312543|141714016|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.21|STANDARD_DEVIATION|0.5||0.002|TWO_SIDED|95.0|0.08|0.34|||t-test, 2 sided|||||0.34|0.08|0.002
71102709|NCT03312543|141714016|EQUIVALENCE|The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells.|Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.092||0.009|TWO_SIDED|95.0|0.06|0.42|||ANCOVA|With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate.||||0.42|0.06|0.009
71102710|NCT03312543|141714017|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.36|STANDARD_DEVIATION|0.465|<|0.001|TWO_SIDED|95.0|0.23|0.48|||t-test, 2 sided|||||0.48|0.23|<0.001
71102711|NCT03312543|141714017|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.47|STANDARD_DEVIATION|0.578|<|0.001|TWO_SIDED|95.0|0.32|0.63|||t-test, 2 sided|||||0.63|0.32|<0.001
71102712|NCT03312543|141714017|EQUIVALENCE|The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells.|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.094||0.224|TWO_SIDED|95.0|-0.07|0.3|||ANCOVA|With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate.||||0.30|-0.07|0.224
71102713|NCT05535972|141714049|OTHER||Least Square Mean|-6.81|STANDARD_ERROR_OF_MEAN|0.241|||TWO_SIDED|95.0|-7.28|-6.33|||||CFB in CAT score was analyzed using Mixed Model Repeated Measures(MMRM) model with covariates of smoking status, CAT score at Baseline, visit, interaction of CAT score at Baseline\*visit. Estimates derived from inverse probability weighted MMRM model.|||-6.33|-7.28|
71102714|NCT04197583|141714065|OTHER||Proportion by group|0.984|||||TWO_SIDED|95.0|0.948|0.995|||||For Tria subjects with stone management indication only|||0.995|0.948|
71102715|NCT05852470|141714071|NON_INFERIORITY|Non-inferiority margin = 0.1 logMAR|Difference in Means|0.034|STANDARD_ERROR_OF_MEAN|0.0167|||TWO_SIDED|95.0|0.001|0.067||Since a non-inferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the non-inferiority margin.|||Parameter Dispersion Type is Standard Error of the Difference in Means. Difference = Vivity/Vivity Toric Extended Vision IOL minus Clareon/Clareon Toric Monofocal IOL|||0.067|0.001|
71009092|NCT02519777|141525768|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in CD8+ T-cell count at Week 48 from baseline||||0.38
71009093|NCT02519777|141525768|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in CD8+ T-cell count at Week 96 from baseline||||0.95
71102716|NCT05852470|141714072|SUPERIORITY||Difference in Means|-0.091|STANDARD_ERROR_OF_MEAN|0.0151|<|0.001|TWO_SIDED|95.0|-0.12|-0.061|||t-test, 1 sided||||Parameter Dispersion Type is Standard Error of the Difference in Means. Difference = Vivity/Vivity Toric Extended Vision IOL minus Clareon/Clareon Toric Monofocal IOL|-0.061|-0.120|<.001
71102717|NCT05852470|141714073|SUPERIORITY||Difference in Means|-0.129|STANDARD_ERROR_OF_MEAN|0.0202|<|0.001|TWO_SIDED|95.0|-0.169|-0.089|||t-test, 1 sided||Parameter Dispersion Type is Standard Error of the Difference in Means. Difference = Vivity/Vivity Toric Extended Vision IOL minus Clareon/Clareon Toric Monofocal IOL|||-0.089|-0.169|<.001
71102718|NCT05852470|141714074|SUPERIORITY||Difference in Percentages|17.32|||||TWO_SIDED|90.0|8.66||Upper limit is not applicable for testing.|The lower boundary of the confidence interval is reported instead of a p-value.|Miettinen-Nurminen||Difference = Vivity/Vivity Toric Extended Vision IOL minus Clareon/Clareon Toric Monofocal IOL||||8.66|
70925920|NCT05492318|141345719|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 17) and the Geometric Lsmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|62.18|||||TWO_SIDED|90.0|50.86|75.95||||||Free Dabigatran: Potential Induction Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate. Cmax||75.95|50.86|
70925921|NCT05492318|141345724|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the geometric LS means|107.35|||||TWO_SIDED|90.0|103.35|111.49||||||Midazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Midazolam IV - AUC0-t||111.49|103.35|
70925922|NCT05492318|141345724|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|106.18|||||TWO_SIDED|90.0|100.84|111.8||||||1-Hydroxymidazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Midazolam IV - AUC0-t||111.80|100.84|
71009094|NCT02519777|141525768|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 24 from baseline||||0.27
71102719|NCT00323622|141714100|SUPERIORITY_OR_OTHER||1 - (HR1/HR2)|16.8||||0.08|TWO_SIDED|95.0|-2.5|32.4||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 21-33 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - GSK RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||32.40|-2.50|0.08
71102720|NCT00323622|141714100|SUPERIORITY_OR_OTHER||1 - (HR1/HR2)|11.8||||0.43|TWO_SIDED|95.0|-20.11|35.18||The p-value presented is the Wald Chi-square p-value from the Cox regression model|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 33-45 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||35.18|-20.11|0.43
70925923|NCT05492318|141345724|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|121.77|||||TWO_SIDED|90.0|117.56|126.12||||||Midazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Midazolam IV - AUC0-t||126.12|117.56|
70925924|NCT05492318|141345724|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|122.97|||||TWO_SIDED|90.0|115.08|131.41||||||1-Hydroxymidazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Midazolam IV - AUC0-t||131.41|115.08|
70925925|NCT05492318|141345724|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 7) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|137.42|||||TWO_SIDED|90.0|128.09|147.43||||||Midazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - AUC0-t||147.43|128.09|
70925926|NCT05492318|141345724|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 7) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|131.21|||||TWO_SIDED|90.0|122.47|140.59||||||1-Hydroxymidazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - AUC0-t||140.59|122.47|
71009095|NCT02519777|141525768|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 48 from baseline||||0.23
71009096|NCT02519777|141525768|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 96 from baseline||||0.09
70925927|NCT05492318|141345724|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 18) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|157.77|||||TWO_SIDED|90.0|147.49|168.76||||||Midazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Oral Midazolam. - AUC0-t||168.76|147.49|
70925928|NCT05492318|141345724|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 18) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|158.3|||||TWO_SIDED|90.0|145.23|172.54||||||1-Hydroxymidazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Oral Midazolam: - AUC0-t||172.54|145.23|
70925929|NCT05492318|141345725|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|69.9|||||TWO_SIDED|90.0|58.43|83.64||||||Total Dabigatran: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics - AUC0-t||83.64|58.43|
70925930|NCT05492318|141345725|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|71.43|||||TWO_SIDED|90.0|58.67|86.98||||||Free Dabigatran: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - AUC0-t||86.98|58.67|
70925931|NCT05492318|141345725|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|69.94|||||TWO_SIDED|90.0|58.82|83.15||||||Total Dabigatran: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - AUC0-t||83.15|58.82|
70925932|NCT05492318|141345725|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 17) and the Geometric Lsmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|72.3|||||TWO_SIDED|90.0|59.92|87.25||||||Free Dabigatran: Potential Induction Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - AUC0-t||87.25|59.92|
70925933|NCT05492318|141345726|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|107.55|||||TWO_SIDED|90.0|103.35|111.49||||||Midazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Midazolam IV: AUC0-inf||111.49|103.35|
71009097|NCT02519777|141525768|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 24 from baseline||||0.03
71009098|NCT02519777|141525768|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 48 from baseline||||0.02
71009099|NCT02519777|141525768|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 96 from baseline||||0.09
71009100|NCT02519777|141525769|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 sCD14 in plasma at Week 48 from baseline||||1.00
71009101|NCT02519777|141525769|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 sCD14 in plasma at Week 48 from baseline||||0.95
71009102|NCT02519777|141525769|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 sCD14 in plasma at Week 48 from baseline||||0.96
71009103|NCT02519777|141525770|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 MIP-1 Beta in plasma at Week 48 from baseline||||0.52
71009104|NCT02519777|141525770|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 MIP-1 Beta in plasma at Week 48 from baseline||||<0.01
71009105|NCT02519777|141525770|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 MIP-1 Beta in plasma at Week 48 from baseline||||<0.01
71009106|NCT02519777|141525771|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 sTNFr-II in plasma at Week 48 from baseline||||0.91
71009107|NCT02519777|141525771|SUPERIORITY|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 sTNFr-II in plasma at Week 48 from baseline||||0.86
71009108|NCT02519777|141525771|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 sTNFr-II in plasma at Week 48 from baseline||||0.94
71009109|NCT02519777|141525772|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 VCAM in plasma at Week 48 from baseline||||0.70
71009110|NCT02519777|141525772|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 VCAM in plasma at Week 48 from baseline||||0.28
71009111|NCT02519777|141525772|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 VCAM in plasma at Week 48 from baseline||||0.85
71009112|NCT02519777|141525773|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 MIP-1 Beta in CSF at Week 48 from baseline||||0.99
71009113|NCT02519777|141525773|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 MIP-1 Beta in CSF at Week 48 from baseline||||0.26
71009114|NCT02519777|141525773|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 MIP-1 Beta in CSF at Week 48 from baseline||||0.20
71009115|NCT02519777|141525774|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 IP-10 in CSF at Week 48 from baseline||||0.59
71009116|NCT02519777|141525774|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 IP-10 in CSF at Week 48 from baseline||||0.39
71009117|NCT02519777|141525774|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 IP-10 in CSF at Week 48 from baseline||||0.80
71009118|NCT02519777|141525775|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 Neopterin in CSF at Week 48 from baseline||||0.90
71009119|NCT02519777|141525775|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 Neopterin in CSF at Week 48 from baseline||||0.14
71009120|NCT02519777|141525775|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 Neopterin in CSF at Week 48 from baseline||||0.49
71009121|NCT02519777|141525776|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 NFL in CSF at Week 48 from baseline||||0.52
71009122|NCT02519777|141525776|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 NFL in CSF at Week 48 from baseline||||0.99
71009123|NCT02519777|141525776|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 NFL in CSF at Week 48 from baseline||||0.54
71009124|NCT04542525|141525792|SUPERIORITY||||||<|0.0001|||||||Exact Test of Binomial Proportion||||P-value is provided from exact test of binomial proportion (one-sided alpha = 2.5%) comparing PanOptix Toric Trifocal IOL Model TFNT20 with historical threshold 29.2 % (rate calculated for a non-toric IOL in Japanese study patients that would qualify for a T2 lens using the same toric calculator).|||<0.0001
71009125|NCT00545740|141525795|SUPERIORITY_OR_OTHER_LEGACY|||||||0.063||95.0|||||Cochran-Mantel-Haenszel|||||||0.063
71009126|NCT00545740|141525795|SUPERIORITY_OR_OTHER_LEGACY|||||||0.736||95.0|||||Cochran-Mantel-Haenszel|||||||0.736
71045649|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|1.95||||0.0404|TWO_SIDED|95.0|1.03|3.71|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.71|1.03|0.0404
71009127|NCT00545740|141525795|SUPERIORITY_OR_OTHER_LEGACY|||||||0.78||95.0|||||Cochran-Mantel-Haenszel|||||||0.780
71009128|NCT00545740|141525797|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047||95.0|||||Cochran-Mantel-Haenszel|||||||0.047
71009129|NCT00545740|141525797|SUPERIORITY_OR_OTHER_LEGACY|||||||0.741||95.0|||||Cochran-Mantel-Haenszel|||||||0.741
71009130|NCT00545740|141525797|SUPERIORITY_OR_OTHER_LEGACY|||||||0.78||95.0|||||Cochran-Mantel-Haenszel|||||||0.780
71009131|NCT02625610|141525802|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.1779|TWO_SIDED|95.0|0.74|1.11|||Log Rank|The treatment arms were compared using a stratified, 1-sided, log rank Test. The stratification factor was region (Asia versus non Asia).||||1.11|0.74|0.1779
71009132|NCT02625610|141525803|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.85|1.28||||||||1.28|0.85|
71009133|NCT02625610|141525805|SUPERIORITY||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.55|1.51||||||||1.51|0.55|
71009134|NCT00082628|141525815|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Nonparametric ANCOVA Model|||||||<0.001
71009135|NCT03459794|141525821|OTHER|||||||||||||||||All measurements were compared to the same group at t=0, that is before the drug or placebo was administered. We compared the expression levels for each transcript, using the mean levels in each group, not at the individual participant level.|We analyzed the changes is level for each cytokine between the groups. P value was adjusted for multiple comparisons and significance determined using the Holm-Sidak method. The threshold value for statistical significance for the mean value between groups was set at p =\<0.05 for each cytokine measured. The number of cytokines that met this threshold is reported.|||
71009136|NCT03459794|141525822|OTHER|||||||||||||||||All measurements were compared to the same treated/control group at t=0, before the drug or placebo was administered. We compared the expression levels for each transcript, using the mean levels in each group, not at the individual participant level.|We compared the expression levels for each transcript, using the mean levels in each group, not at the individual participant level. The p-value for each transcript is adjusted for multiple comparisons across all 770 transcripts, using the Benjamini-Yekutieli method. The number reported is the number of transcripts where p=\<0.05.|||
71009137|NCT03459794|141525823|OTHER||||||<|0.05|||||||t-test, 1 sided|||||||<0.05
71009138|NCT02177942|141525824|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.6931|TWO_SIDED|95.0|-0.2|0.13|||ANCOVA||Difference is test treatment minus control treatment such that a positive difference favours the test treatment.|||0.13|-0.20|0.6931
71045650|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|1.38||||0.3486|TWO_SIDED|95.0|0.7|2.72|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.72|0.70|0.3486
71045651|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|2.07||||0.0002|TWO_SIDED|95.0|1.42|3.02|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.02|1.42|0.0002
71045652|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|1.92||||0.0006|TWO_SIDED|95.0|1.32|2.79|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.79|1.32|0.0006
71045653|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|2.07||||0.0002|TWO_SIDED|95.0|1.41|3.05|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.05|1.41|0.0002
71045654|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|2.15|||<|0.0001|TWO_SIDED|95.0|1.46|3.15|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.15|1.46|<.0001
71045655|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|2.02||||0.0024|TWO_SIDED|95.0|1.28|3.18|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.18|1.28|0.0024
71045656|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|2.13||||0.0011|TWO_SIDED|95.0|1.35|3.34|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.34|1.35|0.0011
71045657|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|2.06||||0.0172|TWO_SIDED|95.0|1.14|3.72|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.72|1.14|0.0172
71045658|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|2.06||||0.0173|TWO_SIDED|95.0|1.14|3.72|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.72|1.14|0.0173
71045659|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|1.62||||0.0118|TWO_SIDED|95.0|1.11|2.35|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.35|1.11|0.0118
71045660|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0132|TWO_SIDED|95.0|1.1|2.32|||Regression, Logistic|||Week 8, \>=30%:Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.32|1.10|0.0132
71045661|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|1.99||||0.0005|TWO_SIDED|95.0|1.35|2.92|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.92|1.35|0.0005
71117587|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.34||||0.125|TWO_SIDED|95.0|-2.2|18.87||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.87|-2.20|0.125
71045662|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|1.66||||0.01|TWO_SIDED|95.0|1.13|2.45|||Regression, Logistic|||Week 8, \>=50%:Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.45|1.13|0.0100
71045663|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0023|TWO_SIDED|95.0|1.28|3.12|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.12|1.28|0.0023
71045664|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0322|TWO_SIDED|95.0|1.04|2.58|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.58|1.04|0.0322
71045665|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|1.48||||0.2005|TWO_SIDED|95.0|0.81|2.67|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.67|0.81|0.2005
71045666|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|1.48||||0.1923|TWO_SIDED|95.0|0.82|2.68|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.68|0.82|0.1923
71045667|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|1.89||||0.0013|TWO_SIDED|95.0|1.28|2.79|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.79|1.28|0.0013
71045668|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|2.5|||<|0.0001|TWO_SIDED|95.0|1.68|3.73|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.73|1.68|<.0001
71009139|NCT01351415|141525833|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.84||||0.1044|TWO_SIDED|90.0|0.71|1.0|||Stratified Log-Rank test|||The stratification factors for Log-Rank test and Hazard Ratio (HR) are the type of planned 2nd-line SoC treatment, the number of cycles of bevacizumab maintenance treatment prior to first PD and smoking status.||1.00|0.71|0.1044
70925934|NCT05492318|141345726|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|112.17|||||TWO_SIDED|90.0|106.21|118.46||||||1-Hydroxymidazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Midazolam IV - AUC0-inf||118.46|106.21|
71102721|NCT00323622|141714101|SUPERIORITY_OR_OTHER||1 - (R1/R2)|14.9||||0.11|TWO_SIDED|95.0|-3.88|30.28||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 21-33 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||30.28|-3.88|0.11
71102722|NCT00323622|141714101|SUPERIORITY_OR_OTHER||1 - (R1/R2)|12.79||||0.35|TWO_SIDED|95.0|-16.27|34.59||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 33-45 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||34.59|-16.27|0.35
71102723|NCT00323622|141714102|SUPERIORITY_OR_OTHER||1 - (R1/R2)|19.42||||0.01|TWO_SIDED|95.0|4.62|31.93||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 21-33 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||31.93|4.62|0.01
71102724|NCT00323622|141714102|SUPERIORITY_OR_OTHER||1 - (R1/R2)|7.08||||0.54|TWO_SIDED|95.0|-17.37|26.44||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 33-45 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||26.44|-17.37|0.54
71102725|NCT00323622|141714103|SUPERIORITY_OR_OTHER||1 - (R1/R2)|16.79||||0.1|TWO_SIDED|95.0|-3.75|33.25||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 21-33 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||33.25|-3.75|0.10
71102726|NCT00323622|141714103|SUPERIORITY_OR_OTHER||1 - (R1/R2)|6.31||||0.7|TWO_SIDED|95.0|-31.0|32.99||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 33-45 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||32.99|-31.00|0.70
71045669|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|2.12|||<|0.0001|TWO_SIDED|95.0|1.45|3.1|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.10|1.45|<.0001
70925935|NCT05492318|141345726|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|124.01|||||TWO_SIDED|90.0|119.44|128.76||||||Midazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Midazolam IV - AUC0-inf||128.76|119.44|
71045670|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|1.84||||0.0014|TWO_SIDED|95.0|1.26|2.67|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.67|1.26|0.0014
71009140|NCT01351415|141525834|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.83||||0.0573|TWO_SIDED|90.0|0.7|0.98|||Stratified Log-Rank test|||PFS 2: The stratification factors for Log-Rank test are the type of planned 2nd-line SoC treatment, the number of cycles of bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.98|0.70|0.0573
71009141|NCT01351415|141525834|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.63||||0.0045|TWO_SIDED|90.0|0.49|0.83|||Stratified Log-Rank test|||PFS 3: The stratification factors for Log-Rank test are the type of planned 2nd-line SoC treatment, the number of cycles of bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.83|0.49|0.0045
71009142|NCT01351415|141525835|SUPERIORITY_OR_OTHER||Estimated difference in response rate|0.0237||||0.081|TWO_SIDED|90.0|-0.0156|0.063|||Stratified Cochran-Mantel-Haenszel test|||The stratification factors for Cochran-Mantel-Haenszel test are the type of planned 2nd-line SoC treatment, the number of cycles of Bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.0630|-0.0156|0.0810
71009143|NCT01351415|141525836|SUPERIORITY_OR_OTHER||Estimated difference in Disease Control|0.0326||||0.0218|TWO_SIDED|90.0|-0.0288|0.094|||Stratified Cochran-Mantel-Haenszel test|||The stratification factors for Cochran-Mantel-Haenszel test are the type of planned 2nd-line SoC treatment, the number of cycles of Bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.0940|-0.0288|0.0218
71009144|NCT01351415|141525837|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.29||||0.06|TWO_SIDED|90.0|0.09|0.9|||Stratified Log-Rank test|||The stratification factors for Log-Rank test are the type of planned 2nd-line SoC treatment, the number of cycles of Bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.90|0.09|0.0600
71009145|NCT01351415|141525839|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.79||||0.0311|TWO_SIDED|90.0|0.65|0.95|||Stratified Log-Rank test|||TTP2: The stratification factors for Log-Rank test are the type of planned 2nd-line SoC treatment, the number of cycles of Bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.95|0.65|0.0311
71009146|NCT01351415|141525839|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.69||||0.0326|TWO_SIDED|90.0|0.52|0.92|||Stratified Log-Rank test|||TTP3: The stratification factors for Log-Rank test are the type of planned 2nd-line SoC treatment, the number of cycles of Bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.92|0.52|0.0326
71009147|NCT01234337|141525841|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.973|||=|0.405618|TWO_SIDED|95.0|0.779|1.217||One-sided p-value from log rank test (stratified per randomization as in interactive voice response system \[IVRS\]).|Log Rank|||PFS was compared using a stratified log-rank test with a one-sided alpha of 0.005, stratified by region, hormone receptor status, number of previous chemotherapies for metastatic disease. The hazard ratio (sorafenib + capecitabine / placebo + capecitabine) and its 95 percent (%) CIs were calculated using the Cox model, stratified by the above factors. A Hazard ratio of less than (\<) 1 indicates superiority of Sorafenib + Capecitabine over Placebo + Capecitabine.||1.217|0.779|=0.405618
71009148|NCT01234337|141525842|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.195|||=|0.930088|TWO_SIDED|95.0|0.943|1.513||One-sided p-value from log rank test (stratified per randomization as in IVRS). OS was compared using a stratified log-rank test, stratified by region, hormone receptor status, number of previous chemotherapies for metastatic disease.|Log Rank||The hazard ratio (sorafenib + capecitabine / placebo + capecitabine) and its 95% CIs were calculated using the Cox model, stratified by randomization factors.|At the time of PFS final analysis, it was OS interim analysis (IA) with 285 total death events. According to protocol specified O'Brien-Fleming type alpha spending function and 285 death events at IA, the prespecified alpha for this analysis was 0.0075 (one-sided). A Hazard ratio \< 1 indicates superiority of Sorafenib+Capecitabine over Placebo+Capecitabine.||1.513|0.943|=0.930088
71045671|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0008|TWO_SIDED|95.0|1.33|2.99|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.99|1.33|0.0008
71045672|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|2.05||||0.0005|TWO_SIDED|95.0|1.37|3.06|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.06|1.37|0.0005
71102727|NCT04191135|141714131|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.4556|TWO_SIDED|95.0|0.72|1.33||One-sided p-value based on log-rank test stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|Log Rank||Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|||1.33|0.72|0.4556
71102728|NCT04191135|141714132|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.3903|TWO_SIDED|95.0|0.64|1.4||One-sided p-value based on log-rank test stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|Log Rank||Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|||1.40|0.64|0.3903
71102729|NCT04191135|141714133|OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.59|1.43|||||Estimate based on stratified Cox model with Efron's method of tie handling with treatment as a covariate stratified by response to the induction therapy (CR or PR versus SD) and BRCA status (BRCAm versus BRCAwt).|||1.43|0.59|
71102730|NCT04191135|141714134|OTHER||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.53|1.76|||||Estimate based on stratified Cox model with Efron's method of tie handling with treatment as a covariate stratified by response to the induction therapy (CR or PR versus SD) and BRCA status (BRCAm versus BRCAwt).|||1.76|0.53|
71102731|NCT04191135|141714135|OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.33|1.48|||||Estimate based on stratified Cox model with Efron's method of tie handling with treatment as a covariate stratified by response to the induction therapy (CR or PR versus SD) and tumor PD-L1 status (CPS≥1 vs CPS\<1).|||1.48|0.33|
71102732|NCT04191135|141714136|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.28|2.37|||||Estimate based on stratified Cox model with Efron's method of tie handling with treatment as a covariate stratified by response to the induction therapy (CR or PR versus SD) and tumor PD-L1 status (CPS≥1 vs CPS\<1).|||2.37|0.28|
71102733|NCT04191135|141714137|SUPERIORITY||Difference in Least Squares Means|-3.28||||0.143|TWO_SIDED|95.0|-7.69|1.12|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||1.12|-7.69|0.1430
71102734|NCT04191135|141714138|SUPERIORITY||Difference in Least Squares Means|-0.16||||0.9454|TWO_SIDED|95.0|-4.89|4.56|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||4.56|-4.89|0.9454
71102735|NCT04191135|141714139|SUPERIORITY||Difference in Least Squares Means|2.08||||0.4351|TWO_SIDED|95.0|-3.16|7.31|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||7.31|-3.16|0.4351
70925936|NCT05492318|141345726|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|134.29|||||TWO_SIDED|90.0|126.15|142.96||||||1-Hydroxymidazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Midazolam IV. AUC0-inf||142.96|126.15|
71102736|NCT04191135|141714140|SUPERIORITY||Difference in Least Squares Means|0.93||||0.5588|TWO_SIDED|95.0|-2.2|4.06|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||4.06|-2.20|0.5588
71102737|NCT04191135|141714141|SUPERIORITY||Difference in Least Squares Means|-0.37||||0.8408|TWO_SIDED|95.0|-4.03|3.28|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||3.28|-4.03|0.8408
71102738|NCT04191135|141714142|SUPERIORITY||Difference in Least Squares Means|-1.34||||0.795|TWO_SIDED|95.0|-11.63|8.95|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||8.95|-11.63|0.7950
71102739|NCT04191135|141714143|SUPERIORITY||Difference in Least Squares Means|4.82||||0.1597|TWO_SIDED|95.0|-1.97|11.62|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||11.62|-1.97|0.1597
71102740|NCT04191135|141714144|SUPERIORITY||Difference in Least Squares Means|2.52||||0.6138|TWO_SIDED|95.0|-7.45|12.49|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||12.49|-7.45|0.6138
71102741|NCT04191135|141714145|SUPERIORITY||Difference in Least Squares Means|-1.6||||0.5567|TWO_SIDED|95.0|-7.02|3.83|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||3.83|-7.02|0.5567
71102742|NCT04191135|141714146|SUPERIORITY||Difference in Least Squares Means|5.56||||0.105|TWO_SIDED|95.0|-1.2|12.32|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||12.32|-1.20|0.1050
71102743|NCT04191135|141714147|SUPERIORITY||Hazard Ratio (HR)|1.78||||0.00676|TWO_SIDED|95.0|1.16|2.71|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|||2.71|1.16|0.00676
71102744|NCT04191135|141714148|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.96425|TWO_SIDED|95.0|0.61|1.69|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|||1.69|0.61|0.96425
71102745|NCT04191135|141714149|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.74965|TWO_SIDED|95.0|0.69|1.71|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|||1.71|0.69|0.74965
70925937|NCT05492318|141345726|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 7) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|138.75|||||TWO_SIDED|90.0|129.05|149.18||||||Midazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - AUC0-inf||149.18|129.05|
70925938|NCT05492318|141345726|OTHER||GMR corresponds to the ratio of the Geom|134.18|||||TWO_SIDED|90.0|124.19|144.97||||||1-Hydroxymidazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Oral Midazolam: AUC0-inf||144.97|124.19|
70925939|NCT05492318|141345726|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 18) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|162.76|||||TWO_SIDED|90.0|151.13|175.28||||||Midazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Oral Midazolam: AUC0-inf||175.28|151.13|
70925940|NCT05492318|141345726|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 18) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|161.2|||||TWO_SIDED|90.0|147.8|175.82||||||1-Hydroxymidazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - AUC0-inf||175.82|147.80|
71009149|NCT01234337|141525843|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91|||=|0.2105|TWO_SIDED|95.0|0.723|1.146||One-sided p-value from log rank test (stratified per randomization as in IVRS).|Log Rank||The hazard ratio (sorafenib + capecitabine / placebo + capecitabine) and its 95% CIs were calculated using the Cox model, stratified by the above factors.|TTP was compared using a stratified log-rank test with a one-sided alpha of 0.025, stratified by region, hormone receptor status, number of previous chemotherapies for metastatic disease. A Hazard ratio \<1 indicates superiority of Sorafenib+Capecitabine over Placebo+Capecitabine.||1.146|0.723|=0.2105
71102746|NCT04191135|141714150|SUPERIORITY||Hazard Ratio (HR)|1.76||||0.10502|TWO_SIDED|95.0|0.88|3.53|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|||3.53|0.88|0.10502
71102747|NCT04191135|141714151|SUPERIORITY||Hazard Ratio (HR)|1.31||||0.5019|TWO_SIDED|95.0|0.57|3.0|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), and tumor PD-L1 status (CPS ≥1 vs CPS \<1).|||3.00|0.57|0.50190
70925941|NCT05492318|141345727|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|69.96|||||TWO_SIDED|90.0|58.83|83.2||||||Total Dabigatran: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - AUC0-inf||83.20|58.83|
71009150|NCT01234337|141525844|SUPERIORITY_OR_OTHER||Percent Difference|1.93|||=|0.257412|TWO_SIDED|95.0|-3.9|7.77||One-sided p-value from Cochran Mantel-Haenszel test (stratified per randomization as in IVRS)|Cochran-Mantel-Haenszel|||ORR and 95% CI based on Cochran Mantel-Haenszel Test stratified by region, hormone receptor status, number of previous chemotherapies for metastatic disease. Difference = (Placebo + Capecitabine) - (Sorafenib + Capecitabine).||7.77|-3.9|=0.257412
71009151|NCT01234337|141525845|SUPERIORITY_OR_OTHER||Percent Difference|-2.34|||=|0.284674|TWO_SIDED|95.0|-10.4|5.72||One-sided p-value from Cochran-Mantel-Haenszel test (stratified per randomization as in IVRS).|Cochran-Mantel-Haenszel|||"DCR and 95% CI based on general association Cochran-Mantel-Haenszel statistic with one-sided alpha of 0.025 stratified by number of prior chemotherapies for metastatic disease, hormone receptor status, and region. Difference = Placebo + Capecitabine - Sorafenib + Capecitabine."||5.72|-10.4|=0.284674
71009152|NCT01234337|141525847|SUPERIORITY_OR_OTHER||LSM Difference|-0.441|||||TWO_SIDED|95.0|-0.967|0.086||||||Estimate of Difference (least squares mean \[LSM\] difference) = (Sorafenib + Capecitabine) - (Placebo + Capecitabine). The difference between the two treatment groups was evaluated with an analysis of covariance model using the baseline score and the same stratification factors as used for randomization (IVRS) as covariates.||0.086|-0.967|
71009153|NCT01234337|141525848|SUPERIORITY_OR_OTHER||LSM Difference|-0.025|||||TWO_SIDED|95.0|-0.053|0.002||||||Estimate of Difference (least squares mean \[LSM\] difference) = (Sorafenib + Capecitabine) - (Placebo + Capecitabine). The difference between the two treatment groups was evaluated with an analysis of covariance model using the baseline score and the same stratification factors as used for randomization (IVRS) as covariates.||0.002|-0.053|
71009154|NCT01234337|141525849|SUPERIORITY_OR_OTHER||LSM Difference|-1.696|||||TWO_SIDED|95.0|-3.619|0.227||||||Estimate of Difference (least squares mean \[LSM\] difference) = (Sorafenib + Capecitabine) - (Placebo + Capecitabine). The difference between the two treatment groups was evaluated with an analysis of covariance model using the baseline score and the same stratification factors as used for randomization (IVRS) as covariates.||0.227|-3.619|
71009155|NCT01234337|141525850|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|1.14|||||TWO_SIDED|90.0|0.92|1.4||||||Statistical analysis for Cmax: 5-fluorouracil||1.40|0.92|
71009156|NCT01234337|141525850|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|1.29|||||TWO_SIDED|90.0|1.07|1.56||||||Statistical analysis for Cmax: Capecitabine||1.56|1.07|
71009157|NCT01234337|141525851|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|1.11|||||TWO_SIDED|90.0|0.95|1.3||||||Statistical analysis for AUC(0-tlast): 5-fluorouracil||1.30|0.95|
71009158|NCT01234337|141525851|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|1.39|||||TWO_SIDED|90.0|1.22|1.58||||||Statistical analysis for AUC(0-tlast): Capecitabine||1.58|1.22|
71009159|NCT01646255|141525884|SUPERIORITY_OR_OTHER||Least Square Mean|-1.2|||=|0.0002|TWO_SIDED|95.0|-1.83|-0.57||Primary efficacy analyses was made with confirmatory 2-sided test with significance level 0.05.|ANCOVA|||"Estimate of treatment effect has been obtained from an analysis of covariance (ANCOVA) model to the change from Baseline value in absolute time spent off. The ANCOVA model contained treatment and (pooled) site as factors and Baseline off time as covariate. A last observation carried forward (LOCF) imputation approach was used for missing values (during both Titration and Maintenance Periods) for the primary efficacy analysis."||-0.57|-1.83|=0.0002
71009160|NCT02380703|141525903|SUPERIORITY||Hazard Ratio (HR)|1.34||||0.29|TWO_SIDED|95.0|0.78|2.32||For participants who dropped out, their time until study attrition was used as the exposure period; and they were carried forward as part of the overall incidence count.|Regression, Cox|||Sample-size calculations were performed, based on the ability to detect a small-to-moderate difference (Cohen's h = 0.4) in rate of aggression onset over a 1-year period between APT and EU-PC, assuming 80% power and a type I error rate of 5%. Given an anticipated rate of aggression onset over 1 year of 37% for EU-PC, an ES of h = 0.4 allows detection of aggression onset in APT as high as 19%. Given this effect size and up to 10% attrition, our goal was to include 220 total participants.||2.32|0.78|0.29
71009161|NCT02380703|141525903|EQUIVALENCE|Examination of whether the presence of aggression is equivalent between APT and EU-PC|Difference in frequencies|1.21||||0.27|TWO_SIDED|||||Association between presence of aggression and condition (APT vs EU-PC).|Chi-squared|X2(1) = 1.21||||||0.27
70925942|NCT05492318|141345727|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|71.65|||||TWO_SIDED|90.0|59.08|86.88||||||Free Dabigatran: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - AUC0-inf||86.88|59.08|
71102748|NCT04191135|141714152|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.47384|TWO_SIDED|95.0|0.24|1.97|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), and tumor PD-L1 status (CPS ≥1 vs CPS \<1).|||1.97|0.24|0.47384
71102749|NCT04191135|141714153|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.81463|TWO_SIDED|95.0|0.33|2.38|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), and tumor PD-L1 status (CPS ≥1 vs CPS \<1).|||2.38|0.33|0.81463
71102750|NCT04191135|141714154|SUPERIORITY||Hazard Ratio (HR)|1.47||||0.67255|TWO_SIDED|95.0|0.24|8.82|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), and tumor PD-L1 status (CPS ≥1 vs CPS \<1).|||8.82|0.24|0.67255
71102751|NCT03514134|141714157|SUPERIORITY||||||<|0.001|||||||ANCOVA|Repeated measures ANCOVA||||||<0.001
71102752|NCT03514134|141714158|SUPERIORITY|||||||0.358|||||||ANCOVA|Repeated measures ANCOVA||||||0.358
71102753|NCT03514134|141714159|SUPERIORITY|||||||0.029|||||||ANCOVA|Repeated measures ANCOVA||||||0.029
70925943|NCT05492318|141345727|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|70.37|||||TWO_SIDED|90.0|59.64|83.03||||||Total Dabigatran: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - AUC0-inf||83.03|59.64|
70925944|NCT05492318|141345727|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 17) and the Geometric Lsmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|73.45|||||TWO_SIDED|90.0|60.79|88.75||||||Free Dabigatran: Potential Induction Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate. AUC0-inf||88.75|60.79|
71102754|NCT03514134|141714160|SUPERIORITY||||||<|0.01|||||||Chi-squared|||||||<0.01
71102755|NCT03514134|141714160|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|||||||<0.05
71102756|NCT03514134|141714161|SUPERIORITY|||||||0.7||||||Group by time interaction|ANOVA|Repeated measures ANOVA||||||0.70
71102757|NCT02471144|141714162|SUPERIORITY||Odds Ratio (OR)|25.78|||<|0.0001|TWO_SIDED|95.0|7.08|114.66|||Regression, Logistic|||vs Placebo||114.66|7.08|<.0001
71102758|NCT02471144|141714162|SUPERIORITY||Odds Ratio (OR)|22.65|||<|0.0001|TWO_SIDED|95.0|6.31|98.93|||Regression, Logistic|||vs Placebo||98.93|6.31|<.0001
71102759|NCT02471144|141714163|SUPERIORITY||Odds Ratio (OR)|51.77|||<|0.0001|TWO_SIDED|95.0|10.02|538.64|||Regression, Logistic|||vs Placebo||538.64|10.02|<.0001
71102760|NCT02471144|141714163|SUPERIORITY||Odds Ratio (OR)|32.52|||<|0.0001||95.0|6.48|329.52|||Regression, Logistic|||vs Placebo||329.52|6.48|<.0001
71102761|NCT02471144|141714164|SUPERIORITY||Odds Ratio (OR)|72.5|||<|0.0001|TWO_SIDED|95.0|55.9|84.9|||Regression, Logistic|||vs Placebo||84.9|55.9|<.0001
71102762|NCT02471144|141714164|SUPERIORITY||Odds Ratio (OR)|67.5|||<|0.0001|TWO_SIDED|95.0|50.8|80.9|||Regression, Logistic|||vs Placebo||80.9|50.8|<.0001
71102763|NCT00107575|141714182|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Chi-squared|||||||>.05
71102764|NCT00107575|141714183|SUPERIORITY_OR_OTHER||expected count ratio|0.81||||0.027|TWO_SIDED|95.0|0.67|0.98||a priori p-value was p \< .05|generalized estimating equations|Negative binomial model controlling for sex, motivation to change drinking, and baseline drinking||||0.98|0.67|.027
71102765|NCT00107575|141714184|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Chi-squared|||||||.18
70941320|NCT00577096|141383062|NON_INFERIORITY_OR_EQUIVALENCE|T-test and chi-squared to check for equivalence of groups for age, race and gender.|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|||The null hypothesis was that there would be no difference between groups for the number of platelet transfusions.||||<0.025
71102766|NCT00107575|141714185|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||Chi-squared|||||||.95
71102767|NCT00107575|141714186|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||Chi-squared|||||||.76
71102768|NCT00775658|141714190|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Before the study, we determined that a sample size of 18 would be adequate to detect a 20% difference in wheal and flare areas with 80% power and a significance level of 0.05.||||0.57
71102769|NCT00775658|141714191|SUPERIORITY|Sample size determined that 18 participants would provide 80% power to detect a 20% difference with a significance level of 0.05.||||||0.09|||||||Wilcoxon (Mann-Whitney)|||||||0.09
71102770|NCT05796245|141714231|OTHER|Estimation|Cox Proportional Hazard|1.43|||||TWO_SIDED|95.0|0.39|5.2|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||5.20|0.39|
71102771|NCT05796245|141714231|OTHER|Estimation|Risk Ratio (RR)|1.43|||||TWO_SIDED|95.0|0.38|5.34|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||5.34|0.38|
71102772|NCT05796245|141714231|OTHER|Estimation|Risk Difference (RD)|0.04|||||TWO_SIDED|95.0|-0.2|0.11|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||0.11|-0.20|
71102773|NCT05796245|141714231|OTHER|Estimation|Cox Proportional Hazard|1.63|||||TWO_SIDED|95.0|0.54|4.9|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||4.90|0.54|
71102774|NCT05796245|141714231|OTHER|Estimation|Risk Ratio (RR)|1.71|||||TWO_SIDED|95.0|0.55|5.26|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||5.26|0.55|
71102775|NCT05796245|141714231|OTHER|Estimation|Risk Difference (RD)|0.09|||||TWO_SIDED|95.0|-0.1|0.39|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||0.39|-0.10|
71102776|NCT05796245|141714231|OTHER|Estimation|Cox Proportional Hazard|2.44|||||TWO_SIDED|95.0|1.05|5.67|||||Crude Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||5.67|1.05|
71102777|NCT05796245|141714231|OTHER|Estimation|Risk Ratio (RR)|2.47|||||TWO_SIDED|95.0|1.02|5.99|||||Crude Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||5.99|1.02|
71102778|NCT05796245|141714231|OTHER|Estimation|Risk Difference (RD)|0.13|||||TWO_SIDED|95.0|-0.06|0.32|||||Crude Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||0.32|-0.06|
71102779|NCT05796245|141714232|OTHER|Estimation|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-0.01|0.0|||||Crude Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set Note: Hazard ratio, risk ratio, and risk difference for the Comparative analysis set (IPTW weighted) and for the Comparative matched analysis set could not be calculated. Also, crude hazard ratio and crude risk ratio could not be calculated.||0.00|-0.01|
71102780|NCT05796245|141714233|OTHER|Estimation|Cox Proportional Hazard|1.22|||||TWO_SIDED|95.0|0.12|12.49|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||12.49|0.12|
71102781|NCT05796245|141714233|OTHER|Estimation|Risk Ratio (RR)|1.41|||||TWO_SIDED|95.0|0.12|17.14|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||17.14|0.12|
71009162|NCT02380703|141525904|SUPERIORITY||F-statistic|1.59||||0.19|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.19
71102782|NCT05796245|141714233|OTHER|Estimation|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-0.05|0.01|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||0.01|-0.05|
71102783|NCT05796245|141714233|OTHER|Estimation|Cox Proportional Hazard|6.12|||||TWO_SIDED|95.0|0.81|45.94|||||Crude Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set Note: Hazard ratio, risk ratio, and risk difference for the comparative matched analysis set could not be calculated.||45.94|0.81|
71102784|NCT05796245|141714233|OTHER|Estimation|Risk Ratio (RR)|7.07|||||TWO_SIDED|95.0|0.93|53.51|||||Crude Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||53.51|0.93|
71102785|NCT05796245|141714233|OTHER|Estimation|Risk Difference (RD)|0.03|||||TWO_SIDED|95.0|-0.04|0.1|||||Crude Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||0.10|-0.04|
71102786|NCT05796245|141714234|OTHER|Estimation|Cox Proportional Hazard|1.7|||||TWO_SIDED|95.0|0.16|17.61|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||17.61|0.16|
71102787|NCT05796245|141714234|OTHER|Estimation|Risk Ratio (RR)|1.85|||||TWO_SIDED|95.0|0.17|19.79|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||19.79|0.17|
71102788|NCT05796245|141714234|OTHER|Estimation|Risk Difference (RD)|0.01|||||TWO_SIDED|95.0|-0.12|0.03|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||0.03|-0.12|
71102789|NCT05796245|141714234|OTHER|Estimation|Cox Proportional Hazard|2.61|||||TWO_SIDED|95.0|0.15|45.68|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||45.68|0.15|
71102790|NCT05796245|141714234|OTHER|Estimation|Risk Ratio (RR)|2.01|||||TWO_SIDED|95.0|0.12|34.94|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||34.94|0.12|
71102791|NCT05796245|141714234|OTHER|Estimation|Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.1|0.26|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||0.26|-0.10|
71102792|NCT05796245|141714234|OTHER|Estimation|Cox Proportional Hazard|2.7|||||TWO_SIDED|95.0|0.37|19.93|||||Crude Hazard Ratio Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||19.93|0.37|
71045673|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|2.01||||0.0127|TWO_SIDED|95.0|1.16|3.49|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.49|1.16|0.0127
71045674|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|2.11||||0.0075|TWO_SIDED|95.0|1.22|3.64|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.64|1.22|0.0075
71045675|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0061|TWO_SIDED|95.0|1.17|2.52|||Regression, Logistic|||Week 16 \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.52|1.17|0.0061
71045676|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|1.95||||0.0007|TWO_SIDED|95.0|1.33|2.88|||Regression, Logistic|||Week 16 \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.88|1.33|0.0007
71102793|NCT05796245|141714234|OTHER|Estimation|Risk Ratio (RR)|2.66|||||TWO_SIDED|95.0|0.37|19.31|||||Crude Risk Ratio Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||19.31|0.37|
71102794|NCT05796245|141714234|OTHER|Estimation|Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.05|0.1|||||Crude Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||0.10|-0.05|
71102795|NCT05796245|141714235|OTHER|Estimation|Cox Proportional Hazard|0.18|||||TWO_SIDED|95.0|0.02|1.85|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||1.85|0.02|
71102796|NCT05796245|141714235|OTHER|Estimation|Risk Ratio (RR)|0.19|||||TWO_SIDED|95.0|0.02|1.99|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||1.99|0.02|
70925945|NCT05235750|141345838|OTHER||Mean Difference (Net)|0.2||||0.83|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for RSES.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for RSES.|We analyzed short- (at 6 weeks post-baseline or T3) and longer-term differences (at 8 weeks post-baseline or T4) for the RSES, expecting a larger size of differences at T3. The short-term difference \[(T3-T2)-(T2-T1)\] represents differences between post-intervention change (T3-T2) and pre-intervention change (T2-T1). Longer-term difference \[(T4-T2)-(T2-T1)\] represents differences between 2 weeks post-intervention change (T4-T2) and pre-intervention change (T2-T1).||||.83
71102797|NCT05796245|141714235|OTHER|Estimation|Risk Difference (RD)|-0.01|||||TWO_SIDED|95.0|-0.17|0.0|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||0.00|-0.17|
71102798|NCT05796245|141714235|OTHER|Estimation|Cox Proportional Hazard|0.63|||||TWO_SIDED|95.0|0.07|6.0|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||6.00|0.07|
71102799|NCT05796245|141714235|OTHER|Estimation|Risk Ratio (RR)|0.71|||||TWO_SIDED|95.0|0.08|6.61|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||6.61|0.08|
71102800|NCT05796245|141714235|OTHER|Estimation|Risk Difference (RD)|-0.01|||||TWO_SIDED|95.0|-0.1|0.21|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||0.21|-0.10|
71102801|NCT05796245|141714235|OTHER|Estimation|Cox Proportional Hazard|2.07|||||TWO_SIDED|95.0|0.28|15.22|||||Crude Hazard Ratio Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||15.22|0.28|
71102802|NCT05796245|141714235|OTHER|Estimation|Risk Ratio (RR)|2.1|||||TWO_SIDED|95.0|0.29|15.08|||||Crude Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||15.08|0.29|
71102803|NCT05796245|141714235|OTHER|Estimation|Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.05|0.09|||||Crude Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||0.09|-0.05|
71102804|NCT04999267|141714236|OTHER|Pre-intervention vs. Post-intervention analysis|||||<|0.0001|||||||Chi-squared|||||||<0.0001
71045677|NCT02697773|141599477|SUPERIORITY|The two comparisons for 'Participants with \>=50% reduction from baseline in WOMAC Pain at Week 16' (tanezumab 2.5 mg treatment group versus placebo and tanezumab 2.5/5 mg treatment group versus placebo) were adjusted for multiple comparisons using the Hochberg procedure and an overall significance level of 0.05.|Odds Ratio (OR)|1.89||||0.001|TWO_SIDED|95.0|1.29|2.76|||Regression, Logistic|||Week 16 \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.76|1.29|0.0010
71102805|NCT04999267|141714237|OTHER|Pre-intervention vs. Post-intervention analysis|||||<|0.0001|||||||Chi-squared|||||||<.0001
71102806|NCT03257657|141714284|OTHER|||||||0.1|||||||t-test, 2 sided|||||||0.1
71102807|NCT03257657|141714286|OTHER|||||||0.13|||||||t-test, 2 sided|||||||0.13
71102808|NCT03257657|141714288|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
71102809|NCT02296099|141714292|EQUIVALENCE|The Mann-Whitney U test was utilized.||||||0.014||||||The p-value was not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|There were no adjustments.||The null hypothesis is that there is no difference in the pain scores between the two groups.||||0.014
71102810|NCT00688740|141714322|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.795||||0.0043|TWO_SIDED|95.0|0.679|0.932||Pairwise stratified log-rank test on the number of positive axillary nodes as per randomization|Log Rank|||||0.932|0.679|0.0043
71102811|NCT00688740|141714323|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.742||||0.002|TWO_SIDED|95.0|0.613|0.898||Pairwise stratified log-rank test on the number of positive axillary nodes as per randomization|Log Rank|||||0.898|0.613|0.0020
71102812|NCT00856557|141714326|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is equal distribution of proportion of successful encounters among groups||||0.33
71102813|NCT00856557|141714326|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.724|STANDARD_ERROR_OF_MEAN|0.346||0.036|TWO_SIDED||||||Mixed Models Analysis|||Considering all encounters (n=179) of all physicians for who outcomes were measured (n=111) together, are encounters in which physicians contextualized the plan of care more likely to be associated with target health outcome achievement than encounters in which physicians did not, controlling for clustering of encounters within physicians. (Generalized logistic mixed model, with random intercept for physician)||||.036
71102814|NCT00856557|141714327|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.99
71102815|NCT00856557|141714328|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.39
71102816|NCT01432444|141714329|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value was derived from Exact McNemar test.|McNemar|||Inpatient hospitalization for retrospective period (Months 4-6) and prospective period (Months 4-6) for closed or open unit.||||<.0001
71102817|NCT01432444|141714330|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Derived from T-test of Mean=0.|t-test|Mean duration was derived as the cumulative duration divided by the number of inpatient non-psychiatric hospitalization.||Statistical analyses for Week 4, 12 and 24.||||<.0001
71102818|NCT01432444|141714331|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Derived from T-test of Mean=0.|t-test, 2 sided|Mean duration was derived as the cumulative duration divided by the number of inpatient non-psychiatric hospitalization.||Statistical analyses for Week 4, Week 12 and Week 24.||||<.0001
71102819|NCT01432444|141714332|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Derived from T-test of Mean=0.|t-test, 2 sided|Mean duration was derived as the cumulative duration divided by the number of inpatient non-psychiatric hospitalization.||Statistical analysis for Week 4, 12 and 24.||||<.0001
71102820|NCT01432444|141714333|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Derived from t-test of mean=0.|t-test|||Statistical analysEs for Week 4, 12 and 24.||||<.0001
71102821|NCT02301897|141714335|SUPERIORITY|||||||0.0008|||||||Chi-Square Test|||||||0.0008
71102822|NCT02301897|141714335|SUPERIORITY||||||<|0.001|||||||Chi-Square Test|||||||<0.001
71102823|NCT02301897|141714336|SUPERIORITY|||||||0.0719|||||||Chi-Square Test|||||||0.0719
71102824|NCT02301897|141714336|SUPERIORITY|||||||0.0004|||||||Chi-Square Test|||||||0.0004
71102825|NCT02301897|141714337|SUPERIORITY|||||||0.0167|||||||Wilcoxon Rank-Sum Test|||CFB to Week 18 Course 1||||0.0167
71102826|NCT02301897|141714337|SUPERIORITY|||||||0.1257|||||||Wilcoxon Rank-Sum Test|||CFB to Week 18 Course 1||||0.1257
71102827|NCT02301897|141714337|SUPERIORITY|||||||0.9754|||||||Wilcoxon Rank-Sum Test|||CFB to ODI Course 1||||0.9754
71102828|NCT02301897|141714337|SUPERIORITY|||||||0.7672|||||||Wilcoxon Rank-Sum Test|||CFB to ODI Course 1||||0.7672
71102829|NCT02301897|141714337|SUPERIORITY|||||||0.2232|||||||Wilcoxon Rank-Sum Test|||CFB to Week 18 Course 2||||0.2232
71102830|NCT02301897|141714337|SUPERIORITY|||||||0.4512|||||||Wilcoxon Rank-Sum Test|||CFB to Week 18 Course 2||||0.4512
71102831|NCT02301897|141714337|SUPERIORITY|||||||0.3545|||||||Wilcoxon Rank-Sum Test|||CFB to Course 2 Week 28 FU||||0.3545
71102832|NCT02301897|141714337|SUPERIORITY|||||||0.2482|||||||Wilcoxon Rank-Sum Test|||CFB to Course 2 Week 28 FU||||0.2482
71102833|NCT02301897|141714338|SUPERIORITY|||||||0.0016|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0016
71102834|NCT02301897|141714338|SUPERIORITY|||||||0.0003|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0003
71102835|NCT02301897|141714338|SUPERIORITY|||||||0.6666|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to ODI Course 1||||0.6666
71102836|NCT02301897|141714338|SUPERIORITY|||||||0.3612|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to ODI Course 1||||0.3612
71102837|NCT02301897|141714338|SUPERIORITY|||||||0.0309|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0309
71102838|NCT02301897|141714338|SUPERIORITY|||||||0.0007|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0007
71102839|NCT02301897|141714338|SUPERIORITY|||||||0.0641|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 28 FU||||0.0641
71102840|NCT02301897|141714338|SUPERIORITY|||||||0.3743|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 28 FU||||0.3743
71102841|NCT02301897|141714339|SUPERIORITY|||||||0.0049|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0049
71102842|NCT02301897|141714339|SUPERIORITY|||||||0.0064|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0064
71102843|NCT02301897|141714339|SUPERIORITY|||||||0.5637|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.5637
71102844|NCT02301897|141714339|SUPERIORITY|||||||0.0505|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0505
71102845|NCT02301897|141714339|SUPERIORITY|||||||0.4262|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.4262
71102846|NCT02301897|141714339|SUPERIORITY|||||||0.1419|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.1419
71102847|NCT02301897|141714339|SUPERIORITY|||||||0.4497|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.4497
71102848|NCT02301897|141714339|SUPERIORITY|||||||0.5371|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.5371
71102849|NCT02301897|141714340|SUPERIORITY|||||||0.0069|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0069
71102850|NCT02301897|141714340|SUPERIORITY|||||||0.0059|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0059
71102851|NCT02301897|141714340|SUPERIORITY|||||||0.2117|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.2117
71102852|NCT02301897|141714340|SUPERIORITY|||||||0.0006|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0006
71102853|NCT02301897|141714340|SUPERIORITY|||||||0.0788|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0788
71102854|NCT02301897|141714340|SUPERIORITY|||||||0.008|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0080
71102855|NCT02301897|141714340|SUPERIORITY|||||||0.1516|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.1516
71102856|NCT02301897|141714340|SUPERIORITY|||||||0.0565|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.0565
71102857|NCT02301897|141714341|SUPERIORITY|||||||0.011|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0110
71102858|NCT02301897|141714341|SUPERIORITY|||||||0.0601|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0601
71102859|NCT02301897|141714341|SUPERIORITY|||||||0.2168|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.2168
71102860|NCT02301897|141714341|SUPERIORITY|||||||0.0101|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0101
71102861|NCT02301897|141714341|SUPERIORITY|||||||0.243|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.2430
71102862|NCT02301897|141714341|SUPERIORITY|||||||0.0843|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0843
71102863|NCT02301897|141714341|SUPERIORITY|||||||0.557|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.5570
71102864|NCT02301897|141714341|SUPERIORITY|||||||0.5302|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.5302
71102865|NCT02301897|141714342|SUPERIORITY|||||||0.0504|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0504
71102866|NCT02301897|141714342|SUPERIORITY|||||||0.0151|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0151
71102867|NCT02301897|141714342|SUPERIORITY|||||||0.5932|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.5932
71102868|NCT02301897|141714342|SUPERIORITY|||||||0.0831|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0831
71102869|NCT02301897|141714342|SUPERIORITY|||||||0.1416|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.1416
71102870|NCT02301897|141714342|SUPERIORITY|||||||0.0392|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0392
71102871|NCT02301897|141714342|SUPERIORITY|||||||0.8275|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.8275
71102872|NCT02301897|141714342|SUPERIORITY|||||||0.8733|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.8733
71102873|NCT02301897|141714343|SUPERIORITY|||||||0.0651|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0651
71102874|NCT02301897|141714343|SUPERIORITY|||||||0.0298|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0298
71102875|NCT02301897|141714343|SUPERIORITY|||||||0.4005|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.4005
71102876|NCT02301897|141714343|SUPERIORITY|||||||0.1114|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.1114
71102877|NCT02301897|141714343|SUPERIORITY|||||||0.1318|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.1318
71102878|NCT02301897|141714343|SUPERIORITY|||||||0.0807|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0807
71102879|NCT02301897|141714343|SUPERIORITY|||||||0.4506|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.4506
71102880|NCT02301897|141714343|SUPERIORITY|||||||0.4614|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.4614
71102881|NCT02301897|141714344|SUPERIORITY|||||||0.0653|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0653
71102882|NCT02301897|141714344|SUPERIORITY|||||||0.048|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0480
71102883|NCT02301897|141714344|SUPERIORITY|||||||0.401|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.4010
71102884|NCT02301897|141714344|SUPERIORITY|||||||0.0772|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0772
71102885|NCT02301897|141714344|SUPERIORITY|||||||0.3206|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.3206
71102886|NCT02301897|141714344|SUPERIORITY|||||||0.1605|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.1605
71102887|NCT02301897|141714344|SUPERIORITY|||||||0.557|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.5570
71102888|NCT02301897|141714344|SUPERIORITY|||||||0.3437|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.3437
71102889|NCT02301897|141714345|SUPERIORITY|||||||0.2624|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.2624
71102890|NCT02301897|141714345|SUPERIORITY|||||||0.0688|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0688
71102891|NCT02301897|141714345|SUPERIORITY|||||||0.279|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.2790
71102892|NCT02301897|141714345|SUPERIORITY|||||||0.6541|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.6541
71102893|NCT02301897|141714345|SUPERIORITY|||||||0.8559|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.8559
71102894|NCT02301897|141714345|SUPERIORITY|||||||0.4326|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.4326
71102895|NCT02301897|141714345|SUPERIORITY|||||||0.1052|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.1052
71102896|NCT02301897|141714345|SUPERIORITY|||||||0.9206|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.9206
71102897|NCT02301897|141714346|SUPERIORITY|||||||0.1439|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.1439
71102898|NCT02301897|141714346|SUPERIORITY|||||||0.067|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0670
71102899|NCT02301897|141714346|SUPERIORITY|||||||0.6761|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.6761
71102900|NCT02301897|141714346|SUPERIORITY|||||||0.0639|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0639
71102901|NCT02301897|141714346|SUPERIORITY|||||||0.2218|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.2218
71102902|NCT02301897|141714346|SUPERIORITY|||||||0.4468|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.4468
71102903|NCT02301897|141714346|SUPERIORITY|||||||0.7678|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.7678
71102904|NCT02301897|141714346|SUPERIORITY|||||||0.8922|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.8922
71102905|NCT02301897|141714347|SUPERIORITY|||||||0.1262|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.1262
71102906|NCT02301897|141714347|SUPERIORITY|||||||0.2075|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.2075
71102907|NCT02301897|141714347|SUPERIORITY|||||||0.5904|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.5904
71102908|NCT02301897|141714347|SUPERIORITY|||||||0.243|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.2430
71045678|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|1.53||||0.0411|TWO_SIDED|95.0|1.02|2.31|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.31|1.02|0.0411
71045679|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|1.72||||0.009|TWO_SIDED|95.0|1.14|2.57|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.57|1.14|0.0090
71045680|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|1.6||||0.1149|TWO_SIDED|95.0|0.89|2.86|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.86|0.89|0.1149
71045681|NCT02697773|141599477|SUPERIORITY||Odds Ratio (OR)|1.56||||0.1351|TWO_SIDED|95.0|0.87|2.79|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.79|0.87|0.1351
71045682|NCT02697773|141599477|SUPERIORITY|The two comparisons for 'Participants with ≥50% reduction from baseline in WOMAC Pain at Week 16' (tanezumab 2.5 mg treatment group versus placebo and tanezumab 2.5/5 mg treatment group versus placebo) were adjusted for multiple comparisons using the Hochberg procedure and an overall significance level of 0.05.|Odds Ratio (OR)|2.17|||<|0.0001|TWO_SIDED|95.0|1.48|3.16|||Regression, Logistic|||Week 16 \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.16|1.48|<.0001
71045683|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|2.12||||0.0001|TWO_SIDED|95.0|1.45|3.11|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.11|1.45|0.0001
71045684|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|2.32|||<|0.0001|TWO_SIDED|95.0|1.59|3.4|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.40|1.59|<.0001
71045685|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|1.58||||0.0312|TWO_SIDED|95.0|1.04|2.39|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.39|1.04|0.0312
71102909|NCT02301897|141714347|SUPERIORITY|||||||0.7067|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.7067
71102910|NCT02301897|141714347|SUPERIORITY|||||||0.2725|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.2725
70925946|NCT05235750|141345838|OTHER||Mean Difference (Net)|-0.2||||0.91|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for RSES.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for RSES.|||||.91
71045686|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|2.12||||0.0003|TWO_SIDED|95.0|1.4|3.19|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.19|1.40|0.0003
71102911|NCT02301897|141714347|SUPERIORITY|||||||0.7016|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.7016
71102912|NCT02301897|141714347|SUPERIORITY|||||||0.8751|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.8751
71102913|NCT02301897|141714348|SUPERIORITY|||||||0.0338|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0338
71102914|NCT02301897|141714348|SUPERIORITY|||||||0.0004|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0004
70941321|NCT00985621|141383143|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.49|-0.44|||ANCOVA|||Analysis was performed using analysis of co-variance (ANCOVA) model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.44|-1.49|<0.001
71045687|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|2.44||||0.0005|TWO_SIDED|95.0|1.48|4.01|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.01|1.48|0.0005
71045688|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|2.39||||0.0006|TWO_SIDED|95.0|1.45|3.94|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.94|1.45|0.0006
71045689|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|2.1||||0.0436|TWO_SIDED|95.0|1.02|4.32|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.32|1.02|0.0436
71102915|NCT02301897|141714348|SUPERIORITY|||||||0.0807|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0807
71102916|NCT02301897|141714348|SUPERIORITY|||||||0.0142|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0142
71102917|NCT02301897|141714348|SUPERIORITY|||||||0.0807|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0807
71102918|NCT02301897|141714348|SUPERIORITY|||||||0.0142|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0142
71009163|NCT02380703|141525905|SUPERIORITY||F-statistic|2.43||||0.06|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.06
71009164|NCT02380703|141525906|SUPERIORITY||F-statistic|0.33||||0.8|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.80
71009165|NCT02380703|141525907|SUPERIORITY||F-statistic|0.21||||0.89|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.89
71009166|NCT02380703|141525908|SUPERIORITY||F-statistic|1.48||||0.22|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.22
71009167|NCT02380703|141525909|SUPERIORITY||F-statistic|0.38||||0.77|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.77
71009168|NCT02380703|141525910|SUPERIORITY||F-statistic|0.56||||0.64|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.64
71009169|NCT02988115|141525971|SUPERIORITY||Least squares means difference|-21.41|STANDARD_ERROR_OF_MEAN|1.897|<|0.001|TWO_SIDED|95.0|-25.132|-17.697|||ANCOVA||bempedoic acid (BA) therapy minus placebo|||-17.697|-25.132|<0.001
71009170|NCT02988115|141525972|SUPERIORITY||Least squares means difference|-18.91|STANDARD_ERROR_OF_MEAN|2.063|<|0.001|TWO_SIDED|95.0|-22.951|-14.865|||ANCOVA||BA therapy minus placebo|||-14.865|-22.951|<0.001
71009171|NCT02988115|141525973|SUPERIORITY||Least squares means difference|-17.94|STANDARD_ERROR_OF_MEAN|1.597|<|0.001|TWO_SIDED|95.0|-21.07|-14.811|||ANCOVA||BA therapy minus placebo|non-HDL-C||-14.811|-21.070|<0.001
71009172|NCT02988115|141525973|SUPERIORITY||Least squares means difference|-14.76|STANDARD_ERROR_OF_MEAN|1.287|<|0.001|TWO_SIDED|95.0|-17.283|-12.239|||ANCOVA||BA therapy minus placebo|TC||-12.239|-17.283|<0.001
71009173|NCT02988115|141525973|SUPERIORITY||Least squares means difference|-14.96|STANDARD_ERROR_OF_MEAN|1.581|<|0.001|TWO_SIDED|95.0|-18.062|-11.866|||ANCOVA||BA therapy minus placebo|apoB||-11.866|-18.062|<0.001
71009174|NCT02988115|141525974|SUPERIORITY||Median treatment difference|-24.29|STANDARD_ERROR_OF_MEAN|-24.3|<|0.001|TWO_SIDED|95.0|-35.888|-12.712|||Wilcoxon rank sum test||BA therapy minus placebo|||-12.712|-35.888|<0.001
71009175|NCT03287089|141525990|SUPERIORITY||Odds Ratio (OR)|1.09||||0.84|TWO_SIDED|95.0|0.49|2.43|||Chi-squared|||||2.43|0.49|0.84
71009176|NCT03287089|141525991|SUPERIORITY|||||||0.44|||||||Chi-squared|||||||0.44
71009177|NCT03287089|141525992|SUPERIORITY|||||||0.68|||||||t-test, 1 sided|||||||0.68
71009178|NCT00661362|141525993|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001|TWO_SIDED|95.0|-0.55|-0.29|||ANCOVA|||||-0.29|-0.55|<0.0001
71009179|NCT00661362|141525994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56|STANDARD_ERROR_OF_MEAN|0.149|<|0.0002|TWO_SIDED|95.0|-0.85|-0.26|||ANCOVA|||||-0.26|-0.85|<0.0002
71009180|NCT00661362|141525995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.1|STANDARD_ERROR_OF_MEAN|2.684|<|0.0002|TWO_SIDED|95.0|-15.37|-4.83|||ANCOVA|||||-4.83|-15.37|<0.0002
71009181|NCT00661362|141525996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-155.0|STANDARD_ERROR_OF_MEAN|55.0||0.0052|TWO_SIDED|95.0|-264.0|-47.0|||ANCOVA|||||-47|-264|0.0052
71009182|NCT00661362|141525997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2802.0|STANDARD_ERROR_OF_MEAN|989.8||0.0052|TWO_SIDED|95.0|-4753.0|-852.0|||ANCOVA|||||-852|-4753|0.0052
71009183|NCT00661362|141525998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.1|||<|0.0001|TWO_SIDED|95.0|8.0|24.0|||ANCOVA|||||24.0|8.0|<0.0001
71045690|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|1.76||||0.1348|TWO_SIDED|95.0|0.84|3.69|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.69|0.84|0.1348
71102919|NCT02301897|141714348|SUPERIORITY|||||||0.1859|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Off-drug||||0.1859
71102920|NCT02301897|141714348|SUPERIORITY|||||||0.0896|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Off-drug||||0.0896
71045691|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|2.3|||<|0.0001|TWO_SIDED|95.0|1.58|3.36|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.36|1.58|<.0001
71102921|NCT00023595|141714376|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.12|TWO_SIDED|95.0|0.72|1.04|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||1.04|0.72|0.12
70925947|NCT05235750|141345839|OTHER||Mean Difference (Net)|-2.1||||0.45|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the total FACT-G.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the total FACT-G.|We analyzed short- (at 6 weeks post-baseline, T3) and longer-term differences (at 8 weeks post-baseline, T4) for the FACT-G at scale, factor and item levels expecting a larger size of differences at T3. The short-term difference \[(T3-T2)-(T2-T1)\] represents differences between post-intervention change (T3-T2) and pre-intervention change (T2-T1). Longer-term difference \[(T4-T2)-(T2-T1)\] represents differences between 2 weeks post-intervention change (T4-T2) and pre-intervention change (T2-T1).||||.45
70925948|NCT05235750|141345839|OTHER||Mean Difference (Net)|-3.3||||0.29|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the total FACT-G.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the total FACT-G.|||||.29
70925949|NCT05235750|141345839|OTHER||Mean Difference (Net)|0.8||||0.46|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for physical well-being (PWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for physical well-being (PWB) as measured by the FACT-G.|||||.46
70925950|NCT05235750|141345839|OTHER||Mean Difference (Net)|0.2||||0.79|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for physical well-being (PWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for physical well-being (PWB) as measured by the FACT-G.|||||.79
70925951|NCT05235750|141345839|OTHER||Mean Difference (Net)|-2.1||||0.05|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for social/family well-being (SWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for social/family well-being (SWB) as measured by the FACT-G.|||||.05
70925952|NCT05235750|141345839|OTHER||Mean Difference (Net)|-2.4||||0.03|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for social/family well-being (SWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for social/family well-being (SWB) as measured by the FACT-G.|||||.03
70925953|NCT05235750|141345839|OTHER||Mean Difference (Net)|-0.2||||0.82|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for emotional well-being (EWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for emotional well-being (EWB) as measured by the FACT-G.|||||.82
70925954|NCT05235750|141345839|OTHER||Mean Difference (Net)|-0.5||||0.58|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for emotional well-being (EWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for emotional well-being (EWB) as measured by the FACT-G.|||||.58
70925955|NCT05235750|141345839|OTHER||Mean Difference (Net)|-0.8||||0.56|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for functional well-being (FWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for functional well-being (FWB) as measured by the FACT-G.|||||.56
70925956|NCT05235750|141345839|OTHER||Mean Difference (Net)|-0.7||||0.58|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for functional well-being (FWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for functional well-being (FWB) as measured by the FACT-G.|||||.58
70925957|NCT05235750|141345839|OTHER||Mean Difference (Net)|-0.2||||0.58|TWO_SIDED|||||"The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for Global QoL (item G7 I am content with the quality of my life right now) as measured by the FACT-G."|Mixed Models Analysis||"The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for Global QoL (item G7 I am content with the quality of my life right now) as measured by the FACT-G."|||||.58
70925958|NCT05235750|141345839|OTHER||Mean Difference (Net)|-0.3||||0.34|TWO_SIDED|||||"The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\] for Global QoL (item G7 I am content with the quality of my life right now) as measured by the FACT-G."|Mixed Models Analysis||"The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for Global QoL (item G7 I am content with the quality of my life right now) as measured by the FACT-G."|||||.34
71102922|NCT00023595|141714377|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.02|TWO_SIDED|95.0|0.73|0.97|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.97|0.73|0.02
71102923|NCT00023595|141714378|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99||||0.9|TWO_SIDED|95.0|0.84|1.17|||Log Rank||Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)|||1.17|0.84|0.90
71102924|NCT00023595|141714379|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio, log|0.79||||0.006|TWO_SIDED|95.0|0.66|0.93|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.93|0.66|0.006
71102925|NCT00023595|141714380|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81||||0.05|TWO_SIDED|95.0|0.66|1.0|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||1.00|0.66|0.05
71045692|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|2.12|||<|0.0001|TWO_SIDED|95.0|1.46|3.09|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.09|1.46|<.0001
71045693|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|2.41|||<|0.0001|TWO_SIDED|95.0|1.62|3.57|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.57|1.62|<.0001
71045694|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|2.57|||<|0.0001|TWO_SIDED|95.0|1.74|3.82|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.82|1.74|<.0001
71045695|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0003|TWO_SIDED|95.0|1.47|3.7|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.70|1.47|0.0003
71045696|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|2.45||||0.0001|TWO_SIDED|95.0|1.55|3.89|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.89|1.55|0.0001
71045697|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|2.02||||0.031|TWO_SIDED|95.0|1.07|3.82|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.82|1.07|0.0310
71045698|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|2.31||||0.0088|TWO_SIDED|95.0|1.24|4.34|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.34|1.24|0.0088
71045699|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|1.49||||0.036|TWO_SIDED|95.0|1.03|2.16|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.16|1.03|0.0360
71045700|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|1.73||||0.0039|TWO_SIDED|95.0|1.19|2.51|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.51|1.19|0.0039
71045701|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|2.12||||0.0002|TWO_SIDED|95.0|1.43|3.13|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.13|1.43|0.0002
71045702|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|1.77||||0.004|TWO_SIDED|95.0|1.2|2.62|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.62|1.20|0.0040
71045703|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0175|TWO_SIDED|95.0|1.1|2.74|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.74|1.10|0.0175
71045704|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|1.87||||0.0065|TWO_SIDED|95.0|1.19|2.94|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.94|1.19|0.0065
71045705|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0796|TWO_SIDED|95.0|0.94|3.23|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.23|0.94|0.0796
71045706|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0718|TWO_SIDED|95.0|0.95|3.27|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.27|0.95|0.0718
71045707|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|2.01||||0.0004|TWO_SIDED|95.0|1.36|2.96|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.96|1.36|0.0004
71045708|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|2.64|||<|0.0001|TWO_SIDED|95.0|1.78|3.93|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.93|1.78|<.0001
71045709|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|2.11||||0.0001|TWO_SIDED|95.0|1.44|3.09|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.09|1.44|0.0001
71045710|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|2.08||||0.0002|TWO_SIDED|95.0|1.42|3.04|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.04|1.42|0.0002
71045711|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|2.13||||0.0003|TWO_SIDED|95.0|1.41|3.23|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.23|1.41|0.0003
71045712|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|2.29|||<|0.0001|TWO_SIDED|95.0|1.52|3.46|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.46|1.52|<.0001
71045713|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|2.09||||0.0113|TWO_SIDED|95.0|1.18|3.68|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.68|1.18|0.0113
71045714|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|2.19||||0.0064|TWO_SIDED|95.0|1.25|3.85|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.85|1.25|0.0064
71045715|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|1.58||||0.02|TWO_SIDED|95.0|1.07|2.31|||Regression, Logistic|||Week 16 \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.31|1.07|0.0200
71045716|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|2.12||||0.0002|TWO_SIDED|95.0|1.43|3.14|||Regression, Logistic|||Week 16 \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.14|1.43|0.0002
71045717|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|1.96||||0.0005|TWO_SIDED|95.0|1.34|2.87|||Regression, Logistic|||Week 16 \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.87|1.34|0.0005
71045718|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|1.69||||0.0141|TWO_SIDED|95.0|1.11|2.56|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.56|1.11|0.0141
71045719|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0022|TWO_SIDED|95.0|1.26|2.87|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.87|1.26|0.0022
71045720|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|1.42||||0.2286|TWO_SIDED|95.0|0.8|2.5|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.50|0.80|0.2286
71045721|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|1.47||||0.1808|TWO_SIDED|95.0|0.84|2.57|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.57|0.84|0.1808
71045722|NCT02697773|141599479|SUPERIORITY||Odds Ratio (OR)|2.3|||<|0.0001|TWO_SIDED|95.0|1.57|3.36|||Regression, Logistic|||Week 16, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.36|1.57|<.0001
71045723|NCT02697773|141599481|SUPERIORITY||Odds Ratio (OR)|1.44||||0.1463|TWO_SIDED|95.0|0.88|2.34|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.34|0.88|0.1463
71045724|NCT02697773|141599481|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9644|TWO_SIDED|95.0|0.6|1.62|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.62|0.60|0.9644
71102926|NCT00023595|141714381|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74|||<|0.001|TWO_SIDED|95.0|0.64|0.85|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.85|0.64|<0.001
71045725|NCT02697773|141599481|SUPERIORITY||Odds Ratio (OR)|1.62||||0.0422|TWO_SIDED|95.0|1.02|2.59|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.59|1.02|0.0422
71102927|NCT00023595|141714382|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72|||<|0.001|TWO_SIDED|95.0|0.64|0.82|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.82|0.64|<0.001
71102928|NCT00023595|141714383|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.79|1.26|||Log Rank||Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)|||1.26|0.79|0.98
71102929|NCT00023595|141714384|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.19||||0.008|TWO_SIDED|95.0|1.35|7.52|||Regression, Logistic||Odds Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||7.52|1.35|0.008
71102930|NCT00023595|141714385|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.275|TWO_SIDED|95.0|0.78|2.41|||Regression, Logistic||Odds Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)|||2.41|0.78|0.275
71102931|NCT00023595|141714386|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.03|TWO_SIDED|95.0|0.71|0.98|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.98|0.71|0.030
71102932|NCT00023595|141714387|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.08||||0.401|TWO_SIDED|95.0|0.89|1.31|||Log Rank||Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)|||1.31|0.89|0.401
71102933|NCT00023595|141714388|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81||||0.002|TWO_SIDED|95.0|0.71|0.93|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.93|0.71|0.002
71102934|NCT00023595|141714404|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||<|0.001|TWO_SIDED|95.0|0.51|0.71|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.71|0.51|<0.001
71102935|NCT00023595|141714405|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.414|TWO_SIDED|95.0|0.73|1.13|||Log Rank||Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)|||1.13|0.73|0.414
71102936|NCT00023595|141714406|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||<|0.001|TWO_SIDED|95.0|0.55|0.73|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.73|0.55|<0.001
71102937|NCT00023595|141714407|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.108|TWO_SIDED|95.0|0.72|1.03|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||1.03|0.72|0.108
71102938|NCT00023595|141714408|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.05||||0.717|TWO_SIDED|95.0|0.83|1.32|||Log Rank||Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)|||1.32|0.83|0.717
71102939|NCT00023595|141714409|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.018|TWO_SIDED|95.0|0.73|0.97|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.97|0.73|0.018
71102940|NCT00023595|141714425|SUPERIORITY|||||||0.015||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.015
71102941|NCT00023595|141714425|SUPERIORITY|||||||0.002||||||12 months|Chi-squared|||||||0.002
71102942|NCT00023595|141714425|SUPERIORITY|||||||0.011||||||24 months|Chi-squared|||||||0.011
71102943|NCT00023595|141714425|SUPERIORITY|||||||0.44||||||36 months|Chi-squared|||||||0.44
71102944|NCT00023595|141714426|SUPERIORITY|||||||0.91||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.91
71102945|NCT00023595|141714426|SUPERIORITY|||||||0.62||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.62
71102946|NCT00023595|141714426|SUPERIORITY|||||||0.04||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.04
71102947|NCT00023595|141714426|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
71102948|NCT00023595|141714426|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
71102949|NCT00023595|141714427|SUPERIORITY|||||||0.31||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.31
71102950|NCT00023595|141714427|SUPERIORITY|||||||0.002||||||12 months|Chi-squared|||||||0.002
71102951|NCT00023595|141714427|SUPERIORITY|24 months||||||0.028|||||||Chi-squared|||||||0.028
71102952|NCT00023595|141714427|SUPERIORITY|||||||0.079||||||36 months|Chi-squared|||||||0.079
71102953|NCT00023595|141714428|SUPERIORITY|||||||0.74||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.74
71102954|NCT00023595|141714428|SUPERIORITY|||||||0.61||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.61
71102955|NCT00023595|141714428|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
71102956|NCT00023595|141714428|SUPERIORITY|||||||0.94||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.94
71102957|NCT00023595|141714428|SUPERIORITY|||||||0.29||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.29
71102958|NCT00023595|141714429|SUPERIORITY|||||||0.063||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.063
71102959|NCT00023595|141714429|SUPERIORITY|||||||0.187||||||12 months|Chi-squared|||||||0.187
71102960|NCT00023595|141714429|SUPERIORITY|||||||0.168||||||24 months|Chi-squared|||||||0.168
71102961|NCT00023595|141714429|SUPERIORITY|||||||0.05||||||36 months|Chi-squared|||||||0.050
71102962|NCT00023595|141714430|SUPERIORITY|||||||0.82||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.82
71102963|NCT00023595|141714430|SUPERIORITY|||||||0.48||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.48
71102964|NCT00023595|141714430|SUPERIORITY|||||||0.69||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.69
71102965|NCT00023595|141714430|SUPERIORITY|||||||0.63||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.63
71102966|NCT00023595|141714430|SUPERIORITY|||||||0.9||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.90
71102967|NCT00023595|141714431|SUPERIORITY|||||||0.039||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.039
71009184|NCT04880642|141526009|SUPERIORITY|"The null hypothesis was that the there was no difference in survival up to Day 60 between the two groups and was to be rejected in favour of the alternative hypothesis i.e. a difference in survival up to Day 60 between the two groups excisted.~The overall 2-sided significance level of 5% was applied to the primary endpoint."|Hazard Ratio (HR)|0.98||||0.949|TWO_SIDED|95.0|0.4|2.36|||Log Rank|||||2.36|0.40|0.949
71009185|NCT04880642|141526010|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.301|TWO_SIDED|95.0|0.91|1.52|||Log Rank|||||1.52|0.91|0.301
71009186|NCT04880642|141526011|SUPERIORITY||Median Difference (Final Values)|0.0||||0.425|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||||1|-1|0.425
71009187|NCT04880642|141526012|SUPERIORITY||Risk Difference (RD)|-1.7|STANDARD_ERROR_OF_MEAN|3.91||0.671|TWO_SIDED|95.0|-9.3|6.0|||Regression, Logistic|||||6.0|-9.3|0.671
71009188|NCT04880642|141526013|SUPERIORITY||Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|5.62||0.948|TWO_SIDED|95.0|-11.4|10.6|||Regression, Logistic|||||10.6|-11.4|0.948
71009189|NCT03123549|141526094|SUPERIORITY|||||||0.017|||||||t-test, 1 sided|||||||0.017
71045726|NCT02697773|141599481|SUPERIORITY||Odds Ratio (OR)|1.36||||0.1995|TWO_SIDED|95.0|0.85|2.16|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.16|0.85|0.1995
71045727|NCT02697773|141599481|SUPERIORITY||Odds Ratio (OR)|1.17||||0.4878|TWO_SIDED|95.0|0.75|1.84|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.84|0.75|0.4878
71045728|NCT02697773|141599481|SUPERIORITY||Odds Ratio (OR)|1.06||||0.7856|TWO_SIDED|95.0|0.68|1.67|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.67|0.68|0.7856
71009190|NCT03742271|141526145|SUPERIORITY|Superiority was concluded in the lower limit of the 95% confidence interval was above 0.50.|Proportion|0.974|||||TWO_SIDED|95.0|0.925|0.995|||Binomial Exact Test|||This study was powered to test the hypothesis that at least 50% will have an acceptable lens fitting.||0.995|0.925|
71009191|NCT01624974|141526148|SUPERIORITY||Difference in Least Squares (LS) Means|0.047||||0.282|TWO_SIDED|95.0|-0.039|0.134|||LDA model|The LDA model assumes that repeated measurements follow a multivariate normal distribution.||||0.134|-0.039|0.282
71009192|NCT02430389|141526174|SUPERIORITY_OR_OTHER|||||||0.0575|TWO_SIDED||||||t-test, 2 sided|||||||.0575
71009193|NCT02430389|141526175|SUPERIORITY_OR_OTHER|||||||0.348|TWO_SIDED||||||t-test, 2 sided|||||||.348
71009194|NCT01468844|141526176|OTHER|The mean difference between the minocycline and placebo arms in change in BCVA in the study eye at Month 12 compared to baseline is reported.|Mean Difference (Net)|15.3|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71045729|NCT02697773|141599481|SUPERIORITY||Odds Ratio (OR)|1.55||||0.0476|TWO_SIDED|95.0|1.0|2.39|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.39|1.00|0.0476
71045730|NCT02697773|141599481|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0124|TWO_SIDED|95.0|1.12|2.63|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.63|1.12|0.0124
71009195|NCT01468844|141526177|OTHER|The difference between the minocycline and placebo treatment arms in number of participants improving ≥ 1 logOCT scale step in the study eye at Month 12 compared to baseline is reported.|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71009196|NCT01468844|141526178|OTHER|The difference between the minocycline and placebo treatment arms in number of participants improving ≥ 1 logOCT scale step in the study eye at Month 24 compared to baseline is reported|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71009197|NCT01468844|141526179|OTHER|The mean difference between the minocycline and placebo treatment arms in number of bevacizumab injections received from baseline to Month 12 is reported.|Mean Difference (Net)|-5.0|STANDARD_DEVIATION|2.3|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71045731|NCT02697773|141599481|SUPERIORITY||Odds Ratio (OR)|1.66||||0.0307|TWO_SIDED|95.0|1.05|2.62|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.62|1.05|0.0307
71009198|NCT01468844|141526180|OTHER|The mean difference between the minocycline and placebo treatment arms in number of bevacizumab injections received from baseline to Month 24 is reported.|Mean Difference (Net)|-8.2|STANDARD_DEVIATION|4.4|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71009199|NCT01468844|141526181|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 3 compared to baseline is reported.|Mean Difference (Net)|-2.5|STANDARD_DEVIATION|1.3|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71009200|NCT01468844|141526182|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 6 compared to baseline is reported.|Mean Difference (Net)|-0.8|STANDARD_DEVIATION|3.5|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71009201|NCT01468844|141526183|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 12 compared to baseline is reported.|Mean Difference (Net)|-3.0|STANDARD_DEVIATION|3.2|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71009202|NCT01468844|141526184|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 18 compared to baseline is reported.|Mean Difference (Net)|-5.4|STANDARD_DEVIATION|2.8|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71009203|NCT01468844|141526185|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 24 compared to baseline is reported.|Mean Difference (Net)|-5.4|STANDARD_DEVIATION|3.8|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71102968|NCT00023595|141714431|SUPERIORITY|||||||0.002||||||12 months|Chi-squared|||||||0.002
71102969|NCT00023595|141714431|SUPERIORITY|||||||0.008||||||24 months|Chi-squared|||||||0.008
71102970|NCT00023595|141714431|SUPERIORITY|||||||0.31||||||36 months|Chi-squared|||||||0.31
71102971|NCT00023595|141714432|SUPERIORITY|||||||0.36||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.36
71102972|NCT00023595|141714432|SUPERIORITY|||||||0.87||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.87
71102973|NCT00023595|141714432|SUPERIORITY|||||||0.17||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.17
71102974|NCT00023595|141714432|SUPERIORITY|||||||0.12||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.12
71102975|NCT00023595|141714432|SUPERIORITY|||||||0.79||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.79
71102976|NCT00023595|141714433|SUPERIORITY||||||<|0.001||||||4 months|Chi-squared|||||||<0.001
71102977|NCT00023595|141714433|SUPERIORITY||||||<|0.001||||||12 months|Chi-squared|||||||<0.001
71102978|NCT00023595|141714433|SUPERIORITY||||||<|0.001||||||24 months|Chi-squared|||||||<0.001
71102979|NCT00023595|141714433|SUPERIORITY||||||<|0.024||||||36 months|Chi-squared|||||||<0.024
71102980|NCT00023595|141714434|SUPERIORITY|||||||0.31||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.31
71102981|NCT00023595|141714434|SUPERIORITY|||||||0.42||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.42
71102982|NCT00023595|141714434|SUPERIORITY|||||||0.66||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.66
71102983|NCT00023595|141714434|SUPERIORITY|||||||0.32||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.32
71102984|NCT00023595|141714434|SUPERIORITY|||||||0.43||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.43
71102985|NCT00023595|141714435|SUPERIORITY|||||||0.051||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.051
71102986|NCT00023595|141714435|SUPERIORITY|||||||0.003||||||12 months|Chi-squared|||||||0.003
71102987|NCT00023595|141714435|SUPERIORITY|||||||0.065||||||24 months|Chi-squared|||||||0.065
70941322|NCT00985621|141383143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.5|-0.43|||ANCOVA|||Analysis was performed using analysis of co-variance (ANCOVA) model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.43|-1.50|<0.001
71102988|NCT00023595|141714435|SUPERIORITY|||||||0.83||||||36 months|Chi-squared|||||||0.83
71102989|NCT00023595|141714436|SUPERIORITY|||||||0.71||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.71
71102990|NCT00023595|141714436|SUPERIORITY|||||||0.57||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.57
71102991|NCT00023595|141714436|SUPERIORITY|||||||0.15||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.15
71102992|NCT00023595|141714436|SUPERIORITY|||||||0.64||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.64
71102993|NCT00023595|141714436|SUPERIORITY|||||||0.07||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.07
71102994|NCT00023595|141714437|SUPERIORITY|||||||0.004||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.004
71102995|NCT00023595|141714437|SUPERIORITY|||||||0.011||||||12 months|Chi-squared|||||||0.011
71102996|NCT00023595|141714437|SUPERIORITY|||||||0.007||||||24 months|Chi-squared|||||||0.007
71102997|NCT00023595|141714437|SUPERIORITY|||||||0.044||||||36 months|Chi-squared|||||||0.044
71102998|NCT00023595|141714438|SUPERIORITY|||||||0.74||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.74
71102999|NCT00023595|141714438|SUPERIORITY|||||||0.87||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.87
71103000|NCT00023595|141714438|SUPERIORITY|||||||0.03||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.03
71103001|NCT00023595|141714438|SUPERIORITY|||||||0.6||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.60
71103002|NCT00023595|141714438|SUPERIORITY|||||||0.87||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.87
71103003|NCT00023595|141714439|SUPERIORITY|||||||0.05||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.050
71103004|NCT00023595|141714439|SUPERIORITY|||||||0.003||||||12 months|Chi-squared|||||||0.003
71103005|NCT00023595|141714439|SUPERIORITY|24 months||||||0.049|||||||Chi-squared|||||||0.049
71103006|NCT00023595|141714439|SUPERIORITY|||||||0.097||||||36 months|Chi-squared|||||||0.097
71103007|NCT00023595|141714440|SUPERIORITY|||||||0.4||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.40
71103008|NCT00023595|141714440|SUPERIORITY|||||||0.13||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.13
71103009|NCT00023595|141714440|SUPERIORITY|||||||0.86||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.86
71103010|NCT00023595|141714440|SUPERIORITY|||||||0.89||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.89
71103011|NCT00023595|141714440|SUPERIORITY|||||||0.87||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.87
71103012|NCT00023595|141714441|SUPERIORITY|||||||0.005||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.005
71103013|NCT00023595|141714441|SUPERIORITY|||||||0.023||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.023
71103014|NCT00023595|141714441|SUPERIORITY|||||||0.009||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.009
71103015|NCT00023595|141714441|SUPERIORITY|||||||0.26||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.26
71103016|NCT00023595|141714442|SUPERIORITY|||||||0.38||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.38
71103017|NCT00023595|141714442|SUPERIORITY|||||||0.45||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.45
71103018|NCT00023595|141714442|SUPERIORITY|||||||0.62||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.62
71103019|NCT00023595|141714442|SUPERIORITY|||||||0.82||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.82
71103020|NCT00023595|141714442|SUPERIORITY|||||||0.94||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.94
71103021|NCT00023595|141714443|SUPERIORITY|||||||0.205||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.205
71103022|NCT00023595|141714443|SUPERIORITY|||||||0.017||||||12 months|Chi-squared|||||||0.017
71103023|NCT00023595|141714443|SUPERIORITY|||||||0.028||||||24 months|Chi-squared|||||||0.028
71103024|NCT00023595|141714443|SUPERIORITY|||||||0.123||||||36 months|Chi-squared|||||||0.123
71009204|NCT01468844|141526186|OTHER|The mean difference between the minocycline and placebo arms in change in BCVA in the study eye at Month 24 compared to baseline is reported.|Mean Difference (Net)|30.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71009205|NCT01468844|141526187|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 6 compared to baseline is reported.|Mean Difference (Net)|39.3|STANDARD_DEVIATION|113.3|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71009206|NCT01468844|141526188|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 12 compared to baseline is reported.|Mean Difference (Net)|313.2|STANDARD_DEVIATION|267.3|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71009207|NCT01468844|141526189|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 18 compared to baseline is reported.|Mean Difference (Net)|428.5|STANDARD_DEVIATION|146.2|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71009208|NCT01468844|141526190|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 24 compared to baseline is reported.|Mean Difference (Net)|119.0|STANDARD_DEVIATION|66.6|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71009209|NCT01468844|141526191|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing a decrease in fluid leakage at Month 12 compared to baseline is reported.|Difference in Number of Participants|1.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71009210|NCT01468844|141526191|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing an increase in fluid leakage at Month 12 compared to baseline is reported.|Difference in Number of Participants|-1.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71009211|NCT01468844|141526191|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing no change in fluid leakage at Month 12 compared to baseline is reported.|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71009212|NCT01468844|141526192|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing a decrease in fluid leakage at Month 24 compared to baseline is reported.|Difference in Number of Participants|1.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71045732|NCT02697773|141599481|SUPERIORITY||Odds Ratio (OR)|1.49||||0.0846|TWO_SIDED|95.0|0.95|2.35|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.35|0.95|0.0846
71103025|NCT00023595|141714444|SUPERIORITY|||||||0.19||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.19
71009213|NCT01468844|141526192|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing an increase in fluid leakage at Month 24 compared to baseline is reported.|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71009214|NCT01468844|141526192|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing no change in fluid leakage at Month 24 compared to baseline is reported.|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71009215|NCT02417935|141526206|NON_INFERIORITY|If the upper bound of the 95% CI does not exceed 0.51 (pre-defined non-inferiority margin), it will be concluded that duloxetine is not inferior to Pregabalin.|Mean Difference (Final Values)|0.072||||0.7|TWO_SIDED|95.0|-0.295|0.439|||Mixed Models Analysis|||||0.439|-0.295|0.700
71009216|NCT02417935|141526207|OTHER||Mean Difference (Final Values)|-0.2||||0.149|TWO_SIDED|95.0|-0.4|0.1|||Mixed Models Analysis|||||0.1|-0.4|0.149
71009217|NCT02417935|141526208|OTHER||Mean Difference (Final Values)|0.1||||0.535|TWO_SIDED|95.0|-0.3|0.6|||Mixed Models Analysis|||Worst Pain||0.6|-0.3|.535
71009218|NCT02417935|141526208|OTHER||Mean Difference (Final Values)|-0.1||||0.436|TWO_SIDED|95.0|-0.5|0.2|||Mixed Models Analysis|||Least Pain||0.2|-0.5|.436
71009219|NCT02417935|141526208|OTHER||Mean Difference (Final Values)|0.1||||0.534|TWO_SIDED|95.0|-0.2|0.5|||Mixed Models Analysis|||Average Pain||0.5|-0.2|.534
71009220|NCT02417935|141526208|OTHER||Mean Difference (Final Values)|0.0||||0.948|TWO_SIDED|95.0|-0.4|0.4|||Mixed Models Analysis|||Pain Right Now||0.4|-0.4|.948
71009221|NCT02417935|141526208|OTHER||Mean Difference (Final Values)|-0.2||||0.225|TWO_SIDED|95.0|-0.6|0.1|||Mixed Models Analysis|||General Activity||0.1|-0.6|.225
71009222|NCT02417935|141526208|OTHER||Mean Difference (Final Values)|-0.2||||0.276|TWO_SIDED|95.0|-0.6|0.2|||Mixed Models Analysis|||Mood||0.2|-0.6|.276
71009223|NCT02417935|141526208|OTHER||Mean Difference (Final Values)|-0.1||||0.507|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|||Walking Ability||0.2|-0.4|.507
71009224|NCT02417935|141526208|OTHER||Mean Difference (Final Values)|-0.2||||0.216|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|||Normal Work||0.1|-0.5|.216
71009225|NCT02417935|141526208|OTHER||Mean Difference (Final Values)|-0.2||||0.233|TWO_SIDED|95.0|-0.4|0.1|||Mixed Models Analysis|||Relations with other people||0.1|-0.4|.233
71009226|NCT02417935|141526208|OTHER||Mean Difference (Final Values)|0.0||||0.857|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|||Sleep||0.3|-0.3|.857
71009227|NCT02417935|141526208|OTHER||Mean Difference (Final Values)|-0.2||||0.133|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|||Enjoyment of life||0.1|-0.5|.133
71009228|NCT02417935|141526208|OTHER||Mean Difference (Final Values)|-0.16||||0.246|TWO_SIDED|95.0|-0.44|0.11|||Mixed Models Analysis|||Average Interference Score||0.11|-0.44|.246
71009229|NCT02417935|141526209|OTHER||Mean Difference (Final Values)|-0.7||||0.627|TWO_SIDED|95.0|-3.6|2.2|||ANCOVA|||Total Score||2.2|-3.6|.627
71103026|NCT00023595|141714444|SUPERIORITY|||||||0.07||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.07
71103027|NCT00023595|141714444|SUPERIORITY|||||||0.94||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.94
71103028|NCT00023595|141714444|SUPERIORITY|||||||0.67||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.67
71103029|NCT00023595|141714444|SUPERIORITY|||||||0.44||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.44
71103030|NCT00023595|141714445|SUPERIORITY|||||||0.05||||||4 months|Chi-squared|P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.050
71103031|NCT00023595|141714445|SUPERIORITY|||||||0.006||||||12 months|Chi-squared|||||||0.006
71103032|NCT00023595|141714445|SUPERIORITY|||||||0.039||||||24 months|Chi-squared|||||||0.039
71103033|NCT00023595|141714445|SUPERIORITY|||||||0.074||||||36 months|Chi-squared|||||||0.074
71103034|NCT00023595|141714446|SUPERIORITY|||||||0.23||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.23
71103035|NCT00023595|141714446|SUPERIORITY|||||||0.43||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.43
71103036|NCT00023595|141714446|SUPERIORITY|||||||0.35||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.35
71103037|NCT00023595|141714446|SUPERIORITY|||||||0.9||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.90
71103038|NCT00023595|141714446|SUPERIORITY|||||||0.48||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.48
71103039|NCT00023595|141714447|SUPERIORITY|||||||0.085||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.085
70925959|NCT05235750|141345839|OTHER||Mean Difference (Net)|0.4||||0.27|TWO_SIDED|||||"The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for item Ge6 I worry that my condition will get worse as measured by the FACT-G."|Mixed Models Analysis||"The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for item Ge6 I worry that my condition will get worse as measured by the FACT-G."|||||.27
71103040|NCT00023595|141714447|SUPERIORITY|||||||0.007|||||||Chi-squared|||||||0.007
71103041|NCT00023595|141714447|SUPERIORITY|||||||0.026||||||24 months|Chi-squared|||||||0.026
71103042|NCT00023595|141714447|SUPERIORITY|||||||0.085||||||36 months|Chi-squared|||||||0.085
71103043|NCT00023595|141714448|SUPERIORITY|||||||0.18||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.18
71103044|NCT00023595|141714448|SUPERIORITY|||||||0.17||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.17
71103045|NCT00023595|141714448|SUPERIORITY|||||||0.59||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.59
71103046|NCT00023595|141714448|SUPERIORITY|||||||0.78||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.78
71103047|NCT00023595|141714448|SUPERIORITY|||||||0.48||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.48
71103048|NCT00023595|141714449|SUPERIORITY||||||<|0.001||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||<0.001
71103049|NCT00023595|141714449|SUPERIORITY||||||<|0.001||||||12 month|Chi-squared|||||||<0.001
71103050|NCT00023595|141714449|SUPERIORITY||||||<|0.001||||||24 months|Chi-squared|||||||<0.001
71103051|NCT00023595|141714449|SUPERIORITY|||||||0.018||||||36 months|Chi-squared|||||||0.018
71103052|NCT00023595|141714450|SUPERIORITY|||||||0.7||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.70
71103053|NCT00023595|141714450|SUPERIORITY|||||||0.47||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.47
71103054|NCT00023595|141714450|SUPERIORITY|||||||0.87||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.87
71103055|NCT00023595|141714450|SUPERIORITY|||||||0.84||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.84
71103056|NCT00023595|141714450|SUPERIORITY|||||||0.82||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.82
71103057|NCT00023595|141714451|SUPERIORITY|||||||0.023||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.023
71103058|NCT00023595|141714451|SUPERIORITY|||||||0.001||||||12 months|Chi-squared|||||||0.001
71103059|NCT00023595|141714451|SUPERIORITY|||||||0.077||||||24 months|Chi-squared|||||||0.077
71103060|NCT00023595|141714451|SUPERIORITY|||||||0.17||||||36 months|Chi-squared|||||||0.170
71103061|NCT00023595|141714452|SUPERIORITY|||||||0.63||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.63
71103062|NCT00023595|141714452|SUPERIORITY|||||||0.29||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.29
71103063|NCT00023595|141714452|SUPERIORITY|||||||0.68||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.68
71103064|NCT00023595|141714452|SUPERIORITY|||||||0.25||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.25
71103065|NCT00023595|141714452|SUPERIORITY|||||||0.68||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.68
71103066|NCT00023595|141714453|SUPERIORITY|||||||0.033||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.033
71103067|NCT00023595|141714453|SUPERIORITY|||||||0.002||||||12 months|Chi-squared|||||||0.002
71103068|NCT00023595|141714453|SUPERIORITY|||||||0.015||||||24 months|Chi-squared|||||||0.015
71103069|NCT00023595|141714453|SUPERIORITY|||||||0.051||||||36 months|Chi-squared|||||||0.051
71103070|NCT00023595|141714454|SUPERIORITY|||||||0.26||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.26
71103071|NCT00023595|141714454|SUPERIORITY|||||||0.23||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.23
71103072|NCT00023595|141714454|SUPERIORITY|||||||0.66||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.66
71103073|NCT00023595|141714454|SUPERIORITY|||||||0.98||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.98
71103074|NCT00023595|141714454|SUPERIORITY|||||||0.86||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.86
71103075|NCT00023595|141714455|SUPERIORITY||||||<|0.001||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||<0.001
71103076|NCT00023595|141714455|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71103077|NCT00023595|141714455|SUPERIORITY|||||||0.006||||||24 months|Chi-squared|||||||0.006
71103078|NCT00023595|141714455|SUPERIORITY|||||||0.037||||||36 months|Chi-squared|||||||0.037
71103079|NCT00023595|141714456|SUPERIORITY|||||||0.53||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.53
71103080|NCT00023595|141714456|SUPERIORITY|||||||0.26||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.26
71103081|NCT00023595|141714456|SUPERIORITY|||||||0.76||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.76
71103082|NCT00023595|141714456|SUPERIORITY|||||||0.89||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.89
71103083|NCT00023595|141714456|SUPERIORITY|||||||0.89||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.89
71103084|NCT00023595|141714457|SUPERIORITY||||||<|0.001||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||<0.001
71103085|NCT00023595|141714457|SUPERIORITY||||||<|0.001||||||12 months|Chi-squared|||||||<0.001
70850346|NCT01247272|141188456|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.99|||||TWO_SIDED|90.0|102.09|112.12|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||112.12|102.09|
71103086|NCT00023595|141714457|SUPERIORITY||||||<|0.001||||||24 months|Chi-squared|||||||<0.001
71103087|NCT00023595|141714457|SUPERIORITY|||||||0.01||||||36 months|Chi-squared|||||||0.010
71103088|NCT00023595|141714458|SUPERIORITY|||||||0.01||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.01
71103089|NCT00023595|141714458|SUPERIORITY|||||||0.74||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.74
71103090|NCT00023595|141714458|SUPERIORITY|||||||0.77||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.77
71103091|NCT00023595|141714458|SUPERIORITY|||||||0.46||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.46
71103092|NCT00023595|141714458|SUPERIORITY|||||||0.27||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.27
71103093|NCT00023595|141714459|SUPERIORITY|||||||0.029||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.029
71103094|NCT00023595|141714459|SUPERIORITY|||||||0.042||||||12 months|Chi-squared|||||||0.042
71103095|NCT00023595|141714459|SUPERIORITY|||||||0.3||||||24 months|Chi-squared|||||||0.30
71103096|NCT00023595|141714459|SUPERIORITY|||||||0.2||||||36 months|Chi-squared|||||||0.20
71103097|NCT00023595|141714460|SUPERIORITY|||||||0.98||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.98
71103098|NCT00023595|141714460|SUPERIORITY|||||||0.16||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.16
71103099|NCT00023595|141714460|SUPERIORITY|||||||0.88||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.88
71103100|NCT00023595|141714460|SUPERIORITY|||||||0.95||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.95
71103101|NCT00023595|141714460|SUPERIORITY|||||||0.48||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.48
71103102|NCT00023595|141714461|SUPERIORITY||||||<|0.001||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||<0.001
71103103|NCT00023595|141714461|SUPERIORITY||||||<|0.001||||||12 months|Chi-squared|||||||<0.001
71103104|NCT00023595|141714461|SUPERIORITY||||||<|0.001||||||24 months|Chi-squared|||||||<0.001
71103105|NCT00023595|141714461|SUPERIORITY|||||||0.001||||||36 months|Chi-squared|||||||0.001
71103106|NCT00023595|141714462|SUPERIORITY|||||||0.86||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.86
71103107|NCT00023595|141714462|SUPERIORITY|||||||0.39||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.39
71103108|NCT00023595|141714462|SUPERIORITY|||||||0.65||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.65
71103109|NCT00023595|141714462|SUPERIORITY|||||||0.15||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.15
71103110|NCT00023595|141714462|SUPERIORITY|||||||0.68||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.68
71103111|NCT00023595|141714463|SUPERIORITY||||||<|0.001||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||<0.001
71103112|NCT00023595|141714463|SUPERIORITY||||||<|0.001||||||12 months|Chi-squared|||||||<0.001
71103113|NCT00023595|141714463|SUPERIORITY|||||||0.001||||||24 months|Chi-squared|||||||0.001
71103114|NCT00023595|141714463|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
71103115|NCT00023595|141714464|SUPERIORITY|||||||0.96||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.96
71103116|NCT00023595|141714464|SUPERIORITY|||||||0.53||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.53
71103117|NCT00023595|141714464|SUPERIORITY|||||||0.37||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.37
71103118|NCT00023595|141714464|SUPERIORITY|||||||0.78||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.78
71103119|NCT00023595|141714464|SUPERIORITY|||||||0.21||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.21
71103120|NCT00023595|141714465|SUPERIORITY|||||||0.007||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.007
71103121|NCT00023595|141714465|SUPERIORITY|||||||0.003||||||12 months|Chi-squared|||||||0.003
71103122|NCT00023595|141714465|SUPERIORITY|||||||0.023||||||24 months|Chi-squared|||||||0.023
71103123|NCT00023595|141714465|SUPERIORITY|||||||0.06||||||36 months|Chi-squared|||||||0.060
71103124|NCT00023595|141714466|SUPERIORITY|||||||0.31||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.31
71103125|NCT00023595|141714466|SUPERIORITY|||||||0.43||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.43
71103126|NCT00023595|141714466|SUPERIORITY|||||||0.57||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.57
71103127|NCT00023595|141714466|SUPERIORITY|||||||0.95||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.95
71103128|NCT00023595|141714466|SUPERIORITY|||||||0.38||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.38
71103129|NCT00023595|141714467|SUPERIORITY|||||||0.86||||||Baseline|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.86
71103130|NCT00023595|141714467|SUPERIORITY|||||||0.78||||||4 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.78
71103131|NCT00023595|141714467|SUPERIORITY|||||||0.55||||||12 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.55
71103132|NCT00023595|141714467|SUPERIORITY|||||||0.027||||||24 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.027
71103133|NCT00023595|141714467|SUPERIORITY|||||||0.031||||||36 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.031
71103134|NCT00023595|141714468|SUPERIORITY|||||||0.4||||||Baseline|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.40
71103135|NCT00023595|141714468|SUPERIORITY|||||||0.42||||||4 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.42
71103136|NCT00023595|141714468|SUPERIORITY|||||||0.41||||||12 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.41
71009230|NCT02417935|141526209|OTHER||Mean Difference (Final Values)|-0.2||||0.355|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Burning Pain||0.2|-0.6|.355
71009231|NCT02417935|141526209|OTHER||Mean Difference (Final Values)|0.1||||0.731|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Pressing Pain||0.4|-0.3|.731
71009232|NCT02417935|141526209|OTHER||Mean Difference (Final Values)|0.1||||0.721|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Paroxysmal Pain||0.4|-0.3|.721
71009233|NCT02417935|141526209|OTHER||Mean Difference (Final Values)|-0.2||||0.345|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Evoked Pain||0.2|-0.5|.345
71009234|NCT02417935|141526209|OTHER||Mean Difference (Final Values)|-0.1||||0.557|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Paresthesia/Dysesthesia||0.3|-0.5|.557
71009235|NCT02417935|141526210|OTHER||Mean Difference (Final Values)|-0.2||||0.106|TWO_SIDED|95.0|-0.4|0.0|||Mixed Models Analysis|||||0.0|-0.4|.106
71009236|NCT02417935|141526211|OTHER||Mean Difference (Final Values)|0.014||||0.361|TWO_SIDED|95.0|-0.0161|0.0441|||ANCOVA|||||0.0441|-0.0161|.361
71009237|NCT02417935|141526212|OTHER||Mean Difference (Final Values)|0.2||||0.701|TWO_SIDED|95.0|-0.8|1.1|||Mixed Models Analysis|||||1.1|-0.8|.701
71009238|NCT02417935|141526213|OTHER||Mean Difference (Final Values)|0.005||||0.976|TWO_SIDED|95.0|-0.355|0.366|||Mixed Models Analysis|||||0.366|-0.355|.976
71103137|NCT00023595|141714468|SUPERIORITY|||||||0.25||||||24 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.25
70850347|NCT01247272|141188457|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.57|||||TWO_SIDED|90.0|99.54|107.76|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||107.76|99.54|
71009239|NCT02417935|141526214|OTHER||Mean Difference (Final Values)|0.136||||0.503|TWO_SIDED|95.0|-0.264|0.537|||Mixed Models Analysis|||||0.537|-0.264|.503
71009240|NCT02417935|141526215|OTHER|||||||0.632||||||30% reduction|Fisher Exact|||||||.632
71009241|NCT02417935|141526215|OTHER|||||||0.907|||||||Fisher Exact|||50% Reduction||||.907
71009242|NCT01899729|141526224|OTHER|Used mixed effects model||||||0.06|||||||Mixed Models Analysis|||||||0.06
71009243|NCT01454531|141526228|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Paired values|t-test, 2 sided|||The null hypothesis is no changes in IgE-blocking factor values from visit 1 (baseline) to visit 6 (end of treatment) versus the alternative hypothesis of change in IgE-blocking factor values||||<0.001
71009244|NCT01454531|141526229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Paired samples|t-test, 2 sided|||The null hypothesis is no changes in Phleum specific IgG4 values from visit 1 (baseline) to visit 6 (end of treatment) versus the alternative hypothesis of change in Phleum specific IgG4 values||||<0.001
71009245|NCT01454531|141526230|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Parallel Line Assay|||Parallel Line Assay is based on the construction of two dose-response regression lines obtained plotting the allergen concentration used to prick test the subjects against the wheal size obtained. ANOVA allows to check for regression, linearity and parallelism. A common slope and y-intercepts are calculated. The CTI is the exponentiation of the difference between y-intercepts divided by the common slope. (Finney D.J., Statistical Method in Biological Assay, 1978).||||<0.01
71009246|NCT01408862|141526235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.04|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||"Results will be expressed as mean + SD from independent experiments. Statistical significance between means were determined by Wilcoxon-paired test. Variable will be log-transformed if they were not normally distributed. . We used the CSS/ Statistica program package, StatSoft V 6.0.~This analysis applies to both GLP1R and GIPR categories"||||0.04
71009247|NCT01408862|141526236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.2|||||||ANOVA|||Results will be expressed as mean + SD from independent experiments. Statistical significance between means were determined by two-way ANOVA with repeated measures on one factor, for variables measured in several consecutive times. Variable will be log-transformed if they were not normally distributed. Wilcoxon test for paired samples was used. The Statistica program package (StatSoft V 6.0) were used to perform these analyses, which applied to both GLP1R and GIPR agonist effect categories.||||0.20
71103138|NCT00023595|141714468|SUPERIORITY|||||||0.25||||||36 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.25
71009248|NCT01813149|141526238|SUPERIORITY|||||||0.009|||||||t-test, 2 sided|df=20 t-statistic = 2.90||A t-test to see if expression of α1-AR differs between phenylephrine responders and non-responders||||0.009
71009249|NCT01882439|141526252|SUPERIORITY_OR_OTHER||Risk Difference (RD)|25.95|STANDARD_ERROR_OF_MEAN|5.73|<|0.0001|TWO_SIDED|95.0|14.72|37.19|||Large sample approximation|Missing response (MR) = non-response (NR)||||37.19|14.72|<0.0001
71009250|NCT01882439|141526252|SUPERIORITY_OR_OTHER||Risk Difference (RD)|23.31|STANDARD_ERROR_OF_MEAN|5.71|<|0.0001|TWO_SIDED|95.0|12.1|34.51|||Large sample approximation|MR=NR||||34.51|12.10|<0.0001
71009251|NCT01882439|141526253|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2529|STANDARD_ERROR_OF_MEAN|0.06422|<|0.0001|TWO_SIDED|95.0|-0.3792|-0.1266|||Mixed Models Analysis|No imputation||||-0.1266|-0.3792|<0.0001
71009252|NCT01882439|141526253|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.215|STANDARD_ERROR_OF_MEAN|0.06453||0.0009|TWO_SIDED|95.0|-0.3419|-0.0881|||Mixed Models Analysis|No imputation||||-0.0881|-0.3419|0.0009
71009253|NCT03125902|141526291|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.2032|TWO_SIDED|95.0|0.6|1.12|||Log Rank|||Stratified Analysis||1.12|0.60|0.2032
71009254|NCT03125902|141526291|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.2601|TWO_SIDED|95.0|0.62|1.14|||Log Rank|||Unstratified Analysis||1.14|0.62|0.2601
71009255|NCT03125902|141526292|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.86||||0.1343|TWO_SIDED|95.0|0.7|1.05|||Log Rank|||||1.05|0.70|0.1343
71009256|NCT03125902|141526292|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.1285|TWO_SIDED|95.0|0.7|1.05|||Log Rank|||Unstratified Analysis||1.05|0.70|0.1285
71103139|NCT00023595|141714469|SUPERIORITY|||||||0.002||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.002
71103140|NCT00023595|141714469|SUPERIORITY|||||||0.007||||||12 months|Chi-squared|||||||0.007
71103141|NCT00023595|141714469|SUPERIORITY|||||||0.049||||||24 months|Chi-squared|||||||0.049
71103142|NCT00023595|141714469|SUPERIORITY|||||||0.038||||||36 months|Chi-squared|||||||0.038
70925960|NCT05235750|141345839|OTHER||Mean Difference (Net)|0.0||||0.62|TWO_SIDED|||||"The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for item Ge6 I worry that my condition will get worse as measured by the FACT-G."|Mixed Models Analysis||"The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for item Ge6 I worry that my condition will get worse as measured by the FACT-G."|||||.62
71045733|NCT02697773|141599482|SUPERIORITY||Least Square Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.15||0.0319|TWO_SIDED|95.0|-0.63|-0.03|||ANCOVA|||Week 1: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.03|-0.63|0.0319
70925961|NCT05235750|141345840|OTHER||Mean Difference (Net)|-0.6||||0.76|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the total FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the total FACIT-Sp-12.|We analyzed short- (at 6 weeks post-baseline, T3) and longer-term differences (at 8 weeks post-baseline, T4) for the FACIT-Sp-12 at scale and factor levels, expecting a larger size of differences at T3. The short-term difference \[(T3-T2)-(T2-T1)\] represents differences between post-intervention change (T3-T2) and pre-intervention change (T2-T1). Longer-term difference \[(T4-T2)-(T2-T1)\] represents differences between 2 weeks post-intervention change (T4-T2) and pre-intervention change (T2-T1).||||.76
70925962|NCT05235750|141345840|OTHER||Mean Difference (Net)|-2.1||||0.19|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the total FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the total FACIT-Sp-12.|||||.19
71009257|NCT03125902|141526293|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.5798|TWO_SIDED|95.0|0.76|1.64|||Log Rank|||Stratified Analysis||1.64|0.76|0.5798
71009258|NCT03125902|141526293|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.4035|TWO_SIDED|95.0|0.8|1.72|||Log Rank|||Unstratified Analysis||1.72|0.80|0.4035
71009259|NCT03125902|141526294|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.3425|TWO_SIDED|95.0|0.88|1.43|||Log Rank|||Stratified analysis||1.43|0.88|0.3425
71009260|NCT03125902|141526294|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.2166|TWO_SIDED|95.0|0.92|1.48|||Log Rank|||Unstratified Analysis||1.48|0.92|0.2166
71009261|NCT03125902|141526296|OTHER|Stratified analysis|Hazard Ratio (HR)|0.94||||0.6465|TWO_SIDED|95.0|0.71|1.24|||Log Rank|||||1.24|0.71|0.6465
71009262|NCT03125902|141526298|OTHER||Odds Ratio (OR)|1.44||||0.1526|TWO_SIDED|95.0|0.87|2.37|||Cochran-Mantel-Haenszel|||||2.37|0.87|0.1526
71009263|NCT03125902|141526299|OTHER||Odds Ratio (OR)|1.4||||0.1834|TWO_SIDED|95.0|0.85|2.31|||Cochran-Mantel-Haenszel|||||2.31|0.85|0.1834
71009264|NCT03125902|141526300|OTHER||Odds Ratio (OR)|1.42||||0.0513|TWO_SIDED|95.0|1.0|2.02|||Cochran-Mantel-Haenszel|||||2.02|1.00|0.0513
71009265|NCT03125902|141526301|OTHER||Odds Ratio (OR)|1.3||||0.1226|TWO_SIDED|95.0|0.93|1.81|||Cochran-Mantel-Haenszel|||||1.81|0.93|0.1226
71009266|NCT03125902|141526302|OTHER|Unstratified Analysis|Hazard Ratio (HR)|0.74||||0.0641|TWO_SIDED|95.0|0.54|1.02|||Log Rank|||||1.02|0.54|0.0641
71009267|NCT03125902|141526312|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.01227|TWO_SIDED|95.0|0.42|0.9|||Log Rank|||Unstratified Analysis||0.90|0.42|0.01227
71009268|NCT02269709|141526313|OTHER|Changes in mean liver shear wave speed (SWS) between time points were assessed using a mixed-effect model with post hoc Tukey correction.|||||<|0.0001|||||||Mixed Models Analysis|||Comparison of Baseline and Follow-up #1||||<0.0001
71009269|NCT02269709|141526313|OTHER|Changes in mean liver shear wave speed (SWS) between time points were assessed using a mixed-effect model with post hoc Tukey correction.|||||<|0.0001|||||||Mixed Models Analysis|||Comparison of Baseline vs. Follow up #2||||<0.0001
71009270|NCT02269709|141526313|OTHER|Changes in mean liver shear wave speed (SWS) between time points were assessed using a mixed-effect model with post hoc Tukey correction.|||||<|0.0001|||||||Mixed Models Analysis|||Comparison of Baseline vs. Follow-up #3||||<0.0001
71009271|NCT02269709|141526314|OTHER|Mean IVC pressures from different time points were compared using the Wilcoxon signed-rank test.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71009272|NCT02504424|141526315|OTHER||percent of breasts successfully exchange|100.0|||||ONE_SIDED|||||||||Treatment Success includes all breasts which were exchanged successfully in the Per Protocol Cohort, excluding non-device related failures. The Treatment Success Rate per breast is 100% (80/80). Note: Denominator = 80 (86 implanted breasts - 6 breasts). Failed exchange = 4 breasts (non-device related) \& Missing = 2 breasts (patient non-compliant w/study and withdrew consent after treatment).||||
71103143|NCT00023595|141714470|SUPERIORITY|||||||0.4||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.40
71103144|NCT00023595|141714470|SUPERIORITY|||||||0.37||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.37
71103145|NCT00023595|141714470|SUPERIORITY|||||||0.98||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.98
71103146|NCT00023595|141714470|SUPERIORITY|||||||0.15||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.15
71103147|NCT00023595|141714470|SUPERIORITY|||||||0.04||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.04
71103148|NCT00023595|141714471|SUPERIORITY|||||||0.036||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.036
71103149|NCT00023595|141714471|SUPERIORITY|||||||0.043||||||12 months|Chi-squared|||||||0.043
71103150|NCT00023595|141714471|SUPERIORITY|||||||0.018||||||24 months|Chi-squared|||||||0.018
71103151|NCT00023595|141714471|SUPERIORITY|||||||0.037||||||36 months|Chi-squared|||||||0.037
71103152|NCT00023595|141714472|SUPERIORITY|||||||0.75||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.75
71103153|NCT00023595|141714472|SUPERIORITY|||||||0.72||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.72
71103154|NCT00023595|141714472|SUPERIORITY|||||||0.77||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.77
71103155|NCT00023595|141714472|SUPERIORITY|||||||0.52||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.52
71103156|NCT00023595|141714472|SUPERIORITY|||||||0.12||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.12
70941323|NCT00985621|141383144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.49|-0.45|||ANCOVA|||Analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.45|-1.49|<0.001
71009273|NCT02504424|141526315|OTHER||% breasts successfully exchanged|100.0|||||ONE_SIDED|||||||||Sensitivity Analysis (Best / Worst Case): Treatment Success by subject for the Per Protocol cohort includes all failures (excluding non-device related failures). The best case analysis considers success if the subject has at least one breast successfully reconstructed, and the worst case analysis considers it a failure if at least one breast has failed. The treatment success by subject is 100% for both best and worst case analysis.||||
71009274|NCT02504424|141526316|OTHER||% breasts successfully exchanged|95.2|||||ONE_SIDED|||||||||Secondary analysis is repeated including all breasts in the PP cohort (including non-device related failures). The Treatment Success Rate by breast, based on the Per Protocol cohort, including all cause failures, is 95.2% (80/84). One subject (2 breasts) are not included in analysis as subject withdrew from the study prior to exchange of her expanders.||||
71103157|NCT00023595|141714473|SUPERIORITY|||||||0.0002||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.0002
70925963|NCT05235750|141345840|OTHER||Mean Difference (Net)|-1.0||||0.35|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the Meaning/Peace factor (M/P) as measured by the FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the Meaning/Peace factor (M/P) as measured by the FACIT-Sp-12.|||||.35
71045734|NCT02697773|141599482|SUPERIORITY||Least Square Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.15||0.0139|TWO_SIDED|95.0|-0.68|-0.08|||ANCOVA|||Week 1:Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.08|-0.68|0.0139
71045735|NCT02697773|141599482|SUPERIORITY||Least Square Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.2||0.0011|TWO_SIDED|95.0|-1.03|-0.25|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.25|-1.03|0.0011
71103158|NCT00023595|141714473|SUPERIORITY||||||<|0.0001||||||12 months|Chi-squared|||||||<0.0001
71103159|NCT00023595|141714473|SUPERIORITY|||||||0.009||||||24 months|Chi-squared|||||||0.009
71103160|NCT00023595|141714473|SUPERIORITY|||||||0.32||||||36 months|Chi-squared|||||||0.32
71045736|NCT02697773|141599482|SUPERIORITY||Least Square Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.2||0.0053|TWO_SIDED|95.0|-0.93|-0.16|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.16|-0.93|0.0053
71045737|NCT02697773|141599482|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.21||0.0014|TWO_SIDED|95.0|-1.08|-0.26|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.26|-1.08|0.0014
71103161|NCT00023595|141714474|SUPERIORITY|||||||0.6||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.60
71103162|NCT00023595|141714474|SUPERIORITY|||||||0.14||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.14
71103163|NCT00023595|141714474|SUPERIORITY|||||||0.57||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.57
71103164|NCT00023595|141714474|SUPERIORITY|||||||0.15||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.15
71103165|NCT00023595|141714474|SUPERIORITY|||||||0.84||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.84
71103166|NCT00023595|141714475|SUPERIORITY||||||<|0.0001||||||Hospital costs|Wilcoxon (Mann-Whitney)|||||||<0.0001
71103167|NCT00023595|141714475|SUPERIORITY||||||<|0.0001||||||Physician fees|Wilcoxon (Mann-Whitney)|||||||<0.0001
71103168|NCT00023595|141714475|SUPERIORITY||||||<|0.0001||||||Total index cost|Wilcoxon (Mann-Whitney)|||||||<0.0001
71103169|NCT00023595|141714476|SUPERIORITY|||||||0.006||||||Hospital costs|Wilcoxon (Mann-Whitney)|||||||0.006
71103170|NCT00023595|141714476|SUPERIORITY||||||<|0.0001||||||Physician fees|Wilcoxon (Mann-Whitney)|||||||<0.0001
71103171|NCT00023595|141714476|SUPERIORITY|||||||0.004||||||Total index cost|Wilcoxon (Mann-Whitney)|||||||0.004
71103172|NCT01472185|141714477|SUPERIORITY_OR_OTHER||difference in least squares mean (LSM)|-0.56|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.36||P-value is from a mixed effects model including terms for baseline HbA1c value, treatment group, visit week, and treatment by visit week interaction. Unstructured covariance matrix was used.|Mixed Effects Model Analysis||The estimation (LSM) is of the placebo-corrected change from baseline.|Assuming a common standard deviation of 1.2%, an effective sample size of 400 would provide at least 90% power to detect a statistically significant treatment difference of -0.5% (ranolazine vs. placebo) for the reduction of HbA1c from baseline at Week 24 based on a 2-sided alpha of 0.05 and 1:1 randomization.||-0.36|-0.76|< 0.0001
71103173|NCT00635050|141714491|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.28|||||TWO_SIDED|||||||||||||
71103174|NCT00086515|141714500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|||<|0.001|TWO_SIDED|95.0|-0.77|-0.53|||ANCOVA|Model terms: treatment, prior AHA status (not on AHA, on monotherapy oral AHA, or on metformin-based oral combination AHA), and baseline A1C||||-0.53|-0.77|<0.001
71103175|NCT00086515|141714501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.4|||<|0.001|TWO_SIDED|95.0|-31.0|-19.8|||ANCOVA|Model terms: treatment, prior AHA status (not on AHA, on monotherapy oral AHA, or on metformin-based oral combination AHA), and baseline FPG||||-19.8|-31.0|<0.001
71103176|NCT00086515|141714502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.6|||<|0.001|TWO_SIDED|95.0|-60.5|-40.8|||ANCOVA|Model terms: treatment, prior AHA status (not on AHA, on monotherapy oral AHA, or on metformin-based oral combination AHA), and baseline 2-hour PMG||||-40.8|-60.5|<0.001
71103177|NCT00049543|141714503|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||0.14|TWO_SIDED|95.0|0.94|1.64|||Log Rank|||The Kaplan-Meier estimates of survival distribution for overall survival by treatment arm are reported, and the log rank test stratified by the stratification factors at randomization (exclude center) was used to compare the difference in the overall survival between two treatment arms. Hazard ratio of comparison of study treatment arm to placebo and it 95% C.I. were reported.||1.64|0.94|0.14
71103178|NCT00049543|141714504|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22||||0.15|TWO_SIDED|95.0|0.93|1.61||Stratified by stratification factors at randomization (except center)|Log Rank|Stratified by stratification factors at randomization (except center)||||1.61|0.93|0.15
70925964|NCT05235750|141345840|OTHER||Mean Difference (Net)|-1.9||||0.99|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the Meaning/Peace factor (M/P) as measured by the FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the Meaning/Peace factor (M/P) as measured by the FACIT-Sp-12.|||||.99
71103179|NCT02106832|141714506|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7062||||0.0511|TWO_SIDED|99.9|0.3928|1.2698|||Wald-type test|||The hazard ratio for time to first exacerbation event within 48 weeks and 99.9% Confidence Interval (CI) was calculated by using Cox proportional hazards model by comparison of Cipro 28/Pooled Placebo reporting groups. P-value was analysed using Wald-type test.||1.2698|0.3928|0.0511
71103180|NCT02106832|141714514|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8662||||0.3965|TWO_SIDED|95.1|0.6206|1.209|||Wald-type test|||The hazard ratio for time to first exacerbation event within 48 weeks and 95.1% Confidence Interval (CI) was calculated by using Cox proportional hazards model by comparison of Cipro 28/Pooled Placebo reporting groups. P-value was analysed using Wald-type test.||1.2090|0.6206|0.3965
71103181|NCT00265122|141714526|SUPERIORITY_OR_OTHER|||||||0.337||95.0||||The P-Value is from a Cochran-Mantel-Haenszel (CMH) test stratified by the route of administration.|Cochran-Mantel-Haenszel|||Null hypothesis: No difference between ustekinumab and placebo at a significant level of 0.05.||||0.337
71103182|NCT00265122|141714528|SUPERIORITY_OR_OTHER|||||||0.292||95.0||||The P-Value is from a CMH test stratified by the route of administration.|Cochran-Mantel-Haenszel|||||||0.292
71103183|NCT00608062|141714530|OTHER|Repeated measurements of FMD were modeled using a general linear mixed model with maximum likelihood estimation. An unstructured covariance structure allowing for heterogeneity in the parameter estimate for each level of menopause stage was chosen for the model based on using AIC to compare various covariance structures.||||||0.05|||||||Mixed Models Analysis|||||||0.05
71103184|NCT00608062|141714532|OTHER|Similar analyses as primary outcome||||||0.05|||||||Mixed Models Analysis|||||||0.05
70925965|NCT05235750|141345840|OTHER||Mean Difference (Net)|0.4||||0.46|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the Faith factor of the FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the Faith factor of the FACIT-Sp-12.|||||.46
71103185|NCT00608062|141714533|OTHER|same analysis as primary outcome||||||0.05|||||||Mixed Models Analysis|||||||0.05
71103186|NCT04992065|141714539|SUPERIORITY||Treatment difference|-31.95|||<|0.0001|TWO_SIDED|95.0|-43.02|-20.87|||ANCOVA|||LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.||-20.87|-43.02|<.0001
71103187|NCT04992065|141714539|SUPERIORITY||Treatment difference|-44.91|||<|0.0001|TWO_SIDED|95.0|-56.04|-33.79|||ANCOVA|||LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.||-33.79|-56.04|<.0001
71103188|NCT04992065|141714539|SUPERIORITY||Treatment difference|-61.83|||<|0.0001|TWO_SIDED|95.0|-72.94|-50.72|||ANCOVA|||LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.||-50.72|-72.94|<.0001
71103189|NCT04992065|141714539|SUPERIORITY||Treatment difference|33.32|||||TWO_SIDED|95.0|22.16|44.47||||||LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.||44.47|22.16|
71103190|NCT04992065|141714539|SUPERIORITY||Treatment difference|20.35|||||TWO_SIDED|95.0|9.21|31.48||||||LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.||31.48|9.21|
71103191|NCT04992065|141714539|SUPERIORITY||Treatment difference|3.43|||||TWO_SIDED|95.0|-7.81|14.68||||||LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.||14.68|-7.81|
71103192|NCT00663260|141714548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.1448||0.561|TWO_SIDED|95.0|-0.37|0.2||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment|ANCOVA|||||0.20|-0.37|0.561
71103193|NCT00663260|141714548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.1457||0.435|TWO_SIDED|95.0|-0.4|0.17||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment|ANCOVA|||||0.17|-0.40|0.435
71103194|NCT00663260|141714549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.6|STANDARD_ERROR_OF_MEAN|8.142|||TWO_SIDED|95.0|-29.7|2.4||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05; secondary efficacy analyses were not tested since the primary endpoint was not significant.|ANCOVA|||||2.4|-29.7|
71103195|NCT00663260|141714549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|STANDARD_ERROR_OF_MEAN|8.136|||TWO_SIDED|95.0|-25.0|7.0||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05; secondary efficacy analyses were not tested since the primary endpoint was not significant.|ANCOVA|||||7.0|-25.0|
71103196|NCT00663260|141714550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|0.4435|||TWO_SIDED|95.0|-2.68|-0.94||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05; secondary efficacy analyses were not tested since the primary endpoint was not significant.|ANCOVA|||||-0.94|-2.68|
71103197|NCT00663260|141714550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.16|STANDARD_ERROR_OF_MEAN|0.4395|||TWO_SIDED|95.0|-3.03|-1.29||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05; secondary efficacy analyses were not tested since the primary endpoint was not significant.|ANCOVA|||||-1.29|-3.03|
71103198|NCT02231580|141714564|SUPERIORITY_OR_OTHER||GLS mean ratio|1.104|||=|0.5743|TWO_SIDED|90.0|0.823|1.482|||MMRM|||Left hand position-index statistical analysis is presented (BN82451B versus Placebo). The Mixed Effect Model Repeat Measurement (MMRM) analysis was performed on log-transformed data using the restricted maximum likelihood (REML) model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.482|0.823|=0.5743
71045738|NCT02697773|141599482|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.21||0.0002|TWO_SIDED|95.0|-1.17|-0.36|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.36|-1.17|0.0002
71045739|NCT02697773|141599482|SUPERIORITY||Least Square Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.33|-0.49|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.49|-1.33|<.0001
71045740|NCT02697773|141599482|SUPERIORITY||Least Square Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.36|-0.52|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.52|-1.36|<.0001
71045741|NCT02697773|141599482|SUPERIORITY||Least Square Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.23||0.0015|TWO_SIDED|95.0|-1.16|-0.28|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.28|-1.16|0.0015
71045742|NCT02697773|141599482|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.22||0.0023|TWO_SIDED|95.0|-1.12|-0.24|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.24|-1.12|0.0023
71045743|NCT02697773|141599482|SUPERIORITY||Least Square Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.23||0.0512|TWO_SIDED|95.0|-0.89|0.0|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||0.00|-0.89|0.0512
71045744|NCT02697773|141599482|SUPERIORITY||Least Square Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.22||0.0693|TWO_SIDED|95.0|-0.85|0.03|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||0.03|-0.85|0.0693
71045745|NCT02697773|141599482|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.24||0.0043|TWO_SIDED|95.0|-1.14|-0.21|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.21|-1.14|0.0043
71045746|NCT02697773|141599482|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.23||0.0041|TWO_SIDED|95.0|-1.13|-0.21|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.21|-1.13|0.0041
71045747|NCT02697773|141599482|SUPERIORITY||Least Square Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.24||0.0024|TWO_SIDED|95.0|-1.19|-0.26|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.26|-1.19|0.0024
71045748|NCT02697773|141599482|SUPERIORITY||Least Square Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.24||0.0015|TWO_SIDED|95.0|-1.22|-0.29|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.29|-1.22|0.0015
71045749|NCT02697773|141599482|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.25||0.0063|TWO_SIDED|95.0|-1.16|-0.19|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.19|-1.16|0.0063
71103199|NCT02231580|141714564|SUPERIORITY_OR_OTHER||GLS mean ratio|1.141|||=|0.4349|TWO_SIDED|90.0|0.862|1.51|||MMRM|||Right hand position-index statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.510|0.862|=0.4349
71103200|NCT02231580|141714565|SUPERIORITY_OR_OTHER||GLS mean ratio|1.035|||=|0.8937|TWO_SIDED|90.0|0.675|1.587|||MMRM|||Left hand orientation-index statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.587|0.675|=0.8937
71103201|NCT02231580|141714565|SUPERIORITY_OR_OTHER||GLS mean ratio|1.093|||=|0.636|TWO_SIDED|90.0|0.8|1.493|||MMRM|||Right hand orientation-index statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.493|0.800|=0.6360
71103202|NCT02231580|141714566|SUPERIORITY_OR_OTHER||GLS mean ratio|1.247|||=|0.2865|TWO_SIDED|90.0|0.886|1.756|||MMRM|||Left hand grip force variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.756|0.886|=0.2865
71103203|NCT02231580|141714566|SUPERIORITY_OR_OTHER||GLS mean ratio|1.16|||=|0.5338|TWO_SIDED|90.0|0.781|1.724|||MMRM|||Right hand grip force variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.724|0.781|=0.5338
71103204|NCT02231580|141714567|SUPERIORITY_OR_OTHER||GLS mean ratio|0.693|||=|0.0864|TWO_SIDED|90.0|0.487|0.985|||MMRM|||Left hand isometric grip forces statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||0.985|0.487|=0.0864
71103205|NCT02231580|141714567|SUPERIORITY_OR_OTHER||GLS mean ratio|0.686|||=|0.0399|TWO_SIDED|90.0|0.508|0.925|||MMRM|||Right hand isometric grip forces statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||0.925|0.508|=0.0399
71103206|NCT02231580|141714568|SUPERIORITY_OR_OTHER||GLS mean ratio|1.509|||=|0.0574|TWO_SIDED|90.0|1.06|2.15|||MMRM|||Left finger IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.150|1.060|=0.0574
71009275|NCT00890396|141526317|SUPERIORITY|||||||0.67|||||||Fisher Exact|||The primary analysis compared the frequency of worsening spleen function (from normal to decreased or absent, or from decreased to absent).||||0.67
71103207|NCT02231580|141714568|SUPERIORITY_OR_OTHER||GLS mean ratio|0.953|||=|0.8277|TWO_SIDED|90.0|0.662|1.372|||MMRM|||Right finger IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.372|0.662|=0.8277
71103208|NCT02231580|141714568|SUPERIORITY_OR_OTHER||GLS mean ratio|1.238|||=|0.0162|TWO_SIDED|90.0|1.074|1.426|||MMRM|||Left finger IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.426|1.074|=0.0162
71103209|NCT02231580|141714568|SUPERIORITY_OR_OTHER||GLS mean ratio|1.038|||=|0.632|TWO_SIDED|90.0|0.912|1.182|||MMRM|||Right finger IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.182|0.912|=0.6320
71103210|NCT02231580|141714569|SUPERIORITY_OR_OTHER||GLS mean ratio|1.308|||=|0.3005|TWO_SIDED|90.0|0.85|2.014|||MMRM|||Left finger variability of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.014|0.85|=0.3005
71103211|NCT02231580|141714569|SUPERIORITY_OR_OTHER||GLS mean ratio|1.177|||=|0.4793|TWO_SIDED|90.0|0.804|1.722|||MMRM|||Right finger variability of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.722|0.804|=0.4793
71103212|NCT02231580|141714569|SUPERIORITY_OR_OTHER||GLS mean ratio|1.15|||=|0.2653|TWO_SIDED|90.0|0.934|1.416|||MMRM|||Left finger duration of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.416|0.934|=0.2653
71103213|NCT02231580|141714569|SUPERIORITY_OR_OTHER||GLS mean ratio|1.045|||=|0.6777|TWO_SIDED|90.0|0.875|1.248|||MMRM|||Right finger duration of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.248|0.875|=0.6777
71103214|NCT02231580|141714570|SUPERIORITY_OR_OTHER||GLS mean ratio|1.618|||=|0.0326|TWO_SIDED|90.0|1.124|2.331|||MMRM|||Left finger IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.331|1.124|=0.0326
71009276|NCT00890396|141526318|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||The primary analysis compared the frequency of worsening spleen function (from normal to decreased or absent, or from decreased to absent).||||>0.99
71045750|NCT02697773|141599482|SUPERIORITY||Least Square Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.24||0.0008|TWO_SIDED|95.0|-1.3|-0.34|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.34|-1.30|0.0008
71045751|NCT02697773|141599484|SUPERIORITY||Least Square Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.47|-0.61|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.61|-1.47|<.0001
71009277|NCT00890396|141526319|SUPERIORITY|||||||0.61|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.61
71009278|NCT00890396|141526320|SUPERIORITY|||||||0.78|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.78
71009279|NCT00890396|141526321|SUPERIORITY|||||||0.8|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.80
71009280|NCT00890396|141526322|SUPERIORITY|||||||0.11|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.11
71009281|NCT00890396|141526323|SUPERIORITY|||||||0.85|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.85
71009282|NCT00890396|141526324|SUPERIORITY|||||||0.95|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.95
71009283|NCT00890396|141526325|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.40
71009284|NCT00890396|141526326|SUPERIORITY|||||||0.11|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.11
71009285|NCT00440232|141526327|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.969||||0.172|TWO_SIDED|95.0|0.74|5.235|||Chi-squared|||||5.235|0.74|0.172
71009286|NCT00440232|141526328|SUPERIORITY_OR_OTHER||log rank chi square|1.247||||0.264||95.0|||||Log Rank|df=1||||||0.264
71009287|NCT00362297|141526329|SUPERIORITY_OR_OTHER_LEGACY||Incident Risk Ratio|0.79||||0.052||95.0|0.63|1.0|||Regression, Poisson|Adjusted for period effects.||Comparison of genital HSV shedding rate on high dose acyclovir to standard dose valacyclovir. Powered with 80% chance of detecting 50% reduction in genital shedding rate on high dose acyclovir compared to standard dose valacyclovir.||1.00|0.63|0.052
71009288|NCT03512028|141526341|SUPERIORITY||Mean Difference (Net)|3.2||||0.002|TWO_SIDED|||||Interaction effect of group x time from pre- to post- intervention|ANOVA||Estimated difference between slopes|Mixed model ANOVA with group (RLIC, Sham) and time (pre-, post-, and follow-up ). The main analysis of interest is the group x time interaction from pre- to post-.||||0.002
71009289|NCT03512028|141526341|SUPERIORITY|||||||0.001||||||Main effect of time|ANOVA|||||||0.001
71009290|NCT03512028|141526341|SUPERIORITY|||||||0.844||||||Main effect of group|ANOVA|||||||0.844
71009291|NCT01259388|141526344|SUPERIORITY_OR_OTHER_LEGACY|||||||0.346|||||||t-test, 2 sided|||||||0.346
71009292|NCT01259388|141526346|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
71009293|NCT02743494|141526347|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0003|TWO_SIDED|96.4|0.56|0.86|||Stratified log-rank test||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab over Placebo.|||0.86|0.56|0.0003
71009294|NCT01032265|141526370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27||95.0|||||Mixed Models Analysis|||analysis between groups||||0.27
71009295|NCT01032265|141526371|SUPERIORITY_OR_OTHER_LEGACY|||||||0.52||95.0|||||Mixed Models Analysis|||analysis between groups||||0.52
71009296|NCT01032265|141526372|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3||95.0|||||Mixed Models Analysis|||analysis between groups||||0.30
71009297|NCT01032265|141526373|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||analysis between groups||||0.02
71009298|NCT01032265|141526374|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||analysis between groups||||<0.001
71009299|NCT01032265|141526375|SUPERIORITY_OR_OTHER_LEGACY|||||||0.23||95.0|||||negative binomial regression|||analysis between groups||||0.23
71009300|NCT01032265|141526376|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0|||||Wilcoxon (Mann-Whitney)|||analysis between groups||||0.01
71009301|NCT02728804|141526378|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.65|TWO_SIDED|95.0|0.66|1.29|||Regression, Cox|Covariate adjustment for insurance status, education, and sex.||||1.29|0.66|0.65
71009302|NCT02728804|141526379|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.7|TWO_SIDED|95.0|0.79|1.43|||Regression, Cox|Covariate adjustment for insurance status, education, and sex.||||1.43|0.79|0.70
71009303|NCT02728804|141526380|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.87|TWO_SIDED|95.0|0.73|1.31|||Regression, Cox|Covariate adjustment for insurance status, education, and sex.||||1.31|0.73|0.87
71009304|NCT02728804|141526381|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.01|TWO_SIDED|95.0|0.48|0.92|||Regression, Cox|Covariate adjustment for insurance status, education, and sex.||||0.92|0.48|0.01
71009305|NCT02728804|141526382|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.1|TWO_SIDED|95.0|0.95|1.87|||Regression, Cox|Covariate adjustment for insurance status, education, and sex.||||1.87|0.95|0.10
70925966|NCT05235750|141345840|OTHER||Mean Difference (Net)|-0.7||||0.24|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the Faith factor of the FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the Faith factor of the FACIT-Sp-12.|||||.24
70925967|NCT05235750|141345840|OTHER||Mean Difference (Net)|-0.4||||0.55|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the revised Faith factor of the FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the revised Faith factor of the FACIT-Sp-12.|||||.55
70925968|NCT05235750|141345840|OTHER||Mean Difference (Net)|-0.9||||0.8|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the revised Faith factor of the FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the revised Faith factor of the FACIT-Sp-12.|||||.80
70925969|NCT05235750|141345840|OTHER||Mean Difference (Net)|-1.5||||0.34|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the total FACIT-Sp-12 (revised).|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the total FACIT-Sp-12 (revised).|||||.34
70925970|NCT05235750|141345840|OTHER||Mean Difference (Net)|-3.0||||0.91|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the total FACIT-Sp-12 (revised).|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the total FACIT-Sp-12 (revised).|||||.91
70925971|NCT05235750|141345841|OTHER||Mean Difference (Net)|1.1||||0.14|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for HADS-anxiety subscale (HADS-A).|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for HADS-anxiety subscale (HADS-A).|We analyzed short- (at 6 weeks post-baseline, T3) and longer-term differences (at 8 weeks post-baseline, T4) for two subscales HADS-A and HADS-D respectively, expecting a larger size of differences at T3. The short-term difference \[(T3-T2)-(T2-T1)\] represents differences between post-intervention change (T3-T2) and pre-intervention change (T2-T1). Longer-term difference \[(T4-T2)-(T2-T1)\] represents differences between 2 weeks post-intervention change (T4-T2) and pre-intervention change (T2-T1).||||.14
71009306|NCT02728804|141526382|SUPERIORITY||Hazard Ratio (HR)|1.92||||0.002|TWO_SIDED|95.0|1.28|2.89|||Regression, Cox|Covariate adjustment for insurance status, education, and sex.||||2.89|1.28|0.002
71009307|NCT02475564|141526414|SUPERIORITY_OR_OTHER|||||||0.7|||||||Mann-Whitney test|||A sample size of at least 21 patients per arm would be necessary to have a 90% chance of detecting, as significant at the 1% level, a difference of 3 points in a scale of 10 points, between both groups as the primary outcome, after 42 days of treatment.||||0.7
71009308|NCT02475564|141526415|SUPERIORITY_OR_OTHER|||||||0.1|||||||Mann-Whitney test|||||||0.1
71009309|NCT02475564|141526416|SUPERIORITY_OR_OTHER|||||||0.8|||||||Mann-Whitney test|||||||0.8
71009310|NCT01906489|141526427|SUPERIORITY||Odds Ratio (OR)|11.4739|||=|0.0001|TWO_SIDED|95.0|3.3505|39.2931|||Fisher Exact|||||39.2931|3.3505|=0.0001
71009311|NCT01906489|141526428|OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
71009312|NCT01906489|141526429|OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71009313|NCT01906489|141526431|OTHER||||||=|0.0953|TWO_SIDED||||||Fisher Exact|||||||=0.0953
71009314|NCT01906489|141526432|OTHER||||||=|0.1238|TWO_SIDED||||||Fisher Exact|||||||=0.1238
71009315|NCT01906489|141526433|OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
71009316|NCT01906489|141526434|OTHER||||||=|0.0019|||||||t-test, 2 sided|||Week 2||||=0.0019
71009317|NCT01906489|141526434|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 4||||<0.0001
71009318|NCT01906489|141526434|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 6||||<0.0001
71009319|NCT01906489|141526434|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 8||||<0.0001
71009320|NCT01906489|141526434|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 12||||<0.0001
71009321|NCT01906489|141526434|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 16||||<0.0001
71009322|NCT01906489|141526434|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 19||||<0.0001
71009323|NCT01906489|141526434|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 20||||<0.0001
71009324|NCT01906489|141526436|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 2||||<0.0001
71009325|NCT01906489|141526436|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 4||||<0.0001
71009326|NCT01906489|141526436|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 6||||<0.0001
71009327|NCT01906489|141526436|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 8||||<0.0001
71009328|NCT01906489|141526436|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 12||||<0.0001
71009329|NCT01906489|141526436|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 16||||<0.0001
71009330|NCT01906489|141526436|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 19||||<0.0001
71009331|NCT01906489|141526436|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 20||||<0.0001
71009332|NCT01906489|141526438|OTHER||||||=|0.0031|||||||t-test, 2 sided|||Week 2||||=0.0031
71009333|NCT01906489|141526438|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 4||||<0.0001
71009334|NCT01906489|141526438|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 6||||<0.0001
71009335|NCT01906489|141526438|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 8||||<0.0001
71009336|NCT01906489|141526438|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 12||||<0.0001
71009337|NCT01906489|141526438|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 16||||<0.0001
71009338|NCT01906489|141526438|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 19||||<0.0001
70925972|NCT05235750|141345841|OTHER||Mean Difference (Net)|1.2||||0.14|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for HADS-anxiety subscale (HADS-A).|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for HADS-anxiety subscale (HADS-A).|||||.14
71009339|NCT01906489|141526438|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 20||||<0.0001
71009340|NCT01906489|141526440|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 2||||<0.0001
71009341|NCT01906489|141526440|OTHER||||||=|0.0133|||||||t-test, 2 sided|||Week 4||||=0.0133
71009342|NCT01906489|141526440|OTHER||||||=|0.3053|||||||t-test, 2 sided|||Week 6||||=0.3053
71009343|NCT01906489|141526440|OTHER||||||=|0.1918|||||||t-test, 2 sided|||Week 8||||=0.1918
71009344|NCT01906489|141526440|OTHER||||||=|0.209|||||||t-test, 2 sided|||Week 12||||=0.2090
71009345|NCT01906489|141526440|OTHER||||||=|0.6184|||||||t-test, 2 sided|||Week 16||||=0.6184
71009346|NCT01906489|141526440|OTHER||||||=|0.3604|||||||t-test, 2 sided|||Week 19||||=0.3604
71009347|NCT01906489|141526440|OTHER||||||=|0.4056|||||||t-test, 2 sided|||Week 20||||=0.4056
71009348|NCT01906489|141526446|OTHER||Hazard Ratio (HR)|4.1451|||=|0.0017|TWO_SIDED|95.0|1.5752|10.908|||Log Rank|||||10.9080|1.5752|=0.0017
71009349|NCT02551874|141526483|NON_INFERIORITY|Noninferiority was defined by upper bound of 95% CI \<0.3%|Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.085||0.118|TWO_SIDED|95.0|-0.3|0.03||Superiority|Mixed Models Analysis|Adjusted for treatment, baseline HbA1c, randomization stratification factor, visit, treatment-by-visit, and baseline HbA1c-by-visit.||||0.03|-0.30|0.118
71009350|NCT02551874|141526484|SUPERIORITY||Mean Difference (Final Values)|-3.64|STANDARD_ERROR_OF_MEAN|0.282|<|0.001|TWO_SIDED|95.0|-4.2|-3.09|||Mixed Models Analysis|Adjusted for treatment, baseline body weight, randomization stratification factor, visit, treatment-by-visit, and baseline body weight-by-visit.||||-3.09|-4.20|<0.001
71009351|NCT02551874|141526485|SUPERIORITY||Odds Ratio (OR)|0.4|||<|0.001|TWO_SIDED|95.0|0.3|0.62|||Regression, Logistic|Adjusted for baseline HbA1c and randomization stratification factor (background medication of metformin with or without SU).||||0.62|0.30|<0.001
71009352|NCT02551874|141526486|SUPERIORITY||Odds Ratio (OR)|1.8||||0.008|TWO_SIDED|95.0|1.16|2.67|||Regression, Logistic|||||2.67|1.16|0.008
71009353|NCT02551874|141526487|NON_INFERIORITY|Noninferiority was defined by lower bound of 95% CI \>-10%.|Adjusted Percent Difference|-0.4|||||TWO_SIDED|95.0|-7.42|6.54||||||||6.54|-7.42|
71009354|NCT02551874|141526488|NON_INFERIORITY|Noninferiority was defined by upper bound of 95% CI \<12 mg/dL.|Mean Difference (Final Values)|-19.99|STANDARD_ERROR_OF_MEAN|3.55|<|0.0001|TWO_SIDED|95.0|-26.98|-13.0|||Mixed Models Analysis|Adjusted for treatment, baseline measurement, randomization stratification factor, visit, treatment-by-visit, and baseline-by-visit.||||-13.00|-26.98|<0.0001
71009355|NCT01491802|141526509|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.090
71009356|NCT01491802|141526510|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.680
71009357|NCT01491802|141526511|SUPERIORITY|||||||0.197|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.197
71009358|NCT01491802|141526512|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.006
71009359|NCT01491802|141526513|SUPERIORITY|||||||0.044|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.044
71009360|NCT01491802|141526514|SUPERIORITY|||||||0.573|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.573
71009361|NCT01491802|141526515|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.960
71009362|NCT01491802|141526516|SUPERIORITY|||||||0.944|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.944
71009363|NCT01491802|141526517|SUPERIORITY|||||||0.028|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.028
71009364|NCT02600715|141526521|EQUIVALENCE|Test for differences in continuous variables.||||||0.94||||||Two-sided alpha of 0.05 was used to determine statistical significance.|Kruskal-Wallis|||||||0.94
71009365|NCT02615158|141526533|EQUIVALENCE|If the 95% confidence interval of the difference in the change over time does not include 0, it means that there is a significant difference in the change over time between the two groups.|Slope|0.07|STANDARD_ERROR_OF_MEAN|0.12||0.555|TWO_SIDED|95.0|-0.17|0.31||The alpha for statistical significance is set at 0.05.|Mixed Models Analysis||This is to compare change in maternal lifestyle group to child safety group.|H0: There are no differences between the maternal lifestyle and child safety groups in the change in BMI z-score over time. Mixed models included the interaction between time and intervention, accounting for clustering of the repeated measures within each individual.||0.31|-0.17|0.555
71009366|NCT02615158|141526533|EQUIVALENCE|95% CI|Slope|0.16|STANDARD_ERROR_OF_MEAN|0.12||0.2|TWO_SIDED|95.0|-0.08|0.39||Two-side test|Mixed Models Analysis||This is to compare the Responsive Parenting to the safety intervention group.|||0.39|-0.08|0.200
71009367|NCT02615158|141526534|EQUIVALENCE|95% confidence interval (CI) was estimated. If the 95% CI does not include 0, it means there is significant difference in the change over time between the two groups.|Slope|-0.11|STANDARD_ERROR_OF_MEAN|0.32||0.739|TWO_SIDED|95.0|-0.74|0.52||The alpha for statistical significance is set at 0.05|Mixed Models Analysis||This is to compare maternal lifestyle to child safety group.|H0: There is no difference between maternal lifestyle and child safety groups in the change of BMI over time.||0.52|-0.74|0.739
71009368|NCT02615158|141526534|EQUIVALENCE|The 95% CI was estimated. If it does not include 0, it means that there is a statistically significant difference in the change over time between the two groups.|Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.32||0.904|TWO_SIDED|95.0|-0.66|0.59||The alpha for statistical significance was set at 0.05.|Mixed Models Analysis||This is to compare the responsive parenting group to the child safety group.|H0: There are no differences in the change over time between responsive parenting and child safety groups.||0.59|-0.66|0.904
70925973|NCT05235750|141345841|OTHER||Median Difference (Net)|0.6||||0.32|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for HADS-depression subscale (HADS-D).|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for HADS-depression subscale (HADS-D).|||||.32
71103215|NCT02231580|141714570|SUPERIORITY_OR_OTHER||GLS mean ratio|0.886|||=|0.6016|TWO_SIDED|90.0|0.605|1.299|||MMRM|||Right finger IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.299|0.605|=0.6016
71103216|NCT02231580|141714570|SUPERIORITY_OR_OTHER||GLS mean ratio|1.242|||=|0.0152|TWO_SIDED|90.0|1.077|1.433|||MMRM|||Left finger IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.433|1.077|=0.0152
71103217|NCT02231580|141714570|SUPERIORITY_OR_OTHER||GLS mean ratio|1.042|||=|0.6033|TWO_SIDED|90.0|0.915|1.186|||MMRM|||Right finger IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.186|0.915|=0.6033
71103218|NCT02231580|141714571|SUPERIORITY_OR_OTHER||GLS mean ratio|1.657|||=|0.052|TWO_SIDED|90.0|1.086|2.529|||MMRM|||Left finger ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.529|1.086|=0.0520
71103219|NCT02231580|141714571|SUPERIORITY_OR_OTHER||GLS mean ratio|0.916|||=|0.6978|TWO_SIDED|90.0|0.63|1.333|||MMRM|||Right finger ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.333|0.630|=0.6978
70925974|NCT05235750|141345841|OTHER||Mean Difference (Net)|0.9||||0.2|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for HADS-depression subscale (HADS-D).|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for HADS-depression subscale (HADS-D).|||||.20
71103220|NCT02231580|141714571|SUPERIORITY_OR_OTHER||GLS mean ratio|1.298|||=|0.0522|TWO_SIDED|90.0|1.043|1.614|||MMRM|||Left finger ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.614|1.043|=0.0522
71103221|NCT02231580|141714571|SUPERIORITY_OR_OTHER||GLS mean ratio|1.014|||=|0.9012|TWO_SIDED|90.0|0.837|1.229|||MMRM|||Right finger ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.229|0.837|=0.9012
71103222|NCT02231580|141714572|SUPERIORITY_OR_OTHER||GLS mean ratio|1.198|||=|0.1779|TWO_SIDED|90.0|0.96|1.494|||MMRM|||Left finger TF statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.494|0.96|=0.1779
71103223|NCT02231580|141714572|SUPERIORITY_OR_OTHER||GLS mean ratio|0.966|||=|0.8036|TWO_SIDED|90.0|0.765|1.22|||MMRM|||Right finger TF statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.220|0.765|=0.8036
71103224|NCT02231580|141714573|SUPERIORITY_OR_OTHER||GLS mean ratio|0.812|||=|0.0177|TWO_SIDED|90.0|0.706|0.935|||MMRM|||Left finger freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||0.935|0.706|=0.0177
70925975|NCT02301910|141345849|NON_INFERIORITY|The calculation was carried out taking into account the power of 80%||||||0.87|||||||ANOVA|||||||0.87
71103225|NCT02231580|141714573|SUPERIORITY_OR_OTHER||GLS mean ratio|0.967|||=|0.6491|TWO_SIDED|90.0|0.856|1.093|||MMRM|||Right finger freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.093|0.856|=0.6491
71103226|NCT02231580|141714574|SUPERIORITY_OR_OTHER||GLS mean ratio|1.168|||=|0.6176|TWO_SIDED|90.0|0.697|1.955|||MMRM|||Left hand IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.955|0.697|=0.6176
71009369|NCT02615158|141526535|EQUIVALENCE|The 95% confidence interval (CI) for the difference in the change over time was estimated. If it does not include 0, it indicates significant difference in the change over time.|Slope|3.31|STANDARD_ERROR_OF_MEAN|2.4||0.168|TWO_SIDED|95.0|-1.4|8.02||Alpha is set at 0.05.|Mixed Models Analysis|||H0 is that there is no difference between maternal lifestyle and child safety groups in the change of HEI 2015 score over time.||8.02|-1.4|0.168
71045752|NCT02697773|141599484|SUPERIORITY||Least Mean Square Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.47|-0.62|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.62|-1.47|<.0001
71009370|NCT02615158|141526535|EQUIVALENCE|95% CI was estimated. If it does not include 0, it indicates that there is a significant difference in the change between the two groups.|Slope|0.82|STANDARD_ERROR_OF_MEAN|2.39||0.733|TWO_SIDED|95.0|-3.88|5.52|||Mixed Models Analysis||This is to compare the responsive feeding group to child safety group.|H0 is that there is no difference between the responsive parenting and child safety groups in the change of HEI score over time||5.52|-3.88|0.733
71009371|NCT02615158|141526536|EQUIVALENCE|The 95% CI was estimated. If it does not include 0, it indicates that there is significant difference in the change over time between the two groups.|Slope|3.3|STANDARD_ERROR_OF_MEAN|2.49||0.186|TWO_SIDED|95.0|-1.6|8.2||Alpha is set at 0.05.|Mixed Models Analysis||This is to compare the maternal lifestyle group to the child safety group.|Null hypothesis is that there are no differences between the two groups regarding the change of HEI 2015 score over time.||8.2|-1.6|0.186
71009372|NCT02615158|141526536|EQUIVALENCE|95% CI for the difference in change over time was estimated. If it does not include 0, it indicates that there is significant difference between the two groups.|Slope|-0.03|STANDARD_ERROR_OF_MEAN|2.51||0.99|TWO_SIDED|95.0|-4.97|4.91||Alpha is set to 0.05.|Mixed Models Analysis||This is to compare the responsive parenting group to child safety group.|H0 is there is no difference in the change of maternal HEI score over time between the two groups.||4.91|-4.97|0.990
71009373|NCT02615158|141526537|EQUIVALENCE|A 95% CI was estimated. If it does not include 0, it indicates significant difference in change over time between the two groups.|Slope|23.67|STANDARD_ERROR_OF_MEAN|11.03||0.034|TWO_SIDED|95.0|1.88|45.46||Alpha is set at 0.05.|Mixed Models Analysis||This is for maternal lifestyle group compared to safety control group.|Null hypothesis is there were no differences in the change over time for toddler MVPA across the two groups.||45.46|1.88|0.034
71009374|NCT02615158|141526537|EQUIVALENCE|H0 is that there is no difference between the change of MVPA over time between the two groups.|Slope|13.52|STANDARD_ERROR_OF_MEAN|10.89||0.216|TWO_SIDED|95.0|-7.98|35.03|||Mixed Models Analysis||This is to compare the responsive parenting group to child safety group.|||35.03|-7.98|0.216
71009375|NCT02615158|141526538|EQUIVALENCE|The 95% CI for the difference in the change between the two groups was estimated. If it does not include 0, it indicates that there is a significant difference by group in the change.|Slope|10.97|STANDARD_ERROR_OF_MEAN|4.82||0.024|TWO_SIDED|95.0|1.46|20.48|||Mixed Models Analysis||This is to compare the maternal lifestyle group to the child safety group.|H0 is that there is no difference in the change of maternal MVPA over time between the two groups.||20.48|1.46|0.024
71009376|NCT02615158|141526538|EQUIVALENCE|The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference.|Slope|0.98|STANDARD_ERROR_OF_MEAN|4.94||0.804|TWO_SIDED|95.0|-8.76|10.72|||Mixed Models Analysis||This is to compare responsive parenting group to child safety group.|H0 is that there is no significant difference in the change of maternal MVPA between the two groups.||10.72|-8.76|0.804
71009377|NCT02615158|141526539|EQUIVALENCE|The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference.|Slope|-0.36|STANDARD_ERROR_OF_MEAN|0.21||0.056|TWO_SIDED|95.0|-0.78|0.06||Alpha is set at 0.05 for statistical significance.|Mixed Models Analysis||This is to compare maternal lifestyle group to the child safety group.|The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference.||0.06|-0.78|0.056
71009378|NCT02615158|141526539|EQUIVALENCE|Alpha is set at 0.05 to indicate statistical significance.|Slope|0.03|STANDARD_ERROR_OF_MEAN|0.21||0.896|TWO_SIDED|95.0|-0.39|0.45|||Mixed Models Analysis||This is to compare responsive parenting group to child safety group.|The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference.||0.45|-0.39|0.896
71045753|NCT02697773|141599484|SUPERIORITY||Least Square Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.67|-0.81|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.81|-1.67|<.0001
71009379|NCT00104299|141526552|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin of -20%|Difference between group success rates|10.6|||<|0.001||95.1|-3.2|24.3||P-value is adjusted for interim analysis using a Lan-DeMets alpha spending function with an O'Brien-Fleming boundary, allocating 0.003 alpha to the interim analysis and 0.049 alpha to the final analysis.|95.1% CI of difference|Calculate 95.1% CI around the difference in success rates between arms. Lower bound above non-inferiority margin of -20% indicates non-inferiority.||In calculating the sample size, we assumed that the percentage of patients in both treatment groups would achieve disease remission off prednisone by 6 months was 70%. We specified a non-inferiority margin of -20% on the difference in remission rates (rituximab rate minus cyclophosphamide rate) and a one-sided 0.025 level test. Assuming a 10% dropout rate, RAVE required 100 patients in each arm to have 83% power to conclude non-inferiority.||24.3|-3.2|<0.001
71009380|NCT00104299|141526553|SUPERIORITY_OR_OTHER|||||||0.927||||||P-value is from the Poisson regression model adjusting for clinical study site and ANCA type. The natural logarithm of participant-months is used as an offset in this model|Poisson regression model|||Participant-months are defined as duration in months from the first study drug dosing date to the last date of the participant in the protocol. The rate of selected AEs is defined as the total number of selected AEs divided by total participant-months, and indicates the number of events per participant per month on average. Participants are grouped according to their originally received treatment.||||0.927
71009381|NCT00104299|141526554|SUPERIORITY_OR_OTHER||95.1% Confidence Interval of Difference|10.6||||0.133|TWO_SIDED|95.1|-3.2|24.4|||Chi-squared|At 6 months, the confidence interval is 95.1%.||The p-value is from a chi-square test.||24.4|-3.2|0.133
71103227|NCT02231580|141714574|SUPERIORITY_OR_OTHER||GLS mean ratio|0.759|||=|0.4541|TWO_SIDED|90.0|0.411|1.399|||MMRM|||Right hand IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.399|0.411|=0.4541
71103228|NCT02231580|141714574|SUPERIORITY_OR_OTHER||GLS mean ratio|1.119|||=|0.2018|TWO_SIDED|90.0|0.967|1.294|||MMRM|||Left hand IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.294|0.967|=0.2018
71103229|NCT02231580|141714574|SUPERIORITY_OR_OTHER||GLS mean ratio|1.046|||=|0.6527|TWO_SIDED|90.0|0.886|1.234|||MMRM|||Right hand IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.234|0.886|=0.6527
71103230|NCT02231580|141714575|SUPERIORITY_OR_OTHER||GLS mean ratio|0.929|||=|0.8279|TWO_SIDED|90.0|0.529|1.63|||MMRM|||Left hand variability of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.630|0.529|=0.8279
71103231|NCT02231580|141714575|SUPERIORITY_OR_OTHER||GLS mean ratio|0.612|||=|0.2738|TWO_SIDED|90.0|0.292|1.283|||MMRM|||Right hand variability of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.283|0.292|=0.2738
71103232|NCT02231580|141714575|SUPERIORITY_OR_OTHER||GLS mean ratio|1.018|||=|0.9218|TWO_SIDED|90.0|0.752|1.378|||MMRM|||Left hand duration of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.378|0.752|=0.9218
71103233|NCT02231580|141714575|SUPERIORITY_OR_OTHER||GLS mean ratio|0.847|||=|0.5032|TWO_SIDED|90.0|0.561|1.277|||MMRM|||Right hand duration of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.277|0.561|=0.5032
70925976|NCT04282148|141345858|SUPERIORITY||||||<|0.0001|||||||Z test using Kaplan Meier survival estim|||||||<0.0001
71103234|NCT02231580|141714576|SUPERIORITY_OR_OTHER||GLS mean ratio|1.14|||=|0.6759|TWO_SIDED|90.0|0.677|1.917|||MMRM|||Left hand IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.917|0.677|=0.6759
71103235|NCT02231580|141714576|SUPERIORITY_OR_OTHER||GLS mean ratio|0.815|||=|0.5764|TWO_SIDED|90.0|0.444|1.496|||MMRM|||Right hand IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.496|0.444|=0.5764
71103236|NCT02231580|141714576|SUPERIORITY_OR_OTHER||GLS mean ratio|1.115|||=|0.2127|TWO_SIDED|90.0|0.965|1.289|||MMRM|||Left hand IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.289|0.965|=0.2127
71045754|NCT02697773|141599484|SUPERIORITY||Least Square Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.66|-0.8|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.80|-1.66|<.0001
71045755|NCT02697773|141599484|SUPERIORITY||Least Square Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.23||0.0007|TWO_SIDED|95.0|-1.25|-0.33|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.33|-1.25|0.0007
71045756|NCT02697773|141599484|SUPERIORITY||Least Square Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.23||0.0013|TWO_SIDED|95.0|-1.2|-0.29|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.29|-1.20|0.0013
71009382|NCT00104299|141526555|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9||||0.761|TWO_SIDED|95.0|0.5|1.7||The log-rank test assesses the difference between the two treatment arms in the flaring pattern after complete remission|Log Rank|The log-rank test assesses the difference between the two treatment arms in the flaring pattern after complete remission||Participants are censored at the time of crossover, open label rituximab, or best medical judgement, if applicable. If a participant has no flare after complete remission prior to their Month 18 visit, the duration is censored at the date of the Month 18 Visit||1.7|0.5|0.761
71009383|NCT00104299|141526556|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9||||0.861|TWO_SIDED|95.0|0.6|1.5|||Log Rank|The log-rank test assesses the difference between the two treatment arms in the flaring pattern after remission||Participants are censored at the time of crossover, open label rituximab, or best medical judgement, if applicable. If a participant has no flare after complete remission prior to their Month 18 visit, the duration is censored at the date of the Month 18 Visit||1.5|0.6|0.861
71009384|NCT00104299|141526557|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.0||||0.497|TWO_SIDED|95.0|0.7|1.3|||Log Rank|The log-rank test assesses the difference between the two treatment arms in the pattern of achieving remission|The hazard ratio and confidence interval are based on a Cox proportional hazard model comparing rituximab to the control group, adjusting for clinical study site, ANCA type, and glucocorticoid use prior to baseline.|||1.3|0.7|0.497
71009385|NCT00104299|141526558|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.3||||0.147|TWO_SIDED|95.0|0.9|1.8|||Log Rank|The log-rank test assesses the difference between the two treatment arms in the pattern of achieving complete remission|The hazard ratio and confidence interval are based on a Cox proportional hazard model comparing rituximab to the control group, adjusting for clinical study site, ANCA type, and glucocorticoid use prior to baseline.|||1.8|0.9|0.147
71009386|NCT00104299|141526559|SUPERIORITY_OR_OTHER|||||||0.504||95.0|||||Chi-squared|||Proportions of subjects experiencing a serious adverse event through 18 months and prior to censoring for open-label, crossover, or best medical judgment according to originally assigned treatment arm were compared using a two-sided Chi-squared test.||||0.504
71045757|NCT02697773|141599484|SUPERIORITY||Least Square Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.51|-0.55|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.55|-1.51|<.0001
71045758|NCT02697773|141599484|SUPERIORITY||Least Square Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.67|-0.73|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.73|-1.67|<.0001
71009387|NCT00608426|141526567|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Regression, Logistic|||||||.02
71009388|NCT00608426|141526568|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||for the comparison of telephone counseling between the two groups|Mixed effects logistic regression|||||||<.001
71009389|NCT00608426|141526568|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED|||||for the comparison of in-person counseling between the two groups|Mixed effects logistic regression|||||||0.57
71009390|NCT00608426|141526568|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED|||||for the comparison of used medications between the two groups|Mixed effects logistic regression|||||||.15
71045759|NCT02697773|141599484|SUPERIORITY||Least Square Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.25||0.0007|TWO_SIDED|95.0|-1.32|-0.35|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.35|-1.32|0.0007
71045760|NCT02697773|141599484|SUPERIORITY||Least Square Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.48|-0.51|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.51|-1.48|<.0001
71009391|NCT00608426|141526568|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||for the comparison of combination counseling and medication between the two groups|Mixed effects logistic regression|||||||<.001
70925977|NCT04770532|141345879|NON_INFERIORITY|Non-inferiority of insulin icodec was considered confirmed if the upper limit of the two-sided 95% confidence interval (CI) for mean treatment difference (insulin icodec minus insulin degludec) was strictly below 0.3%.|Treatment difference|-0.22|||<|0.0001|TWO_SIDED|95.0|-0.37|-0.08|||ANCOVA|||The response and change from baseline in response after 26 weeks were analysed using an analysis of covariance (ANCOVA) model with treatment, region and personal continuous glucose monitoring (CGM) device use as fixed factors, and baseline response as covariate.||-0.08|-0.37|<0.0001
70925978|NCT04938492|141345890|SUPERIORITY||Slope|2.08|||>|0.05|TWO_SIDED||||||Latent growth modeling|||||||>.05
70925979|NCT04938492|141345891|SUPERIORITY||Slope|0.19|||<|0.001|TWO_SIDED||||||Latent growth modeling|||||||<.001
70925980|NCT04938492|141345892|SUPERIORITY||Slope|0.22|||<|0.01|TWO_SIDED||||||Latent growth modeling|||||||<.01
70925981|NCT04938492|141345893|SUPERIORITY||Slope|0.23|||>|0.05|TWO_SIDED||||||Latent growth modeling|||||||>.05
70925982|NCT02876588|141345951|SUPERIORITY||Odds Ratio (OR)|1.03||||0.6|TWO_SIDED|95.0|0.9|1.2||Random-effects logistic regression models were constructed, using RAR order sessions as the outcome, randomization group as the independent variable, and the clinician as the random intercept to account for nesting of order sessions within clinicians|Regression, Logistic|||||1.20|.90|.60
70925983|NCT02876588|141345952|SUPERIORITY||Odds Ratio (OR)|1.03||||0.68|TWO_SIDED|95.0|0.89|1.19||Random-effects logistic regression models were constructed, using RAR order sessions as the outcome, randomization group as the independent variable, the clinician as the random intercept to account for nesting of order sessions within clinicians|Regression, Logistic|||||1.19|.89|.68
70925984|NCT02876588|141345953|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
70925985|NCT02143726|141345994|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.0918|TWO_SIDED|95.0|0.23|1.33|||Log Rank|Stratified 1-sided log-rank test (stratified by ECOG performance status, prior systemic treatment for hürthle thyroid cancer, and treating site).||||1.33|0.23|0.0918
70925986|NCT02143726|141345996|SUPERIORITY||Hazard Ratio (HR)|1.62||||0.3976|TWO_SIDED|95.0|0.53|4.96|||Log Rank|||||4.96|0.53|0.3976
70925987|NCT03953508|141346030|OTHER|Analysis of covariance test|||||>|0.05||||||Threshold for significance is p\<.05|ANCOVA|||||||>.05
70925988|NCT03953508|141346031|OTHER|T-test comparing differences, the null hypothesis is that the groups are equal|||||>|0.05||||||Threshold for significance is p\<.05|t-test, 2 sided|||||||>.05
70925989|NCT03953508|141346032|OTHER|Analysis of variance test comparing average breakpoint for menthol and non-menthol smokers|||||<|0.05||||||Threshold for significance is p\<.05|ANOVA|||||||<.05
70925990|NCT03953508|141346033|OTHER|T-test|||||<|0.05||||||Threshold for significance is p\<.05|t-test, 2 sided|||||||<.05
70925991|NCT03953508|141346034|OTHER|Analysis of variance|||||>|0.05||||||Threshold for significance is p\<.05|ANOVA|||||||>.05
70925992|NCT03953508|141346035|OTHER|Analysis of variance|||||<|0.05||||||Threshold for significance is p\<.05|ANOVA|||||||<.05
70925993|NCT03953508|141346036|OTHER|T-test|||||<|0.05||||||Threshold for significance is p\<.05|t-test, 2 sided|||||||<.05
70925994|NCT03953508|141346037|OTHER|Fisher's exact test|||||>|0.05||||||Threshold for significance is p\<.05|Fisher Exact|||||||>.05
70925995|NCT03953508|141346038|OTHER|T-test|||||>|0.05||||||Threshold for significance is p\<.05|t-test, 2 sided|||||||>.05
70925996|NCT03953508|141346039|OTHER|T-test|||||>|0.05||||||Threshold for significance is p\<.05|t-test, 2 sided|||||||>.05
70925997|NCT01160211|141346063|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.0063|TWO_SIDED|95.0|0.45|0.88||Pike estimate of the treatment hazard ratio, \<1 indicates a lower risk compared with trastuzumab + AI.|Log Rank|using a two-sided stratified log-rank test (based on stratification factors)||Null hypothesis H0: λ ≥ 1 or to reject it in favor of the alternative hypothesis HA: λ \<1, where λ is the hazard ratio (HR) between Treatment Group A and Treatment Group B for progression-free survival.||0.88|0.45|0.0063
71045761|NCT02697773|141599486|SUPERIORITY||Least Square Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.22|-0.41|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.41|-1.22|<.0001
71045762|NCT02697773|141599486|SUPERIORITY||Least Square Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.29|-0.48|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.48|-1.29|<.0001
70925998|NCT01160211|141346065|SUPERIORITY||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.44|0.79||||||||0.79|0.44|
71045763|NCT02697773|141599486|SUPERIORITY||Least Square Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.46|-0.63|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.63|-1.46|<.0001
71045764|NCT02697773|141599486|SUPERIORITY||Least Square Mean Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.49|-0.66|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.66|-1.49|<.0001
71045765|NCT02697773|141599486|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.22||0.0024|TWO_SIDED|95.0|-1.12|-0.24|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.24|-1.12|0.0024
71045766|NCT02697773|141599486|SUPERIORITY||Least Square Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.22||0.0078|TWO_SIDED|95.0|-1.03|-0.16|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.16|-1.03|0.0078
71045767|NCT02697773|141599486|SUPERIORITY||Least Square Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.24||0.0002|TWO_SIDED|95.0|-1.35|-0.43|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.43|-1.35|0.0002
71045768|NCT02697773|141599486|SUPERIORITY||Least Square Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.5|-0.57|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.57|-1.50|<.0001
71045769|NCT02697773|141599486|SUPERIORITY||Least Square Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.24||0.0034|TWO_SIDED|95.0|-1.16|-0.23|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.23|-1.16|0.0034
71045770|NCT02697773|141599486|SUPERIORITY||Least Square Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.24||0.0003|TWO_SIDED|95.0|-1.33|-0.4|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.40|-1.33|0.0003
71045771|NCT02697773|141599488|SUPERIORITY||Least Square Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.22||0.0026|TWO_SIDED|95.0|-1.1|-0.23|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.23|-1.10|0.0026
70925999|NCT01160211|141346065|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.66|1.15||||||||1.15|0.66|
70926000|NCT01160211|141346065|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.51|0.92||||||||0.92|0.51|
70926001|NCT01160211|141346071|SUPERIORITY||Least square difference|-1.79|STANDARD_ERROR_OF_MEAN|2.111|||TWO_SIDED|95.0|-5.95|2.36||||||FACT-B total score||2.36|-5.95|
70926002|NCT01160211|141346071|SUPERIORITY||Least square difference|-3.9|STANDARD_ERROR_OF_MEAN|2.13|||TWO_SIDED|95.0|-8.09|0.29||||||FACT-B total score||0.29|-8.09|
70926003|NCT01160211|141346071|SUPERIORITY||Least square difference|-1.5|STANDARD_ERROR_OF_MEAN|1.739|||TWO_SIDED|95.0|-4.92|1.92||||||FACT-G total score||1.92|-4.92|
70926004|NCT01160211|141346071|SUPERIORITY||Least square difference|-3.1|STANDARD_ERROR_OF_MEAN|1.751|||TWO_SIDED|95.0|-6.55|0.34||||||FACT-G total score||0.34|-6.55|
70926005|NCT01160211|141346071|SUPERIORITY||Least square difference|-2.7|STANDARD_ERROR_OF_MEAN|1.502|||TWO_SIDED|95.0|-5.66|0.25||||||FACT-B trial outcome index (TOI)||0.25|-5.66|
70926006|NCT01160211|141346071|SUPERIORITY||Least square difference|-3.61|STANDARD_ERROR_OF_MEAN|1.512|||TWO_SIDED|95.0|-6.59|-0.64||||||FACT-B trial outcome index (TOI)||-0.64|-6.59|
70926007|NCT01160211|141346071|SUPERIORITY||Least square difference|-1.46|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-2.82|-0.11||||||Physical well-being (PWB)||-0.11|-2.82|
70926008|NCT01160211|141346071|SUPERIORITY||Least square difference|-1.54|STANDARD_ERROR_OF_MEAN|0.693|||TWO_SIDED|95.0|-2.9|-0.18||||||Physical well-being (PWB)||-0.18|-2.90|
70926009|NCT01160211|141346071|SUPERIORITY||Least square difference|0.39|STANDARD_ERROR_OF_MEAN|0.711|||TWO_SIDED|95.0|-1.01|1.79||||||Social family wellbeing (SWB)||1.79|-1.01|
70926010|NCT01160211|141346071|SUPERIORITY||Least square difference|-0.55|STANDARD_ERROR_OF_MEAN|0.715|||TWO_SIDED|95.0|-1.96|0.86||||||Social family wellbeing (SWB)||0.86|-1.96|
70926011|NCT01160211|141346071|SUPERIORITY||Least square difference|0.54|STANDARD_ERROR_OF_MEAN|0.568|||TWO_SIDED|95.0|-0.57|1.66||||||Emotional wellbeing (EWB)||1.66|-0.57|
70926012|NCT01160211|141346071|SUPERIORITY||Least square difference|0.4|STANDARD_ERROR_OF_MEAN|0.571|||TWO_SIDED|95.0|-0.72|1.53||||||Emotional wellbeing (EWB)||1.53|-0.72|
70926013|NCT01160211|141346071|SUPERIORITY||Least square difference|-0.99|STANDARD_ERROR_OF_MEAN|0.646|||TWO_SIDED|95.0|-2.26|0.28||||||Functional wellbeing (FWB)||0.28|-2.26|
70926014|NCT01160211|141346071|SUPERIORITY||Least square difference|-1.32|STANDARD_ERROR_OF_MEAN|0.649|||TWO_SIDED|95.0|-2.6|-0.04||||||Functional wellbeing (FWB)||-0.04|-2.60|
71103237|NCT02231580|141714576|SUPERIORITY_OR_OTHER||GLS mean ratio|1.059|||=|0.5661|TWO_SIDED|90.0|0.897|1.25|||MMRM|||Right hand IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.25|0.897|=0.5661
71009392|NCT00608426|141526568|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED|||||for the comparison of attended VA smoking cessation clinic between the two groups|Mixed effects logistic regression|||||||.77
71009393|NCT00608426|141526568|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||for the comparison of received VA smoking cessation medication between the two groups|Mixed effects logistic regression|||||||.002
71009394|NCT00608426|141526569|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Regression, Logistic|||||||0.13
71009395|NCT02630459|141526578|SUPERIORITY|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-1.89|||<|0.001|TWO_SIDED|95.0|-2.58|-1.2||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure||-1.20|-2.58|<0.001
71009396|NCT02630459|141526578|SUPERIORITY|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-2.31|||<|0.001|TWO_SIDED|95.0|-3.0|-1.62||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure||-1.62|-3.00|<0.001
71045772|NCT02697773|141599488|SUPERIORITY||Least Mean Square Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.22||0.0023|TWO_SIDED|95.0|-1.1|-0.24|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.24|-1.10|0.0023
71045773|NCT02697773|141599488|SUPERIORITY||Least Square Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.23||0.0002|TWO_SIDED|95.0|-1.29|-0.4|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.40|-1.29|0.0002
71045774|NCT02697773|141599488|SUPERIORITY||Least Square Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.35|-0.47|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.47|-1.35|<.0001
71045775|NCT02697773|141599488|SUPERIORITY||Least Square Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.24||0.0066|TWO_SIDED|95.0|-1.11|-0.18|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.18|-1.11|0.0066
71045776|NCT02697773|141599488|SUPERIORITY||Least Square Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.23||0.1506|TWO_SIDED|95.0|-0.79|0.12|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.12|-0.79|0.1506
71045777|NCT02697773|141599488|SUPERIORITY||Least Square Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.25||0.0021|TWO_SIDED|95.0|-1.25|-0.28|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.28|-1.25|0.0021
71045778|NCT02697773|141599488|SUPERIORITY||Least Square Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.25||0.0008|TWO_SIDED|95.0|-1.32|-0.35|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.35|-1.32|0.0008
71103238|NCT02231580|141714577|SUPERIORITY_OR_OTHER||GLS mean ratio|1.571|||=|0.0874|TWO_SIDED|90.0|1.018|2.424|||MMRM|||Left hand ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.424|1.018|=0.0874
70926015|NCT01160211|141346071|SUPERIORITY||Least square difference|-0.35|STANDARD_ERROR_OF_MEAN|0.665|||TWO_SIDED|95.0|-1.66|0.95||||||Breast cancer subscale (BCS)||0.95|-1.66|
70926016|NCT01160211|141346071|SUPERIORITY||Least square difference|-0.83|STANDARD_ERROR_OF_MEAN|0.668|||TWO_SIDED|95.0|-2.14|0.48||||||Breast cancer subscale (BCS)||0.48|-2.14|
71009397|NCT02630459|141526578|SUPERIORITY|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-1.25||||0.004|TWO_SIDED|95.0|-2.1|-0.41||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure||-0.41|-2.10|0.004
71009398|NCT02630459|141526579|SUPERIORITY||Treatment Difference|0.0|||||TWO_SIDED|95.0|-13.3|13.8|||||The 95% CI for the difference was calculated using the Newcombe hybrid score method.|Week 4: Full Administration||13.8|-13.3|
71009399|NCT02630459|141526579|SUPERIORITY||Treatment Difference|0.0|||||TWO_SIDED|95.0|-13.8|13.3|||||The 95% CI for the difference was calculated using the Newcombe hybrid score method.|Week 4: Not Full Administration||13.3|-13.8|
71009400|NCT02630459|141526579|SUPERIORITY||Treatment Difference|0.0|||||TWO_SIDED|95.0|-13.8|13.3|||||The 95% CI for the difference was calculated using the Newcombe hybrid score method.|Week 4: Discontinued Investigational Product||13.3|-13.8|
71009401|NCT02630459|141526579|SUPERIORITY||Treatment Difference|0.0|||||TWO_SIDED|95.0|-13.3|13.8|||||The 95% CI for the difference was calculated using the Newcombe hybrid score method.|Week 8: Full Administration||13.8|-13.3|
71009402|NCT02630459|141526579|SUPERIORITY||Treatment Difference|0.0|||||TWO_SIDED|95.0|-13.8|13.3|||||The 95% CI for the difference was calculated using the Newcombe hybrid score method.|Week 8: Not Full Administration||13.3|-13.8|
71009403|NCT02630459|141526579|SUPERIORITY||Treatment Difference|0.0|||||TWO_SIDED|95.0|-13.8|13.3|||||The 95% CI for the difference was calculated using the Newcombe hybrid score method.|Week 8: Discontinued Investigational Product||13.3|-13.8|
71009404|NCT02630459|141526580|SUPERIORITY||Common Odds Ratio|4.73|||<|0.001|TWO_SIDED|95.0|2.24|9.99||P-values for pairwise comparisons were nominal and obtained from the CMH test using data including placebo and corresponding erenumab dose group only.|Cochran-Mantel-Haenszel|||The common odds ratios and p-values were obtained from a Cochran-Mantel-Haenszel (CMH) test, stratified by stratification factor prior/current treatment with migraine prophylactic medication status.||9.99|2.24|<0.001
71009405|NCT02630459|141526580|SUPERIORITY||Common Odds Ratio|5.6|||<|0.001|TWO_SIDED|95.0|2.6|12.06||P-values for pairwise comparisons were nominal and obtained from the CMH test using data including placebo and corresponding erenumab dose group only.|Cochran-Mantel-Haenszel|||The common odds ratios and p-values were obtained from a CMH test, stratified by stratification factor prior/current treatment with migraine prophylactic medication status.||12.06|2.60|<0.001
71009406|NCT02630459|141526580|SUPERIORITY||Common Odds Ratio|3.21||||0.009|TWO_SIDED|95.0|1.3|7.88||P-values for pairwise comparisons were nominal and obtained from the CMH test using data including placebo and corresponding erenumab dose group only.|Cochran-Mantel-Haenszel|||The common odds ratios and p-values were obtained from a CMH test, stratified by stratification factor prior/current treatment with migraine prophylactic medication status.||7.88|1.30|0.009
71009407|NCT02630459|141526581|SUPERIORITY|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-2.04|||<|0.001|TWO_SIDED|95.0|-2.63|-1.45||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure||-1.45|-2.63|<0.001
71009408|NCT02630459|141526581|SUPERIORITY|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-2.07|||<|0.001|TWO_SIDED|95.0|-2.66|-1.49||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure||-1.49|-2.66|<0.001
71029120|NCT02777528|141565753|OTHER|Performance goal tested using Exact method calculation to estimate the 95% one-sided lower confidence level (95% LCL) on the proportion of participants with primary endpoint success. If the 95% LCL exceeded 0.60, then the null hypothesis was to be rejected and the PG was met.|95% Exact Lower Confidence Limit|0.745|||||TWO_SIDED|||||||||"Primary endpoint success was defined as the proportion of analysis-eligible participants without a primary endpoint event and with 1-Month imaging performed.~Results were tested against a performance goal (PG) of 0.60 (i.e. 60%), derived from outcomes from a systematic review of hybrid TEVAR repair literature.~Additionally, using a one-sided alpha of 0.05 and Exact Test, minimum power of 80%, the sample needed was 50 patients."||||
71009409|NCT02630459|141526581|SUPERIORITY|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-1.07||||0.004|TWO_SIDED|95.0|-1.8|-0.35||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure||-0.35|-1.80|0.004
71009410|NCT01453439|141526590|SUPERIORITY||Slope|-0.4602|STANDARD_ERROR_OF_MEAN|0.1249|<|0.01|TWO_SIDED|||||Degrees of freedom=90.9|Mixed Models Analysis|Effect of interest: time by group interaction|The estimated value describes the mean slope difference of CBT compared to SPT.|"We compared the difference in the rate of change in BDD symptom severity over time (during treatment phase) between the randomized treatment groups (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in BDD symptom severity in the CBT group will not be significantly different from the SPT group \[to be tested\]."||||<.01
71009411|NCT01453439|141526590|SUPERIORITY||Slope|-0.00984|STANDARD_ERROR_OF_MEAN|0.1038||0.62|TWO_SIDED|||||Degrees of freedom=74.7|Mixed Models Analysis|The effect of interest was the time by group interaction.|The estimated value describes the mean slope difference of CBT compared to SPT during follow-up (week 24 to week 50).|"We compared the difference in the rate of change in BDD symptom severity over time (during the follow-up phase) between the randomized treatment groups (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in BDD symptom severity during follow-up will not differ significantly between CBT and SPT treatments \[to be tested\]."||||.62
71009412|NCT01453439|141526591|SUPERIORITY|||||||0.1||||||Degrees of freedom=93.2|Mixed Models Analysis|||"We compared the change in Patient Insight over time (During Treatment phase) by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of improvement in insight in the CBT group will not be significantly different from the SPT group \[to be tested\]."||||.10
71009413|NCT01453439|141526591|SUPERIORITY|||||||0.45||||||Degrees of freedom=74.5|Mixed Models Analysis|||"We compared the change in Patient Insight over time (during the follow-up phase), by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of improvement in insight in the CBT group will not be significantly different from the SPT group during follow-up \[to be tested\]."||||.45
71045779|NCT02697773|141599488|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.25||0.0167|TWO_SIDED|95.0|-1.09|-0.11|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.11|-1.09|0.0167
71045780|NCT02697773|141599488|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.25||0.0073|TWO_SIDED|95.0|-1.17|-0.18|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.18|-1.17|0.0073
71045781|NCT02697773|141599490|SUPERIORITY||Least Square Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.23||0.0058|TWO_SIDED|95.0|-1.09|-0.18|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.18|-1.09|0.0058
71045782|NCT02697773|141599490|SUPERIORITY||Least Square Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.23||0.0002|TWO_SIDED|95.0|-1.31|-0.41|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.41|-1.31|0.0002
71045783|NCT02697773|141599490|SUPERIORITY||Least Square Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.44|-0.51|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.51|-1.44|<.0001
71103239|NCT02231580|141714577|SUPERIORITY_OR_OTHER||GLS mean ratio|1.18|||=|0.6431|TWO_SIDED|90.0|0.644|2.162|||MMRM|||Right hand ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.162|0.644|=0.6431
71103240|NCT02231580|141714577|SUPERIORITY_OR_OTHER||GLS mean ratio|1.193|||=|0.0389|TWO_SIDED|90.0|1.038|1.371|||MMRM|||Left hand ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.371|1.038|=0.0389
70926017|NCT05409183|141346082|OTHER||LS Mean of Treatment Difference|26.473|STANDARD_ERROR_OF_MEAN|9.216||0.0032|TWO_SIDED|95.0|7.847|45.099|||ANCOVA|||||45.099|7.847|0.0032
71045784|NCT02697773|141599490|SUPERIORITY||Least Square Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.56|-0.64|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.64|-1.56|<.0001
71045785|NCT02697773|141599490|SUPERIORITY||Least Square Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.24||0.0091|TWO_SIDED|95.0|-1.11|-0.16|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.16|-1.11|0.0091
71045786|NCT02697773|141599490|SUPERIORITY||Least Square Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.24||0.0668|TWO_SIDED|95.0|-0.92|0.03|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.03|-0.92|0.0668
71045787|NCT02697773|141599490|SUPERIORITY||Least Square Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.26||0.0011|TWO_SIDED|95.0|-1.36|-0.34|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.34|-1.36|0.0011
71045788|NCT02697773|141599490|SUPERIORITY||Least Square Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.26||0.0002|TWO_SIDED|95.0|-1.48|-0.46|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.46|-1.48|0.0002
71045789|NCT02697773|141599490|SUPERIORITY||Least Square Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.25||0.0059|TWO_SIDED|95.0|-1.2|-0.2|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.20|-1.20|0.0059
71045790|NCT02697773|141599490|SUPERIORITY||Least Square Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.25||0.0005|TWO_SIDED|95.0|-1.39|-0.39|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.39|-1.39|0.0005
71045791|NCT02697773|141599493|SUPERIORITY||Least Square Mean Difference|0.61|STANDARD_ERROR_OF_MEAN|1.56||0.6984|TWO_SIDED|95.0|-2.48|3.7|||ANCOVA|||Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||3.70|-2.48|0.6984
71045792|NCT02697773|141599493|SUPERIORITY||Least Square Mean Difference|-1.68|STANDARD_ERROR_OF_MEAN|1.6||0.2953|TWO_SIDED|95.0|-4.84|1.48|||ANCOVA|||Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||1.48|-4.84|0.2953
71045793|NCT02697773|141599493|SUPERIORITY||Least Square Mean Difference|-5.43|STANDARD_ERROR_OF_MEAN|4.14||0.1911|TWO_SIDED|95.0|-13.59|2.74|||ANCOVA|||Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||2.74|-13.59|0.1911
71045794|NCT02697773|141599493|SUPERIORITY||Least Square Mean Difference|-5.59|STANDARD_ERROR_OF_MEAN|4.2||0.1857|TWO_SIDED|95.0|-13.89|2.71|||ANCOVA|||Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||2.71|-13.89|0.1857
71045795|NCT02697773|141599493|SUPERIORITY||Least Square Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|4.21||0.1707|TWO_SIDED|95.0|-14.12|2.52|||ANCOVA|||Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||2.52|-14.12|0.1707
71045796|NCT02697773|141599493|SUPERIORITY||Least Square Mean Difference|-6.39|STANDARD_ERROR_OF_MEAN|4.29||0.138|TWO_SIDED|95.0|-14.85|2.07|||ANCOVA|||Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||2.07|-14.85|0.1380
71045797|NCT02697773|141599493|SUPERIORITY||Least Square Mean Difference|-3.82|STANDARD_ERROR_OF_MEAN|2.42||0.1151|TWO_SIDED|95.0|-8.58|0.94|||ANCOVA|||Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||0.94|-8.58|0.1151
70926018|NCT04806451|141346085|SUPERIORITY||LS Mean Difference|-267.775|STANDARD_ERROR_OF_MEAN|68.313||0.0002|TWO_SIDED|95.0|-403.427|-132.124|||ANCOVA|||||-132.124|-403.427|0.0002
70926019|NCT05835336|141346092|SUPERIORITY|Considering the exploratory nature of the study, a sample size of at least 0.5 (Cohen's D) for a 2-Tailed test, at alpha-0.05 with a power of 80%, was chosen to detect significant within-subject effects.|Mean Difference (Final Values)|7.45|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
70926020|NCT05835336|141346093|SUPERIORITY|Considering the exploratory nature of the study, a sample size of at least 0.5 (Cohen's D) for a 2-Tailed test, at alpha-0.05 with a power of 80%, was chosen to detect significant within-subject effects.|Mean Difference (Final Values)|3.9|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71009414|NCT01453439|141526592|SUPERIORITY|||||||0.05||||||Degrees of freedom=89.1|Mixed Models Analysis|||"We compared the change in depressive symptoms over time (During Treatment phase) by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of improvement in depressive symptoms in the CBT group will not be significantly different from the SPT group \[to be tested\]."||||.05
71045798|NCT02697773|141599493|SUPERIORITY||Least Square Mean Difference|-3.77|STANDARD_ERROR_OF_MEAN|2.41||0.1195|TWO_SIDED|95.0|-8.51|0.98|||ANCOVA|||Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||0.98|-8.51|0.1195
71045799|NCT02697773|141599504|SUPERIORITY||Odds Ratio (OR)|0.48||||0.1444|TWO_SIDED|95.0|0.18|1.29|||Regression, Logistic|||Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.29|0.18|0.1444
71045800|NCT02697773|141599504|SUPERIORITY||Odds Ratio (OR)|0.29||||0.0335|TWO_SIDED|95.0|0.09|0.91|||Regression, Logistic|||Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.91|0.09|0.0335
71045801|NCT02697773|141599505|SUPERIORITY|||||||0.0809||||||P-value was based on the log-rank test.|Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.0809
71045802|NCT02697773|141599505|SUPERIORITY|||||||0.0239||||||P-value was based on the log-rank test.|Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.0239
71045803|NCT02697773|141599506|SUPERIORITY||Odds Ratio (OR)|0.7||||0.0761|TWO_SIDED|95.0|0.48|1.04|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.04|0.48|0.0761
71045804|NCT02697773|141599506|SUPERIORITY||Odds Ratio (OR)|0.65||||0.0312|TWO_SIDED|95.0|0.44|0.96|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.96|0.44|0.0312
71045805|NCT02697773|141599506|SUPERIORITY||Odds Ratio (OR)|0.65||||0.0262|TWO_SIDED|95.0|0.45|0.95|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.95|0.45|0.0262
71045806|NCT02697773|141599506|SUPERIORITY||Odds Ratio (OR)|0.54||||0.0013|TWO_SIDED|95.0|0.37|0.79|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.79|0.37|0.0013
71045807|NCT02697773|141599506|SUPERIORITY||Odds Ratio (OR)|0.92||||0.6706|TWO_SIDED|95.0|0.64|1.33|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.33|0.64|0.6706
71045808|NCT02697773|141599506|SUPERIORITY||Odds Ratio (OR)|0.99||||0.972|TWO_SIDED|95.0|0.69|1.43|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.43|0.69|0.9720
71045809|NCT02697773|141599506|SUPERIORITY||Odds Ratio (OR)|0.89||||0.5311|TWO_SIDED|95.0|0.61|1.29|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.29|0.61|0.5311
70926021|NCT05835336|141346094|SUPERIORITY|Considering the exploratory nature of the study, a sample size of at least 0.5 (Cohen's D) for a 2-Tailed test, at alpha-0.05 with a power of 80%, was chosen to detect significant within-subject effects.|Mean Difference (Final Values)|3.55||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
70926022|NCT05835336|141346095|SUPERIORITY|Considering the exploratory nature of the study, a sample size of at least 0.5 (Cohen's D) for a 2-Tailed test, at alpha-0.05 with a power of 80%, was chosen to detect significant within-subject effects.|Mean Difference (Final Values)|5.16||||0.032|TWO_SIDED||||||t-test, 2 sided|||||||0.032
71009415|NCT01453439|141526592|SUPERIORITY|||||||0.26||||||Degrees of freedom=63.7|Mixed Models Analysis|||"We compared the change in depressive symptoms over time (during the follow-up phase), by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in depressive symptoms in the CBT group will not be significantly different from the SPT group during follow-up \[to be tested\]."||||.26
71045810|NCT02697773|141599506|SUPERIORITY||Odds Ratio (OR)|0.77||||0.1712|TWO_SIDED|95.0|0.53|1.12|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.12|0.53|0.1712
70926023|NCT05835336|141346097|SUPERIORITY|Considering the exploratory nature of the study, a sample size of at least 0.5 (Cohen's D) for a 2-Tailed test, at alpha-0.05 with a power of 80%, was chosen to detect significant within-subject effects.|Mean Difference (Final Values)|7.58||||0.035|TWO_SIDED||||||t-test, 2 sided|||||||0.035
70926024|NCT05835336|141346098|SUPERIORITY|Considering the exploratory nature of the study, a sample size of at least 0.5 (Cohen's D) for a 2-Tailed test, at alpha-0.05 with a power of 80%, was chosen to detect significant within-subject effects.|Mean Difference (Final Values)|-1.13||||0.521|TWO_SIDED||||||t-test, 2 sided|||||||.521
71045811|NCT02697773|141599506|SUPERIORITY||Odds Ratio (OR)|1.06||||0.7475|TWO_SIDED|95.0|0.73|1.54|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.54|0.73|0.7475
71045812|NCT02697773|141599506|SUPERIORITY||Odds Ratio (OR)|0.92||||0.6564|TWO_SIDED|95.0|0.63|1.33|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.33|0.63|0.6564
71045813|NCT02697773|141599508|SUPERIORITY||LS Mean Ratio|0.92|STANDARD_ERROR_OF_MEAN|0.11||0.4833|TWO_SIDED|95.0|0.73|1.16|||Negative binomial model|||Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.16|0.73|0.4833
71045814|NCT02697773|141599508|SUPERIORITY|Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|LS Mean Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.1||0.0942|TWO_SIDED|95.0|0.65|1.03|||Negative binomial model|||||1.03|0.65|0.0942
71045815|NCT02697773|141599508|SUPERIORITY||LS Mean Ratio|0.88|STANDARD_ERROR_OF_MEAN|0.12||0.3371|TWO_SIDED|95.0|0.67|1.15|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.15|0.67|0.3371
71045816|NCT02697773|141599508|SUPERIORITY||LS Mean Ratio|0.76|STANDARD_ERROR_OF_MEAN|0.11||0.0508|TWO_SIDED|95.0|0.58|1.0|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.00|0.58|0.0508
71045817|NCT02697773|141599508|SUPERIORITY||LS Mean Ratio|0.95|STANDARD_ERROR_OF_MEAN|0.14||0.728|TWO_SIDED|95.0|0.71|1.27|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.27|0.71|0.7280
71045818|NCT02697773|141599508|SUPERIORITY||LS Mean Ratio|0.87|STANDARD_ERROR_OF_MEAN|0.13||0.3244|TWO_SIDED|95.0|0.65|1.15|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.15|0.65|0.3244
71045819|NCT02697773|141599508|SUPERIORITY||LS Mean Ratio|0.91|STANDARD_ERROR_OF_MEAN|0.16||0.5681|TWO_SIDED|95.0|0.65|1.27|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.27|0.65|0.5681
71045820|NCT02697773|141599508|SUPERIORITY||LS Mean Ratio|0.77|STANDARD_ERROR_OF_MEAN|0.13||0.1387|TWO_SIDED|95.0|0.55|1.09|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.09|0.55|0.1387
71045821|NCT02697773|141599508|SUPERIORITY||LS Mean Ratio|1.06|STANDARD_ERROR_OF_MEAN|0.18||0.7275|TWO_SIDED|95.0|0.76|1.48|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.48|0.76|0.7275
71045822|NCT02697773|141599508|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.16||0.709|TWO_SIDED|95.0|0.67|1.31|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.31|0.67|0.7090
71045823|NCT02697773|141599510|SUPERIORITY||LS Mean Ratio|0.97|STANDARD_ERROR_OF_MEAN|0.25||0.9164|TWO_SIDED|95.0|0.58|1.62|||Negative binomial model|||Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.62|0.58|0.9164
70941324|NCT00985621|141383144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.27||0.018|TWO_SIDED|95.0|-1.16|-0.11|||ANCOVA|||Analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.11|-1.16|0.018
71103241|NCT02231580|141714577|SUPERIORITY_OR_OTHER||GLS mean ratio|1.138|||=|0.1641|TWO_SIDED|90.0|0.976|1.327|||MMRM|||Right hand ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.327|0.976|=0.1641
71103242|NCT02231580|141714578|SUPERIORITY_OR_OTHER||GLS mean ratio|0.93|||=|0.5668|TWO_SIDED|90.0|0.755|1.147|||MMRM|||Left hand TF variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.147|0.755|=0.5668
71103243|NCT02231580|141714578|SUPERIORITY_OR_OTHER||GLS mean ratio|0.978|||=|0.8686|TWO_SIDED|90.0|0.778|1.229|||MMRM|||Right hand TF variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.229|0.778|=0.8686
71103244|NCT02231580|141714579|SUPERIORITY_OR_OTHER||GLS mean ratio|0.879|||=|0.1244|TWO_SIDED|90.0|0.765|1.009|||MMRM|||Left hand freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.009|0.765|=0.1244
71103245|NCT02231580|141714579|SUPERIORITY_OR_OTHER||GLS mean ratio|0.919|||=|0.3535|TWO_SIDED|90.0|0.789|1.069|||MMRM|||Right hand freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.069|0.789|=0.3535
71103246|NCT02231580|141714580|SUPERIORITY_OR_OTHER||GLS mean ratio|2.163|||=|0.015|TWO_SIDED|90.0|1.295|3.614|||MMRM|||Left foot IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||3.614|1.295|=0.015
71103247|NCT02231580|141714580|SUPERIORITY_OR_OTHER||GLS mean ratio|1.274|||=|0.5136|TWO_SIDED|90.0|0.688|2.361|||MMRM|||Right foot IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.361|0.688|=0.5136
70926025|NCT04489771|141346110|SUPERIORITY|P-value, difference in percentage and associated 95% CI were calculated using Miettinen \& Nurminen method stratified by IMDC risk categories (favorable vs. intermediate or poor).|Difference in Percentage|-0.5||||0.5312|TWO_SIDED|95.0|-14.0|12.9||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Miettinen & Nurminen||Belzutifan 200 mg minus Belzutifan 120 mg|||12.9|-14.0|0.5312
71103248|NCT02231580|141714580|SUPERIORITY_OR_OTHER||GLS mean ratio|1.56|||=|0.0218|TWO_SIDED|90.0|1.139|2.137|||MMRM|||Left foot IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.137|1.139|=0.0218
71103249|NCT02231580|141714580|SUPERIORITY_OR_OTHER||GLS mean ratio|1.251|||=|0.372|TWO_SIDED|90.0|0.825|1.899|||MMRM|||Right foot IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.899|0.825|=0.3720
71103250|NCT02231580|141714581|SUPERIORITY_OR_OTHER||GLS mean ratio|1.911|||=|0.915|TWO_SIDED|90.0|1.017|3.592|||MMRM|||Left foot TD variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||3.592|1.017|=0.915
71103251|NCT02231580|141714581|SUPERIORITY_OR_OTHER||GLS mean ratio|1.687|||=|0.2745|TWO_SIDED|90.0|0.762|3.737|||MMRM|||Right foot TD variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||3.737|0.762|=0.2745
71103252|NCT02231580|141714581|SUPERIORITY_OR_OTHER||GLS mean ratio|1.598|||=|0.1148|TWO_SIDED|90.0|0.98|2.608|||MMRM|||Left foot TD duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.608|0.980|=0.1148
71103253|NCT02231580|141714581|SUPERIORITY_OR_OTHER||GLS mean ratio|1.454|||=|0.308|TWO_SIDED|90.0|0.789|2.679|||MMRM|||Right foot TD duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.679|0.789|=0.3080
71045824|NCT02697773|141599510|SUPERIORITY|Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|LS Mean Ratio|0.79|STANDARD_ERROR_OF_MEAN|0.2||0.3542|TWO_SIDED|95.0|0.47|1.31|||Negative binomial model|||||1.31|0.47|0.3542
70926026|NCT04489771|141346111|OTHER||Hazard Ratio (HR)|0.94||||0.3861|TWO_SIDED|95.0|0.63|1.4||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Log Rank|One-sided nominal p-value based on log-rank test stratified by IMDC risk group (favorable vs. intermediate or poor).|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC risk group (favorable vs. intermediate or poor).|||1.40|0.63|0.3861
70926027|NCT04489771|141346113|OTHER|One-sided nominal p-value, difference in percentage and associated 95% CIs were based on Miettinen \& Nurminen method stratified by IMDC risk group (favorable vs. intermediate or poor).|Miettinen & Nurminen method|-6.3||||0.7832|TWO_SIDED|95.0|-21.7|9.4|||Miettinen & Nurminen method|||||9.4|-21.7|0.7832
70926028|NCT04489771|141346114|OTHER||Hazard Ratio (HR)|1.11||||0.6448|TWO_SIDED|95.0|0.65|1.9||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Log Rank|One-sided nominal p-value based on log-rank test stratified by IMDC risk group (favorable vs. intermediate or poor).|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC risk group (favorable vs. intermediate or poor).|||1.90|0.65|0.6448
70926029|NCT03241459|141346119|NON_INFERIORITY|15.0% is the absolute noninferiority margin (50% of the difference in primary patency rate between IN.PACT Admiral DCB and PTA).|Difference in percentage|-3.7||||0.0029|ONE_SIDED|97.5|-11.7|||P-value is derived from one-sided Farrington-Manning test with noninferiority margin of 15% and a one-sided significance level of 0.025.|Farrington-Manning test||For subjects missing primary effectiveness endpoint status, a logistic regression model was used for multiple imputation with pre-specified baseline variables as model predictors.|The SurVeil DCB will be declared noninferior to IN.PACT Admiral DCB with respect to efficacy endpoint if the null hypothesis of inferiority is rejected at a one-sided significance level of 0.025.|||-11.7|0.0029
70926030|NCT03241459|141346120|NON_INFERIORITY|10.0% is the absolute noninferiority margin (50% of the difference in primary safety endpoint rate between IN.PACT Admiral DCB and PTA).|Difference in percentage|2.0|||<|0.0001|ONE_SIDED|97.5|-4.1|||P-value is derived from one-sided Farrington-Manning test with noninferiority margin of 10% and a one-sided significance level of 0.025.|Farrington-Manning test||For subjects missing primary safety endpoint status, a logistic regression model was used for multiple imputation with pre-specified baseline variables as model predictors.|The SurVeil DCB will be declared noninferior to IN.PACT Admiral DCB with respect to safety endpoint if the null hypothesis of inferiority is rejected at a one-sided significance level of 0.025.|||-4.1|<.0001
70926031|NCT03241459|141346121|SUPERIORITY|||||||0.579|TWO_SIDED|95.0||||P-value is derived from two-sided Fisher's exact test.|Fisher Exact|||The incidence estimates will be reported along with a p-value from a two-sided Fisher's exact test comparing the SurVeil and the IN.PACT Admiral groups.||||0.579
70926032|NCT03241459|141346122|SUPERIORITY|||||||1||||||Both arms demonstrated 100% success, therefore, Fisher's exact test does not provide a p-value, but we populated it with a p-value of 1.00 to indicate no difference between arms.|Fisher Exact|||The incidence estimates will be reported along with a two-sided Fisher's exact test comparing the SurVeil and the IN.PACT Admiral groups.||||1.00
70926033|NCT03241459|141346123|SUPERIORITY|||||||1||||||P-value is derived from two-sided Fisher's exact test.|Fisher Exact|||The incidence estimates will be reported along with a two-sided Fisher's exact test comparing the SurVeil and the IN.PACT Admiral groups.||||1.000
70926034|NCT03241459|141346124|SUPERIORITY|||||||0.494||||||P-value is derived from two-sided Fisher's exact test.|Fisher Exact|||||||0.494
70926035|NCT03241459|141346125|NON_INFERIORITY|The Farrington and Manning test for noninferiority of proportions at a one-sided significance level of 0.025.|Difference in percentage|-1.9||||0.0059|ONE_SIDED|97.5|-12.1|||P-value is derived from one-sided Farrington-Manning test with noninferiority margin of 15% and a one-sided significance level of 0.025.|Farrington-Manning test|||The objective is to assess whether the primary patency rate of subjects in the SurVeil DCB group is noninferior to that of the IN.PACT Admiral DCB group:|||-12.1|0.0059
70926036|NCT03241459|141346126|SUPERIORITY|Target Vessel Patency for SurVeil DCB vs. Target Vessel Patency for IN.PACT DCB at 12 months.||||||0.699||||||12-Month P-Value|Fisher Exact|||The main analysis of the secondary endpoints will be carried out using the ITT analysis set.||||0.699
70926037|NCT03241459|141346126|SUPERIORITY|Target Vessel Patency for SurVeil DCB vs. Target Vessel Patency for IN.PACT DCB at 24 months.||||||1||||||24-Month P-Value|Fisher Exact|||The main analysis of the secondary endpoints will be carried out using the ITT analysis set.||||1.0
70926038|NCT03241459|141346127|SUPERIORITY|||||||0.699|TWO_SIDED|95.0||||6-Month P-Value|Fisher Exact|||||||0.699
70926039|NCT03241459|141346127|SUPERIORITY|||||||0.447||||||12-Month P-Value|Fisher Exact|||||||0.447
70926040|NCT03241459|141346127|SUPERIORITY|||||||0.589||||||24-Month P-Value|Fisher Exact|||||||0.589
70926041|NCT03241459|141346128|SUPERIORITY|||||||1||||||P-Value at 6-Months|Fisher Exact|||||||1.0
70926042|NCT03241459|141346128|SUPERIORITY|||||||0.823||||||P-Value at 12-Months|Fisher Exact|||||||0.823
70926043|NCT03241459|141346128|SUPERIORITY|||||||0.454||||||P-Value at 24-Months|Fisher Exact|||||||0.454
70926044|NCT03241459|141346129|SUPERIORITY|||||||0.535||||||P-Value at 6-Months|Fisher Exact|||||||0.535
70926045|NCT03241459|141346129|SUPERIORITY|||||||0.86||||||P-Value at 12-Months|Fisher Exact|||||||0.860
70926046|NCT03241459|141346129|SUPERIORITY|||||||0.39||||||P-Value at 24-Months|Fisher Exact|||||||0.390
70926047|NCT03241459|141346130|SUPERIORITY|||||||1||||||Both arms demonstrated 0 amputations at 6 months. Fisher's Exact test does not provide a p-value, but we populated it with a p-value of 1.00 to indicate no difference between arms.|Fisher Exact|||||||1.00
70926048|NCT03241459|141346130|SUPERIORITY|||||||1||||||Both arms demonstrated 0 amputations at 12 months. Fisher's Exact test does not provide a p-value, but we populated it with a p-value of 1.00 to indicate no difference between arms.|Fisher Exact|||||||1.00
70926049|NCT03241459|141346130|SUPERIORITY|||||||1||||||P-Value at 24-Months|Fisher Exact|||||||1.0
70926050|NCT03241459|141346131|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
70926051|NCT03241459|141346131|SUPERIORITY|||||||0.472||||||P-Value at 24-Months|Fisher Exact|||||||0.472
70926052|NCT03241459|141346132|SUPERIORITY|||||||0.193||||||P-Value for change in Rutherford Classification from BL to 1-Month|Wilcoxon (Mann-Whitney)|||||||0.193
71045825|NCT02697773|141599510|SUPERIORITY||LS Mean Ratio|0.93|STANDARD_ERROR_OF_MEAN|0.28||0.8065|TWO_SIDED|95.0|0.51|1.68|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.68|0.51|0.8065
70926053|NCT03241459|141346132|SUPERIORITY|||||||0.14||||||P-Value for change in Rutherford Classification from BL to 6-Months|Wilcoxon (Mann-Whitney)|||||||0.140
70926054|NCT03241459|141346132|SUPERIORITY|||||||0.372||||||P-Value for change in Rutherford Classification from BL to 12-Months|Wilcoxon (Mann-Whitney)|||||||0.372
70926055|NCT03241459|141346132|SUPERIORITY|||||||0.104||||||P-Value for change in Rutherford Classification from BL to 24-Months|Wilcoxon (Mann-Whitney)|||||||0.104
70926056|NCT03241459|141346133|SUPERIORITY|||||||0.32||||||P-Value for change in PARC from BL to 1-Month|Wilcoxon (Mann-Whitney)|||||||0.320
70926057|NCT03241459|141346133|SUPERIORITY|||||||0.132||||||P-Value for change in PARC from BL to 6-Months|Wilcoxon (Mann-Whitney)|||||||0.132
70926058|NCT03241459|141346133|SUPERIORITY|||||||0.248||||||P-Value for change in PARC from BL to 12-Months|Wilcoxon (Mann-Whitney)|||||||0.248
70926059|NCT03241459|141346133|SUPERIORITY|||||||0.194||||||P-Value for change in PARC from BL to 24-Months|Wilcoxon (Mann-Whitney)|||||||0.194
70926060|NCT03241459|141346134|SUPERIORITY|||||||0.789||||||P-Value for Decrease in Resting Target Limb ABI ≥0.15: BL to 6-Months|Fisher Exact|||||||0.789
70926061|NCT03241459|141346134|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
70926062|NCT03241459|141346134|SUPERIORITY|||||||0.041||||||P-Value for Decrease in Resting Target Limb ABI ≥0.15: BL to 12-Months.|Fisher Exact|||||||0.041
70926063|NCT03241459|141346134|SUPERIORITY|||||||1||||||P-Value for Decrease in Resting Target Limb TBI ≥0.15: BL to 12-Months.|Fisher Exact|||||||1.0
70926064|NCT03241459|141346134|SUPERIORITY|||||||0.401||||||P-Value for Decrease in Resting Target Limb ABI ≥0.15: BL to 24-Months.|Fisher Exact|||||||0.401
70926065|NCT03241459|141346134|SUPERIORITY|||||||1||||||P-Value for Decrease in Resting Target Limb TBI ≥0.15: BL to 24-Months.|Fisher Exact|||||||1.0
70926066|NCT03241459|141346135|OTHER|||||||0.995||||||P-value for change in WIQ from BL to 1-Month: Walking Impairment Score|Wilcoxon (Mann-Whitney)|||||||0.995
70926067|NCT03241459|141346135|SUPERIORITY|||||||0.158||||||P-value for change in WIQ from BL to 1-month: Walking distance score|Wilcoxon (Mann-Whitney)|||||||0.158
70926068|NCT03241459|141346135|SUPERIORITY|||||||0.695||||||P-value for change in WIQ from BL to 1-month: Walking speed score|Wilcoxon (Mann-Whitney)|||||||0.695
70926069|NCT03241459|141346135|SUPERIORITY|||||||0.086||||||P-value for change in WIQ from BL to 1-Month: Stair Climbing Score|Wilcoxon (Mann-Whitney)|||||||0.086
70926070|NCT03241459|141346135|SUPERIORITY|||||||0.331||||||P-value for change in WIQ from BL to 12-Months: Walking Impairment Score|Wilcoxon (Mann-Whitney)|||||||0.331
70926071|NCT03241459|141346135|SUPERIORITY|||||||0.58||||||P-value for change in WIQ from BL to 12-Months: Walking Distance Score|Wilcoxon (Mann-Whitney)|||||||0.580
70926072|NCT03241459|141346135|SUPERIORITY|||||||0.563||||||P-value for change in WIQ from BL to 12-Months: Walking Speed Score|Wilcoxon (Mann-Whitney)|||||||0.563
70926073|NCT03241459|141346135|SUPERIORITY|||||||0.27||||||P-value for change in WIQ from BL to 12-Months: Stair Climbing Score|Wilcoxon (Mann-Whitney)|||||||0.270
70926074|NCT03241459|141346135|SUPERIORITY|||||||0.869||||||P-value for change in WIQ from BL to 24-Months: Walking Impairment Score|Wilcoxon (Mann-Whitney)|||||||0.869
70926075|NCT03241459|141346135|SUPERIORITY|||||||0.837||||||P-value for change in WIQ from BL to 24-Months: Walking Distance Score|Wilcoxon (Mann-Whitney)|||||||0.837
70926076|NCT03241459|141346135|SUPERIORITY|||||||0.674||||||P-value for change in WIQ for BL to 24-Months: Walking Speed Score|Wilcoxon (Mann-Whitney)|||||||0.674
70926077|NCT03241459|141346135|SUPERIORITY|||||||0.563||||||P-value for change in WIQ for BL to 24-Months: Stair Climbing Score|Wilcoxon (Mann-Whitney)|||||||0.563
70926078|NCT03241459|141346136|SUPERIORITY|||||||0.237||||||P-value for change in 6MWT from BL to 12-Months|t-test, 2 sided|||||||0.237
70926079|NCT03241459|141346136|SUPERIORITY|||||||0.04||||||P-value for change in 6MWT from BL to 24-Months|t-test, 2 sided|||||||0.040
70926080|NCT03241459|141346137|SUPERIORITY|||||||0.772||||||P-value for change in PAQ from BL to 1-Month: Physical Function Score|Wilcoxon (Mann-Whitney)|||||||0.772
70926081|NCT03241459|141346137|SUPERIORITY|||||||0.93||||||P-value for change in PAQ from BL to 1-Month: Stability Score|Wilcoxon (Mann-Whitney)|||||||0.930
70926082|NCT03241459|141346137|SUPERIORITY|||||||0.546||||||P-value for change in PAQ from BL to 1-Month: Symptom Score|Wilcoxon (Mann-Whitney)|||||||0.546
70926083|NCT03241459|141346137|SUPERIORITY|||||||0.621||||||P-value for change in PAQ from BL to 1-Month: Treatment Satisfaction Score|Wilcoxon (Mann-Whitney)|||||||0.621
70926084|NCT03241459|141346137|SUPERIORITY|||||||0.133||||||P-value for change in PAQ from BL to 1-Month: Quality of Life Score|Wilcoxon (Mann-Whitney)|||||||0.133
70926085|NCT03241459|141346137|SUPERIORITY|||||||0.592||||||P-value for change in PAQ from BL to 1-Month: Social Limitation Score|Wilcoxon (Mann-Whitney)|||||||0.592
70926086|NCT03241459|141346137|SUPERIORITY|||||||0.601||||||P-value for change in PAQ from BL to 1-Month: Summary Score|Wilcoxon (Mann-Whitney)|||||||0.601
70926087|NCT03241459|141346137|SUPERIORITY|||||||0.185||||||P-value for change in PAQ from BL to 12-Months: Physical Function Score|Wilcoxon (Mann-Whitney)|||||||0.185
70926088|NCT03241459|141346137|SUPERIORITY|||||||0.856||||||P-value for change in PAQ from BL to 12-Months: Stability Score|Wilcoxon (Mann-Whitney)|||||||0.856
70926089|NCT03241459|141346137|SUPERIORITY|||||||0.541||||||P-value for change in PAQ from BL to 12-Months: Symptom Score|Wilcoxon (Mann-Whitney)|||||||0.541
70926090|NCT03241459|141346137|SUPERIORITY|||||||0.731||||||P-value for change in PAQ from BL to 12-Months: Treatment Satisfaction Score|Wilcoxon (Mann-Whitney)|||||||0.731
70926091|NCT03241459|141346137|SUPERIORITY|||||||0.696||||||P-value for change in PAQ from BL to 12-Months: Quality of Life Score|Wilcoxon (Mann-Whitney)|||||||0.696
70926092|NCT03241459|141346137|SUPERIORITY|||||||0.716||||||P-value for change in PAQ from BL to 12-Months: Social Limitation Score|Wilcoxon (Mann-Whitney)|||||||0.716
70926093|NCT03241459|141346137|SUPERIORITY|||||||0.797||||||P-value for change in PAQ from BL to 12-Months: Summary Score|Wilcoxon (Mann-Whitney)|||||||0.797
70926094|NCT03241459|141346137|SUPERIORITY|||||||0.29||||||P-value for change in PAQ from BL to 24-Months: Physical Function Score|Wilcoxon (Mann-Whitney)|||||||0.290
70926095|NCT03241459|141346137|SUPERIORITY|||||||0.473||||||P-value for change in PAQ from BL to 24-Months: Stability Score|Wilcoxon (Mann-Whitney)|||||||0.473
70926096|NCT03241459|141346137|SUPERIORITY|||||||0.278||||||P-value for change in PAQ from BL to 24-Months: Symptom Score|Wilcoxon (Mann-Whitney)|||||||0.278
70926097|NCT03241459|141346137|SUPERIORITY|||||||0.974||||||P-value for change in PAQ from BL to 24-Months: Treatment Satisfaction Score|Wilcoxon (Mann-Whitney)|||||||0.974
70926098|NCT03241459|141346137|SUPERIORITY|||||||0.266||||||P-value for change in PAQ from BL to 24-Months: Quality of Life Score|Wilcoxon (Mann-Whitney)|||||||0.266
70926099|NCT03241459|141346137|SUPERIORITY|||||||0.656||||||P-value for change in PAQ from BL to 24-Months: Social Limitation Score|Wilcoxon (Mann-Whitney)|||||||0.656
70926100|NCT03241459|141346137|SUPERIORITY|||||||0.959||||||P-value for change in PAQ from BL to 12-Months:Summary Score|Wilcoxon (Mann-Whitney)|||||||0.959
70926101|NCT03241459|141346138|SUPERIORITY|||||||1||||||P-Value at 36-Months|Fisher Exact|||||||1.0
70926102|NCT03241459|141346138|SUPERIORITY|||||||0.903||||||P-Value at 48-Months|Fisher Exact|||||||0.903
70926103|NCT03241459|141346138|SUPERIORITY|||||||1||||||P-Value at 60-Months|Fisher Exact|||||||1.0
70926104|NCT03241459|141346139|SUPERIORITY|||||||0.913|||||||Fisher Exact|P-Value at 36-Months||||||0.913
70926105|NCT03241459|141346139|SUPERIORITY|||||||1|||||||Fisher Exact|P-Value at 48-Months||||||1.0
70926106|NCT03241459|141346139|SUPERIORITY|||||||0.839||||||P-Value at 60-Months|Fisher Exact|||||||0.839
70926107|NCT03241459|141346140|SUPERIORITY|||||||1||||||P-Value at 36-Months|Fisher Exact|||||||1.0
70926108|NCT03241459|141346140|SUPERIORITY|||||||0.5|||||||Fisher Exact|P-Value at 48-Months||||||0.5
70926109|NCT03241459|141346140|SUPERIORITY|||||||0.251|||||||Fisher Exact|P-Value at 60-Months||||||0.251
70926110|NCT03241459|141346141|SUPERIORITY|||||||0.478||||||P-Value at 36-Months|Fisher Exact|||||||0.478
70926111|NCT03241459|141346141|SUPERIORITY|||||||0.605||||||P-Value at 48-Months|Fisher Exact|||||||0.605
70926112|NCT03241459|141346141|SUPERIORITY|||||||0.345||||||P-Value at 60-Months|Fisher Exact|||||||0.345
70926113|NCT04059484|141346226|SUPERIORITY||Hazard Ratio (HR)|1.051||||0.6437|TWO_SIDED|95.0|0.789|1.4||One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.025 level.|Stratified Log-Rank test|Stratified on presence of visceral metastasis, prior treatment with CDK4/6 inhibitors and ECOG according to IRT.|Amcenestrant versus PCEM|A hierarchical testing procedure was used to ensure a strong control of the overall Type I error. Testing was then performed sequentially in order the outcome measures was reported and continued when previous outcome measure was statistically significant at one-sided 2.5% for the primary and the first secondary outcome.||1.4|0.789|0.6437
70926114|NCT02023866|141346328|OTHER|||||||0.1875|||||||Wilcoxon Signed Rank|||Section I - Current Function Null hypothesis = change from baseline is 0.||||0.1875
70926115|NCT02023866|141346328|OTHER|||||||1|||||||Wilcoxin Signed Rank|||Section II - System Specific Involvement Null hypothesis = change from baseline is 0.||||1.0000
70926116|NCT02023866|141346328|OTHER|||||||0.0781|||||||Wilcoxin Signed Rank|||Section III - Current Clinical Assessment Null hypothesis = change from baseline is 0.||||0.0781
70926117|NCT02023866|141346328|OTHER|||||||0.2941|||||||t-test, 2 sided|One-sample t-test||Section IV - Quality of Life Null hypothesis = change from baseline is 0.||||0.2941
70926118|NCT02432404|141346396|OTHER||Mean Difference (Final Values)|-0.37||||0.011|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of G. vaginalis at baseline and during Nuvaring Use (M2-M3)||||0.011
70926119|NCT02432404|141346396|OTHER||Mean Difference (Final Values)|-0.69||||0.008|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of G. vaginalis at baseline and during Nuvaring Use (M3-M6)||||0.008
70926120|NCT02432404|141346396|OTHER||Mean Difference (Final Values)|0.08||||0.662|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of L. iners at baseline and during Nuvaring Use (M2-M3)||||0.662
70926121|NCT02432404|141346396|OTHER||Mean Difference (Final Values)|0.48||||0.41|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of L. iners at baseline and during Nuvaring Use (M3-M6)||||0.41
70926122|NCT02432404|141346396|OTHER||Mean Difference (Final Values)|0.23||||0.164|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of L. crispatus at baseline and during Nuvaring Use (M2-M3)||||0.164
70926123|NCT02432404|141346396|OTHER||Mean Difference (Final Values)|0.35||||0.183|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|||Mean quantity of L. crispatus at baseline and during Nuvaring Use (M3-M6)||||0.183
70926124|NCT02432404|141346396|OTHER||Mean Difference (Final Values)|0.12||||0.506|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of L. jensenii at baseline and during Nuvaring Use (M2-M3)||||0.506
70926125|NCT02432404|141346396|OTHER||Mean Difference (Final Values)|0.38||||0.119|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of L. jensenii at baseline and during Nuvaring Use (M3-M6)||||0.119
70926126|NCT02432404|141346396|OTHER||Mean Difference (Final Values)|0.1||||0.51|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of Megasphaera at baseline and during Nuvaring Use (M2-M3)||||0.510
70926127|NCT02432404|141346396|OTHER||Mean Difference (Final Values)|-0.3||||0.168|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of Megasphaera at baseline and during Nuvaring Use (M3-M6)||||0.168
70926128|NCT02432404|141346396|OTHER||Mean Difference (Final Values)|0.07||||0.454|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of BVAB2 at baseline and during Nuvaring Use (M2-M3)||||0.454
70926129|NCT02432404|141346396|OTHER||Mean Difference (Final Values)|-0.1||||0.471|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of BVAB2 at baseline and during Nuvaring Use (M3-M6)||||0.471
70926130|NCT05851573|141346417|OTHER||||||<|0.05|||||||t-test, 2 sided|df = 9||||||< .05
70926131|NCT05851573|141346418|OTHER||||||=|0.775|||||||t-test, 2 sided|df = 9||||||= .775
70926132|NCT05851573|141346419|OTHER||||||=|0.444|||||||t-test, 2 sided|df = 10||||||= .444
70926133|NCT05851573|141346420|OTHER|||||||0.959|||||||t-test, 2 sided|df = 9||||||.959
70926134|NCT05851573|141346421|OTHER|||||||0.068|||||||t-test, 2 sided|df = 9||||||.068
70926135|NCT05851573|141346422|OTHER||||||=|0.119|||||||t-test, 2 sided|df = 10||||||= .119
70926136|NCT05851573|141346423|OTHER||||||=|0.258|||||||t-test, 2 sided|df = 10||||||= .258
70926137|NCT05851573|141346424|OTHER||||||=|0.593|||||||t-test, 2 sided|df = 10||||||= .593
70926138|NCT04473222|141346465|SUPERIORITY||Odds Ratio, log|-0.15||||0.026|TWO_SIDED||||||t-test, 2 sided||The logit represents the difference in log odds per 1-week change in time for the intervention group relative to enhanced usual care.|||||.026
70926139|NCT04473222|141346466|SUPERIORITY||Odds Ratio, log|-0.2||||0.032|TWO_SIDED||||||t-test, 2 sided||The logit represents the difference in log odds per 1-week change in time for the intervention group relative to enhanced usual care.|||||0.032
70926140|NCT04473222|141346467|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.009||0.01|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||.010
70926141|NCT04473222|141346468|SUPERIORITY||Slope|0.009|STANDARD_ERROR_OF_MEAN|0.009||0.161|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.161
70926142|NCT04473222|141346469|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.01||0.006|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.006
70926143|NCT04473222|141346470|SUPERIORITY||Slope|0.07|STANDARD_ERROR_OF_MEAN|0.04||0.045|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.045
70926144|NCT04473222|141346471|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.11||0.685|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.685
71045826|NCT02697773|141599510|SUPERIORITY||LS Mean Ratio|0.66|STANDARD_ERROR_OF_MEAN|0.2||0.1752|TWO_SIDED|95.0|0.36|1.2|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.20|0.36|0.1752
71045827|NCT02697773|141599510|SUPERIORITY||LS Mean Ratio|0.91|STANDARD_ERROR_OF_MEAN|0.3||0.7837|TWO_SIDED|95.0|0.48|1.73|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.73|0.48|0.7837
71045828|NCT02697773|141599510|SUPERIORITY||LS Mean Ratio|0.81|STANDARD_ERROR_OF_MEAN|0.26||0.5062|TWO_SIDED|95.0|0.43|1.52|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.52|0.43|0.5062
71045829|NCT02697773|141599510|SUPERIORITY||LS Mean Ratio|0.85|STANDARD_ERROR_OF_MEAN|0.33||0.6821|TWO_SIDED|95.0|0.4|1.82|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.82|0.40|0.6821
71045830|NCT02697773|141599510|SUPERIORITY||LS Mean Ratio|0.77|STANDARD_ERROR_OF_MEAN|0.3||0.5032|TWO_SIDED|95.0|0.36|1.65|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.65|0.36|0.5032
71045831|NCT02697773|141599510|SUPERIORITY||LS Mean Ratio|1.24|STANDARD_ERROR_OF_MEAN|0.47||0.5796|TWO_SIDED|95.0|0.58|2.61|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||2.61|0.58|0.5796
71045832|NCT02697773|141599510|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.36||0.8725|TWO_SIDED|95.0|0.44|2.0|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||2.00|0.44|0.8725
71045833|NCT02149121|141599538|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|97.07|||||TWO_SIDED|90.0|88.08|106.99|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using analysis of covariance (ANCOVA) model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||106.99|88.08|
71045834|NCT02149121|141599538|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|94.18|||||TWO_SIDED|90.0|85.4|103.86|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||103.86|85.40|
71045835|NCT02149121|141599538|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|103.07|||||TWO_SIDED|90.0|93.32|113.85|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||113.85|93.32|
71045836|NCT02149121|141599539|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|95.81|||||TWO_SIDED|90.0|87.39|105.04|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||105.04|87.39|
70926145|NCT04473222|141346472|SUPERIORITY||Slope|0.42|STANDARD_ERROR_OF_MEAN|1.22||0.734|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.734
70926146|NCT04473222|141346473|SUPERIORITY||Slope|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.019|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.019
70926147|NCT04473222|141346474|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.776|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.776
70926148|NCT04636528|141346475|EQUIVALENCE|A minimal detectable difference of 11.2 points was selected based on the psychometric properties of the scale. Considering a power of 80%, a 2-sided 0.05 significance level, and a 10% dropout rate, 82 patients would be necessary to detect an 11.2-point difference between the 2 groups.|Median Difference (Net)|-1.8||||0.75|TWO_SIDED|95.0|-13.5|9.8||The threshold for statistical significance was set at 0.05.|quantile mixed-effects model|a robust method on the medians||||9.8|-13.5|0.75
70926149|NCT04636528|141346475|EQUIVALENCE||Odds Ratio (OR)|0.84||||0.71|TWO_SIDED|95.0|0.32|2.16||The threshold for statistical significance was set at 0.05.|Regression, Logistic|||||2.16|0.32|0.71
70926150|NCT04636528|141346476|EQUIVALENCE||Median Difference (Net)|-0.6||||0.12|TWO_SIDED|95.0|-1.4|-0.2||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|a robust method on the medians||||-0.2|-1.4|0.12
70926151|NCT04636528|141346477|EQUIVALENCE||Median Difference (Net)|-2.2||||0.89|TWO_SIDED|95.0|-34.6|30.2||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|||||30.2|-34.6|0.89
70926152|NCT04636528|141346478|EQUIVALENCE||Median Difference (Net)|-0.3||||0.51|TWO_SIDED|95.0|-1.0|0.5|||Quantile mixed-effects model|a robust method on the medians||||0.5|-1.0|0.51
70926153|NCT04636528|141346479|EQUIVALENCE||Median Difference (Final Values)|2.0|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was set at 0.05.|t-test, 2 sided|||||||<0.001
70926154|NCT04636528|141346480|EQUIVALENCE||Median Difference (Net)|-1.1|||<|0.001|TWO_SIDED|95.0|-1.5|0.6||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|a robust method on the medians||||0.6|-1.5|<.001
70926155|NCT04636528|141346481|EQUIVALENCE||Median Difference (Net)|-0.9|||<|0.001|TWO_SIDED|95.0|-1.4|-0.5||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|a robust method on the medians||||-0.5|-1.4|<.001
70926156|NCT04636528|141346482|EQUIVALENCE||Median Difference (Net)|-0.5||||0.27|TWO_SIDED|95.0|-1.3|0.4||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|A robust method on the medians.||||0.4|-1.3|.27
70926157|NCT04636528|141346483|EQUIVALENCE||Difference in proportions|11.8||||0.14|TWO_SIDED||||||Chi-squared|||||||0.14
70926158|NCT04636528|141346484|EQUIVALENCE||Mean Difference (Final Values)|12.7|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
70926159|NCT04636528|141346485|EQUIVALENCE||Mean Difference (Final Values)|67.7||||0.36|TWO_SIDED|||||The threshold for statistical significance was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.36
70926160|NCT04636528|141346486|EQUIVALENCE||Mean Difference (Final Values)|1.62|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
70926161|NCT06321809|141346488|SUPERIORITY|||||||0.24|||||||Wilcoxon (Mann-Whitney)|A significance level of p\<0.05 was used for all analyses.||total scale score comparison||||0.24
70926162|NCT06321809|141346488|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|A significance level of p\<0.05 was used for all analyses||total scale score comparison||||0.001
70926163|NCT06321809|141346488|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|A significance level of p\<0.05 was used for all analyses||total scale score comparison||||0.03
70926164|NCT06321809|141346488|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|A significance level of p\<0.05 was used for all analyses||total scale score comparison||||0.003
70926165|NCT06321809|141346489|SUPERIORITY|||||||0.08|||||||Kruskal-Wallis|A significance level of p\<0.05 was used for all analyses||Weight comparison||||0.08
70926166|NCT06321809|141346490|SUPERIORITY|||||||0.13|||||||Kruskal-Wallis|A significance level of p\<0.05 was used for all analyses||BMI Comparison||||0.13
70926167|NCT06321809|141346491|SUPERIORITY|||||||0.63|||||||Kruskal-Wallis|A significance level of p\<0.05 was used for all analyses||Waist Circumference Comparison||||0.63
70926168|NCT06321809|141346492|SUPERIORITY|||||||0.89|||||||Kruskal-Wallis|A significance level of p\<0.05 was used for all analyses||LDL Cholesterol Comparison||||0.89
70926169|NCT01369355|141346503|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.||||||0.040
70926170|NCT01369355|141346503|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.||||||0.005
70926171|NCT01369355|141346504|SUPERIORITY_OR_OTHER_LEGACY|||||||0.033||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.||||||0.033
70926172|NCT01369355|141346504|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.||||||0.018
70926173|NCT01369355|141346505|SUPERIORITY_OR_OTHER_LEGACY|||||||0.189||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by ustekinumab induction dose and the induction study.||||||0.189
70926174|NCT01369355|141346505|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by ustekinumab induction dose and the induction study.||||||0.007
70926175|NCT01369355|141346506|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.||||||0.035
70926176|NCT01369355|141346506|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.||||||0.004
70926177|NCT01369355|141346507|SUPERIORITY_OR_OTHER_LEGACY|||||||0.14||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2 sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission status at Week 0 and ustekinumab induction dose.||||||0.140
70926178|NCT01369355|141346507|SUPERIORITY_OR_OTHER_LEGACY|||||||0.102||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2 sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission status at Week 0 and ustekinumab induction dose.||||||0.102
70926179|NCT03131154|141346516|OTHER||Hazard Ratio (HR)|1.129|||||TWO_SIDED|95.0|0.643|1.982|||||Cox proportional hazards model|||1.982|0.643|
70926180|NCT03131154|141346517|OTHER||Hazard Ratio (HR)|2.619|||||TWO_SIDED|95.0|0.989|6.939|||||Cox proportional hazards model|||6.939|0.989|
70926181|NCT06424236|141346518|SUPERIORITY||Least square (LS) mean|-0.1166|STANDARD_DEVIATION|0.29505||0.0117|TWO_SIDED|95.0|-0.206|-0.0272|||Mixed Model for Repeated Measures (MMRM)|||Week 52: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline Composite \[11C\] PiB-PET SUVR score as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||-0.0272|-0.2060|0.0117
70926182|NCT06424236|141346518|OTHER||LS mean|-0.4648|STANDARD_DEVIATION|0.46591|<|0.0001|TWO_SIDED|95.0|-0.5971|-0.3326|||MMRM|||Week 104: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline Composite \[11C\] PiB-PET SUVR score as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||-0.3326|-0.5971|<0.0001
70926183|NCT06424236|141346518|OTHER||LS mean|-0.7062|STANDARD_DEVIATION|0.43787|<|0.0001|TWO_SIDED|95.0|-0.8821|-0.5303|||MMRM|||Week 156: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline Composite \[11C\] PiB-PET SUVR score as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||-0.5303|-0.8821|<0.0001
70926184|NCT06424236|141346519|SUPERIORITY|Recurrent progression was defined as any progression which was either the first increase in CDR-SB above baseline or any progression above the highest preceding post-baseline value identified as a progression, where progression above the preceding value must be observed at 2 consecutive measurements unless the progression occurs at the last measurement.|Hazard Ratio (HR)|1.32||||0.4535|TWO_SIDED|95.0|0.64|2.7|||Regression, Cox|||The time to recurrent progression in CDR - sum of boxes. Baseline Asymptomatic Participants: Estimate and confidence interval was based on the Cox proportional hazards regression model including treatment and baseline estimated years to symptom onset as fixed effects. The OLE gantenerumab mITT analysis set included all participants in the OLE who met mITT criteria using OLE baseline as the baseline reference point.||2.70|0.64|0.4535
70926185|NCT06424236|141346519|OTHER|Recurrent progression was defined as any progression which was either the first increase in CDR-SB above baseline or any progression above the highest preceding post-baseline value identified as a progression, where progression above the preceding value must be observed at 2 consecutive measurements unless the progression occurs at the last measurement.|Hazard Ratio (HR)|1.18||||0.4848|TWO_SIDED|95.0|0.74|1.86|||Regression, Cox|||The time to recurrent progression in CDR - sum of boxes. Baseline Symptomatic Participants: Estimate and confidence interval was based on the Cox proportional hazards regression model including treatment and baseline estimated years to symptom onset as fixed effects. The OLE gantenerumab mITT analysis set included all participants in the OLE who met mITT criteria using OLE baseline as the baseline reference point.||1.86|0.74|0.4848
70926186|NCT06424236|141346520|OTHER||Hazard Ratio (HR)|0.93||||0.8855|TWO_SIDED|95.0|0.33|2.58|||Regression, Cox|||Time to first progression in CDR-Global score. Baseline Asymptomatic Participants: Estimate and confidence interval was based on Cox proportional hazards regression model including treatment and baseline estimated years to symptom onset as fixed effects. Time to first progression was defined as time from baseline to first visit where CDR-Global Score was greater than baseline value, where progression must be observed at 2 consecutive measurements unless progression occurs at last measurement.||2.58|0.33|0.8855
71077844|NCT02913105|141664396|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.9453|TWO_SIDED|90.0|0.97|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||1.02|0.97|0.9453
70926187|NCT06424236|141346520|OTHER||Hazard Ratio (HR)|0.72||||0.4497|TWO_SIDED|95.0|0.3|1.69|||Regression, Cox|||Time to first progression in CDR-Global score. Baseline Symptomatic Participants: Estimate and confidence interval was based on Cox proportional hazards regression model including treatment and baseline estimated years to symptom onset as fixed effects. Time to first progression was defined as time from baseline to first visit where CDR-Global Score was greater than baseline value, where progression must be observed at 2 consecutive measurements unless progression occurs at last measurement.||1.69|0.30|0.4497
70926188|NCT06424236|141346521|SUPERIORITY||LS mean|-0.06|STANDARD_ERROR_OF_MEAN|0.2||0.76|TWO_SIDED|95.0|-0.46|0.33|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Asymptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with compound symmetry covariance matrix.||0.33|-0.46|0.760
70926189|NCT06424236|141346521|OTHER||LS mean|-1.21|STANDARD_ERROR_OF_MEAN|0.715||0.093|TWO_SIDED|95.0|-2.63|0.2|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Symptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.20|-2.63|0.093
70926190|NCT06424236|141346522|OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.22||0.989|TWO_SIDED|95.0|-0.43|0.44|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Asymptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.44|-0.43|0.989
70926191|NCT06424236|141346522|OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.533||0.714|TWO_SIDED|95.0|-0.86|1.25|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Symptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||1.25|-0.86|0.714
70926192|NCT06424236|141346523|OTHER||LS mean|-0.03|STANDARD_ERROR_OF_MEAN|0.077||0.738|TWO_SIDED|95.0|-0.18|0.13|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Asymptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.13|-0.18|0.738
70926193|NCT06424236|141346523|OTHER||LS mean|0.19|STANDARD_ERROR_OF_MEAN|0.222||0.395|TWO_SIDED|95.0|-0.28|0.66|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Symptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.66|-0.28|0.395
70926194|NCT06424236|141346524|OTHER||LS mean|-2.176|STANDARD_DEVIATION|2.89551|<|0.0001|TWO_SIDED|95.0|-2.9469|-1.4051|||MMRM|||Week 56: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline CSF pTau181 as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||-1.4051|-2.9469|<0.0001
70926195|NCT06424236|141346524|OTHER||LS mean|-4.8434|STANDARD_DEVIATION|3.78771|<|0.0001|TWO_SIDED|95.0|-5.8609|-3.826|||MMRM|||Week 104: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline CSF pTau181 as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||-3.8260|-5.8609|<0.0001
70926196|NCT06424236|141346524|OTHER||LS mean|-5.762|STANDARD_DEVIATION|3.31129|<|0.0001|TWO_SIDED|95.0|-6.9679|-4.5561|||MMRM|||Week 156: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline CSF pTau181 as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||-4.5561|-6.9679|<0.0001
70926197|NCT06424236|141346525|OTHER||LS mean|0.04|STANDARD_ERROR_OF_MEAN|0.022||0.055|TWO_SIDED|95.0|0.0|0.09|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Asymptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with variance components covariance matrix.||0.09|0.00|0.055
70926198|NCT06424236|141346525|OTHER||LS mean|0.04|STANDARD_ERROR_OF_MEAN|0.034||0.188|TWO_SIDED|95.0|-0.02|0.11|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Symptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.11|-0.02|0.188
71009416|NCT01453439|141526593|SUPERIORITY|||||||0.04||||||Degrees of freedom=91.4|Mixed Models Analysis|||"We compared the change in Quality of life satisfaction over time (During treatment phase) by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in Quality of life satisfaction severity in the CBT group will not be significantly different from the SPT group \[to be tested\]."||||.04
70926199|NCT06424236|141346526|OTHER||LS mean|0.0067|STANDARD_DEVIATION|0.0124||0.0001|TWO_SIDED|95.0|0.0034|0.01|||MMRM|||Week 52: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline CSF Amyloid Beta1-42/40 score as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||0.0100|0.0034|0.0001
70926200|NCT06424236|141346526|OTHER||LS mean|0.0251|STANDARD_DEVIATION|0.02262|<|0.0001|TWO_SIDED|95.0|0.0189|0.0312|||MMRM|||Week 104: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline CSF Amyloid Beta1-42/40 score as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||0.0312|0.0189|<0.0001
70926201|NCT06424236|141346526|OTHER||LS mean|0.0357|STANDARD_DEVIATION|0.02467|<|0.0001|TWO_SIDED|95.0|0.0266|0.0447|||MMRM|||Week 156: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline CSF Amyloid Beta1-42/40 score as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||0.0447|0.0266|<0.0001
70926202|NCT06424236|141346527|OTHER||LS mean|0.04|STANDARD_ERROR_OF_MEAN|0.081||0.644|TWO_SIDED|95.0|-0.12|0.2|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Asymptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.20|-0.12|0.644
70941325|NCT00985621|141383144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.28||0.7|TWO_SIDED|95.0|-0.43|0.65|||ANCOVA|||Analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.65|-0.43|0.700
71009417|NCT01453439|141526593|SUPERIORITY|||||||0.82||||||Degrees of freedom=74.7|Mixed Models Analysis|||"We compared the change in the quality of life satisfaction over time (during the follow-up phase), by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in the quality of life satisfaction in the CBT group will not be significantly different from the SPT group during follow-up \[to be tested\]."||||.82
71009418|NCT01453439|141526594|SUPERIORITY||Mean Difference (Net)|0.7937|STANDARD_ERROR_OF_MEAN|0.3007||0.0095|TWO_SIDED|||||Effect of interest: Treatment main effect, two-sided alpha = 0.05 effect adjusted for site effects, time effects, and interactions|ANOVA|repeated measures 3-way ANOVA (treatment type, site, time (repeated)) Effect of interest: main effect of treatment: F(num df=1, den df=112) = 5.17|Least Squares Means difference|Null hypothesis: There is no significant different in the perceived credibility of CBT and SPT.||||0.0095
71009419|NCT01453439|141526598|SUPERIORITY|||||||0.3||||||Degrees of freedom=88.0|Mixed Models Analysis|||"We compared the change in social functioning over time (During Treatment phase) by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts, and slopes as random effects per person.~Null hypothesis: The rate of improvement in social functioning in the CBT group will not be significantly different from the SPT group \[to be tested\]."||||.30
71009420|NCT01453439|141526598|SUPERIORITY|||||||0.85||||||Degrees of freedom=74.5|Mixed Models Analysis|||"We compared the change in social functioning over time (during the follow-up phase), by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of improvement in social functioning CBT group will not be significantly different from the SPT group during follow-up \[to be tested\]."||||.85
71009421|NCT01453439|141526599|SUPERIORITY||Mean Difference (Net)|1.5867|STANDARD_ERROR_OF_MEAN|0.6882||0.0235|TWO_SIDED|||||a priori significance level: 2-sided alpha = 0.05 effect adjusted for site effects, time effects, and interactions|ANOVA|repeated measures 3-way ANOVA (treatment type, site, time (repeated)) Effect of interest: main effect of treatment - F(num def=1,den df=79.9) = 15.55|Least Squares Means difference|Null hypothesis: There is no significant difference in treatment satisfaction between patients with BDD assigned to CBT vs. SPT.||||0.0235
71009422|NCT01453439|141526600|SUPERIORITY||Median Difference (Net)|9.439|STANDARD_ERROR_OF_MEAN|3.4259||0.0069|TWO_SIDED|||||a priori significance level: 2-sided alpha=0.05 effect adjusted for site effects, time effects, and interactions|ANOVA|repeated measures 3-way ANOVA (treatment group, site, time (repeated)) effect of interest: main effect of treatment: F(num df=1, den df=110) = 7.59|Least Squares Mean difference|Null hypotheses: There is no significant difference in patient expectancy of improvement between BDD patients assigned to CBT vs. SPT.||||0.0069
71009423|NCT01014442|141526601|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|1.305||||0.2649|TWO_SIDED|95.0|-0.83|4.25|||Wilcoxon rank sum test|||Cmax of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||4.2500|-0.8300|0.2649
71009424|NCT01014442|141526601|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|11.405||||0.3113|TWO_SIDED|95.0|-10.2|42.78|||Wilcoxon rank sum test|||Cmax of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||42.7800|-10.2000|0.3113
71009425|NCT01014442|141526601|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.305||||0.2953|TWO_SIDED|95.0|-0.81|0.19|||Wilcoxon rank sum test|||Cmax of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.1900|-0.8100|0.2953
71009426|NCT01014442|141526602|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-1.29||||0.1308|TWO_SIDED|95.0|-2.99|0.41|||Wilcoxon rank sum test|||Cmax of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.4100|-2.9900|0.1308
71009427|NCT01014442|141526602|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-10.845||||0.4886|TWO_SIDED|95.0|-31.5|20.79|||Wilcoxon rank sum test|||Cmax of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||20.7900|-31.5000|0.4886
71009428|NCT01014442|141526602|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.2||||0.2218|TWO_SIDED|95.0|-0.6|0.19|||Wilcoxon rank sum test|||Cmax of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.1900|-0.6000|0.2218
71009429|NCT01014442|141526603|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-1.87||||0.0886|TWO_SIDED|95.0|-3.79|0.28|||Wilcoxon rank sum test|||Cmax of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.2800|-3.7900|0.0886
71009430|NCT01014442|141526603|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-30.76||||0.022|TWO_SIDED|95.0|-54.97|-6.36|||Wilcoxon rank sum test|||Cmax of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-6.3600|-54.9700|0.0220
71009431|NCT01014442|141526603|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.56||||0.0008|TWO_SIDED|95.0|-1.02|-0.27|||Wilcoxon rank sum test|||Cmax of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.2700|-1.0200|0.0008
71009432|NCT01014442|141526604|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|3.945||||0.0318|TWO_SIDED|95.0|0.25|8.23|||Wilcoxon rank sum test|||Cmax of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||8.2300|0.2500|0.0318
71009433|NCT01014442|141526604|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-7.59||||0.7144|TWO_SIDED|95.0|-51.19|30.7|||Wilcoxon rank sum test|||Cmax of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||30.7000|-51.1900|0.7144
71009434|NCT01014442|141526604|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.27||||0.393|TWO_SIDED|95.0|-0.31|0.88|||Wilcoxon rank sum test|||Cmax of AcMPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.8800|-0.3100|0.3930
71009435|NCT01014442|141526605|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|17.08||||0.3002|TWO_SIDED|95.0|-16.5|74.32|||Wilcoxon rank sum test|||Cmax of Free MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||74.3200|-16.5000|0.3002
71009436|NCT01014442|141526606|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-25.24||||0.0334|TWO_SIDED|95.0|-53.25|-2.29|||Wilcoxon rank sum test|||Cmax of Free MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-2.2900|-53.2500|0.0334
71009437|NCT01014442|141526607|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-23.805||||0.1151|TWO_SIDED|95.0|-52.27|5.97|||Wilcoxon rank sum test|||Cmax of Free MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||5.9700|-52.2700|0.1151
71009438|NCT01014442|141526608|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-15.63||||0.5974|TWO_SIDED|95.0|-63.88|30.56|||Wilcoxon rank sum test|||Cmax of Free MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||30.5600|-63.8800|0.5974
71009439|NCT01014442|141526609|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0005||||0.5466|TWO_SIDED|95.0|-0.00103|0.00259|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00259|-0.00103|0.5466
71009440|NCT01014442|141526609|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.00728||||0.3223|TWO_SIDED|95.0|-0.00707|0.03161|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.03161|-0.00707|0.3223
71009441|NCT01014442|141526609|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00026||||0.2108|TWO_SIDED|95.0|-0.0007|0.00012|||Wilcoxon rank sum test|||Dose-Normalized Cmax of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00012|-0.00070|0.2108
71009442|NCT01014442|141526609|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0000112||||0.4334|TWO_SIDED|95.0|-0.000014|0.0000462|||Wilcoxon rank sum test|||Dose-Normalized Cmax of Free MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called a Hodges-Lehmann estimator.||0.0000462|-0.0000140|0.4334
71009443|NCT01014442|141526610|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00081||||0.1511|TWO_SIDED|95.0|-0.00216|0.0003|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00030|-0.00216|0.1511
70926203|NCT06424236|141346527|OTHER||LS mean|0.04|STANDARD_ERROR_OF_MEAN|0.111||0.745|TWO_SIDED|95.0|-0.18|0.26|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Symptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.26|-0.18|0.745
70926204|NCT05603143|141346537|OTHER|||||||0.3161|||||||Log Rank|||||||0.3161
70926205|NCT05603143|141346541|OTHER|||||||0.3219|||||||Log Rank|||||||0.3219
70926206|NCT05603143|141346542|OTHER||Hazard Ratio (HR)|1.496||||0.6568|TWO_SIDED|95.0|0.25|8.952|||Log Rank||Hazard ratio and two-sided 95% CI for hazard ratio were estimated using the Cox regression.|||8.952|0.250|0.6568
70926207|NCT05603143|141346543|OTHER||Hazard Ratio (HR)|2.99||||0.319|TWO_SIDED|95.0|0.311|28.74|||Log Rank||Hazard ratio and two-sided 95% CI for hazard ratio were estimated using the Cox regression.|||28.740|0.311|0.3190
70926208|NCT05603143|141346544|OTHER|||||||0.3161|||||||Log Rank|||||||0.3161
70926209|NCT05603143|141346545|OTHER||Hazard Ratio (HR)|1.425||||0.0859|TWO_SIDED|95.0|0.961|2.112||P-value was based on stratified Log-rank test with randomization stratification factors as the strata.|Log Rank||Hazard ratio and two-sided 95% CI for hazard ratio were estimated using the Cox regression with randomization stratification factors as covariates.|||2.112|0.961|0.0859
70926210|NCT05603143|141346546|OTHER||Treatment Difference (vs Placebo)|-0.58|||<|0.0001|TWO_SIDED|95.0|-0.83|-0.33|||MMRM||Least-squares mean (SE), 95% CI and P value were from MMRM with baseline viral load and randomization strata as covariates.|||-0.33|-0.83|< 0.0001
70926211|NCT02683447|141346592|OTHER|Correlation||||||0.039||||||P \< 0.05 is considered statistically significant.|Pearson correlation|||||||0.039
70926212|NCT02683447|141346593|OTHER|Correlation|||||<|0.01||||||P \< 0.05 is considered statically significant.|Pearson correlation|||ACLS correct score||||<0.01
70926213|NCT02683447|141346593|OTHER|Correlation||||||0.322||||||P \< 0.05 is considered statically significant.|Pearson correlation|||ACLS risk score||||0.322
70926214|NCT03115476|141346600|OTHER||Hazard Ratio (HR)|1.43||||0.43|TWO_SIDED|95.0|0.61|3.9|||likelihood ratio test|||Relative difference between groups (ingenol disoxate vs vehicle) expressed as hazard ratio||3.9|0.61|0.43
70926215|NCT03115476|141346601|OTHER||Hazard Ratio (HR)|1.99|||<|0.01|TWO_SIDED|95.0|1.17|3.62|||likelihood ratio test|||relative difference between treatment groups (ingenol disoxate gel vs vehicle) expressed as hazard ratio||3.62|1.17|<0.01
71045837|NCT02149121|141599539|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|89.89|||||TWO_SIDED|90.0|81.85|98.72|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||98.72|81.85|
70926216|NCT03976362|141346637|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.004|TWO_SIDED|95.0|0.63|0.93||One-sided p-value based on log-rank test stratified by Eastern Cooperative Cancer Group (ECOG) at pre-randomization visit, response at randomization and baseline PD-L1 status.|Log Rank||Based on Cox regression model with Efron's method of tie handling and with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.|||0.93|0.63|0.0040
71045838|NCT02149121|141599539|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|106.58|||||TWO_SIDED|90.0|97.03|117.08|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||117.08|97.03|
71045839|NCT02149121|141599540|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|94.92|||||TWO_SIDED|90.0|89.61|100.55|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||100.55|89.61|
71045840|NCT02149121|141599540|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|89.0|||||TWO_SIDED|90.0|84.01|94.28|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||94.28|84.01|
71045841|NCT02149121|141599540|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|106.66|||||TWO_SIDED|90.0|100.56|113.13|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||113.13|100.56|
71045842|NCT02149121|141599541|EQUIVALENCE|Therapeutic equivalence was to be concluded if the 90% CI for the treatment difference in the change from baseline of DAS28 (CRP) at Week 24 was entirely within the equivalence margin of ±0.50.|Mean Difference (Final Values)|-0.01|||||TWO_SIDED|90.0|-0.22|0.2|||||Adjusted least squares means and standard error, estimate of treatment difference \[CT-P10 - (Rituxan + MabThera)\] and 2-sided 90% confidence interval calculated from the ANCOVA model.|Primary efficacy analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, study part, interaction of treatment group with study part, prior anti TNF alpha blocker status at baseline (intolerance case versus inadequate response), and RF or anti-CCP status fitted as covariates.||0.20|-0.22|
70926217|NCT03976362|141346638|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.5481|TWO_SIDED|95.0|0.83|1.24||One-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.|Log Rank||Based on Cox regression model with Efron's method of tie handling and with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.|||1.24|0.83|0.5481
70926218|NCT03976362|141346641|OTHER||Difference in LS Means|0.37||||0.8238|TWO_SIDED|95.0|-2.91|3.66||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||3.66|-2.91|0.8238
71009444|NCT01014442|141526610|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00695||||0.4131|TWO_SIDED|95.0|-0.0205|0.01103|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.01103|-0.02050|0.4131
71103254|NCT02231580|141714582|SUPERIORITY_OR_OTHER||GLS mean ratio|2.272|||=|0.0079|TWO_SIDED|90.0|1.381|3.737|||MMRM|||Left foot IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||3.737|1.381|=0.0079
71009445|NCT01014442|141526610|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00017||||0.2677|TWO_SIDED|95.0|-0.00046|0.00013|||Wilcoxon rank sum test|||Dose-Normalized Cmax of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00013|-0.00046|0.2677
71009446|NCT01014442|141526610|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0000185||||0.0173|TWO_SIDED|95.0|-0.0000394|-0.000005|||Wilcoxon rank sum test|||Dose-Normalized Cmax of Free MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.0000050|-0.0000394|0.0173
71009447|NCT01014442|141526611|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00063||||0.3784|TWO_SIDED|95.0|-0.0023|0.00084|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00084|-0.00230|0.3784
71009448|NCT01014442|141526611|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.01602||||0.0942|TWO_SIDED|95.0|-0.03229|0.00297|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00297|-0.03229|0.0942
71009449|NCT01014442|141526611|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00037||||0.0032|TWO_SIDED|95.0|-0.00062|-0.00015|||Wilcoxon rank sum test|||Dose-Normalized Cmax of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.00015|-0.00062|0.0032
71009450|NCT01014442|141526611|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0000126||||0.176|TWO_SIDED|95.0|-0.0000328|-0.0000091|||Wilcoxon rank sum test|||Dose-Normalized Cmax of Free MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.0000091|-0.0000328|0.1760
71103255|NCT02231580|141714582|SUPERIORITY_OR_OTHER||GLS mean ratio|1.21|||=|0.0204|TWO_SIDED|90.0|0.686|2.133|||MMRM|||Right foot IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.133|0.686|=0.0204
71009451|NCT01014442|141526612|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0043||||0.0509|TWO_SIDED|95.0|-0.00027|0.00833|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00833|-0.00027|0.0509
71009452|NCT01014442|141526612|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00567||||0.8262|TWO_SIDED|95.0|-0.03414|0.02671|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.02671|-0.03414|0.8262
71009453|NCT01014442|141526612|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.00023||||0.4345|TWO_SIDED|95.0|-0.0003|0.0007|||Wilcoxon rank sum test|||Dose-Normalized Cmax of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00070|-0.00030|0.4345
71009454|NCT01014442|141526612|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00001||||0.6472|TWO_SIDED|95.0|-0.0000586|0.0000364|||Wilcoxon rank sum test|||Dose-Normalized Cmax of Free MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000364|-0.0000586|0.6472
71009455|NCT01014442|141526613|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0333||||0.5745|TWO_SIDED|95.0|-1.95|0.5|||Wilcoxon rank sum test|||Tmax of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.5000|-1.9500|0.5745
71009456|NCT01014442|141526613|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-1.8||||0.2003|TWO_SIDED|95.0|-2.3333|0.0833|||Wilcoxon rank sum test|||Tmax of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0833|-2.3333|0.2003
71009457|NCT01014442|141526613|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.5||||0.0929|TWO_SIDED|95.0|-2.0833|0.0|||Wilcoxon rank sum test|||Tmax of AcMPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000|-2.0833|0.0929
71103256|NCT02231580|141714582|SUPERIORITY_OR_OTHER||GLS mean ratio|1.564|||=|0.0204|TWO_SIDED|90.0|1.144|2.138|||MMRM|||Left foot IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.138|1.144|=0.0204
71103257|NCT02231580|141714582|SUPERIORITY_OR_OTHER||GLS mean ratio|1.269|||=|0.3144|TWO_SIDED|90.0|0.856|1.884|||MMRM|||Right foot IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.884|0.856|=0.3144
71103258|NCT02231580|141714583|SUPERIORITY_OR_OTHER||GLS mean ratio|1.914|||=|0.0324|TWO_SIDED|90.0|1.167|3.141|||MMRM|||Left foot ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||3.141|1.167|=0.0324
71103259|NCT02231580|141714583|SUPERIORITY_OR_OTHER||GLS mean ratio|1.462|||=|0.246|TWO_SIDED|90.0|0.85|2.515|||MMRM|||Right foot ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.515|0.85|=0.246
71009458|NCT01014442|141526613|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0||||0.0823|TWO_SIDED|95.0|0.0|0.0667|||Wilcoxon rank sum test|||Tmax of Free MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0667|0.0000|0.0823
71009459|NCT01014442|141526614|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0417||||0.8106|TWO_SIDED|95.0|-0.5|1.7333|||Wilcoxon rank sum test|||Tmax of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||1.7333|-0.5000|0.8106
71103260|NCT02231580|141714583|SUPERIORITY_OR_OTHER||GLS mean ratio|1.387|||=|0.1057|TWO_SIDED|90.0|0.994|1.935|||MMRM|||Left foot ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.935|0.994|=0.1057
71103261|NCT02231580|141714583|SUPERIORITY_OR_OTHER||GLS mean ratio|1.074|||=|0.7342|TWO_SIDED|90.0|0.758|1.523|||MMRM|||Right foot ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.523|0.758|=0.7342
71009460|NCT01014442|141526614|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0||||1|TWO_SIDED|95.0|-0.1667|0.1667|||Wilcoxon rank sum test|||Tmax of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.1667|-0.1667|1.0000
71009461|NCT01014442|141526614|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0667||||0.6311|TWO_SIDED|95.0|-0.3333|1.4667|||Wilcoxon rank sum test|||Tmax of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||1.4667|-0.3333|0.6311
71009462|NCT01014442|141526614|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0||||0.433|TWO_SIDED|95.0|-0.1667|0.0167|||Wilcoxon rank sum test|||Tmax of Free MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0167|-0.1667|0.4330
71009463|NCT01014442|141526615|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0||||1|TWO_SIDED|95.0|-1.1667|0.5833|||Wilcoxon rank sum test|||Tmax of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.5833|-1.1667|1.0000
71009464|NCT01014442|141526615|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0833||||0.4947|TWO_SIDED|95.0|-2.0|0.0833|||Wilcoxon rank sum test|||Tmax of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0833|-2.0000|0.4947
71009465|NCT01014442|141526615|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.1667||||0.4425|TWO_SIDED|95.0|-1.9667|0.2|||Wilcoxon rank sum test|||Tmax of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.2000|-1.9667|0.4425
71009466|NCT01014442|141526615|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0||||0.972|TWO_SIDED|95.0|-0.05|0.0333|||Wilcoxon rank sum test|||Tmax of Free MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0333|-0.0500|0.9720
71009467|NCT01014442|141526616|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0333||||0.8834|TWO_SIDED|95.0|-1.1667|0.7|||Wilcoxon rank sum test|||Tmax of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.7000|-1.1667|0.8834
71009468|NCT01014442|141526616|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-1.8333||||0.0386|TWO_SIDED|95.0|-2.2|0.0|||Wilcoxon rank sum test|||Tmax of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000|-2.2000|0.0386
71009469|NCT01014442|141526616|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.525||||0.0558|TWO_SIDED|95.0|-2.6167|0.0|||Wilcoxon rank sum test|||Tmax of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000|-2.6167|0.0558
71009470|NCT01014442|141526616|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.15||||0.0082|TWO_SIDED|95.0|-0.2333|-0.0667|||Wilcoxon rank sum test|||Tmax of Free MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.0667|-0.2333|0.0082
71009471|NCT01014442|141526617|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.13||||0.5224|TWO_SIDED|95.0|-0.26|0.5|||Wilcoxon rank sum test|||Cmin of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.5000|-0.2600|0.5224
71009472|NCT01014442|141526617|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|11.16||||0.2088|TWO_SIDED|95.0|-5.29|30.29|||Wilcoxon rank sum test|||Cmin of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||30.2900|-5.2900|0.2088
71103262|NCT02231580|141714584|SUPERIORITY_OR_OTHER||GLS mean ratio|1.392|||=|0.1027|TWO_SIDED|90.0|0.997|1.943|||MMRM|||Left foot TF variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.943|0.997|=0.1027
71103263|NCT02231580|141714584|SUPERIORITY_OR_OTHER||GLS mean ratio|1.158|||=|0.4494|TWO_SIDED|90.0|0.84|1.595|||MMRM|||Right foot TF variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.595|0.840|=0.4494
70926219|NCT03976362|141346642|OTHER||Hazard Ratio (HR)|0.87||||0.3083|TWO_SIDED|95.0|0.66|1.14||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization Visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization Visit, response at randomization, and baseline PD-L1 expression.|||1.14|0.66|0.3083
71045843|NCT02149121|141599546|OTHER||Ratio of geometric least squares means|102.37|||||TWO_SIDED|95.0|92.46|113.33||||||Secondary PD analysis were analyzed using an ANCOVA model with results as the response, treatment group, as fixed effect and baseline values, gender, region, race, study part, interaction of treatment group with study part, prior anti-TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.|Estimate of Geometric Least Square Mean and ratio of Geometric Least Square Means (CT-P10/reference products) were obtained from back transforming the least square means from the ANCOVA.|113.33|92.46|
71045844|NCT03166124|141599547|SUPERIORITY||Ratio of Geometric LSMeans|1.02|||||TWO_SIDED|95.0|0.953|1.1|||Mixed Models Analysis|||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.10|0.953|
71045845|NCT03166124|141599547|SUPERIORITY||Ratio of Geometric LSMeans|1.03|||||TWO_SIDED|95.0|0.974|1.09|||Mixed Models Analysis|||Geometric Least Squares Means (LSMeans) were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.09|0.974|
71045846|NCT03166124|141599548|SUPERIORITY||Ratio of Geometric LSMeans|1.04|||||TWO_SIDED|95.0|0.96|1.12|||Mixed Models Analysis|||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.12|0.96|
71045847|NCT03166124|141599548|SUPERIORITY||Ratio of Geometric LSMeans|1.02|||||TWO_SIDED|95.0|0.94|1.1|||Mixed Models Analysis|||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.10|0.94|
71045848|NCT03291041|141599549|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|34.75||||0.0354|TWO_SIDED||||||ANCOVA|||||||0.0354
71045849|NCT03291041|141599550|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|-0.63||||0.0168|TWO_SIDED||||||ANCOVA|||||||0.0168
71045850|NCT03291041|141599551|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|90.56||||0.0785|TWO_SIDED||||||ANCOVA|||||||0.0785
71009473|NCT01014442|141526617|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.165||||0.1794|TWO_SIDED|95.0|-0.45|0.08|||Wilcoxon rank sum test|||Cmin of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0800|-0.4500|0.1794
71009474|NCT01014442|141526618|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.125||||0.4027|TWO_SIDED|95.0|-0.38|0.19|||Wilcoxon rank sum test|||Cmin of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.1900|-0.3800|0.4027
71009475|NCT01014442|141526618|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-16.09||||0.0875|TWO_SIDED|95.0|-29.35|6.39|||Wilcoxon rank sum test|||Cmin of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||6.3900|-29.3500|0.0875
71009476|NCT01014442|141526618|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.2||||0.0112|TWO_SIDED|95.0|-0.35|-0.05|||Wilcoxon rank sum test|||Cmin of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.0500|-0.3500|0.0112
71009477|NCT01014442|141526619|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.215||||0.0818|TWO_SIDED|95.0|-0.56|0.05|||Wilcoxon rank sum test|||Cmin of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0500|-0.5600|0.0818
71009478|NCT01014442|141526619|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-14.03||||0.0945|TWO_SIDED|95.0|-26.9|2.94|||Wilcoxon rank sum test|||Cmin of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||2.9400|-26.9000|0.0945
71009479|NCT01014442|141526619|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.19||||0.0081|TWO_SIDED|95.0|-0.41|-0.04|||Wilcoxon rank sum test|||Cmin of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.0400|-0.4100|0.0081
71009480|NCT01014442|141526620|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.36||||0.3289|TWO_SIDED|95.0|-1.14|0.28|||Wilcoxon rank sum test|||Cmin of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.2800|-1.1400|0.3289
71009481|NCT01014442|141526620|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-20.3||||0.1243|TWO_SIDED|95.0|-49.39|4.71|||Wilcoxon rank sum test|||Cmin of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||4.7100|-49.3900|0.1243
71009482|NCT01014442|141526620|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.03||||0.8704|TWO_SIDED|95.0|-0.28|0.23|||Wilcoxon rank sum test|||Cmin of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.2300|-0.2800|0.8704
71009483|NCT01014442|141526621|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|5.22||||0.4043|TWO_SIDED|95.0|-5.01|24.49|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||24.4900|-5.0100|0.4043
71009484|NCT01014442|141526622|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.44||||0.893|TWO_SIDED|95.0|-6.07|8.01|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||8.0100|-6.0700|0.8930
71009485|NCT01014442|141526623|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-4.935||||0.0819|TWO_SIDED|95.0|-14.31|1.11|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||1.1100|-14.3100|0.0819
71009486|NCT01014442|141526624|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-8.205||||0.0414|TWO_SIDED|95.0|-19.27|-0.07|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.0700|-19.2700|0.0414
71009487|NCT01014442|141526625|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|69.7186||||0.1552|TWO_SIDED|95.0|-23.4659|162.9545|||Wilcoxon rank sum test|||Vz of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||162.9545|-23.4659|0.1552
71009488|NCT01014442|141526625|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.7836||||0.6057|TWO_SIDED|95.0|-3.2675|2.5529|||Wilcoxon rank sum test|||Vz of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||2.5529|-3.2675|0.6057
71009489|NCT01014442|141526625|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|299.1021||||0.0188|TWO_SIDED|95.0|79.5869|695.1789|||Wilcoxon rank sum test|||Vz of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||695.1789|79.5869|0.0188
71045851|NCT03291041|141599552|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|78.45||||0.0225|TWO_SIDED||||||ANCOVA|||||||0.0225
70850348|NCT01247272|141188458|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.8|||||TWO_SIDED|90.0|101.66|110.12|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||110.12|101.66|
70926220|NCT03976362|141346643|OTHER||Difference in Least Square Means|1.68||||0.4686|TWO_SIDED|95.0|-2.87|6.23||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||6.23|-2.87|0.4686
70926221|NCT03976362|141346644|OTHER||Hazard Ratio (HR)|1.01||||0.9174|TWO_SIDED|95.0|0.76|1.35||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.35|0.76|0.9174
70926222|NCT03976362|141346645|OTHER||Difference in Least Square Means|3.83||||0.0245|TWO_SIDED|95.0|0.5|7.16||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||7.16|0.50|0.0245
70926223|NCT03976362|141346646|OTHER||Hazard Ratio (HR)|1.24||||0.2133|TWO_SIDED|95.0|0.88|1.75||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.75|0.88|0.2133
70926224|NCT03976362|141346647|OTHER||Hazard Ratio (HR)|0.18||||0.9381|TWO_SIDED|95.0|-4.27|4.62||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||4.62|-4.27|0.9381
70926225|NCT03976362|141346648|OTHER||Hazard Ratio (HR)|0.97||||0.8464|TWO_SIDED|95.0|0.72|1.31||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.31|0.72|0.8464
70926226|NCT03976362|141346649|OTHER||Difference in Least Square Means|-2.81||||0.087|TWO_SIDED|95.0|-6.02|0.41||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||0.41|-6.02|0.0870
70926227|NCT03976362|141346650|OTHER||Hazard Ratio (HR)|1.6||||0.002|TWO_SIDED|95.0|1.18|2.16||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||2.16|1.18|0.0020
70926228|NCT00613106|141346651|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4228||95.0|||||Cochran-Mantel-Haenszel|||||||0.4228
70926229|NCT05590403|141346834|NON_INFERIORITY|Non-inferiority is demonstrated if the anti-RSV-A GMT ratio (OA-RSV Group over Adults-HA-RSV Group) is less than (\<) 1.5 at 1 month post RSVPreF3 OA vaccine administration.|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.83|1.09|||||The comparison is done using the group ratio of adjusted GMT (OA-RSV/Adults-HA-RSV) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.||1.09|0.83|
70926230|NCT05590403|141346835|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group minus Adults-HA-RSV Group) in terms of SRR is \<10%, at 1 month post RSVPreF3 OA vaccine administration.|Difference in percentage|-2.65|||||TWO_SIDED|95.0|-8.54|3.28|||||The comparison is done using the difference of SRR (OA-RSV -Adults-HA-RSV)|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.||3.28|-8.54|
70926231|NCT05590403|141346836|NON_INFERIORITY|Non-inferiority is demonstrated if the anti-RSV-B GMT ratio (OA-RSV Group over Adults-HA-RSV Group) is \<1.5 at 1 month post RSVPreF3 OA vaccine administration.|GMT Ratio|0.89|||||TWO_SIDED|95.0|0.79|1.02|||||The comparison is done using the group ratio of adjusted GMT (OA-RSV/Adults-HA-RSV) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.||1.02|0.79|
70926232|NCT05590403|141346837|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group minus Adults-HA-RSV Group) in terms of SRR is \<10%, at 1 month post RSVPreF3 OA vaccine administration.|Difference in percentage|-3.95|||||TWO_SIDED|95.0|-10.39|2.53|||||The comparison is done using the difference of SRR (OA-RSV -Adults-HA-RSV)|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.||2.53|-10.39|
71009490|NCT01014442|141526626|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|88.959||||0.0659|TWO_SIDED|95.0|-5.7876|209.0183|||Wilcoxon rank sum test|||Vz of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||209.0183|-5.7876|0.0659
70941326|NCT00985621|141383145|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.24||0.177|TWO_SIDED|95.0|-0.78|0.14|||ANCOVA|||Change at Week 2: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.14|-0.78|0.177
71009491|NCT01014442|141526626|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.4456||||0.7842|TWO_SIDED|95.0|-3.1366|2.292|||Wilcoxon rank sum test|||Vz of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||2.2920|-3.1366|0.7842
71009492|NCT01014442|141526626|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|121.3737||||0.4072|TWO_SIDED|95.0|-233.6483|560.0069|||Wilcoxon rank sum test|||Vz of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||560.0069|-233.6483|0.4072
71009493|NCT01014442|141526627|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|207.9933||||0.004|TWO_SIDED|95.0|71.2442|355.1739|||Wilcoxon rank sum test|||Vz of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||355.1739|71.2442|0.0040
71009494|NCT01014442|141526627|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|2.6186||||0.0689|TWO_SIDED|95.0|-0.1999|6.7766|||Wilcoxon rank sum test|||Vz of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||6.7766|-0.1999|0.0689
71009495|NCT01014442|141526627|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|635.7812||||0.0306|TWO_SIDED|95.0|49.4696|2793.7642|||Wilcoxon rank sum test|||Vz of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||2793.7642|49.4696|0.0306
71009496|NCT01014442|141526628|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|4.7477||||0.9029|TWO_SIDED|95.0|-73.5212|59.8304|||Wilcoxon rank sum test|||Vz of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||59.8304|-73.5212|0.9029
71009497|NCT01014442|141526628|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0077||||0.9692|TWO_SIDED|95.0|-3.6739|3.9521|||Wilcoxon rank sum test|||Vz of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||3.9521|-3.6739|0.9692
71009498|NCT01014442|141526628|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-149.7962||||0.3744|TWO_SIDED|95.0|-644.4526|311.9735|||Wilcoxon rank sum test|||Vz of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||311.9735|-644.4526|0.3744
71009499|NCT01014442|141526629|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|7.8422||||0.1362|TWO_SIDED|95.0|-3.911|18.4444|||Wilcoxon rank sum test|||CL of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||18.4444|-3.9110|0.1362
71009500|NCT01014442|141526629|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.1609||||0.4325|TWO_SIDED|95.0|-0.5693|0.271|||Wilcoxon rank sum test|||CL of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.2710|-0.5693|0.4325
71009501|NCT01014442|141526629|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|47.2686||||0.0316|TWO_SIDED|95.0|4.197|112.7806|||Wilcoxon rank sum test|||CL of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||112.7806|4.1970|0.0316
71009502|NCT01014442|141526630|SUPERIORITY_OR_OTHER||Hodges-Lehmann estmator|19.0536||||0.0572|TWO_SIDED|95.0|-0.425|35.3852|||Wilcoxon rank sum test|||CL of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||35.3852|-0.4250|0.0572
71009503|NCT01014442|141526630|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.3541||||0.3198|TWO_SIDED|95.0|-0.2524|1.1097|||Wilcoxon rank sum test|||CL of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||1.1097|-0.2524|0.3198
71009504|NCT01014442|141526630|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|54.0322||||0.0845|TWO_SIDED|95.0|-6.7706|160.3469|||Wilcoxon rank sum test|||CL of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||160.3469|-6.7706|0.0845
71009505|NCT01014442|141526631|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|25.0037||||0.0048|TWO_SIDED|95.0|8.2373|43.5102|||Wilcoxon rank sum test|||CL of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||43.5102|8.2373|0.0048
71009506|NCT01014442|141526631|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.4297||||0.0277|TWO_SIDED|95.0|0.034|0.9925|||Wilcoxon rank sum test|||CL of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.9925|0.0340|0.0277
71009507|NCT01014442|141526631|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|318.5455||||0.0002|TWO_SIDED|95.0|154.1902|526.1716|||Wilcoxon rank sum test|||CL of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||526.1716|154.1902|0.0002
71009508|NCT01014442|141526632|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.579||||0.9417|TWO_SIDED|95.0|-14.5052|11.6346|||Wilcoxon rank sum test|||CL of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||11.6346|-14.5052|0.9417
71009509|NCT01014442|141526632|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.1817||||0.2941|TWO_SIDED|95.0|-0.1954|0.6246|||Wilcoxon rank sum test|||CL of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.6246|-0.1954|0.2941
71009510|NCT01014442|141526632|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-4.9076||||0.817|TWO_SIDED|95.0|-84.8234|109.9321|||Wilcoxon rank sum test|||CL of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||109.9321|-84.8234|0.8170
71009511|NCT01014442|141526633|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-2.4102||||0.2798|TWO_SIDED|95.0|-8.5642|3.0044|||Wilcoxon rank sum test|||AUC0-12 of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||3.0044|-8.5642|0.2798
71009512|NCT01014442|141526633|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|72.7203||||0.4063|TWO_SIDED|95.0|-107.1596|393.5295|||Wilcoxon rank sum test|||AUC0-12 of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||393.5295|-107.1596|0.4063
71009513|NCT01014442|141526633|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-3.6042||||0.0441|TWO_SIDED|95.0|-8.1854|-0.1887|||Wilcoxon rank sum test|||AUC0-12 of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.1887|-8.1854|0.0441
71009514|NCT01014442|141526634|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-5.8077||||0.051|TWO_SIDED|95.0|-11.7302|0.0033|||Wilcoxon rank sum test|||AUC0-12 of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0033|-11.7302|0.0510
71009515|NCT01014442|141526634|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-171.159||||0.2733|TWO_SIDED|95.0|-361.4437|171.9652|||Wilcoxon rank sum test|||AUC0-12 of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||171.9652|-361.4437|0.2733
71009516|NCT01014442|141526634|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-1.9621||||0.0718|TWO_SIDED|95.0|-4.8456|0.2067|||Wilcoxon rank sum test|||AUC0-12 of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.2067|-4.8456|0.0718
71009517|NCT01014442|141526635|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-8.6964||||0.0002|TWO_SIDED|95.0|-13.7713|-4.6498|||Wilcoxon rank sum test|||AUC0-12 of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-4.6498|-13.7713|0.0002
71009518|NCT01014442|141526635|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-268.9537||||0.0058|TWO_SIDED|95.0|-506.7782|-77.397|||Wilcoxon rank sum test|||AUC0-12 of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-77.3970|-506.7782|0.0058
71009519|NCT01014442|141526635|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-4.828|||<|0.0001|TWO_SIDED|95.0|-7.1455|-2.6133|||Wilcoxon rank sum test|||AUC0-12 of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-2.6133|-7.1455|<0.0001
71009520|NCT01014442|141526636|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|1.7477||||0.7144|TWO_SIDED|95.0|-12.101|14.6563|||Wilcoxon rank sum test|||AUC0-12 of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||14.6563|-12.1010|0.7144
71009521|NCT01014442|141526636|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-156.3255||||0.3413|TWO_SIDED|95.0|-526.0765|195.8348|||Wilcoxon rank sum test|||AUC0-12 of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||195.8348|-526.0765|0.3413
71045852|NCT03291041|141599553|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|0.95||||0.0198|TWO_SIDED||||||ANCOVA|||||||0.0198
71009522|NCT01014442|141526636|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.888||||0.6251|TWO_SIDED|95.0|-3.0288|4.2273|||Wilcoxon rank sum test|||AUC0-12 of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||4.2273|-3.0288|0.6251
71009523|NCT01014442|141526637|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|24.315||||0.2342|TWO_SIDED|95.0|-16.0292|79.365|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||79.3650|-16.0292|0.2342
71009524|NCT01014442|141526638|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-13.5592||||0.1964|TWO_SIDED|95.0|-37.395|5.4825|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||5.4825|-37.3950|0.1964
71045853|NCT03291041|141599554|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|-26.55||||0.0347|TWO_SIDED||||||ANCOVA|||||||0.0347
71045854|NCT03291041|141599555|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|-56.44||||0.084|TWO_SIDED||||||ANCOVA|||||||0.0840
71103264|NCT02231580|141714585|SUPERIORITY_OR_OTHER||GLS mean ratio|0.699|||=|0.035|TWO_SIDED|90.0|0.53|0.922|||MMRM|||Left foot freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||0.922|0.530|=0.0350
71103265|NCT02231580|141714585|SUPERIORITY_OR_OTHER||GLS mean ratio|0.853|||=|0.3556|TWO_SIDED|90.0|0.64|1.136|||MMRM|||Right foot freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.136|0.640|=0.3556
71103266|NCT03620981|141714586|SUPERIORITY||LS Mean Difference (Final Values)|-7.2|||<|0.0001|TWO_SIDED|95.0|-10.0|-4.3|||Mixed Models Analysis|||Statistical analysis to compare brexpiprazole 2 mg/day and placebo was performed at Week 10.||-4.3|-10.0|< 0.0001
71103267|NCT03620981|141714586|SUPERIORITY||LS Mean Difference (Final Values)|-3.7||||0.0175|TWO_SIDED|95.0|-6.8|-0.7|||Mixed Models Analysis|||Statistical analysis to compare brexpiprazole 1 mg/day and placebo was performed at Week 10.||-0.7|-6.8|0.0175
71103268|NCT03620981|141714587|SUPERIORITY||LS Mean Difference (Final Values)|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.5|||Mixed Models Analysis|||Statistical analysis to compare brexpiprazole 2 mg/day and placebo was performed at Week 10.||-0.5|-1.0|< 0.0001
71103269|NCT03620981|141714587|SUPERIORITY||LS Mean Difference (Final Values)|-0.3||||0.0083|TWO_SIDED|95.0|-0.6|-0.1|||Mixed Models Analysis|||Statistical analysis to compare brexpiprazole 1 mg/day and placebo was performed at Week 10.||-0.1|-0.6|0.0083
71103270|NCT03620981|141714588|SUPERIORITY||Mean Difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.6|||Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH), Last observation carried forward (LOCF)||Statistical analysis to compare brexpiprazole 2 mg/day and placebo was performed at Week 10.||-0.6|-1.2|< 0.0001
71103271|NCT03620981|141714588|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.0052|TWO_SIDED|95.0|-0.8|-0.1|||Cochran-Mantel-Haenszel|CMH, LOCF||Statistical analysis to compare brexpiprazole 1 mg/day and placebo was performed at Week 10.||-0.1|-0.8|0.0052
71103272|NCT04938427|141714612|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-1.17|||=|0.785|TWO_SIDED|95.0|-13.02|9.99||The p-value was calculated using Rank Analysis of Covariance (ANCOVA) model using treatment group, age stratum (≤6 years, \>6 years), and rank of Baseline seizure frequency per 28 days as predictors.|ANCOVA||The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% confidence interval (CI) are based on the Hodges-Lehmann estimation.|||9.99|-13.02|=0.785
70941327|NCT00985621|141383145|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.24||0.416|TWO_SIDED|95.0|-0.66|0.28|||ANCOVA|||Change at Week 2: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.28|-0.66|0.416
71045855|NCT03291041|141599556|SUPERIORITY||Mean Difference (Net)|-1.0||||0.0765|TWO_SIDED||||||ANCOVA|||||||0.0765
71045856|NCT00836719|141599618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|||<|0.01||95.0|3.4|16.2|||Mixed Models Analysis|Anisotropic power spatial covariance matrix with terms for time and the registered voxel. Kenward Rogers approx. for degrees of freedom.|Dependent variable: NAA. Main effect: visit. Covariates Cre, %GM, %WM, %CSF and %lesion in the voxel.|N-Acetylaspartate acid (NAA) levels were measured at baseline and exit (6 months). Voxels with less than 30% error in NAA and Creatine (Cre) were used.NAA, Cre and Proton Density were log transformed.||16.2|3.4|<0.01
71045857|NCT02678442|141599623|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
71045858|NCT02678442|141599625|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71045859|NCT02678442|141599626|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
71103273|NCT04938427|141714613|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|2.43|||=|0.778|TWO_SIDED|95.0|-10.86|15.14||The p-value was calculated using the Rank ANCOVA model using the treatment group, age stratum (≤6 years, \>6 years), and rank of Baseline seizure frequency per 28 days as predictors.|ANCOVA||The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% CI are based on the Hodges-Lehmann estimation.|||15.14|-10.86|=0.778
71103274|NCT04938427|141714614|SUPERIORITY||Odds Ratio (OR)|1.91|||||TWO_SIDED|95.0|0.94|3.87||||||||3.87|0.94|
71103275|NCT04938427|141714615|SUPERIORITY||Odds Ratio (OR)|1.93|||||TWO_SIDED|95.0|0.92|4.05||||||||4.05|0.92|
71103276|NCT04938427|141714617|SUPERIORITY||Odds Ratio (OR)|1.35|||||TWO_SIDED|95.0|0.86|2.13||||||||2.13|0.86|
71103277|NCT04938427|141714618|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.89|2.21||||||||2.21|0.89|
71103278|NCT04938427|141714619|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.85|2.3||||||Alertness Domain||2.30|0.85|
71103279|NCT04938427|141714619|SUPERIORITY||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|0.91|2.48||||||Communication Domain||2.48|0.91|
71103280|NCT04938427|141714619|SUPERIORITY||Odds Ratio (OR)|1.91|||||TWO_SIDED|95.0|1.06|3.43||||||Disruptive Behaviors Domain||3.43|1.06|
71103281|NCT04938427|141714620|SUPERIORITY||Least Square Mean Difference|0.52|||||TWO_SIDED|95.0|-2.2|3.24||||||||3.24|-2.20|
71103282|NCT04938427|141714621|SUPERIORITY||Odds Ratio (OR)|1.67|||||TWO_SIDED|95.0|1.06|2.65||||||||2.65|1.06|
71103283|NCT04938427|141714622|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-6.37|||||TWO_SIDED|95.0|-16.83|4.16|||||The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% CI are based on the Hodges-Lehmann estimation.|||4.16|-16.83|
71045860|NCT02678442|141599627|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||.001
71045861|NCT01045993|141599630|SUPERIORITY_OR_OTHER|||||||0.046|TWO_SIDED|||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|Proportional hazards regression model|P-value calculated using proportional hazards model with treatment term only in the model.||||||0.046
71045862|NCT01045993|141599631|NON_INFERIORITY_OR_EQUIVALENCE|The statistical alternative hypothesis tested is that the survival curves of time to first perceptible relief confirmed by meaningful relief are not identical between two treatment groups, or equivalently, the hazard ratio between two treatment groups is not equal to 1.||||||0.046|TWO_SIDED|||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|Proportional hazards regression model|P-value calculated using proportional hazards model with treatment term only in the model.||||||0.046
71045863|NCT01045993|141599632|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value calculated using analysis of variance (ANOVA) model with treatment term only in the model.||||||<0.001
71045864|NCT01045993|141599633|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value calculated using ANOVA model with treatment term only in the model.||||||0.002
71045865|NCT01045993|141599635|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||60 minutes timepoint||||0.012
71045866|NCT01045993|141599635|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||120 minutes timepoint||||0.016
71045867|NCT01045993|141599635|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||180 minutes timepoint||||<0.001
71045868|NCT01045993|141599635|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||240 minutes timepoint||||0.002
71045869|NCT01045993|141599635|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||300 minutes timepoint||||<0.001
71045870|NCT01045993|141599635|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||360 minutes timepoint||||<0.001
71045871|NCT01045993|141599635|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||420 minutes timepoint||||0.003
71045872|NCT01045993|141599635|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||480 minutes timepoint||||0.001
71045873|NCT01045993|141599636|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||60 minutes timepoint||||0.012
71045874|NCT01045993|141599636|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||120 minutes timepoint||||0.002
71045875|NCT01045993|141599636|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||180 minutes timepoint||||0.033
71045876|NCT01045993|141599636|SUPERIORITY_OR_OTHER|||||||0.096||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||240 minutes timepoint||||0.096
71045877|NCT01045993|141599636|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||300 minutes timepoint||||0.002
70926233|NCT05590403|141346838|NON_INFERIORITY|Non-inferiority is demonstrated if the anti-RSV-A GMT ratio (OA-RSV Group over Adults-AIR-RSV Group) is \<1.5 at 1 month post RSVPreF3 OA vaccine administration.|GMT Ratio|0.84|||||TWO_SIDED|95.0|0.73|0.96|||||The comparison is done using the group ratio of adjusted GMT (OA-RSV/Adults-AIR-RSV) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.||0.96|0.73|
70926234|NCT05590403|141346839|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group over Adults-AIR-RSV Group) in terms of SRR is \<10%, at 1 month post RSVPreF3 OA vaccine administration.|Difference in percentage|-6.67|||||TWO_SIDED|95.0|-12.26|-1.12|||||The comparison is done using the difference of SRR (OA-RSV -Adults-AIR-RSV)|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.||-1.12|-12.26|
70926235|NCT05590403|141346840|NON_INFERIORITY|Non-inferiority is demonstrated if the anti-RSV-B GMT ratio (OA-RSV Group over Adults-AIR-RSV Group) is \<1.5 at 1 month post RSVPreF3 OA vaccine administration.|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.71|0.91|||||The comparison is done using the group ratio of adjusted GMT (OA-RSV/Adults-AIR-RSV) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.||0.91|0.71|
70926236|NCT05590403|141346841|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group over Adults-AIR-RSV Group) in terms of SRR is \<10%, at 1 month post RSVPreF3 OA vaccine administration.|Difference in percentage|-7.31|||||TWO_SIDED|95.0|-13.52|-1.09|||||The comparison is done using the difference of SRR (OA-RSV -Adults-AIR-RSV)|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.||-1.09|-13.52|
70926237|NCT04856163|141346878|SUPERIORITY|||||||0.08|||||||Regression, Logistic|||||||0.08
70926238|NCT04856163|141346879|SUPERIORITY|||||||0.21|||||||discrete-time survival model|||||||0.21
70926239|NCT04856163|141346880|SUPERIORITY|||||||0.28|||||||Regression, Logistic|||||||0.28
70926240|NCT04856163|141346881|SUPERIORITY|||||||0.05|||||||Regression, Linear|||||||0.05
70926241|NCT03158714|141346905|SUPERIORITY||Mean Difference (Net)|0.033||||0.005|TWO_SIDED|||||The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Utilized multi-level modeling to account for nested data (individuals within couples), and accounted for time within individual.||||||.005
70926242|NCT03158714|141346905|SUPERIORITY||Mean Difference (Net)|0.02||||0.101|TWO_SIDED|||||The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Utilized multi-level modeling to account for nested data (individuals within couples), and accounted for time within individual.||||||.101
70926243|NCT03158714|141346906|SUPERIORITY||Mean Difference (Net)|3.96|||<|0.001|TWO_SIDED|||||The a priori threshold for statistical significance was .05.|Regression, Linear|Utilized multi-level modeling to account for nested data (individuals within couples), and controlled for baseline levels of outcome in regression.||||||< .001
70926244|NCT03158714|141346906|SUPERIORITY||Mean Difference (Net)|4.09|||<|0.001|TWO_SIDED|||||The a priori threshold for statistical significance was .05.|Regression, Linear|Utilized multi-level modeling to account for nested data (individuals within couples), and controlled for baseline levels of outcome in regression.||||||< .001
70926245|NCT03158714|141346907|SUPERIORITY||Mean Difference (Net)|0.343||||0.003|TWO_SIDED|||||The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Utilized multi-level modeling to account for nested data (individuals within couples), and accounted for time within individual.||||||.003
70926246|NCT03158714|141346907|SUPERIORITY||Mean Difference (Net)|0.172||||0.152|TWO_SIDED|||||The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Utilized multi-level modeling to account for nested data (individuals within couples), and accounted for time within individual.||||||.152
70941328|NCT00985621|141383145|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.5|-0.46|||ANCOVA|||Change at Week 4: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.46|-1.50|<0.001
71045878|NCT01045993|141599636|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||360 minutes timepoint||||0.005
71009525|NCT01014442|141526639|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-22.7878||||0.0672|TWO_SIDED|95.0|-44.8217|3.7573|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||3.7573|-44.8217|0.0672
71009526|NCT01014442|141526640|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-21.4737||||0.2453|TWO_SIDED|95.0|-64.1567|8.5708|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||8.5708|-64.1567|0.2453
71009527|NCT01014442|141526641|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00237||||0.1362|TWO_SIDED|95.0|-0.00734|0.00106|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00106|-0.00734|0.1362
71009528|NCT01014442|141526641|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.04797||||0.4325|TWO_SIDED|95.0|-0.08467|0.26322|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.26322|-0.08467|0.4325
71009529|NCT01014442|141526641|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00311||||0.0316|TWO_SIDED|95.0|-0.00645|-0.00029|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.00029|-0.00645|0.0316
71009530|NCT01014442|141526641|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0000158||||0.3269|TWO_SIDED|95.0|-0.0000134|0.0000552|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of Free MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000552|-0.0000134|0.3269
71045879|NCT01045993|141599636|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||420 minutes timepoint||||0.008
71045880|NCT01045993|141599636|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||480 minutes timepoint||||0.004
71045881|NCT01045993|141599637|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees||||0.268
71045882|NCT01045993|141599637|SUPERIORITY_OR_OTHER|||||||0.419||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees||||0.419
71045883|NCT01045993|141599637|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Plus 5 degrees (beyond maximum)||||0.086
71045884|NCT01045993|141599638|SUPERIORITY_OR_OTHER|||||||0.067||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees||||0.067
71045885|NCT01045993|141599638|SUPERIORITY_OR_OTHER|||||||0.757||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees||||0.757
71045886|NCT01045993|141599638|SUPERIORITY_OR_OTHER|||||||0.219||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Plus 5 degrees (beyond maximum)||||0.219
71045887|NCT01045993|141599639|SUPERIORITY_OR_OTHER|||||||0.043||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees||||0.043
71045888|NCT01045993|141599639|SUPERIORITY_OR_OTHER|||||||0.388||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees||||0.388
71045889|NCT01045993|141599639|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Plus 5 degrees (beyond maximum)||||0.039
71045890|NCT01045993|141599640|SUPERIORITY_OR_OTHER|||||||0.797||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||||||0.797
70926247|NCT03897465|141346971|NON_INFERIORITY|Pre-specified non-inferiority margin was 10%|Risk Difference (RD)|1.4|||||TWO_SIDED|95.0|-10.0||Upper Limit= +Infinity|||||Descriptive analysis of the primary endpoint was provided on per protocol population. The overall difference LomatuellPro (LP) - UrgoTul (UT) of the % of patients meeting main efficacy criterion was calculated with 95% bilateral confidence interval (CI). If lower limit of the 95% CI did not exceed the -10% value of pre-specified non-inferiority margin, non-inferiority had to be accepted. As a sensitivity analysis, the same analysis was performed on mITT (modified Intention-to-treat) population.|||-10|
70926248|NCT05119023|141346976|OTHER|||||||0.39||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Language Severity and Characterization of learning: SRT Observational Learning Scores||||0.39
71103284|NCT04938427|141714623|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-6.65|||||TWO_SIDED|95.0|-16.67|3.12|||||The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% CI are based on the Hodges-Lehmann estimation.|||3.12|-16.67|
71103285|NCT04938427|141714624|SUPERIORITY||LS Mean Difference|2.47|||||TWO_SIDED|95.0|-1.74|6.67|||||A linear model with treatment group and age stratum as factors and baseline percentage as a covariate was used for analysis.|||6.67|-1.74|
71045891|NCT01045993|141599641|SUPERIORITY_OR_OTHER|||||||0.371||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||||||0.371
71045892|NCT01045993|141599642|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||||||0.122
71045893|NCT01045993|141599643|SUPERIORITY_OR_OTHER|||||||0.355||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees||||0.355
71045894|NCT01045993|141599643|SUPERIORITY_OR_OTHER|||||||0.371||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees||||0.371
71045895|NCT01045993|141599643|SUPERIORITY_OR_OTHER|||||||0.216||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-values from ANOVA model with treatment treatment term only in the model.||At Plus 5 degrees (beyond maximum)||||0.216
71045896|NCT01045993|141599644|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees||||0.054
71103286|NCT04938427|141714625|SUPERIORITY||LS Mean Difference|5.4|||||TWO_SIDED|95.0|1.9|8.9||||||||8.9|1.9|
71103287|NCT04938427|141714626|SUPERIORITY||LS Mean Difference|-0.9|||||TWO_SIDED|95.0|-3.7|2.0||||||||2.0|-3.7|
71103288|NCT03977155|141714634|SUPERIORITY|Individual BOS-589 dose levels versus placebo were only to be tested if pooled BOS-589 doses versus placebo was significant at p\<0.05.|Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|0.35||0.3776|TWO_SIDED|95.0|-1.0|0.38|||t test|P-values were calculated from the independent two-sample t test with equal variance.||Statistical Analysis 1||0.38|-1.00|0.3776
71103289|NCT03977155|141714634|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-0.73|0.82||||||Statistical Analysis 2||0.82|-0.73|
71103290|NCT03977155|141714634|SUPERIORITY||Mean Difference (Net)|-0.61|STANDARD_ERROR_OF_MEAN|0.403|||TWO_SIDED|95.0|-1.41|0.19||||||Statistical Analysis 3||0.19|-1.41|
71103291|NCT03977155|141714634|SUPERIORITY||Mean Difference (Net)|0.65|STANDARD_ERROR_OF_MEAN|0.397|||TWO_SIDED|95.0|-0.13|1.44||||||Statistical Analysis 4||1.44|-0.13|
71009531|NCT01014442|141526642|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00383||||0.0572|TWO_SIDED|95.0|-0.00761|0.0001|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00010|-0.00761|0.0572
71009532|NCT01014442|141526642|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.09626||||0.3198|TWO_SIDED|95.0|-0.25269|0.11464|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.11464|-0.25269|0.3198
71009533|NCT01014442|141526642|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00131||||0.0845|TWO_SIDED|95.0|-0.00352|0.00013|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00013|-0.00352|0.0845
71009534|NCT01014442|141526642|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00001||||0.1769|TWO_SIDED|95.0|-0.000025|0.0000043|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of Free MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000043|-0.0000250|0.1769
71009535|NCT01014442|141526643|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0049||||0.0048|TWO_SIDED|95.0|-0.00876|-0.00148|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.00148|-0.00876|0.0048
71009536|NCT01014442|141526643|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.14764||||0.0277|TWO_SIDED|95.0|-0.31026|-0.01067|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.01067|-0.31026|0.0277
71009537|NCT01014442|141526643|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0035||||0.0002|TWO_SIDED|95.0|-0.00476|0.00168|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00168|-0.00476|0.0002
71045897|NCT01045993|141599644|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees||||0.600
71009538|NCT01014442|141526643|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0000138||||0.1661|TWO_SIDED|95.0|-0.0000295|0.0000047|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of Free MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000047|-0.0000295|0.1661
70926249|NCT05119023|141346976|OTHER||||||<|0.01||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Language severity and Characterization of learning: AGL Observational Learning Scores||||<0.01
71009539|NCT01014442|141526644|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.00054||||0.9417|TWO_SIDED|95.0|-0.01037|0.01042|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.01042|-0.01037|0.9417
71009540|NCT01014442|141526644|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.1461||||0.2941|TWO_SIDED|95.0|-0.39951|0.12988|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.12988|-0.39951|0.2941
71009541|NCT01014442|141526644|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.00033||||0.817|TWO_SIDED|95.0|-0.00361|0.00421|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00421|-0.00361|0.8170
71009542|NCT01014442|141526644|SUPERIORITY_OR_OTHER||Hodge-Lehmann estimator|-0.0000239||||0.1927|TWO_SIDED|95.0|-0.0000594|0.0000154|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of Free MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000154|-0.0000594|0.1927
71009543|NCT01014442|141526645|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.1616||||0.0821|TWO_SIDED|95.0|-0.0121|0.4188|||Wilcoxon rank sum test|||Free Fraction of Free MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.4188|-0.0121|0.0821
71009544|NCT01014442|141526646|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0427||||0.3628|TWO_SIDED|95.0|-0.0455|0.1221|||Wilcoxon rank sum test|||Free Fraction of Free MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.1221|-0.0455|0.3628
71009545|NCT01014442|141526647|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.001||||0.9873|TWO_SIDED|95.0|-0.1152|0.1173|||Wilcoxon rank sum test|||Free Fraction of Free MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.1173|-0.1152|0.9873
70926250|NCT05119023|141346976|OTHER|||||||0.95||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Language severity and Characterization of learning: AGL Rule-based Learning Scores||||0.95
70926251|NCT05119023|141346977|OTHER|Sample underpowered for regression so correlation examined||||||0.36||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Attention and Characterization of learning: SRT Observational Learning Scores||||0.36
70926252|NCT05119023|141346977|OTHER|||||||0.09|||||||Pearson's correlation|The threshold for statistical significance was p = 0.05||Examination of Attention and Characterization of learning: AGL Observational Learning Scores||||0.09
70926253|NCT05119023|141346977|OTHER|||||||0.32||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Attention and Characterization of learning: AGL Rule Based Learning||||0.32
70926254|NCT05119023|141346978|OTHER|Sample underpowered for regression so correlation examined||||||0.64||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Working Memory and Characterization of learning: SRT Observational Learning Scores||||0.64
70926255|NCT05119023|141346978|OTHER|||||||0.01||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Working Memory and Characterization of learning: AGL Observational Learning Scores||||0.01
70926256|NCT05119023|141346978|OTHER|||||||0.79|||||||Pearson's correlation|||Examination of Working Memory and Characterization of learning: AGL Rule-based Learning Scores||||0.79
70926257|NCT05119023|141346979|OTHER|Sample underpowered for regression so correlation examined||||||0.9||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Executive Function and Characterization of learning: SRT Observational Learning Scores||||0.90
70926258|NCT05119023|141346979|OTHER|||||||0.09||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Executive Function and Characterization of learning: AGL Observational Learning Scores||||0.09
70926259|NCT05119023|141346979|OTHER|||||||0.24|||||||Pearson's correlation|||Examination of Executive Function and Characterization of learning: AGL Rule-based Learning Scores||||0.24
70926260|NCT00875277|141347018|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70926261|NCT00875277|141347018|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70926262|NCT00875277|141347018|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70926263|NCT00875277|141347018|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70926264|NCT00875277|141347018|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70926265|NCT00875277|141347018|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70926266|NCT00875277|141347018|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||0.035
70926267|NCT00875277|141347018|SUPERIORITY|||||||0.082|||||||t-test, 2 sided|||||||0.082
70926268|NCT00875277|141347018|SUPERIORITY|||||||0.009|||||||t-test, 2 sided|||||||0.009
70926269|NCT00875277|141347018|SUPERIORITY|||||||0.012|||||||t-test, 2 sided|||||||0.012
70926270|NCT00875277|141347018|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70926271|NCT00875277|141347018|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70926272|NCT00875277|141347018|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70926273|NCT00875277|141347018|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70926274|NCT00875277|141347018|SUPERIORITY|||||||0.089|||||||t-test, 2 sided|||||||0.089
70926275|NCT04292223|141347038|OTHER|Comparison of the 16-week value with the baseline value|Mean Difference (Final Values)|14.0|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|8.8|19.3|||Mixed Models Analysis|||||19.3|8.8|<0.0001
70926276|NCT04963270|141347049|SUPERIORITY||Difference in Adjusted Mean|-1.02|STANDARD_DEVIATION|0.44||0.0196|TWO_SIDED|95.0|-1.88|-0.16|||ANCOVA and Conditional Mean Imputation|||||-0.16|-1.88|0.0196
70926277|NCT04963270|141347050|SUPERIORITY||Difference in Adjusted Mean|-1.02|STANDARD_ERROR_OF_MEAN|0.41||0.0123|TWO_SIDED|95.0|-1.82|-0.22|||ANCOVA and Conditional Mean Imputation|||||-0.22|-1.82|0.0123
70926278|NCT04963270|141347051|SUPERIORITY||Difference in Response Rate|-12.7||||0.088|TWO_SIDED|95.0|-27.3|1.9|||Cochran-Mantel-Haenszel|||Stratified Analysis||1.9|-27.3|0.088
70926279|NCT04963270|141347052|SUPERIORITY||Difference in Response Rate|-10.5||||0.137|TWO_SIDED|95.0|-24.2|3.3|||Cochran-Mantel-Haenszel|||Stratified Analysis||3.3|-24.2|0.137
70926280|NCT04963270|141347053|SUPERIORITY||Difference in Adjusted Mean|-1.63|STANDARD_ERROR_OF_MEAN|0.6||0.0062|TWO_SIDED|95.0|-2.8|-0.46|||ANCOVA and Conditional Mean Imputation|||||-0.46|-2.80|0.0062
70926281|NCT04963270|141347054|SUPERIORITY||Difference in adjusted Mean|-1.68|STANDARD_ERROR_OF_MEAN|0.57||0.0034|TWO_SIDED|95.0|-2.8|-0.56|||ANCOVA and Conditional Mean Imputation|||||-0.56|-2.80|0.0034
70926282|NCT04963270|141347055|SUPERIORITY||Difference in Adjusted Mean|-1.51|STANDARD_ERROR_OF_MEAN|0.94||0.1094|TWO_SIDED|95.0|-3.36|0.34|||ANCOVA and Conditional Mean Imputation|||||0.34|-3.36|0.1094
70926283|NCT04963270|141347056|SUPERIORITY||Difference in Adjusted Mean|-1.39|STANDARD_ERROR_OF_MEAN|0.85||0.0999|TWO_SIDED|95.0|-3.05|0.27|||ANCOVA and Conditional Mean Imputation|||||0.27|-3.05|0.0999
70926284|NCT04963270|141347057|SUPERIORITY||Difference in Adjusted Mean|-2.2|STANDARD_ERROR_OF_MEAN|1.1||0.0456|TWO_SIDED|95.0|-4.36|-0.04|||ANCOVA and Conditional Mean Imputation|||||-0.04|-4.36|0.0456
70926285|NCT04963270|141347058|SUPERIORITY||Difference in Adjusted Mean|-2.11|STANDARD_ERROR_OF_MEAN|1.02||0.0382|TWO_SIDED|95.0|-4.1|-0.11|||ANCOVA and Conditional Mean Imputation|||||-0.11|-4.10|0.0382
70926286|NCT04963270|141347059|SUPERIORITY|Stratified Analysis|Difference in Response Rate|-18.7||||0.013|TWO_SIDED|95.0|-33.5|-3.9|||Cochran-Mantel-Haenszel|||||-3.9|-33.5|0.013
70926287|NCT04963270|141347060|SUPERIORITY|Stratified Analysis|Difference in Response Rate|-22.0||||0.002|TWO_SIDED|95.0|-36.2|-7.9|||Cochran-Mantel-Haenszel|||||-7.9|-36.2|0.002
71045898|NCT01045993|141599644|SUPERIORITY_OR_OTHER|||||||0.294||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Plus 5 degrees (beyond maximum)||||0.294
71045899|NCT01045993|141599645|SUPERIORITY_OR_OTHER|||||||0.088||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees||||0.088
71045900|NCT01045993|141599645|SUPERIORITY_OR_OTHER|||||||0.625||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees||||0.625
71045901|NCT01045993|141599645|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Plus 5 degrees (beyond maximum)||||0.034
71045902|NCT01045993|141599646|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|Cochran-Mantel-Haenszel|P-value from the Cochran-Mantel-Haenszel test with modified ridit scores.||||||<0.001
71045903|NCT01659736|141599648|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||p-value is for the condition (active TMS versus Sham) by time (pre, post, 3-month follow-up) interaction|ANOVA|||||||0.006
71045904|NCT00391079|141599653|SUPERIORITY_OR_OTHER||Estimated treatment effect|-0.17||||0.468|TWO_SIDED|95.0|-0.62|0.29|||ANCOVA|||The change in pain NRS score from baseline to the end of study was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and centre group and treatment as factors.||0.29|-0.62|0.468
71045905|NCT00391079|141599654|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.309||||0.2338|TWO_SIDED|95.0|0.84|2.038|||Regression, Logistic|||The proportions of responders were compared between the treatment groups using logistic regression with region and treatment groups as factors. The null hypothesis was that there was no difference between each Sativex and placebo.||2.038|0.840|0.2338
71045906|NCT00391079|141599655|SUPERIORITY_OR_OTHER||Estimated treatment effect|-1.83||||0.3103|TWO_SIDED|95.0|-5.39|1.72|||ANOVA||A negative difference in estimated treatment effect indicates an improvement in pain in favour of Sativex.|The change in NPS score from baseline to the end of study was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and centre group and treatment as factors.||1.72|-5.39|0.3103
71103292|NCT03977155|141714636|SUPERIORITY|Individual BOS-589 dose levels versus placebo were only to be tested if pooled BOS-589 doses versus placebo was significant at p\<0.05.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.211||0.884|TWO_SIDED|95.0|-0.45|0.39|||t test|P-values were calculated from the independent two-sample t test with equal variance.||Statistical Analysis 1||0.39|-0.45|0.8840
71045907|NCT00391079|141599656|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.24||||0.1567|TWO_SIDED|95.0|-0.57|0.09|||ANCOVA||A negative difference in estimated treatment difference indicates a reduction in breakthrough analgesic medication in favour of Sativex.|The change in average number of tablets taken daily from baseline to the end of study was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and centre group and treatment as factors.||0.09|-0.57|0.1567
71045908|NCT00391079|141599657|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.12||||0.5643|TWO_SIDED|95.0|-0.53|0.29|||ANCOVA||A negative difference in estimated means indicates an improvement in pain in favour of Sativex.|||0.29|-0.53|0.5643
71045909|NCT00391079|141599658|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.47||||0.0552|TWO_SIDED|95.0|0.991|2.179|||Regression, Logistic||An odds ratio of greater than 1 indicates and improvement in favour of Sativex.|||2.179|0.991|0.0552
71045910|NCT00391079|141599659|SUPERIORITY_OR_OTHER||estimated treatment difference|0.05||||0.833|TWO_SIDED|95.0|-0.39|0.48|||ANCOVA||A negative difference in estimated treatment difference indicates an improvement in sleep quality in favour of Sativex.|||0.48|-0.39|0.8330
71045911|NCT00262041|141599668|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad+ vaccine against the serogroup A was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup A compared with that of MenACWY PS vaccine.||||<0.001
71045912|NCT00262041|141599668|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad- vaccine against the serogroup A was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup A compared with that of MenACWY PS vaccine.||||<0.001
71045913|NCT00262041|141599668|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad+ vaccine against the serogroup C was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup C compared with that of MenACWY PS vaccine.||||<0.001
70926288|NCT04963270|141347061|SUPERIORITY||Difference in Adjusted Mean|-2.99|STANDARD_ERROR_OF_MEAN|0.81||0.0002|TWO_SIDED|95.0|-4.57|-1.41|||ANCOVA and Conditional Mean Imputation|||||-1.41|-4.57|0.0002
71045914|NCT00262041|141599668|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad- vaccine against the serogroup C was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.||||||0.003||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup C compared with that of MenACWY PS vaccine.||||0.003
71103293|NCT03977155|141714636|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.249|||TWO_SIDED|95.0|-0.6|0.39||||||Statistical Analysis 2||0.39|-0.60|
71103294|NCT03977155|141714636|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.231|||TWO_SIDED|95.0|-0.43|0.49||||||Statistical Analysis 3||0.49|-0.43|
70926289|NCT04963270|141347062|SUPERIORITY||Difference in Adjusted Mean|-3.0|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED|95.0|-4.47|-1.53|||ANCOVA and Conditional Mean Imputation|||||-1.53|-4.47|<0.0001
70926290|NCT04963270|141347063|SUPERIORITY||Difference in Response Rate|-21.0||||0.004|TWO_SIDED|95.0|-35.4|-6.6|||Cochran-Mantel-Haenszel|||||-6.6|-35.4|0.004
70926291|NCT04963270|141347064|SUPERIORITY|Stratified Analysis|Difference in Response Rate|-19.4||||0.005|TWO_SIDED|95.0|-32.8|-5.9|||Cochran-Mantel-Haenszel|||||-5.9|-32.8|0.005
70926292|NCT04963270|141347065|SUPERIORITY||Difference in Response Rate|-1.7||||0.847|TWO_SIDED|95.0|-19.4|15.9|||Cochran-Mantel-Haenszel|||||15.9|-19.4|0.847
70926293|NCT04963270|141347066|SUPERIORITY|Stratified Analysis|Difference in Response Rate|-4.3||||0.441|TWO_SIDED|95.0|-15.4|6.7|||Cochran-Mantel-Haenszel|||||6.7|-15.4|0.441
70926294|NCT04963270|141347067|SUPERIORITY||Difference in Response Rate|8.5||||0.115|TWO_SIDED|95.0|-2.1|19.0|||Cochran-Mantel-Haenszel|||||19|-2.1|0.115
70926295|NCT04963270|141347068|SUPERIORITY|Stratified Analysis|Difference in Response Rate|8.8||||0.077|TWO_SIDED|95.0|-1.0|18.6|||Cochran-Mantel-Haenszel|||||18.6|-1|0.077
70926296|NCT04963270|141347069|SUPERIORITY||Risk Difference|-6.77||||0.1314|TWO_SIDED|95.0|-17.25|3.7|||Cochran-Mantel-Haenszel|||||3.70|-17.25|0.1314
70926297|NCT04963270|141347070|SUPERIORITY|Stratified Analysis|Risk Difference|-5.07||||0.2264|TWO_SIDED|95.0|-14.74|4.61|||Cochran-Mantel-Haenszel|||||4.61|-14.74|0.2264
70926298|NCT04963270|141347071|SUPERIORITY||Difference in Adjusted Mean|3.44|STANDARD_ERROR_OF_MEAN|1.45||0.0179|TWO_SIDED|95.0|0.59|6.29|||ANCOVA and Conditional Mean Imputation|||||6.29|0.59|0.0179
70926299|NCT04963270|141347072|SUPERIORITY|Stratified Analysis|Difference in Adjusted Mean|3.73|STANDARD_ERROR_OF_MEAN|1.37||0.0066|TWO_SIDED|95.0|1.04|6.42|||ANCOVA and Conditional Mean Imputation|||||6.42|1.04|0.0066
70926300|NCT04026555|141347078|SUPERIORITY||Risk Ratio (RR)|1.43|||<|0.001|TWO_SIDED|95.0|1.16|1.78|||Regression, Poisson|||IPTW Poisson regression was used to model the number of escalations per visit with an offset of the log transformed length of stay normalized per 1000 bed days. Treatment effect is expressed in terms of adjusted incidence rate ratio (IRR) per 1000 patient bed days.||1.78|1.16|< 0.001
70926301|NCT04026555|141347079|SUPERIORITY||Risk Ratio (RR)|1.74|||<|0.001|TWO_SIDED|95.0|1.39|2.18||Correction for multiple comparisons was performed on all key outcomes within the primary and secondary hypotheses, respectively, using the false discovery rate method (FDR).|Regression, Logistic|||IPTW log-binomial regres- sion models were used to model the secondary and ad hoc outcomes. Treatment effect is expressed as adjusted relative risk (RR).||2.18|1.39|<0.001
70926302|NCT04026555|141347082|SUPERIORITY||Risk Ratio (RR)|0.76||||0.045|TWO_SIDED|95.0|0.58|0.99||Correction for multiple comparisons was performed on all key outcomes within the primary and secondary hypotheses, respectively, using the false discovery rate method (FDR).|Regression, Logistic|||IPTW log-binomial regression models were used to model the secondary and ad hoc outcomes. Treatment effect is expressed as adjusted relative risk (RR).||0.99|0.58|0.045
70926303|NCT04026555|141347087|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.14|TWO_SIDED|95.0|0.98|1.18|||Regression, Cox|||||1.18|0.98|0.14
70926304|NCT03097549|141347201|SUPERIORITY||Estimated difference|-3.1||||0.001|TWO_SIDED|95.0|-4.8|-1.3|||Mixed Models Analysis|||Comparison of mean scores using a linear mixed model, incorporating baseline data and accounting for all available data. Sample size calculation: We anticipated ICIQ-UI SF improvements of 2.5 points in the treatment group and 0.9 points in the information group. Detecting this difference with 80% power, a two-sided test, and a significance level of P\<.05 would require a sample size of 49 in each group. With an expected drop-out rate of 20%, we needed approximately 60 participants in each group.||-1.3|-4.8|0.001
70926305|NCT03097549|141347202|SUPERIORITY||Estimated difference|-6.3||||0.004|TWO_SIDED|95.0|-10.5|-2.1|||Mixed Models Analysis|||Null hypothesis: There is no difference in score between the treatment group and the information group at follow-up.||-2.1|-10.5|0.004
70926306|NCT03097549|141347203|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||"Null hypothesis: There is no difference in the number of urinary leakage episodes between the treatment app users and the information app users at follow-up.~ITT analysis. Missing data: 5 participants in the treatment group and 2 participants in the information group had a missing value at follow-up, and for those, the difference was set to 0 (ie, no change)."||||<0.001
70926307|NCT03097549|141347204|SUPERIORITY||Estimated difference|-1.8|||<|0.001|TWO_SIDED|95.0|-2.8|-0.9|||Mixed Models Analysis|||Null hypothesis: There is no difference in score between the treatment group and the information group at follow-up.||-0.9|-2.8|<0.001
70926308|NCT03097549|141347205|SUPERIORITY||Estimated difference|-1.6||||0.016|TWO_SIDED|95.0|-2.8|-0.3|||Mixed Models Analysis|||Null hypothesis: There is no difference in score between the treatment group and the information group at follow-up.||-0.3|-2.8|0.016
70926309|NCT03097549|141347206|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: no difference in usage between treatment group and information group at follow-up.||||0.01
70926310|NCT03097549|141347207|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference in improvement between the treatment group and the information group att follow-up.||||<0.001
70926311|NCT02547233|141347209|SUPERIORITY||Ratio of clearance rates|30.55|||<|0.001|TWO_SIDED|95.0|4.28|218.0|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.|||218.0|4.28|<0.001
70926312|NCT02547233|141347210|SUPERIORITY||Ratio of clearance rates|12.26|||<|0.001|TWO_SIDED|95.0|4.73|31.78|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||31.78|4.73|<0.001
70926313|NCT02547233|141347211|SUPERIORITY||Ratio of clearance rates|10.31|||<|0.001|TWO_SIDED|95.0|4.43|23.97|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||23.97|4.43|<0.001
71045915|NCT00262041|141599668|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad+ vaccine against the serogroup W was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup W compared with that of MenACWY PS vaccine.||||<0.001
71045916|NCT00262041|141599668|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad- vaccine against the serogroup W was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.||||||0.071||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup W compared with that of MenACWY PS vaccine.||||0.071
71045917|NCT00262041|141599668|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad+ vaccine against the serogroup Y was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup Y compared with that of MenACWY PS vaccine.||||<0.001
71045918|NCT00262041|141599668|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad- vaccine against the serogroup Y was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup Y compared with that of MenACWY PS vaccine.||||<0.001
71045919|NCT02384941|141599681|SUPERIORITY||Least squares mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.047|<|0.001|TWO_SIDED|||||Threshold for significance \< 0.05.|MMRM|||||||<0.001
71045920|NCT02384941|141599681|SUPERIORITY||Least squares mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.047|<|0.001|TWO_SIDED|95.0||||Threshold for significance \< 0.05.|MMRM|||||||< 0.001
71045921|NCT02384941|141599682|SUPERIORITY||Percentage difference|11.8||||0.002|TWO_SIDED|95.0|4.28|19.36||Threshold for significance \< 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint of each treatment comparison was statistically significant at 0.05 level.||19.36|4.28|0.002
71045922|NCT02384941|141599682|SUPERIORITY||Percentage difference|21.9|||<|0.001|TWO_SIDED|95.0|14.1|29.64||Threshold for significance \< 0.05.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||29.64|14.10|< 0.001
71045923|NCT02384941|141599683|SUPERIORITY||Least squares mean difference|-2.35|STANDARD_ERROR_OF_MEAN|0.256|<|0.001|TWO_SIDED|95.0|-2.85|-1.85||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-1.85|-2.85|< 0.001
71045924|NCT02384941|141599683|SUPERIORITY||Least squares mean difference|-3.45|STANDARD_ERROR_OF_MEAN|0.256|<|0.001|TWO_SIDED|95.0|-3.95|-2.94||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-2.94|-3.95|< 0.001
71045925|NCT02384941|141599684|SUPERIORITY||Least squares mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.917||0.1|TWO_SIDED|95.0|-3.3|0.3||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||0.30|-3.30|0.10
71103295|NCT03977155|141714636|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.247|||TWO_SIDED|95.0|-0.63|0.36||||||Statistical Analysis 4||0.36|-0.63|
71103296|NCT03977155|141714637|SUPERIORITY|Individual BOS-589 dose levels versus placebo were only to be tested if pooled BOS-589 doses versus placebo was significant at p\<0.05.|Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.228||0.4725|TWO_SIDED|95.0|-0.62|0.29|||t test|P-values were calculated from the independent two-sample t test with equal variance.||Statistical Analysis 1||0.29|-0.62|0.4725
71045926|NCT02384941|141599684|SUPERIORITY||Least squares mean difference|-3.3|STANDARD_ERROR_OF_MEAN|0.916|<|0.001|TWO_SIDED|95.0|-5.09|-1.5||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-1.50|-5.09|< 0.001
71045927|NCT02384941|141599685|SUPERIORITY||Least squares mean difference|-0.99|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.5|-0.48||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-0.48|-1.50|< 0.001
71045928|NCT02384941|141599686|SUPERIORITY||Least squares mean difference|2.5|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|1.8|3.3||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||3.3|1.8|< 0.001
71103297|NCT03977155|141714637|SUPERIORITY||Median Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.256|||TWO_SIDED|95.0|-0.71|0.31||||||Statistical Analysis 2||0.31|-0.71|
71103298|NCT03977155|141714637|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.248|||TWO_SIDED|95.0|-0.62|0.37||||||Statistical Analysis 3||0.37|-0.62|
71103299|NCT03977155|141714637|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.262|||TWO_SIDED|95.0|-0.6|0.45||||||Statistical Analysis 4||0.45|-0.60|
71045929|NCT02384941|141599687|SUPERIORITY||Least squares mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.0|-0.5||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-0.5|-1.0|< 0.001
71045930|NCT00484419|141599719|SUPERIORITY_OR_OTHER|||||||0.0061||95.0|||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.||||0.0061
70926314|NCT02547233|141347212|SUPERIORITY||Week 8 AK count ratio|0.3|||<|0.001|TWO_SIDED|95.0|0.25|0.37||Negative binominal regression with treatment group and pooled site as factors and log baseline count as offset variable.|Mantel Haenszel||0.018% relative to vehicle.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||0.37|0.25|<0.001
71045931|NCT00484419|141599719|SUPERIORITY_OR_OTHER|||||||0.109||95.0|||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.||||0.1090
71103300|NCT03977155|141714638|SUPERIORITY|Individual BOS-589 dose levels versus placebo were only to be tested if pooled BOS-589 doses versus placebo was significant at p\<0.05.|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.2||0.5693|TWO_SIDED|95.0|-0.28|0.51|||t test|P-values were calculated from the independent two-sample t test with equal variance.||Statistical Analysis 1||0.51|-0.28|0.5693
71103301|NCT03977155|141714638|SUPERIORITY||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.248|||TWO_SIDED|95.0|-0.35|0.63||||||Statistical Analysis 2||0.63|-0.35|
71103302|NCT03977155|141714638|SUPERIORITY||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-0.33|0.51||||||Statistical Analysis 3||0.51|-0.33|
71103303|NCT03977155|141714638|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.231|||TWO_SIDED|95.0|-0.41|0.51||||||Statistical Analysis 4||0.51|-0.41|
71103304|NCT03977155|141714639|SUPERIORITY|Individual BOS-589 dose levels versus placebo were only to be tested if pooled BOS-589 doses versus placebo was significant at p\<0.05.|Mean Difference (Net)|-7.71|STANDARD_ERROR_OF_MEAN|25.208||0.7603|TWO_SIDED|95.0|-57.76|42.33|||t test|P-values were calculated from the independent two-sample t test with equal variance.||Statistical Analysis 1||42.33|-57.76|0.7603
71103305|NCT03977155|141714639|SUPERIORITY||Mean Difference (Net)|24.0|STANDARD_ERROR_OF_MEAN|29.087|||TWO_SIDED|95.0|-34.22|82.22||||||Statistical Analysis 2||82.22|-34.22|
71103306|NCT03977155|141714639|SUPERIORITY||Mean Difference (Net)|-33.42|STANDARD_ERROR_OF_MEAN|27.285|||TWO_SIDED|95.0|-87.91|21.07||||||Statistical Analysis 3||21.07|-87.91|
71103307|NCT03977155|141714639|SUPERIORITY||Mean Difference (Net)|57.42|STANDARD_ERROR_OF_MEAN|28.174|||TWO_SIDED|95.0|1.16|113.69||||||Statistical Analysis 4||113.69|1.16|
71103308|NCT03977155|141714640|SUPERIORITY|Individual BOS-589 dose levels versus placebo were only to be tested if pooled BOS-589 doses versus placebo was significant at p\<0.05.|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.137||0.2149|TWO_SIDED|95.0|-0.44|0.1|||t test|P-values were calculated from the independent two-sample t test with equal variance.||Statistical Analysis 1||0.10|-0.44|0.2149
71045932|NCT00484419|141599719|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.||||<0.0001
71103309|NCT03977155|141714640|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|95.0|-0.27|0.29||||||Statistical Analysis 2||0.29|-0.27|
71103310|NCT03977155|141714640|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.159|||TWO_SIDED|95.0|-0.64|-0.01||||||Statistical Analysis 3||-0.01|-0.64|
71103311|NCT03977155|141714640|SUPERIORITY||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|0.02|0.65||||||Statistical Analysis 4||0.65|0.02|
71103312|NCT01373281|141714647|SUPERIORITY_OR_OTHER_LEGACY||Vaccine efficacy|56.5|||||TWO_SIDED|95.0|43.8|66.4||||||The statistical methodology was based on the use of the two-sided 95% confidence interval (CI) of the vaccine efficacy (expressed in %). The CI was calculated using the exact method conditional on the total number of cases in both groups (exact method by Breslow \& Day). The vaccine efficacy of the CYD dengue vaccine was considered significant if the lower bound of its 95% CI was greater than 25%.||66.4|43.8|
71103313|NCT01373281|141714650|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|55.4|||||TWO_SIDED|95.0|47.3|62.3||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.||62.3|47.3|
71103314|NCT01373281|141714651|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|57.9|||||TWO_SIDED|95.0|49.0|65.2||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.||65.2|49.0|
71103315|NCT01373281|141714652|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|54.8|||||TWO_SIDED|95.0|46.8|61.7||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.||61.7|46.8|
71103316|NCT00734032|141714690|SUPERIORITY||Ratio|0.514|||<|0.001|TWO_SIDED|95.0|0.449|0.59|||ANCOVA||The point estimate was calculated as adjusted geometric mean ratio of placebo and SB-480848 40 mg. Dunnett adjustment was used for comparison of each dose group to placebo.|||0.590|0.449|<.001
71103317|NCT00734032|141714690|SUPERIORITY||Ratio|0.421|||<|0.001|TWO_SIDED|95.0|0.367|0.483|||ANCOVA||The point estimate was calculated as adjusted geometric mean ratio of placebo and SB-480848 80 mg. Dunnett adjustment was used for comparison of each dose group to placebo.|||0.483|0.367|<.001
71103318|NCT00734032|141714690|SUPERIORITY||Ratio|0.326|||<|0.001|TWO_SIDED|95.0|0.284|0.375|||ANCOVA||The point estimate was calculated as adjusted geometric mean ratio of placebo and SB-480848 160 mg. Dunnett adjustment was used for comparison of each dose group to placebo.|||0.375|0.284|<.001
71045933|NCT00484419|141599720|SUPERIORITY_OR_OTHER|||||||0.0234||95.0|||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.||||0.0234
71009546|NCT01014442|141526648|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0857||||0.2178|TWO_SIDED|95.0|-0.187|0.0265|||Wilcoxon rank sum test|||Free Fraction of Free MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0265|-0.1870|0.2178
71009547|NCT01014442|141526654|SUPERIORITY_OR_OTHER||Difference in rates|-1.8||||1|TWO_SIDED|95.0|-24.9|22.1|||Fisher Exact|||||22.1|-24.9|1.0000
71009548|NCT00724594|141526676|OTHER|||||||0.9||||||not significant|t-test, 2 sided|||Term infant cohort : NAC vs control H0= there will be no difference in resistive index in Middle Cerebral Artery after N-acetylcysteine or saline in the term cohort.||||0.9
71045934|NCT00484419|141599720|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.||||<0.0001
71045935|NCT00484419|141599720|SUPERIORITY_OR_OTHER|||||||0.0011||95.0|||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.||||0.0011
71045936|NCT00484419|141599723|SUPERIORITY_OR_OTHER|||||||0.0077||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0077
71045937|NCT00484419|141599723|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0004
71045938|NCT00484419|141599723|SUPERIORITY_OR_OTHER|||||||0.0483||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0483
71045939|NCT00484419|141599724|SUPERIORITY_OR_OTHER|||||||0.0133||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0133
71045940|NCT00484419|141599724|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0004
71045941|NCT00484419|141599724|SUPERIORITY_OR_OTHER|||||||0.0125||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0125
71009549|NCT00724594|141526676|OTHER|||||||0.9|||||||t-test, 2 sided|||Preterm infant cohort: NAC vs control H0= there will be no difference in resisitive index in MCA after N-acetylcysteine or saline in preterm cohort||||0.9
71009550|NCT00724594|141526677|OTHER|||||||0.9||||||not significant|t-test, 2 sided|||Maternal cohort: NAC versus control l H0= PT will not be different in mothers after NAC or saline||||0.9
71009551|NCT00724594|141526677|OTHER|||||||0.9|||||||t-test, 2 sided|||Infant cohort: NAC versus control H0= prothrombin time will not be different in the infants after NAC or saline||||0.9
71009552|NCT00724594|141526678|OTHER|||||||0.072|||||||t-test, 2 sided|||correcting for gestational age at birth||||0.072
71009553|NCT00724594|141526679|OTHER|||||||0.014|||||||t-test, 2 sided|||||||0.014
71045942|NCT00484419|141599727|SUPERIORITY_OR_OTHER|||||||0.8596||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.8596
71045943|NCT00484419|141599727|SUPERIORITY_OR_OTHER|||||||0.0257||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0257
71045944|NCT00484419|141599727|SUPERIORITY_OR_OTHER|||||||0.1862||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.1862
71045945|NCT00484419|141599728|SUPERIORITY_OR_OTHER|||||||0.7094||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.7094
71045946|NCT00484419|141599728|SUPERIORITY_OR_OTHER|||||||0.1394||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.1394
71009554|NCT02467504|141526687|OTHER|||||||0.53|||||||Chi-squared|||||||0.530
71009555|NCT02467504|141526688|OTHER|||||||0.315|||||||Chi-squared|||||||0.315
71009556|NCT02467504|141526689|OTHER|||||||0.018|||||||Mixed Models Analysis|||||||0.018
71009557|NCT02467504|141526690|OTHER|||||||0.015|||||||Mixed Models Analysis|||||||0.015
71009558|NCT02467504|141526691|OTHER|Chi||||||0.474|||||||Chi-squared|||||||0.474
71009559|NCT02467504|141526692|OTHER|description of Treg cells in CD4+ T cells||||||0.665|||||||Mixed Models Analysis|||||||0.665
71009560|NCT02467504|141526693|OTHER|||||||0.616|||||||Chi-squared|||||||0.616
71045947|NCT00484419|141599728|SUPERIORITY_OR_OTHER|||||||0.4528||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.4528
71045948|NCT00484419|141599730|SUPERIORITY_OR_OTHER|||||||0.0374||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0374
71045949|NCT00484419|141599730|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||<0.0001
71045950|NCT00484419|141599730|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0001
71045951|NCT00484419|141599731|SUPERIORITY_OR_OTHER|||||||0.2701||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.2701
71045952|NCT00484419|141599731|SUPERIORITY_OR_OTHER|||||||0.6117||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.6117
70926315|NCT03524612|141347248|OTHER||||||<|0.0001|||||||Clopper Pearson test|||||||<0.0001
71103319|NCT03809000|141714693|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.1396|TWO_SIDED|80.0|0.56|0.94|||Log Rank|One-sided significance level = 0.10|Reference level = standard ADT|After protocol amendments, the 3-year PFS rate of the standard arm was expected to be 24%. Assuming a hazard ratio of 0.65 (treatment/control) results in a hypothesized 3-year PFS rate of 39.5% on the enhanced ADT arm. A one-sided log-rank test with alpha=0.10 at 80% statistical power was calculated to require 101 events from 170 patients, taking into account expected accrual rate and follow-up time.||0.94|0.56|0.1396
71103320|NCT03360344|141714706|OTHER|non-parametric tests were used as data was not normally distributed.||||||0.48|||||||Wilcoxan signed Rank|||statistical analysis for wrist||||0.48
71103321|NCT03360344|141714706|OTHER|nonparametric test were used as the distribution was not normal.||||||0.99|||||||Wilcoxan Signed Rank|||statistical analysis for forearm||||.99
71103322|NCT03360344|141714707|OTHER|||||||0.001|||||||ANOVA|||statistical analysis for forearm||||.001
71103323|NCT03360344|141714707|OTHER|||||||0.001|||||||ANOVA|||statistical analysis for wrist||||.001
71103324|NCT03360344|141714708|OTHER|||||||0.06|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.06
71103325|NCT03360344|141714709|OTHER|||||||0.01|||||||ANCOVA|||||||.01
70926316|NCT05457647|141347272|OTHER|The accuracy and precision of the theranostic imaging biomarkers, including both the riboflavin score and theranostic score, to predict CXL treatment outcome were determined by calculating the proportion of correctly classified eyes and the positive predictive value respectively.|Proportion|91.0|||||TWO_SIDED|95.0|||||||The study set a minimum threshold of 85 for the the combined use of the theranostic imaging biomarkers' accuracy and precision in predicting the propensity of CXL to halt disease progression at 1 year in the study population.|Accuracy and precision of the combined use of theranostic imaging biomarkers generated by the UV-A device to predict the propensity of CXL in flattening the Kmax value at 12-months.||||
71103326|NCT03360344|141714710|OTHER|||||||0.001|||||||Kruskal-Wallis|||||||.001
71103327|NCT01342666|141714719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1154|STANDARD_ERROR_OF_MEAN|0.9057|<|0.0001|TWO_SIDED|95.0|3.2925|6.9383||We did only one comparison. The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided||We compare de mean difference of the delta (final-basal levels) between groups. The values posted are the difference found in the tomato group in comparison of the control group. The mean represent the increment of HDL-c in the tomato group.|We test the effect of two daily roma tomatoes during one month in HDL-c levels. We estimate the sample size to have a 80% study power.||6.9383|3.2925|<0.0001
71103328|NCT01342666|141714719|SUPERIORITY_OR_OTHER||Slope|5.656|STANDARD_ERROR_OF_MEAN|0.789|<|0.0001|TWO_SIDED|95.0|4.027|7.232||A priori p value of \<0.05|Regression, Linear|Adjusted for adherence, smoking, age, gender, waist to hip ratio, triglycerides, body mass index, exercise, omega 3, alcohol, fish, simple sugars.|Parameters of the model: F= 4.06; r = 0.798; r2 = 0.638; p=0.001|||7.232|4.027|<0.0001
70926317|NCT05457647|141347273|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Assessment of change of Kmax value at 12-months follow-up visit.||||<0.05
71009561|NCT02467504|141526694|OTHER|||||||0.616|||||||Chi-squared|||||||0.616
71103329|NCT04033640|141714731|OTHER||||||<|0.001|||||||K-sample test|The p-value was calculated using a nonparametric k-sample test on the equality of medians.||Comparison of SD Biosensor POC G6PD test results for capillary and venous samples||||<0.001
71103330|NCT00600340|141714734|NON_INFERIORITY|"Null hypothesis: Hazard Ratio (HR) \>= 1.33~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"|Hazard Ratio (HR)|1.042||||0.1983|ONE_SIDED|97.5||1.689||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals|Regression, Cox||HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (interim, stratified).||1.689||0.1983
71103331|NCT00600340|141714734|NON_INFERIORITY|"Null hypothesis: Hazard Ratio (HR) \>= 1.33~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"|Hazard Ratio (HR)|1.018||||0.007|ONE_SIDED|97.5||1.261||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals. Non-inferiority margin was a HR of 1.33.|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (final, stratified).||1.261||0.0070
71103332|NCT00600340|141714734|NON_INFERIORITY|Null hypothesis: Hazard Ratio (HR) \>= 1.33 Based on Cox proportional hazards model.|Hazard Ratio (HR)|1.058||||0.2024|ONE_SIDED|97.5||1.674||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals. Non-inferiority margin was a HR of 1.33.|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (interim, unstratified).||1.674||0.2024
71103333|NCT00600340|141714734|NON_INFERIORITY|Null hypothesis: Hazard Ratio (HR) \>= 1.33 Based on Cox proportional hazards model.|Hazard Ratio (HR)|1.134||||0.0612|ONE_SIDED|97.5||1.386||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals. Non-inferiority margin was a HR of 1.33.|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (final, unstratified).||1.386||0.0612
71009562|NCT02467504|141526695|OTHER|||||||0.2|||||||Chi-squared|||||||0.200
71009563|NCT02467504|141526696|OTHER|||||||0.373|||||||Chi-squared|||||||0.373
71009564|NCT02467504|141526697|OTHER|||||||0.565|||||||Chi-squared|||||||0.565
71009565|NCT02467504|141526698|OTHER|||||||0.221|||||||Wilcoxon (Mann-Whitney)|||||||0.221
71009566|NCT02467504|141526699|OTHER|||||||0.085|||||||Wilcoxon (Mann-Whitney)|||||||0.085
71045953|NCT00484419|141599731|SUPERIORITY_OR_OTHER|||||||0.2007||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.2007
71045954|NCT00484419|141599733|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||<0.0001
71045955|NCT00484419|141599733|SUPERIORITY_OR_OTHER|||||||0.1864||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.1864
71045956|NCT00484419|141599733|SUPERIORITY_OR_OTHER|||||||0.0999||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0999
71045957|NCT00484419|141599734|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||<0.0001
71045958|NCT00484419|141599734|SUPERIORITY_OR_OTHER|||||||0.0566||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0566
71045959|NCT00484419|141599734|SUPERIORITY_OR_OTHER|||||||0.0217||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0217
71009567|NCT02467504|141526700|OTHER|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.740
71009568|NCT02467504|141526701|OTHER|||||||0.881|||||||Mixed Models Analysis|||||||0.881
71009569|NCT02467504|141526702|OTHER|||||||0.422|||||||Mixed Models Analysis|||||||0.422
71009570|NCT02467504|141526703|OTHER|||||||0.055|||||||Wilcoxon (Mann-Whitney)|||||||0.055
71009571|NCT02467504|141526704|OTHER|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
71009572|NCT02467504|141526705|OTHER|||||||0.156|||||||Wilcoxon (Mann-Whitney)|||||||0.156
71009573|NCT00174460|141526707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.991|STANDARD_ERROR_OF_MEAN|0.1067|<|0.001|TWO_SIDED|95.0|0.773|1.21|||ANCOVA|Results from analysis of covariance method (ANCOVA) adjusted for baseline height SDS and target height SDS; Last observation carried forward (LOCF).||Treatment difference||1.210|0.773|<0.001
71009574|NCT00174460|141526708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.415|STANDARD_ERROR_OF_MEAN|0.395|<|0.001|TWO_SIDED|95.0|3.605|5.225|||ANCOVA|Results from ANCOVA adjusted for baseline growth velocity, target height SDS, sex, and age; LOCF.||Treatment difference Month 12||5.225|3.605|<0.001
71009575|NCT00174460|141526708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.884|STANDARD_ERROR_OF_MEAN|0.5327||0.108|TWO_SIDED|95.0|-1.977|0.208|||ANCOVA|Results from ANCOVA adjusted for baseline growth velocity, target height SDS, sex, and age; LOCF.||Treatment difference Month 24||0.208|-1.977|0.108
70926318|NCT05457647|141347274|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Assessment of change of ECD value at 12-months follow-up visit.||||<0.05
71009576|NCT00174460|141526709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.074|STANDARD_ERROR_OF_MEAN|0.7089||0.141|TWO_SIDED|95.0|-2.524|0.376|||ANCOVA|Results from ANCOVA adjusted for baseline growth velocity SDS and target height SDS; LOCF.||Treatment difference||0.376|-2.524|0.141
71009577|NCT00174460|141526710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.54|STANDARD_ERROR_OF_MEAN|0.3661|<|0.001|TWO_SIDED|95.0|3.789|5.291|||ANCOVA|Results from ANCOVA adjusted for baseline height, target height SDS, sex, and age; LOCF.||Treatment difference Month 12||5.291|3.789|<0.001
71009578|NCT00174460|141526710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.064|STANDARD_ERROR_OF_MEAN|0.9822|<|0.001|TWO_SIDED|95.0|2.049|6.08|||ANCOVA|Results from ANCOVA adjusted for baseline height, target height SDS, sex, and age; LOCF.||Treatment difference Month 24||6.080|2.049|<0.001
71009579|NCT00174460|141526711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.719|STANDARD_ERROR_OF_MEAN|0.1606|<|0.001|TWO_SIDED|95.0|0.39|1.047|||ANCOVA|Results from ANCOVA adjusted for baseline height SDS and target height SDS; LOCF.||Treatment difference Month 24||1.047|0.390|<0.001
71009580|NCT00174460|141526712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.497|<|0.001|TWO_SIDED|95.0|-3.73|-1.68|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, age, and sex; LOCF.||Treatment difference Month 12||-1.68|-3.73|<0.001
71009581|NCT00174460|141526712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.758||0.537|TWO_SIDED|95.0|-2.04|1.09|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, age, and sex; LOCF.||Treatment difference Month 24||1.09|-2.04|0.537
71009582|NCT00174460|141526713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.405||0.364|TWO_SIDED|95.0|-1.21|0.46|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, sex, and age; LOCF.||Treatment difference Month 12||0.46|-1.21|0.364
71009583|NCT00174460|141526713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.345||0.506|TWO_SIDED|95.0|-0.94|0.48|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, sex, and age; LOCF.||Treatment difference Month 24||0.48|-0.94|0.506
71045960|NCT04070287|141599843|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
71045961|NCT04070287|141599844|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
71045962|NCT04070287|141599845|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
71045963|NCT04070287|141599846|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
71045964|NCT04070287|141599847|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
71045965|NCT04070287|141599848|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
71045966|NCT00767520|141599850|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.148|||||||Un-stratified log-rank test|||||||0.148
71045967|NCT00720226|141599866|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||Participants demonstrating 5-35% emphysema on baseline CT scan||||0.06
71045968|NCT00720226|141599867|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||Participants with 5-35% emphysema at baseline||||0.55
70926319|NCT05457647|141347275|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Assessment of change of MSER value at 12-months follow-up visit.||||<0.05
70926320|NCT05457647|141347276|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Assessment of change of CDVA value at 12-months follow-up visit.||||<0.05
70926321|NCT05457647|141347277|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Assessment of change of UDVA value at 12-months follow-up visit.||||<0.05
70926322|NCT05457647|141347278|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Assessment of change of CCT value at 12-months follow-up visit.||||<0.05
70926323|NCT05457647|141347279|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively. Bonferroni correction was applied to analysis of exploratory outcome measures of stratification groups.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70926324|NCT05329220|141347308|NON_INFERIORITY|The success criterion for the null hypothesis that ABNCoV2 is inferior to Comirnaty will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.|Geometric Mean Ratio|0.89||||0.635|TWO_SIDED|97.5|0.5|1.57||P-value corresponds to Cohort 1 ABNCoV2 comparison to Cohort 1 Comirnaty|Mixed Models Analysis|A generalized linear model with age and baseline results included as covariates was used to compare between the vaccination groups.||Formal hypothesis testing was performed due to having at least 400 evaluable subjects with primary endpoint data available at baseline and at 2 weeks after trial vaccination. The null hypothesis is that ABNCoV2 is inferior to Comirnaty and will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.||1.57|0.50|0.6350
70926325|NCT05329220|141347308|NON_INFERIORITY|The success criterion for the null hypothesis that ABNCoV2 is inferior to Comirnaty will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.|Geometric Mean Ratio|0.8||||0.0002|TWO_SIDED|97.5|0.7|0.92||P-value corresponds to Cohort 2 ABNCoV2 comparison to Cohort 2 Comirnaty|Mixed Models Analysis|A generalized linear model with age and baseline results included as covariates was used to compare between the vaccination groups.||Formal hypothesis testing was performed due to having at least 400 evaluable subjects with primary endpoint data available at baseline and at 2 weeks after trial vaccination. The null hypothesis is that ABNCoV2 is inferior to Comirnaty and will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.||0.92|0.70|0.0002
70926326|NCT05329220|141347309|NON_INFERIORITY|The success criterion for the null hypothesis that ABNCoV2 is inferior to Comirnaty will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.|Geometric Mean Ratio|0.76||||0.0008|TWO_SIDED|97.5|0.64|0.91||P-value corresponds to Cohort 2 ABNCoV2 comparison to Cohort 2 Comirnaty for Omicron variant BA.4/BA.5|Mixed Models Analysis|A generalized linear model with age and baseline results included as covariates was used to compare between the vaccination groups.||Formal hypothesis testing was performed due to meeting the primary endpoint success criterion in Cohort 2. The null hypothesis is that ABNCoV2 is inferior to Comirnaty and will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.||0.91|0.64|0.0008
70926327|NCT05329220|141347309|NON_INFERIORITY|The success criterion for the null hypothesis that ABNCoV2 is inferior to Comirnaty will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.|Geometric Mean Ratio|0.69|||<|0.0001|TWO_SIDED|97.5|0.59|0.81||P-value corresponds to Cohort 2 ABNCoV2 comparison to Cohort 2 Comirnaty for Omicron Variant XBB.1.5.|Mixed Models Analysis|A generalized linear model with age and baseline results included as covariates was used to compare between the vaccination groups.||Formal hypothesis testing was performed due to meeting the primary endpoint success criterion in Cohort 2. The null hypothesis is that ABNCoV2 is inferior to Comirnaty and will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.||0.81|0.59|<0.0001
70926328|NCT03701399|141347401|SUPERIORITY||Least squares mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.2||0.7581|TWO_SIDED|95.0|-0.47|0.34|||Mixed Models Analysis||Model based summary statistics were from a mixed model with repeated measures, including fixed effects for treatment, randomization stratum (SCA genotype group), visit, treatment-by-visit interaction, and country, baseline score as a covariate|All SCA participants||0.34|-0.47|0.7581
70926329|NCT03701399|141347401|SUPERIORITY||Least square mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.28||0.045|TWO_SIDED|95.0|-1.11|-0.01|||Mixed Models Analysis||Model based summary statistics were from a mixed model with repeated measures, including fixed effects for treatment, randomization stratum (SCA genotype group), visit, treatment-by-visit interaction, and country.|SCA3 genotype participants||-0.01|-1.11|0.0450
71045969|NCT00279955|141599941|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|2.07|STANDARD_DEVIATION|0.292||0.0119|TWO_SIDED|95.0|1.17|3.67|||Regression, Cox||The estimated parameter in a Cox regression model was adjusted by age, gender, New York Heart Association (NYHA) class at 6 month visit, Angiotensin Converting Enzyme (ACE)/Angiotensin Receptor Blocker (ARB) at 6 months, and Diuretics at 6 month.|||3.67|1.17|0.0119
71045970|NCT00279955|141599942|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.9|STANDARD_DEVIATION|0.277||0.0185|TWO_SIDED|95.0|1.11|3.27|||Regression, Cox||The estimated parameter in a Cox regression model was adjusted by age, gender, NYHA class at 6 month visit, ACE/ARB at 6 months, and and at least one day where CRT pacing \<90% in last 21 days of DREP.|||3.27|1.11|0.0185
71045971|NCT00279955|141599943|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.8|STANDARD_DEVIATION|0.311||0.0578|TWO_SIDED|95.0|0.98|3.31|||Regression, Cox||A Cox regression model has been used here, and the estimated parameter has been adjusted by including covariates age, gender, and NYHA class at 6 months.|||3.31|0.98|0.0578
71045972|NCT04179019|141599961|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||The intra-individual, paired, 24h urine aldosterone excretion rate following 2 weeks of amlodipine therapy was compared to the baseline pre-treatment 24h urine aldosterone excretion rate. The null hypothesis was that amlodipine therapy would result in no change in the 24h urine aldosterone excretion rate. Because only 2 participants completed the pilot study, the validity of the results is low.||||0.96
71045973|NCT04179019|141599962|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||The intra-individual, paired, plasma aldosterone concentration following 2 weeks of amlodipine therapy was compared to the baseline pre-treatment aldosterone concentration. The null hypothesis was that amlodipine therapy would result in no change in the plasma aldosterone value. Because only 2 participants completed the pilot study, the validity of the results is low.||||0.29
70926330|NCT02132936|141347423|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.55|||<|0.001|TWO_SIDED|95.0|1.46|4.46|||Mantel Haenszel|||"Mantel-Haenszel odds of treatment success in LEO 90100 group relative to calcipotriol BDP gel group, adjusted for pooled centre and baseline PGA.~Multiple imputation was used to handle missing PGA values."||4.46|1.46|<0.001
71009584|NCT00174460|141526714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|1.188||0.959|TWO_SIDED|95.0|-2.42|2.54|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, sex, and age; LOCF.||Treatment difference Month 12||2.54|-2.42|0.959
71009585|NCT00174460|141526714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|1.065||0.919|TWO_SIDED|95.0|-2.11|2.32|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, sex, and age; LOCF.||Treatment difference Month 24||2.32|-2.11|0.919
71009586|NCT00174460|141526715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.892|STANDARD_ERROR_OF_MEAN|0.8161||0.336|TWO_SIDED|95.0|-3.158|1.374|||ANCOVA|Results from ANCOVA adjusted for baseline volumetric cortical bone mineral density SDS and target height SDS; LOCF.||Treatment difference Month 12||1.374|-3.158|0.336
71009587|NCT00174460|141526715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.717|STANDARD_ERROR_OF_MEAN|0.6027||0.3|TWO_SIDED|95.0|-0.956|2.391|||ANCOVA|Results from ANCOVA adjusted for baseline volumetric cortical bone mineral density SDS and target height SDS; LOCF.||Treatment difference Month 24||2.391|-0.956|0.300
71009588|NCT00174460|141526716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.615|STANDARD_ERROR_OF_MEAN|0.6591|<|0.001|TWO_SIDED|95.0|4.266|6.963|||ANCOVA|Results from ANCOVA adjusted for baseline growth velocity SDS and target height SDS; LOCF.||Treatment difference||6.963|4.266|<0.001
71117588|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.49|||<|0.001|TWO_SIDED|95.0|60.73|88.25||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||88.25|60.73|<0.001
71009589|NCT00174460|141526717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.482|STANDARD_ERROR_OF_MEAN|0.9666||0.653|TWO_SIDED|95.0|-3.558|2.595|||ANCOVA|Results from ANCOVA adjusted for baseline cortical cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 12||2.595|-3.558|0.653
71009590|NCT00174460|141526717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.205|STANDARD_ERROR_OF_MEAN|0.8991||0.251|TWO_SIDED|95.0|-3.701|1.292|||ANCOVA|Results from ANCOVA adjusted for baseline cortical cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 24||1.292|-3.701|0.251
71009591|NCT00174460|141526718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|STANDARD_ERROR_OF_MEAN|1.1499||0.914|TWO_SIDED|95.0|-3.524|3.795|||ANCOVA|Results from ANCOVA adjusted for baseline total cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 12||3.795|-3.524|0.914
71009592|NCT00174460|141526718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.292|STANDARD_ERROR_OF_MEAN|0.4432||0.547|TWO_SIDED|95.0|-0.939|1.522|||ANCOVA|Results from ANCOVA adjusted for baseline total cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 24||1.522|-0.939|0.547
71009593|NCT00174460|141526719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.31|STANDARD_ERROR_OF_MEAN|0.4542||0.007|TWO_SIDED|95.0|1.049|3.572|||ANCOVA|Results from ANCOVA adjusted for baseline muscle cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 12||3.572|1.049|0.007
71009594|NCT00174460|141526719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.626|STANDARD_ERROR_OF_MEAN|0.6536||0.068|TWO_SIDED|95.0|-0.189|3.44|||ANCOVA|Results from ANCOVA adjusted for baseline muscle cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 24||3.440|-0.189|0.068
71009595|NCT00174460|141526722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|STANDARD_ERROR_OF_MEAN|0.5061||0.331|TWO_SIDED|95.0|-0.846|1.965|||ANCOVA|Results from ANCOVA adjusted for baseline strength-strain index SDS and target height SDS; LOCF.||Treatment difference Month 12||1.965|-0.846|0.331
71009596|NCT00174460|141526722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.4703||0.82|TWO_SIDED|95.0|-1.192|1.42|||ANCOVA|Results from ANCOVA adjusted for baseline strength-strain index SDS and target height SDS; LOCF.||Treatment difference Month 24||1.420|-1.192|0.820
71009597|NCT00174460|141526723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.42||0.844|TWO_SIDED|95.0|-0.88|1.05|||ANCOVA|Results from ANCOVA adjusted for baseline hand grip strength SDS and target height SDS; LOCF.||Treatment difference Month 12||1.05|-0.88|0.844
71009598|NCT00174460|141526723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.329||0.519|TWO_SIDED|95.0|-0.52|0.96|||ANCOVA|Results from ANCOVA adjusted for baseline hand grip strength SDS and target height SDS; LOCF.||Treatment difference Month 24||0.96|-0.52|0.519
71009599|NCT00174460|141526726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.998|STANDARD_ERROR_OF_MEAN|0.1095|<|0.001|TWO_SIDED|95.0|0.778|1.219|||Mixed models analysis|Results from repeated measures mixed models analysis adjusted for baseline height SDS, visit, visit\*treatment and target height SDS.||Treatment difference Month 12||1.219|0.778|<0.001
71117589|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.38|||<|0.001|TWO_SIDED|95.0|55.05|83.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.71|55.05|<0.001
70926331|NCT02132936|141347424|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.18|||=|0.001|TWO_SIDED|95.0|1.37|3.47|||Mantel Haenszel|||"Mantel-Haenszel odds of having PASI 75 in LEO 90100 group relative to calcipotriol BDP gel group, adjusted for pooled centre and baseline PGA.~Multiple imputation was used to handle missing data."||3.47|1.37|=0.001
71009600|NCT00174460|141526726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.688|STANDARD_ERROR_OF_MEAN|0.1519|<|0.001|TWO_SIDED|95.0|0.382|0.994|||Mixed models analysis|Results from repeated measures mixed models analysis adjusted for baseline height SDS, visit, visit\*treatment and target height SDS.||Treatment difference Month 24||0.994|0.382|<0.001
71009601|NCT00174460|141526728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.585|STANDARD_ERROR_OF_MEAN|0.3859|<|0.001|TWO_SIDED|95.0|3.806|5.363|||Mixed models analysis|Results from repeated measure mixed models analysis adjusted for baseline height, sex, age, visit, visit\*treatment and target height SDS.||Treatment difference Month 12||5.363|3.806|<0.001
71009602|NCT00174460|141526728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.563|STANDARD_ERROR_OF_MEAN|0.708|<|0.001|TWO_SIDED|95.0|2.134|4.992|||Mixed models analysis|Results from repeated measure mixed models analysis adjusted for baseline height, sex, age, visit, visit\*treatment and target height SDS.||Treatment difference Month 24||4.992|2.134|<0.001
71009603|NCT04047472|141526735|NON_INFERIORITY|Non-inferiority of brolucizumab to aflibercept with respect to change from baseline in BCVA, considering a margin of 4 letters.|LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.16||0.006|TWO_SIDED|90.0|-3.0|0.9|||ANOVA|||||0.9|-3.0|0.006
71009604|NCT04047472|141526736|NON_INFERIORITY|Non-inferiority of brolucizumab to aflibercept with respect to change from baseline in BCVA, considering a margin of 4 letters.|LS mean difference|-1.4|STANDARD_ERROR_OF_MEAN|1.11||0.009|TWO_SIDED|90.0|-3.2|0.5|||ANOVA|||||0.5|-3.2|0.009
71009605|NCT04411472|141526833|SUPERIORITY||Odds Ratio (OR)|1.18||||0.8025|TWO_SIDED|95.0|0.805|1.732|||One-sided p-value|||||1.732|0.805|0.8025
71009606|NCT04411472|141526834|SUPERIORITY||Odds Ratio (OR)|0.54||||0.1824|TWO_SIDED|95.0|0.139|2.131|||One-sided p-value|||||2.131|0.139|0.1824
71009607|NCT04411472|141526835|SUPERIORITY||Odds Ratio (OR)|0.02||||0.008|TWO_SIDED|95.0|0.001|0.405|||One-sided p-value|||||0.405|0.001|0.0080
71009608|NCT04411472|141526836|SUPERIORITY||Odds Ratio (OR)|0.94||||0.3894|TWO_SIDED|95.0|0.606|1.454|||One-sided p-value|||||1.454|0.606|0.3894
71009609|NCT04411472|141526837|SUPERIORITY||Odds Ratio (OR)|0.47||||0.1237|TWO_SIDED|95.0|0.128|1.697|||One-sided p-value|||||1.697|0.128|0.1237
71009610|NCT04411472|141526839|SUPERIORITY||z-score statistic difference proportions|-7.9||||0.019|TWO_SIDED|95.0|-15.4|-0.4||one-sided p-value based on the z-score statistic for the difference in proportions|one-sided p-value|||||-0.4|-15.4|0.019
71009611|NCT04411472|141526840|SUPERIORITY|||||||0.546|||||||One-sided p-value from re-randomization|||Days alive and free of organ support through to Day 28||||0.5460
71009612|NCT04411472|141526840|SUPERIORITY|||||||0.677|||||||One-sided p-value from re-randomization|||Number of days free of MV||||0.6770
71009613|NCT04411472|141526840|SUPERIORITY|||||||0.993|||||||One-sided p-value from re-randomization|||Number of days free of RRT||||0.9930
71009614|NCT04411472|141526840|SUPERIORITY|||||||0.779|||||||One-sided p-value from re-randomization|||Number of days free of vasopressors and inotropes||||0.7790
71009615|NCT04411472|141526841|SUPERIORITY|||||||0.051|||||||One-sided p-value from re-randomization|||Days alive and free of organ support through Day 28||||0.0510
71009616|NCT04411472|141526841|SUPERIORITY|||||||0.013|||||||One-sided p-value from re-randomization|||Number of days free of MV||||0.0130
71009617|NCT04411472|141526841|SUPERIORITY|||||||0.025|||||||One-sided p-value from re-randomization|||Number of days free of RRT||||0.0250
71009618|NCT04411472|141526841|SUPERIORITY|||||||0.073|||||||One-sided p-value from re-randomization|||Number of days free of vasopressors and inotropes||||0.0730
71009619|NCT04411472|141526842|SUPERIORITY|||||||1|||||||One-sided p-value from re-randomization|||Days alive and free of organ support through Day 28||||1.0000
71009620|NCT04411472|141526842|SUPERIORITY|||||||0.979|||||||One-sided p-value from re-randomization|||Number of days free of MV||||0.9790
71009621|NCT04411472|141526842|SUPERIORITY|||||||0.675|||||||One-sided p-value from re-randomization|||Number of days free of RRT||||0.6750
71009622|NCT04411472|141526842|SUPERIORITY|||||||0.031|||||||One-sided p-value from re-randomization|||Number of days free of vasopressors and inotropes||||0.0310
71009623|NCT04411472|141526843|SUPERIORITY|||||||0.545|||||||One-sided p-value from re-randomization|||||||0.5450
71009624|NCT04411472|141526844|SUPERIORITY|||||||0.081|||||||One-sided p-value from re-randomization|||||||0.0810
71009625|NCT04411472|141526845|SUPERIORITY|||||||0.979|||||||One-sided p-value from re-randomization|||||||0.9790
70926332|NCT02132936|141347425|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Log Rank|||||||<0.001
71009626|NCT04411472|141526846|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.6916|TWO_SIDED|95.0|0.806|1.437|||One-sided p-value|||||1.437|0.806|0.6916
71009627|NCT04411472|141526847|SUPERIORITY||Hazard Ratio (HR)|0.47||||0.0628|TWO_SIDED|95.0|0.18|1.234|||One-sided p-value|||||1.234|0.180|0.0628
71009628|NCT04411472|141526848|SUPERIORITY||Hazard Ratio (HR)|0.01|||<|0.0001|TWO_SIDED|95.0|0.001|0.054|||One-sided p-value|||||0.054|0.001|<0.0001
71009629|NCT00982111|141526865|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.9561|TWO_SIDED|95.0|0.84|1.21|||Log Rank|||||1.21|0.84|0.9561
71009630|NCT00982111|141526866|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.96||||0.6647|TWO_SIDED|95.0|0.8|1.16|||Log Rank|||||1.16|0.80|0.6647
71009631|NCT00982111|141526867|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.96||||0.7945|TWO_SIDED|95.0|0.68|1.34|||Cochran-Mantel-Haenszel|||||1.34|0.68|0.7945
71009632|NCT00982111|141526868|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.18||||0.0459|TWO_SIDED|95.0|1.0|1.39|||Log Rank|||||1.39|1.00|0.0459
71009633|NCT03091920|141526958|OTHER|No statistical testing was performed.|LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|6.4|||TWO_SIDED|95.0|-14.2|12.4|||||LS mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1 postdose AM 1 hour||12.4|-14.2|
71009634|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|0.6|STANDARD_ERROR_OF_MEAN|6.0|||TWO_SIDED|95.0|-11.8|12.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 postdose AM 1 hour||12.9|-11.8|
70926333|NCT02132936|141347426|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||Mean change in itch adjusted for pooled centre, baseline PGA and baseline itch. Multiple imputation used for missing data.||||<0.001
70926334|NCT02132936|141347427|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.33|TWO_SIDED||||||ANCOVA|||Mean change in itch adjusted for pooled centre, baseline PGA and baseline itch. Multiple imputation used for missing data.||||=0.33
70926335|NCT02561585|141347428|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.97|TWO_SIDED|95.0|-12.05|11.65||t-test in a baseline adjusted linear model|t-test, 2 sided|t-test, 2 sided on a 5% level||||11.65|-12.05|0.97
70926336|NCT03134196|141347442|SUPERIORITY||Hazard Ratio (HR)|0.78|STANDARD_DEVIATION|0.11|||TWO_SIDED|95.0|0.5|1.06||||||||1.06|0.5|
70926337|NCT03134196|141347443|SUPERIORITY||Hazard Ratio (HR)|0.74|STANDARD_DEVIATION|0.04|||TWO_SIDED|95.0|0.56|0.99||||||||0.99|0.56|
70926338|NCT00753545|141347465|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.35|||<|1e-05|TWO_SIDED|95.0|0.25|0.49|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR \< 1 favours olaparib||0.49|0.25|<0.00001
70926339|NCT00753545|141347466|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.02|TWO_SIDED|95.0|0.55|0.95|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR \< 1 favours olaparib||0.95|0.55|0.02
70926340|NCT00753545|141347470|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-27.1||||0.03185|TWO_SIDED|95.0|-51.9|-2.4|||ANCOVA|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||LS mean \< 0 favours olaparib||-2.4|-51.9|0.03185
70926341|NCT00753545|141347474|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.35|||<|1e-05|TWO_SIDED|95.0|0.25|0.47|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR \< 1 favours olaparib||0.47|0.25|<0.00001
70926342|NCT00753545|141347478|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.23||||0.22|TWO_SIDED|95.0|0.88|1.71|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR \< 1 favours olaparib||1.71|0.88|0.22
70926343|NCT00753545|141347479|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.08||||0.67|TWO_SIDED|95.0|0.75|1.56|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR \< 1 favours olaparib||1.56|0.75|0.67
70926344|NCT00753545|141347480|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.16||||0.38|TWO_SIDED|95.0|0.83|1.64|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR \< 1 favours olaparib||1.64|0.83|0.38
70926345|NCT03839940|141347516|SUPERIORITY||||||<|0.9999|||||||Fisher Exact|||||||< 0.9999
70926346|NCT03839940|141347517|SUPERIORITY|||||||0.3346|||||||Wilcoxon (Mann-Whitney)|||||||0.3346
70926347|NCT03839940|141347533|SUPERIORITY||||||<|0.70361|||||||Fisher Exact|||Female Population.||||< 0.70361
70926348|NCT03839940|141347533|SUPERIORITY||||||<|0.4667|||||||Fisher Exact|||Male population.||||<0.4667
71009635|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-13.9|STANDARD_ERROR_OF_MEAN|8.1|||TWO_SIDED|95.0|-30.6|2.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 postdose AM 4 hour||2.8|-30.6|
71009636|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-15.5|STANDARD_ERROR_OF_MEAN|7.5|||TWO_SIDED|95.0|-31.0|0.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 postdose AM 4 hour||0|-31.0|
71009637|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-9.9|STANDARD_ERROR_OF_MEAN|6.7|||TWO_SIDED|95.0|-23.8|3.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 postdose AM 8 hour||3.9|-23.8|
71009638|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-3.1|STANDARD_ERROR_OF_MEAN|6.2|||TWO_SIDED|95.0|-16.0|9.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 postdose AM 8 hour||9.7|-16.0|
71009639|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-8.8|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-26.2|8.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 predose PM||8.6|-26.2|
71009640|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-3.6|STANDARD_ERROR_OF_MEAN|7.8|||TWO_SIDED|95.0|-19.7|12.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 predose PM||12.6|-19.7|
71009641|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-3.3|STANDARD_ERROR_OF_MEAN|7.5|||TWO_SIDED|95.0|-18.7|12.2||||||Day 1 postdose PM 1 hour||12.2|-18.7|
71009642|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-4.4|STANDARD_ERROR_OF_MEAN|6.9|||TWO_SIDED|95.0|-18.7|9.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 postdose PM||9.9|-18.7|
71009643|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-8.5|STANDARD_ERROR_OF_MEAN|4.7|||TWO_SIDED|95.0|-18.2|1.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 predose AM||1.3|-18.2|
70926349|NCT03839940|141347534|SUPERIORITY||||||<|1|||||||Fisher Exact|||Black or African American population||||<1.0
70926350|NCT03839940|141347534|SUPERIORITY||||||<|1|||||||Fisher Exact|||White population||||<1.0
70926351|NCT03839940|141347535|SUPERIORITY||||||<|1|||||||Fisher Exact|||Not Hispanic or Latino population.||||<1.0
70926352|NCT03839940|141347536|SUPERIORITY||||||<|0.1701|||||||Wilcoxon (Mann-Whitney)|||Female population.||||<0.1701
70926353|NCT03839940|141347536|SUPERIORITY||||||<|0.4811|||||||Wilcoxon (Mann-Whitney)|||Male population.||||<0.4811
70926354|NCT03839940|141347537|SUPERIORITY||||||<|1|||||||Wilcoxon (Mann-Whitney)|||Black or African American Population||||<1.0
70926355|NCT03839940|141347537|SUPERIORITY||||||<|0.5029|||||||Wilcoxon (Mann-Whitney)|||White Population||||<0.5029
70926356|NCT03839940|141347538|SUPERIORITY||||||<|0.295|||||||Wilcoxon (Mann-Whitney)|||Not Hispanic or Latino Population||||<0.2950
71009644|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-5.7|STANDARD_ERROR_OF_MEAN|4.4|||TWO_SIDED|95.0|-14.8|3.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 predose AM||3.3|-14.8|
70850349|NCT01247272|141188459|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.83|||||TWO_SIDED|90.0|101.27|110.61|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||110.61|101.27|
70926357|NCT05210608|141347610|SUPERIORITY||Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|0.55||0.29|TWO_SIDED|95.0|-0.85|2.18||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||We analyzed whether significant changes occurred between baseline and the post-treatment assessment.||2.18|-.85|.29
71009645|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-15.4|STANDARD_ERROR_OF_MEAN|6.1|||TWO_SIDED|95.0|-28.1|-2.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose AM 1 hour||-2.8|-28.1|
71009646|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-9.4|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-21.1|2.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose AM 1 hour||2.3|-21.1|
71009647|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-8.8|STANDARD_ERROR_OF_MEAN|8.1|||TWO_SIDED|95.0|-25.6|7.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose AM 4 hour||7.9|-25.6|
71009648|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-11.2|STANDARD_ERROR_OF_MEAN|7.5|||TWO_SIDED|95.0|-26.7|4.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose AM 4 hour||4.4|-26.7|
71045974|NCT04179019|141599963|SUPERIORITY|||||||0.83|||||||t-test, 2 sided|||The intra-individual, paired, change in plasma aldosterone concentration in response to an acute dose of amlodipine (6h post-dose) was compared to the baseline pre-treatment response to an acute dose of amlodipine. The null hypothesis was that an acute amlodipine dose would result in no acute change in the plasma aldosterone levels. Because only 2 participants completed the pilot study, the validity of the results is low.||||0.83
70850350|NCT03237286|141188467|SUPERIORITY|||||||0.0004|||||||Regression, Linear|||||||.0004
70850351|NCT00948441|141188488|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||t-test, 2 sided|||matched pairs T test to compare infection rates during the two study periods||||0.012
71009649|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-11.7|STANDARD_ERROR_OF_MEAN|5.9|||TWO_SIDED|95.0|-24.0|0.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 predose PM||0.6|-24.0|
71009650|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-7.0|STANDARD_ERROR_OF_MEAN|5.5|||TWO_SIDED|95.0|-18.4|4.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 predose PM||4.4|-18.4|
71009651|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|1.6|STANDARD_ERROR_OF_MEAN|7.1|||TWO_SIDED|95.0|-13.0|16.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose PM 1 hour||16.2|-13.0|
71009652|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|0.7|STANDARD_ERROR_OF_MEAN|6.5|||TWO_SIDED|95.0|-12.9|14.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose PM 1 hour||14.2|-12.9|
71009653|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-4.7|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-16.4|7.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose PM 4 hour||7.1|-16.4|
71009654|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-3.0|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|95.0|-13.9|7.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose PM 4 hour||7.9|-13.9|
71009655|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-4.7|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|-15.8|6.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3 predose AM||6.4|-15.8|
71009656|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-5.8|STANDARD_ERROR_OF_MEAN|5.0|||TWO_SIDED|95.0|-16.0|4.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3 predose AM||4.5|-16.0|
71009657|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|6.4|||TWO_SIDED|95.0|-13.6|13.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3 postdose PM 4 hour||13.1|-13.6|
71009658|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-2.8|STANDARD_ERROR_OF_MEAN|6.0|||TWO_SIDED|95.0|-15.2|9.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3 postdose PM 4 hour||9.6|-15.2|
70926358|NCT05210608|141347610|SUPERIORITY||Mean Difference (Final Values)|1.92|STANDARD_ERROR_OF_MEAN|1.45||0.48|TWO_SIDED|95.0|-3.45|5.79||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||We analyzed whether significant changes occurred between baseline and the 1 month follow up||5.79|-3.45|.48
70926359|NCT05210608|141347611|SUPERIORITY||Mean Difference (Final Values)|37.7|STANDARD_ERROR_OF_MEAN|14.8|=|0.015|TWO_SIDED|95.0|19.9|102.1||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||We analyzed whether there were significant differences in number of total cigarettes smoked per week from baseline to Post-treatment.||102.10|19.90|=0.015
70926360|NCT05210608|141347611|SUPERIORITY||Mean Difference (Final Values)|17.03|STANDARD_ERROR_OF_MEAN|24.69||0.08|TWO_SIDED|95.0|-14.57|142.57|||t-test, 2 sided|||We analyzed whether there were significant differences in number of total cigarettes smoked per week from baseline to 1 month follow-up.||142.57|-14.57|.08
71045975|NCT02610816|141599966|SUPERIORITY|||||||0.04||||||P-values are not adjusted for multiplicity, since a single primary endpoint is analyzed|Mixed Models Analysis|No adjustment of degrees of freedom is needed.||The primary treatment comparison was to compare change in PEESS V2.0 scores of 1FED versus 4FED. The primary null hypothesis was 4FED would be no more effective than 1FED. This was designed as a superiority trial.||||0.04
71045976|NCT02610816|141599967|SUPERIORITY||||||<|0.0001||||||This is a calculated p-value. The threshold for statistical significance is p \<0.05.|Mixed Models Analysis|||||||<0.0001
71045977|NCT02610816|141599967|SUPERIORITY||||||<|0.0001||||||This is a calculated p-value. The threshold for statistical significance is p \<0.05|Mixed Models Analysis|||||||<0.0001
71045978|NCT02610816|141599968|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71045979|NCT02610816|141599971|SUPERIORITY|||||||0.93|||||||Mixed Models Analysis|||||||0.93
71045980|NCT02610816|141599972|SUPERIORITY|||||||0.74|||||||Mixed Models Analysis|||||||0.74
71045981|NCT02610816|141599973|SUPERIORITY|||||||0.36|||||||Mixed Models Analysis|||||||0.36
71045982|NCT01949116|141599975|NON_INFERIORITY|The P-value for the risk difference is from an asymptotic non-inferiority analysis for the proportion (risk) difference with a 15% non-inferiority margin.|Risk Difference (RD)|0.072||||0.0367|ONE_SIDED|90.0||0.134|||Farrington-Manning score (exact)||LDMTX - Placebo|||0.134||0.0367
71045983|NCT01949116|141599976|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.55|TWO_SIDED|95.0|-0.67|0.85|||Wilcoxon (Mann-Whitney)|Stratified by Statin Use (study stratification factor)||||0.85|-0.67|0.55
71045984|NCT03438227|141599989|SUPERIORITY|||||||0.039|||||||Chi-squared|||||||0.039
71103334|NCT00600340|141714735|NON_INFERIORITY|"Null hypothesis: Hazard ratio (HR) \>= 1.33~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"|Hazard Ratio (HR)|1.027||||0.1534|ONE_SIDED|97.5||1.606||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (interim, stratified).||1.606||0.1534
70926361|NCT05210608|141347612|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|3.64||0.9|TWO_SIDED|95.0|-9.86|8.86|||t-test, 2 sided|||We analyzed whether there were significant differences in carbon monoxide ppm from baseline to Post-treatment.||8.86|-9.86|.90
71045985|NCT03438227|141599990|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||||||0.019
71045986|NCT03438227|141599991|SUPERIORITY|||||||0.029|||||||Fisher Exact|||||||0.029
71045987|NCT03438227|141599992|SUPERIORITY|||||||0.029|||||||Fisher Exact|||||||0.029
71045988|NCT03438227|141599993|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||||||0.19
71045989|NCT03438227|141599994|SUPERIORITY|||||||0.194|||||||Fisher Exact|||||||0.194
71045990|NCT03438227|141599995|SUPERIORITY|||||||0.414|||||||Chi-squared|||||||0.414
71045991|NCT03438227|141599996|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
71045992|NCT03438227|141599997|SUPERIORITY|||||||0.571|||||||t-test, 2 sided|||||||0.571
71045993|NCT03438227|141599998|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||||||0.12
71045994|NCT03438227|141599999|SUPERIORITY|||||||0.049|||||||Log Rank|||||||0.049
71045995|NCT03438227|141600000|SUPERIORITY|||||||0.933|||||||t-test, 2 sided|||||||0.933
71045996|NCT03438227|141600001|SUPERIORITY|||||||0.66|||||||Fisher Exact|||||||0.66
71045997|NCT03438227|141600002|SUPERIORITY|||||||0.633|||||||t-test, 2 sided|||||||0.633
71045998|NCT00842530|141600074|SUPERIORITY|The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant only if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|30.2|||||TWO_SIDED|95.0|-13.4|56.6||||||Vaccine efficacy of CYD dengue vaccine: The statistical methodology was based on the use of the two-sided 95% confidence interval (CI) of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups.||56.6|-13.4|
71045999|NCT00842530|141600075|OTHER|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|75.2|||||TWO_SIDED|95.0|-377.0|99.6||||||Vaccine efficacy against severe VCD (IDMC)||99.6|-377|
71046000|NCT00842530|141600075|OTHER|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|50.3|||||TWO_SIDED|95.0|-585.0|96.4||||||Vaccine efficacy of against severe VCD (WHO 1999)||96.4|-585|
71046001|NCT00842530|141600076|SUPERIORITY|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant only if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|41.5|||||TWO_SIDED|95.0|-38.4|74.9||||||Vaccine efficacy:- 28 days Post-Inj. 2 up to Inj. 3||74.9|-38.4|
71046002|NCT00842530|141600076|SUPERIORITY|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant only if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|35.3|||||TWO_SIDED|95.0|3.3|56.5||||||Vaccine efficacy: 28 days Post-Inj. 2 up to end of Active Phase||56.5|3.3|
71046003|NCT00842530|141600082|OTHER|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|33.4|||||TWO_SIDED|95.0|4.1|53.5||||||Vaccine efficacy: 28 days Post-Inj. 1 up to end of Active Phase||53.5|4.1|
71046004|NCT00842530|141600082|OTHER|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|34.9|||||TWO_SIDED|95.0|6.7|54.3||||||Vaccine efficacy: Day 0 up to end of Active Phase||54.3|6.7|
71046005|NCT00486018|141600091|SUPERIORITY_OR_OTHER||Difference in Least Squares means|9.4|||<|0.0001||95.0|6.6|12.2||The Hochberg-Bonferroni multiple comparison procedure was used to adjust for comparisons of the two ranibizumab groups with the sham-injection group to maintain an overall type I error rate of 0.05.|ANOVA|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).||||12.2|6.6|<0.0001
71046006|NCT00486018|141600091|SUPERIORITY_OR_OTHER||Difference in Least Squares means|10.6|||<|0.0001||95.0|7.6|13.6||The Hochberg-Bonferroni multiple comparison procedure was used to adjust for comparisons of the two ranibizumab groups with the sham-injection group to maintain an overall type I error rate of 0.05.|ANOVA|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).||||13.6|7.6|<0.0001
71046007|NCT00486018|141600092|SUPERIORITY_OR_OTHER||Difference in percentage|26.8|||<|0.0001||95.0|15.6|38.0|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||38.0|15.6|<0.0001
71046008|NCT00486018|141600092|SUPERIORITY_OR_OTHER||Difference in percentage|31.3|||<|0.0001||95.0|20.1|42.6|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||42.6|20.1|<0.0001
71046009|NCT00486018|141600093|SUPERIORITY_OR_OTHER||Difference in percentage|4.5||||0.0141||95.0|1.6|9.9|||Fisher Exact||Exact confidence interval based on inverting the exact two-sided score test.|||9.9|1.6|0.0141
71046010|NCT00486018|141600093|SUPERIORITY_OR_OTHER||Difference in percentage|3.0||||0.2815||95.0|-1.5|8.3|||Fisher Exact||Exact confidence interval based on inverting the exact two-sided score test.|||8.3|-1.5|0.2815
71046011|NCT00486018|141600094|SUPERIORITY_OR_OTHER||Difference in percentage|45.5|||<|0.0001||95.0|36.0|55.0|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||55.0|36.0|<0.0001
71046012|NCT00486018|141600094|SUPERIORITY_OR_OTHER||Difference in percentage|40.1|||<|0.0001||95.0|29.9|50.2|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||50.2|29.9|<0.0001
71046013|NCT00486018|141600095|SUPERIORITY_OR_OTHER||Difference in Least Squares means|-148.7|||<|0.0001||95.0|-183.6|-113.8|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline value of central foveal thickness.||||-113.8|-183.6|<0.0001
71046014|NCT00486018|141600095|SUPERIORITY_OR_OTHER||Difference in Least Squares means|-134.8|||<|0.0001||95.0|-172.7|-96.8|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline value of central foveal thickness.||||-96.8|-172.7|<0.0001
71046015|NCT00486018|141600096|SUPERIORITY_OR_OTHER||Difference in Least Squares means|4.1||||0.0214||95.0|0.6|7.6|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Near Activities Subscale score.||||7.6|0.6|0.0214
71046016|NCT00486018|141600096|SUPERIORITY_OR_OTHER||Difference in Least Squares means|6.4||||0.0002||95.0|3.0|9.8|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Near Activities Subscale score.||||9.8|3.0|0.0002
71046017|NCT00486018|141600097|SUPERIORITY_OR_OTHER||Difference in Least Squares means|3.8||||0.0248||95.0|0.5|7.0|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Distance Activities Subscale score.||||7.0|0.5|0.0248
71046018|NCT00486018|141600097|SUPERIORITY_OR_OTHER||Difference in Least Squares means|5.1||||0.0014||95.0|2.0|8.3|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Distance Activities Subscale score.||||8.3|2.0|0.0014
71077845|NCT02913105|141664396|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.99||||0.4344|TWO_SIDED|90.0|0.96|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||1.01|0.96|0.4344
70926362|NCT05210608|141347612|SUPERIORITY||Mean Difference (Final Values)|-12.3|STANDARD_ERROR_OF_MEAN|11.29||0.32|TWO_SIDED|95.0|-49.42|22.42|||t-test, 2 sided|||We analyzed whether there were significant difference in carbon monoxide ppm from baseline to the 1 month follow-up.||22.42|-49.42|.32
70926363|NCT05210608|141347613|SUPERIORITY||Mean Difference (Final Values)|-2.72|STANDARD_ERROR_OF_MEAN|4.36||0.18|TWO_SIDED|95.0|-5.1|19.1|||t-test, 2 sided|||We analyzed whether there were significant differences in working memory scores from baseline to post-treatment.||19.10|-5.10|.18
70926364|NCT05210608|141347613|SUPERIORITY||Mean Difference (Final Values)|-12.64|STANDARD_ERROR_OF_MEAN|5.14||0.18|TWO_SIDED|95.0|-25.38|7.38|||t-test, 2 sided|||We analyzed whether there were significant differences in working memory scores from baseline to the 1 month follow up.||7.38|-25.38|.18
70926365|NCT04908722|141347639|NON_INFERIORITY|Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.15|||||TWO_SIDED|97.5|0.926|1.44||||||Group 1 (1 dose) vs Group 3 (1 dose)||1.440|0.926|
70926366|NCT04908722|141347639|NON_INFERIORITY|Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|0.8||||||97.5|0.641|1.0||||||Group 5 (1 dose) vs Group 3 (1 dose)||1.00|0.641|
70926367|NCT04908722|141347639|NON_INFERIORITY|Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.07|||||TWO_SIDED|97.5|0.844|1.356||||||Group 2 (1 dose) vs Group 3 (1 dose)||1.356|0.844|
70926368|NCT04908722|141347639|NON_INFERIORITY|Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|0.94|||||TWO_SIDED|97.5|0.742|1.193||||||Group 4 (1 dose) vs Group 3 (1 dose)||1.193|0.742|
70926369|NCT04908722|141347639|NON_INFERIORITY|Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|0.81|||||TWO_SIDED|97.5|0.648|1.007||||||Group 6 (1 dose) vs Group 3 (1 dose)||1.007|0.648|
70926370|NCT04908722|141347640|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|2.53|||||TWO_SIDED|97.5|1.992|3.207||||||Group 1 (2 doses) vs Group 3 (1 dose)||3.207|1.992|
70926371|NCT04908722|141347640|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.41|||||TWO_SIDED|97.5|1.088|1.815||||||Group 1 (2 doses) vs Group 3 (2 doses)||1.815|1.088|
71046019|NCT02409329|141600104|SUPERIORITY|We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.313||||0.0493|TWO_SIDED|95.0|-0.61|-0.017||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|6-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. For the HbA1c model, we allowed for a three-way interaction between time, treatment group, and baseline HbA1c because there was descriptive evidence that the effect was modified by baseline HbA1c values. Multiply imputed data (m=1,000) using chained equations.||-0.017|-0.610|.0493
71046020|NCT02409329|141600104|SUPERIORITY|We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.07||||0.26|TWO_SIDED|95.0|-0.38|0.24||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|15-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. For the HbA1c model, we allowed for a three-way interaction between time, treatment group, and baseline HbA1c because there was descriptive evidence that the effect was modified by baseline HbA1c values. Multiply imputed data (m=1,000) using chained equations.||0.240|-0.380|0.260
71046021|NCT02409329|141600105|SUPERIORITY|We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.406|||<|0.001|TWO_SIDED|95.0|0.196|0.615||A priori threshold p\<.05.|Wald statistic|Adjusted for baseline values with cubic splines (3 knots).|6-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||0.615|0.196|<.001
71046022|NCT02409329|141600105|SUPERIORITY|We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.21||||0.003|TWO_SIDED|95.0|-0.031|0.45||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|15-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. For the HbA1c model, we allowed for a three-way interaction between time, treatment group, and baseline HbA1c because there was descriptive evidence that the effect was modified by baseline HbA1c values. Multiply imputed data (m=1,000) using chained equations.||0.450|-0.031|0.003
70926372|NCT04908722|141347640|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.79|||||TWO_SIDED|97.5|1.408|2.265||||||Group 5 (2 doses) vs Group 3 (1 dose)||2.265|1.408|
70926373|NCT04908722|141347640|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|0.99|||||TWO_SIDED|97.5|0.769|1.282||||||Group 5 (2 doses) vs Group 3 (2 doses)||1.282|0.769|
70926374|NCT04908722|141347640|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|2.37|||||TWO_SIDED|97.5|1.829|3.007||||||Group 2 (2 doses) vs Group 3 (1 dose)||3.007|1.829|
70926375|NCT04908722|141347640|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.32|||||TWO_SIDED|97.5|1.0|1.739||||||Group 2 (2 doses) vs Group 3 (2 doses)||1.739|1.000|
71009659|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-6.2|STANDARD_ERROR_OF_MEAN|4.4|||TWO_SIDED|95.0|-15.5|3.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 4 predose AM||3.0|-15.5|
71103335|NCT00600340|141714735|NON_INFERIORITY|"Null hypothesis: Hazard ratio (HR) \>= 1.33~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"|Hazard Ratio (HR)|1.035||||0.0085|ONE_SIDED|97.5||1.273||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (final, stratified).||1.273||0.0085
71103336|NCT00600340|141714735|NON_INFERIORITY|Null hypothesis: Hazard Ratio (HR) \>= 1.33 Based on Cox proportional hazards model.|Hazard Ratio (HR)|1.058||||0.1778|ONE_SIDED|97.5||1.623||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (interim, unstratified).||1.623||0.1778
71103337|NCT00600340|141714735|NON_INFERIORITY|Null hypothesis: Hazard Ratio (HR) \>= 1.33 Based on Cox proportional hazards model.|Hazard Ratio (HR)|1.126||||0.049|ONE_SIDED|97.5||1.37||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (final, unstratified).||1.37||0.049
71103338|NCT00600340|141714741|SUPERIORITY|OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.33|0.67||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|Odds Ratio (OR) of objective response and Cochran-Mantel-Haenszel (CMH) test (stratified)||0.67|0.33|< 0.0001
71103339|NCT00600340|141714741|SUPERIORITY||Risk Difference (RD)|-17.0|||||TWO_SIDED|95.0|-24.0|-9.0|||||Difference calculated as ORR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, units in percent.|Difference in ORR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-9|-24|
71103340|NCT00600340|141714741|SUPERIORITY|OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.43||||0.0006|TWO_SIDED|95.0|0.27|0.7||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|OR of disease control and CMH test (stratified)||0.70|0.27|0.0006
71103341|NCT00600340|141714741|SUPERIORITY||Risk Difference (RD)|-12.0|||||TWO_SIDED|95.0|-18.0|-6.0|||||Difference calculated as the DCR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, units in percent.|Difference in DCR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-6|-18|
71103342|NCT00600340|141714742|SUPERIORITY|OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.31|0.65||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|OR of objective response and CMH test (stratified)||0.65|0.31|< 0.0001
71103343|NCT00600340|141714742|SUPERIORITY||Risk Difference (RD)|-18.0|||||TWO_SIDED|95.0|-26.0|-10.0|||||Difference calculated as ORR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, units in percent.|Difference in ORR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-10|-26|
71117590|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|73.52|||<|0.001|TWO_SIDED|95.0|59.65|87.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||87.38|59.65|<0.001
71117591|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.36|||<|0.001|TWO_SIDED|95.0|54.01|82.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||82.71|54.01|<0.001
70926376|NCT04908722|141347640|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|2.2|||||TWO_SIDED|97.5|1.697|2.841||||||Group 4 (2 doses) vs Group 3 (1 dose)||2.841|1.697|
71103344|NCT00600340|141714742|SUPERIORITY|OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.39||||0.0003|TWO_SIDED|95.0|0.24|0.65||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|OR of disease control and CMH test (stratified)||0.65|0.24|0.0003
71103345|NCT00600340|141714742|SUPERIORITY||Risk Difference (RD)|-12.0|||||TWO_SIDED|95.0|-19.0|-6.0|||||Difference calculated as the DCR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, units in percent.|Difference in DCR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-6|-19|
71103346|NCT00600340|141714743|SUPERIORITY|OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.31|0.63||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|OR of objective response and CMH test (stratified)||0.63|0.31|< 0.0001
71103347|NCT00600340|141714743|SUPERIORITY||Risk Difference (RD)|-20.0|||||TWO_SIDED|95.0|-28.0|-11.0|||||Difference calculated as ORR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, units in percent.|Difference in ORR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-11|-28|
71103348|NCT00600340|141714743|SUPERIORITY||Odds Ratio (OR)|0.43||||0.0006|TWO_SIDED|95.0|0.27|0.7||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|OR of disease control and CMH test (stratified)||0.70|0.27|0.0006
71103349|NCT00600340|141714743|SUPERIORITY||Risk Difference (RD)|-12.0|||||TWO_SIDED|95.0|-18.0|-6.0|||||Difference calculated as DCR in Bevacizumab Plus Capecitabine minus DCR in Bevacizumab plus Paclitaxel, units in percent.|Difference in DCR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-6|-18|
71103350|NCT00600340|141714744|SUPERIORITY||Odds Ratio (OR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.29|0.6||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|OR of objective response and CMH test (stratified)||0.60|0.29|< 0.0001
71103351|NCT00600340|141714744|SUPERIORITY||Risk Difference (RD)|-21.0|||||TWO_SIDED|95.0|-30.0|-13.0|||||Difference calculated as ORR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, unit in percent.|Difference in ORR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-13|-30|
71103352|NCT00600340|141714744|SUPERIORITY|OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.39||||0.0003|TWO_SIDED|95.0|0.24|0.65||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|OR of disease control and CMH test (stratified)||0.65|0.24|0.0003
71103353|NCT00600340|141714744|SUPERIORITY||Risk Difference (RD)|-12.0|||||TWO_SIDED|95.0|-19.0|-6.0|||||Difference calculated as DCR in Bevacizumab Plus Capecitabine minus DCR in Bevacizumab plus Paclitaxel, unit in percent.|Difference in DCR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-6|-19|
71103354|NCT00600340|141714745|SUPERIORITY|HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|1.32||||0.0066|TWO_SIDED|95.0|1.08|1.61|||Log Rank|Two-sided log-rank test adjusted by stratification factors at randomization|HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for PFS (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||1.61|1.08|0.0066
70926377|NCT04908722|141347640|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.22|||||TWO_SIDED|97.5|0.928|1.606||||||Group 4 (2 doses) vs Group 3 (2 doses)||1.606|0.928|
71009660|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-8.1|STANDARD_ERROR_OF_MEAN|4.1|||TWO_SIDED|95.0|-16.6|0.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 4 predose AM||0.5|-16.6|
71009661|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-1.7|STANDARD_ERROR_OF_MEAN|4.9|||TWO_SIDED|95.0|-11.8|8.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 5 predose AM||8.4|-11.8|
71009662|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-10.0|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-19.4|-0.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 5 predose AM||-0.7|-19.4|
71009663|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-6.7|STANDARD_ERROR_OF_MEAN|5.5|||TWO_SIDED|95.0|-18.1|4.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 6 predose AM||4.7|-18.1|
71009664|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-4.3|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-14.8|6.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 6 predose AM||6.3|-14.8|
71009665|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|1.0|STANDARD_ERROR_OF_MEAN|6.3|||TWO_SIDED|95.0|-12.2|14.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7 predose AM||14.1|-12.2|
71009666|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-3.8|STANDARD_ERROR_OF_MEAN|5.9|||TWO_SIDED|95.0|-16.0|8.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7 predose AM||8.4|-16.0|
71009667|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-3.0|STANDARD_ERROR_OF_MEAN|5.8|||TWO_SIDED|95.0|-15.1|9.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7 postdose AM 1 hour||9.1|-15.1|
71009668|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-6.4|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.0|-17.6|4.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7 postdose AM 1 hour||4.8|-17.6|
71009669|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-9.5|STANDARD_ERROR_OF_MEAN|6.4|||TWO_SIDED|95.0|-22.7|3.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7 postdose AM 4 hour||3.7|-22.7|
71009670|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-17.2|STANDARD_ERROR_OF_MEAN|5.9|||TWO_SIDED|95.0|-29.5|-5.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7 postdose AM 4 hour||-5.0|-29.5|
71009671|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-11.7|STANDARD_ERROR_OF_MEAN|6.2|||TWO_SIDED|95.0|-24.4|1.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 predose AM||1.1|-24.4|
71009672|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-8.3|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-20.2|3.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 predose AM||3.5|-20.2|
71009673|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-13.4|STANDARD_ERROR_OF_MEAN|7.1|||TWO_SIDED|95.0|-28.1|1.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 postdose AM 1 hour||1.4|-28.1|
71009674|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-10.3|STANDARD_ERROR_OF_MEAN|6.6|||TWO_SIDED|95.0|-24.0|3.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 postdose AM 1 hour||3.3|-24.0|
71009675|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-10.1|STANDARD_ERROR_OF_MEAN|8.2|||TWO_SIDED|95.0|-27.0|6.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 postdose AM 4 hour||6.9|-27.0|
71009676|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-4.6|STANDARD_ERROR_OF_MEAN|7.6|||TWO_SIDED|95.0|-20.4|11.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 postdose AM 4 hour||11.1|-20.4|
71009677|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-4.2|STANDARD_ERROR_OF_MEAN|7.3|||TWO_SIDED|95.0|-19.5|11.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 predose PM||11.0|-19.5|
71009678|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|6.8|||TWO_SIDED|95.0|-15.4|12.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 predose PM||12.8|-15.4|
70926378|NCT04908722|141347640|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.7|||||TWO_SIDED|97.5|1.348|2.148||||||Group 6 (2 doses) vs Group 3 (1 dose)||2.148|1.348|
71046023|NCT02409329|141600106|SUPERIORITY|We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.54||||0.376|TWO_SIDED|95.0|-0.012|1.09||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|6-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||1.090|-0.012|0.376
71046024|NCT02409329|141600106|SUPERIORITY|We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.278||||0.434|TWO_SIDED|95.0|-0.319|0.875||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|15-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||0.875|-0.319|0.434
71046025|NCT02409329|141600107|SUPERIORITY|We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.399||||0.0012|TWO_SIDED|95.0|0.16|0.637||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|6-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations||0.637|0.160|0.0012
71046026|NCT02409329|141600107|SUPERIORITY|We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.152||||0.003|TWO_SIDED|95.0|-0.121|0.426||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|15-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||0.426|-0.121|0.003
71046027|NCT02409329|141600108|SUPERIORITY|We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.061||||0.632|TWO_SIDED|95.0|-0.218|0.095||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|6-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||0.095|-0.218|0.632
71046028|NCT02409329|141600108|SUPERIORITY|We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.005||||0.572|TWO_SIDED|95.0|-0.202|1.1||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|15-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||1.100|-0.202|0.572
71046029|NCT02409329|141600109|SUPERIORITY|We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|369.0||||0.703|TWO_SIDED|95.0|-142.0|881.0||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|6-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||881|-142|0.703
71046030|NCT02409329|141600109|SUPERIORITY|We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|26.0||||0.465|TWO_SIDED|95.0|-459.0|511.0||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|15-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||511|-459|0.465
71077846|NCT02913105|141664396|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.99||||0.639|TWO_SIDED|90.0|0.97|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||1.02|0.97|0.6390
70926379|NCT04908722|141347640|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|0.95|||||TWO_SIDED|97.5|0.736|1.217||||||Group 6 (2 doses) vs Group 3 (2 doses)||1.217|0.736|
71009679|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-12.7|STANDARD_ERROR_OF_MEAN|5.0|||TWO_SIDED|95.0|-23.0|-2.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 9 predose AM||-2.5|-23.0|
71009680|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-5.2|STANDARD_ERROR_OF_MEAN|4.6|||TWO_SIDED|95.0|-14.7|4.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 9 predose AM||4.3|-14.7|
71009681|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-8.0|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|-19.0|2.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 10 predose AM||2.9|-19.0|
71009682|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-3.8|STANDARD_ERROR_OF_MEAN|4.9|||TWO_SIDED|95.0|-14.0|6.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 10 predose||6.3|-14.0|
71009683|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-16.1|STANDARD_ERROR_OF_MEAN|7.2|||TWO_SIDED|95.0|-31.0|-1.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 11 predose AM||-1.2|-31.0|
71009684|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-8.3|STANDARD_ERROR_OF_MEAN|6.7|||TWO_SIDED|95.0|-22.1|5.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 11 predose AM||5.6|-22.1|
71046031|NCT02409329|141600110|SUPERIORITY|Testing superiority of REACH only relative to control. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.75|||||TWO_SIDED|95.0|-1.38|-0.12|||||6-month point estimate|To evaluate if REACH only and REACH+FAMS had similar effects on HbA1c relative to control, we subsetted to participants with baseline HbA1c greater than or equal to 8.5% to maximize our power for these analyses. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||-0.12|-1.38|
71046032|NCT02409329|141600110|SUPERIORITY|Testing superiority of REACH only relative to control. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.31|||||TWO_SIDED|95.0|-1.0|0.39|||||12-month point estimate|To evaluate if REACH only and REACH+FAMS had similar effects on HbA1c relative to control, we subsetted to participants with baseline HbA1c greater than or equal to 8.5% to maximize our power for these analyses. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||0.39|-1.00|
71046033|NCT02409329|141600110|SUPERIORITY|Testing superiority of REACH\_FAMS relative to control. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.65|||||TWO_SIDED|95.0|-1.26|-0.05|||||6-month point estimate|To evaluate if REACH only and REACH+FAMS had similar effects on HbA1c relative to control, we subsetted to participants with baseline HbA1c greater than or equal to 8.5% to maximize our power for these analyses. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||-0.05|-1.26|
71046034|NCT02409329|141600110|SUPERIORITY|Testing superiority of REACH+FAMS relative to control. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.31|||||TWO_SIDED|95.0|-0.96|0.51|||||12-month point estimate|To evaluate if REACH only and REACH+FAMS had similar effects on HbA1c relative to control, we subsetted to participants with baseline HbA1c greater than or equal to 8.5% to maximize our power for these analyses. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||0.51|-0.96|
71046035|NCT00788593|141600125|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|1.023||||0.228|TWO_SIDED|95.0|-0.656|2.701|||ANCOVA|||Treatment difference and 95 percent (%) confidence interval (CI) was based on LS mean from analysis of covariance (ANCOVA) which included participant as random effect, treatment, period and sequence as fixed effects, and placebo baseline CFA value as covariate.||2.701|-0.656|0.228
71046036|NCT00788593|141600126|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71046037|NCT00788593|141600126|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71009685|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-3.4|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.0|-14.6|7.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 12 predose AM||7.9|-14.6|
71009686|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-5.5|STANDARD_ERROR_OF_MEAN|5.0|||TWO_SIDED|95.0|-15.9|4.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 12 predose AM||4.9|-15.9|
71009687|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-11.9|STANDARD_ERROR_OF_MEAN|4.9|||TWO_SIDED|95.0|-22.1|-1.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 predose AM||-1.7|-22.1|
71009688|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-6.5|STANDARD_ERROR_OF_MEAN|4.6|||TWO_SIDED|95.0|-16.0|2.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 predose AM||2.9|-16.0|
71009689|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-14.3|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.0|-25.4|-3.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 postdose AM 1 hour||-3.2|-25.4|
71009690|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-11.8|STANDARD_ERROR_OF_MEAN|5.0|||TWO_SIDED|95.0|-22.1|-1.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 postdose AM 1 hour||-1.5|-22.1|
71009691|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-11.7|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-29.0|5.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 postdose AM 4 hour||5.6|-29.0|
71009692|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-9.8|STANDARD_ERROR_OF_MEAN|7.7|||TWO_SIDED|95.0|-25.9|6.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 postdose AM 4 hour||6.2|-25.9|
71009693|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-11.3|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.0|-22.4|-0.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 postdose PM||-0.1|-22.4|
71009694|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-9.9|STANDARD_ERROR_OF_MEAN|5.0|||TWO_SIDED|95.0|-20.2|0.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 predose PM||0.4|-20.2|
71009695|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-5.8|STANDARD_ERROR_OF_MEAN|7.8|||TWO_SIDED|95.0|-22.0|10.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14 predose AM||10.5|-22.0|
70926380|NCT02319759|141347650|SUPERIORITY||Percent difference|39.7|||<|0.001|TWO_SIDED|95.0|25.3|54.1|||Cochran-Mantel-Haenszel|||||54.1|25.3|<0.001
71009696|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-6.1|STANDARD_ERROR_OF_MEAN|7.3|||TWO_SIDED|95.0|-21.1|9.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14 predose AM||9.0|-21.1|
71009697|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-8.1|STANDARD_ERROR_OF_MEAN|6.6|||TWO_SIDED|95.0|-21.7|5.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 15 / Discharge||5.6|-21.7|
71009698|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-5.0|STANDARD_ERROR_OF_MEAN|6.1|||TWO_SIDED|95.0|-17.7|7.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 15 / Discharge||7.6|-17.7|
71009699|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|4.8|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-7.0|16.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 21 / Follow-up||16.7|-7.0|
71046038|NCT00788593|141600127|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71046039|NCT00788593|141600127|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
70926381|NCT02319759|141347651|SUPERIORITY||Percentage (%) Difference|66.1|||<|0.001|TWO_SIDED|95.0|53.8|78.4|||Cochran-Mantel-Haenszel|||||78.4|53.8|<0.001
71009700|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|5.2|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|-5.8|16.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 21 / Follow-up||16.2|-5.8|
71009701|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|5.5|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-11.7|22.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 42 / End of Trial||22.6|-11.7|
71009702|NCT03091920|141526958|OTHER|No statistical testing was performed.|Least squares mean difference|-4.5|STANDARD_ERROR_OF_MEAN|7.7|||TWO_SIDED|95.0|-20.4|11.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 42 / End of Trial||11.4|-20.4|
71009703|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-2.6|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-8.9|3.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 1 hour||3.8|-8.9|
71009704|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-2.0|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-8.4|4.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 1 hour||4.5|-8.4|
71009705|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-2.9|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-9.2|3.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 4 hour||3.4|-9.2|
71009706|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-7.1|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-13.5|-0.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 4 hour||-0.6|-13.5|
71009707|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-5.5|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-11.5|0.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 8 hour||0.6|-11.5|
71046040|NCT03020719|141600130|SUPERIORITY||Mean Difference (Final Values)|-0.081||||0.2521|TWO_SIDED|95.0|-0.221|0.059|||Mixed Models Analysis|Model adjusted for randomization strata: sex, baseline age (\< 6 years, ≥ 6 years), and baseline weight-for-age z-score category (\< -0.52, ≥ -0.52).|Model incorporates Week 12 weight-for-age z-score, assumes unstructured covariance for within-subject measurements, and includes a subject-level random intercept.|||0.059|-0.221|0.2521
71009708|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-4.6|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-10.8|1.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 8 hour||1.5|-10.8|
71046041|NCT03020719|141600131|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.089|TWO_SIDED|95.0|-0.18|0.01|||Mixed Models Analysis|Model adjusted for randomization strata: sex, baseline age (\<6 years, ≥6 years), and baseline weight-for-age z-score category (\< -0.52, ≥-0.52).|Model incorporates Week 12 measurements, assumes unstructured covariance for within-subject measurements, and includes a subject-level random intercept.|||0.01|-0.18|0.0890
71009709|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-3.6|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-9.4|2.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, pre-dose PM||2.2|-9.4|
71009710|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-2.1|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-8.0|3.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, pre-dose PM||3.7|-8.0|
71009711|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-5.0|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-13.8|3.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose PM 1 hour||3.9|-13.8|
71009712|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-2.7|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-11.7|6.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose PM 1 hour||6.2|-11.7|
71009713|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-4.4|STANDARD_ERROR_OF_MEAN|2.5|||TWO_SIDED|95.0|-9.7|0.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose AM||0.9|-9.7|
71046042|NCT03020719|141600132|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.573|TWO_SIDED|95.0|-0.28|0.15|||Mixed Models Analysis|Model adjusted from randomization strata: sex, baseline age (\<6 years, ≥6 years), and baseline weight-for-age z-score category (\< -0.52, ≥-0.52).|Model incorporates Week 12 measurements, assumes unstructured covariance for within-subject measurements, and includes a subject-level random intercept.|||0.15|-0.28|0.5730
71046043|NCT03020719|141600133|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.4259|TWO_SIDED|95.0|-0.17|0.4|||Mixed Models Analysis|Model adjusted for randomization strata: sex, baseline age (\<6 years, ≥6 years), and baseline weight-for-age z-score category (\< -0.52, ≥-0.52).|Model incorporates Week 12 measurements, assumes unstructured covariance for within-subject measurements, and includes a subject-level random intercept.|||0.40|-0.17|0.4259
71046044|NCT03020719|141600134|SUPERIORITY||Mean Difference (Final Values)|-0.55||||0.4666|TWO_SIDED|95.0|-2.06|0.96|||ANCOVA|Model adjusted for randomization strata: sex, baseline age (\<6 years, ≥6 years), and baseline weight-for-age z-score category (\< -0.52, ≥-0.52).||||0.96|-2.06|0.4666
71046045|NCT03020719|141600135|SUPERIORITY||Difference in % of Participants with AE|0.0||||1|TWO_SIDED|95.0|-13.6|13.6|||Fisher Exact||95% CI calculated using the Newcombe-Wilson method without continuity correction.|||13.6|-13.6|1.0000
71046046|NCT03020719|141600135|SUPERIORITY||Difference in % of Participants with SAE|-13.3||||0.1945|TWO_SIDED|95.0|-30.5|2.9|||Fisher Exact||95% CI calculated using the Newcombe-Wilson method without continuity correction.|||2.9|-30.5|0.1945
71046047|NCT03020719|141600136|SUPERIORITY||Rate Ratio|1.21||||0.1087|TWO_SIDED|95.0|0.96|1.52|||Poisson Regression|||Rate Ratio for Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in months. The total number of follow-up months of all participants (not per participant) in the trial was as follows: in the GSH group was 179.22 and in the Placebo group was 177.19.||1.52|0.96|0.1087
71009714|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-3.1|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|95.0|-8.5|2.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose AM||2.2|-8.5|
71009715|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-6.7|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-13.1|-0.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 1 hour||-0.3|-13.1|
71009716|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-5.3|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-11.8|1.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 1 hour||1.2|-11.8|
71009717|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-5.4|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-14.2|3.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 4 hour||3.5|-14.2|
71009718|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-8.5|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-17.5|0.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 4 hour||0.5|-17.5|
71009719|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-5.7|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-11.6|0.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose PM||0.2|-11.6|
71046048|NCT03020719|141600136|SUPERIORITY||Rate Ratio|0.12||||0.0122|TWO_SIDED|95.0|0.01|0.67|||Poisson Regression|||Rate Ratio for Serious Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in months. The total number of follow-up months of all participants (not per participant) in the trial was as follows: in the GSH group was 179.22 and in the Placebo group was 177.19.||0.67|0.01|0.0122
71046049|NCT00710749|141600146|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44||95.0|||||Wilcoxon signed rank test|||||||0.44
71046050|NCT00710749|141600146|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||Wilcoxon signed rank test|||||||0.0001
70926382|NCT02319759|141347652|SUPERIORITY||Least Square Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.471|-0.148|||MMRM|MMRM stands for Mixed-effects Model Repeated Measures||||-0.148|-0.471|<0.001
71009720|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-4.6|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-10.6|1.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose PM||1.5|-10.6|
71009721|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|-7.4|6.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 1 hour||6.4|-7.4|
71009722|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-2.3|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-9.3|4.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 1 hour||4.7|-9.3|
71009723|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-2.4|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-9.4|4.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 4 hour||4.6|-9.4|
71009724|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-1.5|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-8.7|5.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 4 hour||5.6|-8.7|
71046051|NCT00710749|141600146|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
71046052|NCT04843566|141600176|SUPERIORITY|||||||0.04|||||||Fisher Exact|||Infection||||0.04
70926383|NCT04213872|141347694|OTHER|||||||0.01|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value CogPCI 25.4 (14.2) 17.3 (10.5) \*-8.1 (3.7) .01~\*reduction in scores indicate improvement."||||.01
71009725|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|0.2|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-6.2|6.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, pre-dose AM||6.7|-6.2|
71009726|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-6.2|6.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, pre-dose AM||6.8|-6.2|
70926384|NCT04213872|141347695|OTHER|||||||0.03|||||||t-test, 2 sided|||Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value CogPCA 16.0 (5.1) 19.2 (5.3) 3.2 (0.2) .03||||.03
70926385|NCT04213872|141347696|OTHER|||||||0.04|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value CogQOL 3.7 (3.8) 1.8 (2.2) \*-1.9 (1.6) .04~\*lower scores signifying better outcomes."||||.04
71009727|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|1.5|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-6.4|9.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, post-dose PM 4 hour||9.4|-6.4|
71009728|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|3.9|||TWO_SIDED|95.0|-9.3|6.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, post-dose PM 4 hour||6.8|-9.3|
71009729|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-4.3|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-10.0|1.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 4, pre-dose AM||1.4|-10.0|
71009730|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-4.5|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-10.3|1.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 4, pre-dose AM||1.3|-10.3|
71009731|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-2.4|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-8.2|3.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 5, pre-dose AM||3.3|-8.2|
71046053|NCT04843566|141600176|SUPERIORITY|||||||0.3|||||||Fisher Exact|||Urinary retention||||0.30
71046054|NCT04843566|141600176|SUPERIORITY|||||||0.31|||||||Fisher Exact|||Bleeding requiring intervention||||0.31
71046055|NCT04843566|141600177|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||Immediately following biopsy - Pain||||0.002
71046056|NCT04843566|141600177|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||Immediately following biopsy - Discomfort||||0.05
71046057|NCT04843566|141600177|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||7-day post biopsy - Pain||||<0.0001
71046058|NCT04843566|141600177|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||7-day post biopsy - Discomfort||||0.07
71046059|NCT04843566|141600178|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||||||0.23
71046060|NCT04843566|141600179|SUPERIORITY|||||||0.59|||||||Chi-squared|||Gleason grade \>=2||||0.59
71046061|NCT04843566|141600180|SUPERIORITY|||||||0.04|||||||Fisher Exact|||Infection||||0.04
71046062|NCT04843566|141600180|SUPERIORITY|||||||0.3|||||||Fisher Exact|||Urinary retention||||0.30
71046063|NCT04843566|141600180|SUPERIORITY|||||||0.31|||||||Fisher Exact|||Bleeding requiring intervention||||0.31
71046064|NCT02516410|141600262|SUPERIORITY||Least squares (LS) mean difference|1.2|||=|0.1176|TWO_SIDED|95.0|-0.3|2.6|||Mixed-effect repeated measure (MMRM)|||||2.6|-0.3|= 0.1176
71009732|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-7.1|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-13.0|-1.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 5, pre-dose AM||-1.3|-13.0|
71009733|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-2.8|STANDARD_ERROR_OF_MEAN|2.4|||TWO_SIDED|95.0|-7.7|2.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 6, pre-dose AM||2.2|-7.7|
70926386|NCT04213872|141347697|OTHER|||||||0.04|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value CogOth 1.5 (2.1) 0.2 (0.4) \*-1.3 (1.7) .04~\*lower scores signifying better outcomes."||||.04
71009734|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-4.7|STANDARD_ERROR_OF_MEAN|2.4|||TWO_SIDED|95.0|-9.7|0.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 6, pre-dose AM||0.3|-9.7|
71009735|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-4.1|STANDARD_ERROR_OF_MEAN|3.6|||TWO_SIDED|95.0|-11.6|3.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, pre-dose AM||3.5|-11.6|
71009736|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-4.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-12.0|3.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, pre-dose AM||3.3|-12.0|
71046065|NCT03861481|141600292|SUPERIORITY||LS Mean difference (Rozimab - Placebo)|-0.052|||||TWO_SIDED|90.0|-0.892|0.788|||||MMRM analysis (fixed effect terms: treatment, baseline iRODS score, prior Ig therapy administration route, assessment week, treatment by week interaction; random effect term: study participant). LS Mean Difference \> 0 favours rozanolixizumab.|||0.788|-0.892|
71046066|NCT00773734|141600293|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|5.6||||0.1846|TWO_SIDED|95.0|-2.6|13.7|||Chi-squared|||||13.7|-2.6|0.1846
71046067|NCT00773734|141600293|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|23.1|||<|0.0001|TWO_SIDED|95.0|12.4|33.7|||Chi-squared|||||33.7|12.4|<0.0001
70926387|NCT04213872|141347698|OTHER|||||||0.01|||||||t-test, 2 sided|||Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value WAIS-III Letter/Number 10.7 (3.2) 12.7 (2.8) 2.0 (0.4) .01||||.01
71009737|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-4.3|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-10.6|1.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 1 hour||1.9|-10.6|
71009738|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-5.7|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-12.0|0.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 1 hour||0.7|-12.0|
71009739|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|1.0|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-8.3|10.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 4 hour||10.3|-8.3|
71046068|NCT00773734|141600293|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|35.2|||<|0.0001|TWO_SIDED|95.0|23.9|46.6|||Chi-squared|||||46.6|23.9|<0.0001
71046069|NCT00773734|141600295|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|13.2||||0.059|TWO_SIDED|95.0|-0.4|26.8|||Chi-squared|||||26.8|-0.4|0.0590
71046070|NCT00773734|141600295|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|22.1||||0.0023|TWO_SIDED|95.0|8.3|36.0|||Chi-squared|||||36.0|8.3|0.0023
71046071|NCT00773734|141600295|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|35.2|||<|0.0001|TWO_SIDED|95.0|21.6|48.9|||Chi-squared|||||48.9|21.6|<0.0001
71046072|NCT00773734|141600297|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|3.4||||0.1776|TWO_SIDED|95.0|-1.5|8.2|||Chi-squared|||||8.2|-1.5|0.1776
71009740|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|0.2|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-9.2|9.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 4 hour||9.7|-9.2|
71009741|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-4.6|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|-11.5|2.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose AM||2.3|-11.5|
71009742|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-2.9|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-9.9|4.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose AM||4.2|-9.9|
71009743|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-9.3|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-15.5|-3.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 1 hour||-3.0|-15.5|
71009744|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-8.3|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-14.6|-1.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 1 hour||-1.9|-14.6|
71009745|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-5.3|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-12.6|2.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 4 hour||2.0|-12.6|
71046073|NCT00773734|141600297|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|8.1||||0.0158|TWO_SIDED|95.0|1.6|14.5|||Chi-squared|||||14.5|1.6|0.0158
71046074|NCT00773734|141600297|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|10.2||||0.0051|TWO_SIDED|95.0|3.2|17.2|||Chi-squared|||||17.2|3.2|0.0051
71046075|NCT00773734|141600302|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.7||||0.0156|TWO_SIDED|95.0|-24.8|-2.6|||ANCOVA|Analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||-2.6|-24.8|0.0156
70926388|NCT04213872|141347699|OTHER|||||||0.6|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value~WAIS-III Digit Span Forward and Backward 19.2 (4.8) 19.7 (4.4) 0.5 (0.4) .60"||||.60
70926389|NCT04213872|141347700|OTHER|||||||0.03|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value PSQI 1.5 (0.8) 0.9 (0.7) \*-0.6 (0.1) .03~\*Lower scores mean better outcomes."||||.03
70926390|NCT04213872|141347701|OTHER|||||||0.05|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value POMS Anxiety 9.2 (7.7) 4.2 (3.7) \*-5.0 (4.0) .05~\*Lower scores mean better outcomes."||||.05
70926391|NCT04213872|141347702|OTHER|||||||0.08|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value POMS Depression 4.1 (4.9) 2.0 (3.0) \*-2.1 (1.9) .08~\*Lower scores mean better outcomes."||||.08
70926392|NCT04213872|141347703|OTHER|||||||0.3|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value BDNF 0.11 (0.9) 0.30 (0.7) 0.19 (0.2) .30~Higher scores mean better outcomes."||||.30
70926393|NCT04213872|141347704|OTHER|||||||0.8|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value NF-kB1 171.7 (25.4) 173.7 (21.6) 2.0 (3.8) .80~Higher scores mean better outcomes."||||.80
70926394|NCT04213872|141347705|OTHER|||||||0.61|||||||t-test, 2 sided|||Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value TP53 12.3 (2.7) 13.1 (5.5) 0.8 (2.8) .61||||.61
70926395|NCT03339713|141347706|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after the administration of influenza vaccine, using a non-inferiority margin of 2 for the GMT ratio (Group 2 / Group 1).|Geometric Mean Ratio|0.8|||<|0.001|TWO_SIDED|90.0|0.55|1.11|||t-test, 1 sided|||A/Michigan strain: Based on Welch-Satterthwaite t-interval method. The difference (Group 2 minus Group 1) and CI in log-transformed HI antibody titers were calculated for each of the 4 influenza vaccine strains, and were back-transformed (by exponentiation) to a GMT ratio (Group 2 / Group 1) and the corresponding CI.||1.11|0.55|<.001
70926396|NCT03339713|141347706|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after the administration of influenza vaccine, using a non-inferiority margin of 2 for the GMT ratio (Group 2 / Group 1).|Geometric Mean Ratio|0.8|||<|0.001|TWO_SIDED|90.0|0.59|1.12|||t-test, 1 sided|||A/Hong Kong strain: Based on Welch-Satterthwaite t-interval method. The difference (Group 2 minus Group 1) and CI in log-transformed HI antibody titers were calculated for each of the 4 influenza vaccine strains, and were back-transformed (by exponentiation) to a GMT ratio (Group 2 / Group 1) and the corresponding CI.||1.12|0.59|<.001
70926397|NCT03339713|141347706|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after the administration of influenza vaccine, using a non-inferiority margin of 2 for the GMT ratio (Group 2 / Group 1).|Geometric Mean Ratio|1.0|||<|0.001|TWO_SIDED|90.0|0.77|1.34|||t-test, 1 sided|||B/Brisbane strain: Based on Welch-Satterthwaite t-interval method. The difference (Group 2 minus Group 1) and CI in log-transformed HI antibody titers were calculated for each of the 4 influenza vaccine strains, and were back-transformed (by exponentiation) to a GMT ratio (Group 2 / Group 1) and the corresponding CI.||1.34|0.77|<.001
70926398|NCT03339713|141347706|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after the administration of influenza vaccine, using a non-inferiority margin of 2 for the GMT ratio (Group 2 / Group 1).|Geometric Mean Ratio|1.0|||<|0.001|TWO_SIDED|90.0|0.76|1.36|||t-test, 1 sided|||B/Phuket strain: Based on Welch-Satterthwaite t-interval method. The difference (Group 2 minus Group 1) and CI in log-transformed HI antibody titers were calculated for each of the 4 influenza vaccine strains, and were back-transformed (by exponentiation) to a GMT ratio (Group 2 / Group 1) and the corresponding CI.||1.36|0.76|<.001
70926399|NCT05505292|141347758|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
70926400|NCT05505292|141347759|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||||||0.66
71046076|NCT00773734|141600302|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.1|||<|0.0001|TWO_SIDED|95.0|-36.4|-13.9|||ANCOVA|Analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||-13.9|-36.4|<0.0001
71046077|NCT00773734|141600302|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-32.9|||<|0.0001|TWO_SIDED|95.0|-44.0|-21.7|||ANCOVA|Analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||-21.7|-44.0|<0.0001
71046078|NCT00773734|141600304|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-2.2||||0.6541|TWO_SIDED|95.0|-11.7|7.3|||Chi-squared|||||7.3|-11.7|0.6541
71046079|NCT00773734|141600304|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|12.4||||0.0402|TWO_SIDED|95.0|0.6|24.1|||Chi-squared|||||24.1|0.6|0.0402
71046080|NCT00773734|141600304|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|21.1||||0.0011|TWO_SIDED|95.0|8.8|33.4|||Chi-squared|||||33.4|8.8|0.0011
71046081|NCT00773734|141600308|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.2||||0.002|TWO_SIDED|95.0|-33.0|-7.5|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate||||-7.5|-33.0|0.0020
71046082|NCT00773734|141600308|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-29.9|||<|0.0001|TWO_SIDED|95.0|-42.9|-17.0|||ANCOVA|based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate||||-17.0|-42.9|<0.0001
71046083|NCT00773734|141600308|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-42.4|||<|0.0001|TWO_SIDED|95.0|-55.2|-29.5||Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate|ANCOVA|||||-29.5|-55.2|<0.0001
71046084|NCT00773734|141600310|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.3||||0.1322|TWO_SIDED|95.0|-3.1|0.4|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||0.4|-3.1|0.1322
70850352|NCT00947882|141188491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.0911||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 3. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 30 mg and Placebo at Month 3."|Analysis of Covariance (ANCOVA) of the change from baseline in IPSS at Month 3 in the FAS population using the Last Observation Carried Forward (LOCF) method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.0911
70926401|NCT05505292|141347760|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||||||0.23
71046085|NCT00773734|141600310|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-4.1|||<|0.0001|TWO_SIDED|95.0|-5.9|-2.3|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||-2.3|-5.9|<0.0001
70926402|NCT05505292|141347761|SUPERIORITY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||||||0.84
70926403|NCT05505292|141347762|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
70926404|NCT05505292|141347763|SUPERIORITY|||||||0.14|||||||Chi-squared|||||||0.14
70926405|NCT05505292|141347764|SUPERIORITY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||Question 1a Change from baseline to week 8 in lifitegrast vs vehicle||||0.62
70926406|NCT05505292|141347764|SUPERIORITY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||Question 1b change from baseline to week 8 in lifitegrast vs vehicle groups||||0.53
70926407|NCT05505292|141347764|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Question 2a change from baseline to week 8 in lifitegrast vs vehicle groups||||0.66
70926408|NCT05505292|141347764|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Question 2b change from baseline to week 8 in lifitegrast vs vehicle groups||||0.81
70926409|NCT05505292|141347764|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||Question 3a change from baseline to week 8 in lifitegrast vs vehicle groups||||>0.999
70926410|NCT05505292|141347764|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Question 3b change from baseline to week 8 in lifitegrast vs vehicle groups||||0.47
70926411|NCT05505292|141347764|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Question 4 change from baseline to week 8 in lifitegrast vs vehicle groups||||0.52
70926412|NCT05505292|141347764|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||Question 5 change from baseline to week 8 in lifitegrast vs vehicle groups||||0.69
70926413|NCT01073566|141347779|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Pre-study power calculations determined that 28 completed subjects provided 90% power to detect equivalence for the primary endpoint of MDBG of bolus-patch compared to pen/syringe using a 2-sided alpha level of 0.05, when the margin of equivalence for MDBG is 1.11 mmol/L, the true mean difference is 0.0, and the standard deviation of the differences is 1.72 mmol/L.|Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.24||0.098|TWO_SIDED|95.0|-0.97|0.16|||ANOVA||Finesse versus usual injection device.|A two-period, two-treatment crossover ANOVA model was used to compare devices for continuous measures.||0.16|-0.97|0.098
70926414|NCT01073566|141347780|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.15||0.004|TWO_SIDED|95.0|-0.8|-0.17|||ANOVA||Finesse versus usual injection device|This was conducted at a 2-sided alpha level of 0.05 and confidence intervals (CI) were calculated at 95%, 2-sided. A two-period, two-treatment crossover ANOVA model was used to compare devices for continuous measures.||-0.17|-0.80|0.004
70926415|NCT01073566|141347781|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||McNemar|||Higher number is better. The answers were scored on a scale of 0-100 to standardize as described in the original papers.||||<0.001
70926416|NCT01389856|141347788|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Fisher Exact|||||||1
70926417|NCT01389856|141347789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3407|TWO_SIDED||||||Log Rank|||||||0.3407
71046086|NCT00773734|141600310|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.6||||0.0047|TWO_SIDED|95.0|-4.3|-0.8|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||-0.8|-4.3|0.0047
70926418|NCT01389856|141347790|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2399|TWO_SIDED||||||Log Rank|||||||0.2399
70926419|NCT01389856|141347792|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.000
70926420|NCT01389856|141347793|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2235|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.2235
70926421|NCT01389856|141347794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1468|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.1468
71046087|NCT00773734|141600312|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|3.3||||0.0078|TWO_SIDED|95.0|0.9|5.8|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||5.8|0.9|0.0078
70926422|NCT01389856|141347795|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0789|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.0789
70926423|NCT01389856|141347796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3723|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.3723
70926424|NCT01389856|141347797|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0569|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.0569
70926425|NCT01389856|141347798|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1015|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.1015
70926426|NCT01389856|141347799|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0824|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.0824
70926427|NCT01389856|141347800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3863|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.3863
70926428|NCT01389856|141347801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3936|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.3936
70926429|NCT01389856|141347802|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2436|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.2436
70926430|NCT01389856|141347803|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1756|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.1756
70926431|NCT01389856|141347804|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1155|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.1155
70926432|NCT01389856|141347805|SUPERIORITY_OR_OTHER_LEGACY|||||||0.14|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.1400
70926433|NCT05604508|141347824|OTHER||Odds Ratio (OR)|0.735|||||TWO_SIDED|95.0|0.347|1.553|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, and baseline cigarette use intentions|||1.553|0.347|
70926434|NCT05604508|141347824|OTHER||Odds Ratio (OR)|0.471|||||TWO_SIDED|95.0|0.234|0.947|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, and baseline cigarette use intentions.|||0.947|0.234|
71009746|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|3.6|||TWO_SIDED|95.0|-8.7|6.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 4 hour||6.1|-8.7|
71009747|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|3.6|||TWO_SIDED|95.0|-8.2|6.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose PM||6.7|-8.2|
71009748|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-7.3|7.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose PM||7.9|-7.3|
71009749|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-4.9|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|95.0|-10.3|0.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 9, pre-dose AM||0.6|-10.3|
71009750|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-2.2|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-7.7|3.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 9, pre-dose AM||3.4|-7.7|
70926435|NCT05604508|141347825|OTHER||Odds Ratio (OR)|1.503|||||TWO_SIDED|95.0|0.727|3.107|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, baseline vaping intentions|||3.107|0.727|
70926436|NCT05604508|141347825|OTHER||Odds Ratio (OR)|0.878|||||TWO_SIDED|95.0|0.398|1.938|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, baseline vaping intentions|||1.938|0.398|
71009751|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-3.9|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-10.0|2.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 10, pre-dose||2.3|-10.0|
71009752|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-5.1|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-11.4|1.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 10, pre-dose AM||1.2|-11.4|
71117592|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|6.33||||0.187|TWO_SIDED|95.0|-2.99|15.65||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.65|-2.99|0.187
70926437|NCT05604508|141347826|OTHER||Odds Ratio (OR)|0.619|||||TWO_SIDED|95.0|0.295|1.301|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, and baseline smokeless use intentions|||1.301|0.295|
71009753|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-8.7|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-15.2|-2.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 11, pre-dose AM||-2.2|-15.2|
71009754|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-5.3|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-12.0|1.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 11, pre-dose AM||1.3|-12.0|
71009755|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-2.4|STANDARD_ERROR_OF_MEAN|2.5|||TWO_SIDED|95.0|-7.6|2.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 12, pre-dose AM||2.8|-7.6|
70926438|NCT05604508|141347826|OTHER||Odds Ratio (OR)|0.489|||||TWO_SIDED|95.0|0.237|1.006|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco, baseline smokeless use intentions|||1.006|0.237|
70926439|NCT05604508|141347827|OTHER||Odds Ratio (OR)|1.428|||||TWO_SIDED|95.0|0.72|2.832|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, baseline LCC use intentions|||2.832|0.720|
71009756|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-4.5|STANDARD_ERROR_OF_MEAN|2.5|||TWO_SIDED|95.0|-9.7|0.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 12, pre-dose AM||0.8|-9.7|
71009757|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-4.9|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-10.7|0.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose AM||0.8|-10.7|
71009758|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-4.6|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-10.4|1.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose AM||1.3|-10.4|
71009759|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-9.0|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-14.6|-3.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 1 hour||-3.4|-14.6|
71009760|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-8.5|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-14.2|-2.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 1 hour||-2.8|-14.2|
71009761|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-6.2|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-13.8|1.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 4 hour||1.5|-13.8|
71009762|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-6.5|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-14.3|1.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 4 hour||1.2|-14.3|
71009763|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-8.0|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-15.0|-1.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose PM||-1.0|-15.0|
71009764|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-7.1|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-14.2|0.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose PM||0|-14.2|
71009765|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-1.7|STANDARD_ERROR_OF_MEAN|3.9|||TWO_SIDED|95.0|-9.8|6.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, pre-dose AM||6.4|-9.8|
71009766|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-8.0|8.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, pre-dose AM||8.5|-8.0|
71046088|NCT00773734|141600312|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|3.5||||0.0068|TWO_SIDED|95.0|1.0|6.0|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||6.0|1.0|0.0068
71046089|NCT00773734|141600312|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|3.6||||0.0045|TWO_SIDED|95.0|1.1|6.1|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||6.1|1.1|0.0045
71046090|NCT00773734|141600313|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.6||||0.6097|TWO_SIDED|95.0|-1.6|2.8|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||2.8|-1.6|0.6097
71046091|NCT00773734|141600313|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|1.3||||0.2424|TWO_SIDED|95.0|-0.9|3.6|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||3.6|-0.9|0.2424
71103355|NCT00600340|141714746|SUPERIORITY|HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|1.31||||0.0094|TWO_SIDED|95.0|1.07|1.61|||Log Rank|Two-sided log-rank test adjusted by stratification factors at randomization|HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab plus Capecitabine vs. Bevacizumab plus Paclitaxel for PFS (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||1.61|1.07|0.0094
71009767|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-2.6|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-9.0|3.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 15, Discharge||3.7|-9.0|
71009768|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-7.1|5.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 15, Discharge||5.8|-7.1|
71009769|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|-0.8|STANDARD_ERROR_OF_MEAN|2.3|||TWO_SIDED|95.0|-5.5|3.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 21, Follow-up||3.9|-5.5|
71009770|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|0.2|STANDARD_ERROR_OF_MEAN|2.3|||TWO_SIDED|95.0|-4.6|4.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 21, Follow-up||4.9|-4.6|
71009771|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|2.1|STANDARD_ERROR_OF_MEAN|4.2|||TWO_SIDED|95.0|-6.5|10.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 42, End of trial||10.7|-6.5|
71009772|NCT03091920|141526959|OTHER|No statistical testing was performed.|Least squares mean difference|0.8|STANDARD_ERROR_OF_MEAN|4.2|||TWO_SIDED|95.0|-7.9|9.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 42, End of trial||9.6|-7.9|
71009773|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|6.2|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-4.4|16.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 1 hour||16.8|-4.4|
71009774|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|9.1|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-1.5|19.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 1 hour||19.8|-1.5|
71046092|NCT00773734|141600313|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.1||||0.9528|TWO_SIDED|95.0|-2.2|2.3|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||2.3|-2.2|0.9528
71046093|NCT01287039|141600418|SUPERIORITY_OR_OTHER_LEGACY||CAE rate ratio (reslizumab vs placebo)|0.501|||<|0.0001|TWO_SIDED|95.0|0.3726|0.6737||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.||0.6737|0.3726|<0.0001
70926440|NCT05604508|141347827|OTHER||Odds Ratio (OR)|1.42|||||TWO_SIDED|95.0|0.681|2.96|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, baseline LCC use intentions|||2.960|0.681|
70926441|NCT01743807|141347866|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
70926442|NCT01814813|141347925|SUPERIORITY|||||||0.16|||||||Log Rank|||||||0.16
70926443|NCT01814813|141347926|SUPERIORITY||||||<|0.01|||||||Log Rank|||||||<0.01
71009775|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-9.0|9.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 4 hour||9.0|-9.0|
71009776|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|4.4|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-4.6|13.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 4 hour||13.4|-4.6|
71009777|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-7.5|7.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 8 hour||7.1|-7.5|
71009778|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|1.6|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-5.7|8.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 8 hour||8.9|-5.7|
71009779|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|5.1|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-2.0|12.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, pre-dose PM||12.1|-2.0|
71009780|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|5.2|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-1.8|12.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, pre-dose PM||12.3|-1.8|
71009781|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|2.3|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-5.1|9.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose PM 1 hour||9.6|-5.1|
71009782|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|1.3|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-6.0|8.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose PM 1 hour||8.7|-6.0|
71046094|NCT01287039|141600419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.137|STANDARD_ERROR_OF_MEAN|0.0311|<|0.0001|TWO_SIDED|95.0|0.076|0.198|||Mixed Model Repeated Measures|||For each week and overall change, inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment and sex as fixed factors, and covariates for height and baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures.||0.198|0.076|<0.0001
71046095|NCT01287039|141600420|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.238|STANDARD_ERROR_OF_MEAN|0.0967||0.0143|TWO_SIDED|95.0|0.048|0.428|||Mixed model repeated measures|||For each week and overall change, inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment and sex as fixed factors, and covariates for height and baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures.||0.428|0.048|0.0143
71046096|NCT01287039|141600421|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.266|STANDARD_ERROR_OF_MEAN|0.0681||0.0001|TWO_SIDED|95.0|-0.399|-0.132|||Mixed model repeated measures|||For each week and overall change, inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment and sex as fixed factors, and covariates for height and baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures.||-0.132|-0.399|0.0001
71046097|NCT01287039|141600422|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.575|||<|0.0001|TWO_SIDED|95.0|0.44|0.75|||Regression, Cox|Stratified by baseline usage of oral corticosteroid (yes or no) and geographical region (US or other).|Reslizumab vs placebo|Kaplan-Meier estimate of probability (5) of not experiencing a CAE by week 52. The first CAEs for each patient occurring after randomization and up to 2 weeks after the end of treatment period were analyzed. Patients without a CAE within this time frame were censored at two weeks after the treatment completion date or study discontinuation, whichever came first.||0.750|0.440|<0.0001
71009783|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|1.0|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-5.0|6.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose AM||6.9|-5.0|
71009784|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|0.7|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-5.3|6.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose AM||6.6|-5.3|
71009785|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|2.5|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-8.1|13.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 1 hour||13.2|-8.1|
70926444|NCT01814813|141347927|SUPERIORITY|||||||0.56|||||||Chi-squared|||||||0.56
70926445|NCT03344094|141347928|OTHER|changes in subsets paired and unpaired t-tests, ANOVA||||||0.05|||||||ANOVA|||||||0.05
71009786|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|4.3|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-6.3|15.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 1 hour||15.0|-6.3|
71009787|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|3.3|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-4.6|11.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 4 hour||11.2|-4.6|
71009788|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|7.0|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-1.0|14.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 4 hour||14.9|-1.0|
71009789|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-8.5|5.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose PM||5.9|-8.5|
71046098|NCT01287039|141600423|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.0125|<|0.0001|TWO_SIDED|95.0|0.034|0.083|||Mixed model repeated measures|||For each week, inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment as fixed factor, and covariate baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures.||0.083|0.034|<0.0001
71009790|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-8.5|5.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose PM||5.9|-8.5|
71009791|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|0.1|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-9.2|9.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 1 hour||9.5|-9.2|
71009792|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-9.5|9.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 1 hour||9.2|-9.5|
71009793|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|1.2|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-5.1|7.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 4 hour||7.4|-5.1|
71009794|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|2.9|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-3.4|9.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 4 hour||9.2|-3.4|
71009795|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|-1.4|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-7.5|4.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, pre-dose AM||4.8|-7.5|
71009796|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-6.5|5.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, pre-dose AM||5.8|-6.5|
71009797|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|-2.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-9.9|5.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, post-dose PM 4 hour||5.3|-9.9|
71009798|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|2.2|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-5.4|9.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, post-dose PM 4 hour||9.8|-5.4|
71009799|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|7.0|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|0.2|13.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 4, pre-dose AM||13.7|0.2|
71009800|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|5.0|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|-1.7|11.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 4, pre-dose AM||11.8|-1.7|
71009801|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|2.9|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-3.1|9.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 5, pre-dose AM||9.0|-3.1|
71009802|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|2.6|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-3.4|8.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 5, pre-dose AM||8.7|-3.4|
71046099|NCT01287039|141600424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.276|STANDARD_ERROR_OF_MEAN|0.1632||0.0919|TWO_SIDED|95.0|-0.597|0.045|||Mixed model repeated measures|||Inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, OCS use at enrollment as fixed factors, and covariate for baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures.||0.045|-0.597|0.0919
71046100|NCT01287039|141600425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.466|STANDARD_ERROR_OF_MEAN|0.0244|<|0.0001|TWO_SIDED|95.0|-0.514|-0.418|||Mixed model repeated measures|||"Eosinophil Count Over 16 Weeks~Inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment as fixed factor, and covariate baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures."||-0.418|-0.514|<0.0001
71046101|NCT01287039|141600425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.455|STANDARD_ERROR_OF_MEAN|0.0182|<|0.0001|TWO_SIDED|95.0|-0.491|-0.419|||Mixed model repeated measures|||"Eosinophil Count Over 52 Weeks~Inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment as fixed factor, and covariate baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures."||-0.419|-0.491|<0.0001
71046102|NCT01287039|141600427|SUPERIORITY_OR_OTHER_LEGACY||CAE rate ratio (reslizumab vs placebo)|0.4499|||<|0.0001|TWO_SIDED|95.0|0.3255|0.622||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||CAE Due to Requiring Systemic Corticosteroids The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.||0.6220|0.3255|<0.0001
71046103|NCT01287039|141600427|SUPERIORITY_OR_OTHER_LEGACY||CAE rate ratio (reslizumab vs placebo)|0.6595||||0.2572|TWO_SIDED|95.0|0.321|1.355||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||CAE Due to Hospitalization or ER visit The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.||1.3550|0.3210|0.2572
71046104|NCT03438396|141600485|OTHER|The statistical hypotheses was tested to address ORR \<= 11% vs. ORR \> 11%.||||||0.0002|||||||one-sided exact test|||||||0.0002
71046105|NCT02006628|141600498|SUPERIORITY||Treatment difference (GWP42003-placebo)|-2.8||||0.1332|TWO_SIDED|95.0|-6.5|0.9|||ANCOVA|Change from baseline as the response variable, treatment as fixed effect, and individual baseline subscore and age as covariates.||||0.9|-6.5|0.1332
71046106|NCT02006628|141600499|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0896|TWO_SIDED|95.0|0.86|8.0|||Regression, Logistic|Responder (yes/no) is the dependent variable with treatment included as factor and age and baseline P, G, and N scores included as covariates.||||8.00|0.86|0.0896
71046107|NCT02006628|141600500|SUPERIORITY||Treatment difference (GWP42003-placebo)|-1.4||||0.0188|TWO_SIDED|95.0|-2.5|-0.2|||ANCOVA|||||-0.2|-2.5|0.0188
71103356|NCT00600340|141714747|SUPERIORITY|HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|1.13||||0.1957|TWO_SIDED|95.0|0.94|1.35||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab plus Capecitabine vs. Bevacizumab plus Paclitaxel for TTF (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||1.35|0.94|0.1957
70941329|NCT00985621|141383145|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.48|-0.43|||ANCOVA|||Change at Week 4: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.43|-1.48|<0.001
71046108|NCT02006628|141600501|SUPERIORITY||Treatment difference (GWP42003-placebo)|0.0||||0.9647|TWO_SIDED|95.0|-1.3|1.4|||ANCOVA|||||1.4|-1.3|0.9647
71046109|NCT02006628|141600502|SUPERIORITY||Treatment difference (GWP42003-placebo)|-1.3||||0.1963|TWO_SIDED|95.0|-3.2|0.7|||ANCOVA|||||0.7|-3.2|0.1963
71046110|NCT02006628|141600503|SUPERIORITY||Treatment difference (GWP42003-placebo)|-3.5||||0.1167|TWO_SIDED|95.0|-7.9|0.9|||ANCOVA|||||0.9|-7.9|0.1167
71046111|NCT02006628|141600504|SUPERIORITY||Treatment difference (GWP42003-placebo)|-0.3||||0.0443|TWO_SIDED|95.0|-0.5|0.0|||ANCOVA|||||0.0|-0.5|0.0443
71046112|NCT02006628|141600505|SUPERIORITY||Treatment difference (GWP42003-placebo)|-0.5||||0.0182|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|||||-0.1|-0.8|0.0182
71046113|NCT02006628|141600506|SUPERIORITY||Treatment difference (GWP42003-placebo)|1.31||||0.0677|TWO_SIDED|95.0|-0.1|2.72|||ANCOVA|||||2.72|-0.10|0.0677
71046114|NCT01421342|141600507|SUPERIORITY||Odds Ratio (OR)|1.31||||0.076|TWO_SIDED|95.0|0.97|1.75||Co-primary hypothesis: After ordering results from largest p-value to smallest (Hochberg approach) the comparison of Augmenting Antidepressant+Bupropion with Switching to Bupropion-SR was performed at the 0.05 significance level.|Regression, Logistic|Stratified by participating medical center|Represents relative odds of remission for Augmentation Antidepressant + Bupropion-SR / Switching to Bupropion-SR|||1.75|0.97|0.076
71046115|NCT01421342|141600507|SUPERIORITY||Odds Ratio (OR)|1.42||||0.018|TWO_SIDED|95.0|1.06|1.89||Co-primary hypothesis: Second ordered test after ordering largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Aripiprazole with Switching to Bupropion-SR was performed at the 0.025 significance level.|Regression, Logistic|Stratified by participating medical center|Represents relative odds of remission for Augmentation Antidepressant + Aripiprazole / Switching to Bupropion-SR|Co-primary hypothesis: After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Aripiprazole with Switching to Bupropion-SR was performed at the 0.025 significance level.||1.89|1.06|0.018
70926446|NCT03808818|141347931|EQUIVALENCE|the smallest detectable difference will be 22%|Odds Ratio (OR)|2.3||||0.0046|TWO_SIDED|95.0|1.28|4.13||No correction for multiple comparisons|Chi-squared|||"For self-reported 7-day point prevalence abstinence at 6-months, with a sample size of 140 in each arm then smallest detectable difference will be 22% with 80% power. Subsequent analyses will use a Bonferroni corrected alpha of 0.002 using with an estimated control rate of 31%.~The primary analysis will be performed from an intent-to-treat perspective. Chi-square tests will be used to compare the outcomes between treatment groups."||4.13|1.28|0.0046
70926447|NCT03808818|141347932|EQUIVALENCE|the smallest detectable difference will be 22% with 80% power and a Bonferroni corrected alpha of 0.002 using and an estimated control rate of 28%.|Odds Ratio (OR)|1.86||||0.035|TWO_SIDED|95.0|1.04|3.33|||Chi-squared|||7-day point prevalence abstinence at 3-months, with a sample size of 140 in each arm then smallest detectable difference will be 18% with 80% power and a Bonferroni corrected alpha of 0.002 using and an estimated control rate of 20%||3.33|1.04|0.035
70926448|NCT03808818|141347933|EQUIVALENCE|the smallest detectable difference will be 21% with 80% power and a Bonferroni corrected alpha of 0.002 and an estimated control rate of 20%.||||||0.016|||||||Chi-squared|||power calculations assumed a sample size of 140 in each arm and a Bonferroni corrected alpha of 0.002 and an estimated control rate of 20%||||0.016
70926449|NCT03808818|141347935|EQUIVALENCE|no margin||||||0.069|||||||Chi-squared|||||||0.069
70926450|NCT03808818|141347936|EQUIVALENCE|no margin||||||0.86|||||||Chi-squared|||||||0.86
70926451|NCT03808818|141347948|EQUIVALENCE|No equivalence margin|||||<|0.0001||||||Alpha level 0.01|Fisher Exact|||Fisher's exact tests were performed to assess the differences between the VST and EUC arms on the 6-month questionnaire.||||<.0001
71046116|NCT01421342|141600507|SUPERIORITY||Odds Ratio (OR)|1.11||||0.46|TWO_SIDED|95.0|0.84|1.48||Following the gate-keeping strategy of the analysis plan, complete the comparison of Augmentation Antidepressant + Aripiprazole vs. Augmentation Antidepressant + Bupropion-SR was evaluated at the 0.05 significance level.|Regression, Logistic||Represents relative odds of remission for Augmentation Antidepressant + Aripiprazole / Augmentation Antidepressant + Bupropion-SR|If either if the first two hypothesis tests for the co-primary hypotheses were significant, perform the test of Augmentation Antidepressant + Aripiprazole vs. Augmentation Antidepressant + Bupropion-SR at the 0.05 significance level.||1.48|0.84|0.46
71046117|NCT01421342|141600508|SUPERIORITY||Hazard Ratio (HR)|1.36||||0.7|TWO_SIDED|95.0|0.78|2.39|||Log Rank||Represents relative odds of relapse for Augmentation Antidepressant + Bupropion-SR / Switching to Bupropion-SR|||2.39|0.78|0.70
71046118|NCT01421342|141600508|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.68|TWO_SIDED|95.0|0.65|1.94|||Log Rank||Represents relative odds of relapse for Augmentation Antidepressant + Aripiprazole / Switching to Bupropion-SR|||1.94|0.65|0.68
71046119|NCT01421342|141600508|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.87|TWO_SIDED|95.0|0.58|1.59|||Log Rank||Represents relative odds of relapse for Augmentation Antidepressant + Aripiprazole / Augmentation Antidepressant + Bupropion-SR|||1.59|0.58|0.87
71046120|NCT01421342|141600509|SUPERIORITY||Odds Ratio (OR)|1.16||||0.28|TWO_SIDED|95.0|0.89|1.5|||Regression, Logistic|Stratified by participating medical center|Represents relative odds of response for Augmentation Antidepressant + Bupropion / Switching to Bupropion|After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Bupropion with Switching to Bupropion was performed at the 0.05 significance level.||1.50|0.89|0.28
71046121|NCT01421342|141600509|SUPERIORITY||Odds Ratio (OR)|1.74|||<|0.0001|TWO_SIDED|95.0|1.33|2.29|||Regression, Logistic|Stratified by participating medical center (site)|Represents relative odds of response for Augmentation Antidepressant + Aripiprazole / Switching to Bupropion-SR|After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Aripiprazole with Switching to Bupropion-SR was performed at the 0.025 significance level.||2.29|1.33|<0.0001
71046122|NCT01421342|141600509|SUPERIORITY||Odds Ratio (OR)|1.55||||0.002|TWO_SIDED|95.0|1.17|2.05||Following the gate-keeping strategy of the analysis plan, complete the comparison of Augmentation Antidepressant + Aripiprazole with Augmentation Antidepressant + Bupropion-SR at the 0.05 significance level.|Regression, Logistic|Stratified by participating medical center|Represents relative odds of response for Augmentation Antidepressant + Aripiprazole / Augmentation Antidepressant + Bupropion-SR|||2.05|1.17|0.002
71046123|NCT01421342|141600510|SUPERIORITY||Odds Ratio (OR)|1.26||||0.11|TWO_SIDED|95.0|0.95|1.68||After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Bupropion with Switching to Bupropion was performed at the 0.05 significance level.|Regression, Logistic|Stratified by participating medical center|Represents relative odds of response for Augmentation Antidepressant + Bupropion / Switching to Bupropion|||1.68|0.95|0.11
71046124|NCT01421342|141600510|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.26|2.29|||Regression, Logistic|Stratified by participating medical center|Represents relative odds of response for Augmentation Antidepressant + Aripiprazole / Switching to Bupropion-SR|After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Aripiprazole with Switching to Bupropion-SR was performed at the 0.025 significance level.||2.29|1.26|<0.001
70926452|NCT03808818|141347949|EQUIVALENCE|No equivalence margin|||||<|0.0001||||||Alpha level 0.01|Fisher Exact|||Fisher's exact tests were performed to assess the differences between the VST and EUC arms on the 6-month questionnaire.||||<.0001
70926453|NCT03808818|141347950|EQUIVALENCE|No equivalence margin|||||<|0.0001||||||Alpha level 0.01|Fisher Exact|||Fisher's exact tests were performed to assess the differences between the VST and EUC arms on the 6-month questionnaire.||||<.0001
70926454|NCT03808818|141347952|EQUIVALENCE|No equivalence margin|||||<|0.0001||||||Alpha level 0.01|Fisher Exact|||Fisher's exact tests were performed to assess the differences between the VST and EUC arms on the 6-month questionnaire.||||<.0001
70926455|NCT05415722|141347958|SUPERIORITY||Mean Difference (Final Values)|-11.39|STANDARD_ERROR_OF_MEAN|7.48||0.1303|TWO_SIDED|95.0|-26.178|3.406|||ANCOVA|||Arm 1 compared to Placebo||3.406|-26.178|0.1303
70926456|NCT05415722|141347958|SUPERIORITY||Mean Difference (Final Values)|-23.47|STANDARD_ERROR_OF_MEAN|7.924||0.0036|TWO_SIDED|95.0|-39.14|-7.799|||ANCOVA|||Arm 2 compared to Placebo||-7.799|-39.140|0.0036
70926457|NCT05415722|141347958|SUPERIORITY||Mean Difference (Final Values)|-40.8|STANDARD_ERROR_OF_MEAN|7.96|<|0.0001|TWO_SIDED|95.0|-56.545|-25.064|||ANCOVA|||Arm 3 compared to Placebo||-25.064|-56.545|<0.0001
70926458|NCT05415722|141347959|SUPERIORITY||Mean Difference (Final Values)|-31.9|STANDARD_ERROR_OF_MEAN|20.87||0.1289|TWO_SIDED|95.0|-73.17|9.39|||ANCOVA|||Arm 1 compared to Placebo||9.39|-73.17|0.1289
70926459|NCT05415722|141347959|SUPERIORITY||Mean Difference (Final Values)|-29.3|STANDARD_ERROR_OF_MEAN|21.65||0.179|TWO_SIDED|95.0|-72.08|13.58|||ANCOVA|||Arm 2 compared to Placebo||13.58|-72.08|0.1790
70926460|NCT05415722|141347959|SUPERIORITY||Mean Difference (Final Values)|-75.7|STANDARD_ERROR_OF_MEAN|21.96||0.0008|TWO_SIDED|95.0|-119.08|-32.23|||ANCOVA|||Arm 3 compared to Placebo||-32.23|-119.08|0.0008
70926461|NCT05415722|141347960|SUPERIORITY||Mean Difference (Final Values)|-16.74|STANDARD_ERROR_OF_MEAN|7.895||0.0358|TWO_SIDED|95.0|-32.352|-1.128|||ANCOVA|||Arm 4 compared to Placebo||-1.128|-32.352|0.0358
71009803|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|2.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-5.4|10.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 6, pre-dose AM||10.0|-5.4|
71009804|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-8.4|7.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 6, pre-dose AM||7.0|-8.4|
71009805|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|5.1|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-1.6|11.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, pre-dose AM||11.8|-1.6|
71009806|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|5.0|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-1.7|11.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, pre-dose AM||11.7|-1.7|
71009807|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|9.3|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|95.0|-1.6|20.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 1 hour||20.2|-1.6|
71009808|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|13.0|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|2.1|23.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 1 hour||23.9|2.1|
71009809|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|7.1|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|0.2|13.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 4 hour||13.9|0.2|
71009810|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|11.5|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|4.6|18.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 4 hour||18.3|4.6|
71009811|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|1.9|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-4.8|8.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose AM||8.6|-4.8|
71046125|NCT01421342|141600510|SUPERIORITY||Odds Ratio (OR)|1.37||||0.043|TWO_SIDED|95.0|1.01|1.86||Following the gate-keeping strategy of the analysis plan, complete the comparison of Augmentation Antidepressant + Aripiprazole with Augmentation Antidepressant + Bupropion-SR at the 0.05 significance level.|Regression, Logistic||Represents relative odds of response for Augmentation Antidepressant + Aripiprazole / Augmentation Antidepressant + Bupropion-SR|||1.86|1.01|0.043
71046126|NCT02493777|141600540|SUPERIORITY||||||<|0.001|||||||Mixed model repeated measures analysis|||||||<0.001
71046127|NCT02493777|141600541|SUPERIORITY||||||<|0.001|||||||Mixed model repeated measures analysis|||||||<0.001
71046128|NCT01642914|141600545|SUPERIORITY_OR_OTHER|||||||0.0054|ONE_SIDED||||||Kolmogorov-Smirnov|Kolmogorov-Smirnov test for equality of distribution||||||0.0054
71046129|NCT01642914|141600545|SUPERIORITY_OR_OTHER|||||||0.0012|ONE_SIDED||||||Kolmogorov-Smirnov|Kolmogorov-Smirnov test for equality of distribution||||||0.0012
71046130|NCT01642914|141600558|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.193||||0.0006|TWO_SIDED|95.0|0.086|0.3||p-Values were obtained from the Cochran-Mantel-Haenszel tests controlling for geographic region, comparing each linaclotide dose versus placebo in a pairwise manner.|Cochran-Mantel-Haenszel|||||.300|.086|0.0006
71009812|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|4.1|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-2.6|10.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose||10.8|-2.6|
71009813|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|9.7|STANDARD_ERROR_OF_MEAN|4.7|||TWO_SIDED|95.0|-0.1|19.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 1 hour||19.6|-0.1|
71009814|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|9.6|STANDARD_ERROR_OF_MEAN|4.7|||TWO_SIDED|95.0|-0.3|19.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 1 hour||19.4|-0.3|
71009815|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|7.8|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|0.0|15.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 4 hour||15.5|0|
71009816|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|8.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|0.6|16.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 4 hour||16.1|0.6|
71046131|NCT01642914|141600558|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.17||||0.0022|TWO_SIDED|95.0|0.064|0.227||p-Values were obtained from the Cochran-Mantel-Haenszel tests controlling for geographic region, comparing each linaclotide dose versus placebo in a pairwise manner.|Cochran-Mantel-Haenszel|||||.227|.064|0.0022
71046132|NCT01642914|141600559|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.37||||0.0054|TWO_SIDED|95.0|1.09|1.72|||Log Rank|Log-rank test stratified by geographic region.||||1.72|1.09|.0054
71046133|NCT01642914|141600559|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.24||||0.047|TWO_SIDED|95.0|0.99|1.55|||Log Rank|Log-rank test stratified by geographic region.||||1.55|0.99|0.0470
71009817|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|3.3|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-5.1|11.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose PM||11.7|-5.1|
70926462|NCT05415722|141347960|SUPERIORITY||Mean Difference (Final Values)|-43.73|STANDARD_ERROR_OF_MEAN|7.647|<|0.0001|TWO_SIDED|95.0|-58.858|-28.612|||ANCOVA|||Arm 5 compared to Placebo||-28.612|-58.858|<0.0001
70926463|NCT05415722|141347961|SUPERIORITY||Mean Difference (Final Values)|-62.6|STANDARD_ERROR_OF_MEAN|22.09||0.0053|TWO_SIDED|95.0|-106.33|-18.96|||ANCOVA|||Arm 4 compared to Placebo||-18.96|-106.33|0.0053
70926464|NCT05415722|141347961|SUPERIORITY||Mean Difference (Final Values)|-69.2|STANDARD_ERROR_OF_MEAN|21.13||0.0014|TWO_SIDED|95.0|-110.97|-27.39|||ANCOVA|||Arm 5 compared to Placebo||-27.39|-110.97|0.0014
70926465|NCT03031470|141347995|SUPERIORITY|||||||0.688|||||||Fisher Exact|Analysis is based on exact Fisher test to compare treatments.||||||0.688
70926466|NCT03031470|141347996|SUPERIORITY|||||||0.7|||||||Fisher Exact|Analysis is based on exact Fisher test to compare treatments.||||||0.700
70926467|NCT03031470|141347997|SUPERIORITY||||||>|0.999|||||||Fisher Exact|Treatment groups were compared for frequency of allograft nonfunction using Fisher exact test||||||>0.999
70926468|NCT03031470|141347998|SUPERIORITY|||||||0.308|||||||Fisher Exact|||||||0.308
70926469|NCT03031470|141347999|SUPERIORITY|||||||0.601|||||||Fisher Exact|||||||0.601
70926470|NCT03031470|141348001|SUPERIORITY|||||||0.574|||||||Cochran-Mantel-Haenszel|Reparixin and Control groups will be compared for degree of allograft steatosis using Cochran-Mantel-Hensel (CMH) test with control EAD.||||||0.574
70926471|NCT03031470|141348002|SUPERIORITY|||||||0.843|||||||Cochran-Mantel-Haenszel|Reparixin and Control groups will be compared for duration of cold ischemia using Cochran-Mantel-Hensel (CMH) test with control EAD.||||||0.843
70926472|NCT03031470|141348003|SUPERIORITY|||||||0.701|||||||Cochran-Mantel-Haenszel|Reparixin and Control groups will be compared for duration of earm ischemia using Cochran-Mantel-Hensel (CMH) test with control EAD.||||||0.701
70926473|NCT03031470|141348013|SUPERIORITY|"General survival and graft survival (graft loss will be qualified as an event for graft survival) within 1 year were presented with Kaplan-Mayer curves and survival time median with 95% CI. Treatment groups will be compared using logrank test."||||||0.416|||||||Log Rank|||||||0.416
70926474|NCT03461276|141348017|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|A 1-sided t-test with a significance level of 0.025 was employed.||"The trial was considered successfully confirmatory regarding efficacy (immunogenicity) of ABvac40 if the average MΔ of anti-Aβ40 antibody signal (OD in ELISA) in the ABvac40 group was significantly greater than the average MΔ of anti-Aβ40 antibody signal in the Placebo group. i.e.~* Null hypothesis: average MΔ anti-Aβ40 (ABvac40) ≤ average MΔ anti-Aβ40 (placebo).~* Alternative hypothesis: average MΔ anti-Aβ40 (ABvac40) \> average MΔ anti-Aβ40 (placebo)."||||<0.0001
70926475|NCT03461276|141348017|SUPERIORITY|Additional test|||||<|0.0001||||||1-sided|Wilcoxon (Mann-Whitney)|||||||<0.0001
70926476|NCT03461276|141348017|SUPERIORITY||Mean Difference (Final Values)|3.15|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|2.96|3.34|||ANCOVA|||The average MΔ of anti-Aβ40 antibody signal between the two treatment groups was compared using an ANCOVA model, using the MΔ anti-Aβ40 antibody signal as the dependent variable, baseline anti-Aβ40 antibody signal (OD in ELISA) as covariate and treatment group and amyloid positivity as fixed effects.||3.34|2.96|<0.0001
70926477|NCT03461276|141348017|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|t-test (sensitivity hypothesis). A 1-sided t-test with a significance level of 0.025 was employed.||"1-sided t-test to compare the ABvac40 and placebo groups.~The primary analysis (t-test) was repeated, using the mITT Analysis Set to test the hypothesis:~* Null hypothesis: average MΔ anti-Aβ40 (ABvac40) - average MΔ anti-Aβ40 (placebo) ≤ 1.778~* Alternative hypothesis: average MΔ anti-Aβ40 (ABvac40) - average MΔ anti-Aβ40 (placebo) \> 1.778 The alternative hypothesis was confirmed."||||<0.0001
70926478|NCT03461276|141348017|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||"The change in anti-Aβ40 antibody signal from baseline to each post-baseline efficacy visit was analyzed using a Mixed-Model Repeated Measures (MMRM), using the mITT Analysis Set.~Dependent variable: change from baseline in anti-Aβ40 antibody signal. Fixed effects: treatment, protocol-specified visits, treatment-by-visit interaction, and amyloid positivity. Covariates: baseline anti-Aβ40 antibody signal and baseline age; Repeated measure: measures within-patient at each visit."||||<0.05
70926479|NCT03461276|141348024|OTHER||||||<|0.001|||||||Mixed Models Analysis|||MMRM - Week 50A||||<0.001
70926480|NCT03461276|141348024|OTHER||||||=|0.047|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.047
70926481|NCT03461276|141348025|OTHER||||||=|0.9936|||||||Mixed Models Analysis|||MMRM - Week 2A||||= 0.9936
70926482|NCT03461276|141348025|OTHER||||||=|0.0391||||||MMRM - Week 6A|Mixed Models Analysis|||MMRM - Week 6A||||= 0.0391
70926483|NCT03461276|141348025|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 10A||||< 0.0001
70926484|NCT03461276|141348025|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 14A||||< 0.0001
70926485|NCT03461276|141348025|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 18A||||< 0.0001
70926486|NCT03461276|141348025|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 24A||||< 0.0001
70926487|NCT03461276|141348025|OTHER||||||=|0.0299|||||||Mixed Models Analysis|||MMRM - Week 40A||||= 0.0299
70926488|NCT03461276|141348025|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 44A||||< 0.0001
70926489|NCT03461276|141348025|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 50A||||< 0.0001
70926490|NCT03461276|141348025|OTHER||||||=|0.1267|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.1267
70926491|NCT03461276|141348025|OTHER|MMRM - Week 104A|||||=|0.2477|||||||Mixed Models Analysis|||||||= 0.2477
70926492|NCT03461276|141348026|OTHER||||||=|0.2151|||||||Mixed Models Analysis|||MMRM - Week 2A||||= 0.2151
70926493|NCT03461276|141348026|OTHER||||||=|0.0169|||||||Mixed Models Analysis|||MMRM - Week 6A||||= 0.0169
70926494|NCT03461276|141348026|OTHER||||||=|0.0008|||||||Mixed Models Analysis|||MMRM - Week 10A||||= 0.0008
70926495|NCT03461276|141348026|OTHER||||||=|0.0002|||||||Mixed Models Analysis|||MMRM - Week 14A||||= 0.0002
70926496|NCT03461276|141348026|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 18A||||< 0.0001
70926497|NCT03461276|141348026|OTHER||||||=|0.0023|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.0023
70926498|NCT03461276|141348026|OTHER||||||=|0.0021|||||||Mixed Models Analysis|||MMRM - Week 40A||||= 0.0021
70926499|NCT03461276|141348026|OTHER||||||=|0.0007|||||||Mixed Models Analysis|||MMRM - Week 44A||||= 0.0007
70926500|NCT03461276|141348026|OTHER||||||=|0.0012|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.0012
70926501|NCT03461276|141348026|OTHER||||||=|0.0018|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.0018
70926502|NCT03461276|141348026|OTHER||||||=|0.738|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.738
70926503|NCT03461276|141348027|OTHER||||||=|0.7623|||||||Mixed Models Analysis|||MMRM - Week 2A||||= 0.7623
70926504|NCT03461276|141348027|OTHER||||||=|0.1506|||||||Mixed Models Analysis|||MMRM - Week 6A||||= 0.1506
70926505|NCT03461276|141348027|OTHER||||||=|0.1071|||||||Mixed Models Analysis|||MMRM - Week 10A||||= 0.1071
70926506|NCT03461276|141348027|OTHER||||||=|0.0212|||||||Mixed Models Analysis|||MMRM - Week 14A||||= 0.0212
70926507|NCT03461276|141348027|OTHER||||||=|0.0014|||||||Mixed Models Analysis|||MMRM - Week 18A||||= 0.0014
70926508|NCT03461276|141348027|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 24A||||< 0.0001
70926509|NCT03461276|141348027|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 40A||||< 0.0001
70926510|NCT03461276|141348027|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 44A||||< 0.0001
70926511|NCT03461276|141348027|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 50A||||< 0.0001
70926512|NCT03461276|141348027|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 77A||||< 0.0001
70926513|NCT03461276|141348027|OTHER||||||=|0.0251|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.0251
70926514|NCT03461276|141348028|OTHER||||||=|0.6515|||||||Mixed Models Analysis|||MMRM - Week 2A||||= 0.6515
70926515|NCT03461276|141348028|OTHER||||||=|0.7447|||||||Mixed Models Analysis|||MMRM - Week 6A||||= 0.7447
70926516|NCT03461276|141348028|OTHER||||||=|0.4518|||||||Mixed Models Analysis|||MMRM - Week 10A||||= 0.4518
70926517|NCT03461276|141348028|OTHER||||||=|0.5416|||||||Mixed Models Analysis|||MMRM - Week 14A||||= 0.5416
70926518|NCT03461276|141348028|OTHER||||||=|0.3504|||||||Mixed Models Analysis|||MMRM - Week 18A||||= 0.3504
70926519|NCT03461276|141348028|OTHER||||||=|0.2109|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.2109
70926520|NCT03461276|141348028|OTHER||||||=|0.0049|||||||Mixed Models Analysis|||MMRM - Week 40A||||= 0.0049
70926521|NCT03461276|141348028|OTHER||||||=|0.0498|||||||Mixed Models Analysis|||MMRM - Week 44A||||= 0.0498
70926522|NCT03461276|141348028|OTHER||||||=|0.2181|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.2181
70926523|NCT03461276|141348028|OTHER||||||=|0.2087|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.2087
70926524|NCT03461276|141348028|OTHER||||||=|0.8599|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.8599
70926525|NCT03461276|141348029|OTHER||||||=|0.9469|||||||Mixed Models Analysis|||MMRM - Week 2A||||= 0.9469
70926526|NCT03461276|141348029|OTHER||||||=|0.9063|||||||Mixed Models Analysis|||MMRM - Week 6A||||= 0.9063
70926527|NCT03461276|141348029|OTHER||||||=|0.3418|||||||Mixed Models Analysis|||MMRM - Week 10A||||= 0.3418
70926528|NCT03461276|141348029|OTHER||||||=|0.0236|||||||Mixed Models Analysis|||MMRM - Week 14A||||= 0.0236
70926529|NCT03461276|141348029|OTHER||||||=|0.0012|||||||Mixed Models Analysis|||MMRM - Week 18A||||= 0.0012
70926530|NCT03461276|141348029|OTHER||||||=|0.0004|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.0004
70926531|NCT03461276|141348029|OTHER||||||=|0.0008|||||||Mixed Models Analysis|||MMRM - Week 40A||||= 0.0008
70926532|NCT03461276|141348029|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 44A||||< 0.0001
70926533|NCT03461276|141348029|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 50A||||< 0.0001
70926534|NCT03461276|141348029|OTHER||||||=|0.1255|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.1255
70926535|NCT03461276|141348029|OTHER||||||=|0.4232|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.4232
70926536|NCT03461276|141348030|OTHER||||||=|0.9211|||||||Mixed Models Analysis|||MMRM - Week 2A||||= 0.9211
70926537|NCT03461276|141348030|OTHER||||||=|0.2817|||||||Mixed Models Analysis|||MMRM - Week 6A||||= 0.2817
70926538|NCT03461276|141348030|OTHER||||||=|0.2984|||||||Mixed Models Analysis|||MMRM - Week 10A||||= 0.2984
70926539|NCT03461276|141348030|OTHER||||||=|0.8402|||||||Mixed Models Analysis|||MMRM - Week 14A||||= 0.8402
70926540|NCT03461276|141348030|OTHER||||||=|0.4428|||||||Mixed Models Analysis|||MMRM - Week 18A||||= 0.4428
70926541|NCT03461276|141348030|OTHER||||||=|0.4156|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.4156
70926542|NCT03461276|141348030|OTHER||||||=|0.8706|||||||Mixed Models Analysis|||MMRM - Week 40A||||= 0.8706
70926543|NCT03461276|141348030|OTHER||||||=|0.8691|||||||Mixed Models Analysis|||MMRM - Week 44A||||= 0.8691
70926544|NCT03461276|141348030|OTHER||||||=|0.2188|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.2188
70926545|NCT03461276|141348030|OTHER||||||=|0.1448|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.1448
70926546|NCT03461276|141348030|OTHER||||||=|0.5004|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.5004
70926547|NCT03461276|141348031|OTHER||||||=|0.1058|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.1058
70926548|NCT03461276|141348031|OTHER||||||=|0.0922|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.0922
70926549|NCT03461276|141348032|OTHER||||||=|0.9313|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.9313
70926550|NCT03461276|141348032|OTHER||||||=|0.2243|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.2243
70926551|NCT03461276|141348032|OTHER||||||=|0.0952|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.0952
70926552|NCT03461276|141348033|OTHER||||||=|0.3599|||||||Mixed Models Analysis|||MMRM - Week 24A - left||||= 0.3599
70926553|NCT03461276|141348033|OTHER||||||=|0.8913|||||||Mixed Models Analysis|||MMRM - Week 50A - left||||= 0.8913
70926554|NCT03461276|141348033|OTHER||||||=|0.4736|||||||Mixed Models Analysis|||MMRM - Week 104A - left||||= 0.4736
70926555|NCT03461276|141348033|OTHER||||||=|0.9095|||||||Mixed Models Analysis|||MMRM - Week 24A - right||||= 0.9095
70926556|NCT03461276|141348033|OTHER||||||=|0.8744|||||||Mixed Models Analysis|||MMRM - Week 50A - right||||= 0.8744
70926557|NCT03461276|141348033|OTHER||||||=|0.9307|||||||Mixed Models Analysis|||MMRM - Week 104A - right||||= 0.9307
70926558|NCT03461276|141348034|OTHER||||||=|0.3982|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.3982
70926559|NCT03461276|141348034|OTHER||||||=|0.7035|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.7035
70926560|NCT03461276|141348034|OTHER||||||=|0.6334|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.6334
70926561|NCT03461276|141348035|OTHER||||||=|0.2193|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.2193
70926562|NCT03461276|141348035|OTHER||||||=|0.5543|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.5543
70926563|NCT03461276|141348036|OTHER||||||=|0.7324|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.7324
70926564|NCT03461276|141348036|OTHER||||||=|0.1719|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.1719
70926565|NCT03461276|141348037|OTHER||||||=|0.7977|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.7977
70926566|NCT03461276|141348037|OTHER||||||=|0.8828|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.8828
70926567|NCT03461276|141348038|OTHER||||||=|0.7954|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.7954
70926568|NCT03461276|141348038|OTHER||||||=|0.5895|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.5895
70926569|NCT03461276|141348039|OTHER||||||=|0.743|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.743
70926570|NCT03461276|141348039|OTHER||||||=|0.832|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.832
70926571|NCT03461276|141348040|OTHER||||||=|0.2283|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.2283
70926572|NCT03461276|141348040|OTHER||||||=|0.886|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.886
70926573|NCT03461276|141348041|OTHER||||||=|0.909|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.909
70926574|NCT03461276|141348041|OTHER||||||=|0.8498|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.8498
70926575|NCT03461276|141348042|OTHER||||||=|0.8711|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.8711
70926576|NCT03461276|141348042|OTHER||||||=|0.1098|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.1098
70926577|NCT03461276|141348042|OTHER||||||=|0.6179|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.6179
70926578|NCT03461276|141348042|OTHER||||||=|0.3715|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.3715
70926579|NCT03461276|141348043|OTHER||||||=|0.8949|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.8949
70926580|NCT03461276|141348043|OTHER||||||=|0.8712|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.8712
70926581|NCT03461276|141348043|OTHER||||||=|0.8748|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.8748
70926582|NCT03461276|141348043|OTHER||||||=|0.6402|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.6402
70926583|NCT03461276|141348044|OTHER||||||=|0.552|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.552
70926584|NCT03461276|141348044|OTHER||||||=|0.9371|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.9371
70926585|NCT03461276|141348044|OTHER||||||=|0.2354|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.2354
70926586|NCT03461276|141348044|OTHER||||||=|0.4608|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.4608
70926587|NCT03461276|141348045|OTHER||||||=|0.3246|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.3246
70926588|NCT03461276|141348045|OTHER||||||=|0.8047|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.8047
70926589|NCT03461276|141348045|OTHER||||||=|0.916|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.916
70926590|NCT03461276|141348045|OTHER||||||=|0.9582|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.9582
70926591|NCT03461276|141348046|OTHER||||||=|0.777|||||||Mixed Models Analysis|||MMRM - Week 24A - Trail A||||= 0.777
70926592|NCT03461276|141348046|OTHER||||||=|0.1727|||||||Mixed Models Analysis|||MMRM - Week 50A - Trail A||||= 0.1727
71046134|NCT01642914|141600565|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.23||||0.0264|TWO_SIDED|95.0|1.09|4.56||p-values were obtained from the Cochran-Mantel-Haenszel tests controlling for geographic region, comparing each linaclotide dose versus placebo in a pairwise manner.|Cochran-Mantel-Haenszel|||||4.56|1.09|0.0264
71046135|NCT00754442|141600603|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1|TWO_SIDED|95.0||||see above|t-test, 2 sided|95%||The null hypothesis is that there is no statistical difference between patients and controls at baseline||||0.1
71046136|NCT00754442|141600603|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|95.0|||||t-test, 2 sided|||The null hypothesis is that there is no statistical difference between patients and controls at 4 hours||||0.002
70926593|NCT03461276|141348046|OTHER||||||=|0.0218|||||||Mixed Models Analysis|||MMRM - Week 77A - Trail A||||= 0.0218
70926594|NCT03461276|141348046|OTHER||||||=|0.2789|||||||Mixed Models Analysis|||MMRM - Week 104A - Trail A||||= 0.2789
70926595|NCT03461276|141348046|OTHER||||||=|0.2261|||||||Mixed Models Analysis|||MMRM - Week 24A - Trail B||||= 0.2261
70926596|NCT03461276|141348046|OTHER||||||=|0.9743|||||||Mixed Models Analysis|||MMRM - Week 50A - Trail B||||= 0.9743
70926597|NCT03461276|141348046|OTHER||||||=|0.2556|||||||Mixed Models Analysis|||MMRM - Week 77A - Trail B||||= 0.2556
70926598|NCT03461276|141348046|OTHER||||||=|0.1008|||||||Mixed Models Analysis|||MMRM - Week 104A - Trail B||||= 0.1008
70926599|NCT03461276|141348047|OTHER||||||=|0.6189|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.6189
70926600|NCT03461276|141348047|OTHER||||||=|0.6937|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.6937
70926601|NCT03461276|141348047|OTHER||||||=|0.6981|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.6981
70926602|NCT03461276|141348049|OTHER||||||=|0.2863|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.2863
70926603|NCT03461276|141348049|OTHER||||||=|0.3703|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.3703
70926604|NCT03461276|141348050|OTHER||||||=|0.9663|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.9663
70926605|NCT03461276|141348050|OTHER||||||=|0.3843|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.3843
70926606|NCT03461276|141348051|SUPERIORITY||||||<|0.0001||||||A 1-sided t-test with a significance level of 0.025 was employed.|t-test, 1 sided|||"The trial was considered successfully confirmatory regarding efficacy (immunogenicity) of ABvac40 if the average MΔ of anti-Aβ40 antibody signal (OD in ELISA) in the ABvac40 group was significantly greater than the average MΔ of anti-Aβ40 antibody signal in the Placebo group. i.e.~* Null hypothesis: average MΔ anti-Aβ40 (ABvac40) ≤ average MΔ anti-Aβ40 (placebo).~* Alternative hypothesis: average MΔ anti-Aβ40 (ABvac40) \> average MΔ anti-Aβ40 (placebo)"||||< 0.0001
70926607|NCT03461276|141348051|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
70926608|NCT03461276|141348051|SUPERIORITY||Mean Difference (Final Values)|3.21|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|3.02|3.4|||ANCOVA|||||3.4|3.02|< 0.0001
70926609|NCT02310646|141348053|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||||||Treatment sequence effect: p=0.28; gender effect: p=0.20; threshold for statistical significance: p\<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and gender as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: gender (male, female)."||||0.2
70926610|NCT02310646|141348053|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.001||||||Treatment sequence effect: p=0.34; age effect: p=0.001; threshold for statistical significance: p\<0.05.|Regression, Logistic|2-factor logistic regression with age and treatment sequence as factors||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: age (18-39 years, 40-59 years, ≥60 years)."||||=0.001
71046137|NCT00754442|141600603|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0|||||t-test, 2 sided|||The null hypothesis is that there is no statistical difference between patients and controls at 8 hrs||||0.003
70926611|NCT02310646|141348053|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||Treatment sequence effect: p=0.34; baseline disease severity effect: p=0.29; threshold for statistical significance: p\<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and baseline disease severity as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: Baseline disease severity (mild, moderate, severe)."||||0.29
70926612|NCT02310646|141348053|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||||||Treatment sequence effect: p=0.33; distribution phenotype (localised, widespread) effect: p=0.55; threshold for statistical significance: p\<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and distribution phenotype (localised, widespread) as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: distribution phenotype (localised, widespread)."||||0.55
70926613|NCT02310646|141348053|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25||||||Treatment sequence effect: p=0.32; plaque size (≤3 mm diameter, \>3 mm diameter): p=0.25; threshold for statistical significance: p\<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and plaque size as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: plaque size (≤3 mm diameter, \>3 mm diameter)."||||0.25
70926614|NCT02310646|141348053|SUPERIORITY_OR_OTHER_LEGACY|||||||0.41||||||Treatment sequence effect: p=0.34; skin thickness phenotype (≤0.75 mm, \>0.75 mm) effect: p=0.41; threshold for statistical significance: p\<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and skin thickness phenotype as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: skin thickness phenotype (≤0.75 mm, \>0.75 mm)."||||0.41
70926615|NCT02310646|141348053|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||||||Treatment sequence effect: p=0.30; onset phenotype (≤40 years of age, \>40 years of age) effect: p=0.20; threshold for statistical significance: p\<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and onset phenotype (≤40 years of age, \>40 years of age) as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: onset phenotype (≤40 years of age, \>40 years of age)."||||0.20
70926616|NCT02310646|141348054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||||||"The total TPUQ score for the gel and the foam (mean score 29.9 vs. mean score 26.8; p=0.007).~Threshold for statistical significance: p\<0.05."|Wilcoxon Rank Sum Test|Wilcoxon rank sum test comparing the period difference (within subject difference between study treatments) between both treatment sequences.||Subjects in the analysis are 212 - full analysis set. All subjects received both study treatments. Total TPUQ score (summary score item 1-25) superiority comparison gel versus foam.||||0.007
70926617|NCT02310646|141348055|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon Signed Rank Test|Wilcoxon signed rank test comparing within subject difference to latest topical treatment||Subjects in the analysis are 118. All subjects received both study treatments. Statistical analysis for total TPUQ score (summary score item 1-25): superiority comparison foam versus latest topical treatment.||||<0.001
70926618|NCT02310646|141348055|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon Signed Rank Test|Wilcoxon signed rank test comparing within subject difference to latest topical treatment||Subjects in the analysis are 118. All subjects received both study treatments. Statistical analysis for total TPUQ score (summary score item 1-25): superiority comparison gel versus latest topical treatment.||||<0.001
70926619|NCT03865498|141348059|SUPERIORITY||Odds Ratio (OR)|7.029|||<|0.0001|TWO_SIDED|95.0|4.919|10.323||McNemar's Chi-squared test (paired) with continuity correction to the test slightly more conservative|McNemar|||Hypothesis: There will be significant pre/post-intervention differences in isolated macro-level network structures for African American dementia caregiver networks.||10.323|4.919|< 0.0001
70926620|NCT03865498|141348059|SUPERIORITY||Odds Ratio (OR)|17.385|||<|0.0001|TWO_SIDED|95.0|9.963|33.157||McNemar's Chi-squared test (paired) with continuity correction to the test slightly more conservative|McNemar|||Hypothesis: There will be significant pre/post-intervention differences in isolated macro-level network structures for Hispanic dementia caregiver networks.||33.157|9.963|<0.0001
71009818|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|3.0|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-5.4|11.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose PM||11.3|-5.4|
71009819|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|1.5|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-6.1|9.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 9, pre-dose AM||9.1|-6.1|
71046138|NCT00296491|141600605|SUPERIORITY_OR_OTHER||Mean Difference (Net)|23.2|STANDARD_ERROR_OF_MEAN|5.41|<|0.001||95.0|12.5|33.8|||t-test, 2 sided||Treatment Difference = FSC - MON|||33.8|12.5|<0.001
71009820|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|2.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-5.3|9.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 9, pre-dose AM||9.9|-5.3|
71009821|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|4.3|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-4.0|12.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 10, pre-dose||12.6|-4.0|
71009822|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|5.1|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-3.2|13.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 10, pre-dose AM||13.4|-3.2|
71009823|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|-1.5|STANDARD_ERROR_OF_MEAN|4.6|||TWO_SIDED|95.0|-11.0|8.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 11, pre-dose AM||8.0|-11.0|
71009824|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|-0.9|STANDARD_ERROR_OF_MEAN|4.6|||TWO_SIDED|95.0|-10.3|8.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 11, pre-dose AM||8.6|-10.3|
71009825|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|2.9|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-7.7|13.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 12, pre-dose AM||13.4|-7.7|
71009826|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|1.2|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-9.4|11.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 12, pre-dose AM||11.8|-9.4|
71009827|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|1.0|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-8.4|10.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose AM||10.3|-8.4|
70926621|NCT03865498|141348059|SUPERIORITY||Odds Ratio (OR)|1.021||||0.924|TWO_SIDED|95.0|0.787|1.325||Pearson's Chi-squared test with Yates' continuity correction|Chi-squared, Corrected|||There will be no significant differences in isolated macro-level network structure from Tweets between Hispanic and African American dementia caregiver networks.||1.325|0.787|0.924
70926622|NCT03865498|141348060|SUPERIORITY|Pre-post mean difference|Mean Difference (Final Values)|0.628|||<|0.0001|TWO_SIDED|95.0|0.513|0.742|||a paired t-test|||Hypothesis: There will be significant pre/post-intervention differences in emotional valence score detected from Tweets for African American dementia caregiver networks.||0.742|0.513|<0.0001
70926623|NCT03865498|141348060|SUPERIORITY|Pre-post mean difference|Mean Difference (Final Values)|1.41|||<|0.0001|TWO_SIDED|95.0|1.189|1.631|||a paired t-test|||Hypothesis: There will be significant pre/post-intervention differences in emotional valence score detected from Tweets for Hispanic dementia caregiver networks.||1.631|1.189|<0.0001
70926624|NCT03865498|141348060|SUPERIORITY||Mean Difference (Final Values)|0.039||||0.6|TWO_SIDED|95.0|-0.186|0.107|||t-test, 2 sided|||There will be no significant differences in emotional valence score detected from Tweets between Hispanic and African American dementia caregiver networks.||0.107|-0.186|0.600
71009828|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|0.1|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-9.3|9.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose AM||9.4|-9.3|
71009829|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|7.0|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-1.3|15.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 1 hour||15.3|-1.3|
71009830|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|9.9|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|1.6|18.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 1 hour||18.2|1.6|
71009831|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|5.6|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-1.0|12.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 4 hour||12.3|-1.0|
71009832|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|7.2|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|0.5|13.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 4 hour||13.9|0.5|
71009833|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-8.4|7.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose PM||7.4|-8.4|
71009834|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|1.9|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-6.0|9.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose PM||9.9|-6.0|
71009835|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|3.9|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-4.0|11.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, pre-dose AM||11.8|-4.0|
71009836|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|3.3|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-4.6|11.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, pre-dose AM||11.2|-4.6|
71009837|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-8.0|7.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 15, Discharge||7.3|-8.0|
70926625|NCT05486078|141348157|OTHER|Repeated measures ANOVA||||||0.001|||||||ANOVA|||Hip abduction strength was analyzed using repeated measures ANOVA. The assumption of sphericity was tested and Bonferroni correction was applied for pairwise comparisons. A p-value \< 0.001 was considered statistically significant.||||0.001
70926626|NCT05486078|141348158|OTHER|McNemar Exact Test|||||<|0.0001||||||P-value derived from McNemar exact test comparing binary outcome (improved vs. unchanged). Statistical significance threshold set at p \< 0.05.|McNemar|McNemar Exact Test||MRI improvement was assessed using paired evaluation of inflammatory signs (edema) at baseline and Week 24. McNemar exact test was used for within-subject categorical comparison.||||< 0.0001
70926627|NCT05486078|141348159|OTHER|Friedman Test Within-group||||||0.992|||||||Friedman Test Within-group|||Analgesic use (units/week) was analyzed over time using the Friedman test for repeated measures. No significant variation across follow-up visits was found.||||0.992
70926628|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.998|TWO_SIDED|95.0|-17.81|17.86|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 15 minutes post injection||17.86|-17.81|0.998
70926629|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.445|TWO_SIDED|95.0|-24.73|10.93||The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.|Mixed Model Repeated Measures.|||Outcome Measure at 15 minutes post injection||10.93|-24.73|0.445
71046139|NCT00296491|141600606|NON_INFERIORITY_OR_EQUIVALENCE|Given estimates, and assuming a significance level of a=0.05, a sample size of 133 subjects per treatment was determined to be sufficient to provide 80% power to show equivalance.|Mean Difference (Net)|-8.9|STANDARD_ERROR_OF_MEAN|8.0|<|0.127||95.0|-24.6|6.9|||t-test, 2 sided||Treatment Difference=FSC+MON-FSC|||6.9|-24.6|<0.127
71103357|NCT00600340|141714748|SUPERIORITY|HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|1.11||||0.2583|TWO_SIDED|95.0|0.92|1.34||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab plus Capecitabine vs. Bevacizumab plus Paclitaxel for TTF (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||1.34|0.92|0.2583
71103358|NCT00600340|141714749|SUPERIORITY|HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|0.57||||0.0001|TWO_SIDED|95.0|0.43|0.77||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for TR (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||0.77|0.43|0.0001
71103359|NCT00600340|141714750|SUPERIORITY|HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|0.56||||0.0001|TWO_SIDED|95.0|0.41|0.75||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for TR (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||0.75|0.41|0.0001
71103360|NCT00600340|141714751|SUPERIORITY|HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|1.41||||0.0582|TWO_SIDED|95.0|0.99|2.02||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for DR (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||2.02|0.99|0.0582
71103361|NCT00600340|141714752|SUPERIORITY|HR is the hazard rate of Arm B divided by hazard rate of Arm A.|Hazard Ratio (HR)|1.45||||0.0429|TWO_SIDED|95.0|1.01|2.1||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Arm B divided by hazard rate of Arm A.|"HR of Arm B vs. Arm A for DR (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||2.10|1.01|0.0429
71103362|NCT02314923|141714761|OTHER|||||||0.951|||||||ANOVA|||||||0.951
70926630|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|2.51||||0.781|TWO_SIDED|95.0|-15.33|20.36||The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.|Mixed Model Repeated Measures.|||Outcome Measure at 15 minutes post injection||20.36|-15.33|0.781
71103363|NCT02314923|141714761|OTHER|||||||0.458|||||||ANOVA|||||||0.458
71103364|NCT02314923|141714761|OTHER|||||||0.071|||||||ANOVA|||||||0.071
71103365|NCT02314923|141714761|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71103366|NCT02314923|141714761|OTHER|||||||0.029|||||||ANOVA|||||||0.029
71103367|NCT02314923|141714761|OTHER|||||||0.325|||||||ANOVA|||||||0.325
71103368|NCT02314923|141714761|OTHER|||||||0.003|||||||ANOVA|||||||0.003
70926631|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|-3.09||||0.732|TWO_SIDED|95.0|-20.93|14.75||The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.|Mixed Model Repeated Measures.|||Outcome Measure at 15 minutes post injection||14.75|-20.93|0.732
71009838|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|0.5|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-7.2|8.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 15, Discharge||8.1|-7.2|
71009839|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|95.0|-11.5|10.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 21, Follow-up||10.2|-11.5|
71009840|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|6.7|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|95.0|-4.1|17.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 21, Follow-up||17.5|-4.1|
71009841|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-9.1|9.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 42, End of trial||9.6|-9.1|
71103369|NCT02314923|141714761|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71103370|NCT02314923|141714761|OTHER|||||||0.427|||||||ANOVA|||||||0.427
71103371|NCT02314923|141714761|OTHER|||||||0.065|||||||ANOVA|||||||0.065
71103372|NCT02314923|141714761|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71103373|NCT02314923|141714761|OTHER|||||||0.027|||||||ANOVA|||||||0.027
71009842|NCT03091920|141526960|OTHER|No statistical testing was performed.|Least squares mean difference|0.8|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-8.5|10.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 42, End of trial||10.2|-8.5|
71009843|NCT03091920|141526965|OTHER|No statistical testing was performed.|Least squares mean difference|-3.32|STANDARD_ERROR_OF_MEAN|3.07|||TWO_SIDED|95.0|-9.68|3.04|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1||3.04|-9.68|
70926632|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|11.3||||0.212|TWO_SIDED|95.0|-6.53|29.14||The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.|Mixed Model Repeated Measures.|||Outcome Measure at 15 minutes post injection||29.14|-6.53|0.212
70926633|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|-6.44||||0.476|TWO_SIDED|95.0|-24.27|11.39|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 15 minutes post injection||11.39|-24.27|0.476
70926634|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|0.43||||0.962|TWO_SIDED|95.0|-17.4|18.26|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 15 minutes post injection||18.26|-17.40|0.962
70926635|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|12.1||||0.211|TWO_SIDED|95.0|-6.96|31.16|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||31.16|-6.96|0.211
70926636|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|2.67||||0.782|TWO_SIDED|95.0|-16.4|21.73|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||21.73|-16.40|0.782
70926637|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|14.72||||0.129|TWO_SIDED|95.0|-4.34|33.78|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||33.78|-4.34|0.129
70926638|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|13.27||||0.171|TWO_SIDED|95.0|-5.8|32.35|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||32.35|-5.80|0.171
70926639|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|15.56||||0.108|TWO_SIDED|95.0|-3.49|34.62|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||34.62|-3.49|0.108
70926640|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|4.24||||0.661|TWO_SIDED|95.0|-14.83|23.3|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||23.30|-14.83|0.661
70926641|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|14.21||||0.142|TWO_SIDED|95.0|-4.85|33.27|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||33.27|-4.85|0.142
70926642|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|11.98||||0.216|TWO_SIDED|95.0|-7.08|31.04|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||31.04|-7.08|0.216
70926643|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|7.38||||0.445|TWO_SIDED|95.0|-11.71|26.48|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||26.48|-11.71|0.445
70926644|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|16.13||||0.096|TWO_SIDED|95.0|-2.92|35.19|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||35.19|-2.92|0.096
71046140|NCT01300052|141600615|SUPERIORITY_OR_OTHER||Difference in Percentage|3.8|||||TWO_SIDED|95.0|-14.3|21.8||||||Difference in percentage was calculated as values of AN2728 Ointment, 2% group minus values of AN2728 Ointment, Vehicle group.||21.8|-14.3|
70926645|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|11.89||||0.22|TWO_SIDED|95.0|-7.19|30.96|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||30.96|-7.19|0.220
70926646|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|12.71||||0.189|TWO_SIDED|95.0|-6.35|31.78|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||31.78|-6.35|0.189
71009844|NCT03091920|141526965|OTHER|No statistical testing was performed.|Least squares mean difference|-2.55|STANDARD_ERROR_OF_MEAN|2.99|||TWO_SIDED|95.0|-8.76|3.66|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1||3.66|-8.76|
71009845|NCT03091920|141526965|OTHER|No statistical testing was performed.|Least squares mean difference|-2.93|STANDARD_ERROR_OF_MEAN|2.74|||TWO_SIDED|95.0|-8.62|2.75|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1||2.75|-8.62|
71009846|NCT03091920|141526965|OTHER|No statistical testing was performed.|Least squares mean difference|-3.23|STANDARD_ERROR_OF_MEAN|3.44|||TWO_SIDED|95.0|-10.37|3.92|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 7||3.92|-10.37|
71009847|NCT03091920|141526965|OTHER|No statistical testing was performed.|Least squares mean difference|0.52|STANDARD_ERROR_OF_MEAN|3.36|||TWO_SIDED|95.0|-6.46|7.49|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 7||7.49|-6.46|
71009848|NCT03091920|141526965|OTHER|No statistical testing was performed.|Least squares mean difference|-1.36|STANDARD_ERROR_OF_MEAN|3.08|||TWO_SIDED|95.0|-7.74|5.03|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 7||5.03|-7.74|
71009849|NCT03091920|141526965|OTHER|No statistical testing was performed.|Least squares mean difference|-2.71|STANDARD_ERROR_OF_MEAN|4.21|||TWO_SIDED|95.0|-11.46|6.04|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 14||6.04|-11.46|
71009850|NCT03091920|141526965|OTHER|No statistical testing was performed.|Least squares mean difference|-1.87|STANDARD_ERROR_OF_MEAN|3.95|||TWO_SIDED|95.0|-10.09|6.35|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 14||6.35|-10.09|
71009851|NCT03091920|141526965|OTHER|No statistical testing was performed.|Least squares mean difference|-2.29|STANDARD_ERROR_OF_MEAN|3.67|||TWO_SIDED|95.0|-9.93|5.35|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 14||5.35|-9.93|
71009852|NCT03091920|141526966|OTHER|No statistical testing was performed.|Least squares mean difference|-7.06|STANDARD_ERROR_OF_MEAN|3.6|||TWO_SIDED|95.0|-14.52|0.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||0.40|-14.52|
71103374|NCT02314923|141714761|OTHER|||||||0.303|||||||ANOVA|||||||0.303
71009853|NCT03091920|141526966|OTHER|No statistical testing was performed.|Least squares mean difference|-4.19|STANDARD_ERROR_OF_MEAN|3.54|||TWO_SIDED|95.0|-11.52|3.14|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||3.14|-11.52|
71009854|NCT03091920|141526966|OTHER|No statistical testing was performed.|Least squares mean difference|-3.82|STANDARD_ERROR_OF_MEAN|3.69|||TWO_SIDED|95.0|-11.47|3.83|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||3.83|-11.47|
71009855|NCT03091920|141526966|OTHER|No statistical testing was performed.|Least squares mean difference|1.42|STANDARD_ERROR_OF_MEAN|3.63|||TWO_SIDED|95.0|-6.1|8.94|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||8.94|-6.10|
71046141|NCT01231373|141600622|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.34|||<|0.0001|TWO_SIDED|95.0|-4.63|-2.04|||ANCOVA|||Comparison of polidocanol treatment groups versus placebo (absolute change from baseline to week 8 in patient assessment of symptoms of varicose veins (VVSymQ) score.||-2.04|-4.63|<0.0001
71046142|NCT01231373|141600622|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.0|||<|0.0001|TWO_SIDED|95.0|-5.26|-2.74|||ANCOVA|||||-2.74|-5.26|<0.0001
71046143|NCT01231373|141600622|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.05|||<|0.0001|TWO_SIDED|95.0|-4.33|-1.77|||ANCOVA|||||-1.77|-4.33|<0.0001
71046144|NCT01231373|141600623|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.081|<|0.0001|TWO_SIDED|95.0|-0.88|-0.45|||ANCOVA|||||-0.45|-0.88|<0.0001
71046145|NCT01231373|141600623|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.078|<|0.0001|TWO_SIDED|95.0|-1.04|-0.61|||ANCOVA|||||-0.61|-1.04|<0.0001
71009856|NCT03091920|141526966|OTHER|No statistical testing was performed.|Least squares mean difference|-6.44|STANDARD_ERROR_OF_MEAN|4.77|||TWO_SIDED|95.0|-16.36|3.47|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||3.47|-16.36|
71009857|NCT03091920|141526966|OTHER|No statistical testing was performed.|Least squares mean difference|-1.03|STANDARD_ERROR_OF_MEAN|4.52|||TWO_SIDED|95.0|-10.44|8.38|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||8.38|-10.44|
71009858|NCT03091920|141526967|OTHER|No statistical testing was performed.|Least squares mean difference|-0.22|STANDARD_ERROR_OF_MEAN|3.26|||TWO_SIDED|95.0|-6.97|6.54|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||6.54|-6.97|
71009859|NCT03091920|141526967|OTHER|No statistical testing was performed.|Least squares mean difference|-1.6|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-8.24|5.03|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||5.03|-8.24|
71009860|NCT03091920|141526967|OTHER|No statistical testing was performed.|Least squares mean difference|-3.12|STANDARD_ERROR_OF_MEAN|3.74|||TWO_SIDED|95.0|-10.88|4.65|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||4.65|-10.88|
71009861|NCT03091920|141526967|OTHER|No statistical testing was performed.|Least squares mean difference|-0.82|STANDARD_ERROR_OF_MEAN|3.68|||TWO_SIDED|95.0|-8.45|6.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||6.80|-8.45|
71046146|NCT01231373|141600623|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75|||<|0.0001|TWO_SIDED|95.0|-0.97|-0.54|||ANCOVA|||||-0.54|-0.97|<0.0001
71046147|NCT01231373|141600624|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|0.131|<|0.0001|TWO_SIDED|95.0|-1.59|-0.87|||ANCOVA|||||-0.87|-1.59|<0.0001
71046148|NCT01231373|141600624|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|0.129|<|0.0001|TWO_SIDED|95.0|-1.9|-1.18|||ANCOVA|||||-1.18|-1.90|<0.0001
71046149|NCT01231373|141600624|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.83|-1.11|||ANCOVA|||||-1.11|-1.83|<0.0001
71046150|NCT02312713|141600644|SUPERIORITY||Mean Difference (Final Values)|-3.36||||0.06|TWO_SIDED|95.0|-6.84|0.12|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||0.12|-6.84|0.06
71046151|NCT02312713|141600644|SUPERIORITY||Mean Difference (Final Values)|-1.59||||0.39|TWO_SIDED|95.0|-5.26|2.08|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||2.08|-5.26|0.39
71046152|NCT02312713|141600644|SUPERIORITY||Mean Difference (Final Values)|-2.7||||0.14|TWO_SIDED|95.0|-6.24|0.85|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||0.85|-6.24|0.14
71103375|NCT02314923|141714761|OTHER|||||||0.003|||||||ANOVA|||||||0.003
71103376|NCT02314923|141714761|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71103377|NCT02314923|141714761|OTHER|||||||0.286|||||||ANOVA|||||||0.286
71103378|NCT02314923|141714761|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
70926647|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|-2.67||||0.782|TWO_SIDED|95.0|-21.75|16.41|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||16.41|-21.75|0.782
70926648|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|6.1||||0.528|TWO_SIDED|95.0|-12.98|25.18|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||25.18|-12.98|0.528
70926649|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|2.34||||0.795|TWO_SIDED|95.0|-15.45|20.12|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||20.12|-15.45|0.795
70926650|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|-6.13||||0.497|TWO_SIDED|95.0|-23.96|11.69|||mean difference|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||11.69|-23.96|0.497
70926651|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|7.44||||0.409|TWO_SIDED|95.0|-10.34|25.21|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||25.21|-10.34|0.409
70926652|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|7.89||||0.382|TWO_SIDED|95.0|-9.92|25.7|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||25.70|-9.92|0.382
70926653|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|7.74||||0.39|TWO_SIDED|95.0|-10.05|25.54|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||25.54|-10.05|0.390
70926654|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|-3.72||||0.68|TWO_SIDED|95.0|-21.54|14.1|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||14.10|-21.54|0.680
71009862|NCT03091920|141526967|OTHER|No statistical testing was performed.|Least squares mean difference|0.87|STANDARD_ERROR_OF_MEAN|4.19|||TWO_SIDED|95.0|-7.84|9.58|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||9.58|-7.84|
71103379|NCT02314923|141714761|OTHER|||||||0.094|||||||ANOVA|||||||0.094
71103380|NCT02314923|141714761|OTHER|||||||0.757|||||||ANOVA|||||||0.757
71009863|NCT03091920|141526967|OTHER|No statistical testing was performed.|Least squares mean difference|-2.98|STANDARD_ERROR_OF_MEAN|3.96|||TWO_SIDED|95.0|-11.23|5.26|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||5.26|-11.23|
71103381|NCT02314923|141714761|OTHER|||||||0.022|||||||ANOVA|||||||0.022
70926655|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.927|TWO_SIDED|95.0|-16.99|18.65|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||18.65|-16.99|0.927
71009864|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|-5.55|STANDARD_ERROR_OF_MEAN|3.84|||TWO_SIDED|95.0|-13.51|2.41|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||2.41|-13.51|
70926656|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|6.02||||0.508|TWO_SIDED|95.0|-11.95|23.98||The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.|Mixed Model Repeated Measures.|||Outcome Measure at 120 minutes post injection||23.98|-11.95|0.508
71009865|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|-2.47|STANDARD_ERROR_OF_MEAN|3.83|||TWO_SIDED|95.0|-10.41|5.47|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||5.47|-10.41|
71009866|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|-8.05|STANDARD_ERROR_OF_MEAN|4.49|||TWO_SIDED|95.0|-17.36|1.25|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||1.25|-17.36|
70926657|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|-3.65||||0.688|TWO_SIDED|95.0|-21.66|14.35|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 120 minutes post injection||14.35|-21.66|0.688
70926658|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|16.08||||0.079|TWO_SIDED|95.0|-1.88|34.03|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 120 minutes post injection||34.03|-1.88|0.079
70926659|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|9.0||||0.323|TWO_SIDED|95.0|-8.96|26.96|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 120 minutes post injection||26.96|-8.96|0.323
71009867|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|-8.28|STANDARD_ERROR_OF_MEAN|4.41|||TWO_SIDED|95.0|-17.42|0.87|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||0.87|-17.42|
71103382|NCT02314923|141714761|OTHER|||||||0.001|||||||ANOVA|||||||0.001
71103383|NCT02314923|141714761|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71103384|NCT02314923|141714761|OTHER|||||||0.348|||||||ANOVA|||||||0.348
71103385|NCT02314923|141714761|OTHER|||||||0.508|||||||ANOVA|||||||0.508
71103386|NCT02314923|141714761|OTHER|||||||0.191|||||||ANOVA|||||||0.191
71103387|NCT02314923|141714761|OTHER|||||||0.024|||||||ANOVA|||||||0.024
71103388|NCT02314923|141714761|OTHER|||||||0.169|||||||ANOVA|||||||0.169
71103389|NCT02314923|141714761|OTHER|||||||0.961|||||||ANOVA|||||||0.961
70926660|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|11.23||||0.183|TWO_SIDED|95.0|-5.39|27.85|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 120 minutes post injection||27.85|-5.39|0.183
70926661|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|-2.61||||0.756|TWO_SIDED|95.0|-19.24|14.02|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 120 minutes post injection||14.02|-19.24|0.756
70926662|NCT04802967|141348207|SUPERIORITY||Mean Difference (Final Values)|3.96||||0.638|TWO_SIDED|95.0|-12.68|20.59|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 120 minutes post injection||20.59|-12.68|0.638
70926663|NCT04114877|141348217|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|Linear mixed models||||||>0.05
70926664|NCT04114877|141348218|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|Linear mixed models||||||>0.05
71046153|NCT02312713|141600644|SUPERIORITY||Mean Difference (Final Values)|-2.63||||0.17|TWO_SIDED|95.0|-6.37|1.11|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||1.11|-6.37|0.17
71046154|NCT02312713|141600644|NON_INFERIORITY|The IBET intervention will be non-inferior to the standard PT intervention, indicated by a mean WOMAC score less than 5 points higher than standard PT.|Mean Difference (Final Values)|0.67||||0.65|TWO_SIDED|95.0|-2.23|3.56|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||3.56|-2.23|0.65
71046155|NCT02312713|141600644|NON_INFERIORITY|The IBET intervention will be non-inferior to the standard PT intervention, indicated by a mean WOMAC score less than 5 points higher than standard PT.|Mean Difference (Final Values)|-1.04||||0.51|TWO_SIDED|95.0|-4.13|2.05|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||2.05|-4.13|0.51
71046156|NCT02312713|141600645|SUPERIORITY||Median Difference (Final Values)|0.56||||0.01|TWO_SIDED|95.0|0.15|0.98|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||0.98|0.15|0.01
71103390|NCT02314923|141714761|OTHER|||||||0.454|||||||ANOVA|||||||0.454
71103391|NCT02314923|141714761|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71103392|NCT02314923|141714761|OTHER|||||||0.068|||||||ANOVA|||||||0.068
71103393|NCT02314923|141714761|OTHER|||||||0.007|||||||ANOVA|||||||0.007
71103394|NCT02314923|141714761|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71103395|NCT02314923|141714761|OTHER|||||||0.37|||||||ANOVA|||||||0.370
70926665|NCT04114877|141348219|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|Linear mixed models||||||>0.05
71103396|NCT02314923|141714761|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
70926666|NCT04114877|141348220|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|Linear mixed models||||||>0.05
70926667|NCT04114877|141348221|SUPERIORITY|||||||0.455|||||||Fisher Exact|||||||0.455
70926668|NCT03945292|141348222|SUPERIORITY||Difference|-66.81|STANDARD_ERROR_OF_MEAN|5.107|<|0.0001|TWO_SIDED|95.0|-77.18|-56.45||From a mixed model with repeated measures, including fixed effects for treatment, week, treatment-by-week interaction, presence of metabolic syndrome, presence of NAFLD or NASH, baseline serum Z-AAT as covariate, and subject as a random effect.|Mixed model repeated measures (MMRM)|NAFLD=non-alcoholic fatty liver disease; NSH=non-alcoholic steatohepatitis||||-56.45|-77.18|< 0.0001
70926669|NCT03945292|141348222|SUPERIORITY||Difference|-90.03|STANDARD_ERROR_OF_MEAN|5.26|<|0.0001|TWO_SIDED|95.0|-100.72|-79.34||From a mixed model with repeated measures, including fixed effects for treatment, week, treatment-by-week interaction, presence of metabolic syndrome, presence of NAFLD or NASH, baseline serum Z-AAT as covariate, and subject as a random effect.|MMRM|||||-79.34|-100.72|< 0.0001
70926670|NCT03945292|141348222|SUPERIORITY||Difference|-97.57|STANDARD_ERROR_OF_MEAN|5.24|<|0.0001|TWO_SIDED|95.0|-108.21|-86.94||From a mixed model with repeated measures, including fixed effects for treatment, week, treatment-by-week interaction, presence of metabolic syndrome, presence of NAFLD or NASH, baseline serum Z-AAT as covariate, and subject as a random effect.|MMRM|||||-86.94|-108.21|< 0.0001
70926671|NCT03945292|141348226|SUPERIORITY||Least Squares (LS) Mean Difference|-129.31|STANDARD_ERROR_OF_MEAN|36.409||0.0021|TWO_SIDED|95.0|-205.52|-53.11||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline total liver Z-AAT protein as a covariate.|ANCOVA|||||-53.11|-205.52|0.0021
71046157|NCT02312713|141600645|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.28|TWO_SIDED|95.0|-0.19|0.65|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||0.65|-0.19|0.28
71103397|NCT00725985|141714766|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.381|||<|0.0001|TWO_SIDED|95.0|0.248|0.584||The treatment effect was also assessed by hazard ratios using the Cox's proportional hazards model.|two-sided Wald test|||||0.584|0.248|<0.0001
71103398|NCT00725985|141714766|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.327|||<|0.0001|TWO_SIDED|95.0|0.21|0.509||The treatment effect was also assessed by hazard ratios using the Cox's proportional hazards model.|two-sided Wald test|||||0.509|0.210|< 0.0001
71103399|NCT00725985|141714767|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.425|||<|0.0001|TWO_SIDED|95.0|0.331|0.547||The treatment effect was also assessed by hazard ratios using the Cox's proportional hazards model.|two-sided Wald test|||||0.547|0.331|< 0.0001
71103400|NCT00725985|141714767|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.497|||<|0.0001|TWO_SIDED|95.0|0.39|0.633||The treatment effect was also assessed by hazard ratios using the Cox's proportional hazards model.|two-sided Wald test|||||0.633|0.390|< 0.0001
71103401|NCT00725985|141714768|SUPERIORITY||Median Difference (Final Values)|-0.667|||<|0.0001|TWO_SIDED|95.0|-0.971|-0.5|||ANCOVA|||CUA lesions||-0.500|-0.971|<0.0001
71103402|NCT00725985|141714768|SUPERIORITY||Median Difference (Final Values)|-0.625|||<|0.0001|TWO_SIDED|95.0|-0.857|-0.429|||ANCOVA|||CUA lesions||-0.429|-0.857|<0.0001
71103403|NCT00725985|141714768|SUPERIORITY||Median Difference (Final Values)|-0.286|||<|0.0001|TWO_SIDED|95.0|-0.333|-0.167|||ANCOVA|||T1 Gd-Enhancing Lesions||-0.167|-0.333|<0.0001
70926672|NCT03945292|141348226|SUPERIORITY||LS Mean Difference|-124.03|STANDARD_ERROR_OF_MEAN|37.207||0.0035|TWO_SIDED|95.0|-201.9|-46.15||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline total liver Z-AAT protein as a covariate.|ANCOVA|||||-46.15|-201.9|0.0035
70926673|NCT03945292|141348226|SUPERIORITY||LS Mean Difference|-140.58|STANDARD_ERROR_OF_MEAN|30.906||0.0002|TWO_SIDED|95.0|-205.27|-75.89||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline total liver Z-AAT protein as a covariate.|ANCOVA|||||-75.89|-205.27|0.0002
70926674|NCT03945292|141348228|SUPERIORITY||LS Mean Difference|-98.07|STANDARD_ERROR_OF_MEAN|20.291||0.0001|TWO_SIDED|95.0|-140.53|-55.6||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline soluble liver Z-AAT protein as a covariate.|ANCOVA|||||-55.6|-140.53|0.0001
70926675|NCT03945292|141348228|SUPERIORITY||LS Mean Difference|-109.56|STANDARD_ERROR_OF_MEAN|21.616|<|0.0001|TWO_SIDED|95.0|-154.81|-64.32||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline soluble liver Z-AAT protein as a covariate.|ANCOVA|||||-64.32|-154.81|< 0.0001
70926676|NCT03945292|141348228|SUPERIORITY||LS Mean Difference|-118.04|STANDARD_ERROR_OF_MEAN|17.16|<|0.0001|TWO_SIDED|95.0|-153.95|-82.12||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline soluble liver Z-AAT protein as a covariate.|ANCOVA|||||-82.12|-153.95|< 0.0001
70926677|NCT03945292|141348230|SUPERIORITY||LS Mean Difference|-180.7|STANDARD_ERROR_OF_MEAN|74.087||0.0247|TWO_SIDED|95.0|-335.77|-25.64||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline insoluble liver Z-AAT protein as a covariate.|ANCOVA|||||-25.64|-335.77|0.0247
70926678|NCT03945292|141348230|SUPERIORITY||LS Mean Difference|-163.79|STANDARD_ERROR_OF_MEAN|73.513||0.0382|TWO_SIDED|95.0|-317.65|-9.93||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline insoluble liver Z-AAT protein as a covariate.|ANCOVA|||||-9.93|-317.65|0.0382
71103404|NCT00725985|141714768|SUPERIORITY||Median Difference (Final Values)|-0.286|||<|0.0001|TWO_SIDED|95.0|-0.375|-0.167|||ANCOVA|||T1 Gd-Enhancing Lesions||-0.167|-0.375|<0.0001
71103405|NCT00725985|141714768|SUPERIORITY||Median Difference (Final Values)|-0.333|||<|0.0001|TWO_SIDED|95.0|-0.5|-0.167|||ANCOVA|||T2 Lesions||-0.167|-0.500|<0.0001
71103406|NCT00725985|141714768|SUPERIORITY||Median Difference (Final Values)|-0.286|||<|0.0001|TWO_SIDED|95.0|-0.429|-0.143|||ANCOVA|||T2 Lesions||-0.143|-0.429|<0.0001
71103407|NCT00725985|141714787|SUPERIORITY||Point Estimate|-1.7|||<|0.0001|TWO_SIDED|95.0|-37.2|0.0|||ANCOVA|||||0.000|-37.200|<0.0001
71103408|NCT00725985|141714787|SUPERIORITY||Point Estimate|-28.6|||<|0.0001|TWO_SIDED|95.0|-117.3|0.0|||ANCOVA|||||0.000|-117.300|<0.0001
71103409|NCT00863304|141714816|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.65|-0.62||P-value was based on pairwise comparisons.|ANCOVA|||Analysis of Covariance (ANCOVA) was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.62|-1.65|<0.001
71103410|NCT00863304|141714816|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.26||0.002|TWO_SIDED|95.0|-1.32|-0.29||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.29|-1.32|0.002
70926679|NCT03945292|141348230|SUPERIORITY||LS Mean Difference|-193.2|STANDARD_ERROR_OF_MEAN|63.089||0.0064|TWO_SIDED|95.0|-325.25|-61.15||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline insoluble liver Z-AAT protein as a covariate.|ANCOVA|||||-61.15|-325.25|0.0064
70926680|NCT06429319|141348250|SUPERIORITY||F value|5.919||||0.004|TWO_SIDED|||||The threshold for statistical significance was p \<0.05.|ANCOVA|"To compare the efficacy of one and two NOLTREX™ courses was used ANCOVA adjusted for the baseline value with fixed factor of treatment group."||No sample size calculation was performed. Maximum expected number of participants for OLE was 72 patients randomized to the NOLTREX™ group in the parent study (IA/PAAG-SI/OA/2019). A total of 65 patients entered the OLE. The study did not have a formal hypothesis. The between-group comparison of changes from baseline (OLE visit 0) in the WOMAC-T at visit 5 was conducted using analysis of covariance (ANCOVA) and, as a post hoc test, the Tukey test.||||0.004
70926681|NCT06429319|141348250|SUPERIORITY||LS-means difference|-37.64|STANDARD_ERROR_OF_MEAN|56.34||0.783|TWO_SIDED|95.0|-172.98|97.7||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test|Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||97.70|-172.98|0.783
70926682|NCT06429319|141348250|SUPERIORITY||LS-means difference|81.94|STANDARD_ERROR_OF_MEAN|60.45||0.37|TWO_SIDED|95.0|-63.28|227.16|||Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||227.16|-63.28|0.370
71046158|NCT02312713|141600645|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.75|TWO_SIDED|95.0|-0.35|0.49|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||0.49|-0.35|0.75
71046159|NCT02312713|141600645|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.22|TWO_SIDED|95.0|-0.16|0.7|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||0.7|-0.16|0.22
71046160|NCT02312713|141600645|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.5||||0|TWO_SIDED|95.0|-0.84|-0.16|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||-0.16|-0.84|0.00
71046161|NCT02312713|141600645|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.04||||0.83|TWO_SIDED|95.0|-0.31|0.39|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||0.39|-0.31|0.83
71046162|NCT02312713|141600646|SUPERIORITY||Mean Difference (Final Values)|7.75||||0.04|TWO_SIDED|95.0|0.43|15.07|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for the 2 Minute Step Test.||15.07|0.43|0.04
71046163|NCT02312713|141600646|SUPERIORITY||Mean Difference (Final Values)|1.12||||0.78|TWO_SIDED|95.0|-6.59|8.82|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for the 2 Minute Step Test.||8.82|-6.59|0.78
71046164|NCT02312713|141600646|SUPERIORITY||Mean Difference (Final Values)|4.88||||0.2|TWO_SIDED|95.0|-2.56|12.33|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for the 2 Minute Step Test.||12.33|-2.56|0.20
70926683|NCT06429319|141348250|SUPERIORITY||LS-means difference|119.58|STANDARD_ERROR_OF_MEAN|34.76||0.003|TWO_SIDED|95.0|36.09|203.07||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||203.07|36.09|0.003
70926684|NCT06429319|141348250|SUPERIORITY||F value|2.78||||0.07|TWO_SIDED|||||The threshold for statistical significance was p \<0.05.|ANCOVA|"To compare the efficacy of one and two NOLTREX™ courses was used ANCOVA adjusted for the baseline value with fixed factor of treatment group."||The between-group comparison of changes from baseline (visit 1 study 1) in the WOMAC-T at visit 5 was conducted using analysis of covariance (ANCOVA) and, as a post hoc test, the Tukey test.||||0.070
70926685|NCT06429319|141348254|SUPERIORITY|||||||0.03||||||The threshold for statistical significance was p \<0.05.|Kruskal-Wallis|||"BASELINE (study 1 visit 1)~To determine a statistically significant difference between 3 groups the one-way ANOVA (for normally distributed data; aov) or the Kruskal-Wallis test (for non-normally distributed data; kw) was used. The Shapiro-Wilk test was employed to assess the normality of the data distribution."||||0.030
70926686|NCT06429319|141348254|SUPERIORITY|||||||0.002||||||The threshold for statistical significance was p \<0.05.|Kruskal-Wallis|||"BASELINE (OLE visit 0)~To determine a statistically significant difference between 3 groups the one-way ANOVA (for normally distributed data; aov) or the Kruskal-Wallis test (for non-normally distributed data; kw) was used. The Shapiro-Wilk test was employed to assess the normality of the data distribution."||||0.002
70926687|NCT06429319|141348254|SUPERIORITY|||||||0.007||||||The threshold for statistical significance was p \<0.05.|ANOVA|||"visit 3~To determine a statistically significant difference between 3 groups the one-way ANOVA (for normally distributed data; aov) or the Kruskal-Wallis test (for non-normally distributed data; kw) was used. The Shapiro-Wilk test was employed to assess the normality of the data distribution."||||0.007
70926688|NCT06429319|141348254|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p \<0.05.|Kruskal-Wallis|||"visit 5~To determine a statistically significant difference between 3 groups the one-way ANOVA (for normally distributed data; aov) or the Kruskal-Wallis test (for non-normally distributed data; kw) was used. The Shapiro-Wilk test was employed to assess the normality of the data distribution."||||<0.001
70926689|NCT06429319|141348255|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p \<0.05.|Fisher Exact|||"Fisher's exact test was used to determine whether there is a significant difference between 3 groups.~visit 3"||||<0.001
70926690|NCT06429319|141348255|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||"visit 5~Fisher's exact test was used to determine whether there is a significant difference between 3 groups."||||<0.001
70926691|NCT06429319|141348256|SUPERIORITY|||||||0.018||||||The threshold for statistical significance was p \<0.05.|Fisher Exact|||"visit 3~Fisher's exact test was used to determine whether there was a significant difference between 3 groups."||||0.018
71103411|NCT00863304|141714816|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.26||0.09|TWO_SIDED|95.0|-0.96|0.07||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.07|-0.96|0.090
71103412|NCT00863304|141714816|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.26||0.009|TWO_SIDED|95.0|-1.21|-0.17||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.17|-1.21|0.009
70926692|NCT06429319|141348256|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p \<0.05.|Fisher Exact|||"visit 5~Fisher's exact test was used to determine whether there was a significant difference between 3 groups."||||<0.001
70926693|NCT06429319|141348259|SUPERIORITY|||||||0.01||||||The threshold for statistical significance was p \<0.05.|Kruskal-Wallis|||To determine a statistically significant difference between 3 groups the one-way ANOVA (for normally distributed data; aov) or the Kruskal-Wallis test (for non-normally distributed data; kw) was used. The Shapiro-Wilk test was employed to assess the normality of the data distribution.||||0.010
70926694|NCT04295798|141348260|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.02|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task cost to gait speed from baseline to immediately post intervention.||||0.02
70926695|NCT04295798|141348261|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.02|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task cost to standing postural sway speed from baseline to immediately post intervention.||||0.02
70926696|NCT04295798|141348262|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.04|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task cost to stride time variability from baseline to immediately post intervention.||||0.04
70926697|NCT04295798|141348263|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.56|||||||ANOVA|||We hypothesized no significant effect of intervention type on absolute change in single task gait speed from baseline to immediately post intervention.||||0.56
70941330|NCT00985621|141383146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.23||0.319|TWO_SIDED|95.0|-0.69|0.22|||ANCOVA|||Change at Week 2: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.22|-0.69|0.319
71046165|NCT02312713|141600646|SUPERIORITY||Mean Difference (Final Values)|1.13||||0.78|TWO_SIDED|95.0|-6.74|8.99|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for the 2 Minute Step Test.||8.99|-6.74|.78
71046166|NCT02312713|141600646|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-2.86||||0.35|TWO_SIDED|95.0|-8.94|3.21|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for the 2 Minute Step Test.||3.21|-8.94|0.35
71046167|NCT02312713|141600646|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.01||||1|TWO_SIDED|95.0|-6.4|6.42|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for the 2 Minute Step Test.||6.42|-6.40|1.00
71046168|NCT02312713|141600647|SUPERIORITY||Mean Difference (Final Values)|-0.63||||0.19|TWO_SIDED|95.0|-1.56|0.3|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for Unilateral Stand Time.||0.30|-1.56|0.19
71046169|NCT02312713|141600647|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.93|TWO_SIDED|95.0|-0.89|0.98|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for Unilateral Stand Time.||0.98|-0.89|0.93
71046170|NCT02312713|141600647|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.97|TWO_SIDED|95.0|-0.97|0.93|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Unilateral Stand Time.||0.93|-0.97|0.97
71046171|NCT02312713|141600647|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.93|TWO_SIDED|95.0|-0.91|1.0|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Unilateral Stand Time||1|-0.91|0.93
71046172|NCT02312713|141600647|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.61||||0.12|TWO_SIDED|95.0|-0.16|1.38|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Unilateral Stand Time.||1.38|-0.16|0.12
71046173|NCT02312713|141600647|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-0.78|0.77|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Unilateral Stand Time.||0.77|-0.78|1.00
71046174|NCT02312713|141600648|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.63|TWO_SIDED|95.0|-1.55|0.94|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for 30 Second Chair Stand.||.94|-1.55|0.63
71103413|NCT00863304|141714816|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.26||0.175|TWO_SIDED|95.0|-0.87|0.16||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.16|-0.87|0.175
71046175|NCT02312713|141600648|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.37|TWO_SIDED|95.0|-1.58|0.6|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for 30 Second Chair Stand.||0.6|-1.58|0.37
71103414|NCT00863304|141714817|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.71|-0.75||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.75|-1.71|<0.001
71103415|NCT00863304|141714817|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.48|-0.51||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.51|-1.48|<0.001
71046176|NCT02312713|141600648|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.62|TWO_SIDED|95.0|-0.95|1.59|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for 30 Second Chair Stand.||1.59|-0.95|0.62
71046177|NCT02312713|141600648|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.67|TWO_SIDED|95.0|-0.87|1.35|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for 30 Second Chair Stand.||1.35|-0.87|0.67
71046178|NCT02312713|141600648|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.63||||0.23|TWO_SIDED|95.0|-0.4|1.66|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for 30 Second Chair Stand.||1.66|-0.40|0.23
71046179|NCT02312713|141600648|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.74||||0.11|TWO_SIDED|95.0|-0.17|1.64|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for 30 Second Chair Stand.||1.64|-0.17|0.11
71046180|NCT02312713|141600649|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.52|TWO_SIDED|95.0|-1.58|0.8|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for Timed Up and Go.||0.8|-1.58|0.52
70926698|NCT04295798|141348264|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.07|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task gait speed from baseline to immediately post intervention.||||0.07
70926699|NCT04295798|141348265|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.74|||||||ANOVA|||We hypothesized no significant effect of intervention type on absolute change in single task stride time variability from baseline to immediately post intervention.||||0.74
70926700|NCT04295798|141348266|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.33|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task stride time variability from baseline to immediately post intervention.||||0.33
70926701|NCT04295798|141348267|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.16|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task cost to standing postural sway area from baseline to immediately post intervention.||||0.16
70926702|NCT04295798|141348268|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.52|||||||ANOVA|||We hypothesized no significant effect of intervention type on absolute change in single task postural sway speed from baseline to immediately post intervention.||||0.52
70926703|NCT04295798|141348269|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.01|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task postural sway speed from baseline to immediately post intervention.||||0.01
71009868|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|-9.34|STANDARD_ERROR_OF_MEAN|4.86|||TWO_SIDED|95.0|-19.43|0.74|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||0.74|-19.43|
71009869|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|-3.05|STANDARD_ERROR_OF_MEAN|4.77|||TWO_SIDED|95.0|-12.95|6.84|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||6.84|-12.95|
70926704|NCT04295798|141348270|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.39|||||||ANOVA|||We hypothesized no significant effect of intervention type on absolute change in single task postural sway area from baseline to immediately post intervention||||0.39
71009870|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|3.36|STANDARD_ERROR_OF_MEAN|3.91|||TWO_SIDED|95.0|-4.74|11.47|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||11.47|-4.74|
71009871|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|2.82|STANDARD_ERROR_OF_MEAN|3.82|||TWO_SIDED|95.0|-5.1|10.75|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||10.75|-5.10|
71009872|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|-4.43|STANDARD_ERROR_OF_MEAN|5.21|||TWO_SIDED|95.0|-15.23|6.37|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||6.37|-15.23|
71009873|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|-4.85|STANDARD_ERROR_OF_MEAN|5.21|||TWO_SIDED|95.0|-15.65|5.94|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||5.94|-15.65|
70926705|NCT04295798|141348271|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.18|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task postural sway area from baseline to immediately post intervention.||||0.18
70926706|NCT00085735|141348328|NON_INFERIORITY|A hazard ratio of 1.6 is used as the non-inferiority margin. For the final analysis of comparing LDCSI vs. SDCSI, a one-sided 80% upper confidence limit of the hazard ratio based on a stratified approach will be estimated (stratified by RT group (IFRT vs. PFRT)). If the upper confidence limit is lower than 1.6, LDCSI would be deemed to be non-inferior. If not, non-inferiority would not be established.|Hazard Ratio (HR)|1.5|||||ONE_SIDED|80.0||1.9||||||The comparison is based on all eligible randomized patients 3-7 years of age without anaplastic histology or excess residual disease or disseminated disease by central review per the protocol document. Using a one-sided log rank test with type I error of 0.20, this study was designed to have power of 0.80 to detect a 10% reduction in cure rate due to the use of LDCSI compared to SDCSI.||1.9||
70926707|NCT00085735|141348328|NON_INFERIORITY|A hazard ratio of 1.6 is used as the non-inferiority margin. For the final analysis comparing IFRT vs. PFRT, a one-sided 94% upper confidence limit of the hazard ratio based on a stratified approach will be estimated (stratified by age group and RT group (LDCSI vs. SDCSI)). If the upper confidence limit is lower than 1.6, IFRT would be deemed to be non-inferior. If not, non-inferiority would not be established.|Hazard Ratio (HR)|1.0|||||ONE_SIDED|94.0||1.3||||||The comparison is based on all eligible randomized patients 3-21 years of age without anaplastic histology or excess residual disease or disseminated disease by central review as per the protocol document. Using a one-sided log rank test with type I error of 0.20, this study was designed with power of 0.94 to detect a 10% reduction in cure rate and power of 0.65 to detect a 5% reduction in cure rate, due to the use of IFRT compared to PFRT.||1.3||
70926708|NCT01824875|141348348|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.46|1.07|||||Hazard ratio of Arm B/Arm A|||1.07|0.46|
70926709|NCT01824875|141348349|SUPERIORITY|||||||0.59|||||||Fisher Exact|||||||0.59
71009874|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|-0.81|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-9.1|7.47|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||7.47|-9.10|
71009875|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|-2.63|STANDARD_ERROR_OF_MEAN|3.76|||TWO_SIDED|95.0|-10.42|5.16|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||5.16|-10.42|
71009876|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|-5.54|STANDARD_ERROR_OF_MEAN|3.98|||TWO_SIDED|95.0|-13.8|2.72|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||2.72|-13.80|
71009877|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|3.97|||TWO_SIDED|95.0|-8.25|8.23|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||8.23|-8.25|
71009878|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|-2.89|STANDARD_ERROR_OF_MEAN|4.4|||TWO_SIDED|95.0|-12.01|6.23|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||6.23|-12.01|
71009879|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|2.17|STANDARD_ERROR_OF_MEAN|4.32|||TWO_SIDED|95.0|-6.78|11.13|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||11.13|-6.78|
71009880|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|-4.23|STANDARD_ERROR_OF_MEAN|4.68|||TWO_SIDED|95.0|-13.93|5.47|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||5.47|-13.93|
71009881|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|1.37|STANDARD_ERROR_OF_MEAN|4.59|||TWO_SIDED|95.0|-8.14|10.88|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||10.88|-8.14|
71009882|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|-0.57|STANDARD_ERROR_OF_MEAN|4.7|||TWO_SIDED|95.0|-10.32|9.18|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||9.18|-10.32|
71009883|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|2.49|STANDARD_ERROR_OF_MEAN|4.6|||TWO_SIDED|95.0|-7.04|12.02|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||12.02|-7.04|
71009884|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|-7.89|STANDARD_ERROR_OF_MEAN|5.03|||TWO_SIDED|95.0|-18.33|2.55|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||2.55|-18.33|
71009885|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|-6.49|STANDARD_ERROR_OF_MEAN|5.03|||TWO_SIDED|95.0|-16.92|3.95|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||3.95|-16.92|
70926710|NCT01098812|141348356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|43.0|STANDARD_DEVIATION|75.0|<|0.0001|ONE_SIDED|90.0|25.0|||Primary study endpoint; therefore, no adjustment for multiple comparisons. The planned alpha level for testing was 0.025.|t-test, 1 sided|||Toric IOL results for mean percent reduction in cyl compared to control results at 6 months. Null hypothesis = mean reduction for toric eyes is \<= to that of control eyes; alternate hypothesis = mean reduction for toric eyes is \> the control. There is 80% power to detect \>=31% difference in mean percent reduction in cylinder (postoperative refractive cylinder minus preoperative keratometric cylinder)/(target refractive cylinder minus preoperative keratometric cylinder) between IOL groups.|||25|<0.0001
70926711|NCT01098812|141348357|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_DEVIATION|0.15||0.0009|ONE_SIDED|90.0||-0.03||P-value compared to alpha level adjusted for multiplicity of 0.0125.|t-test, 1 sided|||Used LogMAR values for visual acuity; The null hypothesis is that the mean UCDVA for toric eyes is worse than or equal to that for control eyes; the alternate hypothesis is that the mean UCDVA for toric eyes is better than that for control eyes. There is 80% power to detect \>=0.06 LogMAR difference in mean UCDVA between IOL groups.||-0.03||0.0009
70926712|NCT01715285|141348360|SUPERIORITY||Hazard Ratio (HR)|0.466|||<|0.0001|TWO_SIDED|95.0|0.394|0.55|||Log Rank|||||0.550|0.394|<0.0001
70926713|NCT01715285|141348361|SUPERIORITY||Hazard Ratio (HR)|0.661|||<|0.0001|TWO_SIDED|95.0|0.564|0.775|||Log Rank|||||0.775|0.564|< 0.0001
70926714|NCT05020249|141348382|SUPERIORITY||||||<|0.001||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||<0.001
70926715|NCT05020249|141348383|SUPERIORITY||||||<|0.001||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||<0.001
70926716|NCT05020249|141348384|SUPERIORITY|||||||0.08||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||0.080
70926717|NCT05020249|141348385|SUPERIORITY|||||||0.08||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||0.080
70926718|NCT05020249|141348386|SUPERIORITY||||||<|0.001||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||<0.001
70926719|NCT05020249|141348387|SUPERIORITY||||||<|0.001||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||<0.001
70926720|NCT05020249|141348388|SUPERIORITY||||||<|0.001||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||<0.001
71046181|NCT02312713|141600649|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.46|TWO_SIDED|95.0|-1.86|0.85|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for Timed Up and Go.||0.85|-1.86|0.46
71046182|NCT02312713|141600649|SUPERIORITY||Mean Difference (Final Values)|-0.64||||0.3|TWO_SIDED|95.0|-1.85|0.58|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Timed Up and Go.||0.58|-1.85|0.3
71046183|NCT02312713|141600649|SUPERIORITY||Mean Difference (Final Values)|-1.22||||0.08|TWO_SIDED|95.0|-2.61|0.16|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Timed Up and Go.||0.16|-2.61|0.08
70926721|NCT05020249|141348389|SUPERIORITY||||||<|0.001||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||<0.001
70926722|NCT05020249|141348390|SUPERIORITY||Odds Ratio (OR)|81.25|||<|0.001|TWO_SIDED|95.0|8.216|803.544||P-values for the comparison of treatment groups are based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio of scalp IGA response for bimekizumab group compared with placebo group using CMH.||803.544|8.216|<0.001
70926723|NCT05020249|141348391|SUPERIORITY||Odds Ratio (OR)|12.353||||0.007|TWO_SIDED|95.0|1.447|105.443||P-values for the comparison of treatment groups are based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio of DLQI total score response for bimekizumab group compared with placebo group using CMH.||105.443|1.447|0.007
71046184|NCT02312713|141600649|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.24||||0.63|TWO_SIDED|95.0|-1.23|0.74|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Timed Up and Go.||0.74|-1.23|0.63
71046185|NCT02312713|141600649|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.72||||0.21|TWO_SIDED|95.0|-1.85|0.41|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Timed Up and Go.||0.41|-1.85|0.21
71046186|NCT02312713|141600650|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.05|TWO_SIDED|95.0|-1.59|0.02|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||0.02|-1.59|0.05
70926724|NCT05020249|141348392|SUPERIORITY||LS Mean Difference|-80.444|||<|0.001|TWO_SIDED|95.0|-102.509|-58.379|||ANCOVA|||||-58.379|-102.509|<0.001
70926725|NCT03628924|141348402|SUPERIORITY||Treatment difference|12.6|||=|0.166|TWO_SIDED|95.0|-4.6|29.8|||Cochran-Mantel-Haenszel|||||29.8|-4.6|= 0.166
70926726|NCT03628924|141348402|SUPERIORITY||Treatment difference|6.6|||=|0.459|TWO_SIDED|95.0|-10.3|23.6|||Cochran-Mantel-Haenszel|||||23.6|-10.3|= 0.459
70926727|NCT03959696|141348424|SUPERIORITY||Mean Difference (Net)|0.36||||0.011|TWO_SIDED|95.0|0.08|0.64||A priori threshold for statistical significance is .05|Regression, Linear|We used a linear regression model with Generalized Estimating Equations (GEE) techniques to account for the patients-within-physicians data structure|Mean difference is the Training + Notification arm minus the Notification only arm|The null hypothesis SDMP is equal in the two arms||.64|.08|.011
71046187|NCT02312713|141600650|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.05|TWO_SIDED|95.0|-1.82|0.02|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||0.02|-1.82|0.05
71046188|NCT02312713|141600650|SUPERIORITY||Mean Difference (Final Values)|-0.55||||0.19|TWO_SIDED|95.0|-1.37|0.27|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||0.27|-1.37|0.19
70926728|NCT03959696|141348425|SUPERIORITY||Mean Difference (Net)|1.77||||0.36|TWO_SIDED|95.0|-2.01|5.55||A priori threshold for statistical significance is .05|Regression, Linear|We used a linear regression model with Generalized Estimating Equations (GEE) techniques to account for the patients-within-physicians data structure||The null hypothesis is that the two arms have the same knowledge score||5.55|-2.01|0.36
70926729|NCT03959696|141348426|SUPERIORITY|We will have 81% power to detect a difference of 14% in rates (e.g. decrease from 61% to 47%).||||||0.47|||||||Regression, Logistic|||We will compare the percentages of patients who received their preferred screening in the 12 months after the visit across the two groups using logistic regression model with the GEE approach to adjust for clustering of patients within clinicians.||||0.47
70926730|NCT03959696|141348427|SUPERIORITY||Mean Difference (Final Values)|0.53||||0.19|TWO_SIDED||||||t-test, 2 sided|||||||0.19
70926731|NCT03959696|141348428|SUPERIORITY||Risk Difference (RD)|9.4||||0.032|TWO_SIDED|95.0|0.9|18.0|||Chi-squared|||Null hypothesis was equal screening rate in both arms||18.0|0.9|0.032
70926732|NCT03959696|141348429|SUPERIORITY||Risk Difference (RD)|1.5||||0.64|TWO_SIDED||||||Chi-squared|||||||0.64
70926733|NCT05337306|141348455|SUPERIORITY|ANCOVA controlling for study arm and baseline||||||0.049||||||a priori threshold .05; no adjustment for multiple comparisons|ANCOVA|covariates include arm and baseline level of outcome||Last Observation Carried Forward (LOCF) for those lost to follow up; null hypothesis group 1 follow-up outcome = group 2 follow-up outcome.||||.049
70926734|NCT05337306|141348456|SUPERIORITY|||||||0.04||||||a priori threshold .05; no adjustment for multiple comparisons|ANCOVA|Covariates include trial arm and baseline level of outcome.||LOCF for lost to follow-up||||.040
71103416|NCT00863304|141714817|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.25||0.067|TWO_SIDED|95.0|-0.94|0.03||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.03|-0.94|0.067
70926735|NCT05337306|141348457|SUPERIORITY|||||||0.22|||||||ANCOVA|covariates include trial arm and baseline level of outcome.||LOCF for dropout/lost to follow up||||.220
70926736|NCT04971681|141348476|SUPERIORITY||||||<|0.27|||||||t-test, 2 sided|||||||<0.27
70926737|NCT04971681|141348477|SUPERIORITY||||||<|0.1|||||||t-test, 2 sided|||||||<0.10
70926738|NCT00686335|141348478|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.9|STANDARD_DEVIATION|6.07|||TWO_SIDED|95.0|-13.5|-2.2||As this was an explorative study to collect data for a subsequent controlled study, no hypothesis testing was performed. All analyses were descriptive.|Other|As this was an explorative study, no hypothesis testing was performed. All analyses were descriptive.||As this was an explorative study to collect data for a subsequent controlled study, no hypothesis testing was performed. All analyses were descriptive.||-2.2|-13.5|
70926739|NCT06019559|141348522|SUPERIORITY|||||||0.0756||||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|MMRM model with gender, treatment, visit and treatment-by-visit interaction as fixed effect, and baseline body weight as a covariate.||||||0.0756
70926740|NCT06019559|141348522|SUPERIORITY|||||||0.0008||||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|(MMRM) model with gender, treatment, visit and treatment-by-visit interaction as fixed effect, and baseline body weight as a covariate.||For the primary endpoint of percentage change from baseline in body weight, a sample size of 150 participants (stratified by gender and randomized 1:1:1 into three treatment arms) provided \>95% power to detect a treatment difference of 4% weight reduction after 13 weeks of treatment with a 2-sided alpha of 0.05, assuming a standard deviation of 4% and 20% drop out.||||0.0008
71009886|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|-3.84|STANDARD_ERROR_OF_MEAN|4.91|||TWO_SIDED|95.0|-14.03|6.35|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||6.35|-14.03|
71009887|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|0.78|STANDARD_ERROR_OF_MEAN|4.62|||TWO_SIDED|95.0|-8.8|10.35|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||10.35|-8.80|
71009888|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|-7.13|STANDARD_ERROR_OF_MEAN|5.12|||TWO_SIDED|95.0|-17.79|3.53|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||3.53|-17.79|
71009889|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|1.66|STANDARD_ERROR_OF_MEAN|4.93|||TWO_SIDED|95.0|-8.59|11.91|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||11.91|-8.59|
71009890|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|-6.31|STANDARD_ERROR_OF_MEAN|4.74|||TWO_SIDED|95.0|-16.17|3.55|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||3.55|-16.17|
71103417|NCT00863304|141714817|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.25||0.002|TWO_SIDED|95.0|-1.26|-0.29||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.29|-1.26|0.002
71103418|NCT00863304|141714817|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.25||0.031|TWO_SIDED|95.0|-1.03|-0.05||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.05|-1.03|0.031
70926741|NCT06019559|141348523|SUPERIORITY|||||||0.8366||||||The threshold for significance was p = 0.05.|Regression, Logistic|||||||0.8366
70926742|NCT06019559|141348523|SUPERIORITY|||||||0.1848||||||The threshold for significance was p = 0.05.|Regression, Logistic|||||||0.1848
70926743|NCT06019559|141348524|SUPERIORITY|||||||0.0616||||||The threshold for significance was p = 0.05.|Mixed Models Analysis|||||||0.0616
71009891|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|-1.17|STANDARD_ERROR_OF_MEAN|4.54|||TWO_SIDED|95.0|-10.6|8.27|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||8.27|-10.60|
70926744|NCT06019559|141348524|SUPERIORITY|||||||0.0004||||||The threshold for significance was p = 0.05.|Mixed Models Analysis|||||||0.0004
70926745|NCT03858634|141348542|SUPERIORITY||Least squares (LS) mean difference|-3.3|STANDARD_ERROR_OF_MEAN|3.31||0.398|TWO_SIDED|80.0|-8.68|2.17||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||2.17|-8.68|0.3980
71046189|NCT02312713|141600650|SUPERIORITY||Mean Difference (Final Values)|-0.89||||0.06|TWO_SIDED|95.0|-1.83|0.05|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||0.05|-1.83|0.06
71046190|NCT02312713|141600650|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.23||||0.49|TWO_SIDED|95.0|-0.43|0.89|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||0.89|-0.43|0.49
71046191|NCT02312713|141600650|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED|95.0|-0.77|0.78|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||0.78|-0.77|0.99
71046192|NCT02312713|141600651|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|1.57||||0.36|TWO_SIDED|95.0|-1.77|4.92|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for KOOS Pain.||4.92|-1.77|0.36
71046193|NCT02312713|141600651|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|2.51||||0.17|TWO_SIDED|95.0|-1.11|6.14|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months for KOOS Pain.||6.14|-1.11|0.17
71046194|NCT02312713|141600651|SUPERIORITY||Mean Difference (Final Values)|3.94||||0.06|TWO_SIDED|95.0|-0.19|8.06|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for KOOS Pain.||8.06|-0.19|0.06
71046195|NCT02312713|141600651|SUPERIORITY||Mean Difference (Final Values)|3.36||||0.14|TWO_SIDED|95.0|-1.08|7.79|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for KOOS Pain.||7.79|-1.08|0.14
71046196|NCT02312713|141600651|SUPERIORITY||Mean Difference (Final Values)|2.37||||0.25|TWO_SIDED|95.0|-1.67|6.4|||Mixed Models Analysis|||This is the comparison between Standard Physical Therapy and Wait List Control at 4 months for KOOS Pain.||6.4|-1.67|0.25
70926746|NCT03858634|141348542|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|1.23||0.6653|TWO_SIDED|80.0|-2.17|1.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||1.09|-2.17|0.6653
70926747|NCT03858634|141348542|SUPERIORITY||LS mean difference|-7.6|STANDARD_ERROR_OF_MEAN|2.14||0.0711|TWO_SIDED|80.0|-11.63|-3.56||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||-3.56|-11.63|0.0711
70926748|NCT03858634|141348542|SUPERIORITY||LS mean difference|-3.1|STANDARD_ERROR_OF_MEAN|1.2||0.0186|TWO_SIDED|80.0|-4.7|-1.51||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||-1.51|-4.70|0.0186
71046197|NCT02312713|141600651|SUPERIORITY||Mean Difference (Final Values)|0.85||||0.7|TWO_SIDED|95.0|-3.48|5.18|||Mixed Models Analysis|||This is the comparison between Standard Physical Therapy and Wait List Control at 12 months for KOOS Pain.||5.18|-3.48|0.70
71046198|NCT02312713|141600651|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-1.32||||0.4|TWO_SIDED|95.0|-4.43|1.79|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for KOOS ADL.||1.79|-4.43|0.40
70926749|NCT03858634|141348544|SUPERIORITY||LS mean difference|-7.3|STANDARD_ERROR_OF_MEAN|14.76||0.6533|TWO_SIDED|80.0|-31.52|16.84||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||16.84|-31.52|0.6533
70926750|NCT03858634|141348544|SUPERIORITY||LS mean difference|-1.2|STANDARD_ERROR_OF_MEAN|10.51||0.9077|TWO_SIDED|80.0|-15.16|12.69||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||12.69|-15.16|0.9077
71046199|NCT02312713|141600651|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.33||||0.84|TWO_SIDED|95.0|-2.93|3.59|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for KOOS ADL.||3.59|-2.93|0.84
71046200|NCT02312713|141600651|SUPERIORITY||Mean Difference (Final Values)|2.11||||0.28|TWO_SIDED|95.0|-1.73|5.94|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 month for KOOS ADL.||5.94|-1.73|0.28
71046201|NCT02312713|141600651|SUPERIORITY||Mean Difference (Final Values)|2.79||||0.17|TWO_SIDED|95.0|-1.2|6.77|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 month for KOOS ADL.||6.77|-1.2|0.17
71046202|NCT02312713|141600651|SUPERIORITY||Mean Difference (Final Values)|3.43||||0.07|TWO_SIDED|95.0|-0.32|7.18|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for KOOS ADL.||7.18|-0.32|0.07
71046203|NCT02312713|141600651|SUPERIORITY||Mean Difference (Final Values)|2.45||||0.22|TWO_SIDED|95.0|-1.44|6.34|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for KOOS ADL.||6.34|-1.44|0.22
70926751|NCT03858634|141348544|SUPERIORITY||LS mean difference|-61.2|STANDARD_ERROR_OF_MEAN|33.18||0.2065|TWO_SIDED|80.0|-123.73|1.39||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||1.39|-123.73|0.2065
71103419|NCT00863304|141714818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.5|-0.18||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.18|-0.50|<0.001
71103420|NCT00863304|141714818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.48|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-0.48|<0.001
71103421|NCT00863304|141714818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.08||0.078|TWO_SIDED|95.0|-0.3|0.02||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.02|-0.30|0.078
71103422|NCT00863304|141714818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.08||0.019|TWO_SIDED|95.0|-0.35|-0.03||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.03|-0.35|0.019
71103423|NCT00863304|141714818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.029|TWO_SIDED|95.0|-0.34|-0.02||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.02|-0.34|0.029
71103424|NCT00863304|141714819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.23||0.029|TWO_SIDED|95.0|-0.94|-0.05||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.05|-0.94|0.029
71103425|NCT00863304|141714819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.23||0.214|TWO_SIDED|95.0|-0.73|0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.16|-0.73|0.214
71103426|NCT00863304|141714819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.21|-0.32||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.32|-1.21|<0.001
71103427|NCT00863304|141714819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.23||0.234|TWO_SIDED|95.0|-0.18|0.72||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.72|-0.18|0.234
71103428|NCT00863304|141714819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.23||0.034|TWO_SIDED|95.0|0.04|0.93||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.93|0.04|0.034
71103429|NCT00863304|141714819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.16|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.63|-0.7||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.70|-1.63|<0.001
71103430|NCT00863304|141714819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.42|-0.49||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.49|-1.42|<0.001
71103431|NCT00863304|141714819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.24||0.007|TWO_SIDED|95.0|-1.11|-0.18||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.18|-1.11|0.007
71103432|NCT00863304|141714819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.24||0.029|TWO_SIDED|95.0|-0.99|-0.05||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.05|-0.99|0.029
71103433|NCT00863304|141714819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.24||0.193|TWO_SIDED|95.0|-0.78|0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.16|-0.78|0.193
71103434|NCT00863304|141714819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.68|-0.73||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.73|-1.68|<0.001
70926752|NCT03858634|141348544|SUPERIORITY||LS mean difference|-5.3|STANDARD_ERROR_OF_MEAN|3.19||0.1133|TWO_SIDED|80.0|-9.56|-1.07||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||-1.07|-9.56|0.1133
71103435|NCT00863304|141714819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.24||0.001|TWO_SIDED|95.0|-1.28|-0.32||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.32|-1.28|0.001
71103436|NCT00863304|141714819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.24||0.011|TWO_SIDED|95.0|-1.1|-0.14||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.14|-1.10|0.011
70926753|NCT03858634|141348544|SUPERIORITY||LS mean difference|-16.7|STANDARD_ERROR_OF_MEAN|21.76||0.4997|TWO_SIDED|80.0|-52.29|18.98||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||18.98|-52.29|0.4997
70926754|NCT03858634|141348544|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|11.85||0.9919|TWO_SIDED|80.0|-15.83|15.59||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||15.59|-15.83|0.9919
70926755|NCT03858634|141348544|SUPERIORITY||LS mean difference|-89.2|STANDARD_ERROR_OF_MEAN|28.56||0.0891|TWO_SIDED|80.0|-143.03|-35.31||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||-35.31|-143.03|0.0891
70926756|NCT03858634|141348544|SUPERIORITY||LS mean difference|-9.4|STANDARD_ERROR_OF_MEAN|5.47||0.1029|TWO_SIDED|80.0|-16.67|-2.12||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||-2.12|-16.67|0.1029
70926757|NCT03858634|141348544|SUPERIORITY||LS mean difference|-21.9|STANDARD_ERROR_OF_MEAN|32.93||0.5538|TWO_SIDED|80.0|-75.82|32.05||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||32.05|-75.82|0.5538
70926758|NCT03858634|141348544|SUPERIORITY||LS mean difference|-11.9|STANDARD_ERROR_OF_MEAN|11.78||0.3252|TWO_SIDED|80.0|-27.51|3.73||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||3.73|-27.51|0.3252
70926759|NCT03858634|141348544|SUPERIORITY||LS mean difference|-93.8|STANDARD_ERROR_OF_MEAN|34.1||0.1106|TWO_SIDED|80.0|-158.11|-29.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||-29.52|-158.11|0.1106
70926760|NCT03858634|141348544|SUPERIORITY||LS mean difference|-19.9|STANDARD_ERROR_OF_MEAN|7.17||0.0123|TWO_SIDED|80.0|-29.48|-10.4||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||-10.40|-29.48|0.0123
70926761|NCT03858634|141348544|SUPERIORITY||LS mean difference|-28.9|STANDARD_ERROR_OF_MEAN|35.86||0.4791|TWO_SIDED|80.0|-87.63|29.81||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||29.81|-87.63|0.4791
70926762|NCT03858634|141348544|SUPERIORITY||LS mean difference|-5.5|STANDARD_ERROR_OF_MEAN|12.66||0.6684|TWO_SIDED|80.0|-22.28|11.27||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||11.27|-22.28|0.6684
70926763|NCT03858634|141348544|SUPERIORITY||LS mean difference|-79.7|STANDARD_ERROR_OF_MEAN|26.28||0.0937|TWO_SIDED|80.0|-129.22|-30.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-30.13|-129.22|0.0937
70926764|NCT03858634|141348544|SUPERIORITY||LS mean difference|-27.2|STANDARD_ERROR_OF_MEAN|9.75||0.012|TWO_SIDED|80.0|-40.21|-14.27||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-14.27|-40.21|0.0120
70926765|NCT03858634|141348544|SUPERIORITY||LS mean difference|-32.7|STANDARD_ERROR_OF_MEAN|41.95||0.4927|TWO_SIDED|80.0|-101.39|36.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||36.02|-101.39|0.4927
70926766|NCT03858634|141348544|SUPERIORITY||LS mean difference|-10.9|STANDARD_ERROR_OF_MEAN|13.9||0.4409|TWO_SIDED|80.0|-29.35|7.49||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||7.49|-29.35|0.4409
70926767|NCT03858634|141348544|SUPERIORITY||LS mean difference|-90.7|STANDARD_ERROR_OF_MEAN|34.58||0.1197|TWO_SIDED|80.0|-155.96|-25.54||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||-25.54|-155.96|0.1197
70926768|NCT03858634|141348544|SUPERIORITY||LS mean difference|-35.3|STANDARD_ERROR_OF_MEAN|12.31||0.0102|TWO_SIDED|80.0|-51.68|-18.92||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANOVA|||Change at Week 5||-18.92|-51.68|0.0102
70926769|NCT03858634|141348544|SUPERIORITY||LS mean difference|-33.5|STANDARD_ERROR_OF_MEAN|38.77||0.4515|TWO_SIDED|80.0|-96.97|30.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||30.02|-96.97|0.4515
70926770|NCT03858634|141348544|SUPERIORITY||LS mean difference|-4.5|STANDARD_ERROR_OF_MEAN|14.56||0.7623|TWO_SIDED|80.0|-23.76|14.83||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||14.83|-23.76|0.7623
70926771|NCT03858634|141348544|SUPERIORITY||LS mean difference|-88.5|STANDARD_ERROR_OF_MEAN|34.57||0.1247|TWO_SIDED|80.0|-153.65|-23.29||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-23.29|-153.65|0.1247
70926772|NCT03858634|141348544|SUPERIORITY||LS mean difference|-37.7|STANDARD_ERROR_OF_MEAN|11.91||0.0053|TWO_SIDED|80.0|-53.59|-21.9||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-21.90|-53.59|0.0053
70926773|NCT03858634|141348544|SUPERIORITY||LS mean difference|-17.2|STANDARD_ERROR_OF_MEAN|43.23||0.7177|TWO_SIDED|80.0|-87.97|53.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||53.62|-87.97|0.7177
70926774|NCT03858634|141348544|SUPERIORITY||LS mean difference|-6.2|STANDARD_ERROR_OF_MEAN|14.35||0.6682|TWO_SIDED|80.0|-25.26|12.78||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||12.78|-25.26|0.6682
70926775|NCT03858634|141348544|SUPERIORITY||LS mean difference|-95.2|STANDARD_ERROR_OF_MEAN|29.16||0.0823|TWO_SIDED|80.0|-150.21|-40.24||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-40.24|-150.21|0.0823
70926776|NCT03858634|141348544|SUPERIORITY||LS mean difference|-38.1|STANDARD_ERROR_OF_MEAN|12.95||0.0087|TWO_SIDED|80.0|-55.38|-20.92||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-20.92|-55.38|0.0087
70926777|NCT03858634|141348544|SUPERIORITY||LS mean difference|-31.7|STANDARD_ERROR_OF_MEAN|38.73||0.4734|TWO_SIDED|80.0|-95.11|31.76||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||31.76|-95.11|0.4734
70926778|NCT03858634|141348544|SUPERIORITY||LS mean difference|-3.6|STANDARD_ERROR_OF_MEAN|14.91||0.813|TWO_SIDED|80.0|-23.33|16.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||16.18|-23.33|0.8130
70926779|NCT03858634|141348544|SUPERIORITY||LS mean difference|-92.0|STANDARD_ERROR_OF_MEAN|31.1||0.0979|TWO_SIDED|80.0|-150.6|-33.32||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-33.32|-150.60|0.0979
70926780|NCT03858634|141348544|SUPERIORITY||LS mean difference|-37.5|STANDARD_ERROR_OF_MEAN|13.48||0.0122|TWO_SIDED|80.0|-55.48|-19.61||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-19.61|-55.48|0.0122
70926781|NCT03858634|141348544|SUPERIORITY||LS mean difference|-32.1|STANDARD_ERROR_OF_MEAN|35.35||0.431|TWO_SIDED|80.0|-89.98|25.81||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||25.81|-89.98|0.4310
70926782|NCT03858634|141348544|SUPERIORITY||LS mean difference|-7.1|STANDARD_ERROR_OF_MEAN|15.22||0.6452|TWO_SIDED|80.0|-27.38|13.12||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||13.12|-27.38|0.6452
70926783|NCT03858634|141348544|SUPERIORITY||LS mean difference|-89.2|STANDARD_ERROR_OF_MEAN|37.02||0.1375|TWO_SIDED|80.0|-159.04|-19.44||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||-19.44|-159.04|0.1375
70926784|NCT03858634|141348544|SUPERIORITY||LS mean difference|-39.6|STANDARD_ERROR_OF_MEAN|14.59||0.0143|TWO_SIDED|80.0|-58.97|-20.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||-20.15|-58.97|0.0143
70926785|NCT03858634|141348544|SUPERIORITY||LS mean difference|-22.1|STANDARD_ERROR_OF_MEAN|36.4||0.5867|TWO_SIDED|80.0|-81.7|37.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||37.52|-81.70|0.5867
70926786|NCT03858634|141348544|SUPERIORITY||LS mean difference|6.1|STANDARD_ERROR_OF_MEAN|14.38||0.6745|TWO_SIDED|80.0|-12.99|25.27||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||25.27|-12.99|0.6745
71046204|NCT02312713|141600651|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.21||||0.92|TWO_SIDED|95.0|-4.47|4.06|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for KOOS Sport/Rec.||4.06|-4.47|.92
71046205|NCT02312713|141600651|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.55||||0.82|TWO_SIDED|95.0|-4.15|5.24|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for KOOS Sport/Rec.||5.24|-4.15|.82
70926787|NCT03858634|141348544|SUPERIORITY||LS mean difference|-85.6|STANDARD_ERROR_OF_MEAN|29.99||0.1039|TWO_SIDED|80.0|-142.18|-29.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-29.09|-142.18|0.1039
70926788|NCT03858634|141348544|SUPERIORITY||LS mean difference|-42.5|STANDARD_ERROR_OF_MEAN|15.12||0.0116|TWO_SIDED|80.0|-62.6|-22.36||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-22.36|-62.60|0.0116
70926789|NCT03858634|141348544|SUPERIORITY||LS mean difference|-23.1|STANDARD_ERROR_OF_MEAN|37.49||0.5807|TWO_SIDED|80.0|-84.55|38.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||38.26|-84.55|0.5807
70926790|NCT03858634|141348544|SUPERIORITY||LS mean difference|8.6|STANDARD_ERROR_OF_MEAN|15.16||0.5765|TWO_SIDED|80.0|-11.55|28.8||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||28.80|-11.55|0.5765
70926791|NCT03858634|141348544|SUPERIORITY||LS mean difference|-86.2|STANDARD_ERROR_OF_MEAN|28.36||0.0933|TWO_SIDED|80.0|-139.7|-32.75||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||-32.75|-139.70|0.0933
70926792|NCT03858634|141348544|SUPERIORITY||LS mean difference|-39.3||||0.0173|TWO_SIDED|80.0|-59.29|-19.37||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||-19.37|-59.29|0.0173
70926793|NCT03858634|141348544|SUPERIORITY||LS mean difference|-27.2|STANDARD_ERROR_OF_MEAN|38.36||0.5293|TWO_SIDED|80.0|-90.04|35.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||35.62|-90.04|0.5293
71046206|NCT02312713|141600651|SUPERIORITY||Mean Difference (Final Values)|3.71||||0.17|TWO_SIDED|95.0|-1.59|9.0|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for KOOS Sport/Rec.||9|-1.59|0.17
70926794|NCT03858634|141348544|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|15.12||0.9676|TWO_SIDED|80.0|-20.73|19.49||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||19.49|-20.73|0.9676
71046207|NCT02312713|141600651|SUPERIORITY||Mean Difference (Final Values)|6.01||||0.04|TWO_SIDED|95.0|0.29|11.74|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for KOOS Sport/Rec.||11.74|0.29|0.04
71046208|NCT02312713|141600651|SUPERIORITY||Mean Difference (Final Values)|3.91||||0.14|TWO_SIDED|95.0|-1.28|9.1|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for KOOS Sport/Rec.||9.1|-1.28|0.14
70926795|NCT03858634|141348544|SUPERIORITY||LS mean difference|-86.2|STANDARD_ERROR_OF_MEAN|23.38||0.0663|TWO_SIDED|80.0|-130.27|-42.11||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-42.11|-130.27|0.0663
70926796|NCT03858634|141348544|SUPERIORITY||LS mean difference|-37.4|STANDARD_ERROR_OF_MEAN|15.33||0.0252|TWO_SIDED|80.0|-57.81|-17.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-17.02|-57.81|0.0252
70926797|NCT03858634|141348544|SUPERIORITY||LS mean difference|-19.6|STANDARD_ERROR_OF_MEAN|40.81||0.6637|TWO_SIDED|80.0|-86.45|47.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||47.22|-86.45|0.6637
71009892|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|-7.01|STANDARD_ERROR_OF_MEAN|5.83|||TWO_SIDED|95.0|-19.13|5.11|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||5.11|-19.13|
71009893|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|-4.11|STANDARD_ERROR_OF_MEAN|5.5|||TWO_SIDED|95.0|-15.55|7.34|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||7.34|-15.55|
71009894|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|1.77|STANDARD_ERROR_OF_MEAN|5.48|||TWO_SIDED|95.0|-9.63|13.17|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||13.17|-9.63|
71009895|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|-3.47|STANDARD_ERROR_OF_MEAN|5.18|||TWO_SIDED|95.0|-14.25|7.31|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||7.31|-14.25|
71009896|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|-1.73|STANDARD_ERROR_OF_MEAN|4.57|||TWO_SIDED|95.0|-11.24|7.77|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||7.77|-11.24|
71009897|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|-5.55|STANDARD_ERROR_OF_MEAN|4.46|||TWO_SIDED|95.0|-14.83|3.73|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||3.73|-14.83|
70926798|NCT03858634|141348544|SUPERIORITY||LS mean difference|-1.6|STANDARD_DEVIATION|15.35||0.9173|TWO_SIDED|80.0|-22.04|18.81||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||18.81|-22.04|0.9173
71009898|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|1.98|STANDARD_ERROR_OF_MEAN|5.21|||TWO_SIDED|95.0|-8.85|12.81|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||12.81|-8.85|
71009899|NCT03091920|141526968|OTHER|No statistical testing was performed.|Least squares mean difference|1.07|STANDARD_ERROR_OF_MEAN|4.69|||TWO_SIDED|95.0|-8.68|10.82|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||10.82|-8.68|
71009900|NCT03091920|141526969|OTHER|No statistical testing was performed.|Least squares mean difference|-2.12|STANDARD_ERROR_OF_MEAN|2.06|||TWO_SIDED|95.0|-6.38|2.15|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||2.15|-6.38|
71103437|NCT00863304|141714819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.24||0.017|TWO_SIDED|95.0|-1.06|-0.1||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.10|-1.06|0.017
70926799|NCT03858634|141348544|SUPERIORITY||LS mean difference|-96.2|STANDARD_ERROR_OF_MEAN|26.55||0.0685|TWO_SIDED|80.0|-146.23|-46.1||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||-46.10|-146.23|0.0685
71009901|NCT03091920|141526969|OTHER|No statistical testing was performed.|Least squares mean difference|-2.39|STANDARD_ERROR_OF_MEAN|2.02|||TWO_SIDED|95.0|-6.59|1.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||1.80|-6.59|
71009902|NCT03091920|141526969|OTHER|No statistical testing was performed.|Least squares mean difference|-2.26|STANDARD_ERROR_OF_MEAN|1.86|||TWO_SIDED|95.0|-6.11|1.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1||1.60|-6.11|
71009903|NCT03091920|141526969|OTHER|No statistical testing was performed.|Least squares mean difference|-3.39|STANDARD_ERROR_OF_MEAN|2.34|||TWO_SIDED|95.0|-8.25|1.47|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||1.47|-8.25|
71009904|NCT03091920|141526969|OTHER|No statistical testing was performed.|Least squares mean difference|-1.61|STANDARD_ERROR_OF_MEAN|2.31|||TWO_SIDED|95.0|-6.4|3.18|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||3.18|-6.40|
71009905|NCT03091920|141526969|OTHER|No statistical testing was performed.|Least squares mean difference|-2.5|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|95.0|-6.9|1.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 7||1.90|-6.90|
71009906|NCT03091920|141526969|OTHER|No statistical testing was performed.|Least squares mean difference|-4.96|STANDARD_ERROR_OF_MEAN|3.01|||TWO_SIDED|95.0|-11.22|1.31|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||1.31|-11.22|
71009907|NCT03091920|141526969|OTHER|No statistical testing was performed.|Least squares mean difference|-4.5|STANDARD_ERROR_OF_MEAN|2.84|||TWO_SIDED|95.0|-10.41|1.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||1.40|-10.41|
70926800|NCT03858634|141348544|SUPERIORITY||LS mean difference|-39.7|STANDARD_ERROR_OF_MEAN|15.96||0.023|TWO_SIDED|80.0|-60.91|-18.44||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||-18.44|-60.91|0.0230
70926801|NCT03858634|141348544|SUPERIORITY||LS mean difference|-19.1|STANDARD_ERROR_OF_MEAN|37.62||0.6471|TWO_SIDED|80.0|-80.69|42.54||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||42.54|-80.69|0.6471
70926802|NCT03858634|141348544|SUPERIORITY||LS mean difference|-3.9|STANDARD_ERROR_OF_MEAN|15.52||0.8044|TWO_SIDED|80.0|-24.56|16.75||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||16.75|-24.56|0.8044
70926803|NCT03858634|141348544|SUPERIORITY||LS mean difference|-99.5|STANDARD_ERROR_OF_MEAN|28.71||0.0741|TWO_SIDED|80.0|-153.63|-45.37||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-45.37|-153.63|0.0741
70926804|NCT03858634|141348544|SUPERIORITY||LS mean difference|-39.9|STANDARD_ERROR_OF_MEAN|15.89||0.0219|TWO_SIDED|80.0|-61.0|-18.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-18.72|-61.00|0.0219
70926805|NCT03858634|141348544|SUPERIORITY||LS mean difference|-25.4|STANDARD_ERROR_OF_MEAN|37.15||0.5436|TWO_SIDED|80.0|-86.21|35.46||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||35.46|-86.21|0.5436
70926806|NCT03858634|141348544|SUPERIORITY||LS mean difference|-1.7|STANDARD_ERROR_OF_MEAN|16.13||0.9149|TWO_SIDED|80.0|-23.2|19.71||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||19.71|-23.20|0.9149
70926807|NCT03858634|141348544|SUPERIORITY||LS mean difference|-94.8|STANDARD_ERROR_OF_MEAN|25.34||0.0646|TWO_SIDED|80.0|-142.63|-47.05||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||-47.05|-142.63|0.0646
70926808|NCT03858634|141348544|SUPERIORITY||LS mean difference|-34.2|STANDARD_ERROR_OF_MEAN|17.09||0.0611|TWO_SIDED|80.0|-56.89|-11.41||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||-11.41|-56.89|0.0611
70926809|NCT03858634|141348544|SUPERIORITY||LS mean difference|-22.0|STANDARD_ERROR_OF_MEAN|38.28||0.606|TWO_SIDED|80.0|-84.68|40.71||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||40.71|-84.68|0.6060
70926810|NCT03858634|141348544|SUPERIORITY||LS mean difference|-6.9|STANDARD_ERROR_OF_MEAN|16.61||0.6823|TWO_SIDED|80.0|-29.0|15.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||15.18|-29.00|0.6823
70926811|NCT03858634|141348544|SUPERIORITY||LS mean difference|-99.7|STANDARD_ERROR_OF_MEAN|24.56||0.0556|TWO_SIDED|80.0|-146.02|-53.41||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-53.41|-146.02|0.0556
70926812|NCT03858634|141348544|SUPERIORITY||LS mean difference|-33.4|STANDARD_ERROR_OF_MEAN|16.99||0.0652|TWO_SIDED|80.0|-55.98|-10.76||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-10.76|-55.98|0.0652
70926813|NCT03858634|141348544|SUPERIORITY||LS mean difference|-26.3|STANDARD_ERROR_OF_MEAN|41.45||0.5714|TWO_SIDED|80.0|-94.14|41.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||41.62|-94.14|0.5714
70926814|NCT03858634|141348544|OTHER||LS mean difference|-10.5|STANDARD_ERROR_OF_MEAN|16.82||0.5386|TWO_SIDED|80.0|-32.93|11.83||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||11.83|-32.93|0.5386
70926815|NCT03858634|141348544|SUPERIORITY||LS mean difference|-99.0|STANDARD_ERROR_OF_MEAN|21.41||0.0438|TWO_SIDED|80.0|-139.35|-58.6||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||-58.60|-139.35|0.0438
70926816|NCT03858634|141348544|OTHER||LS mean difference|-27.2|STANDARD_ERROR_OF_MEAN|19.66||0.1829|TWO_SIDED|80.0|-53.38|-1.08||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||-1.08|-53.38|0.1829
70926817|NCT03858634|141348544|SUPERIORITY||LS mean difference|-25.6|STANDARD_ERROR_OF_MEAN|37.59||0.5443|TWO_SIDED|80.0|-87.2|35.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||35.94|-87.20|0.5443
70926818|NCT03858634|141348544|SUPERIORITY||LS mean difference|-7.9|STANDARD_ERROR_OF_MEAN|18.43||0.6748|TWO_SIDED|80.0|-32.39|16.66||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||16.66|-32.39|0.6748
70926819|NCT03858634|141348544|SUPERIORITY||LS mean difference|-96.2|STANDARD_ERROR_OF_MEAN|16.97||0.0297|TWO_SIDED|80.0|-128.19|-64.19||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-64.19|-128.19|0.0297
70926820|NCT03858634|141348544|SUPERIORITY||LS mean difference|-27.0|STANDARD_ERROR_OF_MEAN|19.8||0.1899|TWO_SIDED|80.0|-53.33|-0.63||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-0.63|-53.33|0.1899
70926821|NCT03858634|141348546|SUPERIORITY||LS mean difference|-15.3|STANDARD_ERROR_OF_MEAN|24.47||0.5763|TWO_SIDED|80.0|-55.37|24.78||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||24.78|-55.37|0.5763
70926822|NCT03858634|141348546|SUPERIORITY||LS mean difference|9.6|STANDARD_ERROR_OF_MEAN|14.66||0.5214|TWO_SIDED|80.0|-9.86|29.01||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||29.01|-9.86|0.5214
70926823|NCT03858634|141348546|SUPERIORITY||LS mean difference|-167.0|STANDARD_ERROR_OF_MEAN|105.28||0.2536|TWO_SIDED|80.0|-365.51|31.54||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||31.54|-365.51|0.2536
70926824|NCT03858634|141348546|SUPERIORITY||LS mean difference|-10.8|STANDARD_ERROR_OF_MEAN|5.55||0.067|TWO_SIDED|80.0|-18.2|-3.44||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||-3.44|-18.20|0.0670
70926825|NCT03858634|141348546|SUPERIORITY||LS mean difference|-33.1|STANDARD_ERROR_OF_MEAN|34.98||0.4133|TWO_SIDED|80.0|-90.43|24.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||24.15|-90.43|0.4133
70926826|NCT03858634|141348546|SUPERIORITY||LS mean difference|-1.4|STANDARD_ERROR_OF_MEAN|15.44||0.9305|TWO_SIDED|80.0|-21.83|19.11|||ANCOVA|||Change at Week 2||19.11|-21.83|0.9305
70926827|NCT03858634|141348546|SUPERIORITY||LS mean difference|-160.9|STANDARD_ERROR_OF_MEAN|132.98||0.3499|TWO_SIDED|80.0|-411.65|89.86||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||89.86|-411.65|0.3499
70926828|NCT03858634|141348546|SUPERIORITY||LS mean difference|-14.0|STANDARD_ERROR_OF_MEAN|9.55||0.1588|TWO_SIDED|80.0|-26.74|-1.33||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||-1.33|-26.74|0.1588
70926829|NCT03858634|141348546|SUPERIORITY||LS mean difference|-40.6|STANDARD_ERROR_OF_MEAN|35.19||0.3319|TWO_SIDED|80.0|-98.26|17.0||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||17.00|-98.26|0.3319
70926830|NCT03858634|141348546|SUPERIORITY||LS mean difference|7.1|STANDARD_ERROR_OF_MEAN|19.39||0.7179|TWO_SIDED|80.0|-18.59|32.8||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||32.80|-18.59|0.7179
70926831|NCT03858634|141348546|SUPERIORITY||LS mean difference|-193.8|STANDARD_ERROR_OF_MEAN|112.17||0.2261|TWO_SIDED|80.0|-405.34|17.67||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||17.67|-405.34|0.2261
70926832|NCT03858634|141348546|SUPERIORITY||LS mean difference|-30.3|STANDARD_ERROR_OF_MEAN|10.88||0.0123|TWO_SIDED|80.0|-44.75|-15.8||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||-15.80|-44.75|0.0123
70926833|NCT03858634|141348546|SUPERIORITY||LS mean difference|-54.0|STANDARD_ERROR_OF_MEAN|35.45||0.2253|TWO_SIDED|80.0|-112.02|4.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||4.09|-112.02|0.2253
70926834|NCT03858634|141348546|SUPERIORITY||LS mean difference|6.3|STANDARD_ERROR_OF_MEAN|16.9||0.7149|TWO_SIDED|80.0|-16.14|28.66||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||28.66|-16.14|0.7149
70926835|NCT03858634|141348546|SUPERIORITY||LS mean difference|-168.4|STANDARD_ERROR_OF_MEAN|109.12||0.2627|TWO_SIDED|80.0|-374.16|37.36||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||37.36|-374.16|0.2627
70926836|NCT03858634|141348546|SUPERIORITY||LS mean difference|-36.7|STANDARD_ERROR_OF_MEAN|11.38||0.0047|TWO_SIDED|80.0|-51.87|-21.6||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-21.60|-51.87|0.0047
70926837|NCT03858634|141348546|SUPERIORITY||LS mean difference|-66.1|STANDARD_ERROR_OF_MEAN|38.01||0.1803|TWO_SIDED|80.0|-128.37|-3.88||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||-3.88|-128.37|0.1803
70926838|NCT03858634|141348546|SUPERIORITY||LS mean difference|6.4|STANDARD_ERROR_OF_MEAN|17.34||0.7174|TWO_SIDED|80.0|-16.62|29.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||29.35|-16.62|0.7174
70926839|NCT03858634|141348546|SUPERIORITY||LS mean difference|-163.4|STANDARD_ERROR_OF_MEAN|103.47||0.2551|TWO_SIDED|80.0|-358.51|31.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||31.72|-358.51|0.2551
71046209|NCT02312713|141600651|SUPERIORITY||Mean Difference (Final Values)|5.47||||0.05|TWO_SIDED|95.0|-0.1|11.03|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for KOOS Sport/Rec.||11.03|-0.1|0.05
71046210|NCT02312713|141600651|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.33||||0.86|TWO_SIDED|95.0|-3.29|3.96|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for KOOS QOL.||3.96|-3.29|.86
71046211|NCT02312713|141600651|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|2.59||||0.15|TWO_SIDED|95.0|-0.96|6.13|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for KOOS QOL.||6.13|-0.96|0.15
71046212|NCT02312713|141600651|SUPERIORITY||Mean Difference (Final Values)|3.63||||0.11|TWO_SIDED|95.0|-0.85|8.11|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for KOOS QOL.||8.11|-0.85|0.11
71046213|NCT02312713|141600651|SUPERIORITY||Mean Difference (Final Values)|7.74||||0|TWO_SIDED|95.0|3.39|12.08|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for KOOS QOL.||12.08|3.39|0
71046214|NCT02312713|141600651|SUPERIORITY||Mean Difference (Final Values)|3.29||||0.14|TWO_SIDED|95.0|-1.08|7.67|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for KOOS QOL.||7.67|-1.08|0.14
70926840|NCT03858634|141348546|SUPERIORITY||LS mean difference|-33.5|STANDARD_ERROR_OF_MEAN|11.36||0.0086|TWO_SIDED|80.0|-48.58|-18.36||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||-18.36|-48.58|0.0086
70926841|NCT03858634|141348546|SUPERIORITY||LS mean difference|-56.0|STANDARD_ERROR_OF_MEAN|40.16||0.2576|TWO_SIDED|80.0|-121.78|9.78||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||9.78|-121.78|0.2576
70926842|NCT03858634|141348546|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|18.09||0.9722|TWO_SIDED|80.0|-24.62|23.34||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||23.34|-24.62|0.9722
70926843|NCT03858634|141348546|SUPERIORITY||LS mean difference|-177.4|STANDARD_ERROR_OF_MEAN|95.72||0.2051|TWO_SIDED|80.0|-357.85|3.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||3.13|-357.85|0.2051
70926844|NCT03858634|141348546|SUPERIORITY||LS mean difference|-42.0|STANDARD_ERROR_OF_MEAN|11.99||0.0025|TWO_SIDED|80.0|-57.98|-26.08||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-26.08|-57.98|0.0025
70926845|NCT03858634|141348546|SUPERIORITY||LS mean difference|-65.8|STANDARD_ERROR_OF_MEAN|33.78||0.1465|TWO_SIDED|80.0|-121.14|-10.5||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-10.50|-121.14|0.1465
70926846|NCT03858634|141348546|SUPERIORITY||LS mean difference|5.1|STANDARD_ERROR_OF_MEAN|17.54||0.7734|TWO_SIDED|80.0|-18.13|28.37||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||28.37|-18.13|0.7734
70926847|NCT03858634|141348546|SUPERIORITY||LS mean difference|-175.5|STANDARD_ERROR_OF_MEAN|87.45||0.1826|TWO_SIDED|80.0|-340.37|-10.56||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-10.56|-340.37|0.1826
70926848|NCT03858634|141348546|SUPERIORITY||LS mean difference|-39.2|STANDARD_ERROR_OF_MEAN|13.71||0.0105|TWO_SIDED|80.0|-57.4|-20.93||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-20.93|-57.40|0.0105
70926849|NCT03858634|141348546|SUPERIORITY||LS mean difference|-53.7|STANDARD_ERROR_OF_MEAN|40.17||0.2737|TWO_SIDED|80.0|-119.49|12.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||12.09|-119.49|0.2737
71046215|NCT02312713|141600651|SUPERIORITY||Mean Difference (Final Values)|5.15||||0.02|TWO_SIDED|95.0|0.92|9.37|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for KOOS QOL.||9.37|0.92|0.02
71046216|NCT02312713|141600652|SUPERIORITY||Mean Difference (Final Values)|-2.58||||0.02|TWO_SIDED|95.0|-4.67|-0.5|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||-0.5|-4.67|0.02
70926850|NCT03858634|141348546|SUPERIORITY||LS mean difference|3.0|STANDARD_ERROR_OF_MEAN|17.77||0.8692|TWO_SIDED|80.0|-20.59|26.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||26.52|-20.59|0.8692
70926851|NCT03858634|141348546|SUPERIORITY||LS mean difference|-163.0|STANDARD_ERROR_OF_MEAN|89.64||0.2106|TWO_SIDED|80.0|-332.06|5.99||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||5.99|-332.06|0.2106
70926852|NCT03858634|141348546|SUPERIORITY||LS mean difference|-45.7|STANDARD_ERROR_OF_MEAN|14.67||0.006|TWO_SIDED|80.0|-65.19|-26.14||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-26.14|-65.19|0.0060
70926853|NCT03858634|141348546|SUPERIORITY||LS mean difference|-62.3|STANDARD_ERROR_OF_MEAN|36.12||0.1831|TWO_SIDED|80.0|-121.44|-3.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-3.13|-121.44|0.1831
70926854|NCT03858634|141348546|SUPERIORITY||LS mean difference|21.5|STANDARD_ERROR_OF_MEAN|16.39||0.2061|TWO_SIDED|80.0|-0.31|43.3||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||43.30|-0.31|0.2061
70926855|NCT03858634|141348546|SUPERIORITY||LS mean difference|-161.4|STANDARD_ERROR_OF_MEAN|87.75||0.2073|TWO_SIDED|80.0|-326.83|4.12||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||4.12|-326.83|0.2073
70926856|NCT03858634|141348546|SUPERIORITY||LS mean difference|-34.4|STANDARD_ERROR_OF_MEAN|15.19||0.0371|TWO_SIDED|80.0|-54.62|-14.1||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-14.10|-54.62|0.0371
70926857|NCT03858634|141348546|SUPERIORITY||LS mean difference|-55.2|STANDARD_ERROR_OF_MEAN|37.72||0.2393|TWO_SIDED|80.0|-117.01|6.54||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||6.54|-117.01|0.2393
70926858|NCT03858634|141348546|SUPERIORITY||LS mean difference|2.4|STANDARD_ERROR_OF_MEAN|19.01||0.9019|TWO_SIDED|80.0|-22.91|27.67||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||27.67|-22.91|0.9019
70926859|NCT03858634|141348546|SUPERIORITY||LS mean difference|-149.2|STANDARD_ERROR_OF_MEAN|81.97||0.2103|TWO_SIDED|80.0|-303.77|5.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||5.35|-303.77|0.2103
70926860|NCT03858634|141348546|SUPERIORITY||LS mean difference|-22.1|STANDARD_ERROR_OF_MEAN|15.2||0.1634|TWO_SIDED|80.0|-42.4|-1.88||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-1.88|-42.40|0.1634
71046217|NCT02312713|141600652|SUPERIORITY||Mean Difference (Final Values)|-1.06||||0.33|TWO_SIDED|95.0|-3.22|1.09|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||1.09|-3.22|0.33
71046218|NCT02312713|141600652|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.72|TWO_SIDED|95.0|-2.52|1.74|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||1.74|-2.52|0.72
71046219|NCT02312713|141600652|SUPERIORITY||Mean Difference (Final Values)|0.65||||0.56|TWO_SIDED|95.0|-1.56|2.86|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||2.86|-1.56|0.56
70926861|NCT03858634|141348546|SUPERIORITY||LS mean difference|-48.6|STANDARD_ERROR_OF_MEAN|36.28||0.2727|TWO_SIDED|80.0|-108.04|10.8||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||10.80|-108.04|0.2727
71046220|NCT02312713|141600652|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|2.19||||0.01|TWO_SIDED|95.0|0.48|3.9|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||3.9|0.48|0.01
71103438|NCT00863304|141714819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.24||0.464|TWO_SIDED|95.0|-0.66|0.3||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.30|-0.66|0.464
71103439|NCT00863304|141714819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.22|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.72|-0.72||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.72|-1.72|<0.001
70926862|NCT03858634|141348546|SUPERIORITY||LS mean difference|-9.6|STANDARD_ERROR_OF_MEAN|17.29||0.5839|TWO_SIDED|80.0|-32.65|13.36||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||13.36|-32.65|0.5839
70926863|NCT03858634|141348546|SUPERIORITY||LS mean difference|-167.8|STANDARD_ERROR_OF_MEAN|76.58||0.1597|TWO_SIDED|80.0|-312.25|-23.45||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-23.45|-312.25|0.1597
70926864|NCT03858634|141348546|SUPERIORITY||LS mean difference|-27.1|STANDARD_ERROR_OF_MEAN|16.27||0.1138|TWO_SIDED|80.0|-48.81|-5.43||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-5.43|-48.81|0.1138
70926865|NCT03858634|141348546|SUPERIORITY||LS mean difference|-62.0|STANDARD_ERROR_OF_MEAN|24.93||0.0888|TWO_SIDED|80.0|-102.78|-21.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-21.13|-102.78|0.0888
70926866|NCT03858634|141348546|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|18.19||0.9741|TWO_SIDED|80.0|-24.79|23.6||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||23.60|-24.79|0.9741
70926867|NCT03858634|141348546|SUPERIORITY||LS mean difference|-159.2|STANDARD_ERROR_OF_MEAN|65.42||0.1354|TWO_SIDED|80.0|-282.59|-35.87||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-35.87|-282.59|0.1354
70926868|NCT03858634|141348546|SUPERIORITY||LS mean difference|-26.5|STANDARD_ERROR_OF_MEAN|17.21||0.1425|TWO_SIDED|80.0|-49.41|-3.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-3.52|-49.41|0.1425
70926869|NCT03858634|141348546|SUPERIORITY||LS mean difference|-54.6|STANDARD_ERROR_OF_MEAN|26.61||0.1326|TWO_SIDED|80.0|-98.18|-11.01||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-11.01|-98.18|0.1326
70926870|NCT03858634|141348546|OTHER||LS mean difference|-4.2|STANDARD_ERROR_OF_MEAN|20.87||0.8433|TWO_SIDED|80.0|-31.95|23.58||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||23.58|-31.95|0.8433
70926871|NCT03858634|141348546|SUPERIORITY||LS mean difference|-130.8|STANDARD_ERROR_OF_MEAN|38.5||0.0768|TWO_SIDED|80.0|-203.39|-58.19||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-58.19|-203.39|0.0768
70926872|NCT03858634|141348546|SUPERIORITY||LS mean difference|-18.6|STANDARD_ERROR_OF_MEAN|18.69||0.3341|TWO_SIDED|80.0|-43.49|6.34||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||6.34|-43.49|0.3341
70926873|NCT03858634|141348548|SUPERIORITY||LS mean difference|-40.9|STANDARD_ERROR_OF_MEAN|40.82||0.4995|TWO_SIDED|80.0|-166.52|84.74||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||84.74|-166.52|0.4995
70926874|NCT03858634|141348548|SUPERIORITY||LS mean difference|-3.7|STANDARD_ERROR_OF_MEAN|9.59||0.7071|TWO_SIDED|80.0|-16.37|9.06||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||9.06|-16.37|0.7071
70926875|NCT03858634|141348548|SUPERIORITY||LS mean difference|-52.5|STANDARD_ERROR_OF_MEAN|9.39||0.0305|TWO_SIDED|80.0|-70.18|-34.77||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||-34.77|-70.18|0.0305
70926876|NCT03858634|141348548|SUPERIORITY||LS mean difference|-6.6|STANDARD_ERROR_OF_MEAN|9.33||0.4884|TWO_SIDED|80.0|-19.01|5.81||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||5.81|-19.01|0.4884
70926877|NCT03858634|141348548|SUPERIORITY||LS mean difference|-45.3|STANDARD_ERROR_OF_MEAN|31.63||0.2885|TWO_SIDED|80.0|-104.93|14.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||14.35|-104.93|0.2885
70926878|NCT03858634|141348548|SUPERIORITY||LS mean difference|5.2|STANDARD_ERROR_OF_MEAN|11.24||0.6505|TWO_SIDED|80.0|-9.73|20.06||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||20.06|-9.73|0.6505
70926879|NCT03858634|141348548|SUPERIORITY||LS mean difference|-72.1|STANDARD_ERROR_OF_MEAN|5.72||0.0062|TWO_SIDED|80.0|-82.91|-61.34||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-61.34|-82.91|0.0062
70926880|NCT03858634|141348548|SUPERIORITY||LS mean difference|-19.6|STANDARD_ERROR_OF_MEAN|9.62||0.0571|TWO_SIDED|80.0|-32.34|-6.76||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-6.76|-32.34|0.0571
70926881|NCT03858634|141348548|SUPERIORITY||LS mean difference|-50.1|STANDARD_ERROR_OF_MEAN|0.0|||TWO_SIDED|||||||||Change at Week 6||||
70926882|NCT03858634|141348548|SUPERIORITY||LS mean difference|-4.3|STANDARD_ERROR_OF_MEAN|10.65||0.6927|TWO_SIDED|80.0|-18.38|9.84||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||9.84|-18.38|0.6927
70926883|NCT03858634|141348548|SUPERIORITY||LS mean difference|-65.6|STANDARD_ERROR_OF_MEAN|4.08||0.0038|TWO_SIDED|80.0|-73.33|-57.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-57.94|-73.33|0.0038
70926884|NCT03858634|141348548|SUPERIORITY||LS mean difference|-17.4|STANDARD_ERROR_OF_MEAN|9.82||0.094|TWO_SIDED|80.0|-30.43|-4.3||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-4.30|-30.43|0.0940
70926885|NCT03858634|141348548|SUPERIORITY||LS mean difference|-72.4|STANDARD_ERROR_OF_MEAN|19.73||0.1694|TWO_SIDED|80.0|-133.1|-11.65||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-11.65|-133.10|0.1694
70926886|NCT03858634|141348548|SUPERIORITY||LS mean difference|2.8|STANDARD_ERROR_OF_MEAN|10.07||0.7811|TWO_SIDED|80.0|-10.5|16.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||16.18|-10.50|0.7811
71103440|NCT00863304|141714819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.55|-0.54||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.54|-1.55|<0.001
71103441|NCT00863304|141714819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.26||0.014|TWO_SIDED|95.0|-1.14|-0.13||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.13|-1.14|0.014
71103442|NCT00863304|141714819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.26||0.023|TWO_SIDED|95.0|-1.09|-0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.08|-1.09|0.023
71103443|NCT00863304|141714819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.26||0.114|TWO_SIDED|95.0|-0.92|0.1||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.10|-0.92|0.114
71103444|NCT00863304|141714820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.23||0.029|TWO_SIDED|95.0|-0.94|-0.05||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.05|-0.94|0.029
71103445|NCT00863304|141714820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.23||0.214|TWO_SIDED|95.0|-0.73|0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.16|-0.73|0.214
70926887|NCT03858634|141348548|SUPERIORITY||LS mean difference|-68.2|STANDARD_ERROR_OF_MEAN|2.28||0.0011|TWO_SIDED|80.0|-72.51|-63.91||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-63.91|-72.51|0.0011
70926888|NCT03858634|141348548|SUPERIORITY||LS mean difference|-23.4|STANDARD_ERROR_OF_MEAN|9.52||0.0245|TWO_SIDED|80.0|-36.02|-10.7||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-10.70|-36.02|0.0245
71103446|NCT00863304|141714820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.21|-0.32||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.32|-1.21|<0.001
71103447|NCT00863304|141714820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.23||0.234|TWO_SIDED|95.0|-0.18|0.72||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.72|-0.18|0.234
71103448|NCT00863304|141714820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.23||0.034|TWO_SIDED|95.0|0.04|0.93||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.93|0.04|0.034
70926889|NCT03858634|141348548|SUPERIORITY||LS mean difference|-61.8|STANDARD_ERROR_OF_MEAN|5.87||0.0603|TWO_SIDED|80.0|-79.88|-43.74||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-43.74|-79.88|0.0603
71103449|NCT00863304|141714820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.59|-0.67||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.67|-1.59|<0.001
70926890|NCT03858634|141348548|SUPERIORITY||LS mean difference|7.9|STANDARD_ERROR_OF_MEAN|9.89||0.4365|TWO_SIDED|80.0|-5.29|21.04||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||21.04|-5.29|0.4365
70926891|NCT03858634|141348548|SUPERIORITY||LS mean difference|-68.7|STANDARD_ERROR_OF_MEAN|10.3||0.0218|TWO_SIDED|80.0|-88.11|-49.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-49.26|-88.11|0.0218
70926892|NCT03858634|141348548|SUPERIORITY||LS mean difference|-19.5|STANDARD_ERROR_OF_MEAN|12.07||0.1238|TWO_SIDED|80.0|-35.65|-3.45||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-3.45|-35.65|0.1238
70926893|NCT03858634|141348548|SUPERIORITY||LS mean difference|-54.8|STANDARD_ERROR_OF_MEAN|23.38||0.1437|TWO_SIDED|80.0|-98.88|-10.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-10.72|-98.88|0.1437
70926894|NCT03858634|141348548|SUPERIORITY||LS mean difference|0.9|STANDARD_ERROR_OF_MEAN|10.14||0.9279|TWO_SIDED|80.0|-12.56|14.43||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||14.43|-12.56|0.9279
70926895|NCT03858634|141348548|SUPERIORITY||LS mean difference|-59.5|STANDARD_ERROR_OF_MEAN|9.67||0.0254|TWO_SIDED|80.0|-77.69|-41.24||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-41.24|-77.69|0.0254
70926896|NCT03858634|141348548|SUPERIORITY||LS mean difference|-18.8|STANDARD_ERROR_OF_MEAN|10.8||0.0994|TWO_SIDED|80.0|-33.23|-4.43||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-4.43|-33.23|0.0994
70926897|NCT03858634|141348548|SUPERIORITY||LS mean difference|-45.7|STANDARD_ERROR_OF_MEAN|39.36||0.3656|TWO_SIDED|80.0|-119.9|28.54||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||28.54|-119.90|0.3656
70926898|NCT03858634|141348548|SUPERIORITY||LS mean difference|-2.9|STANDARD_ERROR_OF_MEAN|8.92||0.7465|TWO_SIDED|80.0|-14.79|8.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||8.94|-14.79|0.7465
70926899|NCT03858634|141348548|SUPERIORITY||LS mean difference|-82.3|STANDARD_ERROR_OF_MEAN|10.3||0.0153|TWO_SIDED|80.0|-101.75|-62.9||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-62.90|-101.75|0.0153
70926900|NCT03858634|141348548|SUPERIORITY||LS mean difference|-16.6|STANDARD_ERROR_OF_MEAN|12.97||0.2184|TWO_SIDED|80.0|-33.88|0.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||0.72|-33.88|0.2184
70926901|NCT03858634|141348548|SUPERIORITY||LS mean difference|-8.1|STANDARD_ERROR_OF_MEAN|25.78||0.7726|TWO_SIDED|80.0|-50.37|34.07||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||34.07|-50.37|0.7726
70926902|NCT03858634|141348548|SUPERIORITY||LS mean difference|-9.2|STANDARD_ERROR_OF_MEAN|12.66||0.476|TWO_SIDED|80.0|-26.07|7.63||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||7.63|-26.07|0.4760
70926903|NCT03858634|141348548|SUPERIORITY||LS mean difference|-82.1|STANDARD_ERROR_OF_MEAN|9.12||0.0121|TWO_SIDED|80.0|-99.26|-64.87||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-64.87|-99.26|0.0121
70926904|NCT03858634|141348548|SUPERIORITY||LS mean difference|-13.0|STANDARD_ERROR_OF_MEAN|13.06||0.3329|TWO_SIDED|80.0|-30.43|4.4||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||4.40|-30.43|0.3329
70926905|NCT03858634|141348548|SUPERIORITY||LS mean difference|-1.7|STANDARD_ERROR_OF_MEAN|28.46||0.9564|TWO_SIDED|80.0|-48.31|44.92||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||44.92|-48.31|0.9564
71103450|NCT00863304|141714820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.37|-0.45||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.45|-1.37|<0.001
70926906|NCT03858634|141348548|SUPERIORITY||LS mean difference|-7.9|STANDARD_ERROR_OF_MEAN|13.49||0.5661|TWO_SIDED|80.0|-25.84|10.06||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||10.06|-25.84|0.5661
71103451|NCT00863304|141714820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.24||0.012|TWO_SIDED|95.0|-1.05|-0.13||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.13|-1.05|0.012
70926907|NCT03858634|141348548|SUPERIORITY||LS mean difference|-82.1|STANDARD_ERROR_OF_MEAN|9.12||0.0121|TWO_SIDED|80.0|-99.26|-64.87||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-64.87|-99.26|0.0121
70926908|NCT03858634|141348548|SUPERIORITY||LS mean difference|-11.1|STANDARD_ERROR_OF_MEAN|13.7||0.4275|TWO_SIDED|80.0|-29.4|7.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||7.13|-29.40|0.4275
70926909|NCT03858634|141348553|SUPERIORITY||LS mean difference|-27.9|STANDARD_ERROR_OF_MEAN|40.54||0.5403|TWO_SIDED|80.0|-94.32|38.46||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||38.46|-94.32|0.5403
70926910|NCT03858634|141348553|SUPERIORITY||LS mean difference|376.1|STANDARD_ERROR_OF_MEAN|631.83||0.5587|TWO_SIDED|80.0|-462.83|1214.97||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||1214.97|-462.83|0.5587
70926911|NCT03858634|141348553|SUPERIORITY||LS mean difference|-67.7|STANDARD_ERROR_OF_MEAN|72.99||0.4516|TWO_SIDED|80.0|-205.33|69.93||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||69.93|-205.33|0.4516
70926912|NCT03858634|141348553|SUPERIORITY||LS mean difference|-12.5|STANDARD_ERROR_OF_MEAN|9.5||0.2052|TWO_SIDED|80.0|-25.13|0.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||0.15|-25.13|0.2052
70926913|NCT03858634|141348553|SUPERIORITY||LS mean difference|-59.4|STANDARD_ERROR_OF_MEAN|38.89||0.224|TWO_SIDED|80.0|-123.09|4.28||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||4.28|-123.09|0.2240
70926914|NCT03858634|141348553|SUPERIORITY||LS mean difference|39.5|STANDARD_ERROR_OF_MEAN|48.33||0.4242|TWO_SIDED|80.0|-24.7|103.65||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||103.65|-24.70|0.4242
70926915|NCT03858634|141348553|SUPERIORITY||LS mean difference|-77.2|STANDARD_ERROR_OF_MEAN|78.61||0.4295|TWO_SIDED|80.0|-225.44|71.01||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||71.01|-225.44|0.4295
70926916|NCT03858634|141348553|SUPERIORITY||LS mean difference|-18.7|STANDARD_ERROR_OF_MEAN|14.97||0.2272|TWO_SIDED|80.0|-38.64|1.2||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||1.20|-38.64|0.2272
70926917|NCT03858634|141348553|SUPERIORITY||LS mean difference|-55.1|STANDARD_ERROR_OF_MEAN|48.9||0.3416|TWO_SIDED|80.0|-135.23|24.95||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||24.95|-135.23|0.3416
70926918|NCT03858634|141348553|SUPERIORITY||LS mean difference|57.6|STANDARD_ERROR_OF_MEAN|69.75||0.4192|TWO_SIDED|80.0|-35.02|150.19||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||150.19|-35.02|0.4192
70926919|NCT03858634|141348553|SUPERIORITY||LS mean difference|-66.8|STANDARD_ERROR_OF_MEAN|87.42||0.5245|TWO_SIDED|80.0|-231.66|98.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||98.02|-231.66|0.5245
70926920|NCT03858634|141348553|SUPERIORITY||LS mean difference|-17.8|STANDARD_ERROR_OF_MEAN|13.31||0.1988|TWO_SIDED|80.0|-35.47|-0.05||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||-0.05|-35.47|0.1988
70926921|NCT03858634|141348553|SUPERIORITY||LS mean difference|-69.2|STANDARD_ERROR_OF_MEAN|56.11||0.3054|TWO_SIDED|80.0|-161.08|22.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||22.72|-161.08|0.3054
70926922|NCT03858634|141348553|SUPERIORITY||LS mean difference|229.4|STANDARD_ERROR_OF_MEAN|377.23||0.5504|TWO_SIDED|80.0|-271.51|730.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||730.22|-271.51|0.5504
70926923|NCT03858634|141348553|SUPERIORITY||LS mean difference|-71.2|STANDARD_ERROR_OF_MEAN|76.27||0.4493|TWO_SIDED|80.0|-214.96|72.65||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||72.65|-214.96|0.4493
70926924|NCT03858634|141348553|SUPERIORITY||LS mean difference|-40.3|STANDARD_ERROR_OF_MEAN|20.63||0.0665|TWO_SIDED|80.0|-67.74|-12.85||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-12.85|-67.74|0.0665
70926925|NCT03858634|141348553|SUPERIORITY||LS mean difference|-78.7|STANDARD_ERROR_OF_MEAN|54.04||0.2411|TWO_SIDED|80.0|-167.25|9.75||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||9.75|-167.25|0.2411
70926926|NCT03858634|141348553|SUPERIORITY||LS mean difference|60.8|STANDARD_ERROR_OF_MEAN|79.3||0.4528|TWO_SIDED|80.0|-44.51|166.08||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||166.08|-44.51|0.4528
70926927|NCT03858634|141348553|SUPERIORITY||LS mean difference|-41.4|STANDARD_ERROR_OF_MEAN|75.46||0.6381|TWO_SIDED|80.0|-183.72|100.85||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||100.85|-183.72|0.6381
70926928|NCT03858634|141348553|SUPERIORITY||LS mean difference|-31.5|STANDARD_ERROR_OF_MEAN|17.22||0.0837|TWO_SIDED|80.0|-54.44|-8.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||-8.62|-54.44|0.0837
71103452|NCT00863304|141714820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.24||0.023|TWO_SIDED|95.0|-1.0|-0.07||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.07|-1.00|0.023
71103453|NCT00863304|141714820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.24||0.175|TWO_SIDED|95.0|-0.78|0.14||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.14|-0.78|0.175
71103454|NCT00863304|141714820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.09|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.55|-0.63||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.63|-1.55|<0.001
70926929|NCT03858634|141348553|SUPERIORITY||LS mean difference|-74.7|STANDARD_ERROR_OF_MEAN|66.45||0.3428|TWO_SIDED|80.0|-183.53|34.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||34.13|-183.53|0.3428
70926930|NCT03858634|141348553|SUPERIORITY||LS Mean Difference|21.8|STANDARD_ERROR_OF_MEAN|22.93||0.3533|TWO_SIDED|80.0|-8.63|52.27||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||52.27|-8.63|0.3533
70926931|NCT03858634|141348553|SUPERIORITY||LS Mean Difference|-63.9|STANDARD_ERROR_OF_MEAN|56.53||0.3755|TWO_SIDED|80.0|-170.51|42.66||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||42.66|-170.51|0.3755
70926932|NCT03858634|141348553|SUPERIORITY||LS Mean Difference|-37.6|STANDARD_ERROR_OF_MEAN|15.6||0.0268|TWO_SIDED|80.0|-58.39|-16.87||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-16.87|-58.39|0.0268
70926933|NCT03858634|141348553|SUPERIORITY||LS Mean Difference|-79.5|STANDARD_ERROR_OF_MEAN|43.79||0.1672|TWO_SIDED|80.0|-151.2|-7.75||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-7.75|-151.20|0.1672
70926934|NCT03858634|141348553|SUPERIORITY||LS Mean Difference|43.7|STANDARD_ERROR_OF_MEAN|45.81||0.3518|TWO_SIDED|80.0|-17.09|104.55||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||104.55|-17.09|0.3518
70926935|NCT03858634|141348553|SUPERIORITY||LS Mean Difference|-68.7|STANDARD_ERROR_OF_MEAN|49.22||0.2974|TWO_SIDED|80.0|-161.52|24.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||24.09|-161.52|0.2974
70926936|NCT03858634|141348553|SUPERIORITY||LS Mean Difference|-38.1|STANDARD_ERROR_OF_MEAN|18.6||0.0555|TWO_SIDED|80.0|-62.83|-13.33||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-13.33|-62.83|0.0555
70926937|NCT03858634|141348553|SUPERIORITY||LS Mean Difference|-78.3|STANDARD_ERROR_OF_MEAN|56.72||0.2614|TWO_SIDED|80.0|-171.17|14.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||14.62|-171.17|0.2614
70926938|NCT03858634|141348553|SUPERIORITY||LS Mean Difference|31.7|STANDARD_ERROR_OF_MEAN|37.89||0.4134|TWO_SIDED|80.0|-18.62|81.98||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||81.98|-18.62|0.4134
70926939|NCT03858634|141348553|SUPERIORITY||LS Mean Difference|-69.6|STANDARD_ERROR_OF_MEAN|44.99||0.262|TWO_SIDED|80.0|-154.44|15.24||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||15.24|-154.44|0.2620
70926940|NCT03858634|141348553|SUPERIORITY||LS Mean Difference|-40.2|STANDARD_ERROR_OF_MEAN|16.7||0.0269|TWO_SIDED|80.0|-62.46|-18.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-18.02|-62.46|0.0269
70926941|NCT03858634|141348553|SUPERIORITY||LS Mean Difference|-81.2|STANDARD_ERROR_OF_MEAN|45.32||0.1709|TWO_SIDED|80.0|-155.46|-7.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-7.02|-155.46|0.1709
70926942|NCT03858634|141348553|SUPERIORITY||LS Mean Difference|42.9|STANDARD_ERROR_OF_MEAN|12.98||0.0042|TWO_SIDED|80.0|25.61|60.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||60.22|25.61|0.0042
70926943|NCT03858634|141348553|SUPERIORITY||LS Mean Difference|-53.2|STANDARD_ERROR_OF_MEAN|47.22||0.3772|TWO_SIDED|80.0|-142.19|35.88||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||35.88|-142.19|0.3772
70926944|NCT03858634|141348553|SUPERIORITY||LS Mean Difference|-28.3|STANDARD_ERROR_OF_MEAN|15.54||0.0857|TWO_SIDED|80.0|-49.06|-7.63||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-7.63|-49.06|0.0857
70926945|NCT03858634|141348553|SUPERIORITY||LS Mean Difference|-77.3|STANDARD_ERROR_OF_MEAN|26.34||0.0607|TWO_SIDED|80.0|-120.48|-34.2||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-34.20|-120.48|0.0607
70926946|NCT03858634|141348553|SUPERIORITY||LS Mean Difference|88.8|STANDARD_ERROR_OF_MEAN|124.79||0.4862|TWO_SIDED|80.0|-77.57|255.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||255.22|-77.57|0.4862
71103455|NCT00863304|141714820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.34|-0.41||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.41|-1.34|<0.001
71103456|NCT00863304|141714820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.24||0.017|TWO_SIDED|95.0|-1.03|-0.1||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.10|-1.03|0.017
70926947|NCT03858634|141348553|SUPERIORITY||LS Mean Difference|-53.2|STANDARD_ERROR_OF_MEAN|49.73||0.3968|TWO_SIDED|80.0|-146.96|40.58||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||40.58|-146.96|0.3968
70926948|NCT03858634|141348553|SUPERIORITY||LS Mean Difference|-24.2|STANDARD_ERROR_OF_MEAN|16.57||0.1624|TWO_SIDED|80.0|-46.31|-2.11||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-2.11|-46.31|0.1624
70926949|NCT03858634|141348553|SUPERIORITY||LS Mean Difference|-76.8|STANDARD_ERROR_OF_MEAN|37.75||0.1349|TWO_SIDED|80.0|-138.58|-14.93||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-14.93|-138.58|0.1349
70926950|NCT03858634|141348553|SUPERIORITY||LS Mean Difference|45.5|STANDARD_ERROR_OF_MEAN|21.81||0.0525|TWO_SIDED|80.0|16.38|74.56||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||74.56|16.38|0.0525
70926951|NCT03858634|141348553|SUPERIORITY||LS Mean Difference|-76.6|STANDARD_ERROR_OF_MEAN|50.98||0.2719|TWO_SIDED|80.0|-172.71|19.55||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||19.55|-172.71|0.2719
70926952|NCT03858634|141348553|SUPERIORITY||LS Mean Difference|-30.7|STANDARD_ERROR_OF_MEAN|17.39||0.0957|TWO_SIDED|80.0|-53.86|-7.49||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-7.49|-53.86|0.0957
70926953|NCT03858634|141348553|SUPERIORITY||LS Mean Difference|-79.8|STANDARD_ERROR_OF_MEAN|32.98||0.0942|TWO_SIDED|80.0|-133.83|-25.78||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-25.78|-133.83|0.0942
70926954|NCT03858634|141348553|SUPERIORITY||LS Mean Difference|34.6|STANDARD_ERROR_OF_MEAN|23.6||0.1606|TWO_SIDED|80.0|3.16|66.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||66.09|3.16|0.1606
70926955|NCT03858634|141348553|SUPERIORITY||LS Mean Difference|-77.0|STANDARD_ERROR_OF_MEAN|42.2||0.2096|TWO_SIDED|80.0|-156.58|2.58||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||2.58|-156.58|0.2096
70926956|NCT03858634|141348553|SUPERIORITY||LS Mean Difference|-29.3|STANDARD_ERROR_OF_MEAN|18.32||0.1279|TWO_SIDED|80.0|-53.74|-4.89||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-4.89|-53.74|0.1279
70926957|NCT03858634|141348553|SUPERIORITY||LS Mean Difference|-75.0|STANDARD_ERROR_OF_MEAN|23.17||0.0479|TWO_SIDED|80.0|-112.96|-37.08||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-37.08|-112.96|0.0479
70926958|NCT03858634|141348553|SUPERIORITY||LS Mean Difference|32.8|STANDARD_ERROR_OF_MEAN|22.91||0.17|TWO_SIDED|80.0|2.28|63.37||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||63.37|2.28|0.1700
70926959|NCT03858634|141348553|SUPERIORITY||LS Mean Difference|-80.1|STANDARD_ERROR_OF_MEAN|29.67||0.1142|TWO_SIDED|80.0|-136.03|-24.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-24.15|-136.03|0.1142
71103457|NCT00863304|141714820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.24||0.027|TWO_SIDED|95.0|-0.99|-0.06||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.06|-0.99|0.027
71103458|NCT00863304|141714820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.24||0.19|TWO_SIDED|95.0|-0.78|0.15||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.15|-0.78|0.190
70926960|NCT03858634|141348553|SUPERIORITY||LS Mean Difference|-18.0|STANDARD_ERROR_OF_MEAN|20.82||0.398|TWO_SIDED|80.0|-45.8|9.71||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||9.71|-45.80|0.3980
70926961|NCT03858634|141348555|SUPERIORITY||LS mean difference|-13.2|STANDARD_ERROR_OF_MEAN|17.11||0.4979|TWO_SIDED|80.0|-41.17|14.86||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||14.86|-41.17|0.4979
70926962|NCT03858634|141348555|SUPERIORITY||LS mean difference|21.7|STANDARD_ERROR_OF_MEAN|12.88||0.1079|TWO_SIDED|80.0|4.63|38.83||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||38.83|4.63|0.1079
70926963|NCT03858634|141348555|SUPERIORITY||LS mean difference|-35.6|STANDARD_ERROR_OF_MEAN|41.7||0.4837|TWO_SIDED|80.0|-114.19|43.07||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||43.07|-114.19|0.4837
70926964|NCT03858634|141348555|SUPERIORITY||LS mean difference|-10.5|STANDARD_ERROR_OF_MEAN|4.14||0.0208|TWO_SIDED|80.0|-15.99|-4.98||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||-4.98|-15.99|0.0208
70926965|NCT03858634|141348555|SUPERIORITY||LS mean difference|-16.2|STANDARD_ERROR_OF_MEAN|23.54||0.5413|TWO_SIDED|80.0|-54.74|22.38||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||22.38|-54.74|0.5413
70926966|NCT03858634|141348555|SUPERIORITY||LS mean difference|17.5|STANDARD_ERROR_OF_MEAN|12.22||0.1683|TWO_SIDED|80.0|1.28|33.74||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||33.74|1.28|0.1683
70926967|NCT03858634|141348555|SUPERIORITY||LS mean difference|-58.8|STANDARD_ERROR_OF_MEAN|54.45||0.3933|TWO_SIDED|80.0|-161.43|43.89||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||43.89|-161.43|0.3933
70926968|NCT03858634|141348555|SUPERIORITY||LS mean difference|-5.7|STANDARD_ERROR_OF_MEAN|6.25||0.3705|TWO_SIDED|80.0|-14.06|2.58||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||2.58|-14.06|0.3705
70926969|NCT03858634|141348555|SUPERIORITY||LS mean difference|-23.0|STANDARD_ERROR_OF_MEAN|35.63||0.5644|TWO_SIDED|80.0|-81.36|35.34||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||35.34|-81.36|0.5644
70926970|NCT03858634|141348555|SUPERIORITY||LS mean difference|6.6|STANDARD_ERROR_OF_MEAN|13.82||0.6384|TWO_SIDED|80.0|-11.75|24.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||24.94|-11.75|0.6384
70926971|NCT03858634|141348555|SUPERIORITY||LS mean difference|-58.6|STANDARD_ERROR_OF_MEAN|58.62||0.4229|TWO_SIDED|80.0|-169.13|51.95||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||51.95|-169.13|0.4229
70926972|NCT03858634|141348555|SUPERIORITY||LS mean difference|-16.3|STANDARD_ERROR_OF_MEAN|11.38||0.1688|TWO_SIDED|80.0|-31.47|-1.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||-1.18|-31.47|0.1688
70926973|NCT03858634|141348555|SUPERIORITY||LS mean difference|-59.6|STANDARD_ERROR_OF_MEAN|28.11||0.1243|TWO_SIDED|80.0|-105.59|-13.53||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-13.53|-105.59|0.1243
70926974|NCT03858634|141348555|SUPERIORITY||LS mean difference|6.9|STANDARD_ERROR_OF_MEAN|16.79||0.6841|TWO_SIDED|80.0|-15.35|29.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||29.22|-15.35|0.6841
70926975|NCT03858634|141348555|SUPERIORITY||LS mean difference|-53.4|STANDARD_ERROR_OF_MEAN|49.83||0.3963|TWO_SIDED|80.0|-147.31|40.59||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||40.59|-147.31|0.3963
70926976|NCT03858634|141348555|SUPERIORITY||LS mean difference|-24.1|STANDARD_ERROR_OF_MEAN|11.85||0.0571|TWO_SIDED|80.0|-39.85|-8.32||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-8.32|-39.85|0.0571
70926977|NCT03858634|141348555|SUPERIORITY||LS mean difference|-35.3|STANDARD_ERROR_OF_MEAN|40.32||0.4457|TWO_SIDED|80.0|-101.32|30.73||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||30.73|-101.32|0.4457
70926978|NCT03858634|141348555|SUPERIORITY||LS mean difference|4.4|STANDARD_ERROR_OF_MEAN|17.99||0.8075|TWO_SIDED|80.0|-19.44|28.32||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||28.32|-19.44|0.8075
70926979|NCT03858634|141348555|SUPERIORITY||LS mean difference|-57.7|STANDARD_ERROR_OF_MEAN|55.75||0.4093|TWO_SIDED|80.0|-162.84|47.4||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||47.40|-162.84|0.4093
70926980|NCT03858634|141348555|SUPERIORITY||LS mean difference|-27.6|STANDARD_ERROR_OF_MEAN|13.4||0.0543|TWO_SIDED|80.0|-45.42|-9.76||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||-9.76|-45.42|0.0543
70926981|NCT03858634|141348555|SUPERIORITY||LS mean difference|-31.0|STANDARD_ERROR_OF_MEAN|37.75||0.4711|TWO_SIDED|80.0|-92.88|30.78||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||30.78|-92.88|0.4711
70926982|NCT03858634|141348555|SUPERIORITY||LS mean difference|13.0|STANDARD_ERROR_OF_MEAN|14.89||0.3925|TWO_SIDED|80.0|-6.74|32.79||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||32.79|-6.74|0.3925
70926983|NCT03858634|141348555|SUPERIORITY||LS mean difference|-48.7|STANDARD_ERROR_OF_MEAN|61.24||0.5095|TWO_SIDED|80.0|-164.22|66.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||66.72|-164.22|0.5095
70926984|NCT03858634|141348555|SUPERIORITY||LS mean difference|-33.8|STANDARD_ERROR_OF_MEAN|13.22||0.0199|TWO_SIDED|80.0|-51.35|-16.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-16.18|-51.35|0.0199
71009908|NCT03091920|141526969|OTHER|No statistical testing was performed.|Least squares mean difference|-4.73|STANDARD_ERROR_OF_MEAN|2.67|||TWO_SIDED|95.0|-10.27|0.81|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 14||0.81|-10.27|
70926985|NCT03858634|141348555|SUPERIORITY||LS mean difference|-42.8|STANDARD_ERROR_OF_MEAN|34.48||0.3029|TWO_SIDED|80.0|-99.26|13.69||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||13.69|-99.26|0.3029
70926986|NCT03858634|141348555|SUPERIORITY||LS mean difference|10.9|STANDARD_ERROR_OF_MEAN|12.97||0.4094|TWO_SIDED|80.0|-6.28|28.16||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||28.16|-6.28|0.4094
70926987|NCT03858634|141348555|SUPERIORITY||LS mean difference|-49.8|STANDARD_ERROR_OF_MEAN|58.25||0.4828|TWO_SIDED|80.0|-159.63|60.05||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||60.05|-159.63|0.4828
70926988|NCT03858634|141348555|SUPERIORITY||LS mean difference|-32.8|STANDARD_ERROR_OF_MEAN|14.66||0.0383|TWO_SIDED|80.0|-52.26|-13.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-13.26|-52.26|0.0383
70926989|NCT03858634|141348555|SUPERIORITY||LS mean difference|-26.1|STANDARD_ERROR_OF_MEAN|37.1||0.5322|TWO_SIDED|80.0|-86.66|34.65||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||34.65|-86.66|0.5322
70926990|NCT03858634|141348555|SUPERIORITY||LS mean difference|-6.2|STANDARD_ERROR_OF_MEAN|13.71||0.6577|TWO_SIDED|80.0|-24.38|12.03||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||12.03|-24.38|0.6577
70926991|NCT03858634|141348555|SUPERIORITY||LS mean difference|-38.3|STANDARD_ERROR_OF_MEAN|67.21||0.6259|TWO_SIDED|80.0|-165.08|88.4||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||88.40|-165.08|0.6259
70926992|NCT03858634|141348555|SUPERIORITY||LS mean difference|-35.7|STANDARD_ERROR_OF_MEAN|15.27||0.0312|TWO_SIDED|80.0|-56.01|-15.38||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-15.38|-56.01|0.0312
71009909|NCT03091920|141526970|OTHER|No statistical testing was performed.|Least squares mean difference|-4.87|STANDARD_ERROR_OF_MEAN|2.86|||TWO_SIDED|95.0|-10.8|1.06|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||1.06|-10.80|
71103459|NCT00863304|141714820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.63|-0.68||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.68|-1.63|<0.001
70926993|NCT03858634|141348555|SUPERIORITY||LS mean difference|-108.3|STANDARD_ERROR_OF_MEAN|18.73||0.0103|TWO_SIDED|80.0|-138.97|-77.61||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||-77.61|-138.97|0.0103
71103460|NCT00863304|141714820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.55|-0.6||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.60|-1.55|<0.001
70926994|NCT03858634|141348555|SUPERIORITY||LS mean difference|10.0|STANDARD_ERROR_OF_MEAN|12.43||0.433|TWO_SIDED|80.0|-6.59|26.56||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||26.56|-6.59|0.4330
70926995|NCT03858634|141348555|SUPERIORITY||LS mean difference|-37.7|STANDARD_ERROR_OF_MEAN|64.23||0.6165|TWO_SIDED|80.0|-158.82|83.39||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||83.39|-158.82|0.6165
70926996|NCT03858634|141348555|SUPERIORITY||LS mean difference|-32.0|STANDARD_ERROR_OF_MEAN|15.13||0.0488|TWO_SIDED|80.0|-52.11|-11.84||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||-11.84|-52.11|0.0488
70926997|NCT03858634|141348555|SUPERIORITY||LS mean difference|-19.2|STANDARD_ERROR_OF_MEAN|39.9||0.6636|TWO_SIDED|80.0|-84.53|46.16||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||46.16|-84.53|0.6636
71103461|NCT00863304|141714820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.24||0.034|TWO_SIDED|95.0|-0.99|-0.04||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.04|-0.99|0.034
70926998|NCT03858634|141348555|SUPERIORITY||LS mean difference|23.9|STANDARD_ERROR_OF_MEAN|11.75||0.0583|TWO_SIDED|80.0|8.18|39.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||39.52|8.18|0.0583
71009910|NCT03091920|141526970|OTHER|No statistical testing was performed.|Least squares mean difference|-5.02|STANDARD_ERROR_OF_MEAN|2.82|||TWO_SIDED|95.0|-10.87|0.83|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||0.83|-10.87|
70926999|NCT03858634|141348555|SUPERIORITY||LS mean difference|-45.1|STANDARD_ERROR_OF_MEAN|54.87||0.4975|TWO_SIDED|80.0|-148.55|58.36||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||58.36|-148.55|0.4975
70927000|NCT03858634|141348555|SUPERIORITY||LS mean difference|-30.5|STANDARD_ERROR_OF_MEAN|15.54||0.0653|TWO_SIDED|80.0|-51.17|-9.82||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-9.82|-51.17|0.0653
71009911|NCT03091920|141526970|OTHER|No statistical testing was performed.|Least squares mean difference|-4.23|STANDARD_ERROR_OF_MEAN|2.57|||TWO_SIDED|95.0|-9.55|1.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||1.10|-9.55|
71009912|NCT03091920|141526970|OTHER|No statistical testing was performed.|Least squares mean difference|-2.15|STANDARD_ERROR_OF_MEAN|2.53|||TWO_SIDED|95.0|-7.4|3.11|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||3.11|-7.40|
70927001|NCT03858634|141348555|SUPERIORITY||LS mean difference|-23.4|STANDARD_ERROR_OF_MEAN|43.98||0.6316|TWO_SIDED|80.0|-95.42|48.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||48.62|-95.42|0.6316
70927002|NCT03858634|141348555|SUPERIORITY||LS mean difference|26.6|STANDARD_ERROR_OF_MEAN|14.68||0.0874|TWO_SIDED|80.0|7.05|46.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||46.18|7.05|0.0874
70927003|NCT03858634|141348555|SUPERIORITY||LS mean difference|-45.0|STANDARD_ERROR_OF_MEAN|50.39||0.4662|TWO_SIDED|80.0|-139.99|50.03||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||50.03|-139.99|0.4662
70927004|NCT03858634|141348555|SUPERIORITY||LS mean difference|-25.6|STANDARD_ERROR_OF_MEAN|15.12||0.1073|TWO_SIDED|80.0|-45.76|-5.51||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||-5.51|-45.76|0.1073
70927005|NCT03858634|141348555|SUPERIORITY||LS mean difference|-23.3|STANDARD_ERROR_OF_MEAN|42.31||0.6197|TWO_SIDED|80.0|-92.62|45.96||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||45.96|-92.62|0.6197
70927006|NCT03858634|141348555|SUPERIORITY||LS mean difference|20.6|STANDARD_ERROR_OF_MEAN|14.97||0.1868|TWO_SIDED|80.0|0.63|40.55||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||40.55|0.63|0.1868
70927007|NCT03858634|141348555|SUPERIORITY||LS mean difference|-55.0|STANDARD_ERROR_OF_MEAN|43.32||0.3321|TWO_SIDED|80.0|-136.65|26.71||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||26.71|-136.65|0.3321
70927008|NCT03858634|141348555|SUPERIORITY||LS mean difference|-24.8|STANDARD_ERROR_OF_MEAN|15.67||0.131|TWO_SIDED|80.0|-45.64|-3.95||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-3.95|-45.64|0.1310
70927009|NCT03858634|141348555|SUPERIORITY||LS mean difference|-12.0|STANDARD_ERROR_OF_MEAN|46.49||0.8128|TWO_SIDED|80.0|-88.15|64.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||64.13|-88.15|0.8128
71046221|NCT02312713|141600652|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|1.71||||0.06|TWO_SIDED|95.0|-0.1|3.52|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||3.52|-0.1|0.06
71103462|NCT00863304|141714820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.24||0.009|TWO_SIDED|9.0|-1.12|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-1.12|0.009
70927010|NCT03858634|141348555|SUPERIORITY||LS mean difference|24.7|STANDARD_ERROR_OF_MEAN|14.23||0.1004|TWO_SIDED|80.0|5.75|43.69||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||43.69|5.75|0.1004
70927011|NCT03858634|141348555|SUPERIORITY||LS mean difference|-62.8|STANDARD_ERROR_OF_MEAN|44.81||0.2962|TWO_SIDED|80.0|-147.28|21.71||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||21.71|-147.28|0.2962
70927012|NCT03858634|141348555|SUPERIORITY||LS mean difference|-26.5|STANDARD_ERROR_OF_MEAN|16.4||0.1236|TWO_SIDED|80.0|-48.31|-4.67||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||-4.67|-48.31|0.1236
70927013|NCT03858634|141348555|SUPERIORITY||LS mean difference|-4.5|STANDARD_ERROR_OF_MEAN|45.55||0.9276|TWO_SIDED|80.0|-79.1|70.11||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||70.11|-79.10|0.9276
70927014|NCT03858634|141348555|SUPERIORITY||LS mean difference|19.5|STANDARD_ERROR_OF_MEAN|13.46||0.1657|TWO_SIDED|80.0|1.55|37.45||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||37.45|1.55|0.1657
70927015|NCT03858634|141348555|SUPERIORITY||LS mean difference|-58.4|STANDARD_ERROR_OF_MEAN|47.8||0.3461|TWO_SIDED|80.0|-148.54|31.71||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||31.71|-148.54|0.3461
70927016|NCT03858634|141348555|SUPERIORITY||LS mean difference|-27.6|STANDARD_ERROR_OF_MEAN|16.51||0.1118|TWO_SIDED|80.0|-49.58|-5.64||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-5.64|-49.58|0.1118
70927017|NCT03858634|141348555|SUPERIORITY||LS mean difference|-18.9|STANDARD_ERROR_OF_MEAN|43.24||0.6912|TWO_SIDED|80.0|-89.75|51.89||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||51.89|-89.75|0.6912
70927018|NCT03858634|141348555|SUPERIORITY||LS mean difference|22.9|STANDARD_ERROR_OF_MEAN|13.07||0.0973|TWO_SIDED|80.0|5.5|40.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||40.35|5.50|0.0973
70927019|NCT03858634|141348555|SUPERIORITY||LS mean difference|-57.7|STANDARD_ERROR_OF_MEAN|40.33||0.289|TWO_SIDED|80.0|-133.72|18.37||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||18.37|-133.72|0.2890
70927020|NCT03858634|141348555|SUPERIORITY||LS mean difference|-21.9|STANDARD_ERROR_OF_MEAN|17.68||0.231|TWO_SIDED|80.0|-45.43|1.6||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||1.60|-45.43|0.2310
70927021|NCT03858634|141348555|SUPERIORITY||LS mean difference|-12.7|STANDARD_ERROR_OF_MEAN|45.17||0.7967|TWO_SIDED|80.0|-86.69|61.28||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||61.28|-86.69|0.7967
70927022|NCT03858634|141348555|SUPERIORITY||LS mean difference|16.5|STANDARD_ERROR_OF_MEAN|14.98||0.2868|TWO_SIDED|80.0|-3.5|36.44||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||36.44|-3.50|0.2868
70927023|NCT03858634|141348555|SUPERIORITY||LS mean difference|-64.9|STANDARD_ERROR_OF_MEAN|38.83||0.2369|TWO_SIDED|80.0|-138.08|8.37||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||8.37|-138.08|0.2369
70927024|NCT03858634|141348555|SUPERIORITY||LS mean difference|-21.9|STANDARD_ERROR_OF_MEAN|17.34||0.2228|TWO_SIDED|80.0|-44.97|1.17||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||1.17|-44.97|0.2228
70927025|NCT03858634|141348555|SUPERIORITY||LS mean difference|-14.9|STANDARD_ERROR_OF_MEAN|47.51||0.774|TWO_SIDED|80.0|-92.74|62.89||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||62.89|-92.74|0.7740
70927026|NCT03858634|141348555|SUPERIORITY||LS mean difference|15.1|STANDARD_ERROR_OF_MEAN|14.14||0.3|TWO_SIDED|80.0|-3.74|33.98||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||33.98|-3.74|0.3000
70927027|NCT03858634|141348555|SUPERIORITY||LS mean difference|-72.4|STANDARD_ERROR_OF_MEAN|31.37||0.1472|TWO_SIDED|80.0|-131.59|-13.3||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||-13.30|-131.59|0.1472
71009913|NCT03091920|141526970|OTHER|No statistical testing was performed.|Least squares mean difference|-8.74|STANDARD_ERROR_OF_MEAN|3.31|||TWO_SIDED|95.0|-15.64|-1.85|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||-1.85|-15.64|
71009914|NCT03091920|141526970|OTHER|No statistical testing was performed.|Least squares mean difference|-5.34|STANDARD_ERROR_OF_MEAN|3.12|||TWO_SIDED|95.0|-11.84|1.15|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||1.15|-11.84|
71009915|NCT03091920|141526971|OTHER|No statistical testing was performed.|Least squares mean difference|-0.45|STANDARD_ERROR_OF_MEAN|2.13|||TWO_SIDED|95.0|-4.86|3.96|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||3.96|-4.86|
71009916|NCT03091920|141526971|OTHER|No statistical testing was performed.|Least squares mean difference|-0.71|STANDARD_ERROR_OF_MEAN|2.1|||TWO_SIDED|95.0|-5.07|3.65|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||3.65|-5.07|
71046222|NCT02312713|141600653|SUPERIORITY||Mean Difference (Final Values)|-2.47||||0.03|TWO_SIDED|95.0|-4.67|-0.26|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||-0.26|-4.67|0.03
71046223|NCT02312713|141600653|SUPERIORITY||Mean Difference (Final Values)|-2.43||||0.01|TWO_SIDED|95.0|-4.31|-0.55|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||-0.55|-4.31|0.01
70927028|NCT03858634|141348555|SUPERIORITY||LS mean difference|-12.4|STANDARD_ERROR_OF_MEAN|20.56||0.5536|TWO_SIDED|80.0|-39.77|14.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||14.94|-39.77|0.5536
70927029|NCT03858634|141348555|SUPERIORITY||LS mean difference|-17.6|STANDARD_ERROR_OF_MEAN|43.65||0.7131|TWO_SIDED|80.0|-89.13|53.84||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||53.84|-89.13|0.7131
70927030|NCT03858634|141348555|SUPERIORITY||LS mean difference|13.9|STANDARD_ERROR_OF_MEAN|15.27||0.3762|TWO_SIDED|80.0|-6.49|34.24||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||34.24|-6.49|0.3762
70927031|NCT03858634|141348555|SUPERIORITY||LS mean difference|-74.1|STANDARD_ERROR_OF_MEAN|31.37||0.1419|TWO_SIDED|80.0|-133.26|-14.97||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-14.97|-133.26|0.1419
71009917|NCT03091920|141526971|OTHER|No statistical testing was performed.|Least squares mean difference|-3.32|STANDARD_ERROR_OF_MEAN|2.64|||TWO_SIDED|95.0|-8.79|2.14|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||2.14|-8.79|
71009918|NCT03091920|141526971|OTHER|No statistical testing was performed.|Least squares mean difference|-1.74|STANDARD_ERROR_OF_MEAN|2.61|||TWO_SIDED|95.0|-7.14|3.67|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||3.67|-7.14|
71009919|NCT03091920|141526971|OTHER|No statistical testing was performed.|Least squares mean difference|-1.88|STANDARD_ERROR_OF_MEAN|3.22|||TWO_SIDED|95.0|-8.58|4.83|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||4.83|-8.58|
71009920|NCT03091920|141526971|OTHER|No statistical testing was performed.|Least squares mean difference|-4.3|STANDARD_ERROR_OF_MEAN|3.08|||TWO_SIDED|95.0|-10.69|2.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||2.10|-10.69|
71009921|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|-4.45|STANDARD_ERROR_OF_MEAN|3.31|||TWO_SIDED|95.0|-11.3|2.41|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||2.41|-11.30|
71009922|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|-5.17|STANDARD_ERROR_OF_MEAN|3.34|||TWO_SIDED|95.0|-12.1|1.75|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||1.75|-12.10|
71009923|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|-5.23|STANDARD_ERROR_OF_MEAN|3.69|||TWO_SIDED|95.0|-12.87|2.42|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||2.42|-12.87|
71046224|NCT02312713|141600653|SUPERIORITY||Mean Difference (Final Values)|-0.99||||0.39|TWO_SIDED|95.0|-3.24|1.27|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||1.27|-3.24|0.39
71046225|NCT02312713|141600653|SUPERIORITY||Mean Difference (Final Values)|-1.65||||0.1|TWO_SIDED|95.0|-3.58|0.29|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||0.29|-3.58|0.1
70927032|NCT03858634|141348555|SUPERIORITY||LS mean difference|-11.6|STANDARD_ERROR_OF_MEAN|20.74||0.5817|TWO_SIDED|80.0|-39.22|15.95||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||15.95|-39.22|0.5817
70927033|NCT03858634|141348557|SUPERIORITY||LS mean difference|27.7|STANDARD_ERROR_OF_MEAN|55.77||0.6532|TWO_SIDED|80.0|-63.6|119.06||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||119.06|-63.60|0.6532
70927034|NCT03858634|141348557|SUPERIORITY||LS mean difference|23.6|STANDARD_ERROR_OF_MEAN|9.23||0.0187|TWO_SIDED|80.0|11.38|35.85||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||35.85|11.38|0.0187
70927035|NCT03858634|141348557|SUPERIORITY||LS mean difference|-39.3|STANDARD_ERROR_OF_MEAN|44.53||0.4707|TWO_SIDED|80.0|-123.27|44.68||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||44.68|-123.27|0.4707
70927036|NCT03858634|141348557|SUPERIORITY||LS mean difference|-1.8|STANDARD_ERROR_OF_MEAN|4.81||0.7108|TWO_SIDED|80.0|-8.22|4.59||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||4.59|-8.22|0.7108
70927037|NCT03858634|141348557|SUPERIORITY||LS mean difference|22.4|STANDARD_ERROR_OF_MEAN|60.36||0.7355|TWO_SIDED|80.0|-76.47|121.23||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||121.23|-76.47|0.7355
70927038|NCT03858634|141348557|SUPERIORITY||LS mean difference|16.9|STANDARD_ERROR_OF_MEAN|13.27||0.2167|TWO_SIDED|80.0|-0.66|34.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||34.52|-0.66|0.2167
70927039|NCT03858634|141348557|SUPERIORITY||LS mean difference|-63.5|STANDARD_ERROR_OF_MEAN|60.8||0.4058|TWO_SIDED|80.0|-178.16|51.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||51.13|-178.16|0.4058
70927040|NCT03858634|141348557|SUPERIORITY||LS mean difference|-6.4|STANDARD_ERROR_OF_MEAN|6.43||0.3323|TWO_SIDED|80.0|-14.95|2.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||2.15|-14.95|0.3323
70927041|NCT03858634|141348557|SUPERIORITY||LS mean difference|34.3|STANDARD_ERROR_OF_MEAN|68.11||0.6496|TWO_SIDED|80.0|-77.29|145.8||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||145.80|-77.29|0.6496
71103463|NCT00863304|141714820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.24||0.023|TWO_SIDED|95.0|-1.04|-0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.08|-1.04|0.023
71103464|NCT00863304|141714820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.12|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.6|-0.64||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.64|-1.60|<0.001
71103465|NCT00863304|141714820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.35|-0.39||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.39|-1.35|<0.001
71009924|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|-8.22|STANDARD_ERROR_OF_MEAN|3.58|||TWO_SIDED|95.0|-15.64|-0.79|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||-0.79|-15.64|
70927042|NCT03858634|141348557|SUPERIORITY||LS mean difference|13.8|STANDARD_ERROR_OF_MEAN|12.76||0.2925|TWO_SIDED|80.0|-3.12|30.7||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||30.70|-3.12|0.2925
70927043|NCT03858634|141348557|SUPERIORITY||LS mean difference|-70.7|STANDARD_ERROR_OF_MEAN|67.98||0.4074|TWO_SIDED|80.0|-198.92|57.46||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||57.46|-198.92|0.4074
70927044|NCT03858634|141348557|OTHER||LS mean difference|-15.5|STANDARD_ERROR_OF_MEAN|10.56||0.1584|TWO_SIDED|80.0|-29.6|-1.49||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||-1.49|-29.60|0.1584
70927045|NCT03858634|141348557|SUPERIORITY||LS mean difference|-22.8|STANDARD_ERROR_OF_MEAN|54.04||0.7013|TWO_SIDED|80.0|-111.31|65.69||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||65.69|-111.31|0.7013
70927046|NCT03858634|141348557|SUPERIORITY||LS mean difference|13.4|STANDARD_ERROR_OF_MEAN|16.35||0.423|TWO_SIDED|80.0|-8.3|35.05||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||35.05|-8.30|0.4230
70927047|NCT03858634|141348557|SUPERIORITY||LS mean difference|-60.6|STANDARD_ERROR_OF_MEAN|57.96||0.4055|TWO_SIDED|80.0|-169.9|48.69||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||48.69|-169.90|0.4055
71009925|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|-6.72|STANDARD_ERROR_OF_MEAN|3.65|||TWO_SIDED|95.0|-14.29|0.86|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||0.86|-14.29|
71009926|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|-3.14|STANDARD_ERROR_OF_MEAN|3.63|||TWO_SIDED|95.0|-10.66|4.38|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||4.38|-10.66|
71103466|NCT00863304|141714820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.25||0.092|TWO_SIDED|95.0|-0.9|0.07||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.07|-0.90|0.092
71103467|NCT00863304|141714820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.25||0.004|TWO_SIDED|95.0|-1.19|-0.23||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.23|-1.19|0.004
70927048|NCT03858634|141348557|SUPERIORITY||LS mean difference|-22.7|STANDARD_ERROR_OF_MEAN|11.82||0.0709|TWO_SIDED|80.0|-38.41|-6.96||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-6.96|-38.41|0.0709
70927049|NCT03858634|141348557|SUPERIORITY||LS mean difference|17.7|STANDARD_ERROR_OF_MEAN|74.17||0.8268|TWO_SIDED|80.0|-103.77|139.17||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||139.17|-103.77|0.8268
71009927|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|0.37|STANDARD_ERROR_OF_MEAN|2.45|||TWO_SIDED|95.0|-4.71|5.45|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||5.45|-4.71|
71009928|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|-0.02|STANDARD_ERROR_OF_MEAN|2.37|||TWO_SIDED|95.0|-4.94|4.91|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16||4.91|-4.94|
71009929|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|-2.33|STANDARD_ERROR_OF_MEAN|3.73|||TWO_SIDED|95.0|-10.07|5.41|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||5.41|-10.07|
71009930|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|-2.45|STANDARD_ERROR_OF_MEAN|3.77|||TWO_SIDED|95.0|-10.26|5.37|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||5.37|-10.26|
71009931|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|-0.75|STANDARD_ERROR_OF_MEAN|2.83|||TWO_SIDED|95.0|-6.62|5.13|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||5.13|-6.62|
71009932|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|-1.13|STANDARD_ERROR_OF_MEAN|2.75|||TWO_SIDED|95.0|-6.83|4.58|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||4.58|-6.83|
71103468|NCT00863304|141714820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.25||0.064|TWO_SIDED|95.0|-0.94|0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.03|-0.94|0.064
70927050|NCT03858634|141348557|SUPERIORITY||LS mean difference|12.4|STANDARD_ERROR_OF_MEAN|14.63||0.4082|TWO_SIDED|80.0|-7.03|31.75||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||31.75|-7.03|0.4082
71009933|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|-5.13|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-10.72|0.47|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||0.47|-10.72|
71009934|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|-3.64|STANDARD_ERROR_OF_MEAN|2.72|||TWO_SIDED|95.0|-9.29|2.01|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||2.01|-9.29|
71009935|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|-3.92|STANDARD_ERROR_OF_MEAN|3.52|||TWO_SIDED|95.0|-11.22|3.38|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||3.38|-11.22|
71009936|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|-2.46|STANDARD_ERROR_OF_MEAN|3.42|||TWO_SIDED|95.0|-9.54|4.63|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||4.63|-9.54|
70927051|NCT03858634|141348557|SUPERIORITY||LS mean difference|-50.4|STANDARD_ERROR_OF_MEAN|58.86||0.4818|TWO_SIDED|80.0|-161.43|60.56||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||60.56|-161.43|0.4818
71009937|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|-4.75|STANDARD_ERROR_OF_MEAN|2.96|||TWO_SIDED|95.0|-10.9|1.39|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||1.39|-10.90|
71009938|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|-1.25|STANDARD_ERROR_OF_MEAN|2.94|||TWO_SIDED|95.0|-7.35|4.85|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||4.85|-7.35|
71009939|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|-2.11|STANDARD_ERROR_OF_MEAN|3.11|||TWO_SIDED|95.0|-8.57|4.35|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||4.35|-8.57|
71009940|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|0.05|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|-6.21|6.31|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||6.31|-6.21|
71009941|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|-6.66|STANDARD_ERROR_OF_MEAN|3.65|||TWO_SIDED|95.0|-14.22|0.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||0.90|-14.22|
71009942|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|-6.38|STANDARD_ERROR_OF_MEAN|3.68|||TWO_SIDED|95.0|-14.01|1.25|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||1.25|-14.01|
71009943|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|-2.29|STANDARD_ERROR_OF_MEAN|3.38|||TWO_SIDED|95.0|-9.3|4.71|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||4.71|-9.30|
70927052|NCT03858634|141348557|SUPERIORITY||LS mean difference|-27.1|STANDARD_ERROR_OF_MEAN|13.93||0.0673|TWO_SIDED|80.0|-45.64|-8.58||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||-8.58|-45.64|0.0673
70927053|NCT03858634|141348557|SUPERIORITY||LS mean difference|29.6|STANDARD_ERROR_OF_MEAN|82.15||0.7429|TWO_SIDED|80.0|-105.0|164.1||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||164.10|-105.00|0.7429
70927054|NCT03858634|141348557|SUPERIORITY||LS mean difference|21.8|STANDARD_ERROR_OF_MEAN|13.55||0.1227|TWO_SIDED|80.0|3.88|39.79||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||39.79|3.88|0.1227
70927055|NCT03858634|141348557|SUPERIORITY||LS mean difference|-47.5|STANDARD_ERROR_OF_MEAN|58.06||0.4996|TWO_SIDED|80.0|-156.95|62.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||62.02|-156.95|0.4996
70927056|NCT03858634|141348557|SUPERIORITY||LS mean difference|-33.6|STANDARD_ERROR_OF_MEAN|13.69||0.0244|TWO_SIDED|80.0|-51.87|-15.43||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-15.43|-51.87|0.0244
70927057|NCT03858634|141348557|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|64.24||0.9967|TWO_SIDED|80.0|-105.5|104.92||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||104.92|-105.50|0.9967
70927058|NCT03858634|141348557|SUPERIORITY||LS mean difference|19.1|STANDARD_ERROR_OF_MEAN|13.57||0.1739|TWO_SIDED|80.0|1.15|37.12||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||37.12|1.15|0.1739
70927059|NCT03858634|141348557|SUPERIORITY||LS mean difference|-55.1|STANDARD_ERROR_OF_MEAN|51.61||0.3978|TWO_SIDED|80.0|-152.39|42.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||42.26|-152.39|0.3978
70927060|NCT03858634|141348557|SUPERIORITY||LS mean difference|-32.7|STANDARD_ERROR_OF_MEAN|14.73||0.0397|TWO_SIDED|80.0|-52.26|-13.07||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-13.07|-52.26|0.0397
70927061|NCT03858634|141348557|SUPERIORITY||LS mean difference|10.4|STANDARD_ERROR_OF_MEAN|70.66||0.8922|TWO_SIDED|80.0|-105.32|126.14||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||126.14|-105.32|0.8922
71009944|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|-0.17|STANDARD_ERROR_OF_MEAN|3.28|||TWO_SIDED|95.0|-6.97|6.64|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||6.64|-6.97|
70927062|NCT03858634|141348557|SUPERIORITY||LS mean difference|17.3|STANDARD_ERROR_OF_MEAN|14.43||0.2439|TWO_SIDED|80.0|-1.8|36.45||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||36.45|-1.80|0.2439
70927063|NCT03858634|141348557|SUPERIORITY||LS mean difference|-50.3|STANDARD_ERROR_OF_MEAN|37.1||0.3076|TWO_SIDED|80.0|-120.29|19.61||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||19.61|-120.29|0.3076
70927064|NCT03858634|141348557|SUPERIORITY||LS mean difference|-36.4|STANDARD_ERROR_OF_MEAN|15.7||0.0322|TWO_SIDED|80.0|-57.32|-15.55||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-15.55|-57.32|0.0322
71103469|NCT00863304|141714821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.22||0.001|TWO_SIDED|95.0|-1.12|-0.27||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.27|-1.12|0.001
70927065|NCT03858634|141348557|SUPERIORITY||LS mean difference|-94.7|STANDARD_ERROR_OF_MEAN|27.67||0.0418|TWO_SIDED|80.0|-139.98|-49.36||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||-49.36|-139.98|0.0418
70927066|NCT03858634|141348557|SUPERIORITY||LS mean difference|24.4|STANDARD_ERROR_OF_MEAN|13.44||0.0865|TWO_SIDED|80.0|6.49|42.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||42.26|6.49|0.0865
70927067|NCT03858634|141348557|SUPERIORITY||LS mean difference|-48.9|STANDARD_ERROR_OF_MEAN|40.32||0.3489|TWO_SIDED|80.0|-124.96|27.11||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||27.11|-124.96|0.3489
70927068|NCT03858634|141348557|SUPERIORITY||LS mean difference|-38.1|STANDARD_ERROR_OF_MEAN|15.99||0.0286|TWO_SIDED|80.0|-59.34|-16.79||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||-16.79|-59.34|0.0286
70927069|NCT03858634|141348557|SUPERIORITY||LS mean difference|28.6|STANDARD_ERROR_OF_MEAN|72.63||0.7198|TWO_SIDED|80.0|-90.32|147.59||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||147.59|-90.32|0.7198
70927070|NCT03858634|141348557|SUPERIORITY||LS mean difference|39.0|STANDARD_ERROR_OF_MEAN|13.27||0.0088|TWO_SIDED|80.0|21.32|56.63||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||56.63|21.32|0.0088
70927071|NCT03858634|141348557|SUPERIORITY||LS mean difference|-56.5|STANDARD_ERROR_OF_MEAN|33.87||0.2371|TWO_SIDED|80.0|-120.39|7.34||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||7.34|-120.39|0.2371
71103470|NCT00863304|141714821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.22||0.003|TWO_SIDED|95.0|-1.09|-0.23||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.23|-1.09|0.003
71103471|NCT00863304|141714821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|-1.25|-0.39||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.39|-1.25|<0.001
70927072|NCT03858634|141348557|SUPERIORITY||LS mean difference|-40.8|STANDARD_ERROR_OF_MEAN|16.14||0.021|TWO_SIDED|80.0|-62.3|-19.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-19.35|-62.30|0.0210
70927073|NCT03858634|141348557|SUPERIORITY||LS mean difference|20.4|STANDARD_ERROR_OF_MEAN|54.07||0.7312|TWO_SIDED|80.0|-68.17|108.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||108.94|-68.17|0.7312
70927074|NCT03858634|141348557|SUPERIORITY||LS mean difference|39.4|STANDARD_ERROR_OF_MEAN|14.64||0.015|TWO_SIDED|80.0|19.88|58.83||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||58.83|19.88|0.0150
71009945|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|-7.74|STANDARD_ERROR_OF_MEAN|3.51|||TWO_SIDED|95.0|-15.03|-0.44|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||-0.44|-15.03|
71009946|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|-3.86|STANDARD_ERROR_OF_MEAN|3.37|||TWO_SIDED|95.0|-10.88|3.16|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||3.16|-10.88|
71009947|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|-9.53|STANDARD_ERROR_OF_MEAN|3.16|||TWO_SIDED|95.0|-16.1|-2.95|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8||-2.95|-16.10|
71009948|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|-5.66|STANDARD_ERROR_OF_MEAN|2.96|||TWO_SIDED|95.0|-11.82|0.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||0.50|-11.82|
71009949|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|-8.62|STANDARD_ERROR_OF_MEAN|4.4|||TWO_SIDED|95.0|-17.77|0.54|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||0.54|-17.77|
71009950|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|-6.05|STANDARD_ERROR_OF_MEAN|4.2|||TWO_SIDED|95.0|-14.79|2.69|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||2.69|-14.79|
70927075|NCT03858634|141348557|SUPERIORITY||LS mean difference|-53.3|STANDARD_ERROR_OF_MEAN|33.87||0.2559|TWO_SIDED|80.0|-117.22|10.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||10.52|-117.22|0.2559
70927076|NCT03858634|141348557|SUPERIORITY||LS mean difference|-35.0|STANDARD_ERROR_OF_MEAN|15.97||0.0419|TWO_SIDED|80.0|-56.21|-13.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||-13.72|-56.21|0.0419
70927077|NCT03858634|141348557|SUPERIORITY||LS mean difference|20.4|STANDARD_ERROR_OF_MEAN|60.66||0.7589|TWO_SIDED|80.0|-78.95|119.74||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||119.74|-78.95|0.7589
70927078|NCT03858634|141348557|SUPERIORITY||LS mean difference|39.1|STANDARD_ERROR_OF_MEAN|17.42||0.0374|TWO_SIDED|80.0|15.97|62.31||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||62.31|15.97|0.0374
70927079|NCT03858634|141348557|SUPERIORITY||LS mean difference|-54.9|STANDARD_ERROR_OF_MEAN|33.87||0.2463|TWO_SIDED|80.0|-118.8|8.93||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||8.93|-118.80|0.2463
70927080|NCT03858634|141348557|SUPERIORITY||LS mean difference|-33.2|STANDARD_ERROR_OF_MEAN|16.78||0.0632|TWO_SIDED|80.0|-55.56|-10.9||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-10.90|-55.56|0.0632
70927081|NCT03858634|141348557|SUPERIORITY||LS mean difference|25.7|STANDARD_ERROR_OF_MEAN|61.73||0.7053|TWO_SIDED|80.0|-75.41|126.78||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||126.78|-75.41|0.7053
70927082|NCT03858634|141348557|SUPERIORITY||LS mean difference|38.7|STANDARD_ERROR_OF_MEAN|16.25||0.0285|TWO_SIDED|80.0|17.09|60.34||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||60.34|17.09|0.0285
70927083|NCT03858634|141348557|SUPERIORITY||LS mean difference|-64.6|STANDARD_ERROR_OF_MEAN|37.1||0.2236|TWO_SIDED|80.0|-134.58|5.32||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||5.32|-134.58|0.2236
70927084|NCT03858634|141348557|OTHER||LS mean difference|-35.5|STANDARD_ERROR_OF_MEAN|17.38||0.0558|TWO_SIDED|80.0|-58.65|-12.41||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||-12.41|-58.65|0.0558
71009951|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|-1.36|STANDARD_ERROR_OF_MEAN|4.4|||TWO_SIDED|95.0|-10.51|7.79|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||7.79|-10.51|
71009952|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|-4.95|STANDARD_ERROR_OF_MEAN|4.11|||TWO_SIDED|95.0|-13.5|3.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||3.60|-13.50|
71009953|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|-3.43|STANDARD_ERROR_OF_MEAN|3.55|||TWO_SIDED|95.0|-10.81|3.96|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||3.96|-10.81|
71009954|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|-5.38|STANDARD_ERROR_OF_MEAN|3.49|||TWO_SIDED|95.0|-12.64|1.89|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||1.89|-12.64|
70927085|NCT03858634|141348557|SUPERIORITY||LS mean difference|29.9|STANDARD_ERROR_OF_MEAN|72.86||0.7089|TWO_SIDED|80.0|-89.41|149.24||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||149.24|-89.41|0.7089
70927086|NCT03858634|141348557|SUPERIORITY||LS mean difference|33.7|STANDARD_ERROR_OF_MEAN|14.76||0.0347|TWO_SIDED|80.0|14.08|53.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||53.35|14.08|0.0347
70927087|NCT03858634|141348557|SUPERIORITY||LS mean difference|-60.9|STANDARD_ERROR_OF_MEAN|41.94||0.2835|TWO_SIDED|80.0|-139.99|18.16||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||18.16|-139.99|0.2835
71009955|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|-0.08|STANDARD_ERROR_OF_MEAN|3.59|||TWO_SIDED|95.0|-7.55|7.39|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||7.39|-7.55|
71046226|NCT02312713|141600653|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|1.48||||0.11|TWO_SIDED|95.0|-0.33|3.29|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||3.29|-0.33|0.11
70927088|NCT03858634|141348557|SUPERIORITY||LS mean difference|-35.5|STANDARD_ERROR_OF_MEAN|17.11||0.0525|TWO_SIDED|80.0|-58.31|-12.77||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-12.77|-58.31|0.0525
71009956|NCT03091920|141526972|OTHER|No statistical testing was performed.|Least squares mean difference|-1.89|STANDARD_ERROR_OF_MEAN|3.37|||TWO_SIDED|95.0|-8.89|5.12|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||5.12|-8.89|
71009957|NCT03091920|141526973|OTHER|No statistical testing was performed.|Least squares mean difference|-0.79|STANDARD_ERROR_OF_MEAN|1.63|||TWO_SIDED|95.0|-4.17|2.59|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||2.59|-4.17|
71009958|NCT03091920|141526973|OTHER|No statistical testing was performed.|Least squares mean difference|-1.09|STANDARD_ERROR_OF_MEAN|1.63|||TWO_SIDED|95.0|-4.47|2.29|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||2.29|-4.47|
71009959|NCT03091920|141526973|OTHER|No statistical testing was performed.|Least squares mean difference|-0.94|STANDARD_ERROR_OF_MEAN|1.48|||TWO_SIDED|95.0|-4.02|2.14|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1||2.14|-4.02|
71009960|NCT03091920|141526973|OTHER|No statistical testing was performed.|Least squares mean difference|-2.67|STANDARD_ERROR_OF_MEAN|1.89|||TWO_SIDED|95.0|-6.6|1.26|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||1.26|-6.60|
71009961|NCT03091920|141526973|OTHER|No statistical testing was performed.|Least squares mean difference|-1.84|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|95.0|-5.77|2.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||2.10|-5.77|
71009962|NCT03091920|141526973|OTHER|No statistical testing was performed.|Least squares mean difference|-2.25|STANDARD_ERROR_OF_MEAN|1.72|||TWO_SIDED|95.0|-5.83|1.32|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 7||1.32|-5.83|
71009963|NCT03091920|141526973|OTHER|No statistical testing was performed.|Least squares mean difference|-3.97|STANDARD_ERROR_OF_MEAN|2.66|||TWO_SIDED|95.0|-9.5|1.56|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||1.56|-9.50|
71009964|NCT03091920|141526973|OTHER|No statistical testing was performed.|Least squares mean difference|-4.17|STANDARD_ERROR_OF_MEAN|2.57|||TWO_SIDED|95.0|-9.52|1.18|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||1.18|-9.52|
71009965|NCT03091920|141526973|OTHER|No statistical testing was performed.|Least squares mean difference|-4.07|STANDARD_ERROR_OF_MEAN|2.38|||TWO_SIDED|95.0|-9.01|0.87|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 14||0.87|-9.01|
71009966|NCT03091920|141526974|OTHER|No statistical testing was performed.|Least squares mean difference|-3.4|STANDARD_ERROR_OF_MEAN|2.22|||TWO_SIDED|95.0|-8.01|1.21|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||1.21|-8.01|
71009967|NCT03091920|141526974|OTHER|No statistical testing was performed.|Least squares mean difference|-3.6|STANDARD_ERROR_OF_MEAN|2.23|||TWO_SIDED|95.0|-8.21|1.02|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||1.02|-8.21|
71009968|NCT03091920|141526974|OTHER|No statistical testing was performed.|Least squares mean difference|-3.3|STANDARD_ERROR_OF_MEAN|2.04|||TWO_SIDED|95.0|-7.53|0.92|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||0.92|-7.53|
71009969|NCT03091920|141526974|OTHER|No statistical testing was performed.|Least squares mean difference|-2.01|STANDARD_ERROR_OF_MEAN|2.04|||TWO_SIDED|95.0|-6.24|2.23|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||2.23|-6.24|
71009970|NCT03091920|141526974|OTHER|No statistical testing was performed.|Least squares mean difference|-7.29|STANDARD_ERROR_OF_MEAN|2.65|||TWO_SIDED|95.0|-12.8|-1.79|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||-1.79|-12.80|
71103472|NCT00863304|141714821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.22||0.572|TWO_SIDED|95.0|-0.31|0.55||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.55|-0.31|0.572
71009971|NCT03091920|141526974|OTHER|No statistical testing was performed.|Least squares mean difference|-5.1|STANDARD_ERROR_OF_MEAN|2.56|||TWO_SIDED|95.0|-10.43|0.23|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||0.23|-10.43|
71009972|NCT03091920|141526975|OTHER|No statistical testing was performed.|Least squares mean difference|0.99|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|-2.97|4.95|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||4.95|-2.97|
71009973|NCT03091920|141526975|OTHER|No statistical testing was performed.|Least squares mean difference|0.55|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|-3.41|4.52|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||4.52|-3.41|
71009974|NCT03091920|141526975|OTHER|No statistical testing was performed.|Least squares mean difference|-2.54|STANDARD_ERROR_OF_MEAN|2.46|||TWO_SIDED|95.0|-7.63|2.56|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||2.56|-7.63|
71009975|NCT03091920|141526975|OTHER|No statistical testing was performed.|Least squares mean difference|-2.26|STANDARD_ERROR_OF_MEAN|2.46|||TWO_SIDED|95.0|-7.36|2.85|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||2.85|-7.36|
71009976|NCT03091920|141526975|OTHER|No statistical testing was performed.|Least squares mean difference|-1.03|STANDARD_ERROR_OF_MEAN|3.13|||TWO_SIDED|95.0|-7.55|5.49|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||5.49|-7.55|
71009977|NCT03091920|141526975|OTHER|No statistical testing was performed.|Least squares mean difference|-3.68|STANDARD_ERROR_OF_MEAN|3.04|||TWO_SIDED|95.0|-10.0|2.65|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||2.65|-10.00|
71046227|NCT02312713|141600653|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.79||||0.33|TWO_SIDED|95.0|-0.8|2.37|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||2.37|-0.8|0.33
71009978|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|-2.58|STANDARD_ERROR_OF_MEAN|2.49|||TWO_SIDED|95.0|-7.76|2.59|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||2.59|-7.76|
71009979|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|-4.06|STANDARD_ERROR_OF_MEAN|2.53|||TWO_SIDED|95.0|-9.32|1.19|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||1.19|-9.32|
71009980|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|-3.86|STANDARD_ERROR_OF_MEAN|2.73|||TWO_SIDED|95.0|-9.51|1.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||1.80|-9.51|
71009981|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|-4.73|STANDARD_ERROR_OF_MEAN|2.73|||TWO_SIDED|95.0|-10.4|0.93|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||0.93|-10.40|
71009982|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|-5.1|STANDARD_ERROR_OF_MEAN|3.36|||TWO_SIDED|95.0|-12.06|1.86|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||1.86|-12.06|
71009983|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|-2.96|STANDARD_ERROR_OF_MEAN|3.33|||TWO_SIDED|95.0|-9.87|3.96|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||3.96|-9.87|
71009984|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|0.87|STANDARD_ERROR_OF_MEAN|2.69|||TWO_SIDED|95.0|-4.7|6.45|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||6.45|-4.70|
71009985|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|0.55|STANDARD_ERROR_OF_MEAN|2.63|||TWO_SIDED|95.0|-4.9|6.01|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||6.01|-4.90|
71009986|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|-0.56|STANDARD_ERROR_OF_MEAN|3.21|||TWO_SIDED|95.0|-7.22|6.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||6.10|-7.22|
71009987|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|-0.47|STANDARD_ERROR_OF_MEAN|3.28|||TWO_SIDED|95.0|-7.27|6.34|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||6.34|-7.27|
71009988|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|1.72|STANDARD_ERROR_OF_MEAN|2.4|||TWO_SIDED|95.0|-3.26|6.69|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||6.69|-3.26|
71009989|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|0.25|STANDARD_ERROR_OF_MEAN|2.38|||TWO_SIDED|95.0|-4.69|5.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||5.20|-4.69|
71046228|NCT02312713|141600654|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.06|TWO_SIDED|95.0|-1.62|0.04|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||0.04|-1.62|0.06
70927089|NCT03858634|141348557|SUPERIORITY||LS mean difference|24.0|STANDARD_ERROR_OF_MEAN|64.52||0.7347|TWO_SIDED|80.0|-81.68|129.66||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||129.66|-81.68|0.7347
70927090|NCT03858634|141348557|SUPERIORITY||LS mean difference|31.0|STANDARD_ERROR_OF_MEAN|13.94||0.039|TWO_SIDED|80.0|12.5|49.6||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||49.60|12.50|0.0390
70927091|NCT03858634|141348557|SUPERIORITY||LS mean difference|-60.6|STANDARD_ERROR_OF_MEAN|35.48||0.2299|TWO_SIDED|80.0|-127.49|6.33||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||6.33|-127.49|0.2299
70927092|NCT03858634|141348557|SUPERIORITY||LS mean difference|-32.6|STANDARD_ERROR_OF_MEAN|18.11||0.0884|TWO_SIDED|80.0|-56.7|-8.53||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||-8.53|-56.70|0.0884
70927093|NCT03858634|141348557|SUPERIORITY||LS mean difference|16.3|STANDARD_ERROR_OF_MEAN|61.44||0.8085|TWO_SIDED|80.0|-84.37|116.87||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||116.87|-84.37|0.8085
70927094|NCT03858634|141348557|SUPERIORITY||LS mean difference|19.9|STANDARD_ERROR_OF_MEAN|15.96||0.2283|TWO_SIDED|80.0|-1.33|41.14||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||41.14|-1.33|0.2283
70927095|NCT03858634|141348557|SUPERIORITY||LS mean difference|-69.9|STANDARD_ERROR_OF_MEAN|32.26||0.1625|TWO_SIDED|80.0|-130.76|-9.11||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-9.11|-130.76|0.1625
70927096|NCT03858634|141348557|SUPERIORITY||LS mean difference|-34.2|STANDARD_ERROR_OF_MEAN|17.8||0.0707|TWO_SIDED|80.0|-57.87|-10.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-10.52|-57.87|0.0707
70927097|NCT03858634|141348557|SUPERIORITY||LS mean difference|0.4|STANDARD_ERROR_OF_MEAN|50.17||0.9944|TWO_SIDED|80.0|-81.79|82.55||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||82.55|-81.79|0.9944
71009990|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|-4.43|STANDARD_ERROR_OF_MEAN|1.96|||TWO_SIDED|95.0|-8.5|-0.36|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||-0.36|-8.50|
70927098|NCT03858634|141348557|SUPERIORITY||LS mean difference|23.9|STANDARD_ERROR_OF_MEAN|15.16||0.1327|TWO_SIDED|80.0|3.71|44.05||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||44.05|3.71|0.1327
70927099|NCT03858634|141348557|SUPERIORITY||LS mean difference|-69.2|STANDARD_ERROR_OF_MEAN|33.87||0.1777|TWO_SIDED|80.0|-133.09|-5.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||-5.35|-133.09|0.1777
70927100|NCT03858634|141348557|SUPERIORITY||LS mean difference|-23.9|STANDARD_ERROR_OF_MEAN|21.4||0.2796|TWO_SIDED|80.0|-52.34|4.61||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||4.61|-52.34|0.2796
70927101|NCT03858634|141348557|SUPERIORITY||LS mean difference|7.6|STANDARD_ERROR_OF_MEAN|55.4||0.8999|TWO_SIDED|80.0|-83.15|98.3||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||98.30|-83.15|0.8999
70927102|NCT03858634|141348557|SUPERIORITY||LS mean difference|22.0|STANDARD_ERROR_OF_MEAN|15.99||0.1867|TWO_SIDED|80.0|0.68|43.23||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||43.23|0.68|0.1867
70927103|NCT03858634|141348557|SUPERIORITY||LS mean difference|-70.8|STANDARD_ERROR_OF_MEAN|33.87||0.1717|TWO_SIDED|80.0|-134.68|-6.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-6.94|-134.68|0.1717
71009991|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|-4.17|STANDARD_ERROR_OF_MEAN|1.99|||TWO_SIDED|95.0|-8.3|-0.03|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||-0.03|-8.30|
70927104|NCT03858634|141348557|SUPERIORITY||LS mean difference|-23.9|STANDARD_ERROR_OF_MEAN|21.46||0.2792|TWO_SIDED|80.0|-52.5|4.61||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||4.61|-52.50|0.2792
70927105|NCT03858634|141348559|SUPERIORITY||LS Mean Difference|-47.3|STANDARD_ERROR_OF_MEAN|31.41||0.2289|TWO_SIDED|80.0|-98.77|4.1||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||4.10|-98.77|0.2289
70927106|NCT03858634|141348559|SUPERIORITY||LS Mean Difference|19.6|STANDARD_ERROR_OF_MEAN|14.08||0.1788|TWO_SIDED|80.0|0.96|38.27||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||38.27|0.96|0.1788
70927107|NCT03858634|141348559|SUPERIORITY||LS Mean Difference|-59.6|STANDARD_ERROR_OF_MEAN|114.35||0.6544|TWO_SIDED|80.0|-275.19|156.06||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||156.06|-275.19|0.6544
70927108|NCT03858634|141348559|SUPERIORITY||LS Mean Difference|-72.2|STANDARD_ERROR_OF_MEAN|20.4||0.0023|TWO_SIDED|80.0|-99.39|-45.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-45.09|-99.39|0.0023
70927109|NCT03858634|141348559|SUPERIORITY||LS Mean Difference|-52.1|STANDARD_ERROR_OF_MEAN|22.96||0.1081|TWO_SIDED|80.0|-89.68|-14.47||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-14.47|-89.68|0.1081
70927110|NCT03858634|141348559|SUPERIORITY||LS Mean Difference|14.9|STANDARD_ERROR_OF_MEAN|21.37||0.4926|TWO_SIDED|80.0|-13.39|43.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||43.26|-13.39|0.4926
71009992|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|-3.39|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-9.82|3.04|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||3.04|-9.82|
70927111|NCT03858634|141348559|SUPERIORITY||LS Mean Difference|53.2|STANDARD_ERROR_OF_MEAN|219.98||0.8315|TWO_SIDED|80.0|-361.63|467.98||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||467.98|-361.63|0.8315
70927112|NCT03858634|141348559|SUPERIORITY||LS Mean Difference|-69.9|STANDARD_ERROR_OF_MEAN|18.56||0.0014|TWO_SIDED|80.0|-94.61|-45.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-45.22|-94.61|0.0014
70927113|NCT03858634|141348559|SUPERIORITY||LS Mean Difference|-52.1|STANDARD_ERROR_OF_MEAN|22.96||0.1081|TWO_SIDED|80.0|-89.68|-14.47||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-14.47|-89.68|0.1081
70927114|NCT03858634|141348559|SUPERIORITY||LS Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|21.97||0.7339|TWO_SIDED|80.0|-21.65|36.82||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||36.82|-21.65|0.7339
70927115|NCT03858634|141348559|SUPERIORITY||LS Mean Difference|53.2|STANDARD_ERROR_OF_MEAN|219.98||0.8315|TWO_SIDED|80.0|-361.63|467.98||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||467.98|-361.63|0.8315
70927116|NCT03858634|141348559|SUPERIORITY||LS Mean Difference|-67.6|STANDARD_ERROR_OF_MEAN|21.26||0.0055|TWO_SIDED|80.0|-95.92|-39.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-39.22|-95.92|0.0055
70927117|NCT03858634|141348559|SUPERIORITY||LS Mean Difference|-57.9|STANDARD_ERROR_OF_MEAN|26.73||0.1188|TWO_SIDED|80.0|-101.7|-14.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-14.15|-101.70|0.1188
70927118|NCT03858634|141348559|SUPERIORITY||LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|18.27||0.8697|TWO_SIDED|80.0|-21.26|27.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||27.35|-21.26|0.8697
71009993|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|-1.06|STANDARD_ERROR_OF_MEAN|3.11|||TWO_SIDED|95.0|-7.51|5.38|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||5.38|-7.51|
70927119|NCT03858634|141348559|SUPERIORITY||LS Mean Difference|-30.3|STANDARD_ERROR_OF_MEAN|78.64||0.7368|TWO_SIDED|80.0|-178.62|117.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||117.94|-178.62|0.7368
70927120|NCT03858634|141348559|SUPERIORITY||LS Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|15.02||0.5571|TWO_SIDED|80.0|-29.03|11.03||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||11.03|-29.03|0.5571
70927121|NCT03858634|141348559|SUPERIORITY||LS Mean Difference|-49.1|STANDARD_ERROR_OF_MEAN|32.21||0.2251|TWO_SIDED|80.0|-101.8|3.69||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||3.69|-101.80|0.2251
70927122|NCT03858634|141348559|SUPERIORITY||LS Mean Difference|17.3|STANDARD_ERROR_OF_MEAN|18.93||0.3733|TWO_SIDED|80.0|-7.9|42.48||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||42.48|-7.90|0.3733
70927123|NCT03858634|141348559|SUPERIORITY||LS Mean Difference|-22.6|STANDARD_ERROR_OF_MEAN|66.57||0.7662|TWO_SIDED|80.0|-148.16|102.89||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||102.89|-148.16|0.7662
70927124|NCT03858634|141348559|OTHER||LS Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|16.87||0.7241|TWO_SIDED|80.0|-28.54|16.44||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||16.44|-28.54|0.7241
71009994|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|-2.82|STANDARD_ERROR_OF_MEAN|2.56|||TWO_SIDED|95.0|-8.12|2.48|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||2.48|-8.12|
70927125|NCT03858634|141348561|SUPERIORITY||LS Mean Difference|-21.1|STANDARD_ERROR_OF_MEAN|29.04||0.5195|TWO_SIDED|80.0|-68.69|26.43||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||26.43|-68.69|0.5195
70927126|NCT03858634|141348561|SUPERIORITY||LS Mean Difference|11.3|STANDARD_ERROR_OF_MEAN|8.27||0.1869|TWO_SIDED|80.0|0.34|22.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||22.26|0.34|0.1869
70927127|NCT03858634|141348561|SUPERIORITY||LS Mean Difference|-87.5|STANDARD_ERROR_OF_MEAN|55.3||0.2545|TWO_SIDED|80.0|-191.75|16.79||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||16.79|-191.75|0.2545
70927128|NCT03858634|141348561|SUPERIORITY||LS Mean Difference|-20.2|STANDARD_ERROR_OF_MEAN|10.26||0.0643|TWO_SIDED|80.0|-33.88|-6.57||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-6.57|-33.88|0.0643
70927129|NCT03858634|141348561|SUPERIORITY||LS Mean Difference|-28.6|STANDARD_ERROR_OF_MEAN|20.11||0.2503|TWO_SIDED|80.0|-61.52|4.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||4.35|-61.52|0.2503
70927130|NCT03858634|141348561|SUPERIORITY||LS Mean Difference|2.3|STANDARD_ERROR_OF_MEAN|11.58||0.8468|TWO_SIDED|80.0|-13.08|17.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||17.62|-13.08|0.8468
70927131|NCT03858634|141348561|SUPERIORITY||LS Mean Difference|-83.6|STANDARD_ERROR_OF_MEAN|73.93||0.3755|TWO_SIDED|80.0|-222.98|55.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||55.18|-222.98|0.3755
70927132|NCT03858634|141348561|SUPERIORITY||LS Mean Difference|-20.9|STANDARD_ERROR_OF_MEAN|11.06||0.0755|TWO_SIDED|80.0|-35.58|-6.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-6.15|-35.58|0.0755
71009995|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|-1.36|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|95.0|-6.63|3.91|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||3.91|-6.63|
70927133|NCT03858634|141348561|SUPERIORITY||LS Mean Difference|-28.6|STANDARD_ERROR_OF_MEAN|25.77||0.3486|TWO_SIDED|80.0|-70.76|13.65||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||13.65|-70.76|0.3486
70927134|NCT03858634|141348561|SUPERIORITY||LS Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|9.69||0.6559|TWO_SIDED|80.0|-17.28|8.5||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||8.50|-17.28|0.6559
70927135|NCT03858634|141348561|SUPERIORITY||LS Mean Difference|-70.2|STANDARD_ERROR_OF_MEAN|50.46||0.2987|TWO_SIDED|80.0|-165.35|24.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||24.94|-165.35|0.2987
70927136|NCT03858634|141348561|SUPERIORITY||LS Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|12.43||0.1966|TWO_SIDED|80.0|-33.29|-0.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-0.13|-33.29|0.1966
70927137|NCT03858634|141348561|SUPERIORITY||LS Mean Difference|-41.5|STANDARD_ERROR_OF_MEAN|25.7||0.2051|TWO_SIDED|80.0|-83.56|0.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||0.62|-83.56|0.2051
70927138|NCT03858634|141348561|SUPERIORITY||LS Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|10.16||0.7511|TWO_SIDED|80.0|-16.79|10.25||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||10.25|-16.79|0.7511
70927139|NCT03858634|141348561|SUPERIORITY||LS Mean Difference|-79.6|STANDARD_DEVIATION|39.27||0.1797|TWO_SIDED|80.0|-153.68|-5.59||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-5.59|-153.68|0.1797
70927140|NCT03858634|141348561|SUPERIORITY||LS Mean Difference|-16.3|STANDARD_ERROR_OF_MEAN|11.45||0.1715|TWO_SIDED|80.0|-31.61|-1.08||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-1.08|-31.61|0.1715
71009996|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|-1.19|STANDARD_ERROR_OF_MEAN|2.97|||TWO_SIDED|95.0|-7.35|4.97|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||4.97|-7.35|
70927141|NCT03858634|141348561|SUPERIORITY||LS Mean Difference|-36.5|STANDARD_ERROR_OF_MEAN|21.32||0.185|TWO_SIDED|80.0|-71.47|-1.63||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-1.63|-71.47|0.1850
70927142|NCT03858634|141348561|SUPERIORITY||LS Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|12.19||0.6907|TWO_SIDED|80.0|-21.15|11.29||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||11.29|-21.15|0.6907
70927143|NCT03858634|141348561|SUPERIORITY||LS Mean Difference|-74.0|STANDARD_ERROR_OF_MEAN|23.85||0.0901|TWO_SIDED|80.0|-118.97|-29.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-29.02|-118.97|0.0901
70927144|NCT03858634|141348561|SUPERIORITY||LS Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|13.34||0.564|TWO_SIDED|80.0|-25.64|9.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||9.94|-25.64|0.5640
70927145|NCT03858634|141348562|SUPERIORITY||LS mean difference|-31.7|STANDARD_ERROR_OF_MEAN|38.73||0.4734|TWO_SIDED|80.0|-95.11|31.76||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||31.76|-95.11|0.4734
71009997|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|-1.26|STANDARD_ERROR_OF_MEAN|2.91|||TWO_SIDED|95.0|-7.3|4.77|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||4.77|-7.30|
71009998|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|-5.86|STANDARD_ERROR_OF_MEAN|3.29|||TWO_SIDED|95.0|-12.68|0.95|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||0.95|-12.68|
70927146|NCT03858634|141348562|SUPERIORITY||LS mean difference|-3.6|STANDARD_ERROR_OF_MEAN|14.91||0.813|TWO_SIDED|80.0|-23.33|16.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||16.18|-23.33|0.8130
70927147|NCT03858634|141348562|SUPERIORITY||LS mean difference|-92.0|STANDARD_ERROR_OF_MEAN|31.1||0.0979|TWO_SIDED|80.0|-150.6|-33.32||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||-33.32|-150.60|0.0979
70927148|NCT03858634|141348562|SUPERIORITY||LS mean difference|-37.5|STANDARD_ERROR_OF_MEAN|13.48||0.0122|TWO_SIDED|80.0|-55.48|-19.61||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||-19.61|-55.48|0.0122
70927149|NCT03848065|141348661|OTHER||Difference in Percentages|17.8||||0.004|TWO_SIDED|95.0|9.0|31.4|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Injection Site Erythema (Redness)||31.4|9.0|0.004
70927150|NCT03848065|141348661|OTHER||Difference in Percentages|4.7||||0.15|TWO_SIDED|95.0|-3.7|15.5|||Miettinen & Nurminen method||Difference = % V114-SC minus % PCV13-SC|Injection Site Erythema (Redness)||15.5|-3.7|0.150
70927151|NCT03848065|141348661|OTHER||Difference in Percentages|-13.1||||0.054|TWO_SIDED|95.0|-27.6|0.2|||Miettinen & Nurminen method||Difference = % V114-IM minus % PCV13-SC|Injection Site Erythema (Redness)||0.2|-27.6|0.054
70927152|NCT03848065|141348661|OTHER||Difference in Percentages|13.1||||0.091|TWO_SIDED|95.0|-2.3|28.8|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Injection Site Induration (Hard Lump)||28.8|-2.3|0.091
70927153|NCT03848065|141348661|OTHER||Difference in Percentages|-9.1||||0.044|TWO_SIDED|95.0|-21.2|-0.4|||Miettinen & Nurminen method||Difference = % V114-SC minus % PCV13-SC|Injection Site Induration (Hard Lump)||-0.4|-21.2|0.044
70927154|NCT03848065|141348661|OTHER||Difference in Percentages|-22.2||||0.001|TWO_SIDED|95.0|-36.4|-12.5|||Miettinen & Nurminen method||Difference = % V114-IM minus % PCV13-SC|Injection Site Induration (Hard Lump)||-12.5|-36.4|0.001
70927155|NCT03848065|141348661|OTHER||Difference in Percentages|9.7||||0.333|TWO_SIDED|95.0|-10.0|28.9|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Injection Site Pain||28.9|-10.0|0.333
70927156|NCT03848065|141348661|OTHER||Difference in Percentages|-3.2||||0.76|TWO_SIDED|95.0|-23.4|17.2|||Miettinen & Nurminen method||Difference = % V114-SC minus % PCV13-SC|Injection Site Pain||17.2|-23.4|0.760
70927157|NCT03848065|141348661|OTHER||Difference in Percentages|-13.0||||0.205|TWO_SIDED|95.0|-32.2|7.1|||Miettinen & Nurminen method||Difference = % V114-IM minus % PCV13-SC|Injection Site Pain||7.1|-32.2|0.205
70927158|NCT03848065|141348661|OTHER||Difference in Percentages|13.0||||0.128|TWO_SIDED|95.0|-3.9|29.7|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Injection Site Swelling||29.7|-3.9|0.128
70927159|NCT03848065|141348661|OTHER||Difference in Percentages|-2.0||||0.779|TWO_SIDED|95.0|-17.0|13.0|||Miettinen & Nurminen method||Difference = % V114-SC minus % PCV13-SC|Injection Site Swelling||13.0|-17.0|0.779
70927160|NCT03848065|141348661|OTHER||Difference in Parentages|-15.0||||0.076|TWO_SIDED|95.0|-31.5|1.7|||Miettinen & Nurminen method||Difference = % V114-IM minus % PCV13-SC|Injection Site Swelling||1.7|-31.5|0.076
70927161|NCT03848065|141348662|OTHER||Difference in Percentages|-10.6||||0.282|TWO_SIDED|95.0|-29.1|8.7|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Decreased Appetite (Appetite Loss)||8.7|-29.1|0.282
70927162|NCT03848065|141348662|OTHER||Difference in Percentages|-9.9||||0.317|TWO_SIDED|95.0|-28.7|9.5|||Miettinen & Nurminen method||Difference= % V114-SC minus % PCV13-SC|Decreased Appetite (Appetite Loss)||9.5|-28.7|0.317
70927163|NCT03848065|141348662|OTHER||Difference in Percentages|0.7||||0.948|TWO_SIDED|95.0|-19.2|20.4|||Miettinen & Nurminen method||Difference= % V114-IM minus % PCV13-SC|Decreased Appetite (Appetite Loss)||20.4|-19.2|0.948
70927164|NCT03848065|141348662|OTHER||Difference in Percentages|10.5||||0.303|TWO_SIDED|95.0|-9.4|29.6|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Somnolence (Drowsiness)||29.6|-9.4|0.303
70927165|NCT03848065|141348662|OTHER||Difference in Percentages|-4.0||||0.681|TWO_SIDED|95.0|-22.6|15.0|||Miettinen & Nurminen method||Difference= % V114-SC minus % PCV13-SC|Somnolence (Drowsiness)||15.0|-22.6|0.681
70927166|NCT03848065|141348662|OTHER||Difference in Percentages|-14.4||||0.153|TWO_SIDED|95.0|-33.2|5.4|||Miettinen & Nurminen method||Difference= % V114-IM minus % PCV13-SC|Somnolence (Drowsiness)||5.4|-33.2|0.153
70927167|NCT03848065|141348662|OTHER||Difference in Percentages|10.7||||0.237|TWO_SIDED|95.0|-7.2|28.2|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Irritability||28.2|-7.2|0.237
70927168|NCT03848065|141348662|OTHER||Difference in Percentages|7.4||||0.406|TWO_SIDED|95.0|-10.3|25.0|||Miettinen & Nurminen method||Difference= % V114-SC minus % PCV13-SC|Irritability||25.0|-10.3|0.406
70927169|NCT03848065|141348662|OTHER||Difference in Percentages|-3.3||||0.729|TWO_SIDED|95.0|-21.8|15.5|||Miettinen & Nurminen method||Difference= % V114-IM minus % PCV13-SC|Irritability||15.5|-21.8|0.729
70927170|NCT03848065|141348662|OTHER||Difference in Percentages|4.6||||0.385|TWO_SIDED|95.0|-7.1|17.5|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Urticaria (Hives/Welts)||17.5|-7.1|0.385
70927171|NCT03848065|141348662|OTHER||Difference in Percentages|2.1||||0.719|TWO_SIDED|95.0|-11.0|15.4|||Miettinen & Nurminen method||Difference= % V114-SC minus % PCV13-SC|Urticaria (Hives/Welts)||15.4|-11.0|0.719
70927172|NCT03848065|141348662|OTHER||Difference in Percentages|-2.5||||0.61|TWO_SIDED|95.0|-14.9|8.9|||Miettinen & Nurminen method||Difference= % V114-IM minus % PCV13-SC|Urticaria (Hives/Welts)||8.9|-14.9|0.610
70927173|NCT03848065|141348664|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 1||8.5|-8.1|
70927174|NCT03848065|141348664|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 1||8.5|-7.9|
70927175|NCT03848065|141348664|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 1||7.9|-8.1|
70927176|NCT03848065|141348664|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114- SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 3||8.5|-8.1|
70927177|NCT03848065|141348664|OTHER||Difference in Percentages|-2.2|||||TWO_SIDED|95.0|-11.7|6.3|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 3||6.3|-11.7|
70927178|NCT03848065|141348664|OTHER||Difference in Percentages|2.2|||||TWO_SIDED|95.0|-6.0|11.6|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 3||11.6|-6.0|
70927179|NCT03848065|141348664|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference=% V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 4||8.5|-8.1|
70927180|NCT03848065|141348664|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 4||8.5|-7.9|
70927181|NCT03848065|141348664|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 4||7.9|-8.1|
70927182|NCT03848065|141348664|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 5||8.5|-8.1|
70927183|NCT03848065|141348664|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 5||8.5|-7.9|
70927184|NCT03848065|141348664|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 5||7.9|-8.1|
70927185|NCT03848065|141348664|OTHER||Difference in Percentages|-2.3|||||TWO_SIDED|95.0|-11.9|6.3|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 6A||6.3|-11.9|
70927186|NCT03848065|141348664|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 6A||8.5|-7.9|
70927187|NCT03848065|141348664|OTHER||Difference in Percentages|-2.3|||||TWO_SIDED|95.0|-11.9|5.8|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 6A||5.8|-11.9|
70927188|NCT03848065|141348664|OTHER||Difference in Percentages|-9.1|||||TWO_SIDED|95.0|-21.2|-0.2|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 6B||-0.2|-21.2|
70927189|NCT03848065|141348664|OTHER||Difference in Percentages|-6.7|||||TWO_SIDED|95.0|-17.9|2.1|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 6B||2.1|-17.9|
70927190|NCT03848065|141348664|OTHER||Difference in Percentages|-2.4|||||TWO_SIDED|95.0|-15.6|10.2|||||Difference=% V114 SC minus % V114 IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 6B||10.2|-15.6|
70927191|NCT03848065|141348664|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114 SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 7F||8.5|-8.1|
70927192|NCT03848065|141348664|OTHER||Difference in Percentages|-2.2|||||TWO_SIDED|95.0|-11.7|6.3|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 7F||6.3|-11.7|
70927193|NCT03848065|141348664|OTHER||Difference in Percentages|2.2|||||TWO_SIDED|95.0|-6.0|11.6|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 7F||11.6|-6.0|
70927194|NCT03848065|141348664|OTHER||Differences in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 9V||8.5|-8.1|
70927195|NCT03848065|141348664|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 9V||8.5|-7.9|
70927196|NCT03848065|141348664|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 9V||7.9|-8.1|
70927197|NCT03848065|141348664|OTHER||Difference in Percentages|-2.3|||||TWO_SIDED|95.0|-11.9|6.3|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 14||6.3|-11.9|
70927198|NCT03848065|141348664|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 14||8.5|-7.9|
70927199|NCT03848065|141348664|OTHER||Difference in Percentages|-2.3|||||TWO_SIDED|95.0|-11.9|5.8|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 14||5.8|-11.9|
70927200|NCT03848065|141348664|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 18C||8.5|-8.1|
70927201|NCT03848065|141348664|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 18C||8.5|-7.9|
70927202|NCT03848065|141348664|OTHER||Differences in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 18C||7.9|-8.1|
70927203|NCT03848065|141348664|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference=% V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 19A||8.5|-8.1|
70927204|NCT03848065|141348664|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 19A||8.5|-7.9|
70927205|NCT03848065|141348664|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 19A||7.9|-8.1|
70927206|NCT03848065|141348664|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference=% V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 19F||8.5|-8.1|
70927207|NCT03848065|141348664|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 19F||8.5|-7.9|
70927208|NCT03848065|141348664|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 19F||7.9|-8.1|
70927209|NCT03848065|141348664|OTHER||Difference in Percentages|0.1|||||TWO_SIDED|95.0|-9.8|10.4|||||Difference=% V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 23F||10.4|-9.8|
70927210|NCT03848065|141348664|OTHER||Difference in Percentages|2.4|||||TWO_SIDED|95.0|-5.7|12.4|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 23F||12.4|-5.7|
70927211|NCT03848065|141348664|OTHER||Difference in Percentages|-2.3|||||TWO_SIDED|95.0|-11.9|5.8|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 23F||5.8|-11.9|
70927212|NCT03848065|141348664|OTHER||Difference in Percentages|90.7|||||TWO_SIDED|95.0|77.2|96.4|||||Difference=% V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 22F||96.4|77.2|
70927213|NCT03848065|141348664|OTHER||Difference in Percentages|95.2|||||TWO_SIDED|95.0|84.1|98.7|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 22F||98.7|84.1|
70927214|NCT03848065|141348664|OTHER||Difference in Percentages|-4.5|||||TWO_SIDED|95.0|-15.2|3.6|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 22F||3.6|-15.2|
70927215|NCT03848065|141348664|OTHER||Difference in Percentages|81.8|||||TWO_SIDED|95.0|67.9|90.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 33F||90.5|67.9|
70927216|NCT03848065|141348664|OTHER||Difference in Percentages|88.9|||||TWO_SIDED|95.0|76.4|95.2|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 33F||95.2|76.4|
70927217|NCT03848065|141348664|OTHER||Difference in Percentages|-7.1|||||TWO_SIDED|95.0|-22.7|8.2|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 33F||8.2|-22.7|
70927218|NCT03848065|141348665|OTHER||Geometric Mean Concentration (GMC) Ratio|0.76|||||TWO_SIDED|95.0|0.58|1.0|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an analysis of variance (ANOVA) model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 1||1.00|0.58|
70927219|NCT03848065|141348665|OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.65|1.13|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|||1.13|0.65|
70927220|NCT03848065|141348665|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.68|1.16|||||GMC Ratio=GMC V114-SC/GMC V114-IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|||1.16|0.68|
70927221|NCT03848065|141348665|OTHER||GMC Ratio|1.3|||||TWO_SIDED|95.0|0.96|1.76|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 3||1.76|0.96|
70927222|NCT03848065|141348665|OTHER||GMC Ratio|1.49|||||TWO_SIDED|95.0|1.1|2.01|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 3||2.01|1.10|
70927223|NCT03848065|141348665|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.65|1.18|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 3||1.18|0.65|
70927224|NCT03848065|141348665|OTHER||GMC Ratio|0.72|||||TWO_SIDED|95.0|0.58|0.9|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 4||0.90|0.58|
70927225|NCT03848065|141348665|OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.65|1.0|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 4||1.00|0.65|
70927226|NCT03848065|141348665|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.72|1.11|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 4||1.11|0.72|
70927227|NCT03848065|141348665|OTHER||GMC Ratio|0.84|||||TWO_SIDED|95.0|0.6|1.16|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 5||1.16|0.60|
70927228|NCT03848065|141348665|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.69|1.31|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 5||1.31|0.69|
70927229|NCT03848065|141348665|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.64|1.21|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 5||1.21|0.64|
70927230|NCT03848065|141348665|OTHER||GMC Ratio|0.63|||||TWO_SIDED|95.0|0.47|0.84|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 6A||0.84|0.47|
70927231|NCT03848065|141348665|OTHER||GMC Ratio|0.69|||||TWO_SIDED|95.0|0.52|0.93|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 6A||0.93|0.52|
70927232|NCT03848065|141348665|OTHER||GMC Ratio|0.91|||||TWO_SIDED|95.0|0.68|1.21|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 6A||1.21|0.68|
70927233|NCT03848065|141348665|OTHER||GMC Ratio|0.53|||||TWO_SIDED|95.0|0.36|0.79|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 6B||0.79|0.36|
71009999|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|-6.2|STANDARD_ERROR_OF_MEAN|3.36|||TWO_SIDED|95.0|-13.16|0.76|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||0.76|-13.16|
70927234|NCT03848065|141348665|OTHER||GMC Ratio|0.6|||||TWO_SIDED|95.0|0.41|0.9|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 6B||0.90|0.41|
70927235|NCT03848065|141348665|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.59|1.3|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 6B||1.30|0.59|
70927236|NCT03848065|141348665|OTHER||GMC Ratio|0.61|||||TWO_SIDED|95.0|0.46|0.81|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 7F||0.81|0.46|
71010000|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|-1.61|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|-7.87|4.65|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||4.65|-7.87|
70927237|NCT03848065|141348665|OTHER||GMC Ratio|0.68|||||TWO_SIDED|95.0|0.52|0.9|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 7F||0.90|0.52|
70927238|NCT03848065|141348665|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.67|1.17|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 7F||1.17|0.67|
70927239|NCT03848065|141348665|OTHER||GMC Ratio|0.75|||||TWO_SIDED|95.0|0.57|0.99|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 9V||0.99|0.57|
70927240|NCT03848065|141348665|OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.65|1.13|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 9V||1.13|0.65|
70927241|NCT03848065|141348665|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.67|1.15|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 9V||1.15|0.67|
70927242|NCT03848065|141348665|OTHER||GMC Ratio|0.84|||||TWO_SIDED|95.0|0.6|1.19|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 14||1.19|0.60|
70927243|NCT03848065|141348665|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.72|1.43|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 14||1.43|0.72|
70927244|NCT03848065|141348665|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.59|1.16|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 14||1.16|0.59|
70927245|NCT03848065|141348665|OTHER||GMC Ratio|0.69|||||TWO_SIDED|95.0|0.53|0.9|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 18C||0.90|0.53|
70927246|NCT03848065|141348665|OTHER||GMC Ratio|0.71|||||TWO_SIDED|95.0|0.54|0.92|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 18C||0.92|0.54|
70927247|NCT03848065|141348665|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.76|1.27|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 18C||1.27|0.76|
70927248|NCT03848065|141348665|OTHER||GMC Ratio|0.87|||||TWO_SIDED|95.0|0.66|1.15|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 19A||1.15|0.66|
70927249|NCT03848065|141348665|OTHER||GMC Ratio|0.73|||||TWO_SIDED|95.0|0.55|0.96|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 19A||0.96|0.55|
70927250|NCT03848065|141348665|OTHER||GMC Ratio|1.19|||||TWO_SIDED|95.0|0.9|1.57|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 19A||1.57|0.90|
70927251|NCT03848065|141348665|OTHER||GMC Ratio|0.71|||||TWO_SIDED|95.0|0.57|0.89|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 19F||0.89|0.57|
70927252|NCT03848065|141348665|OTHER||GMC Ratio|0.77|||||TWO_SIDED|95.0|0.62|0.95|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 19F||0.95|0.62|
70927253|NCT03848065|141348665|OTHER||GMC Ratio|0.93|||||TWO_SIDED|95.0|0.75|1.15|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 19F||1.15|0.75|
70927254|NCT03848065|141348665|OTHER||GMC Ratio|0.79|||||TWO_SIDED|95.0|0.57|1.09|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 23F||1.09|0.57|
70927255|NCT03848065|141348665|OTHER||GMC Ratio|0.8|||||TWO_SIDED|95.0|0.58|1.09|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 23F||1.09|0.58|
70927256|NCT03848065|141348665|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.73|1.36|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 23F||1.36|0.73|
70927257|NCT03848065|141348665|OTHER||GMC Ratio|134.88|||||TWO_SIDED|95.0|88.91|204.62|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 22F||204.62|88.91|
70927258|NCT03848065|141348665|OTHER||GMC Ratio|204.6|||||TWO_SIDED|95.0|135.18|309.69|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 22F||309.69|135.18|
70927259|NCT03848065|141348665|OTHER||GMC Ratio|0.66|||||TWO_SIDED|95.0|0.44|0.99|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 22F||0.99|0.44|
70927260|NCT03848065|141348665|OTHER||GMC Ratio|25.11|||||TWO_SIDED|95.0|15.34|41.13|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 33F||41.13|15.34|
70927261|NCT03848065|141348665|OTHER||GMC Ratio|34.18|||||TWO_SIDED|95.0|20.93|55.83|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 33F||55.83|20.93|
70927262|NCT03848065|141348665|OTHER||GMC Ratio|0.73|||||TWO_SIDED|95.0|0.45|1.19|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 33F||1.19|0.45|
70927263|NCT03848065|141348666|OTHER||Difference in Percentages|2.5|||||TWO_SIDED|95.0|-7.7|13.9|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Diphtheria Toxin||13.9|-7.7|
70927264|NCT03848065|141348666|OTHER||Difference in Percentages|0.3|||||TWO_SIDED|95.0|-10.8|12.0|||||Difference = % V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Diphtheria Toxin||12.0|-10.8|
70927265|NCT03848065|141348666|OTHER||Difference in Percentages|2.2|||||TWO_SIDED|95.0|-8.0|13.0|||||Difference = % V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|Diphtheria Toxin||13.0|-8.0|
70927266|NCT03848065|141348666|OTHER||Difference in Percentages|2.4|||||TWO_SIDED|95.0|-5.8|12.4|||||Difference = % V114 SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Tetanus Toxin||12.4|-5.8|
70927267|NCT03848065|141348666|OTHER||Difference in Percentages|2.4|||||TWO_SIDED|95.0|-5.7|12.4|||||Difference = % V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Tetanus Toxin||12.4|-5.7|
70927268|NCT03848065|141348666|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference = % V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|Tetanus Toxin||7.9|-8.1|
70927269|NCT03848065|141348666|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Pertussis Toxin||8.5|-8.1|
70927270|NCT03848065|141348666|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference = % V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Pertussis Toxin||8.5|-7.9|
70927271|NCT03848065|141348666|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference = % V114 SC minus % V114 IM. The 95% CI is based on the Miettinen and Nurminen method.|Pertussis Toxin||7.9|-8.1|
70927272|NCT03848065|141348666|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Pertussis FHA||8.5|-8.1|
70927273|NCT03848065|141348666|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference = % V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Pertussis FHA||8.5|-7.9|
71046229|NCT02312713|141600654|SUPERIORITY||Mean Difference (Net)|0.0||||1|TWO_SIDED|95.0|-0.77|0.77|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||0.77|-0.77|1.00
71046230|NCT02312713|141600654|SUPERIORITY||Mean Difference (Final Values)|-0.44||||0.31|TWO_SIDED|95.0|-1.29|0.41|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||0.41|-1.29|0.31
71046231|NCT02312713|141600654|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.58|TWO_SIDED|95.0|-1.01|0.57|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||0.57|-1.01|0.58
71046232|NCT02312713|141600654|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.35||||0.32|TWO_SIDED|95.0|-0.33|1.03|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||1.03|-0.33|0.32
71046233|NCT02312713|141600654|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.22||||0.51|TWO_SIDED|95.0|-0.86|0.43|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||0.43|-0.86|0.51
71046234|NCT02312713|141600655|SUPERIORITY||Mean Difference (Final Values)|6.95||||0.48|TWO_SIDED|95.0|-12.31|26.22|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||26.22|-12.31|0.48
70927274|NCT03848065|141348666|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference = % V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|Pertussis FHA||7.9|-8.1|
71046235|NCT02312713|141600655|SUPERIORITY||Mean Difference (Final Values)|7.11||||0.41|TWO_SIDED|95.0|-9.69|23.91|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||23.91|-9.69|0.41
71046236|NCT02312713|141600655|SUPERIORITY||Mean Difference (Final Values)|-6.82||||0.5|TWO_SIDED|95.0|-26.55|12.91|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||12.91|-26.55|0.50
71046237|NCT02312713|141600655|SUPERIORITY||Mean Difference (Final Values)|7.02||||0.43|TWO_SIDED|95.0|-10.31|24.35|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||24.35|-10.31|0.43
71046238|NCT02312713|141600655|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-13.77||||0.09|TWO_SIDED|95.0|-29.73|2.19|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||2.19|-29.73|0.09
71046239|NCT02312713|141600655|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.09||||0.99|TWO_SIDED|95.0|-14.41|14.23|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||14.23|-14.41|0.99
71046240|NCT02312713|141600656|SUPERIORITY||Mean Difference (Final Values)|1.36||||0.04|TWO_SIDED|95.0|0.05|2.66|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for Strengthening Exercises||2.66|0.05|0.04
70927275|NCT03848065|141348666|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 1||8.5|-8.1|
70927276|NCT03848065|141348666|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference = % V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 1||8.5|-7.9|
70927277|NCT03848065|141348666|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference = % V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 1||7.9|-8.1|
70927278|NCT03848065|141348666|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 2||8.5|-8.1|
70927279|NCT03848065|141348666|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference = % V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 2||8.5|-7.9|
70927280|NCT03848065|141348666|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference = % V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 2||7.9|-8.1|
70927281|NCT03848065|141348666|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 3||8.5|-8.1|
70927282|NCT03848065|141348666|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||"Difference = % V114-IM minus % PCV13~-SC. The 95% CI is based on the Miettinen and Nurminen method."|Poliovirus Type 3||8.5|-7.9|
70927283|NCT03848065|141348666|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference = % V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 3||7.9|-8.1|
70927284|NCT04137367|141348698|OTHER|||||||0.05|||||||Mixed Models Analysis|||We estimated a priori that a total of 100 participants would be needed to detect a difference between ABM and sham condition, with a two-tailed α of 0.05 and (1-β) of .80. Power calculation was based on the assumption that 50 % of the participants allocated to ABM would report a minimum of 3 points reduction on BDI-II at six months, compared to 20 % in the sham condition. Assuming 15 % lost to follow up, power calculation indicated the need for 50 participants in each condition||||.05
70927285|NCT05403827|141348744|SUPERIORITY|||||||0.5019|||||||Control-Based Mean Imputation|||||||0.5019
70927286|NCT05403827|141348745|SUPERIORITY|||||||0.2028|||||||Control-Based Mean Imputation|||||||0.2028
71010001|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|-0.63|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-6.85|5.59|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||5.59|-6.85|
71010002|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|-6.91|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-12.74|-1.08|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||-1.08|-12.74|
71010003|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|-4.04|STANDARD_ERROR_OF_MEAN|2.74|||TWO_SIDED|95.0|-9.73|1.66|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||1.66|-9.73|
71010004|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|-8.25|STANDARD_ERROR_OF_MEAN|2.57|||TWO_SIDED|95.0|-13.59|-2.91|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||-2.91|-13.59|
71010005|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|-5.56|STANDARD_ERROR_OF_MEAN|2.5|||TWO_SIDED|95.0|-10.76|-0.35|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||-0.35|-10.76|
71010006|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|-7.07|STANDARD_ERROR_OF_MEAN|3.91|||TWO_SIDED|95.0|-15.2|1.05|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||1.05|-15.20|
70927287|NCT05403827|141348746|SUPERIORITY|||||||0.1914|||||||Control-Based Mean Imputation|||||||0.1914
70927288|NCT05403827|141348747|SUPERIORITY|||||||0.2512|||||||Control-Based Mean Imputation|||||||0.2512
70927289|NCT05403827|141348748|SUPERIORITY|||||||0.7906|||||||Control-Based Mean Imputation|||||||0.7906
70927290|NCT05403827|141348749|SUPERIORITY|||||||0.5343|||||||Control-Based Mean Imputation|||||||0.5343
70927291|NCT05403827|141348750|SUPERIORITY|||||||0.3757|||||||Control-Based Mean Imputation|||||||0.3757
70927292|NCT03381196|141348852|SUPERIORITY|||||||0.0216|||||||Gehan-Wilcoxon test|||||||0.0216
71010007|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|-5.85|STANDARD_ERROR_OF_MEAN|3.77|||TWO_SIDED|95.0|-13.68|1.98|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||1.98|-13.68|
71010008|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|-1.4|STANDARD_ERROR_OF_MEAN|4.2|||TWO_SIDED|95.0|-10.14|7.33|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||7.33|-10.14|
71010009|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|-5.16|STANDARD_ERROR_OF_MEAN|3.99|||TWO_SIDED|95.0|-13.46|3.14|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||3.14|-13.46|
71010010|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|-2.37|STANDARD_ERROR_OF_MEAN|3.74|||TWO_SIDED|95.0|-10.14|5.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||5.40|-10.14|
70927293|NCT02677805|141348946|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70927294|NCT02677805|141348947|SUPERIORITY|||||||0.087||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary Outcome Measure shows a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||||||0.087
70927295|NCT02677805|141348948|SUPERIORITY|||||||0.121||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||||||0.121
70927296|NCT02677805|141348949|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||Test performed for Investigator's In-clinic Assessment||||<0.001
70927297|NCT02677805|141348949|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||Test performed for Subject's In-clinic Assessment||||<0.001
71046241|NCT02312713|141600656|SUPERIORITY||Mean Difference (Final Values)|1.21||||0.09|TWO_SIDED|95.0|-0.18|2.6|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for Strengthening Exercises.||2.6|-0.18|0.09
70927298|NCT02677805|141348950|SUPERIORITY|||||||0.218||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||Test performed for responders rates at week 20||||0.218
71046242|NCT02312713|141600656|SUPERIORITY||Mean Difference (Final Values)|0.85||||0.22|TWO_SIDED|95.0|-0.49|2.19|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Strengthening Exercises.||2.19|-0.49|0.22
71046243|NCT02312713|141600656|SUPERIORITY||Mean Difference (Final Values)|1.35||||0.06|TWO_SIDED|95.0|-0.08|2.78|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Strengthening Exercises.||2.78|-0.08|0.06
71046244|NCT02312713|141600656|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.51||||0.36|TWO_SIDED|95.0|-1.6|0.58|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Strength.||0.58|-1.6|0.36
71046245|NCT02312713|141600656|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.14||||0.81|TWO_SIDED|95.0|-1.03|1.31|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Strength.||1.31|-1.03|0.81
71046246|NCT02312713|141600656|SUPERIORITY||Mean Difference (Final Values)|1.85||||0|TWO_SIDED|95.0|0.67|3.03|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for Stretching.||3.03|0.67|0.00
71046247|NCT02312713|141600656|SUPERIORITY||Mean Difference (Final Values)|1.62||||0|TWO_SIDED|95.0|0.55|2.68|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for Stretching.||2.68|0.55|0.00
71046248|NCT02312713|141600656|SUPERIORITY||Mean Difference (Final Values)|1.37||||0.03|TWO_SIDED|95.0|0.16|2.57|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Stretching.||2.57|0.16|0.03
71046249|NCT02312713|141600656|SUPERIORITY||Mean Difference (Final Values)|2.07||||0|TWO_SIDED|95.0|0.98|3.16|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Stretching.||3.16|0.98|0.00
71046250|NCT02312713|141600656|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.48||||0.33|TWO_SIDED|95.0|-1.46|0.5|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Stretching.||0.5|-1.46|0.33
71046251|NCT02312713|141600656|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.45||||0.32|TWO_SIDED|95.0|-0.44|1.34|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Stretching.||1.34|-0.44|0.32
71046252|NCT02312713|141600656|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.21|TWO_SIDED|95.0|-0.61|2.8|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for Aerobic Exercise.||2.8|-0.61|0.21
71046253|NCT02312713|141600656|SUPERIORITY||Mean Difference (Final Values)|2.07||||0.04|TWO_SIDED|95.0|0.13|4.0|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for Aerobic Exercise.||4|0.13|0.04
71046254|NCT02312713|141600656|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.03|TWO_SIDED|95.0|0.15|3.62|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Aerobic Exercise.||3.62|0.15|0.03
71103473|NCT00863304|141714821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.22||0.467|TWO_SIDED|95.0|-0.27|0.59||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.59|-0.27|0.467
71046255|NCT02312713|141600656|SUPERIORITY||Mean Difference (Final Values)|1.99||||0.05|TWO_SIDED|95.0|0.01|3.97|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Aerobic Exercise.||3.97|0.01|0.05
71103474|NCT00863304|141714821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.28|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.74|-0.83||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.83|-1.74|<0.001
70927299|NCT02677805|141348951|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for Modified Skindex-16 (GL-QoL) Emotional domain - Change from Baseline at Week 4||||<0.001
70927300|NCT02677805|141348951|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for Modified Skindex-16 (GL-QoL) Social Functioning domain - Change from Baseline at Week 4||||<0.001
70927301|NCT02677805|141348951|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for Modified Skindex-16 (GL-QoL) Overall score - Change from Baseline at Week 4.||||<0.001
70927302|NCT02677805|141348951|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for FACE-Q Appraisal of Lines Between Eyebrows - Change from Baseline at Week 4||||<0.001
70927303|NCT02677805|141348951|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for FACE-Q Age Appraisal VAS score||||<0.001
70927304|NCT03150173|141348978|SUPERIORITY|||||||0.94|||||||Chi-squared|||||||0.94
70927305|NCT04204265|141349168|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
70927306|NCT04204265|141349169|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
70927307|NCT04204265|141349170|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
70927308|NCT03468868|141349192|NON_INFERIORITY|We chose a non-inferiority margin of 10% (or 0.10 feet per second) for this population.|Mean Difference (Final Values)|0.15|STANDARD_DEVIATION|1.1|<|0.01|TWO_SIDED|95.0|-0.14|0.44|||t-test, 2 sided|||||0.44|-0.14|<0.01
70927309|NCT03468868|141349193|SUPERIORITY||Mean Difference (Final Values)|72.46|STANDARD_DEVIATION|384.1||0.16|TWO_SIDED|95.0|-29.56|174.5|||t-test, 2 sided|||||174.5|-29.56|0.16
70927310|NCT03468868|141349194|SUPERIORITY||Mean Difference (Final Values)|-4.71|STANDARD_DEVIATION|24.96||0.13|TWO_SIDED|95.0|-10.84|1.41|||t-test, 2 sided|||||1.41|-10.84|0.13
70927311|NCT03468868|141349195|SUPERIORITY||Mean Difference (Final Values)|0.88|STANDARD_DEVIATION|18.22||0.7|TWO_SIDED|95.0|-3.55|5.32|||t-test, 2 sided|||||5.32|-3.55|0.70
70927312|NCT03468868|141349196|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_DEVIATION|6.71||0.43|TWO_SIDED|95.0|-0.97|2.3|||t-test, 2 sided|||NeuroQOL Anxiety Domain||2.30|-0.97|0.43
70927313|NCT03468868|141349196|SUPERIORITY||Mean Difference (Final Values)|0.24|STANDARD_DEVIATION|6.16||0.75|TWO_SIDED|95.0|-1.26|1.74|||t-test, 2 sided|||NeuroQOL Depression Domain||1.74|-1.26|0.75
70927314|NCT03468868|141349196|SUPERIORITY||Mean Difference (Final Values)|-0.87|STANDARD_DEVIATION|7.54||0.35|TWO_SIDED|95.0|-2.71|0.97|||t-test, 2 sided|||NeuroQOL Fatigue Domain||0.97|-2.71|0.35
70927315|NCT03468868|141349196|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_DEVIATION|3.83||0.91|TWO_SIDED|95.0|-0.88|0.99|||t-test, 2 sided|||NeuroQOL Upper Extremity Function Domain||0.99|-0.88|0.91
70927316|NCT03468868|141349196|SUPERIORITY||Mean Difference (Final Values)|1.52|STANDARD_DEVIATION|5.44||0.02|TWO_SIDED|95.0|0.2|2.85|||t-test, 2 sided|||NeuroQOL Lower Extremity Function Domain||2.85|0.20|0.02
70927317|NCT03468868|141349196|SUPERIORITY||Mean Difference (Final Values)|-0.89||||0.29|TWO_SIDED|95.0|-2.54|0.76|||t-test, 2 sided|||NeuroQOL Cognitive Function Domain||0.76|-2.54|0.29
70927318|NCT03468868|141349196|SUPERIORITY||Mean Difference (Final Values)|1.08||||0.11|TWO_SIDED|95.0|-0.26|2.42|||t-test, 2 sided|||NeuroQOL Emotional and Behavioral Dyscontrol Domain||2.42|-0.26|0.11
70927319|NCT03468868|141349196|SUPERIORITY||Mean Difference (Final Values)|0.55|STANDARD_DEVIATION|7.13||0.54|TWO_SIDED|95.0|-1.19|2.28|||t-test, 2 sided|||NeuroQOL Positive Affect and Well-Being Domain||2.28|-1.19|0.54
70927320|NCT03468868|141349196|SUPERIORITY||Mean Difference (Final Values)|-0.59|STANDARD_DEVIATION|5.76||0.41|TWO_SIDED|95.0|-2.0|0.81|||t-test, 2 sided|||NeuroQOL Sleep Disturbance Domain||0.81|-2.00|0.41
70927321|NCT03468868|141349196|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|6.65||0.63|TWO_SIDED|95.0|-1.22|2.02|||t-test, 2 sided|||NeuroQOL Ability to Participate in Social Roles and Activities Domain||2.02|-1.22|0.63
70927322|NCT03468868|141349196|SUPERIORITY||Mean Difference (Final Values)|0.65|STANDARD_DEVIATION|7.44||0.48|TWO_SIDED|95.0|-1.16|2.47|||t-test, 2 sided|||NeuroQOL Satisfaction with Social Roles and Activities Domain||2.47|-1.16|0.48
70927323|NCT03468868|141349196|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_DEVIATION|5.68||0.92|TWO_SIDED|95.0|-1.32|1.45|||t-test, 2 sided|||NeuroQOL Stigma Domain||1.45|-1.32|0.92
70927324|NCT03468868|141349196|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_DEVIATION|3.45||0.28|TWO_SIDED|95.0|-1.31|0.37|||t-test, 2 sided|||NeuroQOL Communication Domain||0.37|-1.31|0.28
70927325|NCT03468868|141349197|SUPERIORITY||Mean Difference (Final Values)|-2.48|STANDARD_DEVIATION|20.63||0.34|TWO_SIDED|95.0|-7.55|2.6|||t-test, 2 sided|||MSIS Physical||2.60|-7.55|0.34
70927326|NCT03468868|141349197|SUPERIORITY||Mean Difference (Final Values)|-1.38|STANDARD_DEVIATION|21.37||0.24|TWO_SIDED|95.0|-6.63|3.88|||t-test, 2 sided|||MSIS Psychological||3.88|-6.63|0.24
70927327|NCT03468868|141349198|SUPERIORITY||Mean Difference (Final Values)|0.37|STANDARD_DEVIATION|8.91||0.74|TWO_SIDED|95.0|-1.83|2.56|||t-test, 2 sided|||MFIS Cognitive||2.56|-1.83|0.74
70927328|NCT03468868|141349198|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_DEVIATION|8.03||0.04|TWO_SIDED|95.0|-4.07|-0.12|||t-test, 2 sided|||MFIS Physical||-0.12|-4.07|0.04
70927329|NCT03468868|141349198|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_DEVIATION|2.17||0.59|TWO_SIDED|95.0|-0.68|0.39|||t-test, 2 sided|||MFIS Psychosocial||0.39|-0.68|0.59
70927330|NCT03468868|141349198|SUPERIORITY||Mean Difference (Final Values)|-1.88|STANDARD_DEVIATION|17.0||0.38|TWO_SIDED|95.0|-6.05|2.3|||t-test, 2 sided|||MFIS Total||2.30|-6.05|0.38
70927331|NCT03468868|141349199|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_DEVIATION|1.18||0.87|TWO_SIDED|95.0|-0.34|0.29|||t-test, 2 sided|||||0.29|-0.34|0.87
70927332|NCT03468868|141349200|SUPERIORITY||Mean Difference (Final Values)|-0.54|STANDARD_DEVIATION|2.21||0.05|TWO_SIDED|95.0|-1.08|0.0|||t-test, 2 sided|||||0.00|-1.08|0.05
70927333|NCT05399459|141349201|SUPERIORITY||Adjusted percentage difference|19.4|||<|0.0001|TWO_SIDED|95.0|12.0|26.8|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg - placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||26.8|12.0|<0.0001
70927334|NCT05399459|141349202|SUPERIORITY||Adjusted percentage difference|22.7|||<|0.0001|TWO_SIDED|95.0|14.5|30.9|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg - placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||30.9|14.5|<0.0001
70927335|NCT05399459|141349203|SUPERIORITY||Adjusted percentage difference|14.8||||0.0011|TWO_SIDED|95.0|5.9|23.6|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg- placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||23.6|5.9|0.0011
70927336|NCT05399459|141349204|SUPERIORITY||Adjusted percentage difference|18.8|||<|0.0001|TWO_SIDED|95.0|10.1|27.4|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg- placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||27.4|10.1|<0.0001
70927337|NCT05399459|141349205|SUPERIORITY||Adjusted percentage difference|31.7|||<|0.0001|TWO_SIDED|95.0|23.2|40.3|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg- placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||40.3|23.2|<0.0001
70927338|NCT05399459|141349206|SUPERIORITY||Adjusted percentage difference|-19.7|||<|0.0001|TWO_SIDED|95.0|-27.8|-11.6|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg- placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||-11.6|-27.8|<0.0001
70927339|NCT05399459|141349207|SUPERIORITY||Adjusted percentage difference|33.1|||<|0.0001|TWO_SIDED|95.0|24.7|41.6|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg- placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||41.6|24.7|<0.0001
70927340|NCT05399459|141349208|SUPERIORITY||Adjusted percentage difference|10.1||||0.0707|TWO_SIDED|95.0|-0.9|21.1||P-value \> 0.05; therefore, all secondary outcome measures listed after this outcome measure in the hierarchy were not tested.|Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg- placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||21.1|-0.9|0.0707
70927341|NCT00324805|141349292|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9|TWO_SIDED|95.0|0.82|1.19|||Regression, Cox||Arm II versus Arm I|||1.19|0.82|0.90
70927342|NCT00324805|141349293|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.95|TWO_SIDED|95.0|0.86|1.15|||Regression, Cox||Arm II vs. Arm I|||1.15|0.86|0.95
71010011|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|-4.51|STANDARD_ERROR_OF_MEAN|3.72|||TWO_SIDED|95.0|-12.25|3.23|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||3.23|-12.25|
71010012|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|-0.44|STANDARD_ERROR_OF_MEAN|3.44|||TWO_SIDED|95.0|-7.6|6.72|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||6.72|-7.60|
71010013|NCT03091920|141526976|OTHER|No statistical testing was performed.|Least squares mean difference|-1.98|STANDARD_ERROR_OF_MEAN|3.32|||TWO_SIDED|95.0|-8.88|4.92|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||4.92|-8.88|
71046256|NCT02312713|141600656|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.79||||0.27|TWO_SIDED|95.0|-0.62|2.2|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Aerobic Exercise.||2.2|-0.62|0.27
70927343|NCT03931174|141349297|SUPERIORITY|Unit of analysis is the provider level. All 186 providers (95 ATTC, 91 E-ATTC) who enrolled in the study are included in the analysis.|Odds Ratio (OR)|2.41|STANDARD_ERROR_OF_MEAN|0.53||0.097|TWO_SIDED|95.0|0.85|6.81||CM Exposure is reported as the estimated proportion of providers delivering 10 or more CM sessions to at least one patient in a mixed model accounting for nesting.|Mixed Models Analysis|||These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.||6.81|0.85|0.097
70927344|NCT03931174|141349298|SUPERIORITY|Unit of analysis is the provider level. All 186 providers (95 ATTC, 91 E-ATTC) who enrolled in the study are included in the analysis.|Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|0.31||0.02|TWO_SIDED|95.0|0.11|1.32|||t-test, 2 sided|T-test adjusted for inequality of variances||These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.||1.32|0.11|0.02
71103475|NCT00863304|141714821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.12|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.58|-0.66||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.66|-1.58|<0.001
71103476|NCT00863304|141714821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.23||0.002|TWO_SIDED|95.0|-1.19|-0.27||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.27|-1.19|0.002
71103477|NCT00863304|141714821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.23||0.019|TWO_SIDED|95.0|-1.01|-0.09||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.09|-1.01|0.019
70927345|NCT03931174|141349299|SUPERIORITY|Unit of analysis is the organization-level. Total number of organizations included in the analysis is 28 (14 ATTC, 14 E-ATTC).|Chi-square test statistic value|0.662||||0.43|TWO_SIDED||||||Chi-squared|Pearson Chi-Square||These analyses are unadjusted.||||0.430
70927346|NCT03931174|141349300|SUPERIORITY|Analyses are at the patient-level. All patients who enrolled in the study are included in the analysis.|Mean Difference (Final Values)|-0.695|STANDARD_ERROR_OF_MEAN|0.313||0.034|TWO_SIDED|95.0|-1.3|-0.08|||Mixed Models Analysis|||These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.||-0.08|-1.30|.034
70927347|NCT03931174|141349301|SUPERIORITY|Analyses are at the patient-level. All patients who enrolled in the study are included in the analysis.|Mean Difference (Final Values)|-0.202|STANDARD_ERROR_OF_MEAN|0.314||0.27|TWO_SIDED|95.0|-0.82|0.41|||Mixed Models Analysis|||These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.||0.41|-0.82|0.27
70927348|NCT03931174|141349302|SUPERIORITY|Analyses are at the provider-level. Only those providers who completed the post-implementation survey (at the end of the 9-month implementation phase) were included in the analysis.|Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.191||0.011|TWO_SIDED|95.0|-0.88|0.12||Means were compared between conditions in an independent-samples T-test.|t-test, 2 sided|T-test adjusted for inequality of variances||These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.||0.12|-0.88|.011
70927349|NCT03931174|141349303|SUPERIORITY|Analyses are at the provider-level. Only those providers who completed the post-implementation survey (at the end of the 9-month implementation phase) were included in the analysis.|Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.232||0.218|TWO_SIDED|95.0|-0.75|0.17||Means of leadership engagement scores were compared between conditions in an independent-samples T-test.|t-test, 2 sided|||These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.||0.17|-0.75|.218
70927350|NCT03852472|141349324|OTHER||% Difference (Avacopan - Placebo)|-8.4||||0.1321|TWO_SIDED|95.0|-18.7|2.4||P-values are obtained from a CMH test stratified by stratification factors Hurley Stage (Stage II vs III), and anti-TNF drug use (Treatment naive vs Previous treatment).|Cochran-Mantel-Haenszel|||||2.4|-18.7|0.1321
70927351|NCT03852472|141349324|OTHER||% Difference (Avacopan - Placebo)|4.3||||0.4503|TWO_SIDED|95.0|-6.9|15.5||P-values are obtained from a CMH test stratified by stratification factors Hurley Stage (Stage II vs III), and anti-TNF drug use (Treatment naive vs Previous treatment)|Cochran-Mantel-Haenszel|||||15.5|-6.9|0.4503
70927352|NCT03852472|141349325|OTHER||Least Squares Mean|0.6|STANDARD_ERROR_OF_MEAN|1.17||0.5784|TWO_SIDED|95.0|-1.7|2.9|||Mixed model for repeated measures|||||2.9|-1.7|0.5784
70927353|NCT03852472|141349325|OTHER||Least Squares Mean|-1.4|STANDARD_ERROR_OF_MEAN|1.17||0.2253|TWO_SIDED|95.0|-3.7|0.9|||Mixed effects model for repeated measure|||||0.9|-3.7|0.2253
70927354|NCT05977530|141349337|SUPERIORITY||comparison of ranks in Wilcoxon|0.0|||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<.01
70927355|NCT03161028|141349382|SUPERIORITY|||||||0.51||||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||For the model evaluating the primary outcome (change in T25FW), T25FW was transformed to walking speed by dividing 25 feet by the completion time in seconds (ft/sec). Any participants who were unable to complete the T25FW at any timepoint after baseline were assigned a value of 199 seconds, a statistical technique known as Winsorizing.||||0.51
70927356|NCT03161028|141349383|SUPERIORITY|||||||0.902|||||||Mixed Models Analysis|||||||0.902
70927357|NCT03161028|141349384|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|||||||0.90
70927358|NCT03161028|141349385|SUPERIORITY|||||||0.084|||||||Mixed Models Analysis|||||||0.084
70927359|NCT03161028|141349386|SUPERIORITY|||||||0.134|||||||Chi-squared|||||||0.134
70927360|NCT03492216|141349388|SUPERIORITY||Risk Difference (RD)|7.6||||0.0025|TWO_SIDED|95.0|2.7|12.5|||Regression, Logistic||adjusted risk difference for non-hazardous alcohol use, alcohol incentive groups compared to no alcohol incentive groups. logistic regression model adjusted for INH incentive arm, participant sex, and study site.|||12.5|2.7|0.0025
70927361|NCT03492216|141349389|SUPERIORITY||Risk Difference (RD)|-0.2||||0.9435|TWO_SIDED|95.0|-7.0|6.5|||Regression, Logistic||adjusted risk difference for \>90% INH adherence, INH incentive group compared to no INH incentives. logistic regression model adjusted for alcohol incentive arm, participant sex and study site.|||6.5|-7.0|0.9435
70927362|NCT03492216|141349392|SUPERIORITY||Risk Difference (RD)|-2.5||||0.26|TWO_SIDED|95.0|-6.8|1.9|||Regression, Logistic||adjusted risk different for HIV viral suppression at 12 months, Arm 2 (escalating incentives; EtG tests) compared to Arm 1 (control); logistic regression model adjusted for randomization arm, participant sex, and study site.|||1.9|-6.8|0.26
70927363|NCT03492216|141349392|SUPERIORITY||Risk Difference (RD)|0.7||||0.7|TWO_SIDED|95.0|-2.8|4.1|||Regression, Logistic||adjusted risk different for HIV viral suppression at 12 months, Arm 3 (escalating incentives; IsoScreen tests) compared to Arm 1 (control); logistic regression model adjusted for randomization arm, participant sex, and study site.|||4.1|-2.8|0.70
70927364|NCT03492216|141349392|SUPERIORITY||Risk Difference (RD)|1.3||||0.42|TWO_SIDED|95.0|-1.9|4.5|||Regression, Logistic||adjusted risk different for HIV viral suppression at 12 months, Arm 4 (escalating incentives; EtG and IsoScreen tests) compared to Arm 1 (control); logistic regression model adjusted for randomization arm, participant sex, and study site.|||4.5|-1.9|0.42
70927365|NCT01037881|141349464|SUPERIORITY||Difference in least squares mean|-1.29||||0.27|TWO_SIDED|95.0|-3.6|1.03|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.||1.03|-3.60|0.27
71046257|NCT02312713|141600656|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.07||||0.93|TWO_SIDED|95.0|-1.69|1.54|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Aerobic Exercise.||1.54|-1.69|0.93
70927366|NCT01037881|141349464|SUPERIORITY||Difference in least squares mean|-0.25||||0.83|TWO_SIDED|95.0|-2.53|2.04|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.||2.04|-2.53|0.83
70927367|NCT01037881|141349464|SUPERIORITY||Difference in least squares mean|-2.01||||0.08|TWO_SIDED|95.0|-4.3|0.28|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.||0.28|-4.30|0.08
70927368|NCT01037881|141349464|SUPERIORITY||Difference in least squares mean|-1.56||||0.16|TWO_SIDED|95.0|-3.77|0.65|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.||0.65|-3.77|0.16
70927369|NCT01037881|141349464|SUPERIORITY||Difference in least squares mean|-1.65||||0.14|TWO_SIDED|95.0|-3.84|0.54|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.||0.54|-3.84|0.14
70927370|NCT01037881|141349464|SUPERIORITY||Difference in least squares mean|-2.46||||0.04|TWO_SIDED|95.0|-4.47|-0.17|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.||-0.17|-4.47|0.04
70927371|NCT01037881|141349464|SUPERIORITY||Difference in least squares mean|2.46||||0.04|TWO_SIDED|95.0|0.17|4.74|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.||4.74|0.17|0.04
70927372|NCT01037881|141349464|SUPERIORITY||Difference in least squares mean|1.17||||0.32|TWO_SIDED|95.0|-1.14|3.48|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.||3.48|-1.14|0.32
70927373|NCT01037881|141349464|SUPERIORITY||Difference in least squares mean|2.21||||0.06|TWO_SIDED|95.0|-0.08|4.5|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.||4.50|-0.08|0.06
70927374|NCT01037881|141349464|SUPERIORITY||Difference in least squares mean|0.45||||0.7|TWO_SIDED|95.0|-1.84|2.73|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.||2.73|-1.84|0.70
70927375|NCT01037881|141349464|SUPERIORITY||Difference in least squares mean|0.9||||0.42|TWO_SIDED|95.0|-1.31|3.1|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.||3.10|-1.31|0.42
70927376|NCT01037881|141349464|SUPERIORITY||Difference in least squares mean|0.81||||0.47|TWO_SIDED|95.0|-1.38|3.0|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.||3.00|-1.38|0.47
70927377|NCT00764751|141349470|SUPERIORITY||Mean Difference (Final Values)|15.4|||=|0.003|TWO_SIDED|95.0|5.6|25.0|||Paired t-test|||||25|5.6|=0.003
70927378|NCT00764751|141349470|SUPERIORITY||Mean Difference (Final Values)|-17.1||||0.07|TWO_SIDED|95.0|-36.0|1.9|||Paired t-test|||||1.9|-36.0|0.07
70927379|NCT04563546|141349479|OTHER||||||<|0.001||||||Unadjusted p-value. Threshold for statistical significance = 0.05|Chi-squared|||||||<0.001
70927380|NCT04563546|141349480|OTHER|||||||0.739|||||||Chi-squared|||||||0.739
70927381|NCT04563546|141349481|OTHER||||||<|0.001||||||Unadjusted p-value. Threshold for statistical significance = 0.05|Chi-squared|||||||<0.001
70927382|NCT06074172|141349513|OTHER|Linear Mixed Models were done with a compound symmetry covariance structure. This infers that the variances (pooled within-group) and covariances (across subjects) of all of the repeated measures are homogenous.||||||0.008||||||In the Bonferroni corrected Linear Mixed Model for PI Ratio, the p-value for the following interaction was reported: Treatment\*Age.|Linear Mixed Model|"Linear Mixed Model analyses:~1. Factor: Treatment group~2. Covariates: Age, Sex, CBD Use history, and Urine THC~3. Interactions"||||||0.008
70927383|NCT03020199|141349517|SUPERIORITY||Odds Ratio (OR)|16.8|||<|0.0001|TWO_SIDED|95.0|5.9|48.3|||Regression, Logistic||Logistic regression model with treatment as an explanatory variable and subset of significant covariates (including Baseline PASI score, age, BMI and their interaction terms with treatment) selected using forward selection method.|Week 52 PASI 90||48.3|5.9|<0.0001
70927384|NCT03020199|141349518|SUPERIORITY||Odds Ratio (OR)|0.8||||0.653|TWO_SIDED|95.0|0.3|2.1|||Regression, Logistic||Exact logistic regression method for Treatment group comparison, without using any covariates.|Week 104 PASI 90||2.1|0.3|0.6530
70927385|NCT05583578|141349520|SUPERIORITY|||||||0.012||||||The Threshold for statistical significance was p=0.05|t-test, 2 sided|||||||0.012
70927386|NCT05583578|141349520|OTHER||Cohen's d (effect size)|0.98|||||TWO_SIDED||||||||Effect sizes greater than (d = 0.80) were considered large.|Post-intervention changes in walking speed||||
70927387|NCT05583578|141349521|SUPERIORITY|||||||0.39||||||The threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.39
70927388|NCT05583578|141349521|SUPERIORITY||Cohen's d (effect size)|0.31|||||TWO_SIDED||||||||Effect sizes ranging from 0.21 to 0.79 were considered moderate, anything ≥0.80 were considered large.|||||
70927389|NCT04005794|141349529|OTHER|||||||0.004||||||Social latency t = 3.215|t-test, 2 sided|||||||0.004
70927390|NCT04005794|141349530|OTHER|||||||0.213|||||||ANOVA|||||||0.213
70927391|NCT04005794|141349531|OTHER|||||||0.01|||||||ANOVA|||||||0.01
70927392|NCT04005794|141349532|OTHER|||||||0.004|||||||ANOVA|||||||0.004
70927393|NCT04005794|141349533|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
70927394|NCT02547363|141349545|SUPERIORITY||||||<|0.001|||||||Fisher exact test|||||||<0.001
70927395|NCT02547363|141349546|SUPERIORITY||Ratio of clearance rates|62.59|||<|0.001|TWO_SIDED|95.0|8.68|451.08|||Mantel Haenszel||Mantel-Haenszel estimate (0.037% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||451.08|8.68|<0.001
70927396|NCT02547363|141349547|SUPERIORITY||Ratio of clearance rates|59.21|||<|0.001|TWO_SIDED|95.0|8.44|415.35|||Mantel Haenszel||Mantel-Haenszel estimate (0.037% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||415.35|8.44|<0.001
70927397|NCT02547363|141349548|SUPERIORITY||Week 8 AK count ratio|0.27|||<|0.001|TWO_SIDED|95.0|0.23|0.32|||Mantel Haenszel||0.037% relative to vehicle.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||0.32|0.23|<0.001
70927398|NCT04447469|141349549|SUPERIORITY||Odds Ratio (OR)|2.069||||0.2598|TWO_SIDED|95.0|0.555|8.615||P-value and odds ratio were calculated using Fisher's Exact test.|Fisher Exact|||||8.615|0.555|0.2598
70927399|NCT04447469|141349549|SUPERIORITY||Odds Ratio (OR)|2.414||||0.161|TWO_SIDED|95.0|0.653|9.957||P-value and odds ratio were calculated using Fisher's Exact test.|Fisher Exact|||||9.957|0.653|0.1610
70927400|NCT04447469|141349549|SUPERIORITY||Stratified Odds Ratio|2.091||||0.2448|TWO_SIDED|95.0|0.612|7.144||P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (standard of care antiretroviral therapy, age, and ARDS status).|Cochran-Mantel-Haenszel|||||7.144|0.612|0.2448
70927401|NCT04447469|141349549|SUPERIORITY||Stratified Odds Ratio|2.749||||0.1378|TWO_SIDED|95.0|0.756|9.993||P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (standard of care antiretroviral therapy, age, and ARDS status).|Cochran-Mantel-Haenszel|||||9.993|0.756|0.1378
70927402|NCT04447469|141349550|SUPERIORITY||Stratified Odds Ratio|1.231||||0.4534|TWO_SIDED|95.0|0.715|2.12||P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (age and ARDS status).|Cochran-Mantel-Haenszel|||||2.120|0.715|0.4534
70927403|NCT04447469|141349550|SUPERIORITY||Stratified Odds Ratio|1.097||||0.7414|TWO_SIDED|95.0|0.636|1.891||P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (age and ARDS status).|Cochran-Mantel-Haenszel|||||1.891|0.636|0.7414
70927404|NCT04447469|141349551|SUPERIORITY||Odds Ratio (OR)|0.984||||1|TWO_SIDED|95.0|0.198|4.884|||Fisher Exact|||||4.884|0.198|1.0000
70927405|NCT04447469|141349551|SUPERIORITY||Odds Ratio (OR)|1.286||||1|TWO_SIDED|95.0|0.26|6.417|||Fisher Exact|||||6.417|0.260|1.0000
70927406|NCT04447469|141349552|SUPERIORITY||Difference in Proportion|-15.0|||||TWO_SIDED|95.0|-45.6|15.6|||||95% CI were calculated using asymptotic normal approximation. Difference = KPL-301 - placebo.|||15.6|-45.6|
70927407|NCT04447469|141349552|SUPERIORITY||Difference in Proportions|-27.7|||||TWO_SIDED|95.0|-56.4|0.9|||||95% CI were calculated using asymptotic normal approximation. Difference = KPL-301 - Placebo .|||0.9|-56.4|
70927408|NCT04447469|141349553|SUPERIORITY|||||||0.6229||||||Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).|Log Rank|||||||0.6229
71010014|NCT03091920|141526977|OTHER|No statistical testing was performed.|Least squares mean difference|3.19|STANDARD_ERROR_OF_MEAN|1.59|||TWO_SIDED|95.0|-0.1|6.48|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||6.48|-0.10|
71010015|NCT03091920|141526977|OTHER|No statistical testing was performed.|Least squares mean difference|3.53|STANDARD_ERROR_OF_MEAN|1.58|||TWO_SIDED|95.0|0.25|6.82|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||6.82|0.25|
71010016|NCT03091920|141526977|OTHER|No statistical testing was performed.|Least squares mean difference|3.36|STANDARD_ERROR_OF_MEAN|1.43|||TWO_SIDED|95.0|0.4|6.32|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1||6.32|0.40|
71010017|NCT03091920|141526977|OTHER|No statistical testing was performed.|Least squares mean difference|4.59|STANDARD_ERROR_OF_MEAN|1.76|||TWO_SIDED|95.0|0.95|8.23|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||8.23|0.95|
71010018|NCT03091920|141526977|OTHER|No statistical testing was performed.|Least squares mean difference|4.49|STANDARD_ERROR_OF_MEAN|1.75|||TWO_SIDED|95.0|0.86|8.12|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||8.12|0.86|
70927409|NCT04447469|141349553|SUPERIORITY|||||||0.5526||||||Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).|Log Rank|||||||0.5526
70927410|NCT04447469|141349554|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.9426|TWO_SIDED|80.0|0.71|1.46||Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).|||1.46|0.71|0.9426
70927411|NCT04447469|141349554|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.6838|TWO_SIDED|80.0|0.78|1.57||Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).|||1.57|0.78|0.6838
70927412|NCT04447469|141349555|SUPERIORITY||Odds Ratio (OR)|0.235||||0.0905|TWO_SIDED|95.0|0.023|1.328|||Fisher Exact|||||1.328|0.023|0.0905
70927413|NCT04447469|141349555|SUPERIORITY||Odds Ratio (OR)|0.431||||0.2247|TWO_SIDED|95.0|0.087|1.815|||Fisher Exact|||||1.815|0.087|0.2247
70927414|NCT04447469|141349555|SUPERIORITY||Stratified Odds Ratio|0.191||||0.0623|TWO_SIDED|95.0|0.033|1.114||P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (standard of care antiretroviral therapy, age, and ARDS status).|Cochran-Mantel-Haenszel|||||1.114|0.033|0.0623
70927415|NCT04447469|141349555|SUPERIORITY||Stratified Odds Ratio|0.368||||0.1957|TWO_SIDED|95.0|0.085|1.583||P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (standard of care antiretroviral therapy, age, and ARDS status).|Cochran-Mantel-Haenszel|||||1.583|0.085|0.1957
70927416|NCT04447469|141349556|SUPERIORITY||Hazard Ratio (HR)|1.57||||0.3766|TWO_SIDED|80.0|0.8|3.09||Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, and age).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (Standard of Care antiretroviral therapy and age).|||3.09|0.80|0.3766
70927417|NCT04447469|141349556|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.9209|TWO_SIDED|80.0|0.51|2.16||Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, and age).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (Standard of Care antiretroviral therapy and age).|||2.16|0.51|0.9209
71010019|NCT03091920|141526977|OTHER|No statistical testing was performed.|Least squares mean difference|4.54|STANDARD_ERROR_OF_MEAN|1.58|||TWO_SIDED|95.0|1.27|7.81|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 7||7.81|1.27|
71010020|NCT03091920|141526977|OTHER|No statistical testing was performed.|Least squares mean difference|2.58|STANDARD_ERROR_OF_MEAN|1.94|||TWO_SIDED|95.0|-1.45|6.61|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||6.61|-1.45|
70927418|NCT04447469|141349557|SUPERIORITY||Stratified Odds Ratio|0.645||||0.1772|TWO_SIDED|95.0|0.34|1.222||Calculated using Cochran Mantel-Haenszel test, stratified by randomization strata (age and ARDS status).|Cochran-Mantel-Haenszel|||||1.222|0.340|0.1772
70927419|NCT04447469|141349557|SUPERIORITY||Stratified Odds Ratio|1.029||||0.9269|TWO_SIDED|95.0|0.563|1.881||Calculated using Cochran Mantel-Haenszel test, stratified by randomization strata (age and ARDS status).|Cochran-Mantel-Haenszel|||||1.881|0.563|0.9269
70927420|NCT04447469|141349558|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9578|TWO_SIDED|95.0|0.66|1.49||Log-rank test is stratified by randomization strata (age, and ARDS status).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (age and ARDS status).|||1.49|0.66|0.9578
70927421|NCT04447469|141349558|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.5274|TWO_SIDED|95.0|0.76|1.7||Log-rank test is stratified by randomization strata (age, and ARDS status).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (age and ARDS status).|||1.70|0.76|0.5274
70927422|NCT04447469|141349559|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.1336|TWO_SIDED|95.0|0.36|1.15||Log-rank test is stratified by randomization strata (age, and ARDS status).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (age, and ARDS status).|||1.15|0.36|0.1336
70927423|NCT04447469|141349559|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9767|TWO_SIDED|95.0|0.59|1.72||Log-rank test is stratified by randomization strata (age, and ARDS status).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata ( age, and ARDS status).|||1.72|0.59|0.9767
71010021|NCT03091920|141526977|OTHER|No statistical testing was performed.|Least squares mean difference|3.17|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|95.0|-0.78|7.11|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||7.11|-0.78|
70927424|NCT04447469|141349560|SUPERIORITY||Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|0.55|3.71|||||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (age).|||3.71|0.55|
70927425|NCT04447469|141349560|SUPERIORITY||Hazard Ratio (HR)|1.88|||||TWO_SIDED|95.0|0.78|4.54|||||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (age).|||4.54|0.78|
71010022|NCT03091920|141526977|OTHER|No statistical testing was performed.|Least squares mean difference|2.87|STANDARD_ERROR_OF_MEAN|1.72|||TWO_SIDED|95.0|-0.71|6.45|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 14||6.45|-0.71|
71046258|NCT01553747|141600662|SUPERIORITY||||||<|0.001||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||<0.001
70927426|NCT05201079|141349561|SUPERIORITY||Odds Ratio (OR)|2.395||||0.228|TWO_SIDED|97.79|0.54|10.624||Alpha: 0.0221|Regression, Logistic||Numerator: fidaxomicin; denominator: MBK-01|||10.624|0.540|0.228
70927427|NCT05201079|141349567|SUPERIORITY|||||||||||||||||Alpha value used: 0.0221|Statistical analysis using Odds Ratio cannot be performed because there are zero patients with bad progress in MBK-01 group.|||
70927428|NCT05201079|141349568|SUPERIORITY||Score (logrank) test|1.25||||0.3|TWO_SIDED|||||Alpha: 0.0221|Regression, Cox|Degrees of freedom: 1||||||0.300
70927429|NCT05201079|141349570|SUPERIORITY||Score (logrank) test|0.02||||0.9|TWO_SIDED|||||Alpha: 0.0221|Regression, Cox|Degrees of freedom: 1||||||0.900
70927430|NCT05201079|141349581|SUPERIORITY|||||||0.749||||||Main effect of the Group for the Physical Function area of the SF-36 questionnaire. F statistic (1,56) = 0.104.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.749
70927431|NCT05201079|141349581|SUPERIORITY|||||||0.62||||||Main effect of the Visit for the Physical Function area of the SF-36 questionnaire. F statistic (1,56) = 0.249.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.620
70927432|NCT05201079|141349581|SUPERIORITY|||||||0.16||||||Main effect of the Group x Visit interaction for the Physical Function area of the SF-36 questionnaire. F statistic (1,56) = 2.024.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.160
70927433|NCT05201079|141349581|SUPERIORITY|||||||0.614||||||Main effect of the Group for the Bodily pain area of the SF-36 questionnaire. F statistic (1,56) = 0.257.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.614
70927434|NCT05201079|141349581|SUPERIORITY|||||||0.007||||||Main effect of the Visit for the Bodily pain area of the SF-36 questionnaire. F statistic (1,56) = 7.705. Effect size = 0.046.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.007
70927435|NCT05201079|141349581|SUPERIORITY|||||||0.718||||||Main effect of the Group x Visit interaction for the Bodily pain area of the SF-36 questionnaire. F statistic (1,56) = 0.132.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.718
70927436|NCT05201079|141349581|SUPERIORITY|||||||0.494||||||Main effect of the Group for the General Health area of the SF-36 questionnaire. F statistic (1,56) = 0.474.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.494
70927437|NCT05201079|141349581|SUPERIORITY|||||||0.339||||||Main effect of the Visit for the General Health area of the SF-36 questionnaire. F statistic (1,56) = 0.932.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.339
71046259|NCT01553747|141600662|SUPERIORITY||||||<|0.001||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||<0.001
71046260|NCT01553747|141600663|SUPERIORITY|||||||0.001||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||0.001
70927438|NCT05201079|141349581|SUPERIORITY|||||||0.38||||||Main effect of the Group x Visit interaction for the General health area of the SF-36 questionnaire. F statistic (1,56) = 0.783.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.380
70927439|NCT05201079|141349581|SUPERIORITY|||||||0.79||||||Main effect of the Group for the Vitality area of the SF-36 questionnaire. F statistic (1,56) = 0.072|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.790
70927440|NCT05201079|141349581|SUPERIORITY|||||||0.498||||||Main effect of the Visit for the Vitality area of the SF-36 questionnaire. F statistic (1,56) = 0.465.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.498
70927441|NCT05201079|141349581|SUPERIORITY|||||||0.023||||||Main effect of the Group x Visit interaction for the Vitality area of the SF-36 questionnaire. F statistic (1,56) = 5.490.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.023
70927442|NCT05201079|141349581|SUPERIORITY|||||||0.553||||||Main effect of the Group for the Social role area of the SF-36 questionnaire. F statistic (1,56) = 0.356.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.553
71010023|NCT03091920|141526978|OTHER|No statistical testing was performed.|Least squares mean difference|2.17|STANDARD_ERROR_OF_MEAN|2.32|||TWO_SIDED|95.0|-2.65|6.99|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||6.99|-2.65|
71010024|NCT03091920|141526978|OTHER|No statistical testing was performed.|Least squares mean difference|4.09|STANDARD_ERROR_OF_MEAN|2.33|||TWO_SIDED|95.0|-0.73|8.91|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||8.91|-0.73|
70927443|NCT05201079|141349581|SUPERIORITY|||||||0.718||||||Main effect of the Visit for the Social role area of the SF-36 questionnaire. F statistic (1,56) = 0.132.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.718
70927444|NCT05201079|141349581|SUPERIORITY|||||||0.574||||||Main effect of the Group x Visit interaction for the Social role area of the SF-36 questionnaire. F statistic (1,56) = 0.319.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.574
70927445|NCT05201079|141349581|SUPERIORITY|||||||0.49||||||Main effect of the Group for the Emotional role area of the SF-36 questionnaire. F statistic (1,56) = 0.482.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.490
70927446|NCT05201079|141349581|SUPERIORITY|||||||0.032||||||Main effect of the Visit for the Emotional role area of the SF-36 questionnaire. F statistic (1,56) = 4.850|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.032
70927447|NCT05201079|141349581|SUPERIORITY|||||||0.145||||||Main effect of the Group x Visit interaction for the Emotional role area of the SF-36 questionnaire. F statistic (1,56) = 2.181.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.145
70927448|NCT05201079|141349581|SUPERIORITY|||||||0.467||||||Main effect of the Group for the Mental health area of the SF-36 questionnaire. F statistic (1,56) = 0.535.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.467
70927449|NCT05201079|141349581|SUPERIORITY|||||||0.1||||||Main effect of the Visit for the Mental health area of the SF-36 questionnaire. F statistic (1,56) = 2.795|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.100
70927450|NCT05201079|141349581|SUPERIORITY|||||||0.89||||||Main effect of the Group x Visit interaction for the Mental health area of the SF-36 questionnaire. F statistic (1,56) = 0.019.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.890
71010025|NCT03091920|141526978|OTHER|No statistical testing was performed.|Least squares mean difference|4.56|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|0.6|8.51|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||8.51|0.60|
71010026|NCT03091920|141526978|OTHER|No statistical testing was performed.|Least squares mean difference|4.02|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|0.07|7.98|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||7.98|0.07|
70927451|NCT05201079|141349581|SUPERIORITY|||||||0.742||||||Main effect of the Group for the Physical Role area of the SF-36 questionnaire. F statistic (1,56) = 0.109.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.742
70927452|NCT05201079|141349581|SUPERIORITY||||||<|0.001||||||Main effect of the Visit for the Physical Role area of the SF-36 questionnaire. F statistic (1,56) = 21.912. Effect size = 0.109.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||<0.001
70927453|NCT05201079|141349581|SUPERIORITY|||||||0.089||||||Main effect of the Group x Visit interaction for the Physical Role area of the SF-36 questionnaire. F statistic (1,56) = 2.986.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.089
70927454|NCT04752709|141349627|OTHER||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.0001
70927455|NCT05692960|141349727|SUPERIORITY|For this feasibility study, a sample of approximately 15 participants per arm will allow for estimates that can be used in the development of a larger study.|FSFI Total, HRI Cohen's d|1.37|||||TWO_SIDED|95.0|0.62|2.1||||||Effect sizes, Cohen's d, were calculated for both study arms using paired t-tests for FSFI total, FSFI lubrication, FSFI pain, and FSFI desire subscales. Means and 95% confidence intervals were also calculated.||2.10|.62|
70927456|NCT05692960|141349727|SUPERIORITY||FSFI Total, VVA Cohen's d|1.63|||||TWO_SIDED|95.0|0.86|2.37||||||||2.37|.86|
70927457|NCT05692960|141349727|SUPERIORITY||FSFI Lubrication, HRI Cohen's d|1.2|||||TWO_SIDED|95.0|0.49|1.87||||||||1.87|.49|
70927458|NCT05692960|141349727|SUPERIORITY||FSFI Lubrication, VVA Cohen's d|1.85|||||TWO_SIDED|95.0|1.02|2.66||||||||2.66|1.02|
70927459|NCT05692960|141349727|SUPERIORITY||FSFI Pain, HRI Cohen's d|0.77|||||TWO_SIDED|95.0|0.16|1.36||||||||1.36|.16|
70927460|NCT05692960|141349727|SUPERIORITY||FSFI Pain, VVA Cohen's d|0.82|||||TWO_SIDED|95.0|0.24|1.38||||||||1.38|.24|
70927461|NCT05692960|141349727|SUPERIORITY||FSFI Desire, HRI Cohen's d|1.15|||||TWO_SIDED|95.0|0.46|1.82||||||||1.82|.46|
70927462|NCT05692960|141349727|SUPERIORITY||FSFI Desire, VVA Cohen's d|1.21|||||TWO_SIDED|95.0|0.55|1.86||||||||1.86|.55|
70927463|NCT05692960|141349728|SUPERIORITY|For this feasibility study, a sample of approximately 15 participants per arm will allow for estimates that can be used in the development of a larger study.|BITS, HRI Cohen's d|1.0|||||TWO_SIDED|95.0|0.34|1.63||||||Effect sizes, Cohen's d, were calculated for both study arms using paired t-tests for the BITS. Means and 95% confidence intervals were also calculated.||1.63|.34|
70927464|NCT05692960|141349728|SUPERIORITY||BITS, VVA Cohen's d|0.5|||||TWO_SIDED|95.0|0.03|1.01||||||||1.01|.03|
70927465|NCT05692960|141349729|SUPERIORITY|For this feasibility study, a sample of approximately 15 participants per arm will allow for estimates that can be used in the development of a larger study.|PROMIS Interest, HRI Cohen's d|1.1|||||TWO_SIDED|95.0|0.41|1.75||||||Effect sizes, Cohen's d, were calculated for both study arms using paired t-test for PROMIS interest, lubrication and satisfaction subscales. Means and 95% confidence intervals were also calculated.||1.75|.41|
70927466|NCT05692960|141349729|SUPERIORITY||PROMIS Interest, VVA Cohen's d|0.64|||||TWO_SIDED|95.0|0.09|1.18||||||||1.18|.09|
70927467|NCT05692960|141349729|SUPERIORITY||PROMIS Satisfaction, HRI Cohen's d|1.19|||||TWO_SIDED|95.0|0.45|1.89||||||||1.89|.45|
70927468|NCT05692960|141349729|SUPERIORITY||PROMIS Satisfaction, VVA Cohen's d|0.8|||||TWO_SIDED|95.0|0.13|1.44||||||||1.44|.13|
71046261|NCT01553747|141600663|SUPERIORITY||||||<|0.001||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||<0.001
70927469|NCT05692960|141349729|SUPERIORITY||PROMIS Lubrication, HRI Cohen's d|1.79|||||TWO_SIDED|95.0|0.88|2.67||||||||2.67|.88|
70927470|NCT05692960|141349729|SUPERIORITY||PROMIS Lubrication, VVA Cohen's d|1.63|||||TWO_SIDED|95.0|0.74|2.5||||||||2.50|.74|
70927471|NCT04719832|141349730|SUPERIORITY|Analysis performed using a negative binomial model with covariates of treatment, exacerbation history (2, 3, 4+), baseline inhaled CS dose (medium, high), geographical region, baseline percent predicted Forced Expiratory Volume in one second (FEV1), and offset of log (total time in the study in years).|Rate Ratio|0.42|||<|0.001|TWO_SIDED|95.0|0.3|0.59|||Negative binomial distribution|||To demonstrate the superiority of GSK3511294 100 mg SC + SoC following two doses (at Week 0 and at Week 26) compared with placebo + SoC, assessed by the annualized rate of clinically significant exacerbations measured over the study intervention period of 52 weeks.||0.59|0.30|< 0.001
70927472|NCT04719832|141349731|SUPERIORITY||Difference in Least Square Means|-3.36|||=|0.08|TWO_SIDED|95.0|-7.11|0.39|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline SGRQ total score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline SGRQ total score and visit by treatment group||0.39|-7.11|= 0.080
70927473|NCT04719832|141349732|SUPERIORITY||Difference in Least Square Means|-0.04|||=|0.69|TWO_SIDED|95.0|-0.27|0.18|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ACQ-5 score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ACQ-5 score and visit by treatment group.||0.18|-0.27|= 0.690
70927474|NCT04719832|141349733|SUPERIORITY||Difference in Least Square Means|-0.001|||=|0.991|TWO_SIDED|95.0|-0.089|0.088|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline pre-bronchodilator FEV1, visit, visit by baseline pre-bronchodilator FEV1 and visit by treatment group.||0.088|-0.089|= 0.991
70927475|NCT04719832|141349734|SUPERIORITY||Difference in Least Square Means|-0.09|||=|0.65|TWO_SIDED|95.0|-0.5|0.31|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ANSD weekly mean score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ANSD weekly mean score and visit by treatment group.||0.31|-0.50|= 0.650
70927476|NCT04719832|141349735|SUPERIORITY||Difference in Least Square Means|-0.08|||=|0.647|TWO_SIDED|95.0|-0.42|0.26|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ADSD weekly mean score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ADSD weekly mean score and visit by treatment group.||0.26|-0.42|= 0.647
70927477|NCT04382664|141349737|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.845|TWO_SIDED|80.0|0.694|1.309|||Regression, Cox|||||1.309|0.694|0.845
70927478|NCT04898673|141349757|SUPERIORITY||Mean Difference (Final Values)|-5.23|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-6.08|-4.37|||ANOVA|||||-4.37|-6.08|<0.001
70927479|NCT04898673|141349758|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|1.39||0.67|TWO_SIDED|95.0|-2.31|3.51|||ANOVA|||||3.51|-2.31|0.670
71046262|NCT00754494|141600690|SUPERIORITY_OR_OTHER|||||||0.762|TWO_SIDED||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.762
71103478|NCT00863304|141714821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.24||0.101|TWO_SIDED|95.0|-0.85|0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.08|-0.85|0.101
70927480|NCT04898673|141349759|NON_INFERIORITY|Non-inferiority margin=-10% words correct; CP1110 non-inferior to CP1000 if the lower limit of the confidence interval for the difference \> -10% words correct.|Mean Difference (Final Values)|-3.75|STANDARD_ERROR_OF_MEAN|1.55||0.026|TWO_SIDED|95.0|-7.0|-0.5|||ANOVA|||||-0.50|-7.00|0.026
70927481|NCT04898673|141349760|NON_INFERIORITY|Non-inferiority margin=-10% words correct; CP1110 non-inferior to CP1000 if the lower limit of the confidence interval for the difference \> -10% words correct.|Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|1.37||0.411|TWO_SIDED|95.0|-4.02|1.72|||ANOVA|||||1.72|-4.02|0.411
71010027|NCT03091920|141526978|OTHER|No statistical testing was performed.|Least squares mean difference|3.12|STANDARD_ERROR_OF_MEAN|2.05|||TWO_SIDED|95.0|-1.15|7.39|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||7.39|-1.15|
71010028|NCT03091920|141526978|OTHER|No statistical testing was performed.|Least squares mean difference|3.74|STANDARD_ERROR_OF_MEAN|2.01|||TWO_SIDED|95.0|-0.44|7.92|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||7.92|-0.44|
71010029|NCT03091920|141526979|OTHER|No statistical testing was performed.|Least squares mean difference|4.3|STANDARD_ERROR_OF_MEAN|1.54|||TWO_SIDED|95.0|1.1|7.49|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||7.49|1.10|
71010030|NCT03091920|141526979|OTHER|No statistical testing was performed.|Least squares mean difference|2.94|STANDARD_ERROR_OF_MEAN|1.53|||TWO_SIDED|95.0|-0.23|6.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||6.10|-0.23|
71010031|NCT03091920|141526979|OTHER|No statistical testing was performed.|Least squares mean difference|4.8|STANDARD_ERROR_OF_MEAN|2.07|||TWO_SIDED|95.0|0.5|9.11|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||9.11|0.50|
71010032|NCT03091920|141526979|OTHER|No statistical testing was performed.|Least squares mean difference|5.1|STANDARD_ERROR_OF_MEAN|2.05|||TWO_SIDED|95.0|0.84|9.36|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||9.36|0.84|
71010033|NCT03091920|141526979|OTHER|No statistical testing was performed.|Least squares mean difference|1.89|STANDARD_ERROR_OF_MEAN|2.32|||TWO_SIDED|95.0|-2.93|6.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||6.70|-2.93|
71010034|NCT03091920|141526979|OTHER|No statistical testing was performed.|Least squares mean difference|2.55|STANDARD_ERROR_OF_MEAN|2.26|||TWO_SIDED|95.0|-2.15|7.25|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||7.25|-2.15|
71010035|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|6.81|STANDARD_ERROR_OF_MEAN|2.61|||TWO_SIDED|95.0|1.4|12.22|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||12.22|1.40|
70927482|NCT03899259|141349761|SUPERIORITY||Odds Ratio (OR)|7.86|||<|0.001|TWO_SIDED|95.0|2.79|22.17|||Regression, Logistic|||||22.17|2.79|<0.001
70927483|NCT03899259|141349761|SUPERIORITY||Odds Ratio (OR)|19.72|||<|0.001|TWO_SIDED|95.0|7.3|53.3|||Regression, Logistic|||||53.30|7.30|<0.001
70927484|NCT03899259|141349762|SUPERIORITY||Mean Difference (Final Values)|-25.25|STANDARD_ERROR_OF_MEAN|3.834|<|0.001|TWO_SIDED|95.0|-32.78|-17.72|||ANCOVA|||||-17.72|-32.78|<0.001
70927485|NCT03899259|141349762|SUPERIORITY||Mean Difference (Final Values)|-44.49|STANDARD_ERROR_OF_MEAN|3.482|<|0.001|TWO_SIDED|95.0|-51.33|-37.65|||ANCOVA|||||-37.65|-51.33|<0.001
70927486|NCT03899259|141349763|SUPERIORITY||Odds Ratio (OR)|4.63||||0.005|TWO_SIDED|95.0|1.58|13.6|||Regression, Logistic|||||13.60|1.58|0.005
70927487|NCT03899259|141349763|SUPERIORITY||Odds Ratio (OR)|12.94|||<|0.001|TWO_SIDED|95.0|4.72|35.44|||Regression, Logistic|||||35.44|4.72|<0.001
70927488|NCT03899259|141349764|SUPERIORITY||Odds Ratio (OR)|4.36||||0.001|TWO_SIDED|95.0|1.77|10.74|||Regression, Logistic|||||10.74|1.77|0.001
70927489|NCT03899259|141349764|SUPERIORITY||Odds Ratio (OR)|13.37|||<|0.001|TWO_SIDED|95.0|5.75|31.1|||Regression, Logistic|||||31.10|5.75|<0.001
71010036|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|6.55|STANDARD_ERROR_OF_MEAN|2.62|||TWO_SIDED|95.0|1.12|11.99|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||11.99|1.12|
71010037|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|-0.95|STANDARD_ERROR_OF_MEAN|3.49|||TWO_SIDED|95.0|-8.18|6.28|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||6.28|-8.18|
71010038|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|1.85|STANDARD_ERROR_OF_MEAN|3.49|||TWO_SIDED|95.0|-5.39|9.09|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||9.09|-5.39|
71010039|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|-0.38|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-5.98|5.23|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||5.23|-5.98|
71010040|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|3.1|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-2.5|8.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||8.70|-2.50|
71010041|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|6.46|STANDARD_ERROR_OF_MEAN|2.14|||TWO_SIDED|95.0|2.02|10.89|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||10.89|2.02|
70927490|NCT03899259|141349766|SUPERIORITY||Odds Ratio (OR)|2.56||||0.076|TWO_SIDED|95.0|0.91|7.24|||Regression, Logistic|||||7.24|0.91|0.076
71010042|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|5.57|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|95.0|1.19|9.95|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||9.95|1.19|
70927491|NCT03899259|141349766|SUPERIORITY||Odds Ratio (OR)|10.3|||<|0.001|TWO_SIDED|95.0|4.12|25.77|||Regression, Logistic|||||25.77|4.12|<0.001
70927492|NCT03899259|141349767|SUPERIORITY||Odds Ratio (OR)|1.88||||0.26|TWO_SIDED|95.0|0.63|5.62|||Regression, Logistic|||||5.62|0.63|0.260
70927493|NCT03899259|141349767|SUPERIORITY||Odds Ratio (OR)|8.1|||<|0.001|TWO_SIDED|95.0|3.18|20.66|||Regression, Logistic|||||20.66|3.18|<0.001
70927494|NCT03899259|141349768|SUPERIORITY||Odds Ratio (OR)|3.43||||0.017|TWO_SIDED|95.0|1.25|9.4|||Regression, Logistic|||||9.40|1.25|0.017
70927495|NCT03899259|141349768|SUPERIORITY||Odds Ratio (OR)|10.85|||<|0.001|TWO_SIDED|95.0|4.32|27.25|||Regression, Logistic|||||27.25|4.32|<0.001
70927496|NCT03899259|141349769|SUPERIORITY||Odds Ratio (OR)|14.63||||0.002|TWO_SIDED|95.0|2.73|78.42|||Regression, Logistic|||||78.42|2.73|0.002
70927497|NCT03899259|141349769|SUPERIORITY||Odds Ratio (OR)|30.37|||<|0.001|TWO_SIDED|95.0|5.93|99.99|||Regression, Logistic|||||99.99|5.93|<0.001
70927498|NCT03899259|141349770|SUPERIORITY||Mean Difference (Final Values)|-3.02|STANDARD_ERROR_OF_MEAN|1.981||0.129|TWO_SIDED|95.0|-6.91|0.88|||ANCOVA|||||0.88|-6.91|0.129
70927499|NCT03899259|141349770|SUPERIORITY||Mean Difference (Final Values)|-4.21|STANDARD_ERROR_OF_MEAN|1.799||0.02|TWO_SIDED|95.0|-7.75|-0.68|||ANCOVA|||||-0.68|-7.75|0.020
70927500|NCT03899259|141349771|SUPERIORITY||Mean Difference (Final Values)|-6.75|STANDARD_ERROR_OF_MEAN|3.017||0.026|TWO_SIDED|95.0|-12.68|-0.82|||ANCOVA|||||-0.82|-12.68|0.026
70927501|NCT03899259|141349771|SUPERIORITY||Mean Difference (Final Values)|-13.42|STANDARD_ERROR_OF_MEAN|2.737|<|0.001|TWO_SIDED|95.0|-18.8|-8.04|||ANCOVA|||||-8.04|-18.80|<0.001
70927502|NCT03899259|141349772|SUPERIORITY||Mean Difference (Final Values)|-4.38|STANDARD_ERROR_OF_MEAN|2.68||0.103|TWO_SIDED|95.0|-9.65|0.88|||ANCOVA|||||0.88|-9.65|0.103
70927503|NCT03899259|141349772|SUPERIORITY||Mean Difference (Final Values)|-8.33|STANDARD_ERROR_OF_MEAN|2.429|<|0.001|TWO_SIDED|95.0|-13.1|-3.56|||ANCOVA|||||-3.56|-13.10|<0.001
70927504|NCT03899259|141349773|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.315||0.518|TWO_SIDED|95.0|-0.82|0.42|||ANCOVA|||||0.42|-0.82|0.518
70927505|NCT03899259|141349773|SUPERIORITY||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.286||0.012|TWO_SIDED|95.0|-1.28|-0.16|||ANCOVA|||||-0.16|-1.28|0.012
71010043|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|3.63|STANDARD_ERROR_OF_MEAN|1.59|||TWO_SIDED|95.0|0.34|6.91|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||6.91|0.34|
70927506|NCT03899259|141349774|SUPERIORITY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.291||0.083|TWO_SIDED|95.0|-1.08|0.07|||ANCOVA|||||0.07|-1.08|0.083
70927507|NCT03899259|141349774|SUPERIORITY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.264||0.01|TWO_SIDED|95.0|-1.2|-0.16|||ANCOVA|||||-0.16|-1.20|0.010
70927508|NCT05670587|141349791|OTHER||gMean ratio at Week 4|0.95|||||TWO_SIDED|95.0|0.76|1.18|||||"gMean ratios of CfB in CC/h were calculated from the log transformed values at each visit.~Geometric Coefficient of variation (gCV) = 84.59%"|Geometric mean (gMean) ratio of change from baseline (CfB) in cough count per hour (CC/h) at Week 4.||1.18|0.76|
70927509|NCT05670587|141349791|OTHER||gMean ratio at Week 8|0.84|||||TWO_SIDED|95.0|0.64|1.11|||||"gMean ratios of CfB in CC/h were calculated from the log transformed values at each visit.~Geometric coefficient of variation (gCV) = 115.62%"|Geometric mean (gMean) ratio of change from baseline (CfB) in cough count per hour (CC/h) at Week 8.||1.11|0.64|
70927510|NCT05670587|141349791|OTHER||gMean ratio at Day 82|0.98|||||TWO_SIDED|95.0|0.75|1.29|||||"gMean ratios of CfB in CC/h were calculated from the log transformed values at each visit.~Geometric coefficient of variation (gCV) = 100.02%."|Geometric mean (gMean) ratio of change from baseline (CfB) in cough count per hour (CC/h) at Day 82.||1.29|0.75|
70927511|NCT05778695|141349799|OTHER|A comparison is not being made between two different treatment groups. Exploratory analysis|Median Difference (Net)|-14.0|STANDARD_DEVIATION|22.02||0.875|TWO_SIDED|||||A priori threshold for statistical significance is p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||0.875
70927512|NCT05778695|141349799|OTHER|A comparison is not being made between two different treatment groups. Exploratory analysis|Mean Difference (Net)|-2.0|STANDARD_DEVIATION|15.166||0.739|TWO_SIDED|95.0|-16.026|12.026||A priori threshold for statistical significance is p \< 0.05.|t-test, 2 sided|||||12.026|-16.026|0.739
70927513|NCT05778695|141349800|OTHER|A comparison is not being made between two different treatment groups. Exploratory analysis|Median Difference (Net)|0.0|STANDARD_DEVIATION|0.34||0.37|TWO_SIDED|||||A priori threshold for statistical significance is p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||0.37
70927514|NCT04625465|141349851|OTHER||Difference in the log odds ratios|0.042||||0.869|||||||Multilevel logistic regression|||"Multilevel logistic regression of daily IPV perpetration on alcohol use (Level 1) nested within participant (Level 2) with interaction between alcohol use and CBT Intervention.~Testing the difference in odds ratio between groups 1 (No Intervention and Attention Control ) and 2 (CBT Texts Intervention) H0: OR1 = OR2"||||.869
70927515|NCT04625465|141349852|OTHER||Difference in the log odds ratios|-0.32||||0.21|||||||Multilevel logistic regression|||"Multilevel logistic regression of daily IPV perpetration on alcohol use (Level 1) nested within participant (Level 2) with interaction between alcohol use and CBT Intervention.~Testing the difference in odds ratio between groups 1 (No Intervention and Attention Control ) and 2 (CBT Texts Intervention) H0: OR1 = OR2"||||.210
70927516|NCT05566639|141349872|NON_INFERIORITY|Noninferiority margin = 10%|Relative vaccine efficacy (rVE)|1.7||||0.1715|TWO_SIDED|95.0|-24.1|22.2|||Stratified Cox proportional hazards||rVE = 100 \* (1 - HR) % was defined as the percent reduction in the hazard (mRNA-1010 vs active comparator), where HR was the hazard ratio between mRNA-1010 vs the active comparator.|||22.2|-24.1|0.1715
70927517|NCT05239455|141349890|OTHER|The FDA requires one-sided 95% lower confidence limit for the population proportion of success is greater than 70% where success of a unit is defined as the RBC in vivo 24-hour percentage recovery ≥ 75%. Allows for low recoveries (\<75%) in 2/20 or 3/24 volunteers.|95% Confidence Interval|88.5|||||ONE_SIDED|95.0|72.81||||||A one-sided confidence interval for the proportion of successes was determined using the Clopper-Pearson exact method for a 95% confidence interval.|The comparison is to the FDA requirements for in vivo 24-hour recovery of LR-RBC.|Proportion of successes greater than 70% where success of a unit is defined as the RBC in vivo 24-hour percentage recovery ≥ 75% was calculated.||72.81|
70927518|NCT05239455|141349891|OTHER|The FDA criteria requires LR-RBC mean 24-hour recovery ≥ 75% with standard deviation (SD) ≤ 9%||||||||||||||||The comparison is to the FDA requirements for in vivo 24-hour recovery of LR-RBC.|Mean and standard deviation were calculated.|||
70927519|NCT04159415|141349908|SUPERIORITY||Least Squares (LS) Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-1.8|2.4|||||Confidence interval (CI) based on treatment group difference (R4461 Low dose vs. placebo) of the LS means using mixed-effect model with repeated measures (MMRM) model|||2.4|-1.8|
70927520|NCT04159415|141349909|SUPERIORITY||LS Mean Difference|38.1|STANDARD_ERROR_OF_MEAN|27.3|||TWO_SIDED|95.0|-21.3|97.5|||||Confidence interval (CI) based on treatment group difference (R4461 Low dose vs. placebo) of the LS means using mixed-effect model with repeated measures (MMRM) model|||97.5|-21.3|
70927521|NCT04159415|141349910|SUPERIORITY||Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|29.0|||TWO_SIDED|95.0|-56.9|56.9|||||Combined estimate for adjusted mean difference (SE) vs Placebo obtained by combining adjusted means and SE from ANCOVA model analyses of the different imputed data sets.|||56.9|-56.9|
70927522|NCT04159415|141349911|SUPERIORITY||Adjusted Mean Difference|17.8|STANDARD_ERROR_OF_MEAN|43.6|||TWO_SIDED|95.0|-67.6|103.2|||||Combined estimate for adjusted mean difference (SE) vs Placebo obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets.|||103.2|-67.6|
70927523|NCT01799265|141349928|NON_INFERIORITY|The 95% upper limit of the prediction interval was calculated using the formula (μ ) ̂+t\_(k-2)\^α √((τ\^2 ) ̂+〖(SE) ̂(μ ̂ )〗\^2 ),where (μ ) ̂is the estimate average AHI across all studies, (τ\^2 ) ̂ is the between-study variation, t\_(k-2)\^α is the critical value for a t-distribution, k is the number of studies in the meta-analysis, and k-2 are the degrees of freedom for the t distribution. Meta-analyzed statistics to compute the prediction interval were (μ ) ̂=5.0, SE(μ ̂ )=0.9, and (τ\^2 ) ̂=8.0||||||0.05|||||||t-test, 1 sided|A p-value of .05 was used.||"Hypothesis testing for the primary endpoint was conducted using a one-sided test of non-inferiority with the following null and alternative hypotheses at the 0.05 significance level using the MIXED procedure in SAS, version 9.3:~H\_0:(ϕ\_m ) ̂≥6.9 H\_A:(ϕ\_m ) ̂\<6.9 where (ϕ\_m ) ̂ is the estimated AHI difference between Transcend Auto and REMstar Auto from the model described in 3.5.1."||||.05
70927524|NCT06182033|141349939|OTHER|||||||0.84|||||||Regression, Linear|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||We conducted a linear regression. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.||||.84
70927525|NCT06182033|141349940|OTHER|||||||0.727|||||||Regression, Linear|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||We conducted a linear regression. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.||||.727
71046263|NCT00754494|141600690|SUPERIORITY_OR_OTHER|||||||0.125|TWO_SIDED||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.125
71046264|NCT00754494|141600690|SUPERIORITY_OR_OTHER|||||||0.855|TWO_SIDED||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.855
71046265|NCT00754494|141600691|SUPERIORITY_OR_OTHER|||||||0.369|TWO_SIDED||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.369
71046266|NCT00754494|141600691|SUPERIORITY_OR_OTHER|||||||0.085|TWO_SIDED||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.085
70927526|NCT06182033|141349941|OTHER|||||||0.205|||||||Regression, Linear|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||These analyses use the assertiveness subscale as the outcome variable. We conducted a linear regression for each of the measure's subscales. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.||||.205
70927527|NCT06182033|141349941|OTHER|||||||0.034|||||||Regression, Linear|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||This analysis focused specifically on the behavior control subscale. We conducted a linear regression for each of the measure's subscales. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.||||.034
70927528|NCT06182033|141349941|OTHER|||||||0.099|||||||Regression, Linear|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||These analyses use the Task Orientation subscale as the outcome variable. We conducted a linear regression for each of the measure's subscales. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.||||.099
71103479|NCT00863304|141714821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.7|-0.78||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.78|-1.70|<0.001
71103480|NCT00863304|141714821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.47|-0.54||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.54|-1.47|<0.001
70927529|NCT06182033|141349941|OTHER|||||||0.209|||||||Regression, Linear|||This analysis used peer social skills subscale as the outcome in the model. We conducted a linear regression for each of the measure's subscales. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.||||.209
70927530|NCT06182033|141349942|OTHER|||||||0.82|||||||Multilevel Model|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||We examined the trajectory across timepoints using a multilevel model that controlled for age. The p value is in reference to the difference between the treatment and control children at the final observation.||||.82
70927531|NCT06182033|141349943|OTHER|||||||0.67|||||||Multilevel Model|Kenward-Rogers and Restricted Maximum Likelihood adjustments in light of small sample size to reduce error likelihood.||We examined the trajectory across timepoints using a multilevel model that controlled for age. The p value is in reference to the difference between the treatment and control children at the final observation.||||.67
70927532|NCT06182033|141349944|OTHER|||||||0.024|||||||Regression, Linear|Kenward-Rogers and Restricted Maximum Likelihood to account for the small sample size.||We examined the trajectory across timepoints using a multilevel model that controlled for age. The p value is in reference to the difference between the treatment and control children at the final observation.||||.024
70927533|NCT06182033|141349945|OTHER|||||||0.013|||||||Regression, Linear|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||We examined the trajectory across timepoints using a multilevel model that controlled for age. The p value is in reference to the difference between the treatment and control children at the final observation.||||.013
70927534|NCT02364557|141349946|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.36|TWO_SIDED|70.0|0.71|1.17||One-side significance level = 0.15|Log Rank||Reference level = SOC arm|Assuming an increase in median PFS from 10.5 to 19 months (HR: 0.55), 69 events provide \>90% power to conclude superiority with 1-sided α = 0.15.||1.17|0.71|0.36
70927535|NCT02364557|141349949|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.91|TWO_SIDED|95.0|0.59|1.61||Two-sided significance level = 0.05|Gray's test||Reference level = SOC arm|||1.61|0.59|0.91
70927536|NCT02364557|141349951|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9|TWO_SIDED|95.0|0.54|2.02||Two-sided significance level = 0.05.|Log Rank||Reference level = CTCs Absent|||2.02|0.54|0.90
70927537|NCT04828005|141349990|NON_INFERIORITY|Alternative hypothesis: Nalmefene reversal not less than 80% naloxone reversal|||||<|0.0009|||||||Mixed Models Analysis|||||||<0.0009
70927538|NCT05530603|141350004|OTHER|||||||0.009||||||The threshold for statistical significance was p=0.05.|Chi-squared|||||||.009
70927539|NCT05530603|141350005|OTHER||Mean Difference (Net)|1.12|STANDARD_DEVIATION|0.8||0.73|TWO_SIDED|||||The threshold for statistical significance was p=0.05.|ANOVA|||||||0.730
70927540|NCT05530603|141350006|OTHER|||||||0.033||||||The threshold for statistical significance was p=0.05.|ANOVA|||||||.033
70927541|NCT05530603|141350007|OTHER|||||||0.068|||||||ANOVA|The threshold for statistical significance was p=0.05.||||||.068
70927542|NCT05530603|141350008|OTHER|||||||0.001||||||The threshold for statistical significance was p=0.05.|Fisher Exact|||||||.001
70927543|NCT05530603|141350009|OTHER|||||||0.001||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||||||.001
70927544|NCT05530603|141350010|OTHER|||||||0.001||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||||||.001
70927545|NCT02043678|141350011|SUPERIORITY||Hazard Ratio (HR)|1.122||||0.2636|TWO_SIDED|95.0|0.917|1.374|||Cox Proportional Hazards Model|||||1.374|0.917|0.2636
70927546|NCT02043678|141350012|SUPERIORITY||Hazard Ratio (HR)|1.151||||0.1194|TWO_SIDED|95.0|0.964|1.374|||Cox Proportional Hazards model|||||1.374|0.964|0.1194
71103481|NCT00863304|141714821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.24||0.009|TWO_SIDED|95.0|-1.08|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-1.08|0.009
70927547|NCT02043678|141350013|SUPERIORITY||Hazard Ratio (HR)|1.152||||0.1283|TWO_SIDED|95.0|0.96|1.383|||Cox Proportional Hazards Model|||||1.383|0.960|0.1283
70927548|NCT02043678|141350014|SUPERIORITY||Hazard Ratio (HR)|1.145||||0.1669|TWO_SIDED|95.0|0.945|1.389|||Cox Proportional Hazards Model|||||1.389|0.945|0.1669
70927549|NCT02043678|141350015|SUPERIORITY||Hazard Ratio (HR)|1.033||||0.7871|TWO_SIDED|95.0|0.816|1.308|||Cox Proportional Hazards Model|||||1.308|0.816|0.7871
70927550|NCT02043678|141350016|SUPERIORITY||Hazard Ratio (HR)|1.126||||0.2467|TWO_SIDED|95.0|0.921|1.378|||Cox Proportional Hazards Model|||||1.378|0.921|0.2467
70927551|NCT04568603|141350037|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to the methadone alone will be supported if the 90% CI for the geometric mean ratio (GMR) of methadone+ ISL to methadone alone is contained within the interval (0.70, 1.43).|GMR|1.03|||||TWO_SIDED|90.0|1.0|1.07||||||||1.07|1.00|
70927552|NCT04568603|141350038|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to the methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.03|||||TWO_SIDED|90.0|0.99|1.07||||||||1.07|0.99|
70927553|NCT04568603|141350039|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to the methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 1.43.|GMR|1.02|||||TWO_SIDED|90.0|0.96|1.09||||||||1.09|0.96|
70927554|NCT04568603|141350040|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.06|||||TWO_SIDED|90.0|1.03|1.1||||||||1.10|1.03|
70927555|NCT04568603|141350042|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.01|||||TWO_SIDED|90.0|0.94|1.09||||||||1.09|0.94|
70927556|NCT04568603|141350043|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.08|||||TWO_SIDED|90.0|1.04|1.13||||||||1.13|1.04|
71103482|NCT00863304|141714821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.24||0.008|TWO_SIDED|95.0|-1.08|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-1.08|0.008
70927557|NCT04568603|141350045|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.03|||||TWO_SIDED|90.0|0.99|1.07||||||||1.07|0.99|
70927558|NCT04568603|141350046|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.01|||||TWO_SIDED|90.0|0.95|1.08||||||||1.08|0.95|
70927559|NCT04568603|141350047|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.07|||||TWO_SIDED|90.0|1.03|1.11||||||||1.11|1.03|
70927560|NCT03313076|141350054|SUPERIORITY||Slope|-0.84||||0.276|TWO_SIDED|95.0|-2.32|0.63||"The final, adjusted p-value threshold of 0.0492, using the O'Brien-Fleming approach, allows for a statistical penalty to be assessed because of the interim analysis."|Mixed Models Analysis|The model was adjusted for age, sex, race, treatment interaction, initial pain severity, and total body surface area burned.||||0.63|-2.32|0.276
70927561|NCT03313076|141350054|SUPERIORITY||Slope|0.72||||0.336|TWO_SIDED|95.0|-0.71|2.14||"The final, adjusted p-value threshold of 0.0492, using the O'Brien-Fleming approach, allows for a statistical penalty to be assessed because of the interim analysis."|Mixed Models Analysis|The model was adjusted for age, sex, race, treatment interaction, initial pain severity, and total body surface area burned.||||2.14|-0.71|0.336
70927562|NCT03313076|141350054|SUPERIORITY||Slope|-2.33||||0.004|TWO_SIDED|95.0|-3.76|-0.9||"The final, adjusted p-value threshold of 0.0492, using the O'Brien-Fleming approach, allows for a statistical penalty to be assessed because of the interim analysis."|Mixed Models Analysis|The model was adjusted for age, sex, race, treatment interaction, initial pain severity, and total body surface area burned.||Sensitivity analysis adjusting for an influential observation (using the dfbeta approach) that could produce spurious results from a small trial dataset||-0.9|-3.76|0.004
70927563|NCT03313076|141350054|SUPERIORITY||Slope|0.92||||0.139|TWO_SIDED|95.0|-0.25|2.09||"The final, adjusted p-value threshold of 0.0492, using the O'Brien-Fleming approach, allows for a statistical penalty to be assessed because of the interim analysis."|Mixed Models Analysis|The model was adjusted for age, sex, race, treatment interaction, initial pain severity, and total body surface area burned.||Sensitivity analysis adjusting for an influential observation (using the dfbeta approach) that could produce spurious results from a small trial dataset||2.09|-0.25|0.139
70927564|NCT04119843|141350059|SUPERIORITY|Reader success for the primary analysis was achieved if the reading results demonstrated superiority of combined MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.95|STANDARD_DEVIATION|0.824|<|0.001|TWO_SIDED|95.0|0.743|1.165|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion border delineation mean difference (combined MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of combined MRI versus unenhanced MRI: Reader 1||1.165|0.743|<0.001
70927565|NCT04119843|141350059|SUPERIORITY|Reader success for the primary analysis was achieved if the reading results demonstrated superiority of combined MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.8|STANDARD_DEVIATION|0.892|<|0.001|TWO_SIDED|95.0|0.552|1.043|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion border delineation mean difference (combined MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of combined MRI versus unenhanced MRI: Reader 2||1.043|0.552|<0.001
70927566|NCT04119843|141350059|SUPERIORITY|Reader success for the primary analysis was achieved if the reading results demonstrated superiority of combined MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.65|STANDARD_DEVIATION|0.622|<|0.001|TWO_SIDED|95.0|0.494|0.813|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion border delineation mean difference (combined MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of combined MRI versus unenhanced MRI: Reader 3||0.813|0.494|<0.001
70927567|NCT04119843|141350060|SUPERIORITY|Reader success of the primary analysis was achieved if the reading results demonstrated superiority of combined MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.98|STANDARD_DEVIATION|0.853|<|0.001|TWO_SIDED|95.0|0.759|1.196|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion contrast mean difference (combined MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of combined MRI versus unenhanced MRI: Reader 1||1.196|0.759|<0.001
70927568|NCT04119843|141350060|SUPERIORITY|Reader success of the primary analysis was achieved if the reading results demonstrated superiority of combined MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|1.02|STANDARD_DEVIATION|0.909|<|0.001|TWO_SIDED|95.0|0.766|1.267|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion contrast mean difference (combined MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of combined MRI versus unenhanced MRI: Reader 2||1.267|0.766|<0.001
70941331|NCT00985621|141383146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.23||0.916|TWO_SIDED|95.0|-0.43|0.48|||ANCOVA|||Change at Week 2: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.48|-0.43|0.916
71046267|NCT00754494|141600691|SUPERIORITY_OR_OTHER|||||||0.233|TWO_SIDED||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.233
70927569|NCT04119843|141350060|SUPERIORITY|Reader success for the primary analysis was achieved if the reading results demonstrated superiority of combined MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.81|STANDARD_DEVIATION|0.678|<|0.001|TWO_SIDED|95.0|0.638|0.985|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion contrast mean difference (combined MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of combined MRI versus unenhanced MRI: Reader 3||0.985|0.638|<0.001
70927570|NCT04119843|141350062|SUPERIORITY|Reader success was achieved if the reading results demonstrated superiority of mangoral-enhanced MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.76|STANDARD_DEVIATION|0.805|<|0.001|TWO_SIDED|95.0|0.555|0.971|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion border delineation mean difference (mangoral-enhanced MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of mangoral-enhanced MRI versus unenhanced MRI: Reader 1||0.971|0.555|<0.001
70927571|NCT04119843|141350062|SUPERIORITY|Reader success was achieved if the reading results demonstrated superiority of mangoral-enhanced MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.76|STANDARD_DEVIATION|1.059|<|0.001|TWO_SIDED|95.0|0.464|1.054|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion border delineation mean difference (mangoral-enhanced MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of mangoral-enhanced MRI versus unenhanced MRI: Reader 2||1.054|0.464|<0.001
70927572|NCT04119843|141350062|SUPERIORITY|Reader success was achieved if the reading results demonstrated superiority of mangoral-enhanced MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.59|STANDARD_DEVIATION|0.609|<|0.001|TWO_SIDED|95.0|0.429|0.747|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion border delineation mean difference (mangoral-enhanced MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of mangoral-enhanced MRI versus unenhanced MRI: Reader 3||0.747|0.429|<0.001
70927573|NCT04119843|141350063|SUPERIORITY|Reader success was achieved if the reading results demonstrated superiority of mangoral-enhanced MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.95|STANDARD_DEVIATION|0.852|<|0.001|TWO_SIDED|95.0|0.726|1.166|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion contrast mean difference (mangoral-enhanced MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of mangoral-enhanced MRI versus unenhanced MRI: Reader 1||1.166|0.726|<0.001
70927574|NCT04119843|141350063|SUPERIORITY|Reader success was achieved if the reading results demonstrated superiority of mangoral-enhanced MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.73|STANDARD_DEVIATION|1.261|<|0.001|TWO_SIDED|95.0|0.38|1.082|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion contrast mean difference (mangoral-enhanced MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of mangoral-enhanced MRI versus unenhanced MRI: Reader 2||1.082|0.380|<0.001
70927575|NCT04119843|141350063|SUPERIORITY|Reader success was achieved if the reading results demonstrated superiority of mangoral-enhanced MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.72|STANDARD_DEVIATION|0.786|<|0.001|TWO_SIDED|95.0|0.517|0.927|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion contrast mean difference (mangoral-enhanced MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of mangoral-enhanced MRI versus unenhanced MRI: Reader 3||0.927|0.517|<0.001
70927576|NCT03904147|141350072|SUPERIORITY||Win Ratio|1.44||||0.0311|TWO_SIDED||||||Finkelstein-Schoenfeld Method||The Win Ratio provides an estimation of the treatment effect.|||||0.0311
70927577|NCT03904147|141350073|SUPERIORITY|||||||0.0008|||||||exact test|||||||0.0008
70927578|NCT03904147|141350074|SUPERIORITY||||||<|0.0001|||||||Z test|||||||<0.0001
70927579|NCT03904147|141350075|SUPERIORITY||||||<|0.0001|||||||ANCOVA model|||||||<0.0001
70927580|NCT03904147|141350076|SUPERIORITY||||||<|0.0001|||||||Chi-square test|||||||<0.0001
70927581|NCT03904147|141350077|SUPERIORITY|||||||0.2482|||||||ANCOVA model|||||||0.2482
70927582|NCT03904147|141350078|SUPERIORITY||||||<|0.0001|||||||Exact test|||||||<0.0001
70927583|NCT03904147|141350079|SUPERIORITY||||||<|0.0001|||||||Binomial exact method|||||||<0.0001
70927584|NCT03904147|141350080|SUPERIORITY|||||||0.109|||||||normal approximation|||||||0.1090
70927585|NCT05448105|141350231|SUPERIORITY|||||||0.02|||||||Wilcoxon signed rank test|"Wilcoxon signed rank test comparing the participants' SUS scores to the threshold value of 71 indicative of good usability."||||||0.02
70927586|NCT05448105|141350234|OTHER|||||||0.04|||||||paired Wilcoxon signed-rank sum test|||||||0.04
70927587|NCT05448105|141350235|OTHER||||||<|0.01||||||This is calculated p-value. The threshold for significance was less than 0.05.|paired Wilcoxon signed-rank sum test|||||||<0.01
70927588|NCT05448105|141350236|OTHER|||||||0.16|||||||paired Wilcoxon signed-rank sum test|||||||0.16
70927589|NCT05448105|141350237|OTHER|||||||0.69|||||||paired Wilcoxon signed-rank sum test|||||||0.69
70927590|NCT05448105|141350238|OTHER|||||||0.9|||||||paired Wilcoxon signed-rank sum test|||||||0.90
70927591|NCT05448105|141350239|OTHER|||||||0.11|||||||paired Wilcoxon signed-rank sum test|||||||0.11
70927592|NCT05448105|141350240|OTHER|||||||0.22|||||||paired Wilcoxon signed-rank sum test|||||||0.22
70927593|NCT05448105|141350241|OTHER|||||||1||||||This is the calculated p-value.|McNemar|||Analysis for pre-post change in knowledge of definition of A1C||||1.00
70927594|NCT05448105|141350241|OTHER|||||||0.55|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for hemoglobin A1c.||||0.55
70927595|NCT05448105|141350241|OTHER|||||||0.11|||||||McNemar|||Analysis for pre-post change in knowledge of definition of systolic blood pressure||||0.11
71103483|NCT00863304|141714821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.24||0.101|TWO_SIDED|95.0|-0.85|0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.08|-0.85|0.101
70927596|NCT05448105|141350241|OTHER|||||||0.63|||||||McNemar|||Analysis of pre-post change in knowledge of goal range for systolic blood pressure||||0.63
70927597|NCT05448105|141350241|OTHER|||||||0.12|||||||McNemar|||Analysis of pre-post change in knowledge of definition of LDL cholesterol||||0.12
70927598|NCT05448105|141350241|OTHER|||||||0.33|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for LDL cholesterol||||0.33
70927599|NCT05448105|141350241|OTHER|||||||0.23|||||||McNemar|||Analysis of pre-post change in knowledge of definition of urine microalbumin||||0.23
70927600|NCT05448105|141350241|OTHER|||||||0.58|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for urine microalbumin||||0.58
70927601|NCT05448105|141350241|OTHER|||||||1|||||||McNemar|||Analysis of pre-post change in knowledge of definition of body mass index (BMI)||||1.00
70927602|NCT05448105|141350241|OTHER|||||||0.27|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for body mass index (BMI)||||0.27
70927603|NCT04413708|141350246|SUPERIORITY||Risk Ratio (RR)|1.62||||0.41|TWO_SIDED|95.0|0.5|5.17|||Fisher Exact|||||5.17|0.50|0.41
70927604|NCT04413708|141350247|SUPERIORITY||Risk Ratio (RR)|1.07||||1|TWO_SIDED|95.0|0.61|1.9|||Fisher Exact|||||1.90|0.61|1.0
70927605|NCT03133546|141350290|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.84|TWO_SIDED|95.0|0.68|1.37||significance level: 5%|Regression, Cox|Univariate Cox for PFS with treatment effect only|The HR for Osimertinib plus Bevacizumab versus Osimertinib alone is provided.|"Assumption: Median PFS with osimertinib 11 months Target: Detect a 36% improvement in PFS (HR=0.64, corresponding to an increase in median PFS to 17.2 months) under osimertinib and bevacizumab (80% power, at one-sided significant level of 5%)~126 events required"||1.37|0.68|0.84
70927606|NCT00986856|141350314|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|13.2|||<|0.01||95.0|1.4|120.4||Test for the hypothesis of odds ratio equal to 1.|Cochran-Mantel-Haenszel|||||120.4|1.4|<0.01
70927607|NCT00986856|141350315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.7||||0.023||95.0|1.1|28.6|||Cochran-Mantel-Haenszel|||||28.6|1.1|0.023
70927608|NCT00986856|141350316|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.7||||0.54|TWO_SIDED|95.0|0.3|8.1|||Cochran-Mantel-Haenszel|||||8.1|0.3|0.54
70927609|NCT00986856|141350317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.7||||0.1|TWO_SIDED|95.0|0.8|8.8|||Cochran-Mantel-Haenszel|||||8.8|0.8|0.1
70927610|NCT00986856|141350318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Cochran-Mantel-Haenszel|||||||0.1
70927611|NCT00986856|141350319|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.5||||0.043||95.0|0.9|83.5|||Cochran-Mantel-Haenszel|||||83.5|0.9|0.043
70927612|NCT00986856|141350320|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|12.8||||0.007||95.0|1.5|109.6|||Cochran-Mantel-Haenszel|||||109.6|1.5|0.007
70927613|NCT00986856|141350321|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.8|STANDARD_DEVIATION|2.0||0.008||95.0|-4.8|-0.8|||Regression, Linear|||||-0.8|-4.8|0.008
70927614|NCT05386030|141350325|NON_INFERIORITY|The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB\> d0 where, pA is the response rate for saypha® VOLUME Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested based on Farrington-Manning-statistics with a one-sided type I error rate level of 0.025.|||||<|0.0001||||||Confirmatory testing will be performed in a hierarchical ordering: First analysis will be performed on the per protocol dataset, and if the corresponding p-value is below 0.025, the analysis will be performed on the full analysis dataset.|Farrington-Manning test|||||||<0.0001
70927615|NCT05386030|141350326|NON_INFERIORITY|The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB\> d0 where, pA is the response rate for saypha® VOLUME Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested based on Farrington-Manning-statistics with a one-sided type I error rate level of 0.025.|||||<|0.0001||||||Confirmatory testing will be performed in a hierarchical ordering: First analysis will be performed on the per protocol dataset, and if the corresponding p-value is below 0.025, the analysis will be performed on the full analysis dataset.|Farrington-Manning test|||||||<0.0001
70927616|NCT04324359|141350338|SUPERIORITY||||||<|0.001|||||||z-test for proportions|Other: z-test for proportions, 2-sided test at alpha = 5% level. P-value: based on the normal approximation test for differences between proportions.||||||<0.001
70927617|NCT04324359|141350339|SUPERIORITY|||||||0.066|||||||Other: z-test for proportions|Other: z-test for proportions, 2-sided test at alpha = 5% level. P-value: based on Barnard's exact test for differences between proportions.||||||0.066
70927618|NCT04324359|141350340|SUPERIORITY|||||||0.716|||||||z-test for proportions|Other: z-test for proportions, 2-sided test at alpha = 5% level. P-value: based on Barnard's exact test for differences between proportions.||||||0.716
70927619|NCT04324359|141350341|SUPERIORITY|||||||0.528|||||||z-test for proportions|Other: z-test for proportions, 2-sided test at alpha = 5% level P-value: based on Barnard's exact test for differences between proportions.||||||0.528
70927620|NCT04324359|141350342|SUPERIORITY|||||||0.766|||||||z-test for proportions|Other: z-test for proportions, 2-sided test at alpha = 5% level. P-value: based on Barnard's exact test for differences between proportions.||||||0.766
70927621|NCT04324359|141350343|SUPERIORITY|||||||0.619|||||||z-test for proportions|Other: z-test for proportions, 2-sided test at alpha = 5% level. P-value: based on Barnard's exact test for differences between proportions.||||||0.619
71103484|NCT00863304|141714821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.79|-0.83||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.83|-1.79|<0.001
71010044|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|2.41|STANDARD_ERROR_OF_MEAN|1.57|||TWO_SIDED|95.0|-0.84|5.66|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||5.66|-0.84|
71010045|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|1.74|STANDARD_ERROR_OF_MEAN|2.23|||TWO_SIDED|95.0|-2.89|6.36|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||6.36|-2.89|
71010046|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|0.33|STANDARD_ERROR_OF_MEAN|2.25|||TWO_SIDED|95.0|-4.33|4.99|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||4.99|-4.33|
70927622|NCT01733316|141350350|SUPERIORITY|||||||0.0048||||||Paired t-test testing the null hypothesis that the population average difference during the Cystagon® phase is equal to the population average difference during the RP103 phase.|Paired t-test, two-sided|||||||0.0048
71010047|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|4.36|STANDARD_ERROR_OF_MEAN|2.66|||TWO_SIDED|95.0|-1.17|9.88|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||9.88|-1.17|
70927623|NCT01674140|141350364|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.52|TWO_SIDED|95.0|0.77|1.14|||Log Rank|||||1.14|0.77|0.52
70927624|NCT01674140|141350365|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.84|TWO_SIDED|95.0|0.75|1.26|||Log Rank|||||1.26|0.75|0.84
70927625|NCT01674140|141350367|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.32|TWO_SIDED|95.0|0.74|1.1|||Log Rank|||||1.10|0.74|0.32
70927626|NCT02606422|141350377|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<.05
71010048|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|5.41|STANDARD_ERROR_OF_MEAN|2.68|||TWO_SIDED|95.0|-0.14|10.96|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||10.96|-0.14|
71046268|NCT00754494|141600692|SUPERIORITY_OR_OTHER|||||||0.651|TWO_SIDED||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.651
71010049|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|4.88|STANDARD_ERROR_OF_MEAN|2.18|||TWO_SIDED|95.0|0.36|9.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||9.40|0.36|
71010050|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|4.3|STANDARD_ERROR_OF_MEAN|2.18|||TWO_SIDED|95.0|-0.22|8.83|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||8.83|-0.22|
71010051|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|4.04|STANDARD_ERROR_OF_MEAN|2.26|||TWO_SIDED|95.0|-0.65|8.72|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||8.72|-0.65|
71046269|NCT00754494|141600692|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.030
70927627|NCT04731818|141350381|SUPERIORITY||Mean Difference (Final Values)|0.0001|||<|0.0001|TWO_SIDED|||||analyzed by 1-way repeated measures analysis of variance (ANOVA) with post hoc Tukey multiple comparison test|ANOVA|1 way repeated measures ANOVA||||||<0.0001
70927628|NCT02151981|141350383|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.3|||<|0.001|TWO_SIDED|95.0|0.23|0.41|||Log Rank||A hazard ratio \<1 favours Osimertinib 80mg|||0.41|0.23|<0.001
70927629|NCT02151981|141350384|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.39|||<|0.001|TWO_SIDED|95.0|3.47|8.48|||Regression, Logistic|adjusted for ethnicity (Asian/non-Asian)|odds ratio \>1.0 favours Osimertinib 80 mg|||8.48|3.47|<0.001
70927630|NCT02151981|141350385|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Expected (DoR)|6.22|||<|0.001|TWO_SIDED|95.0|4.04|9.57|||formulae provided in Ellis S et al 2008|Treatments compared by calculating the ratio of the Expected (DoR) using the Log Normal probability distribution for DOR in responding patients||||9.57|4.04|<0.001
70927631|NCT02151981|141350386|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.76|||<|0.001|TWO_SIDED|95.0|2.64|8.84|||Regression, Logistic||odds ratio \>1.0 favours Osimertinib 80 mg|||8.84|2.64|<0.001
70927632|NCT02151981|141350387|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-21.62|||<|0.001|TWO_SIDED|95.0|-27.71|-15.52|||ANCOVA|Covariates for ethnicity (Asian, non-Asian) and the baseline sum of diameters of target lesions|LS Mean: Osimertinib -46.93, Chemo -25.3 A difference in LS means \<0 favours Osimertinib 80mg|||-15.52|-27.71|<0.001
70927633|NCT02151981|141350388|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.277|TWO_SIDED|95.0|0.67|1.13|||Log Rank||A hazard ratio \<1 favours Osimertinib 80 mg|||1.13|0.67|0.277
70927634|NCT02151981|141350389|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.21|||<|0.001|TWO_SIDED|95.0|0.16|0.28|||Log Rank||A hazard ratio \<1 favors Osimertinib 80mg|||0.28|0.16|<0.001
70927635|NCT02151981|141350390|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87|||<|0.001|TWO_SIDED|95.0|0.69|1.11|||Log Rank||A hazard ratio \<1 favours Osimertinib 80 mg|||1.11|0.69|<0.001
71010052|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|2.26|STANDARD_ERROR_OF_MEAN|2.26|||TWO_SIDED|95.0|-2.42|6.94|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||6.94|-2.42|
71103485|NCT00863304|141714821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.63|-0.67||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.67|-1.63|<0.001
70927636|NCT04409353|141350486|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 30, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.47||||0.4884|TWO_SIDED|95.0|-0.87|1.81||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The primary analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 7, 15, 21, and 30, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.||1.81|-0.87|0.4884
70927637|NCT04409353|141350486|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 30, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.16||||0.8095|TWO_SIDED|95.0|-1.12|1.43||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The primary analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 7, 15, 21, and 30, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.||1.43|-1.12|0.8095
70927638|NCT04409353|141350487|OTHER|The inference will be based on the treatment comparison of least squares means for Day 60, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.79||||0.3101|TWO_SIDED|95.0|-0.74|2.32||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 60 and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.||2.32|-0.74|0.3101
70927639|NCT04409353|141350487|OTHER|The inference will be based on the treatment comparison of least squares means for Day 60, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.42||||0.6328|TWO_SIDED|95.0|-2.13|1.3||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 60 and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.||1.30|-2.13|0.6328
70927640|NCT04409353|141350487|OTHER|The inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|1.16||||0.126|TWO_SIDED|95.0|-0.33|2.64||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 60 and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.||2.64|-0.33|0.1260
70927641|NCT04409353|141350487|OTHER|The inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.51||||0.515|TWO_SIDED|95.0|-2.05|1.03||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 60 and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.||1.03|-2.05|0.5150
70941332|NCT00985621|141383146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.24||0.526|TWO_SIDED|95.0|-0.63|0.32|||ANCOVA|||Change at Week 2: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.32|-0.63|0.526
70941333|NCT00985621|141383146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.26||0.004|TWO_SIDED|95.0|-1.26|-0.24|||ANCOVA|||Change at Week 4: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.24|-1.26|0.004
71103486|NCT00863304|141714821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.25||0.003|TWO_SIDED|95.0|-1.21|-0.24||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.24|-1.21|0.003
70927642|NCT04409353|141350488|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|1.43||||0.018|TWO_SIDED|95.0|0.25|2.61||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PCS SF-6 score obtained at Days 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PCS SF-6 t-score as a continuous covariate.||2.61|0.25|.0180
70927643|NCT04409353|141350488|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.33||||0.5742|TWO_SIDED|95.0|-1.48|0.82||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PCS SF-6 score obtained at Days 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PCS SF-6 t-score as a continuous covariate.||0.82|-1.48|0.5742
70927644|NCT04409353|141350489|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.39||||0.7338|TWO_SIDED|95.0|-1.85|2.62||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS- Anxiety score obtained at Day 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Anxiety t-score as a continuous covariate.||2.62|-1.85|0.7338
70927645|NCT04409353|141350489|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.63||||0.5279|TWO_SIDED|95.0|-1.34|2.6||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-Anxiety score obtained at Days 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Anxiety t-score as a continuous covariate.||2.60|-1.34|0.5279
70927646|NCT04409353|141350490|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|1.19||||0.1833|TWO_SIDED|95.0|-0.56|2.94||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-Sleep Disturbance score obtained at Days 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Sleep Disturbance t-score as a continuous covariate.||2.94|-0.56|0.1833
70927647|NCT04409353|141350490|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.33||||0.7006|TWO_SIDED|95.0|-2.04|1.37||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-Sleep Disturbance score obtained at Days 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Sleep Disturbance t-score as a continuous covariate.||1.37|-2.04|0.7006
71046270|NCT00754494|141600692|SUPERIORITY_OR_OTHER|||||||0.261|TWO_SIDED||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.261
71046271|NCT00754494|141600693|SUPERIORITY_OR_OTHER|||||||0.654|TWO_SIDED||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.654
71103487|NCT00863304|141714821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.25||0.016|TWO_SIDED|95.0|-1.08|-0.11||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.11|-1.08|0.016
70927648|NCT04409353|141350491|OTHER||Common Odds Ratio|0.76||||0.1913|TWO_SIDED|95.0|0.5|1.15||A two-sided test performed at the 0.05 level of significance without the continuity correction.|Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel (CMH) test was used to compare the association between time (baseline and day 90) and response (yes or no) while stratifying for the treatment groups. The null hypothesis is that the common odds ratio of the association between time and response across the treatment groups is equal to 1, versus the alternative hypothesis that the common odds ratio is not equal to 1.||1.15|0.50|0.1913
70927649|NCT04409353|141350491|OTHER||Common Odds Ratio|0.83||||0.367|TWO_SIDED|95.0|0.55|1.24||A two-sided test performed at the 0.05 level of significance without the continuity correction.|Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel (CMH) test was used to compare the association between time (baseline and day 90) and response (yes or no) while stratifying for the treatment groups. The null hypothesis is that the common odds ratio of the association between time and response across the treatment groups is equal to 1, versus the alternative hypothesis that the common odds ratio is not equal to 1.||1.24|0.55|0.3670
70927650|NCT04409353|141350492|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.83||||0.1619|TWO_SIDED|95.0|-1.98|0.33||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS- PF score obtained for Day 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PF t-score as a continuous covariate.||0.33|-1.98|0.1619
70927651|NCT04409353|141350492|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.04||||0.9569|TWO_SIDED|95.0|-1.31|1.24||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS- PF score obtained for Day 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PF t-score as a continuous covariate.||1.24|-1.31|0.9569
70927652|NCT04409353|141350493|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.03||||0.9727|TWO_SIDED|95.0|-1.8|1.86||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-Depression score obtained for Day 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Depression t-score as a continuous covariate.||1.86|-1.80|0.9727
70927653|NCT04409353|141350493|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.43||||0.6427|TWO_SIDED|95.0|-1.4|2.26||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-Depression score obtained for Day 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Depression t-score as a continuous covariate.||2.26|-1.40|0.6427
70941334|NCT00985621|141383146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.26||0.134|TWO_SIDED|95.0|-0.9|0.12|||ANCOVA|||Change at Week 4: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.12|-0.90|0.134
70941335|NCT00985621|141383146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.27||0.497|TWO_SIDED|95.0|-0.71|0.35|||ANCOVA|||Change at Week 4: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.35|-0.71|0.497
71103488|NCT00863304|141714821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.25||0.082|TWO_SIDED|95.0|-0.91|0.06||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.06|-0.91|0.082
71103489|NCT00863304|141714822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.22||0.001|TWO_SIDED|95.0|-1.12|-0.27||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.27|-1.12|0.001
71103490|NCT00863304|141714822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.22||0.003|TWO_SIDED|95.0|-1.09|-0.23||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.23|-1.09|0.003
70927654|NCT04409353|141350494|OTHER|The inference will be based on the treatment comparison of least squares means for week 12, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the change in the average weekly steps between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|691.58||||0.291|TWO_SIDED|95.0|-602.98|1986.14||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline average weekly steps obtained at weeks 1 thorough 12, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline average weekly steps as a continuous covariate.||1986.14|-602.98|0.2910
70927655|NCT04409353|141350494|OTHER|The inference will be based on the treatment comparison of least squares means for week 12, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the change in the average weekly steps between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|405.68||||0.4842|TWO_SIDED|95.0|-741.79|1553.15||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline average weekly steps obtained at weeks 1 thorough 12, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline average weekly steps as a continuous covariate.||1553.15|-741.79|0.4842
70927656|NCT04409353|141350495|OTHER|The inference will be based on the treatment comparison of least squares means for week 12, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the change in the average weekly sleep scores between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|1.0||||0.4228|TWO_SIDED|95.0|-1.48|3.49||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline average weekly sleep scores obtained at weeks 1 thorough 12, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline sleep score as a continuous covariate.||3.49|-1.48|0.4228
70927657|NCT04409353|141350495|OTHER|The inference will be based on the treatment comparison of least squares means for week 12, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the change in the average weekly sleep scores between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.28||||0.8363|TWO_SIDED|95.0|-2.92|2.37||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline average weekly sleep scores obtained at weeks 1 thorough 12, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline sleep score as a continuous covariate.||2.37|-2.92|0.8363
70927658|NCT04409353|141350496|OTHER||Odds Ratio (OR)|0.83||||0.514|TWO_SIDED|95.0|0.48|1.44||A two-sided test performed at the 0.05 level of significance.|Regression, Logistic||Sham VR as the reference group.|"Responder status (Yes vs. No) will be analyzed as the dependent variable using logistic regression, with terms for treatment groups and baseline PROMIS-PI as predictors. The null hypothesis is that there is no difference between the treatment groups, versus the alternative hypothesis that there a difference exists between the treatment groups."||1.44|0.48|0.514
70927659|NCT04409353|141350496|OTHER||Odds Ratio (OR)|1.35||||0.28|TWO_SIDED|95.0|0.78|2.36||A two-sided test performed at the 0.05 level of significance.|Regression, Logistic||Sham VR as the reference group.|"Responder status (Yes vs. No) will be analyzed as the dependent variable using logistic regression, with terms for treatment groups and baseline PROMIS-PI as predictors. The null hypothesis is that there is no difference between the treatment groups, versus the alternative hypothesis that there a difference exists between the treatment groups."||2.36|0.78|0.280
70927660|NCT05309291|141350499|NON_INFERIORITY|The null hypothesis to demonstrate non-inferiority using a 10% margin for λ FLC RR can be expressed as: Ho: μT-μR ≤ -3.783. The alternative hypothesis is expressed as: Ha: μT-μR \> -3.783 where μT denotes the Theranova 400 treatment mean and μR denotes the FX 800 treatment mean.|Mean Difference (Final Values)|16.99|STANDARD_DEVIATION|8.86|<|0.0001|TWO_SIDED|95.0|14.84|19.15|||t-test, 2 sided|T-test was utilized to generate a two-sided 95% confidence interval (CI) for the difference in means.||Non-inferiority of the Theranova 400 Dialyzer compared to the FX 800 Dialyzer in regard to the λ FLC RR at the mid-week treatment day dialysis session was assessed.||19.15|14.84|<0.0001
70927661|NCT05309291|141350500|NON_INFERIORITY|The null hypothesis to demonstrate non-inferiority using a 10% margin for ß2-MG RR can be expressed as Ho: μT-μR ≤ -7.848. The alternative hypothesis is expressed as: Ha: μT-μR \> -7.848, where μT denotes the Theranova 400 treatment mean and μR denotes the FX 800 treatment mean.|Mean Difference (Final Values)|-1.19|STANDARD_DEVIATION|5.55|<|0.0001|TWO_SIDED|95.0|-2.54|0.16|||t-test, 2 sided|T-test was utilized to generate a two-sided 95% confidence interval (CI) for the difference in means.||Non-inferiority of the Theranova 400 Dialyzer compared to the FX 800 Dialyzer in regard to the β2-MG RR at the mid-week treatment day dialysis session was assessed.||0.16|-2.54|<0.0001
70927662|NCT05292872|141350533|SUPERIORITY||Hazard Ratio (HR)|0.37|||<|0.001|TWO_SIDED|95.0|0.143|0.752||1-sided p-values are proportion of bootstrap replicates exceeding null (defined as a HR of 1) in each direction), and the two-tailed p-value is twice the smaller of one-tailed p-values. A two-tailed p-value was calculated for HR using this method.|Nonparametric bootstrap approach|||||0.752|0.143|<.001
70927663|NCT05260112|141350537|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70927664|NCT05260112|141350538|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70927665|NCT05260112|141350539|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70927666|NCT05260112|141350540|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70927667|NCT05260112|141350541|OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
70927668|NCT05260112|141350542|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70927669|NCT03798093|141350585|SUPERIORITY||least squares|-0.112||||0.08|TWO_SIDED|95.0|-29.3|1.7|||Regression, Linear|||||1.7|-29.3|0.08
70927670|NCT01574274|141350716|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
70927671|NCT01574274|141350717|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||Day 4 NSAA Level||||0.07
70927672|NCT01574274|141350717|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||Day 11 NSAA Level||||0.29
70927673|NCT01574274|141350717|SUPERIORITY|||||||0.0002|||||||t-test, 2 sided|||Day 18 NSAA Level||||0.0002
70927674|NCT01574274|141350717|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Day 25 NSAA Level||||<0.0001
71103491|NCT00863304|141714822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|-1.25|-0.39||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.39|-1.25|<0.001
70927675|NCT01574274|141350717|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Week 7 NSAA Level||||<0.0001
70927676|NCT01574274|141350717|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||Week 13 NSAA Level||||0.87
70927677|NCT01574274|141350717|SUPERIORITY|||||||0.83|||||||t-test, 2 sided|||Week 19 NSAA Level||||0.83
70927678|NCT01574274|141350717|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||Week 25 NSAA Level||||0.94
70927679|NCT05089019|141350725|EQUIVALENCE|Equivalence margin 80% to 125%|Ratio of Geometric LS Mean|0.889|||||TWO_SIDED|94.12|0.81|0.976|||Mixed Models Analysis|Ratio of Geometric Least Square (LS) Mean||||0.976|0.810|
70927680|NCT05089019|141350726|EQUIVALENCE|Equivalence margin 80% to 125%.|Ratio of Geometric LS Mean|0.927|||||TWO_SIDED|94.12|0.882|0.975|||Mixed Models Analysis|||||0.975|0.882|
70927681|NCT05089019|141350727|EQUIVALENCE|Equivalence margin 80% to 125%|Ratio of Geometric LS Mean|0.891|||||TWO_SIDED|94.12|0.834|0.951|||Mixed Models Analysis|||||0.951|0.834|
70927682|NCT03216057|141350738|SUPERIORITY|The sample size was calculated that 130 subjects randomized in a 1:1 fashion between the 2 arms have 85% power to detect a difference of at least 20% in triglyceride percentage changes compared with placebo at week 12, assuming a common standard deviation in percentage change of 35%, a 2-sided α = 0.05, and we add 20% for lost follow-up, finally the number of subjects for each arm was 65.|Mean Difference (Net)|-24.5|||<|0.01|TWO_SIDED|95.0|-32.7|-16.2|||t-test, 2 sided|||||-16.2|-32.7|<0.01
70927683|NCT03216057|141350739|SUPERIORITY||Mean Difference (Net)|-59.9|||<|0.01|TWO_SIDED|95.0|-83.0|-36.8|||t-test, 2 sided|||||-36.8|-83.0|<0.01
70927684|NCT03216057|141350740|SUPERIORITY||Mean Difference (Net)|-9.0||||0.01|TWO_SIDED|95.0|-16.1|-1.9|||t-test, 2 sided|||||-1.9|-16.1|0.01
70927685|NCT03216057|141350741|SUPERIORITY||Mean Difference (Net)|-4.9||||0.3|TWO_SIDED|95.0|-15.8|6.05|||t-test, 2 sided|||||6.05|-15.8|0.3
70927686|NCT03216057|141350742|SUPERIORITY||Mean Difference (Net)|-12.4|||<|0.01|TWO_SIDED|95.0|-21.2|-3.5|||t-test, 2 sided|||||-3.5|-21.2|<0.01
70927687|NCT03216057|141350743|SUPERIORITY||Mean Difference (Net)|-2.2||||0.02|TWO_SIDED|95.0|-4.1|-0.3|||t-test, 2 sided|||||-0.3|-4.1|0.02
70927688|NCT03216057|141350744|SUPERIORITY||Mean Difference (Net)|-1.2||||0.6|TWO_SIDED|95.0|-6.3|3.8|||t-test, 2 sided|||||3.8|-6.3|0.6
70927689|NCT03216057|141350745|SUPERIORITY||Mean Difference (Net)|1.9||||0.1|TWO_SIDED|95.0|-0.9|4.9|||t-test, 2 sided|||||4.9|-0.9|0.1
70927690|NCT03216057|141350746|SUPERIORITY||Mean Difference (Net)|13.4|||<|0.01|TWO_SIDED|95.0|5.8|21.0|||t-test, 2 sided|||||21|5.8|<0.01
70927691|NCT03216057|141350747|SUPERIORITY||Mean Difference (Net)|0.8|||<|0.01|TWO_SIDED|95.0|0.4|1.2|||t-test, 2 sided|||||1.2|0.4|<0.01
70927692|NCT04564742|141350748|SUPERIORITY||Win Ratio (WR)|1.34|||<|0.001|TWO_SIDED|95.0|1.2|1.5||A closed testing procedure including a pre-specified hierarchical ordering of the primary and secondary endpoints was utilised. No multiplicity control was placed on the exploratory endpoints.|Win Ratio Analysis|||The primary objective of the study was to determine if the clinical benefit of dapagliflozin was superior as compared with placebo, utilizing a hierarchical composite endpoint and win-ratio (WR) method. With a presumed WR of 1.20, 4000 patients were provide an 80% statistical power for the primary endpoint, maintaining a 1:1 allocation between treatments. The primary analysis was based on the intention-to-treat principle using the Full Analysis Set.||1.50|1.20|<0.001
70927693|NCT05270408|141350767|SUPERIORITY||Cohen's d|0.93||||0.25|TWO_SIDED||||||ANCOVA|||RAVLT Total Learning||||0.25
70927694|NCT05270408|141350767|SUPERIORITY||Cohen's d|0.69||||0.18|TWO_SIDED||||||ANCOVA|||RAVLT Total Learning||||0.18
70927695|NCT05270408|141350767|SUPERIORITY||Cohen's d|0.74||||0.48|TWO_SIDED||||||ANCOVA|||RAVLT Delayed||||0.48
70927696|NCT05270408|141350767|SUPERIORITY||Cohen's d|0.19||||0.64|TWO_SIDED||||||ANCOVA|||RAVLT Delayed||||0.64
70927697|NCT05270408|141350768|SUPERIORITY||Cohen's d|0.03||||0.98|TWO_SIDED||||||ANCOVA|||BVMT total learning||||0.98
70927698|NCT05270408|141350768|SUPERIORITY||Cohen's d|0.86||||0.22|TWO_SIDED||||||ANCOVA|||BVMT total learning||||0.22
70927699|NCT05270408|141350768|SUPERIORITY||Cohen's d|0.04||||0.97|TWO_SIDED||||||ANCOVA|||BVMT delayed||||0.97
70927700|NCT05270408|141350768|SUPERIORITY||Cohen's d|0.69||||0.23|TWO_SIDED||||||ANCOVA|||BVMT delayed||||0.23
70927701|NCT05270408|141350769|SUPERIORITY||Cohen's d|0.04||||0.94|TWO_SIDED||||||ANCOVA|||||||0.94
70927702|NCT05270408|141350769|SUPERIORITY||Cohen's d|0.42||||0.47|TWO_SIDED||||||ANCOVA|||||||0.47
70927703|NCT05270408|141350770|SUPERIORITY||Cohen's d|1.49||||0.06|TWO_SIDED||||||ANCOVA|||||||0.06
70927704|NCT05270408|141350770|SUPERIORITY||Cohen's d|1.08||||0.07|TWO_SIDED||||||ANCOVA|||||||0.07
70927705|NCT05270408|141350771|SUPERIORITY||Cohen's d|0.19||||0.61|TWO_SIDED||||||ANCOVA|||||||0.61
70927706|NCT05270408|141350771|SUPERIORITY||Cohen's d|0.68||||0.38|TWO_SIDED||||||ANCOVA|||||||0.38
70927707|NCT05270408|141350773|SUPERIORITY||Cohen's d|0.96||||0.11|TWO_SIDED||||||ANCOVA|||||||0.11
71103492|NCT00863304|141714822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.22||0.572|TWO_SIDED|95.0|-0.31|0.55||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.55|-0.31|0.572
70850353|NCT00947882|141188491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.44||||0.0865|TWO_SIDED|||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 3. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 20 mg and Placebo at Month 3."|Analysis of Covariance (ANCOVA) of the change from baseline in IPSS at Month 3 in the FAS population using the Last Observation Carried Forward (LOCF) method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.0865
70927708|NCT05270408|141350773|SUPERIORITY|||||||0.68|||||||ANCOVA||||Eta2 effect sizes produced from the pairwise comparisons were transformed to Cohen's d for examination of effect sizes. A small/weak effect size was demonstrated (Cohen's d = 0.10), when adjusting for baseline performance.|||0.68
71046272|NCT00754494|141600693|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.030
71046273|NCT00754494|141600693|SUPERIORITY_OR_OTHER|||||||0.083|TWO_SIDED||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.083
71046274|NCT02990806|141600702|EQUIVALENCE|A test for equivalence was carried out using an asymmetric margin (-12%, 15%) pre-specified in protocol and a two 1-sided test (TOST) analysis with α=0.05 for each 1-sided statistical test.|Percentage difference|3.6|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-4.3|11.5||||||||11.5|-4.3|
71046275|NCT00700817|141600740|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.|Estimated treatment difference, LS Mean|-0.6||||0.0001||95.0|-0.77|-0.43||Multiple comparisons not applicable due to the hieracheal testing.|ANCOVA|Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).||ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate. Hieracheal testing of non-inferiority followed by superiority.||-0.43|-0.77|0.0001
71046276|NCT00700817|141600740|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.|Estimated treatment difference, LS Mean|-0.34||||0.0001||95.0|-0.51|-0.16||Multiple comparisons not applicable due to the hieracheal testing.|ANCOVA|Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).||ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate. Hieracheal testing of non-inferiority followed by superiority. Liraglutide 1.2 mg versus sitagliptin only tested if liraglutide 1.8 mg was superior to sitagliptin.||-0.16|-0.51|0.0001
71046277|NCT00700817|141600741|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.|Estimated Treatment Difference, LS Mean|-0.63||||0.0001||95.0|-0.81|-0.44||Multiple comparisons not applicable due to the hieracheal testing.|ANCOVA|Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).|Lira 1.8 - Sita|ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate.||-0.44|-0.81|0.0001
71046278|NCT00700817|141600741|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.|Estimated Treatment Difference, LS Mean|-0.4||||0.0001||95.0|-0.59|-0.22||Multiple comparisons not applicable due to the hieracheal testing.|ANCOVA|Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).|Lira 1.2 - Sita|ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate.||-0.22|-0.59|0.0001
71046279|NCT00700817|141600743|SUPERIORITY_OR_OTHER||Change within treatment group|-0.24|STANDARD_DEVIATION|0.7||0.006||95.0|-0.41|-0.07||Multiple comparisons is not applicable.|paired t-test|The analysis is not a controlled comparison, and there are no adjustments||The t-test was performed to examine whether the change in HbA1c from week 52 to week 78 were different from 0 within each treatment group.||-0.07|-0.41|0.0060
71046280|NCT00700817|141600743|SUPERIORITY_OR_OTHER||Change within treatment group|-0.45|STANDARD_DEVIATION|0.9||0.0001||95.0|-0.67|-0.23||Multiple comparisons is not applicable.|paired t-test|The analysis is not a controlled comparison, and there are no adjustments||The t-test was performed to examine whether the change in HbA1c from week 52 to week 78 were different from 0 within each treatment group.||-0.23|-0.67|0.0001
71046281|NCT01338987|141600816|OTHER|||||||0.0075|||||||Wilcoxon's rank sum test|||||||0.0075
71046282|NCT00606502|141600823|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.84|||||TWO_SIDED|95.0|0.61|1.14||||||||1.14|0.61|
71046283|NCT02480582|141600836|SUPERIORITY_OR_OTHER||||||<|0.01||||||Where significant effects were obtained post hoc analyses, with a Bonferroni correction for multiple comparisons were conducted.|ANOVA|Null hypothesis is that there was no difference in energy intake between almonds, cheese savouries and no food.||||||<0.01
71046284|NCT02480582|141600837|SUPERIORITY_OR_OTHER||||||<|0.05||||||Where significant effects were obtained post hoc analyses, with a Bonferroni correction for multiple comparisons were conducted.|ANOVA|Null hypothesis is that there was no difference in wanting for high fat foods between almonds, cheese savouries and no food.||||||<0.05
71046285|NCT02480582|141600838|SUPERIORITY_OR_OTHER||||||<|0.001||||||Where significant effects were obtained post hoc analyses, with a Bonferroni correction for multiple comparisons were conducted.|ANOVA|Null hypothesis is that there was no difference in hunger AUC between almonds, cheese savouries and no food.||||||<0.001
70927709|NCT06044090|141350776|SUPERIORITY|||||||0.856|||||||t-test, 2 sided|||||||0.856
70927710|NCT06044090|141350776|SUPERIORITY|||||||0.613|||||||t-test, 2 sided|||||||0.613
70927711|NCT06044090|141350777|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
70927712|NCT06044090|141350777|SUPERIORITY|||||||0.691|||||||t-test, 2 sided|||||||0.691
70927713|NCT06044090|141350778|SUPERIORITY|||||||0.225|||||||t-test, 2 sided|||||||0.225
70927714|NCT06044090|141350778|SUPERIORITY|||||||0.667|||||||t-test, 2 sided|||||||0.667
70927715|NCT02465268|141350785|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.196|TWO_SIDED|95.0|0.77|2.16|||Log Rank|||||2.16|0.77|0.196
70927716|NCT02465268|141350785|SUPERIORITY||Hazard Ratio (HR)|1.63||||0.196|TWO_SIDED|95.0|0.99|2.7|||Log Rank|||||2.70|0.99|0.196
70927717|NCT02465268|141350786|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.354|TWO_SIDED|95.0|0.6|1.61|||Log Rank|||||1.61|0.60|0.354
70927718|NCT02465268|141350786|SUPERIORITY||Hazard Ratio (HR)|1.42||||0.354|TWO_SIDED|95.0|0.87|2.33|||Log Rank|||||2.33|0.87|0.354
71010053|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|6.9|STANDARD_ERROR_OF_MEAN|2.41|||TWO_SIDED|95.0|1.91|11.89|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||11.89|1.91|
71010054|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|6.15|STANDARD_ERROR_OF_MEAN|2.38|||TWO_SIDED|95.0|1.22|11.08|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||11.08|1.22|
70927719|NCT02465268|141350787|SUPERIORITY|||||||0.038|||||||Kruskal-Wallis|||||||0.038
70927720|NCT02465268|141350787|SUPERIORITY|||||||0.038|||||||Kruskal-Wallis|||||||0.038
70927721|NCT02465268|141350787|SUPERIORITY|||||||0.038|||||||Kruskal-Wallis|||||||0.038
70927722|NCT02465268|141350789|SUPERIORITY|||||||0.2|||||||Kruskal-Wallis|||||||0.2
70927723|NCT02465268|141350789|SUPERIORITY|||||||0.2|||||||Kruskal-Wallis|||||||0.2
70927724|NCT02465268|141350789|SUPERIORITY|||||||0.2|||||||Kruskal-Wallis|||||||0.2
70927725|NCT02465268|141350790|SUPERIORITY|||||||0.6|||||||Kruskal-Wallis|||||||0.6
70927726|NCT02465268|141350790|SUPERIORITY|||||||0.6|||||||Kruskal-Wallis|||||||0.6
70927727|NCT02465268|141350790|OTHER|||||||0.6|||||||Kruskal-Wallis|||||||0.6
70927728|NCT02465268|141350792|SUPERIORITY|||||||0.13|||||||Kruskal-Wallis|||||||0.13
70927729|NCT02465268|141350792|SUPERIORITY|||||||0.13|||||||Kruskal-Wallis|||||||0.13
70927730|NCT02465268|141350792|SUPERIORITY|||||||0.13|||||||Kruskal-Wallis|||||||0.13
70927731|NCT03532282|141350793|SUPERIORITY||coefficient beta for change trajectory|-0.15||||0.001|TWO_SIDED|||||The a-priori threshold for statistical significance was 0.05|Mixed Models Analysis|Mixed effects model incorporating all assessment time points.||||||0.001
70927732|NCT03532282|141350794|SUPERIORITY||coefficient beta for change trajectory|-0.01||||0.01|TWO_SIDED|||||The a-priori threshold for statistical significance was 0.05|Mixed Models Analysis|Mixed effects model incorporating all assessment time points.||||||0.01
70927733|NCT03532282|141350795|SUPERIORITY||coefficient beta for change trajectory|-0.24||||0.0006|TWO_SIDED|||||The a-priori threshold for statistical significance was 0.05|Mixed Models Analysis|Mixed effects model incorporating all assessment time points.||||||0.0006
70927734|NCT03532282|141350796|SUPERIORITY||coefficient beta for change trajectory|-0.04||||0.05|TWO_SIDED|||||The a-priori threshold for statistical significance was 0.05|Mixed Models Analysis|Mixed effects model incorporating all assessment time points.||||||0.05
70927735|NCT05651308|141350849|SUPERIORITY||Risk Difference (RD)|0.026||||0.37|TWO_SIDED|95.0|-0.03|0.08|||Chi-squared||Risk difference = Intervention proportion minus control proportion.|||0.08|-0.03|0.37
70927736|NCT05825755|141350871|SUPERIORITY|||||||0.252|||||||Wilcoxon (Mann-Whitney)|||||||0.252
70927737|NCT05825755|141350872|SUPERIORITY|||||||1|||||||McNemar|||||||1.0
70927738|NCT05825755|141350873|SUPERIORITY|||||||0.791|||||||Wilcoxon (Mann-Whitney)|||||||0.791
70927739|NCT02675777|141350915|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
70927740|NCT02675777|141350916|SUPERIORITY|||||||0.3|||||||Mixed Models Analysis|||||||0.30
70927741|NCT05228457|141350922|SUPERIORITY|13 participants were randomized to receive active TMS, and 13 were randomized to receive sham TMS. 1 participant from each group withdrew, resulting in their exclusion from the analysis. Therefore, 24 participants were randomized to active (n = 12) or sham (n = 12) aiTBS groups. The analysis examined MADRS scores measured at baseline and post-treatment. A priori hypotheses were that active aiTBS would demonstrate measurable differences in MADRS scores compared to the sham group.|Mean Difference (Final Values)|-14.8|||<|0.001|TWO_SIDED|95.0|-19.94|-9.56|||t-test, 2 sided||The primary outcome was the between-group (Active vs Sham) difference in MADRS scores at the end of the treatment period. Results, including mean scores, standard deviations, confidence intervals, and p-value for the between-group comparisons.|||-9.56|-19.94|<0.001
70927742|NCT05228457|141350923|SUPERIORITY||Z-transformed Pearson's r values|-0.014||||0.04|TWO_SIDED||||||t-test, 2 sided|||Z-transformed Pearson's r values of average voxel-wise connectivity within the DMN||||0.04
70927743|NCT00691002|141350933|SUPERIORITY||Odds Ratio (OR)|1.28||||0.11|TWO_SIDED|95.0|0.94|1.74|||Cochran-Mantel-Haenszel|||Test for superiority of LEO 80190 ointment versus calcipotriol ointment at Week 8 LOCF (Last Observation Carried Forward).||1.74|0.94|0.11
70927744|NCT00691002|141350933|SUPERIORITY||Odds Ratio (OR)|1.79|||<|0.001|TWO_SIDED|95.0|1.31|2.45|||Cochran-Mantel-Haenszel|||Test for superiority of LEO 80190 ointment versus hydrocortisone ointment at Week 8 LOCF (Last Observation Carried Forward).||2.45|1.31|<0.001
70927745|NCT00691002|141350933|SUPERIORITY||Odds Ratio (OR)|2.7|||<|0.001|TWO_SIDED|95.0|1.8|4.04|||Cochran-Mantel-Haenszel|||Test for superiority of LEO 80190 ointment versus ointment vehicle at Week 8 LOCF (Last Observation Carried Forward).||4.04|1.80|<0.001
70927746|NCT01152450|141350948|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.149|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.102|0.196|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.196|0.102|<0.0001
71010055|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|4.99|STANDARD_ERROR_OF_MEAN|2.38|||TWO_SIDED|95.0|0.05|9.93|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||9.93|0.05|
70927747|NCT01152450|141350948|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.111|0.205|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.205|0.111|<0.0001
70927748|NCT01152450|141350948|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.009|STANDARD_ERROR_OF_MEAN|0.024||||95.0|-0.038|0.056|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.056|-0.038|
70927749|NCT01152450|141350949|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.328|STANDARD_ERROR_OF_MEAN|5.19|<|0.0001||95.0|11.084|31.573|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||31.573|11.084|<0.0001
70927750|NCT01152450|141350949|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|22.357|STANDARD_ERROR_OF_MEAN|5.225|<|0.0001||95.0|12.044|32.67|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||32.670|12.044|<0.0001
70927751|NCT01152450|141350949|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.029|STANDARD_ERROR_OF_MEAN|5.242||||95.0|-9.318|11.376|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||11.376|-9.318|
70927752|NCT01152450|141350950|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29.92|STANDARD_ERROR_OF_MEAN|5.026|<|0.0001||95.0|20.001|39.839|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||39.839|20.001|<0.0001
70927753|NCT01152450|141350950|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|28.657|STANDARD_ERROR_OF_MEAN|5.042|<|0.0001||95.0|18.707|38.606|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||38.606|18.707|<0.0001
70927754|NCT01152450|141350950|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.264|STANDARD_ERROR_OF_MEAN|5.056||||95.0|-11.243|8.716|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||8.716|-11.243|
70927755|NCT01152450|141350951|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001||95.0|0.12|0.218|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.218|0.120|<0.0001
70927756|NCT01152450|141350951|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001||95.0|0.136|0.234|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.234|0.136|<0.0001
70927757|NCT01152450|141350951|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.025||||95.0|-0.033|0.065|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.065|-0.033|
70927758|NCT01152450|141350952|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.077|0.181|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.181|0.077|<0.0001
70927759|NCT01152450|141350952|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.079|0.183|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.183|0.079|<0.0001
71046286|NCT02480582|141600839|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|Null hypothesis is that there was no difference in energy intake between almonds, cheese savouries and no food.||"Energy intake measured by ad-libitum test meals (breakfast, lunch, dinner) during each intervention condition.~Null hypothesis is that there was no difference in total energy intake between almonds, cheese savouries and no food."||||<0.05
70927760|NCT01152450|141350952|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.026||||95.0|-0.05|0.054|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.054|-0.050|
70927761|NCT01152450|141350953|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.084|0.179|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.179|0.084|<0.0001
70927762|NCT01152450|141350953|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.084|0.179|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.179|0.084|<0.0001
70927763|NCT01152450|141350953|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.024||||95.0|-0.048|0.047|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.047|-0.048|
71046287|NCT01770431|141600889|SUPERIORITY||chi-squared|14.7315||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0001
71046288|NCT01770431|141600890|SUPERIORITY||Hazard Ratio (HR)|0.67|||<|0.0001|TWO_SIDED|95.0|0.55|0.81|||Regression, Cox|||||0.81|0.55|<0.0001
70927764|NCT01152450|141350954|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.03||0.0002||95.0|0.053|0.17|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.170|0.053|0.0002
70927765|NCT01152450|141350954|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.074|0.191|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.191|0.074|<0.0001
70927766|NCT01152450|141350954|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.03||||95.0|-0.037|0.08|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.080|-0.037|
70927767|NCT01152450|141350955|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.035||0.0515||95.0|0.0|0.136|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.136|0.000|0.0515
70927768|NCT01152450|141350955|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.035||0.1058||95.0|-0.012|0.124|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.124|-0.012|0.1058
70927769|NCT01152450|141350955|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.012|STANDARD_ERROR_OF_MEAN|0.035||||95.0|-0.08|0.057|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.057|-0.080|
71046289|NCT03407118|141600891|SUPERIORITY||ratio of least square means|0.967|||||TWO_SIDED|95.0|0.803|1.17||||||||1.17|0.803|
70927770|NCT01152450|141350956|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.073|0.177|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.177|0.073|<0.0001
70927771|NCT01152450|141350956|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.026||0.0002||95.0|0.048|0.152|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.152|0.048|0.0002
70927772|NCT01152450|141350956|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.025|STANDARD_ERROR_OF_MEAN|0.026||||95.0|-0.077|0.027|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.027|-0.077|
70927773|NCT01152450|141350957|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.076|STANDARD_ERROR_OF_MEAN|0.027||0.0051||95.0|0.023|0.129|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.129|0.023|0.0051
70927774|NCT01152450|141350957|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.027||0.0123||95.0|0.015|0.12|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.120|0.015|0.0123
70927775|NCT01152450|141350957|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.027||||95.0|-0.061|0.045|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.045|-0.061|
70927776|NCT01152450|141350958|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.027||0.0042||95.0|0.025|0.13|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.130|0.025|0.0042
70927777|NCT01152450|141350958|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.027||0.0747||95.0|-0.005|0.1|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.100|-0.005|0.0747
70927778|NCT01152450|141350958|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.029|STANDARD_ERROR_OF_MEAN|0.027||||95.0|-0.082|0.023|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.023|-0.082|
70927779|NCT01152450|141350962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.055|0.147|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.147|0.055|<0.0001
70927780|NCT01152450|141350962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.023||0.0004||95.0|0.038|0.13|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.130|0.038|0.0004
70927781|NCT01152450|141350962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.016|STANDARD_ERROR_OF_MEAN|0.023||||95.0|-0.063|0.03|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.030|-0.063|
70927782|NCT01152450|141350963|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|30.242|STANDARD_ERROR_OF_MEAN|4.091|<|0.0001||95.0|22.167|38.317|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||38.317|22.167|<0.0001
71046290|NCT00515034|141600925|NON_INFERIORITY_OR_EQUIVALENCE|Percent of participants who are clinically cured including 95% confidence intervals are provided.|Risk Difference (RD)|-13.8|||||TWO_SIDED|95.0|-54.4|26.8|||normal approximation to the binomial||Treatment difference (doripenem minus imipenem/cilastatin) in percent of participants who are clinically cured.|There is no formal hypothesis test for this outcome. Only summary data are provided.||26.8|-54.4|
71046291|NCT00515034|141600926|NON_INFERIORITY_OR_EQUIVALENCE|Percent of participants who are clinically cured including 95% confidence intervals are provided.|Risk Difference (RD)|18.7|||||TWO_SIDED|95.0|-13.2|50.6|||normal approximation to binomial||Treatment difference (doripenem minus imipenem) in percent of participants who are clinically cured.|There is no formal hypothesis test for this outcome. Only summary data are presented.||50.6|-13.2|
71046292|NCT01392326|141600927|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.53|||<|0.0001|TWO_SIDED|95.0|3.46|8.85|||Regression, Logistic|||||8.85|3.46|<0.0001
71046293|NCT01392326|141600927|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.39|||<|0.0001|TWO_SIDED|95.0|3.37|8.62|||Regression, Logistic|||||8.62|3.37|<0.0001
71046294|NCT02508259|141600937|EQUIVALENCE|The null hypothesis was that before and after treatment ADOS scores were equivalent.|Mean Difference (Net)|-1.6|STANDARD_DEVIATION|0.55||0.0028|TWO_SIDED|95.0|-2.3|-0.9|||t-test, 2 sided|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.||-0.9|-2.3|0.0028
70927783|NCT01152450|141350963|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|34.31|STANDARD_ERROR_OF_MEAN|4.089|<|0.0001||95.0|26.24|42.38|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||42.380|26.240|<0.0001
70927784|NCT01152450|141350963|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.068|STANDARD_ERROR_OF_MEAN|4.094||||95.0|-4.012|12.148|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||12.148|-4.012|
70927785|NCT01152450|141350964|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.323|STANDARD_ERROR_OF_MEAN|0.769||0.6747||95.0|-1.195|1.841|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||1.841|-1.195|0.6747
70927786|NCT01152450|141350964|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.389|STANDARD_ERROR_OF_MEAN|0.774||0.6159||95.0|-1.138|1.916|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||1.916|-1.138|0.6159
70927787|NCT01152450|141350964|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.777||||95.0|-1.468|1.599|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||1.599|-1.468|
70927788|NCT01152450|141350965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.077|STANDARD_ERROR_OF_MEAN|0.142||0.5906||95.0|-0.358|0.204|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.204|-0.358|0.5906
70927789|NCT01152450|141350965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.176|STANDARD_ERROR_OF_MEAN|0.143||0.2208||95.0|-0.458|0.106|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.106|-0.458|0.2208
70927790|NCT01152450|141350965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.099|STANDARD_ERROR_OF_MEAN|0.143||||95.0|-0.382|0.184|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.184|-0.382|
70927791|NCT01152450|141350966|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.082||0.9797||95.0|-0.163|0.159|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.159|-0.163|0.9797
70927792|NCT01152450|141350966|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.062|STANDARD_ERROR_OF_MEAN|0.082||0.4518||95.0|-0.223|0.1|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.100|-0.223|0.4518
70927793|NCT01152450|141350966|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.082||||95.0|-0.222|0.102|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.102|-0.222|
70927794|NCT01152450|141350967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.074||0.4089||95.0|-0.207|0.085|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.085|-0.207|0.4089
70927795|NCT01152450|141350967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.074|STANDARD_ERROR_OF_MEAN|0.074||0.3185||95.0|-0.221|0.072|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.072|-0.221|0.3185
70927796|NCT01152450|141350967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.013|STANDARD_ERROR_OF_MEAN|0.074||||95.0|-0.16|0.134|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.134|-0.160|
70927797|NCT01152450|141350968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.031||0.9626||95.0|-0.059|0.062|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.062|-0.059|0.9626
70927798|NCT01152450|141350968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.003|STANDARD_ERROR_OF_MEAN|0.031||0.9102||95.0|-0.058|0.065|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.065|-0.058|0.9102
70927799|NCT01152450|141350968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.031||||95.0|-0.059|0.063|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.063|-0.059|
70927800|NCT05139810|141350969|SUPERIORITY||IC HAE attack rate ratio|0.19|||<|0.001|TWO_SIDED|95.0|0.107|0.351|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 1 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used to account for potential over dispersion.||0.351|0.107|<0.001
71079466|NCT00482170|141666446|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.079|TWO_SIDED|95.0|0.45|1.04||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.04|0.45|0.079
70927801|NCT05139810|141350969|SUPERIORITY||IC HAE attack rate ratio|0.45|||=|0.004|TWO_SIDED|95.0|0.261|0.777|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 1 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential overdispersion.||0.777|0.261|=0.004
70927802|NCT05139810|141350970|SUPERIORITY||IC HAE attack rate ratio|0.13|||<|0.001|TWO_SIDED|95.0|0.062|0.281|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 5 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential over dispersion.||0.281|0.062|<0.001
70927803|NCT05139810|141350970|SUPERIORITY||IC HAE attack rate ratio|0.4|||=|0.004|TWO_SIDED|95.0|0.212|0.748|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 5 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential over dispersion.||0.748|0.212|=0.004
70927804|NCT05139810|141350971|SUPERIORITY||Odds Ratio (OR)|11.79|||=|0.003|TWO_SIDED|95.0|2.34|59.36|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.||||59.36|2.34|=0.003
70927805|NCT05139810|141350971|SUPERIORITY||Odds Ratio (OR)|3.23|||=|0.24|TWO_SIDED|95.0|0.46|22.85|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.||||22.85|0.46|=0.240
70927806|NCT05139810|141350972|SUPERIORITY||IC HAE attack rate ratio|0.11|||<|0.001|TWO_SIDED|95.0|0.035|0.339|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 5 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential over dispersion.||0.339|0.035|<0.001
70927807|NCT05139810|141350972|SUPERIORITY||IC HAE attack rate ratio|0.59|||=|0.173|TWO_SIDED|95.0|0.276|1.26|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 5 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential over dispersion.||1.260|0.276|=0.173
70927808|NCT05139810|141350973|SUPERIORITY||Odds Ratio (OR)|310.35|||<|0.001|TWO_SIDED|95.0|11.63|8279.94|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.|The odds ratio and its 95% confidence interval were calculated based on a logistic regression with baseline (the time-normalized run-in period attack rate) and the treatment-by-baseline interaction as a covariate.|≥ 50% Reduction||8279.94|11.63|<0.001
70927809|NCT05139810|141350973|SUPERIORITY||Odds Ratio (OR)|14.8|||<|0.001|TWO_SIDED|95.0|3.15|69.41|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.|The odds ratio and its 95% confidence interval were calculated based on a logistic regression with baseline (the time-normalized run-in period attack rate) and the treatment-by-baseline interaction as a covariate.|≥ 50% Reduction||69.41|3.15|<0.001
70927810|NCT05139810|141350973|SUPERIORITY||Odds Ratio (OR)|34.74|||<|0.001|TWO_SIDED|95.0|7.32|164.87|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.|The odds ratio and its 95% confidence interval were calculated based on a logistic regression with baseline (the time-normalized run-in period attack rate) and the treatment-by-baseline interaction as a covariate.|≥ 70% Reduction||164.87|7.32|<0.001
70927811|NCT05139810|141350973|SUPERIORITY||Odds Ratio (OR)|9.17|||=|0.004|TWO_SIDED|95.0|2.05|41.09|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.|The odds ratio and its 95% confidence interval were calculated based on a logistic regression with baseline (the time-normalized run-in period attack rate) and the treatment-by-baseline interaction as a covariate.|≥ 70% Reduction||41.09|2.05|=0.004
70927812|NCT05139810|141350973|SUPERIORITY||Odds Ratio (OR)|17.04|||<|0.001|TWO_SIDED|95.0|3.36|86.42|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.|The odds ratio and its 95% confidence interval were calculated based on a logistic regression with baseline (the time-normalized run-in period attack rate) and the treatment-by-baseline interaction as a covariate.|≥ 90% Reduction||86.42|3.36|<0.001
70927813|NCT05139810|141350973|SUPERIORITY||Odds Ratio (OR)|8.7|||=|0.014|TWO_SIDED|95.0|1.56|48.52|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.|The odds ratio and its 95% confidence interval were calculated based on a logistic regression with baseline (the time-normalized run-in period attack rate) and the treatment-by-baseline interaction as a covariate.|≥ 90% Reduction||48.52|1.56|=0.014
70927814|NCT05139810|141350974|SUPERIORITY||IC HAE attack rate ratio|0.08|||<|0.001|TWO_SIDED|95.0|0.03|0.234|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 5 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential over dispersion.||0.234|0.030|<0.001
70927815|NCT05139810|141350974|SUPERIORITY||IC HAE attack rate ratio|0.33|||=|0.004|TWO_SIDED|95.0|0.155|0.706|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 5 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential over dispersion.||0.706|0.155|=0.004
70927816|NCT05139810|141350976|SUPERIORITY||Treatment difference|-18.56|||<|0.001|TWO_SIDED|95.0|-27.673|-9.454|||Mixed model with repeated measures(MMRM)|||||-9.454|-27.673|<0.001
71079467|NCT00482170|141666446|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||0.063|TWO_SIDED|95.0|0.46|1.02||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.02|0.46|0.063
70927817|NCT05139810|141350976|SUPERIORITY||Treatment difference|-13.65|||=|0.01|TWO_SIDED|95.0|-24.024|-3.286|||MMRM|||||-3.286|-24.024|=0.010
70927818|NCT04753697|141350988|SUPERIORITY||Difference in Least Square Mean|-1.91|STANDARD_ERROR_OF_MEAN|0.544||0.0005|TWO_SIDED|95.0|-2.97|-0.84|||ANCOVA|||||-0.84|-2.97|0.0005
70927819|NCT04753697|141350989|SUPERIORITY||Difference in percentage|26.4|||<|0.0001|TWO_SIDED|95.0|20.6|32.2|||Cochran-Mantel-Haenszel|Imputed data is used in CMH test, which is stratified by Steroid Inadequate Responder/Intolerant status.||||32.2|20.6|<0.0001
70927820|NCT04753697|141350990|SUPERIORITY||DIFFERENCE IN RESPONSE RATE AFTER MI(%)|18.4|||<|0.0001|TWO_SIDED|95.0|11.3|25.5|||Cochran-Mantel-Haenszel|Imputed data is used in CMH test, which is stratified by Steroid Inadequate Responder/Intolerant status.||||25.5|11.3|<0.0001
70927821|NCT04753697|141350990|SUPERIORITY||DIFFERENCE IN RESPONSE RATE AFTER MI(%)|17.0|||<|0.0001|TWO_SIDED|95.0|10.1|24.0||Imputed data is used in CMH test, which is stratified by Steroid Inadequate Responder/Intolerant status.|Cochran-Mantel-Haenszel|||||24.0|10.1|<0.0001
70927822|NCT04753697|141350991|SUPERIORITY||DIFFERENCE IN RESPONSE RATE AFTER MI (%)|40.0|||<|0.0001|TWO_SIDED|95.0|33.3|46.7|||Cochran-Mantel-Haenszel|Imputed data is used in CMH test, which is stratified by Steroid Inadequate Responder/Intolerant status||||46.7|33.3|<0.0001
70927823|NCT04753697|141350992|SUPERIORITY||DIFFERENCE IN RESPONSE RATE AFTER MI (%)|25.7|||<|0.0001|TWO_SIDED|95.0|17.8|33.6|||Cochran-Mantel-Haenszel|Imputed data is used for all in CMH test, which is stratified by Steroid Inadequate Responder/Intolerant status.||||33.6|17.8|<0.0001
70927824|NCT04753697|141350992|SUPERIORITY||DIFFERENCE IN RESPONSE RATE AFTER MI (%)|27.7|||<|0.0001|TWO_SIDED|95.0|19.7|35.7|||Cochran-Mantel-Haenszel|Imputed data is used for all in CMH test, which is stratified by Steroid Inadequate Responder/Intolerant status.||||35.7|19.7|<0.0001
70927825|NCT04753697|141350993|SUPERIORITY||DIFFERENCE IN LSM|-2.26|STANDARD_ERROR_OF_MEAN|0.655||0.0006|TWO_SIDED|95.0|-3.55|-0.98|||ANCOVA|||||-0.98|-3.55|0.0006
71103493|NCT00863304|141714822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.22||0.467|TWO_SIDED|95.0|-0.27|0.59||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.59|-0.27|0.467
71103494|NCT00863304|141714822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.73|-0.82||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.82|-1.73|<0.001
71103495|NCT00863304|141714822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.61|-0.7||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.70|-1.61|<0.001
71103496|NCT00863304|141714822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.23||0.003|TWO_SIDED|95.0|-1.16|-0.24||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.24|-1.16|0.003
71103497|NCT00863304|141714822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.23||0.015|TWO_SIDED|95.0|-1.03|-0.11||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.11|-1.03|0.015
71103498|NCT00863304|141714822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.23||0.053|TWO_SIDED|95.0|-0.91|0.01||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.01|-0.91|0.053
71103499|NCT00863304|141714822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.21|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.66|-0.75||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.75|-1.66|<0.001
71103500|NCT00863304|141714822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.11|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.56|-0.65||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.65|-1.56|<0.001
70927826|NCT04753697|141350993|SUPERIORITY||DIFFERENCE IN LSM|-2.49|STANDARD_ERROR_OF_MEAN|0.657||0.0002||95.0|-3.78|-1.2|||ANCOVA|||||-1.20|-3.78|0.0002
70927827|NCT04753697|141350994|SUPERIORITY||DIFFERENCE IN LSM|-4.0|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-4.8|-3.2|||ANCOVA|||||-3.2|-4.8|<0.0001
70927828|NCT04753697|141350995|SUPERIORITY||DIFFERENCE IN LSM|-3.5|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001|TWO_SIDED|95.0|-4.5|-2.4|||ANCOVA|||||-2.4|-4.5|<0.0001
70927829|NCT04753697|141350995|SUPERIORITY||DIFFERENCE IN LSM|-3.1|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001|TWO_SIDED|95.0|-4.1|-2.1|||ANCOVA|||||-2.1|-4.1|<0.0001
70927830|NCT04753697|141350996|SUPERIORITY||DIFFERENCE IN LSM|-22.51|STANDARD_ERROR_OF_MEAN|1.528|<|0.0001|TWO_SIDED|95.0|-25.5|-19.51|||ANCOVA|||||-19.51|-25.50|<0.0001
70927831|NCT04753697|141350997|SUPERIORITY||DIFFERENCE IN LSM|-18.13|STANDARD_ERROR_OF_MEAN|1.9|<|0.0001|TWO_SIDED|95.0|-21.85|-14.4|||ANCOVA|||||-14.40|-21.85|<0.0001
70927832|NCT04753697|141350997|SUPERIORITY||DIFFERENCE IN LSM|-19.22|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|-22.9|-15.53|||ANCOVA|||||-15.53|-22.90|<0.0001
70927833|NCT04753697|141350998|SUPERIORITY||DIFFERENCE IN LSM|-25.4|STANDARD_ERROR_OF_MEAN|1.793|<|0.0001|TWO_SIDED|95.0|-28.92|-21.89|||ANCOVA|||||-21.89|-28.92|<0.0001
70927834|NCT04753697|141350999|SUPERIORITY||DIFFERENCE IN LSM|-20.82|STANDARD_ERROR_OF_MEAN|2.229|<|0.0001|TWO_SIDED|95.0|-25.17|-18.91|||Cochran-Mantel-Haenszel|||||-18.91|-25.17|<0.0001
70927835|NCT04753697|141350999|SUPERIORITY||DIFFERENCE IN LSM|-23.43|STANDARD_ERROR_OF_MEAN|2.222|<|0.0001|TWO_SIDED|95.0|-27.73|-21.56|||ANCOVA|||||-21.56|-27.73|<0.0001
71103501|NCT00863304|141714822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.23||0.009|TWO_SIDED|95.0|-1.07|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-1.07|0.009
71103502|NCT00863304|141714822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.23||0.011|TWO_SIDED|95.0|-1.05|-0.14||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.14|-1.05|0.011
71103503|NCT00863304|141714822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.23||0.035|TWO_SIDED|95.0|-0.95|-0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.03|-0.95|0.035
71103504|NCT00863304|141714822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.79|-0.85||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.85|-1.79|<0.001
71103505|NCT00863304|141714822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.71|-0.76||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.76|-1.71|<0.001
71103506|NCT00863304|141714822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.24||0.008|TWO_SIDED|95.0|-1.11|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-1.11|0.008
71103507|NCT00863304|141714822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.24||0.005|TWO_SIDED|95.0|-1.16|-0.21||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.21|-1.16|0.005
71103508|NCT00863304|141714822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.24||0.013|TWO_SIDED|95.0|-1.07|-0.12||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.12|-1.07|0.013
71103509|NCT00863304|141714822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.29|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.76|-0.81||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.81|-1.76|<0.001
71103510|NCT00863304|141714822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.11|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.58|-0.63||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.63|-1.58|<0.001
71103511|NCT00863304|141714822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.24||0.05|TWO_SIDED|95.0|-0.95|0.0||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.00|-0.95|0.050
71103512|NCT00863304|141714822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.29|-0.34||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.34|-1.29|<0.001
71103513|NCT00863304|141714822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.24||0.009|TWO_SIDED|95.0|-1.11|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-1.11|0.009
71103514|NCT00863304|141714823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.012|TWO_SIDED|95.0|-0.35|-0.04||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.04|-0.35|0.012
71103515|NCT00863304|141714823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.08||0.113|TWO_SIDED|95.0|-0.28|0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.03|-0.28|0.113
71103516|NCT00863304|141714823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.49|-0.18||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.18|-0.49|<0.001
71103517|NCT00863304|141714823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.08||0.076|TWO_SIDED|95.0|-0.01|0.29||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.29|-0.01|0.076
70927836|NCT04753697|141351000|SUPERIORITY||DIFFERENCE IN LSM|-4.1|STANDARD_ERROR_OF_MEAN|1.174||0.0005|TWO_SIDED|95.0|-6.4|-1.8|||ANCOVA|||||-1.80|-6.40|0.0005
70927837|NCT04753697|141351001|SUPERIORITY||DIFFERENCE IN LSM|-4.35|STANDARD_ERROR_OF_MEAN|1.42||0.0022|TWO_SIDED|95.0|-7.14|-1.57|||ANCOVA|||||-1.57|-7.14|0.0022
71103518|NCT00863304|141714823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.08||0.007|TWO_SIDED|95.0|0.06|0.37||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.37|0.06|0.007
71103519|NCT00863304|141714823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.56|-0.24||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.24|-0.56|<0.001
71103520|NCT00863304|141714823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.58|-0.26||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.26|-0.58|<0.001
71103521|NCT00863304|141714823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.43|-0.11||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.11|-0.43|<0.001
71103522|NCT00863304|141714823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.08||0.102|TWO_SIDED|95.0|-0.29|0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.03|-0.29|0.102
71103523|NCT00863304|141714823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.08||0.066|TWO_SIDED|95.0|-0.31|0.01||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.01|-0.31|0.066
71103524|NCT00863304|141714823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.6|-0.28||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.28|-0.60|<0.001
71103525|NCT00863304|141714823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.53|-0.21||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.21|-0.53|<0.001
71103526|NCT00863304|141714823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.027|TWO_SIDED|95.0|-0.34|-0.02||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.02|-0.34|0.027
70927838|NCT04753697|141351001|SUPERIORITY||Difference in LSM|-5.2|STANDARD_ERROR_OF_MEAN|1.425||0.0003|TWO_SIDED|95.0|-8.0|-2.41|||ANCOVA|||||-2.41|-8.00|0.0003
70927839|NCT04753697|141351002|SUPERIORITY||DIFFERENCE IN RESPONSE RATE AFTER MI (%)|16.9||||0.0016|TWO_SIDED|95.0|6.7|27.2|||ANCOVA|||||27.2|6.7|0.0016
70927840|NCT04947527|141351046|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.279|TWO_SIDED|95.0|-4.2|1.2|||t-test, 2 sided|||||1.2|-4.2|0.279
70927841|NCT04947527|141351047|SUPERIORITY||Difference in percentages/proportions|-14.4||||0.023|TWO_SIDED|95.0|-26.7|-2.1|||Chi-squared|||||-2.1|-26.7|0.023
70927842|NCT04947527|141351048|SUPERIORITY||Risk Difference (RD)|-0.09||||0.133|TWO_SIDED||||||Fisher Exact|||||||0.133
70927843|NCT02723591|141351049|SUPERIORITY||Odds Ratio (OR)|1.115||||0.5777|TWO_SIDED|95.0|0.76|1.636|||Regression, Logistic|||Logistic regression with DSA/IA occurrence by Month 12 as response, with treatment group, planned Campath use, KDPI level (as recorded in IVRS), HLA Class II mismatch, recipient age, recipient gender, recipient race, and pre-transplant calculated panel reactivity antibody (cPRA) as fixed effects, and pooled site as a random effect with standard variance components covariance type.||1.636|0.760|0.5777
70927844|NCT02723591|141351052|SUPERIORITY|||||||0.6618|||||||Fisher Exact|||P-values obtained from a 2x3 Exact Test of treatment by strength levels.||||0.6618
70927845|NCT02723591|141351057|SUPERIORITY||Odds Ratio (OR)|1.038||||0.8518|TWO_SIDED|95.0|0.7|1.539|||Regression, Logistic|||Logistic regression with IA occurrence by Month 12 as response, with treatment group, planned Campath use, KDPI level (as recorded in IVRS), HLA Class II mismatch, recipient age, recipient gender, recipient race, and pre-transplant cPRA as fixed effects, and pooled site as a random effect with standard Variance Components covariance type.||1.539|0.700|0.8518
70927846|NCT02723591|141351060|SUPERIORITY|||||||1|||||||Fisher Exact|||P-values obtained from a 2-sided Fisher's Exact Test of treatment arm by response.||||1.0000
70927847|NCT02723591|141351061|SUPERIORITY|||||||0.475|||||||Fisher Exact|||P-values obtained from a 2-sided Fisher's Exact Test of treatment arm by response.||||0.4750
70927848|NCT02723591|141351062|SUPERIORITY|||||||0.0939|||||||Fisher Exact|||P-values obtained from a 2-sided Fisher's Exact Test of treatment arm by response.||||0.0939
70927849|NCT02723591|141351065|SUPERIORITY||Odds Ratio (OR)|1.431||||0.116|TWO_SIDED|95.0|0.915|2.24|||Regression, Logistic|||Logistic regression with occurrence of eGFR \< 50 by Month 12 as response, with treatment group, planned Campath use, KDPI level (as recorded in IVRS), HLA Class II mismatch, recipient age, recipient gender, recipient race, and pre-transplant cPRA as fixed effects, and pooled site as a random effect with standard Variance Components covariance type.||2.240|0.915|0.1160
70927850|NCT02723591|141351066|SUPERIORITY||Odds Ratio (OR)|1.212||||0.4995|TWO_SIDED|95.0|0.693|2.12|||Regression, Logistic|||Logistic regression with occurrence of 5-point eGFR decline by Month 12 as response, with treatment group, planned Campath use, KDPI level (as recorded in IVRS), HLA Class II mismatch, recipient age, recipient gender, recipient race, and pre-transplant cPRA as fixed effects, and pooled site as a random effect with standard Variance Components covariance type.||2.120|0.693|0.4995
70927851|NCT02723591|141351084|SUPERIORITY|||||||0.6327|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.6327
70927852|NCT02723591|141351085|SUPERIORITY|||||||0.9701|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.9701
70927853|NCT02723591|141351086|SUPERIORITY|||||||0.3127|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.3127
70927854|NCT02723591|141351087|SUPERIORITY|||||||0.083|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.0830
70927855|NCT02723591|141351088|SUPERIORITY|||||||0.6022|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.6022
71010056|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|5.34|STANDARD_ERROR_OF_MEAN|2.36|||TWO_SIDED|95.0|0.45|10.22|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||10.22|0.45|
70927856|NCT02723591|141351089|SUPERIORITY|P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||||0.9249|||||||Fisher Exact|||||||0.9249
70927857|NCT02723591|141351090|SUPERIORITY|||||||0.9136|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.9136
70927858|NCT02723591|141351091|SUPERIORITY|||||||0.8789|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.8789
70927859|NCT02723591|141351092|SUPERIORITY|||||||0.5574|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.5574
70927860|NCT02723591|141351093|SUPERIORITY|||||||0.815|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.8150
70927861|NCT02723591|141351094|SUPERIORITY|||||||0.5673|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.5673
70927862|NCT04164888|141351136|SUPERIORITY||Least Square Mean|-84.56|STANDARD_ERROR_OF_MEAN|7.137|<|0.0001|TWO_SIDED|95.0|-98.95|-70.18|||ANCOVA|ANCOVA with LOCF||Applying the LOCF method (Last Observation Carried Forward) did not result in any changes at Day 29 or Day 57 due to the lack of missing values and resulted in similar results at Day 85.||-70.18|-98.95|<0.0001
71010057|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|1.67|STANDARD_ERROR_OF_MEAN|2.33|||TWO_SIDED|95.0|-3.17|6.52|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||6.52|-3.17|
70927863|NCT04164888|141351136|SUPERIORITY||Least Square Mean|-80.43|STANDARD_ERROR_OF_MEAN|7.018|<|0.0001|TWO_SIDED|95.0|-94.58|-66.29|||ANCOVA|ANCOVA with LOCF||Applying the LOCF method (Last Observation Carried Forward) did not result in any changes at Day 29 or Day 57 due to the lack of missing values and resulted in similar results at Day 85.||-66.29|-94.58|<0.0001
70927864|NCT04164888|141351136|SUPERIORITY||Least Square Mean|-84.87|STANDARD_ERROR_OF_MEAN|7.009|<|0.0001|TWO_SIDED|95.0|-99.0|-70.75|||ANCOVA|ANCOVA with LOCF||Applying the LOCF method (Last Observation Carried Forward) did not result in any changes at Day 29 or Day 57 due to the lack of missing values and resulted in similar results at Day 85.||-70.75|-99.00|<0.0001
70941336|NCT00676663|141383233|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.06|TWO_SIDED|95.0|0.49|1.09|||Log Rank|P-value is stratified by the randomization stratification factors and is 1-sided, with a 0.10 threshold for significance.||||1.09|0.49|0.06
70927865|NCT04164888|141351137|SUPERIORITY||Least Square Mean|-48.03|STANDARD_ERROR_OF_MEAN|7.46|<|0.0001|TWO_SIDED|95.0|-63.06|-32.99|||ANCOVA|ANCOVA with LOCF||Similar changes from baseline were observed for Day 29, Day 57, and Day 85 compared to Day 29, Day 57, and Day 85 LOCF.||-32.99|-63.06|<0.0001
70927866|NCT04164888|141351137|SUPERIORITY||Least Square Mean|-49.59|STANDARD_ERROR_OF_MEAN|7.396|<|0.0001|TWO_SIDED|95.0|-64.5|34.69|||ANCOVA|ANCOVA with LOCF||Similar changes from baseline were observed for Day 29, Day 57, and Day 85 compared to Day 29, Day 57, and Day 85 LOCF.||34.69|-64.50|<0.0001
70927867|NCT04164888|141351137|SUPERIORITY||Least Square Mean|-51.99|STANDARD_ERROR_OF_MEAN|7.616|<|0.0001|TWO_SIDED|95.0|-67.34|-36.64|||ANCOVA|ANCOVA with LOCF||Similar changes from baseline were observed for Day 29, Day 57, and Day 85 compared to Day 29, Day 57, and Day 85 LOCF.||-36.64|-67.34|<0.0001
70927868|NCT02696707|141351199|NON_INFERIORITY|The non-inferiority margin between groups was set as 4%|Difference|-0.6|||||TWO_SIDED|95.0|-2.5|1.2||||||||1.2|-2.5|
70927869|NCT03994653|141351251|SUPERIORITY||Odds Ratio (OR)|2.91|||<|0.001|TWO_SIDED|95.0|2.07|4.12|||Fisher Exact|||"Fishers exact test, conducted at each month prior to diagnosis comparing total purchases of relevant products (pain and indigestion medication) compared with all purchases in both cases and controls.~Power calculation: we used a power calculation assuming the Fisher Exact Test to calculate the minimum group size to detect a difference in purchase proportions that we hypothesised with 80% statistical power."||4.12|2.07|<0.001
70927870|NCT05034328|141351261|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70927871|NCT05034328|141351262|SUPERIORITY||Hazard Ratio (HR)|1.063||||0.7026|TWO_SIDED|95.0|0.778|1.451|||Regression, Cox|||For each item 2 to 7 of the WURSS-K questionnaire, the impact of the treament chosen on the corresponding common cold symptom duration was analyzed by means of Cox model and p-value (Wald) calculated||1.451|0.778|0.7026
71103527|NCT00863304|141714823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.08||0.001|TWO_SIDED|95.0|-0.42|-0.1||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.10|-0.42|0.001
71103528|NCT00863304|141714823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.08||0.02|TWO_SIDED|95.0|-0.35|-0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.03|-0.35|0.020
70927872|NCT05034328|141351263|SUPERIORITY||Hazard Ratio (HR)|1.078||||0.6322|TWO_SIDED|95.0|0.792|1.469|||Regression, Cox|||For each item 2 to 7 of the WURSS-K questionnaire, the impact of the treatment chosen on the corresponding common cold symptom duration was analyzed by means of Cox model and p-value (Wald) calculated||1.469|0.792|0.6322
70927873|NCT05034328|141351264|SUPERIORITY||Hazard Ratio (HR)|0.992||||0.9598|TWO_SIDED|95.0|0.726|1.356|||Regression, Cox|||For each item 2 to 7 of the WURSS-K questionnaire, the impact of the treatment chosen on the corresponding common cold symptom duration was analyzed by means of Cox model and p-value (Wald) calculated||1.356|0.726|0.9598
70927874|NCT05034328|141351265|SUPERIORITY||Hazard Ratio (HR)|1.333||||0.1016|TWO_SIDED|95.0|0.945|1.88|||Regression, Cox|||For each item 2 to 7 of the WURSS-K questionnaire, the impact of the treatment chosen on the corresponding common cold symptom duration was analyzed by means of Cox model and p-value (Wald) calculated||1.880|0.945|0.1016
70927875|NCT05034328|141351266|SUPERIORITY||Hazard Ratio (HR)|1.153||||0.3954|TWO_SIDED|95.0|0.83|1.601|||Regression, Cox|||For each item 2 to 7 of the WURSS-K questionnaire, the impact of the treatment chosen on the corresponding common cold symptom duration was analyzed by means of Cox model and p-value (Wald) calculated||1.601|0.830|0.3954
70927876|NCT05034328|141351267|SUPERIORITY||Hazard Ratio (HR)|1.218||||1.218|TWO_SIDED|95.0|0.871|1.703|||Regression, Cox|||For each item 2 to 7 of the WURSS-K questionnaire, the impact of the treatment chosen on the corresponding common cold symptom duration was analyzed by means of Cox model and p-value (Wald) calculated||1.703|0.871|1.218
70927877|NCT05034328|141351268|SUPERIORITY||||||>|0.05|||||||Regression, Logistic|||The impact of the treatment chosen on the risk to develop respiratory complication requiring antibiotic prescription during a 20-day follow-up was analyzed by a multivariate logistic model||||>0.05
70927878|NCT05034328|141351269|SUPERIORITY||Odds Ratio (OR)|0.335||||0.001|TWO_SIDED|95.0|0.174|0.644|||Regression, Logistic|||||0.644|0.174|0.0010
70927879|NCT05445427|141351270|SUPERIORITY|Groups were compared using Wilcoxon rank sum test.||||||0.544|||||||Wilcoxon (Mann-Whitney)|||||||0.544
70927880|NCT05445427|141351271|SUPERIORITY|||||||0.292|||||||ANCOVA|ANCOVA was used with the baseline value used as the covariate.||||||0.292
70927881|NCT02969707|141351272|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|2-sample t-test||Examining the Change in sum of positive z-transformed CC.||||0.035
70927882|NCT02969707|141351272|SUPERIORITY|||||||0.7||||||2-sample t-test|t-test, 2 sided|||Examining the change in sum of all z-transformed CC.||||0.7
70927883|NCT02969707|141351272|SUPERIORITY|2-sample t-test||||||0.11|||||||t-test, 2 sided|||Examining the change in sum of negative z-transformed CC.||||0.11
70927884|NCT02969707|141351272|SUPERIORITY||Mean Difference (Net)|61.98||||0.008|TWO_SIDED||||||t-test, 2 sided|One sample(paired) t-test||Examining the change in positive functional connectivity between the L-DLPFC and the dACC within the active group from pre to post TMS.||||0.008
70927885|NCT02969707|141351274|OTHER||Mann-Whitney U statistic|601.0||||0.046|TWO_SIDED||||||Mann-Whitney U-test 2-tailed|||Non-parametric analysis, comparison of change (post-treatment minus pre-treatment)||||0.046
71103529|NCT00863304|141714823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.49|-0.17||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.17|-0.49|<0.001
71103530|NCT00863304|141714823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.08||0.001|TWO_SIDED|95.0|-0.43|-0.11||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.11|-0.43|0.001
70927886|NCT02969707|141351274|OTHER||Cohen's R|0.25|||||TWO_SIDED||||||||Estimate of effect size|Non-parametric analysis, comparison of change (post-treatment minus pre-treatment)||||
70927887|NCT02969707|141351275|SUPERIORITY|We assessed the superiority of active over sham.|Mann-Whitney U statistic|702.5|||=|0.412|TWO_SIDED||||||Mann-Whitney U-test 2-tailed|||Pre- to post-rTMS change in HIS scores were calculated for both Active and Sham conditions. Two-tailed t-tests were used to evaluate the difference between the two conditions' change scores.||||=.412
70927888|NCT02969707|141351278|SUPERIORITY|||||||0.037|||||||t-test, 2 sided|2-sample t-test||||||0.037
70927889|NCT02969707|141351278|SUPERIORITY|||||||0.063|||||||t-test, 2 sided|||||||0.063
70927890|NCT02969707|141351278|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||||||0.31
70927891|NCT02969707|141351283|SUPERIORITY|We assessed the superiority of active over sham.|Cohen's d|-0.234||||0.49|TWO_SIDED||||||Mixed-effects model|||We used standard mixed-effects modeling to estimate the change (slope) in pain in our 2\*2 pre- and post-assessment design. Pain ratings were calculated by averaging pain ratings across 5 assessments under four conditions (TMS with hypnosis, TMS without hypnosis, Sham with hypnosis, Sham without hypnosis). Based on these change estimates, we derived the two main effects (TMS, Hypnosis) and their interaction effect on the change in pain from the pre- to post-treatment assessment.||||0.49
70927892|NCT02969707|141351284|SUPERIORITY|We assessed the superiority of active over sham.|||||=|0.454|||||||t-test, 2 sided|||Pre- to post-rTMS change in SOARS scores were calculated for both Active and Sham conditions. Two-tailed t-tests were used to evaluate the difference between the two conditions' change scores.||||=.454
70927893|NCT02969707|141351285|OTHER|Linear regression was used to evaluate the scalar relationship between E/I ratio as it relates to water and Thermal Pain Tolerance with E/I as the independent variable and Thermal Pain Tolerance as the dependent variable.||||||0.023|||||||Regression, Linear|(R² = .104, F(2,48) = 2.794, β = .320, p = .023)||In people with FMS, the linear relationship between Thermal Pain Tolerance and E/I ratio as it relates to water was assessed.||||0.023
70927894|NCT02969707|141351285|OTHER|Linear regression was used to evaluate the scalar relationship between E/I ratio as it relates to water and Thermal Pain Threshold with E/I as the independent variable and Thermal Pain Threshold as the dependent variable.||||||0.043|||||||Regression, Linear|(R² = .081, F(1,49) = 4.315, β = .284, p = .043)||In people with FMS, the linear relationship between Thermal Pain Threshold and E/I ratio as it relates to water was assessed.||||0.043
70927895|NCT02969707|141351285|OTHER|Linear regression was used to evaluate the scalar relationship between E/I ratio as it relates to creatine and Thermal Pain Tolerance with E/I as the independent variable and Thermal Pain Tolerance as the dependent variable.||||||0.022|||||||Regression, Linear|(R² = .103, F(1,49) = 5.632, β = .321, p = .022)||In people with FMS, the linear relationship between Thermal Pain Tolerance and E/I ratio as it relates to creatine was assessed.||||0.022
70927896|NCT02969707|141351285|OTHER|Linear regression was used to evaluate the scalar relationship between E/I ratio as it relates to creatine and Thermal Pain Threshold with E/I as the independent variable and Thermal Pain Threshold as the dependent variable.||||||0.041|||||||Regression, Linear|(R² = .083, F(1,49) = 4.425, β = .288, p = .041)||In people with FMS, the linear relationship between Thermal Pain Threshold and E/I ratio as it relates to creatine was assessed.||||0.041
70927897|NCT02969707|141351291|SUPERIORITY|||||||0.728|||||||ANCOVA|||Standard ANCOVA testing whether the Post-TMS E/I relative to creatine is predicted for each subject by the intervention (Active / Sham) while covarying for the Pre-TMS E/I ratio relative to creatine.||||0.728
70927898|NCT02969707|141351291|SUPERIORITY|||||||0.72|||||||ANCOVA|||Standard ANCOVA testing whether the Post-TMS E/I relative to water is predicted for each subject by the intervention (Active / Sham) while covarying for the Pre-TMS E/I ratio relative to water.||||0.720
70927899|NCT02714257|141351301|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.43|TWO_SIDED|95.0|0.74|1.14|||Regression, Cox||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||1.14|0.74|0.43
70927900|NCT02714257|141351302|SUPERIORITY||Incidence Rate Ratio|1.06||||0.5|TWO_SIDED|95.0|0.89|1.28|||Regression, Negative Binomial||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||1.28|0.89|0.50
70927901|NCT02714257|141351303|SUPERIORITY||Odds Ratio (OR)|0.89||||0.3|TWO_SIDED|95.0|0.72|1.11|||Regression, Logistic|||||1.11|0.72|0.30
70927902|NCT02714257|141351304|SUPERIORITY||Mean Difference (Final Values)|0.54|||<|0.01|TWO_SIDED|95.0|0.16|0.92|||Mixed Models Analysis||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||0.92|0.16|<0.01
70927903|NCT02714257|141351305|SUPERIORITY||Odds Ratio (OR)|1.04||||0.73|TWO_SIDED|95.0|0.85|1.27|||Regression, Logistic||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||1.27|0.85|0.73
70927904|NCT02714257|141351306|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.27|TWO_SIDED|95.0|-0.18|0.62|||Mixed Models Analysis||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||0.62|-0.18|0.27
70927905|NCT02714257|141351307|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.37|TWO_SIDED|95.0|-0.13|0.34|||Mixed Models Analysis||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||0.34|-0.13|0.37
70927906|NCT02714257|141351308|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.26|TWO_SIDED|95.0|-0.1|0.38|||Mixed Models Analysis||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||0.38|-0.10|0.26
70927907|NCT02714257|141351309|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.39|TWO_SIDED|95.0|-0.09|0.22|||Mixed Models Analysis||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||0.22|-0.09|0.39
70927908|NCT04103580|141351310|SUPERIORITY||Slope|0.005|STANDARD_ERROR_OF_MEAN|0.005||0.247|TWO_SIDED||||||Mixed Models Analysis|Due to uneven space between time points (days), we estimated a random effects model with varying intercepts and slopes for each phase independently.|We used an interaction between time and study arm to determine whether there was a significant difference over time in the change in outcome. The estimate is the difference in change over time for the intervention group compared to the control group.|The null hypothesis is that there is no difference between control and intervention over time in Phase 1.||||0.247
70927909|NCT04103580|141351310|SUPERIORITY||Slope|-0.008|STANDARD_ERROR_OF_MEAN|0.004||0.049|TWO_SIDED||||||Mixed Models Analysis|Due to uneven space between time points (days), we estimated a random effects model with varying intercepts and slopes for each phase independently.|We used an interaction between time and study arm to determine whether there was a significant difference over time in the change in outcome. The estimate is the difference in change over time for the intervention group compared to the control group.|The null hypothesis is that there is no difference between control and intervention over time in Phase 2.||||0.049
70927910|NCT04103580|141351311|SUPERIORITY||Slope|0.006|STANDARD_ERROR_OF_MEAN|0.004||0.15|TWO_SIDED||||||Mixed Models Analysis|Due to uneven space between time points (days), we estimated a random effects model with varying intercepts and slopes for each phase independently.|We used an interaction between time and study arm to determine whether there was a significant difference over time in the change in outcome. The estimate is the difference in change over time for the intervention group compared to the control group.|The null hypothesis is that there is no difference between control and intervention over time in Phase 1.||||0.150
70927911|NCT04103580|141351311|SUPERIORITY||Slope|-0.002|STANDARD_ERROR_OF_MEAN|0.004||0.635|TWO_SIDED||||||Mixed Models Analysis|Due to uneven space between time points (days), we estimated a random effects model with varying intercepts and slopes for each phase independently.|We used an interaction between time and study arm to determine whether there was a significant difference over time in the change in outcome. The estimate is the difference in change over time for the intervention group compared to the control group.|The null hypothesis is that there is no difference between control and intervention over time in Phase 2.||||0.635
70927912|NCT00104676|141351321|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.05|TWO_SIDED|95.0|0.44|1.0|||Log Rank|Adjusted on the stratification factor (treatment centers)||To detect an absolute difference of 20% in progression-free survival at 3-years between Arm I and Unfav-Dose-Dense Arm II (46% versus 66%) with the possibility that 80 events (progressive disease and death) may be observed during this period, a total of 196 participants, 98 per group needed to be included, with an additional 25% of patients for a total of 260 participants required.||1.00|0.44|0.05
70927913|NCT00104676|141351322|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.34|TWO_SIDED|95.0|0.46|1.31|||Log Rank|Adjusted on the stratification factor (treatment centers)||||1.31|0.46|0.34
70927914|NCT03084536|141351383|SUPERIORITY|||||||0.68|||||||Kruskal-Wallis|||||||0.68
70927915|NCT03084536|141351384|SUPERIORITY|||||||0.67|||||||Kruskal-Wallis|||||||0.67
70927916|NCT03084536|141351385|SUPERIORITY|||||||0.53|||||||Kruskal-Wallis|||||||0.53
70927917|NCT03084536|141351386|SUPERIORITY|||||||0.44|||||||Kruskal-Wallis|||||||0.44
70927918|NCT03084536|141351387|SUPERIORITY|||||||0.88|||||||Kruskal-Wallis|||||||0.88
70927919|NCT04285515|141351433|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|0.96|<|0.0001|TWO_SIDED|95.0|-7.6|-3.84|||Mixed Effects Model for Repeated Measure|||||-3.84|-7.60|<0.0001
71046295|NCT02508259|141600938|EQUIVALENCE|The child-specific difference in EOWPVT scores were compared for equivalence before and 6-weeks after suramin treatment|Mean Difference (Net)|-4.2|STANDARD_DEVIATION|8.3||0.32|TWO_SIDED|95.0|-14.5|6.1|||t-test, 2 sided|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.||6.1|-14.5|0.32
70927920|NCT04285515|141351434|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|1.33|<|0.0001|TWO_SIDED|95.0|-8.29|-3.05|||Mixed Effects Model for Repeated Measure|||||-3.05|-8.29|<0.0001
70927921|NCT04285515|141351435|SUPERIORITY||Least Squares Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|1.35|<|0.0001|TWO_SIDED|95.0|-8.61|-3.29|||Mixed Effects Model for Repeated Measure|||||-3.29|-8.61|<0.0001
70927922|NCT04285515|141351436|SUPERIORITY||Least Squares Mean Difference|-5.6|STANDARD_ERROR_OF_MEAN|0.86|<|0.0001|TWO_SIDED|95.0|-7.25|-3.88|||Mixed Effects Model for Repeated Measure|||||-3.88|-7.25|<0.0001
70927923|NCT04285515|141351437|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.81|-0.39|||Mixed Effects Model of Repeated Measure|||||-0.39|-0.81|<0.0001
70927924|NCT04285515|141351438|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.91|-0.31|||Mixed Effects Model for Repeated Measure|||||-0.31|-0.91|<0.0001
70927925|NCT04285515|141351439|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.16||0.0003|TWO_SIDED|95.0|-0.89|-0.27|||Mixed Effects Model for Repeated Measure|||||-0.27|-0.89|0.0003
70927926|NCT04285515|141351440|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.82|-0.44|||Mixed Effects Model for Repeated Measure|||||-0.44|-0.82|<0.0001
70927927|NCT01456949|141351463|SUPERIORITY||Kaplan-Meier (product-limit) estimator|66.9|||<|0.001|TWO_SIDED|95.0|61.6|71.7|||Exact binomial|Exact binomial p-value is shown, but the confidence intervals reported are calculated from Greenwood's approximation of the standard error.||||71.7|61.6|<0.001
70927928|NCT01456949|141351464|SUPERIORITY||Kaplan-Meier (product-limit) estimator|2.3|||<|0.001|TWO_SIDED|95.0|1.1|4.5|||Exact binomial|Exact binomial p-value is shown, but the confidence intervals reported are calculated from Greenwood's approximation of the standard error.||||4.5|1.1|<0.001
70927929|NCT01456949|141351465|OTHER|Secondary analyses were exploratory. No formal hypotheses or performance criteria were predefined.|||||||||||||||||Freedom from MAFE's was estimated using Kaplan-Meier methods.|||
70927930|NCT01456949|141351466|OTHER|Secondary analyses were exploratory. No formal hypotheses or performance criteria were predefined.|||||||||||||||||Chronic treatment success was estimated at one and two years using Kaplan-Meier methods.|||
70927931|NCT03785964|141351467|SUPERIORITY||Hazard Ratio (HR)|0.29|||<|0.001|TWO_SIDED|95.0|0.15|0.55|||Log Rank|p-value was from a one-sided stratified log-rank test with placebo as reference.||Hazard ratio was estimated from stratified Cox proportional hazards model using the exact method for ties, stratified by tumor location. Placebo was the reference treatment.||0.55|0.15|< 0.001
70927932|NCT03785964|141351468|SUPERIORITY||||||<|0.001||||||Two-sided p-value|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel test for general association stratified by tumor location. Placebo was reference treatment.||||< 0.001
70927933|NCT03785964|141351469|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|An unstructured covariance structure was used and degrees of freedom were estimated using the Kenward-Roger approximation.||Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline Brief Pain Inventory Short Form score and primary tumor location (intra-abdominal or extra-abdominal) as covariates, included baseline by visit and treatment by visit interactions. Only participants with a Baseline and at least one post-baseline score were included in the analysis. 40 and 31 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.||||<0.001
70927934|NCT03785964|141351470|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|An unstructured covariance structure was used and degrees of freedom were estimated using the Kenward-Roger approximation.||Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline DEsmoid Tumor Symptom Scale score and primary tumor location (intra-abdominal or extra-abdominal) as covariates, included baseline by visit and treatment by visit interactions. Only participants with a Baseline and at least one post-baseline score were included in the analysis. 40 and 32 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.||||<0.001
70927935|NCT03785964|141351471|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|An unstructured covariance structure was used and degrees of freedom were estimated using the Kenward-Roger approximation.||Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline score and primary tumor location (intra-abdominal or extra-abdominal) as covariates, included baseline by visit and treatment by visit interactions. Only participants with a Baseline and at least one post-baseline score were included in the analysis. 39 and 28 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.||||<0.001
70927936|NCT03785964|141351472|SUPERIORITY|||||||0.006|||||||Mixed Models Analysis|An unstructured covariance structure was used and degrees of freedom were estimated using the Kenward-Roger approximation.||Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline score and primary tumor location (intra-abdominal or extra-abdominal) as covariates, included baseline by visit and treatment by visit interactions. Only participants with a Baseline and at least one post-baseline score were included in the analysis. 38 and 27 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.||||0.006
70927937|NCT03785964|141351473|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|An unstructured covariance structure was used and degrees of freedom were estimated using the Kenward-Roger approximation.||Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline score and primary tumor location (intra-abdominal or extra-abdominal) as covariates, included baseline by visit and treatment by visit interactions. Only participants with a Baseline and at least one post-baseline score were included in the analysis. 38 and 28 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.||||<0.001
70927938|NCT03785964|141351474|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|An unstructured covariance structure was used and degrees of freedom were estimated using the Kenward-Roger approximation.||Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline score and primary tumor location (intra-abdominal or extra-abdominal) as covariates, included baseline by visit and treatment by visit interactions. Only participants with a Baseline and at least one post-baseline score were included in the analysis. 38 and 28 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.||||<0.001
70927939|NCT04176601|141351483|SUPERIORITY||Mean Difference (Net)|4.32|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|95.0|1.49|7.15||||||||7.15|1.49|
70927940|NCT04176601|141351484|SUPERIORITY||Mean Difference (Net)|4.7|STANDARD_ERROR_OF_MEAN|1.67|||TWO_SIDED|95.0|1.26|8.15||||||||8.15|1.26|
70927941|NCT04176601|141351485|SUPERIORITY||Mean Difference (Net)|3.68|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|1.59|6.14||||||||6.14|1.59|
70927942|NCT04201262|141351486|OTHER||Hazard Ratio (HR)|0.014|||<|0.0001|TWO_SIDED|95.0|0.0|0.103|||Log Rank||HR based on a Cox proportional hazards model, with Firth's adjustment. Confidence interval (CI)= Wald CI or Profile Likelihood CI Limits. HR for ravulizumab compared with placebo presented a 98.6% reduction in risk of relapse, 95% CI (89.7%, 100.0%).|||0.103|0.000|< 0.0001
70927943|NCT04201262|141351488|OTHER|||||||0.0122||||||Proportional Odds p-value|Univariate models|||The test of proportional odds was determined from a score test. The proportional odds was evaluated in univariate models.||||0.0122
70927944|NCT02618577|141351496|SUPERIORITY||adjusted cause-specific hazard ratio|0.81||||0.15|TWO_SIDED|95.0|0.6|1.08|||Cause-spec. Cox Proport. Hazard model|||||1.08|0.6|0.15
71046296|NCT02508259|141600939|EQUIVALENCE|In this analysis, the null hypothesis was tested that the child-specific ABC subscores for stereotypy were unchanged before and after suramin treatment.|Mean Difference (Net)|-4.0|STANDARD_DEVIATION|2.3||0.019|TWO_SIDED|95.0|-6.9|-1.1|||t-test, 2 sided|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.||-1.1|-6.9|0.019
71046297|NCT02508259|141600940|EQUIVALENCE|In this analysis, we tested the equivalence of the child-specific ATEC subscore for language before and 6-weeks after treatment with suramin.|Mean Difference (Net)|-2.0|STANDARD_DEVIATION|1.4||0.034|TWO_SIDED|95.0|-2.7|-0.49|||t-test, 2 sided|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.||-0.49|-2.7|0.034
70927945|NCT02618577|141351497|SUPERIORITY||adjusted cause-specific hazard ratio|0.79|||||TWO_SIDED|95.0|0.45|1.39||||||||1.39|0.45|
70927946|NCT02618577|141351498|SUPERIORITY||adjusted cause-specific hazard ratio|0.89|||||TWO_SIDED|95.0|0.67|1.18||||||||1.18|0.67|
70927947|NCT02618577|141351499|SUPERIORITY||adjusted cause-specific hazard ratio|1.16||||0.28|TWO_SIDED|95.0|0.88|1.53|||Cause-spec. Cox Proport. Hazard model|||||1.53|0.88|0.28
70927948|NCT02618577|141351500|SUPERIORITY||adjusted cause-specific hazard ratio|2.1||||0.002|TWO_SIDED|95.0|1.3|3.38|||Cause-spec. Cox Proport. Hazard model|||||3.38|1.3|0.002
70927949|NCT02618577|141351501|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.02|0.01|||||Estimation Parameter: baseline adjusted trial-group specific effect estimates (mean difference)|EQ-5D-5L UK Index||0.01|-0.02|
70927950|NCT02618577|141351501|SUPERIORITY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-1.46|1.38|||||Estimation Parameter: baseline adjusted trial-group specific effect estimates (mean difference)|EQ-5D-5L VAS, FU 24months||1.38|-1.46|
70927951|NCT02618577|141351501|SUPERIORITY||Mean Difference (Final Values)|0.27|||||TWO_SIDED|95.0|-0.56|1.09|||||Estimation Parameter: baseline adjusted trial-group specific effect estimates (mean difference)|Karnofsky score||1.09|-0.56|
70927952|NCT02618577|141351502|SUPERIORITY||Mean Difference (Final Values)|-0.12|||||TWO_SIDED|95.0|-1.12|0.87|||||Estimation Parameter: baseline adjusted trial-group specific effect estimates (mean difference)|PACT-Q convenience||0.87|-1.12|
70927953|NCT02618577|141351502|SUPERIORITY||Mean Difference (Final Values)|-1.04|||||TWO_SIDED|95.0|-2.6|0.52|||||Estimation Parameter: baseline adjusted trial-group specific effect estimates (mean difference)|PACT-Q satisfaction||0.52|-2.60|
70927954|NCT02618577|141351505|SUPERIORITY||adjusted cause-specific hazard ratio|0.51|||||TWO_SIDED|95.0|0.27|0.96||||||||0.96|0.27|
70927955|NCT02618577|141351506|SUPERIORITY||adjusted cause-specific hazard ratio|0.9|||||TWO_SIDED|95.0|0.62|1.31||||||||1.31|0.62|
70927956|NCT05446168|141351507|OTHER|A comparison is not being made between two different treatment groups. Exploratory analysis|Mean Difference (Net)|-0.08|STANDARD_DEVIATION|0.05||0.005|TWO_SIDED|95.0|-0.12|-0.03||A priori threshold for statistical significance is p \< 0.05.|t-test, 2 sided|t = -4.05, df = 7||||-0.03|-0.12|0.005
70927957|NCT05446168|141351508|OTHER|A comparison is not being made between two different treatment groups. Exploratory analysis.|Mean Difference (Net)|4.33|STANDARD_DEVIATION|12.81||0.27|TWO_SIDED|95.0|-3.81|12.47||A priori threshold for statistical significance is p \< 0.05.|t-test, 2 sided|t = 1.17, df = 11||||12.47|-3.81|0.27
70927958|NCT03511664|141351518|SUPERIORITY||Hazard Ratio (HR)|0.4|||<|0.001|TWO_SIDED|99.2|0.29|0.57|||Log Rank|one-sided stratified log-rank test||||0.57|0.29|< 0.001
70927959|NCT03511664|141351519|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.001|TWO_SIDED|95.0|0.52|0.74|||Log Rank|one-sided stratified log-rank test||Primary OS Analysis||0.74|0.52|<0.001
70927960|NCT03511664|141351519|SUPERIORITY||Cox Proportional Hazard|0.68|||||TWO_SIDED|95.0|0.58|0.81|||||Cox PH model stratified by LDH (≤260 vs. \>260 IU/L), liver metastases (yes/no), ECOG score (0-1 vs. 2), and NAAD inclusion in best supportive care at randomization (yes/no). IRT data used for stratification|Final OS analysis||0.81|0.58|
70927961|NCT03511664|141351521|SUPERIORITY||Odds Ratio (OR)|24.99|||<|0.001|TWO_SIDED|95.0|6.05|103.24|||Chi-squared|Two-sided Wald's Chi-square test (stratified)||||103.24|6.05|< 0.001
70927962|NCT03511664|141351522|SUPERIORITY||Odds Ratio (OR)|5.79|||<|0.001|TWO_SIDED|95.0|3.18|10.55|||Chi-squared|Two-sided Wald's Chi-square test (stratified)||||10.55|3.18|< 0.001
70927963|NCT03511664|141351524|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.4|0.62|||Log Rank|Two-sided stratified log-rank test||||0.62|0.40|< 0.001
70927964|NCT03511664|141351525|SUPERIORITY||Cox Proportional Hazard|0.3|||<|0.001|TWO_SIDED|95.0|0.24|0.38|||Log Rank|Two-sided stratified log-rank test||||0.38|0.24|< 0.001
70927965|NCT03511664|141351527|SUPERIORITY||Odds Ratio (OR)|11.19|||<|0.001|TWO_SIDED|95.0|6.3|20.0|||Chi-squared|Two-sided Wald's Chi-square test (stratified)||||20.0|6.3|< 0.001
70927966|NCT03511664|141351528|SUPERIORITY||Odds Ratio (OR)|23.6|||<|0.001|TWO_SIDED|95.0|8.6|65.1|||Chi-squared|Two-sided Wald's Chi-square test (stratified)||||65.1|8.6|< 0.001
70927967|NCT03221426|141351585|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.01501|TWO_SIDED|95.0|0.67|0.98||One-sided p-value based on log-rank test stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)|Log Rank||Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)|||0.98|0.67|0.01501
70927968|NCT03221426|141351586|SUPERIORITY||Difference in Percentage|11.4|||<|1e-05|TWO_SIDED|95.0|8.0|15.3|||Stratified Miettinen and Nurminen|Based on Miettinen \& Nurminen method stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)||||15.3|8.0|<0.00001
70927969|NCT03221426|141351587|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.07503|TWO_SIDED|95.0|0.71|1.06||One-sided p-value based on log-rank test stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)|Log Rank||Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)|||1.06|0.71|0.07503
70927970|NCT03221426|141351592|OTHER||Hazard Ratio (HR)|0.82||||0.04125|TWO_SIDED|95.0|0.65|1.03||One-sided p-value based on log-rank test with stratification|Log Rank||Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification|||1.03|0.65|0.04125
70927971|NCT03221426|141351593|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.04493|TWO_SIDED|95.0|0.71|1.03||One-sided p-value based on log-rank test stratified by geographic region (Asia vs. Non-Asia), tumor staging (II vs. III vs. IVa), and chemotherapy backbone (XP/FP vs. FLOT)|Log Rank||Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia vs. Non-Asia), tumor staging (II vs. III vs. IVa), and chemotherapy backbone (XP/FP vs. FLOT)|||1.03|0.71|0.04493
70927972|NCT03221426|141351594|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.00589|TWO_SIDED|95.0|0.67|0.95||One-sided p-value based on log-rank test stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)|Log Rank||Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)|||0.95|0.67|0.00589
70927973|NCT03257410|141351599|SUPERIORITY||Mean Difference (Final Values)|14.828|||||TWO_SIDED|95.0|10.501|19.156|||||Method=ANCOVA|If the lower bound of the two-sided 95% confidence interval around the difference between Theranova 400 and Elisio-17H is \> 0 then superiority will be demonstrated.||19.156|10.501|
70927974|NCT03257410|141351600|NON_INFERIORITY|If the lower bound of the two-sided 95% confidence interval around the mean estimated treatment difference between Theranova 400 and Elisio 17H is \> -0.1765 g/dL then non-inferiority can be claimed. If the lower bound of the two-sided 95% confidence interval is \> 0, then superiority may be concluded.|Mean Difference (Final Values)|-0.015|||||TWO_SIDED|95.0|-0.098|0.069|||ANCOVA|||||0.069|-0.098|
70927975|NCT03257410|141351601|OTHER||Mean Difference (Final Values)|19.42|STANDARD_ERROR_OF_MEAN|2.103|<|0.0001|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 4||||<0.0001
70927976|NCT03257410|141351601|OTHER||Mean Difference (Final Values)|16.1|STANDARD_ERROR_OF_MEAN|2.115|<|0.0001|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||<0.0001
70927977|NCT03257410|141351602|OTHER||Mean Difference (Final Values)|25.07|STANDARD_ERROR_OF_MEAN|4.3|<|0.0001|TWO_SIDED||||||MMRM|||Week 4||||<0.0001
70927978|NCT03257410|141351602|OTHER||Mean Difference (Final Values)|23.54|STANDARD_ERROR_OF_MEAN|2.0|<|0.0001|TWO_SIDED||||||MMRM|||Week 24||||<0.0001
70927979|NCT03257410|141351603|OTHER||Mean Difference (Final Values)|15.89|STANDARD_ERROR_OF_MEAN|2.73|<|0.0001|TWO_SIDED||||||MMRM|||Week 4||||<0.0001
70927980|NCT03257410|141351603|OTHER||Mean Difference (Final Values)|15.36|STANDARD_ERROR_OF_MEAN|2.479|<|0.0001|TWO_SIDED||||||MMRM|||Week 24||||<0.0001
70927981|NCT03257410|141351604|OTHER||Mean Difference (Final Values)|17.59|STANDARD_ERROR_OF_MEAN|9.583||0.0684|TWO_SIDED||||||MMRM|||Week 4||||0.0684
70927982|NCT03257410|141351604|OTHER||Mean Difference (Final Values)|13.98|STANDARD_ERROR_OF_MEAN|7.937||0.0806|TWO_SIDED||||||MMRM|||Week 24||||0.0806
70927983|NCT03257410|141351609|OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.033||0.0347|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 4||||0.0347
70927984|NCT03257410|141351609|OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.033||0.0036|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 8||||0.0036
71010058|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|4.03|STANDARD_ERROR_OF_MEAN|2.36|||TWO_SIDED|95.0|-0.86|8.92|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||8.92|-0.86|
71010059|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|4.05|STANDARD_ERROR_OF_MEAN|2.51|||TWO_SIDED|95.0|-1.18|9.27|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||9.27|-1.18|
70927985|NCT03257410|141351609|OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.04||0.129|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 12||||0.129
70927986|NCT03257410|141351609|OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.052||0.1149|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 16||||0.1149
70927987|NCT03257410|141351609|OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.044||0.0688|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 20||||0.0688
70927988|NCT03257410|141351609|OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.042||0.6097|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||0.6097
70927989|NCT03257410|141351610|OTHER||Mean Difference (Final Values)|-6.32|STANDARD_ERROR_OF_MEAN|4.336||0.1472|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 12||||0.1472
70927990|NCT03257410|141351610|OTHER||Mean Difference (Final Values)|-11.18|STANDARD_ERROR_OF_MEAN|7.154||0.1207|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||0.1207
70927991|NCT03257410|141351611|OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|2.488||0.9775|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 12||||0.9775
70927992|NCT03257410|141351611|OTHER||Mean Difference (Final Values)|1.72|STANDARD_ERROR_OF_MEAN|2.905||0.5538|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||0.5538
70927993|NCT03257410|141351612|OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.146||0.11|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 4||||0.1100
70927994|NCT03257410|141351612|OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.153||0.4607|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||0.4607
70927995|NCT03257410|141351613|OTHER||Mean Difference (Final Values)|-0.0787|STANDARD_ERROR_OF_MEAN|0.04454||0.0791|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 4||||0.0791
70927996|NCT03257410|141351613|OTHER||Mean Difference (Final Values)|-0.0027|STANDARD_ERROR_OF_MEAN|0.04302||0.9505|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 8||||0.9505
70927997|NCT03257410|141351613|OTHER||Mean Difference (Final Values)|-0.0615|STANDARD_ERROR_OF_MEAN|0.04271||0.1521|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 12||||0.1521
70927998|NCT03257410|141351613|OTHER||Mean Difference (Final Values)|0.0538|STANDARD_ERROR_OF_MEAN|0.04652||0.2489|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 16||||0.2489
70927999|NCT03257410|141351613|OTHER||Mean Difference (Final Values)|-0.0345|STANDARD_ERROR_OF_MEAN|0.05025||0.4936|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 20||||0.4936
70928000|NCT03257410|141351613|OTHER||Mean Difference (Final Values)|-0.0663|STANDARD_ERROR_OF_MEAN|0.0458||0.1497|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||0.1497
70928001|NCT03257410|141351614|OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|2.012||0.9001|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 12||||0.9001
70928002|NCT03257410|141351614|OTHER||Mean Difference (Final Values)|-2.33|STANDARD_ERROR_OF_MEAN|2.372||0.3279|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||0.3279
70928003|NCT03257410|141351615|OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.452||0.6576|TWO_SIDED||||||ANCOVA|||||||0.6576
70928004|NCT03257410|141351616|OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.104||0.0058|TWO_SIDED||||||ANCOVA|||||||0.0058
70928005|NCT03257410|141351617|OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.023||0.034|TWO_SIDED||||||ANCOVA|||||||0.034
70928006|NCT03257410|141351618|OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.071||0.0285|TWO_SIDED||||||ANCOVA|||||||0.0285
70928007|NCT03257410|141351619|OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.513||0.9069|TWO_SIDED||||||ANCOVA|||||||0.9069
70928008|NCT03257410|141351620|OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.443||0.8413|TWO_SIDED||||||ANCOVA|||||||0.8413
70928009|NCT03257410|141351621|OTHER||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.382||0.0125|TWO_SIDED||||||ANCOVA|||||||0.0125
70928010|NCT03257410|141351622|OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.561||0.6891|TWO_SIDED||||||ANCOVA|||||||0.6891
70928011|NCT03257410|141351623|OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.047||0.6043|TWO_SIDED||||||ANCOVA|||||||0.6043
70928012|NCT03257410|141351624|OTHER||Mean Difference (Final Values)|1.39|STANDARD_ERROR_OF_MEAN|2.08||0.5067|TWO_SIDED||||||ANCOVA|||||||0.5067
70928013|NCT03257410|141351625|OTHER||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.009||0.0297|TWO_SIDED||||||ANCOVA|||||||0.0297
70928014|NCT03257410|141351626|OTHER||Mean Difference (Final Values)|3.24|STANDARD_ERROR_OF_MEAN|2.14||0.1325|TWO_SIDED||||||ANCOVA|||||||0.1325
70928015|NCT03257410|141351627|OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.186||0.2304|TWO_SIDED||||||ANCOVA|||||||0.2304
70928016|NCT03257410|141351628|OTHER||Mean Difference (Final Values)|-1.59|STANDARD_ERROR_OF_MEAN|2.846||0.5785|TWO_SIDED||||||ANCOVA|||||||0.5785
70928017|NCT03257410|141351629|OTHER||Mean Difference (Final Values)|2.55|STANDARD_ERROR_OF_MEAN|0.918||0.0067|TWO_SIDED||||||ANCOVA|||||||0.0067
70928018|NCT03257410|141351630|OTHER||Mean Difference (Final Values)|-14.93|STANDARD_ERROR_OF_MEAN|7.314||0.0434|TWO_SIDED||||||ANCOVA|||||||0.0434
70928019|NCT03257410|141351631|OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.07||0.3281|TWO_SIDED||||||ANCOVA|||||||0.3281
70928020|NCT03257410|141351632|OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.334||0.0463|TWO_SIDED||||||ANCOVA|||||||0.0463
71103531|NCT00863304|141714823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.08||0.328|TWO_SIDED|95.0|-0.24|0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.08|-0.24|0.328
70928021|NCT03257410|141351633|OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.06||0.1925|TWO_SIDED||||||ANCOVA|||||||0.1925
70928022|NCT03257410|141351634|OTHER||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.389||0.2569|TWO_SIDED||||||ANCOVA|||||||0.2569
70928023|NCT03257410|141351635|OTHER||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|1.104||0.5709|TWO_SIDED||||||ANCOVA|||||||0.5709
70928024|NCT03257410|141351636|OTHER||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.412||0.217|TWO_SIDED||||||ANCOVA|||||||0.217
70928025|NCT03257410|141351637|OTHER||Mean Difference (Final Values)|-1.53|STANDARD_ERROR_OF_MEAN|1.292||0.2386|TWO_SIDED||||||ANCOVA|||||||0.2386
70928026|NCT03257410|141351638|OTHER||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|0.84||0.1769|TWO_SIDED||||||ANCOVA|||||||0.1769
70928027|NCT03257410|141351639|OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.36||0.8102|TWO_SIDED||||||ANCOVA|||||||0.8102
70928028|NCT03257410|141351640|OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|1.501||0.9672|TWO_SIDED||||||ANCOVA|||||||0.9672
70928029|NCT03257410|141351641|OTHER||Mean Difference (Final Values)|27.34|STANDARD_ERROR_OF_MEAN|24.623||0.2697|TWO_SIDED||||||ANCOVA|||||||0.2697
70928030|NCT03257410|141351644|OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.115||0.7189|TWO_SIDED||||||ANCOVA|||||||0.7189
70928031|NCT03257410|141351645|OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.044||0.097|TWO_SIDED||||||ANCOVA|||||||0.097
70928032|NCT03257410|141351646|OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.113||0.4513|TWO_SIDED||||||ANCOVA|||||||0.4513
70928033|NCT03257410|141351647|OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.1||0.0733|TWO_SIDED||||||ANCOVA|||||||0.0733
70928034|NCT03257410|141351648|OTHER||Mean Difference (Final Values)|-3.42|STANDARD_ERROR_OF_MEAN|5.467||0.5326|TWO_SIDED||||||ANCOVA|||||||0.5326
70928035|NCT03257410|141351649|OTHER||Mean Difference (Final Values)|-1.11|STANDARD_ERROR_OF_MEAN|1.076||0.3042|TWO_SIDED||||||ANCOVA|||||||0.3042
70928036|NCT03257410|141351650|OTHER||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.976||0.5534|TWO_SIDED||||||ANCOVA|||||||0.5534
70928037|NCT03257410|141351651|OTHER||Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|1.181||0.2958|TWO_SIDED||||||ANCOVA|||||||0.2958
70928038|NCT03257410|141351652|OTHER||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.377||0.0998|TWO_SIDED||||||ANCOVA|||||||0.0998
70928039|NCT03257410|141351653|OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|3.176||0.9952|TWO_SIDED||||||ANCOVA|||||||0.9952
70928040|NCT03257410|141351654|OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.693||0.3063|TWO_SIDED||||||ANCOVA|||||||0.3063
70928041|NCT03257410|141351655|OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.529||0.1098|TWO_SIDED||||||ANCOVA|||||||0.1098
70928042|NCT03257410|141351656|OTHER||Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|0.797||0.0766|TWO_SIDED||||||ANCOVA|||||||0.0766
70928043|NCT03257410|141351657|OTHER||Mean Difference (Final Values)|-2.58|STANDARD_ERROR_OF_MEAN|2.41||0.2886|TWO_SIDED||||||ANCOVA|||||||0.2886
70928044|NCT03257410|141351658|OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.042||0.4513|TWO_SIDED||||||ANCOVA|||||||0.4513
70928045|NCT03257410|141351659|OTHER||Mean Difference (Final Values)|1.56|STANDARD_ERROR_OF_MEAN|2.96||0.5992|TWO_SIDED||||||ANCOVA|||||||0.5992
70928046|NCT03257410|141351660|OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.29||0.3836|TWO_SIDED||||||ANCOVA|||||||0.3836
71103532|NCT00863304|141714823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.08||0.002|TWO_SIDED|95.0|-0.41|-0.09||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.09|-0.41|0.002
70928047|NCT03257410|141351661|OTHER||Mean Difference (Final Values)|-13.07|STANDARD_ERROR_OF_MEAN|7.284||0.0769|TWO_SIDED||||||ANCOVA|||||||0.0769
70928048|NCT03257410|141351662|OTHER||Mean Difference (Final Values)|-19.56|STANDARD_ERROR_OF_MEAN|5.17||0.0002|TWO_SIDED||||||ANCOVA|||||||0.0002
70928049|NCT03257410|141351663|OTHER||Mean Difference (Final Values)|-1.39|STANDARD_ERROR_OF_MEAN|1.039||0.1825|TWO_SIDED||||||ANCOVA|||||||0.1825
70928050|NCT03257410|141351664|OTHER||Mean Difference (Final Values)|-1.24|STANDARD_ERROR_OF_MEAN|0.737||0.0957|TWO_SIDED||||||ANCOVA|||||||0.0957
70928051|NCT03257410|141351665|OTHER||Mean Difference (Final Values)|-34.02|STANDARD_ERROR_OF_MEAN|10.23||0.0012|TWO_SIDED||||||ANCOVA|||||||0.0012
70928052|NCT03257410|141351666|OTHER||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|0.859||0.1824|TWO_SIDED||||||ANCOVA|||||||0.1824
70928053|NCT02561247|141351667|OTHER|||||||0.0008||||||P Value is from a one sample t-test compared against the null hypothesis value|t-test, 1 sided|Null Hypothesis Value = -38; Degrees of Freedom=16; t-value=-4.13||P Value is from a one sample t-test compared against the null hypothesis value. No adjustments were made for multiple comparisons/multiplicity in this study, since there was only one primary endpoint, one arm, and one pre-specified primary null hypothesis.||||0.0008
70928054|NCT03435614|141351679|OTHER||||||||||||||||||We selected the individual signs and symptoms associated with the presence of OIWS based on a difference of greater than 15 % in the assessments between the group with OIWS and the group not displaying OIWS. This 15 % difference was judged to be of clinical significance. The signs and symptoms which did not meet this difference were not considered (data not available).|||
70928055|NCT03526887|141351701|SUPERIORITY||Median Difference (Net)|9.7||||0.016|TWO_SIDED|95.0|9.4|19.1|||Log Rank|||||19.1|9.4|0.016
70928056|NCT03656510|141351766|OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-1.382|0.185||||||Difference versus placebo in mean RSV viral load AUC on Day 3||0.185|-1.382|
70928057|NCT03656510|141351766|OTHER||Mean Difference (Final Values)|-0.39|||||TWO_SIDED|95.0|-1.19|0.418||||||Difference versus placebo in mean RSV viral load AUC on Day 3||0.418|-1.190|
70928058|NCT03656510|141351766|OTHER||Mean Difference (Final Values)|-2.46|||||TWO_SIDED|95.0|-4.674|-0.25||||||Difference versus placebo in mean RSV viral load AUC on Day 8||-0.250|-4.674|
70928059|NCT03656510|141351766|OTHER||Mean Difference (Final Values)|-2.38|||||TWO_SIDED|95.0|-4.645|-0.114||||||Difference versus placebo in mean RSV viral load AUC on Day 8||-0.114|-4.645|
70928060|NCT05698875|141351818|OTHER||Fixed effects parameter|1.0||||0.12|TWO_SIDED|95.0|0.1|1.9||P=0.04 however was adjusted using the Bonferroni correction The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL vs control meals||1.9|0.1|0.12
70928061|NCT05698875|141351818|OTHER||Fixed effects parameter|-0.58||||0.23|TWO_SIDED|95.0|-1.5|0.4||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP vs control meal||0.4|-1.5|0.23
70928062|NCT05698875|141351818|OTHER||Fixed effects parameter|0.24||||0.62|TWO_SIDED|95.0|-0.7|1.2||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL vs control meal||1.2|-0.7|0.62
70928063|NCT05698875|141351818|OTHER||Fixed effects parameter|1.6||||0.003|TWO_SIDED|95.0|0.7|2.5||Above is adjusted p value using Bonferroni correction. The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL vs HGLP||2.5|0.7|0.003
70928064|NCT05698875|141351818|OTHER||Fixed effects parameter|0.82||||0.08|TWO_SIDED|95.0|-0.1|1.7||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL vs MGL meals||1.7|-0.1|0.08
70928065|NCT05698875|141351818|OTHER||Fixed effects parameter|-0.8||||0.12|TWO_SIDED|95.0|-1.7|0.2||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP vs MGL meals||0.2|-1.7|0.12
70928066|NCT05698875|141351819|OTHER||Mean Difference (Final Values)|0.835||||0.08|TWO_SIDED|95.0|-0.1|1.8||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL vs control meals||1.8|-0.1|0.08
70928067|NCT05698875|141351819|OTHER||Mean Difference (Final Values)|-0.7||||0.13|TWO_SIDED|95.0|-1.7|0.2||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP meal vs control meal||0.2|-1.7|0.13
70928068|NCT05698875|141351819|OTHER||Mean Difference (Final Values)|-0.2||||0.68|TWO_SIDED|95.0|-1.2|0.8||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meals vs control meals||0.8|-1.2|0.68
70928069|NCT05698875|141351819|OTHER||Mean Difference (Final Values)|1.6|||<|0.01|TWO_SIDED|95.0|0.7|2.5||The a priori threshold for statistical significance p\<0.05 P value adjusted with Bonferroni correction|Linear Mixed Model|||HGL vs HGLP meals||2.5|0.7|<0.01
70928070|NCT05698875|141351819|OTHER||Mean Difference (Final Values)|1.1||||0.06|TWO_SIDED|95.0|0.2|2.0||The a priori threshold for statistical significance p\<0.05 p value adjusted with the Bonferroni correction|Linear Mixed Model|||HGL vs MGL meals||2.0|0.2|0.06
70928071|NCT05698875|141351819|OTHER||Mean Difference (Final Values)|-0.5||||0.29|TWO_SIDED|95.0|-1.4|0.4||a priori threshold for statistical significance - P\<0.05|Linear Mixed Model|||HGLP vs MGL meals||0.4|-1.4|0.29
70928072|NCT05698875|141351820|OTHER||Mean Difference (Final Values)|1.9|||<|0.01|TWO_SIDED|95.0|0.8|3.0||The a priori threshold for statistical significance p\<0.05 Adjusted p value with Bonferroni correction|Linear Mixed Model|||HGL meals vs control meals||3.0|0.8|<0.01
70928073|NCT05698875|141351820|OTHER||Mean Difference (Final Values)|-0.3||||0.59|TWO_SIDED|95.0|-1.4|0.8||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||0.8|-1.4|0.59
70928074|NCT05698875|141351820|OTHER||Mean Difference (Final Values)|-0.1||||0.86|TWO_SIDED|95.0|-1.2|1.0||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||MGL meals vs control meals||1.0|-1.2|0.86
70928075|NCT05698875|141351820|OTHER||Mean Difference (Final Values)|2.3|||<|0.001|TWO_SIDED|95.0|1.2|3.3||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni did not alter p value|Linear Mixed Model|||HGL vs HGLP meals||3.3|1.2|<0.001
70928076|NCT05698875|141351820|OTHER||Mean Difference (Final Values)|2.1|||<|0.001|TWO_SIDED|95.0|1.1|3.1||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni correction did not alter p value|Linear Mixed Model|||HGL vs MGL meals||3.1|1.1|<0.001
70928077|NCT05698875|141351820|OTHER||Mean Difference (Final Values)|-0.1||||0.79|TWO_SIDED|95.0|-1.2|0.9||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP vs MGL meals||0.9|-1.2|0.79
70928078|NCT05698875|141351821|OTHER||Mean Difference (Final Values)|-8.5||||0.31|TWO_SIDED|95.0|-25.0|8.0||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGL meals vs control meals||8|-25|0.31
70928079|NCT05698875|141351821|OTHER||Mean Difference (Final Values)|-24.4||||0.03|TWO_SIDED|95.0|-41.0|-8.0||A priori threshold for statistical significance is p\<0.05 P adjusted using Bonferroni correction|Linear Mixed Model|||HGLP meals vs control meals||-8|-41|0.03
70928080|NCT05698875|141351821|OTHER||Mean Difference (Final Values)|12.7||||0.14|TWO_SIDED|95.0|-4.1|29.5||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||MGL meals vs control meals||29.5|-4.1|0.14
70928081|NCT05698875|141351821|OTHER||Mean Difference (Final Values)|17.0||||0.34|TWO_SIDED|95.0|3.1|31.7||A priori threshold P \<0.05 P value adjusted with Bonferroni correction|Linear Mixed Model|||HGL vs HGLP meals||31.7|3.1|0.34
70928082|NCT05698875|141351821|OTHER||Mean Difference (Final Values)|-19.0||||0.07|TWO_SIDED|95.0|-33.3|-4.7||A priori threshold for statistical significance is p\<0.05 Adjusted P value with Bonferroni correction|Linear Mixed Model|||HGL vs MGL meals||-4.7|-33.3|0.07
70928083|NCT05698875|141351821|OTHER||Mean Difference (Final Values)|-36.4|||<|0.001|TWO_SIDED|95.0|-51.0|-21.8||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni did not alter p value|Linear Mixed Model|||HGLP vs MGL meals||-21.8|-51.0|<0.001
70928084|NCT05698875|141351822|OTHER||Mean Difference (Final Values)|151.0||||0.25|TWO_SIDED|95.0|7.0|294.0||A priori threshold for statistical significance is p\<0.05 Adjusted p value with Bonferroni correction|Linear Mixed Model|||HGL meals vs control meals||294|7|0.25
70928085|NCT05698875|141351822|OTHER||Mean Difference (Final Values)|-109.0||||0.15|TWO_SIDED|95.0|-256.0|38.0||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||38|-256|0.15
70928086|NCT05698875|141351822|OTHER||Mean Difference (Final Values)|-30.0||||0.69|TWO_SIDED|95.0|-177.0|117.0||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||MGL meals vs control meals||117|-177|0.69
71103533|NCT00863304|141714823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.08||0.022|TWO_SIDED|95.0|-0.35|-0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.03|-0.35|0.022
70928087|NCT05698875|141351822|OTHER||Mean Difference (Final Values)|264.0|||<|0.001|TWO_SIDED|95.0|126.0|401.0||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni did not alter p value|Linear Mixed Model|||HGL vs HGLP meals||401|126|<0.001
71010060|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|3.76|STANDARD_ERROR_OF_MEAN|2.47|||TWO_SIDED|95.0|-1.38|8.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||8.90|-1.38|
70928088|NCT05698875|141351822|OTHER||Mean Difference (Final Values)|192.0||||0.02|TWO_SIDED|95.0|56.0|329.0||A priori threshold for statistical significance is p\<0.05 P value adjusted with Bonferroni correction|Linear Mixed Model|||HGL vs MGL meals||329|56|0.02
70928089|NCT05698875|141351822|OTHER||Mean Difference (Final Values)|-71.0||||0.32|TWO_SIDED|95.0|-211.0|69.0||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP vs MGL meals||69|-211|0.32
71010061|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|5.18|STANDARD_ERROR_OF_MEAN|3.31|||TWO_SIDED|95.0|-1.7|12.06|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||12.06|-1.70|
71103534|NCT00863304|141714824|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.012|TWO_SIDED|95.0|-0.35|-0.04||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.04|-0.35|0.012
70928090|NCT05698875|141351823|OTHER||Mean Difference (Final Values)|6.9|||<|0.01|TWO_SIDED|95.0|3.3|10.4||A priori threshold for statistical significance is p\<0.05 P value adjusted with Bonferroni correction|Linear Mixed Model|||HGL meals vs control meals||10.4|3.3|<0.01
70928091|NCT05698875|141351823|OTHER||Mean Difference (Final Values)|3.5||||0.06|TWO_SIDED|95.0|-0.2|7.2||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||7.2|-0.2|0.06
70928092|NCT05698875|141351823|OTHER||Mean Difference (Final Values)|0.32||||0.86|TWO_SIDED|95.0|-3.3|3.9||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||MGL meals vs control meals||3.9|-3.3|0.86
70928093|NCT05698875|141351823|OTHER||Mean Difference (Final Values)|3.4||||0.11|TWO_SIDED|95.0|0.24|6.48||A priori threshold for statistical significance is p\<0.05 P value adjusted with the Bonferroni correction|Linear Mixed Model|||HGL vs HGLP meals||6.48|0.24|0.11
70928094|NCT05698875|141351823|OTHER||Mean Difference (Final Values)|6.7|||<|0.001|TWO_SIDED|95.0|3.6|9.8||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni did not alter p value|Linear Mixed Model|||HGL vs MGL meals||9.8|3.6|<0.001
70928095|NCT05698875|141351823|OTHER||Mean Difference (Final Values)|3.3||||0.13|TWO_SIDED|95.0|0.2|6.5||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni correction|Linear Mixed Model|||HGLP vs MGL meals||6.5|0.2|0.13
70928096|NCT05698875|141351824|OTHER||Mean Difference (Final Values)|-34.8||||0.01|TWO_SIDED|95.0|-55.9|-13.6||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni correction|Linear Mixed Model|||HGL meals vs control meal||-13.6|-55.9|0.01
70928097|NCT05698875|141351824|OTHER||Mean Difference (Final Values)|-1.8||||0.87|TWO_SIDED|95.0|-23.6|19.9||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||19.9|-23.6|0.87
70928098|NCT05698875|141351824|OTHER||Mean Difference (Final Values)|-4.7||||0.67|TWO_SIDED|95.0|-26.4|17.0||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||MGL meals vs control meals||17.0|-26.4|0.67
70928099|NCT05698875|141351824|OTHER||Mean Difference (Final Values)|-33.3||||0.01|TWO_SIDED|95.0|-54.4|-12.2||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni correction|Linear Mixed Model|||HGL vs HGLP meals||-12.2|-54.4|0.01
70928100|NCT05698875|141351824|OTHER||Mean Difference (Final Values)|-31.4||||0.01|TWO_SIDED|95.0|-52.4|-10.4||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni correction|Linear Mixed Model|||HGL vs MGL meals||-10.4|-52.4|0.01
70928101|NCT05698875|141351824|OTHER||Mean Difference (Final Values)|1.86||||0.87|TWO_SIDED|95.0|-19.7|23.4||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP vs MGL meals||23.4|-19.7|0.87
70928102|NCT05698875|141351825|OTHER||Mean Difference (Final Values)|34.0||||0.04|TWO_SIDED|95.0|2.0|65.0|||t-test, 2 sided|||Control vs HGL meals||65|2|0.04
70928103|NCT05698875|141351825|OTHER||Mean Difference (Final Values)|6.0||||0.56|TWO_SIDED|95.0|-17.0|30.0|||t-test, 2 sided|||Control vs HGLP meals||30|-17|0.56
70928104|NCT05698875|141351825|OTHER||Mean Difference (Final Values)|12.0||||0.22|TWO_SIDED|95.0|8.0|32.0|||t-test, 2 sided|||Control vs MGL meals||32|8|0.22
70928105|NCT05698875|141351825|OTHER||Mean Difference (Final Values)|38.0||||0.01|TWO_SIDED|95.0|10.0|67.0|||t-test, 2 sided|||HGL vs HGLP meals||67|10|0.01
70928106|NCT05698875|141351825|OTHER||Mean Difference (Final Values)|33.0||||0.03|TWO_SIDED|95.0|4.0|62.0|||t-test, 2 sided|||HGL vs MGL meals||62|4|0.03
70928107|NCT05698875|141351825|OTHER||Mean Difference (Final Values)|-5.0||||0.63|TWO_SIDED|95.0|-29.0|18.0|||t-test, 2 sided|||HGLP vs MGL meals||18|-29|0.63
70928108|NCT05698875|141351826|OTHER||Mean Difference (Final Values)|22.0||||0.16|TWO_SIDED|95.0|10.0|53.0|||t-test, 2 sided|||Control vs HGL meals||53|10|0.16
70928109|NCT05698875|141351826|OTHER||Mean Difference (Final Values)|21.0||||0.11|TWO_SIDED|95.0|5.0|46.0|||t-test, 2 sided|||Control vs HGLP meals||46|5|0.11
70928110|NCT05698875|141351826|OTHER||Mean Difference (Final Values)|19.0||||0.15|TWO_SIDED|95.0|8.0|45.0|||t-test, 2 sided|||Control vs MGL meals||45|8|0.15
70928111|NCT05698875|141351826|OTHER||Mean Difference (Final Values)|44.0|||<|0.01|TWO_SIDED|95.0|16.0|71.0|||t-test, 2 sided|||HGL vs HGLP meals||71|16|<0.01
70928112|NCT05698875|141351826|OTHER||Mean Difference (Final Values)|-7.0||||0.6|TWO_SIDED|95.0|-36.0|21.0|||t-test, 2 sided|||HGL vs MGL meals||21|-36|0.60
70928113|NCT05698875|141351826|OTHER||Mean Difference (Final Values)|29.0||||0.02|TWO_SIDED|95.0|6.0|51.0|||t-test, 2 sided|||HGLP vs MGL meals||51|6|0.02
70928114|NCT05698875|141351827|OTHER||Mean Difference (Final Values)|1.6|||<|0.001|TWO_SIDED|95.0|0.8|2.4||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meal excursion vs Control meal at 30 minutes||2.4|0.8|<0.001
70928115|NCT05698875|141351827|OTHER||Mean Difference (Final Values)|0.4||||0.38|TWO_SIDED|95.0|-0.5|1.2|||Linear Mixed Model|||HGLP meal vs Control meal glucose excursion at 30 minutes||1.2|-0.5|0.38
70928116|NCT05698875|141351827|OTHER||Mean Difference (Final Values)|-0.3||||0.47|TWO_SIDED|95.0|-1.1|0.5||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meal excursion vs Control meal at 30 minutes||0.5|-1.1|0.47
70928117|NCT05698875|141351827|OTHER||Mean Difference (Final Values)|1.2||||0.01|TWO_SIDED|95.0|0.5|2.0||a priori threshold for statistical significance p\<0.05 P value adjusted with Bonferroni correction|Linear Mixed Model|||HGL meal vs HGLP meal||2.0|0.5|0.01
70928118|NCT05698875|141351827|OTHER||Mean Difference (Final Values)|1.9|||<|0.001|TWO_SIDED|95.0|1.1|2.6||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meal vs MGL meals||2.6|1.1|<0.001
70928119|NCT05698875|141351827|OTHER||Mean Difference (Final Values)|0.7||||0.09|TWO_SIDED|95.0|0.1|1.4||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP meals vs MGL meals||1.4|0.1|0.09
70928120|NCT05698875|141351828|OTHER||Mean Difference (Final Values)|1.9|||<|0.001|TWO_SIDED|95.0|0.7|3.0||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meals vs control meals||3.0|0.7|<0.001
70928121|NCT05698875|141351828|OTHER||Mean Difference (Final Values)|-0.1||||0.87|TWO_SIDED|95.0|-1.2|1.0||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||1.0|-1.2|0.87
70928122|NCT05698875|141351828|OTHER||Mean Difference (Final Values)|-0.4||||0.48|TWO_SIDED|95.0|-1.5|0.7||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meals vs control meals||0.7|-1.5|0.48
70928123|NCT05698875|141351828|OTHER||Mean Difference (Final Values)|2.0|||<|0.001|TWO_SIDED|95.0|1.0|3.1||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meals vs HGLP meals||3.1|1.0|<0.001
70928124|NCT05698875|141351828|OTHER||Mean Difference (Final Values)|2.4|||<|0.001|TWO_SIDED|95.0|1.3|3.4||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meals vs MGL meals||3.4|1.3|<0.001
70928125|NCT05698875|141351828|OTHER||Mean Difference (Final Values)|-0.34||||0.53|TWO_SIDED|95.0|-1.4|0.7||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meals vs HGLP meals||0.7|-1.4|0.53
70928126|NCT05698875|141351829|OTHER||Mean Difference (Final Values)|1.3||||0.06|TWO_SIDED|95.0|-0.03|2.7||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meals vs control meals||2.7|-0.03|0.06
70928127|NCT05698875|141351829|OTHER||Mean Difference (Final Values)|-1.1||||0.13|TWO_SIDED|95.0|-2.5|0.3||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||0.3|-2.5|0.13
70928128|NCT05698875|141351829|OTHER||Mean Difference (Final Values)|-0.2||||0.82|TWO_SIDED|95.0|-1.5|1.2||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meals vs control meals||1.2|-1.5|0.82
70928129|NCT05698875|141351829|OTHER||Mean Difference (Final Values)|2.4|||<|0.01|TWO_SIDED|95.0|1.1|3.7||a priori threshold for statistical significance p\<0.05 Adjusted with Bonferroni correction|Linear Mixed Model|||HGL meals vs MGL meals||3.7|1.1|<0.01
70928130|NCT05698875|141351829|OTHER||Mean Difference (Final Values)|1.5||||0.08|TWO_SIDED|95.0|0.2|2.9||a priori threshold for statistical significance p\<0.05 Adjusted with Bonferroni correction|Linear Mixed Model|||HGL meals vs MGL meals||2.9|0.2|0.08
70928131|NCT05698875|141351829|OTHER||Mean Difference (Final Values)|0.9||||0.21|TWO_SIDED|95.0|-0.5|2.2||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meals vs HGLP meals||2.2|-0.5|0.21
70928132|NCT05698875|141351830|OTHER||Mean Difference (Final Values)|0.8||||0.31|TWO_SIDED|95.0|-0.7|2.2||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meals vs control meals||2.2|-0.7|0.31
70928133|NCT05698875|141351830|OTHER||Mean Difference (Final Values)|-1.5||||0.05|TWO_SIDED|95.0|-3.0|-0.1||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||-0.1|-3.0|0.05
70928134|NCT05698875|141351830|OTHER||Mean Difference (Final Values)|0.03||||0.97|TWO_SIDED|95.0|-1.5|1.5||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meals vs control meals||1.5|-1.5|0.97
70928135|NCT05698875|141351830|OTHER||Mean Difference (Final Values)|2.3|||<|0.01|TWO_SIDED|95.0|1.0|3.6||a priori threshold for statistical significance p\<0.05 Adjusted with Bonferroni correction|Linear Mixed Model|||HGL meals vs HGLP meals||3.6|1.0|<0.01
70928136|NCT05698875|141351830|OTHER||Mean Difference (Final Values)|0.8||||0.27|TWO_SIDED|95.0|0.6|2.2||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meals vs MGL meals||2.2|0.6|0.27
70928137|NCT05698875|141351830|OTHER||Mean Difference (Final Values)|1.5||||0.12|TWO_SIDED|95.0|0.1|3.0||a priori threshold for statistical significance \<0.05 Adjusted with p value|Linear Mixed Model|||MGL meals vs HGLP meals||3.0|0.1|0.12
71103535|NCT00863304|141714824|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.08||0.113|TWO_SIDED|95.0|-0.28|0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.03|-0.28|0.113
70928138|NCT05698875|141351831|OTHER||Mean Difference (Final Values)|-0.2||||0.83|TWO_SIDED|95.0|-1.5|1.2||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||HGL meals vs control meals||1.2|-1.5|0.83
70928139|NCT05698875|141351831|OTHER||Mean Difference (Final Values)|-1.5||||0.09|TWO_SIDED|95.0|-2.9|-0.2||a priori threshold for statistical significance \<0.05 Adjusted with Bonferroni correction|Linear Mixed Model|||HGLP meals vs control meals||-0.2|-2.9|0.09
70928140|NCT05698875|141351831|OTHER||Mean Difference (Final Values)|-0.2||||0.78|TWO_SIDED|95.0|-1.6|1.2||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||MGL meals vs control meals||1.2|-1.6|0.78
70928141|NCT05698875|141351831|OTHER||Mean Difference (Final Values)|1.4||||0.11|TWO_SIDED|95.0|0.1|2.7||a priori threshold for statistical significance \<0.05 Adjusted with Bonferroni correction|Linear Mixed Model|||HGL meals vs HGLP meals||2.7|0.1|0.11
70928142|NCT05698875|141351831|OTHER||Mean Difference (Final Values)|-0.2||||0.82|TWO_SIDED|95.0|-1.5|1.1||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||MGL meals vs HGL meals||1.1|-1.5|0.82
70928143|NCT05698875|141351831|OTHER||Mean Difference (Final Values)|1.3||||0.06|TWO_SIDED|95.0|-0.1|2.6||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||MGL meals vs HGLP meals||2.6|-0.1|0.06
70928144|NCT05698875|141351832|OTHER||Mean Difference (Final Values)|0.1||||0.85|TWO_SIDED|95.0|-1.1|1.3||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||HGL meals vs control meals||1.3|-1.1|0.85
70928145|NCT05698875|141351832|OTHER||Mean Difference (Final Values)|-1.2||||0.06|TWO_SIDED|95.0|-2.4|0.04||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||HGLP meals vs control meals||0.04|-2.4|0.06
70928146|NCT05698875|141351832|OTHER||Mean Difference (Final Values)|-0.08||||0.9|TWO_SIDED|95.0|-1.3|1.2||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||MGL meals vs control meals||1.2|-1.3|0.90
70928147|NCT05698875|141351832|OTHER||Mean Difference (Final Values)|1.4||||0.05|TWO_SIDED|95.0|0.3|2.5||a priori threshold for statistical significance \<0.05 Adjusted with Bonferroni correction|Linear Mixed Model|||HGL meals vs HGLP meals||2.5|0.3|0.05
71103536|NCT00863304|141714824|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.49|-0.18||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.18|-0.49|<0.001
70928148|NCT05698875|141351832|OTHER||Mean Difference (Final Values)|0.34||||0.55|TWO_SIDED|95.0|-0.8|1.5||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||HGL meals vs MGL meals||1.5|-0.8|0.55
70928149|NCT05698875|141351832|OTHER||Mean Difference (Final Values)|1.1||||0.08|TWO_SIDED|95.0|-0.1|2.2||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||MGL meals vs HGLP meals||2.2|-0.1|0.08
70928150|NCT05196919|141351875|SUPERIORITY||Mean Difference (Final Values)|4.2|STANDARD_ERROR_OF_MEAN|8.693||1|TWO_SIDED|95.0|-22.57|30.97|||Mixed Models Analysis|||This was a phase 2a safety study that was not statistically powered for efficacy assessments.||30.97|-22.57|1.00
70928151|NCT05196919|141351875|SUPERIORITY||Mean Difference (Final Values)|7.96|STANDARD_ERROR_OF_MEAN|8.142||0.99|TWO_SIDED|95.0|-17.12|33.03|||Mixed Models Analysis|||This was a phase 2a safety study that was not statistically powered for efficacy assessments.||33.03|-17.12|0.99
70928152|NCT05196919|141351876|SUPERIORITY||Mean Difference (Final Values)|-6.15|STANDARD_ERROR_OF_MEAN|4.676||0.1933|TWO_SIDED|95.0|-15.49|3.19|||Mixed Models Analysis|||This was a phase 2a safety study that was not statistically powered for efficacy assessments.||3.19|-15.49|0.1933
70928153|NCT05196919|141351876|SUPERIORITY||Mean Difference (Final Values)|5.14|STANDARD_ERROR_OF_MEAN|4.434||0.2511|TWO_SIDED|95.0|-3.73|14.0|||Mixed Models Analysis|||This was a phase 2a safety study that was not statistically powered for efficacy assessments.||14.00|-3.73|0.2511
70928154|NCT03621371|141351940|OTHER||F-test|9.88|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
71010062|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|5.61|STANDARD_ERROR_OF_MEAN|3.25|||TWO_SIDED|95.0|-1.14|12.37|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||12.37|-1.14|
71103537|NCT00863304|141714824|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.08||0.076|TWO_SIDED|95.0|-0.01|0.29||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.29|-0.01|0.076
70928155|NCT01959607|141351941|OTHER||Geometric LS Mean Ratio|103.5|||||TWO_SIDED|95.0|84.94|126.11|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (THS 2.2 - Group 1:CC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of THS 2.2:CC) for Cmax, therefore, there was no statistical hypothesis to be tested for this objective.||126.11|84.94|
70928156|NCT01959607|141351942|OTHER||Geometric LS Mean Ratio|96.34|||||TWO_SIDED|95.0|85.1|109.07|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (THS 2.2 - Group 1:CC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of THS 2.2:CC) for AUC(0-last), therefore, there was no statistical hypothesis to be tested for this objective.||109.07|85.10|
70928157|NCT01658930|141351979|NON_INFERIORITY|Margin of inferiority in the difference of 3 year pelvic recurrence rates between simple and radical hysterectomy group was 4%.|Mean Difference (Final Values)|0.0035|||||TWO_SIDED|90.0|-0.0162|0.0232|||||Difference between simple and radical hysterectomy groups.|||0.0232|-0.0162|
70928158|NCT01658930|141351980|SUPERIORITY||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.47|2.67|||||Hazard ratio of simple to radical hysterectomy.|||2.67|0.47|
70928159|NCT01658930|141351981|SUPERIORITY||Hazard Ratio (HR)|3.82|||||TWO_SIDED|95.0|0.79|18.4|||||Hazard ratio is simple hysterectomy group of radical hysterectomy group.|||18.4|0.79|
70928160|NCT01658930|141351982|SUPERIORITY||Hazard Ratio (HR)|1.54|||||TWO_SIDED|95.0|0.69|3.45|||||Hazard ratio is simple hysterectomy group to radical hysterectomy group.|||3.45|0.69|
70928161|NCT01658930|141351983|SUPERIORITY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.38|3.14|||||Hazard ratio of simple to radical hysterectomy.|||3.14|0.38|
71010063|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|-0.21|STANDARD_ERROR_OF_MEAN|2.47|||TWO_SIDED|95.0|-5.35|4.92|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||4.92|-5.35|
71103538|NCT00863304|141714824|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.08||0.007|TWO_SIDED|95.0|0.06|0.37||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.37|0.06|0.007
71103539|NCT00863304|141714824|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.57|-0.26||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.26|-0.57|<0.001
71103540|NCT00863304|141714824|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.57|-0.25||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.25|-0.57|<0.001
70928162|NCT03701763|141351984|SUPERIORITY||Percentage Adjusted Difference|21.7|||<|0.0001|TWO_SIDED|95.0|11.2|32.1|||Cochran-Mantel-Haenszel|||||32.1|11.2|<0.0001
70928163|NCT03701763|141351985|SUPERIORITY||Percentage Adjusted Difference|29.4|||<|0.0001|TWO_SIDED|95.0|17.8|40.9|||Cochran-Mantel-Haenszel|||||40.9|17.8|<0.0001
70928164|NCT03701763|141351986|SUPERIORITY||Percentage Adjusted Difference|38.4|||<|0.0001|TWO_SIDED|95.0|25.6|51.2|||Cochran-Mantel-Haenszel|||||51.2|25.6|<0.0001
70928165|NCT03701763|141351987|SUPERIORITY||Difference in Least Squares Mean|-26.97|STANDARD_ERROR_OF_MEAN|4.572|<|0.0001|TWO_SIDED|95.0|-35.93|-18.0|||ANCOVA|||||-18.00|-35.93|<0.0001
70928166|NCT03701763|141351988|SUPERIORITY||Difference in Least Squares Mean|-34.77|STANDARD_ERROR_OF_MEAN|6.229|<|0.0001|TWO_SIDED|95.0|-46.99|-22.55|||ANCOVA|||||-22.55|-46.99|< 0.0001
70928167|NCT03701763|141351989|SUPERIORITY||Percentage Adjusted Difference|4.1||||0.5616|TWO_SIDED|95.0|-9.8|18.0|||Cochran-Mantel-Haenszel|||||18.0|-9.8|0.5616
70928168|NCT03701763|141351990|SUPERIORITY||Difference in Least Squares Mean|-1.8||||0.0009|TWO_SIDED|95.0|-2.9|-0.8|||ANCOVA|||||-0.8|-2.9|0.0009
70928169|NCT02589795|141352026|OTHER|Inequality test|||||>|0.05|||||||Fisher Exact|||The proportions of subjects with primary safety outcomes were compared in a pairwise manner between the three randomised groups, using Fisher's exact tests.||||>0.05
70928170|NCT02589795|141352027|OTHER|Inequality test|||||>|0.05|||||||Kruskal-Wallis|Kruskal-Wallis test with Dunn's correction for multiple comparisons||Kruskal-Wallis test with Dunn's correction for multiple comparisons to compare the levels of antigen-specific serum IgG in the three groups at Week 22.||||>0.05
70928171|NCT04909801|141352034|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9026|TWO_SIDED|95.0|0.6|1.6|||Regression, Logistic|||||1.6|0.6|0.9026
70928172|NCT04909801|141352035|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.5824|TWO_SIDED|95.0|0.5|1.5|||Regression, Logistic|||||1.5|0.5|0.5824
70928173|NCT04909801|141352036|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.3534||95.0|0.5|1.3|||Regression, Logistic|||||1.3|0.5|0.3534
70928174|NCT04909801|141352037|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.614|TWO_SIDED|95.0|0.5|1.5|||Regression, Logistic|||||1.5|0.5|0.6140
70928175|NCT04909801|141352039|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4996|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|||Day 29||1.4|0.5|0.4996
70928176|NCT04909801|141352039|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.449|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|||Day 57||1.4|0.5|0.4490
71103541|NCT00863304|141714824|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.45|-0.13||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.13|-0.45|<0.001
71103542|NCT00863304|141714824|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.08||0.12|TWO_SIDED|95.0|-0.29|0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.03|-0.29|0.120
70928177|NCT04909801|141352039|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.809|TWO_SIDED|95.0|0.5|1.7|||Regression, Logistic|||Day 85||1.7|0.5|0.8090
70928178|NCT04909801|141352039|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.9||||0.0739|TWO_SIDED|95.0|0.9|3.6|||Regression, Logistic|||Day 113||3.6|0.9|0.0739
70928179|NCT04909801|141352039|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.3||||0.4201|TWO_SIDED|95.0|0.7|2.6|||Regression, Logistic|||Day 141||2.6|0.7|0.4201
70928180|NCT04909801|141352039|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.7928|TWO_SIDED|95.0|0.6|2.0|||Regression, Logistic|||Day 169||2.0|0.6|0.7928
70928181|NCT04909801|141352040|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.7||||0.2701|TWO_SIDED|95.0|0.4|1.3|||Regression, Logistic|||Day 29||1.3|0.4|0.2701
70928182|NCT04909801|141352040|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4863|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|||Day 57||1.4|0.5|0.4863
71103543|NCT00863304|141714824|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.08||0.126|TWO_SIDED|95.0|-0.29|0.04||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.04|-0.29|0.126
70928183|NCT04909801|141352040|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9513|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|||Day 85||1.7|0.6|0.9513
70928184|NCT04909801|141352040|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.8536|TWO_SIDED|95.0|0.6|1.8|||Regression, Logistic|||Day 113||1.8|0.6|0.8536
70928185|NCT04909801|141352040|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9223|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|||Day 141||1.7|0.6|0.9223
70928186|NCT04909801|141352040|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9026|TWO_SIDED|95.0|0.6|1.6|||Regression, Logistic|||Day 169||1.6|0.6|0.9026
70928187|NCT04909801|141352041|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.6||||0.3411|TWO_SIDED|95.0|0.2|1.6|||Regression, Logistic|||Day 29||1.6|0.2|0.3411
70928188|NCT04909801|141352041|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.7||||0.2546|TWO_SIDED|95.0|0.4|1.3|||Regression, Logistic|||Day 57||1.3|0.4|0.2546
70928189|NCT04909801|141352041|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4558|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|||Day 85||1.4|0.5|0.4558
70928190|NCT04909801|141352041|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9544|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|||Day 113||1.7|0.6|0.9544
70928191|NCT04909801|141352041|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.545|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|||Day 141||1.4|0.5|0.5450
70928192|NCT04909801|141352041|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.7||||0.2227|TWO_SIDED|95.0|0.4|1.2|||Regression, Logistic|||Day 169||1.2|0.4|0.2227
70928193|NCT04909801|141352042|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.7||||0.32|TWO_SIDED|95.0|0.3|1.4|||Regression, Logistic|||Day 29||1.4|0.3|0.3200
70928194|NCT04909801|141352042|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4992|TWO_SIDED|95.0|0.5|1.5|||Regression, Logistic|||Day 57||1.5|0.5|0.4992
70928195|NCT04909801|141352042|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.8963|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|||Day 85||1.7|0.6|0.8963
70928196|NCT04909801|141352042|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4544|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|||Day 113||1.4|0.5|0.4544
70928197|NCT04909801|141352042|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.8985|TWO_SIDED|95.0|0.6|1.8|||Regression, Logistic|||Day 141||1.8|0.6|0.8985
70928198|NCT04909801|141352042|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.5824|TWO_SIDED|95.0|0.5|1.5|||Regression, Logistic|||Day 169||1.5|0.5|0.5824
70928199|NCT04909801|141352043|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.5||||0.4152|TWO_SIDED|95.0|0.6|4.1|||Regression, Logistic|||Day 29||4.1|0.6|0.4152
70928200|NCT04909801|141352043|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.2||||0.5917|TWO_SIDED|95.0|0.6|2.5|||Regression, Logistic|||Day 57||2.5|0.6|0.5917
70928201|NCT04909801|141352043|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.4||||0.3348|TWO_SIDED|95.0|0.7|2.6|||Regression, Logistic|||Day 85||2.6|0.7|0.3348
70928202|NCT04909801|141352043|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.3959|TWO_SIDED|95.0|0.4|1.4|||Regression, Logistic|||Day 113||1.4|0.4|0.3959
70928203|NCT04909801|141352043|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.2||||0.6225|TWO_SIDED|95.0|0.7|2.0|||Regression, Logistic|||Day 141||2.0|0.7|0.6225
70928204|NCT04909801|141352043|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.614|TWO_SIDED|95.0|0.5|1.5|||Regression, Logistic|||Day 169||1.5|0.5|0.6140
70928205|NCT04909801|141352044|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.8084|TWO_SIDED|95.0|0.4|2.9|||Regression, Logistic|||Day 29||2.9|0.4|0.8084
70928206|NCT04909801|141352044|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.747|TWO_SIDED|95.0|0.5|2.3|||Regression, Logistic|||Day 57||2.3|0.5|0.7470
70928207|NCT04909801|141352044|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.2||||0.5233|TWO_SIDED|95.0|0.7|2.3|||Regression, Logistic|||Day 85||2.3|0.7|0.5233
70928208|NCT04909801|141352044|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.7295|TWO_SIDED|95.0|0.5|1.6|||Regression, Logistic|||Day 113||1.6|0.5|0.7295
71103544|NCT00863304|141714824|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.62|-0.3||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.30|-0.62|<0.001
70928209|NCT04909801|141352044|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.7621|TWO_SIDED|95.0|0.6|1.9|||Regression, Logistic|||Day 141||1.9|0.6|0.7621
70928210|NCT04909801|141352044|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.6861|TWO_SIDED|95.0|0.5|1.6|||Regression, Logistic|||Day 169||1.6|0.5|0.6861
70928211|NCT04909801|141352045|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.3117|TWO_SIDED|95.0|0.5|1.2|||Regression, Logistic|||Day 29||1.2|0.5|0.3117
71103545|NCT00863304|141714824|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.57|-0.25||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.25|-0.57|<0.001
71103546|NCT00863304|141714824|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.08||0.003|TWO_SIDED|95.0|-0.41|-0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.08|-0.41|0.003
70928212|NCT04909801|141352045|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.612|TWO_SIDED|95.0|0.6|1.4|||Regression, Logistic|||Day 57||1.4|0.6|0.6120
70928213|NCT04909801|141352045|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4339|TWO_SIDED|95.0|0.5|1.3|||Regression, Logistic|||Day 85||1.3|0.5|0.4339
70928214|NCT04909801|141352045|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.5||||0.1963|TWO_SIDED|95.0|0.8|2.6|||Regression, Logistic|||Day 113||2.6|0.8|0.1963
71010064|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|1.61|STANDARD_ERROR_OF_MEAN|2.42|||TWO_SIDED|95.0|-3.42|6.65|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||6.65|-3.42|
71010065|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|5.08|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|-1.19|11.36|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||11.36|-1.19|
71010066|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|5.3|STANDARD_ERROR_OF_MEAN|2.94|||TWO_SIDED|95.0|-0.83|11.42|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||11.42|-0.83|
70928215|NCT04909801|141352045|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.3||||0.3275|TWO_SIDED|95.0|0.8|2.3|||Regression, Logistic|||Day 141||2.3|0.8|0.3275
70928216|NCT04909801|141352045|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9113|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|||Day 169||1.7|0.6|0.9113
70928217|NCT04909801|141352046|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.7||||0.1247|TWO_SIDED|95.0|0.4|1.1|||Regression, Logistic|||Day 29||1.1|0.4|0.1247
70928218|NCT04909801|141352046|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.5656|TWO_SIDED|95.0|0.6|1.4|||Regression, Logistic|||Day 57||1.4|0.6|0.5656
70928219|NCT04909801|141352046|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.897|TWO_SIDED|95.0|0.6|1.5|||Regression, Logistic|||Day 85||1.5|0.6|0.8970
70928220|NCT04909801|141352046|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9175|TWO_SIDED|95.0|0.7|1.6|||Regression, Logistic|||Day 113||1.6|0.7|0.9175
70928221|NCT04909801|141352046|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.5996|TWO_SIDED|95.0|0.7|1.7|||Regression, Logistic|||Day 141||1.7|0.7|0.5996
70928222|NCT04909801|141352046|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.3534|TWO_SIDED|95.0|0.5|1.3|||Regression, Logistic|||Day 169||1.3|0.5|0.3534
70928223|NCT04909801|141352047|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.6||||0.1641|TWO_SIDED|95.0|0.2|1.3|||Regression, Logistic|||Day 29||1.3|0.2|0.1641
70928224|NCT04909801|141352047|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.5905|TWO_SIDED|95.0|0.5|1.5|||Regression, Logistic|||Day 57||1.5|0.5|0.5905
70928225|NCT04909801|141352047|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.7146|TWO_SIDED|95.0|0.6|1.5|||Regression, Logistic|||Day 85||1.5|0.6|0.7146
70928226|NCT04909801|141352047|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.7416|TWO_SIDED|95.0|0.7|1.7|||Regression, Logistic|||Day 113||1.7|0.7|0.7416
70928227|NCT04909801|141352047|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9026|TWO_SIDED|95.0|0.6|1.5|||Regression, Logistic|||Day 141||1.5|0.6|0.9026
70928228|NCT04909801|141352047|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.2605|TWO_SIDED|95.0|0.5|1.2|||Regression, Logistic|||Day 169||1.2|0.5|0.2605
70928229|NCT04909801|141352048|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.6||||0.1078|TWO_SIDED|95.0|0.3|1.1|||Regression, Logistic|||Day 29||1.1|0.3|0.1078
70928230|NCT04909801|141352048|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.7||||0.1855|TWO_SIDED|95.0|0.4|1.2|||Regression, Logistic|||Day 57||1.2|0.4|0.1855
70928231|NCT04909801|141352048|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.5223|TWO_SIDED|95.0|0.6|1.4|||Regression, Logistic|||Day 85||1.4|0.6|0.5223
71103547|NCT00863304|141714824|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.009|TWO_SIDED|95.0|-0.38|-0.05||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.05|-0.38|0.009
71103548|NCT00863304|141714824|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.052|TWO_SIDED|95.0|-0.32|0.0||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.00|-0.32|0.052
70928232|NCT04909801|141352048|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4078|TWO_SIDED|95.0|0.5|1.3|||Regression, Logistic|||Day 113||1.3|0.5|0.4078
70928233|NCT04909801|141352048|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.2||||0.5238|TWO_SIDED|95.0|0.7|1.8|||Regression, Logistic|||Day 141||1.8|0.7|0.5238
70928234|NCT04909801|141352048|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.474|TWO_SIDED|95.0|0.5|1.3|||Regression, Logistic|||Day 169||1.3|0.5|0.4740
70928235|NCT04909801|141352049|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.2||||0.6565|TWO_SIDED|95.0|0.5|2.9|||Regression, Logistic|||Day 29||2.9|0.5|0.6565
70928236|NCT04909801|141352049|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.701|TWO_SIDED|95.0|0.6|2.1|||Regression, Logistic|||Day 57||2.1|0.6|0.7010
70928237|NCT04909801|141352049|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.3||||0.3683|TWO_SIDED|95.0|0.8|2.1|||Regression, Logistic|||Day 85||2.1|0.8|0.3683
70928238|NCT04909801|141352049|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.6372|TWO_SIDED|95.0|0.7|1.8|||Regression, Logistic|||Day 113||1.8|0.7|0.6372
70928239|NCT04909801|141352049|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.3||||0.2922|TWO_SIDED|95.0|0.8|2.0|||Regression, Logistic|||Day 141||2.0|0.8|0.2922
70928240|NCT04909801|141352049|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.8178|TWO_SIDED|95.0|0.7|1.7|||Regression, Logistic|||Day 169||1.7|0.7|0.8178
70928241|NCT04909801|141352050|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9599|TWO_SIDED|95.0|0.4|2.2|||Regression, Logistic|||Day 29||2.2|0.4|0.9599
70928242|NCT04909801|141352050|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.7899|TWO_SIDED|95.0|0.5|1.7|||Regression, Logistic|||Day 57||1.7|0.5|0.7899
70928243|NCT04909801|141352050|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.6305|TWO_SIDED|95.0|0.7|1.9|||Regression, Logistic|||Day 85||1.9|0.7|0.6305
70928244|NCT04909801|141352050|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.3||||0.3491|TWO_SIDED|95.0|0.8|2.0|||Regression, Logistic|||Day 113||2.0|0.8|0.3491
70928245|NCT04909801|141352050|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.2||||0.4916|TWO_SIDED|95.0|0.7|1.9|||Regression, Logistic|||Day 141||1.9|0.7|0.4916
70928246|NCT04909801|141352050|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.5697|TWO_SIDED|95.0|0.7|1.8|||Regression, Logistic|||Day 169||1.8|0.7|0.5697
70928247|NCT04909801|141352051|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.2||||0.0977|TWO_SIDED|95.0|0.0|0.5|||longitudinal|||Day 29||0.5|-0.0|0.0977
70928248|NCT04909801|141352051|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.2||||0.2889|TWO_SIDED|95.0|-0.1|0.5|||longitudinal|||Day 57||0.5|-0.1|0.2889
70928249|NCT04909801|141352051|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.0||||0.7676|TWO_SIDED|95.0|-0.3|0.4|||longitudinal|||Day 85||0.4|-0.3|0.7676
70928250|NCT04909801|141352051|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-0.1||||0.6157|TWO_SIDED|95.0|-0.3|0.2|||longitudinal|||Day 113||0.2|-0.3|0.6157
70928251|NCT04909801|141352051|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-0.1||||0.3904|TWO_SIDED|95.0|-0.4|0.2|||longitudinal|||Day 141||0.2|-0.4|0.3904
70928252|NCT04909801|141352051|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.0||||0.8359|TWO_SIDED|95.0|-0.4|0.3|||longitudinal|||Day 169||0.3|-0.4|0.8359
70928253|NCT04909801|141352052|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.4||||0.7852|TWO_SIDED|95.0|-2.3|3.1|||longitudinal|||Day 29||3.1|-2.3|0.7852
70928254|NCT04909801|141352052|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.6||||0.6336|TWO_SIDED|95.0|-2.0|3.3|||longitudinal|||Day 57||3.3|-2.0|0.6336
70928255|NCT04909801|141352052|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-0.9||||0.4879|TWO_SIDED|95.0|-3.5|1.7|||longitudinal|||Day 85||1.7|-3.5|0.4879
70928256|NCT04909801|141352052|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.2||||0.2812|TWO_SIDED|95.0|-3.5|1.0|||longitudinal|||Day 113||1.0|-3.5|0.2812
70928257|NCT04909801|141352052|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.7||||0.1205|TWO_SIDED|95.0|-3.9|0.5|||longitudinal|||Day 141||0.5|-3.9|0.1205
70928258|NCT04909801|141352052|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.4||||0.3001|TWO_SIDED|95.0|-4.1|1.3|||longitudinal|||Day 169||1.3|-4.1|0.3001
70928259|NCT04909801|141352053|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|1.2||||0.4107|TWO_SIDED|95.0|-1.6|4.0|||longitudinal|||Day 29||4.0|-1.6|0.4107
70928260|NCT04909801|141352053|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.5||||0.6824|TWO_SIDED|95.0|-2.1|3.2|||longitudinal|||Day 57||3.2|-2.1|0.6824
70928261|NCT04909801|141352053|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-0.7||||0.5793|TWO_SIDED|95.0|-3.4|1.9|||longitudinal|||Day 85||1.9|-3.4|0.5793
70928262|NCT04909801|141352053|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.5||||0.2883|TWO_SIDED|95.0|-4.2|1.2|||longitudinal|||Day 113||1.2|-4.2|0.2883
70928263|NCT04909801|141352053|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.7||||0.1285|TWO_SIDED|95.0|-3.9|0.5|||longitudinal|||Day 141||0.5|-3.9|0.1285
70928264|NCT04909801|141352053|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.5||||0.2815|TWO_SIDED|95.0|-4.2|1.2|||longitudinal|||Day 169||1.2|-4.2|0.2815
70928265|NCT04909801|141352058|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.3||||0.0099|TWO_SIDED|95.0|0.1|0.5|||longitudinal|||Day 29||0.5|0.1|0.0099
70928266|NCT04909801|141352058|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.2||||0.1519|TWO_SIDED|95.0|-0.1|0.4|||longitudinal|||Day 57||0.4|-0.1|0.1519
70928267|NCT04909801|141352058|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.1||||0.2505|TWO_SIDED|95.0|-0.1|0.4|||longitudinal|||Day 85||0.4|-0.1|0.2505
70928268|NCT04909801|141352058|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-0.1||||0.5248|TWO_SIDED|95.0|-0.3|0.2|||longitudinal|||Day 113||0.2|-0.3|0.5248
70928269|NCT04909801|141352058|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.0||||0.1778|TWO_SIDED|95.0|-0.3|0.2|||longitudinal|||Day 141||0.2|-0.3|0.1778
70928270|NCT04909801|141352058|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.0||||0.851|TWO_SIDED|95.0|-0.3|0.2|||longitudinal|||Day 169||0.2|-0.3|0.8510
70928271|NCT04909801|141352059|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|1.3||||0.2319|TWO_SIDED|95.0|-0.9|3.5|||longitudinal|||Day 29||3.5|-0.9|0.2319
70928272|NCT04909801|141352059|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.6||||0.5572|TWO_SIDED|95.0|-1.5|2.7|||longitudinal|||Day 57||2.7|-1.5|0.5572
70928273|NCT04909801|141352059|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.1||||0.9366|TWO_SIDED|95.0|-2.0|2.1|||longitudinal|||Day 85||2.1|-2.0|0.9366
70928274|NCT04909801|141352059|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.2||||0.1508|TWO_SIDED|95.0|-3.5|1.0|||longitudinal|||Day 113||1.0|-3.5|0.1508
70928275|NCT04909801|141352059|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.9||||0.0303|TWO_SIDED|95.0|-3.6|-0.2|||longitudinal|||Day 141||-0.2|-3.6|0.0303
70928276|NCT04909801|141352059|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.2||||0.2333|TWO_SIDED|95.0|-3.3|0.8|||longitudinal|||Day 169||0.8|-3.3|0.2333
70928277|NCT04909801|141352060|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|1.9||||0.0938|TWO_SIDED|95.0|-0.3|4.2|||longitudinal|||Day 29||4.2|-0.3|0.0938
70928278|NCT04909801|141352060|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.6||||0.6053|TWO_SIDED|95.0|-1.6|2.7|||longitudinal|||Day 57||2.7|-1.6|0.6053
70928279|NCT04909801|141352060|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.2||||0.857|TWO_SIDED|95.0|-1.9|2.3|||longitudinal|||Day 85||2.3|-1.9|0.8570
70928280|NCT04909801|141352060|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.2||||0.1592|TWO_SIDED|95.0|-3.0|0.5|||longitudinal|||Day 113||0.5|-3.0|0.1592
70928281|NCT04909801|141352060|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.9||||0.0319|TWO_SIDED|95.0|-3.7|-0.2|||longitudinal|||Day 141||-0.2|-3.7|0.0319
70928282|NCT04909801|141352060|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.3||||0.2059|TWO_SIDED|95.0|-3.4|0.7|||longitudinal|||Day 169||0.7|-3.4|0.2059
70928283|NCT04117347|141352089|OTHER|Dose Response Relationship.|Coefficient for an indicator|0.022|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|95.0|-0.0861723|0.1309519|||||coefficient for an indicator for Light Therapy B (vs. Light Therapy A)|Analysis for left amygdala.||0.1309519|-0.0861723|
70928284|NCT04117347|141352089|OTHER|Dose Response Relationship.|Coefficient for an indicator|0.068|STANDARD_ERROR_OF_MEAN|0.052|||TWO_SIDED|95.0|-0.0363877|0.1730965|||||coefficient for an indicator for Light Therapy C (vs. Light Therapy A)|Analysis for left amygdala.||0.1730965|-0.0363877|
70928285|NCT04117347|141352089|OTHER|Dose Response Relationship.|Coefficient for an indicator|0.043|STANDARD_ERROR_OF_MEAN|0.055|||TWO_SIDED|95.0|-0.0676154|0.1545869|||||coefficient for an indicator for Light Therapy B (vs. Light Therapy A)|Analysis for right amygdala.||0.1545869|-0.0676154|
71103549|NCT00863304|141714824|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.57|-0.25||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.25|-0.57|<0.001
70928286|NCT04117347|141352089|OTHER|Dose Response Relationship.|Coefficient for an indicator|0.018|STANDARD_ERROR_OF_MEAN|0.053|||TWO_SIDED|95.0|-0.0888691|0.1255146|||||coefficient for an indicator for Light Therapy C (vs. Light Therapy A)|Analysis for right amygdala.||0.1255146|-0.0888691|
70928287|NCT03687086|141352090|SUPERIORITY||Odds Ratio (OR)|1.95|STANDARD_ERROR_OF_MEAN|0.63||0.039|TWO_SIDED|95.0|1.03|3.7|||Regression, Logistic|||||3.70|1.03|.039
70928288|NCT03687086|141352091|SUPERIORITY||Mean Difference (Net)|1.38|STANDARD_ERROR_OF_MEAN|0.97||0.155|TWO_SIDED|95.0|-0.52|3.29|||Mixed Models Analysis|Interaction contrast of Treatment Group (Program A vs. Program B) by Time (9 Weeks vs. baseline)||||3.29|-0.52|0.155
70928289|NCT03687086|141352092|SUPERIORITY||Median Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|1.04||0.88|TWO_SIDED|95.0|-1.88|2.2|||Mixed Models Analysis|Interaction contrast of Treatment Group (Program A vs. Program B) by Time (6 months vs. baseline)||||2.20|-1.88|0.880
70928290|NCT03687086|141352093|SUPERIORITY||Mean Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|0.39||0.228|TWO_SIDED|95.0|-1.25|0.3|||Mixed Models Analysis|Interaction contrast of Treatment Group (Program A vs. Program B) by Time (9 weeks vs. baseline)||||0.30|-1.25|0.228
70928291|NCT03687086|141352094|SUPERIORITY||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.44||0.843|TWO_SIDED|95.0|-0.96|0.78|||Mixed Models Analysis|Interaction contrast of Treatment Group (Program A vs. Program B) by Time (6 months vs. baseline)||||0.78|-0.96|0.843
70928292|NCT03687086|141352095|SUPERIORITY||Odds Ratio (OR)|3.68|STANDARD_ERROR_OF_MEAN|1.48||0.001|TWO_SIDED|95.0|1.67|8.12|||Regression, Logistic|||||8.12|1.67|0.001
70928293|NCT03687086|141352096|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.42||0.443|TWO_SIDED|95.0|-1.14|0.5|||Mixed Models Analysis|Interaction contrast of Treatment Group (Program A vs. Program B) by Time (9 weeks vs. baseline)||||0.50|-1.14|0.443
70928294|NCT03687086|141352097|SUPERIORITY||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.51||0.409|TWO_SIDED|95.0|-1.41|0.58|||Mixed Models Analysis|Interaction contrast of Treatment Group (Program A vs. Program B) by Time (6 months vs. baseline)||||0.58|-1.41|0.409
70928295|NCT02505984|141352106|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
70928296|NCT02505984|141352106|SUPERIORITY|||||||0.093|||||||Wilcoxon (Mann-Whitney)|||||||0.093
70928297|NCT02505984|141352106|SUPERIORITY|||||||0.077|||||||Wilcoxon (Mann-Whitney)|||||||0.077
70928298|NCT02505984|141352106|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
70928299|NCT02505984|141352107|SUPERIORITY||||||>|0.9|||||||Wilcoxon (Mann-Whitney)|||||||>0.9
70928300|NCT02505984|141352107|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
70928301|NCT02505984|141352108|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
70928302|NCT02505984|141352108|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
71103550|NCT00863304|141714824|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.48|-0.15||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.15|-0.48|<0.001
71103551|NCT00863304|141714824|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.051|TWO_SIDED|95.0|-0.33|0.0||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.00|-0.33|0.051
71103552|NCT00863304|141714824|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.08||0.003|TWO_SIDED|95.0|-0.41|-0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.08|-0.41|0.003
70928303|NCT02505984|141352109|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.7
70928304|NCT02505984|141352109|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
70928305|NCT02505984|141352109|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
70928306|NCT05194956|141352110|SUPERIORITY||Mean Difference (Net)|8.5||||0.0006|TWO_SIDED|95.0|3.75|13.15|||Two-period two-treatment crossover ANOVA|P-values are calculated taking sequence and period effects into account.|This estimation value assumes period and sequence effects are equal between the treatments.|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)||13.15|3.75|0.0006
70928307|NCT05194956|141352110|SUPERIORITY|Sequence effects||||||0.1984|||||||ANOVA|||||||0.1984
70928308|NCT05194956|141352110|SUPERIORITY|Period effects||||||0.7494|||||||ANOVA|||||||0.7494
70928309|NCT05194956|141352110|SUPERIORITY|Mixed effects modelling|Mean Difference (Net)|-13.31||||0.001|TWO_SIDED|95.0|-21.29|-5.33|||Mixed Models Analysis|||||-5.33|-21.29|0.001
71010067|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|1.3|STANDARD_ERROR_OF_MEAN|2.56|||TWO_SIDED|95.0|-4.02|6.63|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||6.63|-4.02|
71103553|NCT00863304|141714824|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.08||0.069|TWO_SIDED|95.0|-0.32|0.01||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.01|-0.32|0.069
70928310|NCT05194956|141352111|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|-3.4||||0.123|TWO_SIDED|95.0|-7.71|0.91||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||0.91|-7.71|0.1230
71010068|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|2.93|STANDARD_ERROR_OF_MEAN|2.5|||TWO_SIDED|95.0|-2.26|8.12|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||8.12|-2.26|
71010069|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|-1.34|STANDARD_ERROR_OF_MEAN|2.98|||TWO_SIDED|95.0|-7.52|4.85|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||4.85|-7.52|
70928311|NCT05194956|141352111|SUPERIORITY|Sequence effects||||||0.8423|||||||ANOVA|||||||0.8423
70928312|NCT05194956|141352111|SUPERIORITY|Period effects||||||0.9544|||||||ANOVA|||||||0.9544
70928313|NCT05194956|141352112|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|-3.4||||0.0439|TWO_SIDED|95.0|-6.69|-0.12||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||-0.12|-6.69|0.0439
71010070|NCT03091920|141526980|OTHER|No statistical testing was performed.|Least squares mean difference|-1.14|STANDARD_ERROR_OF_MEAN|2.94|||TWO_SIDED|95.0|-7.25|4.98|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||4.98|-7.25|
71010071|NCT03091920|141526981|OTHER|No statistical testing was performed.|Least squares mean difference|-0.288|STANDARD_ERROR_OF_MEAN|0.274|||TWO_SIDED|95.0|-0.857|0.282|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|||0.282|-0.857|
70928314|NCT05194956|141352112|SUPERIORITY|Sequence effects||||||0.3878|||||||ANOVA|||||||0.3878
70928315|NCT05194956|141352112|SUPERIORITY|Period effects||||||0.9772|||||||ANOVA|||||||0.9772
70928316|NCT05194956|141352113|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|9.6||||0.0213|TWO_SIDED|95.0|1.5|17.79||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||17.79|1.50|0.0213
70928317|NCT05194956|141352113|SUPERIORITY|Sequence effects||||||0.1583|||||||ANOVA|||||||0.1583
70928318|NCT05194956|141352113|SUPERIORITY|Period effects||||||0.4709|||||||ANOVA|||||||0.4709
70928319|NCT05194956|141352114|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|5.3||||0.0146|TWO_SIDED|95.0|1.09|9.46||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||9.46|1.09|0.0146
70928320|NCT05194956|141352114|SUPERIORITY|Sequence effects||||||0.5911|||||||ANOVA|||||||0.5911
70928321|NCT05194956|141352114|SUPERIORITY|Period effects||||||0.5825|||||||ANOVA|||||||0.5825
70928322|NCT05194956|141352115|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|-5.2||||0.0817|TWO_SIDED|95.0|-11.12|0.69||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||0.69|-11.12|0.0817
70928323|NCT05194956|141352115|SUPERIORITY|Sequence effects||||||0.091|||||||ANOVA|||||||0.0910
71103554|NCT00863304|141714824|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.57|-0.24||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.24|-0.57|<0.001
70928324|NCT05194956|141352115|SUPERIORITY|Period effects||||||0.2278|||||||ANOVA|||||||0.2278
70928325|NCT05194956|141352116|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|-2.2||||0.1347|TWO_SIDED|95.0|-5.17|0.69|||Two-period two-treatment crossover ANOVA|From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|This estimation value assumes period and sequence effects are equal between the treatments.|||0.69|-5.17|0.1347
70928326|NCT05194956|141352116|SUPERIORITY|Sequence effects||||||0.9259|||||||ANOVA|||||||0.9259
70928327|NCT05194956|141352116|SUPERIORITY|Period effects||||||0.8225|||||||ANOVA|||||||0.8225
70928328|NCT05194956|141352117|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Median Difference (Net)|-11.2||||0.02|TWO_SIDED|95.0|-20.47|-1.83||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||-1.83|-20.47|0.0200
70928329|NCT05194956|141352117|SUPERIORITY|Sequence effects||||||0.9104|||||||ANOVA|||||||0.9104
70928330|NCT05194956|141352117|SUPERIORITY|Period effects||||||0.5194|||||||ANOVA|||||||0.5194
71010072|NCT03091920|141526981|OTHER|No statistical testing was performed.|Least squares mean difference|-0.105|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|95.0|-0.708|0.498|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|||0.498|-0.708|
71010073|NCT03091920|141526981|OTHER|No statistical testing was performed.|Least squares mean difference|-0.196|STANDARD_ERROR_OF_MEAN|0.255|||TWO_SIDED|95.0|-0.727|0.335|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|||0.335|-0.727|
70928331|NCT05194956|141352118|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|-23.2|||<|5e-05|TWO_SIDED|95.0|-30.71|-15.75||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||-15.75|-30.71|<0.00005
70928332|NCT05194956|141352118|SUPERIORITY|Sequence effects||||||0.1369|||||||ANOVA|||||||0.1369
70928333|NCT05194956|141352118|SUPERIORITY|Period effects||||||0.3366|||||||ANOVA|||||||0.3366
71010074|NCT03091920|141526986|OTHER|No statistical testing was performed.|Least squares mean difference|-23.188|STANDARD_ERROR_OF_MEAN|27.97|||TWO_SIDED|95.0|-84.13|37.753|||||Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 8||37.753|-84.130|
71046298|NCT02508259|141600941|EQUIVALENCE|In this analysis, overall ASD symptom scores, measured by CGI were compared between suramin and placebo groups.|Mean Difference (Final Values)|-1.8|STANDARD_DEVIATION|1.04||0.05|TWO_SIDED|95.0|-3.4|-0.15|||ANOVA|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.||-0.15|-3.4|0.05
70928334|NCT05194956|141352119|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|-120.0|||<|5e-05|TWO_SIDED|95.0|-149.54|-90.38|||Two-period two-treatment crossover ANOVA|From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|This estimation value assumes period and sequence effects are equal between the treatments.|||-90.38|-149.54|<0.00005
70928335|NCT05194956|141352119|SUPERIORITY|Sequence effects||||||0.8509|||||||ANOVA|||||||0.8509
70928336|NCT05194956|141352119|SUPERIORITY|Period effects||||||0.0355|||||||ANOVA|||||||0.0355
70928337|NCT01922050|141352122|SUPERIORITY||Rate ratio|0.53|||<|0.001|TWO_SIDED|95.0|0.4|0.69|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||||0.69|0.40|<0.001
70928338|NCT01922050|141352122|SUPERIORITY||Rate ratio|0.46|||<|0.001|TWO_SIDED|95.0|0.35|0.61|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||||0.61|0.35|<0.001
70928339|NCT01922050|141352122|SUPERIORITY||Rate ratio|0.36|||<|0.001|TWO_SIDED|95.0|0.28|0.48|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||||0.48|0.28|<0.001
71010075|NCT03091920|141526986|OTHER|No statistical testing was performed.|Least squares mean difference|-14.033|STANDARD_ERROR_OF_MEAN|26.092|||TWO_SIDED|95.0|-70.883|42.817|||||Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 8||42.817|-70.883|
70928340|NCT01922050|141352122|SUPERIORITY||Rate ratio|0.88||||0.38|TWO_SIDED|95.0|0.66|1.17|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||||1.17|0.66|0.38
70928341|NCT01922050|141352122|SUPERIORITY||Rate ratio|0.69||||0.013|TWO_SIDED|95.0|0.52|0.93|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||||0.93|0.52|0.013
70928342|NCT01922050|141352122|SUPERIORITY||Rate ratio|0.79||||0.13|TWO_SIDED|95.0|0.58|1.07|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||||1.07|0.58|0.13
70928343|NCT01922050|141352123|SUPERIORITY||Ratio of clearance rates|0.74||||0.57|TWO_SIDED|95.0|0.27|2.04|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||2.04|0.27|0.57
70928344|NCT01922050|141352123|SUPERIORITY||Ratio of clearance rates|1.33||||0.51|TWO_SIDED|95.0|0.56|3.13|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||3.13|0.56|0.51
70928345|NCT01922050|141352123|SUPERIORITY||Ratio of clearance rates|1.9||||0.11|TWO_SIDED|95.0|0.86|4.21|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||4.21|0.86|0.11
70928346|NCT01922050|141352123|SUPERIORITY||Ratio of clearance rates|1.79||||0.21|TWO_SIDED|95.0|0.72|4.43|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||4.43|0.72|0.21
70928347|NCT01922050|141352123|SUPERIORITY||Ratio of clearance rates|2.55||||0.031|TWO_SIDED|95.0|1.09|5.98|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||5.98|1.09|0.031
70928348|NCT01922050|141352123|SUPERIORITY||Ratio of clearance rates|1.43||||0.29|TWO_SIDED|95.0|0.74|2.75|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||2.75|0.74|0.29
70928349|NCT01922050|141352124|SUPERIORITY||Ratio of clearance rates|1.69||||0.026|TWO_SIDED|95.0|1.06|2.69|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||2.69|1.06|0.026
70928350|NCT01922050|141352124|SUPERIORITY||Ratio of clearance rates|1.79||||0.013|TWO_SIDED|95.0|1.13|2.84|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||2.84|1.13|0.013
70928351|NCT01922050|141352124|SUPERIORITY||Ratio of clearance rates|2.1|||<|0.001|TWO_SIDED|95.0|1.35|3.25|||Log binomial regression|||||3.25|1.35|<0.001
71046299|NCT02508259|141600942|EQUIVALENCE|In this analysis, the child-specific RBQ score was tested for equivalence before and 6-weeks after suramin treatment.|Mean Difference (Net)|-3.2|STANDARD_DEVIATION|5.8||0.28|TWO_SIDED|95.0|-10.4|4.0|||t-test, 2 sided|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.||4.0|-10.4|0.28
70928352|NCT01922050|141352124|SUPERIORITY||Ratio of clearance rates|1.06||||0.73|TWO_SIDED|95.0|0.76|1.47|||Log binomial regression|||||1.47|0.76|0.73
71046300|NCT05626803|141600957|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
70928353|NCT01922050|141352124|SUPERIORITY||Ratio of clearance rates|1.24||||0.16|TWO_SIDED|95.0|0.92|1.67|||Log binomial regression|||||1.67|0.92|0.16
70928354|NCT01922050|141352124|SUPERIORITY||Ratio of clearance rates|1.17||||0.3|TWO_SIDED|95.0|0.87|1.57|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||1.57|0.87|0.30
70928355|NCT05192109|141352143|OTHER||||||<|0.01||||||This is the p-value for the simple effect of condition.|Regression, Linear|||The primary statistical analysis involves asking whether children's preference to look at the target is significantly greater in one condition and/or group than the other. Mixed-effects regression analyses are used with the proportion-empirical-logit transformed-of target looking as the dependent measure, participant as random effect, and condition and group and their interaction as fixed effects.||||<0.01
70928356|NCT05192109|141352143|OTHER|||||||0.93||||||This is the p-value for the simple effect of diagnostic group.|Regression, Linear|||The primary statistical analysis involves asking whether children's preference to look at the target is significantly greater in one condition and/or group than the other. Mixed-effects regression analyses are used with the proportion-empirical-logit transformed-of target looking as the dependent measure, participant as random effect, and condition and group and their interaction as fixed effects.||||0.93
71046301|NCT05626803|141600957|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
70928357|NCT05192109|141352143|OTHER||||||<|0.01||||||This is the p-value for the interaction between condition and group.|Regression, Linear|||The primary statistical analysis involves asking whether children's preference to look at the target is significantly greater in one condition and/or group than the other. Mixed-effects regression analyses are used with the proportion-empirical-logit transformed-of target looking as the dependent measure, participant as random effect, and condition and group and their interaction as fixed effects.||||<0.01
70928358|NCT05192109|141352144|OTHER||||||<|0.01||||||This is the p-value for the simple effect of condition.|Regression, Linear|||The primary statistical analysis involves asking whether children's preference to look at the target is significantly greater in one condition and/or group than the other. Mixed-effects regression analyses are used with the proportion-empirical-logit transformed-of target looking as the dependent measure, participant as random effect, and condition and group and their interaction as fixed effects.||||<0.01
70928359|NCT05192109|141352144|OTHER|||||||0.22||||||This is the p-value for the simple effect of group.|Regression, Linear|||The primary statistical analysis involves asking whether children's preference to look at the target is significantly greater in one condition and/or group than the other. Mixed-effects regression analyses are used with the proportion-empirical-logit transformed-of target looking as the dependent measure, participant as random effect, and condition and group and their interaction as fixed effects.||||0.22
70928360|NCT05192109|141352144|OTHER||||||<|0.01||||||This is the p-value for the interaction between condition and group.|Regression, Linear|||The primary statistical analysis involves asking whether children's preference to look at the target is significantly greater in one condition and/or group than the other. Mixed-effects regression analyses are used with the proportion-empirical-logit transformed-of target looking as the dependent measure, participant as random effect, and condition and group and their interaction as fixed effects.||||<0.01
70928361|NCT02709161|141352160|SUPERIORITY||Mean Difference (Final Values)|8.2|||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
70928362|NCT02709161|141352161|SUPERIORITY||Mean Difference (Final Values)|8.2|||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
71046302|NCT05626803|141600957|SUPERIORITY|||||||0.0003|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||0.0003
71046303|NCT05626803|141600959|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
71046304|NCT05626803|141600959|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
71046305|NCT05626803|141600959|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
71046306|NCT05626803|141600961|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
71046307|NCT05626803|141600961|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
71046308|NCT05626803|141600961|SUPERIORITY|||||||0.0017|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||0.0017
71046309|NCT05626803|141600963|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
70928363|NCT05671653|141352222|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|88.85|||||TWO_SIDED|90.0|80.25|98.38||||||Reference: Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1). Test: Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4).||98.38|80.25|
70928364|NCT05671653|141352222|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|70.0|||||TWO_SIDED|90.0|55.21|88.76||||||Reference: Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1). Test: Cohort 1: PF-07081532 260 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 7).||88.76|55.21|
70928365|NCT05671653|141352223|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|57.19|||||TWO_SIDED|90.0|39.27|83.29||||||Reference: Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1). Test: Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4).||83.29|39.27|
70928366|NCT05671653|141352223|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|29.68|||||TWO_SIDED|90.0|19.6|44.94||||||Reference: Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1). Test: Cohort 1: PF-07081532 260 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 7).||44.94|19.60|
71046310|NCT05626803|141600963|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
71046311|NCT05626803|141600963|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
71046312|NCT05626803|141600965|SUPERIORITY|||||||0.0059|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||0.0059
70941337|NCT00676663|141383237|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.018|TWO_SIDED|95.0|0.36|0.97||P-value is stratified by the randomization stratification factors and is 1-sided.|Log Rank||Hazard ratio was estimated from a Cox proportional hazards model. Placebo serves as the reference treatment group for the interpretation of the hazard ratio.|||0.97|0.36|0.018
71046313|NCT05626803|141600965|SUPERIORITY|||||||0.002|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||0.0020
71046314|NCT05626803|141600965|SUPERIORITY|||||||0.1899|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||0.1899
71046315|NCT05626803|141600967|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
71046316|NCT05626803|141600967|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
71046317|NCT05626803|141600967|SUPERIORITY|||||||0.002|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||0.0020
71046318|NCT02054130|141601000|SUPERIORITY||Rate ratio|0.38|||<|0.001|TWO_SIDED|95.0|0.23|0.63|||Negative binomial regression|||||0.63|0.23|<0.001
71046319|NCT02054130|141601000|SUPERIORITY||Rate ratio|0.29|||<|0.001|TWO_SIDED|95.0|0.16|0.51|||Negative binomial regression|||||0.51|0.16|<0.001
71046320|NCT02054130|141601000|SUPERIORITY||Rate ratio|0.34|||<|0.001|TWO_SIDED|95.0|0.2|0.58|||Negative bnomial regression|||||0.58|0.20|<0.001
71046321|NCT00094458|141601022|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline||||||<0.001
71046322|NCT00094458|141601022|SUPERIORITY_OR_OTHER|||||||0.006|||||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline||||||0.006
70928367|NCT05671653|141352224|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|119.86|||||TWO_SIDED|90.0|108.97|131.85||||||Reference: Cohort 1: LE 0.15 mg \& EE 0.03 mg (Period 2). Test: Cohort 1: PF-07081532 80 mg QD + LE 0.15 mg \& EE 0.03 mg (Period 5).||131.85|108.97|
70928368|NCT05671653|141352224|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|185.45|||||TWO_SIDED|90.0|108.0|318.44||||||Reference: Cohort 1: LE 0.15 mg \& EE 0.03 mg (Period 2). Test: Cohort 1: PF-07081532 260 mg QD + LE 0.15 mg \& EE 0.03 mg (Period 8)||318.44|108.00|
71046323|NCT00094458|141601022|SUPERIORITY_OR_OTHER|||||||0.022|||||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline||||||0.022
71046324|NCT00094458|141601023|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline||||||<0.001
71046325|NCT00094458|141601023|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline||||||0.023
71046326|NCT00094458|141601023|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline||||||0.055
71046327|NCT00834652|141601031|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71103555|NCT00863304|141714824|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.53|-0.2||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.20|-0.53|<0.001
71103556|NCT00863304|141714824|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.08||0.012|TWO_SIDED|95.0|-0.37|-0.05||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.05|-0.37|0.012
70928369|NCT05671653|141352225|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|103.17|||||TWO_SIDED|90.0|95.09|111.93||||||Reference: Cohort 1: LE 0.15 mg \& EE 0.03 mg (Period 2). Test: Cohort 1: PF-07081532 80 mg QD + LE 0.15 mg \& EE 0.03 mg (Period 5).||111.93|95.09|
71046328|NCT01490931|141601056|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P value adjusted with Bonferroni corrections for multiple comparisons|t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
71046329|NCT01490931|141601060|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
71046330|NCT01490931|141601061|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
71046331|NCT01490931|141601062|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
71046332|NCT01490931|141601063|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
71046333|NCT01490931|141601064|SUPERIORITY_OR_OTHER||||||<|1|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0001
71046334|NCT01490931|141601065|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
71103557|NCT00863304|141714824|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.02|TWO_SIDED|95.0|-0.36|-0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.03|-0.36|0.020
71103558|NCT00863304|141714824|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.064|TWO_SIDED|95.0|-0.32|0.01||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.01|-0.32|0.064
70928370|NCT05671653|141352225|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|90.2|||||TWO_SIDED|90.0|60.24|135.06||||||Reference: Cohort 1: LE 0.15 mg \& EE 0.03 mg (Period 2). Test: Cohort 1: PF-07081532 260 mg QD + LE 0.15 mg \& EE 0.03 mg (Period 8)||135.06|60.24|
70928371|NCT05671653|141352226|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|92.88|||||TWO_SIDED|90.0|79.97|107.87||||||Reference: Cohort 2: Midazolam 2 mg (Period 1). Test: Cohort 2: Semaglutide 2.4 mg QW + Midazolam 2 mg (Period 3).||107.87|79.97|
70928372|NCT03974178|141352270|OTHER|"The minimal sample size to get a possible rejection of H0 (pdeath = 8.5% or more) in favour of H1 (pdeath \<8.5%) was 34 evaluable patients with stage 2 r-HAT.~The hypothesis was tested with a one-sided exact test for proportions at the 0.05 significance level."|Fatality rate|0.0||||0.0488|TWO_SIDED|90.0|0.0|8.43||The rate of deaths possibly related to r-HAT or to fexinidazole at the end of hospitalization was compared to the predefined unacceptable rate of 8.5%.|one-sided exact test|Clopper Pearson exact method||"The proportion of deaths (pdeath) is compared to the threshold of 8.5%, with H0 being pdeath = 8.5% or more.~The 90% confidence interval of the fatality rate is calculated with the Clopper-Pearson method."||8.43|0|0.0488
71046335|NCT01490931|141601066|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
71046336|NCT01490931|141601067|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
71046337|NCT00518882|141601132|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority concluded if upper confidence interval of test is below 0.4%|Estimated treatment difference, LS Mean|-0.33|||<|0.0001||95.0|-0.47|-0.18||No multiplicity concerns|ANCOVA|||"ANCOVA with treatment, country and previous OAD treatment as fixed effects and baseline HbA1c as covariate.~2 hypotheses were tested: H01: µliraglutide ≥ µexenatide + Δ, HA1: µliraglutide \< µexenatide + Δ; Δ=0.4%. If non-inferiority was concluded, a test for superiority was established by a 1-sided test of the hypothesis H02: µliraglutide ≥ µexenatide against HA2: µliraglutide \< µexenatide. Superiority was concluded if the upper limit of the 2-sided 95% CI for the difference was below 0%."||-0.18|-0.47|<.0001
71046338|NCT00518882|141601133|SUPERIORITY_OR_OTHER||Mean|0.25|STANDARD_DEVIATION|0.803|<|0.0001||95.0|0.139|0.364|||Paired t-test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.364|0.139|<0.0001
71046339|NCT00518882|141601133|SUPERIORITY_OR_OTHER||Mean|0.0|STANDARD_DEVIATION|0.924||0.9872||95.0|-1.36|0.134|||Paired t-test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.134|-1.36|0.9872
71046340|NCT00518882|141601134|SUPERIORITY_OR_OTHER||Mean|-0.98|STANDARD_DEVIATION|1.119|<|0.0001||95.0|-1.137|-0.823|||Paired t-test|||The analysis was made with a paired t test within the treatment group and 95% confidence intervals for the difference between Weeks 0 and 78 were constructed. H0 was µ78 - µ0 = 0 against HA: µ78 - µ0 ≠ 0. A difference between the two means (Weeks 0 and 78) was concluded when H0 was rejected at the 5% level.||-0.823|-1.137|<0.0001
71103559|NCT02507934|141714866|SUPERIORITY||Mean Difference (Final Values)|8.56||||0.0129|TWO_SIDED|95.0|2.41|14.72||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Foreign body sensation - Left eye||14.72|2.41|0.0129
71046341|NCT00518882|141601134|SUPERIORITY_OR_OTHER||Mean|-0.85|STANDARD_DEVIATION|1.105|<|0.0001||95.0|-1.01|-0.687|||Paired t-test|||The analysis was made with a paired t test within the exenatide→liraglutide group and 95% confidence intervals for the difference between Weeks 0 and 78 were constructed. H0 was µ78 - µ0 = 0 against HA: µ78 - µ0 ≠ 0. A difference between the two means (Weeks 0 and 78) was concluded when H0 was rejected at the 5% level.||-0.687|-1.010|<0.0001
71046342|NCT00518882|141601137|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.38||||0.2235||95.0|-0.99|0.23||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline body weight as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the body weight in the liraglutide arm and exenatide arm, respectively.||0.23|-0.99|0.2235
71103560|NCT02507934|141714866|SUPERIORITY||Mean Difference (Final Values)|7.58||||0.0077|TWO_SIDED|95.0|1.7|13.45||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Foreign body sensation - Right eye||13.45|1.70|0.0077
71103561|NCT02507934|141714866|SUPERIORITY||Mean Difference (Final Values)|3.99||||0.1589|TWO_SIDED|95.0|-1.64|9.62||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Burning/ Stinging - Left eye||9.62|-1.64|0.1589
71046343|NCT00518882|141601138|SUPERIORITY_OR_OTHER||Mean|-0.4|STANDARD_DEVIATION|3.24||0.0793||95.0|-0.86|0.05|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26=0 against HA: µ78 - µ26 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.05|-0.86|0.0793
70928373|NCT03974178|141352271|OTHER|The hypothesis H0 (pfailure at the end of hospitalization = 9% or more) was tested with a one-sided exact test for proportions at the 0.05 significance level.|Failure rate|0.0||||0.0405|TWO_SIDED|90.0|0.0|8.43||The rate of failures at the end of hospitalization was compared to the predefined unacceptable rate of 9%.|one-sided exact test|Clopper Pearson exact method||"The proportion of failures at the end of hospitalization (pfailure) is compared to the threshold of 9%, with H0 being pfailure = 9% or more.~The 90% confidence interval of the failure rate is calculated with the Clopper-Pearson method."||8.43|0|0.0405
70928374|NCT03974178|141352272|OTHER|The hypothesis H0 (pfailure at 12 months = 12% or more) was tested with a one-sided exact test for proportions at the 0.05 significance level.|Failure rate|2.94||||0.073|TWO_SIDED|90.0|0.15|13.21||The rate of failures at 12 months was compared to the predefined unacceptable rate of 12%.|one-sided exact test|Clopper Pearson exact method||"The proportion of failures at 12 months (pfailure) is compared to the threshold of 12%, with H0 being pfailure = 12% or more.~The 90% confidence interval of the failure rate is calculated with the Clopper-Pearson method."||13.21|0.15|0.0730
70928375|NCT03974178|141352275|OTHER|The hypothesis H0 (pdeath = 8.5% or more) was tested with a one-sided exact test for proportions at the 0.05 significance level.|Fatality rate|0.0||||0.0201|TWO_SIDED|90.0|0.0|6.58||The rate of deaths possibly related to r-HAT or to fexinidazole at the end of hospitalization was compared to the predefined unacceptable rate of 8.5%.|one-sided exact test|Clopper Pearson exact method||"The proportion of deaths (pdeath) is compared to the threshold of 8.5%, with H0 being pdeath = 8.5% or more.~The 90% confidence interval of the fatality rate is calculated with the Clopper-Pearson method."||6.58|0|0.0201
70928376|NCT03974178|141352276|OTHER|The hypothesis H0 (pfailure at the end of hospitalization = 9% or more) was tested with a one-sided exact test for proportions at the 0.05 significance level.|Failure rate|0.0||||0.0158|TWO_SIDED|90.0|0.0|6.58||The rate of failures at the end of hospitalization was compared to the predefined unacceptable rate of 9%.|one-sided exact test|Clopper Pearson exact method||"The proportion of failures at the end of hospitalization (pfailure) is compared to the threshold of 9%, with H0 being pfailure = 9% or more.~The 90% confidence interval of the failure rate is calculated with the Clopper-Pearson method."||6.58|0|0.0158
70928377|NCT03974178|141352277|OTHER|The hypothesis H0 (pfailure at 12 months = 12% or more) was tested with a one-sided exact test for proportions at the 0.05 significance level.|Failure rate|2.27||||0.0253|TWO_SIDED|90.0|0.12|10.34||The rate of failures at 12 months was compared to the predefined unacceptable rate of 12%.|one-sided exact test|Clopper Pearson exact method||"The proportion of failures at 12 months (pfailure) is compared to the threshold of 12%, with H0 being pfailure = 12% or more.~The 90% confidence interval of the failure rate is calculated with the Clopper-Pearson method."||10.34|0.12|0.0253
70928378|NCT04508309|141352303|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower bound of the 98.3% confidence interval of the geometric mean concentration (GMC) ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.09|||||TWO_SIDED|98.3|0.891|1.327|||||GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|The primary objective included three non-inferiority comparisons of Cecolin at 0 and 6 months, 0 and 12 months, or 0 and 24 months compared to Gardasil at 0 and 6 months. To control the type I error for the three co-primary non-inferiority hypotheses, a Bonferroni correction corresponding to 98.3% confidence intervals (CI) was used.||1.327|0.891|
70928379|NCT04508309|141352303|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower bound of the 98.3% confidence interval of the GMC ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.78|||||TWO_SIDED|98.3|1.455|2.176|||||GMC ratio (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|The primary objective included three non-inferiority comparisons of Cecolin at 0 and 6 months, 0 and 12 months, or 0 and 24 months compared to Gardasil at 0 and 6 months. To control the type I error for the three co-primary non-inferiority hypotheses, a Bonferroni correction corresponding to 98.3% CI was used.||2.176|1.455|
70928380|NCT04508309|141352303|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower bound of the 98.3% confidence interval of the geometric mean concentration (GMC) ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|2.37|||||TWO_SIDED|98.3|1.942|2.903|||||GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|The primary objective included three non-inferiority comparisons of Cecolin at 0 and 6 months, 0 and 12 months, or 0 and 24 months compared to Gardasil at 0 and 6 months. To control the type I error for the three co-primary non-inferiority hypotheses, a Bonferroni correction corresponding to 98.3% confidence intervals (CI) was used.||2.903|1.942|
70928381|NCT04508309|141352304|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower bound of the 98.3% confidence interval of the geometric mean concentration (GMC) ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.25|||||TWO_SIDED|98.3|1.022|1.539|||||GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|The primary objective included three non-inferiority comparisons of Cecolin at 0 and 6 months, 0 and 12 months, or 0 and 24 months compared to Gardasil at 0 and 6 months. To control the type I error for the three co-primary non-inferiority hypotheses, a Bonferroni correction corresponding to 98.3% confidence intervals (CI) was used.||1.539|1.022|
70941338|NCT00580047|141383239|OTHER||||||||||||||||||The intervention groups were compared for compliance to either having annual IV zoledronic acid, taking weekly oral alendronate, and taking calcium/vitamin D supplementation.|||
70941339|NCT00546884|141383245|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.16|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
70928382|NCT04508309|141352304|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower bound of the 98.3% confidence interval of the geometric mean concentration (GMC) ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.68|||||TWO_SIDED|98.3|1.372|2.069|||||GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|The primary objective included three non-inferiority comparisons of Cecolin at 0 and 6 months, 0 and 12 months, or 0 and 24 months compared to Gardasil at 0 and 6 months. To control the type I error for the three co-primary non-inferiority hypotheses, a Bonferroni correction corresponding to 98.3% confidence intervals (CI) was used.||2.069|1.372|
70928383|NCT04508309|141352304|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower bound of the 98.3% confidence interval of the geometric mean concentration (GMC) ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.71|||||TWO_SIDED|98.3|1.389|2.102|||||GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|The primary objective included three non-inferiority comparisons of Cecolin at 0 and 6 months, 0 and 12 months, or 0 and 24 months compared to Gardasil at 0 and 6 months. To control the type I error for the three co-primary non-inferiority hypotheses, a Bonferroni correction corresponding to 98.3% confidence intervals (CI) was used.||2.102|1.389|
71046344|NCT00518882|141601138|SUPERIORITY_OR_OTHER||Mean|-0.7|STANDARD_DEVIATION|3.67||0.0075||95.0|-1.26|-0.2|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||-0.20|-1.26|0.0075
71046345|NCT00518882|141601139|SUPERIORITY_OR_OTHER||Mean|-3.3|STANDARD_DEVIATION|4.63|<|0.0001||95.0|-3.9|-2.61|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-2.61|-3.90|<0.0001
71046346|NCT00518882|141601139|SUPERIORITY_OR_OTHER||Mean|-3.2|STANDARD_DEVIATION|4.44|<|0.0001||95.0|-3.85|-2.55|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-2.55|-3.85|<0.0001
71046347|NCT00518882|141601140|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-1.01|||<|0.0001||95.0|-1.37|-0.65||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline fasting plasma glucose as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the fasting plasma glucose in the liraglutide and exenatide arm, respectively.||-0.65|-1.37|<0.0001
71046348|NCT00518882|141601141|SUPERIORITY_OR_OTHER||Mean|0.7|STANDARD_DEVIATION|1.84|<|0.0001||95.0|0.48|1.0|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 26 and 78 were constructed. H0 was µ78- µ26=0 against HA: µ78 - µ26 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||1.00|0.48|<0.0001
71046349|NCT00518882|141601141|SUPERIORITY_OR_OTHER||Mean|-0.1|STANDARD_DEVIATION|2.42||0.4864||95.0|-0.48|0.23|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.23|-0.48|0.4864
71046350|NCT00518882|141601142|SUPERIORITY_OR_OTHER||Mean|-1.3|STANDARD_DEVIATION|2.5|<|0.0001||95.0|-1.62|-0.92|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78 - µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.92|-1.62|<0.0001
70941340|NCT04382053|141383246|SUPERIORITY||Least squares mean difference|0.11|STANDARD_ERROR_OF_MEAN|1.297||0.467|TWO_SIDED|90.0|-2.0|2.3|||ANCOVA|||||2.3|-2.0|0.467
71046351|NCT00518882|141601142|SUPERIORITY_OR_OTHER||Mean|-0.8|STANDARD_DEVIATION|2.76|<|0.0001||95.0|-1.23|-0.42|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78 - µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.42|-1.23|<0.0001
71046352|NCT00518882|141601143|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|1.33|||<|0.0001||95.0|0.8|1.86||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||1.86|0.80|<.0001
71046353|NCT00518882|141601144|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.01||||0.9849||95.0|-0.52|0.53||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||0.53|-0.52|0.9849
71046354|NCT00518882|141601145|SUPERIORITY_OR_OTHER||LS Mean|1.01||||0.0005||95.0|0.44|1.57||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||1.57|0.44|0.0005
70928384|NCT04508309|141352309|NON_INFERIORITY|Non-inferiority of the Cecolin containing arm (Group 5) compared to Gardasil at months 0 and 6 (Group 4) was to be demonstrated if the lower limit of the 95% CI of the GMC ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.75|||||TWO_SIDED|95.0|1.476|2.071|||||GMC ratio (Cecolin containing arm (Group 5)/Gardasil (Group 4)) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|||2.071|1.476|
70928385|NCT04508309|141352310|NON_INFERIORITY|Non-inferiority of the Cecolin containing arm (Group 5) compared to Gardasil at months 0 and 6 (Group 4) was to be demonstrated if the lower limit of the 95% CI of the GMC ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.21|||||TWO_SIDED|95.0|1.004|1.451|||||GMC ratio (Cecolin containing arm (Group 5)/Gardasil (Group 4)) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|||1.451|1.004|
71010076|NCT03091920|141526986|OTHER|No statistical testing was performed.|Least squares mean difference|-18.611|STANDARD_ERROR_OF_MEAN|24.138|||TWO_SIDED|95.0|-71.204|33.982|||||Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 8||33.982|-71.204|
71010077|NCT03091920|141526986|OTHER|No statistical testing was performed.|Least squares mean difference|-25.389|STANDARD_ERROR_OF_MEAN|16.885|||TWO_SIDED|95.0|-62.551|11.774|||||Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 15||11.774|-62.551|
71010078|NCT03091920|141526986|OTHER|No statistical testing was performed.|Least squares mean difference|-21.176|STANDARD_ERROR_OF_MEAN|16.221|||TWO_SIDED|95.0|-56.879|14.527|||||Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 15||14.527|-56.879|
71010079|NCT03091920|141526986|OTHER|No statistical testing was performed.|Least squares mean difference|-23.282|STANDARD_ERROR_OF_MEAN|14.691|||TWO_SIDED|95.0|-55.618|9.053|||||Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 15||9.053|-55.618|
71010080|NCT00453349|141527006|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was set to 15% in the protocol. Sample size was estimated using the method as described in Farrington-Manning (STATISTICS IN MEDICINE, Vol. 9; Farrington CP, Manning G: Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference..., pg.1447-1454 \[1990\]). Estimation was performed to achieve 90% power, based on the equivalence delta of 15%, and a clinical success rate of 87% in the per protocol population"|Mean Difference (Final Values)|-3.2||||||95.0|-10.7|4.9|||||Mean difference denotes the difference of clinical cure rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||4.9|-10.7|
71046355|NCT00518882|141601146|SUPERIORITY_OR_OTHER||Mean|-0.22|STANDARD_DEVIATION|2.866||0.2972||95.0|-0.626|0.192|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.192|-0.626|0.2972
71046356|NCT00518882|141601146|SUPERIORITY_OR_OTHER||Mean|1.15|STANDARD_DEVIATION|3.253|<|0.0001||95.0|0.66|1.637|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||1.637|0.660|<0.0001
71046357|NCT00518882|141601147|SUPERIORITY_OR_OTHER||Mean|0.05|STANDARD_DEVIATION|3.307||0.8396||95.0|-0.424|0.521|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.521|-0.424|0.8396
71046358|NCT00518882|141601147|SUPERIORITY_OR_OTHER||Mean|-0.09|STANDARD_DEVIATION|3.419||0.7278||95.0|-0.604|0.423|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.423|-0.604|0.7278
70941341|NCT04382053|141383247|SUPERIORITY|||||||0.237||||||One-sided|Mixed Models Analysis|p-value reported is for the treatment factor across all time points||||||0.237
71046359|NCT00518882|141601148|SUPERIORITY_OR_OTHER||Mean|0.22|STANDARD_DEVIATION|3.053||0.3271||95.0|-0.219|0.654|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.654|-0.219|0.3271
71046360|NCT00518882|141601148|SUPERIORITY_OR_OTHER||Mean|1.07|STANDARD_DEVIATION|3.775||0.0003||95.0|0.497|1.634|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||1.634|0.497|0.0003
70928386|NCT04508309|141352311|NON_INFERIORITY|Non-inferiority of Cecolin at Months 0 and 6 (Group 1) compared to Gardasil at Months 0 and 6 (Group 4) was to be demonstrated if the lower limit of the 95% CI of the GMC ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.12|||||TWO_SIDED|95.0|0.933|1.344|||||GMC ratio (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|||1.344|0.933|
70928387|NCT04508309|141352312|NON_INFERIORITY|Non-inferiority of Cecolin at Months 0 and 6 (Group 1) compared to Gardasil at Months 0 and 6 (Group 4) was to be demonstrated if the lower limit of the 95% CI of the GMC ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.32|||||TWO_SIDED|95.0|1.07|1.635|||||GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|||1.635|1.070|
70928388|NCT03952338|141352379|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.97|TWO_SIDED|95.0|-4.07|3.93|||Mixed Models Analysis|||||3.93|-4.07|0.97
71010081|NCT00453349|141527007|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-1.9||||||95.0|-9.9|6.0|||||Mean difference denotes the difference of clinical cure rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||6.0|-9.9|
71010082|NCT00453349|141527008|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-3.2||||||95.0|-7.4|0.8|||||Mean difference denotes the difference of clinical improvement rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||0.8|-7.4|
71010083|NCT00453349|141527009|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-0.1||||||95.0|-8.1|7.5|||||Mean difference denotes the difference of clinical improvement rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||7.5|-8.1|
71010084|NCT00453349|141527010|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|5.4||||||95.0|-12.7|20.3|||||Mean difference denotes the difference of eradication rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||20.3|-12.7|
71010085|NCT00453349|141527011|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|4.3||||||95.0|-19.4|17.6|||||Mean difference denotes the difference of eradication rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||17.6|-19.4|
71010086|NCT00453349|141527012|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-2.5||||||95.0|-8.6|4.9|||||Mean difference denotes the difference of clinical cure rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||4.9|-8.6|
71046361|NCT00518882|141601149|SUPERIORITY_OR_OTHER||Mean|-1.08|STANDARD_DEVIATION|3.662|<|0.0001||95.0|-1.605|-0.562|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.562|-1.605|<0.0001
71046362|NCT00518882|141601149|SUPERIORITY_OR_OTHER||Mean|-0.99|STANDARD_DEVIATION|3.467||0.0003||95.0|-1.517|-0.458|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.458|-1.517|0.0003
70928389|NCT03952338|141352380|SUPERIORITY||Mean Difference (Final Values)|1.22||||0.57|TWO_SIDED|95.0|-3.0|5.44|||Mixed Models Analysis|||||5.44|-3.00|0.57
70928390|NCT03952338|141352381|SUPERIORITY||Mean Difference (Final Values)|1.96||||0.09|TWO_SIDED|95.0|-0.32|4.23|||Mixed Models Analysis|||||4.23|-0.32|0.09
70928391|NCT03952338|141352382|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.08|TWO_SIDED|95.0|-0.22|4.43|||Mixed Models Analysis|||||4.43|-0.22|0.08
70928392|NCT03952338|141352383|SUPERIORITY||Mean Difference (Final Values)|1.15||||0.09|TWO_SIDED|95.0|-0.17|2.46|||Mixed Models Analysis|||||2.46|-0.17|0.09
70928393|NCT03952338|141352384|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.95|TWO_SIDED|95.0|-1.39|1.3|||Mixed Models Analysis|||||1.30|-1.39|0.95
71010087|NCT00453349|141527013|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-0.1||||||95.0|-8.1|7.5|||||Mean difference denotes the difference of clinical cure rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||7.5|-8.1|
71010088|NCT00453349|141527014|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-7.9||||||95.0|-24.9|15.9|||||Mean difference denotes the difference of eradication rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||15.9|-24.9|
71010089|NCT00453349|141527015|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|3.7||||||95.0|-30.5|11.9|||||Mean difference denotes the difference of eradication rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||11.9|-30.5|
71010090|NCT00434876|141527061|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||Mixed Models Analysis|||||||0.49
71010091|NCT00434876|141527062|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Mixed Models Analysis|||||||0.04
71010092|NCT00434876|141527063|SUPERIORITY_OR_OTHER|||||||0.57||95.0|||||Mixed Models Analysis|||||||0.57
71010093|NCT00434876|141527064|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Mixed Models Analysis|||||||0.03
71010094|NCT01078389|141527069|SUPERIORITY_OR_OTHER|||||||0.472|||||||Ranked Analysis of Covariance (ANCOVA)|Baseline modified Sharp/van der Heijde Erosion Score as a covariate.||Change from Baseline at Month 24||||0.472
71010095|NCT01078389|141527070|SUPERIORITY_OR_OTHER|||||||0.548|||||||Ranked ANCOVA|Baseline modified Sharp/van der Heijde Total Score from full hands and feet as a covariate.||Change from Baseline at Month 24||||0.548
71010096|NCT01078389|141527071|SUPERIORITY_OR_OTHER|||||||0.389|||||||Ranked ANCOVA|Baseline modified Sharp/van der Heijde Erosion Score from full hands and feet as a covariate.||Change from Baseline at Month 24||||0.389
71010097|NCT01078389|141527072|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|Baseline RAMRIS Synovitis Score as a covariate.||Synovitis: Change from Baseline at Month 24||||<0.001
70928394|NCT03952338|141352385|SUPERIORITY||Odds Ratio (OR)|0.21||||0.01|TWO_SIDED|95.0|0.06|0.7|||Regression, Logistic|||||0.70|0.06|0.01
70928395|NCT03952338|141352386|SUPERIORITY||Odds Ratio (OR)|0.29||||0.04|TWO_SIDED|95.0|0.09|0.96|||Regression, Logistic|||||0.96|0.09|0.04
70928396|NCT03952338|141352387|SUPERIORITY||Odds Ratio (OR)|2.11||||0.236|TWO_SIDED|95.0|0.27|7.23|||Regression, Logistic|||||7.23|0.27|0.236
70928397|NCT03952338|141352388|SUPERIORITY||Odds Ratio (OR)|2.22||||0.22|TWO_SIDED|95.0|0.62|7.97|||Regression, Logistic|||||7.97|0.62|0.220
71010098|NCT01078389|141527072|SUPERIORITY_OR_OTHER|||||||0.634|||||||Ranked ANCOVA|Baseline RAMRIS Erosion(Distal+Proximal) Score as a covariate.||Erosion(Distal+Proximal): Change from Baseline at Month 24||||0.634
71010099|NCT01078389|141527072|SUPERIORITY_OR_OTHER|||||||0.307|||||||Ranked ANCOVA|Baseline RAMRIS Edema(Distal+Proximal) Score as a covariate.||Edema(Distal+Proximal): Change from Baseline at Month 24||||0.307
71010100|NCT01078389|141527073|SUPERIORITY_OR_OTHER|||||||0.122|||||||Ranked ANCOVA|Baseline modified Sharp/van der Heijde Total Score as a covariate.||Change from Baseline at Month 24||||0.122
71010101|NCT02028182|141527081|OTHER||Kappa statistic-Concordance 0.4 mg/cm2|75.0|||||TWO_SIDED|95.0|60.4|94.0||||||||94.0|60.4|
71010102|NCT02028182|141527081|OTHER||Kappa statistic: Concordance 0.20 mg/cm2|65.0|||||TWO_SIDED|95.0|55.6|90.4||||||||90.4|55.6|
71010103|NCT02028182|141527081|OTHER||Kappa statistic: Concordance0.10 mg/cm2|60.0|||||TWO_SIDED|95.0|53.3|88.4||||||||88.4|53.3|
71010104|NCT01519648|141527084|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.872|STANDARD_ERROR_OF_MEAN|0.237||0.007|TWO_SIDED|95.0|1.178|2.977|||Chi-squared|||||2.977|1.178|0.007
71010105|NCT04524663|141527092|SUPERIORITY||Median Difference (Net)|0.59||||0.89|TWO_SIDED|95.0|-8.14|9.32|||Regression, Linear|||||9.32|-8.14|0.89
70928398|NCT03952338|141352389|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.7|TWO_SIDED|95.0|-0.37|0.55|||Mixed Models Analysis|||Total vegetables||0.55|-0.37|0.70
70928399|NCT03952338|141352389|SUPERIORITY||Median Difference (Final Values)|-0.07||||0.85|TWO_SIDED|95.0|-0.84|0.69|||Mixed Models Analysis|||Greens and beans||0.69|-0.84|0.85
70928400|NCT03952338|141352389|SUPERIORITY|Total fruits|Mean Difference (Final Values)|0.34||||0.29|TWO_SIDED|95.0|-0.29|0.98|||Mixed Models Analysis|||||0.98|-0.29|0.29
71010106|NCT04524663|141527093|SUPERIORITY||Median Difference (Net)|18.9||||0.02|TWO_SIDED|95.0|2.98|34.83|||Regression, Linear|||||34.83|2.98|0.02
71010107|NCT04524663|141527094|SUPERIORITY||Hazard Ratio (HR)|1.69||||0.24|TWO_SIDED|95.0|0.7|4.1|||Cox proportional hazards model|||||4.10|0.70|0.24
71010108|NCT04524663|141527095|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
71010109|NCT04524663|141527096|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.24|TWO_SIDED|95.0|0.32|1.33|||Cox proportional hazards model|||||1.33|0.32|0.24
71010110|NCT00337935|141527099|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0062|TWO_SIDED|95.0|0.2|0.9||a priori theshold for statistical significance was p=0.05|ANCOVA|Baseline Hemoglobin was used as a covariate.||||0.9|0.2|.0062
71010111|NCT00337935|141527100|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance p=0.05|Chi-squared|||||||<0.001
70928401|NCT03952338|141352389|SUPERIORITY||Median Difference (Final Values)|0.6||||0.07|TWO_SIDED|95.0|-0.06|1.26|||Mixed Models Analysis|||Whole fruits||1.26|-0.06|0.07
70928402|NCT03952338|141352389|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.92|TWO_SIDED|95.0|-1.16|1.05|||Mixed Models Analysis|||Whole grains||1.05|-1.16|0.92
70928403|NCT03952338|141352389|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.72|TWO_SIDED|95.0|-1.29|0.89|||Mixed Models Analysis|||Dairy||0.89|-1.29|0.72
70928404|NCT03952338|141352389|SUPERIORITY||Mean Difference (Final Values)|0.31||||0.15|TWO_SIDED|95.0|-0.12|0.74|||Mixed Models Analysis|||Total protein||0.74|-0.12|0.15
70928405|NCT03952338|141352389|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.92|TWO_SIDED|95.0|-0.78|0.71|||Mixed Models Analysis|||Seafood and plant proteins||0.71|-0.78|0.92
71046363|NCT00518882|141601150|SUPERIORITY_OR_OTHER||Mean|0.26|STANDARD_DEVIATION|4.158||0.3859||95.0|-0.331|0.853|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.853|-0.331|0.3859
71046364|NCT00518882|141601150|SUPERIORITY_OR_OTHER||Mean|-0.37|STANDARD_DEVIATION|3.838||0.2119||95.0|-0.956|0.214|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.214|-0.956|0.2119
71046365|NCT00518882|141601151|SUPERIORITY_OR_OTHER||Mean|-0.35|STANDARD_DEVIATION|3.975||0.229||95.0|-0.917|0.2211|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.2211|-0.917|0.2290
71046366|NCT00518882|141601151|SUPERIORITY_OR_OTHER||Mean|-0.95|STANDARD_DEVIATION|3.23||0.0002||95.0|-1.449|-0.459|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.459|-1.449|0.0002
70928406|NCT03952338|141352389|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.67|TWO_SIDED|95.0|-1.47|0.94|||Mixed Models Analysis|||Fatty acids||0.94|-1.47|0.67
70928407|NCT03952338|141352389|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.61|TWO_SIDED|95.0|-1.45|0.84|||Mixed Models Analysis|||Sodium||0.84|-1.45|0.61
71046367|NCT00518882|141601152|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.73||||0.0124||95.0|0.16|1.31||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||1.31|0.16|0.0124
71046368|NCT00518882|141601153|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.39||||0.143||95.0|-0.91|0.13||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||0.13|-0.91|0.1430
70928408|NCT03952338|141352389|SUPERIORITY||Mean Difference (Final Values)|-1.15||||0.06|TWO_SIDED|95.0|-2.34|0.04|||Mixed Models Analysis|||Refined grains||0.04|-2.34|0.06
70928409|NCT03952338|141352389|SUPERIORITY||Mean Difference (Final Values)|0.53||||0.32|TWO_SIDED|95.0|-0.51|1.57|||Mixed Models Analysis|||Saturated fats||1.57|-0.51|0.32
70928410|NCT03952338|141352389|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.63|TWO_SIDED|95.0|-0.56|0.92|||Mixed Models Analysis|||Added sugars||0.92|-0.56|0.63
70928411|NCT03952338|141352390|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.85|TWO_SIDED|95.0|-0.61|0.5|||Mixed Models Analysis|||Total vegetables||0.50|-0.61|0.85
70928412|NCT03952338|141352390|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.82|TWO_SIDED|95.0|-0.88|0.7|||Mixed Models Analysis|||Greens and beans||0.70|-0.88|0.82
70928413|NCT03952338|141352390|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.48|TWO_SIDED|95.0|-0.43|0.93|||Mixed Models Analysis|||Total fruits||0.93|-0.43|0.48
70928414|NCT03952338|141352390|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.06|TWO_SIDED|95.0|-0.04|1.46|||Mixed Models Analysis|||Whole fruits||1.46|-0.04|0.06
70928415|NCT03952338|141352390|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.34|TWO_SIDED|95.0|-0.63|1.84|||Mixed Models Analysis|||Whole grains||1.84|-0.63|0.34
70928416|NCT03952338|141352390|SUPERIORITY||Mean Difference (Final Values)|1.47||||0.01|TWO_SIDED|95.0|0.31|2.62|||Mixed Models Analysis|||Dairy||2.62|0.31|0.01
70928417|NCT03952338|141352390|SUPERIORITY||Median Difference (Final Values)|0.21||||0.39|TWO_SIDED|95.0|-0.27|0.69|||Mixed Models Analysis|||Total protein||0.69|-0.27|0.39
70928418|NCT03952338|141352390|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.81|TWO_SIDED|95.0|-0.9|0.7|||Mixed Models Analysis|||Seafood and plant proteins||0.70|-0.90|0.81
70928419|NCT03952338|141352390|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.04|TWO_SIDED|95.0|-2.57|-0.04|||Mixed Models Analysis|||Fatty acids||-0.04|-2.57|0.04
70928420|NCT03952338|141352390|SUPERIORITY||Mean Difference (Final Values)|-0.69||||0.25|TWO_SIDED|95.0|-1.86|0.48|||Mixed Models Analysis|||Sodium||0.48|-1.86|0.25
70928421|NCT03952338|141352390|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.91|TWO_SIDED|95.0|-1.25|1.4|||Mixed Models Analysis|||Refined grains||1.40|-1.25|0.91
70928422|NCT03952338|141352390|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.89|TWO_SIDED|95.0|-0.98|1.13|||Mixed Models Analysis|||Saturated fats||1.13|-0.98|0.89
70928423|NCT03952338|141352390|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.59|TWO_SIDED|95.0|-0.55|0.97|||Mixed Models Analysis|||Added sugars||0.97|-0.55|0.59
70928424|NCT03952338|141352391|SUPERIORITY||Risk Ratio (RR)|0.15||||0.01|TWO_SIDED|95.0|0.03|0.67||Marginal food insecurity|Mixed Models Analysis|Mixed effects multinomial logistic regression||||0.67|0.03|0.01
70928425|NCT03952338|141352391|SUPERIORITY||Risk Ratio (RR)|0.56||||0.34|TWO_SIDED|95.0|0.17|1.82|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Moderate food insecurity||1.82|0.17|0.34
70928426|NCT03952338|141352391|SUPERIORITY||Risk Ratio (RR)|0.16||||0.02|TWO_SIDED|95.0|0.03|0.76|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Severe food insecurity||0.76|0.03|0.02
70928427|NCT03952338|141352392|SUPERIORITY||Risk Ratio, log|0.28||||0.1|TWO_SIDED|95.0|0.06|1.29|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Marginal food insecurity||1.29|0.06|0.10
70928428|NCT03952338|141352392|SUPERIORITY||Risk Ratio (RR)|0.68||||0.52|TWO_SIDED|95.0|0.21|2.21|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Moderate food insecurity||2.21|0.21|0.52
70928429|NCT03952338|141352392|SUPERIORITY||Risk Ratio (RR)|0.11||||0.01|TWO_SIDED|95.0|0.02|0.56|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Severe food insecurity||0.56|0.02|0.01
70928430|NCT03952338|141352393|SUPERIORITY||Risk Ratio (RR)|2.94||||0.15|TWO_SIDED|95.0|0.68|12.66|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Medium malnutrition risk||12.66|0.68|0.15
71046369|NCT00518882|141601154|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.54||||0.038||95.0|0.03|1.05||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||1.05|0.03|0.0380
70928431|NCT03952338|141352393|SUPERIORITY||Risk Ratio (RR)|1.18||||0.86|TWO_SIDED|95.0|0.2|7.13|||Mixed Models Analysis|Mixed effects multinomial logistic regression||High malnutrition risk||7.13|0.20|0.86
70928432|NCT03952338|141352394|SUPERIORITY||Risk Ratio (RR)|1.28||||0.74|TWO_SIDED|95.0|0.31|5.38|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Medium malnutrition risk||5.38|0.31|0.74
70928433|NCT03952338|141352394|SUPERIORITY||Risk Ratio (RR)|5.48||||0.1|TWO_SIDED|95.0|0.73|41.3|||Mixed Models Analysis|Mixed effects multinomial logistic regression||High malnutrition risk||41.3|0.73|0.10
70928434|NCT03952338|141352395|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.64|TWO_SIDED|95.0|-0.65|0.4|||Mixed Models Analysis|||||0.40|-0.65|0.64
70928435|NCT03952338|141352396|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.9|TWO_SIDED|95.0|-0.57|0.5|||Mixed Models Analysis|||||0.50|-0.57|0.90
70928436|NCT03952338|141352397|SUPERIORITY||Mean Difference (Final Values)|-4.07||||0.43|TWO_SIDED|95.0|-14.05|5.92||Males|Mixed Models Analysis|||||5.92|-14.05|0.43
70928437|NCT03952338|141352397|SUPERIORITY||Mean Difference (Final Values)|0.45||||0.83|TWO_SIDED|95.0|-3.75|4.66|||Mixed Models Analysis|||Females||4.66|-3.75|0.83
70928438|NCT03952338|141352398|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.66|TWO_SIDED|95.0|-5.65|3.57||Age 18-59 years|Mixed Models Analysis|||||3.57|-5.65|0.66
70928439|NCT03952338|141352398|SUPERIORITY||Mean Difference (Final Values)|3.28||||0.4|TWO_SIDED|95.0|-4.36|10.93|||Mixed Models Analysis|||Age 60+ years||10.93|-4.36|0.40
70928440|NCT03952338|141352399|SUPERIORITY||Mean Difference (Final Values)|6.25||||0.43|TWO_SIDED|95.0|-9.13|21.63|||Mixed Models Analysis|||Males||21.63|-9.13|0.43
70928441|NCT03952338|141352399|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.62|TWO_SIDED|95.0|-3.23|5.41|||Mixed Models Analysis|||Females||5.41|-3.23|0.62
70928442|NCT03952338|141352400|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.99|TWO_SIDED|95.0|-4.76|4.66|||Mixed Models Analysis|||18-59 years||4.66|-4.76|0.99
70928443|NCT03952338|141352400|SUPERIORITY||Mean Difference (Final Values)|3.66||||0.43|TWO_SIDED|95.0|-5.48|12.8|||Mixed Models Analysis|||60+ years||12.80|-5.48|0.43
70928444|NCT05274074|141352541|SUPERIORITY||Mean Difference (Net)|1.4||||0.57|TWO_SIDED|95.0|-3.4|6.2|||Regression, Linear|||||6.2|-3.4|0.57
70928445|NCT05274074|141352542|SUPERIORITY||Mean Difference (Net)|-0.1||||0.53|TWO_SIDED|95.0|-0.5|0.2|||Regression, Linear|||||0.2|-0.5|0.53
70928446|NCT05274074|141352543|SUPERIORITY||Mean Difference (Net)|-1.0||||0.41|TWO_SIDED|95.0|-3.3|1.4|||Regression, Linear|||||1.4|-3.3|0.41
70928447|NCT05274074|141352544|SUPERIORITY||Mean Difference (Net)|-0.9||||0.45|TWO_SIDED|95.0|-3.5|1.6|||Regression, Linear|||||1.6|-3.5|0.45
70928448|NCT05274074|141352545|SUPERIORITY||Mean Difference (Net)|3.3||||0.02|TWO_SIDED|95.0|0.5|6.2|||Regression, Linear|||||6.2|0.5|0.02
70928449|NCT05274074|141352546|SUPERIORITY||Mean Difference (Net)|-0.8||||0.69|TWO_SIDED|95.0|-4.9|3.3|||Regression, Linear|||||3.3|-4.9|0.69
70928450|NCT01828099|141352547|SUPERIORITY||Hazard Ratio (HR)|0.55|||<|0.001|TWO_SIDED|95.0|0.42|0.73|||Log Rank|||||0.73|0.42|<0.001
70928451|NCT05875467|141352573|SUPERIORITY|||||||0.042|||||||t-test, 2 sided|||||||.042
70928452|NCT05875467|141352574|SUPERIORITY|||||||0.928|||||||t-test, 2 sided|||||||.928
70928453|NCT05875467|141352575|SUPERIORITY|||||||0.022|||||||t-test, 2 sided|||||||.022
70928454|NCT05875467|141352576|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||.004
70928455|NCT04568434|141352589|SUPERIORITY||LS mean difference|-43.5|||=|0.0009|TWO_SIDED|95.0|-69.085|-17.921||ANCOVA model included effects of treatment (olezarsen 80 mg, olezarsen 50 mg, or placebo): dependent variable, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline TG: covariate.|ANCOVA|||||-17.921|-69.085|=0.0009
70928456|NCT04568434|141352589|SUPERIORITY||Least squares (LS) mean difference|-22.37|||=|0.0775|TWO_SIDED|95.0|-47.2|2.463||Analysis of covariance (ANCOVA) model included effects of treatment (olezarsen 80 mg, olezarsen 50 mg, or placebo): dependent variable, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline TG: covariate.|ANCOVA|||||2.463|-47.200|=0.0775
70928457|NCT04568434|141352590|SUPERIORITY||LS mean difference|-43.81|||=|0.0044|TWO_SIDED|95.0|-73.928|-13.692||ANCOVA model included percent change from baseline in fasting TG at Month 12: dependent variable, treatment group, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline TG: covariate.|ANCOVA|||||-13.692|-73.928|=0.0044
70928458|NCT04568434|141352590|SUPERIORITY||LS mean difference|-59.39|||=|0.0002|TWO_SIDED|95.0|-90.663|-28.119||ANCOVA model included percent change from baseline in fasting TG at Month 12: dependent variable, treatment group, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline TG: covariate.|ANCOVA|||||-28.119|-90.663|=0.0002
70928459|NCT04568434|141352591|SUPERIORITY||LS mean difference|-65.48|||<|0.0001|TWO_SIDED|95.0|-82.634|-48.32||ANCOVA model included percent change from baseline in fasting apoC-III at Month 6: dependent variable, treatment group, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline apoC-III: covariate.|ANCOVA|||Percent Change from Baseline at Month 6||-48.320|-82.634|<0.0001
70928460|NCT04568434|141352591|SUPERIORITY||LS mean difference|-73.69|||<|0.0001|TWO_SIDED|95.0|-94.553|-52.837||ANCOVA model included percent change from baseline in fasting apoC-III at Month 6: dependent variable, treatment group, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline apoC-III: covariate.|ANCOVA|||Percent Change from Baseline at Month 6||-52.837|-94.553|<0.0001
70928461|NCT04568434|141352591|SUPERIORITY||Ls mean difference|-77.06|||<|0.0001|TWO_SIDED|95.0|-98.938|-55.177||ANCOVA model included percent change from baseline in fasting apoC-III at Month 12: dependent variable, treatment group, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline apoC-III: covariate.|ANCOVA|||Percent Change from Baseline at Month 12||-55.177|-98.938|<0.0001
70928462|NCT04568434|141352591|SUPERIORITY||LS mean difference|-81.28|||<|0.0001|TWO_SIDED|95.0|-104.656|-57.894||ANCOVA model included percent change from baseline in fasting apoC-III at Month 12: dependent variable, treatment group, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline apoC-III: covariate.|ANCOVA|||Percent Change from Baseline at Month 12||-57.894|-104.656|<0.0001
70928463|NCT04568434|141352593|SUPERIORITY||LS mean difference|-33.29|||=|0.186|TWO_SIDED|95.0|-82.612|16.041||ANCOVA model included percent change from baseline in fasting apoB-48 to Month 6: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline apoB-48: covariate.|ANCOVA|||Percent Change From Baseline at Month 6||16.041|-82.612|=0.1860
70928464|NCT04568434|141352593|SUPERIORITY||LS mean difference|-83.97|||=|0.0019|TWO_SIDED|95.0|-136.949|-30.982||ANCOVA model included percent change from baseline in fasting apoB-48 to Month 6: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline apoB-48: covariate.|ANCOVA|||Percent Change From Baseline at Month 6||-30.982|-136.949|=0.0019
71046370|NCT00518882|141601155|SUPERIORITY_OR_OTHER||Mean|0.06|STANDARD_DEVIATION|2.827||0.77||95.0|-0.344|0.463|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.463|-0.344|0.7700
70928465|NCT04568434|141352593|SUPERIORITY||LS mean difference|-32.9|||=|0.4219|TWO_SIDED|95.0|-113.254|47.459||ANCOVA model included percent change from baseline in fasting apoB-48 to Month 12: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline apoB-48: covariate.|ANCOVA|||Percent Change from Baseline at Month 12||47.459|-113.254|=0.4219
70928466|NCT04568434|141352593|SUPERIORITY||LS mean difference|-75.63|||=|0.056|TWO_SIDED|95.0|-153.195|1.927||ANCOVA model included percent change from baseline in fasting apoB-48 to Month 12: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline apoB-48: covariate.|ANCOVA|||Percent Change from Baseline at Month 12||1.927|-153.195|=0.0560
70928467|NCT04568434|141352594|SUPERIORITY||LS mean difference|-17.69|||=|0.0401|TWO_SIDED|95.0|-34.571|-0.801||ANCOVA model included percent change from baseline in fasting non-HDL-C to Month 6: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline non-HDL-C: covariate.|ANCOVA|||Percent Change from Baseline Month 6||-0.801|-34.571|=0.0401
70928468|NCT04568434|141352594|SUPERIORITY||LS mean difference|-24.2|||=|0.0036|TWO_SIDED|95.0|-40.484|-7.911||ANCOVA model included percent change from baseline in fasting non-HDL-C to Month 6: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline non-HDL-C: covariate|ANCOVA|||Percent Change from Baseline Month 6||-7.911|-40.484|=0.0036
70928469|NCT04568434|141352594|SUPERIORITY||LS mean difference|-29.84|||=|0.0134|TWO_SIDED|95.0|-53.49|-6.198||ANCOVA model included percent change from baseline in fasting non-HDL-C to Month 12: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline non-HDL-C: covariate.|ANCOVA|||Percent Change from Baseline at Month 12||-6.198|-53.490|=0.0134
70928470|NCT04568434|141352594|SUPERIORITY||LS mean difference|-39.7|||=|0.0009|TWO_SIDED|95.0|-63.108|-16.292||ANCOVA model included percent change from baseline in fasting non-HDL-C to Month 12: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline non-HDL-C: covariate.|ANCOVA|||Percent Change from Baseline at Month 12||-16.292|-63.108|=0.0009
70928471|NCT04568434|141352595|SUPERIORITY||Mean Rate Ratio|0.1|||=|0.0052|TWO_SIDED|95.0|0.02|0.506||Regression model: treatment group \& previous treatment (volanesorsen):factors adjudicated acute pancreatitis events in 5 years prior enrollment:covariate. Logarithm of time in year that each participant was observed from Week 1 to 53:offset variable.|Negative Binomial Regression Model|||||0.506|0.020|=0.0052
70928472|NCT04568434|141352596|SUPERIORITY||Mean Rate Ratio|0.12|||=|0.0144|TWO_SIDED|95.0|0.022|0.656||Regression model: treatment group \& previous treatment (volanesorsen):factors adjudicated acute pancreatitis events in 5 years prior enrollment:covariate. Logarithm of time in year that each participant was observed from Week 1 to 53:offset variable.|Negative Binomial Regression Model|||||0.656|0.022|=0.0144
70928473|NCT04568434|141352597|SUPERIORITY||Mean Rate Ratio|0.14|||=|0.0174|TWO_SIDED|95.0|0.028|0.709||Regression model: treatment group \& previous treatment (volanesorsen):factors adjudicated acute pancreatitis events in 5 years prior enrollment:covariate. Logarithm of time in year that each participant was observed from Week 13 to 53:offset variable|Negative Binomial Regression Model|||||0.709|0.028|=0.0174
71046371|NCT00518882|141601155|SUPERIORITY_OR_OTHER||Mean|0.72|STANDARD_DEVIATION|3.27||0.0042||95.0|0.23|1.212|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||1.212|0.230|0.0042
71046372|NCT00518882|141601156|SUPERIORITY_OR_OTHER||Mean|0.67|STANDARD_DEVIATION|3.041||0.0026||95.0|0.238|1.106|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||1.106|0.238|0.0026
71010112|NCT00337935|141527101|SUPERIORITY_OR_OTHER||||||<|0.0001||||||A priori threshold for statistical significance p=0.05|Log Rank|||||||<0.0001
71010113|NCT02361307|141527120|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
71010114|NCT00711009|141527121|NON_INFERIORITY_OR_EQUIVALENCE|The exact 95% confidence interval for the difference in response rates (LPV/r + RAL minus LPV/r + FTC/TDF) was used to assess non-inferiority. The LPV/r+RAL arm was considered non-inferior to the LPV/r+FTC/TDF arm because the lower limit of the confidence interval was \>/= -20%. Because the LPV/r+RAL arm was considered non-inferior based on the 20% margin, the results were assessed on a more rigorous 12% margin (-12%), as prespecified.|Diff. in Percentage of Subj. Responding|-1.6||||0.85|TWO_SIDED|95.0|-12.0|8.8|||exact binomial method|||The null hypothesis was that the response rate for the LPV/r + RAL arm was more than 20% lower than the response rate for the LPV/r + FTC/TDF arm. The planned sample size of 100 participants per treatment group provided 90% power to conclude that the LPV/r + RAL arm was non-inferior to the control arm, based on a non-inferiority margin of -20% (with a type I error rate of 0.05).||8.8|-12.0|0.850
71010115|NCT01682876|141527210|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 2 to 5 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenA|Vaccine Group Differences at Day 86|19.0|||||TWO_SIDED|97.5|10.0|28.9|||MN method|||Non-inferiority of seroresponse of two vaccinations vs.one vaccination for age cohort (2 to 5 years of age) for MenA||28.9|10|
71010116|NCT01682876|141527210|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 2 to 5 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenC|Vaccine Group Differences at Day 86|27.0|||||TWO_SIDED|97.5|16.9|37.7|||MN method|||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (2 to 5 years of age) for MenC||37.7|16.9|
71010117|NCT01682876|141527210|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 2 to 5 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenW|Vaccine Group Differences at Day 86|14.0|||||TWO_SIDED|97.5|1.4|26.7|||MN method|||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (2 to 5 years of age) for MenW||26.7|1.4|
71010118|NCT01682876|141527210|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 2 to 5 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for Men Y|Vaccine Group differences at Day 86|27.0|||||TWO_SIDED|97.5|15.6|37.6|||MN method|||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (2 to 5 years of age) for MenY||37.6|15.6|
71010119|NCT01682876|141527210|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 6 to 10 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenA|Vaccines Group Differences at Day 86|11.0|||||TWO_SIDED|97.5|1.7|21.3|||MN method|||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenA||21.3|1.7|
71010120|NCT01682876|141527210|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 6 to 10 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenC|Vaccines Group differences at Day 86|19.0|||||TWO_SIDED|97.5|9.9|29.2|||MN method|||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenC||29.2|9.9|
71046373|NCT00518882|141601156|SUPERIORITY_OR_OTHER||Mean|-0.09|STANDARD_DEVIATION|2.989||0.6845||95.0|-0.541|0.356|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.356|-0.541|0.6845
71046374|NCT00518882|141601157|SUPERIORITY_OR_OTHER||Mean|0.32|STANDARD_DEVIATION|2.705||0.1041||95.0|-0.066|0.706|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.706|-0.066|0.1041
71010121|NCT01682876|141527210|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 6 to 10 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenW|Vaccines Group Differences at Day 86|4.0|||||TWO_SIDED|97.5|-8.6|17.4|||MN method|||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenW||17.4|-8.6|
71046375|NCT00518882|141601157|SUPERIORITY_OR_OTHER||Mean|0.58|STANDARD_DEVIATION|3.114||0.0151||95.0|0.114|1.052|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||1.052|0.114|0.0151
71103562|NCT02507934|141714866|SUPERIORITY||Mean Difference (Final Values)|2.78||||0.3167|TWO_SIDED|95.0|-2.78|8.35||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Burning/ Stinging - Right eye||8.35|-2.78|0.3167
71010122|NCT01682876|141527210|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 6 to 10 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenY|Vaccines Group Differences at Day 86|29.0|||||TWO_SIDED|97.5|18.4|40.0|||MN method|||Non-inferiority of seroresponse for two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenY||40|18.4|
71010123|NCT01682876|141527211|SUPERIORITY_OR_OTHER||Vaccine Group Differences at Day 86|18.0|||||TWO_SIDED|98.75|9.1|28.0|||MN method|||Superiority for age cohort (2 through 5 years of age) for MenA was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenA||28|9.1|
71010124|NCT01682876|141527211|SUPERIORITY_OR_OTHER||Vaccine Group Differences at Day 86|28.0||||||98.75|17.1|38.7|||MN method|||Superiority for age cohort (2 through 5 years of age) for MenC was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenC||38.7|17.1|
71010125|NCT01682876|141527211|SUPERIORITY_OR_OTHER||Vaccine Group differences at Day 86|14.0|||||TWO_SIDED|98.75|1.0|27.1|||MN method|||Superiority for age cohort (2 through 5 years of age) for MenW was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenW||27.1|1|
71010126|NCT01682876|141527211|SUPERIORITY_OR_OTHER||Vaccine groups Differences at Day 86|28.0|||||TWO_SIDED|98.75|16.2|39.3|||MN method|||Superiority for age cohort (2 through 5 years of age) for MenY was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenY||39.3|16.2|
71010127|NCT01682876|141527211|SUPERIORITY_OR_OTHER||Vaccine groups differences at Day 86|11.0|||||TWO_SIDED|98.75|1.0|21.2|||MN method|||Superiority for age cohort (6 through 10 years of age) for MenA was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenA||21.2|1|
71010128|NCT01682876|141527211|SUPERIORITY_OR_OTHER||Vaccine Group differences at Day 86|18.0|||||TWO_SIDED|97.5|9.5|27.1|||MN method|||Superiority for age cohort (6 through 10 years of age) for MenC was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenC||27.1|9.5|
71010129|NCT01682876|141527211|SUPERIORITY_OR_OTHER||Vaccine Group Differences at Day 86|5.0|||||TWO_SIDED|98.75|-8.4|18.8|||MN method|||Superiority for age cohort (6 through 10 years of age) for MenW was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenW||18.8|-8.4|
71046376|NCT00518882|141601158|SUPERIORITY_OR_OTHER||Mean|-3.31|STANDARD_DEVIATION|3.857|<|0.0001||95.0|-3.861|-2.763|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-2.763|-3.861|<0.0001
71046377|NCT00518882|141601158|SUPERIORITY_OR_OTHER||Mean|-3.13|STANDARD_DEVIATION|3.56|<|0.0001||95.0|-3.673|-2.589|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-2.589|-3.673|<0.0001
71046378|NCT00518882|141601159|SUPERIORITY_OR_OTHER||Mean|-1.93|STANDARD_DEVIATION|3.703|<|0.0001||95.0|-2.457|-1.403|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-1.403|-2.457|<0.0001
71103563|NCT02507934|141714866|SUPERIORITY||Mean Difference (Final Values)|-1.84||||0.5243|TWO_SIDED|95.0|-7.64|3.96||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Itching - Left eye||3.96|-7.64|0.5243
71010130|NCT01682876|141527211|SUPERIORITY_OR_OTHER||Vaccine group Differences at Day 86|29.0|||||TWO_SIDED|98.75|17.0|39.6|||MN method|||Superiority for age cohort (6 through 10 years of age) for MenY was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenY||39.6|17|
71010131|NCT01682876|141527216|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.3|||||TWO_SIDED|95.0|1.17|4.53||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced erythema in the two doses versus in the one dose of MenACWY-CRM||4.53|1.17|
71010132|NCT01682876|141527216|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.75|||||TWO_SIDED|95.0|1.18|6.36||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced induration in the two doses versus in the one dose of MenACWY-CRM||6.36|1.18|
71010133|NCT01682876|141527216|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07|||||TWO_SIDED|95.0|0.85|1.34||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced tenderness in the two doses versus in the one dose of MenACWY-CRM||1.34|0.85|
70928474|NCT04568434|141352598|SUPERIORITY||Mean Rate Ratio|0.16|||=|0.0314|TWO_SIDED|95.0|0.031|0.85||Regression model: treatment group \& previous treatment (volanesorsen):factors adjudicated acute pancreatitis events in 5 years prior enrollment:covariate. Logarithm of time in year that each participant was observed from Week 13 to 53:offset variable|Negative Binomial Regression Model|||||0.850|0.031|=0.0314
70928475|NCT04568434|141352601|SUPERIORITY||Mean Rate Ratio|0.14|||=|0.0137|TWO_SIDED|95.0|0.029|0.669||Regression model: treatment group \& previous treatment (volanesorsen):factors adjudicated acute pancreatitis events in 5 years prior enrollment:covariate. Logarithm of time in year that each participant was observed from Week 1 to 53:offset variable|Negative Binomial Regression Model|||||0.669|0.029|=0.0137
70928476|NCT04568434|141352602|SUPERIORITY||Mean Rate Ratio|0.2|||=|0.048|TWO_SIDED|95.0|0.04|0.986||Regression model:treatment group \& previous treatment (volanesorsen):factors adjudicated acute pancreatitis events in 5 years prior enrollment:covariate. Logarithm of time in year that each participant was observed from Week 13 to 53:offset variable|Negative Binomial Regression Model|||||0.986|0.040|=0.0480
70928478|NCT05485779|141352623|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.17||||0.6358|TWO_SIDED|95.0|1.07|1.27|||Lack of fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 30.4. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error.|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 3 to 60 mg AQ280||1.27|1.07|0.6358
71010134|NCT01682876|141527216|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.54|1.42||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced change in eating habits in the two doses versus in the one dose of MenACWY-CRM||1.42|0.54|
71010135|NCT01682876|141527216|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.76|1.52||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced sleepiness in the two doses versus in the one dose of MenACWY-CRM||1.52|0.76|
71010136|NCT01682876|141527216|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.74|1.43||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced irritability in the two doses versus in the one dose of MenACWY-CRM||1.43|0.74|
71010137|NCT01682876|141527216|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.33|1.74||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced fever (≥38 °C) in the two doses versus in the one dose of MenACWY-CRM||1.74|0.33|
71010138|NCT01682876|141527217|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.43|||||TWO_SIDED|95.0|0.77|2.65||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced erythema in the two doses versus in the one dose of MenACWY-CRM||2.65|0.77|
71010139|NCT01682876|141527217|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.49|||||TWO_SIDED|95.0|0.81|2.74||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced induration in the two doses versus in the one dose of MenACWY-CRM||2.74|0.81|
70928479|NCT05485779|141352623|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.13||||0.5506|TWO_SIDED|95.0|0.963|1.31|||Lack of Fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 32.9. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error.|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 9 to 60 mg AQ280||1.31|0.963|0.5506
71010140|NCT01682876|141527217|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.27|||||TWO_SIDED|95.0|1.04|1.55||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced pain in the two doses versus in the one dose of MenACWY-CRM||1.55|1.04|
70928480|NCT05485779|141352624|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.13||||0.3653|TWO_SIDED|95.0|1.04|1.22|||Lack of Fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 25.7. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 3 to 60 mg AQ280||1.22|1.04|0.3653
70928481|NCT05485779|141352624|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.16||||0.2933|TWO_SIDED|95.0|1.01|1.31|||Lack of Fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 27.7. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 9 to 60 mg AQ280||1.31|1.01|0.2933
71010141|NCT01682876|141527217|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.81|||||TWO_SIDED|95.0|0.98|3.33||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced loss of appetite in the two doses versus in the one dose of MenACWY-CRM||3.33|0.98|
71010142|NCT01682876|141527217|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.29|||||TWO_SIDED|95.0|0.77|2.17||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced nausea in the two doses versus in the one dose of MenACWY-CRM||2.17|0.77|
71010143|NCT01682876|141527217|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.65|||||TWO_SIDED|95.0|1.06|2.57||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced fatigue in the two doses versus in the one dose of MenACWY-CRM||2.57|1.06|
71010144|NCT01682876|141527217|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.37|||||TWO_SIDED|95.0|0.99|1.89||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced myalgia in the two doses versus in the one dose of MenACWY-CRM||1.89|0.99|
71010145|NCT01682876|141527217|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.07|||||TWO_SIDED|95.0|0.97|4.42||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced arthralgia in the two doses versus in the one dose of MenACWY-CRM||4.42|0.97|
70928482|NCT05485779|141352625|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.16||||0.46|TWO_SIDED|95.0|0.908|1.41|||Lack of Fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 64.3. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error|Statistical Analysis of Metabolite AQ282 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 3 to 60 mg AQ280||1.41|0.908|0.4600
70928483|NCT05485779|141352625|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.12||||0.3157|TWO_SIDED|95.0|0.795|1.45|||Lack of Fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 65.6. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error|Statistical Analysis of Metabolite AQ282 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 9 to 60 mg AQ280||1.45|0.795|0.3157
70928484|NCT05485779|141352626|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.2||||0.235|TWO_SIDED|95.0|1.02|1.37|||Lack of fit 1-sided p-value|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 54.2. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error.|Statistical Analysis of Metabolite AQ282 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 3 to 60 mg AQ280||1.37|1.02|0.2350
70928485|NCT05485779|141352626|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.19||||0.1632|TWO_SIDED|95.0|0.88|1.5|||Lack of fit 1-sided p-value|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 58.5. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error.|Statistical Analysis of Metabolite AQ282 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 9 to 60 mg AQ280||1.50|0.880|0.1632
70928486|NCT05485779|141352627|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|0.977|||||TWO_SIDED|90.0|0.915|1.04|||||Within-subject geometric coefficient of variation was 5.66. Data analyzed using a mixed model included treatment as a fixed effect and subject as a random effect. ln(parameter)=treatment+subject+random error, with subject fitted as a random effect.|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess the Effect of Food on Single Oral Doses of 16 mg AQ280||1.04|0.915|
70928487|NCT05485779|141352628|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|0.805|||||TWO_SIDED|90.0|0.635|1.02|||||Within-subject geometric coefficient of variation was 20.5. Data analyzed using a mixed model included treatment as a fixed effect and subject as a random effect. ln(parameter)=treatment+subject+random error, with subject fitted as a random effect.|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess the Effect of Food on Single Oral Doses of 16 mg AQ280||1.02|0.635|
70928488|NCT05485779|141352630|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.15||||0.1558|TWO_SIDED|95.0|0.954|1.34|||Lack of fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 28.0. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Multiple Oral Doses of 9 to 60 mg AQ280 QD for 7 Consecutive Days in a Fasted State||1.34|0.954|0.1558
70928489|NCT05485779|141352631|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.1||||0.5458|TWO_SIDED|95.0|0.946|1.26|||Lack of Fit 2-sided model|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 24.0. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Multiple Oral Doses of 9 to 60 mg AQ280 QD for 7 Consecutive Days in a Fasted State||1.26|0.946|0.5458
70928490|NCT05485779|141352632|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|0.941||||0.4856|TWO_SIDED|95.0|0.602|1.28||Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Lack of fit 2-sided||Between-subject geometric coefficient of variation was 54.7. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error.|Statistical Analysis of Metabolite AQ282 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Multiple Oral Doses of 9 to 60 mg AQ280 once daily for 7 Consecutive Days in a Fasted State||1.28|0.602|0.4856
71010146|NCT01682876|141527217|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.83|||||TWO_SIDED|95.0|1.22|2.74||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced headache in the two doses versus in the one dose of MenACWY-CRM||2.74|1.22|
71010147|NCT01682876|141527217|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.48|2.68||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced fever (≥38 °C) in the two doses versus in the one dose of MenACWY-CRM||2.68|0.48|
71010148|NCT03852901|141527220|OTHER||Mean Difference (Final Values)|40.717|STANDARD_ERROR_OF_MEAN|4.866|<|0.001|TWO_SIDED|95.0|31.166|50.268||Type III of fixed effects. Num df = 1; Den df = 902.758; F = 70.003; Sig. \< 0.001 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit \& Timepoint; Fixed effects: Visit, Timepoint, Sex, Visit\*Sex||No a-priori power calculation was performed due to the exploratory nature of the study.||50.268|31.166|<0.001
70928491|NCT05485779|141352633|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|0.971||||0.1455|TWO_SIDED|95.0|0.666|1.28|||Lack of fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 45.5. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error.|Statistical Analysis of Metabolite AQ282 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Multiple Oral Doses of 9 to 60 mg AQ280 once daily for 7 Consecutive Days in a Fasted State||1.28|0.666|0.1455
70928492|NCT05093842|141352691|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
70928493|NCT05093842|141352692|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
70928494|NCT05093842|141352693|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
70928495|NCT05093842|141352694|OTHER|Descriptive rates were calculated.|||||||||||||||||Descriptive statistics only|||
70928496|NCT05093842|141352695|OTHER|Descriptive statistics only|||||||||||||||||Descriptive statistics only|||
70928497|NCT05093842|141352696|OTHER|Descriptive statistics only|||||||||||||||||Descriptive statistics only|||
70928498|NCT05093842|141352697|OTHER|Descriptive statistics only|||||||||||||||||Descriptive statistics only|||
70928499|NCT03987022|141352700|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||.16
70928500|NCT03987022|141352701|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
70928501|NCT03987022|141352702|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||.01
70928502|NCT03987022|141352703|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
70928503|NCT03987022|141352704|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||||||.58
70928504|NCT03987022|141352705|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||.47
70928505|NCT03987022|141352706|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
70928506|NCT03987022|141352707|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||.02
70928507|NCT03987022|141352708|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70928508|NCT06201559|141352710|EQUIVALENCE|Point estimate of geometric mean ratio (GMR) of T/R should be between 80.00 -125.00%. If the intra-subject variability for Cmax following replicate administrations of the comparator product was \> 30%, the acceptance criteria for Cmax was widened to a maximum of 69.84-143.19%.|Ratio of Geometric Least Square Means|98.1|||||TWO_SIDED|90.0|86.79|110.91|||||Geometric least square means were combined to perform statistical analysis of T as T1 + T2 and R as R1 + R2.|||110.91|86.79|
70928509|NCT06201559|141352711|EQUIVALENCE|Point estimate of geometric mean ratio (GMR) of T/R should be between 80.00 -125.00%. If the intra-subject variability for AUC(0-t) following replicate administrations of the comparator product was \> 30%, the acceptance criteria for AUC(0-t) was widened to a maximum of 69.84-143.19%.|Ratio of Geometric Least Square Means|97.6|||||TWO_SIDED|90.0|86.86|109.73|||||Geometric least square means were combined to perform statistical analysis of T as T1 + T2 and R as R1 + R2.|||109.73|86.86|
70928510|NCT04248725|141352765|SUPERIORITY||Mean Difference (Net)|-2.7||||0.004|TWO_SIDED||||||Mixed Models Analysis|Models were adjusted for sex, baseline severity, and disability condition.||||||0.004
70928511|NCT04248725|141352766|SUPERIORITY||Mean Difference (Net)|0.59|||<|0.001|TWO_SIDED|95.0|0.3|0.88|||Mixed Models Analysis|||||0.88|0.30|<0.001
70928512|NCT04248725|141352767|SUPERIORITY||Mean Difference (Net)|-0.32||||0.29|TWO_SIDED|95.0|-0.61|-0.03|||Mixed Models Analysis|||||-0.03|-0.61|0.29
70928513|NCT05622812|141352768|SUPERIORITY||Treatment difference|39.0|||<|0.001|TWO_SIDED|95.0|21.6|56.5||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|||56.5|21.6|<0.001
70928514|NCT05622812|141352769|SUPERIORITY||Treatment difference|40.4|||<|0.001|TWO_SIDED|95.0|23.1|57.6||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 6||57.6|23.1|<0.001
70928515|NCT05622812|141352769|SUPERIORITY||Treatment difference|41.7|||<|0.001|TWO_SIDED|95.0|25.6|57.8||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 9||57.8|25.6|<0.001
70928516|NCT05622812|141352769|SUPERIORITY||Treatment difference|30.2||||0.003|TWO_SIDED|95.0|13.2|47.1||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 12||47.1|13.2|0.003
70928517|NCT05622812|141352770|SUPERIORITY||Treatment difference|99.0|||<|0.001|TWO_SIDED|95.0|97.1|100.0||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 3||100.0|97.1|<0.001
70928518|NCT05622812|141352770|SUPERIORITY||Treatment difference|87.6|||<|0.001|TWO_SIDED|95.0|76.9|98.2||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 6||98.2|76.9|<0.001
70928519|NCT05622812|141352770|SUPERIORITY||Treatment difference|80.5|||<|0.001|TWO_SIDED|95.0|68.6|92.4||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 9||92.4|68.6|<0.001
70928520|NCT05622812|141352770|SUPERIORITY||Treatment difference|73.7|||<|0.001|TWO_SIDED|95.0|61.9|85.5||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 12||85.5|61.9|<0.001
70928521|NCT05622812|141352771|SUPERIORITY||Treatment difference|93.1|||<|0.001|TWO_SIDED|95.0|88.2|98.0||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 3||98.0|88.2|<0.001
70928522|NCT05622812|141352771|SUPERIORITY||Treatment difference|87.9|||<|0.001|TWO_SIDED|95.0|81.4|94.3||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 6||94.3|81.4|<0.001
70928523|NCT05622812|141352771|SUPERIORITY||Treatment difference|80.4|||<|0.001|TWO_SIDED|95.0|72.7|88.1||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|||88.1|72.7|<0.001
71010149|NCT03852901|141527221|OTHER||Mean Difference (Final Values)|-0.637|STANDARD_ERROR_OF_MEAN|1.051||0.545|TWO_SIDED|95.0|-2.699|1.426||Type III of fixed effects. Num df = 1; Den df = 884.229; F = .367; Sig = .545 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit \& Timepoint; Fixed effects: Visit, Timepoint, Sex, Visit\*Sex||No a-priori power calculation was performed due to the exploratory nature of the study.||1.426|-2.699|0.545
71010150|NCT03852901|141527222|OTHER||Mean Difference (Final Values)|0.027|STANDARD_ERROR_OF_MEAN|0.009||0.003|TWO_SIDED|95.0|0.009|0.044||Type III of fixed effects. Num df = 1; Den df = 880.629; F = 8.782; Sig. = 0.003 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit \& Timepoint; Fixed effects: Visit, Timepoint, Sex, Visit\*Sex||No a-priori power calculation was performed due to the exploratory nature of the study.||.044|.009|0.003
71010151|NCT03852901|141527223|OTHER||Mean Difference (Final Values)|-2.647|STANDARD_ERROR_OF_MEAN|1.329||0.047|TWO_SIDED|95.0|-5.255|-0.04||Type III of fixed effects. Num df = 1; Den df = 880.870; F = 3.970; Sig. = 0.047 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit \& Timepoint; Fixed effects: Visit, Timepoint, Sex, Visit\*Sex||No a-priori power calculation was performed due to the exploratory nature of the study.||-0.040|-5.255|0.047
71010152|NCT03852901|141527224|OTHER||Mean Difference (Final Values)|-5.573|STANDARD_ERROR_OF_MEAN|1.853||0.003|TWO_SIDED|95.0|-9.21|-1.937||Type III of fixed effects. Num df = 1; Den df = 902.181; F = 9.049; Sig. = 0.003 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit \& Timepoint; Fixed effects: repeated-measures. Visit, Timepoint, Sex, Visit\*Sex||No a-priori power calculation was performed due to the exploratory nature of the study.||-1.937|-9.210|0.003
71010153|NCT03852901|141527225|OTHER|||||||0.5849||||||Type III of fixed effects. Num df: 2; Den df = 33; F = 0.5451; Sig. = 0.5849 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit; Fixed effects: Visit, Sex, Age, fCSF||No a-priori power calculation was performed due to the exploratory nature of the study.||||0.5849
71010154|NCT03852901|141527226|OTHER|||||||0.0142||||||Type III of fixed effects. Num df = 2; Den df = 35; F = 4.8191; Sig. = 0.0142 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit; Fixed effects: Visit, Sex, Age, fCSF||No a-priori power calculation was performed due to the exploratory nature of the study.||||0.0142
71010155|NCT03852901|141527227|OTHER|||||||0.024||||||Type III of fixed effects. Num df: 2; Den df = 34; F = 4.1501; Sig. = 0.0244 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effects: ID; Repeated measures: Visit; Fixed effects: Visit, Sex, Age and fCSF||No a-priori power calculation was performed due to the exploratory nature of the study.||||0.024
71010156|NCT02534324|141527229|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||Chi-squared|||||||0.49
71010157|NCT02534324|141527230|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||t-test, 2 sided|||||||0.15
71010158|NCT01138995|141527231|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Fisher's combination test|Between group difference for entire sample||||||0.75
71010159|NCT01138995|141527232|SUPERIORITY_OR_OTHER||||||<|0.022|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.022
71010160|NCT01138995|141527233|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71103564|NCT02507934|141714866|SUPERIORITY||Mean Difference (Final Values)|1.19||||0.6714|TWO_SIDED|95.0|-4.45|6.82||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Itching - Right eye||6.82|-4.45|0.6714
71103565|NCT02507934|141714866|SUPERIORITY||Mean Difference (Final Values)|-3.89||||0.0828|TWO_SIDED|95.0|-8.31|0.53||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Pain - Left eye||0.53|-8.31|0.0828
71010161|NCT04259749|141527245|OTHER||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.58|3.4|||||Adjusted for age, education, lifetime use of tobacco products.|||3.40|0.58|
71010162|NCT04259749|141527245|OTHER||Odds Ratio (OR)|2.28|||||TWO_SIDED|95.0|0.92|5.63|||||Adjusted for age, education, and lifetime use of tobacco products|||5.63|0.92|
71010163|NCT04259749|141527246|OTHER||Odds Ratio (OR)|1.58|||||TWO_SIDED|95.0|0.61|4.07|||||Adjusted for age, education, and lifetime use of tobacco products|||4.07|0.61|
71010164|NCT04259749|141527246|OTHER||Odds Ratio (OR)|3.45|||||TWO_SIDED|95.0|1.32|9.02|||||Adjusted for age, education, and lifetime use of tobacco products|||9.02|1.32|
71010165|NCT04259749|141527247|OTHER||Odds Ratio (OR)|1.48|||||TWO_SIDED|95.0|0.59|3.68|||||Adjusted for age, education, and lifetime use of tobacco|||3.68|.59|
70928524|NCT05622812|141352771|SUPERIORITY||Treatment difference|71.6|||<|0.001|TWO_SIDED|95.0|62.8|80.3||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 12||80.3|62.8|<0.001
71010166|NCT04259749|141527247|OTHER||Odds Ratio (OR)|2.6|||||TWO_SIDED|95.0|1.05|6.42|||||Adjusted for age, education, and lifetime use of tobacco products.|||6.42|1.05|
71010167|NCT04259749|141527248|OTHER||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.47|2.49|||||Adjusted for age, education, and lifetime use of tobacco|||2.49|.47|
71010168|NCT04259749|141527248|OTHER||Odds Ratio (OR)|1.43|||||TWO_SIDED|95.0|0.62|3.31|||||Adjusted for age, education, and lifetime use of tobacco products|||3.31|.62|
71103566|NCT02507934|141714866|SUPERIORITY||Mean Difference (Final Values)|-0.58||||0.7823|TWO_SIDED|95.0|-4.77|3.62||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Pain - Right eye||3.62|-4.77|0.7823
70928525|NCT02844465|141352776|NON_INFERIORITY|A non-inferiority test will be performed using a paired t-test, with a non-inferiority delta (δ) of one Reliable Change Index (RCI) of 5 points, to test the hypothesis of no reduction. A two-tailed alpha of 0.05 will be used.|||||<|0.0001|||||||Paired t-test|||"It is hypothesized that the Boston Naming Test score will not decrease from baseline to 12 months following the Visualase procedure. The hypotheses associated with this endpoint are as follows:~Null Hypothesis: μ (V-BNT - BSL-BNT) + δ ≤ 0 Alternate Hypothesis: μ (V-BNT - BSL-BNT) + δ \> 0 Where μ (V-BNT - BSL-BNT) = mean difference in the Boston Naming Test score from baseline to Month 12 post Visualase."||||<0.0001
71010169|NCT04259749|141527249|OTHER||Odds Ratio (OR)|1.73|||||TWO_SIDED|95.0|0.72|4.14|||||Adjusted for age, education, and lifetime use of tobacco products|||4.14|.72|
71010170|NCT04259749|141527249|OTHER||Odds Ratio (OR)|2.03|||||TWO_SIDED|95.0|0.83|4.95|||||Adjusted for age, education, and lifetime use of tobacco products.|||4.95|.83|
71010171|NCT04259749|141527250|OTHER||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.4|3.18|||||Adjusted for age, education, and lifetime tobacco use|||3.18|.40|
71010172|NCT04259749|141527250|OTHER||Odds Ratio (OR)|2.04|||||TWO_SIDED|95.0|0.73|5.71|||||Adjusted for age, education, and lifetime tobacco use|||5.71|.73|
71046379|NCT00518882|141601159|SUPERIORITY_OR_OTHER||Mean|-2.17|STANDARD_DEVIATION|3.654|<|0.0001||95.0|-2.731|-1.618|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-1.618|-2.731|<0.0001
71046380|NCT00518882|141601160|SUPERIORITY_OR_OTHER||Mean|-2.21|STANDARD_DEVIATION|3.752|<|0.0001||95.0|-2.747|-1.676|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-1.676|-2.747|<0.0001
71046381|NCT00518882|141601160|SUPERIORITY_OR_OTHER||Mean|-2.55|STANDARD_DEVIATION|3.625|<|0.0001||95.0|-3.104|-1.997|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-1.997|-3.104|<0.0001
71046382|NCT00518882|141601161|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|29.37|||<|0.0001||95.0|16.81|41.93||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||41.93|16.81|<.0001
71046383|NCT00518882|141601162|SUPERIORITY_OR_OTHER||Mean|-18.18|STANDARD_DEVIATION|62.811|<|0.0001||95.0|-26.988|-9.382|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||-9.382|-26.988|<0.0001
71046384|NCT00518882|141601162|SUPERIORITY_OR_OTHER||Mean|2.49|STANDARD_DEVIATION|52.997||0.5304||95.0|-5.327|10.307|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||10.307|-5.327|0.5304
71046385|NCT00518882|141601163|SUPERIORITY_OR_OTHER||Mean|24.86|STANDARD_DEVIATION|59.326|<|0.0001||95.0|16.348|33.374|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||33.374|16.348|<0.0001
71046386|NCT00518882|141601163|SUPERIORITY_OR_OTHER||Mean|11.13|STANDARD_DEVIATION|87.145||0.092||95.0|-1.835|24.093|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||24.093|-1.835|0.0920
71046387|NCT00518882|141601164|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.11||||0.0946||95.0|-0.23|0.02||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||0.02|-0.23|0.0946
71010173|NCT04259749|141527251|OTHER||Odds Ratio (OR)|1.77|||||TWO_SIDED|95.0|0.66|4.75|||||Adjusted for age, education, and lifetime tobacco use|||4.75|.66|
71010174|NCT04259749|141527251|OTHER||Odds Ratio (OR)|3.06|||||TWO_SIDED|95.0|1.13|8.29|||||Adjusted for age, education, and lifetime use of tobacco|||8.29|1.13|
71010175|NCT04259749|141527252|OTHER||Odds Ratio (OR)|1.38|||||TWO_SIDED|95.0|0.51|3.7|||||Adjusted for age, education, and lifetime tobacco use|||3.70|.51|
71010176|NCT04259749|141527252|OTHER||Odds Ratio (OR)|2.32|||||TWO_SIDED|95.0|0.85|6.31|||||Adjusted for age, education, and lifetime tobacco use|||6.31|.85|
71010177|NCT04259749|141527253|OTHER||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.29|4.26|||||Adjusted for age, education, and lifetime tobacco use|||4.26|.29|
71010178|NCT04259749|141527253|OTHER||Odds Ratio (OR)|2.0|||||TWO_SIDED|95.0|0.57|7.06|||||Adjusted for age, education, and lifetime tobacco use|||7.06|.57|
71010179|NCT04259749|141527254|OTHER||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.33|3.31|||||Adjusted for age, education, and lifetime tobacco use|||3.31|.33|
71103567|NCT02507934|141714866|SUPERIORITY||Mean Difference (Final Values)|4.93||||0.0432|TWO_SIDED|95.0|0.16|9.7||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Sticky feeling - Left eye||9.70|0.16|0.0432
71103568|NCT02507934|141714866|SUPERIORITY||Mean Difference (Final Values)|6.35||||0.0088|TWO_SIDED|95.0|1.7|11.0||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Sticky feeling - Right eye||11.00|1.70|0.0088
71010180|NCT04259749|141527254|OTHER||Odds Ratio (OR)|2.43|||||TWO_SIDED|0.95|0.83|7.13|||||Adjusted for age, education, and lifetime tobacco use|||7.13|.83|
71103569|NCT02507934|141714866|SUPERIORITY||Mean Difference (Final Values)|9.28||||0.0013|TWO_SIDED|95.0|3.9|14.66||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Blurred vision - Left eye||14.66|3.90|0.0013
71103570|NCT02507934|141714866|SUPERIORITY||Mean Difference (Final Values)|5.31||||0.00629|TWO_SIDED|95.0|-0.3|10.92||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Blurred vision - Right eye||10.92|-0.30|0.00629
71103571|NCT02507934|141714866|SUPERIORITY||Mean Difference (Final Values)|9.92||||0.002|TWO_SIDED|95.0|3.89|15.95||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Photophobia - Left eye||15.95|3.89|0.0020
71103572|NCT02507934|141714866|SUPERIORITY||Mean Difference (Final Values)|7.95||||0.0111|TWO_SIDED|95.0|1.93|13.97||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Photophobia - Right eye||13.97|1.93|0.0111
71103573|NCT02507934|141714866|SUPERIORITY||Mean Difference (Final Values)|31.67||||0.0448|TWO_SIDED|95.0|0.78|62.56||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Total score ocular tolerability - Left eye||62.56|0.78|0.0448
71103574|NCT02507934|141714866|SUPERIORITY||Mean Difference (Final Values)|26.36||||0.0834|TWO_SIDED|95.0|-3.66|56.37||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Total score ocular tolerability - Right eye||56.37|-3.66|0.0834
71010181|NCT04259749|141527255|OTHER||Odds Ratio (OR)|1.73|||||TWO_SIDED|95.0|0.72|4.14|||||Adjusted for age, education, and lifetime tobacco use|||4.14|.72|
71103575|NCT02507934|141714868|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.2317|TWO_SIDED|95.0|-0.14|0.57|||Student t-test for unpaired data|||T-test on changes from baseline on corneal fluorescein surface staining - Left eye - Day 7 ±1||0.57|-0.14|0.2317
71103576|NCT02507934|141714868|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.6017|TWO_SIDED|95.0|-0.7|0.41|||Student t-test for unpaired data|||T-test on changes from baseline on corneal fluorescein surface staining - Right eye - Day 7 ±1||0.41|-0.70|0.6017
71103577|NCT02507934|141714868|SUPERIORITY||Mean Difference (Final Values)|0.74||||0.0232|TWO_SIDED|95.0|0.11|1.36|||Student t-test for unpaired data|||T-test on changes from baseline on corneal fluorescein surface staining - Left eye - Day 14 ±1||1.36|0.11|0.0232
71103578|NCT02507934|141714868|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.0398|TWO_SIDED|95.0|0.03|1.17|||Student t-test for unpaired data|||T-test on changes from baseline on corneal fluorescein surface staining - Right eye - Day 14 ±1||1.17|0.03|0.0398
71010182|NCT04259749|141527255|OTHER||Odds Ratio (OR)|2.03|||||TWO_SIDED|95.0|0.83|4.95|||||Adjusted for age, education, and lifetime tobacco use|||4.95|.83|
71010183|NCT00303602|141527256|SUPERIORITY_OR_OTHER|||||||0.428||95.0||||P-value for Week 2 Change from Baseline. There was no adjustment for multiple comparisons.|Mixed Models Analysis|||||||0.428
71010184|NCT00303602|141527256|SUPERIORITY_OR_OTHER|||||||0.859||95.0||||P-value for Week 4 Change from Baseline. There was no adjustment for multiple comparisons.|Mixed Models Analysis|||||||0.859
71103579|NCT02507934|141714868|SUPERIORITY||Mean Difference (Final Values)|1.05||||0.0038|TWO_SIDED|95.0|0.36|1.74|||Student t-test for unpaired data|||T-test on changes from baseline on corneal fluorescein surface staining - Left eye - Day 21 ±1||1.74|0.36|0.0038
71103580|NCT02507934|141714868|SUPERIORITY||Mean Difference (Final Values)|0.75||||0.0135|TWO_SIDED|95.0|0.17|1.33|||Student t-test for unpaired data|||T-test on changes from baseline on corneal fluorescein surface staining - right eye||1.33|0.17|0.0135
71103581|NCT02507934|141714869|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.3442|TWO_SIDED|95.0|-0.66|1.83|||Student t-test for unpaired data|||T-test on changes from baseline on Schirmer's test type I strip wetting distance - Left eye - Day 7±1||1.83|-0.66|0.3442
71103582|NCT02507934|141714869|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.772|TWO_SIDED|95.0|-1.99|1.49|||Student t-test for unpaired data|||T-test on changes from baseline on Schirmer's test type I strip wetting distance - Right eye - Day 7±1||1.49|-1.99|0.7720
71103583|NCT02507934|141714869|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.9725|TWO_SIDED|95.0|-1.49|1.44|||Student t-test for unpaired data|||T-test on changes from baseline on Schirmer's test type I strip wetting distance - Left eye - Day 14±1||1.44|-1.49|0.9725
71103584|NCT02507934|141714869|SUPERIORITY||Mean Difference (Final Values)|-1.36||||0.2111|TWO_SIDED|95.0|-3.54|0.81|||Student t-test for unpaired data|||T-test on changes from baseline on Schirmer's test type I strip wetting distance - Right eye - Day 14±1||0.81|-3.54|0.2111
70928526|NCT02844465|141352777|NON_INFERIORITY|A non-inferiority test will be performed using a paired t-test, with a non-inferiority delta (δ) of one Reliable Change Index (RCI) of 15 points, to test the hypothesis of no reduction. A two-tailed alpha of 0.05 will be used.|||||<|0.0001|||||||Paired t-test|||"It is hypothesized that the Rey Auditory Verbal Learning Test 5-Trial Total score will not decrease from baseline to 12 months following the Visualase procedure. The hypotheses associated with this endpoint are as follows:~Null Hypothesis: μ (V-RAVLT - BSL-RAVLT) + δ ≤ 0 Alternate Hypothesis: μ (V-RAVLT - BSL-RAVLT) + δ \> 0 Where μ (V-RAVLT - BSL-RAVLT) = mean difference in the Rey Auditory Verbal Learning Test 5-Trial Total score from baseline to Month 12 post Visualase."||||<0.0001
70928527|NCT02844465|141352778|OTHER|A sign test will be used to determine if the median categorical change is significantly greater than zero.|||||<|0.0001|||||||Sign test|||"It is hypothesized that the QOLIE-31 score will increase (improve) from baseline to 12 months following the Visualase procedure. The hypotheses associated with this endpoint are as follows:~Null Hypothesis: M (V-QOLIE-31 - BSL-QOLIE-31) ≤ 0 Alternate Hypothesis: M (V-QOLIE-31 - BSL-QOLIE-31) \> 0 Where M (V-QOLIE-31 - BSL-QOLIE-31) = sign-test statistic (\[increases-decreases\]/2) in the Quality of Life in Epilepsy inventory from baseline to Month 12 post Visualase."||||<0.0001
70928528|NCT02844465|141352779|OTHER|A sign test will be used to determine if the median categorical change is significantly greater than zero.||||||0.0004|||||||Sign test|||"It is hypothesized that the SF-36 Mental Component Score (MCS) will increase (improve) from baseline to 12 months following the Visualase procedure. The hypotheses associated with this endpoint are as follows:~Null Hypothesis: M (V-SF-36 - BSL-SF-36-MCS) ≤ 0 Alternate Hypothesis: M (V-SF-36 - BSL-SF-36-MCS) \> 0 Where M (V- SF-36-MCS - BSL- SF-36-MCS) = sign-test statistic (\[increases-decreases\]/2) in the SF-36 quality of life questionnaire MCS from baseline to Month 12 post Visualase."||||0.0004
70928529|NCT02844465|141352780|OTHER|A sign test will be used to determine if the median categorical change is significantly greater than zero.|||||<|0.0001|||||||Sign test|||"It's hypothesized that the SF-36 Physical Component Score (PCS) will increase (improve) from baseline to 12 months following the Visualase procedure. The hypotheses associated with this endpoint are as follows:~Null Hypothesis: M (V-SF-36-PCS - BSL-SF-36-PCS) ≤ 0 Alternate Hypothesis: M (V-SF-36-PCS - BSL-SF-36-PCS) \> 0 Where M (V-SF-36-PCS - BSL- SF-36-PCS) = sign-test statistic (\[increases-decreases\]/2) in the SF-36 quality of life questionnaire PCS from baseline to Month 12 post Visualase."||||<0.0001
70928530|NCT02844465|141352781|NON_INFERIORITY|"The hypotheses associated with this endpoint are:~Null Hypothesis: π V - 64% + δ ≤ 0 Alternate Hypothesis: π V - 64% + δ \> 0 Where πV is the proportion of subjects treated with Visualase experiencing no seizures.~An exact 95% CI for the percentage of subjects who are seizure free will be calculated and its lower boundary compared to zero after subtraction of the historical open surgical resection percentage of 64% and the addition of the equivalence delta percentage of 10%."|Proportion of Participants|56.0|||||TWO_SIDED|95.0|46.2|65.8||||||||65.8|46.2|
70928531|NCT04228042|141352784|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
70928532|NCT04228042|141352784|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
70928533|NCT04228042|141352784|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71010185|NCT00303602|141527256|SUPERIORITY_OR_OTHER|||||||0.885||95.0||||P-value for Week 8 Change from Baseline. There was no adjustment for multiple comparisons.|Mixed Models Analysis|||||||0.885
70928534|NCT04228042|141352784|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
70928535|NCT03819153|141352785|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0001|TWO_SIDED|95.0|0.66|0.88|||Regression, Cox|||Time from randomization to first composite renal event was analyzed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by use of sodium glucose cotransporter-2 (SGLT-2) inhibitor (yes/no) at baseline. Based on the available number of events for analysis, the nominal significance level was updated to 0.01612 using the Lan-DeMets alpha spending function. eGFR was calculated using the CKD-EPI formula.||0.88|0.66|0.0001
70928536|NCT05452460|141352825|SUPERIORITY||Mean Difference (Final Values)|0.11|||>|0.05|TWO_SIDED||||||ANCOVA|ANCOVA with post-test condition difference in RT as the outcome, with Group as the factor, and pre-test condition difference in RT as the covariate.||||||> 0.05
70928537|NCT05452460|141352826|SUPERIORITY||Mean Difference (Final Values)|0.18|||>|0.05|TWO_SIDED||||||ANCOVA|ANCOVA with post-test condition difference in ACC the outcome, with Group as the factor, and pre-test condition difference in ACC as the covariate.||||||> .05
70928538|NCT05452460|141352827|SUPERIORITY||Mean Difference (Final Values)|0.32|||>|0.05|TWO_SIDED||||||ANCOVA|ANCOVA with post-test condition difference in N2 the outcome, with Group as the factor, and pre-test condition difference in N2 as the covariate.||||||> 0.05
70928539|NCT05452460|141352828|SUPERIORITY||Mean Difference (Final Values)|0.71|||>|0.05|TWO_SIDED||||||ANCOVA|ANCOVA with post-test condition difference in P3 the outcome, with Group as the factor, and pre-test condition difference in P3 as the covariate.||||||> 0.05
70928540|NCT05452460|141352829|SUPERIORITY||Mean Difference (Final Values)|13.35|||<|0.01|TWO_SIDED||||||ANCOVA|ANCOVA with post-test condition difference in TTE the outcome, with Group as the factor, and pre-test condition difference in TTE as the covariate.|\[F(1, 52) = 13.35, p = .001, ηp2 = .211\]|||||< 0.01
70928541|NCT05452460|141352830|SUPERIORITY||Mean Difference (Final Values)|0.02|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in VO2max Covariate: Pre-test condition difference in VO2max||||||> 0.05
70928542|NCT05452460|141352831|SUPERIORITY||Mean Difference (Final Values)|38.76|||<|0.01|TWO_SIDED||||||ANOVA|Four-way mixed-design ANOVA: 2 (GROUP) × 2 (CONDITION) × 3 (ASSESSMENT TIME) × 2 (Experiment Phase)||||||< 0.01
70928543|NCT05452460|141352832|SUPERIORITY||Mean Difference (Final Values)|9.21|||<|0.01|TWO_SIDED|||||The main effect of the Stroop block on accuracy showed a decrease from the first block to the fifth block.|ANOVA|Four-way mixed-design ANOVA: 2 (GROUP) × 2 (CONDITION) × 5 (BLOCK) × 2 (Phase)||||||< 0.01
71010186|NCT00303602|141527256|SUPERIORITY_OR_OTHER|||||||0.784||95.0||||P-value for Week 12 Change from Baseline. There was no adjustment for multiple comparisons.|Mixed Models Analysis|||||||0.784
71010187|NCT00303602|141527256|SUPERIORITY_OR_OTHER|||||||0.465||95.0||||P-value for Week 16 Change from Baseline. There was no adjustment for multiple comparisons|Mixed Models Analysis|||||||0.465
71010188|NCT00303602|141527257|SUPERIORITY_OR_OTHER||Least Square Mean Change Difference|-0.19||||0.442||95.0|-0.67|0.3|||ANCOVA||Change = Endpoint minus baseline|||0.30|-0.67|0.442
71010189|NCT00303602|141527258|SUPERIORITY_OR_OTHER||Least Square Mean Change Difference|-0.32||||0.328||95.0|-0.95|0.32|||ANCOVA||Change = Endpoint minus baseline|||0.32|-0.95|0.328
71046388|NCT00518882|141601165|SUPERIORITY_OR_OTHER||Mean|0.11|STANDARD_DEVIATION|0.774||0.0513||95.0|-0.001|0.216|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.216|-0.001|0.0513
71046389|NCT00518882|141601165|SUPERIORITY_OR_OTHER||Mean|0.12|STANDARD_DEVIATION|0.804||0.0513||95.0|-0.001|0.233|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.233|-0.001|0.0513
70928544|NCT05452460|141352833|SUPERIORITY||Mean Difference (Final Values)|7.07|||<|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test mean score Covariate: Pre-test mean score||||||< 0.05
70928545|NCT05452460|141352834|SUPERIORITY||Mean Difference (Final Values)|1.37|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in changed anger Covariate: Pre-test condition difference in changed anger||||||> 0.05
71010190|NCT00303602|141527259|SUPERIORITY_OR_OTHER|||||||0.385||95.0|||||Mixed Models Analysis|||||||0.385
71010191|NCT00303602|141527260|SUPERIORITY_OR_OTHER||Least Square Mean Change Difference|0.1||||0.914||95.0|-1.65|1.84|||ANCOVA||Change = endpoint minus baseline|||1.84|-1.65|0.914
71010192|NCT00303602|141527261|SUPERIORITY_OR_OTHER|||||||0.325||95.0||||Up to Week 16 p-value|Fisher Exact|||||||0.325
71010193|NCT00303602|141527263|SUPERIORITY_OR_OTHER|||||||0.344||95.0|||||Mixed Models Analysis|||||||0.344
71010194|NCT00303602|141527264|SUPERIORITY_OR_OTHER|||||||0.708||95.0||||Systolic Blood Pressure Change to Endpoint p-value|Rank-Sum Test|||||||0.708
71010195|NCT00303602|141527264|SUPERIORITY_OR_OTHER|||||||0.453||95.0||||Diastolic Blood Pressure Change to Endpoint p-value|Rank-Sum Test|||||||0.453
71010196|NCT00303602|141527265|SUPERIORITY_OR_OTHER|||||||0.187||95.0||||Total Cholesterol Change to Endpoint p-value|Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.187
71010197|NCT00303602|141527265|SUPERIORITY_OR_OTHER|||||||0.163||95.0||||High-Density Lipoprotein Cholesterol Change to Endpoint p-value|Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.163
71010198|NCT00303602|141527265|SUPERIORITY_OR_OTHER|||||||0.323||95.0||||Low-Density Lipoprotein Cholesterol Change to Endpoint p-value|Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.323
71046390|NCT00518882|141601166|SUPERIORITY_OR_OTHER||Mean|-0.07|STANDARD_DEVIATION|0.859||0.2764||95.0|-0.187|0.054|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.054|-0.187|0.2764
71046391|NCT00518882|141601166|SUPERIORITY_OR_OTHER||Mean|0.09|STANDARD_DEVIATION|0.89||0.1911||95.0|-0.043|0.216|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.216|-0.043|0.1911
71046392|NCT00518882|141601167|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.04||||0.4412||95.0|-0.15|0.06||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||0.06|-0.15|0.4412
70928546|NCT05452460|141352835|SUPERIORITY||Mean Difference (Final Values)|2.73|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in changed confusion Covariate: Pre-test condition difference in changed confusion||||||> 0.05
70928547|NCT05452460|141352836|SUPERIORITY||Mean Difference (Final Values)|0.07|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in changed depression Covariate: Pre-test condition difference in changed depression||||||> 0.05
71010199|NCT00303602|141527265|SUPERIORITY_OR_OTHER|||||||0.581||95.0||||Triglycerides Change to Endpoint p-value|Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.581
71010200|NCT00303602|141527266|SUPERIORITY_OR_OTHER|||||||0.227||95.0|||||Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.227
71010201|NCT00303602|141527267|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.020
71010202|NCT00303602|141527268|SUPERIORITY_OR_OTHER|||||||0.834||95.0|||||Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.834
71010203|NCT00303602|141527269|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals on this regression in CMH test.||||||0.022
71010204|NCT00303602|141527270|SUPERIORITY_OR_OTHER|||||||0.515||95.0||||Endpoint Metabolic Syndrome p-value|Fisher Exact|||||||0.515
71010205|NCT00303602|141527271|SUPERIORITY_OR_OTHER|||||||0.118||95.0|||||Mixed Models Analysis|||||||0.118
71010206|NCT00303602|141527272|SUPERIORITY_OR_OTHER|||||||0.161||95.0|||||Mixed Models Analysis|||||||0.161
71010207|NCT00303602|141527273|SUPERIORITY_OR_OTHER|||||||0.229||95.0|||||Mixed Models Analysis|||||||0.229
71010208|NCT03993314|141527275|SUPERIORITY|||||||0.757||||||Two-sided p-value|Farrington-Manning (Score) test|||Exact Farrington-Manning (Score) test of the null hypothesis that there is no difference between the proportion of patients achieving a level of numbness of T6 or higher between the two groups.||||0.757
70928548|NCT05452460|141352837|SUPERIORITY||Mean Difference (Final Values)|0.2|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in changed fatigue Covariate: Pre-test condition difference in changed fatigue||||||> 0.05
70928549|NCT05452460|141352838|SUPERIORITY||Mean Difference (Final Values)|0.01|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in changed confusion Covariate: Pre-test condition difference in changed confusion||||||> 0.05
70928550|NCT05452460|141352839|SUPERIORITY||Mean Difference (Final Values)|0.66|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in changed confusion Covariate: Pre-test condition difference in changed confusion||||||> 0.05
70928551|NCT04642820|141352849|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||.05
71010209|NCT03993314|141527276|SUPERIORITY|||||||0.186||||||Two-sided p-value|Wilcoxon (Mann-Whitney)|Test performed was an exact test; no continuity correction was used.||Exact Wilcoxon test of the null hypothesis that there is no difference between the median level of numbness between the two groups.||||0.186
71010210|NCT03993314|141527277|SUPERIORITY|||||||0.132||||||Two-sided p-value|Farrington-Manning (Score) test|||Exact Farrington-Manning (Score) test of the null hypothesis that there is no difference between the proportion of patients requiring epidural activation between the two groups.||||0.132
71046393|NCT00518882|141601168|SUPERIORITY_OR_OTHER||Mean|0.03|STANDARD_DEVIATION|0.606||0.4746||95.0|-0.054|0.115|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.115|-0.054|0.4746
71046394|NCT00518882|141601168|SUPERIORITY_OR_OTHER||Mean|0.08|STANDARD_DEVIATION|0.72||0.1281||95.0|-0.024|0.188|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.188|-0.024|0.1281
70928552|NCT05469464|141352850|SUPERIORITY||Mean Difference (Net)|-4.6|STANDARD_ERROR_OF_MEAN|6.93||0.505|TWO_SIDED|95.0|-18.2|9.0|||ANCOVA|||||9.0|-18.2|0.505
70928553|NCT05469464|141352850|SUPERIORITY||Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|7.15||0.812|TWO_SIDED|95.0|-15.8|12.3|||ANCOVA|||||12.3|-15.8|0.812
70928554|NCT05469464|141352850|SUPERIORITY||Mean Difference (Net)|-10.9|STANDARD_ERROR_OF_MEAN|6.99||0.118|TWO_SIDED|95.0|-24.6|2.8|||ANCOVA|||||2.8|-24.6|0.118
71046395|NCT00518882|141601169|SUPERIORITY_OR_OTHER||Mean|-0.3|STANDARD_DEVIATION|0.604|<|0.0001||95.0|-0.39|-0.214|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.214|-0.390|<0.0001
71046396|NCT00518882|141601169|SUPERIORITY_OR_OTHER||Mean|-0.21|STANDARD_DEVIATION|0.647|<|0.0001||95.0|-0.303|-0.11|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.110|-0.303|<0.0001
71046397|NCT00518882|141601170|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.07||||0.0277||95.0|-0.13|-0.01||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||-0.01|-0.13|0.0277
71046398|NCT00518882|141601171|SUPERIORITY_OR_OTHER||Mean|0.06|STANDARD_DEVIATION|0.29||0.003||95.0|0.021|0.102|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.102|0.021|0.0030
71046399|NCT00518882|141601171|SUPERIORITY_OR_OTHER||Mean|0.03|STANDARD_DEVIATION|0.307||0.1452||95.0|-0.012|0.079|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.079|-0.012|0.1452
71103585|NCT02507934|141714869|SUPERIORITY||Median Difference (Final Values)|-1.1||||0.2629|TWO_SIDED|90.0|-3.06|0.86|||Student t-test for unpaired data|||T-test on changes from baseline on Schirmer's test type I strip wetting distance - Left eye - Day 21±1||0.86|-3.06|0.2629
71103586|NCT02507934|141714869|SUPERIORITY||Mean Difference (Final Values)|-1.25||||0.2862|TWO_SIDED|95.0|-3.6|1.1|||Student t-test for unpaired data|||T-test on changes from baseline on Schirmer's test type I strip wetting distance - Right eye - 21±1||1.10|-3.60|0.2862
71103587|NCT02507934|141714870|SUPERIORITY||Mean Difference (Final Values)|11.24||||0.2075|TWO_SIDED|95.0|-6.66|29.14|||Student t-test for unpaired data|||T-test on changes from baseline in symptom assessment in dry eye - Frequency - Day 7±1||29.14|-6.66|0.2075
71103588|NCT02507934|141714870|SUPERIORITY||Mean Difference (Final Values)|18.16||||0.0435|TWO_SIDED|95.0|0.57|35.76|||Student t-test for unpaired data|||T-test on changes from baseline in symptom assessment in dry eye - Frequency - Day 14±1||35.76|0.57|0.0435
70928555|NCT01208662|141352896|SUPERIORITY||Hazard Ratio (HR)|1.53|||<|0.001|TWO_SIDED|95.0|1.23|1.91|||Log Rank|Observed Stratified Log Rank Test (1-sided p-value)||||1.91|1.23|<0.001
70928556|NCT01208662|141352897|SUPERIORITY|||||||0.55|||||||Fisher Exact|||Exact (Clopper-Pearson) confidence limits of 98.2857% represents Bonferroni adjustment for 7 tests (1-0.05/7) per statistical analysis plan for key secondary outcomes.||||0.55
70928557|NCT01208662|141352898|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Exact (Clopper-Pearson) confidence limits of 98.2857% represents Bonferroni adjustment for 7 tests (1-0.05/7) per statistical analysis plan for key secondary outcomes.||||0.99
70928558|NCT01208662|141352899|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Exact (Clopper-Pearson) confidence limits of 98.2857% represents Bonferroni adjustment for 7 tests (1-0.05/7) per statistical analysis plan for key secondary outcomes.||||0.99
71010211|NCT03993314|141527278|SUPERIORITY|||||||0.833||||||Two-sided p-value|Farrington-Manning (Score) test|||Exact Farrington-Manning (Score) test of the null hypothesis that there is no difference between the proportion of patients requiring supplemental IV sedation or general anesthesia between the two groups.||||0.833
71010212|NCT03993314|141527279|SUPERIORITY|||||||0.004||||||Two-sided p-value|Wilcoxon (Mann-Whitney)|Test performed was an exact test; no continuity correction was used.||Exact Wilcoxon test of the null hypothesis that there is no difference between the median modified Bromage score between the two groups.||||0.004
71010213|NCT03993314|141527280|SUPERIORITY|||||||0.674||||||Two-sided p-value|Wilcoxon (Mann-Whitney)|Test performed was an exact test; no continuity correction was used.||Exact Wilcoxon test of the null hypothesis that there is no difference between the median modified Bromage score between the two groups.||||0.674
71010214|NCT03993314|141527281|SUPERIORITY|||||||0.196|||||||Log Rank|||Log-rank test of the null hypothesis that there is no difference in the time to discharge from the Post Anesthesia Care Unit (PACU) between the two groups.||||0.196
71010215|NCT03938857|141527406|OTHER||Slope|-0.1088295|STANDARD_ERROR_OF_MEAN|0.4728041||0.814|TWO_SIDED|95.0|-1.035508|0.8178494|||Mixed Models Analysis||Estimated value represents interaction between treatment and days.|Placebo group compared to combined Dexmedetomidine groups.||0.8178494|-1.035508|0.814
71010216|NCT02516605|141527434|OTHER||adjusted fold change from baseline|0.86||||0.293|TWO_SIDED|90.0|0.68|1.09|||ANCOVA|||||1.09|0.68|0.293
71010217|NCT02516605|141527434|OTHER||adjusted fold change from baseline|0.47|||<|0.001|TWO_SIDED|90.0|0.37|0.6|||ANCOVA|||||0.60|0.37|<0.001
71010218|NCT02516605|141527434|OTHER||adjusted fold change from baseline|0.32|||<|0.001|TWO_SIDED|90.0|0.26|0.4|||ANCOVA|||||0.40|0.26|<.001
71010219|NCT02516605|141527434|OTHER||adjusted fold change from baseline|0.36|||<|0.001|TWO_SIDED|90.0|0.27|0.47|||ANCOVA|||||0.47|0.27|<.001
71010220|NCT02516605|141527444|OTHER||Median difference from baseline|1.0||||0.898|TWO_SIDED|90.0|-7.0|6.0|||Wilcoxon rank-sum test|Day 28||||6.0|-7.0|0.898
71010221|NCT02516605|141527444|OTHER||Median difference from baseline|2.0||||0.593|TWO_SIDED|90.0|-4.0|10.0|||Wilcoxon rank-sum test|Day 56||||10.0|-4.0|0.593
71010222|NCT02516605|141527444|OTHER||Median difference from baseline|-3.0||||0.509|TWO_SIDED|90.0|-11.0|4.0|||Wilcoxon rank-sum test|Day 84||||4.0|-11.0|0.509
71010223|NCT02516605|141527444|OTHER||Median difference from baseline|1.5||||0.591|TWO_SIDED|90.0|-5.0|7.0|||Wilcoxon rank-sum test|Day 28||||7.0|-5.0|0.591
71010224|NCT02516605|141527444|OTHER||Median difference from baseline|-2.0||||0.702|TWO_SIDED|90.0|-12.0|4.0|||Wilcoxon rank-sum test|Day 56||||4.0|-12.0|0.702
71010225|NCT02516605|141527444|OTHER||Median difference from baseline|-1.0||||0.838|TWO_SIDED|90.0|-10.0|8.0|||Wilcoxon rank-sum test|Day 84||||8.0|-10.0|0.838
71010226|NCT02516605|141527444|OTHER||Median difference from baseline|4.0||||0.297|TWO_SIDED|90.0|-3.0|8.0|||Wilcoxon rank-sum test|Day 28||||8.0|-3.0|0.297
71010227|NCT02516605|141527444|OTHER||Median difference from baseline|-6.0||||0.236|TWO_SIDED|90.0|-14.0|1.0|||Wilcoxon rank-sum test|Day 56||||1.0|-14.0|0.236
71010228|NCT02516605|141527444|OTHER||Median difference from baseline|-6.5||||0.192|TWO_SIDED|90.0|-15.0|1.0|||Wilcoxon rank-sum test|Day 84||||1.0|-15.0|0.192
71010229|NCT02516605|141527444|OTHER||Median difference from baseline|2.0||||0.605|TWO_SIDED|90.0|-2.0|9.0|||Wilcoxon rank-sum test|Day 28||||9.0|-2.0|0.605
71010230|NCT02516605|141527444|OTHER||Median difference from baseline|-11.0||||0.037|TWO_SIDED|90.0|-21.0|-1.0|||Wilcoxon rank-sum test|Day 56||||-1.0|-21.0|0.037
71010231|NCT02516605|141527444|OTHER||Median difference from baseline|-3.5||||0.397|TWO_SIDED|90.0|-11.0|3.0|||Wilcoxon rank-sum test|Day 84||||3.0|-11.0|0.397
71010232|NCT02516605|141527445|OTHER||Median difference from baseline|1.0||||0.342|TWO_SIDED|90.0|-1.0|2.0|||Wilcoxon rank-sum test|Day 28||||2.0|-1.0|0.342
71010233|NCT02516605|141527445|OTHER||Median difference from baseline|0.0||||0.699|TWO_SIDED|90.0|-1.0|2.0|||Wilcoxon rank-sum test|Day 56||||2.0|-1.0|0.699
71010234|NCT02516605|141527445|OTHER||Median difference from baseline|-1.0||||0.377|TWO_SIDED|90.0|-3.0|0.0|||Wilcoxon rank-sum test|Day 84||||0.0|-3.0|0.377
71010235|NCT02516605|141527445|OTHER||Median difference from baseline|1.0||||0.132|TWO_SIDED|90.0|0.0|2.0|||Wilcoxon rank-sum test|Day 28||||2.0|0.0|0.132
71010236|NCT02516605|141527445|OTHER||Median difference from baseline|1.0||||0.292|TWO_SIDED|90.0|0.0|2.0|||Wilcoxon rank-sum test|Day 56||||2.0|0.0|0.292
71010237|NCT02516605|141527445|OTHER||Median difference from baseline|0.0||||0.979|TWO_SIDED|90.0|-2.0|1.0|||Wilcoxon rank-sum test|Day 84||||1.0|-2.0|0.979
71010238|NCT02516605|141527445|OTHER||Median difference from baseline|2.0||||0.102|TWO_SIDED|90.0|0.0|4.0|||Wilcoxon rank-sum test|Day 28||||4.0|0.0|0.102
71010239|NCT02516605|141527445|OTHER||Median difference from baseline|0.0||||0.717|TWO_SIDED|90.0|-1.0|2.0|||Wilcoxon rank-sum test|Day 56||||2.0|-1.0|0.717
71010240|NCT02516605|141527445|OTHER||Median difference|0.0||||1|TWO_SIDED|90.0|-2.0|1.0|||Wilcoxon rank-sum test|Day 84||||1.0|-2.0|1.000
71010241|NCT02516605|141527445|OTHER||Median difference from baseline|2.0||||0.142|TWO_SIDED|90.0|0.0|5.0|||Wilcoxon rank-sum test|Day 28||||5.0|0.0|0.142
71010242|NCT02516605|141527445|OTHER||Median difference from baseline|0.0||||0.975|TWO_SIDED|90.0|-1.0|1.0|||Wilcoxon rank-sum test|Day 56||||1.0|-1.0|0.975
71010243|NCT02516605|141527445|OTHER||Median difference from baseline|0.0||||0.602|TWO_SIDED|90.0|-2.0|1.0|||Wilcoxon rank-sum test|Day 84||||1.0|-2.0|0.602
71010244|NCT02516605|141527446|OTHER||Mean difference from baseline|-2.78|STANDARD_ERROR_OF_MEAN|8.436||0.743|TWO_SIDED|90.0|-16.91|11.34|||ANCOVA|Day 7||||11.34|-16.91|0.743
71010245|NCT02516605|141527446|OTHER||Median difference from baseline|-14.07|STANDARD_ERROR_OF_MEAN|8.229||0.093|TWO_SIDED|90.0|-27.85|-0.28|||ANCOVA|Day 14||||-0.28|-27.85|0.093
71010246|NCT02516605|141527446|OTHER||Median difference from baseline|7.78|STANDARD_ERROR_OF_MEAN|8.71||0.376|TWO_SIDED|90.0|-6.81|22.38|||ANCOVA|Day 21||||22.38|-6.81|0.376
71010247|NCT02516605|141527446|OTHER||Median difference from baseline|7.03|STANDARD_ERROR_OF_MEAN|9.187||0.448|TWO_SIDED|90.0|-8.36|22.43|||ANCOVA|Day 28||||22.43|-8.36|0.448
71010248|NCT02516605|141527446|OTHER||Median difference from baseline|-15.25|STANDARD_ERROR_OF_MEAN|7.192||0.039|TWO_SIDED|90.0|-27.3|-3.19|||ANCOVA|Day 56||||-3.19|-27.30|0.039
71010249|NCT02516605|141527446|OTHER||Median difference from baseline|-16.93|STANDARD_ERROR_OF_MEAN|8.592||0.054|TWO_SIDED|90.0|-31.31|-2.54|||ANCOVA|Day 84||||-2.54|-31.31|0.054
71010250|NCT02516605|141527446|OTHER||Median difference from baseline|11.34|STANDARD_ERROR_OF_MEAN|8.434||0.185|TWO_SIDED|90.0|-2.78|25.46|||ANCOVA|Day 7||||25.46|-2.78|0.185
71046400|NCT00518882|141601172|SUPERIORITY_OR_OTHER||Mean|0.27|STANDARD_DEVIATION|0.306|<|0.0001||95.0|0.223|0.315|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.315|0.223|<0.0001
71010251|NCT02516605|141527446|OTHER||Median difference from baseline|7.74|STANDARD_ERROR_OF_MEAN|8.226||0.351|TWO_SIDED|90.0|-6.05|21.52|||ANCOVA|Day 14||||21.52|-6.05|0.351
71046401|NCT00518882|141601172|SUPERIORITY_OR_OTHER||Mean|0.31|STANDARD_DEVIATION|0.346|<|0.0001||95.0|0.259|0.364|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.364|0.259|<0.0001
71046402|NCT00518882|141601173|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.01||||0.5105||95.0|-0.02|0.04||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||0.04|-0.02|0.5105
71010252|NCT02516605|141527446|OTHER||Median difference from baseline|16.79|STANDARD_ERROR_OF_MEAN|8.707||0.059|TWO_SIDED|90.0|2.2|31.38|||ANCOVA|day 21||||31.38|2.20|0.059
71010253|NCT02516605|141527446|OTHER||Median difference from baseline|14.05|STANDARD_ERROR_OF_MEAN|9.184||0.132|TWO_SIDED|90.0|-1.35|29.44|||ANCOVA|Day 28||||29.44|-1.35|0.132
71010254|NCT02516605|141527446|OTHER||Median difference from baseline|-1.75|STANDARD_ERROR_OF_MEAN|7.19||0.809|TWO_SIDED|90.0|-13.8|10.31|||ANCOVA|Day 56||||10.31|-13.80|0.809
71010255|NCT02516605|141527446|OTHER||Median difference from baseline|-10.9|STANDARD_ERROR_OF_MEAN|8.59||0.21|TWO_SIDED|90.0|-25.29|3.48|||ANCOVA|Day 84||||3.48|-25.29|0.210
71010256|NCT02516605|141527446|OTHER||Median difference from baseline|13.92|STANDARD_ERROR_OF_MEAN|7.963||0.086||90.0|0.58|27.25|||ANCOVA|day 7||||27.25|0.58|0.086
71010257|NCT02516605|141527446|OTHER||Median difference from baseline|0.48|STANDARD_ERROR_OF_MEAN|7.787||0.951|TWO_SIDED|90.0|-12.57|13.53|||ANCOVA|Day 14||||13.53|-12.57|0.951
71046403|NCT00518882|141601174|SUPERIORITY_OR_OTHER||Mean|-0.01|STANDARD_DEVIATION|0.15||0.222||95.0|-0.034|0.008|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.008|-0.034|0.2220
71010258|NCT02516605|141527446|OTHER||Median difference from baseline|5.02|STANDARD_ERROR_OF_MEAN|8.244||0.545|TWO_SIDED|90.0|-8.79|18.83|||ANCOVA|day 21||||18.83|-8.79|0.545
71046404|NCT00518882|141601174|SUPERIORITY_OR_OTHER||Mean|0.0|STANDARD_DEVIATION|0.141||0.7923||95.0|-0.018|0.024|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.024|-0.018|0.7923
71046405|NCT00518882|141601175|SUPERIORITY_OR_OTHER||Mean|-0.03|STANDARD_DEVIATION|0.159||0.0254||95.0|-0.05|-0.003|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.003|-0.050|0.0254
71046406|NCT00518882|141601175|SUPERIORITY_OR_OTHER||Mean|-0.02|STANDARD_DEVIATION|0.165||0.2244||95.0|-0.04|0.009|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.009|-0.040|0.2244
71077847|NCT02913105|141664396|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.99||||0.6329|TWO_SIDED|90.0|0.97|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||1.02|0.97|0.6329
71010259|NCT02516605|141527446|OTHER||Median difference from baseline|0.19|STANDARD_ERROR_OF_MEAN|8.697||0.982|TWO_SIDED|90.0|-14.38|14.77|||ANCOVA|Day 28||||14.77|-14.38|0.982
71010260|NCT02516605|141527446|OTHER||Median difference from baseline|-13.82|STANDARD_ERROR_OF_MEAN|6.797||0.047|TWO_SIDED|90.0|-25.21|-2.43|||ANCOVA|day 56||||-2.43|-25.21|0.047
71010261|NCT02516605|141527446|OTHER||Median difference from baseline|-18.23|STANDARD_ERROR_OF_MEAN|8.11||0.029|TWO_SIDED|90.0|-31.81|-4.64|||ANCOVA|Day 84||||-4.64|-31.81|0.029
71010262|NCT02516605|141527446|OTHER||Median difference from baseline|26.7|STANDARD_ERROR_OF_MEAN|8.799||0.004|TWO_SIDED|90.0|11.97|41.44|||ANCOVA|Day 7||||41.44|11.97|0.004
71010263|NCT02516605|141527446|OTHER||Median difference from baseline|8.17|STANDARD_ERROR_OF_MEAN|9.032||0.37|TWO_SIDED|90.0|-6.96|23.29|||ANCOVA|Day 14||||23.29|-6.96|0.370
71010264|NCT02516605|141527446|OTHER||Median difference from baseline|5.9|STANDARD_ERROR_OF_MEAN|10.014||0.558|TWO_SIDED|90.0|-10.86|22.66|||ANCOVA|Day 21||||22.66|-10.86|0.558
71010265|NCT02516605|141527446|OTHER||Median difference from baseline|8.91|STANDARD_ERROR_OF_MEAN|10.911||0.418|TWO_SIDED|90.0|-9.34|27.15|||ANCOVA|Day 28||||27.15|-9.34|0.418
71010266|NCT02516605|141527446|OTHER||Median difference from baseline|-11.08|STANDARD_ERROR_OF_MEAN|7.69||0.156|TWO_SIDED|90.0|-23.95|1.8|||ANCOVA|Day 56||||1.80|-23.95|0.156
71010267|NCT02516605|141527446|OTHER||Median difference from baseline|-16.93|STANDARD_ERROR_OF_MEAN|8.961||0.064|TWO_SIDED|90.0|-31.94|-1.92|||ANCOVA|Day 84||||-1.92|-31.94|0.064
71010268|NCT02577107|141527447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.314|STANDARD_ERROR_OF_MEAN|4.1613|||TWO_SIDED|95.0|9.618|31.011||||||||31.011|9.618|
71010269|NCT02839330|141527455|EQUIVALENCE|Equivalence margin: The 2-sided 95% confidence interval (CI) of all the 3 pairwise comparisons of GMTs to fall between the predefined equivalence ranges of 0.667 and 1.5|GMT ratio|1.01|||||TWO_SIDED|95.0|0.9|1.13||||||aH5N1c Lot #1 vs. aH5N1c Lot #2||1.13|0.90|
71010270|NCT02839330|141527455|EQUIVALENCE|Equivalence margin: The 2-sided 95% CIs of all the 3 pairwise comparisons of GMTs to fall between the predefined equivalence ranges of 0.667 and 1.5|GMT ratio|0.96|||||TWO_SIDED|95.0|0.86|1.08||||||aH5N1c Lot #2 vs. aH5N1c Lot #3||1.08|0.86|
71010271|NCT02839330|141527455|EQUIVALENCE|Equivalence margin: The 2-sided 95% CIs of all the 3 pairwise comparisons of GMTs to fall between the predefined equivalence ranges of 0.667 and 1.5|GMT ratio|0.97|||||TWO_SIDED|95.0|0.87|1.09||||||aH5N1c Lot #1 vs. aH5N1c Lot #3||1.09|0.87|
71010272|NCT03802331|141527469|OTHER|Relative bioavailability|Adjusted Geometric Mean Ratio T/R (%)|166.02|||||TWO_SIDED|90.0|143.17|192.53|||||The Adjusted Geometric Mean is adjusted by treatment. Geometric coefficient of variation (gCV) = 19.0.|This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period, and treatment.||192.53|143.17|
71010273|NCT03802331|141527470|OTHER|Relative bioavailability|Ajusted Geometric Mean Ratio T/R (%)|235.5|||||TWO_SIDED|90.0|179.82|308.42|||||The Adjusted Geometric Mean is adjusted by treatment. Geometric coefficient of variation (gCV) = 35.4.|This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period, and treatment.||308.42|179.82|
71010274|NCT03802331|141527471|OTHER|Relative bioavailability|Adjusted Geometric Mean Ratio T/R (%)|159.39|||||TWO_SIDED|90.0|140.11|181.34|||||The Adjusted Geometric Mean is adjusted by treatment. Geometric coefficient of variation (gCV) = 16.5.|This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period, and treatment.||181.34|140.11|
71010275|NCT04051320|141527486|SUPERIORITY||F statistic|2.164||||0.16|TWO_SIDED||||||repeated measures ANOVA|||||||0.160
71010276|NCT04051320|141527487|SUPERIORITY||F statistic|1.74||||0.1922|TWO_SIDED||||||ANOVA|||||||0.1922
71010277|NCT04051320|141527488|SUPERIORITY||F statistic|0.837||||0.368|TWO_SIDED||||||ANOVA|||||||0.368
71010278|NCT04051320|141527489|SUPERIORITY||F statistic|0.23||||0.881|TWO_SIDED||||||ANOVA|||||||0.881
71010279|NCT04051320|141527490|SUPERIORITY||F statistic|16.541||||0.000723|TWO_SIDED||||||ANOVA|||||||0.000723
71010280|NCT04051320|141527491|SUPERIORITY||F statistic|0.072||||0.791|TWO_SIDED||||||ANOVA|||||||0.791
71010281|NCT04051320|141527492|SUPERIORITY||F statistic|4.952||||0.0372|TWO_SIDED||||||ANOVA|||||||0.0372
71010282|NCT04051320|141527493|SUPERIORITY||F statistic|3.258||||0.0861|TWO_SIDED||||||ANOVA|||||||0.0861
71010283|NCT04051320|141527494|SUPERIORITY||F statistic|2.37||||0.139|TWO_SIDED||||||ANOVA|||||||0.139
71010284|NCT04051320|141527495|SUPERIORITY||F statistic|1.484||||0.237|TWO_SIDED||||||ANOVA|||||||0.237
71010285|NCT04051320|141527496|SUPERIORITY||F statistic|0.013||||0.91|TWO_SIDED||||||ANOVA|||||||0.910
71010286|NCT04051320|141527497|SUPERIORITY||F statistic|4.609||||0.0449|TWO_SIDED||||||ANOVA|||||||0.0449
71010287|NCT04051320|141527498|SUPERIORITY|||||||0.322|||||||Pearson's Correlation Coefficient|||||||0.322
71010288|NCT04051320|141527498|SUPERIORITY|||||||0.772|||||||Pearson's Correlation Coefficient|||||||0.772
71010289|NCT04051320|141527499|SUPERIORITY||Pearson's r|-0.568314||||0.068|TWO_SIDED||||||Pearson correlation|||||||0.068
71010290|NCT04051320|141527499|SUPERIORITY||Pearson's r|-0.082904||||0.8759289|TWO_SIDED||||||Pearson correlation|||||||0.8759289
71010291|NCT04051320|141527500|SUPERIORITY||Pearson's r|-0.1275539||||0.70859639|TWO_SIDED||||||Pearson correlation|||||||0.70859639
71010292|NCT04051320|141527500|SUPERIORITY||Pearson's r|0.49225646||||0.2617744|TWO_SIDED||||||Pearson correlation|||||||0.2617744
71010293|NCT04051320|141527501|SUPERIORITY|||||||0.568|||||||Pearson's Correlation Coefficient|||||||0.568
71010294|NCT04051320|141527501|SUPERIORITY|||||||0.944|||||||Pearson's Correlation Coefficient|||||||0.944
71010295|NCT04051320|141527502|SUPERIORITY|||||||0.103|||||||Pearson's Correlation Coefficient|||||||0.103
71010296|NCT01632345|141527503|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|6.7|||||TWO_SIDED|95.0|-9.0|22.4|||||A negative value would be considered as favoring doravirine over efavirenz.|||22.4|-9.0|
71010297|NCT01632345|141527503|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|9.7|||||TWO_SIDED|95.0|-4.6|24.9|||||A negative value would be considered as favoring doravirine over efavirenz.|||24.9|-4.6|
71010298|NCT01632345|141527503|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|-11.9|||||TWO_SIDED|95.0|-27.9|6.3|||||A negative value would be considered as favoring doravirine over efavirenz.|||6.3|-27.9|
71010299|NCT01632345|141527503|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|2.0|||||TWO_SIDED|95.0|-14.5|18.4|||||A negative value would be considered as favoring doravirine over efavirenz.|||18.4|-14.5|
71010300|NCT01632345|141527504|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|-2.3|||||TWO_SIDED|95.0|-13.7|8.8|||||A negative value would be considered as favoring doravirine over efavirenz.|||8.8|-13.7|
71010301|NCT01632345|141527504|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|2.2|||||TWO_SIDED|95.0|-9.9|14.7|||||A negative value would be considered as favoring doravirine over efavirenz.|||14.7|-9.9|
71010302|NCT01632345|141527504|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|-2.4|||||TWO_SIDED|95.0|-13.8|8.2|||||A negative value would be considered as favoring doravirine over efavirenz.|||8.2|-13.8|
71010303|NCT01632345|141527504|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|-4.8|||||TWO_SIDED|95.0|-15.9|4.1|||||A negative value would be considered as favoring doravirine over efavirenz.|||4.1|-15.9|
71010304|NCT01632345|141527505|SUPERIORITY_OR_OTHER||Difference|-10.2|||||TWO_SIDED|95.0|-20.9|0.5|||||A negative value would be considered as favoring doravirine over efavirenz.|||0.5|-20.9|
71010305|NCT01632345|141527506|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|-20.4||||0.002|TWO_SIDED|95.0|-32.4|-7.8||Superiority analysis|Miettinen and Nurminen method||A negative value would be considered as favoring doravirine over efavirenz.|||-7.8|-32.4|0.002
71010306|NCT01632345|141527507|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|-20.4||||0.002|TWO_SIDED|95.0|-32.6|-7.5||Superiority analysis|Miettinen and Nurminen method||A negative value would be considered as favoring doravirine over efavirenz.|||-7.5|-32.6|0.002
71010307|NCT01632345|141527508|SUPERIORITY_OR_OTHER||Difference in % response|15.7|||||TWO_SIDED|95.0|-4.1|34.4|||||A positive value would be considered as favoring doravirine over efavirenz.|||34.4|-4.1|
70928559|NCT01208662|141352901|SUPERIORITY||Hazard Ratio (HR)|1.66|||<|0.001|TWO_SIDED|99.29|1.21|2.27|||Log Rank|Stratified||Exact (Clopper-Pearson) confidence limits of 98.2857% represents Bonferroni adjustment for 7 tests (1-0.05/7) per statistical analysis plan for key secondary outcomes.||2.27|1.21|<0.001
70928560|NCT01208662|141352902|SUPERIORITY||Hazard Ratio (HR)|1.1|||>|0.99|TWO_SIDED|95.0|0.73|1.65|||Log Rank|||||1.65|0.73|>0.99
71046407|NCT00518882|141601176|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.18||||0.0485||95.0|-0.37|0.0||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||-0.00|-0.37|0.0485
70928561|NCT01208662|141352904|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.99|TWO_SIDED|99.29|0.73|1.65|||Log Rank|Stratified||Exact (Clopper-Pearson) confidence limits of 98.2857% represents Bonferroni adjustment for 7 tests (1-0.05/7) per statistical analysis plan for key secondary outcomes.||1.65|0.73|0.99
71010308|NCT01632345|141527508|SUPERIORITY_OR_OTHER||Difference in % response|10.0|||||TWO_SIDED|95.0|-9.6|29.1|||||A positive value would be considered as favoring doravirine over efavirenz.|||29.1|-9.6|
71010309|NCT01632345|141527508|SUPERIORITY_OR_OTHER||Difference in % response|6.6|||||TWO_SIDED|95.0|-13.2|26.0|||||A positive value would be considered as favoring doravirine over efavirenz.|||26.0|-13.2|
71010310|NCT01632345|141527508|SUPERIORITY_OR_OTHER||Difference in % response|15.9|||||TWO_SIDED|95.0|-3.4|34.4|||||A positive value would be considered as favoring doravirine over efavirenz.|||34.4|-3.4|
71010311|NCT01632345|141527509|SUPERIORITY_OR_OTHER||Difference in % response|-0.5|||||TWO_SIDED|95.0|-13.2|11.2|||||A positive value would be considered as favoring doravirine over efavirenz.|||11.2|-13.2|
71010312|NCT01632345|141527510|SUPERIORITY_OR_OTHER||Difference in % response|-1.9|||||TWO_SIDED|95.0|-12.9|9.2|||||A positive value would be considered as favoring doravirine over efavirenz.|||9.2|-12.9|
71010313|NCT01632345|141527511|SUPERIORITY_OR_OTHER||Difference in % response|-0.8|||||TWO_SIDED|95.0|-12.4|10.7|||||A positive value would be considered as favoring doravirine over efavirenz.|||10.7|-12.4|
71010314|NCT01632345|141527512|SUPERIORITY_OR_OTHER||Difference in % response|4.5|||||TWO_SIDED|95.0|-12.5|21.5|||||A positive value would be considered as favoring doravirine over efavirenz.|||21.5|-12.5|
71046408|NCT00518882|141601177|SUPERIORITY_OR_OTHER||Mean|0.1|STANDARD_DEVIATION|0.82||0.1161||95.0|-0.02|0.21|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.21|-0.02|0.1161
71103589|NCT02507934|141714870|SUPERIORITY||Mean Difference (Final Values)|23.58||||0.0133|TWO_SIDED|95.0|5.24|41.93|||Student t-test for unpaired data|||T-test on changes from baseline in symptom assessment in dry eye - Frequency - Day 21±1||41.93|5.24|0.0133
71010315|NCT01632345|141527512|SUPERIORITY_OR_OTHER||Difference in % response|2.8|||||TWO_SIDED|95.0|-13.9|19.8|||||A positive value would be considered as favoring doravirine over efavirenz.|||19.8|-13.9|
71010316|NCT01632345|141527512|SUPERIORITY_OR_OTHER||Difference in % response|12.2|||||TWO_SIDED|95.0|-2.5|28.0|||||A positive value would be considered as favoring doravirine over efavirenz.|||28.0|-2.5|
71103590|NCT02507934|141714871|SUPERIORITY||Mean Difference (Final Values)|4.36||||0.613|TWO_SIDED|95.0|-12.98|21.69|||Student t-test for unpaired data|||T-test on changes from baseline in symptom assessment in dry eye - Severity - Day 7±1||21.69|-12.98|0.6130
70928562|NCT01208662|141352911|SUPERIORITY||Odds Ratio (OR)|0.55|||||TWO_SIDED|95.0|0.3|1.01||||||||1.01|0.30|
70928563|NCT06473662|141352926|OTHER||Mean Difference (Final Values)|-0.53||||0.0039|TWO_SIDED||||||t-test, 2 sided|||||||0.0039
71010317|NCT01632345|141527512|SUPERIORITY_OR_OTHER||Difference in % response|9.5|||||TWO_SIDED|95.0|-6.2|25.7|||||A positive value would be considered as favoring doravirine over efavirenz.|||25.7|-6.2|
71010318|NCT01632345|141527513|SUPERIORITY_OR_OTHER||Difference in % response|2.7||||||95.0|-6.1|11.7|||||A positive value would be considered as favoring doravirine over efavirenz.|||11.7|-6.1|
71010319|NCT01632345|141527514|SUPERIORITY_OR_OTHER||Difference in % response|0.1|||||TWO_SIDED|95.0|-9.7|9.9|||||A positive value would be considered as favoring doravirine over efavirenz.|||9.9|-9.7|
71010320|NCT01632345|141527515|SUPERIORITY_OR_OTHER||Difference in % response|3.9|||||TWO_SIDED|95.0|-7.3|15.0|||||A positive value would be considered as favoring doravirine over efavirenz.|||15.0|-7.3|
71010321|NCT01632345|141527516|SUPERIORITY_OR_OTHER||Difference in CD4 change|33.0|||||TWO_SIDED|95.0|-28.1|94.0|||||A positive value would be considered as favoring doravirine over efavirenz.|||94.0|-28.1|
71010322|NCT01632345|141527516|SUPERIORITY_OR_OTHER||Difference in CD4 change|-8.3|||||TWO_SIDED|95.0|-68.5|51.9|||||A positive value would be considered as favoring doravirine over efavirenz.|||51.9|-68.5|
71010323|NCT01632345|141527516|SUPERIORITY_OR_OTHER||Difference in CD4 change|12.5|||||TWO_SIDED|95.0|-44.6|69.5|||||A positive value would be considered as favoring doravirine over efavirenz.|||69.5|-44.6|
71010324|NCT01632345|141527516|SUPERIORITY_OR_OTHER||Difference in CD4 change|19.6|||||TWO_SIDED|95.0|-45.1|84.2|||||A positive value would be considered as favoring doravirine over efavirenz.|||84.2|-45.1|
71103591|NCT02507934|141714871|SUPERIORITY||Mean Difference (Final Values)|12.7||||0.1047|TWO_SIDED|95.0|-2.78|28.18|||Student t-test for unpaired data|||T-test on changes from baseline in symptom assessment in dry eye - Severity - Day 14±1||28.18|-2.78|0.1047
71103592|NCT02507934|141714871|SUPERIORITY||Mean Difference (Final Values)|13.4||||0.1108|TWO_SIDED|95.0|-3.24|30.04|||Student t-test for unpaired data|||T-test on changes from baseline in symptom assessment in dry eye - Severity - Day 21±1||30.04|-3.24|0.1108
71103593|NCT02507934|141714872|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.498|TWO_SIDED|95.0|-0.4|0.81|||Student t-test for unpaired data|||T-test on changes from baseline in Ocular Protection Index - Left eye - Day 7±1||0.81|-0.40|0.4980
70928564|NCT06473662|141352927|OTHER||Mean Difference (Final Values)|-18.8||||0.0166|TWO_SIDED||||||t-test, 2 sided|||||||0.0166
70928565|NCT06473662|141352929|OTHER||Mean Difference (Final Values)|-22.13||||0.0474|TWO_SIDED||||||ANCOVA|||||||0.0474
70928566|NCT05764525|141352940|SUPERIORITY||Difference of least squares mean|6.938||||0.0047|TWO_SIDED|95.0|2.145|11.731|||ANOVA|||||11.731|2.145|0.0047
70928567|NCT03334630|141352943|NON_INFERIORITY|Assuming a Control composite SAE freedom rate of 93.5%, 226 subjects per group yields 80% power to detect a non-inferiority margin of -6.5% between treatment groups at a significance level of 0.025.|Risk Difference (RD)|0.0324|||<|0.0001|TWO_SIDED|95.0|-0.0132|0.0779||The a priori threshold for statistical significance is 0.025.|Farrington-Manning non-inferiority test||Estimated risk difference = DiamondTemp composite SAE freedom rate - Control composite SAE freedom rate = 3.24% = 0.0324|Null hypothesis: the DiamondTemp arm is inferior to the Control arm. Alternative hypothesis: the DiamondTemp arm is non-inferior to the Control arm.||0.0779|-0.0132|<0.0001
71046409|NCT00518882|141601177|SUPERIORITY_OR_OTHER||Mean|0.0|STANDARD_DEVIATION|0.96||0.7888||95.0|-0.16|0.12|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.12|-0.16|0.7888
71046410|NCT00518882|141601178|SUPERIORITY_OR_OTHER||Mean|-0.3|STANDARD_DEVIATION|1.07||0.0003||95.0|-0.43|-0.13|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.13|-0.43|0.0003
71010325|NCT01632345|141527517|SUPERIORITY_OR_OTHER||Difference in CD4 change|6.3|||||TWO_SIDED|95.0|-38.2|50.8|||||A positive value would be considered as favoring doravirine over efavirenz.|||50.8|-38.2|
71010326|NCT01632345|141527518|SUPERIORITY_OR_OTHER||Difference in CD4 change|-2.6|||||TWO_SIDED|95.0|-46.5|41.3|||||A positive value would be considered as favoring doravirine over efavirenz.|||41.3|-46.5|
71010327|NCT01632345|141527519|SUPERIORITY_OR_OTHER||Difference in CD4 change|-4.4|||||TWO_SIDED|95.0|-64.0|55.1|||||A positive value would be considered as favoring doravirine over efavirenz.|||55.1|-64.0|
71010328|NCT01632345|141527520|SUPERIORITY_OR_OTHER||Difference|-2.8|||||TWO_SIDED|95.0|-11.7|6.0|||||A negative value would be considered as favoring doravirine over efavirenz.|||6.0|-11.7|
71010329|NCT01632345|141527521|SUPERIORITY_OR_OTHER||Difference|-6.5|||||TWO_SIDED|95.0|-14.1|0.3|||||A negative value would be considered as favoring doravirine over efavirenz.|||0.3|-14.1|
71010330|NCT04269629|141527527|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACEI) and the group without such treatment. The primary outcome was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.25||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||It was assumed that 24% of the patients would be on β-blockers and/or ACE inhibitors (ACEI). A χ2 test with a two-sided 5% significance level has an 80% power to detect the difference between the group without antihypertensive medication with 6% SR during VIT and the group on β-blockers and/or ACEI with 12.3% SR during VIT (OR = 2.2) when the sample sizes are 631 and 200, respectively. A drop-out rate of 37% was assumed which resulted in a required number of 1,319 patients.||||0.25
71010331|NCT04269629|141527528|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.29||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||||||0.29
71010332|NCT04269629|141527529|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitor) and the group without such treatment. The secondary outcomes were analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.04||||||The level of significance was set at 0.05. Correlation of the prevalence of cardiovascular diseases and/or hypertension with the risk for more severe systemic sting reactions (p=0.04).|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||Analysis for correlation of the prevalence of cardiovascular diseases and/or hypertension with the risk for more severe systemic sting reactions.||||0.04
71010333|NCT04269629|141527530|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.|||||<|0.001||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||||||<0.001
71010334|NCT04269629|141527531|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.99||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||Analysis for sIgE levels - bee venom.||||0.99
71010335|NCT04269629|141527531|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.15||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||Analysis for sIgE levels - vespid venom.||||0.15
71046411|NCT00518882|141601178|SUPERIORITY_OR_OTHER||Mean|-0.1|STANDARD_DEVIATION|1.47||0.2078||95.0|-0.35|0.08|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.08|-0.35|0.2078
71046412|NCT00518882|141601179|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.07||||0.0014||95.0|-0.11|-0.03||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||-0.03|-0.11|0.0014
71046413|NCT00518882|141601180|SUPERIORITY_OR_OTHER||Mean|0.06|STANDARD_DEVIATION|0.269||0.0018||95.0|0.023|0.098|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.098|0.023|0.0018
71046414|NCT00518882|141601180|SUPERIORITY_OR_OTHER||Mean|0.01|STANDARD_DEVIATION|0.272||0.5499||95.0|-0.028|0.052|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.052|-0.028|0.5499
71046415|NCT00518882|141601181|SUPERIORITY_OR_OTHER||Mean|-0.1|STANDARD_DEVIATION|0.273|<|0.0001||95.0|-0.14|-0.062|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.062|-0.140|<0.0001
71046416|NCT00518882|141601181|SUPERIORITY_OR_OTHER||Mean|-0.07|STANDARD_DEVIATION|0.302||0.0012||95.0|-0.118|-0.03|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||-0.030|-0.118|0.0012
71046417|NCT00518882|141601182|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.02||||0.1119||95.0|-0.05|0.01||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||0.01|-0.05|0.1119
71046418|NCT00518882|141601183|SUPERIORITY_OR_OTHER||Mean|-0.02|STANDARD_DEVIATION|0.168||0.1342||95.0|-0.041|0.006|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.006|-0.041|0.1342
71046419|NCT00518882|141601183|SUPERIORITY_OR_OTHER||Mean|-0.03|STANDARD_DEVIATION|0.189||0.0344||95.0|-0.057|-0.002|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||-0.002|-0.057|0.0344
71046420|NCT00518882|141601184|SUPERIORITY_OR_OTHER||Mean|-0.08|STANDARD_DEVIATION|0.176|<|0.0001||95.0|-0.105|-0.056|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.056|-0.105|<0.0001
71046421|NCT00518882|141601184|SUPERIORITY_OR_OTHER||Mean|-0.07|STANDARD_DEVIATION|0.192|<|0.0001||95.0|-0.094|-0.038|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.038|-0.094|<0.0001
71046422|NCT02696031|141601199|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0197|TWO_SIDED|95.0|1.09|2.7||unadjusted p-value|Regression, Logistic|||week 16||2.70|1.09|0.0197
71046423|NCT02696031|141601199|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0146|TWO_SIDED|95.0|1.12|2.76||unadjusted p-value|Regression, Logistic|||week 16||2.76|1.12|0.0146
71046424|NCT02696031|141601200|SUPERIORITY||Odds Ratio (OR)|2.21||||0.0017|TWO_SIDED|95.0|1.35|3.63||unadjusted p-value|Regression, Logistic|||week 52||3.63|1.35|0.0017
71046425|NCT02696031|141601200|SUPERIORITY||Odds Ratio (OR)|2.67|||<|0.0001|TWO_SIDED|95.0|1.64|4.36||unadjusted p-value|Regression, Logistic|||week 52||4.36|1.64|<.0001
71046426|NCT02696031|141601201|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0108|TWO_SIDED|95.0|1.14|2.74||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight as a covariate.|2.74|1.14|0.0108
71103594|NCT02507934|141714872|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.1986|TWO_SIDED|95.0|-0.18|0.83|||Student t-test for unpaired data|||T-test on changes from baseline in Ocular Protection Index - Right eye - Day 7±1||0.83|-0.18|0.1986
71103595|NCT02507934|141714872|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.4067|TWO_SIDED|95.0|-0.9|0.37|||Student t-test for unpaired data|||T-test on changes from baseline in Ocular Protection Index - Left eye - Day 14±1||0.37|-0.90|0.4067
71103596|NCT02507934|141714872|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.5256|TWO_SIDED|95.0|-0.81|0.42|||Student t-test for unpaired data|||T-test on changes from baseline in Ocular Protection Index - Right eye - Day 14±1||0.42|-0.81|0.5256
71103597|NCT02507934|141714872|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.1471|TWO_SIDED|95.0|-1.12|0.17|||Student t-test for unpaired data|||T-test on changes from baseline in Ocular Protection Index - Left eye - Day 21±1||0.17|-1.12|0.1471
71046427|NCT02696031|141601201|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0087|TWO_SIDED|95.0|1.16|2.78||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight as a covariate.|2.78|1.16|0.0087
71046428|NCT02696031|141601201|SUPERIORITY|week 52|Odds Ratio (OR)|2.16||||0.0016|TWO_SIDED|95.0|1.34|3.49||unadjusted p-value|Regression, Linear||||Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight as a covariate.|3.49|1.34|0.0016
71046429|NCT02696031|141601201|SUPERIORITY|week 52|Median Difference (Net)|2.61|||<|0.0001|TWO_SIDED|95.0|1.62|4.19||unadjusted p-value|Regression, Linear||||Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight as a covariate.|4.19|1.62|<.0001
71046430|NCT02696031|141601202|SUPERIORITY||Odds Ratio (OR)|1.6||||0.026|TWO_SIDED|95.0|1.06|2.43||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight as a covariate.|2.43|1.06|0.0260
71046431|NCT02696031|141601202|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0149|TWO_SIDED|95.0|1.11|2.54||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight as a covariate.|2.54|1.11|0.0149
71046432|NCT02696031|141601203|SUPERIORITY||Odds Ratio (OR)|2.26||||0.0005|TWO_SIDED|95.0|1.43|3.58||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNF-alpha status as factors and baseline weight as a covariate.|3.58|1.43|0.0005
71046433|NCT02696031|141601203|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0094|TWO_SIDED|95.0|1.16|2.94||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNF-alpha status as factors and baseline weight as a covariate.|2.94|1.16|0.0094
71046434|NCT02696031|141601204|SUPERIORITY||Odds Ratio (OR)|3.8|||<|0.0001|TWO_SIDED|95.0|1.95|7.39||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNF-alpha status as factors and baseline weight as a covariate.|7.39|1.95|<.0001
71046435|NCT02696031|141601204|SUPERIORITY||Odds Ratio (OR)|3.64||||0.0001|TWO_SIDED|95.0|1.87|7.1||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNF-alpha status as factors and baseline weight as a covariate.|7.10|1.87|0.0001
71046436|NCT02696031|141601205|SUPERIORITY||LS Mean|-0.75|STANDARD_ERROR_OF_MEAN|0.259||0.0041|TWO_SIDED|95.0|-1.26|-0.24||unadjusted p-value|MMRM|||week 16|LS Mean, 95% CI, and p-value were from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|-0.24|-1.26|0.0041
71046437|NCT02696031|141601205|SUPERIORITY||LS Mean|-0.64|STANDARD_ERROR_OF_MEAN|0.259||0.0143|TWO_SIDED|95.0|-1.15|-0.13||unadjusted p-value|MMRM|||week 16|LS Mean, 95% CI, and p-value were from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|-0.13|-1.15|0.0143
71046438|NCT02696031|141601206|SUPERIORITY||Odds Ratio (OR)|2.53||||0.0001|TWO_SIDED|95.0|1.58|4.07||unadjusted p-value|Regression, Logistic|||week 16|"Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight and baseline score as covariates.~Missing responses for any reason were imputed as non-responders."|4.07|1.58|0.0001
71046439|NCT02696031|141601206|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0002|TWO_SIDED|95.0|1.51|3.89||unadjusted p-value|Regression, Logistic|||week 16|"Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight and baseline score as covariates.~Missing responses for any reason were imputed as non-responders."|3.89|1.51|0.0002
71046440|NCT02696031|141601206|SUPERIORITY||Odds Ratio (OR)|1.99||||0.0056|TWO_SIDED|95.0|1.22|3.24||unadjusted p-value|Regression, Logistic|||week 52|"Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight and baseline score as covariates.~Missing responses for any reason were imputed as non-responders."|3.24|1.22|0.0056
71046441|NCT02696031|141601206|SUPERIORITY||Odds Ratio (OR)|2.34||||0.0005|TWO_SIDED|95.0|1.45|3.78||unadjusted p-value|Regression, Logistic|||week 52|"Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight and baseline score as covariates.~Missing responses for any reason were imputed as non-responders."|3.78|1.45|0.0005
71046442|NCT02696031|141601207|SUPERIORITY||LS Mean of treatment difference|-0.89|STANDARD_ERROR_OF_MEAN|0.256||0.0006|TWO_SIDED|95.0|-1.39|-0.38||unadjusted p-value|mixed model repeated measures (MMRM)|||week 16|LS Mean, 95% CI, and p-value were from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|-0.38|-1.39|0.0006
71046443|NCT02696031|141601207|SUPERIORITY||LS Mean of Treatment Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.255||0.0002|TWO_SIDED|95.0|-1.47|-0.47||unadjusted p-value|mixed model repeated measures (MMRM)|||week 16|LS Mean, 95% CI, and p-value were from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|-0.47|-1.47|0.0002
71046444|NCT02696031|141601208|SUPERIORITY||LS Mean|-1.61|STANDARD_ERROR_OF_MEAN|0.478||0.0008|TWO_SIDED|95.0|-2.54|-0.67||unadjusted p-value|MMRM|||week 16|LS Mean, 95% CI, and p-value are from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|-0.67|-2.54|0.0008
70928568|NCT03334630|141352944|NON_INFERIORITY|Assuming a Control primary effectiveness rate of 65%, 229 subjects per group yields 80% power to detect a non-inferiority margin of -12.5% between treatment groups at a significance level of 0.025.|Risk Difference (RD)|0.034|||<|0.0001|TWO_SIDED|95.0|-0.042|0.109||The a priori threshold for statistical significance is 0.025.|Farrington-Manning non-inferiority test||Estimated risk difference = DiamondTemp composite SAE freedom rate - Control composite SAE freedom rate = 3.4% = 0.034|Null hypothesis: the DiamondTemp arm is inferior to the Control arm. Alternative hypothesis: the DiamondTemp arm is non-inferior to the Control arm.||0.109|-0.042|<0.0001
71010336|NCT04269629|141527532|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.16||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||||||0.16
71010337|NCT04269629|141527533|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.5||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||||||0.50
71046445|NCT02696031|141601208|SUPERIORITY||LS Mean|-1.78|STANDARD_ERROR_OF_MEAN|0.479||0.0002|TWO_SIDED|95.0|-2.72|-0.84||unadjusted p-value|MMRM|||week 16|LS Mean, 95% CI, and p-value are from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|-0.84|-2.72|0.0002
71010338|NCT04269629|141527534|OTHER|||||||0.72||||||The level of significance was set at 0.05.|Fisher Exact|||||||0.72
71010339|NCT04269629|141527535|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitor) and the group without such treatment. The secondary outcomes were analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.11||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||Analysis for correlation of the prevalence of cardiovascular diseases and/or hypertension with the risk for more frequent SR under VIT.||||0.11
71010340|NCT01997333|141527541|SUPERIORITY|||||||0.761|||||||Log Rank|Stratified log rank test.||||||0.761
71010341|NCT01997333|141527542|SUPERIORITY|||||||0.264|||||||Cochran-Mantel-Haenszel|Adjusted for stratification factors.||||||0.264
71010342|NCT01997333|141527544|SUPERIORITY|||||||0.726|||||||Log Rank|Stratified log rank.||||||0.726
71010343|NCT01535638|141527547|SUPERIORITY_OR_OTHER||Ratio (%)|123.4|STANDARD_DEVIATION|17.1|||TWO_SIDED|90.0|108.0|141.1|||||The estimate of the relative bioavailability (%) is adjusted for the period effects in the ANOVA. The standard deviation is actually the gCV. CIs are based on the residual error from ANOVA, considering only the data from the 2 compared treatments.|Relative bioavailability comparison of Deleobuvir Trial Formulation II (reference) and Deleobuvir Final Formulation (test) in pairwise comparison. (reference : test)||141.1|108.0|
71010344|NCT01535638|141527547|SUPERIORITY_OR_OTHER||Ratio (%)|109.8|STANDARD_DEVIATION|28.8|||TWO_SIDED|90.0|88.6|136.1|||||The estimate of the relative bioavailability (%) is adjusted for the period effects in the ANOVA. The standard deviation is actually the gCV. CIs are based on the residual error from ANOVA, considering only the data from the 2 compared treatments.|relative bioavailability comparison of Deleobuvir Final Formulation modified (test) and Deleobuvir Final Formulation (reference) in pairwise comparison. (reference : test)||136.1|88.6|
71010345|NCT01535638|141527548|SUPERIORITY_OR_OTHER||Ratio (%)|122.5|STANDARD_DEVIATION|16.1|||TWO_SIDED|90.0|107.9|139.1|||||The estimate of the relative bioavailability (%) is adjusted for the period effects in the ANOVA. The standard deviation is actually the gCV. CIs are based on the residual error from ANOVA, considering only the data from the 2 compared treatments.|relative bioavailability comparison of Deleobuvir Final Formulation (test) and Deleobuvir Trial Formulation II (reference) in pairwise comparison. (test : reference)||139.1|107.9|
71010346|NCT01535638|141527548|SUPERIORITY_OR_OTHER||Ratio (%)|107.6|STANDARD_DEVIATION|35.0|||TWO_SIDED|90.0|83.1|139.4|||||The estimate of the relative bioavailability (%) is adjusted for the period effects in the ANOVA. The standard deviation is actually the gCV. CIs are based on the residual error from ANOVA, considering only the data from the 2 compared treatments.|relative bioavailability comparison of Deleobuvir Final Formulation modified (test) and Deleobuvir Final Formulation (reference) in pairwise comparison. (test : reference)||139.4|83.1|
71010347|NCT00819052|141527558|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of nevirapine XR to nevirapine IR was established if the lower bound of the confidence interval was greater than -12%|Cochran's statistic|1.0||||||95.0|-4.3|6.2|||Cochran's statistic||Weighted treatment difference and corresponding variance were calculated based on Cochran's statistic.|||6.2|-4.3|
71010348|NCT00819052|141527571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.64||||0.7587||95.0|-34.34|25.05|||ANCOVA|Means adjusted for background ARV (Antiretroviral) stratum||||25.05|-34.34|0.7587
71103598|NCT02507934|141714872|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.2455|TWO_SIDED|95.0|-0.96|0.25|||Student t-test for unpaired data|||T-test on changes from baseline in Ocular Protection Index - Right eye - Day 21±1||0.25|-0.96|0.2455
71103599|NCT02507934|141714873|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.4233|TWO_SIDED|95.0|-1.98|0.85|||Student t-test for unpaired data|||T test p-value - Left eye - Day 7±1||0.85|-1.98|0.4233
71010349|NCT01277666|141527607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.546|TWO_SIDED|95.0|-6.1|11.0|||Mantel Haenszel|||comparison of Placebo and GSK1605786A 500 mg once daily||11.0|-6.1|0.546
71010350|NCT01277666|141527607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1||||0.648|TWO_SIDED|95.0|-6.5|10.7|||Mantel Haenszel|||comparison of Placebo and GSK1605786A 500 mg twice daily||10.7|-6.5|0.648
71010351|NCT01277666|141527608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.592|TWO_SIDED|95.0|-8.8|4.8|||Mantel Haenszel|||||4.8|-8.8|0.592
71010352|NCT01277666|141527608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.475|TWO_SIDED|95.0|-9.2|4.4|||Mantel Haenszel|||||4.4|-9.2|0.475
71010353|NCT01277666|141527609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||0.415|TWO_SIDED|95.0|-4.4|10.3|||Mantel Haenszel|||||10.3|-4.4|0.415
71010354|NCT01277666|141527609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.354|TWO_SIDED|95.0|-3.9|10.9|||Mantel Haenszel|||||10.9|-3.9|0.354
71010355|NCT01277666|141527610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.985|TWO_SIDED|95.0|-5.2|5.2|||Mantel Haenszel|||||5.2|-5.2|0.985
71010356|NCT01277666|141527610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.709|TWO_SIDED|95.0|-6.1|4.1|||Mantel Haenszel|||||4.1|-6.1|0.709
71010357|NCT01277666|141527611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.633|TWO_SIDED|95.0|-6.5|10.4|||Mantel Haenszel|||||10.4|-6.5|0.633
71010358|NCT01277666|141527611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.889|TWO_SIDED|95.0|-7.8|9.0|||Mantel Haenszel|||||9.0|-7.8|0.889
71010359|NCT01277666|141527612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.541|TWO_SIDED|95.0|-8.1|4.2|||Mantel Haenszel|||||4.2|-8.1|0.541
71010360|NCT01277666|141527612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.43|TWO_SIDED|95.0|-8.5|3.7|||Mantel Haenszel|||||3.7|-8.5|0.430
71010361|NCT01277666|141527613|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.13|STANDARD_ERROR_OF_MEAN|2.426||0.642|TWO_SIDED|95.0|-5.89|3.64||P-values were obtained from an analysis of covariance model with baseline score as the covariate.|ANCOVA|||Week 8||3.64|-5.89|0.642
71010362|NCT01277666|141527613|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|2.652||0.898|TWO_SIDED|95.0|-5.55|4.87||P-values were obtained from an analysis of covariance model with baseline score as the covariate.|ANCOVA|||Week 12||4.87|-5.55|0.898
71010363|NCT01277666|141527613|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.37|STANDARD_ERROR_OF_MEAN|2.467||0.173|TWO_SIDED|95.0|-1.48|8.21||P-values were obtained from an analysis of covariance model with baseline score as the covariate.|ANCOVA|||Week 8||8.21|-1.48|0.173
71010364|NCT01277666|141527613|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.85|STANDARD_ERROR_OF_MEAN|2.697||0.493|TWO_SIDED|95.0|-3.45|7.15||P-values were obtained from an analysis of covariance model with baseline score as the covariate.|ANCOVA|||Week 12||7.15|-3.45|0.493
71010365|NCT03702166|141527615|SUPERIORITY|||||||0.01|||||||t-test, 1 sided|Multiple t-tests with Bonferroni corrections for multiple comparisons||||||0.01
71010366|NCT03702166|141527617|SUPERIORITY|||||||0.038|||||||t-test, 1 sided|Multiple t-tests, with Bonferroni corrections for multiple comparisons,||||||0.038
71010367|NCT03702166|141527619|SUPERIORITY|||||||0.031||||||Multiple t-tests, with Bonferroni corrections for multiple comparisons|t-test, 1 sided|||||||0.031
71010368|NCT01657903|141527621|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|41.15|||<|0.0001|TWO_SIDED|95.0|34.42|47.89||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %RER. Statistical tests were 2-sided with a significance level of 0.05.||47.89|34.42|<0.0001
71103600|NCT02507934|141714873|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.6335|TWO_SIDED|95.0|-1.04|1.69|||Student t-test for unpaired data|||T test p-value - Right eye - Day 7±1||1.69|-1.04|0.6335
71103601|NCT02507934|141714873|SUPERIORITY||Mean Difference (Final Values)|-2.04||||0.0103|TWO_SIDED|95.0|-3.56|-0.51|||Student t-test for unpaired data|||T test p-value - Left eye - Day 14±1||-0.51|-3.56|0.0103
71010369|NCT01657903|141527621|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|41.28|||<|0.0001|TWO_SIDED|95.0|34.51|48.06||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %RER. Statistical tests were 2-sided with a significance level of 0.05.||48.06|34.51|<0.0001
71010370|NCT01657903|141527621|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|40.83|||<|0.0001|TWO_SIDED|95.0|34.06|47.61||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %RER. Statistical tests were 2-sided with a significance level of 0.05.||47.61|34.06|<0.0001
71010371|NCT01657903|141527622|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.36|||<|0.0001|TWO_SIDED|95.0|6.01|12.72||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||12.72|6.01|<0.0001
71103602|NCT02507934|141714873|SUPERIORITY||Mean Difference (Final Values)|-1.34||||0.1006|TWO_SIDED|95.0|-2.95|0.27|||Student t-test for unpaired data|||T test p-value - Right eye - Day 14±1||0.27|-2.95|0.1006
70928569|NCT03334630|141352945|SUPERIORITY|"Four secondary endpoints will be tested for superiority over Control hierarchically with pre-specified order:~1. Mean duration of individual RF ablations (seconds)~2. Mean cumulative RF time per procedure (minutes)~3. Total fluoroscopy time (minutes)~4. Total procedure time (minutes) The first secondary endpoint needs to be significant at the two-sided 0.05 alpha level before the next one can be tested at the same threshold. Testing stops once an endpoint is determined to be non-significant."|Mean Difference (Final Values)|-17.9|||<|0.0001|TWO_SIDED|95.0|-21.2|-14.6||The a priori threshold for statistical significance is 0.05 two-sided. The p-value is adjusted for multiple comparisons via the hierarchical testing approach.|t-test, 2 sided||Difference is DiamondTemp minus Control. A lower value is better.|"Null hypothesis: the population means for the DiamondTemp and Control groups are not different.~Alternative hypothesis: the population means for the DiamondTemp and Control groups are different."||-14.6|-21.2|<0.0001
70928570|NCT03334630|141352946|SUPERIORITY|"Four secondary endpoints will be tested for superiority over Control hierarchically with pre-specified order:~1. Mean duration of individual RF ablations (seconds)~2. Mean cumulative RF time per procedure (minutes)~3. Total fluoroscopy time (minutes)~4. Total procedure time (minutes) The first secondary endpoint needs to be significant at the two-sided 0.05 alpha level before the next one can be tested at the same threshold. Testing stops once an endpoint is determined to be non-significant."|Mean Difference (Final Values)|-11.9|||<|0.0001|TWO_SIDED|95.0|-13.9|-9.8||The a priori threshold for statistical significance is 0.05 two-sided. The p-value is adjusted for multiple comparisons via the hierarchical testing approach.|t-test, 2 sided||Difference is DiamondTemp minus Control. A lower value is better.|"Null hypothesis: the population means for the DiamondTemp and Control groups are not different.~Alternative hypothesis: the population means for the DiamondTemp and Control groups are different."||-9.8|-13.9|<0.0001
70941342|NCT00924833|141383251|SUPERIORITY_OR_OTHER|||||||0.01||||||"Within subjects effects. Time: P \< 0.01. Time \* treatment: P=0.25~Bonferroni correction. Within the placebo, carvedilol and nebivolol group, p \< 0.01 for Time 3 - Time 1, and Time 3 - Time 2."|ANOVA|||"Differences among groups, changes over time and interactions: two-way repeated measures ANOVA with unpaired Student's t-test, Bonferroni correction.~No previous studies have compared carvedilol, nebivolol, and placebo with respecto to exercise performance in hypobaric hypoxia. The sample size set for each treatment arm was defined on the basis of the sample size of previous investigations showing significant changes in exercise performance in normal subjects."||||0.01
71010372|NCT01657903|141527622|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.45|||<|0.0001|TWO_SIDED|95.0|6.07|12.82||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||12.82|6.07|<0.0001
71010373|NCT01657903|141527622|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.66|||<|0.0001|TWO_SIDED|95.0|8.28|15.03||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||15.03|8.28|<0.0001
71010374|NCT00620815|141527632|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Group Mean Ratio|1.13|||||TWO_SIDED|96.67|1.02|1.25||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 1) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.25|1.02|
71010375|NCT00620815|141527632|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|1.01|||||TWO_SIDED|96.67|0.91|1.12||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 1) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.12|0.91|
71010376|NCT00620815|141527632|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratio|0.89|||||TWO_SIDED|96.67|0.8|0.99||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 1)Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||0.99|0.80|
71010377|NCT00620815|141527632|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|1.19|||||TWO_SIDED|96.67|0.74|1.93||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 22) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.93|0.74|
71010378|NCT00620815|141527632|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|0.85|||||TWO_SIDED|96.67|0.52|1.38||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 22) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.38|0.52|
71046446|NCT02696031|141601209|SUPERIORITY|||||||0.0012||||||unadjusted p-value|Wilcoxon (Mann-Whitney)|The endpoint was analyzed by composite estimand strategy. Extreme unfavorable value is assigned for patients with treatment escape or missing data.||||||0.0012
71046447|NCT02696031|141601209|SUPERIORITY||||||<|0.0001||||||unadjusted p-value|Wilcoxon (Mann-Whitney)|The endpoint was analyzed by composite estimand strategy. Extreme unfavorable value is assigned for patients with treatment escape or missing data.||||||<.0001
71103603|NCT02507934|141714873|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.0041|TWO_SIDED|95.0|-4.15|-0.85|||Student t-test for unpaired data|||T test p-value - Left eye - Day 21±1||-0.85|-4.15|0.0041
70941343|NCT00924833|141383252|SUPERIORITY_OR_OTHER||||||<|0.05||||||P \< 0.05. Bonferroni correction: p \< 0.05 nebivolol versus carvedilol|ANOVA|||No previous studies have compared carvedilol, nebivolol, and placebo with respecto to exercise performance in hypobaric hypoxia. The sample size set for each treatment arm was defined on the basis of the sample size of previous investigations showing significant changes in exercise performance in normal subjects.||||<0.05
71103604|NCT02507934|141714873|SUPERIORITY||Mean Difference (Final Values)|-1.87||||0.0429|TWO_SIDED|95.0|-3.67|-0.06|||Student t-test for unpaired data|||T test p-value - Right eye - Day 21±1||-0.06|-3.67|0.0429
71103605|NCT02507934|141714874|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.2338|TWO_SIDED|95.0|-0.75|0.19|||Student t-test for unpaired data|||T-test on changes from baseline in Visual acuity score - Left eye - Day 7±1||0.19|-0.75|0.2338
71010379|NCT00620815|141527632|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|0.71|||||TWO_SIDED|96.67|0.44|1.15||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 22) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.15|0.44|
71010380|NCT00620815|141527632|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|1.14|||||TWO_SIDED|96.67|1.01|1.3||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 43) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.30|1.01|
71010381|NCT00620815|141527632|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|1.05|||||TWO_SIDED|96.67|0.93|1.19||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 43) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.19|0.93|
71010382|NCT00620815|141527632|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|0.92|||||TWO_SIDED|96.67|0.81|1.04||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 43) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.04|0.81|
71010383|NCT00842829|141527652|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper limit of the 90% CI was \<8%.|Mean Difference (Net)|-6.3|||||ONE_SIDED|95.0||1.4|||||The upper bound of the 2-sided 90% confidence interval is equivalent to the upper bound of the 1-sided 95% confidence interval.|Treatment comparison difference (100 mcg - 200 mcg)||1.4||
71010384|NCT02155725|141527676|SUPERIORITY||Odds Ratio (OR)|0.9889||||0.9563|TWO_SIDED|95.0|0.6633|1.4744|||Regression, Logistic|||||1.4744|0.6633|0.9563
71010385|NCT02155725|141527677|SUPERIORITY||Odds Ratio (OR)|1.0064||||0.9786|TWO_SIDED|95.0|0.6321|1.6022|||Regression, Logistic|||Failure on individual component of the primary endpoint defined as administration of 2 units of RBCs.||1.6022|0.6321|0.9786
71010386|NCT02155725|141527678|SUPERIORITY||Odds Ratio (OR)|1.0169||||0.9474|TWO_SIDED|95.0|0.6177|1.6741|||Regression, Logistic|||Failure on individual component of the primary endpoint defined as a loss of at least 4 g/dL of Hb.||1.6741|0.6177|0.9474
71010387|NCT00149227|141527693|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8|STANDARD_DEVIATION|2.0|<|0.05|TWO_SIDED|95.0|-0.975|0.975|||Cox's proportional hazard analysis|||"We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.~with a two-tailed 5% statistical signiﬁcant level."||0.975|-0.975|<0.05
71010388|NCT01249404|141527723|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|-0.1|||=|0.2859|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA||LS Means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, BTX treatment status at baseline and centre as covariates.|The least squares mean change from baseline to Week 4 for MAS in the Dysport® 1000 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect analysis of covariance (ANCOVA) model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.||0.1|-0.3|=0.2859
71010389|NCT01249404|141527723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|||=|0.0091|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA||LS Means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, BTX treatment status at baseline and centre as covariates.|The least squares mean change from baseline to Week 4 for MAS in the Dysport® 1500 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect ANCOVA model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.||-0.1|-0.5|=0.0091
71010390|NCT01249404|141527724|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.3|||=|0.064|TWO_SIDED|95.0|0.0|0.5|||ANCOVA||LS means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on visit results with treatment, BTX treatment status at baseline and centre as covariates.|The mean PGA at Week 4 in the Dysport® 1000 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect ANCOVA model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.||0.5|-0.0|=0.0640
71010391|NCT01249404|141527724|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.3|||=|0.0665|TWO_SIDED|95.0|0.0|0.5|||ANCOVA||LS means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on visit results with treatment, BTX treatment status at baseline and centre as covariates.|The mean PGA at Week 4 in the Dysport® 1500 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect ANCOVA model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.||0.5|-0.0|=0.0665
71103606|NCT02507934|141714874|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.3081|TWO_SIDED|95.0|-0.58|0.19|||Student t-test for unpaired data|||T-test on changes from baseline in Visual acuity score - Right eye - Day 7±1||0.19|-0.58|0.3081
71103607|NCT02507934|141714874|SUPERIORITY||Mean Difference (Final Values)|1.59||||0.4287|TWO_SIDED|95.0|-2.57|5.74|||Student t-test for unpaired data|||T-test on changes from baseline in Visual acuity score - Left eye - Day 14±1||5.74|-2.57|0.4287
71103608|NCT02507934|141714874|SUPERIORITY||Mean Difference (Final Values)|1.15||||0.5765|TWO_SIDED|95.0|-3.14|5.44|||Student t-test for unpaired data|||T-test on changes from baseline in Visual acuity score - Right eye - Day 14±1||5.44|-3.14|0.5765
71103609|NCT02507934|141714874|SUPERIORITY||Mean Difference (Final Values)|-1.17||||0.0259|TWO_SIDED|95.0|-2.18|-0.15|||Student t-test for unpaired data|||T-test on changes from baseline in Visual acuity score - Left eye - Day 21±1||-0.15|-2.18|0.0259
71103610|NCT02507934|141714874|SUPERIORITY||Mean Difference (Final Values)|-0.93||||0.1496|TWO_SIDED|95.0|-2.23|0.37|||Student t-test for unpaired data|||T-test on changes from baseline in Visual acuity score - Right eye - Day 21±1||0.37|-2.23|0.1496
71103611|NCT02507934|141714875|SUPERIORITY|||||||0.2342|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Right - Day 7±1||||0.2342
71103612|NCT02507934|141714875|SUPERIORITY|||||||0.8874|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Left - Day 7±1||||0.8874
71103613|NCT02507934|141714875|SUPERIORITY|||||||0.0504|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Right - Day 7±1||||0.0504
71103614|NCT02507934|141714875|SUPERIORITY|||||||0.0814|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Left - Day 7±1||||0.0814
71103615|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Right - Day 7±1||||1.0000
71010392|NCT01249404|141527724|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.2||||0.0466|TWO_SIDED||||||ANCOVA on rank PGA scores||LS means for each treatment group and treatment comparisons and the p-values are obtained from an analysis of variance on visit results based on ranked values with treatment, BTX treatment status at baseline and centre as explanatory variables.|The LS mean rank values were back transformed to the original scale to give ranked PGA scores in an attempt to better normalise the data and restore power.||||0.0466
71103616|NCT02507934|141714875|SUPERIORITY|||||||0.3855|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Left - Day 7±1||||0.3855
71103617|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Right - Day 7±1||||1.0000
71103618|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Left - Day 7±1||||1.0000
71103619|NCT02507934|141714875|SUPERIORITY|||||||0.4754|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Right - Day 7±1||||0.4754
71103620|NCT02507934|141714875|SUPERIORITY|||||||0.2914|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Left - Day 7±1||||0.2914
71103621|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Right - Day 7±1||||1.0000
71103622|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Left - Day 7±1||||1.0000
71103623|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Right - Day 7±1||||1.0000
71103624|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Left - Day 7±1||||1.0000
71103625|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Right - Day 7±1||||1.0000
71103626|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Left - Day 7±1||||1.0000
71103627|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Right - Day 7±1||||1.0000
71103628|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Left - Day 7±1||||1.0000
71103629|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Right - Day 7±1||||1.0000
71103630|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Left - Day 7±1||||1.0000
71103631|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Right - Day 7±1||||1.0000
71103632|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Left - Day 7±1||||1.0000
71103633|NCT02507934|141714875|SUPERIORITY|||||||0.2429|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Right - Day 14±1||||0.2429
71103634|NCT02507934|141714875|SUPERIORITY|||||||0.5707|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Left - Day 14±1||||0.5707
71103635|NCT02507934|141714875|SUPERIORITY|||||||0.0092|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Right - Day 14±1||||0.0092
71103636|NCT02507934|141714875|SUPERIORITY|||||||0.0039|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Left - Day 14±1||||0.0039
70928571|NCT03334630|141352955|SUPERIORITY|"Four secondary endpoints will be tested for superiority over Control hierarchically with pre-specified order:~1. Mean duration of individual RF ablations (seconds)~2. Mean cumulative RF time per procedure (minutes)~3. Total fluoroscopy time (minutes)~4. Total procedure time (minutes) The first secondary endpoint needs to be significant at the two-sided 0.05 alpha level before the next one can be tested at the same threshold. Testing stops once an endpoint is determined to be non-significant."|Mean Difference (Final Values)|-5.7|||||TWO_SIDED|95.0|-14.4|3.1||The a priori threshold for statistical significance is 0.05 two-sided. The p-value is adjusted for multiple comparisons via the hierarchical testing approach.||Since the previous secondary endpoint (Total fluoroscopy time) was non-significant, testing stopped and this secondary endpoint was not tested.|Difference is DiamondTemp minus Control. A lower value is better.|"Null hypothesis: the population means for the DiamondTemp and Control groups are not different.~Alternative hypothesis: the population means for the DiamondTemp and Control groups are different."||3.1|-14.4|
70928572|NCT03334630|141352960|SUPERIORITY|"Four secondary endpoints will be tested for superiority over Control hierarchically with pre-specified order:~1. Mean duration of individual RF ablations (seconds)~2. Mean cumulative RF time per procedure (minutes)~3. Total fluoroscopy time (minutes)~4. Total procedure time (minutes) The first secondary endpoint needs to be significant at the two-sided 0.05 alpha level before the next one can be tested at the same threshold. Testing stops once an endpoint is determined to be non-significant."|Mean Difference (Final Values)|-0.2||||0.8528|TWO_SIDED|95.0|-1.9|1.6||The a priori threshold for statistical significance is 0.05 two-sided. The p-value is adjusted for multiple comparisons via the hierarchical testing approach.|t-test, 2 sided||Difference is DiamondTemp minus Control. A lower value is better.|"Null hypothesis: the population means for the DiamondTemp and Control groups are not different.~Alternative hypothesis: the population means for the DiamondTemp and Control groups are different."||1.6|-1.9|0.8528
71103637|NCT02507934|141714875|SUPERIORITY|||||||0.2882|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Right - Day 14±1||||0.2882
70928573|NCT03910478|141353001|EQUIVALENCE|A two-sided Wald-test for evidence of a non-zero coefficient for intervention group in the regression was conducted at the 5% significance level.|Odds Ratio (OR)|0.948||||0.892|TWO_SIDED|95.0|0.438|2.053|||Regression, Logistic|The logistic regression was adjusted by covariates (transplant site and participant's perceived ease of access to blood draw facility).||A traditional logistic regression model was fit where the outcome was whether or not participants completed \> 90% of their clinician-recommended CMV monitoring tests in the study period by 1-year after HCT.||2.053|0.438|0.8920
70928574|NCT03910478|141353002|EQUIVALENCE|A two-sided Wald-test for evidence of a non-zero coefficient for intervention group in the regression was conducted at the 5% significance level.|Odds Ratio (OR)|0.66||||0.3008|TWO_SIDED|95.0|0.301|1.45|||Regression, Logistic|The logistic regression was adjusted by covariates (transplant site and participant's perceived ease of access to blood draw facility).||A traditional logistic regression model was fit where the outcome was whether or not participants completed \> 90% of their clinician -recommended CMV monitoring tests in the study period by 1-year after HCT.||1.450|0.301|0.3008
70928575|NCT06415292|141353031|SUPERIORITY||||||<|0.001||||||The P-value reported here is the calculated p-value. The p-value theshold for significance was p =0.05|t-test, 2 sided|||||||<0.001
70928576|NCT01712490|141353041|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.035|TWO_SIDED|95.0|0.603|0.983|||Log Rank|||Hazard ratio (A+AVD/ABVD) and 95% confidence interval (CI) are based on a stratified Cox's proportional hazard regression model with stratification factors region and number of International Prognostic Factor Project (IPFP) risk factors at baseline with treatment as the explanatory variable in the model. Hazard ratio less than (\<) 1 favors A+AVD arm.||0.983|0.603|0.035
70928577|NCT01712490|141353042|SUPERIORITY||Hazard Ratio (HR)|0.728||||0.199|TWO_SIDED|95.0|0.448|1.184|||Log Rank|||Hazard ratio (A+AVD/ABVD) and 95% CI are based on a stratified Cox's proportional hazard regression model with stratification factors region and number of IPFP risk factors at baseline with treatment as the explanatory variable in the model. Hazard ratio \<1 favors A+AVD arm.||1.184|0.448|0.199
71010393|NCT01249404|141527724|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.2||||0.0406|TWO_SIDED||||||ANCOVA on rank PGA scores||LS means for each treatment group and treatment comparisons and the p-values are obtained from an analysis of variance on visit results based on ranked values with treatment, BTX treatment status at baseline and centre as explanatory variables.|The LS mean rank values were back transformed to the original scale to give ranked PGA scores in an attempt to better normalise the data and restore power.||||0.0406
71010394|NCT01249404|141527725|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|||=|0.7247|TWO_SIDED|95.0|-0.02|0.03|||ANCOVA||LS Means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, BTX treatment status at baseline and centre as covariates.|The least squares mean change from baseline to Week 4 for barefoot comfortable walking speed in the Dysport® 1000 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect analysis of covariance (ANCOVA) model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.||0.03|-0.02|=0.7247
71010395|NCT01249404|141527725|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|||=|0.7266|TWO_SIDED|95.0|-0.03|0.02|||ANCOVA||LS Means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, BTX treatment status at baseline and centre as covariates.|The least squares mean change from baseline to Week 4 for barefoot comfortable walking speed in the Dysport® 1500 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect ANCOVA model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.||0.02|-0.03|=0.7266
71010396|NCT01020812|141527747|SUPERIORITY_OR_OTHER||proportion of participants|0.286|||||TWO_SIDED|95.0|0.031|0.636|||||The data was analyzed in a competing risk model with death as a competing risk. The proportion of 0.286 is the cumulative incidence function at 12 months.|The data was analyzed in a competitive risk model with the cumulative incidence function as the estimator. Death and other progression were competitive risks.||0.636|0.031|
71010397|NCT01020812|141527748|SUPERIORITY_OR_OTHER||probability|0.4|||||TWO_SIDED||||||||This is the overall survival probability at 18 months.|The data was analyzed using the Kaplan Meier estimator.||||
71103638|NCT02507934|141714875|SUPERIORITY|||||||0.4017|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Left - Day 14±1||||0.4017
71103639|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Right - Day 14±1||||1.0000
71103640|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Left - Day 14±1||||1.0000
71103641|NCT02507934|141714875|SUPERIORITY|||||||0.0731|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Right - Day 14±1||||0.0731
71103642|NCT02507934|141714875|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Left - Day 14±1||||0.0020
71103643|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Right - Day 14±1||||1.0000
71103644|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Left - Day 14±1||||1.0000
71103645|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Right - Day 14±1||||1.0000
71103646|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Left - Day 14±1||||1.0000
71103647|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Right - Day 14±1||||1.0000
71103648|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Left - Day 14±1||||1.0000
71103649|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Right - Day 14±1||||1.0000
71103650|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Left - Day 14±1||||1.0000
71010398|NCT03287960|141527779|OTHER|Two-sided confidence interval obtained using Clopper-Pearson method and one-sided p-value obtained from exact binomial test, testing that at least 5% of participants in the population of interest will achieve 10% weight loss.||||||0.0001|||||||Clopper-Pearson method|||||||0.0001
71103651|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Right - Day 14±1||||1.0000
71103652|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Left - Day 14±1||||1.0000
71103653|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Right - Day 14±1||||1.0000
71103654|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Left - Day 14±1||||1.0000
71103655|NCT02507934|141714875|SUPERIORITY|||||||0.1376|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Right - Day 21±1||||0.1376
71103656|NCT02507934|141714875|SUPERIORITY|||||||0.3252|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Left - Day 21±1||||0.3252
71103657|NCT02507934|141714875|SUPERIORITY|||||||0.0111|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Right - Day 21±1||||0.0111
71103658|NCT02507934|141714875|SUPERIORITY|||||||0.0049|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Right - Day 21±1||||0.0049
71103659|NCT02507934|141714875|SUPERIORITY|||||||0.1178|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Right - Day 21±1||||0.1178
71103660|NCT02507934|141714875|SUPERIORITY|||||||0.9042|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Left - Day 21±1||||0.9042
71103661|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Right - Day 21±1||||1.0000
71103662|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Left - Day 21±1||||1.0000
71103663|NCT02507934|141714875|SUPERIORITY|||||||0.0253|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Right - Day 21±1||||0.0253
71103664|NCT02507934|141714875|SUPERIORITY|||||||0.0016|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Left - Day 21±1||||0.0016
71103665|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Right - Day 21±1||||1.0000
71103666|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Left - Day 21±1||||1.0000
71046448|NCT02696031|141601210|SUPERIORITY||Odds Ratio (OR)|1.84||||0.0577|TWO_SIDED|95.0|0.98|3.45||unadjusted p-value|Regression, Logistic|||week 52|"Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight and baseline score as covariates.~Missing responses for any reason were imputed as non-responders. Patients were considered as non-responders after treatment switch decision."|3.45|0.98|0.0577
71046449|NCT02696031|141601210|SUPERIORITY||Odds Ratio (OR)|2.99||||0.0003|TWO_SIDED|95.0|1.65|5.41||unadjusted p-value|Regression, Logistic|||week 52|"Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight and baseline score as covariates.~Missing responses for any reason were imputed as non-responders. Patients were considered as non-responders after treatment switch decision."|5.41|1.65|0.0003
71046450|NCT02696031|141601211|SUPERIORITY||Relative Treatment Effect|0.7||||0.0002|TWO_SIDED|95.0|0.58|0.84||unadjusted p-value|MMRM|||week 16|Analysis was done on the log(e) ratio of the treatment value vs. baseline value to normalize the distribution of the hsCRP at each visit. LS Mean, SE, 95% CI and p-value were from mixed-effect model repeated measures (MMRM) with treatment, visit, stratification factor and TNFi status as factors, log(e) baseline and weight as covariates, treatment by visit and log(e) baseline by visit as interaction terms and an unstructured covariance|0.84|0.58|0.0002
71046451|NCT02696031|141601211|SUPERIORITY||Relative Treatment Effect|0.7||||0.0002||95.0|0.58|0.84||unadjusted p-value|MMRM|||week 16|Analysis was done on the log(e) ratio of the treatment value vs. baseline value to normalize the distribution of the hsCRP at each visit. LS Mean, SE, 95% CI and p-value were from mixed-effect model repeated measures (MMRM) with treatment, visit, stratification factor and TNFi status as factors, log(e) baseline and weight as covariates, treatment by visit and log(e) baseline by visit as interaction terms and an unstructured covariance structure.|0.84|0.58|0.0002
71046452|NCT02696031|141601212|SUPERIORITY||LS Mean of Treatment Difference|2.77|STANDARD_ERROR_OF_MEAN|0.799||0.0006|TWO_SIDED|95.0|1.2|4.34||unadjusted p-value|ANCOVA|||week 16|LS Mean, 95% CI, and p-value were from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|4.34|1.20|0.0006
71046453|NCT02696031|141601212|SUPERIORITY||LS Mean of Treatment Difference|2.64|STANDARD_ERROR_OF_MEAN|0.803||0.0011|TWO_SIDED|95.0|1.06|4.22||unadjusted p-value|ANCOVA|||week 16|LS Mean, 95% CI, and p-value were from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|4.22|1.06|0.0011
71046454|NCT02696031|141601213|SUPERIORITY||||||<|0.0001||||||unadjusted p-value|ANCOVA|||week 16|"LS Mean, 95% CI, and p-value were from an ANCOVA model with treatment group and stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates.~Missing data were imputed using multiple imputation (MI, MAR assumption) prior to running ANCOVA."|||<0.0001
71046455|NCT02696031|141601213|SUPERIORITY||||||<|0.0001||||||unadjusted p-value|ANCOVA|||week 16|"LS Mean, 95% CI, and p-value were from an ANCOVA model with treatment group and stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates.~Missing data were imputed using multiple imputation (MI, MAR assumption) prior to running ANCOVA."|||<0.0001
71046456|NCT02696031|141601214|SUPERIORITY||||||<|0.0001||||||unadjusted p-value|Wilcoxon (Mann-Whitney)|The endpoint was analyzed by composite estimand strategy. Extreme unfavorable value is assigned for patients with treatment escape or missing data.||||||<.0001
71046457|NCT02696031|141601214|SUPERIORITY||||||<|0.0001||||||unadjusted p-value|Wilcoxon (Mann-Whitney)|The endpoint was analyzed by composite estimand strategy. Extreme unfavorable value is assigned for patients with treatment escape or missing data.||||||<.0001
71046458|NCT03856593|141601227|SUPERIORITY||Slope|-0.14|STANDARD_ERROR_OF_MEAN|0.03|<|0.05|TWO_SIDED|95.0|-0.2|-0.07|||Mixed Models Analysis||This is the interaction coefficient for the difference-in-difference in average weekly MME pre-to-post letter between study arms. It was used to acquire the estimated average weekly MME post-letter in the Outcome Measure Data table.|Please note that 10% of means in the pre-intervention period were trimmed to remove outliers.||-0.07|-0.20|<0.05
71046459|NCT03856593|141601228|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.03|<|0.05|TWO_SIDED|95.0|-0.15|-0.02|||Mixed Models Analysis||This is the interaction coefficient for the difference-in-difference in average weekly MME pre-to-post letter between study arms. It was used to acquire the estimated average weekly VME post-letter in the Outcome Measure Data table.|||-0.02|-0.15|<0.05
71046460|NCT02994355|141601328|SUPERIORITY||Prevalence rate ratio|1.33|||<|0.05|TWO_SIDED|95.0|1.16|1.52|||Poisson Regression|||||1.52|1.16|<0.05
71046461|NCT02994355|141601329|SUPERIORITY||Prevalence rate ratio|1.27|||<|0.05|TWO_SIDED|95.0|1.15|1.3|||Poisson regression|||||1.30|1.15|<0.05
71046462|NCT02994355|141601330|SUPERIORITY||Prevalence rate ratio|3.23|||<|0.05|TWO_SIDED|95.0|2.29|4.55|||Poisson regression|||||4.55|2.29|<0.05
71046463|NCT03050918|141601331|SUPERIORITY|||||||0.05||||||we used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Wilcoxon (Mann-Whitney)|||||||.05
71046464|NCT03050918|141601332|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared|||||||0.05
71046465|NCT03050918|141601332|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Wilcoxon (Mann-Whitney)|||||||.05
71046466|NCT03050918|141601333|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared|||||||0.05
71046467|NCT03050918|141601333|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared|||||||.05
71046468|NCT03050918|141601334|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared|||||||.05
71010399|NCT03287960|141527780|OTHER|Two-sided confidence interval (CI) obtained using Clopper-Pearson method and one-sided p-value obtained from exact binomial test, testing that at least 5% of patients in the population of interest would achieve 10% weight loss.|||||<|0.0001|||||||Clopper-Pearson method|||||||<0.0001
71010400|NCT03287960|141527781|OTHER|Model based summary statistics from longitudinal mixed analysis of variance (ANOVA) model with fixed effect for visit, baseline body weight and random effect for participant, one sided p-value from model.|Least Squares Mean|-12.37|||<|0.0001|TWO_SIDED|90.0|-15.08|-9.66|||ANOVA|Longitudinal mixed ANOVA||||-9.66|-15.08|<.0001
71046469|NCT03050918|141601335|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Wilcoxon (Mann-Whitney)|||||||0.05
71046470|NCT03050918|141601336|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared|||||||0.05
71010401|NCT03287960|141527782|OTHER|Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for week, baseline daily hunger score and random effect for participant, one sided p-value from model.|Least Squares Mean|-42.69|||<|0.0001|TWO_SIDED|90.0|-56.35|-29.02|||ANOVA|Longitudinal mixed analysis of variance (ANOVA) model||||-29.02|-56.35|<.0001
71010402|NCT03287960|141527783|OTHER|Two-sided CI obtained using Clopper-Pearson method and one-sided p-value obtained from exact binomial test, testing that ≥5 % of participants in the population of interest would achieve ≥25 % improvement in daily hunger score.|||||<|0.0001|||||||Clopper-Pearson method|||||||<.0001
71010403|NCT03287960|141527784|OTHER|Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for visit, baseline waist circumference and random effect for participant, one sided p-value from model.|Least Squares Mean|-8.9||||0.0031|TWO_SIDED|90.0|-14.1|-3.61|||ANOVA|Longitudinal mixed ANOVA||||-3.61|-14.10|0.0031
71010404|NCT03287960|141527787|OTHER|Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for week, baseline BMI and random effect for participant, one sided p-value from model.|Least Squares Mean|-14.0|||<|0.0001|TWO_SIDED|90.0|-16.8|-11.2|||ANOVA|Longitudinal mixed ANOVA model||||-11.20|-16.80|<.0001
71010405|NCT00612573|141527798|SUPERIORITY_OR_OTHER||Mean Change from Baseline|-0.75|STANDARD_DEVIATION|0.85||0.779|TWO_SIDED|95.0|-14.8|10.3|||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||10.3|-14.8|0.779
71010406|NCT00612573|141527798|SUPERIORITY_OR_OTHER||Mean Change from Baseline|-0.69|STANDARD_DEVIATION|0.9||0.983|TWO_SIDED|95.0|-13.7|11.7|||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||11.7|-13.7|0.983
71010407|NCT00612573|141527798|SUPERIORITY_OR_OTHER||Mean Change from Baseline|-0.92|STANDARD_DEVIATION|0.97||0.087|TWO_SIDED|95.0|-1.5|27.3|||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||27.3|-1.5|0.087
71010408|NCT00612573|141527799|SUPERIORITY_OR_OTHER|||||||0.807||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.807
71010409|NCT00612573|141527799|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.075
71010410|NCT00612573|141527799|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.039
71010411|NCT00612573|141527800|SUPERIORITY_OR_OTHER|||||||0.212||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.212
71010412|NCT00612573|141527800|SUPERIORITY_OR_OTHER|||||||0.505||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.505
71010413|NCT00612573|141527800|SUPERIORITY_OR_OTHER|||||||0.399||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.399
71010414|NCT00612573|141527801|SUPERIORITY_OR_OTHER|||||||0.276||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.276
71010415|NCT00612573|141527801|SUPERIORITY_OR_OTHER|||||||0.231||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.231
71046471|NCT03050918|141601338|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared|||||||0.05
71010416|NCT00612573|141527801|SUPERIORITY_OR_OTHER|||||||0.081||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.081
71010417|NCT01425268|141527812|NON_INFERIORITY|Assuming that the success rate for both expanders was 95%, at least 92 breasts implanted with a AeroForm Tissue Expander and 46 breasts implanted with a saline expander were needed to be 80% confident (i.e., have a statistical power of 80%) that the lower bound of the one-sided 95% Confidence Interval for the difference in the Success rates (πTreatment - πControl) was greater than or equal to -10%.|margin of non-inferiority|-7.3|||||ONE_SIDED|95.0|-7.3241||||||The Treatment Success Rate per breast is 96.1% (149/155) for AeroForm and 98.8% (82/83) for saline.The difference (AeroForm - saline) is -2.7% with a lower confidence limit of -7.3%, meeting the non-inferiority margin of \> -10%.|The study was powered to show that the Treatment Success rate for the AeroForm System (πTreatment) was not worse than the rate for the saline expander (πControl) by more than 10% (-0.10 \< πTreatment - πControl).|||-7.3241|
71010418|NCT01425268|141527813|SUPERIORITY||||||<|0.0001|||||||Kaplan-Meier Log Rank test|Subjects not completing tissue expansion are censored in the analysis||||||<0.0001
71010419|NCT02257970|141527816|EQUIVALENCE|The likelihood of rejecting the null hypothesis (equivalence between the two groups) was defined as P\<0.05|||||<|0.0001|||||||t-test, 2 sided|paired t-test||For the analysis, the 4-month post-minus-pre change in this score for ketoprofen was compared.||||<0.0001
71010420|NCT02257970|141527817|EQUIVALENCE|Pre-to-post comparison: the likelihood of rejecting the null hypothesis (equivalence between the two groups) was defined as P\<0.05|||||=|0.6|||||||t-test, 2 sided|Paired t-test||||||=0.6
71010421|NCT02257970|141527817|EQUIVALENCE|Pre-to-Post comparison: The likelihood of rejecting the null hypothesis (equivalence between the two groups) was defined as P\<0.05|||||=|0.01|||||||t-test, 2 sided|paired t-test||||||=0.01
71046472|NCT03179163|141601435|OTHER||Mean Difference (Net)|0.01|||=|0.01|TWO_SIDED||||||ANOVA|||A priori power analysis (power = 0.80,a= 0.05) confirmed a sample size of n= 10 was needed to determine a meaningful difference of 10% in the (flux/MAP)\*logAch(mol/L) . All data were analyzed with repeated-measures ANOVA . When appropriate, post hoc Tukey-Kramer corrections were applied to correct for multiple comparisons. Significance was set a priori at a\<0.05.||||=0.01
71046473|NCT00775684|141601438|SUPERIORITY||||||=|0.1|||||||t-test, 2 sided|||Student t test||||=0.1
71046474|NCT00775684|141601438|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||Repeated measure (baseline and 6 months)||||< 0.05
71046475|NCT00775684|141601439|SUPERIORITY||||||>|0.1|||||||t-test, 1 sided|||Within group changes over 6 months (delta= final - baseline) were compared.||||>0.1
70928578|NCT04800211|141353077|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-178.789|||<|0.0001|TWO_SIDED|95.0|-204.899|-152.678|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-152.678|-204.899|<.0001
71010422|NCT01716585|141527854|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical SVR rates for noncirrhotic HCV treatment-naive subjects administered telaprevir plus peginterferon (pegIFN)/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 70% to achieve noninferiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV, and the LCB of the 95% CI must have exceeded 80% to achieve superiority.|Percentage of Participants with SVR12|96.4|||||TWO_SIDED|95.0|94.7|98.1|||||In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure was used to proceed through the primary and first 3 secondary efficacy endpoints in the order numbered below.|With a sample size of 450 subjects and assuming that 92% of the subjects in Arm A will achieve SVR12, this study has greater than 90% power to demonstrate non-inferiority with a 2-sided 95% lower confidence bound greater than 70% and greater than 90% power to demonstrate superiority with a 2-sided 95% lower confidence bound greater than 80% (based on the normal approximation of a single binomial proportion). 95% CI calculated using the normal approximation to the binomial distribution.||98.1|94.7|
71010423|NCT01716585|141527855|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure will be used to proceed through the primary and first 3 secondary efficacy endpoints in the order numbered below.|Fisher Exact|||||||< 0.001
71046476|NCT00775684|141601440|SUPERIORITY||||||>|0.1|||||||t-test, 1 sided|||To determine if exenatide or sitagliptin induced significant changes from baseline, the change for each measure (Δ = final - baseline) for each group was compared with the change in the glimepiride group using independent Student t tests||||>0.1
71046477|NCT00775684|141601441|SUPERIORITY||||||>|0.1|||||||t-test, 1 sided|||||||>0.1
71046478|NCT01277718|141601443|SUPERIORITY_OR_OTHER||Ratio of Least Squares (LS) Means (in %)|111.0|||||TWO_SIDED|90.0|98.02|124.99|||||LS mean was calculated from Analysis of variance (ANOVA). Data for AUCinf were natural log-transformed prior to analysis. Ratio of AUCinf LS means for log-transformed parameter (expressed as a percent).|||124.99|98.02|
71046479|NCT01277718|141601443|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|96.2|||||TWO_SIDED|90.0|85.06|108.77|||||LS mean was calculated from ANOVA. Data for AUCinf were natural log-transformed prior to analysis. Ratio of AUCinf LS means for log-transformed parameter (expressed as a percent).|||108.77|85.06|
71046480|NCT01277718|141601443|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|106.0|||||TWO_SIDED|90.0|94.53|119.91|||||LS mean was calculated from ANOVA. Data for AUCinf were natural log-transformed prior to analysis. Ratio of AUCinf LS means for log-transformed parameter (expressed as a percent).|||119.91|94.53|
71046481|NCT01277718|141601444|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|100.0|||||TWO_SIDED|90.0|85.09|118.03|||||LS mean was calculated from ANOVA. Data for Cmax were natural log-transformed prior to analysis. Ratio of Cmax LS means for log-transformed parameter (expressed as a percent).|||118.03|85.09|
71046482|NCT01277718|141601444|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|85.7|||||TWO_SIDED|90.0|72.51|101.33|||||LS mean was calculated from ANOVA. Data for Cmax were natural log-transformed prior to analysis. Ratio of Cmax LS means for log-transformed parameter (expressed as a percent).|||101.33|72.51|
71046483|NCT01277718|141601444|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|85.9|||||TWO_SIDED|90.0|72.94|101.17|||||LS mean was calculated from ANOVA. Data for Cmax were natural log-transformed prior to analysis. Ratio of Cmax LS means for log-transformed parameter (expressed as a percent).|||101.17|72.94|
71046484|NCT02858726|141601490|SUPERIORITY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-2.8|-0.8|||Mixed Models Analysis|MMRM with effects for treatment, visit, treatment by visit interaction, and covariates for prior anti-itch medication usage and baseline score.||||-0.8|-2.8|<0.001
71046485|NCT02858726|141601490|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.5||0.107|TWO_SIDED|95.0|-1.9|0.2|||Mixed Models Analysis|MMRM with effects for treatment, visit, treatment by visit interaction, and covariates for prior anti-itch medication usage and baseline score.||||0.2|-1.9|0.107
71046486|NCT02858726|141601490|SUPERIORITY||Median Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.5||0.019|TWO_SIDED|95.0|-2.3|-0.2|||Mixed Models Analysis|MMRM with effects for treatment, visit, treatment by visit interaction, and covariates for prior anti-itch medication usage and baseline score.||||-0.2|-2.3|0.019
71046487|NCT02858726|141601491|SUPERIORITY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-16.0|-4.8|||Mixed Models Analysis|MMRM with effects for treatment, visit, treatment by visit interaction, and covariates for prior anti-itch medication usage and baseline score.||||-4.8|-16.0|<0.001
71046488|NCT02858726|141601491|SUPERIORITY||Mean Difference (Final Values)|-7.2|STANDARD_ERROR_OF_MEAN|3.0||0.016|TWO_SIDED|95.0|-13.1|-1.4|||Mixed Models Analysis|MMRM with effects for treatment, visit, treatment by visit interaction, and covariates for prior anti-itch medication usage and baseline score.||||-1.4|-13.1|0.016
71046489|NCT02858726|141601491|SUPERIORITY||Mean Difference (Final Values)|-6.8|STANDARD_ERROR_OF_MEAN|3.0||0.026|TWO_SIDED|95.0|-12.8|-0.8|||Mixed Models Analysis|MMRM with effects for treatment, visit, treatment by visit interaction, and covariates for prior anti-itch medication usage and baseline score.||||-0.8|-12.8|0.026
71046490|NCT00518622|141601501|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.01||||||95.0|-2.87|-1.14|||||Mean (Day 8 - baseline) HCV RNA for MK7009 25 mg bid minus mean (Day 8 - baseline) HCV RNA for placebo|||-1.14|-2.87|
71046491|NCT00518622|141601501|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.64||||||95.0|-3.49|-1.8|||||Mean (Day 8 - baseline) HCV RNA for MK7009 75 mg bid minus mean (Day 8 - baseline) HCV RNA for placebo|||-1.80|-3.49|
70928579|NCT04800211|141353077|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-184.391|||<|0.0001|TWO_SIDED|95.0|-211.184|-157.598|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-157.598|-211.184|<.0001
71010424|NCT01716585|141527856|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical SVR rates for noncirrhotic HCV treatment-naive subjects of the appropriate HCV genotype 1 subtype administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 75% to achieve superiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV.|Percentage of Participants with SVR12|95.7|||||TWO_SIDED|95.0|93.4|97.9||In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure will be used to proceed through the primary and first 3 secondary efficacy endpoints in the order numbered below.|||95% CI calculated using the normal approximation to the binomial distribution.|||97.9|93.4|
71010425|NCT01716585|141527857|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical SVR rates for noncirrhotic HCV treatment-naive subjects of the appropriate HCV genotype 1 subtype administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 84% to achieve superiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV.|Percentage of Participants with SVR12|98.0|||||TWO_SIDED|95.0|95.8|100.0|||||95% CI calculated using the normal approximation to the binomial distribution.|||100.0|95.8|
71010426|NCT00851721|141527869|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0|||||Two-sample, two-sided t-test|||H0: μ(on-demand) = μ(prophylaxis) Versus H1: μ(on-demand) ≠ μ(prophylaxis) (Where H0 implies no difference in mean bleeding episode rate between prophylaxis and on-demand treatment arms and H1 implies otherwise. This test was performed at a significance level of 5%, two-sided, two sample)||||0.0003
71010427|NCT00851721|141527871|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008|||||||Two-sample, two-sided t-test|||Spontaneous Bleeds||||0.0008
71010428|NCT00851721|141527871|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0199|||||||Two-sample, two-sided t-test|||Traumatic Bleeds||||0.0199
71010429|NCT00851721|141527871|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006|||||||Two-sample, two-sided t-test|||Joint Bleeds||||0.0006
71010430|NCT00851721|141527871|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0227|||||||Two-sample, two-sided t-test|||Non-Joint Bleeds||||0.0227
71010431|NCT00851721|141527871|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0013|||||||Two-sample, two-sided t-test|||Spontaneous Joint Bleeds||||0.0013
71010432|NCT00851721|141527871|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||Two-sample, two-sided t-test|||Spontaneous Non-Joint Bleeds||||0.0030
71046492|NCT00518622|141601501|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9||||||95.0|-3.9|-1.9|||||Mean (Day 8 - baseline) HCV RNA for MK7009 250 mg bid minus mean (Day 8 - baseline) HCV RNA for placebo|||-1.90|-3.90|
71046493|NCT00518622|141601501|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.38||||||95.0|-4.59|-2.17|||||Mean (Day 8 - baseline) HCV RNA for MK7009 500 mg bid minus mean (Day 8 - baseline) HCV RNA for placebo|||-2.17|-4.59|
71010433|NCT00851721|141527871|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0254|||||||Two-sample, two-sided t-test|||Traumatic Joint Bleeds||||0.0254
71010434|NCT00851721|141527871|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9322|||||||Two-sample, two-sided t-test|||Traumatic Non-Joint Bleeds||||0.9322
71010435|NCT00851721|141527873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0271|||||||Two-sample, two-sided t-test|||||||0.0271
71010436|NCT00851721|141527880|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0067||95.0|||||Mann-Whitney tests (Wilcoxon-Rank Sum)|||||||0.0067
71010437|NCT03485976|141527919|OTHER||||||<|0.001||||||The threshold for statistical significance was p=0.05|t-test, 2 sided|||||||<0.001
71010438|NCT03485976|141527920|OTHER|||||||0.004||||||The threshold for significance was p=0.05|t-test, 2 sided|||||||0.004
71010439|NCT03485976|141527921|OTHER|||||||0.001||||||Threshold for significance was p=0.05|t-test, 2 sided|||||||0.001
71010440|NCT03451630|141527922|SUPERIORITY|||||||0.0211||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 2.49 with degrees of freedom (6, 3152).||Overall Test of Group by Time Interaction||||0.0211
71046494|NCT00518622|141601501|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.73||||||95.0|-5.15|-4.31|||||Mean (Day 8 - baseline) HCV RNA for MK7009 700 mg bid minus mean (Day 8 - baseline) HCV RNA for placebo|||-4.31|-5.15|
71046495|NCT00518622|141601501|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.93||||||95.0|-2.68|-1.18|||||Mean (Day 8 - baseline) HCV RNA for MK7009 125 mg qd minus mean (Day 8 - baseline) HCV RNA for placebo|||-1.18|-2.68|
71046496|NCT00518622|141601501|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.46||||||95.0|-2.78|-2.13|||||Mean (Day 8 - baseline) HCV RNA for MK7009 600 mg qd minus mean (Day 8 - baseline) HCV RNA for placebo|||-2.13|-2.78|
71046497|NCT01036490|141601505|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
71046498|NCT01036490|141601506|SUPERIORITY_OR_OTHER|||||||0.39|||||||t-test, 2 sided|||||||0.39
71046499|NCT01036490|141601509|SUPERIORITY_OR_OTHER|||||||0.15|||||||t-test, 2 sided|||||||0.15
70928580|NCT04800211|141353077|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-175.1|||<|0.0001|TWO_SIDED|95.0|-200.964|-149.237|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-149.237|-200.964|<.0001
70928581|NCT04800211|141353077|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-161.576|||<|0.0001|TWO_SIDED|95.0|-187.543|-135.609|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-135.609|-187.543|<.0001
70928582|NCT04800211|141353077|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-172.983|||<|0.0001|TWO_SIDED|95.0|-192.08|-153.886|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-153.886|-192.080|<.0001
70928583|NCT04800211|141353077|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-3.585||||0.7781|TWO_SIDED|95.0|-28.572|21.401|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||21.401|-28.572|0.7781
70928584|NCT04800211|141353077|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-7.764||||0.5457|TWO_SIDED|95.0|-32.993|17.465|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||17.465|-32.993|0.5457
70928585|NCT04800211|141353077|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-175.203|||<|0.0001|TWO_SIDED|95.0|-220.445|-129.961|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-129.961|-220.445|<.0001
71010441|NCT03451630|141527922|SUPERIORITY||Mean Difference (Final Values)|2.69|STANDARD_ERROR_OF_MEAN|1.22||0.028|TWO_SIDED|95.0|0.29|5.09||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 4.83 with degrees of freedom (1, 3152).||Test for group difference in the change from baseline to 12-Months using linear contrast.||5.09|0.29|0.0280
71010442|NCT03451630|141527922|SUPERIORITY||Mean Difference (Final Values)|2.07|STANDARD_ERROR_OF_MEAN|1.23||0.0935|TWO_SIDED|95.0|-0.35|4.48||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 2.81 with degrees of freedom (1, 3152).||Test for group difference in the change from baseline to 12-Months using linear contrast.||4.48|-0.35|0.0935
71046500|NCT01036490|141601510|SUPERIORITY_OR_OTHER|||||||0.58|||||||t-test, 2 sided|||||||0.58
71010443|NCT03451630|141527922|SUPERIORITY||Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|1.05||0.5538|TWO_SIDED|95.0|-1.44|2.68||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.35 with degrees of freedom (1, 3152).||Test for group difference in the change from baseline to12-Months using linear contrast.||2.68|-1.44|0.5538
71010444|NCT03451630|141527923|SUPERIORITY|Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).||||||0.8505|||||||Mixed Models Analysis|F-statistics 0.44 with degrees of freedom (6, 3154).||Overall Test of the Group by Time Interaction||||0.8505
71010445|NCT03451630|141527923|SUPERIORITY||||||<|0.0001||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 16.97 with degrees of freedom (3, 3160).||Test for significant change over time when the treatment-by-time interaction effect is not significant.||||<0.0001
71010446|NCT03451630|141527923|SUPERIORITY|||||||0.8656||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.14 with degrees of freedom (2, 1229).||Test for significant change by treatment when the treatment-by-time interaction effect is not significant.||||0.8656
71010447|NCT03451630|141527923|SUPERIORITY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|1.29||0.474|TWO_SIDED|95.0|-1.61|3.46||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.51 with degrees of freedom (1, 3154)||Test for group difference in the change from baseline to 12-Months using the linear contrasts.||3.46|-1.61|0.4740
71010448|NCT03451630|141527923|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|1.26||0.6017|TWO_SIDED|95.0|-1.81|3.13||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.27 with degrees of freedom (1, 3154).||Test for group difference in the change from baseline to 12-Months using the linear contrasts.||3.13|-1.81|0.6017
71010449|NCT03451630|141527923|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.99||0.786|TWO_SIDED|95.0|-1.67|2.2||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.07 with degrees of freedom (1, 3154).||Test for group difference in the change from baseline to 12-Months using the linear contrasts.||2.20|-1.67|0.7860
71010450|NCT03451630|141527924|SUPERIORITY|||||||0.59||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.08 with degrees of freedom (2).||Overall Test of Marginal Group Differences||||0.59
71010451|NCT03451630|141527924|SUPERIORITY||Odds Ratio (OR)|1.26||||0.6692|TWO_SIDED|95.0|0.76|2.11||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-square statistics 0.8 with degrees of freedom (2).||Test for the Treatment Effect||2.11|0.76|0.6692
71010452|NCT03451630|141527924|SUPERIORITY||Odds Ratio (OR)|1.16||||0.6692|TWO_SIDED|95.0|0.7|1.93||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-square statistics 0.80 with degrees of freedom (2).||Test for the Treatment Effect||1.93|0.70|0.6692
71010453|NCT03451630|141527924|SUPERIORITY||Odds Ratio (OR)|1.09||||0.6692|TWO_SIDED|95.0|0.75|1.59||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-square statistics 0.8 with degrees of freedom (2).||Test for the Treatment Effect||1.59|0.75|0.6692
71046501|NCT00603291|141601511|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.14|||<|0.0001|TWO_SIDED|95.0|2.05|4.8|||Regression, Logistic|Adjustment for baseline body weight, baseline HbA1c stratum, and prior antihyperglycemic medication stratum||||4.80|2.05|<0.0001
71046502|NCT00603291|141601512|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.06|||<|0.0001|TWO_SIDED|95.0|-3.92|-2.2|||ANCOVA|||||-2.20|-3.92|<0.0001
71046503|NCT02177136|141601536|SUPERIORITY|||||||0.0434|||||||ANCOVA|ANCOVA model with treatment group and randomization stratification factors as fixed effects and baseline as covariate.||||||0.0434
71046504|NCT02177136|141601536|SUPERIORITY|||||||0.0665|||||||ANCOVA|ANCOVA model with treatment group and randomization stratification factors as fixed effects and baseline as covariate.||||||0.0665
71046505|NCT03197558|141601602|SUPERIORITY|Upper confidence limit of mean VAS score hypothesized to be less than (superior) to a performance goal of 45 mm.|Bootstrap method|14.35|||||ONE_SIDED|97.5||14.35||||||Mean VAS score compared to performance goal using a bootstrap method test at 2.5% significance.||14.35||
71077848|NCT02913105|141664396|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.99||||0.664|TWO_SIDED|90.0|0.97|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||1.02|0.97|0.6640
71103667|NCT02507934|141714875|SUPERIORITY|||||||0.3165|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Right - Day 21±1||||0.3165
71010454|NCT03451630|141527925|SUPERIORITY|||||||0.58||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.08 with degrees of freedom (2).||Overall Test of Marginal Group Differences||||0.58
71010455|NCT03451630|141527925|SUPERIORITY||Odds Ratio (OR)|1.13||||0.7436|TWO_SIDED|95.0|0.43|3.02||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.59 with degrees of freedom (2).||Test for the treatment effect||3.02|0.43|0.7436
71010456|NCT03451630|141527925|SUPERIORITY||Odds Ratio (OR)|0.84||||0.7436|TWO_SIDED|95.0|0.31|2.25||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.59 with degrees of freedom (2).||Test for the treatment effect.||2.25|0.31|0.7436
71010457|NCT03451630|141527925|SUPERIORITY||Odds Ratio (OR)|1.36||||0.7436|TWO_SIDED|95.0|0.62|2.97|||Regression, Logistic|Chi-squared statistics 0.59 with degrees of freedom (2).||Test for the treatment effect.||2.97|0.62|0.7436
71010458|NCT03451630|141527926|SUPERIORITY|||||||0.5558||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.82 with degrees of freedom (6, 3057)||Overall test of treatment-by-time interaction||||0.5558
71010459|NCT03451630|141527926|SUPERIORITY|||||||0.0002||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 6.74 with degrees of freedom (3, 3063).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||0.0002
71010460|NCT03451630|141527926|SUPERIORITY|||||||0.7846||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.24 with degrees of freedom (2,1197).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.7846
71010461|NCT03451630|141527926|SUPERIORITY||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.61||0.2444|TWO_SIDED|95.0|-1.92|0.49||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-Statistics 1.36 with degrees of freedom (1, 3057).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.49|-1.92|0.2444
71010462|NCT03451630|141527926|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.61||0.648|TWO_SIDED|95.0|-1.48|0.92||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.21 with degrees of freedom (1, 3057).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.92|-1.48|0.6480
71010463|NCT03451630|141527926|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.46||0.3476|TWO_SIDED|95.0|-1.34|0.47||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.88 with degrees of freedom (1, 3057).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.47|-1.34|0.3476
71010464|NCT03451630|141527927|SUPERIORITY|||||||0.5199||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.86 with degrees of freedom (6, 3148)||Overall test of treatment-by-time||||0.5199
71010465|NCT03451630|141527927|SUPERIORITY|||||||0.0008||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 5.56 with degrees of freedom (3, 3154).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||0.0008
71010466|NCT03451630|141527927|SUPERIORITY|||||||0.9897||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.01 with degrees of freedom (2,1229).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.9897
71010467|NCT03451630|141527927|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.8749|TWO_SIDED|95.0|-0.03|0.03||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.02 with degrees of freedom (1, 3148).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.03|-0.03|0.8749
71010468|NCT03451630|141527927|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.01||0.2216|TWO_SIDED|95.0|-0.05|0.01||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.49 with degrees of freedom (1, 3148).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.01|-0.05|0.2216
71010469|NCT03451630|141527927|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.0607|TWO_SIDED|95.0|0.0|0.04||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 3.52 with degrees of freedom (1, 3148).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.04|0.00|0.0607
71010470|NCT03451630|141527928|SUPERIORITY|||||||0.1884||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.46 with degrees of freedom (6, 3138)||Overall test of treatment-by-time||||0.1884
71010471|NCT03451630|141527928|SUPERIORITY|||||||0.009||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 3.87 with degrees of freedom (3, 3144).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||0.0090
71010472|NCT03451630|141527928|SUPERIORITY|||||||0.217||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.53 with degrees of freedom (2, 1227).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.2170
71010473|NCT03451630|141527928|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.09||0.191|TWO_SIDED|95.0|-0.06|0.28||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.71 with degrees of freedom (1, 3138).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.28|-0.06|0.1910
71010474|NCT03451630|141527928|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.08||0.0229|TWO_SIDED|95.0|0.03|0.35||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 5.18 with degrees of freedom (1, 3138).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.35|0.03|0.0229
71010475|NCT03451630|141527928|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.2547|TWO_SIDED|95.0|-0.21|0.06||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.30 with degrees of freedom (1, 3138).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.06|-0.21|0.2547
71010476|NCT03451630|141527929|SUPERIORITY|||||||0.0413||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 2.49 with degrees of freedom (4, 3164).||Overall test for the treatment-by-time interaction||||0.0413
71046506|NCT02274844|141601638|SUPERIORITY|The outcomes were all continuous or ordinal measures, thus unadjusted hypothesis tests used t-tests or the Wilcoxon-Mann-Whitney test, as appropriate, and statistical modeling used linear regression. ANCOVA was used to adjust for baseline covariates with imbalance across treatment arms (race) and baseline values of the measures.|Mean Difference (Final Values)|-0.09||||0.22|TWO_SIDED|95.0|-0.23|0.05||The main hypotheses tested were that intervention participants would have higher medication adherence and significantly greater improvement in A1c, BP, LDL-C, and measures of quality of life, and self-efficacy compared to control participants.|ANCOVA|||The study was powered to detect clinically meaningful differences in physiologic risk factors; it had four primary outcomes.Power estimates accounted for clustering of patients within towns, using a variance inflation factor, conservatively estimating power for ICC=0.01-0.05. Process measures were selected to understand which aspects of the intervention were particularly effective, assessing both program satisfaction and peer coach effectiveness.||0.05|-0.23|0.22
71046507|NCT03463993|141601665|SUPERIORITY|||||||0.549||||||The p-value above is the calculated P value based on hematocrit.|Chi-squared|||The null hypothesis was that intravenous Tranexamic Acid (TXA) 10mg/kg plus Oxytocin 5IU does not result in a lower incidence of primary postpartum haemorrhage compared to Oxytocin alone after elective caesarean section||||0.549
71046508|NCT03463993|141601665|SUPERIORITY|||||||0.138||||||This is the calculated p-value based on hemoglobin .|Chi-squared|||The null hypothesis was that intravenous Tranexamic Acid (TXA)10mg/kg plus Oxytocin 5IU does not result in a lower incidence of primary postpartum haemorrhage compared to Oxytocin alone after elective caesarean section||||0.138
71046509|NCT03463993|141601666|SUPERIORITY|||||||0.789||||||0.789 is the calculated p-value for visually estimated blood loss: Visually estimated blood loss (ml): Group A mean 483.73 (standard deviation182.56); Group B 479.61 (139.49); p-value 0.789|t-test, 2 sided|||||||0.789
71046510|NCT03463993|141601666|SUPERIORITY|||||||0.968||||||0.968 is the calculated p-value based on hematocrit. Hematocrit-based calculation of estimated blood loss(ml): Group A mean 650.06 (standard deviation 631.50); Group B 653.05 (796.03); p-value 0.968|t-test, 2 sided|||||||0.968
70941344|NCT00924833|141383253|SUPERIORITY_OR_OTHER|||||||0.93||||||Within subjects effects. Time: p = 0.03. Time \* treatment: p = 0.12.|ANOVA|||"Differences among groups, changes over time and interactions: two-way repeated measures ANOVA with unpaired Student's t-test, Bonferroni correction.~No previous studies have compared carvedilol, nebivolol, and placebo with respecto to exercise performance in hypobaric hypoxia. The sample size set for each treatment arm was defined on the basis of the sample size of previous investigations showing significant changes in exercise performance in normal subjects."||||0.93
71010477|NCT03451630|141527929|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.08||0.1433|TWO_SIDED|95.0|-0.28|0.04||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 2.14 with degrees of freedom (1, 3164).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.04|-0.28|0.1433
71010478|NCT03451630|141527929|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.4272|TWO_SIDED|95.0|-0.1|0.23||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.63 with degrees of freedom (1, 3164).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.23|-0.10|0.4272
71010479|NCT03451630|141527929|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.06||0.0037|TWO_SIDED|95.0|-0.31|-0.06||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 8.45 with degrees of freedom (1, 3164).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||-0.06|-0.31|0.0037
71010480|NCT03451630|141527930|SUPERIORITY|||||||0.8231||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.38 with degrees of freedom (4, 3164).||Overall test for the treatment-by-time interaction||||0.8231
71010481|NCT03451630|141527930|SUPERIORITY||||||<|0.0001||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 330.05 with degrees of freedom (2, 1948).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||<0.0001
71010482|NCT03451630|141527930|SUPERIORITY|||||||0.6061||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.50 with degrees of freedom (2 , 1948).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.6061
71010483|NCT03451630|141527930|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.7459|TWO_SIDED|95.0|-0.15|0.11||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.11 with degrees of freedom (1, 3164).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.11|-0.15|0.7459
71010484|NCT03451630|141527930|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.3169|TWO_SIDED|95.0|-0.18|0.08||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.00 with degrees of freedom (1, 3164).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.08|-0.18|0.3169
71010485|NCT03451630|141527930|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.04||0.4098|TWO_SIDED|95.0|-0.07|0.14||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.68 with degrees of freedom (1, 3164).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.14|-0.07|0.4098
71046511|NCT03463993|141601666|SUPERIORITY|||||||0.447||||||Hemoglobin-based calculation of estimated blood loss(ml) mean(standard deviation): Group A 644.30 (692.27); Group B 707.68 (948.01); p-value 0.447|t-test, 2 sided|||||||0.447
71046512|NCT03463993|141601667|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71046513|NCT03463993|141601668|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
71046514|NCT05528861|141601721|SUPERIORITY||LSM Difference from Placebo|0.5|STANDARD_ERROR_OF_MEAN|2.1||0.8174|TWO_SIDED|95.0|-3.6|4.5|||ANCOVA|||||4.5|-3.6|0.8174
71046515|NCT05528861|141601722|SUPERIORITY||LSM Difference from Placebo|0.6|STANDARD_ERROR_OF_MEAN|1.1||0.5857|TWO_SIDED|95.0|-1.6|2.8|||Mixed Models Analysis|||||2.8|-1.6|0.5857
71046516|NCT05528861|141601723|SUPERIORITY||LSM Difference from Placebo|-0.1|STANDARD_ERROR_OF_MEAN|1.1||0.9633|TWO_SIDED|95.0|-2.2|2.1|||Mixed Models Analysis|||||2.1|-2.2|0.9633
71046517|NCT05528861|141601724|SUPERIORITY||Risk Difference (RD)|6.25||||0.1201|TWO_SIDED|95.0|-11.4|23.78|||Fisher Exact|||||23.78|-11.40|0.1201
71077849|NCT02913105|141664396|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.7517|TWO_SIDED|90.0|0.98|1.03|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||1.03|0.98|0.7517
71046518|NCT01602172|141601727|EQUIVALENCE|Results of the regression models were used to reject null hypotheses of equivalence with p-values of comparisons across groups in changes in alcohol related measures using p-values \< 0.05 as significant.||||||0.05||||||First, significance of the regression model was viewed. When the overall model was significant, tests of the co-efficients were viewed. Primary effects of interest were the treatment group X time interactions.|Mixed Models Analysis|||Measures were compared with linear mixed effects regression models to compare impact of BI compared to usual care conditions. Analyses reported here included only those that completed the 6 month interview (71/82 baseline participants).||||.05
71046519|NCT02654587|141601732|SUPERIORITY||Hazard Ratio (HR)|0.59|||<|0.05|TWO_SIDED|95.0|0.38|0.91||OS in patients with ICI secondary resistance|t-test, 2 sided||p=0.017|||0.91|0.38|<0.05
71046520|NCT02654587|141601732|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.36|TWO_SIDED|95.0|0.62|1.19|||t-test, 2 sided|||OS in the ITT population with ICI resistance (primary and secondary resistance)||1.19|0.62|0.36
71046521|NCT02654587|141601733|SUPERIORITY||Hazard Ratio (HR)|0.46||||0.004|TWO_SIDED|95.0|0.27|0.79|||t-test, 2 sided|||Post-progression survival in patients with ICI secondary resistance||0.79|0.27|0.004
71046522|NCT02654587|141601733|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.0035|TWO_SIDED|95.0|0.39|0.83|||t-test, 2 sided|||Post-progression survival in ITT population with ICI resistance (primary and secondary)||0.83|0.39|0.0035
71046523|NCT02654587|141601734|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.006|TWO_SIDED|95.0|0.23|0.8|||t-test, 2 sided|||Time to worsening ECOG PS \>1 in patients with ICI secondary resistance||0.80|0.23|0.006
71046524|NCT02654587|141601734|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.02|TWO_SIDED|95.0|0.35|0.92|||t-test, 2 sided|||Time to worsening ECOG PS in the ITT population with ICI resistance (primary and secondary)||0.92|0.35|0.02
71046525|NCT02654587|141601735|SUPERIORITY||P Value|0.045|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||QLQ C30 Global Health Status in Patients with ICI secondary resistance||||<0.05
71046526|NCT02654587|141601735|SUPERIORITY||P Value|0.07||||0.07|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Physical functioning in patients with ICI secondary resistance||||0.07
71046527|NCT02654587|141601735|SUPERIORITY||P Value|0.03|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Role functioning in patients with ICI secondary resistance||||<0.05
71046528|NCT02654587|141601735|SUPERIORITY||P Value|0.36||||0.36|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Emotional functioning in patients with ICI secondary resistance||||0.36
71046529|NCT02654587|141601735|SUPERIORITY||P Value|0.24||||0.24|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Cognitive functioning in patients with ICI secondary resistance||||0.24
71046530|NCT02654587|141601735|SUPERIORITY|QLQ-C30 Social functioning|P Value|0.11||||0.11|TWO_SIDED||||||Mixed Models Analysis|||||||0.11
71046531|NCT02654587|141601736|SUPERIORITY||P Value|0.06||||0.06|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Fatigue in ICI secondary resistance||||0.06
71046532|NCT02654587|141601736|SUPERIORITY||P Value|0.0003||||0.0003|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Constipation in ICI secondary resistance||||0.0003
71046533|NCT02654587|141601736|SUPERIORITY||P Value|0.8||||0.8|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Dyspnea in ICI secondary resistance||||0.80
71046534|NCT02654587|141601736|SUPERIORITY||P Value|0.21||||0.21|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Nausea and Vomiting in ICI secondary resistance||||0.21
71046535|NCT02654587|141601736|SUPERIORITY||P Value|0.45||||0.45|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Pain in ICI secondary resistance||||0.45
71046536|NCT02654587|141601736|SUPERIORITY||P Value|0.87||||0.87|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Insomnia in ICI secondary resistance||||0.87
71046537|NCT02654587|141601736|SUPERIORITY||P Value|0.59||||0.59|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Appetite loss in ICI secondary resistance||||0.59
71046538|NCT02654587|141601736|SUPERIORITY||P Value|0.88||||0.88|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Diarrhea in ICI secondary resistance||||0.88
71046539|NCT02654587|141601736|SUPERIORITY||P Value|0.37||||0.37|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Financial difficulties in ICI secondary resistance||||0.37
71046540|NCT02654587|141601737|SUPERIORITY||P Value|0.0001|||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC13 Alopecia in ICI secondary resistance||||<0.0001
71046541|NCT02654587|141601737|SUPERIORITY||P Value|0.03||||0.03|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC 13 Peripheral neuropathy in ICI secondary resistance||||0.03
71046542|NCT02654587|141601737|SUPERIORITY||P Value|0.01||||0.01|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC13 Sore mouth in ICI secondary resistance||||0.01
71046543|NCT02654587|141601737|SUPERIORITY||P Value|0.01||||0.01|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC13 Dysphagia in ICI secondary resistance||||0.01
71046544|NCT02654587|141601737|SUPERIORITY||P Value|0.35||||0.35|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC13 Pain in arm and shoulder||||0.35
71046545|NCT02654587|141601737|SUPERIORITY||P Value|0.43||||0.43|TWO_SIDED||||||Mantel Haenszel|||QLQ-LC13 Pain in chest in ICI secondary resistance||||0.43
71046546|NCT02654587|141601737|SUPERIORITY||P Value|0.78||||0.78|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC13 Pain in other parts||||0.78
71046547|NCT02654587|141601737|SUPERIORITY||P Value|0.23||||0.23|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC 13 Hemoptysis in ICI secondary resistance||||0.23
71046548|NCT02654587|141601737|SUPERIORITY||P Value|0.54||||0.54|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC13 Coughing in ICI secondary resistance||||0.54
71046549|NCT02654587|141601738|SUPERIORITY||Odds Ratio (OR)|1.09||||0.87|TWO_SIDED|95.0|0.43|2.75|||Mantel Haenszel|||DCR at 6 months in patients with ICI secondary resistance||2.75|0.43|0.87
71046550|NCT02654587|141601738|SUPERIORITY||Odds Ratio (OR)|0.73||||0.37|TWO_SIDED|95.0|0.36|1.46|||Mantel Haenszel|||DCR at 6 months in ITT patients with ICI resistance (primary and secondary)||1.46|0.36|0.37
71046551|NCT02654587|141601739|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.29|TWO_SIDED|95.0|0.82|2.0|||t-test, 2 sided|||Median PFS in patients with ICI secondary resistance||2.0|0.82|0.29
71046552|NCT02654587|141601739|SUPERIORITY||Hazard Ratio (HR)|1.64|||<|0.05|TWO_SIDED|95.0|1.18|2.28|||t-test, 2 sided|||Median PFS in ITT patients with ICI resistance (primary and secondary)||2.28|1.18|<0.05
71046553|NCT02654587|141601740|SUPERIORITY|ORR in ICI secondary resistance|Odds Ratio (OR)|0.33||||0.07|TWO_SIDED|95.0|0.1|1.11|||Mantel Haenszel|||||1.11|0.10|0.07
71046554|NCT02654587|141601740|SUPERIORITY|ORR in ITT population with ICI resistance (primary and secondary)|Odds Ratio (OR)|0.22||||0.002|TWO_SIDED|95.0|0.08|0.59|||Mantel Haenszel|||||0.59|0.08|0.002
71046555|NCT02654587|141601741|SUPERIORITY|Duration of response at 6 months in ICI secondary resistance|Hazard Ratio (HR)|1.14||||0.88|TWO_SIDED|95.0|0.25|5.3|||Regression, Cox|||||5.30|0.25|0.88
70941345|NCT00924833|141383256|SUPERIORITY_OR_OTHER||||||<|0.05||||||ANOVA with unpaired Student's t-test, Bonferroni correction. Bonferroni correction. p = 0.05.|ANOVA|||No previous studies have compared carvedilol, nebivolol, and placebo with respecto to exercise performance in hypobaric hypoxia. The sample size set for each treatment arm was defined on the basis of the sample size of previous investigations showing significant changes in exercise performance in normal subjects.||||<0.05
71046556|NCT02654587|141601741|SUPERIORITY|Duration of Response at 6 months in ITT population with ICI resistance (primary and secondary)|Hazard Ratio (HR)|1.41||||0.57|TWO_SIDED|95.0|0.43|4.6|||Regression, Cox|||||4.60|0.43|0.57
71046557|NCT02654587|141601742|SUPERIORITY|Time to next lung cancer therapy in ICI secondary resistance|Hazard Ratio (HR)|1.85||||0.04|TWO_SIDED|95.0|1.03|3.31|||Regression, Cox|||||3.31|1.03|0.04
71046558|NCT02654587|141601742|SUPERIORITY|Time to next lung cancer therapy in ITT population with ICI resistance (primary and secondary)|Hazard Ratio (HR)|1.59||||0.02|TWO_SIDED|95.0|1.07|2.36|||Regression, Cox|||||2.36|1.07|0.02
71046559|NCT02654587|141601743|SUPERIORITY||Hazard Ratio (HR)|1.36|||<|0.05|TWO_SIDED|95.0|1.0|1.86|||t-test, 2 sided|||||1.86|1.00|<0.05
71046560|NCT01843348|141601748|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) with tx, center, donor type factors. Raw and adjusted means were presented with one-sided p-values for un-shifted and shifted hypothesis, respectively. Significance level = 2.5% (one-sided)|Least square mean|-9.35|||<|0.0001|TWO_SIDED|95.0|-13.82|-4.88|||ANOVA|||The trial tests the null hypotheses that the treatment difference (investigational minus reference) in mean eGFR at re-assigned visit Month 12 is lower than the non-inferiority margin (Δ) of 7 mL/min per 1.73m2 versus the alternative that the treatment difference is equal to or greater than the non-inferiority margin||-4.88|-13.82|<0.0001
71046561|NCT01843348|141601748|NON_INFERIORITY_OR_EQUIVALENCE|The trial tests the null hypotheses that the treatment difference (investigational minus reference) in mean eGFR at re-assigned visit Month 12 is lower than the non-inferiority margin (Δ) of 7 mL/min per 1.73m2 versus the alternative that the treatment difference is equal to or greater than the non-inferiority margin|Least squares mean|-5.56||||0.0067|TWO_SIDED|95.0|-9.56|-1.55||Analysis of variance (ANOVA) with tx, center, donor type factors. Raw and adjusted means were presented with one-sided p-values for un-shifted and shifted hypothesis, respectively. Significance level = 2.5% (one-sided)|ANOVA|||||-1.55|-9.56|0.0067
71046562|NCT01843348|141601749|SUPERIORITY_OR_OTHER||Point estimate|0.032|||||TWO_SIDED|95.0|-0.029|0.093||||||TAC+Certican - TAC+MPA - difference between groups||0.093|-0.029|
70941346|NCT03247985|141383260|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||Comparison between groups for bilateral operative time.||||0.17
71046563|NCT01843348|141601749|SUPERIORITY_OR_OTHER||Point estimate|0.149|||||TWO_SIDED|95.0|0.076|0.221||||||CycA+Certican -Tac+MPA - difference between groups||0.221|0.076|
71046564|NCT01843348|141601753|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.028|||<|0.001|TWO_SIDED|95.0|-0.032|0.087|||Pearson's chi-square test|||BPAR - treatment differences at Month 12||0.087|-0.032|< 0.001
71046565|NCT00430950|141601763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.2648||95.0|-1.51|0.42|||ANCOVA|||"The ANCOVA model included treatment as main effect and baseline mean trough sitting dBP as covariate.~Significance level alpha = 5%. Power = 80%.~The following statistical superiority hypothesis was tested:~Superiority of OM/HCTZ combination therapy 40/25 mg over OM/HCTZ 20/25 mg"||0.42|-1.51|0.2648
71046566|NCT00430950|141601764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.4246||95.0|-1.26|0.53|||ANCOVA|||||0.53|-1.26|0.4246
71046567|NCT00430950|141601765|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.7019||95.0|-1.84|1.24|||ANCOVA||refers to 8 week change; from week 8 to week 16|||1.24|-1.84|0.7019
71046568|NCT00430950|141601765|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.7328||95.0|-1.71|1.21|||ANCOVA||refers to 4 week change; from week 8 to week 12|||1.21|-1.71|0.7328
71046569|NCT00430950|141601766|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.0016||95.0|-2.58|-0.6|||ANCOVA||24 hour Ambulatory Blood Pressure Monitoring (ABPM) diastolic blood pressure (dBP)|||-0.60|-2.58|0.0016
71046570|NCT00430950|141601766|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.0031||95.0|-2.61|-0.53|||ANCOVA||daytime Ambulatory Blood Pressure Monitoring (ABPM) diastolic blood pressure (dBP)|||-0.53|-2.61|0.0031
71046571|NCT00430950|141601766|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.0073||95.0|-2.58|-0.4|||ANCOVA||night-time Ambulatory Blood Pressure Monitoring (ABPM) diastolic blood pressure (dBP)|||-0.40|-2.58|0.0073
71046572|NCT00430950|141601766|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3||||0.0021||95.0|-3.71|-0.82|||ANCOVA||24 hour Ambulatory Blood Pressure Monitoring (ABPM) systolic blood pressure (sBP)|||-0.82|-3.71|0.0021
71046573|NCT00430950|141601766|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3||||0.0031||95.0|-3.76|-0.76|||ANCOVA||daytime Ambulatory Blood Pressure Monitoring (ABPM) systolic blood pressure (sBP)|||-0.76|-3.76|0.0031
71046574|NCT00430950|141601766|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.0104||95.0|-3.61|-0.48|||ANCOVA||night-time Ambulatory Blood Pressure Monitoring (ABPM) systolic blood pressure (sBP)|||-0.48|-3.61|0.0104
71046575|NCT00430950|141601767|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||||95.0|0.85|1.4|||Regression, Logistic|||||1.40|0.85|
71046576|NCT00703508|141601787|SUPERIORITY_OR_OTHER|||||||0.0234||||||Ovulation rate vs Testosterone post-treatment, threshold for statistical significance = p\<0.05|Regression, Linear|||||||0.0234
71046577|NCT00703508|141601787|SUPERIORITY_OR_OTHER|||||||0.074||||||Ovulation rate vs Testosterone post-treatment, threshold for statistical significance = p\<0.05|Regression, Linear|||||||0.0740
71046578|NCT00703508|141601787|SUPERIORITY_OR_OTHER|||||||0.4698||||||Ovulation rate vs Testosterone post-treatment, threshold for statistical significance = p\<0.05|Regression, Linear|||||||0.4698
71046579|NCT00703508|141601787|SUPERIORITY_OR_OTHER|||||||0.118||||||Ovulation rate vs Matsuda Index post-treatment, threshold for statistical significance = p \< 0.05.|Regression, Linear|||||||0.1180
71046580|NCT00703508|141601787|SUPERIORITY_OR_OTHER|||||||0.0311||||||Ovulation rate vs Matsuda Index post-treatment, threshold for statistical significance = p \< 0.05.|Regression, Linear|||||||0.0311
71046581|NCT00703508|141601787|SUPERIORITY_OR_OTHER|||||||0.1586||||||Ovulation rate vs Matsuda Index post-treatment, threshold for statistical significance = p \< 0.05.|Regression, Linear|||||||0.1586
71046582|NCT01064323|141601800|OTHER|Paired T-test to detect if there was a change from baseline to 5 minutes into intermittent pneumatic compression (IPC)||||||0.02|||||||Paired t-test|||||||0.02
70928586|NCT04800211|141353077|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-176.627|||<|0.0001|TWO_SIDED|95.0|-222.672|-130.582|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-130.582|-222.672|<.0001
71046583|NCT01064323|141601807|OTHER|||||||0.2|||||||t-test, 2 sided|||||||0.2
71046584|NCT01564459|141601825|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.587||||0.269|TWO_SIDED|95.0|-1.637|0.464|||Constrained longitudinal data analysis|terms for treatment, time and treatment-by-time interaction||||0.464|-1.637|0.269
71046585|NCT01564459|141601826|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.687||||0.108|TWO_SIDED|95.0|-1.527|0.154|||Constrained longitudinal data analysis|terms for treatment, time and treatment-by-time interaction||||0.154|-1.527|0.108
71046586|NCT03545191|141601867|OTHER||LS mean difference to placebo|-12.2|||<|0.0001|TWO_SIDED|95.0|-17.435|-6.961||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in WASO (min) to Month 1 (Daridorexant 25 mg vs placebo).||-6.961|-17.435|<0.0001
71046587|NCT03545191|141601867|OTHER||LS mean difference to placebo|-22.78|||<|0.0001|TWO_SIDED|95.0|-27.996|-17.567||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in WASO (min) to Month 1 (Daridorexant 50 mg vs placebo).||-17.567|-27.996|<0.0001
71046588|NCT03545191|141601868|OTHER||LS mean difference to placebo|-11.86|||<|0.0001|TWO_SIDED|95.0|-17.494|-6.23||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in WASO (min) to Month 3 (Daridorexant 25 mg vs placebo).||-6.23|-17.494|<0.0001
70928587|NCT04800211|141353077|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-171.515|||<|0.0001|TWO_SIDED|95.0|-216.626|-126.404|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-126.404|-216.626|<.0001
70941347|NCT03247985|141383260|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||Comparison between groups for unilateral operative time.||||0.09
70941348|NCT03247985|141383263|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||A p-value of 0.05 was considered statistically significant.||||0.02
71046589|NCT03545191|141601868|OTHER||LS mean difference to placebo|-18.3|||<|0.0001|TWO_SIDED|95.0|-23.945|-12.661||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in WASO (min) to Month 3 (Daridorexant 50 mg vs placebo).||-12.661|-23.945|<0.0001
71046590|NCT03545191|141601869|OTHER||LS mean difference to placebo|-8.32||||0.0005|TWO_SIDED|95.0|-13.014|-3.629||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in LPS (min) to Month 1 (Daridorexant 25 mg vs placebo).||-3.629|-13.014|0.0005
71046591|NCT03545191|141601869|OTHER||LS mean difference to placebo|-11.35|||<|0.0001|TWO_SIDED|95.0|-16.022|-6.687||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in LPS (min) to Month 1 (Daridorexant 50 mg vs placebo).||-6.687|-16.022|<0.0001
71046592|NCT03545191|141601870|OTHER||LS mean difference to placebo|-7.59||||0.0015|TWO_SIDED|95.0|-12.265|-2.923||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in LPS (min) to Month 3 (Daridorexant 25 mg vs placebo).||-2.923|-12.265|0.0015
71046593|NCT03545191|141601870|OTHER||LS mean difference to placebo|-11.67|||<|0.0001|TWO_SIDED|95.0|-16.348|-6.994||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in LPS (min) to Month 3 (Daridorexant 50 mg vs placebo).||-6.994|-16.348|<0.0001
71046594|NCT03545191|141601871|OTHER||LS mean difference to placebo|12.62|||=|0.0013|TWO_SIDED|95.0|4.953|20.288||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in sTST (min) to Month 1 (Daridorexant 25 mg vs placebo).||20.288|4.953|= 0.0013
71103668|NCT02507934|141714875|SUPERIORITY|||||||0.3165|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Left - Day 21±1||||0.3165
71103669|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Right - Day 21±1||||1.0000
71046595|NCT03545191|141601871|OTHER||LS mean difference to placebo|22.06|||<|0.0001|TWO_SIDED|95.0|14.405|29.708||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in sTST (min) to Month 1 (Daridorexant 25 mg vs placebo).||29.708|14.405|< 0.0001
71046596|NCT03545191|141601872|OTHER||LS mean difference to placebo|9.93|||=|0.0334|TWO_SIDED|95.0|0.782|19.082||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in sTST (min) to Month 3 (Daridorexant 25 mg vs placebo).||19.082|0.782|= 0.0334
71046597|NCT03545191|141601872|OTHER||LS mean difference to placebo|19.77|||<|1e-05|TWO_SIDED|95.0|10.623|28.918||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in sTST (min) to Month 3 (Daridorexant 50 mg vs placebo).||28.918|10.623|< .00001
71046598|NCT03545191|141601873|OTHER||LS mean difference to placebo|-0.75|||=|0.0547|TWO_SIDED|95.0|-1.515|0.015||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 1 (Daridorexant 25 mg vs placebo).||0.015|-1.515|= 0.0547
71046599|NCT03545191|141601873|OTHER||LS mean difference to placebo|-1.75|||<|1e-05|TWO_SIDED|95.0|-2.508|-0.983||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 1 (Daridorexant 50 mg vs placebo).||-0.983|-2.508|< .00001
71046600|NCT03545191|141601874|OTHER||LS mean difference to placebo|-0.99||||0.0534|TWO_SIDED|95.0|-1.99|0.014||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 3 (Daridorexant 25 mg vs placebo).||0.014|-1.990|0.0534
71046601|NCT03545191|141601874|OTHER||LS mean difference to placebo|-1.9|||=|0.0002|TWO_SIDED|95.0|-2.905|-0.905|||Mixed Models Analysis|||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 3 (Daridorexant 50 mg vs placebo).||-0.905|-2.905|= 0.0002
71046602|NCT03545191|141601875|OTHER||LSGM ratio to placebo|0.79||||0.0003|TWO_SIDED|95.0|0.7|0.9||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 1 (Daridorexant 25 mg vs placebo).||0.90|0.70|0.0003
71046603|NCT03545191|141601875|OTHER||LSGM ratio to placebo|0.73|||<|0.0001|TWO_SIDED|95.0|0.65|0.82||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 1 (Daridorexant 50 mg vs placebo).||0.82|0.65|<0.0001
71046604|NCT03545191|141601876|OTHER||LSGM ratio to placebo|0.78||||0.0002|TWO_SIDED|95.0|0.68|0.89||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 3 (Daridorexant 25 mg vs placebo).||0.89|0.68|0.0002
71046605|NCT03545191|141601876|OTHER||LSGM ratio to placebo|0.73|||<|0.0001|TWO_SIDED|95.0|0.64|0.83||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 3 (Daridorexant 50 mg vs placebo).||0.83|0.64|<0.0001
71046606|NCT01769274|141601890|OTHER|||||||1|||||||Hierarchical rank test|||||||1.0000
71046607|NCT01769274|141601890|OTHER|||||||1|||||||Hierarchical rank test|||||||1.0000
71046608|NCT02377063|141601900|OTHER||Mean Difference (Final Values)|-11.2||||0.014|TWO_SIDED|||||p\<0.05 was defined as significant|ANOVA|||Comparison was made to day 4 minus day 0 (baseline) change of phylum Firmicutes after juice consumption||||0.014
71046609|NCT02377063|141601900|OTHER||Mean Difference (Final Values)|10.5||||0.026|TWO_SIDED|||||p\<0.05 was defined as significant|ANOVA|||Comparison was made to day 4 minus day 0 (baseline) change of phylum Bacteroidetes after juice consumption||||0.026
71046610|NCT02340221|141601921|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0037|TWO_SIDED|95.0|0.56|0.89|||Log Rank|||||0.89|0.56|0.0037
71046611|NCT02340221|141601922|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0008|TWO_SIDED|95.0|0.58|0.87|||Log Rank|||||0.87|0.58|0.0008
71046612|NCT02340221|141601923|SUPERIORITY||Odds Ratio (OR)|3.0||||0.0002|TWO_SIDED|95.0|1.6|5.4|||Cochran-Mantel-Haenszel|||||5.4|1.6|0.0002
71046613|NCT02340221|141601924|SUPERIORITY||Odds Ratio (OR)|3.1|||<|0.0001|TWO_SIDED|95.0|1.7|5.4|||Cochran-Mantel-Haenszel|||||5.4|1.7|<0.0001
71046614|NCT02340221|141601925|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.4151|TWO_SIDED|95.0|0.58|1.25|||Log Rank|||||1.25|0.58|0.4151
71046615|NCT02340221|141601926|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9974|TWO_SIDED|95.0|0.75|1.33|||Log Rank|||||1.33|0.75|0.9974
71046616|NCT02340221|141601927|SUPERIORITY||Odds Ratio (OR)|1.9|||||TWO_SIDED|95.0|1.2|2.9||||||||2.9|1.2|
71046617|NCT02340221|141601928|SUPERIORITY||Odds Ratio (OR)|1.9|||||TWO_SIDED|95.0|1.2|3.0||||||||3.0|1.2|
71046618|NCT02340221|141601929|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.6708|TWO_SIDED|95.0|0.23|2.59|||Log Rank|||||2.59|0.23|0.6708
71046619|NCT02340221|141601930|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.8286|TWO_SIDED|95.0|0.51|2.35|||Log Rank|||||2.35|0.51|0.8286
71046620|NCT02340221|141601931|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0023|TWO_SIDED|95.0|0.51|0.86|||Log Rank|||||0.86|0.51|0.0023
71046621|NCT02340221|141601932|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0095|TWO_SIDED|95.0|0.56|0.92|||Log Rank|||||0.92|0.56|0.0095
70928588|NCT04800211|141353077|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-153.812|||<|0.0001|TWO_SIDED|95.0|-199.27|-108.354|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-108.354|-199.270|<.0001
70928589|NCT04800211|141353077|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-165.22|||<|0.0001|TWO_SIDED|95.0|-195.898|-134.541|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-134.541|-195.898|<.0001
70928590|NCT04800211|141353077|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-22.815||||0.2188|TWO_SIDED|95.0|-59.223|13.593|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||13.593|-59.223|0.2188
70941349|NCT00417989|141383265|NON_INFERIORITY_OR_EQUIVALENCE|Superiority test with margin of 0.35|Mean Difference (Final Values)|0.35|STANDARD_DEVIATION|1.2||0.05|TWO_SIDED|95.0|0.24|0.46||Confidence Interval 95%|ANCOVA|ANVOCA is adjusted by study group, gender, pooled site, continuous age, duration of diabetes, BMI, and Baseline glycated hemoglobin level (A1C)||Null - There is no treatment group difference in A1c change from baseline to Week 52. Calculated that the enrollment of 495 patients would provide a power of 90% to detect an absolute difference of 0.35 percentage points in the primary outcome, assuming a SD of 1.2%.||0.46|0.24|0.05
71046622|NCT00103402|141601949|SUPERIORITY|The primary analysis compared rates for the primary outcome between study groups, using the exact conditional test version of the Mantel-Haenszel test to control for clustering by clinical center.|Risk Difference (RD)|0.1||||0.99|TWO_SIDED|95.0|-11.2|11.0|||Mantel Haenszel|The exact conditional test version of the Mantel-Haenszel test was used to control for clustering by clinical center.||Sample-size calculations were based on a 2-sided alpha of 0.05 with 80% power to detect a difference of 20 between response rates (40% placebo and 60% alfuzosin) for the Fisher's exact test. We calculated that a total sample of 270 participants would be required (135 per study group). This proposed sample size included a 20% increase to adjust for clustering within clinical sites and a 5% increase for interim monitoring.||11.0|-11.2|0.99
71046623|NCT00103402|141601950|SUPERIORITY|The primary analysis compared rates for the primary outcome between study groups, using the exact conditional test version of the Mantel-Haenszel test to control for clustering by clinical center.|Risk Difference (RD)|1.8||||0.9|TWO_SIDED|95.0|-9.0|2.5|||Mantel Haenszel|||Marked or moderate improvement at 12 weeks Absolute Difference in Rates % (95% CI)||2.5|-9.0|0.90
71046624|NCT00103402|141601951|SUPERIORITY||Mean Difference (Net)|-0.5||||0.7|TWO_SIDED|95.0|-2.7|1.5|||t-test, 2 sided|||Total score (0-43) change from baseline||1.5|-2.7|0.70
71046625|NCT00103402|141601951|SUPERIORITY||Mean Difference (Net)|-0.3||||0.64|TWO_SIDED|95.0|-1.4|0.8|||t-test, 2 sided|||Pain score (0-21) change from baseline||0.8|-1.4|0.64
71046626|NCT00103402|141601951|SUPERIORITY||Mean Difference (Net)|-0.2||||0.62|TWO_SIDED|95.0|-0.8|0.4|||t-test, 2 sided|||Urinary score (0-10) change from baseline||0.4|-0.8|0.62
71046627|NCT00103402|141601951|SUPERIORITY||Mean Difference (Net)|0.0||||0.99|TWO_SIDED|95.0|-0.4|0.4|||t-test, 2 sided|||Quality of life score (0-12) change from baseline||0.4|-0.4|.99
71046628|NCT00103402|141601952|SUPERIORITY||Mean Difference (Net)|-0.3||||0.45|TWO_SIDED|95.0|-1.8|1.2|||t-test, 2 sided|||McGill Total Score||1.2|-1.8|0.45
71046629|NCT00103402|141601952|SUPERIORITY||Mean Difference (Net)|-0.2||||0.47|TWO_SIDED|95.0|-1.4|1.0|||t-test, 2 sided|||McGill Sensory Score||1.0|-1.4|0.47
71046630|NCT00103402|141601952|SUPERIORITY||Mean Difference (Net)|-0.1||||0.89|TWO_SIDED|95.0|-0.6|0.4|||t-test, 2 sided|||McGill Affective Score||0.4|-0.6|0.89
71046631|NCT00103402|141601953|SUPERIORITY||Mean Difference (Net)|-0.5||||0.6|TWO_SIDED|95.0|-2.3|1.3|||t-test, 2 sided|||Physical component summary (0-100) change in scores||1.3|-2.3|0.60
71103670|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Left - Day 21±1||||1.0000
71046632|NCT00103402|141601953|SUPERIORITY||Mean Difference (Net)|2.1||||0.16|TWO_SIDED|95.0|-0.4|4.6|||t-test, 2 sided|||Mental component summary (0-100) Absolute Difference between Groups (95% CI)||4.6|-0.4|0.16
71103671|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Right - Day 21±1||||1.0000
71103672|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Left - Day 21±1||||1.0000
71103673|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Right - Day 21±1||||1.0000
71046633|NCT00103402|141601954|SUPERIORITY||Mean Difference (Net)|-1.1||||0.08|TWO_SIDED|95.0|-2.4|0.2|||t-test, 2 sided|||||0.2|-2.4|0.08
70928591|NCT04800211|141353078|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-248.311|||<|0.0001|TWO_SIDED|95.0|-286.423|-210.199|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-210.199|-286.423|<.0001
70928592|NCT04800211|141353078|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-247.572|||<|0.0001|TWO_SIDED|95.0|-280.904|-214.241|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-214.241|-280.904|<.0001
70928593|NCT04800211|141353078|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-245.868|||<|0.0001|TWO_SIDED|95.0|-284.945|-206.791|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-206.791|-284.945|<.0001
71046634|NCT00103402|141601955|SUPERIORITY||Risk Difference (RD)|0.7||||0.94|TWO_SIDED|95.0|-2.6|4.0|||t-test, 2 sided|||||4.0|-2.6|0.94
70928594|NCT04800211|141353078|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-234.942|||<|0.0001|TWO_SIDED|95.0|-271.603|-198.282|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-198.282|-271.603|<.0001
71046635|NCT00103402|141601956|SUPERIORITY||Mean Difference (Net)|1.1||||0.06|TWO_SIDED|95.0|-0.3|2.5|||t-test, 2 sided|||||2.5|-0.3|0.06
71046636|NCT03182582|141601966|SUPERIORITY|||||||0.003|||||||Paired t test|||A sample size of 22 patients was required to achieve 80% power, using a two-tailed test with α = 0.05.||||0.003
71046637|NCT01172821|141601974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.211|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.159|0.264|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.264|0.159|<0.0001
71046638|NCT01172821|141601974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.116|0.222|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.222|0.116|<0.0001
71103674|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Left - Day 21±1||||1.0000
71103675|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Right - Day 21±1||||1.0000
71103676|NCT02507934|141714875|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Left - Day 21±1||||1.0000
71103677|NCT02507934|141714876|SUPERIORITY||Mean Difference (Final Values)|1.12||||0.0599|TWO_SIDED|95.0|-0.05|2.29|||Student t-test for unpaired data|||T-test on changes from baseline in Intraocular pressure - Left eye - Day 7±1||2.29|-0.05|0.0599
71046639|NCT01172821|141601975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001|TWO_SIDED|95.0|0.12|0.233|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.233|0.120|<0.0001
71046640|NCT01172821|141601975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001|TWO_SIDED|95.0|0.076|0.19|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.190|0.076|<0.0001
71046641|NCT01172821|141601976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.03||0.0002|TWO_SIDED|95.0|0.052|0.168|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.168|0.052|0.0002
71046642|NCT01172821|141601976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.03||0.0031|TWO_SIDED|95.0|0.03|0.147|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.147|0.030|0.0031
71046643|NCT01172821|141601977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.032||0.0061|TWO_SIDED|95.0|0.025|0.149|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.149|0.025|0.0061
70928595|NCT04800211|141353078|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-244.049|||<|0.0001|TWO_SIDED|95.0|-275.269|-212.829|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-212.829|-275.269|<.0001
70928596|NCT04800211|141353078|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-221.385|||<|0.0001|TWO_SIDED|95.0|-258.371|-184.398|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-184.398|-258.371|<.0001
70928597|NCT04800211|141353078|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-233.626|||<|0.0001|TWO_SIDED|95.0|-261.113|-206.14|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-206.140|-261.113|<.0001
70941350|NCT00417989|141383267|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|STANDARD_DEVIATION|2.0||0.84|TWO_SIDED|95.0|0.64|2.41|||Mantel Haenszel|||||2.41|0.64|0.84
70941351|NCT00417989|141383268|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation based on this endpoint. Results will be calculated on testing for statistical difference between arms.||||||0.05||95.0|||||ANCOVA|ANVOCA is adjusted by study group, gender, pooled site, continuous age, duration of diabetes, BMI, and Baseline AUC||||||0.05
70941352|NCT00417989|141383269|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation based on this endpoint. Results will be calculated on testing for statistical difference between arms.||||||0.05||95.0|||||ANCOVA|ANVOCA is adjusted by study group, gender, pooled site, continuous age, duration of diabetes, BMI, and Baseline AUC||||||0.05
70941353|NCT00417989|141383270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5|STANDARD_DEVIATION|16.0|<|0.001||95.0|-9.76|-3.273|||ANCOVA|||||-3.273|-9.760|< 0.001
70928598|NCT04800211|141353078|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|26.266||||0.1672|TWO_SIDED|95.0|-11.13|63.661|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||63.661|-11.130|0.1672
70928599|NCT04800211|141353078|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-40.051||||0.014|TWO_SIDED|95.0|-71.881|-8.221|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-8.221|-71.881|0.0140
70928600|NCT04800211|141353078|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-42.635||||0.0288|TWO_SIDED|95.0|-80.785|-4.484|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-4.484|-80.785|0.0288
71046644|NCT01172821|141601977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.083|STANDARD_ERROR_OF_MEAN|0.032||0.0093|TWO_SIDED|95.0|0.021|0.146|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.146|0.021|0.0093
71046645|NCT01172821|141601978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.201|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.15|0.252|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.252|0.150|<0.0001
71046646|NCT01172821|141601978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.163|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.112|0.215|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.215|0.112|<0.0001
71046647|NCT01172821|141601979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108|STANDARD_ERROR_OF_MEAN|0.029||0.0002|TWO_SIDED|95.0|0.052|0.164|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.164|0.052|0.0002
71046648|NCT01172821|141601979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.029||0.0019|TWO_SIDED|95.0|0.033|0.145|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.145|0.033|0.0019
71046649|NCT01172821|141601980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.759|STANDARD_ERROR_OF_MEAN|4.963|<|0.0001|TWO_SIDED|95.0|19.025|38.494|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||38.494|19.025|<0.0001
71079468|NCT00482170|141666447|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.628|TWO_SIDED|95.0|0.62|1.33||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.33|0.62|0.628
71046650|NCT01172821|141601980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.178|STANDARD_ERROR_OF_MEAN|4.985|<|0.0001|TWO_SIDED|95.0|18.401|37.956|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||37.956|18.401|<0.0001
71046651|NCT01172821|141601981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.068||0.87|TWO_SIDED|95.0|-0.122|0.144|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.144|-0.122|0.8700
70928601|NCT04800211|141353078|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-274.577|||<|0.0001|TWO_SIDED|95.0|-345.428|-203.726|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-203.726|-345.428|<.0001
70928602|NCT04800211|141353078|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-207.521|||<|0.0001|TWO_SIDED|95.0|-269.198|-145.844|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-145.844|-269.198|<.0001
70928603|NCT04800211|141353078|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-203.233|||<|0.0001|TWO_SIDED|95.0|-275.683|-130.784|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-130.784|-275.683|<.0001
70928604|NCT04800211|141353078|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-261.208|||<|0.0001|TWO_SIDED|95.0|-330.647|-191.769|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-191.769|-330.647|<.0001
70928605|NCT04800211|141353078|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-203.998|||<|0.0001|TWO_SIDED|95.0|-263.396|-144.599|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-144.599|-263.396|<.0001
70941354|NCT00417989|141383272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|7.75|||||||||Mean difference|||||||
70941355|NCT00417989|141383273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.6|STANDARD_DEVIATION|25.53|||TWO_SIDED||||||Mean Difference|||||||
70941356|NCT01436045|141383279|SUPERIORITY_OR_OTHER||Percent Change|-15.7|STANDARD_ERROR_OF_MEAN|7.0|<|0.05|TWO_SIDED|||||RBANS Line Orientation|t-test, 2 sided||Response to intranasal Insulin Glulisine \[(result post-insulin - result post-placebo)/(result post-placebo)\] x 100%|Response to intranasal Insulin Gluiline \[(result post-insulin - result post-placebo)/(result post-placebo)\] x 100%||||<0.05
71103678|NCT02507934|141714876|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.3969|TWO_SIDED|95.0|-0.68|1.66|||Student t-test for unpaired data|||T-test on changes from baseline in Intraocular pressure - Right eye - Day 7±1||1.66|-0.68|0.3969
71103679|NCT02507934|141714876|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.7225|TWO_SIDED|95.0|-1.29|1.84|||Student t-test for unpaired data|||T-test on changes from baseline in Intraocular pressure - Left eye - Day 14±1||1.84|-1.29|0.7225
71103680|NCT02507934|141714876|SUPERIORITY||Mean Difference (Final Values)|-0.76||||0.269|TWO_SIDED|95.0|-2.14|0.62|||Student t-test for unpaired data|||T-test on changes from baseline in Intraocular pressure - Right eye - Day 14±1||0.62|-2.14|0.2690
71103681|NCT02507934|141714876|SUPERIORITY||Mean Difference (Final Values)|0.78||||0.2344|TWO_SIDED|95.0|-0.53|2.1|||Student t-test for unpaired data|||T-test on changes from baseline in Intraocular pressure - Left eye - Day 21±1||2.10|-0.53|0.2344
71103682|NCT02507934|141714876|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.5953|TWO_SIDED|95.0|-1.3|2.24|||Student t-test for unpaired data|||T-test on changes from baseline in Intraocular pressure - Right eye||2.24|-1.30|0.5953
71103683|NCT02507934|141714877|SUPERIORITY||Mean Difference (Final Values)|0.79||||0.2193|TWO_SIDED|95.0|-0.54|2.11|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 7||2.11|-0.54|0.2193
71103684|NCT02507934|141714877|SUPERIORITY||Mean Difference (Final Values)|1.34||||0.0024|TWO_SIDED|95.0|0.51|2.18|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 8||2.18|0.51|0.0024
71103685|NCT02507934|141714877|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.425|TWO_SIDED|95.0|-0.49|1.14|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 9||1.14|-0.49|0.4250
71103686|NCT02507934|141714877|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.1275|TWO_SIDED|95.0|-0.17|1.29|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 10||1.29|-0.17|0.1275
71103687|NCT02507934|141714877|SUPERIORITY||Mean Difference (Final Values)|0.66||||0.0844|TWO_SIDED|95.0|-0.09|1.42|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 11||1.42|-0.09|0.0844
71103688|NCT02507934|141714877|SUPERIORITY||Mean Difference (Final Values)|0.86||||0.0238|TWO_SIDED|95.0|0.12|1.6|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 12||1.60|0.12|0.0238
71103689|NCT02507934|141714877|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.0369|TWO_SIDED|95.0|0.05|1.61|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 13||1.61|0.05|0.0369
71103690|NCT02507934|141714877|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.3496|TWO_SIDED|95.0|-0.61|1.64|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 14||1.64|-0.61|0.3496
71103691|NCT02947048|141714904|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.42||0.61|TWO_SIDED||||||ANCOVA|||Clinical Global Impression - Severity||||0.61
71103692|NCT02947048|141714904|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.52||0.33|TWO_SIDED||||||ANCOVA|||Clinical Global Impression - Severity||||0.33
71103693|NCT02947048|141714904|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.47||0.61|TWO_SIDED||||||ANCOVA|||Clinical Global Impression - Improvement||||0.61
71103694|NCT02947048|141714904|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.43||0.91|TWO_SIDED||||||ANCOVA|||Clinical Global Impression - Improvement||||0.91
71103695|NCT03895372|141714937|SUPERIORITY||Risk Difference (RD)|8.87||||0.2621|TWO_SIDED|90.0|-4.5|26.26||One-sided Hochberg p-value, significant level is 0.05.|Chan and Zhang method|||The analysis was based on the data at Week 16.||26.26|-4.50|0.2621
71103696|NCT03895372|141714937|SUPERIORITY||Risk Difference (RD)|4.76||||0.2621|TWO_SIDED|90.0|-7.07|21.48||One-sided Hochberg p-value, significant level is 0.05.|Chan and Zhang method|||The analysis was based on the data at Week 16.||21.48|-7.07|0.2621
70941357|NCT01436045|141383282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92|STANDARD_ERROR_OF_MEAN|0.26|<|0.05|TWO_SIDED||||||t-test, 2 sided|||Difference in errors \[result post-insulin - result post-placebo\]||||<0.05
71103697|NCT03895372|141714937|SUPERIORITY||Risk Difference (RD)|33.02||||0.0004|TWO_SIDED|90.0|18.01|47.11||One-sided Hochberg p-value, significant level is 0.05.|Chan and Zhang method|||The analysis was based on the data at Week 16.||47.11|18.01|0.0004
71103698|NCT03895372|141714937|SUPERIORITY||Risk Difference (RD)|46.46|||<|0.0001|TWO_SIDED|90.0|30.62|60.56||One-sided Hochberg p-value, significant level is 0.05.|Chan and Zhang method|||The analysis was based on the data at Week 16.||60.56|30.62|<0.0001
71103699|NCT03895372|141714945|SUPERIORITY||Risk Difference (RD)|3.9|||||TWO_SIDED|90.0|-11.82|23.42||||||The analysis was based on the data at Week 16.||23.42|-11.82|
71103700|NCT03895372|141714945|SUPERIORITY||Risk Difference (RD)|-4.76|||||TWO_SIDED|90.0|-18.61|13.29||||||The analysis was based on the data at Week 16.||13.29|-18.61|
71103701|NCT03895372|141714945|SUPERIORITY||Risk Difference (RD)|32.38|||||TWO_SIDED|90.0|14.32|47.52||||||The analysis was based on the data at Week 16.||47.52|14.32|
71103702|NCT03895372|141714945|SUPERIORITY||Risk Difference (RD)|58.89|||||TWO_SIDED|90.0|41.01|72.41||||||The analysis was based on the data at Week 16.||72.41|41.01|
71103703|NCT03895372|141714946|SUPERIORITY||Risk Difference (RD)|1.52|||||TWO_SIDED|90.0|-14.52|20.77||||||The analysis was based on the data at Week 16.||20.77|-14.52|
71103704|NCT03895372|141714946|SUPERIORITY||Risk Difference (RD)|-2.38|||||TWO_SIDED|90.0|-17.67|17.01||||||The analysis was based on the data at Week 16.||17.01|-17.67|
71103705|NCT03895372|141714946|SUPERIORITY||Risk Difference (RD)|27.78|||||TWO_SIDED|90.0|8.86|43.26||||||The analysis was based on the data at Week 16.||43.26|8.86|
71103706|NCT03895372|141714946|SUPERIORITY||Risk Difference (RD)|54.07|||||TWO_SIDED|90.0|36.46|68.27||||||The analysis was based on the data at Week 16.||68.27|36.46|
70941358|NCT02799745|141383288|SUPERIORITY||Hazard Ratio (HR)|0.542||||0.016|TWO_SIDED|95.0|0.33|0.892||P-value was from a 2-sided stratified log-rank test.|Log Rank||HR, 95% CI for HR:based on a Cox regression model assuming proportional hazards with treatment, prostate cancer risk,type of biopsy,baseline variables(as age, race), time since prostate cancer diagnosis as fixed effects and random effect of site.|||0.892|0.330|0.016
71010486|NCT03451630|141527931|SUPERIORITY|||||||0.4732||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.88 with degrees of freedom (4, 1945).||Overall test for the treatment-by-time interaction||||0.4732
70941359|NCT02799745|141383290|SUPERIORITY||Odds Ratio (OR)|3.5||||0|TWO_SIDED|95.0|1.76|6.92||P-value: Based on the exact binomial distribution from the logistic regression model.|Regression, Logistic||OR: from logistic regression model where fixed covariates=treatment group, prostate cancer risk, type of biopsy, age, race and time since prostate cancer diagnosis; random effects: site and subject. 95% CI: based on exact binomial distribution.|At the end of month 12||6.92|1.76|0.00
71010487|NCT03451630|141527931|SUPERIORITY||||||<|0.0001||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 319.14 with degrees of freedom (2, 1948).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||<0.0001
71010488|NCT03451630|141527931|SUPERIORITY|||||||0.9628||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.04 with degrees of freedom (2, 1948).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.9628
71010489|NCT03451630|141527931|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.07||0.8438|TWO_SIDED|95.0|-0.16|0.19||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.04 with degrees of freedom (1, 1945).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.19|-0.16|0.8438
71010490|NCT03451630|141527931|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.7425|TWO_SIDED|95.0|-0.19|0.15||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.11 with degrees of freedom (1, 1945).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.15|-0.19|0.7425
71010491|NCT03451630|141527931|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.5044|TWO_SIDED|95.0|-0.1|0.17||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.45 with degrees of freedom (1, 1945).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.17|-0.10|0.5044
71010492|NCT03451630|141527932|SUPERIORITY|||||||0.9804||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.11 with degrees of freedom (4, 3164).||Overall test for the treatment-by-time interaction||||0.9804
71010493|NCT03451630|141527932|SUPERIORITY||||||<|0.0001||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 21.80 with degrees of freedom (2, 3168).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||<0.0001
71010494|NCT03451630|141527932|SUPERIORITY|||||||0.9764||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.02 with degrees of freedom (2, 1211).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.9764
71046652|NCT01172821|141601981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.068||0.9612|TWO_SIDED|95.0|-0.137|0.13|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.130|-0.137|0.9612
71103707|NCT03895372|141714947|SUPERIORITY||Risk Difference (RD)|1.52|||||TWO_SIDED|90.0|-14.52|20.77||||||The analysis was based on the data at Week 16.||20.77|-14.52|
71103708|NCT03895372|141714947|SUPERIORITY||Risk Difference (RD)|-2.38|||||TWO_SIDED|90.0|-17.67|17.01||||||The analysis was based on the data at Week 16.||17.01|-17.67|
71103709|NCT03895372|141714947|SUPERIORITY||Risk Difference (RD)|27.78|||||TWO_SIDED|90.0|8.86|43.26||||||The analysis was based on the data at Week 16.||43.26|8.86|
71103710|NCT03895372|141714947|SUPERIORITY||Risk Difference (RD)|54.07|||||TWO_SIDED|90.0|36.46|68.27||||||The analysis was based on the data at Week 16.||68.27|36.46|
71103711|NCT03895372|141714950|SUPERIORITY||Least Squares Mean Difference|-1.46|||||TWO_SIDED|90.0|-5.42|2.51||||||The analysis was based on the data at Week 16.||2.51|-5.42|
71103712|NCT03895372|141714950|SUPERIORITY||Least Squares Mean Difference|-3.54|||||TWO_SIDED|90.0|-7.5|0.42||||||The analysis was based on the data at Week 16.||0.42|-7.50|
71103713|NCT03895372|141714950|SUPERIORITY||Least Squares Mean Difference|-9.8|||||TWO_SIDED|90.0|-13.05|-6.56||||||The analysis was based on the data at Week 16.||-6.56|-13.05|
71103714|NCT03895372|141714950|SUPERIORITY||Least Squares Mean Difference|-12.33|||||TWO_SIDED|90.0|-15.61|-9.04||||||The analysis was based on the data at Week 16.||-9.04|-15.61|
71010495|NCT03451630|141527932|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9757|TWO_SIDED|95.0|0.63|1.6||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|T-test statistics 0.03.||Odds ratio of Treatment at 12-Months||1.60|0.63|0.9757
71010496|NCT03451630|141527932|SUPERIORITY||Odds Ratio (OR)|1.06||||0.7958|TWO_SIDED|95.0|0.67|1.68||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|T-test statistics 0.26.||Odds ratio of Treatment at 12-Months||1.68|0.67|0.7958
71010497|NCT03451630|141527932|SUPERIORITY||Odds Ratio (OR)|0.95||||0.7646|TWO_SIDED|95.0|0.67|1.34||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|T-statistics -0.30||Odds ratio of Treatment at 12-Months||1.34|0.67|0.7646
71010498|NCT03451630|141527933|SUPERIORITY|||||||0.9622||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.15 with degrees of freedom (4, 3164).||Overall test for the treatment-by-time interaction||||0.9622
71010499|NCT03451630|141527933|SUPERIORITY|||||||0.0377||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 3.28 with degrees of freedom (2, 3168).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||0.0377
71010500|NCT03451630|141527933|SUPERIORITY|||||||0.83||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistic 0.19 with degrees of freedom (2, 1903).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.8300
71046653|NCT01172821|141601982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.127|STANDARD_ERROR_OF_MEAN|0.059||0.0305|TWO_SIDED|95.0|-0.241|-0.012|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||-0.012|-0.241|0.0305
71046654|NCT01172821|141601982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.083|STANDARD_ERROR_OF_MEAN|0.059||0.1602|TWO_SIDED|95.0|-0.198|0.033|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.033|-0.198|0.1602
71046655|NCT01172821|141601983|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.4012|TWO_SIDED|95.0|0.81|1.74||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R2.5 / Placebo|||1.74|0.81|0.4012
71046656|NCT01172821|141601983|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||1.1727|TWO_SIDED|95.0|0.67|1.42||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|||1.42|0.67|1.1727
71046657|NCT01172821|141601984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.613|STANDARD_ERROR_OF_MEAN|4.496|<|0.0001|TWO_SIDED|95.0|11.795|29.431|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||29.431|11.795|<0.0001
71046658|NCT01172821|141601984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.757|STANDARD_ERROR_OF_MEAN|4.513|<|0.0001|TWO_SIDED|95.0|15.907|33.607|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||33.607|15.907|<0.0001
71046659|NCT01172821|141601985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.991|STANDARD_ERROR_OF_MEAN|4.547||0.0004|TWO_SIDED|95.0|7.074|24.908|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||24.908|7.074|0.0004
71046660|NCT01172821|141601985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.247|STANDARD_ERROR_OF_MEAN|4.561|<|0.0001|TWO_SIDED|95.0|12.302|30.193|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||30.193|12.302|<0.0001
71046661|NCT01172821|141601986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.953|STANDARD_ERROR_OF_MEAN|0.598||0.1114|TWO_SIDED|95.0|-2.125|0.22|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.220|-2.125|0.1114
71103715|NCT03895372|141714951|SUPERIORITY||Least Squares Mean Difference|-8.63|||||TWO_SIDED|90.0|-23.61|6.35||||||The analysis was based on the data at Week 16.||6.35|-23.61|
71103716|NCT03895372|141714951|SUPERIORITY||Least Squares Mean Difference|-13.02|||||TWO_SIDED|90.0|-27.98|1.94||||||The analysis was based on the data at Week 16.||1.94|-27.98|
71103717|NCT03895372|141714951|SUPERIORITY||Least Squares Mean Difference|-40.74|||||TWO_SIDED|90.0|-53.02|-28.46||||||The analysis was based on the data at Week 16.||-28.46|-53.02|
71103718|NCT03895372|141714951|SUPERIORITY||Least Squares Mean Difference|-53.04|||||TWO_SIDED|90.0|-65.44|-40.63||||||The analysis was based on the data at Week 16.||-40.63|-65.44|
71103719|NCT03895372|141714952|SUPERIORITY||Least Squares Mean Difference|-1.22|||||TWO_SIDED|90.0|-2.52|0.09||||||The analysis was based on the data at Week 16.||0.09|-2.52|
71103720|NCT03895372|141714952|SUPERIORITY||Least Squares Mean Difference|-1.21|||||TWO_SIDED|90.0|-2.46|0.05||||||The analysis was based on the data at Week 16.||0.05|-2.46|
71103721|NCT03895372|141714952|SUPERIORITY||Least Squares Mean Difference|-3.47|||||TWO_SIDED|90.0|-4.51|-2.43||||||The analysis was based on the data at Week 16.||-2.43|-4.51|
71103722|NCT03895372|141714952|SUPERIORITY||Least Squares Mean Difference|-3.66|||||TWO_SIDED|90.0|-4.71|-2.61||||||The analysis was based on the data at Week 16.||-2.61|-4.71|
71103723|NCT03895372|141714953|SUPERIORITY||Risk Difference (RD)|12.99|||||TWO_SIDED|90.0|-4.52|32.87||||||The analysis was based on the data at Week 16.||32.87|-4.52|
71103724|NCT03895372|141714953|SUPERIORITY||Risk Difference (RD)|23.81|||||TWO_SIDED|90.0|2.62|44.64||||||The analysis was based on the data at Week 16.||44.64|2.62|
71103725|NCT03895372|141714953|SUPERIORITY||Risk Difference (RD)|41.27|||||TWO_SIDED|90.0|23.47|56.18||||||The analysis was based on the data at Week 16.||56.18|23.47|
71103726|NCT03895372|141714953|SUPERIORITY||Risk Difference (RD)|49.13|||||TWO_SIDED|90.0|30.62|63.69||||||The analysis was based on the data at Week 16.||63.69|30.62|
71103727|NCT03895372|141714954|SUPERIORITY||Least Squares Mean Difference|-4.21|||||TWO_SIDED|90.0|-7.82|-0.59||||||The analysis was based on the data at Week 16.||-0.59|-7.82|
71103728|NCT03895372|141714954|SUPERIORITY||Least Squares Mean Difference|-6.44|||||TWO_SIDED|90.0|-9.89|-2.99||||||The analysis was based on the data at Week 16.||-2.99|-9.89|
71103729|NCT03895372|141714954|SUPERIORITY||Least Squares Mean Difference|-10.51|||||TWO_SIDED|90.0|-13.4|-7.62||||||The analysis was based on the data at Week 16.||-7.62|-13.40|
71103730|NCT03895372|141714954|SUPERIORITY||Least Squares Mean Difference|-10.81|||||TWO_SIDED|90.0|-13.68|-7.94||||||The analysis was based on the data at Week 16.||-7.94|-13.68|
71103731|NCT03331354|141714964|SUPERIORITY||Cox Proportional Hazard|1.87|||=|0.016|TWO_SIDED||||||Chi-squared|||||||=.016
71103732|NCT03331354|141714965|SUPERIORITY|||||||0.008|||||||ANCOVA|Initial interview scores were used as control in the ANCOVA||||||.008
71103733|NCT03331354|141714966|SUPERIORITY|||||||0.99|||||||ANCOVA|Change in confidence was evaluated using time one as a covariate.||||||.99
71103734|NCT03331354|141714966|SUPERIORITY|||||||0.99|||||||ANCOVA|Interview scores at enrollment were used as a covariate||||||.99
71103735|NCT03331354|141714967|OTHER||||||<|0.001|||||||Pearson Correlation|||This post-hoc analysis was performed on only the COMPASS group to determine the association between percent of the online system completed and change in interview scores||||<.001
71103736|NCT04047355|141714974|SUPERIORITY||Median Difference (Final Values)|3.0||||0.12|TWO_SIDED|||||The a-priori threshold for statistical significance was set at α = 0.05.|Wilcoxon (Mann-Whitney)||The placebo phase serves as the control condition and the propranolol phase serves as the treatment condition.|A post-hoc power analysis was conducted using G\*Power, v. 3.1, to determine the achieved power for the Wilcoxon signed-rank test for matched pairs.||||0.12
71103737|NCT04047355|141714974|SUPERIORITY||Effect size (r)|-0.64|||||TWO_SIDED|||||||||||||
71103738|NCT04047355|141714974|SUPERIORITY||Post-hoc power analysis|0.39|||||TWO_SIDED||||||||The alpha error probability was set at α = 0.05 (two-tailed).|||||
71103739|NCT04047355|141714975|SUPERIORITY||Median Difference (Final Values)|2.0||||0.07|TWO_SIDED|||||The a-priori threshold for statistical significance was set at α = 0.05.|Wilcoxon (Mann-Whitney)||The placebo phase serves as the control condition and the propranolol phase serves as the treatment condition.|A post-hoc power analysis was conducted using G\*Power, v. 3.1, to determine the achieved power for the Wilcoxon signed-rank test for matched pairs.||||0.07
71103740|NCT04047355|141714975|SUPERIORITY||Effect size (r)|-0.74|||||TWO_SIDED|||||||||||||
71103741|NCT04047355|141714975|SUPERIORITY||Post-hoc power analysis|0.59|||||TWO_SIDED||||||||The alpha error probability was set at α = 0.05 (two-tailed).|||||
71103742|NCT05889468|141714976|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test, a non-parametric test, was used since the empirical distribution of data did not follow the normality assumption.||This was an intention-to-treat analysis.||||0.49
71103743|NCT05889468|141714977|SUPERIORITY|||||||0.32|||||||Fisher Exact|||Intention-to-treat analysis||||0.32
71103744|NCT05889468|141714979|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||Intention-to-treat analysis||||>0.99
71103745|NCT05889468|141714980|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||Intention-to-treat analysis||||>0.99
71103746|NCT05468918|141714987|OTHER|||||||0.002|||||||ANOVA|||||||0.002
71103747|NCT05468918|141714988|OTHER|||||||0.023|||||||ANOVA|||||||0.023
71103748|NCT03900650|141715003|OTHER||Mean Difference (Final Values)|7.32|||<|0.01|TWO_SIDED||||||ANOVA|||||||<.01
71103749|NCT03900650|141715004|OTHER||Mean Difference (Final Values)|0.377||||0.77|TWO_SIDED|||||This p-value tests the effect of the study arms on number of sex events.|ANOVA|||||||.770
71103750|NCT00427700|141715005|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.0||||0.3|TWO_SIDED|95.0|-9.0|33.0|||Fisher Exact|||The null hypothesis is that there is no significant difference between two drugs for ovulation induction.A sample size of 40 women per arm was calculated for this superiority trial, considering an alpha and beta error of 0.05 and 0.2, respectively, to find an absolute difference of 30% in the ovulation rate between groups, based on a previous study published by Mitwally and Casper (18) where the ovulation rate with CC was approximately 45%.||33|-9|0.3
71103751|NCT00427700|141715006|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.0||||0.2|TWO_SIDED|95.0|-6.0|34.0|||t-test, 2 sided|||Null hypothesis: There is no difference between the mean values of progesterone between both groups.||34|-6|0.2
71010501|NCT03451630|141527933|SUPERIORITY||Odds Ratio (OR)|0.87||||0.7507|TWO_SIDED|95.0|0.38|2.0||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|T-statistics -0.32||Odds ratio of Treatment at 12-Months||2.00|0.38|0.7507
71010502|NCT03451630|141527933|SUPERIORITY||Odds Ratio (OR)|0.94||||0.8844|TWO_SIDED|95.0|0.42|2.13||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|T-statistics -0.15||Odds ratio of Treatment at 12-Months||2.13|0.42|0.8844
71010503|NCT03451630|141527933|SUPERIORITY||Odds Ratio (OR)|0.93||||0.8227|TWO_SIDED|95.0|0.49|1.77||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|T-statistics -0.22||Odds ratio of Treatment at 12-Months||1.77|0.49|0.8227
71010504|NCT03451630|141527934|OTHER|||||||1|||||||Fisher Exact|Fisher's exact test for the null hypothesis of no association between each event and treatment group.||Frequency and test of the marginal association between event rate and treatment for eligible participants' data at 12 months for MMA-1a||||1.00
71010505|NCT03451630|141527934|OTHER|||||||0.242|||||||Fisher Exact|Fisher's exact test for the null hypothesis of no association between each event and treatment group.||Frequency and test of the marginal association between event rate and treatment for eligible participants' data at 12 months for MMA-1b||||0.242
71010506|NCT03451630|141527935|OTHER|||||||0.1112|||||||Fisher Exact|Fisher's exact test for the null hypothesis of no association between each event and treatment group.||Test of the marginal association between event rate and treatment for eligible participants' data at 12 months for PCE-1||||0.1112
71010507|NCT03451630|141527935|OTHER|||||||0.4754|||||||Fisher Exact|Fisher's exact test for the null hypothesis of no association between each event and treatment group.||Test of the marginal association between event rate and treatment for eligible participants' data at 12 months for PCE-2||||0.4754
71010508|NCT03451630|141527936|SUPERIORITY||Odds Ratio (OR)|0.74||||0.9079|TWO_SIDED|95.0|0.13|4.28||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.19 with degrees of freedom (2).||Test for the treatment effect (without weight) using a Firth's penalized logistic regression model for rare events.||4.28|0.13|0.9079
71010509|NCT03451630|141527936|SUPERIORITY||Odds Ratio (OR)|0.68||||0.9079|TWO_SIDED|95.0|0.13|3.72||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.19 with degrees of freedom (2).||Test for the treatment effect (without weight) using a Firth's penalized logistic regression model for rare events.||3.72|0.13|0.9079
71010510|NCT03451630|141527936|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9079|TWO_SIDED|95.0|0.34|3.45||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.19 with degrees of freedom (2).||Test for the treatment effect (without weight) using a Firth's penalized logistic regression model for rare events.||3.45|0.34|0.9079
71010511|NCT03451630|141527937|SUPERIORITY|||||||0.9912||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.07 with degrees of freedom (4, 335).||Test for the treatment-by-time interaction (without weight) for SPC-1.||||0.9912
71010512|NCT03451630|141527937|SUPERIORITY|||||||0.876||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.13 with degrees of freedom (2, 339).||Test for change over time for SPC-1||||0.8760
70941360|NCT02799745|141383290|SUPERIORITY||Odds Ratio (OR)|1.6||||0.289|TWO_SIDED|95.0|0.66|4.0||P-value: Based on the exact binomial distribution from the logistic regression model.|Regression, Logistic||OR: from logistic regression model where fixed covariates=treatment group, prostate cancer risk, type of biopsy, age, race and time since prostate cancer diagnosis; random effects: site and subject. 95% CI: based on exact binomial distribution.|At the end of month 24||4.00|0.66|0.289
71010513|NCT03451630|141527937|SUPERIORITY|||||||0.678||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.39 with degrees of freedom (2, 276).||Test for change in treatment effect for SPC-1||||0.6780
71010514|NCT03451630|141527937|SUPERIORITY|||||||0.1761||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.59 with degrees of freedom (4, 284).||Test for the treatment-by-time interaction (without weight) for SPC-2||||0.1761
71010515|NCT03451630|141527937|SUPERIORITY|||||||0.3239||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.13 with degrees of freedom (2, 288).||Test for change over time for SPC-2||||0.3239
70928606|NCT04800211|141353078|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-178.75|||<|0.0001|TWO_SIDED|95.0|-249.092|-108.408|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-108.408|-249.092|<.0001
70928607|NCT04800211|141353078|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-190.992|||<|0.0001|TWO_SIDED|95.0|-237.134|-144.85|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-144.850|-237.134|<.0001
70928608|NCT04800211|141353078|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-24.483||||0.359|TWO_SIDED|95.0|-77.096|28.13|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||28.130|-77.096|0.3590
70928609|NCT04800211|141353079|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-2.287|||<|0.0001|TWO_SIDED|95.0|-2.582|-1.992|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-1.992|-2.582|<.0001
70928610|NCT04800211|141353079|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.415|||<|0.0001|TWO_SIDED|95.0|-2.722|-2.107|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-2.107|-2.722|<.0001
71010516|NCT03451630|141527937|SUPERIORITY|||||||0.7415||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.30 with degrees of freedom (2, 139).||Test for change in treatment effect for SPC-2||||0.7415
71010517|NCT03451630|141527938|SUPERIORITY|||||||0.9786||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.11 with degrees of freedom (4, 608).||Test for the treatment-by-time interaction (without weight) for SPD-1.||||0.9786
71103752|NCT00721110|141715018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93||||0.96|TWO_SIDED|97.5|-52.0|54.0||Significant if P \< 0.003 for efficacy and P \> 0.5311 for futility; 97.5% confidence intervals adjusted for group sequential design to maintain the overall alpha of 0.025 for each primary intervention.|ANCOVA|Adjusted for baseline 6-minute walk distance||The effect of lidocaine on 6-minute walk distance on the 2nd postoperative morning was assessed using analysis of covariance. We expected the control group's mean 6-minute walk distance to be 300 meters with a standard deviation (SD) of about 20% of the mean for each group. Assuming a correlation of 0.5 between baseline and 2nd postoperative day, a maximum 128 total patients (32 for each group) was needed to have 80% power at the 0.025 significance level to detect effects of 36 meters or more.||54|-52|0.96
70941361|NCT02799745|141383291|SUPERIORITY||LS mean difference|-10.07|STANDARD_ERROR_OF_MEAN|2.398|<|0.001|TWO_SIDED|95.0|-14.79|-5.34||P-values: from differences of least squares means.Bonferroni-Holm was used in the primary hypothesis testing to adjust for multiplicity.|Mixed Models Analysis|Compound symmetry was used as the covariance structure. Covariance parameters:estimated using Restricted Maximum likelihood.|Mixed model repeated measure(MMRM) with treatment group, prostate cancer risk(low/intermediate), type of biopsy(mpMRI-targeted/non-mpMRI-targeted), visit, visit-by-treatment, baseline scores as fixed factors, site and participants as random factors.|Change at month 12||-5.34|-14.79|<0.001
71010518|NCT03451630|141527938|SUPERIORITY|||||||0.4703||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.76 with degrees of freedom (2, 612).||Test for change over time for SPD-1||||0.4703
71010519|NCT03451630|141527938|SUPERIORITY|||||||0.877||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.13 with degrees of freedom (2, 332).||Test for change in treatment effect for SPD-1||||0.8770
71010520|NCT03451630|141527938|SUPERIORITY|||||||0.6198||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.66 with degrees of freedom (4, 469).||Test for the treatment-by-time interaction (without weight) for SPD-2||||0.6198
71010521|NCT03451630|141527938|SUPERIORITY|||||||0.6211||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.48 with degrees of freedom (2, 473).||Test for change over time for SPD-2||||0.6211
71010522|NCT03451630|141527938|SUPERIORITY|||||||0.1471||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.93 with degrees of freedom (2, 219).||Test for change in treatment effect for SPD-2.||||0.1471
71010523|NCT03451630|141527939|SUPERIORITY|||||||0.8247||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.38 with degrees of freedom (4, 280).||Test for the treatment-by-time interaction (without weight) for AMM-1||||0.8247
71010524|NCT03451630|141527939|SUPERIORITY|||||||0.6651||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.41 with degrees of freedom (2, 284).||Test for change over time for AMM-1||||0.6651
71010525|NCT03451630|141527939|SUPERIORITY|||||||0.3441||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.07 with degrees of freedom (2, 218).||Test for change in treatment effect for AMM-1||||0.3441
71010526|NCT03451630|141527939|SUPERIORITY|||||||0.0847||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 2.07 with degrees of freedom (4, 280).||Test for the treatment-by-time interaction (without weight) for AMM-2||||0.0847
71010527|NCT03451630|141527939|SUPERIORITY|||||||0.9695||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.03 with degrees of freedom (2, 284).||Test for change over time for AMM-2||||0.9695
71010528|NCT03451630|141527939|SUPERIORITY|||||||0.9396||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.06 with degrees of freedom (2, 200).||Test for change in treatment effect for AMM-2||||0.9396
71010529|NCT03370133|141527948|SUPERIORITY||Odds Ratio (OR)|99.869|||<|0.001|TWO_SIDED|95.0|34.02|293.175||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.||293.175|34.020|<0.001
71010530|NCT03370133|141527948|SUPERIORITY||Odds Ratio (OR)|6.056|||<|0.001|TWO_SIDED|95.0|3.874|9.466||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.||9.466|3.874|<0.001
71010531|NCT03370133|141527949|SUPERIORITY||Odds Ratio (OR)|118.762|||<|0.001|TWO_SIDED|95.0|36.701|384.307||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.||384.307|36.701|<0.001
71010532|NCT03370133|141527949|SUPERIORITY||Odds Ratio (OR)|4.809|||<|0.001|TWO_SIDED|95.0|3.096|7.47||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.||7.470|3.096|<0.001
71046662|NCT01172821|141601986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.178|STANDARD_ERROR_OF_MEAN|0.6||0.7665|TWO_SIDED|95.0|-1.355|0.999|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.999|-1.355|0.7665
71103753|NCT00721110|141715018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0||||0.54|TWO_SIDED|97.5|-65.0|44.0||97.5% confidence interval adjusted for group sequential design (using confidence coefficient of 2.97) to maintain theoverall α of 0.025 for each primary intervention and 0.05 for the trial.|ANCOVA|Adjusted for baseline 6-minute walk distance||The effect of ketamine on 6-minute walk distance on the 2nd postoperative morning was assessed using analysis of covariance. We expected the control group's mean 6-minute walk distance to be 300 meters with a standard deviation (SD) of about 20% of the mean for each group. Assuming a correlation of 0.5 between baseline and 2nd postoperative day, a maximum 128 total patients (32 for each group) was needed to have 80% power at the 0.025 significance level to detect effects of 36 meters or more.||44|-65|0.54
71103754|NCT00721110|141715019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.2|TWO_SIDED|97.5|-3.3|1.3||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Groups compared on VRS scores at PACU admit using a t test.||1.3|-3.3|0.20
71103755|NCT00721110|141715019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.54|TWO_SIDED|97.5|-2.8|1.9||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Ketamine compared to placebo at PACU admit using a t test||1.9|-2.8|0.54
71103756|NCT00721110|141715019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.11|TWO_SIDED|97.5|-2.5|0.8||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Lidocaine versus nonlidocaine on pain severity at postoperative care unit discharge was assessed using a t test.||0.8|-2.5|0.11
71103757|NCT00721110|141715019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.56|TWO_SIDED|97.5|-1.4|2.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Ketamine versus nonketamine on postoperative care unit discharge pain severity was assessed using a t test.||2.0|-1.4|0.56
71010533|NCT03370133|141527950|SUPERIORITY||Odds Ratio (OR)|25.59|||<|0.001|TWO_SIDED|95.0|9.063|72.253||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||72.253|9.063|<0.001
71010534|NCT03370133|141527951|SUPERIORITY||Odds Ratio (OR)|25.471|||<|0.001|TWO_SIDED|95.0|9.02|71.925||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||71.925|9.020|<0.001
71010535|NCT03370133|141527952|SUPERIORITY||Odds Ratio (OR)|123.02|||<|0.001|TWO_SIDED|95.0|29.394|514.862||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||514.862|29.394|<0.001
71010536|NCT03370133|141527952|SUPERIORITY||Odds Ratio (OR)|18.202|||<|0.001|TWO_SIDED|95.0|10.998|30.123||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||30.123|10.998|<0.001
71010537|NCT03370133|141527953|SUPERIORITY||Odds Ratio (OR)|16.258|||<|0.001|TWO_SIDED|95.0|7.356|35.931||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||35.931|7.356|<0.001
71010538|NCT03370133|141527954|SUPERIORITY||Odds Ratio (OR)|22.279|||<|0.001|TWO_SIDED|95.0|9.795|50.674||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||50.674|9.795|<0.001
71010539|NCT03370133|141527955|SUPERIORITY||Odds Ratio (OR)|23.049|||<|0.001|TWO_SIDED|95.0|10.201|52.077||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||52.077|10.201|<0.001
71010540|NCT03370133|141527956|SUPERIORITY||Odds Ratio (OR)|37.696|||<|0.001|TWO_SIDED|95.0|16.92|83.987||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||83.987|16.920|<0.001
71046663|NCT01172821|141601987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.031||0.0111|TWO_SIDED|95.0|0.018|0.14|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.140|0.018|0.0111
71010541|NCT03370133|141527957|SUPERIORITY||Odds Ratio (OR)|8.047|||<|0.001|TWO_SIDED|95.0|5.107|12.679||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||12.679|5.107|<0.001
71010542|NCT03370133|141527958|SUPERIORITY||Odds Ratio (OR)|3.795|||<|0.001|TWO_SIDED|95.0|2.442|5.899||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||5.899|2.442|<0.001
71010543|NCT03370133|141527959|SUPERIORITY||Odds Ratio (OR)|4.379|||<|0.001|TWO_SIDED|95.0|2.85|6.73||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||6.730|2.850|<0.001
71010544|NCT03370133|141527960|SUPERIORITY||Odds Ratio (OR)|2.412|||<|0.001|TWO_SIDED|95.0|1.573|3.699||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||3.699|1.573|<0.001
71010545|NCT03524664|141527972|SUPERIORITY|||||||0.523||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71) = 0.411, p =.523||Repeated measures ANOVA||||.523
71010546|NCT03524664|141527973|SUPERIORITY|||||||0.173||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=1.89, p=.173||Repeated measures ANOVA||||.173
71010547|NCT03524664|141527974|SUPERIORITY|||||||0.14||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=2.23, p=.140||Outcome data analyzed for those with complete data at both timepoints.||||.140
71010548|NCT03524664|141527975|SUPERIORITY|||||||0.845||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,70)=.039, p=0.845||Outcome data analyzed for those with complete data at both timepoints.||||0.845
71010549|NCT03524664|141527976|SUPERIORITY|||||||0.147||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,70)=2.147, p=.147||Outcome data analyzed for those with complete data at both timepoints.||||.147
71010550|NCT03524664|141527977|SUPERIORITY|||||||0.429||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,70)=.633, p=.429||Outcome data analyzed for those with complete data at both timepoints.||||.429
71010551|NCT03524664|141527978|SUPERIORITY|||||||0.208||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,70)=1.618, p=.208||Outcome data analyzed for those with complete data at both timepoints.||||.208
71010552|NCT03524664|141527979|SUPERIORITY|||||||0.3||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=1.09, p=.300||Outcome data analyzed for those with complete data at both timepoints.||||.300
71010553|NCT03524664|141527980|SUPERIORITY|||||||0.099||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=2.79, p=.099||Outcome data analyzed for those with complete data at both timepoints.||||.099
71010554|NCT03524664|141527981|SUPERIORITY|||||||0.105||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=2.70, p=.105||Outcome data analyzed for those with complete data at both timepoints.||||.105
71010555|NCT03524664|141527982|SUPERIORITY|||||||0.699||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=0.15, p=.699||Repeated measures ANOVA||||.699
71010556|NCT03524664|141527983|SUPERIORITY|||||||0.945||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=0.005, p=.945||Repeated measures ANOVA||||.945
71010557|NCT03524664|141527984|SUPERIORITY|||||||0.767||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=0.088, p=.767||Repeated measures ANOVA||||.767
71010558|NCT03524664|141527985|SUPERIORITY|||||||0.682||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=.0.17, p=.682||Repeated measures ANOVA||||.682
71010559|NCT03524664|141527986|SUPERIORITY|||||||0.96||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,42)=0.003, p=.960||Repeated measures ANOVA||||.960
71010560|NCT03524664|141527987|SUPERIORITY|||||||0.643||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,42)=0.218, p=.643||Repeated measures ANOVA||||.643
71010561|NCT03524664|141527988|SUPERIORITY|||||||0.118||||||The threshold for statistical significance was p = 0.05.|ANOVA|Time X Group F(2,90)=2.19, p.118||Repeated measures ANOVA||||.118
71010562|NCT03524664|141527989|SUPERIORITY|||||||0.8||||||The threshold for statistical significance was p = 0.05.|ANOVA|Time x Group F(2,90)=.223, p=.800||Repeated measures ANOVA||||.800
71010563|NCT03524664|141527990|SUPERIORITY|||||||0.863||||||The threshold for statistical significance was p = 0.05.|ANOVA|Group x Time F(2,92)=0.148, p=.863||Repeated measures ANOVA||||.863
71010564|NCT00684073|141528007|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.42||||0.13||95.0||||p-value adjusted for treatment only|ANCOVA||Difference between treatments (Suboxone minus Subutex)estimated by ANCOVA = 0.42.|||||0.130
71010565|NCT01140646|141528023|SUPERIORITY_OR_OTHER|||||||0.0903||||||One sided t-test with 0.05 error rate was employed.|t-test, 1 sided|||To determine whether any reduction in hot flash score is beyond what is expected with a placebo (20-25%). Reference: Sloan JA, et al. Methodologic lessons learned from hot flash studies. J Clin Oncol. Dec 1 2001;19(23):4280-4290.||||0.0903
71010566|NCT01140646|141528023|SUPERIORITY_OR_OTHER|||||||0.1553||||||One sided t-test with 0.05 error rate was employed.|t-test, 1 sided|||To determine whether any reduction in hot flash frequency is beyond what is expected with a placebo (20-25%). Reference: Sloan JA, et al. Methodologic lessons learned from hot flash studies. J Clin Oncol. Dec 1 2001;19(23):4280-4290.||||0.1553
71010567|NCT00689728|141528038|SUPERIORITY_OR_OTHER|||||||0.178||95.0|||||Fisher Exact|||||||0.178
71010568|NCT00689728|141528038|SUPERIORITY_OR_OTHER|||||||0.116||95.0|||||Fisher Exact|||||||0.116
71010569|NCT00689728|141528040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.873||||0.062||95.0||||p-value represents change from baseline at 16 weeks for LY2127399 30 mg. vs. placebo in Physical Health Component scores.|ANCOVA|||||||0.062
71046664|NCT01172821|141601987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064|STANDARD_ERROR_OF_MEAN|0.031||0.0395|TWO_SIDED|95.0|0.003|0.126|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.126|0.003|0.0395
71046665|NCT01172821|141601988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.032||0.0357|TWO_SIDED|95.0|0.005|0.131|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.131|0.005|0.0357
71046666|NCT01172821|141601988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.066|STANDARD_ERROR_OF_MEAN|0.032||0.0422|TWO_SIDED|95.0|0.002|0.129|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.129|0.002|0.0422
71046667|NCT01172821|141601989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.171|STANDARD_ERROR_OF_MEAN|0.131||0.1927|TWO_SIDED|95.0|-0.427|0.086|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.086|-0.427|0.1927
71046668|NCT01172821|141601989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.109|STANDARD_ERROR_OF_MEAN|0.131||0.4053|TWO_SIDED|95.0|-0.148|0.367|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.367|-0.148|0.4053
71046669|NCT01172821|141601990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.026|STANDARD_ERROR_OF_MEAN|0.027||0.3501|TWO_SIDED|95.0|-0.079|0.028|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.028|-0.079|0.3501
71046670|NCT01172821|141601990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.028||0.8045|TWO_SIDED|95.0|-0.047|0.061|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.061|-0.047|0.8045
71046671|NCT01172821|141601991|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.0308|TWO_SIDED|95.0|1.03|1.72||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R2.5 / Placebo|||1.72|1.03|0.0308
71046672|NCT01172821|141601991|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.0348|TWO_SIDED|95.0|1.02|1.71||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|||1.71|1.02|0.0348
71046673|NCT01663727|141602002|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0007|TWO_SIDED|99.0|0.51|0.91|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratification factors were plasma VEGF-A level (low/high), prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).||0.91|0.51|0.0007
71046674|NCT01663727|141602002|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0046|TWO_SIDED|99.0|0.55|0.97|||Log Rank|||Unstratified Analysis.||0.97|0.55|0.0046
71046675|NCT01663727|141602002|SUPERIORITY_OR_OTHER|||||||0.4619|TWO_SIDED||||||Wald Test|||A stratified multivariate Cox regression model, including treatment, VEGF-A level, and interaction between treatment and VEGF-A level (low, high) as factors was used to estimate the interaction p-value of the treatment with VEGF-A level for PFS. Analysis for the interaction of treatment effect with the plasma VEGF-A levels was a secondary objective.||||0.4619
71046676|NCT01663727|141602004|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.5877|TWO_SIDED|95.0|0.75|1.18|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratified analysis: Stratification factors were plasma VEGF-A level (low/high), prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).||1.18|0.75|0.5877
71046677|NCT01663727|141602004|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.8004|TWO_SIDED|95.0|0.78|1.21|||Log Rank||Hazards ratio was estimated by Cox regression.|Unstratified analysis.||1.21|0.78|0.8004
71046678|NCT01663727|141602006|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.2745|TWO_SIDED|95.0|0.63|1.14|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratification factors were prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).||1.14|0.63|0.2745
71046679|NCT01663727|141602006|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.3616|TWO_SIDED|95.0|0.65|1.17|||Log Rank||Hazards ratio was estimated by Cox regression.|Unstratified analysis.||1.17|0.65|0.3616
71046680|NCT01663727|141602007|SUPERIORITY_OR_OTHER||Difference in Response Rates|20.78|||<|0.0001|TWO_SIDED|95.0|11.45|30.11|||Fisher|||||30.11|11.45|<0.0001
71046681|NCT01663727|141602009|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.0038|TWO_SIDED|96.0|0.47|0.88|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratification factors were prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).||0.88|0.47|0.0038
71046682|NCT01663727|141602009|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0101|TWO_SIDED|96.0|0.5|0.93|||Log Rank|||Unstratified analysis.||0.93|0.50|0.0101
71010570|NCT00689728|141528040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.427||||0.052||95.0||||p-value represents change from baseline at 16 weeks for LY2127399 80 mg. vs. placebo in Physical Health Component scores.|ANCOVA|||||||0.052
71010571|NCT00689728|141528040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.72||||0.655||95.0||||p-value represents change from baseline at 16 weeks for LY2127399 30 mg. vs. placebo in Mental Health Component scores.|ANCOVA|||||||0.655
71010572|NCT00689728|141528040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.264||||0.173||95.0||||p-value represents change from baseline at 16 weeks for LY2127399 80 mg. vs. placebo in Mental Health Component scores.|ANCOVA|||||||0.173
71010573|NCT00689728|141528041|SUPERIORITY_OR_OTHER|||||||0.281||95.0|||||Fisher Exact|||||||0.281
71010574|NCT00689728|141528041|SUPERIORITY_OR_OTHER|||||||0.218||95.0|||||Fisher Exact|||||||0.218
71010575|NCT00689728|141528042|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Fisher Exact|||||||0.500
71010576|NCT00689728|141528042|SUPERIORITY_OR_OTHER|||||||0.444||95.0|||||Fisher Exact|||||||0.444
71010577|NCT00689728|141528043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5||||0.337||95.0|||||ANCOVA|||||||0.337
71010578|NCT00689728|141528043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6||||0.038||95.0|||||ANCOVA|||||||0.038
71010579|NCT00689728|141528044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.403||95.0|||||ANCOVA|||||||0.403
71010580|NCT00689728|141528044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3||||0.006||95.0|||||ANCOVA|||||||0.006
71010581|NCT00689728|141528045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2||||0.168||95.0|||||ANCOVA|||||||0.168
71010582|NCT00689728|141528045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.3||||0.075||95.0|||||ANCOVA|||||||0.075
71010583|NCT00689728|141528046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.3||||0.157||95.0|||||ANCOVA|||||||0.157
71010584|NCT00689728|141528046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.6||||0.025||95.0|||||ANCOVA|||||||0.025
71010585|NCT00689728|141528047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.4||||0.11||95.0|||||ANCOVA|||||||0.110
71010586|NCT00689728|141528047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.1||||0.147||95.0|||||ANCOVA|||||||0.147
71010587|NCT00689728|141528048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.172||||0.969||95.0|||||ANCOVA|||||||0.969
71010588|NCT00689728|141528048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.452||95.0|||||ANCOVA|||||||0.452
71010589|NCT00689728|141528049|SUPERIORITY_OR_OTHER|||||||0.554||95.0|||||ANCOVA|||||||0.554
71010590|NCT00689728|141528049|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||ANCOVA|||||||0.920
71010591|NCT00689728|141528050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.912||||0.1||95.0|||||ANCOVA|||||||0.100
71010592|NCT00689728|141528050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.322||||0.005||95.0|||||ANCOVA|||||||0.005
71010593|NCT00689728|141528051|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||p-value represents comparison of LY2127399-30 mg dose versus placebo for the 3 levels of EULAR response (good response, moderate response, no response).|Fisher Exact|||||||0.022
71010594|NCT00689728|141528051|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||p-value represents comparison of LY2127399-80 mg dose versus placebo for the 3 levels of EULAR response (good response, moderate response, no response).|Fisher Exact|||||||0.016
71010595|NCT00689728|141528052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.818||95.0|||||ANCOVA|||||||0.818
71010596|NCT00689728|141528052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.7||||0.066||95.0|||||ANCOVA|||||||0.066
71010597|NCT00689728|141528053|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANCOVA|||||||0.010
71010598|NCT00689728|141528053|SUPERIORITY_OR_OTHER|||||||0.056||95.0|||||ANCOVA|||||||0.056
71010599|NCT00689728|141528054|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||||||0.001
71010600|NCT00689728|141528054|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||ANCOVA|||||||0.015
71010601|NCT00689728|141528055|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||p-value is for Immunoglobulin G change at week 16 (LOCF)|ANCOVA|||||||0.146
71010602|NCT00689728|141528055|SUPERIORITY_OR_OTHER|||||||0.125||95.0||||p-value is for Immunoglobulin G change at week 16 (LOCF)|ANCOVA|||||||0.125
71010603|NCT00689728|141528055|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Immunoglobulin M change at week 16 (LOCF)|ANCOVA|||||||<0.001
71010604|NCT00689728|141528055|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||p-value is for Immunoglobulin M change at week 16 (LOCF)|ANCOVA|||||||0.005
71010605|NCT00689728|141528055|SUPERIORITY_OR_OTHER|||||||0.115||95.0||||p-value is for Immunoglobulin A change at week 16 (LOCF)|ANCOVA|||||||0.115
71010606|NCT00689728|141528055|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||p-value is for Immunoglobulin A change at week 16 (LOCF)|ANCOVA|||||||0.019
71010607|NCT03245372|141528058|SUPERIORITY|||||||0.114|||||||Wilcoxon (Mann-Whitney)|||||||0.114
71010608|NCT03245372|141528059|SUPERIORITY|||||||0.692|||||||Wilcoxon (Mann-Whitney)|||||||0.692
71010609|NCT03245372|141528060|SUPERIORITY|||||||0.082|||||||t-test, 2 sided|||||||0.082
71010610|NCT03245372|141528061|SUPERIORITY|||||||0.443|||||||Wilcoxon (Mann-Whitney)|||||||0.443
71010611|NCT03245372|141528062|SUPERIORITY|||||||0.668|||||||t-test, 2 sided|||||||0.668
71010612|NCT03245372|141528063|SUPERIORITY|||||||0.516|||||||Chi-squared|||||||0.516
71010613|NCT03245372|141528065|SUPERIORITY|||||||0.229|||||||Wilcoxon (Mann-Whitney)|||||||0.229
71010614|NCT03245372|141528066|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
71010615|NCT04047342|141528067|SUPERIORITY||Odds Ratio (OR)|0.97||||0.828|TWO_SIDED|95.0|0.72|1.3||We used an a priori threshold of p \< .05.|Regression, Logistic|||||1.30|0.72|.828
71010616|NCT00660829|141528073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5633|STANDARD_DEVIATION|0.3345|<|0.001||95.0|-2.22|-0.91|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.91|-2.22|<0.001
71010617|NCT00660829|141528074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7444|STANDARD_ERROR_OF_MEAN|0.1677|<|0.001||95.0|-1.07|-0.42|||ANOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.42|-1.07|<0.001
71010618|NCT00660829|141528075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4403|STANDARD_DEVIATION|0.3406|<|0.001||95.0|-2.11|-0.77|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.77|-2.11|<0.001
70928611|NCT04800211|141353079|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-2.382|||<|0.0001|TWO_SIDED|95.0|-2.673|-2.09|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-2.090|-2.673|<.0001
71046683|NCT01663727|141602010|SUPERIORITY_OR_OTHER||Difference in Response Rates|21.53||||0.0017|TWO_SIDED|95.0|8.73|34.32|||Fisher|||||34.32|8.73|0.0017
71046684|NCT01663727|141602011|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.2737|TWO_SIDED|95.0|0.54|1.19|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratification factors were plasma VEGF-A level (low/high), prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).||1.19|0.54|0.2737
71046685|NCT01663727|141602011|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.2959|TWO_SIDED|95.0|0.56|1.19|||Log Rank||Hazards ratio was estimated by Cox regression.|Unstratified analysis.||1.19|0.56|0.2959
71046686|NCT01663727|141602012|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.1783|TWO_SIDED|95.0|0.41|1.18|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratification factors were prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).||1.18|0.41|0.1783
71046687|NCT01663727|141602012|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.2429|TWO_SIDED|95.0|0.45|1.22|||Log Rank||Hazards ratio was estimated by Cox regression.|Unstratified analysis.||1.22|0.45|0.2429
71046688|NCT04495283|141602040|SUPERIORITY||LS Mean Difference|-114.43|STANDARD_ERROR_OF_MEAN|26.65|<|0.001|ONE_SIDED|90.0||-80.01|||ANOVA|||||-80.01||<0.001
71046689|NCT04495283|141602041|SUPERIORITY||LS Mean Difference|-70.16|STANDARD_ERROR_OF_MEAN|21.549|<|0.001|ONE_SIDED|90.0||-42.32|||ANOVA|||||-42.32||<0.001
71046690|NCT02246439|141602087|SUPERIORITY||Odds Ratio (OR)|1.6081||||0.0406|TWO_SIDED|95.0|1.0194|2.5368||"This P-Value is for the All ages group"|Cochran-Mantel-Haenszel|Stratified by age.||The odds ratio and p-value were from a Cochran-Mantel-Haenszel test. For the 'All ages' category, the odds ratio and p-value were stratified by age.||2.5368|1.0194|0.0406
71046691|NCT02246439|141602087|SUPERIORITY||Odds Ratio (OR)|4.8||||0.0729|TWO_SIDED|95.0|0.847|27.2024||"This P-Value is for the \<18 years of age group."|Cochran-Mantel-Haenszel|||||27.2024|0.8470|0.0729
71046692|NCT02246439|141602087|SUPERIORITY||Odds Ratio (OR)|1.4755||||0.1089|TWO_SIDED|95.0|0.917|2.3741||"This P-Value is for the 18 years of age and older group"|Cochran-Mantel-Haenszel|||||2.3741|0.9170|0.1089
71046693|NCT02246439|141602088|SUPERIORITY||Odds Ratio (OR)|1.3545||||0.1843|TWO_SIDED|95.0|0.8647|2.1216|||Cochran-Mantel-Haenszel|Stratified by age.||||2.1216|0.8647|0.1843
71046694|NCT02246439|141602089|SUPERIORITY||Odds Ratio (OR)|1.752||||0.0166|TWO_SIDED|95.0|1.1058|2.776|||Cochran-Mantel-Haenszel|Stratified by age.||||2.7760|1.1058|0.0166
71046695|NCT02246439|141602090|SUPERIORITY||Odds Ratio (OR)|0.6677||||0.1049|TWO_SIDED|95.0|0.4093|1.0892|||Cochran-Mantel-Haenszel|Stratified by age.||||1.0892|0.4093|0.1049
71046696|NCT02246439|141602091|SUPERIORITY||Odds Ratio (OR)|0.6566||||0.1235|TWO_SIDED|95.0|0.3826|1.1268|||Cochran-Mantel-Haenszel|Stratified by age.||||1.1268|0.3826|0.1235
71046697|NCT02246439|141602093|SUPERIORITY|||||||0.589||||||This P-Value is for the BSS=7 group.|Wilcoxon (Mann-Whitney)|||||||0.5890
71046698|NCT02246439|141602094|SUPERIORITY||Hazard Ratio (HR)|0.9782||||0.8487|TWO_SIDED|95.0|0.7803|1.2264||"This P-Value is for the All ages group."|Cox proportioanl hazards method|Stratified by age.||||1.2264|0.7803|0.8487
71046699|NCT02246439|141602094|SUPERIORITY||Hazard Ratio (HR)|1.4756||||0.3479|TWO_SIDED|95.0|0.6549|3.325||"This P-Value is for the \<18 years of age group."|Cox proportional hazards method|||||3.3250|0.6549|0.3479
71046700|NCT02246439|141602094|SUPERIORITY||Hazard Ratio (HR)|0.9445||||0.6332|TWO_SIDED|95.0|0.7469|1.1943||"This P-Value is for the 18 years of age of older group."|Cox proportional hazards method|||||1.1943|0.7469|0.6332
71046701|NCT02246439|141602095|SUPERIORITY||Hazard Ratio (HR)|1.0275||||0.8289|TWO_SIDED|95.0|0.8036|1.3138||"This P-Value was for the All ages group."|Cox proportional hazards method|Stratified by age.||||1.3138|0.8036|0.8289
71046702|NCT02246439|141602095|SUPERIORITY||Hazard Ratio (HR)|1.5744||||0.3241|TWO_SIDED|95.0|0.6388|3.8802||"This P-Value is for the \<18 years of age group."|Cox proportional hazards method|||||3.8802|0.6388|0.3241
71046703|NCT02246439|141602095|SUPERIORITY||Hazard Ratio (HR)|0.992||||0.9511|TWO_SIDED|95.0|0.7688|1.2801||"This P-Value is for the 18 years of age or older group."|Cox proportional hazards method|||||1.2801|0.7688|0.9511
71046704|NCT02246439|141602096|SUPERIORITY||Odds Ratio (OR)|2.3012||||0.2005|TWO_SIDED|95.0|0.6221|8.5129|||Cochran-Mantel-Haenszel|||||8.5129|0.6221|0.2005
71046705|NCT02246439|141602097|SUPERIORITY||Odds Ratio (OR)|0.6674||||0.572|TWO_SIDED|95.0|0.1638|2.7191|||Cochran-Mantel-Haenszel|||||2.7191|0.1638|0.5720
71046706|NCT02246439|141602098|SUPERIORITY||Odds Ratio (OR)|2.1591||||0.3186|TWO_SIDED|95.0|0.477|9.7735||"This P-Value is for the No nausea or mild nausea group."|Cochran-Mantel-Haenszel|Stratified by age.||||9.7735|0.4770|0.3186
71046707|NCT02246439|141602098|SUPERIORITY||Odds Ratio (OR)|1.575||||0.3473|TWO_SIDED|95.0|0.6096|4.0696||"This P-Value is for the Moderate nausea group."|Cochran-Mantel-Haenszel|Stratified by age.||||4.0696|0.6096|0.3473
71046708|NCT02246439|141602098|SUPERIORITY||Odds Ratio (OR)|2.0971||||0.0633|TWO_SIDED|95.0|0.9614|4.5747||"This P-Value is for the Severe nausea group."|Cochran-Mantel-Haenszel|Stratified by age.||||4.5747|0.9614|0.0633
71046709|NCT02246439|141602098|SUPERIORITY||Odds Ratio (OR)|1.6397||||0.2797|TWO_SIDED|95.0|0.6649|4.0437||"This P-Value is for the Nausea as bad as it could have been group."|Cochran-Mantel-Haenszel|Stratified by age.||||4.0437|0.6649|0.2797
71010619|NCT00660829|141528076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2907|STANDARD_DEVIATION|0.3204|<|0.001||95.0|-1.92|0.66|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline||0.66|-1.92|<0.001
71046710|NCT02246439|141602099|SUPERIORITY||Odds Ratio (OR)|1.8673||||0.0103|TWO_SIDED|95.0|1.1572|3.0131||"This P-Value is for the All ages group."|Cochran-Mantel-Haenszel|Stratified by age.||||3.0131|1.1572|0.0103
71010620|NCT00660829|141528077|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANCOVA|||Change from baseline||||0.001
71010621|NCT00280059|141528108|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin for the proportion of seizure free participants set at 10%; non-inferiority declared if the lower bound of the 95% confidence interval (CI) of the difference in seizure-free proportion between pregabalin and lamotrigine was no more than 10% in favor of lamotrigine, but 0 was contained within the lower bound of the CI. Interpretation of superiority required lower bound of CI did not contain 0 in favor of pregabalin.|Mean Difference (Final Values)|-0.16|||||TWO_SIDED|95.0|-0.24|-0.09|||Gart and Nam: correction of skewness||95% confidence interval for the true difference in proportions, as well as a one-sided test at α=0.025; confidence interval adjusted for centers clustered within a geographical region, with upper and lower confidence limits.|Analysis of the binary response variable for 6 consecutive months seizure freedom analyzed by comparing the proportions of favorable responders between the two treatment groups after stratifying by clusters and correcting for skewness (Gart and Nam, 1990). Percentage can be obtained by multiplying proportion by 100.||-0.09|-0.24|
71010622|NCT00280059|141528109|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.74||||0.0034|TWO_SIDED|95.0|0.6|0.9||Nominal value for 2-sided test calculated using Cox proportional hazards model, adjusted for geographic regions.|Regression, Cox|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \> 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.||0.90|0.60|0.0034
71010623|NCT00280059|141528110|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.06||||0.8047|TWO_SIDED|95.0|0.65|1.74||Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.|Cox proportional hazards model|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \< 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.||1.74|0.65|0.8047
71010624|NCT00280059|141528111|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.19||||0.2537|TWO_SIDED|95.0|0.88|1.6||Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.|Cox proportional hazards model|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \< 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.||1.60|0.88|0.2537
71010625|NCT00280059|141528112|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|6.52||||0.0025|TWO_SIDED|95.0|1.93|22.04||Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.|Cox proportional hazards model|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \< 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.||22.04|1.93|0.0025
71010626|NCT00280059|141528113|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.36||||0.0744|TWO_SIDED|95.0|0.97|1.91||Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.|Cox proportional hazards model|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \< 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.||1.91|0.97|0.0744
71046711|NCT02246439|141602099|SUPERIORITY||Odds Ratio (OR)|4.4||||0.0934|TWO_SIDED|95.0|0.7699|25.145||"This P-Value is for the \<18 years of age group."|Cochran-Mantel-Haenszel|||||25.1450|0.7699|0.0934
71010627|NCT00280059|141528114|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.47||||0.0003|TWO_SIDED|95.0|1.19|1.8||Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.|Cox proportional hazards model|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \< 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.||1.80|1.19|0.0003
71010628|NCT00280059|141528124|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8||||0.0025|TWO_SIDED|95.0|0.3|1.4|||ANCOVA|||Anxiety; model includes treatment and geographical cluster as fixed effects and respective baseline scores as a continuous covariate.||1.4|0.3|0.0025
71046712|NCT02246439|141602099|SUPERIORITY||Odds Ratio (OR)|1.7356||||0.0303|TWO_SIDED|95.0|1.0527|2.8615||"This P-Value is for the 18 years of age or older group."|Cochran-Mantel-Haenszel|||||2.8615|1.0527|0.0303
71010629|NCT00280059|141528124|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6||||0.0186|TWO_SIDED|95.0|0.1|1.1|||ANCOVA|||Depression; model includes treatment and geographical cluster as fixed effects and respective baseline scores as a continuous covariate.||1.1|0.1|0.0186
71046713|NCT02246439|141602100|SUPERIORITY||Odds Ratio (OR)|4.4||||0.0924|TWO_SIDED|95.0|0.7699|25.145||"This P-Value is for the \<18 years of age group."|Cochran-Mantel-Haenszel|||||25.1450|0.7699|0.0924
71046714|NCT02246439|141602100|SUPERIORITY||Odds Ratio (OR)|1.7356||||0.0303|TWO_SIDED|95.0|1.0527|2.8615||"This P-Value is for the 18 years of age or older group."|Cochran-Mantel-Haenszel|||||2.8615|1.0527|0.0303
71046715|NCT02246439|141602101|SUPERIORITY||Odds Ratio (OR)|1.7922||||0.0152|TWO_SIDED|95.0|1.1188|2.871|||Regression, Logistic|||||2.8710|1.1188|0.0152
71046716|NCT02246439|141602102|SUPERIORITY||Odds Ratio (OR)|2.0789||||0.0037|TWO_SIDED|95.0|1.2676|3.4095|||Regression, Logistic|||||3.4095|1.2676|0.0037
71046717|NCT00380692|141602130|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.7|STANDARD_ERROR_OF_MEAN|1.7|<|0.001||95.0|-10.0|-3.4||P-value for treatment group differences over time.|Mixed Models Analysis|||||-3.4|-10.0|<0.001
70928612|NCT04800211|141353079|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.486|||<|0.0001|TWO_SIDED|95.0|-2.782|-2.19|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-2.190|-2.782|<.0001
70928613|NCT04800211|141353079|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.45|||<|0.0001|TWO_SIDED|95.0|-2.668|-2.233|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-2.233|-2.668|<.0001
71046718|NCT00380692|141602131|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.921||95.0|-0.5|0.4||P-value for treatment differences over time.|Mixed Models Analysis|||||0.4|-0.5|0.921
71046719|NCT00380692|141602132|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.61||0.369||95.0|-1.8|0.7||P-value for treatment differences in Oppositional Score at 8 weeks.|ANCOVA|||||0.7|-1.8|0.369
71046720|NCT00380692|141602132|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|STANDARD_ERROR_OF_MEAN|0.87||0.024||95.0|-3.7|-0.3||P-value for treatment differences in Hyperactivity score at 8 weeks|ANCOVA|||||-0.3|-3.7|0.024
71046721|NCT00380692|141602132|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.51||0.179||95.0|-1.7|0.3||P-value for treatment differences in Cognititve/Attention score at 8 weeks.|ANCOVA|||||0.3|-1.7|0.179
71046722|NCT00380692|141602132|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7|STANDARD_ERROR_OF_MEAN|1.48||0.077||95.0|-5.6|0.3||P-value for treatment differences in ADHD score at 8 weeks|ANCOVA|||||0.3|-5.6|0.077
71046723|NCT00380692|141602134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.028||95.0|-1.0|-0.1||P-value for treatment differences in Time to fall asleep score at 8 weeks.|ANCOVA|||||-0.1|-1.0|0.028
71046724|NCT00380692|141602134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.407||95.0|-0.3|0.9||P-value for treatment differences in Difficulty falling asleep score at 8 weeks.|ANCOVA|||||0.9|-0.3|0.407
71046725|NCT00380692|141602134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.652||95.0|-0.6|0.4||P-value for treatment differences in Total hours of sleep score at 8 weeks.|ANCOVA|||||0.4|-0.6|0.652
71046726|NCT00380692|141602134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|0.49||0.112||95.0|-1.7|0.2||P-value for treatment differences in Quality of sleep score at 8 weeks.|ANCOVA|||||0.2|-1.7|0.112
71046727|NCT00380692|141602134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|0.87||0.188||95.0|-2.9|0.6||P-value for treatment differences in Functional outcome during day score at 8 weeks.|ANCOVA|||||0.6|-2.9|0.188
71046728|NCT00380692|141602135|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|1.29||0.452||95.0|-3.5|1.6||P-value for treatment differences in Irritability score at 8 weeks.|ANCOVA|||||1.6|-3.5|0.452
71046729|NCT00380692|141602135|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|1.1||0.85||95.0|-2.4|2.0||P-value for treatment differences in Lethargy score at 8 weeks.|ANCOVA|||||2.0|-2.4|0.850
71046730|NCT00380692|141602135|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6|STANDARD_ERROR_OF_MEAN|0.63||0.014||95.0|-2.8|-0.3||P-value for treatment differences in Stereotypic score at 8 weeks.|ANCOVA|||||-0.3|-2.8|0.014
71046731|NCT00380692|141602135|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.4|STANDARD_ERROR_OF_MEAN|1.68||0.01||95.0|-7.8|-1.1||P-value for treatment differences in Hyperactivity score at 8 weeks.|ANCOVA|||||-1.1|-7.8|0.010
71046732|NCT00380692|141602135|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|0.42||0.045||95.0|-1.7|0.0||P-value for treatment differences in Inappropriate speech score at 8 weeks.|ANCOVA|||||-0.0|-1.7|0.045
71046733|NCT00380692|141602136|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.9|STANDARD_ERROR_OF_MEAN|2.13||0.069||95.0|-8.1|0.3||P-value for treatment differences in Total score at 8 weeks.|ANCOVA|||||0.3|-8.1|0.069
71046734|NCT00380692|141602137|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.64||0.598||95.0|-1.6|0.9||P-value for treatment differences in Total score at 8 weeks.|ANCOVA|||||0.9|-1.6|0.598
71046735|NCT00380692|141602138|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.2|STANDARD_ERROR_OF_MEAN|11.12||0.318||95.0|-33.3|11.0||P-value for treatment differences in Total score at 8 weeks.|ANCOVA|||||11.0|-33.3|0.318
71046736|NCT00380692|141602139|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|2.7||0.948||95.0|-5.5|5.2||P-value for treatment differences in Error Rate over time.|Mixed Models Analysis|||||5.2|-5.5|0.948
71046737|NCT00380692|141602139|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9|STANDARD_ERROR_OF_MEAN|3.5||0.399||95.0|-9.7|3.9||P-value for Treatment\*Condition Error Rate irrelevant targets over time.|Mixed Models Analysis|||||3.9|-9.7|0.399
71010630|NCT00280059|141528125|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.0683|TWO_SIDED|95.0|0.98|1.93|||Regression, Logistic|||Week 8: dichotomized sleep assessment analyzed using a logistic regression model for repeated measures with fixed effects for treatment, geographical region, the average hours per night of sleep at baseline as a continuous covariate, time, and treatment-by-time interaction. The within subject covariance structure assumes an auto-regressive of order one covariance structure.||1.93|0.98|0.0683
71010631|NCT00280059|141528125|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.14||||0.5096|TWO_SIDED|95.0|0.78|1.66|||Regression, Logistic|||Week 32: dichotomized sleep assessment analyzed using a logistic regression model for repeated measures with fixed effects for treatment, geographical region, the average hours per night of sleep at baseline as a continuous covariate, time, and treatment-by-time interaction. The within subject covariance structure assumes an auto-regressive of order one covariance structure.||1.66|0.78|0.5096
71010632|NCT00280059|141528125|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09||||0.6804|TWO_SIDED|95.0|0.73|1.63|||Regression, Logistic|||Week 56 (termination): dichotomized sleep assessment analyzed using a logistic regression model for repeated measures with fixed effects for treatment, geographical region, the average hours per night of sleep at baseline as a continuous covariate, time, and treatment-by-time interaction. The within subject covariance structure assumes an auto-regressive of order one covariance structure.||1.63|0.73|0.6804
71010633|NCT00951912|141528153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7981|STANDARD_ERROR_OF_MEAN|2.422|<|0.05|TWO_SIDED|95.0|-6.6569|5.0607|||ANOVA|||"Null hypothesis: There are no difference in the difference of changes in plasma glucose.~Power calculation: The sample size of 55 subjects per group provided about 90% power to detect a significant change in the FG concentration of 8 mg/dL (7%) by using a general assumption of a 2-tailed a level of 0.05 and allowing for a 20% withdrawal rate."||5.0607|-6.6569|<0.05
71010634|NCT00951912|141528153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.0842|STANDARD_ERROR_OF_MEAN|2.411|<|0.05|TWO_SIDED|95.0|-2.7486|8.9171|||ANOVA|||||8.9171|-2.7486|<0.05
71010635|NCT00951912|141528153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.8823|STANDARD_ERROR_OF_MEAN|2.399|<|0.05|TWO_SIDED|95.0|-1.9234|9.6881|||ANOVA|||||9.6881|-1.9234|<0.05
71010636|NCT00951912|141528154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7696|STANDARD_ERROR_OF_MEAN|4.2|<|0.05|TWO_SIDED|95.0|-11.9308|8.3916|||ANOVA|||||8.3916|-11.9308|<0.05
71010637|NCT00951912|141528154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6929|STANDARD_ERROR_OF_MEAN|4.1818|<|0.05|TWO_SIDED|95.0|-9.4232|10.8091|||ANOVA|||||10.8091|-9.4232|<0.05
71010638|NCT00951912|141528154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.4626|STANDARD_ERROR_OF_MEAN|4.1624|<|0.05|TWO_SIDED|95.0|-7.6067|12.5318|||ANOVA|||||12.5318|-7.6067|<0.05
71010639|NCT00951912|141528155|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01174|STANDARD_ERROR_OF_MEAN|1.45967|<|0.05|TWO_SIDED|95.0|-3.5428|3.5194|||ANOVA|||||3.5194|-3.5428|<0.05
71010640|NCT00951912|141528155|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.68659|STANDARD_ERROR_OF_MEAN|1.4532|<|0.05|TWO_SIDED|95.0|-6.202|0.8288|||ANOVA|||||0.8288|-6.2020|<0.05
71046738|NCT00380692|141602139|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.7|STANDARD_DEVIATION|3.1||0.57||95.0|-4.3|7.8||P-value for Treatment\*Condition Error Rate relevant nontargets over time.|Mixed Models Analysis|||||7.8|-4.3|0.570
71046739|NCT00380692|141602140|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-61.9|STANDARD_ERROR_OF_MEAN|66.0||0.352||95.0|-193.5|69.8||P-value for Treatment differences in Reaction time over time.|Mixed Models Analysis|||||69.8|-193.5|0.352
71046740|NCT00380692|141602140|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-37.1|STANDARD_ERROR_OF_MEAN|62.3||0.553||95.0|-160.3|86.2||P-value for Treatment\*Condition Mean Reaction Time correct rejections irrelevant target over time.|Mixed Models Analysis|||||86.2|-160.3|0.553
71010641|NCT00951912|141528155|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.67485|STANDARD_ERROR_OF_MEAN|1.44646|<|0.05|TWO_SIDED|95.0|-6.174|0.8243|||ANOVA|||||0.8243|-6.174|<0.05
71010642|NCT00951912|141528156|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9661|STANDARD_ERROR_OF_MEAN|3.14977|<|0.05|TWO_SIDED|95.0|-10.5857|4.6535|||ANOVA|||||4.6535|-10.5857|<0.05
71010643|NCT00951912|141528156|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.9972|STANDARD_ERROR_OF_MEAN|3.13581|<|0.05|TWO_SIDED|95.0|-8.583|6.5886|||ANOVA|||||6.5886|-8.5830|<0.05
71010644|NCT00951912|141528156|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.9689|STANDARD_ERROR_OF_MEAN|3.12126|<|0.05|TWO_SIDED|95.0|-5.5817|9.5195|||ANOVA|||||9.5195|-5.5817|<0.05
71010645|NCT00951912|141528157|SUPERIORITY_OR_OTHER||Mean Rank|1.442|||<|0.05|||||||Kruskal-Wallis|||||||<0.05
71010646|NCT00951912|141528158|SUPERIORITY_OR_OTHER||Mean Ranks|1.895|||<|0.05|||||||Kruskal-Wallis|||||||<0.05
71010647|NCT00951912|141528159|SUPERIORITY_OR_OTHER||Mean Ranks|2.169|||<|0.05|||||||Kruskal-Wallis|||||||<0.05
71010648|NCT00951912|141528160|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.437|STANDARD_ERROR_OF_MEAN|4.9113|<|0.05|TWO_SIDED|95.0|-8.444|15.318|||ANOVA|||||15.318|-8.444|<0.05
71010649|NCT00951912|141528160|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.4809|STANDARD_ERROR_OF_MEAN|4.8896|<|0.05|TWO_SIDED|95.0|-8.3475|15.3092|||ANOVA|||||15.3092|-8.3475|<0.05
71010650|NCT00951912|141528160|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0439|STANDARD_ERROR_OF_MEAN|4.8669|<|0.05|TWO_SIDED|95.0|-11.7296|11.8174|||ANOVA|||||11.8174|-11.7296|<0.05
71010651|NCT00951912|141528161|SUPERIORITY_OR_OTHER||Mean ranks|1.031|||<|0.05|||||||Kruskal-Wallis|||||||<0.05
71010652|NCT00951912|141528162|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8185|STANDARD_ERROR_OF_MEAN|3.2343|<|0.05|TWO_SIDED|95.0|-6.0057|9.6426|||ANOVA|||||9.6426|-6.0057|<0.05
71010653|NCT00951912|141528162|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0276|STANDARD_ERROR_OF_MEAN|3.2199|<|0.05|TWO_SIDED|95.0|-6.7619|8.817|||ANOVA|||||8.8170|-6.7619|<0.05
71010654|NCT00951912|141528162|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7909|STANDARD_ERROR_OF_MEAN|3.205|<|0.05|TWO_SIDED|95.0|-8.5442|6.9624|||ANOVA|||||6.9624|-8.5442|<0.05
71010655|NCT00951912|141528163|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0122|STANDARD_ERROR_OF_MEAN|4.1686|<|0.05|TWO_SIDED|95.0|-8.0721|12.0964|||ANOVA|||||12.0964|-8.0721|<0.05
71010656|NCT00951912|141528163|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7716|STANDARD_ERROR_OF_MEAN|4.1501|<|0.05|TWO_SIDED|95.0|-10.8111|9.2679|||ANOVA|||||9.2679|-10.8111|<0.05
71046741|NCT00380692|141602140|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.0|STANDARD_ERROR_OF_MEAN|57.7||0.904||95.0|-107.1|121.1||P-value for Treatment\*Condition Mean Reaction Time correct rejections relevant nontarget over time.|Mixed Models Analysis|||||121.1|-107.1|0.904
71010657|NCT00951912|141528163|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7837|STANDARD_ERROR_OF_MEAN|4.1309|<|0.05|TWO_SIDED|95.0|-12.7767|7.2092|||ANOVA|||||7.2092|-12.7767|<0.05
71010658|NCT00951912|141528164|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4437|STANDARD_ERROR_OF_MEAN|0.1001|<|0.05|TWO_SIDED|95.0|-0.6416|-0.2458|||ANOVA|||||-0.2458|-0.6416|<0.05
71010659|NCT00951912|141528164|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1986|STANDARD_ERROR_OF_MEAN|0.09986|<|0.05|TWO_SIDED|95.0|-0.3956|-0.0016|||ANOVA|||||-0.0016|-0.3956|<0.05
71010660|NCT00951912|141528164|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2451|STANDARD_ERROR_OF_MEAN|0.09648|<|0.05|TWO_SIDED|95.0|0.0544|0.4358|||ANOVA|||||0.4358|0.0544|<0.05
71010661|NCT00951912|141528165|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6353|STANDARD_ERROR_OF_MEAN|0.1146|<|0.05|TWO_SIDED|95.0|-0.8617|-0.4089|||ANOVA|||||-0.4089|-0.8617|<0.05
71010662|NCT00951912|141528165|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0282|STANDARD_ERROR_OF_MEAN|0.1156||0.05|TWO_SIDED|95.0|-0.2003|0.2568|||ANOVA|||||0.2568|-0.2003|0.05
71010663|NCT00951912|141528165|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6635|STANDARD_ERROR_OF_MEAN|0.1121|<|0.05|TWO_SIDED|95.0|0.4419|0.8851|||ANOVA|||||0.8851|0.4419|<0.05
71010664|NCT00951912|141528166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1557|STANDARD_ERROR_OF_MEAN|0.119|<|0.05||95.0|-0.3911|0.0796|||ANOVA|||||0.0796|-0.3911|<0.05
71010665|NCT00951912|141528166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.606|STANDARD_ERROR_OF_MEAN|0.119||0.05|TWO_SIDED|95.0|-0.8414|-0.3707|||ANOVA|||||-0.3707|-0.8414|0.05
71010666|NCT00951912|141528166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4503|STANDARD_ERROR_OF_MEAN|0.1163|<|0.05|TWO_SIDED|95.0|-0.6804|-0.2202|||ANOVA|||||-0.2202|-0.6804|<0.05
71010667|NCT00951912|141528167|SUPERIORITY_OR_OTHER||Mean Difference (Net)|102.4|STANDARD_ERROR_OF_MEAN|83.4|<|0.05|TWO_SIDED|95.0|-99.3|304.1|||ANOVA|||||304.1|-99.3|<0.05
71010668|NCT00951912|141528167|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.8|STANDARD_ERROR_OF_MEAN|82.6||0.05|TWO_SIDED|95.0|-203.7|196.1|||ANOVA|||||196.1|-203.7|0.05
71010669|NCT00951912|141528167|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-106.2|STANDARD_ERROR_OF_MEAN|82.2|<|0.05|TWO_SIDED|95.0|-305.1|92.8|||ANOVA|||||92.8|-305.1|<0.05
71010670|NCT02612194|141528224|OTHER|Estimation only.|Overall Response Rate|0.0|||||TWO_SIDED|95.0|0.0|0.369|||||Confidence interval estimated using the Clopper Pearson method.|||0.369|0.000|
71010671|NCT02612194|141528225|OTHER|Estimation only|Median|3.1|||||TWO_SIDED|95.0|0.2|6.1|||||The Kaplan Meier method was used to estimate the median OS (in months) for the population. The Greenwood method was used to estimate the confidence limits of the median overall survival.|||6.1|0.2|
71010672|NCT02612194|141528226|OTHER|Estimation only|Median|1.5|||||TWO_SIDED|95.0|0.2|1.8|||||The Kaplan Meier method was used to estimate the median PFS (in months) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||1.8|0.2|
71010673|NCT02539160|141528227|SUPERIORITY||Median Difference (Net)|6.4||||0.105|TWO_SIDED|95.0|-1.1|14.3|||t-test, 2 sided|||||14.3|-1.1|0.105
71010674|NCT02539160|141528227|SUPERIORITY||Mean Difference (Final Values)|6.0||||0.112|TWO_SIDED|95.0|-1.5|13.7|||t-test, 2 sided|||||13.7|-1.5|0.112
71010675|NCT02312934|141528258|OTHER||||||=|0.41||||||All pairwise comparisons were Sidak corrected for multiple comparisons at the p \< 0.05 level.|Mixed Models Analysis|Degrees of freedom were corrected using Greenhouse-Geisser estimates of sphericity (ε = 0.72).||For the Primary Aim (Specific Aim 1), a mixed-models repeated measures ANOVA was used to assess the interaction of treatment group (nicotine, placebo) with time (Visit), using change from baseline PCI FACT-Cog score (Visit 3, Visit 4, and Visit 5) as the dependent measure.||||=0.41
71010676|NCT02312934|141528259|OTHER|||||||0.79||||||All pairwise comparisons were Sidak corrected for multiple comparisons at the p \< 0.05 level.|Mixed Models Analysis|Degrees of freedom were corrected using Greenhouse-Geisser estimates of sphericity (ε = 0.72).||For the Secondary Aim (Specific Aim 2), a mixed-models repeated measures ANOVA was used to assess the interaction of treatment group (nicotine, placebo) with time (Visit), using change from baseline CPT Scores (Visit 3, Visit 4, and Visit 5) as the dependent measure.||||0.79
71010677|NCT02978339|141528260|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||.03
71010678|NCT02978339|141528261|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||||||0.59
71010679|NCT02978339|141528262|SUPERIORITY|||||||0.91|||||||t-test, 2 sided|||||||0.91
71010680|NCT02978339|141528263|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
71010681|NCT02978339|141528264|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||.15
71010682|NCT02978339|141528265|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||.06
71010683|NCT02978339|141528266|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||||||.93
71010684|NCT00689299|141528270|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||ANOVA with baseline score as covariate||||<0.05
71010685|NCT03395704|141528325|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||< 0.0001
71010686|NCT00758394|141528329|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Two way Anova general linear model (subject and treatment as factors). Multiple comparison completed to determine differences between groups.|ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
71010687|NCT03539900|141528337|SUPERIORITY|Analyses used all available data. Analyses to compare treatments were all intent-to-treat.||||||0.44|||||||Mixed Models Analysis|Analyses were performed for all randomized participants. Models also considered weight status as a moderator or predictor.||||||.44
71010688|NCT03539900|141528338|SUPERIORITY|Analyses used all available data. Analyses to compare treatments were all intent-to-treat.||||||0.04|||||||Mixed Models Analysis|Analyses were performed for all randomized participants. Models also considered weight status as a predictor or moderator.||||||.04
71010689|NCT03539900|141528339|SUPERIORITY|||||||0.98|||||||ANOVA|Analyses used all available data without imputation.||||||.98
71010690|NCT03539900|141528340|SUPERIORITY|||||||0.44|||||||ANOVA|Analyses used all available data without imputation.||||||.44
71010691|NCT03539900|141528341|SUPERIORITY|||||||0.99|||||||ANOVA|Analyses used all available data without imputation.||||||.99
71010692|NCT03539900|141528342|SUPERIORITY|||||||0.4|||||||ANOVA|Analyses used all available data without imputation.||||||.40
71046742|NCT00380692|141602141|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.3|STANDARD_ERROR_OF_MEAN|65.9||0.748||95.0|-152.8|110.3||P-value for Treatment differences in Standard Deviation of Reaction Time over time.|Mixed Models Analysis|||||110.3|-152.8|0.748
71010693|NCT04823494|141528343|NON_INFERIORITY|For sample size in each sequence group is 16 (total N=32), a 2 X 2 crossover design will have 80% power to reject the null hypothesis that the SELF-FIT APHAB mean is inferior to the PRO-FIT APHAB mean. The non-inferiority difference margin is 8.4, the standard deviation of differences is 16.3, and p\<.025. The non-inferiority margin of 8.4 preserves half the 95% critical difference for the global APHAB score (16.8). The common standard deviation reported for the APHAB global score is 16.0.|Mean Difference (Final Values)|1.4|||<|0.025|TWO_SIDED|95.0|-1.59|4.73||There were two outcome measures, primary and secondary, considered. As a result, the a priori p value of .05 for statistical significance was adjusted for multiple comparisons to .025.|t-test, 1 sided|The mean differences and 95% CIs in APHAB global score between SELF-FIT and PRO-FIT were calculated using bias-corrected \& accelerated bootstrapping.|The mean difference and 95% CIs are for Self-Fit minus Pro-Fit aided scores. These values are the pooled data for all 37 participants, 19 receiving one sequence and 18 the other sequence.|"For the wear-time crossover field trial, the APHAB was measured following both the audiology best-practices hearing aid fitting (PRO-FIT) and the self-fitting method (SELF-FIT).~* Null hypothesis: Mean (APHAB SELF-FIT - APHAB PRO-FIT ) ≥ 8.4~* Alternative hypothesis: Mean (APHAB SELF-FIT - APHAB PRO-FIT) \< 8.4~The mean difference between the aided scores for the two fitting methods, Self-Fit minus Pro-Fit, represent the primary outcome measure. The expected difference = 0."||4.73|-1.59|<0.025
71010694|NCT04823494|141528344|NON_INFERIORITY|For the QuickSIN, a clinically meaningful difference is 3 dB and half that difference resulted in a margin of 1.5 dB. This 1.5-dB margin was used for the QuickSIN for the non-inferiority analyses of the data from the field-trial component. The mean difference, QuickSIN Self-Fit minus QuickSIN Pro-Fit, should be less than 1.5 dB for the entire sample (N=37) to meet the non-inferiority criterion.|Mean Difference (Final Values)|0.58|||<|0.025|TWO_SIDED|95.0|-0.03|1.2||The a priori threshold value of 0.05 was Bonferroni-adjusted to 0.025 based on the use of two outcome measures, APHAB global (primary) and QuickSIN (secondary).|t-test, 1 sided|The mean differences in dB, SELF-FIT minus PRO-FIT, were calculated with 95% confidence intervals (bias-corrected, accelerated bootstrap) generated.|Mean differences in aided QuickSIN SNR in dB, Self-Fit minus Pro-Fit, were calculated for the entire group of 37 participants with about 1/2 receiving one of the two fit sequences (Pro-Fit then Self-Fit or Self-Fit then Pro-Fit).|"For the QuickSIN, aided performance after each wear period was compared between SELF-FIT and PRO-FIT.~* Null hypothesis: Mean (QuickSIN SELF-FIT - QuickSIPRO-FIT) ≥ 1.5 dB~* Alternative hypothesis: Mean (QuickSIN SELF-FIT - QuickSIN PRO-FIT) \< 1.5 dB~Power calculations were based on the primary outcome measured, the aided APHAB global score, (see information for that outcome measure). With the minimum required N of 32 based on the APHAB global score, the power for QuickSIN exceeded 80%."||1.20|-0.03|<0.025
71010695|NCT00784225|141528369|SUPERIORITY||Cox Proportional Hazard|0.75||||0.52|TWO_SIDED|95.0|0.32|1.79|||Regression, Cox|||Statistical analysis for number of participants with visually significant AMD in SEE sites during pill-taking for selenium||1.79|0.32|0.52
71010696|NCT00784225|141528369|SUPERIORITY||Cox Proportional Hazard|0.75||||0.51|TWO_SIDED|95.0|0.31|1.77|||Regression, Cox|||Statistical analysis for number of participants with visually significant AMD in SEE sites during pill-taking for vitamin E||1.77|0.31|0.51
71010697|NCT00784225|141528370|SUPERIORITY||Cox Proportional Hazard|0.91||||0.37|TWO_SIDED|95.0|0.75|1.11|||Regression, Cox|||||1.11|0.75|0.37
71010698|NCT00784225|141528370|SUPERIORITY||Cox Proportional Hazard|1.02||||0.81|TWO_SIDED|95.0|0.84|1.25|||Regression, Cox|||||1.25|0.84|0.81
71010699|NCT00784225|141528371|SUPERIORITY||Cox Proportional Hazard|2.5||||0.12|TWO_SIDED|95.0|0.79|7.98|||Regression, Cox|||Statistical analysis for number of participants with advanced AMD in SEE sites during pill-taking for selenium||7.98|0.79|0.12
71010700|NCT00784225|141528371|SUPERIORITY||Cox Proportional Hazard|0.99||||0.98|TWO_SIDED|95.0|0.35|2.82|||Regression, Cox|||Statistical analysis for number of participants with advanced AMD in SEE sites during pill-taking for vitamin E||2.82|0.35|0.98
71010701|NCT00784225|141528372|SUPERIORITY||Cox Proportional Hazard|0.84||||0.19|TWO_SIDED|95.0|0.64|1.09|||Regression, Cox|||||1.09|0.64|0.19
71010702|NCT00784225|141528372|SUPERIORITY||Cox Proportional Hazard|1.08||||0.58|TWO_SIDED|95.0|0.83|1.41|||Regression, Cox|||||1.41|0.83|0.58
71010703|NCT00313716|141528373|SUPERIORITY_OR_OTHER|||||||0.01||||||"H0: Proportion of participants expected to have a favorable GOS outcome in the Epo2 group - in Placebo group is \>= 0.2.~H1: Proportion in Epo2 group - in Placebo group \< 0.2"|Futility analysis|||The primary analysis plan was a futility trial of the Epo 2 regimen arm. We hypothesized that 30% of subjects in the placebo group would have a favorable outcome at six months and there would be no interaction between the Epo and the transfusion threshold groups. Using a one-sided alpha of 0.15, a sample size of 62 subjects in the Epo 2 regimen group and 100 subjects in the placebo group provided 91% power to test the futility hypothesis.||||.01
71010704|NCT00313716|141528373|SUPERIORITY_OR_OTHER|||||||0.13||||||"H0: Proportion of participants expected to have a favorable GOS outcome in the Epo1 group - in Placebo group is \>= 0.2.~H1: Proportion in Epo1 group - in Placebo group \< 0.2"|Futility analysis|||The primary analysis plan was a futility trial of the Epo 1 regimen arm. We hypothesized that 30% of subjects in the placebo group would have a favorable outcome at six months and there would be no interaction between the Epo and the transfusion threshold groups.||||0.13
71010705|NCT00313716|141528373|SUPERIORITY_OR_OTHER|||||||0.34|||||||2-sample test of proportions|||We hypothesized that 40% of the patients in the TT7 group would have a favorable GOS score and that there would be no interaction between the Epo and TT groups. Assuming a 2-sided test with an alpha level of 0.05, we estimated that a sample size of 200 patients would provide 80% power to detect a 20% absolute increase in the GOS score for the TT10 group.||||.34
71010706|NCT00313716|141528374|SUPERIORITY_OR_OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||.06
71010707|NCT00313716|141528375|SUPERIORITY_OR_OTHER|||||||0.25|||||||Log Rank|||||||.25
71010708|NCT00313716|141528375|SUPERIORITY_OR_OTHER|||||||0.75|||||||Log Rank|||||||.75
71010709|NCT00313716|141528375|SUPERIORITY_OR_OTHER|||||||0.72|||||||Log Rank|||||||.72
71010710|NCT00313716|141528376|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.79||||0.08|TWO_SIDED|95.0|0.93|3.45|||Regression, Cox|||||3.45|.93|.08
71010711|NCT00313716|141528377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.26|TWO_SIDED|95.0|-0.22|0.05|||2-sample test - equality of proportions|||||.05|-.22|.26
71010712|NCT01347931|141528390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|STANDARD_DEVIATION|7.0|<|0.05|TWO_SIDED|95.0|2.0|10.0|||t-test, 2 sided|||A sample size of 26 patient pairs was determined based on the assumption of a true treatment difference in mean ADL endurance time of 4 ± 7 minutes using a two-tailed, paired t test (α=0.05, power=0.80).||10|2|<0.05
71010713|NCT01347931|141528391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|4.0|<|0.05|TWO_SIDED|95.0|1.0|7.0|||t-test, 2 sided|||Two-tailed t test||7|1|<0.05
71010714|NCT02528643|141528395|SUPERIORITY||Hazard Ratio (HR)|1.146||||0.248|TWO_SIDED|95.0|0.774|1.696||One-sided p-value.|Log Rank||Calculated using a Cox proportional hazard model, stratified by geographic region and ECOG performance status. Hazard ratio \< 1 indicated a reduction in hazard rate in favor of enzalutamide group.|Stratified Analysis. The null hypothesis was stated as: OS distributions of the 2 arms are equivalent. The alternative hypothesis was stated as: OS is prolonged in enzalutamide arm. The null hypothesis was tested using a stratified one-sided log-rank test at the 0.10 level. Stratification factors were ECOG performance status and region from eCRF.||1.696|0.774|0.248
71010715|NCT02528643|141528395|SUPERIORITY||Hazard Ratio (HR)|1.142||||0.252|TWO_SIDED|95.0|0.773|1.688||One-sided p-value.|Log Rank||Calculated using a Cox proportional hazard model. Hazard ratio \< 1 indicated a reduction in hazard rate in favor of enzalutamide group.|Unstratified Analysis. The null hypothesis was stated as: OS distributions of the 2 arms are equivalent. The alternative hypothesis was stated as: OS is prolonged in enzalutamide arm. The null hypothesis was tested using a one-sided log-rank test at the 0.10 level.||1.688|0.773|0.252
71010716|NCT02528643|141528400|SUPERIORITY||Hazard Ratio (HR)|1.039||||0.396|TWO_SIDED|95.0|0.732|1.474||One-sided p-value.|Log Rank||Calculated using a Cox proportional hazard model, stratified by ECOG performance status and region. Hazard ratio \< 1 indicated a reduction in hazard rate in favor of enzalutamide group.|Stratified Analysis. The null hypothesis was stated as: PFS distributions of the 2 arms are equivalent. The alternative hypothesis was stated as: PFS is prolonged in enzalutamide arm. The null hypothesis was tested using a stratified one-sided log-rank test at the 0.10 level. Stratification factors were ECOG performance status and region from eCRF.||1.474|0.732|0.396
71010717|NCT02528643|141528400|SUPERIORITY||Hazard Ratio (HR)|0.959||||0.586|TWO_SIDED|95.0|0.684|1.345||One-sided p-value.|Log Rank||Calculated using a Cox proportional hazard model. Hazard ratio \< 1 indicated a reduction in hazard rate in favor of enzalutamide group.|Unstratified Analysis. The null hypothesis was stated as: PFS distributions of the 2 arms are equivalent. The alternative hypothesis was stated as: PFS is prolonged in enzalutamide arm. The null hypothesis was tested using a one-sided log-rank test at the 0.10 level.||1.345|0.684|0.586
71010718|NCT04120116|141528401|SUPERIORITY||Odds Ratio (OR)|0.3||||0.068|TWO_SIDED|95.0|0.11|1.08||P value for statistical significance is \<0.05|Mixed Models Analysis|||||1.08|0.11|0.068
71010719|NCT04120116|141528403|SUPERIORITY||Least squares mean difference|1.25|STANDARD_ERROR_OF_MEAN|2.611||0.634|TWO_SIDED|95.0|-3.945|6.439||P value for statistical significance is \<0.05|Mixed Models Analysis|||||6.439|-3.945|0.634
71010720|NCT02087085|141528407|SUPERIORITY||Least Squares Mean Difference|-0.3589|STANDARD_ERROR_OF_MEAN|0.1804||0.047|TWO_SIDED|95.0|-0.7132|-0.0047||MMRM model included treatment group, study region, analysis visit and treatment-by-visit interaction as factors and baseline value and baseline value-by-analysis visit interaction as covariates.|MMRM|||||-0.0047|-0.7132|0.047
71010721|NCT02087085|141528408|SUPERIORITY||Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|1.4||0.39|TWO_SIDED|95.0|-3.9|1.5||MMRM model included treatment group, study region, analysis visit and treatment-by-visit interaction as factors and baseline value and baseline value-by-analysis visit interaction as covariates.|MMRM|||||1.5|-3.9|0.390
71010722|NCT02087085|141528409|SUPERIORITY||Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|1.4||0.301|TWO_SIDED|95.0|-4.2|1.3||MMRM model included treatment group, study region, analysis visit and treatment-by-visit interaction as factors and baseline value and baseline value-by-analysis visit interaction as covariates.|MMRM|||||1.3|-4.2|0.301
71010723|NCT00883896|141528434|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-5.9||||0.558|TWO_SIDED|95.0|-25.0|13.3|||Cochran-Mantel-Haenszel|||P-value was assessed from 2-sided Cochran-Mantel-Haenszel (CMH) test stratified by anti-tumor necrosis factor (anti-TNF) prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||13.3|-25.0|0.558
71010724|NCT00883896|141528434|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-11.4||||0.251|TWO_SIDED|95.0|-30.1|7.3|||Cochran-Mantel-Haenszel|||P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||7.3|-30.1|0.251
71010725|NCT00883896|141528434|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-3.7||||0.707|TWO_SIDED|95.0|-21.7|14.4|||Cochran-Mantel-Haenszel|||P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||14.4|-21.7|0.707
71010726|NCT00883896|141528435|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-0.1||||0.991|TWO_SIDED|95.0|-14.8|14.7|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||14.7|-14.8|0.991
71010727|NCT00883896|141528435|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-4.8||||0.518|TWO_SIDED|95.0|-18.4|8.8|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||8.8|-18.4|0.518
71010728|NCT00883896|141528435|SUPERIORITY_OR_OTHER_LEGACY||Perecent Difference|0.781||||0.63|TWO_SIDED|95.0|-16.9|9.8|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||9.8|-16.9|0.630
71046743|NCT00380692|141602141|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-80.9|STANDARD_ERROR_OF_MEAN|77.5||0.299||95.0|-234.3|72.5||P-value for Treatment\*Condition Standard Deviation correct rejections irrelevant target over time.|Mixed Models Analysis|||||72.5|-234.3|0.299
71046744|NCT00380692|141602141|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.6|STANDARD_ERROR_OF_MEAN|67.1||0.84||95.0|-119.3|146.5||P-value for Treatment\*Condition Standard Deviation correct rejections relevant nontarget over time.|Mixed Models Analysis|||||146.5|-119.3|0.840
71046745|NCT00380692|141602142|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.3|STANDARD_ERROR_OF_MEAN|2.8||0.126||95.0|-1.2|9.9||P-value for Treatment differences in Error Rate over time.|Mixed Models Analysis|||||9.9|-1.2|0.126
71046746|NCT00380692|141602142|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|1.7||0.297||95.0|-5.2|1.6||P-value for Treatment\*Error Rate absent over time.|Mixed Models Analysis|||||1.6|-5.2|0.297
71046747|NCT00380692|141602142|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.1|STANDARD_ERROR_OF_MEAN|2.1||0.023||95.0|-9.4|-0.7||P-value for Treatment\*Targets Load 1 over time.|Mixed Models Analysis|||||-0.7|-9.4|0.023
71046748|NCT00380692|141602143|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-87.2|STANDARD_ERROR_OF_MEAN|71.7||0.228||95.0|-230.4|56.0||P-value for Treatment differences in Reaction Time over time.|Mixed Models Analysis|||||56.0|-230.4|0.228
71046749|NCT00380692|141602143|SUPERIORITY_OR_OTHER||Mean Difference (Net)|87.6|STANDARD_ERROR_OF_MEAN|77.3||0.26||95.0|-65.6|240.8||P-value for Treatment\*Condition Mean Reaction Time correct rejections Load 1 over time.|Mixed Models Analysis|||||240.8|-65.6|0.260
71046750|NCT00380692|141602143|SUPERIORITY_OR_OTHER||Mean Difference (Net)|70.4|STANDARD_ERROR_OF_MEAN|59.5||0.239||95.0|-47.3|188.2||P-value for Treatment\*Condition Mean Reaction Time correct rejections Load 2 over time.|Mixed Models Analysis|||||188.2|-47.3|0.239
71046751|NCT00380692|141602143|SUPERIORITY_OR_OTHER||Mean Difference (Net)|122.7|STANDARD_ERROR_OF_MEAN|80.1||0.128||95.0|-35.9|281.4||P-value for Treatment\*Condition Mean Reaction Time hits Load 1 over time.|Mixed Models Analysis|||||281.4|-35.9|0.128
71046752|NCT00380692|141602144|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-175.5|STANDARD_ERROR_OF_MEAN|88.0||0.051||95.0|-351.5|0.5||P-value for Treatment differences in Standard Deviation of Reaction Time over time.|Mixed Models Analysis|||||0.5|-351.5|0.051
71046753|NCT00380692|141602144|SUPERIORITY_OR_OTHER||Mean Difference (Net)|218.1|STANDARD_ERROR_OF_MEAN|90.8||0.018||95.0|38.0|398.2||P-value for Treatment\*Condition Standard Deviation correct rejections Load 1 over time.|Mixed Models Analysis|||||398.2|38.0|0.018
71046754|NCT00380692|141602144|SUPERIORITY_OR_OTHER||Mean Difference (Net)|173.6|STANDARD_ERROR_OF_MEAN|105.6||0.103||95.0|-35.7|383.0||P-value for Treatment\*Condition Standard Deviation correct rejections Load 2 over time.|Mixed Models Analysis|||||383.0|-35.7|0.103
71046755|NCT00380692|141602144|SUPERIORITY_OR_OTHER||Mean Difference (Net)|205.5|STANDARD_ERROR_OF_MEAN|99.9||0.042||95.0|7.5|403.6||P-value for Treatment\*Condition Standard Deviation hits Load 1 over time.|Mixed Models Analysis|||||403.6|7.5|0.042
71046756|NCT00380692|141602145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.3|STANDARD_ERROR_OF_MEAN|4.6||0.128||95.0|-16.9|2.3||P-value for Treatment difference in Accuracy over time.|Mixed Models Analysis|||||2.3|-16.9|0.128
71046757|NCT00380692|141602146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.1|STANDARD_ERROR_OF_MEAN|2.4||0.022||95.0|-11.2|-1.0||P-value for Treatment difference in Stability of Movement over time.|Mixed Models Analysis|||||-1.0|-11.2|0.022
71046758|NCT00380692|141602147|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|2.0||0.43||95.0|-2.4|5.7||P-value for Treatment difference in Error Rate over time.|Mixed Models Analysis|||||5.7|-2.4|0.430
71046759|NCT00380692|141602147|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.0|STANDARD_ERROR_OF_MEAN|2.4||0.005||95.0|-11.8|-2.2||P-value for Treatment\*Condition Error Rate irrelevant targets over time.|Mixed Models Analysis|||||-2.2|-11.8|0.005
71046760|NCT00380692|141602148|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.6|STANDARD_ERROR_OF_MEAN|2.9||0.221||95.0|-9.6|2.3||P-value for Treatment differences in Error Rates over time.|Mixed Models Analysis|||||2.3|-9.6|0.221
71046761|NCT00380692|141602148|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.1|STANDARD_ERROR_OF_MEAN|2.0||0.307||95.0|-2.1|6.3||P-value for Treatment\*Condition Error Rates compatible signals over time.|Mixed Models Analysis|||||6.3|-2.1|0.307
71046762|NCT00380692|141602149|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.0|STANDARD_ERROR_OF_MEAN|68.9||0.752||95.0|-163.1|119.1||P-value for Treatment differences in Reaction Time over time.|Mixed Models Analysis|||||119.1|-163.1|0.752
71046763|NCT00380692|141602149|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.6|STANDARD_ERROR_OF_MEAN|31.9||0.564||95.0|-47.0|84.3||P-value for Treatment\*Condition Mean Reaction Time correct rejections Load 2 over time.|Mixed Models Analysis|||||84.3|-47.0|0.564
71046764|NCT01388166|141602151|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71046765|NCT01388166|141602152|SUPERIORITY_OR_OTHER|||||||0.0002|||||||t-test, 2 sided|||||||0.0002
71046766|NCT01388166|141602153|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71046767|NCT01429051|141602172|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1||||0.002|TWO_SIDED|95.0|0.41|1.179|||Mixed Models Analysis|A mixed effects model with episode baseline PI as a covariate, treatment as a fixed effect and patient as a random effect.||||1.179|0.41|0.002
71046768|NCT01939496|141602193|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-3.29|STANDARD_ERROR_OF_MEAN|1.748||0.062|TWO_SIDED|95.0|-6.743|0.163|||ANCOVA|||||0.163|-6.743|0.062
71046769|NCT01939496|141602193|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-4.93|STANDARD_ERROR_OF_MEAN|1.75||0.006|TWO_SIDED|95.0|-8.382|-1.469|||ANCOVA|||||-1.469|-8.382|0.006
71046770|NCT02011113|141602252|SUPERIORITY_OR_OTHER|||||||0.0027||||||Based on one sample binomial test for dichotomized response proportion against the null hypothesis(H0: p = 0.1)|Binomial test for dichotomized response|||||||0.0027
71010729|NCT00883896|141528435|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|9.4||||0.295|TWO_SIDED|95.0|-8.3|27.0|||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||27.0|-8.3|0.295
71010730|NCT00883896|141528435|SUPERIORITY_OR_OTHER_LEGACY||Perecent Difference|-3.4||||0.686|TWO_SIDED|95.0|-19.3|12.5|||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||12.5|-19.3|0.686
71010731|NCT00883896|141528435|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.5||||0.772|TWO_SIDED|95.0|-13.2|18.2|||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||18.2|-13.2|0.772
71010732|NCT00883896|141528435|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|12.8||||0.201|TWO_SIDED|95.0|-6.5|32.0|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||32.0|-6.5|0.201
71010733|NCT00883896|141528435|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-10.4||||0.256|TWO_SIDED|95.0|-27.3|6.5|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||6.5|-27.3|0.256
71010734|NCT00883896|141528435|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|6.1||||0.519|TWO_SIDED|95.0|-11.4|23.5|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||23.5|-11.4|0.519
71010735|NCT00883896|141528435|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|16.7||||0.094|TWO_SIDED|95.0|-1.9|35.2|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||35.2|-1.9|0.094
71010736|NCT00883896|141528435|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.8||||0.76|TWO_SIDED|95.0|-14.4|20.1|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||20.1|-14.4|0.760
71010737|NCT00883896|141528435|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.6||||0.95|TWO_SIDED|95.0|-16.8|18.0|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||18.0|-16.8|0.950
71010738|NCT00883896|141528435|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|13.6||||0.185|TWO_SIDED|95.0|-5.9|33.0|||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||33.0|-5.9|0.185
71010739|NCT00883896|141528435|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.2||||0.982|TWO_SIDED|95.0|-18.8|19.3|||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||19.3|-18.8|0.982
71010740|NCT00883896|141528435|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-11.6||||0.223|TWO_SIDED|95.0|-29.0|5.8|||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||5.8|-29.0|0.223
71010741|NCT00883896|141528436|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-0.5||||0.885|TWO_SIDED|95.0|-6.8|5.8|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||5.8|-6.8|0.885
71010742|NCT00883896|141528436|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|6.1||||0.18|TWO_SIDED|95.0|-3.4|15.6|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||15.6|-3.4|0.180
71010743|NCT00883896|141528436|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-2.7||||0.277|TWO_SIDED|95.0|-6.5|1.1|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||1.1|-6.5|0.277
71046771|NCT00468728|141602272|NON_INFERIORITY_OR_EQUIVALENCE|The point estimate of the difference and the 2-sided 95% confidence interval (CI) for the difference between treatment groups were computed. If the lower limit of the CI was greater than -10%, the clinical non-inferiority of fidaxomicin was demonstrated. CIs for the difference of cure rates were calculated using the method recommended by Agresti and Caffo.|Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-4.8|6.8||||||H0: C(OPT-80) - C(VAN) \<= -10% Power calculation is based on cure rate of 85% in both treatment groups, non-inferiority margin of 10%, 2.5% (1-sided) type I error rate with approximately 90% power gives a total of 530 subjects.||6.8|-4.8|
70928614|NCT04800211|141353079|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|0.466||||0.0012|TWO_SIDED|95.0|0.185|0.747|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||0.747|0.185|0.0012
70928615|NCT04800211|141353079|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.099||||0.4957|TWO_SIDED|95.0|-0.187|0.386|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||0.386|-0.187|0.4957
71010744|NCT00883896|141528436|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|1.7||||0.74|TWO_SIDED|95.0|-7.9|11.3|||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||11.3|-7.9|0.740
71010745|NCT00883896|141528436|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.4||||0.934|TWO_SIDED|95.0|-9.3|10.1|||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||10.1|-9.3|0.934
71010746|NCT00883896|141528436|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-0.6||||0.876|TWO_SIDED|95.0|-7.7|6.4|||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||6.4|-7.7|0.876
71010747|NCT00883896|141528436|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-1.1||||0.842|TWO_SIDED|95.0|-11.4|9.2|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||9.2|-11.4|0.842
71010748|NCT00883896|141528436|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|4.1||||0.509|TWO_SIDED|95.0|-8.1|16.3|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||16.3|-8.1|0.509
71010749|NCT00883896|141528436|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|4.0||||0.504|TWO_SIDED|95.0|-7.0|15.0|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||15.0|-7.0|0.504
71010750|NCT00883896|141528436|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|5.4||||0.373|TWO_SIDED|95.0|-6.3|17.0|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||17.0|-6.3|0.373
71010751|NCT00883896|141528436|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-3.4||||0.499|TWO_SIDED|95.0|-12.0|5.2|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||5.2|-12.0|0.499
71103758|NCT00721110|141715019|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.6||||0.2|TWO_SIDED|97.5|-0.9|2.2||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Lidocaine versus nonlidocaine on postoperative day 1 pain severity assessed using a t test.||2.2|-0.9|0.20
71010752|NCT00883896|141528436|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|7.0||||0.244|TWO_SIDED|95.0|-4.2|18.3|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||18.3|-4.2|0.244
71010753|NCT00883896|141528436|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-0.2||||0.979|TWO_SIDED|95.0|-15.0|14.6|||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||14.6|-15.0|0.979
71010754|NCT00883896|141528436|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-9.8||||0.166|TWO_SIDED|95.0|-21.8|2.2|||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||2.2|-21.8|0.166
71103759|NCT00721110|141715019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.79|TWO_SIDED|97.5|-1.4|1.7||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Ketamine versus nonketamine on postoperative day 1 pain severity was assessed using a t test.||1.7|-1.4|0.79
71010755|NCT00883896|141528436|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.5||||0.947|TWO_SIDED|95.0|-13.2|14.2|||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||14.2|-13.2|0.947
71010756|NCT00883896|141528436|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|8.3||||0.286|TWO_SIDED|95.0|-7.1|23.8|||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||23.8|-7.1|0.286
71010757|NCT00883896|141528436|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-1.6||||0.822|TWO_SIDED|95.0|-15.0|11.8|||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||11.8|-15.0|0.822
71010758|NCT00883896|141528436|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-0.1||||0.986|TWO_SIDED|95.0|-12.3|12.1|||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||12.1|-12.3|0.986
71010759|NCT00883896|141528437|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.5||||0.205|TWO_SIDED|95.0|-2.3|7.4|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||7.4|-2.3|0.205
71010760|NCT00883896|141528437|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.5||||0.188|TWO_SIDED|95.0|-2.3|7.3|||Cochran-Mantel-Haenszel|||Week 2:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||7.3|-2.3|0.188
71010761|NCT00883896|141528437|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Week 2: Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||0.0|0.0|
71010762|NCT00883896|141528437|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|1.1||||0.699|TWO_SIDED|95.0|-4.5|6.6|||Cochran-Mantel-Haenszel|||Week 4:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||6.6|-4.5|0.699
71010763|NCT00883896|141528437|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|5.4||||0.155|TWO_SIDED|95.0|-3.0|13.8|||Cochran-Mantel-Haenszel|||Week 4:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||13.8|-3.0|0.155
71010764|NCT00883896|141528437|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-1.0||||0.546|TWO_SIDED|95.0|-2.9|0.9|||Cochran-Mantel-Haenszel|||Week 4:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||0.9|-2.9|0.546
71010765|NCT00883896|141528437|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.5||||0.205|TWO_SIDED|95.0|-2.3|7.4|||Cochran-Mantel-Haenszel|||Week 6:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||7.4|-2.3|0.205
71010766|NCT00883896|141528437|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.2||||0.269|TWO_SIDED|95.0|-1.8|6.1|||Cochran-Mantel-Haenszel|||Week 6:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||6.1|-1.8|0.269
71010767|NCT00883896|141528437|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.0||||0.723|TWO_SIDED|95.0|-1.6|5.6|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||5.6|-1.6|0.723
71010768|NCT00883896|141528437|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.5||||0.205|TWO_SIDED|95.0|-2.3|7.4|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||7.4|-2.3|0.205
71010769|NCT00883896|141528437|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Week 8: Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the cochran method.||0.0|0.0|
71010770|NCT00883896|141528437|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|4.0||||0.125|TWO_SIDED|95.0|-1.3|9.4|||Cochran-Mantel-Haenszel|||Week 8:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||9.4|-1.3|0.125
71010771|NCT00883896|141528437|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|5.0||||0.071|TWO_SIDED|95.0|-1.7|11.8|||Cochran-Mantel-Haenszel|||Week 10:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||11.8|-1.7|0.071
71046772|NCT00468728|141602273|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-14.4|||<|0.001|TWO_SIDED|95.0|-21.6|-7.0|||Chi-squared|||||-7.0|-21.6|<0.001
71010772|NCT00883896|141528437|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.0||||0.317|TWO_SIDED|95.0|-1.2|5.1|||Cochran-Mantel-Haenszel|||Week 10:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||5.1|-1.2|0.317
71010773|NCT00883896|141528437|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.0||||0.28|TWO_SIDED|95.0|-1.6|5.6|||Cochran-Mantel-Haenszel|||Week 10:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||5.6|-1.6|0.280
71010774|NCT00883896|141528437|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.6||||0.892|TWO_SIDED|95.0|-7.6|8.8|||Cochran-Mantel-Haenszel|||Week 12:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||8.8|-7.6|0.892
71010775|NCT00883896|141528437|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-0.5||||0.903|TWO_SIDED|95.0|-8.3|7.2|||Cochran-Mantel-Haenszel|||Week 12:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||7.2|-8.3|0.903
71010776|NCT00883896|141528437|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-1.7||||0.625|TWO_SIDED|95.0|-7.2|3.8|||Cochran-Mantel-Haenszel|||Week 12:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||3.8|-7.2|0.625
71010777|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|||||||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.900
71010778|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.522|||||||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.522
71010779|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.147|||||||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.147
71010780|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.534|||||||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.534
71010781|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.206|||||||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.206
71010782|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07|||||||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.070
71010783|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.936|||||||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.936
71010784|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.625|||||||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.625
71010785|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.586|||||||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.586
71010786|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.685|||||||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.685
71010787|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.34|||||||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.340
71010788|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.212|||||||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.212
71010789|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.455|||||||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.455
71010790|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.145|||||||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.145
71010791|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|||||||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.660
71010792|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.050
71010793|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.428|||||||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.428
71010794|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|||||||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.160
70928616|NCT04800211|141353079|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-2.753|||<|0.0001|TWO_SIDED|95.0|-3.266|-2.239|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-2.239|-3.266|<.0001
70928617|NCT04800211|141353079|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.514|||<|0.0001|TWO_SIDED|95.0|-3.043|-1.986|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-1.986|-3.043|<.0001
70928618|NCT04800211|141353079|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-2.848|||<|0.0001|TWO_SIDED|95.0|-3.359|-2.336|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-2.336|-3.359|<.0001
70928619|NCT04800211|141353079|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.586|||<|0.0001|TWO_SIDED|95.0|-3.105|-2.066|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-2.066|-3.105|<.0001
70928620|NCT04800211|141353079|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.55|||<|0.0001|TWO_SIDED|95.0|-2.901|-2.199|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-2.199|-2.901|<.0001
70928621|NCT04800211|141353079|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.071||||0.7372|TWO_SIDED|95.0|-0.346|0.489|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||0.489|-0.346|0.7372
70928622|NCT04800211|141353080|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.106|||<|0.0001|TWO_SIDED|95.0|-3.502|-2.71|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.710|-3.502|<.0001
71010795|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.757|||||||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.757
71046773|NCT00468728|141602274|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.4||||0.001||95.0|5.4|21.1|||Chi-squared|||||21.1|5.4|0.001
70928623|NCT04800211|141353080|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-2.824|||<|0.0001|TWO_SIDED|95.0|-3.235|-2.414|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.414|-3.235|<.0001
70928624|NCT04800211|141353080|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.228|||<|0.0001|TWO_SIDED|95.0|-3.553|-2.904|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.904|-3.553|<.0001
70928625|NCT04800211|141353080|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-2.839|||<|0.0001|TWO_SIDED|95.0|-3.221|-2.457|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.457|-3.221|<.0001
70928626|NCT04800211|141353080|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-2.449|||<|0.0001|TWO_SIDED|95.0|-2.828|-2.07|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.070|-2.828|<.0001
70928627|NCT04800211|141353080|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.023|||<|0.0001|TWO_SIDED|95.0|-3.328|-2.718|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.718|-3.328|<.0001
71010796|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.408|||||||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.408
71103760|NCT00721110|141715019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.55|TWO_SIDED|97.5|-1.1|1.7||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Lidocaine versus nonlidocaine on postoperative day 2 pain severity was assessed using a t test.||1.7|-1.1|0.55
71103761|NCT00721110|141715019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.47|TWO_SIDED|97.5|-1.1|1.8||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Ketamine versus nonketamine on postoperative day 2 pain severity was assessed using a t test.||1.8|-1.1|0.47
71010797|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.983|||||||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.983
71010798|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.374|||||||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.374
71010799|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.992|||||||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.992
71010800|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.422|||||||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.422
71010801|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.743|||||||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.743
71010802|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.188|||||||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.188
71010803|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.385|||||||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.385
71010804|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.148|||||||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.148
71010805|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.304|||||||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.304
71010806|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.552|||||||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.552
71010807|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.494|||||||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.494
71010808|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.421|||||||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.421
71010809|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.418|||||||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.418
71010810|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.235|||||||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.235
71010811|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.268|||||||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.268
71010812|NCT00883896|141528449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.957|||||||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.957
71010813|NCT01856920|141528450|EQUIVALENCE|Alpha= 0.05||||||0.376|||||||Rank-Sum|||||||0.3760
71010814|NCT01707667|141528457|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.8||||0.012|TWO_SIDED|95.0|1.6|9.9|||Linear Mixed-Effect Models Analysis|||||9.9|1.6|0.012
71046774|NCT01517659|141602287|OTHER||Mean Difference (Final Values)|2.61|STANDARD_DEVIATION|2.29|||TWO_SIDED|95.0|2.23|3.27||||||||3.27|2.23|
71046775|NCT02712333|141602288|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|7.53|||<|0.05|TWO_SIDED|95.0|4.65|10.41||the p-value has been adjusted for multiple comparisons|Mixed Models Analysis|||we analyzed the serum cortisol levels (presented as relative intensities in high perfomance liquid chromatography-mass spectrum) by treatments (intervention group vs control group)||10.41|4.65|<0.05
71010815|NCT01707667|141528458|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|69051.4||||0.079|TWO_SIDED|95.0|-12004.5|150107.3|||Linear Mixed-Effect Models Analysis|||||150107.3|-12004.5|0.079
71010816|NCT01707667|141528459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.2||||0.717|TWO_SIDED|95.0|-45.3|63.7|||Linear Mixed-Effect Models Analysis|||||63.7|-45.3|0.717
71010817|NCT01707667|141528460|SUPERIORITY_OR_OTHER_LEGACY|||||||0.295|TWO_SIDED||||||Log Rank|||||||0.295
71010818|NCT01707667|141528461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.179||||0.18|TWO_SIDED|95.0|-0.465|0.107|||Linear Mixed-Effect Models Analysis|||||0.107|-0.465|0.180
71010819|NCT01707667|141528462|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.8||||0.225|TWO_SIDED|95.0|-12.6|44.3|||Linear Mixed-Effect Models Analysis|||||44.3|-12.6|0.225
71010820|NCT04533204|141528513|SUPERIORITY||Mean Difference (Final Values)|18.47|||<|0.001|TWO_SIDED|95.0|12.28|24.67|||Mixed Models Analysis|||||24.67|12.28|<.001
71010821|NCT04533204|141528514|SUPERIORITY||Mean Difference (Final Values)|2.33||||0.004|TWO_SIDED|95.0|0.75|3.91||Performance on cued recall (error scores)|Mixed Models Analysis|||||3.91|.75|.004
71010822|NCT03982069|141528515|OTHER||||||<|0.001||||||All listed antigens|Chi-squared|||||||<0.001
71010823|NCT03982069|141528516|OTHER||||||<|0.001||||||All listed antigens|Chi-squared|||||||<0.001
71010824|NCT03982069|141528517|OTHER||||||<|0.001||||||Day 28 for all listed antigens|Chi-squared|||||||<0.001
71010825|NCT03982069|141528517|OTHER|||||||0.4||||||Day 0, A/H1N1-A/Brisbane|Chi-squared|||||||0.40
71010826|NCT03982069|141528517|OTHER|||||||0.36||||||Day 0 A/H1N1-A/Kansas egg grown virus|Chi-squared|||||||0.36
71010827|NCT03982069|141528517|OTHER|||||||0.08||||||Day 0 A/H1N1-A/Kansas cell grown virus|Chi-squared|||||||0.08
71010828|NCT03982069|141528517|OTHER|||||||0.91||||||Day 0 B/Victoria-B/Colorado|Chi-squared|||||||0.91
71010829|NCT03982069|141528517|OTHER|||||||0.31||||||Day 0 B/Yamagata-B/Phuket|Chi-squared|||||||0.31
71010830|NCT03982069|141528518|OTHER|||||||0.79||||||Day 0 A/H1N1-A/Brisbane|t-test, 2 sided|||||||0.79
71046776|NCT02712333|141602288|SUPERIORITY_OR_OTHER||fold change|1.33|||<|0.01|TWO_SIDED||||||t-test, 2 sided||fold change is calculated by measurments from the sham purification group/measurements from the real purification group|||||<0.01
71010831|NCT03982069|141528518|OTHER|||||||0.79||||||Day 0 A/H3N2-A/Kansas egg grown virus|t-test, 2 sided|||||||0.79
70928628|NCT04800211|141353080|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.126|||<|0.0001|TWO_SIDED|95.0|-3.354|-2.897|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.897|-3.354|<.0001
70928629|NCT04800211|141353080|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|0.908|||<|0.0001|TWO_SIDED|95.0|0.518|1.298|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||1.298|0.518|<.0001
70928630|NCT04800211|141353080|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|1.291|||<|0.0001|TWO_SIDED|95.0|0.902|1.679|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||1.679|0.902|<.0001
70941362|NCT02799745|141383291|SUPERIORITY||LS mean difference|-5.15|STANDARD_ERROR_OF_MEAN|3.174||0.1063|TWO_SIDED|95.0|-11.4|1.11||P-values: from differences of least squares means.Bonferroni-Holm was used in the primary hypothesis testing to adjust for multiplicity.|Mixed Models Analysis|Compound symmetry was used as the covariance structure. Covariance parameters:estimated using Restricted Maximum likelihood.|MMRM with treatment group, prostate cancer risk (low vs. intermediate), type of biopsy (mpMRI targeted vs. non mpMRI targeted), visit, visit-by-treatment and baseline scores were the fixed factors, and site and participants were the random factors.|Change at month 24||1.11|-11.40|0.1063
71010832|NCT03982069|141528518|OTHER|||||||0.56||||||Day 0 A/H3N2-A/Kansas cell grown virus|t-test, 2 sided|||||||0.56
71010833|NCT03982069|141528518|OTHER|||||||0.95||||||Day 0 B/Victoria-B/Colorado|t-test, 2 sided|||||||0.95
71010834|NCT03982069|141528518|OTHER|||||||0.44||||||Day 0 B/Yamagata-B/Phuket|t-test, 2 sided|||||||0.44
71010835|NCT03982069|141528518|OTHER||||||<|0.001||||||Day 28 for all listed variables|t-test, 2 sided|||||||<0.001
71010836|NCT03982069|141528519|OTHER|||||||0.83|||||||Chi-squared|Day 0: A/H1N1-A/Hawaii66-egg based antigen||||||0.83
71010837|NCT03982069|141528519|OTHER|||||||0.79|||||||Chi-squared|Day 0: A/H1N1-A/Hawaii70-cell based antigen||||||0.79
71010838|NCT03982069|141528519|OTHER|||||||0.65|||||||Chi-squared|Day 0: A/H1N1-A/Delaware||||||0.65
71010839|NCT03982069|141528519|OTHER|||||||0.06|||||||Chi-squared|Day 0: A/H3N2-A/Hong Kong||||||0.06
71010840|NCT03982069|141528519|OTHER|||||||0.98|||||||Chi-squared|Day 0: B/Victoria-B/Washington||||||0.98
71010841|NCT03982069|141528519|OTHER|||||||0.24|||||||Chi-squared|Day 0: B/Yamagata-B/Phuket||||||0.24
71010842|NCT03982069|141528519|OTHER||||||<|0.01|||||||Chi-squared|Day 28: A/H1N1-A/Hawaii66-egg based antigen, A/H1N1-A/Hawaii70-cell based antigen, A/H1N1-A/Delaware, B/Victoria-B/Washington, B/Yamagata-B/Phuket||||||<0.01
71010843|NCT03982069|141528519|OTHER|||||||0.66|||||||Chi-squared|A/H3N2-A/Hong Kong||||||0.66
71010844|NCT03982069|141528520|OTHER|||||||0.22||||||Day 0: A/H1N1-A/Hawaii66 egg based antigen|t-test, 2 sided|||||||0.22
71010845|NCT03982069|141528520|OTHER|||||||0.25||||||Day 0: A/H1N1-A/Hawaii70 cell based antigen|t-test, 2 sided|||||||0.25
71010846|NCT03982069|141528520|OTHER|||||||0.13||||||Day 0: A/H1N1-A/Delaware|t-test, 2 sided|||||||0.13
71010847|NCT03982069|141528520|OTHER|||||||0.06||||||Day 0: A/H3N2-A/Hong Kong|t-test, 2 sided|||||||0.06
71010848|NCT03982069|141528520|OTHER|||||||0.78||||||Day 0: B/Victoria-B/Washington|t-test, 2 sided|||||||0.78
71010849|NCT03982069|141528520|OTHER|||||||0.36||||||Day 0: B/Yamagata-B/Phuket|t-test, 2 sided|||||||0.36
71010850|NCT03982069|141528520|OTHER||||||<|0.0001||||||Day 28: A/H1N1-A/Hawaii66 egg based antigen, A/H1N1-A/Hawaii70 cell based antigen, A/H1N1-A/Delaware, B/Victoria-B/Washington, B/Yamagata-B/Phuket|t-test, 2 sided|||||||<0.0001
71010851|NCT03982069|141528520|OTHER|||||||0.01||||||Day 28: A/H3N2-A/Hong Kong|t-test, 2 sided|||||||0.01
71010852|NCT03547960|141528563|SUPERIORITY|||||||0.639|||||||Chi-squared|||||||0.639
71010853|NCT03547960|141528563|SUPERIORITY|||||||0.283|||||||Wilcoxon (Mann-Whitney)|||||||0.283
71010854|NCT03547960|141528565|SUPERIORITY|||||||0.564|||||||Wilcoxon (Mann-Whitney)|||||||0.564
71010855|NCT03503617|141528580|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
71010856|NCT02452892|141528588|SUPERIORITY|To control for multiple comparisons in the primary endpoint analysis, a hierarchical approach was taken. First LFMS 60min. was compared to LFMS sham. If p\<0.05 for this comparison, then LFMS 20min. was formally compared to LFMS sham for statistical significance.||||||0.307||||||"P-value displayed for 60min.~Mixed Model Repeated Measures (MMRM) model."|Mixed Models Analysis|Week 1 baseline HAM-D6 total score, treatment,visit treatment\*visit age, \& gender included in model. Visit was the repeated measure within subjects.||Comparisons of 60 min LFMS vs. sham, LSMean diff with 95% Confidence Interval (CI) reported. Hypothesis 1: no difference between 60 min. LFMS and sham therapy in mean change from baseline (Day 1) to end of Tx Day 4 in HAM-D6 total score. If hypothesis is rejected at significance level of 0.05, then second hypothesis will be tested. Hypothesis 2:no difference between 20 min. LFMS \& sham therapy in mean change from baseline (Day 1) to the end of Tx. Day 4 in HAM-D6 total score.||||0.307
71010857|NCT02452892|141528588|SUPERIORITY|To control for multiple comparisons in the primary endpoint analysis, a hierarchical approach was taken. First LFMS 60min. was compared to LFMS sham. If p\<0.05 for this comparison, then LFMS 20min. was formally compared to LFMS sham for statistical significance.||||||0.859||||||P-value displayed for 20min. Mixed Model Repeated Measures (MMRM) model.|Mixed Models Analysis|Week 1 baseline HAM-D6 total score, treatment,visit treatment\*visit age, \& gender included in model. Visit was the repeated measure within subjects.||Comparisons of 20 min LFMS vs. sham, LSMean diff with 95% Confidence Interval (CI) reported. Hypothesis 1: no difference between 60 min. LFMS and sham therapy in mean change from baseline (Day 1) to end of Tx Day 4 in HAM-D6 total score. If hypothesis is rejected at significance level of 0.05, then second hypothesis will be tested. Hypothesis 2:no difference between 20 min. LFMS \& sham therapy in mean change from baseline (Day 1) to the end of Tx. Day 4 in HAM-D6 total score.||||0.859
71010858|NCT02452892|141528589|SUPERIORITY|||||||0.966||||||P-value is not adjusted for multiple comparisons. P-value was estimated from Mixed Model Repeated Measures (MMRM) model.|Mixed Models Analysis|Week 2 baseline HAM-D6 total score, treatment, visit, treatment\*visit, age, \& gender included in model. Visit was the repeated measure within subject.||||||0.966
71010859|NCT02452892|141528590|SUPERIORITY|The persistence rate calculated based on Week 1 treatment group: 20 minutes LFMS, 60 minutes LFMS and sham therapy.||||||0.294||||||For 60 min LFMS, P-value not adjusted for multiple comparisons. P-value estimated using LR model including Wk2 baseline HAM-D6 total score, treatment, age \& gender as covariates.|Regression, Logistic|Non-responder imputation (NRI) for missing data, where missing post-baseline results were considered non-response||||||0.294
71010860|NCT02452892|141528590|SUPERIORITY|The persistence rate calculated based on Week 1 treatment group: 20 minutes LFMS, 60 minutes LFMS and sham therapy.||||||0.232||||||For 20min. LFMS, P-value not adjusted for multiple comparisons. P-value estimated using Logistic Regression model including Wk2 baseline HAM-D6 total score, treatment, age \& gender as covariates.|Regression, Logistic|Non-responder imputation (NRI) for missing data, where missing post-baseline results were considered non-response||||||0.232
71010861|NCT02452892|141528591|SUPERIORITY|||||||0.0932||||||P-value is not adjusted for multiple comparisons.|ANCOVA|P-value was estimated using ANCOVA model with treatment, age, \& gender as factors and baseline negative MADRS score as a covariate.||Estimates for LS Means, confidence intervals, difference in LS means and p-value are from an ANCOVA model with treatment, age, sex as factors and baseline negative MADRS score as a covariate.||||0.0932
71010862|NCT02452892|141528591|SUPERIORITY|||||||0.7509||||||The p-value is not adjusted for multiple comparisons.|ANCOVA|P-value was estimated using ANCOVA model with treatment, age, \& gender as factors and baseline negative MADRS score as a covariate.||Estimates for LS Means, confidence intervals, difference in LS means and p-value are from an ANCOVA model with treatment, age, sex as factors and baseline negative MADRS score as a covariate.||||0.7509
71010863|NCT02452892|141528592|SUPERIORITY|Positive score is the sum of 10 items: 1,3,5,9,10,12,14,16,17,19.||||||0.2672||||||P-value not adjusted for multiple comparisons.|ANCOVA|P-value estimated using ANCOVA model with treatment,age,\& gender as factors \& baseline positive PANAS score as a covariate.||||||0.2672
71010864|NCT02452892|141528592|SUPERIORITY|Positive score is the sum of 10 items: 1,3,5,9,10,12,14,16,17,19.||||||0.166||||||P-value not adjusted for multiple comparisons.|ANCOVA|P-value estimated using ANCOVA model with treatment,age,\& gender as factors \& baseline positive PANAS score as a covariate.||||||0.1660
71010865|NCT02452892|141528593|SUPERIORITY|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.0307||||||P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were considered as random missing data.|ANCOVA|P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~* All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~* The 72 data points were removed \& the negative score for affected subjects \& visits were not calculated.~* The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."||||0.0307
71010866|NCT02452892|141528593|SUPERIORITY|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.3537||||||"P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were considered as random missing data.~."|ANCOVA|P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~The 72 data points were removed \& the negative score for affected subjects \& visits were not calculated.~The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."||||0.3537
71010867|NCT02452892|141528594|SUPERIORITY|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.0848||||||P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were treated where incorrect Item #2 data was removed.|ANCOVA|P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~The 72 data points were removed \& the negative score for affected subjects \& visits were not calculated.~The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."||||0.0848
71010868|NCT02452892|141528594|SUPERIORITY|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.593||||||P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were treated where Incorrect Item #2 data was removed.|ANCOVA|P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~The 72 data points were removed \& the negative score for affected subjects \& visits were not calculated.~The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."||||0.5930
71010869|NCT02452892|141528595|SUPERIORITY|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.0307||||||P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were treated where incorrect Item #2 data was imputed using worst possible value.|ANCOVA|P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~The 72 data points were removed \& the negative score for affected subjects \& visits were not calculated.~The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."||||0.0307
71010870|NCT02452892|141528595|SUPERIORITY|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.3907||||||P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were treated where incorrect Item #2 data was imputed using worst possible value.|ANCOVA|P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~The 72 data points were removed \& the negative score for affected subjects \& visits were not calculated.~The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."||||0.3907
71010871|NCT02041533|141528651|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.15||||0.2511|TWO_SIDED|95.0|0.91|1.45|||Log Rank|Log-rank test stratified by histology (squamous vs. non-squamous) as entered into the IVRS.|Stratified Cox proportional hazard model. Hazard ratio of nivolumab to investigator's choice chemotherapy.|||1.45|0.91|0.2511
71010872|NCT02041533|141528652|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.95|1.43|||||Stratified Cox proportional hazard model. Hazard ratio of nivolumab to investigator's choice chemotherapy.|||1.43|0.95|
71010873|NCT02041533|141528653|SUPERIORITY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.79|1.2|||||Stratified Cox proportional hazard model. Hazard ratio of nivolumab to investigator's choice chemotherapy.|||1.20|0.79|
71010874|NCT02041533|141528654|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.86|1.24|||||Stratified Cox proportional hazard model. Hazard ratio of nivolumab to investigator's choice chemotherapy.|||1.24|0.86|
71010875|NCT02041533|141528655|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.46|1.06|||||Stratified by histology (squamous vs.non-squamous) at randomization. Strata adjusted odds ratio (Nivolumab over investigator choice of chemotherapy) using Mantel-Haenszel method.|||1.06|0.46|
71010876|NCT02117024|141528657|SUPERIORITY|||||||0.0011|||||||Log Rank|||||||0.0011
71010877|NCT02117024|141528657|OTHER||Hazard Ratio (HR)|1.0|||<|0.05|TWO_SIDED||||||Other|||With only 50% of enrollment complete prior to study termination by sponsor, insufficient sample size exists to fully complete efficacy analysis.||||<0.05
71010878|NCT02500706|141528700|NON_INFERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 1: Primary analysis: HbA1c non-inferiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog®.~Non-inferiority of mealtime faster aspart was considered confirmed if the upper boundary of the two-sided 95% CI was below or equal to 0.4%"|Treatment difference|-0.02|||<|0.001|TWO_SIDED|95.0|-0.11|0.07||p-value from the 2-sided test for treatment difference evaluated at the 5% level|ANOVA model after multiple imputation|||The endpoint was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline HbA1c as a covariate.||0.07|-0.11|<0.001
71010879|NCT02500706|141528700|NON_INFERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 2: HbA1c non-inferiority of postmeal faster aspart versus mealtime NovoRapid®/NovoLog®.~Non-inferiority of postmeal faster aspart was considered confirmed if the upper boundary of the two-sided 95% CI was below or equal to 0.4%"|Treatment difference|0.1|||<|0.001|TWO_SIDED|95.0|0.004|0.19||p-value from the 2-sided test for treatment difference evaluated at the 5% level.|ANOVA model after multiple imputation|||The endpoint was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline HbA1c as a covariate.||0.19|0.004|<0.001
71010880|NCT02500706|141528700|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 4: HbA1c superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog®.~Superiority was to be confirmed if the upper boundary of the two-sided 95% CI of the mean treatment difference (mealtime faster aspart minus mealtime NovoRapid®/NovoLog®) was below 0%-points."|Treatment difference|-0.02||||0.633|TWO_SIDED|95.0|-0.11|0.07||p-value from the 2-sided test for treatment difference evaluated at the 5% level|ANOVA model after multiple imputation|||The endpoint was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline HbA1c as a covariate.||0.07|-0.11|0.633
71010881|NCT02500706|141528701|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 3: 1-hour postprandial glucose (PPG) increments superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog.~Superiority was confirmed if the upper boundary of the two-sided 95% CI of the mean treatment difference (mealtime faster aspart minus mealtime NovoRapid®/NovoLog®) was below 0."|Treatment difference|-0.9|||<|0.001|TWO_SIDED|95.0|-1.36|-0.45||p-value from the 2-sided test for treatment difference evaluated at the 5% level.|ANOVA|||Change from baseline in postprandial glucose increment (meal test) is analysed using an analysis of variance model. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline postprandial glucose increment as a covariate.||-0.45|-1.36|<0.001
71010882|NCT02500706|141528702|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 5: 1,5-anhydroglucitol superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog®.~Superiority was to be confirmed if the lower boundary of the two-sided 95% CI of the mean treatment difference (mealtime faster aspart minus mealtime NovoRapid®/NovoLog®) was above 0."|Treatment difference|0.02||||0.924|TWO_SIDED|95.0|-0.31|0.34||p-values are from the 2-sided test for treatment difference evaluated at the 5% level.|ANOVA model after multiple imputation|||Change from baseline in 1,5-anhydroglucitol was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline 1,5-anhydroglucitol as a covariate.||0.34|-0.31|0.924
71010883|NCT00529152|141528750|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Regression, Linear|||Change in Serum Ferritin from baseline to week 24 was compared using regression analysis; null hypothesis was defined as no change in serum ferritin from baseline to week 24||||0.0005
71010884|NCT01497899|141528766|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the E/C/F/TAF group was at least 12% lower than the E/C/F/TDF group with respect to the percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 24. The alternative hypothesis was that the E/C/F/TAF group was less than 12% lower than the E/C/F/TDF group.|Difference in percentages|-2.9||||0.58|TWO_SIDED|95.0|-13.5|7.7|||Cochran-Mantel-Haenszel|P-value comparing the percentages of virologic success was from the Cochran-Mantel-Haenszel (CMH) test stratified by baseline HIV-1 RNA stratum.|Difference in percentages of virologic success and its 95% confidence interval (CI) were calculated based on baseline HIV-1 RNA stratum-adjusted Mantel-Haenszel (MH) proportion.|||7.7|-13.5|0.58
71010885|NCT01680835|141528770|OTHER|Freedom from primary safety composite event at 36 months compared to a performance goal of 35%|Kaplan Meier|0.771|||<|0.001|ONE_SIDED|97.5|0.678||||Log Rank||||||0.678|<0.001
71010886|NCT01680835|141528771|OTHER|No hypothesis Testing for this endpoint.|Kaplan Meier|1.0|STANDARD_ERROR_OF_MEAN|0.0|||TWO_SIDED|||||||||Stent Fracture at 1 Year||||
71010887|NCT01680835|141528771|OTHER|No hypothesis testing was done for this endpoint.|Kaplan Meier|0.989|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|||||||||Stent Fracture at 2 Years||||
71010888|NCT01680835|141528771|OTHER|No hypothesis testing was done for this endpoint|Kaplan Meier|0.965|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|||||||||Stent Fracture at 3 Years||||
71010889|NCT01680835|141528772|OTHER|No hypothesis testing was done at this endpoint|Kaplan Meier|0.86|STANDARD_ERROR_OF_MEAN|0.034|||TWO_SIDED|||||||||Freedom from acute death, freedom from amputation and freedom from clinically-driven target lesion revascularization at 1 year||||
71010890|NCT01680835|141528772|OTHER|No hypothesis testing was done for this endpoint.|Kaplan Meier|0.782|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|||||||||Freedom from acute death, freedom from amputation and freedom from clinically-driven target lesion revascularization at 2 years||||
71010891|NCT01680835|141528773|OTHER|No hypothesis testing was done for this endpoint.|Kaplan Meier|0.99|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|||||||||Estimate from freedom from major amputation through 3 years.||||
71010892|NCT01680835|141528774|OTHER||Kaplan Meier|0.781|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|||||||||Freedom from clinically-driven TLR through 3 Years||||
71010893|NCT05047601|141528781|SUPERIORITY||Risk Ratio (RR)|0.702||||0.1722|TWO_SIDED|95.0|0.422|1.167|||Generalized estimating equation (GEE)|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.167|0.422|0.1722
71010894|NCT05047601|141528781|SUPERIORITY||Risk Ratio (RR)|0.645||||0.1163|TWO_SIDED|95.0|0.373|1.115|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.115|0.373|0.1163
71010895|NCT05047601|141528783|SUPERIORITY||Risk Ratio (RR)|0.88||||0.6766|TWO_SIDED|95.0|0.484|1.602|||GEE|Model included the fixed effects of treatment, geographic regions. Compound symmetry variance-covariance structure.||||1.602|0.484|0.6766
71010896|NCT05047601|141528783|SUPERIORITY||Risk Ratio (RR)|0.809||||0.507|TWO_SIDED|95.0|0.433|1.512|||GEE|Model included the fixed effects of treatment, geographic regions. Compound symmetry variance-covariance structure.||||1.512|0.433|0.5070
71046777|NCT02712333|141602289|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|3.69|||<|0.01|TWO_SIDED|95.0|1.85|5.54||the p-value has been adjusted for multiple comparisons.|Mixed Models Analysis|||we analyzed the serum cortisone levels by treatment (intervention group vs control group)||5.54|1.85|<0.01
71010897|NCT05047601|141528785|SUPERIORITY||Risk Ratio (RR)|0.672||||0.1869|TWO_SIDED|95.0|0.373|1.213|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.213|0.373|0.1869
71010898|NCT05047601|141528785|SUPERIORITY||Risk Ratio (RR)|0.633||||0.1221|TWO_SIDED|95.0|0.355|1.13|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.130|0.355|0.1221
71010899|NCT05047601|141528786|SUPERIORITY|||||||0.0368|||||||Log Rank|||||||0.0368
71010900|NCT05047601|141528786|SUPERIORITY|||||||0.0186|||||||Log Rank|||||||0.0186
71010901|NCT05047601|141528787|SUPERIORITY||Risk Ratio (RR)|0.75||||0.4126|TWO_SIDED|95.0|0.378|1.491|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.491|0.378|0.4126
71010902|NCT05047601|141528787|SUPERIORITY||Risk Ratio (RR)|1.244||||0.4273|TWO_SIDED|95.0|0.725|2.135|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||2.135|0.725|0.4273
71010903|NCT05047601|141528788|SUPERIORITY||Risk Ratio (RR)|0.726||||0.1333|TWO_SIDED|95.0|0.478|1.103|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.103|0.478|0.1333
71010904|NCT05047601|141528788|SUPERIORITY||Risk Ratio (RR)|0.953||||0.8088|TWO_SIDED|95.0|0.645|1.408|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.408|0.645|0.8088
71010905|NCT05047601|141528796|SUPERIORITY||LS Mean Ratio|0.969||||0.7991|TWO_SIDED|95.0|0.758|1.238|||Negative binomial regression model|||||1.238|0.758|0.7991
71010906|NCT05047601|141528796|SUPERIORITY||LS Mean Ratio|0.847||||0.1985|TWO_SIDED|95.0|0.657|1.091|||Negative binomial regression model|||||1.091|0.657|0.1985
71010907|NCT02347124|141528799|SUPERIORITY||Odds Ratio (OR)|1.29||||0.13|TWO_SIDED|95.0|0.93|1.78||Adjusted for baseline sex, age, cigarettes per day, depression history, motivation, self-efficacy, current use of a stop-smoking medication, state quitline, and dental insurance.|Regression, Logistic|||||1.78|0.93|0.13
71010908|NCT02347124|141528800|SUPERIORITY||Odds Ratio (OR)|1.03||||0.9|TWO_SIDED|95.0|0.69|1.53||Adjusted for baseline sex, age, depression history, motivation, self-efficacy, state quitline, and dental insurance.|Regression, Logistic|||||1.53|0.69|0.90
71010909|NCT02347124|141528801|SUPERIORITY||Odds Ratio (OR)|1.22||||0.21|TWO_SIDED|95.0|0.89|1.69||Model is adjusted for sex, age, cigarettes per day at baseline, depression, self-efficacy, motivation, self-reported use of a stop smoking medication at baseline, and stratification variables state quit line and dental insurance.|Regression, Logistic|||||1.69|0.89|0.21
71010910|NCT02347124|141528802|SUPERIORITY||Odds Ratio (OR)|1.42||||0.04|TWO_SIDED|95.0|1.01|2.0||Model is adjusted for sex, age, cigarettes per day at baseline, depression, self-efficacy, motivation, self-reported use of a stop smoking medication at baseline, and stratification variables state quit line and dental insurance.|Regression, Logistic|||||2.00|1.01|0.04
71010911|NCT02347124|141528803|SUPERIORITY||Odds Ratio (OR)|1.37||||0.09|TWO_SIDED|95.0|0.95|1.96||Model is adjusted for sex, age, cigarettes per day at baseline, depression, self-efficacy, motivation, self-reported use of a stop smoking medication at baseline, and stratification variables state quit line and dental insurance.|Regression, Logistic|||||1.96|0.95|0.09
71010912|NCT02347124|141528804|SUPERIORITY||Odds Ratio (OR)|-0.05||||0.85|TWO_SIDED|95.0|-0.57|0.47|||Regression, Linear|Adjusted for sex, age, state quit line, and baseline knowledge score.||||0.47|-0.57|0.85
71010913|NCT02347124|141528805|SUPERIORITY||Odds Ratio (OR)|0.41||||0.14|TWO_SIDED|95.0|-0.14|0.96|||Regression, Linear|Adjusted for sex, age, state quit line, and baseline knowledge score.||||0.96|-0.14|0.14
71010914|NCT02347124|141528806|SUPERIORITY||Odds Ratio (OR)|0.35||||0.002|TWO_SIDED|95.0|0.13|0.56|||Regression, Linear|Adjusted for sex, age, state quit line, and baseline self-efficacy score.||||0.56|0.13|.002
71010915|NCT02347124|141528807|SUPERIORITY||Odds Ratio (OR)|0.0||||0.97|TWO_SIDED|95.0|-0.22|0.23||Adjusted for sex, age, state quit line, and baseline self-efficacy score.|Regression, Linear|||||0.23|-0.22|0.97
71010916|NCT02347124|141528808|SUPERIORITY||Odds Ratio (OR)|-0.1||||0.16|TWO_SIDED|95.0|-0.24|0.04|||Regression, Linear|Adjusted for sex, age, state quit line, use of stop-smoking medications, baseline motivation, and baseline cigarettes per day.||||0.04|-0.24|0.16
71010917|NCT02347124|141528809|SUPERIORITY||Odds Ratio (OR)|-0.02||||0.83|TWO_SIDED|95.0|-0.16|0.13|||Regression, Linear|Adjusted for sex, age, state quit line, use of a smoking cessation medication at baseline, baseline motivation score, and baseline cigarettes per day.||||0.13|-0.16|0.83
71010918|NCT02347124|141528810|SUPERIORITY||Odds Ratio (OR)|0.22||||0.02|TWO_SIDED|95.0|0.04|0.41|||Regression, Linear|adjusted for sex, age, state quit line, and baseline motivation score.||||0.41|0.04|0.02
71010919|NCT02347124|141528811|SUPERIORITY||Odds Ratio (OR)|0.02||||0.82|TWO_SIDED|95.0|-0.17|0.21|||Regression, Linear|||||0.21|-0.17|0.82
71010920|NCT02347124|141528812|SUPERIORITY||Odds Ratio (OR)|-0.02||||0.8|TWO_SIDED|95.0|-0.2|0.16|||Regression, Linear|Adjusted for sex, age, state quit line, baseline self-efficacy score, baseline cigarettes per day, and baseline use of stop smoking medications.||||0.16|-0.20|0.80
71010921|NCT02347124|141528813|SUPERIORITY||Odds Ratio (OR)|0.07||||0.45|TWO_SIDED|95.0|-0.11|0.26|||Regression, Linear|Adjusted for sex, age, state quit line, baseline self-efficacy score, baseline cigarettes per day, and baseline use of stop smoking medication.||||0.26|-0.11|0.45
71010922|NCT01522391|141528851|OTHER||Ratio between geometric means|0.045||||0.012|TWO_SIDED|95.0|0.004|0.491|||Mixed Models Analysis|||||0.491|0.004|0.012
71010923|NCT01522391|141528852|OTHER||Ratio between geometric means|0.045||||0.012|TWO_SIDED|95.0|0.004|0.491|||Mixed Models Analysis|||||0.491|0.004|0.012
71010924|NCT01522391|141528853|OTHER||Ratio between geometric means|0.242||||0.242|TWO_SIDED|95.0|0.022|2.66|||Mixed Models Analysis|||Day 7||2.66|0.022|0.242
71010925|NCT01522391|141528853|OTHER||Ratio between geometric means|0.428||||0.482|TWO_SIDED|95.0|0.039|4.696|||Mixed Models Analysis|||Day 21||4.696|0.039|0.482
71010926|NCT01522391|141528854|OTHER||Ratio between geometric means|0.242||||0.242|TWO_SIDED|95.0|0.022|2.66|||Mixed Models Analysis|||Day 7||2.660|0.022|0.242
71010927|NCT01522391|141528854|OTHER||Ratio between geometric means|0.428||||0.482|TWO_SIDED|95.0|0.039|4.696|||Mixed Models Analysis|||Day 21||4.696|0.039|0.482
71010928|NCT01522391|141528855|OTHER||Ratio between geometric means|0.288||||0.395|TWO_SIDED|95.0|0.016|5.221|||Mixed Models Analysis|||Day 7||5.221|0.016|0.395
71010929|NCT01522391|141528855|OTHER||Ratio between geometric means|0.067||||0.067|TWO_SIDED|95.0|0.004|1.218|||Mixed Models Analysis|||Day 14||1.218|0.004|0.067
70928631|NCT04800211|141353080|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|0.174||||0.2772|TWO_SIDED|95.0|-0.142|0.49|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||0.490|-0.142|0.2772
70941363|NCT02799745|141383292|SUPERIORITY||Hazard Ratio (HR)|0.714||||0.032|TWO_SIDED|95.0|0.525|0.972||P-value: from a 2-sided, stratified log-rank test.|Log Rank||HR and 95% CI for HR:based on Cox regression model assuming proportional hazards with treatment, prostate cancer risk, type of biopsy, baseline variables(as age, race), time since prostate cancer diagnosis as fixed effects and random effect of site.|||0.972|0.525|0.032
70941364|NCT02799745|141383293|SUPERIORITY||Odds Ratio (OR)|0.1||||0|TWO_SIDED|95.0|0.08|0.26||P-value:based on the exact binomial distribution from the logistic regression model.|Regression, Logistic||OR:from logistic regression model where treatment group, prostate cancer risk, type of biopsy, age, race and time since prostate cancer diagnosis were fixed covariates, site and participant were random effects. 95% CI:based on binomial distribution.|At the end of month 12||0.26|0.08|0.000
71010930|NCT01522391|141528855|OTHER||Ratio between geometric means|0.484||||0.62|TWO_SIDED|95.0|0.027|8.787|||Mixed Models Analysis|||Day 21||8.787|0.027|0.620
71010931|NCT01522391|141528856|OTHER||Ratio between geometric means|0.287||||0.403|TWO_SIDED|95.0|0.015|5.55|||Mixed Models Analysis|||Day 7||5.550|0.015|0.403
71010932|NCT01522391|141528856|OTHER||Ratio between geometric means|0.032||||0.021|TWO_SIDED|95.0|0.002|0.583|||Mixed Models Analysis|||Day 14||0.583|0.002|0.021
71010933|NCT01522391|141528856|OTHER||Ratio between geometric means|0.271||||0.368|TWO_SIDED|95.0|0.015|4.779|||Mixed Models Analysis|||Day 21||4.779|0.015|0.368
71010934|NCT01522391|141528857|OTHER||Ratio between geometric means|1.045||||0.97|TWO_SIDED|95.0|0.106|10.32|||Mixed Models Analysis|||Day 7||10.32|0.106|0.970
71010935|NCT01522391|141528857|OTHER||Ratio between geometric means|0.045||||0.009|TWO_SIDED|95.0|0.005|0.447|||Mixed Models Analysis|||Day 14||0.447|0.005|0.009
71010936|NCT01522391|141528857|OTHER||Ratio between geometric means|0.36||||0.377|TWO_SIDED|95.0|0.036|3.556|||Mixed Models Analysis|||Day 21||3.556|0.036|0.377
71010937|NCT01522391|141528858|OTHER||Ratio between geometric means|0.961||||0.974|TWO_SIDED|95.0|0.081|11.43|||Mixed Models Analysis|||Day 7||11.43|0.081|0.974
71010938|NCT01522391|141528858|OTHER||Ratio between geometric means|0.046||||0.013|TWO_SIDED|95.0|0.004|0.512|||Mixed Models Analysis|||Day 14||0.512|0.004|0.013
71010939|NCT01522391|141528858|OTHER||Ratio between geometric means|0.447||||0.504|TWO_SIDED|95.0|0.041|4.883|||Mixed Models Analysis|||Day 21||4.883|0.041|0.504
71010940|NCT01522391|141528859|OTHER||Ratio between geometric means|0.242||||0.242|TWO_SIDED|95.0|0.022|2.659|||Mixed Models Analysis|||Day 7||2.659|0.022|0.242
71046778|NCT02712333|141602289|SUPERIORITY_OR_OTHER||fold change|1.18|||<|0.01|TWO_SIDED||||||t-test, 2 sided||fold change is calculated by measurments from the sham purification group/measurements from the real purification group|||||<0.01
71010941|NCT01522391|141528859|OTHER||Ratio between geometric means|0.045||||0.012|TWO_SIDED|95.0|0.004|0.491|||Mixed Models Analysis|||Day 14||0.491|0.004|0.012
71010942|NCT01522391|141528859|OTHER||Ratio between geometric means|0.428||||0.483|TWO_SIDED|95.0|0.039|4.697|||Mixed Models Analysis|||Day 21||4.697|0.039|0.483
71010943|NCT01522391|141528860|OTHER||Ratio between geometric means|0.202||||0.197|TWO_SIDED|95.0|0.017|2.34|||Mixed Models Analysis|||Day 7||2.340|0.017|0.197
71010944|NCT01522391|141528860|OTHER||Ratio between geometric means|0.021||||0.002|TWO_SIDED|95.0|0.002|0.227|||Mixed Models Analysis|||Day 14||0.227|0.002|0.002
71010945|NCT01522391|141528860|OTHER||Ratio between geometric means|0.257||||0.257|TWO_SIDED|95.0|0.024|2.752|||Mixed Models Analysis|||Day 21||2.752|0.024|0.257
71010946|NCT01522391|141528861|OTHER||Least Square Mean Difference|20.38||||0.346|TWO_SIDED|95.0|-22.42|63.19|||Mixed Models Analysis|||Day 7||63.19|-22.42|0.346
71010947|NCT01522391|141528861|OTHER||Least Square Mean Difference|29.1||||0.18|TWO_SIDED|95.0|-13.71|71.9|||Mixed Models Analysis|||Day 14||71.90|-13.71|0.18
71010948|NCT01522391|141528861|OTHER||Least Square Mean Difference|-11.64||||0.59|TWO_SIDED|95.0|-54.44|31.16|||Mixed Models Analysis|||Day 21||31.16|-54.44|0.590
71010949|NCT01522391|141528862|OTHER||Least Square Mean Difference|5.95||||0.748|TWO_SIDED|95.0|-30.84|42.73|||Mixed Models Analysis|||Day 7||42.73|-30.84|0.748
71010950|NCT01522391|141528862|OTHER||Least Square Mean Difference|14.62||||0.437|TWO_SIDED|95.0|-22.65|51.88|||Mixed Models Analysis|||Day 14||51.88|-22.65|0.437
71010951|NCT01522391|141528862|OTHER||Least Square Mean Difference|-18.66||||0.322|TWO_SIDED|95.0|-55.92|18.61|||Mixed Models Analysis|||Day 21||18.61|-55.92|0.322
71010952|NCT01522391|141528863|OTHER||Least Square Mean Difference|8.04||||0.631|TWO_SIDED|95.0|-25.15|41.24|||Mixed Models Analysis|||Day 7||41.24|-25.15|0.631
71010953|NCT01522391|141528863|OTHER||Least Square Mean Difference|20.44||||0.224|TWO_SIDED|95.0|-12.75|53.63|||Mixed Models Analysis|||Day 14||53.63|-12.75|0.224
71010954|NCT01522391|141528863|OTHER||Least Square Mean Difference|-1.23||||0.941|TWO_SIDED|95.0|-34.42|31.96|||Mixed Models Analysis|||Day 21||31.96|-34.42|0.941
71010955|NCT01522391|141528864|OTHER||Least Square Means Difference|0.97||||0.954|TWO_SIDED|95.0|-32.93|34.87|||Mixed Models Analysis|||Day 7||34.87|-32.93|0.954
71010956|NCT01522391|141528864|OTHER||Least Square Mean Difference|15.72||||0.358|TWO_SIDED|95.0|-18.18|49.62|||Mixed Models Analysis|||Day 14||49.62|-18.18|0.358
71010957|NCT01522391|141528864|OTHER||least Square Mean Difference|-7.94||||0.642|TWO_SIDED|95.0|-41.82|25.94|||Mixed Models Analysis|||Day 21||25.94|-41.82|0.642
71010958|NCT01522391|141528865|OTHER|||||||0.701|||||||Cochran-Mantel-Haenszel|||Day 7||||0.701
71010959|NCT01522391|141528865|OTHER|||||||0.898|||||||Cochran-Mantel-Haenszel|||Day 14||||0.898
70941365|NCT02799745|141383293|SUPERIORITY||Odds Ratio (OR)|1.1||||0.807|TWO_SIDED|95.0|0.37|3.53||P-value: based on the exact binomial distribution from the logistic regression model.|Regression, Logistic||OR: from logistic regression model where treatment group, prostate cancer risk, type of biopsy, age, race and time since prostate cancer diagnosis were fixed covariates, site and participant were random effects. 95% CI:based on binomial distribution.|At the end of month 24||3.53|0.37|0.807
71010960|NCT01522391|141528865|OTHER|||||||0.271|||||||Cochran-Mantel-Haenszel|||Day 21||||0.271
71010961|NCT01522391|141528866|OTHER|||||||0.511|||||||Cochran-Mantel-Haenszel|||Day 7||||0.511
71010962|NCT01522391|141528866|OTHER|||||||0.777|||||||Cochran-Mantel-Haenszel|||Day 14||||0.777
71010963|NCT01522391|141528866|OTHER|||||||0.204|||||||Cochran-Mantel-Haenszel|||Day 21||||0.204
71010964|NCT01522391|141528867|OTHER|||||||0.489|||||||Cochran-Mantel-Haenszel|||Day 7||||0.489
71010965|NCT01522391|141528867|OTHER|||||||0.249|||||||Cochran-Mantel-Haenszel|||Day 14||||0.249
71010966|NCT01522391|141528867|OTHER|||||||0.098|||||||Cochran-Mantel-Haenszel|||Day 21||||0.098
71010967|NCT01522391|141528868|OTHER|||||||0.291|||||||Cochran-Mantel-Haenszel|||Day 7||||0.291
71010968|NCT01522391|141528868|OTHER|||||||0.113|||||||Cochran-Mantel-Haenszel|||Day 14||||0.113
71010969|NCT01522391|141528868|OTHER|||||||0.033|||||||Cochran-Mantel-Haenszel|||Day 21||||0.033
70941366|NCT02799745|141383293|SUPERIORITY||Odds Ratio (OR)|1.0||||0.931|TWO_SIDED|95.0|0.5|2.15||P-value:based on the exact binomial distribution from the logistic regression model.|Regression, Logistic||OR: from logistic regression model where treatment group, prostate cancer risk, type of biopsy, age, race and time since prostate cancer diagnosis were fixed covariates, site and participant were random effects. 95% CI:based on binomial distribution.|At the end of study||2.15|0.50|0.931
71010970|NCT01522391|141528869|OTHER|||||||0.825|||||||Cochran-Mantel-Haenszel|||Day 7||||0.825
71010971|NCT01522391|141528869|OTHER|||||||0.825|||||||Cochran-Mantel-Haenszel|||Day 14||||0.825
71010972|NCT01522391|141528869|OTHER|||||||0.208|||||||Cochran-Mantel-Haenszel|||||||0.208
71010973|NCT01522391|141528870|OTHER|||||||0.825|||||||Cochran-Mantel-Haenszel|||Day 7||||0.825
71046779|NCT02712333|141602290|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|5.17|||<|0.01|TWO_SIDED|95.0|3.21|7.14||the p-value has been adjusted for multiple comparisons.|Mixed Models Analysis|||we analyzed the serum epinephrine levels by treatment (intervention group vs control group)||7.14|3.21|<0.01
71010974|NCT01522391|141528870|OTHER|||||||0.82|||||||Cochran-Mantel-Haenszel|||Day 14||||0.820
71010975|NCT01522391|141528870|OTHER|||||||0.086|||||||Cochran-Mantel-Haenszel|||Day 21||||0.086
71010976|NCT01522391|141528871|OTHER|||||||0.378|||||||Cochran-Mantel-Haenszel|||Day 7||||0.378
71010977|NCT01522391|141528871|OTHER|||||||0.975|||||||Cochran-Mantel-Haenszel|||Day 14||||0.975
71010978|NCT01522391|141528871|OTHER|||||||0.962|||||||Cochran-Mantel-Haenszel|||Day 21||||0.962
71010979|NCT01522391|141528872|OTHER|||||||0.375|||||||Cochran-Mantel-Haenszel|||Day 7||||0.375
71010980|NCT01522391|141528872|OTHER|||||||0.946|||||||Cochran-Mantel-Haenszel|||Day 14||||0.946
71010981|NCT01522391|141528872|OTHER|||||||0.495|||||||Cochran-Mantel-Haenszel|||Day 21||||0.495
71010982|NCT01522391|141528875|OTHER|||||||0.477|||||||Wilcoxon (Mann-Whitney)|||Day 7 morning||||0.477
71010983|NCT01522391|141528875|OTHER|||||||0.651|||||||Wilcoxon (Mann-Whitney)|||Day 14 morning||||0.651
71010984|NCT01522391|141528875|OTHER|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Day 21 morning||||0.340
71010985|NCT01522391|141528876|OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Day 7 morning||||0.300
71010986|NCT01522391|141528876|OTHER|||||||0.705|||||||Wilcoxon (Mann-Whitney)|||Day 14||||0.705
71010987|NCT01522391|141528876|OTHER|||||||0.286|||||||Wilcoxon (Mann-Whitney)|||Day 21||||0.286
71010988|NCT00877929|141528879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||0.0001||95.0|-7.9|-4.2|||ANCOVA|Included effects of treatment, week and treatment-by-week interaction with covariate of baseline blood pressure and baseline-week interaction.||||-4.2|-7.9|0.0001
71010989|NCT00877929|141528880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.1||||0.0001||95.0|-8.9|-5.4|||ANCOVA|Included effects of treatment, week and treatment-by-week interaction with covariate of baseline blood pressure and baseline-week interaction.||||-5.4|-8.9|0.0001
71010990|NCT00877929|141528881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6||||0.0001||95.0|-8.3|-4.9|||ANCOVA|Included effects of treatment, week and treatment-by-week interaction with covariate of baseline blood pressure and baseline-week interaction.||||-4.9|-8.3|0.0001
71010991|NCT00877929|141528882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||0.0001||95.0|-7.9|-4.3|||ANCOVA|Included effects of treatment, week and treatment-by-week interaction with covariate of baseline blood pressure and baseline-week interaction.||||-4.3|-7.9|0.0001
71010992|NCT00877929|141528883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9||||0.0001||95.0|-6.6|-3.2|||ANCOVA|Included effects of treatment, week and treatment-by-week interaction with covariate of baseline blood pressure and baseline-week interaction.||||-3.2|-6.6|0.0001
71010993|NCT03006276|141528920|SUPERIORITY||Odds Ratio (OR)|2.0|||<|0.001|TWO_SIDED|95.0|1.36|2.94|||Fisher Exact|||Last Observation Carried Forward (LOCF)||2.94|1.36|<0.001
71010994|NCT03006276|141528920|SUPERIORITY||Odds Ratio (OR)|1.97|||<|0.001|TWO_SIDED|95.0|1.34|2.89|||Fisher Exact|||||2.89|1.34|<0.001
71010995|NCT03006276|141528921|SUPERIORITY||Odds Ratio (OR)|1.68||||0.007|TWO_SIDED|95.0|1.17|2.43|||Fisher Exact|||last observation carried forward (LOCF)||2.43|1.17|0.007
71010996|NCT03006276|141528921|SUPERIORITY||Odds Ratio (OR)|1.69||||0.007|TWO_SIDED|95.0|1.16|2.44|||Fisher Exact|||observed cases (OC)||2.44|1.16|0.007
71010997|NCT02127931|141528938|OTHER|||||||0.005|||||||Correlation|||ADHD-I||||0.005
71010998|NCT02127931|141528938|OTHER|||||||0.023|||||||Correlation|||ADHD-C||||0.023
71010999|NCT02127931|141528939|OTHER|||||||0.013|||||||Correlation|||||||0.013
71011000|NCT02828982|141528954|SUPERIORITY|||||||0.585||||||Statistical significance was set a-priori at p\<0.05|t-test, 2 sided|||The null hypothesis was that there would be no difference in metabolic costs between the two groups||||0.585
71011001|NCT02828982|141528955|SUPERIORITY|||||||0.452||||||Statistical significance was set a-priori at p\<0.05|t-test, 2 sided|||The null hypothesis was that there were no differences in the number of steps taken outside of the home for the two prostheses.||||0.452
71046780|NCT02712333|141602290|SUPERIORITY_OR_OTHER||fold change|1.2|||<|0.01|TWO_SIDED||||||t-test, 2 sided||fold change is calculated by measurments from the sham purification group/measurements from the real purification group|||||<0.01
71046781|NCT02712333|141602291|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|11.28|||<|0.01|TWO_SIDED|95.0|7.37|15.21||the p-value has been adjusted for multiple comparisons|Mixed Models Analysis|||we analyzed the serum norepinephrine levels by treatment (intervention group vs control group)||15.21|7.37|<0.01
71046782|NCT02712333|141602291|SUPERIORITY_OR_OTHER||fold change|1.57|||<|0.01|TWO_SIDED||||||t-test, 2 sided||fold change is calculated by measurments from the sham purification group/measurements from the real purification group|||||<0.01
71046783|NCT02712333|141602292|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|0.84|||<|0.01|TWO_SIDED|95.0|0.09|1.59|||Mixed Models Analysis|||we analyzed the serum SBP levels by treatment (intervention group vs control group)||1.59|0.09|<0.01
71046784|NCT02712333|141602293|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|0.31|||>|0.05|TWO_SIDED|95.0|-1.59|0.96|||Mixed Models Analysis|||we analyzed the serum cortisol levels by treatment (intervention group vs control group)||0.96|-1.59|>0.05
71046785|NCT02712333|141602294|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|1.24|||>|0.05|TWO_SIDED|95.0|-1.14|3.63|||Mixed Models Analysis|||we analyzed the serum cortisol levels by treatment (intervention group vs control group)||3.63|-1.14|>0.05
71046786|NCT02278718|141602302|SUPERIORITY|||||||0.0008|||||||Generalized Wilcoxon-Gehan Test|||Wilcoxon test statistic was estimated using generalized Wilcoxon-Gehan test stratified by center group, age group, % TBSA group, proportion of FT area group and number of TWs group. A negative (positive) statistic is associated with longer (shorter) time to the event when treated with NexoBrid vs. Standard of Care. P-value was calculated using the re-randomization test.||||0.0008
71046787|NCT02278718|141602303|SUPERIORITY||Odds Ratio (OR)|0.025|||<|0.0001|TWO_SIDED|95.0|0.007|0.09|||Fisher Exact|||Incidence of Surgical Excision for Eschar Removal for NexoBrid vs SOC||0.090|0.007|<0.0001
71046788|NCT02278718|141602304|SUPERIORITY|||||||0.1374|||||||t-test, 2 sided|||||||0.1374
71046789|NCT02278718|141602305|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.5045|TWO_SIDED||||||t-test, 2 sided|||||||0.5045
71046790|NCT02278718|141602306|SUPERIORITY||Odds Ratio (OR)|0.414||||0.0545|TWO_SIDED|95.0|0.163|1.054|||t-test, 2 sided|||||1.054|0.163|0.0545
71046791|NCT04440449|141602315|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
71046792|NCT04440449|141602316|SUPERIORITY|||||||0.108|||||||t-test, 2 sided|||||||0.108
71046793|NCT03212794|141602320|SUPERIORITY||||||=|0.87||||||Threshold for significance p\<0.05|Chi-squared|||||||=0.87
71046794|NCT03212794|141602321|SUPERIORITY||||||=|0.82||||||Threshold for significance p\<0.05|Chi-squared|||||||=0.82
71046795|NCT03212794|141602322|OTHER||||||=|0.92||||||Threshold for significance p\<0.05|Log Rank|If no event occurred, the data from those individuals were right censored.||||||=0.92
71046796|NCT03212794|141602323|OTHER||||||=|0.85||||||Threshold for significance p\<0.05|Log Rank|If no event occurred, the data from those individuals were right censored.||||||=0.85
71046797|NCT01763918|141602324|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-59.23|STANDARD_ERROR_OF_MEAN|2.98|<|0.001|TWO_SIDED|95.0|-65.11|-53.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||Within each dose frequency, the null hypothesis was that there was no mean difference in the percent change from baseline at week 12 or in the percent change from baseline at the mean of weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-53.35|-65.11|<0.001
71046798|NCT01763918|141602324|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-61.27|STANDARD_ERROR_OF_MEAN|3.91|<|0.001|TWO_SIDED|95.0|-69.0|-53.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||Within each dose frequency, the null hypothesis was that there was no mean difference in the percent change from baseline at week 12 or in the percent change from baseline at the mean of weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-53.55|-69.00|<0.001
71046799|NCT01763918|141602325|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.15|STANDARD_ERROR_OF_MEAN|2.88|<|0.001|TWO_SIDED|95.0|-65.83|-54.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||Within each dose frequency, the null hypothesis was that there was no mean difference in the percent change from baseline at week 12 or in the percent change from baseline at the mean of weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-54.46|-65.83|<0.001
71046800|NCT01763918|141602325|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-65.55|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|-71.27|-59.83||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||Within each dose frequency, the null hypothesis was that there was no mean difference in the percent change from baseline at week 12 or in the percent change from baseline at the mean of weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-59.83|-71.27|<0.001
71046801|NCT01763918|141602326|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-95.2|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-105.1|-85.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-85.2|-105.1|<0.001
70928632|NCT04800211|141353080|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-4.014|||<|0.0001|TWO_SIDED|95.0|-4.75|-3.278|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-3.278|-4.750|<.0001
70941367|NCT00635570|141383305|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||Chi-squared, Corrected|Yates's chi-squared test with 1 degree of freedom was used for analysis||The trial sample size of 300 participants total (150 participants each group) was based on two-sided 5% significance testing with 80% power to detect a difference of 10% in adherence between students in the contraceptive vaginal ring group and oral contraceptive pill group.||||0.05
70941368|NCT00635570|141383306|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED|0.0|||||Chi-squared, Corrected|||||||>0.05
71046802|NCT01763918|141602326|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-97.4|STANDARD_ERROR_OF_MEAN|4.9|<|0.001|TWO_SIDED|95.0|-107.1|-87.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-87.7|-107.1|<0.001
71046803|NCT01763918|141602327|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-92.9|STANDARD_ERROR_OF_MEAN|5.1|<|0.001|TWO_SIDED|95.0|-102.9|-82.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-82.8|-102.9|<0.001
71046804|NCT01763918|141602327|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-91.3|STANDARD_ERROR_OF_MEAN|6.3|<|0.001|TWO_SIDED|95.0|-103.8|-78.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-78.9|-103.8|<0.001
71046805|NCT01763918|141602328|SUPERIORITY_OR_OTHER||Treatment Difference|65.1|||<|0.001|TWO_SIDED|95.0|52.8|73.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and ezetimibe use.||||73.4|52.8|<0.001
71046806|NCT01763918|141602328|SUPERIORITY_OR_OTHER||Treatment Difference|78.5|||<|0.001|TWO_SIDED|95.0|66.9|85.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and ezetimibe use.||||85.1|66.9|<0.001
71046807|NCT01763918|141602329|SUPERIORITY_OR_OTHER||Treatment Difference|66.3|||<|0.001|TWO_SIDED|95.0|53.7|74.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and ezetimibe use||||74.6|53.7|<0.001
71046808|NCT01763918|141602329|SUPERIORITY_OR_OTHER||Treatment Difference|60.9|||<|0.001|TWO_SIDED|95.0|47.6|69.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and ezetimibe use.||||69.8|47.6|<0.001
71046809|NCT01763918|141602330|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-56.0|STANDARD_ERROR_OF_MEAN|2.74|<|0.001|TWO_SIDED|95.0|-61.41|-50.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-50.59|-61.41|<0.001
71046810|NCT01763918|141602330|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.01|STANDARD_ERROR_OF_MEAN|2.65|<|0.001|TWO_SIDED|95.0|-65.24|-54.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-54.77|-65.24|<0.001
71046811|NCT01763918|141602331|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-54.79|STANDARD_ERROR_OF_MEAN|2.87|<|0.001|TWO_SIDED|95.0|-60.47|-49.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-49.12|-60.47|<0.001
71046812|NCT01763918|141602331|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-54.95|STANDARD_ERROR_OF_MEAN|3.54|<|0.001|TWO_SIDED|95.0|-61.95|-47.96||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-47.96|-61.95|<0.001
71046813|NCT01763918|141602332|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.39|STANDARD_ERROR_OF_MEAN|2.5|<|0.001|TWO_SIDED|95.0|-54.32|-44.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-44.46|-54.32|<0.001
71046814|NCT01763918|141602332|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-54.98|STANDARD_ERROR_OF_MEAN|2.33|<|0.001|TWO_SIDED|95.0|-59.58|-50.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-50.38|-59.58|<0.001
70941369|NCT00635570|141383307|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
70941370|NCT00635570|141383308|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
70928633|NCT04800211|141353080|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-4.115|||<|0.0001|TWO_SIDED|95.0|-4.865|-3.365|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-3.365|-4.865|<.0001
70941371|NCT02552810|141383329|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculation, 30 (effect size: 0.5, alpha error: 0.05, power: 0.80).|||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70941372|NCT03327051|141383398|OTHER|An increase in relative abundance of VSL3 bacterial strains at week 4 compared to week 0 (baseline) is considered significant if p\<0.05.||||||0.04|||||||ANOVA|Two-way ANOVA with Bonferroni post-test was used for multi-variable analysis||Within group difference between week 0 and week 4 was analyzed.||||0.04
71011002|NCT02828982|141528956|OTHER|paired t-test of Physical component scores between the two conditions||||||0.48||||||a prior threshold for significance was 0.05|t-test, 2 sided|||||||0.480
71011003|NCT02828982|141528956|SUPERIORITY|||||||0.408||||||Statistical significance was set a-priori at p\<0.05|t-test, 2 sided|||Mental Component Score||||0.408
71011004|NCT02828982|141528957|SUPERIORITY|||||||0.058||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Ambulation Score||||0.058
71011005|NCT02828982|141528957|OTHER|paired t-test between conditions||||||0.123||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Appearance Score||||.123
71011006|NCT02828982|141528957|OTHER|paired t-test between conditions||||||0.052||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Frustration Score||||.052
71011007|NCT02828982|141528957|OTHER|paired t-test between conditions||||||0.188||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Perceived Response Score||||.188
71011008|NCT02828982|141528957|OTHER|paired t-test between conditions||||||0.336||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Residual Limb Health Score||||.336
71011009|NCT02828982|141528957|OTHER|paired t-test between conditions||||||0.043||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Social Burden Score||||.043
71011010|NCT02828982|141528957|OTHER|paired t-test between conditions||||||0.391||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Sounds Score||||.391
71011011|NCT02828982|141528957|SUPERIORITY|paired t-test between conditions||||||0.799||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Utility Score||||.799
71011012|NCT02828982|141528957|SUPERIORITY|||||||0.173||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Well-Being||||.173
71011013|NCT02828982|141528958|OTHER|paired t-test between conditions||||||0.655||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Intact Side Biceps Femoris||||0.655
71011014|NCT02828982|141528958|OTHER|paired t-test between conditions||||||0.281||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Intact Side Rectus Femoris||||.281
71011015|NCT02828982|141528958|OTHER|paired t-test between conditions||||||0.844||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Intact Side Soleus||||.844
71011016|NCT02828982|141528958|OTHER|paired t-test between conditions||||||0.11||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Intact Side Tibialis Anterior||||.110
71011017|NCT02828982|141528958|OTHER|paired t-test between conditions||||||0.394||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Residual Side Biceps Femoris||||.394
71011018|NCT02828982|141528958|SUPERIORITY|||||||0.141||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Residual Side Rectus Femoris||||.141
71011019|NCT02828982|141528959|SUPERIORITY|||||||0.212||||||Statistical significance was set a-priori at p\<0.05|t-test, 2 sided|||||||0.212
71011020|NCT03691831|141528960|SUPERIORITY||Odds Ratio (OR)|4.8||||0.0001|TWO_SIDED|95.0|2.14|10.76||P-Value test comparing the Patients Cleared of All Baseline Warts in the Active (A-101 45%) and vehicle groups.|Mixed Models Analysis|||A summary of the wart clearance at Visit 10.||10.76|2.14|0.0001
71011021|NCT03691831|141528961|SUPERIORITY||Mean Difference (Final Values)|2.71||||0.0001|TWO_SIDED|95.0|1.61|4.56|||Mixed Models Analysis|||P-Value test comparing the Patients Cleared of All Baseline Warts in the Active (A-101 45%) and vehicle groups.||4.56|1.61|0.0001
71011022|NCT03691831|141528962|SUPERIORITY||Odds Ratio (OR)|15.44|||<|0.0001|TWO_SIDED|95.0|9.0|21.8|||Wilcoxon (Mann-Whitney)|||||21.8|9.0|<0.0001
71011023|NCT03691831|141528963|SUPERIORITY||Odds Ratio (OR)|5.2||||0.0006|TWO_SIDED|95.0|1.76|15.53|||Wilcoxon (Mann-Whitney)|||||15.53|1.76|0.0006
71011024|NCT03691831|141528964|SUPERIORITY||Hazard Ratio (HR)|3.33|||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
71011025|NCT03922945|141528965|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71011026|NCT03922945|141528966|SUPERIORITY||||||<|0.0017|||||||Cochran-Mantel-Haenszel|||||||<0.0017
71011027|NCT03922945|141528973|SUPERIORITY|||||||0.7465|||||||Mixed Models Analysis|||||||0.7465
71011028|NCT04250558|141528980|OTHER|||||||0.05|||||||Regression, Logistic|||Kinetic parameters were assessed by Mann-Whitney U test in MATLAB Statistics and Machine Learning Toolbox. Receiver operating characteristic (ROC) analysis based on logistic regression was utilized, with one surgical condition versus the other two states as the binary dependent variable, and each perfusion-related kinetic parameter of Imax, IS and BF as the independent variable. Power analysis was performed to evaluate the statistical validity, using G\*Power software||||0.05
71046815|NCT01763918|141602333|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.09|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-54.55|-43.63||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-43.63|-54.55|<0.001
71011029|NCT00772031|141528983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.97||0.77|TWO_SIDED|95.0|-1.8|2.4|||ANCOVA|covariate adjustments: study site, baseline mod-to-sev 28-day headache-rate, topiramate use, medication overuse, and anti-depressive medications use.|Topiramate plus placebo mean reduction minus topiramate plus propranolol reduction|The study was designed to enroll 250 subjects to provide at least 90% power to detect a 3-day difference and 87% power to detect a 2.5-day difference in 28-day moderate-to-severe headache rate reductions at six months, assuming a type I error rate of 0.05, a two-sided test, a 10% loss to follow-up and a standard deviation of within-person change in days with headache of six.||2.4|-1.8|0.77
71011030|NCT00772031|141528984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44|||||TWO_SIDED|95.0|0.75|2.78||||||||2.78|0.75|
71011031|NCT00772031|141528985|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||||95.0|0.5|2.02||||||||2.02|0.50|
71011032|NCT00772031|141528987|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28|STANDARD_DEVIATION|3.75||0.91||95.0|||||ANCOVA|||||||0.91
71011033|NCT02681094|141528991|SUPERIORITY||LS mean difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.55|-0.24|||Mixed Models Analysis|||||-0.24|-0.55|<0.0001
71011034|NCT02681094|141528991|SUPERIORITY||LS mean difference|-0.34|||<|0.0001|TWO_SIDED|95.0|-0.5|-0.19|||Mixed Models Analysis|||||-0.19|-0.50|<0.0001
71011035|NCT02681094|141528992|SUPERIORITY||Risk Difference (RD)|19.8|||<|0.0001|TWO_SIDED|95.0|12.7|26.9|||Method of Zhang, Tsiatis, and Davidian|||||26.9|12.7|<0.0001
71011036|NCT02681094|141528992|SUPERIORITY||Risk Difference (RD)|11.7||||0.0018|TWO_SIDED|95.0|4.4|19.1|||Method of Zhang, Tsiatis, and Davidian|||||19.1|4.4|0.0018
71011037|NCT02681094|141528993|SUPERIORITY||LS mean difference|-7.58||||0.0135|TWO_SIDED|95.0|-13.59|-1.57|||Mixed Models Analysis|||||-1.57|-13.59|0.0135
71011038|NCT02681094|141528993|SUPERIORITY||LS mean difference|-14.88|||<|0.0001|TWO_SIDED|95.0|-20.85|-8.91|||Mixed Models Analysis|||||-8.91|-20.85|<0.0001
71103762|NCT00721110|141715020|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.63|TWO_SIDED|97.5|-7.0|7.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Lidocaine versus nonlidocaine on intraoperative opioid consumption was assessed using the Wilcoxon rank sum test.||7|-7|0.63
70941373|NCT03327051|141383398|OTHER|An increase in relative abundance of VSL3 bacterial strains at week 4 compared to week 0 (baseline) is considered significant if p\<0.05.|||||>|0.99|||||||ANOVA|Two-way ANOVA with Bonferroni post-test was used for multi-variable analysis||Within group difference between week 0 and week 4 was analyzed.||||>0.99
71011039|NCT02681094|141528994|SUPERIORITY||LS mean difference|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.11|-1.09|||Mixed Models Analysis|||||-1.09|-2.11|<0.0001
71011040|NCT01098266|141529005|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.58|TWO_SIDED|95.0|0.75|1.18||The log-rank test (unstratified) was used to compare the two treatment arms. In addition, a stratified version of the log-rank test was performed with the stratification factors used for randomization.|Log Rank|Cox regression analyses (unstratified and stratified) were performed to assess the influence of baseline covariates in an exploratory manner.||Study with one control per experimental patient, an accrual interval of 24 months, and an additional FU after the accrual interval of 12 months.If the true HR of experimental relative to control patients was 0.726, then 195 experimental patients and 195 control patients were required to be able to reject the null hypothesis that the experimental and control survival curves were equal with probability (power)0.80 Type I error probability associated with this test of this null hypothesis was 0.05||1.18|0.75|0.58
71011041|NCT01098266|141529006|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.65|TWO_SIDED|95.0|0.78|1.17|||Log Rank|Cox regression analyses (unstratified and stratified) was performed to assess the influence of baseline covariates in an exploratory manner.||The log-rank test (unstratified and stratified) was used at an alpha level of 5% to test for differences in PFS between the two treatment arms. Kaplan-Meier curves and estimates were provided.||1.17|0.78|0.65
71011042|NCT01098266|141529007|SUPERIORITY||Odds Ratio (OR)|1.13||||0.62|TWO_SIDED|95.0|0.76|1.68|||Fisher Exact||Logistic regression analyses were performed to assess the influence of baseline covariates in an exploratory manner|Difference in DCR between the two treatment arms were tested using a chi-squared test with 95% confidence intervals calculated in each treatment arm.||1.68|0.76|0.62
71011043|NCT01098266|141529010|OTHER|Two-sided log-rank test was used to compare time to symptomatic progression between treatment arms. Median and 95% confidence limits for the time to symptomatic progression were estimated using Kaplan-Meier survival methodology. Estimates of the treatment effect were expressed as hazard ratio including 95% confidence intervals.|Hazard Ratio (HR)|0.92||||0.5806|TWO_SIDED|95.0|0.68|1.26|||Log Rank|||QoL assessment was performed by using a questionnaire according to LCSS, which consists of nine 100-mm visual analog scales, with scores reported from 0 to 100(the best score). The LCSS subscore is the average symptom burden index computed as the mean score for all 6 major symptoms. Symptomatic progression was defined as a worsening in the average symptom burden index by 25%.||1.26|0.68|0.5806
71011044|NCT01111058|141529023|SUPERIORITY||Difference in survival proportions|0.0022||||0.9|TWO_SIDED|95.0|-0.33|0.33|||Comparison of Kaplan-Meier estimates|Used Greenwood standard errors||||0.33|-0.33|0.90
71011045|NCT01111058|141529023|SUPERIORITY|||||||0.54|||||||Log Rank|||||||0.54
71011046|NCT01111058|141529024|SUPERIORITY|||||||0.086|||||||Fisher Exact|||||||0.086
71011047|NCT01733758|141529032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.55|||||TWO_SIDED|95.0|-1.72|-1.39|||ANCOVA|||||-1.39|-1.72|
71011048|NCT01733758|141529032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.35|||||TWO_SIDED|95.0|-1.51|-1.18|||ANCOVA|||||-1.18|-1.51|
71011049|NCT01733758|141529032|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The first test in a sequential testing procedure starting with albiglutide 50 mg versus placebo, and if significant at 0.05 level, followed by albiglutide 30 mg versus placebo.|t-test, 2 sided|The p-value is from a 2-sided t-test to test whether the difference of least squares (LS) means (albiglutide 50 mg - placebo) is equal to zero.||||||<0.0001
71103763|NCT00721110|141715020|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.0||||0.27|TWO_SIDED|97.5|-10.0|5.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Ketamine versus nonketamine on intraoperative opioid consumption was assessed using a Wilcoxon rank sum test.||5|-10|0.27
70941374|NCT00694564|141383412|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation was calculated as this was a pilot study to determine such parameters.||||||0.004||95.0|||||MANOVA|||||||0.004
70928634|NCT04800211|141353080|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.403|||<|0.0001|TWO_SIDED|95.0|-4.005|-2.801|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.801|-4.005|<.0001
70928635|NCT04800211|141353080|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.747|||<|0.0001|TWO_SIDED|95.0|-4.473|-3.02|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-3.020|-4.473|<.0001
71011050|NCT01733758|141529032|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The second test in a sequential testing procedure starting with albiglutide 50 mg versus placebo, and if significant at 0.05 level, followed by albiglutide 30 mg versus placebo.|t-test, 2 sided|The p-value is from a 2-sided t-test to test whether the difference of LS means (albiglutide 30 mg - placebo) is equal to zero.||||||<0.0001
71011051|NCT04594213|141529087|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71011052|NCT04594213|141529088|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71011053|NCT04594213|141529089|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71011054|NCT04594213|141529090|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71011055|NCT04594213|141529091|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71011056|NCT04594213|141529092|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71011057|NCT04594213|141529093|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71011058|NCT04594213|141529094|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71011059|NCT04594213|141529095|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71011060|NCT04594213|141529096|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71011061|NCT04594213|141529097|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71011062|NCT04594213|141529097|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71011063|NCT04594213|141529098|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71011064|NCT04594213|141529098|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71011065|NCT04594213|141529099|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71011066|NCT04594213|141529100|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71011067|NCT04594213|141529100|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71011068|NCT00538434|141529103|SUPERIORITY_OR_OTHER||Adjusted mean difference|-52.78|STANDARD_ERROR_OF_MEAN|11.4|<|0.0001|TWO_SIDED|95.0|-75.24|-30.32|||ANCOVA|adjustment for stratification factor and for variable at Baseline||||-30.32|-75.24|< 0.0001
71011069|NCT00538434|141529103|SUPERIORITY_OR_OTHER||Adjusted mean difference|-73.03|STANDARD_ERROR_OF_MEAN|11.29|<|0.0001|TWO_SIDED|95.0|-95.28|-50.78|||ANCOVA|adjustment for stratification factor and for variable at Baseline||||-50.78|-95.28|< 0.0001
71011070|NCT00538434|141529103|SUPERIORITY_OR_OTHER||Adjusted mean difference|-64.69|STANDARD_ERROR_OF_MEAN|11.28|<|0.0001|TWO_SIDED|95.0|-86.93|-42.45|||ANCOVA|adjustment for stratification factor and for variable at Baseline||||-42.45|-86.93|< 0.0001
71011071|NCT00538434|141529104|SUPERIORITY_OR_OTHER|||||||0.0313|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0313
71011072|NCT00538434|141529104|SUPERIORITY_OR_OTHER|||||||0.5793|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.5793
71011073|NCT00538434|141529104|SUPERIORITY_OR_OTHER|||||||0.4905|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.4905
71011074|NCT00538434|141529105|SUPERIORITY_OR_OTHER|||||||0.0062|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0062
71011075|NCT00538434|141529105|SUPERIORITY_OR_OTHER|||||||0.0943|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0943
71011076|NCT00538434|141529105|SUPERIORITY_OR_OTHER|||||||0.2955|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.2955
71011077|NCT00538434|141529106|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.75|STANDARD_ERROR_OF_MEAN|6.48||0.4644|TWO_SIDED|95.0|-17.53|8.03||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Physical Summary Score||8.03|-17.53|0.4644
71011078|NCT00538434|141529106|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.47|STANDARD_ERROR_OF_MEAN|6.44||0.8196|TWO_SIDED|95.0|-14.17|11.23||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Physical Summary Score||11.23|-14.17|0.8196
71011079|NCT00538434|141529106|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.36|STANDARD_ERROR_OF_MEAN|6.36||0.8306|TWO_SIDED|95.0|-11.19|13.91||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Physical Summary Score||13.91|-11.19|0.8306
71046816|NCT01763918|141602333|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.41|STANDARD_ERROR_OF_MEAN|3.19|<|0.001|TWO_SIDED|95.0|-55.73|-43.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-43.10|-55.73|<0.001
71046817|NCT01763918|141602334|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-46.59|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|-51.43|-41.76||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-41.76|-51.43|<0.001
71046818|NCT01763918|141602334|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.16|STANDARD_ERROR_OF_MEAN|2.56|<|0.001|TWO_SIDED|95.0|-54.21|-44.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-44.11|-54.21|<0.001
71046819|NCT01763918|141602335|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-46.08|STANDARD_ERROR_OF_MEAN|2.63|<|0.001|TWO_SIDED|95.0|-51.27|-40.88||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-40.88|-51.27|<0.001
71046820|NCT01763918|141602335|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-45.42|STANDARD_ERROR_OF_MEAN|3.77|<|0.001|TWO_SIDED|95.0|-52.86|-37.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-37.98|-52.86|<0.001
71046821|NCT01763918|141602336|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-53.17|STANDARD_ERROR_OF_MEAN|2.62|<|0.001|TWO_SIDED|95.0|-58.35|-47.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-47.99|-58.35|<0.001
71046822|NCT01763918|141602336|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-55.56|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-61.08|-50.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-50.05|-61.08|<0.001
71046823|NCT01763918|141602337|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-54.28|STANDARD_ERROR_OF_MEAN|2.97|<|0.001|TWO_SIDED|95.0|-60.16|-48.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-48.41|-60.16|<0.001
71046824|NCT01763918|141602337|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.55|STANDARD_ERROR_OF_MEAN|4.35|<|0.001|TWO_SIDED|95.0|-58.14|-40.96||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-40.96|-58.14|<0.001
71046825|NCT01763918|141602338|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-31.37|STANDARD_ERROR_OF_MEAN|3.52|<|0.001|TWO_SIDED|95.0|-38.33|-24.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-24.41|-38.33|<0.001
70941375|NCT01284634|141383414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.89|STANDARD_ERROR_OF_MEAN|5.454||0.222|TWO_SIDED|90.0|-16.35|2.56|||Regression, Linear|||The EOT liver triglyceride levels were analyzed using a linear regression model, with EOT liver triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline liver triglyceride levels as a covariate, and gender as a factor.||2.56|-16.35|0.222
71046826|NCT01763918|141602338|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-31.0|STANDARD_ERROR_OF_MEAN|3.5|<|0.001|TWO_SIDED|95.0|-37.91|-24.09||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-24.09|-37.91|<0.001
71046827|NCT01763918|141602339|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-31.57|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|95.0|-39.28|-23.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-23.87|-39.28|<0.001
71046828|NCT01763918|141602339|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-28.24|STANDARD_ERROR_OF_MEAN|3.73|<|0.001|TWO_SIDED|95.0|-35.61|-20.88||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-20.88|-35.61|<0.001
71046829|NCT01763918|141602340|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-22.36|STANDARD_ERROR_OF_MEAN|3.6|<|0.001|TWO_SIDED|95.0|-29.48|-15.24||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-15.24|-29.48|<0.001
71046830|NCT01763918|141602340|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-16.74|STANDARD_ERROR_OF_MEAN|3.89|<|0.001|TWO_SIDED|95.0|-24.43|-9.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-9.05|-24.43|<0.001
71046831|NCT01763918|141602341|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-19.59|STANDARD_ERROR_OF_MEAN|4.22|<|0.001|TWO_SIDED|95.0|-27.92|-11.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-11.26|-27.92|<0.001
71046832|NCT01763918|141602341|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-11.56|STANDARD_ERROR_OF_MEAN|4.97|<|0.001|TWO_SIDED|95.0|-21.38|-1.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-1.74|-21.38|<0.001
71046833|NCT01763918|141602342|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|8.38|STANDARD_ERROR_OF_MEAN|2.04|<|0.001|TWO_SIDED|95.0|4.36|12.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||12.40|4.36|<0.001
71046834|NCT01763918|141602342|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|9.48|STANDARD_ERROR_OF_MEAN|2.21|<|0.001|TWO_SIDED|95.0|5.1|13.85||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||13.85|5.10|<0.001
71046835|NCT01763918|141602343|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|9.2|STANDARD_ERROR_OF_MEAN|2.3|<|0.001|TWO_SIDED|95.0|4.66|13.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||13.74|4.66|<0.001
71046836|NCT01763918|141602343|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|9.07|STANDARD_ERROR_OF_MEAN|2.83|<|0.001|TWO_SIDED|95.0|3.48|1466.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||1466|3.48|<0.001
71046837|NCT01763918|141602344|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-22.63|STANDARD_ERROR_OF_MEAN|3.46|<|0.001|TWO_SIDED|95.0|-29.46|-15.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-15.81|-29.46|<0.001
71046838|NCT01763918|141602344|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-15.54|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|95.0|-23.25|-7.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-7.84|-23.25|<0.001
71046839|NCT01763918|141602345|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-20.97|STANDARD_ERROR_OF_MEAN|4.21|<|0.001|TWO_SIDED|95.0|-29.29|-12.66||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-12.66|-29.29|<0.001
71046840|NCT01763918|141602345|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-9.17|STANDARD_ERROR_OF_MEAN|4.98|<|0.001|TWO_SIDED|95.0|-19.01|0.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||0.68|-19.01|<0.001
71046841|NCT03395639|141602346|OTHER|Difference in adjudicated major or CRNM bleeding rates were assessed.|Annualized rate difference|-0.03|||||TWO_SIDED|95.0|-0.18|0.12||||||||0.12|-0.18|
71046842|NCT03395639|141602346|OTHER|Difference in adjudicated major bleeding rates were assessed.|Annualized rate difference|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0|0|
71046843|NCT03395639|141602346|OTHER|Difference in all adjudicated bleeding (major, CRNM, minor) rates were assessed.|Annualized rate difference|0.0|||||TWO_SIDED|95.0|-0.24|0.25||||||||0.25|-0.24|
71046844|NCT00942331|141602354|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.1707|TWO_SIDED|95.0|0.72|1.06|||Log Rank|Stratified log rank||||1.06|0.72|0.1707
71077850|NCT02913105|141664397|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.739|TWO_SIDED|90.0|0.77|1.19|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 42||1.19|0.77|0.7390
71103764|NCT00721110|141715020|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.0||||0.28|TWO_SIDED|97.5|-15.0|5.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Lidocaine versus nonlidocaine on postoperative care unit opioid consumption was assessed using a Wilcoxon rank sum test.||5|-15|0.28
71103765|NCT00721110|141715020|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.0||||0.22|TWO_SIDED|97.5|-15.0|4.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Ketamine versus nonketamine on postoperative care unit opioid consumption was assessed using a Wilcoxon rank sum test.||4|-15|0.22
71046845|NCT01901874|141602407|OTHER|"Acceptable performance: favorably exclude PG=16.9% with 95.1% confidence.~Wa = expected weight (proportion) anatomic = 35% Pa = CEA expected anatomic MAE = 11% Wc = expected weight (proportion) comorbid = 65% Pc = CEA expected comorbid MAE = 14% D = noninferiority delta = 4%~PG = 0.35 x 11% + 0.65 x 14% + 4% = 16.9%"|Weighted binomial proportion|0.0448|STANDARD_ERROR_OF_MEAN|0.0241|<|1e-05|ONE_SIDED|95.1||0.0846||A priori 1-sided alpha = 0.049 (from simulation) to ensure overall type-1 error rate ≤ 0.05.|Binomial test (normal approximation)||Weighted by expected fractions of anatomic and comorbid high risk subjects (35% and 65%, respectively). Standard error based on H0.|"Test null hypothesis of equal or greater proportion with 1-year MAE compared to a performance goal (PG).~H0: P ≥ 16.9% vs H1: P \< 16.9%, where P is the true proportion of CAS subjects with 1-year MAE and 16.9% is the PG based on outcomes reported for patients treated with carotid endarterectomy (CEA).~N=280 subjects provide ≥90% power to exclude PG with 95.1% confidence if P=10.2% under H1."||0.0846||<0.00001
71046846|NCT01901874|141602415|OTHER||Cumulative probability|0.018|||||TWO_SIDED|95.0|0.007|0.047|||||Kaplan-Meier product-limit method (Greenwood's formula for standard error)|||0.047|0.007|
71046847|NCT01901874|141602416|OTHER||Cumulative probability|0.022|||||TWO_SIDED|95.0|0.009|0.052|||||Kaplan-Meier product-limit method (Greenwood's formula for standard error)|||0.052|0.009|
71046848|NCT04632706|141602421|OTHER|||||||0.803||||||If the p-value is more than 0.05 then dose proportionality can not be confirmed.|Mixed Models Analysis|||Assessment of dose proportionality on D2 and D28||||0.803
71046849|NCT04632706|141602423|OTHER|||||||0.689||||||If the p-value is more than 0.05 then dose proportionality can not be confirmed.|Mixed Models Analysis|||Assessment of dose proportionality on D2 and D28||||0.689
71046850|NCT03832738|141602426|SUPERIORITY||Odds Ratio (OR)|1.5||||0.558|TWO_SIDED|95.0|0.39|5.8||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||5.80|0.39|0.558
71046851|NCT03832738|141602426|SUPERIORITY||Odds Ratio (OR)|3.74||||0.035|TWO_SIDED|95.0|1.07|13.1||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||13.10|1.07|0.035
71046852|NCT03832738|141602427|SUPERIORITY||Odds Ratio (OR)|2.26||||0.086|TWO_SIDED|95.0|0.89|5.75||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||5.75|0.89|0.086
71011080|NCT00538434|141529106|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.38|STANDARD_ERROR_OF_MEAN|4.37||0.1459|TWO_SIDED|95.0|-15.01|2.24||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Psychosocial Summary Score||2.24|-15.01|0.1459
71046853|NCT03832738|141602427|SUPERIORITY||Odds Ratio (OR)|3.76||||0.006|TWO_SIDED|95.0|1.45|9.75||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||9.75|1.45|0.006
71046854|NCT03832738|141602428|SUPERIORITY||Odds Ratio (OR)|1.0|||>|0.999|TWO_SIDED|95.0|0.06|17.25||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||17.25|0.06|>0.999
71046855|NCT03832738|141602428|SUPERIORITY||Odds Ratio (OR)|3.86||||0.244|TWO_SIDED|95.0|0.36|41.2||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||41.20|0.36|0.244
71046856|NCT03832738|141602430|SUPERIORITY||Odds Ratio (OR)|5.21||||0.009|TWO_SIDED|95.0|1.38|19.62||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||19.62|1.38|0.009
71046857|NCT03832738|141602430|SUPERIORITY||Odds Ratio (OR)|7.35||||0.002|TWO_SIDED|95.0|1.86|29.08||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||29.08|1.86|0.002
71011081|NCT00538434|141529106|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.41|STANDARD_ERROR_OF_MEAN|4.38||0.4375|TWO_SIDED|95.0|-12.05|5.23||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Psychosocial Summary Score||5.23|-12.05|0.4375
71011082|NCT00538434|141529106|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.43|STANDARD_ERROR_OF_MEAN|4.35||0.9217|TWO_SIDED|95.0|-9.0|8.15||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Psychosocial Summary Score||8.15|-9.00|0.9217
71046858|NCT02025751|141602445|SUPERIORITY|||||||0.597|||||||ANCOVA|||||||0.597
71046859|NCT03864042|141602446|OTHER||Geometric LS Mean Ratio|1.17|||||TWO_SIDED|90.0|0.978|1.4|||||Day 1 / Day -7|||1.40|0.978|
71046860|NCT03864042|141602446|OTHER||Geometric LS Mean Ratio|0.258|||||TWO_SIDED|90.0|0.215|0.308|||||Day 14 / Day -7|||0.308|0.215|
71046861|NCT03864042|141602447|OTHER||Geometric LS Mean Ratio|1.12|||||TWO_SIDED|90.0|0.998|1.25|||||Day 1 / Day -7|||1.25|0.998|
71046862|NCT03864042|141602447|OTHER||Geometric LS Mean Ratio|1.25|||||TWO_SIDED|90.0|1.12|1.4|||||Day 14 / Day -7|||1.40|1.12|
71046863|NCT03864042|141602448|OTHER||Geometric LS Mean Ratio|1.34|||||TWO_SIDED|90.0|1.12|1.62|||||Day 1 / Day -7|||1.62|1.12|
71046864|NCT03864042|141602448|OTHER||Geometric LS Mean Ratio|0.622|||||TWO_SIDED|90.0|0.517|0.748|||||Day 14 / Day -7|||0.748|0.517|
71046865|NCT03864042|141602449|OTHER||Geometric LS Mean Ratio|1.09|||||TWO_SIDED|90.0|0.975|1.23|||||Day 1 / Day -7|||1.23|0.975|
71046866|NCT03864042|141602449|OTHER||Geometric LS Mean Ratio|1.3|||||TWO_SIDED|90.0|1.16|1.46|||||Day 14 / Day -7|||1.46|1.16|
71046867|NCT03864042|141602450|OTHER||Geometric LS Mean Ratio|1.05|||||TWO_SIDED|90.0|0.922|1.2|||||Day 1 / Day -7|||1.20|0.922|
71046868|NCT03864042|141602450|OTHER||Geometric LS Mean Ratio|1.13|||||TWO_SIDED|90.0|0.992|1.29|||||Day 14 / Day -7|||1.29|0.992|
71046869|NCT03864042|141602451|OTHER||Geometric LS Mean Ratio|1.09|||||TWO_SIDED|90.0|0.99|1.19|||||Day 1 / Day -7|||1.19|0.990|
71046870|NCT03864042|141602451|OTHER||Geometric LS Mean Ratio|1.1|||||TWO_SIDED|90.0|1.0|1.22|||||Day 14 / Day -7|||1.22|1.00|
71011083|NCT00538434|141529106|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.57|STANDARD_ERROR_OF_MEAN|7.82||0.8412|TWO_SIDED|95.0|-16.98|13.85||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Global Health Score||13.85|-16.98|0.8412
71011084|NCT00538434|141529106|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.54|STANDARD_ERROR_OF_MEAN|7.81||0.4794|TWO_SIDED|95.0|-20.94|9.87||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Global Health Score||9.87|-20.94|0.4794
71011085|NCT00538434|141529106|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.06|STANDARD_ERROR_OF_MEAN|7.66||0.8906|TWO_SIDED|95.0|-16.16|14.06||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Global Health Score||14.06|-16.16|0.8906
71011086|NCT03814499|141529111|OTHER||Coefficient|-2.3|||<|0.01|TWO_SIDED||||||Regression, Linear|||||||<0.01
71011087|NCT03814499|141529112|OTHER||Coefficient|-3.8|||<|0.01|TWO_SIDED||||||Regression, Linear|||||||<0.01
71011088|NCT03814499|141529113|OTHER||Coefficient|369.9||||0.3269|TWO_SIDED||||||Regression, Linear|||||||0.3269
71011089|NCT03814499|141529114|OTHER||Coefficient|365.4||||0.4265|TWO_SIDED||||||Regression, Linear|||||||0.4265
71011090|NCT03814499|141529115|OTHER||Coefficient|264.3||||0.4782|TWO_SIDED||||||Regression, Linear|||||||0.4782
71011091|NCT03814499|141529116|OTHER||Coefficient|730.2||||0.2716|TWO_SIDED||||||Regression, Linear|||||||0.2716
71011092|NCT03814499|141529117|OTHER||Coefficient|-0.6||||0.4178|TWO_SIDED||||||Regression, Linear|||||||0.4178
71011093|NCT03814499|141529118|OTHER||Coefficient|-1.5||||0.2677|TWO_SIDED||||||Regression, Linear|||||||0.2677
71011094|NCT03814499|141529119|OTHER||Coefficient|-467.0||||0.3364|TWO_SIDED||||||Regression, Linear|||||||0.3364
71011095|NCT03814499|141529120|OTHER||Coefficient|-908.0||||0.1124|TWO_SIDED||||||Regression, Linear|||||||0.1124
71011096|NCT03814499|141529121|OTHER||Coefficient|479.2||||0.2649|TWO_SIDED||||||Regression, Linear|||||||0.2649
71011097|NCT03814499|141529122|OTHER||Coefficient|1114.3||||0.216|TWO_SIDED||||||Regression, Linear|||||||0.216
71011098|NCT03814499|141529123|OTHER||Coefficient|0.1||||0.9032|TWO_SIDED||||||Regression, Linear|||||||0.9032
71011099|NCT03814499|141529124|OTHER||Coefficient|-0.4||||0.7889|TWO_SIDED||||||Regression, Linear|||||||0.7889
71011100|NCT03814499|141529125|OTHER||Coefficient|7.0||||0.0242|TWO_SIDED||||||Regression, Linear|||||||0.0242
71011101|NCT03814499|141529126|OTHER||Coefficient|1.5||||0.5092|TWO_SIDED||||||Regression, Linear|||||||0.5092
71011102|NCT03814499|141529127|OTHER||Coefficient|-47.1||||0.3634|TWO_SIDED||||||Regression, Linear|||||||0.3634
71011103|NCT03814499|141529128|OTHER||Coefficient|-204.7||||0.0677|TWO_SIDED||||||Regression, Linear|||||||0.0677
71011104|NCT03814499|141529129|OTHER||Coefficient|-235.8||||0.156|TWO_SIDED||||||Regression, Linear|||||||0.156
71011105|NCT03814499|141529130|OTHER||Coefficient|-102.0||||0.3148|TWO_SIDED||||||Regression, Linear|||||||0.3148
71011106|NCT03814499|141529131|OTHER||Coefficient|-0.1||||0.9349|TWO_SIDED||||||Regression, Linear|||||||0.9349
71011107|NCT03814499|141529132|OTHER||Coefficient|-0.6||||0.7196|TWO_SIDED||||||Regression, Linear|||||||0.7196
71046871|NCT03864042|141602452|OTHER||Geometric LS Mean Ratio|0.894|||||TWO_SIDED|90.0|0.741|1.08|||||Day 1 / Day -7|||1.08|0.741|
71011108|NCT03814499|141529133|OTHER||Coefficient|4.7||||0.0542|TWO_SIDED||||||Regression, Linear|||||||0.0542
71011109|NCT03814499|141529134|OTHER||Coefficient|2.6||||0.4224|TWO_SIDED||||||Regression, Linear|||||||0.4224
71011110|NCT03814499|141529135|OTHER||Coeffiient|-118.9||||0.1247|TWO_SIDED||||||Regression, Linear|||||||0.1247
71011111|NCT03814499|141529136|OTHER||Coefficient|-135.2||||0.1461|TWO_SIDED||||||Regression, Linear|||||||0.1461
71011112|NCT03814499|141529137|OTHER||Coefficient|-154.2||||0.0699|TWO_SIDED||||||Regression, Linear|||||||0.0699
71011113|NCT03814499|141529138|OTHER||Coefficient|-164.6||||0.0901|TWO_SIDED||||||Regression, Linear|||||||0.0901
71011114|NCT01589185|141529140|SUPERIORITY|||||||0.3962||||||\< 0.1 is considered borderline significant|Fisher Exact|||The number (%) of patients who died on or before end of study (EOS) was compared among all 5 groups. The mITT population was used.||||0.3962
71011115|NCT02046993|141529144|SUPERIORITY_OR_OTHER|||||||0.27|||||||Chi-squared|||comparison of the percentage of patients doing HBPM between intervention and control group at baseline||||0.27
71011116|NCT02046993|141529144|SUPERIORITY_OR_OTHER|||||||0.02|||||||McNemar|||Comparison of percentage of subjects doing HBPM at 3rd month from baseline within intervention group||||.020
71011117|NCT02046993|141529144|SUPERIORITY_OR_OTHER|||||||0.06|||||||McNemar|||comparison in percentage of patients doing Home BP monitoring at 6th month from baseline within intervention group||||.060
71011118|NCT02046993|141529144|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||McNemar|||Change in the proportion of patients doing HBPM at 3 months from baseline within the control group||||.002
71046872|NCT03864042|141602452|OTHER||Geometric LS Mean Ratio|0.692|||||TWO_SIDED|90.0|0.573|0.835|||||Day 14 / Day -7|||0.835|0.573|
71011119|NCT02046993|141529144|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||McNemar|||Change in proportion of patients doing HBPM at 6 months from baseline within control group||||.009
71011120|NCT02046993|141529145|SUPERIORITY_OR_OTHER|||||||0.813|||||||t-test, 2 sided|||Comparison of baseline mean clinic systolic BP mCSBP readings between control and intervention||||0.813
71011121|NCT02046993|141529145|SUPERIORITY_OR_OTHER|||||||0.865|||||||t-test, 2 sided|||Comparison of baseline mean clinic diastolic BP mCDBP readings between control and intervention||||0.865
71046873|NCT03864042|141602453|OTHER||Geometric LS Mean Ratio|1.32|||||TWO_SIDED|90.0|0.861|2.04|||||Day 1 / Day -7|||2.04|0.861|
71046874|NCT03864042|141602453|OTHER||Geometric LS Mean Ratio|1.01|||||TWO_SIDED|90.0|0.659|1.56|||||Day 14 / Day -7|||1.56|0.659|
71046875|NCT03864042|141602454|OTHER||Geometric LS Mean Ratio|1.01|||||TWO_SIDED|90.0|0.762|1.33|||||Day 1 / Day -7|||1.33|0.762|
71046876|NCT03864042|141602454|OTHER||Geometric LS Mean Ratio|0.718|||||TWO_SIDED|90.0|0.543|0.948|||||Day 14 / Day -7|||0.948|0.543|
70941376|NCT01284634|141383414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.35|STANDARD_ERROR_OF_MEAN|5.943||0.133|TWO_SIDED|90.0|-19.66|0.95|||Regression, Linear|||The EOT liver triglyceride levels were analyzed using a linear regression model, with EOT liver triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline liver triglyceride levels as a covariate, and gender as a factor.||0.95|-19.66|0.133
71011122|NCT02046993|141529145|SUPERIORITY_OR_OTHER|||||||0.476|||||||t-test, 2 sided|||Comparison of difference of mean clinic systolic BP readings mCSBP between control and intervention at 3 months from baseline||||0.476
71011123|NCT02046993|141529145|SUPERIORITY_OR_OTHER|||||||0.14|||||||t-test, 2 sided|||Comparison of difference of mean clinic diastolic BP mCDBP readings between control and intervention at 3 months from baseline||||0.14
71011124|NCT02046993|141529145|SUPERIORITY_OR_OTHER|||||||0.495|||||||t-test, 2 sided|||Comparison of difference of mean clinic systolic BP readings mCSBP between control and intervention at 6 months from baseline||||0.495
71011125|NCT02046993|141529145|SUPERIORITY_OR_OTHER|||||||0.967|||||||t-test, 2 sided|||Comparison of difference in mean clinic diastolic BP readings mCDBP between control and intervention at 6 months from baseline||||0.967
71011126|NCT02046993|141529146|SUPERIORITY_OR_OTHER|||||||0.819|||||||t-test, 2 sided|||Comparison of baselline SEMCD between telemonitoring group and enhanced usual care||||0.819
71011127|NCT02046993|141529146|SUPERIORITY_OR_OTHER|||||||0.512|||||||t-test, 2 sided|||Comparison of SEMCD at 3 months between telemonitoring group and enhanced usual care||||0.512
71011128|NCT02046993|141529146|SUPERIORITY_OR_OTHER|||||||0.325|||||||t-test, 2 sided|||Comparison of SEMCD at 6 months between telemonitoring group and enhanced usual care group||||0.325
71011129|NCT02046993|141529147|SUPERIORITY_OR_OTHER|||||||0.532|||||||t-test, 2 sided|||comparison of baseline mHSBP in mmHg between Telemonitoring and Enhanced Usual Care groups||||0.532
71011130|NCT02046993|141529147|SUPERIORITY_OR_OTHER|||||||0.902|||||||t-test, 2 sided|||comparison of baseline mHDBP in mmHg between Telemonitoring and Enhanced Usual Care groups||||0.902
71011131|NCT02046993|141529148|SUPERIORITY_OR_OTHER|||||||0.138|||||||t-test, 2 sided|||comparison of mHSBP at 3 months between smartphone based telemonitoring group and control group on enhanced usual care||||0.138
71011132|NCT02046993|141529148|SUPERIORITY_OR_OTHER|||||||0.204|||||||t-test, 2 sided|||comparison of mHDBP in mmHg between Telemonitoring and Enhanced Usual Care groups at 3 months||||0.204
71011133|NCT02046993|141529149|SUPERIORITY_OR_OTHER|||||||0.199|||||||t-test, 2 sided|||comparison of mHSBP in mmHg between Telemonitoring groups and Enhanced Usual Care groups at 6 months||||0.199
71011134|NCT02046993|141529149|SUPERIORITY_OR_OTHER|||||||0.204|||||||t-test, 2 sided|||comparison of mHDBP in mmHg at 6 months between Telemonitoring and Enhanced Usual Care groups||||0.204
71011135|NCT00598442|141529151|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 97.5% CI for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ -1.0 g/dL.|Least Squares Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.101|||TWO_SIDED|97.5|-0.09|0.36|||ANOVA|The ANOVA cell means model was used to estimate primary efficacy endpoint within the specified cells formed by the combination of treatment and strata||The sample size for this study was determined based on a two-group evaluation of non-inferiority in means with a non-inferiority margin (Δ) of -1.0 g/dL (one-sided significance level of 0.0125, or, comparably, a two-sided significance level of 0.025). A sample size of 450 (150 per treatment group) provided power greater than 99% for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a pooled standard deviation of 1.5 g/dL.||0.36|-0.09|
71046877|NCT03864042|141602455|OTHER||Geometric LS Mean Ratio|4.34|||||TWO_SIDED|90.0|2.94|6.4|||||Day 1 / Day -7|||6.40|2.94|
71046878|NCT03864042|141602455|OTHER||Geometric LS Mean Ratio|2.68|||||TWO_SIDED|90.0|1.82|3.96|||||Day 14 / Day -7|||3.96|1.82|
71046879|NCT03864042|141602456|OTHER||Geometric LS Mean Ratio|0.754|||||TWO_SIDED|90.0|0.595|0.954|||||Day 1 / Day -7|||0.954|0.595|
71046880|NCT03864042|141602456|OTHER||Geometric LS Mean Ratio|0.755|||||TWO_SIDED|90.0|0.596|0.957|||||Day 14 / Day -7|||0.957|0.596|
71046881|NCT03864042|141602457|OTHER||Geometric LS Mean Ratio|1.05|||||TWO_SIDED|90.0|0.864|1.27|||||Day 1 / Day -7|||1.27|0.864|
71046882|NCT03864042|141602457|OTHER||Geometric LS Mean Ratio|1.42|||||TWO_SIDED|90.0|1.17|1.72|||||Day 14 / Day -7|||1.72|1.17|
71046883|NCT03864042|141602458|OTHER||Geometric LS Mean Ratio|1.07|||||TWO_SIDED|90.0|0.92|1.25|||||Day 1 / Day -7|||1.25|0.920|
71046884|NCT03864042|141602458|OTHER||Geometric LS Mean Ratio|0.175|||||TWO_SIDED|90.0|0.151|0.204|||||Day 14 / Day -7|||0.204|0.151|
71046885|NCT03864042|141602459|OTHER||Geometric LS Mean Ratio|1.28|||||TWO_SIDED|90.0|1.18|1.38|||||Day 1 / Day -7|||1.38|1.18|
71046886|NCT03864042|141602459|OTHER||Geometric LS Mean Ratio|1.05|||||TWO_SIDED|90.0|0.974|1.14|||||Day 14 / Day -7|||1.14|0.974|
71046887|NCT03864042|141602460|OTHER||Geometric LS Mean Ratio|1.25|||||TWO_SIDED|90.0|1.09|1.43|||||Day 1 / Day -7|||1.43|1.09|
71046888|NCT03864042|141602460|OTHER||Geometric LS Mean Ratio|0.513|||||TWO_SIDED|90.0|0.449|0.587|||||Day 14 / Day -7|||0.587|0.449|
71046889|NCT03864042|141602461|OTHER||Geometric LS Mean Ratio|1.28|||||TWO_SIDED|90.0|1.17|1.39|||||Day 1 / Day -7|||1.39|1.17|
71046890|NCT03864042|141602461|OTHER||Geometric LS Mean Ratio|1.07|||||TWO_SIDED|90.0|0.979|1.16|||||Day 14 / Day -7|||1.16|0.979|
71046891|NCT03864042|141602462|OTHER||Geometric LS Mean Ratio|1.09|||||TWO_SIDED|90.0|0.947|1.26|||||Day 1 / Day -7|||1.26|0.947|
71046892|NCT03864042|141602462|OTHER||Geometric LS Mean Ratio|1.27|||||TWO_SIDED|90.0|1.1|1.46|||||Day 14 / Day -7|||1.46|1.10|
71046893|NCT03864042|141602463|OTHER||Geometric LS Mean Ratio|1.12|||||TWO_SIDED|90.0|1.02|1.23|||||Day 1 / Day -7|||1.23|1.02|
71046894|NCT03864042|141602463|OTHER||Geometric LS Mean Ratio|1.26|||||TWO_SIDED|90.0|1.14|1.38|||||Day 14 / Day -7|||1.38|1.14|
71046895|NCT03864042|141602464|OTHER||Geometric LS Mean Ratio|0.9|||||TWO_SIDED|90.0|0.721|1.12|||||Day 1 / Day -7|||1.12|0.721|
71046896|NCT03864042|141602464|OTHER||Geometric LS Mean Ratio|0.679|||||TWO_SIDED|90.0|0.544|0.848|||||Day 14 / Day -7|||0.848|0.544|
71046897|NCT03864042|141602465|OTHER||Geometric LS Mean Ratio|1.26|||||TWO_SIDED|90.0|0.8|1.98|||||Day 1 / Day -7|||1.98|0.800|
71046898|NCT03864042|141602465|OTHER||Geometric LS Mean Ratio|0.827|||||TWO_SIDED|90.0|0.526|1.3|||||Day 14 / Day -7|||1.30|0.526|
71046899|NCT03864042|141602466|OTHER||Geometric LS Mean Ratio|0.98|||||TWO_SIDED|90.0|0.688|1.39|||||Day 1 / Day -7|||1.39|0.688|
71046900|NCT03864042|141602466|OTHER||Geometric LS Mean Ratio|0.633|||||TWO_SIDED|90.0|0.445|0.9|||||Day 14 / Day -7|||0.900|0.445|
70928636|NCT04800211|141353080|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.74|||<|0.0001|TWO_SIDED|95.0|-4.461|-3.018|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-3.018|-4.461|<.0001
70941377|NCT01284634|141383414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.54|STANDARD_ERROR_OF_MEAN|6.158||0.302|TWO_SIDED|90.0|-17.22|4.14|||Regression, Linear|||The EOT liver triglyceride levels were analyzed using a linear regression model, with EOT liver triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline liver triglyceride levels as a covariate, and gender as a factor.||4.14|-17.22|0.302
71011136|NCT00598442|141529151|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 97.5% CI for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ -1.0 g/dL.|Least Squares Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.102|||TWO_SIDED|97.5|0.08|0.54|||ANOVA|The ANOVA cell means model was used to estimate primary efficacy endpoint within the specified cells formed by the combination of treatment and strata||The sample size for this study was determined based on a two-group evaluation of non-inferiority in means with a non-inferiority margin (Δ) of -1.0 g/dL (one-sided significance level of 0.0125, or, comparably, a two-sided significance level of 0.025). A sample size of 450 (150 per treatment group) provided power greater than 99% for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a pooled standard deviation of 1.5 g/dL.||0.54|0.08|
71011137|NCT00598442|141529152|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.28|||||TWO_SIDED|95.0|1.04|5.01|||Cochran-Mantel-Haenszel|||||5.01|1.04|
71011138|NCT00598442|141529152|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.1|||||TWO_SIDED|95.0|0.94|4.69|||Cochran-Mantel-Haenszel|||||4.69|0.94|
71011139|NCT00598442|141529153|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.9|1.01|||Cochran-Mantel-Haenszel|||||1.01|0.90|
71011140|NCT00598442|141529153|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.93|1.04|||Cochran-Mantel-Haenszel|||||1.04|0.93|
71011141|NCT01729559|141529160|NON_INFERIORITY_OR_EQUIVALENCE|A 10% noninferiority margin was selected based on a previous trial showing a difference in the incidence of DVT of 13% with the use of 30 mg of enoxaparin every 12 hours compared to 5,000 U of unfractionated heparin (UFH) every 12 hr. To achieve 90% power using an a priori margin of 10% with a one-sided alpha of 0.025, a total of 182 patients (91 in each arm) was required.|Risk Difference (RD)|6.5||||0.025|TWO_SIDED|95.0|-2.9|15.8||One-tailed test of the cumulative VTE incidence between treatment groups.|Chi-squared, Corrected||Unadjusted cumulative incidence values between the two treatment groups were subtracted to calculate the risk difference for VTE between groups. This difference was compared to the a priori 10% margin of difference using the 95% confidence interval.|Analysis was performed in a subset of patients who received at least one follow-up venous duplex ultrasound of the lower extremities.||15.8|-2.9|0.025
71011142|NCT01729559|141529160|NON_INFERIORITY_OR_EQUIVALENCE|A 10% noninferiority margin was selected based on these data showing a difference in the incidence of DVT of 13% with the use of 30 mg of enoxaparin every 12 hours compared to 5,000 U of UFH every 12 hours. To achieve 90% power using an a priori margin of 10% with a one-sided alpha of 0.025, a total of 182 patients (91 in each arm) was required. This analysis was performed in the entire sample.|Risk Difference (RD)|3.1||||0.025|TWO_SIDED|95.0|-1.6|7.7||One-tailed test of the cumulative VTE incidence between treatment groups.|Chi-squared, Corrected||Unadjusted cumulative incidence values between the two treatment groups were subtracted to calculate the risk difference for VTE between groups. This difference was compared to the a priori 10% margin of difference using the 95% confidence interval.|"Analysis was performed in the total sample of eligible patients and who received their assigned treatment (referred to as the randomized treated sample) ."||7.7|-1.6|0.025
71011143|NCT03764813|141529166|SUPERIORITY||||||<|0.0001|||||||Kruskal-Wallis|||Group comparison is carried out among HbF values grouped according to the transfusion regimen (only cord blood transfusions, only adult transfusions, both cord and adult transfusions).||||<0.0001
71011144|NCT03764813|141529167|SUPERIORITY||Median Difference (Final Values)|0.165|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71011145|NCT03764813|141529168|SUPERIORITY||Median Difference (Final Values)|0.537|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71011146|NCT03764813|141529169|SUPERIORITY||||||<|0.0001|||||||Kruskal-Wallis|||Group comparison is carried out among HbF values grouped according to the transfusion regimen (only cord blood transfusions, only adult transfusions, both cord and adult transfusions).||||<0.0001
71011147|NCT04646668|141529175|SUPERIORITY|Due to the pilot nature of the current study, formal power calculations were not conducted.||||||0.002|||||||ANOVA|||The null hypothesis is that there is no difference in nicotine delivery between cigarettes, e-cigarettes, and heat not burn after the standardized 10-puff bout. ANOVAs were conducted to detect differences between products for nicotine concentration at five minutes (immediately following 10-puff bout). The test was performed with a significance level of 0.05 (two-sided).||||0.002
71046901|NCT03864042|141602467|OTHER||Geometric LS Mean Ratio|2.79|||||TWO_SIDED|90.0|2.08|3.74|||||Day 1 / Day -7|||3.74|2.08|
71046902|NCT03864042|141602467|OTHER||Geometric LS Mean Ratio|1.57|||||TWO_SIDED|90.0|1.17|2.11|||||Day 14 / Day -7|||2.11|1.17|
71046903|NCT03864042|141602468|OTHER||Geometric LS Mean Ratio|0.769|||||TWO_SIDED|90.0|0.637|0.928|||||Day 1 / Day -7|||0.928|0.637|
71046904|NCT03864042|141602468|OTHER||Geometric LS Mean Ratio|0.736|||||TWO_SIDED|90.0|0.61|0.889|||||Day 14 / Day -7|||0.889|0.610|
71046905|NCT03864042|141602469|OTHER||Geometric LS Mean Ratio|0.993|||||TWO_SIDED|90.0|0.803|1.23|||||Day 1 / Day -7|||1.23|0.803|
71046906|NCT03864042|141602469|OTHER||Geometric LS Mean Ratio|1.48|||||TWO_SIDED|90.0|1.2|1.83|||||Day 14 / Day -7|||1.83|1.20|
71046907|NCT03864042|141602470|OTHER||Geometric LS Mean Ratio|1.45|||||TWO_SIDED|90.0|0.902|2.32|||||Day 1 / Day -7|||2.32|0.902|
71046908|NCT03864042|141602470|OTHER||Geometric LS Mean Ratio|1.18|||||TWO_SIDED|90.0|0.72|1.93|||||Day 14 / Day -7|||1.93|0.720|
71046909|NCT03864042|141602471|OTHER||Geometric LS Mean Ratio|1.47|||||TWO_SIDED|90.0|0.915|2.36|||||Day 1 / Day -7|||2.36|0.915|
71046910|NCT03864042|141602471|OTHER||Geometric LS Mean Ratio|0.851|||||TWO_SIDED|90.0|0.519|1.39|||||Day 14 / Day -7|||1.39|0.519|
71046911|NCT03864042|141602472|OTHER||Geometric LS Mean Ratio|1.2|||||TWO_SIDED|90.0|0.775|1.87|||||Day 1 / Day -7|||1.87|0.775|
71046912|NCT03864042|141602472|OTHER||Geometric LS Mean Ratio|0.94|||||TWO_SIDED|90.0|0.593|1.49|||||Day 14 / Day -7|||1.49|0.593|
71046913|NCT03864042|141602473|OTHER||Geometric LS Mean Ratio|1.18|||||TWO_SIDED|90.0|0.83|1.67|||||Day 1 / Day -7|||1.67|0.830|
71046914|NCT03864042|141602473|OTHER||Geometric LS Mean Ratio|0.979|||||TWO_SIDED|90.0|0.68|1.41|||||Day 14 / Day -7|||1.41|0.680|
71046915|NCT03864042|141602474|OTHER||Geometric LS Mean Ratio|0.798|||||TWO_SIDED|90.0|0.585|1.09|||||Day 21 / Day 14|||1.09|0.585|
71046916|NCT03864042|141602475|OTHER||Geometric LS Mean Ratio|1.02|||||TWO_SIDED|90.0|0.935|1.11|||||Day 21 / Day 14|||1.11|0.935|
71046917|NCT03864042|141602476|OTHER||Geometric LS Mean Ratio|0.762|||||TWO_SIDED|90.0|0.613|0.945|||||Day 21 / Day 14|||0.945|0.613|
71046918|NCT03864042|141602477|OTHER||Geometric LS Mean Ratio|1.06|||||TWO_SIDED|90.0|0.929|1.22|||||Day 21 / Day 14|||1.22|0.929|
71046919|NCT02220725|141602595|SUPERIORITY||Hodges-Lehman estimate of shift|-70.14|||<|0.0001|TWO_SIDED|95.0|-85.43|-65.91|||2-sided test exact Wilcoxon rank-sum tes|||||-65.91|-85.43|<0.0001
71046920|NCT02220725|141602595|SUPERIORITY||Hodges-Lehman estimate of shift|-51.87|||<|0.0001|TWO_SIDED|95.0|-57.95|-47.03|||2-sided test exact Wilcoxon rank-sum tes|||||-47.03|-57.95|<0.0001
71046921|NCT02220725|141602596|SUPERIORITY||Hodges-Lehman estimate of shift|-74.45|||<|0.0001|TWO_SIDED|95.0|-78.92|-64.45|||2-sided test exact Wilcoxon rank-sum tes|||||-64.45|-78.92|<0.0001
71046922|NCT02220725|141602598|SUPERIORITY||Hodges-Lehmann Estimate of Shift|-18.0|||<|0.0001|TWO_SIDED|95.0|-23.05|-12.73|||2-sided test exact Wilcoxon rank-sum tes|||||-12.73|-23.05|<0.0001
71046923|NCT02220725|141602599|SUPERIORITY||Hodges-Lehman estimate of shift|1142.66|||<|0.0001|TWO_SIDED|95.0|1006.1|1281.4|||2-sided test exact Wilcoxon rank-sum tes|||||1281.40|1006.10|<0.0001
71046924|NCT02220725|141602599|SUPERIORITY||Hodges-Lehman estimate of shift|1205.05|||<|0.0001|TWO_SIDED|95.0|1034.17|1400.79|||2-sided test exact Wilcoxon rank-sum tes|||||1400.79|1034.17|<0.0001
71046925|NCT01583218|141602655|SUPERIORITY||Relative Risk Reduction (RRR)|0.209||||0.038|TWO_SIDED|95.0|0.013|0.366|||Cochran-Mantel-Haenszel|||||0.366|0.013|0.038
71046926|NCT01583218|141602656|SUPERIORITY||Relative Risk Reduction (RRR)|0.216||||0.018|TWO_SIDED|95.0|0.041|0.359|||Cochran-Mantel-Haenszel|||||0.359|0.041|0.018
71046927|NCT01583218|141602657|SUPERIORITY||Relative Risk Reduction (RRR)|0.254||||0.003|TWO_SIDED|95.0|0.092|0.387|||Cochran-Mantel-Haenszel|||||0.387|0.092|0.003
71046928|NCT01583218|141602658|SUPERIORITY|||||||0.554|||||||Chi-squared|||||||0.554
71046929|NCT01583218|141602659|SUPERIORITY||Relative Risk Reduction (RRR)|0.326||||0.092|TWO_SIDED|95.0|-0.069|0.576|||Cochran-Mantel-Haenszel|||||0.576|-0.069|0.092
71046930|NCT01583218|141602660|SUPERIORITY||Relative Risk Reduction (RRR)|0.295||||0.11|TWO_SIDED|95.0|-0.085|0.542|||Cochran-Mantel-Haenszel|||||0.542|-0.085|0.11
71046931|NCT01583218|141602661|SUPERIORITY||Relative Risk Reduction (RRR)|0.358||||0.039|TWO_SIDED|95.0|0.02|0.58|||Cochran-Mantel-Haenszel|||||0.580|0.020|0.039
71046932|NCT00986453|141602662|SUPERIORITY_OR_OTHER|||||||0.4697||95.0|||||t-test, 2 sided|||||||0.4697
71046933|NCT00986453|141602663|SUPERIORITY_OR_OTHER|||||||0.147||95.0|||||t-test, 2 sided|||||||0.1470
71046934|NCT00986453|141602664|SUPERIORITY_OR_OTHER|||||||0.0428||95.0|||||t-test, 2 sided|||||||0.0428
71046935|NCT00986453|141602665|SUPERIORITY_OR_OTHER|||||||0.0776||95.0|||||t-test, 2 sided|||||||0.0776
71046936|NCT00986453|141602666|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||t-test, 2 sided|||||||0.0002
71046937|NCT03334721|141602691|SUPERIORITY|"Given the crossover design through which the data were collected, the statistical model also included a Visit (1 vs. 2) factor and a Visit by Treatment Condition interaction term. Analysis used Linear Mixed Modeling with Fixed Factors."|Test III Tests of Fixed Effects (F)|0.141||||0.711|TWO_SIDED|||||Treatment Condition Factor (0 = Placebo, 1 = Gabapentin)|Mixed Models Analysis|df = 1, 20.183|||"Given the crossover design through which the data were collected, the statistical model also included a Visit (1 vs. 2) factor and a Visit by Treatment Condition interaction term."|||0.711
71046938|NCT02287909|141602713|SUPERIORITY||least square mean difference|-6.9|||>|0.05|TWO_SIDED|985.0|-38.0|24.0|||ANCOVA|||||24|-38|>0.05
71046939|NCT00605865|141602748|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was complications. The null hypothesis is there is no difference between with and without complications in the participants of responders."||||<0.001
71046940|NCT00605865|141602749|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was concomitant drug. The null hypothesis is there is no difference between with and without concomitant drug in the participants of responders."||||0.039
71046941|NCT00605865|141602750|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was renal dysfunction. The null hypothesis is there is no difference between with and without renal dysfunction in the participants of responders."||||0.011
71046942|NCT00605865|141602751|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was past medical history of other illness. The null hypothesis is there is no difference between with and without past medical history of other illness in the participants of responders."||||0.010
71046943|NCT00605865|141602752|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was average daily dose. The null hypothesis is there is no difference of five types of average daily dose in the participants of responders."||||<0.001
71046944|NCT00605865|141602753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was suicidal ideation (including suicide attempt). The null hypothesis is there is no difference between with and without suicidal ideation(including suicide attempt) in the participants of responders."||||0.014
70941378|NCT02720081|141383425|SUPERIORITY||Difference in least squares means|-4.775||||0.352|TWO_SIDED|95.0|-14.92|5.37|||ANOVA|Terms for treatment, number of C alleles at the pre-specified SNP, and prior inhaled corticosteroid use.||||5.370|-14.92|0.352
71011148|NCT02898662|141529183|OTHER|The null hypothesis was that during the 52-week double-blind treatment period, the time to LOAC in the AZD1419 arm was equal to the corresponding time to LOAC in the placebo arm.|Hazard Ratio (HR)|1.05||||0.5722|TWO_SIDED|95.0|0.59|1.87||1-sided p-value|Regression, Cox||Hazard ratio \< 1 favours AZD1419 over placebo.|Comparison between groups for time to LOAC. Cox regression model analysis with age and gender included as covariates.||1.87|0.59|0.5722
71011149|NCT02898662|141529184|OTHER||Odds Ratio (OR)|1.86||||0.2006|TWO_SIDED|95.0|0.72|4.79||2-sided p-value|Generalized estimating equation analysis|||Comparison between groups for participants experiencing LOAC. Odds ratio was estimated using a generalized linear model based on a generalized estimating equation approach fitting treatment, visit and age and gender as covariates.||4.79|0.72|0.2006
71011150|NCT02898662|141529185|OTHER||LS Mean difference|-0.02||||0.8166|TWO_SIDED|95.0|-0.22|0.17||2-sided p-value|Repeated measures analysis|||Comparison between groups for ACQ-5 score. Repeated measures analysis.||0.17|-0.22|0.8166
71011151|NCT02898662|141529186|OTHER||LS Mean difference|-0.03||||0.8412|TWO_SIDED|95.0|-0.32|0.26||2-sided p-value|Repeated measures analysis|||Comparison between groups for asthma daily diary score. Repeated measures analysis.||0.26|-0.32|0.8412
71011152|NCT02898662|141529187|OTHER|The null hypothesis was that the time to moderate or severe exacerbation was not different between AZD1419 and placebo.|Hazard Ratio (HR)|0.8||||0.5477|TWO_SIDED|95.0|0.38|1.67||2-sided p-value|Regression, Cox||Hazard ratio \< 1 favours AZD1419 over placebo.|Comparison between groups for time to moderate or severe asthma exacerbation. Cox regression model analysis with age and gender included as covariates.||1.67|0.38|0.5477
71011153|NCT02898662|141529187|OTHER||Odds Ratio (OR)|0.88||||0.7294|TWO_SIDED|95.0|0.41|1.86||2-sided p-value|Generalized estimating equation analysis|||Comparison between groups for participants with moderate or severe asthma exacerbation. Odds ratio was estimated using a generalized linear model based on a generalized estimating equation approach fitting treatment and visit as covariates.||1.86|0.41|0.7294
71011154|NCT02898662|141529189|OTHER||LS Mean difference|0.06||||0.3764|TWO_SIDED|95.0|-0.08|0.2||2-sided p-value|Repeated measures analysis|||Comparison between groups for pre-BD FEV1. Repeated measures analysis.||0.20|-0.08|0.3764
71011155|NCT02898662|141529189|OTHER||LS Mean difference|-0.03||||0.7013|TWO_SIDED|95.0|-0.17|0.11||2-sided p-value|Repeated measures analysis|||Comparison between groups for post-BD FEV1. Repeated measures analysis.||0.11|-0.17|0.7013
71011156|NCT02898662|141529190|OTHER||LS Mean difference|-0.32||||0.9686|TWO_SIDED|95.0|-16.54|15.9||2-sided p-value|Repeated measures analysis|||Comparison between groups for PEF. Repeated measures analysis.||15.90|-16.54|0.9686
71011157|NCT02898662|141529191|OTHER||LS Mean difference|-2.02||||0.5403|TWO_SIDED|95.0|-8.55|4.52||2-sided p-value|Repeated measures analysis|||Comparison between groups for FeNO. Repeated measures analysis.||4.52|-8.55|0.5403
71011158|NCT03432819|141529208|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Net)|9.24||||0.06|TWO_SIDED|95.0|-0.55|19.03|||Regression, Linear|||||19.03|-0.55|0.06
71046945|NCT00605865|141602754|SUPERIORITY_OR_OTHER_LEGACY|||||||0.021|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was 15 years and higher of age or not. The null hypothesis is there is no difference between 15 years and higher of age or not in the participants of responders."||||0.021
71011159|NCT03432819|141529209|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Final Values)|4.5||||0.02|TWO_SIDED|95.0|0.7|8.3|||Regression, Linear|||||8.30|0.70|0.02
71011160|NCT03432819|141529210|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Final Values)|0.08||||0.39|TWO_SIDED|95.0|-0.1|0.26|||Regression, Linear|||||0.26|-0.10|0.39
71011161|NCT03432819|141529211|SUPERIORITY||Median Difference (Final Values)|-0.09||||0.54|TWO_SIDED|95.0|-0.37|0.2|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||0.20|-0.37|0.54
71011162|NCT03432819|141529212|SUPERIORITY||Median Difference (Final Values)|-0.02||||0.81|TWO_SIDED|95.0|-0.18|0.14|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||0.14|-0.18|0.81
71046946|NCT00605865|141602755|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was target disease severity. The null hypothesis is there is no difference between three grade of target disease severity in the participants of responders."||||<0.001
70941379|NCT02720081|141383426|OTHER||Difference in percentages|-0.4|||||TWO_SIDED|95.0|-15.0|14.3|||||Based on Miettinen \& Nurminen|||14.3|-15.0|
70928637|NCT04800211|141353080|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.197|||<|0.0001|TWO_SIDED|95.0|-3.784|-2.61|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.610|-3.784|<.0001
70928638|NCT04800211|141353080|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.3|||<|0.0001|TWO_SIDED|95.0|-3.678|-2.921|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.921|-3.678|<.0001
70928639|NCT04800211|141353080|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-0.206||||0.348|TWO_SIDED|95.0|-0.638|0.226|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||0.226|-0.638|0.3480
70928640|NCT04800211|141353081|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 5. (mITT Population)|Mean Difference (Net)|-0.716|||<|0.0001|TWO_SIDED|95.0|-0.951|-0.481|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 5. (mITT Population)||-0.481|-0.951|<0.0001
70928641|NCT04800211|141353081|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 7. (mITT Population)|Mean Difference (Net)|-0.686|||<|0.0001|TWO_SIDED|95.0|-0.966|-0.406|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 7. (mITT Population)||-0.406|-0.966|<0.0001
70941380|NCT02720081|141383427|OTHER||Difference in percentages|-4.3|||||TWO_SIDED|95.0|-12.1|1.0|||||Based on Miettinen \& Nurminen|||1.0|-12.1|
70941381|NCT02720081|141383449|SUPERIORITY||Difference in least squares means|0.107||||0.023|TWO_SIDED|95.0|0.015|0.199|||Constrained longitudinal data analysis|Terms for treatment, time, interaction of time by treatment, number of C alleles at the pre-specified SNP, and prior inhaled corticosteroid use.||||0.199|0.015|0.023
71011163|NCT03432819|141529213|SUPERIORITY||Median Difference (Final Values)|-0.18||||0.06|TWO_SIDED|95.0|-0.37|0.01|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||0.01|-0.37|0.06
71011164|NCT03432819|141529214|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.16|TWO_SIDED|95.0|-0.78|0.13|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||0.13|-0.78|0.16
71046947|NCT00605865|141602756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was history of treatment prior to Sertralin. The null hypothesis is there is no difference between with and without history of treatment prior to Sertralin in the participants of responders."||||0.003
70941382|NCT03334747|141383472|OTHER|||||||0.391|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||0.391
71046948|NCT00605865|141602757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was outpatient or inpatient. The null hypothesis is there is no difference between outpatient or inpatient in the participants of responders."||||0.012
71046949|NCT00605865|141602758|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was complications. The null hypothesis is there is no difference between with or without complications in the participants of responders."||||0.019
71046950|NCT00605865|141602759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was 15 years and higher of age or not. The null hypothesis is there is no difference between 15 years and higher of age or not in the participants of responders."||||0.010
71046951|NCT00605865|141602760|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was age. The null hypothesis is there is no difference between four groups of age in the participants of responders."||||0.015
71046952|NCT00605865|141602761|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was suicidal ideation (including suicide attempt). The null hypothesis is there is no difference between with or without suicidal ideation (including suicide attempt) in the participants of responders."||||<0.001
71046953|NCT01032018|141602814|SUPERIORITY_OR_OTHER||Difference of back-transformed means.|-3.5||||0.01||95.0|-6.1|-0.7|||Mixed Models Analysis|||The trial was powered to detect a between-group difference in the 6-month change in depression symptoms. Assuming 5% attrition rate, we estimated that a sample of 150 patients would be needed to have 80% power to detect a clinically meaningful differential change in depression scores between groups of 0.46 SD.||-0.7|-6.1|0.01
71046954|NCT02130583|141602816|SUPERIORITY||Mean Difference (Net)|2.06||||0.034|TWO_SIDED||||||ANOVA|||||||.034
71046955|NCT02119286|141602823|SUPERIORITY_OR_OTHER||Least squared mean difference|0.122|||<|0.001|TWO_SIDED|95.0|0.091|0.152|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.152|0.091|<0.001
71046956|NCT02119286|141602823|SUPERIORITY_OR_OTHER||Least squared mean difference|0.111|||<|0.001|TWO_SIDED|95.0|0.081|0.141|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.141|0.081|<0.001
71046957|NCT02119286|141602824|SUPERIORITY_OR_OTHER||Least squared mean difference|0.147|||<|0.001|TWO_SIDED|95.0|0.114|0.179|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.179|0.114|<0.001
71046958|NCT02119286|141602824|SUPERIORITY_OR_OTHER||Least squared mean difference|0.135|||<|0.001|TWO_SIDED|95.0|0.103|0.167|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.167|0.103|<0.001
71046959|NCT03247517|141602825|SUPERIORITY||Least Square Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.98||0.0232|TWO_SIDED|95.0|-8.4|-0.6|||Mixed Models for Repeated Measures|||||-0.6|-8.4|0.0232
71046960|NCT03247517|141602825|SUPERIORITY||Least Square Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|1.93||0.0091|TWO_SIDED|95.0|-8.9|-1.3|||Mixed Models for Repeated Measures|||||-1.3|-8.9|0.0091
71046961|NCT03247517|141602826|SUPERIORITY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.0042|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.2|-0.8|0.0042
71046962|NCT03247517|141602826|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.16||0.0003|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.3|-0.9|0.0003
71046963|NCT03247517|141602827|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|1.54||0.6854|TWO_SIDED|95.0|-3.6|2.4|||ANCOVA|||||2.4|-3.6|0.6854
71046964|NCT03247517|141602827|SUPERIORITY||Least Square Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|1.49||0.0518|TWO_SIDED|95.0|-5.8|0.0|||ANCOVA|||||0.0|-5.8|0.0518
70941383|NCT03334747|141383472|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
70941384|NCT03334747|141383472|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
71046965|NCT03247517|141602828|SUPERIORITY||Least Square Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.061||0.2062|TWO_SIDED|95.0|-0.2|0.04|||ANCOVA|||||0.04|-0.20|0.2062
71046966|NCT03247517|141602828|SUPERIORITY||Least Square Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.059||0.0519|TWO_SIDED|95.0|-0.23|0.0|||ANCOVA|||||0.00|-0.23|0.0519
71046967|NCT03247517|141602829|SUPERIORITY||Risk Difference (RD)|18.8||||0.0068|TWO_SIDED|95.0|5.5|32.2|||Regression, Logistic|||||32.2|5.5|0.0068
71046968|NCT03247517|141602829|SUPERIORITY||Risk Difference (RD)|17.6||||0.0095|TWO_SIDED|95.0|4.6|30.5|||Regression, Logistic|||||30.5|4.6|0.0095
71046969|NCT03247517|141602830|SUPERIORITY||Least Square Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|5.51||0.7629|TWO_SIDED|95.0|-9.1|12.5|||ANCOVA|||||12.5|-9.1|0.7629
71046970|NCT03247517|141602830|SUPERIORITY||Least Square Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|5.36||0.7648|TWO_SIDED|95.0|-12.1|8.9|||ANCOVA|||||8.9|-12.1|0.7648
71046971|NCT03247517|141602831|SUPERIORITY||Least Square Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|0.99||0.0069|TWO_SIDED|95.0|-4.6|-0.7|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-0.7|-4.6|0.0069
71046972|NCT03247517|141602831|SUPERIORITY||Least Square Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.96||0.0005|TWO_SIDED|95.0|-5.2|-1.5|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-1.5|-5.2|0.0005
71046973|NCT03247517|141602831|SUPERIORITY||Least Square Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|1.05||0.0424|TWO_SIDED|95.0|-4.2|-0.1|||ANCOVA|||This analysis pertains to the Inattention subscale score||-0.1|-4.2|0.0424
71046974|NCT03247517|141602831|SUPERIORITY||Least Square Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|1.03||0.039|TWO_SIDED|95.0|-4.1|-0.1|||ANCOVA|||This analysis pertains to the Inattention subscale score||-0.1|-4.1|0.0390
71046975|NCT03247517|141602832|SUPERIORITY||Least Square Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.2||0.3813|TWO_SIDED|95.0|-3.4|1.3|||ANCOVA|||||1.3|-3.4|0.3813
71046976|NCT03247517|141602832|SUPERIORITY||Least Square Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.17||0.9506|TWO_SIDED|95.0|-2.4|2.2|||ANCOVA|||||2.2|-2.4|0.9506
70928642|NCT04800211|141353081|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 5. (mITT Population)|Mean Difference (Net)|-0.521|||<|0.0001|TWO_SIDED|95.0|-0.755|-0.288|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 5. (mITT Population)||-0.288|-0.755|<.0001
70928643|NCT04800211|141353081|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 7. (mITT Population)|Mean Difference (Net)|-0.342||||0.0131|TWO_SIDED|95.0|-0.612|-0.072|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 7. (mITT Population)||-0.072|-0.612|0.0131
70941385|NCT03334747|141383472|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
71011165|NCT03432819|141529215|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.02|TWO_SIDED|95.0|-0.84|-0.09|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||-0.09|-0.84|0.02
71011166|NCT03432819|141529216|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.71|TWO_SIDED|95.0|-0.32|0.47|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||0.47|-0.32|0.71
71011167|NCT03432819|141529217|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.1|TWO_SIDED|95.0|-0.73|0.06|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||0.06|-0.73|0.10
71011168|NCT03223649|141529261|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.035||0.005|TWO_SIDED|95.0|-0.17|-0.03||Unadjusted p-value|ANCOVA|Log-transformed value adjusted for: arcsine sqrt transformed % fat mass, pubertal stage (pre, early, or late), and basal analyte log transformed.||||-.03|-.17|0.005
71011169|NCT03223649|141529262|SUPERIORITY||Mean Difference (Final Values)|-0.011|STANDARD_ERROR_OF_MEAN|0.011||0.349|TWO_SIDED|95.0|-0.033|0.011||Unadjusted P-value|ANCOVA|Log-transformed value adjusted for: arcsine sqrt transformed % fat mass, pubertal stage (pre, early, or late), and basal analyte log transformed.||||0.011|-.033|0.349
71011170|NCT03223649|141529263|SUPERIORITY||Mean Difference (Final Values)|-0.043|STANDARD_ERROR_OF_MEAN|0.021||0.045|TWO_SIDED|95.0|-0.084|-0.002||Unadjusted p-value|ANCOVA|Log-transformed value adjusted for: arcsine sqrt transformed % fat mass, pubertal stage (pre, early, or late), and basal analyte log transformed.||||-.002|-.084|.045
71011171|NCT03223649|141529264|SUPERIORITY||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.016||0.226|TWO_SIDED|95.0|-0.051|0.013||Unadjusted p-value|ANCOVA|Log-transformed value adjusted for: arcsine sqrt transformed % fat mass, pubertal stage (pre, early, or late), and basal analyte log transformed.||||0.013|-0.051|0.226
71046977|NCT03247517|141602833|SUPERIORITY|||||||0.0254|||||||Chi-squared|||This analysis pertains to Week 1||||0.0254
71046978|NCT03247517|141602833|SUPERIORITY|||||||0.0899|||||||Chi-squared|||This analysis pertains to Week 2||||0.0899
71011172|NCT03223649|141529265|SUPERIORITY||Mean Difference (Final Values)|-5.8|STANDARD_ERROR_OF_MEAN|0.545|<|0.001|TWO_SIDED|95.0|-6.884|-4.716|||t-test, 2 sided|||||-4.716|-6.884|<0.001
71011173|NCT03223649|141529266|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.116||0.39|TWO_SIDED|95.0|-0.33|0.13|||t-test, 2 sided|||||0.130|-0.330|0.39
71011174|NCT03223649|141529267|SUPERIORITY||Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.046||0.648|TWO_SIDED|95.0|-0.071|0.114|||ANCOVA|Dependent variable in Kcal log transformed, comparison adjusted for: age(y), lean mass(kg), fat mass(kg)||||0.114|-0.071|0.648
71011175|NCT03223649|141529268|SUPERIORITY||Mean Difference (Final Values)|0.834|STANDARD_ERROR_OF_MEAN|1.354||0.539|TWO_SIDED|95.0|-1.857|3.525|||ANCOVA|Adjusted for age (years)||||3.525|-1.857|0.539
71011176|NCT03223649|141529269|SUPERIORITY||Mean Difference (Final Values)|-1.06|STANDARD_ERROR_OF_MEAN|1.766||0.55|TWO_SIDED|95.0|-4.57|2.45|||ANCOVA|Adjusted for age (years)||||2.45|-4.57|0.550
71011177|NCT03223649|141529270|SUPERIORITY||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.681||0.741|TWO_SIDED|95.0|-1.127|1.579|||ANCOVA|Adjusted for age (years)||||1.579|-1.127|0.741
71011178|NCT03970330|141529274|SUPERIORITY||Mean Difference (Final Values)|1123.0||||0.2|TWO_SIDED|95.0|-755.0|3000.0|||t-test, 2 sided||Difference calculated as Naltrexone minus Placebo|||3000|-755|0.20
71046979|NCT03247517|141602833|SUPERIORITY|||||||0.007|||||||Chi-squared|||This analysis pertains to Week 3||||0.0070
71046980|NCT03247517|141602833|SUPERIORITY|||||||0.0031|||||||Chi-squared|||This analysis pertains to Week 4||||0.0031
71046981|NCT03247517|141602833|SUPERIORITY|||||||0.0065|||||||Chi-squared|||This analysis pertains to Week 5||||0.0065
71046982|NCT03247517|141602833|SUPERIORITY|||||||0.007|||||||Chi-squared|||This analysis pertains to Week 6||||0.0070
71046983|NCT03247517|141602833|SUPERIORITY|||||||0.0063|||||||Chi-squared|||This analysis pertains to Week 1||||0.0063
71046984|NCT03247517|141602833|SUPERIORITY|||||||0.0123|||||||Chi-squared|||This analysis pertains to Week 2||||0.0123
71046985|NCT03247517|141602833|SUPERIORITY|||||||0.0003|||||||Chi-squared|||This analysis pertains to Week 3||||0.0003
71046986|NCT03247517|141602833|SUPERIORITY|||||||0.0001|||||||Chi-squared|||This analysis pertains to Week 4||||0.0001
71046987|NCT03247517|141602833|SUPERIORITY|||||||0.0025|||||||Chi-squared|||This analysis pertains to Week 5||||0.0025
71046988|NCT03247517|141602833|SUPERIORITY|||||||0.0033|||||||Chi-squared|||This analysis pertains to Week 6||||0.0033
71046989|NCT03265288|141602847|SUPERIORITY||Least square means difference|0.7716||||0.3449|TWO_SIDED|95.0|-0.8397|2.3828||alpha is set to 0.05|Mixed Model for Repeated Measures||A positive difference favours LAU-7b, a negative difference favours placebo.|Primary analysis of the treatment effect at the Week 24 visit on the intent to treat population (ITT) Null hypothesis is no treatment difference||2.3828|-0.8397|0.3449
71046990|NCT03265288|141602847|SUPERIORITY||Least square means difference|1.0053||||0.0667|TWO_SIDED|95.0|-0.07|2.0807||alpha is set to 0.05|Mixed Model for Repeated Measures||A positive difference favours LAU-7b, a negative difference favours placebo.|Analysis of the overall treatment effect from baseline through Week 24 in the intent to treat population (ITT), Null hypothesis is no treatment difference||2.0807|-0.0700|0.0667
71046991|NCT03265288|141602847|SUPERIORITY||Least square means difference|1.2258||||0.0486|TWO_SIDED|95.0|0.0078|2.4438||alpha is set to 0.05|Mixed Model for Repeated Measures||A positive difference favours LAU-7b, a negative difference favours placebo.|Secondary analysis of the overall treatment effect from baseline through Week 24 on the per protocol population (PP), null hypothesis is no treatment difference||2.4438|0.0078|0.0486
71046992|NCT03265288|141602847|SUPERIORITY||Least square means difference|2.6628||||0.0687|TWO_SIDED|95.0|-0.2069|5.5325||alpha is set to 0.05|Mixed Model for Repeated Measures||A positive difference favours LAU-7b, a negative difference favours placebo.|"Secondary analysis of treatment effect at the Week 24 visit for stratification factor ppFEV1 (\<70% or ≥70%) in intent to treat population (ITT), null hypothesis is no treatment difference.~Here presented is the analysis for subgroup ≥70%, n=29 (LAU-7b), n=27 (Placebo)"||5.5325|-0.2069|0.0687
71046993|NCT03265288|141602847|SUPERIORITY||Least square means difference|1.391||||0.236|TWO_SIDED|95.0|-0.922|3.7041||alpha is set to 0.05|Mixed Model for Repeated Measures||A positive difference favours LAU-7b, a negative difference favours placebo.|"Secondary analysis of treatment effect at the Week 24 visit for stratification factor co-administration of CFTR modulator (yes/no) in intent to treat population (ITT), null hypothesis is no treatment difference.~Here presented is the analysis for subgroup receiving CFTR modulators, n=41 (LAU-7b), n=46 (Placebo)"||3.7041|-0.9220|0.236
70928644|NCT04800211|141353081|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to zero on Visit 7. (mITT Population)|Mean Difference (Net)|-0.514|||<|0.0001|TWO_SIDED|95.0|-0.712|-0.316|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to zero on Visit 7. (mITT Population)||-0.316|-0.712|<.0001
71046994|NCT03265288|141602847|SUPERIORITY||Least square means difference|1.1302||||0.5323|TWO_SIDED|95.0|-2.4447|4.7052||alpha is set to 0.05|Mixed Model for Repeated Measures||A positive difference favours LAU-7b, a negative difference favours placebo.|"Secondary analysis of treatment effect at the Week 24 visit for à priori defined subgroup co-administration of ETI - elexacaftor/tezacaftor/ivacaftor (yes/no) in intent to treat population (ITT), null hypothesis is no treatment difference.~Here presented is the analysis for subgroup receiving ETI, n=18 (LAU-7b), n=23 (Placebo)"||4.7052|-2.4447|0.5323
71046995|NCT03265288|141602849|SUPERIORITY||Odds Ratio (OR)|0.5036||||0.1047|TWO_SIDED|95.0|0.2199|1.1532||alpha is set to 0.05|Regression, Logistic||Odds ratio \< 1 means lower odds of normalization with LAU-7b, odds ratio \> 1 means higher odds of normalization with LAU-7b|Highest normalization of Arachidonic Acid (AA) during treatment Intent to treat population (ITT), null hypothesis is no treatment effect||1.1532|0.2199|0.1047
71046996|NCT03265288|141602849|SUPERIORITY||Odds Ratio (OR)|0.8773||||0.7596|TWO_SIDED|95.0|0.3793|2.0291||alpha is set to 0.05|Regression, Logistic||Odds ratio \< 1 means lower odds of normalization with LAU-7b, odds ratio \> 1 means higher odds of normalization with LAU-7b|Highest normalization of Docosahexaenoic Acid (DHA) during treatment Intent to treat population (ITT, null hypothesis is no treatment effect||2.0291|0.3793|0.7596
71046997|NCT03265288|141602849|SUPERIORITY||Odds Ratio (OR)|1.0532||||0.8852|TWO_SIDED|95.0|0.5209|2.1296||alpha is set to 0.05|Regression, Logistic||Odds ratio \< 1 means lower odds of normalization with LAU-7b, odds ratio \> 1 means higher odds of normalization with LAU-7b|Highest normalization of AA/DHA ratio during treatment Intent to treat population (ITT), null hypothesis is no treatment effect||2.1296|0.5209|0.8852
71046998|NCT03265288|141602852|SUPERIORITY|||||||0.3025|||||||Log Rank|||||||0.3025
71046999|NCT03265288|141602853|SUPERIORITY||Risk Ratio (RR)|1.55||||0.3366|TWO_SIDED|95.0|0.63|3.8||alpha is set to 0.05|Regression, Cox||Odds ratio \< 1 means lower odds of a pulmonary exacerbation with LAU-7b, odds ratio close to 1 means similar odds of a pulmonary exacerbation for LAU-7b and placebo, odds ratio \> 1 means higher odds of a pulmonary exacerbation with LAU-7b|Protocol-Defined IV antibiotics-treated pulmonary exacerbation events. Intent to treat population (ITT), null hypothesis is no treatment effect||3.80|0.63|0.3366
71047000|NCT03265288|141602853|OTHER||Risk Ratio (RR)|1.34||||0.3936|TWO_SIDED|95.0|0.68|2.64||alpha is set to 0.05|Regression, Cox||Odds ratio \< 1 means lower odds of a pulmonary exacerbation with LAU-7b, odds ratio close to 1 means similar odds of a pulmonary exacerbation for LAU-7b and placebo, odds ratio \> 1 means higher odds of a pulmonary exacerbation with LAU-7b|ALL IV antibiotics-treated pulmonary exacerbation events. Intent to treat population (ITT), null hypothesis is no treatment effect||2.64|0.68|0.3936
71047001|NCT03265288|141602853|SUPERIORITY||Risk Ratio (RR)|1.16||||0.5011|TWO_SIDED|95.0|0.75|1.79||alpha is set to 0.05|Regression, Cox||Odds ratio \< 1 means lower odds of a pulmonary exacerbation with LAU-7b, odds ratio close to 1 means similar odds of a pulmonary exacerbation for LAU-7b and placebo, odds ratio \> 1 means higher odds of a pulmonary exacerbation with LAU-7b|Combined IV- or Oral antibiotics-treated pulmonary exacerbation events. Intent to treat population (ITT), null hypothesis is no treatment effect||1.79|0.75|0.5011
71047002|NCT03265288|141602854|SUPERIORITY|||||||0.1955|||||||Log Rank|||||||0.1955
71047003|NCT03265288|141602855|SUPERIORITY||Risk Ratio (RR)|1.35||||0.1909|TWO_SIDED|95.0|0.86|2.12||alpha is set to 0.05|Poisson regression||Odds ratio \< 1 means lower odds of an antibiotic treatment with LAU-7b, odds ratio \> 1 means higher odds of an antibiotic treatment with LAU-7b|Number per subject of intravenous antibiotic treatments required for a pulmonary exacerbation, excludes Cycle 1 pulmonary exacerbations Intent to treat population (ITT), null hypothesis is no treatment effect||2.12|0.86|0.1909
70928645|NCT04800211|141353081|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 5. (mITT Population)|Mean Difference (Net)|-0.231||||0.0435|TWO_SIDED|95.0|-0.455|-0.007|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 5. (mITT Population)||-0.007|-0.455|0.0435
71047004|NCT03265288|141602856|SUPERIORITY||Risk Ratio (RR)|1.11||||0.7473|TWO_SIDED|95.0|0.6|2.04||alpha is set to 0.05|Poisson regression||Odds ratio \< 1 means lower odds in terms of days of antibiotics with LAU-7b, odds ratio close to 1 means similar odds in terms of days of antibiotics with LAU-7b or placebo, odds ratio \> 1 means higher odds in terms of days of antibiotics with LAU-7b|Number of days of intravenous antibiotics required for a pulmonary exacerbation, excludes Cycle 1 pulmonary exacerbations, Intent to treat population (ITT), null hypothesis is no treatment effect||2.04|0.60|0.7473
71047005|NCT03265288|141602857|SUPERIORITY||Least Squares Means difference|-2.89||||0.0822|TWO_SIDED|95.0|-6.154|0.374||alpha is set to 0.05|Mixed Model for Repeated Measures||A negative difference favours LAU-7b, a positive difference favours placebo|C-Reactive Protein (CRP), Intent-to-Treat population (ITT), null hypothesis is no treatment effect||0.374|-6.154|0.0822
71047006|NCT03265288|141602857|SUPERIORITY||Least Squares Means difference|-576.0||||0.0603|TWO_SIDED|95.0|-1177.0|25.4||alpha is set to 0.05|Mixed Model for Repeated Measures||A negative difference favours LAU-7b, a positive difference favours placebo|Calprotectin, Intent-to-Treat population (ITT), null hypothesis is no treatment effect||25.4|-1177|0.0603
71047007|NCT03265288|141602857|SUPERIORITY||Least Square Means difference|-3.853||||0.0287|TWO_SIDED|95.0|-7.297|-0.408||alpha is set to 0.05|Mixed Model for Repeated Measures||A negative difference favours LAU-7b, a positive difference favours placebo|C-Reactive Protein (CRP), Per-Protocol population (PP), null hypothesis is no treatment effect||-0.408|-7.297|0.0287
71047008|NCT03265288|141602857|SUPERIORITY||Least Square Means difference|-620.0||||0.0459|TWO_SIDED|95.0|-1228.0|12.0||alpha is set to 0.05|Mixed Model for Repeated Measures||A negative difference favours LAU-7b, a positive difference favours placebo|Calprotectin, Per-Protocol population (PP), null hypothesis is no treatment effect||12|-1228|0.0459
71047009|NCT03265288|141602858|SUPERIORITY||Least Squares Means difference|-0.39||||0.1006|TWO_SIDED|95.0|-0.86|0.08||alpha is set to 0.05|Mixed Model for Repeated Measures|||Body weight, Intent to treat population (ITT), null hypothesis is no treatment effect||0.08|-0.86|0.1006
71047010|NCT03265288|141602859|SUPERIORITY||Least Squares Means difference|-0.137||||0.1246|TWO_SIDED|95.0|-0.312|0.038||alpha is set to 0.05|Mixed Model for Repeated Measures|||Body mass index, intent to treat population (ITT), null hypothesis is no treatment effect||0.038|-0.312|0.1246
71047011|NCT03265288|141602860|SUPERIORITY|||||||0.764||||||alpha is set to 0.05|ANOVA|||Intent to treat population (ITT), null hypothesis is no treatment effect||||0.7640
71047012|NCT03265288|141602861|SUPERIORITY||Least Squares Means difference|-2.758||||0.2996|TWO_SIDED|95.0|-7.998|2.482||alpha is set to 0.05|Mixed Model for Repeated Measures|||CFQ-R Respiratory subscore, intent to treat population (ITT), null hypothesis is no treatment effect||2.482|-7.998|0.2996
70941386|NCT03334747|141383472|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
71047013|NCT03716076|141602875|OTHER|mixed-effects linear regression|||||||||||||||||To compare time values to baseline, post-hoc Tukey's test was applied|||
71047014|NCT03728634|141602931|SUPERIORITY||||||<|0.001|||||||Analysis of Variance(ANOVA)|||Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 45 mg||||<0.001
71047015|NCT03728634|141602931|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 60 mg||||<0.001
71047016|NCT03728634|141602931|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 90 mg||||<0.001
71047017|NCT03728634|141602931|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 45 mg||||<0.001
71047018|NCT03728634|141602931|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 60 mg||||<0.001
71047019|NCT03728634|141602931|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 90 mg||||<0.001
71047020|NCT03728634|141602931|SUPERIORITY|||||||0.036|||||||ANOVA|||Change From Baseline in Plasma TTR Levels Following Single-Dose Administration of ION-TTR-LRx at Day 29: 120 mg||||0.036
71047021|NCT03728634|141602932|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 45 mg||||<0.001
71047022|NCT03728634|141602932|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 60 mg||||<0.001
71047023|NCT03728634|141602932|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 90 mg||||<0.001
71047024|NCT03728634|141602932|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 45 mg||||<0.001
71047025|NCT03728634|141602932|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 60 mg||||<0.001
71047026|NCT03728634|141602932|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 90 mg||||<0.001
70928646|NCT04800211|141353081|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 7. (mITT Population)|Mean Difference (Net)|0.111||||0.4012|TWO_SIDED|95.0|-0.149|0.371|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 7. (mITT Population)||0.371|-0.149|0.4012
70928647|NCT04800211|141353081|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 5. (mITT Population)|Mean Difference (Net)|-0.485||||0.0133|TWO_SIDED|95.0|-0.895|-0.074|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 5. (mITT Population)||-0.074|-0.895|0.0133
70928648|NCT04800211|141353081|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 7. (mITT Population)|Mean Difference (Net)|-0.797||||0.0002|TWO_SIDED|95.0|-1.277|-0.317|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 7. (mITT Population)||-0.317|-1.277|0.0002
70928649|NCT04800211|141353081|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 5. (mITT Population)|Mean Difference (Net)|-0.29||||0.2641|TWO_SIDED|95.0|-0.699|0.119|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 5. (mITT Population)||0.119|-0.699|0.2641
70928650|NCT04800211|141353081|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 7. (mITT Population)|Mean Difference (Net)|-0.453||||0.0639|TWO_SIDED|95.0|-0.924|0.018|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 7. (mITT Population)||0.018|-0.924|0.0639
70928651|NCT04800211|141353081|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to Control on Visit 7. (mITT Population)|Mean Difference (Net)|-0.625||||0.0001|TWO_SIDED|95.0|-0.945|-0.305|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to Control on Visit 7. (mITT Population)||-0.305|-0.945|0.0001
70941387|NCT03334747|141383472|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
71011179|NCT03970330|141529275|SUPERIORITY||Mean Difference (Final Values)|28.9||||0.06|TWO_SIDED|95.0|-1.9|59.6|||Mixed Models Analysis|A single model was run with comparisons between naltrexone and placebo at each visit (not adjusted for multiple comparisons)|Difference calculated as Naltrexone minus Placebo|Comparison of treatment groups at BASELINE||59.6|-1.9|0.06
71011180|NCT03970330|141529275|SUPERIORITY||Mean Difference (Final Values)|10.4||||0.48|TWO_SIDED|95.0|-20.3|41.2|||Mixed Models Analysis|A single model was run with comparisons between naltrexone and placebo at each visit (not adjusted for multiple comparisons)|Difference calculated as Naltrexone minus Placebo|Comparison of treatment groups at WEEK 4||41.2|-20.3|0.48
71047027|NCT03728634|141602932|SUPERIORITY|||||||0.036|||||||Wilcoxon Rank Sum Exact Test (2-sided)|||Change From Baseline in Plasma RBP4 Levels Following Single-Dose Administration of ION-TTR-LRx at Day 29: 120 mg||||0.036
71047028|NCT00076804|141602951|SUPERIORITY_OR_OTHER|||||||0.42||||||Logistic regression analysis \& Cox proportional hazards regression analyses were performed to compare outcomes after adjusting for the relevant covariates,including study arm, age, sex, baseline CD4 cell counts and viral load and pill count adherence|Chi-squared|one degree of freedom||Unadjusted endpoint analyses were conducted on an intention-to-treat basis using all patients enrolled to compare outcomes in the DOT vs. Self-ART arm. For viral load analyses, missing values were considered detectable (missing¼failure analysis). As-treated analyses were also conducted using patients remaining in the study with available data.Crosssectional comparisons between study groups were conducted using two sample t-test,Wilcoxon rank-sum test,chi-squared orFisher's exact and Kaplan-Meier||||0.42
71077851|NCT02913105|141664397|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.88||||0.3086|TWO_SIDED|90.0|0.72|1.08|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 84||1.08|0.72|0.3086
70941388|NCT03334747|141383472|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
71011181|NCT03970330|141529275|SUPERIORITY||Mean Difference (Final Values)|18.9||||0.21|TWO_SIDED|95.0|-11.8|49.6|||Mixed Models Analysis|A single model was run with comparisons between naltrexone and placebo at each visit (not adjusted for multiple comparisons)|Difference calculated as Naltrexone minus Placebo|Comparison of treatment groups at WEEK 8||49.6|-11.8|0.21
71011182|NCT03970330|141529275|SUPERIORITY||Mean Difference (Final Values)|15.5||||0.3|TWO_SIDED|95.0|-15.2|46.2|||Mixed Models Analysis|A single model was run with comparisons between naltrexone and placebo at each visit (not adjusted for multiple comparisons)|Difference calculated as Naltrexone minus Placebo|Comparison of treatment groups at WEEK 12||46.2|-15.2|0.30
71011183|NCT03970330|141529275|SUPERIORITY||Mean Difference (Final Values)|6.8||||0.65|TWO_SIDED|95.0|-24.0|37.5|||Mixed Models Analysis|A single model was run with comparisons between naltrexone and placebo at each visit (not adjusted for multiple comparisons)|Difference calculated as Naltrexone minus Placebo|Comparison of treatment groups at WEEK 16||37.5|-24.0|0.65
71011184|NCT03970330|141529276|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 4||||0.07
71011185|NCT03970330|141529276|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 8||||0.07
71011186|NCT03970330|141529276|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 12||||0.06
71011187|NCT03970330|141529276|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 16||||1.00
71011188|NCT03970330|141529277|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||Comparison of treament groups at WEEK 4||||0.29
71011189|NCT03970330|141529277|SUPERIORITY|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 8||||0.24
71011190|NCT03970330|141529277|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 12||||0.20
71011191|NCT03970330|141529277|SUPERIORITY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 16||||0.53
71011192|NCT03970330|141529278|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 4||||0.37
71011193|NCT03970330|141529278|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 8||||0.39
71103766|NCT00721110|141715020|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.5||||0.76|TWO_SIDED|97.5|-13.0|21.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Lidocaine versus nonlidocaine on postoperative day 1 opioid consumption was assessed using a Wilcoxon rank sum test.||21|-13|0.76
71011194|NCT03970330|141529278|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 12||||0.37
71011195|NCT03970330|141529278|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 16||||0.39
71011196|NCT03970330|141529279|SUPERIORITY||Mean Difference (Final Values)|4.3||||0.08|TWO_SIDED|95.0|-0.6|9.2|||t-test, 2 sided||Difference calculated as Naltrexone minus Placebo|||9.2|-0.6|0.08
71011197|NCT03137173|141529340|NON_INFERIORITY|Non-inferiority was assessed by the two-sided 95% confidence interval (CI) of the between-group difference (ceftobiprole minus vancomycin+aztreonam) using a 10% non-inferiority margin in the ITT population. Difference was computed using the Cochran-Mantel-Haenszel (CMH) weights method, adjusted for geographical region and actual type of ABSSSI.|Risk Difference (RD)|3.3|||||TWO_SIDED|95.0|-1.2|7.8||||||||7.8|-1.2|
71011198|NCT03137173|141529341|NON_INFERIORITY|Non-inferiority was assessed by the two-sided 95% CI of the between-group difference (ceftobiprole minus vancomycin+aztreonam) using a 10% non-inferiority margin in the ITT population. Difference was computed using the CMH weights method, adjusted for geographical region and actual type of ABSSSI.|Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-3.5|5.6||||||||5.6|-3.5|
71011199|NCT03137173|141529342|NON_INFERIORITY|Non-inferiority was assessed by the two-sided 95% CI of the between-group difference (ceftobiprole minus vancomycin plus aztreonam) using a 10% non-inferiority margin in the CE populations. Difference was computed using the CMH weights method, adjusted for geographical region and actual type of ABSSSI.|Risk Difference (RD)|2.7|||||TWO_SIDED|95.0|-0.3|5.6||||||||5.6|-0.3|
71011200|NCT00195702|141529362|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||The 3 primary efficacy variables were considered in a hierarchical order, with the ACR20 response tested first. The ACR20 response rate at Week 24 was initially assessed using Pearson's chi-squared test at a significance level of 0.05. If significant, pairwise comparisons between each adalimumab dose group and the placebo group were performed.||||<0.001
71011201|NCT00195702|141529362|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||The 3 primary efficacy variables were considered in a hierarchical order, with the ACR20 response tested first. The ACR20 response rate at Week 24 was initially assessed using Pearson's chi-squared test at a significance level of 0.05. If significant, pairwise comparisons between each adalimumab dose group and the placebo group were performed.||||<0.001
71011202|NCT00195702|141529363|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||An ANCOVA model with baseline erosion scores as the covariate was performed. An overall significance test at alpha =0.05 was done. Pairwise comparisons, each at alpha =0.05 (2-sided), were performed if the overall test was significant.|ANCOVA|||The 3 primary efficacy variables were considered in a hierarchical order, with the change in modified total Sharp x-ray score at Week 52 tested second. Normality was evaluated by applying the Shapiro-Wilk test procedure to the residuals from the parametric model. The final analysis was performed following a non-parametric approach, ranking the results prior to fitting the model.||||<0.001
71011203|NCT00195702|141529363|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||An ANCOVA model with baseline erosion scores as the covariate was performed. An overall significance test at alpha =0.05 was done. Pairwise comparisons, each at alpha =0.05 (2-sided), were performed if the overall test was significant.|ANCOVA|||The 3 primary efficacy variables were considered in a hierarchical order, with the change in modified total Sharp x-ray score at Week 52 tested second. Normality was evaluated by applying the Shapiro-Wilk test procedure to the residuals from the parametric model. The final analysis was performed following a non-parametric approach, ranking the results prior to fitting the model.||||<0.001
71011204|NCT00195702|141529364|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71011205|NCT00195702|141529364|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71011206|NCT00195702|141529365|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|||||||<0.01
71011207|NCT00195702|141529365|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71011208|NCT00195702|141529366|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71011209|NCT00195702|141529366|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71011210|NCT00195702|141529367|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Normality was evaluated by applying the Shapiro-Wilk test to residuals from the parametric model. The final analysis was performed using a parametric approach.|ANCOVA|||The 3 primary efficacy variables were considered in a hierarchical order, with the change from baseline in the HAQ at Week 52 tested last. The difference among all treatment groups was assessed using ANCOVA with the baseline value as the covariate. If this was significant (p\<=0.05), pairwise comparisons between each adalimumab dose group and placebo were evaluated using the same method.||||<0.001
71011211|NCT00195702|141529367|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Normality was evaluated by applying the Shapiro-Wilk test to residuals from the parametric model. The final analysis was performed using a parametric approach.|ANCOVA|||The 3 primary efficacy variables were considered in a hierarchical order, with the change from baseline in the HAQ at Week 52 tested last. The difference among all treatment groups was assessed using ANCOVA with the baseline value as the covariate. If this was significant (p\<=0.05), pairwise comparisons between each adalimumab dose group and placebo were evaluated using the same method.||||<0.001
71011212|NCT00195702|141529368|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71011213|NCT00195702|141529368|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71011214|NCT00195702|141529370|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71011215|NCT00195702|141529370|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71011216|NCT00195702|141529374|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71011217|NCT00195702|141529374|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71029121|NCT00453362|141565755|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||0.017|TWO_SIDED|95.0|0.11|0.87||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FDG Non-Responders.|The null hypothesis is that there is no difference in PFS between FDG Responders and FDG Non-Responders. The alternative hypothesis is that FDG Responders would have prolonged PFS compared with FDG Non-Responders.||0.87|0.11|0.017
71029122|NCT00453362|141565757|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.076|TWO_SIDED|95.0|0.06|1.42||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FDG Progressive Disease.|The null hypothesis is that there is no difference in PFS between FDG Responders and FDG Progressive Disease. The alternative hypothesis is that FDG Responders would have a prolonged PFS compared to FDG Progressive Disease.||1.42|0.06|0.076
70941389|NCT03334747|141383472|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
71029123|NCT00453362|141565759|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.17||||0.008|TWO_SIDED|95.0|0.04|0.73||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FLT Non-Responders.|The null hypothesis is that there is no difference in PFS between FLT Responders and FLT Non-Responders. The alternative hypothesis is that FLT Responders would have prolonged PFS compared with FLT Non-Responders.||0.73|0.04|0.008
71029124|NCT00453362|141565760|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank|||The null hypothesis is that there is no difference between FLT Responders and FLT Progressive Disease. Alternative hypothesis is that FLT responders would have prolonged PFS compared to FLT Progressive Disease.||||0.049
71029125|NCT00453362|141565761|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36||||0.073|TWO_SIDED|95.0|0.11|1.16||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FDG Non-Responders.|The null hypothesis is that there is no difference in OS between FDG Responders and FDG Non-Responders. The alternative hypothesis is that FDG responders would have prolonged OS compared with FDG Non-Responders.||1.16|0.11|0.073
71029126|NCT00453362|141565764|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.618|TWO_SIDED|95.0|0.14|3.21||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FDG Progressive Disease.|The null hypothesis is that there is no difference in Overall Survival between FDG Responders and FDG Progressive Disease. The alternative hypothesis is that FDG Responders would have prolonged OS compared with FDG Progressive Disease.||3.21|0.14|0.618
71029127|NCT00453362|141565765|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.38||||0.163|TWO_SIDED|95.0|0.09|1.57||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FLT Non-Responders.|The null hypothesis is that there is no difference in OS between FLT Responders and FLT Non-Responders. The alternative hypothesis is that FLT Responders would have prolonged OS compared with FLT Non-Responders.||1.57|0.09|0.163
71103767|NCT00721110|141715020|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.0||||0.66|TWO_SIDED|97.5|-19.0|14.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Ketamine versus nonketamine on postoperative day 1 opioid consumption was assessed using a Wilcoxon rank sum test.||14|-19|0.66
70941390|NCT02567227|141383481|SUPERIORITY||Mean Difference (Net)|-1.03|STANDARD_ERROR_OF_MEAN|1.3|||TWO_SIDED|95.0|-3.6|1.54|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (Mild Cognitive Impairment (MCI) or cognitively normal) were used to compare changes in speed during normal pace walking pre and post intervention.||1.54|-3.60|
71011218|NCT00911508|141529406|SUPERIORITY||Cox Proportional Hazard|0.86|||||TWO_SIDED|95.0|0.65|1.15||||||||1.15|0.65|
71011219|NCT00911508|141529407|SUPERIORITY||Cox Proportional Hazard|0.85|||||TWO_SIDED|95.0|0.6|1.21||||||||1.21|0.60|
71011220|NCT00911508|141529408|SUPERIORITY||Cox Proportional Hazard|0.83|||||TWO_SIDED|95.0|0.74|0.93||||||||0.93|0.74|
71011221|NCT00911508|141529409|SUPERIORITY||Cox Proportional Hazard|0.88|||||TWO_SIDED|95.0|0.72|1.09||||||||1.09|0.72|
71011222|NCT00911508|141529410|SUPERIORITY||Cox Proportional Hazard|0.94|||||TWO_SIDED|95.0|0.53|1.68||||||||1.68|0.53|
71011223|NCT00911508|141529411|SUPERIORITY||Cox Proportional Hazard|0.87|||||TWO_SIDED|95.0|0.51|1.51||||||||1.51|0.51|
71011224|NCT00911508|141529412|SUPERIORITY||Cox Proportional Hazard|0.76|||||TWO_SIDED|95.0|0.33|1.72||||||||1.72|0.33|
71011225|NCT00911508|141529413|SUPERIORITY||Cox Proportional Hazard|1.13|||||TWO_SIDED|95.0|0.41|3.09||||||||3.09|0.41|
71011226|NCT00911508|141529414|SUPERIORITY||Cox Proportional Hazard|0.52|||||TWO_SIDED|95.0|0.45|0.6||||||||0.60|0.45|
71011227|NCT00911508|141529415|SUPERIORITY||Cox Proportional Hazard|0.86|||||TWO_SIDED|95.0|0.77|0.97||||||||0.97|0.77|
71011228|NCT00911508|141529416|SUPERIORITY||Mean Difference (Net)|5.3|||<|0.001|TWO_SIDED|95.0|3.7|6.9|||Mixed Models Analysis|||12 Month||6.9|3.7|<0.001
71011229|NCT00911508|141529416|SUPERIORITY||Mean Difference (Net)|3.4|||<|0.001|TWO_SIDED|95.0|2.1|4.8|||Mixed Models Analysis|||5 Years||4.8|2.1|<0.001
71011230|NCT00911508|141529417|SUPERIORITY||Mean Difference (Net)|-1.7||||0.001|TWO_SIDED|95.0|-2.3|-1.2|||Mixed Models Analysis|||12 Month||-1.2|-2.3|0.001
71011231|NCT00911508|141529417|SUPERIORITY||Mean Difference (Net)|-1.4||||0.001|TWO_SIDED|95.0|-1.9|-0.9|||Mixed Models Analysis|||5 Year||-0.9|-1.9|0.001
71011232|NCT00911508|141529418|SUPERIORITY||Mean Difference (Net)|-1.5|||<|0.001|TWO_SIDED|95.0|-2.0|-1.1|||Mixed Models Analysis|||12 Month||-1.1|-2.0|<0.001
71011233|NCT00911508|141529418|SUPERIORITY||Mean Difference (Net)|-1.0|||<|0.001|TWO_SIDED|95.0|-1.7|-0.4|||Mixed Models Analysis|||5 Year||-0.4|-1.7|<0.001
71011234|NCT01409382|141529422|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.4|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED|95.0|1.5|7.6|||Chi-squared|||Take home babies||7.6|1.5|<0.05
71011235|NCT02058940|141529452|OTHER|||||||0.2|||||||Spearman's Correlation Coefficient|||||||0.2
71011236|NCT01519700|141529457|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limit: -1 day Power: 90% Confidence level: 97.5% Randomization ratio: 1:1 (EP2006:Neupogen)|Mean Difference (Net)|0.04|||||ONE_SIDED|97.5|-0.26||||||The one-sided 97.5% Confidence Interval: \[-0.26, ∞).||||-0.26|
71011237|NCT01789476|141529474|SUPERIORITY_OR_OTHER||||||<|0.05||||||One-sided ANOVA with Treatment Group as a Main Effect|ANOVA|||||||<0.05
71011238|NCT01789476|141529475|SUPERIORITY_OR_OTHER||||||<|0.03||||||One-sided ANOVA with Treatment Group as a Main Effect|ANOVA|||||||<0.03
71011239|NCT01789476|141529476|SUPERIORITY_OR_OTHER||||||<|0.03||||||One-sided ANOVA with Treatment Group as a Main Effect|ANOVA|||||||<0.03
71011240|NCT00965458|141529477|SUPERIORITY_OR_OTHER|||||||0.065|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline ln(AUC+1) as a covariate and change in ln(AUC+1) from baseline as the outcome variable.|ANCOVA|||Primary imputation method used for missing Month 12 AUC. Measuring range for C-peptide is 0.05-30 ng/mL.||||0.065
71011241|NCT00965458|141529478|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome|ANCOVA|||Primary imputation method used for missing Week 52 AUC. Measuring range for C-peptide is 0.05-30 ng/mL||||0.019
71011242|NCT00965458|141529478|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome|ANCOVA|||Primary imputation method used for missing Week 104 AUC. Measuring range for C-peptide is 0.05-30 ng/mL||||0.002
71011243|NCT00965458|141529479|SUPERIORITY_OR_OTHER|||||||0.065|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome|ANCOVA|||Primary imputation method used for missing Week 52 AUC. Measuring range for C-peptide is 0.05-30 ng/mL||||0.065
71011244|NCT00965458|141529479|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome|ANCOVA|||Primary imputation method used for missing Week 104 AUC. Measuring range for C-peptide is 0.05-30 ng/mL||||0.015
71011245|NCT00965458|141529480|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change from baseline as the outcome variable|ANCOVA|||Week 52 mean insulin use comparison||||0.020
71011246|NCT00965458|141529480|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change from baseline as the outcome variable|ANCOVA|||Week 104 mean insulin use comparison||||0.002
71011247|NCT00965458|141529481|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is from a poisson regression comparing the person-year adjusted event rates between the two treatment groups|Regression, Logistic|||Hypoglycemic Events Occurring from Baseline to Week 52||||<0.001
71011248|NCT00965458|141529481|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is from a poisson regression comparing the person-year adjusted event rates between the two treatment groups|Regression, Logistic|||Hypoglycemic Events Occurring from Week 52 to Week 104||||<0.001
71011249|NCT00965458|141529482|SUPERIORITY_OR_OTHER|||||||0.746|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change from baseline as the outcome variable|ANCOVA|||Week 52 mean HbA1C comparison||||0.746
71011250|NCT00965458|141529482|SUPERIORITY_OR_OTHER|||||||0.942|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change from baseline as the outcome variable|ANCOVA|||Week 104 mean HbA1C comparison||||0.942
71011251|NCT00994123|141529486|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35||||0.008|TWO_SIDED|95.0|0.16|0.76|||Log Rank|||||0.76|0.16|0.008
71011252|NCT00994123|141529486|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.15||||0.059|TWO_SIDED|95.0|0.97|4.76|||Log Rank|||||4.76|0.97|0.059
71011253|NCT00692198|141529507|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.52|TWO_SIDED|95.0|0.79|1.12|||Log Rank|||||1.12|0.79|0.52
71011254|NCT00692198|141529508|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.53|TWO_SIDED|95.0|0.64|1.25|||Log Rank||Hazard ratio, LTOT vs No LTOT|||1.25|0.64|0.53
71011255|NCT00692198|141529509|SUPERIORITY_OR_OTHER||Rate ratio|1.01||||0.81|TWO_SIDED|95.0|0.91|1.13|||Fisher Exact||Rate ratio, LTOT vs No LTOT|||1.13|0.91|0.81
71011256|NCT00692198|141529511|SUPERIORITY_OR_OTHER||Rate ratio|1.08||||0.12|TWO_SIDED|95.0|0.98|1.19|||Fisher Exact||Rate ratio, LTOT vs No LTOT|||1.19|0.98|0.12
71011257|NCT00692198|141529512|SUPERIORITY_OR_OTHER|||||||0.73|||||||t-test, 2 sided|||||||0.73
71011258|NCT00692198|141529513|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||||||0.21
71011259|NCT00692198|141529514|SUPERIORITY_OR_OTHER|||||||0.71|||||||t-test, 2 sided|||||||0.71
71011260|NCT00692198|141529515|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.03
71011261|NCT00692198|141529516|SUPERIORITY_OR_OTHER|||||||0.28|||||||t-test, 2 sided|||||||0.28
71011262|NCT00692198|141529517|SUPERIORITY_OR_OTHER|||||||0.41|||||||t-test, 2 sided|||||||0.41
71103768|NCT00721110|141715020|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.5||||0.3|TWO_SIDED|97.5|-5.0|10.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Lidocaine versus nonlidocaine on postoperative day 2 opioid consumption was assessed using a Wilcoxon rank sum test.||10|-5|0.30
71011263|NCT00692198|141529518|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.09|||||TWO_SIDED|95.0|0.54|8.0|||||Relative risk, LTOT vs No LTOT|||8.00|0.54|
71011264|NCT00692198|141529519|SUPERIORITY_OR_OTHER|||||||0.37|||||||t-test, 2 sided|||||||0.37
71011265|NCT00692198|141529520|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||||||0.21
71011266|NCT03039686|141529553|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.87|||TWO_SIDED|95.0|-2.17|1.27|||||Based on the MMRM using an unstructured covariance matrix -change = Baseline + Age Interactive response system (IXRS) Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||1.27|-2.17|
71011267|NCT03039686|141529553|SUPERIORITY||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|95.0|-1.1|2.26|||||Based on the MMRM using an unstructured covariance matrix -change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||2.26|-1.10|
71011268|NCT03039686|141529555|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.21|0.2|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||0.20|-0.21|
71011269|NCT03039686|141529555|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.12|0.27|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||0.27|-0.12|
71011270|NCT03039686|141529557|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.0|0.06|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||0.06|-0.00|
71011271|NCT03039686|141529557|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.0|0.06|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||0.06|-0.00|
71011272|NCT03039686|141529559|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.08|0.27|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||0.27|-0.08|
71011273|NCT03039686|141529559|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.17|0.18|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||0.18|-0.17|
71011274|NCT03039686|141529561|SUPERIORITY||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|2.41|||TWO_SIDED|95.0|-6.76|2.77|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||2.77|-6.76|
71011275|NCT03039686|141529561|SUPERIORITY||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|2.36|||TWO_SIDED|95.0|-3.71|5.63|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||5.63|-3.71|
71011276|NCT03039686|141529564|SUPERIORITY||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|11.5|||TWO_SIDED|95.0|-21.1|24.6|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||24.6|-21.1|
71011277|NCT03039686|141529564|SUPERIORITY||Mean Difference (Final Values)|11.3|STANDARD_ERROR_OF_MEAN|11.3|||TWO_SIDED|95.0|-11.0|33.6|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||33.6|-11.0|
71011278|NCT02322866|141529574|SUPERIORITY||Least Squares Mean Difference|-4.4|||<|0.0001|TWO_SIDED|95.0|-5.8|-2.9||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|||-2.9|-5.8|< 0.0001
70928652|NCT04800211|141353081|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Test 2 on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Test 2 on Visit 7. (mITT Population)|Mean Difference (Net)|-0.344||||0.0776|TWO_SIDED|95.0|-0.725|0.038|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Test 2 on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Test 2 on Visit 7. (mITT Population)||0.038|-0.725|0.0776
71011279|NCT02322866|141529575|SUPERIORITY||Treatment Rate Difference|7.3||||0.0038|TWO_SIDED|95.0|2.53|12.07||P-values were based on the test of general association between the response and treatment group using Cochran-Mantel-Haenszel test with pooled site as stratification factor.|Cochran-Mantel-Haenszel||sarecycline - placebo|||12.07|2.53|0.0038
71011280|NCT02322866|141529576|SUPERIORITY||Least Squares Mean Difference|-14.4|||<|0.0001|TWO_SIDED|95.0|-19.4|-9.5||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 12||-9.5|-19.4|< 0.0001
71011281|NCT02322866|141529577|SUPERIORITY||Least Squares Mean Difference|-12.6|||<|0.0001|TWO_SIDED|95.0|-17.3|-7.9||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 9||-7.9|-17.3|< 0.0001
71011282|NCT02322866|141529578|SUPERIORITY||Least Squares Mean Difference|-11.8|||<|0.0001|TWO_SIDED|95.0|-16.1|-7.5||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 6||-7.5|-16.1|< 0.0001
71011283|NCT02322866|141529579|SUPERIORITY||Least Squares Mean Difference|-9.4|||<|0.0001|TWO_SIDED|95.0|-13.5|-5.3||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 3||-5.3|-13.5|< 0.0001
71011284|NCT02322866|141529580|SUPERIORITY||Least Squares Mean Difference|-3.8|||<|0.0001|TWO_SIDED|95.0|-5.2|-2.5||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 9||-2.5|-5.2|< 0.0001
71047029|NCT00076804|141602952|SUPERIORITY_OR_OTHER|||||||0.89||||||Logistic regression analysis \& Cox proportional hazards regression analyses were performed to compare outcomes after adjusting for the relevant covariates,including study arm, age, sex, baseline CD4 cell counts and viral load and pill count adherence|Chi-squared|one degree of freedom||Unadjusted endpoint analyses were conducted on an intention-to-treat basis using all patients enrolled to compare outcomes in the DOT vs. Self-ART arm. For viral load analyses, missing values were considered detectable (missing¼failure analysis). As-treated analyses were also conducted using patients remaining in the study with available data.Crosssectional comparisons between study groups were conducted using two sample t-test,Wilcoxon rank-sum test,chi-squared orFisher's exact and Kaplan-Meier||||0.89
71047030|NCT00076804|141602953|SUPERIORITY_OR_OTHER|||||||0.14||||||Logistic regression analysis \& Cox proportional hazards regression analyses were performed to compare outcomes after adjusting for the relevant covariates,including study arm, age, sex, baseline CD4 cell counts and viral load and pill count adherence|Wilcoxon (Mann-Whitney)|||Unadjusted endpoint analyses were conducted on an intention-to-treat basis using all patients enrolled to compare outcomes in the DOT vs. Self-ART arm. For viral load analyses, missing values were considered detectable (missing¼failure analysis). As-treated analyses were also conducted using patients remaining in the study with available data.Crosssectional comparisons between study groups were conducted using two sample t-test,Wilcoxon rank-sum test,chi-squared orFisher's exact and Kaplan-Meier||||0.14
71011285|NCT02322866|141529581|SUPERIORITY||Least Squares Mean Difference|-3.7|||<|0.0001|TWO_SIDED|95.0|-5.0|-2.4||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 6||-2.4|-5.0|< 0.0001
71011286|NCT02322866|141529582|SUPERIORITY||Least Squares Mean Difference|-2.9|||<|0.0001|TWO_SIDED|95.0|-4.1|-1.7||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 3||-1.7|-4.1|< 0.0001
71011287|NCT00224952|141529588|OTHER|||||||0.004|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (4-Methylthio-2-hydroxyiminostilbene) as a function of age||||0.004
71011288|NCT00224952|141529588|OTHER|||||||0.032|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (4-Methylthio-2-hydroxyiminostilbene) as a function of age||||0.032
71011289|NCT00224952|141529588|OTHER|||||||0.018|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Fractional Recovery (MTHIS)) as a function of age||||0.018
71011290|NCT00224952|141529588|OTHER|||||||0.033|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (Fractional Recovery MTHIS)) as a function of age||||0.033
71011291|NCT00224952|141529588|OTHER|||||||0.0004|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (5-N-acetylcysteine-3-ene VPA isomers)) as a function of age||||0.0004
71011292|NCT00224952|141529588|OTHER|||||||0.0003|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (5-N-acetylcysteine-2-ene VPA) ) as a function of age||||0.0003
71011293|NCT00224952|141529588|OTHER||||||<|0.0001|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Total N-acetylcysteine conjugates) as a function of age||||<0.0001
71011294|NCT00224952|141529588|OTHER|||||||0.522|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (Fractional Recovery NAC-3-ene VPA isomers)) as a function of age||||0.522
71011295|NCT00224952|141529588|OTHER|||||||0.925|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (Fractional Recovery NAC-2-ene VPA) ) as a function of age||||0.925
71011296|NCT00224952|141529588|OTHER|||||||0.469|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (Fractional Recovery Total NAC conjugates) as a function of age||||0.469
71011297|NCT00656136|141529589|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.077||||0.7428|TWO_SIDED|95.0|0.862|1.346||P-value is one-sided (afatinib vs placebo) log rank test stratified by gender and baseline ECOG score (0,1 vs 2)|Regression, Cox|Model stratified by gender and baseline ECOG score (0,1 vs 2)||Primary analysis was performed after 358 deaths were observed among randomized patients. The data cut-off date for the primary analysis was 08 July 2010.||1.346|0.862|0.7428
71011298|NCT00656136|141529589|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.976||||0.3955|TWO_SIDED|95.0|0.814|1.17||P-value is one-sided (afatinib vs placebo) log rank test stratified by gender and baseline ECOG score (0,1 vs 2)|Regression, Cox|Model stratified by gender and baseline ECOG score (0,1 vs 2)||Final analysis was performed after 526 deaths were observed among randomized patients. The data cut-off date for the final analysis was 04 October 2013.||1.170|0.814|0.3955
71011299|NCT00656136|141529590|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.381|||<|0.0001|TWO_SIDED|95.0|0.306|0.475||P-value is one-sided (afatinib vs placebo) log rank test stratified by gender and baseline ECOG score (0,1 vs 2)|Regression, Cox|Model stratified by gender and baseline ECOG score (0,1 vs 2)||||0.475|0.306|<0.0001
71011300|NCT00656136|141529591|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|15.61||||0.0071|TWO_SIDED|95.0|2.1|115.0||P-value is derived from logistic regression model adjusted for stratification factors, gender and baseline ECOG score (0, 1 vs 2)|Regression, Logistic|Model stratified by gender and baseline ECOG score (0,1 vs 2)||||115|2.1|0.0071
71011301|NCT01101321|141529609|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|100.0|||||TWO_SIDED|90.0|96.14|104.96|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||104.96|96.14|
71011302|NCT01101321|141529610|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|98.5|||||TWO_SIDED|90.0|95.44|101.73|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||101.73|95.44|
71011303|NCT01101321|141529611|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|98.5|||||TWO_SIDED|90.0|95.42|101.7|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||101.70|95.42|
71011304|NCT01270139|141529612|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||Null hypothesis - Nano group is superior to Ferro group and stenting control||||<0.05
71011305|NCT01270139|141529613|OTHER|The Kolmogorov-Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher's exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher's post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was \>0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control.||||<0.05
71047031|NCT00076804|141602954|SUPERIORITY_OR_OTHER|||||||0.61||||||Logistic regression analysis \& Cox proportional hazards regression analyses were performed to compare outcomes after adjusting for the relevant covariates,including study arm, age, sex, baseline CD4 cell counts and viral load and pill count adherence|Wilcoxon (Mann-Whitney)|||Unadjusted endpoint analyses were conducted on an intention-to-treat basis using all patients enrolled to compare outcomes in the DOT vs. Self-ART arm. For viral load analyses, missing values were considered detectable (missing¼failure analysis). As-treated analyses were also conducted using patients remaining in the study with available data.Crosssectional comparisons between study groups were conducted using two sample t-test,Wilcoxon rank-sum test,chi-squared orFisher's exact and Kaplan-Meier||||0.61
71103769|NCT00721110|141715020|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.79|TWO_SIDED|97.5|-5.0|8.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Ketamine versus nonketamine on postoperative day 2 opioid consumption was assessed using a Wilcoxon rank sum test.||8|-5|0.79
71011306|NCT01270139|141529614|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||Null hypothesis - Nano group is superior to Ferro group and stenting control||||<0.05
71011307|NCT01270139|141529615|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED||||||Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control||||<0.05
71011308|NCT01270139|141529616|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|ONE_SIDED||||||Chi-squared|||The null hypothesis is Nano group is superior to Ferro group and Stenting control||||<0.05
71011309|NCT01270139|141529617|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|ONE_SIDED||||||Chi-squared|||The null hypothesis is Nano group is superior to Ferro group and Stenting control||||<0.05
71103770|NCT00721110|141715021|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.06||||0.58|TWO_SIDED|97.5|-0.28|0.41||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared||numerator: lidocaine; denominator: control|Lidocaine versus nonlidocaine on PACU (postoperative care unit) nausea assessed using Pearson chi square test.||0.41|-0.28|0.58
71011310|NCT01270139|141529618|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nano group is superior to Ferro group and stenting control||||<0.05
71011311|NCT01270139|141529619|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nanogroup is superior to Ferro group and stenting control||||<0.05
71011312|NCT01270139|141529620|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED||||||Chi-squared|||The null hypothesis is Nanogroup is superior to Ferro group and stenting control||||<0.05
71011313|NCT01270139|141529621|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nano group is superior to Ferro group and stenting control||||<0.05
71011314|NCT01270139|141529622|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nano groups is superior to Ferro group and Stenting control||||<0.05
71011315|NCT01270139|141529623|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nano group is superior to Ferro group and Stenting control||||<0.05
71011316|NCT01270139|141529624|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nano groups is superior to Ferro group and Stenting control||||<0.05
71011317|NCT01270139|141529625|OTHER|The Kolmogorov-Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher's exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher's post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was \>0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control.||||<0.05
71011318|NCT01270139|141529626|OTHER|The Kolmogorov-Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher's exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher's post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was \>0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control.||||<0.05
71011319|NCT01270139|141529627|OTHER|The Kolmogorov-Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher's exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher's post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was \>0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control.||||<0.05
71103771|NCT00721110|141715021|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.02||||0.87|TWO_SIDED|97.5|-0.32|0.36||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared||Numinator: ketamine; denominator: nonketamine|Ketamine versus nonketamine on PACU (postoperative care unit) nausea assessed using Pearson chi square test.||0.36|-0.32|0.87
71011320|NCT01270139|141529628|OTHER|The Kolmogorov-Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher's exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher's post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was \>0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control.||||<0.05
71011321|NCT01270139|141529629|OTHER|The Kolmogorov-Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher's exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher's post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was \>0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|t-test, 2 sided|||Null hypothesis is ex-vivo arm with exposure of nanoparticles is superior to saline control.||||<0.05
71011322|NCT02452320|141529630|OTHER|||||||0.59|||||||t-test, 2 sided|||||||0.59
71011323|NCT01072175|141529643|NON_INFERIORITY_OR_EQUIVALENCE|Cmax of dabrafenib was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|0.79|1.34|||||Geometric mean ratio (Day 15 Cmax/Day 1 Cmax) and 90% confidence interval for dabrafenib were calculated.|||1.34|0.79|
71011324|NCT01072175|141529643|NON_INFERIORITY_OR_EQUIVALENCE|Cmax of GSK2285403 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.78|1.25|||||Geometric mean ratio (Day 15 Cmax/Day 1 Cmax) and 90% confidence interval for GSK2285403 were calculated.|||1.25|0.78|
71011325|NCT01072175|141529643|NON_INFERIORITY_OR_EQUIVALENCE|Cmax of GSK2298683 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|0.84|1.27|||||Geometric mean ratio (Day 15 Cmax/Day 1 Cmax) and 90% confidence interval for GSK2298683 were calculated.|||1.27|0.84|
71011326|NCT01072175|141529643|NON_INFERIORITY_OR_EQUIVALENCE|Cmax of GSK2167542 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|0.98|||||TWO_SIDED|90.0|0.66|1.45|||||Geometric mean ratio (Day 15 Cmax/Day 1 Cmax) and 90% confidence interval for GSK2167542 were calculated.|||1.45|0.66|
71011327|NCT01072175|141529644|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-t) of dabrafenib was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.01|||||TWO_SIDED|90.0|0.85|1.19|||||Geometric mean ratio (Day 15 AUC(0-inf)/ Day 1 AUC(0-inf)) and 90% confidence interval for dabrafenib were calculated.|||1.19|0.85|
71011328|NCT01072175|141529644|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-inf) of dabrafenib was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.82|1.08|||||Geometric mean ratio (Day 15 AUC(0-inf)/ Day 1 AUC(0-inf)) and 90% confidence interval for dabrafenib were calculated.|||1.08|0.82|
71011329|NCT01072175|141529644|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-t) of GSK2285403 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.84|1.25|||||Geometric mean ratio (Day 15 AUC(0-t)/ Day 1 AUC(0-t)) and 90% confidence interval for GSK2285403 were calculated.|||1.25|0.84|
71047032|NCT04295135|141602956|SUPERIORITY||Mean Difference (Net)|0.002|STANDARD_ERROR_OF_MEAN|0.001|<|0.05|TWO_SIDED|||||A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.|Regression, Linear|Model also included an interaction term for treatment and post-OneSheet access.|The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.|||||<0.05
71047033|NCT04295135|141602957|SUPERIORITY||Median Difference (Net)|0.007|STANDARD_ERROR_OF_MEAN|0.001|<|0.01|TWO_SIDED|||||A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.|Regression, Linear|Model also included an interaction term for treatment and post-OneSheet access.|The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.|||||<0.01
71047034|NCT04295135|141602958|SUPERIORITY||Mean Difference (Net)|0.022|STANDARD_ERROR_OF_MEAN|0.008|<|0.01|TWO_SIDED|||||A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.|Regression, Linear|Model also included an interaction term for treatment and post-OneSheet access.|The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.|||||<0.01
70928653|NCT04800211|141353082|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.621||||0.0055|TWO_SIDED|95.0|-1.055|-0.186|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.186|-1.055|0.0055
70928654|NCT04800211|141353082|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.778||||0.0011|TWO_SIDED|95.0|-1.24|-0.316|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.316|-1.240|0.0011
70928655|NCT04800211|141353082|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.26|-0.54|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.540|-1.260|<.0001
70928656|NCT04800211|141353082|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.52||||0.015|TWO_SIDED|95.0|-0.938|-0.103|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.103|-0.938|0.0150
70928657|NCT04800211|141353082|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.349||||0.1048|TWO_SIDED|95.0|-0.771|0.074|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.074|-0.771|0.1048
70941391|NCT02567227|141383481|SUPERIORITY||Mean Difference (Net)|0.59|STANDARD_ERROR_OF_MEAN|1.61|||TWO_SIDED|95.0|-2.59|3.76||P-values from linear mixed effects models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status|||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in speed during walking while talking pre and post intervention.||3.76|-2.59|
71047035|NCT04295135|141602959|SUPERIORITY||Median Difference (Net)|-0.005|STANDARD_ERROR_OF_MEAN|0.006|>|0.05|TWO_SIDED|||||A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.|Regression, Linear|Model also included an interaction term for treatment and post-OneSheet access.|The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.|||||>0.05
71011330|NCT01072175|141529644|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-inf) of GSK2285403 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|0.92|||||TWO_SIDED|90.0|0.81|1.03|||||Geometric mean ratio (Day 15 AUC(0-inf)/ Day 1 AUC(0-inf)) and 90% confidence interval for GSK2285403 were calculated.|||1.03|0.81|
71011331|NCT01072175|141529644|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-t) of GSK2298683 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.81|1.29|||||Geometric mean ratio (Day 15 AUC(0-t)/ Day 1 AUC(0-t)) and 90% confidence interval for GSK2298683 were calculated.|||1.29|0.81|
71011332|NCT01072175|141529644|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-t) of GSK2167542 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.76|1.37|||||Geometric mean ratio (Day 15 AUC(0-t)/ Day 1 AUC(0-t)) and 90% confidence interval for GSK2167542 were calculated.|||1.37|0.76|
71011333|NCT01072175|141529651|SUPERIORITY_OR_OTHER||Unconditional exact method|-4.0|||||TWO_SIDED|95.0|-23.1|15.9||||||Difference in response rate Arm2 - Arm1||15.9|-23.1|
71011334|NCT01072175|141529651|SUPERIORITY_OR_OTHER||Unconditional exact method|22.0|||||TWO_SIDED|95.0|2.5|40.7||||||Difference in response rate Arm3 - Arm1||40.7|2.5|
71011335|NCT01072175|141529652|SUPERIORITY_OR_OTHER||Unconditional exact method|-6.0|||||TWO_SIDED|95.0|-24.9|14.1||||||Difference in response rate Arm2- Arm1||14.1|-24.9|
71011336|NCT01072175|141529652|SUPERIORITY_OR_OTHER||Unconditional exact method|15.0|||||TWO_SIDED|95.0|-4.9|33.7||||||Difference in response rate Arm3 - Arm1||33.7|-4.9|
71011337|NCT01072175|141529653|SUPERIORITY_OR_OTHER||Response rate|6.0|||||TWO_SIDED|95.0|5.1|26.8||||||||26.8|5.1|
71011338|NCT01072175|141529654|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.0048|TWO_SIDED|95.0|0.38|0.87|||Log Rank||HRs were estimated using the Pike estimator.|||0.87|0.38|0.0048
71011339|NCT01072175|141529654|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.29|0.68|||Log Rank||HRs were estimated using the Pike estimator.|||0.68|0.29|<0.0001
71011340|NCT01072175|141529656|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.1667|TWO_SIDED|95.0|0.45|1.18|||Log Rank||HRs were estimated using the Pike estimator.|||1.18|0.45|0.1667
71011341|NCT01072175|141529656|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.54||||0.0119|TWO_SIDED|95.0|0.32|0.9|||Log Rank||HRs were estimated using the Pike estimator.|||0.90|0.32|0.0119
71011342|NCT01072175|141529664|NON_INFERIORITY_OR_EQUIVALENCE|Following loge tranformation, Cmax of dabrafenib after repeat doses from the pooled data in Part B and D were analyzed by a linear model with the following fixed effects as categorical variables: Capsule type (Gelatin or HPMC), BRAF dose (75 or 150 mg BID), Capsule type by BRAF dose interaction, Day (Day 15 or 21), MEK dose (0, 1, 1.5 or 2 mg QD). Geometric mean ratio (HPMC/Gelatin) and the corresponding 90% CI were provided for BRAF dose level 150 mg BID.|Geometric Mean Ratio|1.51|||||TWO_SIDED|90.0|1.1|2.08|||||Geometric mean ratio (HPMC/Gelatin) and the corresponding 90% CI were provided for BRAF dose level 150 mg BID.|||2.08|1.10|
71011343|NCT01072175|141529666|NON_INFERIORITY_OR_EQUIVALENCE|Following loge transformation, AUC(0-tau) of dabrafenib was analyzed by a linear mixed effect model with dosing chort and day as fixed effects and subject as random effect. Based on the model, geometric mean ratio (Day 21 Dabrafenib 150 mg BID+Trametinib 2 mg QD/Day 21 Dabrafenib 150 mg BID alone) and the corresponding 90% confidence interval were provided.|Geometric Mean Ratio|1.23|||||TWO_SIDED|90.0|0.89|1.69|||||Geometric mean ratio (Day 21 Dabrafenib 150 mg BID+Trametinib 2 mg QD/Day 21 Dabrafenib 150 mg BID alone) and the corresponding 90% confidence interval were provided.|||1.69|0.89|
71011344|NCT01072175|141529666|NON_INFERIORITY_OR_EQUIVALENCE|Following loge tranformation, AUC(0-tau) of dabrafenib after repeat doses from the pooled data in Part B and D were analyzed by a linear model with the following fixed effects as categorical variables: Capsule type (Gelatin or HPMC), BRAF dose (75 or 150 mg BID), Capsule type by BRAF dose interaction, Day (Day 15 or 21), MEK dose (0, 1, 1.5, 2 or 2 mg QD). Geometric mean ratio (HPMC/Gelatin) and the corresponding 90% CI were then provided for BRAF dose level 150 mg BID.|Geometric Mean Ratio|1.1|||||TWO_SIDED|90.0|0.84|1.44|||||Geometric mean ratio (HPMC/Gelatin) and the corresponding 90% CI were provided for BRAF dose level 150 mg BID.|||1.44|0.84|
71011345|NCT00218439|141529700|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
71011346|NCT00218439|141529701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|||||||Mixed Models Analysis|||||||0.006
71011347|NCT00218439|141529702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56|||||||Mixed Models Analysis|||||||0.56
71011348|NCT00218439|141529703|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33|||||||Mixed Models Analysis|||||||0.33
71011349|NCT00218439|141529704|SUPERIORITY_OR_OTHER_LEGACY|||||||0.82|||||||Mixed Models Analysis|||||||0.82
71011350|NCT01474291|141529720|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.023|TWO_SIDED|95.0|1.06|2.3|||Wald Chi-square|Wald Chi-square Test for Type 3 generalized estimating equation (GEE) Analysis.||"Influence of baseline factor Patient's Age (\>=65) upon physician's decision to initiate tocilizumab monotherapy (multivariate analysis)."||2.30|1.06|0.0230
71011351|NCT01474291|141529720|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.74|||<|0.0001|TWO_SIDED|95.0|3.92|8.43|||Wald Chi-square|Wald Chi-square Test for Type 3 GEE Analysis.||"Influence of baseline factor No methotrexate (MTX) sequences within the two last years upon physician's decision to initiate tocilizumab monotherapy (multivariate analysis)."||8.43|3.92|<0.0001
71011352|NCT01474291|141529720|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.03||||0.0212|TWO_SIDED|95.0|1.11|3.7|||Wald Chi-square|Wald Chi-square Test for Type 3 GEE Analysis.||"Influence of baseline factor Past history of severe infectious disease upon physician's decision to initiate tocilizumab monotherapy (multivariate analysis)."||3.70|1.11|0.0212
71047036|NCT04295135|141602960|SUPERIORITY||Median Difference (Net)|-0.005|STANDARD_ERROR_OF_MEAN|0.001|<|0.01|TWO_SIDED|||||A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.|Regression, Linear|Model also included an interaction term for treatment and post-OneSheet access.|The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.|||||<0.01
71103772|NCT00721110|141715021|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.06||||0.61|TWO_SIDED|97.5|-0.31|0.44||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared|||Lidocaine versus nonlidocaine on POD 1 (first postoperative day) nausea assessed using Pearson chi square test.||0.44|-0.31|0.61
71103773|NCT00721110|141715021|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.03||||0.79|TWO_SIDED|97.5|-0.34|0.41||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared|||Ketamine versus nonketamine on POD 1(first postoperative day) nausea assessed using Pearson chi square test.||0.41|-0.34|0.79
71011353|NCT01474291|141529720|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.0076|TWO_SIDED|95.0|1.05|1.41|||Wald Chi-square|Wald Chi-square Test for Type 3 GEE Analysis.||"Influence of baseline factor Higher Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) (unit=1) on physician decision to initiate tocilizumab monotherapy; DAS28-ESR was calculated from the number of swollen joints and tender joints using 28-joint count, ESR (millimeters per hour \[mm/hour\]) and patient's global assessment of disease activity; scores range from 0 to 10; higher scores correspond to greater disease activity (multivariate analysis)."||1.41|1.05|0.0076
71011354|NCT02790476|141529758|SUPERIORITY||Mean Difference (Final Values)|-27.8|||<|0.05|TWO_SIDED|95.0|-38.2|-17.63||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (288.36-347.65 = -59.29) and control (318.60-350.09 = -31.49) arms, resulting in a difference of -27.80.|1-3 months post intervention||-17.63|-38.20|<0.05
71011355|NCT02790476|141529758|SUPERIORITY||Mean Difference (Final Values)|-12.42|||<|0.01|TWO_SIDED|95.0|-18.4|-6.55||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (167.83-347.65 = -179.83) and control (182.67-350.09 = -167.41) arms, resulting in a difference of -12.42.|||-6.55|-18.40|<0.01
71011356|NCT02790476|141529759|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.224|TWO_SIDED|95.0|-0.92|0.22||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (3.45-3.74 = -0.29) and control (3.45-4.59= -0.64) arms, resulting in a difference of -0.35.|Change in mean number of =\> 50 MME prescriptions pre- to 1-3 months post-intervention||0.22|-0.92|0.224
71011357|NCT02790476|141529759|SUPERIORITY||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.08|-0.33||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (3.00-3.74 = -0.74) and control (3.15-4.59= -1.44) arms, resulting in a difference of -0.70.|Change in mean number of =\> 50 MME prescriptions pre- to 4-12 months post-intervention||-0.33|-1.08|<0.001
71011358|NCT02790476|141529759|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.279|TWO_SIDED|95.0|-0.59|0.17||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (2.00-2.14 = -0.14) and control (2.20-2.55= -0.35) arms, resulting in a difference of -0.21.|Change in mean number of \> 90 MME prescriptions pre- to 1-3 months post-intervention||0.17|-0.59|0.279
71011359|NCT02790476|141529759|SUPERIORITY||Mean Difference (Final Values)|-0.38|||<|0.01|TWO_SIDED|95.0|-0.63|-0.12||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (1.71-2.14 = -0.43) and control (1.74-2.55= -0.81) arms, resulting in a difference of -0.38.|Change in mean number of \> 90 MME prescriptions pre- to 4-12 months post-intervention||-0.12|-0.63|<0.01
71011360|NCT02790476|141529760|SUPERIORITY||Mean Difference (Final Values)|-1.6|||<|0.05|TWO_SIDED|95.0|-3.2|-0.1||The threshold for statistical significance was p=0.05.|Mixed Models Analysis|Pre-intervention values were trimmed at 95% with bootstrapped means and confidence intervals.|This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean DME in the letter (72.3-76 = -3.7) and control (82-82.9 = -0.9) arms, resulting in a difference of -1.6.|||-0.1|-3.2|<0.05
71011361|NCT02790476|141529762|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.823|TWO_SIDED|95.0|-0.23|0.29||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (2.44-3.72 = -1.28) and control (2.26-3.51= -1.25) arms, resulting in a difference of 0.03.|Change in mean number of new patients pre- to 1-3 months post-intervention||0.29|-0.23|0.823
71011362|NCT02790476|141529762|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.692|TWO_SIDED|95.0|-0.2|0.14||The threshold for statistical significance is p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (2.08-3.72 = -1.64) and control (1.84-3.51= -1.67) arms, resulting in a difference of -0.03.|Change in mean number of new patients pre- to 4-12 months post-intervention||0.14|-0.20|0.692
71011363|NCT00679354|141529775|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|0.0||||1|TWO_SIDED||||||Spearman's Correlation|||||||1.000
71011364|NCT00679354|141529776|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|0.56||||0.057|TWO_SIDED||||||Spearman's Correlation|||||||0.057
71011365|NCT00679354|141529777|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|-0.22||||0.495|TWO_SIDED||||||Spearman's Correlation|||||||0.495
71011366|NCT00679354|141529778|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|-0.48||||0.114|TWO_SIDED||||||Spearman's Correlation|||||||0.114
71011367|NCT03947333|141529784|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.221|TWO_SIDED||||||t-test, 1 sided|||||||0.221
71011368|NCT03947333|141529784|OTHER||fixed-effects estimate of intervention|0.846||||0.559|TWO_SIDED|95.0|-1.99|3.68|||Mixed Models Analysis|||Mixed effects model||3.68|-1.99|0.559
71011369|NCT03947333|141529785|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.532|TWO_SIDED||||||t-test, 1 sided|||||||0.532
70928658|NCT04800211|141353082|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.846|||<|0.0001|TWO_SIDED|95.0|-1.185|-0.507|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.507|-1.185|<.0001
70928659|NCT04800211|141353082|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.873|||<|0.0001|TWO_SIDED|95.0|-1.127|-0.619|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.619|-1.127|<.0001
70928660|NCT04800211|141353082|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.247||||0.2525|TWO_SIDED|95.0|-0.178|0.671|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.671|-0.178|0.2525
70928661|NCT04800211|141353082|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.098||||0.6503|TWO_SIDED|95.0|-0.33|0.527|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.527|-0.330|0.6503
71011370|NCT03947333|141529786|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.086|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.086
71103774|NCT00721110|141715021|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|-0.13||||0.26|TWO_SIDED|97.5|-0.38|0.12||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared|||Lidocaine versus nonlidocaine on PACU (postoperative care unit) vomiting assessed using Pearson chi square test.||0.12|-0.38|0.26
71011371|NCT03947333|141529786|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.562|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.562
71011372|NCT03947333|141529786|OTHER||fixed-effects estimate of intervention|0.348||||0.451|TWO_SIDED|95.0|-0.557|1.254|||Mixed Models Analysis|||Mixed Effects Model||1.254|-0.557|0.451
71011373|NCT03947333|141529787|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.27|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.270
71011374|NCT03947333|141529787|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.299|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.299
71011375|NCT03947333|141529787|OTHER||fixed-effects estimate of intervention|0.1||||0.917|TWO_SIDED|95.0|-1.786|1.986|||Mixed Models Analysis|||Mixed effects model||1.986|-1.786|0.917
71011376|NCT03947333|141529788|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.093|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.093
71011377|NCT03947333|141529788|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.034|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.034
71011378|NCT03947333|141529788|OTHER||fixed-effects estimate of intervention|0.242||||0.103|TWO_SIDED|95.0|-0.049|0.533|||Mixed Models Analysis|||Mixed Effects Model||0.533|-0.049|0.103
71011379|NCT03947333|141529789|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.116|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.116
71011380|NCT03947333|141529789|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.009|TWO_SIDED||||||t-test, 1 sided|||||||0.009
71011381|NCT03947333|141529789|OTHER||fixed-effects estimate of intervention|0.183||||0.178|TWO_SIDED|95.0|-0.084|0.451|||Mixed Models Analysis|||Mixed Effects Model||0.451|-0.084|0.178
71103775|NCT00721110|141715021|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|-0.06||||0.71|TWO_SIDED|97.5|-0.31|0.19||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared|||Ketamine versus nonketamine on PACU (postoperative care unit) vomiting assessed using a Pearson chi square test.||0.19|-0.31|0.71
70928662|NCT04800211|141353082|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.239||||0.1759|TWO_SIDED|95.0|-0.109|0.588|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.588|-0.109|0.1759
70928663|NCT04800211|141353082|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.867||||0.0293|TWO_SIDED|95.0|-1.674|-0.06|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.060|-1.674|0.0293
70941392|NCT02567227|141383482|SUPERIORITY||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-0.49|0.2|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in SPPB scores pre and post intervention.||0.20|-0.49|
71011382|NCT03947333|141529790|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.188|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.188
71011383|NCT03947333|141529790|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.749|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.749
71011384|NCT03947333|141529790|OTHER||fixed-effects estimate of intervention|0.031||||0.847|TWO_SIDED|95.0|-0.288|0.351|||Mixed Models Analysis|||Mixed Effects Model||0.351|-0.288|0.847
71011385|NCT03947333|141529791|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.182|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.182
71011386|NCT03947333|141529791|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.158|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.158
71011387|NCT03947333|141529791|OTHER||fixed-effects estimate of intervention|0.107||||0.612|TWO_SIDED|95.0|-0.305|0.519|||Mixed Models Analysis|||Mixed Effects Model||0.519|-0.305|0.612
71011388|NCT03947333|141529792|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.97|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.970
71011389|NCT03947333|141529792|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.786|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.786
71011390|NCT03947333|141529792|OTHER||fixed-effects estimate of intervention|-0.088||||0.67|TWO_SIDED|95.0|-0.493|0.317|||Mixed Models Analysis|||Mixed Effects Model||0.317|-0.493|0.670
71011391|NCT03947333|141529793|SUPERIORITY||Median Difference (Final Values)|0.0||||0.478|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.478
71011392|NCT03947333|141529793|SUPERIORITY||Mean Difference (Net)|-0.2||||0.666|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.666
71011393|NCT03947333|141529793|OTHER||fixed-effects estimate of intervention|-0.15||||0.601|TWO_SIDED|95.0|-0.713|0.413|||Mixed Models Analysis|||Mixed Effects Model||0.413|-0.713|0.601
71011394|NCT03947333|141529794|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.654|TWO_SIDED||||||t-test, 1 sided|||||||0.654
71011395|NCT03947333|141529795|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.485|TWO_SIDED||||||t-test, 1 sided|||||||0.485
71011396|NCT03947333|141529796|OTHER|||||||0.48|||||||McNemar|||||||0.480
71011397|NCT03947333|141529796|OTHER|||||||0.023|||||||McNemar|||||||0.023
71011398|NCT03947333|141529797|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.542|TWO_SIDED||||||t-test, 1 sided|||||||0.542
71011399|NCT02735382|141529887|SUPERIORITY||Odds Ratio (OR)|4.663|||<|0.0001|TWO_SIDED|95.0|4.116|5.283|||Chi-squared, Corrected|||||5.283|4.116|<.0001
71011400|NCT02735382|141529888|SUPERIORITY||Odds Ratio (OR)|3.284|||<|0.0001|TWO_SIDED|95.0|2.672|4.035|||Chi-squared, Corrected|||||4.035|2.672|<.0001
71011401|NCT02735382|141529889|SUPERIORITY||Odds Ratio (OR)|0.885||||0.8438|TWO_SIDED|95.0|0.42|1.698|||Chi-squared, Corrected|||||1.698|0.420|.8438
71011402|NCT02735382|141529890|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.161||0.007|TWO_SIDED|95.0|0.123|0.757|||t-test, 2 sided|df=292||A change score from baseline to 6-months was computed and served as the data to be analyzed in the t-test of group differences.||0.757|0.123|.007
71011403|NCT02242305|141529891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.809|TWO_SIDED|90.0|-0.33|0.27|||ANCOVA|Analysis of Covariance (ANCOVA) model including treatment and center as fixed effects and baseline pain intensity as a covariate was used.|Treatment differences were estimated by reference to the Least Squares (LS) mean differences within 3 days and the corresponding 90% CIs. The mean difference calculated as Hyoscine Butylbromide tablets 10 mg - Hyoscine Butylbromide capsules 10 mg.|||0.27|-0.33|0.809
70928664|NCT04800211|141353082|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.876||||0.0362|TWO_SIDED|95.0|-1.714|-0.038|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.038|-1.714|0.0362
70941393|NCT02567227|141383483|SUPERIORITY||Mean Difference (Net)|0.83|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|95.0|-2.13|3.79|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in stride length during walking while talking pre and post intervention.||3.79|-2.13|
71011404|NCT02242305|141529891|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.05||||0.809|TWO_SIDED|95.0|-0.39|0.33|||ANCOVA|Analysis of Covariance (ANCOVA) model including treatment and center as fixed effects and baseline pain intensity as a covariate was used.|Treatment differences were estimated by reference to the Least Squares (LS) mean differences within 1 day and the corresponding 90% CIs. The mean difference calculated as Hyoscine Butylbromide tablets 10 mg - Hyoscine Butylbromide capsules 10 mg.|||0.33|-0.39|0.809
71011405|NCT02242305|141529892|SUPERIORITY_OR_OTHER|||||||0.079|||||||ANCOVA|Analysis of Covariance (ANCOVA) model including treatment and center as fixed effects and baseline pain intensity as a covariate was used.||||||0.079
71047037|NCT04295135|141602961|SUPERIORITY||Median Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.003|>|0.05|TWO_SIDED|||||A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.|Regression, Linear|Model also included an interaction term for treatment and post-OneSheet access.|The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.|||||>0.05
71011406|NCT02242305|141529897|SUPERIORITY_OR_OTHER|||||||0.531|||||||ANCOVA|Analysis of Covariance (ANCOVA) model including treatment and center as fixed effects and baseline score as covariates was used.||||||0.531
71047038|NCT03835325|141602969|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||"The sample size calculation was based on the following hypothesis test:~H0: there is no improvement in memory capacity between the initial (VS) and final (VF) assessments, assessed by the self-efficacy factor of the MIAr questionnaire.~H1: there is an improvement in memory capacity between the initial (VS) and final (VF) assessments, assessed by the self-efficacy factor of the MIAr questionnaire.~or H0: AUTO-EF (VF) - AUTO-EF (VS) ≤ 0 H1: AUTO-EF (VF) - AUTO-EF (VS)\> 0"||||<0.001
71047039|NCT03852459|141602977|SUPERIORITY|||||||0.4272|||||||ANCOVA|||||||0.4272
71047040|NCT01138111|141602994|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||The baseline neocortical SUVR in those subjects who progressed to AD over the 2 year follow-up was compared to the neocortical SUVR of those that did not progress by a Wilcoxon-Mann-Whitney test.||||0.0001
71047041|NCT01138111|141602994|SUPERIORITY_OR_OTHER|||||||0.0011|||||||Wilcoxon (Mann-Whitney)|||The 12 month neocortical SUVR in those subjects who progressed to AD over the 2 year follow-up was compared to the neocortical SUVR of those that did not progress by a Wilcoxon-Mann-Whitney test.||||0.0011
71047042|NCT01138111|141602994|SUPERIORITY_OR_OTHER|||||||0.0008|||||||Wilcoxon (Mann-Whitney)|||The 24 month neocortical SUVR in those subjects who progressed to AD over the 2 year follow-up was compared to the neocortical SUVR of those that did not progress by a Wilcoxon-Mann-Whitney test.||||0.0008
71047043|NCT00560937|141603015|SUPERIORITY_OR_OTHER|||||||0.048|||||||t-test, 2 sided|||T-test of change scores, pregnenolone vs. placebo post-treatment compared to baseline.||||.048
71047044|NCT00560937|141603016|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||t-test, 2 sided|||||||0.79
71047045|NCT00560937|141603017|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||t-test, 2 sided|||||||0.22
71103776|NCT00721110|141715021|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.06||||0.52|TWO_SIDED|97.5|-0.23|0.36||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared|||Lidocaine versus nonlidocaine on postoperative day 1 vomiting assessed using a Pearson chi square test.||0.36|-0.23|0.52
71011407|NCT05489146|141529898|SUPERIORITY|||||||0.046|||||||Mixed Models Analysis|||||||0.046
71011408|NCT05489146|141529899|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|||||||0.003
71047046|NCT00560937|141603018|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||T-test of change scores, pregnenolone compared to placebo post-treatment vs. pre-randomization.||||1.0
71047047|NCT00560937|141603019|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||t-test, 2 sided|||||||0.014
71047048|NCT03629028|141603021|NON_INFERIORITY|Data compared to meta-analysis conducted in Sardo et al., 2017||||||0.05|||||||Chi-squared|Chi-squared or Fisher's test statistic was used to compare the categorical variables.||The sample size was calculated based on the study of Sardo et al. The website http://powerandsamplesize.com/Calculators was used. As a result of the sample size calculation with 90% power and 0.05 alpha error, it was planned to include 141 patients in each group.||||0.05
71047049|NCT01846273|141603042|NON_INFERIORITY|pre-defined non-inferiority margin of 5 letters|Least Squares Mean|3.2|||<|0.001|ONE_SIDED|95.0|0.38||||ANCOVA||||||0.38|<0.001
71047050|NCT01846273|141603043|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71047051|NCT03431974|141603060|SUPERIORITY|||||||0.43|||||||Fisher Exact|||The efficacy of LD-AMT established using a step-down analysis approach with one-sided Fisher's exact tests. First, the analysis for subjects attaining PASI 75 will be performed, then, if that analysis shows a significant treatment effect, analysis for subjects attaining a sPGA success will be performed.||||0.43
71047052|NCT00375492|141603188|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Mixed Model Repeated Measures|||||||0.0030
70850354|NCT00947882|141188491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||0.2342||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 3. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 10 mg and Placebo at Month 3."|Analysis of Covariance (ANCOVA) of the change from baseline in IPSS at Month 3 in the FAS population using the Last Observation Carried Forward (LOCF) method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.2342
70941394|NCT02567227|141383483|SUPERIORITY||Mean Difference (Net)|-1.95|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED||||||||Estimates with standard errors are from linear mixed effect models.|Unadjusted linear mixed effects models were used to compare changes in stride length during normal walking pre and post intervention.||||
71011409|NCT05489146|141529900|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71011410|NCT05489146|141529901|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
71011411|NCT05489146|141529902|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71011412|NCT05489146|141529903|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71011413|NCT05489146|141529904|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
71011414|NCT05489146|141529905|SUPERIORITY|||||||0.035|||||||Mixed Models Analysis|||||||0.035
71011415|NCT00078715|141529932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.004|STANDARD_ERROR_OF_MEAN|1.141||0.527|TWO_SIDED|95.0|-4.26|2.251||The significance level reflects the direct comparison of drugs after factoring out baseline depression levels.|Mixed Models Analysis|A linear mixed model was used with factors for drug, time of evaluation, the drug by time interaction, and a baseline depression covariate.||The hypothesis was that yohimbine would provide lower levels of depression than placebo. Initial estimates of sample size assumed a minimum of 25 patients were required to detect differences in depression.||2.251|-4.260|.527
71011416|NCT00643851|141529936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.86|STANDARD_ERROR_OF_MEAN|0.1243|<|0.0001|TWO_SIDED|95.0|-1.11|-0.62||Primary endpoint was tested at alpha=0.05; significance was claimed only if DAPA 5MG + MET was superior to both controls.|ANCOVA|||||-0.62|-1.11|<0.0001
71011417|NCT00643851|141529936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.1245|<|0.0001|TWO_SIDED|95.0|-0.94|-0.45||Primary endpoint was tested at alpha=0.05; significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-0.45|-0.94|<0.0001
71047053|NCT00375492|141603189|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mixed Model Repeated Measures|||||||<0.0001
71047054|NCT00375492|141603191|SUPERIORITY_OR_OTHER|||||||0.1985||95.0|||||Mixed Model Repeated Measures|||||||0.1985
71011418|NCT00643851|141529937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.1|STANDARD_ERROR_OF_MEAN|3.883|<|0.0001|TWO_SIDED|95.0|-26.7|-11.4||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-11.4|-26.7|<0.0001
71011419|NCT00643851|141529937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-27.5|STANDARD_ERROR_OF_MEAN|3.897|<|0.0001|TWO_SIDED|95.0|-35.1|-19.8||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-19.8|-35.1|<0.0001
71011420|NCT00643851|141529938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29.9|STANDARD_ERROR_OF_MEAN|4.633|<|0.0001|TWO_SIDED|95.0|20.8|39.0||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|modified logistic regression|||||39.0|20.8|<0.0001
71047055|NCT00375492|141603192|SUPERIORITY_OR_OTHER|||||||0.1827||95.0|||||ANCOVA|||||||0.1827
71047056|NCT00375492|141603193|SUPERIORITY_OR_OTHER|||||||0.1584||95.0|||||ANCOVA|||||||0.1584
71011421|NCT00643851|141529938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|17.8|STANDARD_ERROR_OF_MEAN|4.947||0.0003|TWO_SIDED|95.0|8.1|27.4||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||27.4|8.1|0.0003
71011422|NCT00643851|141529939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.34|STANDARD_ERROR_OF_MEAN|0.1938|<|0.0001|TWO_SIDED|95.0|-1.72|-0.96||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-0.96|-1.72|<0.0001
71011423|NCT00643851|141529939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.19|STANDARD_ERROR_OF_MEAN|0.1912|<|0.0001|TWO_SIDED|95.0|-1.57|-0.82||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-0.82|-1.57|<0.0001
71011424|NCT00643851|141529940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.3388||0.8769|TWO_SIDED|95.0|-0.72|0.61||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||0.61|-0.72|0.8769
71047057|NCT00375492|141603194|SUPERIORITY_OR_OTHER|||||||0.8279||95.0|||||ANCOVA|||||||0.8279
71047058|NCT00375492|141603195|SUPERIORITY_OR_OTHER|||||||0.8334||95.0|||||ANCOVA|||||||0.8334
71047059|NCT00375492|141603196|SUPERIORITY_OR_OTHER|||||||0.2881||95.0|||||ANCOVA|||||||0.2881
71047060|NCT00375492|141603197|SUPERIORITY_OR_OTHER|||||||0.0654||95.0|||||ANCOVA|||||||0.0654
71047061|NCT00375492|141603198|SUPERIORITY_OR_OTHER|||||||0.728||95.0|||||Cochran-Mantel-Haenszel|||||||0.728
71047062|NCT00375492|141603199|SUPERIORITY_OR_OTHER|||||||0.127||95.0|||||ANOVA|||||||0.127
71047063|NCT01232491|141603200|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.49||||0.132||95.0|-0.15|1.13||If the p-value for the two-sided test was less than 5%, and D (the estimated treatment difference \[dietary intervention versus no dietary intervention\]) was less than 0 then superiority for dietary intervention was considered confirmed.|Regression, Linear|||Normal linear regression model with treatment, strata, use of insulin secretagogue at screening, sex and region as factors and age and weight at baseline as covariates. Superiority was considered confirmed if the upper bound of the two-sided 95% CI for the estimated treatment difference (dietary intervention versus no dietary intervention), which was calculated using the FAS, was below 0 kg.||1.13|-0.15|0.132
71011425|NCT00643851|141529940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|0.3399|<|0.0001|TWO_SIDED|95.0|-2.04|-0.71||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-0.71|-2.04|<0.0001
71011426|NCT00643851|141529941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.4191|||TWO_SIDED|95.0|-0.98|0.66||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||0.66|-0.98|
71011427|NCT00643851|141529941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.57|STANDARD_ERROR_OF_MEAN|0.4201|||TWO_SIDED|95.0|-2.4|-0.74||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-0.74|-2.40|
71011428|NCT04557189|141529945|SUPERIORITY||Adjusted Treatment Difference|0.241|||||TWO_SIDED|95.0|0.031|0.452|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||0.452|0.031|
71011429|NCT04557189|141529946|SUPERIORITY||Adjusted Treatment Difference|0.175|||||TWO_SIDED|95.0|-0.044|0.394|||||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on Cochran-Mantel-Haenszel (CMH) method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|0.394|-0.044|
71011430|NCT04557189|141529947|SUPERIORITY||Adjusted Treatment Difference|-0.094|||||TWO_SIDED|95.0|-0.253|0.059|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||0.059|-0.253|
71011431|NCT04557189|141529948|SUPERIORITY||Adjusted Treatment Difference|-0.141|||||TWO_SIDED|95.0|-0.316|0.033|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||0.033|-0.316|
71011432|NCT04557189|141529949|SUPERIORITY||Adjusted Treatment Difference|0.191|||||TWO_SIDED|95.0|-0.029|0.41|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||0.410|-0.029|
71011433|NCT04557189|141529950|SUPERIORITY||Adjusted Treatment Difference|0.146|||||TWO_SIDED|95.0|-0.073|0.365|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||0.365|-0.073|
71011434|NCT04557189|141529951|SUPERIORITY||Adjusted Treatment Difference|-0.234|||||TWO_SIDED|95.0|-0.448|-0.019|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||-0.019|-0.448|
71011435|NCT04557189|141529952|SUPERIORITY||Hazard Ratio (HR)|0.393|||||TWO_SIDED|95.0|0.122|1.259|||||The hazard ratio is derived from a Cox proportional hazard model with treatment group and the number of Apfel risk factors (3 or 4) as independent variables.|||1.259|0.122|
71047064|NCT01232491|141603201|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.17||||0.137||95.0|-0.05|0.39|||Regression, Linear|||Normal linear regression model with treatment, use of insulin secretagogue at screening, sex and region as factors, and age and BMI at baseline as covariates.||0.39|-0.05|0.137
71047065|NCT01232491|141603202|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.13||||0.053||95.0|0.0|0.26|||Regression, Linear|||Normal linear regression model with treatment, strata, use of insulin secretagogue at screening and region as factors and HbA1c at baseline as covariate.||0.26|-0.00|0.053
71047066|NCT01232491|141603203|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.07||||0.674||95.0|-0.25|0.39|||Regression, Linear|||Normal linear regression model with treatment, strata, use of insulin secretagogue at screening and region as factors and FPG at baseline as covariate.||0.39|-0.25|0.674
71047067|NCT00856973|141603236|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|7.33|STANDARD_ERROR_OF_MEAN|3.91|>|0.05|TWO_SIDED|97.5|-5.17|19.83|||ANCOVA|Bonferroni adjustment was use for multiple comparisons|Difference calculated as Eszopiclone minus placebo|This endpoint was analyzed using ANCOVA with treatment group (pooled low dose eszopiclone, pooled high dose eszopiclone, and placebo) as a fixed effect and the baseline value as a covariate. Contrast statements were used to perform pairwise comparisons of the eszopiclone treatment groups to placebo. A Bonferroni adjustment was used for the 2 pairwise comparisons. Least squares means and the standard errors were presented for each treatment grou||19.83|-5.17|>0.05
71011436|NCT04557189|141529953|SUPERIORITY||Difference in LSM Estimates|0.188|||||TWO_SIDED|95.0|-0.402|0.777||||||30 Minutes Post Surgery|From MMRM analysis over all post-randomization timepoints, with the Peak VRS score as the outcome, treatment group, timepoint, number of Apfel risk factors and treatment-by-timepoint interaction as fixed effects and participant as random effect with unstructured covariance structure for observed data up to 24 hours post surgery.|0.777|-0.402|
71011437|NCT04557189|141529953|SUPERIORITY||Difference in LSM Estimates|0.401|||||TWO_SIDED|95.0|-0.258|1.059||||||1 Hour Post Surgery|From MMRM analysis over all post-randomization timepoints, with the Peak VRS score as the outcome, treatment group, timepoint, number of Apfel risk factors and treatment-by-timepoint interaction as fixed effects and participant as random effect with unstructured covariance structure for observed data up to 24 hours post surgery.|1.059|-0.258|
71011438|NCT04557189|141529953|SUPERIORITY||Difference in LSM Estimates|0.265|||||TWO_SIDED|95.0|0.0|0.786||||||2 Hours Post Surgery|From MMRM analysis over all post-randomization timepoints, with the Peak VRS score as the outcome, treatment group, timepoint, number of Apfel risk factors and treatment-by-timepoint interaction as fixed effects and participant as random effect with unstructured covariance structure for observed data up to 24 hours post surgery.|0.786|0|
71011439|NCT04557189|141529953|SUPERIORITY||Difference in LSM Estimates|0.097|||||TWO_SIDED|95.0|-0.093|0.286||||||6 Hours Post Surgery|From MMRM analysis over all post-randomization timepoints, with the Peak VRS score as the outcome, treatment group, timepoint, number of Apfel risk factors and treatment-by-timepoint interaction as fixed effects and participant as random effect with unstructured covariance structure for observed data up to 24 hours post surgery.|0.286|-0.093|
71011440|NCT04557189|141529953|SUPERIORITY||Difference in LSM Estimates|-0.203|||||TWO_SIDED|95.0|-0.575|0.17||||||24 Hours Post Surgery|From MMRM analysis over all post-randomization timepoints, with the Peak VRS score as the outcome, treatment group, timepoint, number of Apfel risk factors and treatment-by-timepoint interaction as fixed effects and participant as random effect with unstructured covariance structure for observed data up to 24 hours post surgery.|0.170|-0.575|
71011441|NCT04557189|141529954|SUPERIORITY||Adjusted Treatment Difference|0.146|||||TWO_SIDED|95.0|-0.073|0.365|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||0.365|-0.073|
71011442|NCT01728454|141529961|SUPERIORITY|||||||0.036|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1||||0.0360
71011443|NCT01728454|141529961|SUPERIORITY|||||||0.1087|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1||||0.1087
71011444|NCT01728454|141529961|SUPERIORITY|||||||0.2263|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1||||0.2263
71011445|NCT01728454|141529961|SUPERIORITY|||||||0.5375|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1||||0.5375
71047068|NCT00856973|141603236|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|2.21|STANDARD_ERROR_OF_MEAN|3.91|>|0.05|TWO_SIDED|97.5|-10.23|14.65|||ANCOVA|||This endpoint was analyzed using ANCOVA with treatment group (pooled low dose eszopiclone, pooled high dose eszopiclone, and placebo) as a fixed effect and the baseline value as a covariate. Contrast statements were used to perform pairwise comparisons of the eszopiclone treatment groups to placebo. A Bonferroni adjustment was used for the 2 pairwise comparisons. Least squares means and the standard errors were presented for each treatment group.||14.65|-10.23|>0.05
71047069|NCT03439852|141603258|SUPERIORITY||Mean Difference (Net)|0.83|||<|0.05|TWO_SIDED|95.0|0.26|1.39|||Mixed Models Analysis|||Multilevel modeling for repeated measures was conducted to compare 2 conditions over time. The model included group, time, and the interaction between group and time, adjusting for within-subject correlation. The response was transformed using squared root to satisfy the model assumption.||1.39|0.26|<0.05
71047070|NCT03439852|141603259|SUPERIORITY||Median Difference (Net)|1.14||||0.05|TWO_SIDED|95.0|-0.37|2.64||Calculated|Mixed Models Analysis|||Multilevel modeling conducted for repeated measures comparing minutes per week of light-to-moderate physical activity for participants in two conditions over time. In the multilevel models, participants were nested within Catholic Clubs, adjusting for within-club and within-subject correlations. The model includes group, time, and the interaction between group and time, adjusting for within-subject correlation. The response was transformed using squared root to satisfy the model assumption.||2.64|-0.37|0.05
71011446|NCT01728454|141529962|SUPERIORITY|||||||0.1017|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1||||0.1017
71011447|NCT01728454|141529962|SUPERIORITY|||||||0.1927|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1||||0.1927
71011448|NCT01728454|141529962|SUPERIORITY|||||||0.1017|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1||||0.1017
71011449|NCT01728454|141529962|SUPERIORITY|||||||0.1927|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1||||0.1927
71011450|NCT01728454|141529963|SUPERIORITY|||||||0.7508|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1||||0.7508
71011451|NCT01728454|141529963|SUPERIORITY|||||||0.5507|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1||||0.5507
71011452|NCT01728454|141529963|SUPERIORITY|||||||0.3993|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1||||0.3993
71011453|NCT01728454|141529963|SUPERIORITY|||||||0.5821|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1||||0.5821
71011454|NCT01728454|141529964|SUPERIORITY|||||||0.7507|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.7507
71011455|NCT01728454|141529964|SUPERIORITY|||||||0.8919|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.8919
71011456|NCT01728454|141529965|SUPERIORITY|||||||0.478|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.4780
71011457|NCT01728454|141529965|SUPERIORITY|||||||0.2354|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.2354
71011458|NCT01728454|141529966|SUPERIORITY|||||||0.114|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.1140
71011459|NCT01728454|141529966|SUPERIORITY|||||||0.1636|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.1636
71011460|NCT01728454|141529967|SUPERIORITY|||||||0.114|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.1140
71011461|NCT01728454|141529967|SUPERIORITY|||||||0.0733|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.0733
71011462|NCT01728454|141529968|SUPERIORITY|||||||0.1253|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.1253
71011463|NCT01728454|141529968|SUPERIORITY|||||||0.3442|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.3442
71011464|NCT01728454|141529969|SUPERIORITY|||||||0.0303|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.0303
71011465|NCT01728454|141529969|SUPERIORITY|||||||0.2864|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.2864
71011466|NCT01728454|141529970|SUPERIORITY|||||||0.4365|||||||Wilcoxon Rank- Sum Test|||PTS: LOCF Cycle 1||||0.4365
71011467|NCT01728454|141529970|SUPERIORITY|||||||0.1302|||||||Wilcoxon Rank- Sum Test|||PTS: LOCF Cycle 1||||0.1302
71011468|NCT01728454|141529970|SUPERIORITY|||||||0.3591|||||||Wilcoxon Rank- Sum Test|||PTS: ODI Cycle 1||||0.3591
71011469|NCT01728454|141529970|SUPERIORITY|||||||0.0872|||||||Wilcoxon Rank- Sum Test|||PTS: ODI Cycle 1||||0.0872
71011470|NCT01728454|141529970|SUPERIORITY|||||||0.4814|||||||Wilcoxon Rank- Sum Test|||IS: LOCF Cycle 1||||0.4814
71011471|NCT01728454|141529970|SUPERIORITY|||||||0.9162|||||||Wilcoxon Rank- Sum Test|||IS: LOCF Cycle 1||||0.9162
71011472|NCT01728454|141529970|SUPERIORITY|||||||0.6607|||||||Wilcoxon Rank- Sum Test|||IS: ODI Cycle 1||||0.6607
71011473|NCT01728454|141529970|SUPERIORITY|||||||0.9527|||||||Wilcoxon Rank- Sum Test|||IS: ODI Cycle 1||||0.9527
71011474|NCT01728454|141529971|SUPERIORITY|||||||0.2812|||||||Wilcoxon Rank- Sum Test|||LOCF Cycle 1||||0.2812
71011475|NCT01728454|141529971|SUPERIORITY|||||||0.5858|||||||Wilcoxon Rank- Sum Test|||LOCF Cycle 1||||0.5858
71011476|NCT01728454|141529971|SUPERIORITY|||||||0.4116|||||||Wilcoxon Rank- Sum Test|||ODI Cycle 1||||0.4116
71011477|NCT01728454|141529971|SUPERIORITY|||||||0.4252|||||||Wilcoxon Rank- Sum Test|||ODI Cycle 1||||0.4252
71011478|NCT01728454|141529972|SUPERIORITY|||||||0.6131|||||||Wilcoxon Rank- Sum Test|||SAP: On-Drug Cycle 1||||0.6131
71011479|NCT01728454|141529972|SUPERIORITY|||||||0.7881|||||||Wilcoxon Rank- Sum Test|||SAP: On-Drug Cycle 1||||0.7881
71011480|NCT01728454|141529972|SUPERIORITY|||||||0.9376|||||||Wilcoxon Rank- Sum Test|||SAP: Off-Drug Cycle 1||||0.9376
71011481|NCT01728454|141529972|SUPERIORITY|||||||0.6552|||||||Wilcoxon Rank- Sum Test|||SAP: Off-Drug Cycle 1||||0.6552
71047071|NCT03439852|141603260|SUPERIORITY||Mean Difference (Net)|-0.72||||0.05|TWO_SIDED|95.0|-2.31|0.88|||Mixed Models Analysis|||Multilevel modeling for the repeated measures was conducted comparing the two conditions over time. In the multilevel models, participants were nested within Catholic Clubs, adjusting for within-club and within-subject correlations. The model includes group, time, and the interaction between group and time, adjusting for within-subject correlation. The response was transformed using squared root to satisfy the model assumption.||0.88|-2.31|0.05
71047072|NCT03439852|141603261|SUPERIORITY||Mean Difference (Net)|0.96|||<|0.05|TWO_SIDED|95.0|-2.67|4.6|||Mixed Models Analysis|||Multilevel modeling for the repeated measures was conducted comparing the two conditions over time. In the multilevel models, participants were nested within Catholic Clubs, adjusting for within-club and within-subject correlations. The model includes group, time, and the interaction between group and time, adjusting for within-subject correlation.||4.60|-2.67|<0.05
71047073|NCT03439852|141603262|SUPERIORITY||Mean Difference (Net)|-0.76|||<|0.05|TWO_SIDED|95.0|-1.11|-0.4|||Mixed Models Analysis|||||-0.40|-1.11|<0.05
71047074|NCT03439852|141603263|SUPERIORITY||Mean Difference (Net)|-0.62|||<|0.05|TWO_SIDED|95.0|-1.15|0.1|||Mixed Models Analysis|||||0.10|-1.15|<0.05
71047075|NCT03439852|141603264|SUPERIORITY||Median Difference (Net)|-0.49|||<|0.05|TWO_SIDED|95.0|-2.1|1.11|||Mixed Models Analysis|Repeated measures generalized linear model test effects of time/group, \& interaction rate met MVPA, adjusting for within subject correlation.||||1.11|-2.10|<0.05
71047076|NCT02040779|141603364|SUPERIORITY||LSM difference|0.116||||0.001|TWO_SIDED|95.0|0.048|0.185||ANCOVA model with effects due to baseline trough morning FEV1, sex, age, current protocol-allowed asthma therapy (ICS or non-corticosteroid therapy) at the time of screening visit and during the run-in period and treatment.|ANCOVA||BDP 160 mcg BAI - Placebo BAI|A fixed-sequence multiple testing procedure was used while controlling the family-wise error rate at 5%. If the 2-sided p-value resulting from the ANCOVA model for comparing beclomethasone dipropionate BAI 160 mcg/day versus placebo was less than 0.05, then the comparison of the 80 mcg/day versus placebo was to be interpreted inferentially.||0.185|0.048|0.0010
71047077|NCT02040779|141603364|SUPERIORITY||LSM difference|0.124||||0.0005|TWO_SIDED|95.0|0.054|0.193||ANCOVA model with effects due to baseline trough morning FEV1, sex, age, current protocol-allowed asthma therapy (ICS or non-corticosteroid therapy) at the time of screening visit and during the run-in period and treatment.|ANCOVA||BDP 80 mcg BAI - Placebo BAI|||0.193|0.054|0.0005
71103777|NCT00721110|141715021|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.07||||0.44|TWO_SIDED|97.5|-0.22|0.38|||Chi-squared|||Ketamine versus nonketamine on postoperative day 1 vomiting assessed using Pearson chi square test.||0.38|-0.22|0.44
71103778|NCT00721110|141715022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.96|TWO_SIDED|97.5|-2.14|2.2||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Lidocaine was compared to nonlidocaine on mean VRS fatigue score using a t test.||2.2|-2.14|0.96
71103779|NCT00721110|141715022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.59|TWO_SIDED|97.5|-1.8|2.57||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Ketamine was compared to nonketamine on mean VRS fatigue score using a t test.||2.57|-1.80|0.59
71103780|NCT01554904|141715023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|162.24|STANDARD_ERROR_OF_MEAN|62.4||0.02|TWO_SIDED|95.0|27.32|297.16|||paired t test|||The null hypothesis is that the snore index would not be different after 6 weeks of treatment compared to baseline. The comparison group is the subjects completing the 6 weeks of training and the second sleep study.||297.16|27.32|0.02
71047078|NCT02040779|141603365|SUPERIORITY||LSM difference|7.911||||0.0443|TWO_SIDED|95.0|0.202|15.621||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||15.621|0.202|0.0443
71047079|NCT02040779|141603365|SUPERIORITY||LSM difference|13.645||||0.0007|TWO_SIDED|95.0|5.843|21.446||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||21.446|5.843|0.0007
71047080|NCT02040779|141603366|SUPERIORITY||LSM difference|5.405||||0.2014|TWO_SIDED|95.0|-2.905|13.715||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||13.715|-2.905|0.2014
71103781|NCT01554904|141715024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.66||0.22|TWO_SIDED|95.0|-2.28|0.584||paired t test|t-test, 2 sided|||Participants completing 6 weeks of training and the second sleep study. The null hypothesis was that the AHI would not be different after 6 weeks of training compared to baseline.||0.584|-2.28|0.22
71103782|NCT02038647|141715028|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.113|TWO_SIDED|95.0|0.557|1.067||P-value tests the hypothesis of equal event times in both treatment arms obtained using the Log-rank test stratified by disease subtype as sensitive versus resistant/refractory and the presence of brain metastases.|Log Rank||The stratification factors were: disease subtype as sensitive versus resistant/refractory and the presence of brain metastases (yes or no) with treatment (Alisertib + Paclitaxel vs Placebo + Paclitaxel) as a factor in the model.|||1.067|0.557|0.113
71011482|NCT01728454|141529972|SUPERIORITY|||||||0.7143|||||||Wilcoxon Rank- Sum Test|||EP: On-Drug Cycle 1||||0.7143
71011483|NCT01728454|141529972|SUPERIORITY|||||||0.2985|||||||Wilcoxon Rank- Sum Test|||EP: On-Drug Cycle 1||||0.2985
71047081|NCT02040779|141603366|SUPERIORITY||LSM difference|10.902||||0.0112|TWO_SIDED|95.0|2.5|19.303||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||19.303|2.500|0.0112
71047082|NCT02040779|141603367|SUPERIORITY||LSM difference|-0.388||||0.0175|TWO_SIDED|95.0|-0.708|-0.068||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||-0.068|-0.708|0.0175
71047083|NCT02040779|141603367|SUPERIORITY||LSM difference|-0.358||||0.0285|TWO_SIDED|95.0|-0.678|-0.038||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 80 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||-0.038|-0.678|0.0285
71077852|NCT02913105|141664397|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.86||||0.288|TWO_SIDED|90.0|0.69|1.08|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 42||1.08|0.69|0.2880
71077853|NCT02913105|141664397|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.91||||0.4446|TWO_SIDED|90.0|0.73|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 84||1.12|0.73|0.4446
71011484|NCT01728454|141529972|SUPERIORITY|||||||0.3162|||||||Wilcoxon Rank- Sum Test|||EP: Off-Drug Cycle 1||||0.3162
71011485|NCT01728454|141529972|SUPERIORITY|||||||0.7503|||||||Wilcoxon Rank- Sum Test|||EP: Off-Drug Cycle 1||||0.7503
71011486|NCT01190839|141529973|SUPERIORITY_OR_OTHER|||||||0.097||||||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by the number of risk factors for recurrence of active CD and baseline use of an immunomodulator.|Cochran-Mantel-Haenszel chi-square test|||||||0.097
71011487|NCT01190839|141529974|SUPERIORITY_OR_OTHER||||||<|0.001||||||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by the number of risk factors for recurrence of active CD and baseline use of an immunomodulator.|Cochran-Mantel-Haenszel chi-square test|||||||<0.001
71011488|NCT01190839|141529975|SUPERIORITY_OR_OTHER|||||||0.098||||||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by the number of risk factors for recurrence of active CD and baseline use of an immunomodulator.|Cochran-Mantel-Haenszel chi-square test|||||||0.098
71077854|NCT02913105|141664397|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.9||||0.4127|TWO_SIDED|90.0|0.73|1.11|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 42||1.11|0.73|0.4127
71077855|NCT02913105|141664397|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.8074|TWO_SIDED|90.0|0.85|1.25|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 84||1.25|0.85|0.8074
71077856|NCT02913105|141664397|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.98||||0.6935|TWO_SIDED|90.0|0.88|1.08|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 42||1.08|0.88|0.6935
71077857|NCT02913105|141664397|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.99||||0.9145|TWO_SIDED|90.0|0.9|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 84||1.09|0.90|0.9145
71079469|NCT00482170|141666447|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.203|TWO_SIDED|95.0|0.51|1.15||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.15|0.51|0.203
71011489|NCT02545504|141529986|SUPERIORITY||Cox Proportional Hazard|0.93||||0.5625|TWO_SIDED|95.0|0.74|1.18||The significance level at final analysis is 0.046 (two-sided). Stratum with \< 6 participants or no informative event by combined treatment arms was pooled with the smallest adjacent stratum for stratified analyses.|Log Rank|p-value was stratified by Eastern Cooperative Oncology Group (ECOG) status, geographic region and primary tumor site.|Hazard ratio (HR) was stratified by ECOG status, geographic region and primary tumor site with treatment arm as the only covariate.|The primary and secondary endpoints were tested sequentially in the following gate-keeping order: the primary OS endpoint, then the secondary PFS endpoint, and finally the secondary ORR endpoint.||1.18|0.74|0.5625
71011490|NCT02545504|141529987|SUPERIORITY||Cox Proportional Hazard|0.84||||0.1031|TWO_SIDED|95.0|0.67|1.04||The significance level at final analysis was 0.032 (two-sided). Stratum with \< 6 participants or no informative event by combined treatment arms was pooled with the smallest adjacent stratum for stratified analyses.|Log Rank|p-value was stratified by ECOG status,geographic region and primary tumor site.|HR was stratified by ECOG status,geographic region;primary tumor site with treatment arm as a covariate.Stratum with \<6 participants or no informative event by combined treatment arms was pooled with smallest adjacent stratum for stratified analyses.|The primary and secondary endpoints were tested sequentially in the following gate-keeping order: the primary OS endpoint, then the secondary PFS endpoint, and finally the secondary ORR endpoint. PFS was tested only if OS was significant. The P-value is for display only.||1.04|0.67|0.1031
71079470|NCT00482170|141666447|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.222|TWO_SIDED|95.0|0.51|1.17||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.17|0.51|0.222
71011491|NCT02545504|141529988|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0493|TWO_SIDED|95.0|1.0|2.15||The significance level at final analysis was 0.032 (two-sided). Stratum with \< 6 participants or no informative event by combined treatment arms was pooled with the smallest adjacent stratum for stratified analyses.|Cochran-Mantel-Haenszel|p-value was stratified by ECOG status, geographic region and primary tumor site.|OR was stratified by ECOG status, geographic region and primary tumor site. Stratum with \< 6 participants or no informative event by combined treatment arms was pooled with the smallest adjacent stratum for stratified analyses.|The primary and secondary endpoints were tested sequentially in the following gate-keeping order: the primary OS endpoint, then the secondary PFS endpoint, and finally the secondary ORR endpoint. ORR was tested only if OS and PFS were significant.The P-value is for display only.||2.15|1.00|0.0493
71011492|NCT02545504|141529988|SUPERIORITY||ORR Difference|9.4|||||TWO_SIDED|95.0|0.1|18.8|||||The 2-sided 95% confidence interval (CI) of difference for ORR between the treatment and placebo is calculated based on stratum-adjusted Cochran-Mantel-Haenszel proportion.|The primary and secondary endpoints were tested sequentially in the following gate-keeping order: the primary OS endpoint, then the secondary PFS endpoint, and finally the secondary ORR endpoint. ORR was tested only if OS and PFS were significant.||18.8|0.1|
71079471|NCT00482170|141666447|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.263|TWO_SIDED|95.0|0.53|1.19||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.19|0.53|0.263
71079472|NCT00482170|141666448|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.914|TWO_SIDED|95.0|0.7|1.5||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.50|0.70|0.914
71079473|NCT00482170|141666448|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.827|TWO_SIDED|95.0|0.7|1.57||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.57|0.70|0.827
71011493|NCT01336647|141530001|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The primary efficacy endpoint was responder rate calculated based on the percentage of subjects who were lice free at all follow-up visits (Days 1, 7 and 14). Because the number of responders and non-responders in the family size\>= 5 household members was less than five in at least one of the treatment arms, (Table 14.2.1.5), Fisher's Exact test was used to compare treatment arms, instead of the CMH test.|||||<|0.001|TWO_SIDED|95.0|||||Fisher Exact|The assessment of statistical significance will be done using Hochberg's modified Bonferroni test.||Null hypothesis; 80% power and 0.025 two-sided level of significance for each pairwise active vs. vehicle comparison||||<0.001
71011494|NCT05056311|141530007|SUPERIORITY|||||||0.001||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||||||0.001
71011495|NCT05056311|141530008|SUPERIORITY|||||||0.001||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||||||0.001
71011496|NCT05056311|141530009|SUPERIORITY|||||||0.001||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||||||0.001
71011497|NCT05056311|141530011|SUPERIORITY|||||||0.0001||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||||||0.0001
71011498|NCT05056311|141530012|SUPERIORITY|||||||0.6374||||||The a priori threshold for statistical significance was \<0.05.|McNemar|||||||0.6374
71011499|NCT05111548|141530017|SUPERIORITY|||||||0.923|||||||ANOVA|||Mixed ANOVA (within-subjects factor=time; between-subjects factor=group)||||0.923
71011500|NCT05111548|141530018|SUPERIORITY|||||||0.11|||||||ANOVA|||Mixed ANOVA (within-subjects factor=time; between-subjects factor=group)||||0.110
71011501|NCT05111548|141530019|SUPERIORITY|||||||0.818|||||||ANOVA|||Mixed ANOVA (within-subjects factor=time; between-subjects factor=group)||||0.818
71011502|NCT05111548|141530020|SUPERIORITY|||||||0.13|||||||ANOVA|||Mixed ANOVA (within-subjects factor=time; between-subjects factor=group)||||0.130
71047084|NCT02040779|141603368|SUPERIORITY||LSM difference|-0.137||||0.0335|TWO_SIDED|95.0|-0.263|-0.011||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||-0.011|-0.263|0.0335
71047085|NCT02040779|141603368|SUPERIORITY||LSM difference|-0.127||||0.0509|TWO_SIDED|95.0|-0.255|0.001||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 80 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||0.001|-0.255|0.0509
71047086|NCT02040779|141603370|SUPERIORITY|||||||0.2384|||||||Log Rank|||||||0.2384
71047087|NCT02040779|141603370|SUPERIORITY|||||||0.0208|||||||Log Rank|||||||0.0208
71047088|NCT01936519|141603386|EQUIVALENCE|Mann Whitney U Test was performed|Mean Difference (Net)|27.32|STANDARD_ERROR_OF_MEAN|20.61||0.283|TWO_SIDED|95.0|-16.17|70.8||Cockcroft-Gault Clearance|Wilcoxon (Mann-Whitney)|||Statistical analysis was performed on the Cockcroft Gault Creatinine clearance 2 year data.||70.80|-16.17|0.283
71047089|NCT01936519|141603387|EQUIVALENCE|Wilcoxon Test|Median Difference (Final Values)|34.08|STANDARD_ERROR_OF_MEAN|11.44||0.013|TWO_SIDED|95.0|9.95|58.21|||Wilcoxon (Mann-Whitney)|||Statistical analysis was performed on the MDRD Clearance 2 year data row data.||58.21|9.95|0.013
71047090|NCT01936519|141603388|EQUIVALENCE|Wilcoxon Test|Mean Difference (Final Values)|22.22|STANDARD_ERROR_OF_MEAN|12.09||0.099|TWO_SIDED|95.0|-3.28|47.72|||Wilcoxon (Mann-Whitney)|||Statistical analysis was performed on the Iothalamate Clearance 2 year data.||47.72|-3.28|0.099
71047091|NCT01936519|141603388|EQUIVALENCE|Non-parametric statistical tests were used for all analyses, including the Mann-Whitney U test for continuous outcomes and Pearson's chi-square test for binary outcomes. Univariate statistical tests were used for all comparisons. Cohen's d was utilized for all comparisons to provide information about effect size.|Mean Difference (Final Values)|29.08|STANDARD_ERROR_OF_MEAN|13.29||0.032|TWO_SIDED|95.0|1.04|57.1|||Wilcoxon (Mann-Whitney)|||"Power and sample size. The assumption was made that eGFR would improve from 34 mL/min/1.73 m2 to 43 mL/min/1.73 m2. It was determined that a sample size of 12 in each group would have 80% power to detect a difference in means of -9.0 (the difference between a group 1 mean of 34.0 and a group 2 mean of 43.0) assuming that the common standard deviation was 7.5 using a two group t-test with a 0.05 two-sided significance level.~Data from the 2 year time point was used for analysis."||57.1|1.04|.032
71011503|NCT03330275|141530021|NON_INFERIORITY|A non-inferiority margin of -0.25 was used. Non-inferioirty was concluded if the lower limit of the 95% CI was above 0.25.|Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.0574|||TWO_SIDED|95.0|-0.045|0.183|||Linear Mixed Model|Kenward and Roger Method was used for denominator degrees of freedom|Mean difference was calculated as Test - Control 1|It was calculated that a total of 24 participants was required to show that the Test lens is non-inferior to the control 1 lens with 80% power. Sample size for this study was based on night driving only.||0.183|-0.045|
71011504|NCT03330275|141530022|NON_INFERIORITY|A non-inferiority margin of 0.1 logMAR was used. Non-inferiority was concluded if the upper limit was below 0.1.|Mean Difference (Final Values)|-0.028|STANDARD_ERROR_OF_MEAN|0.0076|||TWO_SIDED|95.0|-0.043|-0.012|||Linear Mixed Model|Kenward and Roger Method was used for the degrees of freedom.|Mean difference was calculated as Test - Control 1|||-0.012|-0.043|
71011505|NCT03330275|141530023|EQUIVALENCE|Equivalence was concluded if 0 was contained in the 95% confidence interval.|Odds Ratio (OR)|3.162|||||TWO_SIDED|95.0|0.442|22.604|||Generalized Estimating Equation||Odds ratio was calculated as Test over Control 1|||22.604|0.442|
71047092|NCT01936519|141603388|EQUIVALENCE|Difference of zero hypothesized.|Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.263||0.015|TWO_SIDED|95.0|-1.11|-0.003|||Wilcoxon (Mann-Whitney)|||Statistical analysis was performed on 2 year data time point.||-0.003|-1.11|0.015
71047093|NCT03687658|141603391|OTHER|Generalized linear mixed model (GLMM) with a binomial distribution using a logit link function||||||0.066|||||||Generalized linear mixed model|||||||0.066
71011506|NCT03330275|141530024|EQUIVALENCE|Equivalence was concluded if 0 was contained in the 95% confidence interval.|Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.82|1.16|||Generalized Linear Mixed Model||Odds ratio was calculated as Test over Control1|||1.16|0.82|
71011507|NCT03330275|141530025|EQUIVALENCE|Equivalence was concluded if 0 was contained in the 95% confidence interval.|Mean Difference (Final Values)|17.8|STANDARD_ERROR_OF_MEAN|5.29|||TWO_SIDED|95.0|7.1|28.5|||Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Test - Control 1|||28.5|7.1|
71011508|NCT03330275|141530026|EQUIVALENCE|Equivalence was concluded if 0 was contained in the 95% confidence interval.|Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.33|1.74|||Generalized Linear Mixed Model||Odds Ratio was calculated as Test over Control 1|||1.74|0.33|
71011509|NCT03330275|141530027|EQUIVALENCE|Equivalence was concluded if 0 was contained in the 95% confidence interval.|Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|7.93|||TWO_SIDED|95.0|-11.4|20.7|||Linear Mixed Model|Kenward and Roger Method was used for denominator Degrees of Freedom.|Mean difference was calculated as Test - Control 1|||20.7|-11.4|
71011510|NCT00151775|141530028|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||Regression, Linear|||Non-weight adjusted dosage||||0.0008
71011511|NCT00151775|141530028|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Linear|||Weight adjusted dosage||||<0.0001
71011512|NCT00151775|141530028|SUPERIORITY_OR_OTHER|||||||0.0032||95.0|||||Regression, Linear|||Non-weight adjusted dosage||||0.0032
71011513|NCT00151775|141530028|SUPERIORITY_OR_OTHER|||||||0.0265||95.0|||||Regression, Linear|||Weight adjusted dosage||||0.0265
71011514|NCT00151775|141530028|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Linear|||Non-weight adjusted dosage||||<0.0001
71047094|NCT03687658|141603392|OTHER|Generalized linear mixed model (GLMM) with a binomial distribution using a logit link function||||||0.273|||||||Generalized linear mixed model|||||||0.273
71047095|NCT03687658|141603393|OTHER|Generalized linear mixed model (GLMM) with a Poisson distribution using a log link function||||||0.403|||||||Generalized linear mixed model|||||||0.403
71011515|NCT00151775|141530028|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Linear|||Weight adjusted dosage||||<0.0001
71011516|NCT00151775|141530029|SUPERIORITY_OR_OTHER||Slope|0.69||||0.0008||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||0.0008
71011517|NCT00151775|141530029|SUPERIORITY_OR_OTHER||Slope|-0.057||||0.0026||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||0.0026
71011518|NCT00151775|141530029|SUPERIORITY_OR_OTHER||Slope|-0.85||||0.0032||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||0.0032
71011519|NCT00151775|141530029|SUPERIORITY_OR_OTHER||Slope|-0.58||||0.0125||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||0.0125
71047096|NCT02701413|141603419|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
71047097|NCT02701413|141603423|OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
71047098|NCT00472797|141603433|SUPERIORITY_OR_OTHER||mean|2.73|||<|0.001||97.5|2.73|2.73||P-Value denotes percent change from baseline to week 12 for all combined subjects.|t-test, 1 sided|||A one-sided paired t-test across all subjects by combining the titrated and non-titrated new formulation groups was performed.||2.73|2.73|<0.001
71103783|NCT02038647|141715030|SUPERIORITY||Cox Proportional Hazard|0.93||||0.714|TWO_SIDED|95.0|0.652|1.341||P-value tests the hypothesis of equal event times in both treatment arms obtained using the Log-rank test stratified by disease subtype as sensitive versus resistant/refractory and the presence of brain metastases.|Log Rank||The stratification factors were: disease subtype as sensitive versus resistant/refractory and the presence of brain metastases (yes or no) with treatment (Alisertib + Paclitaxel vs Placebo + Paclitaxel) as a factor in the model.|||1.341|0.652|0.714
71011520|NCT00151775|141530029|SUPERIORITY_OR_OTHER||Slope|-0.75|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||<0.0001
71011521|NCT00151775|141530029|SUPERIORITY_OR_OTHER||Slope|-0.57|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||<0.0001
71011522|NCT00151775|141530029|SUPERIORITY_OR_OTHER||Slope|-8.97|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||<0.0001
71011523|NCT00151775|141530029|SUPERIORITY_OR_OTHER||Slope|-8.15|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||<0.0001
71011524|NCT00151775|141530029|SUPERIORITY_OR_OTHER||Slope|-7.17||||0.0265||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||0.0265
71011525|NCT00151775|141530029|SUPERIORITY_OR_OTHER||Slope|-6.85||||0.0084||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||0.0084
71011526|NCT00151775|141530029|SUPERIORITY_OR_OTHER||Slope|-8.36|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||<0.0001
71011527|NCT00151775|141530029|SUPERIORITY_OR_OTHER||Slope|-7.71|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||<0.0001
71011528|NCT00151775|141530030|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.58||||0.0093|TWO_SIDED|95.0|-6.27|-0.89|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||Analysis of systolic blood pressure. Null hypothesis of no treatment difference was tested.||-0.89|-6.27|0.0093
71011529|NCT00151775|141530030|SUPERIORITY_OR_OTHER||LS Mean difference|-3.49||||0.0052|TWO_SIDED|95.0|-5.92|-1.05|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||Analysis for diastolic blood pressure. The null hypothesis of no treatment difference was tested.||-1.05|-5.92|0.0052
71011530|NCT00151775|141530030|SUPERIORITY_OR_OTHER||LS Mean difference|-2.57||||0.133|TWO_SIDED|95.0|-5.93|0.79|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||Analysis of systolic blood pressure. Null hypothesis of no treatment difference was tested.||0.79|-5.93|0.1330
71011531|NCT00151775|141530030|SUPERIORITY_OR_OTHER||LS Mean difference|-1.38||||0.3442|TWO_SIDED|95.0|-4.27|1.5|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||Analysis for diastolic blood pressure. The null hypothesis of no treatment difference was tested.||1.50|-4.27|0.3442
71011532|NCT00151775|141530030|SUPERIORITY_OR_OTHER||LS Mean difference|-3.16||||0.0029|TWO_SIDED|95.0|-5.24|-1.09|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||For seated systolic blood pressure the null hypothesis of no treatment difference was tested||-1.09|-5.24|0.0029
71047099|NCT00472797|141603434|SUPERIORITY_OR_OTHER|||||||0.466||||||P-value denotes difference between treatment groups|ANOVA|||||||0.466
71047100|NCT00472797|141603434|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value denotes the mean percent change from baseline to week 12.|t-test, 1 sided|||||||<0.001
71047101|NCT00472797|141603434|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value denotes the mean percent change from baseline to week 12.|t-test, 1 sided|||||||0.003
71011533|NCT00151775|141530030|SUPERIORITY_OR_OTHER||LS Mean difference|-2.8||||0.0032|TWO_SIDED|95.0|-4.65|-0.95|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||For seated diastolic blood pressure the null hypothesis of no treatment difference was tested.||-0.95|-4.65|0.0032
71047102|NCT00472797|141603435|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value refers to change in total score from baseline to week 12 for all domains, except global side effect score, in the MSTCQ for all subjects combined.|t-test, 1 sided|Paired t-test for change from baseline to week 12||Change in total score from baseline to week 12 for all subjects combined. Lower scores indicate a more favorable response||||<0.001
71047103|NCT00472797|141603435|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||P-value refers to differences between treatment groups in change in total score from baseline to week 12 for all domains, except global side effect score, in the MSTCQ.|ANOVA|||Analysis evaluated differences between treatment groups in change in total score from baseline to week 12 for all domains, except global side effect score, in the MSTCQ. Lower scores indicate a more favorable response.||||0.110
71047104|NCT00472797|141603436|SUPERIORITY_OR_OTHER|||||||0.302||95.0||||P-value refers to differneces in total score from baseline to week 12 between treatment groups.|ANOVA|||Analysis evaluates total score from baseline to week 12 for differences between each treatment group.||||0.302
71047105|NCT00472797|141603438|SUPERIORITY_OR_OTHER|||||||0.899||95.0||||P-value denotes differences between treatment groups in change in diameter of injection site redness from baseline to week 12.|ANOVA|||Analysis evaluates differences between treatment groups in change in diameter of injection site redness from baseline to week 12.||||0.899
71047106|NCT00472797|141603439|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|Paired||Physical Component - Change from Baseline to Week 12||||<0.001
71047107|NCT00472797|141603439|SUPERIORITY_OR_OTHER|||||||0.234||95.0|||||t-test, 2 sided|Paired||Physical Component - Change from Baseline to Week 36||||0.234
71047108|NCT00472797|141603439|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|Paired||Physical Component - Change from Baseline to Extension Visit 1||||0.001
71047109|NCT00472797|141603439|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|Paired||Physical Component - Change from Baseline to Extension Visit 3||||0.004
71047110|NCT00472797|141603439|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||t-test, 2 sided|Paired||Physical Component - Change from Baseline to Exisit Visit LOCF||||0.036
71047111|NCT00472797|141603439|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|Paired||Mental Component - Baseline to Week 12||||0.002
71047112|NCT00472797|141603439|SUPERIORITY_OR_OTHER|||||||0.468||95.0|||||t-test, 2 sided|Paired||Mental Component - Baseline to Week 36||||0.468
71047113|NCT00472797|141603439|SUPERIORITY_OR_OTHER|||||||0.602||95.0|||||t-test, 2 sided|Paired||Mental Component - Change from Baseline to Extension Visit 1||||0.602
71047114|NCT00472797|141603439|SUPERIORITY_OR_OTHER|||||||0.414||95.0|||||t-test, 2 sided|Paired||Change from Baseline to Extension Visit 3||||0.414
71047115|NCT00472797|141603439|SUPERIORITY_OR_OTHER|||||||0.991||95.0|||||t-test, 2 sided|Paired||Change from Baseline to Exit Visit LOCF||||0.991
71047116|NCT03399318|141603471|SUPERIORITY||||||<|0.0001||||||treatment group as the factor of interest, country and disease severity 207 (CM=yes, no) as stratification factors, and admission temperature as a covariate. A t-test for significance of the treatment effect, were derived from this model.|t-test, 2 sided|||The analysis of the primary outcome variable, Tmax, involved fitting an analysis of 206 covariance model with treatment group as the factor of interest, country and disease severity 207 (CM=yes, no) as stratification factors, and admission temperature as a covariate. The estimated 208 treatment effect and associated 95% confidence interval, as well as a t-test for significance of the treatment effect, were derived from this model.||||<0.0001
71011534|NCT00151775|141530031|SUPERIORITY_OR_OTHER||LS Mean difference|-2.82||||0.2113|TWO_SIDED|95.0|-7.29|1.65|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||For seated systolic blood pressure the null hypothesis of no treatment difference was tested.||1.65|-7.29|0.2113
71011535|NCT00151775|141530031|SUPERIORITY_OR_OTHER||LS Mean difference|-2.92||||0.1496|TWO_SIDED|95.0|-6.92|1.09|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||For seated diastolic blood pressure the null hypothesis of no treatment difference was tested.||1.09|-6.92|0.1496
71011536|NCT01008059|141530034|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
71047117|NCT03399318|141603472|SUPERIORITY||Odds Ratio (OR)|0.09|||<|0.05|TWO_SIDED|95.0|0.03|0.27|||Regression, Logistic|||Seizure occurrence defined as a three-level ordinal variable was analyzed using a 223 multinomial logistic regression model because there was evidence that the proportional odds 224 assumption did not hold. This model included treatment group as the factor of interest and 225 country and disease severity as stratification factors. The adjusted treatment group odds ratio, 226 and its associated 95% confidence interval were derived from this model.||.27|.03|<0.05
71047118|NCT03399318|141603473|SUPERIORITY||Odds Ratio, log|6.3|||<|0.05|TWO_SIDED|95.0|-5.1|17.7||The covariance matrix for the within-participant observations was 232 modeled using an unstructured pattern.|ANCOVA|Time to parasite clearance was 235 evaluated using a discrete-time proportional hazards model with a complementary log-log link.|The adjusted treatment group difference in mean area 233 under the log10(HRP2 level) × time curve was estimated using appropriate contrasts among the 234 treatment group means over time that quantify this comparison.|Parasite clearance measured by log10 (HRP2 level) was analyzed with a repeated 228 measures analysis of covariance model (mixed model repeated measures)35 with terms for 229 treatment group, country, disease severity, log10(HRP2 level) at admission, time (treated as a 230 categorical variable), and interaction terms for admission log10(HRP2 level) and time, and for 231 treatment group and time.|The model included terms for treatment group, country, and disease severity.|17.7|-5.1|<0.05
71047119|NCT03399318|141603474|SUPERIORITY||Odds Ratio (OR)|0.32|||<|0.05|TWO_SIDED|95.0|0.2|0.52||An ordinal logistic regression model assuming 216 proportional odds with terms for treatment group, country, and disease severity as covariates was used to derive the estimated adjusted treatment group odds ratio and 95%CI|Regression, Logistic|Sensitivity analyses with best-case and worst-case imputation were 219 performed to accommodate missing data||A secondary efficacy measure included fever exposure as measured by the area under 214 the temperature × time curve for T≥38.5°C during the 72-hour follow-up period, categorized as 215 0, \> 0 and \< 2, and ≥ 2 degree-hours.||.52|.20|<0.05
71011537|NCT04516291|141530036|OTHER||Least Square (LS) Mean difference|-22.4|STANDARD_ERROR_OF_MEAN|4.93|<|0.001|TWO_SIDED|95.0|-32.1|-12.7|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-12.7|-32.1|<0.001
71011538|NCT04516291|141530036|OTHER||LS Mean difference|-22.0|STANDARD_ERROR_OF_MEAN|4.88|<|0.001|TWO_SIDED|95.0|-31.7|-12.4|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-12.4|-31.7|<0.001
71011539|NCT04516291|141530036|OTHER||LS Mean difference|-24.1|STANDARD_ERROR_OF_MEAN|5.05|<|0.001|TWO_SIDED|95.0|-34.1|-14.2|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-14.2|-34.1|<0.001
71047120|NCT02749292|141603475|EQUIVALENCE|Using a two-sided log-rank test with an alpha level of 0.05, a projected relapse risk of 15% in the superior group and 30% in the inferior group, and an estimated enrollment time of 36 months, it was determined that 200 patients were required to detect a significant difference with a power of 0.80. Due to the coronavirus disease 2019 (COVID-19) pandemic and the deleterious impact of rituximab on vaccination efficacy, the trial was concluded before reaching the target enrollment of 200.|Hazard Ratio (HR)|0.37||||0.045|TWO_SIDED|95.0|0.15|0.9|||Log Rank|||"The difference between the two treatment strategies was assessed using the log-rank test. P values of 0.05 were considered significant. Both rows were included and combined in the statistical analysis (ANCA-PR3 and ANCA-MPO) to assess the difference in treatment strategies.~Null hypothesis: No difference in the ANCA and B-cell arm in the probability of relapses."||0.90|0.15|0.045
71047121|NCT02749292|141603476|OTHER|chi square test||||||0.87|||||||Chi-squared|||"Null hypothesis: No difference in the proportion of patients with SAEs in each arm"||||0.87
71047122|NCT02749292|141603481|OTHER||||||<|1|TWO_SIDED|95.0|||||t-test, 2 sided|||Null hypothesis: no difference in the mean number of infusions per patient in each arm.||||<0001
71047123|NCT02749292|141603482|OTHER||Mean Difference (Final Values)|-0.14||||0.17|TWO_SIDED|95.0|-0.34|-0.06|||t-test, 2 sided|||Null hypothesis: there is no difference in the mean change from baseline Vasculitis Damage Index between each arm. A t-test was used.||-0.06|-0.34|0.17
71047124|NCT02749292|141603483|OTHER|Using a two-sided log-rank test with an alpha level of 0.05, a projected relapse risk of 15% in the superior group and 30% in the inferior group, and an estimated enrollment time of 36 months, it was determined that 200 patients were required to detect a significant difference with a power of 0.80. Due to the coronavirus disease 2019 (COVID-19) pandemic and the deleterious impact of rituximab on vaccination efficacy, the trial was concluded before reaching the target enrollment of 200.|Hazard Ratio (HR)|1.64||||0.42|TWO_SIDED|95.0|0.5|5.36|||Log Rank|||"The difference between the two treatment strategies was assessed using the log-rank test. P values of 0.05 were considered significant.~Null hypothesis: No difference in the ANCA and B-cell arm in the probability of relapses"||5.36|0.50|0.42
71047125|NCT00251641|141603491|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|Pearson's chi-square test||The treatment comparison for this endpoint was carried at the 4.9% level of significance.||||<0.001
71047126|NCT00251641|141603492|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Multiplicity adjustment was provided using Hochberg test.|Chi-squared|Pearson's chi-square test||||||<0.001
71047127|NCT00251641|141603493|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Multiplicity adjustment was provided using the Hochberg test.|Chi-squared|Pearson's chi-square test||||||<0.001
71047128|NCT00251641|141603494|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Multiplicity adjustment was provided using the Hochberg test.|Chi-squared|Pearson's chi-square test||||||<0.001
71047129|NCT04017754|141603502|EQUIVALENCE|A p-value \<0.05 was considered significant for at difference in frequency of low p-MBL level(\<500 ug/l) between groups.|Prevalence proportion ratio|1.79|||<|0.001|TWO_SIDED|95.0|1.34|2.38|||Chi-squared||The numerator is the risk of low p-MBL in the study sample with RPL patients and the denominator is the risk of low p-MBL in control group 1 of female blood donors.|Comparing the risk of low p-MBL level between RPL patients and MBL reference group. We hypothesized that more RPL patients had a low p-MBL level; thus, the null hypothesis was that no difference existed.||2.38|1.34|<0.001
71011540|NCT04516291|141530036|OTHER||LS Mean difference|-27.7|STANDARD_ERROR_OF_MEAN|4.09|<|0.001|TWO_SIDED|95.0|-35.7|-19.6|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-19.6|-35.7|<0.001
71011541|NCT04516291|141530036|OTHER||LS Mean difference|-26.6|STANDARD_ERROR_OF_MEAN|3.98|<|0.001|TWO_SIDED|95.0|-34.5|-18.8|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-18.8|-34.5|<0.001
71011542|NCT04516291|141530036|OTHER||LS Mean difference|-24.7|STANDARD_ERROR_OF_MEAN|3.96|<|0.001|TWO_SIDED|95.0|-32.5|-16.9|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-16.9|-32.5|<0.001
71011543|NCT04516291|141530036|OTHER||LS Mean difference|-26.5|STANDARD_ERROR_OF_MEAN|4.51|<|0.001|TWO_SIDED|95.0|-35.4|-17.6|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-17.6|-35.4|<0.001
71011544|NCT04516291|141530038|OTHER||LS Mean difference|-44.0|STANDARD_ERROR_OF_MEAN|6.66|<|0.001|TWO_SIDED|95.0|-57.1|-30.8|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-30.8|-57.1|<0.001
71011545|NCT04516291|141530038|OTHER||LS Mean difference|-43.8|STANDARD_ERROR_OF_MEAN|6.64|<|0.001|TWO_SIDED|95.0|-56.9|-30.7|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-30.7|-56.9|<0.001
71011546|NCT04516291|141530038|OTHER||LS Mean difference|-41.3|STANDARD_ERROR_OF_MEAN|6.85|<|0.001|TWO_SIDED|95.0|-54.8|-27.8|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-27.8|-54.8|<0.001
70928665|NCT04800211|141353082|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-1.139|||<|0.0001|TWO_SIDED|95.0|-1.809|-0.469|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.469|-1.809|<.0001
70928666|NCT04800211|141353082|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.767||||0.0621|TWO_SIDED|95.0|-1.559|0.025|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.025|-1.559|0.0621
70928667|NCT04800211|141353082|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.447||||0.5259|TWO_SIDED|95.0|-1.246|0.352|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.352|-1.246|0.5259
71011547|NCT04516291|141530038|OTHER||LS Mean difference|-50.5|STANDARD_ERROR_OF_MEAN|5.54|<|0.001|TWO_SIDED|95.0|-61.4|-39.6|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-39.6|-61.4|<0.001
71011548|NCT04516291|141530038|OTHER||LS Mean difference|-45.9|STANDARD_ERROR_OF_MEAN|5.38|<|0.001|TWO_SIDED|95.0|-56.5|-35.2|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-35.2|-56.5|<0.001
71011549|NCT04516291|141530038|OTHER||LS Mean difference|-50.7|STANDARD_ERROR_OF_MEAN|5.35|<|0.001|TWO_SIDED|95.0|-61.2|-40.1|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-40.1|-61.2|<0.001
71011550|NCT04516291|141530038|OTHER||LS Mean difference|-56.8|STANDARD_ERROR_OF_MEAN|6.14|<|0.001|TWO_SIDED|95.0|-68.9|-44.7|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-44.7|-68.9|<0.001
71011551|NCT04516291|141530038|OTHER||LS Mean difference|-15.1|STANDARD_ERROR_OF_MEAN|4.36|<|0.001|TWO_SIDED|95.0|-23.7|-6.5|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||-6.5|-23.7|<0.001
71047130|NCT00257920|141603526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.009||0.67||95.0|-0.023|0.015||No adjustment was made for multiple comparisons. A single hypothesis was tested by the primary efficacy analysis. All hypothesis tests were two-tailed and P-values \<= 0.050 were considered statistically significant.|Mixed Models Analysis|||The null hypothesis was that there is no difference in the mean calcium absorption fraction between Zemplar Injection and Hectorol Injection. The power calculation applied to the primary efficacy analysis.||0.015|-0.023|0.670
71011552|NCT04516291|141530038|OTHER||LS Mean difference|-10.6|STANDARD_ERROR_OF_MEAN|4.34||0.015|TWO_SIDED|95.0|-19.2|-2.1|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||-2.1|-19.2|0.015
71011553|NCT04516291|141530038|OTHER||LS Mean difference|-11.5|STANDARD_ERROR_OF_MEAN|4.49||0.011|TWO_SIDED|95.0|-20.3|-2.7|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||-2.7|-20.3|0.011
71011554|NCT04516291|141530038|OTHER||LS Mean difference|-12.5|STANDARD_ERROR_OF_MEAN|3.64|<|0.001|TWO_SIDED|95.0|-19.7|-5.3|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||-5.3|-19.7|<0.001
71011555|NCT04516291|141530038|OTHER||LS Mean difference|-12.6|STANDARD_ERROR_OF_MEAN|3.54|<|0.001|TWO_SIDED|95.0|-19.5|-5.6|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||-5.6|-19.5|<0.001
71011556|NCT04516291|141530038|OTHER||LS Mean difference|-6.0|STANDARD_ERROR_OF_MEAN|3.56||0.095|TWO_SIDED|95.0|-13.0|1.0|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||1.0|-13.0|0.095
71011557|NCT04516291|141530038|OTHER||LS Mean difference|-8.5|STANDARD_ERROR_OF_MEAN|4.01||0.036|TWO_SIDED|95.0|-16.4|-0.6|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||-0.6|-16.4|0.036
71011558|NCT04516291|141530038|OTHER||LS Mean difference|-10.0|STANDARD_ERROR_OF_MEAN|6.55||0.129|TWO_SIDED|95.0|-22.9|2.9|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||2.9|-22.9|0.129
71047131|NCT00257920|141603527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.009||0.573||95.0|-0.024|0.014||No adjustment was made for multiple comparisons. A single hypothesis was tested by the primary efficacy analysis. All hypothesis tests were two-tailed and P-values \<=0.050 were considered statistically significant.|ANOVA|||The null hypothesis was that there is no difference in mean calcium absorption between Zemplar and Hectorol. Approximately 42 subjects were to be randomized assuming 36 subjects would available in the per-protocol set. A sample size of 36 subjects has 80% power to detect a mean difference of -0.018 assuming the Zemplar group mean is 0.139, the Hectorol group mean is 0.157 and the STD is 0.037. The ANOVA model included effects for sequence, subject-within-sequence, period and treatment regimen.||0.014|-0.024|0.573
71047132|NCT03508687|141603528|OTHER|||||||0.517||||||paired t test; baseline vs. week 12 (n = 5)|t-test, 2 sided|||||||0.517
71047133|NCT03508687|141603528|OTHER|||||||0.345|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Signed Ranks Test (n = 5)||||||0.345
71047134|NCT00534794|141603566|SUPERIORITY_OR_OTHER|||||||0.532||95.0|||||ANCOVA|||ITT (Intent to Treat)||||0.532
71047135|NCT00534794|141603567|SUPERIORITY_OR_OTHER|||||||0.927||95.0|||||Student's t-test|||ITT (Intent to Treat)||||0.927
71047136|NCT02728752|141603571|SUPERIORITY||Mean Difference (Net)|-8.0|||<|0.0001|TWO_SIDED|95.0|-11.5|-4.6|||ANCOVA|With treatment, stratum and baseline as fixed effects, and site as random effect|Difference in LS Means of changes from baseline to week 16 (Octagam - Placebo)|LS Means difference between changes from baseline to week 16 for Total Activity Score||-4.6|-11.5|<0.0001
71103784|NCT02038647|141715031|SUPERIORITY||Odds Ratio (OR)|0.74||||0.406|TWO_SIDED|95.0|0.35|1.55||Stratification factors were disease subtypes (sensitive versus resistant/refractory), the presence of brain metastases and region.|Weighted Cochran-Mantel-Haenszel test||Logistic regression using ORR as dependent variable, treatment arm as independent variable and disease subtype (sensitive vs resistant/refractory) and presence of brain metastases as stratification factors.|||1.55|0.35|0.406
71103785|NCT02038647|141715032|SUPERIORITY||Odds Ratio (OR)|0.01||||0.283|TWO_SIDED|95.0|0.01|9999.99||Stratification factors were disease subtypes (sensitive versus resistant/refractory), the presence of brain metastases and region.|Weighted Cochran-Mantel-Haenszel test||Logistic regression using CRR as dependent variable, treatment arm as independent variable and disease subtype (sensitive vs resistant/refractory) and presence of brain metastases as stratification factors.|||9999.99|0.01|0.283
71047137|NCT02728752|141603577|SUPERIORITY||Median Difference (Net)|8.6||||0.0001|TWO_SIDED|95.0|4.4|12.8|||ANCOVA|With treatment, stratum and baseline as fixed effects, and site as random effect|Difference in LS Means of changes from baseline to week 16 (Octagam - Placebo)|LS Means difference between changes from baseline to week 16||12.8|4.4|0.0001
71047138|NCT02728752|141603578|SUPERIORITY||Median Difference (Net)|-0.4||||0.0002|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|With treatment, stratum and baseline as fixed effects, and site as random effect|Difference in LS Means of changes from baseline to week 16 (Octagam - Placebo)|LS Means difference between changes from baseline to week 16||-0.2|-0.5|0.0002
71047139|NCT02728752|141603584|SUPERIORITY||Median Difference (Net)|-1.2||||0.001|TWO_SIDED|95.0|-1.9|-0.5|||ANCOVA|With treatment, stratum and baseline as fixed effects, and site as random effect|Difference in LS Means of changes from baseline to week 16 (Octagam - Placebo)|LS Means difference between changes from baseline to week 16||-0.5|-1.9|0.0010
71047140|NCT03456960|141603599|EQUIVALENCE|The difference in the least square means (LSM) between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90 percent (%) confidence interval (CI) were provided using a crossover analysis of variance (ANOVA) model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0059|||||TWO_SIDED|90.0|-0.034|0.0458||||||||0.0458|-0.0340|
71011559|NCT04516291|141530038|OTHER||LS Mean difference|-7.9|STANDARD_ERROR_OF_MEAN|6.65||0.238|TWO_SIDED|95.0|-21.0|5.2|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||5.2|-21.0|0.238
71011560|NCT04516291|141530038|OTHER||LS Mean difference|-11.4|STANDARD_ERROR_OF_MEAN|6.73||0.09|TWO_SIDED|95.0|-24.7|1.8|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||1.8|-24.7|0.090
71011561|NCT04516291|141530038|OTHER||LS Mean difference|-16.0|STANDARD_ERROR_OF_MEAN|5.44||0.004|TWO_SIDED|95.0|-26.7|-5.3|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||-5.3|-26.7|0.004
71011562|NCT04516291|141530038|OTHER||LS Mean difference|-14.5|STANDARD_ERROR_OF_MEAN|5.38||0.008|TWO_SIDED|95.0|-25.1|-3.9|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||-3.9|-25.1|0.008
71047141|NCT03456960|141603600|EQUIVALENCE|The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0508|||||TWO_SIDED|90.0|-0.0079|0.1096||||||||0.1096|-0.0079|
71047142|NCT03456960|141603601|EQUIVALENCE|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0546|||||TWO_SIDED|90.0|-0.0941|0.2034||||||||0.2034|-0.0941|
71047143|NCT03456960|141603601|EQUIVALENCE|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model will include a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0912|||||TWO_SIDED|90.0|0.0399|0.1424||||||||0.1424|0.0399|
71047144|NCT03456960|141603602|EQUIVALENCE|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0916|||||TWO_SIDED|90.0|-0.133|0.3162||||||||0.3162|-0.1330|
71047145|NCT03456960|141603602|EQUIVALENCE|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.2293|||||TWO_SIDED|90.0|0.1519|0.3068||||||||0.3068|0.1519|
71047146|NCT03456960|141603603|EQUIVALENCE|The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.01|||||TWO_SIDED|90.0|-0.0299|0.05||||||||0.0500|-0.0299|
71047147|NCT03456960|141603604|EQUIVALENCE|The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.0281|||||TWO_SIDED|90.0|-0.1662|0.11||||||||0.1100|-0.1662|
71047148|NCT03456960|141603605|EQUIVALENCE|The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.015|||||TWO_SIDED|90.0|-0.0448|0.0149||||||||0.0149|-0.0448|
71047149|NCT03456960|141603606|EQUIVALENCE|The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.0195|||||TWO_SIDED|90.0|-0.0676|0.0286||||||||0.0286|-0.0676|
71047150|NCT03456960|141603607|EQUIVALENCE|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0547|||||TWO_SIDED|90.0|-0.0937|0.2032||||||||0.2032|-0.0937|
71047151|NCT03456960|141603607|EQUIVALENCE|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0654|||||TWO_SIDED|90.0|0.0141|0.1167||||||||0.1167|0.0141|
71047152|NCT03456960|141603608|EQUIVALENCE|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.146|||||TWO_SIDED|90.0|-0.2478|-0.0443||||||||-0.0443|-0.2478|
71103786|NCT02038647|141715033|SUPERIORITY||Odds Ratio (OR)|0.59||||0.077|TWO_SIDED|95.0|0.32|1.08||Stratification factors were disease subtypes (sensitive versus resistant/refractory), the presence of brain metastases and region.|Weighted Cochran-Mantel-Haenszel test||Logistic regression using DCR as dependent variable, treatment arm as independent variable and disease subtype (sensitive vs resistant/refractory) and presence of brain metastases as stratification factors.|||1.08|0.32|0.077
70941395|NCT02567227|141383484|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-0.91|0.43|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in stride length variability during normal walking pre and post intervention.||0.43|-0.91|
71103787|NCT05852340|141715106|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|102.36|||||TWO_SIDED|90.0|95.81|109.35||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Mixed with Strawberry Jam (Fasted)||109.35|95.81|
71103788|NCT05852340|141715106|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|97.15|||||TWO_SIDED|90.0|90.94|103.79||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Mixed with Yoghurt (Fasted)||103.79|90.94|
70928668|NCT04800211|141353082|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-1.085|||<|0.0001|TWO_SIDED|95.0|-1.736|-0.435|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.435|-1.736|<.0001
70928669|NCT04800211|141353082|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-1.112|||<|0.0001|TWO_SIDED|95.0|-1.532|-0.693|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.693|-1.532|<.0001
71047153|NCT03456960|141603608|EQUIVALENCE|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.1674|||||TWO_SIDED|90.0|-0.2084|-0.1264||||||||-0.1264|-0.2084|
71047154|NCT03456960|141603609|EQUIVALENCE|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.1193|||||TWO_SIDED|90.0|-0.2179|-0.0206||||||||-0.0206|-0.2179|
70928670|NCT04800211|141353082|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.054||||0.8248|TWO_SIDED|95.0|-0.535|0.427|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.427|-0.535|0.8248
70928671|NCT04800211|141353083|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|2.821||||0.0002|TWO_SIDED|95.0|1.369|4.273|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||4.273|1.369|0.0002
70928672|NCT04800211|141353083|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|3.468|||<|0.0001|TWO_SIDED|95.0|1.85|5.086|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||5.086|1.850|<.0001
70941396|NCT02567227|141383484|SUPERIORITY||Mean Difference (Net)|-0.44|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-1.16|0.27|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in stride length variability during walking while talking pre and post intervention.||0.27|-1.16|
71103789|NCT05852340|141715106|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|99.65|||||TWO_SIDED|90.0|93.28|106.46||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Mixed with Applesauce (Fasted)||106.46|93.28|
70928673|NCT04800211|141353083|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|2.245||||0.0022|TWO_SIDED|95.0|0.812|3.679|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||3.679|0.812|0.0022
71103790|NCT05852340|141715106|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|104.84|||||TWO_SIDED|90.0|97.3|112.96||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Given with High Fat Meal||112.96|97.30|
70928674|NCT04800211|141353083|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|3.329|||<|0.0001|TWO_SIDED|95.0|1.768|4.891|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||4.891|1.768|<.0001
70928675|NCT04800211|141353083|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|3.399|||<|0.0001|TWO_SIDED|95.0|2.252|4.545|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||4.545|2.252|<.0001
70928676|NCT04800211|141353083|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|1.25||||0.0761|TWO_SIDED|95.0|-0.132|2.633|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||2.633|-0.132|0.0761
70928677|NCT04800211|141353083|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.778||||0.0211|TWO_SIDED|95.0|0.269|3.286|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||3.286|0.269|0.0211
70928678|NCT04800211|141353083|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|1.57||||0.3841|TWO_SIDED|95.0|-0.951|4.092|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||4.092|-0.951|0.3841
70928679|NCT04800211|141353083|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.69||||0.3934|TWO_SIDED|95.0|-1.084|4.464|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||4.464|-1.084|0.3934
71103791|NCT05852340|141715107|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|96.63|||||TWO_SIDED|90.0|83.66|111.62||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Mixed with Strawberry Jam (Fasted)||111.62|83.66|
71011563|NCT04516291|141530038|OTHER||LS Mean difference|-7.9|STANDARD_ERROR_OF_MEAN|5.28||0.136|TWO_SIDED|95.0|-18.3|2.5|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||2.5|-18.3|0.136
71011564|NCT04516291|141530038|OTHER||LS Mean difference|-9.0|STANDARD_ERROR_OF_MEAN|6.01||0.138|TWO_SIDED|95.0|-20.8|2.9|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||2.9|-20.8|0.138
71011565|NCT04516291|141530040|OTHER||LS Mean difference|-69.9|STANDARD_ERROR_OF_MEAN|5.97|<|0.001|TWO_SIDED|95.0|-81.6|-58.1|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-58.1|-81.6|<0.001
71011566|NCT04516291|141530040|OTHER||LS Mean difference|-79.6|STANDARD_ERROR_OF_MEAN|6.03|<|0.001|TWO_SIDED|95.0|-91.5|-67.7|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-67.7|-91.5|<0.001
71011567|NCT04516291|141530040|OTHER||LS Mean difference|-77.1|STANDARD_ERROR_OF_MEAN|6.22|<|0.001|TWO_SIDED|95.0|-89.4|-64.9|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-64.9|-89.4|<0.001
71047155|NCT03456960|141603609|EQUIVALENCE|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.1366|||||TWO_SIDED|90.0|-0.173|-0.1002||||||||-0.1002|-0.1730|
71047156|NCT03456960|141603610|EQUIVALENCE|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0148|||||TWO_SIDED|90.0|-0.0734|0.103||||||||0.1030|-0.0734|
70941397|NCT02567227|141383485|SUPERIORITY||Mean Difference (Net)|-0.16|||||TWO_SIDED|95.0|-0.51|0.19|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the pace domain during normal pace walking pre and post intervention.||0.19|-0.51|
71011568|NCT04516291|141530040|OTHER||LS Mean difference|-86.3|STANDARD_ERROR_OF_MEAN|5.04|<|0.001|TWO_SIDED|95.0|-96.2|-76.3|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-76.3|-96.2|<0.001
71011569|NCT04516291|141530040|OTHER||LS Mean difference|-80.4|STANDARD_ERROR_OF_MEAN|4.82|<|0.001|TWO_SIDED|95.0|-89.9|-70.9|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-70.9|-89.9|<0.001
71011570|NCT04516291|141530040|OTHER||LS Mean difference|-92.2|STANDARD_ERROR_OF_MEAN|4.92|<|0.001|TWO_SIDED|95.0|-101.9|-82.6|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-82.6|-101.9|<0.001
71011571|NCT04516291|141530040|OTHER||LS Mean difference|-95.2|STANDARD_ERROR_OF_MEAN|5.59|<|0.001|TWO_SIDED|95.0|-106.2|-84.2|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-84.2|-106.2|<0.001
71011572|NCT02181634|141530061|SUPERIORITY||Hazard Ratio (HR)|2.02||||0.099|TWO_SIDED|95.0|0.86|4.75|||Log Rank|||||4.75|0.86|0.099
71011573|NCT02181634|141530062|SUPERIORITY||Hazard Ratio (HR)|1.54||||0.34|TWO_SIDED|95.0|0.64|3.71|||Log Rank|||||3.71|0.64|0.34
71011574|NCT02145949|141530069|OTHER|||||||0.03|||||||ANCOVA|||||||.03
71011575|NCT02145949|141530070|OTHER|||||||0.01|||||||ANCOVA|||||||.01
71011576|NCT02145949|141530071|OTHER|||||||0.04|||||||ANCOVA|||||||.04
71011577|NCT02145949|141530072|OTHER|||||||0.01|||||||ANCOVA|||||||.01
71011578|NCT02145949|141530073|OTHER|||||||0.12|||||||ANCOVA|||||||.12
71011579|NCT02145949|141530074|OTHER|||||||0.03|||||||ANCOVA|||||||.03
71011580|NCT02145949|141530075|OTHER|||||||0.71|||||||ANCOVA|||||||.71
71011581|NCT02145949|141530076|OTHER|||||||0.76|||||||ANCOVA|||||||.76
71011582|NCT02145949|141530077|OTHER|||||||0.4|||||||ANCOVA|||||||.40
71011583|NCT02145949|141530078|OTHER|||||||0.97|||||||ANCOVA|||||||.97
71011584|NCT02145949|141530079|OTHER|||||||0.89|||||||ANCOVA|||||||.89
71011585|NCT02145949|141530080|OTHER|||||||0.48|||||||ANCOVA|||||||.48
71011586|NCT02145949|141530081|OTHER|||||||0.02|||||||ANCOVA|||||||.02
71011587|NCT02145949|141530082|OTHER|||||||0.29|||||||ANCOVA|||||||.29
71011588|NCT02145949|141530083|OTHER|||||||0.33|||||||ANCOVA|||||||.33
71011589|NCT02145949|141530084|OTHER|||||||0.3|||||||ANCOVA|||||||.30
71011590|NCT02145949|141530085|OTHER|||||||0.98|||||||ANCOVA|||||||.98
71011591|NCT02145949|141530086|OTHER|||||||0.18|||||||ANCOVA|||||||.18
71011592|NCT02145949|141530087|OTHER|||||||0.52|||||||ANCOVA|||||||.52
71011593|NCT02145949|141530088|OTHER|||||||0.81|||||||ANCOVA|||||||.81
71011594|NCT02843282|141530091|SUPERIORITY||Mean Difference (Net)|0.69||||0.04|TWO_SIDED||||||Regression, Linear|||||||0.040
71011595|NCT02843282|141530092|SUPERIORITY||Mean Difference (Net)|0.98||||0.004|TWO_SIDED||||||Regression, Linear|||||||0.004
71011596|NCT02843282|141530093|SUPERIORITY||Mean Difference (Net)|1.95|||<|0.001|TWO_SIDED||||||Regression, Linear|||||||<0.001
71011597|NCT02843282|141530094|SUPERIORITY||Mean Difference (Net)|0.52||||0.039|TWO_SIDED||||||Regression, Linear|||||||0.039
71011598|NCT02843282|141530095|SUPERIORITY||Mean Difference (Net)|0.42||||0.092|TWO_SIDED||||||Regression, Linear|||||||0.092
71011599|NCT02843282|141530096|SUPERIORITY||Mean Difference (Net)|6.58||||0.052|TWO_SIDED||||||Regression, Linear|||||||0.052
71011600|NCT02843282|141530097|SUPERIORITY||Mean Difference (Net)|0.52||||0.121|TWO_SIDED||||||Regression, Linear|||||||0.121
71011601|NCT02843282|141530098|SUPERIORITY||Mean Difference (Net)|1.23||||0.019|TWO_SIDED||||||Regression, Linear|||||||0.019
71011602|NCT02843282|141530099|SUPERIORITY||Mean Difference (Net)|0.37||||0.278|TWO_SIDED||||||Regression, Linear|||||||0.278
71011603|NCT02843282|141530100|SUPERIORITY||Mean Difference (Net)|7.0||||0.095|TWO_SIDED||||||Regression, Linear|||||||0.095
71047157|NCT03456960|141603610|EQUIVALENCE|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.002|||||TWO_SIDED|90.0|-0.0463|0.0424||||||||0.0424|-0.0463|
71011604|NCT02843282|141530101|OTHER||Mean Difference (Net)|0.15|||<|0.01|TWO_SIDED||||||Whole brain voxel-wise correlation analy|||||||< 0.01
71011605|NCT02843282|141530102|SUPERIORITY||Mean Difference (Net)|1.22||||0.001|TWO_SIDED||||||Regression, Linear|||||||0.001
71011606|NCT02843282|141530103|SUPERIORITY||Mean Difference (Net)|1.33||||0.007|TWO_SIDED||||||Regression, Linear|||||||0.007
71011607|NCT04550234|141530104|OTHER||Geometric mean ratio|57.73|||||TWO_SIDED|90.0|47.07|70.81||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||70.81|47.07|
71011608|NCT04550234|141530104|OTHER||Geometric mean ratio|145.55|||||TWO_SIDED|90.0|118.66|178.52||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||178.52|118.66|
71011609|NCT04550234|141530104|OTHER||Geometric mean ratio|52.07|||||TWO_SIDED|90.0|42.46|63.87||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||63.87|42.46|
71011610|NCT04550234|141530104|OTHER||Geometric mean ratio|101.16|||||TWO_SIDED|90.0|82.48|124.08||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||124.08|82.48|
71011611|NCT04550234|141530104|OTHER||Geometric mean ratio|73.34|||||TWO_SIDED|90.0|61.81|87.03||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||87.03|61.81|
71011612|NCT04550234|141530104|OTHER||Geometric mean ratio|66.33|||||TWO_SIDED|90.0|55.9|78.72||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||78.72|55.90|
71011613|NCT04550234|141530104|OTHER||Geometric mean ratio|106.58|||||TWO_SIDED|90.0|89.81|126.47||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||126.47|89.81|
71011614|NCT04550234|141530104|OTHER||Geometric mean ratio|86.86|||||TWO_SIDED|90.0|83.15|90.74||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||90.74|83.15|
71011615|NCT04550234|141530104|OTHER||Geometric mean ratio|92.3|||||TWO_SIDED|90.0|88.35|96.42||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||96.42|88.35|
71011616|NCT04550234|141530104|OTHER||Geometric mean ratio|89.54|||||TWO_SIDED|90.0|85.71|93.54||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||93.54|85.71|
71011617|NCT04550234|141530105|OTHER||Geometric mean ratio|102.49|||||TWO_SIDED|90.0|89.12|117.86||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||117.86|89.12|
71011618|NCT04550234|141530105|OTHER||Geometric mean ratio|144.61|||||TWO_SIDED|90.0|125.75|166.31||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||166.31|125.75|
71011619|NCT04550234|141530105|OTHER||Geometric mean ratio|76.72|||||TWO_SIDED|90.0|66.71|88.23||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||88.23|66.71|
71011620|NCT04550234|141530105|OTHER||Geometric mean ratio|96.19|||||TWO_SIDED|90.0|83.64|110.62||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||110.62|83.64|
71011621|NCT04550234|141530105|OTHER||Geometric mean ratio|89.41|||||TWO_SIDED|90.0|83.86|95.34||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||95.34|83.86|
71011622|NCT04550234|141530105|OTHER||Geometric mean ratio|94.16|||||TWO_SIDED|90.0|88.31|100.4||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||100.40|88.31|
71011623|NCT04550234|141530105|OTHER||Geometric mean ratio|91.7|||||TWO_SIDED|90.0|86.37|97.36||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||97.36|86.37|
70928680|NCT04800211|141353083|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|0.995||||0.7782|TWO_SIDED|95.0|-1.505|3.494|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||3.494|-1.505|0.7782
70928681|NCT04800211|141353083|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.552||||0.4576|TWO_SIDED|95.0|-1.171|4.274|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||4.274|-1.171|0.4576
70928682|NCT04800211|141353083|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.621||||0.0849|TWO_SIDED|95.0|-0.224|3.466|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||3.466|-0.224|0.0849
70928683|NCT04800211|141353083|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.139||||0.9016|TWO_SIDED|95.0|-2.064|2.341|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||2.341|-2.064|0.9016
71011624|NCT04550234|141530105|OTHER||Geometric mean ratio|91.23|||||TWO_SIDED|90.0|88.01|94.56||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||94.56|88.01|
71047158|NCT03456960|141603611|EQUIVALENCE|TAK-438F: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.2138|||||TWO_SIDED|90.0|0.1609|0.2667||||||||0.2667|0.1609|
71103792|NCT05852340|141715107|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|84.58|||||TWO_SIDED|90.0|73.23|97.7||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Mixed with Yoghurt (Fasted)||97.70|73.23|
71103793|NCT05852340|141715107|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|93.91|||||TWO_SIDED|90.0|81.3|108.48||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Mixed with Applesauce (Fasted)||108.48|81.30|
70928684|NCT04800211|141353084|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|5.587||||0.0004|TWO_SIDED|95.0|2.511|8.662|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||8.662|2.511|0.0004
71011625|NCT04550234|141530105|OTHER||Geometric mean ratio|99.95|||||TWO_SIDED|90.0|96.43|103.61||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||103.61|96.43|
71011626|NCT04550234|141530105|OTHER||Geometric mean ratio|90.13|||||TWO_SIDED|90.0|86.95|93.42||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||93.42|86.95|
71011627|NCT04550234|141530106|OTHER||Geometric mean ratio|102.91|||||TWO_SIDED|90.0|89.04|118.93||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||118.93|89.04|
71011628|NCT04550234|141530106|OTHER||Geometric mean ratio|146.57|||||TWO_SIDED|90.0|126.82|169.4||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||169.40|126.82|
71011629|NCT04550234|141530106|OTHER||Geometric mean ratio|76.72|||||TWO_SIDED|90.0|66.38|88.67||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||88.67|66.38|
71011630|NCT04550234|141530106|OTHER||Geometric mean ratio|95.37|||||TWO_SIDED|90.0|82.52|110.23||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||110.23|82.52|
71011631|NCT04550234|141530106|OTHER||Geometric mean ratio|82.6|||||TWO_SIDED|90.0|77.38|88.17||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||88.17|77.38|
71047159|NCT03456960|141603612|EQUIVALENCE|TAK-438F: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.2161|||||TWO_SIDED|90.0|0.1652|0.2671||||||||0.2671|0.1652|
71047160|NCT03456960|141603613|EQUIVALENCE|TAK-438F: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.219|||||TWO_SIDED|90.0|0.1675|0.2706||||||||0.2706|0.1675|
71047161|NCT03456960|141603614|EQUIVALENCE|TAK-438F: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.3653|||||TWO_SIDED|90.0|0.218|0.5126||||||||0.5126|0.2180|
71047162|NCT03456960|141603617|EQUIVALENCE|Unchanged aspirin: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.2089|||||TWO_SIDED|90.0|-0.0061|0.4239||||||||0.4239|-0.0061|
71011632|NCT04550234|141530106|OTHER||Geometric mean ratio|87.14|||||TWO_SIDED|90.0|81.63|93.01||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||93.01|81.63|
71011633|NCT04550234|141530106|OTHER||Geometric mean ratio|91.45|||||TWO_SIDED|90.0|85.67|97.61||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||97.61|85.67|
71011634|NCT04550234|141530106|OTHER||Geometric mean ratio|90.91|||||TWO_SIDED|90.0|87.98|93.94||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||93.94|87.98|
71011635|NCT04550234|141530106|OTHER||Geometric mean ratio|99.37|||||TWO_SIDED|90.0|96.17|102.68||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||102.68|96.17|
71011636|NCT04550234|141530106|OTHER||Geometric mean ratio|89.18|||||TWO_SIDED|90.0|86.3|92.15||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||92.15|86.30|
71011637|NCT04550234|141530118|OTHER||Geometric mean ratio|108.25|||||TWO_SIDED|90.0|94.13|124.49||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||124.49|94.13|
71011638|NCT04550234|141530118|OTHER||Geometric mean ratio|96.57|||||TWO_SIDED|90.0|90.96|102.53||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||102.53|90.96|
71011639|NCT04550234|141530118|OTHER||Geometric mean ratio|98.75|||||TWO_SIDED|90.0|95.27|102.36||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||102.36|95.27|
71011640|NCT04550234|141530119|OTHER||Geometric mean ratio|109.27|||||TWO_SIDED|90.0|94.55|126.29||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||126.29|94.55|
71011641|NCT04550234|141530119|OTHER||Geometric mean ratio|96.47|||||TWO_SIDED|90.0|90.38|102.97||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||102.97|90.38|
71011642|NCT04550234|141530119|OTHER||Geometric mean ratio|97.48|||||TWO_SIDED|90.0|94.34|100.73||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||100.73|94.34|
71011643|NCT04550234|141530120|OTHER||Geometric mean ratio|131.28|||||TWO_SIDED|90.0|107.03|161.02||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||161.02|107.03|
70928685|NCT04800211|141353084|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|2.556||||0.1141|TWO_SIDED|95.0|-0.62|5.732|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||5.732|-0.620|0.1141
70941398|NCT02567227|141383485|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.2|0.41|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the rhythm domain during normal pace walking pre and post intervention.||0.41|-0.20|
71011644|NCT04550234|141530120|OTHER||Geometric mean ratio|96.39|||||TWO_SIDED|90.0|81.23|114.39||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||114.39|81.23|
71011645|NCT04550234|141530120|OTHER||Geometric mean ratio|95.15|||||TWO_SIDED|90.0|91.08|99.4||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||99.40|91.08|
71011646|NCT01928758|141530121|OTHER||Mean Difference (Final Values)|-175.7|||<|0.0001|TWO_SIDED|95.0|-218.3|-133.1||Complete case analysis|Regression, Linear|Model was adjusted for baseline cotinine after smoking usual nicotine content cigarettes for 2-weeks.|The direction of comparison is reduced nicotine content vs. usual nicotine content cigarette treatment group.|||-133.1|-218.3|<0.0001
71011647|NCT01928758|141530122|OTHER||Mean Difference (Final Values)|0.69||||0.16|TWO_SIDED|95.0|-0.28|1.65||Complete case analysis|Regression, Linear|Model was adjusted for baseline score after smoking usual nicotine content cigarettes for 2 weeks|The direction of comparison is reduced nicotine content vs. usual nicotine content cigarette treatment group|||1.65|-0.28|0.16
71011648|NCT01928758|141530123|OTHER||Mean Difference (Final Values)|0.38||||0.67|TWO_SIDED|95.0|-1.4|2.16||Complete case analysis|Regression, Linear|Model was adjusted for baseline score after smoking usual nicotine content cigarettes for 2 weeks|The direction of comparison is reduced nicotine content vs. usual nicotine content cigarette treatment group.|||2.16|-1.40|0.67
71011649|NCT01928758|141530124|OTHER||Mean Difference (Final Values)|-0.31||||0.65|TWO_SIDED|95.0|-1.68|1.05||Complete case analysis|Regression, Linear|Model was adjusted for baseline score after smoking usual nicotine content cigarettes for 2 weeks|The direction of comparison is reduced nicotine content vs. usual nicotine content cigarette treatment group|||1.05|-1.68|0.65
71047163|NCT03456960|141603617|EQUIVALENCE|Salicylic acid: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.014|||||TWO_SIDED|90.0|-0.0639|0.0918||||||||0.0918|-0.0639|
71103794|NCT05852340|141715107|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|43.83|||||TWO_SIDED|90.0|37.5|51.23||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Given with High Fat Meal||51.23|37.50|
71011650|NCT00134563|141530159|SUPERIORITY_OR_OTHER||Relative risk reduction (%)|31.5||||0.0005||||||"Step down approach used to adjust for multiplicity:~* H1 tested first~* H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance for both comparisons ≤0.05"|Regression, Poisson||Relative risk reduction with Teriflunomide 14 mg compared to placebo|"Null hypothesis:~* H1: No difference between Teriflunomide 14 mg and placebo~* H2: No difference between Teriflunomide 7 mg and placebo~The study was sized to detect a 25% relative risk reduction with teriflunomide in the 2-year relapse rate at a significance level of 0.050 with a power ≥95% anticipating a potential 20% 2-year dropout rate."||||0.0005
71011651|NCT00134563|141530159|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|31.2||||0.0002||||||"Step down approach used to adjust for multiplicity:~* H1 tested first~* H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance for both comparisons ≤0.05"|Regression, Poisson||Relative risk reduction with Teriflunomide 7 mg compared to placebo|||||0.0002
71011652|NCT00134563|141530160|SUPERIORITY_OR_OTHER||Hazard ratio reduction (%)|29.8||||0.0279||||||"Step down approach:~* H1 tested only if both comparisons on the primary outcome measure were statistically significant~* H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance ≤0.05"|Log Rank|Two-sided Log-rank test stratified by region of enrollment and baseline EDSS stratum|Relative risk reduction with Teriflunomide 14 mg compared to placebo (estimated from a Cox proportional hazard model with treatment arm, region of enrollment and baseline EDSS stratum as covariates)|"Null hypothesis:~* H1: No difference between Teriflunomide 14 mg and placebo~* H2: No difference between Teriflunomide 7 mg and placebo~The study was also sized to detect a 37% hazard rate reduction of an assumed disability progression hazard rate of 0.1783 in the placebo group and 0.1116 in the teriflunomide group by the end of 2 years with a power of 80% anticipating a potential 20% 2-year dropout rate."||||0.0279
71047164|NCT03456960|141603618|EQUIVALENCE|Unchanged aspirin: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.2099|||||TWO_SIDED|90.0|-0.0048|0.4246||||||||0.4246|-0.0048|
71103795|NCT01903863|141715110|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
71103796|NCT01903863|141715111|SUPERIORITY|||||||0.07||||||Intracranial hemorrhage|Fisher Exact|||||||0.07
71103797|NCT01903863|141715111|SUPERIORITY|||||||0.7||||||Surgical bleed|Fisher Exact|||||||0.7
71103798|NCT01903863|141715111|SUPERIORITY|||||||0.5||||||Gastrointestinal hemorrhage|Fisher Exact|||||||0.5
71103799|NCT01903863|141715112|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
71103800|NCT01903863|141715113|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
71011653|NCT00134563|141530160|SUPERIORITY_OR_OTHER||Hazard ratio reduction (%)|23.7||||0.0835||||||"Step down approach:~* H1 tested only if both comparisons on the primary outcome measure were statistically significant~* H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance ≤0.05"|Log Rank|Two-sided Log-rank test stratified by region of enrollment and baseline EDSS stratum|Relative risk reduction with Teriflunomide 7 mg compared to placebo (estimated from a Cox proportional hazard model with treatment arm, region of enrollment and baseline EDSS stratum as covariates)|||||0.0835
71011654|NCT00134563|141530161|SUPERIORITY_OR_OTHER|||||||0.0003||95.0||||"A priori threshold for statistical significance ≤0.05~No adjustment for multiple comparisons"|t-test, 2 sided|2-sided t-test on baseline adjusted least-square means||Mixed-effect model with repeated measures \[MMRM\] on cubic root transformed total lesion volume data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value (cubic root transformed) and baseline-by-visit interaction).||||0.0003
71047165|NCT03456960|141603618|EQUIVALENCE|Salicylic acid: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.0137|||||TWO_SIDED|90.0|-0.0712|0.0986||||||||0.0986|-0.0712|
71047166|NCT03456960|141603619|EQUIVALENCE|Unchanged aspirin: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.2096|||||TWO_SIDED|90.0|-0.0054|0.4246||||||||0.4246|-0.0054|
71047167|NCT03456960|141603619|EQUIVALENCE|Salicylic acid: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.0201|||||TWO_SIDED|90.0|-0.069|0.1092||||||||0.1092|-0.0690|
71047168|NCT03456960|141603620|EQUIVALENCE|Unchanged aspirin: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.4058|||||TWO_SIDED|90.0|0.0803|0.7312||||||||0.7312|0.0803|
71047169|NCT03456960|141603620|EQUIVALENCE|Salicylic acid: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.1969|||||TWO_SIDED|90.0|0.1065|0.2873||||||||0.2873|0.1065|
71047170|NCT00653991|141603630|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
71103801|NCT01903863|141715114|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
71103802|NCT01903863|141715115|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
71103803|NCT01903863|141715116|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
71103804|NCT01903863|141715117|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
71103805|NCT01892189|141715122|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-0.2348|STANDARD_ERROR_OF_MEAN|0.20458||0.259|TWO_SIDED|95.0|-0.6506|0.1809|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Anterior Cingulate Cortex: Values were obtained using analysis of variance (ANOVA) model with sequence, period, regimen and participant nested within sequence as factors by regions of interest.||0.1809|-0.6506|0.259
71103806|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0367|STANDARD_ERROR_OF_MEAN|0.22075||0.869|TWO_SIDED|95.0|-0.4853|0.4119|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.4119|-0.4853|0.869
71103807|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.218|STANDARD_ERROR_OF_MEAN|0.20968||0.306|TWO_SIDED|95.0|-0.6441|0.2081|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2081|-0.6441|0.306
71103808|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2525|STANDARD_ERROR_OF_MEAN|0.17956||0.169|TWO_SIDED|95.0|-0.6174|0.1124|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1124|-0.6174|0.169
70928686|NCT04800211|141353084|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|5.536||||0.0007|TWO_SIDED|95.0|2.367|8.705|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||8.705|2.367|0.0007
70928687|NCT04800211|141353084|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|6.629|||<|0.0001|TWO_SIDED|95.0|3.68|9.577|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||9.577|3.680|<.0001
70928688|NCT04800211|141353084|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|4.083||||0.0072|TWO_SIDED|95.0|1.118|7.047|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||7.047|1.118|0.0072
70928689|NCT04800211|141353084|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|4.688||||0.0023|TWO_SIDED|95.0|1.691|7.686|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||7.686|1.691|0.0023
70928690|NCT04800211|141353084|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|5.112|||<|0.0001|TWO_SIDED|95.0|2.874|7.35|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||7.350|2.874|<.0001
71011655|NCT00134563|141530161|SUPERIORITY_OR_OTHER|||||||0.0317||||||"A priori threshold for statistical significance ≤0.05~No adjustment for multiple comparisons"|t-test, 2 sided|2-sided t-test on baseline adjusted least-square means||Mixed-effect model with repeated measures \[MMRM\] on cubic root transformed total lesion volume data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value (cubic root transformed) and baseline-by-visit interaction).||||0.0317
71011656|NCT00134563|141530164|SUPERIORITY_OR_OTHER|||||||0.8271||||||"A priori threshold for statistical significance ≤0.05~No adjustment for multiple comparisons"|t-test, 2 sided|2-sided t-test on baseline adjusted least-square means||||||0.8271
71011657|NCT00134563|141530164|SUPERIORITY_OR_OTHER|||||||0.3861||||||"A priori threshold for statistical significance ≤0.05~No adjustment for multiple comparisons"|t-test, 2 sided|2-sided t-test on baseline adjusted least-square means||||||0.3861
70941399|NCT02567227|141383485|SUPERIORITY||Mean Difference (Net)|-0.11|||||TWO_SIDED|95.0|-0.53|0.32|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the variation domain during normal pace walking pre and post intervention.||0.32|-0.53|
71011658|NCT03382639|141530169|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.66||0.426|TWO_SIDED|95.0|-1.4|1.2|||Mixed Models Analysis|||||1.2|-1.4|0.426
71047171|NCT02037165|141603641|SUPERIORITY_OR_OTHER||adjusted mean difference|1.12|STANDARD_ERROR_OF_MEAN|2.0801|||TWO_SIDED|95.0|-3.0|5.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||5.2|-3.0|
71047172|NCT02037165|141603641|SUPERIORITY_OR_OTHER||adjusted mean difference|2.66|STANDARD_ERROR_OF_MEAN|2.0796|||TWO_SIDED|95.0|-1.4|6.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||6.8|-1.4|
71047173|NCT02037165|141603641|SUPERIORITY_OR_OTHER||adjusted mean difference|3.0|STANDARD_ERROR_OF_MEAN|2.0792|||TWO_SIDED|95.0|-1.1|7.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||7.1|-1.1|
71047174|NCT02037165|141603641|SUPERIORITY_OR_OTHER||adjusted mean difference|2.53|STANDARD_ERROR_OF_MEAN|2.079|||TWO_SIDED|95.0|-1.6|6.6|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||6.6|-1.6|
71047175|NCT02037165|141603641|SUPERIORITY_OR_OTHER||adjusted mean difference|1.72|STANDARD_ERROR_OF_MEAN|2.0789|||TWO_SIDED|95.0|-2.4|5.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||5.8|-2.4|
71047176|NCT02037165|141603641|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.15|STANDARD_ERROR_OF_MEAN|2.079|||TWO_SIDED|95.0|-4.2|3.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.9|-4.2|
71047177|NCT02037165|141603641|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.15|STANDARD_ERROR_OF_MEAN|2.0792|||TWO_SIDED|95.0|-7.2|0.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.9|-7.2|
71011659|NCT03382639|141530169|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.66||0.725|TWO_SIDED|95.0|-1.5|1.1|||Mixed Models Analysis|||||1.1|-1.5|0.725
71011660|NCT03382639|141530169|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.68||0.808|TWO_SIDED|95.0|-0.7|1.9|||Mixed Models Analysis|||||1.9|-0.7|0.808
71011661|NCT00148109|141530232|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher Exact|||Estimate a 4 month progression-free survival rate for each group.||||<0.05
71011662|NCT00649220|141530235|SUPERIORITY_OR_OTHER|||||||0.22626||95.0|||||t-test, 2 sided|||Two-side, paired t-test on the null hypothesis that antipsychotics are reduced by 10% compared to baseline||||0.22626
71011663|NCT00649220|141530235|SUPERIORITY_OR_OTHER|||||||0.34192||95.0|||||Wilcoxon signed rank test|||Wilcoxon signed rank test on the null hypothesis that antipsychotics are reduced by 10% compared to baseline||||0.34192
70928691|NCT04800211|141353084|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.777||||0.603|TWO_SIDED|95.0|-2.165|3.72|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.720|-2.165|0.6030
70928692|NCT04800211|141353084|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.003||||0.5053|TWO_SIDED|95.0|-1.96|3.967|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.967|-1.960|0.5053
70928693|NCT04800211|141353084|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.674||||0.6607|TWO_SIDED|95.0|-2.347|3.694|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.694|-2.347|0.6607
70928694|NCT04800211|141353084|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|4.809||||0.1309|TWO_SIDED|95.0|-0.827|10.446|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||10.446|-0.827|0.1309
70928695|NCT04800211|141353084|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.553||||0.9776|TWO_SIDED|95.0|-4.212|7.318|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||7.318|-4.212|0.9776
71011664|NCT01399619|141530243|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-value corresponds to a two sided test against the historical rate of 40%.|normal approximation|||the SVR12 rate in total Faldaprevir group compared with the historical rate of 40%.||||<0.0001
71011665|NCT00351611|141530277|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI bound was less than 0.10 (10%).|Difference in percentage of participants|-1.7094|||||TWO_SIDED|95.0|-9.1751|5.9784||||||A 2-sided 95 percent (%) confidence interval (CI) on the difference in percentage of participants, between pregabalin and placebo was constructed using unconditional exact methods.||5.9784|-9.1751|
71047178|NCT02037165|141603641|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.31|STANDARD_ERROR_OF_MEAN|2.0796|||TWO_SIDED|95.0|-5.4|2.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.8|-5.4|
70941400|NCT02567227|141383485|SUPERIORITY||Mean Difference (Net)|0.14|||||TWO_SIDED|95.0|-0.27|0.56|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the pace domain during walking while talking pre and post intervention.||0.56|-0.27|
71011666|NCT00351611|141530278|NON_INFERIORITY|Non-inferiority with respect to mean deviation was demonstrated if the lower bound of the CI is greater than -2.0 decibels.|Difference in LS mean|-0.125||||0.4414|TWO_SIDED|95.0|-0.443|0.194|||ANCOVA|||Analysis of covariance (ANCOVA) with treatment and center in the model and the baseline mean deviation as the covariate was used to construct a 2-sided 95% CI on the difference in least squares (LS) mean between pregabalin and placebo.||0.194|-0.443|0.4414
71011667|NCT00351611|141530279|OTHER||Difference in LS mean|-0.9||||0.1346|TWO_SIDED|95.0|-2.083|0.283|||ANCOVA|||ANCOVA with treatment and center in the model and the baseline visual acuity as the covariate was used to construct a 2-sided 95% confidence interval on the difference in LS mean between pregabalin and placebo.||0.283|-2.083|0.1346
71011668|NCT00368069|141530285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.155||||0.038||95.0|0.009|0.301|||ANCOVA|Analysis of covariance (ANCOVA) on (log-) POS freq/week over Treatment period with Treatment, (log-) Baseline POS freq/week as covariate.||||0.301|0.009|0.038
71011669|NCT00368069|141530285|SUPERIORITY_OR_OTHER_LEGACY||Percent reduction over Placebo|14.4||||||95.0|0.9|26.0|||Transf. of ANCOVA results on log data|Percent Reduction of Keppra over PBO is calculated based on the ANCOVA on log data as 100\*(1-exp(LSmeans Keppra -LSMeans Placebo))||Treatment difference was assessed through the percent reduction in POS freq/week of Keppra over Placebo by back transformation of the results of the ANCOVA on log data||26.0|0.9|
71047179|NCT02037165|141603641|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.15|STANDARD_ERROR_OF_MEAN|2.0801|||TWO_SIDED|95.0|-4.2|3.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.9|-4.2|
71047180|NCT02037165|141603641|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.68|STANDARD_ERROR_OF_MEAN|2.0282|||TWO_SIDED|95.0|-6.7|1.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.3|-6.7|
71047181|NCT02037165|141603641|SUPERIORITY_OR_OTHER||adjusted mean difference|1.58|STANDARD_ERROR_OF_MEAN|2.0279|||TWO_SIDED|95.0|-2.4|5.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||5.6|-2.4|
71047182|NCT02037165|141603641|SUPERIORITY_OR_OTHER||adjusted mean difference|2.63|STANDARD_ERROR_OF_MEAN|2.0278|||TWO_SIDED|95.0|-1.4|6.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||6.6|-1.4|
71047183|NCT02037165|141603641|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.17|STANDARD_ERROR_OF_MEAN|2.0277|||TWO_SIDED|95.0|-4.2|3.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.8|-4.2|
71011670|NCT00368069|141530287|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.158||||0.034||95.0|0.012|0.305|||ANCOVA|ANCOVA on (log-) seizure frequency per week over Treatment period with Treatment, (log-) Baseline seizure frequency per week as covariate.||||0.305|0.012|0.034
71011671|NCT00368069|141530287|SUPERIORITY_OR_OTHER_LEGACY||Percent reduction over Placebo|14.7||||||95.0|1.2|26.3|||Transf. of ANCOVA results on log data|Percent Reduction of Keppra over Placebo is calculated based on the ANCOVA on log data as 100\*(1-exp(LSmeans Keppra -LSMeans Placebo))||Treatment difference was assessed through the percent reduction in POS frequency per week of Keppra over Placebo by back transformation of the results of the ANCOVA on log data||26.3|1.2|
71047184|NCT02037165|141603641|SUPERIORITY_OR_OTHER||adjusted mean difference|1.2|STANDARD_ERROR_OF_MEAN|2.0276|||TWO_SIDED|95.0|-2.8|5.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||5.2|-2.8|
71047185|NCT02037165|141603641|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.59|STANDARD_ERROR_OF_MEAN|2.0277|||TWO_SIDED|95.0|-4.6|3.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.4|-4.6|
71047186|NCT02037165|141603641|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.88|STANDARD_ERROR_OF_MEAN|2.0278|||TWO_SIDED|95.0|-6.9|1.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.1|-6.9|
71047187|NCT02037165|141603641|SUPERIORITY_OR_OTHER||adjusted mean difference|0.43|STANDARD_ERROR_OF_MEAN|2.0279|||TWO_SIDED|95.0|-3.6|4.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.4|-3.6|
71047188|NCT02037165|141603641|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.04|STANDARD_ERROR_OF_MEAN|2.0282|||TWO_SIDED|95.0|-5.0|2.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.9|-5.0|
71047189|NCT02037165|141603642|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.94|STANDARD_ERROR_OF_MEAN|1.8566|||TWO_SIDED|95.0|-4.6|2.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.7|-4.6|
71047190|NCT02037165|141603642|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.87|STANDARD_ERROR_OF_MEAN|1.856|||TWO_SIDED|95.0|-6.5|0.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.8|-6.5|
71047191|NCT02037165|141603642|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.08|STANDARD_ERROR_OF_MEAN|1.8557|||TWO_SIDED|95.0|-6.7|0.6|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.6|-6.7|
71047192|NCT02037165|141603642|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.63|STANDARD_ERROR_OF_MEAN|1.8555|||TWO_SIDED|95.0|-5.3|2.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.0|-5.3|
71011672|NCT00368069|141530288|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.84||||0.07||95.0|0.95|3.55|||Regression, Logistic|Logistic regression analysis including Treatment as a factor.|Based on the number of evaluable patients. A patient is considered as evaluable for the response status if he has seizure information in at least one of the period (baseline or treatment period.|||3.55|0.95|0.070
71011673|NCT00368069|141530289|SUPERIORITY_OR_OTHER_LEGACY|||||||0.033||95.0|||||Mantel Haenszel|Subjects with missing data during the Treatment period were considered in the category \<-25%.||||||0.033
71011674|NCT00368069|141530290|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.205||||0.003||95.0|0.07|0.341|||ANCOVA|ANCOVA on (log-) Treatment POS frequency per week with Treatment and (log-) Baseline POS frequency per week as covariate||||0.341|0.070|0.003
71011675|NCT00368069|141530290|SUPERIORITY_OR_OTHER_LEGACY||Percent reduction over Placebo|18.6||||||95.0|6.7|28.9|||Transf. of ANCOVA results on log data|Percent Reduction of Keppra over Placebo is calculated based on the ANCOVA on log data as 100\*(1-exp(LSmeans Keppra -LSMeans Placebo))||Treatment difference was assessed through the percent reduction in POS frequency per week of Keppra over Placebo by back transformation of the results of the ANCOVA on log data||28.9|6.7|
71011676|NCT04680273|141530299|OTHER||Geometric mean ratio|0.573|STANDARD_DEVIATION|1.11|||||||||||The geometric coefficient of variation (%) for the AUC(0-72) geometric mean ratio was 10.4%. The standard deviation (SD) reported is a geometric SD.|The geometric mean ratio was calculated for the AUC(0-72) of GDC-9545 in plasma samples compared with the AUC(0-72) of total radioactivity in plasma samples.||||
71011677|NCT04680273|141530299|OTHER||Geometric mean ratio|0.752|STANDARD_DEVIATION|1.036|||||||||||The geometric coefficient of variation (%) for the AUC(0-72) geometric mean ratio was 3.5%. The standard deviation (SD) reported is a geometric SD.|The geometric mean ratio was calculated for the AUC(0-72) of total radioactivity (TR) in whole blood samples compared with the AUC(0-72) of TR in plasma samples.||||
71011678|NCT04680273|141530300|OTHER||Geometric mean ratio|0.625|STANDARD_DEVIATION|1.134|||||||||||The geometric coefficient of variation (%) for the AUC(0-t) geometric mean ratio was 12.7%. The standard deviation (SD) reported is a geometric SD.|The geometric mean ratio was calculated for the AUC(0-t) of GDC-9545 in plasma samples compared with the AUC(0-t) of total radioactivity in plasma samples.||||
71011679|NCT04680273|141530300|OTHER||Geometric mean ratio|0.79|STANDARD_DEVIATION|1.171|||||||||||The geometric coefficient of variation (%) for the AUC(0-t) geometric mean ratio was 15.9%. The standard deviation (SD) reported is a geometric SD.|The geometric mean ratio was calculated for the AUC(0-t) of total radioactivity (TR) in whole blood samples compared with the AUC(0-t) of TR in plasma samples.||||
71047193|NCT02037165|141603642|SUPERIORITY_OR_OTHER||adjusted mean difference|0.11|STANDARD_ERROR_OF_MEAN|1.8554|||TWO_SIDED|95.0|-3.5|3.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.8|-3.5|
71011680|NCT01430559|141530344|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.2|-0.43||P-value and 95% confidence interval for least squares mean difference were calculated from analysis of covariance (ANCOVA, repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||||-0.43|-1.20|<0.0001
71011681|NCT01430559|141530345|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.14||0.0103|TWO_SIDED|95.0|-0.65|-0.09||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Pain subscale (Week 2)||-0.09|-0.65|0.0103
71011682|NCT01430559|141530345|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.16||0.0295|TWO_SIDED|95.0|-0.67|-0.04||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Pain subscale (Week 4)||-0.04|-0.67|0.0295
71011683|NCT01430559|141530345|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.18||0.0041|TWO_SIDED|95.0|-0.87|-0.17||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Pain subscale (Week 8)||-0.17|-0.87|0.0041
71011684|NCT01430559|141530345|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.2|-0.43||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Pain subscale (Week 12)||-0.43|-1.20|<0.0001
71011685|NCT01430559|141530345|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.16||0.0369|TWO_SIDED|95.0|-0.64|-0.02||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Stiffness subscale (Week 2)||-0.02|-0.64|0.0369
71011686|NCT01430559|141530345|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.2642|TWO_SIDED|95.0|-0.54|0.15||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Stiffness subscale (Week 4)||0.15|-0.54|0.2642
71011687|NCT01430559|141530345|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.19||0.014|TWO_SIDED|95.0|-0.84|-0.1||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Stiffness subscale (Week 8)||-0.10|-0.84|0.0140
71011688|NCT01430559|141530345|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.2||0.0009|TWO_SIDED|95.0|-1.06|-0.28||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Stiffness subscale (Week 12)||-0.28|-1.06|0.0009
71011689|NCT01430559|141530345|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.14||0.0017|TWO_SIDED|95.0|-0.72|-0.17||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Physical function subscale (Week 2)||-0.17|-0.72|0.0017
71011690|NCT01430559|141530345|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.16||0.0328|TWO_SIDED|95.0|-0.66|-0.03||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Physical function subscale (Week 4)||-0.03|-0.66|0.0328
71011691|NCT01430559|141530345|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.18||0.0043|TWO_SIDED|95.0|-0.86|-0.16||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Physical function subscale (Week 8)||-0.16|-0.86|0.0043
71011692|NCT01430559|141530345|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.19|-0.43||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Physical function subscale (Week 12)||-0.43|-1.19|<0.0001
71011693|NCT01430559|141530345|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.13||0.0051|TWO_SIDED|95.0|-0.65|-0.12||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Average score (Week 2)||-0.12|-0.65|0.0051
71011694|NCT01430559|141530345|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.0593|TWO_SIDED|95.0|-0.61|0.01||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Average score (Week 4)||0.01|-0.61|0.0593
71011695|NCT01430559|141530345|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.0046|TWO_SIDED|95.0|-0.84|-0.16||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Average score (Week 8)||-0.16|-0.84|0.0046
71011696|NCT01430559|141530345|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.14|-0.39||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Average score (Week 12)||-0.39|-1.14|<0.0001
71011697|NCT01430559|141530346|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.16||0.0002|TWO_SIDED|95.0|-0.94|-0.3||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Walking on flat surface (Week 2)||-0.30|-0.94|0.0002
71011698|NCT01430559|141530346|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.18||0.0015|TWO_SIDED|95.0|-0.92|-0.22||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Walking on flat surface (Week 4)||-0.22|-0.92|0.0015
71011699|NCT01430559|141530346|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.19||0.0003|TWO_SIDED|95.0|-1.08|-0.32||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Walking on flat surface (Week 8)||-0.32|-1.08|0.0003
71011700|NCT01430559|141530346|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.34|-0.51||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Walking on flat surface (Week 12)||-0.51|-1.34|<0.0001
71011701|NCT01430559|141530346|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.17||0.0363|TWO_SIDED|95.0|-0.67|-0.02||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Going up or down stairs (Week 2)||-0.02|-0.67|0.0363
71077858|NCT02913105|141664397|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.01||||0.9131|TWO_SIDED|90.0|0.91|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 42||1.12|0.91|0.9131
71011702|NCT01430559|141530346|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.18||0.0311|TWO_SIDED|95.0|-0.75|-0.04||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Going up or down stairs (Week 4)||-0.04|-0.75|0.0311
71011703|NCT01430559|141530346|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.2||0.0057|TWO_SIDED|95.0|-0.94|-0.16||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Going up or down stairs (Week 8)||-0.16|-0.94|0.0057
71011704|NCT01430559|141530346|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.52|-0.64||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Going up or down stairs (Week 12)||-0.64|-1.52|<0.0001
71011705|NCT01430559|141530348|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.42||||0.2373|TWO_SIDED|95.0|0.79|2.55||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=30% reduction (Week 2)||2.55|0.79|0.2373
71011706|NCT01430559|141530348|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.38||||0.2069|TWO_SIDED|95.0|0.84|2.26||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=30% reduction (Week 4)||2.26|0.84|0.2069
71011707|NCT01430559|141530348|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.56||||0.068|TWO_SIDED|95.0|0.97|2.53||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=30% reduction (Week 8)||2.53|0.97|0.0680
70941401|NCT02567227|141383485|SUPERIORITY||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.48|0.45|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the rhythm domain during walking while talking pre and post intervention.||0.45|-0.48|
71011708|NCT01430559|141530348|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.41||||0.0005|TWO_SIDED|95.0|1.47|3.94||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=30% reduction (Week 12)||3.94|1.47|0.0005
71011709|NCT01430559|141530348|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.94||||0.1736|TWO_SIDED|95.0|0.75|5.01||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=50% reduction (Week 2)||5.01|0.75|0.1736
71011710|NCT01430559|141530348|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.72||||0.1496|TWO_SIDED|95.0|0.82|3.59||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=50% reduction (Week 4)||3.59|0.82|0.1496
71011711|NCT01430559|141530348|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.12||||0.0171|TWO_SIDED|95.0|1.14|3.93||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=50% reduction (Week 8)||3.93|1.14|0.0171
71011712|NCT01430559|141530348|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.77||||0.0004|TWO_SIDED|95.0|1.57|4.89||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=50% reduction (Week 12)||4.89|1.57|0.0004
71011713|NCT01430559|141530349|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.06||0.0027|TWO_SIDED|95.0|-0.31|-0.07||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 2||-0.07|-0.31|0.0027
71103809|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0417|STANDARD_ERROR_OF_MEAN|0.19375||0.831|TWO_SIDED|95.0|-0.4354|0.3521|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3521|-0.4354|0.831
71011714|NCT01430559|141530349|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.0308|TWO_SIDED|95.0|-0.3|-0.01||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 4||-0.01|-0.30|0.0308
71011715|NCT01430559|141530349|SUPERIORITY_OR_OTHER_LEGACY|P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|Least Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.06||0.006|TWO_SIDED|95.0|-0.31|-0.05|||ANCOVA|||Week 8||-0.05|-0.31|0.0060
71011716|NCT01430559|141530349|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.0076|TWO_SIDED|95.0|-0.34|-0.05||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 12||-0.05|-0.34|0.0076
71011717|NCT01430559|141530350|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.13||||0.2843|TWO_SIDED|95.0|0.53|8.5||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Week 2||8.50|0.53|0.2843
71011718|NCT01430559|141530350|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.05||||0.105|TWO_SIDED|95.0|0.86|4.87||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Week 4||4.87|0.86|0.1050
71011719|NCT01430559|141530350|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.7861|TWO_SIDED|95.0|0.4|3.32||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Week 8||3.32|0.40|0.7861
71011720|NCT01430559|141530350|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.71||||0.1873|TWO_SIDED|95.0|0.77|3.78||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Week 12||3.78|0.77|0.1873
71011721|NCT01430559|141530351|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.38|STANDARD_ERROR_OF_MEAN|1.55||0.3738|TWO_SIDED|95.0|-1.67|4.42||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||General health||4.42|-1.67|0.3738
71047194|NCT02037165|141603642|SUPERIORITY_OR_OTHER||adjusted mean difference|0.66|STANDARD_ERROR_OF_MEAN|1.8555|||TWO_SIDED|95.0|-3.0|4.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.3|-3.0|
71011722|NCT01430559|141530351|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|5.94|STANDARD_ERROR_OF_MEAN|1.96||0.0028|TWO_SIDED|95.0|2.07|9.8||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Physical functioning||9.80|2.07|0.0028
71011723|NCT01430559|141530351|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|8.16|STANDARD_ERROR_OF_MEAN|2.14||0.0002|TWO_SIDED|95.0|3.95|12.38||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Role physical||12.38|3.95|0.0002
71103810|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2421|STANDARD_ERROR_OF_MEAN|0.18403||0.197|TWO_SIDED|95.0|-0.6161|0.1319|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1319|-0.6161|0.197
71011724|NCT01430559|141530351|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|7.36|STANDARD_ERROR_OF_MEAN|1.66|<|0.0001|TWO_SIDED|95.0|4.1|10.63||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Bodily pain||10.63|4.10|<0.0001
71011725|NCT01430559|141530351|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|2.05|STANDARD_ERROR_OF_MEAN|1.64||0.2124|TWO_SIDED|95.0|-1.18|5.27||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Vitality||5.27|-1.18|0.2124
71011726|NCT01430559|141530351|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|5.96|STANDARD_ERROR_OF_MEAN|2.1||0.005|TWO_SIDED|95.0|1.82|10.1||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Social functioning||10.10|1.82|0.0050
71011727|NCT01430559|141530351|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|5.87|STANDARD_ERROR_OF_MEAN|2.24||0.0093|TWO_SIDED|95.0|1.46|10.28||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Role emotional||10.28|1.46|0.0093
70928696|NCT04800211|141353084|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|4.862||||0.1422|TWO_SIDED|95.0|-0.939|10.663|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||10.663|-0.939|0.1422
70941402|NCT02567227|141383485|SUPERIORITY||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.4|0.35|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the variation domain during walking while talking pre and post intervention.||0.35|-0.40|
71011728|NCT01430559|141530351|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.57|STANDARD_ERROR_OF_MEAN|1.64||0.7274|TWO_SIDED|95.0|-2.66|3.81||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Mental health||3.81|-2.66|0.7274
71011729|NCT01430559|141530351|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.94|STANDARD_ERROR_OF_MEAN|0.88||0.2819|TWO_SIDED|95.0|-0.78|2.67||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Mental component aggregate||2.67|-0.78|0.2819
71011730|NCT01430559|141530351|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|2.57|STANDARD_ERROR_OF_MEAN|0.66||0.0001|TWO_SIDED|95.0|1.27|3.86||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Physical component aggregate||3.86|1.27|0.0001
71011731|NCT01430559|141530352|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.6||||0.0014|TWO_SIDED|95.0|1.45|4.66||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Mobility||4.66|1.45|0.0014
71011732|NCT01430559|141530352|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.51||||0.108|TWO_SIDED|95.0|0.91|2.48||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Self-care||2.48|0.91|0.1080
71011733|NCT01430559|141530352|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.06||||0.0119|TWO_SIDED|95.0|1.17|3.62||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Usual activities||3.62|1.17|0.0119
71011734|NCT01430559|141530352|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.62||||0.0887|TWO_SIDED|95.0|0.93|2.83||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Pain/discomfort||2.83|0.93|0.0887
71011735|NCT01430559|141530352|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.2466|TWO_SIDED|95.0|0.8|2.33||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Anxiety/depression||2.33|0.80|0.2466
71011736|NCT01430559|141530353|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0367|TWO_SIDED|95.0|-0.58|-0.02||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 2||-0.02|-0.58|0.0367
71011737|NCT01430559|141530353|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.17||0.0652|TWO_SIDED|95.0|-0.65|0.02||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 4||0.02|-0.65|0.0652
71011738|NCT01430559|141530353|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.19||0.02|TWO_SIDED|95.0|-0.81|-0.07||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 8||-0.07|-0.81|0.0200
71011739|NCT01430559|141530353|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.2||0.0016|TWO_SIDED|95.0|-1.02|-0.24||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 12||-0.24|-1.02|0.0016
71047195|NCT02037165|141603642|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.19|STANDARD_ERROR_OF_MEAN|1.8557|||TWO_SIDED|95.0|-4.8|2.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-4.8|
71103811|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1155|STANDARD_ERROR_OF_MEAN|0.1618||0.48|TWO_SIDED|95.0|-0.4443|0.2133|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2133|-0.4443|0.480
71103812|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1673|STANDARD_ERROR_OF_MEAN|0.17458||0.345|TWO_SIDED|95.0|-0.1875|0.5221|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.5221|-0.1875|0.345
71103813|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1504|STANDARD_ERROR_OF_MEAN|0.16583||0.371|TWO_SIDED|95.0|-0.4874|0.1866|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1866|-0.4874|0.371
71103814|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1731|STANDARD_ERROR_OF_MEAN|0.18808||0.364|TWO_SIDED|95.0|-0.5553|0.2092|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2092|-0.5553|0.364
71103815|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1362|STANDARD_ERROR_OF_MEAN|0.20294||0.507|TWO_SIDED|95.0|-0.2762|0.5486|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.5486|-0.2762|0.507
71103816|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2464|STANDARD_ERROR_OF_MEAN|0.19276||0.21|TWO_SIDED|95.0|-0.6381|0.1453|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1453|-0.6381|0.210
71103817|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3059|STANDARD_ERROR_OF_MEAN|0.14253||0.039|TWO_SIDED|95.0|-0.5955|-0.0162|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||-0.0162|-0.5955|0.039
71103818|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0134|STANDARD_ERROR_OF_MEAN|0.1538||0.931|TWO_SIDED|95.0|-0.2991|0.326|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3260|-0.2991|0.931
71103819|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1164|STANDARD_ERROR_OF_MEAN|0.14608||0.431|TWO_SIDED|95.0|-0.4133|0.1804|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1804|-0.4133|0.431
71011740|NCT01177943|141530354|NON_INFERIORITY_OR_EQUIVALENCE|80-125% was used for bioequivalence (BE) criteria in terms of geometric means.|Ratio of Geometric LS Mean values|0.945|||||TWO_SIDED|90.0|0.858|1.04|||ANOVA|||||1.04|0.858|
71011741|NCT01177943|141530355|NON_INFERIORITY_OR_EQUIVALENCE|80-125% was used for bioequivalence (BE) criteria in terms of the ratio of geometric means.|Ratio of AUC(0-tlast) values|1.03|||||TWO_SIDED|90.0|1.0|1.07|||ANOVA|||||1.07|1.00|
71103820|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3269|STANDARD_ERROR_OF_MEAN|0.13362||0.02|TWO_SIDED|95.0|-0.5985|-0.0554|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||-0.0554|-0.5985|0.020
71103821|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0845|STANDARD_ERROR_OF_MEAN|0.14418||0.562|TWO_SIDED|95.0|-0.3775|0.2085|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2085|-0.3775|0.562
71011742|NCT00808665|141530356|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
71011743|NCT03319160|141530357|OTHER||Incidence per 100 patient-years|7.5|STANDARD_DEVIATION|2.74|||TWO_SIDED|95.0|6.3|8.7|||||"Poisson distribution assumed due to the infrequent nature of the events. Number of appropriate shock events: 19 (17 subjects had one appropriate shock event, one subject had two appropriate shock events).~Length of exposure: 253 patient-years."|||8.7|6.3|
71103822|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1727|STANDARD_ERROR_OF_MEAN|0.13695||0.216|TWO_SIDED|95.0|-0.451|0.1056|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1056|-0.4510|0.216
71103823|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0084|STANDARD_ERROR_OF_MEAN|0.17609||0.962|TWO_SIDED|95.0|-0.3663|0.3495|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3495|-0.3663|0.962
70928697|NCT04800211|141353084|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|5.851||||0.0334|TWO_SIDED|95.0|0.307|11.396|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||11.396|0.307|0.0334
70928698|NCT04800211|141353084|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|3.08||||0.5622|TWO_SIDED|95.0|-2.501|8.66|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||8.660|-2.501|0.5622
70928699|NCT04800211|141353084|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|4.014||||0.2841|TWO_SIDED|95.0|-1.643|9.672|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||9.672|-1.643|0.2841
70928700|NCT04800211|141353084|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|4.438||||0.0178|TWO_SIDED|95.0|0.774|8.103|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||8.103|0.774|0.0178
70941403|NCT02567227|141383486|SUPERIORITY||Odds Ratio (OR)|0.925|||||TWO_SIDED|95.0|0.369|2.319||||||Logistic model for treatment effect on substantial improvement in normal velocity adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal).||2.319|0.369|
70941404|NCT02567227|141383486|SUPERIORITY||Odds Ratio (OR)|0.961|||||TWO_SIDED|95.0|0.516|1.789||||||Logistic model for treatment effect on substantial improvement in walking while talking velocity adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal).||1.789|0.516|
71011744|NCT03319160|141530359|OTHER||Incidence per 100 patient-years|3.2|STANDARD_DEVIATION|1.78|||TWO_SIDED|95.0|1.9|4.4|||||||Poisson distribution assumed due to the infrequent nature of the events. Number of inappropriately shocked events: 8. Length of exposure: 253 patient-years.|4.4|1.9|
71011745|NCT02543918|141530374|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of the ixekizumab arm to the control arm for the tetanus vaccine was established if the lower limit of the 90% CI excludes an absolute difference of 40% or more.|Mean Difference (Final Values)|1.4|||||TWO_SIDED|90.0|-16.6|19.2||||||Tetanus vaccine responders||19.2|-16.6|
71011746|NCT02543918|141530374|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of the ixekizumab arm to the control arm for the pneumococcal vaccine was established if the lower limit of the 90% CI excludes an absolute difference of 40% or more.|Mean Difference (Final Values)|-0.8|||||TWO_SIDED|90.0|-12.9|11.0||||||Pneumococcal vaccine responders||11.0|-12.9|
71011747|NCT01731600|141530438|OTHER||Incidence rate|0.0|||||ONE_SIDED|97.5||0.067|||||The incidence of inhibitory antibodies was calculated as number of patients with inhibitors during the main phase of the trial divided by number of patients in the main phase of the trial.|A one-sided, upper 97.5% confidence limit was provided based on an exact calculation in the binomial distribution.||0.067||
71011748|NCT00465894|141530455|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||.45
71011749|NCT01362062|141530675|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 3.||||=0.001
71011750|NCT01362062|141530675|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 4.||||=0.001
71011751|NCT01362062|141530675|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 5.||||=0.001
71011752|NCT01362062|141530675|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 6.||||=0.001
71047196|NCT02037165|141603642|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.34|STANDARD_ERROR_OF_MEAN|1.856|||TWO_SIDED|95.0|-5.0|2.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.3|-5.0|
71011753|NCT01362062|141530675|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 7.||||=0.001
71011754|NCT01362062|141530675|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 8.||||=0.001
71011755|NCT01362062|141530675|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 9.||||=0.001
71011756|NCT01362062|141530675|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 10.||||=0.001
71011757|NCT01362062|141530675|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 11.||||=0.001
71011758|NCT01362062|141530675|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 12.||||=0.001
71011759|NCT01362062|141530675|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 13.||||=0.001
71011760|NCT01362062|141530676|SUPERIORITY_OR_OTHER||||||=|0.003|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 3.||||=0.003
71011761|NCT01362062|141530676|SUPERIORITY_OR_OTHER||||||=|0.005|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 4.||||=0.005
71011762|NCT01362062|141530676|SUPERIORITY_OR_OTHER||||||=|0.002|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 5.||||=0.002
71011763|NCT01362062|141530676|SUPERIORITY_OR_OTHER||||||=|0.014|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 6.||||=0.014
71011764|NCT01362062|141530676|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 7.||||=0.001
71011765|NCT01362062|141530676|SUPERIORITY_OR_OTHER||||||=|0.008|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 8.||||=0.008
71011766|NCT01362062|141530676|SUPERIORITY_OR_OTHER||||||=|0.014|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 9.||||=0.014
71011767|NCT01362062|141530676|SUPERIORITY_OR_OTHER||||||=|0.009|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 10.||||=0.009
71011768|NCT01362062|141530676|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 11.||||=0.001
71011769|NCT01362062|141530676|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 12.||||=0.001
71011770|NCT01362062|141530676|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 13.||||=0.001
71011771|NCT01362062|141530677|SUPERIORITY_OR_OTHER||||||=|0.002|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 3.||||=0.002
71011772|NCT01362062|141530677|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 4.||||=0.001
71011773|NCT01362062|141530677|SUPERIORITY_OR_OTHER||||||=|0.002|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 5.||||=0.002
71011774|NCT01362062|141530677|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 6.||||=0.001
71011775|NCT01362062|141530677|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 7.||||=0.001
71011776|NCT01362062|141530677|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 8.||||=0.001
71011777|NCT01362062|141530677|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 9.||||=0.001
71011778|NCT01362062|141530677|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 10.||||=0.001
71011779|NCT01362062|141530677|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 11.||||=0.001
71011780|NCT01362062|141530677|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 12.||||=0.001
71011781|NCT01362062|141530677|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 13.||||=0.001
71011782|NCT01362062|141530678|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 3.||||=0.001
71011783|NCT01362062|141530678|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 4.||||=0.001
71011784|NCT01362062|141530678|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 5.||||=0.001
71011785|NCT01362062|141530678|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 6.||||=0.001
71011786|NCT01362062|141530678|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 7.||||=0.001
71011787|NCT01362062|141530678|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 8.||||=0.001
71011788|NCT01362062|141530678|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 9.||||=0.001
71011789|NCT01362062|141530678|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 10.||||=0.001
71011790|NCT01362062|141530678|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 11.||||=0.001
71011791|NCT01362062|141530678|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 12.||||=0.001
71011792|NCT01362062|141530678|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 13.||||=0.001
71011793|NCT01362062|141530679|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 3.||||=0.001
71011794|NCT01362062|141530679|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 4.||||=0.001
71011795|NCT01362062|141530679|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 5.||||=0.001
71011796|NCT01362062|141530679|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 6.||||=0.001
71011797|NCT01362062|141530679|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 7.||||=0.001
71011798|NCT01362062|141530679|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 8.||||=0.001
71011799|NCT01362062|141530679|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 9.||||=0.001
71011800|NCT01362062|141530679|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 10.||||=0.001
71011801|NCT01362062|141530679|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 11.||||=0.001
71011802|NCT01362062|141530679|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 12.||||=0.001
71011803|NCT01362062|141530679|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 13.||||=0.001
71011804|NCT01362062|141530680|SUPERIORITY_OR_OTHER||||||=|0.064|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 3.||||=0.064
71011805|NCT01362062|141530680|SUPERIORITY_OR_OTHER||||||=|0.104|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 4.||||=0.104
71011806|NCT01362062|141530680|SUPERIORITY_OR_OTHER||||||=|0.052|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 5.||||=0.052
71011807|NCT01362062|141530680|SUPERIORITY_OR_OTHER||||||=|0.043|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 6.||||=0.043
71011808|NCT01362062|141530680|SUPERIORITY_OR_OTHER||||||=|0.015|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB of Visit 7.||||=0.015
71011809|NCT01362062|141530680|SUPERIORITY_OR_OTHER||||||=|0.023|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 8.||||=0.023
71011810|NCT01362062|141530680|SUPERIORITY_OR_OTHER||||||=|0.028|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 9.||||=0.028
71011811|NCT01362062|141530680|SUPERIORITY_OR_OTHER||||||=|0.048|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 10.||||=0.048
71011812|NCT01362062|141530680|SUPERIORITY_OR_OTHER||||||=|0.025|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 11.||||=0.025
71011813|NCT01362062|141530680|SUPERIORITY_OR_OTHER||||||=|0.023|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 12.||||=0.023
71011814|NCT01362062|141530680|SUPERIORITY_OR_OTHER||||||=|0.022|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 13.||||=0.022
71011815|NCT00950755|141530693|SUPERIORITY_OR_OTHER||percentage of participants|76.0|||||TWO_SIDED|95.0|62.0|89.0|||||The estimated value represents the percentage of participants with response.|||89|62|
71011816|NCT00950755|141530694|SUPERIORITY_OR_OTHER||percentage of participants|54.0|||||TWO_SIDED|95.0|38.0|69.0|||||The estimated value represents the percentage of participants with confirmed response.|||69|38|
71011817|NCT00950755|141530695|SUPERIORITY_OR_OTHER||percentage of participants|34.0|||||TWO_SIDED|95.0|20.0|49.0|||||The estimated value represents the percentage of participants with confirmed CR.|||49|20|
71011818|NCT00950755|141530696|SUPERIORITY_OR_OTHER||percentage of participants|41.0|||||TWO_SIDED|95.0|26.0|57.0|||||The estimated value represents the percentage of participants with confirmed CR + CCR.|||57|26|
71011819|NCT00950755|141530697|SUPERIORITY_OR_OTHER||percentage of participants|10.0|||||TWO_SIDED|95.0|1.0|19.0|||||The estimated value represents the percentage of participants with confirmed PR.|||19|1|
71011820|NCT02549040|141530717|OTHER||Geometric mean ratio|0.96|||||TWO_SIDED|90.0|0.85|1.09||||||Comparison of Treatment B: MK-1439 150 mg tablet (40% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.09|0.85|
71011821|NCT02549040|141530717|OTHER||Geometric mean ratio|1.13|||||TWO_SIDED|90.0|1.02|1.26||||||Comparison of Treatment C: MK-1439 150 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.26|1.02|
71011822|NCT02549040|141530717|OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.88|1.11||||||Comparison of Treatment D: MK-1439 150 mg tablet (50% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.11|0.88|
71011823|NCT02549040|141530717|OTHER||Geometric mean ratio|0.89|||||TWO_SIDED|90.0|0.8|0.99||||||Comparison of Treatment E: MK-1439 100 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.99|0.80|
71011824|NCT02549040|141530718|OTHER||Geometric mean ratio|0.88|||||TWO_SIDED|90.0|0.79|0.98||||||Comparison of Treatment B: MK-1439 150 mg tablet (40% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.98|0.79|
71011825|NCT02549040|141530718|OTHER||Geometric mean ratio|1.09|||||TWO_SIDED|90.0|0.98|1.21||||||Comparison of Treatment C: MK-1439 150 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.21|0.98|
71011826|NCT02549040|141530718|OTHER||Geometric mean ratio|0.9|||||TWO_SIDED|90.0|0.81|1.0||||||Comparison of Treatment D: MK-1439 150 mg tablet (50% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.00|0.81|
71011827|NCT02549040|141530718|OTHER||Geometric mean ratio|0.88|||||TWO_SIDED|90.0|0.79|0.97||||||Comparison of Treatment E: MK-1439 100 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.97|0.79|
71011828|NCT02549040|141530719|OTHER||Geometric mean ratio|0.7|||||TWO_SIDED|90.0|0.61|0.82||||||Comparison of Treatment B: MK-1439 150 mg tablet (40% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.82|0.61|
71011829|NCT02549040|141530719|OTHER||Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.75|1.01||||||Comparison of Treatment C: MK-1439 150 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.01|0.75|
71011830|NCT02549040|141530719|OTHER||Geometric mean ratio|0.7|||||TWO_SIDED|90.0|0.6|0.81||||||Comparison of Treatment D: MK-1439 150 mg tablet (50% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.81|0.60|
71011831|NCT02549040|141530719|OTHER||Geometric mean ratio|0.76|||||TWO_SIDED|90.0|0.66|0.86||||||Comparison of Treatment E: MK-1439 100 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.86|0.66|
71011832|NCT02549040|141530720|OTHER||Geometric mean ratio|0.82|||||TWO_SIDED|90.0|0.72|0.93||||||Comparison of Treatment B: MK-1439 150 mg tablet (40% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.93|0.72|
71011833|NCT02549040|141530720|OTHER||Geometric mean ratio|1.05|||||TWO_SIDED|90.0|0.94|1.18||||||Comparison of Treatment C: MK-1439 150 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.18|0.94|
71011834|NCT02549040|141530720|OTHER||Geometric mean ratio|0.85|||||TWO_SIDED|90.0|0.76|0.96||||||Comparison of Treatment D: MK-1439 150 mg tablet (50% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.96|0.76|
71011835|NCT02549040|141530720|OTHER||Geometric mean ratio|0.83|||||TWO_SIDED|90.0|0.74|0.94||||||Comparison of Treatment E: MK-1439 100 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.94|0.74|
71011836|NCT02549040|141530723|OTHER||Geometric mean ratio|0.84|||||TWO_SIDED|90.0|0.75|0.94||||||Comparison of Treatment B: MK-1439 150 mg tablet (40% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.94|0.75|
71011837|NCT02549040|141530723|OTHER||Geometric mean ratio|1.06|||||TWO_SIDED|90.0|0.95|1.18||||||Comparison of Treatment C: MK-1439 150 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.18|0.95|
71011838|NCT02549040|141530723|OTHER||Geometric mean ratio|0.85|||||TWO_SIDED|90.0|0.76|0.95||||||Comparison of Treatment D: MK-1439 150 mg tablet (50% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.95|0.76|
71011839|NCT02549040|141530723|OTHER||Geometric mean ratio|0.86|||||TWO_SIDED|90.0|0.77|0.96||||||Comparison of Treatment E: MK-1439 100 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.96|0.77|
71011840|NCT00329433|141530743|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||Published data show that the incidence of PF4/heparin EIA antibodies is approximately 40% (range, 20% to 60%) following cardiac surgery. We estimated that antibody formation would occur in approximately 20% of patients following thoracic surgery. Sixty patients in each group would provide 80% power to detect a decrease in the incidence of positive PF4/heparin EIA tests from 20% to 4% at an alpha level of \<0.05.||||<0.05
71077859|NCT02913105|141664397|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.9988|TWO_SIDED|90.0|0.91|1.1|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 84||1.10|0.91|0.9988
71011841|NCT00329433|141530744|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
71011842|NCT00329433|141530745|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
71011843|NCT04308668|141530752|SUPERIORITY||Mean Difference (Net)|-2.4||||0.35|TWO_SIDED|95.0|-7.0|2.2|||Fisher Exact||Values represent percentages. Experimental treatment arm compared with the placebo control arm.|||2.2|-7.0|0.35
71011844|NCT04308668|141530753|SUPERIORITY||Mean Difference (Net)|-0.27||||0.117|TWO_SIDED|95.0|-0.61|0.27|||Mixed Models Analysis|||||0.27|-0.61|0.117
71011845|NCT03808298|141530768|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.75 Hours Pre-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|1.47|||TWO_SIDED|90.0|-1.99|2.9||||||||2.90|-1.99|
71011846|NCT03808298|141530768|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.5 Hours Pre-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-2.73|2.24||||||||2.24|-2.73|
71011847|NCT03808298|141530768|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.25 Hours Pre-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|90.0|-2.25|2.79||||||||2.79|-2.25|
71011848|NCT03808298|141530768|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.5 Hours Post-dose|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|90.0|-1.94|3.09||||||||3.09|-1.94|
71011849|NCT03808298|141530768|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 1 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-2.62|2.35||||||||2.35|-2.62|
71011850|NCT03808298|141530768|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 2.5 Hours Post-dose|LS Mean|1.6|STANDARD_ERROR_OF_MEAN|1.51|||TWO_SIDED|90.0|-0.88|4.11||||||||4.11|-0.88|
71011851|NCT03808298|141530768|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 4 Hours Post-dose|LS Mean|1.1|STANDARD_ERROR_OF_MEAN|1.66|||TWO_SIDED|90.0|-1.63|3.85||||||||3.85|-1.63|
71011852|NCT03808298|141530768|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 8 Hours Post-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|1.79|||TWO_SIDED|90.0|-3.13|2.79||||||||2.79|-3.13|
71011853|NCT03808298|141530768|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 12 Hours Post-dose|LS Mean|0.9|STANDARD_ERROR_OF_MEAN|2.13|||TWO_SIDED|90.0|-2.6|4.47||||||||4.47|-2.60|
71011854|NCT03808298|141530768|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 24 Hours Post-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|90.0|-2.03|2.98||||||||2.98|-2.03|
71011855|NCT03808298|141530769|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 0.5 Hours Post-dose|LS Mean|1.2|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|90.0|-0.19|2.64||||||||2.64|-0.19|
71011856|NCT03808298|141530769|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 1 Hours Post-dose|LS Mean|1.1|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|90.0|-0.12|2.33||||||||2.33|-0.12|
71011857|NCT03808298|141530769|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 2.5 Hours Post-dose|LS Mean|2.0|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|90.0|0.4|3.67||||||||3.67|0.40|
71011858|NCT03808298|141530769|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 4 Hours Post-dose|LS Mean|2.5|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|90.0|0.6|4.49||||||||4.49|0.60|
71011859|NCT03808298|141530769|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 8 Hours Post-dose|LS Mean|2.5|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|90.0|0.09|4.94||||||||4.94|0.09|
71011860|NCT03808298|141530769|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 12 Hours Post-dose|LS Mean|1.4|STANDARD_ERROR_OF_MEAN|1.84|||TWO_SIDED|90.0|-1.62|4.47||||||||4.47|-1.62|
71011861|NCT03808298|141530769|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 24 Hours Post-dose|LS Mean|1.6|STANDARD_ERROR_OF_MEAN|1.05|||TWO_SIDED|90.0|-0.1|3.39||||||||3.39|-0.10|
70928701|NCT04800211|141353084|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.847||||0.6944|TWO_SIDED|95.0|-3.398|5.093|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||5.093|-3.398|0.6944
71011862|NCT03808298|141530770|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 0.5 Hours Post-dose|LS Mean|0.8|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|90.0|-0.6|2.2||||||||2.20|-0.60|
71011863|NCT03808298|141530770|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 1 Hours Post-dose|LS Mean|1.3|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|90.0|0.13|2.55||||||||2.55|0.13|
71011864|NCT03808298|141530770|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 2.5 Hours Post-dose|LS Mean|1.7|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|90.0|0.04|3.27||||||||3.27|0.04|
71011865|NCT03808298|141530770|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 4 Hours Post-dose|LS Mean|1.3|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-0.64|3.2||||||||3.20|-0.64|
71011866|NCT03808298|141530770|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 8 Hours Post-dose|LS Mean|2.3|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|90.0|-0.13|4.67||||||||4.67|-0.13|
71011867|NCT03808298|141530770|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 12 Hours Post-dose|LS Mean|0.7|STANDARD_ERROR_OF_MEAN|1.82|||TWO_SIDED|90.0|-2.31|3.7||||||||3.70|-2.31|
71011868|NCT03808298|141530770|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 24 Hours Post-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-1.35|2.1||||||||2.10|-1.35|
71011869|NCT03808298|141530770|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.75 Hours Pre-dose|LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|90.0|-2.94|1.89||||||||1.89|-2.94|
71047197|NCT02037165|141603642|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.84|STANDARD_ERROR_OF_MEAN|1.8566|||TWO_SIDED|95.0|-4.5|2.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.8|-4.5|
71047198|NCT02037165|141603642|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.8257|||TWO_SIDED|95.0|-4.7|2.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-4.7|
71047199|NCT02037165|141603642|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.98|STANDARD_ERROR_OF_MEAN|1.8254|||TWO_SIDED|95.0|-7.6|-0.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-0.4|-7.6|
71047200|NCT02037165|141603642|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.43|STANDARD_ERROR_OF_MEAN|1.8252|||TWO_SIDED|95.0|-6.0|1.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-6.0|
71047201|NCT02037165|141603642|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.29|STANDARD_ERROR_OF_MEAN|1.8251|||TWO_SIDED|95.0|-4.9|2.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.3|-4.9|
71047202|NCT02037165|141603642|SUPERIORITY_OR_OTHER||Slope|-1.72|STANDARD_ERROR_OF_MEAN|1.825|||TWO_SIDED|95.0|-5.3|1.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.9|-5.3|
70928702|NCT04800211|141353085|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-35.556||||0.0031|TWO_SIDED|95.0|-59.038|-12.075|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-12.075|-59.038|0.0031
70928703|NCT04800211|141353085|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-31.35||||0.0371|TWO_SIDED|95.0|-60.818|-1.882|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-1.882|-60.818|0.0371
70928704|NCT04800211|141353085|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-34.356||||0.0043|TWO_SIDED|95.0|-57.877|-10.834|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-10.834|-57.877|0.0043
70941405|NCT02567227|141383487|SUPERIORITY||Mean Difference (Net)|-7.52|STANDARD_ERROR_OF_MEAN|14.17|||TWO_SIDED|95.0|-35.45|20.41|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in Flanker performance (milliseconds) pre and post intervention.||20.41|-35.45|
71011870|NCT03808298|141530770|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.5 Hours Pre-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.48|||TWO_SIDED|90.0|-3.19|1.72||||||||1.72|-3.19|
71011871|NCT03808298|141530770|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.25 Hours Pre-dose|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|1.51|||TWO_SIDED|90.0|-2.26|2.74||||||||2.74|-2.26|
71011872|NCT03808298|141530770|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.5 Hours Post-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|1.51|||TWO_SIDED|90.0|-2.02|2.96||||||||2.96|-2.02|
71011873|NCT03808298|141530770|EQUIVALENCE|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 1 Hours Post-dose|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|1.49|||TWO_SIDED|90.0|-2.39|2.54||||||||2.54|-2.39|
71011874|NCT03808298|141530770|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 2.5 Hours Post-dose|LS Mean|1.8|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-0.67|4.28||||||||4.28|-0.67|
71011875|NCT03808298|141530770|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 4 Hours Post-dose|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|1.64|||TWO_SIDED|90.0|-2.11|3.31||||||||3.31|-2.11|
71011876|NCT03808298|141530770|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 8 Hours Post-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|1.76|||TWO_SIDED|90.0|-2.38|3.47||||||||3.47|-2.38|
71011877|NCT03808298|141530770|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 12 Hours Post-dose|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|-2.85|4.14||||||||4.14|-2.85|
71011878|NCT03808298|141530770|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 24 Hours Post-dose|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-2.36|2.6||||||||2.60|-2.36|
71011879|NCT03808298|141530771|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 0.5 Hours Post-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|90.0|-1.2|0.73||||||||0.73|-1.20|
71011880|NCT03808298|141530771|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 1 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|90.0|-1.08|0.96||||||||0.96|-1.08|
71011881|NCT03808298|141530771|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 2.5 Hours Post-dose|LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|90.0|-1.73|0.78||||||||0.78|-1.73|
71011882|NCT03808298|141530771|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 4 Hours Post-dose|LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|90.0|-1.8|0.7||||||||0.70|-1.80|
71103824|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0357|STANDARD_ERROR_OF_MEAN|0.19001||0.852|TWO_SIDED|95.0|-0.4218|0.3505|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3505|-0.4218|0.852
71011883|NCT03808298|141530771|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 8 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.05|||TWO_SIDED|90.0|-2.42|1.05||||||||1.05|-2.42|
71011884|NCT03808298|141530771|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 12 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|90.0|-2.66|1.24||||||||1.24|-2.66|
71011885|NCT03808298|141530771|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 24 Hours Post-dose|LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|90.0|-1.91|0.85||||||||0.85|-1.91|
71011886|NCT03808298|141530771|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.75 Hours Pre-dose|LS Mean|-2.2|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|-3.9|-0.48||||||||-0.48|-3.90|
71011887|NCT03808298|141530771|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.5 Hours Pre-dose|LS Mean|-1.7|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|-3.41|0.0||||||||0.00|-3.41|
71011888|NCT03808298|141530771|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.25 Hours Pre-dose|LS Mean|-1.4|STANDARD_ERROR_OF_MEAN|1.08|||TWO_SIDED|90.0|-3.21|0.36||||||||0.36|-3.21|
71011889|NCT03808298|141530771|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.5 Hours Pre-dose|LS Mean|-1.6|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|90.0|-3.25|0.01||||||||0.01|-3.25|
71011890|NCT03808298|141530771|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 1 Hours Post-dose|LS Mean|-1.7|STANDARD_ERROR_OF_MEAN|1.01|||TWO_SIDED|90.0|-3.36|-0.01||||||||-0.01|-3.36|
71011891|NCT03808298|141530771|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 2.5 Hours Post-dose|LS Mean|-1.9|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|90.0|-3.75|-0.14||||||||-0.14|-3.75|
71011892|NCT03808298|141530771|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 4 Hours Post-dose|LS Mean|-1.4|STANDARD_ERROR_OF_MEAN|1.01|||TWO_SIDED|90.0|-3.06|0.29||||||||0.29|-3.06|
71011893|NCT03808298|141530771|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 8 Hours Post-dose|LS Mean|-1.0|STANDARD_ERROR_OF_MEAN|1.24|||TWO_SIDED|90.0|-3.08|1.01||||||||1.01|-3.08|
71011894|NCT03808298|141530771|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 12 Hours Post-dose|LS Mean|-1.1|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|-3.03|0.76||||||||0.76|-3.03|
71047203|NCT02037165|141603642|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.23|STANDARD_ERROR_OF_MEAN|1.8251|||TWO_SIDED|95.0|-3.8|3.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.4|-3.8|
71079474|NCT00482170|141666448|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.712|TWO_SIDED|95.0|0.61|1.4||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.40|0.61|0.712
71011895|NCT03808298|141530771|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 24 Hours Post-dose|LS Mean|-1.0|STANDARD_ERROR_OF_MEAN|1.13|||TWO_SIDED|90.0|-2.87|0.87||||||||0.87|-2.87|
71011896|NCT03808298|141530771|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 0.5 Hours Post-dose|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|90.0|-0.89|1.07||||||||1.07|-0.89|
71011897|NCT03808298|141530771|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 1 Hours Post-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|90.0|-1.21|0.86||||||||0.86|-1.21|
71011898|NCT03808298|141530771|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 2.5 Hours Post-dose|LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.77|||TWO_SIDED|90.0|-1.71|0.83||||||||0.83|-1.71|
71011899|NCT03808298|141530771|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 4 Hours Post-dose|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|90.0|-1.07|1.46||||||||1.46|-1.07|
71011900|NCT03808298|141530771|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 8 Hours Post-dose|LS Mean|-0.8|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|90.0|-2.5|1.0||||||||1.00|-2.50|
71011901|NCT03808298|141530771|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 12 Hours Post-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|90.0|-2.22|1.74||||||||1.74|-2.22|
71011902|NCT03808298|141530771|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 24 Hours Post-dose|LS Mean|-2.2|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|90.0|-3.63|-0.85||||||||-0.85|-3.63|
71011903|NCT03808298|141530771|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.75 Hours Pre-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-2.42|1.03||||||||1.03|-2.42|
71011904|NCT03808298|141530771|OTHER|Placebo-corrected change-from-baseline Day 14 HR (bpm) at 0.5 Hours Pre-dose|LS Mean|-1.2|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-2.96|0.49||||||||0.49|-2.96|
71011905|NCT03808298|141530771|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.25 Hours Pre-dose|LS Mean|-0.8|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|90.0|-2.58|1.02||||||||1.02|-2.58|
71011906|NCT03808298|141530771|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.5 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|90.0|-2.34|0.95||||||||0.95|-2.34|
71011907|NCT03808298|141530771|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 1 Hours Post-dose|LS Mean|-1.0|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|90.0|-2.65|0.73||||||||0.73|-2.65|
71011908|NCT03808298|141530771|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 2.5 Hours Post-dose|LS Mean|-1.3|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|90.0|-3.11|0.53||||||||0.53|-3.11|
71011909|NCT03808298|141530771|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 4 Hours Post-dose|LS Mean|-1.0|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|90.0|-2.73|0.66||||||||0.66|-2.73|
71011910|NCT03808298|141530771|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 8 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|90.0|-2.77|1.37||||||||1.37|-2.77|
71011911|NCT03808298|141530771|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 12 Hours Post-dose|LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|1.15|||TWO_SIDED|90.0|-2.5|1.33||||||||1.33|-2.50|
71011912|NCT03808298|141530771|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 24 Hours Post-dose|LS Mean|-1.7|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|-3.57|0.2||||||||0.20|-3.57|
71011913|NCT03808298|141530772|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 0.5 Hours Post-dose|LS Mean|-1.2|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|90.0|-2.56|0.17||||||||0.17|-2.56|
71011914|NCT03808298|141530772|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 1 Hours Post-dose|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|90.0|-1.62|1.55||||||||1.55|-1.62|
71011915|NCT03808298|141530772|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 2.5 Hours Post-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|90.0|-1.22|2.09||||||||2.09|-1.22|
71011916|NCT03808298|141530772|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 4 Hours Post-dose|LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|90.0|-2.04|1.33||||||||1.33|-2.04|
71011917|NCT03808298|141530772|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 8 Hours Post-dose|LS Mean|1.2|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|90.0|-1.0|3.33||||||||3.33|-1.00|
71011918|NCT03808298|141530772|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 12 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|1.56|||TWO_SIDED|90.0|-2.3|2.88||||||||2.88|-2.30|
71011919|NCT03808298|141530772|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 24 Hours Post-dose|LS Mean|-1.1|STANDARD_ERROR_OF_MEAN|1.15|||TWO_SIDED|90.0|-3.0|0.81||||||||0.81|-3.00|
71011920|NCT03808298|141530772|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.75 Hours Pre-dose|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|1.64|||TWO_SIDED|90.0|-2.08|3.35||||||||3.35|-2.08|
71011921|NCT03808298|141530772|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.5 Hours Pre-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|1.69|||TWO_SIDED|90.0|-2.48|3.12||||||||3.12|-2.48|
71011922|NCT03808298|141530772|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.25 Hours Pre-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|1.69|||TWO_SIDED|90.0|-2.55|3.06||||||||3.06|-2.55|
71011923|NCT03808298|141530772|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.5 Hours Post-dose|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|90.0|-3.17|3.12||||||||3.12|-3.17|
71011924|NCT03808298|141530772|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 1 Hours Post-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|1.77|||TWO_SIDED|90.0|-2.47|3.37||||||||3.37|-2.47|
71011925|NCT03808298|141530772|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 2.5 Hours Post-dose|LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|1.74|||TWO_SIDED|90.0|-3.42|2.34||||||||2.34|-3.42|
71011926|NCT03808298|141530772|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 4 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.71|||TWO_SIDED|90.0|-3.54|2.12||||||||2.12|-3.54|
71011927|NCT03808298|141530772|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 8 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.57|||TWO_SIDED|90.0|-3.31|1.88||||||||1.88|-3.31|
71011928|NCT03808298|141530772|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 12 Hours Post-dose|LS Mean|1.4|STANDARD_ERROR_OF_MEAN|1.6|||TWO_SIDED|90.0|-1.21|4.09||||||||4.09|-1.21|
71011929|NCT03808298|141530772|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 24 Hours Post-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|1.63|||TWO_SIDED|90.0|-2.9|2.49||||||||2.49|-2.90|
71011930|NCT03808298|141530772|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 0.5 Hours Post-dose|LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|90.0|-2.0|0.77||||||||0.77|-2.00|
71011931|NCT03808298|141530772|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 1 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.97|||TWO_SIDED|90.0|-1.71|1.5||||||||1.50|-1.71|
71011932|NCT03808298|141530772|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 2.5 Hours Post-dose|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|1.02||||90.0|-1.64|1.73||||||||1.73|-1.64|
71011933|NCT03808298|141530772|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 4 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|-2.39|1.02||||||||1.02|-2.39|
71103825|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2154|STANDARD_ERROR_OF_MEAN|0.18048||0.241|TWO_SIDED|95.0|-0.5822|0.1514|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1514|-0.5822|0.241
71011934|NCT03808298|141530772|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 8 Hours Post-dose|LS Mean|0.9|STANDARD_ERROR_OF_MEAN|1.33|||TWO_SIDED|90.0|-1.26|3.13||||||||3.13|-1.26|
71011935|NCT03808298|141530772|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 12 Hours Post-dose|LS Mean|-1.3|STANDARD_ERROR_OF_MEAN|1.59||||90.0|-3.92|1.35||||||||1.35|-3.92|
71011936|NCT03808298|141530772|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 24 Hours Post-dose|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-1.96|1.89||||||||1.89|-1.96|
71011937|NCT03808298|141530772|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.75 Hours Pre-dose|LS Mean|1.4|STANDARD_ERROR_OF_MEAN|1.65|||TWO_SIDED|90.0|-1.34|4.13||||||||4.13|-1.34|
71011938|NCT03808298|141530772|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.5 Hours Pre-dose|LS Mean|1.2|STANDARD_ERROR_OF_MEAN|1.71|||TWO_SIDED|90.0|-1.61|4.05||||||||4.05|-1.61|
71011939|NCT03808298|141530772|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.25 Hours Pre-dose|LS Mean|1.5|STANDARD_ERROR_OF_MEAN|1.71|||TWO_SIDED|90.0|-1.32|4.35||||||||4.35|-1.32|
71011940|NCT03808298|141530772|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.5 Hours Post-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|1.92|||TWO_SIDED|90.0|-3.38|2.97||||||||2.97|-3.38|
71011941|NCT03808298|141530772|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 1 Hours Pre-dose|LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|1.78||||90.0|-3.48|2.42||||||||2.42|-3.48|
71011942|NCT03808298|141530772|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 2.5 Hours Post-dose|LS Mean|1.1|STANDARD_ERROR_OF_MEAN|1.76|||TWO_SIDED|90.0|-1.81|4.02||||||||4.02|-1.81|
71011943|NCT03808298|141530772|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 4 Hours Post-dose|LS Mean|1.2|STANDARD_ERROR_OF_MEAN|1.72|||TWO_SIDED|90.0|-1.67|4.04||||||||4.04|-1.67|
71011944|NCT03808298|141530772|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 8 Hours Post-dose|LS Mean|0.7|STANDARD_ERROR_OF_MEAN|1.58|||TWO_SIDED|90.0|-1.95|3.29||||||||3.29|-1.95|
71011945|NCT03808298|141530772|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 12 Hours Post-dose|LS Mean|3.3|STANDARD_ERROR_OF_MEAN|1.62|||TWO_SIDED|90.0|0.6|5.96||||||||5.96|0.60|
71011946|NCT03808298|141530772|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 24 Hours Post-dose|LS Mean|2.0|STANDARD_ERROR_OF_MEAN|1.64|||TWO_SIDED|90.0|-0.72|4.72||||||||4.72|-0.72|
71011947|NCT03808298|141530773|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 0.5 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.29|0.07||||||||0.07|-0.29|
71011948|NCT03808298|141530773|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 1 Hours Post-dose|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.02|0.34||||||||0.34|-0.02|
71011949|NCT03808298|141530773|OTHER|Placebo-corrected change-from-baseline (ms) at QRS Day 1 2.5 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.3|0.12||||||||0.12|-0.30|
71011950|NCT03808298|141530773|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 4 Hours Post-dose|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.26|0.18||||||||0.18|-0.26|
71011951|NCT03808298|141530773|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 8 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-0.57|0.38||||||||0.38|-0.57|
71011952|NCT03808298|141530773|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 12 Hours Post-dose|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|90.0|-0.65|0.56||||||||0.56|-0.65|
71047204|NCT02037165|141603642|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.46|STANDARD_ERROR_OF_MEAN|1.8252|||TWO_SIDED|95.0|-5.0|2.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.1|-5.0|
71047205|NCT02037165|141603642|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.65|STANDARD_ERROR_OF_MEAN|1.8254|||TWO_SIDED|95.0|-6.2|0.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.9|-6.2|
71047206|NCT02037165|141603642|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.31|STANDARD_ERROR_OF_MEAN|1.8257|||TWO_SIDED|95.0|-3.9|3.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.3|-3.9|
71047207|NCT02037165|141603643|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.16|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-2.8|2.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-2.8|
71047208|NCT02037165|141603643|SUPERIORITY_OR_OTHER||adjusted mean difference|2.18|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-0.5|4.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.9|-0.5|
71047209|NCT02037165|141603643|SUPERIORITY_OR_OTHER||adjusted mean difference|1.01|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-1.7|3.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.7|-1.7|
71047210|NCT02037165|141603643|SUPERIORITY_OR_OTHER||adjusted mean difference|1.26|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-1.4|3.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.9|-1.4|
71011953|NCT03808298|141530773|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 24 Hours Post-dose|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.15||||90.0|-0.11|0.4||||||||0.40|-0.11|
71011954|NCT03808298|141530773|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.75 Hours Pre-dose|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.34|0.74||||||||0.74|-0.34|
71011955|NCT03808298|141530773|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.5 Hours Pre-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.17|0.91||||||||0.91|-0.17|
71011956|NCT03808298|141530773|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.25 Hours Pre-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.04|1.05||||||||1.05|-0.04|
71011957|NCT03808298|141530773|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.5 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.26|0.82||||||||0.82|-0.26|
71011958|NCT03808298|141530773|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 1 Hours Post-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|32.0|||TWO_SIDED|90.0|-0.18|0.9||||||||0.90|-0.18|
70928705|NCT04800211|141353085|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-18.096||||0.2091|TWO_SIDED|95.0|-46.375|10.183|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||10.183|-46.375|0.2091
70928706|NCT04800211|141353085|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-24.723||||0.0197|TWO_SIDED|95.0|-45.473|-3.973|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-3.973|-45.473|0.0197
70928707|NCT04800211|141353085|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-13.595||||0.2353|TWO_SIDED|95.0|-36.08|8.891|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||8.891|-36.080|0.2353
71011959|NCT03808298|141530773|OTHER||LS Mean|0.5|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.08|1.0||||||Placebo-corrected change-from-baseline QRS (ms) at Day 14 2.5 Hours Post-dose||1.00|-0.08|
71011960|NCT03808298|141530773|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 4 Hours Post-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.19|0.94||||||||0.94|-0.19|
71011961|NCT03808298|141530773|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 8 Hours Post-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|90.0|-0.33|1.1||||||||1.10|-0.33|
71011962|NCT03808298|141530773|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 12 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|90.0|-0.5|1.06||||||||1.06|-0.50|
71011963|NCT03808298|141530773|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 24 Hours Post-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|90.0|-0.06|1.11||||||||1.11|-0.06|
71011964|NCT03808298|141530773|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 0.5 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.25|0.11||||||||0.11|-0.25|
71047211|NCT02037165|141603643|SUPERIORITY_OR_OTHER||adjusted mean difference|0.71|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-2.0|3.4|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.4|-2.0|
71011965|NCT03808298|141530773|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 1 Hours Post-dose|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|0.0|0.36||||||||0.36|0.00|
71011966|NCT03808298|141530773|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 2.5 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.34|0.09||||||||0.09|-0.34|
71011967|NCT03808298|141530773|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 4 Hours Post-dose|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.1|0.34||||||||0.34|-0.10|
71047212|NCT02037165|141603643|SUPERIORITY_OR_OTHER||adjusted mean difference|0.36|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-2.3|3.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.0|-2.3|
71079475|NCT00482170|141666448|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.733|TWO_SIDED|95.0|0.62|1.39||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.39|0.62|0.733
71011968|NCT03808298|141530773|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 8 Hours Post-dose|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-0.4|0.57||||||||0.57|-0.40|
71011969|NCT03808298|141530773|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 12 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|90.0|-0.31|0.93||||||||0.93|-0.31|
71011970|NCT03808298|141530773|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 24 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|90.0|0.07|0.58||||||||0.58|0.07|
71011971|NCT03808298|141530773|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.75 Hours Pre-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.19|0.9||||||||0.90|-0.19|
71011972|NCT03808298|141530773|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.5 Hours Pre-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.11|0.98||||||||0.98|-0.11|
71011973|NCT03808298|141530773|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.25 Hours Pre-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.06|1.05||||||||1.05|-0.06|
71011974|NCT03808298|141530773|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.5 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.27|0.82||||||||0.82|-0.27|
71011975|NCT03808298|141530773|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 1 Hours Post-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.14|0.94||||||||0.94|-0.14|
71011976|NCT03808298|141530773|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 2.5 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.24|0.86||||||||0.86|-0.24|
71011977|NCT03808298|141530773|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 4 Hours Post-dose|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|0.07|1.2||||||||1.20|0.07|
71011978|NCT03808298|141530773|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 8 Hours Post-dose|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|90.0|-0.1|1.35||||||||1.35|-0.10|
71011979|NCT03808298|141530773|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 12 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|90.0|-0.5|1.07||||||||1.07|-0.50|
71011980|NCT03808298|141530773|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 24 Hours Post-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-0.14|1.04||||||||1.04|-0.14|
71011981|NCT03808298|141530795|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 0.5 Hours Post-dose|LS Mean|1.2|STANDARD_ERROR_OF_MEAN|1.71|||TWO_SIDED|90.0|-1.64|4.04||||||||4.04|-1.64|
71011982|NCT03808298|141530795|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 1 Hours Post-dose|LS Mean|5.4|STANDARD_ERROR_OF_MEAN|1.93|||TWO_SIDED|90.0|2.22|8.63||||||||8.63|2.22|
71011983|NCT03808298|141530795|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 2.5 Hours Post-dose|LS Mean|8.5|STANDARD_ERROR_OF_MEAN|1.64|||TWO_SIDED|90.0|5.81|11.28||||||||11.28|5.81|
71011984|NCT03808298|141530795|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 4 Hours Post-dose|LS Mean|8.6|STANDARD_ERROR_OF_MEAN|1.65|||TWO_SIDED|90.0|5.86|11.34||||||||11.34|5.86|
71011985|NCT03808298|141530795|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 8 Hours Post-dose|LS Mean|8.5|STANDARD_ERROR_OF_MEAN|1.86|||TWO_SIDED|90.0|5.43|11.61||||||||11.61|5.43|
71011986|NCT03808298|141530795|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 12 Hours Post-dose|LS Mean|6.9|STANDARD_ERROR_OF_MEAN|1.88|||TWO_SIDED|90.0|3.76|10.0||||||||10.00|3.76|
71011987|NCT03808298|141530795|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 24 Hours Post-dose|LS Mean|6.1|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|90.0|3.58|8.62||||||||8.62|3.58|
71011988|NCT00953849|141530817|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|A Student's t test was performed to determine significance of differences between each of two groups.||||||<0.05
71047213|NCT02037165|141603643|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.58|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-4.3|1.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.1|-4.3|
71047214|NCT02037165|141603643|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.51|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-4.2|1.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-4.2|
71011989|NCT00953849|141530818|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|A Student's t test was performed to determine significance of differences between each of two groups.||||||<0.05
71011990|NCT00953849|141530819|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|A Student's t test was performed to determine significance of differences between each of two groups.||||||<0.05
71011991|NCT00953849|141530820|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|A Student's t test was performed to determine significance of differences between each of two groups.||||||<0.05
71011992|NCT01801475|141530821|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||The nonlinear mixed-effects modeling software program NONMEM (version VII; Icon Development Solutions, Ellicott City, MD) was used to estimate the pharmacokinetic parameters. The first-order conditional estimation (FOCE) with η-ε interaction was used for the estimation process. Volume and clearance in this model is computed as a mean of the study population (pregnant and non-pregnant women) with a log-normal distribution in the population.||||<0.05
71011993|NCT01801475|141530822|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||The nonlinear mixed-effects modeling software program NONMEM (version VII; Icon Development Solutions, Ellicott City, MD) was used to estimate the pharmacokinetic parameters. The first-order conditional estimation (FOCE) with η-ε interaction was used for the estimation process. Volume and clearance in this model is computed as a mean of the study population (pregnant and non-pregnant women) with a log-normal distribution in the population.||||<0.05
70928708|NCT04800211|141353085|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-4.759||||0.7329|TWO_SIDED|95.0|-32.159|22.641|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||22.641|-32.159|0.7329
70928709|NCT04800211|141353085|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-21.962||||0.542|TWO_SIDED|95.0|-62.989|19.065|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||19.065|-62.989|0.5420
70928710|NCT04800211|141353085|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-26.591||||0.5234|TWO_SIDED|95.0|-77.049|23.866|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||23.866|-77.049|0.5234
70928711|NCT04800211|141353085|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-20.761||||0.5975|TWO_SIDED|95.0|-61.867|20.344|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||20.344|-61.867|0.5975
70941406|NCT02567227|141383488|SUPERIORITY||Mean Difference (Net)|1.01|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-0.3|2.31|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes on the Digit Symbol Substitution Test pre and post intervention.||2.31|-0.30|
71011994|NCT00421928|141530828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.18|<|0.05||95.0|-1.04|-0.33|||ANCOVA|Analysis of covariance (ANCOVA) model was used with treatment and pooled analysis center as factors and baseline pain intensity score as a covariate.||The primary null hypothesis to be tested for the study was that the tapentadol ER group was not different from the placebo group for the primary endpoint. Assuming the mean treatment group difference of 0.7 with an SD of 2.7, 314 subjects per treatment group were estimated to provide 90% power to show that the tapentadol ER group was statistically different from placebo at an alpha level of 0.05. The total number of subjects to be randomly assigned to a treatment group for the study was 942.||-0.33|-1.04|<0.05
71011995|NCT00444028|141530840|OTHER|"The units on such analyses are generally those of slope (rise over run), with 1.000 being perfect. Although any positive slope might be considered clinically useful, a 90% CI within the criteria of 0.800-1.250 may be considered a delivery system which is as good as it gets."|Slope|0.909|||||TWO_SIDED|90.0|0.832|0.987||||||Dose proportionality by power analysis examines the linear regression of the log-AUC versus log-Dose on a by-patient basis across all doses administered. The slope and 90% confidence interval (CI) provide a clear, quantitative (best practices) assessment of the relationship of drug delivered to dose administered.||0.987|0.832|
71011996|NCT02022566|141530841|OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
71011997|NCT02022566|141530842|OTHER|Described elsewhere|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
71011998|NCT02713490|141530848|SUPERIORITY||LSMD|-26.884||||0.0381|TWO_SIDED|95.0|-56.608|2.841|||ANOVA|||||2.841|-56.608|0.0381
71011999|NCT02713490|141530849|SUPERIORITY||LSM treatment ratio|0.203||||0.0029|TWO_SIDED|95.0|0.065|0.631|||ANOVA|||||0.631|0.065|0.0029
71012000|NCT02713490|141530850|SUPERIORITY||Treatment difference|0.098||||0.0088|TWO_SIDED|95.0|0.0284|0.1685|||Cochran-Mantel-Haenszel|||||0.1685|0.0284|0.0088
71012001|NCT02713490|141530851|SUPERIORITY|||||||0.023|||||||Log Rank|||Analysis applies to the overall distribution of time to first opioid rescue, estimated from Kaplan-Meier analysis.||||0.0230
71012002|NCT02713490|141530852|SUPERIORITY|||||||0.4285|||||||Kruskal-Wallis|||||||0.4285
71012003|NCT00346775|141530855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.517|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||||0.3|-0.6|0.517
70928712|NCT04800211|141353085|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-13.337||||0.9331|TWO_SIDED|95.0|-62.853|36.179|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||36.179|-62.853|0.9331
70941407|NCT02567227|141383489|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED||||||||Estimates with standard errors are from unadjusted linear mixed effect models.|Unadjusted linear mixed effects model was used to compare performance on Trail Making Test form A pre and post intervention.||||
71047215|NCT02037165|141603643|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.83|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-3.5|1.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.8|-3.5|
71103826|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.138|STANDARD_ERROR_OF_MEAN|0.17766||0.443|TWO_SIDED|95.0|-0.4991|0.223|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2230|-0.4991|0.443
71103827|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2037|STANDARD_ERROR_OF_MEAN|0.1917||0.295|TWO_SIDED|95.0|-0.5933|0.1859|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1859|-0.5933|0.295
71047216|NCT02037165|141603643|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.64|STANDARD_ERROR_OF_MEAN|1.3254|||TWO_SIDED|95.0|-4.2|1.0|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.0|-4.2|
71047217|NCT02037165|141603643|SUPERIORITY_OR_OTHER||adjusted mean difference|1.07|STANDARD_ERROR_OF_MEAN|1.3253|||TWO_SIDED|95.0|-1.5|3.7|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.7|-1.5|
71047218|NCT02037165|141603643|SUPERIORITY_OR_OTHER||adjusted mean difference|0.82|STANDARD_ERROR_OF_MEAN|1.3253|||TWO_SIDED|95.0|-1.8|3.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.4|-1.8|
71047219|NCT02037165|141603643|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.32|STANDARD_ERROR_OF_MEAN|1.3253|||TWO_SIDED|95.0|-3.9|1.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.3|-3.9|
71047220|NCT02037165|141603643|SUPERIORITY_OR_OTHER||adjusted mean difference|0.56|STANDARD_ERROR_OF_MEAN|1.3254|||TWO_SIDED|95.0|-2.0|3.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.2|-2.0|
71103828|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0602|STANDARD_ERROR_OF_MEAN|0.18209||0.743|TWO_SIDED|95.0|-0.4303|0.3098|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3098|-0.4303|0.743
71047221|NCT02037165|141603643|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.04|STANDARD_ERROR_OF_MEAN|1.3253|||TWO_SIDED|95.0|-2.6|2.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.6|-2.6|
71047222|NCT02037165|141603643|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.05|STANDARD_ERROR_OF_MEAN|1.3253|||TWO_SIDED|95.0|-4.7|0.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.6|-4.7|
71047223|NCT02037165|141603643|SUPERIORITY_OR_OTHER||adjusted mean difference|0.4|STANDARD_ERROR_OF_MEAN|1.3253|||TWO_SIDED|95.0|-2.2|3.0|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.0|-2.2|
71047224|NCT02037165|141603643|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.26|STANDARD_ERROR_OF_MEAN|1.3254|||TWO_SIDED|95.0|-2.9|2.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.3|-2.9|
71047225|NCT02037165|141603644|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.96|STANDARD_ERROR_OF_MEAN|1.2419|||TWO_SIDED|95.0|-3.4|1.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.5|-3.4|
71047226|NCT02037165|141603644|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.97|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-4.4|0.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.5|-4.4|
71047227|NCT02037165|141603644|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.64|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-4.1|0.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.8|-4.1|
71103829|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1774|STANDARD_ERROR_OF_MEAN|0.16068||0.277||95.0|-0.504|0.1491|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1491|-0.5040|0.277
71103830|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0539|STANDARD_ERROR_OF_MEAN|0.17338||0.758|TWO_SIDED|95.0|-0.4062|0.2985|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2985|-0.4062|0.758
71103831|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4377|STANDARD_ERROR_OF_MEAN|0.16468||0.012|TWO_SIDED|95.0|-0.7724|-0.1031|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||-0.1031|-0.7724|0.012
71012004|NCT03799198|141530857|SUPERIORITY||Treatment Difference|-3.5|STANDARD_ERROR_OF_MEAN|1.02|<|0.001|TWO_SIDED|95.0|-5.51|-1.5|||ANCOVA|||Analysis of in-trial data with missing observations for body weight at month 12 imputed from the WMP arm based on a jump to reference multiple (x=100) imputation approach. Percent change in body weight from baseline to month 12 was calculated for each study participant within the FAS and analyzed using an analysis of covariance model with randomized treatment as a factor and baseline body weight (kg) as a covariate.||-1.50|-5.51|<0.001
71047228|NCT02037165|141603644|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.55|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-3.0|1.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.9|-3.0|
71012005|NCT00960869|141530873|SUPERIORITY_OR_OTHER||proportions|2.7||||0.005|TWO_SIDED|95.0|1.1|5.5|||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.|The proportion is from the PA32540 treatment group.|The primary efficacy endpoint was the proportion of subjects with gastric ulcers throughout 6 months of treatment. The primary endpoint was analyzed with the CMH test stratified by NSAID use (COX-2/Other NSAID/No) at randomization. A sample size of 250 subjects/treatment would provide 86% power to detect the difference of 8% between EC aspirin 325 mg (13%) and PA32540 (5%) with a 2-sided significance of 5%; and, provides adequate power to test the key secondary endpoints in sequential order.||5.5|1.1|0.005
71012006|NCT00960869|141530874|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects developing gastric ulcers and/or duodenal ulcers at 6 months was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||<0.001
71012007|NCT00960869|141530875|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects with Treatment Success was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||<0.001
71012008|NCT00960869|141530876|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects discontinuing from the study due to NSAID-associated upper GI adverse events was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||<0.001
71012009|NCT00960869|141530877|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO and by baseline heartburn severity at randomization.||The proportion of subjects who had no heartburn at 6 months (regardless of the presence or absence of heartburn at baseline) was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||<0.001
71012010|NCT01714726|141530880|SUPERIORITY||Risk Difference (RD)|22.5|||=|0.01|TWO_SIDED|90.0|8.3|36.8|||Regression, Logistic|||||36.8|8.3|=0.01
71012011|NCT00665366|141530937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04||||0.058|TWO_SIDED|95.0|-4.14|0.07|||ANCOVA|||||0.07|-4.14|0.058
71012012|NCT00665366|141530938|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.669|TWO_SIDED|95.0|-0.16|0.25|||ANOVA/ANCOVA||Week 3|||0.25|-0.16|0.669
71012013|NCT00665366|141530938|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.436|TWO_SIDED|95.0|-0.36|0.16|||ANOVA/ANCOVA||Week 6|||0.16|-0.36|0.436
71012014|NCT00665366|141530938|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28||||0.053|TWO_SIDED|95.0|-0.56|0.0|||ANOVA/ANCOVA||Week 9|||0.00|-0.56|0.053
71012015|NCT00665366|141530938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.044|TWO_SIDED|95.0|-0.59|-0.01|||ANOVA/ANCOVA||Week 12|||-0.01|-0.59|0.044
71012016|NCT00665366|141530939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.24|TWO_SIDED|95.0|-0.22|0.06|||ANOVA/ANCOVA model||Week 3|||0.06|-0.22|0.240
71012017|NCT00665366|141530939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.843|TWO_SIDED|95.0|-0.15|0.19|||ANOVA/ANCOVA model||Week 6|||0.19|-0.15|0.843
71012018|NCT00665366|141530939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.117|TWO_SIDED|95.0|-0.04|0.35|||ANOVA/ANCOVA model||Week 9|||0.35|-0.04|0.117
71012019|NCT00665366|141530939|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.17||||0.109|TWO_SIDED|95.0|-0.04|0.38|||ANOVA/ANCOVA model|Week 12||||0.38|-0.04|0.109
71012020|NCT00665366|141530940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.567|TWO_SIDED|95.0|-0.37|0.2|||ANOVA/ANCOVA model|Week 12||||0.20|-0.37|0.567
71012021|NCT00665366|141530941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68||||0.566|TWO_SIDED|95.0|-1.66|3.03|||ANCOVA||Total score: Week 3|||3.03|-1.66|0.566
71012022|NCT00665366|141530941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.66||||0.221||95.0|-1.0|4.32|||ANCOVA||Total score: Week 6|||4.32|-1.00|0.221
71012023|NCT00665366|141530941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.47||||0.315|TWO_SIDED|95.0|-1.4|4.35|||ANCOVA||Total score: Week 9|||4.35|-1.40|0.315
71012024|NCT00665366|141530941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.88||||0.212|TWO_SIDED|95.0|-1.08|4.84|||ANCOVA||Total score: Week 12|||4.84|-1.08|0.212
71012025|NCT00665366|141530941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.991|TWO_SIDED|95.0|-0.49|0.48|||ANCOVA||Autonomy score: Week 3|||0.48|-0.49|0.991
71012026|NCT00665366|141530941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.201|TWO_SIDED|95.0|-0.18|0.85|||ANCOVA||Autonomy score: Week 6|||0.85|-0.18|0.201
71012027|NCT00665366|141530941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.198|TWO_SIDED|95.0|-0.19|0.93|||ANCOVA||Autonomy score: Week 9|||0.93|-0.19|0.198
71012028|NCT00665366|141530941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.178|TWO_SIDED|95.0|-0.18|0.96|||ANCOVA||Autonomy score: Week 12|||0.96|-0.18|0.178
71012029|NCT00665366|141530941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.311|TWO_SIDED|95.0|-1.01|0.32|||ANCOVA||Occupational functioning score: Week 3|||0.32|-1.01|0.311
71012030|NCT00665366|141530941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.671|TWO_SIDED|95.0|-0.94|0.61|||ANCOVA||Occupational functioning score: Week 6|||0.61|-0.94|0.671
71012031|NCT00665366|141530941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.968|TWO_SIDED|95.0|-0.83|0.79|||ANCOVA||Occupational functioning score: Week 9|||0.79|-0.83|0.968
71012032|NCT00665366|141530941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.546|TWO_SIDED|95.0|-0.56|1.07|||ANCOVA||Occupational functioning score: Week 12|||1.07|-0.56|0.546
71012033|NCT00665366|141530941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.284|TWO_SIDED|95.0|-0.28|0.96|||ANCOVA||Cognitive functioning score: Week 3|||0.96|-0.28|0.284
71012034|NCT00665366|141530941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.063|TWO_SIDED|95.0|-0.04|1.35|||ANCOVA||Cognitive functioning score: Week 6|||1.35|-0.04|0.063
71047229|NCT02037165|141603644|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.29|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-2.1|2.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.7|-2.1|
71047230|NCT02037165|141603644|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.39|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-2.1|2.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.8|-2.1|
71047231|NCT02037165|141603644|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.11|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-2.3|2.6|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.6|-2.3|
71047232|NCT02037165|141603644|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.54|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-3.0|1.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.9|-3.0|
71047233|NCT02037165|141603644|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.12|STANDARD_ERROR_OF_MEAN|1.2419|||TWO_SIDED|95.0|-3.6|1.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.3|-3.6|
71047234|NCT02037165|141603644|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.29|STANDARD_ERROR_OF_MEAN|1.2344|||TWO_SIDED|95.0|-3.7|1.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.1|-3.7|
71047235|NCT02037165|141603644|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.89|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-4.3|0.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.5|-4.3|
71012035|NCT00665366|141530941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62||||0.09|TWO_SIDED|95.0|-0.1|1.34|||ANCOVA||Cognitive functioning score: Week 9|||1.34|-0.10|0.090
71012036|NCT00665366|141530941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68||||0.072|TWO_SIDED|95.0|-0.06|1.42|||ANCOVA||Cognitive functioning score: Week 12|||1.42|-0.06|0.072
71012037|NCT00665366|141530941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.499|TWO_SIDED|95.0|-0.45|0.93|||ANCOVA||Interpersonal relationships score: Week 3|||0.93|-0.45|0.499
71012038|NCT00665366|141530941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.457|TWO_SIDED|95.0|-0.48|1.06|||ANCOVA||Interpersonal relationships score: Week 6|||1.06|-0.48|0.457
71012039|NCT00665366|141530941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.525||95.0|-0.56|1.1|||ANCOVA||Interpersonal relationships score: Week 9|||1.10|-0.56|0.525
71012040|NCT00665366|141530941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.544|TWO_SIDED|95.0|-0.58|1.09|||ANCOVA||Interpersonal relationships score: Week 12|||1.09|-0.58|0.544
70928713|NCT04800211|141353085|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-19.964||||0.2444|TWO_SIDED|95.0|-53.637|13.709|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||13.709|-53.637|0.2444
70928714|NCT04800211|141353085|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-13.254||||0.5169|TWO_SIDED|95.0|-53.427|26.919|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||26.919|-53.427|0.5169
71047236|NCT02037165|141603644|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.16|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-3.6|1.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.3|-3.6|
71047237|NCT02037165|141603644|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.09|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-2.3|2.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-2.3|
71047238|NCT02037165|141603644|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.72|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-3.1|1.7|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.7|-3.1|
71047239|NCT02037165|141603644|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.42|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-2.0|2.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.8|-2.0|
71047240|NCT02037165|141603644|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.13|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-2.3|2.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.6|-2.3|
71047241|NCT02037165|141603644|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.71|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-4.1|0.7|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.7|-4.1|
71103832|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1037|STANDARD_ERROR_OF_MEAN|0.14849||0.49|TWO_SIDED|95.0|-0.4055|0.1981|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1981|-0.4055|0.490
71103833|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1007|STANDARD_ERROR_OF_MEAN|0.16023||0.534|TWO_SIDED|95.0|-0.4263|0.2249|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2249|-0.4263|0.534
71103834|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.214|STANDARD_ERROR_OF_MEAN|0.15219||0.169|TWO_SIDED|95.0|-0.5233|0.0953|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0953|-0.5233|0.169
71103835|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2641|STANDARD_ERROR_OF_MEAN|0.14118||0.07|TWO_SIDED|95.0|-0.551|0.0228|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0228|-0.5510|0.070
71103836|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0854|STANDARD_ERROR_OF_MEAN|0.15234||0.579|TWO_SIDED|95.0|-0.395|0.2242|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2242|-0.3950|0.579
71103837|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2446|STANDARD_ERROR_OF_MEAN|0.1447||0.1|TWO_SIDED|95.0|-0.5387|0.0494|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0494|-0.5387|0.100
71103838|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.13533||0.113|TWO_SIDED|95.0|-0.495|0.055|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0550|-0.4950|0.113
71012041|NCT00665366|141530941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.149|TWO_SIDED|95.0|-0.08|0.52|||ANCOVA||Leisure time score: Week 3|||0.52|-0.08|0.149
71012042|NCT00665366|141530941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.264|TWO_SIDED|95.0|-0.15|0.54|||ANCOVA||Leisure time score: Week 6|||0.54|-0.15|0.264
71012043|NCT00665366|141530941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.988|TWO_SIDED|95.0|-0.35|0.35|||ANCOVA||Leisure time score: Week 9|||0.35|-0.35|0.988
71012044|NCT00665366|141530941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.641|TWO_SIDED|95.0|-0.27|0.44|||ANCOVA||Leisure time score: Week 12|||0.44|-0.27|0.641
71012045|NCT00665366|141530941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.068|TWO_SIDED|95.0|-0.02|0.61|||ANCOVA||Financial issues score: Week 3|||0.61|-0.02|0.068
71012046|NCT00665366|141530941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.019|TWO_SIDED|95.0|0.07|0.74|||ANCOVA||Financial issues score: Week 6|||0.74|0.07|0.019
71012047|NCT00665366|141530941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.136|TWO_SIDED|95.0|-0.08|0.6|||ANCOVA||Financial issues score: Week 9|||0.60|-0.08|0.136
71012048|NCT00665366|141530941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.18||95.0|-0.11|0.57|||ANCOVA||Financial issues score: Week 12|||0.57|-0.11|0.18
71012049|NCT00665366|141530942|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.13||||0.466|TWO_SIDED|95.0|0.81|1.59|||Ration of response||Week 3|||1.59|0.81|0.466
71012050|NCT00665366|141530942|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07||||0.54|TWO_SIDED|95.0|0.86|1.32|||Risk ratio||Week 6|||1.32|0.86|0.540
71012051|NCT00665366|141530942|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.17||||0.06|TWO_SIDED|95.0|0.99|1.38|||Risk ratio||Week 9|||1.38|0.99|0.060
71012052|NCT00665366|141530942|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07||||0.289|TWO_SIDED|95.0|0.94|1.23|||Risk ratio|||||1.23|0.94|0.289
71012053|NCT00665366|141530943|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02||||0.909|TWO_SIDED|95.0|0.75|1.39|||Risk ratio (RR)||Week 3|||1.39|0.75|0.909
71012054|NCT00665366|141530943|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.06||||0.573|TWO_SIDED|95.0|0.86|1.3|||RR||Week 6|||1.30|0.86|0.573
71012055|NCT00665366|141530943|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.16||||0.08|TWO_SIDED|95.0|0.98|1.36|||RR||Week 9|||1.36|0.98|0.080
71012056|NCT00665366|141530943|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.211|TWO_SIDED|95.0|0.95|1.27|||RR||Week 12|||1.27|0.95|0.211
71012057|NCT00665366|141530944|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.68|||||TWO_SIDED|95.0|0.07|1.29|||ANOVA/ANCOVA model||Week 6|||1.29|0.07|
71012058|NCT00665366|141530944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83||||0.031|TWO_SIDED|95.0|0.08|1.58|||ANOVA/ANCOVA model||Week 12|||1.58|0.08|0.031
71012059|NCT00665366|141530944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61||||0.104|TWO_SIDED|95.0|-0.13|1.34|||ANOVA/ANCOVA model||Week 12 (LOCF)|||1.34|-0.13|0.104
71012060|NCT00665366|141530945|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|||||TWO_SIDED|95.0|-0.21|0.32|||ANCOVA||Week 3|||0.32|-0.21|
71012061|NCT00665366|141530945|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|||||TWO_SIDED|95.0|-0.05|0.53|||ANCOVA||Week 6|||0.53|-0.05|
71012062|NCT00665366|141530945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.197|TWO_SIDED|95.0|-0.11|0.54|||ANCOVA||Week 12|||0.54|-0.11|0.197
71012063|NCT00665366|141530945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.111|TWO_SIDED|95.0|-0.07|0.63|||ANCOVA||Week 12 (LOCF)|||0.63|-0.07|0.111
71012064|NCT00665366|141530946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.983|TWO_SIDED|95.0|-0.63|0.64|||ANOVA/ANCOVA model||Week 12 LOCF|||0.64|-0.63|0.983
71012065|NCT00665366|141530947|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.45|||||TWO_SIDED|95.0|0.57|3.71|||Risk Ratio|Weight gain||||3.71|0.57|
71047242|NCT02037165|141603644|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.18|STANDARD_ERROR_OF_MEAN|1.2344|||TWO_SIDED|95.0|-3.6|1.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-3.6|
71047243|NCT02037165|141603645|SUPERIORITY_OR_OTHER||adjusted mean difference|0.79|STANDARD_ERROR_OF_MEAN|1.1758|||TWO_SIDED|95.0|-1.5|3.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.1|-1.5|
71047244|NCT02037165|141603645|SUPERIORITY_OR_OTHER||adjusted mean difference|0.51|STANDARD_ERROR_OF_MEAN|1.1755|||TWO_SIDED|95.0|-1.8|2.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.8|-1.8|
71047245|NCT02037165|141603645|SUPERIORITY_OR_OTHER||adjusted mean difference|2.06|STANDARD_ERROR_OF_MEAN|0.1752|||TWO_SIDED|95.0|-0.2|4.4|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.4|-0.2|
71047246|NCT02037165|141603645|SUPERIORITY_OR_OTHER||adjusted mean difference|1.33|STANDARD_ERROR_OF_MEAN|1.1751|||TWO_SIDED|95.0|-1.0|3.6|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.6|-1.0|
71047247|NCT02037165|141603645|SUPERIORITY_OR_OTHER||adjusted mean difference|1.12|STANDARD_ERROR_OF_MEAN|1.175|||TWO_SIDED|95.0|-1.2|3.4|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.4|-1.2|
71047248|NCT02037165|141603645|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.57|STANDARD_ERROR_OF_MEAN|1.1751|||TWO_SIDED|95.0|-2.9|1.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.7|-2.9|
71047249|NCT02037165|141603645|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.43|STANDARD_ERROR_OF_MEAN|1.1752|||TWO_SIDED|95.0|-3.7|0.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.9|-3.7|
71012066|NCT00665366|141530948|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.582||95.0|||||ANCOVA|||||||0.582
71029128|NCT00453362|141565766|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35||||0.327|TWO_SIDED|95.0|0.04|3.16||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FLT Progressive Disease.|The null hypothesis is that there is no difference in OS between FLT Responders and FLT Progressive Disease. The alternative hypothesis is that FLT Responders would have prolonged OS compared with FLT Progressive Disease.||3.16|0.04|0.327
71012067|NCT01545375|141530949|SUPERIORITY|The objective was to demonstrate that VE induced by GSK2189242A vaccine (three doses in the first year of life and a booster dose in the second year of life)in preventing clinical AOM diagnosed and verified against AAP criteria was greater than 0%, as compared to the control group. One-sided p-value for the Wald-Test obtained from the general Cox proportional hazard model was calculated.|Vaccine Efficacy|3.81||||0.3016|TWO_SIDED|95.0|-11.35|16.9||The primary objective was met if the one-sided p-value calculated for the null hypothesis H0=\[clinical AOM VE ≤ 0%\] was lower than defined 1-sided alpha level: (17.8%).|Regression, Cox|||VE-AOM against AAP criteria: Occurrence of AOM during efficacy follow-up period was compared between groups to estimate Vaccine Efficacy (VE) and its 95% confidence interval using the Anderson \& Gill model (generalization of Cox proportional hazard model) taking into account for recurrent events \[Kelly, 2000\]. VE= (1 - hazard ratio) x 100 Censoring occurred at the time of the last scheduled or medically attended visit.||16.90|-11.35|0.3016
71012068|NCT00399542|141531003|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023||||||No adjustment|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||70.6% improvement in response with lubiprostone at 90% statistical power||||0.023
71012069|NCT00399542|141531004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.391|||||||van Elteren nonparametric test|Adjusted for center||||||0.391
71012070|NCT00399542|141531005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.151|||||||van Elteren nonparametric test|Adjusted for center||||||0.151
71012071|NCT00399542|141531006|SUPERIORITY_OR_OTHER_LEGACY|||||||0.163|||||||van Elteren nonparametric test|Adjusted for center||||||0.163
71012072|NCT00399542|141531007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.185|||||||van Elteren nonparametric test|Adjusted for center||||||0.185
71012073|NCT00399542|141531008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Cochran-Mantel-Haenszel|||||||0.300
71047250|NCT02037165|141603645|SUPERIORITY_OR_OTHER||adjusted mean difference|0.24|STANDARD_ERROR_OF_MEAN|1.1755|||TWO_SIDED|95.0|-2.1|2.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-2.1|
71103839|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0527|STANDARD_ERROR_OF_MEAN|0.14603||0.72|TWO_SIDED|95.0|-0.3495|0.244|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2440|-0.3495|0.720
71012074|NCT00399542|141531009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.303||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||||||0.303
71012075|NCT00399542|141531010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||||||0.047
71012076|NCT00399542|141531011|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||||||0.008
71012077|NCT00399542|141531012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.663|||||||van Elteren nonparametric test|Adjusted for center||||||0.663
71012078|NCT00399542|141531013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.224|||||||van Elteren nonparametric test|Adjusted for center||||||0.224
71012079|NCT00399542|141531014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.271|||||||van Elteren nonparametric test|Adjusted for center||||||0.271
71012080|NCT00399542|141531015|SUPERIORITY_OR_OTHER_LEGACY|||||||0.945|||||||van Elteren nonparametric test|Adjusted for center||||||0.945
71012081|NCT00399542|141531016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.352|||||||van Elteren nonparametric test|||||||0.352
71012082|NCT00399542|141531017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|||||||van Elteren nonparametric test|Adjusted for center||||||0.180
71012083|NCT00399542|141531018|SUPERIORITY_OR_OTHER_LEGACY|||||||0.275|||||||van Elteren nonparametric test|Adjusted for center||||||0.275
71012084|NCT00399542|141531019|SUPERIORITY_OR_OTHER_LEGACY|||||||0.722|||||||van Elteren nonparametric test|Adjusted for center||||||0.722
71012085|NCT00399542|141531020|SUPERIORITY_OR_OTHER_LEGACY|||||||0.177|||||||van Elteren nonparametric test|Adjusted for center||||||0.177
71012086|NCT00399542|141531021|SUPERIORITY_OR_OTHER_LEGACY|||||||0.082|||||||van Elteren nonparametric test|Adjusted for center||||||0.082
71012087|NCT00399542|141531022|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11|||||||van Elteren nonparametric test|Adjusted for center||||||0.110
71012088|NCT00399542|141531023|SUPERIORITY_OR_OTHER_LEGACY|||||||0.146|||||||van Elteren nonparametric test|Adjusted for center||||||0.146
71012089|NCT00399542|141531024|SUPERIORITY_OR_OTHER_LEGACY|||||||0.373|||||||van Elteren nonparametric test|Adjusted for center||||||0.373
71012090|NCT00399542|141531025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.339|||||||van Elteren nonparametric test|Adjusted for center||||||0.339
71012091|NCT00399542|141531026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|||||||Cochran-Mantel-Haenszel|||||||0.023
71012092|NCT00399542|141531027|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073|||||||Cochran-Mantel-Haenszel|||||||0.073
71012093|NCT00399542|141531028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062|||||||ANCOVA|Adjusted for center||||||0.062
71012094|NCT00399542|141531029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06|||||||van Elteren nonparametric test|||||||0.060
71012095|NCT00399542|141531030|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||van Elteren nonparametric test|||||||0.290
71012096|NCT00399542|141531031|SUPERIORITY_OR_OTHER_LEGACY|||||||0.495|||||||van Elteren nonparametric test|||||||0.495
71012097|NCT01830621|141531065|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.337|TWO_SIDED|95.0|0.88|1.46|||Log Rank|||||1.46|0.88|0.337
71012098|NCT01830621|141531066|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.837|TWO_SIDED|95.0|0.76|1.26|||Log Rank|||||1.26|0.76|0.837
71012099|NCT01830621|141531067|SUPERIORITY||Odds Ratio (OR)|0.98||||0.955|TWO_SIDED|95.0|0.48|2.0|||Cochran-Mantel-Haenszel|||||2.00|0.48|0.955
71012100|NCT01830621|141531069|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
71012101|NCT03301272|141531090|OTHER||Difference in differences|0.0||||0.5|TWO_SIDED|||||The threshold for statistical significance is 0.05|Regression, Linear|||||||0.5
71012102|NCT02347345|141531095|OTHER|Descriptive pilot study. Not relevant.||||||0.07|||||||Kruskal-Wallis|||||||0.07
71012103|NCT03457701|141531098|SUPERIORITY||Adjusted mean difference.|0.02||||0.9971|TWO_SIDED|95.0|-10.13|10.16|||Mixed Models Analysis||Analysis was based on a mixed effects model fitted with fixed effect terms for treatment, period, and iron isotope type and a random participant effect.|The null hypotheses is defined as the difference in fractional iron absorption between treatment arms (Daprodustat - rhEPO \[i.e., epoetin alfa or darbepoetin alfa\]) is equal to zero.||10.16|-10.13|0.9971
71012104|NCT01288911|141531112|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.34|0.57|||Log Rank||Estimated by use of Cox proportional hazards model.|PFS based on ICR Enzalutamide Vs. Bicalutamide. The (unstratified) log-rank test with an overall significance level of 0.05 (two-sided) was used to compare the PFS of enzalutamide to bicalutamide. The (unstratified) Cox proportional hazards model was used to estimate the hazard ratio of enzalutamide to bicalutamide, calculate the corresponding two-sided 95% confidence intervals and test the hypothesis that the hazard ratio is equal to 1.||0.57|0.34|<0.0001
71012105|NCT01288911|141531113|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.33|0.55|||Log Rank||Estimated by use of Cox proportional hazards model.|PFS on based investigator assessment Enzalutamide Vs. Bicalutamide.||0.55|0.33|<0.0001
71012106|NCT01288911|141531114|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Wilcoxon rank sum test|||PSA Response Enzalutamide Vs. Bicalutamide.||||<0.0001
71012107|NCT01288911|141531115|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Wilcoxon rank sum test|||Best PSA Response Enzalutamide Vs. Bicalutamide.||||<0.0001
71012108|NCT01288911|141531116|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.2|0.39|||Log Rank||Estimated by use of Cox proportional hazards model.|Time to PSA progression Enzalutamide Vs. Bicalutamide.||0.39|0.20|<0.0001
71012109|NCT01288911|141531117|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|5.07|||<|0.0001|TWO_SIDED|95.0|3.18|8.09|||Log Rank||Estimated by use of Cox proportional hazards model.|Time to PSA Enzalutamide Vs. Bicalutamide.||8.09|3.18|<0.0001
71012110|NCT01288911|141531118|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|5.55|||<|0.0001|TWO_SIDED|95.0|3.96|7.79|||Log Rank||Estimated by use of Cox proportional hazards model.|Time to ≥ 30% PSA decline from baseline Enzalutamide Vs. Bicalutamide.||7.79|3.96|<0.0001
71012111|NCT01288911|141531119|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|7.01|||<|0.0001|TWO_SIDED|95.0|4.83|10.16|||Log Rank||Estimated by use of Cox proportional hazards model.|Time to ≥ 50% PSA decline from baseline Enzalutamide Vs. Bicalutamide.||10.16|4.83|<0.0001
71012112|NCT01288911|141531120|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|13.91|||<|0.0001|TWO_SIDED|95.0|7.23|26.79|||Log Rank||Estimated by use of Cox proportional hazards model.|Time to ≥ 90% PSA decline from baseline Enzalutamide Vs. Bicalutamide.||26.79|7.23|<0.0001
71012113|NCT01288911|141531121|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51||||0.0002|TWO_SIDED|95.0|0.36|0.74|||Log Rank||Estimated by use of Cox proportional hazards model.|Radiographic PFS based on ICR Enzalutamide Vs. Bicalutamide.||0.74|0.36|0.0002
71012114|NCT00387621|141531133|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|With Bonferroni correction for multiple comparisons||||||<0.05
71012115|NCT00387621|141531134|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||rank-sum test|Rank-sum test was used due to non-normality of data with Bonferroni correction for multiple comparisons||||||<0.05
71012116|NCT02451137|141531143|SUPERIORITY||Odds Ratio (OR)|1.19||||0.0308|TWO_SIDED|95.4|1.01|1.39||Threshold for significance at 0.046 level.|Regression, Logistic|||A logistic regression model was used with treatment arm as a fixed effect and adjusted for: randomization strata of HbA1c target (\<8%,\<7%), sulfonylurea (SU) use (yes/no), glucagon like peptide1-receptor agonists (GLP-1 RA) use (yes/no) and baseline HbA1c (as continuous).||1.39|1.01|0.0308
71012117|NCT03747497|141531156|OTHER||Median Difference (Net)|-0.6|||||TWO_SIDED|95.0|-14.0|2.8||||||||2.8|-14.0|
71012118|NCT01189201|141531203|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|104.9|STANDARD_DEVIATION|7.2|||TWO_SIDED|90.0|102.07|107.8|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the geometric coefficient of variation (gCV)|No formal testing, investigation of relative bioavailability||107.80|102.07|
71012119|NCT01189201|141531204|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|104.91|STANDARD_DEVIATION|12.8|||TWO_SIDED|90.0|99.97|110.09|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||110.09|99.97|
71012120|NCT01189201|141531205|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|107.68|STANDARD_DEVIATION|15.3|||TWO_SIDED|90.0|101.7|114.02|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||114.02|101.70|
71012121|NCT01189201|141531206|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|109.68|STANDARD_DEVIATION|26.2|||TWO_SIDED|90.0|99.55|120.83|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||120.83|99.55|
71012122|NCT01189201|141531209|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|104.78|STANDARD_DEVIATION|7.1|||TWO_SIDED|90.0|102.02|107.61|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||107.61|102.02|
71012123|NCT01189201|141531210|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|104.64|STANDARD_DEVIATION|19.7|||TWO_SIDED|90.0|97.23|112.62|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||112.62|97.23|
71012124|NCT01189201|141531211|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|85.86|STANDARD_DEVIATION|9.3|||TWO_SIDED|90.0|81.33|90.64|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||90.64|81.33|
70928715|NCT04800211|141353086|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-40.174||||0.1359|TWO_SIDED|95.0|-93.12|12.772|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||12.772|-93.120|0.1359
70928716|NCT04800211|141353086|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-71.725||||0.0129|TWO_SIDED|95.0|-127.961|-15.49|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-15.490|-127.961|0.0129
70928717|NCT04800211|141353086|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-37.308||||0.3262|TWO_SIDED|95.0|-112.293|37.678|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||37.678|-112.293|0.3262
71012125|NCT01189201|141531212|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|61.41|STANDARD_DEVIATION|22.0|||TWO_SIDED|90.0|54.1|69.71|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||69.71|54.10|
71012126|NCT01189201|141531213|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|85.32|STANDARD_DEVIATION|9.4|||TWO_SIDED|90.0|80.77|90.14|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||90.14|80.77|
71012127|NCT01189201|141531214|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|93.18|STANDARD_DEVIATION|15.7|||TWO_SIDED|90.0|85.07|102.05|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||102.05|85.07|
71012128|NCT01189201|141531215|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|68.48|STANDARD_DEVIATION|27.2|||TWO_SIDED|90.0|58.59|80.03|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||80.03|58.59|
71103840|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.183|STANDARD_ERROR_OF_MEAN|0.1387||0.196|TWO_SIDED|95.0|-0.4649|0.0989|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0989|-0.4649|0.196
70941408|NCT02567227|141383490|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.07|0.06|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in performance on Trail Making Test form B pre and post intervention.||0.06|-0.07|
71103841|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2051|STANDARD_ERROR_OF_MEAN|0.20032||0.313|TWO_SIDED|95.0|-0.6122|0.202|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2020|-0.6122|0.313
71103842|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0253|STANDARD_ERROR_OF_MEAN|0.21616||0.908|TWO_SIDED|95.0|-0.414|0.4646|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.4646|-0.4140|0.908
71103843|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3042|STANDARD_ERROR_OF_MEAN|0.20531||0.148|TWO_SIDED|95.0|-0.7214|0.1131|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1131|-0.7214|0.148
71103844|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3409|STANDARD_ERROR_OF_MEAN|0.17997||0.067|TWO_SIDED|95.0|-0.7066|0.0249|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0249|-0.7066|0.067
71103845|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0652|STANDARD_ERROR_OF_MEAN|0.19419||0.739|TWO_SIDED|95.0|-0.4599|0.3294|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3294|-0.4599|0.739
71103846|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4163|STANDARD_ERROR_OF_MEAN|0.18445||0.031|TWO_SIDED|95.0|-0.7912|-0.0415|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||-0.0415|-0.7912|0.031
71103847|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2032|STANDARD_ERROR_OF_MEAN|0.14369||0.166|TWO_SIDED|95.0|-0.4952|0.0888|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0888|-0.4952|0.166
71103848|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0932|STANDARD_ERROR_OF_MEAN|0.15504||0.552|TWO_SIDED|95.0|-0.2219|0.4083|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.4083|-0.2219|0.552
71103849|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1648|STANDARD_ERROR_OF_MEAN|0.14727||0.271|TWO_SIDED|95.0|-0.4641|0.1345|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1345|-0.4641|0.271
71103850|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2516|STANDARD_ERROR_OF_MEAN|0.16169||0.129|TWO_SIDED|95.0|-0.5802|0.077|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0770|-0.5802|0.129
71012129|NCT01189201|141531216|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|90.95|STANDARD_DEVIATION|13.2|||TWO_SIDED|90.0|84.24|98.19|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||98.19|84.24|
71103851|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1279|STANDARD_ERROR_OF_MEAN|0.17447||0.468|TWO_SIDED|95.0|-0.2266|0.4825|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.4825|-0.2266|0.468
71103852|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2033|STANDARD_ERROR_OF_MEAN|0.16572||0.228|TWO_SIDED|95.0|-0.5401|0.1334|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1334|-0.5401|0.228
71012130|NCT01189201|141531217|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|95.64|STANDARD_DEVIATION|9.6|||TWO_SIDED|90.0|91.19|100.3|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||100.30|91.19|
71012131|NCT01189201|141531218|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|98.04|STANDARD_DEVIATION|13.0|||TWO_SIDED|90.0|91.95|104.53|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||104.53|91.95|
71012132|NCT01189201|141531219|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|95.69|STANDARD_DEVIATION|9.8|||TWO_SIDED|90.0|91.17|100.43|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||100.43|91.17|
71012133|NCT01189201|141531220|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|92.98|STANDARD_DEVIATION|14.9|||TWO_SIDED|90.0|86.36|100.09|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||100.09|86.36|
71012134|NCT01189201|141531221|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|103.71|STANDARD_DEVIATION|22.4|||TWO_SIDED|90.0|92.93|115.74|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||115.74|92.93|
71012135|NCT01189201|141531222|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|96.36|STANDARD_DEVIATION|14.3|||TWO_SIDED|90.0|89.78|103.42|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||103.42|89.78|
71012136|NCT01266967|141531224|SUPERIORITY_OR_OTHER||percentage of participants|41.0|||<|0.0001|TWO_SIDED|95.0|29.3|52.6|||Exact Test||The estimated value represents the percentage of participants with OIR.|||52.6|29.3|<0.0001
71012137|NCT01266967|141531224|SUPERIORITY_OR_OTHER||percentage of participants|37.0|||<|0.0001|TWO_SIDED|95.0|25.3|49.8|||Exact Test||The estimated value represents the percentage of participants with OIR.|||49.8|25.3|<0.0001
71012138|NCT03159455|141531259|OTHER||Slope|2.2305|STANDARD_ERROR_OF_MEAN|0.2592|||TWO_SIDED|95.0|1.6955|2.7655|||||Dose proportionality was explored using the power model.The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose). Dose proportionality of tablets for AUC0-24 was analysed in Japanese subjects.|Standard error of mean is standard error of slope.|2.7655|1.6955|
71012139|NCT03159455|141531260|OTHER||Slope|1.9007|STANDARD_ERROR_OF_MEAN|0.2382|||TWO_SIDED|95.0|1.4102|2.3912|||||Dose proportionality was explored using the power model.The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose). Dose proportionality of tablets for Cmax was analysed in Japanese subjects.|Standard error of mean is standard error of slope.|2.3912|1.4102|
71103853|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13268||0.141|TWO_SIDED|95.0|-0.4696|0.0696|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0696|-0.4696|0.141
71012140|NCT03159455|141531261|OTHER||Slope|3.244|STANDARD_ERROR_OF_MEAN|0.1771|||TWO_SIDED|95.0|2.8793|3.6087|||||Dose proportionality was explored using the power model.The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing on Day 28 (after multiple doses). Dose proportionality of tablets for AUC0-24,28 was analysed in Japanese subjects.|Standard error of mean is standard error of slope.|3.6087|2.8793|
71012141|NCT03159455|141531262|OTHER||Slope|2.0711|STANDARD_ERROR_OF_MEAN|0.148|||TWO_SIDED|95.0|1.7663|2.376|||||Dose proportionality was explored using the power model.The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing on Day 28 (after multiple doses). Dose proportionality of tablets for Cmax,28 was analysed in Japanese subjects.|Standard error of mean is standard error of slope.|2.3760|1.7663|
71012142|NCT05040295|141531264|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Ratio of adjust geometric means|102.5|||||TWO_SIDED|90.0|94.21|111.51|||||Reference = Treatment A Test = Treatment B Ratio=Test/Reference|AUCinf was analyzed using a mixed effects model with sequence and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||111.51|94.21|
71047251|NCT02037165|141603645|SUPERIORITY_OR_OTHER||adjusted mean difference|0.43|STANDARD_ERROR_OF_MEAN|1.1758|||TWO_SIDED|95.0|-1.9|2.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.7|-1.9|
71103854|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0065|STANDARD_ERROR_OF_MEAN|0.14317||0.964|TWO_SIDED|95.0|-0.2975|0.2844|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2844|-0.2975|0.964
70941409|NCT02567227|141383491|SUPERIORITY||Mean Difference (Net)|0.67|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|95.0|-0.86|2.2|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes performance on the Controlled Oral Word Association Test pre and post intervention.||2.20|-0.86|
71012143|NCT05040295|141531264|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Ratio of adjust geometric means|106.65|||||TWO_SIDED|90.0|100.07|113.66|||||Reference = Treatment A Test = Treatment C Ratio=Test/Reference|AUCinf was analyzed using a mixed effects model with sequence and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||113.66|100.07|
71012144|NCT05040295|141531265|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Ratio of adjust geometric means|101.12|||||TWO_SIDED|90.0|88.25|115.87|||||Reference = Treatment A Test = Treatment B Ratio=Test/Reference|Cmax was analyzed using a mixed effects model with sequence and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||115.87|88.25|
71012145|NCT05040295|141531265|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Ratio of adjust geometric means|90.11|||||TWO_SIDED|90.0|78.49|103.44|||||Reference = Treatment A Test = Treatment C Ratio=Test/Reference|Cmax was analyzed using a mixed effects model with sequence and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||103.44|78.49|
71012146|NCT02748096|141531272|OTHER||||||<|0.05||||||A p value of less than 0.05 was considered statistically significant for all the radiographic parameters .|t-test, 2 sided|This test applies to comparison between the two treatment arms and assesses all the radiographic parameters||The sample size was calculated from a previous study that used similar radiological assessments to compare OUKAs performed using conventional instrumentation and computer navigation. In this study, the standard deviation of the tibia varus/valgus angle for the control group was 3.6°. Assuming a minimum clinically important difference of 3°, the SMD would be 0.8. Hence with a power of 0.8 and significance level of 0.05, a total sample size of 44 patients (22 in each group) was required.||||<0.05
71012147|NCT02748096|141531273|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71012148|NCT02748096|141531274|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71012149|NCT01153971|141531279|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71012150|NCT03410693|141531297|SUPERIORITY||ORR difference (R-C)|-2.1|||=|0.6991|TWO_SIDED|95.0|-14.0|9.9|||Fisher Exact|||||9.9|-14.0|=0.6991
71012151|NCT03410693|141531297|SUPERIORITY||ORR difference (R - C)|-4.5|||=|0.7944|TWO_SIDED|95.0|-18.9|9.9|||Fisher Exact|||||9.9|-18.9|=0.7944
71012152|NCT03410693|141531298|SUPERIORITY||DCR difference (R-C)|-5.1|||=|0.7962|TWO_SIDED|95.0|-19.9|9.7|||Fisher Exact|||||9.7|-19.9|=0.7962
71012153|NCT03410693|141531298|SUPERIORITY||DCR difference (R-C)|-10.3|||=|0.9109|TWO_SIDED|95.0|-27.5|6.9|||Fisher Exact|||||6.9|-27.5|=0.9109
71103855|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1935|STANDARD_ERROR_OF_MEAN|0.13599||0.164|TWO_SIDED|95.0|-0.4699|0.0828|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0828|-0.4699|0.164
71012154|NCT03410693|141531299|SUPERIORITY||Hazard Ratio (HR)|1.226|||=|0.8672|TWO_SIDED|95.0|0.853|1.762|||Log Rank|||||1.762|0.853|= 0.8672
71012155|NCT03410693|141531299|SUPERIORITY||Hazard Ratio (HR)|1.341||||0.9171|TWO_SIDED|95.0|0.88|2.043|||Log Rank|||||2.043|0.880|0.9171
71012156|NCT03628781|141531575|SUPERIORITY||Odds Ratio (OR)|0.384||||0.535|TWO_SIDED||||||Chi-squared|||||||.535
71012157|NCT03628781|141531576|SUPERIORITY||Slope|0.018|STANDARD_ERROR_OF_MEAN|0.081||0.829|TWO_SIDED||||||ANOVA|||||||.829
71012158|NCT03628781|141531577|SUPERIORITY||Slope|-0.105|STANDARD_ERROR_OF_MEAN|0.093||0.357|TWO_SIDED||||||ANOVA|||||||.357
71012159|NCT03628781|141531578|SUPERIORITY||Slope|-0.035|STANDARD_ERROR_OF_MEAN|0.126||0.782|TWO_SIDED||||||ANOVA|||||||.782
71012160|NCT00656669|141531579|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||t-test, 2 sided|This is a paired t-test to compare baseline IFP to IFP after completion of sunitinib monotherapy||From Taghian et al., we used a mean IFP of 6.5 at baseline and a standard deviation of 6.1. We would like to detect a 50% reduction of IFP (to 3.25 mmHg) with sunitinib monotherapy, so the effect size would be 3.25/6.1=0.53. A two-sided paired t-test has 80% power to detect an effect size of .53 and level of significance .05 when the sample size is 30 patients.||||0.0001
71012161|NCT00656669|141531580|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7963||||||a priori threshold of \<0.05|t-test, 2 sided|This is a paired t-test to compare baseline IFP to IFP after completion of paxlitaxel+sunitinib treatment||||||0.7963
71029129|NCT04885296|141565768|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the mean difference (Test - Control) was greater than -5. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for population of soft disposable contact lens wearers.|LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|95.0|-2.2|3.0|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test - Control|||3.0|-2.2|
71103856|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1446|STANDARD_ERROR_OF_MEAN|0.13315||0.285|TWO_SIDED|95.0|-0.4152|0.126|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1260|-0.4152|0.285
71012162|NCT03778021|141531583|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.093||0.017|TWO_SIDED|95.0|0.04|0.41||"Estimated differential change in score between intervention and comparison group from repeated measures linear mixed model.~All the reported analyses conservatively specified covariance structure as general covariance (unstructured). alpha = 0.05."|Mixed Models Analysis|Repeated measures linear mixed model analysis. Student nested within school. Model fit time, intervention and time by intervention interaction.|Estimated differential change (intervention minus control) from repeated measures linear mixed model|"The unit of measure is score on a scale. The results show the least squares estimate of change in that score, from baseline to 8-month follow-up in each group from model.~Values from the 100 and 194 baseline respondents and from the 72 and 141 follow-up respondents of intervention and comparison groups respectively contributed to the repeated measures linear mixed model, where the units of analysis were participant-time. The nesting within schools was accounted for in the model."|"In the repeated measures linear mixed model, time was treated as a fixed effect. In the specification of the repeated measures linear mixed model, students were nested within schools.~All the reported analyses conservatively specified covariance structure as general covariance (unstructured)."|0.41|0.04|0.017
71012163|NCT03778021|141531584|SUPERIORITY||Mean Difference (Net)|1.41||||0.18|TWO_SIDED|95.0|-0.66|3.49||"Estimated differential change in score between intervention and comparison group from repeated measures linear mixed model.~All the reported analyses conservatively specified covariance structure as general covariance (unstructured). alpha = 0.05"|Mixed Models Analysis|Repeated measures linear mixed model analysis. Student nested within school. Model fit time, intervention and time by intervention interaction.|Estimated differential change from baseline to follow-up from model (intervention minus control)|"Results present estimated change in score from baseline to 8-month follow-up in each group from model.~Values from the 100 and 194 baseline respondents and from the 72 and 141 follow-up respondents of intervention and comparison groups respectively contributed to the repeated measures linear mixed model, where the units of analysis were participant-time. The nesting within schools was accounted for in the model."|In the repeated measures linear mixed model, time was treated as a fixed effect. In the specification of the repeated measures linear mixed model, students were nested within schools|3.49|-0.66|0.18
71012164|NCT03778021|141531585|SUPERIORITY||Odds Ratio (OR)|1.29||||0.51|TWO_SIDED|95.0|0.6|2.81||"Repeated measures generalized linear mixed model with binomial distribution (variable was I know I can - yes versus no)."|Mixed Models Analysis|The odds of the odds ratio is reported as the intervention effect.|Odds ratio from estimated least squares from generalized mixed model with binomial distribution specified. Intervention odds of change compared to comparison group odds of change via odds ratio..|"Odds ratio of 8-month follow-up to baseline percent reporting  I know I can was estimated from repeated measures generalized linear mixed model with binomial distribution.~Values included from the 100 and 194 baseline respondents and from the 72 and 141 8-month follow-up respondents of intervention and comparison groups respectively. The person-timepoint is the unit of analysis."||2.81|0.60|0.51
71012165|NCT02687815|141531601|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.63|TWO_SIDED|95.0|0.69|1.85|||Regression, Cox|||||1.85|0.69|0.63
71012166|NCT02687815|141531602|SUPERIORITY||Hazard Ratio (HR)|1.32||||0.46|TWO_SIDED|95.0|0.63|2.75|||Regression, Cox|||||2.75|0.63|0.46
71012167|NCT02687815|141531603|SUPERIORITY||Odds Ratio (OR)|0.99||||0.99|TWO_SIDED|95.0|0.66|1.52|||Regression, Logistic|||||1.52|0.66|0.99
71047252|NCT02037165|141603645|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.68|STANDARD_ERROR_OF_MEAN|1.1567|||TWO_SIDED|95.0|-4.0|0.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.6|-4.0|
71047253|NCT02037165|141603645|SUPERIORITY_OR_OTHER||adjusted mean difference|0.52|STANDARD_ERROR_OF_MEAN|1.1566|||TWO_SIDED|95.0|-1.8|2.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.8|-1.8|
71047254|NCT02037165|141603645|SUPERIORITY_OR_OTHER||adjusted mean difference|1.89|STANDARD_ERROR_OF_MEAN|1.1565|||TWO_SIDED|95.0|-0.4|4.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.2|-0.4|
71047255|NCT02037165|141603645|SUPERIORITY_OR_OTHER||adjusted mean difference|1.25|STANDARD_ERROR_OF_MEAN|1.1564|||TWO_SIDED|95.0|-1.0|3.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.5|-1.0|
71103857|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0176|STANDARD_ERROR_OF_MEAN|0.14368||0.903|TWO_SIDED|95.0|-0.3096|0.2744|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2744|-0.3096|0.903
71012168|NCT02687815|141531604|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.049|TWO_SIDED|95.0|0.001|8.8|||Regression, Linear|||||8.80|0.001|0.049
71012169|NCT02558634|141531605|SUPERIORITY||Median Difference (Final Values)|1.25||||0.025|TWO_SIDED|95.0|0.75|1.75||The level of significance was set at p=0.025 to allow a Bonferroni correction for these two tests (i.e. p=0.050 divided by two).|Wilcoxon (Mann-Whitney)|||||1.75|0.75|0.025
71012170|NCT06045026|141531663|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
71012171|NCT06045026|141531663|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
71012172|NCT06045026|141531663|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
71012173|NCT06045026|141531663|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
71012174|NCT06045026|141531663|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
71012175|NCT06045026|141531663|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
71012176|NCT06045026|141531664|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
71012177|NCT06045026|141531664|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
71012178|NCT06045026|141531664|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
71012179|NCT06045026|141531664|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
71012180|NCT06045026|141531664|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
71012181|NCT06045026|141531664|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
71012182|NCT06045026|141531665|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
71012183|NCT06045026|141531665|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
71012184|NCT06045026|141531665|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
71012185|NCT06045026|141531665|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
71012186|NCT06045026|141531665|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
71012187|NCT06045026|141531665|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
71012188|NCT06045026|141531666|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
71012189|NCT06045026|141531666|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
71012190|NCT06045026|141531666|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
71012191|NCT06045026|141531666|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
71012192|NCT06045026|141531666|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
71012193|NCT06045026|141531666|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
71012194|NCT06045026|141531667|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
71012195|NCT06045026|141531667|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
71012196|NCT06045026|141531667|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
71012197|NCT06045026|141531667|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
71012198|NCT06045026|141531667|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
71012199|NCT06045026|141531667|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
71012200|NCT06045026|141531668|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
71012201|NCT06045026|141531668|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
71012202|NCT06045026|141531668|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
71012203|NCT06045026|141531668|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
71012204|NCT06045026|141531668|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
71012205|NCT06045026|141531668|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
71012206|NCT06045026|141531669|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q1 (How intense are the sensations?): Change from Baseline at Week 4||||<0.0001
71012207|NCT06045026|141531669|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q1 (How intense are the sensations?): Change from Baseline at Week 8||||<0.0001
71012208|NCT06045026|141531669|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q1 (How intense are the sensations?): Change from Baseline at Week 12||||<0.0001
71012209|NCT06045026|141531669|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q1 (How intense are the sensations?): Change from Baseline at Week 16||||<0.0001
70928718|NCT04800211|141353086|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-20.012||||0.4343|TWO_SIDED|95.0|-70.468|30.444|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||30.444|-70.468|0.4343
71012210|NCT06045026|141531669|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q1 (How intense are the sensations?): Change from Baseline at Week 20||||<0.0001
71012211|NCT06045026|141531669|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q1 (How intense are the sensations?): Change from Baseline at Week 24||||<0.0001
71012212|NCT06045026|141531669|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q2 (How bothered are you by any sensations?): Change from Baseline at Week 4||||<0.0001
71012213|NCT06045026|141531669|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q2 (How bothered are you by any sensations?): Change from Baseline at Week 8||||<0.0001
71012214|NCT06045026|141531669|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q2 (How bothered are you by any sensations?): Change from Baseline at Week 12||||<0.0001
71012215|NCT06045026|141531669|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q2 (How bothered are you by any sensations?): Change from Baseline at Week 16||||<0.0001
71012216|NCT06045026|141531669|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q2 (How bothered are you by any sensations?): Change from Baseline at Week 20||||<0.0001
71012217|NCT06045026|141531669|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q2 (How bothered are you by any sensations?): Change from Baseline at Week 24||||<0.0001
71012218|NCT06045026|141531669|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q3 (How well can you tolerate sensations?): Change from Baseline at Week 4||||<0.0001
71012219|NCT06045026|141531669|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q3 (How well can you tolerate sensations?): Change from Baseline at Week 8||||<0.0001
71012220|NCT06045026|141531669|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q3 (How well can you tolerate sensations?): Change from Baseline at Week 12||||<0.0001
71012221|NCT06045026|141531669|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q3 (How well can you tolerate sensations?): Change from Baseline at Week 16||||<0.0001
71012222|NCT06045026|141531669|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q3 (How well can you tolerate sensations?): Change from Baseline at Week 20||||<0.0001
71012223|NCT06045026|141531669|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q3 (How well can you tolerate sensations?): Change from Baseline at Week 24||||<0.0001
71012224|NCT06045026|141531670|SUPERIORITY|||||||0.01|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||0.0100
71012225|NCT06045026|141531670|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
71047256|NCT02037165|141603645|SUPERIORITY_OR_OTHER||adjusted mean difference|0.67|STANDARD_ERROR_OF_MEAN|1.1564|||TWO_SIDED|95.0|-1.6|2.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.9|-1.6|
71012226|NCT06045026|141531670|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
71012227|NCT06045026|141531670|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
71012228|NCT06045026|141531670|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
71012229|NCT06045026|141531670|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
71012230|NCT06045026|141531671|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
71012231|NCT06045026|141531671|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
71012232|NCT06045026|141531671|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
71012233|NCT06045026|141531671|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
71012234|NCT06045026|141531671|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
71012235|NCT06045026|141531671|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
71012236|NCT06045026|141531673|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 1||||<0.0001
71012237|NCT06045026|141531673|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 2||||<0.0001
71012238|NCT06045026|141531673|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
71012239|NCT06045026|141531673|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
71047257|NCT02037165|141603645|SUPERIORITY_OR_OTHER||adjusted mean difference of 200 mg BI mi|-0.43|STANDARD_ERROR_OF_MEAN|1.1564|||TWO_SIDED|95.0|-2.7|1.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.8|-2.7|
71012240|NCT06045026|141531673|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
71012241|NCT06045026|141531673|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
71047258|NCT02037165|141603645|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.76|STANDARD_ERROR_OF_MEAN|1.1565|||TWO_SIDED|95.0|-3.0|1.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.5|-3.0|
71047259|NCT02037165|141603645|SUPERIORITY_OR_OTHER||adjusted mean difference|0.09|STANDARD_ERROR_OF_MEAN|1.1566|||TWO_SIDED|95.0|-2.2|2.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.4|-2.2|
71047260|NCT02037165|141603645|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.71|STANDARD_ERROR_OF_MEAN|1.1567|||TWO_SIDED|95.0|-3.0|1.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.6|-3.0|
71047261|NCT02037165|141603646|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.53|STANDARD_ERROR_OF_MEAN|1.1242|||TWO_SIDED|95.0|-2.7|1.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.7|-2.7|
71103858|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1615|STANDARD_ERROR_OF_MEAN|0.13647||0.245|TWO_SIDED|95.0|-0.4388|0.1159|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1159|-0.4388|0.245
71012242|NCT06045026|141531673|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
71012243|NCT06045026|141531673|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
71012244|NCT00920582|141531676|SUPERIORITY||Odds Ratio (OR)|1.348||||0.609|TWO_SIDED|95.0|0.431|4.219|||Mantel Haenszel|||||4.219|0.431|0.609
71012245|NCT00920582|141531676|SUPERIORITY||Odds Ratio (OR)|1.356||||0.601|TWO_SIDED|95.0|0.453|4.23|||Mantel Haenszel|||||4.230|0.453|0.601
71012246|NCT00920582|141531676|SUPERIORITY||Odds Ratio (OR)|1.624||||0.4|TWO_SIDED|95.0|0.521|5.066|||Mantel Haenszel|||||5.066|0.521|0.400
71012247|NCT00920582|141531678|SUPERIORITY||Mean Difference (Final Values)|-0.028||||0.365|TWO_SIDED|95.0|-0.086|0.031|||ANCOVA|||||0.031|-0.086|0.365
71012248|NCT00920582|141531678|SUPERIORITY||Mean Difference (Final Values)|-0.007||||0.842|TWO_SIDED|95.0|-0.078|0.064|||ANCOVA|||||0.064|-0.078|0.842
71012249|NCT00920582|141531678|SUPERIORITY||Mean Difference (Final Values)|0.021||||0.565|TWO_SIDED|95.0|-0.089|0.171|||ANCOVA|||||0.171|-0.089|0.565
71012250|NCT00920582|141531683|SUPERIORITY||Odds Ratio (OR)|2.197||||0.142|TWO_SIDED|95.0|0.764|6.312|||Mantel Haenszel|||||6.312|0.764|0.142
71012251|NCT00920582|141531683|SUPERIORITY||Odds Ratio (OR)|1.487||||0.46|TWO_SIDED|95.0|0.517|4.278|||Mantel Haenszel|||||4.278|0.517|0.460
71012252|NCT00920582|141531683|SUPERIORITY||Odds Ratio (OR)|1.954||||0.199|TWO_SIDED|95.0|0.69|5.532|||Mantel Haenszel|||||5.532|0.690|0.199
71012253|NCT00796367|141531721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.71|STANDARD_ERROR_OF_MEAN|0.673|<|0.0001|TWO_SIDED|95.0|7.39|10.03||Intersection-union method applied in a step-down testing approach|ANCOVA|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)||10.03|7.39|<0.0001
71012254|NCT00796367|141531721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.52|STANDARD_ERROR_OF_MEAN|0.799|<|0.0001|TWO_SIDED|95.0|5.95|9.09||Intersection-union method applied in a step-down testing approach|ANCOVA|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)||9.09|5.95|<0.0001
71012255|NCT00796367|141531721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.19|STANDARD_ERROR_OF_MEAN|0.76||0.1189|TWO_SIDED|95.0|-0.31|2.68||Intersection-union method applied in a step-down testing approach|ANCOVA|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)||2.68|-0.31|0.1189
71012256|NCT00796367|141531722|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.4|STANDARD_ERROR_OF_MEAN|1.97|<|0.0001|TWO_SIDED|95.0|6.24|14.16||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)||14.16|6.24|<0.0001
71012257|NCT00796367|141531722|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.99|STANDARD_ERROR_OF_MEAN|1.68|<|0.0001|TWO_SIDED|95.0|4.36|11.19||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)||11.19|4.36|<0.0001
71012258|NCT00796367|141531722|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35|STANDARD_ERROR_OF_MEAN|0.32||0.2169|TWO_SIDED|95.0|0.84|2.15|||Regression, Logistic|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)||2.15|0.84|0.2169
71012259|NCT05664672|141531723|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|24.2|||<|0.0001|TWO_SIDED|95.0|15.9|37.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||37.0|15.9|<.0001
71012260|NCT05664672|141531723|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|25.3|||<|0.0001|TWO_SIDED|95.0|17.1|37.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||37.3|17.1|<.0001
71047262|NCT02037165|141603646|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.99|STANDARD_ERROR_OF_MEAN|1.124|||TWO_SIDED|95.0|-3.2|1.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-3.2|
71012261|NCT05664672|141531723|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|22.4|||<|0.0001|TWO_SIDED|95.0|14.9|33.7|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||33.7|14.9|<.0001
71012262|NCT05664672|141531723|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|16.5|||<|0.0001|TWO_SIDED|95.0|10.8|25.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||25.3|10.8|<.0001
71012263|NCT05664672|141531723|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|147.0||||0.1148|TWO_SIDED|95.0|93.7|230.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||230|93.7|0.1148
71012264|NCT05664672|141531723|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|153.0||||0.044|TWO_SIDED|95.0|101.0|233.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||233|101|0.0440
71012265|NCT05664672|141531723|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|136.0||||0.2422|TWO_SIDED|95.0|87.8|210.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||210|87.8|0.2422
71012266|NCT05664672|141531724|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|49.9||||0.0994|TWO_SIDED|95.0|22.7|110.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||110|22.7|0.0994
71012267|NCT05664672|141531724|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|65.8||||0.4162|TWO_SIDED|95.0|32.0|135.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||135|32.0|0.4162
71012268|NCT05664672|141531724|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|101.0||||1|TWO_SIDED|95.0|47.5|215.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||215|47.5|1.0000
71012269|NCT05664672|141531724|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|2.23|||<|0.0001|TWO_SIDED|95.0|1.01|4.94|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||4.94|1.01|<.0001
71047263|NCT02037165|141603646|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.45|STANDARD_ERROR_OF_MEAN|1.1238|||TWO_SIDED|95.0|-3.7|0.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.8|-3.7|
71012270|NCT05664672|141531724|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|2230.0|||<|0.0001|TWO_SIDED|95.0|965.0|5160.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||5160|965|<.0001
71012271|NCT05664672|141531724|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|2940.0|||<|0.0001|TWO_SIDED|95.0|1350.0|6400.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||6400|1350|<.0001
71012272|NCT05664672|141531724|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|4530.0|||<|0.0001|TWO_SIDED|95.0|2020.0|10200.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||10200|2020|<.0001
71012273|NCT05664672|141531725|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|5.69|||<|0.0001|TWO_SIDED|95.0|3.29|9.87|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||9.87|3.29|<.0001
71012274|NCT05664672|141531725|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|8.08|||<|0.0001|TWO_SIDED|95.0|4.88|13.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||13.4|4.88|<.0001
71012275|NCT05664672|141531725|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|6.58|||<|0.0001|TWO_SIDED|95.0|3.88|11.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||11.2|3.88|<.0001
71012276|NCT05664672|141531725|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|6.03|||<|0.0001|TWO_SIDED|95.0|3.46|10.5|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||10.5|3.46|<.0001
71012277|NCT05664672|141531725|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|94.4||||0.9972|TWO_SIDED|95.0|52.7|169.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||169|52.7|0.9972
71012278|NCT05664672|141531725|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|134.0||||0.4655|TWO_SIDED|95.0|77.9|230.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||230|77.9|0.4655
70928719|NCT04800211|141353086|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-44.657||||0.0967|TWO_SIDED|95.0|-97.481|8.167|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||8.167|-97.481|0.0967
70928720|NCT04800211|141353086|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-28.974||||0.4198|TWO_SIDED|95.0|-99.915|41.966|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||41.966|-99.915|0.4198
70928721|NCT04800211|141353086|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-33.141||||0.2121|TWO_SIDED|95.0|-85.475|19.193|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||19.193|-85.475|0.2121
70928722|NCT04800211|141353086|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|15.799||||0.5445|TWO_SIDED|95.0|-35.614|67.212|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||67.212|-35.614|0.5445
70928723|NCT04800211|141353086|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.583||||0.9534|TWO_SIDED|95.0|-51.951|55.116|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||55.116|-51.951|0.9534
71103859|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3659|STANDARD_ERROR_OF_MEAN|0.45708||0.429|TWO_SIDED|95.0|-0.563|1.2948|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||1.2948|-0.5630|0.429
71103860|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0395|STANDARD_ERROR_OF_MEAN|0.49321||0.937|TWO_SIDED|95.0|-0.9628|1.0419|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||1.0419|-0.9628|0.937
71012279|NCT05664672|141531725|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|109.0||||0.9851|TWO_SIDED|95.0|62.1|192.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||192|62.1|0.9851
71012280|NCT05664672|141531726|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|13.7|||<|0.0001|TWO_SIDED|95.0|9.72|19.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||19.2|9.72|<.0001
71012281|NCT05664672|141531726|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|16.6|||<|0.0001|TWO_SIDED|95.0|12.1|22.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||22.6|12.1|<.0001
71012282|NCT05664672|141531726|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|13.4|||<|0.0001|TWO_SIDED|95.0|9.68|18.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||18.6|9.68|<.0001
71012283|NCT05664672|141531726|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|15.7|||<|0.0001|TWO_SIDED|95.0|11.2|22.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||22.2|11.2|<.0001
71012284|NCT05664672|141531726|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|86.8||||0.7167|TWO_SIDED|95.0|60.6|124.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||124|60.6|0.7167
71012285|NCT05664672|141531726|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|105.0||||0.9864|TWO_SIDED|95.0|75.3|147.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||147|75.3|0.9864
71047264|NCT02037165|141603646|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.06|STANDARD_ERROR_OF_MEAN|1.1236|||TWO_SIDED|95.0|-3.3|1.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-3.3|
71047265|NCT02037165|141603646|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|1.1236|||TWO_SIDED|95.0|-2.3|2.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.1|-2.3|
71047266|NCT02037165|141603646|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.08|STANDARD_ERROR_OF_MEAN|1.1236|||TWO_SIDED|95.0|-2.3|2.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.1|-2.3|
71047267|NCT02037165|141603646|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.5|STANDARD_ERROR_OF_MEAN|1.1238|||TWO_SIDED|95.0|-3.7|0.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.7|-3.7|
71077860|NCT02913105|141664397|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.5873|TWO_SIDED|90.0|0.94|1.13|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 42||1.13|0.94|0.5873
71012286|NCT05664672|141531726|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|85.1||||0.5911|TWO_SIDED|95.0|60.1|120.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||120|60.1|0.5911
71047268|NCT02037165|141603646|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.05|STANDARD_ERROR_OF_MEAN|1.124|||TWO_SIDED|95.0|-3.3|1.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-3.3|
71047269|NCT02037165|141603646|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.07|STANDARD_ERROR_OF_MEAN|1.1242|||TWO_SIDED|95.0|-2.3|2.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.1|-2.3|
71103861|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7902|STANDARD_ERROR_OF_MEAN|0.46847||0.101|TWO_SIDED|95.0|-0.1618|1.7423|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||1.7423|-0.1618|0.101
71103862|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4404|STANDARD_ERROR_OF_MEAN|0.43756||0.321|TWO_SIDED|95.0|-1.3296|0.4488|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.4488|-1.3296|0.321
71012287|NCT05664672|141531727|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|29.6|||<|0.0001|TWO_SIDED|95.0|21.8|40.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||40.0|21.8|<.0001
71012288|NCT05664672|141531727|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|28.3|||<|0.0001|TWO_SIDED|95.0|21.5|37.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||37.4|21.5|<.0001
71012289|NCT05664672|141531727|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|33.1|||<|0.0001|TWO_SIDED|95.0|24.8|44.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||44.2|24.8|<.0001
71012290|NCT05664672|141531727|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|37.5|||<|0.0001|TWO_SIDED|95.0|27.7|50.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||50.9|27.7|<.0001
71012291|NCT05664672|141531727|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|78.8||||0.195|TWO_SIDED|95.0|57.3|108.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||108|57.3|0.1950
71012292|NCT05664672|141531727|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|75.5||||0.0699|TWO_SIDED|95.0|56.1|102.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||102|56.1|0.0699
71012293|NCT05664672|141531727|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|88.3||||0.7041|TWO_SIDED|95.0|64.7|120.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||120|64.7|0.7041
71012294|NCT05664672|141531728|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|13.3|||<|0.0001|TWO_SIDED|95.0|9.57|18.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||18.4|9.57|<.0001
71012295|NCT05664672|141531728|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|13.3|||<|0.0001|TWO_SIDED|95.0|9.84|17.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||17.9|9.84|<.0001
71047270|NCT02037165|141603646|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.35|STANDARD_ERROR_OF_MEAN|1.0986|||TWO_SIDED|95.0|-2.5|1.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.8|-2.5|
71047271|NCT02037165|141603646|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.31|STANDARD_ERROR_OF_MEAN|1.0985|||TWO_SIDED|95.0|-4.5|-0.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-0.2|-4.5|
71047272|NCT02037165|141603646|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.39|STANDARD_ERROR_OF_MEAN|1.0984|||TWO_SIDED|95.0|-3.6|0.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.8|-3.6|
71047273|NCT02037165|141603646|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.38|STANDARD_ERROR_OF_MEAN|1.0984|||TWO_SIDED|95.0|-3.5|0.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.8|-3.5|
71047274|NCT02037165|141603646|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.15|STANDARD_ERROR_OF_MEAN|1.0983|||TWO_SIDED|95.0|-3.3|1.0|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.0|-3.3|
71047275|NCT02037165|141603646|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.63|STANDARD_ERROR_OF_MEAN|1.0984|||TWO_SIDED|95.0|-2.8|1.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.5|-2.8|
71077861|NCT02913105|141664397|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.01||||0.905|TWO_SIDED|90.0|0.92|1.1|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 84||1.10|0.92|0.9050
71077862|NCT02913105|141664397|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.05||||0.1458|TWO_SIDED|90.0|0.99|1.11|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 42||1.11|0.99|0.1458
71077863|NCT02913105|141664397|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.05||||0.2048|TWO_SIDED|90.0|0.98|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 84||1.12|0.98|0.2048
71077864|NCT02913105|141664397|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.06||||0.1051|TWO_SIDED|90.0|1.0|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 42||1.12|1.00|0.1051
71012296|NCT05664672|141531728|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|13.6|||<|0.0001|TWO_SIDED|95.0|9.93|18.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||18.6|9.93|<.0001
71012297|NCT05664672|141531728|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|9.28|||<|0.0001|TWO_SIDED|95.0|6.67|12.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||12.9|6.67|<.0001
71012298|NCT05664672|141531728|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|143.0||||0.0404|TWO_SIDED|95.0|101.0|202.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||202|101|0.0404
71012299|NCT05664672|141531728|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|143.0||||0.0243|TWO_SIDED|95.0|104.0|198.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||198|104|0.0243
71012300|NCT05664672|141531728|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|146.0||||0.0215|TWO_SIDED|95.0|105.0|205.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||205|105|0.0215
71012301|NCT05664672|141531729|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|5.37|||<|0.0001|TWO_SIDED|95.0|3.69|7.8|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||7.80|3.69|<.0001
71012302|NCT05664672|141531729|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|5.65|||<|0.0001|TWO_SIDED|95.0|4.01|7.96|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||7.96|4.01|<.0001
71012303|NCT05664672|141531729|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|5.61|||<|0.0001|TWO_SIDED|95.0|3.92|8.03|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||8.03|3.92|<.0001
71047276|NCT02037165|141603646|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.53|STANDARD_ERROR_OF_MEAN|1.0984|||TWO_SIDED|95.0|-3.7|0.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.6|-3.7|
71047277|NCT02037165|141603646|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.96|STANDARD_ERROR_OF_MEAN|1.0985|||TWO_SIDED|95.0|-3.1|1.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-3.1|
71012304|NCT05664672|141531729|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|6.09|||<|0.0001|TWO_SIDED|95.0|4.17|8.89|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||8.89|4.17|<.0001
71012305|NCT05664672|141531729|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|88.1||||0.8335|TWO_SIDED|95.0|59.4|131.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||131|59.4|0.8335
71077865|NCT02913105|141664397|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.08||||0.0717|TWO_SIDED|90.0|1.01|1.15|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 84||1.15|1.01|0.0717
70928724|NCT04800211|141353086|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|7.584||||0.8366|TWO_SIDED|95.0|-65.126|80.295|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||80.295|-65.126|0.8366
71012306|NCT05664672|141531729|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|92.9||||0.9622|TWO_SIDED|95.0|64.2|134.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||134|64.2|0.9622
71012307|NCT05664672|141531729|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|92.1||||0.9531|TWO_SIDED|95.0|62.8|135.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||135|62.8|0.9531
71047278|NCT02037165|141603646|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.76|STANDARD_ERROR_OF_MEAN|1.0986|||TWO_SIDED|95.0|-1.4|2.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.9|-1.4|
71012308|NCT05664672|141531730|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|18.0|||<|0.0001|TWO_SIDED|95.0|14.4|22.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||22.3|14.4|<.0001
71012309|NCT05664672|141531730|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|18.0|||<|0.0001|TWO_SIDED|95.0|14.8|22.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||22.1|14.8|<.0001
71012310|NCT05664672|141531730|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|15.8|||<|0.0001|TWO_SIDED|95.0|12.8|19.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||19.4|12.8|<.0001
71012311|NCT05664672|141531730|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|18.2|||<|0.0001|TWO_SIDED|95.0|14.6|22.7|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||22.7|14.6|<.0001
71047279|NCT02037165|141603647|SUPERIORITY_OR_OTHER||adjusted mean difference|-6.13|STANDARD_ERROR_OF_MEAN|3.2064|||TWO_SIDED|95.0|-12.5|0.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.2|-12.5|
71047280|NCT02037165|141603647|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.88|STANDARD_ERROR_OF_MEAN|3.4032|||TWO_SIDED|95.0|-10.6|2.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.9|-10.6|
71077866|NCT02913105|141664397|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.01||||0.8083|TWO_SIDED|90.0|0.96|1.06|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 42||1.06|0.96|0.8083
71012312|NCT05664672|141531730|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|98.4||||0.9993|TWO_SIDED|95.0|78.2|124.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||124|78.2|0.9993
71012313|NCT05664672|141531730|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|98.9||||0.9998|TWO_SIDED|95.0|79.7|123.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||123|79.7|0.9998
71012314|NCT05664672|141531730|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|86.4||||0.3019|TWO_SIDED|95.0|69.1|108.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||108|69.1|0.3019
71012315|NCT05664672|141531731|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|18.3|||<|0.0001|TWO_SIDED|95.0|13.2|25.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||25.3|13.2|<.0001
71012316|NCT05664672|141531731|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|23.7|||<|0.0001|TWO_SIDED|95.0|17.6|31.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||31.9|17.6|<.0001
71012317|NCT05664672|141531731|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|19.3|||<|0.0001|TWO_SIDED|95.0|14.2|26.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||26.4|14.2|<.0001
71012318|NCT05664672|141531731|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|24.0|||<|0.0001|TWO_SIDED|95.0|17.3|33.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||33.3|17.3|<.0001
71047281|NCT02037165|141603647|SUPERIORITY_OR_OTHER||adjusted mean difference|-6.67|STANDARD_ERROR_OF_MEAN|3.3393|||TWO_SIDED|95.0|-13.3|0.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-0.0|-13.3|
71047282|NCT02037165|141603647|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.8|STANDARD_ERROR_OF_MEAN|3.5727|||TWO_SIDED|95.0|-8.9|5.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||5.3|-8.9|
71012319|NCT05664672|141531731|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|76.1||||0.153|TWO_SIDED|95.0|54.0|107.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||107|54.0|0.1530
71047283|NCT02037165|141603647|SUPERIORITY_OR_OTHER||adjusted mean difference|-4.43|STANDARD_ERROR_OF_MEAN|3.1554|||TWO_SIDED|95.0|-10.7|1.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.8|-10.7|
71103863|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4685|STANDARD_ERROR_OF_MEAN|0.47214||0.328|TWO_SIDED|95.0|-1.428|0.491|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.4910|-1.4280|0.328
71047284|NCT02037165|141603647|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.18|STANDARD_ERROR_OF_MEAN|2.6161|||TWO_SIDED|95.0|-6.4|4.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.0|-6.4|
71047285|NCT02037165|141603647|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.35|STANDARD_ERROR_OF_MEAN|3.1849|||TWO_SIDED|95.0|-8.7|4.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.0|-8.7|
71047286|NCT02037165|141603647|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.78|STANDARD_ERROR_OF_MEAN|3.7688|||TWO_SIDED|95.0|-10.3|4.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.7|-10.3|
71047287|NCT02037165|141603647|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.27|STANDARD_ERROR_OF_MEAN|2.857|||TWO_SIDED|95.0|-7.0|4.4|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.4|-7.0|
71047288|NCT02037165|141603647|SUPERIORITY_OR_OTHER||adjusted mean difference|-6.91|STANDARD_ERROR_OF_MEAN|3.1527|||TWO_SIDED|95.0|-13.2|-0.07|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-.07|-13.2|
71047289|NCT02037165|141603647|SUPERIORITY_OR_OTHER||adjusted mean difference|-4.22|STANDARD_ERROR_OF_MEAN|3.3457|||TWO_SIDED|95.0|-10.9|2.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.4|-10.9|
71047290|NCT02037165|141603647|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.61|STANDARD_ERROR_OF_MEAN|3.2806|||TWO_SIDED|95.0|-10.1|2.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.9|-10.1|
71047291|NCT02037165|141603647|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.8|STANDARD_ERROR_OF_MEAN|3.5078|||TWO_SIDED|95.0|-7.8|6.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||6.2|-7.8|
71047292|NCT02037165|141603647|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.05|STANDARD_ERROR_OF_MEAN|3.0965|||TWO_SIDED|95.0|-6.2|6.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||6.1|-6.2|
71079476|NCT00482170|141666449|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.09|TWO_SIDED|95.0|0.95|1.95||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.95|0.95|0.090
71047293|NCT02037165|141603647|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.05|STANDARD_ERROR_OF_MEAN|2.5649|||TWO_SIDED|95.0|-6.1|4.0|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.0|-6.1|
71047294|NCT02037165|141603647|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.59|STANDARD_ERROR_OF_MEAN|3.125|||TWO_SIDED|95.0|-8.8|3.7|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.7|-8.8|
71047295|NCT02037165|141603647|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.84|STANDARD_ERROR_OF_MEAN|3.7013|||TWO_SIDED|95.0|-11.2|3.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.5|-11.2|
71047296|NCT02037165|141603647|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.05|STANDARD_ERROR_OF_MEAN|2.8201|||TWO_SIDED|95.0|-8.7|2.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.6|-8.7|
71047297|NCT02037165|141603648|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.78|STANDARD_ERROR_OF_MEAN|2.5753|||TWO_SIDED|95.0|-8.9|1.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.3|-8.9|
71047298|NCT02037165|141603648|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.74|STANDARD_ERROR_OF_MEAN|2.5162|||TWO_SIDED|95.0|-9.8|0.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.3|-9.8|
71047299|NCT02037165|141603648|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.06|STANDARD_ERROR_OF_MEAN|2.9156|||TWO_SIDED|95.0|-11.9|-0.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-0.3|-11.9|
71047300|NCT02037165|141603648|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.83|STANDARD_ERROR_OF_MEAN|3.4987|||TWO_SIDED|95.0|-13.8|0.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.1|-13.8|
71047301|NCT02037165|141603648|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.24|STANDARD_ERROR_OF_MEAN|3.6922|||TWO_SIDED|95.0|-12.6|2.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.1|-12.6|
71079477|NCT00482170|141666449|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.154|TWO_SIDED|95.0|0.9|1.91||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.91|0.90|0.154
71047302|NCT02037165|141603648|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.71|STANDARD_ERROR_OF_MEAN|3.6166|||TWO_SIDED|95.0|-11.9|2.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-11.9|
71047303|NCT02037165|141603648|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.09|STANDARD_ERROR_OF_MEAN|3.7073|||TWO_SIDED|95.0|-10.5|4.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.3|-10.5|
71047304|NCT02037165|141603648|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.82|STANDARD_ERROR_OF_MEAN|4.186|||TWO_SIDED|95.0|-12.1|4.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.5|-12.1|
71047305|NCT02037165|141603648|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.67|STANDARD_ERROR_OF_MEAN|3.4254|||TWO_SIDED|95.0|-9.5|4.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.1|-9.5|
71047306|NCT02037165|141603648|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.64|STANDARD_ERROR_OF_MEAN|2.5461|||TWO_SIDED|95.0|-8.7|1.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.4|-8.7|
71047307|NCT02037165|141603648|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.46|STANDARD_ERROR_OF_MEAN|2.4848|||TWO_SIDED|95.0|-7.4|2.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-7.4|
71047308|NCT02037165|141603648|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.27|STANDARD_ERROR_OF_MEAN|2.8811|||TWO_SIDED|95.0|-9.0|2.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-9.0|
71047309|NCT02037165|141603648|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.91|STANDARD_ERROR_OF_MEAN|3.4569|||TWO_SIDED|95.0|-9.8|4.0|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.0|-9.8|
71047310|NCT02037165|141603648|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.27|STANDARD_ERROR_OF_MEAN|3.6471|||TWO_SIDED|95.0|-7.0|7.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||7.5|-7.0|
71047311|NCT02037165|141603648|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.27|STANDARD_ERROR_OF_MEAN|3.5708|||TWO_SIDED|95.0|-9.4|4.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.8|-9.4|
71047312|NCT02037165|141603648|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.21|STANDARD_ERROR_OF_MEAN|3.6602|||TWO_SIDED|95.0|-11.5|3.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.1|-11.5|
71047313|NCT02037165|141603648|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.54|STANDARD_ERROR_OF_MEAN|4.1389|||TWO_SIDED|95.0|-7.7|8.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||8.8|-7.7|
71047314|NCT02037165|141603648|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.04|STANDARD_ERROR_OF_MEAN|3.3835|||TWO_SIDED|95.0|-8.8|4.7|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.7|-8.8|
71047315|NCT02037165|141603649|SUPERIORITY_OR_OTHER||adjusted mean difference|-29.67|STANDARD_ERROR_OF_MEAN|29.5691|||TWO_SIDED|95.0|-88.3|29.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||29.0|-88.3|
71047316|NCT02037165|141603649|SUPERIORITY_OR_OTHER||adjusted mean difference|-16.29|STANDARD_ERROR_OF_MEAN|29.8613|||TWO_SIDED|95.0|-75.5|42.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||42.9|-75.5|
71047317|NCT02037165|141603649|SUPERIORITY_OR_OTHER||adjusted mean difference|7.63|STANDARD_ERROR_OF_MEAN|25.1035|||TWO_SIDED|95.0|-42.2|57.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||57.5|-42.2|
71047318|NCT02037165|141603649|SUPERIORITY_OR_OTHER||adjusted mean difference|-20.47|STANDARD_ERROR_OF_MEAN|23.311|||TWO_SIDED|95.0|-66.7|25.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||25.8|-66.7|
71077867|NCT02913105|141664397|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.02||||0.5361|TWO_SIDED|90.0|0.96|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 84||1.09|0.96|0.5361
71012320|NCT05664672|141531731|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|98.6||||0.9999|TWO_SIDED|95.0|71.7|136.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||136|71.7|0.9999
71012321|NCT05664672|141531731|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|80.5||||0.3025|TWO_SIDED|95.0|57.8|112.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||112|57.8|0.3025
71012322|NCT05664672|141531732|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|22.7|||<|0.0001|TWO_SIDED|95.0|17.0|30.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||30.4|17.0|<.0001
71012323|NCT05664672|141531732|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|28.1|||<|0.0001|TWO_SIDED|95.0|21.6|36.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||36.6|21.6|<.0001
71012324|NCT05664672|141531732|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|27.5|||<|0.0001|TWO_SIDED|95.0|20.8|36.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||36.2|20.8|<.0001
71012325|NCT05664672|141531732|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|28.7|||<|0.0001|TWO_SIDED|95.0|21.4|38.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||38.4|21.4|<.0001
71012326|NCT05664672|141531732|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|79.4||||0.1843|TWO_SIDED|95.0|58.6|108.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||108|58.6|0.1843
71012327|NCT05664672|141531732|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|98.1||||0.9994|TWO_SIDED|95.0|73.9|130.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||130|73.9|0.9994
71012328|NCT05664672|141531732|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|95.9||||0.9891|TWO_SIDED|95.0|71.4|129.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||129|71.4|0.9891
71012329|NCT05664672|141531733|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|37.3|||<|0.0001|TWO_SIDED|95.0|30.4|45.7|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||45.7|30.4|<.0001
71012330|NCT05664672|141531733|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|44.0|||<|0.0001|TWO_SIDED|95.0|36.5|53.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||53.1|36.5|<.0001
71012331|NCT05664672|141531733|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|41.8|||<|0.0001|TWO_SIDED|95.0|34.4|50.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||50.9|34.4|<.0001
71012332|NCT05664672|141531733|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|42.9|||<|0.0001|TWO_SIDED|95.0|34.9|52.7|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||52.7|34.9|<.0001
71012333|NCT05664672|141531733|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|86.9||||0.3027|TWO_SIDED|95.0|70.0|108.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||108|70.0|0.3027
71012334|NCT05664672|141531733|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|103.0||||0.9926|TWO_SIDED|95.0|83.9|125.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||125|83.9|0.9926
71012335|NCT05664672|141531733|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|97.5||||0.9938|TWO_SIDED|95.0|79.1|120.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||120|79.1|0.9938
71012336|NCT05664672|141531734|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|46.3|||<|0.0001|TWO_SIDED|95.0|39.5|54.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||54.4|39.5|<.0001
71012337|NCT05664672|141531734|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|55.6|||<|0.0001|TWO_SIDED|95.0|48.0|64.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||64.4|48.0|<.0001
71012338|NCT05664672|141531734|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|52.7|||<|0.0001|TWO_SIDED|95.0|45.2|61.5|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||61.5|45.2|<.0001
71012339|NCT05664672|141531734|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|54.9|||<|0.0001|TWO_SIDED|95.0|46.7|64.5|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||64.5|46.7|<.0001
71047319|NCT02037165|141603649|SUPERIORITY_OR_OTHER||adjusted mean difference|-12.63|STANDARD_ERROR_OF_MEAN|23.1894|||TWO_SIDED|95.0|-58.6|33.4|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||33.4|-58.6|
71047320|NCT02037165|141603649|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.67|STANDARD_ERROR_OF_MEAN|23.7285|||TWO_SIDED|95.0|-47.8|46.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||46.5|-47.8|
71047321|NCT02037165|141603649|SUPERIORITY_OR_OTHER||adjusted mean difference|-19.27|STANDARD_ERROR_OF_MEAN|27.6359|||TWO_SIDED|95.0|-74.3|35.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||35.7|-74.3|
71079478|NCT00482170|141666449|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.037|TWO_SIDED|95.0|1.02|2.22||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.22|1.02|0.037
71012340|NCT05664672|141531734|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|84.4||||0.0504|TWO_SIDED|95.0|71.2|100.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||100|71.2|0.0504
71012341|NCT05664672|141531734|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|101.0||||0.9988|TWO_SIDED|95.0|86.4|119.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||119|86.4|0.9988
71012342|NCT05664672|141531734|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|96.0||||0.9238|TWO_SIDED|95.0|81.4|113.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||113|81.4|0.9238
71012343|NCT05664672|141531735|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|3.71|||<|0.0001|TWO_SIDED|95.0|1.88|7.31|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||7.31|1.88|<.0001
71012344|NCT05664672|141531735|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|4.25|||<|0.0001|TWO_SIDED|95.0|2.28|7.93|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||7.93|2.28|<.0001
71012345|NCT05664672|141531735|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|4.24|||<|0.0001|TWO_SIDED|95.0|2.2|8.14|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||8.14|2.20|<.0001
71012346|NCT05664672|141531735|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|6.4|||<|0.0001|TWO_SIDED|95.0|3.22|12.7|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||12.7|3.22|<.0001
71012347|NCT05664672|141531735|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|57.9||||0.184|TWO_SIDED|95.0|28.3|119.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||119|28.3|0.1840
71012348|NCT05664672|141531735|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|66.4||||0.3552|TWO_SIDED|95.0|34.0|130.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||130|34.0|0.3552
71012349|NCT05664672|141531735|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|66.2||||0.381|TWO_SIDED|95.0|33.0|133.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||133|33.0|0.3810
71012350|NCT05664672|141531736|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|16.8|||<|0.0001|TWO_SIDED|95.0|13.0|21.8|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||21.8|13.0|<.0001
71012351|NCT05664672|141531736|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|20.5|||<|0.0001|TWO_SIDED|95.0|16.2|25.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||25.9|16.2|<.0001
71012352|NCT05664672|141531736|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|18.2|||<|0.0001|TWO_SIDED|95.0|14.3|23.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||23.4|14.3|<.0001
71012353|NCT05664672|141531736|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|17.8|||<|0.0001|TWO_SIDED|95.0|13.7|23.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||23.1|13.7|<.0001
71047322|NCT02037165|141603649|SUPERIORITY_OR_OTHER||adjusted mean difference|-25.23|STANDARD_ERROR_OF_MEAN|27.5524|||TWO_SIDED|95.0|-79.9|29.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||29.5|-79.9|
71047323|NCT02037165|141603649|SUPERIORITY_OR_OTHER||adjusted mean difference|-17.19|STANDARD_ERROR_OF_MEAN|27.0135|||TWO_SIDED|95.0|-70.9|36.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||36.5|-70.9|
71047324|NCT02037165|141603649|SUPERIORITY_OR_OTHER||adjusted mean difference|-39.62|STANDARD_ERROR_OF_MEAN|29.3023|||TWO_SIDED|95.0|-97.7|18.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||18.5|-97.7|
71047325|NCT02037165|141603649|SUPERIORITY_OR_OTHER||adjusted mean difference|-37.06|STANDARD_ERROR_OF_MEAN|29.5797|||TWO_SIDED|95.0|-95.7|21.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||21.6|-95.7|
71047326|NCT02037165|141603649|SUPERIORITY_OR_OTHER||adjusted mean difference|-52.45|STANDARD_ERROR_OF_MEAN|24.8429|||TWO_SIDED|95.0|-101.8|-3.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-3.1|-101.8|
71047327|NCT02037165|141603649|SUPERIORITY_OR_OTHER||adjusted mean difference|-59.87|STANDARD_ERROR_OF_MEAN|23.0541|||TWO_SIDED|95.0|-105.6|-14.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-14.1|-105.6|
71047328|NCT02037165|141603649|SUPERIORITY_OR_OTHER||adjusted mean difference|-39.96|STANDARD_ERROR_OF_MEAN|22.9336|||TWO_SIDED|95.0|-85.5|5.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||5.5|-85.5|
71047329|NCT02037165|141603649|SUPERIORITY_OR_OTHER||adjusted mean difference|-38.99|STANDARD_ERROR_OF_MEAN|23.4683|||TWO_SIDED|95.0|-85.6|7.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||7.6|-85.6|
71012354|NCT05664672|141531736|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|94.5||||0.9589|TWO_SIDED|95.0|72.0|124.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||124|72.0|0.9589
71012355|NCT05664672|141531736|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|115.0||||0.4442|TWO_SIDED|95.0|89.3|148.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||148|89.3|0.4442
71012356|NCT05664672|141531736|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|103.0||||0.9975|TWO_SIDED|95.0|78.8|133.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||133|78.8|0.9975
71012357|NCT05664672|141531737|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|36.5|||<|0.0001|TWO_SIDED|95.0|23.9|55.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||55.6|23.9|<.0001
71012358|NCT05664672|141531737|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|39.9|||<|0.0001|TWO_SIDED|95.0|27.1|59.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||59.0|27.1|<.0001
71012359|NCT05664672|141531737|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|30.2|||<|0.0001|TWO_SIDED|95.0|20.1|45.5|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||45.5|20.1|<.0001
71012360|NCT05664672|141531737|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|48.9||||0.0002|TWO_SIDED|95.0|31.9|75.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||75.0|31.9|0.0002
71012361|NCT05664672|141531737|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|74.5||||0.2938|TWO_SIDED|95.0|47.6|117.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||117|47.6|0.2938
71012362|NCT05664672|141531737|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|81.6||||0.5552|TWO_SIDED|95.0|53.7|124.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||124|53.7|0.5552
71012363|NCT05664672|141531737|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|61.7||||0.0254|TWO_SIDED|95.0|39.9|95.5|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||95.5|39.9|0.0254
71012364|NCT05664672|141531738|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|52.1|||<|0.0001|TWO_SIDED|95.0|40.4|67.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||67.1|40.4|<.0001
71012365|NCT05664672|141531738|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|49.3|||<|0.0001|TWO_SIDED|95.0|39.0|62.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||62.2|39.0|<.0001
71079479|NCT00482170|141666449|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.028|TWO_SIDED|95.0|1.05|2.24||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||2.24|1.05|0.028
70928725|NCT04800211|141353086|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-55.973||||0.5437|TWO_SIDED|95.0|-154.862|42.916|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||42.916|-154.862|0.5437
70928726|NCT04800211|141353086|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-73.308||||0.2974|TWO_SIDED|95.0|-177.224|30.608|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||30.608|-177.224|0.2974
70928727|NCT04800211|141353086|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-44.892||||0.9026|TWO_SIDED|95.0|-181.909|92.126|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||92.126|-181.909|0.9026
71012366|NCT05664672|141531738|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|40.8|||<|0.0001|TWO_SIDED|95.0|32.0|52.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||52.1|32.0|<.0001
71012367|NCT05664672|141531738|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|45.9|||<|0.0001|TWO_SIDED|95.0|35.7|59.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||59.2|35.7|<.0001
71012368|NCT05664672|141531738|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|113.0||||0.5817|TWO_SIDED|95.0|86.8|148.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||148|86.8|0.5817
71012369|NCT05664672|141531738|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|107.0||||0.8852|TWO_SIDED|95.0|83.7|138.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||138|83.7|0.8852
71012370|NCT05664672|141531738|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|88.9||||0.607|TWO_SIDED|95.0|68.7|115.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||115|68.7|0.6070
71012371|NCT05664672|141531739|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|13.2|||<|0.0001|TWO_SIDED|95.0|5.44|32.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||32.0|5.44|<.0001
71103864|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|0.42|STANDARD_ERROR_OF_MEAN|0.44846||0.356|TWO_SIDED|95.0|-0.4914|1.3314|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||1.3314|-0.4914|0.356
71012372|NCT05664672|141531739|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|23.8|||<|0.0001|TWO_SIDED|95.0|10.7|53.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||53.3|10.7|<.0001
71012373|NCT05664672|141531739|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|24.7||||0.0003|TWO_SIDED|95.0|10.6|57.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||57.4|10.6|0.0003
71012374|NCT05664672|141531739|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|22.3||||0.0002|TWO_SIDED|95.0|9.21|54.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||54.1|9.21|0.0002
71012375|NCT05664672|141531739|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|59.1||||0.428|TWO_SIDED|95.0|23.3|150.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||150|23.3|0.4280
71012376|NCT05664672|141531739|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|107.0||||0.999|TWO_SIDED|95.0|44.8|255.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||255|44.8|0.9990
71012377|NCT05664672|141531739|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|110.0||||0.9958|TWO_SIDED|95.0|44.9|272.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||272|44.9|0.9958
71012378|NCT05664672|141531740|SUPERIORITY||Ratio of geometric LS means|-50.8|||<|0.0001|TWO_SIDED|95.0|-77.7|-23.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||-23.9|-77.7|<.0001
71012379|NCT05664672|141531740|SUPERIORITY||Ratio of geometric LS means|-45.0|||<|0.0001|TWO_SIDED|95.0|-69.6|-20.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||-20.3|-69.6|<.0001
71012380|NCT05664672|141531740|SUPERIORITY||Ratio of geometric LS means|-42.3||||0.0003|TWO_SIDED|95.0|-68.2|-16.5|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||-16.5|-68.2|0.0003
71012381|NCT05664672|141531740|SUPERIORITY||Ratio of geometric LS means|-44.8||||0.0004|TWO_SIDED|95.0|-72.6|-17.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||-17.0|-72.6|0.0004
71012382|NCT05664672|141531740|SUPERIORITY||Ratio of geometric LS means|-6.05||||0.9551|TWO_SIDED|95.0|-35.2|23.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||23.1|-35.2|0.9551
71047330|NCT02037165|141603649|SUPERIORITY_OR_OTHER||adjusted mean difference|-63.69|STANDARD_ERROR_OF_MEAN|27.3484|||TWO_SIDED|95.0|-118.1|-9.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-9.3|-118.1|
71012383|NCT05664672|141531740|SUPERIORITY||Ratio of geometric LS means|-0.198||||1|TWO_SIDED|95.0|-27.3|26.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||26.9|-27.3|1.0000
71012384|NCT05664672|141531740|SUPERIORITY||Ratio of geometric LS means|2.48||||0.9981|TWO_SIDED|95.0|-25.6|30.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||30.6|-25.6|0.9981
71012385|NCT05664672|141531741|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|31.7|||<|0.0001|TWO_SIDED|95.0|18.7|53.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||53.9|18.7|<.0001
71012386|NCT05664672|141531741|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|28.5|||<|0.0001|TWO_SIDED|95.0|17.6|46.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||46.2|17.6|<.0001
71012387|NCT05664672|141531741|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|24.3|||<|0.0001|TWO_SIDED|95.0|14.7|40.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||40.2|14.7|<.0001
71012388|NCT05664672|141531741|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|28.1|||<|0.0001|TWO_SIDED|95.0|16.6|47.7|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||47.7|16.6|<.0001
71012389|NCT05664672|141531741|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|113.0||||0.9511|TWO_SIDED|95.0|64.7|197.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||197|64.7|0.9511
71012390|NCT05664672|141531741|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|101.0||||1|TWO_SIDED|95.0|60.4|170.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||170|60.4|1.0000
71012391|NCT05664672|141531741|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|86.5||||0.9003|TWO_SIDED|95.0|50.6|148.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||148|50.6|0.9003
71012392|NCT05664672|141531742|SUPERIORITY||Ratio of geometric LS means|46.4|||<|0.0001|TWO_SIDED|95.0|37.1|58.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||58.0|37.1|<.0001
71012393|NCT05664672|141531742|SUPERIORITY||Ratio of geometric LS means|43.1|||<|0.0001|TWO_SIDED|95.0|35.1|52.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||52.9|35.1|<.0001
71012394|NCT05664672|141531742|SUPERIORITY||Ratio of geometric LS means|44.1|||<|0.0001|TWO_SIDED|95.0|35.5|54.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||54.6|35.5|<.0001
71012395|NCT05664672|141531742|SUPERIORITY||Ratio of geometric LS means|39.1|||<|0.0001|TWO_SIDED|95.0|31.0|49.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||49.4|31.0|<.0001
71077868|NCT02913105|141664398|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.0858|TWO_SIDED|90.0|0.92|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 7||1.00|0.92|0.0858
71012396|NCT05664672|141531742|SUPERIORITY||Ratio of geometric LS means|119.0||||0.2351|TWO_SIDED|95.0|93.2|151.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||151|93.2|0.2351
71012397|NCT05664672|141531742|SUPERIORITY||Ratio of geometric LS means|110.0||||0.657|TWO_SIDED|95.0|87.7|138.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||138|87.7|0.6570
71047331|NCT02037165|141603649|SUPERIORITY_OR_OTHER||adjusted mean difference|-61.36|STANDARD_ERROR_OF_MEAN|27.2866|||TWO_SIDED|95.0|-115.6|-7.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-7.2|-115.6|
71047332|NCT02037165|141603649|SUPERIORITY_OR_OTHER||adjusted mean difference|-49.4|STANDARD_ERROR_OF_MEAN|26.7541|||TWO_SIDED|95.0|-102.6|3.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.8|-102.6|
71047333|NCT00532935|141603650|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47|STANDARD_DEVIATION|1.1|<|0.001|TWO_SIDED|95.0|-0.66|-0.28|||ANCOVA|ANCOVA model included a term for treatment and a covariate for the baseline A1C value.||||-0.28|-0.66|<0.001
71047334|NCT00532935|141603651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-27.6|STANDARD_DEVIATION|29.1|<|0.001|TWO_SIDED|95.0|-32.7|-22.4|||ANCOVA|ANCOVA model included a term for treatment and a covariate for the baseline FPG value.||||-22.4|-32.7|<0.001
71047335|NCT00532935|141603652|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.2|STANDARD_DEVIATION|59.7|<|0.001|TWO_SIDED|95.0|-32.1|-8.3|||ANCOVA|ANCOVA model included a term for treatment and a covariate for the baseline 2-hour PMG value.||||-8.3|-32.1|<0.001
71047336|NCT00532935|141603653|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.9|STANDARD_DEVIATION|40.3|<|0.001|TWO_SIDED|95.0|-19.0|-4.9|||ANCOVA|ANCOVA model included a term for treatment and a covariate for the baseline FPG value.||||-4.9|-19.0|<0.001
71047337|NCT00532935|141603654|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0|||<|0.001|TWO_SIDED|95.0|1.3|2.8||Based on a test of the odds ratio = 1, comparing the odds of having A1C \<7.0% at Week 32 in the Sitagliptin/Metformin 50/1000 mg b.i.d. group vs. the Pioglitazone 45 mg q.d. group.|Regression, Logistic|logistic regression model included a term for treatment and a covariate for the baseline A1C value.|This parameter estimate and 95% confidence interval correspond to the odds of having A1C \<7.0% at Week 32 in the Sitagliptin/Metformin 50/1000 mg b.i.d. group vs. the Pioglitazone 45 mg q.d. group.|||2.8|1.3|<0.001
71047338|NCT01568866|141603663|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.533|||<|0.0001|TWO_SIDED|95.0|0.437|0.651|||Stratified Log Rank|Log rank test stratified by the randomization stratification factors.|The hazard ratio (carfilzomib/bortezomib) was estimated using a Cox proportional hazards model stratified by prior proteasome inhibitor treatment, lines of prior treatment, ISS stage, and choice of route of bortezomib administration.|"The PFS interim analysis was to be performed using a group sequential monitoring plan.~The monitoring plan included an O'Brien-Fleming type of efficacy stopping boundary constructed using the Lan-DeMets alpha spending function to ensure a 1-sided Type I error rate ≤ 0.025."||0.651|0.437|< 0.0001
71047339|NCT01568866|141603664|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.791||||0.01|TWO_SIDED|95.0|0.648|0.964||The multiplicity in testing secondary endpoints was adjusted per group using the sequential Holm procedure to preserve the family-wise error rate at 0.025.|Stratified Log Rank|Log rank test stratified by the randomization stratification factors.|The hazard ratio (carfilzomib/bortezomib) was estimated using a Cox proportional hazards model stratified by prior proteasome inhibitor treatment, lines of prior treatment, ISS stage, and choice of route of bortezomib administration.|The second interim analysis of overall survival was to be conducted after 394 events had been reached. A one-sided significance level was determined using the O'Brien-Fleming-type α spending function based on the actual number of events (α=0.0123).||0.964|0.648|0.0100
71047340|NCT01568866|141603665|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.032|||<|0.0001|TWO_SIDED|95.0|1.519|2.718||The multiplicity in testing secondary endpoints was adjusted per group using the sequential Holm procedure to preserve the family-wise error rate at 0.025.|Stratified Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by the randomization stratification factors.|The odds ratio (carfilzomib/bortezomib) was calculated using the Cochran-Mantel-Haenszel method stratified by prior proteasome inhibitor treatment, lines of prior treatment, ISS stage, and choice of route of bortezomib administration.|||2.718|1.519|< 0.0001
71047341|NCT01568866|141603667|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.137|||<|0.0001|TWO_SIDED|95.0|0.089|0.21||The multiplicity in testing secondary endpoints was adjusted per group using the sequential Holm procedure to preserve the family-wise error rate at 0.025.|Cochran-Mantel-Haenszel||The odds ratio (carfilzomib/bortezomib) was estimated using the unconditional Cochran-Mantel-Haenszel method.|||0.210|0.089|<0.0001
71047342|NCT01698775|141603671|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.33||||0.035|TWO_SIDED|95.0|-0.63|-0.02|||ANCOVA|||||-0.02|-0.63|0.035
71047343|NCT01698775|141603672|SUPERIORITY_OR_OTHER||Difference in percentages|-3.8|||||TWO_SIDED|95.0|-16.3|8.8|||||Based on Miettinen \& Nurminen method stratified by renal status stratum.|||8.8|-16.3|
71047344|NCT01698775|141603673|SUPERIORITY_OR_OTHER||Difference in percentages|1.9|||||TWO_SIDED|95.0|-2.6|7.2|||||Based on Miettinen \& Nurminen method stratified by renal status stratum.|||7.2|-2.6|
71047345|NCT01698775|141603674|SUPERIORITY_OR_OTHER||Difference in percentage|-0.9|||||TWO_SIDED|95.0|-12.2|10.3|||||Based on Miettinen \& Nurminen method stratified by renal status stratum.|||10.3|-12.2|
71047346|NCT01698775|141603675|SUPERIORITY_OR_OTHER||Difference in percentage|2.8|||||TWO_SIDED|95.0|-3.6|9.8||||||||9.8|-3.6|
71047347|NCT01698775|141603676|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.9||||0.54|TWO_SIDED|95.0|-16.5|8.7|||ANCOVA|||||8.7|-16.5|0.540
71047348|NCT01698775|141603679|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.4||||0.72|TWO_SIDED|95.0|-2.7|1.9|||cLDA|||||1.9|-2.7|0.720
71047349|NCT01244061|141603683|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.08|||<|0.0001|TWO_SIDED|95.0|4.34|11.55||The statistical significance was declared for each hypothesis firstly for CAR Weeks 9-12, and then secondly for CAR Weeks 9-52 until a p-value \> 0.05 was obtained, at which point the hypothesis would be declared to be not statistically significant.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||The study was conducted on a sample size to achieve at least 90% power for the treatment comparison in the primary efficacy endpoint assuming an odds ratio of 3.36 with a placebo abstinence rate of 12% and varenicline abstinence rate of 31%. The intent of the primary efficacy analysis was to evaluate the hypothesis that varenicline is superior to placebo for smoking cessation after 12 weeks of treatment.||11.55|4.34|<0.0001
71047350|NCT01244061|141603684|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.0|||<|0.0001|TWO_SIDED|95.0|3.97|20.41||Statistical significance was declared for each hypothesis in the order above until a p-value \>0.05 was obtained, at which point the hypothesis was declared to be not statistically significant.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||The sample size was sufficient to achieve 80% power for the treatment comparison in the key secondary end point for an odds ratio of 2.55 with a placebo abstinence rate of 6% and varenicline abstinence rate of 14%. The intent of the key secondary efficacy analysis was to evaluate the hypothesis that varenicline is superior to placebo for smoking cessation from Week 9 to the end of non-treatment follow up period at Week 52.||20.41|3.97|<0.0001
71047351|NCT01244061|141603685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.83|||<|0.0001|TWO_SIDED|95.0|3.25|10.44||The statistical test was two-sided and at a 0.05 level of significance. No adjustment was made for the analysis of multiple secondary endpoints.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||||10.44|3.25|<0.0001
71047352|NCT01244061|141603686|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.85|||<|0.0001|TWO_SIDED|95.0|4.92|12.51||The statistical test was two-sided and at a 0.05 level of significance. No adjustment was made for the analysis of multiple secondary endpoints.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||Week 12 assessment||12.51|4.92|<0.0001
71047353|NCT01244061|141603686|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.94|||<|0.0001|TWO_SIDED|95.0|1.86|4.64||The statistical test was two-sided and at a 0.05 level of significance. No adjustment was made for the analysis of multiple secondary endpoints.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||Week 24 assessment||4.64|1.86|<0.0001
71047354|NCT01244061|141603686|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.06|||<|0.0001|TWO_SIDED|95.0|1.88|4.97||The statistical test was two-sided and at a 0.05 level of significance. No adjustment was made for the analysis of multiple secondary endpoints.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||Week 52 assessment||4.97|1.88|<0.0001
71047359|NCT00586482|141603709|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||t-test, 2 sided|||A two-sided p value of less than or equal to 0.05 was considered statistically significant.||||0.12
71047360|NCT00586482|141603710|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||||||0.23
71047361|NCT00586482|141603711|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||||||0.29
71047362|NCT00586482|141603712|SUPERIORITY_OR_OTHER|||||||0.93|||||||t-test, 2 sided|||||||0.93
71047363|NCT00586482|141603713|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
71047364|NCT03623386|141603736|SUPERIORITY|||||||0.981|||||||Wilcoxon (Mann-Whitney)|||||||0.981
71047365|NCT03623386|141603737|SUPERIORITY|||||||0.481|||||||Wilcoxon (Mann-Whitney)|||||||0.481
71047366|NCT03623386|141603738|SUPERIORITY||||||>|0.05|||||||ANOVA|||Testing for main effects (group), time effect and the interaction of group and time.||||>0.05
71012398|NCT05664672|141531742|SUPERIORITY||Ratio of geometric LS means|113.0||||0.5112|TWO_SIDED|95.0|89.1|142.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||142|89.1|0.5112
71012399|NCT01598831|141531753|SUPERIORITY||Risk Difference (RD)|-2.55||||0.318|TWO_SIDED|95.0|-3.68|8.77||The threshold for statistical significance was a two sided 5%|Cochran-Mantel-Haenszel|CMH test controlled for the stratification factor.|Rates by Arm are 26.8% for ART-123 and 29.4% for Placebo||In a post hoc sensitivity analysis for the primary outcome that accounted for pooled site as a random effect, the adjusted 28-day all-cause mortality rate was 24.8%in the rhsTM group vs 27.5%in the placebo group (P = .31).|8.77|-3.68|0.318
71012400|NCT02260791|141531823|EQUIVALENCE|-12% to +15% equivalence margin using 90% CI around the difference in ACR20 response rate|Mean Difference (Final Values)|-1.8|||||TWO_SIDED|90.0|-7.3|3.6||||||The difference and its 90% Confidence Interval (CI) for primary endpoint between FKB327 and Humira were estimated. If the 90% CI fell entirely between pre-specified equivalence margin (-12% to +15%), then FKB327 was considered equivalent to Humira.||3.6|-7.3|
71012401|NCT02260791|141531824|EQUIVALENCE|If the 2-sided 95% CI for the difference in DAS28-CRP at Week 24 between FKB327 and Humira fell entirely between -0.6 and +0.6 then FKB327 was considered equivalent to Humira.|Difference in least square mean|0.01|||||TWO_SIDED|95.0|-0.16|0.18||||||The secondary hypothesis involved equivalence of the difference between FKB327 and Humira in DAS28-CRP at Week 24. Based on the repeated measures analysis model, the difference and its 95% CI in the least-squares means (LSMs) for DAS28-CRP at Week 24 between FKB327 and Humira were estimated. If the 95% CI fell entirely between the pre-specified margin (+/- 0.6), then FKB327 was considered equivalent to Humira.||0.18|-0.16|
71047367|NCT03623386|141603739|SUPERIORITY|||||||0.026||||||p value reflects the effect of time.|ANOVA|||Testing for main effects (group), time effect and the interaction of group and time.||||0.026
71047368|NCT04271735|141603759|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
71047369|NCT00515541|141603762|SUPERIORITY_OR_OTHER|||||||0.01||||||A P-value \<0.05 when compared to baseline is considered significant.|Wilcoxon (Mann-Whitney)|||Group B baseline vs. Group B Week 12||||0.01
71047370|NCT00515541|141603763|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The median of Groups A, B, and C grouped together was compared Baseline to Week 6.||||<0.001
71047371|NCT00515541|141603763|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||The median of Groups A, B, and C grouped together was compared Baseline to Week 12.||||<0.001
71047372|NCT00922272|141603764|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
71047373|NCT00922272|141603766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.3||||0.4182|TWO_SIDED|95.0|-3.4|8.1|||ANCOVA|||||8.1|-3.4|0.4182
71103865|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2254|STANDARD_ERROR_OF_MEAN|0.1679||0.188|TWO_SIDED|95.0|-0.5666|0.1158|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Paracingulte gyrus/BA32. Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1158|-0.5666|0.188
71047374|NCT00922272|141603767|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6705||95.0|||||Fisher Exact|||||||0.6705
71047375|NCT00922272|141603768|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Affective Flattening||||<0.0001
71012402|NCT03026556|141531856|OTHER||Hazard Ratio (HR)|0.766||||0.0844|TWO_SIDED|95.0|0.566|1.037|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.037|0.566|0.0844
71047376|NCT00922272|141603768|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Alogia||||<0.0001
71047377|NCT00922272|141603768|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Avolition-Apathy||||<0.0001
71047378|NCT00922272|141603768|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Anhedonia-Asociality||||<0.0001
71047379|NCT00922272|141603768|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Attention||||<0.0001
71047380|NCT00922272|141603769|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.8771|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||Affective Flattening||0.5|-0.4|0.8771
71047381|NCT00922272|141603769|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6||||0.0584|TWO_SIDED|95.0|0.0|1.1|||ANCOVA|||Alogia||1.1|0.0|0.0584
71047382|NCT00922272|141603769|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.5215|TWO_SIDED|95.0|-0.3|0.6|||ANCOVA|||Avolition-Apathy||0.6|-0.3|0.5215
71047383|NCT00922272|141603769|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.4835|TWO_SIDED|95.0|-0.3|0.7|||ANCOVA|||Anhedonia-Asociality||0.7|-0.3|0.4835
71047384|NCT00922272|141603769|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.5723|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||Attention||0.7|-0.4|0.5723
71047385|NCT00922272|141603770|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Positive subscale||||<0.0001
71047386|NCT00922272|141603770|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Negative subscale||||<0.0001
71047387|NCT00922272|141603770|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||General Psychopathology subscale||||<0.0001
71047388|NCT00922272|141603771|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6||||0.1975|TWO_SIDED|95.0|-0.3|1.5|||ANCOVA|||Positive subscale||1.5|-0.3|0.1975
71047389|NCT00922272|141603771|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.1228|TWO_SIDED|95.0|-0.3|2.3|||ANCOVA|||Negative subscale||2.3|-0.3|0.1228
71047390|NCT00922272|141603771|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.8||||0.1115|TWO_SIDED|95.0|-0.4|3.9|||ANCOVA|||General Psychopathology subscale||3.9|-0.4|0.1115
71047391|NCT00922272|141603778|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0307||95.0|||||t-test, 2 sided|||||||0.0307
71103866|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0232|STANDARD_ERROR_OF_MEAN|0.18117||0.899|TWO_SIDED|95.0|-0.3914|0.3449|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Paracingulte gyrus/BA32: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3449|-0.3914|0.899
71012403|NCT03026556|141531856|OTHER||Hazard Ratio (HR)|1.255||||0.4892|TWO_SIDED|95.0|0.659|2.39|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.390|0.659|0.4892
71012404|NCT03026556|141531857|OTHER||Hazard Ratio (HR)|0.82||||0.0182|TWO_SIDED|95.0|0.696|0.967|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||0.967|0.696|0.0182
71012405|NCT03026556|141531857|OTHER||Hazard Ratio (HR)|1.374||||0.0702|TWO_SIDED|95.0|0.974|1.939|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.939|0.974|0.0702
71012406|NCT03026556|141531858|OTHER||Hazard Ratio (HR)|0.923||||0.6307|TWO_SIDED|95.0|0.667|1.278|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.278|0.667|0.6307
71012407|NCT03026556|141531858|OTHER||Hazard Ratio (HR)|1.054||||0.8777|TWO_SIDED|95.0|0.54|2.055|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.055|0.540|0.8777
71012408|NCT03026556|141531859|OTHER||Hazard Ratio (HR)|0.223||||0.0023|TWO_SIDED|95.0|0.085|0.585|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||0.585|0.085|0.0023
71012409|NCT03026556|141531860|OTHER||Hazard Ratio (HR)|0.654||||0.0406|TWO_SIDED|95.0|0.435|0.982|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||0.982|0.435|0.0406
71012410|NCT03026556|141531860|OTHER||Hazard Ratio (HR)|1.11||||0.8124|TWO_SIDED|95.0|0.469|2.63|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.630|0.469|0.8124
71012411|NCT03026556|141531861|OTHER||Hazard Ratio (HR)|0.856||||0.0901|TWO_SIDED|95.0|0.716|1.025|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.025|0.716|0.0901
71012412|NCT03026556|141531861|OTHER||Hazard Ratio (HR)|1.431||||0.0616|TWO_SIDED|95.0|0.983|2.083|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.083|0.983|0.0616
71012413|NCT03026556|141531862|OTHER||Hazard Ratio (HR)|0.887||||0.2073|TWO_SIDED|95.0|0.736|1.069|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.069|0.736|0.2073
71012414|NCT03026556|141531862|OTHER||Hazard Ratio (HR)|1.504||||0.0417|TWO_SIDED|95.0|1.015|2.228|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.228|1.015|0.0417
71047392|NCT00922272|141603779|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.8||||0.1072|TWO_SIDED|95.0|-0.6|6.2|||ANCOVA|||||6.2|-0.6|0.1072
71047393|NCT00922272|141603780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.366||95.0|||||t-test, 2 sided|||||||0.3660
71047394|NCT00922272|141603781|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.4347|TWO_SIDED|95.0|-5.0|2.2|||ANCOVA|||||2.2|-5.0|0.4347
71012415|NCT03026556|141531864|OTHER||Hazard Ratio (HR)|0.709||||0.2663|TWO_SIDED|95.0|0.387|1.299|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.299|0.387|0.2663
71012416|NCT03026556|141531864|OTHER||Hazard Ratio (HR)|0.864||||0.8112|TWO_SIDED|95.0|0.261|2.863|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.863|0.261|0.8112
71012417|NCT03026556|141531865|OTHER||Hazard Ratio (HR)|0.766||||0.1227|TWO_SIDED|95.0|0.546|1.075|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.075|0.546|0.1227
71012418|NCT03026556|141531865|OTHER||Hazard Ratio (HR)|1.138||||0.7115|TWO_SIDED|95.0|0.573|2.26|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.260|0.573|0.7115
71012419|NCT03026556|141531866|OTHER||Hazard Ratio (HR)|0.923||||0.4727|TWO_SIDED|95.0|0.741|1.149|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.149|0.741|0.4727
71012420|NCT03026556|141531866|OTHER||Hazard Ratio (HR)|1.721||||0.0275|TWO_SIDED|95.0|1.062|2.79|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.790|1.062|0.0275
71012421|NCT03026556|141531867|OTHER||Hazard Ratio (HR)|1.346||||0.2309|TWO_SIDED|95.0|0.828|2.189|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.189|0.828|0.2309
71047395|NCT00922272|141603782|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4312||95.0|||||t-test, 2 sided|||||||0.4312
71012422|NCT03026556|141531867|OTHER||Hazard Ratio (HR)|1.557||||0.3333|TWO_SIDED|95.0|0.635|3.821|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||3.821|0.635|0.3333
71012423|NCT03026556|141531868|OTHER||Hazard Ratio (HR)|1.008||||0.9359|TWO_SIDED|95.0|0.829|1.226|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.226|0.829|0.9359
71012424|NCT03026556|141531868|OTHER||Hazard Ratio (HR)|1.024||||0.8947|TWO_SIDED|95.0|0.716|1.465|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.465|0.716|0.8947
71047396|NCT00922272|141603783|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5||||0.0874|TWO_SIDED|95.0|-5.4|0.4|||ANCOVA|||||0.4|-5.4|0.0874
71047397|NCT00922272|141603784|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Total Skills||||<0.0001
71047398|NCT00922272|141603784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0|||||t-test, 2 sided|||Communication Skills||||0.0002
71047399|NCT00922272|141603784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0028||95.0|||||t-test, 2 sided|||Financial Skills||||0.0028
71047400|NCT00922272|141603785|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.4637|TWO_SIDED|95.0|-5.3|2.4|||ANCOVA|||Total Skills||2.4|-5.3|0.4637
71012425|NCT01294319|141531869|SUPERIORITY|||||||0.4872|||||||Fisher Exact|||||||0.4872
71012426|NCT01294319|141531870|SUPERIORITY|||||||0.2786|||||||t-test, 2 sided|||||||0.2786
71012427|NCT02924129|141531871|NON_INFERIORITY|non-inferiority margin (δ) of 10%|||||<|0.001||||||Significance threshold (α) of 0.05|normal approximation to the binomial|||||||<0.001
71012428|NCT02924129|141531872|NON_INFERIORITY|non-inferiority margin (δ) of 10%|Mean Difference (Final Values)|9.0|||<|0.001|TWO_SIDED|95.0|-2.4|20.4||significance threshold (α) of 0.05|t-test, 2 sided|||||20.4|-2.4|<0.001
71012429|NCT02924129|141531873|NON_INFERIORITY|non-inferiority margin (δ) of 10%|Mean Difference (Final Values)|14.6|||<|0.001|TWO_SIDED|95.0|2.9|26.3||significance threshold (α) of 0.05|t-test, 2 sided|||||26.3|2.9|<0.001
71012430|NCT02924129|141531874|NON_INFERIORITY|non-inferiority margin (δ) of 10%||||||0.002||||||significance threshold (α) of 0.05|normal approximation to the binomial|||||||0.002
71012431|NCT02924129|141531875|NON_INFERIORITY|non-inferiority margin (δ) of 10%|||||<|0.001||||||significance threshold (α) of 0.05|normal approximation to the binomial|||||||<0.001
71012432|NCT02924129|141531876|NON_INFERIORITY|non-inferiority margin (δ) of 10%|||||<|0.001||||||significance threshold (α) of 0.05|normal approximation to the binomial|||||||<0.001
71012433|NCT02924129|141531877|NON_INFERIORITY|non-inferiority margin (δ) of 10%|Mean Difference (Final Values)|10.7|||<|0.001|TWO_SIDED|95.0|-1.8|23.3||significance threshold (α) of 0.05|t-test, 2 sided|||||23.3|-1.8|<0.001
71012434|NCT02924129|141531878|NON_INFERIORITY|non-inferiority margin (δ) of 10%|Mean Difference (Final Values)|15.4|||<|0.001|TWO_SIDED|95.0|2.5|28.3||significance threshold (α) of 0.05|t-test, 2 sided|||||28.3|2.5|<0.001
71012435|NCT02924129|141531879|NON_INFERIORITY|non-inferiority margin (δ) of 10%|||||<|0.001|||||||normal approximation to the binomial|||||||<0.001
71012436|NCT02924129|141531880|NON_INFERIORITY|non-inferiority margin (δ) of 10%|||||<|0.001||||||significance threshold (α) of 0.05|normal approximation to the binomial|||||||<0.001
71012437|NCT01000311|141531902|SUPERIORITY_OR_OTHER||Lower limit of 95% confidence interval|83.0|||||TWO_SIDED|95.0|83.0|93.0||||||The null hypothesis associated with the primary objective was that the immune response was considered sufficient if the lower limit of the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8, at one month after 4th dose was greater than 80% for the serogroup A.||93|83|
71012438|NCT01000311|141531902|SUPERIORITY_OR_OTHER||Lower limit of 95% confidence interval|90.0|||||TWO_SIDED|95.0|90.0|98.0||||||The null hypothesis associated with the primary objective was that the immune response was considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:8, at one month after 4th dose was greater than 85% for the serogroup C.||98|90|
71012439|NCT01000311|141531902|SUPERIORITY_OR_OTHER||Lower limit of 95% confidence interval|93.0|||||TWO_SIDED|95.0|93.0|99.0||||||The null hypothesis associated with the primary objective was that the immune response was considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:8, at one month after 4th dose was greater than 85% for the serogroup W.||99|93|
71012440|NCT01000311|141531902|SUPERIORITY_OR_OTHER||Lowe limit of 95% confidence interval|92.0|||||TWO_SIDED|95.0|92.0|99.0||||||The null hypothesis associated with the primary objective was that the immune response was considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:8, at one month after 4th dose was greater than 85% for the serogroup Y.||99|92|
71012441|NCT01000311|141531906|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to diphtheria toxin, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|0.0|||||TWO_SIDED|95.0|-2.9|2.6|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to diphtheria toxin, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP vaccine is given alone||2.6|-2.9|
71012442|NCT01000311|141531906|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to tetanus toxin, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|0.0|||||TWO_SIDED|95.0|-3.3|3.9|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to tetanus toxin, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP vaccine is given alone||3.9|-3.3|
71012443|NCT01000311|141531906|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pertussis toxin (PT), when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-4.0|||||TWO_SIDED|95.0|-12.1|4.3|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pertussis toxin (PT), when DTaP vaccine is given, compared with MenACWY-CRM compared with when DTaP vaccine is given alone||4.3|-12.1|
71012444|NCT01000311|141531906|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pertussis (FHA antigen), when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|4.0|||||TWO_SIDED|95.0|-5.1|13.6|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pertussis FHA antigen, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP vaccine is given alone||13.6|-5.1|
71012445|NCT01000311|141531906|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pertussis pertactin antigen, when DTaP vaccine is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|0.0|||||TWO_SIDED|95.0|-8.8|9.1|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pertussis pertactin antigen, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP is given alone.||9.1|-8.8|
71047401|NCT00922272|141603785|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.6137|TWO_SIDED|95.0|-4.1|2.4|||ANCOVA|||Communication Skills||2.4|-4.1|0.6137
71047402|NCT00922272|141603785|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.3482|TWO_SIDED|95.0|-3.5|1.3|||ANCOVA|||Financial Skills||1.3|-3.5|0.3482
71047403|NCT00922272|141603786|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0174||95.0|||||t-test, 2 sided|||Global Executive Composite||||0.0174
71012446|NCT01000311|141531906|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pertussis FIM antigen, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-2.0|||||TWO_SIDED|95.0|-10.6|6.8|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pertussis FIM antigen, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP vaccine is given alone||6.8|-10.6|
71012447|NCT01000311|141531906|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to hepatitis B, when given concomitantly with MenACWY-CRM, was considered non-inferior to that of hepatitis B vaccine given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|0.0|||||TWO_SIDED|95.0|-5.2|4.5|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to hepatitis B antigen, when hepatitis B vaccine is given with MenACWY-CRM compared with when hepatitis B vaccine is given alone.||4.5|-5.2|
71012448|NCT01000311|141531906|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to Hib vaccine, when given concomitantly with MenACWY-CRM, was considered non-inferior to that of Hib vaccine given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|5.0|||||TWO_SIDED|95.0|0.0|11.2|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to Hib antigen, when Hib vaccine is given with MenACWY-CRM compared with when Hib vaccine is given alone.||11.2|0|
71012449|NCT01000311|141531906|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to polio antigen (Type 1), when IPV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of IPV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -5%.|Group difference|1.0|||||TWO_SIDED|95.0|-3.1|5.4|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to polio antigen (Type 1), when IPV routine is given with MenACWY-CRM, compared with when IPV is given alone||5.4|-3.1|
71012450|NCT01000311|141531906|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to polio antigen (Type 2), when IPV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of IPV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -5%.|Group difference|1.0|||||TWO_SIDED|95.0|-1.4|3.0|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to polio antigen (Type 2), when IPV routine is given with MenACWY-CRM, compared with when IPV is given alone||3|-1.4|
71012451|NCT01000311|141531906|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to polio antigen (Type 3), when IPV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of IPV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -5%.|Group difference|-1.0|||||TWO_SIDED|95.0|-3.3|1.7|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to polio antigen (Type 3), when IPV routine is given with MenACWY-CRM, compared with when IPV is given alone||1.7|-3.3|
71012452|NCT01000311|141531906|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 4 antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|1.0|||||TWO_SIDED|95.0|-1.9|4.6|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 4 antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||4.6|-1.9|
71012453|NCT01000311|141531906|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 6B antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-4.0|||||TWO_SIDED|95.0|-10.3|3.2|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 6B antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||3.2|-10.3|
71012454|NCT01000311|141531906|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 9V antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-3.0|||||TWO_SIDED|95.0|-8.7|2.3|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 9V antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||2.3|-8.7|
71012455|NCT01000311|141531906|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 14 antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|0.0|||||TWO_SIDED|95.0|-2.8|3.0|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 14 antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||3.0|-2.8|
71047404|NCT00922272|141603786|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0461||95.0|||||t-test, 2 sided|||Behavioral Recognition Index||||0.0461
71047405|NCT00922272|141603786|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0146||95.0|||||t-test, 2 sided|||Metacognition Index||||0.0146
71047406|NCT00922272|141603787|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.7418|TWO_SIDED|95.0|-3.8|2.7|||ANCOVA|||Global Executive Composite||2.7|-3.8|0.7418
71047407|NCT00922272|141603787|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8||||0.6429|TWO_SIDED|95.0|-2.6|4.1|||ANCOVA|||Behavioral Recognition Index||4.1|-2.6|0.6429
71047408|NCT00922272|141603787|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.4364|TWO_SIDED|95.0|-4.8|2.1|||ANCOVA|||Metacognition Index||2.1|-4.8|0.4364
71047409|NCT02588950|141603798|SUPERIORITY||Geometric LSMean Ratio|1.46|||||TWO_SIDED|90.0|1.08|1.97|||Mixed Models Analysis|||||1.97|1.08|
71047410|NCT02588950|141603802|SUPERIORITY||Geometric LSMean Ratio|0.885|||||TWO_SIDED|90.0|0.761|1.03|||Mixed Models Analysis|||||1.03|0.761|
71047411|NCT02588950|141603803|SUPERIORITY||Median Difference (Final Values)|0.9|||||TWO_SIDED|90.0|-1.6|2.6||||||||2.60|-1.60|
71012456|NCT01000311|141531906|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 18C antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-3.0|||||TWO_SIDED|95.0|-7.3|1.6|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 18C antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||1.6|-7.3|
71047412|NCT02072824|141603816|SUPERIORITY||Least Square Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.153||0.4606|TWO_SIDED|95.0|-0.19|0.42|||ANCOVA|||Linear model with log transformed baseline seizure rate as continuous covariate and treatment, age stratum, and geographical region as fixed factor effects.||0.42|-0.19|0.4606
71047413|NCT02072824|141603816|SUPERIORITY||Least Square Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.185||0.0223|TWO_SIDED|95.0|-0.8|-0.06|||ANCOVA|||Linear model with log transformed baseline seizure rate as continuous covariate and treatment, age stratum, and geographical region as fixed factor effects.||-0.06|-0.80|0.0223
71047414|NCT02072824|141603817|SUPERIORITY||Odds Ratio (OR)|0.625||||0.2418|TWO_SIDED|95.0|0.284|1.373|||Regression, Logistic|||The dichotomized responder variable was analyzed using a logistic regression model via maximum likelihood estimation with treatment group, age stratum, and geographical region as a fixed effect covariates.||1.373|0.284|0.2418
71047415|NCT02072824|141603817|SUPERIORITY||Odds Ratio (OR)|1.622||||0.305|TWO_SIDED|95.0|0.644|4.086|||Regression, Logistic|||The dichotomized responder variable was analyzed using a logistic regression model via maximum likelihood estimation with treatment group, age stratum, and geographical region as a fixed effect covariates.||4.086|0.644|0.3050
71047416|NCT00841906|141603838|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
71047417|NCT00903448|141603842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001|TWO_SIDED|95.0||||The least squares treatment means, i.e. adjusted treatment means, and standard errors were computed from the analysis of variance models.|Mixed Models Analysis|||This study enrolled 40 subjects in order to complete a target of at least 30 evaluable subjects. For the purpose of determination of sample size, it was assumed that at least 30 subjects would have complete data for all 3 treatment periods. Assuming the true mean difference in % time that gastric pH \> 4.0 between Prilosec OTC and Prevacid was at least 6.5, it was estimated that there would be at least 80% power to detect a treatment difference in 2-sided testing at the 5% significance level.||||< 0.0001
71047418|NCT00912093|141603845|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Peto-Peto Wilcoxon|||||||<0.001
71047419|NCT00912093|141603846|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Peto-Peto Wilcoxon|||||||<0.001
71047420|NCT00912093|141603847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|||||||Peto Peto Wilcoxon|||||||0.012
71047421|NCT00912093|141603848|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Peto-Peto Wilcoxon|||||||<0.001
71047422|NCT00912093|141603849|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Peto-Peto Wilcoxon|||||||<0.001
71047423|NCT04397445|141603863|SUPERIORITY|||||||0.54||||||A 1-sided lower P value \<.05 was considered significant for ranitidine vs. placebo as the aim was to evaluate if ranitidine increased NDMA exposure. Comparisons were performed separately with each diet without adjustment for multiplicity.|Wilcoxon (Mann-Whitney)|||A Wilcoxon signed-rank test was used for analyses, per the statistical analysis plan, as NDMA urine data were not normally distributed|The median of the paired differences (interquartile range) between ranitidine and placebo is 0 (-6.9 to 0) ng. The median of the paired differences is calculated by first determining the difference between the two treatments for each individual participant and then determining the median of those values. The Wilcoxon signed-rank test that was used for NDMA analyses is also based on first determining the difference between the treatment groups for each individual participant.|||0.54
71047424|NCT04397445|141603863|SUPERIORITY|||||||0.71||||||A 1-sided lower P value \<.05 was considered significant for ranitidine vs. placebo as the aim was to evaluate if ranitidine increased NDMA exposure. Comparisons were performed separately with each diet without adjustment for multiplicity.|Wilcoxon (Mann-Whitney)|||A Wilcoxon signed-rank test was used for analyses, per the statistical analysis plan, as NDMA urine data were not normally distributed|The median of the paired differences (interquartile range) between ranitidine and placebo is -1.1 (-9.1 to 11.5) ng. The median of the paired differences is calculated by first determining the difference between the two treatments for each individual participant and then determining the median of those values. The Wilcoxon signed-rank test that was used for NDMA analyses is also based on first determining the difference between the treatment groups for each individual participant.|||0.71
71047425|NCT04397445|141603864|SUPERIORITY|||||||0.005||||||Exploratory analyses on the effect of diet used a 1-sided lower P value \<.05 for NDMA as the cured-meats diet was designed to have higher NDMA.|Wilcoxon (Mann-Whitney)|||A Wilcoxon signed-rank test was used for analyses, per the statistical analysis plan, as NDMA urine data were not normally distributed|The median of the paired differences (interquartile range) between the cured-meats diet and noncured-meats diet is 9.3 (3.8 to 25.0) ng. The median of the paired differences is calculated by first determining the difference between the two treatments for each individual participant and then determining the median of those values. The Wilcoxon signed-rank test that was used for NDMA analyses is also based on first determining the difference between the treatment groups for each individual participant.|||0.005
71047426|NCT04397445|141603864|SUPERIORITY|||||||0.007||||||Exploratory analyses on the effect of diet used a 1-sided lower P value \<.05 for NDMA as the cured-meats diet was designed to have higher NDMA|Wilcoxon (Mann-Whitney)|||A Wilcoxon signed-rank test was used for analyses, per the statistical analysis plan, as NDMA urine data were not normally distributed|The median of the paired differences (interquartile range) between the cured-meats diet and noncured-meats diet is 6.4 (0 to 23.4) ng. The median of the paired differences is calculated by first determining the difference between the two treatments for each individual participant and then determining the median of those values. The Wilcoxon signed-rank test that was used for NDMA analyses is also based on first determining the difference between the treatment groups for each individual participant.|||0.007
71012457|NCT01000311|141531906|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 19F antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|3.0|||||TWO_SIDED|95.0|1.3|7.1|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 19F antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||7.1|1.3|
71012458|NCT01000311|141531906|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 23F antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-5.0|||||TWO_SIDED|95.0|-11.4|0.5|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 23F antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||0.5|-11.4|
71012459|NCT01000311|141531907|NON_INFERIORITY_OR_EQUIVALENCE|The immune response measured as GMC of antibodies to pertussis toxin (PT), when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Routine Vaccines group divided by GMC of Routine Vaccines group) was greater than 0.67.|GMCs ratio|1.02|||||TWO_SIDED|95.0|0.81|1.28|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pertussis toxin (PT), when DTaP is given with MenACWY-CRM compared with when DTap is given alone||1.28|0.81|
71012460|NCT01000311|141531907|NON_INFERIORITY_OR_EQUIVALENCE|The immune response measured as GMC of antibodies to pertussis FHA antigen, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Routine Vaccines group divided by GMC of Routine Vaccines group) was greater than 0.67.|GMCs ratio|1.04|||||TWO_SIDED|95.0|0.9|1.19|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pertussis FHA antigen, when DTaP is given with MenACWY-CRM compared with when DTaP is given alone||1.19|0.9|
71047427|NCT04397445|141603865|OTHER||Geometric Mean Ratio|0.94||||0.92|TWO_SIDED|90.0|0.87|1.01||A 1-sided lower P value \<.05 was considered significant for the exploratory analyses of ranitidine vs. placebo because the study aim was to evaluate if ranitidine increased DMA exposure.|Mixed Models Analysis||This compares the results from ranitidine (numerator) with placebo (denominator).|As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence||1.01|0.87|0.92
71047428|NCT04397445|141603865|OTHER||Geometric Mean Ratio|0.95||||0.74|TWO_SIDED|90.0|0.81|1.1||A 1-sided lower P value \<.05 was considered significant for the exploratory analyses of ranitidine vs. placebo because the study aim was to evaluate if ranitidine increased DMA exposure.|Mixed Models Analysis||This compares the results from ranitidine (numerator) with placebo (denominator).|As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence||1.10|0.81|0.74
71047429|NCT04397445|141603865|OTHER||Geometric Mean Ratio|1.05||||0.52|TWO_SIDED|95.0|0.9|1.23||A 2-sided P value \<.05 was used for DMA as the diet was not expected to affect these outcomes|Mixed Models Analysis||This compares the results from the cured-meats diet (numerator) with the noncured-meats diet (denominator)|As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence.||1.23|0.90|0.52
71047430|NCT04397445|141603865|OTHER||Geometric Mean Ratio|1.05||||0.42|TWO_SIDED|95.0|0.93|1.19||A 2-sided P value \<.05 was used for DMA as the diet was not expected to affect these outcomes|Mixed Models Analysis||This compares the results from the cured-meats diet (numerator) with the noncured-meats diet (denominator)|As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence.||1.19|0.93|0.42
71047431|NCT04397445|141603866|OTHER||Geometric Mean Ratio|0.81||||0.001|TWO_SIDED|95.0|0.72|0.91||Exploratory analyses on the effect of diet used a 2-sided P value \<.05 for ranitidine as the diet was not expected to affect these outcomes|Mixed Models Analysis|||As ranitidine data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence|This compares the results from the cured-meats diet (numerator) with the noncured-meats diet (denominator)|0.91|0.72|0.001
71047432|NCT04397445|141603868|OTHER||Geometric Mean Ratio|1.0||||0.46|TWO_SIDED|90.0|0.91|1.11||A 1-sided lower P value \<.05 was considered significant for the exploratory analyses of ranitidine vs. placebo because the study aim was to evaluate if ranitidine increased DMA exposure.|Mixed Models Analysis||This compares the results from ranitidine (numerator) with placebo (denominator)|As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence||1.11|0.91|0.46
71047433|NCT04397445|141603868|OTHER||Geometric Mean Ratio|1.0||||0.49|TWO_SIDED|90.0|0.8|1.25||A 1-sided lower P value \<.05 was considered significant for the exploratory analyses of ranitidine vs. placebo because the study aim was to evaluate if ranitidine increased DMA exposure.|Mixed Models Analysis|||As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence|This compares the results from ranitidine (numerator) with placebo (denominator)|1.25|0.80|0.49
71047434|NCT04397445|141603868|OTHER||Geometric Mean Ratio|0.8||||0.02|TWO_SIDED|95.0|0.67|0.95||A 2-sided P value \<.05 was used for DMA as the diet was not expected to affect these outcomes|Mixed Models Analysis||This compares the results from the cured-meats diet (numerator) with the noncured-meats diet (denominator)|As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence.||0.95|0.67|0.02
71103867|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2534|STANDARD_ERROR_OF_MEAN|0.17208||0.15|TWO_SIDED|95.0|-0.6032|0.0963|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Paracingulte gyrus/BA32: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0963|-0.6032|0.150
71103868|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2821|STANDARD_ERROR_OF_MEAN|0.19038||0.148|TWO_SIDED|95.0|-0.669|0.1048|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Paracingulte gyrus/BA3: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1048|-0.6690|0.148
71103869|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.048|STANDARD_ERROR_OF_MEAN|0.20543||0.817|TWO_SIDED|95.0|-0.4655|0.3695|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Paracingulte gyrus/BA32: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3695|-0.4655|0.817
71103870|NCT01892189|141715122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3395|STANDARD_ERROR_OF_MEAN|0.19513||0.091|TWO_SIDED|95.0|-0.7361|0.057|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Paracingulte gyrus/BA32: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0570|-0.7361|0.091
71103871|NCT01139515|141715141|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|98.7|||||TWO_SIDED|90.0|92.17|105.7||||||Natural log transformed, dose-normalized AUC\[0- ∞\] of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||105.70|92.17|
71103872|NCT01139515|141715141|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|109.48|||||TWO_SIDED|90.0|102.23|117.24||||||Natural log transformed, dose-normalized AUC\[0- ∞\] of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||117.24|102.23|
71012461|NCT01000311|141531907|NON_INFERIORITY_OR_EQUIVALENCE|The immune response measured as GMC of antibodies to pertussis pertactin antigen, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Routine Vaccines group divided by GMC of Routine Vaccines group) was greater than 0.67.|GMCs ratio|1.04|||||TWO_SIDED|95.0|0.84|1.28|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pertussis pertactin antigen, when DTaP is given with MenACWY-CRM compared with when DTaP is given alone||1.28|0.84|
71012462|NCT01000311|141531907|NON_INFERIORITY_OR_EQUIVALENCE|The immune response measured as GMC of antibodies to pertussis FIM antigen, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Routine Vaccines group divided by GMC of Routine Vaccines group) was greater than 0.67.|GMCs ratio|1.09|||||TWO_SIDED|95.0|0.88|1.35|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pertussis FIM antigen, when DTaP is given with MenACWY-CRM compared with when DTaP is given alone||1.35|0.88|
71012463|NCT01000311|141531908|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 4 antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.98|||||TWO_SIDED|95.0|0.8|1.19|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 4 antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||1.19|0.8|
71012464|NCT01000311|141531908|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 6B antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.76|||||TWO_SIDED|95.0|0.62|0.93|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 6B antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||0.93|0.62|
71012465|NCT01000311|141531908|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 9V antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.87|||||TWO_SIDED|95.0|0.72|1.06|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 9V antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||1.06|0.72|
71012466|NCT01000311|141531908|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 14 antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|1.04|||||TWO_SIDED|95.0|0.84|1.28|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 14 antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||1.28|0.84|
71103873|NCT01139515|141715141|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|109.93|||||TWO_SIDED|90.0|102.65|117.72||||||Natural log transformed, dose-normalized AUC\[0- ∞\] of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||117.72|102.65|
71047435|NCT04397445|141603868|OTHER||Geometric Mean Ratio|0.8||||0.03|TWO_SIDED|95.0|0.65|0.98||A 2-sided P value \<.05 was used for DMA as the diet was not expected to affect these outcomes|Mixed Models Analysis|||As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence|This compares the results from the cured-meats diet (numerator) with the noncured-meats diet (denominator)|0.98|0.65|0.03
71047436|NCT04397445|141603869|OTHER||Geometric Mean Ratio|0.77||||0.002|TWO_SIDED|95.0|0.66|0.89||Exploratory analyses on the effect of diet used a 2-sided P value \<.05 for ranitidine as the diet was not expected to affect these outcomes|Mixed Models Analysis||This compares the results from the cured-meats diet (numerator) with the noncured-meats diet (denominator).|As ranitidine data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence||0.89|0.66|0.002
71047437|NCT00270257|141603881|SUPERIORITY_OR_OTHER_LEGACY||Incident rate per 100 person-years|1.5|||||TWO_SIDED|95.0|0.7|2.8||||||||2.8|0.7|
71047438|NCT00270257|141603881|SUPERIORITY_OR_OTHER_LEGACY||Incident rate per 100 person-years|2.2|||||TWO_SIDED|95.0|1.2|3.7||||||||3.7|1.2|
71103874|NCT01139515|141715142|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric means ratio|99.41|||||TWO_SIDED|90.0|92.97|106.31||||||Natural log transformed, dose-normalized AUClast of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||106.31|92.97|
71103875|NCT01139515|141715142|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|110.52|||||TWO_SIDED|90.0|103.36|118.18||||||Natural log transformed, dose-normalized AUClast of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||118.18|103.36|
71103876|NCT01139515|141715142|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|110.44|||||TWO_SIDED|90.0|103.28|118.09||||||Natural log transformed, dose-normalized AUClast of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||118.09|103.28|
71012467|NCT01000311|141531908|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 18C antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.99|||||TWO_SIDED|95.0|0.82|1.2|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 18C antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||1.2|0.82|
71012468|NCT01000311|141531908|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 19F antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.89|||||TWO_SIDED|95.0|0.73|1.07|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 19F antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||1.07|0.73|
71012469|NCT01000311|141531908|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 23F antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.84|||||TWO_SIDED|95.0|0.68|1.04|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 23F antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||1.04|0.68|
71012470|NCT02780869|141531914|NON_INFERIORITY|The primary endpoint was designed to establish comparable efficacy based upon a non-inferiority margin of 10% for the difference in the probability of TTH within 6 minutes comparing HEMOBLAST™ to G+T (HEMOBLAST™- G+T). Letting θ denote the true difference in the probability of hemostasis at 6 minutes between HEMOBLAST™ to G+T, the trial will test the null hypothesis H0: θ ≤ -0.10 vs. the alternative hypothesis HA : θ \> -0.10 using a one-sided level 0.025 test.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified adjustments for surgery type were made using the Cochran-Mantel-Haenszel weighting.||||||<0.0001
71012471|NCT02780869|141531914|SUPERIORITY|||||||0.0001||||||Adjustment for mulitple comparisons were made when assessing secondary endpoints using a fixed sequence closed testing procedure to control the family-wise type I error rate at 0.05|Cochran-Mantel-Haenszel|||A secondary endpoint of superiority of HEMOBLAST relative to G+T for success at achieving hemostasis within 6 minutes was evaluated.||||0.0001
71012472|NCT02780869|141531915|SUPERIORITY||||||<|0.0001||||||Adjustment for mulitple comparisons were made when assessing secondary endpoints using a fixed sequence closed testing procedure to control the family-wise type I error rate at 0.05|Regression, Linear|||The difference in mean preparation time was tested using a linear regression model with stratified adjustment for surgery type.||||<0.0001
71047439|NCT00270257|141603881|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.694||||0.3769|TWO_SIDED|95.0|0.308|1.562|||Regression, Cox|||||1.562|0.308|0.3769
71047440|NCT00270257|141603882|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.844||||0.4325|TWO_SIDED|95.0|0.553|1.289||P value applies for the comparison at visit 104.|Regression, Logistic|adjusted for site||||1.289|0.553|0.4325
71047441|NCT00270257|141603883|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.8||||0.2749|TWO_SIDED|95.0|0.536|1.194||P value applies for the comparison at visit 104 only.|Regression, Logistic|||||1.194|0.536|0.2749
71012473|NCT02780869|141531916|NON_INFERIORITY|The difference in the probability of hemostasis within 3 minutes was tested using a logistic regression model with stratified adjustment for surgery type.|||||<|0.0001||||||Adjustment for multiple comparisons when assessing secondary endpoints was performed using a fixed sequence closed testing procedure to control the family-wise type I error rate at 0.05.|Regression, Logistic|||||||<0.0001
71012474|NCT02780869|141531916|SUPERIORITY|The difference in the probability of hemostasis within 3 minutes was tested using a logistic regression model with stratified adjustment for surgery type.||||||0.0001||||||Adjustment for multiple comparisons when assessing secondary endpoints was performed using a fixed sequence closed testing procedure to control the family-wise type I error rate at 0.05.|Regression, Logistic|||||||0.0001
71012475|NCT01377194|141531988|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.303||||0.0027|TWO_SIDED|95.0|-5.457|-1.148|||mixed-model for repeated measures|||||-1.148|-5.457|0.0027
71012476|NCT01377194|141531988|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.141||||0.0043|TWO_SIDED|95.0|-5.293|-0.988|||mixed-model for repeated measures|||||-0.988|-5.293|0.0043
71012477|NCT01377194|141531989|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.827||||0.0459|TWO_SIDED|95.0|-3.62|-0.033|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-0.033|-3.620|0.0459
71012478|NCT01377194|141531989|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.72||||0.0028|TWO_SIDED|95.0|-4.494|-0.946|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-0.946|-4.494|0.0028
71012479|NCT02138227|141532002|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71012480|NCT02138227|141532003|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANOVA|F (2, 1574)||||||<0.01
71012481|NCT01224171|141532029|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.0||||0.4332|TWO_SIDED|95.0|-4.5|10.5|||Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|Clinical remission was tested using the Cochran-Mantel-Haenszel (CMH) chi-square test at a 5% significance level with stratification according to concomitant use of oral corticosteroids and concomitant use of immunomodulators (6-mercaptopurine \[6-MP\], azathioprine, or methotrexate) for the TNFα antagonist failure subpopulation.||10.5|-4.5|0.4332
71012482|NCT03737812|141532038|OTHER|a statistical test was not performed|Odds Ratio (OR)|2.23|||||TWO_SIDED|95.0|0.485|10.259||||||Analyzed using a logistic regression model with corresponding baseline value as a covariate and treatment as a main effect. Logistic regression model for EDSS+ includes baseline values for EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant, 9-Hole Peg Test-nondominant, and treatment as a main effect. Subjects with missing values were imputed as non-responders.||10.259|0.485|
71047442|NCT00270257|141603884|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.746||||0.3446|TWO_SIDED|95.0|0.407|1.369||Analysis is done for visit 104|Regression, Logistic|Adjusted for site||||1.369|0.407|0.3446
71047443|NCT00270257|141603885|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.8712||||0.362|TWO_SIDED|95.0|0.6477|1.1718||P value applies for the comparison at visit 104 only. See the estimation comments for the other visits|Generalized linear model|adjusted for site.||||1.1718|0.6477|0.3620
71047444|NCT00270257|141603886|SUPERIORITY_OR_OTHER_LEGACY||Incident rate of 100 person-years|22.0|||||TWO_SIDED|95.0|14.7|31.6|||||29 events over 132 person-years|||31.6|14.7|
71047445|NCT00270257|141603886|SUPERIORITY_OR_OTHER_LEGACY||Incident rate of 100 person-years|4.59|||||TWO_SIDED|95.0|2.0|9.0|||||8 events over 174 person-years|||9.0|2.0|
71047446|NCT00270257|141603887|SUPERIORITY_OR_OTHER_LEGACY||Incident rate of 100 person-years|2.7|||||TWO_SIDED|95.0|1.22|5.08|||||9 events over 336 person-years|||5.08|1.22|
71047447|NCT00270257|141603887|SUPERIORITY_OR_OTHER_LEGACY||Incident rate of 100 person-years|0.0|||||TWO_SIDED|95.0|0.0|10.1|||||0 events over 37 person-years|||10.1|0.00|
71047448|NCT01338649|141603922|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0211|||||||t-test, 2 sided|t-test on two groups of differences||||||0.0211
71047449|NCT00361335|141603939|SUPERIORITY_OR_OTHER|||||||0.051||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups V vs VI at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and \~29-31 percentage response in the Group VI at α = 0.05.||||0.051
71012483|NCT03737812|141532038|OTHER|a statistical test was not performed|Odds Ratio (OR)|3.859|||||TWO_SIDED|95.0|0.899|16.561||||||Analyzed using a logistic regression model with corresponding baseline value as a covariate and treatment as a main effect. Logistic regression model for EDSS+ includes baseline values for EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant, 9-Hole Peg Test-nondominant, and treatment as a main effect. Subjects with missing values were imputed as non-responders.||16.561|0.899|
71012484|NCT04140942|141532057|SUPERIORITY|||||||0.15|||||||Chi-squared|||6-Month Employment||||.15
71012485|NCT04140942|141532057|SUPERIORITY|||||||0.001|||||||Regression, Logistic|||6-Month Employment||||.001
71012486|NCT04140942|141532057|SUPERIORITY|||||||0.87|||||||Chi-squared|||12-Month Employment||||.87
71012487|NCT04140942|141532058|SUPERIORITY|||||||0.04|||||||ANCOVA|Repeated measures.||||||0.04
71012488|NCT04140942|141532059|SUPERIORITY|||||||0.056|||||||Chi-squared|||12-Month Recidivism Analysis||||.056
71012489|NCT04140942|141532059|SUPERIORITY|||||||0.18|||||||Chi-squared|||6-Month Recidivism Analysis||||.18
71012490|NCT00933543|141532094|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.43||||0.0703|TWO_SIDED|95.0|0.65|63.18||Priori threshold for statistical significance was 5%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by center. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||63.18|0.65|0.0703
71047450|NCT00361335|141603939|SUPERIORITY_OR_OTHER|||||||0.073||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups I vs V at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and \~29-31% response in the Group I at α = 0.05.||||0.073
71047451|NCT00361335|141603939|SUPERIORITY_OR_OTHER|||||||0.093||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups III vs V at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and \~29-31 percentage response in the Group III at α = 0.05.||||0.093
71012491|NCT00933543|141532096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.92||||0.2969|TWO_SIDED|95.0|-11.35|3.5||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model, including center and baseline lesion count as a covariates||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||3.50|-11.35|0.2969
71047452|NCT00361335|141603939|SUPERIORITY_OR_OTHER|||||||0.465||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups VII vs V at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and \~29-31 percentage response in the Group VII at α = 0.05.||||0.465
71047453|NCT00361335|141603939|SUPERIORITY_OR_OTHER|||||||0.872||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups II vs V at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and \~29-31 percentage response in the Group II at α = 0.05.||||0.872
71047454|NCT00361335|141603939|SUPERIORITY_OR_OTHER|||||||0.175||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and \~29-31 percentage response in the combined group (I and III) at α = 0.05.||||0.175
71047455|NCT00361335|141603940|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups V vs VI at 0.05 level of significance.||||0.002
71047456|NCT00361335|141603940|SUPERIORITY_OR_OTHER|||||||0.032||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups I vs V at 0.05 level of significance.||||0.032
71047457|NCT00361335|141603940|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups III vs V at 0.05 level of significance.||||<0.001
71047458|NCT00361335|141603940|SUPERIORITY_OR_OTHER|||||||0.795||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups V vs VII at 0.05 level of significance.||||0.795
71047459|NCT00361335|141603940|SUPERIORITY_OR_OTHER|||||||0.844||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups II vs V at 0.05 level of significance.||||0.844
71103877|NCT01139515|141715143|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric means ratio|101.81|||||TWO_SIDED|90.0|85.97|120.58||||||"Natural log transformed, dose-normalized Cmax of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.~The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios."||120.58|85.97|
71103878|NCT01139515|141715143|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|98.57|||||TWO_SIDED|90.0|83.23|116.73||||||"Natural log transformed, dose-normalized Cmax of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.~The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios."||116.73|83.23|
71103879|NCT01139515|141715143|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|107.44|||||TWO_SIDED|90.0|90.72|127.25||||||"Natural log transformed, dose-normalized Cmax of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.~The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios."||127.25|90.72|
71047460|NCT00361335|141603940|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance.||||0.540
71047461|NCT00361335|141603941|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups V vs VI at 0.05 level of significance.||||<0.001
71047462|NCT00361335|141603941|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups I vs V at 0.05 level of significance.||||<0.001
71047463|NCT00361335|141603941|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups III vs V at 0.05 level of significance.||||<0.001
71047464|NCT00361335|141603941|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups V vs VII at 0.05 level of significance.||||0.002
71103880|NCT01358734|141715156|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.789||||0.119|TWO_SIDED|95.0|0.861|3.718|||Log Rank|||||3.718|0.861|0.119
71012492|NCT00933543|141532097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.67||||0.8913|TWO_SIDED|95.0|-9.09|10.43||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model, including center and baseline lesion count as a covariates||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||10.43|-9.09|0.8913
71047465|NCT00361335|141603941|SUPERIORITY_OR_OTHER|||||||0.043||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups II vs V at 0.05 level of significance.||||0.043
71047466|NCT00361335|141603941|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance.||||<0.001
71047467|NCT00361335|141603942|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups V vs VI at 0.05 level of significance.||||<0.001
71047468|NCT00361335|141603942|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups I vs V at 0.05 level of significance.||||<0.001
71012493|NCT04837807|141532120|SUPERIORITY||Mean Difference (Final Values)|22.4|STANDARD_DEVIATION|12.8|<|0.05|TWO_SIDED||||||ANOVA|This was a cross-over study, so there is really 30 subjects per group that was analyzed.||"Each participant in the study was asked to complete the IDEEL work at their baseline, week 1 and week 2 visits. The IDEEL work is graded on a scale to 100 with higher numbers being deemed as better scores thus representing more comfort than previous weeks."||||<0.05
71012494|NCT04837807|141532122|SUPERIORITY|OSDI scores were obtained across all three visits, baseline, week 1 and week 2. Lower OSDI scores indicate better eye health.|Mean Difference (Final Values)|10.5|STANDARD_DEVIATION|7.3|<|0.05|TWO_SIDED||||||ANOVA|This was a cross-over study, so there is really 30 subjects per group that was analyzed.||||||<0.05
71012495|NCT00612456|141532126|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means using the LOCF dataset.|Mean Difference (Final Values)|5.83|STANDARD_ERROR_OF_MEAN|18.332||0.6241|TWO_SIDED|95.0|-31.05|42.71||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||Comparison between Baseline value and Day 29 value.||42.71|-31.05|0.6241
71012496|NCT00612456|141532126|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means using the LOCF dataset.|Mean Difference (Final Values)|11.87|STANDARD_ERROR_OF_MEAN|19.081||0.7315|TWO_SIDED|95.0|-26.52|50.26||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||Comparison between Baseline value and Day 29 value.||50.26|-26.52|0.7315
71012497|NCT00612456|141532126|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means using the OC dataset.|Mean Difference (Final Values)|5.76|STANDARD_ERROR_OF_MEAN|18.566||0.6212|TWO_SIDED|95.0|-31.65|43.18||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||Comparison between Baseline value and Day 29 value.||43.18|-31.65|0.6212
71012498|NCT00612456|141532126|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means using the OC dataset.|Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|20.662||0.5987|TWO_SIDED|95.0|-36.44|46.84||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||Comparison between Baseline value and Day 29 value.||46.84|-36.44|0.5987
71012499|NCT00612456|141532126|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Median Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|18.114||0.482|TWO_SIDED|95.0|-37.28|35.64||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||LOCF Data excluding potential one outlier participant. Comparison between Baseline value and Day 29 value.||35.64|-37.28|0.4820
71012500|NCT00612456|141532126|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|19.9|STANDARD_ERROR_OF_MEAN|18.496||0.8562|TWO_SIDED|95.0|-17.33|57.13||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||LOCF Data excluding potential one outlier participant. Comparison between Baseline value and Day 29 value.||57.13|-17.33|0.8562
71012501|NCT00612456|141532126|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|18.3||0.488|TWO_SIDED|95.0|-37.46|36.35||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||OC Data excluding potential one outlier participant. Comparison between Baseline value and Day 29 value.||36.35|-37.46|0.4880
71047469|NCT00361335|141603942|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups III vs V at 0.05 level of significance.||||<0.001
71047470|NCT00361335|141603942|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups V vs VII at 0.05 level of significance.||||<0.001
71047471|NCT00361335|141603942|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups II vs V at 0.05 level of significance.||||0.003
71047472|NCT00361335|141603942|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|No adjustments were made to control for multiplicity||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance.||||0.001
71047473|NCT00361335|141603943|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups V vs VI at 0.05 level of significance.||||0.005
71012502|NCT00612456|141532126|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|13.97|STANDARD_ERROR_OF_MEAN|20.008||0.7556|TWO_SIDED|95.0|-26.38|54.32||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||OC Data excluding potential one outlier participant. Comparison between Baseline value and Day 29 value.||54.32|-26.38|0.7556
71012503|NCT00612456|141532133|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on efficacy population.|Mean Difference (Final Values)|4.32|STANDARD_ERROR_OF_MEAN|1.29||0.0015|TWO_SIDED|95.0|1.74|6.91|||ANCOVA|||Comparison between Baseline value and Day 29 value.||6.91|1.74|0.0015
71047474|NCT00361335|141603943|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups I vs V at 0.05 level of significance.||||0.014
71012504|NCT00612456|141532133|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on efficacy population.|Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|1.403||0.5921|TWO_SIDED|95.0|-2.05|3.57|||ANCOVA|||Comparison between Baseline value and Day 29 value.||3.57|-2.05|0.5921
71103881|NCT01358734|141715156|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.659||||0.014|TWO_SIDED|95.0|1.214|5.822|||Log Rank|||||5.822|1.214|0.014
71103882|NCT01358734|141715156|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.367||||0.356|TWO_SIDED|95.0|0.704|2.653|||Log Rank|||||2.653|0.704|0.356
71103883|NCT03322566|141715189|SUPERIORITY||Difference in Percentages|-18.5||||0.9948|TWO_SIDED|95.0|-32.0|-4.3||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen method||Stratified by PD-L1 TPS ( \<50% vs. \>=50% ) and predominant tumor histology (squamous vs non-squamous);because of small sample size, the strata 'TPS \>= 50 percent Non-squamous' and 'TPS \>= 50% Squamous' were combined into one stratum.|||-4.3|-32.0|0.9948
71012505|NCT00612456|141532133|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on efficacy population.|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|1.988||0.9646|TWO_SIDED|95.0|-3.89|4.07|||ANCOVA|||Comparison between Baseline value and Day 29 value.||4.07|-3.89|0.9646
71012506|NCT00612456|141532133|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on participants with a 'YES' for RCA NONE field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|4.75||||0.0003|TWO_SIDED|95.0|2.32|7.19|||ANCOVA|||Comparison between Baseline value and Day 29 value.||7.19|2.32|0.0003
71012507|NCT00612456|141532133|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on participants with a 'YES' for RCA NONE field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|1.64|STANDARD_ERROR_OF_MEAN|1.326||0.2208|TWO_SIDED|95.0|-1.02|4.3|||ANCOVA|||Comparison between Baseline value and Day 29 value.||4.30|-1.02|0.2208
71012508|NCT00612456|141532133|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on participants with a 'YES' for RCA NONE field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|1.927||0.9847|TWO_SIDED|95.0|-3.9|3.83|||ANCOVA|||Comparison between Baseline value and Day 29 value.||3.83|-3.90|0.9847
71012509|NCT00612456|141532133|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on participants with a 'YES' for eligible field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|3.53|STANDARD_ERROR_OF_MEAN|1.376||0.0142|TWO_SIDED|95.0|0.75|6.31|||ANCOVA|||Comparison between Baseline value and Day 29 value.||6.31|0.75|0.0142
71012510|NCT00612456|141532133|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on participants with a 'YES' for eligible field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|0.85|STANDARD_ERROR_OF_MEAN|1.419||0.5547|TWO_SIDED|95.0|-2.02|3.71|||ANCOVA|||Comparison between Baseline value and Day 29 value.||3.71|-2.02|0.5547
71103884|NCT03322566|141715190|OTHER||Hazard Ratio (HR)|1.47||||0.94305|TWO_SIDED|95.0|0.91|2.36||One-sided p-value based on log-rank test stratified by TPS (\<50% vs \>=50%) and predominant histology (squamous vs non-squamous), because of small sample size, the strata 'TPS \>= 50% Non-squamous' and 'TPS \>= 50% Squamous' were combined into one.|Regression, Cox|Efron's method of tie handling||||2.36|0.91|0.94305
71012511|NCT00612456|141532133|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on participants with a 'YES' for eligible field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|2.287||0.9114|TWO_SIDED|95.0|-4.37|4.88|||ANCOVA|||Comparison between Baseline value and Day 29 value.||4.88|-4.37|0.9114
71012512|NCT00612456|141532136|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.383||0.0534|TWO_SIDED|95.0|-0.01|1.53|||ANCOVA|||Comparison between Baseline value and Day 29 value for FA Leakage Area of measurement.||1.53|-0.01|0.0534
71012513|NCT00612456|141532136|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.82|STANDARD_ERROR_OF_MEAN|0.409||0.0508|TWO_SIDED|95.0|0.0|1.64|||ANCOVA|||Comparison between Baseline value and Day 29 value for FA Leakage Area of measurement.||1.64|-0.00|0.0508
71012514|NCT00612456|141532136|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.61||||0.3141|TWO_SIDED|95.0|-0.6|1.83|||ANCOVA|||Comparison between Baseline value and Day 29 value for FA Leakage Area of measurement.||1.83|-0.60|0.3141
71012515|NCT00612456|141532136|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.395||0.6018|TWO_SIDED|95.0|-1.04|0.62|||ANCOVA|||Comparison between Baseline value and Day 29 value for FA Blood Area of measurement.||0.62|-1.04|0.6018
71012516|NCT00612456|141532136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.476||0.0509|TWO_SIDED|95.0|0.0|2.0||Statistics has been presented for least square means.|ANCOVA|||Comparison between Baseline value and Day 29 value for FA Blood Area of measurement.||2.00|-0.00|0.0509
71012517|NCT00612456|141532136|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.566||0.3976|TWO_SIDED|95.0|-0.7|1.68|||ANCOVA|||Comparison between Baseline value and Day 29 value for FA Blood Area of measurement.||1.68|-0.70|0.3976
71012518|NCT00612456|141532136|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.385||0.241|TWO_SIDED|95.0|-0.32|1.23|||ANCOVA|||Comparison between Baseline value and Day 29 value for Total Lesion size||1.23|-0.32|0.2410
71103885|NCT03322566|141715191|OTHER||Hazard Ratio (HR)|1.9||||0.96272|TWO_SIDED|95.0|0.93|3.9||One-sided p-value based on log-rank test stratified by PD-L1 TPS (\<50% vs \>=50%) and predominant tumor histology (squamous vs non-squamous), because of small sample size, the strata (\<50% vs \>=50%) were combined into one stratum.|Regression, Cox|||||3.90|0.93|0.96272
71103886|NCT05870345|141715195|OTHER|Sample size too small to perform additional statistical tests.|||||||||||||||||Sample size too small to perform additional statistical tests.|||
71103887|NCT05870345|141715196|OTHER|Sample size too small to perform additional statistical tests.|||||||||||||||||Sample size too small to perform additional statistical tests.|||
71103888|NCT00376558|141715197|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANOVA|||||||0.003
71103889|NCT00376558|141715198|SUPERIORITY_OR_OTHER||delta bpnd|-12.0|STANDARD_DEVIATION|7.0||0.001|TWO_SIDED|95.0|||||t-test, 2 sided|||The limbic striatum was our primary region of interest using an unpaired t test to compare BPND and deltaBPND between the treatment responders and non-responders.||||0.001
71103890|NCT02546323|141715199|OTHER||Estimated mean difference|-0.0103|STANDARD_ERROR_OF_MEAN|0.00445||0.02|TWO_SIDED|95.0|-0.0191|-0.0016||Statistical significance of the MeanMax CIMT annualized rate of change between rosuvastatin 20 mg and placebo was evaluated using time-by-treatment interaction term in the model.|Multi-level mixed effects model||Randomized treatment group, time, time-by-treatment interaction, ICVD risk stratification, carotid artery site, center, age, sex, and scan reader were fixed effects. Random effects were the intercept and slope for individual patients.|Comparison of annualized rate of change in MeanMax CIMT measurement difference between rosuvastatin 20 mg and placebo.||-0.0016|-0.0191|0.020
71103891|NCT02546323|141715200|OTHER||Estimated mean difference|-0.011|STANDARD_ERROR_OF_MEAN|0.00442||0.013|TWO_SIDED|95.0|-0.0197|-0.0024||Statistical significance of the MeanMax CIMT annualized rate of change between rosuvastatin 20 mg and placebo was evaluated using time-by-treatment interaction term in the model.|Multi-level mixed effects model||Randomized treatment group, time, time-by-treatment interaction, ICVD risk stratification, carotid artery site, center, age, sex, and scan reader were fixed effects. Random effects were the intercept and slope for individual patients.|Comparison of annualized rate of change in MeanMax CIMT measurement difference between rosuvastatin 20 mg and placebo.||-0.0024|-0.0197|0.013
71012519|NCT00612456|141532136|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|1.27|STANDARD_ERROR_OF_MEAN|0.412||0.0032|TWO_SIDED|95.0|0.44|2.09|||ANCOVA|||Comparison between Baseline value and Day 29 value for Total Lesion size||2.09|0.44|0.0032
71012520|NCT00612456|141532136|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.581||0.3185|TWO_SIDED|95.0|-0.58|1.75|||ANCOVA|||Comparison between Baseline value and Day 29 value for Total Lesion size||1.75|-0.58|0.3185
71012521|NCT00612456|141532136|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|0.377||0.1074|TWO_SIDED|95.0|-0.14|1.37|||ANCOVA|||Comparison between Baseline value and Day 29 value for CNV Size||1.37|-0.14|0.1074
71012522|NCT00612456|141532136|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.85|STANDARD_ERROR_OF_MEAN|0.402||0.0403|TWO_SIDED|95.0|0.04|1.65|||ANCOVA|||Comparison between Baseline value and Day 29 value for CNV Size||1.65|0.04|0.0403
71012523|NCT00612456|141532136|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.594||0.249|TWO_SIDED|95.0|-0.5|1.88|||ANCOVA|||Comparison between Baseline value and Day 29 value for CNV Size||1.88|-0.50|0.2490
71012524|NCT01258803|141532140|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.124|||<|0.001|TWO_SIDED|95.0|0.094|0.154|||ANCOVA|||"Pairwise Treatment Comparison of MF/F MDI with spacer and Placebo MDI combined with or without spacer.~Analysis was performed using an analysis of covariance (ANCOVA) model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."||0.154|0.094|<0.001
71103892|NCT02546323|141715201|OTHER||Estimated mean difference|-0.0162|STANDARD_ERROR_OF_MEAN|0.00903||0.073|TWO_SIDED|95.0|-0.0339|0.0015||Statistical significance of the MeanMax CIMT annualized rate of change between rosuvastatin 20 mg and placebo was evaluated using time-by-treatment interaction term in the model.|Multi-level mixed effects model||Randomized treatment group, time, time-by-treatment interaction, ICVD risk stratification, carotid artery site, center, age, sex, and scan reader were fixed effects. Random effects were the intercept and slope for individual patients.|Comparison of annualized rate of change in MeanMax CIMT measurement difference between rosuvastatin 20 mg and placebo.||0.0015|-0.0339|0.073
71012525|NCT01258803|141532141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.102|||<|0.001|TWO_SIDED|95.0|0.073|0.131|||ANCOVA|||"Pairwise Treatment Comparison of MF/F MDI without spacer and Placebo MDI combined with or without spacer.~Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."||0.131|0.073|<0.001
71012526|NCT01258803|141532142|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.022||||0.144|TWO_SIDED|95.0|-0.008|0.052|||ANCOVA|||"Pairwise Treatment Comparison of MF/F MDI with spacer and MF/F MDI without spacer.~Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."||0.052|-0.008|0.144
71012527|NCT01258803|141532144|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.018||||0.229|TWO_SIDED|95.0|-0.012|0.048|||ANCOVA|||"Pairwise Treatment Comparison of MF/F MDI with spacer and F DPI.~Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."||0.048|-0.012|0.229
71012528|NCT01258803|141532145|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.004||||0.79|TWO_SIDED|95.0|-0.033|0.025|||ANCOVA|||"Pairwise Treatment Comparison of MF/F MDI without spacer and F DPI.~Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."||0.025|-0.033|0.790
71012529|NCT01258803|141532146|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.106|||<|0.001|TWO_SIDED|95.0|0.077|0.135|||ANCOVA|||"Pairwise Treatment Comparison of F DPI and Placebo MDI combined with or without spacer.~Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."||0.135|0.077|<0.001
71012530|NCT04652245|141532152|SUPERIORITY|||||||0.028|||||||ANCOVA|||||||0.028
71012531|NCT04652245|141532153|SUPERIORITY|||||||0.008|||||||ANCOVA|||||||0.008
71012532|NCT04419558|141532157|OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.077||0.6579|TWO_SIDED|95.0|-0.12|0.19|||Mixed Models Analysis|||||0.19|-0.12|0.6579
71012533|NCT05146999|141532167|SUPERIORITY||Treatment difference|83.8|||<|0.001|TWO_SIDED|95.0|72.81|94.87|||Cochran-Mantel-Haenszel|||||94.87|72.81|<0.001
71012534|NCT02309372|141532211|SUPERIORITY||Mean Difference (Net)|-0.76||||0.32|TWO_SIDED|95.0|-2.28|0.77|||t-test, 2 sided|||||0.77|-2.28|0.32
71012535|NCT02129192|141532215|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of Cmax of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|95.77|||||TWO_SIDED|90.0|88.89|103.17|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for telmisartan 80 mg||103.17|88.89|
71012536|NCT02129192|141532215|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of Cmax of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|101.4|||||TWO_SIDED|90.0|99.7|103.13|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for amlodipine 5 mg||103.13|99.70|
71012537|NCT02129192|141532215|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of Cmax of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|101.77|||||TWO_SIDED|90.0|98.46|105.19|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for hydrochlorothiazide 12.5 mg||105.19|98.46|
71012538|NCT02129192|141532216|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|30.15||||1|TWO_SIDED|90.0|24.99|36.38|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for telmisartan 80 mg. No hypothesis was tested.||36.38|24.99|1.0000
71012539|NCT02129192|141532216|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|98.23|||<|0.0001|TWO_SIDED|90.0|94.63|101.97|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for amlodipine 5 mg. No hypothesis was tested.||101.97|94.63|<0.0001
71012540|NCT02129192|141532216|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|79.69||||0.5422|TWO_SIDED|90.0|74.97|84.71|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for hydrochlorothiazide 12.5 mg. No hypothesis was tested.||84.71|74.97|0.5422
71012541|NCT02129192|141532217|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-tz of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|99.21|||||TWO_SIDED|90.0|96.14|102.38|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for telmisartan 80 mg||102.38|96.14|
71012542|NCT02129192|141532217|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-tz of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|101.43||||||90.0|99.84|103.04|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for amlodipine 5 mg||103.04|99.84|
71012543|NCT02129192|141532217|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-tz of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|100.33|||||TWO_SIDED|90.0|98.29|102.4|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for hydrochlorothiazide 12.5 mg||102.40|98.29|
71047475|NCT00361335|141603943|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups III vs V at 0.05 level of significance.||||0.014
71047476|NCT00361335|141603943|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups I and VII at 0.05 level of significance.||||0.996
71047477|NCT00361335|141603943|SUPERIORITY_OR_OTHER|||||||0.738||95.0|||||2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups II vs V at 0.05 level of significance.||||0.738
71047478|NCT00361335|141603943|SUPERIORITY_OR_OTHER|||||||0.788||95.0||||No adjustments were made to control for multiplicity|2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance.||||0.788
71103893|NCT02546323|141715202|OTHER||Estimated mean difference|-0.0043|STANDARD_ERROR_OF_MEAN|0.00716||0.547|TWO_SIDED|95.0|-0.0183|0.0097||Statistical significance of the MeanMax CIMT annualized rate of change between rosuvastatin 20 mg and placebo was evaluated using time-by-treatment interaction term in the model.|Multi-level mixed effects model||Randomized treatment group, time, time-by-treatment interaction, ICVD risk stratification, carotid artery site, center, age, sex, and scan reader were fixed effects. Random effects were the intercept and slope for individual patients.|Comparison of annualized rate of change in MeanMax CIMT measurement difference between rosuvastatin 20 mg and placebo.||0.0097|-0.0183|0.547
70928728|NCT04800211|141353086|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-35.811||||0.8954|TWO_SIDED|95.0|-132.513|60.891|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||60.891|-132.513|0.8954
71012544|NCT02129192|141532218|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|63.66||||1|TWO_SIDED|90.0|58.98|68.71|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for telmisartan 80 mg. No hypothesis was tested.||68.71|58.98|1.0000
71012545|NCT02129192|141532218|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|99.74|||<|0.0001|TWO_SIDED|90.0|97.08|102.48|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for amlodipine 5 mg. No hypothesis was tested.||102.48|97.08|<0.0001
71012546|NCT02129192|141532218|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|89.66||||0.0001|TWO_SIDED|90.0|85.8|93.7|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for hydrochlorothiazide 12.5 mg. No hypothesis was tested.||93.70|85.80|0.0001
71012547|NCT02129192|141532219|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-inf of the two treatments was within the pre-specified acceptance range (80%-125%).|Adjusted geometric mean ratio (%)|99.62|||||TWO_SIDED|90.0|96.32|103.04|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for telmisartan 80 mg||103.04|96.32|
71012548|NCT02129192|141532219|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-inf of the two treatments was within the pre-specified acceptance range (80%-125%).|Adjusted geometric mean ratio (%)|101.21|||||TWO_SIDED|90.0|99.59|102.87|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for amlodipine 5 mg||102.87|99.59|
71012549|NCT02129192|141532219|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-inf of the two treatments was within the pre-specified acceptance range (80%-125%).|Adjusted geometric mean ratio (%)|100.15|||||TWO_SIDED|90.0|98.23|102.1|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for hydrochlorothiazide 12.5 mg||102.10|98.23|
71012550|NCT02129192|141532220|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|64.4||||1|TWO_SIDED|90.0|59.59|69.59|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for telmisartan 80 mg. No hypothesis was tested.||69.59|59.59|1.0000
71012551|NCT02129192|141532220|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|99.45|||<|0.0001|TWO_SIDED|90.0|96.69|102.29|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for amlodipine 5 mg. No hypothesis was tested.||102.29|96.69|<0.0001
71012552|NCT02129192|141532220|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|89.82|||<|0.0001|TWO_SIDED|90.0|86.02|93.79|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for hydrochlorothiazide 12.5 mg. No hypothesis was tested.||93.79|86.02|<0.0001
71012553|NCT01231620|141532224|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.73||||0.25|TWO_SIDED|95.0|-1.79|0.75|||Wilcoxon rank sum||IV Zanamivir 300 mg versus IV Zanamivir 600 mg|||0.75|-1.79|0.25
71012554|NCT01231620|141532224|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.48||||0.39|TWO_SIDED|95.0|-2.11|0.97|||Wilcoxon rank sum||Oral oseltamivir 75 mg versus IV Zanamivir 600 mg|||0.97|-2.11|0.39
71012555|NCT01231620|141532225|SUPERIORITY_OR_OTHER|||||||0.506|||||||Wei-Johnson method|||||||0.506
71012556|NCT01231620|141532225|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wei-Johnson method|||||||0.41
71012557|NCT00412360|141532257|SUPERIORITY|||||||0.17||||||Testing was performed at a significance level of 0.05|Log Rank|||The null hypothesis is that there is no difference in overall survival at one year post-randomization between participants receiving single- and double-unit cord blood transplant. The targeted sample size of 110 participants per treatment group was sufficient to maintain a type I error rate of 5% and provide more than 86% power to detect an increase in overall survival from 57% among participants receiving a single unit graft to 77% for those receiving a double-unit graft.||||0.17
71117593|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|0.79||||0.881|TWO_SIDED|95.0|-9.42|10.99||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.99|-9.42|0.881
71012558|NCT00412360|141532258|SUPERIORITY|||||||0.11||||||Testing was performed at a significance level of 0.05|Log Rank|||The null hypothesis is that there is no difference in disease-free survival at one year post-randomization between participants receiving single- and double-unit cord blood transplant.||||0.11
71012559|NCT00412360|141532259|SUPERIORITY|||||||0.29||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of neutrophil engraftment between participants receiving single- and double-unit cord blood transplant.||||0.29
71012560|NCT00412360|141532259|SUPERIORITY|||||||0.04||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of platelet engraftment between participants receiving single- and double-unit cord blood transplant.||||0.04
71012561|NCT00412360|141532261|SUPERIORITY|||||||0.78||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of Grade II-IV acute GVHD between participants receiving single- and double-unit cord blood transplant.||||0.78
71012562|NCT00412360|141532261|SUPERIORITY|||||||0.02||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of Grade III-IV acute GVHD between participants receiving single- and double-unit cord blood transplant.||||0.02
71012563|NCT00412360|141532262|SUPERIORITY|||||||0.51||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of chronic GVHD between participants receiving single- and double-unit cord blood transplant.||||0.51
71012564|NCT00412360|141532262|SUPERIORITY|||||||0.05||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of extensive chronic GVHD between participants receiving single- and double-unit cord blood transplant.||||0.05
71012565|NCT00412360|141532264|SUPERIORITY|||||||0.12||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of relapse between participants receiving single- and double-unit cord blood transplant.||||0.12
71012566|NCT00412360|141532265|SUPERIORITY|||||||0.43||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of treatment-related mortality between participants receiving single- and double-unit cord blood transplant.||||0.43
71012567|NCT02486263|141532314|SUPERIORITY|||||||0.28||||||The threshold for statistical significance was \<0.05.|Chi-squared|||||||0.28
71012568|NCT02486263|141532315|SUPERIORITY||Odds Ratio (OR)|0.8||||0.99|TWO_SIDED|95.0|0.4|1.6||Used Bonferroni adjustment for multiple comparisons. Threshold for statistical significance was p\<0.05|Generalized Estimation Equation||Data presented as OR (95% CI) using Generalized Estimation Equation (GEE) model with Conventional as reference.|Generalized Estimation Equation (GEE) model was used for the comparison of differences between intervention groups from week 0 to week 5 for peristaltic response frequency.||1.6|0.4|0.99
71012569|NCT02486263|141532316|SUPERIORITY|Weight velocity in grams/day||||||0.64|||||||t-test, 2 sided|||||||0.64
71047479|NCT00986180|141603958|NON_INFERIORITY_OR_EQUIVALENCE|The sample size was recalculated due to Amendment INT-1. The non-inferiority margin for SPID120 was set as 120. The common standard deviation for the SPID120 data was estimated to be 230. Seventy nine subjects in each arm would have 90% power to demonstrate the non-inferiority of NUCYNTA to oxycodone IR with a 1-sided significance level of 0.025. This would have required enrollment of total 158 mITT subjects for each stratum. The original sample size (292 mITT subjects) was derived for SPID72.|Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|16.02||0.9703|TWO_SIDED|95.0|-32.1|30.9|||ANCOVA|||||30.9|-32.1|0.9703
71047480|NCT00986180|141603959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|6.08||0.7691|TWO_SIDED|95.0|-10.1|13.7|||ANCOVA|||||13.7|-10.1|0.7691
71047481|NCT00986180|141603960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|9.24||0.9282|TWO_SIDED|95.0|-17.3|19.0|||ANCOVA|||||19.0|-17.3|0.9282
71047482|NCT00986180|141603961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|29.75||0.9562|TWO_SIDED|95.0|-60.1|56.8|||ANCOVA|||||56.8|-60.1|0.9562
71047483|NCT00986180|141603962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|6.08||0.7973|TWO_SIDED|95.0|-13.5|10.4|||ANCOVA|||||10.4|-13.5|0.7973
71047484|NCT00986180|141603963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|9.3||0.7882|TWO_SIDED|95.0|-20.8|15.8|||ANCOVA|||||15.8|-20.8|0.7882
71047485|NCT00986180|141603964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1|STANDARD_ERROR_OF_MEAN|15.82||0.7491|TWO_SIDED|95.0|-36.1|26.0|||ANCOVA|||||26.0|-36.1|0.7491
71047486|NCT00986180|141603965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|29.03||0.6897|TWO_SIDED|95.0|-68.6|45.4|||ANCOVA|||||45.4|-68.6|0.6897
71012570|NCT02486263|141532317|SUPERIORITY|||||||0.11|||||||Chi-squared|||||||0.11
71012571|NCT02486263|141532318|SUPERIORITY|||||||0.49||||||Threshold for statistical significance \<0.05|Chi-squared|||||||0.49
71012572|NCT00976521|141532331|SUPERIORITY_OR_OTHER|||||||0.034||95.0|||||Wilcoxon (Mann-Whitney)|||The primary endpoint of infarct size at 30 days measured by cardiac MRI, was summarized using the median, IQR, minimum and maximum values, in each infusion group, comparing the pooled active infusion arm to the pooled control non-infusion arm with the Wilcoxon rank sum test in the ITT analysis set. Data was only analyzed in subjects completing the cardiac MRI study and for whom the imaging data was received and deemed analyzable by the core laboratory.||||0.034
71047487|NCT00986180|141603966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|7.02||0.8226|TWO_SIDED|95.0|-12.2|15.4|||ANCOVA|||||15.4|-12.2|0.8226
71047488|NCT00986180|141603967|SUPERIORITY_OR_OTHER|||||||0.888|||||||Wilcoxon (Mann-Whitney)|||||||0.8880
71047489|NCT00986180|141603968|SUPERIORITY_OR_OTHER|||||||0.4115|||||||Wilcoxon (Mann-Whitney)|||||||0.4115
71047490|NCT00986180|141603969|SUPERIORITY_OR_OTHER|||||||0.8495|||||||Wilcoxon (Mann-Whitney)|||||||0.8495
71047491|NCT00986180|141603970|SUPERIORITY_OR_OTHER|||||||0.7846|||||||Wilcoxon (Mann-Whitney)|||||||0.7846
71047492|NCT00986180|141603971|SUPERIORITY_OR_OTHER|||||||0.479|||||||Wilcoxon (Mann-Whitney)|||||||0.4790
71047493|NCT00986180|141603972|SUPERIORITY_OR_OTHER|||||||0.3147|||||||Wilcoxon (Mann-Whitney)|||||||0.3147
71047494|NCT00986180|141603973|SUPERIORITY_OR_OTHER|||||||0.5411|||||||Wilcoxon (Mann-Whitney)|||||||0.5411
71047495|NCT00986180|141603974|SUPERIORITY_OR_OTHER|||||||0.6137|||||||Wilcoxon (Mann-Whitney)|||||||0.6137
71047496|NCT00986180|141603975|SUPERIORITY_OR_OTHER|||||||0.7246|||||||Wilcoxon (Mann-Whitney)|||||||0.7246
71047497|NCT00986180|141603976|SUPERIORITY_OR_OTHER|||||||0.4882|||||||Wilcoxon (Mann-Whitney)|||||||0.4882
71047498|NCT00986180|141603977|SUPERIORITY_OR_OTHER|||||||0.7201|||||||Cochran-Mantel-Haenszel|||||||0.7201
71103894|NCT02546323|141715203|OTHER||Estimated mean difference|-0.0086|STANDARD_ERROR_OF_MEAN|0.00272||0.002|TWO_SIDED|95.0|-0.0139|-0.0032||Statistical significance of the MeanMean CIMT annualized rate of change between rosuvastatin 20 mg and placebo was evaluated using time-by-treatment interaction term in the model.|Multi-level mixed effects model||Randomized treatment group, time, time-by-treatment interaction, ICVD risk stratification, carotid artery site, center, age, sex, and scan reader were fixed effects. Random effects were the intercept and slope for individual patients|Comparison of annualized rate of change in MeanMean CIMT measurement difference between rosuvastatin 20 mg and placebo||-0.0032|-0.0139|0.002
71103895|NCT02546323|141715204|OTHER||Least squares mean difference|-35.46|STANDARD_ERROR_OF_MEAN|2.426|<|0.001|TWO_SIDED|95.0|-40.23|-30.7|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): LDL-C||-30.70|-40.23|<0.001
71103896|NCT02546323|141715204|OTHER||Least squares mean difference|-21.85|STANDARD_ERROR_OF_MEAN|1.441|<|0.001|TWO_SIDED|95.0|-24.68|-19.02|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): total cholesterol||-19.02|-24.68|<0.001
71103897|NCT02546323|141715204|OTHER||Least squares mean difference|5.0|STANDARD_ERROR_OF_MEAN|1.347|<|0.001|TWO_SIDED|95.0|2.35|7.64|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): HDL-C||7.64|2.35|<0.001
70941410|NCT02567227|141383494|SUPERIORITY||Mean Difference (Net)|1.13|STANDARD_ERROR_OF_MEAN|1.42|||TWO_SIDED|95.0|-1.65|3.91|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in gait speed during normal walking pre and 6 months post intervention.||3.91|-1.65|
71047499|NCT00986180|141603979|SUPERIORITY_OR_OTHER|||||||0.5208|||||||Cochran-Mantel-Haenszel|||||||0.5208
71047500|NCT00986180|141603981|SUPERIORITY_OR_OTHER|||||||0.0401|||||||Cochran-Mantel-Haenszel|||||||0.0401
71047501|NCT00986180|141603983|SUPERIORITY_OR_OTHER|||||||0.4679|||||||Cochran-Mantel-Haenszel|||||||0.4679
71047502|NCT00986180|141603985|SUPERIORITY_OR_OTHER|||||||0.1454|||||||Fisher Exact|||||||0.1454
71047503|NCT00986180|141603986|SUPERIORITY_OR_OTHER|||||||0.1541|||||||Fisher Exact|||||||0.1541
71047504|NCT00986180|141603988|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38|||||TWO_SIDED|95.0|0.92|2.06|||Cochran-Mantel-Haenszel|||||2.06|0.92|
71103898|NCT02546323|141715204|OTHER||Least squares mean difference|-19.65|STANDARD_ERROR_OF_MEAN|3.671|<|0.001|TWO_SIDED|95.0|-26.86|-12.44|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Triglycerides||-12.44|-26.86|<0.001
71103899|NCT02546323|141715204|OTHER||Least squares mean difference|-29.49|STANDARD_ERROR_OF_MEAN|1.917|<|0.001|TWO_SIDED|95.0|-33.25|-25.72|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Non-HDL-C||-25.72|-33.25|<0.001
71103900|NCT02546323|141715204|OTHER||Least squares mean difference|-31.75|STANDARD_ERROR_OF_MEAN|2.334|<|0.001|TWO_SIDED|95.0|-36.33|-27.16|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Non-HDL-C/HDL-C ratio||-27.16|-36.33|<0.001
71103901|NCT02546323|141715204|OTHER||Least squares mean difference|-26.12|STANDARD_ERROR_OF_MEAN|1.84|<|0.001|TWO_SIDED|95.0|-29.73|-22.5|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): ApoB||-22.50|-29.73|<0.001
71103902|NCT02546323|141715204|OTHER||Least squares mean difference|2.19|STANDARD_ERROR_OF_MEAN|1.104||0.047|TWO_SIDED|95.0|0.02|4.36|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate|Treatment difference (rosuvastatin 20 mg - placebo): ApoA-I||4.36|0.02|0.047
71047505|NCT00986180|141603989|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74|||||TWO_SIDED|95.0|1.17|2.57|||Cochran-Mantel-Haenszel|||||2.57|1.17|
71047506|NCT00986180|141603990|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.43|||||TWO_SIDED|95.0|1.45|8.11|||Cochran-Mantel-Haenszel|||||8.11|1.45|
71047507|NCT00986180|141603991|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.54|1.67|||Cochran-Mantel-Haenszel|||||1.67|0.54|
71047508|NCT00986180|141603992|SUPERIORITY_OR_OTHER|||||||0.5828|||||||Log Rank|||||||0.5828
71047509|NCT00986180|141603993|SUPERIORITY_OR_OTHER|||||||0.9084|||||||Log Rank|||||||0.9084
71047510|NCT01765582|141603994|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.132|TWO_SIDED|90.0|0.96|2.71|||Cochran-Mantel-Haenszel|||Stratified by extent of metastatic disease (liver-limited disease versus non liver-limited disease) and tumor location (right versus left) after correction post-randomization.||2.71|0.96|0.132
71047511|NCT01765582|141603995|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.005|TWO_SIDED|90.0|0.53|0.88|||Log Rank|||Stratified by extent of metastatic disease (liver-limited disease vs. non-liver-limited disease) and tumor location (right vs. left) after correction post-randomization.||0.88|0.53|0.005
71047512|NCT03261960|141604031|NON_INFERIORITY|Non-inferiority margin was set at 10%.|||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71047513|NCT00714493|141604059|SUPERIORITY_OR_OTHER||change from baseline||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
71047514|NCT00714493|141604060|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
71077869|NCT02913105|141664398|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.93||||0.0096|TWO_SIDED|90.0|0.88|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 14||0.97|0.88|0.0096
71012573|NCT00976521|141532332|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Wilcoxon (Mann-Whitney)|||The primary endpoint of infarct size at 30 days measured by cardiac MRI, was summarized using the median, IQR, minimum and maximum values, in each infusion group, comparing the pooled active infusion arm to the pooled control non-infusion arm with the Wilcoxon rank sum test in the ITT analysis set. Data was only analyzed in subjects completing the cardiac MRI study and for whom the imaging data was received and deemed analyzable by the core laboratory.||||0.51
71012574|NCT03039699|141532336|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
71012575|NCT03039699|141532337|SUPERIORITY|||||||0.0675||||||p-value adjusted for multiple comparisons using Holm method|Fisher Exact|||48 hours timepoint comparison||||0.0675
71012576|NCT03039699|141532337|SUPERIORITY|||||||0.0675||||||p-value adjusted for multiple comparisons using Holm method|Fisher Exact|||72 hours timepoint comparison||||0.0675
71012577|NCT03039699|141532337|SUPERIORITY|||||||0.5569||||||p-value adjusted for multiple comparisons using Holm method|Fisher Exact|||96 hours timepoint comparison||||0.5569
71012578|NCT03039699|141532338|SUPERIORITY|||||||0.0696||||||p-value adjusted for multiple comparisons using Holm method|Fisher Exact|||48 hours timepoint comparison||||0.0696
71012579|NCT03039699|141532338|SUPERIORITY|||||||0.0696||||||p-value adjusted for multiple comparisons using Holm method|Fisher Exact|||72 hours timepoint comparison||||0.0696
71012580|NCT03039699|141532338|SUPERIORITY|||||||0.1998||||||p-value adjusted for multiple comparisons using Holm method|Fisher Exact|||96 hours timepoint comparison||||0.1998
71012581|NCT03039699|141532339|SUPERIORITY|||||||0.0039|||||||Wilcoxon (Mann-Whitney)|||||||0.0039
71047515|NCT00557076|141604084|NON_INFERIORITY_OR_EQUIVALENCE|Because 50% of the planned sample size was randomized, achieved power for the DOCS is 0.51.|Mean Difference (Final Values)|5.4|STANDARD_ERROR_OF_MEAN|7.0||0.465|TWO_SIDED|95.0|-11.1|21.9|||t-test, 1 sided|DOCS scores were transformed to interval level measures using a many-faceted Rasch model anchored to values from a larger validation data set|The mean difference between the baseline and endpoint DOCS test was compared between the FAST and Sham groups.|The planned sample of 15 per group provided 80% power for a one-sided t-test to detect be-tween group endpoint differences in DOCS averages equivalent to an effect size of .91 (9 units). Clinically, this assumes that the FAST protocol would facilitate progression from one clinical state to another (e.g., vegetative (VS) to minimally conscious (MCS) states). The hypothesized effect was based on average DOCS change for a severe TBI sample receiving three weeks of acute rehabilitation.||21.9|-11.1|.465
71047516|NCT00557076|141604085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|0.346||0.049|TWO_SIDED|95.0|-1.51|-0.00493|||t-test, 1 sided|CNC scores were transformed to interval level measures using Rasch partial credit and Facets models. We then re-scaled these logits to 0-100 scales.|The mean difference was calculated for each group using the eighth CNC measure minus the Baseline CNC measure.|Power was not calculated for the CNC because the effect size was not published.||-.00493|-1.51|0.049
71103903|NCT02546323|141715204|OTHER||Least squares mean difference|-26.77|STANDARD_ERROR_OF_MEAN|2.041|<|0.001|TWO_SIDED|95.0|-30.78|-22.76|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): ApoB/ApoA-I ratio||-22.76|-30.78|<0.001
71103904|NCT02546323|141715205|OTHER||Least squares mean difference|-39.51|STANDARD_ERROR_OF_MEAN|1.819|<|0.001|TWO_SIDED|95.0|-43.08|-35.94|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): LDL-C||-35.94|-43.08|<0.001
71103905|NCT02546323|141715205|OTHER||Least squares mean difference|-25.46|STANDARD_ERROR_OF_MEAN|1.139|<|0.001|TWO_SIDED|95.0|-27.7|-23.23|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): total cholesterol||-23.23|-27.70|<0.001
71012582|NCT03039699|141532340|SUPERIORITY|||||||0.89||||||"The p-value associated with treatment\*visit interaction of total CDS score from 24 hours to 48 and 72 hours of treatment between Ergoferon and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.89
71012583|NCT03039699|141532341|SUPERIORITY|||||||0.0044|||||||Wilcoxon (Mann-Whitney)|||||||0.0044
71012584|NCT03039699|141532342|SUPERIORITY|||||||0.5488||||||nonadjusted p-value|Fisher Exact|||Day 3 comparison||||0.5488
71012585|NCT03039699|141532342|SUPERIORITY|||||||0.814||||||nonadjusted p-value|Fisher Exact|||Day 4 comparison||||0.8140
71012586|NCT03039699|141532342|SUPERIORITY|||||||0.1248||||||nonadjusted p-value|Fisher Exact|||Day 6 comparison||||0.1248
71012587|NCT03039699|141532342|SUPERIORITY|||||||0.3889||||||nonadjusted p-value|Fisher Exact|||Day 10 comparison||||0.3889
71012588|NCT03039699|141532343|SUPERIORITY|||||||0.3593|||||||Fisher Exact|||||||0.3593
71012589|NCT02985541|141532344|OTHER||3-year probability of getting pregnant|0.68|||||TWO_SIDED|95.0|0.17|2.71||||||Cumulative failure rate (Kaplan-Meier) during Years 6-8||2.71|0.17|
71012590|NCT01982942|141532364|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||The null hypothesis states that the BPF rates of change in the treatment and placebo groups are equal, which can be evaluated based on as assessment of parameter estimates from a linear mixed model (LMM).||||0.04
71012591|NCT02918968|141532382|SUPERIORITY|The significance level was 0.05 (two-sided).|Hazard Ratio (HR)|0.42|||<|0.001|TWO_SIDED|95.0|0.29|0.61||P-value is based on a log-rank test stratified disease stages (M0/N0, M0/N1, or M1).|Log Rank||Hazard ratio and P-value calculated using unstratified Cox proportional hazards model with treatment and disease stages (M0/N0, M0/N1, or M1) as covariate.|||0.61|0.29|<0.001
71012592|NCT02918968|141532384|SUPERIORITY|The significance level was 0.05 (two-sided).|Risk Difference (RD)|37.8|||<|0.001|TWO_SIDED|95.0|25.2|50.4||P-value is based on Cochran-Mantel-Haenszel mean score test stratified disease stages (M0/N0, M0/N1, or M1).|Mantel Haenszel|Mantel Haenszel common risk difference|Difference of response rate.|\>=50% reduction||50.4|25.2|<0.001
71012593|NCT02918968|141532384|SUPERIORITY|The significance level was 0.05 (two-sided).|Risk Difference (RD)|38.4|||<|0.001|TWO_SIDED|95.0|26.3|50.4||P-value is based on Cochran-Mantel-Haenszel mean score test stratified disease stages (M0/N0, M0/N1, or M1).|Mantel Haenszel|Mantel Haenszel common risk difference|Difference of response rate|≥ 90% reduction||50.4|26.3|<0.001
71012594|NCT02918968|141532385|SUPERIORITY|The significance level was 0.05 (two-sided).|Risk Difference (RD)|40.7|||<|0.001|TWO_SIDED|95.0|28.3|53.1||P-value is based on Cochran-Mantel-Haenszel mean score test stratified disease stages (M0/N0, M0/N1, or M1).|Mantel Haenszel|Mantel Haenszel common risk difference|Difference of response rate.|≥ 50% reduction||53.1|28.3|<0.001
71012595|NCT02918968|141532385|SUPERIORITY|The significance level was 0.05 (two-sided).|Risk Difference (RD)|33.5|||<|0.001|TWO_SIDED|95.0|21.5|45.4||P-value is based on Cochran-Mantel-Haenszel mean score test stratified disease stages (M0/N0, M0/N1, or M1).|Mantel Haenszel|Mantel Haenszel common risk difference|Difference of response rate|≥90% reduction||45.4|21.5|<0.001
71012596|NCT02918968|141532386|SUPERIORITY|The significance level was 0.05 (two-sided).|||||<|0.001||||||P-value is based on a log-rank test stratified disease stages (M0/N0, M0/N1, or M1).|Log Rank|||||||<0.001
71012597|NCT02918968|141532387|SUPERIORITY|The significance level was 0.05 (two-sided).|||||<|0.001||||||P-value is based on a log-rank test stratified disease stages (M0/N0, M0/N1, or M1).|Log Rank|||||||<0.001
71012598|NCT02918968|141532389|SUPERIORITY|The significance level was 0.05 (two-sided).|Hazard Ratio (HR)|0.87||||0.669|TWO_SIDED|95.0|0.45|1.67||P-value is based on a log-rank test stratified disease stages (M0/N0, M0/N1, or M1)|Log Rank||Hazard ratio and P-value calculated using unstratified Cox proportional hazards model with treatment and disease stages (M0/N0, M0/N1, or M1) as covariate.|||1.67|0.45|0.669
71012599|NCT00727246|141532390|OTHER|||||||0.85|TWO_SIDED|95.0|||||ANOVA|A repeated measures ANOVA was completed to evaluate differences in cognitive composite scores between groups and CDP-Choline or placebo||A repeated measures ANOVA was completed to evaluate differences in cognitive composite scores of individuals with a history of TBI as compared to healthy controls 6 weeks after treatment with CDP Choline (1000 mg CDP-Choline 2 x per day for 6 weeks) as compared to those treated with placebo. A mean index score created as a composite cognitive performance across domains (higher t-score = higher cognition). Purpose was to serve as a measure of overall cognitive functioning for data analysis.||||.85
71012600|NCT00727246|141532391|OTHER|||||||0.329|TWO_SIDED|0.95|||||ANOVA|A repeated measures ANOVA was completed to evaluate differences in cognitive composite scores between groups and CDP-Choline or placebo||A repeated measure ANOVA was completed to evaluate potential differences in cognitive composite scores of individuals with a history of TBI as compared to healthy controls 6 weeks after treatment with CDP Choline (1000 mg CDP-Choline 2 x per day for 6 weeks) as compared to those treated with placebo.||||.329
71012601|NCT04988035|141532484|SUPERIORITY||Odds Ratio (OR)|0.64||||0.09|TWO_SIDED|95.0|0.38|1.07|||Proportional odds model||Odds ratio greater than 1 favors Remdesivir plus Danicopan.|Includes all ordinal score categories. Odds ratio of a better clinical status score, confidence interval and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using multiple imputation (MI) for participants lost to follow-up before Day 8 while hospitalized, in hospice, long term acute care, or transferred to other hospital while those participants lost to follow-up after discharge to home are assigned a score of 2.||1.07|0.38|0.090
71012602|NCT04988035|141532485|SUPERIORITY||Odds Ratio (OR)|0.69||||0.358|TWO_SIDED|95.0|0.31|1.53|||Regression, Logistic|||Odds ratio, confidence interval, and p-value estimated from a logistic regression model adjusted for baseline dexamethasone use, baseline ordinal score, age, and baseline C-Reactive Protein (CRP).|Odds ratio greater than 1 favors Remdesivir plus Danicopan|1.53|0.31|0.358
71012603|NCT04988035|141532486|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.014|TWO_SIDED|95.0|0.46|0.92|||Regression, Cox||HR greater than 1 favors Remdesivir plus Danicopan.|Hazard ratio, confidence interval, and p-value estimated from a Cox model adjusted for baseline steroid use and baseline ordinal score.||0.92|0.46|0.014
71012604|NCT04988035|141532487|SUPERIORITY||Odds Ratio (OR)|0.7||||0.177|TWO_SIDED|95.0|0.42|1.17|||Proportional odds model||Odds ratio above 1 favors Remdesivir plus Danicopan.|Includes all ordinal score categories. OR of a better clinical status score, confidence interval, and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using last observation carried forward for participants lost to follow-up before Day 15 while hospitalized, in hospice, long term acute care, or transferred to other hospital. Participants lost to follow-up before Day 15 after discharge are given a score of 2.||1.17|0.42|0.177
71047517|NCT00557076|141604085|SUPERIORITY_OR_OTHER||Slope|-0.63|STANDARD_ERROR_OF_MEAN|0.2||0.0022|TWO_SIDED|||||To confirm that CNC results were not an anomaly at the final measurement and that the overall CNC response pattern was consistent, mixed-effect longitudinal models were conducted.|t-test, 1 sided||The Baseline CNC measure and seven post-Baseline CNC measures (for a total of eight CNC measures) were used to calculate the slope.|||||.0022
70850355|NCT00947882|141188492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.62||||0.0367||||||P-values based on Williams' extended trend test of comparison vs. placebo at Month 4. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 30 mg and Placebo at Month 4."|ANCOVA of the change from baseline in IPSS at Months 4 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.0367
71012605|NCT04988035|141532488|SUPERIORITY||Odds Ratio (OR)|0.81||||0.427|TWO_SIDED|95.0|0.48|1.36|||Proportional odds model|||Includes all ordinal score categories. OR of a better clinical status score, confidence interval, and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using last observation carried forward for participants lost to follow-up before Day 29 while hospitalized, in hospice, long term acute care, or transferred to other hospital. Participants lost to follow-up before Day 29 after discharge are given a score of 2.|Odds ratio above 1 favors Remdesivir plus Danicopan.|1.36|0.48|0.427
71012606|NCT04988035|141532523|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.109|TWO_SIDED|95.0|0.56|1.06|||Regression, Cox||HR greater than 1 favors Remdesivir plus Danicopan.|||1.06|0.56|0.109
71012607|NCT04988035|141532524|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.036|TWO_SIDED|95.0|0.51|0.98|||Regression, Cox||||HR greater than 1 favors Remdesivir plus Danicopan.|0.98|0.51|0.036
71012608|NCT03602976|141532526|SUPERIORITY||Mean Difference (Final Values)|190.7||||0.059|TWO_SIDED||||||t-test, 2 sided|||For GGT||||0.059
71012609|NCT03602976|141532526|SUPERIORITY||Mean Difference (Final Values)|55.5||||0.23|TWO_SIDED||||||t-test, 2 sided|||For Alkaline Phosphatase||||0.23
71012610|NCT03602976|141532527|SUPERIORITY||Mean Difference (Final Values)|2.06||||0.36|TWO_SIDED||||||t-test, 2 sided|||||||0.36
71047518|NCT02408068|141604091|SUPERIORITY_OR_OTHER_LEGACY||Geometric LSmean ratio|77.56|||||TWO_SIDED|90.0|70.89|84.86|||ANOVA|||Results obtained using a mixed effects ANOVA with fixed effects for study period, sequence, treatment and subject (sequence) (excl. tmax).||84.86|70.89|
70941411|NCT02567227|141383494|SUPERIORITY||Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|1.79|||TWO_SIDED|95.0|-2.12|4.91|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in gait speed during walking while talking pre and 6 months post intervention.||4.91|-2.12|
71103906|NCT02546323|141715205|OTHER||Least squares mean difference|3.67|STANDARD_ERROR_OF_MEAN|1.051|<|0.001|TWO_SIDED|95.0|1.6|5.73|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): HDL-C||5.73|1.60|<0.001
71103907|NCT02546323|141715205|OTHER||Least squares mean difference|-18.41|STANDARD_ERROR_OF_MEAN|2.981|<|0.001|TWO_SIDED|95.0|-24.26|-12.55|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Triglycerides||-12.55|-24.26|<0.001
71012611|NCT03602976|141532528|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.73|TWO_SIDED||||||t-test, 2 sided|||||||0.73
71012612|NCT03602976|141532529|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.094|TWO_SIDED||||||t-test, 2 sided|||||||0.094
71012613|NCT03602976|141532530|SUPERIORITY||Mean Difference (Final Values)|21.0||||0.11|TWO_SIDED||||||t-test, 2 sided|||||||0.11
71012614|NCT04278846|141532565|SUPERIORITY|||||||0.87|||||||Kruskal-Wallis|||||||.87
71012615|NCT04278846|141532566|SUPERIORITY|||||||0.49|||||||Kruskal-Wallis|||||||.49
71012616|NCT04278846|141532567|SUPERIORITY|||||||0.57|||||||Kruskal-Wallis|||||||.57
71012617|NCT04278846|141532568|SUPERIORITY|||||||0.3|||||||Kruskal-Wallis|||||||.3
71012618|NCT04278846|141532569|SUPERIORITY|||||||0.99|||||||Kruskal-Wallis|||||||.99
71012619|NCT04278846|141532570|SUPERIORITY|||||||0.33|||||||Kruskal-Wallis|||||||.33
71012620|NCT04278846|141532571|SUPERIORITY|||||||0.26|||||||Kruskal-Wallis|||||||.26
71012621|NCT04278846|141532572|SUPERIORITY|||||||0.79|||||||Kruskal-Wallis|||||||.79
71012622|NCT04278846|141532573|SUPERIORITY|||||||0.62|||||||Kruskal-Wallis|||||||.62
71012623|NCT04278846|141532574|SUPERIORITY|||||||0.94|||||||Kruskal-Wallis|||||||.94
71012624|NCT04278846|141532575|SUPERIORITY|||||||0.95|||||||Kruskal-Wallis|||||||.95
71012625|NCT04278846|141532576|SUPERIORITY|||||||0.54|||||||Kruskal-Wallis|||||||.54
71012626|NCT04278846|141532577|SUPERIORITY|||||||0.95|||||||Kruskal-Wallis|||||||.95
71012627|NCT04278846|141532578|SUPERIORITY|||||||0.96|||||||Kruskal-Wallis|||||||.96
71012628|NCT04278846|141532580|SUPERIORITY|||||||0.088|||||||Kruskal-Wallis|||||||.088
71012629|NCT04278846|141532581|SUPERIORITY|||||||0.42|||||||Kruskal-Wallis|||||||.42
71012630|NCT04278846|141532582|SUPERIORITY|||||||0.88|||||||Kruskal-Wallis|||||||.88
71012631|NCT04278846|141532584|SUPERIORITY|||||||0.12|||||||Kruskal-Wallis|||||||.12
71012632|NCT04278846|141532585|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||.96
71012633|NCT04278846|141532586|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||||||.76
71012634|NCT04278846|141532587|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||||||.88
71012635|NCT04278846|141532588|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||||||.37
71012636|NCT00635362|141532590|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35|TWO_SIDED||||||Fisher Exact|||||||0.35
71012637|NCT00635362|141532591|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED||||||Fisher Exact|||||||0.04
71012638|NCT00635362|141532592|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED|0.0|||||Fisher Exact|||||||1.000
71012639|NCT00635362|141532593|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|TWO_SIDED|0.0|||||Fisher Exact|||||||0.37
71012640|NCT00635362|141532594|SUPERIORITY_OR_OTHER_LEGACY|||||||1||0.0|||||Fisher Exact|||||||1.00
71012641|NCT01539512|141532603|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.18|||<|0.0001|TWO_SIDED|95.0|0.1|0.32|||Log Rank|P-value is from stratified log-rank test, adjusted for randomization stratification factors.||||0.32|0.10|< 0.0001
71012642|NCT01539512|141532606|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.28|||||TWO_SIDED|95.0|0.11|0.69||||||||0.69|0.11|
71012643|NCT01333501|141532638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.86|STANDARD_ERROR_OF_MEAN|2.7||0.494|TWO_SIDED|95.0|-3.51|7.23|||ANCOVA|||||7.23|-3.51|0.4940
71012644|NCT01333501|141532639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.97|STANDARD_ERROR_OF_MEAN|3.03||0.5183|TWO_SIDED|95.0|-4.06|7.99|||ANCOVA|||||7.99|-4.06|0.5183
71012645|NCT01333501|141532640|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6|STANDARD_ERROR_OF_MEAN|1.05||0.1334|TWO_SIDED|95.0|-3.69|0.5|||ANCOVA|||||0.50|-3.69|0.1334
71012646|NCT01333501|141532641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.73|STANDARD_ERROR_OF_MEAN|2.29||0.4501|TWO_SIDED|95.0|-6.27|2.81|||ANCOVA|||||2.81|-6.27|0.4501
71012647|NCT01333501|141532642|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|STANDARD_ERROR_OF_MEAN|2.53||0.8561|TWO_SIDED|95.0|-4.57|5.49|||ANCOVA|||||5.49|-4.57|0.8561
71012648|NCT01333501|141532643|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|2.53||0.8858|TWO_SIDED|95.0|-4.67|5.4|||ANCOVA|||||5.40|-4.67|0.8858
71012649|NCT01333501|141532644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.47||0.7119|TWO_SIDED|95.0|-0.76|1.11|||ANCOVA|||||1.11|-0.76|0.7119
71012650|NCT01333501|141532645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.42||0.9496|TWO_SIDED|95.0|-0.86|0.81|||ANCOVA|||||0.81|-0.86|0.9496
71012651|NCT01333501|141532646|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|1.18||0.8944|TWO_SIDED|95.0|-2.18|2.5|||ANCOVA|||||2.50|-2.18|0.8944
71012652|NCT01333501|141532647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25|STANDARD_ERROR_OF_MEAN|0.59||0.6757|TWO_SIDED|95.0|-1.42|0.92|||ANCOVA|||||0.92|-1.42|0.6757
71047519|NCT02408068|141604092|SUPERIORITY_OR_OTHER_LEGACY||Geometric LSmean ratio|108.33|||||TWO_SIDED|90.0|102.3|114.72|||ANOVA|||||114.72|102.30|
71047520|NCT02408068|141604093|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|2.25||||0.0005|TWO_SIDED|95.0|1.25|3.75|||Wilcoxon (Mann-Whitney)|||||3.75|1.25|0.0005
71047521|NCT02408068|141604094|SUPERIORITY_OR_OTHER_LEGACY||Geometric LSmean ratio|83.27|||||TWO_SIDED|90.0|75.58|91.74||||||||91.74|75.58|
71047522|NCT02408068|141604095|SUPERIORITY_OR_OTHER_LEGACY||Geometric LSmean ratio|118.83|||||TWO_SIDED|90.0|111.58|126.54||||||||126.54|111.58|
71012653|NCT01333501|141532648|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.16|STANDARD_ERROR_OF_MEAN|2.34||0.3585|TWO_SIDED|95.0|-6.82|2.5|||ANCOVA|||||2.50|-6.82|0.3585
70928729|NCT04800211|141353086|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-46.239||||0.7485|TWO_SIDED|95.0|-146.766|54.288|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||54.288|-146.766|0.7485
70941412|NCT02567227|141383495|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED||||||||Estimates with standard errors are from unadjusted linear mixed effect models.|Unadjusted linear mixed effects model was used to compare changes in stair climbing time pre and post intervention.||||
70941413|NCT02567227|141383496|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED||||||||Estimates with standard errors are from unadjusted linear mixed effect models.|Unadjusted linear mixed effects model was used to compare changes in activities of daily living pre and post intervention.||||
71012654|NCT01333501|141532649|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.24|STANDARD_ERROR_OF_MEAN|3.69||0.161|TWO_SIDED|95.0|-12.62|2.14|||ANCOVA|||||2.14|-12.62|0.1610
71012655|NCT00674440|141532659|OTHER||Sensitivity|93.0|||||TWO_SIDED|95.0|80.9|98.5||||||||98.5|80.9|
71012656|NCT00674440|141532659|OTHER||Specifity|88.5|||||TWO_SIDED|95.0|76.6|95.6||||||||95.6|76.6|
71047523|NCT02408068|141604096|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|3.5||||0.0014|TWO_SIDED|95.0|2.25|4.38|||Wilcoxon (Mann-Whitney)|||||4.38|2.25|0.0014
71047524|NCT02623348|141604102|SUPERIORITY||||||<|0.01||||||Threshold for significance: \<0.05|linear mixed modeling|||||||<0.01
71047525|NCT02666352|141604112|OTHER||Geometric least-squares mean ratio|1.43|||||TWO_SIDED|90.0|0.89|2.31||||||||2.31|0.89|
71103908|NCT02546323|141715205|OTHER||Least squares mean difference|-33.78|STANDARD_ERROR_OF_MEAN|1.529|<|0.001|TWO_SIDED|95.0|-36.78|-30.78|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Non-HDL-C||-30.78|-36.78|<0.001
71012657|NCT04095039|141532676|SUPERIORITY|||||||0.077||||||p-value is based on a sample that is less than 10% of the planned sample size (planned n=4,000)|Finkelstein-Schoenfeld method|||Primary outcome is for the individually randomized cohort since DSMB had concerns about selection bias for the cluster-randomized population due to differences in baseline characteristics that leaned towards the arm objectives.||||0.077
71012658|NCT01728194|141532709|OTHER||||||<|0.025|||||||Mixed Models Analysis|||||||< 0.025
71047526|NCT02666352|141604112|OTHER||Geometric least-squares mean ratio|2.15|||||TWO_SIDED|90.0|1.33|3.47||||||||3.47|1.33|
71047527|NCT02666352|141604113|OTHER||Geometric least-squares mean ratio|1.43|||||TWO_SIDED|90.0|0.88|2.31||||||||2.31|0.88|
71047528|NCT02666352|141604113|OTHER||Geometric least-squares mean ratio|2.15||||||90.0|1.33|3.48||||||||3.48|1.33|
71012659|NCT01728194|141532710|OTHER||||||<|0.025|||||||Mixed Models Analysis|||||||<0.025
71012660|NCT01590810|141532739|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|1.15||0.503|TWO_SIDED|95.0|-1.59|3.15|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.15|-1.59|0.503
71012661|NCT01590810|141532739|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-2.86|-1.55|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-1.55|-2.86|<0.0001
71012662|NCT01590810|141532739|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.23|STANDARD_ERROR_OF_MEAN|0.92|<|0.0001|TWO_SIDED|95.0|-10.13|-6.34|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.34|-10.13|<0.0001
71012663|NCT01590810|141532739|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.84|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|-9.1|-4.58|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-4.58|-9.10|<0.0001
71012664|NCT01590810|141532739|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.41|STANDARD_ERROR_OF_MEAN|1.21|<|0.0001|TWO_SIDED|95.0|-12.89|-7.92|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-7.92|-12.89|<0.0001
71012665|NCT01590810|141532740|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.89|STANDARD_ERROR_OF_MEAN|1.4||0.052|TWO_SIDED|95.0|-5.79|0.02|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||0.02|-5.79|0.052
71047529|NCT02666352|141604114|OTHER||Geometric least-squares mean ratio|1.43|||||TWO_SIDED|90.0|0.89|2.31||||||||2.31|0.89|
71047530|NCT02666352|141604114|OTHER||Geometric least-squares mean ratio|2.15|||||TWO_SIDED|90.0|1.33|3.47||||||||3.47|1.33|
71047531|NCT02666352|141604115|OTHER||Geometric least-squares mean ratio|1.32|||||TWO_SIDED|90.0|0.81|2.15||||||||2.15|0.81|
71047532|NCT02666352|141604115|OTHER||Geometric least-squares mean ratio|1.81|||||TWO_SIDED|90.0|1.11|2.94||||||||2.94|1.11|
71047533|NCT02666352|141604121|OTHER||Geometric least-squares mean ratio|0.8|||||TWO_SIDED|90.0|0.58|1.1||||||||1.10|0.58|
71047534|NCT02666352|141604121|OTHER||Geometric least-squares mean ratio|0.84|||||TWO_SIDED|90.0|0.61|1.16||||||||1.16|0.61|
71047535|NCT02666352|141604122|OTHER||Geometric least-squares mean ratio|0.8|||||TWO_SIDED|90.0|0.58|1.11||||||||1.11|0.58|
71047536|NCT02666352|141604122|OTHER||Geometric least-squares mean ratio|0.86||||||90.0|0.62|1.18||||||||1.18|0.62|
71047537|NCT02666352|141604123|OTHER||Geometric least-squares mean ratio|0.77|||||TWO_SIDED|90.0|0.57|1.05||||||||1.05|0.57|
71103909|NCT02546323|141715205|OTHER||Least squares mean difference|-33.93|STANDARD_ERROR_OF_MEAN|1.836|<|0.001|TWO_SIDED|95.0|-37.54|-30.32|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Non-HDL-C/HDL-C ratio||-30.32|-37.54|<0.001
71103910|NCT01506726|141715251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94||||0.23|TWO_SIDED|95.0|-2.08|0.2|||Wilcoxon (Mann-Whitney)|Wilcoxon two sample test||||0.20|-2.08|0.230
71103911|NCT01506726|141715252|SUPERIORITY_OR_OTHER|||||||0.347|TWO_SIDED||||||t-test, 2 sided|||||||0.347
71103912|NCT01506726|141715253|SUPERIORITY_OR_OTHER|||||||0.857|TWO_SIDED|||||Correlation between change in IL-6 and change in hemoglobin in the salsalate group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.857
71012666|NCT01590810|141532740|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.46|STANDARD_ERROR_OF_MEAN|1.95||0.01|TWO_SIDED|95.0|-9.49|-1.43|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-1.43|-9.49|0.010
71012667|NCT01590810|141532740|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.49|STANDARD_ERROR_OF_MEAN|2.27|<|0.001|TWO_SIDED|95.0|-14.2|-4.79|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-4.79|-14.20|<0.001
71103913|NCT01506726|141715253|SUPERIORITY_OR_OTHER|||||||0.706|TWO_SIDED|||||Correlation between change in IL-6 and change in hemoglobin in the placebo group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.706
71103914|NCT01506726|141715253|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED|||||Correlation between change in TNF and change in hemoglobin in the salsalate group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.014
71103915|NCT01506726|141715253|SUPERIORITY_OR_OTHER|||||||0.136|TWO_SIDED|||||Correlation between change in TNF and change in hemoglobin in the placebo group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.136
71103916|NCT01506726|141715253|SUPERIORITY_OR_OTHER|||||||0.803|TWO_SIDED|||||Correlation between change in CRP and change in hemoglobin in the salsalate group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.803
71012668|NCT01590810|141532740|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.02|STANDARD_ERROR_OF_MEAN|2.17|<|0.0001|TWO_SIDED|95.0|-16.51|-7.52|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-7.52|-16.51|<0.0001
71012669|NCT01590810|141532740|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.73|STANDARD_ERROR_OF_MEAN|1.55|<|0.0001|TWO_SIDED|95.0|-12.93|-6.53|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.53|-12.93|<0.0001
71012670|NCT01590810|141532741|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|5.61||0.48|TWO_SIDED|95.0|-16.44|8.25|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||8.25|-16.44|0.480
71012671|NCT01590810|141532741|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.79|STANDARD_ERROR_OF_MEAN|5.72||0.086|TWO_SIDED|95.0|-23.37|1.79|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.79|-23.37|0.086
71103917|NCT01506726|141715253|SUPERIORITY_OR_OTHER|||||||0.894|TWO_SIDED|||||Correlation between change in CRP and change in hemoglobin in the placebo group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.894
71103918|NCT01506726|141715254|SUPERIORITY_OR_OTHER|||||||0.143|TWO_SIDED|||||P value comparing change in IL6 between treatment groups.|t-test, 2 sided|||||||0.143
71012672|NCT01590810|141532741|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.51|STANDARD_ERROR_OF_MEAN|5.15||0.006|TWO_SIDED|95.0|-28.85|-6.18|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.18|-28.85|0.006
71103919|NCT01506726|141715254|SUPERIORITY_OR_OTHER|||||||0.257|TWO_SIDED|||||P value comparing the change in TNF between treatment groups.|t-test, 2 sided|||||||0.257
71012673|NCT01590810|141532742|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.21|STANDARD_ERROR_OF_MEAN|1.74|<|0.0001|TWO_SIDED|95.0|-16.84|-9.59|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-9.59|-16.84|<0.0001
71012674|NCT01590810|141532742|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.2|STANDARD_ERROR_OF_MEAN|1.8|<|0.0001|TWO_SIDED|95.0|-13.94|-6.45|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.45|-13.94|<0.0001
71012675|NCT01590810|141532742|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.82|STANDARD_ERROR_OF_MEAN|1.74|<|0.0001|TWO_SIDED|95.0|-16.45|-9.19|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-9.19|-16.45|<0.0001
71103920|NCT01506726|141715255|SUPERIORITY_OR_OTHER|||||||0.535|TWO_SIDED|||||P-value comparing the change in EPO between treatment groups.|t-test, 2 sided|||||||0.535
71103921|NCT01506726|141715256|SUPERIORITY_OR_OTHER|||||||0.232|TWO_SIDED||||||t-test, 2 sided|||||||0.232
71103922|NCT01506726|141715257|SUPERIORITY_OR_OTHER|||||||0.076|TWO_SIDED||||||t-test, 2 sided|||||||0.076
71103923|NCT01506726|141715258|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Chi-squared|||||||>0.999
71103924|NCT01506726|141715259|SUPERIORITY_OR_OTHER|||||||0.187|TWO_SIDED||||||t-test, 2 sided|||||||0.187
71103925|NCT01506726|141715260|SUPERIORITY_OR_OTHER|||||||0.193|TWO_SIDED||||||t-test, 2 sided|||||||0.193
71103926|NCT01506726|141715261|SUPERIORITY_OR_OTHER|||||||0.619|TWO_SIDED||||||t-test, 2 sided|||||||0.619
71103927|NCT01506726|141715262|SUPERIORITY_OR_OTHER|||||||0.642|TWO_SIDED||||||t-test, 2 sided|||||||0.642
71103928|NCT01506726|141715263|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED||||||t-test, 2 sided|||||||0.42
71103929|NCT01506726|141715264|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Chi-squared|||||||>0.999
71103930|NCT01506726|141715265|SUPERIORITY_OR_OTHER|||||||0.375|TWO_SIDED||||||Chi-squared|||||||0.375
71103931|NCT01506726|141715267|SUPERIORITY_OR_OTHER|||||||0.398|||||||t-test, 2 sided|||||||0.398
71103932|NCT01506726|141715268|SUPERIORITY_OR_OTHER|||||||0.412|||||||t-test, 2 sided|||||||0.412
71103933|NCT03863574|141715269|OTHER|Proof of Concept||||||0.7689|||||||t-test, 2 sided|||||||0.7689
71103934|NCT03863574|141715269|OTHER|Proof-of-concept||||||0.6007|||||||t-test, 2 sided|||||||0.6007
71103935|NCT03863574|141715270|OTHER|||||||0.5238|||||||Fisher Exact|||||||0.5238
71103936|NCT03863574|141715270|OTHER||||||>|0.9999|||||||Fisher Exact|||||||>0.9999
71103937|NCT03863574|141715271|OTHER|Proof-of-concept||||||0.0476|||||||Fisher Exact|||||||0.0476
71103938|NCT03863574|141715271|OTHER|Proof-of-concept||||||0.0333|||||||Fisher Exact|||||||0.0333
71103939|NCT03863574|141715272|OTHER|Proof-of-concept||||||0.6845|||||||t-test, 2 sided|||Outcome Variable: Steatosis||||0.6845
71103940|NCT03863574|141715272|OTHER|Proof-of-concept||||||0.4625|||||||t-test, 2 sided|||Outcome Variable: Steatosis||||0.4625
71103941|NCT03863574|141715272|OTHER|Proof-of-concept||||||0.1705|||||||t-test, 2 sided|||Outcome Variable: Lobular Inflammation||||0.1705
71103942|NCT03863574|141715272|OTHER|Proof-of-concept||||||0.3122|||||||t-test, 2 sided|||Outcome variable: Lobular Inflammation||||0.3122
71103943|NCT03863574|141715272|OTHER|Proof-of-concept||||||0.1705|||||||t-test, 2 sided|||Outcome Variable: Hepatocyte Ballooning||||0.1705
71103944|NCT03863574|141715272|OTHER|Proof-of-concept||||||0.3877|||||||t-test, 2 sided|||Outcome Variable: Hepatocyte Ballooning||||0.3877
71103945|NCT03863574|141715273|OTHER|Proof-of-concept||||||0.1705|||||||t-test, 2 sided|||||||0.1705
71103946|NCT03863574|141715273|OTHER|Proof-of-concept||||||0.174|||||||t-test, 2 sided|||||||0.1740
70928730|NCT04800211|141353086|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-36.559||||0.9578|TWO_SIDED|95.0|-169.77|96.653|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||96.653|-169.770|0.9578
70928731|NCT04800211|141353086|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-40.725||||0.3635|TWO_SIDED|95.0|-129.208|47.757|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||47.757|-129.208|0.3635
71012676|NCT01590810|141532742|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.84|STANDARD_ERROR_OF_MEAN|1.75|<|0.0001|TWO_SIDED|95.0|-16.49|-9.19|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-9.19|-16.49|<0.0001
71012677|NCT01590810|141532743|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.31|STANDARD_ERROR_OF_MEAN|1.18||0.061|TWO_SIDED|95.0|-4.73|0.11|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||0.11|-4.73|0.061
71012678|NCT01590810|141532743|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.23|STANDARD_ERROR_OF_MEAN|0.86||0.016|TWO_SIDED|95.0|-4.0|-0.45|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.45|-4.00|0.016
71012679|NCT01590810|141532743|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.62|STANDARD_ERROR_OF_MEAN|1.36|<|0.0001|TWO_SIDED|95.0|-14.42|-8.82|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-8.82|-14.42|<0.0001
71012680|NCT01590810|141532743|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.15|STANDARD_ERROR_OF_MEAN|1.55|<|0.0001|TWO_SIDED|95.0|-11.34|-4.96|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-4.96|-11.34|<0.0001
71012681|NCT01590810|141532743|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.78|STANDARD_ERROR_OF_MEAN|1.96|<|0.0001|TWO_SIDED|95.0|-20.81|-12.75|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-12.75|-20.81|<0.0001
71012682|NCT01590810|141532744|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.95|STANDARD_ERROR_OF_MEAN|1.26||0.029|TWO_SIDED|95.0|-5.56|-0.34|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.34|-5.56|0.029
71012683|NCT01590810|141532744|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.76|STANDARD_ERROR_OF_MEAN|2.19||0.005|TWO_SIDED|95.0|-11.29|-2.22|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.22|-11.29|0.005
71012684|NCT01590810|141532744|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.48|STANDARD_ERROR_OF_MEAN|3.16|<|0.001|TWO_SIDED|95.0|-20.03|-6.93|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.93|-20.03|<0.001
71103947|NCT03863574|141715274|OTHER|Proof-of-concept||||||0.8019|||||||t-test, 2 sided|||Outcome variable: Alanine Aminotransferase||||0.8019
71103948|NCT03863574|141715274|OTHER|Proof-of-concept||||||0.5396|||||||t-test, 2 sided|||Outcome Variable: Alanine Aminotransferase||||0.5396
71012685|NCT01590810|141532744|SUPERIORITY_OR_OTHER||LS Mean Difference|-18.33|STANDARD_ERROR_OF_MEAN|1.76|<|0.0001|TWO_SIDED|95.0|-21.98|-14.68|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-14.68|-21.98|<0.0001
71012686|NCT01590810|141532744|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.24|STANDARD_ERROR_OF_MEAN|1.96|<|0.0001|TWO_SIDED|95.0|-20.29|-12.19|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-12.19|-20.29|<0.0001
71012687|NCT01590810|141532745|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.59|STANDARD_ERROR_OF_MEAN|2.51||0.539|TWO_SIDED|95.0|-7.12|3.93|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.93|-7.12|0.539
71012688|NCT01590810|141532745|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.36|STANDARD_ERROR_OF_MEAN|3.12||0.113|TWO_SIDED|95.0|-12.23|1.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.50|-12.23|0.113
71012689|NCT01590810|141532745|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.3|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|-19.69|-8.91|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-8.91|-19.69|<0.001
71012690|NCT01590810|141532746|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.36|STANDARD_ERROR_OF_MEAN|1.56|<|0.0001|TWO_SIDED|95.0|-15.62|-9.11|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-9.11|-15.62|<0.0001
71103949|NCT03863574|141715274|OTHER|Proof-of-concept||||||0.774|||||||t-test, 2 sided|||Outcome Variable: Aspartate Aminotransferase||||0.7740
71103950|NCT03863574|141715274|OTHER|Proof-of-concept||||||0.9221|||||||t-test, 2 sided|||Outcome Variable: Aspartate Aminotransferase||||0.9221
71103951|NCT03863574|141715274|OTHER|Proof-of-concept||||||0.003|||||||t-test, 2 sided|||Outcome Variable: Alkaline Phosphatase||||0.0030
71103952|NCT03863574|141715274|OTHER|Proof-of-concept||||||0.0177|||||||t-test, 2 sided|||Outcome Variable: Alkaline Phosphatase||||0.0177
71012691|NCT01590810|141532746|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.58|STANDARD_ERROR_OF_MEAN|1.51|<|0.0001|TWO_SIDED|95.0|-13.74|-7.42|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-7.42|-13.74|<0.0001
71012692|NCT01590810|141532746|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.63|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|-16.12|-11.13|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-11.13|-16.12|<0.0001
71012693|NCT01590810|141532746|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.96|STANDARD_ERROR_OF_MEAN|1.38|<|0.0001|TWO_SIDED|95.0|-15.85|-10.08|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-10.08|-15.85|<0.0001
71012694|NCT01590810|141532747|SUPERIORITY_OR_OTHER||LS Mean Difference|1.05|STANDARD_ERROR_OF_MEAN|0.75||0.175|TWO_SIDED|95.0|-0.5|2.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.60|-0.50|0.175
71012695|NCT01590810|141532747|SUPERIORITY_OR_OTHER||LS Mean Difference|2.18|STANDARD_ERROR_OF_MEAN|1.18||0.076|TWO_SIDED|95.0|-0.25|4.61|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||4.61|-0.25|0.076
71012696|NCT01590810|141532747|SUPERIORITY_OR_OTHER||LS Mean Difference|2.18|STANDARD_ERROR_OF_MEAN|0.55||0.001|TWO_SIDED|95.0|1.04|3.32|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.32|1.04|0.001
71012697|NCT01590810|141532747|SUPERIORITY_OR_OTHER||LS Mean Difference|5.64|STANDARD_ERROR_OF_MEAN|1.22|<|0.0001|TWO_SIDED|95.0|3.14|8.15|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||8.15|3.14|<0.0001
71012698|NCT01590810|141532747|SUPERIORITY_OR_OTHER||LS Mean Difference|2.15|STANDARD_ERROR_OF_MEAN|0.74||0.008|TWO_SIDED|95.0|0.63|3.67|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.67|0.63|0.008
71012699|NCT01590810|141532748|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.39||0.557|TWO_SIDED|95.0|-3.7|2.05|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.05|-3.70|0.557
71012700|NCT01590810|141532748|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.48|STANDARD_ERROR_OF_MEAN|1.05||0.175|TWO_SIDED|95.0|-3.65|0.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||0.70|-3.65|0.175
71012701|NCT01590810|141532748|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|1.52||0.951|TWO_SIDED|95.0|-3.04|3.23|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.23|-3.04|0.951
71012702|NCT01590810|141532748|SUPERIORITY_OR_OTHER||LS Mean Difference|2.61|STANDARD_ERROR_OF_MEAN|0.61|<|0.001|TWO_SIDED|95.0|1.34|3.88|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.88|1.34|<0.001
71012703|NCT01590810|141532748|SUPERIORITY_OR_OTHER||LS Mean Difference|4.62|STANDARD_ERROR_OF_MEAN|0.78|<|0.0001|TWO_SIDED|95.0|3.0|6.24|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||6.24|3.00|<0.0001
71012704|NCT01590810|141532749|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.45|STANDARD_ERROR_OF_MEAN|1.16||0.241|TWO_SIDED|95.0|-4.01|1.12|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.12|-4.01|0.241
71012705|NCT01590810|141532749|SUPERIORITY_OR_OTHER||LS Mean Difference|0.92|STANDARD_ERROR_OF_MEAN|2.07||0.664|TWO_SIDED|95.0|-3.63|5.48|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||5.48|-3.63|0.664
71012706|NCT01590810|141532749|SUPERIORITY_OR_OTHER||LS Mean Difference|3.65|STANDARD_ERROR_OF_MEAN|2.13||0.114|TWO_SIDED|95.0|-1.03|8.33|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||8.33|-1.03|0.114
71012707|NCT01590810|141532750|SUPERIORITY_OR_OTHER||LS Mean Difference|4.42|STANDARD_ERROR_OF_MEAN|4.98||0.385|TWO_SIDED|95.0|-5.96|14.81|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||14.81|-5.96|0.385
71012708|NCT01590810|141532750|SUPERIORITY_OR_OTHER||LS Mean Difference|4.58|STANDARD_ERROR_OF_MEAN|5.15||0.385|TWO_SIDED|95.0|-6.16|15.32|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||15.32|-6.16|0.385
71012709|NCT01590810|141532750|SUPERIORITY_OR_OTHER||LS Mean Difference|5.15|STANDARD_ERROR_OF_MEAN|4.6||0.276|TWO_SIDED|95.0|-4.44|14.74|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||14.74|-4.44|0.276
71012710|NCT01590810|141532750|SUPERIORITY_OR_OTHER||LS Mean Difference|9.5|STANDARD_ERROR_OF_MEAN|4.94||0.069|TWO_SIDED|95.0|-0.81|19.81|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||19.81|-0.81|0.069
71012711|NCT01590810|141532751|SUPERIORITY_OR_OTHER||LS Mean Difference|0.97|STANDARD_ERROR_OF_MEAN|1.09||0.383|TWO_SIDED|95.0|-1.28|3.22|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.22|-1.28|0.383
71012712|NCT01590810|141532751|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.75|STANDARD_ERROR_OF_MEAN|0.51||0.002|TWO_SIDED|95.0|-2.79|-0.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.70|-2.79|0.002
71012713|NCT01590810|141532751|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.11|STANDARD_ERROR_OF_MEAN|0.96|<|0.0001|TWO_SIDED|95.0|-10.08|-6.14|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.14|-10.08|<0.0001
71047538|NCT02666352|141604123|OTHER||Geometric least-squares mean ratio|0.73|||||TWO_SIDED|90.0|0.54|0.99||||||||0.99|0.54|
71047539|NCT02666352|141604124|OTHER||Geometric least-squares mean ratio|0.83|||||TWO_SIDED|90.0|0.61|1.13||||||||1.13|0.61|
71047540|NCT02666352|141604124|OTHER||Geometric least-squares mean ratio|0.75|||||TWO_SIDED|90.0|0.55|1.01||||||||1.01|0.55|
71047541|NCT02666352|141604125|OTHER||Geometric least-squares mean ratio|0.83|||||TWO_SIDED|90.0|0.6|1.15||||||||1.15|0.60|
71047542|NCT02666352|141604125|OTHER||Geometric least-squares mean ratio|0.82|||||TWO_SIDED|90.0|0.59|1.13||||||||1.13|0.59|
71047543|NCT02666352|141604129|OTHER||Geometric least-squares mean ratio|0.68|||||TWO_SIDED|90.0|0.52|0.9||||||||0.90|0.52|
71047544|NCT02666352|141604129|OTHER||Geometric least-squares mean ratio|0.66|||||TWO_SIDED|90.0|0.5|0.86||||||||0.86|0.50|
71047545|NCT02666352|141604130|OTHER||Geometric least-squares mean ratio|0.64|||||TWO_SIDED|90.0|0.48|0.86||||||||0.86|0.48|
71047546|NCT02666352|141604130|OTHER||Geometric least-squares mean ratio|0.61||||||90.0|0.46|0.82||||||||0.82|0.46|
71047547|NCT02666352|141604131|OTHER||Geometric least-squares mean ratio|0.79|||||TWO_SIDED|90.0|0.62|1.01||||||||1.01|0.62|
71047548|NCT02666352|141604131|OTHER||Geometric least-squares mean ratio|0.8|||||TWO_SIDED|90.0|0.63|1.02||||||||1.02|0.63|
71047549|NCT02666352|141604132|OTHER||Geometric least-squares mean ratio|0.8|||||TWO_SIDED|90.0|0.61|1.05||||||||1.05|0.61|
71047550|NCT02666352|141604132|OTHER||Geometric least-squares mean ratio|0.78|||||TWO_SIDED|90.0|0.6|1.03||||||||1.03|0.60|
71047551|NCT02666352|141604133|OTHER||Geometric least-squares mean ratio|0.71|||||TWO_SIDED|90.0|0.57|0.89||||||||0.89|0.57|
71047552|NCT02666352|141604133|OTHER||Geometric least-squares mean ratio|0.73|||||TWO_SIDED|90.0|0.58|0.91||||||||0.91|0.58|
71047553|NCT02666352|141604136|OTHER||Geometric least-squares mean ratio (GMR)|1.16|||||TWO_SIDED|90.0|0.85|1.58||||||||1.58|0.85|
71012714|NCT01590810|141532751|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|1.58|<|0.001|TWO_SIDED|95.0|-9.74|-3.25|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.25|-9.74|<0.001
71103953|NCT03863574|141715274|OTHER|Proof-of-concept||||||0.1399|||||||t-test, 2 sided|||Outcome Variable: Gamma Glutamyl Transferase||||0.1399
71103954|NCT03863574|141715274|OTHER|Proof-of-concept||||||0.2384|||||||t-test, 2 sided|||Outcome Variable: Gamma Glutamyl Transferase||||0.2384
71103955|NCT03863574|141715275|OTHER|Proof-of-concept||||||0.2218|||||||t-test, 2 sided|||Outcome Variable: Albumin||||0.2218
71103956|NCT03863574|141715275|OTHER|Proof-of-Concept||||||0.1483|||||||t-test, 2 sided|||Outcome Variable: Albumin||||0.1483
70941414|NCT02567227|141383497|SUPERIORITY||Mean Difference (Net)|0.26|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-0.4|0.93|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in depressive symptoms measured using the GDS pre and post intervention.||0.93|-0.40|
71012715|NCT01590810|141532751|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.31|STANDARD_ERROR_OF_MEAN|1.23|<|0.0001|TWO_SIDED|95.0|-12.84|-7.78|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-7.78|-12.84|<0.0001
71012716|NCT01590810|141532752|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.07|STANDARD_ERROR_OF_MEAN|1.62||0.216|TWO_SIDED|95.0|-5.43|1.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.30|-5.43|0.216
71012717|NCT01590810|141532752|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|2.27||0.046|TWO_SIDED|95.0|-9.51|-0.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.10|-9.51|0.046
71012718|NCT01590810|141532752|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.93|STANDARD_ERROR_OF_MEAN|2.5||0.002|TWO_SIDED|95.0|-14.1|-3.76|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.76|-14.10|0.002
71012719|NCT01590810|141532752|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.16|STANDARD_ERROR_OF_MEAN|2.65|<|0.001|TWO_SIDED|95.0|-16.64|-5.68|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.68|-16.64|<0.001
71012720|NCT01590810|141532752|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.25|STANDARD_ERROR_OF_MEAN|1.67|<|0.0001|TWO_SIDED|95.0|-12.7|-5.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.80|-12.70|<0.0001
71103957|NCT03863574|141715275|OTHER|Proof-of-concept||||||0.0839|||||||t-test, 2 sided|||Outcome Variable: Total Protein||||0.0839
71103958|NCT03863574|141715275|OTHER|Proof-of-concept||||||0.2895|||||||t-test, 2 sided|||Outcome Variable: Total Protein||||0.2895
71012721|NCT01590810|141532753|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.27|STANDARD_ERROR_OF_MEAN|4.65||0.635|TWO_SIDED|95.0|-12.5|7.96|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.96|-12.50|0.635
71012722|NCT01590810|141532753|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.18|STANDARD_ERROR_OF_MEAN|5.18||0.143|TWO_SIDED|95.0|-19.58|3.22|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.22|-19.58|0.143
71103959|NCT03863574|141715276|OTHER|Proof-of-concept||||||0.6808|||||||t-test, 2 sided|||Outcome Variable: Direct Bilirubin||||0.6808
71103960|NCT03863574|141715276|OTHER|Proof-of-concept||||||0.5351|||||||t-test, 2 sided|||Outcome Variable: Direct Bilirubin||||0.5351
71103961|NCT03863574|141715277|OTHER|Proof-of-concept||||||0.2329|||||||t-test, 2 sided|||Outcome Variable: Triglyceride||||0.2329
71103962|NCT03863574|141715277|OTHER|Proof-of-concept||||||0.7211|||||||t-test, 2 sided|||Outcome Variable: Triglyceride||||0.7211
71103963|NCT03863574|141715277|OTHER|Proof-of-concept||||||0.652|||||||t-test, 2 sided|||Outcome Variables: Total Cholesterol||||0.6520
71103964|NCT03863574|141715277|OTHER|Proof-of-concept||||||0.4302|||||||t-test, 2 sided|||Outcome Variable: Total Cholesterol||||0.4302
71012723|NCT01590810|141532753|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.51|STANDARD_ERROR_OF_MEAN|4.32||0.004|TWO_SIDED|95.0|-25.01|-6.01|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.01|-25.01|0.004
71012724|NCT01590810|141532754|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.84|STANDARD_ERROR_OF_MEAN|1.42|<|0.0001|TWO_SIDED|95.0|-13.79|-7.89|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-7.89|-13.79|<0.0001
71012725|NCT01590810|141532754|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.55|STANDARD_ERROR_OF_MEAN|1.26|<|0.0001|TWO_SIDED|95.0|-11.18|-5.91|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.91|-11.18|<0.0001
71012726|NCT01590810|141532754|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.64|STANDARD_ERROR_OF_MEAN|1.34|<|0.0001|TWO_SIDED|95.0|-13.44|-7.84|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-7.84|-13.44|<0.0001
71012727|NCT01590810|141532754|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.13|STANDARD_ERROR_OF_MEAN|1.36|<|0.0001|TWO_SIDED|95.0|-13.97|-8.29|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-8.29|-13.97|<0.0001
71012728|NCT01590810|141532755|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|1.19||0.547|TWO_SIDED|95.0|-3.19|1.73|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.73|-3.19|0.547
71012729|NCT01590810|141532755|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.53||0.004|TWO_SIDED|95.0|-2.79|-0.62|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.62|-2.79|0.004
71012730|NCT01590810|141532755|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.59|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|TWO_SIDED|95.0|-6.23|-2.94|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.94|-6.23|<0.0001
71103965|NCT03863574|141715277|OTHER|Proof-of-concept||||||0.9432|||||||t-test, 2 sided|||Outcome Variable: High-density Lipoprotein||||0.9432
71103966|NCT03863574|141715277|OTHER|Proof-of-concept||||||0.2133|||||||t-test, 2 sided|||Outcome Variable: High-density Lipoprotein||||0.2133
71103967|NCT03863574|141715277|OTHER|Proof-of-concept||||||0.2446|||||||t-test, 2 sided|||Outcome Variable: Low-density lipoprotein||||0.2446
71103968|NCT03863574|141715277|OTHER|Proof-of-concept||||||0.7075|||||||t-test, 2 sided|||Outcome Variable: Low-density lipoprotein||||0.7075
71103969|NCT03863574|141715277|OTHER|Proof-of-concept||||||0.2195|||||||t-test, 2 sided|||Outcome Variable: Very low-density lipoprotein||||0.2195
71047554|NCT02666352|141604136|OTHER||Geometric least-squares mean ratio|1.36|||||TWO_SIDED|90.0|1.0|1.85||||||||1.85|1.00|
71047555|NCT02666352|141604137|OTHER||Geometric least-squares mean ratio|1.24|||||TWO_SIDED|90.0|0.91|1.68||||||||1.68|0.91|
71047556|NCT02666352|141604137|OTHER||Geometric least-squares mean ratio|1.58||||||90.0|1.17|2.14||||||||2.14|1.17|
71012731|NCT01590810|141532755|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.37|STANDARD_ERROR_OF_MEAN|0.78|<|0.001|TWO_SIDED|95.0|-4.98|-1.76|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-1.76|-4.98|<0.001
71012732|NCT01590810|141532755|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.92|STANDARD_ERROR_OF_MEAN|1.13|<|0.0001|TWO_SIDED|95.0|-8.24|-3.59|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.59|-8.24|<0.0001
71047557|NCT02666352|141604138|OTHER||Geometric least-squares mean ratio|0.89|||||TWO_SIDED|90.0|0.6|1.33||||||||1.33|0.60|
71047558|NCT02666352|141604138|OTHER||Geometric least-squares mean ratio|0.9|||||TWO_SIDED|90.0|0.6|1.34||||||||1.34|0.60|
71012733|NCT01590810|141532756|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.43|STANDARD_ERROR_OF_MEAN|1.33||0.017|TWO_SIDED|95.0|-6.19|-0.67|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.67|-6.19|0.017
71012734|NCT01590810|141532756|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.64|STANDARD_ERROR_OF_MEAN|1.35|<|0.001|TWO_SIDED|95.0|-8.43|-2.84|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.84|-8.43|<0.001
71012735|NCT01590810|141532756|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.99|STANDARD_ERROR_OF_MEAN|1.91||0.005|TWO_SIDED|95.0|-9.94|-2.04|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.04|-9.94|0.005
71012736|NCT01590810|141532756|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.33|STANDARD_ERROR_OF_MEAN|1.73|<|0.001|TWO_SIDED|95.0|-10.9|-3.76|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.76|-10.90|<0.001
71047559|NCT02666352|141604139|OTHER||Geometric least-squares mean ratio|0.77|||||TWO_SIDED|90.0|0.45|1.3||||||||1.30|0.45|
71012737|NCT01590810|141532756|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.22|STANDARD_ERROR_OF_MEAN|1.22|<|0.001|TWO_SIDED|95.0|-7.76|-2.69|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.69|-7.76|<0.001
71012738|NCT01590810|141532757|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.93|STANDARD_ERROR_OF_MEAN|6.52||0.311|TWO_SIDED|95.0|-21.27|7.42|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.42|-21.27|0.311
71012739|NCT01590810|141532757|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.87|STANDARD_ERROR_OF_MEAN|6.62||0.078|TWO_SIDED|95.0|-27.44|1.69|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.69|-27.44|0.078
71012740|NCT01590810|141532757|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.03|STANDARD_ERROR_OF_MEAN|6.29||0.027|TWO_SIDED|95.0|-29.87|-2.19|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.19|-29.87|0.027
71047560|NCT02666352|141604139|OTHER||Geometric least-squares mean ratio|0.68|||||TWO_SIDED|90.0|0.4|1.14||||||||1.14|0.40|
71047561|NCT02666352|141604140|OTHER||Geometric least-squares mean ratio|1.2|||||TWO_SIDED|90.0|0.9|1.6||||||||1.60|0.90|
71047562|NCT02666352|141604140|OTHER||Geometric least-squares mean ratio|1.41|||||TWO_SIDED|90.0|1.06|1.87||||||||1.87|1.06|
71047563|NCT00706381|141604153|SUPERIORITY||Percent change from placebo|7.87|STANDARD_DEVIATION|9.2||0.0001|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||0.0001
71047564|NCT00706381|141604153|SUPERIORITY||Percent change from placebo|9.25|STANDARD_DEVIATION|8.3|<|0.0001|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||<0.0001
71047565|NCT00706381|141604153|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_DEVIATION|6.2||0.89|TWO_SIDED||||||Percent change from placebo|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||0.89
71047566|NCT00706381|141604153|SUPERIORITY||Percent change from placebo|-0.3|STANDARD_DEVIATION|7.2||0.41|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||0.41
71047567|NCT00706381|141604154|SUPERIORITY||Percent change from placebo|40.0|STANDARD_DEVIATION|72.8||0.096|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||0.096
71047568|NCT00706381|141604154|SUPERIORITY||Percent change from placebo|260.4|STANDARD_DEVIATION|191.7|<|0.0001|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||<0.0001
71047569|NCT00706381|141604154|SUPERIORITY||Percent change from placebo|16.4|STANDARD_DEVIATION|56.3||0.83|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||0.83
71047570|NCT00706381|141604154|SUPERIORITY||Percent change from placebo|125.7|STANDARD_DEVIATION|92.2|<|0.0001|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||<0.0001
71047571|NCT01640873|141604173|OTHER||Least Squares Mean Difference|-8.5||||0.356|TWO_SIDED|90.0|-47.4|30.4||The posterior probability that the reduction in FPG is ≥ 20 mg/dL is 0.06, and hence, the FPG hypothesis was not met.|Constrained longitudinal data analysis|||||30.4|-47.4|0.356
71047572|NCT01640873|141604175|OTHER||Geometric Mean Ratio|1.05||||0.2714|TWO_SIDED|90.0|0.92|1.19||The posterior probability that the reduction in 24h-WMG is ≥ 20 mg/dL is \< 0.01, and hence, the 24h- WMG hypothesis was not met.|Constrained longitudinal data analysis|||||1.19|0.92|0.2714
71047573|NCT01640873|141604176|OTHER|Day 1|Geometric Mean Ratio|1.22||||0.06|TWO_SIDED|95.0|0.99|1.55|||ANOVA|Placebo-corrected (MK-8655 / placebo)||||1.55|0.99|0.060
71047574|NCT01640873|141604176|OTHER|Day 3|Geometric mean Ratio|1.2||||0.065|TWO_SIDED|95.0|0.98|1.47|||ANOVA|Placebo-corrected (MK-8655 / placebo)||||1.47|0.98|0.065
71047575|NCT01640873|141604176|OTHER|Day 16|Geometric Mean Ratio|1.1||||0.217|TWO_SIDED|95.0|0.89|1.37|||ANOVA|Placebo-corrected (MK-8655 / placebo)||||1.37|0.89|0.217
71047576|NCT02192164|141604177|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.757334|STANDARD_ERROR_OF_MEAN|1.594019|||TWO_SIDED|95.0|-5.916307|0.401638||||||||0.401638|-5.916307|
71012741|NCT01590810|141532758|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.77|STANDARD_ERROR_OF_MEAN|1.5|<|0.0001|TWO_SIDED|95.0|-12.9|-6.65|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.65|-12.90|<0.0001
71012742|NCT01590810|141532758|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.19|STANDARD_ERROR_OF_MEAN|2.1||0.003|TWO_SIDED|95.0|-11.57|-2.81|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.81|-11.57|0.003
71012743|NCT01590810|141532758|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.19|STANDARD_ERROR_OF_MEAN|2.02||0.001|TWO_SIDED|95.0|-12.4|-3.98|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.98|-12.40|0.001
71012744|NCT01590810|141532758|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.47|STANDARD_ERROR_OF_MEAN|2.02||0.001|TWO_SIDED|95.0|-11.69|-3.25|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.25|-11.69|0.001
71012745|NCT01590810|141532759|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|1.04||0.765|TWO_SIDED|95.0|-1.82|2.45|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.45|-1.82|0.765
71012746|NCT01590810|141532759|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.56||0.023|TWO_SIDED|95.0|-2.49|-0.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.20|-2.49|0.023
71012747|NCT01590810|141532759|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.77|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-9.18|-4.36|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-4.36|-9.18|<0.0001
71012748|NCT01590810|141532759|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.45|STANDARD_ERROR_OF_MEAN|1.95||0.01|TWO_SIDED|95.0|-9.46|-1.44|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-1.44|-9.46|0.010
71103970|NCT03863574|141715277|OTHER|Proof-of-concept||||||0.7435|||||||t-test, 2 sided|||Outcome Variable: Very low-density lipoprotein||||0.7435
71103971|NCT03863574|141715277|OTHER|Proof-of-concept||||||0.5702|||||||t-test, 2 sided|||Outcome Variable: non-HDL Cholesterol||||0.5702
70941415|NCT02567227|141383499|SUPERIORITY||Mean Difference (Net)|0.39|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-1.38|2.16|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in reported fear of falling measured on the Falls Efficacy Scale pre and post intervention.||2.16|-1.38|
71047577|NCT02192164|141604178|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.911449|STANDARD_ERROR_OF_MEAN|1.426517|||TWO_SIDED|95.0|-3.73847|1.915572||||||||1.915572|-3.73847|
71047578|NCT00359788|141604188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|||<|0.0001|TWO_SIDED|95.0|0.055|0.157|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.157|0.055|<0.0001
71103972|NCT03863574|141715277|OTHER|Proof-of-concept||||||0.6441|||||||t-test, 2 sided|||Outcome Variable: non-HDL Cholesterol||||0.6441
71103973|NCT03863574|141715277|OTHER|Proof-of-concept||||||0.8415|||||||t-test, 2 sided|||Outcome Variable: Apo lipoprotein A1||||0.8415
71012749|NCT01590810|141532759|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.61|STANDARD_ERROR_OF_MEAN|1.3|<|0.0001|TWO_SIDED|95.0|-11.28|-5.94|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.94|-11.28|<0.0001
71012750|NCT01590810|141532760|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.02|STANDARD_ERROR_OF_MEAN|1.39||0.16|TWO_SIDED|95.0|-4.89|0.86|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||0.86|-4.89|0.160
71047579|NCT00359788|141604189|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.05 liters|Mean Difference (Final Values)|0.02||||0.0042||95.0|-0.032|0.072|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.072|-0.032|0.0042
71103974|NCT03863574|141715277|OTHER|Proof-of-concept||||||0.0786|||||||t-test, 2 sided|||Outcome Variable: Apo lipoprotein A1||||0.0786
71012751|NCT01590810|141532760|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.32|STANDARD_ERROR_OF_MEAN|1.97||0.039|TWO_SIDED|95.0|-8.4|-0.24|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.24|-8.40|0.039
71012752|NCT01590810|141532760|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.75|STANDARD_ERROR_OF_MEAN|2.34||0.003|TWO_SIDED|95.0|-12.58|-2.92|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.92|-12.58|0.003
71012753|NCT01590810|141532760|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.79|STANDARD_ERROR_OF_MEAN|2.27|<|0.001|TWO_SIDED|95.0|-14.49|-5.09|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.09|-14.49|<0.001
71012754|NCT01590810|141532760|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.31|STANDARD_ERROR_OF_MEAN|1.45|<|0.0001|TWO_SIDED|95.0|-11.3|-5.31|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.31|-11.30|<0.0001
71012755|NCT01590810|141532761|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|4.0||0.675|TWO_SIDED|95.0|-10.54|7.09|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.09|-10.54|0.675
71012756|NCT01590810|141532761|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.76|STANDARD_ERROR_OF_MEAN|4.64||0.174|TWO_SIDED|95.0|-16.98|3.46|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.46|-16.98|0.174
71012757|NCT01590810|141532761|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.68|STANDARD_ERROR_OF_MEAN|4.03||0.006|TWO_SIDED|95.0|-22.55|-4.81|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-4.81|-22.55|0.006
71012758|NCT01590810|141532762|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.12|STANDARD_ERROR_OF_MEAN|1.49|<|0.0001|TWO_SIDED|95.0|-12.22|-6.03|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.03|-12.22|<0.0001
71047580|NCT00359788|141604190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|||<|0.0001||95.0|0.098|0.193|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.193|0.098|<0.0001
71047581|NCT00359788|141604191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|||<|0.0001||95.0|-0.114|-0.046|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.046|-0.114|<0.0001
71103975|NCT03863574|141715277|OTHER|Proof-of-concept||||||0.8878|||||||t-test, 2 sided|||Outcome Variable: Apo lipoprotein B||||0.8878
71103976|NCT03863574|141715277|OTHER|Proof-of-concept||||||0.3219|||||||t-test, 2 sided|||Outcome variable: Apo lipoprotein B||||0.3219
71103977|NCT03863574|141715277|OTHER|Proof-of-concept||||||0.6557|||||||t-test, 2 sided|||Outcome Variable: Small dense LDL||||0.6557
71103978|NCT03863574|141715277|OTHER|Proof-of-concept||||||0.0763|||||||t-test, 2 sided|||Outcome Variable: Small dense LDL||||0.0763
71103979|NCT03863574|141715279|OTHER|Proof-of-concept||||||0.6988|||||||t-test, 2 sided|||||||0.6988
71047582|NCT00359788|141604192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054||||0.0447||95.0|0.001|0.106|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.106|0.001|0.0447
71047583|NCT00359788|141604193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.131|||<|0.0001||95.0|-0.171|-0.092|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.092|-0.171|<0.0001
71047584|NCT00359788|141604194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.152|||<|0.0001||95.0|-0.19|-0.113|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.113|-0.19|<0.0001
71047585|NCT00359788|141604195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.133|||<|0.0001||95.0|-0.175|-0.091|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.091|-0.175|<0.0001
71103980|NCT03863574|141715279|OTHER|Proof-of-concept||||||0.7413|||||||t-test, 2 sided|||||||0.7413
71103981|NCT03863574|141715280|OTHER|Proof-of-concept||||||0.22|||||||t-test, 2 sided|||||||0.2200
71103982|NCT03863574|141715280|OTHER|Proof-of-concept||||||0.5798|||||||t-test, 2 sided|||||||0.5798
71103983|NCT03863574|141715281|OTHER|Proof-of-concept||||||0.4981|||||||t-test, 2 sided|||||||0.4981
71103984|NCT03863574|141715281|OTHER|Proof-of-concept||||||0.8939|||||||t-test, 2 sided|||||||0.8939
71103985|NCT03863574|141715282|OTHER|Proof-of-concept||||||0.3605|||||||t-test, 2 sided|||||||0.3605
71012759|NCT01590810|141532762|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.86|STANDARD_ERROR_OF_MEAN|1.38|<|0.0001|TWO_SIDED|95.0|-9.73|-3.99|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.99|-9.73|<0.0001
71012760|NCT01590810|141532762|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.57|STANDARD_ERROR_OF_MEAN|1.41|<|0.0001|TWO_SIDED|95.0|-11.51|-5.64|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.64|-11.51|<0.0001
71012761|NCT01590810|141532762|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.52|STANDARD_ERROR_OF_MEAN|1.45|<|0.0001|TWO_SIDED|95.0|-12.55|-6.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.50|-12.55|<0.0001
71012762|NCT04604015|141532763|OTHER||absolute difference|41.0|||<|0.001|TWO_SIDED|95.0|32.9|50.2|||McNemar|||The study was powered based on the results of a meta-analysis reporting the pooled NeuralBot (TCD) sensitivity for Right to Left Shunt detection, and the pooled TTE sensitivity for Right to Left Shunt detection.||50.2|32.9|<0.001
71012763|NCT03655951|141532768|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.2|||||||Regression, Linear|||||||.20
71012764|NCT03655951|141532769|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.69|||||||Regression, Linear|||||||.69
71012765|NCT03655951|141532770|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.48|||||||Regression, Linear|||||||.48
71012766|NCT03655951|141532771|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.36|||||||Regression, Linear|||||||.36
71012767|NCT03655951|141532772|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.48|||||||Regression, Linear|||||||.48
71012768|NCT03655951|141532773|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.41|||||||Regression, Linear|||||||.41
71012769|NCT03655951|141532774|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.87|||||||Regression, Linear|||||||.87
71012770|NCT03655951|141532775|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.8|||||||Regression, Linear|||||||.8
71012771|NCT03655951|141532776|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.32|||||||Regression, Linear|||||||.32
71012772|NCT03655951|141532777|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.03|||||||Regression, Linear|||||||.03
71012773|NCT03655951|141532778|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.05|||||||Regression, Linear|||||||.05
71012774|NCT03655951|141532779|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.04|||||||Regression, Linear|||||||.04
71012775|NCT03655951|141532780|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.42|||||||Regression, Linear|||||||.42
71012776|NCT03655951|141532781|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.11|||||||Regression, Linear|||||||.11
71012777|NCT03655951|141532782|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.0003|||||||Regression, Linear|||||||.0003
71012778|NCT03655951|141532783|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.97|||||||Regression, Linear|||||||.97
71012779|NCT03655951|141532784|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.08|||||||Regression, Linear|||||||.08
71012780|NCT03655951|141532785|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.7|||||||Regression, Linear|||||||.70
71012781|NCT03655951|141532786|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.03|||||||Regression, Linear|||||||.03
71012782|NCT03655951|141532787|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.29|||||||Regression, Linear|||||||.29
71012783|NCT03655951|141532788|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.36|||||||Regression, Linear|||||||.36
71012784|NCT03655951|141532789|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.61|||||||Regression, Linear|||||||.61
71012785|NCT03655951|141532790|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.72|||||||Regression, Linear|||||||.72
71012786|NCT03655951|141532791|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.05|||||||Regression, Linear|||||||.05
71012787|NCT03655951|141532792|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.09|||||||Regression, Linear|||||||.09
71012788|NCT03655951|141532793|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.69|||||||Regression, Linear|||||||.69
71047586|NCT00359788|141604196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175||||0.0015||95.0|0.067|0.283|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.283|0.067|0.0015
71047587|NCT00359788|141604197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011||||0.835||95.0|-0.092|0.114|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.114|-0.092|0.835
71047588|NCT00359788|141604198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|||<|0.0001||95.0|0.178|0.379|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.379|0.178|<0.0001
71047589|NCT00359788|141604199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.157|||<|0.0001||95.0|-0.236|-0.078|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.078|-0.236|<0.0001
71047590|NCT00359788|141604200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039||||0.4386||95.0|-0.059|0.137|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.137|-0.059|0.4386
71047591|NCT00359788|141604201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.282||||0.0001||95.0|-0.374|-0.191|||ANCOVA|||||-0.191|-0.374|0.0001
71047592|NCT00359788|141604202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.361|||<|0.0001||95.0|-0.449|-0.274|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.274|-0.449|<0.0001
71047593|NCT00359788|141604203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.286|||<|0.0001||95.0|-0.375|-0.196|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.196|-0.375|<0.0001
71047594|NCT00359788|141604204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.175|||<|0.0001||95.0|-0.207|-0.142|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.142|-0.207|<0.0001
71047595|NCT00359788|141604205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.168|||<|0.0001||95.0|-0.205|-0.131|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.131|-0.205|<0.0001
71047596|NCT00359788|141604206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.182|||<|0.0001||95.0|-0.221|-0.143|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.143|-0.221|<0.0001
71047597|NCT00359788|141604207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.136|||<|0.0001||95.0|-0.175|-0.097|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.097|-0.175|<0.0001
71047598|NCT00359788|141604208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.084|||<|0.0001||95.0|-0.125|-0.044|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.044|-0.125|<0.0001
71047599|NCT00359788|141604209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.035||||0.0997||95.0|-0.076|0.007|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.007|-0.076|0.0997
71047600|NCT00359788|141604210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037||||0.101||95.0|-0.007|0.08|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.08|-0.007|0.101
71047601|NCT00359788|141604211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|||<|0.0001||95.0|0.098|0.193|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.193|0.098|<0.0001
71103986|NCT03863574|141715282|OTHER|Proof-of-concept||||||0.8394|||||||t-test, 2 sided|||||||0.8394
71103987|NCT03863574|141715283|OTHER|Proof-of-concept||||||0.2665|||||||t-test, 2 sided|||||||0.2665
70941416|NCT02567227|141383500|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.64|||TWO_SIDED|95.0|-1.46|1.04|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the physical health score of the SF-12 pre and post intervention.||1.04|-1.46|
71012789|NCT03655951|141532794|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.11|||||||Regression, Linear|||||||.11
71012790|NCT03655951|141532795|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.27|||||||Regression, Linear|||||||.27
71012791|NCT03655951|141532796|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.83|||||||Regression, Linear|||||||.83
71012792|NCT03655951|141532797|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.0001|||||||Regression, Linear|||||||.0001
71012793|NCT03655951|141532798|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.2|||||||Regression, Linear|||||||.20
71012794|NCT03655951|141532799|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.09|||||||Regression, Linear|||||||.09
71012795|NCT03655951|141532800|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.62|||||||Regression, Linear|||||||.62
71012796|NCT03655951|141532801|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.29|||||||Regression, Linear|||||||.29
71012797|NCT03655951|141532802|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.14|||||||Regression, Linear|||||||.14
71012798|NCT03655951|141532803|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.008|||||||Regression, Linear|||||||.008
71047602|NCT00359788|141604212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.055||||0.0411||95.0|-0.108|-0.002|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.002|-0.108|0.0411
71047603|NCT00359788|141604213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.0354||95.0|-0.116|-0.004|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.004|-0.116|0.0354
71012799|NCT03655951|141532804|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.02|||||||Regression, Linear|||||||.02
71047604|NCT00359788|141604214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.062||||0.041||95.0|-0.121|-0.003|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.003|-0.121|0.041
71047605|NCT00359788|141604215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.018||||0.5387||95.0|-0.076|0.04|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.04|-0.076|0.5387
71047606|NCT00359788|141604216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061||||0.0372||95.0|0.004|0.118|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.118|0.004|0.0372
71012800|NCT03655951|141532805|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.03|||||||Regression, Linear|||||||.03
71012801|NCT03655951|141532806|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.69|||||||Regression, Linear|||||||.69
71012802|NCT03655951|141532807|EQUIVALENCE|Binary outcomes were assessed with logistic regression.||||||0.4|||||||Regression, Logistic|||||||.4
71012803|NCT03655951|141532808|EQUIVALENCE|Binary outcomes were assessed with logistic regression.||||||0.02|||||||Regression, Logistic|||||||.02
71012804|NCT03655951|141532809|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.27|||||||Regression, Linear|||||||.27
71012805|NCT03655951|141532810|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.31|||||||Regression, Linear|||||||.31
71047607|NCT00359788|141604217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|||<|0.0001||95.0|0.066|0.177|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.177|0.066|<0.0001
71047608|NCT00359788|141604218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|||<|0.0001||95.0|0.108|0.216|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.216|0.108|<0.0001
71103988|NCT03863574|141715283|OTHER|Proof-of-concept||||||0.9133|||||||t-test, 2 sided|||||||0.9133
71103989|NCT03863574|141715284|OTHER|Proof-of-concept||||||0.7267|||||||t-test, 2 sided|||||||0.7267
71012806|NCT03655951|141532811|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.11|||||||Regression, Linear|||||||.11
71012807|NCT03655951|141532812|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.89|||||||Regression, Linear|||||||.89
71012808|NCT03655951|141532813|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.41|||||||Regression, Linear|||||||.41
71047609|NCT00359788|141604219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|||<|0.0001||95.0|0.055|0.157|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.157|0.055|<0.0001
71047610|NCT00359788|141604220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.083||||0.0023||95.0|-0.136|-0.03|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.03|-0.136|0.0023
71047611|NCT00359788|141604221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.087||||0.0019||95.0|-0.142|-0.033|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.033|-0.142|0.0019
71047612|NCT00359788|141604222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.083||||0.0044||95.0|-0.139|-0.026|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.026|-0.139|0.0044
71047613|NCT00359788|141604223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.046||||0.1182||95.0|-0.103|0.012|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.012|-0.103|0.1182
71047614|NCT00359788|141604224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.4814||95.0|-0.037|0.078||ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|ANCOVA|||||0.078|-0.037|0.4814
71047615|NCT00359788|141604225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.074||||0.008||95.0|0.019|0.129|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.129|0.019|0.008
71047616|NCT00359788|141604226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|||<|0.0001||95.0|0.082|0.19|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.19|0.082|<0.0001
71047617|NCT00359788|141604227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|||<|0.0001||95.0|-0.449|-0.29|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.29|-0.449|<0.0001
71047618|NCT00359788|141604228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.356|||<|0.0001||95.0|-0.44|-0.272|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.272|-0.44|<0.0001
71047619|NCT00359788|141604229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.357|||<|0.0001||95.0|-0.451|-0.264|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.264|-0.451|<0.0001
71047620|NCT00359788|141604230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.285|||<|0.0001||95.0|-0.376|-0.194|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.194|-0.376|<0.0001
71012809|NCT03655951|141532814|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.93|||||||Regression, Linear|||||||.93
71047621|NCT00359788|141604231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.0003||95.0|-0.261|-0.079|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.079|-0.261|0.0003
71047622|NCT00359788|141604232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.2992||95.0|-0.143|0.044|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.044|-0.143|0.2992
71012810|NCT03655951|141532815|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.83|||||||Regression, Linear|||||||.83
71012811|NCT03655951|141532816|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.04|||||||Regression, Linear|||||||.04
71012812|NCT03655951|141532817|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.13|||||||Regression, Linear|||||||.13
71047623|NCT00359788|141604233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081||||0.0984||95.0|-0.015|0.177|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.177|-0.015|0.0984
71047624|NCT00359788|141604234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|||<|0.0001||95.0|0.178|0.379|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.379|0.178|<0.0001
71047625|NCT00359788|141604235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.189||||0.0004||95.0|-0.293|-0.086|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.086|-0.293|0.0004
71047626|NCT00359788|141604236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.204||||0.0003||95.0|-0.314|-0.095|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.095|-0.314|0.0003
71047627|NCT00359788|141604237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1832||||0.012||95.0|-0.293|-0.072|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.072|-0.293|0.012
71047628|NCT00359788|141604238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.097||||0.044||95.0|-0.219|0.003|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.003|-0.219|0.044
71103990|NCT03863574|141715284|OTHER|Proof-of-concept||||||0.9211|||||||t-test, 2 sided|||||||0.9211
71103991|NCT03863574|141715285|OTHER|Proof-of-concept||||||0.8683|||||||t-test, 2 sided|||||||0.8683
71103992|NCT03863574|141715285|OTHER|Proof-of-concept||||||0.7436|||||||t-test, 2 sided|||||||0.7436
71012813|NCT03655951|141532818|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.56|||||||Regression, Linear|||||||.56
71012814|NCT03655951|141532819|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.96|||||||Regression, Linear|||||||.96
71012815|NCT03655951|141532820|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.35|||||||Regression, Linear|||||||.35
71012816|NCT03655951|141532821|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.24|||||||Regression, Linear|||||||.24
71012817|NCT03655951|141532822|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.2|||||||Regression, Linear|||||||.2
71012818|NCT03655951|141532823|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.18|||||||Regression, Linear|||||||.18
71012819|NCT03655951|141532824|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.67|||||||Regression, Linear|||To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||.67
71012820|NCT03655951|141532825|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.57|||||||Regression, Linear|||||||.57
71012821|NCT03655951|141532826|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.65|||||||Regression, Linear|||||||.65
71012822|NCT03655951|141532827|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.84|||||||Regression, Linear|||||||.84
71012823|NCT03655951|141532828|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.02|||||||Regression, Linear|||||||.02
71012824|NCT03655951|141532829|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.65|||||||Regression, Linear|||||||.65
71047629|NCT00359788|141604239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.3634||95.0|-0.058|0.158|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.158|-0.058|0.3634
71047630|NCT00359788|141604240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.163||||0.0032||95.0|0.055|0.27|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.27|0.055|0.0032
71047631|NCT00359788|141604241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.275|||<|0.0001||95.0|0.173|0.378|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.378|0.173|<0.0001
71047632|NCT00359788|141604242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175||||0.0015||95.0|0.067|0.283|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.283|0.067|0.0015
71047633|NCT00359788|141604243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.193||||0.0002||95.0|-0.296|-0.091|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.091|-0.296|0.0002
71047634|NCT00359788|141604244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.215|||<|0.0001||95.0|-0.323|-0.108|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.108|-0.323|<0.0001
71047635|NCT00359788|141604245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.198||||0.0006||95.0|-0.309|-0.086|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.086|-0.309|0.0006
71047636|NCT00359788|141604246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.097||||0.0896||95.0|-0.21|0.015|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.015|-0.21|0.0896
71047637|NCT00359788|141604247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008||||0.8937||95.0|-0.103|0.118|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.118|-0.103|0.8937
71047638|NCT00359788|141604248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125||||0.0269||95.0|0.014|0.236|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.236|0.014|0.0269
71047639|NCT00359788|141604249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.223||||0.0001||95.0|0.111|0.335|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.335|0.111|0.0001
71047640|NCT00359788|141604250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042||||0.7196||95.0|-0.275|0.19|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.19|-0.275|0.7196
71047641|NCT00359788|141604251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.069||||0.6189||95.0|-0.343|0.205|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.205|-0.343|0.6189
71047642|NCT00359788|141604252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.073||||0.6197||95.0|-0.36|0.215|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.215|-0.36|0.6197
71103993|NCT05081843|141715294|SUPERIORITY||Mean Difference (Final Values)|0.233||||0.05|TWO_SIDED|95.0|-0.056|0.522|||t-test, 2 sided|||||0.522|-0.056|0.05
71012825|NCT03655951|141532830|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.09|||||||Regression, Linear|||||||.09
71103994|NCT05081843|141715295|SUPERIORITY||Median Difference (Final Values)|0.534||||0.05|TWO_SIDED|95.0|0.078|0.99|||t-test, 2 sided|||||0.990|0.078|0.05
71012826|NCT03655951|141532831|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.95|||||||Regression, Linear|||||||.95
71012827|NCT03655951|141532832|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.47|||||||Regression, Linear|||||||.47
71103995|NCT05081843|141715296|SUPERIORITY||Mean Difference (Final Values)|0.326||||0.05|TWO_SIDED|95.0|-0.177|0.829|||t-test, 2 sided|||||0.829|-0.177|0.05
71103996|NCT05081843|141715297|SUPERIORITY||Mean Difference (Final Values)|0.756||||0.05|TWO_SIDED|95.0|0.208|1.31|||t-test, 2 sided|||||1.31|0.208|0.05
71103997|NCT02303821|141715304|OTHER||||||||||||||||||The objective of this endpoint was to compare the rate of CRi or better status against an external control arm selected from an observational study (Amgen 20180065). The rate of CRi or better status in the external control arm was 26.3% (95% CI: 15.1, 37.5) for B-Cell participants with treatment difference odds ratio of 2.082 (95% CI: 0.968, 4.477). For T-Cell participants the rate of CRi or better status was 18.6% (95% CI: 7.1, 30.0) with treatment difference odds ratio of 1.646 (95% CI: 0.639. 4.245).|||
71103998|NCT02303821|141715305|OTHER||||||||||||||||||The objective of this endpoint was to compare EFS in study 20140106 with EFS in an external control arm selected from an observational study (Amgen 20180065). The median duration in months in the external control arm was 3.62 (95% CI: 1.55, 5.36) for B-cell participants, with a treatment difference hazard ration of 1.435 (95% CI: 0.976, 2.111). For T-Cell participants the median in months was 2.93 (95% CI: 0.95, 5.10) with a treatment difference hazard ratio of 1.404 (95% CI: 0.869, 2.270).|||
71103999|NCT02303821|141715306|OTHER||||||||||||||||||The objective of this endpoint was to compare the OS in study 20140106 with OS in an external control arm selected from an observational study (Amgen 20180065). The median OS in months for the B-Cell participants in the external control arm was 8.59 (95% CI: 5.26, 10.59) with a treatment difference hazard ratio of 1.245 (95% CI: 0.805, 1.927). For the T-Cell participants the median OS in months was 7.04 (95% CI: 7.04, NE) with a treatment difference hazard ratio of 1.040 (95% CI: 0.641, 1.688).|||
71012828|NCT03655951|141532833|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.003|||||||Regression, Linear|||||||.003
71012829|NCT03655951|141532834|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.77|||||||Regression, Linear|||||||.77
71012830|NCT03655951|141532835|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.|||||<|0.001|||||||Regression, Linear|||||||<.001
71012831|NCT03655951|141532836|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.06|||||||Regression, Linear|||||||.06
71012832|NCT03655951|141532837|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.91|||||||Regression, Linear|||||||.91
71104000|NCT02303821|141715307|OTHER||||||||||||||||||The DOR in study 20140106 was estimated relative to the DOR in an external control arm selected from an observational study (Amgen 20180065). The median DOR in months in the external control arm was 8.72 (95% CI: 5.07, 32.24) in B-Cell participants. For T-Cell participants the median DOR in months was 5.82 (95% CI: 1.22, 19.80).|||
71104001|NCT02303821|141715319|OTHER||||||||||||||||||The primary objective of this endpoint was to compare the percentage of participants achieving CR after the end of induction therapy in study 20140106 with the percentage of participants achieving CR in an external control arm selected from an observational study (Amgen 20180065). In the external control arm, 7.8% of B-Cell participants (95% confidence interval \[CI\]: 1.0%, 14.7%) achieved CR, with a treatment difference odds ratio of 2.04 (95% CI: 0.54, 7.66). For T-Cell participants, 9.1% (95% CI: 0.7%, 17.5%) achieved CR, with an odds ratio of 1.58 (95% CI: 0.47, 5.31).|||
71104002|NCT04116489|141715326|SUPERIORITY|||||||0.5272|||||||Regression, Linear|||||||.5272
71104003|NCT04116489|141715327|SUPERIORITY|||||||0.1657|||||||Regression, Linear|||||||.1657
71104004|NCT04116489|141715328|SUPERIORITY|||||||0.2437|||||||Regression, Linear|||||||.2437
71104005|NCT04116489|141715329|OTHER|||||||0.0373|||||||Regression, Linear|||||||.0373
71104006|NCT01346592|141715376|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \>0.667|GMT ratio (H1N1 strain)|2.44|||||TWO_SIDED|97.6|2.06|2.9||||||||2.9|2.06|
71104007|NCT01346592|141715376|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \>0.667|GMT ratio (H3N2 strain)|1.89|||||TWO_SIDED|97.6|1.69|2.1||||||||2.1|1.69|
71104008|NCT01346592|141715376|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \>0.667|GMT ratio (B strain)|3.07|||||TWO_SIDED|97.6|2.66|3.54||||||||3.54|2.66|
71104009|NCT01346592|141715376|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \>0.667|GMT ratio (H1N1 strain)|3.2|||||TWO_SIDED|97.6|2.7|3.8||||||||3.8|2.7|
71104010|NCT01346592|141715376|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \>0.667|GMT ratio (H3N2 strain)|2.38|||||TWO_SIDED|97.6|2.14|2.65||||||||2.65|2.14|
71104011|NCT01346592|141715376|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \>0.667|GMT ratio (B strain)|3.14|||||TWO_SIDED|97.6|2.72|3.62||||||||3.62|2.72|
71104012|NCT01346592|141715377|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \>-10%.|Group difference (H1N1 strain)|9.09|||||TWO_SIDED|97.6|5.48|12.69||||||||12.69|5.48|
71104013|NCT01346592|141715377|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \>-10%|Group difference (H3N2 strain)|4.07|||||TWO_SIDED|97.6|1.58|6.55||||||||6.55|1.58|
71104014|NCT01346592|141715377|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \> -10%|Group difference (B strain)|11.82|||||TWO_SIDED|97.6|8.72|14.92||||||||14.92|8.72|
71104015|NCT01346592|141715377|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \> -10%|Group difference (H1N1 strain)|14.21|||||TWO_SIDED|97.6|10.3|18.13||||||||18.13|10.3|
71104016|NCT01346592|141715377|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \> -10%|Group difference (H3N2 strain)|7.31|||||TWO_SIDED|97.6|4.47|10.14||||||||10.14|4.47|
71012833|NCT03655951|141532838|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.95|||||||Regression, Linear|||||||.95
71012834|NCT03655951|141532839|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.12|||||||Regression, Linear|||||||.12
71012835|NCT03655951|141532840|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.98|||||||Regression, Linear|||||||.98
71012836|NCT03655951|141532841|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.57|||||||Regression, Linear|||||||.57
71012837|NCT03655951|141532842|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.98|||||||Regression, Linear|||||||.98
71012838|NCT03655951|141532843|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.07|||||||Regression, Linear|||||||.07
71012839|NCT03655951|141532844|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.02|||||||Regression, Linear|||||||.02
71012840|NCT03655951|141532845|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.15|||||||Regression, Linear|||||||.15
71012841|NCT00129220|141532851|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.62|||<|0.001|TWO_SIDED|95.0|-8.87|-2.37|||ANCOVA||Least Squares Mean Difference = Olanzapine minus Placebo.|||-2.37|-8.87|<0.001
71012842|NCT00129220|141532852|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.78||||0.774|TWO_SIDED|95.0|-6.15|4.59|||ANCOVA||Least Squares Mean Difference = Olazapine minus Haloperidol.|||4.59|-6.15|0.774
71012843|NCT00129220|141532853|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|21.0||||0.064|TWO_SIDED|95.0|1.6|40.4|||Cochran-Mantel-Haenszel||Least Squares Mean Difference = Olanzapine minus Haloperidol.|||40.4|1.6|0.064
71012844|NCT00129220|141532854|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47||||0.171|TWO_SIDED|95.0|-1.15|0.21|||ANCOVA||Least Squares Mean Difference = Olanzapine minus Haloperidol.|||0.21|-1.15|0.171
71012845|NCT00129220|141532855|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.51||||0.006|TWO_SIDED|95.0|-0.87|-0.15||P-value for 3-Week Change.|ANCOVA||Least Squares Mean Difference = Olanzapine minus Placebo.|||-0.15|-0.87|0.006
71012846|NCT00129220|141532855|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.13||||0.722|TWO_SIDED|95.0|-0.82|0.57||P-value for 6-Week Change.|ANCOVA||Least Squares Mean Difference = Olanzapine minus Haloperidol.|||0.57|-0.82|0.722
71012847|NCT00129220|141532856|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.7||||0.333|TWO_SIDED|95.0|-6.7|20.1||P-value for 3-Week Response Rate.|Cochran-Mantel-Haenszel|||||20.1|-6.7|0.333
71104017|NCT01346592|141715377|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \> -10%|Group difference (B strain)|11.1|||||TWO_SIDED|97.6|8.11|14.1||||||||14.1|8.11|
71104018|NCT01346592|141715378|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 GMT group ratios was \>0.667|Group ratio (H1N1 strain)|0.76|||||TWO_SIDED|97.4|0.62|0.93||||||||0.93|0.62|
71104019|NCT01346592|141715378|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 GMT group ratios was \>0.667|GMT ratio (H3N2 strain)|0.77|||||TWO_SIDED|97.4|0.68|0.86||||||||0.86|0.68|
71104020|NCT01346592|141715378|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 GMT group ratios was \>0.667|GMT ratio (B strain)|0.94|||||TWO_SIDED|97.4|0.8|1.11||||||||1.11|0.8|
71104021|NCT01346592|141715379|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group differences was \> -10%|Group difference (H1N1 strain)|-5.3|||||TWO_SIDED|97.4|-10.13|-0.47||||||||-0.47|-10.13|
71012848|NCT00129220|141532856|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.908|TWO_SIDED|95.0|-21.0|18.4||P-value for 6-Week Response Rate.|Cochran-Mantel-Haenszel|||||18.4|-21.0|0.908
71012849|NCT00129220|141532857|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.9||||0.384|TWO_SIDED|95.0|-7.3|19.2||P-value for 3-Week Remission Rate.|Cochran-Mantel-Haenszel||Least Squares Mean Difference = Olanzapine minus Placebo.|||19.2|-7.3|0.384
71012850|NCT00129220|141532857|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.3||||0.982|TWO_SIDED|95.0|-21.3|21.8||P-value is for 6-Week Remission Rate|Cochran-Mantel-Haenszel||Least Squares Mean Difference = Olanzapine minus Haloperidol.|||21.8|-21.3|0.982
71012851|NCT00129220|141532858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8||||0.698|TWO_SIDED|95.0|-3.2|4.9||P-value for 3-Week Symptomatic Depression Rate.|Cochran-Mantel-Haenszel|||||4.9|-3.2|0.698
71012852|NCT00129220|141532858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.1||||0.014|TWO_SIDED|95.0|-31.7|3.4||P-value for 6-Week Symptomatic Depression Rate.|Cochran-Mantel-Haenszel|||||3.4|-31.7|0.014
71012853|NCT00129220|141532859|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.48||||0.019|TWO_SIDED|95.0|-2.71|-0.25||P-value for 3-Week Change.|ANCOVA||Least Squares Mean Difference = Olanzapine minus Placebo.|||-0.25|-2.71|0.019
71012854|NCT00129220|141532859|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.16||||0.855|TWO_SIDED|95.0|-1.95|1.62||P-value for 6-Week Change.|ANCOVA||Least Squares Mean Difference = Olanzapine minus Haloperidol.|||1.62|-1.95|0.855
71012855|NCT00129220|141532860|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.6||||0.136|TWO_SIDED|95.0|-14.9|5.7||P-value for 6-Week Syndromic Depression Rate.|Cochran-Mantel-Haenszel|||||5.7|-14.9|0.136
71012856|NCT00129220|141532861|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Maximum Change from Baseline.|Wilcoxon Rank Sum|||||||0.003
71012857|NCT01883362|141532862|SUPERIORITY||Hazard Ratio (HR)|0.46||||0.2655|TWO_SIDED|95.0|0.12|1.86|||Log Rank|||||1.86|0.12|0.2655
71012858|NCT01883362|141532863|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.4297|TWO_SIDED|95.0|0.17|2.14|||Log Rank|||||2.14|0.17|0.4297
71012859|NCT01883362|141532864|SUPERIORITY||Hazard Ratio (HR)|0.55||||0.2424|TWO_SIDED|95.0|0.2|1.52|||Log Rank|||||1.52|0.20|0.2424
71012860|NCT01883362|141532865|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.4297|TWO_SIDED|95.0|0.17|2.14|||Log Rank|||||2.14|0.17|0.4297
71012861|NCT01883362|141532866|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.3418|TWO_SIDED|95.0|0.19|1.79|||Log Rank|||||1.79|0.19|0.3418
71012862|NCT01883362|141532867|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.4169|TWO_SIDED|95.0|0.09|2.74|||Log Rank|||||2.74|0.09|0.4169
71012863|NCT01790633|141532941|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value adjustments for multiple comparisons were not necessary. Significance was determined using P \< 0.05|Chi-squared|||We approached our analysis as a pilot study with the aim of addressing feasibility. 70% of patients seen at the MDM clinic obtain a test result with standard serology. Assuming a 20% increase in infection awareness and type 1 error of 0.05, and power of at least 0.9, a minimum of 82 participants per group would be needed.||||<0.001
71012864|NCT01790633|141532942|SUPERIORITY_OR_OTHER|||||||0.7||||||P-value adjustments for multiple comparisons were not necessary. Significance was determined using P \< 0.05|Chi-squared|||||||0.7
71012865|NCT02883400|141532983|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0001
71012866|NCT00333437|141532984|SUPERIORITY_OR_OTHER||Change from Baseline|0.1786|STANDARD_DEVIATION|0.1613||0.026|TWO_SIDED|95.0|0.0294|0.3277||Not adjusted|t-test, 2 sided|||H(0): post-pre FVC (liters) = 0||0.3277|0.0294|0.026
71012867|NCT00333437|141532985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|8.1035||0.3652|TWO_SIDED|95.0|-10.49|4.4945||significant p\<0.05|t-test, 2 sided|||H(0): Post-pre neutrophil count = 0||4.4945|-10.49|0.3652
71012868|NCT00333437|141532985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.286|STANDARD_DEVIATION|16.358||0.3485|TWO_SIDED|95.0|-21.41|8.8426||significant p\<0.05|t-test, 2 sided|||H(0): post-pre eosinophil count = 0||8.8426|-21.41|0.3485
71012869|NCT00333437|141532987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|264.26|STANDARD_DEVIATION|194.66||0.0115|TWO_SIDED|95.0|84.256|444.32||Significant p\<0.05|t-test, 2 sided|Not adjusted||H(0): post-pre walk distance = 0||444.32|84.256|0.0115
71012870|NCT00333437|141532988|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8643|STANDARD_DEVIATION|1.5013||0.0167|TWO_SIDED|95.0|0.4758|3.2527||significant p\<0.05|t-test, 2 sided|||H(0): Post-pre DLCO = 0||3.2527|0.4758|0.0167
71012871|NCT03022526|141532993|SUPERIORITY|||||||0.7463|||||||t-test, 2 sided|||||||0.7463
71012872|NCT03022526|141532994|SUPERIORITY|||||||0.5764|||||||t-test, 2 sided|||||||0.5764
71012873|NCT03022526|141532995|SUPERIORITY|||||||0.7169|||||||t-test, 2 sided|||||||0.7169
71012874|NCT03022526|141532996|SUPERIORITY|||||||0.4226|||||||t-test, 2 sided|||||||0.4226
71012875|NCT03022526|141532997|SUPERIORITY|||||||0.6873|||||||t-test, 2 sided|||||||0.6873
71012876|NCT03022526|141532998|SUPERIORITY|||||||0.0452|||||||Chi-squared|||||||0.0452
71012877|NCT03022526|141532999|SUPERIORITY|||||||0.0899|||||||Chi-squared|||||||0.0899
71012878|NCT03022526|141533000|SUPERIORITY|||||||0.1265|||||||Chi-squared|||||||0.1265
71012879|NCT03022526|141533001|SUPERIORITY|||||||0.0328|||||||t-test, 2 sided|||||||0.0328
71012880|NCT03022526|141533002|SUPERIORITY|||||||0.6824|||||||t-test, 2 sided|||||||0.6824
71012881|NCT03022526|141533003|SUPERIORITY|||||||0.449|||||||t-test, 2 sided|||||||0.449
71012882|NCT03022526|141533004|SUPERIORITY|||||||0.5996|||||||t-test, 2 sided|||||||0.5996
71012883|NCT03022526|141533005|SUPERIORITY|||||||0.8009|||||||t-test, 2 sided|||||||0.8009
71012884|NCT03022526|141533006|SUPERIORITY|||||||0.5422|||||||t-test, 2 sided|||||||0.5422
71012885|NCT03022526|141533007|SUPERIORITY|||||||0.7374|||||||t-test, 2 sided|||||||0.7374
71012886|NCT00451191|141533010|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Simon's optimal two-stage design|||Simon's optimal two-stage design was applied to determine whether there was sufficient activity at either of the two dose levels to warrant further investigation. Each patient was considered either a successful or failed response. The response rate or proportion of patients treated successfully was examined in two stages. At both stages, the two dose levels were compared to pre-determined critical cut-off values. Sample size was based on significance level α=0.05 and power 90%.||||<0.05
71012887|NCT00798161|141533023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.79|-0.36||hierarchical testing, no adjustment of p-values|ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.36|-0.79|<0.0001
71104022|NCT01346592|141715379|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group differences was \> -10%|Group difference (H3N2 strain)|-2.84|||||TWO_SIDED|97.4|-6.16|0.5||||||||0.5|-6.16|
71104023|NCT01346592|141715379|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group differences was \> -10%|Group difference (B strain)|-2.49|||||TWO_SIDED|97.4|-7.01|2.0||||||||2|-7.01|
71104024|NCT01346592|141715380|SUPERIORITY_OR_OTHER||GMT ratio (H1N1 strain)|3.63|||||TWO_SIDED|95.0|2.86|4.6||||||Superiority was concluded if the lower limit of the confidence interval for the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||4.6|2.86|
71104025|NCT01346592|141715380|SUPERIORITY_OR_OTHER||GMT ratio (H3N2 strain)|2.25|||||TWO_SIDED|95.0|1.96|2.59||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||2.59|1.96|
71104026|NCT01346592|141715380|SUPERIORITY_OR_OTHER||GMT ratio (B strain)|4.64|||||TWO_SIDED|95.0|3.86|5.59||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||5.59|3.86|
71104027|NCT01346592|141715380|SUPERIORITY_OR_OTHER||GMT ratio (H1N1 strain)|5.28|||||TWO_SIDED|95.0|4.16|6.7||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||6.7|4.16|
71104028|NCT01346592|141715380|SUPERIORITY_OR_OTHER||GMT ratio (H3N2 strain)|3.1|||||TWO_SIDED|95.0|2.69|3.56||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||3.56|2.69|
71104029|NCT01346592|141715380|SUPERIORITY_OR_OTHER||GMT ratio (B strain)|4.64|||||TWO_SIDED|95.0|3.86|5.59||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||5.59|3.86|
71104030|NCT01346592|141715381|SUPERIORITY_OR_OTHER||Group difference (H1N1 strain)|10.4|||||TWO_SIDED|95.0|6.1|14.7||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||14.7|6.1|
70928732|NCT04800211|141353086|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-8.333||||0.8713|TWO_SIDED|95.0|-110.097|93.431|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||93.431|-110.097|0.8713
71012888|NCT00798161|141533023|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.73|-0.3||hierarchical testing, no adjustment of p-values|ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.30|-0.73|<0.0001
71012889|NCT00798161|141533023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.99|-0.55||hierarchical testing, no adjustment of p-values|ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.55|-0.99|<0.0001
71012890|NCT00798161|141533023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-1.36|-0.92||hierarchical testing, no adjustment of p-values|ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.92|-1.36|<0.0001
71012891|NCT00798161|141533024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.56|-0.26|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.26|-0.56|<0.0001
71012892|NCT00798161|141533024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.53|-0.23|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.23|-0.53|<0.0001
71012893|NCT00798161|141533024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.65|-0.35|||ANCOVA|||Linagliptin 5mg vs Linagliptin 2.5mg with metformin 500mg||-0.35|-0.65|<0.0001
71012894|NCT00798161|141533024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.79|-0.48|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.48|-0.79|<0.0001
71012895|NCT00798161|141533025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.72|-0.31|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.31|-0.72|<0.0001
71012896|NCT00798161|141533025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.63|-0.22|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.22|-0.63|<0.0001
71012897|NCT00798161|141533025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.92|-0.51|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.51|-0.92|<0.0001
71012898|NCT00798161|141533025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-1.16|-0.75|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.75|-1.16|<0.0001
71012899|NCT00798161|141533026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.73|-0.29|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.29|-0.73|<0.0001
71104031|NCT01346592|141715381|SUPERIORITY_OR_OTHER||Group difference (H3N2 strain)|2.5|||||TWO_SIDED|95.0|-0.12|5.1||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||5.1|-0.12|
71104032|NCT01346592|141715381|SUPERIORITY_OR_OTHER||Group difference (B strain)|12.8|||||TWO_SIDED|95.0|8.9|16.7||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||16.7|8.9|
70928733|NCT04800211|141353087|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-115.256||||0.0003|TWO_SIDED|95.0|-177.973|-52.539|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-52.539|-177.973|0.0003
70928734|NCT04800211|141353087|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-74.904||||0.0467|TWO_SIDED|95.0|-148.706|-1.102|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-1.102|-148.706|0.0467
70928735|NCT04800211|141353087|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-144.035|||<|0.0001|TWO_SIDED|95.0|-206.668|-81.402|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-81.402|-206.668|<.0001
70928736|NCT04800211|141353087|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-62.755||||0.0807|TWO_SIDED|95.0|-133.221|7.71|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||7.710|-133.221|0.0807
71012900|NCT00798161|141533026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.69|-0.26|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.26|-0.69|<0.0001
71012901|NCT00798161|141533026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.94|-0.49|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.49|-0.94|<0.0001
71012902|NCT00798161|141533026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-1.3|-0.86|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.86|-1.30|<0.0001
71012903|NCT00798161|141533027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.4|STANDARD_ERROR_OF_MEAN|5.0||0.0005||95.0|-27.2|-7.6|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-7.6|-27.2|0.0005
71012904|NCT00798161|141533027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.2|STANDARD_ERROR_OF_MEAN|5.0||0.0006||95.0|-27.1|-7.3|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-7.3|-27.1|0.0006
71012905|NCT00798161|141533027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.6|STANDARD_ERROR_OF_MEAN|5.0|<|0.0001||95.0|-34.4|-14.8|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-14.8|-34.4|<0.0001
71012906|NCT00798161|141533027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.8|STANDARD_ERROR_OF_MEAN|5.0|<|0.0001||95.0|-50.6|-31.0|||ANCOVA|||Linagliptin 5mg vs. linagliptin 2.5mg with metformin 1000mg||-31.0|-50.6|<0.0001
71047643|NCT00359788|141604253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.112||||0.4582||95.0|-0.408|0.184|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.184|-0.408|0.4582
71047644|NCT00359788|141604254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.6538||95.0|-0.376|0.236|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.236|-0.376|0.6538
71047645|NCT00359788|141604255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.145||||0.4145||95.0|-0.495|0.205|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.205|-0.495|0.4145
71012907|NCT00798161|141533028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9|STANDARD_ERROR_OF_MEAN|4.1||0.0003||95.0|-22.9|-6.8|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-6.8|-22.9|0.0003
71012908|NCT00798161|141533028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001||95.0|-24.9|-8.8|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-8.8|-24.9|<0.0001
71047646|NCT00359788|141604256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.085||||0.6048||95.0|-0.408|0.238|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.238|-0.408|0.6048
70928737|NCT04800211|141353087|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-68.83||||0.0095|TWO_SIDED|95.0|-120.753|-16.907|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-16.907|-120.753|0.0095
71012909|NCT00798161|141533028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.5|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001||95.0|-29.5|-13.4|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-13.4|-29.5|<0.0001
71012910|NCT00798161|141533028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.6|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001||95.0|-33.6|-17.6|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-17.6|-33.6|<0.0001
71047647|NCT00359788|141604257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.3137||95.0|-0.503|0.162|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.162|-0.503|0.3137
71047648|NCT00359788|141604258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.061||||0.7195||95.0|-0.395|0.273|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.273|-0.395|0.7195
71047649|NCT00359788|141604259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.043||||0.7947||95.0|-0.367|0.282|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.282|-0.367|0.7947
71104033|NCT01346592|141715381|SUPERIORITY_OR_OTHER||Group difference (H1N1 strain)|17.7|||||TWO_SIDED|95.0|12.9|22.6||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||22.6|12.9|
71012911|NCT00798161|141533029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.9|STANDARD_ERROR_OF_MEAN|4.5|<|0.0001||95.0|-26.7|-9.1|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-9.1|-26.7|<0.0001
71012912|NCT00798161|141533029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|STANDARD_ERROR_OF_MEAN|4.5||0.0002||95.0|-25.6|-7.9|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-7.9|-25.6|0.0002
71012913|NCT00798161|141533029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.9|STANDARD_ERROR_OF_MEAN|4.5|<|0.0001||95.0|-36.7|-19.1|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-19.1|-36.7|<0.0001
71012914|NCT00798161|141533029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-37.6|STANDARD_ERROR_OF_MEAN|4.5|<|0.0001||95.0|-46.4|-28.8|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-28.8|-46.4|<0.0001
71012915|NCT00798161|141533030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.4|STANDARD_ERROR_OF_MEAN|4.7||0.0024||95.0|-23.7|-5.1|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-5.1|-23.7|0.0024
71012916|NCT00798161|141533030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.0|STANDARD_ERROR_OF_MEAN|4.8||0.0002||95.0|-27.4|-8.7|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-8.7|-27.4|0.0002
71012917|NCT00798161|141533030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.8|STANDARD_ERROR_OF_MEAN|4.7|<|0.0001||95.0|-37.1|-18.5|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-18.5|-37.1|<0.0001
71104034|NCT01346592|141715381|SUPERIORITY_OR_OTHER||Group difference (H3N2 strain)|5.6|||||TWO_SIDED|95.0|2.5|8.7||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||8.7|2.5|
71012918|NCT00798161|141533030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.5|STANDARD_ERROR_OF_MEAN|4.7|<|0.0001||95.0|-50.8|-32.2|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-32.2|-50.8|<0.0001
71012919|NCT00798161|141533031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.9|STANDARD_ERROR_OF_MEAN|4.8|<|0.0001||95.0|-30.4|-11.4|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-11.4|-30.4|<0.0001
71012920|NCT00798161|141533031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.9|STANDARD_ERROR_OF_MEAN|4.9||0.0003||95.0|-27.4|-8.3|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-8.3|-27.4|0.0003
71047650|NCT00359788|141604260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.093||||0.6049||95.0|-0.446|0.26|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.26|-0.446|0.6049
71047651|NCT00359788|141604261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.047||||0.8109||95.0|-0.437|0.342|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.342|-0.437|0.8109
71012921|NCT00798161|141533031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.4|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001||95.0|-35.0|-15.9|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-15.9|-35.0|<0.0001
71012922|NCT00798161|141533031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.0|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001||95.0|-48.5|-29.4|||ANCOVA|||Linagliptin 5 mg vs. Linagliptin 2.5 mg with Metformin 1000 mg||-29.4|-48.5|<0.0001
71012923|NCT00798161|141533032|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.372||||0.0062||95.0|1.278|4.402|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||4.402|1.278|0.0062
71047652|NCT00359788|141604262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.527||||0.1471||95.0|-0.186|1.24|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||1.24|-0.186|0.1471
71047653|NCT00359788|141604263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265||||0.3192||95.0|-0.258|0.788|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.788|-0.258|0.3192
71047654|NCT00359788|141604264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.351||||0.182||95.0|-0.165|0.867|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.867|-0.165|0.182
71104035|NCT01346592|141715381|SUPERIORITY_OR_OTHER||Group difference (B strain)|18.8|||||TWO_SIDED|95.0|14.4|23.1||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||23.1|14.4|
71012924|NCT00798161|141533032|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.163|||<|0.0001||95.0|2.343|7.397|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||7.397|2.343|<0.0001
71012925|NCT00798161|141533032|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.854|||<|0.0001||95.0|2.363|9.973|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||9.973|2.363|<0.0001
71047655|NCT00359788|141604265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.363||||0.1777||95.0|-0.166|0.893|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.893|-0.166|0.1777
71047656|NCT00359788|141604266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.363||||0.1805||95.0|-0.169|0.895|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.895|-0.169|0.1805
71047657|NCT00359788|141604267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.372||||0.1777||95.0|-0.17|0.913|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.913|-0.17|0.1777
71012926|NCT00798161|141533032|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.094|||<|0.0001||95.0|8.238|35.471|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||35.471|8.238|<0.0001
71012927|NCT00798161|141533034|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.465||||0.0102||95.0|1.342|8.943|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||8.943|1.342|0.0102
71012928|NCT00798161|141533034|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.521||||0.0004||95.0|1.747|7.094|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||7.094|1.747|0.0004
71012929|NCT00798161|141533034|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.521||||0.0053||95.0|1.564|13.069|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||13.069|1.564|0.0053
71047658|NCT00359788|141604268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159||||0.5725||95.0|-0.395|0.714|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.714|-0.395|0.5725
71047659|NCT00359788|141604269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121||||0.6765||95.0|-0.449|0.69|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.69|-0.449|0.6765
71047660|NCT00359788|141604270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.247||||0.3943||95.0|-0.323|0.818|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.818|-0.323|0.3943
71047661|NCT00359788|141604271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.291||||0.3091||95.0|-0.271|0.852|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.852|-0.271|0.3091
71047662|NCT00359788|141604272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.317||||0.2911||95.0|-0.273|0.907|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.907|-0.273|0.2911
71047663|NCT00359788|141604273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108||||0.7458||95.0|-0.549|0.766|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.766|-0.549|0.7458
71047664|NCT00359788|141604274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.698||||0.0004||95.0|4.836|16.56|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||16.56|4.836|0.0004
71047665|NCT00359788|141604275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.257||||0.0023||95.0|4.055|18.458|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||18.458|4.055|0.0023
71047666|NCT00359788|141604276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.772||||0.0015||95.0|4.942|20.602|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||20.602|4.942|0.0015
71104036|NCT01346592|141715382|SUPERIORITY_OR_OTHER||GMT Ratio (H1N1 strain)|2.38|||||TWO_SIDED|95.0|2.07|2.75||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||2.75|2.07|
71012930|NCT00798161|141533034|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.947|||<|0.0001||95.0|4.314|33.08|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||33.080|4.314|<0.0001
71047667|NCT00359788|141604277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.568||||0.0013||95.0|5.342|21.795|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||21.795|5.342|0.0013
71047668|NCT00359788|141604278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.052||||0.005||95.0|3.676|20.428|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||20.428|3.676|0.005
71047669|NCT00359788|141604279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.107||||0.0159||95.0|2.095|20.119|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||20.119|2.095|0.0159
71047670|NCT00359788|141604280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.057||||0.0219||95.0|1.613|20.501|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||20.501|1.613|0.0219
71047671|NCT00359788|141604281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.655||||0.0048||95.0|4.207|23.104|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||23.104|4.207|0.0048
71047672|NCT00359788|141604282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.231||||0.0058||95.0|4.153|24.31|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||24.31|4.153|0.0058
70928738|NCT04800211|141353087|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-1.593||||0.9586|TWO_SIDED|95.0|-61.873|58.687|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||58.687|-61.873|0.9586
70928739|NCT04800211|141353087|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.635||||0.9402|TWO_SIDED|95.0|-71.714|66.443|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||66.443|-71.714|0.9402
71012931|NCT00798161|141533036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.181|||<|0.0001||95.0|1.903|5.316|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||5.316|1.903|<0.0001
71104037|NCT01346592|141715382|SUPERIORITY_OR_OTHER||GMT Ratio (H3N2 strain)|1.88|||||TWO_SIDED|95.0|1.72|2.06||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||2.06|1.72|
71012932|NCT00798161|141533036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.382||||0.0027||95.0|1.352|4.196|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||4.196|1.352|0.0027
71012933|NCT00798161|141533036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.622|||<|0.0001||95.0|2.153|6.093|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||6.093|2.153|<0.0001
71012934|NCT00798161|141533036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.529|||<|0.0001||95.0|3.724|11.445|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||11.445|3.724|<0.0001
71012935|NCT00798161|141533037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|22.7||0.8893||95.0|-48.5|42.2|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||42.2|-48.5|0.8893
71012936|NCT00798161|141533037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.0|STANDARD_ERROR_OF_MEAN|22.1||0.3234||95.0|-66.2|22.2|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||22.2|-66.2|0.3234
71012937|NCT00798161|141533037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.8|STANDARD_ERROR_OF_MEAN|23.8||0.0373||95.0|-98.5|-3.1|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-3.1|-98.5|0.0373
71012938|NCT00798161|141533037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-73.9|STANDARD_ERROR_OF_MEAN|22.7||0.0018||95.0|-119.3|-28.6|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-28.6|-119.3|0.0018
71012939|NCT00798161|141533040|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.326||||0.0445|TWO_SIDED|95.0|0.109|0.973|||Regression, Logistic|||||0.973|0.109|0.0445
71012940|NCT00798161|141533040|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.274||||0.0151|TWO_SIDED|95.0|0.096|0.779|||Regression, Logistic|||||0.779|0.096|0.0151
71012941|NCT00798161|141533040|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42||||0.049|TWO_SIDED|95.0|0.177|0.996|||Regression, Logistic|||||0.996|0.177|0.0490
71012942|NCT00798161|141533040|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.598||||0.2617|TWO_SIDED|95.0|0.244|1.467|||Regression, Logistic|||||1.467|0.244|0.2617
71012943|NCT02706327|141533041|OTHER||||||<|0.001||||||A post-hoc test was used with Bonferroni correction and adjusted p-value was 0.016.|Kruskal-Wallis|Effect sizes (Cohen's d) were calculated for significant differences.||Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not. A post-hoc test was used with Bonferroni correction.||||<0.001
71012944|NCT02706327|141533042|OTHER|||||||0.547|||||||Kruskal-Wallis|||Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not.||||0.547
71012945|NCT02706327|141533043|OTHER|||||||0.895|||||||Kruskal-Wallis|||Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not.||||0.895
71012946|NCT02706327|141533044|OTHER|||||||0.842|||||||Kruskal-Wallis|||Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not.||||0.842
71012947|NCT02706327|141533045|OTHER|||||||0.848|||||||Kruskal-Wallis|||Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not.||||0.848
70928740|NCT04800211|141353087|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-113.663||||0.039|TWO_SIDED|95.0|-223.33|-3.996|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-3.996|-223.330|0.0390
70928741|NCT04800211|141353087|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-72.269||||0.4543|TWO_SIDED|95.0|-199.091|54.554|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||54.554|-199.091|0.4543
70928742|NCT04800211|141353087|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-142.442||||0.0051|TWO_SIDED|95.0|-252.08|-32.805|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-32.805|-252.080|0.0051
70928743|NCT04800211|141353087|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-60.12||||0.6061|TWO_SIDED|95.0|-184.286|64.046|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||64.046|-184.286|0.6061
71012948|NCT03417245|141533078|SUPERIORITY||ABR ratio|0.101|||<|0.0001|TWO_SIDED|95.0|0.064|0.159||P-value derived from NB regression model during EP, with treatment arm, number of bleeds in 6 months prior to study (\<=10, \>10) and hemophilia type (A vs B) as fixed effects. Significance threshold was at 0.05.|Negative binomial regression mode|||||0.159|0.064|<0.0001
71012949|NCT03417245|141533080|SUPERIORITY||ABR ratio|0.13|||<|0.0001|TWO_SIDED|95.0|0.09|0.188||P-value derived from NB regression model during TP, with treatment arm, number of bleeds in 6 months prior to study (\<=10, \>10) and hemophilia type (A vs B) as fixed effects. Significance threshold was at 0.05.|Negative binomial regression model|||||0.188|0.090|<0.0001
71012950|NCT03417245|141533082|SUPERIORITY||ABR ratio|0.083|||<|0.0001|TWO_SIDED|95.0|0.049|0.141||P-value derived from NB regression model during EP, with treatment arm, number of bleeds in 6 months prior to study (\<=10, \>10) and hemophilia type (A vs B) as fixed effects. Significance threshold was at 0.05.|Negative binomial regression model|||||0.141|0.049|<0.0001
71012951|NCT03417245|141533084|SUPERIORITY||ABR ratio|0.097|||<|0.0001|TWO_SIDED|95.0|0.059|0.161||P-value derived from NB regression model during EP, with treatment arm, number of bleeds in 6 months prior to study (\<=10, \>10) and hemophilia type (A vs B) as fixed effects. Significance threshold was at 0.05.|Negative binomial regression model|||||0.161|0.059|<0.0001
71104038|NCT01346592|141715382|SUPERIORITY_OR_OTHER||GMT Ratio (B strain)|2.93|||||TWO_SIDED|95.0|2.6|3.3||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||3.3|2.6|
71012952|NCT03417245|141533086|SUPERIORITY||Least Square (LS) Mean difference|-19.75|||<|0.0001|TWO_SIDED|95.0|-27.0|-12.5||Analysis of Covariance (ANCOVA) model included treatment arm, number of bleeds in 6 months prior to study (\<=10,\>10) and hemophilia type (A vs B) as fixed effects, Baseline score as covariate. Significance threshold was at 0.05.|ANCOVA|||||-12.50|-27.00|<0.0001
71012953|NCT03417245|141533087|SUPERIORITY||LS Mean difference|-7.07|||=|0.0011|TWO_SIDED|95.0|-11.23|-2.9||ANCOVA model included treatment arm, number of bleeds in 6 months prior to study (\<=10,\>10) and hemophilia type (A vs B) as fixed effects, Baseline score as covariate. Significance threshold was at 0.05.|ANCOVA|||||-2.90|-11.23|=0.0011
71012954|NCT03781167|141533179|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
71104039|NCT01346592|141715382|SUPERIORITY_OR_OTHER||GMT Ratio (H1N1 strain)|3.21|||||TWO_SIDED|95.0|2.79|3.71||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||3.71|2.79|
71012955|NCT03781167|141533179|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
70928744|NCT04800211|141353087|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-66.194||||0.1242|TWO_SIDED|95.0|-150.672|18.284|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||18.284|-150.672|0.1242
70928745|NCT04800211|141353087|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-12.149||||0.8117|TWO_SIDED|95.0|-112.35|88.052|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||88.052|-112.350|0.8117
70928746|NCT04800211|141353088|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-111.957||||0.0567|TWO_SIDED|95.0|-227.151|3.237|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.237|-227.151|0.0567
70941417|NCT02567227|141383500|SUPERIORITY||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-1.04|1.85|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the mental health score of the SF-12 pre and post intervention.||1.85|-1.04|
71012956|NCT03781167|141533179|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
71012957|NCT03781167|141533179|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71012958|NCT03781167|141533179|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71012959|NCT03781167|141533179|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71012960|NCT03781167|141533179|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71012961|NCT03781167|141533179|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71012962|NCT03781167|141533179|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71012963|NCT03781167|141533179|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71012964|NCT03781167|141533179|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71012965|NCT03781167|141533179|SUPERIORITY|Week 26 vs Baseline|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71012966|NCT03781167|141533179|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71012967|NCT03781167|141533179|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71047673|NCT00359788|141604283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.597||||0.0248||95.0|1.483|21.71|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||21.71|1.483|0.0248
71012968|NCT03781167|141533179|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71012969|NCT03781167|141533179|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71012970|NCT03781167|141533179|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71012971|NCT03781167|141533179|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71012972|NCT03781167|141533180|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||>|0.999|||||||paired-sample t-test|||Week 1 vs Baseline||||>0.999
70928747|NCT04800211|141353088|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-76.728||||0.2103|TWO_SIDED|95.0|-197.025|43.569|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||43.569|-197.025|0.2103
71012973|NCT03781167|141533180|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.5095|||||||paired-sample t-test|||Week 1 vs Baseline||||=0.5095
70928748|NCT04800211|141353088|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-169.735||||0.0052|TWO_SIDED|95.0|-288.22|-51.251|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-51.251|-288.220|0.0052
70928749|NCT04800211|141353088|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-52.505||||0.349|TWO_SIDED|95.0|-162.721|57.711|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||57.711|-162.721|0.3490
71012974|NCT03781167|141533180|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.6962|||||||paired-sample t-test|||Week 1 vs Baseline||||=0.6962
71012975|NCT03781167|141533180|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0035|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.0035
71012976|NCT03781167|141533180|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0324|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.0324
71012977|NCT03781167|141533180|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71012978|NCT03781167|141533180|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0072|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.0072
71012979|NCT03781167|141533180|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0129|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.0129
71012980|NCT03781167|141533180|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71012981|NCT03781167|141533180|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0119|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.0119
71047674|NCT00359788|141604284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.001||||0.0325||95.0|0.924|21.079|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||21.079|0.924|0.0325
71047675|NCT00359788|141604285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.074||||0.0153||95.0|2.726|25.422|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||25.422|2.726|0.0153
71012982|NCT03781167|141533180|SUPERIORITY||||||=|0.22||||||A paired-sample t-test was performed to test the change from Baseline.|paired-sample t-test|||Week 26 vs Baseline||||=0.2200
71012983|NCT03781167|141533180|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0063|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.0063
71012984|NCT03781167|141533180|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71012985|NCT03781167|141533180|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.4331|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.4331
71012986|NCT03781167|141533180|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0045|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.0045
71012987|NCT03781167|141533180|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0049|||||||Wilcoxon (Mann-Whitney)|||Week 52 vs Baseline||||=0.0049
71012988|NCT03781167|141533180|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.6312|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.6312
70928750|NCT04800211|141353088|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-11.413||||0.841|TWO_SIDED|95.0|-123.333|100.507|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||100.507|-123.333|0.8410
70941418|NCT02498418|141383515|EQUIVALENCE|Bioequivalence was demonstrated if 90% confidence interval (CI) of percentage difference between generic rifaximin 200 mg tablets and xifaxan 200 mg tablets was within the equivalence range (-20%, +20%).|Difference in percentage of participants|-0.0193|||||TWO_SIDED|90.0|-0.11|0.07||||||Bioequivalence was evaluated based on the PP analysis set using Z-test with Yates correction.||0.07|-0.11|
71012989|NCT03781167|141533180|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.1892|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.1892
71012990|NCT03781167|141533181|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
71012991|NCT03781167|141533181|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
71012992|NCT03781167|141533181|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
71012993|NCT03781167|141533181|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71012994|NCT03781167|141533181|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71012995|NCT03781167|141533181|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71012996|NCT03781167|141533181|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71012997|NCT03781167|141533181|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71012998|NCT03781167|141533181|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71012999|NCT03781167|141533181|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71013000|NCT03781167|141533181|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71013001|NCT03781167|141533181|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71013002|NCT03781167|141533181|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71013003|NCT03781167|141533181|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71013004|NCT03781167|141533181|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71013005|NCT03781167|141533181|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71013006|NCT03781167|141533181|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71013007|NCT03781167|141533181|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71013008|NCT03781167|141533182|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
71013009|NCT03781167|141533182|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
71013010|NCT03781167|141533182|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
71013011|NCT03781167|141533182|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
71013012|NCT03781167|141533182|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
71013013|NCT03781167|141533182|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
71013014|NCT03781167|141533182|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
71013015|NCT03781167|141533182|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
71047676|NCT00359788|141604286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.755||||0.6105||95.0|-8.532|5.022|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||5.022|-8.532|0.6105
71047677|NCT00359788|141604287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.842||||0.8249||95.0|-6.642|8.326|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||8.326|-6.642|0.8249
71047678|NCT00359788|141604288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.71||||0.4896||95.0|-5.001|10.421|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||10.421|-5.001|0.4896
71013016|NCT03781167|141533182|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
70928751|NCT04800211|141353088|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-53.565||||0.3465|TWO_SIDED|95.0|-165.4|58.27|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||58.270|-165.400|0.3465
70928752|NCT04800211|141353088|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-111.65||||0.0087|TWO_SIDED|95.0|-194.865|-28.435|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-28.435|-194.865|0.0087
70941419|NCT02498418|141383518|SUPERIORITY||Difference in percentage of participants|-0.0195||||0.7899|TWO_SIDED|95.0|-0.09|0.13||Threshold of significance at 0.05 level.|Z-test|||95% CIs was calculated using Z-test with Yates' correction.||0.13|-0.09|0.7899
70941420|NCT02498418|141383518|SUPERIORITY||Difference in percentage of participants|0.033||||0.5987|TWO_SIDED|95.0|-0.07|0.14||Threshold for significance at 0.05 level.|Z-test|||95% CIs was calculated using Z-test with Yates' correction.||0.14|-0.07|0.5987
71013017|NCT03781167|141533182|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
71013018|NCT03781167|141533182|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
71013019|NCT03781167|141533182|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
71013020|NCT03781167|141533182|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0042|||||||paired-sample t-test|||Week 4 vs Baseline||||=0.0042
71104040|NCT01346592|141715382|SUPERIORITY_OR_OTHER||GMT Ratio (H3N2 strain)|2.4|||||TWO_SIDED|95.0|2.19|2.62||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||2.62|2.19|
71104041|NCT01346592|141715382|SUPERIORITY_OR_OTHER||GMT Ratio (B strain)|3.08|||||TWO_SIDED|95.0|2.73|3.47||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||3.47|2.73|
71013021|NCT03781167|141533182|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
71013022|NCT03781167|141533182|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
71013023|NCT03781167|141533182|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.1135|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.1135
71013024|NCT03781167|141533182|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0029|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.0029
71013025|NCT03781167|141533182|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0026|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.0026
71013026|NCT03781167|141533182|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0034|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.0034
71013027|NCT03781167|141533182|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0103|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.0103
71013028|NCT03781167|141533182|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71013029|NCT03781167|141533182|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0493|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.0493
71013030|NCT03781167|141533182|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.3003|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.3003
71013031|NCT03781167|141533182|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0354|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.0354
71013032|NCT03781167|141533182|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2553|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.2553
71013033|NCT03781167|141533182|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.864|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.8640
71013034|NCT03781167|141533182|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.4774|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.4774
71104042|NCT01346592|141715383|SUPERIORITY_OR_OTHER||Group difference (H1N1 strain)|9.3|||||TWO_SIDED|95.0|6.3|12.4||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||12.4|6.3|
71013035|NCT03781167|141533182|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.3865|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.3865
71013036|NCT03781167|141533182|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.||||||0.1186|||||||paired-sample t-test|||Week 52 vs Baseline||||0.1186
71013037|NCT03781167|141533182|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.083|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.0830
71013038|NCT03781167|141533183|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
71013039|NCT03781167|141533183|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0041|||||||paired-sample t-test|||Day 2 vs Baseline||||=0.0041
71013040|NCT03781167|141533183|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
71013041|NCT03781167|141533183|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
71013042|NCT03781167|141533183|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
71013043|NCT03781167|141533183|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
71013044|NCT03781167|141533183|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
71013045|NCT03781167|141533183|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
71013046|NCT03781167|141533183|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
71013047|NCT03781167|141533183|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
71013048|NCT03781167|141533183|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
71013049|NCT03781167|141533183|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
71013050|NCT03781167|141533183|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
71013051|NCT03781167|141533183|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
71013052|NCT03781167|141533183|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
71013053|NCT03781167|141533183|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71013054|NCT03781167|141533183|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71013055|NCT03781167|141533183|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71013056|NCT03781167|141533183|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71013057|NCT03781167|141533183|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71013058|NCT03781167|141533183|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71013059|NCT03781167|141533183|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71013060|NCT03781167|141533183|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71013061|NCT03781167|141533183|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71013062|NCT03781167|141533183|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71013063|NCT03781167|141533183|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71013064|NCT03781167|141533183|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71013065|NCT03781167|141533183|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0091|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.0091
71013066|NCT03781167|141533183|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71013067|NCT03781167|141533183|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71013068|NCT03781167|141533184|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.4447|||||||paired-sample t-test|||Day 2 vs Baseline||||=0.4447
71013069|NCT03781167|141533184|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.3567|||||||paired-sample t-test|||Day 2 vs Baseline||||=0.3567
71013070|NCT03781167|141533184|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2315|||||||paired-sample t-test|||Day 2 vs Baseline||||=0.2315
71013071|NCT03781167|141533184|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0667|||||||paired-sample t-test|||Week 1 vs Baseline||||=0.0667
71013072|NCT03781167|141533184|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
71013073|NCT03781167|141533184|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
71047679|NCT00359788|141604289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.898||||0.0935||95.0|-1.172|14.968|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||14.968|-1.172|0.0935
71013074|NCT03781167|141533184|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
71013075|NCT03781167|141533184|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2033|||||||paired-sample t-test|||Week 2 vs Baseline||||=0.2033
71013076|NCT03781167|141533184|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
71013077|NCT03781167|141533184|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0012|||||||paired-sample t-test|||Week 3 vs Baseline||||=0.0012
71013078|NCT03781167|141533184|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0734|||||||paired-sample t-test|||Week 3 vs Baseline||||=0.0734
71013079|NCT03781167|141533184|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
71013080|NCT03781167|141533184|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0304|||||||paired-sample t-test|||Week 4 vs Baseline||||=0.0304
71013081|NCT03781167|141533184|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||>|0.999|||||||paired-sample t-test|||Week 4 vs Baseline||||>0.999
71013082|NCT03781167|141533184|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0891|||||||paired-sample t-test|||Week 4 vs Baseline||||=0.0891
71013083|NCT03781167|141533184|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0832|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.0832
71013084|NCT03781167|141533184|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.4941|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.4941
71013085|NCT03781167|141533184|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2764|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.2764
71013086|NCT03781167|141533184|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.3248|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.3248
71047680|NCT00359788|141604290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.419||||0.4339||95.0|-5.17|12.007|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||12.007|-5.17|0.4339
71013087|NCT03781167|141533184|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2535|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.2535
71013088|NCT03781167|141533184|OTHER|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.9274|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.9274
71013089|NCT03781167|141533184|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.3297|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.3297
71013090|NCT03781167|141533184|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.9722|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.9722
71013091|NCT03781167|141533184|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.4403|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.4403
71013092|NCT03781167|141533184|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.1946|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.1946
71013093|NCT03781167|141533184|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2077|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.2077
71013094|NCT03781167|141533184|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0692|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.0692
71013095|NCT03781167|141533184|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2276|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.2276
71047681|NCT00359788|141604291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.971||||0.845||95.0|-10.74|8.799|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||8.799|-10.74|0.845
71047682|NCT00359788|141604292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.194||||0.9696||95.0|-9.811|10.199|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||10.199|-9.811|0.9696
71047683|NCT00359788|141604293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.129||||0.3252||95.0|-5.117|15.376|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||15.376|-5.117|0.3252
71013096|NCT03781167|141533184|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.||||||0.3369|||||||paired-sample t-test|||Week 52 vs Baseline||||0.3369
71013097|NCT03781167|141533184|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.1218|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.1218
71013098|NCT03781167|141533185|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
71013099|NCT03781167|141533185|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.002|||||||paired-sample t-test|||Day 2 vs Baseline||||=0.0020
71013100|NCT03781167|141533185|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
71013101|NCT03781167|141533185|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
71013102|NCT03781167|141533185|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
71047684|NCT00359788|141604294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.062||||0.452||95.0|-6.558|14.683|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||14.683|-6.558|0.452
71047685|NCT00359788|141604295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.14||||0.4388||95.0|-6.372|14.651|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||14.651|-6.372|0.4388
71047686|NCT00359788|141604296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.185||||0.8288||95.0|-9.595|11.964|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||11.964|-9.595|0.8288
71047687|NCT00359788|141604297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.204||||0.4929||95.0|-7.857|16.264|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||16.264|-7.857|0.4929
71047688|NCT00359788|141604298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.204||||0.0754||95.0|-0.021|0.429|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.429|-0.021|0.0754
71047689|NCT00359788|141604299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251||||0.0765||95.0|-0.027|0.528|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.528|-0.027|0.0765
71047690|NCT00359788|141604300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151||||0.163||95.0|-0.061|0.363|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.363|-0.061|0.163
71047691|NCT00359788|141604301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.285||||0.0085||95.0|0.073|0.496|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.496|0.073|0.0085
71047692|NCT04932941|141604310|SUPERIORITY||Common risk difference|-0.276||||0.962|TWO_SIDED|95.0|-11.634|11.081|||Mantel Haenszel||Strata-adjusted Mantel Haenszel (MH) method for difference in proportions controlling for stratification factors (COVID-19 severity: moderate, severe, and age group: less than or equal to 65 years, greater than 65 years).|||11.081|-11.634|0.962
71047693|NCT01929031|141604337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.738|STANDARD_ERROR_OF_MEAN|4.058|<|0.0001|TWO_SIDED|95.0|33.767|49.708|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Placebo|||49.708|33.767|<0.0001
71047694|NCT01929031|141604337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.467|STANDARD_ERROR_OF_MEAN|4.058|<|0.0001|TWO_SIDED|95.0|28.497|44.437|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Caffeine|||44.437|28.497|<0.0001
71104043|NCT01346592|141715383|SUPERIORITY_OR_OTHER||Group difference (H3N2 strain)|3.9|||||TWO_SIDED|95.0|1.8|5.9||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||5.9|1.8|
71047695|NCT01929031|141604337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.126|STANDARD_ERROR_OF_MEAN|2.868|<|0.0001|TWO_SIDED|95.0|6.493|17.759|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Ibuprofen|||17.759|6.493|<0.0001
71047696|NCT01929031|141604338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.525|STANDARD_ERROR_OF_MEAN|0.808|<|0.0001|TWO_SIDED|95.0|6.937|10.113|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Placebo|||10.113|6.937|<0.0001
71047697|NCT01929031|141604338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.972|STANDARD_ERROR_OF_MEAN|0.808|<|0.0001|TWO_SIDED|95.0|6.384|9.559|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Caffeine|||9.559|6.384|<0.0001
71047698|NCT01929031|141604338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.594|STANDARD_ERROR_OF_MEAN|0.571|<|0.0001|TWO_SIDED|95.0|2.472|4.716|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Ibuprofen|||4.716|2.472|<0.0001
71047699|NCT01929031|141604339|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Placebo||||<0.0001
71047700|NCT01929031|141604339|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Caffeine||||<0.0001
71047701|NCT01929031|141604339|SUPERIORITY_OR_OTHER|||||||0.2389|TWO_SIDED||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Ibuprofen||||0.2389
71047702|NCT01929031|141604340|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Placebo||||<0.0001
71047703|NCT01929031|141604340|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Caffeine||||<0.0001
71104044|NCT01346592|141715383|SUPERIORITY_OR_OTHER||Group difference (B strain)|10.7|||||TWO_SIDED|95.0|8.1|13.3||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||13.3|8.1|
71047704|NCT01929031|141604340|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Ibuprofen||||0.0001
71047705|NCT00321594|141604341|OTHER||Maximum Tolerated Dose|1400.0|||||TWO_SIDED||||||||MTD was not reached and the maximum dose of 1400 mg/m2 is used in Phase II portion|MTD is defined as the dose below which \>=2 of 3 or \>= 2 of 6 patients experience DLT||||
71047706|NCT01195272|141604366|SUPERIORITY_OR_OTHER|||||||0.308|||||||t-test, 2 sided|||4 hrs: Visit 3 versus Visit 2||||0.308
71047707|NCT01195272|141604366|SUPERIORITY_OR_OTHER|||||||0.415|||||||t-test, 2 sided|||4 hrs: Visit 5 versus Visit 2||||0.415
71047708|NCT01195272|141604366|SUPERIORITY_OR_OTHER|||||||0.335|||||||t-test, 2 sided|||4 hrs: Visit 5 versus Visit 3||||0.335
71047709|NCT01195272|141604366|SUPERIORITY_OR_OTHER|||||||0.12|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 2||||0.120
71047710|NCT01195272|141604366|SUPERIORITY_OR_OTHER|||||||0.061|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 3||||0.061
71047711|NCT01195272|141604366|SUPERIORITY_OR_OTHER|||||||0.031|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 5||||0.031
71047712|NCT01195272|141604366|SUPERIORITY_OR_OTHER|||||||0.131|||||||t-test, 2 sided|||20 hrs: Visit 3 versus Visit 2||||0.131
71047713|NCT01195272|141604366|SUPERIORITY_OR_OTHER|||||||0.202|||||||t-test, 2 sided|||20 hrs: Visit 5 versus Visit 2||||0.202
71047714|NCT01195272|141604366|SUPERIORITY_OR_OTHER|||||||0.484|||||||t-test, 2 sided|||20 hrs: Visit 5 versus Visit 3||||0.484
71013103|NCT03781167|141533185|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
71013104|NCT03781167|141533185|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
71013105|NCT03781167|141533185|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
71013106|NCT03781167|141533185|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
71013107|NCT03781167|141533185|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
71013108|NCT03781167|141533185|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
71013109|NCT03781167|141533185|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
71013110|NCT03781167|141533185|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
71013111|NCT03781167|141533185|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
71013112|NCT03781167|141533185|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
71013113|NCT03781167|141533185|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71013114|NCT03781167|141533185|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71013115|NCT03781167|141533185|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71013116|NCT03781167|141533185|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71013117|NCT03781167|141533185|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71013118|NCT03781167|141533185|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71013119|NCT03781167|141533185|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71013120|NCT03781167|141533185|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71013121|NCT03781167|141533185|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71013122|NCT03781167|141533185|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71013123|NCT03781167|141533185|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71013124|NCT03781167|141533185|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71013125|NCT03781167|141533185|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71013126|NCT03781167|141533185|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71013127|NCT03781167|141533185|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71047715|NCT01195272|141604366|SUPERIORITY_OR_OTHER|||||||0.047|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 2||||0.047
71047716|NCT01195272|141604366|SUPERIORITY_OR_OTHER|||||||0.285|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 3||||0.285
71047717|NCT01195272|141604366|SUPERIORITY_OR_OTHER|||||||0.315|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 5||||0.315
71013128|NCT03781167|141533186|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71013129|NCT03781167|141533186|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71013130|NCT03781167|141533186|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71013131|NCT03781167|141533186|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71013132|NCT03781167|141533186|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71013133|NCT03781167|141533186|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71013134|NCT03781167|141533186|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71013135|NCT03781167|141533186|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71013136|NCT03781167|141533186|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71013137|NCT03781167|141533186|OTHER|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71013138|NCT03781167|141533186|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71013139|NCT03781167|141533186|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71047718|NCT01195272|141604367|SUPERIORITY_OR_OTHER|||||||0.288|||||||t-test, 2 sided|||4 hrs: Visit 3 versus Visit 2||||0.288
71047719|NCT01195272|141604367|SUPERIORITY_OR_OTHER|||||||0.318|||||||t-test, 2 sided|||4 hrs: Visit 5 versus Visit 2||||0.318
71104045|NCT01346592|141715383|SUPERIORITY_OR_OTHER||Group difference (H1N1 strain)|14.4|||||TWO_SIDED|95.0|11.1|17.7||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||17.7|11.1|
71104046|NCT01346592|141715383|SUPERIORITY_OR_OTHER||Group difference (H3N2 strain)|6.8|||||TWO_SIDED|95.0|4.5|9.1||||||superiority was concluded if the lower bound of 95% CI of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||9.1|4.5|
71013140|NCT03781167|141533186|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71013141|NCT03781167|141533186|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71013142|NCT03781167|141533186|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71013143|NCT03781167|141533187|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71013144|NCT03781167|141533187|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71013145|NCT03781167|141533187|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71013146|NCT03781167|141533187|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71013147|NCT03781167|141533187|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71013148|NCT03781167|141533187|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71013149|NCT03781167|141533187|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71013150|NCT03781167|141533187|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71013151|NCT03781167|141533187|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71013152|NCT03781167|141533187|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71013153|NCT03781167|141533187|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71013154|NCT03781167|141533187|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71013155|NCT03781167|141533187|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71013156|NCT03781167|141533187|OTHER|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71013157|NCT03781167|141533187|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71013158|NCT03781167|141533188|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0035|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.0035
71013159|NCT03781167|141533188|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71013160|NCT03781167|141533188|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71047720|NCT01195272|141604367|SUPERIORITY_OR_OTHER|||||||0.4|||||||t-test, 2 sided|||4 hrs: Visit 5 versus Visit 3||||0.400
71047721|NCT01195272|141604367|SUPERIORITY_OR_OTHER|||||||0.317|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 2||||0.317
71047722|NCT01195272|141604367|SUPERIORITY_OR_OTHER|||||||0.137|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 3||||0.137
70941421|NCT03042559|141383523|SUPERIORITY|||||||||||||a priori threshold for statistical significance is \<0.05.|Wilcoxon (Mann-Whitney)|||Data analysis was performed using SPSS Statistics Software version 24.0. We compared mean age (years), Body Mass Index (kg/m2) (BMI), pain duration, and the outcome measures at baseline in both groups at baseline using independent t-test when the distribution of the variable was approximately normal and Mann-Whitney test when the distribution was not normal. The distribution of qualitative variables (gender, affected leg) by group type was examined using Chi Square test.|a priori threshold for statistical significance is \<0.05.|||
71013161|NCT03781167|141533188|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0098|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.0098
71013162|NCT03781167|141533188|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71013163|NCT03781167|141533188|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71013164|NCT03781167|141533188|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71013165|NCT03781167|141533188|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71013166|NCT03781167|141533188|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71013167|NCT03781167|141533188|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71047723|NCT01195272|141604367|SUPERIORITY_OR_OTHER|||||||0.052|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 5||||0.052
71047724|NCT01195272|141604367|SUPERIORITY_OR_OTHER|||||||0.354|||||||t-test, 2 sided|||20 hrs: Visit 3 versus Visit 2||||0.354
71047725|NCT01195272|141604367|SUPERIORITY_OR_OTHER|||||||0.266|||||||t-test, 2 sided|||20 hrs: Visit 5 versus Visit 2||||0.266
71047726|NCT01195272|141604367|SUPERIORITY_OR_OTHER|||||||0.378|||||||t-test, 2 sided|||20 hrs: Visit 5 versus Visit 3||||0.378
71013168|NCT03781167|141533188|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71013169|NCT03781167|141533188|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71013170|NCT03781167|141533188|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.003|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.0030
71013171|NCT03781167|141533188|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71013172|NCT03781167|141533188|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71013173|NCT00398476|141533242|OTHER|||||||0.003|||||||Cochran-Mantel-Haenszel|||Analysis for overall product preference||||0.003
71013174|NCT00398476|141533242|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Analysis for Scent/odor||||<0.001
71013175|NCT00398476|141533242|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Analysis for Immediate taste||||<0.001
71013176|NCT00398476|141533242|OTHER|||||||0.002|||||||Cochran-Mantel-Haenszel|||Analysis for After-taste||||0.002
71013177|NCT00398476|141533242|OTHER|||||||0.037|||||||Cochran-Mantel-Haenszel|||Analysis for Less drip down throat||||0.037
71013178|NCT00398476|141533242|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Analysis for Less run out nose||||<0.001
71013179|NCT00398476|141533242|OTHER|||||||0.408|||||||Cochran-Mantel-Haenszel|||Analysis for More soothing||||0.408
71013180|NCT00398476|141533242|OTHER|||||||0.07|||||||Cochran-Mantel-Haenszel|||Analysis for Less irritating||||0.070
71013181|NCT00398476|141533242|OTHER|||||||0.587|||||||Cochran-Mantel-Haenszel|||Analysis for Urge to sneeze||||0.587
71013182|NCT00398476|141533243|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Final Values)|-2.0|||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg for IAQ items||||<0.001
71013183|NCT00398476|141533243|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Final Values)|-1.0|||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg for DAQ items||||<0.001
71013184|NCT00398476|141533244|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Net)|0.0||||0.255||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg in IAQ||||0.255
71013185|NCT00398476|141533245|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Net)|0.0||||0.056||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg for all DAQ items||||0.056
71013186|NCT00398476|141533246|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.845||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg for IAQ Irtems||||0.845
71047727|NCT01195272|141604367|SUPERIORITY_OR_OTHER|||||||0.422|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 2||||0.422
71047728|NCT01195272|141604367|SUPERIORITY_OR_OTHER|||||||0.444|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 3||||0.444
71047729|NCT01195272|141604367|SUPERIORITY_OR_OTHER|||||||0.345|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 5||||0.345
71047730|NCT01195272|141604368|SUPERIORITY_OR_OTHER|||||||0.39|||||||ANOVA|||Visit 3 versus Visit 2||||0.39
71047731|NCT01195272|141604368|SUPERIORITY_OR_OTHER|||||||0.08|||||||ANOVA|||Visit 5 versus Visit 3||||0.08
71047732|NCT01195272|141604368|SUPERIORITY_OR_OTHER|||||||0.18|||||||ANOVA|||Visit 5 versus Visit 3||||0.18
71047733|NCT01195272|141604369|SUPERIORITY_OR_OTHER|||||||0.48|||||||ANOVA|||Visit 3 versus Visit 2||||0.48
71104047|NCT01346592|141715383|SUPERIORITY_OR_OTHER||Group difference (B strain)|10.9|||||TWO_SIDED|95.0|8.3|13.4||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||13.4|8.3|
71013187|NCT00398476|141533247|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.871||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg for DAQ Items||||0.871
71013188|NCT00398476|141533248|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0|||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
71013189|NCT00398476|141533249|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.592||95.0|||||Cochran-Mantel-Haenszel|||||||0.592
71013190|NCT00398476|141533250|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Net)|0.0|||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
71013191|NCT00398476|141533251|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.434||95.0|||||Cochran-Mantel-Haenszel|||||||0.434
71013192|NCT00398476|141533252|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.797|||||||Cochran-Mantel-Haenszel|||This analysis is for IAQ||||0.797
71013193|NCT00398476|141533252|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.296|||||||Cochran-Mantel-Haenszel|||This analysis is for DAQ||||0.296
71013194|NCT00398476|141533253|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0|||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg in IAQ||||<0.001
71013195|NCT00398476|141533253|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0|||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg in DAQ||||<0.001
71013196|NCT00398476|141533254|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.968|||||||Cochran-Mantel-Haenszel|||This analysis is for IAQ||||0.968
71013197|NCT00398476|141533254|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Mean Difference (Net)|0.0||||0.797|||||||Cochran-Mantel-Haenszel|||This analysis is for DAQ||||0.797
71013198|NCT00398476|141533255|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.221|||||||Cochran-Mantel-Haenszel|||||||0.221
71013199|NCT00398476|141533256|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.205|||||||Cochran-Mantel-Haenszel|||||||0.205
71013200|NCT00398476|141533257|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Net)|0.0||||0.108|||||||Cochran-Mantel-Haenszel|||||||0.108
71013201|NCT00398476|141533258|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.694|||||||Cochran-Mantel-Haenszel|||||||0.694
71013202|NCT00398476|141533259|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.02|||||||Cochran-Mantel-Haenszel|||||||0.020
71013203|NCT02369874|141533332|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.7624|TWO_SIDED|95.0|0.85|1.26|||Log Rank|||||1.26|0.85|0.7624
71013204|NCT02369874|141533332|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1993|TWO_SIDED|95.0|0.72|1.08|||Log Rank|||||1.08|0.72|0.1993
71104048|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT Ratio (H1N1 strain)|2.68|||||TWO_SIDED|95.0|2.3|3.12||||||No risk subjects.||3.12|2.3|
71013205|NCT02369874|141533333|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.459|TWO_SIDED|95.0|0.73|1.17|||Log Rank|||||1.17|0.73|0.4590
71013206|NCT02369874|141533333|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.85|1.36||||||||1.36|0.85|
71013207|NCT02369874|141533334|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.63|1.39||||||||1.39|0.63|
71013208|NCT02369874|141533335|SUPERIORITY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.9|1.33||||||||1.33|0.90|
71013209|NCT02369874|141533335|SUPERIORITY||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.84|1.25||||||||1.25|0.84|
71013210|NCT02369874|141533336|SUPERIORITY||Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.67|1.7||||||||1.70|0.67|
71013211|NCT02369874|141533336|SUPERIORITY||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.66|1.68||||||||1.68|0.66|
71013212|NCT02369874|141533338|SUPERIORITY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.67|1.52||||||6 Month analysis||1.52|0.67|
71013213|NCT02369874|141533338|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.64|1.46||||||6 Month analysis||1.46|0.64|
71047734|NCT01195272|141604369|SUPERIORITY_OR_OTHER|||||||0.3|||||||ANOVA|||Visit 5 versus Visit 2||||0.30
71047735|NCT01195272|141604369|SUPERIORITY_OR_OTHER|||||||0.34|||||||ANOVA|||Visit 5 versus Visit 3||||0.34
71104049|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT Ratio (H3N2 strain)|1.87|||||TWO_SIDED|95.0|1.7|2.05||||||No risk subjects.||2.05|1.7|
71104050|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.04|||||TWO_SIDED|95.0|2.68|3.44||||||No risk subjects.||3.44|2.68|
71047736|NCT01195272|141604370|SUPERIORITY_OR_OTHER|||||||0.22|||||||ANOVA|||Visit 3 versus Visit 2||||0.22
71047737|NCT01195272|141604370|SUPERIORITY_OR_OTHER|||||||0.44|||||||ANOVA|||Visit 5 versus Visit 2||||0.44
71047738|NCT01195272|141604370|SUPERIORITY_OR_OTHER|||||||0.23|||||||ANOVA|||Visit 5 versus Visit 3||||0.23
71047739|NCT01195272|141604371|SUPERIORITY_OR_OTHER|||||||0.22|||||||ANOVA|||Visit 3 versus Visit 2||||0.22
71047740|NCT01195272|141604371|SUPERIORITY_OR_OTHER|||||||0.46|||||||ANOVA|||Visit 5 versus Visit 2||||0.46
71047741|NCT01195272|141604371|SUPERIORITY_OR_OTHER|||||||0.24|||||||ANOVA|||Visit 5 versus Visit 3||||0.24
71047742|NCT01195272|141604372|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||Visit 3 versus Visit 2||||0.05
71047743|NCT01195272|141604372|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANOVA|||Visit 5 versus Visit 2||||0.01
71047744|NCT01195272|141604372|SUPERIORITY_OR_OTHER|||||||0.18|||||||ANOVA|||Visit 5 versus Visit 3||||0.18
71047745|NCT01195272|141604373|SUPERIORITY_OR_OTHER|||||||0.48|||||||ANOVA|||Visit 3 versus Visit 2||||0.48
71104051|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.21|||||TWO_SIDED|95.0|1.11|4.42||||||At risk subjects.||4.42|1.11|
70941422|NCT03042559|141383530|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71013214|NCT02369874|141533338|SUPERIORITY||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.72|1.75||||||12 Month analysis||1.75|0.72|
71013215|NCT02369874|141533338|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.63|1.57||||||12 Month analysis||1.57|0.63|
71013216|NCT02369874|141533341|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.76|1.21||||||||1.21|0.76|
71013217|NCT02369874|141533342|SUPERIORITY||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.74|2.39||||||||2.39|0.74|
71047746|NCT01195272|141604373|SUPERIORITY_OR_OTHER|||||||0.43|||||||ANOVA|||Visit 5 versus Visit 2||||0.43
71047747|NCT01195272|141604373|SUPERIORITY_OR_OTHER|||||||0.44|||||||ANOVA|||Visit 5 versus Visit 3||||0.44
71047748|NCT01195272|141604374|SUPERIORITY_OR_OTHER|||||||0.313|||||||ANOVA|||Visit 3 versus Visit 2||||0.313
71047749|NCT01195272|141604374|SUPERIORITY_OR_OTHER|||||||0.083|||||||ANOVA|||Visit 5 versus Visit 2||||0.083
71047750|NCT01195272|141604374|SUPERIORITY_OR_OTHER|||||||0.092|||||||ANOVA|||Visit 5 versus Visit 3||||0.092
71047751|NCT01195272|141604374|SUPERIORITY_OR_OTHER|||||||0.145|||||||ANOVA|||Visit 8 versus Visit 2||||0.145
71047752|NCT01195272|141604374|SUPERIORITY_OR_OTHER|||||||0.398|||||||ANOVA|||Visit 8 versus Visit 3||||0.398
71047753|NCT01195272|141604374|SUPERIORITY_OR_OTHER|||||||0.138|||||||ANOVA|||Visit 8 versus Visit 5||||0.138
71047754|NCT01195272|141604375|SUPERIORITY_OR_OTHER|||||||0.467|||||||ANOVA|||Visit 3 versus Visit 2||||0.467
71047755|NCT01195272|141604375|SUPERIORITY_OR_OTHER|||||||0.25|||||||ANOVA|||Visit 5 versus Visit 2||||0.250
71047756|NCT01195272|141604375|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANOVA|||Visit 5 versus Visit 3||||0.060
71047757|NCT01195272|141604375|SUPERIORITY_OR_OTHER|||||||0.149|||||||ANOVA|||Visit 8 versus Visit 2||||0.149
71047758|NCT01195272|141604375|SUPERIORITY_OR_OTHER|||||||0.061|||||||ANOVA|||Visit 8 versus Visit 3||||0.061
71047759|NCT01195272|141604375|SUPERIORITY_OR_OTHER|||||||0.047|||||||ANOVA|||Visit 8 versus Visit 5||||0.047
71047760|NCT01195272|141604376|SUPERIORITY_OR_OTHER|||||||0.169|||||||ANOVA|||Visit 3 versus Visit 2||||0.169
71047761|NCT01195272|141604376|SUPERIORITY_OR_OTHER|||||||0.165|||||||ANOVA|||Visit 5 versus Visit 2||||0.165
71047762|NCT01195272|141604376|SUPERIORITY_OR_OTHER|||||||0.471|||||||ANOVA|||Visit 5 versus Visit 3||||0.471
71047763|NCT01195272|141604376|SUPERIORITY_OR_OTHER|||||||0.243|||||||ANOVA|||Visit 8 versus Visit 2||||0.243
71047764|NCT01195272|141604376|SUPERIORITY_OR_OTHER|||||||0.396|||||||ANOVA|||Visit 8 versus Visit 3||||0.396
71047765|NCT01195272|141604376|SUPERIORITY_OR_OTHER|||||||0.375|||||||ANOVA|||Visit 8 versus Visit 5||||0.375
71047766|NCT01195272|141604377|SUPERIORITY_OR_OTHER|||||||0.496|||||||ANOVA|||Visit 3 versus Visit 2||||0.496
71047767|NCT01195272|141604377|SUPERIORITY_OR_OTHER|||||||0.122|||||||ANOVA|||Visit 5 versus Visit 2||||0.122
71047768|NCT01195272|141604377|SUPERIORITY_OR_OTHER|||||||0.07|||||||ANOVA|||Visit 5 versus Visit 3||||0.070
71047769|NCT01195272|141604377|SUPERIORITY_OR_OTHER|||||||0.135|||||||ANOVA|||Visit 8 versus Visit 2||||0.135
71047770|NCT01195272|141604377|SUPERIORITY_OR_OTHER|||||||0.082|||||||ANOVA|||Visit 8 versus Visit 3||||0.082
71047771|NCT01195272|141604377|SUPERIORITY_OR_OTHER|||||||0.461|||||||ANOVA|||Visit 8 versus Visit 5||||0.461
71047772|NCT04319718|141604404|OTHER|||||||0.025|||||||Fisher Exact|||||||.025
71047773|NCT04319718|141604405|OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||.47
71047774|NCT04319718|141604409|OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||||||.67
71047775|NCT04319718|141604410|OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||.51
71047776|NCT04319718|141604411|OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||||||.09
71047777|NCT04319718|141604412|OTHER|||||||0.65|||||||Mixed Models Analysis|||||||.65
71047778|NCT04319718|141604412|OTHER|||||||0.24|||||||Mixed Models Analysis|||||||.24
71047779|NCT04319718|141604412|OTHER|||||||0.27|||||||Mixed Models Analysis|||||||.27
71013218|NCT00234533|141533387|OTHER|An one-way Analysis of Covariance (ANOVA) was used to calculate the between patient variation and within patient variation and then the ICC and its confidence limitations.|ICC|0.9|||||TWO_SIDED|95.0|0.88|0.92|||||An ICC ≥ 0.8 was considered satisfactory and indicative that a single sample would be representative of the overall IGF-I status.|An Intra-class Correlation Coefficient (ICC) for the evening series (defined as 12:00 to 24:00) was determined for the overall ITT population to confirm whether only one measurement would be sufficient to accurately represent the IGF-I measurement over Weeks 21, 22 and 23. The ICC expresses the relative magnitude of the 2 components of the total variability, i.e. the biological variability and random error, in a series of measurements on different patients.||0.92|0.88|
71013219|NCT00234533|141533387|OTHER|An one-way ANOVA was used to calculate the between patient variation and within patient variation and then the ICC and its confidence limitations.|ICC|0.92|||||TWO_SIDED|95.0|0.9|0.93|||||An ICC ≥ 0.8 was considered satisfactory and indicative that a single sample would be representative of the overall IGF-I status.|An ICC for the morning series (defined as 06:00 to 12:00) was determined for the overall ITT population to confirm whether only one measurement would be sufficient to accurately represent the IGF-I measurement over Weeks 21, 22 and 23. The ICC expresses the relative magnitude of the 2 components of the total variability, i.e. the biological variability and random error, in a series of measurements on different patients.||0.93|0.90|
71013220|NCT00234533|141533388|OTHER||Fisher's F statistic (F) value|1.79|||||TWO_SIDED|||||||||Analysis of the weekly timing effect (Week 21 versus Week 22 versus Week 23) on the IGF-I value as measured by capillary blood spot method.|For the effect of the weekly timing on the IGF-I levels; F value = 1.79 and the significance probability value, PR\>F = 0.1678.|||
71013221|NCT00234533|141533388|OTHER||F value|1.06|||||TWO_SIDED|||||||||Analysis of the daily timing effect (morning versus evening) on the IGF-I value as measured by capillary blood spot method.|For the effect of the daily timing on the IGF-I levels; F value = 1.06 and the significance probability value, PR\>F = 0.3035|||
71013222|NCT00234533|141533389|OTHER||F value|83.97|||||TWO_SIDED|||||||||Analysis of the effect of the patient's sex (male versus female) on the IGF-I value as measured by capillary blood spot method.|For the effect of the patient's sex on the IGF-I levels; F value = 83.97 and the significance probability value, PR\>F = \<0.0001.|||
71013223|NCT00234533|141533389|OTHER||F value|68.35|||||TWO_SIDED|||||||||Analysis of the effect of the patient's pubertal status (pubertal versus prepubertal) on the IGF-I value as measured by capillary blood spot method.|For the effect of the patient's pubertal status on the IGF-I levels; F value = 68.35 and the significance probability value, PR\>F = \<0.0001.|||
71013224|NCT00234533|141533390|OTHER||F value|10.73|||||TWO_SIDED|||||||||Analysis of the disease condition (GHD versus TS) on the IGF-I value as measured by capillary blood spot method.|For the effect of the disease condition on the IGF-I levels; F value = 10.73 and the significance probability value, PR\>F = 0.0012.|||
71013225|NCT00234533|141533390|OTHER||F value|2.2|||||TWO_SIDED|||||||||Analysis of the country cluster on the IGF-I value as measured by capillary blood spot method.|For the effect of the country cluster on the IGF-I levels; F value = 2.20 and the significance probability value, PR\>F = 0.0701.|||
71047780|NCT02307266|141604457|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3165|||||||Cochran-Mantel-Haenszel|||||||0.3165
71047781|NCT02307266|141604457|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0206|||||||Cochran-Mantel-Haenszel|||||||0.0206
71104052|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.45|||||TWO_SIDED|95.0|1.61|3.72||||||At risk subjects.||3.72|1.61|
71104053|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.46|||||TWO_SIDED|95.0|1.88|6.34||||||At risk subjects||6.34|1.88|
71013226|NCT00234533|141533391|OTHER||F value|3.65|||||TWO_SIDED|||||||||Analysis of the time of the year on the IGF-I value as measured by capillary blood spot method.|For the effect of the time of the year on the IGF-I levels; F value = 3.65 and the significance probability value, PR\>F = 0.0139.|||
71013227|NCT00234533|141533391|OTHER||F value|7.38|||||TWO_SIDED|||||||||Analysis of the effect of the calculated age at enrolment on the IGF-I value as measured by capillary blood spot method.|For the effect of the calculated age at enrolment on the IGF-I levels; F value = 7.38 and the significance probability value, PR\>F = 0.0073.|||
71047782|NCT02766374|141604478|SUPERIORITY||||||>|0.1|||||||GEE regression|||||||>0.1
71047783|NCT03573505|141604528|SUPERIORITY||Hazard Ratio (HR)|2.01||||0.112|TWO_SIDED|95.0|0.85|4.73|||Log Rank|||A cox proportional hazards model with terms for treatment (BG00011 vs. placebo) and randomization stratification factor is used. A stratified log-rank test is used to compare the 2 treatment groups using randomization stratus as the stratification factor. An HR (Hazard Ratio) \< 1 indicates lower risk of event for the BG00011 group where HR is based on Cox proportional hazard model with treatment (Placebo, BG00011) as the categorical covariate.||4.73|0.85|0.112
71047784|NCT03222583|141604546|NON_INFERIORITY|The percentage of participants in Arm A with SVR12 was non-inferior to the historical SVR12 rate of 96% if the lower confidence bound (LCB) of the 2-sided 95% confidence interval (CI) for the percentage was \> 90%.|Percentage of Participants with SVR12|97.2|||||TWO_SIDED|95.0|95.5|98.9||||||In order to control the Type I error rate, a fixed sequence testing procedure was used for the 3 ranked primary efficacy endpoints. Only if success had been demonstrated for the first primary endpoint was testing to proceed to the second primary endpoint. Similarly, only if success had been demonstrated for the second primary endpoint was testing to proceed to the third primary endpoint.||98.9|95.5|
71104054|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratios (H1N1 strain)|3.52|||||TWO_SIDED|95.0|3.03|4.1||||||No risk subjects.||4.1|3.03|
71104055|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.36|||||TWO_SIDED|95.0|2.15|2.59||||||No risk subjects.||2.59|2.15|
71104056|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.14|||||TWO_SIDED|95.0|2.78|3.56||||||No risk subjects.||3.56|2.78|
71013228|NCT00234533|141533391|OTHER||F value|3.86|||||TWO_SIDED|||||||||Analysis of the effect of the disease condition on the IGF-I value as measured by capillary blood spot method.|For the effect of the disease condition on the IGF-I levels; F value = 3.86 and the significance probability value, PR\>F = 0.0511|||
71013229|NCT00234533|141533392|OTHER||Mean difference|-164.79|STANDARD_ERROR_OF_MEAN|159.28|||TWO_SIDED|95.0|-483.35|-153.77||||||The Bland and Altman method was used to compare the results of each of the three simultaneous random capillary and serum measurements were compared. The difference between the capillary blood spot method and the serum IGF-I measurements is presented||-153.77|-483.35|
71013230|NCT01484691|141533404|SUPERIORITY||Mean Difference (Net)|3.04||||0.32|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir1||||0.32
71013231|NCT01484691|141533404|SUPERIORITY||Mean Difference (Final Values)|1.91||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir107||||0.38
71013232|NCT01484691|141533404|SUPERIORITY||Mean Difference (Net)|0.47||||0.83|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir128||||0.83
71013233|NCT01484691|141533404|SUPERIORITY||Mean Difference (Net)|1.27||||0.42|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir141||||0.42
71013234|NCT01484691|141533404|SUPERIORITY||Mean Difference (Net)|2.55||||0.32|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir148b||||0.32
71013235|NCT01484691|141533404|SUPERIORITY||Mean Difference (Net)|0.68||||0.83|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir181b||||0.83
71013236|NCT01484691|141533404|SUPERIORITY||Mean Difference (Net)|1.94||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir185||||0.38
71013237|NCT01484691|141533404|SUPERIORITY||Mean Difference (Net)|2.77||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir194||||0.38
71013238|NCT01484691|141533404|SUPERIORITY||Mean Difference (Net)|3.38||||0.32|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir19a||||0.32
71013239|NCT01484691|141533404|SUPERIORITY||Mean Difference (Net)|0.0||||0.99|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir200a||||0.99
71013240|NCT01484691|141533404|SUPERIORITY||Mean Difference (Net)|1.92||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir22||||0.38
71013241|NCT01484691|141533404|SUPERIORITY||Mean Difference (Net)|1.57||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir223||||0.38
71013242|NCT01484691|141533404|SUPERIORITY||Mean Difference (Net)|0.52||||0.83|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir23a||||0.83
71013243|NCT01484691|141533404|SUPERIORITY||Mean Difference (Net)|0.81||||0.83|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir26a||||0.83
71047785|NCT03222583|141604547|NON_INFERIORITY|The percentage of GT1-infected participants in Arm A with SVR12 was non-inferior to the historical SVR12 rate of 97% if the LCB of the 2-sided 95% CI for the percentage was \> 91%.|Percentage of Participants with SVR12|99.4|||||TWO_SIDED|95.0|98.3|100.0||||||In order to control the Type I error rate, a fixed sequence testing procedure was used for the 3 ranked primary efficacy endpoints. Only if success had been demonstrated for the first primary endpoint was testing to proceed to the second primary endpoint. Similarly, only if success had been demonstrated for the second primary endpoint was testing to proceed to the third primary endpoint.||100.0|98.3|
71047786|NCT03222583|141604548|NON_INFERIORITY|The percentage of GT2-infected participants in Arm A with SVR12 was non-inferior to the historical SVR12 rate of 95% if the LCB of the 2-sided 95% CI for the percentage was \> 89%.|Percentage of Participants with SVR12|97.8|||||TWO_SIDED|95.0|95.4|100.0||||||In order to control the Type I error rate, a fixed sequence testing procedure was used for the 3 ranked primary efficacy endpoints. Only if success had been demonstrated for the first primary endpoint was testing to proceed to the second primary endpoint. Similarly, only if success had been demonstrated for the second primary endpoint was testing to proceed to the third primary endpoint.||100.0|95.4|
71047787|NCT04280705|141604552|SUPERIORITY||Cox Proportional Hazard|1.29|||<|0.001|TWO_SIDED|95.0|1.12|1.49|||Log Rank|||||1.49|1.12|<0.001
71047788|NCT04280705|141604576|SUPERIORITY|||||||0.058|||||||Barnard's Exact Test|||||||0.058
71047789|NCT04280705|141604577|SUPERIORITY|||||||0.01|||||||Barnard's Exact Test|||||||0.010
71047790|NCT04280705|141604589|SUPERIORITY||Cox Proportional Hazard|1.23||||0.002|TWO_SIDED|95.0|1.08|1.41|||Log Rank|||||1.41|1.08|0.002
71013244|NCT01484691|141533404|SUPERIORITY||Mean Difference (Net)|1.39||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir320b||||0.38
71013245|NCT01484691|141533404|SUPERIORITY||Mean Difference (Net)|-0.92||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir598||||0.38
71013246|NCT01484691|141533404|SUPERIORITY||Mean Difference (Net)|0.55||||0.83|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir720||||0.83
71013247|NCT01484691|141533404|SUPERIORITY||Mean Difference (Net)|-1.12||||0.3|TWO_SIDED||||||t-test, 2 sided|||mir1915||||0.30
71013248|NCT01484691|141533404|SUPERIORITY||Mean Difference (Net)|-1.35||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir1978||||0.38
71013249|NCT01484691|141533405|SUPERIORITY||Mean Difference (Net)|4.53||||0.26|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir1||||0.26
71013250|NCT01484691|141533405|SUPERIORITY||Mean Difference (Net)|4.52||||0.26|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir107||||0.26
71013251|NCT01484691|141533405|SUPERIORITY||Mean Difference (Net)|3.57||||0.26|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir128||||0.26
71013252|NCT01484691|141533405|SUPERIORITY||Mean Difference (Net)|-0.58||||0.87|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir141||||0.87
71013253|NCT01484691|141533405|SUPERIORITY||Mean Difference (Net)|4.57||||0.29|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir148b||||0.29
71013254|NCT01484691|141533405|SUPERIORITY||Mean Difference (Net)|1.56||||0.75|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir181b||||0.75
71013255|NCT01484691|141533405|SUPERIORITY||Mean Difference (Net)|2.9||||0.36|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir185||||0.36
71013256|NCT01484691|141533405|SUPERIORITY||Mean Difference (Net)|-0.36||||0.89|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir194||||0.89
71013257|NCT01484691|141533405|SUPERIORITY||Mean Difference (Net)|2.48||||0.48|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir19a||||0.48
71013258|NCT01484691|141533405|SUPERIORITY||Mean Difference (Net)|0.75||||0.87|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir200a||||0.87
71013259|NCT01484691|141533405|SUPERIORITY||Mean Difference (Net)|2.78||||0.53|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir22||||0.53
71013260|NCT01484691|141533405|SUPERIORITY||Mean Difference (Net)|1.91||||0.57|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir223||||0.57
71047791|NCT04280705|141604590|SUPERIORITY||Cox Proportional Hazard|1.29|||<|0.001|TWO_SIDED|95.0|1.12|1.48|||Log Rank|||||1.48|1.12|<0.001
71047792|NCT04280705|141604591|SUPERIORITY||Cox Proportional Hazard|1.27|||<|0.001|TWO_SIDED|95.0|1.1|1.46|||Log Rank|||||1.46|1.10|<0.001
71047793|NCT04280705|141604592|SUPERIORITY||Cox Proportional Hazard|1.07|||||TWO_SIDED|95.0|0.73|1.58||||||This analysis is for Asian participants||1.58|0.73|
71013261|NCT01484691|141533405|SUPERIORITY||Mean Difference (Net)|4.27||||0.26|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir23a||||0.26
71013262|NCT01484691|141533405|SUPERIORITY||Mean Difference (Net)|1.66||||0.75|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir26a||||0.75
71013263|NCT01484691|141533405|SUPERIORITY||Mean Difference (Net)|-0.91||||0.89|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir320b||||0.89
71013264|NCT01484691|141533405|SUPERIORITY||Mean Difference (Net)|3.32||||0.26|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir598||||0.26
71047794|NCT04280705|141604592|SUPERIORITY||Cox Proportional Hazard|1.25|||||TWO_SIDED|95.0|0.91|1.72||||||This analysis is for Black or African American participants||1.72|0.91|
71047795|NCT04280705|141604592|SUPERIORITY||Cox Proportional Hazard|1.29|||||TWO_SIDED|95.0|1.06|1.57||||||This analysis is for White participants||1.57|1.06|
71047796|NCT04280705|141604592|SUPERIORITY||Cox Proportional Hazard|1.68|||||TWO_SIDED|95.0|1.1|2.58||||||This analysis is for Race of Other participants||2.58|1.10|
71013265|NCT01484691|141533405|SUPERIORITY||Mean Difference (Net)|-0.99||||0.87|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir720||||0.87
71013266|NCT01484691|141533405|SUPERIORITY||Mean Difference (Net)|-0.75||||0.74|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir1915||||0.74
71013267|NCT01484691|141533405|SUPERIORITY||Mean Difference (Net)|3.77||||0.36|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir1978||||0.36
71047797|NCT04280705|141604593|SUPERIORITY||Cox Proportional Hazard|1.31|||||TWO_SIDED|95.0|1.1|1.55||||||This analysis is for Not Hispanic or Latino participants||1.55|1.10|
71013268|NCT01314261|141533417|SUPERIORITY_OR_OTHER|||||||0.336|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV subgenotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||Ten participants in an ABT-267 arm and nine participants in the placebo arm would provide 84% power using Fisher's exact test with two-sided significance level of 0.05 to detect a difference of approximately 70% between the two arms.||||0.336
71013269|NCT01314261|141533417|SUPERIORITY_OR_OTHER|||||||0.171|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||Ten participants in an ABT-267 arm and nine participants in the placebo arm would provide 84% power using Fisher's exact test with two-sided significance level of 0.05 to detect a difference of approximately 70% between the two arms.||||0.171
71013270|NCT01314261|141533417|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||Ten participants in an ABT-267 arm and nine participants in the placebo arm would provide 84% power using Fisher's exact test with two-sided significance level of 0.05 to detect a difference of approximately 70% between the two arms.||||0.030
71013271|NCT01314261|141533418|SUPERIORITY_OR_OTHER|||||||0.102|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or \> median).||||||0.102
71013272|NCT01314261|141533418|SUPERIORITY_OR_OTHER|||||||0.362|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or \> median).||||||0.362
71013273|NCT01314261|141533418|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or \> median).||||||0.079
71013274|NCT01314261|141533422|SUPERIORITY_OR_OTHER|||||||0.083|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or \> median).||||||0.083
71013275|NCT01314261|141533422|SUPERIORITY_OR_OTHER|||||||0.515|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or \> median).||||||0.515
71013276|NCT01314261|141533422|SUPERIORITY_OR_OTHER|||||||0.221|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or \> median).||||||0.221
71013277|NCT01314261|141533423|SUPERIORITY_OR_OTHER|||||||0.155|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.155
71013278|NCT01314261|141533423|SUPERIORITY_OR_OTHER|||||||0.214|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.214
71013279|NCT01314261|141533423|SUPERIORITY_OR_OTHER|||||||0.231|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.231
71013280|NCT01314261|141533424|SUPERIORITY_OR_OTHER|||||||0.127|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.127
71013281|NCT01314261|141533424|SUPERIORITY_OR_OTHER|||||||0.328|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.328
71013282|NCT01314261|141533424|SUPERIORITY_OR_OTHER|||||||0.166|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.166
71013283|NCT01314261|141533425|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Log Rank|||||||0.007
71013284|NCT01314261|141533425|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Log Rank|||||||0.029
71013285|NCT01314261|141533425|SUPERIORITY_OR_OTHER|||||||0.105|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Log Rank|||||||0.105
71013286|NCT01314261|141533428|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.028
71013287|NCT01314261|141533428|SUPERIORITY_OR_OTHER|||||||0.051|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.051
71013288|NCT01314261|141533428|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.021
71013289|NCT01458535|141533449|SUPERIORITY_OR_OTHER|||||||0.157|||||||Cochran-Mantel-Haenszel|||||||0.157
71013290|NCT01458535|141533449|SUPERIORITY_OR_OTHER|||||||0.999|||||||Cochran-Mantel-Haenszel|||||||0.999
71013291|NCT01458535|141533449|SUPERIORITY_OR_OTHER|||||||0.045|||||||Cochran-Mantel-Haenszel|||||||0.045
71013292|NCT01238861|141533456|SUPERIORITY_OR_OTHER||Rate Ratio|1.09||||0.781|TWO_SIDED|80.0|0.74|1.59|||Poisson Regression Method||The p-value was calculated by Poisson regression with over-dispersion adjustment factor. The correction for potential over dispersion was made by Pearson chi-square.|||1.59|0.74|0.781
71013293|NCT01238861|141533456|SUPERIORITY_OR_OTHER||Rate Ratio|0.64||||0.173|TWO_SIDED|80.0|0.42|0.97|||Poisson Regression Method||The p-value was calculated by Poisson regression with over-dispersion adjustment factor. The correction for potential over dispersion was made by Pearson chi-square.|||0.97|0.42|0.173
71013294|NCT01238861|141533456|SUPERIORITY_OR_OTHER||Rate ratio|0.59||||0.096|TWO_SIDED|80.0|0.4|0.89|||Poisson Regression Method||The p-value was calculated by Poisson regression with over-dispersion adjustment factor. The correction for potential over dispersion was made by Pearson chi-square.|||0.89|0.40|0.096
71013295|NCT01238861|141533461|SUPERIORITY_OR_OTHER|||||||0.125|||||||ANCOVA|P-value was calculated by analysis of covariance (ANCOVA) with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.125
71104057|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.7|||||TWO_SIDED|95.0|1.28|5.68||||||At risk subjects.||5.68|1.28|
71104058|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|3.25|||||TWO_SIDED|95.0|2.09|5.06||||||At risk subjects.||5.06|2.09|
71104059|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|2.76|||||TWO_SIDED|95.0|1.44|5.3||||||At risk subjects.||5.3|1.44|
71013296|NCT01238861|141533461|SUPERIORITY_OR_OTHER|||||||0.074|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.074
71013297|NCT01238861|141533461|SUPERIORITY_OR_OTHER|||||||0.057|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.057
71013298|NCT01238861|141533461|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.010
71013299|NCT01238861|141533463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.182||||0.131|TWO_SIDED|80.0|-0.336|-0.028|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||-0.028|-0.336|0.131
71013300|NCT01238861|141533463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.173||||0.126|TWO_SIDED|80.0|-0.317|-0.028|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||-0.028|-0.317|0.126
71013301|NCT01238861|141533463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.097|TWO_SIDED|80.0|-0.247|-0.032|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||-0.032|-0.247|0.097
71013302|NCT01238861|141533464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.174||||0.642|TWO_SIDED|80.0|-0.654|0.306|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use without prophylactic at Week 51-52.||0.306|-0.654|0.642
71013303|NCT01238861|141533464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111||||0.824|TWO_SIDED|80.0|-0.533|0.756|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use without prophylactic at Week 51-52.||0.756|-0.533|0.824
71013304|NCT01238861|141533464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.029||||0.91|TWO_SIDED|80.0|-0.297|0.355|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use without prophylactic at Week 51-52.||0.355|-0.297|0.910
71013305|NCT01238861|141533464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004||||0.992|TWO_SIDED|80.0|-0.602|0.593|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use with prophylactic at Week 51-52.||0.593|-0.602|0.992
71013306|NCT01238861|141533464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.337||||0.624|TWO_SIDED|80.0|-0.548|1.222|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use with prophylactic at Week 51-52.||1.222|-0.548|0.624
71104060|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.81|||||TWO_SIDED|95.0|2.34|3.37||||||No risk subjects.||3.37|2.34|
71104061|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.04|||||TWO_SIDED|95.0|1.83|2.28||||||No risk subjects.||2.28|1.83|
71104062|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.74|||||TWO_SIDED|95.0|3.22|4.34||||||No risk subjects||4.34|3.22|
71013307|NCT01238861|141533464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.645|TWO_SIDED|80.0|-0.267|0.567|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use with prophylactic at Week 51-52.||0.567|-0.267|0.645
71013308|NCT01238861|141533465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157||||0.014|TWO_SIDED|80.0|0.076|0.237|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.237|0.076|0.014
71013309|NCT01238861|141533465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184||||0.004|TWO_SIDED|80.0|0.102|0.266|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.266|0.102|0.004
71013310|NCT01238861|141533465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091||||0.026|TWO_SIDED|80.0|0.039|0.143|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.143|0.039|0.026
71013311|NCT01238861|141533466|SUPERIORITY_OR_OTHER|||||||0.384|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.384
71013312|NCT01238861|141533466|SUPERIORITY_OR_OTHER|||||||0.092|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.092
71013313|NCT01238861|141533466|SUPERIORITY_OR_OTHER|||||||0.134|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.134
71013314|NCT01238861|141533466|SUPERIORITY_OR_OTHER|||||||0.129|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.129
71013315|NCT01238861|141533468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.404||||0.069|TWO_SIDED|80.0|0.121|0.687|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.687|0.121|0.069
71013316|NCT01238861|141533468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.462||||0.049|TWO_SIDED|80.0|0.163|0.761|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.761|0.163|0.049
70941423|NCT01485991|141383551|SUPERIORITY_OR_OTHER||Difference in proportions|-1.1||||0.001|TWO_SIDED|95.0|-7.8|5.5||based on the asymptotic distribution of the generalized Cochran-Mantel-Haenszel statistic controlling for stratification factors, using a non-inferiority margin of 12 percent|Stratified Cochran-Mantel-Haenszel|||||5.5|-7.8|0.001
71013317|NCT01238861|141533468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238||||0.168|TWO_SIDED|80.0|0.017|0.459|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.459|0.017|0.168
71013318|NCT01238861|141533469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.51|TWO_SIDED|80.0|-0.058|0.019|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.019|-0.058|0.510
71013319|NCT01238861|141533469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.041||||0.113|TWO_SIDED|80.0|0.008|0.074|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.074|0.008|0.113
71013320|NCT01238861|141533469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011||||0.599|TWO_SIDED|80.0|-0.016|0.038|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.038|-0.016|0.599
71013321|NCT01238861|141533470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.373||||0.871|TWO_SIDED|80.0|-3.333|2.586|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||2.586|-3.333|0.871
71013322|NCT01238861|141533470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.857||||0.227|TWO_SIDED|80.0|-0.175|5.889|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||5.889|-0.175|0.227
70941424|NCT04864236|141383555|EQUIVALENCE|We compared particle number counts between intervention and control groups using the Wilcoxon test. Analyses were conducted using IBM SPSS V28 and p-values \<0.05 were considered statistically significant.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70941425|NCT04864236|141383556|EQUIVALENCE|Patient characteristics were summarized between groups using mean (SD) and formally compared using the t-test.||||||0.073|||||||t-test, 1 sided|||||||0.073
71013323|NCT01238861|141533470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.139||||0.503|TWO_SIDED|80.0|-1.041|3.319|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||3.319|-1.041|0.503
71013324|NCT01238861|141533471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.907||||0.55|TWO_SIDED|80.0|-4.483|12.297|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||12.297|-4.483|0.550
71013325|NCT01238861|141533471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.659||||0.215|TWO_SIDED|80.0|-0.262|15.579|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||15.579|-0.262|0.215
71013326|NCT01238861|141533471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.54||||0.413|TWO_SIDED|80.0|-2.006|9.086|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||9.086|-2.006|0.413
71013327|NCT01238861|141533472|SUPERIORITY_OR_OTHER|||||||0.896|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.896
71047798|NCT04280705|141604593|SUPERIORITY||Cox Proportional Hazard|1.28|||||TWO_SIDED|95.0|0.94|1.73||||||This analysis is for Hispanic or Latino participants||1.73|0.94|
71013328|NCT01238861|141533472|SUPERIORITY_OR_OTHER|||||||0.944|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.944
71013329|NCT01238861|141533472|SUPERIORITY_OR_OTHER|||||||0.667|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.667
71013330|NCT04602078|141533498|SUPERIORITY|||||||0.444|||||||Log Rank|||Comparisong between subgroups: patients with PD-L1 postive versus patients with PD-L1 negative||||0.444
71013331|NCT04602078|141533499|SUPERIORITY|||||||0.414|||||||Chi-squared|||Comparisong between subgroups: patients with PD-L1 postive versus patients with PD-L1 negative||||0.414
70928753|NCT04800211|141353088|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|63.944||||0.2688|TWO_SIDED|95.0|-49.678|177.565|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||177.565|-49.678|0.2688
70928754|NCT04800211|141353088|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|151.222||||0.0096|TWO_SIDED|95.0|37.114|265.33|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||265.330|37.114|0.0096
70928755|NCT04800211|141353088|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|182.631||||0.0023|TWO_SIDED|95.0|65.754|299.509|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||299.509|65.754|0.0023
70941426|NCT04864236|141383557|EQUIVALENCE|Patient characteristics and study variables were summarized between groups using mean (SD) and formally compared using the t-test.||||||0.67|||||||t-test, 1 sided|||||||0.670
70941427|NCT04864236|141383558|EQUIVALENCE|Patient characteristics were summarized between groups using mean (SD) and formally compared using the t-test.||||||0.167|||||||t-test, 1 sided|||||||0.167
71013332|NCT03413618|141533540|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71013333|NCT03413618|141533541|SUPERIORITY|||||||0.049|||||||Log Rank|||||||0.049
71013334|NCT03413618|141533543|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71013335|NCT03413618|141533544|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71013336|NCT03413618|141533546|SUPERIORITY|||||||0.001|||||||Fisher Exact|||||||0.001
71013337|NCT03413618|141533547|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71013338|NCT01374516|141533594|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|60.8|||||TWO_SIDED|95.0|52.0|68.0||||||The statistical methodology was based on the use of the two-sided 95% confidence interval (CI) of the vaccine efficacy (expressed in %). The CI was calculated using the exact method conditional on the total number of cases in both groups (exact method by Breslow \& Day). The vaccine efficacy of the CYD dengue vaccine was considered significant if the lower bound of its 95% CI was greater than 25%.||68.0|52.0|
71104063|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.34|||||TWO_SIDED|95.0|0.92|6.0||||||At risk subjects.||6|0.92|
71104064|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.93|||||TWO_SIDED|95.0|1.57|5.45||||||At risk subjects.||5.45|1.57|
71013339|NCT01374516|141533595|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|64.7|||||TWO_SIDED|95.0|58.7|69.8||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.||69.8|58.7|
71013340|NCT01374516|141533596|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|64.7|||||TWO_SIDED|95.0|58.7|69.9||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.||69.9|58.7|
71013341|NCT01374516|141533597|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|61.9|||||TWO_SIDED|95.0|54.7|68.0||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.||68.0|54.7|
71013342|NCT00401726|141533636|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.25||||0.218|||||||Chi-squared|||||||0.218
71013343|NCT00401726|141533637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.76||95.0|-0.92|1.25|||ANCOVA|||||1.25|-0.92|0.76
71013344|NCT00401726|141533638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.148||95.0|-0.41|0.06|||ANCOVA|||||0.06|-0.41|0.148
71013345|NCT00401726|141533639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.829||95.0|-1.09|0.87|||ANCOVA|||||0.87|-1.09|0.829
71013346|NCT00401726|141533640|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.57||||0.728|||||||Chi-squared|||||||0.728
71013347|NCT00401726|141533641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.805||95.0|-2.24|1.74|||ANCOVA|||||1.74|-2.24|0.805
71013348|NCT00401726|141533642|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.123||95.0|-2.27|0.27|||ANCOVA|||||0.27|-2.27|0.123
71013349|NCT00401726|141533643|SUPERIORITY_OR_OTHER|||||||0.961|||||||Cochran-Mantel-Haenszel|p-value based on comparison of mean score differences||CGI-I raw scores (range 1-7) analyzed by generalized Cochran-Mantel-Haenszel (CMH) test, stratified by study center using the ridit scoring option.||||0.961
71047799|NCT04280705|141604594|SUPERIORITY||Cox Proportional Hazard|1.3|||||TWO_SIDED|95.0|1.09|1.56||||||This analysis is for Male participants||1.56|1.09|
71013350|NCT02067728|141533645|SUPERIORITY_OR_OTHER|||||||0.0029|TWO_SIDED||||||Chi-squared|||||||0.0029
71047800|NCT04280705|141604594|SUPERIORITY||Cox Proportional Hazard|1.31|||||TWO_SIDED|95.0|1.03|1.66||||||This analysis is for Female participants||1.66|1.03|
71013351|NCT02067728|141533646|SUPERIORITY_OR_OTHER|||||||0.3875|TWO_SIDED||||||t-test, 2 sided|||||||0.3875
71013352|NCT02067728|141533647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26|STANDARD_DEVIATION|0.42|<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71013353|NCT02067728|141533648|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
71047801|NCT05855616|141604616|OTHER||Odds Ratio (OR)|0.533||||1|TWO_SIDED|95.0|0.048|5.892|||t-test, 1 sided|||||5.892|0.048|1.00
71047802|NCT05855616|141604617|OTHER||Odds Ratio (OR)|0.176||||0.013|TWO_SIDED|95.0|0.039|0.79|||t-test, 1 sided|||||0.790|0.039|0.013
71047803|NCT05855616|141604619|OTHER|||||||0.137|||||||Chi-squared, Corrected|||||||0.137
70941428|NCT04864236|141383559|EQUIVALENCE|Patient characteristics were summarized between groups using mean (SD) and formally compared using the t-test.||||||0.198|||||||t-test, 1 sided|||||||0.198
70941429|NCT04864236|141383560|EQUIVALENCE|Patient characteristics were summarized between groups using mean (SD) and formally compared using the t-test.||||||0.442|||||||t-test, 1 sided|||||||0.442
71047804|NCT05855616|141604620|OTHER|||||||0.764|||||||Chi-squared, Corrected|||||||0.764
71047805|NCT05855616|141604621|OTHER|||||||0.055|||||||Chi-squared, Corrected|||||||0.055
71047806|NCT01196078|141604668|SUPERIORITY_OR_OTHER||Difference in Percentages|13.88||||0.0388|TWO_SIDED|95.0|-0.22|26.19||Between-treatment difference computed using logistic regression with treatment and multiple factors (gender, Eastern Cooperative Oncology Group \[ECOG\] status, histology status, and smoking status) as explanatory variables.|Regression, Logistic||95% confidence interval (CI) for the difference in tumor response rate determined using Hauck-Anderson approach.|||26.19|-0.22|0.0388
71047807|NCT01196078|141604669|SUPERIORITY_OR_OTHER||Difference in Percentages|14.79||||0.1061|TWO_SIDED|95.0|-3.54|31.33||Between-treatment difference computed using logistic regression with treatment and multiple factors (gender, ECOG status, histology status, and smoking status) as explanatory variables.|Regression, Logistic||95% CI for the difference in the disease control rate determined using Hauck-Anderson approach.|||31.33|-3.54|0.1061
71013354|NCT02067728|141533649|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||||||1.000
71013355|NCT02067728|141533650|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.3|||<|0.0001|TWO_SIDED|95.0|2.2|4.9|||Chi-squared|||||4.9|2.2|<0.0001
71013356|NCT02067728|141533651|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.9|||<|0.0001|TWO_SIDED|95.0|2.0|4.5|||Chi-squared|||||4.5|2.0|<0.0001
71013357|NCT02067728|141533654|SUPERIORITY_OR_OTHER|||||||0.4835|TWO_SIDED||||||t-test, 2 sided|||||||0.4835
71013358|NCT02067728|141533655|SUPERIORITY_OR_OTHER|||||||0.588|TWO_SIDED||||||t-test, 2 sided|||||||0.5880
71013359|NCT00830310|141533706|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||<0.001
71013360|NCT00830310|141533707|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||0.002
71013361|NCT00830310|141533708|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||0.001
71013362|NCT00830310|141533709|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||0.001
71013363|NCT00830310|141533710|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||0.001
71013364|NCT00830310|141533711|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||0.011
71013365|NCT00830310|141533712|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||0.038
71013366|NCT00830310|141533713|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||0.002
71013367|NCT00830310|141533714|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||<0.001
71013368|NCT01050998|141533715|SUPERIORITY_OR_OTHER||Percent difference|4.9||||0.578|TWO_SIDED|95.0|-11.5|22.0|||Fisher Exact||95 percent (%) unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||22.0|-11.5|0.578
71013369|NCT01050998|141533715|SUPERIORITY_OR_OTHER||Percent difference|30.7|||<|0.001|TWO_SIDED|95.0|13.4|46.3|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||46.3|13.4|<0.001
71013370|NCT01050998|141533715|SUPERIORITY_OR_OTHER||Percent difference|15.3||||0.099|TWO_SIDED|95.0|-1.6|32.2|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||32.2|-1.6|0.099
70928756|NCT04800211|141353088|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-175.901||||0.1612|TWO_SIDED|95.0|-390.865|39.063|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||39.063|-390.865|0.1612
70928757|NCT04800211|141353088|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-227.95||||0.0396|TWO_SIDED|95.0|-448.725|-7.175|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-7.175|-448.725|0.0396
70941430|NCT04474691|141383563|SUPERIORITY||Mean Difference (Final Values)|21.1||||0.67|TWO_SIDED||||||t-test, 1 sided|df = 7|Traditional treatment condition - visual-acoustic biofeedback treatment condition. Because more accurate productions have lower acoustic values, a positive difference would indicate an advantage for biofeedback.|||||.67
71013371|NCT01050998|141533715|SUPERIORITY_OR_OTHER||Percent difference|35.5|||<|0.001|TWO_SIDED|95.0|17.8|50.6|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||50.6|17.8|<0.001
70941431|NCT01209936|141383568|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||||||0.87
71013372|NCT01050998|141533716|SUPERIORITY_OR_OTHER||Percent difference|6.4||||0.543|TWO_SIDED|95.0|-11.9|25.4|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||25.4|-11.9|0.543
71013373|NCT01050998|141533716|SUPERIORITY_OR_OTHER||Percent difference|26.3||||0.011|TWO_SIDED|95.0|7.2|43.6|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||43.6|7.2|0.011
71013374|NCT01050998|141533716|SUPERIORITY_OR_OTHER||Percent difference|16.6||||0.108|TWO_SIDED|95.0|-2.5|35.5|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||35.5|-2.5|0.108
71013375|NCT01050998|141533716|SUPERIORITY_OR_OTHER||Percent difference|32.0||||0.001|TWO_SIDED|95.0|12.5|49.0|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||49.0|12.5|0.001
71013376|NCT01050998|141533716|SUPERIORITY_OR_OTHER||Percent difference|-1.3||||1|TWO_SIDED|95.0|-33.7|35.7|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|Japanese region: p-value was calculated using a two-tailed Fisher's exact test.||35.7|-33.7|1.000
71013377|NCT01050998|141533716|SUPERIORITY_OR_OTHER||Percent difference|51.5||||0.028|TWO_SIDED|95.0|8.2|77.0|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|Japanese region: p-value was calculated using a two-tailed Fisher's exact test.||77.0|8.2|0.028
71013378|NCT01050998|141533716|SUPERIORITY_OR_OTHER||Percent difference|9.8||||0.661|TWO_SIDED|95.0|-24.3|46.9|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|Japanese region: p-value was calculated using a two-tailed Fisher's exact test.||46.9|-24.3|0.661
71013379|NCT01050998|141533717|SUPERIORITY_OR_OTHER||Percent difference|13.0||||0.152|TWO_SIDED|95.0|-4.2|30.3|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||30.3|-4.2|0.152
70941432|NCT01209936|141383569|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
70941433|NCT01209936|141383570|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
71013380|NCT01050998|141533717|SUPERIORITY_OR_OTHER||Percent difference|24.3||||0.008|TWO_SIDED|95.0|7.0|40.3|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||40.3|7.0|0.008
71013381|NCT01050998|141533717|SUPERIORITY_OR_OTHER||Percent difference|21.4||||0.02|TWO_SIDED|95.0|3.9|37.8|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||37.8|3.9|0.020
71013382|NCT01050998|141533717|SUPERIORITY_OR_OTHER||Percent difference|29.0||||0.002|TWO_SIDED|95.0|11.3|45.0|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||45.0|11.3|0.002
71013383|NCT01050998|141533718|SUPERIORITY_OR_OTHER||Percent difference|9.9||||0.328|TWO_SIDED|95.0|-9.3|29.4|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||29.4|-9.3|0.328
71047808|NCT01196078|141604670|SUPERIORITY_OR_OTHER|||||||0.9505|||||||Log Rank|||||||0.9505
71047809|NCT01196078|141604672|SUPERIORITY_OR_OTHER|||||||0.2314|||||||Log Rank|Data were stratified by gender, ECOG status, histology status, and smoking status.||||||0.2314
71047810|NCT01196078|141604674|SUPERIORITY_OR_OTHER|||||||0.9894|||||||Log Rank|Data were stratified by gender, ECOG status, histology status, and smoking status.||||||0.9894
71047811|NCT01196078|141604676|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA|||PWB, Baseline versus Endpoint||||0.0060
71047812|NCT01196078|141604676|SUPERIORITY_OR_OTHER|||||||0.6871|||||||ANOVA|||SWB, Baseline versus Endpoint||||0.6871
71047813|NCT01196078|141604676|SUPERIORITY_OR_OTHER|||||||0.5104|||||||ANOVA|||EWB Baseline versus Endpoint||||0.5104
71047814|NCT01196078|141604676|SUPERIORITY_OR_OTHER|||||||0.9927|||||||ANOVA|||FWB, Baseline versus Endpoint||||0.9927
71047815|NCT01196078|141604676|SUPERIORITY_OR_OTHER|||||||0.3581|||||||ANOVA|||LCS, Baseline versus Endpoint||||0.3581
71047816|NCT03537274|141604709|SUPERIORITY|||||||0.078|||||||Chi-squared|||||||0.078
71047817|NCT03537274|141604709|SUPERIORITY|||||||0.005|||||||Chi-squared|||||||0.005
71047818|NCT03537274|141604709|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
71047819|NCT03537274|141604710|SUPERIORITY|||||||0.128|||||||Chi-squared|||||||0.128
71047820|NCT03537274|141604710|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71047821|NCT03537274|141604710|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71047822|NCT04688931|141604717|OTHER|The analysis is descriptive in nature.|Cox Proportional Hazard|0.45|||||TWO_SIDED|95.0|0.29|0.68|||||The hazard ratio represents the relative risk of having an event in the treatment arm (numerator) versus the control arm (denominator).|||0.68|0.29|
71047823|NCT04688931|141604718|OTHER|The analysis is descriptive in nature.|Cox Proportional Hazard|0.46|||||TWO_SIDED|95.0|0.3|0.7|||||The hazard ratio represents the relative risk of having an event in the treatment arm (numerator) versus the control arm (denominator).|||0.70|0.30|
71047824|NCT04688931|141604720|OTHER|The analysis is descriptive in nature.|Cox Proportional Hazard|0.46|||||TWO_SIDED|95.0|0.24|0.86|||||The hazard ratio represents the relative risk of having an event in the treatment arm (numerator) versus the control arm (denominator).|||0.86|0.24|
71047825|NCT00450619|141604728|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5019||||0.041|TWO_SIDED|95.0|||||Log Rank|||||||0.041
71047826|NCT00450619|141604728|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5019||||0.046|TWO_SIDED|95.0|||||Hazard Ratio|||||||0.046
71047827|NCT00450619|141604732|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.3|TWO_SIDED|95.0|0.37|1.35|||Kaplan Meier|||||1.35|0.37|0.30
71047828|NCT02836496|141604803|SUPERIORITY|||||||0.002||||||Cochran-Mantel-Haenszel test stratified by Baseline oral corticosteroid (OCS) (0-\<=20 mg per day and \>20mg perday prednisone or equivalent) and region|Cochran-Mantel-Haenszel|||||||0.002
71047829|NCT02836496|141604803|SUPERIORITY||Odds Ratio (OR)|0.28||||0.003|TWO_SIDED|95.0|0.12|0.64|||Regression, Logistic|Logistic regression analysis adjusted for Baseline OCS dose and region.|Treatment comparison between placebo and mepolizumab 300 mg using odds ratio and 95% confidence interval (CI) has been presented. Odds ratio \<1 indicated lower odds of HES flare with Mepolizumab compared with placebo.|||0.64|0.12|0.003
71047830|NCT02836496|141604804|SUPERIORITY|||||||0.02|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline OCS (0-\<=20 mg per day and \>20mg perday prednisone or equivalent) and region||||||0.020
71047831|NCT02836496|141604804|SUPERIORITY||Odds Ratio (OR)|0.33||||0.022|TWO_SIDED|95.0|0.13|0.85|||Regression, Logistic|Logistic regression analysis adjusted for Baseline OCS dose and region|Treatment comparison between placebo and mepolizumab 300 mg using odds ratio and 95% CI has been presented. Odds ratio \<1 indicated lower odds of HES flare with Mepolizumab compared with placebo.|||0.85|0.13|0.022
71047832|NCT02836496|141604805|SUPERIORITY||Hazard Ratio (HR)|0.34||||0.002|TWO_SIDED|95.0|0.18|0.67||Cox proportional hazards regression analysis adjusted for Baseline OCS dose and region.|Regression, Cox||Treatment comparison between placebo and mepolizumab 300 mg using hazards ratio and its corresponding 95% CI has been presented. Hazard ratio \<1 indicated a lower risk of HES flare with Mepolizumab compared with Placebo.|||0.67|0.18|0.002
71047833|NCT02836496|141604806|SUPERIORITY||Rate Ratio|0.34||||0.002|TWO_SIDED|95.0|0.19|0.63|||Wilcoxon Rank Sum Test|Wilcoxon test stratified by Baseline OCS (0-\<=20 mg/day, \>20 mg/day prednisone or equivalent) and region.|Treatment comparison between placebo and mepolizumab 300 mg using rate ratio and 95% CI has been presented. Rate ratio \<1 indicates a lower flare rate with Mepolizumab compared with Placebo.|||0.63|0.19|0.002
71013384|NCT01050998|141533718|SUPERIORITY_OR_OTHER||Percent difference|17.2||||0.084|TWO_SIDED|95.0|-2.0|35.6|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||35.6|-2.0|0.084
71013385|NCT01050998|141533718|SUPERIORITY_OR_OTHER||Percent difference|20.2||||0.049|TWO_SIDED|95.0|0.7|38.2|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||38.2|0.7|0.049
71013386|NCT01050998|141533718|SUPERIORITY_OR_OTHER||Percent difference|22.8||||0.03|TWO_SIDED|95.0|3.2|40.7|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||40.7|3.2|0.030
71047834|NCT02836496|141604807|SUPERIORITY|||||||0.036|||||||Wilcoxon Rank Sum Test|P-value was calculated using Wilcoxon Rank Sum Test||||||0.036
71047835|NCT00354341|141604808|SUPERIORITY_OR_OTHER|||||||0.8811|TWO_SIDED|||||P-value was calculated by ANCOVA with last observation carry forward (LOCF) method.|ANCOVA with LOCF|||||||0.8811
71047836|NCT00354341|141604809|SUPERIORITY_OR_OTHER|||||||0.8864|TWO_SIDED||||||ANCOVA with LOCF|||||||0.8864
71047837|NCT00354341|141604810|SUPERIORITY_OR_OTHER|||||||0.5681|TWO_SIDED||||||ANCOVA with LOCF|||||||0.5681
71047838|NCT00354341|141604811|SUPERIORITY_OR_OTHER|||||||0.1578|TWO_SIDED||||||ANCOVA with LOCF|||||||0.1578
71047839|NCT00354341|141604812|SUPERIORITY_OR_OTHER|||||||0.2913|TWO_SIDED||||||ANCOVA with LOCF|||||||0.2913
71047840|NCT00354341|141604813|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared, Corrected|||||||<0.001
71104065|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|5.55|||||TWO_SIDED|95.0|2.52|12.0||||||At risk subjects||12|2.52|
71047841|NCT00251719|141604815|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 95% CI was greater than -10%, noninferiority was concluded. Superiority of primary efficacy endpoint was assessed by comparing the crude healing rate of dexlansoprazole MR 60 mg dose to that of lansoprazole 30 mg using a Cochran Mantel Haenszel (CMH) test with baseline LA EE Grade as strata.|Difference in percentage|2.34||||0.234||95.0|-1.45|6.14||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Cochran-Mantel-Haenszel|||||6.14|-1.45|0.234
71047842|NCT00251719|141604815|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 95% CI was greater than -10%, noninferiority was concluded. Superiority of primary efficacy endpoint was assessed by comparing the crude healing rate of dexlansoprazole MR 90 mg dose to that of lansoprazole 30 mg using a Cochran Mantel Haenszel (CMH) test with baseline LA EE Grade as strata.|Difference in percentage|4.85||||0.019||95.0|1.2|8.5||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Cochran-Mantel-Haenszel|||||8.50|1.20|0.019
71047843|NCT00251719|141604815|SUPERIORITY_OR_OTHER|||||||0.22||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.220
71047844|NCT00251719|141604816|SUPERIORITY_OR_OTHER|||||||0.768||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.768
70928758|NCT04800211|141353088|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-352.366||||0.0002|TWO_SIDED|95.0|-573.315|-131.418|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-131.418|-573.315|0.0002
70928759|NCT04800211|141353088|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-116.449||||0.5616|TWO_SIDED|95.0|-327.445|94.547|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||94.547|-327.445|0.5616
70928760|NCT04800211|141353088|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-162.635||||0.2176|TWO_SIDED|95.0|-375.57|50.299|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||50.299|-375.570|0.2176
70941434|NCT01261793|141383579|SUPERIORITY||Odds Ratio (OR)|1.024|||=|0.899|TWO_SIDED|95.0|0.71|1.477||p-values for the comparison of treatment groups have been calculated using logistic regression with factors for treatment, pooled region, and baseline disease status.|Regression, Logistic||Odds ratio: Epratuzumab/Placebo calculated using logistic regression with factors for treatment, pooled region, and baseline disease status.|||1.477|0.710|=0.899
71047845|NCT00251719|141604816|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.064
71047846|NCT00251719|141604816|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.034
71047847|NCT00251719|141604817|SUPERIORITY_OR_OTHER|||||||0.727||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.727
70941435|NCT01261793|141383579|SUPERIORITY||Odds Ratio (OR)|1.07|||=|0.716|TWO_SIDED|95.0|0.743|1.539||p-values for the comparison of treatment groups have been calculated using logistic regression with factors for treatment, pooled region, and baseline disease status.|Regression, Logistic||Odds ratio: Epratuzumab/Placebo calculated using logistic regression with factors for treatment, pooled region, and baseline disease status.|||1.539|0.743|=0.716
71013387|NCT01050998|141533718|SUPERIORITY_OR_OTHER||Percent difference|26.8||||0.188|TWO_SIDED|95.0|-9.3|60.7|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|Japanese region: p-value was calculated using a two-tailed Fisher's exact test.||60.7|-9.3|0.188
71013388|NCT01050998|141533718|SUPERIORITY_OR_OTHER||Percent difference|57.4||||0.01|TWO_SIDED|95.0|15.2|81.8|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|Japanese region: p-value was calculated using a two-tailed Fisher's exact test.||81.8|15.2|0.010
71013389|NCT01050998|141533739|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.205||0.137|TWO_SIDED|95.0|-0.71|0.1|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||0.10|-0.71|0.137
71013390|NCT01050998|141533739|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.202||0.001|TWO_SIDED|95.0|-1.07|-0.27|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||-0.27|-1.07|0.001
71013391|NCT01050998|141533739|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.201||0.08|TWO_SIDED|95.0|-0.75|0.04|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||0.04|-0.75|0.080
71047848|NCT00251719|141604817|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.064
71047849|NCT00251719|141604817|SUPERIORITY_OR_OTHER|||||||0.174||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Log Rank|||||||0.174
71047850|NCT00251719|141604818|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was supported if the lower bound of the 95% CI for the difference with lansoprazole 30 mg of the estimated 8-week healing rate was greater than -10%. Superiority was assessed based on log-rank tests comparing treatments for the endpoints.|Difference in percentage|1.65||||0.167||95.0|-1.65|4.96||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Log Rank|||||4.96|-1.65|0.167
71047851|NCT00251719|141604818|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was supported if the lower bound of the 95% CI for the difference with lansoprazole 30 mg of the estimated 8-week healing rate was greater than -10%. Superiority was assessed based on log-rank tests comparing treatments for the endpoints.|Difference in percentage|3.39||||0.03||95.0|0.27|6.5||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Log Rank|||||6.50|0.27|0.030
71104066|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|3.66|||||TWO_SIDED|95.0|3.05|4.39||||||No risk subjects.||4.39|3.05|
71013392|NCT01050998|141533739|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.74|STANDARD_ERROR_OF_MEAN|0.204|<|0.001|TWO_SIDED|95.0|-1.14|-0.33|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||-0.33|-1.14|<0.001
71013393|NCT01050998|141533739|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.212||0.107|TWO_SIDED|95.0|-0.76|0.08|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||0.08|-0.76|0.107
71013394|NCT01050998|141533739|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|-1.17|-0.35|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.35|-1.17|<0.001
71047852|NCT00251719|141604818|SUPERIORITY_OR_OTHER|||||||0.413||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Log Rank|||||||0.413
71047853|NCT00251719|141604819|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.100
71047854|NCT00251719|141604819|SUPERIORITY_OR_OTHER|||||||0.125||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.125
71047855|NCT00251719|141604819|SUPERIORITY_OR_OTHER|||||||0.993||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.993
71104067|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.68|||||TWO_SIDED|95.0|2.4|2.99||||||No risk subjects||2.99|2.4|
70941436|NCT00832650|141383590|SUPERIORITY_OR_OTHER||LS Mean difference|0.051|||||TWO_SIDED|95.0|-0.334|0.436|||ANCOVA||Least squares mean was calculated based on the ANCOVA model with treatment group as a fixed effect and baseline values, age and Body Mass Index (BMI) as covariates.|Null H10: μF8mg=μS10mg where μF8mg and μS10mg are means of GC24 for fesoterodine 8mg and solifenacin 10mg, respectively.||0.436|-0.334|
71013395|NCT01050998|141533739|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.209||0.046|TWO_SIDED|95.0|-0.83|-0.01|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.01|-0.83|0.046
71013396|NCT01050998|141533739|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.212|<|0.001|TWO_SIDED|95.0|-1.22|-0.38|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.38|-1.22|<0.001
71013397|NCT01050998|141533740|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.23||0.086|TWO_SIDED|95.0|-0.85|0.06|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||0.06|-0.85|0.086
71013398|NCT01050998|141533740|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.225||0.016|TWO_SIDED|95.0|-0.99|-0.1|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||-0.10|-0.99|0.016
71013399|NCT01050998|141533740|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.225||0.059|TWO_SIDED|95.0|-0.87|0.02|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||0.02|-0.87|0.059
71013400|NCT01050998|141533740|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.227||0.002|TWO_SIDED|95.0|-1.14|-0.25|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||-0.25|-1.14|0.002
71013401|NCT01050998|141533740|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.241||0.107|TWO_SIDED|95.0|-0.87|0.09|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||0.09|-0.87|0.107
71013402|NCT01050998|141533740|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.236||0.007|TWO_SIDED|95.0|-1.11|-0.18|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.18|-1.11|0.007
71013403|NCT01050998|141533740|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.236||0.084|TWO_SIDED|95.0|-0.88|0.06|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||0.06|-0.88|0.084
71013404|NCT01050998|141533740|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.238||0.002|TWO_SIDED|95.0|-1.2|-0.26|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.26|-1.20|0.002
71013405|NCT01050998|141533740|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.447||0.785|TWO_SIDED|95.0|-0.78|1.02|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||1.02|-0.78|0.785
71013406|NCT01050998|141533740|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.19|STANDARD_ERROR_OF_MEAN|0.465||0.014|TWO_SIDED|95.0|-2.13|-0.26|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||-0.26|-2.13|0.014
71013407|NCT01050998|141533740|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.448||0.931|TWO_SIDED|95.0|-0.94|0.86|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||0.86|-0.94|0.931
71013408|NCT01050998|141533740|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.86|STANDARD_ERROR_OF_MEAN|0.465||0.07|TWO_SIDED|95.0|-1.8|0.07|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||0.07|-1.80|0.070
70941437|NCT00257556|141383607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045||||||95.0|-0.17|0.26|||||A two-sided 95% continuity-corrected confidence interval for the difference in percentages, based on the normal approximation|||0.260|-0.170|
70928761|NCT04800211|141353088|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-236.196||||0.0242|TWO_SIDED|95.0|-451.334|-21.059|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-21.059|-451.334|0.0242
70928762|NCT04800211|141353088|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-294.281|||<|0.0001|TWO_SIDED|95.0|-434.513|-154.05|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-154.050|-434.513|<.0001
71013409|NCT01050998|141533740|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.449||0.854|TWO_SIDED|95.0|-0.99|0.82|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||0.82|-0.99|0.854
71013410|NCT01050998|141533740|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.25|STANDARD_ERROR_OF_MEAN|0.468||0.011|TWO_SIDED|95.0|-2.19|-0.31|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.31|-2.19|0.011
71013411|NCT01050998|141533740|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.448||0.271|TWO_SIDED|95.0|-1.4|0.4|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||0.40|-1.40|0.271
71047856|NCT00251719|141604820|SUPERIORITY_OR_OTHER|||||||0.117||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.117
71047857|NCT00251719|141604820|SUPERIORITY_OR_OTHER|||||||0.124||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.124
70941438|NCT04839289|141383619|OTHER||||||>|0.05||||||When p-value is adjusted for multiple comparisons, the level of statistical significance must be \</= to .01666667 (.05/3)|t-test, 2 sided|||"Null hypothesis: Subjective ratings of sound quality would not be different between any of the three study hearing aids when measured with a validated sound quality questionnaire.~Analysis was done after all three home trials completed so all three sets of study devices could be compared."||||>0.05
70941439|NCT04839289|141383619|OTHER||||||<|0.0167||||||When p-value is adjusted for multiple comparisons, the level of statistical significance must be \</= to .01666667 (.05/3)|t-test, 2 sided|||"Null hypothesis: Subjective ratings of sound quality would not be different between any of the three study hearing aids when measured with a validated sound quality questionnaire.~Analysis was done after all three home trials completed so all three sets of study devices could be compared."||||<.0167
71013412|NCT01050998|141533740|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.03|STANDARD_ERROR_OF_MEAN|0.465||0.031|TWO_SIDED|95.0|-1.97|-0.1|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.10|-1.97|0.031
71013413|NCT01050998|141533741|SUPERIORITY_OR_OTHER||Percent difference|7.0||||0.238|TWO_SIDED|95.0|-3.3|20.5|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (CRP): p-value was calculated using a two-tailed Fisher's exact test.||20.5|-3.3|0.238
71047858|NCT00251719|141604820|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Log Rank|||||||0.949
71047859|NCT03822832|141604821|OTHER||Mean Difference (Final Values)|-25.6|STANDARD_ERROR_OF_MEAN|17.4||0.1492|TWO_SIDED|90.0|-54.9|3.7|||Mixed Models Analysis|See endpoint description for model description.|Difference calculated as Spesolimab - Placebo.|||3.7|-54.9|0.1492
71013414|NCT01050998|141533741|SUPERIORITY_OR_OTHER||Percent difference|14.8||||0.017|TWO_SIDED|95.0|2.8|29.7|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (CRP): p-value was calculated using a two-tailed Fisher's exact test.||29.7|2.8|0.017
71013415|NCT01050998|141533741|SUPERIORITY_OR_OTHER||Percent difference|11.1||||0.09|TWO_SIDED|95.0|0.0|25.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (CRP): p-value was calculated using a two-tailed Fisher's exact test.||25.4|0.0|0.090
71013416|NCT01050998|141533741|SUPERIORITY_OR_OTHER||Percent difference|15.8||||0.015|TWO_SIDED|95.0|2.9|31.0|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (CRP): p-value was calculated using a two-tailed Fisher's exact test.||31.0|2.9|0.015
71013417|NCT01050998|141533741|SUPERIORITY_OR_OTHER||Percent difference|3.0||||0.412|TWO_SIDED|95.0|-4.2|14.0|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (ESR): p-value was calculated using a two-tailed Fisher's exact test.||14.0|-4.2|0.412
71013418|NCT01050998|141533741|SUPERIORITY_OR_OTHER||Percent difference|4.9||||0.237|TWO_SIDED|95.0|-2.9|16.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (ESR): p-value was calculated using a two-tailed Fisher's exact test.||16.4|-2.9|0.237
71013419|NCT01050998|141533741|SUPERIORITY_OR_OTHER||Percent difference|5.1||||0.231|TWO_SIDED|95.0|-2.8|16.8|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (ESR): p-value was calculated using a two-tailed Fisher's exact test.||16.8|-2.8|0.231
71013420|NCT01050998|141533741|SUPERIORITY_OR_OTHER||Percent difference|3.1||||0.406|TWO_SIDED|95.0|-4.1|14.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (ESR): p-value was calculated using a two-tailed Fisher's exact test.||14.4|-4.1|0.406
71013421|NCT01050998|141533742|SUPERIORITY_OR_OTHER||Percent difference|8.7||||0.182|TWO_SIDED|95.0|-2.7|24.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||24.4|-2.7|0.182
71013422|NCT01050998|141533742|SUPERIORITY_OR_OTHER||Percent difference|10.4||||0.11|TWO_SIDED|95.0|-1.2|25.5|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||25.5|-1.2|0.110
71013423|NCT01050998|141533742|SUPERIORITY_OR_OTHER||Percent difference|11.3||||0.104|TWO_SIDED|95.0|-0.6|26.9|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||26.9|-0.6|0.104
71013424|NCT01050998|141533742|SUPERIORITY_OR_OTHER||Percent difference|16.4||||0.016|TWO_SIDED|95.0|3.5|32.7|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||32.7|3.5|0.016
71013425|NCT01050998|141533742|SUPERIORITY_OR_OTHER||Percent difference|6.4||||0.115|TWO_SIDED|95.0|-1.0|19.3|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 \[ESR\]): p-value was calculated using a two-tailed Fisher's exact test.||19.3|-1.0|0.115
71013426|NCT01050998|141533742|SUPERIORITY_OR_OTHER||Percent difference|8.4||||0.052|TWO_SIDED|95.0|0.6|21.6|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 \[ESR\]): p-value was calculated using a two-tailed Fisher's exact test.||21.6|0.6|0.052
71013427|NCT01050998|141533742|SUPERIORITY_OR_OTHER||Percent difference|-0.7||||1|TWO_SIDED|95.0|-27.0|34.8|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||34.8|-27.0|1.000
71013428|NCT01050998|141533742|SUPERIORITY_OR_OTHER||Percent difference|38.2||||0.059|TWO_SIDED|95.0|1.6|71.2|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||71.2|1.6|0.059
71013429|NCT01050998|141533742|SUPERIORITY_OR_OTHER||Percent difference|10.5||||0.591|TWO_SIDED|95.0|-18.2|46.2|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||46.2|-18.2|0.591
71013430|NCT01050998|141533742|SUPERIORITY_OR_OTHER||Percent difference|13.2||||0.57|TWO_SIDED|95.0|-16.6|51.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||51.4|-16.6|0.570
71013431|NCT01050998|141533742|SUPERIORITY_OR_OTHER||Percent difference|-11.8||||0.529|TWO_SIDED|95.0|-35.0|22.7|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[ESR\]): p-value was calculated using a two-tailed Fisher's exact test.||22.7|-35.0|0.529
71013432|NCT01050998|141533742|SUPERIORITY_OR_OTHER||Percent difference|-11.8||||1|TWO_SIDED|95.0|-37.5|22.6|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[ESR\]): p-value was calculated using a two-tailed Fisher's exact test.||22.6|-37.5|1.000
71013433|NCT01050998|141533742|SUPERIORITY_OR_OTHER||Percent difference|-0.7||||1|TWO_SIDED|95.0|-27.0|34.8|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[ESR\]): p-value was calculated using a two-tailed Fisher's exact test.||34.8|-27.0|1.000
71013434|NCT01050998|141533743|SUPERIORITY_OR_OTHER||Percent difference|||||0.604|||||||Log Rank|||Analysis reported for DAS28 (CRP) response.||||0.604
71013435|NCT01050998|141533743|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||Analysis reported for DAS28 (CRP) response.||||<0.001
71013436|NCT01050998|141533743|SUPERIORITY_OR_OTHER|||||||0.145|||||||Log Rank|||Analysis reported for DAS28 (CRP) response.||||0.145
71013437|NCT01050998|141533743|SUPERIORITY_OR_OTHER|||||||0.282|||||||Log Rank|||Analysis reported for DAS28 (ESR) response.||||0.282
71013438|NCT01050998|141533743|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||Analysis reported for DAS28 (ESR) response.||||<0.001
70928763|NCT04800211|141353088|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-116.17||||0.1524|TWO_SIDED|95.0|-275.521|43.18|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||43.180|-275.521|0.1524
70928764|NCT04800211|141353089|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-32.792|||<|0.0001|TWO_SIDED|95.0|-39.375|-26.208|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-26.208|-39.375|<.0001
70928765|NCT04800211|141353089|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-25.921|||<|0.0001|TWO_SIDED|95.0|-33.398|-18.443|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-18.443|-33.398|<.0001
70928766|NCT04800211|141353089|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-25.484|||<|0.0001|TWO_SIDED|95.0|-31.99|-18.979|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-18.979|-31.990|<.0001
70928767|NCT04800211|141353089|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-26.899|||<|0.0001|TWO_SIDED|95.0|-34.135|-19.663|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-19.663|-34.135|<.0001
70941440|NCT04839289|141383622|OTHER||||||<|0.01666667||||||When p-value is adjusted for multiple comparisons, the value must be \</= to .01666667 (.05/3).|t-test, 2 sided|||"Null hypothesis: Satisfaction with hearing aid performance and features would not be different between any of the three study hearing aids when measured with subjective hearing aid satisfaction questionnaire.~Analysis was done after all three home trials completed so all three sets of study devices could be compared."||||<.01666667
71013439|NCT01050998|141533743|SUPERIORITY_OR_OTHER|||||||0.047|||||||Log Rank|||Analysis reported for DAS28 (ESR) response.||||0.047
71013440|NCT01050998|141533744|SUPERIORITY_OR_OTHER||Percent difference|||||0.237|||||||Log Rank|||European region: Analysis reported for DAS28 (CRP) response.||||0.237
71013441|NCT01050998|141533744|SUPERIORITY_OR_OTHER|||||||0.005|||||||Log Rank|||European region: Analysis reported for DAS28 (CRP) response.||||0.005
71013442|NCT01050998|141533744|SUPERIORITY_OR_OTHER|||||||0.134|||||||Log Rank|||European region: Analysis reported for DAS28 (CRP) response.||||0.134
70928768|NCT04800211|141353089|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-26.41|||<|0.0001|TWO_SIDED|95.0|-31.716|-21.103|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-21.103|-31.716|<.0001
70928769|NCT04800211|141353089|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-7.021||||0.028|TWO_SIDED|95.0|-13.278|-0.763|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-0.763|-13.278|0.0280
70941441|NCT04839289|141383622|OTHER||||||<|0.01666667||||||When adjusted for multiple comparisons, the p-value must be \</= to .01666667 (.05/3).|t-test, 2 sided|||"Null hypothesis: Satisfaction with hearing aid performance and features would not be different between any of the three study hearing aids when measured with subjective hearing aid satisfaction questionnaire.~Analysis was done after all three home trials completed so all three sets of study devices could be compared."||||<.01666667
71013443|NCT01050998|141533744|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||European region: Analysis reported for DAS28 (CRP) response.||||<0.001
71013444|NCT01050998|141533744|SUPERIORITY_OR_OTHER|||||||0.265|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (CRP) response.||||0.265
71013445|NCT01050998|141533744|SUPERIORITY_OR_OTHER|||||||0.013|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (CRP) response.||||0.013
71013446|NCT01050998|141533744|SUPERIORITY_OR_OTHER|||||||0.952|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (CRP) response.||||0.952
71013447|NCT01050998|141533744|SUPERIORITY_OR_OTHER|||||||0.004|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (CRP) response.||||0.004
71013448|NCT01050998|141533744|SUPERIORITY_OR_OTHER|||||||0.246|||||||Log Rank|||European region: Analysis reported for DAS28 (ESR) response.||||0.246
71013449|NCT01050998|141533744|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||European region: Analysis reported for DAS28 (ESR) response.||||<0.001
71013450|NCT01050998|141533744|SUPERIORITY_OR_OTHER|||||||0.126|||||||Log Rank|||European region: Analysis reported for DAS28 (ESR) response.||||0.126
71013451|NCT01050998|141533744|SUPERIORITY_OR_OTHER|||||||0.831|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (ESR) response.||||0.831
71013452|NCT01050998|141533744|SUPERIORITY_OR_OTHER|||||||0.005|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (ESR) response.||||0.005
71013453|NCT01050998|141533744|SUPERIORITY_OR_OTHER|||||||0.125|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (ESR) response.||||0.125
71013454|NCT01050998|141533744|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (ESR) response.||||<0.001
71013455|NCT01050998|141533745|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|1.15||||0.486|TWO_SIDED|95.0|0.78|1.69|||Exponential,Weibull and Log normal model||Ratio greater than (\>) 1 favored mavrilimumab.|Analysis reported for DAS28 (ESR) response.||1.69|0.78|0.486
71013456|NCT01050998|141533745|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|1.54||||0.015|TWO_SIDED|95.0|1.09|2.18|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (ESR) response.||2.18|1.09|0.015
71047860|NCT03822832|141604823|OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|3.8||0.8613|TWO_SIDED|90.0|-5.7|7.0|||Mixed Models Analysis|See endpoint description for model description.|Difference calculated as Spesolimab - Placebo.|||7.0|-5.7|0.8613
71013457|NCT01050998|141533745|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|1.65||||0.006|TWO_SIDED|95.0|1.15|2.36|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (ESR) response.||2.36|1.15|0.006
71013458|NCT01050998|141533745|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|2.09|||<|0.001|TWO_SIDED|95.0|1.49|2.93|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (ESR) response.||2.93|1.49|<0.001
71013459|NCT01050998|141533745|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|0.97||||0.906|TWO_SIDED|95.0|0.61|1.55|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (CRP) response.||1.55|0.61|0.906
71013460|NCT01050998|141533745|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|1.89|||<|0.001|TWO_SIDED|95.0|1.31|2.71|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (CRP) response.||2.71|1.31|<0.001
71013461|NCT01050998|141533745|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|1.26||||0.272|TWO_SIDED|95.0|0.83|1.91|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (CRP) response.||1.91|0.83|0.272
71013462|NCT01050998|141533745|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|1.91|||<|0.001|TWO_SIDED|95.0|1.34|2.72|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (CRP) response.||2.72|1.34|<0.001
71013463|NCT01050998|141533746|SUPERIORITY_OR_OTHER||Percent difference|4.7||||0.589|TWO_SIDED|95.0|-12.1|22.0|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR20: p-value was calculated using a two-tailed Fisher's exact test.||22.0|-12.1|0.589
71047861|NCT03822832|141604824|OTHER||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|14.0||0.8754|TWO_SIDED|90.0|-25.8|21.4|||Mixed Models Analysis|See endpoint description for model description.|Difference calculated as Spesolimab - Placebo.|||21.4|-25.8|0.8754
70928770|NCT04800211|141353089|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-5.902||||0.0972|TWO_SIDED|95.0|-12.881|1.077|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||1.077|-12.881|0.0972
70928771|NCT04800211|141353089|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-25.771|||<|0.0001|TWO_SIDED|95.0|-37.189|-14.353|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-14.353|-37.189|<.0001
70928772|NCT04800211|141353089|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-20.019||||0.0005|TWO_SIDED|95.0|-32.833|-7.205|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-7.205|-32.833|0.0005
70928773|NCT04800211|141353089|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-18.463||||0.0002|TWO_SIDED|95.0|-29.825|-7.101|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-7.101|-29.825|0.0002
70928774|NCT04800211|141353089|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-20.997||||0.0002|TWO_SIDED|95.0|-33.619|-8.375|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-8.375|-33.619|0.0002
70941442|NCT02418819|141383629|SUPERIORITY_OR_OTHER||LSMean difference from placebo|-1.9|STANDARD_ERROR_OF_MEAN|2.032||0.8243|ONE_SIDED|92.0|-4.78||||ANCOVA|One(1)-sided P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day -2 assessment.|||-4.78|0.8243
71013464|NCT01050998|141533746|SUPERIORITY_OR_OTHER||Percent difference|20.2||||0.032||95.0|2.8|36.7|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR20: p-value was calculated using a two-tailed Fisher's exact test.||36.7|2.8|0.032
71013465|NCT01050998|141533746|SUPERIORITY_OR_OTHER||Percent difference|0.5||||1|TWO_SIDED|95.0|-16.0|18.0|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR20: p-value was calculated using a two-tailed Fisher's exact test.||18.0|-16.0|1.000
71013466|NCT01050998|141533746|SUPERIORITY_OR_OTHER||Percent difference|33.3|||<|0.001|TWO_SIDED|95.0|15.6|48.6|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR20: p-value was calculated using a two-tailed Fisher's exact test.||48.6|15.6|<0.001
71013467|NCT01050998|141533746|SUPERIORITY_OR_OTHER||Percent difference|8.9||||0.212|TWO_SIDED|95.0|-3.5|23.6|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR50: p-value was calculated using a two-tailed Fisher's exact test.||23.6|-3.5|0.212
71013468|NCT01050998|141533746|SUPERIORITY_OR_OTHER||Percent difference|18.7||||0.011|TWO_SIDED|95.0|4.8|34.0|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR50: p-value was calculated using a two-tailed Fisher's exact test.||34.0|4.8|0.011
71013469|NCT01050998|141533746|SUPERIORITY_OR_OTHER||Percent difference|4.7||||0.446|TWO_SIDED|95.0|-7.0|19.1|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR50: p-value was calculated using a two-tailed Fisher's exact test.||19.1|-7.0|0.446
71013470|NCT01050998|141533746|SUPERIORITY_OR_OTHER||Percent difference|22.1||||0.003|TWO_SIDED|95.0|7.6|37.8|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR50: p-value was calculated using a two-tailed Fisher's exact test.||37.8|7.6|0.003
71047862|NCT03822832|141604825|OTHER||Risk Difference (RD)|-0.03|||||TWO_SIDED|90.0|-0.254|0.176||||CIs are calculated using the method of Wilson and Newcombe.|Difference calculated as Spesolimab - Placebo|Risk difference at week 4||0.176|-0.254|
71013471|NCT01050998|141533746|SUPERIORITY_OR_OTHER||Percent difference|-1.3||||1|TWO_SIDED|95.0|-8.9|9.7|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR70: p-value was calculated using a two-tailed Fisher's exact test.||9.7|-8.9|1.000
71013472|NCT01050998|141533746|SUPERIORITY_OR_OTHER||Percent difference|4.8||||0.317|TWO_SIDED|95.0|-4.1|17.5|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR70: p-value was calculated using a two-tailed Fisher's exact test.||17.5|-4.1|0.317
71013473|NCT01050998|141533746|SUPERIORITY_OR_OTHER||Percent difference|0.8||||1|TWO_SIDED|95.0|-7.2|12.1|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR70: p-value was calculated using a two-tailed Fisher's exact test.||12.1|-7.2|1.000
70928775|NCT04800211|141353089|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-20.508|||<|0.0001|TWO_SIDED|95.0|-29.061|-11.955|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-11.955|-29.061|<.0001
70928776|NCT04800211|141353089|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.978||||0.8504|TWO_SIDED|95.0|-9.216|11.172|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||11.172|-9.216|0.8504
70928777|NCT04800211|141353090|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-31.257|||<|0.0001|TWO_SIDED|95.0|-41.957|-20.557|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-20.557|-41.957|<.0001
70928778|NCT04800211|141353090|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-29.862|||<|0.0001|TWO_SIDED|95.0|-44.234|-15.491|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-15.491|-44.234|<.0001
70941443|NCT02418819|141383629|SUPERIORITY_OR_OTHER||LSMean difference from placebo|-2.14|STANDARD_ERROR_OF_MEAN|2.252||0.8277|ONE_SIDED|92.0|-5.33||||ANCOVA|One(1)-side P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day -2 assessment.|||-5.33|0.8277
71013474|NCT01050998|141533746|SUPERIORITY_OR_OTHER||Percent difference|9.5||||0.106|TWO_SIDED|95.0|-0.5|23.5|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR70: p-value was calculated using a two-tailed Fisher's exact test.||23.5|-0.5|0.106
71047863|NCT03822832|141604825|OTHER||Risk Difference (RD)|0.247|||||TWO_SIDED|90.0|0.053|0.396||||CIs are calculated using the method of Wilson and Newcombe.|Difference calculated as Spesolimab - Placebo|Risk difference at week 16||0.396|0.053|
71047864|NCT03822832|141604826|OTHER||Risk Difference (RD)|-0.02|||||TWO_SIDED|90.0|-0.204|0.117||||CIs are calculated using the method of Wilson and Newcombe.|Difference calculated as Spesolimab - Placebo|Risk difference at week 4||0.117|-0.204|
71047865|NCT03822832|141604826|OTHER||Risk Difference (RD)|0.096|||||TWO_SIDED|90.0|-0.08|0.232||||CIs are calculated using the method of Wilson and Newcombe.|Difference calculated as Spesolimab - Pl|Risk difference at week 16||0.232|-0.080|
71047866|NCT03822832|141604827|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|8.7||0.99|TWO_SIDED|90.0|-14.6|14.8|||Mixed Models Analysis|See endpoint description for model description.|Difference calculated as Spesolimab - Placebo.|||14.8|-14.6|0.9900
71047867|NCT03822832|141604828|OTHER||Mean Difference (Final Values)|-14.9|STANDARD_ERROR_OF_MEAN|12.1||0.2266|TWO_SIDED|90.0|-35.2|5.5|||Mixed Models Analysis|See endpoint description for model description.|Difference calculated as Spesolimab - Placebo.|||5.5|-35.2|0.2266
71047868|NCT03822832|141604829|OTHER||Risk Difference (RD)|0.005|||||TWO_SIDED|90.0|-0.159|0.12||||CIs are calculated using the method of Wilson and Newcombe.|Difference calculated as Spesolimab - Placebo|Risk difference at week 4||0.120|-0.159|
70928779|NCT04800211|141353090|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-31.512|||<|0.0001|TWO_SIDED|95.0|-46.971|-16.053|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-16.053|-46.971|<.0001
70928780|NCT04800211|141353090|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-37.197|||<|0.0001|TWO_SIDED|95.0|-47.522|-26.872|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-26.872|-47.522|<.0001
70928781|NCT04800211|141353090|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-31.442|||<|0.0001|TWO_SIDED|95.0|-44.96|-17.923|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-17.923|-44.960|<.0001
70928782|NCT04800211|141353090|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-28.597||||0.0002|TWO_SIDED|95.0|-43.34|-13.853|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-13.853|-43.340|0.0002
70941444|NCT02418819|141383629|SUPERIORITY_OR_OTHER||LSMean difference from placebo|-4.01|STANDARD_ERROR_OF_MEAN|1.902||0.981|ONE_SIDED|92.0|-6.7||||ANCOVA|One(1)-side P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day -2 assessment.|||-6.70|0.9810
70941445|NCT02418819|141383630|SUPERIORITY_OR_OTHER||LSMean difference from placebo|0.0129|STANDARD_ERROR_OF_MEAN|0.286||0.4821|ONE_SIDED|99.0|-0.6682||||ANCOVA|One (1)-side P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day 0 assessment.|||-0.6682|0.4821
71013475|NCT01050998|141533747|SUPERIORITY_OR_OTHER||Percent difference|1.0||||1|TWO_SIDED|95.0|-17.7|20.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||20.4|-17.7|1.000
71013476|NCT01050998|141533747|SUPERIORITY_OR_OTHER||Percent difference|16.1||||0.12|TWO_SIDED|95.0|-3.1|34.4|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||34.4|-3.1|0.120
71047869|NCT03822832|141604829|OTHER||Risk Difference (RD)|0.091|||||TWO_SIDED|90.0|-0.05|0.207||||CIs are calculated using the method of Wilson and Newcombe.|Difference calculated as Spesolimab - Placebo|Risk difference at week 16||0.207|-0.050|
71013477|NCT01050998|141533747|SUPERIORITY_OR_OTHER||Percent difference|1.0||||1|TWO_SIDED|95.0|-17.7|20.4|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||20.4|-17.7|1.000
71047870|NCT02737332|141604831|EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|Geometric mean ratio of treatments|1.019||||0.4879|TWO_SIDED|90.0|0.964|1.077||One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|||1.077|0.964|0.4879
71013478|NCT01050998|141533747|SUPERIORITY_OR_OTHER||Percent difference|29.2||||0.005|TWO_SIDED|95.0|9.7|46.1|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||46.1|9.7|0.005
70850356|NCT00947882|141188492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.97||||0.0231||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 4. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 20 mg and Placebo at Month 4."|ANCOVA of the change from baseline in IPSS at Month 4 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.0231
70850357|NCT00947882|141188492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.1638||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 4. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 10 mg and Placebo at Month 4."|ANCOVA of the change from baseline in IPSS at Month 4 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.1638
70850358|NCT00947882|141188492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14||||0.1941||||||P-values based on Williams' extended trend test of comparisons vs. placebo at Month 5. No adjustment for multiple comparison was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 30 mg and Placebo at Month 5."|ANCOVA of the change from baseline in IPSS at Month 5 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.1941
70850359|NCT00947882|141188492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54||||0.1083||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 5. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 20 mg and Placebo at Month 5."|ANCOVA of the change from baseline in IPSS at Month 5 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.1083
70850360|NCT00947882|141188492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95||||0.2782||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 5. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 10 mg and Placebo at Month 5."|ANCOVA of the change from baseline in IPSS at Month 5 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.2782
70850361|NCT00947882|141188492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15||||0.1562||||||P-values based on Williams' extended trend test of comparison vs. placebo at Month 6. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 30 mg and Placebo at Month 6."|ANCOVA of the change from baseline in IPSS at Month 6 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.1562
70850362|NCT00947882|141188492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24||||0.1736||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 6. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 20 mg and Placebo at Month 6."|ANCOVA of the change from baseline in IPSS at Month 6 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.1736
70850363|NCT00947882|141188492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84||||0.3132||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 6. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 10 mg and Placebo at Month 6."|ANCOVA of the change from baseline in IPSS at Month 6 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.3132
70850364|NCT00947882|141188493|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.2034|TWO_SIDED|95.0|0.814|2.628||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 3."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 30 mg and Placebo at Month 3."|||2.628|0.814|0.2034
71013479|NCT01050998|141533747|SUPERIORITY_OR_OTHER||Percent difference|20.9||||0.382|TWO_SIDED|95.0|-16.4|55.9|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||55.9|-16.4|0.382
70928783|NCT04800211|141353090|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-30.054|||<|0.0001|TWO_SIDED|95.0|-40.943|-19.166|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-19.166|-40.943|<.0001
70928784|NCT04800211|141353090|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-5.904||||0.2667|TWO_SIDED|95.0|-16.37|4.563|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||4.563|-16.370|0.2667
70928785|NCT04800211|141353090|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|8.767||||0.2085|TWO_SIDED|95.0|-4.95|22.485|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||22.485|-4.950|0.2085
70928786|NCT04800211|141353090|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|12.455||||0.1041|TWO_SIDED|95.0|-2.595|27.505|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||27.505|-2.595|0.1041
70928787|NCT04800211|141353090|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-25.353||||0.0058|TWO_SIDED|95.0|-45.41|-5.295|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-5.295|-45.410|0.0058
71047871|NCT02737332|141604832|OTHER|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|Geometric mean ratio|0.994||||0.3642|TWO_SIDED|90.0|0.0451|2.192||One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|||2.192|0.0451|0.3642
71047872|NCT02737332|141604832|EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|Geometric mean ratio|0.81||||0.4069|TWO_SIDED|90.0|0.338|1.939||One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|||1.939|0.338|0.4069
71013480|NCT01050998|141533747|SUPERIORITY_OR_OTHER||Percent difference|39.0||||0.087|TWO_SIDED|95.0|-2.7|69.6|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||69.6|-2.7|0.087
71013481|NCT01050998|141533747|SUPERIORITY_OR_OTHER||Percent difference|-1.3||||1|TWO_SIDED|95.0|-33.7|35.7|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||35.7|-33.7|1.000
70850365|NCT00947882|141188493|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.1748|TWO_SIDED|95.0|0.834|2.71||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 3."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 20 mg and Placebo at Month 3."|||2.710|0.834|0.1748
70850366|NCT00947882|141188493|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.0658|TWO_SIDED|95.0|0.964|3.195||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 3."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 10 mg and Placebo at Month 3."|||3.195|0.964|0.0658
70850367|NCT00947882|141188493|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77||||0.0587|TWO_SIDED|95.0|0.979|3.184||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 4."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 30 mg and Placebo at Month 4."|||3.184|0.979|0.0587
70850368|NCT00947882|141188493|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.049|TWO_SIDED|95.0|1.003|3.283||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 4."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 20 mg and Placebo at Month 4."|||3.283|1.003|0.0490
70850369|NCT00947882|141188493|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.2742|TWO_SIDED|95.0|0.774|2.464||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 4."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 10 mg and Placebo at Month 4."|||2.464|0.774|0.2742
70850370|NCT00947882|141188493|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.4206|TWO_SIDED|95.0|0.706|2.304||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 5."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 30 mg and Placebo at Month 5."|||2.304|0.706|0.4206
70850371|NCT00947882|141188493|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.5494|TWO_SIDED|95.0|0.664|2.16||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 5."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 20 mg and Placebo at Month 5."|||2.160|0.664|0.5494
70850372|NCT00947882|141188493|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.7586|TWO_SIDED|95.0|0.609|1.975||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 5."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 10 mg and Placebo at Month 5."|||1.975|0.609|0.7586
70850373|NCT00947882|141188493|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.1946|TWO_SIDED|95.0|0.816|2.717||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 6."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 30 mg and Placebo at Month 6."|||2.717|0.816|0.1946
70850374|NCT00947882|141188493|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.538|TWO_SIDED|95.0|0.667|2.174||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 6."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 20 mg and Placebo at Month 6."|||2.174|0.667|0.5380
70850375|NCT00947882|141188493|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.4263|TWO_SIDED|95.0|0.702|2.308||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 6."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 10 mg and Placebo at Month 6."|||2.308|0.702|0.4263
70850376|NCT00947882|141188494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.76||||0.4607|TWO_SIDED|95.0|-10.113|4.59||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 30 mg and Placebo at Month 3."|||4.590|-10.113|0.4607
70850377|NCT00947882|141188494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.24||||0.3876|TWO_SIDED|95.0|-10.614|4.128||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 20 mg and Placebo at Month 3."|||4.128|-10.614|0.3876
71013482|NCT01050998|141533747|SUPERIORITY_OR_OTHER||Percent difference|51.5||||0.028|TWO_SIDED|95.0|8.2|77.0|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||77.0|8.2|0.028
71013483|NCT01050998|141533747|SUPERIORITY_OR_OTHER||Percent difference|11.1||||0.175|TWO_SIDED|95.0|-2.9|27.9|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||27.9|-2.9|0.175
71013484|NCT01050998|141533747|SUPERIORITY_OR_OTHER||Percent difference|17.3||||0.026|TWO_SIDED|95.0|2.4|34.1|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||34.1|2.4|0.026
71013485|NCT01050998|141533747|SUPERIORITY_OR_OTHER||Percent difference|8.5||||0.271|TWO_SIDED|95.0|-5.1|24.9|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||24.9|-5.1|0.271
71047873|NCT02737332|141604832|EQUIVALENCE|One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|Geometric mean ratio|1.039||||0.7186|TWO_SIDED|90.0|0.412|2.617||The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|||2.617|0.412|0.7186
71047874|NCT02737332|141604833|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71047875|NCT02737332|141604834|EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|Geometric mean ratio|0.999||||0.9211|TWO_SIDED|90.0|0.98|1.018||One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.||ANOVA-model-based Least-Square Mean|1.018|0.980|0.9211
71047876|NCT02737332|141604834|EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|Geometric mean ratio|1.168||||0.3037|TWO_SIDED|90.0|0.9|1.515||One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|||1.515|0.900|0.3037
71047877|NCT02737332|141604834|EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|Geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.0||One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|||1.000|1.000|
71013486|NCT01050998|141533747|SUPERIORITY_OR_OTHER||Percent difference|18.8||||0.021|TWO_SIDED|95.0|3.4|36.0|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||36.0|3.4|0.021
71047878|NCT02737332|141604835|OTHER|||||||0.5495|||||||ANOVA|||||||0.5495
71047879|NCT02737332|141604835|OTHER|||||||0.2616|||||||ANOVA|||||||0.2616
71047880|NCT02737332|141604835|OTHER|||||||0.3632|||||||ANOVA|||||||0.3632
71047881|NCT02737332|141604835|OTHER|||||||0.3393|||||||ANOVA|||||||0.3393
71047882|NCT02737332|141604839|OTHER|||||||0.1917|||||||ANOVA|||||||0.1917
71013487|NCT01050998|141533747|SUPERIORITY_OR_OTHER||Percent difference|-0.7||||1|TWO_SIDED|95.0|-27.0|34.8|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||34.8|-27.0|1.000
71013488|NCT01050998|141533747|SUPERIORITY_OR_OTHER||Percent difference|25.7||||0.283|TWO_SIDED|95.0|-8.8|63.2|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||63.2|-8.8|0.283
71013489|NCT01050998|141533747|SUPERIORITY_OR_OTHER||Percent difference|-11.8||||0.529|TWO_SIDED|95.0|-35.0|22.7|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||22.7|-35.0|0.529
71013490|NCT01050998|141533747|SUPERIORITY_OR_OTHER||Percent difference|38.2||||0.059|TWO_SIDED|95.0|1.6|71.2|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||71.2|1.6|0.059
71013491|NCT01050998|141533747|SUPERIORITY_OR_OTHER||Percent difference|1.1||||1|TWO_SIDED|95.0|-7.0|14.2|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||14.2|-7.0|1.000
71013492|NCT01050998|141533747|SUPERIORITY_OR_OTHER||Percent difference|5.8||||0.242|TWO_SIDED|95.0|-3.7|19.4|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||19.4|-3.7|0.242
71013493|NCT01050998|141533747|SUPERIORITY_OR_OTHER||Percent difference|3.7||||0.41|TWO_SIDED|95.0|-5.1|16.9|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||16.9|-5.1|0.410
71013494|NCT01050998|141533747|SUPERIORITY_OR_OTHER||Percent difference|13.9||||0.03|TWO_SIDED|95.0|2.7|29.5|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||29.5|2.7|0.030
71047883|NCT03979820|141604859|OTHER||Ratio of geometric mean TSFs|544.36|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|340.57|870.09|||ANOVA||"The arm Phenelzine/Phenelzine + Tyramine represented the numerator. The arm Placebo/Placebo + Tyramine represented the denominator."|"The statistical model used for the analysis of the primary endpoint was an analysis of variance (ANOVA) model on the logarithmic scale for each treatment relative to placebo.~TSF was log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the fixed effects 'treatment'."||870.09|340.57|
71047884|NCT03979820|141604859|OTHER||Ratio of geometric mean TSFs|123.22|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|77.09|196.95|||ANOVA||"The arm 10 mg BI 1467335/10 mg BI 1467335 + Tyramine represented the numerator.~The arm Placebo/Placebo + Tyramine represented the denominator."|"The statistical model used for the analysis of the primary endpoint was an analysis of variance (ANOVA) model on the logarithmic scale for each treatment relative to placebo.~TSF was log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the fixed effects 'treatment'."||196.95|77.09|
71013495|NCT01050998|141533747|SUPERIORITY_OR_OTHER||Percent difference|-11.8||||0.529|TWO_SIDED|95.0|-35.0|22.7|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||22.7|-35.0|0.529
71013496|NCT01050998|141533747|SUPERIORITY_OR_OTHER||Percent difference|0.7||||1|TWO_SIDED|95.0|-26.7|39.5|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||39.5|-26.7|1.000
71047885|NCT04764630|141604892|SUPERIORITY|To demonstrate an increase in naloxone concentration, the lower bound of the one-sided 97.79% interval for the geometric mean ratio must exclude 1. The results will be transformed back to the original scale by exponentiation to provide treatment geometric means.|Geometric mean ratio|1.95||||0.002|ONE_SIDED|95.6|1.28|||Testing will be conducted sequentially (i.e., start at the initial time and progress forward, stopping if success is achieved) at a 1-sided 0.0221 significance level since an increase in naloxone exposure is expected.|t-test, 1 sided||Data is shown for 10-minute timepoint (first time point tested where an increased was observed). This compares results from the 4 naloxone dose arm (1 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Up to three different time points have been pre-specified for the comparison (10, 12.5, and 15 min). Time points will be evaluated from earliest to latest time. Testing will proceed until either one passes or all pre-specified time points fail. Subject-level naloxone concentrations will be log-transformed. Naloxone concentrations below the lower limit of quantification will result in that time point from that subject being removed for comparisons involving that treatment arm.|This was the first timepoint in the comparison that showed an increase in the 4 naloxone dose arm (1 every 2.5 min) compared to the 2 naloxone dose arm (1 every 2.5 min) and is the reported outcome for this endpoint.||1.28|0.002
71047886|NCT04764630|141604893|SUPERIORITY|To demonstrate an increase in naloxone concentration, the lower bound of the one-sided 97.79% interval for the geometric mean ratio must exclude 1. The results will be transformed back to the original scale by exponentiation to provide treatment geometric means.|Geometric mean ratio|1.98||||0.018|ONE_SIDED|95.6|1.03|||Testing will be conducted sequentially (i.e., start at the initial time and progress forward, stopping if success is achieved) at a 1-sided 0.0221 significance level since an increase in naloxone exposure is expected.|t-test, 1 sided||Data is shown for 4.5-minute timepoint (first time point tested where an increased was observed). This compares results from the 4 naloxone dose arm (2 doses every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Up to three different time points have been pre-specified for the comparison (4.5, 7, and 10 minutes). Time points will be evaluated from earliest to latest time. Testing will proceed until either one passes or all pre-specified time points fail. Subject-level naloxone concentrations will be log-transformed. Naloxone concentrations below the lower limit of quantification will result in that time point from that subject being removed for comparisons involving that treatment arm.|This was the first timepoint in the comparison that showed an increase in the 4 naloxone dose arm (2 doses every 2.5 min) compared to the 2 naloxone dose arm (1 every 2.5 min) and is the reported outcome for this endpoint.||1.03|0.018
71047887|NCT04764630|141604894|SUPERIORITY|To demonstrate an increase in naloxone concentration, the lower bound of the one-sided 97.79% interval for the geometric mean ratio must exclude 1. The results will be transformed back to the original scale by exponentiation to provide treatment geometric means.|Geometric mean ratio|1.69||||0.013|ONE_SIDED|95.6|1.06|||Testing will be conducted sequentially (i.e., start at the initial time and progress forward, stopping if success is achieved) at a 1-sided 0.0221 significance level since an increase in naloxone exposure is expected.|t-test, 1 sided||Data is shown for 4.5-minute timepoint (first time point tested where an increased was observed). This compares results from the 4 naloxone dose arm (2 doses every 2.5 min) (numerator) with the 4 naloxone dose arm (1 every 2.5 min) (denominator).|Up to three different time points have been pre-specified for the comparison (4.5, 7, and 10 minutes). Time points will be evaluated from earliest to latest time. Testing will proceed until either one passes or all pre-specified time points fail. Subject-level naloxone concentrations will be log-transformed. Naloxone concentrations below the lower limit of quantification will result in that time point from that subject being removed for comparisons involving that treatment arm.|This was the first timepoint in the comparison that showed an increase in the 4 naloxone dose arm (2 doses every 2.5 min) compared to the 4 naloxone dose arm (1 every 2.5 min) and is the reported outcome for this endpoint.||1.06|0.013
71047888|NCT04764630|141604895|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.89||||0.1|TWO_SIDED|90.0|0.78|1.0|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (1 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for Cmax will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||1.00|0.78|0.10
71047889|NCT04764630|141604895|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.77||||0.018|TWO_SIDED|90.0|0.65|0.92|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (2 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for Cmax will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.92|0.65|0.018
71104068|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.97|||||TWO_SIDED|95.0|3.42|4.61||||||No risk subjects.||4.61|3.42|
71104069|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.72|||||TWO_SIDED|95.0|1.02|7.31||||||At risk subjects.||7.31|1.02|
71104070|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|3.5|||||TWO_SIDED|95.0|1.85|6.62||||||At risk subjects.||6.62|1.85|
71104071|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|5.26|||||TWO_SIDED|95.0|2.32|12.0||||||At risk subjects.||12|2.32|
71013497|NCT01050998|141533747|SUPERIORITY_OR_OTHER||Percent difference|-11.8||||1|TWO_SIDED|95.0|-37.5|22.6|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||22.6|-37.5|1.000
71013498|NCT01050998|141533749|SUPERIORITY_OR_OTHER||Adjusted Mean difference|14.05|STANDARD_ERROR_OF_MEAN|7.162||0.051|TWO_SIDED|95.0|-0.05|28.15|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||28.15|-0.05|0.051
71013499|NCT01050998|141533749|SUPERIORITY_OR_OTHER||Adjusted Mean difference|21.23|STANDARD_ERROR_OF_MEAN|7.028||0.003|TWO_SIDED|95.0|7.39|35.07|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||35.07|7.39|0.003
71013500|NCT01050998|141533749|SUPERIORITY_OR_OTHER||Adjusted Mean difference|7.09|STANDARD_ERROR_OF_MEAN|7.136||0.322|TWO_SIDED|95.0|-6.96|21.14|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||21.14|-6.96|0.322
71013501|NCT01050998|141533749|SUPERIORITY_OR_OTHER||Adjusted Mean difference|32.03|STANDARD_ERROR_OF_MEAN|7.085|<|0.001|TWO_SIDED|95.0|18.08|45.98|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||45.98|18.08|<0.001
71013502|NCT01050998|141533750|SUPERIORITY_OR_OTHER||Adjusted Mean difference|14.49|STANDARD_ERROR_OF_MEAN|7.981||0.071|TWO_SIDED|95.0|-1.24|30.22|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for European region.||30.22|-1.24|0.071
71013503|NCT01050998|141533750|SUPERIORITY_OR_OTHER||Adjusted mean difference|19.43|STANDARD_ERROR_OF_MEAN|7.798||0.013|TWO_SIDED|95.0|4.06|34.8|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for European region.||34.80|4.06|0.013
71013504|NCT01050998|141533750|SUPERIORITY_OR_OTHER||Adjusted mean difference|7.84|STANDARD_ERROR_OF_MEAN|7.873||0.32|TWO_SIDED|95.0|-7.68|23.36|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for European region.||23.36|-7.68|0.320
71013505|NCT01050998|141533750|SUPERIORITY_OR_OTHER||Adjusted mean difference|31.37|STANDARD_ERROR_OF_MEAN|7.873|<|0.001|TWO_SIDED|95.0|15.85|46.89|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for European region.||46.89|15.85|<0.001
71013506|NCT01050998|141533750|SUPERIORITY_OR_OTHER||Adjusted mean difference|12.11|STANDARD_ERROR_OF_MEAN|17.089||0.483|TWO_SIDED|95.0|-22.41|46.64|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for Japanese region.||46.64|-22.41|0.483
71013507|NCT01050998|141533750|SUPERIORITY_OR_OTHER||Adjusted mean difference|31.24|STANDARD_ERROR_OF_MEAN|17.089||0.075|TWO_SIDED|95.0|-3.28|65.77|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for Japanese region.||65.77|-3.28|0.075
71013508|NCT01050998|141533750|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.22|STANDARD_ERROR_OF_MEAN|17.872||0.815|TWO_SIDED|95.0|-31.89|40.32|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for Japanese region.||40.32|-31.89|0.815
71013509|NCT01050998|141533750|SUPERIORITY_OR_OTHER||Adjusted mean difference|36.11|STANDARD_ERROR_OF_MEAN|17.089||0.041|TWO_SIDED|95.0|1.58|70.63|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for Japanese region.||70.63|1.58|0.041
71013510|NCT00620191|141533783|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.7|STANDARD_DEVIATION|1.92||0.05|TWO_SIDED||||||t-test, 2 sided||The difference is the value for the metformin arm minus the value for the placebo arm.|||||0.05
71013511|NCT00620191|141533783|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.1|STANDARD_DEVIATION|1.36||0.05|TWO_SIDED||||||ANCOVA|adjusted for baseline ADAS-Cog value|The difference is the value for the metformin arm minus the value for the placebo arm.|||||0.05
71013512|NCT00620191|141533784|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.98|STANDARD_DEVIATION|1.01||0.06|TWO_SIDED||||||t-test, 2 sided||The difference is the value for the metformin arm minus the value for the placebo arm.|||||0.06
71013513|NCT00620191|141533784|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|STANDARD_DEVIATION|0.91||0.34|TWO_SIDED||||||ANCOVA|adjusted for baseline ADAS-Cog score.|The difference is the value for the metformin arm minus the value for the placebo arm.|||||0.34
71013514|NCT00620191|141533785|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.0|STANDARD_DEVIATION|2.14||0.36|TWO_SIDED||||||t-test, 2 sided||The difference is the value for the metformin arm minus the value for the placebo arm.|||||0.36
71013515|NCT00620191|141533786|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.09|STANDARD_DEVIATION|4.73||0.34|TWO_SIDED||||||t-test, 2 sided||The difference is the value for the metformin arm minus the value for the placebo arm.|||||0.34
71104072|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.55|||||TWO_SIDED|95.0|1.21|1.97||||||No risk subjects.||1.97|1.21|
70928788|NCT04800211|141353090|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-38.63||||0.001|TWO_SIDED|95.0|-65.062|-12.197|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-12.197|-65.062|0.0010
70928789|NCT04800211|141353090|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-43.967||||0.0005|TWO_SIDED|95.0|-72.443|-15.491|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-15.491|-72.443|0.0005
71047890|NCT04764630|141604895|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.87||||0.12|TWO_SIDED|90.0|0.75|1.01|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (2 every 2.5 min) (numerator) with the 4 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for Cmax will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||1.01|0.75|0.12
71104073|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.51|||||TWO_SIDED|95.0|1.26|1.82||||||No risk subjects||1.82|1.26|
70928790|NCT04800211|141353090|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-31.293||||0.0003|TWO_SIDED|95.0|-51.159|-11.428|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-11.428|-51.159|0.0003
70928791|NCT04800211|141353090|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-40.209||||0.0004|TWO_SIDED|95.0|-65.941|-14.477|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-14.477|-65.941|0.0004
71104074|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.9|||||TWO_SIDED|95.0|1.52|2.38||||||No risk subjects||2.38|1.52|
71104075|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.76|||||TWO_SIDED|95.0|0.57|5.4||||||At risk subjects||5.4|0.57|
71104076|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.78|||||TWO_SIDED|95.0|1.09|2.89||||||At risk subjects||2.89|1.09|
70928792|NCT04800211|141353090|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-41.052||||0.0011|TWO_SIDED|95.0|-68.965|-13.138|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-13.138|-68.965|0.0011
70928793|NCT04800211|141353090|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-42.509|||<|0.0001|TWO_SIDED|95.0|-60.902|-24.116|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-24.116|-60.902|<.0001
70928794|NCT04800211|141353090|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-2.915||||0.7835|TWO_SIDED|95.0|-23.855|18.025|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||18.025|-23.855|0.7835
70928795|NCT04800211|141353091|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)|Mean Difference (Net)|-0.769||||0.0002|TWO_SIDED|95.0|-1.228|-0.309|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)||-0.309|-1.228|0.0002
70941446|NCT02418819|141383630|SUPERIORITY_OR_OTHER||LSMean difference from placebo|-0.2974|STANDARD_ERROR_OF_MEAN|0.276||0.8576|ONE_SIDED|99.0|-0.9547||||ANCOVA|One (1)-side P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day 0 assessment.|||-0.9547|0.8576
71013516|NCT00145795|141533792|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to examine the significance of the difference in mean absolute increase in CD4+ count at 3 months. Under the null hypothesis, CD4+ increase is similar for both treatment groups.||||0.81
71013517|NCT00145795|141533793|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||||||Significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to examine the significance of the difference in mean absolute increase in CD4+ count at 6 months. Under the null hypothesis, CD4+ increase is similar for both treatment groups.||||0.03
71013518|NCT00145795|141533794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD4+ memory cell population at 3 months. Under the null hypothesis, percent CD4+ memory cell apoptosis is similar for both treatment groups.||||0.08
71013519|NCT00145795|141533795|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD4+ naïve cell population at 3 months. Under the null hypothesis, percent CD4+ naïve cell apoptosis is similar for both treatment groups.||||0.29
71013520|NCT00145795|141533796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD4+ memory cell population at 6 months. Under the null hypothesis, percent CD4+ memory cell apoptosis is similar for both treatment groups.||||0.29
71013521|NCT00145795|141533797|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD4+ naïve cell population at 6 months. Under the null hypothesis, percent CD4+ naïve cell apoptosis is similar for both treatment groups.||||0.04
70928796|NCT04800211|141353091|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)|Mean Difference (Net)|-0.52||||0.0175|TWO_SIDED|95.0|-0.972|-0.068|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)||-0.068|-0.972|0.0175
70928797|NCT04800211|141353092|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)|Mean Difference (Net)|2.408||||0.0362|TWO_SIDED|95.0|0.11|4.705|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)||4.705|0.110|0.0362
70928798|NCT04800211|141353092|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.692||||0.2142|TWO_SIDED|95.0|-0.569|3.953|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||3.953|-0.569|0.2142
71013522|NCT00145795|141533798|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD8+ cell population at 3 months. Under the null hypothesis, percent CD8+ cell apoptosis is similar for both treatment groups.||||0.21
71013523|NCT00145795|141533799|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD8+ cell population at 6 months. Under the null hypothesis, percent CD8+ cell apoptosis is similar for both treatment groups.||||0.61
71013524|NCT00570492|141533814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|||||TWO_SIDED|95.0|-0.48|-0.06|||||An analysis of covariance (ANCOVA) was performed to estimate the mean treatment difference in growth velocity over the treatment period, adjusting for baseline growth velocity, age, gender, and country.|||-0.06|-0.48|
71013525|NCT05510297|141533845|SUPERIORITY||Median Difference (Net)|7.0||||0.007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.007
71013526|NCT05510297|141533846|SUPERIORITY||Mean Difference (Final Values)|2653.16|STANDARD_DEVIATION|5110.86||0.074|TWO_SIDED|95.0|-297.76522|5604.07522||a priori threshold for statistical significance=0.05 for 2-sided t-test; no adjustments for multiple comparisons made; data were checked for normality using the Shapiro-Wilk test where p\>0.05 was interpreted as likely normal distribution.|t-test, 2 sided|||||5604.07522|-297.76522|0.074
71013527|NCT05510297|141533847|SUPERIORITY|a priori threshold for statistical significance=0.05 for 2-sided t-test; no adjustments for multiple comparisons made;|Mean Difference (Net)|4.44067|STANDARD_DEVIATION|41.59009||0.685|TWO_SIDED|95.0|-18.59116|27.47249|||t-test, 2 sided|||||27.47249|-18.59116|0.685
71013528|NCT05510297|141533848|SUPERIORITY||Mean Difference (Net)|-0.51267|STANDARD_DEVIATION|1.44656||0.191|TWO_SIDED|95.0|-1.31374|0.28841|||t-test, 2 sided|||||0.28841|-1.31374|0.191
71013529|NCT05510297|141533849|SUPERIORITY||Mean Difference (Net)|-0.45|STANDARD_DEVIATION|1.35026||0.218|TWO_SIDED|95.0|-1.19775|0.29775|||t-test, 2 sided|||||0.29775|-1.19775|0.218
71013530|NCT05510297|141533850|SUPERIORITY||Mean Difference (Net)|-0.924|STANDARD_DEVIATION|2.19396||0.125|TWO_SIDED|95.0|-2.13898|0.29098|||t-test, 2 sided|||||0.29098|-2.13898|0.125
71077870|NCT02913105|141664398|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.93||||0.0284|TWO_SIDED|90.0|0.88|0.98|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 28||0.98|0.88|0.0284
71104077|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.82|||||TWO_SIDED|95.0|0.73|4.54||||||At risk subjects||4.54|0.73|
71104078|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.4|||||TWO_SIDED|95.0|1.89|3.05||||||No risk subjects||3.05|1.89|
71013531|NCT05510297|141533851|SUPERIORITY||Mean Difference (Net)|0.00133|STANDARD_DEVIATION|0.10148||0.96|TWO_SIDED|95.0|-0.05486|0.5753|||t-test, 2 sided|||||0.5753|-0.05486|0.960
71104079|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.54|||||TWO_SIDED|95.0|1.29|1.85||||||No risk subjects.||1.85|1.29|
71104080|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.7|||||TWO_SIDED|95.0|1.36|2.11||||||No risk subjects||2.11|1.36|
71013532|NCT05510297|141533855|SUPERIORITY||Mean Difference (Net)|-0.622|STANDARD_DEVIATION|1.6553||0.168|TWO_SIDED|95.0|-1.53867|0.29467|||t-test, 2 sided|||||0.29467|-1.53867|0.168
71013533|NCT04409262|141533861|SUPERIORITY||Hazard Ratio (HR)|0.965||||0.7414|TWO_SIDED|95.0|0.78|1.19|||Log Rank|||||1.19|0.78|0.7414
71013534|NCT04409262|141533862|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.8993|TWO_SIDED|95.0|0.72|1.34|||Log Rank|||||1.34|0.72|0.8993
71047891|NCT04764630|141604896|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.83||||0.002|TWO_SIDED|90.0|0.76|0.91|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (1 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for AUC0-inf will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.91|0.76|0.002
71047892|NCT04764630|141604896|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.75|||<|0.001|TWO_SIDED|90.0|0.7|0.81|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (2 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for AUC0-inf will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.81|0.70|<0.001
71047893|NCT04764630|141604896|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.91||||0.014|TWO_SIDED|90.0|0.85|0.97|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (2 every 2.5 min) (numerator) with the 4 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for AUC0-inf will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.97|0.85|0.014
71047894|NCT04764630|141604897|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.82||||0.001|TWO_SIDED|90.0|0.75|0.89|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (1 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for AUC0-t will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.89|0.75|0.001
71047895|NCT04764630|141604897|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.74|||<|0.001|TWO_SIDED|90.0|0.69|0.8|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (2 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for AUC0-t will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.80|0.69|<0.001
70850378|NCT00947882|141188494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.28||||0.2548|TWO_SIDED|95.0|-11.65|3.096||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 10 mg and Placebo at Month 3."|||3.096|-11.650|0.2548
71013535|NCT04409262|141533863|SUPERIORITY||Odds Ratio (OR)|1.05||||0.7648|TWO_SIDED|95.0|0.77|1.44|||Regression, Logistic|||||1.44|0.77|0.7648
71013536|NCT04409262|141533864|SUPERIORITY||Hazard Ratio (HR)|0.948||||0.7867|TWO_SIDED|95.0|0.65|1.39|||Log Rank|||||1.39|0.65|0.7867
71013537|NCT04409262|141533865|SUPERIORITY||Hazard Ratio (HR)|0.882||||0.4602|TWO_SIDED|95.0|0.63|1.23|||Log Rank|||||1.23|0.63|0.4602
71013538|NCT04409262|141533866|SUPERIORITY||Hazard Ratio (HR)|0.982||||0.8664|TWO_SIDED|95.0|0.8|1.21|||Log Rank|||||1.21|0.80|0.8664
71013539|NCT04409262|141533867|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9569|TWO_SIDED|95.0|0.75|1.35|||Regression, Logistic|||||1.35|0.75|0.9569
71013540|NCT04409262|141533868|SUPERIORITY||Odds Ratio (OR)|1.09||||0.6331|TWO_SIDED|95.0|0.78|1.52|||Regression, Logistic|||||1.52|0.78|0.6331
71013541|NCT04409262|141533869|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9622|TWO_SIDED|95.0|0.7|1.4|||Regression, Logistic|||||1.40|0.70|0.9622
71013542|NCT04409262|141533870|SUPERIORITY||Odds Ratio (OR)|1.14||||0.485|TWO_SIDED|95.0|0.79|1.64|||Regression, Logistic|||||1.64|0.79|0.4850
71013543|NCT04409262|141533871|SUPERIORITY||Weighted % difference|-2.2||||0.5915|TWO_SIDED|95.0|-10.2|5.9|||Cochran-Mantel-Haenszel|||Day 28||5.9|-10.2|0.5915
71013544|NCT04409262|141533871|SUPERIORITY||Weighted % difference|-2.5||||0.5494|TWO_SIDED|95.0|-10.5|5.6|||Cochran-Mantel-Haenszel|||Day 60||5.6|-10.5|0.5494
70928799|NCT04800211|141353093|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-39.501||||0.025|TWO_SIDED|95.0|-75.396|-3.605|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-3.605|-75.396|0.0250
70928800|NCT04800211|141353093|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.94||||0.9997|TWO_SIDED|95.0|-37.896|32.016|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||32.016|-37.896|0.9997
70928801|NCT04800211|141353094|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-54.398||||0.6778|TWO_SIDED|95.0|-177.281|68.485|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||68.485|-177.281|0.6778
70928802|NCT04800211|141353094|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-48.395||||0.7497|TWO_SIDED|95.0|-168.697|71.908|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||71.908|-168.697|0.7497
70928803|NCT04800211|141353095|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-20.01||||0.0003|TWO_SIDED|95.0|-32.447|-7.573|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-7.573|-32.447|0.0003
70928804|NCT04800211|141353095|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-22.566|||<|0.0001|TWO_SIDED|95.0|-34.837|-10.295|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-10.295|-34.837|<.0001
70941447|NCT02418819|141383630|SUPERIORITY_OR_OTHER||LSMean difference from placebo|0.0498|STANDARD_ERROR_OF_MEAN|0.2403||0.4182|ONE_SIDED|99.0|-0.5226||||ANCOVA|One(1)-side P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day 0 assessment.|||-0.5226|0.4182
71013545|NCT04409262|141533872|SUPERIORITY||Weighted % difference|-14.1||||0.259|TWO_SIDED|95.0|-37.4|9.2|||Cochran-Mantel-Haenszel|||Day 28||9.2|-37.4|0.2590
71013546|NCT04409262|141533872|SUPERIORITY||Weighted % difference|-14.6||||0.229|TWO_SIDED|95.0|-37.0|7.8|||Cochran-Mantel-Haenszel|||Day 60||7.8|-37.0|0.2290
71013547|NCT04409262|141533873|SUPERIORITY||Mean Difference (Final Values)|3.1125||||0.2434|TWO_SIDED|95.0|-2.16|8.38|||Regression, Linear|||||8.38|-2.16|0.2434
71013548|NCT04409262|141533874|SUPERIORITY||Weighted % difference|0.6||||0.8222|TWO_SIDED|95.0|-4.4|5.6|||Cochran-Mantel-Haenszel|||Day 14||5.6|-4.4|0.8222
71013549|NCT04409262|141533874|SUPERIORITY||Weighted % difference|-1.3||||0.6944|TWO_SIDED|95.0|-7.8|5.2|||Cochran-Mantel-Haenszel|||Day 28||5.2|-7.8|0.6944
71047896|NCT04764630|141604897|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.91||||0.014|TWO_SIDED|90.0|0.85|0.96|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (2 every 2.5 min) (numerator) with the 4 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for AUC0-t will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.96|0.85|0.014
71077871|NCT02913105|141664398|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.95||||0.133|TWO_SIDED|90.0|0.89|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 42||1.01|0.89|0.1330
71104081|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.12|||||TWO_SIDED|95.0|0.58|7.71||||||At risk subjects.||7.71|0.58|
71104082|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.81|||||TWO_SIDED|95.0|1.61|4.89||||||At risk subjects||4.89|1.61|
71104083|NCT01346592|141715388|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.17|||||TWO_SIDED|95.0|0.37|3.67||||||At risk subjects||3.67|0.37|
71104084|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%|Group difference (H1N1 strain)|9.0|||||TWO_SIDED|95.0|5.4|12.0||||||No risk subjects.||12|5.4|
71104085|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|4.0|||||TWO_SIDED|95.0|1.8|6.6||||||No risk subjects.||6.6|1.8|
70850379|NCT00947882|141188494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.5652|TWO_SIDED|95.0|-9.729|5.322||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 30 mg and Placebo at Month 6."|||5.322|-9.729|0.5652
70850380|NCT00947882|141188494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22||||0.7502|TWO_SIDED|95.0|-8.768|6.322||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 20 mg and Placebo at Month 6."|||6.322|-8.768|0.7502
70850381|NCT00947882|141188494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.97||||0.6089|TWO_SIDED|95.0|-9.513|5.581||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 10 mg and Placebo at Month 6."|||5.581|-9.513|0.6089
70850382|NCT00947882|141188495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.8511|TWO_SIDED|95.0|-1.068|1.294||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 30 mg and Placebo at Month 3."|||1.294|-1.068|0.8511
70850383|NCT00947882|141188495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.6331|TWO_SIDED|95.0|-0.9|1.477||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 20 mg and Placebo at Month 3."|||1.477|-0.900|0.6331
70850384|NCT00947882|141188495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.909|TWO_SIDED|95.0|-1.113|1.25||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 10 mg and Placebo at Month 3."|||1.250|-1.113|0.9090
70850385|NCT00947882|141188495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.5469|TWO_SIDED|95.0|-0.956|1.802||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 30 mg and Placebo at Month 6."|||1.802|-0.956|0.5469
71013550|NCT04409262|141533874|SUPERIORITY||Weighted % difference|-3.0||||0.3919|TWO_SIDED|95.0|-10.1|4.0|||Cochran-Mantel-Haenszel|||Day 60||4.0|-10.1|0.3919
71013551|NCT04409262|141533875|SUPERIORITY||Hazard Ratio (HR)|0.957||||0.6778|TWO_SIDED|95.0|0.78|1.18|||Log Rank|||||1.18|0.78|0.6778
71013552|NCT04409262|141533876|SUPERIORITY||Weighted % difference|-0.9||||0.7692|TWO_SIDED|95.0|-8.7|6.8|||Cochran-Mantel-Haenszel|||||6.8|-8.7|0.7692
71013553|NCT04409262|141533877|SUPERIORITY||Weighted % difference|-0.3||||0.9334|TWO_SIDED|95.0|-7.8|7.2|||Cochran-Mantel-Haenszel|||||7.2|-7.8|0.9334
71013554|NCT01738672|141533889|OTHER|||||||0.16|||||||t-test, 2 sided|||||||0.16
71013555|NCT01738672|141533890|OTHER|||||||0.73|||||||t-test, 2 sided|||||||0.73
71013556|NCT01738672|141533891|OTHER|||||||0.56|||||||t-test, 2 sided|||||||0.56
70941448|NCT00513292|141383644|SUPERIORITY_OR_OTHER||difference in percentages between arms|2.3||||0.7|TWO_SIDED|95.0|-9.3|13.9|||Chi-squared|||The difference in pCR rates between treatment arms for pCR within the Breast, Defined as no Evidence of Invasive Tumor Remaining in the Breast at Surgery Following Completion of Chemotherapy||13.9|-9.3|.7
71013557|NCT00736840|141533901|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Provided above|Sensitivity|0.74|STANDARD_ERROR_OF_MEAN|0.0363||0.0924|TWO_SIDED|95.0|0.6607|0.8809|||Exact binomial test|||The null hypothesis was sensitivity lower than 0.8. We assumed a sensitivity of 0.89 and required a power of 90% to test the hypothesis at a 5% level of significance, and calculated that 173 cirrhotic and 241 non-cirrhotic subjects were needed (for a one-sample binomial test of outcome versus constant).||0.8809|0.6607|0.0924
71013558|NCT00736840|141533902|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sample size was calculated to enable the testing of both study hypotheses (together) with at least 80% power. Our best estimate of sensitivity of the HIS diagnosis in the population, was 0.9 and its specificity 0.79. Requiring a power of 90% for each of the hypotheses and a 5% level of significance, to test the null hypotheses 173 cirrhotic and 241 non-cirrhotic subjects were needed.Therefore a total of at least 414 subjects were required.|AUC ROC|0.785|STANDARD_ERROR_OF_MEAN|0.0485|<|0.0001|TWO_SIDED|95.0|0.737|0.834|||Regression, Logistic|||||0.834|0.737|<0.0001
71013559|NCT03289676|141533905|SUPERIORITY|||||||0.29|||||||Fisher Exact|||||||0.29
71013560|NCT03289676|141533907|OTHER||Odds Ratio, log|1.12||||0.029|TWO_SIDED|95.0|1.0|1.24|||Regression, Logistic|||||1.24|1.00|0.029
71013561|NCT00422227|141533908|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71013562|NCT00422227|141533909|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||ACR 20||||<0.001
71013563|NCT00422227|141533909|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||ACR 50||||<0.001
71013564|NCT00422227|141533909|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Fisher Exact|||ACR 70||||0.009
71013565|NCT00422227|141533910|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||Low Disease (DAS28 \<3.2)||||<0.001
71047897|NCT00899470|141604907|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted condition), then 20 subjects provided 97% power to conclude BE with respect to Cmax of saxagliptin. If 5% difference then 20 subjects provided 93% power to conclude BE with respect to Cmax of saxagliptin.|Geometric Mean Ratio, Test vs. Reference|1.011|||||TWO_SIDED|90.0|0.94|1.088|||Mixed Models Analysis|Bioequivalence=90% confidence intervals (CIs) for the test|For Cmax of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: the geometric mean of the Reference formulation in fasted state|To demonstrate bioequivalence (BE) of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log(Cmax) of saxagliptin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.088|0.940|
71047898|NCT00899470|141604907|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed condition), then 20 subjects provided 97% power to conclude BE with respect to Cmax of saxagliptin. If 5% difference then 20 subjects provided 93% power to conclude BE with respect to Cmax of saxagliptin.|Geometric Mean Ratio, Test vs Reference|0.999|||||TWO_SIDED|90.0|0.929|1.075||||Bioequivalence=90% CIs for the test|For Cmax of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log(Cmax) of saxagliptin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.075|0.929|
71047899|NCT00899470|141604908|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted condition), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin. If 5% difference then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin.|Geometric Mean Ratio, Test vs. Reference|1.029|||||TWO_SIDED|90.0|0.993|1.066|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(0-T) of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: geometric mean of the Reference formulation in fasted state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted and fed states, linear mixed model analysis was performed on log\[AUC(0-T)\] of saxagliptin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.066|0.993|
71047900|NCT00899470|141604908|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed condition), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin. If 5% difference then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin.|Geometric Means Ratio|1.021|||||TWO_SIDED|90.0|0.986|1.058|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(0-T) of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log\[AUC(0-T)\] of saxagliptin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.058|0.986|
71013566|NCT00422227|141533910|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||Fisher Exact|||Remission (DAS28 \<2.6)||||0.069
71013567|NCT00422227|141533911|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
70941449|NCT04341584|141383699|SUPERIORITY||Median posterior HR|0.97|||||TWO_SIDED|90.0|0.62|1.52|||Bayesian Cox model|adjusted for age and centre|% Confidence Interval is % Credible Interval here|||1.52|0.62|
71013568|NCT00422227|141533912|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||||||0.003
71013569|NCT00422227|141533913|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||≥0.6||||0.003
71013570|NCT00422227|141533913|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||≥1.2||||0.001
71013571|NCT00422227|141533914|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||ANCOVA|||Painful Joints at Week 16||||0.014
71013572|NCT00422227|141533914|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Swollen Joints at Week 16||||<0.001
70928805|NCT04800211|141353096|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-179.365|||<|0.0001|TWO_SIDED|95.0|-225.708|-133.022|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-133.022|-225.708|<.0001
70941450|NCT04341584|141383700|SUPERIORITY||Median posterior absolute risk differenc|-2.5|||||TWO_SIDED|90.0|-17.1|12.0|||Bayesian analysis||% Confidence Interval is % Credible Interval here|||12|-17.1|
70941451|NCT04341584|141383701|SUPERIORITY||Median posterior HR|1.26|||||TWO_SIDED|90.0|0.59|2.81||adjusted for age and centre|Bayesian Fine and Gray analysis||% Confidence interval is % Credible Interval here|||2.81|0.59|
71013573|NCT00422227|141533915|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Physician Global Assessment Week 16||||<0.001
71013574|NCT00422227|141533915|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Subject Global Assessment Week 16||||<0.001
71013575|NCT00422227|141533916|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Week 16||||<0.001
71013576|NCT00422227|141533917|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||General Health Week 16||||<0.001
71013577|NCT00422227|141533917|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Pain Week 16||||<0.001
70941452|NCT04341584|141383702|SUPERIORITY||Median posterior absolute risk differenc|24.0|||||TWO_SIDED|90.0|3.9|43.5|||Bayesian analysis||% Confidence interval is % Credible interval here|||43.5|3.9|
70941453|NCT04341584|141383703|SUPERIORITY||Median posterior OR|0.8|||||TWO_SIDED|95.0|0.38|1.68|||Bayesian Proportionnal odds model|Adjusted for age and centre|% Confidence interval is % Credible interval here|Day 4||1.68|0.38|
71013578|NCT00422227|141533917|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||Fatigue Week 16||||0.001
71013579|NCT00157157|141533930|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.95||||||95.0|1.29|19.06||||||||19.06|1.29|
71013580|NCT00157157|141533931|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.18||||||95.0|1.18|14.82||||||||14.82|1.18|
71013581|NCT00157157|141533932|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.5||||||95.0|1.05|19.25||||||||19.25|1.05|
71013582|NCT01018680|141533933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91|||<|0.001||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||Using a 1:1 ratio of allocation to treatment, a 2-tailed 0.05 level of significance and 80% power, 253 participants per arm had been estimated to be adequate to assess an effect size of 0.25, based on a 2-sample Student's t-test. This derived estimate was increased slightly to 261 participants per arm to account for extremely early discontinuation that would have led to exclusion from the efficacy analysis in a small number of participants (approximately 3%).||||<0.001
71013583|NCT01018680|141533934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||<|0.001||95.0||||First gated secondary outcome measure. Gatekeeper strategy (Westfall and Krishen 2001) controlled experiment-wise type I error for 2 secondary outcomes with sequential comparisons of treatments until outcome failed to be significant (p\>0.05).|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71013584|NCT01018680|141533935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.84|||<|0.001||95.0||||WOMAC Physical Disability Score p-value. Second gated secondary outcome measure. Gatekeeper strategy controlled experiment-wise type I error for 2 secondary outcomes with sequential treatment comparisons until outcome failed significance (p\>0.05).|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71013585|NCT01018680|141533935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28|||<|0.001||95.0||||This is the p-value for the WOMAC Pain Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71013586|NCT01018680|141533935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.004||95.0||||This is the p-value for WOMAC Stiffness Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.004
71013587|NCT01018680|141533936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|||<|0.001||95.0||||This is the p-value for Night Pain Intensity. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71077872|NCT02913105|141664398|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.95||||0.2032|TWO_SIDED|90.0|0.89|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 56||1.01|0.89|0.2032
71047901|NCT00899470|141604909|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted condition), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin. If 5% difference then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin.|Geometric Mean Ratio, Test vs. Reference|1.027|||||TWO_SIDED|90.0|0.99|1.066|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(INF) of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: geometric mean of the Reference formulation in fasted state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log\[AUC(INF)\] of saxagliptin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.066|0.990|
70850386|NCT00947882|141188495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.7906|TWO_SIDED|95.0|-1.576|1.2||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 20 mg and Placebo at Month 6."|||1.200|-1.576|0.7906
70850387|NCT00947882|141188495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.5757|TWO_SIDED|95.0|-1.773|0.987||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 10 mg and Placebo at Month 6."|||0.987|-1.773|0.5757
70850388|NCT01708902|141188557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.12||0.0587|TWO_SIDED|95.0|-0.45|0.01|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Metformin 1000mg BID'.|"The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate.~The null and alternative hypotheses were tested in a hierarchical sequence. The next null hypothesis was tested in a confirmatory way only if all prior null-hypotheses were rejected. 'Greater effect' refers to a greater reduction in HbA1c."||0.01|-0.45|0.0587
70850389|NCT01708902|141188557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.23|-0.78|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Linagliptin 5mg QD'.|"The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate.~The null and alternative hypotheses were tested in a hierarchical sequence. The next null hypothesis was tested in a confirmatory way only if all prior null-hypotheses were rejected. 'Greater effect' refers to a greater reduction in HbA1c."||-0.78|-1.23|<0.0001
70850390|NCT01708902|141188557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.73|-0.29|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Metformin 500mg BID'.|"The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate.~The null and alternative hypotheses were tested in a hierarchical sequence. The next null hypothesis was tested in a confirmatory way only if all prior null-hypotheses were rejected. 'Greater effect' refers to a greater reduction in HbA1c."||-0.29|-0.73|<0.0001
70850391|NCT01708902|141188557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.09|-0.64|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Linagliptin 5mg QD'.|"The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate.~The null and alternative hypotheses were tested in a hierarchical sequence. The next null hypothesis was tested in a confirmatory way only if all prior null-hypotheses were rejected. 'Greater effect' refers to a greater reduction in HbA1c."||-0.64|-1.09|<0.0001
70850392|NCT01708902|141188558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.673|STANDARD_ERROR_OF_MEAN|0.487||0.0771|TWO_SIDED|95.0|0.946|2.961|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Metformin 1000mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."||2.961|0.946|0.0771
70850393|NCT01708902|141188558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.489|STANDARD_ERROR_OF_MEAN|1.543|<|0.0001|TWO_SIDED|95.0|3.164|9.522|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||9.522|3.164|<0.0001
70850394|NCT01708902|141188558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.829|STANDARD_ERROR_OF_MEAN|0.753|<|0.0001|TWO_SIDED|95.0|1.678|4.767|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Metformin 500mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."||4.767|1.678|<0.0001
70850395|NCT01708902|141188558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.818|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|95.0|2.259|6.454|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||6.454|2.259|<0.0001
70850396|NCT01708902|141188559|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.169|STANDARD_ERROR_OF_MEAN|1.565||0.0001|TWO_SIDED|95.0|1.997|8.701|||Regression, Logistic|||"Comparison of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' / 'APG: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||8.701|1.997|0.0001
70850397|NCT01708902|141188560|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.661|STANDARD_ERROR_OF_MEAN|0.426||0.048|TWO_SIDED|95.0|1.004|2.746|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Metformin 1000mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."||2.746|1.004|0.0480
70850398|NCT01708902|141188560|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.923|STANDARD_ERROR_OF_MEAN|1.632|<|0.0001|TWO_SIDED|95.0|3.452|10.164|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||10.164|3.452|<0.0001
70850399|NCT01708902|141188560|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.574|STANDARD_ERROR_OF_MEAN|0.655||0.0002|TWO_SIDED|95.0|1.563|4.239|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Metformin 500mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."||4.239|1.563|0.0002
70941454|NCT04341584|141383703|SUPERIORITY||Median posterior OR|0.69|||||TWO_SIDED|95.0|0.33|1.43|||Bayesian Proportionnal odds model|Adjusted for age and centre|% Confidence interval is % Credible interval here|Day 14||1.43|0.33|
70850400|NCT01708902|141188560|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.682|STANDARD_ERROR_OF_MEAN|1.27|<|0.0001|TWO_SIDED|95.0|2.751|7.968|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||7.968|2.751|<0.0001
70850401|NCT01708902|141188561|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.135|STANDARD_ERROR_OF_MEAN|1.31||0.0062|TWO_SIDED|95.0|1.383|7.11|||Regression, Logistic|||"Comparison of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' / 'APG: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||7.110|1.383|0.0062
70850402|NCT01708902|141188562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0109|TWO_SIDED|95.0|-0.53|-0.07|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Metformin 1000mg BID'.|"Sensitivity analysis: Mixed Model for repeated measurements~The model includes baseline HbA1c as a linear covariate; visit, treatment and visit by treatment interaction as fixed classification effects and patient as a random effect with unstructured covariance structure to model within-patients errors."||-0.07|-0.53|0.0109
70850403|NCT01708902|141188562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.27|-0.81|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Linagliptin 5mg QD'.|"Sensitivity analysis: Mixed Model for repeated measurements~The model includes baseline HbA1c as a linear covariate; visit, treatment and visit by treatment interaction as fixed classification effects and patient as a random effect with unstructured covariance structure to model within-patients errors."||-0.81|-1.27|<0.0001
70850404|NCT01708902|141188562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.7|-0.24|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID ' minus 'Main: Metformin 500mg BID' .|"Sensitivity analysis: Mixed Model for repeated measurements~The model includes baseline HbA1c as a linear covariate; visit, treatment and visit by treatment interaction as fixed classification effects and patient as a random effect with unstructured covariance structure to model within-patients errors."||-0.24|-0.70|<0.0001
70850405|NCT01708902|141188562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.04|-0.58|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Linagliptin 5mg QD'.|"Sensitivity analysis: Mixed Model for repeated measurements~The model includes baseline HbA1c as a linear covariate; visit, treatment and visit by treatment interaction as fixed classification effects and patient as a random effect with unstructured covariance structure to model within-patients errors."||-0.58|-1.04|<0.0001
70850406|NCT01708902|141188563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.32||0.0001|TWO_SIDED|95.0|-1.87|-0.63|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'APG: Linagliptin 5mg QD'.|"The treatment effect of the 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' was compared with 'APG: Linagliptin 5mg QD'.~The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate."||-0.63|-1.87|0.0001
70850407|NCT01708902|141188564|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.986|STANDARD_ERROR_OF_MEAN|0.387||0.9705|TWO_SIDED|95.0|0.456|2.13|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Metformin 1000mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."||2.130|0.456|0.9705
70850408|NCT01708902|141188564|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.093|STANDARD_ERROR_OF_MEAN|1.029||0.0007|TWO_SIDED|95.0|1.612|5.938|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||5.938|1.612|0.0007
70850409|NCT01708902|141188564|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.19|STANDARD_ERROR_OF_MEAN|1.243||0.0029|TWO_SIDED|95.0|1.486|6.849|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Metformin 500mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."||6.849|1.486|0.0029
70850410|NCT01708902|141188564|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.871|STANDARD_ERROR_OF_MEAN|1.846|<|0.0001|TWO_SIDED|95.0|2.318|10.238|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||10.238|2.318|<0.0001
70850411|NCT01708902|141188565|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.865|STANDARD_ERROR_OF_MEAN|1.015||0.2523|TWO_SIDED|95.0|0.642|5.42|||Regression, Logistic|||"Comparison of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' / 'APG: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||5.420|0.642|0.2523
70850412|NCT01708902|141188566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.37|STANDARD_ERROR_OF_MEAN|3.23||0.0971|TWO_SIDED|95.0|-11.72|0.98|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Metformin 1000mg BID'.|The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.||0.98|-11.72|0.0971
70850413|NCT01708902|141188566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.42|STANDARD_ERROR_OF_MEAN|3.19|<|0.0001|TWO_SIDED|95.0|-38.67|-26.16|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Linagliptin 5mg QD'.|The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.||-26.16|-38.67|<0.0001
70850414|NCT01708902|141188566|SUPERIORITY_OR_OTHER||Median Difference (Net)|-9.47|STANDARD_ERROR_OF_MEAN|3.16||0.0028|TWO_SIDED|95.0|-15.66|-3.27|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Metformin 500mg BID'.|The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.||-3.27|-15.66|0.0028
70941455|NCT04341584|141383703|SUPERIORITY||Median posterior OR|0.7|||||TWO_SIDED|95.0|0.35|1.38|||Bayesian Proportionnal odds model|Adjusted for age and centre|% Confidence interval is % Credible interval here|Day 28||1.38|0.35|
71013588|NCT01018680|141533936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03|||<|0.001||95.0||||This is the p-value for Worst Pain Intensity. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71013589|NCT01018680|141533937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|||<|0.001||95.0||||This is the p-value for BPI-S for Worst Pain. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71013590|NCT01018680|141533937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.001||95.0||||This is the p-value for BPI-S for Least Pain. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71013591|NCT01018680|141533937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|||<|0.001||95.0||||This is the p-value for BPI-S for Average Pain. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71013592|NCT01018680|141533937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|||<|0.001||95.0||||This is the p-value for BPI-S for Pain Right Now. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71013593|NCT01018680|141533937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|||<|0.001||95.0||||This is the p-value for BPI-I for General Activity. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71013594|NCT01018680|141533937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|||<|0.001||95.0||||This is the p-value for BPI-I for Mood. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71013595|NCT01018680|141533937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|||<|0.001||95.0||||This is the p-value for BPI-I for Walking Ability. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71013596|NCT01018680|141533937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|||<|0.001||95.0||||This is the p-value for BPI-I for Normal Work. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71013597|NCT01018680|141533937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|||<|0.001||95.0||||This is the p-value for BPI-I for Relations with Others. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71077873|NCT02913105|141664398|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.1141|TWO_SIDED|90.0|0.87|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 84||1.00|0.87|0.1141
71013598|NCT01018680|141533937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|||<|0.001||95.0||||This is the p-value for BPI-I for Sleep. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71013599|NCT01018680|141533937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|||<|0.001||95.0||||This is the p-value for BPI-I for Enjoyment of Life. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71013600|NCT01018680|141533937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|||<|0.001||95.0||||This is the p-value for BPI-I for Mean Interference Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71013601|NCT01018680|141533938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|||<|0.001||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71013602|NCT01018680|141533939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17|||<|0.001||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71013603|NCT01018680|141533940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.449||95.0||||This is the p-value for the BPOMS Total Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.449
71013604|NCT01018680|141533940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.265||95.0||||This is the p-value for the BPOMS Tension-Anxiety Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.265
71013605|NCT01018680|141533940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.18||95.0||||This is the p-value for the BPOMS Depression-Dejection Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.180
70941456|NCT04341584|141383703|SUPERIORITY||Median posterior OR|0.72|||||TWO_SIDED|95.0|0.22|2.39|||Bayesian Proportionnal odds model|Adjusted for age and centre|% Confidence Interval is % Credible interval here|Day 4||2.39|0.22|
71047902|NCT00899470|141604909|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed condition), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin. If 5% difference then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin.|Geometric Means Ratio Test vs. Reference|1.022|||||TWO_SIDED|95.0|0.985|1.06|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(INF) of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log\[AUC(INF)\] of saxagliptin and metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.060|0.985|
71047903|NCT00899470|141604911|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted and fed), then 20 subjects provided 98% power to conclude BE with respect to Cmax of metformin. If 5% difference then 20 subjects provided 93% power to conclude BE with respect to Cmax of metformin, respectively.|Geometric Mean Ratio, Test vs. Reference|1.009|||||TWO_SIDED|90.0|0.939|1.084|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For Cmax of metformin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: geometric mean of the Reference formulation in fasted fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log(Cmax) of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.084|0.939|
71047904|NCT00899470|141604911|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed), then 20 subjects provided 98% power to conclude BE with respect to Cmax of metformin. If 5% difference then 20 subjects provided 93% power to conclude BE with respect to Cmax of metformin.|Geometric Mean Ratio, Test vs. Reference|1.034|||||TWO_SIDED|90.0|0.962|1.111|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For Cmax of metformin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log(Cmax) of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.111|0.962|
71077874|NCT02913105|141664398|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.1342|TWO_SIDED|90.0|0.88|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 112 (EOS)||1.01|0.88|0.1342
71104086|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|12.0|||||TWO_SIDED|95.0|9.2|14.8||||||No risk subjects.||14.8|9.2|
71104087|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-1.0|||||TWO_SIDED|95.0|-24.0|18.7||||||At risk subjects.||18.7|-24|
70928806|NCT04800211|141353096|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-153.22|||<|0.0001|TWO_SIDED|95.0|-198.93|-107.509|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-107.509|-198.930|<.0001
70941457|NCT04341584|141383703|SUPERIORITY||Median posterior HR|0.89|||||TWO_SIDED|95.0|0.28|2.8|||Bayesian Proportionnal odds model|Adjusted for age and centre|% Confidence Interval is % Credible interval here|Day 7||2.80|0.28|
71104088|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|1.0|||||TWO_SIDED|95.0|-21.2|18.9||||||At risk subjects.||18.9|-21.2|
71104089|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|14.0|||||TWO_SIDED|95.0|-1.6|29.5||||||At risk subjects.||29.5|-1.6|
71104090|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|14.0|||||TWO_SIDED|95.0|10.7|17.7||||||No risk subjects.||17.7|10.7|
71104091|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|7.0|||||TWO_SIDED|95.0|4.6|9.8||||||No risk subjects.||9.8|4.6|
70941458|NCT04341584|141383703|SUPERIORITY||Median posterior HR|0.57|||||TWO_SIDED|95.0|0.18|1.75||Day 14|Bayesian Proportionnal odds model|Adjusted for afe and centre|% Confidence Interval is % Credible interval here|||1.75|0.18|
71104092|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|13.0|||||TWO_SIDED|95.0|10.7|16.4||||||No risk subjects||16.4|10.7|
71104093|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-3.0|||||TWO_SIDED|95.0|-26.1|19.2||||||At risk subjects.||19.2|-26.1|
71013606|NCT01018680|141533940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.041||95.0||||This is the p-value for the BPOMS Anger-Hostility Score. 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.041
71013607|NCT01018680|141533940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.356||95.0||||This is the p-value for the BPOMS Vigor-Activity Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.356
71047905|NCT00899470|141604912|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of metformin. If 5% difference then 20 subjects provided 95% power to conclude BE with respect to AUC(INF) of metformin.|Geometric Mean Ratio, Test vs. Reference|1.024|||||TWO_SIDED|90.0|0.964|1.088|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(0-T) of metformin the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: geometric mean of the Reference formulation in fasted state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log\[AUC(0-T)\] of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.088|0.964|
71047906|NCT00899470|141604912|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of metformin. If 5% difference then 20 subjects provided 95% power to conclude BE with respect to AUC(INF) of metformin.|Geometric Mean Ratio, Test vs. Reference|1.042|||||TWO_SIDED|90.0|0.981|1.108|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(0-T) of metformin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log\[AUC(0-T)\] of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.108|0.981|
71047907|NCT00899470|141604913|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted ), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of metformin. If 5% difference then 20 subjects provided 95% power to conclude BE with respect to AUC(INF) of metformin.|Geometric Mean Ratio, Test vs. Reference|1.029|||||TWO_SIDED|90.0|0.973|1.088|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(INF) of metformin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: the geometric mean of the Reference formulation in fasted state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log\[AUC(INF)\] of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.088|0.973|
71047908|NCT00899470|141604913|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of metformin. If 5% difference then 20 subjects provided 95% power to conclude BE with respect to AUC(INF) of metformin.|Geometric Mean Ratio, Test vs. Reference|1.042|||||TWO_SIDED|90.0|0.986|1.102|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(INF) of metformin, the point estimate and 90% confidence interval (CI) were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log\[AUC(INF)\] of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.102|0.986|
71047909|NCT01366443|141604926|SUPERIORITY_OR_OTHER||Sensitivity|0.85|||||TWO_SIDED|95.0|0.79|0.89|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Sensitivity = true positives/(true positives + false negatives); It indicates how likely is the test to detect the presence of a characteristic in someone with the characteristic.||0.89|0.79|
71047910|NCT01366443|141604926|SUPERIORITY_OR_OTHER||Specificity|0.98|||||TWO_SIDED|95.0|0.93|0.99|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Specificity = true negatives/(false positives + true negatives); It indicates how likely the test is to detect the absence of a characteristic in someone without the characteristic.||0.99|0.93|
71013608|NCT01018680|141533940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.862||95.0||||This is the p-value for the BPOMS Fatigue-Inertia Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.862
71013609|NCT01018680|141533940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.883||95.0||||This is the p-value for the BPOMS Confusion-Bewilderment Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.883
71013610|NCT01018680|141533941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.083||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.083
71013611|NCT01018680|141533942|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||<0.001
71013612|NCT01018680|141533943|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 30% Response (LOCF) based on 24-Hour Average Pain Ratings. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||<0.001
71013613|NCT01018680|141533943|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 50% Response (LOCF) based on 24-Hour Average Pain Ratings. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||<0.001
71047911|NCT01366443|141604926|SUPERIORITY_OR_OTHER||Positive Predictive Value|0.99|||||TWO_SIDED|95.0|0.96|1.0|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Positive Predictive Value = true positives/(true positives + false positives); It indicates how likely it is that someone with a positive test result will actually have the characteristic.||1.00|0.96|
71047912|NCT01366443|141604926|SUPERIORITY_OR_OTHER||Negative Predictive Value|0.77|||||TWO_SIDED|95.0|0.69|0.84|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Negative Predictive Value = true negatives/(true negatives + false negatives); It indicates how likely it is that someone with a negative test result will actually not have the characteristic.||0.84|0.69|
71047913|NCT01366443|141604926|SUPERIORITY_OR_OTHER||Sensitivity|0.99|||||TWO_SIDED|95.0|0.97|1.0|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Sensitivity = true positives/(true positives + false negatives); It indicates how likely is the test to detect the presence of a characteristic in someone with the characteristic.||1.00|0.97|
71047914|NCT01366443|141604926|SUPERIORITY_OR_OTHER||Specificity|0.91|||||TWO_SIDED|95.0|0.83|0.95|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Specificity = true negatives/(false positives + true negatives); It indicates how likely the test is to detect the absence of a characteristic in someone without the characteristic.||0.95|0.83|
71047915|NCT01366443|141604926|SUPERIORITY_OR_OTHER||Positive Predictive Value|0.95|||||TWO_SIDED|95.0|0.9|0.98|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Positive Predictive Value = true positives/(true positives + false positives); It indicates how likely it is that someone with a positive test result will actually have the characteristic.||0.98|0.90|
71047916|NCT01366443|141604926|SUPERIORITY_OR_OTHER||Negative Predictive Value|0.99|||||TWO_SIDED|95.0|0.94|1.0|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Negative Predictive Value = true negatives/(true negatives + false negatives); It indicates how likely it is that someone with a negative test result will actually not have the characteristic.||1.00|0.94|
71047917|NCT00369382|141604927|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||two-sided alpha = 0.05|ANCOVA|Analysis of covariance (ANCOVA) with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 52||||0.004
71013614|NCT01018680|141533944|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 30% Response (LOCF) based on BPI Average Pain Ratings.|Fisher Exact|||||||<0.001
71013615|NCT01018680|141533944|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 50% Response (LOCF) based on BPI Average Pain Ratings.|Fisher Exact|||||||<0.001
71013616|NCT01018680|141533945|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.012
71013617|NCT01018680|141533946|SUPERIORITY_OR_OTHER|||||||0.724||95.0||||This is the p-value for PCS Weight Gain. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.724
71047918|NCT00369382|141604929|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 4||||0.018
71104094|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|6.0|||||TWO_SIDED|95.0|-17.5|27.3||||||At risk subjects.||27.3|-17.5|
71104095|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|12.0|||||TWO_SIDED|95.0|-4.4|29.2||||||At risk subjects.||29.2|-4.4|
71104096|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|11.0|||||TWO_SIDED|95.0|7.2|14.5||||||No risk subjects.||14.5|7.2|
71104097|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|5.0|||||TWO_SIDED|95.0|2.6|7.5||||||No risk subjects.||7.5|2.6|
71013618|NCT01018680|141533946|SUPERIORITY_OR_OTHER|||||||0.106||95.0||||This is the p-value for PCS Weight Loss. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.106
71013619|NCT01018680|141533947|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.031
71013620|NCT01018680|141533948|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||This is the p-value for Diastolic Hypertension. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.063
71013621|NCT01018680|141533948|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||This is the p-value for Systolic Hypertension. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.018
70928807|NCT04800211|141353097|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.569|||<|0.0001|TWO_SIDED|95.0|-3.084|-2.054|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-2.054|-3.084|<.0001
70928808|NCT04800211|141353097|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.586|||<|0.0001|TWO_SIDED|95.0|-3.092|-2.081|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-2.081|-3.092|<.0001
71013622|NCT01018680|141533949|SUPERIORITY_OR_OTHER|||||||0.249||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.249
70928809|NCT04800211|141353099|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.42||||0.0839|TWO_SIDED|95.0|-0.19|3.04|||ANCOVA||The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||3.04|-0.19|0.0839
70928810|NCT04800211|141353099|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|2.1||||0.0089|TWO_SIDED|95.0|0.53|3.66|||ANCOVA||The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||3.66|0.53|0.0089
70928811|NCT04800211|141353100|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.26||||0.7101|TWO_SIDED|95.0|-1.13|1.66|||ANCOVA||The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||1.66|-1.13|0.7101
70941459|NCT04341584|141383704|SUPERIORITY||Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.23|1.29|||Regression, Cox|adjusted for age and centre||14 days||1.29|0.23|
70941460|NCT04341584|141383704|SUPERIORITY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.33|1.77|||Regression, Cox|Adjusted for age and centre||28 days||1.77|0.33|
71104098|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|13.0|||||TWO_SIDED|95.0|9.5|15.8||||||No risk subjects.||15.8|9.5|
71013623|NCT01018680|141533950|SUPERIORITY_OR_OTHER|||||||0.241||95.0||||This is the p-value for outpatient group visits. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.241
71013624|NCT01018680|141533950|SUPERIORITY_OR_OTHER|||||||0.087||95.0||||This is the p-value for outpatient individual visits. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.087
71013625|NCT01018680|141533950|SUPERIORITY_OR_OTHER|||||||0.414||95.0||||This is the p-value for emergency room visits for non-psychiatric illness. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.414
71013626|NCT01018680|141533950|SUPERIORITY_OR_OTHER|||||||0.332||95.0||||This is the p-value for outpatient visits to other physicians. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.332
71104099|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|5.0|||||TWO_SIDED|95.0|-24.7|26.3||||||At risk subjects.||26.3|-24.7|
71104100|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|5.0|||||TWO_SIDED|95.0|-26.9|30.3||||||At risk subjects.||30.3|-26.9|
71104101|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|9.0|||||TWO_SIDED|95.0|-16.9|27.1||||||At risk subjects.||27.1|-16.9|
70928812|NCT04800211|141353100|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.24||||0.7325|TWO_SIDED|95.0|-1.12|1.59|||ANCOVA||The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||1.59|-1.12|0.7325
70928813|NCT04800211|141353101|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.48||||0.0136|TWO_SIDED|95.0|0.31|2.66|||ANCOVA||The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||2.66|0.31|0.0136
70928814|NCT04800211|141353101|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.94||||0.0009|TWO_SIDED|95.0|0.8|3.08|||ANCOVA||The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||3.08|0.80|0.0009
70941461|NCT04341584|141383704|SUPERIORITY|90 days|Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.46|2.04|||Regression, Cox|adjusted on age and centre|% Confidence interval is % Credible interval here|||2.04|0.46|
71013627|NCT01018680|141533950|SUPERIORITY_OR_OTHER|||||||0.183||95.0||||This is the p-value for the average number of hours worked for pay per week. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.183
71013628|NCT01018680|141533950|SUPERIORITY_OR_OTHER|||||||0.666||95.0||||This is the p-value for how long the participant has had this job. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.666
71013629|NCT01018680|141533950|SUPERIORITY_OR_OTHER|||||||0.89||95.0||||This is the p-value for the average number of hours of volunteer work per week. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.890
71013630|NCT01018680|141533950|SUPERIORITY_OR_OTHER|||||||0.413||95.0||||This is the p-value for psychiatric visits. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.413
71047919|NCT00369382|141604929|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 16||||<.001
71104102|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|16.0|||||TWO_SIDED|95.0|12.4|20.2||||||No risk subjects.||20.2|12.4|
71013631|NCT02383966|141533954|OTHER||Hazard Ratio (HR)|0.566|||||TWO_SIDED|95.0|0.4|0.803||||||||0.803|0.400|
71013632|NCT02383966|141533955|OTHER||Hazard Ratio (HR)|0.568|||||TWO_SIDED|95.0|0.406|0.795||||||||0.795|0.406|
71013633|NCT02383966|141533956|OTHER||Hazard Ratio (HR)|0.705|||||TWO_SIDED|95.0|0.502|0.991||||||||0.991|0.502|
71013634|NCT02383966|141533957|OTHER||Odds Ratio (OR)|2.76|||||TWO_SIDED|95.0|1.52|5.45||||||||5.45|1.52|
71013635|NCT02383966|141533958|OTHER||Odds Ratio (OR)|2.14|||||TWO_SIDED|95.0|1.15|3.95||||||||3.95|1.15|
71013636|NCT02163759|141533961|SUPERIORITY||Difference in Remission Rates|12.3||||0.0173|TWO_SIDED|95.0|1.59|20.6||The threshold for statistical significance was a p-value \<0.05.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|The null hypothesis (H0): the percentage of participants achieving remission at Week 10 was the same in both the placebo and etrolizumab arms. The alternative hypothesis (H1): the percentage of participants achieving remission at Week 10 was not the same in the placebo and etrolizumab arms.||20.60|1.59|0.0173
71047920|NCT00369382|141604929|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 24||||0.012
71047921|NCT00369382|141604929|SUPERIORITY_OR_OTHER|||||||0.072|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 32||||0.072
71047922|NCT00369382|141604929|SUPERIORITY_OR_OTHER|||||||0.175|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 40||||0.175
71047923|NCT00369382|141604930|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 4||||0.031
71047924|NCT00369382|141604930|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 16||||<0.001
71047925|NCT00369382|141604930|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 24||||0.020
71013637|NCT02163759|141533962|SUPERIORITY||Difference in Remission Rates|-3.1||||0.5055|TWO_SIDED|95.0|-12.61|6.37||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||6.37|-12.61|0.5055
71013638|NCT02163759|141533963|SUPERIORITY||Difference in Remission Rates|-5.0||||1|TWO_SIDED|95.0|-11.66|1.75||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 3 of the testing procedure; please refer to the statistical analysis plan for details.||1.75|-11.66|1
71013639|NCT02163759|141533964|SUPERIORITY||Difference in Response Rates|6.9||||0.4434|TWO_SIDED|95.0|-7.03|20.62||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 1 of the testing procedure; please refer to the statistical analysis plan for details.||20.62|-7.03|0.4434
71013640|NCT02163759|141533964|SUPERIORITY||Difference in Response Rates|4.8||||0.4122|TWO_SIDED|95.0|-6.72|16.07||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||16.07|-6.72|0.4122
71013641|NCT02163759|141533965|SUPERIORITY||Difference in Response Rates|1.2||||1|TWO_SIDED|95.0|-6.98|9.26||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 3 of the testing procedure; please refer to the statistical analysis plan for details.||9.26|-6.98|1
71029130|NCT04885296|141565769|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the mean difference (Test - Control) was greater than -5. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for population of soft disposable contact lens wearers.|LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.62|||TWO_SIDED|95.0|-4.0|2.3|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test - Control|||2.3|-4.0|
71029131|NCT04885296|141565770|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the mean difference (Test - Control) was greater than -5. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for population of soft disposable contact lens wearers.|LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|1.61|||TWO_SIDED|95.0|-4.7|1.7|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test - Control|||1.7|-4.7|
71029132|NCT01027143|141565777|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
71029133|NCT02564263|141565785|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.00894|TWO_SIDED|95.0|0.63|0.96||One-sided p-value based on stratified log-rank test|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW)|||0.96|0.63|0.00894
71029134|NCT02564263|141565786|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.00855|TWO_SIDED|95.0|0.52|0.94||One-sided p-value based on stratified log-rank test|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW) \& tumor histology (SCC vs adenocarcinoma/Siewert type 1 adenocarcinoma of the esophagogastric junction \[EGJ\])|||0.94|0.52|0.00855
71047926|NCT00369382|141604930|SUPERIORITY_OR_OTHER|||||||0.151|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 32||||0.151
71047927|NCT00369382|141604930|SUPERIORITY_OR_OTHER|||||||0.295|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 40||||0.295
71047928|NCT00369382|141604930|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 52||||0.010
71029135|NCT02564263|141565787|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.0531|TWO_SIDED|95.0|0.75|1.05||One-sided p-value based on stratified maximum weighted log rank test: the maximum of the log-rank test statistic \& a weighted log-rank Fleming-Harrington (0,1) test statistic|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW) \& tumor histology (SCC vs adenocarcinoma/Siewert type 1 adenocarcinoma of the esophagogastric junction \[EGJ\])|||1.05|0.75|0.0531
71047929|NCT00369382|141604932|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 4||||0.009
71047930|NCT00369382|141604932|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 16||||<0.001
71013642|NCT02163759|141533966|SUPERIORITY||Difference in Response Rates|17.9||||0.0173|TWO_SIDED|95.0|4.49|29.5||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 1 of the testing procedure; please refer to the statistical analysis plan for details.||29.50|4.49|0.0173
71013643|NCT02163759|141533966|SUPERIORITY||Difference in Response Rates|7.4||||0.1886|TWO_SIDED|95.0|-3.77|18.32||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||18.32|-3.77|0.1886
71013644|NCT02163759|141533967|SUPERIORITY||Difference in Response Rates|1.9||||1|TWO_SIDED|95.0|-6.04|9.88||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 3 of the testing procedure; please refer to the statistical analysis plan for details.||9.88|-6.04|1
71013645|NCT02163759|141533968|SUPERIORITY||Difference in Remission Rates|13.8||||0.1347|TWO_SIDED|95.0|2.97|22.15||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||22.15|2.97|0.1347
71029136|NCT02564263|141565788|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.287|TWO_SIDED|95.0|0.94|1.31||One-sided p-value based on stratified maximum weighted log rank test: the maximum of the log-rank test statistic \& a weighted log-rank Fleming-Harrington (0,1) test statistic|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW) \& tumor histology (SCC vs adenocarcinoma/Siewert type 1 adenocarcinoma of the EGJ)|||1.31|0.94|0.287
71029137|NCT02564263|141565789|SUPERIORITY||Difference in Percentages|6.4||||0.0037|TWO_SIDED|95.0|1.7|11.2||One-sided p-value for testing. H0: difference in %=0 versus; H1: difference in %\>0.|Miettinen & Nurminen method||Miettinen \& Nurminen method stratified by geographic region (Asia vs RoW) \& tumor histology (SCC vs adenocarcinoma/Siewert type I adenocarcinoma of the EGJ)|||11.2|1.7|0.0037
71029138|NCT02564263|141565790|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.216|TWO_SIDED|95.0|0.75|1.13||One-sided p-value based on stratified log-rank test|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW)|||1.13|0.75|0.216
71029139|NCT02564263|141565791|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.015|TWO_SIDED|95.0|0.54|0.97||One-sided p-value based on stratified log-rank test|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW) \& tumor histology (SCC vs adenocarcinoma/Siewert type 1 adenocarcinoma of the EGJ)|||0.97|0.54|0.015
71104103|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|8.0|||||TWO_SIDED|95.0|5.1|10.5||||||No risk subjects||10.5|5.1|
71104104|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|15.0|||||TWO_SIDED|95.0|12.0|18.6||||||No risk subjects||18.6|12|
71104105|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|2.0|||||TWO_SIDED|95.0|-27.1|25.5||||||At risk subjects||25.5|-27.1|
71104106|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|10.0|||||TWO_SIDED|95.0|-23.5|37.2||||||At risk subjects||37.2|-23.5|
71104107|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|16.0|||||TWO_SIDED|95.0|-10.7|38.0||||||At risk subjects.||38|-10.7|
71029140|NCT02564263|141565792|SUPERIORITY||Difference in Percentages|9.2||||0.0022|TWO_SIDED|95.0|3.0|15.8||One-sided p-value for testing. H0: difference in %=0; H1: difference in %\>0.|Miettinen & Nurminen method||Miettinen \& Nurminen method stratified by geographic region (Asia vs RoW)|||15.8|3.0|0.0022
71029141|NCT02564263|141565793|SUPERIORITY||Difference in Percentages|15.1||||0.0006|TWO_SIDED|95.0|6.2|24.7||One-sided p-value for testing. H0: difference in %=0; H1: difference in %\>0.|Miettinen & Nurminen method||Miettinen \& Nurminen method stratified by geographic region (Asia vs RoW) \& tumor histology (SCC vs adenocarcinoma/Siewert type I adenocarcinoma of the EGJ)|||24.7|6.2|0.0006
71029142|NCT02252562|141565796|EQUIVALENCE|We hypothesized a potential 66% reduction from a baseline incidence of 0.16 on the basis of prior interventions, but we assumed for power considerations a more conservative reduction of 40% from a baseline incidence of 0.12 averaged across all patients in each arm. Assuming a 10% loss to follow-up, we required 1,600 patients per group for a power of 0.9 with a type 1 error of .05.|Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.82|1.4|||fixed effects univariable analysis|||||1.40|0.82|
71029143|NCT00486837|141565839|SUPERIORITY_OR_OTHER|||||||0.197||95.0|||||ANCOVA|||||||0.197
71029144|NCT00262964|141565868|SUPERIORITY_OR_OTHER||||||<|0.019||95.0|||||t-test, 2 sided|||null hypothesis was no difference in hepatic insulin sensitivity between normal and high IHTG subjects||||<0.019
71013646|NCT02163759|141533968|SUPERIORITY||Difference in Remission Rates|0.5||||0.9138|TWO_SIDED|95.0|-8.95|9.92||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||9.92|-8.95|0.9138
70928815|NCT04800211|141353102|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|0.038||||0.9294|TWO_SIDED|95.0|-0.795|0.87|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||0.870|-0.795|0.9294
70941462|NCT04341584|141383704|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.11|3.86|||Regression, Cox|adjusted on age and centre||||3.86|0.11|
71013647|NCT02163759|141533969|SUPERIORITY||Difference in Remission Rates|-3.5||||1|TWO_SIDED|95.0|-10.27|3.3||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||3.30|-10.27|1
71013648|NCT02163759|141533970|SUPERIORITY||Difference in Remission Rates|26.3||||0.0173|TWO_SIDED|95.0|12.1|37.86||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||37.86|12.10|0.0173
71013649|NCT02163759|141533970|SUPERIORITY||Difference in Remission Rates|13.2||||0.0313|TWO_SIDED|95.0|0.93|24.94||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||24.94|0.93|0.0313
71013650|NCT02163759|141533971|SUPERIORITY||Difference in Remission Rates|-0.3||||1|TWO_SIDED|95.0|-9.13|8.45||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||8.45|-9.13|1
71013651|NCT02163759|141533972|SUPERIORITY|||||||0.4434||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and RB score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||||0.4434
71013652|NCT02163759|141533972|SUPERIORITY|||||||0.3374||||||Nominal p-value; it has not been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and RB score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||||0.3374
71013653|NCT02163759|141533973|SUPERIORITY|||||||1||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and RB score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||||1
71029145|NCT00262964|141565869|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||a priori threshold for significance was P\<0.05.|t-test, 2 sided|||null hypothesis was that VLDL-TG production would not differ between the two groups.||||<0.001
70941463|NCT04341584|141383704|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.19|4.68|||Regression, Cox|adjusted on age and centre||||4.68|0.19|
71104108|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|2.0|||||TWO_SIDED|95.0|-4.2|10.4||||||No risk subjects.||10.4|-4.2|
71104109|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 subjects)|4.0|||||TWO_SIDED|95.0|-1.2|11.9||||||No risk subjects.||11.9|-1.2|
71104110|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|8.0|||||TWO_SIDED|95.0|2.9|15.1||||||No risk subjects.||15.1|2.9|
71104111|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-5.0|||||TWO_SIDED|95.0|-42.4|32.0||||||At risk subjects.||32|-42.4|
70928816|NCT04800211|141353102|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.277||||0.529|TWO_SIDED|95.0|-0.587|1.142|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||1.142|-0.587|0.5290
70928817|NCT04800211|141353102|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-0.508||||0.2291|TWO_SIDED|95.0|-1.337|0.321|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||0.321|-1.337|0.2291
70928818|NCT04800211|141353102|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.525||||0.2179|TWO_SIDED|95.0|-0.311|1.361|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||1.361|-0.311|0.2179
71013654|NCT02163759|141533974|SUPERIORITY|||||||0.4434||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and SF score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||||0.4434
71013655|NCT02163759|141533974|SUPERIORITY|||||||0.6367||||||Nominal p-value; it has not been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and SF score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||||0.6367
71013656|NCT02163759|141533975|SUPERIORITY|||||||1||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and SF score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||||1
71029146|NCT00262964|141565870|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||a priori threshold for significance was set at p = 0.05.|t-test, 2 sided|||null hypothesis was no difference in skeletal muscle insulin sensitivity between groups.||||<0.001
71029147|NCT00262964|141565871|SUPERIORITY_OR_OTHER||||||<|0.002||95.0|||||t-test, 2 sided|||null hypothesis was that there would be no difference in adipose tissue insulin sensitivity due to IHTG levels.||||<0.002
71029148|NCT00262964|141565872|SUPERIORITY_OR_OTHER|||||||0.301||95.0||||A P-value \< 0.05 was considered statistically significant.|t-test, 2 sided|Treatment effects determined by repeated-measures ANOVA. When significant interactions between time and group were found, a Student's t-test was used.||Student's t-test for paired samples was used to evaluate any difference between the two groups. The null hypothesis was that the IHTG percentage would be the same before and after treatment for subjects receiving fenofibrate.||||.301
71029149|NCT00262964|141565872|SUPERIORITY_OR_OTHER|||||||0.315||95.0||||A P-value \< 0.05 was considered statistically significant.|t-test, 2 sided|Treatment effects determined by repeated-measures ANOVA. When significant interactions between time and group were found, a Student's t-test was used.||A Student's t-test for paired samples was used to evaluate the effect of treatment. The null hypothesis was that the IHTG percentage for the NAFLD-niacin group at baseline and post-treatment would not change.||||.315
71104112|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|-10.0|||||TWO_SIDED|95.0|-41.2|16.6||||||At risk subjects.||16.6|-41.2|
70928819|NCT04800211|141353102|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.401||||0.2002|TWO_SIDED|95.0|-0.213|1.016|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||1.016|-0.213|0.2002
70928820|NCT04800211|141353102|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-0.29||||0.476|TWO_SIDED|95.0|-1.089|0.509|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||0.509|-1.089|0.4760
70941464|NCT04341584|141383704|SUPERIORITY||Cox Proportional Hazard|1.22|||||TWO_SIDED|95.0|0.31|4.87|||Regression, Cox|adjusted on age and centre||||4.87|0.31|
70941465|NCT04341584|141383705|SUPERIORITY||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-8.3|6.4||||adjusted on age and centre||||6.4|-8.3|
70941466|NCT04341584|141383707|SUPERIORITY||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.64|1.61|||Fine-Gray model|Adjusted for age and centre||||1.61|0.64|
70941467|NCT04341584|141383707|SUPERIORITY||Hazard Ratio (HR)|1.33|||||TWO_SIDED|95.0|0.58|3.07||Adjusted for age and centre|Fine-Gray model|Adjusted for age and centre||||3.07|0.58|
71013657|NCT02163759|141533976|SUPERIORITY||Mean Difference (Net)|-0.7||||0.3708|TWO_SIDED|95.0|-2.4|0.9||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||0.9|-2.4|0.3708
71013658|NCT02163759|141533976|SUPERIORITY||Mean Difference (Net)|-0.5||||0.4477|TWO_SIDED|95.0|-1.8|0.8||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||0.8|-1.8|0.4477
71013659|NCT02163759|141533977|SUPERIORITY||Mean Difference (Net)|-1.0||||1|TWO_SIDED|95.0|-2.1|0.2||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 4 of the testing procedure; please refer to the statistical analysis plan for details.||0.2|-2.1|1
71029150|NCT00262964|141565873|SUPERIORITY_OR_OTHER|||||||0.708||95.0||||A P-value \< 0.05 was considered statistically significant.|t-test, 2 sided|||a Student's t-test for paired samples was used to evaluate the effect of treatment. Null hypothesis was that VLDL-apoB would be the same before and after 16 weeks on niacin in subjects with NAFLD.||||0.708
71104113|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|25.0|||||TWO_SIDED|95.0|-7.1|53.9||||||At risk subjects.||53.9|-7.1|
71104114|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|8.0|||||TWO_SIDED|95.0|1.0|16.4||||||No risk subjects.||16.4|1|
71104115|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|8.0|||||TWO_SIDED|95.0|2.0|16.1||||||No risk subjects.||16.1|2|
71104116|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|4.0|||||TWO_SIDED|95.0|0.0|10.0||||||No risk subjects.||10|0|
71104117|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-1.0|||||TWO_SIDED|95.0|-42.1|43.0||||||At risk subjects.||43|-42.1|
71013660|NCT02163759|141533977|SUPERIORITY||Mean Difference (Net)|-0.3||||1|TWO_SIDED|95.0|-1.2|0.7||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 6 of the testing procedure; please refer to the statistical analysis plan for details.||0.7|-1.2|1
70941468|NCT04341584|141383708|SUPERIORITY||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.56|1.48|||Fine-Gray model|adjusted on age and centre||||1.48|0.56|
71013661|NCT02163759|141533978|SUPERIORITY||Mean Difference (Net)|-0.2||||0.6356|TWO_SIDED|95.0|-0.9|0.5||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||0.5|-0.9|0.6356
71047931|NCT00369382|141604932|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 24||||0.002
71047932|NCT00369382|141604932|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 32||||0.030
71047933|NCT00369382|141604932|SUPERIORITY_OR_OTHER|||||||0.121|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 40||||0.121
71047934|NCT00369382|141604932|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 52||||0.001
71047935|NCT00369382|141604934|SUPERIORITY_OR_OTHER||slope difference (CNI - SRL)|-2.311||||0.126|TWO_SIDED|95.0|-5.282|0.66||alpha is unadjusted|Random coefficient model||Random coefficient model with each participant's creatinine clearance function of time on treatment; intra-subject regression coefficients considered random.|||0.660|-5.282|0.126
71104118|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|-10.0|||||TWO_SIDED|95.0|-41.5|28.7||||||At risk subjects||28.7|-41.5|
71104119|NCT01346592|141715389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|0.0|||||TWO_SIDED|95.0|-29.0|36.8||||||At risk subjects.||36.8|-29|
71047936|NCT00369382|141604936|SUPERIORITY_OR_OTHER|||||||0.206|TWO_SIDED|||||alpha is unadjusted|Fisher Exact|||For-cause Biopsy-Confirmed Acute Rejection compared between treatment groups||||0.206
71047937|NCT00369382|141604936|SUPERIORITY_OR_OTHER|||||||0.476|TWO_SIDED|||||alpha is unadjusted|Fisher Exact|||Standard of Care Biopsy-Confirmed Acute Rejection compared between treatment groups||||0.476
71104120|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|10.0|||||TWO_SIDED|95.0|6.4|12.8||||||No risk subjects.||12.8|6.4|
71047938|NCT01673698|141604942|SUPERIORITY_OR_OTHER|||||||0.0041|TWO_SIDED||||||t-test, 1 sided|||||||0.0041
71047939|NCT01673698|141604943|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 1 sided|||||||<0.0001
71047940|NCT01673698|141604944|SUPERIORITY_OR_OTHER|||||||0.561|TWO_SIDED||||||Chi-squared|||||||0.5610
71047941|NCT00507546|141604945|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED|95.0|||||Friedman|||||||0.70
71047942|NCT00507546|141604946|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||Friedman|||||||0.35
71047943|NCT00609466|141604963|SUPERIORITY_OR_OTHER||Least square mean|70.8|||<|0.0001||95.0|35.9|105.6||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.||105.6|35.9|<0.0001
71047944|NCT00609466|141604964|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Test for time (in hours) to first rescue medication use. No multiplicity adjustment.|Log Rank|Adjusted for site||||||<0.0001
71047945|NCT00609466|141604965|SUPERIORITY_OR_OTHER||Least square mean|37.5|||<|0.0001||95.0|22.7|52.2||No multiplicity adjustment used|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.||52.2|22.7|<0.0001
71047946|NCT00609466|141604966|SUPERIORITY_OR_OTHER||Least square means|9.9|||<|0.0001||95.0|6.2|13.6||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.||13.6|6.2|<0.0001
71047947|NCT00609466|141604967|SUPERIORITY_OR_OTHER||Least square mean|20.6|||<|0.0001||95.0|13.2|28.0||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.||28.0|13.2|<0.0001
71104121|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|4.0|||||TWO_SIDED|95.0|1.8|6.4||||||No risk subjects.||6.4|1.8|
70941469|NCT04341584|141383708|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.35|2.34||adjusted on age and centre|Fine-Gray model|||||2.34|0.35|
71047948|NCT00609466|141604968|SUPERIORITY_OR_OTHER||Least square mean|36.4|||<|0.0001||95.0|20.7|52.0||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.||52.0|20.7|<0.0001
71047949|NCT00609466|141604969|SUPERIORITY_OR_OTHER||Least square means|108.2||||0.0002||95.0|51.9|164.5||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.||164.5|51.9|0.0002
70941470|NCT04341584|141383709|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.43|2.32||adjusted on age and centre|Fine-Gray model|||Day 28||2.32|0.43|
70928821|NCT04800211|141353102|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-0.699||||0.0914|TWO_SIDED|95.0|-1.512|0.113|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||0.113|-1.512|0.0914
70928822|NCT04800211|141353102|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|0.328||||0.9705|TWO_SIDED|95.0|-1.122|1.777|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||1.777|-1.122|0.9705
70941471|NCT04341584|141383709|SUPERIORITY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.52|2.29||adjusted on age and centre|Fine-Gray model|||Day 90||2.29|0.52|
71013662|NCT02163759|141533978|SUPERIORITY||Mean Difference (Net)|-0.4||||0.1253|TWO_SIDED|95.0|-1.0|0.1||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||0.1|-1.0|0.1253
71013663|NCT02163759|141533979|SUPERIORITY||Mean Difference (Net)|-0.5||||1|TWO_SIDED|95.0|-1.0|0.0||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 4 of the testing procedure; please refer to the statistical analysis plan for details.||0.0|-1.0|1
71013664|NCT02163759|141533979|SUPERIORITY||Mean Difference (Net)|-0.3||||1|TWO_SIDED|95.0|-0.7|0.1||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 6 of the testing procedure; please refer to the statistical analysis plan for details.||0.1|-0.7|1
71104122|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|11.0|||||TWO_SIDED|95.0|8.6|13.9||||||No risk subjects.||13.9|8.6|
71013665|NCT02163759|141533980|SUPERIORITY||Difference in Remission Rates|10.9||||0.0364|TWO_SIDED|95.0|-0.08|19.48||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||19.48|-0.08|0.0364
71029151|NCT00262964|141565873|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||A P-value \< 0.05 was considered statistically significant.|t-test, 2 sided|||A Student's t-test for paired samples was used to evaluate the effect of treatment. Null hypothesis was that VLDL-apoB would be the same before and after 8 weeks on fenofibrate in subjects with NAFLD.||||.022
71029152|NCT00262964|141565874|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||the null hypothesis was that fenofibrate would not change the VLDL-Tg clearance rate||||.020
71029153|NCT00262964|141565874|SUPERIORITY_OR_OTHER|||||||0.358||95.0||||a priori threshold for significance was \<0.05.|t-test, 2 sided|||the null hypothesis was that niacin would not change the VLDL-Tg clearance rate||||.358
71029154|NCT00262964|141565875|SUPERIORITY_OR_OTHER|||||||0.758||95.0||||a priori threshold for statistical significance was set at \<0.05.|t-test, 2 sided|||Null hypothesis is that fenofibrate would not effect VLDL-Tg production rates.||||0.758
71029155|NCT00262964|141565875|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||the a priori threshold for statistical significance was set at \<0.05.|t-test, 2 sided|||Null hypothesis is that niacin would not effect VLDL-Tg production rates.||||.023
71029156|NCT00262964|141565876|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||the a priori threshold for statistical significance was p \<0.05|t-test, 2 sided|||Null hypothesis was that fenofibrate would not affect VLDL-Tg concentration. We compare the pre and post-treatment results of subjects receiving an 8 week course of fenofibrate.||||.024
71029157|NCT00262964|141565876|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||the a priori threshold for statistical significance was p\<0.05|t-test, 2 sided|||The null hypothesis was that niacin would not affect VLDL-Tg concentration. We compare the pre and post-treatment results of subjects receiving a 16 week course of niacin.||||<0.001
70941472|NCT00332488|141383772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.42|TWO_SIDED|95.0|-0.11|0.27|||ANCOVA|||ANCOVA fitting model change from baseline in A1c with fixed effects for treatment and pooled site and baseline A1c as a covariate||0.27|-0.11|0.420
71013666|NCT02163759|141533980|SUPERIORITY||Difference in Remission Rates|-4.5||||0.3383|TWO_SIDED|95.0|-14.1|5.07||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||5.07|-14.10|0.3383
71013667|NCT02163759|141533981|SUPERIORITY||Difference in Remission Rates|6.2||||0.09|TWO_SIDED|95.0|-3.33|12.3||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||12.30|-3.33|0.0900
71013668|NCT02163759|141533981|SUPERIORITY||Difference in Remission Rates|-3.6||||0.3217|TWO_SIDED|95.0|-11.07|3.78||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||3.78|-11.07|0.3217
71013669|NCT02163759|141533982|SUPERIORITY||Difference in Adjusted Means|1.3||||0.7919|TWO_SIDED|95.0|-8.3|10.8||Nominal p-value; it has not been adjusted for multiplicity.|ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and IBDQ score at BL.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||10.8|-8.3|0.7919
71029158|NCT00262964|141565877|SUPERIORITY_OR_OTHER|||||||0.768||95.0||||A priori threshold for significance was set for p\<0.05.|t-test, 2 sided|||Null hypothesis was that fenofibrate would not affect adipose tissue insulin sensitivity. We compare the baseline and post-treatment results for adipose tissue insulin sensitivity in the subjects who received fenofibrate.||||.768
71029159|NCT00262964|141565877|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||A priori threshold for significance was set for p\<0.05.|t-test, 2 sided|||Null hypothesis was that niacin would not affect adipose tissue insulin sensitivity. Here we compare the baseline and post-treatment adipose tissue insulin sensitivity results for subjects who received a 16 week course of niacin||||.019
71029160|NCT00262964|141565878|SUPERIORITY_OR_OTHER|||||||0.318||95.0||||The a priori threshold for significance was set at p\<0.05.|t-test, 2 sided|||The null hypothesis was that fenofibrate would not affect skeletal muscle insulin sensitivity. Here we compare the pre and post-treatment results in subjects receiving an 8 week course of fenofibrate.||||.318
71029161|NCT00262964|141565878|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||The a priori threshold for significance was set at p\<0.05.|t-test, 2 sided|||The null hypothesis was that niacin would not affect skeletal muscle insulin sensitivity. Here we compare the pre and post-treatment results for subjects receiving a 16 week course of niacin.||||.025
71029162|NCT00262964|141565879|SUPERIORITY_OR_OTHER|||||||0.419||95.0||||The a priori threshold for significance was set at p\<0.05.|t-test, 2 sided|||The null hypothesis was that fenofibrate would not affect hepatic insulin sensitivity. Here we compare the pre and post-treatment results of subjects receiving an 8 week course of fenofibrate.||||.419
71029163|NCT00262964|141565879|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||The a priori threshold for significance was set at p\<0.05.|t-test, 2 sided|||The null hypothesis was that niacin would not affect skeletal muscle insulin sensitivity. Here we compare the pre and post-treatment results of subjects receiving a 16 week course of niacin.||||.018
71029164|NCT03130699|141565894|SUPERIORITY|||||||0.95|||||||Regression, Logistic|||Analyses controlled for age, gender, employment and language.||||0.95
71029165|NCT03130699|141565895|SUPERIORITY|||||||0.37|||||||Regression, Logistic|||Analyses controlled for age, gender, employment, and language.||||0.37
71029166|NCT03130699|141565896|SUPERIORITY|||||||0.26|||||||Regression, Logistic|||Analyses controlled for age, gender, employment, and language.||||0.26
71029167|NCT03130699|141565897|SUPERIORITY|||||||0.9|||||||Regression, Logistic|||Analyses controlled for age, gender, employment, and language.||||0.90
71029168|NCT03130699|141565898|SUPERIORITY|||||||0.21|||||||Regression, Logistic|||Analyses controlled for age, gender, employment, and language.||||0.21
71029169|NCT03130699|141565899|SUPERIORITY|||||||0.3|||||||Regression, Logistic|||Analyses controlled for age, gender, employment, and language.||||0.30
71029170|NCT03130699|141565900|SUPERIORITY|||||||0.9|||||||Regression, Logistic|||Analyses controlled for income.||||0.90
71029171|NCT03130699|141565901|SUPERIORITY|||||||0.72|||||||Regression, Logistic|||Analyses controlled for income.||||0.72
70941473|NCT00332488|141383773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91|||<|0.001|TWO_SIDED|95.0|0.69|1.14|||ANCOVA|Type III||ANCOVA fitting model change from baseline in A1c with fixed effects for treatment and pooled site and baseline A1c as a covariate||1.14|0.69|< 0.001
70941474|NCT02983877|141383776|SUPERIORITY||||||<|0.001|||||||Friedman test|3 degrees of freedom||||||<0.001
70941475|NCT02983877|141383777|SUPERIORITY||||||<|0.001|||||||ANOVA|3 degrees of freedom||||||<0.001
70928823|NCT04800211|141353102|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.977||||0.328|TWO_SIDED|95.0|-0.512|2.465|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||2.465|-0.512|0.3280
70928824|NCT04800211|141353102|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-0.218||||0.9951|TWO_SIDED|95.0|-1.667|1.23|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||1.230|-1.667|0.9951
70928825|NCT04800211|141353102|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.225||||0.1367|TWO_SIDED|95.0|-0.244|2.693|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||2.693|-0.244|0.1367
70941476|NCT02983877|141383778|SUPERIORITY||||||<|0.001|||||||Friedman test|3 degrees of freedom||||||<0.001
70941477|NCT02983877|141383779|SUPERIORITY|||||||0.89|||||||ANOVA|2 degrees of freedom||||||0.89
70941478|NCT03721978|141383780|SUPERIORITY|Superiority was concluded if the one-sided p-value was \<0.025 and the corresponding lower bound of the 95% CI exceeded zero (0).|Difference in Percentage|28.6||||0.115|TWO_SIDED|95.0|-24.6|50.4|||Miettinen and Nurminen method|||||50.4|-24.6|0.115
70941479|NCT03721978|141383785|SUPERIORITY|Superiority was concluded if the one-sided p-value was \<0.025 and the corresponding lower bound of the 95% CI exceeded zero (0).|Difference in Percentage|18.9||||0.001|TWO_SIDED|95.0|7.8|28.6|||Miettinen and Nurminen method|||||28.6|7.8|0.001
71013670|NCT02163759|141533982|SUPERIORITY||Difference in Adjusted Means|-0.8||||0.8327|TWO_SIDED|95.0|-8.7|7.0||Nominal p-value; it has not been adjusted for multiplicity.|ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and IBDQ score at BL.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||7.0|-8.7|0.8327
71013671|NCT02777554|141534068|EQUIVALENCE|Equivalent exposure of the QD formulation to the BID tablet was established if the 90% confidence intervals (CIs) of the geometric mean ratio for Day 7 AUC0-24 and Cmax were completely contained within the range of 80% to 125%.|Ratio (%) of Geometric Means|101.6|||||TWO_SIDED|90.0|95.1|108.5|||||Geometric mean ratio (Apremilast 75 mg XL QD / Apremilast 30 mg IR BID) from an ANOVA model, expressed as a percentage.|To assess the exposure between the extended release apremilast formulation, and Reference IR (30 mg reference IR BID) tablet following multiple oral doses, an analysis of variance (ANOVA) model, with sequence, period, and treatment as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Day 7 Cmax.||108.5|95.1|
71013672|NCT02777554|141534069|EQUIVALENCE|Equivalent exposure of the QD formulation to the BID tablet was established if the 90% CIs of the geometric mean ratio for Day 7 AUC0-24 and Cmax were completely contained within the range of 80% to 125%.|Ratio (%) of Geometric Means|95.3|||||TWO_SIDED|90.0|88.9|102.2|||||Geometric mean ratio (Apremilast 75 mg XL QD / Apremilast 30 mg IR BID) from an ANOVA model, expressed as a percentage.|To assess the exposure between the extended release apremilast formulation, and Reference IR (30 mg reference IR BID) tablet following multiple oral doses, an ANOVA model, with sequence, period, and treatment as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Day 7 AUC0-24.||102.2|88.9|
71029172|NCT03130699|141565902|SUPERIORITY|||||||0.61|||||||Regression, Logistic|||Analyses controlled for income.||||0.61
71029173|NCT03130699|141565903|SUPERIORITY|||||||0.49|||||||Regression, Logistic|||Analyses controlled for income.||||0.49
71029174|NCT03130699|141565904|SUPERIORITY|||||||0.96|||||||Regression, Logistic|||Analyses controlled for income.||||0.96
71029175|NCT03130699|141565905|SUPERIORITY|||||||0.64|||||||Regression, Logistic|||Analyses controlled for income.||||0.64
71029176|NCT03130699|141565906|SUPERIORITY|||||||0.87|||||||Regression, Logistic|||Binary logistic analyses were conducted for this outcome. Unstandardized regression coefficients represent logit coefficients.||||0.87
71029177|NCT03130699|141565907|SUPERIORITY|||||||0.58|||||||Regression, Logistic|||Binary logistic regression analyses were conducted for this outcome. Unstandardized regression coefficients represent logit coefficients.||||0.58
71029178|NCT03130699|141565908|SUPERIORITY|||||||0.25|||||||Regression, Logistic|||Binary logistic regression analyses were conducted for this outcome. Unstandardized regression coefficients represent logit coefficients.||||0.25
70928826|NCT04800211|141353102|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.101||||0.0294|TWO_SIDED|95.0|0.111|2.091|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||2.091|0.111|0.0294
70928827|NCT04800211|141353102|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-0.248||||0.6792|TWO_SIDED|95.0|-1.424|0.928|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||0.928|-1.424|0.6792
70928828|NCT04800211|141353103|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.638||||0.4012|TWO_SIDED|95.0|-0.86|2.137|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||2.137|-0.860|0.4012
70928829|NCT04800211|141353103|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|2.163||||0.0201|TWO_SIDED|95.0|0.343|3.983|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.983|0.343|0.0201
70928830|NCT04800211|141353103|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.21||||0.1709|TWO_SIDED|95.0|-0.528|2.948|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||2.948|-0.528|0.1709
70941480|NCT03721978|141383786|OTHER||Difference in Percentage|13.1|||||TWO_SIDED|95.0|-37.7|46.0||||||||46.0|-37.7|
70941481|NCT03721978|141383787|OTHER||Difference in Percentage|12.6|||||TWO_SIDED|95.0|-0.8|24.5||||||||24.5|-0.8|
70941482|NCT03721978|141383788|OTHER||Difference in Percentage|38.1|||||TWO_SIDED|95.0|-15.7|59.5||||||||59.5|-15.7|
70941483|NCT03721978|141383789|OTHER||Difference in Percentage|27.9|||||TWO_SIDED|95.0|16.0|38.2||||||||38.2|16.0|
71047950|NCT03512262|141604970|SUPERIORITY||Least Squares (LSM) Means Difference|7.3165|||<|0.0001|TWO_SIDED|99.0|5.0668|9.5663||Significance level of 0.01.|ANCOVA|Missing values were imputed using a multiple imputation method.||||9.5663|5.0668|<0.0001
71047951|NCT03512262|141604971|SUPERIORITY||LSM Difference|2.1209|||<|0.0001|TWO_SIDED|99.0|0.9948|3.2469||Significance level of 0.01.|ANCOVA|Missing values were imputed using a multiple imputation method.||||3.2469|0.9948|<0.0001
71047952|NCT03512262|141604972|SUPERIORITY||LSM Difference|2.8221|||<|0.0001|TWO_SIDED|99.0|1.3972|4.2471||Significance level of 0.01.|ANCOVA|Missing values were imputed using a multiple imputation method.||||4.2471|1.3972|<0.0001
71047953|NCT04551911|141605030|OTHER|||||||0.7856|||||||Regression, Logistic|Logistic regression with treatment as the main effect, and baseline aggregate symptom score, baseline 25D level, and body weight as covariates||||||0.7856
70928831|NCT04800211|141353103|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.593||||0.0307|TWO_SIDED|95.0|0.15|3.035|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.035|0.150|0.0307
70928832|NCT04800211|141353103|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.588||||0.0691|TWO_SIDED|95.0|-0.126|3.302|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.302|-0.126|0.0691
70941484|NCT03721978|141383790|OTHER||Difference in Percentage|13.1|||||TWO_SIDED|95.0|-37.7|46.0||||||||46.0|-37.7|
70941485|NCT03721978|141383791|OTHER||Difference in Percentage|17.6|||||TWO_SIDED|95.0|5.2|28.5||||||||28.5|5.2|
70941486|NCT03721978|141383792|OTHER||Difference in Percentage|28.6|||||TWO_SIDED|95.0|-24.6|50.4||||||||50.4|-24.6|
71047954|NCT01030341|141605038|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Type I error: 0.05; power: 0.9|||||<|0.0001||||||Threshold for statistical significance: p \< 0.05|Regression, Logistic|Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases||Null hypothesis: Difference of 0% in the frequencies of hypoglycemic excursions (\<50 mg/dL) during the screening phase and treatment phase respectively.||||<0.0001
71104123|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-4.0|||||TWO_SIDED|95.0|-24.7|14.9||||||At risk subjects.||14.9|-24.7|
71104124|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|4.0|||||TWO_SIDED|95.0|-14.4|20.7||||||At risk subjects.||20.7|-14.4|
71047955|NCT01030341|141605038|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Type I error: 0.05; power: 0.9|||||<|0.0001||||||Threshold for statistical significance: p \< 0.05|Regression, Logistic|Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases||Null hypothesis: Difference of 0% in the frequencies of hypoglycemic excursions (\<70 mg/dL) during the screening phase and treatment phase respectively.||||<0.0001
71047956|NCT01030341|141605038|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Type I error: 0.05; power: 0.9||||||0.005||||||Threshold for statistical significance: p \< 0.05|Regression, Logistic|Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases||Null hypothesis: Difference of 0% in the frequencies of euglycemic excursions (70-180 mg/dL) during the screening phase and treatment phase respectively.||||0.005
71047957|NCT01030341|141605038|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Type I error: 0.05; power: 0.9||||||0.04||||||Threshold for statistical significance: p \< 0.05|Regression, Logistic|Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases||Null hypothesis: Difference of 0% in the frequencies of hyperglycemic excursions (\>180 mg/dL) during the screening phase and treatment phase respectively.||||0.04
71047958|NCT01030341|141605038|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Type I error: 0.05; power: 0.9|||||<|0.0001||||||Threshold for statistical significance: p \< 0.05|Regression, Logistic|Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases||Null hypothesis: Difference of 0% in the frequencies of hyperglycemic excursions (\>300 mg/dL) during the screening phase and treatment phase respectively.||||<0.0001
70941487|NCT03721978|141383793|OTHER||Difference in Percentage|20.3|||||TWO_SIDED|95.0|10.1|29.5||||||||29.5|10.1|
70941488|NCT03721978|141383794|OTHER||Difference in Percentage|1.2|||||TWO_SIDED|95.0|-31.2|50.5||||||||50.5|-31.2|
70941489|NCT03721978|141383795|OTHER||Difference in Percentage|5.3|||||TWO_SIDED|95.0|-6.0|17.9||||||||17.9|-6.0|
71047959|NCT01030341|141605039|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in total GCSI score from screening to 12 weeks of treatment.||||<0.0001
71047960|NCT01030341|141605039|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in total GCSI score from screening to 24 weeks of treatment.||||<0.0001
71047961|NCT01030341|141605039|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in GCSI composite score from screening to 12 weeks of treatment.||||<0.0001
71104125|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|9.0|||||TWO_SIDED|95.0|-6.8|23.4||||||At risk subjects.||23.4|-6.8|
71104126|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|15.0|||||TWO_SIDED|95.0|11.3|18.1||||||No risk subjects.||18.1|11.3|
70928833|NCT04800211|141353103|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|2.487||||0.0034|TWO_SIDED|95.0|0.838|4.137|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||4.137|0.838|0.0034
70928834|NCT04800211|141353103|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.849||||0.0034|TWO_SIDED|95.0|0.622|3.075|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.075|0.622|0.0034
70928835|NCT04800211|141353103|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.178||||0.8123|TWO_SIDED|95.0|-1.654|1.299|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||1.299|-1.654|0.8123
70928836|NCT04800211|141353103|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.48||||0.5879|TWO_SIDED|95.0|-2.226|1.267|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||1.267|-2.226|0.5879
70941490|NCT03721978|141383796|OTHER||Difference in Percentage|-6.0|||||TWO_SIDED|95.0|-54.7|25.8||||||||25.8|-54.7|
70941491|NCT03721978|141383797|OTHER||Difference in Percentage|12.2|||||TWO_SIDED|95.0|1.1|21.9||||||||21.9|1.1|
70941492|NCT03721978|141383798|OTHER||Location Shift|449.0|||||TWO_SIDED|95.0|0.0|18224.0||||||Week 15: HPV-16 E7||18224.0|0.0|
71047962|NCT01030341|141605039|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in GCSI composite score from screening to 24 weeks of treatment.||||<0.0001
71047963|NCT01030341|141605039|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in PAGI-QOL score from screening to 12 weeks of treatment.||||<0.0001
71047964|NCT01030341|141605039|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in PAGI-QOL score from screening to 24 weeks of treatment.||||<0.0001
71047965|NCT00609518|141605078|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.09|||||TWO_SIDED|95.0|-0.1|0.28|||Linear probability model|||||0.28|-0.10|
70850415|NCT01708902|141188566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.31|STANDARD_ERROR_OF_MEAN|3.17|<|0.0001|TWO_SIDED|95.0|-30.54|-18.08|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Linagliptin 5mg QD'.|The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.||-18.08|-30.54|<0.0001
71047966|NCT00609518|141605079|SUPERIORITY_OR_OTHER|||||||0.4902||95.0|||||Fisher Exact|||||||0.4902
71047967|NCT00609518|141605080|SUPERIORITY_OR_OTHER|||||||0.6791||95.0|||||Log Rank|||||||0.6791
71047968|NCT00609518|141605080|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.54|1.49|||Regression, Cox|Treatment was the covariate included in this model.||||1.49|0.54|
71047969|NCT00609518|141605081|SUPERIORITY_OR_OTHER|||||||0.587||95.0|||||Log Rank|||||||0.5870
71047970|NCT00609518|141605081|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.57|1.38|||Regression, Cox|Treatment was the covariate included in this model.||||1.38|0.57|
70928837|NCT04800211|141353103|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.596||||0.491|TWO_SIDED|95.0|-2.304|1.111|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||1.111|-2.304|0.4910
70941493|NCT03721978|141383798|OTHER||Location Shift|0.0|||||TWO_SIDED|95.0|-18224.0|674.0||||||Week 36: HPV-16 E7||674.0|-18224.0|
70941494|NCT03721978|141383798|OTHER||Location Shift|4049.0|||||TWO_SIDED|95.0|224.0|18224.0||||||Week 15: HPV-18 E7||18224.0|224.0|
71104127|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|7.0|||||TWO_SIDED|95.0|4.2|9.1||||||No risk subjects.||9.1|4.2|
71104128|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|13.0|||||TWO_SIDED|95.0|10.5|16.1||||||No risk subjects.||16.1|10.5|
71104129|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-4.0|||||TWO_SIDED|95.0|-25.3|15.4||||||At risk subjects||15.4|-25.3|
71104130|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|6.0|||||TWO_SIDED|95.0|-12.7|24.2||||||At risk subjects.||24.2|-12.7|
71104131|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group differences (B strain)|8.0|||||TWO_SIDED|95.0|-7.8|23.2||||||At risk subjects.||23.2|-7.8|
71104132|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|12.0|||||TWO_SIDED|95.0|8.2|15.3||||||No risk subjects.||15.3|8.2|
71104133|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|5.0|||||TWO_SIDED|95.0|2.5|7.4||||||No risk subjects.||7.4|2.5|
71104134|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|12.0|||||TWO_SIDED|95.0|9.2|15.3||||||No risk subjects.||15.3|9.2|
71104135|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-2.0|||||TWO_SIDED|95.0|-28.5|20.2||||||At risk subjects.||20.2|-28.5|
71104136|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|11.0|||||TWO_SIDED|95.0|-14.9|33.5||||||At risk subjects.||33.5|-14.9|
71104137|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|2.0|||||TWO_SIDED|95.0|-20.7|19.7||||||At risk subjects.||19.7|-20.7|
70941495|NCT03721978|141383798|OTHER||Location Shift|74.0|||||TWO_SIDED|95.0|-18000.0|6074.0||||||Week 36: HPV-18 E7||6074.0|-18000.0|
70941496|NCT03721978|141383799|OTHER||Location Shift|224.0|||||TWO_SIDED|95.0|224.0|674.0||||||Week 15: HPV-16 E7||674.0|224.0|
70941497|NCT03721978|141383799|OTHER||Location Shift|0.0|||||TWO_SIDED|95.0|0.0|24.0||||||Week 36: HPV-16 E7||24.0|0.0|
70941498|NCT03721978|141383799|OTHER||Location Shift|2024.0|||||TWO_SIDED|95.0|2024.0|6074.0||||||Week 15: HPV-18 E7||6074.0|2024.0|
70941499|NCT03721978|141383799|OTHER||Location Shift|674.0|||||TWO_SIDED|95.0|224.0|674.0||||||Week 36: HPV-18 E7||674.0|224.0|
70941500|NCT03721978|141383800|OTHER||Location Shift|25.0|||||TWO_SIDED|95.0|0.0|73.33||||||HPV-16 E6: Week 15||73.33|0.00|
70941501|NCT03721978|141383800|OTHER||Location Shift|15.0|||||TWO_SIDED|95.0|0.0|38.33||||||HPV-16 E6: Week 36||38.33|0.00|
71104138|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|16.0|||||TWO_SIDED|95.0|12.6|20.1||||||No risk subjects.||20.1|12.6|
71104139|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|7.0|||||TWO_SIDED|95.0|4.6|9.8||||||No risk subjects||9.8|4.6|
71104140|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|15.0|||||TWO_SIDED|95.0|11.9|18.3||||||No risk subjects.||18.3|11.9|
71104141|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-2.0|||||TWO_SIDED|95.0|-28.5|20.2||||||At risk subjects.||20.2|-28.5|
71104142|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|11.0|||||TWO_SIDED|95.0|-14.9|33.5||||||At risk subjects.||33.5|-14.9|
71104143|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|10.0|||||TWO_SIDED|95.0|-14.0|29.3||||||At risk subjects.||29.3|-14|
71104144|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|2.0|||||TWO_SIDED|95.0|-3.8|9.5||||||No risk subjects.||9.5|-3.8|
70928838|NCT04800211|141353103|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.816||||0.9673|TWO_SIDED|95.0|-1.967|3.599|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.599|-1.967|0.9673
70928839|NCT04800211|141353103|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|2.643||||0.1787|TWO_SIDED|95.0|-0.683|5.968|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||5.968|-0.683|0.1787
70928840|NCT04800211|141353103|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.806||||0.5243|TWO_SIDED|95.0|-1.406|5.018|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||5.018|-1.406|0.5243
70941502|NCT03721978|141383800|OTHER||Location Shift|16.67|||||TWO_SIDED|95.0|0.0|85.0||||||HPV-16 E7: Week 15||85.00|0.00|
70941503|NCT03721978|141383800|OTHER||Location Shift|5.0|||||TWO_SIDED|95.0|0.0|36.67||||||HPV-16 E7: Week 36||36.67|0.00|
70941504|NCT03721978|141383800|OTHER||Location Shift|26.67|||||TWO_SIDED|95.0|0.0|181.67||||||HPV-18 E6: Week 15||181.67|0.00|
71104145|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|3.0|||||TWO_SIDED|95.0|-1.8|10.0||||||No risk subjects.||10|-1.8|
71047971|NCT00292188|141605083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.24||0.01||95.0|-1.09|-0.15|||ANCOVA|ANCOVA adjusted for treatment group, baseline mean pain score and pooled country||The study is powered to detect a clinically significant difference of 1 between treatment groups in the weekly mean pain score. Null hypothesis was that there was no difference in weekly mean pain scores between pregabalin and placebo.||-0.15|-1.09|0.010
71047972|NCT00292188|141605084|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.39||0.031||95.0|-1.6|-0.08|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||||-0.08|-1.60|0.031
71047973|NCT00292188|141605085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.32||0.003||95.0|-1.61|-0.33|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||||-0.33|-1.61|0.003
71047974|NCT00292188|141605086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.68|STANDARD_ERROR_OF_MEAN|1.0||0.099||95.0|-3.69|0.32|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||||0.32|-3.69|0.099
71104146|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|6.0|||||TWO_SIDED|95.0|1.5|12.5||||||No risk subjects.||12.5|1.5|
71047975|NCT00292188|141605087|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|1.03||0.819||95.0|-1.87|2.34|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||||2.34|-1.87|0.819
71047976|NCT00292188|141605088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.15||0.099||95.0|-0.56|0.05|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 1||0.05|-0.56|0.099
71047977|NCT00292188|141605088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.18||0.15||95.0|-0.62|0.1|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 2: FAS||0.10|-0.62|0.150
71104147|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-6.0|||||TWO_SIDED|95.0|-40.7|27.9||||||At risk subjects.||27.9|-40.7|
71104148|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|-9.0|||||TWO_SIDED|95.0|-38.4|14.3||||||At risk subjects.||14.3|-38.4|
70928841|NCT04800211|141353103|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.77||||0.3956|TWO_SIDED|95.0|-0.966|4.507|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||4.507|-0.966|0.3956
70928842|NCT04800211|141353103|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|2.068||||0.381|TWO_SIDED|95.0|-1.16|5.295|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||5.295|-1.160|0.3810
70928843|NCT04800211|141353103|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|3.084||||0.0557|TWO_SIDED|95.0|-0.049|6.216|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||6.216|-0.049|0.0557
70941505|NCT03721978|141383800|OTHER||Location Shift|11.67|||||TWO_SIDED|95.0|0.0|31.67||||||HPV-18 E6: Week 36||31.67|0.00|
70941506|NCT03721978|141383800|OTHER||Location Shift|3.33|||||TWO_SIDED|95.0|0.0|46.67||||||HPV-18 E7: Week 15||46.67|0.00|
70941507|NCT03721978|141383800|OTHER||Location Shift|4.17|||||TWO_SIDED|95.0|0.0|20.0||||||HPV-18 E7: Week 36||20.00|0.00|
70941508|NCT03721978|141383801|OTHER||Location Shift|8.33|||||TWO_SIDED|95.0|3.33|11.67||||||HPV-16 E6: Week 15||11.67|3.33|
71047978|NCT00292188|141605088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.2||0.01||95.0|-0.93|-0.13|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 3: FAS||-0.13|-0.93|0.010
71047979|NCT00292188|141605088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.21||0.137||95.0|-0.74|0.1|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 4: FAS||0.10|-0.74|0.137
71047980|NCT00292188|141605088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.22||0.041||95.0|-0.9|-0.02|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 5: FAS||-0.02|-0.90|0.041
71047981|NCT00292188|141605088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.22||0.009||95.0|-1.03|-0.15|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 6: FAS||-0.15|-1.03|0.009
71047982|NCT00292188|141605088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.25||0.035||95.0|-1.01|-0.04|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 7: FAS||-0.04|-1.01|0.035
70941509|NCT03721978|141383801|OTHER||Location Shift|5.83|||||TWO_SIDED|95.0|3.33|11.67||||||HPV-16 E6: Week 36||11.67|3.33|
70941510|NCT03721978|141383801|OTHER||Location Shift|5.0|||||TWO_SIDED|95.0|1.67|11.67||||||HPV-16 E7: Week 15||11.67|1.67|
70941511|NCT03721978|141383801|OTHER||Location Shift|1.67|||||TWO_SIDED|95.0|0.0|5.0||||||HPV-16 E7: Week 36||5.00|0.00|
70941512|NCT03721978|141383801|OTHER||Location Shift|25.0|||||TWO_SIDED|95.0|15.0|40.0||||||HPV-18 E6: Week 15||40.00|15.00|
71047983|NCT00292188|141605088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.25||0.019||95.0|-1.1|-0.1|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 8: FAS||-0.10|-1.10|0.019
71047984|NCT00292188|141605089|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.84||||0.032||95.0|1.05|3.21|||Regression, Logistic|logstic regression adjusted for treatment group, baseline pain score and pooled country.||30% responder||3.21|1.05|0.032
71047985|NCT00292188|141605089|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.78||||0.088||95.0|0.92|3.46|||Regression, Logistic|logstic regression adjusted for treatment group, baseline pain score and pooled country.||50% responder||3.46|0.92|0.088
71047986|NCT00292188|141605090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.23||0.001||95.0|-1.25|-0.34|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||||-0.34|-1.25|0.001
71104149|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|21.0|||||TWO_SIDED|95.0|-7.9|48.1||||||At risk subjects.||48.1|-7.9|
71104150|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|10.0|||||TWO_SIDED|95.0|3.0|18.5||||||No risk subjects.||18.5|3|
71104151|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|8.0|||||TWO_SIDED|95.0|2.2|15.6||||||No risk subjects.||15.6|2.2|
71104152|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|4.0|||||TWO_SIDED|95.0|0.0|9.6||||||No risk subjects.||9.6|0|
71104153|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-5.0|||||TWO_SIDED|95.0|-41.7|35.0||||||At risk subjects.||35|-41.7|
71104154|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|-9.0|||||TWO_SIDED|95.0|-38.6|23.4||||||At risk subjects.||23.4|-38.6|
71104155|NCT01346592|141715390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|0.0|||||TWO_SIDED|95.0|-26.9|31.0||||||At risk subjects.||31|-26.9|
71104156|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT Ratio (H1N1 strain)|2.29|||||TWO_SIDED|95.0|1.91|2.76||||||No risk subjects.||2.76|1.91|
71104157|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT Ratio (H3N2 strain)|1.6|||||TWO_SIDED|95.0|1.35|1.89||||||No risk subjects.||1.89|1.35|
71104158|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|2.92|||||TWO_SIDED|95.0|2.57|3.31||||||No risk subjects.||3.31|2.57|
70850416|NCT01708902|141188567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.21|STANDARD_ERROR_OF_MEAN|9.23||0.0002|TWO_SIDED|95.0|-53.48|-16.95|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'APG: Linagliptin 5mg QD'.|The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.||-16.95|-53.48|0.0002
70850417|NCT01708902|141188568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.209|STANDARD_ERROR_OF_MEAN|0.148||0.0271|TWO_SIDED|95.0|0.052|0.838|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c. The validity of the model is questionable as there is possibly a quasi-complete separation of data points, the results shown are based on the last maximum likelihood iteration."||0.838|0.052|0.0271
70850418|NCT01708902|141188568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.965|STANDARD_ERROR_OF_MEAN|0.916||0.9699|TWO_SIDED|95.0|0.15|6.202|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Metformin 500mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c. The validity of the model is questionable as there is possibly a quasi-complete separation of data points, the results shown are based on the last maximum likelihood iteration."||6.202|0.150|0.9699
70850419|NCT01708902|141188568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.183|STANDARD_ERROR_OF_MEAN|0.147||0.0343|TWO_SIDED|95.0|0.038|0.882|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c. The validity of the model is questionable as there is possibly a quasi-complete separation of data points, the results shown are based on the last maximum likelihood iteration."||0.882|0.038|0.0343
70941513|NCT03721978|141383801|OTHER||Location Shift|16.67|||||TWO_SIDED|95.0|10.0|28.33||||||HPV-18 E6: Week 36||28.33|10.00|
70941514|NCT03721978|141383801|OTHER||Location Shift|3.33|||||TWO_SIDED|95.0|1.67|6.67||||||HPV-18 E7: Week 15||6.67|1.67|
71104159|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.53|||||TWO_SIDED|95.0|0.6|3.93||||||At risk subjects.||3.93|0.6|
71104160|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.02|||||TWO_SIDED|95.0|0.89|4.61||||||At risk subjects.||4.61|0.89|
71104161|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|2.5|||||TWO_SIDED|95.0|1.34|4.67||||||At risk subjects.||4.67|1.34|
71104162|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|3.33|||||TWO_SIDED|95.0|2.77|4.01||||||No risk subjects.||4.01|2.77|
71104163|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.07|||||TWO_SIDED|95.0|1.75|2.45||||||No risk subjects||2.45|1.75|
71104164|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.08|||||TWO_SIDED|95.0|2.72|3.49||||||No risk subjects||3.49|2.72|
71104165|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.71|||||TWO_SIDED|95.0|0.65|4.5||||||At risk subjects.||4.5|0.65|
70941515|NCT03721978|141383801|OTHER||Location Shift|1.67|||||TWO_SIDED|95.0|0.0|3.33||||||HPV-18 E7: Week 36||3.33|0.00|
70941516|NCT03721978|141383802|OTHER||Location Shift|0.033|||||TWO_SIDED|95.0|-0.004|0.325||||||Parameter: CD8+CD137+Perforin+||0.325|-0.004|
70850420|NCT01708902|141188569|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.114|STANDARD_ERROR_OF_MEAN|0.125||0.0474|TWO_SIDED|95.0|0.013|0.976|||Regression, Logistic|||"Comparison of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' / 'APG: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||0.976|0.013|0.0474
70850421|NCT00800254|141188578|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
70850422|NCT00800254|141188580|SUPERIORITY_OR_OTHER||||||<|0.003|TWO_SIDED||||||ANCOVA|||||||<0.003
70941517|NCT03721978|141383802|OTHER||Location Shift|0.005|||||TWO_SIDED|95.0|0.0|0.208||||||Parameter: CD8+CD38+Perforin+||0.208|0.000|
70941518|NCT03721978|141383802|OTHER||Location Shift|0.014|||||TWO_SIDED|95.0|-0.055|0.31||||||Parameter: CD8+CD69+Perforin+||0.310|-0.055|
70941519|NCT03721978|141383803|OTHER||Location Shift|0.041|||||TWO_SIDED|95.0|0.004|0.077||||||Parameter: CD8+CD137+Perforin+||0.077|0.004|
70941520|NCT03721978|141383803|OTHER||Location Shift|0.011|||||TWO_SIDED|95.0|0.003|0.028||||||Parameter: CD8+CD38+Perforin+||0.028|0.003|
70941521|NCT03721978|141383803|OTHER||Location Shift|0.034|||||TWO_SIDED|95.0|0.022|0.053||||||Parameter: CD8+CD69+Perforin+||0.053|0.022|
70941522|NCT05244226|141383804|SUPERIORITY|||||||0.045|||||||Kruskal-Wallis|Dunn's Kruskal Wallis with Bonferroni correction||||||0.045
70928844|NCT04800211|141353103|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|2.445||||0.0195|TWO_SIDED|95.0|0.4|4.49|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||4.490|0.400|0.0195
70928845|NCT04800211|141353103|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-1.277||||0.2817|TWO_SIDED|95.0|-3.615|1.06|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||1.060|-3.615|0.2817
70928846|NCT05170841|141353119|SUPERIORITY||||||=|0.566|||||||t-test, 2 sided|||||||=0.566
70928847|NCT05170841|141353120|SUPERIORITY||||||=|0.013|||||||t-test, 2 sided|||||||=0.013
70928848|NCT05170841|141353121|SUPERIORITY||||||=|0.006|||||||t-test, 2 sided|||||||=0.006
70928849|NCT05170841|141353122|SUPERIORITY||||||=|0.013|||||||t-test, 2 sided|||||||=0.013
70928850|NCT05170841|141353123|SUPERIORITY||||||=|0.031|||||||t-test, 2 sided|||||||=0.031
70928851|NCT05170841|141353124|SUPERIORITY||||||=|0.027|||||||t-test, 2 sided|||||||=0.027
71104166|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|3.22|||||TWO_SIDED|95.0|1.38|7.51||||||At risk subjects.||7.51|1.38|
71104167|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|2.1|||||TWO_SIDED|95.0|1.1|3.98||||||At risk subjects.||3.98|1.1|
71104168|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H1N1 strain)|2.59|||||TWO_SIDED|95.0|2.1|3.21||||||No risk subjects.||3.21|2.1|
71104169|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H3N2 strain)|2.08|||||TWO_SIDED|95.0|1.71|2.52||||||No risk subjects.||2.52|1.71|
71104170|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (B strain)|3.73|||||TWO_SIDED|95.0|3.22|4.33||||||No risk subjects.||4.33|3.22|
71104171|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H1N1 strain)|1.4|||||TWO_SIDED|95.0|0.45|4.4||||||At risk subjects.||4.4|0.45|
70928852|NCT05170841|141353125|SUPERIORITY||||||=|0.011|||||||t-test, 2 sided|||||||=0.011
70928853|NCT05170841|141353126|SUPERIORITY||||||=|0.007|||||||t-test, 2 sided|||||||=0.007
70928854|NCT05170841|141353127|SUPERIORITY||||||=|0.013|||||||t-test, 2 sided|||||||=0.013
70928855|NCT05170841|141353128|SUPERIORITY||||||=|0.029|||||||t-test, 2 sided|||||||=0.029
70928856|NCT05170841|141353129|SUPERIORITY||||||=|0.022|||||||t-test, 2 sided|||||||=0.022
70928857|NCT05170841|141353130|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70928858|NCT05170841|141353131|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70928859|NCT05170841|141353132|SUPERIORITY||||||=|0.001|||||||t-test, 2 sided|||||||=0.001
71104172|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H3N2 strain)|2.86|||||TWO_SIDED|95.0|0.94|8.66||||||At risk subjects.||8.66|0.94|
70928860|NCT05170841|141353133|SUPERIORITY||||||=|0.01|||||||t-test, 2 sided|||||||=0.01
70928861|NCT05170841|141353134|SUPERIORITY||||||=|0.04|||||||t-test, 2 sided|||||||=0.04
70928862|NCT05170841|141353135|SUPERIORITY||||||=|0.016|||||||t-test, 2 sided|||||||=0.016
70928863|NCT05170841|141353136|SUPERIORITY||||||=|0.045|||||||t-test, 2 sided|||||||=0.045
70928864|NCT05170841|141353137|SUPERIORITY||||||=|0.042|||||||t-test, 2 sided|||||||=0.042
70928865|NCT05170841|141353138|SUPERIORITY||||||=|0.037|||||||t-test, 2 sided|||||||=0.037
71104173|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (B strain)|1.4|||||TWO_SIDED|95.0|0.45|4.4||||||At risk subjects.||4.4|0.45|
71104174|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H1N1 strain)|3.67|||||TWO_SIDED|95.0|2.97|4.54||||||No risk subjects.||4.54|2.97|
71104175|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H3N2 strain)|2.78|||||TWO_SIDED|95.0|2.29|3.37||||||No risk subjects.||3.37|2.29|
70928866|NCT05170841|141353139|SUPERIORITY||||||=|0.045|||||||t-test, 2 sided|||||||=0.045
70928867|NCT05170841|141353140|SUPERIORITY||||||=|0.029|||||||t-test, 2 sided|||||||=0.029
70928868|NCT05170841|141353141|SUPERIORITY||||||=|0.027|||||||t-test, 2 sided|||||||=0.027
70928869|NCT05170841|141353142|SUPERIORITY||||||=|0.035|||||||t-test, 2 sided|||||||=0.035
70928870|NCT05170841|141353143|SUPERIORITY||||||=|0.001|||||||t-test, 2 sided|||||||=0.001
71013673|NCT02777554|141534070|OTHER||Ratio (%) of Geometric Means|103.9|||||TWO_SIDED|90.0|93.6|115.4|||||Geometric mean ratio (Apremilast 75 mg XL / Apremilast 30 mg IR BID) from an ANOVA model, expressed as a percentage.|To estimate the exposure of apremilast following single dose administration of extended release (QD) relative to the Reference IR (BID) tablet under fasted conditions, an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax of apremilast.||115.4|93.6|
71013674|NCT02777554|141534070|OTHER||Ratio (%) of Geometric Means|90.9|||||TWO_SIDED|90.0|81.6|101.3|||||Geometric mean ratio (Apremilast 75 mg XL (Fasted) / Apremilast 75 mg XL (Standard Meal)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax of apremilast.||101.3|81.6|
71013675|NCT02777554|141534070|OTHER||Ratio (%) of Geometric Means|115.0|||||TWO_SIDED|90.0|103.3|128.1|||||Geometric mean ratio (Apremilast 75 mg XL (High Fat) / Apremilast 75 mg XL (Standard Meal)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax of apremilast.||128.1|103.3|
71013676|NCT02777554|141534070|OTHER||Ratio (%) of Geometric Means|126.5|||||TWO_SIDED|90.0|113.7|140.8|||||Geometric mean ratio (Apremilast 75 mg XL (High Fat) / Apremilast 75 mg XL (Fasted)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax of apremilast.||140.8|113.7|
71047987|NCT00292188|141605091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.72|STANDARD_ERROR_OF_MEAN|2.62||0||95.0|-15.89|-5.55|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Sleep Disturbance||-5.55|-15.89|0.000
70928871|NCT03806790|141353145|SUPERIORITY||Odds Ratio (OR)|5.8||||0.12|TWO_SIDED|95.0|0.68|49.16|||Fisher Exact|||Statistical analysis on the Full Analysis Set (FAS)||49.16|0.68|0.120
70928872|NCT03806790|141353146|SUPERIORITY||Odds Ratio (OR)|2.5||||0.004|TWO_SIDED|95.0|1.36|4.6|||Fisher Exact|||End of Week 1 (FAS)||4.60|1.36|0.004
70928873|NCT03806790|141353146|SUPERIORITY||Odds Ratio (OR)|4.85||||0.003|TWO_SIDED|95.0|1.57|14.97|||Fisher Exact|||End of Week 2 (FAS)||14.97|1.57|0.003
71029179|NCT03130699|141565909|SUPERIORITY|||||||0.11|||||||Regression, Logistic|||Binary logistic regression analyses were conducted for this outcome. Unstandardized regression coefficients represent logit coefficients.||||0.11
71029180|NCT03130699|141565910|SUPERIORITY|||||||0.76|||||||Regression, Logistic|||Analyses controlled for income.||||0.76
71029181|NCT03130699|141565911|SUPERIORITY|||||||0.05|||||||Regression, Logistic|||Analyses controlled for income.||||0.05
71029182|NCT03130699|141565912|SUPERIORITY|||||||0.63|||||||Regression, Logistic|||Analyses controlled for income.||||0.63
71029183|NCT03130699|141565913|SUPERIORITY|||||||0.63|||||||Regression, Logistic|||Analyses is controlled for income.||||0.63
71029184|NCT03130699|141565914|SUPERIORITY|||||||0.002|||||||Regression, Logistic|||Analyses controlled for income.||||0.002
71029185|NCT03130699|141565915|SUPERIORITY|||||||0.008|||||||Regression, Logistic|||Analyses controlled for income.||||0.008
71029186|NCT01199861|141565920|SUPERIORITY_OR_OTHER||Percent Inhibition|41.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the A/California/7/09 (H1N1) strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo three weeks after a single dose of seasonal influenza vaccine.||||
71029187|NCT01199861|141565920|SUPERIORITY_OR_OTHER||Percent Inhibition|-35.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the A/Perth/16/2009 (H3N2) strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo three weeks after a single dose of seasonal influenza vaccine.||||
70928874|NCT03806790|141353147|SUPERIORITY||Estimated difference|-1.11|||<|0.001|TWO_SIDED|95.0|-1.64|-0.59|||ANOVA|||FAS||-0.59|-1.64|<0.001
70928875|NCT04865289|141353153|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.51|1.41||||||||1.41|0.51|
70928876|NCT04865289|141353154|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.48|1.21||||||||1.21|0.48|
70928877|NCT04865289|141353155|NON_INFERIORITY|The null hypothesis for the non-inferiority test was that the hazard ratio was equal to 1.1.|Hazard Ratio (HR)|1.17||||0.5831415|TWO_SIDED|95.0|0.64|2.15|||Log Rank|One-sided p-value based on log-rank test.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate.|||2.15|0.64|0.5831415
70928878|NCT04865289|141353155|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.6980186|TWO_SIDED|95.0|0.64|1.26|||Log Rank|One-sided p-value based on log-rank test.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate.|||1.26|0.64|0.6980186
70928879|NCT04865289|141353156|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.52046|TWO_SIDED|95.0|0.57|1.8|||Log Rank|One-sided p-value based on log-rank test.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate.|||1.80|0.57|0.52046
70941523|NCT05244226|141383804|SUPERIORITY|||||||0.023|||||||Kruskal-Wallis|Dunn's Kruskal Wallis with Bonferroni correction||||||0.023
70928880|NCT04865289|141353157|OTHER||Difference in Percentage|-10.5||||0.8497|TWO_SIDED|95.0|-29.2|9.3|||Miettinen & Nurminen|One sided p value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.||||9.3|-29.2|0.8497
70928881|NCT04865289|141353158|OTHER||Difference in Percentage|-9.1||||0.8522|TWO_SIDED|95.0|-25.5|8.0|||Miettinen & Nurminen|One sided p value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.||||8.0|-25.5|0.8522
70928882|NCT04865289|141353159|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction.|Difference in Least Square Means|-2.14||||0.6138|TWO_SIDED|95.0|-10.54|6.27|||cLDA model|||||6.27|-10.54|0.6138
71104176|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (B strain)|4.01|||||TWO_SIDED|95.0|3.46|4.65||||||No risk subjects.||4.65|3.46|
71104177|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H1N1 strain)|1.4|||||TWO_SIDED|95.0|0.45|4.4||||||At risk subjects.||4.4|0.45|
71104178|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|4.32|||||TWO_SIDED|95.0|1.43|13.0||||||At risk subjects.||13|1.43|
71104179|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.69|||||TWO_SIDED|95.0|1.67|8.15||||||At risk subjects.||8.15|1.67|
71104180|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.35|||||TWO_SIDED|95.0|0.89|2.04||||||No risk subjects.||2.04|0.89|
71104181|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.59|||||TWO_SIDED|95.0|1.14|2.22||||||No risk subjects.||2.22|1.14|
71104182|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.68|||||TWO_SIDED|95.0|1.3|2.15||||||No risk subjects.||2.15|1.3|
70928883|NCT04865289|141353160|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction.|Difference in Least Square Means|-0.73||||0.8398|TWO_SIDED|95.0|-7.93|6.46|||cLDA model|||||6.46|-7.93|0.8398
70928884|NCT04707469|141353206|SUPERIORITY|Change from baseline was analyzed using an ANCOVA model with treatment, strata and region as categorical fixed effects and baseline value as covariate for each of the 1000 imputed complete datasets,and pooled by Rubin's rule to draw inference.|Treatment difference|-0.27||||0.0006|TWO_SIDED|95.0|-0.42|-0.12||Unadjusted two-sided p-value for test of no difference.|ANCOVA|||Treatment policy estimand||-0.12|-0.42|0.0006
70850423|NCT01057589|141188594|SUPERIORITY_OR_OTHER|||||||0.697||||||P-value is for Change at End of Triplet Combination Therapy. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.697
70928885|NCT04707469|141353206|SUPERIORITY|Change from baseline was analyzed using an ANCOVA model with treatment, strata and region as categorical fixed effects and baseline value as covariate for each of the 1000 imputed complete datasets,and pooled by Rubin's rule to draw inference.|Treatment difference|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.68|-0.38||Unadjusted two-sided p-value for test of no difference.|ANCOVA|||Treatment policy estimand||-0.38|-0.68|<.0001
70928886|NCT06122194|141353267|OTHER||Ratio of Adjusted Geometric Means|112.15|||||TWO_SIDED|90.0|93.01|135.22||||||Natural log transformed Cmax for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90 percent (%) confidence intervals (CIs) were expressed as percentages.||135.22|93.01|
71104183|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.73|||||TWO_SIDED|95.0|0.29|10.0||||||At risk subjects.||10|0.29|
71104184|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.16|||||TWO_SIDED|95.0|0.33|4.01||||||At risk subjects.||4.01|0.33|
71104185|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.45|||||TWO_SIDED|95.0|0.53|3.94||||||At risk subjects.||3.94|0.53|
71104186|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.24|||||TWO_SIDED|95.0|1.48|3.39||||||No risk subjects||3.39|1.48|
70928887|NCT06122194|141353267|OTHER||Ratio of Adjusted Geometric Means|187.37|||||TWO_SIDED|90.0|155.79|225.35||||||Natural log transformed Cmax for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90% CIs were expressed as percentages.||225.35|155.79|
70928888|NCT06122194|141353267|OTHER||Ratio of Adjusted Geometric Means|153.61|||||TWO_SIDED|90.0|127.4|185.21||||||Natural log transformed Cmax for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90% CIs were expressed as percentages.||185.21|127.40|
70928889|NCT06122194|141353268|OTHER||Ratio of Adjusted Geometric Means|102.59|||||TWO_SIDED|90.0|91.09|115.54||||||Natural log transformed AUCinf for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90% CIs were expressed as percentages.||115.54|91.09|
70928890|NCT06122194|141353268|OTHER||Ratio of Adjusted Geometric Means|125.07|||||TWO_SIDED|90.0|110.81|141.17||||||Natural log transformed AUCinf for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90% CIs were expressed as percentages.||141.17|110.81|
70928891|NCT06122194|141353268|OTHER||Ratio of Adjusted Geometric Means|121.75|||||TWO_SIDED|90.0|108.65|136.43||||||Natural log transformed AUCinf for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90% CIs were expressed as percentages.||136.43|108.65|
70928892|NCT02724969|141353278|SUPERIORITY|||||||0.272|||||||Mixed Models Analysis|||||||.272
70928893|NCT02724969|141353279|SUPERIORITY|||||||0.082|||||||Mixed Models Analysis|||||||.082
70928894|NCT02724969|141353280|SUPERIORITY|||||||0.355|||||||Mixed Models Analysis|||||||.355
70928895|NCT02724969|141353281|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|||||||.780
71013677|NCT02777554|141534071|OTHER||Ratio (%) of Geometric Means|92.9|||||TWO_SIDED|90.0|81.3|106.2|||||Geometric mean ratio (Apremilast 75 mg XL / Apremilast 30 mg IR BID) from an ANOVA model, expressed as a percentage.|To estimate the exposure of apremilast following single dose administration of extended release (QD) relative to the Reference IR (BID) tablet under fasted conditions, an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t of apremilast.||106.2|81.3|
71104187|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.76|||||TWO_SIDED|95.0|1.26|2.46||||||No risk subjects.||2.46|1.26|
71104188|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.59|||||TWO_SIDED|95.0|1.24|2.04||||||No risk subjects||2.04|1.24|
71104189|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.48|||||TWO_SIDED|95.0|0.34|18.0||||||At risk subjects.||18|0.34|
71104190|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.98|||||TWO_SIDED|95.0|0.49|7.92||||||At risk subjects.||7.92|0.49|
71104191|NCT01346592|141715391|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|0.71|||||TWO_SIDED|95.0|0.23|2.16||||||At risk subjects.||2.16|0.23|
70928896|NCT02724969|141353282|SUPERIORITY|||||||0.588|||||||Mixed Models Analysis|||||||.588
70928897|NCT03916185|141353306|SUPERIORITY||Difference in proportions|0.0|||>|0.99|TWO_SIDED|95.0|-32.0|32.0||Statistical significance level of 0.05 was used. No adjustment for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||32|-32|>0.99
70928898|NCT03916185|141353306|SUPERIORITY||Difference in proportions|-15.0||||0.53|TWO_SIDED|95.0|-46.0|18.0||Statistical significance level of 0.05 used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||18|-46|0.53
70928899|NCT03916185|141353306|SUPERIORITY||Difference in proportions|16.0||||0.66|TWO_SIDED|95.0|-29.0|52.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||52|-29|0.66
70928900|NCT03916185|141353307|SUPERIORITY||Difference in proportions|0.0|||>|0.99|TWO_SIDED|95.0|-20.0|20.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||20|-20|>0.99
70928901|NCT03916185|141353307|SUPERIORITY||Difference in proportions|-5.0|||>|0.99|TWO_SIDED|95.0|-25.0|13.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||13|-25|>0.99
70928902|NCT03916185|141353307|SUPERIORITY||Difference in proportions|-5.0|||>|0.99|TWO_SIDED|95.0|-26.0|34.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||34|-26|>0.99
70928903|NCT03916185|141353308|SUPERIORITY||Difference in proportions|0.0|||>|0.99|TWO_SIDED|95.0|-18.0|18.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||18|-18|>0.99
70928904|NCT03916185|141353308|SUPERIORITY||Difference in proportions|0.0|||>|0.99|TWO_SIDED|95.0|-18.0|18.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||18|-18|>0.99
70928905|NCT03916185|141353308|SUPERIORITY||Difference in proportions|0.0|||>|0.99|TWO_SIDED|95.0|-17.0|41.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||41|-17|>0.99
70928906|NCT03916185|141353309|SUPERIORITY||Difference in proportions|61.0|||<|0.001|TWO_SIDED|95.0|27.0|83.0||Statistical significance level of 0.05 was used. No adjustment for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||83|27|<0.001
70928907|NCT03916185|141353309|SUPERIORITY||Difference in proportions|56.0|||<|0.001|TWO_SIDED|95.0|22.0|79.0|||Fisher Exact|Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Comparison was vaccine arm - placebo.|||79|22|<0.001
70928908|NCT03916185|141353309|SUPERIORITY||Difference in proportions|56.0||||0.011|TWO_SIDED|95.0|9.0|86.0|||Fisher Exact|Statistical significance level of 0.05 was used. No adjustments were made for multiple comparisons.|Comparison was vaccine arm - placebo.|||86|9|0.011
70928909|NCT03916185|141353309|SUPERIORITY||Difference in proportions|6.0|||>|0.99|TWO_SIDED|95.0|-25.0|36.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was RSV ΔNS2/Δ1313/I1314L Vaccine - RSV 6120/ΔNS2/1030s Vaccine.|||36|-25|>0.99
70928910|NCT03916185|141353309|SUPERIORITY||Difference in proportions|5.0|||>|0.99|TWO_SIDED|95.0|-31.0|48.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was RSV ΔNS2/Δ1313/I1314L Vaccine - RSV 276 Vaccine.|||48|-31|>0.99
70928911|NCT03916185|141353309|SUPERIORITY||Difference in proportions|-1.0|||>|0.99|TWO_SIDED|95.0|-38.0|44.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was RSV 6120/ΔNS2/1030s Vaccine - RSV 276 Vaccine.|||44|-38|>0.99
70928912|NCT03916185|141353310|SUPERIORITY||Difference in proportions|73.0|||<|0.001|TWO_SIDED|95.0|44.0|91.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||91|44|<0.001
70928913|NCT03916185|141353310|SUPERIORITY||Difference in proportions|61.0|||<|0.001|TWO_SIDED|95.0|27.0|83.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||83|27|<0.001
70928914|NCT03916185|141353310|SUPERIORITY||Difference in proportions|85.0|||<|0.001|TWO_SIDED|95.0|42.0|97.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||97|42|<0.001
70928915|NCT03916185|141353310|SUPERIORITY||Difference in proportions|12.0||||0.66|TWO_SIDED|95.0|-17.0|40.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was RSV ΔNS2/Δ1313/I1314L Vaccine - RSV 6120/ΔNS2/1030s Vaccine.|||40|-17|0.66
70928916|NCT03916185|141353310|SUPERIORITY||Difference in proportions|-12.0|||>|0.99|TWO_SIDED|95.0|-36.0|30.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was RSV ΔNS2/Δ1313/I1314L Vaccine - RSV 276 Vaccine.|||30|-36|>0.99
71047988|NCT00292188|141605091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.05|STANDARD_ERROR_OF_MEAN|2.71||0.7||95.0|-4.3|6.4|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Snoring||6.40|-4.30|0.700
70928917|NCT03916185|141353310|SUPERIORITY||Difference in proportions|-24.0||||0.28|TWO_SIDED|95.0|-50.0|20.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was RSV 6120/ΔNS2/1030s Vaccine - RSV 276 Vaccine.|||20|-50|0.28
70928918|NCT03916185|141353311|SUPERIORITY||||||<|0.001||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
70928919|NCT03916185|141353311|SUPERIORITY||||||<|0.001||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
70928920|NCT03916185|141353311|SUPERIORITY||||||<|0.001||||||Statistical significance of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
70928921|NCT03916185|141353311|SUPERIORITY|||||||0.95||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.95
70928922|NCT03916185|141353311|SUPERIORITY|||||||0.12||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.12
70928923|NCT03916185|141353311|SUPERIORITY|||||||0.033||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.033
70928924|NCT03916185|141353312|SUPERIORITY||||||<|0.001||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
70928925|NCT03916185|141353312|SUPERIORITY||||||<|0.001||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
70928926|NCT03916185|141353312|SUPERIORITY||||||<|0.001||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
70928927|NCT03916185|141353312|SUPERIORITY|||||||0.39||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.39
70928928|NCT03916185|141353312|SUPERIORITY|||||||0.15||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.15
70928929|NCT03916185|141353312|SUPERIORITY|||||||0.049||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.049
70928930|NCT05312008|141353325|SUPERIORITY||||||<|0.6|||||||t-test, 2 sided|paired||||||<0.6
70928931|NCT05312008|141353326|SUPERIORITY||||||<|0.6|||||||t-test, 2 sided|Paired||||||<0.6
71047989|NCT00292188|141605091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.95|STANDARD_ERROR_OF_MEAN|2.88||0.04||95.0|-11.62|-0.28|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Awaken Short of Breath/Headache||-0.28|-11.62|0.040
71047990|NCT00292188|141605091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.42||0.846||95.0|-0.92|0.76|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Sleep Quantity||0.76|-0.92|0.846
71047991|NCT00292188|141605091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.63|STANDARD_ERROR_OF_MEAN|3.27||0.001||95.0|4.19|17.07|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Sleep Adequacy||17.07|4.19|0.001
71047992|NCT00292188|141605091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.31|STANDARD_ERROR_OF_MEAN|2.34||0.324||95.0|-2.3|6.92|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Somnolence||6.92|-2.30|0.324
71047993|NCT00292188|141605091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.52|STANDARD_ERROR_OF_MEAN|2.63||0||95.0|-14.71|-4.33|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Sleep Problems Index-6||-4.33|-14.71|0.000
70850424|NCT01057589|141188594|SUPERIORITY_OR_OTHER|||||||0.132||||||P-value is for Change at End of Maintenance Therapy. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.132
70850425|NCT01057589|141188595|SUPERIORITY_OR_OTHER|||||||0.223||||||P-value is for Change at End of Triplet Combination Therapy. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.223
70850426|NCT01057589|141188595|SUPERIORITY_OR_OTHER|||||||0.788||||||P-value is for Change at End of Maintenance Therapy. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.788
70850427|NCT01057589|141188596|SUPERIORITY_OR_OTHER|||||||0.9||||||P-value is for NOD, Triplicate Combination Therapy Cycle 2. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.90
70850428|NCT01057589|141188596|SUPERIORITY_OR_OTHER|||||||0.31||||||P-value is for NOD, Triplicate Combination Therapy Cycle 4. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.31
70850429|NCT01057589|141188596|SUPERIORITY_OR_OTHER|||||||0.49||||||P-value is for NOD, Triplicate Combination Therapy Cycle 6. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.49
70850430|NCT01057589|141188596|SUPERIORITY_OR_OTHER|||||||0.95||||||P-value is for NOD, Maintenance Cycle 1. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.95
70850431|NCT01057589|141188596|SUPERIORITY_OR_OTHER|||||||0.89||||||P-value is for NOD, Maintenance Cycle 3. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.89
70850432|NCT01057589|141188596|SUPERIORITY_OR_OTHER|||||||0.36||||||P-value is for NOD, Maintenance Cycle 5. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.36
70928932|NCT05312008|141353327|SUPERIORITY||||||<|1|||||||t-test, 2 sided|Paired||||||<1
70928933|NCT05312008|141353328|SUPERIORITY||||||<|0.04|||||||t-test, 2 sided|Paired||||||<0.04
70928934|NCT05312008|141353329|SUPERIORITY||||||<|0.5|||||||t-test, 2 sided|Paired||||||<0.5
70928935|NCT03738852|141353347|SUPERIORITY|||||||0.907|||||||ANOVA|||||||0.907
70928936|NCT02010242|141353409|SUPERIORITY|All statistical analyses were performed on a comparison-wise basis without adjustment for multiple comparisons.||||||1|||||||ANCOVA|||Primary efficacy endpoint was analyzed using ANCOVA comparing GKT137831 vs placebo after controlling for the baseline UACR level. The UACR were log-transformed prior to analysis. The model included treatment group and log-transformed baseline UACR value as predicted variables. The results were back-transformed exponentially to calculate geo. mean values and associated 90% CIs and 1-sided p-values. The null hypothesis was that the difference in the adjusted mean logarithm of UACR was equal to 0||||1.000
70928937|NCT04731129|141353426|SUPERIORITY|||||||0.023||||||threshold for statistical significance \< 0.05|Fisher Exact|||Abnormal tissular architecture||||0.023
70928938|NCT04731129|141353426|SUPERIORITY|||||||0.01||||||Threshold for statistical significance \< 0.05|Fisher Exact|||Homogeneous cell size||||0.01
70928939|NCT04731129|141353426|SUPERIORITY|||||||0.01||||||threshold for statistical significance \< 0.05|Fisher Exact|||Homogeneous cell shape||||0.01
70928940|NCT04731129|141353426|SUPERIORITY|||||||0.013||||||threshold for statistical significance \< 0.05|Fisher Exact|||Homogeneous cell fluorescence||||0.013
70928941|NCT04731129|141353426|SUPERIORITY|||||||0.16||||||threshold for statistical significance \< 0.05|Fisher Exact|||Blood vessel dysplasia||||0.16
70928942|NCT04731129|141353426|SUPERIORITY|||||||0.17||||||threshold for statistical significance \< 0.05|Fisher Exact|||Organized conjunctive fibers||||0.17
70928943|NCT04731129|141353426|SUPERIORITY|||||||0.049||||||threshold for statistical significance \< 0.05|Fisher Exact|||Full chia seed sign||||0.049
71047994|NCT00292188|141605091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.54|STANDARD_ERROR_OF_MEAN|2.02||0||95.0|-11.52|-3.56|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Sleep Problems Index-9||-3.56|-11.52|0.000
70850433|NCT01057589|141188596|SUPERIORITY_OR_OTHER|||||||0.18||||||P-value is for NOD, Maintenance Cycle 7. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.18
70928944|NCT04731129|141353426|SUPERIORITY|||||||0.0041||||||threshold for statistical significance \< 0.05|Fisher Exact|||General physician conclusion||||0.0041
70928945|NCT03386578|141353438|OTHER||Incidence rate ratio|1.62|||||TWO_SIDED|95.0|0.89|2.94||||||The incidence rate ratio of cumulative maternal adverse events was calculated between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and the PrEP-unexposed (Cohort 2/Step 1) reference group based on incidence per person-time follow-up. Maternal participants in Cohort 2/Step 2 contributed person-time to both Cohort 2/Step 1 and Step 2.||2.94|0.89|
70928946|NCT03386578|141353439|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.52|1.5||||||Odds ratio comparing the proportion of mothers with adverse pregnancy outcomes between the PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed (Cohort 2/Step 1) reference group.||1.50|0.52|
70928947|NCT03386578|141353439|OTHER|||||||0.68|||||||Fisher Exact|||Test the differences in the proportion of mothers with adverse pregnancy outcomes between PrEP-exposed (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed (Cohort 2/Step 2) groups.||||0.68
70928948|NCT03386578|141353440|OTHER||Incidence rate ratio|1.29|||||TWO_SIDED|95.0|0.7|2.38||||||The incidence rate ratio of cumulative infant AEs between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed (Cohort 2/Step 1) reference group was based on incidence per person-time follow-up. Cohort 2/Step 2 infants contributed person-time to both Cohort 2/Step 1 and Step 2.||2.38|0.70|
70928949|NCT03386578|141353441|OTHER|||||||0.18|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant whole-body bone mineral content (WB-BMC) at birth between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.18
70928950|NCT03386578|141353442|OTHER|||||||0.39|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant lumbar-spine bone mineral content (WB-BMC) at birth between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.39
70928951|NCT03386578|141353443|OTHER|||||||0.12|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant lumbar-spine bone mineral content (WB-BMC) at week 26 between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.12
70928952|NCT03386578|141353444|OTHER|||||||0.7|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant creatinine levels at birth between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.70
70928953|NCT03386578|141353445|OTHER|||||||0.58|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant creatinine levels at week 26 between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.58
70928954|NCT03386578|141353446|OTHER|||||||0.08|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant creatinine clearance rate at birth between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.08
70928955|NCT03386578|141353447|OTHER|||||||0.52|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant creatinine clearance rate at week 26 between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1)||||0.52
70928956|NCT03386578|141353448|OTHER|||||||0.3|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant length-for-age z-score at birth between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.30
70928957|NCT03386578|141353449|OTHER|||||||0.06|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant length-for-age z-score at week 26 between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.06
70928958|NCT03386578|141353450|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
70928959|NCT05907174|141353451|SUPERIORITY||B|-2.23||||0.023|TWO_SIDED||||||Regression, Linear|||||||0.023
70928960|NCT03916276|141353457|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce a greater proportion of people decreasing their dose relative to those increasing their dose during treatment.|||||>|0.05|||||||Chi-squared|||||||>.05
70928961|NCT03916276|141353458|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
70850434|NCT01057589|141188596|SUPERIORITY_OR_OTHER|||||||0.47||||||P-value is for EIP, Triplicate Combination Cycle 2. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.47
70850435|NCT01057589|141188596|SUPERIORITY_OR_OTHER|||||||0.17||||||P-value is for EIP, Triplicate Combination Cycle 4. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.17
70928962|NCT03916276|141353459|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
70928963|NCT03916276|141353460|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
70928964|NCT03916276|141353461|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
70928965|NCT03916276|141353462|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
70928966|NCT03916276|141353463|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
70928967|NCT03916276|141353464|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
70928968|NCT03916276|141353465|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
71047995|NCT00292188|141605092|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.42||||0.267||95.0|0.76|2.64|||Regression, Logistic|Logistic regression adjusted for treatment group, baseline score and pooled country.||||2.64|0.76|0.267
71047996|NCT00292188|141605100|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.84|STANDARD_ERROR_OF_MEAN|2.25||0.09||95.0|-8.28|0.61|||ANCOVA|||||0.61|-8.28|0.090
70928969|NCT03916276|141353466|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||<|0.05|||||||ANOVA|||||||<.05
70928970|NCT03916276|141353467|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements|||||>|0.05|||||||ANOVA|||||||>.05
70928971|NCT03916276|141353468|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements|||||>|0.05|||||||ANOVA|||||||>.05
70928972|NCT03916276|141353469|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
70928973|NCT03916276|141353470|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
70928974|NCT03916276|141353471|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
70928975|NCT03916276|141353472|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
70928976|NCT03916276|141353473|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
70928977|NCT02668692|141353474|SUPERIORITY||Odds Ratio (OR)|1.96|||=|0.68|TWO_SIDED|95.0|0.35|10.95|||Fisher Exact|||Statistical analysis of the FAS.||10.95|0.35|=0.68
70928978|NCT02668692|141353474|SUPERIORITY||Odds Ratio (OR)|1.92|||=|0.68|TWO_SIDED|95.0|0.34|10.72||Treatment comparison by Fisher's exact test.|Fisher Exact||Odds of 'overall improvement' in LEO 80185 gel group relative to Dovobet® ointment group.|Statistical analysis of the PPAS.||10.72|0.34|=0.68
70941524|NCT05244226|141383808|SUPERIORITY|||||||0.144|||||||Kruskal-Wallis|||||||0.144
71047997|NCT00824616|141605110|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.745|TWO_SIDED|95.0|-0.81|0.58|||Longitudinal Data Analysis (LDA) model|||||0.58|-0.81|0.745
71047998|NCT00824616|141605111|SUPERIORITY_OR_OTHER||Proportions|5.9||||0.537|TWO_SIDED|95.0|-13.7|25.4|||Miettinen & Nurminen method|||Between-treatment difference (MK-0941 group minus Placebo group) in the percentage of participants who experienced one or more episodes of hypoglycemia.||25.4|-13.7|0.537
71047999|NCT01796912|141605112|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
71048000|NCT01796912|141605113|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71048001|NCT01796912|141605114|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
71048002|NCT01796912|141605115|SUPERIORITY|||||||0.016|||||||t-test, 2 sided|||||||0.016
71048003|NCT01796912|141605116|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71048004|NCT01796912|141605117|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71048005|NCT01796912|141605118|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
71048006|NCT02920918|141605132|SUPERIORITY|||||||0.083|||||||ANOVA|||We expected a baseline peak oxygen consumption (VO2) of 14.5 mL/kg/min. A sample size of 40 patients per group (total of 80 patients) provided sufficient power to detect a mean difference in the interval change in peak VO2 of 1.50±1.76 mL/kg/min (primary endpoint) expected with Canagliflozin compared to Sitagliptin, which we predict to have no significant effect on peak VO2 (0±1.76 mL/kg/min).||||0.083
71048007|NCT02920918|141605133|SUPERIORITY|||||||0.51|||||||ANOVA|||||||0.51
71048008|NCT00974974|141605134|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<.0001
71048009|NCT00974974|141605135|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<.0001
70928979|NCT02668692|141353475|SUPERIORITY||Odds Ratio (OR)|0.28|||=|0.009|TWO_SIDED|95.0|0.11|0.74|||Fisher Exact|||Statistical analysis for the FAS.||0.74|0.11|=0.009
70928980|NCT02668692|141353475|SUPERIORITY||Odds Ratio (OR)|0.22|||=|0.003|TWO_SIDED|95.0|0.08|0.63||Treatment comparison by Fisher's exact test.|Fisher Exact||Odds of 'overall improvement' in LEO 80185 gel group relative to Dovobet® ointment group.|Statistical analysis of the PPAS.||0.63|0.08|=0.003
70928981|NCT01627574|141353494|SUPERIORITY||Risk Ratio, log|0.281|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED|95.0|0.056|1.42|||Chi-squared, Corrected|||||1.42|.056|>.05
70928982|NCT05233800|141353501|SUPERIORITY||Mean Difference (Net)|5.83|||<|0.05|TWO_SIDED|95.0|3.84|7.81|||Mixed Models Analysis|||||7.81|3.84|<0.05
70928983|NCT02432261|141353549|SUPERIORITY|We did not statistically power this study.|difference of proportion of subjects|57.6||||0.003|TWO_SIDED||||||Fisher Exact||The difference of proportion = NES/Testosterone - Testosterone|||||0.003
70928984|NCT04726371|141353623|SUPERIORITY|||||||0.89||||||A Wald test was used to test against the null hypothesis that intervention main effect and interaction effects between intervention and time trends were simultaneously zero and assess for differences in the mean trend of infections over follow-up.|Test of joint null hypothesis from model|Bonferroni-adjusted p-value is reported to correct for multiplicity for testing outcomes with 6 combinations of outcomes and subpopulations.||A Poisson GLMM was fit with a main effect for intervention group, linear and quadratic time trends, and interaction effects between intervention and the time trend variables. The model was adjust for stratification factors, baseline infection incidence, agency and included random intercept for group home.|"The point estimates for intervention main effect, intervention by linear time effect, and for intervention by time\^2 interaction effect are described in the paper Tailored vs. General COVID-19 prevention for adults with mental disabilities residing in group homes: a randomized controlled effectiveness-implementation trial by Bartels S, Levison JH, Trieu HD, et al., published in 2024 in BMC Public Health, doi:10.1186/s12889-024-18835-w."|||0.89
70928985|NCT04726371|141353624|SUPERIORITY||||||>|0.99||||||A Wald test was used to test against the null hypothesis that intervention main effect and interaction effects between intervention and time trends were simultaneously zero and assess for differences in the mean trend of scores over follow-up.|Wald test|Bonferroni-adjusted p-value is reported to correct for multiplicity for testing outcomes with 6 combinations of outcomes and subpopulations.||A GLMM was fit with a main effect for intervention group, linear and quadratic time trends, and interaction effects between intervention and the time trend variables. The model was adjust for stratification factors, baseline fidelity score, agency and included random intercept for group home.|"The point estimates for intervention main effect, intervention by linear time effect, and intervention by time\^2 interaction effect are described in the paper Tailored vs. General COVID-19 prevention for adults with mental disabilities residing in group homes: a randomized controlled effectiveness-implementation trial by Bartels S, Levison JH, Trieu HD, et al., published in 2024 in BMC Public Health, doi:10.1186/s12889-024-18835-w."|||>.99
70928986|NCT04726371|141353625|SUPERIORITY||Hazard Ratio (HR)|1.21|||>|0.99|TWO_SIDED|95.0|0.79|1.84||Bonferroni-adjusted p-value is reported to correct for multiplicity for testing outcomes with 6 combinations of outcomes and subpopulations.|Regression, Cox|||A Cox frailty model was fit to evaluate differences in the hazard of vaccination uptake between arms separately within the combined population of residents with SMI and ID/DD. This model included a main effect for intervention arm and additionally adjusted for stratification factors, GH agency, and GH-level log-normal frailties.||1.84|0.79|>.99
70928987|NCT04726371|141353626|SUPERIORITY||Hazard Ratio (HR)|0.99|||>|0.99|TWO_SIDED|95.0|0.86|1.15||Bonferroni-adjusted p-value is reported to correct for multiplicity for testing outcomes with 6 combinations of outcomes and subpopulations.|Regression, Cox|||A Cox frailty model was fit to evaluate differences in the hazard of vaccination uptake between arms separately within the staff population. This model included a main effect for intervention arm and additionally adjusted for stratification factors, GH agency, and GH-level log-normal frailties.||1.15|0.86|>.99
70928988|NCT02800356|141353683|OTHER|||||||0.404|||||||ANOVA|Analysis of Variance (ANOVA) for paired samples with Bonferroni post-hoc analysis||||||0.404
70928989|NCT02800356|141353684|OTHER|||||||0.232|||||||ANOVA|Analysis of Variance (ANOVA) for paired samples with Bonferroni post-hoc analysis||||||0.232
70928990|NCT02800356|141353685|OTHER|||||||0.001|||||||ANOVA|Analysis of Variance (ANOVA) for paired samples with Bonferroni post-hoc analysis||||||0.001
70928991|NCT02800356|141353688|OTHER|||||||0.267|||||||ANOVA|Analysis of Variance (ANOVA) for paired samples with Bonferroni post-hoc analysis||||||0.267
70928992|NCT05623228|141353699|SUPERIORITY|||||||0||||||"Bonferroni correction p\<.05~F(1.25)=9.17 η=.254 (p\<.05)"|ANOVA|||||||.00
70928993|NCT05623228|141353699|SUPERIORITY|||||||0||||||Bonferroni correction p\<.05 F(2)=7.30 η=.213 (P\<.05)|ANOVA|||||||.00
70928994|NCT05623228|141353700|SUPERIORITY|||||||0.04||||||F(2)=3.20, η=.106 Bonferroni Correction p\<.05|ANOVA|||||||.04
70928995|NCT05623228|141353701|SUPERIORITY|||||||0||||||F(1,06)=8,11, η2=.231 Bonferroni correction p\<.05|ANOVA|||||||.00
70928996|NCT05623228|141353702|SUPERIORITY|||||||0.04||||||F(1,19)=4,30, η2=.137 Bonferroni correction p\<0.5|ANOVA|||||||.04
70928997|NCT05623228|141353703|SUPERIORITY|||||||0||||||t (38.70)|t-test, 1 sided|||||||.00
70928998|NCT04625725|141353723|SUPERIORITY||Relative Risk Reduction|76.73|||<|0.001|TWO_SIDED|95.0|46.05|89.96|||Poisson regression||Estimates are based on a Poisson regression with robust variance. The model includes covariate for treatment, and age group, with the log of the follow-up time as an offset. Estimated RRR greater than 0% provides evidence in favor of AZD7442.|Primary Analysis||89.96|46.05|<0.001
70928999|NCT04625725|141353723|SUPERIORITY||Relative Risk Reduction|83.04|||<|0.001|TWO_SIDED|95.0|67.26|91.21|||Poisson regression||Estimates are based on a Poisson regression with robust variance. The model includes covariate for treatment, and age group, with the log of the follow-up time as an offset. Estimated RRR greater than 0% provides evidence in favor of AZD7442.|Final Analysis||91.21|67.26|<0.001
70929000|NCT04625725|141353725|SUPERIORITY||Relative Risk Reduction|34.9|||<|0.001|TWO_SIDED|95.0|21.44|46.05|||Poisson regression||Estimates are based on a Poisson regression with robust variance. The model includes covariate for treatment, and age group, with the log of the follow-up time as an offset. Estimated RRR greater than 0% provides evidence in favor of AZD7442.|||46.05|21.44|<0.001
70941525|NCT05244226|141383808|SUPERIORITY|||||||0.322|||||||Kruskal-Wallis|||||||0.322
70941526|NCT05244226|141383809|SUPERIORITY|||||||0.061|||||||Kruskal-Wallis|Dunn's Kruskal Wallis with Bonferroni correction||||||0.061
71013678|NCT02777554|141534071|OTHER||Ratio (%) of Geometric Means|86.0|||||TWO_SIDED|90.0|74.9|98.7|||||Geometric mean ratio (Apremilast 75 mg XL (Fasted) / Apremilast 75 mg XL (Standard Meal)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t of apremilast.||98.7|74.9|
71013679|NCT02777554|141534071|OTHER||Ratio (%) of Geometric Means|97.3|||||TWO_SIDED|90.0|84.9|111.6|||||Geometric mean ratio (Apremilast 75 mg XL (High Fat) / Apremilast 75 mg XL (Standard Meal)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t of apremilast.||111.6|84.9|
71013680|NCT02777554|141534071|OTHER||Ratio (%) of Geometric Means|113.2|||||TWO_SIDED|90.0|98.8|129.7|||||Geometric mean ratio (Apremilast 75 mg XL (High Fat) / Apremilast 75 mg XL (Fasted)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t of apremilast.||129.7|98.8|
71013681|NCT02777554|141534072|OTHER||Ratio (%) of Geometric Means|92.6|||||TWO_SIDED|90.0|81.1|105.9|||||Geometric mean ratio (Apremilast 75 mg XL / Apremilast 30 mg IR BID) from an ANOVA model, expressed as a percentage.|To estimate the exposure of apremilast following single dose administration of extended release (QD) relative to the Reference IR (BID) tablet under fasted conditions, an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞ of apremilast.||105.9|81.1|
71013682|NCT02777554|141534072|OTHER||Ratio (%) of Geometric Means|86.1|||||TWO_SIDED|90.0|75.0|98.8|||||Geometric mean ratio (Apremilast 75 mg XL (Fasted) / Apremilast 75 mg XL (Standard Meal)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞ of apremilast.||98.8|75.0|
71013683|NCT02777554|141534072|OTHER||Ratio (%) of Geometric Means|97.5|||||TWO_SIDED|90.0|85.0|111.8|||||Geometric mean ratio (Apremilast 75 mg XL (High Fat) / Apremilast 75 mg XL (Standard Meal)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞ of apremilast.||111.8|85.0|
71013684|NCT02777554|141534072|OTHER||Ratio (%) of Geometric Means|113.2|||||TWO_SIDED|90.0|98.8|129.7|||||Geometric mean ratio (Apremilast 75 mg XL (High Fat) / Apremilast 75 mg XL (Fasted)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞ of apremilast.||129.7|98.8|
71013685|NCT01945034|141534104|SUPERIORITY_OR_OTHER||LS Mean Difference|23.0||||0.19|TWO_SIDED|95.0|-11.49|57.56||p-value \<=0.05 for treatment effects|ANOVA|||The analysis of variance (ANOVA) model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||57.56|-11.49|0.190
71013686|NCT01945034|141534104|SUPERIORITY_OR_OTHER||LS Mean Difference|7.8||||0.633|TWO_SIDED|95.0|-24.2|39.7||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||39.70|-24.20|0.633
71013687|NCT01945034|141534104|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.3||||0.436|TWO_SIDED|95.0|-53.87|23.3||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity on weight bearing terms.||23.30|-53.87|0.436
71013688|NCT01945034|141534105|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|4.8||||0.426|TWO_SIDED|95.0|-6.98|16.49||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating (BLPSR), pooled site blocks, and baseline pain intensity on weight bearing (BLPIWB) terms. 95% CI not includes 0 for treatment effect. Upper limit of 95% CI\< 0 for Ibuprofen treatment significantly better than combined Placebo. Comparison: tested at the 0.05 level of significance (2-sided). A comparison was eligible for being declared significant only if preceding comparison was significant.||16.49|-6.98|0.426
71048010|NCT00688376|141605172|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.8||||0.694|TWO_SIDED|95.0|-3.22|4.8|||ANCOVA|||P-values, least squares (LS) mean, and 95% confidence interval (CI) were obtained from Analysis of Covariance (ANCOVA) model with treatment group as a factor and Baseline value as covariate.||4.8|-3.22|0.694
71048011|NCT00688376|141605173|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.1||||0.9458|TWO_SIDED|95.0|-4.38|4.09|||ANCOVA|||P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||4.09|-4.38|0.9458
71048012|NCT00688376|141605174|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.4||||0.743|TWO_SIDED|95.0|-9.56|6.85|||ANCOVA|||RTVSS Change from Baseline to Week 6 (LOCF). P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||6.85|-9.56|0.743
71048013|NCT00688376|141605174|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.2||||0.9561|TWO_SIDED|95.0|-7.42|7.84|||ANCOVA|||RTVSS Change from Baseline to Week 12 (LOCF). P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||7.84|-7.42|0.9561
71048014|NCT00688376|141605174|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.5||||0.4385|TWO_SIDED|95.0|-3.97|9.04|||ANCOVA|||RTSS Change from Baseline to Week 6 (LOCF). P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||9.04|-3.97|0.4385
70929001|NCT04625725|141353726|SUPERIORITY||Relative Risk Reduction|91.41||||0.001|TWO_SIDED|95.0|61.31|98.09|||Poisson regression||Estimates are based on a Poisson regression with robust variance. The model includes covariate for treatment, and age group, with the log of the follow-up time as an offset. Estimated RRR greater than 0% provides evidence in favor of AZD7442.|||98.09|61.31|0.001
70929002|NCT04625725|141353727|SUPERIORITY||Relative Risk Reduction|52.43||||0.137|TWO_SIDED|95.0|-26.61|82.13|||Poisson regression|||||82.13|-26.61|0.137
70929003|NCT03298451|141353732|SUPERIORITY|||||||0.0035||||||The adjusted alpha levels (0.0398) for the two-sided superiority test were derived based upon the exact number of OS events for each comparison using the Lan and DeMets approach that approximates the O'Brien Fleming spending function.|Log Rank|||The analysis was performed using stratified log-rank test adjusting for treatment, etiology of liver disease (HBV versus HCV versus others), ECOG (0 versus 1), and macro-vascular invasion (yes versus no). The values of the stratification factors were obtained from IVRS.||||0.0035
70929004|NCT03298451|141353732|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.66|0.92|||Regression, Cox|||The analysis was performed using a Cox proportional hazards model adjusting for treatment, etiology of liver disease (HBV versus HCV versus others), ECOG (0 versus 1), and macro-vascular invasion (yes versus no). Values of the variables used for adjustment were obtained from IVRS.||0.92|0.66|
70929005|NCT03298451|141353733|NON_INFERIORITY|Non-interiority for the comparison of arm Durva 1500 mg vs Sora 400 mg is declared if the upper limit of the two-sided alpha adjusted CI for HR is less than the NI margin of 1.08.|Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.67|0.73|1.03|||Regression, Cox||The 95.67% confidence interval were derived based upon the exact number of OS events for each comparison using the Lan and DeMets approach that approximates the O'Brien Fleming spending function.|The analysis was performed using a Cox proportional hazards model adjusting for treatment, etiology of liver disease (HBV versus HCV versus others), ECOG (0 versus 1), and macro-vascular invasion (yes versus no). Values of the variables used for adjustment were obtained from IVRS.||1.03|0.73|
70929006|NCT03298451|141353733|SUPERIORITY|Superiority was tested sequentially per protocol as non-inferiority was satisfied.||||||0.0674||||||The adjusted alpha levels (0.0433) for the two-sided superiority test were derived based upon the exact number of OS events for each comparison using the Lan and DeMets approach that approximates the O'Brien Fleming spending function.|Log Rank|||The analysis was performed using stratified log-rank test adjusting for treatment, etiology of liver disease (HBV versus HCV versus others), ECOG (0 versus 1), and macro-vascular invasion (yes versus no). The values of the stratification factors were obtained from IVRS.||||0.0674
70929007|NCT01651403|141353751|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel test adjusted for age at baseline and region strata||||||< 0.001
71104192|NCT01346592|141715394|SUPERIORITY_OR_OTHER||GMT ratio (H1N1 strain)|4.07|||||TWO_SIDED|95.0|3.34|4.95||||||GMTs were considered to be statistically significantly higher if the lower bound of the 95% confidence interval around the vaccine group ratio was \>1.0||4.95|3.34|
71104193|NCT01346592|141715394|SUPERIORITY_OR_OTHER||GMT ratio (H3N2 strain)|1.95|||||TWO_SIDED|95.0|1.74|2.18||||||statistically significantly greater response was concluded if the lower bound of the 95% confidence interval around the vaccine group ratio is \>1.0||2.18|1.74|
71104194|NCT01346592|141715394|SUPERIORITY_OR_OTHER||GMT ratio (B strain)|2.03|||||TWO_SIDED|95.0|1.73|2.39||||||statistically significantly greater response was concluded if the lower bound of the 95% CI around the vaccine group ratio was \>1.0||2.39|1.73|
71104195|NCT01346592|141715394|SUPERIORITY_OR_OTHER||GMT ratio (H1N1 strain)|3.82||||||95.0|3.14|4.64||||||statistically significantly greater response was concluded if the lower bound of the 95% CI around the vaccine group ratio was \>1.0||4.64|3.14|
71104196|NCT01346592|141715394|SUPERIORITY_OR_OTHER||GMT ratio (H3N2 strain)|2.4|||||TWO_SIDED|95.0|2.15|2.68||||||statistically significantly greater response was concluded if the lower bound of the 95% CI around the vaccine group ratio was \>1.0||2.68|2.15|
71104197|NCT01346592|141715394|SUPERIORITY_OR_OTHER||GMT ratio (B strain)|1.95|||||TWO_SIDED|95.0|1.65|2.29||||||statistically significantly greater response was concluded if the lower bound of the 95% CI around the vaccine group ratio was \>1.0||2.29|1.65|
71104198|NCT02085720|141715415|NON_INFERIORITY_OR_EQUIVALENCE|Data were given as means and standard deviations, unless otherwise stated. AHI was categorized as ≥ 5, ≥ 10, ≥ 15 and ≥ 20. The frequency distribution of responses on the SHQ and their relationship to AHI was assessed with the chi-squared analysis. The association of variables such as age, BMI, neck circumference, ESS and sleep health questionnaire responses versus AHI was evaluated using one-way analysis of variance and Pearson Correlation Analysis.|||||<|0.05|||||||ANOVA|||||||<0.05
71104199|NCT04262479|141715452|OTHER||||||||||||||||||Counting number of events.|||
70850436|NCT01057589|141188596|SUPERIORITY_OR_OTHER|||||||0.45||||||P-value is for EIP, Triplicate Combination Cycle 6. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.45
71104200|NCT04262479|141715453|OTHER||||||||||||||||||Counting number of events|||
71104201|NCT04262479|141715454|OTHER||||||<|0.001||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.001
71104202|NCT04262479|141715455|OTHER||||||<|0.05||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.05
71104203|NCT04262479|141715456|OTHER||||||<|0.61||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.61
71104204|NCT04262479|141715457|OTHER||||||<|0.3||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.30
71104205|NCT04262479|141715458|OTHER||||||<|0.002||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.002
71104206|NCT04262479|141715459|OTHER||||||<|0.72||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.72
71104207|NCT04262479|141715460|OTHER||||||<|0.03||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.03
71104208|NCT04262479|141715461|OTHER||||||<|0.044||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.044
71104209|NCT00937105|141715463|SUPERIORITY_OR_OTHER||Cumulative Probability of no-CIE|92.8|||||TWO_SIDED|95.0|88.6|96.9|||Kaplan-Meier|Cumulative Unadjusted Probability of remaining CIE-free presented for entire cohort (both solution groups) to remain consistent with the primary aim||Cumulative Unadjusted Probability of Remaining Infiltrate Free in entire Cohort||96.9|88.6|
71104210|NCT00937105|141715464|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.737||||0.3923|TWO_SIDED|95.0|0.49|6.156|||Regression, Cox|Univariate hazard ratio provided because non-significant finding did not enter into multivariate analyses|referent is no substantial lens bioburden|To determine if microbial contamination of lenses is a risk factor for CIE||6.156|0.49|0.3923
70929008|NCT01651403|141353751|SUPERIORITY||||||<|0.001|||||||Fisher Exact|Fisher's exact test without adjusting for strata at baseline||||||< 0.001
71048015|NCT00688376|141605174|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4||||0.9088|TWO_SIDED|95.0|-6.74|6.0|||ANCOVA|||RTSS Change from Baseline to Week 12 (LOCF). P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||6|-6.74|0.9088
71048016|NCT00688376|141605175|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.7||||0.2886|TWO_SIDED|95.0|-1.5|4.96|||ANCOVA|||Global Executive Composite Score Analysis. P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||4.96|-1.5|0.2886
71048017|NCT00688376|141605175|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.1||||0.2555|TWO_SIDED|95.0|-1.54|5.69|||ANCOVA|||Behavioral Regulation Index Analysis. P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||5.69|-1.54|0.2555
71048018|NCT00688376|141605175|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.7||||0.3155|TWO_SIDED|95.0|-1.63|4.99|||ANCOVA|||Metacognition Index Analysis. P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||4.99|-1.63|0.3155
71048019|NCT00688376|141605175|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.2||||0.9075|TWO_SIDED|95.0|-3.55|3.16|||ANCOVA|||Working Memory Scale Analysis. P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||3.16|-3.55|0.9075
71048020|NCT04492020|141605179|SUPERIORITY||Odds Ratio (OR)|2.09|||<|0.0001|TWO_SIDED|95.0|1.63|2.69|||generalized linear mixed model (GLMM)|||||2.69|1.63|<.0001
71048021|NCT04492020|141605180|SUPERIORITY||Odds Ratio (OR)|2.13|||<|0.0001|TWO_SIDED|95.0|1.63|2.78|||generalized linear mixed model (GLMM)|||||2.78|1.63|<.0001
71048022|NCT04492020|141605181|SUPERIORITY||Geometric Mean Odds Ratio|1.66|||<|0.0001|TWO_SIDED|95.0|1.4|1.96|||generalized estimating equation (GEE)|||||1.96|1.40|<.0001
70929009|NCT01651403|141353752|SUPERIORITY|||||||0.935|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel test adjusted for age at baseline and region strata||||||0.935
71048023|NCT04492020|141605182|SUPERIORITY||Odds Ratio (OR)|1.93|||<|0.0001|TWO_SIDED|95.0|1.39|2.66|||generalized linear mixed model (GLMM)|||||2.66|1.39|<.0001
71048024|NCT00063635|141605183|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||Since two primary comparisons are planned, a P-value of 0.025 will be considered significant, applying a Bonferroni correction for multiple comparisons.|Mantel Haenszel|||||||0.26
71048025|NCT00063635|141605183|SUPERIORITY_OR_OTHER|||||||0.83||95.0||||Since two primary comparisons are planned, a P-value of 0.025 will be considered significant, applying a Bonferroni correction for multiple comparisons.|Mantel Haenszel|||||||0.83
71048026|NCT00063635|141605184|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||ANCOVA|||||||0.32
71048027|NCT00063635|141605184|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||ANCOVA|||||||0.29
71048028|NCT00063635|141605185|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANCOVA|||||||0.02
71048029|NCT00063635|141605185|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||ANCOVA|||||||0.25
71048030|NCT00063635|141605186|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Chi-squared|||||||0.71
71048031|NCT00063635|141605186|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||Chi-squared|||||||0.72
71048032|NCT00063635|141605187|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Chi-squared|||||||0.18
71048033|NCT00063635|141605187|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Chi-squared|||||||0.25
71048034|NCT00063635|141605188|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Chi-squared|||||||0.89
71048035|NCT00063635|141605188|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Chi-squared|||||||0.73
71048036|NCT00063635|141605189|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Chi-squared|||||||0.02
71048037|NCT00063635|141605189|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Chi-squared|||||||0.02
71048038|NCT00063635|141605190|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||ANCOVA|||||||0.77
71048039|NCT00063635|141605190|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||ANCOVA|||||||0.25
71048040|NCT00063635|141605191|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71048041|NCT00063635|141605191|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||ANCOVA|||||||0.44
71048042|NCT00063635|141605192|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANCOVA|||||||0.08
71048043|NCT00063635|141605192|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||ANCOVA|||||||0.63
71048044|NCT00063635|141605193|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||ANCOVA|||||||0.15
70929010|NCT01651403|141353753|SUPERIORITY|||||||0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata||||||0.001
70929011|NCT01651403|141353755|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata||||||<0.001
71048045|NCT00063635|141605193|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||ANCOVA|||||||0.96
71048046|NCT02792959|141605236|NON_INFERIORITY|alpha=5%|Mean Difference (Net)|0.273||||0.602|TWO_SIDED||||||Kruskal-Wallis|||||||0.602
71048047|NCT02792959|141605237|SUPERIORITY|alpha=5%|Mean Difference (Net)|3.361||||0.067|TWO_SIDED||||||Kruskal-Wallis|||||||0.067
71048048|NCT02792959|141605238|SUPERIORITY|alpha=5%|Mean Difference (Net)|4.0||||0.036|TWO_SIDED||||||Kruskal-Wallis|||||||0.036
71048049|NCT02792959|141605239|SUPERIORITY|alpha=5%|Mean Difference (Net)|1.091||||0.296|TWO_SIDED||||||Kruskal-Wallis|||||||0.296
71048050|NCT02792959|141605240|SUPERIORITY|alpha=5%|Mean Difference (Net)|0.068||||0.794|TWO_SIDED||||||Kruskal-Wallis|||||||0.794
71048051|NCT02792959|141605241|SUPERIORITY|alpha=5%|Mean Difference (Net)|3.361||||0.067|TWO_SIDED||||||Kruskal-Wallis|||||||0.067
71048052|NCT02792959|141605242|SUPERIORITY|alpha=5%|Mean Difference (Net)|1.0||||0.296|TWO_SIDED||||||Kruskal-Wallis|||||||0.296
71048053|NCT02792959|141605243|SUPERIORITY|alpha=5%|Mean Difference (Net)|4.39||||0.036|TWO_SIDED||||||Kruskal-Wallis|||||||0.036
71048054|NCT02792959|141605244|SUPERIORITY|alpha=5%|Mean Difference (Net)|0.068||||0.794|TWO_SIDED||||||Kruskal-Wallis|||||||0.794
71048055|NCT02792959|141605245|SUPERIORITY|alpha=5%|Mean Difference (Net)|4.39||||0.036|TWO_SIDED||||||Kruskal-Wallis|||||||0.036
71048056|NCT02792959|141605246|SUPERIORITY|alpha=5%|Mean Difference (Net)|0.273||||0.602|TWO_SIDED||||||Kruskal-Wallis|||||||0.602
71048057|NCT02792959|141605247|SUPERIORITY|alpha=5%|Mean Difference (Net)|1.705||||0.192|TWO_SIDED||||||Kruskal-Wallis|||||||0.192
70929012|NCT01651403|141353757|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata||||||0.002
71013689|NCT01945034|141534105|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0||||0.85|TWO_SIDED|95.0|-11.9|9.82||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, BLPSR, pooled site blocks, and BLPIWB terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo. Comparison: tested at the 0.05 level of significance (2-sided). A comparison was eligible for being declared significant only if preceding comparison was significant.||9.82|-11.90|0.850
70850437|NCT01057589|141188596|SUPERIORITY_OR_OTHER|||||||0.29||||||P-value is for EIP, Maintenance Cycle 1. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.29
70850438|NCT01057589|141188596|SUPERIORITY_OR_OTHER|||||||0.17||||||P-value is for EIP, Maintenance Cycle 3. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.17
70850439|NCT01057589|141188596|SUPERIORITY_OR_OTHER|||||||0.7||||||P-value is for EIP, Maintenance Cycle 5. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.70
70850440|NCT01057589|141188596|SUPERIORITY_OR_OTHER|||||||0.21||||||P-value is for EIP, Maintenance Cycle 7. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.21
70850441|NCT01057589|141188596|SUPERIORITY_OR_OTHER|||||||0.85||||||P-value is for UOS, Triplicate Combination Cycle 2. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.85
70850442|NCT01057589|141188596|SUPERIORITY_OR_OTHER|||||||0.13||||||P-value is for UOS, Triplicate Combination Cycle 4. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.13
70850443|NCT01057589|141188596|SUPERIORITY_OR_OTHER|||||||0.03||||||P-value is for UOS, Triplicate Combination Cycle 6. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.03
70850444|NCT01057589|141188596|SUPERIORITY_OR_OTHER|||||||0.71||||||P-value is for UOS, Maintenance Cycle 1. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.71
70850445|NCT01057589|141188596|SUPERIORITY_OR_OTHER|||||||0.34||||||P-value is for UOS, Maintenance Cycle 3. Threshold for statistical significance was 0.05|t-test, 2 sided|||||||0.34
70850446|NCT01057589|141188596|SUPERIORITY_OR_OTHER|||||||0.41||||||P-value is for UOS, Maintenance Cycle 5. Threshold for statistical significance was 0.05|t-test, 2 sided|||||||0.41
70850447|NCT01057589|141188596|SUPERIORITY_OR_OTHER|||||||0.37||||||P-value is for UOS, Maintenance Cycle 7. Threshold for statistical significance was 0.05|t-test, 2 sided|||||||0.37
70850448|NCT01253577|141188618|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||McNemar|||||||0.0280
70850449|NCT01253577|141188619|SUPERIORITY_OR_OTHER||||||<|0.0001|ONE_SIDED|95.0|||||Fisher Exact|||||||<0.0001
70850450|NCT01253577|141188620|SUPERIORITY_OR_OTHER|||||||0.0023|TWO_SIDED|95.0|||||McNemar|||||||0.0023
70850451|NCT05475483|141188946|OTHER||Mean Difference (Final Values)|-1.27|||=|0.045|TWO_SIDED|95.0|-2.51|-0.03|||Mixed Models Analysis|||||-0.03|-2.51|= 0.045
70850452|NCT05475483|141188947|OTHER||Odds Ratio (OR)|2.22|||=|0.078|TWO_SIDED|95.0|0.91|5.37|||Regression, Logistic|||||5.37|0.91|= 0.078
70850453|NCT05475483|141188948|OTHER||Odds Ratio (OR)|1.95||||0.143|TWO_SIDED|95.0|0.8|4.76|||Regression, Logistic|||||4.76|0.80|0.143
70850454|NCT05475483|141188949|OTHER||Mean Difference (Final Values)|-1.78|||=|0.032|TWO_SIDED|95.0|-3.4|-0.16|||Mixed Models Analysis|||||-0.16|-3.40|= 0.032
70850455|NCT02923921|141188985|SUPERIORITY||Hazard Ratio (HR)|1.045||||0.6565|TWO_SIDED|95.0|0.863|1.265|||Log Rank|||The primary test to compare overall survival between treatment arms was the two-sided log-rank test, stratified by region and prior therapy. The estimate of the hazard ration (HR) - (Pegilodecakin + FOLFOX Arm / FOLFOX Arm) and the corresponding 95% CI was computed using a Cox proportional hazards model stratified by randomization stratification factors. Randomization stratification factors were based on the data recorded in interactive voice response system (IVRS).||1.265|0.863|0.6565
70850456|NCT02923921|141188986|SUPERIORITY||Hazard Ratio (HR)|0.981||||0.8144|TWO_SIDED|95.0|0.808|1.19|||Log Rank|||The estimate of hazard ratio (HR) was stratified by region and prior therapy.||1.190|0.808|0.8144
70850457|NCT02923921|141188987|SUPERIORITY||Odds Ratio (OR)|0.8||||0.7044|TWO_SIDED|95.0|0.4|1.7||P-value is calculated by Exact Cochran-Mantel-Haenszel test stratified by the randomization strata Prior Therapy - interactive voice response system (IVRS), Geographic Region - IVRS.|Cochran-Mantel-Haenszel|||||1.7|0.4|0.7044
70850458|NCT02923921|141188988|SUPERIORITY||Odds Ratio (OR)|1.3||||0.1463|TWO_SIDED|95.0|0.9|1.8||P-value is calculated by Exact Cochran-Mantel-Haenszel test stratified by the randomization strata Prior Therapy - interactive voice response system (IVRS), Geographic Region - IVRS.|Cochran-Mantel-Haenszel|||||1.8|0.9|0.1463
70929013|NCT01651403|141353759|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata||||||<0.001
71013690|NCT01945034|141534105|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.8||||0.385|TWO_SIDED|95.0|-18.91|7.32||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, BLPSR, pooled site blocks, and BLPIWB terms. A comparison was eligible for being declared significant only if preceding comparison was significant.||7.32|-18.91|0.385
71013691|NCT01945034|141534106|SUPERIORITY_OR_OTHER||LS Mean Difference|10.0||||0.072|TWO_SIDED|95.0|-0.92|20.91||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||20.91|-0.92|0.072
71013692|NCT01945034|141534106|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.3||||0.296|TWO_SIDED|95.0|-15.4|4.7||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||4.70|-15.40|0.296
71013693|NCT01945034|141534106|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.3||||0.014|TWO_SIDED|95.0|-27.53|-3.16||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity at rest terms.||-3.16|-27.53|0.014
71013694|NCT01945034|141534107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.305|TWO_SIDED|95.0|-0.1|0.3||p-value \<=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo||0.30|-0.10|0.305
71048058|NCT03914950|141605257|OTHER|"The calculation of power and sample size is based on a formula that selects the sample size so that the lower limit of the 95% confidence interval by the expected specificity of the new method most probably exceeds the specificity value of the current method.~Receiver operating characteristics (ROC) analysis of the values of SUVmax of the early and delayed images with and without TOF of all pancreatic lesions was done in correlation with the histopathological findings."||||||0.78|||||||DeLong-test|The threshold for statistical significance was p=0.05.||It was calculated that 118 participants would have at least 90% power to demonstrate an improvement in specificity of 25% (to 70%) with the new method assuming a specificity of the current method of 45% at a prevalence of malignant lesions of 70% (corresponding to 30% benign lesions). Assumptions included a discontinuation rate of 25%.||||0.78
71048059|NCT03914950|141605257|OTHER|||||||0.95|||||||DeLong-test|The threshold for statistical significance was p=0.05.||||||0.95
71048060|NCT04168190|141605278|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|-10.0|||||TWO_SIDED|95.0|-29.3|9.0|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Injection site erythema||9.0|-29.3|
71048061|NCT04168190|141605278|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|3.3|||||TWO_SIDED|95.0|-18.1|24.6|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Injection site erythema||24.6|-18.1|
71048062|NCT04168190|141605278|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|16.7|||||TWO_SIDED|95.0|-7.7|39.3|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Injection site pain||39.3|-7.7|
71048063|NCT04168190|141605278|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|20.0|||||TWO_SIDED|95.0|-4.1|42.1|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Injection site pain||42.1|-4.1|
71048064|NCT04168190|141605278|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|6.7|||||TWO_SIDED|95.0|-13.2|26.5|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Injection site swelling||26.5|-13.2|
71048065|NCT04168190|141605278|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|3.3|||||TWO_SIDED|95.0|-16.0|22.8|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Injection site swelling||22.8|-16.0|
71048066|NCT04168190|141605279|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|10.0|||||TWO_SIDED|95.0|-11.4|31.0|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Fatigue||31.0|-11.4|
71048067|NCT04168190|141605279|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|10.0|||||TWO_SIDED|95.0|-11.4|31.0|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Fatigue||31.0|-11.4|
71048068|NCT04168190|141605279|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|10.0|||||TWO_SIDED|95.0|-7.4|28.3|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Arthralgia||28.3|-7.4|
71048069|NCT04168190|141605279|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|3.3|||||TWO_SIDED|95.0|-13.1|20.2|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Arthralgia||20.2|-13.1|
71048070|NCT04168190|141605279|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|13.3|||||TWO_SIDED|95.0|-7.5|33.8|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Myalgia||33.8|-7.5|
71048071|NCT04168190|141605279|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|16.7|||||TWO_SIDED|95.0|-4.6|37.3|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Myalgia||37.3|-4.6|
71048072|NCT04168190|141605279|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|13.3|||||TWO_SIDED|95.0|-8.5|34.5|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Headache||34.5|-8.5|
71048073|NCT04168190|141605279|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|3.3|||||TWO_SIDED|95.0|-17.2|23.8|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Headache||23.8|-17.2|
71048074|NCT04168190|141605280|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-11.5|11.5|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|||11.5|-11.5|
71048075|NCT04168190|141605280|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-11.5|11.5|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|||11.5|-11.5|
71048076|NCT04168190|141605281|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|2.0|||||TWO_SIDED|95.0|-2.8|6.8|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Injection site erythema||6.8|-2.8|
71048077|NCT04168190|141605281|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|8.7|||||TWO_SIDED|95.0|0.1|17.1|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Injection site pain||17.1|0.1|
71048078|NCT04168190|141605281|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|3.1|||||TWO_SIDED|95.0|-2.0|8.4|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Injection site swelling||8.4|-2.0|
71048079|NCT04168190|141605282|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|7.1|||||TWO_SIDED|95.0|0.8|13.5|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Fatigue||13.5|0.8|
71048080|NCT04168190|141605282|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.8|3.8|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Arthralgia||3.8|-3.8|
71048081|NCT04168190|141605282|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|1.6|||||TWO_SIDED|95.0|-3.8|7.0|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Myalgia||7.0|-3.8|
71048082|NCT04168190|141605282|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|3.5|||||TWO_SIDED|95.0|-2.7|9.9|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Headache||9.9|-2.7|
71048083|NCT04168190|141605283|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-1.5|1.5|||||Phase 2: V116 minus Phase 2: Pneumovax™23|||1.5|-1.5|
71013695|NCT01945034|141534107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.261|TWO_SIDED|95.0|-0.08|0.29||p-value \<=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.29|-0.08|0.261
71013696|NCT01945034|141534107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.996|TWO_SIDED|95.0|-0.22|0.22||p-value \<=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms.||0.22|-0.22|0.996
71013697|NCT01945034|141534107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.21|TWO_SIDED|95.0|-0.08|0.36||p-value \<=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.36|-0.08|0.210
71013698|NCT01945034|141534107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.556|TWO_SIDED|95.0|-0.14|0.27||p-value \<=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.27|-0.14|0.556
71013699|NCT01945034|141534107|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.534|TWO_SIDED|95.0|-0.33|0.17||p-value \<=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms.||0.17|-0.33|0.534
71013700|NCT01945034|141534108|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.354|TWO_SIDED|95.0|-0.27|0.1||p-value \<=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.10|-0.27|0.354
71013701|NCT01945034|141534108|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.237|TWO_SIDED|95.0|-0.28|0.07||p-value \<=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.07|-0.28|0.237
71013702|NCT01945034|141534108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.871|TWO_SIDED|95.0|-0.23|0.19||p-value \<=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms.||0.19|-0.23|0.871
71013703|NCT01945034|141534108|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.05|TWO_SIDED|95.0|-0.43|0.0||p-value \<=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||-0.00|-0.43|0.050
71013704|NCT01945034|141534108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.64|TWO_SIDED|95.0|-0.25|0.15||p-value \<=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.15|-0.25|0.640
71013705|NCT01945034|141534108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.18|TWO_SIDED|95.0|-0.08|0.41||p-value \<=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms.||0.41|-0.08|0.180
71013706|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.771|TWO_SIDED|95.0|-0.38|0.51|||ANOVA|||At Rest 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.51|-0.38|0.771
71013707|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.022|TWO_SIDED|95.0|-0.88|-0.07|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||-0.07|-0.88|0.022
71048084|NCT04168190|141605284|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.82|1.22|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 3. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.22|0.82|<0.001
71048085|NCT04168190|141605284|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.22|||<|0.001|TWO_SIDED|95.0|0.95|1.56|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 7F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.56|0.95|<0.001
71048086|NCT04168190|141605284|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.13|||<|0.001|TWO_SIDED|95.0|0.9|1.41|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 19A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.41|0.90|<0.001
71048087|NCT04168190|141605284|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.58|||<|0.001|TWO_SIDED|95.0|1.16|2.16|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 22F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.16|1.16|<0.001
70929014|NCT01651403|141353761|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata||||||<0.001
70929015|NCT01651403|141353763|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata||||||<0.001
70929016|NCT01651403|141353765|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|two-sided Cochran-Mantel-Haenszel test adjusted for age at baseline and region strata||||||<0.001
70929017|NCT01651403|141353767|SUPERIORITY||||||>|0.999|||||||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test adjusted for age at baseline and region strata||||||>0.999
70929018|NCT01651403|141353775|OTHER|Comparison of the difference in percentages|Exact Chan-Zhang method|11.4|||||TWO_SIDED|95.0|-6.9|25.1||||||||25.1|-6.9|
70929019|NCT01651403|141353776|OTHER|Comparison of the difference in percentages|Exact Chan-Zhang method|11.4|||||TWO_SIDED|95.0|-6.9|25.1||||||||25.1|-6.9|
71104211|NCT00937105|141715465|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.316||||0.7943|TWO_SIDED|95.0|0.167|10.393|||Regression, Cox|Univariate hazard ratio provided because non-significant finding did not enter into multivariate analyses|referent is no corneal staining|||10.393|0.167|0.7943
71104212|NCT00937105|141715466|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.674||||0.5894|TWO_SIDED|95.0|0.161|2.822|||Regression, Cox|Univariate hazard ratio provided because non-significant finding did not enter into multivariate analyses|referent is no substantial case bioburden|||2.822|0.161|0.5894
71104213|NCT00937105|141715467|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.406||||0.1742|TWO_SIDED|95.0|0.678|8.537||Univariate hazard ratio provided because non-significant finding did not enter into multivariate analyses|Regression, Cox||referent is no substantial overall lid bioburden|||8.537|0.678|0.1742
71104214|NCT00937105|141715468|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.22||||0.04|TWO_SIDED|95.0|1.1|24.7|||Regression, Cox|Multivariate model adjusted for solution, gender and age|referent is no substantial CNS lid bioburden|||24.70|1.10|0.04
71104215|NCT03537508|141715469|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|1.86|||||TWO_SIDED|95.0|-4.38|8.64||||||Statistical analysis for Serogroup A||8.64|-4.38|
70850459|NCT02923921|141188989|SUPERIORITY||Hazard Ratio (HR)|1.008||||0.9952|TWO_SIDED|95.0|0.37|2.741|||Log Rank|||The estimate of hazard ratio (HR) was stratified by region and prior therapy.||2.741|0.370|0.9952
70850460|NCT02923921|141188990|SUPERIORITY||Mean Difference (Final Values)|-4.4||||0.2298|TWO_SIDED|95.0|-11.6|2.8|||Log Rank|||||2.8|-11.6|0.2298
70929020|NCT01651403|141353777|SUPERIORITY|||||||0.007|||||||ANOVA|two-sided superiority test||||||0.007
70929021|NCT01651403|141353779|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel test adjusted for age at baseline and region strata||||||<0.001
70929022|NCT05873556|141353780|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|0.97||||0.83|TWO_SIDED|95.0|0.74|1.27|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.27|0.74|0.83
70929023|NCT05873556|141353780|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.07||||0.61|TWO_SIDED|95.0|0.83|1.38|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.38|0.83|0.61
70929024|NCT05873556|141353781|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|1.16||||0.45|TWO_SIDED|95.0|0.79|1.72|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.72|0.79|0.45
70929025|NCT05873556|141353781|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.17||||0.46|TWO_SIDED|95.0|0.77|1.79|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.79|0.77|0.46
70941527|NCT05244226|141383809|SUPERIORITY|||||||0.021|||||||Kruskal-Wallis|Dunn's Kruskal Wallis with Bonferroni correction||||||0.021
71104216|NCT03537508|141715469|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|8.75|||||TWO_SIDED|95.0|4.8|13.6||||||Statistical analysis for Serogroup C||13.60|4.80|
71104217|NCT03537508|141715469|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|4.09|||||TWO_SIDED|95.0|0.68|8.44||||||Statistical analysis for Serogroup Y||8.44|0.68|
71104218|NCT03537508|141715469|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|1.19|||||TWO_SIDED|95.0|-1.18|4.45||||||Statistical analysis for Serogroup W||4.45|-1.18|
71104219|NCT03537508|141715470|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|10.21|||||TWO_SIDED|95.0|4.98|15.59||||||Statistical analysis for Serogroup A||15.59|4.98|
70929026|NCT05873556|141353782|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|0.95||||0.62|TWO_SIDED|95.0|0.77|1.17|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.17|0.77|0.62
70929027|NCT05873556|141353782|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.14||||0.34|TWO_SIDED|95.0|0.87|1.48|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.48|0.87|0.34
70929028|NCT05873556|141353783|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|1.08||||0.66|TWO_SIDED|95.0|0.76|1.54|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.54|0.76|0.66
70929029|NCT05873556|141353783|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.02||||0.92|TWO_SIDED|95.0|0.75|1.38|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.38|0.75|0.92
70850461|NCT00479687|141188991|SUPERIORITY|||||||0.038||||||There was a single primary variable and the a-prior threshold for statistical significance was 0.05.|Mixed Models Analysis|mixed effects repeated measure model with baseline VAS, treatment, and week as fixed effects and subject nested within site as a random effect.||||||0.0380
70929030|NCT04447040|141353828|SUPERIORITY||Least square (LS) Mean Difference|31.48|STANDARD_ERROR_OF_MEAN|5.379|<|0.001|TWO_SIDED|95.0|20.9|42.07|||ANOVA|||||42.07|20.90|<0.001
70929031|NCT04447040|141353828|SUPERIORITY||LS Mean Difference|41.38|STANDARD_ERROR_OF_MEAN|5.267|<|0.001|TWO_SIDED|95.0|31.02|51.75|||ANOVA|||||51.75|31.02|<0.001
70929032|NCT04447040|141353828|SUPERIORITY||LS Mean Difference|46.86|STANDARD_ERROR_OF_MEAN|5.292|<|0.001|TWO_SIDED|95.0|36.44|57.27|||ANOVA|||||57.27|36.44|<0.001
70929033|NCT04447040|141353828|SUPERIORITY||LS Mean Difference|54.04|STANDARD_ERROR_OF_MEAN|5.321|<|0.001|TWO_SIDED|95.0|43.57|64.51|||ANOVA|||||64.51|43.57|<0.001
70929034|NCT04447040|141353828|SUPERIORITY||LS Mean Difference|59.92|STANDARD_ERROR_OF_MEAN|5.468|<|0.001|TWO_SIDED|95.0|49.16|70.68|||ANOVA|||||70.68|49.16|<0.001
70929035|NCT04447040|141353829|SUPERIORITY||LS Mean Difference|35.66|STANDARD_ERROR_OF_MEAN|6.542|<|0.001|TWO_SIDED|95.0|22.79|48.54|||ANOVA|||||48.54|22.79|<0.001
70929036|NCT04447040|141353829|SUPERIORITY||LS Mean Difference|49.04|STANDARD_ERROR_OF_MEAN|6.407|<|0.001|TWO_SIDED|95.0|36.44|61.65|||ANOVA|||||61.65|36.44|<0.001
70929037|NCT04447040|141353829|SUPERIORITY||LS Mean Difference|53.64|STANDARD_ERROR_OF_MEAN|6.437|<|0.001|TWO_SIDED|95.0|40.97|66.31|||ANOVA|||||66.31|40.97|<0.001
70929038|NCT04447040|141353829|SUPERIORITY||LS Mean Difference|60.93|STANDARD_ERROR_OF_MEAN|6.472|<|0.001|TWO_SIDED|95.0|48.19|73.67|||ANOVA|||||73.67|48.19|<0.001
70929039|NCT04447040|141353829|SUPERIORITY||LS Mean Difference|67.58|STANDARD_ERROR_OF_MEAN|6.65|<|0.001|TWO_SIDED|95.0|54.49|80.67|||ANOVA|||||80.67|54.49|<0.001
70929040|NCT04447040|141353830|SUPERIORITY||LS mean Difference|12.53|STANDARD_ERROR_OF_MEAN|3.097|<|0.001|TWO_SIDED|95.0|6.44|18.63|||ANOVA|||||18.63|6.44|<0.001
71048088|NCT04168190|141605284|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.71|1.24|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 33F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.24|0.71|<0.001
71048089|NCT04168190|141605284|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|0.99|||<|0.001|TWO_SIDED|95.0|0.8|1.21|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 8. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.21|0.80|<0.001
71048090|NCT04168190|141605284|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.13|||<|0.001|TWO_SIDED|95.0|0.87|1.47|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 9N. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.47|0.87|<0.001
71048091|NCT04168190|141605284|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.19|||<|0.001|TWO_SIDED|95.0|0.93|1.52|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 10A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.52|0.93|<0.001
71048092|NCT04168190|141605284|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|2.27|||<|0.001|TWO_SIDED|95.0|1.78|2.9|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 11A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.90|1.78|<0.001
70929041|NCT04447040|141353830|SUPERIORITY||LS MEAN Difference|17.73|STANDARD_ERROR_OF_MEAN|3.032|<|0.001|TWO_SIDED|95.0|11.76|23.7|||ANOVA|||||23.70|11.76|<0.001
70929042|NCT04447040|141353830|SUPERIORITY||LS Mean Difference|21.88|STANDARD_ERROR_OF_MEAN|3.047|<|0.001|TWO_SIDED|95.0|15.89|27.88|||ANOVA|||||27.88|15.89|<0.001
70929043|NCT04447040|141353830|SUPERIORITY||LS Mean Difference|25.01|STANDARD_ERROR_OF_MEAN|3.063|<|0.001|TWO_SIDED|95.0|18.98|31.03|||ANOVA|||||31.03|18.98|<0.001
70929044|NCT04447040|141353830|SUPERIORITY||LS Mean Difference|29.3|STANDARD_ERROR_OF_MEAN|3.148|<|0.001|TWO_SIDED|95.0|23.11|35.5|||ANOVA|||||35.50|23.11|<0.001
70929045|NCT04447040|141353831|SUPERIORITY||||||<|0.001|||||||Wilcoxon test|||||||<0.001
70929046|NCT04447040|141353831|SUPERIORITY||||||<|0.001|||||||Wilcoxon test|||||||<0.001
71048093|NCT04168190|141605284|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|2.57|||<|0.001|TWO_SIDED|95.0|1.86|3.55|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 12F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||3.55|1.86|<0.001
70929047|NCT04447040|141353831|SUPERIORITY||||||<|0.001|||||||Wilcoxon test|||||||<0.001
70929048|NCT04447040|141353831|SUPERIORITY||||||<|0.001|||||||Wilcoxon test|||||||<0.001
70929049|NCT04447040|141353831|SUPERIORITY||||||<|0.001|||||||Wilcoxon test|||||||<0.001
70929050|NCT04447040|141353832|SUPERIORITY|||||||0.014|||||||Wald method|||||||0.014
70929051|NCT04447040|141353832|SUPERIORITY|||||||0.002|||||||Wald method|||||||0.002
70929052|NCT04447040|141353832|SUPERIORITY||||||<|0.001|||||||Wald method|||||||<0.001
70929053|NCT04447040|141353832|SUPERIORITY||||||<|0.001|||||||Wald method|||||||<0.001
70929054|NCT04447040|141353832|SUPERIORITY||||||<|0.001|||||||Wald method|||||||<0.001
70929055|NCT01928394|141353876|SUPERIORITY||Odds Ratio (OR)|2.12||||0.0309|TWO_SIDED|95.0|1.06|4.26|||Cochran-Mantel-Haenszel|||SCLC Arm N Expansion as compare to SCLC Arm N-I Dose Level 2- Expansion||4.26|1.06|0.0309
70929056|NCT04433208|141353877|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
70929057|NCT02398656|141353890|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.88|1.04||||||||1.04|0.88|
70929058|NCT04299464|141353892|SUPERIORITY||Difference in Adjusted Mean|-0.432||||0.765|TWO_SIDED|80.0|-2.291|1.428|||ANCOVA|||||1.428|-2.291|0.7650
70929059|NCT04299464|141353892|SUPERIORITY||Difference in Adjusted Mean|-0.4444||||0.7517|TWO_SIDED|80.0|-2.25|1.363|||ANCOVA|||||1.363|-2.250|0.7517
70929060|NCT04299464|141353901|SUPERIORITY||Difference in Adjusted Mean|1.741||||0.6082|TWO_SIDED|80.0|-2.631|6.114|||ANCOVA|||||6.114|-2.631|0.6082
70929061|NCT04299464|141353901|SUPERIORITY||Difference in Adjusted Mean|-1.715||||0.6228|TWO_SIDED|80.0|-6.204|2.774|||ANCOVA|||||2.774|-6.204|0.6228
70929062|NCT04299464|141353902|SUPERIORITY||Difference in Adjusted Mean|-2.983||||0.1987|TWO_SIDED|80.0|-5.957|-0.009|||ANCOVA|||||-0.009|-5.957|0.1987
70929063|NCT04299464|141353902|SUPERIORITY||Difference in Adjusted Mean|-4.474||||0.046|TWO_SIDED|80.0|-7.326|-1.622|||ANCOVA|||||-1.622|-7.326|0.0460
70929064|NCT04299464|141353903|SUPERIORITY||Difference in Adjusted Means|1.279||||0.4746|TWO_SIDED|80.0|-1.021|3.578|||ANCOVA|||||3.578|-1.021|0.4746
70929065|NCT04299464|141353903|SUPERIORITY||Difference in Adjusted Means|2.697||||0.1244|TWO_SIDED|80.0|0.453|4.94|||ANCOVA|||||4.940|0.453|0.1244
70929066|NCT03676192|141353904|EQUIVALENCE|The similarity criterion had been set such that the confidence limits of the 95% confidence interval (CI) of the difference of ORR from each treatment group was entirely bounded by the interval (-12.5, 12.5).|Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-7.02|7.83||||||Logistic regression model including treatment groups (CT-P16 and EU-approved Avastin) as a fixed effect and region (EMEA vs. America vs. Asia), sex (female vs. male), disease status at baseline (recurrence vs. metastatic), and ECOG performance score at baseline (0 vs. 1) as covariates was used.||7.83|-7.02|
70929067|NCT03676192|141353904|EQUIVALENCE|The similarity criterion had been set such that the confidence limits of the 90% confidence interval (CI) of the ratio of ORR from each treatment group was entirely bounded by the interval (0.7368, 1.3572).|Risk Ratio (RR)|1.0136|||||TWO_SIDED|90.0|0.8767|1.1719||||||Log-binomial regression model including treatment groups (CT-P16 and EU-approved Avastin) as a fixed effect and region (EMEA vs. America vs. Asia), sex (female vs. male), disease status at baseline (recurrence vs. metastatic), and ECOG performance score at baseline (0 vs. 1) as covariates was used.||1.1719|0.8767|
70929068|NCT03676192|141353907|OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.77|1.1||||||Adjusted stratified Cox regression model is used to estimate the hazard ratio and its 95% CI for receiving CT-P16 compared with receiving EU-approved Avastin using region (EMEA vs. America vs. Asia), sex (female vs. male), disease status at baseline (recurrence vs. metastatic), and ECOG performance score at baseline (0 vs. 1) as stratification factors.||1.10|0.77|
70929069|NCT03676192|141353908|OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.77|1.19||||||Adjusted stratified Cox regression model is used to estimate the hazard ratio and its 95% CI for receiving CT-P16 compared with receiving EU-approved Avastin using region (EMEA vs. America vs. Asia), sex (female vs. male), disease status at baseline (recurrence vs. metastatic), and ECOG performance score at baseline (0 vs. 1) as stratification factors.||1.19|0.77|
70929070|NCT01868997|141353952|SUPERIORITY||Odds Ratio (OR)|8.86|||<|0.001|TWO_SIDED|95.0|3.293|23.825||Odds ratio, 95% confidence interval, and P-value are obtained from a logistic regression model with treatment and smoking status as covariates.|Regression, Logistic|||||23.825|3.293|< 0.001
70929071|NCT01868997|141353953|SUPERIORITY||Difference in Least Squares Mean|10.97|STANDARD_ERROR_OF_MEAN|3.221||0.001|TWO_SIDED|95.0|4.561|17.375|||Mixed-Model Repeated Measures|||||17.375|4.561|0.001
70929072|NCT01868997|141353954|SUPERIORITY||Difference in Least Squares Mean|-2.31|STANDARD_ERROR_OF_MEAN|0.269|<|0.001|TWO_SIDED|95.0|-2.843|-1.772|||Mixed-Model Repeated Measures|||||-1.772|-2.843|< 0.001
70929073|NCT01868997|141353955|SUPERIORITY||Difference in Least Squares Mean|-1.59|STANDARD_ERROR_OF_MEAN|0.245|<|0.001|TWO_SIDED|95.0|-2.073|-1.098|||Mixed-Model Repeated Measures|||||-1.098|-2.073|< 0.001
70929074|NCT01868997|141353956|SUPERIORITY||Difference in Least Squares Mean|14.16|STANDARD_ERROR_OF_MEAN|3.827|<|0.001|TWO_SIDED|95.0|6.549|21.773|||Mixed-Model Repeated Measures|||||21.773|6.549|< 0.001
70929075|NCT01868997|141353957|SUPERIORITY||Difference in Least Squares Mean|6.32|STANDARD_ERROR_OF_MEAN|3.81||0.101|TWO_SIDED|95.0|-1.255|13.901|||Mixed-Model Repeated Measures|||||13.901|-1.255|0.101
70929076|NCT04778397|141353960|SUPERIORITY||Stratified Hazard Ratio|1.132||||0.507|TWO_SIDED|95.0|0.783|1.637|||Stratified log-rank test|P-value from stratified log-rank test.|||Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model, adjusted for randomization stratification factors (appropriateness for non-intensive therapy vs intensive therapy, age (\< 75 years, \>=75 years), geographic region (US sites, outside the US sites)).|1.637|0.783|0.5070
70929077|NCT04778397|141353961|SUPERIORITY||Stratified Hazard Ratio|1.183||||0.3237|TWO_SIDED|95.0|0.845|1.654|||Stratified Log-rank test|P-value from stratified log-rank test.|||Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model, adjusted for randomization stratification factors (appropriateness for non-intensive therapy vs intensive therapy, age (\< 75 years, \>=75 years), geographic region (US sites, outside the US sites)).|1.654|0.845|0.3237
70929078|NCT04778397|141353962|SUPERIORITY||Stratified Hazard Ratio|1.389||||0.0661|TWO_SIDED|95.0|1.043|1.848|||Stratified Log-rank test|P-value for comparing the event free survival functions from the two treatment groups was from stratified log-rank test, adjusted for randomization.|||Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model, adjusted for randomization stratification factors: therapy appropriateness, age (\< 75 years, \>=75 years), geographic region (US sites, outside the US sites).|1.848|1.043|0.0661
70929079|NCT04778397|141353963|SUPERIORITY||Stratified Odds Ratio|0.25|||||TWO_SIDED|95.0|0.123|0.506|||||||Odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for randomization stratification factors (appropriateness for non-intensive therapy versus intensive therapy, age (\< 75 years, \>=75 years), geographic region (US sites, outside US sites)).|0.506|0.123|
70929080|NCT04778397|141353964|SUPERIORITY||Stratified Odds Ratio|0.072|||||TWO_SIDED|95.0|0.009|0.559|||||||Odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for randomization stratification factors (appropriateness for non-intensive therapy versus intensive therapy, age (\< 75 years, \>=75 years), geographic region (US sites, outside US sites)).|0.559|0.009|
70929081|NCT04778397|141353965|SUPERIORITY||Stratified Odds Ratio|0.215|||||TWO_SIDED|95.0|0.108|0.428|||||||Odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for randomization stratification factors (appropriateness for non-intensive therapy versus intensive therapy, age (\< 75 years, \>=75 years), geographic region (US sites, outside US sites)).|0.428|0.108|
70929082|NCT04587453|141354104|OTHER|No formal testing was performed. Confidence intervals (CIs) are presented with two sided 95% degree of confidence.|Risk Difference (RD)|5.7|||||TWO_SIDED|95.0|-11.2|22.5|||||Mantel-Haenzel risk difference, stratified by baseline IGA.|Responders were considered those meeting an IGA score of 0 or 1 (clear or almost clear). Subjects with missing data or subjects who had received rescue medication prior to Week 16 were considered non-responders in the primary analysis of the primary estimand.||22.5|-11.2|
71013708|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.032|TWO_SIDED|95.0|-1.03|-0.05|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.05|-1.03|0.032
71013709|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.72|TWO_SIDED|95.0|-0.38|0.55|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.55|-0.38|0.720
71013710|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.194|TWO_SIDED|95.0|-0.71|0.15|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.15|-0.71|0.194
71013711|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.163|TWO_SIDED|95.0|-0.89|0.15|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.15|-0.89|0.163
71013712|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.644|TWO_SIDED|95.0|-0.4|0.64|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.64|-0.40|0.644
71048094|NCT04168190|141605284|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.64|||<|0.001|TWO_SIDED|95.0|1.24|2.16|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 17F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.16|1.24|<0.001
71048095|NCT04168190|141605284|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.84|||<|0.001|TWO_SIDED|95.0|1.43|2.36|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 20A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.36|1.43|<0.001
71048096|NCT04168190|141605285|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|6.03|||<|0.001|TWO_SIDED|95.0|4.23|8.62|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 6A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||8.62|4.23|<0.001
71048097|NCT04168190|141605285|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|6.8|||<|0.001|TWO_SIDED|95.0|5.37|8.62|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 15A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||8.62|5.37|<0.001
71048098|NCT04168190|141605285|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|3.0|||<|0.001|TWO_SIDED|95.0|2.31|3.9|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 15C. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||3.90|2.31|<0.001
71048099|NCT04168190|141605285|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|18.21|||<|0.001|TWO_SIDED|95.0|12.98|25.57|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 16F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||25.57|12.98|<0.001
71048100|NCT04168190|141605285|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|19.45|||<|0.001|TWO_SIDED|95.0|12.87|29.4|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 23A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||29.40|12.87|<0.001
71048101|NCT04168190|141605285|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|29.88|||<|0.001|TWO_SIDED|95.0|20.72|43.09|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 23B. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||43.09|20.72|<0.001
71048102|NCT04168190|141605285|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|32.02|||<|0.001|TWO_SIDED|95.0|22.83|44.89|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 24F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||44.89|22.83|<0.001
70929083|NCT04587453|141354105|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Risk Difference (RD)|15.1|||||TWO_SIDED|95.0|-2.9|33.0|||||Mantel-Haenzel risk difference, stratified by baseline IGA.|Subjects with 75% reduction in EASI were considered responders. Subjects with missing data or subjects who had received rescue medication prior to Week 16 were considered non-responders in the primary analysis of the primary estimand.||33.0|-2.9|
71048103|NCT04168190|141605285|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|34.9|||<|0.001|TWO_SIDED|95.0|24.25|50.23|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 31. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||50.23|24.25|<0.001
71048104|NCT04168190|141605285|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|9.0|||<|0.001|TWO_SIDED|95.0|7.19|11.26|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 35B. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||11.26|7.19|<0.001
71048105|NCT04168190|141605286|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.91|||||TWO_SIDED|95.0|0.58|1.42|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 3||1.42|0.58|
71048106|NCT04168190|141605286|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.12|||||TWO_SIDED|95.0|0.71|1.76|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 3||1.76|0.71|
71048107|NCT04168190|141605286|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.12|||||TWO_SIDED|95.0|0.63|1.99|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 7F||1.99|0.63|
71048108|NCT04168190|141605286|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|2.14|||||TWO_SIDED|95.0|1.19|3.84|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 7F||3.84|1.19|
71048109|NCT04168190|141605286|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.27|||||TWO_SIDED|95.0|0.74|2.21|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 19A||2.21|0.74|
70929084|NCT04587453|141354106|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Mean Difference (Net)|-5.1|||||TWO_SIDED|95.0|-12.4|2.3|||||Analysis of covariance (ANCOVA). Worst observation carried forward for all subjects who prior to Week 16 had received rescue medication. Multiple imputation of missing values for subjects who had not received rescue medication.|||2.3|-12.4|
71048110|NCT04168190|141605286|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|2.08|||||TWO_SIDED|95.0|1.19|3.63|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 19A||3.63|1.19|
71048111|NCT04168190|141605286|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.74|||||TWO_SIDED|95.0|0.37|1.46|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 22F||1.46|0.37|
70929085|NCT04587453|141354107|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Mean Difference (Net)|-1.1|||||TWO_SIDED|95.0|-2.7|0.5|||||ANCOVA. Worst observation carried forward for all subjects who prior to Week 16 had received rescue medication. Multiple imputation of missing values for subjects who had not received rescue medication.|||0.5|-2.7|
70929086|NCT04587453|141354108|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Risk Difference (RD)|-3.8|||||TWO_SIDED|95.0|-21.7|14.2|||||Mantel-Haenszel risk difference, stratified by baseline IGA.|Subjects with at least a reduction of 4 in the worst daily pruritus NRS score were considered responders. Subjects who had received rescue medication were considered non-responders. Subjects with missing data at Week 16 were imputed as non-responders.||14.2|-21.7|
71048112|NCT04168190|141605286|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.0|||||TWO_SIDED|95.0|0.5|2.0|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 22F||2.00|0.50|
71048113|NCT04168190|141605286|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.75|||||TWO_SIDED|95.0|0.4|1.41|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 33F||1.41|0.40|
71048114|NCT04168190|141605286|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.32|||||TWO_SIDED|95.0|0.7|2.48|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 33F||2.48|0.70|
71048115|NCT04168190|141605286|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.64|||||TWO_SIDED|95.0|0.37|1.08|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 8||1.08|0.37|
70929087|NCT04587453|141354109|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Risk Difference (RD)|15.1|||||TWO_SIDED|95.0|-3.0|33.2|||||Mantel-Haenszel risk difference, stratified by baseline IGA.|Subjects with a reduction of 90% in EASI were considered responders. Subjects who had received rescue medication were considered non-responders. Subjects with missing data were imputed as non-responders.||33.2|-3.0|
70929088|NCT04587453|141354110|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Risk Difference (RD)|5.7|||||TWO_SIDED|95.0|-9.0|20.3|||||Mantel-Haenszel risk difference, stratified by baseline IGA.|Subjects with at least 50% reduction in EASI were considered responders. Subjects who had received rescue medication were considered non-responders. Subjects with missing data were imputed as non-responders.||20.3|-9.0|
71048116|NCT04168190|141605286|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.99|||||TWO_SIDED|95.0|0.58|1.69|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 8||1.69|0.58|
71048117|NCT04168190|141605286|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.03|||||TWO_SIDED|95.0|0.57|1.85|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 9N||1.85|0.57|
71048118|NCT04168190|141605286|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.64|||||TWO_SIDED|95.0|0.9|2.97|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 9N||2.97|0.90|
71048119|NCT04168190|141605286|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.25|||||TWO_SIDED|95.0|0.67|2.32|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 10A||2.32|0.67|
71048120|NCT04168190|141605286|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.84|||||TWO_SIDED|95.0|0.98|3.45|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 10A||3.45|0.98|
71048121|NCT04168190|141605286|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.76|||||TWO_SIDED|95.0|0.42|1.38|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 11A||1.38|0.42|
71048122|NCT04168190|141605286|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.59|||||TWO_SIDED|95.0|0.87|2.91|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 11A||2.91|0.87|
71048123|NCT04168190|141605286|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.04|||||TWO_SIDED|95.0|0.5|2.17|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 12F||2.17|0.50|
71048124|NCT04168190|141605286|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|2.14|||||TWO_SIDED|95.0|1.02|4.5|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 12F||4.50|1.02|
70929089|NCT04587453|141354111|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Mean Difference (Net)|-4.3|||||TWO_SIDED|95.0|-14.9|6.3|||||Repeated measurements Model: Change=Treatment\*Week+Baseline\*Week+Baseline IGA. Data after permanent discontinuation of IMP/initiation of rescue medication not included (4 subjects excluded). Week 2 change imputed as 0 if no post-baseline assessments.|||6.3|-14.9|
70929090|NCT04587453|141354112|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.7|0.8|||||Repeated measurements Model: Change=Treatment\*Week+Baseline\*Week+Baseline IGA. Data after permanent discontinuation of IMP/initiation of rescue medication not included (4 subjects excluded). Week 2 change imputed as 0 if no post-baseline assessments.|||0.8|-0.7|
70929091|NCT04587453|141354113|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.9|0.6|||||Repeated measurements model: Change=Treatment\*Week+Baseline\*Week+Baseline IGA. Data after permanent discontinuation of IMP/initiation of rescue medication not included (4 subjects excluded). Week 1 change imputed as 0 if no post-baseline assessments.|||0.6|-0.9|
70929092|NCT04587453|141354114|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Mean Difference (Net)|-3.2|||||TWO_SIDED|95.0|-5.6|-0.9|||||Repeated measurements model: Change=Treatment\*Week+Baseline\*Week+Baseline IGA. Data after permanent discontinuation of IMP/initiation of rescue medication not included (4 subjects excluded). Week 2 change imputed as 0 if no post-baseline assessments.|||-0.9|-5.6|
70929093|NCT03125070|141354117|SUPERIORITY|||||||0.9||||||The threshold for statistical significance was p=0.05|Chi-squared|||||||0.90
70929094|NCT03125070|141354118|SUPERIORITY|||||||0.6||||||The threshold for statistical significance was p=0.05|Chi-squared|||||||0.60
70929095|NCT03125070|141354119|OTHER|||||||0.27||||||The threshold for statistical significance was p=0.05|Chi-squared|||Sex: Female vs. Male||||0.27
71013713|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.129|TWO_SIDED|95.0|-0.85|0.11|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.11|-0.85|0.129
71013714|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.096|TWO_SIDED|95.0|-1.07|0.09|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.09|-1.07|0.096
71013715|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.905|TWO_SIDED|95.0|-0.5|0.57|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.57|-0.50|0.905
71013716|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.279|TWO_SIDED|95.0|-0.77|0.22|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.22|-0.77|0.279
71013717|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.315|TWO_SIDED|95.0|-0.9|0.29|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.29|-0.90|0.315
71013718|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.203|TWO_SIDED|95.0|-0.19|0.91|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.91|-0.19|0.203
71013719|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.207|TWO_SIDED|95.0|-0.83|0.18|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.18|-0.83|0.207
71013720|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.03|TWO_SIDED|95.0|-1.3|-0.07|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.07|-1.30|0.030
71013721|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.372|TWO_SIDED|95.0|-0.32|0.84|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.84|-0.32|0.372
71013722|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.532|TWO_SIDED|95.0|-0.7|0.36|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.36|-0.70|0.532
70929096|NCT03125070|141354119|OTHER|||||||0.88||||||The threshold for statistical significance was p=0.05|Chi-squared|||Age \<70 vs. \>=70||||0.88
70929097|NCT03125070|141354119|OTHER|||||||0.98||||||The threshold for statistical significance was p=0.05|Chi-squared|Participants that did not answer this survey item are shown as unknwon in the table and are excluded from the statistical test.||Race and ethnicity: white AND non-Hispanic versus any other combination of race and ethnicity (BIPOC)||||0.98
70929098|NCT03125070|141354119|OTHER|||||||0.19||||||The threshold for statistical significance was p=0.05|Chi-squared|Participants that did not answer this survey item are shown as unknwon in the table and are excluded from the statistical test.||Education: High school or less versus at least some college or vocational/technical program||||0.19
70929099|NCT03125070|141354119|OTHER|||||||0.24||||||The threshold for statistical significance was p=0.05|Chi-squared|Participants that did not answer this survey item are shown as unknwon in the table and are excluded from the statistical test.||Income: \<$100,000 annual versus \>=$100,000 annual||||0.24
71048125|NCT04168190|141605286|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|2.11|||||TWO_SIDED|95.0|1.21|3.68|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 17F||3.68|1.21|
71048126|NCT04168190|141605286|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|2.87|||||TWO_SIDED|95.0|1.64|5.03|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 17F||5.03|1.64|
71048127|NCT04168190|141605286|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.65|||||TWO_SIDED|95.0|0.93|2.93|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 20A||2.93|0.93|
71048128|NCT04168190|141605286|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.92|||||TWO_SIDED|95.0|1.07|3.43|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 20A||3.43|1.07|
70850462|NCT01474239|141188992|SUPERIORITY_OR_OTHER|||||||0.4291|TWO_SIDED|||||Statistical significance was assessed with a one-sided alpha error of 10 percent (%).|Exact Binomial Test|||The 6-month OS rate (OS-6) for bevacizumab was compared to the expected proportion of 0.60 under null hypothesis (ineffective treatment) with the application of the exact binomial test. The one-tailed statistical hypotheses was p0 less than or equal to (≤) 0.60 (null hypothesis) versus pA greater than or equal to (≥) 0.77 (alternative hypothesis), where p is the estimated probability of survival at 6 months.||||0.4291
70850463|NCT00459732|141189014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|TWO_SIDED|95.0|||||ANOVA|||||||0.13
70850464|NCT00459732|141189015|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44|TWO_SIDED|95.0|||||ANOVA|Repeated measures||||||0.44
70850465|NCT00459732|141189016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|TWO_SIDED|95.0|||||ANCOVA|Repeated measures analysis of variance adjusted for baseline osteocalcin level.||||||0.16
70850466|NCT03983317|141189019|OTHER|We tested if the average drinks consumed was statistically different in Week 2 of the Treatment Phase vs. the Baseline Phase. This was evaluated via a paired t-test.||||||0.026|||||||t-test, 2 sided|Paired t-test||||||0.026
70850467|NCT03983317|141189021|OTHER|We tested if the average craving intensity was statistically different in Week 2 of the Treatment Phase vs. the Baseline Phase. This was evaluated via a paired t-test.||||||0.001|||||||t-test, 2 sided|Paired t-test||||||0.001
70850468|NCT04335136|141189091|OTHER|||||||0.5207||||||The level of significance was 5% (2-sided).|Chi-squared|||"Hypothesis tested: H0: pAPN01 = pPlacebo; H1: pAPN01 ≠ pPlacebo (with p=proportion of patients with event).~A total of 186 patients (93 per group) was estimated to yield 80% power to detect a 20% absolute risk reduction in the primary, from 50% in the placebo group to 30% in the APN01 group, at a 2-sided alpha of 0.05. To consider patients who would be randomized but not treated, a total of 200 patients (100 per group) were planned to be enrolled."||||0.5207
70850469|NCT04335136|141189091|OTHER||Odds Ratio (OR)|0.63||||0.3588|TWO_SIDED|95.0|0.23|1.7|||Regression, Logistic|Degree of freedom: 1||||1.70|0.23|0.3588
70850470|NCT01305577|141189109|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.73|||<|0.001|TWO_SIDED|95.0|2.7|8.28|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|The odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 1 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||8.28|2.70|<0.001
70850471|NCT01305577|141189109|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.21|||<|0.001|TWO_SIDED|95.0|3.52|10.94|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|The odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|The null hypothesis was there was no difference between deoxycholic acid 2 mg/cm² and placebo. An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme.||10.94|3.52|<0.001
70850472|NCT01305577|141189110|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.58||||0.028|TWO_SIDED|95.0|1.2|25.87|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|Odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|||25.87|1.20|0.028
70850473|NCT01305577|141189110|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.05|||<|0.001|TWO_SIDED|95.0|2.75|52.9|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|Odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|||52.90|2.75|<0.001
70850474|NCT01305577|141189111|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.99|||<|0.001|TWO_SIDED|95.0|1.74|5.14|||Regression, Logistic|Logistic regression analysis with treatment and Baseline SSRS value in the model|Odds ratio was based on a logistic regression model adjusted for Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 1 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||5.14|1.74|<0.001
71048129|NCT04168190|141605287|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|4.29|||||TWO_SIDED|95.0|1.99|9.25|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 6A||9.25|1.99|
71048130|NCT04168190|141605287|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|5.49|||||TWO_SIDED|95.0|2.53|11.91|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 6A||11.91|2.53|
71048131|NCT04168190|141605287|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|5.05|||||TWO_SIDED|95.0|2.59|9.85|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 15A||9.85|2.59|
71048132|NCT04168190|141605287|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|8.92|||||TWO_SIDED|95.0|4.55|17.5|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 15A||17.50|4.55|
70929100|NCT03125070|141354119|OTHER|||||||0.28||||||The threshold for statistical significance was p=0.05|Chi-squared|Participants that did not answer the survey items for this measure are shown as unknwon in the table and are excluded from the statistical test.||PHQ score at baseline: no depression (\<10), mild depression (10-14), moderate depression (15-19), severe depression (\>=20)||||0.28
70929101|NCT03125070|141354119|OTHER|||||||0.33||||||The threshold for statistical significance was p=0.05|Chi-squared|Participants that did not answer the survey items for this measure are shown as unknwon in the table and are excluded from the statistical test.||CTXD score at baseline \<0.9 (not distressed) or \>=0.9 (distressed)||||0.33
70929102|NCT03125070|141354119|OTHER|||||||0.1||||||The threshold for statistical significance was p=0.05|Chi-squared|Participants that did not answer this survey item are shown as unknwon in the table and are excluded from the statistical test.||Cardiometabolic Healthcare Utilization (HCU-C) score at baseline: \>.80 versus \<.80||||0.10
70929103|NCT03125070|141354119|OTHER|||||||0.31||||||The threshold for statistical significance was p=0.05|Chi-squared|||Secondary cancer screening healthcare utilization (HCU-SM) at baseline: \>=.80 versus \<.80||||0.31
70929104|NCT03125070|141354120|SUPERIORITY|||||||0.89|||||||Chi-squared|||||||0.89
70929105|NCT03125070|141354121|SUPERIORITY|||||||0.4|||||||Chi-squared|||||||0.40
70929106|NCT05086796|141354136|SUPERIORITY||Risk Ratio (RR)|2.1|||||TWO_SIDED|97.5|1.51|2.91|||||The START arm is the numerator, Usual Care is the denominator. There are two primary outcome measures, so the type I error level was adjusted to alpha = 0.025.||Poisson regression was used to compare the proportions of participants who initiated MOUD in the hospital by calculating the risk ratio (RR) and 97.5% confidence interval (CI) and with covariates treatment arm, site (3 sites), prior exposure to MOUD (yes vs. no), and length of hospital stay in days.|2.91|1.51|
70929107|NCT05086796|141354137|SUPERIORITY||Risk Ratio (RR)|1.49|||||TWO_SIDED|97.5|1.15|1.93|||||The START arm is the numerator, Usual Care is the denominator. There are two primary outcome measures, so the type I error level was adjusted to alpha = 0.025.||Poisson regression was used to compare the proportions of participants who linked to follow-up OUD care by calculating the risk ratio (RR) and 97.5% confidence interval (CI) and with covariates treatment arm, site (3 sites), and prior exposure to MOUD (yes vs. no).|1.93|1.15|
71013723|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.189|TWO_SIDED|95.0|-1.08|0.21|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.21|-1.08|0.189
71013724|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.264|TWO_SIDED|95.0|-0.24|0.87|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.87|-0.24|0.264
71013725|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.26|TWO_SIDED|95.0|-0.81|0.22|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 4 hour Day 1:The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.22|-0.81|0.260
71013726|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.054|TWO_SIDED|95.0|-1.23|0.01|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.01|-1.23|0.054
71013727|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.456|TWO_SIDED|95.0|-0.37|0.81|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.81|-0.37|0.456
71013728|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.639|TWO_SIDED|95.0|-0.42|0.68|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.68|-0.42|0.639
71013729|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.78|TWO_SIDED|95.0|-0.75|0.57|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.57|-0.75|0.780
71013730|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.071|TWO_SIDED|95.0|-0.04|1.07|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.07|-0.04|0.071
70929108|NCT05086796|141354138|SUPERIORITY||Risk Ratio (RR)|1.8|||||TWO_SIDED|95.0|1.35|2.41|||||The START arm is the numerator, Usual Care is the denominator.||Multivariable Poisson regression was used to compare the proportions of participants who initiated MOUD in the hospital between arms by calculating the risk ratio (RR) and 95% confidence interval (CI) with covariates: treatment arm, site (3 sites), and prior exposure to MOUD (yes vs. no).|2.41|1.35|
70929109|NCT05086796|141354139|SUPERIORITY||Risk Ratio (RR)|1.71|||||TWO_SIDED|95.0|1.23|2.39|||||The START arm is the numerator, Usual Care is the denominator.||Multivariable Poisson regression was used to compare the proportions of participants who reported any post-discharge MOUD utilization between arms by calculating the risk ratio (RR) and 95% confidence interval (CI) with covariates: treatment arm, site (3 sites), and prior exposure to MOUD (yes vs. no).|2.39|1.23|
70929110|NCT05086796|141354140|SUPERIORITY||Risk Ratio (RR)|1.89|||||TWO_SIDED|95.0|1.18|3.03|||||The START arm is the numerator, Usual Care is the denominator.||Multivariable Poisson regression was used to compare the proportions of participants who reported receiving any post-discharge outpatient medical care for their OUD between arms by calculating the risk ratio (RR) and 95% confidence interval (CI) with covariates: site (3 sites), and prior exposure to MOUD (yes vs. no).|3.03|1.18|
70929111|NCT05086796|141354141|SUPERIORITY||Incident rate ratio|1.25|||||TWO_SIDED|95.0|0.64|2.43|||||The START arm is the numerator, Usual Care is the denominator.||Multivariable negative binomial regression with a log link function was used to compare opioid use-days between the two treatment arms by calculating the incident rate ratio (IRR) and 95% confidence interval (CI) with covariates: site (3 sites), prior exposure to MOUD (yes vs. no), and baseline opioid use days.|2.43|0.64|
70929112|NCT04231331|141354155|SUPERIORITY||||||<|0.001||||||P-value \<0.05 was considered statistically significant.|t-test, 2 sided|||Based on our previous study, we assumed a common baseline mean EROA of 0.21 cm2 with a common standard deviation of 0.11 cm2. Given these assumptions, we calculated that a sample size of 204 patients randomly assigned to two groups, would provide 90% power to detect a difference of 0.05 cm2 in the EROA between the ertugliflozin and placebo groups, using a two-sided t test with an alpha level of 0.05.||||<0.001
70929113|NCT04484428|141354235|SUPERIORITY|||||||0.773|||||||ANCOVA|||||||0.773
70929114|NCT04484428|141354236|SUPERIORITY|||||||0.972|||||||ANCOVA|||||||0.972
70929115|NCT04484428|141354237|SUPERIORITY|||||||0.617|||||||ANCOVA|||||||0.617
71013731|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.468|TWO_SIDED|95.0|-0.7|0.32|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.32|-0.70|0.468
71013732|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.027|TWO_SIDED|95.0|-1.33|-0.08|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.08|-1.33|0.027
71013733|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.107|TWO_SIDED|95.0|-0.11|1.09|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.09|-0.11|0.107
71013734|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.947|TWO_SIDED|95.0|-0.57|0.53|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.53|-0.57|0.947
71013735|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.134|TWO_SIDED|95.0|-1.18|0.16|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.16|-1.18|0.134
71048133|NCT04168190|141605287|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|4.4|||||TWO_SIDED|95.0|2.38|8.15|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 15C||8.15|2.38|
71048134|NCT04168190|141605287|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|4.92|||||TWO_SIDED|95.0|2.64|9.16|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 15C||9.16|2.64|
71048135|NCT04168190|141605287|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|3.41|||||TWO_SIDED|95.0|1.97|5.91|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 16F||5.91|1.97|
71048136|NCT04168190|141605287|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|6.58|||||TWO_SIDED|95.0|3.78|11.45|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 16F||11.45|3.78|
71048137|NCT04168190|141605287|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|9.42|||||TWO_SIDED|95.0|4.35|20.4|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 23A||20.40|4.35|
71048138|NCT04168190|141605287|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|9.46|||||TWO_SIDED|95.0|4.34|20.62|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 23A||20.62|4.34|
70929116|NCT04484428|141354238|SUPERIORITY|||||||0.796|||||||ANCOVA|||||||0.796
70929117|NCT04484428|141354239|SUPERIORITY|||||||0.96|||||||ANCOVA|||||||0.960
70929118|NCT04484428|141354240|SUPERIORITY|||||||0.761|||||||ANCOVA|||||||0.761
70929119|NCT04484428|141354241|SUPERIORITY|||||||0.979|||||||ANCOVA|||||||0.979
70929120|NCT04484428|141354242|SUPERIORITY|||||||0.803|||||||ANCOVA|||||||0.803
70929121|NCT03825588|141354253|SUPERIORITY|||||||0.71||||||False Discovery Rate q-value \> 0.99|Chi-squared|||Compare participants receiving ASAP (ASAP+TAU and ASAP+BRITE+TAU) to those who do not (BRITE+TAU and TAU) on the rate of actual suicide attempts||||0.71
70929122|NCT03825588|141354253|SUPERIORITY|||||||0.43||||||False Discovery Rate q-vale \> 0.99|Chi-squared|||Compare participants receiving BRITE (BRITE+TAU and ASAP+BRITE+TAU) to those who do not (ASAP+TAU and TAU) on the rate of actual suicide attempts||||0.43
70929123|NCT03825588|141354253|SUPERIORITY||Odds Ratio (OR)|0.4||||0.21|TWO_SIDED|95.0|0.1|1.66||False Discovery Rate q-value \> 0.99|Regression, Logistic|||Compare the 4 arms on the rate of actual suicide attempts in a 2x2 factorial design. Interaction effect of ASAP and BRITE.||1.66|0.10|0.21
70929124|NCT03825588|141354253|SUPERIORITY||Odds Ratio (OR)|1.31||||0.57|TWO_SIDED|95.0|0.51|3.34||False Discovery Rate q-value \> 0.99|Regression, Logistic|||Compare the 4 arms on the rate of actual suicide attempts in a 2x2 factorial design. Main effect of ASAP||3.34|0.51|0.57
70929125|NCT03825588|141354253|SUPERIORITY||Odds Ratio (OR)|1.15||||0.77|TWO_SIDED|95.0|0.44|2.97||False Discovery Rate q-value \> 0.99|Regression, Logistic|||Compare the 4 arms on the rate of actual suicide attempts in a 2x2 factorial design. Main effect of BRITE.||2.97|0.44|0.77
71048139|NCT04168190|141605287|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|3.43|||||TWO_SIDED|95.0|1.95|6.05|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 23B||6.05|1.95|
71048140|NCT04168190|141605287|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|4.77|||||TWO_SIDED|95.0|2.69|8.45|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 23B||8.45|2.69|
71048141|NCT04168190|141605287|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|8.06|||||TWO_SIDED|95.0|3.36|19.35|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 24F||19.35|3.36|
71048142|NCT04168190|141605287|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|16.14|||||TWO_SIDED|95.0|6.68|39.01|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 24F||39.01|6.68|
71048143|NCT04168190|141605287|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|9.14|||||TWO_SIDED|95.0|4.93|16.95|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 31||16.95|4.93|
71048144|NCT04168190|141605287|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|13.58|||||TWO_SIDED|95.0|7.28|25.32|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 31||25.32|7.28|
71048145|NCT04168190|141605287|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|9.24|||||TWO_SIDED|95.0|5.56|15.36|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 35B||15.36|5.56|
71048146|NCT04168190|141605287|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|12.5|||||TWO_SIDED|95.0|7.49|20.87|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 35B||20.87|7.49|
70929126|NCT03825588|141354253|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.74|TWO_SIDED|95.0|0.48|1.69||False Discovery Rate q-value \> 0.99|Regression, Cox|||Compare participants receiving ASAP (ASAP+TAU and ASAP+BRITE+TAU) to those who do not (BRITE+TAU and TAU) on time to actual suicide attempt||1.69|0.48|0.74
71048147|NCT04168190|141605288|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.99|||||TWO_SIDED|95.0|0.67|1.47|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 3||1.47|0.67|
70929127|NCT03825588|141354253|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.45|TWO_SIDED|95.0|0.42|1.48||False Discovery Rate q-vale \> 0.99|Regression, Cox|||Compare participants receiving BRITE (BRITE+TAU and ASAP+BRITE+TAU) to those who do not (ASAP+TAU and TAU) on the time to actual suicide attempt||1.48|0.42|0.45
70929128|NCT03825588|141354253|SUPERIORITY||Hazard Ratio (HR)|0.47||||0.25|TWO_SIDED|95.0|0.13|1.72||False Discovery Rate q-value \> 0.99|Regression, Cox|||Compare the 4 arms on time to actual suicide attempt in a 2x2 factorial design. Interaction effect of ASAP and BRITE||1.72|0.13|0.25
70929129|NCT03825588|141354253|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.62|TWO_SIDED|95.0|0.54|2.87||False Discovery Rate q-value \> 0.99|Regression, Cox|||Compare the 4 arms on time to actual suicide attempt in a 2x2 factorial design. Main effect of ASAP.||2.87|0.54|0.62
71048148|NCT04168190|141605288|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.06|||||TWO_SIDED|95.0|0.72|1.57|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 3||1.57|0.72|
71048149|NCT04168190|141605288|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.88||||||95.0|0.54|1.42|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 7F||1.42|0.54|
71048150|NCT04168190|141605288|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.11|||||TWO_SIDED|95.0|0.68|1.8|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 7F||1.80|0.68|
71048151|NCT04168190|141605288|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.59|1.54|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 19A||1.54|0.59|
70929130|NCT03825588|141354253|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.83|TWO_SIDED|95.0|0.47|2.59||False Discovery Rate q-value \> 0.99|Regression, Cox|||Compare the 4 arms on time to actual suicide attempt in a 2x2 factorial design. Main effect of BRITE.||2.59|0.47|0.83
71013736|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.017|TWO_SIDED|95.0|0.12|1.23|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.23|0.12|0.017
71013737|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.715|TWO_SIDED|95.0|-0.6|0.41|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.41|-0.60|0.715
71013738|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8||||0.015|TWO_SIDED|95.0|-1.39|-0.15|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.15|-1.39|0.015
71013739|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.027|TWO_SIDED|95.0|0.07|1.23|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.23|0.07|0.027
71048152|NCT04168190|141605288|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.32|||||TWO_SIDED|95.0|0.81|2.15|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 19A||2.15|0.81|
71048153|NCT04168190|141605288|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.65|||||TWO_SIDED|95.0|0.85|3.23|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 22F||3.23|0.85|
71048154|NCT04168190|141605288|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|2.01|||||TWO_SIDED|95.0|1.03|3.96|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 22F||3.96|1.03|
71048155|NCT04168190|141605288|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.86|||||TWO_SIDED|95.0|0.44|1.67|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 33F||1.67|0.44|
71048156|NCT04168190|141605288|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.89|||||TWO_SIDED|95.0|0.97|3.69|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 33F||3.69|0.97|
71048157|NCT04168190|141605288|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.46|1.08|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 8||1.08|0.46|
71048158|NCT04168190|141605288|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.89|||||TWO_SIDED|95.0|0.58|1.38|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 8||1.38|0.58|
71048159|NCT04168190|141605288|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.15|||||TWO_SIDED|95.0|0.62|2.15|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 9N||2.15|0.62|
71048160|NCT04168190|141605288|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.09|||||TWO_SIDED|95.0|0.58|2.04|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 9N||2.04|0.58|
71048161|NCT04168190|141605288|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.56|||||TWO_SIDED|95.0|0.9|2.71|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 10A||2.71|0.90|
71048162|NCT04168190|141605288|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.87|||||TWO_SIDED|95.0|1.08|3.23|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 10A||3.23|1.08|
71048163|NCT04168190|141605288|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.89|||||TWO_SIDED|95.0|0.53|1.49|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 11A||1.49|0.53|
71048164|NCT04168190|141605288|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.11|||||TWO_SIDED|95.0|0.66|1.87|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 11A||1.87|0.66|
70850475|NCT01305577|141189111|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.22|||<|0.001|TWO_SIDED|95.0|2.99|9.11|||Regression, Logistic|Logistic regression analysis with treatment and baseline SSRS value in the model|Odds ratio was based on a logistic regression model adjusted for Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 2 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||9.11|2.99|<0.001
71048165|NCT04168190|141605288|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.7|||||TWO_SIDED|95.0|0.89|3.27|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 12F||3.27|0.89|
71048166|NCT04168190|141605288|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|2.4|||||TWO_SIDED|95.0|1.24|4.62|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 12F||4.62|1.24|
71048167|NCT04168190|141605288|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.97|||||TWO_SIDED|95.0|1.16|3.34|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 17F||3.34|1.16|
71048168|NCT04168190|141605288|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|2.06|||||TWO_SIDED|95.0|1.21|3.51|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 17F||3.51|1.21|
71048169|NCT04168190|141605288|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.22|||||TWO_SIDED|95.0|0.77|1.91|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 20A||1.91|0.77|
71048170|NCT04168190|141605288|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.56|||||TWO_SIDED|95.0|0.99|2.45|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 20A||2.45|0.99|
71048171|NCT04168190|141605289|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|13.98|||||TWO_SIDED|95.0|5.9|33.1|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 6A||33.10|5.90|
71048172|NCT04168190|141605289|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|14.42|||||TWO_SIDED|95.0|6.05|34.35|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 6A||34.35|6.05|
71048173|NCT04168190|141605289|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|7.39||||||95.0|4.29|12.75|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 15A||12.75|4.29|
71048174|NCT04168190|141605289|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|9.4|||||TWO_SIDED|95.0|5.42|16.28|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 15A||16.28|5.42|
70929131|NCT03825588|141354254|SUPERIORITY|||||||0.19||||||False Discovery Rate q-value = 0.72|Chi-squared|||Compare participants receiving ASAP (ASAP+TAU and ASAP+BRITE+TAU) to those who do not (BRITE+TAU and TAU) on the rate of suicidal events|We used standard univariate statistics to compare partici- pants' baseline sociodemographics and clinical characteris- tics by arm \[(ASAP vs No ASAP where comparison is 6 www.jaacap.org (ASAP+TAU) and (ASAP+BRITE+TAU) vs (TAU alone) and (BRITE+TAU); and BRITE vs No BRITE where comparison is (ASAP+BRITE+TAU) and (BRITE+TAU) vs (ASAP+TAU) and (TAU Alone)\], site, retention, pre- post-COVID and recruitment venue. We then tested for equality of the 2 cells (ASAP vs no ASAP, BRITE vs no BRITE) or 4 cells (ASAP+BRITE+TAU vs BRITE +TAU vs ASAP+TAU vs TAU Alone) without covariates on the rates of and time to suicidal behavior using the appropriate (t or F, c2, Kaplan-Meier, Cox models) test statistics. We then used mixed-effects regression models with arm (2 and 4 cells), time, and their interaction for continuous data. Presented percentages are based on all observed data.|||0.19
71013740|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.66|TWO_SIDED|95.0|-0.42|0.65|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.65|-0.42|0.660
71013741|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.107|TWO_SIDED|95.0|-1.18|0.11|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.11|-1.18|0.107
71013742|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.02|TWO_SIDED|95.0|0.1|1.13|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.13|0.10|0.020
71013743|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.749|TWO_SIDED|95.0|-0.55|0.4|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.40|-0.55|0.749
71013744|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.019|TWO_SIDED|95.0|-1.27|-0.12|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.12|-1.27|0.019
71013745|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.163|TWO_SIDED|95.0|-0.16|0.96|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.96|-0.16|0.163
71013746|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.727|TWO_SIDED|95.0|-0.43|0.61|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.61|-0.43|0.727
71013747|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.336|TWO_SIDED|95.0|-0.94|0.32|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.32|-0.94|0.336
71013748|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.174|TWO_SIDED|95.0|-0.16|0.87|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.87|-0.16|0.174
71013749|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.277|TWO_SIDED|95.0|-0.73|0.21|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.21|-0.73|0.277
70850476|NCT01305577|141189112|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.51|||<|0.001|TWO_SIDED|95.0|-0.68|-0.35|||Mixed Models Repeated Measures|The model included the fixed effect factors visit and treatment, the visit\*treatment interaction, and the baseline CR-SMFRS values as covariate.||||-0.35|-0.68|<0.001
71013750|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.035|TWO_SIDED|95.0|-1.19|-0.04|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.04|-1.19|0.035
71013751|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.858|TWO_SIDED|95.0|-0.5|0.6|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.60|-0.50|0.858
71013752|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.724|TWO_SIDED|95.0|-0.6|0.42|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.42|-0.60|0.724
71013753|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.651|TWO_SIDED|95.0|-0.76|0.48|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.48|-0.76|0.651
70929132|NCT03825588|141354254|SUPERIORITY|||||||0.89|TWO_SIDED|95.0||||False Discovery Rate q-value \> 0.99|Chi-squared|||Compare participants receiving BRITE (BRITE+TAU and ASAP+BRITE+TAU) to those who do not (ASAP+TAU and TAU) on the rate of suicidal events||||0.89
71013754|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.059|TWO_SIDED|95.0|-0.02|1.05|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.05|-0.02|0.059
70850477|NCT01305577|141189112|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.67|||<|0.001|TWO_SIDED|95.0|-0.84|-0.5|||Mixed Models Repeated Measures|The model included the fixed effect factors visit and treatment, the visit\*treatment interaction, and the baseline CR-SMFRS values as covariate.||||-0.50|-0.84|<0.001
71013755|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.766|TWO_SIDED|95.0|-0.57|0.42|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.42|-0.57|0.766
71013756|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.053|TWO_SIDED|95.0|-1.19|0.01|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.01|-1.19|0.053
71013757|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.212|TWO_SIDED|95.0|-0.21|0.92|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.92|-0.21|0.212
71013758|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.911|TWO_SIDED|95.0|-0.49|0.55|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.55|-0.49|0.911
71013759|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.305|TWO_SIDED|95.0|-0.96|0.3|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.30|-0.96|0.305
71013760|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.075|TWO_SIDED|95.0|-0.05|1.02|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.02|-0.05|0.075
71013761|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.684|TWO_SIDED|95.0|-0.39|0.6|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.60|-0.39|0.684
71013762|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.208|TWO_SIDED|95.0|-0.98|0.21|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.21|-0.98|0.208
71013763|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.304|TWO_SIDED|95.0|-0.27|0.85|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.85|-0.27|0.304
70929133|NCT03825588|141354254|SUPERIORITY||Odds Ratio (OR)|0.35||||0.08|TWO_SIDED|95.0|0.11|1.1||False Discovery Rate q-value = 0.72|Regression, Logistic|||Compare participants the 4 arms on the rate of suicidal events in a 2x2 factorial design. Interaction effect of ASAP and BRITE.||1.10|0.11|0.08
71013764|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.356|TWO_SIDED|95.0|-0.27|0.76|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.76|-0.27|0.356
71048175|NCT04168190|141605289|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|2.13|||||TWO_SIDED|95.0|1.25|3.63|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 15C||3.63|1.25|
71048176|NCT04168190|141605289|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|2.8|||||TWO_SIDED|95.0|1.64|4.79|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 15C||4.79|1.64|
71048177|NCT04168190|141605289|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|3.79|||||TWO_SIDED|95.0|1.88|7.67|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 16F||7.67|1.88|
71013765|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.876|TWO_SIDED|95.0|-0.67|0.58|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.58|-0.67|0.876
71013766|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.02|TWO_SIDED|95.0|0.1|1.15|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.15|0.10|0.020
70929134|NCT03825588|141354254|SUPERIORITY||Odds Ratio (OR)|1.14||||0.74|TWO_SIDED|95.0|0.51|2.55||False Discovery Rate q \> 0.99|Regression, Logistic|||Compare the 4 arms on time to actual suicide attempt in a 2x2 factorial design. Main effect of ASAP.||2.55|0.51|0.74
70929135|NCT03825588|141354254|SUPERIORITY||Odds Ratio (OR)|1.69||||0.19|TWO_SIDED|95.0|0.77|3.69||False Discovery Rate q=0.72|Regression, Logistic|||Compare the 4 arms on time to actual suicide attempt in a 2x2 factorial design. Main effect of BRITE.||3.69|0.77|0.19
70929136|NCT06149338|141354260|SUPERIORITY|||||||0.0002||||||Threshold for statistical significance: p \< 0.05|Chi-squared|||||||0.0002
70929137|NCT06149338|141354260|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
70929138|NCT06149338|141354261|SUPERIORITY||||||<|0.0001||||||Threshold for statistical significance: p \< 0.05|Kruskal-Wallis|||||||< 0.0001
70929139|NCT06149338|141354262|SUPERIORITY|||||||0.0041||||||Threshold for statistical significance: p \< 0.05|Chi-squared|||||||0.0041
70929140|NCT06149338|141354262|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
70929141|NCT06149338|141354263|SUPERIORITY|||||||0.7895||||||Threshold for statistical significance: p \< 0.05|Kruskal-Wallis|||||||0.7895
70929142|NCT02038777|141354280|OTHER||||||<|0.0001||||||An exact test for a single proportion (1-sided significance level: 0.05) was used.|Exact test for a single proportion|||||||<.0001
70929143|NCT03643744|141354388|SUPERIORITY|||||||0.53|||||||ANOVA|||||||0.530
70929144|NCT03643744|141354388|SUPERIORITY|||||||0.727|||||||ANOVA|||||||0.727
70929145|NCT03643744|141354389|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
70929146|NCT04487860|141354391|SUPERIORITY|||||||0.7905|||||||ANCOVA|||||||0.7905
70929147|NCT04487860|141354391|SUPERIORITY|||||||0.7372|||||||ANCOVA|||||||0.7372
70929148|NCT04487860|141354391|SUPERIORITY|||||||0.2989|||||||ANCOVA|||||||0.2989
70929149|NCT04487860|141354391|SUPERIORITY|||||||0.3328|||||||ANCOVA|||||||0.3328
70929150|NCT04487860|141354392|SUPERIORITY|||||||0.8989|||||||ANCOVA|||||||0.8989
70929151|NCT04487860|141354392|SUPERIORITY|||||||0.6768|||||||ANCOVA|||||||0.6768
70929152|NCT04487860|141354392|SUPERIORITY|||||||0.8209|||||||ANCOVA|||||||0.8209
70929153|NCT04487860|141354392|SUPERIORITY|||||||0.3106|||||||ANCOVA|||||||0.3106
70929154|NCT04487860|141354393|SUPERIORITY|||||||0.8593|||||||ANCOVA|||||||0.8593
70929155|NCT04487860|141354393|SUPERIORITY|||||||0.9594|||||||ANCOVA|||||||0.9594
70929156|NCT04487860|141354393|SUPERIORITY|||||||0.9041|||||||ANCOVA|||||||0.9041
70929157|NCT04487860|141354393|SUPERIORITY|||||||0.7147|||||||ANCOVA|||||||0.7147
70929158|NCT05163496|141354400|SUPERIORITY||Mean Difference (Net)|12.0|STANDARD_DEVIATION|0.8|<|0.001|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis was that the mean change in MADRS score from the preparation 1 session to day 28 would be the same in both niacin and psilocybin groups. The alternative hypothesis was that the change in the psilocybin group would be greater than the change in the niacin group, with an assumed true effect size of 1.06 SD units based on findings in prior studies. With 15 participants per group, this study had 80% power to observe a statistically significant difference between groups.||||<.001
70929159|NCT04685135|141354463|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.45|0.76|||Log Rank|HR and CI are from stratified Cox proportional hazard model||||0.76|0.45|<0.0001
70929160|NCT04685135|141354465|SUPERIORITY||Odds Ratio (OR)|4.68|||<|0.0001|TWO_SIDED|95.0|2.56|8.56|||Cochran Mantel Haenszel chi-square test|||||8.56|2.56|<0.0001
70929161|NCT04911296|141354540|OTHER|||||||0.935|||||||Fisher Exact|||||||0.935
70929162|NCT04911296|141354541|OTHER|||||||0.536|||||||Fisher Exact|||||||0.536
70929163|NCT03295721|141354615|SUPERIORITY||Least Squares Mean Difference (LSMD)|-122.05|STANDARD_ERROR_OF_MEAN|21.217|<|0.0001|TWO_SIDED|95.0|-163.76|-80.34|||ANOVA|||||-80.34|-163.76|< 0.0001
70929164|NCT03295721|141354616|SUPERIORITY||Least Squares Mean Difference (LSMD)|-70.16|STANDARD_ERROR_OF_MEAN|18.777|=|0.0002|TWO_SIDED|95.0|-107.07|-33.25|||ANOVA|||||-33.25|-107.07|= 0.0002
70929165|NCT03295721|141354617|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
70929166|NCT03295721|141354618|SUPERIORITY||Risk Difference (RD)|0.177||||0.0001|TWO_SIDED|95.0|0.085|0.265|||Fisher Exact|||||.265|.085|0.0001
70929167|NCT03295721|141354619|SUPERIORITY||||||=|0.0022|||||||Wilcoxon (Mann-Whitney)|||||||= 0.0022
70929168|NCT04047602|141354650|EQUIVALENCE|The observed proportion of evaluable patients with symptomatic radiation necrosis was calculated and tested against a baseline 6-month symptomatic radiation necrosis rate of 16% at a type I error rate of 5% using a one-sided binomial exact test. The null hypothesis is that the observed proportion is equivalent to 16% or 0.160.|Binomial Proportion|0.083||||0.234|TWO_SIDED|95.0|0.002|0.385||The p-value reported is the one-sided p-value from the exact equivalence binomial test using an alpha value of 0.05.|Exact Binomial Test||The binomial proportion 95% confidence intervals were calculated using the Clopper-Pearson (Exact) method.|The observed proportion of evaluable patients with symptomatic radiation necrosis was calculated and tested against a baseline 6-month symptomatic radiation necrosis rate of 16% at a type I error rate of 5% using a one-sided binomial exact test. The null hypothesis is that the observed proportion is equivalent to 16% or 0.160.||0.385|0.002|0.234
70929169|NCT04047602|141354653|OTHER|||||||0.285|||||||Klein Method|||The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across SRS groups. The null hypothesis was that the survival probabilities were equal.||||0.285
70929170|NCT04047602|141354654|OTHER|||||||0.292|||||||Klein Method|||The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across brain metastases groups. The null hypothesis was that the survival probabilities were equal.||||0.292
70929171|NCT04047602|141354655|OTHER|||||||0.289|||||||Klein Method|||The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across ICI groups. The null hypothesis was that the survival probabilities were equal.||||0.289
70929172|NCT04047602|141354658|OTHER|||||||0.248|||||||Klein Method|||The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across SRS groups. The null hypothesis was that the survival probabilities were equal.||||0.248
70929173|NCT04047602|141354659|OTHER|||||||0.292|||||||Klein Method|||The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across brain metastases groups. The null hypothesis was that the survival probabilities were equal.||||0.292
70929174|NCT04047602|141354660|OTHER|||||||0.289|||||||Klein Method|||The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across ICI groups. The null hypothesis was that the survival probabilities were equal.||||0.289
70929175|NCT00661141|141354672|SUPERIORITY|||||||0.8727||||||Overall p-value testing cohort difference from ANOVA|ANOVA|||1.0 mg/kg Cohort, 3.0 mg/kg cohort, 5.0 mg/kg cohort||||0.8727
70929176|NCT00661141|141354675|SUPERIORITY|||||||0.0023||||||Overall p-value testing cohort difference from ANOVA|ANOVA|||1.0 mg/kg Cohort, 3.0 mg/kg cohort, 5.0 mg/kg cohort||||0.0023
71013767|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.94|TWO_SIDED|95.0|-0.5|0.47|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.47|-0.50|0.940
71013768|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.032|TWO_SIDED|95.0|-1.23|-0.06|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.06|-1.23|0.032
71013769|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.206|TWO_SIDED|95.0|-0.21|0.95|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.95|-0.21|0.206
71013770|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.31|TWO_SIDED|95.0|-0.26|0.81|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(AM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.81|-0.26|0.310
71013771|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.771|TWO_SIDED|95.0|-0.74|0.55|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(AM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.55|-0.74|0.771
71013772|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean difference|0.7||||0.016|TWO_SIDED|95.0|0.13|1.24|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.24|0.13|0.016
71048178|NCT04168190|141605289|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|5.87|||||TWO_SIDED|95.0|2.88|11.94|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 16F||11.94|2.88|
71048179|NCT04168190|141605289|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|13.76|||||TWO_SIDED|95.0|5.68|33.32|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 23A||33.32|5.68|
71048180|NCT04168190|141605289|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|19.28|||||TWO_SIDED|95.0|7.91|47.0|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 23A||47.00|7.91|
71048181|NCT04168190|141605289|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|23.85|||||TWO_SIDED|95.0|8.64|65.82|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 23B||65.82|8.64|
71013773|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.905|TWO_SIDED|95.0|-0.48|0.54|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.54|-0.48|0.905
71013774|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.039|TWO_SIDED|95.0|-1.28|-0.03|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.03|-1.28|0.039
71013775|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.276|TWO_SIDED|95.0|-0.27|0.93|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.93|-0.27|0.276
71048182|NCT04168190|141605289|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|39.39|||||TWO_SIDED|95.0|14.15|109.65|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 23B||109.65|14.15|
71048183|NCT04168190|141605289|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|19.88|||||TWO_SIDED|95.0|9.03|43.74|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 24F||43.74|9.03|
71048184|NCT04168190|141605289|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|31.07|||||TWO_SIDED|95.0|13.98|69.03|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 24F||69.03|13.98|
71048185|NCT04168190|141605289|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|57.79|||||TWO_SIDED|95.0|25.15|132.78|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 31||132.78|25.15|
70929177|NCT00661141|141354675|SUPERIORITY|||||||0.386||||||P-values for pairwise comparison between cohorts from ANOVA|ANOVA|||1.0 mg/kg Cohort, 3.0 mg/kg cohort||||0.386
70929178|NCT00661141|141354675|SUPERIORITY|||||||0.0006||||||P-values for pairwise comparison between cohorts from ANOVA|ANOVA|||1.0 mg/kg, 5.0 mg/kg||||0.0006
70929179|NCT00661141|141354675|SUPERIORITY|||||||0.0154||||||P-values for pairwise comparison between cohorts from ANOVA|ANOVA|||3.0 mg/kg, 5.0 mg/kg||||0.0154
71048186|NCT04168190|141605289|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|58.07|||||TWO_SIDED|95.0|25.1|134.33|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 31||134.33|25.10|
71048187|NCT04168190|141605289|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|6.93|||||TWO_SIDED|95.0|4.45|10.8|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 35B||10.80|4.45|
71048188|NCT04168190|141605289|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|7.82|||||TWO_SIDED|95.0|5.0|12.24|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 35B||12.24|5.00|
71048189|NCT04168190|141605292|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.9|1.3|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 3. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.30|0.90|<0.001
71048190|NCT04168190|141605292|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.23|||<|0.001|TWO_SIDED|95.0|0.99|1.52|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 7F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.52|0.99|<0.001
71048191|NCT04168190|141605292|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.24|||<|0.001|TWO_SIDED|95.0|1.02|1.52|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 19A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.52|1.02|<0.001
71048192|NCT04168190|141605292|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.36|||<|0.001|TWO_SIDED|95.0|1.06|1.75|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 22F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.75|1.06|<0.001
71048193|NCT04168190|141605292|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.86|||<|0.001|TWO_SIDED|95.0|0.69|1.06|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 33F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.06|0.69|<0.001
70929180|NCT00661141|141354682|SUPERIORITY||ratio of parameter means|115.57|||||TWO_SIDED|90.0|90.45|147.67|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||147.67|90.45|
71048194|NCT04168190|141605292|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.78|1.18|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 8. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.18|0.78|<0.001
71048195|NCT04168190|141605292|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.3|||<|0.001|TWO_SIDED|95.0|1.04|1.64|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 9N. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.64|1.04|<0.001
70850478|NCT01305577|141189113|SUPERIORITY_OR_OTHER||LS Mean Difference|1.04|||<|0.001|TWO_SIDED|95.0|0.61|1.47|||ANCOVA|The model includes the fixed effect factor treatment and the Baseline values as covariate.||||1.47|0.61|<0.001
70929181|NCT00661141|141354682|SUPERIORITY||ratio of parameter means|126.05|||||TWO_SIDED|90.0|101.94|155.87|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||155.87|101.94|
70929182|NCT00661141|141354682|SUPERIORITY||ratio of parameter means|137.58|||||TWO_SIDED|90.0|115.66|163.65|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||163.65|115.66|
71048196|NCT04168190|141605292|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.83|||<|0.001|TWO_SIDED|95.0|1.44|2.32|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 10A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.32|1.44|<0.001
70929183|NCT00661141|141354682|SUPERIORITY||ratio of parameter means|82.4|||||TWO_SIDED|90.0|62.83|108.07|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||108.07|62.83|
71048197|NCT04168190|141605292|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.54|||<|0.001|TWO_SIDED|95.0|1.27|1.86|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 11A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.86|1.27|<0.001
71048198|NCT04168190|141605292|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|2.3|||<|0.001|TWO_SIDED|95.0|1.75|3.04|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 12F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||3.04|1.75|<0.001
71048199|NCT04168190|141605292|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.82|||<|0.001|TWO_SIDED|95.0|1.49|2.22|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 17F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.22|1.49|<0.001
71048200|NCT04168190|141605292|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|2.27|||<|0.001|TWO_SIDED|95.0|1.81|2.83|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 20A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.83|1.81|<0.001
71048201|NCT04168190|141605293|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|3.77|||<|0.001|TWO_SIDED|95.0|2.95|4.84|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 6A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||4.84|2.95|<0.001
71048202|NCT04168190|141605293|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|7.68|||<|0.001|TWO_SIDED|95.0|6.12|9.64|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 15A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||9.64|6.12|<0.001
71048203|NCT04168190|141605293|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|3.29|||<|0.001|TWO_SIDED|95.0|2.6|4.17|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 15C. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||4.17|2.60|<0.001
71048204|NCT04168190|141605293|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|8.65|||<|0.001|TWO_SIDED|95.0|7.19|10.41|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 16F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||10.41|7.19|<0.001
71048205|NCT04168190|141605293|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|7.83|||<|0.001|TWO_SIDED|95.0|6.2|9.9|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 23A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model||9.90|6.20|<0.001
71104220|NCT03537508|141715470|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|7.83|||||TWO_SIDED|95.0|5.31|10.96||||||Statistical analysis for Serogroup C||10.96|5.31|
71048206|NCT04168190|141605293|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|5.61|||<|0.001|TWO_SIDED|95.0|4.53|6.94|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 23B. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||6.94|4.53|<0.001
71048207|NCT04168190|141605293|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|23.99|||<|0.001|TWO_SIDED|95.0|19.35|29.74|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 24F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||29.74|19.35|<0.001
71048208|NCT04168190|141605293|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|10.13|||<|0.001|TWO_SIDED|95.0|8.32|12.33|||P-value was estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 31. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||12.33|8.32|<0.001
71104221|NCT03537508|141715470|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|6.53|||||TWO_SIDED|95.0|4.01|9.62||||||Statistical analysis for Serogroup Y||9.62|4.01|
71048209|NCT04168190|141605293|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|18.29|||<|0.001|TWO_SIDED|95.0|15.59|21.45|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 35B. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||21.45|15.59|<0.001
71104222|NCT03537508|141715470|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|5.72|||||TWO_SIDED|95.0|3.44|8.57||||||Statistical analysis for Serogroup W||8.57|3.44|
71104223|NCT04983979|141715494|OTHER||Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.752|0.552||||||Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||0.552|-0.752|
71013776|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.343|TWO_SIDED|95.0|-0.29|0.82|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.82|-0.29|0.343
71013777|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.849|TWO_SIDED|95.0|-0.73|0.6|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.60|-0.73|0.849
71013778|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.009|TWO_SIDED|95.0|0.19|1.29|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.29|0.19|0.009
71013779|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.763|TWO_SIDED|95.0|-0.58|0.43|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.43|-0.58|0.763
71013780|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8||||0.01|TWO_SIDED|95.0|-1.43|-0.2|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.20|-1.43|0.010
71013781|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.105|TWO_SIDED|95.0|-0.1|1.09|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.09|-0.10|0.105
71013782|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.533|TWO_SIDED|95.0|-0.38|0.73|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.73|-0.38|0.533
71048210|NCT00876018|141605322|OTHER|||||||0.004||95.0|||||Mann Whitney U test|||||||0.004
71104224|NCT04983979|141715495|OTHER||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-1.97|0.65|||||Only the mean difference for the study end (week 12) is presented here|Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||0.65|-1.97|
70850479|NCT01305577|141189113|SUPERIORITY_OR_OTHER||LS Mean Difference|1.41|||<|0.001|TWO_SIDED|95.0|0.99|1.84|||ANCOVA|The model includes the fixed effect factor treatment and the Baseline values as covariate.||||1.84|0.99|<0.001
71013783|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.348|TWO_SIDED|95.0|-0.99|0.35|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.35|-0.99|0.348
71013784|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.016|TWO_SIDED|95.0|0.13|1.23|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.23|0.13|0.016
71013785|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.483|TWO_SIDED|95.0|-0.69|0.33|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.33|-0.69|0.483
71048211|NCT00876018|141605322|OTHER|||||||0.147||95.0|||||Mann Whitney U test|||||||0.147
71048212|NCT00876018|141605323|OTHER|||||||0.002||95.0|||||Mann Whitney U test|||||||0.002
71048213|NCT00876018|141605323|OTHER|||||||0.003||95.0|||||Mann Whitney U test|||||||0.003
71048214|NCT00876018|141605324|OTHER|||||||0.153||95.0|||||Mann Whitney U test|||||||0.153
71104225|NCT04983979|141715496|OTHER||Mean Difference (Final Values)|25.15|||||TWO_SIDED|95.0|-48.83|99.13|||||Difference in change in systolic blood pressure between study arms.|Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||99.13|-48.83|
71104226|NCT04983979|141715496|OTHER||Mean Difference (Final Values)|8.78|||||TWO_SIDED|95.0|-22.92|40.47|||||Difference in change in diastolic blood pressure between study arms.|Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||40.47|-22.92|
71104227|NCT04983979|141715497|OTHER||Risk Difference (RD)|0.25|||||TWO_SIDED|95.0|-0.174|0.674||||||Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||0.674|-0.174|
70929184|NCT00661141|141354682|SUPERIORITY||ratio of parameter means|115.25|||||TWO_SIDED|90.0|91.19|145.67|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included.||145.67|91.19|
70929185|NCT00661141|141354682|SUPERIORITY||ratio of parameter means|112.64|||||TWO_SIDED|90.0|96.14|131.98|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analyses for Cohort 3 where all available data were included.||131.98|96.14|
71013786|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9||||0.006|TWO_SIDED|95.0|-1.47|-0.25|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.25|-1.47|0.006
71013787|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.177|TWO_SIDED|95.0|-0.19|1.0|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.00|-0.19|0.177
71013788|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.586|TWO_SIDED|95.0|-0.4|0.7|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.70|-0.40|0.586
71013789|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.448|TWO_SIDED|95.0|-0.92|0.41|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.41|-0.92|0.448
71013790|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.043|TWO_SIDED|95.0|0.02|1.09|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.09|0.02|0.043
71013791|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.688|TWO_SIDED|95.0|-0.59|0.39|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.39|-0.59|0.688
71048215|NCT00876018|141605324|OTHER|||||||0.903||95.0|||||Mann Whitney U test|||||||0.903
71048216|NCT00876018|141605325|OTHER|||||||0.143||95.0|||||Mann Whitney U test|||||||0.143
71048217|NCT00876018|141605325|OTHER|||||||0.678||95.0|||||Mann Whitney U test|||||||0.678
71048218|NCT01189500|141605351|SUPERIORITY_OR_OTHER||ratio of adjusted means|100.69|||||TWO_SIDED|90.0|96.7|104.85|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)||104.85|96.70|
71048219|NCT01189500|141605353|SUPERIORITY_OR_OTHER||ratio of adjusted means|99.44|||||TWO_SIDED|90.0|94.02|105.17|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)||105.17|94.02|
71048220|NCT01189500|141605358|SUPERIORITY_OR_OTHER||ratio of adjusted means|92.04|||||TWO_SIDED|90.0|84.71|100.0|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)||100.00|84.71|
70929186|NCT00661141|141354685|SUPERIORITY||ratio of parameter means|139.63|||||TWO_SIDED|90.0|92.18|211.51|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||211.51|92.18|
71013792|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.032|TWO_SIDED|95.0|-1.25|-0.06|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.06|-1.25|0.032
71013793|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.179|TWO_SIDED|95.0|-0.19|0.99|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4(AM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.99|-0.19|0.179
71013794|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.609|TWO_SIDED|95.0|-0.4|0.69|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.69|-0.40|0.609
71013795|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.435|TWO_SIDED|95.0|-0.92|0.4|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.40|-0.92|0.435
71013796|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.023|TWO_SIDED|95.0|0.1|1.26|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.26|0.10|0.023
71048221|NCT01189500|141605364|SUPERIORITY_OR_OTHER||ratio of adjusted means|112.07|||||TWO_SIDED|90.0|107.44|116.9|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)||116.90|107.44|
71013797|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.987|TWO_SIDED|95.0|-0.54|0.53|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.53|-0.54|0.987
71013798|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.04|TWO_SIDED|95.0|-1.33|-0.03|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.03|-1.33|0.040
71013799|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.319|TWO_SIDED|95.0|-0.31|0.94|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.94|-0.31|0.319
71013800|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.712|TWO_SIDED|95.0|-0.47|0.69|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.69|-0.47|0.712
71013801|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.557|TWO_SIDED|95.0|-0.91|0.49|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.49|-0.91|0.557
71013802|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.015|TWO_SIDED|95.0|0.14|1.28|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.28|0.14|0.015
71013803|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.326|TWO_SIDED|95.0|-0.26|0.79|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.79|-0.26|0.326
71048222|NCT01189500|141605369|SUPERIORITY_OR_OTHER||ratio of adjusted means|105.6|||||TWO_SIDED|90.0|99.74|111.81|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)||111.81|99.74|
71048223|NCT01189500|141605370|SUPERIORITY_OR_OTHER||ratio of adjusted means|108.47|||||TWO_SIDED|90.0|103.51|113.67|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)||113.67|103.51|
71048224|NCT01144364|141605394|SUPERIORITY_OR_OTHER|||||||0.254|||||||Log Rank|||Difference between treatment arms||||0.254
70850480|NCT01305577|141189114|SUPERIORITY_OR_OTHER||LS mean Difference|-1.68|||<|0.001|TWO_SIDED|95.0|-2.5|-0.87|||Mixed Models Repeated Measures|The model includes the fixed effect factors visit and treatment, the visit\*treatment interaction, and the Baseline values as covariate.||||-0.87|-2.50|<0.001
71013804|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.167|TWO_SIDED|95.0|-1.08|0.19|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.19|-1.08|0.167
71013805|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.35|TWO_SIDED|95.0|-0.33|0.93|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.93|-0.33|0.350
71013806|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.235|TWO_SIDED|95.0|-0.23|0.93|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.93|-0.23|0.235
71013807|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.881|TWO_SIDED|95.0|-0.65|0.76|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4(PM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.76|-0.65|0.881
71048225|NCT01144364|141605396|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.105|TWO_SIDED|95.0|0.31|1.12||Overall DFS|Cox proportional-hazards|Adjusted for randomization stratum and the known prognostic factors.||||1.12|0.31|0.105
71048226|NCT01144364|141605397|SUPERIORITY_OR_OTHER|||||||0.751|||||||Log Rank|||||||0.751
71048227|NCT01144364|141605398|SUPERIORITY_OR_OTHER|||||||0.751|||||||Log Rank|||||||0.751
71048228|NCT01144364|141605400|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63||||0.079|TWO_SIDED|95.0|0.38|1.05|||Cox proportional-hazards|||Analysis of overall PFS with Cox proportional-hazards model adjusted for the randomization stratum and the known prognostic factors.||1.05|0.38|0.079
71048229|NCT01144364|141605403|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.103|TWO_SIDED|95.0|0.4|1.09||Univariate analysis|Regression, Cox|Cox model stratified for the stratification groups.||||1.09|0.40|0.103
71048230|NCT01144364|141605403|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.071|TWO_SIDED|95.0|0.37|1.04||Multivariate analysis|Regression, Cox|Adjusted for stratification group, age, sex, Eastern Cooperative Oncology Group Performance Status, FL International prognostic index (FLIPI) score.||||1.04|0.37|0.071
71048231|NCT01144364|141605404|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.084|TWO_SIDED|95.0|0.39|1.06||Univariate analysis|Fine and Gray model|Fine and Gray model stratified for the stratification groups.||||1.06|0.39|0.084
71048232|NCT01144364|141605404|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.052|TWO_SIDED|95.0|0.38|1.0|||Fine and Gray model|Fine and Gray model adjusted for stratification group, age, sex, Eastern Cooperative Oncology Group Performance Status, and FLIPI score||||1.00|0.38|0.052
71048233|NCT01635062|141605405|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.3||||0.69|TWO_SIDED||||||ANOVA|||The hypothesis was that calcitriol therapy would lower plasma renin activity (PRA), when sodium restricted, when compared to placebo.||||0.69
71048234|NCT01635062|141605406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.8||||0.89|TWO_SIDED||||||ANOVA|||The hypothesis was that calcitriol therapy would raise renal plasma flow, when sodium loaded, when compared to placebo.||||0.89
70929187|NCT00661141|141354685|SUPERIORITY||ratio of parameter means|120.76|||||TWO_SIDED|90.0|108.8|134.03|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||134.03|108.80|
70929188|NCT00661141|141354685|SUPERIORITY||ratio of parameter means|143.39|||||TWO_SIDED|90.0|107.72|190.87|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||190.87|107.72|
71048235|NCT01635062|141605407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.0||||0.8|TWO_SIDED||||||ANOVA|||The hypothesis was that calcitriol therapy would lower urine protein, when sodium loaded, when compared to placebo.||||0.80
71048236|NCT01301508|141605412|SUPERIORITY_OR_OTHER|||||||0.008||||||p-value was calculated for the statistical significant difference between greater decrease in vehicle lesion and greater decrease in active lesion for the AN2898 Topical Ointment, 1% + Ointment Vehicle group.|Two-sided sign test|||||||0.008
71048237|NCT01301508|141605412|SUPERIORITY_OR_OTHER|||||||0.017||||||p-value was calculated for the statistical significant difference between greater decrease in vehicle lesion and greater decrease in active lesion for the AN2728 Topical Ointment, 2% + Ointment Vehicle group.|Two-sided sign test|||||||0.017
71048238|NCT03736213|141605454|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.13|TWO_SIDED||||||paired t-test, two-tailed|df = 6|Ultrasound biofeedback treatment condition - visual-acoustic biofeedback treatment condition. Because more accurate productions have lower normalized acoustic values, a negative difference indicates an advantage for US biofeedback.|||||.13
71048239|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|difference in log-transformed GM|-0.01|||||TWO_SIDED|95.0|-0.11|0.09|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4||0.09|-0.11|
71048240|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.27|||||TWO_SIDED|95.0|-0.38|-0.17|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4||-0.17|-0.38|
71048241|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.27|||||TWO_SIDED|95.0|-0.37|-0.16|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4||-0.16|-0.37|
71048242|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.3|||||TWO_SIDED|95.0|0.13|0.46|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B||0.46|0.13|
70929189|NCT00661141|141354685|SUPERIORITY||ratio of parameter means|103.13|||||TWO_SIDED|90.0|84.35|126.1|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||126.10|84.35|
70929190|NCT00661141|141354685|SUPERIORITY||ratio of parameter means|123.17|||||TWO_SIDED|90.0|108.61|139.67|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included.||139.67|108.61|
71048243|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.13|||||TWO_SIDED|95.0|-0.04|0.29|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B||0.29|-0.04|
71048244|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.17|||||TWO_SIDED|95.0|-0.33|-0.01|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B||-0.01|-0.33|
71104228|NCT04983979|141715498|OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||0.00|0.00|
71104229|NCT04983979|141715499|OTHER||Risk Difference (RD)|0.25|||||TWO_SIDED|95.0|-0.174|0.674||||||Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||0.674|-0.174|
71104230|NCT04983979|141715500|OTHER||Mean Difference (Final Values)|-4.0|||||TWO_SIDED|95.0|-19.5|11.4||||||Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||11.4|-19.5|
70929191|NCT00661141|141354685|SUPERIORITY||ratio of parameter means|137.17|||||TWO_SIDED|90.0|123.3|152.59|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analyses for Cohort 3 where all available data were included.||152.59|123.30|
70929192|NCT00661141|141354687|SUPERIORITY||ratio of parameter means|121.81|||||TWO_SIDED|90.0|108.42|136.84|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||136.84|108.42|
71013808|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.036|TWO_SIDED|95.0|0.04|1.16|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.16|0.04|0.036
71013809|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.656|TWO_SIDED|95.0|-0.4|0.63|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.63|-0.40|0.656
71013810|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.13|TWO_SIDED|95.0|-1.11|0.14|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.14|-1.11|0.130
70929193|NCT00661141|141354687|SUPERIORITY||ratio of parameter means|123.7|||||TWO_SIDED|90.0|93.55|163.56|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||163.56|93.55|
70929194|NCT00661141|141354687|SUPERIORITY||ratio of parameter means|150.33|||||TWO_SIDED|90.0|93.14|242.63|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||242.63|93.14|
71013811|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.304|TWO_SIDED|95.0|-0.3|0.95|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.95|-0.30|0.304
71013812|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.491|TWO_SIDED|95.0|-0.37|0.78|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.78|-0.37|0.491
71048245|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.06|||||TWO_SIDED|95.0|-0.16|0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V||0.04|-0.16|
71048246|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.06|||||TWO_SIDED|95.0|-0.16|0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V||0.04|-0.16|
71048247|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.0|||||TWO_SIDED|95.0|-0.1|0.1|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V||0.10|-0.10|
71048248|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.03|||||TWO_SIDED|95.0|-0.15|0.09|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14||0.09|-0.15|
71048249|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.04|||||TWO_SIDED|95.0|-0.16|0.08|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14||0.08|-0.16|
71048250|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.01|||||TWO_SIDED|95.0|-0.13|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14||0.11|-0.13|
71048251|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.03|||||TWO_SIDED|95.0|-0.13|0.07|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C||0.07|-0.13|
70929195|NCT00661141|141354687|SUPERIORITY||ratio of parameter means|122.83|||||TWO_SIDED|90.0|82.45|183.0|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analysis for Cohort 3 where all available data were included.||183.00|82.45|
70929196|NCT00661141|141354693|SUPERIORITY||ratio of parameter means|69.13|||||TWO_SIDED|90.0|48.88|97.78|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||97.78|48.88|
70929197|NCT00661141|141354693|SUPERIORITY||ratio of parameter means|124.46|||||TWO_SIDED|90.0|88.77|174.5|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||174.50|88.77|
70929198|NCT00661141|141354693|SUPERIORITY||ratio of parameter means|105.31|||||TWO_SIDED|90.0|89.24|124.27|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||124.27|89.24|
70929199|NCT00661141|141354693|SUPERIORITY||ratio of parameter means|88.6|||||TWO_SIDED|90.0|56.66|138.54|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||138.54|56.66|
70929200|NCT00661141|141354693|SUPERIORITY||ratio of parameter means|70.77|||||TWO_SIDED|90.0|34.16|146.59|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included.||146.59|34.16|
70929201|NCT00661141|141354693|SUPERIORITY||ratio of parameter means|86.04|||||TWO_SIDED|90.0|55.78|132.73|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analyses for Cohort 3 where all available data were included.||132.73|55.78|
71048252|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.13|||||TWO_SIDED|95.0|-0.23|-0.03|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C||-0.03|-0.23|
71048253|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.1|||||TWO_SIDED|95.0|-0.2|0.0|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C||-0.00|-0.20|
70929202|NCT00661141|141354696|SUPERIORITY||ratio of parameter means|90.2|||||TWO_SIDED|90.0|69.54|117.0|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||117.00|69.54|
70929203|NCT00661141|141354696|SUPERIORITY||ratio of parameter means|112.28|||||TWO_SIDED|90.0|103.72|121.54|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||121.54|103.72|
70929204|NCT00661141|141354696|SUPERIORITY||ratio of parameter means|106.08|||||TWO_SIDED|90.0|96.81|116.24|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||116.24|96.81|
70929205|NCT00661141|141354696|SUPERIORITY||ratio of parameter means|104.12|||||TWO_SIDED|90.0|83.5|129.84|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||129.84|83.50|
70929206|NCT00661141|141354696|SUPERIORITY||ratio of parameter means|100.41|||||TWO_SIDED|90.0|77.86|129.49|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included.||129.49|77.86|
70929207|NCT00661141|141354696|SUPERIORITY||ratio of parameter means|94.7|||||TWO_SIDED|90.0|82.7|108.42|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analyses for Cohort 3 where all available data were included.||108.42|82.70|
70929208|NCT00661141|141354698|SUPERIORITY||ratio of parameter means|94.15|||||TWO_SIDED|90.0|78.01|1113.63|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||1113.63|78.01|
70929209|NCT00661141|141354698|SUPERIORITY||ratio of parameter means|107.05|||||TWO_SIDED|90.0|87.42|131.1|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included.||131.10|87.42|
71048254|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.11|||||TWO_SIDED|95.0|-0.22|-0.01|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F||-0.01|-0.22|
71048255|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.34|||||TWO_SIDED|95.0|-0.44|-0.23|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F||-0.23|-0.44|
71048256|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.22|||||TWO_SIDED|95.0|-0.33|-0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F||-0.11|-0.33|
71048257|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.03|||||TWO_SIDED|95.0|-0.16|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F||0.11|-0.16|
71048258|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.18|||||TWO_SIDED|95.0|0.04|0.31|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F||0.31|0.04|
71104231|NCT05293314|141715523|OTHER|Evaluate the ability of the breath test model to distinguish bronchiectasis from healthy individuals by measuring the area under the receiver operating characteristic (ROC) curves. The maximum value in the area below the receiver is 1. The closer the value is to 1, the higher the prediction accuracy of the model.|receiver operating characteristic|0.964|||<|0.05|TWO_SIDED|95.0|0.932|0.996|||Wilcoxon (Mann-Whitney)|||Evaluate the ability of the breath test model to distinguish bronchiectasis from healthy individuals by measuring the area under the receiver operating characteristic (ROC) curves. The maximum value in the area below the receiver is 1. The closer the value is to 1, the higher the prediction accuracy of the model.||0.996|0.932|<0.05
71104232|NCT05293314|141715523|OTHER|Evaluate the ability of the breath test model to distinguish bronchiectasis from healthy individuals by measuring the area under the receiver operating characteristic (ROC) curves. The maximum value in the area below the receiver is 1. The closer the value is to 1, the higher the prediction accuracy of the model.|receiver operating characteristic|0.932|||<|0.05|TWO_SIDED|95.0|0.879|0.982|||Wilcoxon (Mann-Whitney)|||Evaluate the ability of the breath test model to distinguish bronchiectasis from healthy individuals by measuring the area under the receiver operating characteristic (ROC) curves. The maximum value in the area below the receiver is 1. The closer the value is to 1, the higher the prediction accuracy of the model.||0.982|0.879|<0.05
71117594|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.05||||0.311|TWO_SIDED|95.0|-4.6|14.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.71|-4.60|0.311
70929210|NCT00661141|141354698|SUPERIORITY||ratio of parameter means|97.9|||||TWO_SIDED|90.0|84.84|112.97|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analyses for Cohort 3 where all available data were included.||112.97|84.84|
70929211|NCT05828017|141354702|SUPERIORITY||Mean Difference (Final Values)|1.107|||<|0.001|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts per participant between the standard curve, variation #1, and no preference counts.||||<0.001
71048259|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.2|||||TWO_SIDED|95.0|0.07|0.34|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F||0.34|0.07|
71048260|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.11|||||TWO_SIDED|95.0|-0.23|0.01|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1||0.01|-0.23|
71117595|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
70929212|NCT05828017|141354702|SUPERIORITY||Mean Difference (Final Values)|0.544||||0.015|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference between Variation #1 and the standard curve in terms of mean preference counts per participant.||||0.015
71048261|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.16|||||TWO_SIDED|95.0|-0.28|-0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1||-0.04|-0.28|
71048262|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.05|||||TWO_SIDED|95.0|-0.17|0.06|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1||0.06|-0.17|
71048263|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.09|||||TWO_SIDED|95.0|-0.19|0.02|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3||0.02|-0.19|
71048264|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.18|||||TWO_SIDED|95.0|-0.28|-0.07|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3||-0.07|-0.28|
71048265|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.09|||||TWO_SIDED|95.0|-0.19|0.02|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3||0.02|-0.19|
71048266|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.25|||||TWO_SIDED|95.0|0.13|0.37|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5||0.37|0.13|
70929213|NCT05828017|141354703|SUPERIORITY||Mean Difference (Final Values)|1.039|||<|0.001|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts per participant between the standard curve, variation #1, and no preference counts.||||<0.001
70929214|NCT05828017|141354703|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.03569|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts between the standard curve and variation #1.||||0.03569
71104233|NCT05293314|141715524|OTHER|Sensitivity=number of true positives/(number of true positives+number of false negatives) \* 100% Sensitivity is the rate of correctly judging patients.We calculated the sensitivity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the sensitivity is 100%. The higher the percentage is , the more sensitive of the model.|Sensitivity|86.2|||||TWO_SIDED|95.0|77.1|95.2||||||Sensitivity=number of true positives/(number of true positives+number of false negatives) \* 100% Sensitivity is the rate of correctly judging patients.We calculated the sensitivity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the sensitivity is 100%. The higher the percentage is , the more sensitive of the model.||95.2|77.1|
71104234|NCT05293314|141715524|OTHER|Sensitivity=number of true positives/(number of true positives+number of false negatives) \* 100% Sensitivity is the rate of correctly judging patients.We calculated the sensitivity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the sensitivity is 100%. The higher the percentage is , the more sensitive of the model.|Sensitivity|86.2|||||TWO_SIDED|95.0|77.1|95.2||||||Sensitivity=number of true positives/(number of true positives+number of false negatives) \* 100% Sensitivity is the rate of correctly judging patients.We calculated the sensitivity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the sensitivity is 100%. The higher the percentage is , the more sensitive of the model.||95.2|77.1|
71104235|NCT05293314|141715525|OTHER|Specificity=number of true negative cases/(number of true negative cases+number of false positive cases) \* 100% The specificity is the rate of correctly judging non patients.We calculated the specificity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the specificity is 100%. The higher the percentage is , the more specificity of the model.|Specificity|92.5|||||TWO_SIDED|95.0|86.2|98.8||||||Specificity=number of true negative cases/(number of true negative cases+number of false positive cases) \* 100% The specificity is the rate of correctly judging non patients.We calculated the specificity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the specificity is 100%. The higher the percentage is , the more specificity of the model.||98.8|86.2|
70929215|NCT05828017|141354704|SUPERIORITY||Mean Difference (Final Values)|0.365||||0.069|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts per participant between the standard curve, variation #1, and no preference counts.||||0.069
70929216|NCT05828017|141354704|SUPERIORITY||Mean Difference (Final Values)|0.087||||0.6976|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts between the standard curve and variation #1.||||0.6976
71048267|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.0|||||TWO_SIDED|95.0|-0.12|0.12|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5||0.12|-0.12|
70929217|NCT05828017|141354705|SUPERIORITY||Mean Difference (Final Values)|0.876|||<|0.001|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts per participant between the standard curve, variation #1, and no preference counts.||||<0.001
70929218|NCT05828017|141354705|SUPERIORITY||Mean Difference (Final Values)|0.728||||0.0013|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts between the standard curve and variation #1.||||0.0013
70929219|NCT05828017|141354706|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.522|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.522
70929220|NCT05828017|141354706|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.27|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts between the standard curve and variation #1.||||0.27
70929221|NCT05828017|141354707|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.28|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.28
70929222|NCT05828017|141354707|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.11|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||0.11
70929223|NCT05828017|141354708|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.52|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.52
71048268|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.25|||||TWO_SIDED|95.0|-0.37|-0.13|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5||-0.13|-0.37|
71048269|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.14|||||TWO_SIDED|95.0|0.02|0.25|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A||0.25|0.02|
71048270|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.12|||||TWO_SIDED|95.0|0.01|0.24|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A||0.24|0.01|
70929224|NCT05828017|141354708|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.26|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||0.26
70929225|NCT05828017|141354709|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.16|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.16
70929226|NCT05828017|141354709|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.37|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||0.37
70929227|NCT05828017|141354710|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.08|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.08
70929228|NCT05828017|141354710|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.31|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||0.31
70929229|NCT05828017|141354711|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.21|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.21
70929230|NCT05828017|141354711|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.085|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||0.085
70929231|NCT05828017|141354712|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.86|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.86
70929232|NCT05828017|141354712|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||1
70929233|NCT05828017|141354713|SUPERIORITY||Mean Difference (Final Values)|0.607||||0.009|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.009
70929234|NCT05828017|141354713|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.61|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||0.61
70929235|NCT05828017|141354714|SUPERIORITY||Mean Difference (Final Values)|0.28|||<|0.001|TWO_SIDED|95.0|0.11|1.0|||ANOVA|||This is to see if there is a difference in mean SRT50 scores between the standard curve, variation #1, and no preference counts.||1.00|0.11|<0.001
70929236|NCT05828017|141354714|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.357|TWO_SIDED|95.0|0.0|1.0|||ANOVA|||This is to see if there is a difference in SRT 50 scores between the standard curve and variation #1.||1|0|0.357
70929237|NCT05828017|141354715|SUPERIORITY||Total Count - Cramer's V|0.7|||<|0.01|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in most preferred program counts between variations #2, #3, and #4||||<0.01
71013813|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.726|TWO_SIDED|95.0|-0.82|0.57|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.57|-0.82|0.726
71013814|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.029|TWO_SIDED|95.0|0.07|1.23|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.23|0.07|0.029
71013815|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.585|TWO_SIDED|95.0|-0.39|0.68|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.68|-0.39|0.585
71013816|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.131|TWO_SIDED|95.0|-1.15|0.15|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.15|-1.15|0.131
71013817|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.215|TWO_SIDED|95.0|-0.24|1.04|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.04|-0.24|0.215
71013818|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.244|TWO_SIDED|95.0|-0.24|0.94|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.94|-0.24|0.244
71013819|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.885|TWO_SIDED|95.0|-0.76|0.66|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.66|-0.76|0.885
71013820|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.067|TWO_SIDED|95.0|-0.04|1.13|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.13|-0.04|0.067
71048271|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.01|||||TWO_SIDED|95.0|-0.13|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A||0.11|-0.13|
71048272|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.01|||||TWO_SIDED|95.0|-0.09|0.1|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F||0.10|-0.09|
71013821|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.5|TWO_SIDED|95.0|-0.35|0.73|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.73|-0.35|0.500
71013822|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.276|TWO_SIDED|95.0|-1.02|0.29|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.29|-1.02|0.276
71013823|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.413|TWO_SIDED|95.0|-0.38|0.92|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.92|-0.38|0.413
70929238|NCT05828017|141354715|SUPERIORITY||Total Count - Cramer's V|0.01||||0.94|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in most preferred program counts between variations #2 and #3.||||0.94
70929239|NCT05828017|141354715|SUPERIORITY||Total Count - Cramer's V|0.014||||0.94|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in most preferred program counts between variations #2 and #4||||0.94
70929240|NCT05828017|141354715|SUPERIORITY||Total Count - Cramer's V|0.45||||0.017|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in somewhat preferred (i.e. rated in the middle) program counts between variations #2, #3, and #4||||0.017
71013824|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.448|TWO_SIDED|95.0|-0.37|0.83|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.83|-0.37|0.448
71013825|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.917|TWO_SIDED|95.0|-0.76|0.69|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.69|-0.76|0.917
71013826|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.132|TWO_SIDED|95.0|-0.13|1.03|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.03|-0.13|0.132
71013827|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.505|TWO_SIDED|95.0|-0.35|0.72|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.72|-0.35|0.505
71013828|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.422|TWO_SIDED|95.0|-0.92|0.38|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.38|-0.92|0.422
71048273|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.05|||||TWO_SIDED|95.0|-0.14|0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F||0.04|-0.14|
71048274|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.06|||||TWO_SIDED|95.0|-0.15|0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F||0.04|-0.15|
71048275|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.08|||||TWO_SIDED|95.0|-0.19|0.03|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A||0.03|-0.19|
70929241|NCT05828017|141354715|SUPERIORITY||Total Count - Cramer's V|0.51||||0.02|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in somewhat preferred (i.e. rated in the middle) program counts between variations #2 and #3.||||0.02
70929242|NCT05828017|141354715|SUPERIORITY||Total Count - Cramer's V|0.61||||0.006|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in somewhat preferred (i.e. rated in the middle) program counts between variations #2 and #4||||0.006
71048276|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.02|||||TWO_SIDED|95.0|-0.12|0.09|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A||0.09|-0.12|
71104236|NCT05293314|141715525|OTHER|Specificity=number of true negative cases/(number of true negative cases+number of false positive cases) \* 100% The specificity is the rate of correctly judging non patients.We calculated the specificity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the specificity is 100%. The higher the percentage is , the more specificity of the model.|Specificity|73.9|||||TWO_SIDED|95.0|56.0|91.9||||||Specificity=number of true negative cases/(number of true negative cases+number of false positive cases) \* 100% The specificity is the rate of correctly judging non patients.We calculated the specificity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the specificity is 100%. The higher the percentage is , the more specificity of the model.||91.9|56|
70929243|NCT05828017|141354715|SUPERIORITY||Total Count - Cramer's V|0.6|||<|0.0001|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in the least preferred program counts between variations #2, #3, and #4||||<.0001
71013829|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.747|TWO_SIDED|95.0|-0.54|0.76|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.76|-0.54|0.747
70929244|NCT05828017|141354715|SUPERIORITY||Total Count - Cramer's V|0.38||||0.08|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in the least preferred program counts between variations #2 and #3||||0.08
70929245|NCT05828017|141354715|SUPERIORITY||Total Count - Cramer's V|0.5|||<|0.001|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in the least preferred program counts between variations #2 and #4||||<0.001
71013830|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.386|TWO_SIDED|95.0|-0.34|0.87|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.87|-0.34|0.386
71013831|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.668|TWO_SIDED|95.0|-0.57|0.89|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.89|-0.57|0.668
71048277|NCT00444457|141605455|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.06|||||TWO_SIDED|95.0|-0.05|0.17|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A||0.17|-0.05|
71048278|NCT00444457|141605456|NON_INFERIORITY_OR_EQUIVALENCE|For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.|Difference|-0.1|||||TWO_SIDED|95.0|-3.3|3.0|||||Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|Tetanus toxoid: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.||3.0|-3.3|
71048279|NCT00444457|141605457|NON_INFERIORITY_OR_EQUIVALENCE|For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.|Difference|0.0|||||TWO_SIDED|95.0|-2.1|2.0|||||Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|Poliovirus type 1: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.||2.0|-2.1|
71048280|NCT00444457|141605457|NON_INFERIORITY_OR_EQUIVALENCE|For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.|Difference|-0.6|||||TWO_SIDED|95.0|-3.4|2.0|||||Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|Poliovirus type 2: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.||2.0|-3.4|
71048281|NCT00444457|141605457|NON_INFERIORITY_OR_EQUIVALENCE|For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.|Difference|0.5|||||TWO_SIDED|95.0|-1.5|3.0|||||Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|Poliovirus type 3: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.||3.0|-1.5|
71048282|NCT00444457|141605458|NON_INFERIORITY_OR_EQUIVALENCE|For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.|Difference|0.0|||||TWO_SIDED|95.0|-2.4|2.2|||||Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|Hepatitis B: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.||2.2|-2.4|
71048283|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|2.0|||||TWO_SIDED|95.0|-0.51|4.75||||||Common serotypes - serotype 4||4.75|-0.51|
71048284|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.9|||||TWO_SIDED|95.0|-3.09|1.1||||||Common serotypes - serotype 4||1.10|-3.09|
71048285|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-2.9|||||TWO_SIDED|95.0|-5.58|-0.58||||||Common serotypes - serotype 4||-0.58|-5.58|
71048286|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|5.3|||||TWO_SIDED|95.0|1.55|9.19||||||Common serotypes - serotype 6B||9.19|1.55|
71048287|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.4|||||TWO_SIDED|95.0|-2.77|3.66||||||Common serotypes - serotype 6B||3.66|-2.77|
71048288|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-4.9|||||TWO_SIDED|95.0|-8.82|-1.1||||||Common serotypes - serotype 6B||-1.10|-8.82|
71048289|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.2|||||TWO_SIDED|95.0|-3.13|2.83||||||Common serotypes - serotype 9V||2.83|-3.13|
71048290|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.1|||||TWO_SIDED|95.0|-3.97|1.73||||||Common serotypes - serotype 9V||1.73|-3.97|
71048291|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.9|||||TWO_SIDED|95.0|-3.81|1.88||||||Common serotypes - serotype 9V||1.88|-3.81|
71104237|NCT00835367|141715526|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|101.84||||||90.0|98.22|105.59|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.59|98.22|
71104238|NCT00835367|141715527|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Slope|102.53||||||90.0|99.71|105.44|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.44|99.71|
71013832|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.099|TWO_SIDED|95.0|-0.09|1.08|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.08|-0.09|0.099
71013833|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.365|TWO_SIDED|95.0|-0.29|0.79|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.79|-0.29|0.365
71013834|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.463|TWO_SIDED|95.0|-0.9|0.41|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.41|-0.90|0.463
71013835|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.845|TWO_SIDED|95.0|-0.6|0.73|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.73|-0.60|0.845
71013836|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.199|TWO_SIDED|95.0|-0.21|1.02|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.02|-0.21|0.199
71013837|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.375|TWO_SIDED|95.0|-0.41|1.08|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||1.08|-0.41|0.375
71104239|NCT00835367|141715528|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|102.49||||||90.0|99.75|105.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.30|99.75|
71013838|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.028|TWO_SIDED|95.0|0.07|1.27|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.27|0.07|0.028
71013839|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.188|TWO_SIDED|95.0|-0.18|0.92|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.92|-0.18|0.188
71013840|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.375|TWO_SIDED|95.0|-0.97|0.37|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.37|-0.97|0.375
71013841|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.552|TWO_SIDED|95.0|-0.47|0.89|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.89|-0.47|0.552
71048292|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.3|||||TWO_SIDED|95.0|-1.27|1.95||||||Common serotypes - serotype 14||1.95|-1.27|
71048293|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|1.1|||||TWO_SIDED|95.0|-0.6|3.01||||||Common serotypes - serotype 14||3.01|-0.60|
71048294|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.8|||||TWO_SIDED|95.0|-1.04|2.76||||||Common serotypes - serotype 14||2.76|-1.04|
71013842|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.126|TWO_SIDED|95.0|-0.14|1.12|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.12|-0.14|0.126
71013843|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.46|TWO_SIDED|95.0|-0.47|1.05|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||1.05|-0.47|0.460
71013844|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.095|TWO_SIDED|95.0|-0.09|1.09|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.09|-0.09|0.095
71104240|NCT00835367|141715529|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|91.79||||||90.0|84.83|99.32|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||99.32|84.83|
71048295|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|2.1|||||TWO_SIDED|95.0|-0.38|4.74||||||Common serotypes - serotype 18C||4.74|-0.38|
70929246|NCT05012163|141354716|SUPERIORITY|||||||0.506||||||Pairwise comparisons between patients offered scratch-off tickets for vaccination and those in other arms (Analyses 1, 2 and 3) were analyzed in the same regression.|Regression, Linear|||Null hypothesis: There is no difference in vaccination rates between patients sent messages offering a scratch-off lottery ticket and patients sent messages offering $1 cash in exchange for vaccination; Alternative hypothesis: the vaccination rate is higher in patients sent messages offering scratch-off tickets compared to those sent messages offering $1 cash.||||.506
71104241|NCT00835367|141715530|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|95.85||||||90.0|92.54|99.27|||||Metabolite presented for informational purposes only.|||99.27|92.54|
71104242|NCT00835367|141715531|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|100.28||||||90.0|98.3|102.3|||||Metabolite presented for informational purposes only|||102.30|98.30|
71104243|NCT00835367|141715532|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|102.74||||||90.0|100.35|105.19|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.19|100.35|
71104244|NCT00835367|141715533|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|102.72||||||90.0|100.3|105.2|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.20|100.30|
71104245|NCT00835367|141715534|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|100.28||||||90.0|98.25|102.35|||||Metabolite presented for informational purposes only.|||102.35|98.25|
71104246|NCT00791648|141715537|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75|||||||Pearson x2|||||||.75
71104247|NCT00791648|141715538|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||||||.56
71104248|NCT00791648|141715539|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||||||.71
71104249|NCT00791648|141715540|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||.11
71048296|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.2|||||TWO_SIDED|95.0|-2.33|1.99||||||Common serotypes - serotype 18C||1.99|-2.33|
71048297|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-2.2|||||TWO_SIDED|95.0|-4.89|0.23||||||Common serotypes - serotype 18C||0.23|-4.89|
71104250|NCT00791648|141715541|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||.06
71104251|NCT00791648|141715542|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||.39
71104252|NCT02947984|141715562|OTHER|||||||0.234|||||||Log Rank|||Null hypothesis: Progression free survival is not significantly different by dose level in the overall cohort.||||0.234
71104253|NCT02947984|141715562|OTHER|||||||0.82|||||||Log Rank|||Null hypothesis: Progression free survival is not significantly different by dose level in the subgroup receiving treatment due to a sub-total resection||||.820
71104254|NCT02947984|141715562|OTHER|||||||0.061|||||||Log Rank|||Null hypothesis: Progression free survival is not significantly different by dose level in the sub-group receiving treatment due to recurrent disease||||.061
71104255|NCT03440385|141715589|SUPERIORITY||Odds Ratio (OR)|0.96||||0.8125|TWO_SIDED|95.0|0.66|1.39|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.39|0.66|0.8125
71104256|NCT03440385|141715590|SUPERIORITY||Odds Ratio (OR)|1.13||||0.54|TWO_SIDED|95.0|0.77|1.66|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.66|0.77|0.5400
71104257|NCT03440385|141715591|SUPERIORITY||Odds Ratio (OR)|1.28||||0.2411|TWO_SIDED|95.0|0.85|1.95|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.95|0.85|0.2411
71104258|NCT03440385|141715592|SUPERIORITY||Odds Ratio (OR)|0.94||||0.7469|TWO_SIDED|95.0|0.67|1.34|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.34|0.67|0.7469
71104259|NCT03440385|141715593|SUPERIORITY||Odds Ratio (OR)|1.22||||0.4255|TWO_SIDED|95.0|0.75|1.97|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.97|0.75|0.4255
71104260|NCT03440385|141715594|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9313|TWO_SIDED|95.0|0.6|1.76|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.76|0.60|0.9313
71104261|NCT03440385|141715595|SUPERIORITY||Odds Ratio (OR)|1.27||||0.4339|TWO_SIDED|95.0|0.7|2.31|||Cochran-Mantel-Haenszel|Odds ratio and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||2.31|0.70|0.4339
71104262|NCT03440385|141715596|SUPERIORITY||Odds Ratio (OR)|1.3||||0.333|TWO_SIDED|95.0|0.77|2.2|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||2.20|0.77|0.3330
71104263|NCT03440385|141715597|SUPERIORITY||Odds Ratio (OR)|1.04||||0.82|TWO_SIDED|95.0|0.74|1.47|||Cochran-Mantel-Haenszel|Odds ratio and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.47|0.74|0.8200
70929247|NCT05012163|141354716|SUPERIORITY|||||||0.378||||||Comments: Pairwise comparisons between patients offered scratch-off tickets for vaccination and those in other arms (Analyses 1, 2 and 3) were analyzed in the same regression.|Regression, Linear|||Null hypothesis: There is no difference in vaccination rates between patients sent messages offering a scratch-off lottery ticket in exchange for vaccination and those sent active control messages; Alternative hypothesis: the vaccination rate is higher in patients sent messages offering scratch-off tickets compared to those sent active control messages.||||0.378
71013845|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.146|TWO_SIDED|95.0|-0.14|0.94|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.94|-0.14|0.146
71013846|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.769|TWO_SIDED|95.0|-0.75|0.56|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.56|-0.75|0.769
71013847|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.405|TWO_SIDED|95.0|-0.39|0.96|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.96|-0.39|0.405
71013848|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.073|TWO_SIDED|95.0|-0.05|1.2|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.20|-0.05|0.073
71013849|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.458|TWO_SIDED|95.0|-0.47|1.04|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||1.04|-0.47|0.458
71013850|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8||||0.009|TWO_SIDED|95.0|0.2|1.39|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.39|0.20|0.009
71013851|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.209|TWO_SIDED|95.0|-0.2|0.9|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.90|-0.20|0.209
71013852|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.193|TWO_SIDED|95.0|-1.11|0.22|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.22|-1.11|0.193
71048298|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.3|||||TWO_SIDED|95.0|-1.93|2.6||||||Common serotypes - serotype 19F||2.60|-1.93|
71013853|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.149|TWO_SIDED|95.0|-0.18|1.18|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.18|-0.18|0.149
71013854|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.186|TWO_SIDED|95.0|-0.21|1.06|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.06|-0.21|0.186
71013855|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.845|TWO_SIDED|95.0|-0.84|0.69|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.69|-0.84|0.845
71048299|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.5|||||TWO_SIDED|95.0|-3.46|0.28||||||Common serotypes - serotype 19F||0.28|-3.46|
71013856|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.067|TWO_SIDED|95.0|-0.04|1.14|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.14|-0.04|0.067
71013857|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.242|TWO_SIDED|95.0|-0.22|0.87|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.87|-0.22|0.242
71013858|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.498|TWO_SIDED|95.0|-0.88|0.43|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.43|-0.88|0.498
71048300|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.8|||||TWO_SIDED|95.0|-3.87|0.02||||||Common serotypes - serotype 19F||0.02|-3.87|
71048301|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|3.2|||||TWO_SIDED|95.0|-1.03|7.46||||||Common serotypes - serotype 23F||7.46|-1.03|
71048302|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|4.0|||||TWO_SIDED|95.0|-0.27|8.39||||||Common serotypes - serotype 23F||8.39|-0.27|
71048303|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.8|||||TWO_SIDED|95.0|-3.75|5.46||||||Common serotypes - serotype 23F||5.46|-3.75|
71048304|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.8|||||TWO_SIDED|95.0|-1.48|3.18||||||Additional serotypes - serotype 1||3.18|-1.48|
71048305|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.7|||||TWO_SIDED|95.0|-2.78|1.34||||||Additional serotypes - serotype 1||1.34|-2.78|
71048306|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.5|||||TWO_SIDED|95.0|-3.77|0.67||||||Additional serotypes - serotype 1||0.67|-3.77|
71048307|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-3.9|||||TWO_SIDED|95.0|-10.27|2.45||||||Additional serotypes - serotype 3||2.45|-10.27|
71104264|NCT03440385|141715598|SUPERIORITY||Odds Ratio (OR)|1.06||||0.7776|TWO_SIDED|95.0|0.71|1.59|||Cochran-Mantel-Haenszel|Odds ratio and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.59|0.71|0.7776
71104265|NCT03440385|141715599|SUPERIORITY||Odds Ratio (OR)|1.39||||0.1187|TWO_SIDED|95.0|0.92|2.11|||Cochran-Mantel-Haenszel|Odds ratio and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no)||||2.11|0.92|0.1187
71104266|NCT03440385|141715600|SUPERIORITY||Odds Ratio (OR)|1.28||||0.403|TWO_SIDED|95.0|0.72|2.26|||Cochran-Mantel-Haenszel|Odds ratio and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no)||||2.26|0.72|0.4030
71013859|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.33|TWO_SIDED|95.0|-0.34|1.02|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.02|-0.34|0.330
71013860|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.124|TWO_SIDED|95.0|-0.14|1.13|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.13|-0.14|0.124
71013861|NCT01945034|141534109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.687|TWO_SIDED|95.0|-0.61|0.92|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.92|-0.61|0.687
71013862|NCT01945034|141534110|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0||||0.166|TWO_SIDED|95.0|-0.85|4.95|||ANOVA|p-value \<=0.05 for treatment effects||At Rest over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||4.95|-0.85|0.166
71013863|NCT01945034|141534110|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7||||0.199|TWO_SIDED|95.0|-4.42|0.93|||ANOVA|p-value \<=0.05 for treatment effects||At Rest over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.93|-4.42|0.199
71013864|NCT01945034|141534110|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.8||||0.022|TWO_SIDED|95.0|-7.04|-0.56|||ANOVA|p-value \<=0.05 for treatment effects||At Rest over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.56|-7.04|0.022
71013865|NCT01945034|141534110|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.26|TWO_SIDED|95.0|-1.3|4.79|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||4.79|-1.30|0.260
71013866|NCT01945034|141534110|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.729|TWO_SIDED|95.0|-3.31|2.32|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||2.32|-3.31|0.729
70929248|NCT05012163|141354716|SUPERIORITY||||||<|0.001||||||Pairwise comparisons between patients offered scratch-off tickets for vaccination and those in other arms (Analyses 1, 2 and 3) were analyzed in the same regression.|Regression, Linear|||Null hypothesis: There is no difference in vaccination rates between patients sent messages offering a scratch-off lottery ticket in exchange for vaccination and those sent no study messages; Alternative hypothesis: the vaccination rate is higher in patients sent messages offering scratch-off tickets compared to those who were not sent messages.||||<.001
70929249|NCT05012163|141354716|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||Null hypothesis: There is no difference in vaccination rates between patients sent active control messages and those sent no study messages; Alternative hypothesis: the vaccination rate is higher in patients sent active control messages compared to those who were not sent messages.||||<.001
70929250|NCT05012163|141354716|SUPERIORITY|Pairwise comparisons between patients offered cash for vaccination and those in active or passive control (Analyses 5 and 6) were analyzed in the same regression.||||||0.121|||||||Regression, Linear|||Null hypothesis: There is no difference in vaccination rates between patients sent messages offering $1 cash in exchange for vaccination and those sent active control messages; Alternative hypothesis: the vaccination rate is higher in patients sent messages offering $1 cash compared to those sent active control messages.||||.121
70929251|NCT05012163|141354716|SUPERIORITY|||||||0.002||||||Pairwise comparisons between patients offered cash for vaccination and those in active or passive control (Analyses 5 and 6) were analyzed in the same regression.|Regression, Linear|||Null hypothesis: There is no difference in vaccination rates between patients sent messages offering $1 cash in exchange for vaccination and those sent no study messages; Alternative hypothesis: the vaccination rate is higher in patients sent messages offering $1 cash compared to those who were not sent messages.||||.002
70929252|NCT05062330|141354725|SUPERIORITY||Odds Ratio (OR)|2.63|||<|0.0001|TWO_SIDED|95.0|1.67|4.13|||Generalized estimating equation|||||4.13|1.67|<0.0001
70929253|NCT02567409|141354734|SUPERIORITY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.69|1.98|||||Hazard ratio relative to arm B.|||1.98|0.69|
70929254|NCT02567409|141354735|SUPERIORITY||Hazard Ratio (HR)|1.33|||||TWO_SIDED|95.0|0.71|2.48|||||Hazard ratio relative to arm B.|||2.48|0.71|
70929255|NCT02567409|141354736|SUPERIORITY|||||||0.51|||||||Fisher Exact|||||||0.51
70929256|NCT03308877|141354805|OTHER|||||||0.07||||||Covariates include education \& percent days abstinent at baseline.|Regression, Linear|||Hypothesis 1: Affective psychopathy scores will moderate response to a BMI such that individuals with lower scores will benefit relative to controls, but individuals with higher psychopathy scores will not benefit from the intervention in terms of percent days abstinent.||||.07
71048308|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-10.7|||||TWO_SIDED|95.0|-16.8|-4.57||||||Additional serotypes - serotype 3||-4.57|-16.80|
70929257|NCT03308877|141354805|OTHER|||||||0.02|||||||Regression, Linear|||Sensitivity analysis: proximal follow-up (3 months following BMI or SC)||||.02
70929258|NCT03308877|141354805|OTHER||B|0.063|||<|0.01|TWO_SIDED|95.0|0.007|0.156|||Regression, Linear|bias corrected bootstrap||Increased readiness to change will be associated with decreased substance use.||.156|.007|<.01
70929259|NCT03308877|141354806|OTHER|||||||0.74|||||||Regression, Linear|||||||.74
70929260|NCT03308877|141354807|OTHER|||||||0.88|||||||Regression, Logistic|||||||.88
70929261|NCT04359654|141354828|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
70929262|NCT04359654|141354829|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
70929263|NCT04359654|141354831|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||||||0.004
70929264|NCT04359654|141354832|SUPERIORITY|||||||0.021|||||||Mixed Models Analysis|||The reported LS means are antilogs of the LS means estimated on the log scale.||||0.021
70929265|NCT03625115|141354886|EQUIVALENCE|A two-tailed t-test was done to compare the mean Bayley cognitive scores between the groups.||||||0.3|||||||t-test, 2 sided|||||||0.30
70929266|NCT03625115|141354887|SUPERIORITY||Pearson chi square (1)|8.51||||0.004|TWO_SIDED||||||Chi-squared|||Chi-square test of independence to determine if there was a significant difference between intervention arms for those who completed a multidisciplinary evaluation (referral completed).||||.004
70929267|NCT03625115|141354888|SUPERIORITY||Pearson chi square (1)|0.05||||0.82|TWO_SIDED||||||Chi-squared|||Chi-square test of independence to determine if there was a significant difference between intervention arms for those who began early intervention services.||||.82
70929268|NCT03625115|141354889|EQUIVALENCE|A two-tailed t-test was done to compare the mean Bayley language scores between the groups.||||||0.69|||||||t-test, 2 sided|||||||0.69
70929269|NCT03625115|141354891|EQUIVALENCE|two tailed t-test to compare the means of factor 1 between groups||||||0.858|||||||t-test, 2 sided|||Analysis of factor 1 items from the parent engagement questionnaire. Factor 1 (Buy-in) I am open to getting EI for my child. EI can help my child. EI can teach me new ways to help my child.||||.858
70929270|NCT03625115|141354891|EQUIVALENCE|two tailed t-test to compare the means of factor 2 between groups||||||0.995|||||||t-test, 2 sided|||"Analysis of factor 2 items from the parent engagement questionnaire.~Factor 2 (early intervention consequences):~EI could have negative consequences for my child. Getting EI for my child reflects negatively on me as a parent."||||.995
70929271|NCT03625115|141354891|EQUIVALENCE|two tailed t-test to compare the means of factor 3 between groups||||||0.049|||||||t-test, 2 sided|||"Analysis of factor 3 items from the parent engagement questionnaire.~Factor 3 (Knowledge/Self-Efficacy):~I know how to get EI for my child. I understand how the EI process works. If I have questions about EI, I know who to call. 12. I know my child's rights to EI under the law."||||.049
70929272|NCT03625115|141354892|SUPERIORITY||Odds Ratio (OR)|1.87||||0.02|TWO_SIDED|95.0|1.09|3.21|||Regression, Logistic|||A logistic regression was run to determine if the intervention arm, adjusted for child sex, income, maternal education, and primary care site, was associated with the completion of early intervention referrals for families with an adverse childhood experience survey score of greater than 2.||3.21|1.09|.02
70929273|NCT01236781|141354924|EQUIVALENCE|no margin is assumed.||||||0.46||||||1 degree of freedom;|McNemar|Exact test||"To account for the paired nature of the design, McNemar's test will be used to compare the call-back rates.~H0: assumes no difference between the tests (modalities)"||||0.46
70929274|NCT01236781|141354927|EQUIVALENCE|no equivalence margin||||||0.2188||||||Due to the paired nature of the data an exact McNemar's Test is used|McNemar|Exact test||H0: no difference between the 2 modalities||||0.2188
70929275|NCT04028284|141354931|OTHER|Two-sided inferential test||||||0.02||||||Adjusted for multiple comparisons using the Holm-Bonferroni correction. The a priori threshold for statistical significance was P \< 0.05 for the primary outcome.|t-test, 2 sided|||||||0.02
70929276|NCT04028284|141354932|OTHER|Inferential two-sided test||||||0.31|||||||t-test, 2 sided|||||||0.31
70929277|NCT04028284|141354933|OTHER|Inferential two-sided test||||||0.01||||||Adjusted for multiple comparisons using the Holm-Bonferroni correction.|t-test, 2 sided|||||||0.01
70929278|NCT04028284|141354934|OTHER|Inferential two-sided test||||||0.03||||||Adjusted for multiple comparisons using the Holm-Bonferroni correction.|t-test, 2 sided|||||||0.03
71048309|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-6.8|||||TWO_SIDED|95.0|-12.76|-0.74||||||Additional serotypes - serotype 3||-0.74|-12.76|
71048310|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|3.9|||||TWO_SIDED|95.0|0.15|7.69||||||Additional serotypes - serotype 5||7.69|0.15|
70929279|NCT04028284|141354935|OTHER|Inferential two-sided test||||||0.56|||||||t-test, 2 sided|||||||0.56
70929280|NCT04028284|141354936|OTHER|Inferential two-sided test||||||0.78|||||||t-test, 2 sided|||||||0.78
70929281|NCT04028284|141354937|OTHER|Inferential two-sided test||||||0.24|||||||Fisher Exact|||||||0.24
70929282|NCT03314688|141354943|SUPERIORITY|||||||0.69|||||||t-test, 2 sided|||||||0.69
70929283|NCT03314688|141354944|SUPERIORITY|||||||0.33|||||||Chi-squared|||Comparison of Q1: In the past month, how often did you take your aromatase inhibitor (AI)/tamoxifen pills as the doctor prescribed? = 'All the time'||||0.33
70929284|NCT03314688|141354944|SUPERIORITY|||||||0.44|||||||Chi-squared|||Comparison of Q2: In the past month, how often did you forget to take one or more of your aromatase inhibitor (AI)/tamoxifen pills? = 'Never'||||0.44
70929285|NCT03314688|141354944|SUPERIORITY|||||||0.29|||||||Chi-squared|||Comparison of Q3: In the past month, how often did you decide to skip one or more of your aromatase inhibitor (AI)/tamoxifen pills? = 'Never'||||0.29
70929286|NCT03314688|141354945|SUPERIORITY|||||||0.69|||||||Chi-squared|||Comparison of Q1: In the past month, how often did you take your aromatase inhibitor (AI)/tamoxifen pills as the doctor prescribed? = 'All the time'||||0.69
70929287|NCT03314688|141354945|SUPERIORITY|||||||0.91|||||||Chi-squared|||Comparison of Q2: In the past month, how often did you forget to take one or more of your aromatase inhibitor (AI)/tamoxifen pills? = 'Never'||||0.91
70929288|NCT03314688|141354945|SUPERIORITY|||||||0.13|||||||Chi-squared|||Comparison of Q3: In the past month, how often did you decide to skip one or more of your aromatase inhibitor (AI)/tamoxifen pills? = 'Never'||||0.13
70929289|NCT05565820|141355017|SUPERIORITY||difference in proportions|-0.335|STANDARD_ERROR_OF_MEAN|0.149||0.025|TWO_SIDED|||||Alpha: .05|Z-test for difference in proportions|Z: 2.246 Cohen's d: .590|Direction of comparison: Vamousse Day 2 proportion of live lice - Nix Day 2 proportion of live lice|"Null hypothesis: At Day 2 the proportion of lice free subjects in the Vamousse Spray 'n' Go group does not exceed that in the Nix Creme Rinse Lice Treatment group.~The null hypothesis is one-tailed. However, for consistency with the practice of reporting conservative p-values in clinical studies, the two-tailed p-value will be reported."||||.025
70929290|NCT05565820|141355017|SUPERIORITY||Difference in proportions|0.348|STANDARD_ERROR_OF_MEAN|0.141||0.014|TWO_SIDED|||||Alpha: .05.|Z-test for difference in proportions|Z 2.469 Cohen's d .660|Direction of comparison: Vamousse Day 7 proportion live lice free - Nix Day 7 proportion live lice free|"Null hypothesis: At Day 7 the proportion of lice free subjects in the Vamousse Spray 'n' Go group does not exceed that in the Nix Creme Rinse Lice Treatment group.~The null hypothesis is one-tailed. However, for consistency with the practice of reporting conservative p-values in clinical studies, the two-tailed p-value will be reported."||||.014
70929291|NCT05565820|141355017|SUPERIORITY||Difference in proportions|0.283|STANDARD_ERROR_OF_MEAN|0.147||0.054|TWO_SIDED|||||Alpha: .05|Z-test for difference in proportions|Z: 1.920 Cohen's d: .513|Vamousse Day 14 proportion live lice free - Nix Day 14 proportion live lice free|"Null hypothesis: At Day 14 the proportion of lice-free subjects in the Vamousse Spray 'n' Go group does not exceed that in the Nix Creme Rinse Lice Treatment group.~The null hypothesis is one-tailed. However, for consistency with the practice of reporting conservative p-values in clinical studies, the two-tailed p-value will be reported."||||.054
71048311|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.2|||||TWO_SIDED|95.0|-3.52|3.09||||||Additional serotypes - serotype 5||3.09|-3.52|
71048312|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-4.1|||||TWO_SIDED|95.0|-7.92|-0.36||||||Additional serotypes - serotype 5||-0.36|-7.92|
71048313|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|2.5|||||TWO_SIDED|95.0|0.12|5.23||||||Additional serotypes - serotype 6A||5.23|0.12|
71048314|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.2|||||TWO_SIDED|95.0|-2.22|1.86||||||Additional serotypes - serotype 6A||1.86|-2.22|
70929292|NCT05565820|141355018|SUPERIORITY|"To check on the effect of the non-normality of the change proportions, the nonparametric Mann-Whitney test was also performed.~The null hypothesis is one-tailed. However, for consistency with the practice of reporting conservative p-values in clinical studies, the two-tailed p-value will be reported."|Mean Difference (Final Values)|0.295|STANDARD_ERROR_OF_MEAN|0.1148||0.02|TWO_SIDED|95.0|0.052|0.537||Alpha = .05 t: 2.567 df (adjusted, see comment below): 16.83 Mann-Whitney Z: 2.830 p(2-tailed) of Mann-Whitney Z: .005 Cohen's d = 1.023|t-test, 2 sided|Degrees of freedom for the t-test were adjusted for inequality of variances between the groups using the Satterthwaite correction: df(adj) = 16.83|Direction of comparison: Vamousse prop. reduction in live lice count from Day O - Nix prop. reduction in live lice count from Day O|"Null hypothesis: At Day 2 the mean proportion of decrease from Day 0 in the number of live lice in the Vamousse group does not exceed that in the Nix group.~The distribution of the Day 0 to Day 2 change proportions deviated significantly from normality by the Shapiro-Wilk test for both the Vamousse and combined samples. However, the t-test is robust to such departures from normality for samples of this size and was used to compare the two groups on the mean change proportions."||.537|.052|.020
70941528|NCT00733226|141383810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15|STANDARD_ERROR_OF_MEAN|0.52||0.05|TWO_SIDED|95.0|-3.2|-1.1||P value was not need to adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||The sample size was computed to prove that a 30% decrease of the rate of virus provoked wheezing attacks in the OM-85 group compared with placebo is statistically significant. Approximately 29 analyzable participants in each group were required, with α=0.05 and β=0.10 (ie, with a power of 90%), respectively. The difference of 30% was taken from both pilot study and clinical experience. Sample size estimation was performed by using NCSS and PASS 2000 software.||-1.10|-3.20|0.05
71013867|NCT01945034|141534110|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.2||||0.196|TWO_SIDED|95.0|-5.64|1.16|||ANOVA|||Weight Bearing over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||1.16|-5.64|0.196
71013868|NCT01945034|141534110|SUPERIORITY_OR_OTHER||LS Mean Difference|24.9||||0.03|TWO_SIDED|95.0|2.49|47.28|||ANOVA|p-value \<=0.05 for treatment effects||At Rest over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||47.28|2.49|0.030
71013869|NCT01945034|141534110|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.2||||0.018|TWO_SIDED|95.0|-55.24|-5.23|||ANOVA|p-value \<=0.05 for treatment effects||At Rest over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||-5.23|-55.24|0.018
71013870|NCT01945034|141534110|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.3||||0.611|TWO_SIDED|95.0|-25.98|15.29|||ANOVA|p-value \<=0.05 for treatment effects||At Rest over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||15.29|-25.98|0.611
71013871|NCT01945034|141534110|SUPERIORITY_OR_OTHER||LS Mean Difference|13.8||||0.251|TWO_SIDED|95.0|-9.8|37.36|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||37.36|-9.80|0.251
71013872|NCT01945034|141534110|SUPERIORITY_OR_OTHER||LS Mean Difference|4.4||||0.689|TWO_SIDED|95.0|-17.37|26.26|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||26.26|-17.37|0.689
71013873|NCT01945034|141534110|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.3||||0.486|TWO_SIDED|95.0|-35.69|17.01|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||17.01|-35.69|0.486
71048315|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-2.7|||||TWO_SIDED|95.0|-5.39|-0.27||||||Additional serotypes - serotype 6A||-0.27|-5.39|
71104267|NCT03440385|141715601|SUPERIORITY||Odds Ratio (OR)|0.79||||0.563|TWO_SIDED|95.0|0.35|1.78|||Mantel Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.78|0.35|0.5630
71013874|NCT01945034|141534111|SUPERIORITY_OR_OTHER||LS Mean Difference|38.5||||0.021|TWO_SIDED|95.0|5.9|71.18|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Over 3 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||71.18|5.90|0.021
71048316|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.8|||||TWO_SIDED|95.0|-0.47|2.3||||||Additional serotypes - serotype 7F||2.30|-0.47|
71048317|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-1.12|1.18||||||Additional serotypes - serotype 7F||1.18|-1.12|
71104268|NCT00836706|141715614|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Means x 100|101.0||||||90.0|85.2|120.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||120|85.2|
71104269|NCT00836706|141715615|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Means x 100|101.0||||||90.0|88.7|114.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||114|88.7|
70929293|NCT05565820|141355018|SUPERIORITY|"The nonparametric Mann-Whitney test was also conducted to check on the effect of the non-normality of the change proportions.~The null hypothesis is one-tailed. However, for consistency with the practice of reporting conservative p-values in clinical studies, the two-tailed p-value will be reported."|Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.182||0.334|TWO_SIDED|95.0|-0.187|0.543||Alpha = .05 t: .976 df: 54 Mann-Whitney Z: 3.021 p(2-tailed) of Mann-Whitney Z: .003 Cohen's d = .294|t-test, 2 sided|Levine's test for violation of equality of variances nonsignificant; no df adjustment necessary.||"Null hypothesis: At Day 7 the proportion of decrease from baseline in the number of live lice in the Vamousse group does not exceed that in the Nix group.~The distribution of the Day 0 to Day 7 change proportions deviated significantly from normality by the Shapiro-Wilk test for both the Vamousse and combined samples. However, the t-test is robust to such departures from normality for samples of this size and was used to compare the two groups on their mean change proportions."||.543|-.187|.334
70929294|NCT05565820|141355018|SUPERIORITY|"The nonparametric Mann-Whitney test was also conducted to check on the effect of the non-normality of the change proportions.~The null hypothesis is one-tailed. However, for consistency with the practice of reporting conservative p-values in clinical studies, the two-tailed p-value will be reported."|Difference between proportions|0.235|STANDARD_ERROR_OF_MEAN|0.1034||0.037|TWO_SIDED|95.0|0.016|0.454||Alpha = .05 t: 2.276 df(adjusted, see comment below): 16.2 Mann-Whitney Z: 2.478 p(2-tailed) of Mann-Whitney Z: .013 Cohen's d = .947|t-test, 2 sided|Degrees of freedom for the t-test were adjusted for inequality of variances between the groups using the Satterthwaite correction: df(adj) = 16.2||"Null hypothesis: At Day 14 the proportion of decrease from baseline in the number of live lice in the Vamousse group does not exceed that in the Nix group.~The distribution of the Day 0 to Day 14 change proportion deviated significantly from normality by the Shapiro-Wilk test for both the Vamousse and combined samples. However, the t-test is robust to such departures from normality for samples of this size and was used to compare the two groups on the mean change proportions."||.454|.016|.037
70929295|NCT00429364|141355021|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||0.08
70929296|NCT00429364|141355022|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||0.20
71013875|NCT01945034|141534111|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.9||||0.603|TWO_SIDED|95.0|-38.02|22.12|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Over 3 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||22.12|-38.02|0.603
71013876|NCT01945034|141534111|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.5||||0.013|TWO_SIDED|95.0|-82.93|-10.05|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Over 3 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-10.05|-82.93|0.013
71013877|NCT01945034|141534112|SUPERIORITY_OR_OTHER||LS Mean Difference|87.7||||0.021|TWO_SIDED|95.0|13.48|161.85|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Over 7 days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||161.85|13.48|0.021
71013878|NCT01945034|141534112|SUPERIORITY_OR_OTHER||LS Mean Difference|11.8||||0.735|TWO_SIDED|95.0|-56.59|80.11|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Over 7 days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||80.11|-56.59|0.735
71013879|NCT01945034|141534112|SUPERIORITY_OR_OTHER||LS Mean Difference|-75.9||||0.072|TWO_SIDED|95.0|-158.73|6.93|||ANOVA|||At Rest Over 7 days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||6.93|-158.73|0.072
71013880|NCT01945034|141534112|SUPERIORITY_OR_OTHER||LS Mean Difference|46.0||||0.261|TWO_SIDED|95.0|-34.43|126.52|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing Over 7 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||126.52|-34.43|0.261
71013881|NCT01945034|141534112|SUPERIORITY_OR_OTHER||LS Mean Difference|37.3||||0.325|TWO_SIDED|95.0|-37.13|111.8|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing Over 7 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||111.80|-37.13|0.325
71013882|NCT01945034|141534112|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.7||||0.849|TWO_SIDED|95.0|-98.64|81.22|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing Over 7 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||81.22|-98.64|0.849
71013883|NCT01945034|141534113|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.042|TWO_SIDED|95.0|0.0|0.49|||ANOVA|p-value \<=0.05 for treatment effects||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.49|0.0|0.042
71013884|NCT01945034|141534113|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.114|TWO_SIDED|95.0|-0.04|0.4|||ANOVA|p-value \<=0.05 for treatment effects||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.40|-0.04|0.114
71013885|NCT01945034|141534113|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.598|TWO_SIDED|95.0|-0.34|0.2|||ANOVA|p-value \<=0.05 for treatment effects||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms.||0.20|-0.34|0.598
71048318|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.7|||||TWO_SIDED|95.0|-2.3|0.52||||||Additional serotypes - serotype 7F||0.52|-2.30|
71048319|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.0|||||TWO_SIDED|95.0|-2.91|0.8||||||Additional serotypes - serotype 19A||0.80|-2.91|
71048320|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.7|||||TWO_SIDED|95.0|-2.69|1.19||||||Additional serotypes - serotype 19A||1.19|-2.69|
71048321|NCT00444457|141605459|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.3|||||TWO_SIDED|95.0|-1.4|2.04||||||Additional serotypes - serotype 19A||2.04|-1.40|
71048322|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.1|||||TWO_SIDED|95.0|-1.61|1.81|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4||1.81|-1.61|
71048323|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.8|||||TWO_SIDED|95.0|-2.39|0.23|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4||0.23|-2.39|
71048324|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.9|||||TWO_SIDED|95.0|-2.54|0.2|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4||0.20|-2.54|
71048325|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.02|1.11|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B||1.11|-1.02|
71048326|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.03|1.04|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B||1.04|-1.03|
71048327|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.13|1.06|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B||1.06|-1.13|
71048328|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.25|1.37|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V||1.37|-1.25|
71048329|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.6|||||TWO_SIDED|95.0|-0.76|2.18|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V||2.18|-0.76|
71048330|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.5|||||TWO_SIDED|95.0|-0.87|2.18|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V||2.18|-0.87|
71048331|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-0.74|1.62|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14||1.62|-0.74|
71048332|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.03|1.04|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14||1.04|-1.03|
71048333|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.3|||||TWO_SIDED|95.0|-1.61|0.76|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14||0.76|-1.61|
71104270|NCT00836706|141715616|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Means x 100|101.0||||||90.0|88.4|114.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||114|88.4|
71048334|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.4|||||TWO_SIDED|95.0|-1.52|2.39|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C||2.39|-1.52|
71048335|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.5|||||TWO_SIDED|95.0|-2.3|1.04|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C||1.04|-2.30|
70850481|NCT01305577|141189114|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.97|||<|0.001|TWO_SIDED|95.0|-2.79|-1.15|||Mixed Models Repeated Measures|The model includes the fixed effect factors visit and treatment, the visit\*treatment interaction, and the baseline values as covariate.||||-1.15|-2.79|<0.001
71013886|NCT01945034|141534113|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.833|TWO_SIDED|95.0|-0.24|0.19|||ANOVA|p-value \<=0.05 for treatment effects||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.19|-0.24|0.833
71013887|NCT01945034|141534113|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.853|TWO_SIDED|95.0|-0.18|0.22|||ANOVA|p-value \<=0.05 for treatment effects||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.22|-0.18|0.853
71013888|NCT01945034|141534113|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.733|TWO_SIDED|95.0|-0.2|0.29|||ANOVA|p-value \<=0.05 for treatment effects||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms.||0.29|-0.20|0.733
71013889|NCT01945034|141534115|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||0.016|TWO_SIDED|95.0|1.07|1.97|||Proportional Hazards Model|p-value \<=0.05 for treatment effects||Time to First Perceptible Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the Proportional Hazards (PH) model with treatment, BLPSR, and pooled site blocks.||1.97|1.07|0.016
71013890|NCT01945034|141534115|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.022|TWO_SIDED|95.0|0.53|0.95|||Proportional Hazards Model|p-value \<=0.05 for treatment effects||Time to First Perceptible Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.||0.95|0.53|0.022
71013891|NCT01945034|141534115|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.34|0.69|||Proportional Hazards Model|p-value \<=0.05 for treatment effects||Time to First Perceptible Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.||0.69|0.34|< 0.001
71013892|NCT01945034|141534115|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.79|||<|0.001|TWO_SIDED|95.0|1.27|2.51|||Proportional Hazards Model|p-value \<=0.05 for treatment effects||Time to Meaningful Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.||2.51|1.27|< 0.001
71013893|NCT01945034|141534115|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.009|TWO_SIDED|95.0|0.41|0.88|||Proportional Hazards Model|p-value \<=0.05 for treatment effects||Time to Meaningful Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.||0.88|0.41|0.009
71013894|NCT01945034|141534115|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.34|||<|0.001|TWO_SIDED|95.0|0.22|0.52|||Proportional Hazards Model|p-value \<=0.05 for treatment effects||Time to Meaningful Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.||0.52|0.22|< 0.001
71013895|NCT01945034|141534117|SUPERIORITY_OR_OTHER|||||||0.479|||||||Cochran-Mantel-Haenszel|p-values from the Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for BLPSR and site block.||||||0.479
71013896|NCT01945034|141534117|SUPERIORITY_OR_OTHER|||||||0.279|||||||Cochran-Mantel-Haenszel|p-values from the CMH test with modified ridit scores, controlling for BLPSR and site block.||||||0.279
71013897|NCT01945034|141534117|SUPERIORITY_OR_OTHER|||||||0.129|||||||Cochran-Mantel-Haenszel|p-values from the CMH test with modified ridit scores, controlling for BLPSR and site block.||||||0.129
71013898|NCT02660489|141534140|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
71013899|NCT02660489|141534141|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||||||0.49
71013900|NCT02660489|141534142|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.50
71013901|NCT02660489|141534143|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
71013902|NCT02660489|141534144|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
71013903|NCT02660489|141534145|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
71013904|NCT02660489|141534146|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.75
71013905|NCT02660489|141534147|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||0.66
71013906|NCT00463385|141534159|SUPERIORITY_OR_OTHER_LEGACY|||||||0.092||95.0|||||Fisher Exact|||||||0.092
71013907|NCT00463385|141534159|SUPERIORITY_OR_OTHER_LEGACY|||||||0.048||95.0|||||Fisher Exact|||||||0.048
71013908|NCT00463385|141534159|SUPERIORITY_OR_OTHER_LEGACY|||||||0.758||95.0|||||Fisher Exact|||||||0.758
71013909|NCT03471507|141534233|OTHER|||||||0.46|||||||Regression, Linear|Adjusted for age and sex.||||||0.46
71013910|NCT01151085|141534239|SUPERIORITY_OR_OTHER||||||=|0.03|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between Male and Female  in the Frequency of Treatment Related Adverse Events."||||=0.030
71013911|NCT01151085|141534240|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Severity of infections. The null hypothesis is there is no difference among mild, moderate and severe in the Frequency of Treatment Related Adverse Events."||||<0.001
71013912|NCT01151085|141534241|SUPERIORITY_OR_OTHER||||||=|0.017|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Past History. The null hypothesis is there is no difference between with and without Past History in the Frequency of Treatment Related Adverse Events."||||=0.017
71013913|NCT01151085|141534242|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Statistical Analysis for Risk Factors for the Proportion of Responders to Voriconazole treatment -Severity of infections.||||<0.001
71029188|NCT01199861|141565920|SUPERIORITY_OR_OTHER||Percent Inhibition|44.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the B/Brisbane/60/2008 strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo three weeks after a single dose of seasonal influenza vaccine.||||
70929297|NCT00429364|141355023|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||0.15
70929298|NCT00429364|141355024|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||0.30
70929299|NCT00429364|141355025|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||<0.001
70929300|NCT00429364|141355026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||0.002
70929301|NCT00429364|141355027|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||0.29
70929302|NCT00429364|141355028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96|TWO_SIDED|||||Regression model adjusted for age at study visit.|Mixed Models Analysis|||||||0.96
71048336|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.9|||||TWO_SIDED|95.0|-2.87|0.74|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C||0.74|-2.87|
71048337|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.5|||||TWO_SIDED|95.0|-2.55|1.5|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F||1.50|-2.55|
71048338|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-1.1|||||TWO_SIDED|95.0|-3.06|0.57|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F||0.57|-3.06|
71048339|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.6|||||TWO_SIDED|95.0|-2.44|1.0|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F||1.00|-2.44|
70850482|NCT01305577|141189115|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Pearson's chi-square test|||||||<0.001
70929303|NCT00429364|141355029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45|TWO_SIDED||||||Mixed Models Analysis|||||||0.45
70929304|NCT00429364|141355030|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.13
70929305|NCT00429364|141355031|SUPERIORITY_OR_OTHER_LEGACY|||||||0.65|TWO_SIDED||||||Mixed Models Analysis|||||||0.65
70929306|NCT00429364|141355032|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.13
70929307|NCT00429364|141355033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.82|TWO_SIDED||||||Mixed Models Analysis|||||||0.82
70929308|NCT00429364|141355034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64|TWO_SIDED||||||Mixed Models Analysis|||||||0.64
70850483|NCT01305577|141189115|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Pearson's chi-square test|||||||<0.001
70929309|NCT00429364|141355035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.49|TWO_SIDED||||||Mixed Models Analysis|||||||0.49
70929310|NCT00429364|141355036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.59|TWO_SIDED||||||Mixed Models Analysis|||||||0.59
70929311|NCT00429364|141355038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|TWO_SIDED||||||Log Rank|||||||0.16
70929312|NCT00429364|141355040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|TWO_SIDED||||||Log Rank|||||||0.13
70929313|NCT00429364|141355042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.32|TWO_SIDED||||||Log Rank|||||||0.32
70929314|NCT00429364|141355044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1|TWO_SIDED||||||Log Rank|||||||0.10
70929315|NCT04070573|141355052|SUPERIORITY||Risk Difference (RD)|0.035||||0.28|TWO_SIDED||||||Chi-squared||Risk difference direction = 81mg arm minus 162mg arm.|||||0.28
70929316|NCT04070573|141355053|SUPERIORITY||Risk Difference (RD)|0.035||||0.31|TWO_SIDED||||||Chi-squared||Risk difference direction = 81mg arm minus 162mg arm.|||||0.31
70929317|NCT04070573|141355054|SUPERIORITY||Risk Difference (RD)|0.019||||0.61|TWO_SIDED||||||Chi-squared||Risk difference direction = 81mg arm minus 162mg arm.|||||0.61
70929318|NCT04070573|141355057|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.72|TWO_SIDED||||||t-test, 2 sided|||||||0.72
70929319|NCT05237284|141355071|SUPERIORITY|||||||0.6999|||||||Wilcoxon (Mann-Whitney)|||CAFS at Week 24 was analyzed using the Wilcoxon-Mann-Whitney test to compare mean scores between the treatment groups at Week 24.||||0.6999
70929320|NCT05237284|141355074|SUPERIORITY||LS Mean Difference|0.52||||0.2182|TWO_SIDED|95.0|-0.31|1.35|||MMRM|||Analysis was performed using MMRM including treatment group, visit, randomization strata of the geographic region, ALS onset region, use of riluzole, use of edaravone, use of the combination of sodium phenylbutyrate and taurursodiol, treatment-by-visit interaction, disease duration, baseline ALSFRS-R score, baseline NfL, disease duration-by-visit interaction, and baseline ALSFRS-R score-by-visit interaction.||1.350|-0.310|0.2182
70929321|NCT05237284|141355075|SUPERIORITY||LS Mean Difference|0.419||||0.8134|TWO_SIDED|95.0|-3.075|3.914|||MMRM|||Analysis was performed using MMRM including treatment group, visit, randomization strata of the geographic region, ALS onset region, use of riluzole, use of edaravone, use of the combination of sodium phenylbutyrate and taurursodiol, treatment-by-visit interaction, disease duration, baseline SVC, baseline NfL, disease duration-by-visit interaction, baseline NfL-by-visit interaction, and baseline SVC-by-visit interaction.||3.914|-3.075|0.8134
71048340|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-1.21|2.05|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F||2.05|-1.21|
71048341|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|1.1|||||TWO_SIDED|95.0|-0.52|3.16|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F||3.16|-0.52|
71048342|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.8|||||TWO_SIDED|95.0|-1.05|2.87|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F||2.87|-1.05|
71048343|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.9|||||TWO_SIDED|95.0|-0.17|2.53|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1||2.53|-0.17|
71048344|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.8|||||TWO_SIDED|95.0|-0.2|2.44|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1||2.44|-0.20|
71048345|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.79|1.66|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1||1.66|-1.79|
71048346|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|2.8|||||TWO_SIDED|95.0|-2.85|8.55|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3||8.55|-2.85|
71048347|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-4.9|||||TWO_SIDED|95.0|-9.99|0.21|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3||0.21|-9.99|
71048348|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-7.7|||||TWO_SIDED|95.0|-13.14|-2.37|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3||-2.37|-13.14|
71048349|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-1.0|1.84|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5||1.84|-1.00|
71048350|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.27|1.3|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5||1.30|-1.27|
71048351|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.3|||||TWO_SIDED|95.0|-1.84|1.02|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5||1.02|-1.84|
71048352|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.04|1.08|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A||1.08|-1.04|
71048353|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-0.76|1.56|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A||1.56|-0.76|
71048354|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-0.83|1.56|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A||1.56|-0.83|
71048355|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.6|||||TWO_SIDED|95.0|-0.47|2.09|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F||2.09|-0.47|
70850484|NCT02910986|141189165|SUPERIORITY||||||>|0.05|||||||Chi-squared|||The percentage with improved knowledge (defined as having an incorrect response at T0 and a correct response at T1) was compared between study groups with chi-square tests.||||> 0.05
71048356|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.6|||||TWO_SIDED|95.0|-0.48|2.0|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F||2.00|-0.48|
71048357|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.59|1.49|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F||1.49|-1.59|
71048358|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.04|1.09|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A||1.09|-1.04|
71048359|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.05|1.04|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A||1.04|-1.05|
71048360|NCT00444457|141605460|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.09|1.07|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A||1.07|-1.09|
71048361|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-1.4|||||TWO_SIDED|95.0|-6.52|3.63|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4||3.63|-6.52|
71048362|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-6.7|||||TWO_SIDED|95.0|-11.3|-2.15|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4||-2.15|-11.30|
71048363|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-5.2|||||TWO_SIDED|95.0|-9.85|-0.79|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4||-0.79|-9.85|
71048364|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-1.19|2.07|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B||2.07|-1.19|
71048365|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.3|||||TWO_SIDED|95.0|-1.69|1.06|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B||1.06|-1.69|
71048366|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.6|||||TWO_SIDED|95.0|-2.27|0.75|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B||0.75|-2.27|
71048367|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-3.8|||||TWO_SIDED|95.0|-9.46|1.82|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V||1.82|-9.46|
71048368|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-4.7|||||TWO_SIDED|95.0|-10.24|0.76|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V||0.76|-10.24|
71048369|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.9|||||TWO_SIDED|95.0|-6.3|4.41|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V||4.41|-6.30|
70929322|NCT05237284|141355076|SUPERIORITY||Ratio of the LS Geometric Mean Ratios|0.961||||0.2356|TWO_SIDED|95.0|0.899|1.027|||MMRM|||Analysis was performed using MMRM including treatment group, visit, randomization strata of the geographic region, ALS onset region, use of riluzole, use of edaravone, use of the combination of sodium phenylbutyrate and taurursodiol, treatment-by-visit interaction, disease duration, log transformed baseline NfL, disease duration-by-visit interaction, and log transformed baseline NfL-by-visit interaction.||1.027|0.899|0.2356
70941529|NCT00733226|141383811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.08|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|-3.06|-1.01||P value was not need to adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||-1.01|-3.06|<0.001
71048370|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.2|||||TWO_SIDED|95.0|-2.14|1.73|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14||1.73|-2.14|
71048371|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-1.69|2.39|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14||2.39|-1.69|
71048372|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.5|||||TWO_SIDED|95.0|-1.46|2.59|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14||2.59|-1.46|
71048373|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-5.5|||||TWO_SIDED|95.0|-11.17|0.2|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C||0.20|-11.17|
70850485|NCT02910986|141189166|SUPERIORITY|||||||0.56||||||The priori threshold for statistical significance was 0.05|Chi-squared|||||||0.56
71048374|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-10.0|||||TWO_SIDED|95.0|-15.31|-4.7|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C||-4.70|-15.31|
71048375|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-4.5|||||TWO_SIDED|95.0|-9.55|0.46|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C||0.46|-9.55|
71048376|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.8|||||TWO_SIDED|95.0|-4.23|2.52|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F||2.52|-4.23|
71048377|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-3.3|||||TWO_SIDED|95.0|-6.35|-0.4|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F||-0.40|-6.35|
71048378|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-2.4|||||TWO_SIDED|95.0|-5.44|0.33|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F||0.33|-5.44|
71048379|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.5|||||TWO_SIDED|95.0|-3.67|4.8|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F||4.80|-3.67|
70929323|NCT05237284|141355077|SUPERIORITY||LS Mean difference|-0.005||||0.9565|TWO_SIDED|95.0|-0.193|0.183|||MMRM|||Analysis was performed using MMRM including treatment group, visit, randomization strata of the geographic region, ALS onset region, use of riluzole, use of edaravone, use of the combination of sodium phenylbutyrate and taurursodiol, treatment-by-visit interaction, disease duration, baseline megascore, baseline NfL, disease duration-by-visit interaction, baseline NfL-by-visit interaction and baseline megascore-by-visit interaction.||0.183|-0.193|0.9565
70929324|NCT05237284|141355082|SUPERIORITY||Least Square (LS) Mean Difference|-0.414||||0.5289|TWO_SIDED|95.0|-1.706|0.878|||MMRM|||Analysis was performed using MMRM including treatment group, visit, randomization strata of the geographic region, ALS onset region, use of riluzole, use of edaravone, use of the combination of sodium phenylbutyrate and taurursodiol, treatment-by-visit interaction, disease duration, baseline ALSFRS-R score, baseline serum neurofilament light chain (NfL), disease duration-by-visit interaction, baseline NfL-by-visit interaction and baseline ALSFRS-R score-by-visit interaction.||0.878|-1.706|0.5289
70929325|NCT05237284|141355083|SUPERIORITY|||||||0.183|||||||ANCOVA|||Analysis was performed using rank analysis of covariance (ANCOVA) model including treatment group, randomization strata of the geographic region of the study site, ALS onset region (bulbar or other areas), use of riluzole (yes or no), use of edaravone (yes or no), use of the combination of sodium phenylbutyrate and taurursodiol (yes or no), disease duration (from first symptom onset to the screening visit), baseline ALSFRS-R score and baseline NfL.||||0.1830
70929326|NCT03213873|141355112|SUPERIORITY||Interaction effect time x group|0.4||||0.57|TWO_SIDED|95.0|-1.0|1.9|||Mixed Models Analysis|||||1.9|-1.0|0.57
70929327|NCT03213873|141355113|SUPERIORITY||Interaction effect time x group|0.05||||0.25|TWO_SIDED|95.0|-0.03|0.12|||Mixed Models Analysis|||||0.12|-0.03|0.25
70929328|NCT03213873|141355114|SUPERIORITY||Interaction effect time x group|0.2||||0.75|TWO_SIDED|95.0|-0.8|1.1|||Mixed Models Analysis|||||1.1|-0.8|0.75
70929329|NCT02998528|141355153|SUPERIORITY||Cox Proportional Hazard|0.63||||0.0052|TWO_SIDED|97.38|0.43|0.91|||Log Rank|Stratified by PD-L1 (≥ 1% vs \<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)||||0.91|0.43|0.0052
70929330|NCT02998528|141355154|SUPERIORITY||% Difference|21.6|||||TWO_SIDED|99.0|13.0|30.3|||||Strata adjusted difference (Arm C - Concurrent Arm B) based on the CMH method of weighting. Stratified by PD-L1 (≥ 1% vs \<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)|||30.3|13.0|
70929331|NCT02998528|141355154|SUPERIORITY||Odds Ratio (OR)|13.94|||<|0.0001|TWO_SIDED|99.0|3.49|55.75|||Cochran-Mantel-Haenszel||Strata adjusted odds ratio (Arm C over Concurrent Arm B) the Mantel-Haenszel method. Stratified by PD-L1 (≥ 1% vs \<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)|||55.75|3.49|<0.0001
70929332|NCT02998528|141355155|SUPERIORITY||% Difference|27.9|||||TWO_SIDED|95.0|19.6|36.1|||||Strata adjusted difference (Arm C - Concurrent Arm B) based on the CMH method of weighting. Stratified by PD-L1 (≥ 1% vs \<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)|||36.1|19.6|
70929333|NCT02998528|141355155|SUPERIORITY||Odds Ratio (OR)|5.7|||||TWO_SIDED|95.0|3.16|10.26|||||Stratified by PD-L1 (≥ 1% vs \<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)|||10.26|3.16|
70929334|NCT02998528|141355157|SUPERIORITY||Hazard Ratio (HR)|0.53|||||TWO_SIDED|95.0|0.36|0.77|||||Stratified by: PD-L1 status (≥ 1% vs \<1%/not evaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)|||0.77|0.36|
70929335|NCT06029452|141355158|NON_INFERIORITY|Non-inferiority margin was 0.10.|Sensitivity|0.853|||||ONE_SIDED|95.0|0.815||||||Sensitivity was defined as the probability that an individual with the disease in the population were screen positive for disease by the algorithm (TP). Sensitivity = TP / (TP + FN).||||0.815|
70929336|NCT06029452|141355158|NON_INFERIORITY|Non-inferiority margin was 0.10.|Specificity|0.584|||||ONE_SIDED|95.0|0.539||||||Sensitivity was defined as the probability that an individual with the disease in the population were screen positive for disease by the algorithm (TP). Sensitivity = TP / (TP + FN).||||0.539|
70929337|NCT02575950|141355169|SUPERIORITY||Mean Difference (Final Values)|-9.34|||<|0.001|TWO_SIDED|95.0|-14.71|-3.96|||ANCOVA|||Least square mean values and difference is from ANCOVA model with treatment as fixed effect and baseline total lesion count as covariate and participants as random effect. 100 simulations of monotone multiple imputation is performed. Summary statistics are found across these 100 simulations.||-3.96|-14.71|<.001
70929338|NCT03209973|141355181|OTHER||||||<|0.0001||||||1-sided p-value was based on exact test of BGB-A317 versus historical rate of 0.35|Exact Binomial Test|Comparison with historical control values||||||<0.0001
70929339|NCT05218096|141355189|OTHER|Difference|Difference|-7.1||||0.6797|TWO_SIDED|90.0|-28.8|15.0|||Barnard's Unconditional Exact Test||CI calculated using the Chan and Zhang method.|||15.0|-28.8|0.6797
70929340|NCT05218096|141355189|OTHER|Difference|Difference|-7.1||||0.7341|TWO_SIDED|90.0|-34.8|19.3|||Barnard's Unconditional Exact Test||CI calculated using the Chan and Zhang method.|||19.3|-34.8|0.7341
70850486|NCT02910986|141189167|SUPERIORITY||||||>|0.05||||||The priori threshold for statistical significance was 0.05.|Chi-squared|||||||> 0.05
70850487|NCT02910986|141189167|OTHER||difference between EC and UC|2.6|||||TWO_SIDED|98.3|-6.0|11.2||||||||11.2|-6.0|
70929341|NCT05256654|141355240|SUPERIORITY||Mean Difference (Net)|-2.8|STANDARD_ERROR_OF_MEAN|6.92||0.691|TWO_SIDED|95.0|-15.5|11.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (Triglycerides (TG) \<250 milligram per deciliter (mg/dL) or \>=250 mg/dL at screening), and the interaction between treatment and time.|||11.9|-15.5|0.691
71048380|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|1.9|||||TWO_SIDED|95.0|-2.38|6.28|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F||6.28|-2.38|
71029189|NCT01199861|141565921|SUPERIORITY_OR_OTHER||Percent Inhibition|38.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the A/California/7/09 (H1N1) strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo six weeks after a single dose of seasonal influenza vaccine.||||
71104271|NCT02541591|141715618|SUPERIORITY||Median ratio of final values|1.37||||0.0881|TWO_SIDED|95.0|0.95|1.98|||ANOVA|due to non normality of the residuals the data were log-transformed prior to the anova|the estimated mean difference obtained using the anova on the log-transformed data was back transformed thus yielding a ratio of median values|missing data were accounted for by multiple imputation||1.98|0.95|0.0881
71104272|NCT03898180|141715645|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.4107|TWO_SIDED|95.0|0.72|1.14||Two-sided p-value based on log rank test stratified on chemotherapy ineligibility, programmed cell death ligand 1 (PD-L1) CPS, and ECOG performance status (PS).|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified on chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|||1.14|0.72|0.4107
71104273|NCT03898180|141715646|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.3505|TWO_SIDED|95.0|0.87|1.48||Two-sided p-value based on log rank test stratified on chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified on chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|||1.48|0.87|0.3505
71104274|NCT03898180|141715647|SUPERIORITY||Difference in Percentage|4.1|||||TWO_SIDED|95.0|-4.0|12.2|||||Based on Miettinen \& Nurminen method stratified on chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|||12.2|-4.0|
71104275|NCT03898180|141715650|OTHER||Difference in least squares means|-3.07||||0.182|TWO_SIDED|95.0|-7.57|1.44||Two-sided p-value based on log rank test stratified on chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|cLDA model||Based on a constrained longitudinal data analysis (cLDA) model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|||1.44|-7.57|0.182
71104276|NCT03898180|141715651|OTHER||Hazard Ratio (HR)|1.64||||0.0005|TWO_SIDED|95.0|1.24|2.16||Two-sided p-value based on log rank test stratified on chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|||2.16|1.24|0.0005
71104277|NCT00928668|141715666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.157|STANDARD_ERROR_OF_MEAN|0.252|<|0.0001|TWO_SIDED|95.0|0.657|1.657|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 2 mcg minus Placebo|||1.657|0.657|<0.0001
71029190|NCT01199861|141565921|SUPERIORITY_OR_OTHER||Percent Inhibition|-28.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the A/Perth/16/2009 (H3N2) strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo six weeks after a single dose of seasonal influenza vaccine.||||
71029191|NCT01199861|141565921|SUPERIORITY_OR_OTHER||Percent Inhibition|48.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the B/Brisbane/60/2008 strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo six weeks after a single dose of seasonal influenza vaccine.||||
71029192|NCT00669864|141565932|SUPERIORITY_OR_OTHER||Estimated mean|-1.303|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|-1.414|-1.192||A significant mean HbA1c decrease was to be declared if H0 is rejected at a significance level of 2.5%.|t-test, 1 sided|||The null hypothesis (H0): HbA1c after 16 weeks - HbA1c at baseline ≥ 0% against the alternative hypothesis (H1): HbA1c after 16 weeks - HbA1c at baseline \< 0%. If H0 rejected at a significance level of 2.5%, declare a significant mean HbA1c decrease||-1.192|-1.414|<0.0001
71029193|NCT01822548|141565987|OTHER||||||<|0.05|||||||Regression, Linear|Generalized linear model (GLM)||||||<0.05
71029194|NCT01822548|141565987|SUPERIORITY||Slope|0.362|||<|0.05|TWO_SIDED|95.0|0.028|0.695|||ANOVA|adjustment for baseline value of EPC||||0.695|0.028|<0.05
71029195|NCT01822548|141565988|SUPERIORITY||Slope|-0.067|||<|0.05|TWO_SIDED|95.0|-0.358|0.224|||ANOVA|||||0.224|-0.358|<0.05
71029196|NCT02809183|141565990|OTHER|Single-group test|Group LS mean|-0.2|STANDARD_ERROR_OF_MEAN|0.4||0.5547|TWO_SIDED|95.0|-0.9|0.5||The null hypothesis is that the mean change from baseline within the Pooled Placebo treatment group = 0 mEq/L.|Mixed Models Analysis|||||0.5|-0.9|0.5547
71029197|NCT02809183|141565990|OTHER|Single-group test|Group LS mean|3.2|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.4|4.0||The null hypothesis is that the mean change from baseline within the 1.5g TRC101 BID group = 0 mEq/L|Mixed Models Analysis|||The null hypothesis is that the mean change from baseline within the 1.5g TRC101 BID treatment group = 0 mEq/L.||4.0|2.4|< 0.0001
71029198|NCT02809183|141565990|OTHER|Single-group test|Group LS mean|3.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.2|3.8||The null hypothesis is the 3g TRC101 BID treatment group mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||3.8|2.2|< 0.0001
71029199|NCT02809183|141565990|OTHER|Single-group test|Group LS mean|3.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.9|4.5||The null hypothesis is the 4.5g TRC101 BID treatment group mean change from baseline = 0 mEq/L|Mixed Models Analysis|||||4.5|2.9|< 0.0001
70929342|NCT05256654|141355240|SUPERIORITY||Mean Difference (Net)|-14.3|STANDARD_ERROR_OF_MEAN|4.98||0.008|TWO_SIDED|95.0|-23.6|-3.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-3.9|-23.6|0.008
71048381|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|1.4|||||TWO_SIDED|95.0|-3.06|5.82|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F||5.82|-3.06|
71048382|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.8|||||TWO_SIDED|95.0|-3.34|5.08|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1||5.08|-3.34|
71048383|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-2.6|||||TWO_SIDED|95.0|-6.39|1.18|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1||1.18|-6.39|
71048384|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-3.4|||||TWO_SIDED|95.0|-7.45|0.46|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1||0.46|-7.45|
71048385|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|1.6|||||TWO_SIDED|95.0|-5.2|8.55|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3||8.55|-5.20|
71104278|NCT00928668|141715666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.711|STANDARD_ERROR_OF_MEAN|0.255|<|0.0001|TWO_SIDED|95.0|1.205|2.217|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 5 mcg minus Placebo|||2.217|1.205|<0.0001
71104279|NCT00928668|141715666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.443|STANDARD_ERROR_OF_MEAN|0.248|<|0.0001|TWO_SIDED|95.0|1.952|2.935|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 10 mcg minus Placebo|||2.935|1.952|<0.0001
71104280|NCT00928668|141715666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.984|STANDARD_ERROR_OF_MEAN|0.251|<|0.0001|TWO_SIDED|95.0|2.486|3.483|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Form 20 mcg minus Placebo|||3.483|2.486|<0.0001
71104281|NCT00928668|141715667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.139|STANDARD_ERROR_OF_MEAN|0.249|<|0.0001|TWO_SIDED|95.0|1.645|2.633|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 2 mcg minus Placebo|||2.633|1.645|<0.0001
71048386|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-4.8|||||TWO_SIDED|95.0|-11.79|2.16|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3||2.16|-11.79|
71048387|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-6.5|||||TWO_SIDED|95.0|-13.51|0.54|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3||0.54|-13.51|
71048388|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|3.1|||||TWO_SIDED|95.0|-0.84|7.13|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5||7.13|-0.84|
71048389|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.5|||||TWO_SIDED|95.0|-3.14|4.11|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5||4.11|-3.14|
71048390|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-2.6|||||TWO_SIDED|95.0|-6.72|1.4|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5||1.40|-6.72|
71104282|NCT00928668|141715667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.636|STANDARD_ERROR_OF_MEAN|0.252|<|0.0001|TWO_SIDED|95.0|2.135|3.136|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 5 mcg minus Placebo|||3.136|2.135|<0.0001
71104283|NCT00928668|141715667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.56|STANDARD_ERROR_OF_MEAN|0.245|<|0.0001|TWO_SIDED|95.0|3.074|4.046|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 10 mcg minus Placebo|||4.046|3.074|<0.0001
71104284|NCT00928668|141715667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.224|STANDARD_ERROR_OF_MEAN|0.249|<|0.0001|TWO_SIDED|95.0|3.731|4.717|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Form 20 mcg minus Placebo|||4.717|3.731|<0.0001
71104285|NCT00928668|141715668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.025|STANDARD_ERROR_OF_MEAN|0.296|<|0.0001|TWO_SIDED|95.0|1.437|2.613|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 2 mcg minus Placebo|||2.613|1.437|<0.0001
71013914|NCT06104423|141534256|SUPERIORITY||Mean difference pre vs post treatment|-19.2|STANDARD_DEVIATION|8.62|<|0.001|TWO_SIDED|95.0|-26.0|-14.0|||paired t-test|||Primary endpoint, verified on the single cohort of patients who completed the monotherapy run-in period, is calculated as the mean difference in sitting systolic blood pressure between Visit 2 (Week 0, Baseline Visit of the combination therapy) and Visit 5 (Week 12, End of Study Visit). This is not a comparison of two different arms, but a comparison of two measurements taken from the same patient treated with combination therapy (single arm paired pre- vs. post-combination therapy comparison)||-14.0|-26.0|< 0.001
71013915|NCT00750061|141534257|SUPERIORITY_OR_OTHER|||||||0.343|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change light touch score (wk6-d0)||||0.343
71013916|NCT00750061|141534257|SUPERIORITY_OR_OTHER|||||||0.69|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change light touch score (m6-d0)||||0.69
71013917|NCT00750061|141534257|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change pin-prick score (wk6-d0)||||1
71048391|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.9|||||TWO_SIDED|95.0|-0.87|3.02|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A||3.02|-0.87|
71048392|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.62|1.71|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A||1.71|-1.62|
71048393|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.9|||||TWO_SIDED|95.0|-3.0|0.92|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A||0.92|-3.00|
71048394|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|1.9|||||TWO_SIDED|95.0|-0.62|4.67|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F||4.67|-0.62|
71048395|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.5|||||TWO_SIDED|95.0|-2.67|1.55|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F||1.55|-2.67|
71048396|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-2.4|||||TWO_SIDED|95.0|-5.11|-0.01|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F||-0.01|-5.11|
71013918|NCT00750061|141534257|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change pin-prick score (m6-d0)||||0.32
71013919|NCT00750061|141534257|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change motor score (wk6-d0)||||1
71013920|NCT00750061|141534257|SUPERIORITY_OR_OTHER|||||||0.582|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change motor score (m6-d0)||||0.582
71013921|NCT00750061|141534258|SUPERIORITY_OR_OTHER|||||||0.257|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||FIM change (Wk6 - D0)||||0.257
71013922|NCT00750061|141534258|SUPERIORITY_OR_OTHER|||||||0.168|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||FIM change (M6 - D0)||||0.168
71013923|NCT00750061|141534258|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VAS change (Wk6 - D0)||||0.013
71013924|NCT00750061|141534258|SUPERIORITY_OR_OTHER|||||||0.137|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VAS change (M6 - D0)||||0.137
71013925|NCT03246152|141534290|OTHER||||||>|0.05|||||||Pearson's correlation coefficient|||Correlation between change in BCVA and the pre treatment, post treatment, and change in vascular density following 3-6 injections was performed.||||>0.05
71048397|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.6|||||TWO_SIDED|95.0|-0.45|2.1|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A||2.10|-0.45|
71048398|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-0.75|1.58|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A||1.58|-0.75|
71048399|NCT00444457|141605462|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.3|||||TWO_SIDED|95.0|-1.86|1.05|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A||1.05|-1.86|
71013926|NCT04753606|141534312|SUPERIORITY||Least Squares (LS) Means|-32.96|STANDARD_ERROR_OF_MEAN|4.943|<|0.0001|TWO_SIDED|95.0|-44.03|-21.9|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-21.90|-44.03|<.0001
71013927|NCT04753606|141534312|SUPERIORITY||Least Squares (LS) Means|-39.18|STANDARD_ERROR_OF_MEAN|4.927|<|0.0001|TWO_SIDED|95.0|-50.21|-28.15|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-28.15|-50.21|<.0001
71013928|NCT04753606|141534313|SUPERIORITY||Least Squares (LS) Means|-32.96|STANDARD_ERROR_OF_MEAN|4.943|<|0.0001|TWO_SIDED|95.0|-44.03|-21.9|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-21.90|-44.03|<.0001
71013929|NCT04753606|141534313|SUPERIORITY||Least Squares (LS) Means|-39.18|STANDARD_ERROR_OF_MEAN|4.927|<|0.0001|TWO_SIDED|95.0|-50.21|-28.15|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-28.15|-50.21|<.0001
71013930|NCT04753606|141534314|SUPERIORITY||Least Squares (LS) Means|-32.96|STANDARD_ERROR_OF_MEAN|4.943|<|0.0001|TWO_SIDED|95.0|-44.03|-21.9|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-21.90|-44.03|<.0001
71013931|NCT04753606|141534314|SUPERIORITY||Least Squares (LS) Means|-39.18|STANDARD_ERROR_OF_MEAN|4.927|<|0.0001|TWO_SIDED|95.0|-50.21|-28.15|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-28.15|-50.21|<.0001
71013932|NCT04753606|141534315|SUPERIORITY||Least Squares (LS) Means|-28.94|STANDARD_ERROR_OF_MEAN|4.643|<|0.0001|TWO_SIDED|95.0|-38.14|-19.74|||ANCOVA|||||-19.74|-38.14|<.0001
71048400|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.02|||||TWO_SIDED|95.0|-0.1|0.13|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4||0.13|-0.10|
71048401|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.29|||||TWO_SIDED|95.0|-0.41|-0.17|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4||-0.17|-0.41|
70929343|NCT05256654|141355240|SUPERIORITY||Mean Difference (Net)|-8.3|STANDARD_ERROR_OF_MEAN|5.36||0.14|TWO_SIDED|95.0|-18.3|2.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||2.9|-18.3|0.140
71048402|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.31|||||TWO_SIDED|95.0|-0.43|-0.19|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4||-0.19|-0.43|
71048403|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.18|||||TWO_SIDED|95.0|0.06|0.3|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B||0.30|0.06|
71048404|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.12|||||TWO_SIDED|95.0|0.0|0.23|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B||0.23|-0.00|
70929344|NCT05256654|141355241|SUPERIORITY||Mean Difference (Net)|-54.3|STANDARD_ERROR_OF_MEAN|5.08|<|0.001|TWO_SIDED|95.0|-63.3|-43.1|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-43.1|-63.3|<.001
70929345|NCT05256654|141355241|SUPERIORITY||Mean Difference (Net)|-69.8|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|-74.8|-63.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-63.9|-74.8|<.001
70929346|NCT05256654|141355241|SUPERIORITY||Mean Difference (Net)|-76.6|STANDARD_ERROR_OF_MEAN|2.13|<|0.001|TWO_SIDED|95.0|-80.4|-72.0|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-72.0|-80.4|<.001
71013933|NCT04753606|141534315|SUPERIORITY||Least Squares (LS) Means|-40.07|STANDARD_ERROR_OF_MEAN|4.591|<|0.0001|TWO_SIDED|95.0|-49.16|-30.97|||ANCOVA|||||-30.97|-49.16|<.0001
71013934|NCT04753606|141534316|SUPERIORITY||Least Squares (LS) Means|-28.94|STANDARD_ERROR_OF_MEAN|4.643|<|0.0001|TWO_SIDED|95.0|-38.14|-19.74|||ANCOVA|||||-19.74|-38.14|<.0001
71013935|NCT04753606|141534316|SUPERIORITY||Least Squares (LS) Means|-40.07|STANDARD_ERROR_OF_MEAN|4.591|<|0.0001|TWO_SIDED|95.0|-49.16|-30.97|||ANCOVA|||||-30.97|-49.16|<.0001
71013936|NCT04753606|141534317|SUPERIORITY||Least Squares (LS) Means|-28.94|STANDARD_ERROR_OF_MEAN|4.643|<|0.0001|TWO_SIDED|95.0|-38.14|-19.74|||ANCOVA|||||-19.74|-38.14|<.0001
71013937|NCT04753606|141534317|SUPERIORITY||Least Squares (LS) Means|-40.07|STANDARD_ERROR_OF_MEAN|4.591|<|0.0001|TWO_SIDED|95.0|-49.16|-30.97|||ANCOVA|||||-30.97|-49.16|<.0001
71013938|NCT04753606|141534318|SUPERIORITY||Least Squares (LS) Means|-18.26|STANDARD_ERROR_OF_MEAN|3.657|<|0.0001|TWO_SIDED|95.0|-25.51|-11.02|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-11.02|-25.51|<.0001
71013939|NCT04753606|141534318|SUPERIORITY||Least Squares (LS) Means|-23.99|STANDARD_ERROR_OF_MEAN|3.65|<|0.0001|TWO_SIDED|95.0|-31.22|-16.76|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-16.76|-31.22|<.0001
71013940|NCT04753606|141534319|SUPERIORITY||Least Squares (LS) Means|-18.26|STANDARD_ERROR_OF_MEAN|3.657|<|0.0001|TWO_SIDED|95.0|-25.51|-11.02|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-11.02|-25.51|<.0001
71013941|NCT04753606|141534319|SUPERIORITY||Least Squares (LS) Means|-23.99|STANDARD_ERROR_OF_MEAN|3.65|<|0.0001|TWO_SIDED|95.0|-31.22|-16.76|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-16.76|-31.22|<.0001
71013942|NCT04753606|141534320|SUPERIORITY||Least Squares (LS) Means|-18.26|STANDARD_ERROR_OF_MEAN|3.657|<|0.0001|TWO_SIDED|95.0|-25.51|-11.02|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-11.02|-25.51|<.0001
71013943|NCT04753606|141534320|SUPERIORITY||Least Squares (LS) Means|-23.99|STANDARD_ERROR_OF_MEAN|3.65|<|0.0001|TWO_SIDED|95.0|-31.22|-16.76|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-16.76|-31.22|<.0001
71013944|NCT04753606|141534321|SUPERIORITY||Least Squares (LS) Means|-30.54|STANDARD_ERROR_OF_MEAN|4.503|<|0.0001|TWO_SIDED|95.0|-39.46|-21.62|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-21.62|-39.46|<.0001
71013945|NCT04753606|141534321|SUPERIORITY||Least Squares (LS) Means|-36.03|STANDARD_ERROR_OF_MEAN|4.488|<|0.0001|TWO_SIDED|95.0|-44.92|-27.14|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-27.14|-44.92|<.0001
71013946|NCT04753606|141534322|SUPERIORITY||Least Squares (LS) Means|-30.54|STANDARD_ERROR_OF_MEAN|4.503|<|0.0001|TWO_SIDED|95.0|-39.46|-21.62|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-21.62|-39.46|<.0001
71013947|NCT04753606|141534322|SUPERIORITY||Least Squares (LS) Means|-36.03|STANDARD_ERROR_OF_MEAN|4.488|<|0.0001|TWO_SIDED|95.0|-44.92|-27.14|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-27.14|-44.92|<.0001
71013948|NCT04753606|141534323|SUPERIORITY||Least Squares (LS) Means|-30.54|STANDARD_ERROR_OF_MEAN|4.503|<|0.0001|TWO_SIDED|95.0|-39.46|-21.62|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-21.62|-39.46|<.0001
71013949|NCT04753606|141534323|SUPERIORITY||Least Squares (LS) Means|-36.03|STANDARD_ERROR_OF_MEAN|4.488|<|0.0001|TWO_SIDED|95.0|-44.92|-27.14|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-27.14|-44.92|<.0001
70929347|NCT05256654|141355242|SUPERIORITY||Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|7.24||0.854|TWO_SIDED|95.0|-14.6|14.0|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||14.0|-14.6|0.854
70929348|NCT05256654|141355242|SUPERIORITY||Mean Difference (Net)|-16.8|STANDARD_ERROR_OF_MEAN|4.98||0.002|TWO_SIDED|95.0|-26.0|-6.4|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-6.4|-26.0|0.002
71013950|NCT04753606|141534324|SUPERIORITY||Least Squares (LS) Means|129.27|STANDARD_ERROR_OF_MEAN|9.337|<|0.0001|TWO_SIDED|95.0|110.78|147.77|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||147.77|110.78|<.0001
71013951|NCT04753606|141534324|SUPERIORITY||Least Squares (LS) Means|164.33|STANDARD_ERROR_OF_MEAN|9.306|<|0.0001|TWO_SIDED|95.0|145.9|182.76|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||182.76|145.90|<.0001
71013952|NCT04753606|141534325|SUPERIORITY||Least Squares (LS) Means|129.27|STANDARD_ERROR_OF_MEAN|9.337|<|0.0001|TWO_SIDED|95.0|110.78|147.77|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||147.77|110.78|<.0001
71013953|NCT04753606|141534325|SUPERIORITY||Least Squares (LS) Means|164.33|STANDARD_ERROR_OF_MEAN|9.306|<|0.0001|TWO_SIDED|95.0|145.9|182.76|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||182.76|145.90|<.0001
71013954|NCT04753606|141534326|SUPERIORITY||Least Squares (LS) Means|129.27|STANDARD_ERROR_OF_MEAN|9.337|<|0.0001|TWO_SIDED|95.0|110.78|147.77|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||147.77|110.78|<.0001
71013955|NCT04753606|141534326|SUPERIORITY||Least Squares (LS) Means|164.33|STANDARD_ERROR_OF_MEAN|9.306|<|0.0001|TWO_SIDED|95.0|145.9|182.76|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||182.76|145.90|<.0001
71013956|NCT00370994|141534423|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Comparisons were made between groups and within the group between baseline and different time points.|Repeated measures ANOVA.|||||||<0.001
71013957|NCT00370994|141534424|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||There were significant differences in Oswestry Disability Index between both groups|Repeated measures of ANOVA|||||||0.001
71013958|NCT04246593|141534425|OTHER|We used generalized linear mixed model (GLMM) with random intercept to control for clustering within sites. In order to further explore the intervention effect, we fit GLMMs that adjust for (1) baseline dietary intake and (2) race and baseline income.|Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.52||0.84|TWO_SIDED|||||P-value calculated for the mean difference between the user and non-user groups.|GLMM|||||||0.84
71013959|NCT04246593|141534426|OTHER|We used generalized linear mixed model (GLMM) with random intercept to control for clustering within sites.|Median Difference (Net)|-0.59|STANDARD_ERROR_OF_MEAN|1.15||0.61|TWO_SIDED|||||P-value calculated for the mean difference between change in BMI for intervention and control groups.|GLMM|||||||0.61
70850488|NCT02910986|141189167|OTHER||difference between INT and UC|5.0|||||TWO_SIDED|98.3|-4.3|14.3||||||||14.3|-4.3|
70850489|NCT02910986|141189167|OTHER||difference between INT and ENH|2.4|||||TWO_SIDED|98.3|-7.0|11.9||||||||11.9|-7.0|
70929349|NCT05256654|141355242|SUPERIORITY||Mean Difference (Net)|-12.1|STANDARD_ERROR_OF_MEAN|5.28||0.033|TWO_SIDED|95.0|-21.9|-1.1|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-1.1|-21.9|0.033
71013960|NCT04246593|141534427|OTHER|We used generalized linear mixed model (GLMM) with random intercept to control for clustering within sites.|Mean Difference (Net)|-28.02|STANDARD_ERROR_OF_MEAN|43.31||0.53|TWO_SIDED|||||P-value calculated for the mean difference in change scores between the intervention and control groups.|GLMM|||||||0.53
71013961|NCT04246593|141534428|OTHER|We used generalized linear mixed model (GLMM) with random intercept to control for clustering within sites.|Mean Difference (Net)|-0.53|STANDARD_ERROR_OF_MEAN|1.65||0.75|TWO_SIDED|||||The p-value applies to the mean difference in mean self-efficacy change scores between the intervention and control groups.|GLMM|||||||0.75
71013962|NCT04246593|141534429|OTHER|We used generalized linear mixed model (GLMM) with random intercept to control for clustering within sites.|Mean Difference (Net)|-0.56|STANDARD_ERROR_OF_MEAN|1.13||0.63|TWO_SIDED|||||P-value applies to the mean difference in mean total barriers score change between the intervention and control groups.|GLMM|||||||0.63
71013963|NCT01678794|141534452|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|||||||0.26
71013964|NCT01678794|141534453|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
71013965|NCT02260804|141534469|EQUIVALENCE|The equivalence margin of ±17% was predefined.|Difference in proportion|1.8|||||TWO_SIDED|90.0|-6.43|10.2||||||||10.2|-6.43|
71029200|NCT02809183|141565991|OTHER|Two-group test|Difference between group LS means|3.4|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|2.3|4.5||The null hypothesis is the difference between treatment groups (1.5g TRC101 BID - Pooled Placebo) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||4.5|2.3|< 0.0001
71029201|NCT02809183|141565991|OTHER|Two-group test|Difference between group LS means|3.2|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|2.2|4.3||The null hypothesis is the difference between treatment groups (3g TRC101 BID - Pooled Placebo) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||4.3|2.2|< 0.0001
71029202|NCT02809183|141565991|OTHER|Two-group test|Difference between group LS means|3.9|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|2.9|5.0||The null hypothesis is the difference between the treatment groups (4.5g TRC101 BID - Pooled Placebo) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||5.0|2.9|< 0.0001
71029203|NCT02809183|141565992|OTHER|Single-group test|Group LS mean|3.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|3.0|3.7||The null hypothesis is that the mean change from baseline within the Combined TRC101 treatment group = 0 mEq/L.|Mixed Models Analysis|||||3.7|3.0|< 0.0001
71029204|NCT02809183|141565993|OTHER|Two-group test|Difference between group LS means|3.6|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.8|4.4||The null hypothesis is that the difference between treatment groups (Combined TRC101 - Pooled Placebo) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||4.4|2.8|< 0.0001
70929350|NCT05256654|141355243|SUPERIORITY||Mean Difference (Net)|-6.1|STANDARD_ERROR_OF_MEAN|4.03||0.143|TWO_SIDED|95.0|-13.8|2.2|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||2.2|-13.8|0.143
70929351|NCT05256654|141355243|SUPERIORITY||Mean Difference (Net)|-16.4|STANDARD_ERROR_OF_MEAN|2.93|<|0.001|TWO_SIDED|95.0|-22.0|-10.5|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-10.5|-22.0|<.001
71013966|NCT02207413|141534495|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (D-QIV\_LP/ D-QIV\_IP) is ≤ 1.5.|Adjusted GMT Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.11|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for H1N1 strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/ Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.11|0.85|
71013967|NCT02207413|141534495|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/ Influsplit Tetra\_IP) is ≤ 1.5.|Adjusted GMT Ratio|1.05|||||TWO_SIDED|95.0|0.94|1.18|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for H3N2 strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.18|0.94|
71013968|NCT02207413|141534495|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/ Influsplit Tetra\_IP) is ≤ 1.5|Adjusted GMT Ratio|1.03|||||TWO_SIDED|95.0|0.91|1.16|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for Yamagata strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.16|0.91|
71013969|NCT02207413|141534495|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/ Influsplit Tetra\_IP) is ≤ 1.5.|Adjusted GMT Ratio|1.04|||||TWO_SIDED|95.0|0.9|1.21|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for Victoria strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.21|0.90|
71013970|NCT02207413|141534496|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/Influsplit Tetra\_IP) is ≤ 1.5.|Adjusted GMT ratio|1.07|||||TWO_SIDED|95.0|0.9|1.28|||ANCOVA|||The adjusted GMT of HI antibodies for H1N1 strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.28|0.90|
71013971|NCT02207413|141534496|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/Influsplit Tetra\_IP) is ≤ 1.5|Adjusted GMT Ratio|1.18|||||TWO_SIDED|95.0|1.0|1.39|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for H3N2 strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.39|1.00|
71013972|NCT02207413|141534496|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/Influsplit Tetra\_IP) is ≤ 1.5.|Adjusted GMT Ratio|1.07|||||TWO_SIDED|95.0|0.91|1.27|||ANCOVA|||The adjusted GMT of HI antibodies for Yamagata strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.27|0.91|
71013973|NCT02207413|141534496|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/Influsplit Tetra\_IP) is ≤ 1.5.|Adjusted GMT Ratio|1.17|||||TWO_SIDED|95.0|0.99|1.38|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for Victoria strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate||1.38|0.99|
71013974|NCT00066573|141534526|SUPERIORITY|To detect a hazard ratio (HR) of 0.80 between exemestane and anastrozole (ie, an improvement in 5-year EFS from 87.5% to 89.9%, with a two-sided 5% level test and 80% power, 6,840 patients and 630 events were needed for final analysis.|Hazard Ratio (HR)|1.02||||0.85|TWO_SIDED|95.0|0.87|1.18|||Log Rank|||||1.18|0.87|0.85
70929352|NCT05256654|141355243|SUPERIORITY||Mean Difference (Net)|-22.7|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED|95.0|-27.9|-17.2|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-17.2|-27.9|<.001
71013975|NCT00066573|141534527|SUPERIORITY|No power calculation for secondary analysis|Hazard Ratio (HR)|0.93||||0.46|TWO_SIDED|95.0|0.77|1.13|||Log Rank|||||1.13|0.77|0.46
71013976|NCT01241591|141534530|NON_INFERIORITY_OR_EQUIVALENCE|The a priori threshold for non-inferiority was -15% and a step-down approach was used to adjust for multiple comparisons. Non-inferiority of CP-690,550 5 mg to etanercept was concluded if the 95% lower confidence intervals (LCIs) of the difference for PGA and Psoriasis Area and Severity Index 75 (PASI75) responses at Week 12 were greater than -15%, and CP-690,550 10 mg was superior to placebo for PGA response and PASI75 at Week 12.|Mean Difference|-19.16|STANDARD_ERROR_OF_MEAN|3.77|||TWO_SIDED|95.0|-26.55|-11.76||||||Difference from Etanercept (Active-Etanercept)||-11.76|-26.55|
71013977|NCT01241591|141534530|SUPERIORITY_OR_OTHER||Mean Difference|32.16|STANDARD_ERROR_OF_MEAN|4.41|||TWO_SIDED|95.0|23.51|40.81||||||Difference from Placebo (Active-Placebo); the a priori threshold for superiority was 0 and a step-down approach was used to adjust for multiple comparisons. Superiority of CP-690,550 5 mg to placebo was concluded if the lower bounds of the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than 0, and non-inferiority of CP-690,550 5 mg was concluded to be non-inferior to etanercept.||40.81|23.51|
71013978|NCT01241591|141534530|NON_INFERIORITY_OR_EQUIVALENCE|The a priori threshold for non-inferiority was -15% and a step-down approach was used to adjust for multiple comparisons. Non-inferiority of CP-690,550 10 mg to etanercept was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than -15%.|Mean Difference|1.91|STANDARD_ERROR_OF_MEAN|3.64|||TWO_SIDED|95.0|-5.22|9.05||||||Difference from Etanercept (Active-Etanercept)||9.05|-5.22|
71013979|NCT01241591|141534530|SUPERIORITY_OR_OTHER||Mean Difference|53.23|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|44.81|61.65||||||Difference from Placebo (Active-Placebo); the a priori threshold for superiority was 0 and a step-down approach was used to adjust for multiple comparisons. Superiority of CP-690,550 10 mg to placebo was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than 0, and non-inferiority of CP-690,550 10 mg was concluded to be non-inferior to etanercept.||61.65|44.81|
71013980|NCT01241591|141534531|NON_INFERIORITY_OR_EQUIVALENCE|The a priori threshold for non-inferiority was -15% and a step-down approach was used to adjust for multiple comparisons. Non-inferiority of CP-690,550 5 mg to etanercept was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than -15%, and CP-690,550 10 mg was superior to placebo for PGA and PASI75 response at Week 12.|Mean Difference|-19.29|STANDARD_ERROR_OF_MEAN|3.81|||TWO_SIDED|95.0|-26.75|-11.83||||||Difference from Etanercept (Active-Etanercept)||-11.83|-26.75|
71013981|NCT01241591|141534531|SUPERIORITY_OR_OTHER||Mean Difference|33.91|STANDARD_ERROR_OF_MEAN|3.49|||TWO_SIDED|95.0|27.06|40.76||||||Difference from Placebo (Active-Placebo); the a priori threshold for superiority was 0 and a step-down approach was used to adjust for multiple comparisons. Superiority of CP-690,550 5 mg to placebo was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than 0, and non-inferiority of CP-690,550 5 mg was concluded to be non-inferior to etanercept.||40.76|27.06|
71013982|NCT01241591|141534531|NON_INFERIORITY_OR_EQUIVALENCE|The a priori threshold for non-inferiority was -15% and a step-down approach was used to adjust for multiple comparisons. Non-inferiority of CP-690,550 10 mg to etanercept was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than -15%.|Mean Difference|4.83|STANDARD_ERROR_OF_MEAN|3.77|||TWO_SIDED|95.0|-2.57|12.23||||||Difference from Etanercept (Active-Etanercept)||12.23|-2.57|
71013983|NCT01241591|141534531|SUPERIORITY_OR_OTHER||Mean Difference|58.03|STANDARD_ERROR_OF_MEAN|3.46|||TWO_SIDED|95.0|51.25|64.81||||||Difference from Placebo (Active-Placebo); the a priori threshold for superiority was 0 and a step-down approach was used to adjust for multiple comparisons. Superiority of CP-690,550 10 mg to placebo was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than 0, and non-inferiority of CP-690,550 10 mg was concluded to be non-inferior to etanercept.||64.81|51.25|
71013984|NCT01798056|141534579|NON_INFERIORITY|Criteria used: The lower limit (LL) of the 95% confidence interval (CI) of the Geometric Mean (GM) ratio (GSK1437173A PreChemo group over Placebo PreChemo group) in anti-gE ELISA antibody concentrations is greater than 3.|Adjusted GMC ratio|23.2|||||TWO_SIDED|95.0|17.9|30.0||||Difference of means between vaccines and placebo were calculated together with 2-sided confidence intervals and back-transformed to the original units||The analysis evaluated the anti-gE humoral immune responses at Month 2, following a two-dose administration of the GSK1437173A vaccine, as compared to placebo in subjects with solid tumours receiving chemotherapy (PreChemo Groups only).||30|17.9|
71029205|NCT02809183|141565994|OTHER|Two-group test|||||<|0.0001||||||The null hypothesis is that the difference between treatment groups (1.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 2 mEq/L = 0.|Fisher Exact|||||||< 0.0001
71029206|NCT02809183|141565994|OTHER|Two-group test|||||<|0.0001||||||The null hypothesis is that the difference between treatment groups (1.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 3 mEq/L = 0.|Fisher Exact|||||||< 0.0001
70850490|NCT01727024|141189170|SUPERIORITY_OR_OTHER|||||||0.451|||||||Generalized Estimating Equation (GEE)|||||||0.451
70929353|NCT05256654|141355244|SUPERIORITY||Mean Difference (Net)|-10.8|STANDARD_ERROR_OF_MEAN|5.55||0.068|TWO_SIDED|95.0|-21.1|0.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||0.9|-21.1|0.068
71013985|NCT02646566|141534633|SUPERIORITY|||||||0.003||||||One-sided p-value. After adjustment for multiplicity using Hommel's method. (Note: unadjusted p value = 0.003) A priori threshold for statistical significance = 0.025.|Chi-squared|||The primary efficacy analysis was a comparison of the incidence of the primary efficacy variable between the two groups that received APD421 and the group that received placebo, using Pearson's χ2 test. The threshold for determining statistical significance in the comparison of incidence of success between the active and placebo groups (the primary efficacy analysis) was a p-value of 2.5% one-sided.||||0.003
71013986|NCT02646566|141534633|SUPERIORITY|||||||0.109||||||One-sided p-value. After adjustment for multiplicity using Hommel's method. (Note: unadjusted p value = 0.109) A priori threshold for statistical significance = 0.025.|Chi-squared|||The primary efficacy analysis was a comparison of the incidence of the primary efficacy variable between the two groups that received APD421 and the group that received placebo, using Pearson's χ2 test. The threshold for determining statistical significance in the comparison of incidence of success between the active and placebo groups (the primary efficacy analysis) was a p-value of 2.5% one-sided.||||0.109
70929354|NCT05256654|141355244|SUPERIORITY||Mean Difference (Net)|-25.5|STANDARD_ERROR_OF_MEAN|3.79|<|0.001|TWO_SIDED|95.0|-32.6|-17.6|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-17.6|-32.6|<.001
70929355|NCT05256654|141355244|SUPERIORITY||Mean Difference (Net)|-23.8|STANDARD_ERROR_OF_MEAN|3.88|<|0.001|TWO_SIDED|95.0|-31.1|-15.7|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-15.7|-31.1|<.001
71013987|NCT02646566|141534634|SUPERIORITY||||||<|0.001||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||<0.001
71013988|NCT02646566|141534634|SUPERIORITY|||||||0.059||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.059
71013989|NCT02646566|141534635|SUPERIORITY||||||<|0.001||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||<0.001
71013990|NCT02646566|141534635|SUPERIORITY|||||||0.053||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.053
71013991|NCT02646566|141534636|SUPERIORITY||||||<|0.001||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||<0.001
71013992|NCT02646566|141534636|SUPERIORITY|||||||0.021||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.021
71013993|NCT02646566|141534637|SUPERIORITY||||||<|0.001|||||||Regression, Cox|||||||<0.001
71013994|NCT02646566|141534637|SUPERIORITY|||||||0.084|||||||Regression, Cox|||||||0.084
71013995|NCT02646566|141534638|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71013996|NCT02646566|141534638|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
71013997|NCT02646566|141534639|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71013998|NCT02646566|141534639|SUPERIORITY|||||||0.179|||||||Chi-squared|||||||0.179
71013999|NCT02646566|141534640|SUPERIORITY|||||||0.009|||||||Chi-squared|||||||0.009
71014000|NCT02646566|141534640|SUPERIORITY|||||||0.315|||||||Chi-squared|||||||0.315
71014001|NCT02646566|141534641|SUPERIORITY|||||||0.065|||||||Chi-squared|||||||0.065
71014002|NCT02646566|141534641|SUPERIORITY|||||||0.52|||||||Chi-squared|||||||0.520
71014003|NCT02646566|141534642|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
71014004|NCT02646566|141534642|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.420
71014005|NCT02646566|141534643|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71014006|NCT02646566|141534643|SUPERIORITY|||||||0.258|||||||Wilcoxon (Mann-Whitney)|||||||0.258
71014007|NCT02222246|141534650|NON_INFERIORITY|Change in pain scores from arrival to discharge||||||0.0311|||||||Mixed Models Analysis|Analysis for pain change was conducted using Hierarchical Linear Mixed Effects Model (HLM), adjusting for nested patient and site effects (N=126)||||||0.0311
71014008|NCT02222246|141534651|NON_INFERIORITY|Trajectory of pain across time (arrival to discharge)||||||0.0049||||||p-value for the protocol by time interaction|Mixed Models Analysis|||The trajectory of change in pain score was evaluated every 30 minutes over 120 hours (2 hours) rather than 6 hours because of expected missing data after 120 minutes due to discharge from the ED.||||0.0049
71014009|NCT02222246|141534651|NON_INFERIORITY|Emergency Department Arrival||||||0.9393|||||||t-test, 2 sided|||||||0.9393
71014010|NCT02222246|141534651|NON_INFERIORITY|Post-placement 30 minutes||||||0.7259|||||||t-test, 2 sided|||||||0.7259
71014011|NCT02222246|141534651|NON_INFERIORITY|Post-placement 60 minutes||||||0.53|||||||t-test, 2 sided|||||||0.5300
71014012|NCT02222246|141534651|NON_INFERIORITY|Post-placement 90 minutes||||||0.3678|||||||t-test, 2 sided|||||||0.3678
71014013|NCT02222246|141534651|NON_INFERIORITY|Post-placement 120 minutes||||||0.2457|||||||t-test, 2 sided|||||||0.2457
71014014|NCT02222246|141534651|NON_INFERIORITY|Emergency Department Discharge||||||0.0007|||||||t-test, 2 sided|||||||0.0007
71014015|NCT02222246|141534652|NON_INFERIORITY|Incidence of nausea during Emergency Department Visit - YES||||||0.0001|||||||Chi-squared|||||||0.0001
71014016|NCT02222246|141534653|NON_INFERIORITY|Incidence of vomiting (YES) during Emergency Department visit||||||0.6625|||||||Chi-squared|||||||0.6625
71014017|NCT02222246|141534654|NON_INFERIORITY|Decrease in systolic BP (\>= 20% of baseline)||||||0.4473|||||||Chi-squared|||||||0.4473
71014018|NCT02222246|141534655|NON_INFERIORITY|Decrease in diastolic blood pressure (\>= 20% baseline)||||||0.5372|||||||Chi-squared|||||||0.5372
71014019|NCT02222246|141534656|NON_INFERIORITY|Incidence of oxygen desaturation (\<95%) YES during Emergency Department visit||||||0.2891|||||||Chi-squared|||||||0.2891
71014020|NCT02222246|141534658|NON_INFERIORITY|Incidence of sedation during Emergency Department visit.||||||0.3915|||||||Chi-squared|||||||0.3915
71048405|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.06|||||TWO_SIDED|95.0|-0.18|0.06|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B||0.06|-0.18|
71048406|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.02|||||TWO_SIDED|95.0|-0.13|0.09|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V||0.09|-0.13|
71048407|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.04|||||TWO_SIDED|95.0|-0.15|0.07|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V||0.07|-0.15|
71048408|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.02|||||TWO_SIDED|95.0|-0.13|0.09|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V||0.09|-0.13|
70941530|NCT00733226|141383812|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.11|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-2.94|-1.27|||Wilcoxon (Mann-Whitney)|P value was not need to adjusted for multiple comparisons||||-1.27|-2.94|<0.001
71014021|NCT02222246|141534659|NON_INFERIORITY|Incidence of the need for supplemental oxygen during Emergency Department visit||||||0.0726|||||||Chi-squared|||||||0.0726
71014022|NCT04621227|141534663|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Adjusted Geometric Mean Ratio (%)|202.94|||||TWO_SIDED|90.0|167.14|246.41|||Mixed Models Analysis|||Comparison for AUClast (PF-06882961 120mg BID + rosuvastatin 10mg \[Period 4\] vs Rosuvastatin 10mg \[Period 1\])||246.41|167.14|
71014023|NCT04621227|141534663|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Adjusted Geometric Mean Ratio (%)|283.73|||||TWO_SIDED|90.0|233.68|344.51|||Mixed Models Analysis|||Comparison for AUClast (PF-06882961 200mg BID + rosuvastatin 10mg \[Period 7\] vs Rosuvastatin 10mg \[Period 1\])||344.51|233.68|
71014024|NCT04621227|141534664|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Adjusted Geometric Mean Ratio (%)|50.57|||||TWO_SIDED|90.0|42.27|60.5|||Mixed Models Analysis|||Comparison for AUClast (PF-06882961 120mg BID + midazolam 2mg \[Period 5\] vs Midazolam 2mg \[Period 2\])||60.50|42.27|
71014025|NCT04621227|141534664|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Adjusted Geometric Mean Ratio (%)|50.56|||||TWO_SIDED|90.0|42.06|60.78|||Mixed Models Analysis|||Comparison for AUClast (PF-06882961 200mg BID + midazolam 2mg \[Period 8\] vs Midazolam 2mg \[Period 2\])||60.78|42.06|
71014026|NCT01366846|141534682|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Comparison of the percentage of subjects with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Avoidance After Peanut Consumption Group within the SPT-negative stratum.||||<0.001
71014027|NCT01366846|141534682|SUPERIORITY_OR_OTHER|||||||0.004|||||||Chi-squared|||Comparison of the percentage of subjects with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Avoidance After Peanut Consumption Group within the SPT-positive stratum.||||0.004
71014028|NCT01366846|141534683|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Comparison of the percentage of participants with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Consumption Group across both the SPT-negative and SPT-positive strata.||||<0.001
71014029|NCT01366846|141534684|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Comparison of the percentage of subjects with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Avoidance After Peanut Consumption Group within the SPT-negative stratum.||||<0.001
71014030|NCT01366846|141534684|SUPERIORITY_OR_OTHER|||||||0.027|||||||Chi-squared|||Comparison of the percentage of subjects with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Avoidance After Peanut Consumption Group within the SPT-positive stratum.||||0.027
71014031|NCT01366846|141534685|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Comparison of the percentage of subjects with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Avoidance After Peanut Consumption Group across both the SPT-negative and SPT-positive strata.||||<0.001
71014032|NCT01366846|141534686|SUPERIORITY_OR_OTHER|||||||0.25|||||||Exact McNemar|||Comparison of the percentage of subjects with peanut allergy in the Peanut Avoidance After Peanut Consumption Group at month 60 to that of the Peanut Avoidance After Peanut Consumption Group at month 72 across both the SPT-negative and SPT-positive strata.||||0.250
71014033|NCT01366846|141534687|SUPERIORITY_OR_OTHER|||||||0.25|||||||Exact McNemar|||Comparison of the percentage of subjects with peanut allergy in the Peanut Avoidance After Peanut Consumption Group at month 60 to that of the Peanut Avoidance After Peanut Consumption Group at month 72 across both the SPT-negative and SPT-positive strata.||||0.250
71014034|NCT01342445|141534689|SUPERIORITY_OR_OTHER_LEGACY||Partial eta squared|0.34|||<|0.001||||||we adjusted p values to control for the false discovery rate using procedures described by Benjamini and Hochberg (1995). Thus, an alpha value of .021 was used as significance threshold.|ANOVA|"F(4, 84) = 10.9~This was a one-way ANOVA with repeated measures across dosage conditions (no drug baseline, placebo, 30-mg, 50-mg, 70-mg LDX)."||This was a within-subject crossover design with all participants going through a no-drug baseline followed by placebo and three dosages of LDX, with the latter four conditions in a randomly assigned, counterbalanced order. The comparison condition was the placebo condition.||||<0.001
71014035|NCT01342445|141534690|SUPERIORITY_OR_OTHER_LEGACY||partial eta squared|0.28|||<|0.001||||||we adjusted p values to control for the false discovery rate using procedures described by Benjamini and Hochberg (1995). Thus, an alpha value of .021 was used as significance threshold.|ANOVA|"F(4, 84) = 8.14~This was a one-way ANOVA with repeated measures across dosage conditions (no drug baseline, placebo, 30-mg, 50-mg, 70-mg LDX)."||This was a within-subject crossover design with all participants going through a no-drug baseline followed by placebo and three dosages of LDX, with the latter four conditions in a randomly assigned, counterbalanced order. The comparison condition was the placebo condition.||||<.001
71048409|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.06|||||TWO_SIDED|95.0|-0.19|0.06|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14||0.06|-0.19|
70929356|NCT05256654|141355245|SUPERIORITY||Mean Difference (Net)|-36.3|STANDARD_ERROR_OF_MEAN|5.21|<|0.001|TWO_SIDED|95.0|-45.8|-25.1|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-25.1|-45.8|<.001
70929357|NCT05256654|141355245|SUPERIORITY||Mean Difference (Net)|-50.3|STANDARD_ERROR_OF_MEAN|3.31|<|0.001|TWO_SIDED|95.0|-56.4|-43.3|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-43.3|-56.4|<.001
71048410|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.04|||||TWO_SIDED|95.0|-0.17|0.08|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14||0.08|-0.17|
71048411|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.02|||||TWO_SIDED|95.0|-0.11|0.15|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14||0.15|-0.11|
71048412|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.12|||||TWO_SIDED|95.0|-0.25|0.0|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C||0.00|-0.25|
71048413|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.24|||||TWO_SIDED|95.0|-0.37|-0.12|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C||-0.12|-0.37|
71048414|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.12|||||TWO_SIDED|95.0|-0.25|0.01|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C||0.01|-0.25|
71048415|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.03|||||TWO_SIDED|95.0|-0.18|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F||0.11|-0.18|
71048416|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.37|||||TWO_SIDED|95.0|-0.51|-0.22|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F||-0.22|-0.51|
71048417|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.33|||||TWO_SIDED|95.0|-0.47|-0.2|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F||-0.20|-0.47|
71048418|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.03|||||TWO_SIDED|95.0|-0.17|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F||0.11|-0.17|
71048419|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.08|||||TWO_SIDED|95.0|-0.07|0.22|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F||0.22|-0.07|
71048420|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.11|||||TWO_SIDED|95.0|-0.03|0.25|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F||0.25|-0.03|
71048421|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.07|||||TWO_SIDED|95.0|-0.2|0.06|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1||0.06|-0.20|
71048422|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.09|||||TWO_SIDED|95.0|-0.21|0.03|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1||0.03|-0.21|
71048423|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.02|||||TWO_SIDED|95.0|-0.15|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1||0.11|-0.15|
71048424|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.06|||||TWO_SIDED|95.0|-0.06|0.18|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3||0.18|-0.06|
71048425|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.07|||||TWO_SIDED|95.0|-0.18|0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3||0.04|-0.18|
71048426|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.13|||||TWO_SIDED|95.0|-0.25|-0.01|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3||-0.01|-0.25|
71048427|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.17|||||TWO_SIDED|95.0|0.05|0.28|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5||0.28|0.05|
71048428|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.1|||||TWO_SIDED|95.0|0.0|0.21|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5||0.21|-0.00|
71048429|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.06|||||TWO_SIDED|95.0|-0.17|0.05|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5||0.05|-0.17|
70929358|NCT05256654|141355245|SUPERIORITY||Mean Difference (Net)|-52.5|STANDARD_ERROR_OF_MEAN|3.17|<|0.001|TWO_SIDED|95.0|-58.4|-45.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-45.9|-58.4|<.001
70929359|NCT05256654|141355246|SUPERIORITY||Mean Difference (Net)|-38.6|STANDARD_ERROR_OF_MEAN|7.76|<|0.001|TWO_SIDED|95.0|-52.2|-21.2|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-21.2|-52.2|<.001
71048430|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.08|||||TWO_SIDED|95.0|-0.04|0.19|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A||0.19|-0.04|
71048431|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.1|||||TWO_SIDED|95.0|-0.02|0.21|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A||0.21|-0.02|
71048432|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.02|||||TWO_SIDED|95.0|-0.1|0.14|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A||0.14|-0.10|
71048433|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.03|||||TWO_SIDED|95.0|-0.1|0.15|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F||0.15|-0.10|
71048434|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.05|||||TWO_SIDED|95.0|-0.17|0.07|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F||0.07|-0.17|
71048435|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.08|||||TWO_SIDED|95.0|-0.2|0.05|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F||0.05|-0.20|
70929360|NCT05256654|141355246|SUPERIORITY||Mean Difference (Net)|-54.0|STANDARD_ERROR_OF_MEAN|4.69|<|0.001|TWO_SIDED|95.0|-62.4|-43.8|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-43.8|-62.4|<.001
70929361|NCT05256654|141355246|SUPERIORITY||Mean Difference (Net)|-63.6|STANDARD_ERROR_OF_MEAN|3.72|<|0.001|TWO_SIDED|95.0|-70.3|55.5|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||55.5|-70.3|<.001
70929362|NCT05256654|141355247|SUPERIORITY||Mean Difference (Net)|-4.1|STANDARD_ERROR_OF_MEAN|5.99||0.506|TWO_SIDED|95.0|-15.2|8.5|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||8.5|-15.2|0.506
71048436|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.01|||||TWO_SIDED|95.0|-0.11|0.13|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A||0.13|-0.11|
71048437|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.02|||||TWO_SIDED|95.0|-0.14|0.1|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A||0.10|-0.14|
71048438|NCT00444457|141605463|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.03|||||TWO_SIDED|95.0|-0.15|0.08|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A||0.08|-0.15|
71048439|NCT02227147|141605481|SUPERIORITY||Difference in percentage|40.4|||=|0.006|TWO_SIDED|90.0|14.2|66.6|||Chi-squared|||||66.6|14.2|=0.006
71048440|NCT02227147|141605482|SUPERIORITY||Difference in percentage|36.1|||=|0.013|TWO_SIDED|95.0|9.4|62.7|||Chi-squared|||||62.7|9.4|=0.013
71048441|NCT02227147|141605483|SUPERIORITY||difference in percentage|19.0|||=|0.191|TWO_SIDED|95.0|-9.0|47.1|||Chi-squared|||week 4 - central reviewer||47.1|-9.0|=0.191
71048442|NCT02227147|141605483|SUPERIORITY||difference in percentage|10.7|||=|0.464|TWO_SIDED|95.0|-17.7|39.1|||Chi-squared|||week 6 - central reviewer||39.1|-17.7|=0.464
71048443|NCT02227147|141605483|SUPERIORITY||difference in percentage|14.9|||=|0.308|TWO_SIDED|95.0|-13.4|43.1|||Chi-squared|||week 4 - investigator||43.1|-13.4|=0.308
71048444|NCT02227147|141605483|SUPERIORITY||difference in percentage|23.6|||=|0.106|TWO_SIDED|95.0|-4.2|51.3|||Chi-squared|||week 6 - investigator||51.3|-4.2|=0.106
71048445|NCT02227147|141605484|SUPERIORITY||difference in percentage|9.5|||=|0.255|TWO_SIDED|95.0|-6.9|25.9|||Chi-squared|||week 4||25.9|-6.9|=0.255
71048446|NCT02227147|141605484|SUPERIORITY||difference in percentage|0.8|||=|0.927|TWO_SIDED|95.0|-15.6|17.1|||Chi-squared|||week 6||17.1|-15.6|=0.927
71048447|NCT02227147|141605484|SUPERIORITY||difference in percentage|18.6|||=|0.062|TWO_SIDED|95.0|-0.7|37.8|||Chi-squared|||week 8||37.8|-0.7|=0.062
71048448|NCT02227147|141605485|SUPERIORITY||difference in least square means|1.1|||=|0.745|TWO_SIDED|95.0|-5.6|7.7|||ANCOVA|||||7.7|-5.6|=0.745
71048449|NCT02227147|141605486|SUPERIORITY||difference in percentage|-3.8|||=|0.672|TWO_SIDED|95.0|-21.3|13.7|||Chi-squared|||week 4||13.7|-21.3|=0.672
70941531|NCT00733226|141383813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.22||0.11|TWO_SIDED|95.0|-0.77|0.11||P value was not need to adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||0.11|-0.77|0.110
70929363|NCT05256654|141355247|SUPERIORITY||Mean Difference (Net)|-19.7|STANDARD_ERROR_OF_MEAN|4.04|<|0.001|TWO_SIDED|95.0|-27.2|-11.3|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-11.3|-27.2|<.001
70929364|NCT05256654|141355247|SUPERIORITY||Mean Difference (Net)|-19.4|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-27.0|-11.0|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-11.0|-27.0|<.001
71048450|NCT02227147|141605486|SUPERIORITY||difference in percentage|0.5|||=|0.955|TWO_SIDED|95.0|-18.5|19.6|||Chi-squared|||week 6||19.6|-18.5|=0.955
71048451|NCT02227147|141605486|SUPERIORITY||difference in percentage|-3.6|||=|0.727|TWO_SIDED|95.0|-23.9|16.7|||Chi-squared|||week 8||16.7|-23.9|=0.727
71048452|NCT02227147|141605487|SUPERIORITY||least square mean difference|0.6|||=|0.207|TWO_SIDED|95.0|-0.4|1.5|||ANCOVA|||||1.5|-0.4|=0.207
71048453|NCT02227147|141605488|SUPERIORITY||difference in percentage|-13.3|||=|0.11|TWO_SIDED|95.0|-30.5|3.9|||Chi-squared|||||3.9|-30.5|=0.110
70929365|NCT05256654|141355248|SUPERIORITY||Mean Difference (Net)|-3.4|STANDARD_ERROR_OF_MEAN|4.16||0.428|TWO_SIDED|95.0|-11.2|5.2|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||5.2|-11.2|0.428
71048454|NCT03709823|141605520|SUPERIORITY||LS Mean Difference vs. Placebo|-20.48||||0.0002|TWO_SIDED|95.0|-31.141|-9.821||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||-9.821|-31.141|0.0002
70929366|NCT05256654|141355248|SUPERIORITY||Mean Difference (Net)|-8.7|STANDARD_ERROR_OF_MEAN|3.14||0.009|TWO_SIDED|95.0|-14.7|-2.3|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-2.3|-14.7|0.009
70929367|NCT05256654|141355248|SUPERIORITY||Mean Difference (Net)|-12.2|STANDARD_ERROR_OF_MEAN|3.04|<|0.001|TWO_SIDED|95.0|-18.0|-6.0|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-6.0|-18.0|<.001
70929368|NCT05256654|141355249|SUPERIORITY||Mean Difference (Net)|6.5|STANDARD_ERROR_OF_MEAN|8.1||0.412|TWO_SIDED|95.0|-8.4|23.7|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||23.7|-8.4|0.412
70929369|NCT05256654|141355249|SUPERIORITY||Mean Difference (Net)|-9.5|STANDARD_ERROR_OF_MEAN|5.52||0.104|TWO_SIDED|95.0|-19.7|2.1|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||2.1|-19.7|0.104
70929370|NCT05256654|141355249|SUPERIORITY||Mean Difference (Net)|-5.4|STANDARD_ERROR_OF_MEAN|5.79||0.363|TWO_SIDED|95.0|-16.2|6.7|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||6.7|-16.2|0.363
71048455|NCT03709823|141605520|SUPERIORITY||LS Mean Difference vs. Placebo|-22.07|||<|0.0001|TWO_SIDED|95.0|-32.791|-11.342||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||-11.342|-32.791|< 0.0001
71048456|NCT03709823|141605520|SUPERIORITY||LS Mean Difference vs. Placebo|-5.9||||0.2708|TWO_SIDED|95.0|-16.463|4.66||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||4.660|-16.463|0.2708
71048457|NCT03709823|141605520|SUPERIORITY||LS Mean Difference vs. Placebo|-2.81||||0.6018|TWO_SIDED|95.0|-13.438|7.82||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||7.820|-13.438|0.6018
71048458|NCT03709823|141605520|SUPERIORITY||LS Mean Difference vs. Commercial Sched.|-12.17||||0.1025|TWO_SIDED|95.0|-26.869|2.535||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||2.535|-26.869|0.1025
71048459|NCT03709823|141605521|SUPERIORITY||LS Mean Difference vs. Placebo|-14.61||||0.001|TWO_SIDED|95.0|-23.216|-6.009||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||-6.009|-23.216|0.0010
71048460|NCT03709823|141605521|SUPERIORITY||LS Mean Difference vs. Placebo|-16.2||||0.0003|TWO_SIDED|95.0|-24.862|-7.548||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||-7.548|-24.862|0.0003
71048461|NCT03709823|141605522|SUPERIORITY||LS Mean Difference vs. Placebo|-12.41||||0.0091|TWO_SIDED|95.0|-21.695|-3.135||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||-3.135|-21.695|0.0091
71048462|NCT03709823|141605522|SUPERIORITY||LS Mean Difference vs. Placebo|-9.3||||0.0518|TWO_SIDED|95.0|-18.667|0.075||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||0.075|-18.667|0.0518
71077875|NCT02913105|141664398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.0771|TWO_SIDED|90.0|0.92|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 7||1.00|0.92|0.0771
71048463|NCT01055132|141605523|NON_INFERIORITY_OR_EQUIVALENCE|Based on historical data, a minimum of 42 subjects is needed to achieve 80% power with 0.05 type I error.|Least-square mean difference|-0.037|STANDARD_ERROR_OF_MEAN|0.0072|||TWO_SIDED|95.0|-0.041|-0.0013|||linear mixed model|Sequence of wear, period and lens were included as fixed effects; site, patient, eye\*patient, period\*patient and period\*eye\*patient as random effects.|Comparison between study lenses was carried out using 2-sided 95% confidence interval of the least-square mean difference(test minus control). The non-inferiority was concluded if the upper limit of the confidence limit is below 0.05 LogMAR.|Ho:The test lens is non-inferior to the active comparator lens for monocular visual performance on logMAR scale at 1-week follow-up. A non-inferiority margin of 0.05 logMAR was used.||-0.0013|-0.041|
71048464|NCT01055132|141605524|NON_INFERIORITY_OR_EQUIVALENCE|Based on historical data, a minimum of 42 subjects is needed to achieve a minimum of 80% power with 0.05 type I error.|Least-square mean difference|-0.015|STANDARD_ERROR_OF_MEAN|0.0062|||TWO_SIDED|95.0|-0.027|-0.003|||linear mixed model|Sequence of wear,lens period and lens were included in the model as fixed effects; site, patient, period\*patient were included as random effects.|Comparison between study lenses was carried out using 2-sided 95% confidence interval of the least-square mean difference (test minus control). The non-inferiority was concluded if the upper limit of the confidence limit is below 0.05 LogMAR.|Ho:The test lens is non-inferior to the active comparator lens for Binocular visual performance on logMAR scale at 1-week follow-up. A non-inferiority margin of 0.05 logMAR was used.||-0.003|-0.027|
70850491|NCT00329797|141189179|SUPERIORITY|||||||0.95|||||||Log Rank|||The study is designed to show a 40% relative reduction in the yearly ABF hazard rate, equivalent to an improvement in a 3-year FABF rate from 88% to 92.6%. A sample size of 1030 analyzable patients with a one-sided log-rank test at α = 0.05, was calculated to provide 80% statistical power, with one interim analysis and a final analysis for efficacy using Haybittle-Peto boundaries.||||0.95
71048465|NCT01055132|141605525|NON_INFERIORITY_OR_EQUIVALENCE|Based on historical data, a minimum of 42 subjects is needed to achieve a minimum of 80% power with 0.05 type I error.|Least-square mean difference|11.9|STANDARD_ERROR_OF_MEAN|3.93|||TWO_SIDED|95.0|4.05|19.79|||linear mixed model|Sequence of lens wear, lens period and lens type were included in the model as fixed effects; and Site and patient as random effects.|Comparison between study lenses was carried out using 2-sided 95% confidence interval of the least-square mean difference (test minus control). The non-inferiority was concluded if the lower limit of the confidence interval is higher than -5.|Ho:The test lens is non-inferior to the active comparator lens for comfort at 1-week follow-up. A non-inferiority margin of -5 units was used.||19.79|4.05|
71048466|NCT01055132|141605526|NON_INFERIORITY_OR_EQUIVALENCE|Based on historical data, a minimum of 42 subjects is needed to achieve a minimum of 80% power with 0.05 type I error.|least-square mean difference|7.7|STANDARD_ERROR_OF_MEAN|3.55|||TWO_SIDED|95.0|0.58|14.8|||linear mixed model|Sequence of lens wear, lens period and lens type were included in the model as fixed effects; and site and patient as random effects.|Comparison between study lenses was carried out using 2-sided 95% confidence interval of the least-square mean difference (test minus control). The non-inferiority was concluded if the lower limit of the confidence interval is higher than -5.|Ho:The test lens is non-inferior to the active comparator lens for overall quality of vision at 1-week follow-up. A non-inferiority margin of -5 units was used.||14.80|0.58|
71048467|NCT00158600|141605528|SUPERIORITY_OR_OTHER||Difference|28.12||||0.0347||95.0|2.07|54.17||The threshold for determining statistical significance is 0.05. A fixed testing sequence procedure was used to preserve an overall error rate of 5% for the co-primary efficacy endpoints by linking the test of FVC to the result of 6MWT.|ANCOVA|||The difference between alglucosidase alfa and placebo treatment groups in change in distance walked from baseline to last observation was estimated by ANCOVA after adjusting for baseline value and randomization strata.||54.17|2.07|0.0347
71048468|NCT00158600|141605529|SUPERIORITY_OR_OTHER||Difference|3.4||||0.0055||95.0|1.03|5.77||The threshold for determining statistical significance is 0.05. A fixed testing sequence procedure was used to preserve an overall error rate of 5% for the co-primary efficacy endpoints by linking the test of FVC to the result of 6MWT.|ANCOVA|||The difference between alglucosidase alfa and placebo treatment groups in change in % predicted FVC from baseline to last observation was estimated by ANCOVA after adjusting for baseline value and randomization strata.||5.77|1.03|0.0055
71048469|NCT00158600|141605530|SUPERIORITY_OR_OTHER||Difference|3.18||||0.1093||95.0|-0.73|7.08||The threshold for determining statistical significance is 0.05. No adjustment for multiple comparison was made for secondary efficacy endpoints.|ANCOVA|||The difference between alglucosidase alfa and placebo treatment groups in change in QMT from baseline to last observation was estimated by ANCOVA after adjusting for baseline value and randomization strata.||7.08|-0.73|0.1093
71048470|NCT00158600|141605531|SUPERIORITY_OR_OTHER||Difference|-0.37||||0.8333||95.0|-3.83|3.09||The threshold for determining statistical significance is 0.05. No adjustment for multiple comparison was made for secondary efficacy endpoints.|ANCOVA|||The difference between alglucosidase alfa and placebo treatment groups in change in PCS from baseline to last observation was estimated by ANCOVA after adjusting for baseline value and randomization strata.||3.09|-3.83|0.8333
71048471|NCT02618408|141605535|SUPERIORITY||Median Difference (Net)|-7.08||||0.0916|TWO_SIDED|95.0|-15.38|1.22|||Wilcoxon (Mann-Whitney)|||||1.22|-15.38|0.0916
71048472|NCT02618408|141605535|SUPERIORITY||Median Difference (Net)|-1.76||||0.7136|TWO_SIDED|95.0|-11.78|8.27|||Wilcoxon (Mann-Whitney)|||Based on the results of a prespecified interim analysis, the enrollment of the low dose SPN-810 arm was halted, and this treatment arm was dropped. Accordingly, all analysis of primary and secondary endpoints focused on the comparison of SPN-810 high dose and placebo||8.27|-11.78|0.7136
71048473|NCT02618408|141605536|SUPERIORITY|This analysis pertains to Visit 4|Mean Difference (Net)|-0.25|STANDARD_ERROR_OF_MEAN|0.108||0.0238|TWO_SIDED|95.0|-0.46|-0.03|||Mixed Models Analysis|||||-0.03|-0.46|0.0238
71048474|NCT02618408|141605536|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.123||0.0683|TWO_SIDED|95.0|-0.47|0.02|||Mixed Models Analysis|||This analysis pertains to Visit 5||0.02|-0.47|0.0683
70850492|NCT00329797|141189180|SUPERIORITY||||||<|0.0001||||||significance level = 0.05|t-test, 2 sided|||Lumbar||||<0.0001
70850493|NCT00329797|141189180|SUPERIORITY|||||||0.47||||||significance level = 0.05|t-test, 2 sided|||Hip - right||||0.47
70850494|NCT00329797|141189180|SUPERIORITY|||||||0.0002||||||significance level = 0.05|t-test, 2 sided|||Hip - left||||0.0002
70850495|NCT00329797|141189180|SUPERIORITY|||||||0.076||||||significance level = 0.05|t-test, 2 sided|||Femoral - right||||0.076
71048475|NCT02618408|141605536|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.136||0.0742|TWO_SIDED|95.0|-0.51|0.02|||Mixed Models Analysis|||This analysis pertains to Visit 6||0.02|-0.51|0.0742
71048476|NCT02618408|141605537|SUPERIORITY|This analysis pertains to Visit 4|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.105||0.3713|TWO_SIDED|95.0|-0.3|0.11|||Mixed Models Analysis|||||0.11|-0.30|0.3713
71048477|NCT02618408|141605537|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.131||0.1367|TWO_SIDED|95.0|-0.45|0.06|||Mixed Models Analysis|||This analysis pertains to Visit 5||0.06|-0.45|0.1367
71104286|NCT00928668|141715668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.38|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|1.785|2.975|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 5 mcg minus Placebo|||2.975|1.785|<0.0001
70850496|NCT00329797|141189180|SUPERIORITY|||||||0.0007||||||significance level = 0.05|t-test, 2 sided|||Femoral - left||||0.0007
70850497|NCT00329797|141189181|SUPERIORITY|||||||0.33||||||significance level = 0.01|t-test, 2 sided|||Physical subscale||||0.33
70850498|NCT00329797|141189181|SUPERIORITY|||||||0.82||||||significance level = 0.01|t-test, 2 sided|||Social subscale||||0.82
70850499|NCT00329797|141189181|SUPERIORITY|||||||0.51||||||significance level = 0.01|t-test, 2 sided|||Emotional subscale||||0.51
70850500|NCT00329797|141189181|SUPERIORITY|||||||0.25||||||significance level = 0.01|t-test, 2 sided|||Functional subscale||||0.25
70850501|NCT00329797|141189181|SUPERIORITY|||||||0.63||||||significance level = 0.01|t-test, 2 sided|||Total||||0.63
70850502|NCT00104520|141189183|SUPERIORITY_OR_OTHER|||||||0.007||0.0||||Analysis based on 2-sided test with 0.05 a priori threshold for statistical significance. No adjustments were made for multiple comparisons.|Log Rank|||H0: no difference between AZLI and placebo (pooled treatment groups) in time to need for inhaled or IV antibiotics. Assuming 2-sided significance level of 0.05, \~210 subjects (70 in each AZLI group, 35 in each placebo group) provided \>90% power to reject null hypothesis based on Lakatos normal approximation method with weights being one. Therefore, 250 subjects were to be randomized at Visit 2 (Day -28) to ensure at least 210 participants entered double-blind treatment period at Day 0.||||0.0070
71048478|NCT02618408|141605537|SUPERIORITY||Median Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.146||0.1729|TWO_SIDED|95.0|-0.49|0.09|||Mixed Models Analysis|||This analysis pertains to Visit 6||0.09|-0.49|0.1729
71048479|NCT02618408|141605538|SUPERIORITY||Mean Difference (Net)|2.15|STANDARD_ERROR_OF_MEAN|1.456||0.1407|TWO_SIDED|95.0|-0.72|5.02|||ANCOVA|||This analysis pertains to the physical functioning summary score at Visit 6.||5.02|-0.72|0.1407
71048480|NCT02618408|141605538|SUPERIORITY||Mean Difference (Net)|-0.53|STANDARD_ERROR_OF_MEAN|0.898||0.5586|TWO_SIDED|95.0|-2.29|1.24|||ANCOVA|||This analysis pertains to the psychosocial health summary score at Visit 6||1.24|-2.29|0.5586
71048481|NCT02618408|141605539|SUPERIORITY||Median Difference (Net)|-0.62|STANDARD_ERROR_OF_MEAN|2.07||0.7637|TWO_SIDED|95.0|-4.7|3.45|||ANCOVA|||This analysis pertains to the Total Stress summary score Visit 6.||3.45|-4.70|0.7637
70850503|NCT00104520|141189184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.01||||0.0196|TWO_SIDED|95.0|0.81|9.21||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included terms for treatment and baseline value.||Null hypothesis was there is no difference between 75 mg AZLI and placebo (pooled treatment groups) in change from baseline in CFQ-R RSS scores.||9.21|0.81|0.0196
70850504|NCT00104520|141189185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.28||||0.0012|TWO_SIDED|95.0|2.5|10.06||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included terms for treatment and baseline value.||Null hypothesis was there is no difference between 75 mg AZLI and placebo (pooled treatment groups) in percent change from baseline in FEV1 (L).||10.060|2.500|0.0012
70850505|NCT00104520|141189187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.659||||0.0059|TWO_SIDED|95.0|-1.125|-0.193|||ANCOVA|ANCOVA model included terms for treatment and baseline highest MIC of aztreonam for PA (\<=2, 4-8, 16-128 or \>=256 μg/mL) value.||Null hypothesis was there is no difference between 75 mg AZLI and placebo (pooled treatment groups) in mean change from baseline in log10 PA CFUs in sputum.||-0.193|-1.125|0.0059
70850506|NCT05188053|141189196|OTHER|"Sample size calculations were performed to estimate the number of subjects needed to detect a 30% difference in NRS pain AUC scores between the study groups.~30% reduction in pain was considered the minimal clinically important difference in pain control based off previous pain research.~A 30% reduction in pain would correspond with a difference of approximately 136 in area under the curve of mean pain over time."||||||0.17||||||a priori threshold p \<0.05|t-test, 2 sided|assuming unequal variance||Two-sample t-test with unequal variance. The null hypothesis is that there was no statistically significant difference between the two treatment groups based on a standard alpha value of 0.05.||||0.170
70941532|NCT00733226|141383814|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.14||0.195|TWO_SIDED|95.0|-0.55|0.03||P value was not need to adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||0.03|-0.55|0.195
71048482|NCT02618408|141605539|SUPERIORITY||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|0.895||0.8365|TWO_SIDED|95.0|-1.95|1.58|||ANCOVA|||This analysis pertains to the Parental Distress Domain score at Visit 6.||1.58|-1.95|0.8365
71048483|NCT02618408|141605539|SUPERIORITY||Mean Difference (Net)|-0.61|STANDARD_ERROR_OF_MEAN|0.829||0.4606|TWO_SIDED|95.0|-2.24|1.02|||ANCOVA|||This analysis pertains to the Parent-Child Dysfunctional Interaction score at Visit 6.||1.02|-2.24|0.4606
71048484|NCT02618408|141605539|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.837||0.8222|TWO_SIDED|95.0|-1.84|1.46|||ANCOVA|||This analysis pertains to the Difficult Child Domain score Visit 6.||1.46|-1.84|0.8222
71048485|NCT02618408|141605540|SUPERIORITY|This analysis pertains to Visit 4|Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.121||0.1031|TWO_SIDED|95.0|-0.43|0.04|||Mixed Models Analysis|||||0.04|-0.43|0.1031
71048486|NCT02618408|141605540|SUPERIORITY|This analysis pertains to Visit 5|Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.132||0.025|TWO_SIDED|95.0|-0.56|-0.04|||Mixed Models Analysis|||||-0.04|-0.56|0.0250
71104287|NCT00928668|141715668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.549|STANDARD_ERROR_OF_MEAN|0.292|<|0.0001|TWO_SIDED|95.0|2.971|4.127|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 10 mcg minus Placebo|||4.127|2.971|<0.0001
70929371|NCT05256654|141355250|SUPERIORITY||Mean Difference (Net)|-10.8|STANDARD_ERROR_OF_MEAN|6.19||0.101|TWO_SIDED|95.0|-22.2|2.3|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||2.3|-22.2|0.101
71048487|NCT02618408|141605540|SUPERIORITY|This analysis pertains to Visit 6|Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.158||0.0384|TWO_SIDED|95.0|-0.64|-0.02|||Mixed Models Analysis|||||-0.02|-0.64|0.0384
71048488|NCT02618408|141605541|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.084||0.1935|TWO_SIDED|95.0|-0.27|0.06|||ANCOVA|||This analysis pertains to the inattention subscale at Visit 6.||0.06|-0.27|0.1935
70929372|NCT05256654|141355250|SUPERIORITY||Mean Difference (Net)|-11.3|STANDARD_ERROR_OF_MEAN|4.96||0.033|TWO_SIDED|95.0|-20.6|-1.0|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-1.0|-20.6|0.033
70929373|NCT05256654|141355250|SUPERIORITY||Mean Difference (Net)|-10.9|STANDARD_ERROR_OF_MEAN|4.98||0.04|TWO_SIDED|95.0|-20.3|-0.6|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-0.6|-20.3|0.040
70929374|NCT05256654|141355251|SUPERIORITY||Mean Difference (Net)|-28.3|STANDARD_ERROR_OF_MEAN|6.79|<|0.001|TWO_SIDED|95.0|-40.5|-13.6|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-13.6|-40.5|<.001
71048489|NCT02618408|141605541|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.092||0.1445|TWO_SIDED|95.0|-0.32|0.05|||ANCOVA|||This analysis pertains to hyperactivity/Impulsivity subscale at Visit 6||0.05|-0.32|0.1445
71048490|NCT02618408|141605541|SUPERIORITY||Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.1064|TWO_SIDED|95.0|-0.36|0.03|||ANCOVA|||This analysis pertains to the oppositional defiant disorder subscale at Visit 6||0.03|-0.36|0.1064
71048491|NCT02618408|141605541|SUPERIORITY||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.082||0.1418|TWO_SIDED|95.0|-0.28|0.04|||ANCOVA|||This analysis pertains to the combined scale score at Visit 6||0.04|-0.28|0.1418
70929375|NCT05256654|141355251|SUPERIORITY||Mean Difference (Net)|-42.5|STANDARD_ERROR_OF_MEAN|4.35|<|0.001|TWO_SIDED|95.0|-50.5|-33.2|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-33.2|-50.5|<.001
70929376|NCT05256654|141355251|SUPERIORITY||Mean Difference (Net)|-44.8|STANDARD_ERROR_OF_MEAN|4.2|<|0.001|TWO_SIDED|95.0|-52.5|-35.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-35.9|-52.5|<.001
71048492|NCT02566993|141605561|SUPERIORITY||Hazard Ratio (HR)|0.967||||0.9029|TWO_SIDED|95.0|0.815|1.148|||Log Rank|Stratified log-rank test||||1.148|0.815|0.9029
71048493|NCT02566993|141605562|SUPERIORITY|||||||0.2826|||||||Normal test|||||||0.2826
71048494|NCT02566993|141605563|SUPERIORITY|||||||0.6216|||||||Normal test|||||||0.6216
71048495|NCT02566993|141605564|SUPERIORITY|||||||0.9708|||||||Normal test|||||||0.9708
70929377|NCT05167864|141355254|SUPERIORITY|||||||0.13519|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 3|||0.13519
70929378|NCT05167864|141355254|SUPERIORITY|||||||0.8556|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 3|||0.8556
70929379|NCT05167864|141355254|SUPERIORITY|||||||0.46943|TWO_SIDED|95.0|||||Wilcoxon signed-rank test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 3|||0.46943
70929380|NCT05167864|141355254|SUPERIORITY|||||||0.0449|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 3|||0.0449
70929381|NCT05167864|141355254|SUPERIORITY|||||||0.504|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 30|||0.504
71048496|NCT02566993|141605565|SUPERIORITY||Hazard Ratio (HR)|0.831||||0.3257|TWO_SIDED|95.0|0.693|0.996|||Log Rank|Stratified log-rank test||||0.996|0.693|0.3257
71048497|NCT02566993|141605566|SUPERIORITY|||||||0.0851|||||||Normal test|||||||0.0851
71048498|NCT02566993|141605567|SUPERIORITY|||||||0.0129|||||||Normal test|||||||0.0129
71048499|NCT02566993|141605569|SUPERIORITY|||||||0.6616|||||||Binomial test|||||||0.6616
71048500|NCT02566993|141605570|SUPERIORITY||Hazard Ratio (HR)|0.581||||0.0012|TWO_SIDED|95.0|0.416|0.812|||Log Rank|||||0.812|0.416|0.0012
71048501|NCT02566993|141605571|SUPERIORITY||Hazard Ratio (HR)|0.921|||||TWO_SIDED|95.0|0.744|1.14||||||||1.140|0.744|
71048502|NCT02566993|141605572|SUPERIORITY||Hazard Ratio (HR)|0.688|||||TWO_SIDED|95.0|0.549|0.863||||||||0.863|0.549|
71048503|NCT02566993|141605574|SUPERIORITY||Hazard Ratio (HR)|0.921|||||TWO_SIDED|95.0|0.616|1.376||||||||1.376|0.616|
71048504|NCT02566993|141605575|SUPERIORITY||Hazard Ratio (HR)|0.504|||||TWO_SIDED|95.0|0.346|0.736||||||||0.736|0.346|
71048505|NCT02566993|141605576|SUPERIORITY||Hazard Ratio (HR)|1.122|||||TWO_SIDED|95.0|0.84|1.5||||||||1.500|0.840|
71048506|NCT02566993|141605577|SUPERIORITY||Hazard Ratio (HR)|1.306|||||TWO_SIDED|95.0|0.955|1.786||||||||1.786|0.955|
71048507|NCT02566993|141605579|SUPERIORITY||Hazard Ratio (HR)|0.915|||||TWO_SIDED|95.0|0.455|1.843||||||||1.843|0.455|
71048508|NCT02566993|141605580|SUPERIORITY||Hazard Ratio (HR)|1.092|||||TWO_SIDED|95.0|0.506|2.36||||||||2.360|0.506|
71048509|NCT02566993|141605581|SUPERIORITY||Hazard Ratio (HR)|0.923|||||TWO_SIDED|95.0|0.765|1.113||||||||1.113|0.765|
71048510|NCT02566993|141605582|SUPERIORITY||Hazard Ratio (HR)|0.788|||||TWO_SIDED|95.0|0.645|0.961||||||||0.961|0.645|
71048511|NCT02566993|141605584|SUPERIORITY||Hazard Ratio (HR)|0.903|||||TWO_SIDED|95.0|0.624|1.307||||||||1.307|0.624|
71048512|NCT02566993|141605585|SUPERIORITY||Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.392|0.799||||||||0.799|0.392|
71048513|NCT02566993|141605586|SUPERIORITY||Hazard Ratio (HR)|1.291|||||TWO_SIDED|95.0|0.838|1.99||||||||1.990|0.838|
71048514|NCT02566993|141605587|SUPERIORITY||Hazard Ratio (HR)|1.29|||||TWO_SIDED|95.0|0.824|2.019||||||||2.019|0.824|
70929382|NCT05167864|141355254|SUPERIORITY|||||||0.772193|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 30|||0.772193
70929383|NCT05167864|141355254|SUPERIORITY|||||||0.5414|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 30|||0.5414
70929384|NCT05167864|141355254|SUPERIORITY|||||||0.07|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 30|||0.070
70929385|NCT05167864|141355254|SUPERIORITY|||||||0.546|TWO_SIDED|95.0|||||Wilcoxon signed rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 90|||0.546
71048515|NCT02566993|141605589|SUPERIORITY||Hazard Ratio (HR)|1.032|||||TWO_SIDED|95.0|0.403|2.641||||||||2.641|0.403|
71104288|NCT00928668|141715668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.208|STANDARD_ERROR_OF_MEAN|0.296|<|0.0001|TWO_SIDED|95.0|3.622|4.794|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Form 20 mcg minus Placebo|||4.794|3.622|<0.0001
71104289|NCT00928668|141715669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.907|STANDARD_ERROR_OF_MEAN|0.295|<|0.0001|TWO_SIDED|95.0|1.322|2.492|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 2 mcg minus Placebo|||2.492|1.322|<0.0001
71104290|NCT00928668|141715669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.474|STANDARD_ERROR_OF_MEAN|0.299|<|0.0001|TWO_SIDED|95.0|1.822|3.066|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 5 mcg minus Placebo|||3.066|1.822|<0.0001
70929386|NCT05167864|141355254|SUPERIORITY|||||||0.756|TWO_SIDED|95.0|||||Wilcoxon signed rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 90|||0.756
71048516|NCT02566993|141605590|SUPERIORITY||Hazard Ratio (HR)|1.013|||||TWO_SIDED|95.0|0.373|2.75||||||||2.750|0.373|
71048517|NCT03127644|141605604|SUPERIORITY||Treatment difference in slopes|-0.00496|STANDARD_ERROR_OF_MEAN|0.00038|<|0.0001|TWO_SIDED|95.0|-0.00571|-0.0042|||Mixed Models Analysis|Confirmatory testing proceeded sequentially (ZS 10g TID, then ZS 5g TID).|Negative exponential rate of change relative to placebo indicates more rapid reduction (correction) of S-K.|Exponential rate of change in S-K through to 48 hours was analysed with a mixed effect model (random slope model).||-0.00420|-0.00571|<0.0001
70929387|NCT05167864|141355254|SUPERIORITY|||||||0.7|TWO_SIDED|95.0|||||Wilcoxon signed rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 90|||0.700
70929388|NCT05167864|141355254|SUPERIORITY|||||||0.397|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 90|||0.397
70929389|NCT05167864|141355254|SUPERIORITY|||||||0.093|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 180|||0.093
71048518|NCT03127644|141605604|SUPERIORITY||Treatment difference in slopes|-0.00261|STANDARD_ERROR_OF_MEAN|0.000385|<|0.001|TWO_SIDED|95.0|-0.00337|-0.00185|||Mixed Models Analysis|Confirmatory testing proceeded sequentially (ZS 10g TID, then ZS 5g TID).|Negative exponential rate of change relative to placebo indicates more rapid reduction (correction) of S-K.|Exponential rate of change in S-K through to 48 hours was analysed with a mixed effect model (random slope model).||-0.00185|-0.00337|<0.001
71048519|NCT03127644|141605605|SUPERIORITY||Odds Ratio (OR)|46.495|||<|0.0001|TWO_SIDED|95.0|10.142|213.152|||Regression, Logistic|||Logistic regression model including treatment and baseline S-K as explanatory variables was used.||213.152|10.142|<0.0001
71048520|NCT03127644|141605605|SUPERIORITY||Odds Ratio (OR)|71.835|||<|0.0001|TWO_SIDED|95.0|13.497|382.337|||Regression, Logistic|||Logistic regression model including treatment and baseline S-K as explanatory variables was used.||382.337|13.497|<0.0001
71048521|NCT03127644|141605606|SUPERIORITY||Treatment difference in slopes|-0.00231|STANDARD_ERROR_OF_MEAN|0.000645||0.0004|TWO_SIDED|95.0|-0.00359|-0.00104|||Mixed Models Analysis||Negative exponential rate of change relative to placebo indicates more rapid reduction (correction) of S-K.|Exponential rate of change in S-K through to 24 hours was analysed with a mixed effect model (random slope model).||-0.00104|-0.00359|0.0004
70929390|NCT05167864|141355254|SUPERIORITY|||||||0.323|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 180|||0.323
70929391|NCT05167864|141355254|SUPERIORITY|||||||0.182|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) tothe patient satisfaction improvement of line in the forehead post injection day 180|||0.182
71048522|NCT03127644|141605606|OTHER||Treatment difference in slopes|-0.00401|STANDARD_ERROR_OF_MEAN|0.000637|<|0.0001|TWO_SIDED|95.0|-0.00527|-0.00275|||Mixed Models Analysis||Negative exponential rate of change relative to placebo indicates more rapid reduction (correction) of S-K.|Exponential rate of change in S-K through to 24 hours was analysed with a mixed effect model (random slope model).||-0.00275|-0.00527|<0.0001
71048523|NCT03127644|141605607|SUPERIORITY||Odds Ratio (OR)|1.347||||0.6167|TWO_SIDED|95.0|0.419|4.329|||Regression, Logistic|||Logistic regression model including treatment and baseline S-K as explanatory variables was used.||4.329|0.419|0.6167
71104291|NCT00928668|141715669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.327|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|2.752|3.902|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 10 mcg minus Placebo|||3.902|2.752|<0.0001
71104292|NCT00928668|141715669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.22|STANDARD_ERROR_OF_MEAN|0.294|<|0.0001|TWO_SIDED|95.0|3.637|4.803|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Form 20 mcg minus Placebo|||4.803|3.637|<0.0001
71048524|NCT03127644|141605607|SUPERIORITY||Odds Ratio (OR)|15.334|||<|0.0001|TWO_SIDED|95.0|4.006|58.697|||Regression, Logistic|||Logistic regression model including treatment and baseline S-K as explanatory variables was used.||58.697|4.006|<0.0001
71048525|NCT03127644|141605611|SUPERIORITY|||||||0.0586||||||Nominal p value|Log Rank|||||||0.0586
71048526|NCT03127644|141605611|SUPERIORITY|||||||0.0006||||||Nominal p value|Log Rank|||||||0.0006
71048527|NCT03127644|141605612|SUPERIORITY|||||||0.025||||||Nominal p value|Log Rank|||||||0.0250
71048528|NCT03127644|141605612|SUPERIORITY|||||||0.0064||||||Nominal p value|Log Rank|||||||0.0064
71048529|NCT04972123|141605623|SUPERIORITY|The primary end point was evaluated via a large sample Z-test for proportions. The test statistic was compared to a Pocock monitoring boundary at both an interim analysis and at the final analysis.||||||0.521||||||The primary end point was evaluated via a large sample Z-test for proportions. The test statistic was compared to a Pocock monitoring boundary at both an interim analysis and at the final analysis.|Large sample Z-test for population prop|The test statistic was compared to a Pocock monitoring boundary at both an interim analysis and at the final analysis.||Primary endpoint -- ITT primary endpoint analysis||||0.521
71048530|NCT04972123|141605624|SUPERIORITY|Time to event was compared between groups via a log-rank test.||||||0.574||||||Time to event was compared between groups via a log-rank test.|Log Rank|||Secondary endpoint -- Time to event for evaluable ITT population who had a primary event.||||0.574
71048531|NCT04972123|141605625|SUPERIORITY|Incidence of asystole were compared between groups using Fisher exact test.||||||1||||||Incidence of asystole were compared between groups using Fisher exact test.|Fisher Exact|Incidence of asystole were compared between groups using Fisher exact test.||Secondary endpoint -- Incidence of asystolic pause \> 3 seconds for evaluable ITT population who had a primary event.||||1.000
71048532|NCT04972123|141605626|SUPERIORITY|Reporting for the 1 hour fatigue score only.||||||0.732||||||Measures of fatigue were compared between groups using the Wilcoxon rank-sum test.|Wilcoxon (Mann-Whitney)|Measures of fatigue were compared between groups using the Wilcoxon rank-sum test.||Secondary endpoint -- Measures of Fatigue for evaluable ITT population who had a primary event.||||0.732
71048533|NCT04972123|141605626|SUPERIORITY|Reporting for the 4 hour fatigue score only.||||||0.591||||||Measures of fatigue were compared between groups using the Wilcoxon rank-sum test.|Wilcoxon (Mann-Whitney)|Measures of fatigue were compared between groups using the Wilcoxon rank-sum test.||Secondary endpoint -- Measures of Fatigue for evaluable ITT population who had a primary event.||||0.591
71048534|NCT04972123|141605626|SUPERIORITY|Reporting for the 8 hour fatigue score only.||||||0.034||||||Measures of fatigue were compared between groups using the Wilcoxon rank-sum test.|Wilcoxon (Mann-Whitney)|Measures of fatigue were compared between groups using the Wilcoxon rank-sum test.||Secondary endpoint -- Measures of Fatigue for evaluable ITT population who had a primary event.||||0.034
71048535|NCT01156142|141605627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4|||<|0.001|TWO_SIDED|95.0|-6.7|-2.1|||Wilcoxon (Mann-Whitney)|||||-2.1|-6.7|<0.001
71048536|NCT01156142|141605628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.0018|TWO_SIDED|95.0|0.1|5.1|||Wilcoxon (Mann-Whitney)|||||5.1|0.1|0.0018
71048537|NCT01156142|141605629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.6||||0.001|TWO_SIDED|95.0|2.9|8.3|||Wilcoxon (Mann-Whitney)|||||8.3|2.9|0.001
71048538|NCT01156142|141605630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.0297|TWO_SIDED|95.0|-1.2|4.6|||Wilcoxon (Mann-Whitney)|||||4.6|-1.2|0.0297
71048539|NCT01156142|141605631|SUPERIORITY_OR_OTHER|||||||0.1392|||||||Chi-squared|||At 2 hours after initial mouthwash||||0.1392
71048540|NCT01156142|141605631|SUPERIORITY_OR_OTHER|||||||0.6989|||||||Chi-squared|||At 4 hours after initial mouthwash||||0.6989
70929392|NCT05167864|141355254|SUPERIORITY|||||||0.88|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 180|||0.880
71048541|NCT01156142|141605632|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Chi-squared|||||||0.0018
71048542|NCT02337959|141605675|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED|||||Level of significance (alpha) = 0.05|t-test, 2 sided|||||||0.028
71048543|NCT02337959|141605676|SUPERIORITY_OR_OTHER|||||||0||||||level of significance (alpha) = 0.05|t-test, 1 sided|||Both the predicate and investigational images were randomized for the monitors. Predicate images could display on the left or the right and vice versa with the investigational. There were formulas in the spreadsheet that gave the preferences a numerical value, and subsequently became part of the analysis.||||0.000
71048544|NCT00895947|141605682|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||Overall comparison of treatment groups for incidence of ILI|Chi-squared|||||||0.25
71048545|NCT00895947|141605682|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||Comparision of ILI incidence in subjects age 50 and older at baseline.|Chi-squared|||||||0.01
71048546|NCT00895947|141605682|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||Comparison of ILI in subjects age \< 50 at baseline|Chi-squared|||||||0.32
71048547|NCT00895947|141605682|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||Comparison of ILI incidence in subjects vaccinated against seasonal influenza prior to enrollment.|Chi-squared|||||||0.01
71048548|NCT00895947|141605682|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||Comparison of ILI incidence in subjects not vaccinated against seasonal influenza prior to enrollment|Chi-squared|||||||0.45
71048549|NCT00895947|141605682|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Comparison of ILI incidence in male subjects|Chi-squared|||||||0.03
71048550|NCT00895947|141605682|SUPERIORITY_OR_OTHER|||||||0.99||95.0||||Comparison of ILI incidence in female subjects|Chi-squared|||||||0.99
71048551|NCT00895947|141605683|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||Proportion of subjects reporting any cold/flu symptoms during treatment|Chi-squared|||||||0.16
71048552|NCT00895947|141605683|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Proportion of subjects reporting moderate to severe feverishness|Chi-squared|||||||0.03
71048553|NCT00895947|141605683|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||Proportion of subjects reporting moderate to severe head congestion|Chi-squared|||||||0.04
71048554|NCT00895947|141605683|SUPERIORITY_OR_OTHER|||||||0.07||95.0||||Proportion of subjects reporting moderate to severe sore throat|Chi-squared|||||||0.07
71048555|NCT00895947|141605684|SUPERIORITY_OR_OTHER|||||||0.39||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to think clearly|Chi-squared|||||||0.39
71048556|NCT00895947|141605684|SUPERIORITY_OR_OTHER|||||||0.15||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to sleep well|Chi-squared|||||||0.15
70850507|NCT02447302|141189202|SUPERIORITY||Difference in least square mean|-0.99|STANDARD_ERROR_OF_MEAN|0.42|=|0.0091|TWO_SIDED|90.0|-1.68|-0.3||The analysis was performed using an analysis of covariance (ANCOVA) model that incorporated treatment, current oral corticosteroid use, prior exposure to tumor necrosis factor alpha (TNFα) antagonists, and baseline value as covariate.|ANCOVA|The analysis compared the adapted MCS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.|Estimated least square mean difference in etrasimod 2 mg from placebo|The primary comparison in the study was between etrasimod 2 mg versus placebo.||-0.30|-1.68|= 0.0091
70850508|NCT02447302|141189202|SUPERIORITY||Difference in least square mean|-0.43|STANDARD_ERROR_OF_MEAN|0.41|=|0.1457|TWO_SIDED|90.0|-1.11|0.24||The analysis was performed using an ANCOVA model that incorporated treatment, current oral corticosteroid use, prior exposure to TNFα antagonists, and baseline value as covariate.|ANCOVA|The analysis compared the adapted MCS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.|Estimated least square mean difference in etrasimod 1 mg from placebo|||0.24|-1.11|= 0.1457
70850509|NCT02447302|141189203|SUPERIORITY||MH estimate for difference in percentage|24.4|STANDARD_ERROR_OF_MEAN|8.87|=|0.003|TWO_SIDED|90.0|9.8|39.0||Mantel-Haenszel (MH) estimated common risk difference adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.|Mantel Haenszel|The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.|MH estimated difference in etrasimod 2 mg from Placebo|The primary comparison in the study was between etrasimod 2 mg versus placebo.||39.0|9.8|= 0.003
70850510|NCT02447302|141189203|SUPERIORITY||MH estimate for difference in percentage|4.1|STANDARD_ERROR_OF_MEAN|7.98|=|0.3059|TWO_SIDED|90.0|-9.1|17.2||MH estimated common risk difference adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.|Mantel Haenszel|The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.|MH estimated difference in etrasimod 1 mg from Placebo|||17.2|-9.1|= 0.3059
70850511|NCT02447302|141189204|SUPERIORITY||Difference in least square mean|-0.84|STANDARD_ERROR_OF_MEAN|0.29|=|0.002|TWO_SIDED|90.0|-1.32|-0.36||The analysis was performed using an ANCOVA model that incorporated treatment, current oral corticosteroid use, prior exposure to TNFα antagonists, and baseline value as covariate.|ANCOVA|The analysis compared the 2-component MCS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.|Estimated least square mean difference in etrasimod 2 mg from placebo|The primary comparison in the study was between etrasimod 2 mg versus placebo.||-0.36|-1.32|= 0.0020
70850512|NCT02447302|141189204|SUPERIORITY||Difference in least square mean|-0.39|STANDARD_ERROR_OF_MEAN|0.28|=|0.0858|TWO_SIDED|90.0|-0.85|0.08||The analysis was performed using an ANCOVA model that incorporated treatment, current oral corticosteroid use, prior exposure to TNFα antagonists, and baseline value as covariate.|ANCOVA|The analysis compared the 2-component MCS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.|Estimated least square mean difference in etrasimod 1 mg from placebo|||0.08|-0.85|= 0.0858
70850513|NCT02447302|141189205|SUPERIORITY||Difference in least square mean|-1.27|STANDARD_ERROR_OF_MEAN|0.55|=|0.01|TWO_SIDED|90.0|-2.17|-0.37||The analysis was performed using an ANCOVA model that incorporated treatment, current oral corticosteroid use, prior exposure to TNFα antagonists, and baseline value as covariate.|ANCOVA|The analysis compared the TMS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.|Estimated least square mean difference in etrasimod 2 mg from placebo|The primary comparison in the study was between etrasimod 2 mg versus placebo.||-0.37|-2.17|= 0.0100
70850514|NCT02447302|141189205|SUPERIORITY||Difference in least square mean|-0.6|STANDARD_ERROR_OF_MEAN|0.53|=|0.1277|TWO_SIDED|90.0|-1.48|0.27||The analysis was performed using an ANCOVA model that incorporated treatment, current oral corticosteroid use, prior exposure to TNFα antagonists, and baseline value as covariate.|ANCOVA|The analysis compared the TMS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.|Estimated least square mean difference in etrasimod 1 mg from placebo|||0.27|-1.48|= 0.1277
70850515|NCT02447302|141189206|SUPERIORITY||Odds Ratio (OR)|2.78|||=|0.0071|TWO_SIDED|90.0|1.4|5.51||The analysis was performed using an ordered logistic regression model with terms for treatment, current oral corticosteroid use, and prior exposure to TNFα antagonists.|ANCOVA|The analysis compared the odds of achieving higher trichotomous composite score between the groups using 1-sided test at 0.05 level of significance.||The primary comparison in the study was between etrasimod 2 mg versus placebo.||5.51|1.40|= 0.0071
70850516|NCT02447302|141189206|SUPERIORITY||Odds Ratio (OR)|1.61|||=|0.1192|TWO_SIDED|90.0|0.83|3.14||The analysis was performed using an ordered logistic regression model with terms for treatment, current oral corticosteroid use, and prior exposure to TNFα antagonists.|ANCOVA|The analysis compared the odds of achieving higher trichotomous composite score between the groups using 1-sided test at 0.05 level of significance.||||3.14|0.83|= 0.1192
70850517|NCT02447302|141189207|SUPERIORITY||MH estimate for difference in percentage|25.8|STANDARD_ERROR_OF_MEAN|7.47|=|0.0003|TWO_SIDED|90.0|13.5|38.1||The analysis was performed using MH method that was adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.|Mantel Haenszel|The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.|MH estimated difference in etrasimod 2 mg from Placebo|The primary comparison in the study was between etrasimod 2 mg versus placebo.||38.1|13.5|= 0.0003
70850518|NCT02447302|141189207|SUPERIORITY||MH estimate for difference in percentage|7.1|STANDARD_ERROR_OF_MEAN|6.46|=|0.136|TWO_SIDED|90.0|-3.5|17.7||The analysis was performed using MH method that was adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.|Mantel Haenszel|The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.|MH estimated difference in etrasimod 1 mg from Placebo|||17.7|-3.5|= 0.1360
70929393|NCT05167864|141355254|SUPERIORITY|||||||0.496|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) tothe patient satisfaction improvement in the forehead post injection day 3|||0.496
70929394|NCT05167864|141355254|SUPERIORITY|||||||0.905|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 3|||0.905
70929395|NCT05167864|141355254|SUPERIORITY|||||||0.692|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 3|||0.692
70929396|NCT05167864|141355254|SUPERIORITY|||||||0.262|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 3|||0.262
70929397|NCT05167864|141355254|SUPERIORITY|||||||0.828|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 30|||0.828
70929398|NCT05167864|141355254|SUPERIORITY|||||||0.268|TWO_SIDED|95.0|||||Wilcoxon signed rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 30|||0.268
70929399|NCT05167864|141355254|SUPERIORITY|||||||0.975|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 30|||0.975
70929400|NCT05167864|141355254|SUPERIORITY|||||||0.499|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 30|||0.499
70929401|NCT05167864|141355254|SUPERIORITY|||||||0.75|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 90|||0.750
70929402|NCT05167864|141355254|SUPERIORITY|||||||0.433|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 90|||0.433
70929403|NCT05167864|141355254|SUPERIORITY|||||||0.834|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 90|||0.834
70929404|NCT05167864|141355254|SUPERIORITY|||||||0.834|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 90|||0.834
70929405|NCT05167864|141355254|SUPERIORITY|||||||0.526|TWO_SIDED|95.0|||||Wilcoxon signed rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 180|||0.526
70929406|NCT05167864|141355254|SUPERIORITY|||||||0.816|TWO_SIDED|95.0|||||Wilcoxon singed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 180|||0.816
70929407|NCT05167864|141355254|SUPERIORITY|||||||0.65|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 180|||0.650
70929408|NCT05167864|141355254|SUPERIORITY|||||||0.095|TWO_SIDED|95.0|||||wilcoxon rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 180|||0.095
70929409|NCT05167864|141355254|SUPERIORITY|||||||0.618|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 3|||0.618
70929410|NCT05167864|141355254|SUPERIORITY|||||||0.34|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 3|||0.340
70929411|NCT05167864|141355254|SUPERIORITY|||||||0.15|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 3|||0.150
70929412|NCT05167864|141355254|SUPERIORITY|||||||0.361|TWO_SIDED|95.0|||||Wilcoxon signed rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 3|||0.361
70929413|NCT05167864|141355254|SUPERIORITY|||||||0.428|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 30|||0.428
70929414|NCT05167864|141355254|SUPERIORITY|||||||0.834|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 30|||0.834
70929415|NCT05167864|141355254|SUPERIORITY|||||||0.318|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 30|||0.318
70929416|NCT05167864|141355254|SUPERIORITY|||||||0.311|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 30|||0.311
70929417|NCT05167864|141355254|SUPERIORITY|||||||0.885|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 90|||0.885
70929418|NCT05167864|141355254|SUPERIORITY|||||||0.457|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 90|||0.457
70929419|NCT05167864|141355254|SUPERIORITY|||||||0.745|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 90|||0.745
70929420|NCT05167864|141355254|SUPERIORITY|||||||0.757|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 90|||0.757
70929421|NCT05167864|141355254|SUPERIORITY|||||||0.562|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 180|||0.562
70929422|NCT05167864|141355254|SUPERIORITY|||||||0.828|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 180|||0.828
70929423|NCT05167864|141355254|SUPERIORITY|||||||0.005|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 180|||0.005
70929424|NCT05167864|141355254|SUPERIORITY|||||||0.437|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 180|||0.437
70929425|NCT05207982|141355279|OTHER|||||||||||||||||This study utilized a multiple baseline single case experimental design in which analysis of the daily weights (for each participant) involved discontinuous growth curve analysis using multi-level modeling. Separate models were developed for each participant which include the daily weights from the baseline, treatment and follow-up phases. Given the nature of the data, we hypothesized different slopes for the baseline vs treatment phases. Overall weight change was a primary outcome measure.|Multiple baseline single case experimental design in which analysis of the daily weights (for each participant) involved discontinuous growth curve analysis using multi-level modeling.|||
70929426|NCT04089059|141355280|SUPERIORITY|Poisson regression for comparison of incidence rate against performance goal (0.43)|||||<|0.0001|||||||Poisson Regression|||||||<0.0001
70929427|NCT04089059|141355283|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Comparison of HF Hospitalization events 6 months before implant vs 6 months after implant||||<0.0001
70929428|NCT04089059|141355284|SUPERIORITY|Comparison of the incidence rate of HF hospitalizations or emergency department / hospital outpatient IV diuretic visits of Former Control Arm versus Modified Intent to Treat Arm at 6 months post-implant/Subgroup Analysis||||||0.0697|||||||Poisson Regression|||||||0.0697
70929429|NCT04089059|141355287|SUPERIORITY|Comparison of mPAP values at baseline to values at 6 months.||||||0.0952|||||||Wilcoxon (Mann-Whitney)|||||||0.0952
70929430|NCT04089059|141355287|SUPERIORITY|Comparison of mPAP values at baseline to values at 6 months.||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.0090
70929431|NCT04089059|141355287|SUPERIORITY|Comparison of mPAP values at baseline to values at 6 months.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
70929432|NCT04089059|141355289|SUPERIORITY|Comparison of KCCQ at baseline and at 6 months||||||0.0026|||||||Wilcoxon (Mann-Whitney)|||||||0.0026
70929433|NCT04089059|141355290|OTHER|Test of difference in distribution of NYHA class from baseline (all patients were class III at baseline).|||||<|0.0001|||||||Chi-squared|||The New York Heart Association (NYHA) Classification is a system used to evaluate and classify the severity of heart failure based on symptoms, patient's physical activity, and quality of life. Its scale ranges from class 1 to 4 with class 1 indicating the least severe heart failure symptoms (i.e., the best functionality) and class 4 indicating the most severe heart failure symptoms (i.e., the poorest functionality), with higher classes indicating poorer functioning as relates to heart failure.||||<0.0001
70929434|NCT04089059|141355291|SUPERIORITY|Comparison of baseline 6MWT vs 6 month 6MWT.||||||0.1086|||||||Wilcoxon (Mann-Whitney)|||||||0.1086
70929435|NCT04089059|141355294|SUPERIORITY|Compare NTproBNP at baseline with 6 months||||||0.0628|||||||Wilcoxon (Mann-Whitney)|||||||0.0628
70929436|NCT03728608|141355317|SUPERIORITY|||||||0.92|||||||survival analysis|||||||0.92
70929437|NCT03728608|141355318|SUPERIORITY|||||||0.65|||||||survival analysis|||||||0.65
70929438|NCT03728608|141355319|SUPERIORITY|||||||0.96|||||||survival analysis|||||||0.96
70929439|NCT03728608|141355320|SUPERIORITY|||||||0.77|||||||survival analysis|||||||0.77
70929440|NCT03728608|141355321|SUPERIORITY|||||||0.43|||||||Regression, Logistic|||||||0.43
70929441|NCT03728608|141355322|SUPERIORITY|||||||0.97|||||||Regression, Logistic|||||||0.97
70929442|NCT03728608|141355323|SUPERIORITY|||||||0.97|||||||Regression, Logistic|||||||0.97
70929443|NCT03728608|141355324|SUPERIORITY|||||||0.79|||||||Regression, Logistic|||||||0.79
70929444|NCT01828112|141355376|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.36|0.67|||Log Rank|||||0.67|0.36|<0.001
70929445|NCT05586490|141355450|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|-0.6375||||0.429|TWO_SIDED|||||A priori threshold for statistical significance is p \< 0.05.|t-test, 2 sided|Paired samples t-test, df = 7||||||0.429
70929446|NCT05586490|141355451|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|3.75||||0.351|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 7||||||0.351
70929447|NCT05586490|141355452|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|-0.013||||0.937|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 7||||||0.937
70929448|NCT05586490|141355453|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|-14.8||||0.044|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 7||||||0.044
70929449|NCT05586490|141355454|SUPERIORITY||Mean Difference (Net)|-0.68||||0.42|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (alternate device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.42
70929450|NCT05586490|141355454|SUPERIORITY||Mean Difference (Net)|0.57||||0.5|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (research device group and no device group) controlling for pre-trial measurements, gender, and age.||||||0.50
70929451|NCT05586490|141355455|SUPERIORITY||Mean Difference (Net)|-0.03||||0.986|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (alternate device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.986
70929452|NCT05586490|141355455|SUPERIORITY||Mean Difference (Net)|-1.25||||0.479|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (research device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.479
70929453|NCT05586490|141355456|SUPERIORITY||Mean Difference (Net)|-0.195||||0.098|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (alternate device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.098
70929454|NCT05586490|141355456|SUPERIORITY||Mean Difference (Net)|-0.039||||0.729|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (research device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.729
71014036|NCT05299359|141534691|NON_INFERIORITY|If the lower limit of the 95% CI is \>= 0.67, then the immune response to a single heterologous booster vaccination of TAK-019 is considered to be non-inferior of that to the primary series of TAK-019.|LS Mean Difference|1.18|||||TWO_SIDED|95.0|0.95|1.47||||||GMT ratio was calculated GMT of TAK-019-3001 on Day 15 divided by GMT of TAK-019-1501 study on Day 36.||1.47|0.95|
70929455|NCT05586490|141355457|SUPERIORITY||Mean Difference (Net)|-8.15||||0.058|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (alternate device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.0580
70929456|NCT05586490|141355457|SUPERIORITY||Mean Difference (Net)|-1.54||||0.718|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (research device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.718
71014037|NCT02652793|141534739|SUPERIORITY|Single-arm pilot study to assess BMD improvement after switching therapy. Null hypothesis: no change in lumbar spine BMD at Week 48. Sample size of 45 planned to detect a 2% increase with 90% power (α=0.025). Final analysis included 30 participants.|Mean Difference (Final Values)|0.01|STANDARD_DEVIATION|0.03||0.0239|TWO_SIDED|95.0|0.001|0.019||Statistical test applied to lumbar spine BMD only. P-value reflects within-group change from baseline to Week 48.|Regression, Linear|Per-protocol analysis; missing data excluded|Represents mean change in lumbar spine BMD from baseline to Week 48.|Single-arm study; no comparator group||0.019|0.001|0.0239
71104293|NCT00928668|141715670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.229|STANDARD_ERROR_OF_MEAN|0.271|<|0.0001|TWO_SIDED|95.0|0.692|1.766|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 2 mcg minus Placebo|||1.766|0.692|<0.0001
71104294|NCT00928668|141715670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.825|STANDARD_ERROR_OF_MEAN|0.274|<|0.0001|TWO_SIDED|95.0|1.281|2.369|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 5 mcg minus Placebo|||2.369|1.281|<0.0001
70929457|NCT05586490|141355459|SUPERIORITY||Mean Difference (Net)|0.063||||0.816|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (alternate device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.816
71014038|NCT02652793|141534739|SUPERIORITY|Single-arm pilot study to assess BMD improvement after switching therapy. Null hypothesis: no change in left hip BMD at Week 48. Sample size of 45 planned to detect a 2% increase with 90% power (α=0.025). Final analysis included 30 participants.|Mean Difference (Final Values)|0.013|STANDARD_DEVIATION|0.03||0.0046|TWO_SIDED|95.0|0.004|0.023||Left hip|Regression, Linear|Statistical test applied to left hip BMD only. P-value reflects within-group change from baseline to Week 48.|Represents mean change in left hip BMD from baseline to Week 48|Single-arm study; no comparator group||0.023|0.004|0.0046
71014039|NCT04579666|141534756|SUPERIORITY||Difference in LS Mean|-3.0||||0.7205|TWO_SIDED|95.0|-19.5|13.5|||ANCOVA|||Analysis of covariance (ANCOVA) was used to analyze the ranks of the CAFS score with treatment as a fixed effect, adjusted for baseline ALSFRS-R total score, time from symptom onset, baseline Log neurofilament light chain (NfL), and the randomization stratification factors (location of first muscle weakness and use of riluzole and edaravone).||13.5|-19.5|0.7205
71014040|NCT04579666|141534761|SUPERIORITY||Difference in LS Mean|-0.7||||0.6447|TWO_SIDED|95.0|-3.5|2.2|||MMRM|||The mixed-effect model for repeated measures (MMRM) included fixed categorical effects for treatment, week, and the week-by-treatment interaction, as well as the continuous, fixed covariate of the baseline value of the endpoint, and the week-by-baseline interaction, baseline log NfL, time from symptoms onset to the first dose of study drug, and randomization stratification factors location of first muscle weakness and use of riluzole and/or edaravone).||2.2|-3.5|0.6447
71014041|NCT04579666|141534762|SUPERIORITY||Difference in LS Mean|-6.6||||0.0949|TWO_SIDED|95.0|-14.3|1.2|||MMRM|||The MMRM included fixed categorical effects for treatment, week, and the week-by-treatment interaction, as well as the continuous, fixed covariate of the baseline value of the endpoint, and the week-by-baseline interaction, baseline log NfL, time from symptoms onset to the first dose of study drug, and randomization stratification factors (location of first muscle weakness and use of riluzole and/or edaravone).||1.2|-14.3|0.0949
71014042|NCT04579666|141534763|SUPERIORITY||Difference in LS Mean|-0.19||||0.0935|TWO_SIDED|95.0|-0.42|0.03|||MMRM|||The MMRM included fixed categorical effects for treatment, week, and the week-by-treatment interaction, as well as the continuous, fixed covariate of the baseline value of the endpoint, and the week-by-baseline interaction, baseline log NfL, time from symptoms onset to the first dose of study drug, and randomization stratification factors (location of first muscle weakness and use of riluzole and/or edaravone).||0.03|-0.42|0.0935
71014043|NCT04579666|141534765|SUPERIORITY||Difference in LS Mean|6.5||||0.0069|TWO_SIDED|95.0|1.8|11.1|||MMRM|||The MMRM included fixed categorical effects for treatment, week, and the week-by-treatment interaction, as well as the continuous, fixed covariate of the baseline value of the endpoint, and the week-by-baseline interaction, baseline log NfL, time from symptoms onset to the first dose of study drug, and randomization stratification factors (location of first muscle weakness and use of riluzole and/or edaravone).||11.1|1.8|0.0069
71014044|NCT04359758|141534790|SUPERIORITY|||||||0.14|||||||Chi-squared|||The study was powered assuming 10% genetic testing uptake UC compared to 35% in ST. assuming these uptake rates and a two-tailed alpha of 0.05, a sample size of n=50 per arm would yield greater than 80% power.||||0.14
71014045|NCT04359758|141534790|SUPERIORITY||Odds Ratio (OR)|2.57||||0.039|TWO_SIDED|95.0|1.05|6.29|||Regression, Logistic|||Because education and marital status have been associated with genetic testing participation in prior research, we conducted a follow-up analysis in which we adjusted for education and marital status.||6.29|1.05|0.039
71014046|NCT04359758|141534791|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|101 degrees of freedom.||||||0.13
71014047|NCT04359758|141534792|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|df=102||||||0.78
71104295|NCT00928668|141715670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.114|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|1.578|2.65|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 10 mcg minus Placebo|||2.650|1.578|<0.0001
71014048|NCT04359758|141534793|SUPERIORITY|||||||0.97|||||||ANCOVA|df = 1, 101||Analysis of PROMIS anxiety||||0.97
71014049|NCT04359758|141534793|SUPERIORITY|||||||0.34|||||||ANCOVA|df = 1, 101||Analysis of PROMIS Depression||||0.34
71014050|NCT00505765|141534797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_DEVIATION|1.5||0.21|TWO_SIDED||||||ANCOVA|||||||0.21
71014051|NCT00505765|141534797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_DEVIATION|1.5||0.44|TWO_SIDED||||||ANCOVA|||||||0.44
71014052|NCT03841331|141534802|SUPERIORITY||Treatment Effect|-1.4||||0.5861|TWO_SIDED|95.0|-13.9|11.1|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used|At Week 10||11.1|-13.9|0.5861
71014053|NCT03841331|141534803|SUPERIORITY||Treatment Effect|-0.7||||0.5651|TWO_SIDED|95.0|-10.1|8.7|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 2||8.7|-10.1|0.5651
71048557|NCT00895947|141605684|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to breathe easily|Chi-squared|||||||0.66
71014054|NCT03841331|141534803|SUPERIORITY||Treatment Effect|-4.1||||0.7769|TWO_SIDED|95.0|-14.8|6.7|||Cochran-Mantel-Haenszel|||At Week 4|95% Wald confidence intervals for the treatment difference was used.|6.7|-14.8|0.7769
71048558|NCT00895947|141605684|SUPERIORITY_OR_OTHER|||||||0.48||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to walk, climb stairs and exercise|Chi-squared|||||||0.48
71048559|NCT00895947|141605684|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to perform daily activities|Chi-squared|||||||0.26
71048560|NCT00895947|141605684|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to work outside the home|Chi-squared|||||||0.25
71014055|NCT03841331|141534803|SUPERIORITY||Treatment Effect|2.8||||0.3285|TWO_SIDED|95.0|-9.1|14.8|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 6||14.8|-9.1|0.3285
71014056|NCT03841331|141534803|SUPERIORITY||Treatment Effect|-2.3||||0.6525|TWO_SIDED|95.0|-14.4|9.8|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 8||9.8|-14.4|0.6525
71048561|NCT00895947|141605684|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to work inside the home|Chi-squared|||||||0.20
71048562|NCT00895947|141605684|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to interact with others|Chi-squared|||||||0.20
70941533|NCT00733226|141383815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22|STANDARD_ERROR_OF_MEAN|0.82||0.452|TWO_SIDED|95.0|-2.87|0.42||P value was not need to adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||0.42|-2.87|0.452
71014057|NCT03841331|141534804|SUPERIORITY||Treatment effect|0.0||||0.4952|TWO_SIDED|95.0|-5.6|5.7|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 2||5.7|-5.6|0.4952
71014058|NCT03841331|141534804|SUPERIORITY||Treatment effect|5.2||||0.0891|TWO_SIDED|95.0|-2.3|12.7|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 4||12.7|-2.3|0.0891
71014059|NCT03841331|141534804|SUPERIORITY||Treatment effect|-4.2||||0.8447|TWO_SIDED|95.0|-12.1|3.7|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 6||3.7|-12.1|0.8447
71014060|NCT03841331|141534804|SUPERIORITY||Treatment effect|1.0||||0.4174|TWO_SIDED|95.0|-7.5|9.4|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 8||9.4|-7.5|0.4174
71014061|NCT03841331|141534804|SUPERIORITY||Treatment effect|2.7||||0.2756|TWO_SIDED|95.0|-5.8|11.2|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 10||11.2|-5.8|0.2756
71014062|NCT03841331|141534805|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.4409|TWO_SIDED|95.0|-0.49|0.57|||ANOVA|||At Week 2||0.57|-0.49|0.4409
71014063|NCT03841331|141534805|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.5496|TWO_SIDED|95.0|-0.65|0.57||At week 4|ANOVA|||At Week 4||0.57|-0.65|0.5496
71014064|NCT03841331|141534805|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.6311|TWO_SIDED|95.0|-0.78|0.55|||ANOVA|||At Week 6||0.55|-0.78|0.6311
71014065|NCT03841331|141534805|SUPERIORITY||Mean Difference (Final Values)|0.4738||||0.02|TWO_SIDED|95.0|-0.65|0.69|||ANOVA|||At Week 8||0.69|-0.65|0.02
71014066|NCT03841331|141534805|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.3948|TWO_SIDED|95.0|-0.6|0.78|||ANOVA|||At Week 10||0.78|-0.60|0.3948
71014067|NCT03841331|141534807|SUPERIORITY||Mean Difference (Final Values)|2.44||||0.244|TWO_SIDED|95.0|-4.98|9.87|||ANOVA|||At Week 2||9.87|-4.98|0.2440
71048563|NCT00895947|141605684|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to live personal life|Chi-squared|||||||0.32
71048564|NCT00895947|141605685|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||Proportion of subjects in each group reporting one or more days they felt sick|Chi-squared|||||||0.66
71048565|NCT00895947|141605685|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||Proportion of subjects in each group reporting one or more days they missed work|Chi-squared|||||||0.88
71048566|NCT00895947|141605685|SUPERIORITY_OR_OTHER|||||||1||95.0||||Proportion of subjects in each group reporting one or more days they visited the doctor|Chi-squared|||||||1.0
71048567|NCT00895947|141605685|SUPERIORITY_OR_OTHER|||||||0.54||95.0||||Proportion of subjects in each group reporting one or more days they visited the pharmacy|Chi-squared|||||||0.54
71048568|NCT00895947|141605685|SUPERIORITY_OR_OTHER|||||||0.24||95.0||||Proportion of subjects in each group reporting one or more days they took cold/flu medication|Chi-squared|||||||0.24
71048569|NCT00895947|141605685|SUPERIORITY_OR_OTHER|||||||0.89||95.0||||Proportion of subjects in each group reporting one or more days they skipped a planned activity|Chi-squared|||||||0.89
70929458|NCT05586490|141355459|SUPERIORITY||Mean Difference (Net)|-0.0048||||0.985|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (research device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.985
70929459|NCT05586490|141355460|SUPERIORITY||Mean Difference (Net)|6.33||||0.59|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (alternate device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.59
70929460|NCT05586490|141355460|SUPERIORITY||Mean Difference (Net)|8.16||||0.51|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (research device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.51
70929461|NCT05280574|141355503|OTHER||Ratio of geometric means|0.75|||<|0.05|TWO_SIDED|95.0|0.51|1.1|||Distinct-effects GEE model||Average relative effect of unblinded versus blinded monitoring across the 5-component composite (SpO2 \<85%, RR \>30/min, RR \<4/min, HR \<45/min, HR \>130/min) of cumulative durations.||We assessed the treatment effect of unblinded versus blinded monitoring across the 5-component primary outcome composite of cumulative durations by estimating the average relative effect on the log-transformed count data (counts of observations beyond a given threshold at 1 Hz). Specifically, we employed a distinct-effects (i.e., separate treatment effect estimated for each component) generalized estimating equation (GEE) model to account for within-subject correlation across components with the vector of the 5 cumulative durations as the dependent variable and treatment as independent. We then averaged the component-specific effects and tested whether the average effect equals zero (on the log scale), and reported results as the ratio of geometric means of unblinded versus blinded monitoring.|1.1|0.51|< 0.05
70929462|NCT02361216|141355512|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|6.29|||<|0.001|TWO_SIDED|95.0|2.82|14.0|||Cochran-Mantel-Haenszel|||AKclear100 at Week 8: full analysis set. The null hypothesis was that there is no difference at Week 8 in AKclear100 rates between ingenol mebutate gel 0.027% and vehicle gel. This hypothesis was tested against the 2-sided alternative of a difference between the 2 treatment groups.||14|2.82|<0.001
70929463|NCT02361216|141355513|SUPERIORITY||Ratio of clearance rates|6.81|||<|0.001|TWO_SIDED|95.0|4.16|11.1|||Cochran-Mantel-Haenszel||Mantel-Haenszel estimate (0.027% relative to vehicle), adjusted for pooled sites|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||11.1|4.16|<0.001
70929464|NCT02361216|141355514|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|6.53|||<|0.001|TWO_SIDED|95.0|4.04|10.5|||Mantel Haenszel|||The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The pre-specified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||10.5|4.04|<0.001
70929465|NCT02361216|141355515|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance|0.28|||<|0.001|TWO_SIDED|95.0|0.24|0.32||Negative binominal regression with log baseline count as offset variable and treatment group, anatomical location stratum and pooled site as factors.|Cochran-Mantel-Haenszel|||The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||0.32|0.24|<0.001
70929466|NCT03505008|141355516|NON_INFERIORITY|Two-sided 90% CI for the intergroup difference in SDAI remission rates to exceed the non-inferiority margin of -15%|Risk Difference (RD)|0.0|||||TWO_SIDED|90.0||||||||||||
70929467|NCT01730937|141355523|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0554|TWO_SIDED|90.0|0.59|1.01|||Log Rank||Reference arm = Sorafenib Alone|Original design: Hypothesized 28% reduction (HR=0.72) with SBRT (corresponds to median OS = 14.5 months). Assuming an exponential distribution and constant hazards, 292 patients were required to reach 238 OS events, with 80% statistical power, a 1-sided α of 0.05. Revised design (see limitations/caveats): For same above hypotheses, at least 155 OS events from 193 randomized patients provided 65% statistical power, with a 1-sided α of 0.05.||1.01|0.59|0.0554
71048570|NCT00895947|141605686|SUPERIORITY_OR_OTHER|||||||0.61||95.0||||Proportion of subjects in each group with a confirmed viral respiratory infection|Chi-squared|||||||0.61
71048571|NCT00895947|141605686|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Proportion of subjects in each group with a moderate/severe viral respiratory infection|Chi-squared|||||||0.003
71048572|NCT00895947|141605686|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Proportion of subjects in each group with a moderate/severe influenza infection|Chi-squared|||||||0.03
71048573|NCT00895947|141605686|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Proportion of subjects in each group with a moderate/severe viral respiratory infection other than influenza|Chi-squared|||||||0.03
71048574|NCT00895947|141605687|SUPERIORITY_OR_OTHER|||||||0.54||95.0||||Proportion of subjects meeting the definition of acute respiratory illness during treatment|Chi-squared|||||||0.54
71048575|NCT00895947|141605687|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||Proportion of subjects meeting with moderate/severe acute respiratory illness during treatment|Chi-squared|||||||0.06
71048576|NCT00895947|141605687|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Proportion of subjects with moderate/severe febrile acute respiratory illness during treatment|Chi-squared|||||||0.03
71048577|NCT00895947|141605687|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||Proportion of subjects with moderate/severe afebrile acute respiratory illness during treatment|Chi-squared|||||||0.60
71048578|NCT05472662|141605692|EQUIVALENCE|Equivalence was demonstrated if the 95% CI of the adjusted mean difference in relative change from baseline in FEV1 between HFA-152a and HFA-134a was within the equivalence limits \[-10% ; +10%\].|Adjusted mean difference|1.86||||0.113|TWO_SIDED|95.0|-0.48|4.2|||ANCOVA|||"Statistical analysis performed on the data at 15 min post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject, and period as fixed effects and FEV1 baseline as covariate."||4.20|-0.48|0.113
71048579|NCT05472662|141605693|EQUIVALENCE|Equivalence was demonstrated if the 95% CI of the adjusted mean difference in relative change from baseline in FEV1 between HFA-152a and HFA-134a was within the equivalence limits \[-10% ; +10%\].|Adjusted mean difference|0.58||||0.483|TWO_SIDED|95.0|-1.1|2.25|||ANCOVA|||"Statistical analysis performed on the data at 5 min post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject, and period as fixed effects and FEV1 baseline as covariate."||2.25|-1.10|0.483
71048580|NCT05472662|141605693|EQUIVALENCE|Equivalence was demonstrated if the 95% CI of the adjusted mean difference in relative change from baseline in FEV1 between HFA-152a and HFA-134a was within the equivalence limits \[-10% ; +10%\].|Adjusted mean difference|0.23||||0.782|TWO_SIDED|95.0|-1.45|1.9|||ANCOVA|||"Statistical analysis performed on the data at 30 min post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject, and period as fixed effects and FEV1 baseline as covariate."||1.90|-1.45|0.782
70929468|NCT01730937|141355524|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.034|TWO_SIDED|95.0|0.48|0.99||Two-sided significance level = 0.05|Gray's test||Reference arm = Sorafenib Alone|||0.99|0.48|0.034
70929469|NCT01730937|141355525|SUPERIORITY||Hazard Ratio (HR)|0.55||||0.0001|TWO_SIDED|95.0|0.4|0.75||Two-sided significance level=0.05|Log Rank||Reference arm = Sorafenib Alone|||0.75|0.40|0.0001
71048581|NCT05472662|141605693|EQUIVALENCE|Equivalence was demonstrated if the 95% CI of the adjusted mean difference in relative change from baseline in FEV1 between HFA-152a and HFA-134a was within the equivalence limits \[-10% ; +10%\].|Adjusted mean difference|-0.4||||0.599|TWO_SIDED|95.0|-1.97|1.16|||ANCOVA|||"Statistical analysis performed on the data at 1 h post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject, and period as fixed effects and FEV1 baseline as covariate."||1.16|-1.97|0.599
71048582|NCT05472662|141605693|EQUIVALENCE|Equivalence was demonstrated if the 95% CI of the adjusted mean difference in relative change from baseline in FEV1 between HFA-152a and HFA-134a was within the equivalence limits \[-10% ; +10%\].|Adjusted mean difference|-0.13||||0.815|TWO_SIDED|95.0|-1.24|0.99|||ANCOVA|||"Statistical analysis performed on the data at 1.5 h post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject, and period as fixed effects and FEV1 baseline as covariate."||0.99|-1.24|0.815
71048583|NCT05472662|141605693|EQUIVALENCE|Equivalence was demonstrated if the 95% CI of the adjusted mean difference in relative change from baseline in FEV1 between HFA-152a and HFA-134a was within the equivalence limits \[-10% ; +10%\].|Adjusted mean difference|-0.69||||0.294|TWO_SIDED|95.0|-2.01|0.64|||ANCOVA|||"Statistical analysis performed on the data at 3 h post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject, and period as fixed effects and FEV1 baseline as covariate."||0.64|-2.01|0.294
71048584|NCT05472662|141605694|OTHER||Adjusted mean difference|0.015||||0.519|TWO_SIDED|95.0|-0.032|0.061|||ANCOVA|||"Statistical analysis performed on the data at 5 min post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate."|Assess differences between treatment groups.|0.061|-0.032|0.519
71048585|NCT05472662|141605694|OTHER||Adjusted mean difference|0.061||||0.085|TWO_SIDED|95.0|-0.009|0.13|||ANCOVA|||"Statistical analysis performed on the data at 15 min post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate."|Assess differences between treatment groups.|0.130|-0.009|0.085
71048586|NCT05472662|141605694|OTHER||Adjusted mean difference|0.004||||0.858|TWO_SIDED|95.0|-0.045|0.054|||ANCOVA|||"Statistical analysis performed on the data at 30 min post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate."|Assess differences between treatment groups.|0.054|-0.045|0.858
71048587|NCT05472662|141605694|OTHER||Adjusted mean difference|-0.011||||0.632|TWO_SIDED|95.0|-0.058|0.036|||ANCOVA|||"Statistical analysis performed on the data at 1 h post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate."|Assess differences between treatment groups.|0.036|-0.058|0.632
71048588|NCT05472662|141605694|OTHER||Adjusted mean difference|-0.003||||0.846|TWO_SIDED|95.0|-0.038|0.031|||ANCOVA|||"Statistical analysis performed on the data at 1.5 h post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate."|Assess differences between treatment groups.|0.031|-0.038|0.846
70929470|NCT01866163|141355539|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|30.27|||<|0.001|TWO_SIDED|95.0|9.72|94.3|||Mantel Haenszel|||Multiple imputations were used to handle missing data.||94.30|9.72|<0.001
71048589|NCT05472662|141605694|OTHER||Adjusted mean difference|-0.024||||0.282|TWO_SIDED|95.0|-0.068|0.021|||ANCOVA|||"Statistical analysis performed on the data at 3 h post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate."|Assess differences between treatment groups.|0.021|-0.068|0.282
71048590|NCT04620135|141605706|SUPERIORITY||The least squares (LS) mean difference|-1.74|STANDARD_ERROR_OF_MEAN|0.221|<|1e-05|TWO_SIDED|95.0|-2.17|-1.31||Analyzed as ANCOVA with mean diurnal IOP at Week 4 as the response, baseline mean diurnal IOP as a covariate, and treatment as a main effect, using the ITT population with MCMC and regression-based multiple imputation to impute missing data.|ANCOVA||||The primary analysis of the primary endpoint employed an analysis of covariance (ANCOVA) with mean diurnal IOP at Week 4 as the response, baseline mean diurnal IOP as a covariate, and treatment as a main effect, using the ITT population with Markov Chain Monte Carlo (MCMC) and regression based multiple imputation (MI) techniques to impute missing data. The least squares (LS) mean difference (netarsudil - ripasudil) was presented with a 2-sided p-value and 95% confidence intervals (CIs). A success criterion for the superiority of netarsudil to ripasudil was defined as the 2-sided p value ≤ 0.05 for testing the difference (netarsudil QD - ripasudil BID) to 0 and the point estimate of the LS mean difference of \< 0.|-1.31|-2.17|<0.00001
71048591|NCT04988152|141605709|SUPERIORITY||Ratio of geometric least squares means|1.0724|||||TWO_SIDED|90.0|0.8519|1.35|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with Cmax as the dependent variable, and ethnicity and body weight were covariates.|||1.3500|0.8519|
70929471|NCT01866163|141355540|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.28|||<|0.001|TWO_SIDED|95.0|-3.9|-2.67|||ANOVA|||The mean value and CIs were adjusted for the effect of pooled centres and baseline m-PASI. Multiple imputation was used to handle missing data.||-2.67|-3.90|<0.001
70929472|NCT01866163|141355541|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.27|||<|0.001|TWO_SIDED|95.0|-1.76|-0.78|||ANOVA|||The mean value and CIs were adjusted for the effect of pooled centres and baseline m-PASI. Multiple imputation was used to handle missing data.||-0.78|-1.76|<0.001
70929473|NCT04204083|141355566|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
70929474|NCT04204083|141355567|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
70929475|NCT04204083|141355568|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
71048592|NCT04988152|141605710|OTHER||Ratio of geometric least squares means|1.0513|||||TWO_SIDED|90.0|0.9281|1.1908|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with AUC(D1-29) as the dependent variable, and ethnicity and body weight were covariates.|||1.1908|0.9281|
71048593|NCT04988152|141605713|OTHER||Ratio of geometric least squares means|1.6999|||||TWO_SIDED|90.0|1.15|2.5129|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with Cmax as the dependent variable, and ethnicity and body weight were covariates.|||2.5129|1.1500|
71048594|NCT04988152|141605714|OTHER||Ratio of geometric least squares means|1.5869|||||TWO_SIDED|90.0|1.1236|2.2413|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with AUC(D1-29) as the dependent variable, and ethnicity and body weight were covariates.|||2.2413|1.1236|
71048595|NCT04988152|141605729|OTHER||Ratio of geometric least squares means|1.0724|||||TWO_SIDED|90.0|0.8519|1.35|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with Cmax as the dependent variable, and ethnicity and body weight were covariates.|||1.3500|0.8519|
71048596|NCT04988152|141605731|OTHER||Ratio of geometric least squares means|1.0673|||||TWO_SIDED|90.0|0.9286|1.2268|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with AUClast as the dependent variable, and ethnicity and body weight were covariates.|||1.2268|0.9286|
71048597|NCT04988152|141605735|OTHER||Ratio of geometric least squares means|1.6999|||||TWO_SIDED|90.0|1.15|2.5129|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with Cmax as the dependent variable, and ethnicity and body weight were covariates.|||2.5129|1.1500|
71048598|NCT04988152|141605737|OTHER||Ratio of geometric least squares means|1.5766|||||TWO_SIDED|90.0|1.1777|2.1106|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with AUClast as the dependent variable, and ethnicity and body weight were covariates|||2.1106|1.1777|
71048599|NCT00311311|141605769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036||||0.0445|TWO_SIDED|95.0|0.001|0.07||P-value and 95% CI for least square (LS) mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|12 months post-transplant||0.070|0.001|0.0445
71048600|NCT00311311|141605769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.034||||0.0288|TWO_SIDED|95.0|0.004|0.064||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|18 months post-transplant||0.064|0.004|0.0288
71048601|NCT00311311|141605769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.0269|TWO_SIDED|95.0|0.004|0.06||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|24 months post-transplant||0.060|0.004|0.0269
71048602|NCT00311311|141605769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028||||0.097|TWO_SIDED|95.0|-0.005|0.06||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|36 months post-transplant||0.060|-0.005|0.0970
71048603|NCT00311311|141605772|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.74|||<|0.0001|TWO_SIDED|95.0|0.39|1.09||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|TC 12 Months Post-transplant||1.09|0.39|<.0001
71048604|NCT00311311|141605772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.0022|TWO_SIDED|95.0|0.15|0.67||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|LDL 12 Months Post-transplant||0.67|0.15|0.0022
71048605|NCT00311311|141605772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.1612|TWO_SIDED|95.0|-0.03|0.19||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|HDL 12 Months Post-transplant||0.19|-0.03|0.1612
71048606|NCT00311311|141605772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56||||0.0005|TWO_SIDED|95.0|0.26|0.86||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|Tg 12 Months Post-transplant||0.86|0.26|0.0005
71048607|NCT00311311|141605772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.0006|TWO_SIDED|95.0|0.3|1.02||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|TC 18 Months Post-transplant||1.02|0.30|0.0006
70929476|NCT01960452|141355715|OTHER|Group comparison, for absolute (spatially z-score normalized across all electrodes for each subject)||||||0.2791|||||||t-test, 2 sided|||Only reporting values for approximate 10-20 channel CP1||||0.2791
70929477|NCT01960452|141355715|OTHER|Group comparison, for absolute multiple comparisons correction across electrodes using threshold free cluster enhancement (TFCE)||||||0.9|||||||t-test, 2 sided|||||||0.9
70929478|NCT01960452|141355716|OTHER|Group comparison, for both absolute (spatially z-score normalized across all electrodes for each subject)||||||0.1069|||||||t-test, 2 sided|||Only reporting values for approximate 10-20 channel CP1||||0.1069
70929479|NCT01960452|141355716|OTHER|Group comparison, for absolute multiple comparisons correction across electrodes using threshold free cluster enhancement (TFCE)||||||0.546|||||||t-test, 2 sided|||||||0.546
70929480|NCT01960452|141355717|OTHER|Group comparison, for absolute (spatially z-score normalized across all electrodes for each subject)||||||0.2918|||||||t-test, 2 sided|||Only reporting values for approximate 10-20 channel CP1||||0.2918
70929481|NCT01960452|141355717|OTHER|Group comparison, for absolute multiple comparisons correction across electrodes using threshold free cluster enhancement (TFCE)||||||0.761|||||||t-test, 2 sided|||||||0.761
71014068|NCT03841331|141534807|SUPERIORITY||Mean Difference (Final Values)|-1.27||||0.6349|TWO_SIDED|95.0|-9.2|6.65|||ANOVA|||At Week 4||6.65|-9.20|0.6349
71048608|NCT00311311|141605772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.0126|TWO_SIDED|95.0|0.08|0.61||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|LDL 18 Months Post-transplant||0.61|0.08|0.0126
70929482|NCT03655028|141355736|SUPERIORITY|||||||0.85||||||The co-variate used in the analysis was the 6 minute walk distance at baseline.|ANCOVA|||||||0.85
70929483|NCT03655028|141355737|SUPERIORITY|||||||0.307||||||The co-variant used to adjust the ANCOVA was the baseline step count/day.|ANCOVA|||||||.307
70929484|NCT03655028|141355738|SUPERIORITY|||||||0.106||||||this comparison is made between distance walked during 6MW at 12 weeks and distance walked during 6MW at 24 weeks|ANCOVA|||||||0.106
70929485|NCT03655028|141355739|SUPERIORITY|||||||0.26||||||Baseline PCS score was used at the co-variate|ANCOVA|||||||0.26
70929486|NCT03655028|141355740|SUPERIORITY|||||||0.85||||||Covariate was baseline MCS score|ANCOVA|||||||0.85
70929487|NCT03655028|141355741|SUPERIORITY|||||||0.025|||||||t-test, 2 sided|||||||0.025
70929488|NCT05618587|141355755|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
71048609|NCT00311311|141605772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.238|TWO_SIDED|95.0|-0.04|0.17||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|HDL 18 Months Post-transplant||0.17|-0.04|0.2380
70929489|NCT05618587|141355756|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.79
70929490|NCT05618587|141355757|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||0.68
70929491|NCT05618587|141355758|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||||||0.89
71014069|NCT03841331|141534807|SUPERIORITY||Mean Difference (Final Values)|0.3407||||1.91|TWO_SIDED|95.0|-6.4|10.23|||ANOVA|||At Week 6||10.23|-6.40|1.91
70929492|NCT05618587|141355759|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||||||0.75
70929493|NCT05618587|141355760|SUPERIORITY|||||||1|||||||Barnard unconditional exact test|||||||1.0
70929494|NCT05618587|141355761|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||||||0.28
70929495|NCT05618587|141355762|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
71014070|NCT03841331|141534807|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.496|TWO_SIDED|95.0|-8.52|8.97|||ANOVA|||At Week 10||8.97|-8.52|0.4960
71048610|NCT00311311|141605772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58||||0.0003|TWO_SIDED|95.0|0.27|0.88||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|Tg 18 Months Post-transplant||0.88|0.27|0.0003
70929496|NCT05618587|141355763|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
70929497|NCT05618587|141355764|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.50
70929498|NCT05618587|141355765|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||||||0.29
70929499|NCT05618587|141355766|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||0.35
70929500|NCT03442309|141355769|NON_INFERIORITY|NI margin for arrest difference of 10%|Mean Difference (Final Values)|-0.11|||||TWO_SIDED|95.0|-0.22|0.01||||||||0.01|-.22|
70929501|NCT03442309|141355770|NON_INFERIORITY|Non-inferiority OR (OR δ, 0.63)|Odds Ratio (OR)|0.94|||||TWO_SIDED|90.0|0.82|1.08||||||||1.08|0.82|
70929502|NCT05290493|141355813|SUPERIORITY|||||||0.0672|||||||Mixed Models Analysis|||||||0.0672
70929503|NCT05290493|141355814|SUPERIORITY|||||||0.2045|||||||Mixed Models Analysis|||||||0.2045
70929504|NCT05290493|141355815|SUPERIORITY|||||||0.2931|||||||Mixed Models Analysis|||||||0.2931
70929505|NCT05290493|141355816|SUPERIORITY|||||||0.7799|||||||Mixed Models Analysis|||||||0.7799
70929506|NCT05290493|141355817|SUPERIORITY|||||||0.7974|||||||Mixed Models Analysis|||||||0.7974
70929507|NCT05290493|141355818|SUPERIORITY|||||||0.8286|||||||Mixed Models Analysis|||||||0.8286
70929508|NCT05419830|141355820|OTHER|Three-group ANCOVA comparisons were completed using pre- to post-intervention changes in sleep time dip in systolic BP. Analysis was adjusted for baseline value of the outcome||||||0.65|||||||ANCOVA|||||||0.65
70929509|NCT05419830|141355821|OTHER|Three-group ANCOVA comparisons were completed using pre- to post-intervention changes in nocturia frequency. Analysis was adjusted for baseline value of the outcome||||||0.66|||||||ANCOVA|||||||0.66
70929510|NCT05419830|141355822|OTHER|Three-group ANCOVA comparisons were completed using pre- to post-intervention changes in NPi. Analysis was adjusted for baseline value of the outcome||||||0.14|||||||ANCOVA|||||||0.14
70929511|NCT05419830|141355823|OTHER|Three-group ANCOVA comparisons were completed using pre- to post-intervention changes in PSQI scores. Analysis was adjusted for baseline value of the outcome||||||0.2|||||||ANCOVA|||||||0.2
70929512|NCT05419830|141355824|OTHER|Three-group ANCOVA comparisons were completed using pre- to post-intervention changes in sleep efficiency. Analysis was adjusted for baseline value of the outcome||||||0.02|||||||ANCOVA|||||||0.02
70929513|NCT03677141|141355825|SUPERIORITY||Difference in rates|-4.77|||||TWO_SIDED|95.0|-30.61|21.07||||||||21.07|-30.61|
71014071|NCT02743117|141534810|SUPERIORITY_OR_OTHER||Rate Difference|-1.3|||||TWO_SIDED|95.0|-8.1|1.3||||||||1.3|-8.1|
71014072|NCT02743117|141534811|SUPERIORITY_OR_OTHER||Rate Difference|-8.2|||||TWO_SIDED|95.0|-22.2|4.6||||||Up to Day 8||4.6|-22.2|
71014073|NCT02743117|141534811|SUPERIORITY_OR_OTHER||Rate Difference|-7.4|||||TWO_SIDED|95.0|-21.6|5.9||||||Up to Day 15||5.9|-21.6|
70929514|NCT05838027|141355866|SUPERIORITY|All panel-data marginal models use robust standard errors. Categorical outcomes were assessed with ordered logistic models and continuous outcomes were assessed with GEE population-averaged models, except Medication Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Odds Ratio (OR)|3.24|||||TWO_SIDED|95.0|0.84|12.55||||||||12.55|0.84|
71014074|NCT01207219|141534815|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||The p-value for statistical significance in these analyses was 0.01 adjusted for multiple comparisons .|Mixed Models Analysis|mixed-model analysis with a repeated-measures approach including an unstructured variance matrix||Data analysis was based on the Intention-to-Treatment (ITT) method. Differences between the three intervention groups over time (baseline and 12 weeks) were assessed with a Group x Time interaction term. A priori comparisons of the active intervention groups with the waitlist group were carried out with the same strategy if analyses including all the three groups meet the criterion of statistical significance (P\<0.01).||||<0.01
71014075|NCT00766727|141534820|SUPERIORITY||Mean Difference (Final Values)|-31.88|STANDARD_DEVIATION|14.25|||TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||
71014076|NCT03948646|141534826|OTHER||Odds Ratio (OR)|2.0||||0.0029|TWO_SIDED|95.0|1.27|3.15|||Regression, Logistic|||||3.15|1.27|0.0029
71048611|NCT00311311|141605772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.0065|TWO_SIDED|95.0|0.17|1.0||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|TC 24 Months Post-transplant||1.00|0.17|0.0065
71014077|NCT03948646|141534827|OTHER||Mean Difference (Net)|-21.77|STANDARD_ERROR_OF_MEAN|9.994||0.0296|TWO_SIDED|95.0|-41.37|-2.16|||ANCOVA|||||-2.16|-41.37|0.0296
71014078|NCT00634933|141534838|SUPERIORITY_OR_OTHER|||||||0.061|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A 2-sided Cochran-Mantel-Haenszel test (CMH), stratified by prior anti-tumor necrosis factor (anti-TNF) use and geographic region, was used.||||0.061
71014079|NCT00634933|141534838|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.120
70929515|NCT05838027|141355867|SUPERIORITY|All panel-data marginal models use robust standard errors. Categorical outcomes were assessed with ordered logistic models and continuous outcomes were assessed with GEE population-averaged models, except Medication Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.24|2.64||||||||2.64|0.24|
71014080|NCT00634933|141534839|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.570
71014081|NCT00634933|141534839|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.200
71014082|NCT00634933|141534839|SUPERIORITY_OR_OTHER|||||||0.616|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.616
71014083|NCT00634933|141534839|SUPERIORITY_OR_OTHER|||||||0.671|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.671
71014084|NCT00634933|141534839|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.108
71014085|NCT00634933|141534839|SUPERIORITY_OR_OTHER|||||||0.174|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.174
71014086|NCT00634933|141534839|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.010
71104296|NCT00928668|141715670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.645|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|2.11|3.181|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Form 20 mcg minus Placebo|||3.181|2.110|<0.0001
71014087|NCT00634933|141534839|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.029
71014088|NCT00634933|141534839|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.006
71014089|NCT00634933|141534839|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.021
71014090|NCT00634933|141534839|SUPERIORITY_OR_OTHER|||||||0.062|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.062
71014091|NCT00634933|141534839|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.049
71014092|NCT00634933|141534839|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 24: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.030
71014093|NCT00634933|141534839|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 24: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.005
71014094|NCT00634933|141534840|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.014
71014095|NCT00634933|141534840|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.025
71014096|NCT00634933|141534840|SUPERIORITY_OR_OTHER|||||||0.794|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.794
71014097|NCT00634933|141534840|SUPERIORITY_OR_OTHER|||||||0.966|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.966
71014098|NCT00634933|141534840|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.770
71014099|NCT00634933|141534840|SUPERIORITY_OR_OTHER|||||||0.456|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.456
71014100|NCT00634933|141534840|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.880
71014101|NCT00634933|141534840|SUPERIORITY_OR_OTHER|||||||0.814|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.814
71048612|NCT00311311|141605772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.0845|TWO_SIDED|95.0|-0.04|0.6||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|LDL 24 Months Post-transplant||0.60|-0.04|0.0845
71048613|NCT00311311|141605772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.3742|TWO_SIDED|95.0|-0.06|0.16||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|HDL 24 Months Post-transplant||0.16|-0.06|0.3742
71048614|NCT00311311|141605772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.0006|TWO_SIDED|95.0|0.27|0.92||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|Tg 24 Months Post-transplant||0.92|0.27|0.0006
71014102|NCT00634933|141534840|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.042
71014103|NCT00634933|141534840|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.035
71014104|NCT00634933|141534840|SUPERIORITY_OR_OTHER|||||||0.086|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.086
71014105|NCT00634933|141534840|SUPERIORITY_OR_OTHER|||||||0.082|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.082
71014106|NCT00634933|141534841|SUPERIORITY_OR_OTHER|||||||0.325|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.325
71014107|NCT00634933|141534841|SUPERIORITY_OR_OTHER|||||||0.338|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.338
71014108|NCT00634933|141534841|SUPERIORITY_OR_OTHER|||||||0.983|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.983
71014109|NCT00634933|141534841|SUPERIORITY_OR_OTHER|||||||0.296|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.296
71048615|NCT00311311|141605772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.1488|TWO_SIDED|95.0|-0.16|1.03||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|TC 36 Months Post-transplant||1.03|-0.16|0.1488
71104297|NCT01838226|141715673|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.5|TWO_SIDED|95.0|-1.3|2.8|||Mixed Models Analysis|||||2.8|-1.3|0.50
71014110|NCT00634933|141534841|SUPERIORITY_OR_OTHER|||||||0.575|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.575
71014111|NCT00634933|141534841|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||1.000
71014112|NCT00634933|141534841|SUPERIORITY_OR_OTHER|||||||0.573|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.573
71014113|NCT00634933|141534841|SUPERIORITY_OR_OTHER|||||||0.563|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.563
71014114|NCT00634933|141534841|SUPERIORITY_OR_OTHER|||||||0.768|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.768
71014115|NCT00634933|141534841|SUPERIORITY_OR_OTHER|||||||0.977|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.977
71014116|NCT00634933|141534841|SUPERIORITY_OR_OTHER|||||||0.249|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.249
71014117|NCT00634933|141534841|SUPERIORITY_OR_OTHER|||||||0.268|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.268
71014118|NCT00634933|141534841|SUPERIORITY_OR_OTHER|||||||0.089|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 24: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.089
71014119|NCT00634933|141534841|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 24: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.079
71014120|NCT00634933|141534856|SUPERIORITY_OR_OTHER|||||||0.106|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.106
71014121|NCT00634933|141534856|SUPERIORITY_OR_OTHER|||||||0.322|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.322
71014122|NCT00634933|141534856|SUPERIORITY_OR_OTHER|||||||0.059|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4 Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.059
71014123|NCT00634933|141534856|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.250
71104298|NCT01838226|141715674|SUPERIORITY||Mean Difference (Net)|0.9|||||TWO_SIDED|95.0|-1.3|3.1|||Mixed Models Analysis|||||3.1|-1.3|
71104299|NCT01838226|141715675|SUPERIORITY||Mean Difference (Net)|-2.6|||||TWO_SIDED|95.0|-4.9|-0.2||||||||-0.2|-4.9|
71104300|NCT03232567|141715695|SUPERIORITY|||||||0.2451|||||||Fisher Exact|||||||0.2451
71104301|NCT03232567|141715695|SUPERIORITY|||||||0.0063|||||||Fisher Exact|||||||0.0063
70929516|NCT05838027|141355868|SUPERIORITY|All panel-data marginal models use robust standard errors. Categorical outcomes were assessed with ordered logistic models and continuous outcomes were assessed with GEE population-averaged models, except Medication Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|0.52|||||TWO_SIDED|95.0|-3.78|4.82||||||||4.82|-3.78|
70929517|NCT05838027|141355869|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-1.01|1.4||||||||1.40|-1.01|
70929518|NCT05838027|141355870|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|-2.71|||||TWO_SIDED|95.0|-7.43|2.0||||||||2.00|-7.43|
70929519|NCT05838027|141355871|SUPERIORITY|All panel-data marginal models use robust standard errors. Categorical outcomes were assessed with ordered logistic models and continuous outcomes were assessed with GEE population-averaged models, except Medication Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|-0.65|||||TWO_SIDED|95.0|-5.45|4.16||||||||4.16|-5.45|
70929520|NCT05838027|141355872|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|IRR|1.12|||||TWO_SIDED|95.0|0.46|2.74||||||||2.74|0.46|
70929521|NCT05838027|141355873|SUPERIORITY|All panel-data marginal models use robust standard errors. Categorical outcomes were assessed with ordered logistic models and continuous outcomes were assessed with GEE population-averaged models, except Medication Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|-0.75|||||TWO_SIDED|95.0|-1.29|-0.21||||||||-0.21|-1.29|
70929522|NCT05838027|141355876|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|0.57|||||TWO_SIDED|95.0|-1.9|3.03||||||||3.03|-1.90|
70929523|NCT05838027|141355877|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|0.13|||||TWO_SIDED|95.0|-0.32|0.58||||||||0.58|-0.32|
71048616|NCT00311311|141605772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.546|TWO_SIDED|95.0|-0.33|0.62||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|LDL 36 Months Post-transplant||0.62|-0.33|0.5460
71048617|NCT00311311|141605772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.7511|TWO_SIDED|95.0|-0.12|0.16||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|HDL 36 Months Post-transplant||0.16|-0.12|0.7511
71048618|NCT00311311|141605772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.0048|TWO_SIDED|95.0|0.2|1.06||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|Tg 36 Months Post-transplant||1.06|0.20|0.0048
70929524|NCT05838027|141355878|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|IRR|0.62|||||TWO_SIDED|95.0|0.23|1.63||||||||1.63|0.23|
70929525|NCT05838027|141355879|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|1.05|||||TWO_SIDED|95.0|-0.54|2.64||||||||2.64|-0.54|
70941534|NCT03722485|141383817|SUPERIORITY|||||||0.292||||||Confounding variables of image capture techniques, image quality and image analysis noted throughout study conduct prohibits any definitive conclusions to be drawn from this analysis.|Regression, Linear|Test of treatment effect using a generalized linear model with treatment arm, baseline values, and clinical site as factors.||||||0.2920
71048619|NCT00311311|141605773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.78||||0.1757|TWO_SIDED|95.0|-0.36|1.91||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||1.91|-0.36|0.1757
71048620|NCT00311311|141605773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94||||0.0509|TWO_SIDED|95.0|0.0|1.89||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||1.89|-0.00|0.0509
71104302|NCT03232567|141715695|SUPERIORITY|||||||0.0063|||||||Fisher Exact|||||||0.0063
71104303|NCT03232567|141715696|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||||||0.4828
71104304|NCT03232567|141715696|SUPERIORITY|||||||0.0996|||||||Fisher Exact|||||||0.0996
71048621|NCT00311311|141605773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.11||||0.0683|TWO_SIDED|95.0|-0.09|2.31||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||2.31|-0.09|0.0683
71048622|NCT00311311|141605774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-37.47||||0.2741|TWO_SIDED|95.0|-105.79|30.85||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||30.85|-105.79|0.2741
71048623|NCT00311311|141605774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.97||||0.4865|TWO_SIDED|95.0|-77.48|37.53||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||37.53|-77.48|0.4865
71048624|NCT00311311|141605774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.48||||0.9339|TWO_SIDED|95.0|-62.54|57.59||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||57.59|-62.54|0.9339
71048625|NCT00311311|141605775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003||||0.4892|TWO_SIDED|95.0|-0.005|0.011||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||0.011|-0.005|0.4892
71048626|NCT00311311|141605775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.006||||0.0514|TWO_SIDED|95.0|0.0|0.012||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|LS mean difference||24 months post-transplant||0.012|-0.000|0.0514
71048627|NCT00311311|141605775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.009||||0.118|TWO_SIDED|95.0|-0.002|0.02||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||0.020|-0.002|0.1180
71048628|NCT00311311|141605776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.56||||0.0016|TWO_SIDED|95.0|2.2|8.93||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||8.93|2.20|0.0016
71048629|NCT00311311|141605776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.91||||0.0091|TWO_SIDED|95.0|1.01|6.8||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||6.80|1.01|0.0091
71048630|NCT00311311|141605776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.25||||0.2468|TWO_SIDED|95.0|-1.6|6.1||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||6.10|-1.60|0.2468
71048631|NCT00311311|141605777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.95||||0.5282|TWO_SIDED|95.0|-2.05|3.94||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||3.94|-2.05|0.5282
71048632|NCT00311311|141605777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.27||||0.5057|TWO_SIDED|95.0|-2.53|5.07||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||5.07|-2.53|0.5057
71048633|NCT00311311|141605777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.59||||0.5701|TWO_SIDED|95.0|-4.0|7.18||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||7.18|-4.00|0.5701
71048634|NCT00311311|141605779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.028|TWO_SIDED|95.0|0.03|0.48||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|||12 months post-transplant||0.48|0.03|0.0280
71048635|NCT00311311|141605779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.019|TWO_SIDED|95.0|0.04|0.48||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|||24 months post-transplant||0.48|0.04|0.0190
70929526|NCT05838027|141355880|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.19|5.49||||||||5.49|0.19|
71048636|NCT00311311|141605779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.1182|TWO_SIDED|95.0|-0.07|0.6||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|||36 months post-transplant||0.60|-0.07|0.1182
71048637|NCT00311311|141605780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.7361|TWO_SIDED|95.0|-2.09|1.49||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||1.49|-2.09|0.7361
71048638|NCT00311311|141605780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.5549|TWO_SIDED|95.0|-2.32|1.26||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||1.26|-2.32|0.5549
71048639|NCT00311311|141605780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76||||0.6058|TWO_SIDED|95.0|-3.69|2.17||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||2.17|-3.69|0.6058
71048640|NCT00311311|141605781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.5902|TWO_SIDED|95.0|-1.63|2.84||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||2.84|-1.63|0.5902
71048641|NCT00311311|141605781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.7536|TWO_SIDED|95.0|-2.68|1.95||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||1.95|-2.68|0.7536
71048642|NCT00311311|141605781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.33||||0.4066|TWO_SIDED|95.0|-4.53|1.86||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||1.86|-4.53|0.4066
71048643|NCT00311311|141605782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.47||||0.3678|TWO_SIDED|95.0|-11.46|30.4||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||30.40|-11.46|0.3678
71048644|NCT00311311|141605782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.72||||0.2179|TWO_SIDED|95.0|-6.53|27.97||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||27.97|-6.53|0.2179
71048645|NCT00311311|141605782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.96||||0.3663|TWO_SIDED|95.0|-14.39|38.32||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||38.32|-14.39|0.3663
71048646|NCT00311311|141605783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.041|TWO_SIDED|95.0|0.0|0.8||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||0.8|0.0|0.0410
71048647|NCT00311311|141605783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.0275|TWO_SIDED|95.0|0.0|0.6||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||0.6|0.0|0.0275
71048648|NCT00311311|141605783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.1841|TWO_SIDED|95.0|-0.1|0.6||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||0.6|-0.1|0.1841
71048649|NCT00311311|141605784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.3||||0.0797|TWO_SIDED|95.0|-108.9|6.3||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|LS mean difference||12 months post-transplant||6.3|-108.9|0.0797
70929527|NCT05838027|141355881|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|-1.1|||||TWO_SIDED|95.0|-2.64|0.43||||||||0.43|-2.64|
70929528|NCT05838027|141355882|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|2.72|||||TWO_SIDED|95.0|-1.35|6.8||||||||6.80|-1.35|
71048650|NCT00311311|141605784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.3||||0.2341|TWO_SIDED|95.0|-88.7|22.2||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|LS mean difference||24 months post-transplant||22.2|-88.7|0.2341
71048651|NCT00311311|141605784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.2||||0.6854|TWO_SIDED|95.0|-90.3|59.8||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||59.8|-90.3|0.6854
71048652|NCT00311311|141605785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-72.8||||0.0002|TWO_SIDED|95.0|-108.6|-36.9||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||-36.9|-108.6|0.0002
71048653|NCT00311311|141605785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-67.6||||0.0017|TWO_SIDED|95.0|-108.5|-26.6||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||-26.6|-108.5|0.0017
71048654|NCT00311311|141605785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-62.3||||0.0293|TWO_SIDED|95.0|-118.2|-6.5||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||-6.5|-118.2|0.0293
71048655|NCT00311311|141605787|SUPERIORITY_OR_OTHER|||||||0.2573|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Lipid-Lowering From Consent to Conversion||||0.2573
71048656|NCT00311311|141605787|SUPERIORITY_OR_OTHER|||||||0.6386|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Lipid-Lowering From Conversion to Month 12||||0.6386
71048657|NCT00311311|141605787|SUPERIORITY_OR_OTHER|||||||0.0709|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Lipid-Lowering From Month 12 to Month 24||||0.0709
71048658|NCT00311311|141605787|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Lipid-Lowering From Month 24 to Month 36||||1.0000
71048659|NCT00311311|141605788|SUPERIORITY_OR_OTHER|||||||0.4286|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Anti-hypertension From Consent to Conversion||||0.4286
71048660|NCT00311311|141605788|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Anti-hypertension From Conversion to Month 12||||1.0000
71048661|NCT00311311|141605788|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Anti-hypertension From Month 12 to Month 24||||1.0000
71048662|NCT00311311|141605788|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Anti-hypertension From Month 24 to Month 36||||1.0000
71048663|NCT00311311|141605789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.0||||0.2718|TWO_SIDED|95.0|-50.7|14.7||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|18 months post-transplant||14.7|-50.7|0.2718
71048664|NCT00311311|141605789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.7||||0.2729|TWO_SIDED|95.0|-41.6|12.1||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|24 months post-transplant||12.1|-41.6|0.2729
71048665|NCT00311311|141605789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2||||0.2902|TWO_SIDED|95.0|-23.8|7.3||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|36 months post-transplant||7.3|-23.8|0.2902
71048666|NCT01610453|141605790|SUPERIORITY_OR_OTHER||||||<|0.01||||||A sample size calculation with alpha 0.05, power 0.8, and cut-off level of HPD at 40 mm. 146 women should be included. The calculation was based from a previous study, in which 93% with HPD ≤40 mm and 57% of with HPD \> 40 mm delivered vaginally.|Chi-squared|||Women were categorized in accordance to fetal descent measured by ultrasound. Head-perineum distance ≤40 mm was used as cut-off level. Vaginal delivery was the primary outcome measure.||||<0.01
71048667|NCT01610453|141605791|SUPERIORITY_OR_OTHER|||||||0.01|||||||Chi-squared|||||||0.01
71048668|NCT00988065|141605792|SUPERIORITY_OR_OTHER||Difference in event rates|0.7||||||95.0|-1.8|3.7|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).|||3.7|-1.8|
71048669|NCT00988065|141605792|SUPERIORITY_OR_OTHER||Difference in event rates|4.7||||||95.0|2.1|9.3|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).|||9.3|2.1|
71048670|NCT00988065|141605793|SUPERIORITY_OR_OTHER||Difference in event rates|0.7||||||95.0|-1.8|3.7|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).|||3.7|-1.8|
71048671|NCT00988065|141605793|SUPERIORITY_OR_OTHER||Difference in event rates|0.0||||||95.0|-2.5|2.5|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).|||2.5|-2.5|
71048672|NCT00988065|141605794|SUPERIORITY_OR_OTHER||Difference in event rates|2.0||||||95.0|-0.5|5.7|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).|Comparison of participants who had Level 1 or Level 2 diagnostic certainty.||5.7|-0.5|
71048673|NCT00988065|141605794|SUPERIORITY_OR_OTHER||Difference in event rates|0.0||||||95.0|-2.5|2.5|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).|Comparison of participants who had Level 1 or Level 2 diagnostic certainty.||2.5|-2.5|
71048674|NCT01229735|141605797|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1|||=|0.7007|TWO_SIDED|95.0|0.7|1.7||P-value is from likelihood ratio test of treatment group regression coefficient against 0.|Regression, Logistic|||The Odds Ratio (OR) for LEV vs TPM is based on logistic regression modeling of subject retention by treatment and center pooling category. A profile likelihood confidence interval for the OR is presented.||1.7|0.7|=0.7007
71048675|NCT00985712|141605828|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.6692|TWO_SIDED|95.0|-0.17|0.26|||Mixed Models Analysis|The model details are given in the section of Measure Description.||Superiority criterion is met if the upper limit of Confidence Interval (CI) is below zero.||0.26|-0.17|0.6692
71048676|NCT00985712|141605829|SUPERIORITY_OR_OTHER|||||||0.3551||95.0||||P-value is for HbA1c ≤7.0%.|Chi-squared|||||||0.3551
71048677|NCT00985712|141605829|SUPERIORITY_OR_OTHER|||||||0.2026||95.0||||P-value is for HbA1c ≤7.5%.|Chi-squared|||||||0.2026
71048678|NCT00985712|141605830|SUPERIORITY_OR_OTHER|||||||0.907||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) was adjusted for baseline values.||||||0.9070
70929529|NCT05838027|141355883|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|-0.69|||||TWO_SIDED|95.0|-1.74|0.36||||||||0.36|-1.74|
70929530|NCT03550170|141355884|NON_INFERIORITY|Non-inferiority was established using the prespecified margin of inferiority of 10 points on the total composite score of the Fatigue Impact Scale.|Slope|4.89|STANDARD_ERROR_OF_MEAN|2.57|||TWO_SIDED|90.0|0.67|9.11|||||Comparison of teleconference to one-to-one at 6 months.|A generalized estimating equation (GEE) served as the primary analysis tool for modeling the longitudinal scores of the primary outcome - Fatigue Impact Scale (FIS).||9.11|0.67|
71048679|NCT00985712|141605831|SUPERIORITY_OR_OTHER|||||||0.9817||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.9817
71048680|NCT00985712|141605832|SUPERIORITY_OR_OTHER|||||||0.1187||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1187
71048681|NCT03123861|141605841|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
71048682|NCT03123861|141605842|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
71048683|NCT03123861|141605843|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
71048684|NCT03123861|141605844|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
71048685|NCT01565616|141605859|OTHER||Mean Difference (Net)|-1.7|STANDARD_DEVIATION|10.4||0.52|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the anxiety domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.52
71048686|NCT01565616|141605859|OTHER||Mean Difference (Net)|2.7|STANDARD_DEVIATION|6.4||0.12|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the depression domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.12
71048687|NCT01565616|141605859|OTHER||Mean Difference (Net)|-1.3|STANDARD_DEVIATION|8.5||0.54|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the fatigue domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.54
71048688|NCT01565616|141605859|OTHER||Mean Difference (Net)|-7.5|STANDARD_DEVIATION|9.3||0.006|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the pain interference domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.006
71048689|NCT01565616|141605859|OTHER||Mean Difference (Net)|5.8|STANDARD_DEVIATION|10.5||0.044|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the physical function domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.044
71048690|NCT01565616|141605859|OTHER||Mean Difference (Net)|0.6|STANDARD_DEVIATION|11.8||0.85|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the satisfaction with social role domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.85
71048691|NCT01565616|141605859|OTHER||Mean Difference (Net)|0.5|STANDARD_DEVIATION|13.5||0.88|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the sleep disturbances domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.88
71048692|NCT01565616|141605859|OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|3.1||0.53|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in raw scores of the pain intensity domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.53
71048693|NCT00321737|141605871|SUPERIORITY_OR_OTHER||||||<|1e-05||||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact|||||||<0.00001
70929531|NCT03550170|141355884|NON_INFERIORITY|Non-inferiority was established using the prespecified margin of inferiority of 10 points on the total composite score of the Fatigue Impact Scale.|Slope|6.12|STANDARD_ERROR_OF_MEAN|2.62|||TWO_SIDED|90.0|0.98|11.26|||||Comparison of internet to one-to-one at 6 months.|A generalized estimating equation (GEE) served as the primary analysis tool for modeling the longitudinal scores of the primary outcome - Fatigue Impact Scale (FIS).||11.26|0.98|
70929532|NCT03550170|141355885|SUPERIORITY|||||||0.1|||||||ANOVA|||||||0.10
70929533|NCT05683340|141355975|SUPERIORITY||Least squares mean difference|-21.78|STANDARD_ERROR_OF_MEAN|2.482||0.001|TWO_SIDED|95.0|-26.71|-16.85|||MMRM||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-16.85|-26.71|0.001
70929534|NCT03687762|141356060|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
70929535|NCT03687762|141356061|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
71048694|NCT00321737|141605871|SUPERIORITY_OR_OTHER||||||<|1e-05||||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact|||||||<0.00001
71048695|NCT00321737|141605871|SUPERIORITY_OR_OTHER||||||>|0.99999||95.0||||Statistical significance was determined at the 0.0025 level without adjustment for multiple comparisons.|Fisher Exact|||||||>0.99999
71048696|NCT00321737|141605872|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparison of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
71048697|NCT00321737|141605872|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparison of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
71048698|NCT00321737|141605872|SUPERIORITY_OR_OTHER|||||||0.0673||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.06730
71048699|NCT00321737|141605874|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank|||||||<0.00001
71048700|NCT00321737|141605874|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank|||||||<0.00001
71048701|NCT00321737|141605874|SUPERIORITY_OR_OTHER|||||||0.13932||95.0||||Statistical significance was determined at the 0.0025 level without adjustment for multiple comparisons.|Log Rank|||||||0.13932
71048702|NCT00321737|141605875|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparison of each dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
71048703|NCT00321737|141605875|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparison of each dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
71048704|NCT00321737|141605875|SUPERIORITY_OR_OTHER|||||||0.11257||95.0||||Statistical significance was determined at the 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.11257
71048705|NCT01769339|141605881|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71048706|NCT00290251|141605883|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|performed on log-transformed delta change in total fibroid volume from baseline to end of treatment||||||0.43
71048707|NCT00290251|141605883|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|95.0|||||ANOVA|Performed on log-transformed delta change||Ulipristal acetate groups one and two were first compared and found to be similar (see statistical analysis 1), so they were combined into a single treatment group for comparison to placebo group||||0.003
70929536|NCT03687762|141356062|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
71048708|NCT00290251|141605884|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|95.0||||The Delta of scores from treatment end to baseline was used to compare by ANOVA.|ANOVA|Adjustment for age||No sample size calculation was made.||||< 0.05
71048709|NCT03188666|141605928|SUPERIORITY||Least Square Mean Difference|-24.6||||0.0741|TWO_SIDED|95.0|-51.8|2.5|||ANCOVA|||||2.5|-51.8|0.0741
71048710|NCT03188666|141605929|SUPERIORITY||Least Square Mean Difference|-24.9||||0.3726|TWO_SIDED|95.0|-80.8|30.9|||Mixed Model with Repeated Measure (MMRM)|||||30.9|-80.8|0.3726
71048711|NCT03188666|141605930|SUPERIORITY|||||||0.0039||||||Week 56 vs. Week 28|Wilcoxon signed rank test|||Compared number of new lesions per participant by CT at week 28 (relative to baseline) and week 56 (relative to week 28).||||0.0039
71048712|NCT03188666|141605931|SUPERIORITY||Least Square Mean Difference|-25.6||||0.0756|TWO_SIDED|95.0|-53.9|2.8|||ANCOVA|||||2.8|-53.9|0.0756
71048713|NCT03188666|141605932|SUPERIORITY||Least Square Mean Difference|-27.8||||0.3407|TWO_SIDED|95.0|-86.1|30.5|||Mixed Model with Repeated Measure (MMRM)|||||30.5|-86.1|0.3407
71048714|NCT03188666|141605933|SUPERIORITY||Least Square Mean Difference|-0.34||||0.2656|TWO_SIDED|95.0|-0.96|0.27|||ANCOVA|||||0.27|-0.96|0.2656
71048715|NCT03188666|141605934|SUPERIORITY||Least Square Mean Difference|-0.36||||0.2651|TWO_SIDED|95.0|-1.01|0.29|||ANCOVA|||||0.29|-1.01|0.2651
71048716|NCT03188666|141605941|SUPERIORITY|||||||0.0039||||||Week 56 vs. Week 28|Wilcoxon signed rank test|||Compared number of new lesions per participant by PET at week 28 (relative to baseline) and week 56 (relative to week 28).||||0.0039
71048717|NCT03188666|141605942|SUPERIORITY|||||||0.0027||||||Week 56 vs. Week 28|McNemar|||Compared percent of participants with new lesions by CT at week 28 (relative to baseline) and week 56 (relative to week 28).||||0.0027
71048718|NCT03188666|141605943|SUPERIORITY|||||||0.0047||||||Week 56 vs. Week 28|McNemar|||Compared percent of participants with new lesions by PET at week 28 (relative to baseline) and week 56 (relative to week 28).||||0.0047
71048719|NCT03188666|141605946|SUPERIORITY|||||||0.3663||||||Period 2 vs. Period 1|Wilcoxon signed rank test|||||||0.3663
71048720|NCT03188666|141605947|SUPERIORITY|||||||0.001||||||Period 2 vs. Period 1|Wilcoxon signed rank test|||||||0.0010
70929537|NCT03687762|141356063|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
70929538|NCT03687762|141356064|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
70929539|NCT03687762|141356065|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.||||||0.01|||||||ANOVA|||||||0.01
70929540|NCT03687762|141356066|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
70929541|NCT03687762|141356067|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
70929542|NCT03687762|141356068|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce a greater proportion of people decreasing their dose relative to those increasing their dose during treatment.|||||>|0.05|||||||Chi-squared|||||||>.05
70929543|NCT03687762|141356069|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
70929544|NCT03687762|141356070|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
70929545|NCT03687762|141356071|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
70929546|NCT03687762|141356072|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
70929547|NCT03687762|141356073|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
70929548|NCT03687762|141356074|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
70929549|NCT03687762|141356075|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
70929550|NCT04820322|141356127|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|||||||0.087
70929551|NCT04820322|141356128|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.020
70929552|NCT04820322|141356129|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
70929553|NCT04820322|141356130|SUPERIORITY|||||||0.7|||||||Fisher Exact|||||||0.70
70929554|NCT04820322|141356131|SUPERIORITY|||||||0.71|||||||Fisher Exact|||||||0.71
70929555|NCT04820322|141356132|SUPERIORITY|||||||0.71|||||||Fisher Exact|||||||0.71
70929556|NCT04820322|141356133|SUPERIORITY|||||||0.67|||||||Fisher Exact|||||||0.67
70929557|NCT04820322|141356134|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
70929558|NCT04820322|141356135|SUPERIORITY|||||||0.023|||||||t-test, 2 sided|||||||0.023
70929559|NCT04820322|141356136|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
70929560|NCT04820322|141356137|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.040
70929561|NCT04200313|141356164|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70929562|NCT04200313|141356164|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70929563|NCT04200313|141356165|NON_INFERIORITY|Non-inferiority with a 1% non-inferiority margin|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70929564|NCT04200313|141356165|NON_INFERIORITY|Non-inferiority with a 1% non-inferiority margin|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70929565|NCT04200313|141356166|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70929566|NCT04200313|141356166|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70929567|NCT04200313|141356167|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70929568|NCT04200313|141356167|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70929569|NCT04200313|141356168|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70929570|NCT04200313|141356168|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70929571|NCT04200313|141356169|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70929572|NCT04200313|141356169|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70929573|NCT04200313|141356170|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70929574|NCT04200313|141356170|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70929575|NCT04200313|141356171|SUPERIORITY|||||||0.51|||||||Mixed Models Analysis|||||||0.51
70929576|NCT04200313|141356171|SUPERIORITY|||||||0.54|||||||Mixed Models Analysis|||||||0.54
70929577|NCT05715528|141356225|SUPERIORITY||Hazard Ratio (HR)|1.099||||0.0681|TWO_SIDED|95.0|0.997|1.211||P-value calculated from stratified Log-rank test with randomization stratification factor as the strata.|Stratified Log-rank test||Hazard ratio and two-sided 95% confidence interval (CI) for hazard ratio were estimated using the Cox regression with randomization stratification factor as a covariate.|||1.211|0.997|0.0681
70929578|NCT05715528|141356229|SUPERIORITY||Hazard Ratio (HR)|1.036||||0.5558|TWO_SIDED|95.0|0.935|1.147|||Stratified Log-Rank Test|P-value calculated from stratified Log-rank test with randomization stratification factor as the strata.|Hazard ratio and two-sided 95% CI for hazard ratio were estimated using the Cox regression with randomization stratification factor as a covariate.|||1.147|0.935|0.5558
70929579|NCT05715528|141356230|SUPERIORITY|||||||0.6469|||||||Fisher's exact test|||||||0.6469
70929580|NCT05715528|141356231|SUPERIORITY||Hazard Ratio (HR)|0.495||||0.5581|TWO_SIDED|95.0|0.045|5.464|||Log-rank test|P value was based on log-rank test.|Hazard ratio and two-sided 95% CI were estimated using the Cox regression.|||5.464|0.045|0.5581
71104305|NCT03232567|141715696|SUPERIORITY|||||||0.0421|||||||Fisher Exact|||||||0.0421
71104306|NCT03232567|141715698|SUPERIORITY|||||||0.0169|||||||Fisher Exact|||NasoVAX low dose vs placebo||||0.0169
71104307|NCT03232567|141715698|SUPERIORITY|||||||0.0063|||||||Fisher Exact|||NasoVAX medium dose vs placebo||||0.0063
71104308|NCT03232567|141715698|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||NasoVAX high dose vs placebo||||<0.0001
71104309|NCT02284893|141715765|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.1001||0.0008|||||||Mixed Models Analysis|||||||0.0008
71104310|NCT02284893|141715766|SUPERIORITY||Risk Difference (RD)|12.2|STANDARD_ERROR_OF_MEAN|4.175||0.0034|||||||Regression, Logistic|the analysis was by Zhang et.al. method with adjustment for baseline A1c.The measure of interest is NOT odds ratio but Risk Difference.||||||0.0034
71104311|NCT02284893|141715767|SUPERIORITY||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|0.2891||0.0001|||||||Mixed Models Analysis|||||||0.0001
71104312|NCT02284893|141715768|SUPERIORITY||Mean Difference (Final Values)|-20.9|STANDARD_ERROR_OF_MEAN|3.682||0.0001|||||||Mixed Models Analysis|||||||0.0001
71104313|NCT02421094|141715781|SUPERIORITY|||||||0.1621|||||||ANCOVA|||||||0.1621
71104314|NCT02421094|141715782|SUPERIORITY|||||||0.9835|||||||ANCOVA|||||||0.9835
71104315|NCT02421094|141715783|SUPERIORITY|||||||0.266|||||||ANCOVA|||||||0.2660
71104316|NCT03126630|141715795|EQUIVALENCE|The null hypothesis that there are no differences between the classes in the population. The purpose of the test is to evaluate how likely the observed frequencies would be assuming the null hypothesis is true.||||||0.27541|||||||Chi-squared|||||||0.27541
71104317|NCT03126630|141715798|SUPERIORITY||Hazard Ratio (HR)|0.0||||0.1936|TWO_SIDED|95.0|0.0||Not enough events||Log Rank||||||0.0|0.1936
71104318|NCT03126630|141715799|SUPERIORITY||Hazard Ratio (HR)|1.81||||0.1952|TWO_SIDED|95.0|0.73|4.51|||Log Rank|||||4.51|0.73|0.1952
71104319|NCT00071032|141715835|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.84|1.22|||||Liberal Arm (numerator) compared to Restrictive Arm (denominator)|||1.22|0.84|
71104320|NCT00071032|141715836|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-0.9|||||TWO_SIDED|99.0|-3.3|1.6|||||Liberal Arm (numerator) compared to Restrictive Arm (denominator)|||1.6|-3.3|
71104321|NCT05078112|141715868|OTHER|||||||0.000393|||||||t-test, 2 sided|||||||0.000393
71104322|NCT02757768|141715906|SUPERIORITY||Least Squares (LS) Mean of Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.19||0.039|TWO_SIDED|95.0|-0.76|-0.02|||ANCOVA|||Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-0.02|-0.76|0.039
71104323|NCT02757768|141715907|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.18||0.558|TWO_SIDED|95.0|-0.46|0.25|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.25|-0.46|0.558
71104324|NCT02757768|141715907|SUPERIORITY||LS Mean of Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.19||0.007|TWO_SIDED|95.0|-0.89|-0.14|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-0.14|-0.89|0.007
71104325|NCT02757768|141715907|SUPERIORITY||LS Mean of Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.19||0.041|TWO_SIDED|95.0|-0.76|-0.02|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-0.02|-0.76|0.041
71104326|NCT02757768|141715908|SUPERIORITY||LS Mean of Difference|3.87|STANDARD_ERROR_OF_MEAN|2.8||0.167|TWO_SIDED|95.0|-1.63|9.37|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||9.37|-1.63|0.167
71104327|NCT02757768|141715908|SUPERIORITY||LS Mean of Difference|6.29|STANDARD_ERROR_OF_MEAN|3.28||0.056|TWO_SIDED|95.0|-0.15|12.73|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||12.73|-0.15|0.056
71104328|NCT02757768|141715908|SUPERIORITY||LS Mean of Difference|8.99|STANDARD_ERROR_OF_MEAN|3.58||0.012|TWO_SIDED|95.0|1.97|16.01|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||16.01|1.97|0.012
71104329|NCT02757768|141715908|SUPERIORITY||LS Mean of Difference|9.25|STANDARD_ERROR_OF_MEAN|3.43||0.007|TWO_SIDED|95.0|2.53|15.98|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||15.98|2.53|0.007
71048721|NCT03188666|141605953|SUPERIORITY|||||||0.0039||||||Week 56 vs. Week 28|Wilcoxon signed rank test|||Compared total new lesion volume per participant by CT at week 28 (relative to baseline) and week 56 (relative to week 28).||||0.0039
71048722|NCT03188666|141605954|SUPERIORITY|||||||0.0273||||||Week 56 vs. Week 28|Wilcoxon signed rank test|||Compared total lesion activity per participant in new lesions by PET at week 28 (relative to baseline) and week 56 (relative to week 28).||||0.0273
71048723|NCT03188666|141605955|SUPERIORITY|||||||0.2123||||||Period 2 vs. Period 1|Wilcoxon signed rank test|||||||0.2123
71048724|NCT03188666|141605956|SUPERIORITY|||||||0.1528||||||Period 2 vs. Period 1|Wilcoxon signed rank test|||||||0.1528
71048725|NCT03696953|141605969|OTHER|t test comparing||||||0.05|||||||t-test, 2 sided|||||||0.05
71048726|NCT03696953|141605970|OTHER|||||||0.73|||||||t-test, 2 sided|||||||0.73
71048727|NCT03696953|141605970|OTHER|T test||||||0.05|||||||t-test, 2 sided|||||||0.05
71048728|NCT03696953|141605971|OTHER|T test||||||0.01|||||||t-test, 2 sided|||Comparison of 36 week AP-GI-SA Scores between probiotic and placebo groups at 36 weeks||||0.01
71048729|NCT03696953|141605972|OTHER|T test||||||0.05|||||||t-test, 2 sided|||||||0.05
71048730|NCT03696953|141605973|OTHER|T test||||||0.05|||||||t-test, 2 sided|||||||0.05
71048731|NCT05104476|141605974|SUPERIORITY||Bayesian Progression Model|0.81|||||TWO_SIDED|95.0|0.56|1.13|||||Reported here is the estimated effect parameter from the Bayesian Progression Model and the associated Credibility Interval for the active arm.|||1.13|0.56|
71104330|NCT02757768|141715909|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.26||0.747|TWO_SIDED|95.0|-0.63|0.38|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.38|-0.63|0.747
70929581|NCT05715528|141356233|SUPERIORITY||Least Squares Mean|0.02||||0.4254|TWO_SIDED|95.0|-0.03|0.08||p-value was from Mixed-effects model repeated measures (MMRM) with baseline viral load and randomization strata as covariates.|MMRM||95% CI was from MMRM with baseline viral load and randomization strata as covariates.|||0.08|-0.03|0.4254
70929582|NCT05715528|141356234|SUPERIORITY||Hazard Ratio (HR)|1.138||||0.0015|TWO_SIDED|95.0|1.032|1.256||P-value calculated from stratified Log-rank test with randomization stratification factor as the strata.|Stratified Log-rank test||Hazard ratio and two-sided 95% CI for hazard ratio were estimated using the Cox regression with randomization stratification factor as a covariate.|||1.256|1.032|0.0015
71048732|NCT06204887|141606011|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
71048733|NCT01383421|141606061|SUPERIORITY||||||<|0.001||||||Statistical significance was set at P = 0.05.|Chi-squared|||||||< 0.001
71048734|NCT01383421|141606063|SUPERIORITY|||||||0.058||||||Statistical significance was set at P = 0.05.|Chi-squared|||||||0.058
70929583|NCT05715528|141356235|SUPERIORITY|||||||0.6978|||||||Fisher's exact test|P-value was from the Fisher's exact test.||||||0.6978
70929584|NCT05715528|141356240|SUPERIORITY|||||||0.5707|||||||Fisher's exact test|P-value was from the Fisher's exact test.||||||0.5707
70929585|NCT04934072|141356316|NON_INFERIORITY|Non-inferiority of FKS518 to US-Prolia was demonstrated if the 90% CI for the difference in mean percent change from baseline to Week 52 in LS-BMD laid entirely above -1.45%.|Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.306|||TWO_SIDED|90.0|-0.05|0.96|||||Difference : FKS518 - US-Prolia|||0.96|-0.05|
71048735|NCT01383421|141606065|SUPERIORITY|||||||0.003||||||Statistical significance was set at P = 0.05.|Chi-squared|||||||0.003
71048736|NCT01383421|141606067|SUPERIORITY||LS Mean Difference|-0.203|STANDARD_ERROR_OF_MEAN|0.092||0.027|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 24||||0.027
71048737|NCT01383421|141606067|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.094||0.006|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 52||||0.006
71048738|NCT01383421|141606067|SUPERIORITY||LS Mean Difference|-0.233|STANDARD_ERROR_OF_MEAN|0.098||0.018|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 78||||0.018
71048739|NCT01383421|141606068|SUPERIORITY||LS Mean Difference|-1.686|STANDARD_ERROR_OF_MEAN|0.893||0.059|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 24||||0.059
71048740|NCT01383421|141606068|SUPERIORITY||LS Mean Difference|-2.697|STANDARD_ERROR_OF_MEAN|0.903||0.003|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 52||||0.003
71048741|NCT01383421|141606068|SUPERIORITY||LS Mean Difference|-2.447|STANDARD_ERROR_OF_MEAN|0.945||0.01|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 78||||0.010
71048742|NCT01383421|141606069|SUPERIORITY||LS Mean Difference|-1.791|STANDARD_ERROR_OF_MEAN|0.788||0.023|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 24||||0.023
71048743|NCT01383421|141606069|SUPERIORITY||LS Mean Difference|-2.549|STANDARD_ERROR_OF_MEAN|0.818||0.002|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 52||||0.002
71048744|NCT01383421|141606069|SUPERIORITY||LS Mean Difference|-2.734|STANDARD_ERROR_OF_MEAN|0.872||0.002|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 78||||0.002
71048745|NCT01383421|141606073|SUPERIORITY||LS Mean Difference|1.333|STANDARD_ERROR_OF_MEAN|2.725||0.625|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI absenteeism||||0.625
71048746|NCT01383421|141606073|SUPERIORITY||LS Mean Difference|-0.824|STANDARD_ERROR_OF_MEAN|2.441||0.736|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI presenteeism||||0.736
70929586|NCT04934072|141356316|OTHER|Non-superiority Analysis: Non-superiority of FKS518 to US-Prolia was demonstrated if the 90% CI for the difference in mean percent change from baseline to Week 52 in LS-BMD laid entirely below 1.45%.|Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.306|||TWO_SIDED|90.0|0.19|1.2|||||Difference : FKS518 - US-Prolia|||1.20|0.19|
71048747|NCT01383421|141606073|SUPERIORITY||LS Mean Difference|1.207|STANDARD_ERROR_OF_MEAN|3.126||0.7|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI overall work impairment||||0.700
70850519|NCT02447302|141189208|SUPERIORITY||MH estimate for difference in percentage|18.9|STANDARD_ERROR_OF_MEAN|9.92|=|0.0282|TWO_SIDED|90.0|2.6|35.3||The analysis was performed using MH method that was adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.|Mantel Haenszel|The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.|MH estimated difference in etrasimod 2 mg from Placebo|The primary comparison in the study was between etrasimod 2 mg versus placebo.||35.3|2.6|= 0.0282
70850520|NCT02447302|141189208|SUPERIORITY||MH estimate for difference in percentage|11.4|STANDARD_ERROR_OF_MEAN|10.14|=|0.1309|TWO_SIDED|90.0|-5.3|28.1||The analysis was performed using MH method that was adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.|Mantel Haenszel|The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.|MH estimated difference in etrasimod 1 mg from Placebo|||28.1|-5.3|= 0.1309
70850521|NCT01901250|141189209|SUPERIORITY_OR_OTHER|||||||0.25|||||||Permutation test|Adjusted for child's gender, caries burden at study entry, surface-years at risk, and study cohort.||||||0.25
70850522|NCT01400880|141189232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.98|STANDARD_DEVIATION|3.28|||TWO_SIDED|95.0|1.7|4.27||||||All subjects were monitored with the electrode sensor, TOCO and IUPC. Measurements were taken with the electrode sensor vs. IUPC and were also taken with TOCO vs. IUPC and those measurements were compared to each other. These results are for TOCO and IUPC. Agreement between TOCO and IUPC. Null hypothesis: the mean peak difference between TOCO and IUPC is equal to 0. Alternative hypothesis: the mean peak difference is not equal to 0.||4.27|1.70|
70850523|NCT01400880|141189232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.95|STANDARD_DEVIATION|2.65|||TWO_SIDED|95.0|2.98|4.92||||||All subjects were monitored with the electrode sensor, TOCO and IUPC. Measurements were taken with the electrode sensor vs. IUPC and were also taken with TOCO vs. IUPC and those measurements were compared to each other. These results are for the electrode sensor and IUPC. Agreement between electrode sensor and IUPC. Null hypothesis: the mean peak difference between TOCO and IUPC is equal to 0. Alternative hypothesis: the mean peak difference is not equal to 0.||4.92|2.98|
70850524|NCT02695420|141189259|SUPERIORITY||Treatment Difference|22.1|STANDARD_ERROR_OF_MEAN|6.3||0.0008|TWO_SIDED|95.0|9.6|34.7|||Repeated Measures Model|||||34.7|9.6|0.0008
70850525|NCT02695420|141189259|SUPERIORITY||Treatment Difference|29.3|STANDARD_ERROR_OF_MEAN|6.5|<|0.0001|TWO_SIDED|95.0|16.3|42.3|||Repeated measures model|||||42.3|16.3|< 0.0001
70850526|NCT02695420|141189259|SUPERIORITY||Treatment Difference|25.5|STANDARD_ERROR_OF_MEAN|6.5||0.0002|TWO_SIDED|95.0|12.6|38.4|||Repeated measures model|||||38.4|12.6|0.0002
70850527|NCT00916929|141189308|SUPERIORITY_OR_OTHER||rate per patient year of follow up|1.5||||||95.0|||||exact method|95% Upper Confidence Limit of objective performance criteria||"For each patient cohort, the hypothesis is formally expressed as follows:~H0: Expected False Positive Rate ≥1.5 per patient-year of follow-up Ha: Expected False Positive Rate \<1.5 per patient-year of follow-up~The null hypothesis is rejected at the 5% significance level if the 95% upper confidence limit (UCL) for expected FPR is less than 1.5 per patient-year of follow-up."||||
70850528|NCT00916929|141189309|SUPERIORITY_OR_OTHER||sensitivity|50.0|STANDARD_ERROR_OF_MEAN|5.0|||ONE_SIDED|95.0|50.0||||exact method|||"For each patient cohort, the hypothesis is formally expressed as follows:~H0: Sensitivity ≤ 50% Ha: Sensitivity \> 50%~The desired outcome was to reject the null hypothesis at the 5% significance level. The null hypothesis is rejected at the 5% significance level if the 95% lower confidence limit (LCL) for sensitivity is greater than 50%."|||50|
70850529|NCT01742286|141189357|OTHER||MTD/RDE|510.0||||||||||||||||||
70850530|NCT01742286|141189357|OTHER||MTD/RDE|500.0||||||||||||||||||
70850531|NCT02633020|141189373|SUPERIORITY||LS Mean Difference|-4.85|STANDARD_ERROR_OF_MEAN|14.7||0.7451|TWO_SIDED|90.0|-30.26|20.56|||ANCOVA|Analysis of covariance (ANCOVA) with baseline % aberrant IELs vs total IELs as a covariate and treatment group as a fixed effect.||||20.56|-30.26|0.7451
70850532|NCT02633020|141189374|SUPERIORITY||LS Mean Difference|-38.22|STANDARD_ERROR_OF_MEAN|27.48||0.1803|TWO_SIDED|95.0|-95.73|19.29|||ANCOVA|ANCOVA model with baseline % aberrant IELs vs intestinal epithelial cells as a covariate and treatment group as a fixed effect.||||19.29|-95.73|0.1803
70850533|NCT02633020|141189375|SUPERIORITY||LS Mean Difference|10.67|STANDARD_ERROR_OF_MEAN|24.0||0.6607|TWO_SIDED|95.0|-38.97|60.31|||ANCOVA|ANCOVA model with baseline VH:CD ratio as a covariate and treatment group as a fixed effect.||||60.31|-38.97|0.6607
70850534|NCT02633020|141189376|SUPERIORITY||Odds Ratio (OR)|1.09||||0.9204|TWO_SIDED|95.0|0.2|6.01|||Regression, Logistic|||||6.01|0.20|0.9204
70850535|NCT02633020|141189377|SUPERIORITY||LS Mean Difference|-12.73|STANDARD_ERROR_OF_MEAN|31.34||0.6885|TWO_SIDED|95.0|-77.57|52.12|||ANCOVA|ANCOVA) model with baseline total IEL counts as a covariate and treatment group as a fixed effect.||||52.12|-77.57|0.6885
70850536|NCT02633020|141189378|SUPERIORITY||Ratio of LS Means|1.17|STANDARD_ERROR_OF_MEAN|0.24||0.4469|TWO_SIDED|95.0|0.77|1.8|||Generalized Linear Mixed Model|Generalized linear mixed model with subject as a random effect and treatment group, time (week) and their interaction as fixed effects.||||1.8|0.77|0.4469
70850537|NCT02633020|141189380|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.19||0.4832|TWO_SIDED|95.0|-0.53|0.26|||Linear mixed effects repeated measures|Linear mixed effects repeated measures model with baseline value, treatment group, time point and time point-by-treatment group as fixed effects.||||0.26|-0.53|0.4832
70850538|NCT02633020|141189381|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.24||0.5561|TWO_SIDED|95.0|-0.64|0.35|||Linear mixed effects repeated measures|Linear mixed effects repeated measures model with baseline value, treatment group, time point and a time point-by-treatment group as fixed effects.||||0.35|-0.64|0.5561
70850539|NCT01136785|141189382|SUPERIORITY_OR_OTHER|||||||0.01|||||||t-test, 2 sided|||two-sided t test for the change from baseline between the treated and untreated groups.||||0.01
71104331|NCT02757768|141715909|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.32||0.393|TWO_SIDED|95.0|-0.72|0.54|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.54|-0.72|0.393
70929587|NCT02997202|141356346|SUPERIORITY||Hazard Ratio (HR)|0.679||||0.0518|TWO_SIDED|95.0|0.459|1.005|||Log Rank|||Stratification factors were conditioning regimen intensity MAC vs RIC/NMA, time from transplant to randomization (30 to 60 days vs 61 to 90 days), and the presence of MRD (present vs absent/unknown) based on the pre-transplant BM aspirate.||1.005|0.459|0.0518
71104332|NCT02757768|141715909|SUPERIORITY||LS Mean of Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.32||0.672|TWO_SIDED|95.0|-0.87|0.38|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.38|-0.87|0.672
71104333|NCT02757768|141715909|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.64|TWO_SIDED|95.0|-0.9|0.3|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.30|-0.90|0.640
71104334|NCT02757768|141715910|SUPERIORITY||LS Mean of Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.21||0.222|TWO_SIDED|95.0|-0.68|0.16|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.16|-0.68|0.222
71104335|NCT02757768|141715910|SUPERIORITY||LS Mean of Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.24||0.003|TWO_SIDED|95.0|-1.18|-0.24|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-0.24|-1.18|0.003
71104336|NCT02757768|141715910|SUPERIORITY||LS Mean of Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.24||0.008|TWO_SIDED|95.0|-1.13|-0.17|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-0.17|-1.13|0.008
71104337|NCT02757768|141715910|SUPERIORITY||LS Mean of Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.23||0.004|TWO_SIDED|95.0|-1.13|-0.21|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-0.21|-1.13|0.004
71104338|NCT02757768|141715911|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.4||0.723|TWO_SIDED|95.0|-0.6|0.9|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.9|-0.6|0.723
71104339|NCT02757768|141715911|SUPERIORITY||LS Mean of Difference|0.2|STANDARD_ERROR_OF_MEAN|0.4||0.7|TWO_SIDED|95.0|-0.7|1.0|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||1.0|-0.7|0.700
70850540|NCT01136785|141189383|SUPERIORITY_OR_OTHER|||||||0.011|||||||2-sided Paired t-test|||comparing pre and post Interstitial Glucose levels in the active CPAP group||||0.011
70850541|NCT01136785|141189384|SUPERIORITY_OR_OTHER|||||||0.071|||||||t-test, 2 sided|||||||0.071
70929588|NCT02997202|141356347|SUPERIORITY||Hazard Ratio (HR)|0.846||||0.4394|TWO_SIDED|95.0|0.554|1.293|||Log Rank|||Stratification factors were conditioning regimen intensity MAC vs RIC/NMA, time from transplant to randomization (30 to 60 days vs 61 to 90 days), and the presence of MRD (present vs absent/unknown) based on the pre-transplant BM aspirate.||1.293|0.554|0.4394
71014124|NCT00634933|141534856|SUPERIORITY_OR_OTHER|||||||0.255|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.255
71104340|NCT02757768|141715911|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.5||0.4|TWO_SIDED|95.0|-1.3|0.5|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.5|-1.3|0.400
71104341|NCT02757768|141715911|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.4||0.812|TWO_SIDED|95.0|-1.0|0.8|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.8|-1.0|0.812
71104342|NCT02757768|141715912|SUPERIORITY||LS Mean of Difference|0.4|STANDARD_ERROR_OF_MEAN|0.3||0.121|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.9|-0.1|0.121
71104343|NCT02757768|141715912|SUPERIORITY||LS Mean of Difference|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.241|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.8|-0.2|0.241
71048748|NCT01383421|141606073|SUPERIORITY||LS Mean Difference|-3.552|STANDARD_ERROR_OF_MEAN|1.561||0.023|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI activity impairment||||0.023
71048749|NCT01383421|141606074|SUPERIORITY||LS Mean Difference|0.38|STANDARD_ERROR_OF_MEAN|2.736||0.89|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI absenteeism||||0.890
71048750|NCT01383421|141606074|SUPERIORITY||LS Mean Difference|-0.527|STANDARD_ERROR_OF_MEAN|2.523||0.835|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI presenteeism||||0.835
71048751|NCT01383421|141606074|SUPERIORITY||LS Mean Difference|-0.471|STANDARD_ERROR_OF_MEAN|3.205||0.883|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI overall work impairment||||0.883
71048752|NCT01383421|141606074|SUPERIORITY||LS Mean Difference|-3.792|STANDARD_ERROR_OF_MEAN|1.611||0.019|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI activity impairment||||0.019
71048753|NCT01383421|141606075|SUPERIORITY||LS Mean Difference|-0.409|STANDARD_ERROR_OF_MEAN|2.548||0.873|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI absenteeism||||0.873
71048754|NCT01383421|141606075|SUPERIORITY||LS Mean Difference|-0.817|STANDARD_ERROR_OF_MEAN|2.598||0.753|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI presenteeism||||0.753
71048755|NCT01383421|141606075|SUPERIORITY||LS Mean Difference|-2.334|STANDARD_ERROR_OF_MEAN|3.159||0.461|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI overall work impairment||||0.461
71048756|NCT01383421|141606075|SUPERIORITY||LS Mean Difference|-5.537|STANDARD_ERROR_OF_MEAN|1.624|<|0.001|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI activity impairment||||<0.001
71048757|NCT01383421|141606076|SUPERIORITY||LS Mean Difference|2.973|STANDARD_ERROR_OF_MEAN|1.245||0.017|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM convenience||||0.017
71048758|NCT01383421|141606076|SUPERIORITY||LS Mean Difference|2.843|STANDARD_ERROR_OF_MEAN|2.042||0.164|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM effectiveness||||0.164
71048759|NCT01383421|141606076|SUPERIORITY||LS Mean Difference|5.473|STANDARD_ERROR_OF_MEAN|1.866||0.003|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM global satisfaction||||0.003
71048760|NCT01383421|141606076|SUPERIORITY||LS Mean Difference|1.705|STANDARD_ERROR_OF_MEAN|1.769||0.335|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM side effects||||0.335
71048761|NCT01383421|141606077|SUPERIORITY||LS Mean Difference|2.728|STANDARD_ERROR_OF_MEAN|1.183||0.021|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM convenience||||0.021
71048762|NCT01383421|141606077|SUPERIORITY||LS Mean Difference|3.124|STANDARD_ERROR_OF_MEAN|1.93||0.106|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM effectiveness||||0.106
71048763|NCT01383421|141606077|SUPERIORITY||LS Mean Difference|5.572|STANDARD_ERROR_OF_MEAN|1.756||0.002|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM global satisfaction||||0.002
71104344|NCT02757768|141715912|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.3||0.843|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.5|-0.6|0.843
71048764|NCT01383421|141606077|SUPERIORITY||LS Mean Difference|1.885|STANDARD_ERROR_OF_MEAN|1.704||0.269|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM side effects||||0.269
71048765|NCT01383421|141606078|SUPERIORITY||LS Mean Difference|2.324|STANDARD_ERROR_OF_MEAN|1.177||0.049|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM convenience||||0.049
71048766|NCT01383421|141606078|SUPERIORITY||LS Mean Difference|4.929|STANDARD_ERROR_OF_MEAN|1.929||0.011|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM effectiveness||||0.011
71048767|NCT01383421|141606078|SUPERIORITY||LS Mean Difference|5.997|STANDARD_ERROR_OF_MEAN|1.775|<|0.001|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM global satisfaction||||<0.001
71014125|NCT00634933|141534856|SUPERIORITY_OR_OTHER|||||||0.105|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.105
71014126|NCT00634933|141534856|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.001
71014127|NCT00634933|141534856|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.019
71014128|NCT00634933|141534856|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.011
71014129|NCT00634933|141534856|SUPERIORITY_OR_OTHER|||||||0.113|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.113
71014130|NCT00634933|141534856|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.002
71014131|NCT00634933|141534856|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.006
71014132|NCT00634933|141534856|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 24: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.034
71014133|NCT00634933|141534856|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 24: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.003
71014134|NCT01049360|141534857|SUPERIORITY_OR_OTHER||Least square mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.156|0.245||Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate|Mixed Models Analysis|||||0.245|0.156|<0.0001
71014135|NCT01049360|141534857|SUPERIORITY_OR_OTHER||Least square mean difference|0.202|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.158|0.245|||Mixed Models Analysis|Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate||||0.245|0.158|<0.0001
71014136|NCT01049360|141534858|SUPERIORITY_OR_OTHER||Least square mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.083|0.181|||Mixed Models Analysis|Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate||||0.181|0.083|<0.0001
71014137|NCT01049360|141534858|SUPERIORITY_OR_OTHER||Least squares mean difference|0.137|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.088|0.185|||Mixed Models Analysis|Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate||||0.185|0.088|<0.0001
71014138|NCT01049360|141534859|SUPERIORITY_OR_OTHER||Least squares mean difference|0.281|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.23|0.333|||Mixed Models Analysis|Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate||||0.333|0.230|<0.0001
71014139|NCT01049360|141534859|SUPERIORITY_OR_OTHER||Least squares mean difference|0.275|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.224|0.325|||Mixed Models Analysis|Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate||||0.325|0.224|<0.0001
71014140|NCT01694849|141534860|SUPERIORITY||Odds Ratio (OR)|1.092||||0.8539|TWO_SIDED|95.0|0.427|2.795||To deal with multiplicity of comparisons, a step-down approach was adopted to control the type I error to 0.05. The contrast GFT120 mg versus placebo was examined first. If not significant the GFT 80mg versus placebo contrast was not examined.|Regression, Logistic|Baseline NAS, Log transformed baseline aspartate aminotransferase and baseline plasminogen activator inhibitor 1 values|Standard error of the estimate|H\_01: OR\_80 less than or equal to 1 versus H\_11 : OR\_80 greater than 1 H\_02: OR\_120 less than or equal to 1 versus H\_12 : OR\_120 greater than 1||2.795|0.427|0.8539
71029207|NCT02809183|141565994|OTHER|Two-group test||||||0.0074||||||The null hypothesis is that the difference between treatment groups (1.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 4 mEq/L = 0.|Fisher Exact|||||||0.0074
71029208|NCT02809183|141565994|OTHER|Two-group test||||||0.0012||||||The null hypothesis is that the difference between treatment groups (3g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 2 mEq/L = 0.|Fisher Exact|||||||0.0012
71029209|NCT02809183|141565994|OTHER|Two-group test||||||0.0032||||||The null hypothesis is that the difference between treatment groups (3g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 3 mEq/L = 0.|Fisher Exact|||||||0.0032
71029210|NCT02809183|141565994|OTHER|Two-group test||||||0.0013||||||The null hypothesis is that the difference between treatment groups (3g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 4 mEq/L = 0.|Fisher Exact|||||||0.0013
71029211|NCT02809183|141565994|OTHER|Two-group test|||||<|0.0001||||||The null hypothesis is that the difference between treatment groups (4.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 2 mEq/L = 0.|Fisher Exact|||||||< 0.0001
71029212|NCT02809183|141565994|OTHER|Two-group test|||||<|0.0001||||||The null hypothesis is that the difference between treatment groups (4.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 3 mEq/L = 0.|Fisher Exact|||||||< 0.0001
71029213|NCT02809183|141565994|OTHER|Two-group test|||||<|0.0006||||||The null hypothesis is that the difference between treatment groups (4.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 4 mEq/L = 0.|Fisher Exact|||||||< 0.0006
71029214|NCT02809183|141565995|OTHER|Single-group test|Group LS mean|3.5|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.7|4.2||The null hypothesis is that the mean change from baseline within the 6g TRC101 QD group = 0 mEq/L.|Mixed Models Analysis|||||4.2|2.7|<0.0001
71029215|NCT02809183|141565996|OTHER|Two-group test|Difference between group LS means|3.7|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|2.6|4.7||The null hypothesis is the difference between treatment groups (6g TRC101 QD - Pooled Placebo) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||4.7|2.6|<0.0001
71048768|NCT01383421|141606078|SUPERIORITY||LS Mean Difference|1.823|STANDARD_ERROR_OF_MEAN|1.657||0.272|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM side effects||||0.272
71048769|NCT01383421|141606079|SUPERIORITY||LS Mean Difference|0.817|STANDARD_ERROR_OF_MEAN|0.572||0.154|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 24||||0.154
71048770|NCT01383421|141606079|SUPERIORITY||LS Mean Difference|0.772|STANDARD_ERROR_OF_MEAN|0.599||0.198|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 52||||0.198
71048771|NCT01383421|141606079|SUPERIORITY||LS Mean Difference|0.884|STANDARD_ERROR_OF_MEAN|0.585||0.131|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 78||||0.131
71048772|NCT01383421|141606083|SUPERIORITY||LS Mean Between Group Change|0.1|STANDARD_ERROR_OF_MEAN|0.0429||0.019|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|P value is from an ANCOVA model adjusting for Baseline.||Necessity||||0.019
71048773|NCT01383421|141606083|SUPERIORITY||LS Mean Between Group Change|0.0|STANDARD_ERROR_OF_MEAN|0.0526||0.56|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|P value is from an ANCOVA model adjusting for Baseline.||Concern||||0.560
71048774|NCT00062010|141606088|SUPERIORITY_OR_OTHER_LEGACY||Overall Response Percentage|8.8|||||TWO_SIDED|90.0|2.4|21.3||||||The study was designed to have adequate (90%) power to distinguish a true response rate of 50% from a null rate of 35% assuming total accrual of 76 patients in two stages. The design mandated that at least 13 objective responses be observed among 34 patients in the first stage in order to continue to the second stage. These were not observed, so the study stopped after the first stage. 90% exact binomial confidence intervals are provided for the response rate.||21.3|2.4|
71048775|NCT02856880|141606091|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|40.18|||<|0.0001|TWO_SIDED|95.0|32.37|47.99||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque Glycolysis for the first named treatment.|||47.99|32.37|<0.0001
70850542|NCT01136785|141189385|SUPERIORITY_OR_OTHER|||||||0.754|||||||two-sided paired t-test|||Plasma cortisol pre and post 1-week of active CPAP||||0.754
71048776|NCT02856880|141606092|SUPERIORITY_OR_OTHER||LS mean difference|26.41|||<|0.0001|TWO_SIDED|95.0|18.94|33.88||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||33.88|18.94|<0.0001
71048777|NCT02856880|141606092|SUPERIORITY_OR_OTHER||LS mean difference|-2.91||||0.4823|TWO_SIDED|95.0|-11.18|5.37||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of glycolysis for the first named treatment.|||5.37|-11.18|0.4823
71048778|NCT02856880|141606092|SUPERIORITY_OR_OTHER||LS mean difference|10.86||||0.0072|TWO_SIDED|95.0|3.13|18.59||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||18.59|3.13|0.0072
71048779|NCT02856880|141606092|SUPERIORITY_OR_OTHER||LS mean difference|13.77||||0.0009|TWO_SIDED|95.0|6.01|21.53||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||21.53|6.01|0.0009
71048780|NCT02856880|141606092|SUPERIORITY_OR_OTHER||LS mean difference|8.44||||0.0286|TWO_SIDED|95.0|0.93|15.95||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||15.95|0.93|0.0286
71104345|NCT02757768|141715912|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.679|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.7|-0.4|0.679
70850543|NCT01136785|141189386|SUPERIORITY_OR_OTHER|||||||0.308|||||||two-sided paired t-test|||comparing pre and post levels in the active CPAP group||||0.308
70850544|NCT01136785|141189387|SUPERIORITY_OR_OTHER|||||||0.036|||||||two-sided paired t-test|||comparing pre and post levels in the active CPAP group||||0.036
70850545|NCT02954172|141189393|EQUIVALENCE|the equivalence margin of the ORR ratio was set at (0.75, 1.33).|Odds Ratio (OR)|0.9|||||TWO_SIDED|90.0|0.756|1.077||||||||1.077|0.756|
70850546|NCT02954172|141189394|EQUIVALENCE|||||||0.7066|||||||Log Rank|||||||0.7066
70850547|NCT02954172|141189395|EQUIVALENCE|||||||0.3497|||||||Log Rank|||||||0.3497
70850548|NCT03818035|141189397|NON_INFERIORITY|One-sided two-group normal approximation Wald Z-test with Mantel-Haenszel stratum weights for 'disease duration' to test for non-inferiority of 100 mg q16w to 100 mg q8w with non-inferiority margin of 10%. Stratified analysis results are reported.|Risk Difference (RD)|-0.6||||0.0013|TWO_SIDED|90.0|-5.7|4.5|||Wald Z-test|||||4.5|-5.7|0.0013
70850549|NCT00982423|141189417|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Comparison between baseline dose of furosemide (3 weeks) versus reduced dose of furosemide (approximately 6 weeks).||||<0.05
71014141|NCT01694849|141534860|SUPERIORITY||Odds Ratio (OR)|0.897||||0.816|TWO_SIDED|95.0|0.361|2.232||To deal with multiplicity of comparisons, a step-down approach was adopted to control the type I error to 0.05. The contrast GFT120 mg versus placebo was examined first. If not significant the GFT 80mg versus placebo contrast was not examined.|Regression, Logistic|Baseline NAS, Log transformed baseline aspartate aminotransferase and baseline plasminogen activator inhibitor 1 values|Standard error of the estimate|H\_01: OR\_80 less than or equal to 1 versus H\_11 : OR\_80 greater than 1 H\_02: OR\_120 less than or equal to 1 versus H\_12 : OR\_120 greater than 1||2.232|0.361|0.8160
70850550|NCT00982423|141189417|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||Comparison between GFR taken at baseline dose Furosemide (3 weeks) versus normal GFR||||<0.05
71029216|NCT02809183|141565997|OTHER|Two-group test|Difference between group LS means|-0.5|STANDARD_ERROR_OF_MEAN|0.6||0.4214|TWO_SIDED|95.0|-1.6|0.7||The null hypothesis is that the difference between treatment groups (3g TRC101 BID - 6g TRC101 QD) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||0.7|-1.6|0.4214
71029217|NCT02809183|141565998|OTHER|Two-group test|||||<|0.0001||||||The null hypothesis is that the difference between treatment groups (6g TRC101 QD - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 2 mEq/L = 0.|Fisher Exact|||||||< 0.0001
71029218|NCT02809183|141565998|OTHER|Two-group test||||||0.0003||||||The null hypothesis is that the difference between treatment groups (6g TRC101 QD - Pooled Placebo) in the proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 3 mEq/L = 0.|Fisher Exact|||||||0.0003
71029219|NCT02809183|141565998|OTHER|Two-group test||||||0.0003||||||The null hypothesis is that the difference between treatment groups (6g TRC101 QD - Pooled Placebo) in the proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 4 mEq/L = 0.|Fisher Exact|||||||0.0003
71029220|NCT02545998|141565999|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||0.510
71029221|NCT02545998|141566000|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
71029222|NCT02545998|141566001|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71029223|NCT02545998|141566002|SUPERIORITY|||||||0.589|||||||Wilcoxon (Mann-Whitney)|||||||0.589
71029224|NCT02545998|141566003|SUPERIORITY|||||||0.471|||||||Wilcoxon (Mann-Whitney)|||||||0.471
71029225|NCT02545998|141566004|SUPERIORITY|||||||0.264|||||||Sign test|||||||0.264
71029226|NCT01430741|141566019|SUPERIORITY_OR_OTHER||||||=|0.04|||||||Mixed Models Analysis|||Compared changes in service intensity among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.||||=.04
71029227|NCT01430741|141566020|SUPERIORITY_OR_OTHER||||||=|0.21|||||||Mixed Models Analysis|||Compared changes in alcohol dependence among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.||||=.21
71029228|NCT01430741|141566020|SUPERIORITY_OR_OTHER||||||=|0.07|||||||Mixed Models Analysis|||Compared changes in drug dependence among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.||||=.07
71029229|NCT01430741|141566021|SUPERIORITY_OR_OTHER||||||=|0.14|||||||Mixed Models Analysis|||Compared mental health inpatient hospitalizations among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.||||=.14
71029230|NCT01430741|141566021|SUPERIORITY_OR_OTHER||||||=|0.19|||||||Mixed Models Analysis|||Compared medical inpatient hospitalizations among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.||||=.19
71029231|NCT01430741|141566022|SUPERIORITY_OR_OTHER||||||=|0.24|||||||Mixed Models Analysis|||Compared changes in mental health emergency department visits among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.||||=.24
71029232|NCT01430741|141566023|SUPERIORITY_OR_OTHER||||||=|0.481|||||||Regression, Cox|||We used Kaplan-Meier survival curves to estimate the extent and timing of negative housing exits over time and Cox proportional hazards regression to assess the relationship between membership in the GTO group and risk of experiencing a negative housing exit, adjusting for a set of relevant covariates.||||=.481
71029233|NCT04567342|141566038|SUPERIORITY||Risk Ratio (RR)|1.08||||0.531|TWO_SIDED|95.0|0.85|1.37|||Regression, Logistic||||Arm 3 vs. Arm 1|1.37|0.85|0.531
71029234|NCT04567342|141566038|SUPERIORITY||Risk Ratio (RR)|0.84||||0.189|TWO_SIDED|95.0|0.65|1.09|||Regression, Logistic||||Arm 2 vs. Arm 1|1.09|0.65|0.189
71029235|NCT04567342|141566038|SUPERIORITY||Risk Ratio (RR)|1.29||||0.054|TWO_SIDED|95.0|0.1|1.66|||Regression, Logistic||||Arm 3 vs. Arm 2|1.66|0.10|0.054
71029236|NCT04567342|141566038|SUPERIORITY||Risk Ratio (RR)|1.05||||0.654|TWO_SIDED|95.0|0.84|1.32|||Regression, Logistic||||Arm 4 vs. Arm 3|1.32|0.84|0.654
71029237|NCT04567342|141566038|SUPERIORITY||Risk Ratio (RR)|1.36||||0.018|TWO_SIDED|95.0|1.05|1.74|||Regression, Logistic||||Arm 4 vs. Arm 2|1.74|1.05|0.018
71029238|NCT04567342|141566038|SUPERIORITY||Risk Ratio (RR)|1.14||||0.283|TWO_SIDED|95.0|0.9|1.44|||Regression, Logistic||||Arm 4 vs. Arm 1|1.44|0.90|0.283
71029239|NCT04567342|141566039|SUPERIORITY||Risk Ratio (RR)|1.93|||<|0.01|TWO_SIDED|95.0|1.42|2.62|||Regression, Logistic||||Arm 3 vs. Arm 1|2.62|1.42|<0.01
71029240|NCT04567342|141566039|SUPERIORITY||Risk Ratio (RR)|0.82||||0.318|TWO_SIDED|95.0|0.56|1.21|||Regression, Logistic||||Arm 2 vs. Arm 1|1.21|0.56|0.318
71029241|NCT04567342|141566039|SUPERIORITY||Risk Ratio (RR)|2.34|||<|0.01|TWO_SIDED|95.0|1.68|3.26|||Regression, Logistic||||Arm 3 vs. Arm 2|3.26|1.68|<0.01
71014142|NCT01694849|141534861|SUPERIORITY||difference in least square mean change|-0.27||||0.225|TWO_SIDED|95.0|-0.75|0.2|||Mixed Models Analysis|Baseline Non-Alcoholic Fatty Liver Disease Activity Score|Standard error of the least squares mean|"H0: difference in least squares (LS) mean change from baseline equal to 0 H1: difference in LS mean change from baseline not equal to 0~Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4"||0.2|-0.75|0.225
71014143|NCT01694849|141534861|SUPERIORITY||Difference in least square mean change|-0.28||||0.254|TWO_SIDED|95.0|-0.76|0.2|||Mixed Models Analysis|Baseline Non-Alcoholic Fatty Liver Disease Activity Score|Standard error of the least squares mean|"H0: difference in least squares (LS) mean change from baseline equal to 0 H1: difference in LS mean change from baseline not equal to 0~Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4"||0.2|-0.76|0.254
71014144|NCT01694849|141534862|SUPERIORITY||Odds Ratio (OR)|1.073||||0.8586|TWO_SIDED|95.0|0.493|2.339|||Regression, Logistic|Baseline Non-Alcoholic Fatty Liver Disease Activity Score.|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||2.339|0.493|0.8586
71014145|NCT01694849|141534862|SUPERIORITY||Odds Ratio (OR)|1.601||||0.2265|TWO_SIDED|95.0|0.747|3.432|||Regression, Logistic|Baseline Non-Alcoholic Fatty Liver Disease Activity Score|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||3.432|0.747|0.2265
71014146|NCT01694849|141534863|SUPERIORITY||Odds Ratio (OR)|0.723||||0.5231|TWO_SIDED|95.0|0.267|1.958|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||1.958|0.267|0.5231
71014147|NCT01694849|141534863|SUPERIORITY||Odds Ratio (OR)|1.102||||0.8459|TWO_SIDED|95.0|0.415|2.924|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||2.924|0.415|0.8459
71014148|NCT01694849|141534864|SUPERIORITY||Odds Ratio (OR)|0.638||||0.5229|TWO_SIDED|95.0|0.161|2.529|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||2.529|0.161|0.5229
71014149|NCT01694849|141534864|SUPERIORITY||Odds Ratio (OR)|1.433||||0.5646|TWO_SIDED|95.0|0.421|4.875|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||4.875|.421|0.5646
71014150|NCT01694849|141534865|SUPERIORITY||Odds Ratio (OR)|0.382||||0.1983|TWO_SIDED|95.0|0.088|1.656|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||1.656|0.088|0.1983
71014151|NCT01694849|141534865|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.288|3.466|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||3.466|0.288|1.0000
71014152|NCT01694849|141534866|SUPERIORITY||Odds Ratio (OR)|0.653||||0.3543|TWO_SIDED|95.0|0.265|1.609|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||1.609|0.265|0.3543
71014153|NCT01694849|141534866|SUPERIORITY||Odds Ratio (OR)|1.27||||0.578|TWO_SIDED|95.0|0.547|2.953|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||2.953|0.547|0.5780
71014154|NCT01694849|141534867|SUPERIORITY||Difference in least square mean change|1.24||||0.711|TWO_SIDED|95.0|-5.33|7.81|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in aspartate transaminase (U/L)||7.81|-5.33|0.711
70850551|NCT00982423|141189422|SUPERIORITY_OR_OTHER|||||||0.075|TWO_SIDED||||||t-test, 2 sided|||Comparison between reduced dose Furosemide and baseline dose Furosemide||||0.075
71014155|NCT01694849|141534867|SUPERIORITY||Difference in least square mean change|-0.94||||0.78|TWO_SIDED|95.0|-7.58|5.7|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in aspartate transaminase (U/L)||5.7|-7.58|0.78
71014156|NCT01694849|141534867|SUPERIORITY||Difference in least square mean change|-6.13||||0.221|TWO_SIDED|95.0|-15.97|3.71|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in alanine aminotransferase (U/L)||3.71|-15.97|0.221
71014157|NCT01694849|141534867|SUPERIORITY||Difference in least square mean change|-9.45||||0.062|TWO_SIDED|95.0|-19.4|0.49|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in alanine aminotransferase (U/L)||0.49|-19.4|0.062
71014158|NCT01694849|141534867|SUPERIORITY||Difference in least square mean change|-23.02|||<|0.001|TWO_SIDED|95.0|-27.16|-18.88|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in Alkaline phosphatases (U/L)||-18.88|-27.16|<0.001
71014159|NCT01694849|141534867|SUPERIORITY||Difference in least square mean change|-23.85|||<|0.001|TWO_SIDED|95.0|-28.04|2.12|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in Alkaline phosphatases (U/L)||2.12|-28.04|<0.001
71014160|NCT01694849|141534867|SUPERIORITY||Difference in least square mean change|-31.41|||<|0.001|TWO_SIDED|95.0|-43.78|-19.05|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in Gamma-glutamyl transferase (U/L)||-19.05|-43.78|<0.001
71014161|NCT01694849|141534867|SUPERIORITY||Difference in least square mean change|-29.31|||<|0.001|TWO_SIDED|95.0|-41.84|-16.77|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in Gamma-glutamyl transferase (U/L)||-16.77|-41.84|<0.001
71014162|NCT01694849|141534868|SUPERIORITY||Difference in least square mean change|0.14|||<|0.001|TWO_SIDED|95.0|0.06|0.21|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.21|0.06|<0.001
71014163|NCT01694849|141534868|SUPERIORITY||Difference in least square mean change|0.19|||<|0.001|TWO_SIDED|95.0|0.11|0.26|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.26|0.11|<0.001
70850552|NCT02712047|141189436|OTHER||Ratio|0.36|||||TWO_SIDED|95.0|0.31|0.43|||||Ratio of FF/VI 100/25mcg versus (Vs) Placebo for Day 1, AM|||0.43|0.31|
70850553|NCT02712047|141189436|OTHER||Ratio|0.33|||||TWO_SIDED|95.0|0.28|0.39|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 1, PM|||0.39|0.28|
71014164|NCT01694849|141534869|SUPERIORITY||Difference in least square mean change|141.78||||0.095|TWO_SIDED|95.0|-24.99|308.55|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||308.55|-24.99|0.095
71014165|NCT01694849|141534869|SUPERIORITY||Difference in least square mean change|-70.57||||0.412|TWO_SIDED|95.0|-239.85|98.71||Baseline parameter value and presence of diabetes as random factors|Mixed Models Analysis||Standard error of the least square mean|||98.71|-239.85|0.412
71014166|NCT01694849|141534870|SUPERIORITY||Difference in least square mean change|32.39||||0.592|TWO_SIDED|95.0|-86.63|151.42|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||151.42|-86.63|0.592
71014167|NCT01694849|141534870|SUPERIORITY||Difference in least square mean change|31.35||||0.61|TWO_SIDED|95.0|-89.42|152.12|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||152.12|-89.42|0.61
71014168|NCT01694849|141534871|SUPERIORITY||Difference in least square mean change|1.67||||0.459|TWO_SIDED|95.0|-2.77|6.11|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||6.11|-2.77|0.459
71014169|NCT01694849|141534871|SUPERIORITY||Difference in least square mean change|-0.67||||0.764|TWO_SIDED|95.0|-5.06|3.72|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||3.72|-5.06|0.764
71014170|NCT01694849|141534872|SUPERIORITY||Difference in least square mean change|-12.92||||0.466|TWO_SIDED|95.0|-47.79|21.95|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||21.95|-47.79|0.466
71014171|NCT01694849|141534872|SUPERIORITY||Difference in least square mean change|-5.82||||0.745|TWO_SIDED|95.0|-41.07|29.42|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||29.42|-41.07|0.745
71014172|NCT01694849|141534873|SUPERIORITY||Difference in least square mean change|-26.57||||0.018|TWO_SIDED|95.0|-48.59|-4.54|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|FG19||-4.54|-48.59|0.018
71014173|NCT01694849|141534873|SUPERIORITY||Difference in least square mean change|-40.39|||<|0.001|TWO_SIDED|95.0|-62.61|-18.17|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|FG19||-18.17|-62.61|<0.001
71014174|NCT01694849|141534873|SUPERIORITY||Difference in least square mean change|190.07||||0.101|TWO_SIDED|95.0|-37.38|417.52|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|FG21||417.52|-37.38|0.101
71014175|NCT01694849|141534873|SUPERIORITY||Difference in least square mean change|228.33||||0.052|TWO_SIDED|95.0|-2.16|458.82|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|FG21||458.82|-2.16|0.052
71014176|NCT01694849|141534874|SUPERIORITY||Difference in least square mean change|-0.14||||0.002|TWO_SIDED|95.0|-0.29|-0.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.01|-0.29|0.002
71014177|NCT01694849|141534874|SUPERIORITY||Difference in least square mean change|-0.24|||<|0.001|TWO_SIDED|95.0|-0.34|-0.15|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.15|-0.34|<0.001
71014178|NCT01694849|141534875|SUPERIORITY||Difference in least square mean change|-16.54||||0.203|TWO_SIDED|95.0|-42.07|8.98|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Hyaluronic acid||8.98|-42.07|0.203
71014179|NCT01694849|141534875|SUPERIORITY||Difference in least square mean change|-6.79||||0.603|TWO_SIDED|95.0|-32.49|18.9|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||18.9|-32.49|0.603
71029242|NCT04567342|141566039|SUPERIORITY||Risk Ratio (RR)|1.08||||0.535|TWO_SIDED|95.0|0.85|1.36|||Regression, Logistic||||Arm 4 vs. Arm 3|1.36|0.85|0.535
71029243|NCT04567342|141566039|SUPERIORITY||Risk Ratio (RR)|2.52|||<|0.01|TWO_SIDED|95.0|1.82|3.5|||Regression, Logistic||||Arm 4 vs Arm 2|3.50|1.82|<0.01
71029244|NCT04567342|141566039|SUPERIORITY||Risk Ratio (RR)|2.07|||<|0.01|TWO_SIDED|95.0|1.53|2.8|||Regression, Logistic||||Arm 4 vs. Arm 1|2.80|1.53|<0.01
71029245|NCT04567342|141566040|SUPERIORITY||Risk Ratio (RR)|1.17||||0.192|TWO_SIDED|95.0|0.92|1.48|||Regression, Logistic||||Arm 3 vs. Arm 1|1.48|0.92|0.192
71029246|NCT04567342|141566040|SUPERIORITY||Risk Ratio (RR)|0.81||||0.132|TWO_SIDED|95.0|0.62|1.06|||Regression, Logistic||||Arm 2 vs. Arm 1|1.06|0.62|0.132
71029247|NCT04567342|141566040|SUPERIORITY||Risk Ratio (RR)|1.44|||<|0.01|TWO_SIDED|95.0|1.11|1.86|||Regression, Logistic||||Arm 3 vs. Arm 2|1.86|1.11|<0.01
71029248|NCT04567342|141566040|SUPERIORITY||Risk Ratio (RR)|0.92||||0.462|TWO_SIDED|95.0|0.73|1.16|||Regression, Logistic||||Arm 4 vs. Arm 3|1.16|0.73|0.462
71029249|NCT04567342|141566040|SUPERIORITY||Risk Ratio (RR)|1.32||||0.039|TWO_SIDED|95.0|1.01|1.72|||Regression, Logistic||||Arm 4 vs. Arm 2|1.72|1.01|0.039
71029250|NCT04567342|141566040|SUPERIORITY||Risk Ratio (RR)|1.07||||0.57|TWO_SIDED|95.0|0.84|1.37|||Regression, Logistic||||Arm 4 vs. Arm 1|1.37|0.84|0.570
71029251|NCT00117949|141566043|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Log Rank|||||||<0.001
71029252|NCT00117949|141566043|SUPERIORITY_OR_OTHER||Median days to insufficient T response|84.0||||||95.0|35.0|112.0||||||Kaplan-Meier estimates of the time to meet insufficient testosterone (T) response.||112|35|
71029253|NCT00117949|141566043|SUPERIORITY_OR_OTHER||Median days to insufficient T response|98.0||||||95.0|70.0|126.0||||||Kaplan-Meier estimates of the time to meet insufficient testosterone (T) response||126|70|
71029254|NCT00117949|141566043|SUPERIORITY_OR_OTHER||Median days to insufficient T response|35.0||||||95.0|14.0|98.0||||||Kaplan-Meier estimates of the time to meet insufficient testosterone (T) response||98|14|
71029255|NCT00117949|141566044|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Log Rank|Participants not castrated were censored as of the days from dosing for the last available observation.||||||0.003
71048781|NCT02856880|141606092|SUPERIORITY_OR_OTHER||LS mean difference|5.32||||0.1573|TWO_SIDED|95.0|-2.15|12.79||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||12.79|-2.15|0.1573
71048782|NCT02856880|141606092|SUPERIORITY_OR_OTHER||LS mean difference|-29.32|||<|0.0001|TWO_SIDED|95.0|-37.2|-21.43||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||-21.43|-37.20|<0.0001
71048783|NCT02856880|141606092|SUPERIORITY_OR_OTHER||LS mean difference|31.74|||<|0.0001|TWO_SIDED|95.0|24.18|39.3||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||39.30|24.18|<0.0001
71048784|NCT02856880|141606092|SUPERIORITY_OR_OTHER||LS mean difference|2.42||||0.5174|TWO_SIDED|95.0|-5.08|9.92||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||9.92|-5.08|0.5174
71048785|NCT02856880|141606093|SUPERIORITY_OR_OTHER||LS mean difference|-233.22|||<|0.0001|TWO_SIDED|95.0|-332.88|-133.55||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||-133.55|-332.88|<0.0001
71048786|NCT02856880|141606093|SUPERIORITY_OR_OTHER||LS mean difference|35.53||||0.5018|TWO_SIDED|95.0|-69.9|140.96||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||140.96|-69.90|0.5018
71048787|NCT02856880|141606093|SUPERIORITY_OR_OTHER||LS mean difference|-24.73||||0.6325|TWO_SIDED|95.0|-128.07|78.61||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||78.61|-128.07|0.6325
71048788|NCT02856880|141606093|SUPERIORITY_OR_OTHER||LS mean difference|-60.26||||0.2427|TWO_SIDED|95.0|-162.72|42.21||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||42.21|-162.72|0.2427
71048789|NCT02856880|141606093|SUPERIORITY_OR_OTHER||LS mean difference|1.05||||0.9834|TWO_SIDED|95.0|-100.5|102.61||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||102.61|-100.50|0.9834
71048790|NCT02856880|141606093|SUPERIORITY_OR_OTHER||LS mean difference|-61.31||||0.2226|TWO_SIDED|95.0|-161.14|38.52||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||38.52|-161.14|0.2226
71048791|NCT02856880|141606093|SUPERIORITY_OR_OTHER||LS mean difference|268.74|||<|0.0001|TWO_SIDED|95.0|165.98|371.51||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is second named treatment(non-SLS negative control) minus first named treatment (SLS negative control) such that a negative difference indicates a greater inhibition of plaque|||371.51|165.98|<0.0001
71048792|NCT02856880|141606093|SUPERIORITY_OR_OTHER||LS mean difference|-293.47|||<|0.0001|TWO_SIDED|95.0|-396.03|-190.91||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||-190.91|-396.03|<0.0001
71048793|NCT02856880|141606093|SUPERIORITY_OR_OTHER||LS mean difference|-294.53|||<|0.0001|TWO_SIDED|95.0|-395.43|-193.62||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||-193.62|-395.43|<0.0001
71048794|NCT02856880|141606093|SUPERIORITY_OR_OTHER||LS mean difference|-25.78||||0.6086|TWO_SIDED|95.0|-126.53|74.96||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||74.96|-126.53|0.6086
71048795|NCT02856880|141606094|SUPERIORITY_OR_OTHER||LS mean difference|-273.92||||0.6664|TWO_SIDED|95.0|-1550.45|1002.61||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||1002.61|-1550.45|0.6664
71048796|NCT02856880|141606094|SUPERIORITY_OR_OTHER||LS mean difference|674.06||||0.3249|TWO_SIDED|95.0|-692.21|2040.33||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||2040.33|-692.21|0.3249
71048797|NCT02856880|141606094|SUPERIORITY_OR_OTHER||LS mean difference|677.09||||0.3544|TWO_SIDED|95.0|-784.16|2138.35||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||2138.35|-784.16|0.3544
71048798|NCT02856880|141606094|SUPERIORITY_OR_OTHER||LS mean difference|3.04||||0.9967|TWO_SIDED|95.0|-1469.45|1475.52||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||1475.52|-1469.45|0.9967
71048799|NCT02856880|141606094|SUPERIORITY_OR_OTHER||LS mean difference|766.64||||0.2976|TWO_SIDED|95.0|-703.26|2236.54||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||2236.54|-703.26|0.2976
71048800|NCT02856880|141606094|SUPERIORITY_OR_OTHER||LS mean difference|-763.6||||0.2702|TWO_SIDED|95.0|-2144.45|617.25||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||617.25|-2144.45|0.2702
71048801|NCT02856880|141606094|SUPERIORITY_OR_OTHER||LS mean difference|947.97||||0.1511|TWO_SIDED|95.0|-361.95|2257.9||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||2257.90|-361.95|0.1511
71048802|NCT02856880|141606094|SUPERIORITY_OR_OTHER||LS mean difference|-270.88||||0.6998|TWO_SIDED|95.0|-1680.58|1138.82||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||1138.82|-1680.58|0.6998
71048803|NCT02856880|141606094|SUPERIORITY_OR_OTHER||LS mean difference|-1037.52||||0.121|TWO_SIDED|95.0|-2361.33|286.29||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant -level pre-treatment values and period minus participant -level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||286.29|-2361.33|0.1210
71048804|NCT02856880|141606094|SUPERIORITY_OR_OTHER||LS mean difference|-89.54||||0.8935|TWO_SIDED|95.0|-1439.5|1260.41||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||1260.41|-1439.50|0.8935
71048805|NCT02944383|141606098|SUPERIORITY||Median Difference (Net)|-19.02||||0.0063|TWO_SIDED|95.0|-33.07|-4.25|||Ranked ANCOVA|Randomized treatment group \& randomized baseline statin (yes or no) are included as factors, \& outcome (ranked) at baseline is included as covariate.|Estimates generated from Hodges-Lehmann method.|||-4.25|-33.07|0.0063
70850554|NCT02712047|141189436|OTHER||Ratio|0.38|||||TWO_SIDED|95.0|0.32|0.45|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 2, AM|||0.45|0.32|
70929589|NCT02997202|141356350|SUPERIORITY||Hazard Ratio (HR)|2.308||||0.0209|TWO_SIDED|95.0|1.1352|4.6922|||Fine-Grays Model|||Based on Fine \& Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate.||4.6922|1.1352|0.0209
71014180|NCT01694849|141534875|SUPERIORITY||Difference in least square mean change|-0.73||||0.235|TWO_SIDED|95.0|-1.95|0.48|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|PIIINP||0.48|-1.95|0.235
71048806|NCT02944383|141606098|SUPERIORITY||Median Difference (Net)|-7.63||||0.235|TWO_SIDED|95.0|-25.88|7.05|||Ranked ANCOVA|Randomized treatment group \& randomized baseline statin (yes or no) are included as factors, \& outcome (ranked) at baseline is included as covariate.|Estimates generated from Hodges-Lehmann method.|||7.05|-25.88|0.2350
71048807|NCT02944383|141606099|OTHER|||||||0.1663||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.1663
71048808|NCT02944383|141606099|SUPERIORITY|||||||0.6195||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.6195
71048809|NCT02944383|141606099|SUPERIORITY|||||||0.0436||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.0436
71048810|NCT02944383|141606099|SUPERIORITY|||||||0.5||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.5000
71048811|NCT02944383|141606099|SUPERIORITY|||||||0.0007||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0007
71048812|NCT02944383|141606099|SUPERIORITY|||||||0.1161||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1161
71048813|NCT02944383|141606099|SUPERIORITY|||||||0.183||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1830
70929590|NCT02997202|141356351|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.6417|TWO_SIDED|95.0|0.686|1.261|||Log Rank|||Stratification factors were conditioning regimen intensity MAC vs RIC/NMA, time from transplant to randomization (30 to 60 days vs 61 to 90 days), and the presence of MRD (present vs absent/unknown) based on the pre-transplant BM aspirate.||1.261|0.686|0.6417
70850555|NCT02712047|141189436|OTHER||Ratio|0.37|||||TWO_SIDED|95.0|0.31|0.44|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 2, PM|||0.44|0.31|
71048814|NCT02944383|141606099|SUPERIORITY|||||||0.8762||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.8762
71048815|NCT02944383|141606100|SUPERIORITY|||||||0.178||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.1780
71048816|NCT02944383|141606100|SUPERIORITY|||||||0.7615||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.7615
71048817|NCT02944383|141606100|SUPERIORITY|||||||0.0162||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.0162
71048818|NCT02944383|141606100|SUPERIORITY|||||||0.371||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.3710
71048819|NCT02944383|141606100|SUPERIORITY|||||||0.001||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0010
71048820|NCT02944383|141606100|SUPERIORITY|||||||0.0988||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0988
70929591|NCT02997202|141356352|SUPERIORITY||Hazard Ratio (HR)|0.8938||||0.641|TWO_SIDED|95.0|0.5574|1.433|||Fine-Grays model|||"aGVHD II to IV:~Based on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate."||1.4330|0.5574|0.6410
71014181|NCT01694849|141534875|SUPERIORITY||Difference in least square mean change|-0.81||||0.193|TWO_SIDED|95.0|-2.04|0.41|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|PIIINP||0.41|-2.04|0.193
71014182|NCT01694849|141534875|SUPERIORITY||Difference in least square mean change|6.21||||0.348|TWO_SIDED|95.0|-6.81|19.22|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|TIMP-1||19.22|-6.81|0.348
70929592|NCT02997202|141356352|SUPERIORITY||Hazard Ratio (HR)|1.4254||||0.4128|TWO_SIDED|95.0|0.6103|3.3289|||Fine-Grays model|||"aGVHD III to IV:~Based on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate."||3.3289|0.6103|0.4128
70929593|NCT02997202|141356353|SUPERIORITY||Hazard Ratio (HR)|1.236||||0.1725|TWO_SIDED|95.0|0.9116|1.6757|||Fine-Grays Model|||Based on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate.||1.6757|0.9116|0.1725
70929594|NCT02997202|141356354|SUPERIORITY||Hazard Ratio (HR)|1.236||||0.1725|TWO_SIDED|95.0|0.9116|1.6757|||Fine-Grays Model|||Based on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate.||1.6757|0.9116|0.1725
71048821|NCT02944383|141606100|SUPERIORITY|||||||0.2594||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2594
71014183|NCT01694849|141534875|SUPERIORITY||Difference in least square mean change|-14.66||||0.029|TWO_SIDED|95.0|-27.81|1.51|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|TIMP-1||1.51|-27.81|0.029
71014184|NCT01694849|141534876|SUPERIORITY||Difference in least square mean change|-0.05|||<|0.001|TWO_SIDED|95.0|-0.07|-0.02|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.02|-0.07|<0.001
71014185|NCT01694849|141534876|SUPERIORITY||Difference in least square mean change|-0.05|||<|0.001|TWO_SIDED|95.0|-0.08|-0.02|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.02|-0.08|<0.001
71014186|NCT01694849|141534877|SUPERIORITY||Difference in least square mean change|-0.11|||<|0.001|TWO_SIDED|95.0|-0.15|-0.07|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.07|-0.15|<0.001
71014187|NCT01694849|141534877|SUPERIORITY||Difference in least square mean change|-0.11|||<|0.001|TWO_SIDED|95.0|-0.15|-0.07|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.07|-0.15|<0.001
71014188|NCT01694849|141534878|SUPERIORITY||Difference in least square mean change|0.06||||0.471|TWO_SIDED|95.0|-0.11|0.23|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.23|-0.11|0.471
71014189|NCT01694849|141534878|SUPERIORITY||Difference in least square mean change|-0.25||||0.005|TWO_SIDED|95.0|-0.42|-0.08|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.08|-0.42|0.005
71014190|NCT01694849|141534879|SUPERIORITY||Difference in least square mean change|-0.07||||0.457|TWO_SIDED|95.0|-0.27|0.12|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.12|-0.27|0.457
71014191|NCT01694849|141534879|SUPERIORITY||Difference in least square mean|-0.08||||0.428|TWO_SIDED|95.0|-0.28|0.12|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.12|-0.28|0.428
71014192|NCT01694849|141534880|SUPERIORITY||Difference in least square mean change|-9.22|||<|0.001|TWO_SIDED|95.0|-13.19|-5.24|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-5.24|-13.19|<0.001
71048822|NCT02944383|141606100|SUPERIORITY|||||||0.9099||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.9099
71014193|NCT01694849|141534880|SUPERIORITY||Difference in least square mean change|-9.08|||<|0.001|TWO_SIDED|95.0|-13.12|-5.04|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-5.04|-13.12|<0.001
71014194|NCT01694849|141534881|SUPERIORITY||Difference in least square mean change|0.02||||0.531|TWO_SIDED|95.0|-0.05|0.09|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.09|-0.05|0.531
70929595|NCT02997202|141356355|SUPERIORITY||Hazard Ratio (HR)|3.4537||||0.2029|TWO_SIDED|95.0|0.5126|23.2687|||Fine-Grays Model|||MRD Eradication||23.2687|0.5126|0.2029
70929596|NCT02997202|141356355|SUPERIORITY||Hazard Ratio (HR)|0.7073||||0.4077|TWO_SIDED|95.0|0.3116|1.6055|||Fine-Grays Model|||MRD 10\^-4 Detection||1.6055|0.3116|0.4077
71014195|NCT01694849|141534881|SUPERIORITY||Difference in least square mean change|-0.02||||0.638|TWO_SIDED|95.0|-0.08|0.05|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.05|-0.08|0.638
71014196|NCT01694849|141534882|SUPERIORITY||Difference in least square mean change|-0.14||||0.831|TWO_SIDED|95.0|-1.39|1.12|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Total bilirubin||1.12|-1.39|0.831
71014197|NCT01694849|141534882|SUPERIORITY||Difference in least square mean change|0.2||||0.754|TWO_SIDED|95.0|-1.07|1.47|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Total bilirubin||1.47|-1.07|0.754
71014198|NCT01694849|141534882|SUPERIORITY||Difference in least square mean change|-0.03||||0.848|TWO_SIDED|95.0|-0.36|0.3|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Conjugated Bilirubin||0.3|-0.36|0.848
71014199|NCT01694849|141534882|SUPERIORITY||Difference in least square mean change|0.11||||0.511|TWO_SIDED|95.0|-0.22|0.45|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Conjugated Bilirubin||0.45|-0.22|0.511
71014200|NCT01694849|141534883|SUPERIORITY||Difference in least square mean change|-2.83||||0.075|TWO_SIDED|95.0|-5.95|0.29|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.29|-5.95|0.075
71048823|NCT02944383|141606100|SUPERIORITY|||||||0.0219||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0219
71048824|NCT02944383|141606100|SUPERIORITY|||||||0.3494||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.3494
71014201|NCT01694849|141534883|SUPERIORITY||Difference in least square mean change|-1.11||||0.491|TWO_SIDED|95.0|-4.29|2.07|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||2.07|-4.29|0.491
71048825|NCT02944383|141606101|SUPERIORITY|||||||0.0391||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.0391
71048826|NCT02944383|141606101|SUPERIORITY|||||||0.2455||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.2455
71048827|NCT02944383|141606101|SUPERIORITY|||||||0.026||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.0260
71048828|NCT02944383|141606101|SUPERIORITY|||||||0.5704||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.5704
71048829|NCT02944383|141606101|SUPERIORITY|||||||0.0009||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0009
71048830|NCT02944383|141606101|SUPERIORITY|||||||0.0846||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0846
71048831|NCT02944383|141606101|SUPERIORITY|||||||0.1763||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1763
71048832|NCT02944383|141606101|SUPERIORITY|||||||0.5576||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.5576
71048833|NCT02944383|141606101|SUPERIORITY||Median Difference (Net)|-14.66||||0.0086|TWO_SIDED|95.0|-24.68|-4.39||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-4.39|-24.68|0.0086
71014202|NCT01694849|141534884|SUPERIORITY||Difference in least square mean change|-0.03||||0.393|TWO_SIDED|95.0|-0.1|0.04|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.04|-0.1|0.393
71048834|NCT02944383|141606101|SUPERIORITY||Mean Difference (Net)|-5.06||||0.1516|TWO_SIDED|95.0|-15.02|3.64||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||3.64|-15.02|0.1516
71014203|NCT01694849|141534884|SUPERIORITY||Difference in least square mean change|-0.04||||0.289|TWO_SIDED|95.0|-0.11|0.03|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.03|-0.11|0.289
71014204|NCT01694849|141534885|SUPERIORITY||Difference in least square mean change|-0.47|||<|0.001|TWO_SIDED|95.0|-0.73|-0.21|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Triglycerides||-0.21|-0.73|<0.001
71048835|NCT02944383|141606102|SUPERIORITY|||||||0.0386||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.0386
71048836|NCT02944383|141606102|SUPERIORITY|||||||0.1206||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.1206
71048837|NCT02944383|141606102|SUPERIORITY|||||||0.0364||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.0364
71048838|NCT02944383|141606102|SUPERIORITY|||||||0.4312||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.4312
71048839|NCT02944383|141606102|SUPERIORITY|||||||0.001||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0010
71048840|NCT02944383|141606102|SUPERIORITY|||||||0.0407||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0407
71048841|NCT02944383|141606102|SUPERIORITY|||||||0.1433||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1433
71048842|NCT02944383|141606102|SUPERIORITY|||||||0.2866||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2866
71048843|NCT02944383|141606102|SUPERIORITY|||||||0.0056||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0056
71048844|NCT02944383|141606102|SUPERIORITY|||||||0.0789||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0789
71048845|NCT02944383|141606103|SUPERIORITY|||||||0.0277||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.0277
71048846|NCT02944383|141606103|SUPERIORITY|||||||0.2502||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.2502
71048847|NCT02944383|141606103|SUPERIORITY|||||||0.0161||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.0161
71048848|NCT02944383|141606103|SUPERIORITY|||||||0.6567||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.6567
71048849|NCT02944383|141606103|SUPERIORITY|||||||0.001||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0010
71104346|NCT02757768|141715913|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.175|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.7|0.175
71104347|NCT02757768|141715913|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.43|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.2|-0.6|0.430
71048850|NCT02944383|141606103|SUPERIORITY|||||||0.1257||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1257
71048851|NCT02944383|141606103|SUPERIORITY|||||||0.144||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1440
71048852|NCT02944383|141606103|SUPERIORITY|||||||0.7642||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7642
71048853|NCT02944383|141606103|SUPERIORITY||Median Difference (Net)|-16.4||||0.0107|TWO_SIDED|95.0|-28.31|-4.51||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-4.51|-28.31|0.0107
71048854|NCT02944383|141606103|SUPERIORITY||Median Difference (Net)|-5.32||||0.2466|TWO_SIDED|95.0|-16.73|5.52||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||5.52|-16.73|0.2466
71048855|NCT02944383|141606104|SUPERIORITY|||||||0.0211||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.0211
71048856|NCT02944383|141606104|SUPERIORITY|||||||0.1304||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.1304
71104348|NCT02757768|141715913|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.141|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.8|0.141
71104349|NCT02757768|141715913|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.288|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.2|-0.7|0.288
70850556|NCT02712047|141189436|OTHER||Ratio|0.46|||||TWO_SIDED|95.0|0.39|0.54|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 3, AM|||0.54|0.39|
71048857|NCT02944383|141606104|SUPERIORITY|||||||0.0318||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.0318
71048858|NCT02944383|141606104|SUPERIORITY|||||||0.4607||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.4607
71048859|NCT02944383|141606104|SUPERIORITY|||||||0.0012||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0012
71048860|NCT02944383|141606104|SUPERIORITY|||||||0.0592||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0592
71048861|NCT02944383|141606104|SUPERIORITY|||||||0.117||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1170
71048862|NCT02944383|141606104|SUPERIORITY|||||||0.3138||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3138
71048863|NCT02944383|141606104|SUPERIORITY|||||||0.009||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0090
71048864|NCT02944383|141606104|SUPERIORITY|||||||0.1317||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.1317
71048865|NCT02944383|141606105|SUPERIORITY|||||||0.2395||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.2395
71048866|NCT02944383|141606105|SUPERIORITY|||||||0.638||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.6380
71048867|NCT02944383|141606105|SUPERIORITY|||||||0.7468||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.7468
71048868|NCT02944383|141606105|SUPERIORITY|||||||0.8483||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.8483
71048869|NCT02944383|141606105|SUPERIORITY|||||||0.0008||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0008
71048870|NCT02944383|141606105|SUPERIORITY|||||||0.0938||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0938
71048871|NCT02944383|141606105|SUPERIORITY|||||||0.3201||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3201
71048872|NCT02944383|141606105|SUPERIORITY|||||||0.901||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.9010
71048873|NCT02944383|141606105|SUPERIORITY||Median Difference (Net)|-19.31||||0.0156|TWO_SIDED|95.0|-39.06|-1.49||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-1.49|-39.06|0.0156
71048874|NCT02944383|141606105|SUPERIORITY||Median Difference (Net)|-5.98||||0.3456|TWO_SIDED|95.0|-28.51|17.26||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||17.26|-28.51|0.3456
71048875|NCT02944383|141606106|SUPERIORITY|||||||0.3714||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.3714
71048876|NCT02944383|141606106|SUPERIORITY|||||||0.4415||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.4415
71048877|NCT02944383|141606106|SUPERIORITY|||||||0.7902||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.7902
71048878|NCT02944383|141606106|SUPERIORITY|||||||0.6999||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.6999
71048879|NCT02944383|141606106|SUPERIORITY|||||||0.0015||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0015
71048880|NCT02944383|141606106|SUPERIORITY|||||||0.0796||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0796
71048881|NCT02944383|141606106|SUPERIORITY|||||||0.4225||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4225
71048882|NCT02944383|141606106|SUPERIORITY|||||||0.7687||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7687
71048883|NCT02944383|141606106|SUPERIORITY|||||||0.0437||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0437
71048884|NCT02944383|141606106|SUPERIORITY|||||||0.2735||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.2735
71048885|NCT02944383|141606107|SUPERIORITY|||||||0.1042||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.1042
71048886|NCT02944383|141606107|SUPERIORITY|||||||0.6204||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.6204
71048887|NCT02944383|141606107|SUPERIORITY|||||||0.8659||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.8659
71048888|NCT02944383|141606107|SUPERIORITY|||||||0.9658||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.9658
71048889|NCT02944383|141606107|SUPERIORITY|||||||0.8238||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.8238
71048890|NCT02944383|141606107|SUPERIORITY|||||||0.4874||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.4874
71048891|NCT02944383|141606107|SUPERIORITY|||||||0.9467||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.9467
71048892|NCT02944383|141606107|SUPERIORITY|||||||0.7467||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7467
71048893|NCT02944383|141606107|SUPERIORITY||Median Difference (Net)|-0.41||||0.9081|TWO_SIDED|95.0|-10.77|10.75||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||10.75|-10.77|0.9081
71048894|NCT02944383|141606107|SUPERIORITY||Median Difference (Net)|-2.38||||0.548|TWO_SIDED|95.0|-11.82|6.86||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||6.86|-11.82|0.5480
71048895|NCT02944383|141606108|SUPERIORITY|||||||0.1485||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.1485
71048896|NCT02944383|141606108|SUPERIORITY|||||||0.6008||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.6008
71048897|NCT02944383|141606108|SUPERIORITY|||||||0.9409||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.9409
71048898|NCT02944383|141606108|SUPERIORITY|||||||0.9292||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.9292
71048899|NCT02944383|141606108|SUPERIORITY|||||||0.8455||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.8455
71048900|NCT02944383|141606108|SUPERIORITY|||||||0.5256||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.5256
71048901|NCT02944383|141606108|SUPERIORITY|||||||0.9217||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.9217
71048902|NCT02944383|141606108|SUPERIORITY|||||||0.7401||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7401
71048903|NCT02944383|141606108|SUPERIORITY|||||||0.9386||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.9386
71048904|NCT02944383|141606108|SUPERIORITY|||||||0.6352||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.6352
71048905|NCT02944383|141606109|SUPERIORITY|||||||0.0165||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0165
71048906|NCT02944383|141606109|SUPERIORITY|||||||0.3075||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.3075
71048907|NCT02944383|141606109|SUPERIORITY|||||||0.1069||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1069
71048908|NCT02944383|141606109|SUPERIORITY|||||||0.6101||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.6101
71048909|NCT02944383|141606109|SUPERIORITY||Median Difference (Net)|-12.04||||0.0351|TWO_SIDED|95.0|-23.79|-1.08||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-1.08|-23.79|0.0351
71048910|NCT02944383|141606109|SUPERIORITY||Median Difference (Net)|-3.15||||0.3746|TWO_SIDED|95.0|-9.86|4.25||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||4.25|-9.86|0.3746
71048911|NCT02944383|141606110|SUPERIORITY|||||||0.0133||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0133
71048912|NCT02944383|141606110|SUPERIORITY|||||||0.2044||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.2044
71048913|NCT02944383|141606110|SUPERIORITY|||||||0.0855||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0855
71048914|NCT02944383|141606110|SUPERIORITY|||||||0.5114||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.5114
71048915|NCT02944383|141606110|SUPERIORITY|||||||0.0289||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0289
71048916|NCT02944383|141606110|SUPERIORITY|||||||0.295||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.2950
70929597|NCT02997202|141356356|SUPERIORITY||Hazard Ratio (HR)|0.3729|||<|0.001|TWO_SIDED|95.0|0.2243|0.6199|||Fine-Grays Model|||Based on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate.||0.6199|0.2243|<0.001
70929598|NCT02997202|141356357|SUPERIORITY||Hazard Ratio (HR)|1.4848||||0.0568|TWO_SIDED|95.0|0.9886|2.23|||Fine-Grays model|||Based on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate.||2.2300|0.9886|0.0568
70929599|NCT04271046|141356368|OTHER|||||||0.97|||||||Regression, Linear|||||||0.97
70929600|NCT04271046|141356369|OTHER|||||||0.55|||||||Regression, Linear|||||||0.55
71014205|NCT01694849|141534885|SUPERIORITY||Difference in least square mean change|-0.55|||<|0.001|TWO_SIDED|95.0|-0.81|-0.29|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Triglycerides||-0.29|-0.81|<0.001
71014206|NCT01694849|141534885|SUPERIORITY||Difference in least square mean change|-0.35||||0.001|TWO_SIDED|95.0|-0.56|-0.14|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Cholesterol||-0.14|-0.56|0.001
70850557|NCT02712047|141189436|OTHER||Ratio|0.47|||||TWO_SIDED|95.0|0.4|0.56|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 3, PM|||0.56|0.40|
71029256|NCT00117949|141566044|SUPERIORITY_OR_OTHER||Median time to castration (days)|3.0||||||95.0|3.0|7.0||||||Kaplan-Meier estimates of the median time to testosterone castration.||7|3|
70929601|NCT04271046|141356370|OTHER|||||||0.26|||||||Regression, Linear|||||||0.26
70929602|NCT04271046|141356371|OTHER|||||||0.42|||||||Regression, Linear|||||||0.42
70929603|NCT04271046|141356378|OTHER|||||||0.08|||||||Regression, Linear|||||||0.08
70929604|NCT04271046|141356379|OTHER|||||||0.79|||||||Regression, Linear|||||||0.79
70929605|NCT04271046|141356380|OTHER|||||||0.6|||||||Regression, Linear|||||||0.60
70929606|NCT04271046|141356381|OTHER|||||||0.86|||||||Regression, Linear|||||||0.86
70929607|NCT04271046|141356382|OTHER|||||||0.46|||||||Regression, Linear|||||||0.46
70929608|NCT04271046|141356383|OTHER|||||||0.55|||||||Regression, Linear|||||||0.55
70929609|NCT04271046|141356384|OTHER|||||||0.63|||||||Regression, Linear|||||||0.63
70929610|NCT04271046|141356385|OTHER|||||||0.28|||||||Regression, Linear|||||||0.28
70929611|NCT04271046|141356386|OTHER|||||||0.82|||||||Regression, Linear|||||||0.82
70929612|NCT04271046|141356387|OTHER|||||||0.04|||||||Regression, Linear|||||||0.04
70929613|NCT04271046|141356388|OTHER|||||||0.98|||||||Regression, Linear|||||||0.98
70929614|NCT04271046|141356389|OTHER|||||||0.22|||||||Regression, Linear|||||||0.22
70929615|NCT04271046|141356390|OTHER|||||||0.85|||||||Regression, Linear|||||||0.85
71029257|NCT00117949|141566044|SUPERIORITY_OR_OTHER||Median time to castration (days)|3.0||||||95.0|1.0|3.0||||||Kaplan-Meier estimates of the time to testosterone castration.||3|1|
71029258|NCT00117949|141566045|SUPERIORITY_OR_OTHER||Percentage of participants|0.0||||||95.0|0.0|0.0||||||Kaplan-Meier estimates of the percentage of participants with sufficient testosterone suppression.||0|0|
71029259|NCT00117949|141566045|SUPERIORITY_OR_OTHER||Percentage of participants|42.7||||||95.0|22.0|63.4||||||Kaplan-Meier estimates of the percentage of participants with sufficient testosterone suppression.||63.4|22|
71029260|NCT00117949|141566045|SUPERIORITY_OR_OTHER||Percentage of participants|61.6||||||95.0|41.8|81.3||||||Kaplan-Meier estimates of the percentage of participants with sufficient testosterone suppression.||81.3|41.8|
71029261|NCT00117949|141566045|SUPERIORITY_OR_OTHER||Percentage of participants|35.6||||||95.0|15.8|55.5||||||Kaplan-Meier estimates of the percentage of participants with sufficient testosterone suppression.||55.5|15.8|
71029262|NCT00117949|141566046|SUPERIORITY_OR_OTHER|||||||0.181||95.0|||||Cochran-Armitage Trend Test.|||||||0.181
71029263|NCT00117949|141566046|SUPERIORITY_OR_OTHER||Percentage of participants|10.0||||||95.0|0.3|44.5||||||Kaplan Meier-estimates of the percentage of participants with testostestone serum levels below 0.5 ng/mL for at least 28 days.||44.5|0.3|
71029264|NCT00117949|141566046|SUPERIORITY_OR_OTHER||Percentage of participants|70.8||||||95.0|48.9|87.4||||||Kaplan Meier-estimates of the percentage of participants with testostestone serum levels below 0.5 ng/mL for at least 28 days.||87.4|48.9|
71029265|NCT00117949|141566046|SUPERIORITY_OR_OTHER||Percentage of participants|79.2||||||95.0|57.8|92.9||||||Kaplan Meier-estimates of the percentage of participants with testostestone serum levels below 0.5 ng/mL for at least 28 days.||92.9|57.8|
71029266|NCT00117949|141566046|SUPERIORITY_OR_OTHER||Percentage of participants|54.2||||||95.0|32.8|74.4||||||Kaplan Meier-estimates of the percentage of participants with testostestone serum levels below 0.5 ng/mL for at least 28 days.||74.4|32.8|
71029267|NCT00117949|141566047|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||Log Rank|||||||0.046
71029268|NCT00117949|141566047|SUPERIORITY_OR_OTHER||days|14.0||||||95.0|14.0|28.0||||||Kaplan-Meier estimates of the time (days) to 50% reduction in PSA||28|14|
71029269|NCT00117949|141566047|SUPERIORITY_OR_OTHER||days|14.0||||||95.0|14.0|28.0||||||Kaplan-Meier estimates of the time (days) to 50% reduction in PSA||28|14|
71029270|NCT00117949|141566047|SUPERIORITY_OR_OTHER||days|28.0||||||95.0|14.0|41.0||||||Kaplan-Meier estimates of the time (days) to 50% reduction in PSA||41|14|
71029271|NCT00117949|141566048|SUPERIORITY_OR_OTHER|||||||0.926||95.0|||||Log Rank|||||||0.926
71029272|NCT00117949|141566048|SUPERIORITY_OR_OTHER||days|56.0||||||95.0|35.0|56.0||||||Kaplan-Meier estimates of the time (days) to 90% reduction in PSA.||56|35|
71029273|NCT00117949|141566048|SUPERIORITY_OR_OTHER||days|56.0||||||95.0|35.0|84.0||||||Kaplan-Meier estimates of the time (days) to 90% reduction in PSA.||84|35|
71029274|NCT00117949|141566048|SUPERIORITY_OR_OTHER||days|56.0||||||95.0|35.0|100.0|||||The upper confidence interval limit could not be calculated. For technical reasons it has been entered as 100.|Kaplan-Meier estimates of the time (days) to 90% reduction in PSA.||100|35|
71029275|NCT01226797|141566050|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.5834||||0.6668|TWO_SIDED|95.0|0.1|3.51|||Fisher Exact||Odds-ratio and confidence interval obtained from logistic regression with treatment as fixed effect|||3.51|0.10|0.6668
71029276|NCT01226797|141566051|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.1591||||0.155|TWO_SIDED|95.0|0.01|1.73|||Fisher Exact||Odds-ratio and confidence interval obtained from logistic regression with treatment as fixed effect.|||1.73|0.01|0.1550
71048917|NCT02944383|141606111|SUPERIORITY|||||||0.1992||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1992
71014207|NCT01694849|141534885|SUPERIORITY||Difference in least square mean change|-0.43|||<|0.001|TWO_SIDED|95.0|-0.64|-0.23|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Cholesterol||-0.23|-0.64|<0.001
71048918|NCT02944383|141606111|SUPERIORITY|||||||0.9945||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.9945
71048919|NCT02944383|141606111|SUPERIORITY|||||||0.5139||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.5139
71048920|NCT02944383|141606111|SUPERIORITY|||||||0.8085||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.8085
71014208|NCT01694849|141534885|SUPERIORITY||Difference in least square mean change|-0.46|||<|0.001|TWO_SIDED|95.0|-0.67|-0.24|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Non-high Density Lipoproteins Cholesterol||-0.24|-0.67|<0.001
71014209|NCT01694849|141534885|SUPERIORITY||Difference in least square mean change|-0.54|||<|0.001|TWO_SIDED|95.0|-0.75|-0.32|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Non-high Density Lipoproteins Cholesterol||-0.32|-0.75|<0.001
71014210|NCT01694849|141534885|SUPERIORITY||Difference in least square mean change|0.09||||0.005|TWO_SIDED|95.0|0.03|0.15|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|High Density Lipoproteins Cholesterol||0.15|0.03|0.005
71014211|NCT01694849|141534885|SUPERIORITY||Difference in least square mean change|0.11|||<|0.001|TWO_SIDED|95.0|0.05|0.17|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|High Density Lipoproteins Cholesterol||0.17|0.05|<0.001
71014212|NCT01694849|141534885|SUPERIORITY||Difference in least square mean change|-0.18|||<|0.001|TWO_SIDED|95.0|-0.26|-0.11|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Very Low Density Lipoproteins Cholesterol||-0.11|-0.26|<0.001
71014213|NCT01694849|141534885|SUPERIORITY||Difference in least square mean change|-0.17|||<|0.001|TWO_SIDED|95.0|-0.25|-0.09|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Very Low Density Lipoproteins Cholesterol||-0.09|-0.25|<0.001
71014214|NCT01694849|141534885|SUPERIORITY||Difference in least square mean change|-0.2||||0.031|TWO_SIDED|95.0|-0.38|-0.02|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Low Density Lipoproteins Cholesterol||-0.02|-0.38|0.031
71014215|NCT01694849|141534885|SUPERIORITY||Difference in least square mean change|-0.24||||0.009|TWO_SIDED|95.0|-0.42|-0.06|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Low Density Lipoproteins Cholesterol||-0.06|-0.42|0.009
71014216|NCT01694849|141534886|SUPERIORITY||Difference in least square mean change|5.73||||0.038|TWO_SIDED|95.0|0.31|11.14|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo A1||11.14|0.31|0.038
71014217|NCT01694849|141534886|SUPERIORITY||Difference in least square mean change|7.07||||0.012|TWO_SIDED|95.0|1.59|12.55|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo A1||12.55|1.59|0.012
71014218|NCT01694849|141534886|SUPERIORITY||Difference in least square mean change|-12.41|||<|0.001|TWO_SIDED|95.0|-17.56|-7.25|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo B||-7.25|-17.56|<0.001
71048921|NCT02944383|141606111|SUPERIORITY||Median Difference (Net)|-0.77||||0.7644|TWO_SIDED|95.0|-6.31|4.85||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||4.85|-6.31|0.7644
71048922|NCT02944383|141606111|SUPERIORITY||Mean Difference (Net)|1.33||||0.9499|TWO_SIDED|95.0|-4.34|6.66||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||6.66|-4.34|0.9499
70850558|NCT02712047|141189436|OTHER||Ratio|0.56|||||TWO_SIDED|95.0|0.47|0.66|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 4, AM|||0.66|0.47|
71048923|NCT02944383|141606112|SUPERIORITY|||||||0.1521||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1521
70929616|NCT04271046|141356391|OTHER|||||||0.8|||||||Regression, Linear|||||||0.80
71014219|NCT01694849|141534886|SUPERIORITY||Difference in least square mean change|-9.61|||<|0.001|TWO_SIDED|95.0|-14.81|-4.41|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo B||-4.41|-14.81|<0.001
71014220|NCT01694849|141534886|SUPERIORITY||Difference in least square mean change|3.55|||<|0.001|TWO_SIDED|95.0|2.14|4.96|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo AII||4.96|2.14|<0.001
71014221|NCT01694849|141534886|SUPERIORITY||Difference in least square mean change|6.1|||<|0.001|TWO_SIDED|95.0|4.67|7.53|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo AII||7.53|4.67|<0.001
70929617|NCT00303459|141356393|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.831||||0.2508|TWO_SIDED|97.31|0.582|1.187|||Log Rank|||||1.187|0.582|0.2508
70929618|NCT00303459|141356394|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.963||||0.8385|TWO_SIDED|95.0|0.673|1.38|||Log Rank|||||1.380|0.673|0.8385
70929619|NCT00303459|141356395|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|21.8||||0.0106|TWO_SIDED|95.0|5.9|37.8|||Wilcoxon (Mann-Whitney)|||||37.8|5.9|0.0106
70929620|NCT00303459|141356396|SUPERIORITY_OR_OTHER_LEGACY||Relative risk of improvement|0.98||||1|TWO_SIDED|95.0|0.6|1.61|||Fisher Exact|||||1.61|0.60|1.0000
70929621|NCT00303459|141356397|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.855||||0.4974|TWO_SIDED|95.0|0.544|1.344|||Log Rank|||||1.344|0.544|0.4974
70929622|NCT00303459|141356398|SUPERIORITY_OR_OTHER_LEGACY||Percentage change over placebo|-23.52||||0.0003|TWO_SIDED|95.0|-33.69|-11.79|||Repeated measures analysis|||||-11.79|-33.69|0.0003
71014222|NCT01694849|141534886|SUPERIORITY||Difference in least square mean change|-2.27|||<|0.001|TWO_SIDED|95.0|-3.29|-1.25|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo CIII||-1.25|-3.29|<0.001
71014223|NCT01694849|141534886|SUPERIORITY||Difference in least square mean change|-1.5||||0.004|TWO_SIDED|95.0|-2.52|-0.49|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo CIII||-0.49|-2.52|0.004
71014224|NCT01694849|141534886|SUPERIORITY||Difference in least square mean change|-1.78|||<|0.001|TWO_SIDED|95.0|-2.63|-0.92|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo CIII/B||-0.92|-2.63|<0.001
71014225|NCT01694849|141534886|SUPERIORITY||Difference in least square mean change|-1.15||||0.009|TWO_SIDED|95.0|-2.0|-0.29|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo CIII/B||-0.29|-2|0.009
71014226|NCT01694849|141534886|SUPERIORITY||Difference in least square mean change|-0.46||||0.002|TWO_SIDED|95.0|-0.75|-0.17|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo CIII/nonB||-0.17|-0.75|0.002
71014227|NCT01694849|141534886|SUPERIORITY||Difference in least square mean change|-0.39||||0.008|TWO_SIDED|95.0|-0.68|-0.1|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo CIII/nonB||-0.1|-0.68|0.008
70929623|NCT00303459|141356399|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.01||||0.9566|TWO_SIDED|95.0|-0.42|0.39|||Wilcoxon (Mann-Whitney)|||||0.39|-0.42|0.9566
70929624|NCT00303459|141356400|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.02||||0.5571|TWO_SIDED|95.0|-0.036|0.076|||Wilcoxon (Mann-Whitney)|||||0.076|-0.036|0.5571
70929625|NCT00303459|141356401|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.2||||0.4086|TWO_SIDED|95.0|-3.7|4.0|||Wilcoxon (Mann-Whitney)|||||4.0|-3.7|0.4086
70929626|NCT01570361|141356403|SUPERIORITY|||||||0.0009||||||Prior to the final analysis, study had two interim analyses. Hence alpha level is 0.0231 for primary analysis adjusted for the two interim analyses.|Log Rank|One-sided test||||||0.0009
70929627|NCT01570361|141356404|SUPERIORITY|||||||0.0118||||||The alpha level is 0.025 for this secondary endpoint.|Log Rank|One-sided test||||||0.0118
70929628|NCT01570361|141356405|SUPERIORITY|||||||0.0041||||||The alpha level is 0.025 for this secondary endpoint.|Log Rank|One-sided test||||||0.0041
70929629|NCT01116895|141356470|OTHER||Least square mean difference|-2.2||||0.89|TWO_SIDED|95.0|-32.6|28.2|||ANOVA|||||28.2|-32.6|0.89
70929630|NCT01116895|141356470|OTHER||Least square mean difference|4.5||||0.77|TWO_SIDED|95.0|-26.2|35.3|||ANOVA|||||35.3|-26.2|0.77
70929631|NCT01116895|141356470|OTHER||Least square mean difference|-6.7||||0.65|TWO_SIDED|95.0|-36.2|22.8|||ANOVA|||||22.8|-36.2|0.65
70929632|NCT04615273|141356504|SUPERIORITY||Estimate of Difference|-2.04|STANDARD_ERROR_OF_MEAN|0.46|<|0.0001|TWO_SIDED|95.0|-2.94|-1.14|||ANCOVA|||Analysis included treatment arm, region, baseline age group, gender, concomitant oral estrogen, Adult Growth Hormone Deficiency (AGHD) onset as factors \& baseline trunk percent fat as the covariates. Multiple imputation method was used to impute missing data.||-1.14|-2.94|<.0001
70929633|NCT05465239|141356508|EQUIVALENCE|Equivalence analysis of metabolic energy consumption using the unpowered vs powered walker for control subjects.|||||<|0.001|||||||t-test, 1 sided|||||||< 0.001
70929634|NCT05465239|141356508|EQUIVALENCE|Equivalence analysis of metabolic energy consumption using the unpowered vs powered walker for subjects with walking disabilities.|||||<|0.001|||||||t-test, 1 sided|||||||<0.001
70929635|NCT03673501|141356509|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.3598|TWO_SIDED|95.0|0.66|1.16|||Log Rank|Strata: by intolerance to imatinib treatment||||1.16|0.66|0.3598
70929636|NCT03673501|141356510|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7153|TWO_SIDED|95.0|0.82|1.33||Two-sided P-value|Log Rank|Strata: mutation status (KIT exon 9 vs. 11 vs. KIT/PDGFRA WT vs. other KIT {absence of exon 9 or 11}/PDGFRA) and intolerance to imatinib treatment||||1.33|0.82|0.7153
70929637|NCT03673501|141356511|SUPERIORITY|||||||0.0333|||||||Cochran-Mantel-Haenszel|Strata: intolerance to imatinib treatment||||||0.0333
70929638|NCT03673501|141356512|SUPERIORITY|||||||0.2681|||||||Cochran-Mantel-Haenszel|Strata: mutation status (KIT exon 9 vs. 11 vs. KIT/PDGFRA WT vs. other KIT {absence of exon 9 or 11}/PDGFRA) and intolerance to imatinib treatment||||||0.2681
71014228|NCT01694849|141534886|SUPERIORITY||Difference in least square mean change|-2.35||||0.069|TWO_SIDED|95.0|-4.89|0.19|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Small dense Low Density Lipoproteins||0.19|-4.89|0.069
71014229|NCT01694849|141534886|SUPERIORITY||Difference in least square mean change|-3.39||||0.01|TWO_SIDED|95.0|-5.95|-0.84|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Small dense Low Density Lipoproteins||-0.84|-5.95|0.01
70929639|NCT03673501|141356513|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7733|TWO_SIDED|95.0|0.75|1.48|||Log Rank|Strata: intolerance to imatinib treatment||||1.48|0.75|0.7733
70929640|NCT03673501|141356514|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.3928|TWO_SIDED|95.0|0.66|1.18|||Log Rank|Strata: mutation status (KIT exon 9 vs. 11 vs. KIT/PDGFRA WT vs. other KIT {absence of exon 9 or 11}/PDGFRA) and intolerance to imatinib||||1.18|0.66|0.3928
70929641|NCT02056834|141356617|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0166|||||||t-test, 2 sided|||Paired T-Test p-value tests the significance of the percent change from baseline within each treatment group.||||0.0166
71014230|NCT01694849|141534886|SUPERIORITY||Difference in least square mean change|0.84||||0.549|TWO_SIDED|95.0|-1.93|3.61|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Lp(a)||3.61|-1.93|0.549
71014231|NCT01694849|141534886|SUPERIORITY||Difference in least square mean change|0.49||||0.728|TWO_SIDED|95.0|-2.28|3.26|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Lp(a)||3.26|-2.28|0.728
71014232|NCT01694849|141534886|SUPERIORITY||Difference in least square mean change|-1.38|||<|0.001|TWO_SIDED|95.0|-2.14|-0.61|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo E||-0.61|-2.14|<0.001
71048924|NCT02944383|141606112|SUPERIORITY|||||||0.8982||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.8982
71048925|NCT02944383|141606112|SUPERIORITY|||||||0.6228||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.6228
71048926|NCT02944383|141606112|SUPERIORITY|||||||0.9622||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.9622
71048927|NCT02944383|141606112|SUPERIORITY|||||||0.6643||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.6643
71048928|NCT02944383|141606112|SUPERIORITY|||||||0.9071||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.9071
71048929|NCT02944383|141606113|SUPERIORITY|||||||0.5647||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.5647
71048930|NCT02944383|141606113|SUPERIORITY|||||||0.1073||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1073
70929642|NCT02056834|141356618|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3785|||||||t-test, 2 sided|||Paired T-Test p-value tests the significance of the percent change from baseline within each treatment group.||||0.3785
70850559|NCT02712047|141189436|OTHER||Ratio|0.58|||||TWO_SIDED|95.0|0.49|0.69|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 4, PM|||0.69|0.49|
70929643|NCT02056834|141356619|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||t-test, 2 sided|||Paired T-Test p-value tests the significance of the change from baseline within treatment group.||||<0.0001
70929644|NCT02056834|141356620|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||t-test, 2 sided|||Paired T-Test p-value tests the significance of the change from baseline within treatment group.||||<0.0001
70941535|NCT03722485|141383818|SUPERIORITY|||||||0.0213||||||Confounding variables of image capture techniques, image quality and image analysis noted throughout study conduct prohibits any definitive conclusions to be drawn from this analysis.|Wilcoxon (Mann-Whitney)|||||||0.0213
71014233|NCT01694849|141534886|SUPERIORITY||Difference in least square mean change|-1.12||||0.004|TWO_SIDED|95.0|-1.89|-0.36|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo E||-0.36|-1.89|0.004
71014234|NCT01694849|141534886|SUPERIORITY||Difference in least square mean change|-1.18|||<|0.001|TWO_SIDED|95.0|-1.82|-0.53|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo E/B||-0.53|-1.82|<0.001
71014235|NCT01694849|141534886|SUPERIORITY||Difference in least square mean change|-1.08||||0.001|TWO_SIDED|95.0|-1.72|-0.43|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo E/B||-0.43|-1.72|0.001
71014236|NCT01694849|141534887|SUPERIORITY||Difference in least square mean change|-2.8||||0.066|TWO_SIDED|95.0|-5.79|0.18|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Least square mean changes from baseline|||0.18|-5.79|0.066
71014237|NCT01694849|141534887|SUPERIORITY||Difference in least square mean change|0.77||||0.615|TWO_SIDED|95.0|-2.24|3.77|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||3.77|-2.24|0.615
71014238|NCT01694849|141534888|SUPERIORITY||Difference in least square mean change|-17.4||||0.307|TWO_SIDED|95.0|-50.88|16.08|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||16.08|-50.88|0.307
71014239|NCT01694849|141534888|SUPERIORITY||Difference in least square mean change|-21.41||||0.213|TWO_SIDED|95.0|-55.17|12.34|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||12.34|-55.17|0.213
71014240|NCT01694849|141534889|SUPERIORITY||Difference in least square mean change|-0.23||||0.003|TWO_SIDED|95.0|-0.37|-0.08|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.08|-0.37|0.003
71014241|NCT01694849|141534889|SUPERIORITY||Difference in least square mean change|-0.14||||0.068|TWO_SIDED|95.0|-0.29|0.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.01|-0.29|0.068
71014242|NCT01694849|141534890|SUPERIORITY||Difference in least square mean change|-0.8||||0.448|TWO_SIDED|95.0|-2.86|1.27|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||1.27|-2.86|0.448
71014243|NCT01694849|141534890|SUPERIORITY||Difference in least square mean change|-1.17||||0.267|TWO_SIDED|95.0|-3.25|0.9|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.9|-3.25|0.267
71014244|NCT01694849|141534891|SUPERIORITY||Difference in least square mean change|-0.05||||0.095|TWO_SIDED|95.0|-0.11|0.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.01|-0.11|0.095
71014245|NCT01694849|141534891|SUPERIORITY||Difference in least square mean change|-0.07||||0.022|TWO_SIDED|95.0|-0.13|-0.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.01|-0.13|0.022
71014246|NCT01694849|141534892|SUPERIORITY||Difference in least square mean change|-0.46||||0.077|TWO_SIDED|95.0|-0.96|0.05|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.05|-0.96|0.077
71014247|NCT01694849|141534892|SUPERIORITY||Difference in least square mean change|-0.36||||0.172|TWO_SIDED|95.0|-0.87|0.16|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.16|-0.87|0.172
71014248|NCT01694849|141534893|SUPERIORITY||Difference in least square mean change|-0.04||||0.732|TWO_SIDED|95.0|-0.24|0.17|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.17|-0.24|0.732
70850560|NCT02712047|141189436|OTHER||Ratio|0.63|||||TWO_SIDED|95.0|0.53|0.75|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 5, AM|||0.75|0.53|
71014249|NCT01694849|141534893|SUPERIORITY||Difference in least square mean change|-0.2||||0.062|TWO_SIDED|95.0|-0.4|0.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.01|-0.4|0.062
71014250|NCT01694849|141534894|SUPERIORITY||Difference in least square mean change|3.66||||0.4|TWO_SIDED|95.0|-4.89|12.2|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||12.2|-4.89|0.4
71014251|NCT01694849|141534894|SUPERIORITY||Difference in least square mean change|-16.22|||<|0.001|TWO_SIDED|95.0|-24.99|-7.44|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-7.44|-24.99|<0.001
71014252|NCT01694849|141534895|SUPERIORITY||Difference in least square mean change|-0.36|||<|0.001|TWO_SIDED|95.0|-0.54|-0.17|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Fibrinogen||-0.17|-0.54|<0.001
71014253|NCT01694849|141534895|SUPERIORITY||Difference in least square mean change|-0.27||||0.005|TWO_SIDED|95.0|-0.46|-0.08|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors||Fibrinogen|Standard error of the least square mean|-0.08|-0.46|0.005
71014254|NCT01694849|141534895|SUPERIORITY||Difference in least square mean change|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.15|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Haptoglobin||-0.15|-0.35|<0.001
71029277|NCT01226797|141566052|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|25.45||||0.1259|TWO_SIDED|95.0|-7.79|58.69||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 1||58.69|-7.79|0.1259
71029278|NCT01226797|141566052|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.49||||0.3297|TWO_SIDED|95.0|-14.67|41.66||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 2||41.66|-14.67|0.3297
71029279|NCT01226797|141566052|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.17||||0.3925|TWO_SIDED|95.0|-21.04|51.39||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 3||51.39|-21.04|0.3925
71029280|NCT01226797|141566052|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|24.62||||0.208|TWO_SIDED|95.0|-14.85|64.09||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 4||64.09|-14.85|0.2080
71029281|NCT01226797|141566054|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.87||||0.0577|TWO_SIDED|95.0|-0.78|44.53||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 1||44.53|-0.78|0.0577
71029282|NCT01226797|141566054|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.3||||0.3669|TWO_SIDED|95.0|-11.71|30.3||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 2||30.30|-11.71|0.3669
71048931|NCT02944383|141606113|SUPERIORITY|||||||0.3858||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3858
71048932|NCT02944383|141606113|SUPERIORITY|||||||0.0916||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0916
71048933|NCT02944383|141606113|SUPERIORITY||Median Difference (Net)|0.0||||0.9473|TWO_SIDED|95.0|-5.56|5.26||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||5.26|-5.56|0.9473
71048934|NCT02944383|141606113|SUPERIORITY||Median Difference (Net)|4.54||||0.0911|TWO_SIDED|95.0|-1.83|9.95||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||9.95|-1.83|0.0911
71048935|NCT02944383|141606114|SUPERIORITY|||||||0.4623||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.4623
71048936|NCT02944383|141606114|SUPERIORITY|||||||0.1678||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1678
71048937|NCT02944383|141606114|SUPERIORITY|||||||0.439||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4390
70850561|NCT02712047|141189436|OTHER||Ratio|0.67|||||TWO_SIDED|95.0|0.57|0.8|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 5, PM|||0.80|0.57|
71014255|NCT01694849|141534895|SUPERIORITY||Difference in least square mean change|-0.27|||<|0.001|TWO_SIDED|95.0|-0.37|-0.17|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Haptoglobin||-0.17|-0.37|<0.001
71014256|NCT01694849|141534896|SUPERIORITY||Difference in least square mean change|0.57||||0.742|TWO_SIDED|95.0|-2.9|4.06|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Tumour Necrosis Factor alpha||4.06|-2.9|0.742
71014257|NCT01694849|141534896|SUPERIORITY||Difference in least square mean change|2.9||||0.107|TWO_SIDED|95.0|-0.63|6.43|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Tumour Necrosis Factor alpha||6.43|-0.63|0.107
71014258|NCT01694849|141534896|SUPERIORITY||Difference in least square mean change|0.5||||0.362|TWO_SIDED|95.0|-0.58|1.59|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Interleukine 6||1.59|-0.58|0.362
71014259|NCT01694849|141534896|SUPERIORITY||Difference in least square mean change|0.07||||0.894|TWO_SIDED|95.0|-1.03|1.18|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Interleukine 6||1.18|-1.03|0.894
71014260|NCT01694849|141534897|SUPERIORITY||Difference in least square mean change|-0.76||||0.229|TWO_SIDED|95.0|-2.0|0.48|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.48|-2|0.229
71014261|NCT01694849|141534897|SUPERIORITY||Difference in least square mean change|-0.45||||0.463|TWO_SIDED|95.0|-1.67|0.76|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.76|-1.67|0.463
71014262|NCT01694849|141534898|SUPERIORITY||Difference in least square mean change|-0.21||||0.065|TWO_SIDED|95.0|-0.42|0.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.01|-0.42|0.065
71014263|NCT01694849|141534898|SUPERIORITY||Difference in least square mean change|-0.19||||0.098|TWO_SIDED|95.0|-0.41|0.03|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.03|-0.41|0.098
71014264|NCT01694849|141534899|SUPERIORITY||Difference in least square mean change|0.7||||0.553|TWO_SIDED|95.0|-1.61|3.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||3.01|-1.61|0.553
71014265|NCT01694849|141534899|SUPERIORITY||Difference in least square mean change|4.31|||<|0.001|TWO_SIDED|95.0|1.97|6.64|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||6.64|1.97|<0.001
71014266|NCT01694849|141534900|SUPERIORITY||Difference in least square mean change|0.04||||0.861|TWO_SIDED|95.0|-0.37|0.44|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.44|-0.37|0.861
71014267|NCT01694849|141534900|SUPERIORITY||Difference in least square mean change|-0.4||||0.052|TWO_SIDED|95.0|-0.81|0.0|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0|-0.81|0.052
71014268|NCT01694849|141534901|SUPERIORITY||Difference in least square mean change|0.01||||0.473|TWO_SIDED|95.0|-0.01|0.02|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.02|-0.01|0.473
71014269|NCT01694849|141534901|SUPERIORITY||Difference in least square mean change|0.01||||0.124|TWO_SIDED|95.0|0.0|0.03|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.03|0|0.124
71014270|NCT01694849|141534902|SUPERIORITY||Difference in least square mean change|0.81|||<|0.001|TWO_SIDED|95.0|0.47|1.15|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||1.15|0.47|<0.001
70929645|NCT06193070|141356634|OTHER|A one-tailed paired t-test was run to examine within subject mean difference on the cancer nutrition information beliefs scale pre- and post-game.|||||<|0.001||||||The threshold was set at alpha \< 0.05.|t-test, 1 sided|A paired samples t-test was run on pre- and post-game mean scores within subjects.||All participants were exposed to the intervention, and pre- and post-game scores within subject were examined.||||<.001
70850562|NCT02712047|141189436|OTHER||Ratio|0.67|||||TWO_SIDED|95.0|0.56|0.8|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 6, AM|||0.80|0.56|
71014271|NCT01694849|141534902|SUPERIORITY||Difference in least square mean change|0.85|||<|0.001|TWO_SIDED|95.0|0.5|1.19|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||1.19|0.5|<0.001
71014272|NCT01694849|141534903|SUPERIORITY||Difference in least square mean change|0.0||||0.842|TWO_SIDED|95.0|-0.04|0.04|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.04|-0.04|0.842
71014273|NCT01694849|141534903|SUPERIORITY||Difference in least square mean change|0.01||||0.589|TWO_SIDED|95.0|-0.03|0.05|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.05|-0.03|0.589
71014274|NCT01694849|141534904|SUPERIORITY||Difference in least square mean change|48.93||||0.325|TWO_SIDED|95.0|-8.73|146.6|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||146.6|-8.73|0.325
71014275|NCT01694849|141534904|SUPERIORITY||Difference in least square mean change|93.21||||0.066|TWO_SIDED|95.0|-6.06|192.49|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||192.49|-6.06|0.066
71014276|NCT01694849|141534905|SUPERIORITY||Difference in least square mean change|2.41|||<|0.001|TWO_SIDED|95.0|1.1|3.72|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||3.72|1.1|<0.001
71014277|NCT01694849|141534905|SUPERIORITY||Difference in least square mean change|1.59||||0.019|TWO_SIDED|95.0|0.26|2.91|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||2.91|0.26|0.019
71014278|NCT01694849|141534906|SUPERIORITY||Difference in least square mean change|0.0||||0.447|TWO_SIDED|95.0|0.0|0.0|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0|0|0.447
71014279|NCT01694849|141534906|SUPERIORITY||Difference in least square mean change|0.0||||0.758|TWO_SIDED|95.0|0.0|0.0|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0|0|0.758
71014280|NCT01694849|141534907|SUPERIORITY||Difference in least square mean change|-0.04||||0.942|TWO_SIDED|95.0|-1.12|1.04|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||1.04|-1.12|0.942
71014281|NCT01694849|141534907|SUPERIORITY||Difference in least square mean change|0.57||||0.304|TWO_SIDED|95.0|-0.52|1.66|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||1.66|-0.52|0.304
71014282|NCT00908375|141534912|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was determined based on the primary outcome variable, the VAS pain score at three weeks. Based on the results of the study of Siddall et al., group sample sizes of 19 and 19 achieve 82% power to detect a difference of 2.00 between the null hypothesis that both group means are 6.50 and the alternative hypothesis that the mean of pregabalin group is 4.50 with estimated group standard deviations of 2.10 and 2.10 and with a significance level of 0.05 using a two-sided two-sample t-test.|Median Difference (Final Values)|-2.0||||0.279|TWO_SIDED|99.0|-6.0|3.0||The criterion for rejection of the null hypothesis (P \< 0.05) was adjusted for multiple application of the test to the same data set using the Bonferroni correction.|Wilcoxon (Mann-Whitney)|||||3|-6|0.279
71014283|NCT00908375|141534913|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0||||0.282|TWO_SIDED|99.0|-2.0|1.0||The criterion for rejection of the null hypothesis (P \< 0.05) was adjusted for multiple applications of the test to the same data using the Bonferroni correction.|Wilcoxon (Mann-Whitney)|||||1.0|-2.0|0.282
71014284|NCT00908375|141534914|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-16.0||||0.139|TWO_SIDED|99.0|-42.0|16.0||The criterion for rejection of the null hypothesis (P \< 0.05) was adjusted for multiple applications of the test to the same data using the Bonferroni correction.|Wilcoxon (Mann-Whitney)|||||16|-42|0.139
71014285|NCT05770401|141534935|SUPERIORITY||Mean Difference (Final Values)|3.24|STANDARD_ERROR_OF_MEAN|1.227||0.014|TWO_SIDED|95.0|0.72|5.76|||ANCOVA|||The null hypothesis was there would be no significant difference in LCQ total score change from baseline to one-week post-treatment between groups.||5.76|.72|.014
70850563|NCT02712047|141189436|OTHER||Ratio|0.62|||||TWO_SIDED|95.0|0.52|0.74|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 6, PM|||0.74|0.52|
71014286|NCT05770401|141534936|SUPERIORITY||Mean Difference (Final Values)|-16.1|STANDARD_ERROR_OF_MEAN|8.804||0.056|TWO_SIDED|95.0|-32.7|0.46|||ANCOVA|||The null hypothesis was there would be no significant difference in Cough Severity VAS Scores from baseline to one-week post-treatment between groups.||0.46|-32.7|.056
71014287|NCT00480077|141534940|SUPERIORITY|The primary end point of the study, all-cause death or hospitalization for heart failure, was analyzed on a time-to-first-event basis with the log-rank test. The hazard ratio (HR) associated with allocation to the access arm relative to control was estimated with corresponding 95% confidence interval (CI) by fitting a Cox proportional hazards model containing the treatment group as a categorical factor.||||||0.063|||||||Log Rank|||||||0.063
71029283|NCT01226797|141566054|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.09||||0.2482|TWO_SIDED|95.0|-10.62|38.8||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 3||38.80|-10.62|0.2482
71029284|NCT01226797|141566054|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29.19||||0.0801|TWO_SIDED|95.0|-3.84|62.22||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 4||62.22|-3.84|0.0801
71029285|NCT01226797|141566062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.06||||0.0031|TWO_SIDED|95.0|-35.67|-8.44||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 2||-8.44|-35.67|0.0031
71029286|NCT01226797|141566062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.34||||0.0015|TWO_SIDED|95.0|-25.64|-7.04||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 4||-7.04|-25.64|0.0015
71014288|NCT01683565|141534994|OTHER|Analyses compared the change in Pervasive Developmental Disorders Screening Test-II scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.67||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The sample size was determined based on the goal of confirming trial feasibility and estimating effect sizes for a full-scale trial, not for a definitive test of efficacy. The enrollment goal was 40, which would have provided an indication of an expected effect size for a larger full-scale trial (e.g., 53% power to detect a 2-point decrease (approximately 0.7-SD based on a prior study) in Pervasive Developmental Disorders Screening Test-II score). Funding limitations capped enrollment at 31.||||0.67
71014289|NCT01683565|141534995|OTHER|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.22||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|||The reported p-value is for the comparison of the change in Competence scores between groups (LCPUFA vs. Placebo).||||0.22
71014290|NCT01683565|141534995|OTHER|Analyses compared the change in the BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes||||||0.92||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|||The reported p-value is for the comparison of the change in Problem scores between groups (LCPUFA vs. Placebo).||||0.92
71014291|NCT01683565|141534995|OTHER|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.88|||||||Mixed Models Analysis|||The reported p-value is for the comparison of the change in Dysregulation scores between groups (LCPUFA vs. Placebo).||||0.88
71014292|NCT01683565|141534995|OTHER|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.23|||||||Mixed Models Analysis|||The reported p-value is for the comparison of the change in Externalizing scores between groups (LCPUFA vs. Placebo).||||0.23
71014293|NCT01683565|141534995|OTHER|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.91|||||||Mixed Models Analysis|||The reported p-value is for the comparison of the change in Internalizing scores between groups (LCPUFA vs. Placebo).||||0.91
70850564|NCT02712047|141189436|OTHER||Ratio|0.6|||||TWO_SIDED|95.0|0.51|0.71|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 7, AM|||0.71|0.51|
71014294|NCT01683565|141534995|OTHER|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.03|||||||Mixed Models Analysis|||The reported p-value is for the comparison of the change in Austism Spectrum Disorder scores between groups (LCPUFA vs. Placebo).||||0.03
71014295|NCT01683565|141534995|OTHER|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.07|||||||Mixed Models Analysis|||The reported p-value is for the comparison of the change in Red Flag scores between groups (LCPUFA vs. Placebo).||||0.07
70850565|NCT02712047|141189436|OTHER||Ratio|0.62|||||TWO_SIDED|95.0|0.52|0.74|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 7, PM|Ratio of FF/VI 100/25mcg Vs Placebo for Day 8, AM||0.74|0.52|
70850566|NCT02712047|141189436|OTHER||Ratio|0.69|||||TWO_SIDED|95.0|0.58|0.81|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 8, AM|||0.81|0.58|
71014296|NCT01683565|141534996|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.31||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (10:0 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.31
71014297|NCT01683565|141534996|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.47||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (12:0 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.47
71014298|NCT01683565|141534996|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.38||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (14:0 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.38
71014299|NCT01683565|141534996|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.02||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (16:0 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.02
71014300|NCT01683565|141534996|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.16||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (16:1n-7 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.16
71014301|NCT01683565|141534996|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.02||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:0 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.02
71014302|NCT01683565|141534996|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.02||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:1n-9 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.02
71014303|NCT01683565|141534996|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.21||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:2n-6 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.21
71014304|NCT01683565|141534996|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.34||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:3n-6 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.34
71014305|NCT01683565|141534996|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.24||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:3n-3 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.24
71014306|NCT01683565|141534996|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.5||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:4n-3 nmol/mL ) between groups (LCPUFA vs. Placebo).||||0.50
71014307|NCT01683565|141534996|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.07||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (20:3n-6 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.07
71014308|NCT01683565|141534996|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.1||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (20:4n-6 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.10
71014309|NCT01683565|141534996|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.001||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (20:5n-3 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.001
71014310|NCT01683565|141534996|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.71||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (22:5n-3 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.71
71014311|NCT01683565|141534996|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.001||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (22:6n-3 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.001
71014312|NCT01683565|141534996|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.1||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (Total Omega-6) between groups (LCPUFA vs. Placebo).||||0.10
71014313|NCT01683565|141534996|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.1||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (total omega-3) between groups (LCPUFA vs. Placebo).||||0.10
71014314|NCT05261126|141535007|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-41.2|||<|0.001|TWO_SIDED|95.0|-47.8|-34.7|||cLDA||MK-0616 6 mg minus Placebo|||-34.7|-47.8|<0.001
71014315|NCT05261126|141535007|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-55.7|||<|0.001|TWO_SIDED|95.0|-62.3|-49.1|||cLDA||MK-0616 12 mg minus Placebo|||-49.1|-62.3|<0.001
71048938|NCT02944383|141606114|SUPERIORITY|||||||0.129||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1290
71048939|NCT02944383|141606114|SUPERIORITY|||||||0.9627||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.9627
70850567|NCT02712047|141189436|OTHER||Ratio|0.68|||||TWO_SIDED|95.0|0.57|0.8|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 8, PM|||0.80|0.57|
70929646|NCT03926130|141356640|SUPERIORITY||Risk Difference (RD)|28.7|||<|1e-06|TWO_SIDED|95.0|23.0|34.4|||Cochran-Mantel-Haenszel|||||34.4|23.0|<0.000001
70929647|NCT03926130|141356641|SUPERIORITY||Risk Difference (RD)|25.8|||<|1e-06|TWO_SIDED|95.0|18.8|32.7|||Cochran-Mantel-Haenszel|||||32.7|18.8|<0.000001
70929648|NCT03926130|141356642|SUPERIORITY||Risk Difference (RD)|19.7|||<|1e-06|TWO_SIDED|95.0|13.7|25.6|||Cochran-Mantel-Haenszel|||||25.6|13.7|<0.000001
70929649|NCT03926130|141356643|SUPERIORITY||Risk Difference (RD)|39.1|||<|1e-06|TWO_SIDED|95.0|33.4|44.8|||Cochran-Mantel-Haenszel|||||44.8|33.4|<0.000001
71014316|NCT05261126|141535007|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-59.1|||<|0.001|TWO_SIDED|95.0|-65.7|-52.5|||cLDA||MK-0616 18 mg minus Placebo|||-52.5|-65.7|<0.001
71014317|NCT05261126|141535007|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-60.9|||<|0.001|TWO_SIDED|95.0|-67.6|-54.3|||cLDA||MK-0616 30 mg minus Placebo|||-54.3|-67.6|<0.001
71014318|NCT05261126|141535008|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in Percentage|0.2|||||TWO_SIDED|95.0|-15.5|15.8|||||MK-0616 6 mg minus Placebo|||15.8|-15.5|
71048940|NCT02944383|141606114|SUPERIORITY|||||||0.0911||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0911
70929650|NCT03926130|141356643|SUPERIORITY||Risk Difference (RD)|2.3||||0.513623|TWO_SIDED|95.0|-4.7|9.3|||Cochran-Mantel-Haenszel|||||9.3|-4.7|0.513623
70929651|NCT03926130|141356644|SUPERIORITY||Risk Difference (RD)|12.4||||0.001431|TWO_SIDED|95.0|5.3|19.6|||Cochran-Mantel-Haenszel|||||19.6|5.3|0.001431
70929652|NCT03926130|141356645|SUPERIORITY||Risk Difference (RD)|34.6|||<|1e-06|TWO_SIDED|95.0|27.7|41.4|||Cochran-Mantel-Haenszel|||||41.4|27.7|<0.000001
70929653|NCT03926130|141356645|NON_INFERIORITY|The non-inferiority margin is 10%. We do not have power calculation in the SAP for this endpoint.|Risk Difference (RD)|5.7|||<|0.0001|TWO_SIDED|95.0|-1.4|12.8|||Z test|||||12.8|-1.4|<0.0001
70929654|NCT03926130|141356646|SUPERIORITY||Risk Difference (RD)|6.8||||0.003414|TWO_SIDED|95.0|3.2|10.5|||Cochran-Mantel-Haenszel|||||10.5|3.2|0.003414
70929655|NCT03926130|141356647|SUPERIORITY||LSMean Difference (Net)|-0.86||||1.1e-05|TWO_SIDED|95.0|-1.24|-0.48|||ANCOVA|||||-0.48|-1.24|0.000011
70929656|NCT03926130|141356648|SUPERIORITY||LSMean Difference (Net)|-2.01|||<|1e-06|TWO_SIDED|95.0|-2.42|-1.6|||ANCOVA|||||-1.60|-2.42|<0.000001
70929657|NCT03926130|141356649|SUPERIORITY||Risk Difference (RD)|25.7|||<|1e-06|TWO_SIDED|95.0|18.9|32.6|||Cochran-Mantel-Haenszel|||||32.6|18.9|<0.000001
70929658|NCT03926130|141356650|SUPERIORITY||Risk Difference (RD)|13.8|||<|1e-06|TWO_SIDED|95.0|10.2|17.4|||Cochran-Mantel-Haenszel|||||17.4|10.2|<0.000001
71014319|NCT05261126|141535008|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in Percentage|-4.5|||||TWO_SIDED|95.0|-20.0|11.2|||||MK-0616 12 mg vs Placebo|||11.2|-20.0|
70929659|NCT03926130|141356651|SUPERIORITY||Risk Difference (RD)|25.0|||<|1e-06|TWO_SIDED|95.0|18.2|31.8|||Cochran-Mantel-Haenszel|||||31.8|18.2|<0.000001
70929660|NCT03926130|141356652|SUPERIORITY||LSMean Difference (Net)|-0.85|||<|1e-06|TWO_SIDED|95.0|-1.05|-0.65|||ANCOVA|||||-0.65|-1.05|<0.000001
70929661|NCT03926130|141356653|SUPERIORITY||LSMean Difference (Net)|-1.22|||<|1e-06|TWO_SIDED|95.0|-1.48|-0.95|||ANCOVA|||||-0.95|-1.48|<0.000001
70929662|NCT03926130|141356654|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70929663|NCT03926130|141356655|SUPERIORITY||Risk Difference (RD)|4.1||||0.732715|TWO_SIDED|95.0|-18.0|26.1|||Cochran-Mantel-Haenszel|||||26.1|-18.0|0.732715
70929664|NCT03926130|141356656|SUPERIORITY||LSMean Difference (Net)|27.92|||<|1e-06|TWO_SIDED|95.0|22.67|33.18|||ANCOVA|||||33.18|22.67|<0.000001
70929665|NCT03926130|141356658|SUPERIORITY||Risk Difference (RD)|10.6||||0.000213|TWO_SIDED|99.5|4.1|17.2|||Cochran-Mantel-Haenszel|||||17.2|4.1|0.000213
70929666|NCT03926130|141356659|SUPERIORITY||Risk Difference (RD)|19.4|||<|1e-06|TWO_SIDED|99.5|13.1|25.7|||Cochran-Mantel-Haenszel|||||25.7|13.1|<0.000001
70929667|NCT03583333|141356660|NON_INFERIORITY|Non-inferiority margin for the difference in mortality (IMI/REL minus PIP/TAZ) was 12.5%.|Adjusted difference in percentage|5.2||||0.024|TWO_SIDED|95.0|-1.5|12.4|||Miettinen & Nurminen method||Adjusted differences and the 95% confidence intervals (CIs) are based on Miettinen \& Nurminen method stratified by randomization stratum.|||12.4|-1.5|0.024
70929668|NCT03583333|141356660|SUPERIORITY||Adjusted difference in percentage|5.2||||0.938|TWO_SIDED|95.0|-1.5|12.4|||Miettinen & Nurminen|Adjusted differences and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.||||12.4|-1.5|0.938
70929669|NCT03583333|141356661|OTHER||Adjusted difference in percentage|3.1|||||TWO_SIDED|95.0|-8.7|14.9|||||Adjusted differences and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||14.9|-8.7|
70929670|NCT03583333|141356662|OTHER||Adjusted difference in percentage|2.2|||||TWO_SIDED|95.0|-12.4|16.8|||||Adjusted difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||16.8|-12.4|
70929671|NCT03583333|141356663|OTHER||Adjusted difference in percentage|3.4|||||TWO_SIDED|95.0|-7.6|14.3|||||Adjusted difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||14.3|-7.6|
70929672|NCT03583333|141356664|OTHER||Adjusted difference in percentage|-4.7|||||TWO_SIDED|95.0|-15.8|6.6|||||Adjusted difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||6.6|-15.8|
70929673|NCT03583333|141356665|OTHER||Adjusted difference in percentage|-2.4|||||TWO_SIDED|95.0|-17.8|13.1|||||Adjusted differences and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||13.1|-17.8|
70929674|NCT03583333|141356666|OTHER||Adjusted difference in percentage|1.4|||||TWO_SIDED|95.0|-16.5|19.8|||||Adjusted difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||19.8|-16.5|
70929675|NCT03583333|141356667|OTHER||Adjusted difference in percentage|-3.1|||||TWO_SIDED|95.0|-19.8|14.4|||||Adjusted difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||14.4|-19.8|
70929676|NCT03583333|141356668|OTHER||Adjusted difference in percentage|2.0|||||TWO_SIDED|95.0|-6.5|10.6|||||Difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||10.6|-6.5|
70929677|NCT03583333|141356669|OTHER||Adjusted difference in percentage|-4.4|||||TWO_SIDED|95.0|-10.7|1.4|||||Difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||1.4|-10.7|
70929678|NCT03580356|141356702|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|9.029|||<|0.0001|TWO_SIDED|95.0|3.183|25.615|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||25.615|3.183|<.0001
70929679|NCT03580356|141356702|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|0.926||||0.6646|TWO_SIDED|95.0|0.65|1.319|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||1.319|0.650|0.6646
70929680|NCT03580356|141356702|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|11.508|||<|0.0001|TWO_SIDED|95.0|4.058|32.638|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||32.638|4.058|<.0001
70929681|NCT03580356|141356702|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio, log|1.181||||0.173|TWO_SIDED|95.0|0.836|1.667|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||1.667|0.836|0.1730
70929682|NCT03580356|141356703|SUPERIORITY||LS Mean|-9.997|STANDARD_ERROR_OF_MEAN|1.305|<|0.0001|TWO_SIDED|95.0|-12.554|-7.439|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults only||-7.439|-12.554|<.0001
70929683|NCT03580356|141356703|SUPERIORITY||LS mean|0.414|STANDARD_ERROR_OF_MEAN|0.922||0.6735|TWO_SIDED|95.0|-1.392|2.221|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults only||2.221|-1.392|0.6735
70929684|NCT03580356|141356703|SUPERIORITY||LS Mean|-11.091|STANDARD_ERROR_OF_MEAN|1.313|<|0.0001|TWO_SIDED|95.0|-13.664|-8.518|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults only||-8.518|-13.664|<.0001
70929685|NCT03580356|141356703|SUPERIORITY||LS mean|-0.68|STANDARD_ERROR_OF_MEAN|0.923||0.2305|TWO_SIDED|95.0|-2.489|1.128|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults only||1.128|-2.489|0.2305
70929686|NCT03580356|141356705|SUPERIORITY||LS Mean|-4.105|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|-5.281|-2.929|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Adults only||-2.929|-5.281|<.0001
70929687|NCT03580356|141356705|SUPERIORITY||LS Mean|0.101|STANDARD_ERROR_OF_MEAN|0.422||0.5943|TWO_SIDED|95.0|-0.727|0.928|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Adults only||0.928|-0.727|0.5943
70929688|NCT03580356|141356705|SUPERIORITY|Adults only|LS Mean|-4.496|STANDARD_ERROR_OF_MEAN|0.603|<|0.0001|TWO_SIDED|95.0|-5.678|-3.314|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||||-3.314|-5.678|<.0001
70929689|NCT03580356|141356705|SUPERIORITY||LS Mean|-0.29|STANDARD_ERROR_OF_MEAN|0.423||0.2467|TWO_SIDED|95.0|-1.12|0.54|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Adults only||0.540|-1.120|0.2467
70850568|NCT02712047|141189436|OTHER||Ratio|0.66|||||TWO_SIDED|95.0|0.56|0.78|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 9, AM|||0.78|0.56|
71104350|NCT02757768|141715914|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.128|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.0|-0.3|0.128
70929690|NCT03580356|141356707|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|3.443|||<|0.0001|TWO_SIDED|95.0|1.955|6.063|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||6.063|1.955|<.0001
70929691|NCT03580356|141356707|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|0.838||||0.8524|TWO_SIDED|95.0|0.602|1.167|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||1.167|0.602|0.8524
70929692|NCT03580356|141356707|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|4.542|||<|0.0001|TWO_SIDED|95.0|2.577|8.004|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||8.004|2.577|<.0001
70929693|NCT03580356|141356707|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|1.106||||0.2764|TWO_SIDED|95.0|0.794|1.54|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||1.540|0.794|0.2764
70929694|NCT03580356|141356708|SUPERIORITY||Risk Ratio (RR)|1.389|||<|0.0001|TWO_SIDED|95.0|1.235|1.561|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults only||1.561|1.235|<.0001
70929695|NCT03580356|141356708|SUPERIORITY||Risk Ratio (RR)|1.029||||0.2369|TWO_SIDED|95.0|0.952|1.111|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults only||1.111|0.952|0.2369
70929696|NCT03580356|141356708|SUPERIORITY||Risk Ratio (RR)|1.425|||<|0.0001|TWO_SIDED|95.0|1.268|1.603|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults only||1.603|1.268|<.0001
70929697|NCT03580356|141356708|SUPERIORITY||Risk Ratio (RR)|1.056||||0.083|TWO_SIDED|95.0|0.978|1.14|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults only||1.140|0.978|0.0830
70929698|NCT03536884|141356720|NON_INFERIORITY|The evaluation of noninferiority is tested at a 1-sided alpha level of 0.025 and based on a 1-sided 97.5% CI and a noninferiority margin of 10%.|Risk Difference (RD)|12.682|||||TWO_SIDED|95.0|5.771|19.592||||||Risk Difference: BKZ-Secukinumab calculated using stratified Cochran-Mantel-Haenszel (CMH).||19.592|5.771|
70929699|NCT03536884|141356720|SUPERIORITY||Odds Ratio (OR)|1.714|||<|0.001|TWO_SIDED|95.0|1.271|2.31||P-values for the comparison of treatment groups are based on the CMH test for the general association.|Cochran-Mantel-Haenszel|||Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||2.310|1.271|<0.001
70929700|NCT03536884|141356721|SUPERIORITY||Odds Ratio (OR)|2.817|||<|0.001|TWO_SIDED|95.0|2.068|3.836||P-values for the comparison of treatment groups are based on the CMH test from the general association. P-values are not controlled for multiplicity and should only be considered descriptively.|Cochran-Mantel-Haenszel|||Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||3.836|2.068|<0.001
70929701|NCT03536884|141356723|SUPERIORITY||Odds Ratio (OR)|2.49|||<|0.001|TWO_SIDED|95.0|1.835|3.377||P-values for the comparison of treatment groups are based on the CMH test from the general association. P-values are not controlled for multiplicity and should only be considered descriptively.|Cochran-Mantel-Haenszel|||Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||3.377|1.835|<0.001
70929702|NCT03536884|141356723|SUPERIORITY||Odds Ratio (OR)|2.168|||<|0.001|TWO_SIDED|95.0|1.511|3.11||P-values for the comparison of treatment groups are based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||3.110|1.511|<0.001
70929703|NCT03536884|141356723|SUPERIORITY||Odds Ratio (OR)|3.243|||<|0.001|TWO_SIDED|95.0|2.103|5.0||P-values for the comparison of treatment groups are based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||5.000|2.103|<0.001
70929704|NCT03331835|141356735|SUPERIORITY||Risk Difference (RD)|42.86|||<|0.001|TWO_SIDED|95.0|30.93|54.79|||Cochran-Mantel-Haenszel|95% CI and p-value are derived from CMH analysis stratified by weight group at baseline (≤100 kg, \> 100 kg).||Estimated risk difference, 95% CI and p-value are derived from Cochran-Mantel-Haenszel (CMH) analysis stratified by weight group at baseline (≤100 kg, \> 100 kg). Non-responder Imputation (NRI) was used to impute missing data. Treatment groups were defined as randomised treatment.||54.79|30.93|<0.001
70929705|NCT03331835|141356736|SUPERIORITY||Risk Difference (RD)|44.76|||<|0.001|TWO_SIDED|95.0|32.81|56.71|||Cochran-Mantel-Haenszel|95% CI and p-value are derived from CMH analysis stratified by weight group at baseline (≤100 kg, \> 100 kg)||Estimated risk difference, 95% CI and p-value are derived from Cochran-Mantel-Haenszel (CMH) analysis stratified by weight group at baseline (≤100 kg, \> 100 kg). Non-responder Imputation (NRI) was used to impute missing data. Treatment groups were defined as randomised treatment.||56.71|32.81|<0.001
70929706|NCT03331835|141356737|SUPERIORITY||Risk Difference (RD)|43.81|||<|0.001|TWO_SIDED|95.0|31.78|55.84|||Cochran-Mantel-Haenszel|||Estimated risk difference, 95% CI and p-value are derived from Cochran-Mantel-Haenszel (CMH) analysis stratified by weight group at baseline (≤100 kg, \> 100 kg). Non-responder Imputation (NRI) was used to impute missing data. Treatment groups were defined as randomised treatment.||55.84|31.78|<0.001
70941536|NCT03722485|141383819|SUPERIORITY|||||||0.7422||||||Confounding variables of image capture techniques, image quality and image analysis noted throughout study conduct prohibits any definitive conclusions to be drawn from this analysis.|Wilcoxon (Mann-Whitney)|||||||0.7422
71104351|NCT02757768|141715914|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.054|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.0|-0.4|0.054
71104352|NCT02757768|141715914|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.079|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.0|-0.4|0.079
71048941|NCT02944383|141606115|SUPERIORITY|||||||0.2882||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.2882
71048942|NCT02944383|141606115|SUPERIORITY|||||||0.4474||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.4474
71048943|NCT02944383|141606115|SUPERIORITY|||||||0.7875||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7875
71048944|NCT02944383|141606115|SUPERIORITY|||||||0.06||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0600
71048945|NCT02944383|141606115|SUPERIORITY||Median Difference (Net)|0.0||||0.9832|TWO_SIDED|95.0|0.0|0.0||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||0.00|0.00|0.9832
71048946|NCT02944383|141606115|SUPERIORITY||Median Difference (Net)|0.0||||0.1352|TWO_SIDED|95.0|0.0|0.0||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||0.00|0.00|0.1352
71048947|NCT02944383|141606116|SUPERIORITY|||||||0.2857||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|ranked ANCOVA|||Week 10||||0.2857
71048948|NCT02944383|141606116|SUPERIORITY|||||||0.4486||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.4486
71048949|NCT02944383|141606116|SUPERIORITY|||||||0.764||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7640
71048950|NCT02944383|141606116|SUPERIORITY|||||||0.056||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0560
71104353|NCT02757768|141715914|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.148|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.4|0.148
71104354|NCT02757768|141715915|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.25||0.66|TWO_SIDED|95.0|-0.61|0.39|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.39|-0.61|0.660
70850569|NCT02712047|141189436|OTHER||Ratio|0.68|||||TWO_SIDED|95.0|0.57|0.8|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 9, PM|||0.80|0.57|
71048951|NCT02944383|141606116|SUPERIORITY|||||||0.9954||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.9954
71048952|NCT02944383|141606116|SUPERIORITY|||||||0.1298||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.1298
71048953|NCT02944383|141606117|SUPERIORITY|||||||0.0161||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate|Ranked ANCOVA|||Week 10||||0.0161
71048954|NCT02944383|141606117|SUPERIORITY|||||||0.1806||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate|Ranked ANCOVA|||Week 10||||0.1806
71048955|NCT02944383|141606117|SUPERIORITY|||||||0.2657||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate|Ranked ANCOVA|||Week 12||||0.2657
71048956|NCT02944383|141606117|SUPERIORITY|||||||0.5996||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate|Ranked ANCOVA|||Week 12||||0.5996
71104355|NCT02757768|141715915|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.32||0.767|TWO_SIDED|95.0|-0.72|0.53|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.53|-0.72|0.767
70850570|NCT02712047|141189436|OTHER||Ratio|0.66|||||TWO_SIDED|95.0|0.55|0.78|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 10, AM|||0.78|0.55|
71014320|NCT05261126|141535008|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in Percentage|-0.6|||||TWO_SIDED|95.0|-16.3|15.1|||||MK-0616 18 mg vs Placebo|||15.1|-16.3|
71014321|NCT05261126|141535008|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in Percentage|-1.9|||||TWO_SIDED|95.0|-17.5|13.8|||||MK-0616 30 mg minus Placebo|||13.8|-17.5|
71014322|NCT05261126|141535010|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-32.8|||<|0.001|TWO_SIDED|95.0|-38.6|-26.9|||cLDA||MK-0616 6 mg minus Placebo|||-26.9|-38.6|<0.001
71014323|NCT05261126|141535010|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-45.8|||<|0.001|TWO_SIDED|95.0|-51.7|-39.9|||cLDA||MK-0616 12 mg minus Placebo|||-39.9|-51.7|<0.001
71014324|NCT05261126|141535010|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-48.7|||<|0.001|TWO_SIDED|95.0|-54.6|-42.8|||cLDA||MK-0616 18 mg minus Placebo|||-42.8|-54.6|<0.001
71014325|NCT05261126|141535010|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Square Means|-51.8|||<|0.001|TWO_SIDED|95.0|-57.7|-45.9|||cLDA||MK-0616 30 mg minus Placebo|||-45.9|-57.7|<0.001
71014326|NCT05261126|141535011|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-35.9|||<|0.001|TWO_SIDED|95.0|-42.4|-29.4|||cLDA||MK-0616 6 mg minus Placebo|||-29.4|-42.4|<0.001
71014327|NCT05261126|141535011|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-50.5|||<|0.001|TWO_SIDED|95.0|-57.0|-44.0|||cLDA||MK-0616 12 mg minus Placebo|||-44.0|-57.0|<0.001
71014328|NCT05261126|141535011|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-53.2|||<|0.001|TWO_SIDED|95.0|-59.7|-46.7|||cLDA||MK-0616 18 mg minus Placebo|||-46.7|-59.7|<0.001
71014329|NCT05261126|141535011|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-55.8|||<|0.001|TWO_SIDED|95.0|-62.3|-49.3|||cLDA||MK-0616 30 mg minus Placebo|||-49.3|-62.3|<0.001
71014330|NCT05261126|141535012|SUPERIORITY|One-sided p-value and difference in percentage based on Miettinen \& Nurminen method, with sample size weighting, stratified by background statin intensity.|Difference in Percentage|69.2|||<|0.001|TWO_SIDED|95.0|56.2|79.0|||Miettinen & Nurminen||MK-0616 6 mg minus Placebo|||79.0|56.2|<0.001
71014331|NCT05261126|141535012|SUPERIORITY|One-sided p-value and difference in percentage based on Miettinen \& Nurminen method, with sample size weighting, stratified by background statin intensity.|Difference in Percentage|75.2|||<|0.001|TWO_SIDED|95.0|62.9|84.0|||Miettinen & Nurminen method||MK-0616 12 mg minus Placebo|||84.0|62.9|<0.001
71014332|NCT05261126|141535012|SUPERIORITY|One-sided p-value and difference in percentage based on Miettinen \& Nurminen method, with sample size weighting, stratified by background statin intensity.|Difference in Percentage|79.2|||<|0.001|TWO_SIDED|95.0|67.1|87.1|||Miettinen & Nurminen method||MK-0616 18 mg minus Placebo|||87.1|67.1|<0.001
71014333|NCT05261126|141535012|SUPERIORITY|One-sided p-value and difference in percentage based on Miettinen \& Nurminen method, with sample size weighting, stratified by background statin intensity.|Difference in Percentage|79.5|||<|0.001|TWO_SIDED|95.0|67.9|87.4|||Miettinen & Nurminen method||MK-0616 30 mg minus Placebo|||87.4|67.9|<0.001
71014334|NCT03901274|141535013|SUPERIORITY||Slope|-0.16|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|95.0|-0.74|0.42|||||Parameter estimated with full information maximum likelihood|Intent-to-treat on three month outcomes with intake (i.e. Pretest covariate)||0.42|-0.74|
71014335|NCT03901274|141535013|SUPERIORITY||Slope|-0.65|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|95.0|-1.2|-0.09|||||Parameter estimated with full information maximum likelihood|Intent-to-treat on six month outcomes with intake (i.e. Pretest covariate)||-0.09|-1.20|
71014336|NCT00145119|141535049|SUPERIORITY_OR_OTHER_LEGACY||proportion (%)|8.0||||||||||||||||||
71014337|NCT03671746|141535066|SUPERIORITY||Median Difference (Final Values)|1.5|STANDARD_DEVIATION|1.5|=|0.275|TWO_SIDED||||||ANOVA|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed using Length of Stay (LOS) as this was the primary outcome. Using a significance level of 0.05 and assumed standard deviation of 1.5 days, a sample size of 42 patients/group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was planned for 56 patients/group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).||||=0.275
71014338|NCT03671746|141535067|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed using LOS as this was the primary outcome. Using a significance level of 0.05 and an assumed standard deviation of 1.5 days, a sample size of 42 patients/group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients/group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).||||<0.05
71014339|NCT03671746|141535068|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|The VAS model was adjusted for baseline levels as a covariate, which differed significantly between groups.||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).||||<0.05
70929707|NCT03331835|141356738|SUPERIORITY||Risk Difference (RD)|31.43|||<|0.001|TWO_SIDED|95.0|20.76|42.1|||Cochran-Mantel-Haenszel|||Estimated risk difference, 95% CI and p-value are derived from Cochran-Mantel-Haenszel (CMH) analysis stratified by weight group at baseline (≤100 kg, \> 100 kg). Non-responder Imputation (NRI) was used to impute missing data. Treatment groups were defined as randomised treatment.||42.10|20.76|<0.001
70929708|NCT03331835|141356739|SUPERIORITY||Mean Difference (Net)|-3.08|||<|0.001|TWO_SIDED|95.0|-4.83|-1.33|||Mixed Models Analysis|||The endpoint was analysed using mixed model for repeated measures (MMRM) model including treatment group, week, interaction between treatment and time, baseline value, and baseline weight group as fixed factors. Within participant covariance was estimated by an unstructured covariance matrix. Treatment groups were defined as randomised treatment.||-1.33|-4.83|<0.001
71014340|NCT03671746|141535069|SUPERIORITY||||||=|0.564|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).|Group-level summary statistics were calculated for demographic and clinical variables, and differences between groups were evaluated using two-sample t-tests for quantitative measures and Fisher's exact tests for categorical measures, as appropriate. Time and group comparisons for each cytokine were made using linear mixed models, with and without adjusting for selected covariates. Patient demographic variables and clinical outcomes of interest were considered for inclusion as covariates in each model but were only retained if they significantly improved the model. Linear mixed models were log-transformed, double-log-transformed, or square-root-transformed to correct for right skewness, as appropriate. Likelihood ratio testing and Akaike information criterion were used to select appropriate covariance structures in each case. All analyses were completed in SAS 9.4 (SAS Institute Inc.; Cary, NC, USA).|||=0.564
71014341|NCT03671746|141535070|SUPERIORITY||||||=|0.118|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).|Group-level summary statistics were calculated for demographic and clinical variables, and differences between groups were evaluated using two-sample t-tests for quantitative measures and Fisher's exact tests for categorical measures, as appropriate. Time and group comparisons for each cytokine were made using linear mixed models, with and without adjusting for selected covariates. Patient demographic variables and clinical outcomes of interest were considered for inclusion as covariates in each model but were only retained if they significantly improved the model. Linear mixed models were log-transformed, double-log-transformed, or square-root-transformed to correct for right skewness, as appropriate. Likelihood ratio testing and Akaike information criterion were used to select appropriate covariance structures in each case. All analyses were completed in SAS 9.4 (SAS Institute Inc.; Cary, NC, USA).|||=0.118
71014342|NCT03671746|141535071|SUPERIORITY|||||||0.215|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).|Group-level summary statistics were calculated for demographic and clinical variables, and differences between groups were evaluated using two-sample t-tests for quantitative measures and Fisher's exact tests for categorical measures, as appropriate. Time and group comparisons for each cytokine were made using linear mixed models, with and without adjusting for selected covariates. Patient demographic variables and clinical outcomes of interest were considered for inclusion as covariates in each model but were only retained if they significantly improved the model. Linear mixed models were log-transformed, double-log-transformed, or square-root-transformed to correct for right skewness, as appropriate. Likelihood ratio testing and Akaike information criterion were used to select appropriate covariance structures in each case. All analyses were completed in SAS 9.4 (SAS Institute Inc.; Cary, NC, USA).|||0.215
71029295|NCT01046253|141566125|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.5|||||TWO_SIDED|90.0|93.3|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104|93.3|
71048957|NCT02944383|141606117|SUPERIORITY||Median Difference (Net)|-11.39||||0.027|TWO_SIDED|95.0|-28.81|2.08||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||2.08|-28.81|0.0270
71014343|NCT03671746|141535072|SUPERIORITY||||||=|0.043|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).|Group-level summary statistics were calculated for demographic and clinical variables, and differences between groups were evaluated using two-sample t-tests for quantitative measures and Fisher's exact tests for categorical measures, as appropriate. Time and group comparisons for each cytokine were made using linear mixed models, with and without adjusting for selected covariates. Patient demographic variables and clinical outcomes of interest were considered for inclusion as covariates in each model but were only retained if they significantly improved the model. Linear mixed models were log-transformed, double-log-transformed, or square-root-transformed to correct for right skewness, as appropriate. Likelihood ratio testing and Akaike information criterion were used to select appropriate covariance structures in each case. All analyses were completed in SAS 9.4 (SAS Institute Inc.; Cary, NC, USA).|||=0.043
71014344|NCT03671746|141535073|SUPERIORITY||||||=|0.617|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).|Group-level summary statistics were calculated for demographic and clinical variables, and differences between groups were evaluated using two-sample t-tests for quantitative measures and Fisher's exact tests for categorical measures, as appropriate. Time and group comparisons for each cytokine were made using linear mixed models, with and without adjusting for selected covariates. Patient demographic variables and clinical outcomes of interest were considered for inclusion as covariates in each model but were only retained if they significantly improved the model. Linear mixed models were log-transformed, double-log-transformed, or square-root-transformed to correct for right skewness, as appropriate. Likelihood ratio testing and Akaike information criterion were used to select appropriate covariance structures in each case. All analyses were completed in SAS 9.4 (SAS Institute Inc.; Cary, NC, USA).|||=0.617
71014345|NCT03671746|141535075|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).|Group-level summary statistics were calculated for demographic and clinical variables, and differences between groups were evaluated using two-sample t-tests for quantitative measures and Fisher's exact tests for categorical measures, as appropriate. Time and group comparisons for each cytokine were made using linear mixed models, with and without adjusting for selected covariates. Patient demographic variables and clinical outcomes of interest were considered for inclusion as covariates in each model but were only retained if they significantly improved the model. Linear mixed models were log-transformed, double-log-transformed, or square-root-transformed to correct for right skewness, as appropriate. Likelihood ratio testing and Akaike information criterion were used to select appropriate covariance structures in each case. All analyses were completed in SAS 9.4 (SAS Institute Inc.; Cary, NC, USA).|||<0.05
71014346|NCT00056472|141535128|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28|||<|0.001||95.0|1.12|1.47|||Regression, Logistic|||Predicting remission rates of 40% in combination therapy and 20% in monotherapy subjects, 260 subjects randomized into the two treatment groups would provide \>80% power at a two-tailed alpha level of .05. Treatment efficacy was compared between groups based on intent-to-treat analyses for the longitudinal binary outcome of remission using mixed effects logistic regression with a random intercept that included treatment and time as fixed effects and a treatment by time interaction effect.||1.47|1.12|<.001
71014347|NCT00056472|141535129|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||The p-value is for the overall mean CGI-S score compared to baseline.|Mixed Models Analysis|This was a longitudinal analysis of CGI-S scores compared to baseline.||Intent-to-treat changes in global improvement from week to week compared to baseline (CGI-S) over the course of the trial using longitudinal mixed effects linear regression models. The null hypothesis is that there is no difference in overall change in CGI-S.||||.02
71014348|NCT00056472|141535130|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for the overall mean across all time points between each treatment group.|Mixed Models Analysis|||Intent-to-treat between group comparison using longitudinal mixed effects regression.||||<.001
71014349|NCT00931515|141535131|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
71014350|NCT04196023|141535144|SUPERIORITY|||||||0.2||||||p-value was calculated using GLM. Statistical significance was determined using an alpha level of 0.05.|general linear model|adjusted for age, sex, education and baseline overall MoCA score||||||0.20
71014351|NCT04196023|141535145|SUPERIORITY|||||||0.9||||||p-value was calculated using GLM model. Statistical significance was determined using an alpha level of 0.05.|general linear model|GLM model additionally adjusting for age, sex, education and baseline level.||||||0.90
71014352|NCT04196023|141535146|SUPERIORITY|||||||0.01||||||p-value was calculated using GLM model. Statistical significance was determined using an alpha level of 0.05.|general linear model|GLM model additionally adjusting for age, sex, education and baseline level.||||||0.01
70929709|NCT03331835|141356740|SUPERIORITY||Mean Difference (Net)|-16.36|||<|0.001|TWO_SIDED|95.0|-23.03|-9.68|||Mixed Models Analysis|||The endpoint was analysed using mixed model for repeated measures (MMRM) model including treatment group, week, interaction between treatment and time, baseline value, and baseline weight group as fixed factors. Within participant covariance was estimated by an unstructured covariance matrix. Treatment groups were defined as randomised treatment.||-9.68|-23.03|<0.001
70941537|NCT03722485|141383820|SUPERIORITY|||||||0.6322|||||||Fisher Exact|||||||0.6322
71104356|NCT02757768|141715915|SUPERIORITY||LS Mean of Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.31||0.372|TWO_SIDED|95.0|-0.89|0.34|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.34|-0.89|0.372
71104357|NCT02757768|141715915|SUPERIORITY||LS Mean of Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.3||0.272|TWO_SIDED|95.0|-0.92|0.26|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.26|-0.92|0.272
70929710|NCT03331835|141356741|SUPERIORITY||Mean Difference (Net)|-8.91|||<|0.001|TWO_SIDED|95.0|-13.0|-4.81|||Mixed Models Analysis|||The endpoint was analysed using mixed model for repeated measures (MMRM) model including treatment group, week, interaction between treatment and time, baseline value, and baseline weight group as fixed factors. Within participant covariance was estimated by an unstructured covariance matrix. Treatment groups were defined as randomised treatment.||-4.81|-13.00|<0.001
71104358|NCT02757768|141715916|SUPERIORITY||LS Mean of Difference|-1.75|STANDARD_ERROR_OF_MEAN|1.3||0.179|TWO_SIDED|95.0|-4.29|0.8|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.80|-4.29|0.179
71104359|NCT02757768|141715916|SUPERIORITY||LS Mean of Difference|-3.84|STANDARD_ERROR_OF_MEAN|1.41||0.006|TWO_SIDED|95.0|-6.6|-1.08|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-1.08|-6.60|0.006
71104360|NCT02757768|141715916|SUPERIORITY||LS Mean of Difference|-2.9|STANDARD_ERROR_OF_MEAN|1.51||0.055|TWO_SIDED|95.0|-5.86|0.06|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.06|-5.86|0.055
71104361|NCT02757768|141715916|SUPERIORITY||LS Mean of Difference|-2.11|STANDARD_ERROR_OF_MEAN|1.48||0.154|TWO_SIDED|95.0|-5.02|0.8|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.80|-5.02|0.154
71104362|NCT02757768|141715917|SUPERIORITY||LS Mean of Difference|-1.35|STANDARD_ERROR_OF_MEAN|1.13||0.233|TWO_SIDED|95.0|-3.57|0.87|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.87|-3.57|0.233
71104363|NCT02757768|141715917|SUPERIORITY||LS Mean of Difference|0.46|STANDARD_ERROR_OF_MEAN|1.2||0.698|TWO_SIDED|95.0|-1.89|2.82|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||2.82|-1.89|0.698
71104364|NCT02757768|141715917|SUPERIORITY||LS Mean of Difference|0.89|STANDARD_ERROR_OF_MEAN|1.28||0.486|TWO_SIDED|95.0|-1.62|3.4|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.40|-1.62|0.486
71104365|NCT02757768|141715917|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|1.26||0.968|TWO_SIDED|95.0|-2.52|2.42|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||2.42|-2.52|0.968
71104366|NCT02757768|141715918|SUPERIORITY||LS Mean of Difference|-1.89|STANDARD_ERROR_OF_MEAN|1.36||0.165|TWO_SIDED|95.0|-4.56|0.78|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.78|-4.56|0.165
71104367|NCT02757768|141715918|SUPERIORITY||LS Mean of Difference|0.76|STANDARD_ERROR_OF_MEAN|1.41||0.592|TWO_SIDED|95.0|-2.02|3.54|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.54|-2.02|0.592
71104368|NCT02757768|141715918|SUPERIORITY||LS Mean of Difference|0.9|STANDARD_ERROR_OF_MEAN|1.54||0.559|TWO_SIDED|95.0|-2.12|3.92|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.92|-2.12|0.559
71104369|NCT02757768|141715918|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|1.51||0.985|TWO_SIDED|95.0|-2.94|3.0|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.00|-2.94|0.985
71104370|NCT02757768|141715919|SUPERIORITY||LS Mean of Difference|-1.82|STANDARD_ERROR_OF_MEAN|1.29||0.161|TWO_SIDED|95.0|-4.35|0.72|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.72|-4.35|0.161
71104371|NCT02757768|141715919|SUPERIORITY||LS Mean of Difference|0.35|STANDARD_ERROR_OF_MEAN|1.38||0.798|TWO_SIDED|95.0|-2.36|3.07|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.07|-2.36|0.798
71048958|NCT02944383|141606117|SUPERIORITY||Median Difference (Net)|-0.92||||0.5263|TWO_SIDED|95.0|-16.88|15.5||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||15.50|-16.88|0.5263
70929711|NCT03331835|141356745|SUPERIORITY||Mean Difference (Final Values)|-4.92|||<|0.001|TWO_SIDED|95.0|-6.31|-3.53|||ANCOVA|||The AUC was analysed using analysis of covariance (ANCOVA) with treatment group, baseline weight group, and the baseline PSI total score as explanatory variables. Treatment groups are defined as randomised treatment.||-3.53|-6.31|<0.001
71048959|NCT02944383|141606118|SUPERIORITY|||||||0.0345||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0345
70929712|NCT03331835|141356746|SUPERIORITY||Mean Difference (Net)|-2.57||||0.004|TWO_SIDED|95.0|-4.32|-0.82|||Mixed Models Analysis|||The endpoint is analysed by using mixed model for repeated measurements (MMRM) model including treatment group, week, interaction between treatment and time, baseline value, and baseline weight group as fixed factors. Within participant covariance was estimated by an unstructured covariance matrix. Treatment groups are defined as randomised treatment.||-0.82|-4.32|0.004
71048960|NCT02944383|141606118|SUPERIORITY|||||||0.2709||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.2709
71048961|NCT02944383|141606118|SUPERIORITY|||||||0.3255||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3255
71048962|NCT02944383|141606118|SUPERIORITY|||||||0.7391||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7391
71048963|NCT02944383|141606118|SUPERIORITY|||||||0.0808||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0808
71048964|NCT02944383|141606118|SUPERIORITY|||||||0.6509||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.6509
71048965|NCT02944383|141606119|SUPERIORITY|||||||0.0004||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0004
70929713|NCT03331835|141356747|SUPERIORITY|Estimated risk difference, 95% CI and p-value are derived from Cochran-Mantel-Haenszel (CMH) analysis stratified by weight group at baseline (\<=100 kg, \> 100 kg). Non-responder Imputation (NRI) was used to impute missing data. Treatment groups were defined as randomised treatment.|Risk Difference (RD)|40.95|||<|0.001|TWO_SIDED|95.0|28.75|53.16|||Cochran-Mantel-Haenszel|||||53.16|28.75|<0.001
71048966|NCT02944383|141606119|SUPERIORITY|||||||0.0412||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0412
71048967|NCT02944383|141606119|SUPERIORITY|||||||0.1937||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1937
71048968|NCT02944383|141606119|SUPERIORITY|||||||0.474||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4740
71048969|NCT02944383|141606119|SUPERIORITY||Median Difference (Net)|-14.32||||0.0116|TWO_SIDED|95.0|-34.13|3.89||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||3.89|-34.13|0.0116
71048970|NCT02944383|141606119|SUPERIORITY||Median Difference (Net)|-3.66||||0.1109|TWO_SIDED|95.0|-23.85|14.26||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||14.26|-23.85|0.1109
71104372|NCT02757768|141715919|SUPERIORITY||LS Mean of Difference|1.17|STANDARD_ERROR_OF_MEAN|1.42||0.408|TWO_SIDED|95.0|-1.61|3.95|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.95|-1.61|0.408
71104373|NCT02757768|141715919|SUPERIORITY||LS Mean of Difference|0.14|STANDARD_ERROR_OF_MEAN|1.39||0.919|TWO_SIDED|95.0|-2.6|2.88|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||2.88|-2.60|0.919
71104374|NCT02757768|141715920|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|1.49||0.99|TWO_SIDED|95.0|-2.94|2.91|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||2.91|-2.94|0.990
70850571|NCT02712047|141189436|OTHER||Ratio|0.68|||||TWO_SIDED|95.0|0.58|0.81|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 10, PM|||0.81|0.58|
71014353|NCT04196023|141535147|SUPERIORITY|||||||0.05||||||p-value was calculated using GLM model and false discovery rate (FDR)-adjustment. Statistical significance was determined using an alpha level of 0.05.|general linear model|GLM model additionally adjusting for age, sex, education and baseline level.||||||0.05
71048971|NCT02944383|141606120|SUPERIORITY|||||||0.0002||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0002
71048972|NCT02944383|141606120|SUPERIORITY|||||||0.0161||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0161
71048973|NCT02944383|141606120|SUPERIORITY|||||||0.3043||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3043
71048974|NCT02944383|141606120|SUPERIORITY|||||||0.4639||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4639
70850572|NCT02712047|141189436|OTHER||Ratio|0.73|||||TWO_SIDED|95.0|0.61|0.86|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 11, AM|||0.86|0.61|
71014354|NCT00489411|141535237|SUPERIORITY_OR_OTHER||Mean Difference|0.73||||0.003|TWO_SIDED|95.0|0.26|1.2|||Wilcoxon (Mann-Whitney)|||||1.20|0.26|0.003
71014355|NCT00489411|141535238|SUPERIORITY_OR_OTHER||Mean Difference|4.4|||||TWO_SIDED|95.0|0.93|7.88||||||||7.88|0.93|
71014356|NCT00489411|141535239|SUPERIORITY_OR_OTHER||Mean Difference|1.58||||0.03|TWO_SIDED|95.0|0.15|3.0|||Wilcoxon (Mann-Whitney)|||||3.00|0.15|0.03
71014357|NCT00489411|141535240|SUPERIORITY_OR_OTHER||Mean difference|1.01|||||TWO_SIDED|95.0|0.36|1.65||||||||1.65|0.36|
71014358|NCT01283009|141535241|SUPERIORITY||Odds Ratio (OR)|0.9||||0.635|TWO_SIDED|95.0|0.58|1.4|||Mantel Haenszel|||||1.40|0.58|0.635
71014359|NCT04436497|141535242|SUPERIORITY||Disease Rate Ratio|1.08|STANDARD_DEVIATION|0.11|||TWO_SIDED|95.0|0.874|1.307||Posterior probability that the disease rate ratio (DRR) is less than 1 (i.e. zilucoplan slowed progression) was 0.2418. NOTE: p-value is not provided for Bayesian model.|Bayesian shared-parameter model|A Bayesian shared-parameter model of change in disease severity as measured by ALSFRS-R total score and mortality.|"DDR \<1 imply slowing of disease progression by zilucoplan relative to placebo. Note: reported Confidence Interval is actually a Bayesian credible interval."||The DRR parameter for active treatment represents the relative change to the rate of decline of ALSFRS-R and the rate of mortality of treated participant relative to a placebo participant. The estimated DRR can also be interpreted as the average rate of decline in function and mortality. The model includes covariates for baseline use of edaravone, baseline use of riluzole, months since onset of symptoms, and pre-baseline slope of ALSFRS-R, and random effects for regimen and participant-specific slopes.|1.307|0.874|
71014360|NCT04436497|141535244|SUPERIORITY||Mean Difference (Net)|-1.09|STANDARD_ERROR_OF_MEAN|1.819||0.5495|TWO_SIDED|95.0|-4.66|2.48|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Zilucoplan 24-week change from baseline relative to placebo 24-week change from baseline.|||2.48|-4.66|0.5495
71014361|NCT04436497|141535245|SUPERIORITY||Mean Difference (Net)|-1.04|STANDARD_ERROR_OF_MEAN|3.409||0.7602|TWO_SIDED|95.0|-7.73|5.65|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Zilucoplan 24-week change from baseline relative to placebo 24-week change from baseline.|||5.65|-7.73|0.7602
71014362|NCT04436497|141535246|SUPERIORITY|||||||0.6891|||||||Log Rank|||||||0.6891
71048975|NCT02944383|141606120|SUPERIORITY|||||||0.021||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0210
71048976|NCT02944383|141606120|SUPERIORITY|||||||0.0992||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0992
71048977|NCT02944383|141606121|SUPERIORITY|||||||0.1512||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1512
71048978|NCT02944383|141606121|SUPERIORITY|||||||0.84||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.8400
71104375|NCT02757768|141715920|SUPERIORITY||LS Mean of Difference|0.92|STANDARD_ERROR_OF_MEAN|1.55||0.554|TWO_SIDED|95.0|-2.12|3.96|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.96|-2.12|0.554
71104376|NCT02757768|141715920|SUPERIORITY||LS Mean of Difference|1.53|STANDARD_ERROR_OF_MEAN|1.63||0.348|TWO_SIDED|95.0|-1.67|4.73|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||4.73|-1.67|0.348
71104377|NCT02757768|141715920|SUPERIORITY||LS Mean of Difference|0.25|STANDARD_ERROR_OF_MEAN|1.6||0.876|TWO_SIDED|95.0|-2.89|3.38|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.38|-2.89|0.876
70850573|NCT02712047|141189436|OTHER||Ratio|0.73|||||TWO_SIDED|95.0|0.61|0.86|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 11, PM|||0.86|0.61|
71014363|NCT00694070|141535247|NON_INFERIORITY_OR_EQUIVALENCE|"The null and alternative hypotheses for these tests will have the form:~Ho: Pr{Success} \< Po vs. Ha: Pr{Success} ≥ Po. Critical values for numbers of successes were computed to give approximately a 90% chance of rejecting Ho in favor of the alternative (non-inferiority) if the true probability of success is at least Po. For Po = 80%, with n=51, critical number is 38. With this critical value and sample size, the power to reject Ho is approximately 87.43%."||||||0.0421|||||||Exact binomial test|||||||0.0421
71014364|NCT00694070|141535248|NON_INFERIORITY_OR_EQUIVALENCE|"The null and alternative hypotheses for these tests will have the form:~Ho: Pr{Success} \< Po vs. Ha: Pr{Success} ≥ Po. Critical values for numbers of successes were computed to give approximately a 90% chance of rejecting Ho in favor of the alternative (non-inferiority) if the true probability of success is at least Po. For Po = 95%, with n=51, critical number is 47. With this critical value and sample size, the power to reject Ho is approximately 88.96%."||||||0.0309|||||||Exact binomial test|||||||0.0309
71014365|NCT00694070|141535249|NON_INFERIORITY_OR_EQUIVALENCE|"The null and alternative hypotheses for these tests will have the form:~Ho: Pr{Success} \< Po vs. Ha: Pr{Success} ≥ Po. Critical values for numbers of successes were computed to give approximately a 90% chance of rejecting Ho in favor of the alternative (non-inferiority) if the true probability of success is at least Po. For Po = 90%, with n=51, critical number is 43. With this critical value and sample size, the power to reject Ho is approximately 93.57%."||||||0.0309|||||||Exact binomial test|||||||0.0309
71014366|NCT04640168|141535250|SUPERIORITY|||||||0.909|||||||Chi-squared|||||||0.909
71014367|NCT04640168|141535267|SUPERIORITY||Risk Difference (RD)|7.7|||||TWO_SIDED|95.0|1.8|13.4||||||||13.4|1.8|
71014368|NCT04640168|141535268|SUPERIORITY||Risk Difference (RD)|0.6|||||TWO_SIDED|95.0|-4.3|5.5||||||||5.5|-4.3|
71014369|NCT04640168|141535286|SUPERIORITY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.8|1.27||||||||1.27|0.80|
71048979|NCT02944383|141606121|SUPERIORITY|||||||0.0244||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0244
71048980|NCT02944383|141606121|SUPERIORITY|||||||0.1803||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1803
71048981|NCT02944383|141606121|SUPERIORITY||Median Difference (Net)|-24.41||||0.0307|TWO_SIDED|95.0|-42.73|-9.94||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-9.94|-42.73|0.0307
71048982|NCT02944383|141606121|SUPERIORITY||Median Difference (Net)|-8.73||||0.5326|TWO_SIDED|95.0|-23.33|7.68||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||7.68|-23.33|0.5326
71048983|NCT02944383|141606122|SUPERIORITY|||||||0.1705||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1705
71048984|NCT02944383|141606122|SUPERIORITY|||||||0.9193||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.9193
71048985|NCT02944383|141606122|SUPERIORITY|||||||0.0224||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0224
71048986|NCT02944383|141606122|SUPERIORITY|||||||0.2387||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2387
71048987|NCT02944383|141606122|SUPERIORITY|||||||0.06||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0600
71048988|NCT02944383|141606122|SUPERIORITY|||||||0.6878||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.6878
71048989|NCT02944383|141606123|SUPERIORITY|||||||0.0298||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0298
71014370|NCT04640168|141535287|SUPERIORITY||Risk Difference (RD)|-0.03|||||TWO_SIDED|95.0|-0.09|0.02||||||||0.02|-0.09|
70850574|NCT02712047|141189436|OTHER||Ratio|0.72|||||TWO_SIDED|95.0|0.61|0.85|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 12, AM|||0.85|0.61|
70850575|NCT02712047|141189436|OTHER||Ratio|0.71|||||TWO_SIDED|95.0|0.6|0.84|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 12, PM|||0.84|0.60|
71014371|NCT04640168|141535288|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.94|1.23||||||||1.23|0.94|
71014372|NCT04640168|141535289|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.94|1.23||||||||1.23|0.94|
71014373|NCT04640168|141535290|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.91|1.19||||||||1.19|0.91|
71014374|NCT00276458|141535333|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.9|STANDARD_ERROR_OF_MEAN|2.7|<|0.001||95.0|-25.2|-14.5|||ANCOVA|Model terms: treatment and baseline LDL-C value|(Atorva + EZ minus Atorva)|||-14.5|-25.2|<0.001
70929714|NCT03331835|141356748|SUPERIORITY|The endpoint was analysed by using mixed model for repeated measures (MMRM) model including treatment group, week, interaction between treatment and time, baseline value, and baseline weight group as fixed factors. Within participant covariance was estimated by an unstructured covariance matrix. Treatment groups were defined as randomised treatment.|Mean Difference (Net)|-1.72||||0.028|TWO_SIDED|95.0|-3.24|-0.19|||Mixed Models Analysis|||||-0.19|-3.24|0.028
70929715|NCT03314740|141356790|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.265|TWO_SIDED|90.0|0.5|1.14|||cox model|||||1.14|0.5|0.265
70929716|NCT03314740|141356790|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.904|TWO_SIDED|90.0|0.68|1.55|||cox- model|||||1.55|0.68|0.904
70929717|NCT02367040|141356804|SUPERIORITY|PFS was evaluated with the stratified log-rank test. HR and 95% CI were based on stratified Cox Regression Model.|Hazard Ratio (HR)|0.52||||2e-06|TWO_SIDED|95.0|0.393|0.688||1-sided p-value|Log Rank|||At primary completion date||0.688|0.393|0.000002
70929718|NCT02367040|141356804|SUPERIORITY|PFS was evaluated with the stratified log-rank test. HR and 95% CI were based on stratified Cox Regression Model.|Hazard Ratio (HR)|0.557||||3e-06|TWO_SIDED|95.0|0.431|0.722||1-sided p-value|Log Rank|||At 2-year follow-up cut-off date||0.722|0.431|0.000003
70929719|NCT02367040|141356805|SUPERIORITY|P-value from Cochran-Mantel-Haenszel (CMH) test stratified|Difference in ORR|32.99|||<|1e-06|TWO_SIDED|95.0|23.95|42.03||1-sided p-value|Cochran-Mantel-Haenszel|||At primary completion date||42.03|23.95|<0.000001
70929720|NCT02367040|141356805|SUPERIORITY|P-value from Cochran-Mantel-Haenszel (CMH) test stratified|Difference in ORR|30.67|||<|1e-06|TWO_SIDED|95.0|21.63|39.72||1-sided p-value|Cochran-Mantel-Haenszel|||At 2-year follow-up cut-off date||39.72|21.63|<0.000001
70929721|NCT02367040|141356806|SUPERIORITY|P-value from Cochran-Mantel-Haenszel (CMH) test stratified|Difference in CRR|19.27|||<|1e-06|TWO_SIDED|95.0|11.57|26.96||1-sided p-value|Cochran-Mantel-Haenszel|||At primary completion date||26.96|11.57|<0.000001
70929722|NCT02367040|141356806|SUPERIORITY|P-value from Cochran-Mantel-Haenszel (CMH) test stratified|Difference in CRR|18.92||||1e-06|TWO_SIDED|95.0|11.11|26.73||1-sided p-value|Cochran-Mantel-Haenszel|||At 2-year follow-up cut-off date||26.73|11.11|0.000001
70929723|NCT02367040|141356807|SUPERIORITY|DOR was evaluated with the stratified log-rank test. HR and 95% CI were based on stratified Cox Regression Model.|Kaplan-Meier estimates|0.7||||0.030371|TWO_SIDED|95.0|0.481|1.018||1-sided p-value|Log Rank|||At primary completion date||1.018|0.481|0.030371
70929724|NCT02367040|141356807|SUPERIORITY|DOR was evaluated with the stratified log-rank test. HR and 95% CI were based on stratified Cox Regression Model.|Hazard Ratio (HR)|0.761||||0.051976|TWO_SIDED|95.0|0.547|1.059||1-sided p-value|Log Rank|||At 2-year follow-up cut-off date||1.059|0.547|0.051976
70929725|NCT02367040|141356808|SUPERIORITY|P-value from Cochran-Mantel-Haenszel (CMH) test stratified|Difference in DCR|4.43||||0.097339|TWO_SIDED|95.0|-2.26|11.12||1-sided p-value|Cochran-Mantel-Haenszel|||At primary completion date||11.12|-2.26|0.097339
70929726|NCT02367040|141356808|SUPERIORITY|P-value from Cochran-Mantel-Haenszel (CMH) test stratified|Difference in DCR|4.43||||0.097339|TWO_SIDED|95.0|-2.26|11.12||1-sided p-value|Cochran-Mantel-Haenszel|||At 2-year follow-up cut-off date||11.12|-2.26|0.097339
70929727|NCT02367040|141356809|SUPERIORITY|TTP was evaluated with the stratified log-rank test. HR and 95% CI were based on Cox Regression Model.|Hazard Ratio (HR)|0.476|||<|1e-06|TWO_SIDED|95.0|0.357|0.635||1-sided p-value|Log Rank|||At primary completion date||0.635|0.357|<.000001
70929728|NCT02367040|141356809|SUPERIORITY|TTP was evaluated with the stratified log-rank test. HR and 95% CI were based on Cox Regression Model.|Hazard Ratio (HR)|0.505|||<|1e-06|TWO_SIDED|95.0|0.387|0.659||1-sided p-value|Log Rank|||At 2-year follow-up cut-off date||0.659|0.387|<.000001
70929729|NCT02367040|141356811|SUPERIORITY|Time to deterioration in DRS-P was evaluated with the stratified log-rank test. HR and 95% CI were based on Cox Regression Model.|Hazard Ratio (HR)|1.06||||0.69261|TWO_SIDED|95.0|0.843|1.331||1-sided p-value|Log Rank|||At primary completion date||1.331|0.843|0.692610
70929730|NCT02367040|141356811|SUPERIORITY|Time to deterioration in DRS-P was evaluated with the stratified log-rank test. HR and 95% CI were based on Cox Regression Model.|Hazard Ratio (HR)|1.047||||0.661145|TWO_SIDED|95.0|0.841|1.302||1-sided p-value|Log Rank|||At 2-year follow-up cut-off date||1.302|0.841|0.661145
70929731|NCT02367040|141356812|SUPERIORITY|Time to improvement in DRS-P was evaluated with the stratified log-rank test. HR and 95% CI were based on Cox Regression Model.|Hazard Ratio (HR)|0.996||||0.510038|TWO_SIDED|95.0|0.732|1.355||1-sided p-value|Log Rank|||At primary completion date||1.355|0.732|0.510038
70929732|NCT02367040|141356812|SUPERIORITY|Time to improvement in DRS-P was evaluated with the stratified log-rank test. HR and 95% CI were based on Cox Regression Model.|Hazard Ratio (HR)|1.036||||0.40597|TWO_SIDED|95.0|0.768|1.398||1-sided p-value|Log Rank|||At 2-year follow-up cut-off date||1.398|0.768|0.405970
70929733|NCT03421340|141356843|NON_INFERIORITY|Non-Inferiority Margin of 10%|Risk Difference (RD)|1.8||||0.029|TWO_SIDED||||||exact|||||||0.029
70929734|NCT03421340|141356844|SUPERIORITY|Not powered|Risk Difference (RD)|-1.7|||||TWO_SIDED|95.0|-8.0|4.1||||||||4.1|-8|
70929735|NCT03421340|141356845|SUPERIORITY||Median Difference (Net)|133.0|||||TWO_SIDED|95.0|120.0|143.0||||||||143|120|
70929736|NCT03421340|141356846|SUPERIORITY||Median Difference (Final Values)|-10.2|||||TWO_SIDED|95.0|-11.6|-7.5||||||||-7.5|-11.6|
70929737|NCT05736458|141356934|SUPERIORITY||Mean Difference (Final Values)|0.45||||0.66|TWO_SIDED||||||t-test, 2 sided|||Of the 23 participants who completed all study procedures, 2 participant's data was unusable for this analysis. Statistics are from paired 2 tailed t-test comparing pre-rTMS 2-back percent accuracy scores for participant's high and low controllability target.||||0.66
70929738|NCT05736458|141356935|SUPERIORITY||Mean Difference (Final Values)|1.94||||0.43|TWO_SIDED||||||t-test, 2 sided|df = 19||Statistics are from 2-tailed t-test comparing pre-rTMS to post-rTMS 2-back accuracy scores for a high controllability TMS target. Alternative hypothesis: true mean is not equal to 0.||||0.43
71014375|NCT00276458|141535334|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|2.1||0.273||95.0|-1.9|6.6|||ANCOVA|Model terms: treatment and baseline HDL-C value|(Atorva + EZ minus Atorva)|||6.6|-1.9|0.273
71014376|NCT00276458|141535335|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.4|STANDARD_ERROR_OF_MEAN|2.4|<|0.001||95.0|-21.2|-11.7|||ANCOVA|Model terms: treatment and baseline non-HDL-C value|(Atorva + EZ minus Atorva)|||-11.7|-21.2|<0.001
71104378|NCT02757768|141715921|SUPERIORITY||LS Mean of Difference|-1.1|STANDARD_ERROR_OF_MEAN|1.05||0.293|TWO_SIDED|95.0|-3.16|0.95|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.95|-3.16|0.293
71014377|NCT00276458|141535336|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-15.8|-8.6|||ANCOVA|Model terms: treatment and baseline Total-C value|(Atorva + EZ minus Atorva)|||-8.6|-15.8|<0.001
71014378|NCT00276458|141535337|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-8.9||||0.159||95.0|-17.7|-0.4||ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment and baseline triglycerides value|Nonparametric ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment and baseline triglycerides value.|"The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic.~(Atorva + EZ minus Atorva)"|||-0.4|-17.7|0.159
71014379|NCT00276458|141535338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.7|STANDARD_ERROR_OF_MEAN|2.1|<|0.001||95.0|-17.8|-9.6|||ANCOVA|Model terms: treatment and baseline Apo B value|(Atorva + EZ minus Atorva)|||-9.6|-17.8|<0.001
71014380|NCT00276458|141535339|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|1.6||0.681||95.0|-3.9|2.6|||ANCOVA|Model terms: treatment and baseline Apo A-I value|(Atorva + EZ minus Atorva)|||2.6|-3.9|0.681
71014381|NCT00276458|141535340|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.1|STANDARD_ERROR_OF_MEAN|2.2|<|0.001||95.0|-17.5|-8.7|||ANCOVA|Model terms: treatment and baseline Total-C:HDL-C value|(Atorva + EZ minus Atorva)|||-8.7|-17.5|<0.001
71014382|NCT00276458|141535341|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.9|STANDARD_ERROR_OF_MEAN|2.8|<|0.001||95.0|-26.5|-15.3|||ANCOVA|Model terms: treatment and baseline LDL-C:HDL-C value|(Atorva + EZ minus Atorva)|||-15.3|-26.5|<0.001
71014383|NCT00276458|141535342|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.1|STANDARD_ERROR_OF_MEAN|2.4|<|0.001||95.0|-17.9|-8.3|||ANCOVA|Model terms: treatment and baseline Apo B:Apo A-I value|(Atorva + EZ minus Atorva)|||-8.3|-17.9|<0.001
71014384|NCT00276458|141535343|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.3|STANDARD_ERROR_OF_MEAN|3.0|<|0.001||95.0|-23.2|-11.4|||ANCOVA|Model terms: treatment and baseline non-HDL-C:HDL-C value|(Atorva + EZ minus Atorva)|||-11.4|-23.2|<0.001
71014385|NCT00276458|141535344|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5||||0.841||95.0|-23.8|28.8|||Longitudinal Data Analysis (LDA)|LDA method of Liang and Zeger with model terms: treatment, time, and the interaction of time by treatment|"Data for analysis was transformed by the natural log and the difference in geometric mean % change from BL calculated based on the difference in the back-transformed least squares means.~(Atorva + EZ minus Atorva)"|||28.8|-23.8|0.841
71014386|NCT00276458|141535345|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.3||||0.839||95.0|-26.1|8.3|||Nonparametric ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment and baseline CRP value|"The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic.~(Atorva + EZ minus Atorva)"|||8.3|-26.1|0.839
71014387|NCT00276458|141535346|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.6|||<|0.001||95.0|3.8|19.47|||Regression, Logistic|Model terms: treatment and baseline LDL-C value|Estimated ratio is the predictive odds of attaining LDL-C target on Atorva + EZ versus Atorva.|||19.47|3.80|<0.001
71014388|NCT00750373|141535347|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.1|||<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||We estimated that a sample size of 74 patients would provide 80% power to detect a significant difference with respect to the primary end point at the 2-sided significance level of 0.05, assuming that the in-hospital event rate would be 23% in the conventional treatment group and 3% in the early surgery group.||||<0.05
71014389|NCT02276274|141535382|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.0164|||||TWO_SIDED|90.0|-0.0592|0.0264|||||Analysis of variance (ANOVA) was performed on log-transformed values of AUC (0-72) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.0264|-0.0592|
71014390|NCT02276274|141535383|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.0164|||||TWO_SIDED|90.0|-0.0592|0.0264|||||ANOVA was performed on log-transformed values of AUC (0-tlqc) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.0264|-0.0592|
71014391|NCT02276274|141535384|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.1182|||||TWO_SIDED|90.0|-0.0405|0.2769|||||ANOVA was performed on log-transformed values of Cmax with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.2769|-0.0405|
71014392|NCT02276274|141535386|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.0139|||||TWO_SIDED|90.0|-0.0598|0.032|||||ANOVA was performed on log-transformed values of AUC (0-inf) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.0320|-0.0598|
71014393|NCT02276274|141535401|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.014|||||TWO_SIDED|90.0|-0.0918|0.0638|||||ANOVA was performed on log-transformed values of AUC (0-48) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.0638|-0.0918|
71014394|NCT02276274|141535402|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.0164|||||TWO_SIDED|90.0|-0.0934|0.0605|||||ANOVA was performed on log-transformed values of AUC (0-tlqc) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.0605|-0.0934|
71014395|NCT02276274|141535404|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.1518|||||TWO_SIDED|90.0|-0.2356|-0.068|||||ANOVA was performed on log-transformed values of Cmax with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||-0.0680|-0.2356|
71014396|NCT02276274|141535406|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.0179|||||TWO_SIDED|90.0|-0.095|0.0591|||||ANOVA was performed on log-transformed values of AUC (0-inf) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.0591|-0.0950|
71104379|NCT02757768|141715921|SUPERIORITY||LS Mean of Difference|-0.32|STANDARD_ERROR_OF_MEAN|1.12||0.773|TWO_SIDED|95.0|-2.52|1.87|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||1.87|-2.52|0.773
71014397|NCT01015118|141535512|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0239|TWO_SIDED|95.0|0.72|0.98|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|Hazard ratio (HR), Confidence Interval (CI) and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level Area under curve 5 (AUC5) vs. Area under curve 6 (AUC6).||0.98|0.72|0.0239
70850576|NCT02712047|141189436|OTHER||Ratio|0.72|||||TWO_SIDED|95.0|0.61|0.86|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 13, AM|||0.86|0.61|
71014398|NCT01015118|141535513|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.0286|TWO_SIDED|95.0|0.75|0.98|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|Hazard ratio (HR), Confidence Interval (CI) and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).||0.98|0.75|0.0286
71014399|NCT01015118|141535514|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0186|TWO_SIDED|95.0|0.72|0.97|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|HR, CI and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).||0.97|0.72|0.0186
71014400|NCT01015118|141535515|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.0256|TWO_SIDED|95.0|0.74|0.98|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|HR, CI and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).||0.98|0.74|0.0256
71014401|NCT01015118|141535516|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.8653|TWO_SIDED|95.0|0.83|1.17|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|HR, CI and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).||1.17|0.83|0.8653
71014402|NCT01015118|141535517|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.0749|TWO_SIDED|95.0|0.77|1.01|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|HR, CI and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).||1.01|0.77|0.0749
71014403|NCT01015118|141535518|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.349|TWO_SIDED|95.0|0.81|1.82|||Regression, Logistic||An odds ratio \>1 favours nintedanib.|Odds ratio and p-value are obtained from logistic regression model adjusting for, macroscopic residual postoperative tumour (yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).||1.82|0.81|0.3490
71014404|NCT01015118|141535519|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.29|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|3.88|6.69|||Mixed effect growth curve model|Mixed-effects growth curve models (longitudinal models) with the average profile over time for each endpoint described by a piecewise linear model.|Mean difference presented is the Adjusted mean difference. Difference calculated as nintedanib minus placebo. High values represent a worse level of symptoms.|Adjusted for the stratification factors macroscopic residual postoperative tumour at baseline (yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) stage (IIB-III vs IV), and carboplatin level (AUC5 vs. AUC6).||6.69|3.88|<0.0001
71014405|NCT01015118|141535520|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.88|STANDARD_ERROR_OF_MEAN|0.75||0.0124|TWO_SIDED|95.0|-3.35|-0.41|||Mixed effect growth curve model|Mixed-effects growth curve models (longitudinal models) with the average profile over time for each endpoint described by a piecewise linear model.|Mean difference calculated is the Adjusted mean. High values represent a better level of functioning. Difference calculated as nintedanib minus placebo.|Adjusted for the stratification factors macroscopic residual postoperative tumour at baseline (yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) stage (IIB-III vs IV), and carboplatin level (AUC5 vs. AUC6).||-0.41|-3.35|0.0124
71014406|NCT03522506|141535521|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The least squares mean (LSM) sleep latency for each treatment and the associated standard error and 95% confidence interval (CI) was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|Least square mean difference|20.06|||<|0.001|TWO_SIDED|95.0|13.35|26.77|||Linear mixed effect model|||||26.77|13.35|<0.001
71014407|NCT03522506|141535521|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|24.35|||<|0.001|TWO_SIDED|95.0|17.64|31.06|||Linear mixed effect model|||||31.06|17.64|<0.001
71014408|NCT03522506|141535521|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM Difference|19.89|||<|0.001|TWO_SIDED|95.0|13.3|26.49|||Linear mixed effects model|||||26.49|13.30|<0.001
71048990|NCT02944383|141606123|SUPERIORITY|||||||0.0196||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0196
70850577|NCT02712047|141189436|OTHER||Ratio|0.78|||||TWO_SIDED|95.0|0.66|0.93|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 13, PM|||0.93|0.66|
71014409|NCT03522506|141535531|SUPERIORITY|14 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.2||||0.664|TWO_SIDED|95.0|-1.13|0.73|||Linear mixed effect model|||||0.73|-1.13|0.664
71014410|NCT03522506|141535531|SUPERIORITY|14 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|0.24||||0.605|TWO_SIDED|95.0|-0.69|1.17|||Linear mixed effect model|||||1.17|-0.69|0.605
71104380|NCT02757768|141715921|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|1.12||0.94|TWO_SIDED|95.0|-2.28|2.11|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||2.11|-2.28|0.940
71104381|NCT02757768|141715921|SUPERIORITY||LS Mean of Difference|-0.71|STANDARD_ERROR_OF_MEAN|1.1||0.516|TWO_SIDED|95.0|-2.86|1.44|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||1.44|-2.86|0.516
71104382|NCT02757768|141715922|SUPERIORITY|||||||0.4591|||||||t-test, 2 sided|Statistical comparisons were be made using 2-sided tests at α = 0.05 significance level.||Week 4 Placebo vs. Mirabegron.||||0.4591
71104383|NCT02757768|141715922|SUPERIORITY|||||||0.4073|||||||t-test, 2 sided|Statistical comparisons were be made using 2-sided tests at α = 0.05 significance level.||Week 8 Placebo vs. Mirabegron.||||0.4073
71104384|NCT02757768|141715922|SUPERIORITY|||||||0.774|||||||t-test, 2 sided|Statistical comparisons were be made using 2-sided tests at α = 0.05 significance level.||Week 12 Placebo vs. Mirabegron.||||0.7740
71014411|NCT03522506|141535531|SUPERIORITY|14 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.26||||0.574|TWO_SIDED|95.0|-1.17|0.66|||Linear mixed effect model|||||0.66|-1.17|0.574
71014412|NCT03522506|141535531|SUPERIORITY|10 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|0.29||||0.483|TWO_SIDED|95.0|-0.53|1.11|||Linear mixed effect model|||||1.11|-0.53|0.483
71014413|NCT03522506|141535531|SUPERIORITY|10 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|0.01||||0.972|TWO_SIDED|95.0|-0.81|0.84|||Linear mixed effect model|||||0.84|-0.81|0.972
71014414|NCT03522506|141535531|SUPERIORITY|10 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.18||||0.654|TWO_SIDED|95.0|-0.99|0.63|||Linear mixed effect model|||||0.63|-0.99|0.654
71104385|NCT02757768|141715922|SUPERIORITY|||||||0.5121|||||||t-test, 2 sided|Statistical comparisons were be made using 2-sided tests at α = 0.05 significance level.||EoT Placebo vs. Mirabegron.||||0.5121
71104386|NCT02757768|141715923|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.223|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.2|0.223
71104387|NCT02757768|141715923|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.598|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.2|0.598
71104388|NCT02757768|141715923|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.312|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.3|0.312
71048991|NCT02944383|141606123|SUPERIORITY|||||||0.2219||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2219
71048992|NCT02944383|141606123|SUPERIORITY|||||||0.4078||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4078
71048993|NCT02944383|141606123|SUPERIORITY||Median Difference (Net)|-15.34||||0.0605|TWO_SIDED|95.0|-31.68|1.3||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||1.30|-31.68|0.0605
71048994|NCT02944383|141606123|SUPERIORITY||Median Difference (Net)|-4.08||||0.1768|TWO_SIDED|95.0|-19.91|7.32||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||7.32|-19.91|0.1768
71048995|NCT02944383|141606124|SUPERIORITY|||||||0.0084||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0084
71048996|NCT02944383|141606124|SUPERIORITY|||||||0.0047||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0047
71048997|NCT02944383|141606124|SUPERIORITY|||||||0.1574||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1574
71048998|NCT02944383|141606124|SUPERIORITY|||||||0.3235||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3235
71048999|NCT02944383|141606124|SUPERIORITY|||||||0.0367||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0367
71049000|NCT02944383|141606124|SUPERIORITY|||||||0.0948||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0948
71049001|NCT02944383|141606125|SUPERIORITY|||||||0.0037||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0037
71049002|NCT02944383|141606125|SUPERIORITY|||||||0.1328||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1328
71049003|NCT02944383|141606125|SUPERIORITY|||||||0.4364||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4364
71049004|NCT02944383|141606125|SUPERIORITY|||||||0.8129||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.8129
71049005|NCT02944383|141606125|SUPERIORITY||Median Difference (Net)|-15.29||||0.0347|TWO_SIDED|95.0|-36.54|2.35||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||2.35|-36.54|0.0347
71049006|NCT02944383|141606125|SUPERIORITY||Median Difference (Net)|-2.14||||0.3617|TWO_SIDED|95.0|-25.78|23.62||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||23.62|-25.78|0.3617
71049007|NCT02944383|141606126|SUPERIORITY|||||||0.0085||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0085
71049008|NCT02944383|141606126|SUPERIORITY|||||||0.2112||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.2112
71049009|NCT02944383|141606126|SUPERIORITY|||||||0.7301||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7301
71049010|NCT02944383|141606126|SUPERIORITY|||||||0.6283||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.6283
71049011|NCT02944383|141606126|SUPERIORITY|||||||0.0919||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0919
71049012|NCT02944383|141606126|SUPERIORITY|||||||0.5497||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.5497
71049013|NCT02944383|141606127|SUPERIORITY|||||||0.0009||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0009
71049014|NCT02944383|141606127|SUPERIORITY|||||||0.0351||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0351
71049015|NCT02944383|141606127|SUPERIORITY|||||||0.1561||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1561
71049016|NCT02944383|141606127|SUPERIORITY|||||||0.0268||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0268
71049017|NCT02944383|141606127|SUPERIORITY||Median Difference (Net)|-22.3||||0.0516|TWO_SIDED|95.0|-42.96|-1.67||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-1.67|-42.96|0.0516
71049018|NCT02944383|141606127|SUPERIORITY||Median Difference (Net)|-13.06||||0.0125|TWO_SIDED|95.0|-32.83|4.88||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||4.88|-32.83|0.0125
71049019|NCT02944383|141606128|SUPERIORITY|||||||0.0023||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0023
71049020|NCT02944383|141606128|SUPERIORITY|||||||0.0356||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0356
71049021|NCT02944383|141606128|SUPERIORITY|||||||0.2284||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2284
71049022|NCT02944383|141606128|SUPERIORITY|||||||0.0213||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0213
71104389|NCT02757768|141715923|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.525|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.2|0.525
71049023|NCT02944383|141606128|SUPERIORITY|||||||0.033||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0330
71049024|NCT02944383|141606128|SUPERIORITY|||||||0.0221||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0221
71049025|NCT02944383|141606129|SUPERIORITY||Median Difference (Net)|-2.67||||0.2632|TWO_SIDED|95.0|-10.17|5.67||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|VLDL||5.67|-10.17|0.2632
70929739|NCT05736458|141356935|SUPERIORITY||Mean Difference (Final Values)|6.36|||<|0.04|TWO_SIDED||||||t-test, 2 sided|df = 20||Statistics are from 2-tailed t-test comparing pre-rTMS and post-rTMS 2-back percent accuracy scores for a low controllability TMS target. Alternative hypothesis: true mean is not equal to 0.||||<0.04
70929740|NCT05736458|141356936|SUPERIORITY||Mean Difference (Final Values)|11.54|||<|0.05|TWO_SIDED||||||t-test, 2 sided|df = 11||Statistics are from 2-tailed paired t-test comparing 2-back accuracy score before and after rTMS to a high controllability target. Alternative hypothesis: true mean is not equal to 0.||||<0.05
70929741|NCT05736458|141356937|SUPERIORITY||Mean Difference (Net)|-4.42||||0.27|TWO_SIDED||||||t-test, 2 sided|df = 19||Statistics are from paired 2 tailed t-test comparing 2-back percent changes (Post-rTMS - pre-rTMS) scores for participant's high and low controllability target. Alternative hypothesis: true mean is not equal to 0.||||0.27
70929742|NCT02990338|141356938|SUPERIORITY|A closed test procedure was used to control the type I error rate meaning no further testing would be performed unless the significance level had been reached on PFS.|Hazard Ratio (HR)|0.596||||0.0005|TWO_SIDED|95.0|0.436|0.814||One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.025.|Log Rank|Stratification was based on age (\<75 years versus \>=75 years) and number of previous lines of therapy (2 or 3 versus \>3) according to IRT.|Stratification was based on age (\<75 years versus \>=75 years) and number of previous lines of therapy (2 or 3 versus \>3) according to IRT.|Confidence interval (CI) for Kaplan-Meier estimates were calculated with log-log transformation of survival function and methods of Brookmeyer and Crowley.||0.814|0.436|0.0005
70929743|NCT02990338|141356939|SUPERIORITY|A closed test procedure was used to control the type I error rate meaning no further testing would be performed unless the significance level had been reached on PFS.|||||<|0.0001||||||Threshold for statistical significance at 0.025.|Cochran-Mantel-Haenszel|One sided p-value was stratified based on age (\<75 years versus \>=75 years) and number of previous lines (2 or 3 versus \>3) according to IRT.||||||<0.0001
70929744|NCT02990338|141356943|SUPERIORITY|A closed test procedure was used to control the type I error rate meaning no further testing would be performed unless the significance level had been reached on PFS.|Hazard Ratio (HR)|0.776||||0.0319|TWO_SIDED|95.0|0.594|1.015||One-sided significance level was 0.02 using the O'Brien-Fleming alpha spending function.|Log Rank|Stratified on age (\<75 years versus \>=75 years) and number of previous lines of therapy (2 or 3 versus \> 3) according to IRT.|Stratified on age (\<75 years versus \>=75 years) and number of previous lines of therapy (2 or 3 versus \> 3) according to IRT.|||1.015|0.594|0.0319
70929745|NCT00971087|141356962|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|3D + s2D will be considered non-inferior to 2D FFDM if the lower limit one-sided 95% CI for the difference in AUCs (3DS minus 2D FFDM) is greater than -0.05. That is, our null hypothesis is that the AUC for 3D + s2D is 0.05 less than the AUC for 2D FFDM. A difference of 0.05 is considered a clinically significant difference.||||||0.009|||||||MRMC ROC Analysis|||A multi-reader, multi-case ROC analysis will be used to compare 3D + s2D to 2D FFDM. The areas under the curve (AUC) will be used to compare ROC performance.||||0.009
70929746|NCT00971087|141356963|NON_INFERIORITY|A multi-reader, multi-case ROC analysis will be used to compare 3DS to 2D FFDM. The areas under the curve (AUC) will be used to compare ROC performance. 3DS will be considered non-inferior to 2D FFDM if the lower limit onesided 95% CI for the difference in AUCs (3DS minus 2D FFDM) is greater than -0.05.||||||0.045|||||||MRMC ROC Analysis|||||||0.045
71014415|NCT03522506|141535531|SUPERIORITY|6 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.01||||0.984|TWO_SIDED|95.0|-0.86|0.85|||Linear mixed effect model|||||0.85|-0.86|0.984
71014416|NCT03522506|141535531|SUPERIORITY|6 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.29||||0.508|TWO_SIDED|95.0|-1.14|0.57|||Linear mixed effect model|||||0.57|-1.14|0.508
71014417|NCT03522506|141535531|SUPERIORITY|6 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.22||||0.605|TWO_SIDED|95.0|-1.06|0.62|||Linear mixed effect model|||||0.62|-1.06|0.605
71049026|NCT02944383|141606129|SUPERIORITY||Median Difference (Net)|2.02||||0.5382|TWO_SIDED|95.0|-6.77|9.71||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|VLDL||9.71|-6.77|0.5382
70929747|NCT04479761|141356965|OTHER|T test derived from a linear mixed effects model|Mean Difference (Final Values)|0.52||||0.005|TWO_SIDED|95.0|||||Mixed Models Analysis||we provided the mean difference between the vestibular group and healthy controls for the reported condition.|||||0.005
70929748|NCT04479761|141356966|OTHER|T tests derived from linear mixed effects model|Mean Difference (Final Values)|0.23||||0.008|TWO_SIDED||||||Mixed Models Analysis||we provided the mean difference between the vestibular group and the controls on the reported condition.|||||0.008
70929749|NCT04011644|141356977|SUPERIORITY|||||||0.688|||||||Mixed Models Analysis|Quanbeck,A.et al. A randomized trial testing digital medicine support models for mild-to-moderate alcohol use disorder. npj Digit. Med.7,248(2024)||||||0.688
70929750|NCT04011644|141356978|SUPERIORITY|||||||0.261|||||||Mixed Models Analysis|||||||0.261
70929751|NCT04011644|141356979|SUPERIORITY|||||||0.014|||||||Mixed Models Analysis|||||||0.014
70929752|NCT04011644|141356981|SUPERIORITY|||||||0.908|||||||ANCOVA|||A univariate analysis (Analysis of Covariance or ANCOVA) was conducted to compare the number of hospital days among the three groups controlling for baseline assessment of the dependent variable and design factors (i.e., Sex and Severity).||||0.908
71104390|NCT02757768|141715925|SUPERIORITY||LS Mean of Difference|0.13|STANDARD_ERROR_OF_MEAN|0.11||0.226|TWO_SIDED|95.0|-0.08|0.34|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.34|-0.08|0.226
71104391|NCT02757768|141715925|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.11||0.501|TWO_SIDED|95.0|-0.14|0.28|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.28|-0.14|0.501
71104392|NCT02757768|141715925|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.984|TWO_SIDED|95.0|-0.22|0.23|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.23|-0.22|0.984
71104393|NCT02757768|141715925|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.11||0.78|TWO_SIDED|95.0|-0.18|0.24|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.24|-0.18|0.780
71014418|NCT03522506|141535531|SUPERIORITY|2 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|0.11||||0.847|TWO_SIDED|95.0|-1.06|1.29|||Linear mixed effect model|||||1.29|-1.06|0.847
71014419|NCT03522506|141535531|SUPERIORITY|2 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.44||||0.455|TWO_SIDED|95.0|-1.61|0.73|||Linear mixed effect model|||||0.73|-1.61|0.455
71014420|NCT03522506|141535531|SUPERIORITY|2 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.58||||0.317|TWO_SIDED|95.0|-1.74|0.57|||Linear mixed effect model|||||0.57|-1.74|0.317
71014421|NCT03522506|141535531|SUPERIORITY|2.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-2.0||||0.001|TWO_SIDED|95.0|-3.18|-0.83|||Linear mixed effect model|||||-0.83|-3.18|0.001
71049027|NCT02944383|141606129|SUPERIORITY||Median Difference (Net)|0.0||||0.1727|TWO_SIDED|95.0|-0.51|1.01||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|LDL||1.01|-0.51|0.1727
71049028|NCT02944383|141606129|SUPERIORITY||Median Difference (Net)|0.0||||0.4567|TWO_SIDED|95.0|-0.51|0.51||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|LDL||0.51|-0.51|0.4567
71049029|NCT02944383|141606129|SUPERIORITY||Median Difference (Net)|0.0||||0.6142|TWO_SIDED|95.0|-1.21|1.47||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|HDL||1.47|-1.21|0.6142
71104394|NCT02757768|141715926|SUPERIORITY||LS Mean of Difference|3.1|STANDARD_ERROR_OF_MEAN|1.9||0.107|TWO_SIDED|95.0|-0.7|6.8|||ANCOVA|||Week 4 Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||6.8|-0.7|0.107
71104395|NCT02757768|141715926|SUPERIORITY||LS Mean of Difference|2.5|STANDARD_ERROR_OF_MEAN|1.9||0.19|TWO_SIDED|95.0|-1.3|6.3|||ANCOVA|||Week 8 Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||6.3|-1.3|0.190
71104396|NCT02757768|141715926|SUPERIORITY||LS Mean of Difference|2.2|STANDARD_ERROR_OF_MEAN|2.1||0.297|TWO_SIDED|95.0|-1.9|6.3|||ANCOVA|||Week 12 Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||6.3|-1.9|0.297
70850578|NCT02712047|141189436|OTHER||Ratio|0.79|||||TWO_SIDED|95.0|0.66|0.93|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 14, AM|||0.93|0.66|
70850579|NCT02712047|141189436|OTHER||Ratio|0.67|||||TWO_SIDED|95.0|0.56|0.79|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 14, PM|||0.79|0.56|
70929753|NCT04011644|141356983|SUPERIORITY|||||||0.206|||||||ANCOVA|||A univariate analysis (Analysis of Covariance or ANCOVA) was conducted to compare the number of hospital days among the three groups controlling for baseline assessment of the dependent variable and design factors (i.e., Sex and Severity).||||0.206
70929754|NCT04011644|141356984|SUPERIORITY|||||||0.104|||||||ANCOVA|||A univariate analysis (Analysis of Covariance or ANCOVA) was conducted to compare the number of hospital days among the three groups controlling for baseline assessment of the dependent variable and design factors (i.e., Sex and Severity).||||0.104
70929755|NCT04011644|141356985|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71014422|NCT03522506|141535531|SUPERIORITY|2.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-3.61|||<|0.001|TWO_SIDED|95.0|-4.79|-2.44|||Linear mixed effect model|||||-2.44|-4.79|<0.001
71014423|NCT03522506|141535531|SUPERIORITY|2.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-3.16|||<|0.001|TWO_SIDED|95.0|-4.32|-2.01|||Linear mixed effect model|||||-2.01|-4.32|<0.001
71014424|NCT03522506|141535531|SUPERIORITY|4.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-1.69||||0.003|TWO_SIDED|95.0|-2.78|-0.6|||Linear mixed effect model|||||-0.60|-2.78|0.003
71014425|NCT03522506|141535531|SUPERIORITY|4.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-4.3|||<|0.001|TWO_SIDED|95.0|-5.39|-3.21|||Linear mixed effect model|||||-3.21|-5.39|<0.001
71014426|NCT03522506|141535531|SUPERIORITY|4.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-3.83|||<|0.001|TWO_SIDED|95.0|-4.91|-2.76|||Linear mixed effect model|||||-2.76|-4.91|<0.001
71014427|NCT03522506|141535531|SUPERIORITY|6.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.71||||0.13|TWO_SIDED|95.0|-1.63|0.21|||Linear mixed effect model|||||0.21|-1.63|0.130
71014428|NCT03522506|141535531|SUPERIORITY|6.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-3.32|||<|0.001|TWO_SIDED|95.0|-4.24|-2.4|||Linear mixed effect model|||||-2.40|-4.24|<0.001
71049030|NCT02944383|141606129|SUPERIORITY||Median Difference (Net)|-0.02||||0.2409|TWO_SIDED|95.0|-2.23|1.29||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|HDL||1.29|-2.23|0.2409
71049031|NCT02944383|141606130|SUPERIORITY|||||||0.2721||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||VLDL||||0.2721
71049032|NCT02944383|141606130|SUPERIORITY|||||||0.5669||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||VLDL||||0.5669
71049033|NCT02944383|141606130|SUPERIORITY|||||||0.1686||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||LDL||||0.1686
70929756|NCT04011644|141356986|SUPERIORITY|||||||0.025|||||||Mixed Models Analysis|||||||0.025
70929757|NCT04011644|141356987|SUPERIORITY|||||||0.555|||||||Mixed Models Analysis|||||||0.555
70929758|NCT04011644|141356988|SUPERIORITY|||||||0.131|||||||Kruskal-Wallis|||||||0.131
70929759|NCT04011644|141356992|SUPERIORITY|||||||0.02|||||||Kruskal-Wallis|||||||0.02
70929760|NCT05265065|141356994|NON_INFERIORITY|"Non-inferiority margin of -10% (absolute difference) and a one-sided significance level of 5%.~The sample size calculation assumed an estimated seroresponse rate of 95% in both half- and full-dose arms, a non- inferiority margin of -10% (absolute difference), a one-sided significance level of5%, and no loss to follow- up. Under this scenario, a sample size of 100 per arm provides 90% power to compare seroresponse rates between arms under the non-inferiority framework."|Risk Difference (RD)|-2.9|||||TWO_SIDED|95.0|-7.7|2.0|||Regression, Logistic||The difference in seroresponse was adjusted for age group, priming vaccine, duration between first and second dose, duration between second and third (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|Non-inferiority margin of -10% (absolute difference) and a one-sided significance level of 5%.||2.0|-7.7|
70929761|NCT05265065|141356996|NON_INFERIORITY|Non-inferiority margin of -10% (absolute difference)|Risk Difference (RD)|-2.4|||||TWO_SIDED|95.0|-16.1|11.3|||Regression, Logistic||The difference in seroresponse was adjusted for age group, priming vaccine, duration between first and second dose, duration between second and third (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||11.3|-16.1|
71014429|NCT03522506|141535531|SUPERIORITY|6.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-2.71|||<|0.001|TWO_SIDED|95.0|-3.62|-1.8|||Linear mixed effect model|||||-1.80|-3.62|<0.001
71014430|NCT03522506|141535531|SUPERIORITY|8.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.26||||0.577|TWO_SIDED|95.0|-1.2|0.68|||Linear mixed effect model|||||0.68|-1.20|0.577
71014431|NCT03522506|141535531|SUPERIORITY|8.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-2.26|||<|0.001|TWO_SIDED|95.0|-3.2|-1.32|||Linear mixed effect model|||||-1.32|-3.20|<0.001
71014432|NCT03522506|141535531|SUPERIORITY|8.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-1.65|||<|0.001|TWO_SIDED|95.0|-2.57|-0.72|||Linear mixed effect model|||||-0.72|-2.57|<0.001
71014433|NCT03522506|141535531|SUPERIORITY|1.75 hours post-infusion end: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|0.31||||0.475|TWO_SIDED|95.0|-0.55|1.16|||Linear mixed effect model|||||1.16|-0.55|0.475
70850580|NCT02712047|141189436|OTHER||Ratio|0.79|||||TWO_SIDED|95.0|0.66|0.93|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 15, AM|||0.93|0.66|
71049034|NCT02944383|141606130|SUPERIORITY|||||||0.4308||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||LDL||||0.4308
71049035|NCT02944383|141606130|SUPERIORITY|||||||0.5495||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||HDL||||0.5495
71049036|NCT02944383|141606130|SUPERIORITY|||||||0.2384||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||HDL||||0.2384
71049037|NCT02944383|141606131|SUPERIORITY||Median Difference (Net)|-13.99||||0.0781|TWO_SIDED|95.0|-33.76|2.55||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|VLDL \& Chylomicron particles||2.55|-33.76|0.0781
71049038|NCT02944383|141606131|SUPERIORITY||Median Difference (Net)|-2.1||||0.9901|TWO_SIDED|95.0|-19.36|19.01||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|VLDL \& Chylomicron particles||19.01|-19.36|0.9901
71049039|NCT02944383|141606131|SUPERIORITY||Median Difference (Net)|-25.23||||0.0717|TWO_SIDED|95.0|-43.62|-5.1||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|LDL Particles||-5.10|-43.62|0.0717
70850581|NCT02712047|141189436|OTHER||Ratio|0.79|||||TWO_SIDED|95.0|0.66|0.94|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 15, PM|||0.94|0.66|
71049040|NCT02944383|141606131|SUPERIORITY||Median Difference (Net)|-16.09||||0.1548|TWO_SIDED|95.0|-36.78|3.76||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|LDL Particles||3.76|-36.78|0.1548
71049041|NCT02944383|141606131|SUPERIORITY||Median Difference (Net)|-47.16||||0.0428|TWO_SIDED|95.0|-119.58|-5.78||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|IDL Particles||-5.78|-119.58|0.0428
71049042|NCT02944383|141606131|SUPERIORITY||Median Difference (Net)|-26.13||||0.1836|TWO_SIDED|95.0|-121.44|19.48||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|IDL Particles||19.48|-121.44|0.1836
71104397|NCT02757768|141715926|SUPERIORITY||LS Mean of Difference|1.4|STANDARD_ERROR_OF_MEAN|2.1||0.493|TWO_SIDED|95.0|-2.7|5.5|||ANCOVA|||EoT Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||5.5|-2.7|0.493
71014434|NCT03522506|141535531|SUPERIORITY|1.75 hours post-infusion end: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.14||||0.753|TWO_SIDED|95.0|-0.99|0.72|||Linear mixed effect model|||||0.72|-0.99|0.753
71014435|NCT03522506|141535531|SUPERIORITY|1.75 hours post-infusion end: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.99||||0.022|TWO_SIDED|95.0|-1.83|-0.15|||Linear mixed effect model|||||-0.15|-1.83|0.022
71014436|NCT03522506|141535532|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|22.94|||<|0.001|TWO_SIDED|95.0|16.58|29.3|||Linear mixed effect model|||||29.30|16.58|<0.001
71014437|NCT03522506|141535532|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|30.95|||<|0.001|TWO_SIDED|95.0|24.59|37.31|||Linear mixed effects model|||||37.31|24.59|<0.001
71014438|NCT03522506|141535532|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|26.5|||<|0.001|TWO_SIDED|95.0|20.24|32.75|||Linear mixed effect model|||||32.75|20.24|<0.001
71014439|NCT03522506|141535533|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|14.56|||<|0.001|TWO_SIDED|95.0|7.04|22.08|||Linear mixed effect model|||||22.08|7.04|<0.001
71014440|NCT03522506|141535533|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|32.21|||<|0.001|TWO_SIDED|95.0|24.68|39.73|||Linear mixed effect model|||||39.73|24.68|<0.001
71014441|NCT03522506|141535533|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|25.74|||<|0.001|TWO_SIDED|95.0|18.33|33.14|||Linear mixed effect model|||||33.14|18.33|<0.001
71014442|NCT03522506|141535534|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|9.6||||0.003|TWO_SIDED|95.0|3.35|15.85|||Linear mixed effect model|||||15.85|3.35|0.003
71014443|NCT03522506|141535534|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|33.33|||<|0.001|TWO_SIDED|95.0|27.08|39.58|||Linear mixed effect model|||||39.58|27.08|<0.001
71049043|NCT02944383|141606132|SUPERIORITY|||||||0.1251||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||VLDL \& Chylomicron Particles||||0.1251
71049044|NCT02944383|141606132|SUPERIORITY|||||||0.9047||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||VLDL \& Chylomicron Particles||||0.9047
71104398|NCT02445911|141715942|OTHER||Least-squares Mean Difference|-6.78|||||TWO_SIDED|95.0|-23.75|10.18|||||Least-squares means have baseline and site as covariates. Placebo was the reference group.|||10.18|-23.75|
71104399|NCT02445911|141715942|OTHER||Least-squares Mean Difference|-2.97|||||TWO_SIDED|95.0|-19.65|13.72|||||Least-squares means have baseline and site as covariates. Placebo was the reference group.|||13.72|-19.65|
71104400|NCT02445911|141715942|OTHER||Least-squares Mean Difference|-5.05|||||TWO_SIDED|95.0|-21.97|11.88|||||Least-squares means have baseline and site as covariates. Placebo was the reference group.|||11.88|-21.97|
71104401|NCT01649869|141715960|SUPERIORITY|||||||0.0859|||||||Generalized linear model|Generalized linear model for binary outcome based on generalized estimating equations.||||||0.0859
71104402|NCT01649869|141715961|SUPERIORITY|||||||0.7068|||||||Fisher Exact|||||||0.7068
71104403|NCT01649869|141715962|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
71104404|NCT01649869|141715963|SUPERIORITY|||||||0.7068|||||||Fisher Exact|||||||0.7068
71104405|NCT01649869|141715964|SUPERIORITY|||||||0.0752|||||||Fisher Exact|||||||0.0752
71014444|NCT03522506|141535534|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|16.91|||<|0.001|TWO_SIDED|95.0|10.77|23.06|||Linear mixed effect model|||||23.06|10.77|<0.001
71014445|NCT03522506|141535535|SUPERIORITY|An analysis of variance (ANOVA) model was used to evaluate the 1 hour post the end of infusion MWT. The LSM sleep latency for each treatment and the associated standard error and 95% CI were estimated from the model, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-2.16||||0.436|TWO_SIDED|95.0|-7.68|3.36|||ANOVA|||||3.36|-7.68|0.436
71014446|NCT03522506|141535535|SUPERIORITY|ANOVA model was used to evaluate the 1 hour post the end of infusion MWT. The LSM sleep latency for each treatment and the associated standard error and 95% CI were estimated from the model, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-2.29||||0.409|TWO_SIDED|95.0|-7.81|3.23|||ANOVA|||||3.23|-7.81|0.409
71014447|NCT03522506|141535535|SUPERIORITY|ANOVA model was used to evaluate the 1 hour post the end of infusion MWT. The LSM sleep latency for each treatment and the associated standard error and 95% CI were estimated from the model, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|16.77|||<|0.001|TWO_SIDED|95.0|11.37|22.18|||ANOVA|||||22.18|11.37|<0.001
71049045|NCT02944383|141606132|SUPERIORITY|||||||0.0788||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||LDL Particles||||0.0788
71104406|NCT01649869|141715966|SUPERIORITY|||||||0.4823|||||||Generalized linear model|Generalized linear model for binary outcome using generalized estimating equations.||||||0.4823
71104407|NCT01649869|141715967|SUPERIORITY|||||||0.0859|||||||Generalized linear model|Generalized linear model for binary outcome using generalized estimating equations.||||||0.0859
71104408|NCT01649869|141715968|OTHER|Association of binary outcome and continuous outcome||||||0.8212|||||||Generalized linear model|For binary outcome using generalized estimating equations||||||0.8212
71014448|NCT03480243|141535536|OTHER||Cmax Estimate Ratio|1.9|||||TWO_SIDED|90.0|1.59|2.27|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||2.27|1.59|
71014449|NCT03480243|141535536|OTHER||Cmax Estimate Ratio|1.81|||||TWO_SIDED|90.0|1.51|2.16|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||2.16|1.51|
71014450|NCT03480243|141535537|OTHER||AUC Estimate Ratio|1.8|||||TWO_SIDED|90.0|1.5|2.17|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||2.17|1.50|
71014451|NCT03480243|141535537|OTHER||AUC Estimate Ratio|1.64|||||TWO_SIDED|90.0|1.36|1.97|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||1.97|1.36|
71014452|NCT03480243|141535538|OTHER||Cmax,ss Estimate Ratio|2.13|||||TWO_SIDED|90.0|1.77|2.55|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||2.55|1.77|
71014453|NCT03480243|141535538|OTHER||Cmax,ss Estimate Ratio|2.13|||||TWO_SIDED|90.0|1.78|2.56|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||2.56|1.78|
71014454|NCT03480243|141535539|OTHER||AUCtau Estimate Ratio|2.48|||||TWO_SIDED|90.0|2.02|3.03|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||3.03|2.02|
71014455|NCT03480243|141535539|OTHER||AUCtau Estimate Ratio|2.23|||||TWO_SIDED|90.0|1.82|2.73|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||2.73|1.82|
71014456|NCT01522755|141535566|OTHER|t-test|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71014457|NCT01522755|141535567|OTHER|t-test|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71014458|NCT01522755|141535568|OTHER|t-test|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71014459|NCT02388906|141535569|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0003|TWO_SIDED|95.0|0.6|0.86|||Log Rank|Stratified log rank||||0.86|0.60|0.0003
71014460|NCT02388906|141535570|SUPERIORITY||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.03|0.69|1.11|||Log Rank||Stratified Cox proportional hazard model|||1.11|0.69|
71014461|NCT02388906|141535577|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.63|0.9|||Log Rank|Stratified log rank||||0.90|0.63|
71014462|NCT04365387|141535579|OTHER||Cochran-Mantel-Haenszel|2.1|||||TWO_SIDED|90.0|-10.3|14.5|||||Risk Difference (90% CI) were estimated using weighted average of stratum-specific proportion using Cochran-Mantel-Haenszel (CMH).|||14.5|-10.3|
71049046|NCT02944383|141606132|SUPERIORITY|||||||0.1222||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||LDL Particles||||0.1222
71104409|NCT01649869|141715969|OTHER|Association of binary outcome and continuous outcome and continuous outcome||||||0.8356|||||||Generalized linear model|Generalized linear model for binary outcome using generalized estimating equations.||||||0.8356
71104410|NCT01649869|141715970|OTHER|Association of binary outcome and continuous outcome||||||0.7961|||||||Generalized linear model|Generalized linear model for binary outcome using generalized estimating equations||||||0.7961
71104411|NCT01649869|141715971|OTHER|Association of binary outcome and continuous outcome||||||0.8675|||||||Generalized linear model|Generalized linear model for binary outcome||||||0.8675
71049047|NCT02944383|141606132|SUPERIORITY|||||||0.0734||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||IDL Particles||||0.0734
71049048|NCT02944383|141606132|SUPERIORITY|||||||0.421||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||IDL Particles||||0.4210
71049049|NCT02944383|141606133|SUPERIORITY||Median Difference (Net)|0.43||||0.9672|TWO_SIDED|95.0|-8.12|9.07||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|||9.07|-8.12|0.9672
71049050|NCT02944383|141606133|SUPERIORITY||Median Difference (Net)|1.58||||0.7993|TWO_SIDED|95.0|-5.31|8.69||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|||8.69|-5.31|0.7993
71049051|NCT02944383|141606134|SUPERIORITY|||||||0.8602||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||||||0.8602
71049052|NCT02944383|141606134|SUPERIORITY|||||||0.8555||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||||||0.8555
71049053|NCT02944383|141606135|SUPERIORITY|||||||0.0583||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0583
71049054|NCT02944383|141606135|SUPERIORITY|||||||0.2289||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.2289
70850582|NCT02712047|141189436|OTHER||Ratio|0.74|||||TWO_SIDED|95.0|0.62|0.87|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 16, AM|||0.87|0.62|
71049055|NCT02944383|141606135|SUPERIORITY|||||||0.0416||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0416
71049056|NCT02944383|141606135|SUPERIORITY|||||||0.015||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0150
71049057|NCT02944383|141606135|SUPERIORITY||Median Difference (Net)|-26.21||||0.0718|TWO_SIDED|95.0|-54.29|-1.26||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-1.26|-54.29|0.0718
71049058|NCT02944383|141606135|SUPERIORITY||Median Difference (Net)|-18.68||||0.1248|TWO_SIDED|95.0|-50.0|7.31||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||7.31|-50.00|0.1248
71049059|NCT02944383|141606136|SUPERIORITY|||||||0.2397||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.2397
71049060|NCT02944383|141606136|SUPERIORITY|||||||0.5399||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.5399
71049061|NCT02944383|141606136|SUPERIORITY|||||||0.0409||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0409
71104412|NCT01649869|141715972|OTHER|Association of binary outcome and continuous outcome||||||0.9682|||||||Generalized linear model|Generalized linear model for binary outcome||||||0.9682
71104413|NCT01649869|141715973|OTHER|Association of binary outcome and continuous outcome||||||0.6063|||||||Generalized linear model|Generalized linear model for binary outcome||||||0.6063
71104414|NCT01649869|141715974|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||||||0.0001
71104415|NCT01649869|141715975|SUPERIORITY|||||||0.6043|||||||Fisher Exact|||||||0.6043
71104416|NCT01649869|141715976|SUPERIORITY|||||||0.6513|||||||Fisher Exact|||||||0.6513
71104417|NCT01649869|141715977|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71104418|NCT01649869|141715978|SUPERIORITY|||||||0.0659|||||||Fisher Exact|||||||0.0659
71104419|NCT01649869|141715979|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71104420|NCT05395338|141716019|OTHER|cox proportional hazards models with stratification by matching pairs|Hazard Ratio (HR)|0.9||||0.183|TWO_SIDED|95.0|0.78|1.05|||Regression, Cox||rt-PA/non reperfusion|||1.05|0.78|0.183
71104421|NCT05395338|141716020|OTHER|Conditional logistic regression models with stratification by matching pairs.|Odds Ratio (OR)|1.25|||<|0.001|TWO_SIDED|95.0|1.12|1.39|||Regression, Logistic|||||1.39|1.12|<0.001
71104422|NCT05395338|141716021|OTHER|Conditional logistic regression models with stratification by matching pairs.|Odds Ratio (OR)|1.23|||<|0.001|TWO_SIDED|95.0|1.11|1.36|||Regression, Logistic||rt-PA/non reperfusion|||1.36|1.11|<0.001
71049062|NCT02944383|141606136|SUPERIORITY|||||||0.0073||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0073
71049063|NCT02944383|141606136|SUPERIORITY|||||||0.0976||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0976
70850583|NCT02712047|141189436|OTHER||Ratio|0.73|||||TWO_SIDED|95.0|0.61|0.86|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 16, PM|||0.86|0.61|
70850584|NCT02712047|141189436|OTHER||Ratio|0.77|||||TWO_SIDED|95.0|0.65|0.91|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 17, AM|||0.91|0.65|
70850585|NCT02712047|141189436|OTHER||Ratio|0.81|||||TWO_SIDED|95.0|0.65|1.01|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 17, PM|||1.01|0.65|
70850586|NCT02712047|141189436|OTHER||Ratio|0.77|||||TWO_SIDED|95.0|0.61|0.96|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 18, AM|||0.96|0.61|
70850587|NCT02712047|141189436|OTHER||Ratio|0.77|||||TWO_SIDED|95.0|0.59|1.0|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 18, PM|||1.00|0.59|
70850588|NCT02712047|141189436|OTHER||Ratio|0.81|||||TWO_SIDED|95.0|0.63|1.05|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 19, AM|||1.05|0.63|
70850589|NCT02712047|141189436|OTHER||Ratio|0.72|||||TWO_SIDED|95.0|0.52|1.0|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 19, PM|||1.00|0.52|
70850590|NCT02712047|141189436|OTHER||Ratio|0.78|||||TWO_SIDED|95.0|0.56|1.09|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 20, AM|||1.09|0.56|
70850591|NCT02712047|141189436|OTHER||Ratio|0.78|||||TWO_SIDED|95.0|0.53|1.14|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 20, PM|||1.14|0.53|
70850592|NCT02712047|141189436|OTHER||Ratio|0.85|||||TWO_SIDED|95.0|0.59|1.22|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 21, AM|||1.22|0.59|
70929762|NCT05265065|141356996|NON_INFERIORITY|Non-inferiority margin of -10% (absolute difference)|Risk Difference (RD)|-3.1|||||TWO_SIDED|95.0|-9.5|3.2|||Regression, Logistic||The difference in seroresponse was adjusted for age group, priming vaccine, duration between first and second dose, duration between second and third (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||3.2|-9.5|
70929763|NCT05265065|141356996|NON_INFERIORITY|Non-inferiority margin of -10% (absolute difference)|Risk Difference (RD)|-0.5|||||TWO_SIDED|95.0|-17.1|16.1|||Regression, Logistic||The difference in seroresponse was adjusted for age group, priming vaccine, duration between first and second dose, duration between second and third (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||16.1|-17.1|
70929764|NCT05265065|141356997|SUPERIORITY||Geometric Mean Ratio|0.94||||0.228|TWO_SIDED|95.0|0.86|1.04|||Regression, Linear||Adjusted for age group, priming vaccine, duration between 1st and 2nd dose, duration between 2nd and 3rd (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||1.04|0.86|0.228
70929765|NCT05265065|141356998|SUPERIORITY||Geometric Mean Ratio|0.94||||0.537|TWO_SIDED|95.0|0.77|1.15|||Regression, Linear||Adjusted for age group, priming vaccine, duration between 1st and 2nd dose, duration between 2nd and 3rd (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||1.15|0.77|0.537
70929766|NCT05265065|141356998|SUPERIORITY||Geometric Mean Ratio|0.99||||0.922|TWO_SIDED|95.0|0.89|1.11|||Regression, Linear||Adjusted for age group, priming vaccine, duration between 1st and 2nd dose, duration between 2nd and 3rd (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||1.11|0.89|0.922
70929767|NCT05265065|141356998|SUPERIORITY||Geometric Mean Ratio|0.71||||0.014|TWO_SIDED|95.0|0.54|0.93|||Regression, Linear||Adjusted for age group, priming vaccine, duration between 1st and 2nd dose, duration between 2nd and 3rd (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||0.93|0.54|0.014
70929768|NCT04181736|141357030|OTHER||F-statistic|6.621||||0.02|TWO_SIDED|||||The a priori threshold for statistical significance was \<0.05.|Repeated Measures General Linear Model|||Test of the effect of guanfacine using a general linear model including a within subjects' effect for treatment (pre- versus post-treatment sessions) and for circuit function, with five repeated measures for each circuit measure defining the cognitive control circuit.||||0.020
70929769|NCT04181736|141357035|OTHER||Cohen's d effect size|1.47|||<|0.001|TWO_SIDED|95.0|0.937|2.002||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||A paired t-test was conducted to evaluate the effect of GIR on changes in HDRS-17 depression scores from pre-treatment to week 2.||2.002|0.937|<0.001
71049064|NCT02944383|141606136|SUPERIORITY|||||||0.1899||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.1899
71049065|NCT02944383|141606137|SUPERIORITY|||||||0.1747||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1747
70929770|NCT04181736|141357035|OTHER||Cohen's d effect size|3.152|||<|0.001|TWO_SIDED|95.0|2.757|3.547||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||A paired t-test was conducted to evaluate the effect of GIR on changes in HDRS-17 depression scores from pre-treatment to post-treatment sessions.||3.547|2.757|<0.001
70929771|NCT04181736|141357036|OTHER||Cohen's d effect size|-1.249|||<|0.001|TWO_SIDED|95.0|-1.724|-0.774||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||A paired t-test was conducted to evaluate the effect of GIR on changes in QIDS-SR depression scores from pre-treatment to post-treatment sessions.||-0.774|-1.724|< 0.001
70929772|NCT04181736|141357037|OTHER||F-statistic|19.362|||<|0.001|TWO_SIDED|||||The a priori threshold for statistical significance was \<0.05.|Repeated Measures General Linear Model|||Test of the effect of guanfacine using a general linear model including a within subjects' effect for treatment (pre- versus post-treatment sessions) and for cognitive control function, with six repeated measures for behavioral tests of cognitive control.||||<0.001
70929773|NCT04181736|141357038|OTHER||Cohen's d effect size|0.881||||0.002|TWO_SIDED|95.0|0.324|1.438||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||A paired t-test was conducted to evaluate the effect of GIR on changes in SWLS scores from pre-treatment to post-treatment sessions.||1.438|0.324|0.002
70929774|NCT04181736|141357039|OTHER||F-statistic|11.913||||0.003|TWO_SIDED|||||The a priori threshold for statistical significance was \<0.05.|Repeated Measures General Linear Model|||Test of the effect of guanfacine using a general linear model including a within subjects' effect for treatment (pre- versus post-treatment sessions) and for quality with four repeated measures for domains of quality of life.||||0.003
70929775|NCT04181736|141357040|OTHER||Cohen's d effect size|-0.2||||0.283|TWO_SIDED|95.0|-0.608|0.208||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||A paired t-test was conducted to evaluate the effect of GIR on changes in C-SSRS scores from pre-treatment to post-treatment sessions.||0.208|-0.608|0.283
70929776|NCT02865538|141357098|OTHER|Descriptive Analysis|LS means difference|0.09|STANDARD_ERROR_OF_MEAN|0.127||0.4641|TWO_SIDED|90.0|-0.12|0.3|||Linear mixed-effects model||Change from Week -1 to Week 1|||0.30|-0.12|0.4641
70929777|NCT02865538|141357098|OTHER|Descriptive Analysis|Linear mixed-effects model|0.0|STANDARD_ERROR_OF_MEAN|0.128||0.9894|TWO_SIDED|90.0|-0.21|0.21|||LS means difference||Change from Week -1 to Week 1|||0.21|-0.21|0.9894
71049066|NCT02944383|141606137|SUPERIORITY|||||||0.4576||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.4576
71049067|NCT02944383|141606137|SUPERIORITY|||||||0.1549||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1549
70929778|NCT02865538|141357098|OTHER|Descriptive Analysis|LS means difference|-0.31|STANDARD_ERROR_OF_MEAN|0.129||0.0199|TWO_SIDED|90.0|-0.52|-0.09|||Linear mixed-effects model||Change from Week -1 to Week 1|||-0.09|-0.52|0.0199
71104423|NCT05395338|141716022|OTHER|Conditional logistic regression models with stratification by matching pairs|Odds Ratio (OR)|0.73|||<|0.001|TWO_SIDED|95.0|0.64|0.83|||Regression, Logistic||rt-PA/non reperfusion|||0.83|0.64|<0.001
70929779|NCT02865538|141357098|OTHER|Descriptive Analysis|LS means difference|-0.12|STANDARD_ERROR_OF_MEAN|0.133||0.3907|TWO_SIDED|90.0|-0.34|0.11|||Linear mixed-effects model||Change from Week -1 to Week 1|||0.11|-0.34|0.3907
70929780|NCT02865538|141357098|OTHER|Descriptive Analysis|LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.166||0.5393|TWO_SIDED|90.0|-0.17|0.38|||Linear mixed-effects model||Change from Week -1 to Week 2|||0.38|-0.17|0.5393
70929781|NCT02865538|141357098|OTHER|Descriptive Analysis|LS means difference|-0.04|STANDARD_ERROR_OF_MEAN|0.169||0.7931|TWO_SIDED|90.0|-0.33|0.24|||Linear mixed-effects model||Change from Week -1 to Week 2|||0.24|-0.33|0.7931
70929782|NCT02865538|141357098|OTHER|Descriptive Analysis|LS means difference|-0.63|STANDARD_ERROR_OF_MEAN|0.169||0.0004|TWO_SIDED|90.0|-0.92|-0.35|||Linear mixed-effects model||Change from Week -1 to Week 2|||-0.35|-0.92|0.0004
70929783|NCT02865538|141357098|OTHER|Descriptive Analysis|LS means difference|-0.16|STANDARD_ERROR_OF_MEAN|0.175||0.3739|TWO_SIDED|90.0|-0.45|0.13|||Linear mixed-effects model||Change from Week -1 to Week 2|||0.13|-0.45|0.3739
70929784|NCT02865538|141357099|OTHER|Descriptive Analysis|LS means difference|5.29|STANDARD_ERROR_OF_MEAN|3.077||0.09|TWO_SIDED|90.0|0.16|10.42|||Linear mixed-effects model||Change from Week -1 to Week 1|||10.42|0.16|0.0900
70929785|NCT02865538|141357099|OTHER|Descriptive Analysis|LS means difference|-4.46|STANDARD_ERROR_OF_MEAN|3.053||0.1487|TWO_SIDED|90.0|-9.55|0.63|||Linear mixed-effects model||Change from Week -1 to Week 1|||0.63|-9.55|0.1487
70929786|NCT02865538|141357099|OTHER|Descriptive Analysis|LS means difference|-10.18|STANDARD_ERROR_OF_MEAN|3.015||0.0012|TWO_SIDED|90.0|-15.2|-5.15|||Linear mixed-effects model||Change from Week -1 to Week 1|||-5.15|-15.20|0.0012
70929787|NCT02865538|141357099|OTHER|Descriptive Analysis|LS means difference|-6.14|STANDARD_ERROR_OF_MEAN|3.142||0.0548|TWO_SIDED|90.0|-11.37|-0.9|||Linear mixed-effects model||Change from Week -1 to Week 1|||-0.90|-11.37|0.0548
70929788|NCT02865538|141357099|OTHER|Descriptive Analysis|LS means difference|6.59|STANDARD_ERROR_OF_MEAN|3.337||0.0522|TWO_SIDED|90.0|1.03|12.15|||Linear mixed-effects model||Change from Week -1 to Week 2|||12.15|1.03|0.0522
71014463|NCT04365387|141535580|OTHER||Cochran-Mantel-Haenszel|-4.6|||||TWO_SIDED|90.0|-14.9|5.7|||||Risk Difference (90% CI) were estimated using weighted average of stratum-specific proportion using CMH.|||5.7|-14.9|
71014464|NCT04365387|141535582|OTHER||Cochran-Mantel-Haenszel|1.4|||||TWO_SIDED|90.0|-3.2|5.9|||||Risk Difference (90% CI) were estimated using weighted average of stratum-specific proportion using CMH.|||5.9|-3.2|
71014465|NCT04365387|141535583|OTHER||Cochran-Mantel-Haenszel|13.3|||||TWO_SIDED|90.0|0.1|26.4|||||Risk Difference (90% CI) were estimated using weighted average of stratum-specific proportion using CMH for non-Imputed values|||26.4|0.1|
71014466|NCT04365387|141535584|OTHER||Cochran-Mantel-Haenszel|1.3|||||TWO_SIDED|90.0|-9.3|11.9|||||Risk Difference (90% CI) were estimated using weighted average of stratum-specific proportion using CMH.|||11.9|-9.3|
71014467|NCT04410991|141535585|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Relative risk|0.996||||0.9758|TWO_SIDED|95.0|0.754|1.315||Threshold for significance at 2-sided 0.05 level.|Chi-squared|||Analysis was performed using negative binomial model with number of adjudicated relapses onset between randomization date and EOS date as the response variable, treatment group, Gadolinium (Gd)-enhancing T1 lesions at baseline (presence, absence), expanded disability status scale (EDSS) strata (\<4, \>=4) and geographic region (United States \[US\], non-US) as covariates, and log transformed observation duration as the offset variable.||1.315|0.754|0.9758
71014468|NCT04410991|141535586|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Hazard Ratio (HR)|0.582||||0.0114|TWO_SIDED|95.0|0.38|0.891||Derived from log-rank test with stratification of EDSS strata (\<4, \>=4), geographic region (US, non-US).|Log Rank|||Analysis was performed using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4), geographic region (US, non-US).||0.891|0.380|0.0114
71014469|NCT04410991|141535587|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Hazard Ratio (HR)|0.641||||0.0181|TWO_SIDED|95.0|0.444|0.925||Derived from log-rank test with stratification of EDSS strata (\<4, \>=4), geographic region (US, non-US).|Log Rank|||Analysis was performed using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4), geographic region (US, non-US).||0.925|0.444|0.0181
71014470|NCT04410991|141535588|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Relative risk|1.165||||0.2362|TWO_SIDED|95.0|0.905|1.502|||Chi-squared|||Analysis was performed using negative binomial model with the number of new and/or enlarging T2-hyperintense lesions between randomization date and EOS date as the response variable, treatment group, baseline T2-hyperintense lesion count, EDSS strata (\<4, \>=4) and geographic region (US, non-US) as covariates, and log transformed observation duration as the offset variable.||1.502|0.905|0.2362
70929789|NCT02865538|141357099|OTHER|Descriptive Analysis|LS means difference|-5.07|STANDARD_ERROR_OF_MEAN|3.329||0.1326|TWO_SIDED|90.0|-10.61|0.48|||Linear mixed-effects model||Change from Week -1 to Week 2|||0.48|-10.61|0.1326
71049068|NCT02944383|141606137|SUPERIORITY|||||||0.2427||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2427
71104424|NCT05395338|141716023|OTHER|Ordinal logistic regression models|Odds Ratio (OR)|0.85|||<|0.001|TWO_SIDED|95.0|0.77|0.93|||Regression, Logistic||rt-PA/non reperfusion|||0.93|0.77|<0.001
70850593|NCT02712047|141189436|OTHER||Ratio|0.75|||||TWO_SIDED|95.0|0.5|1.13|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 21, PM|||1.13|0.50|
70929790|NCT02865538|141357099|OTHER|Descriptive Analysis|LS means difference|-12.28|STANDARD_ERROR_OF_MEAN|3.27||0.0004|TWO_SIDED|90.0|-17.73|-6.83|||Linear mixed-effects model||Change from Week -1 to Week 2|||-6.83|-17.73|0.0004
70929791|NCT02865538|141357099|OTHER|Descriptive Analysis|LS means difference|-7.79|STANDARD_ERROR_OF_MEAN|3.408||0.0253|TWO_SIDED|90.0|-13.47|-2.11|||Linear mixed-effects model||Change from Week -1 to Week 2|||-2.11|-13.47|0.0253
71014471|NCT04410991|141535589|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Relative risk|2.118|||<|0.0001|TWO_SIDED|95.0|1.502|2.987|||Chi-squared|||Analysis was performed using negative binomial model with the number of new Gd-enhancing T1-hyperintense lesions between randomization date and EOS date as the response variable, treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4) and geographic region (US, non-US) as covariates, and log transformed number of MRI scans as the offset variable.||2.987|1.502|<0.0001
71014472|NCT04410991|141535590|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Least square (LS) mean difference|-0.053||||0.31|TWO_SIDED|95.0|-0.156|0.05|||MMRM|||Covariates in the mixed-effect model with repeated measures (MMRM) were treatment group, EDSS strata (\<4, \>=4), geographic region (US, non-US), visit, treatment by visit interaction, baseline value, and baseline value-by-visit interaction.||0.050|-0.156|0.3100
71014473|NCT04410991|141535591|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS mean difference|-0.612||||0.5235|TWO_SIDED|95.0|-2.493|1.269|||MMRM|||Covariates in the MMRM were treatment group, EDSS strata (\<4, \>=4), geographic region (US, non-US), visit, treatment by visit interaction, baseline value, and baseline value-by-visit interaction.||1.269|-2.493|0.5235
71014474|NCT04410991|141535592|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Hazard Ratio (HR)|1.652||||0.0079|TWO_SIDED|95.0|1.145|2.383||Derived from log-rank test with stratification of EDSS strata (\<4, \>=4), geographic region (US, non-US).|Log Rank|||Analysis was performed using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4), geographic region (US, non-US).||2.383|1.145|0.0079
71014475|NCT04410991|141535593|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS mean difference|0.044||||0.4266|TWO_SIDED|95.0|-0.065|0.153|||MMRM|||Covariates in the MMRM were treatment group, EDSS strata (\<4, \>=4), geographic region (US, non-US), visit, treatment by visit interaction, cube root transformed Month 6 brain volume, and cube root transformed Month 6 brain volume-by-visit interaction.||0.153|-0.065|0.4266
71014476|NCT05966129|141535650|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.7957|TWO_SIDED|95.0|-18.3|23.8|||t-test, 2 sided||||Confidence Interval Width = 42.1|23.8|-18.3|0.7957
71014477|NCT05966129|141535651|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.8255|TWO_SIDED|95.0|-0.4|0.5|||t-test, 2 sided||||Confidence Interval Width = 0.9|0.5|-0.4|0.8255
71014478|NCT05966129|141535652|SUPERIORITY|||||||0.9054|||||||Wilcoxon (Mann-Whitney)|||||||0.9054
71014479|NCT05966129|141535653|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.248|TWO_SIDED|95.0|-1.9|0.5|||t-test, 2 sided||||Confidence Interval Width = 2.4|0.5|-1.9|0.248
71014480|NCT05966129|141535654|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.6012|TWO_SIDED|95.0|-2.7|4.7|||t-test, 2 sided||||Confidence Interval Width = 7.4|4.7|-2.7|0.6012
71014481|NCT05966129|141535655|SUPERIORITY|||||||0.7528|||||||Chi-squared|||||||0.7528
71014482|NCT05966129|141535656|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71014483|NCT01298323|141535657|SUPERIORITY_OR_OTHER_LEGACY||t-Statistic|1.29||||0.199|TWO_SIDED|95.0|-3.44|16.37||Statistical significance threshold at this analysis was 10%|t-test, 2 sided|||||16.37|-3.44|0.199
71014484|NCT04089566|141535658|SUPERIORITY|The Analysis of Covariance (ANCOVA) model used rank score as response, treatment as fixed effect and disease duration at screening, baseline Hammersmith Infant Neurological Examination (HINE) Section 2 (HINE 2), baseline CHOP INTEND total score as covariates.|Least square (LS) mean difference|26.06|STANDARD_ERROR_OF_MEAN|4.141|<|0.0001|TWO_SIDED|95.0|17.941|34.172|||ANCOVA|||||34.172|17.941|< 0.0001
71014485|NCT04089566|141535681|SUPERIORITY||Difference of percentages|58.0|||<|0.0001|TWO_SIDED|95.0|39.46|71.81|||Fisher Exact||Exact unconditional confidence interval|||71.81|39.46|<0.0001
70850594|NCT02712047|141189436|OTHER||Ratio|0.83|||||TWO_SIDED|95.0|0.55|1.25|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 22, AM|||1.25|0.55|
71014486|NCT04089566|141535682|SUPERIORITY||LS mean difference|26.67|STANDARD_ERROR_OF_MEAN|4.009|<|0.0001|TWO_SIDED|95.0|18.812|34.526||ANCOVA model was used treatment as fixed effect and disease duration at screening, baseline HINE 2, baseline CHOP INTEND total score as covariates.|ANCOVA|||||34.526|18.812|<0.0001
71049069|NCT02944383|141606137|SUPERIORITY||Median Difference (Net)|1.51||||0.1379|TWO_SIDED|95.0|-6.26|8.73||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||8.73|-6.26|0.1379
71014487|NCT04089566|141535683|SUPERIORITY||LS geometric mean ratio|0.08|||<|0.0001||||||ANCOVA model was used with treatment as a fixed effect and adjusted for each participant disease duration at screening, baseline log plasma NF-L and baseline CHOP INTEND total score.|ANCOVA|||||||<0.0001
71014488|NCT04089566|141535684|SUPERIORITY||LS mean difference|1.0|STANDARD_ERROR_OF_MEAN|5.251|=|0.8484|TWO_SIDED|95.0|-9.29|11.299||ANCOVA model used rank score as response, treatment as fixed effect and disease duration at screening, baseline HINE 2, baseline CHOP INTEND total score as covariates.|ANCOVA|||||11.299|-9.29|=0.8484
71014489|NCT04089566|141535685|SUPERIORITY||LS mean difference|6.12|STANDARD_ERROR_OF_MEAN|4.497|=|0.1734|TWO_SIDED|95.0|-2.693|14.939||ANCOVA model used rank score as response, treatment as fixed effect and disease duration at screening, baseline HINE 2, baseline CHOP INTEND total score as covariates.|ANCOVA|||||14.939|-2.693|=0.1734
71014490|NCT04089566|141535686|SUPERIORITY||LS geometric mean ratio|0.51|||=|0.002|TWO_SIDED|95.0|0.33|0.78||ANCOVA model was used with treatment as a fixed effect and adjustment for each participant disease duration at screening, baseline log plasma NF-L and baseline CHOP INTEND total score.|ANCOVA|||||0.78|0.33|=0.002
71014491|NCT04089566|141535729|SUPERIORITY||LS geometric mean ratio|0.86|||=|0.3785|TWO_SIDED|95.0|0.62|1.2||ANCOVA model was used with treatment as a fixed effect and adjusted for each participant disease duration at screening, baseline log CSF NF-L and baseline CHOP INTEND total score.|ANCOVA|||||1.2|0.62|=0.3785
71014492|NCT03677440|141535753|SUPERIORITY|||||||0.34|||||||ANOVA|||This involves a repeated-measures ANOVA testing a condition (i.e., treadmill walking exercise training vs. stretching-and-toning exercise training)-by-time (i.e., baseline, follow-up) interaction on Symbol Digit Modalities Test scores.||||.34
71014493|NCT03677440|141535754|SUPERIORITY|||||||0.01|||||||t-test, 1 sided|||||||.01
71014494|NCT03677440|141535755|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||||||.02
71014495|NCT03677440|141535756|SUPERIORITY|||||||0.63|||||||ANOVA|||||||.63
71104425|NCT01765400|141716038|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
70850595|NCT02712047|141189436|OTHER||Ratio|0.77|||||TWO_SIDED|95.0|0.51|1.16|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 22, PM|||1.16|0.51|
71014496|NCT03677440|141535757|SUPERIORITY||Partial eta-squared|0.067||||0.2|TWO_SIDED||||||ANOVA|||||||.20
71014497|NCT03677440|141535758|SUPERIORITY|||||||0.96|||||||ANOVA|||||||.96
71014498|NCT03677440|141535759|SUPERIORITY|||||||0.55|||||||ANOVA|||||||.55
71014499|NCT03677440|141535760|SUPERIORITY||Partial eta-squared|0.087||||0.14|TWO_SIDED||||||ANOVA|||||||.14
71014500|NCT03677440|141535761|SUPERIORITY|||||||0.69|||||||ANOVA|||||||.69
71014501|NCT03677440|141535762|SUPERIORITY||Partial eta-squared|0.048||||0.28|TWO_SIDED||||||ANOVA|||||||.28
71014502|NCT01875731|141535820|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.09||||0.01|TWO_SIDED|95.0|1.57|16.8|||Chi-squared|||||16.8|1.57|0.01
71014503|NCT01875731|141535821|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.71|TWO_SIDED|95.0|0.1|4.09|||Chi-squared|||||4.09|0.1|0.71
71014504|NCT01375491|141535828|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||See published paper.|ANOVA|See published paper.||See published paper.||||<0.05
71014505|NCT01740297|141535976|SUPERIORITY||Odds Ratio (OR)|2.9||||0.002|TWO_SIDED|95.0|1.5|5.5|||Chi-squared, Corrected||Obtained from the unstratified logistic regression model.|||5.5|1.5|0.002
71117596|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
71014506|NCT01740297|141535979|OTHER||Odds Ratio (OR)|1.9||||0.033|TWO_SIDED|95.0|1.1|3.4||P-value is descriptive|Chi-squared, Corrected||Obtained from the unstratified logistic regression model.|||3.4|1.1|0.033
71014507|NCT01740297|141535980|OTHER||Odds Ratio (OR)|2.8||||0.007|TWO_SIDED|95.0|1.4|5.8||P-value is descriptive.|Chi-squared, Corrected||Obtained from the unstratified logistic regression model.|||5.8|1.4|0.007
71014508|NCT01740297|141535981|OTHER||Hazard Ratio (HR)|1.41||||0.228|TWO_SIDED|95.0|0.8|2.49||P-value is descriptive|Log Rank||Obtained from unstratified Cox Proportional Hazard Model.|||2.49|0.80|0.228
71014509|NCT01740297|141535983|OTHER||Hazard Ratio (HR)|0.83||||0.348|TWO_SIDED|95.0|0.56|1.23|||Log Rank||Obtained from unstratified Cox Proportional Hazard Model|||1.23|0.56|0.348
71014510|NCT01740297|141535984|OTHER|||||||0.696|||||||Chi-squared, Corrected|||||||0.696
71014511|NCT01740297|141535985|OTHER||Hazard Ratio (HR)|0.8||||0.474|TWO_SIDED|95.0|0.44|1.46|||Log Rank||Obtained from unstratified Cox Proportional Hazard Model|||1.46|0.44|0.474
71014512|NCT01740297|141535987|OTHER||Hazard Ratio (HR)|0.78||||0.14|TWO_SIDED|95.0|0.55|1.09|||Log Rank||Obtained from unstratified Cox Proportional Hazard Model|||1.09|0.55|0.14
71014513|NCT01740297|141535988|OTHER||Hazard Ratio (HR)|0.83||||0.37|TWO_SIDED|95.0|0.56|1.24|||Log Rank||Obtained from unstratified Cox Proportional Hazard Model|||1.24|0.56|0.37
71014514|NCT01966458|141536015|NON_INFERIORITY|A non-inferiority margin of 6% was pre-specified.|Risk Difference (RD)|2.6||||0.1444|TWO_SIDED|90.0|-5.5|10.7|||Farrington-Manning asymptotic test||Difference = HeartWare® VAS incidence rate - Control incidence rate Two-sided 90% exact binomial confident interval is used.|The primary endpoint is a non-inferiority test comparing HeartWare® VAS to Control.||10.7|-5.5|0.1444
71049070|NCT02944383|141606137|SUPERIORITY||Median Difference (Net)|-6.02||||0.249|TWO_SIDED|95.0|-13.1|0.51||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||0.51|-13.10|0.2490
71014515|NCT01966458|141536016|SUPERIORITY||Percent of Participants|19.2||||0.7363|TWO_SIDED|90.0|15.6|23.3|||Exact Binomial Test||Two-sided exact binomial confidence interval used|The first secondary endpoint is the percent of participants with stroke/TIA at 12 months on the originally implanted device. It will be compared to 17.7%, which is the lower bound of a pre-defined margin of superiority based on the Endurance clinical trial.||23.3|15.6|0.7363
71014516|NCT01966458|141536017|NON_INFERIORITY|The non-inferiority margin on the difference in success proportions is 15%.|Difference in Percentages|-9.2|||<|0.0001|TWO_SIDED|90.0|-17.2|-1.1|||Farrington-Manning asymptotic test||Difference = Control success rate - HeartWare® VAS success rate Two-sided 90% exact binomial confidence interval is used|||-1.1|-17.2|<0.0001
71014517|NCT01966458|141536017|SUPERIORITY|||||||0.0354|||||||Chi-squared|||||||0.0354
71014518|NCT02389621|141536018|SUPERIORITY||Difference|36.7|||<|0.0001|TWO_SIDED|95.0|24.9|48.5||Statistical tests were performed at a 2-sided significance level of 0.05.|Cochran-Mantel-Haenszel|Adjusted using the stratification factors of platelet count at randomization and the planned primary invasive procedure.||||48.5|24.9|<0.0001
71014519|NCT02389621|141536019|SUPERIORITY|A gatekeeping procedure was employed for sequentially testing the prespecified important secondary endpoints, identified as the most clinically relevant endpoints. If the primary endpoint was statistically significant, the secondary endpoints were tested at the 0.05 level (2-sided) in sequence.|Difference|34.8|||<|0.0001|TWO_SIDED|95.0|22.8|46.8|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors of platelet count at randomization and the planned primary invasive procedure.||||46.8|22.8|<0.0001
71014520|NCT02389621|141536020|SUPERIORITY|A gatekeeping procedure was employed for sequentially testing the prespecified important secondary endpoints, identified as the most clinically relevant endpoints. If the primary endpoint was statistically significant, the secondary endpoints were tested at the 0.05 level (2-sided) in sequence.|Difference|52.5|||<|0.0001|TWO_SIDED|95.0|42.0|62.9|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors of platelet count at randomization and the planned primary invasive procedure.||||62.9|42.0|<0.0001
71014521|NCT02389621|141536021|SUPERIORITY|A gatekeeping procedure was employed for sequentially testing the prespecified important secondary endpoints, identified as the most clinically relevant endpoints. If the primary endpoint was statistically significant, the secondary endpoints were tested at the 0.05 level (2-sided) in sequence.||||||0.0002|||||||van Elteren test|van Elteren test stratified by platelet transfusion during the study.||||||0.0002
71014522|NCT02389621|141536022|SUPERIORITY|A gatekeeping procedure was employed for sequentially testing the prespecified important secondary endpoints, identified as the most clinically relevant endpoints. If the primary endpoint was statistically significant, the secondary endpoints were tested at the 0.05 level (2-sided) in sequence.|||||<|0.0001|||||||Wilcoxon rank sum test|||||||<0.0001
71014523|NCT01969201|141536090|NON_INFERIORITY|The non-inferiority was evaluated by calculating the 95% CI for the differences in pregnancy rates between the two treatment groups. If the lower bound of the 95% CI of the difference between the two proportions was greater than -0.10 (i.e. 10%), then Fostimon was to be considered not inferior to the control treatment.|Mean Difference (Final Values)|-2.73||||0.49|TWO_SIDED|95.0|-9.88|4.42|||Fisher Exact|||||4.42|-9.88|0.49
71049071|NCT02944383|141606138|SUPERIORITY|||||||0.155||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1550
71014524|NCT01969201|141536091|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71014525|NCT01969201|141536092|OTHER|||||||0.02|||||||ANOVA|||||||0.02
71014526|NCT01969201|141536093|OTHER|||||||0.32|||||||ANOVA|||||||0.32
71014527|NCT01969201|141536094|OTHER|||||||0.89|||||||ANOVA|||||||0.89
71014528|NCT01969201|141536095|OTHER|||||||0.5|||||||Fisher Exact|||||||0.5
71049072|NCT02944383|141606138|SUPERIORITY|||||||0.6604||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.6604
71049073|NCT02944383|141606138|SUPERIORITY|||||||0.0952||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0952
71117597|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
71014529|NCT01969201|141536096|OTHER|||||||0.53|||||||Fisher Exact|||||||0.53
70850596|NCT02712047|141189436|OTHER||Ratio|0.99|||||TWO_SIDED|95.0|0.66|1.49|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 23, AM|||1.49|0.66|
71014530|NCT01969201|141536097|OTHER|||||||0.07|||||||Fisher Exact|||||||0.07
71014531|NCT01422876|141536111|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.58|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.75|-0.41|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0038), geographical region (p\<0.0001), treatment (p\<0.0001) as fixed effect(s).||-0.41|-0.75|<0.0001
71049074|NCT02944383|141606138|SUPERIORITY|||||||0.3006||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3006
71049075|NCT02944383|141606138|SUPERIORITY|||||||0.0642||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0642
71049076|NCT02944383|141606138|SUPERIORITY|||||||0.3185||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.3185
71014532|NCT01422876|141536111|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.67|-0.32|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0038), geographical region (p\<0.0001), treatment (p\<0.0001) as fixed effect(s).||-0.32|-0.67|<0.0001
71014533|NCT01422876|141536111|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.59|-0.25|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0038), geographical region (p\<0.0001), treatment (p\<0.0001) as fixed effect(s).||-0.25|-0.59|<0.0001
71014534|NCT01422876|141536111|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.56|-0.21|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0038), geographical region (p\<0.0001), treatment (p\<0.0001) as fixed effect(s).||-0.21|-0.56|<0.0001
71014535|NCT01422876|141536112|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.43|STANDARD_ERROR_OF_MEAN|3.54|<|0.0001|TWO_SIDED|95.0|-23.37|-9.48|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.6082) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0104), treatment (p\<0.0001) as fixed effect(s).||-9.48|-23.37|<0.0001
71014536|NCT01422876|141536112|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.2|STANDARD_ERROR_OF_MEAN|3.62|<|0.0001|TWO_SIDED|95.0|-29.3|-15.1|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.6082) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0104), treatment (p\<0.0001) as fixed effect(s).||-15.10|-29.30|<0.0001
71014537|NCT01422876|141536112|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.34|STANDARD_ERROR_OF_MEAN|3.55||0.0015|TWO_SIDED|95.0|-18.31|-4.37|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.6082) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0104), treatment (p\<0.0001) as fixed effect(s).||-4.37|-18.31|0.0015
71014538|NCT01422876|141536112|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.12|STANDARD_ERROR_OF_MEAN|3.61|<|0.0001|TWO_SIDED|95.0|-26.21|-12.03|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.6082) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0104), treatment (p\<0.0001) as fixed effect(s).||-12.03|-26.21|<0.0001
71014539|NCT01422876|141536113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.31|STANDARD_ERROR_OF_MEAN|3.78||0.1605|TWO_SIDED|95.0|-12.74|2.11|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.4591) as linear covariate(s) and baseline eGFR (MDRD) (p=0.7413), geographical region (p=0.1504), treatment (p\<0.0001) as fixed effect(s).||2.11|-12.74|0.1605
71014540|NCT01422876|141536113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.82|STANDARD_ERROR_OF_MEAN|3.78||0.1246|TWO_SIDED|95.0|-13.25|1.61|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.4591) as linear covariate(s) and baseline eGFR (MDRD) (p=0.7413), geographical region (p=0.1504), treatment (p\<0.0001) as fixed effect(s).||1.61|-13.25|0.1246
71014541|NCT01422876|141536113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.63|STANDARD_ERROR_OF_MEAN|3.78|<|0.0001|TWO_SIDED|95.0|-31.06|-16.21|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.4591) as linear covariate(s) and baseline eGFR (MDRD) (p=0.7413), geographical region (p=0.1504), treatment (p\<0.0001) as fixed effect(s).||-16.21|-31.06|<0.0001
71014542|NCT01422876|141536113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.29|STANDARD_ERROR_OF_MEAN|3.77|<|0.0001|TWO_SIDED|95.0|-29.71|-14.88|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.4591) as linear covariate(s) and baseline eGFR (MDRD) (p=0.7413), geographical region (p=0.1504), treatment (p\<0.0001) as fixed effect(s).||-14.88|-29.71|<0.0001
71049077|NCT02944383|141606139|SUPERIORITY|||||||0.0679||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0679
71014543|NCT01422876|141536114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.19|STANDARD_ERROR_OF_MEAN|0.43||0.6604|TWO_SIDED|95.0|-0.65|1.03||Not an alpha protected test.|ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.1610) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0162), treatment (p\<0.0001) as fixed effect(s).||1.03|-0.65|0.6604
71014544|NCT01422876|141536114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|-3.15|-1.44|||ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.1610) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0162), treatment (p\<0.0001) as fixed effect(s).||-1.44|-3.15|<0.0001
71014545|NCT01422876|141536114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.43||0.8757|TWO_SIDED|95.0|-0.91|0.77||Not an alpha protected test.|ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.1610) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0162), treatment (p\<0.0001) as fixed effect(s).||0.77|-0.91|0.8757
71014546|NCT01422876|141536114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.91|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|-2.77|-1.05|||ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.1610) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0162), treatment (p\<0.0001) as fixed effect(s).||-1.05|-2.77|<0.0001
71014547|NCT01422876|141536115|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.1||0.1785|TWO_SIDED|95.0|-0.33|0.06|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.8627), geographical region (p=0.0008), treatment (p\<0.0001) as fixed effect(s).||0.06|-0.33|0.1785
71014548|NCT01422876|141536115|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.61|-0.21|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.8627), geographical region (p=0.0008), treatment (p\<0.0001) as fixed effect(s).||-0.21|-0.61|<0.0001
71049078|NCT02944383|141606139|SUPERIORITY|||||||0.4126||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.4126
70929792|NCT02865538|141357100|OTHER|Descriptive Analysis|LS means difference|1.4|STANDARD_ERROR_OF_MEAN|1.58||0.3796|TWO_SIDED|90.0|-1.2|4.0|||Linear mixed-effects model||Day 7 Change from Day -1|||4.0|-1.2|0.3796
71014549|NCT01422876|141536115|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.61|-0.22|||Cochran-Mantel-Haenszel|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.8627), geographical region (p=0.0008), treatment (p\<0.0001) as fixed effect(s).||-0.22|-0.61|<0.0001
71014550|NCT01422876|141536115|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.76|-0.37|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.8627), geographical region (p=0.0008), treatment (p\<0.0001) as fixed effect(s).||-0.37|-0.76|<0.0001
71014551|NCT01422876|141536116|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.51||0.801|TWO_SIDED|95.0|-0.88|1.14||Not an alpha protected test.|ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.0023) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0316), geographical region (p=0.0134), treatment (p=0.0031) as fixed effect(s).||1.14|-0.88|0.8010
71014552|NCT01422876|141536116|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47|STANDARD_ERROR_OF_MEAN|0.51||0.3616|TWO_SIDED|95.0|-1.48|0.54||Not an alpha protected test.|ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.0023) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0316), geographical region (p=0.0134), treatment (p=0.0031) as fixed effect(s).||0.54|-1.48|0.3616
71014553|NCT01422876|141536116|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.22|STANDARD_ERROR_OF_MEAN|0.51||0.0178|TWO_SIDED|95.0|-2.23|-0.21|||ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.0023) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0316), geographical region (p=0.0134), treatment (p=0.0031) as fixed effect(s).||-0.21|-2.23|0.0178
71014554|NCT01422876|141536116|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.96|STANDARD_ERROR_OF_MEAN|0.51||0.0001|TWO_SIDED|95.0|-2.97|-0.95|||ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.0023) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0316), geographical region (p=0.0134), treatment (p=0.0031) as fixed effect(s).||-0.95|-2.97|0.0001
71014555|NCT01422876|141536117|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.191|||<|0.0001|TWO_SIDED|95.0|2.319|7.573|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||7.573|2.319|<0.0001
71014556|NCT01422876|141536117|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.5|||<|0.0001|TWO_SIDED|95.0|2.474|8.184|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||8.184|2.474|<0.0001
71014557|NCT01422876|141536117|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.495|||<|0.0001|TWO_SIDED|95.0|1.92|6.363|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||6.363|1.920|<0.0001
71014558|NCT01422876|141536117|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.795||||0.0005|TWO_SIDED|95.0|1.562|5.001|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||5.001|1.562|0.0005
71014559|NCT01422876|141536118|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.893||||0.0224|TWO_SIDED|95.0|1.095|3.274|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||3.274|1.095|0.0224
71014560|NCT01422876|141536118|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.961||||0.0001|TWO_SIDED|95.0|1.697|5.169|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||5.169|1.697|0.0001
71014561|NCT01422876|141536118|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.065|||<|0.0001|TWO_SIDED|95.0|1.768|5.314|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||5.314|1.768|<0.0001
71014562|NCT01422876|141536118|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.303|||<|0.0001|TWO_SIDED|95.0|2.462|7.522|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||7.522|2.462|<0.0001
71014563|NCT00620776|141536207|SUPERIORITY_OR_OTHER|||||||0.17|||||||Mixed Models Analysis|||Mixed model analysis (differential slopes over time) comparing the 26 patients who received combined treatment with at least one CBT session to the 35 patients randomized to venlafaxine XR alone (and received at least one dose) on HAM-A total scores. Only available scores were used (no imputation for missing data). Because the HAM-A demonstrated a relatively rapid improvement early in treatment and then a leveling off, a shifted log-transformation of time of assessment was implemented.||||.17
71014564|NCT00620776|141536208|SUPERIORITY_OR_OTHER|||||||0.54|||||||Mixed Models Analysis|||Analyses were conducted using mixed effects models that tested for differential slopes over time between the CBT plus venlafaxine XR and venlafaxine XR alone groups using only available scores (no imputation for missing data).||||.54
70929793|NCT02865538|141357100|OTHER|Descriptive Analysis|LS means difference|-2.3|STANDARD_ERROR_OF_MEAN|1.55||0.1413|TWO_SIDED|90.0|-4.9|0.3|||Linear mixed-effects model||Day 7 Change from Day -1|||0.3|-4.9|0.1413
71014565|NCT00620776|141536209|SUPERIORITY_OR_OTHER|||||||0.86|||||||Mixed Models Analysis|||Analyses were conducted using mixed effects models that tested for differential slopes over time between the CBT plus venlafaxine XR and venlafaxine XR alone groups using only available scores (no imputation for missing data).||||.86
71014566|NCT00620776|141536210|SUPERIORITY_OR_OTHER|||||||0.051|||||||ANCOVA|||Data collected at week 24 were analyzed using analysis of covariance (ANCOVA) with the baseline score as the covariate.||||.051
71014567|NCT00620776|141536211|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANCOVA|||Analyses were conducted using mixed effects models that tested for differential slopes over time between the CBT plus venlafaxine XR and venlafaxine XR alone groups using only available scores (no imputation for missing data).||||.06
71014568|NCT00620776|141536212|SUPERIORITY_OR_OTHER|||||||0.95|||||||Mixed Models Analysis|||Analyses were conducted using mixed effects models that tested for differential slopes over time between the CBT plus venlafaxine XR and venlafaxine XR alone groups using only available scores (no imputation for missing data).||||.95
71014569|NCT00620776|141536213|SUPERIORITY_OR_OTHER|||||||0.17|||||||ANCOVA|||Data collected at week 24 were analyzed using ANCOVA with the baseline score as the covariate.||||.17
71014570|NCT00620776|141536214|SUPERIORITY_OR_OTHER|||||||0.53|||||||ANCOVA|||Data collected at week 24 were analyzed using ANCOVA with the baseline score as the covariate.||||.53
71014571|NCT00620776|141536215|SUPERIORITY_OR_OTHER|||||||0.23|||||||ANCOVA|||Data collected at week 24 were analyzed with ANCOVA with baseline data as covariate.||||.23
71014572|NCT00620776|141536216|SUPERIORITY_OR_OTHER|||||||0.07|||||||ANCOVA|||Data collected at week 24 were analyzed with ANCOVA including baseline data as covariate.||||.07
71014573|NCT00620776|141536217|SUPERIORITY_OR_OTHER|||||||0.63|||||||Chi-squared|||||||.63
71014574|NCT00620776|141536218|SUPERIORITY_OR_OTHER|||||||0.52|||||||Chi-squared|||||||.52
71014575|NCT03992456|141536226|SUPERIORITY|||||||0.5126|||||||Un-Stratified Log-rank|||||||0.5126
71049079|NCT02944383|141606139|SUPERIORITY|||||||0.0095||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0095
71049080|NCT02944383|141606139|SUPERIORITY|||||||0.0172||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0172
71049081|NCT02944383|141606139|SUPERIORITY||Median Difference (Net)|-23.23||||0.0359|TWO_SIDED|95.0|-41.54|-3.64||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-3.64|-41.54|0.0359
71049082|NCT02944383|141606139|SUPERIORITY||Median Difference (Net)|-16.06||||0.0812|TWO_SIDED|95.0|-38.62|5.61||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||5.61|-38.62|0.0812
71104426|NCT03978598|141716047|NON_INFERIORITY|We used a 15% difference in our primary outcome for the non-inferiority margin as this is the upper end of the estimated prevalence of lactation failure in the literature and is consistent with previous studies (Neifert 2001, Gurtcheff 2011, Turok 2017).|Risk Difference (RD)|3.7|||||ONE_SIDED|95.0|-16.7|||||||To achieve 80% power with a 1-sided type 1 error of 5% utilizing the Z-test (unpooled), 62 participants would be required in each group, for a total of 124 participants. Accounting for expected loss to follow-up of 20%, we aimed to recruit 149 participants and rounded up to final recruitment goal of 150.|The risk-difference between immediate and standard placement in the modified intention-to-treat analysis (mITT) was -0.6% with a -12.8% lower limit of the 95% confidence interval. In the mITT analysis, 78.3% (54/69) and 78.9% (45/57) of participants were breastfeeding at 8 weeks in the immediate and delayed groups, respectively.||-16.7|
71104427|NCT01425814|141716100|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.259|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.219|0.298|||ANCOVA|||||0.298|0.219|<0.0001
70850597|NCT02712047|141189436|OTHER||Ratio|0.67|||||TWO_SIDED|95.0|0.29|1.51|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 23, PM|||1.51|0.29|
70850598|NCT02712047|141189436|OTHER||Ratio|0.72|||||TWO_SIDED|95.0|0.32|1.64|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 24, AM|||1.64|0.32|
71014576|NCT03992456|141536227|SUPERIORITY|||||||0.1512|||||||Un-Stratified Log-rank|||||||0.1512
71104428|NCT01425814|141716100|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.233|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.194|0.273|||ANCOVA|||||0.273|0.194|<0.0001
71104429|NCT01425814|141716100|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.203|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.164|0.242|||ANCOVA|||||0.242|0.164|<0.0001
71104430|NCT01425814|141716100|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.102|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.062|0.141|||ANCOVA|||||0.141|0.062|<0.0001
70850599|NCT02712047|141189438|OTHER||Mean Difference (Net)|45.86|||||TWO_SIDED|95.0|23.69|68.03|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 1, AM|||68.03|23.69|
70850600|NCT02712047|141189438|OTHER||Mean Difference (Net)|45.37|||||TWO_SIDED|95.0|23.2|67.55|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 1, PM|||67.55|23.20|
71014577|NCT03992456|141536228|SUPERIORITY|||||||0.2506|||||||Chi-squared|||||||0.2506
71014578|NCT03992456|141536229|SUPERIORITY|||||||0.8865|||||||Chi-squared|||||||0.8865
71014579|NCT03992456|141536230|SUPERIORITY|||||||0.5455|||||||Fisher Exact|||||||0.5455
71014580|NCT04668066|141536294|OTHER||Least Square Mean Difference|5.6||||0.6343|TWO_SIDED|90.0|-21.4|32.6|||ANCOVA|||||32.6|-21.4|0.6343
71014581|NCT00761085|141536295|OTHER|No statistical comparisons||||||||||||||||"No statistical comparisons of methadone concentration in patients receiving methadone vs not receiving methadone (children or adults).~No statistical comparisons of methadone concentration in children vs adults"|No statistical comparisons|||
71014582|NCT00761085|141536296|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71014583|NCT01195662|141536297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.28|STANDARD_ERROR_OF_MEAN|1.1485||0.0002|TWO_SIDED|95.0|-6.54|-2.02||Endpoint was tested at alpha=0.05. Hierarchical closed testing procedure used.|Longitudinal repeated measures|Data from all weeks during the double-blind treatment period were included.||Longitudinal repeated measures analysis using 'direct likelihood', with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata, as well as continuous fixed covariates of baseline SBP value and baseline SBP value-by-week interaction. Unstructured matrix for within-subject error variance-covariance used. 80% power to detect a difference of 4 mmHg in mean change from baseline, 75% power to meet both co-primary endpoints with overall Type I error.||-2.02|-6.54|0.0002
71049083|NCT02944383|141606140|SUPERIORITY|||||||0.1362||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1362
71049084|NCT02944383|141606140|SUPERIORITY|||||||0.6458||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.6458
71049085|NCT02944383|141606140|SUPERIORITY|||||||0.0209||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0209
71014584|NCT01195662|141536298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.0773|<|0.0001|TWO_SIDED|95.0|-0.76|-0.46|||Longitudinal repeated measures|Endpoint was tested at alpha=0.05. Hierarchical closed testing procedure was used.||A longitudinal repeated measures analysis used, with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata, continuous fixed covariates of baseline HbA1c value and baseline HbA1c value-by-week interaction. Only data up to Week 12 included. All data used in the model even if participants discontinued prior to Week 12. A heirarchical closed testing procedure (sequential) was used and testing performed since first primary endpoint was significant.||-0.46|-0.76|<0.0001
71104431|NCT01383005|141716123|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.16||||0.001|TWO_SIDED|95.0|0.052|0.494|||Regression, Logistic|Degree of freedom is 1 for the independent variable 'viral load change from detectable to undetectable.'|Stepwise procedures forward and backward were used to select variables in the model using entry and exit probabilities of 0.05 and 0.1 respectively. Identical models were obtained by forward and backward selection procedures.|Statistical Analysis 1 presents the risk of a 'mean score \<5' on the HIVTSQ overall satisfaction dimension (see Outcome Measure 8) when correlated with a viral load change from 'detectable to undetectable' in the last model of the Wald test.||0.494|0.052|0.001
71104432|NCT01383005|141716123|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.279||||0.072|TWO_SIDED|95.0|0.07|1.118|||Regression, Logistic|Degree of freedom is 1 for the independent variable 'viral load change from undetectable to undetectable.'|Stepwise procedures forward and backward were used to select variables in the model using entry and exit probabilities of 0.05 and 0.1 respectively. Identical models were obtained by forward and backward selection procedures.|Statistical Analysis 2 presents the risk of a 'mean score \<5' on the HIVTSQ overall satisfaction dimension (see Outcome Measure 8) when correlated with a viral load change from 'undetectable to undetectable' in the last model of the Wald test.||1.118|0.070|0.072
70929794|NCT02865538|141357100|OTHER|Descriptive Analysis|LS means difference|-5.5|STANDARD_ERROR_OF_MEAN|1.55||0.0007|TWO_SIDED|90.0|-8.1|-2.9|||Linear mixed-effects model||Day 7 Change from Day -1|||-2.9|-8.1|0.0007
71104433|NCT01383005|141716124|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.996||||0.025|TWO_SIDED|95.0|0.992|0.999|||Regression, Logistic|Degree of freedom is 1 for the independent variable 'time on LPV/r.'|Stepwise procedures forward and backward were used to select variables in the model using entry and exit probabilities of 0.05 and 0.1 respectively. Identical models were obtained by forward and backward selection procedures.|Statistical Analysis 1 presents the risk of a 'mean score \<5' on the HIVTSQ overall satisfaction dimension (see Outcome Measure 8) when correlated with time on treatment with LPV/r QD in the last model of the Wald test.||0.999|0.992|0.025
70929795|NCT02865538|141357100|OTHER|Descriptive Analysis|LS means difference|-3.1|STANDARD_ERROR_OF_MEAN|1.62||0.0624|TWO_SIDED|90.0|-5.8|-0.4|||Linear mixed-effects model||Day 7 Change from Day -1|||-0.4|-5.8|0.0624
71014585|NCT01195662|141536299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.45|STANDARD_ERROR_OF_MEAN|1.368||0.0012|TWO_SIDED|95.0|-7.14|-1.76||Endpoint tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||ANCOVA model with treatment group as an effect and baseline value and randomization strata as a covariate was used. By applying sequential testing procedure, the testing was performed since the prior endpoint was significant.||-1.76|-7.14|0.0012
71014586|NCT01195662|141536300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.69||0.1619|TWO_SIDED|95.0|-2.32|0.39||Endpoint tested following a sequential testing procedure at alpha=0.05.|Longitudinal repeated measures|||Longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by week interaction, and randomization strata and continuous fixed covariates of baseline seated diastolic BP value and baseline seated diastolic BP value by week interaction.||0.39|-2.32|0.1619
71014587|NCT01195662|141536301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99|STANDARD_ERROR_OF_MEAN|0.8635|||TWO_SIDED|95.0|-3.68|-0.29|||ANCOVA|||ANCOVA model with treatment group as an effect and baseline value and randomization strata as a covariate. A hierarchical closed testing procedure was implemented to control the family-wise type I error rate related to the co-primary and secondary endpoints at the 2-sided 0.05 level. Statistical testing of this endpoint was not performed since the prior secondary endpoint was not statistically significant.||-0.29|-3.68|
71014588|NCT01195662|141536302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.0858|||TWO_SIDED|95.0|-0.57|-0.23|||lLongitudinal repeated measures|||Longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by week interaction, and randomization strata and continuous fixed covariates of baseline serum uric acid value and baseline seated serum uric acid value by week interaction. By applying sequential testing procedure at alpha=0.05, no testing was performed since the prior secondary endpoint was not significant.||-0.23|-0.57|
71014589|NCT01215968|141536308|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|2.19|||||TWO_SIDED|90.0|1.83|2.62|||Mixed Linear effects model analyses|Ratio is the Geometric LS Means of Day 10 over Day 3.||||2.62|1.83|
71014590|NCT01215968|141536308|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|1.94|||||TWO_SIDED|90.0|1.61|2.33|||Mixed Linear effects model analyses|Ratio is the Geometric LS Means of Day 17 over Day 3.||||2.33|1.61|
71014591|NCT01215968|141536308|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|1.91|||||TWO_SIDED|90.0|1.59|2.29|||Mixed Linear effects model analyses|Ratio is the Geometric LS Means of Day 24 over Day 3.||||2.29|1.59|
71014592|NCT01215968|141536308|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|1.84|||||TWO_SIDED|90.0|1.52|2.22|||Mixed Linear effects model analyses|Ratio is the Geometric LS Means of Day 31 over Day 3.||||2.22|1.52|
71014593|NCT05643573|141536316|SUPERIORITY||Cox Proportional Hazard|3.785|||<|0.0001|TWO_SIDED|95.0|2.457|5.833|||Log Rank|||Comparison of Asundexian 50 mg verus Apixaban||5.833|2.457|<.0001
71014594|NCT05643573|141536316|SUPERIORITY||Fine-Gray model|3.79|||<|0.0001|TWO_SIDED|95.0|2.46|5.839|||Gray's test|||Comparison of Asundexian 50 mg verus Apixaban||5.839|2.460|<.0001
70929796|NCT02865538|141357100|OTHER|Descriptive Analysis|LS means difference|1.3|STANDARD_ERROR_OF_MEAN|1.21||0.293|TWO_SIDED|90.0|-0.7|3.3|||Linear mixed-effects model||Day 14 Change from Day -1|||3.3|-0.7|0.2930
70929797|NCT02865538|141357100|OTHER|Descriptive Analysis|LS means difference|-2.4|STANDARD_ERROR_OF_MEAN|1.21||0.0512|TWO_SIDED|90.0|-4.4|-0.4|||Linear mixed-effects model||Day 14 Change from Day -1|||-0.4|-4.4|0.0512
71014595|NCT05643573|141536317|SUPERIORITY||Fine-Gray model|0.319|||<|0.0001|TWO_SIDED|95.0|0.185|0.552|||Log Rank|||Comparison of Asundexian 50 mg verus Apixaban||0.552|0.185|<.0001
71049086|NCT02944383|141606140|SUPERIORITY|||||||0.0822||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0822
71049087|NCT02944383|141606140|SUPERIORITY|||||||0.0504||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0504
71049088|NCT02944383|141606140|SUPERIORITY|||||||0.1315||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.1315
71049089|NCT02944383|141606141|SUPERIORITY|||||||0.0843||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0843
71104434|NCT03243084|141716129|SUPERIORITY|||||||0.319||||||Threshold for significance is \<.05.|ANOVA|||A 2x2 ANOVA was used to measure change in HF-HRV by condition (10 Hz vs sham) and session (first vs second) as within subjects variables||||.319
71104435|NCT03243084|141716131|SUPERIORITY|||||||0.0488||||||Threshold for significance is \<.05.|Wilcoxon (Mann-Whitney)|||Investigators hypothesized that active stimulation would have a greater normalized pain change using a modulation index \[(Pre-Post)/(Pre+Post)\]||||.0488
71104436|NCT01137890|141716132|SUPERIORITY||F-value for main effect of Coc dose|24.9|||<|0.01|TWO_SIDED|||||p-value was calculated as less than 0.01. Note: this is not an attempt to indicate a threshold|ANOVA||F-value for main effect of Cocaine dose on VAQ score|||||<0.01
71104437|NCT01137890|141716132|SUPERIORITY||F-value for main effect of Zon dose|0.34||||0.72|TWO_SIDED||||||ANOVA||F-value for main effect of Zonisamide dose on VAQ score|||||0.72
71104438|NCT01137890|141716132|SUPERIORITY||F-value for main effect of Coc x Zon|0.66||||0.63|TWO_SIDED||||||ANOVA||F-value for main effect of Cocaine x Zonisamide interaction on VAQ scores|||||0.63
71104439|NCT01137890|141716133|SUPERIORITY||F-value for main effect of Coc dose|9.91|||<|0.01|TWO_SIDED|||||p-value was calculated as less than 0.01. Note: this is not an attempt to indicate a threshold|ANOVA||F-value for main effect of Cocaine dose on Behavioral Choice measure|||||<0.01
71104440|NCT01137890|141716133|SUPERIORITY||F-value for main effect of Zon dose|0.07||||0.93|TWO_SIDED||||||ANOVA||F-value for main effect of Zonisamide dose on Behavioral Choice measure|||||0.93
71104441|NCT01137890|141716133|SUPERIORITY||F-value for main effect of Coc x Zon|0.24||||0.92|TWO_SIDED||||||ANOVA||F-value for main effect of Cocaine dose x Zonisamide dose interaction on Behavioral Choice measure|||||0.92
71104442|NCT01137890|141716134|SUPERIORITY||t-value for main effect of Group|1.51||||0.16|TWO_SIDED|||||Group (Zonisamide vs Placebo)|t-test, 2 sided|||||||0.16
71049090|NCT02944383|141606141|SUPERIORITY|||||||0.3587||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3587
71049091|NCT02944383|141606141|SUPERIORITY||Median Difference (Net)|12.99||||0.0843|TWO_SIDED|95.0|-0.54|25.51||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||25.51|-0.54|0.0843
71104443|NCT01137890|141716134|SUPERIORITY|Day (Day 1-39)|t-value for main effect of Day|-3.2||||0.0015|TWO_SIDED||||||t-test, 2 sided|||||||0.0015
71104444|NCT01137890|141716134|SUPERIORITY|Group\*Day interaction|t value for Group x Day interaction|-1.63||||0.1|TWO_SIDED||||||t-test, 2 sided|||||||0.10
71104445|NCT01137890|141716135|SUPERIORITY||F-value for main effect of Coc dose|21.1|||<|0.01|TWO_SIDED|||||p-value was calculated as less than 0.01. Note: this is not an attempt to indicate a threshold|ANOVA||F-value for main effect of Cocaine dose|||||<0.01
71104446|NCT01137890|141716135|SUPERIORITY||F-value for main effect of Zon dose|0.77||||0.48|TWO_SIDED||||||ANOVA||F-value for main effect of Zonisamide dose|||||0.48
71104447|NCT01137890|141716135|SUPERIORITY||F-value for the main effect of Zon x Coc|0.93||||0.46|TWO_SIDED||||||ANOVA||F-value for main effect of Zonisamide x Cocaine interaction on drug value (i.e., street value) measurement|||||0.46
71104448|NCT02090764|141716136|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Chi-squared|||The treatment comparison was done using only the outcomes of Clinical success and Clinical failure. The p value of the chi square test (without continuity correction) was provided. The analysis was performed to test the superiority of ozenoxacin versus placebo.||||0.001
71104449|NCT02384421|141716137|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71104450|NCT02384421|141716138|SUPERIORITY|||||||0.0064|||||||t-test, 2 sided|||||||0.0064
71104451|NCT02384421|141716139|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
71104452|NCT02384421|141716140|SUPERIORITY|||||||0.25|||||||Wilcoxon Signed-Rank Test|||||||0.25
71104453|NCT02384421|141716141|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
71104454|NCT02384421|141716142|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71104455|NCT02300233|141716143|SUPERIORITY||Difference in Least Squares Mean (LSM)|-70.3|||<|0.0001|TWO_SIDED|95.0|-85.4|-55.3|||ANCOVA|||||-55.3|-85.4|<0.0001
70850601|NCT02712047|141189438|OTHER||Mean Difference (Net)|34.03|||||TWO_SIDED|95.0|11.86|56.21|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 2, AM|||56.21|11.86|
71104456|NCT02300233|141716144|SUPERIORITY||Difference in LSM|-943.0|||<|0.0001|TWO_SIDED|95.0|-1197.0|-689.0|||ANCOVA|||||-689|-1197|<0.0001
71104457|NCT02300233|141716145|SUPERIORITY||Odds Ratio (OR)|96.02|||<|0.0001|TWO_SIDED|95.0|19.71|467.79|||Regression, Logistic|||||467.79|19.71|<0.0001
71104458|NCT02300233|141716146|SUPERIORITY||Difference in LSM|56.8|||<|0.0001|TWO_SIDED|95.0|45.1|68.6|||ANCOVA|||||68.6|45.1|<0.0001
71104459|NCT02300233|141716147|SUPERIORITY||Odds Ratio (OR)|14.93||||0.0474|TWO_SIDED|95.0|1.03|215.88|||Regression, Logistic|||||215.88|1.03|0.0474
71014596|NCT05643573|141536317|SUPERIORITY||Fine-Gray model|0.316|||<|0.0001|TWO_SIDED|95.0|0.182|0.547|||Gray's test|||Comparison of Asundexian 50 mg verus Apixaban||0.547|0.182|<.0001
71014597|NCT05643573|141536318|SUPERIORITY||Fine-Gray model|1.61||||0.0011|TWO_SIDED|95.0|1.207|2.149|||Log Rank|||Comparison of Asundexian 50 mg verus Apixaban||2.149|1.207|0.0011
71014598|NCT05643573|141536318|SUPERIORITY||Fine-Gray model|1.599||||0.0013|TWO_SIDED|95.0|1.197|2.134|||Gray's test|||Comparison of Asundexian 50 mg verus Apixaban||2.134|1.197|0.0013
71014599|NCT03378921|141536357|SUPERIORITY|||||||0.183||||||The threshold for statistical significance was P = 0.05|Log Rank|||The sample size (n = 26) was calculated according to the estimation that the remission rate in the FMT group would be 80% and 25% in the placebo group during the follow-up of 1 year. This difference of 55% was considered to be clinically meaningful. The significance level was selected to be 1%, and the power was set to 90%.||||0.183
71014600|NCT05689554|141536379|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.11|TWO_SIDED|95.0|0.944|1.306|||Log Rank|||||1.306|.944|0.11
71014601|NCT05689554|141536380|SUPERIORITY||Risk Ratio (RR)|1.24||||0.183|TWO_SIDED|95.0|0.9|1.7|||Regression, modified Poisson|||||1.7|.9|0.183
71014602|NCT01441882|141536381|NON_INFERIORITY|A non-parametric two-sided Mann-Whitney test was run assuming non-Gaussian distributions. Two-tailed with 95% confidence intervals.||||||0.0106|TWO_SIDED|95.0|||||t-test, 2 sided|Threshold for statistical significance is 0.05.||Percent change from baseline in responders compared to non-responders (lymph node size).||||0.0106
71014603|NCT01441882|141536381|NON_INFERIORITY|A non-parametric two-sided Mann-Whitney test was run assuming non-Gaussian distributions. Two-tailed with 95% confidence intervals.||||||0.1986|TWO_SIDED|95.0|||||t-test, 2 sided|Threshold for statistical significance is 0.05.||Percent change from baseline in responders compared to non-responders (Absolute Lymphocyte Count (ALC)).||||0.19860
71014604|NCT01441882|141536381|NON_INFERIORITY|A non-parametric two-sided Mann-Whitney test was run assuming non-Gaussian distributions. Two-tailed with 95% confidence intervals.||||||0.5167|TWO_SIDED|95.0|||||t-test, 2 sided|Threshold for statistical significance is 0.05.||Percent change from baseline in responders compared to non-responders (spleen size).||||0.5167
71014605|NCT00437294|141536414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.237||||||The 1-sided significance level was 0.20.|Log Rank|||||||0.237
71014606|NCT00437294|141536419|SUPERIORITY_OR_OTHER_LEGACY|||||||1||||||1-sided significance level was 0.20.|Fisher Exact|||||||1.00
71014607|NCT00437294|141536420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.812|||||||Log Rank|||||||0.812
70929798|NCT02865538|141357100|OTHER|Descriptive Analysis|LS means difference|-5.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|90.0|-7.0|-3.0|||Linear mixed-effects model||Day 14 Change from Day -1|||-3.0|-7.0|<0.0001
71014608|NCT00437294|141536421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.181|||||||Log Rank|||||||0.181
71014609|NCT02277665|141536425|SUPERIORITY|Chi-square|Odds Ratio (OR)|0.56|||=|0.33|TWO_SIDED|95.0|0.17|1.82|||Chi-squared|||||1.82|.17|= 0.33
71014610|NCT02277665|141536426|OTHER||Odds Ratio (OR)|0.32||||0.57|TWO_SIDED||||||Chi-squared|||||||0.57
71014611|NCT02277665|141536427|OTHER||Odds Ratio (OR)|0.45|||=|0.16|TWO_SIDED|95.0|0.15|1.35|||Chi-squared|||||1.35|0.15|= 0.16
71014612|NCT02277665|141536428|SUPERIORITY||Means Ratio|0.97||||0.87|TWO_SIDED|95.0|0.66|1.42|||Chi-squared|||||1.42|0.66|0.87
71014613|NCT02277665|141536429|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
71014614|NCT02277665|141536430|SUPERIORITY|||||||0.04|||||||Chi-squared|||||||0.04
71014615|NCT01453296|141536476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||||TWO_SIDED|95.0|-0.8|5.7|||||Day 1 maximum HR (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||5.7|-0.8|
71014616|NCT01453296|141536476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-2.4|3.7|||||Day 14 maximum HR (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||3.7|-2.4|
71014617|NCT01453296|141536476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-2.6|3.6|||||Day 14 maximum HR (0-8 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||3.6|-2.6|
71014618|NCT01453296|141536477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||||TWO_SIDED|95.0|-0.8|5.7|||||Day 1 weighted HR (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||5.7|-0.8|
71014619|NCT01453296|141536477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-2.4|3.7|||||Day 14 weighted HR (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||3.7|-2.4|
71014620|NCT01453296|141536477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-2.6|3.6|||||Day 14 weighted HR (0-8 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||3.6|-2.6|
71014621|NCT01453296|141536478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-4.5|6.6|||||Day 1 maximum QTcF (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||6.6|-4.5|
71014622|NCT01453296|141536478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|||||TWO_SIDED|95.0|-3.2|6.3|||||Day 14 maximum QTcF (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||6.3|-3.2|
71014623|NCT01453296|141536478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-3.0|5.7|||||Day 14 maximum QTcF (0-8 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||5.7|-3.0|
71014624|NCT01453296|141536492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.01|||||TWO_SIDED|95.0|-2.59|6.61|||||Day 1 weighted QTcF (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||6.61|-2.59|
71014625|NCT01453296|141536492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.94|||||TWO_SIDED|95.0|-1.93|7.81|||||Day 14 weighted QTcF (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||7.81|-1.93|
71014626|NCT01453296|141536492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.19|||||TWO_SIDED|95.0|-0.7|7.08|||||Day 14 weighted QTcF (0-8 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||7.08|-0.70|
70929799|NCT02865538|141357100|OTHER|Descriptive Analysis|LS means difference|-3.4|STANDARD_ERROR_OF_MEAN|1.25||0.008|TWO_SIDED|90.0|-5.5|-1.3|||Linear mixed-effects model||Day 14 Change from Day -1|||-1.3|-5.5|0.0080
70929800|NCT02865538|141357101|OTHER|Descriptive Analysis|LS means difference|0.84|STANDARD_ERROR_OF_MEAN|0.574||0.1482|TWO_SIDED|90.0|-0.12|1.8|||Linear mixed-effects model||Change from Week -1 to Week 1|||1.80|-0.12|0.1482
70929801|NCT02865538|141357101|OTHER|Descriptive Analysis|LS means difference|-1.04|STANDARD_ERROR_OF_MEAN|0.571||0.0734|TWO_SIDED|90.0|-1.99|-0.09|||Linear mixed-effects model||Change from Week -1 to Week 1|||-0.09|-1.99|0.0734
70929802|NCT02865538|141357101|OTHER|Descriptive Analysis|LS means difference|-1.8|STANDARD_ERROR_OF_MEAN|0.565||0.0022|TWO_SIDED|90.0|-2.74|-0.86|||Linear mixed-effects model||Change from Week -1 to Week 1|||-0.86|-2.74|0.0022
70929803|NCT02865538|141357101|OTHER|Descriptive Analysis|LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.589||0.066|TWO_SIDED|90.0|-2.08|-0.12|||Linear mixed-effects model||Change from Week -1 to Week 1|||-0.12|-2.08|0.0660
70929804|NCT02865538|141357101|OTHER|Descriptive Analysis|LS means difference|1.18|STANDARD_ERROR_OF_MEAN|0.613||0.0593|TWO_SIDED|90.0|0.15|2.2|||Linear mixed-effects model||||Change from Week -1 to Week 2|2.20|0.15|0.0593
70929805|NCT02865538|141357101|OTHER||LS means difference|-0.93|STANDARD_ERROR_OF_MEAN|0.614||0.1354|TWO_SIDED|90.0|-1.95|0.1|||Linear mixed-effects model||Change from Week -1 to Week 2|||0.10|-1.95|0.1354
70929806|NCT02865538|141357101|OTHER|Descriptive Analysis|LS means difference|-2.2|STANDARD_ERROR_OF_MEAN|0.603||0.0005|TWO_SIDED|90.0|-3.21|-1.2|||Linear mixed-effects model||Change from Week -1 to Week 2|||-1.20|-3.21|0.0005
71014627|NCT03557775|141536493|SUPERIORITY|||||||0.041||||||Result for time by group interaction (threshold for statistical significance set at 0.05).|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.041
71014628|NCT03557775|141536494|SUPERIORITY|||||||0.887||||||Result for time by group interaction. Statistical threshold set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.887
71049092|NCT02944383|141606141|SUPERIORITY||Median Difference (Net)|7.98||||0.3587|TWO_SIDED|95.0|-3.7|21.39||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||21.39|-3.70|0.3587
70929807|NCT02865538|141357101|OTHER|Descriptive Analysis|LS means difference|-1.38|STANDARD_ERROR_OF_MEAN|0.628||0.0309|TWO_SIDED|90.0|-2.43|-0.34|||Linear mixed-effects model||Change from Week -1 to Week 2|||-0.34|-2.43|0.0309
70929808|NCT02865538|141357102|OTHER|Descriptive analysis|LS means difference|-9.7|STANDARD_ERROR_OF_MEAN|10.88||0.3768|TWO_SIDED|90.0|-27.8|8.5|||Linear mixed-effects model||Change from Day -1 to Day 1|||8.5|-27.8|0.3768
70929809|NCT02865538|141357102|OTHER|Descriptive analysis|LS means difference|-25.0|STANDARD_ERROR_OF_MEAN|10.89||0.0248|TWO_SIDED|90.0|-43.1|-6.8|||Linear mixed-effects model||Change from Day -1 to Day 1|||-6.8|-43.1|0.0248
70929810|NCT02865538|141357102|OTHER|Descriptive analysis|LS means difference|-43.9|STANDARD_ERROR_OF_MEAN|10.9||0.0001|TWO_SIDED|90.0|-62.1|-25.8|||Linear mixed-effects model||Change from Day -1 to Day 1|||-25.8|-62.1|0.0001
70929811|NCT02865538|141357102|OTHER|Descriptive analysis|LS means difference|-42.9|STANDARD_ERROR_OF_MEAN|11.43||0.0004|TWO_SIDED|90.0|-61.9|-23.8|||Linear mixed-effects model||Change from Day -1 to Day 1|||-23.8|-61.9|0.0004
70929812|NCT02865538|141357102|OTHER|Descriptive analysis|LS means difference|10.4|STANDARD_ERROR_OF_MEAN|14.76||0.4819|TWO_SIDED|90.0|-14.2|35.1|||Linear mixed-effects model||Change from Day -1 to Day 7|||35.1|-14.2|0.4819
70929813|NCT02865538|141357102|OTHER|Descriptive analysis|LS means difference|-2.4|STANDARD_ERROR_OF_MEAN|14.77||0.8694|TWO_SIDED|90.0|-27.1|22.2|||Linear mixed-effects model||Change from Day -1 to Day 7|||22.2|-27.1|0.8694
70929814|NCT02865538|141357102|OTHER|Descriptive analysis|LS means difference|-23.9|STANDARD_ERROR_OF_MEAN|14.79||0.1105|TWO_SIDED|90.0|-48.6|0.7|||Linear mixed-effects model||Change from Day -1 to Day 7|||0.7|-48.6|0.1105
70929815|NCT02865538|141357102|OTHER|Descriptive analysis|LS means difference|-18.4|STANDARD_ERROR_OF_MEAN|15.5||0.239|TWO_SIDED|90.0|-44.2|7.4|||Linear mixed-effects model||Change from Day -1 to Day 7|||7.4|-44.2|0.2390
70929816|NCT03106740|141357103|SUPERIORITY|Because relevant \[11C\]PBR28 PET imaging data were unavailable at the time of trial initiation to inform a power analysis of a treatment effect, we ran a power analysis of the treatment effect on the expected change in pain ratings based on a recent clinical trial using minocycline in subjects with back pain. We computed the sample size required for mixed effects between-subject and within-subject (Time: Pretest/Posttest) repeated measures ANOVA design. Alpha was set at 0.05 (two-tailed test).|Restricted maximum likelihood|0.0||||0.956|TWO_SIDED|95.0|-0.02|0.02||The p-value corresponds to the group-by-time interaction analysis of the primary outcome measure.|Mixed Models Analysis||Estimation parameter: Unstandardized partial regression coefficient (beta)|||0.02|-0.02|0.956
70929817|NCT04797858|141357111|SUPERIORITY||Risk Difference (RD)|0.0077||||0.45|TWO_SIDED|95.0|-0.021|0.056|||Fisher Exact|||||0.056|-0.021|0.45
70929818|NCT04797858|141357112|SUPERIORITY||Risk Difference (RD)|0.015||||0.11|TWO_SIDED|95.0|-0.0004|0.03|||Fisher Exact|||||0.03|-0.0004|0.11
70929819|NCT05423730|141357127|SUPERIORITY||Mean Difference (Final Values)|-11.12|||||TWO_SIDED|95.0|-49.75|57.2|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||57.20|-49.75|
70929820|NCT05423730|141357128|SUPERIORITY||Mean Difference (Final Values)|7.65|||||TWO_SIDED|95.0|-47.96|63.9|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||63.90|-47.96|
70929821|NCT05423730|141357129|SUPERIORITY||Mean Difference (Final Values)|-0.65|||||TWO_SIDED|95.0|-1.95|0.67|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||0.67|-1.95|
71014629|NCT03557775|141536495|SUPERIORITY|||||||0.733||||||Result for time by group interaction effect. Threshold for statistical significance was set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.733
70929822|NCT05423730|141357130|SUPERIORITY||Mean Difference (Final Values)|13.83|||||TWO_SIDED|95.0|-9.45|43.09|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||43.09|-9.45|
70929823|NCT05423730|141357131|SUPERIORITY||Mean Difference (Final Values)|11.42|||||TWO_SIDED|95.0|-3.31|28.4|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||28.40|-3.31|
71014630|NCT03557775|141536496|SUPERIORITY|||||||0.702||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.702
71014631|NCT03557775|141536497|SUPERIORITY|||||||0.198||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.198
71014632|NCT03557775|141536498|SUPERIORITY|||||||0.388||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.388
71014633|NCT03557775|141536499|SUPERIORITY|||||||0.296||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.296
71014634|NCT03557775|141536500|SUPERIORITY|||||||0.04||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.040
71014635|NCT03557775|141536501|SUPERIORITY|||||||0.887||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.887
71014636|NCT03557775|141536502|SUPERIORITY|||||||0.663||||||Result for time by group interaction effect. Threshold for statistical significance was set 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.663
71014637|NCT03557775|141536503|SUPERIORITY|||||||0.026||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.026
71014638|NCT03557775|141536504|SUPERIORITY|||||||0.721||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.721
71014639|NCT03557775|141536505|SUPERIORITY|||||||0.408||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.408
71049093|NCT02944383|141606142|SUPERIORITY|||||||0.0768||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0768
71014640|NCT03557775|141536506|SUPERIORITY|||||||0.638||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.638
71014641|NCT03557775|141536507|SUPERIORITY|||||||0.715||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.715
71049094|NCT02944383|141606142|SUPERIORITY|||||||0.4346||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4346
71049095|NCT02944383|141606142|SUPERIORITY|||||||0.0768||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0768
71104460|NCT04752566|141716189|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.8938|TWO_SIDED|95.0|0.45|1.97||Log Rank Test stratified by randomization strata.|Log Rank||Cox proportional hazard model stratified by randomization strata, with treatment group as the fixed effect. Firth's adjustment was applied if no event was observed in a treatment group.|||1.97|0.45|0.8938
70929824|NCT05423730|141357132|SUPERIORITY||Mean Difference (Final Values)|12.57|||||TWO_SIDED|95.0|-0.77|27.69|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||27.69|-0.77|
71014642|NCT03557775|141536508|SUPERIORITY|||||||0.708||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.708
71014643|NCT03557775|141536509|SUPERIORITY|||||||0.988||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.988
71014644|NCT03414658|141536552|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.025|TWO_SIDED|80.0|0.35|0.81|||Log Rank|||||0.81|0.35|0.025
71014645|NCT03414658|141536552|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.32|TWO_SIDED|80.0|0.8|1.64|||Log Rank|||||1.64|0.8|0.32
71014646|NCT04957979|141536593|SUPERIORITY||Mean Difference (Net)|-1.6||||0.19|TWO_SIDED|95.0|-4.1|0.1||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Negative value represents smaller change in Medical/Social clinics as compared to Medical/Nursing.|Null hypothesis: Average change in composite care quality outcome is not different between patients receiving care in Medical/Nursing Model clinics and those receiving care in Medical/Social Model clinics.||0.1|-4.1|0.19
71104461|NCT04752566|141716190|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8987|TWO_SIDED|95.0|0.27|3.17|||Regression, Logistic|||Week 8||3.17|0.27|0.8987
71104462|NCT04752566|141716190|SUPERIORITY||Odds Ratio (OR)|0.6||||0.4083|TWO_SIDED|95.0|0.18|2.02|||Regression, Logistic|||Week 24||2.02|0.18|0.4083
71014647|NCT04957979|141536593|SUPERIORITY||Mean Difference (Net)|-3.3||||0.005|TWO_SIDED|95.0|-5.6|-1.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Negative value represents smaller change in Medical/Social clinics as compared to Medical/Nursing.|Null hypothesis: Average change in composite care quality outcome is not different between patients receiving care in Medical/Nursing Model clinics and those receiving care in Medical/Social Model clinics.||-1.0|-5.6|0.005
71014648|NCT04957979|141536594|SUPERIORITY||Incidence Rate Ratio|1.28||||0.02|TWO_SIDED|95.0|1.04|1.58||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher rates post-care coordination in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Poisson link function. Pre-care coordination measures were included as an independent variable when modeling post-measures to capture change related to care coordination initiation.||1.58|1.04|0.02
71014649|NCT04957979|141536594|SUPERIORITY||Incidence Rate Ratio|1.09||||0.45|TWO_SIDED|95.0|0.868|1.38||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher rates post-care coordination in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Poisson link function. Pre-care coordination measures were included as an independent variable when modeling post-measures to capture change related to care coordination initiation.||1.38|0.868|0.45
71014650|NCT04957979|141536595|SUPERIORITY||Incidence Rate Ratio|1.35||||0.01|TWO_SIDED|95.0|1.08|1.69||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher rates post-care coordination in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Poisson link function. Pre-care coordination measures were included as an independent variable when modeling post-measures to capture change related to care coordination initiation.||1.69|1.08|0.01
71014651|NCT04957979|141536595|SUPERIORITY||Incidence Rate Ratio|1.33||||0.08|TWO_SIDED|95.0|0.969|1.81||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher rates post-care coordination in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Poisson link function. Pre-care coordination measures were included as an independent variable when modeling post-measures to capture change related to care coordination initiation.||1.81|0.969|0.08
71014652|NCT04957979|141536596|SUPERIORITY||Odds Ratio (OR)|0.64||||0.0001|TWO_SIDED|95.0|0.51|0.81||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher likelihood of positive rating in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Binomial link function.||0.81|0.51|0.0001
71014653|NCT04957979|141536596|SUPERIORITY||Odds Ratio (OR)|1.2||||0.32|TWO_SIDED|95.0|0.84|1.72||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher likelihood of positive rating in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Binomial link function.||1.72|0.84|0.32
71014654|NCT04957979|141536597|SUPERIORITY||Odds Ratio (OR)|0.85||||0.14|TWO_SIDED|95.0|0.69|1.05||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher likelihood of positive rating in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Binomial link function.||1.05|0.69|0.14
71014655|NCT04957979|141536597|SUPERIORITY||Odds Ratio (OR)|0.74||||0.12|TWO_SIDED|95.0|0.51|1.08||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher likelihood of positive rating in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Binomial link function.||1.08|0.51|0.12
71049096|NCT02944383|141606142|SUPERIORITY|||||||0.4346||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.4346
71049097|NCT02944383|141606143|SUPERIORITY|||||||0.5411||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.5411
71104463|NCT04752566|141716191|SUPERIORITY||Odds Ratio (OR)|0.8||||0.6739|TWO_SIDED|95.0|0.24|2.54|||Regression, Logistic|||||2.54|0.24|0.6739
70929825|NCT05423730|141357133|SUPERIORITY||Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-21.92|21.24|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||21.24|-21.92|
71104464|NCT01728246|141716215|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71104465|NCT01728246|141716216|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71104466|NCT01728246|141716218|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71104467|NCT01983111|141716221|NON_INFERIORITY_OR_EQUIVALENCE|In the PP set, for a non-inferiority test of the reduction in the pain intensity score from Visit 1 (Baseline) to Week 6 of treatment, the lower limit of the 97.5% onesided confidence interval was compared to a clinical non-inferiority margin, -1.5.|Mean Difference (Final Values)|-0.43|STANDARD_DEVIATION|1.79||0.2658|TWO_SIDED|97.5|-6.0|3.0|||t-test, 2 sided|||In the Per protocol set||3|-6|0.2658
71014656|NCT04957979|141536598|SUPERIORITY||Odds Ratio (OR)|1.086||||0.914|TWO_SIDED|95.0|0.243|4.861||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||4.861|0.243|0.914
71014657|NCT04957979|141536598|SUPERIORITY||Odds Ratio (OR)|1.009||||0.987|TWO_SIDED|95.0|0.327|3.114||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||3.114|0.327|0.987
71014658|NCT04957979|141536599|SUPERIORITY||Odds Ratio (OR)|1.257||||0.204|TWO_SIDED|95.0|0.883|1.79||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.79|0.883|0.204
71014659|NCT04957979|141536599|SUPERIORITY||Odds Ratio (OR)|0.399||||0.04|TWO_SIDED|95.0|0.166|0.958|||Mixed Models Analysis|||||0.958|0.166|0.04
71014660|NCT04957979|141536600|SUPERIORITY||Odds Ratio (OR)|1.257||||0.302|TWO_SIDED|95.0|0.814|1.939||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.939|0.814|0.302
71014661|NCT04957979|141536600|SUPERIORITY||Odds Ratio (OR)|0.84||||0.192|TWO_SIDED|95.0|0.647|1.092||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.092|0.647|0.192
71049098|NCT02944383|141606143|SUPERIORITY|||||||0.2574||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2574
71049099|NCT02944383|141606143|SUPERIORITY||Median Difference (Net)|3.11||||0.5411|TWO_SIDED|95.0|-9.59|14.86||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||14.86|-9.59|0.5411
71014662|NCT04957979|141536601|SUPERIORITY||Odds Ratio (OR)|0.438||||0.318|TWO_SIDED|95.0|0.086|2.22||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||2.22|0.086|0.318
71014663|NCT04957979|141536601|SUPERIORITY||Odds Ratio (OR)|1.793||||0.421|TWO_SIDED|95.0|0.433|7.426||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||7.426|0.433|0.421
71014664|NCT04957979|141536602|SUPERIORITY||Odds Ratio (OR)|0.906||||0.632|TWO_SIDED|95.0|0.606|1.356||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.356|0.606|0.632
71014665|NCT04957979|141536602|SUPERIORITY||Odds Ratio (OR)|0.845||||0.492|TWO_SIDED|95.0|0.523|1.366||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.366|0.523|0.492
71049100|NCT02944383|141606143|SUPERIORITY||Median Difference (Net)|-7.31||||0.2574|TWO_SIDED|95.0|-19.3|5.76||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||5.76|-19.30|0.2574
71049101|NCT02944383|141606144|SUPERIORITY|||||||0.3998||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3998
71049102|NCT02944383|141606144|SUPERIORITY|||||||0.3659||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3659
71014666|NCT04957979|141536603|SUPERIORITY||Odds Ratio (OR)|0.856||||0.405|TWO_SIDED|95.0|0.594|1.234||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.234|0.594|0.405
71104468|NCT04380142|141716285|SUPERIORITY||Least Squares (LS) Mean of Difference|1.75|STANDARD_ERROR_OF_MEAN|0.65||0.0083|TWO_SIDED|95.0|0.46|3.05||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|mixed model repeated measures|||||3.05|0.46|0.0083
71014667|NCT04957979|141536603|SUPERIORITY||Odds Ratio (OR)|0.559||||0.004|TWO_SIDED|95.0|0.374|0.834|||Mixed Models Analysis|||||0.834|0.374|0.004
71049103|NCT02944383|141606144|SUPERIORITY|||||||0.3998||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.3998
71049104|NCT02944383|141606144|SUPERIORITY|||||||0.3659||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.3659
71049105|NCT02944383|141606145|SUPERIORITY|||||||0.8823||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.8823
71049106|NCT02944383|141606145|SUPERIORITY|||||||0.3788||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.3788
71049107|NCT02944383|141606145|SUPERIORITY|||||||0.1091||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1091
71049108|NCT02944383|141606145|SUPERIORITY|||||||0.6867||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.6867
71049109|NCT02944383|141606145|SUPERIORITY||Median Difference (Net)|9.07||||0.3156|TWO_SIDED|95.0|-12.22|36.34||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||36.34|-12.22|0.3156
71049110|NCT02944383|141606145|SUPERIORITY||Median Difference (Net)|-0.3||||0.9734|TWO_SIDED|95.0|-24.58|25.43||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||25.43|-24.58|0.9734
71049111|NCT02944383|141606146|SUPERIORITY|||||||0.9772||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.9772
71049112|NCT02944383|141606146|SUPERIORITY|||||||0.5213||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.5213
71049113|NCT02944383|141606146|SUPERIORITY|||||||0.1582||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1582
71049114|NCT02944383|141606146|SUPERIORITY|||||||0.4588||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4588
71104469|NCT04380142|141716286|SUPERIORITY||LS Mean of Difference|-1.79|STANDARD_ERROR_OF_MEAN|0.63||0.0054|TWO_SIDED|95.0|-3.03|-0.54||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|mixed model repeated measures|||||-0.54|-3.03|0.0054
70850602|NCT02712047|141189438|OTHER||Mean Difference (Net)|31.56|||||TWO_SIDED|95.0|9.38|53.73|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 2, PM|||53.73|9.38|
70929826|NCT05363163|141357139|OTHER|If the mean volume variation was higher than 0 and the p-value of the statistical test lower than 0.05, the H0 hypothesis was rejected, and the primary endpoint demonstrated.|||||<|0.0001||||||p-value of the statistical test lower than 0.05|t-test, 2 sided|||||||<0.0001
71014668|NCT04957979|141536604|SUPERIORITY||Odds Ratio (OR)|0.151||||0.071|TWO_SIDED|95.0|0.02|1.173||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.173|0.02|0.071
71104470|NCT04380142|141716287|SUPERIORITY||LS Mean of Difference|-1.58|STANDARD_ERROR_OF_MEAN|1.05||0.1318|TWO_SIDED|95.0|-3.65|0.48||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|mixed model repeated measures|||||0.48|-3.65|0.1318
71049115|NCT02944383|141606146|SUPERIORITY|||||||0.4264||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.4264
71049116|NCT02944383|141606146|SUPERIORITY|||||||0.8107||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.8107
71049117|NCT02944383|141606147|SUPERIORITY||Odds Ratio (OR)|5.38||||0.0093|TWO_SIDED|95.0|1.51|19.08||Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.|Regression, Logistic||The OR is an estimate of the odds of achieving a TG value \< 500 mg/dL associated with the corresponding Gemcabene group relative to the placebo group at a given visit.|Week 10||19.08|1.51|0.0093
71049118|NCT02944383|141606147|SUPERIORITY||Odds Ratio (OR)|2.57||||0.107|TWO_SIDED|95.0|0.82|8.07||Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.|Regression, Logistic||The OR is an estimate of the odds of achieving a TG value \< 500 mg/dL associated with the corresponding Gemcabene group relative to the placebo group at a given visit.|Week 10||8.07|0.82|0.1070
71049119|NCT02944383|141606147|SUPERIORITY||Odds Ratio (OR)|2.57||||0.0865|TWO_SIDED|95.0|0.87|7.53||Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.|Regression, Logistic|||Week 12||7.53|0.87|0.0865
70929827|NCT00670241|141357146|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.42|||<|0.001|TWO_SIDED|95.0|2.05|5.7|||Cochran-Mantel-Haenszel|||||5.70|2.05|< 0.001
71014669|NCT04957979|141536604|SUPERIORITY||Mean Difference (Net)|0.023||||0.003|TWO_SIDED|95.0|0.002|0.268||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||0.268|0.002|0.003
71104471|NCT04380142|141716288|SUPERIORITY||Odds Ratio (OR)|0.12|STANDARD_ERROR_OF_MEAN|0.49|<=|0.001|TWO_SIDED|95.0|0.04|0.31||The generalized linear mixed model: status = treatment country visit baseline treatment\*visit. The unstructured variance-covariance structure is used.|generalized linear mixed model|||||0.31|0.04|<=0.001
71014670|NCT04957979|141536605|SUPERIORITY||Odds Ratio (OR)|0.884||||0.557|TWO_SIDED|95.0|0.587|1.333||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.333|0.587|0.557
71014671|NCT04957979|141536605|SUPERIORITY||Mean Difference (Net)|0.624||||0.069|TWO_SIDED|95.0|0.376|1.037||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.037|0.376|0.069
71014672|NCT04957979|141536606|SUPERIORITY||Odds Ratio (OR)|0.539||||0.256|TWO_SIDED|95.0|0.185|1.565||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.565|0.185|0.256
71014673|NCT04957979|141536606|SUPERIORITY||Odds Ratio (OR)|1.117||||0.866|TWO_SIDED|95.0|0.308|4.047||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||4.047|0.308|0.866
71049120|NCT02944383|141606147|SUPERIORITY||Odds Ratio (OR)|1.57||||0.399|TWO_SIDED|95.0|0.55|4.48||Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.|Regression, Logistic||The OR is an estimate of the odds of achieving a TG value \< 500 mg/dL associated with the corresponding Gemcabene group relative to the placebo group at a given visit.|Week 12||4.48|0.55|0.3990
71104472|NCT04380142|141716289|SUPERIORITY||Odds Ratio (OR)|1.81|STANDARD_ERROR_OF_MEAN|0.68||0.0091|TWO_SIDED|95.0|0.46|3.16|||generalized linear mixed model|||||3.16|0.46|0.0091
70929828|NCT00670241|141357147|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.51|||<|0.001|TWO_SIDED|98.33|1.46|8.4|||Cochran-Mantel-Haenszel|||||8.40|1.46|<0.001
71014674|NCT04957979|141536607|SUPERIORITY||Odds Ratio (OR)|0.797||||0.641|TWO_SIDED|95.0|0.307|2.069||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||2.069|0.307|0.641
71104473|NCT04380142|141716290|SUPERIORITY||LS Mean of Difference|-5.4|STANDARD_ERROR_OF_MEAN|1.32|<=|0.001|TWO_SIDED|95.0|-8.03|-2.78||ANCOVA model including effects for treatment, country, and baseline.|ANCOVA|||||-2.78|-8.03|<=0.001
70929829|NCT00670241|141357148|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.7|||<|0.001|TWO_SIDED|98.33|-22.6|-6.9|||ANOVA|||||-6.90|-22.6|<0.001
70929830|NCT05552508|141357168|OTHER|||||||0.0327|||||||t-test, 2 sided|||All participants||||0.0327
70929831|NCT05552508|141357168|OTHER|||||||0.0359|||||||t-test, 2 sided|||Participants with \>=4 mucus plugs||||0.0359
71014675|NCT04957979|141536607|SUPERIORITY||Odds Ratio (OR)|0.569||||0.32|TWO_SIDED|95.0|0.187|1.729||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.729|0.187|0.32
71104474|NCT04380142|141716291|SUPERIORITY||Least Squares (LS) Mean of Difference|-4.1|STANDARD_ERROR_OF_MEAN|2.04||0.047|TWO_SIDED|95.0|-8.14|-0.05||ANCOVA model including effects for treatment, country, and baseline.|ANCOVA|||||-0.05|-8.14|0.0470
71104475|NCT04380142|141716292|SUPERIORITY||LS Mean of Difference|0.049|STANDARD_ERROR_OF_MEAN|0.025||0.0566|TWO_SIDED|95.0|-0.001|0.1||ANCOVA model including effects for treatment, country, and baseline.|ANCOVA|||||0.100|-0.001|0.0566
70850603|NCT02712047|141189438|OTHER||Mean Difference (Net)|22.86|||||TWO_SIDED|95.0|0.68|45.03|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 3, AM|||45.03|0.68|
71014676|NCT04957979|141536608|SUPERIORITY||Risk Difference (RD)|9.3|||<|0.001|TWO_SIDED|95.0|5.6|13.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||13|5.6|<.001
71014677|NCT04957979|141536608|SUPERIORITY||Risk Difference (RD)|11.0||||0.002|TWO_SIDED|95.0|4.2|18.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher proportion of responders in Medical/Nursing clinics as compared to Medical/Social.|||18|4.2|0.002
71014678|NCT04957979|141536609|SUPERIORITY||Risk Difference (RD)|6.0||||0.023|TWO_SIDED|95.0|0.86|11.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||11.0|0.86|0.023
71014679|NCT04957979|141536609|SUPERIORITY||Risk Difference (RD)|-3.7||||0.5|TWO_SIDED|95.0|-14.0|7.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher proportion of responders in Medical/Nursing clinics as compared to Medical/Social.|||7.0|-14.0|0.5
71014680|NCT04957979|141536610|SUPERIORITY||Mean Difference (Net)|0.13|||<|0.001|TWO_SIDED|95.0|0.06|0.19||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|t-test, 2 sided||Positive values reflect higher/better scores of responders in Medical/Nursing clinics as compared to Medical/Social.|||0.19|0.06|<0.001
71014681|NCT04957979|141536610|SUPERIORITY||Mean Difference (Net)|0.19|||<|0.001|TWO_SIDED|95.0|0.06|0.32||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|t-test, 2 sided||Positive values reflect higher/better scores of responders in Medical/Nursing clinics as compared to Medical/Social.|||0.32|0.06|<0.001
71014682|NCT04957979|141536611|SUPERIORITY||Mean Difference (Net)|-0.11|||<|0.001|TWO_SIDED|95.0|-0.16|-0.06|||t-test, 2 sided|No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Negative values reflect lower/better scores of responders in Medical/Nursing clinics as compared to Medical/Social.|||-0.06|-0.16|<0.001
71014683|NCT04957979|141536611|SUPERIORITY||Mean Difference (Net)|-0.11||||0.006|TWO_SIDED|95.0|-0.2|-0.03|||t-test, 2 sided||Negative values reflect lower/better scores of responders in Medical/Nursing clinics as compared to Medical/Social.|||-0.03|-0.2|0.006
71014684|NCT04957979|141536612|SUPERIORITY||Risk Difference (RD)|-2.4||||0.059|TWO_SIDED|95.0|-4.9|0.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared|||||0.00|-4.9|0.059
71014685|NCT04957979|141536612|SUPERIORITY||Risk Difference (RD)|-5.7||||0.014|TWO_SIDED|95.0|-10.0|-1.3||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-1.3|-10.0|0.014
71014686|NCT04957979|141536613|SUPERIORITY||Risk Difference (RD)|11.0|||<|0.001|TWO_SIDED|95.0|6.8|15.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared|||||15.0|6.8|<0.001
71014687|NCT04957979|141536613|SUPERIORITY||Risk Difference (RD)|12.0||||0.001|TWO_SIDED|95.0|4.7|20.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||20.0|4.7|0.001
71014688|NCT04957979|141536614|SUPERIORITY||Mean Difference (Net)|-7.6|||<|0.001|TWO_SIDED|95.0|-10.0|-5.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|t-test, 2 sided||Negative values reflect lower/better scores of responders in Medical/Nursing clinics as compared to Medical/Social.|||-5|-10|<.001
71014689|NCT04957979|141536614|SUPERIORITY||Mean Difference (Net)|-6.0||||0.007|TWO_SIDED|95.0|-10.0|-2.0|||t-test, 2 sided||Negative values reflect lower/better scores of responders in Medical/Nursing clinics as compared to Medical/Social.|||-2|-10|0.007
71014690|NCT04957979|141536615|SUPERIORITY||Risk Difference (RD)|-2.5||||0.046|TWO_SIDED|95.0|-4.8|-0.14||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-0.14|-4.8|0.046
71014691|NCT04957979|141536615|SUPERIORITY||Risk Difference (RD)|-4.5||||0.033|TWO_SIDED|95.0|-8.4|-0.52||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-0.52|-8.4|0.033
71104476|NCT04380142|141716293|SUPERIORITY||LS Mean of Difference|1.72|STANDARD_ERROR_OF_MEAN|0.72||0.0184|TWO_SIDED|95.0|0.3|3.15||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|Repeated measures model|||||3.15|0.30|0.0184
71104477|NCT04380142|141716294|SUPERIORITY||LS Mean of Difference|0.18|STANDARD_ERROR_OF_MEAN|0.69||0.7989|TWO_SIDED|95.0|-1.2|1.55||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|Repeated measures model|||||1.55|-1.20|0.7989
71014692|NCT04957979|141536616|SUPERIORITY||Risk Difference (RD)|-10.0|||<|0.001|TWO_SIDED|95.0|-13.0|-6.8||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-6.8|-13.0|<0.001
71014693|NCT04957979|141536616|SUPERIORITY||Risk Difference (RD)|-11.0|||<|0.001|TWO_SIDED|95.0|-17.0|-5.6||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-5.6|-17.0|<0.001
71014694|NCT04957979|141536617|SUPERIORITY||Risk Difference (RD)|-7.2|||<|0.001|TWO_SIDED|95.0|-10.0|-4.1||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-4.1|-10.0|<0.001
71014695|NCT04957979|141536617|SUPERIORITY||Risk Difference (RD)|-8.2||||0.002|TWO_SIDED|95.0|-13.0|-3.2||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social|||-3.2|-13.0|0.002
71014696|NCT04957979|141536618|SUPERIORITY||Risk Difference (RD)|-3.4||||0.002|TWO_SIDED|95.0|-5.5|-1.4||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-1.4|-5.5|0.002
71014697|NCT04957979|141536618|SUPERIORITY||Risk Difference (RD)|-2.4||||0.3|TWO_SIDED|95.0|-6.1|1.4||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||1.4|-6.1|0.3
71014698|NCT02255422|141536619|SUPERIORITY||LS mean difference (net)|-0.015|STANDARD_ERROR_OF_MEAN|0.0446||0.7321|TWO_SIDED|95.0|-0.1051|0.0743||P-Value relates to difference in change in peak work from baseline relative to placebo for all doses pooled. Statistical significance was defined as p\<0.05|Mixed Models Analysis|Null hypothesis: wk 12 mean change from baseline (\[μ RTA 408\] - \[μ Placebo\]) in peak work = 0 w/kg. Positive change from baseline suggests improvement||Primary Objective: To evaluate the change in peak work during maximal exercise testing||0.0743|-0.1051|0.7321
71014699|NCT02255422|141536620|SUPERIORITY||LS mean difference (net)|-33.448|STANDARD_ERROR_OF_MEAN|11.6473||0.006|TWO_SIDED|95.0|-56.855|-10.042||P-value comparison is for difference in change in six minute walk distance from baseline within each dosage group relative to placebo. Statistical significance defined as p\<0.05.|Mixed Models Analysis|The change from baseline in 6MWT was analyzed using the same MMRM model used for the primary efficacy endpoint. Analysis visits 0, 4, 8 and 12 used.||Secondary Objective: To evaluate the change in 6-minute walk test (6MWT) distance at Week 4||-10.042|-56.855|0.0060
71014700|NCT02255422|141536620|SUPERIORITY||LS mean difference (net)|-3.963|STANDARD_ERROR_OF_MEAN|11.53||0.7325|TWO_SIDED|95.0|-27.133|19.207||Statistical significance was defined as p\<0.05. The p-value comparison is for the difference in change in 6MWD from baseline within each dosage group relative to placebo.|Mixed Models Analysis|The change from baseline in 6MWT was analyzed using the same MMRM model used for the primary efficacy endpoint. Analysis visits 0, 4, 8 and 12 used.||Secondary Objective: To evaluate the change in 6-minute walk test (6MWT) distance at Week 8||19.207|-27.133|0.7325
71049121|NCT02944383|141606147|SUPERIORITY||Odds Ratio (OR)|2.75||||0.0772|TWO_SIDED|95.0|0.9|8.42||Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.|Regression, Logistic||The OR is an estimate of the odds of achieving a TG value \< 500 mg/dL associated with the corresponding Gemcabene group relative to the placebo group at a given visit.|EOS (average of week 10 and 12)||8.42|0.90|0.0772
71014701|NCT02255422|141536620|SUPERIORITY||LS mean difference (net)|-18.594|STANDARD_ERROR_OF_MEAN|15.0004||0.221|TWO_SIDED|95.0|-48.739|11.55||Statistical significance was defined as p\<0.05. The p-value comparison is for the difference in change in 6MWD from baseline within each dosage group relative to placebo.|Mixed Models Analysis|The change from baseline in 6MWT was analyzed using the same MMRM model used for the primary efficacy endpoint. Analysis visits 0, 4, 8 and 12 used.||Secondary Objective: To evaluate the change in 6-minute walk test (6MWT) distance at Week 12||11.550|-48.739|0.2210
71014702|NCT04411641|141536621|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|Hazard Ratio (HR)|0.693||||0.0026|TWO_SIDED|95.0|0.546|0.88||Threshold for significance at 2-sided 0.05 level.|Regression, Cox|||Derived using Cox proportional-hazards model with robust variance estimation.Covariates were treatment group,age at screening (\>40,\<=40 years),geographic region (United States \[US\], non-US),baseline EDSS score \& baseline gadolinium (Gd)-enhancing T1 lesions (presence, absence).In this analysis, for participants who completed study with 3-month confirmation and continued to meet disability progression criteria throughout EOS, their 6-month CDP status was imputed via multiple imputation method.||0.880|0.546|0.0026
71014703|NCT04411641|141536622|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|Hazard Ratio (HR)|0.757||||0.0134|TWO_SIDED|95.0|0.607|0.944||Threshold for significance at 2-sided 0.05 level.|Regression, Cox|||Derived using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, age at screening (\>40, \<=40 years), geographic region (US, non-US), baseline EDSS score and baseline Gd-enhancing T1 lesions (presence, absence).||0.944|0.607|0.0134
71014704|NCT04411641|141536623|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|Relative Risk|0.622||||0.011|TWO_SIDED|95.0|0.432|0.897||Threshold for significance at 2-sided 0.05 level.|Chi-squared|||Derived using negative binomial model with the number of new and/or enlarging T2-hyperintense lesions between randomization date and EOS date as the response variable, treatment group, age at screening (\>40, \<=40 years), geographic region (US, non-US), baseline EDSS score, and baseline number of T2 lesions as covariates, and log transformed observation duration as the offset variable.||0.897|0.432|0.0110
71049122|NCT02944383|141606147|SUPERIORITY||Odds Ratio (OR)|1.54||||0.4315|TWO_SIDED|95.0|0.53|4.48||Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.|Regression, Logistic||The OR is an estimate of the odds of achieving a TG value \< 500 mg/dL associated with the corresponding Gemcabene group relative to the placebo group at a given visit.|EOS (average of week 10 and 12)||4.48|0.53|0.4315
71049123|NCT00364949|141606148|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||t-test, 2 sided|||||||0.049
71049124|NCT00364949|141606149|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||t-test, 2 sided|||||||0.042
71049125|NCT00364949|141606150|SUPERIORITY_OR_OTHER|||||||0.156||95.0|||||t-test, 2 sided|||||||0.156
71049126|NCT00364949|141606151|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||t-test, 2 sided|||||||0.770
71049127|NCT00364949|141606152|SUPERIORITY_OR_OTHER|||||||0.325||95.0|||||t-test, 2 sided|||||||0.325
71049128|NCT00807248|141606159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.96||0.6405|TWO_SIDED|95.0|-2.34|1.44|||ANCOVA|||||1.44|-2.34|0.6405
71049129|NCT00807248|141606159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.96||0.6227|TWO_SIDED|95.0|-1.41|2.35|||ANCOVA|||||2.35|-1.41|0.6227
71049130|NCT00807248|141606160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.55|STANDARD_ERROR_OF_MEAN|1.24|<|0.0001|TWO_SIDED|95.0|-7.98|-3.11|||ANCOVA|||||-3.11|-7.98|<0.0001
71049131|NCT00807248|141606160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.09|STANDARD_ERROR_OF_MEAN|1.24|<|0.0001|TWO_SIDED|95.0|-7.53|-2.66|||ANCOVA|||||-2.66|-7.53|<0.0001
71049132|NCT00807248|141606160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0|STANDARD_ERROR_OF_MEAN|1.24|<|0.0001|TWO_SIDED|95.0|-8.43|-3.56|||ANCOVA|||||-3.56|-8.43|<0.0001
71049133|NCT00807248|141606161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.98|STANDARD_ERROR_OF_MEAN|1.09|<|0.0001|TWO_SIDED|95.0|-7.13|-2.84|||ANCOVA|||||-2.84|-7.13|<0.0001
71049134|NCT00807248|141606161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.46|STANDARD_ERROR_OF_MEAN|1.09|<|0.0001|TWO_SIDED|95.0|-6.6|-2.32|||ANCOVA|||||-2.32|-6.60|<0.0001
71049135|NCT00807248|141606161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.27|STANDARD_ERROR_OF_MEAN|1.09|<|0.0001|TWO_SIDED|95.0|-7.41|-3.13|||ANCOVA|||||-3.13|-7.41|<0.0001
71049136|NCT00807248|141606162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.09|STANDARD_ERROR_OF_MEAN|0.77|<|0.0001|TWO_SIDED|95.0|-4.59|-1.58|||ANCOVA|||||-1.58|-4.59|<0.0001
71049137|NCT00807248|141606162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.64|STANDARD_ERROR_OF_MEAN|0.77||0.0006|TWO_SIDED|95.0|-4.15|-1.14|||ANCOVA|||||-1.14|-4.15|0.0006
71049138|NCT00807248|141606162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.61|STANDARD_ERROR_OF_MEAN|0.77|<|0.0001|TWO_SIDED|95.0|-5.13|-2.1|||ANCOVA|||||-2.10|-5.13|<0.0001
71049139|NCT00807248|141606163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-1.85|-0.64|||ANCOVA|||||-0.64|-1.85|<0.0001
71049140|NCT00807248|141606163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11|STANDARD_ERROR_OF_MEAN|0.31||0.0004|TWO_SIDED|95.0|-1.72|-0.5|||ANCOVA|||||-0.50|-1.72|0.0004
71049141|NCT00807248|141606163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-1.87|-0.65|||ANCOVA|||||-0.65|-1.87|<0.0001
71049142|NCT00807248|141606164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|0.32||0.0007|TWO_SIDED|95.0|-1.72|-0.46|||ANCOVA|||||-0.46|-1.72|0.0007
71049143|NCT00807248|141606164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.33||0.0013|TWO_SIDED|95.0|-1.69|-0.41|||ANCOVA|||||-0.41|-1.69|0.0013
71049144|NCT00807248|141606164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-1.92|-0.66|||ANCOVA|||||-0.66|-1.92|<0.0001
71049145|NCT00807248|141606165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.31||0.0002|TWO_SIDED|95.0|-1.82|-0.58|||ANCOVA|||||-0.58|-1.82|0.0002
71049146|NCT00807248|141606165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.32||0.0006|TWO_SIDED|95.0|-1.72|-0.48|||ANCOVA|||||-0.48|-1.72|0.0006
71049147|NCT00807248|141606165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-2.0|-0.76|||ANCOVA|||||-0.76|-2.00|<0.0001
71049148|NCT00807248|141606166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.89|-0.34|||ANCOVA|||||-0.34|-0.89|<0.0001
71049149|NCT00807248|141606166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.14||0.0001|TWO_SIDED|95.0|-0.82|-0.26|||ANCOVA|||||-0.26|-0.82|0.0001
71049150|NCT00807248|141606166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.99|-0.44|||ANCOVA|||||-0.44|-0.99|<0.0001
71049151|NCT00807248|141606167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.02|-0.5|||ANCOVA|||||-0.50|-1.02|<0.0001
71049152|NCT00807248|141606167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.88|-0.36|||ANCOVA|||||-0.36|-0.88|<0.0001
71049153|NCT00807248|141606167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.97|-0.45|||ANCOVA|||||-0.45|-0.97|<0.0001
71049154|NCT02504671|141606183|OTHER||Odds Ratio (OR)|2.12||||0.547|TWO_SIDED|95.0|0.18|24.52|||Regression, Logistic||95% Confidence Intervals (CI) were constructed using asymptotic Wald confidence limits without correction.|||24.52|0.18|0.547
71049155|NCT02504671|141606183|OTHER||Odds Ratio (OR)|7.11||||0.077|TWO_SIDED|95.0|0.81|62.44|||Regression, Logistic||95% CI were constructed using asymptotic Wald confidence limits without correction.|||62.44|0.81|0.077
71049156|NCT02504671|141606183|OTHER||Odds Ratio (OR)|8.39||||0.053|TWO_SIDED|95.0|0.98|72.14|||Regression, Logistic||95% CI were constructed using asymptotic Wald confidence limits without correction.|||72.14|0.98|0.053
71049157|NCT02504671|141606183|OTHER||Odds Ratio (OR)|5.69||||0.122|TWO_SIDED|95.0|0.63|51.4|||Regression, Logistic||95% CI were constructed using asymptotic Wald confidence limits without correction.|||51.40|0.63|0.122
71049158|NCT02504671|141606183|OTHER||Odds Ratio (OR)|5.4||||0.134|TWO_SIDED|95.0|0.6|48.83|||Regression, Logistic||95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.83|0.60|0.134
71014705|NCT04411641|141536624|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|Hazard Ratio (HR)|0.972||||0.8428|TWO_SIDED|95.0|0.735|1.286||Threshold for significance at 2-sided 0.05 level.|Regression, Cox|||Derived using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, age at screening (\>40, \<=40 years), geographic region (US, non-US), baseline EDSS score and baseline Gd-enhancing T1 lesions (presence, absence).||1.286|0.735|0.8428
71014706|NCT04411641|141536625|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|Hazard Ratio (HR)|0.767||||0.004|TWO_SIDED|95.0|0.64|0.919|||Regression, Cox|||Derived using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, age at screening (\>40, \<=40 years), geographic region (US, non-US), baseline EDSS score and baseline Gd-enhancing T1 lesions (presence, absence).||0.919|0.640|0.0040
71014707|NCT04411641|141536626|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|Hazard Ratio (HR)|1.882||||0.0206|TWO_SIDED|95.0|1.102|3.214|||Regression, Cox|||Derived using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, age at screening (\>40, \<=40 years), geographic region (US, non-US), baseline EDSS score and baseline Gd-enhancing T1 lesions (presence, absence).||3.214|1.102|0.0206
71014708|NCT04411641|141536627|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|LS Mean Difference|0.082||||0.1646|TWO_SIDED|95.0|-0.034|0.197|||Mixed model repeated measures (MMRM)|||Covariates in the mixed-effect model with repeated measures were treatment group, age at screening (\>40, \<=40 years), geographic region (US, non-US), visit, treatment-by-visit interaction, cube root transformed Month 6 brain volume, and cube root transformed Month 6 brain volume-by-visit interaction.||0.197|-0.034|0.1646
71014709|NCT03810417|141536638|SUPERIORITY||||||>|0.05|||||||Regression, Linear|||||||>0.05
71014710|NCT03810417|141536638|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|||||||<0.05
71014711|NCT03222570|141536640|SUPERIORITY||Estimated mean difference|-0.88||||0.76|TWO_SIDED|95.0|-6.56|4.7|||Regression, Linear||Mean difference estimated from fitting a linear regression model adjusting for baseline value of the measure.|||4.7|-6.56|0.76
71014712|NCT03222570|141536641|SUPERIORITY||Estimated mean difference|-2.52||||0.32|TWO_SIDED|95.0|-7.42|2.3|||Regression, Linear||Mean difference estimated from fitting a linear regression model adjusting for baseline value of the measure.|||2.3|-7.42|0.32
71049159|NCT02504671|141606184|OTHER||Mean Difference (Net)|0.46||||0.905|TWO_SIDED|95.0|-7.13|8.05||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|Mixed Model Repeated Measures (MMRM)||CRP, Week 12|||8.05|-7.13|0.905
71049160|NCT02504671|141606184|OTHER||Mean Difference (Net)|-3.36||||0.387|TWO_SIDED|95.0|-11.0|4.28||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||CRP, Week 12|||4.28|-11.00|0.387
71049161|NCT02504671|141606184|OTHER||Mean Difference (Net)|-2.58||||0.495|TWO_SIDED|95.0|-10.04|4.87||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||CRP, Week 12|||4.87|-10.04|0.495
71049162|NCT02504671|141606184|OTHER||Mean Difference (Net)|-7.68||||0.14|TWO_SIDED|95.0|-17.92|2.55||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||PtGA, Week 12|||2.55|-17.92|0.140
71049163|NCT02504671|141606184|OTHER||Mean Difference (Net)|-13.68||||0.009|TWO_SIDED|95.0|-23.85|-3.52||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||PtGA, Week 12|||-3.52|-23.85|0.009
71049164|NCT02504671|141606184|OTHER||Mean Difference (Net)|-17.4|||<|0.001|TWO_SIDED|95.0|-27.44|-7.35||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||PtGA, Week 12|||-7.35|-27.44|<0.001
71014713|NCT05182840|141536670|OTHER||Mean Difference (Net)|-0.168||||0.0499|TWO_SIDED|95.0|-0.337|0.0|||MMRM||"Least Squares Mean of 3 mg BI 690517 - Least Squares Mean of Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.000|-0.337|0.0499
71014714|NCT05182840|141536670|OTHER||Mean Difference (Net)|-0.486|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.313|||MMRM||"Least Squares Mean of 10 mg BI 690517 - Least Squares Mean of Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.313|-0.660|<.0001
71014715|NCT05182840|141536670|OTHER||Mean Difference (Net)|-0.421|||<|0.0001|TWO_SIDED|95.0|-0.596|-0.246|||MMRM||"Least Squares Mean of 20 mg BI 690517 - Least Squares Mean of Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.246|-0.596|<.0001
70929832|NCT05552508|141357168|OTHER|||||||0.1088|||||||t-test, 2 sided|||Participants with \<4 mucus plugs||||0.1088
71014716|NCT05182840|141536670|OTHER|Null hypothesis: The dose-response curve is flat across the 3 BI 690517 doses and the placebo.||||||0||||||P-value was rounded to four decimal places.|MCPMod Emax model fit|Emax model fit assumption: 80% of the maximum effect is achieved at 10 mg.||"A flat vs. non-flat dose-response relationship across the 3 doses of BI 690517 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod).~MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient."||||0.0000
71049165|NCT02504671|141606184|OTHER||Mean Difference (Net)|-2.42||||0.118|TWO_SIDED|95.0|-5.45|0.62||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||SJC28, Week 12|||0.62|-5.45|0.118
70929833|NCT05552508|141357168|OTHER|||||||0.0391|||||||t-test, 2 sided|||Non-OCS-dependent participants||||0.0391
71014717|NCT05182840|141536670|OTHER|Null hypothesis: The dose-response curve is flat across the 3 BI 690517 doses and the placebo.||||||0||||||P-value was rounded to four decimal places.|MCPMod linear model fit|Linear model fit assumption: No assumption is needed.||"A flat vs. non-flat dose-response relationship across the 3 doses of BI 690517 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod).~MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient."||||0.0000
71014718|NCT05182840|141536670|OTHER|Null hypothesis: The dose-response curve is flat across the 3 BI 690517 doses and the placebo.||||||0.0003|||||||MCPMod exponential model fit|Exponential model fit assumption: 15% of the maximum effect is achieved at 10 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of BI 690517 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod). MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||||0.0003
71014719|NCT05182840|141536671|OTHER||Median Difference (Net)|-15.5|||||TWO_SIDED|95.0|-28.6|0.0|||||"Median of 3 mg BI 690517 - Median of Placebo to BI 690517."|||-0.0|-28.6|
71014720|NCT05182840|141536671|OTHER||Median Difference (Net)|-38.5|||||TWO_SIDED|95.0|-48.3|-26.8|||||"Median of 10 mg BI 690517 - Median of Placebo to BI 690517."|||-26.8|-48.3|
71014721|NCT05182840|141536671|OTHER||Median Difference (Net)|-34.3|||||TWO_SIDED|95.0|-44.9|-21.8|||||"Median of 20 mg BI 690517 - Median of Placebo to BI 690517."|||-21.8|-44.9|
71014722|NCT05182840|141536672|OTHER||Mean Difference (Net)|-0.227||||0.0867|TWO_SIDED|95.0|-0.488|0.033|||MMRM||"Least Squares Mean of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 - Least Squares Mean of Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||0.033|-0.488|0.0867
71014723|NCT05182840|141536672|OTHER||Mean Difference (Net)|-0.469||||0.0007|TWO_SIDED|95.0|-0.737|-0.201|||MMRM||"Least Squares Mean of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 - Least Squares Mean of Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.201|-0.737|0.0007
70929834|NCT05552508|141357169|OTHER|||||||0.0423|||||||t-test, 2 sided|||||||0.0423
71014724|NCT05182840|141536672|OTHER||Mean Difference (Net)|-0.429||||0.0027|TWO_SIDED|95.0|-0.707|-0.151|||MMRM||"Least Squares Mean of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 6905177 - Least Squares Mean of Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.151|-0.707|0.0027
71014725|NCT05182840|141536673|OTHER||Median Difference (Net)|-20.3|||||TWO_SIDED|95.0|-38.6|3.4|||||"Median of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 - median of Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|||3.4|-38.6|
71014726|NCT05182840|141536673|OTHER||Median Difference (Net)|-37.4|||||TWO_SIDED|95.0|-52.2|-18.2|||||"Median of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 - median of Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517"|||-18.2|-52.2|
71049166|NCT02504671|141606184|OTHER||Mean Difference (Net)|-3.17||||0.041|TWO_SIDED|95.0|-6.2|-0.14||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||SJC28, Week 12|||-0.14|-6.20|0.041
70929835|NCT05552508|141357170|OTHER|||||||0.9465|||||||t-test, 2 sided|||||||0.9465
70929836|NCT05552508|141357171|OTHER|||||||0.3455|||||||t-test, 2 sided|||||||0.3455
70929837|NCT05552508|141357172|OTHER|||||||0.2484|||||||t-test, 2 sided|||||||0.2484
70929838|NCT05552508|141357173|OTHER|||||||0.9405|||||||t-test, 2 sided|||||||0.9405
70929839|NCT05552508|141357174|OTHER|||||||0.6867|||||||t-test, 2 sided|||||||0.6867
70929840|NCT05552508|141357175|OTHER|||||||0.7554|||||||t-test, 2 sided|||||||0.7554
70929841|NCT06037668|141357205|SUPERIORITY|||||||0.1134||||||p-values are calculated by independent t-test|Independent t-test|||||||0.1134
70929842|NCT06037668|141357206|SUPERIORITY|||||||0.0031||||||p-values are calculated by independent t-test|Independent t-test|||||||0.003100
71014727|NCT05182840|141536673|OTHER||Median Difference (Net)|-34.9|||||TWO_SIDED|95.0|-50.7|-14.0|||||"Median of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 6905177 - median of Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|||-14.0|-50.7|
70929843|NCT06037668|141357207|SUPERIORITY|||||||0.0503||||||p-values are calculated by independent t-test|Independent t-test|||||||0.050300
71014728|NCT05182840|141536674|OTHER||Mean Difference (Net)|-0.098||||0.3737|TWO_SIDED|95.0|-0.316|0.119|||MMRM||"Least Squares Mean of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 - Least Squares Mean of Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||0.119|-0.316|0.3737
71014729|NCT05182840|141536674|OTHER||Mean Difference (Net)|-0.502|||<|0.0001|TWO_SIDED|95.0|-0.73|-0.275|||MMRM||"Least Squares Mean of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 - Least Squares Mean of Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.275|-0.730|<.0001
71014730|NCT05182840|141536674|OTHER||Mean Difference (Net)|-0.404||||0.0004|TWO_SIDED|95.0|-0.625|-0.184|||MMRM||"Least Squares Mean of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 - Least Squares Mean of Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.184|-0.625|0.0004
71014731|NCT05182840|141536675|OTHER||Median Difference (Net)|-9.4|||||TWO_SIDED|95.0|-27.1|12.7|||||"Median of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 - median of Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|||12.7|-27.1|
71014732|NCT05182840|141536675|OTHER||Median Difference (Net)|-39.5|||||TWO_SIDED|95.0|-51.8|-24.0|||||"Median of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 - median of Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|||-24.0|-51.8|
71014733|NCT05182840|141536675|OTHER||Median Difference (Net)|-33.2|||||TWO_SIDED|95.0|-46.5|-16.8|||||"Median of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 - median of Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|||-16.8|-46.5|
71014734|NCT05182840|141536676|OTHER||Odds Ratio (OR)|2.08||||0.0136|TWO_SIDED|95.0|1.16|3.72||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.72|1.16|0.0136
71049167|NCT02504671|141606184|OTHER||Mean Difference (Net)|-4.56||||0.003|TWO_SIDED|95.0|-6.0|0.05||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||SJC28, Week 12|||0.05|-6.00|0.003
71049168|NCT02504671|141606184|OTHER||Mean Difference (Net)|-2.3||||0.172|TWO_SIDED|95.0|-5.61|1.01||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||TC28, Week 12|||1.01|-5.61|0.172
71049169|NCT02504671|141606184|OTHER||Mean Difference (Net)|-3.92||||0.02|TWO_SIDED|95.0|-7.22|-0.62||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||TJC28, Week 12|||-0.62|-7.22|0.020
71049170|NCT02504671|141606184|OTHER||Mean Difference (Net)|-5.72|||<|0.001|TWO_SIDED|95.0|-8.98|-2.45||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||TJC28, Week 12|||-2.45|-8.98|<0.001
71014735|NCT05182840|141536676|OTHER||Odds Ratio (OR)|7.02||||0|TWO_SIDED|95.0|3.94|12.49||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||12.49|3.94|0.0000
71014736|NCT05182840|141536676|OTHER||Odds Ratio (OR)|5.48||||0|TWO_SIDED|95.0|3.09|9.71||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||9.71|3.09|0.0000
71014737|NCT05182840|141536677|OTHER||Odds Ratio (OR)|2.15||||0.0111|TWO_SIDED|95.0|1.19|3.88||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.88|1.19|0.0111
71049171|NCT02504671|141606184|OTHER||Mean Difference (Net)|-2.51||||0.518|TWO_SIDED|95.0|-10.13|5.12||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||CRP, Week 12|||5.12|-10.13|0.518
70850604|NCT02712047|141189438|OTHER||Mean Difference (Net)|36.94|||||TWO_SIDED|95.0|14.77|59.12|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 3, PM|||59.12|14.77|
70929844|NCT06037668|141357208|SUPERIORITY|||||||0.1178||||||p-values are calculated by independent t-test|Independent t-test|||||||0.1178
70929845|NCT06037668|141357209|SUPERIORITY|||||||0.1003||||||p-values are calculated by independent t-test|Independent t-test|||||||0.1003
71014738|NCT05182840|141536677|OTHER||Odds Ratio (OR)|6.33||||0|TWO_SIDED|95.0|3.49|11.49||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||11.49|3.49|0.0000
71014739|NCT05182840|141536677|OTHER||Odds Ratio (OR)|5.21||||0|TWO_SIDED|95.0|2.88|9.44||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||9.44|2.88|0.0000
71014740|NCT05182840|141536678|OTHER||Odds Ratio (OR)|1.8||||0.0348|TWO_SIDED|95.0|1.04|3.09||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.09|1.04|0.0348
71014741|NCT05182840|141536678|OTHER||Odds Ratio (OR)|4.12||||0|TWO_SIDED|95.0|2.4|7.08||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.08|2.40|0.0000
71014742|NCT05182840|141536678|OTHER||Odds Ratio (OR)|5.02||||0|TWO_SIDED|95.0|2.91|8.67||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.67|2.91|0.0000
71014743|NCT05182840|141536679|OTHER||Odds Ratio (OR)|2.15||||0.0111|TWO_SIDED|95.0|1.19|3.88||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.88|1.19|0.0111
71014744|NCT05182840|141536679|OTHER||Odds Ratio (OR)|6.33||||0|TWO_SIDED|95.0|3.49|11.49||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||11.49|3.49|0.0000
71014745|NCT05182840|141536679|OTHER||Odds Ratio (OR)|5.21||||0|TWO_SIDED|95.0|2.88|9.44||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||9.44|2.88|0.0000
71014746|NCT05182840|141536680|OTHER||Odds Ratio (OR)|2.44||||0.0419|TWO_SIDED|95.0|1.03|5.74||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||5.74|1.03|0.0419
71049172|NCT02504671|141606184|OTHER||Mean Difference (Net)|-2.0||||0.599|TWO_SIDED|95.0|-9.5|5.49||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||CRP, Week 12|||5.49|-9.50|0.599
71014747|NCT05182840|141536680|OTHER||Odds Ratio (OR)|6.09||||0|TWO_SIDED|95.0|2.64|14.08||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||14.08|2.64|0.0000
71014748|NCT05182840|141536680|OTHER||Odds Ratio (OR)|6.13||||0|TWO_SIDED|95.0|2.64|14.25||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||14.25|2.64|0.0000
70929846|NCT06037668|141357210|SUPERIORITY|||||||0.4832||||||p-values are calculated by independent t-test|Independent t-test|||||||0.4832
70929847|NCT01199133|141357292|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.01|||>|0.05||95.0|-0.41|0.43|||ANCOVA|||||0.43|-0.41|> 0.05
71014749|NCT05182840|141536681|OTHER||Odds Ratio (OR)|2.88||||0.0195|TWO_SIDED|95.0|1.19|7.02||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.02|1.19|0.0195
71014750|NCT05182840|141536681|OTHER||Odds Ratio (OR)|6.38||||0|TWO_SIDED|95.0|2.65|15.35||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||15.35|2.65|0.0000
71014751|NCT05182840|141536681|OTHER||Odds Ratio (OR)|6.39||||0.0001|TWO_SIDED|95.0|2.6|15.67||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||15.67|2.60|0.0001
71014752|NCT05182840|141536682|OTHER||Odds Ratio (OR)|2.03||||0.0767|TWO_SIDED|95.0|0.93|4.42||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.42|0.93|0.0767
71014753|NCT05182840|141536682|OTHER||Odds Ratio (OR)|4.11||||0.0003|TWO_SIDED|95.0|1.89|8.91||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.91|1.89|0.0003
71049173|NCT02504671|141606184|OTHER||Mean Difference (Net)|-12.63||||0.015|TWO_SIDED|95.0|-22.78|-2.48||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||PtGA, Week 12|||-2.48|-22.78|0.015
71049174|NCT02504671|141606184|OTHER||Mean Difference (Net)|-17.18|||<|0.001|TWO_SIDED|95.0|-27.27|-7.1||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||PtGA, Week 12|||-7.10|-27.27|<0.001
71049175|NCT02504671|141606184|OTHER||Mean Difference (Net)|-2.98||||0.054|TWO_SIDED|95.0|-6.0|0.05||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||SJC28, Week 12|||0.05|-6.00|0.054
71049176|NCT02504671|141606184|OTHER||Mean Difference (Net)|-6.04|||<|0.001|TWO_SIDED|95.0|-9.05|-3.02||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||SJC28, Week 12|||-3.02|-9.05|<0.001
71049177|NCT02504671|141606184|OTHER||Mean Difference (Net)|-3.63||||0.031|TWO_SIDED|95.0|-6.92|-0.33||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||TJC28, Week 12|||-0.33|-6.92|0.031
71049178|NCT02504671|141606184|OTHER||Mean Difference (Net)|-6.32|||<|0.001|TWO_SIDED|95.0|-9.61|-3.02||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||TJC28, Week 12|||-3.02|-9.61|<0.001
71104478|NCT04380142|141716295|SUPERIORITY||LS Mean of Difference|-2.73|STANDARD_ERROR_OF_MEAN|1.96||0.1656|TWO_SIDED|95.0|-6.61|1.15||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|Repeated measures model|||||1.15|-6.61|0.1656
71049179|NCT02504671|141606185|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049180|NCT02504671|141606185|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||10.3|-10.3|
71049181|NCT02504671|141606185|OTHER||Difference|-5.4|||||TWO_SIDED|95.0|-12.7|1.9|||||Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||1.9|-12.7|
71104479|NCT04380142|141716296|SUPERIORITY||LS Mean of Difference|-5.49|STANDARD_ERROR_OF_MEAN|3.65||0.1347|TWO_SIDED|95.0|-12.71|1.73||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|Repeated measures model|||||1.73|-12.71|0.1347
70929848|NCT03988621|141357293|SUPERIORITY||Mean Difference (Net)|-0.65||||0.04|TWO_SIDED|95.0|-1.27|-0.03||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis||Mean HSCN scale scores of participants in the intervention group were estimated to decrease by 0.65 (95% CI: -1.27 to -0.03) units more than that of participants in the control group from baseline to 6-months.|||-0.03|-1.27|0.04
70929849|NCT03988621|141357294|SUPERIORITY||Mean Difference (Net)|5.05||||0.01|TWO_SIDED|95.0|1.12|8.98||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis||Mean Self Care Inventory scale scores of participants in the intervention group were estimated to increase by 5.05 (95% CI: 1.12 to 8.98) units more than that of participants in the control group from baseline to 6-months.|||8.98|1.12|0.01
70929850|NCT03988621|141357295|SUPERIORITY||Mean Difference (Net)|-4.5|||<|0.0001|TWO_SIDED|95.0|-6.48|-2.52||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis||Mean PSS scale scores of participants in the intervention group were estimated to decrease by 4.50 (95% CI: -6.48 to -2.52) units more than that of participants in the control group from baseline to 6-months.|||-2.52|-6.48|<0.0001
70929851|NCT03988621|141357296|SUPERIORITY||Mean Difference (Net)|2.16||||0.099|TWO_SIDED|95.0|-0.41|4.73||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis|||Active Coping Subscale||4.73|-0.41|0.099
70929852|NCT03988621|141357296|SUPERIORITY||Mean Difference (Net)|-0.88||||0.25|TWO_SIDED|95.0|-2.38|0.62||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis||Estimated difference may not be consistent with difference sample means presented in outcome measure data table.|Avoidance Coping Subscale||0.62|-2.38|0.25
70929853|NCT03988621|141357296|SUPERIORITY|The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mean Difference (Net)|-0.31||||0.68|TWO_SIDED|95.0|-1.81|1.18|||Mixed Models Analysis|||Minimization Coping Subscale||1.18|-1.81|0.68
71014754|NCT05182840|141536682|OTHER||Odds Ratio (OR)|4.69||||0.0001|TWO_SIDED|95.0|2.15|10.24||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||10.24|2.15|0.0001
71014755|NCT05182840|141536683|OTHER||Odds Ratio (OR)|2.88||||0.0195|TWO_SIDED|95.0|1.19|7.02||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.02|1.19|0.0195
71014756|NCT05182840|141536683|OTHER||Odds Ratio (OR)|6.38||||0|TWO_SIDED|95.0|2.65|15.35||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||15.35|2.65|0.0000
71049182|NCT02504671|141606185|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||10.3|-10.3|
71049183|NCT02504671|141606185|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
71049184|NCT02504671|141606185|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
71049185|NCT02504671|141606185|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71049186|NCT02504671|141606185|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71049187|NCT02504671|141606185|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
70929854|NCT03988621|141357297|SUPERIORITY||Mean Difference (Net)|-1.32||||0.27|TWO_SIDED|95.0|-3.68|1.04||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis|||Physical Health Score||1.04|-3.68|0.27
70929855|NCT03988621|141357297|SUPERIORITY||Mean Difference (Net)|3.35||||0.04|TWO_SIDED|95.0|0.17|6.53||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis||Mean Mental Health scores of participants in the intervention group were estimated to increase by 3.35 (95% CI: 0.17 to 6.53) units more than that of participants in the control group from baseline to 6-months.|Mental Health Score||6.53|0.17|0.04
70929856|NCT03988621|141357300|SUPERIORITY||Mean Difference (Final Values)|1.3472||||0.5433|TWO_SIDED|95.0|0.5153|3.5218|||Regression, zero inflated poisson||Estimation accounts for the zero-inflated distribution of hospitalization count, thus estimate is inconsistent with mean values in the Outcome Measure Data table|||3.5218|0.5153|0.5433
70929857|NCT03988621|141357301|SUPERIORITY||Mean Difference (Final Values)|1.0143||||0.9173|TWO_SIDED|95.0|0.7766|1.3247|||Zero-inflated poisson regression|||||1.3247|0.7766|0.9173
71049188|NCT02504671|141606185|OTHER||Difference|21.6|||||TWO_SIDED|95.0|6.8|36.4|||||Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||36.4|6.8|
71049189|NCT02504671|141606185|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049190|NCT02504671|141606185|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71049191|NCT02504671|141606185|OTHER||Difference|27.0|||||TWO_SIDED|95.0|12.7|41.3|||||Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||41.3|12.7|
71049192|NCT02504671|141606185|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
71049193|NCT02504671|141606185|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71014757|NCT05182840|141536683|OTHER||Odds Ratio (OR)|6.39||||0.0001|TWO_SIDED|95.0|2.6|15.67||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||15.67|2.60|0.0001
71014758|NCT05182840|141536684|OTHER||Odds Ratio (OR)|1.82||||0.1398|TWO_SIDED|95.0|0.82|4.04||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.04|0.82|0.1398
71014759|NCT05182840|141536684|OTHER||Odds Ratio (OR)|8.42||||0|TWO_SIDED|95.0|3.73|19.02||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||19.02|3.73|0.0000
71014760|NCT05182840|141536684|OTHER|P-value was rounded to four decimal places.|Odds Ratio (OR)|4.98||||0.0001|TWO_SIDED|95.0|2.28|10.9|||Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||10.90|2.28|0.0001
71014761|NCT05182840|141536685|OTHER||Odds Ratio (OR)|1.71||||0.1884|TWO_SIDED|95.0|0.77|3.79||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.79|0.77|0.1884
71049194|NCT02504671|141606185|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71049195|NCT02504671|141606185|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
71049196|NCT02504671|141606185|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049197|NCT02504671|141606185|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71049198|NCT02504671|141606185|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
71049199|NCT02504671|141606185|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049200|NCT02504671|141606185|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049201|NCT02504671|141606185|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
71049202|NCT02504671|141606185|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
71049203|NCT02504671|141606185|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71049204|NCT02504671|141606185|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
70850605|NCT02712047|141189438|OTHER||Mean Difference (Net)|19.33|||||TWO_SIDED|95.0|-3.0|41.66|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 4, AM|||41.66|-3.00|
70929858|NCT03988621|141357302|SUPERIORITY|||||||0.6486|||||||Fisher Exact|||||||0.6486
71014762|NCT05182840|141536685|OTHER||Odds Ratio (OR)|6.8||||0|TWO_SIDED|95.0|2.94|15.72||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||15.72|2.94|0.0000
71014763|NCT05182840|141536685|OTHER||Odds Ratio (OR)|4.46||||0.0003|TWO_SIDED|95.0|2.0|9.94||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||9.94|2.00|0.0003
71014764|NCT05182840|141536686|OTHER||Odds Ratio (OR)|1.62||||0.214|TWO_SIDED|95.0|0.76|3.46||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.46|0.76|0.2140
71014765|NCT05182840|141536686|OTHER||Odds Ratio (OR)|4.13||||0.0003|TWO_SIDED|95.0|1.93|8.85||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.85|1.93|0.0003
71014766|NCT05182840|141536686|OTHER||Odds Ratio (OR)|5.43||||0|TWO_SIDED|95.0|2.52|11.71||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||11.71|2.52|0.0000
71014767|NCT05182840|141536687|OTHER||Odds Ratio (OR)|1.71||||0.1884|TWO_SIDED|95.0|0.77|3.79||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.79|0.77|0.1884
71014768|NCT05182840|141536687|OTHER||Odds Ratio (OR)|6.8||||0|TWO_SIDED|95.0|2.94|15.72||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||15.72|2.94|0.0000
71049205|NCT02504671|141606185|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71049206|NCT02504671|141606185|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71049207|NCT02504671|141606185|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049208|NCT02504671|141606185|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71049209|NCT02504671|141606185|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71049210|NCT02504671|141606185|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
71049211|NCT02504671|141606185|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71049212|NCT02504671|141606185|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049213|NCT02504671|141606185|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049214|NCT02504671|141606185|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71049215|NCT02504671|141606185|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
70850606|NCT02712047|141189438|OTHER||Mean Difference (Net)|20.85|||||TWO_SIDED|95.0|-1.32|43.03|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 4, PM|||43.03|-1.32|
70929859|NCT03988621|141357303|SUPERIORITY|||||||0.6791|||||||t-test, 2 sided|||||||0.6791
70929860|NCT01447719|141357320|SUPERIORITY_OR_OTHER_LEGACY||Sensitivity|92.0|||||TWO_SIDED|95.0|78.0|98.0|||||95% CI calculated by Wilson score method|Proportion of subjects who had a positive scan based on majority of 5 blinded readers||98|78|
71014769|NCT05182840|141536687|OTHER||Odds Ratio (OR)|4.46||||0.0003|TWO_SIDED|95.0|2.0|9.94||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||9.94|2.00|0.0003
71014770|NCT05182840|141536688|OTHER||Odds Ratio (OR)|2.18||||0.0024|TWO_SIDED|95.0|1.32|3.61||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.61|1.32|0.0024
71014771|NCT05182840|141536688|OTHER||Odds Ratio (OR)|4.05||||0|TWO_SIDED|95.0|2.39|6.86||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.86|2.39|0.0000
71014772|NCT05182840|141536688|OTHER||Odds Ratio (OR)|3.87||||0|TWO_SIDED|95.0|2.29|6.55||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.55|2.29|0.0000
71014773|NCT05182840|141536689|OTHER||Odds Ratio (OR)|2.26||||0.0019|TWO_SIDED|95.0|1.35|3.77||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.77|1.35|0.0019
71014774|NCT05182840|141536689|OTHER||Odds Ratio (OR)|3.81||||0|TWO_SIDED|95.0|2.2|6.59||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.59|2.20|0.0000
71014775|NCT05182840|141536689|OTHER||Odds Ratio (OR)|3.67||||0|TWO_SIDED|95.0|2.12|6.35||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.35|2.12|0.0000
71014776|NCT05182840|141536690|OTHER||Odds Ratio (OR)|1.67||||0.0418|TWO_SIDED|95.0|1.02|2.74||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||2.74|1.02|0.0418
71014777|NCT05182840|141536690|OTHER||Odds Ratio (OR)|3.91||||0|TWO_SIDED|95.0|2.3|6.65||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.65|2.30|0.0000
71014778|NCT05182840|141536690|OTHER||Odds Ratio (OR)|3.58||||0|TWO_SIDED|95.0|2.11|6.05||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.05|2.11|0.0000
71049216|NCT02504671|141606185|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
70929861|NCT01447719|141357321|SUPERIORITY_OR_OTHER_LEGACY||Specificity|100.0|||||TWO_SIDED|95.0|80.0|100.0|||||95% CI calculated by Wilson score method|Proportion of subjects who had a negative scan based on majority of 5 blinded readers||100|80|
71049217|NCT02504671|141606185|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71049218|NCT02504671|141606185|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
71049219|NCT02504671|141606185|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
71049220|NCT02504671|141606185|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71014779|NCT05182840|141536691|OTHER||Odds Ratio (OR)|2.26||||0.0019|TWO_SIDED|95.0|1.35|3.77||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.77|1.35|0.0019
71014780|NCT05182840|141536691|OTHER||Odds Ratio (OR)|3.81||||0|TWO_SIDED|95.0|2.2|6.59||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.59|2.20|0.0000
71014781|NCT05182840|141536691|OTHER||Odds Ratio (OR)|3.67||||0|TWO_SIDED|95.0|2.12|6.35||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.35|2.12|0.0000
71014782|NCT05182840|141536692|OTHER||Odds Ratio (OR)|2.2||||0.0285|TWO_SIDED|95.0|1.09|4.45||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.45|1.09|0.0285
71014783|NCT05182840|141536692|OTHER||Odds Ratio (OR)|2.9||||0.0038|TWO_SIDED|95.0|1.41|5.96||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||5.96|1.41|0.0038
71014784|NCT05182840|141536692|OTHER||Odds Ratio (OR)|4.15||||0.0002|TWO_SIDED|95.0|1.97|8.72||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.72|1.97|0.0002
71014785|NCT05182840|141536693|OTHER||Odds Ratio (OR)|2.56||||0.0116|TWO_SIDED|95.0|1.23|5.31||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||5.31|1.23|0.0116
71014786|NCT05182840|141536693|OTHER||Odds Ratio (OR)|3.08||||0.0032|TWO_SIDED|95.0|1.46|6.52||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.52|1.46|0.0032
71014787|NCT05182840|141536693|OTHER||Odds Ratio (OR)|4.07||||0.0004|TWO_SIDED|95.0|1.86|8.91||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.91|1.86|0.0004
71014788|NCT05182840|141536694|OTHER||Odds Ratio (OR)|1.34||||0.4092|TWO_SIDED|95.0|0.67|2.69||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||2.69|0.67|0.4092
71049221|NCT02504671|141606185|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
71049222|NCT02504671|141606185|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 2. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
70850607|NCT02712047|141189438|OTHER||Mean Difference (Net)|16.82|||||TWO_SIDED|95.0|-5.47|39.11|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 5, AM|||39.11|-5.47|
70929862|NCT01447719|141357322|SUPERIORITY_OR_OTHER_LEGACY||Correlation coefficient|0.76|STANDARD_ERROR_OF_MEAN|0.133|<|0.0001|TWO_SIDED|95.0|0.62|0.85||A one-sided test (rho \> 0) was performed with a significance level of alpha=0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|Asymptotic standard error and 95 percent CI used Fisher z-transformation.||Spearman's Rank Order Correlation of the median semiquantitative read (three readers) and the quantitative IHC measurement of cortical amyloid plaque density averaged across six brain regions.||0.85|0.62|<0.0001
70929863|NCT01447719|141357323|SUPERIORITY_OR_OTHER_LEGACY||Sensitivity|96.0|||||TWO_SIDED|95.0|80.0|100.0||||||Proportion of subjects who had a positive scan based on majority of 5 blinded readers||100|80|
71014789|NCT05182840|141536694|OTHER||Odds Ratio (OR)|3.66||||0.0005|TWO_SIDED|95.0|1.77|7.58||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.58|1.77|0.0005
71014790|NCT05182840|141536694|OTHER||Odds Ratio (OR)|4.04||||0.0002|TWO_SIDED|95.0|1.92|8.49||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.49|1.92|0.0002
71014791|NCT05182840|141536695|OTHER||Odds Ratio (OR)|2.16||||0.0348|TWO_SIDED|95.0|1.06|4.43||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.43|1.06|0.0348
71014792|NCT05182840|141536695|OTHER||Odds Ratio (OR)|6.08||||0|TWO_SIDED|95.0|2.73|13.57||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||13.57|2.73|0.0000
71014793|NCT05182840|141536695|OTHER||Odds Ratio (OR)|3.58||||0.0007|TWO_SIDED|95.0|1.71|7.52||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.52|1.71|0.0007
71014794|NCT05182840|141536696|OTHER||Odds Ratio (OR)|2.01||||0.0578|TWO_SIDED|95.0|0.98|4.14||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.14|0.98|0.0578
70929864|NCT01447719|141357324|SUPERIORITY_OR_OTHER_LEGACY||Specificity|100.0|||||TWO_SIDED|95.0|78.0|100.0||||||Proportion of subjects who had a negative scan based on majority of 5 blinded readers||100|78|
71014795|NCT05182840|141536696|OTHER||Odds Ratio (OR)|5.12||||0.0001|TWO_SIDED|95.0|2.23|11.78||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||11.78|2.23|0.0001
71049223|NCT02504671|141606185|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049224|NCT02504671|141606185|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
70929865|NCT02938923|141357380|SUPERIORITY||Mean Difference (Final Values)|2.19||||0.853|TWO_SIDED|95.0|-21.16|25.54||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.19|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||25.54|-21.16|0.853
71049225|NCT02504671|141606185|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-11.7|6.3|||||95% CI were constructed using asymptotic Wald confidence limits without correction.|||6.3|-11.7|
71049226|NCT02504671|141606185|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-8.7|14.1|||||Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||14.1|-8.7|
71049227|NCT02504671|141606185|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
71049228|NCT02504671|141606185|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71104480|NCT02908178|141716303|OTHER||Odds Ratio (OR)|1.39|||<|0.001|TWO_SIDED|99.0|1.18|1.63||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Odds ratio accounts for matching and adjusted for subsequent mastectomy within 180 days after initial BCS, prior MRI, and radiation therapy status.|Testing the association between use of sentinel lymph node biopsy (SLNB) and any complication in the Aim 1 matched cohort.||1.63|1.18|<.001
71104481|NCT02908178|141716303|OTHER||Odds Ratio (OR)|4.45|||<|0.001|TWO_SIDED|99.0|2.27|8.75||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Odds ratio accounts for matching and adjusted for subsequent mastectomy within 180 days after initial BCS, prior MRI, and radiation therapy status|Testing the association between use of sentinel lymph node biopsy (SLNB) and lymphedema in the Aim 1 matched cohort.||8.75|2.27|<.001
70850608|NCT02712047|141189438|OTHER||Mean Difference (Net)|21.86|||||TWO_SIDED|95.0|-0.41|44.14|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 5, PM|||44.14|-0.41|
70929866|NCT02938923|141357380|SUPERIORITY||Mean Difference (Final Values)|5.04||||0.767|TWO_SIDED|95.0|-28.57|38.65||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.30|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||38.65|-28.57|0.767
71014796|NCT05182840|141536696|OTHER||Odds Ratio (OR)|3.32||||0.0022|TWO_SIDED|95.0|1.54|7.16||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.16|1.54|0.0022
71049229|NCT02504671|141606185|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
71049230|NCT02504671|141606185|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049231|NCT02504671|141606185|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049232|NCT02504671|141606185|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
71049233|NCT02504671|141606185|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71049234|NCT02504671|141606185|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049235|NCT02504671|141606185|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71104482|NCT02908178|141716303|OTHER||Odds Ratio (OR)|1.24|||<|0.001|TWO_SIDED|99.0|1.0|1.54||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Odds ratio accounts for matching and adjusted for subsequent mastectomy within 180 days after initial BCS, prior MRI, and radiation therapy status|Testing the association between use of sentinel lymph node biopsy (SLNB) and wound infection in the Aim 1 matched cohort.||1.54|1.00|<.001
70850609|NCT02712047|141189438|OTHER||Mean Difference (Net)|13.05|||||TWO_SIDED|95.0|-9.57|35.67|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 6, AM|||35.67|-9.57|
70850610|NCT02712047|141189438|OTHER||Mean Difference (Net)|28.68|||||TWO_SIDED|95.0|5.38|51.98|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 6, PM|||51.98|5.38|
70929867|NCT02938923|141357380|SUPERIORITY||Mean Difference (Final Values)|2.84||||0.868|TWO_SIDED|95.0|-30.93|36.62||Unadjusted p-value|Mixed Models Analysis|t (df,112) = 0.17|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||36.62|-30.93|0.868
71049236|NCT02504671|141606185|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71049237|NCT02504671|141606185|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71049238|NCT02504671|141606185|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
71049239|NCT02504671|141606185|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
71049240|NCT02504671|141606185|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71049241|NCT02504671|141606185|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049242|NCT02504671|141606185|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 36, 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71049243|NCT02504671|141606185|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71049244|NCT02504671|141606185|OTHER||Difference|24.3|||||TWO_SIDED|95.0|10.5|38.1|||||Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||38.1|10.5|
71049245|NCT02504671|141606185|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71049246|NCT02504671|141606185|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049247|NCT02504671|141606185|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71049248|NCT02504671|141606185|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
71014797|NCT05182840|141536697|OTHER||Odds Ratio (OR)|2.17||||0.0342|TWO_SIDED|95.0|1.06|4.44||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.44|1.06|0.0342
71014798|NCT05182840|141536697|OTHER||Odds Ratio (OR)|4.23||||0.0003|TWO_SIDED|95.0|1.93|9.24||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||9.24|1.93|0.0003
71014799|NCT05182840|141536697|OTHER||Odds Ratio (OR)|3.19||||0.0023|TWO_SIDED|95.0|1.52|6.73||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.73|1.52|0.0023
71014800|NCT05182840|141536698|OTHER||Odds Ratio (OR)|2.56||||0.0116|TWO_SIDED|95.0|1.23|5.31||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||5.31|1.23|0.0116
71014801|NCT05182840|141536698|OTHER||Odds Ratio (OR)|3.08||||0.0032|TWO_SIDED|95.0|1.46|6.52||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.52|1.46|0.0032
71014802|NCT05182840|141536698|OTHER||Odds Ratio (OR)|4.07||||0.0004|TWO_SIDED|95.0|1.86|8.91||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.91|1.86|0.0004
71014803|NCT05182840|141536699|OTHER||Odds Ratio (OR)|2.01||||0.0578|TWO_SIDED|95.0|0.98|4.14||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.14|0.98|0.0578
71014804|NCT05182840|141536699|OTHER||Odds Ratio (OR)|5.12||||0.0001|TWO_SIDED|95.0|2.23|11.78||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||11.78|2.23|0.0001
71014805|NCT05182840|141536699|OTHER||Odds Ratio (OR)|3.32||||0.0022|TWO_SIDED|95.0|1.54|7.16||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.16|1.54|0.0022
71049249|NCT02504671|141606185|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71049250|NCT02504671|141606185|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71049251|NCT02504671|141606185|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
71049252|NCT02504671|141606185|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71049253|NCT02504671|141606186|OTHER||Mean Difference (Net)|-0.32||||0.046|TWO_SIDED|95.0|-0.64|-0.01||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1|||-0.01|-0.64|0.046
71014806|NCT00863265|141536702|EQUIVALENCE||Mean Difference (Final Values)|289.0||||0.01|TWO_SIDED||||||ANOVA||The estimation parameter is the difference between the placebo group and the ezetimibe group.|Phytosterol Diet compared to Ezetimibe||||0.01
71014807|NCT00863265|141536702|EQUIVALENCE|The hypothesis is that groups are equal.|Mean Difference (Final Values)|457.0|||<|0.01|TWO_SIDED||||||ANOVA|||Placebo vs. Ezetimibe Plus Phytosterols||||<0.01
71014808|NCT00863265|141536702|EQUIVALENCE|The hypothesis is that groups are equal|Mean Difference (Final Values)|168.0|||<|0.01|TWO_SIDED||||||ANOVA|||Ezetimibe vs. Ezetimibe Plus Phytosterols||||<0.01
71014809|NCT00863265|141536703|EQUIVALENCE|Not applicable in this study.|Mean Difference (Final Values)|22.8|||<|0.01|TWO_SIDED|||||Adjusted for multiple comparisons.|ANOVA|||The hypothesis is that groups are equal||||<0.01
71014810|NCT00863265|141536703|EQUIVALENCE||Mean Difference (Final Values)|36.4|||<|0.01|TWO_SIDED|||||Adjusted for multiple comparisons.|ANOVA|||Placebo vs. Ezetimibe Plus Phytosterols||||<0.01
71014811|NCT00863265|141536703|EQUIVALENCE||Mean Difference (Final Values)|13.6|||<|0.01|TWO_SIDED|||||Adjusted for multiple comparisons.|ANOVA|||The hypothesis is that groups are equal.||||<0.01
71014812|NCT00863265|141536704|EQUIVALENCE||Mean Difference (Final Values)|21.0|||<|0.01|TWO_SIDED||||||ANOVA|||The hypothesis is that groups are equal.||||<0.01
71014813|NCT00863265|141536704|EQUIVALENCE||Mean Difference (Final Values)|28.0|||<|0.01|TWO_SIDED|||||Adjusted for multiple comparisons.|ANOVA|||The hypothesis is that all groups are equal||||<0.01
71014814|NCT00863265|141536704|EQUIVALENCE||Mean Difference (Final Values)|7.0|||<|0.05|TWO_SIDED|||||Adjusted for multiple comparisons.|ANOVA|||The hypothesis is that groups are equal.||||<0.05
71014815|NCT02268214|141536705|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.0697|<|0.0001|TWO_SIDED|95.0|-0.56|-0.28|||RMM|Repeated Measures Model||||-0.28|-0.56|<0.0001
71014816|NCT02268214|141536705|SUPERIORITY||Median Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.0696|<|0.0001|TWO_SIDED|95.0|-0.58|-0.31|||RMM|Repeated Measures Model||||-0.31|-0.58|<0.0001
71014817|NCT02268214|141536706|SUPERIORITY||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|1.9555|<|0.0001|TWO_SIDED|95.0|-12.56|-4.88|||RMM|Repeated Measures Model||||-4.88|-12.56|<0.0001
71014818|NCT02268214|141536706|SUPERIORITY||Mean Difference (Final Values)|-13.17|STANDARD_ERROR_OF_MEAN|1.8643|<|0.0001|TWO_SIDED|95.0|-16.75|-9.43|||RMM|Repeated Measures Model||||-9.43|-16.75|<0.0001
71014819|NCT02268214|141536707|SUPERIORITY||Mean Difference (Final Values)|-3.05|STANDARD_ERROR_OF_MEAN|0.3251|<|0.0001|TWO_SIDED|95.0|-3.68|-2.41|||RMM|Repeated Measures Model||||-2.41|-3.68|<0.0001
71104483|NCT02908178|141716303|OTHER||Odds Ratio (OR)|1.4|||<|0.001|TWO_SIDED|99.0|1.03|1.91||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Odds ratio accounts for matching and adjusted for subsequent mastectomy within 180 days after initial BCS, prior MRI, and radiation therapy status|Testing the association between use of sentinel lymph node biopsy (SLNB) and seroma in the Aim 1 matched cohort.||1.91|1.03|<.001
71014820|NCT02268214|141536707|SUPERIORITY||Mean Difference (Final Values)|-3.72|STANDARD_ERROR_OF_MEAN|0.3213|<|0.0001|TWO_SIDED|95.0|-4.34|-3.08|||RMM|Repeated Measures Model||||-3.08|-4.34|<0.0001
71014821|NCT02268214|141536708|SUPERIORITY||Mean Difference (Final Values)|-15.34|STANDARD_ERROR_OF_MEAN|2.4859|<|0.0001|TWO_SIDED|95.0|-20.22|-10.46|||RMM|Repeated Measures Model||||-10.46|-20.22|<0.0001
71014822|NCT02268214|141536708|SUPERIORITY||Mean Difference (Final Values)|-18.03|STANDARD_ERROR_OF_MEAN|2.505|<|0.0001|TWO_SIDED|95.0|-22.95|-13.11|||RMM|Repeated Measures Model||||-13.11|-22.95|<0.0001
71014823|NCT02268214|141536709|SUPERIORITY||Mean Difference (Final Values)|-17.3|STANDARD_ERROR_OF_MEAN|2.6273|<|0.0001|TWO_SIDED|95.0|-22.46|-12.14|||RMM|Repeated Measures Model||||-12.14|-22.46|<0.0001
71014824|NCT02268214|141536709|SUPERIORITY||Mean Difference (Final Values)|-18.93|STANDARD_ERROR_OF_MEAN|2.6482|<|0.0001|TWO_SIDED|95.0|-24.13|-13.73|||RMM|Repeated Measures Model||||-13.73|-24.13|<0.0001
71014825|NCT02268214|141536710|SUPERIORITY||Mean Difference (Final Values)|9.11|STANDARD_ERROR_OF_MEAN|1.1611|<|0.0001|TWO_SIDED|95.0|6.83|11.39|||RMM|Repeated Measures Model||||11.39|6.83|<0.0001
71014826|NCT02268214|141536710|SUPERIORITY||Mean Difference (Final Values)|10.65|STANDARD_ERROR_OF_MEAN|1.1689|<|0.0001|TWO_SIDED|95.0|8.35|12.94|||RMM|Repeated Measures Model||||12.94|8.35|<0.0001
71014827|NCT02268214|141536711|SUPERIORITY||Odds Ratio (OR)|3.09|STANDARD_ERROR_OF_MEAN|0.198|<|0.0001|TWO_SIDED|95.0|2.1|4.56|||Regression, Logistic|||||4.56|2.10|<0.0001
71014828|NCT02268214|141536711|SUPERIORITY||Odds Ratio (OR)|3.29|STANDARD_ERROR_OF_MEAN|0.1979|<|0.0001|TWO_SIDED|95.0|2.23|4.85|||Regression, Logistic|||||4.85|2.23|<0.0001
71014829|NCT04342390|141536712|SUPERIORITY|||||||0.363|||||||ANCOVA|||||||0.363
71014830|NCT04342390|141536713|SUPERIORITY|||||||0.633|||||||ANCOVA|||||||0.633
71014831|NCT04342390|141536714|SUPERIORITY|||||||0.433|||||||ANCOVA|||||||0.433
71014832|NCT04342390|141536715|SUPERIORITY|||||||0.822|||||||ANCOVA|||||||0.822
71014833|NCT04342390|141536716|SUPERIORITY|||||||0.554|||||||ANCOVA|||||||0.554
71014834|NCT04342390|141536717|SUPERIORITY|||||||0.186|||||||ANCOVA|||||||0.186
71014835|NCT04342390|141536718|SUPERIORITY|||||||0.921|||||||ANCOVA|||||||0.921
71014836|NCT00318357|141536738|SUPERIORITY|||||||0.007|||||||Regression, Cox|||Mortality is compared between the arms of the CARE-HF study, using Cox proportional hazards regression. Data from the original CARE-HF trial and the CARE-HF Long Term Follow-up trial were combined for the analysis.||||0.007
71014837|NCT00948896|141536739|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Negative Binomial Regression|||Null Hypothesis: Within HIV-unexposed participants, there is no difference in the incidence of all grade 3-4 adverse events per PYAR between the control arm and the monthly DP arm.||||<0.0001
71014838|NCT00948896|141536739|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Monthly DP arm compared to No chemoprevention arm|Negative Binomial Regression|||Null Hypothesis: Within HIV-unexposed participants, there is no difference in the incidence of elevated temperature adverse events per PYAR between the control arm and the monthly DP arm.||||<0.01
71014839|NCT00948896|141536739|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Monthly DP arm compared to No chemoprevention arm|Negative Binomial Regression|||Null Hypothesis: Within HIV-unexposed participants, there is no difference in the incidence of anemia adverse events per PYAR between the control arm and the monthly DP arm.||||<0.01
70929868|NCT02938923|141357380|SUPERIORITY||Mean Difference (Final Values)|0.63||||0.96|TWO_SIDED|95.0|-24.26|25.52||Unadjusted p-value|Mixed Models Analysis|t (df, 217) = 0.05|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||25.52|-24.26|0.960
70929869|NCT02938923|141357380|SUPERIORITY||Mean Difference (Final Values)|8.42||||0.63|TWO_SIDED|95.0|-25.97|42.82||Unadjusted p-value|Mixed Models Analysis|t (df, 217) = 0.48|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||42.82|-25.97|0.630
70929870|NCT02938923|141357380|SUPERIORITY||Mean Difference (Final Values)|7.79||||0.657|TWO_SIDED|95.0|-26.77|42.36||Unadjusted p-value|Mixed Models Analysis|t (df, 217) = 0.44|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||42.36|-26.77|0.657
71104484|NCT02908178|141716303|OTHER||Odds Ratio (OR)|1.31||||0.003|TWO_SIDED|99.0|1.04|1.65||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Odds ratio accounts for matching and adjusted for subsequent mastectomy within 180 days after initial BCS, prior MRI, and radiation therapy status|Testing the association between use of sentinel lymph node biopsy (SLNB) and pain in the Aim 1 matched cohort.||1.65|1.04|.003
71104485|NCT02908178|141716304|OTHER||||||<|0.001||||||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared|||Testing the association between receipt of SLNB and receipt of mastectomy within 6 months of DCIS diagnosis.||||<.001
71104486|NCT02908178|141716305|OTHER|||||||0.48||||||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared|||Testing the association between receipt of SLNB and receipt of radiation therapy within 9 months of DCIS diagnosis.||||.48
71104487|NCT02908178|141716306|OTHER||Hazard Ratio (HR)|0.88|||<|0.001|TWO_SIDED|99.0|0.73|1.05||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and overall mortality in the Aim 2 matched cohort.||1.05|0.73|<.001
71104488|NCT02908178|141716307|OTHER||Hazard Ratio (HR)|1.09||||0.207|TWO_SIDED|99.0|1.0|1.2||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and any side effects in the matched Aim 2 cohort.||1.20|1.00|0.207
71104489|NCT02908178|141716307|OTHER||Hazard Ratio (HR)|1.53|||<|0.001|TWO_SIDED|99.0|1.12|2.11||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and lymphedema related complications in the Aim 2 matched cohort.||2.11|1.12|<.001
71104490|NCT02908178|141716307|OTHER||Hazard Ratio (HR)|0.98||||0.113|TWO_SIDED|99.0|0.87|1.1||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and any infection in the Aim 2 matched cohort.||1.10|0.87|0.113
71104491|NCT02908178|141716307|OTHER||Hazard Ratio (HR)|1.21||||0.01|TWO_SIDED|99.0|0.93|1.58||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and seroma in the Aim 2 matched cohort.||1.58|0.93|0.010
71104492|NCT02908178|141716307|OTHER||Hazard Ratio (HR)|1.1||||0.029|TWO_SIDED|99.0|0.98|1.25||P-value is unadjusted. Threshold for statistical significance is 0.01|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and pain in the Aim 2 matched cohort.||1.25|0.98|0.029
70929871|NCT02938923|141357380|SUPERIORITY||Mean Difference (Final Values)|-5.08||||0.627|TWO_SIDED|95.0|-25.72|15.56||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.49|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||15.56|-25.72|0.627
70929872|NCT02938923|141357380|SUPERIORITY||Mean Difference (Final Values)|-13.5||||0.364|TWO_SIDED|95.0|-42.86|15.86||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.91|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||15.86|-42.86|0.364
70929873|NCT02938923|141357380|SUPERIORITY||Mean Difference (Final Values)|-8.42||||0.574|TWO_SIDED|95.0|-38.0|21.15||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.56|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||21.15|-38.00|0.574
70929874|NCT02938923|141357380|SUPERIORITY||Mean Difference (Final Values)|-5.51||||0.557|TWO_SIDED|95.0|-23.96|12.94||Unadjusted p-value|Mixed Models Analysis|t (df, 217) = -0.59|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||12.94|-23.96|0.557
70929875|NCT02938923|141357380|SUPERIORITY||Mean Difference (Final Values)|-13.65||||0.302|TWO_SIDED|95.0|-39.64|12.35||Unadjusted p-value|Mixed Models Analysis|t (df, 217) = -1.03|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||12.35|-39.64|0.302
70929876|NCT02938923|141357380|SUPERIORITY||Mean Difference (Final Values)|-8.14||||0.541|TWO_SIDED|95.0|-34.33|18.06||Unadjusted p-value|Mixed Models Analysis|t (df, 217) = -0.61|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||18.06|-34.33|0.541
71014840|NCT00948896|141536739|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Monthly DP arm compared to No chemoprevention arm|Negative Binomial Regression|||Null Hypothesis: Within HIV-unexposed participants, there is no difference in the incidence of thrombocytopenia adverse events per PYAR between the control arm and the monthly DP arm.||||<0.05
71014841|NCT00948896|141536739|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Monthly DP arm compared with no chemoprevention arm.|Negative Binomial Regression|||Null Hypothesis: Within HIV-exposed participants, there is no difference in the incidence of all grade 3-4 adverse events per PYAR between the control arm and the monthly DP arm.||||<0.05
71014842|NCT00948896|141536739|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Monthly DP arm compared with no chemoprevention arm.|Negative Binomial Regression|||Null Hypothesis: Within HIV-exposed participants, there is no difference in the incidence of anemia adverse events per PYAR between the control arm and the monthly DP arm||||<0.05
71014843|NCT00948896|141536739|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Monthly DP arm compared with the no chemoprevention arm.|Negative Binomial Regression|||Null Hypothesis: Within HIV-exposed participants, there is no difference in the incidence of elevated temperature adverse events per PYAR between the control arm and the monthly DP arm||||<0.05
71014844|NCT00948896|141536739|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Daily TS arm compare with the no chemoprevention arm.|Negative Binomial Regression|||Null Hypothesis: Within HIV-exposed participants, there is no difference in the incidence of anemia adverse events per PYAR between the control arm and the daily TS arm||||<0.01
71014845|NCT00948896|141536741|SUPERIORITY_OR_OTHER||Protective Efficacy (%)|7.0||||0.57|TWO_SIDED|95.0|-19.0|28.0|||Negative Binomial Regression||The no chemoprevention arm is the reference group.|The sample size was calculated to detect at least a 32% lower incidence of malaria in the DP arm compared to that in the TS arm. We assumed that the incidence of malaria would be 1.85 episodes per person-year with TS chemoprevention based on a prior cohort study in the same area, and thus we calculated that we would need to enroll 100 participants in each arm to detect our targeted protective efficacy with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.||28|-19|0.57
71014846|NCT00948896|141536741|SUPERIORITY_OR_OTHER||Protective Efficacy (%)|28.0||||0.01|TWO_SIDED|95.0|7.0|44.0|||Negative Binomial Regression||The no chemoprevention arm is the reference arm.|The sample size was calculated to detect at least a 32% lower incidence of malaria in the DP arm compared to that in the TS arm. We assumed that the incidence of malaria would be 1.85 episodes per person-year with TS chemoprevention based on a prior cohort study in the same area, and thus we calculated that we would need to enroll 100 participants in each arm to detect our targeted protective efficacy with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.||44|7|0.01
71014847|NCT00948896|141536741|SUPERIORITY_OR_OTHER||Protective Efficacy (%)|58.0|||<|0.001|TWO_SIDED|95.0|45.0|67.0|||Negative Binomial Regression||The no chemoprevention arm is the reference arm.|The sample size was calculated to detect at least a 32% lower incidence of malaria in the DP arm compared to that in the TS arm. We assumed that the incidence of malaria would be 1.85 episodes per person-year with TS chemoprevention based on a prior cohort study in the same area, and thus we calculated that we would need to enroll 100 participants in each arm to detect our targeted protective efficacy with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.||67|45|<0.001
71014848|NCT00948896|141536742|SUPERIORITY_OR_OTHER||Protective Efficacy (%)|9.0||||0.065|TWO_SIDED|95.0|-35.0|38.0|||Negative Binomial Regression||The no chemoprevention arm is the reference arm.|We assumed that the incidence of malaria would be 1.85 episodes per person year with TS based on a prior cohort study in the same area, and thus, that we would need to enroll 50 participants in each arm to detect a reduction in the incidence of malaria in either the monthly SP or DP arms (two-sided significance level 0.05) compared with the daily TS arm of 48% or greater with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.||38|-35|0.065
71029296|NCT01046253|141566126|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Slope|98.0|||||TWO_SIDED|90.0|92.8|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104|92.8|
71029297|NCT00860028|141566150|SUPERIORITY_OR_OTHER_LEGACY|||||||0.36||95.0|||||Chi-squared|||||||0.36
71029298|NCT00860028|141566151|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06||95.0|||||General Linear Model|||||||0.06
71029299|NCT00860028|141566152|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0|||||Fisher Exact|||||||0.03
71029300|NCT01658943|141566156|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Log Rank|||||||0.15
71029301|NCT01054599|141566195|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71029302|NCT01054599|141566198|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||||||>0.05
70929877|NCT02938923|141357381|SUPERIORITY||Mean Difference (Final Values)|357.72||||0.336|TWO_SIDED|95.0|-375.75|1091.19||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.97|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||1091.19|-375.75|0.336
70929878|NCT02938923|141357381|SUPERIORITY||Mean Difference (Final Values)|936.93||||0.09|TWO_SIDED|95.0|-147.56|2021.42||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 1.71|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||2021.42|-147.56|0.090
71014849|NCT00948896|141536742|SUPERIORITY_OR_OTHER||Protective Efficacy (%)|49.0||||0.001|TWO_SIDED|95.0|23.0|66.0||Adjusted for age at randomization and incidence of malaria prior to randomization.|Negative Binomial Regression||Adjusted for age at randomization and incidence of malaria prior to randomization. The no chemoprevention arm is the reference arm.|We assumed that the incidence of malaria would be 1.85 episodes per person year with TS based on a prior cohort study in the same area, and thus, that we would need to enroll 50 participants in each arm to detect a reduction in the incidence of malaria in either the monthly SP or DP arms (two-sided significance level 0.05) compared with the daily TS arm of 48% or greater with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.||66|23|0.001
71014850|NCT00948896|141536742|SUPERIORITY_OR_OTHER||Protective Efficacy (%)|69.0|||<|0.001|TWO_SIDED|95.0|53.0|80.0||Adjusted for age at randomization and incidence of malaria prior to randomization.|Negative Binomial Regression||Adjusted for age at randomization and incidence of malaria prior to randomization. The no chemoprevention arm is the reference arm.|We assumed that the incidence of malaria would be 1.85 episodes per person year with TS based on a prior cohort study in the same area, and thus, that we would need to enroll 50 participants in each arm to detect a reduction in the incidence of malaria in either the monthly SP or DP arms (two-sided significance level 0.05) compared with the daily TS arm of 48% or greater with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.||80|53|<0.001
71014851|NCT01054443|141536796|OTHER||Cochran-Armitage Trend Test Statistic|0.173||||0.431|||||||Cochran-Armitage Trend Test|||The primary efficacy evaluation was to test if there was a linear relationship existing such that the higher the dose level, the larger the percentage of responders. The Cochran-Armitage trend test was employed by assigning the score 0, 0.5, 0.75, and 1 to placebo, lusutrombopag 0.5, 0.75, and 1.0 mg group, respectively, at the 0.025 level of significance (1-sided) to determine the test statistic for detecting a dose-response in the percentage of responders.||||0.431
70929879|NCT02938923|141357381|SUPERIORITY||Mean Difference (Final Values)|579.21||||0.297|TWO_SIDED|95.0|-515.36|1673.78||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 1.05|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||1673.78|-515.36|0.297
70929880|NCT02938923|141357381|SUPERIORITY||Mean Difference (Final Values)|383.36||||0.245|TWO_SIDED|95.0|-266.06|1032.79||Unadjusted p-value|Mixed Models Analysis|t (df, 107) = 1.17|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||1032.79|-266.06|0.245
70850611|NCT02712047|141189438|OTHER||Mean Difference (Net)|17.09|||||TWO_SIDED|95.0|-5.08|39.26|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 7, AM|||39.26|-5.08|
70850612|NCT02712047|141189438|OTHER||Mean Difference (Net)|23.61|||||TWO_SIDED|95.0|0.28|46.94|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 7, PM|||46.94|0.28|
71029303|NCT00023309|141566243|SUPERIORITY_OR_OTHER|||||||0.0294||95.0|||||Fisher Exact|||Null hypothesis: there is no difference in the treatment effect between the two groups||||0.0294
71029304|NCT00023309|141566244|SUPERIORITY_OR_OTHER|||||||0.0325||95.0|||||Fisher Exact|||Null hypothesis: there is no difference in treatment effect at week 196||||0.0325
71029305|NCT00023309|141566245|SUPERIORITY_OR_OTHER|||||||0.0049||95.0|||||Fisher Exact|||Null hypothesis: there is no difference in treatment effect at week 196||||0.0049
71029306|NCT00023309|141566246|SUPERIORITY_OR_OTHER|||||||0.0157||95.0|||||Fisher Exact|||Null hypothesis: there is no difference in treatment effect at week 196||||0.0157
71029307|NCT00023309|141566247|SUPERIORITY_OR_OTHER|||||||0.0913||95.0|||||Fisher Exact|||Null hypothesis: there is no difference in treatment effect at week 196||||0.0913
71029308|NCT03247556|141566248|SUPERIORITY||Least Square Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|1.93||0.0082|TWO_SIDED|95.0|-8.9|-1.3|||Mixed Model for Repeated Measures|||||-1.3|-8.9|0.0082
71029309|NCT03247556|141566248|SUPERIORITY||Least Square Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|1.93||0.0712|TWO_SIDED|95.0|-7.3|0.3|||Mixed Model for Repeated Measures|||||0.3|-7.3|0.0712
71029310|NCT03247556|141566249|SUPERIORITY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.0051|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.1|-0.8|0.0051
71029311|NCT03247556|141566249|SUPERIORITY||Least Square Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.0995|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||0.1|-0.6|0.0995
71029312|NCT03247556|141566250|SUPERIORITY||Least Square Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.26||0.1377|TWO_SIDED|95.0|-4.3|0.6|||ANCOVA|||||0.6|-4.3|0.1377
71029313|NCT03247556|141566250|SUPERIORITY||Least Square Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|1.25||0.313|TWO_SIDED|95.0|-3.7|1.2|||ANCOVA|||||1.2|-3.7|0.3130
71029314|NCT03247556|141566251|SUPERIORITY||Least Square Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.049||0.0698|TWO_SIDED|95.0|-0.19|0.01|||ANCOVA|||||0.01|-0.19|0.0698
71029315|NCT03247556|141566251|SUPERIORITY||Least Square Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.9756|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||||0.10|-0.10|0.9756
71029316|NCT03247556|141566252|SUPERIORITY||Risk Difference (RD)|15.3||||0.0349|TWO_SIDED|95.0|1.3|29.3|||Regression, Logistic|||||29.3|1.3|0.0349
71029317|NCT03247556|141566252|SUPERIORITY||Risk Difference (RD)|13.1||||0.0698|TWO_SIDED|95.0|-0.9|27.0|||Regression, Logistic|||||27.0|-0.9|0.0698
71029318|NCT03247556|141566253|SUPERIORITY||Least Square Mean Difference|-7.3|STANDARD_ERROR_OF_MEAN|4.76||0.1259|TWO_SIDED|95.0|-16.6|2.0|||ANCOVA|||||2.0|-16.6|0.1259
71029319|NCT03247556|141566253|SUPERIORITY||Least Square Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|4.78||0.7417|TWO_SIDED|95.0|-7.8|10.9|||ANCOVA|||||10.9|-7.8|0.7417
71029320|NCT03247556|141566254|SUPERIORITY||Least Square Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.97||0.0484|TWO_SIDED|95.0|-3.8|0.0|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-0.0|-3.8|0.0484
71029321|NCT03247556|141566254|SUPERIORITY||Least Square Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.96||0.2084|TWO_SIDED|95.0|-3.1|0.7|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||0.7|-3.1|0.2084
71029322|NCT03247556|141566254|SUPERIORITY||Least Square Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.06||0.0042|TWO_SIDED|95.0|-5.1|-1.0|||ANCOVA|||This analysis pertains to the Inattention subscale score||-1.0|-5.1|0.0042
71029323|NCT03247556|141566254|SUPERIORITY||Least Square Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|1.06||0.1392|TWO_SIDED|95.0|-3.6|0.5|||ANCOVA|||This analysis pertains to the Inattention subscale score||0.5|-3.6|0.1392
71029324|NCT03247556|141566255|SUPERIORITY||Least Square Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.07||0.381|TWO_SIDED|95.0|-3.0|1.2|||ANCOVA|||||1.2|-3.0|0.3810
71029325|NCT03247556|141566255|SUPERIORITY||Least Square Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|1.08||0.0432|TWO_SIDED|95.0|-4.3|-0.1|||ANCOVA|||||-0.1|-4.3|0.0432
71029326|NCT03247556|141566256|SUPERIORITY|||||||0.1433|||||||Chi-squared|||This analysis pertains to Week 1||||0.1433
71029327|NCT03247556|141566256|SUPERIORITY|||||||0.0114|||||||Chi-squared|||This analysis pertains to Week 2||||0.0114
71029328|NCT03247556|141566256|SUPERIORITY|||||||0.0008|||||||Chi-squared|||This analysis pertains to Week 3||||0.0008
71029329|NCT03247556|141566256|SUPERIORITY|||||||0.0197|||||||Chi-squared|||This analysis pertains to Week 4||||0.0197
71029330|NCT03247556|141566256|SUPERIORITY|||||||0.0573|||||||Chi-squared|||This analysis pertains to Week 5||||0.0573
71029331|NCT03247556|141566256|SUPERIORITY|||||||0.0105|||||||Chi-squared|||This analysis pertains to Week 6||||0.0105
71029332|NCT03247556|141566256|SUPERIORITY|||||||0.0004|||||||Chi-squared|||This analysis pertains to Week 7||||0.0004
71029333|NCT03247556|141566256|SUPERIORITY|||||||0.2573|||||||Chi-squared|||This analysis pertains to Week 1||||0.2573
71029334|NCT03247556|141566256|SUPERIORITY|||||||0.165|||||||Chi-squared|||This analysis pertains to Week 2||||0.1650
71029335|NCT03247556|141566256|SUPERIORITY|||||||0.0372|||||||Chi-squared|||This analysis pertains to Week 3||||0.0372
71029336|NCT03247556|141566256|SUPERIORITY|||||||0.1711|||||||Chi-squared|||This analysis pertains to Week 4||||0.1711
71029337|NCT03247556|141566256|SUPERIORITY|||||||0.1428|||||||Chi-squared|||This analysis pertains to Week 5||||0.1428
71029338|NCT03247556|141566256|SUPERIORITY|||||||0.2148|||||||Chi-squared|||This analysis pertains to Week 6||||0.2148
71029339|NCT03247556|141566256|SUPERIORITY|||||||0.0662|||||||Chi-squared|||This analysis pertains to Week 7||||0.0662
70929881|NCT02938923|141357381|SUPERIORITY||Mean Difference (Final Values)|836.64||||0.069|TWO_SIDED|95.0|-67.04|1740.32||Unadjusted p-value|Mixed Models Analysis|t (df, 107) = 1.84|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||1740.32|-67.04|0.069
70929882|NCT02938923|141357381|SUPERIORITY||Mean Difference (Final Values)|453.28||||0.327|TWO_SIDED|95.0|-459.13|1365.68||Unadjusted p-value|Mixed Models Analysis|t (df, 107) = 0.98|Difference between changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||1365.68|-459.13|0.327
70929883|NCT02938923|141357382|SUPERIORITY||Mean Difference (Final Values)|17.16||||0.934|TWO_SIDED|95.0|-391.74|426.05||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.08|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||426.05|-391.74|0.934
70929884|NCT02938923|141357382|SUPERIORITY||Mean Difference (Final Values)|562.64||||0.068|TWO_SIDED|95.0|-42.02|1167.31||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 1.84|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||1167.31|-42.02|0.068
70929885|NCT02938923|141357382|SUPERIORITY||Mean Difference (Final Values)|545.49||||0.079|TWO_SIDED|95.0|-64.81|1155.79||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 1.77|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||1155.79|-64.81|0.079
71029340|NCT03952143|141566260|NON_INFERIORITY|Noninferiority margin = 0.4% for HbA1c|LS Mean Difference|0.07||||0.321|TWO_SIDED|95.0|-0.07|0.21|||Mixed Models Analysis|||||0.21|-0.07|0.321
71029341|NCT03952143|141566261|SUPERIORITY||LS Mean Difference|-14.6|||<|0.001|TWO_SIDED|95.0|-21.9|-7.4|||ANCOVA|||||-7.4|-21.9|<0.001
71029342|NCT03952143|141566262|SUPERIORITY||LS Mean Difference|-21.8|||<|0.001|TWO_SIDED|95.0|-30.9|-12.6|||ANCOVA|||||-12.6|-30.9|<0.001
71029343|NCT03952143|141566263|SUPERIORITY||Relative rate|0.26|||||TWO_SIDED|95.0|0.02|2.86||||||||2.86|0.02|
71029344|NCT03952143|141566264|SUPERIORITY||Relative rate|0.9|||||TWO_SIDED|95.0|0.49|1.66||||||For ≤30 minutes post meal||1.66|0.49|
71029345|NCT03952143|141566264|SUPERIORITY||Relative rate|1.35|||||TWO_SIDED|95.0|0.79|2.31||||||For ≤ 1 hour post meal||2.31|0.79|
71029346|NCT03952143|141566264|SUPERIORITY||Relative rate|1.6|||||TWO_SIDED|95.0|1.06|2.42||||||For \>1 to ≤2 hours post meal||2.42|1.06|
71029347|NCT03952143|141566264|SUPERIORITY||Relative rate|1.53|||||TWO_SIDED|95.0|1.05|2.23||||||For ≤2 hours post meal||2.23|1.05|
71029348|NCT03952143|141566264|SUPERIORITY||Relative rate|0.97|||||TWO_SIDED|95.0|0.69|1.39||||||For \>2 to ≤4 hours post meal||1.39|0.69|
71029349|NCT03952143|141566264|SUPERIORITY||Relative rate|1.15|||||TWO_SIDED|95.0|0.84|1.57||||||For ≤4 hours post meal||1.57|0.84|
71029350|NCT03952143|141566265|SUPERIORITY||LS Mean Difference|-0.29|||||TWO_SIDED|95.0|-1.1|0.53||||||||0.53|-1.10|
71029351|NCT03952143|141566266|SUPERIORITY||LS Mean Difference|2.2|||||TWO_SIDED|95.0|-2.8|7.2||||||For Morning Premeal||7.2|-2.8|
71029352|NCT03952143|141566266|SUPERIORITY||LS Mean Difference|-5.3|||||TWO_SIDED|95.0|-12.6|2.0||||||For Morning 1-hour Postmeal||2.0|-12.6|
71029353|NCT03952143|141566266|SUPERIORITY||LS Mean Difference|-5.4|||||TWO_SIDED|95.0|-12.5|1.7||||||For Morning 2-hour Postmeal||1.7|-12.5|
71029354|NCT03952143|141566266|SUPERIORITY||LS Mean Difference|4.2|||||TWO_SIDED|95.0|-1.8|10.1||||||For Midday Premeal||10.1|-1.8|
71029355|NCT03952143|141566266|SUPERIORITY||LS Mean Difference|1.2|||||TWO_SIDED|95.0|-5.7|8.1||||||For Midday 1-hour Postmeal||8.1|-5.7|
71029356|NCT03952143|141566266|SUPERIORITY||LS Mean Difference|1.9|||||TWO_SIDED|95.0|-5.1|8.9||||||For Midday 2-hour Postmeal||8.9|-5.1|
71029357|NCT03952143|141566266|SUPERIORITY||LS Mean Difference|14.1|||||TWO_SIDED|95.0|7.6|20.6||||||For Evening Premeal||20.6|7.6|
71029358|NCT03952143|141566266|SUPERIORITY||LS Mean Difference|2.0|||||TWO_SIDED|95.0|-5.1|9.1||||||For Evening 1-hour Postmeal||9.1|-5.1|
71029359|NCT03952143|141566266|SUPERIORITY||LS Mean Difference|-0.2|||||TWO_SIDED|95.0|-7.3|6.8||||||For Evening 2-hour Postmeal||6.8|-7.3|
71029360|NCT03952143|141566266|SUPERIORITY||LS Mean Difference|1.7|||||TWO_SIDED|95.0|-4.7|8.1||||||For Bedtime||8.1|-4.7|
71029361|NCT03952143|141566267|SUPERIORITY||LS Mean Difference|2.8|||||TWO_SIDED|95.0|0.1|5.4||||||For Total Daily Insulin Dose||5.4|0.1|
71029362|NCT03952143|141566267|SUPERIORITY||LS Mean Difference|0.8|||||TWO_SIDED|95.0|0.0|1.5||||||For Daily Basal Insulin Dose||1.5|0.0|
71029363|NCT03952143|141566267|SUPERIORITY||LS Mean Difference|2.0|||||TWO_SIDED|95.0|-0.5|4.5||||||For Daily Prandial Insulin Dose||4.5|-0.5|
71029364|NCT03952143|141566268|SUPERIORITY||Odds Ratio (OR)|1.02||||0.924|TWO_SIDED|95.0|0.69|1.52|||Regression, Logistic|||For HbA1c \< 7%||1.52|0.69|0.924
71029365|NCT03952143|141566268|SUPERIORITY||Odds Ratio (OR)|0.98||||0.908|TWO_SIDED|95.0|0.64|1.49|||Regression, Logistic|||For HbA1c ≤6.5%||1.49|0.64|0.908
71029366|NCT01866319|141566269|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.58|||<|1e-05|TWO_SIDED|95.0|0.46|0.72|||Log Rank|||Statistical testing was stratified by line of therapy (1st vs. 2nd), programmed cell death ligand 1 (PD-L1) status (positive vs. negative) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1)||0.72|0.46|<0.00001
71029367|NCT01866319|141566269|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.58|||<|1e-05|TWO_SIDED|95.0|0.47|0.72|||Log Rank|||Statistical testing was stratified by line of therapy (1st vs. 2nd), programmed cell death ligand 1 (PD-L1) status (positive vs. negative) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1)||0.72|0.47|<0.00001
71029368|NCT01866319|141566269|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.75869|TWO_SIDED|95.0|0.77|1.21|||Log Rank|||Statistical testing was stratified by line of therapy (1st vs. 2nd), programmed cell death ligand 1 (PD-L1) status (positive vs. negative) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1)||1.21|0.77|0.75869
71029369|NCT01866319|141566270|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.00052|TWO_SIDED|95.0|0.47|0.83|||Regression, Cox|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1).||0.83|0.47|0.00052
70929886|NCT02938923|141357382|SUPERIORITY||Mean Difference (Final Values)|33.73||||0.867|TWO_SIDED|95.0|-365.4|432.86||Unadjusted p-value|Mixed Models Analysis|t (df, 102) = 0.17|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||432.860|-365.40|0.867
70929887|NCT02938923|141357382|SUPERIORITY||Mean Difference (Final Values)|665.75||||0.02|TWO_SIDED|95.0|105.68|1225.81||Unadjusted p-value|Mixed Models Analysis|t (df, 102) = 2.36|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||1225.81|105.68|0.020
71014852|NCT01054443|141536797|OTHER||LS Mean Difference|25544.0|||||TWO_SIDED|95.0|6202.8|44885.3|||||The difference of least squares means (LSMeans) between each of the lusutrombopag treatment groups and placebo was estimated after adjusting for the Baseline platelet count using analysis of covariance (ANCOVA).|||44885.3|6202.8|
71014853|NCT01054443|141536797|OTHER||LS Mean Difference|11801.3|||||TWO_SIDED|95.0|-8809.3|32411.9|||||The difference of least squares means (LSMeans) between each of the lusutrombopag treatment groups and placebo was estimated after adjusting for the Baseline platelet count using analysis of covariance (ANCOVA).|||32411.9|-8809.3|
71014854|NCT01054443|141536797|OTHER||LS Mean Difference|756.6|||||TWO_SIDED|95.0|-18794.3|20307.5|||||The difference of least squares means (LSMeans) between each of the lusutrombopag treatment groups and placebo was estimated after adjusting for the Baseline platelet count using analysis of covariance (ANCOVA).|||20307.5|-18794.3|
71014855|NCT01683331|141536994|SUPERIORITY||Odds Ratio (OR)|1.03||||0.87|TWO_SIDED|95.0|1.01|1.06|||Chi-squared|||||1.06|1.01|0.87
70850613|NCT02712047|141189438|OTHER||Mean Difference (Net)|12.87|||||TWO_SIDED|95.0|-9.3|35.05|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 8, AM|||35.05|-9.30|
71014856|NCT01683331|141536995|SUPERIORITY||Odds Ratio (OR)|1.3||||0.92|TWO_SIDED|95.0|1.2|2.8|||Chi-squared|||||2.8|1.2|0.92
71014857|NCT00526162|141537014|OTHER||percentage|0.0|||<|0.03|ONE_SIDED|97.0||||Using a confidence interval of 97%, the exact binomial upper confidence bound was 9.5% which is lower than the 10% set for the primary safety objective. Therefore, the actual p-value has not been calculated further.|One proportion binomial exact||The confidence interval was calculated based on 35 patients who completed 1-month follow-up at interim analysis.|||||<0.03
71014858|NCT05279807|141537019|SUPERIORITY||Mean difference pre vs post treatment|-13.5|||<|0.001|TWO_SIDED|95.0|-14.5|-12.5|||Paired Samples T-Test|||Primary endpoint, verified on the single cohort of patients who completed the monotherapy run-in period, is calculated as the mean difference in sitting diastolic blood pressure between Visit 2 (Week 0, Baseline Visit of the combination therapy) and Visit 4 (Week 8, End of Study Visit). This is not a comparison of two different arms, but a comparison of two measurements taken from the same patient treated with combination therapy (single arm paired pre- vs. post-combination therapy comparison)||-12.5|-14.5|< 0.001
71014859|NCT03985982|141537057|SUPERIORITY||||||<|0.001||||||This outcome measure is the first to be assessed in a hierarchical testing sequence using a one-sided alpha of 0.025.|Cochran-Mantel-Haenszel|||||||<0.001
71014860|NCT03985982|141537058|SUPERIORITY||||||<|0.001||||||The statistical significance is set to 0.025. This is the second test in a hierarchical testing sequence. Statistical significance will only be assessed if the previous test shows statistical significance at the 1-sided alpha level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for Modified Skindex-16 (GL-QoL) Emotional domain - Change from Baseline at Week 4||||<0.001
71014861|NCT03985982|141537058|SUPERIORITY||||||<|0.001||||||The statistical significance is set to 0.025. This is the third test in a hierarchical testing sequence. Statistical significance will only be assessed if the previous two tests show statistical significance at the alpha level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for Modified Skindex-16 (GL-QoL) Social Functioning domain - Change from Baseline at Week 4||||<0.001
71014862|NCT03985982|141537058|SUPERIORITY||||||<|0.001||||||The statistical significance is set to 0.025. This is the forth test in a hierarchical testing sequence. Statistical significance will only be assessed if the previous three tests show statistical significance at the 1-sided alpha level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for Modified Skindex-16 (GL-QoL) Overall score - Change from Baseline at Week 4.||||<0.001
71014863|NCT03985982|141537058|SUPERIORITY||||||<|0.001||||||The statistical significance is set to 0.025. This is the fifth test in a hierarchical testing sequence. Statistical significance will only be assessed if the previous four tests show statistical significance at the 1-sided alpha level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for FACE-Q Appraisal of Lines Between Eyebrows - Change from Baseline at Week 4||||<0.001
71014864|NCT03985982|141537058|SUPERIORITY||||||<|0.001||||||The statistical significance is set to 0.025. This is the sixth test in a hierarchical testing sequence. Statistical significance will only be assessed if the previous five tests show statistical significance at the 1-sided alpha level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for FACE-Q Age Appraisal VAS score||||<0.001
71014865|NCT05981365|141537106|OTHER||Ratio of Geometric LS Means|1.2629|||||TWO_SIDED|90.0|1.1673|1.3663||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.3663|1.1673|
71014866|NCT05981365|141537106|OTHER||Ratio of Geometric LS Means|1.1845|||||TWO_SIDED|95.0|1.0758|1.3042||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.3042|1.0758|
71014867|NCT05981365|141537107|OTHER||Ratio of Geometric LS Means|1.1929|||||TWO_SIDED|90.0|1.0215|1.393||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.3930|1.0215|
71014868|NCT05981365|141537108|OTHER||Ratio of Geometric LS Means|1.1311|||||TWO_SIDED|90.0|1.0496|1.2189||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.2189|1.0496|
70929888|NCT02938923|141357382|SUPERIORITY||Mean Difference (Final Values)|632.02||||0.029|TWO_SIDED|95.0|66.38|1197.66||Unadjusted p-value|Mixed Models Analysis|t (df, 102) = 2.22|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||1197.66|66.38|0.029
71014869|NCT05981365|141537109|OTHER||Ratio of Geometric LS Means|0.8228||||||90.0|0.6992|0.9683||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||0.9683|0.6992|
71014870|NCT05981365|141537110|OTHER||Ratio of Geometric LS Means|1.5738|||||TWO_SIDED|90.0|1.4523|1.7054||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.7054|1.4523|
71014871|NCT05981365|141537111|OTHER||Ratio of Geometric LS Means|1.1491|||||TWO_SIDED|90.0|1.0807|1.222||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.2220|1.0807|
71104493|NCT02908178|141716308|OTHER||Hazard Ratio (HR)|1.13||||0.861|TWO_SIDED|99.0|0.54|2.35||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between between use of sentinel lymph node biopsy (SLNB) and breast cancer specific mortality.||2.35|0.54|0.861
71014872|NCT05981365|141537111|OTHER||Ratio of Geometric LS Means|0.9494|||||TWO_SIDED|90.0|0.8759|1.0291||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.0291|0.8759|
71014873|NCT05981365|141537112|OTHER||Ratio of Geometric LS Means|1.3316|||||TWO_SIDED|90.0|1.2558|1.4121||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.4121|1.2558|
71014874|NCT05981365|141537113|OTHER||Ratio of Geometric LS Means|1.1282|||||TWO_SIDED|90.0|1.07|1.1896||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.1896|1.0700|
71014875|NCT05981365|141537114|OTHER||Ratio of Geometric LS Means|0.8047|||||TWO_SIDED|90.0|0.7173|0.9027||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||0.9027|0.7173|
71014876|NCT05981365|141537115|OTHER||Ratio of Geometric LS Means|2.0611|||||TWO_SIDED|90.0|1.8789|2.2609||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||2.2609|1.8789|
71014877|NCT05981365|141537116|OTHER||Ratio of Geometric LS Means|1.1374|||||TWO_SIDED|90.0|1.0672|1.2122||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.2122|1.0672|
71014878|NCT05981365|141537116|OTHER||Ratio of Geometric LS Means|0.9371|||||TWO_SIDED|90.0|0.8643|1.0162||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.0162|0.8643|
70850614|NCT02712047|141189438|OTHER||Mean Difference (Net)|7.5|||||TWO_SIDED|95.0|-14.67|29.68|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 8, PM|||29.68|-14.67|
71014879|NCT05981365|141537117|OTHER||Ratio of Geometric LS Means|1.2713|||||TWO_SIDED|90.0|1.1939|1.3538||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.3538|1.1939|
71014880|NCT05981365|141537118|OTHER||Ratio of Geometric LS Means|1.127|||||TWO_SIDED|90.0|1.0688|1.1883||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.1883|1.0688|
71014881|NCT05981365|141537119|OTHER||Ratio of Geometric LS Means|0.7973|||||TWO_SIDED|90.0|0.7039|0.9031||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||0.9031|0.7039|
71014882|NCT05981365|141537120|OTHER||Ratio of Geometric LS Means|2.026|||||TWO_SIDED|90.0|1.8496|2.2193||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||2.2193|1.8496|
71014883|NCT05981365|141537121|OTHER||Ratio of Geometric LS Means|0.7909|||||TWO_SIDED|90.0|0.716|0.8737||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||0.8737|0.7160|
71014884|NCT05981365|141537122|OTHER||Ratio of Geometric LS Means|1.0831|||||TWO_SIDED|90.0|0.9723|1.2065||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.2065|0.9723|
71014885|NCT05981365|141537123|OTHER||Ratio of Geometric LS Means|1.3138|||||TWO_SIDED|90.0|1.1871|1.4541||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.4541|1.1871|
71014886|NCT05981365|141537124|OTHER||Ratio of Geometric LS Means|0.7958|||||TWO_SIDED|90.0|0.742|0.8534||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||0.8534|0.7420|
71014887|NCT05981365|141537125|OTHER||Ratio of Geometric LS Means|1.0322|||||TWO_SIDED|90.0|0.9531|1.1179||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.1179|0.9531|
71014888|NCT05981365|141537126|OTHER||Ratio of Geometric LS Means|1.1975|||||TWO_SIDED|90.0|1.0972|1.3069||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.3069|1.0972|
71014889|NCT05981365|141537127|OTHER||Ratio of Geometric LS Means|0.8018|||||TWO_SIDED|90.0|0.7472|0.8604||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||0.8604|0.7472|
71014890|NCT05981365|141537128|OTHER||Ratio of Geometric LS Means|1.063|||||TWO_SIDED|90.0|0.9888|1.1427||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.1427|0.9888|
71014891|NCT05981365|141537129|OTHER||Ratio of Geometric LS Means|1.2197|||||TWO_SIDED|90.0|1.1114|1.3385||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.3385|1.1114|
71014892|NCT02203305|141537186|SUPERIORITY||||||<|0.001||||||Percent correct converted to rationalized arcsine units (RAU) prior to analysis.|Mixed Models Analysis|Main effects: interval (p\<0.001) and condition (p\<0.001). Interaction: Interval and condition (p\<0.001).||Recorded 50-word consonant-nucleus-consonant (CNC) words were evaluated for the poorer hearing ear 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction. Percent correct converted to RAU.||||<0.001
71014893|NCT02203305|141537186|SUPERIORITY||||||<|0.001||||||Percent correct converted to rationalized arcsine units (RAU) prior to analysis.|Mixed Models Analysis|Main effects: interval (p\<0.001) and condition (p\<0.001). Interaction: interval and condition (p\<0.001).||Recorded 50-word CNC words were evaluated for the poorer hearing ear 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction. Percent correct converted to RAU.||||<0.001
70850615|NCT02712047|141189438|OTHER||Mean Difference (Net)|3.32|||||TWO_SIDED|95.0|-19.11|25.74|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 9, AM|||25.74|-19.11|
71014894|NCT02203305|141537186|SUPERIORITY||||||<|0.001||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.||Recorded 50-word CNC words were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||<0.001
71014895|NCT02203305|141537186|SUPERIORITY||||||<|0.001||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|||Recorded 50-word CNC words were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||<0.001
71014896|NCT02203305|141537186|SUPERIORITY||||||<|0.429||||||A logit transformation was applied to proportion correct data prior to analysis.|Mixed Models Analysis|Main effects: interval (p\<0.001) and group (p=0.429). Interaction: group and interval (p=0.387).||Comparison of word recognition between groups (UHL/SSD and AHL) over the post-activation intervals (1, 3, 6, 9, and 12 months).||||<0.429
71014897|NCT02203305|141537187|SUPERIORITY||||||<|0.019||||||The Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p=0.19) and condition (p\<0.001). Interaction: interval and condition (p\<0.019).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.019
71014898|NCT02203305|141537187|SUPERIORITY||||||<|0.012||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p=0.012) and condition (p\<0.001). Interaction: interval and condition (p=0.004).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.012
70929889|NCT02938923|141357383|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.946|TWO_SIDED|95.0|-19.61|21.01||Unadjusted p-value|Mixed Models Analysis|t (df, 110) = 0.07|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||21.01|-19.61|0.946
71014899|NCT02203305|141537187|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. A repeated-measures ANOVA evaluated the effect of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||<0.001
71029370|NCT01866319|141566270|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69||||0.00358|TWO_SIDED|95.0|0.52|0.9|||Regression, Cox|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1).||0.90|0.52|0.00358
70929890|NCT02938923|141357383|SUPERIORITY||Mean Difference (Final Values)|24.44||||0.094|TWO_SIDED|95.0|-4.25|53.13||Unadjusted p-value|Mixed Models Analysis|t (df, 110) = 1.69|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||53.13|-4.25|0.094
71029371|NCT01866319|141566270|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.51319||95.0|0.67|1.22|||Regression, Cox|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1).||1.22|0.67|0.51319
71029372|NCT01866319|141566271|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|16.1||||0.00013|TWO_SIDED|95.0|7.8|24.5|||Miettinen & Nurmimen|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1)||24.5|7.8|0.00013
71029373|NCT01866319|141566271|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|17.2||||2e-05|TWO_SIDED|95.0|9.5|25.6|||Miettinen & Nurmimen|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1)||25.6|9.5|0.00002
71029374|NCT01866319|141566271|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-1.1||||0.82636||95.0|-10.6|8.6|||Miettinen & Nurmimen|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1)||8.6|-10.6|0.82636
71029375|NCT04421508|141566274|SUPERIORITY||Odds Ratio (OR)|0.36||||0.6316|TWO_SIDED|95.0|||||Regression, Logistic|||||||0.6316
71029376|NCT04421508|141566274|SUPERIORITY||Odds Ratio (OR)|1.502||||0.4127|TWO_SIDED|95.0|0.567|3.977||Odds ratio, 95% CI and p-value are from a logistic regression model modelling the response using the covariates treatment, age, number of co-morbidities and baseline oxygem level|Regression, Logistic|||||3.977|0.567|0.4127
71029377|NCT04421508|141566282|SUPERIORITY|||||||0.6635|||||||Chi-squared|||||||0.6635
71029378|NCT03980483|141566284|SUPERIORITY||Odds Ratio (OR)|1.62||||0.0023|TWO_SIDED|0.95|1.19|2.21|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 90mg dose of GSK3196165 and placebo in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 90mg dose of GSK3196165 differs from placebo in the proportion of participants achieving ACR20 response at Week 12.||2.21|1.19|0.0023
71029379|NCT03980483|141566284|SUPERIORITY||Odds Ratio (OR)|1.39||||0.0362|TWO_SIDED|0.95|1.02|1.89|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 150mg dose of GSK3196165 and placebo in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 150mg dose of GSK3196165 differs from placebo in the proportion of participants achieving ACR20 response at Week 12.||1.89|1.02|0.0362
71029380|NCT03980483|141566284|SUPERIORITY||Odds Ratio (OR)|2.34|||<|0.0001|TWO_SIDED|0.95|1.62|3.37|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 05mg dose of Tofacitinib and placebo in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 05mg dose of Tofacitinib differs from placebo in the proportion of participants achieving ACR20 response at Week 12.||3.37|1.62|<0.0001
71029381|NCT03980483|141566284|SUPERIORITY||Odds Ratio (OR)|0.69||||0.023|TWO_SIDED|0.95|0.5|0.95|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 90mg dose of GSK3196165 and 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 90mg dose of GSK3196165 differs from 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12.||0.95|0.50|0.0230
71029382|NCT03980483|141566284|SUPERIORITY||Odds Ratio (OR)|0.59||||0.0013|TWO_SIDED|0.95|0.43|0.82|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 150mg dose of GSK3196165 and 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 150mg dose of GSK3196165 differs from 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12.||0.82|0.43|0.0013
71029383|NCT03980483|141566287|NON_INFERIORITY|Non-inferiority over tofacitinib on ACR20 was concluded if the lower limit of the multiplicity corrected 97.5 % Confidence Interval (CI) in the difference in proportions (GSK3196165 minus tofacitinib) was greater than -12%|Mean Difference (Final Values)|-10.4|||||TWO_SIDED|0.975|-18.6|-2.3|||Regression, Logistic|Difference in proportion and 97.5% CI are generated from logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||||-2.3|-18.6|
70929891|NCT02938923|141357383|SUPERIORITY||Mean Difference (Final Values)|23.74||||0.107|TWO_SIDED|95.0|-5.19|52.67||Unadjusted p-value|Mixed Models Analysis|t (df, 110) = 1.63|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||52.67|-5.19|0.107
71014900|NCT02203305|141537187|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. A repeated-measures ANOVA evaluated the effects of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||<0.001
71014901|NCT02203305|141537187|OTHER|correlation|bivariate pearson correlation|0.42|||=|0.033|TWO_SIDED||||||bivariate pearson correlation|||Association of age at implantation and sound source localization (RMS) at the 12-month interval with the cochlear implant, analyzed with a Bivariate Pearson correlation (one-tailed).||||=0.033
71014902|NCT02203305|141537187|SUPERIORITY||||||<|0.249||||||There were significant main effects of group (p\<0.001) and interval (p\<0.001). There was a non-significant interaction between group and interval (p=0.249).|Mixed Models Analysis|Main effects: group (p\<0.001) and interval (p\<0.001). Interaction: group and interval (p=0.249).||Comparison of sound source localization between groups (UHL/SSD and AHL) over the post-activation intervals (1, 3, 6, 9, and 12 months).||||<0.249
71014903|NCT02203305|141537188|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Responses on the Speech, Spatial, \& Qualities of hearing scale (SSQ) as measured with the total score were compared over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).||||<0.001
71014904|NCT02203305|141537188|SUPERIORITY||||||=|0.056||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Responses on the SSQ as measured with the total score were compared over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).||||=0.056
71014905|NCT02203305|141537188|SUPERIORITY||||||<|0.448||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p\<0.001) and subscale (p\<0.001). Interaction: interval and subscale (p=0.488).||Responses on the SSQ over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). Subscales include: speech, spatial, and qualities of hearing. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.448
71014906|NCT02203305|141537188|SUPERIORITY||||||<|0.299||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: subscale (p\<0.001) and interval (p=0.072). Interaction: subscale and interval (p=0.299).||Responses on the SSQ over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). Subscales include: speech, spatial, and qualities of hearing. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.299
71014907|NCT02203305|141537188|SUPERIORITY||||||<|0.018||||||There were significant main effects of interval (p\<0.001) and pragmatic subscale (p\<0.001), and their interaction (p\<0.018).|Mixed Models Analysis|Main effects: interval (p\<0.001) and pragmatic subscale (p\<0.001). Interaction: interval and pragmatic subscale (p\<0.018).||Responses on the SSQ Speech pragmatic subscale over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.018
71014908|NCT02203305|141537188|SUPERIORITY||||||<|0.767|||||||Mixed Models Analysis|Main effects: interval (p\<0.001) and pragmatic subscale (p=0.767). Interaction: interval and pragmatic subscale (p=0.542).||Responses on the SSQ Spatial pragmatic subscale over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.767
71014909|NCT02203305|141537188|SUPERIORITY||||||<|0.242|||||||Mixed Models Analysis|Main effects: interval (p=0.003) and pragmatic subscale (p\<0.001). Interaction: interval and pragmatic subscale (p=0.242).||Responses on the SSQ Qualities of Hearing pragmatic subscale over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.242
71014910|NCT02203305|141537188|OTHER|Bivariate pearson correlation||||||0.37|||||||bivariate pearson correlation|||Association of subjective benefit (Speech Subscale) at the preoperative interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||0.370
70929892|NCT02938923|141357383|SUPERIORITY||Mean Difference (Final Values)|4.81||||0.627|TWO_SIDED|95.0|-14.68|24.3||Unadjusted p-value|Mixed Models Analysis|t (df, 189) = 0.49|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||24.30|-14.68|0.627
71014911|NCT02203305|141537188|OTHER|bivariate pearson correlation|||||=|0.865||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Speech Subscale) at the preoperative interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.865
71014912|NCT02203305|141537188|OTHER|bivariate pearson correlation|bivariate pearson correlation|0.6|||=|0.005|TWO_SIDED|||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Speech Subscale) at the 12-month interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.005
71014913|NCT02203305|141537188|OTHER|bivariate pearson correlation|bivariate pearson correlation|0.67|||=|0.006|TWO_SIDED|||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Speech Subscale) at the 12-month interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.006
71014914|NCT02203305|141537188|OTHER|bivariate pearson correlation|bivariate pearson correlation|-0.33|||=|0.152|TWO_SIDED||||||bivariate pearson correlation|||Association of subjective benefit (Spatial Subscale) at the preoperative interval and sound source localization (RMS error).||||=0.152
71014915|NCT02203305|141537188|OTHER|bivariate pearson correlation|||||=|0.761|||||||bivariate pearson correlation|||Association of subjective benefit (Spatial Subscale) at the preoperative interval and sound source localization (RMS error).||||=0.761
71014916|NCT02203305|141537188|OTHER|bivariate pearson correlation|||||=|0.315|||||||bivariate pearson correlation|||Association of subjective benefit (Spatial Subscale) at the 12-month interval and sound source localization (RMS error).||||=0.315
71014917|NCT02203305|141537188|OTHER|bivariate pearson correlation|||||=|0.666|||||||bivariate pearson correlation|||Association of subjective benefit (Spatial Subscale) at the 12-month interval and sound source localization (RMS error).||||=0.666
71014918|NCT02203305|141537188|SUPERIORITY||||||>|0.175|||||||Mixed Models Analysis|Main effects: cohort (p=0.912), interval (p=0.463), and subscale (p=0.483). Interactions: 2-way or 3-way (p\>0.175).||Comparison of subjective benefit between groups (UHL/SSD and AHL) on the speech, spatial, and qualities of hearing subscales during the post-activation intervals (1, 3, 6, 9, and 12 months).||||>0.175
71014919|NCT02203305|141537189|SUPERIORITY||||||<|0.161||||||"Significant effect of interval (p=0.046) and of condition (p\<0.001) and a non-significant interaction (p=0.161).~Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis."|Mixed Models Analysis|Main effects: interval (p=0.046) and condition (p\<0.001). Interaction: interval and condition (p=0.161).||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.161
71014920|NCT02203305|141537189|SUPERIORITY||||||>|0.107||||||"Significant effect of condition (p\<0.001) and the interaction (p\<0.001). Non-significant effect of interval (p=0.107).~Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis."|Mixed Models Analysis|Main effects: condition (p\<0.001) and interval p=0.107). Interaction of condition and interval (p\<0.001).||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||>0.107
71014921|NCT02203305|141537189|SUPERIORITY||||||<|0.001||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|||Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||<0.001
70850616|NCT02712047|141189438|OTHER||Mean Difference (Net)|3.83|||||TWO_SIDED|95.0|-18.34|26.0|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 9, PM|||26.00|-18.34|
71014922|NCT02203305|141537189|SUPERIORITY||||||<|0.001||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|||Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||<0.001
71014923|NCT02203305|141537189|OTHER|bivariate pearson correlation|||||=|0.58||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of age at implantation and speech recognition in noise at the 12-month interval with the cochlear implant, analyzed with a Bivariate Pearson correlation.||||=0.580
71029384|NCT03980483|141566287|NON_INFERIORITY|Non-inferiority over tofacitinib on ACR20 was concluded if the lower limit of the multiplicity corrected 97.5% CI in the difference in proportions (GSK3196165 minus tofacitinib) was greater than -12%|Mean Difference (Final Values)|-13.0|||||TWO_SIDED|0.975|-21.2|-4.8|||Regression, Logistic|Difference in proportion and 97.5% CI are generated from logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||||-4.8|-21.2|
71029385|NCT03249584|141566610|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||An improvement from baseline to 3 months post radiofrequency ablation in worst pain score will be demonstrated with an outcome which is statistically lower than zero.||||<0.0001
71029386|NCT00659607|141566614|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test for paired observations|||||||<0.0001
71029387|NCT00659607|141566615|SUPERIORITY_OR_OTHER|||||||0.2669|||||||Chi-squared|||||||0.2669
71029388|NCT00659607|141566616|SUPERIORITY_OR_OTHER|||||||0.9674|||||||Chi-squared|||||||0.9674
71029389|NCT00659607|141566617|SUPERIORITY_OR_OTHER|||||||0.9207|||||||Chi-squared|||||||0.9207
71029390|NCT00659607|141566618|SUPERIORITY_OR_OTHER|||||||0.8249|||||||Fisher Exact|||||||0.8249
71029391|NCT00659607|141566619|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test for paired observations|||||||<0.0001
71029392|NCT00659607|141566621|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.0003|TWO_SIDED|95.0|1.121|4.151|||Chi-squared||The estimation of Odds Ratio and 95% Confidence Interval based on the logistic regression analysis|||4.151|1.121|0.0003
71029393|NCT00659607|141566622|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.3|||<|0.0001|TWO_SIDED|95.0|1.642|6.776|||Chi-squared||The Estimation of Odds Ratio and 95% Confidence Interval based the logistic regression analysis|||6.776|1.642|<0.0001
71029394|NCT00659607|141566623|SUPERIORITY_OR_OTHER|||||||0.0075|||||||Chi-squared|||||||0.0075
71029395|NCT00659607|141566624|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Chi-squared|||||||0.0007
71029396|NCT00659607|141566625|SUPERIORITY_OR_OTHER|||||||0.0393|||||||Chi-squared|||||||0.0393
71029397|NCT00659607|141566626|SUPERIORITY_OR_OTHER|||||||0.0245|||||||Chi-squared|||||||0.0245
70850617|NCT02712047|141189438|OTHER||Mean Difference (Net)|11.36|||||TWO_SIDED|95.0|-11.11|33.82|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 10, AM|||33.82|-11.11|
70929893|NCT02938923|141357383|SUPERIORITY||Mean Difference (Final Values)|24.91||||0.072|TWO_SIDED|95.0|-2.2|52.01||Unadjusted p-value|Mixed Models Analysis|t (df, 189) = 1.81|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||52.01|-2.20|0.072
70929894|NCT02938923|141357383|SUPERIORITY||Mean Difference (Final Values)|20.1||||0.149|TWO_SIDED|95.0|-7.29|47.49||Unadjusted p-value|Mixed Models Analysis|t (df, 189) = 1.45|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||47.49|-7.29|0.149
70929895|NCT02938923|141357383|SUPERIORITY||Mean Difference (Final Values)|-1.38||||0.849|TWO_SIDED|95.0|-15.71|12.95||Unadjusted p-value|Mixed Models Analysis|t (df, 110) = -0.19|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||12.95|-15.71|0.849
70929896|NCT02938923|141357383|SUPERIORITY||Mean Difference (Final Values)|15.47||||0.134|TWO_SIDED|95.0|-4.83|35.78||Unadjusted p-value|Mixed Models Analysis|(df, 110) = 1.15|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||35.78|-4.83|0.134
71104494|NCT02908178|141716309|OTHER||Hazard Ratio (HR)|1.03||||0.603|TWO_SIDED|99.0|0.71|1.51||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and ipsilateral invasive breast cancer occurrence for the Aim 2 matched cohort.||1.51|0.71|0.603
70929897|NCT02938923|141357383|SUPERIORITY||Mean Difference (Final Values)|16.86||||0.107|TWO_SIDED|95.0|-3.68|37.39||Unadjusted p-value|Mixed Models Analysis|t (df, 110) = 1.63|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||37.39|-3.68|0.107
71014924|NCT02203305|141537189|SUPERIORITY||||||<|0.743||||||A logit transformation was applied to proportion correct data prior to analysis.|Mixed Models Analysis|Effects: SNR (p=0.026) \& masker condition (p\<0.001). Interactions: cohort \& condition (p\<0.001), interval \& condition (p=0.015). Others (p\>0.140).||Comparison of speech recognition between groups (UHL/SSD and AHL) for the three masker configurations (noise towards the better hearing ear, noise towards the poorer hearing ear, and noise from the front) and signal-to-noise ratio (SNR; 0, 5, or 10 dB SNR) over the post-activation intervals (1, 3, 6, 9, and 12 months).||||<0.743
71014925|NCT02203305|141537189|OTHER|pearson correlation|||||=|0.036||||||Percent correct converted to rationalized arcsine units (RAU) prior to analysis.|bivariate pearson correlation|||Association of word recognition and speech recognition in noise, analyzed with a Bivariate Pearson correlation. Scores were averaged between 3 and 12 months post-activation as an estimate of asymptotic performance.||||=0.036
71014926|NCT02203305|141537190|SUPERIORITY||||||<|0.183||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effect: interval (p=0.183) and condition (p=0.012). Interaction: interval and condition (p=0.081).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Variable error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.183
71014927|NCT02203305|141537190|SUPERIORITY||||||<|0.196||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effect: interval (p=0.010) and condition (p=0.100). Interaction: interval and condition (p=0.196).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Variable error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.196
70929898|NCT02938923|141357383|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.973|TWO_SIDED|95.0|-13.64|13.17||Unadjusted p-value|Mixed Models Analysis|t (df, 189) = -0.03|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||13.17|-13.64|0.973
70929899|NCT02938923|141357383|SUPERIORITY||Mean Difference (Final Values)|14.49||||0.135|TWO_SIDED|95.0|-4.56|33.54||Unadjusted p-value|Mixed Models Analysis|t (df, 189) = 1.50|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||33.54|-4.56|0.135
70929900|NCT02938923|141357383|SUPERIORITY||Mean Difference (Final Values)|14.72||||0.134|TWO_SIDED|95.0|-4.55|34.0||Unadjusted p-value|Mixed Models Analysis|t (df, 189) = 1.51|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||34.00|-4.55|0.134
70929901|NCT02938923|141357384|SUPERIORITY||Mean Difference (Final Values)|1.21||||0.125|TWO_SIDED|95.0|-0.34|2.76||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 1.55|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||2.76|-0.34|0.125
71049254|NCT02504671|141606186|OTHER||Mean Difference (Net)|-0.3||||0.071|TWO_SIDED|95.0|-0.62|0.03||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1|||0.03|-0.62|0.071
71104495|NCT02908178|141716310|OTHER||Hazard Ratio (HR)|1.17||||0.62|TWO_SIDED|99.0|0.81|1.69||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and treated recurrence in the Aim 2 matched cohort.||1.69|0.81|0.620
70929902|NCT02938923|141357384|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.758|TWO_SIDED|95.0|-1.9|2.61||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.31|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||2.61|-1.90|0.758
70929903|NCT02938923|141357384|SUPERIORITY||Mean Difference (Final Values)|-0.86||||0.455|TWO_SIDED|95.0|-3.12|1.41||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.75|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||1.41|-3.12|0.455
70929904|NCT02938923|141357384|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.229|TWO_SIDED|95.0|-0.72|3.0||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 1.21|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||3.00|-0.72|0.229
70929905|NCT02938923|141357384|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.647|TWO_SIDED|95.0|-1.97|3.16||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 0.46|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||3.16|-1.97|0.647
70929906|NCT02938923|141357384|SUPERIORITY||Mean Difference (Final Values)|-0.54||||0.68|TWO_SIDED|95.0|-3.12|2.04||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = -0.41|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||2.04|-3.12|0.680
70929907|NCT02938923|141357384|SUPERIORITY||Mean Difference (Final Values)|1.48||||0.052|TWO_SIDED|95.0|-0.02|2.97||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 1.96|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||2.97|-0.02|0.052
71014928|NCT02203305|141537190|SUPERIORITY|||||||0.056||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Variable error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. A repeated-measures ANOVA evaluated the effect of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||0.056
71014929|NCT02203305|141537190|SUPERIORITY||||||=|0.21||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Variable error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. A repeated-measures ANOVA evaluated the effects of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||=0.210
70929908|NCT02938923|141357384|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.754|TWO_SIDED|95.0|-1.79|2.46||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.31|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||2.46|-1.79|0.754
70929909|NCT02938923|141357384|SUPERIORITY||Mean Difference (Final Values)|-1.14||||0.294|TWO_SIDED|95.0|-3.28|1.0||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -1.06|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||1.00|-3.28|0.294
70929910|NCT02938923|141357384|SUPERIORITY||Mean Difference (Final Values)|1.46||||0.031|TWO_SIDED|95.0|0.13|2.78||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 2.17|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||2.78|0.13|0.031
70929911|NCT02938923|141357384|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.752|TWO_SIDED|95.0|-1.56|2.16||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 0.32|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||2.16|-1.56|0.752
70929912|NCT02938923|141357384|SUPERIORITY||Mean Difference (Final Values)|-1.16||||0.223|TWO_SIDED|95.0|-3.03|0.71||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = -1.22|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||0.71|-3.03|0.223
71014930|NCT02203305|141537191|SUPERIORITY||||||<|0.071||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p\<0.071) and condition (p\<0.001). Interaction: interval and condition (p\<0.051)||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.071
71014931|NCT02203305|141537191|SUPERIORITY||||||<|0.109||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p=0.109) and condition (p\<0.001). Interaction: interval and condition (p=0.052).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.109
70929913|NCT02938923|141357385|SUPERIORITY||Mean Difference (Final Values)|0.85||||0.006|TWO_SIDED|95.0|0.24|1.46||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 2.78|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||1.46|0.24|0.006
70929914|NCT02938923|141357385|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.863|TWO_SIDED|95.0|-0.81|0.97||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.17|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.97|-0.81|0.863
70929915|NCT02938923|141357385|SUPERIORITY||Mean Difference (Final Values)|-0.77||||0.091|TWO_SIDED|95.0|-1.67|0.12||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -1.71|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.12|-1.67|0.091
70929916|NCT02938923|141357385|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.009|TWO_SIDED|95.0|0.21|1.44||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 2.65|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||1.44|0.21|0.009
71104496|NCT04716894|141716311|OTHER||adjusted geometric mean (gMean) ratio(%)|197.77|||||TWO_SIDED|90.0|187.9|208.15|||||Ratio (%) = T/R\*100. Intra-individual geometric coefficient of variation (gCV) = 7.0.|Relative bioavailability. Model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data were log-transformed (natural logarithm) prior to fitting the ANOVA model. The effect 'subjects' was considered as random effect, whereas 'treatment' was considered as fixed effect.||208.15|187.90|
71104497|NCT04716894|141716312|OTHER||adjusted geometric mean (gMean) ratio(%)|143.38|||||TWO_SIDED|90.0|121.92|168.6|||||Ratio (%) = T/R\*100. Intra-individual geometric coefficient of variation (gCV) = 22.1.|Relative bioavailability. Model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data were log-transformed (natural logarithm) prior to fitting the ANOVA model. The effect 'subjects' was considered as random effect, whereas 'treatment' was considered as fixed effect.||168.60|121.92|
71104498|NCT04716894|141716313|OTHER||adjusted geometric mean (gMean) ratio(%)|201.64|||||TWO_SIDED|90.0|192.23|211.52|||||Ratio (%) = T/R\*100. Intra-individual geometric coefficient of variation (gCV) = 6.5.|Relative bioavailability. Model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data were log-transformed (natural logarithm) prior to fitting the ANOVA model. The effect 'subjects' was considered as random effect, whereas 'treatment' was considered as fixed effect.||211.52|192.23|
71104499|NCT03773484|141716314|OTHER||Slope|-0.008|STANDARD_ERROR_OF_MEAN|0.011||0.43|TWO_SIDED|95.0|-0.03|0.01|||Mixed Models Analysis|||Pre post comparison for Opioid Naïve patients||0.01|-0.03|0.43
71104500|NCT03773484|141716314|OTHER||Slope|-0.019|STANDARD_ERROR_OF_MEAN|0.016||0.24|TWO_SIDED|95.0|-0.051|0.013|||Mixed Models Analysis|||Pre-post comparison for at-risk for long term use patients||0.013|-0.051|0.24
71104501|NCT03211416|141716342|SUPERIORITY||Response Rate|0.296|||||TWO_SIDED|95.0|0.151|0.483||||||||0.483|0.151|
71104502|NCT03211416|141716345|SUPERIORITY|||||||0.4||||||Significance level of 0.05.|Two-sided, one-sample t-test|||The null hypothesis is that the mean ratio of T effect cells (post / pre) is equal to 1 (no change).||||0.40
71104503|NCT02302222|141716347|SUPERIORITY||Risk Difference (RD)|0.113||||0.1981|TWO_SIDED|95.0|-0.016|0.243|||Fisher Exact|||||0.243|-0.016|0.1981
71104504|NCT03781570|141716371|SUPERIORITY||Mean Difference (Final Values)|-0.0544|STANDARD_ERROR_OF_MEAN|0.00517|<|0.001|TWO_SIDED|95.0|-0.0648|-0.0441|||Mixed Models Analysis|Satterthwaite's method was used to estimate degrees of freedom for the mixed effects model.||Comparing placebo vs. control for thermal pain ratings with mixed effects models controlling for the stimulus intensity and the familial structure of the data.||-0.0441|-0.0648|<0.001
70929917|NCT02938923|141357385|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.778|TWO_SIDED|95.0|-0.76|1.02||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 0.28|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||1.02|-0.76|0.778
70929918|NCT02938923|141357385|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.124|TWO_SIDED|95.0|-1.59|0.19||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = -1.55|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.19|-1.59|0.124
71104505|NCT01107496|141716373|SUPERIORITY||Median Difference (Net)|6.0||||0.0414|TWO_SIDED|95.0|1.0|12.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 6 data.||12.00|1.00|0.0414
71104506|NCT01107496|141716374|SUPERIORITY||Median Difference (Net)|3.0||||0.0803|TWO_SIDED|95.0|0.0|7.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 1 data.||7.00|0.00|0.0803
71104507|NCT01107496|141716375|SUPERIORITY||Median Difference (Net)|0.0||||0.5308|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||This analysis pertains to Week 1 data.||1.00|-1.00|0.5308
71104508|NCT01107496|141716375|SUPERIORITY||Median Difference (Net)|-1.0||||0.2032|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis pertains to Week 2 data.||0.00|-2.00|0.2032
71104509|NCT01107496|141716375|SUPERIORITY||Median Difference (Net)|-1.0||||0.0677|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis pertains to Week 3 data.||0.00|-2.00|0.0677
71104510|NCT01107496|141716375|SUPERIORITY||Median Difference (Net)|-1.0||||0.0743|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis pertains to Week 4 data.||0.00|-2.00|0.0743
71104511|NCT01107496|141716375|SUPERIORITY||Median Difference (Net)|-1.0||||0.0437|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis pertains to Week 5 data.||0.00|-2.00|0.0437
70850618|NCT02712047|141189438|OTHER||Mean Difference (Net)|27.73|||||TWO_SIDED|95.0|5.43|50.03|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 10, PM|||50.03|5.43|
71104512|NCT01107496|141716375|SUPERIORITY||Median Difference (Net)|-1.0||||0.1209|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 6 data.||0.00|-2.00|0.1209
71104513|NCT01107496|141716376|SUPERIORITY||Median Difference (Net)|1.0||||0.6022|TWO_SIDED|95.0|-4.0|6.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 2 data.||6.00|-4.00|0.6022
71104514|NCT01107496|141716376|SUPERIORITY||Median Difference (Net)|-4.0||||0.0794|TWO_SIDED|95.0|-10.0|1.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 3 data.||1.00|-10.0|0.0794
70929919|NCT02938923|141357385|SUPERIORITY||Mean Difference (Final Values)|0.69||||0.027|TWO_SIDED|95.0|0.08|1.31||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 2.24|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||1.31|0.08|0.027
70929920|NCT02938923|141357385|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.833|TWO_SIDED|95.0|-0.97|0.78||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.21|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.78|-0.97|0.833
70929921|NCT02938923|141357385|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.08|TWO_SIDED|95.0|-1.67|0.1||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -1.77|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.10|-1.67|0.080
70929922|NCT02938923|141357385|SUPERIORITY||Mean Difference (Final Values)|0.67||||0.014|TWO_SIDED|95.0|0.14|1.21||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 2.49|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||1.21|0.14|0.014
70929923|NCT02938923|141357385|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.834|TWO_SIDED|95.0|-0.84|0.68||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = -0.21|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.68|-0.84|0.834
71014932|NCT02203305|141537191|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. A repeated-measures ANOVA evaluated the effect of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||<0.001
71014933|NCT02203305|141537191|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. A repeated-measures ANOVA evaluated the effects of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||<0.001
71049255|NCT02504671|141606186|OTHER||Mean Difference (Net)|-0.37||||0.022|TWO_SIDED|95.0|-0.69|-0.05||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1|||-0.05|-0.69|0.022
71014934|NCT02203305|141537192|SUPERIORITY||||||<|0.024||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p=0.018) and condition (p\<0.001). Interaction: interval and condition (p=0.024).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.024
71014935|NCT02203305|141537192|SUPERIORITY||||||<|0.219|||||||Mixed Models Analysis|Main effects: interval (p=0.187) and condition (p\<0.001). Interaction: interval and condition (p=0.219).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.219
71049256|NCT02504671|141606186|OTHER||Mean Difference (Net)|-0.28||||0.16|TWO_SIDED|95.0|-0.67|0.11||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2|||0.11|-0.67|0.160
70929924|NCT02938923|141357385|SUPERIORITY||Mean Difference (Final Values)|-0.75||||0.054|TWO_SIDED|95.0|-1.52|0.01||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = -1.94|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.01|-1.52|0.054
70929925|NCT02938923|141357386|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.326|TWO_SIDED|95.0|-0.25|0.74||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.99|Difference between the BADL changes (EX+T - EX+P)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.74|-0.25|0.326
70929926|NCT02938923|141357386|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.587|TWO_SIDED|95.0|-0.87|0.49||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.54|Difference between the BADL changes (EX+T - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.49|-0.87|0.587
70929927|NCT02938923|141357386|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.213|TWO_SIDED|95.0|-1.12|0.25||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -1.25|Difference between the BADL changes (EX+P - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.25|-1.12|0.213
70929928|NCT02938923|141357386|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.41|TWO_SIDED|95.0|-0.32|0.78||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.83|Difference between the BADL changes (EX+T - EX+P)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||0.78|-0.32|0.410
70929929|NCT02938923|141357386|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.527|TWO_SIDED|95.0|-0.99|0.51||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.63|Difference between the BADL changes (EX+T - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||0.51|-0.99|0.527
70929930|NCT02938923|141357386|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.219|TWO_SIDED|95.0|-1.23|0.28||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -1.23|Difference between the BADL changes (EX+P - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||0.28|-1.23|0.219
70929931|NCT02938923|141357386|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.355|TWO_SIDED|95.0|-0.25|0.69||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.93|Difference between the BADL changes (EX+T - EX+P)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.69|-0.25|0.355
70929932|NCT02938923|141357386|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.554|TWO_SIDED|95.0|-0.88|0.47||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.59|Difference between the BADL changes (EX+T - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.47|-0.88|0.554
71014936|NCT02203305|141537192|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response. A repeated-measures ANOVA evaluated the effect of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||<0.001
71014937|NCT02203305|141537192|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response. A repeated-measures ANOVA evaluated the effects of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||<0.001
71014938|NCT02203305|141537193|SUPERIORITY||||||=|0.011||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Responses on the Abbreviated Profile of Hearing Aid Benefit (APHAB) as measured with the global score were compared over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).||||=0.011
70929933|NCT02938923|141357386|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.219|TWO_SIDED|95.0|-1.1|0.26||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -1.24|Difference between the BADL changes (EX+P - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.26|-1.10|0.219
70929934|NCT02938923|141357386|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.345|TWO_SIDED|95.0|-0.24|0.68||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.95|Difference between the BADL changes (EX+T - EX+P)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||0.68|-0.24|0.345
71014939|NCT02203305|141537193|SUPERIORITY||||||=|0.264||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is calculated from the responses on the ease of communication, reverberation, and effectiveness in background noise subscales. Responses were compared to responses over the post-activation period (1, 3, 6, 9, and 12 months) with the cochlear implant using a repeated-measures ANOVA.||||=0.264
71014940|NCT02203305|141537193|SUPERIORITY||||||<|0.023||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p=0.005) and subscales (p=0.001). Interaction: interval and subscales (p=0.023).||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Subscales include: ease of communication, reverberation, effectiveness in background noise, and reverberation. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.023
71104515|NCT01107496|141716376|SUPERIORITY||Median Difference (Net)|-6.0||||0.0747|TWO_SIDED|95.0|-10.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 4 data.||0.00|-10.0|0.0747
71104516|NCT01107496|141716376|SUPERIORITY||Median Difference (Net)|-6.5||||0.0545|TWO_SIDED|95.0|-12.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 5 data.||0.00|-12.0|0.0545
71104517|NCT01107496|141716377|SUPERIORITY||Median Difference (Net)|7.0||||0.0349|TWO_SIDED|95.0|1.0|13.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 6 data.||13.00|1.00|0.0349
71104518|NCT01107496|141716378|SUPERIORITY||Median Difference (Net)|-0.5||||0.4038|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||Analysis pertains to Week 1 data||0.00|-1.00|0.4038
71014941|NCT02203305|141537193|SUPERIORITY||||||<|0.643|||||||Mixed Models Analysis|Main effects: interval (p=0.643) and subscale (p=0.005). Interaction: interval and subscale (p=0.480).||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Subscales include: ease of communication, reverberation, effectiveness in background noise, and reverberation. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.643
71104519|NCT01107496|141716378|SUPERIORITY||Median Difference (Net)|-0.5||||0.446|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||Analysis pertains to Week 2 data||0.00|-1.00|0.4460
71104520|NCT01107496|141716378|SUPERIORITY||Median Difference (Net)|-0.5||||0.0549|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||Analysis pertains to Week 3 data||0.00|-1.00|0.0549
71104521|NCT01107496|141716378|SUPERIORITY||Median Difference (Net)|-0.5||||0.0759|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||Analysis pertains to Week 4 data||0.00|-1.00|0.0759
71049257|NCT02504671|141606186|OTHER||Mean Difference (Net)|-0.32||||0.103|TWO_SIDED|95.0|-0.71|0.07||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2|||0.07|-0.71|0.103
71049258|NCT02504671|141606186|OTHER||Mean Difference (Net)|-0.42||||0.034|TWO_SIDED|95.0|-0.8|-0.03||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2|||-0.03|-0.80|0.034
71049259|NCT02504671|141606186|OTHER||Mean Difference (Net)|-0.4||||0.096|TWO_SIDED|95.0|-0.87|0.07||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4|||0.07|-0.87|0.096
71049260|NCT02504671|141606186|OTHER||Mean Difference (Net)|-0.56||||0.02|TWO_SIDED|95.0|-1.02|-0.09||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4|||-0.09|-1.02|0.020
71049261|NCT02504671|141606186|OTHER||Mean Difference (Net)|-0.76||||0.001|TWO_SIDED|95.0|-1.22|-0.29||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4|||-0.29|-1.22|0.001
71049262|NCT02504671|141606186|OTHER||Mean Difference (Net)|-0.42||||0.11|TWO_SIDED|95.0|-0.93|0.1||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6|||0.10|-0.93|0.110
71104522|NCT01107496|141716378|SUPERIORITY||Median Difference (Net)|-0.5||||0.0342|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||Analysis pertains to Week 5 data||0.00|-1.00|0.0342
71049263|NCT02504671|141606186|OTHER||Mean Difference (Net)|-0.47||||0.076|TWO_SIDED|95.0|-0.98|0.05||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6|||0.05|-0.98|0.076
71049264|NCT02504671|141606186|OTHER||Mean Difference (Net)|-0.61||||0.02|TWO_SIDED|95.0|-1.11|-0.1||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6|||-0.10|-1.11|0.020
71049265|NCT02504671|141606186|OTHER||Mean Difference (Net)|-0.42||||0.128|TWO_SIDED|95.0|-0.97|0.12||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8|||0.12|-0.97|0.128
71104523|NCT01107496|141716378|SUPERIORITY||Median Difference (Net)|-1.0||||0.0474|TWO_SIDED||||||Wilcoxon rank-sum test|||Analysis pertains to Week 6 data||||0.0474
71104524|NCT02496000|141716385|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0117|||||||Kruskal-Wallis|ANOVA model on the ranks||This outcome measure requires that the the mean differences of ORMD-0801 in each of the two arms be pooled.||||0.0117
71104525|NCT01877278|141716416|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71104526|NCT01877278|141716416|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>0.05
71104527|NCT01877278|141716417|SUPERIORITY_OR_OTHER||||||=|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||=0.0001
71104528|NCT01877278|141716417|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>0.05
71104529|NCT01969058|141716418|SUPERIORITY|||||||0.03||||||Not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two arms in the change in T-cell activation from baseline to week 14/16.||||0.030
71104530|NCT05318287|141716444|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.03||0.083|TWO_SIDED||||||t-test, 2 sided|||||||.083
71104531|NCT05318287|141716445|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.02||0.01|TWO_SIDED||||||t-test, 2 sided|||||||.010
71104532|NCT05318287|141716446|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.16|TWO_SIDED||||||t-test, 2 sided|||||||.160
71104533|NCT05318287|141716447|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|0.01|STANDARD_ERROR_OF_MEAN|0.01||0.167|TWO_SIDED||||||t-test, 2 sided|||||||.167
71104534|NCT05318287|141716448|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.012|TWO_SIDED||||||t-test, 2 sided|||||||.012
71104535|NCT05318287|141716449|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.347|TWO_SIDED||||||t-test, 2 sided|||||||.347
71014942|NCT02203305|141537193|OTHER|bivariate pearson correlation (one-tailed)|||||=|0.947||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Noise Subscale) at the preoperative interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.947
71014943|NCT02203305|141537193|SUPERIORITY||||||=|0.5||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Noise Subscale) at the preoperative interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.500
71014944|NCT02203305|141537193|OTHER|bivariate pearson correlation|bivariate pearson correlation|-0.51|||=|0.023|TWO_SIDED|||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Noise Subscale) at the 12-month interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.023
71014945|NCT02203305|141537193|OTHER|bivariate pearson correlation|bivariate pearson correlation|-0.55|||=|0.033|TWO_SIDED|||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Noise Subscale) at the 12-month interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.033
71014946|NCT02203305|141537193|SUPERIORITY||||||>|0.208|||||||Mixed Models Analysis|Main effects: cohort (p=0.541), interval (p=0.446), and subscale (p=0.208). Interactions: 2-way or 3-way (p\>0.287).||Comparison of subjective benefit between groups (UHL/SSD and AHL) on the ease of communication, background noise, and reverberation subscales over the post-activation intervals (1, 3, 6, 9, and 12 months).||||>0.208
71014947|NCT02203305|141537194|SUPERIORITY||||||=|0.221||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||"The Tinnitus Handicap Inventory is a 25-item questionnaire. The subject answers yes (4 points), sometimes (2 points), or no (0 points) to each question. Responses are added to quantify tinnitus severity: none/slight (0-16), mild (18-36), moderate (38-56), severe (58-76), and catastrophic (78-100). Responses were compared over the post-activation time period (1, 3, 6, 9, and 12 months)."||||=0.221
71014948|NCT02203305|141537194|SUPERIORITY||||||=|0.538||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||"The Tinnitus Handicap Inventory is a 25-item questionnaire. The subject answers yes (4 points), sometimes (2 points), or no (0 points) to each question. Responses are added to quantify tinnitus severity: none/slight (0-16), mild (18-36), moderate (38-56), severe (58-76), and catastrophic (78-100). Responses were compared over the post-activation time period (1, 3, 6, 9, and 12 months)."||||=0.538
71049266|NCT02504671|141606186|OTHER||Mean Difference (Net)|-0.78||||0.005|TWO_SIDED|95.0|-1.33|-0.24||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8|||-0.24|-1.33|0.005
71049267|NCT02504671|141606186|OTHER||Mean Difference (Net)|-0.82||||0.003|TWO_SIDED|95.0|-1.36|-0.29||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8|||-0.29|-1.36|0.003
71049268|NCT02504671|141606186|OTHER||Mean Difference (Net)|-0.53||||0.11|TWO_SIDED|95.0|-1.17|0.12||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12|||0.12|-1.17|0.110
71049269|NCT02504671|141606186|OTHER||Mean Difference (Net)|-0.88||||0.008|TWO_SIDED|95.0|-1.53|-0.23||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12|||-0.23|-1.53|0.008
71049270|NCT02504671|141606186|OTHER||Mean Difference (Net)|-1.24|||<|0.001|TWO_SIDED|95.0|-1.88|-0.6||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12|||-0.60|-1.88|<0.001
71049271|NCT02504671|141606186|OTHER||Mean Difference (Net)|-0.29||||0.5|TWO_SIDED|95.0|-1.15|0.56||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16|||0.56|-1.15|0.500
71049272|NCT02504671|141606186|OTHER||Mean Difference (Net)|-0.99||||0.021|TWO_SIDED|95.0|-1.83|-0.15||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16|||-0.15|-1.83|0.021
71049273|NCT02504671|141606186|OTHER||Mean Difference (Net)|-1.0||||0.017|TWO_SIDED|95.0|-1.83|-0.18||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16|||-0.18|-1.83|0.017
71049274|NCT02504671|141606186|OTHER||Mean Difference (Net)|-0.07||||0.871|TWO_SIDED|95.0|-0.98|0.83||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20|||0.83|-0.98|0.871
71049275|NCT02504671|141606186|OTHER||Mean Difference (Net)|-0.58||||0.19|TWO_SIDED|95.0|-1.46|0.29||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20|||0.29|-1.46|0.190
71049276|NCT02504671|141606186|OTHER||Mean Difference (Net)|-0.66||||0.13|TWO_SIDED|95.0|-1.51|0.2||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20|||0.20|-1.51|0.130
71049277|NCT02504671|141606186|OTHER||Mean Difference (Net)|-1.22||||0.019|TWO_SIDED|95.0|-2.24|-0.2||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24|||-0.20|-2.24|0.019
71049278|NCT02504671|141606186|OTHER||Mean Difference (Net)|-1.53||||0.002|TWO_SIDED|95.0|-2.51|-0.55||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24|||-0.55|-2.51|0.002
71049279|NCT02504671|141606186|OTHER||Mean Difference (Net)|-1.39||||0.005|TWO_SIDED|95.0|-2.34|-0.43||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24|||-0.43|-2.34|0.005
71049280|NCT02504671|141606186|OTHER||Mean Difference (Net)|-0.41||||0.013|TWO_SIDED|95.0|-0.73|-0.09||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1|||-0.09|-0.73|0.013
71014949|NCT02203305|141537194|SUPERIORITY||||||>|0.218||||||There were no significant main effects of cohort (p=0.265) or interval (p=0.430). There was no significant interaction between cohort and interval (p=0.218).|Mixed Models Analysis|Main effects: cohort (p=0.265) or interval (p=0.430). Interaction: cohort and interval (p=0.218).||Comparison of subjective benefit between groups (UHL/SSD and AHL) on the Tinnitus Handicap Inventory over the post-activation intervals (1, 3, 6, 9, and 12 months).||||>0.218
71014950|NCT02203305|141537195|SUPERIORITY||||||<|0.322||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|Mixed Models Analysis|Main effect: interval (p=0.084) and condition (p=0.322). Interaction: interval and condition (p=0.125).||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.322
71014951|NCT02203305|141537195|SUPERIORITY||||||<|0.317||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|Mixed Models Analysis|Main effects: interval (p=0.014) and condition (p=0.317). Interaction: interval and condition (p=0.118).||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.317
71104536|NCT05318287|141716450|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|0.05|STANDARD_ERROR_OF_MEAN|0.02||0.007|TWO_SIDED||||||t-test, 2 sided|||||||.007
71104537|NCT05318287|141716451|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.02||0.001|TWO_SIDED||||||t-test, 2 sided|||||||.001
71104538|NCT05318287|141716452|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.403|TWO_SIDED||||||t-test, 2 sided|||||||.403
71104539|NCT05318287|141716453|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.01||0.194|TWO_SIDED||||||t-test, 2 sided|||||||.194
71104540|NCT00391716|141716479|SUPERIORITY_OR_OTHER||||||<|0.04|TWO_SIDED|||||The numerator is the number of subjects completely abstinent and the denominator is the number of subjects randomized, within each treatment group.|Mantel Haenszel|Extended Mantel-Haenszel Chi-square test for linear-by-linear association.||The extended Mantel-Haenszel Chi-square test for linear trend assesses the relationship between ROW and COLUMN of a single contingency table, where both row (dose: 0mg, 900mg, 1800mg) and column (response (0= non-abstinent, 1=abstinent), and at least 1 variable has more than 2 levels. It specifically tests linear dose-response without need for multiple comparisons.||||<0.04
71104541|NCT00391716|141716479|SUPERIORITY_OR_OTHER||||||<|0.02|TWO_SIDED|||||linear dose effects for rates of abstinence were assessed using the extended Mantel-Haenszel chi-square test for linear association.|Mantel Haenszel|The numerator is the number of subjects completely abstinent and the denominator is the number of subjects randomized, within each treatment group.||The extended Mantel-Haenszel Chi-square test for linear trend assesses the relationship between ROW and COLUMN of a single contingency table, where both row (dose: 0mg, 900mg, 1800mg) and column (response (0= heavy drinking, 1=no heavy drinking), and at least 1 variable has more than 2 levels. It specifically tests linear dose-response without need for multiple comparisons.||||<0.02
71104542|NCT00391716|141716480|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Cumulative means over 12 weeks|ANOVA|||||||<0.001
71104543|NCT00391716|141716481|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Cumulative means over 12 weeks|ANOVA|||||||<0.001
71104544|NCT00391716|141716482|SUPERIORITY_OR_OTHER||||||<|0.003||||||Cumulative means over 12 weeks|ANOVA|||||||<0.003
71104545|NCT00934180|141716512|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|103.0||||||90.0|95.1|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111|95.1|
71104546|NCT00934180|141716513|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|101.0||||||90.0|95.3|107.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107|95.3|
71104547|NCT00934180|141716514|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|101.0||||||90.0|95.2|108.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||108|95.2|
71104548|NCT00835172|141716515|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|102.0||||||90.0|92.1|112.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||112|92.1|
71104549|NCT00835172|141716516|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|96.8|105.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105|96.8|
71104550|NCT00835172|141716517|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|103.0||||||90.0|99.3|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106|99.3|
70850619|NCT02712047|141189438|OTHER||Mean Difference (Net)|14.71|||||TWO_SIDED|95.0|-7.57|36.98|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 11, AM|||36.98|-7.57|
71014952|NCT02203305|141537195|SUPERIORITY||||||=|0.017||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|||Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||=0.017
71014953|NCT02203305|141537195|SUPERIORITY||||||=|0.292||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|||Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||=0.292
71014954|NCT02203305|141537195|OTHER|pearson correlation|||||>|0.185|||||||bivariate pearson correlation|||Association of word recognition and speech recognition in noise, analyzed with a Bivariate Pearson correlation. Scores were averaged between 3 and 12 months post-activation as an estimate of asymptotic performance.||||>0.185
71014955|NCT02203305|141537196|SUPERIORITY||||||<|0.581||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|Mixed Models Analysis|Main effect: interval (p=0.039) and condition (p=0.007). Interaction: interval and condition (p=0.581).||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.581
71014956|NCT02203305|141537196|SUPERIORITY||||||<|0.817||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|Mixed Models Analysis|Main effects: condition (p=0.005) and interval (p=0.528). Interaction: condition and interval (p=0.817).||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.817
71014957|NCT02203305|141537196|SUPERIORITY||||||=|0.008||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||=0.008
71014958|NCT02203305|141537196|SUPERIORITY||||||=|0.009|||||||ANOVA|||Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||=0.009
71014959|NCT02203305|141537196|OTHER|bivariate correlation|||||=|0.049||||||"Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.~This correlation was no longer significant when controlling for the hearing threshold at 8000 Hz."|bivariate pearson correlation|||Association of age at implantation and performance at the 12-month interval with the cochlear implant, analyzed with a Bivariate Pearson correlation (one-tailed).||||=0.049
71014960|NCT02203305|141537196|OTHER|pearson correlation|||||>|0.185|||||||bivariate pearson correlation|||Association of word recognition and speech recognition in noise, analyzed with a Bivariate Pearson correlation. Scores were averaged between 3 and 12 months post-activation as an estimate of asymptotic performance.||||>0.185
71014961|NCT02203305|141537197|SUPERIORITY||||||<|0.44|||||||Mixed Models Analysis|Main effects: interval (p=0.070) and condition (p=0.440). Interaction: interval and condition (p=0.047).||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.440
71014962|NCT02203305|141537197|SUPERIORITY||||||<|0.379|||||||Mixed Models Analysis|Main effects: condition (p\<0.001) and interval (p=0.250). Interaction: interval and condition (p=0.379).||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.379
71014963|NCT02203305|141537197|SUPERIORITY||||||=|0.021|||||||ANOVA|||Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).||||=0.021
71014964|NCT02203305|141537197|SUPERIORITY||||||<|0.001|||||||ANOVA|||Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).||||<0.001
71014965|NCT02203305|141537198|SUPERIORITY||||||<|0.639||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effect: condition (p\<0.001) and interval (p=0.639). Interaction: interval and condition (p=0.280).||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.639
71049281|NCT02504671|141606186|OTHER||Mean Difference (Net)|-0.49||||0.003|TWO_SIDED|95.0|-0.8|-0.17||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1|||-0.17|-0.80|0.003
71049282|NCT02504671|141606186|OTHER||Mean Difference (Net)|-0.47||||0.017|TWO_SIDED|95.0|-0.86|-0.09||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2|||-0.09|-0.86|0.017
71049283|NCT02504671|141606186|OTHER||Mean Difference (Net)|-0.52||||0.009|TWO_SIDED|95.0|-0.9|-0.13||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2|||-0.13|-0.90|0.009
71049284|NCT02504671|141606186|OTHER||Mean Difference (Net)|-0.67||||0.005|TWO_SIDED|95.0|-1.13|-0.2||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4|||-0.20|-1.13|0.005
71049285|NCT02504671|141606186|OTHER||Mean Difference (Net)|-1.01|||<|0.001|TWO_SIDED|95.0|-1.48|-0.55||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4|||-0.55|-1.48|<0.001
71049286|NCT02504671|141606186|OTHER||Mean Difference (Net)|-0.47||||0.073|TWO_SIDED|95.0|-0.99|0.04||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6|||0.04|-0.99|0.073
71049287|NCT02504671|141606186|OTHER||Mean Difference (Net)|-0.85||||0.001|TWO_SIDED|95.0|-1.36|-0.34||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6|||-0.34|-1.36|0.001
71049288|NCT02504671|141606186|OTHER||Mean Difference (Net)|-0.89||||0.001|TWO_SIDED|95.0|-1.43|-0.35||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8|||-0.35|-1.43|0.001
71049289|NCT02504671|141606186|OTHER||Mean Difference (Net)|-1.1|||<|0.001|TWO_SIDED|95.0|-1.65|-0.56||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8|||-0.56|-1.65|<0.001
70929935|NCT02938923|141357386|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.494|TWO_SIDED|95.0|-0.88|0.43||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.69|Difference between the BADL changes (EX+T - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||0.43|-0.88|0.494
71049290|NCT02504671|141606186|OTHER||Mean Difference (Net)|-0.68||||0.039|TWO_SIDED|95.0|-1.32|-0.03||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12|||-0.03|-1.32|0.039
71049291|NCT02504671|141606186|OTHER||Mean Difference (Net)|-1.27|||<|0.001|TWO_SIDED|95.0|-1.91|-0.63||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12|||-0.63|-1.91|<0.001
71049292|NCT02504671|141606186|OTHER||Mean Difference (Net)|-0.77||||0.073|TWO_SIDED|95.0|-1.61|0.07||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16|||0.07|-1.61|0.073
71049293|NCT02504671|141606186|OTHER||Mean Difference (Net)|-1.11||||0.007|TWO_SIDED|95.0|-1.91|-0.3||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16|||-0.30|-1.91|0.007
71049294|NCT02504671|141606186|OTHER||Mean Difference (Net)|-0.77||||0.083|TWO_SIDED|95.0|-1.65|0.1||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20|||0.10|-1.65|0.083
71049295|NCT02504671|141606186|OTHER||Mean Difference (Net)|-0.8||||0.059|TWO_SIDED|95.0|-1.63|0.03||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20|||0.03|-1.63|0.059
71049296|NCT02504671|141606186|OTHER||Mean Difference (Net)|-1.48||||0.003|TWO_SIDED|95.0|-2.46|-0.5||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24|||-0.50|-2.46|0.003
71049297|NCT02504671|141606186|OTHER||Mean Difference (Net)|-1.82|||<|0.001|TWO_SIDED|95.0|-2.75|-0.89||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24|||-0.89|-2.75|<0.001
71049298|NCT02504671|141606188|OTHER||Difference|16.2||||0.037|TWO_SIDED|95.0|1.1|31.4|||Regression, Logistic||Difference to placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.4|1.1|0.037
71049299|NCT02504671|141606188|OTHER||Difference|10.8||||0.144|TWO_SIDED|95.0|-3.1|24.7|||Regression, Logistic||Difference to placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.7|-3.1|0.144
71049300|NCT02504671|141606188|OTHER||Difference|18.9||||0.033|TWO_SIDED|95.0|3.3|34.5|||Regression, Logistic||Difference to placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||34.5|3.3|0.033
71049301|NCT02504671|141606188|OTHER||Difference|5.4||||0.437|TWO_SIDED|95.0|-11.3|22.2|||Regression, Logistic||Difference to placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||22.2|-11.3|0.437
71049302|NCT02504671|141606188|OTHER||Difference|2.7||||0.755|TWO_SIDED|95.0|-13.5|18.9|||Regression, Logistic||Difference to placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||18.9|-13.5|0.755
71049303|NCT02504671|141606188|OTHER||Difference|24.3||||0.023|TWO_SIDED|95.0|5.2|43.4|||Regression, Logistic||Difference to placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||43.4|5.2|0.023
71049304|NCT02504671|141606188|OTHER||Difference|29.7||||0.006|TWO_SIDED|95.0|9.8|49.7|||Regression, Logistic||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||49.7|9.8|0.006
71049305|NCT02504671|141606188|OTHER||Difference|21.6||||0.039|TWO_SIDED|95.0|2.0|41.2|||Regression, Logistic||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||41.2|2.0|0.039
71049306|NCT02504671|141606188|OTHER||Difference|29.7||||0.008|TWO_SIDED|95.0|9.8|49.7|||Regression, Logistic||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||49.7|9.8|0.008
71014966|NCT02203305|141537198|SUPERIORITY||||||<|0.637|||||||Mixed Models Analysis|Main effects: condition (p\<0.001) and interval (p=0.637). Interaction: interval and condition (p=0.450).||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.637
71014967|NCT02203305|141537198|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).||||<0.001
71014968|NCT02203305|141537198|SUPERIORITY||||||=|0.002|||||||ANOVA|||Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).||||=0.002
71014969|NCT02203305|141537199|SUPERIORITY||||||<|0.671|||||||Mixed Models Analysis|Main effects: interval (p=0.020) and condition (p=0.406). Interaction: interval and condition (p=0.671).||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.671
71014970|NCT02203305|141537199|SUPERIORITY||||||>|0.124|||||||Mixed Models Analysis|Main effects: interval (p=0.124) and condition (p=0.845). Interaction: interval and condition (p=0.960).||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||>0.124
71014971|NCT02203305|141537199|SUPERIORITY||||||=|0.025|||||||ANOVA|||Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).||||=0.025
71014972|NCT02203305|141537199|SUPERIORITY||||||=|0.442|||||||ANOVA|||Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).||||=0.442
71014973|NCT02203305|141537200|SUPERIORITY||||||<|0.001||||||Percent correct values were converted to rationalized arcsine units prior to analysis.|t-test, 2 sided|||Paired samples t-test comparing word recognition (percent correct for CNC words) with a hearing aid at the pre-operative interval and the cochlear implant at the 12-month interval for the affected ear (masking presented to the contralateral ear).||||<0.001
71014974|NCT02203305|141537200|SUPERIORITY||||||<|0.001||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|t-test, 2 sided|||Paired samples t-test comparing word recognition (percent correct for CNC words) with a hearing aid at the pre-operative interval and the cochlear implant at the 12-month interval for the affected ear (masking presented to the contralateral ear).||||<0.001
71014975|NCT02203305|141537201|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Participants listened with a bone conduction device preoperatively and with the cochlear implant at 1, 3, 6, 9, and 12 months post-activation. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. Repeated-measures ANOVA compared performance over time.||||<0.001
71014976|NCT02203305|141537201|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Participants listening with a bone conduction device preoperatively and with the cochlear implant at 1, 3, 6, 9, and 12 months post-activation. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. Repeated-measures ANOVA compared performance over time.||||<0.001
71014977|NCT02203305|141537201|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Compare localization performance with the cochlear implant to a bone-conduction device at the 12-month interval using a paired samples t-test.||||<0.001
71014978|NCT02203305|141537201|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Compare localization performance with the cochlear implant to a bone-conduction device at the 12-month interval using a paired samples t-test.||||<0.001
71049307|NCT02504671|141606188|OTHER||Difference|21.6||||0.044|TWO_SIDED|95.0|0.4|42.8|||Regression, Logistic||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.8|0.4|0.044
70850620|NCT02712047|141189438|OTHER||Mean Difference (Net)|-6.62|||||TWO_SIDED|95.0|-28.8|15.55|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 11, PM|||15.55|-28.80|
71049308|NCT02504671|141606188|OTHER||Difference|18.9||||0.083|TWO_SIDED|95.0|-2.2|40.0|||Regression, Logistic||Difference to placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||40.0|-2.2|0.083
71049309|NCT02504671|141606188|OTHER||Difference|27.0|||||TWO_SIDED|95.0|5.8|48.3|||||Difference to placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.3|5.8|
71049310|NCT02504671|141606188|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-11.2|32.8|||||Difference to placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.Wald confidence limits without correction.|||32.8|-11.2|
71049311|NCT02504671|141606188|OTHER||Difference|27.0|||||TWO_SIDED|95.0|5.2|48.9|||||Difference to placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.9|5.2|
71049312|NCT02504671|141606188|OTHER||Difference|32.4|||||TWO_SIDED|95.0|10.9|54.0|||||Difference to placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||54.0|10.9|
70929936|NCT02938923|141357386|SUPERIORITY||Mean Difference (Final Values)|-0.45||||0.18|TWO_SIDED|95.0|-1.11|0.21||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -1.35|Difference between the BADL changes (EX+P - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||0.21|-1.11|0.180
71014979|NCT02203305|141537202|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is calculated from the responses on the ease of communication, reverberation, and effectiveness in background noise subscales. Responses at the preoperative interval (alternative treatments for unilateral hearing loss) were compared to responses over time with the cochlear implant using a repeated-measures ANOVA.||||<0.001
71014980|NCT02203305|141537202|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is calculated from the responses on the ease of communication, reverberation, and effectiveness in background noise subscales. Responses at the preoperative interval (alternative treatments for unilateral hearing loss) were compared to responses over time with the cochlear implant using a repeated-measures ANOVA.||||<0.001
71014981|NCT02203305|141537202|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p\<0.001) and subscales (p\<0.001). Interaction: interval and subscales (p\<0.001).||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Subscales include: ease of communication, reverberation, effectiveness in background noise, and reverberation. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction from the preoperative interval (alternative treatments) and over time with the cochlear implant.||||<0.001
71014982|NCT02203305|141537202|SUPERIORITY||||||<|0.01||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p\<0.001) and subscales (p=0.010). Interaction: interval and subscales (p=0.001).||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Subscales include: ease of communication, reverberation, effectiveness in background noise, and reverberation. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction from the preoperative interval (alternative treatments) and over time with the cochlear implant.||||<0.010
71014983|NCT02203305|141537203|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||"The Tinnitus Handicap Inventory is a 25-item questionnaire. The subject answers yes (4 points), sometimes (2 points), or no (0 points) to each question. Responses are added to quantify tinnitus severity: none/slight (0-16), mild (18-36), moderate (38-56), severe (58-76), and catastrophic (78-100). Responses were compared at the preoperative interval (alternative treatments) and over the post-activation time period (1, 3, 6, 9, and 12 months) with the cochlear implant."||||<0.001
71014984|NCT02203305|141537203|SUPERIORITY||||||=|0.003||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||"The Tinnitus Handicap Inventory is a 25-item questionnaire. The subject answers yes (4 points), sometimes (2 points), or no (0 points) to each question. Responses are added to quantify tinnitus severity: none/slight (0-16), mild (18-36), moderate (38-56), severe (58-76), and catastrophic (78-100). Responses were compared at the preoperative interval (alternative treatments) and over the post-activation time period (1, 3, 6, 9, and 12 months) with the cochlear implant."||||=0.003
71049313|NCT02504671|141606188|OTHER||Difference|21.6|||||TWO_SIDED|95.0|0.9|42.4|||||Difference to placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.4|0.9|
71049314|NCT02504671|141606188|OTHER||Difference|29.7|||||TWO_SIDED|95.0|8.9|50.6|||||Difference to placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||50.6|8.9|
71014985|NCT02203305|141537204|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Responses on the SSQ as measured with the total score were compared at the preoperative interval (alternative treatments for SSD) and over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).||||<0.001
71014986|NCT02203305|141537204|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Responses on the SSQ as measured with the total score were compared at the preoperative interval (alternative treatments for asymmetric hearing loss) and over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).||||<0.001
71014987|NCT02203305|141537204|SUPERIORITY||||||<|0.001||||||"There were significant main effects of interval (p\<0.001) and subscale (p\<0.001) and interaction (p=0.001).~A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity."|Mixed Models Analysis|Main effects: interval (p\<0.001) and subscale (p\<0.001). Interaction: interval and subscale (p=0.001).||Responses on the SSQ as measured with the subscales (speech, spatial, \& qualities) were compared at the preoperative interval (alternative treatments for SSD) and over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA assessed the main effects of interval and subscale, and their interaction.||||<0.001
71049315|NCT02504671|141606188|OTHER||Difference|45.9|||||TWO_SIDED|95.0|25.9|66.0|||||Difference to placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||66.0|25.9|
71049316|NCT02504671|141606188|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-6.8|33.8|||||Difference to placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.8|-6.8|
71049317|NCT02504671|141606188|OTHER||Difference|32.4|||||TWO_SIDED|95.0|11.6|53.3|||||Difference to placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||53.3|11.6|
71049318|NCT02504671|141606188|OTHER||Difference|37.8|||||TWO_SIDED|95.0|17.2|58.5|||||Difference to placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||58.5|17.2|
71014988|NCT02203305|141537204|SUPERIORITY||||||<|0.034||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p\<0.001) and subscale (p\<0.001). Interaction: interval and subscale (p=0.034).||Responses on the SSQ as measured with the subscales (speech, spatial, \& qualities) were compared at the preoperative interval (alternative treatments for asymmetric hearing loss) and over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA assessed the main effects of interval and subscale, and their interaction.||||<0.034
71049319|NCT02504671|141606188|OTHER||Difference|18.9|||||TWO_SIDED|95.0|-0.5|38.4|||||Difference to placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||38.4|-0.5|
71049320|NCT02504671|141606188|OTHER||Difference|35.1|||||TWO_SIDED|95.0|15.1|55.1|||||Difference to placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||55.1|15.1|
71049321|NCT02504671|141606188|OTHER||Difference|48.6|||||TWO_SIDED|95.0|29.2|68.1|||||Difference to placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||68.1|29.2|
71049322|NCT02504671|141606188|OTHER||Difference|16.2|||||TWO_SIDED|95.0|-3.0|35.4|||||Difference to placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||35.4|-3.0|
71049323|NCT02504671|141606188|OTHER||Difference|29.7|||||TWO_SIDED|95.0|9.8|49.7|||||Difference to placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||49.7|9.8|
71049324|NCT02504671|141606188|OTHER||Difference|37.8|||||TWO_SIDED|95.0|17.9|57.8|||||Difference to placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||57.8|17.9|
70850621|NCT02712047|141189438|OTHER||Mean Difference (Net)|4.36|||||TWO_SIDED|95.0|-18.39|27.11|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 12, AM|||27.11|-18.39|
71014989|NCT02203305|141537204|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Main effects: interval (p\<0.001) and pragmatic subscale (p\<0.001). Interaction: interval and pragmatic subscale (p\<0.001).||Responses on the SSQ Speech pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.||||<0.001
71014990|NCT02203305|141537204|SUPERIORITY||||||<|0.192|||||||Mixed Models Analysis|Main effect: interval (p\<0.001) and pragmatic subscale (p=0.192). Interaction: interval and pragmatic subscale (p=0.001).||Responses on the SSQ Spatial pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.||||<0.192
71014991|NCT02203305|141537204|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Main effects: interval (p\<0.001) and pragmatic subscale (p\<0.001). Interaction: interval and pragmatic subscale (p\<0.001).||Responses on the SSQ Qualities of Hearing pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.||||<0.001
71014992|NCT02203305|141537204|SUPERIORITY||||||<|0.479|||||||Mixed Models Analysis|Main effects: interval (p\<0.001) and pragmatic subscale (p\<0.001). Interaction: interval and pragmatic subscale (p=0.479).||Responses on the SSQ Speech pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.||||<0.479
71014993|NCT02203305|141537204|SUPERIORITY||||||<|0.804|||||||Mixed Models Analysis|Main effect: interval (p\<0.001) and pragmatic subscale (p=0.804). Interaction: interval and pragmatic subscale (p=0.090).||Responses on the SSQ Spatial pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.||||<0.804
71014994|NCT02203305|141537204|SUPERIORITY||||||<|0.005|||||||Mixed Models Analysis|Main effects: interval (p\<0.001) and pragmatic subscale (p\<0.001). Interaction: interval and pragmatic subscale (p=0.005).||Responses on the SSQ Qualities of Hearing pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.||||<0.005
71014995|NCT02203305|141537205|SUPERIORITY||||||=|0.001|||||||t-test, 2 sided|||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.||||=0.001
71014996|NCT02203305|141537205|SUPERIORITY||||||=|0.034|||||||t-test, 2 sided|||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.||||=0.034
71014997|NCT02203305|141537206|SUPERIORITY||||||=|0.001|||||||t-test, 2 sided|||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.||||=0.001
71049325|NCT02504671|141606188|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Difference to placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71049326|NCT02504671|141606188|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Difference to placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71049327|NCT02504671|141606188|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Difference to placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71049328|NCT02504671|141606188|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Difference to placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
70929937|NCT02938923|141357386|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.693|TWO_SIDED|95.0|-0.75|0.5||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.4|Difference between the changes of IADL of EX+T - EX+P|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.50|-0.75|0.693
70929938|NCT02938923|141357386|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.327|TWO_SIDED|95.0|-1.27|0.43||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.98|Difference between the IADL changes (EX+T - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.43|-1.27|0.327
70929939|NCT02938923|141357386|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.493|TWO_SIDED|95.0|-1.15|0.56||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.69|Difference between the IADL changes (EX+P - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.56|-1.15|0.493
70929940|NCT02938923|141357386|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.698|TWO_SIDED|95.0|-0.72|0.49||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.39|Difference between the IADL changes (EX+T - EX+P)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.49|-0.72|0.698
70929941|NCT02938923|141357386|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.404|TWO_SIDED|95.0|-1.17|0.47||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.84|Difference between the IADL changes (EX+T - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.47|-1.17|0.404
70929942|NCT02938923|141357386|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.585|TWO_SIDED|95.0|-1.06|0.6||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.55|Difference between the IADL changes (EX+P - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.60|-1.06|0.585
70929943|NCT02938923|141357386|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.399|TWO_SIDED|95.0|-0.31|0.76||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.85|Difference between IADL changes (EX+T - EX+P)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.76|-0.31|0.399
70929944|NCT02938923|141357386|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.554|TWO_SIDED|95.0|-0.53|0.98||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.59|Difference between the IADL changes (EX+T - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.98|-0.53|0.554
71014998|NCT02203305|141537206|SUPERIORITY||||||=|0.037|||||||t-test, 2 sided|||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.||||=0.037
71014999|NCT02203305|141537207|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.||||<0.001
71015000|NCT02203305|141537207|SUPERIORITY||||||=|0.001|||||||t-test, 2 sided|||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.||||=0.001
71049329|NCT02504671|141606188|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Difference to placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
71104551|NCT03274466|141716539|SUPERIORITY|Modified Intent-To-Treat|Odds Ratio (OR)|0.22||||0.0013|TWO_SIDED|95.0|0.08|0.59||Threshold for statistical significance: alpha = 0.048|Cochran-Mantel-Haenszel|||||0.59|0.08|0.0013
70929945|NCT02938923|141357386|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.998|TWO_SIDED|95.0|-0.76|0.76||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0|Difference between the IADL changes (EX+P - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.76|-0.76|0.998
70929946|NCT02938923|141357386|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.378|TWO_SIDED|95.0|-0.28|0.73||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.88|Difference between the IADL changes (EX+T - EX+P)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.73|-0.28|0.378
71049330|NCT02504671|141606188|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Difference to placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
71049331|NCT02504671|141606188|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Difference to placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71049332|NCT02504671|141606188|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Difference to placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71049333|NCT02504671|141606188|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Difference to placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
71015001|NCT02203305|141537208|SUPERIORITY||||||=|0.004|||||||t-test, 2 sided|||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) with a bone-conduction device (preoperative interval) and 2) with the cochlear implant (CI) at the 12-month post-activation interval. Results are reported in dB SNR, where a lower value indicates better performance. A paired samples t-test compared the performance with the two devices.||||=0.004
71049334|NCT02504671|141606188|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Difference to placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71049335|NCT02504671|141606188|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Difference to placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71049336|NCT02504671|141606188|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Difference to placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
71049337|NCT02504671|141606188|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Difference to placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71049338|NCT02504671|141606188|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Difference to placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71049339|NCT02504671|141606188|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Difference to placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71049340|NCT02504671|141606188|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Difference to placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71049341|NCT02504671|141606188|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049342|NCT02504671|141606188|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049343|NCT02504671|141606188|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Difference to placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
71049344|NCT02504671|141606188|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049345|NCT02504671|141606188|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049346|NCT02504671|141606188|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Difference to placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
71049347|NCT02504671|141606188|OTHER||Difference|21.6|||||TWO_SIDED|95.0|5.6|37.7|||||Difference to placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||37.7|5.6|
71049348|NCT02504671|141606188|OTHER||Difference|18.9|||||TWO_SIDED|95.0|0.2|37.6|||||Difference to placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||37.6|0.2|
71049349|NCT02504671|141606188|OTHER||Difference|24.3|||||TWO_SIDED|95.0|5.2|43.4|||||Difference to placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||43.4|5.2|
71049350|NCT02504671|141606188|OTHER||Difference|27.0|||||TWO_SIDED|95.0|7.1|46.9|||||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||46.9|7.1|
71049351|NCT02504671|141606188|OTHER||Difference|51.4|||||TWO_SIDED|95.0|32.2|70.5|||||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||70.5|32.2|
71049352|NCT02504671|141606188|OTHER||Difference|21.6|||||TWO_SIDED|95.0|0.4|42.8|||||Difference to placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.8|0.4|
71049353|NCT02504671|141606188|OTHER||Difference|40.5|||||TWO_SIDED|95.0|19.9|61.2|||||Difference to placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||61.2|19.9|
71049354|NCT02504671|141606188|OTHER||Difference|27.0|||||TWO_SIDED|95.0|5.2|48.9|||||Difference to placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.9|5.2|
71049355|NCT02504671|141606188|OTHER||Difference|35.1|||||TWO_SIDED|95.0|13.8|56.5|||||Difference to placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||56.5|13.8|
71049356|NCT02504671|141606188|OTHER||Difference|27.0|||||TWO_SIDED|95.0|6.2|47.9|||||Difference to placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||47.9|6.2|
71049357|NCT02504671|141606188|OTHER||Difference|54.1|||||TWO_SIDED|95.0|34.9|73.2|||||Difference to placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||73.2|34.9|
71049358|NCT02504671|141606188|OTHER||Difference|21.6|||||TWO_SIDED|95.0|0.9|42.4|||||Difference to placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.4|0.9|
71049359|NCT02504671|141606188|OTHER||Difference|51.4|||||TWO_SIDED|95.0|31.8|70.9|||||Difference to placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||70.9|31.8|
71049360|NCT02504671|141606188|OTHER||Difference|27.0|||||TWO_SIDED|95.0|7.1|46.9|||||Difference to placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||46.9|7.1|
71049361|NCT02504671|141606188|OTHER||Difference|56.8|||||TWO_SIDED|95.0|38.2|75.4|||||Difference to placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||75.4|38.2|
71049362|NCT02504671|141606188|OTHER||Difference|27.0|||||TWO_SIDED|95.0|7.1|46.9|||||Difference to placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||46.9|7.1|
71049363|NCT02504671|141606188|OTHER||Difference|54.1|||||TWO_SIDED|95.0|35.1|73.0|||||Difference to placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||73.0|35.1|
71049364|NCT02504671|141606188|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049365|NCT02504671|141606188|OTHER||Difference|75.7|||||TWO_SIDED|95.0|61.4|89.9|||||Difference to placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||89.9|61.4|
71049366|NCT02504671|141606188|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049367|NCT02504671|141606188|OTHER||Difference|70.3|||||TWO_SIDED|95.0|55.0|85.5|||||Difference to placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||85.5|55.0|
71049368|NCT02504671|141606188|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049369|NCT02504671|141606188|OTHER||Difference|70.3|||||TWO_SIDED|95.0|55.0|85.5|||||Difference to placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||85.5|55.0|
71049370|NCT02504671|141606188|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049371|NCT02504671|141606188|OTHER||Difference|62.2|||||TWO_SIDED|95.0|45.9|78.4|||||Difference to placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||78.4|45.9|
71049372|NCT02504671|141606188|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049373|NCT02504671|141606188|OTHER||Difference|56.8|||||TWO_SIDED|95.0|40.1|73.4|||||Difference to placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||73.4|40.1|
71049374|NCT02504671|141606188|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049375|NCT02504671|141606188|OTHER||Difference|62.2|||||TWO_SIDED|95.0|45.9|78.4|||||Difference to placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||78.4|45.9|
71049376|NCT02504671|141606188|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049377|NCT02504671|141606188|OTHER||Difference|48.6|||||TWO_SIDED|95.0|31.7|65.6|||||Difference to placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||65.6|31.7|
71049378|NCT02504671|141606188|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049379|NCT02504671|141606188|OTHER||Difference|51.4|||||TWO_SIDED|95.0|34.5|68.2|||||Difference to placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||68.2|34.5|
71049380|NCT02504671|141606189|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 1, ACR20. Difference to Placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049381|NCT02504671|141606189|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Week 1, ACR20. Difference to Placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71049382|NCT02504671|141606189|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 1, ACR20. Difference to Placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71049383|NCT02504671|141606189|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 1, ACR50. Difference to Placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049384|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Week 2, ACR20. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
71049385|NCT02504671|141606189|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-5.1|21.3|||||Week 2, ACR20. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||21.3|-5.1|
71049386|NCT02504671|141606189|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-3.1|24.7|||||Week 2, ACR20. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.7|-3.1|
71049387|NCT02504671|141606189|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 2, ACR50. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049388|NCT02504671|141606189|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 2, ACR50. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049389|NCT02504671|141606189|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Week 2, ACR50. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71049390|NCT02504671|141606189|OTHER||Difference|16.2|||||TWO_SIDED|95.0|-0.2|32.6|||||Week 4, ACR20. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||32.6|-0.2|
71049391|NCT02504671|141606189|OTHER||Difference|27.0|||||TWO_SIDED|95.0|9.3|44.7|||||Week 4, ACR20. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||44.7|9.3|
71015002|NCT02203305|141537208|SUPERIORITY||||||=|0.004|||||||t-test, 2 sided|||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.||||=0.004
71015003|NCT02203305|141537209|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.||||<0.001
71015004|NCT02203305|141537209|SUPERIORITY||||||=|0.727|||||||t-test, 2 sided|||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.||||=0.727
71015005|NCT02203305|141537210|SUPERIORITY||||||=|0.001|||||||t-test, 2 sided|||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.||||=0.001
71015006|NCT02203305|141537210|SUPERIORITY||||||=|0.09|||||||t-test, 2 sided|||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.||||=0.090
71015007|NCT02203305|141537216|SUPERIORITY||||||<|0.923|||||||Mixed Models Analysis|Main effect: electrode (p\<0.001), target stimulus (p=0.923), and interval (p=0.226). Interaction: electrode and interval (p=0.496).||A linear mixed effects model compared the main effects of target stimulus (click, tone), electrode (1-5), and interval (1, 3, 6, and 12 months) on the normalized pitch match.||||<0.923
71015008|NCT02203305|141537216|OTHER||||||>|0.164|||||||bivariate pearson correlation|||Correlation between pitch perception (normalized mean pitch match) and word recognition with the CI alone.||||>0.164
71015009|NCT02203305|141537216|OTHER|bivariate pearson correlation|||||>|0.367|||||||bivariate pearson correlation|||Correlation between pitch perception (normalized mean pitch match) and speech recognition in noise (masker from the front, masker towards the better hearing ear, and masker towards the poorer hearing ear).||||>0.367
71015010|NCT02203305|141537216|OTHER|bivariate pearson correlation|||||>|0.349|||||||bivariate pearson correlation|||Correlation between pitch perception (normalized mean pitch match) and sound source localization (RMS error).||||>0.349
71015011|NCT02203305|141537217|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||"Comparison of the unaided threshold at 125 Hz at the preoperative and initial activation intervals for the 25 participants with unaided threshold of 80 dB HL or better at the preoperative interval.~The data from the SSD and AHL group were combined to review hearing preservation with long arrays. The inclusion criteria for the implanted ear were the same for the SSD and AHL groups and all subjects received the same 31.5 mm electrode array."||||<0.001
71015012|NCT02203305|141537217|SUPERIORITY||||||=|0.47|||||||ANOVA|generalized linear mixed-effects model||"Comparison of the unaided threshold at 125 Hz from the initial activation to the 12-month post-activation interval for the 9 participants with an unaided threshold of 95 dB HL or better at the initial activation interval.~The data from the SSD and AHL group were combined to review hearing preservation with long arrays. The inclusion criteria for the implanted ear were the same for the SSD and AHL groups and all subjects received the same 31.5 mm electrode array."||||=0.47
71015013|NCT02203305|141537218|SUPERIORITY||||||=|0.739|||||||t-test, 2 sided|||A paired samples t-test compared the performance with the bone-conduction device at the preoperative and 12-month intervals.||||=0.739
71015014|NCT02203305|141537218|SUPERIORITY||||||=|0.553|||||||t-test, 2 sided|||A paired samples t-test compared the performance with the bone-conduction device at the preoperative and 12-month intervals.||||=0.553
71015015|NCT02203305|141537219|SUPERIORITY||||||<|0.345||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|Main effect: interval (p=0.027) and masker condition (p\<0.001). Interaction: interval and masker condition (p=0.345).||A repeated-measures ANOVA assessed the effects of interval (preoperative and 12-months) and masker condition (front, acoustic ear, or affected ear) on performance with the bone conduction device.||||<0.345
71049392|NCT02504671|141606189|OTHER||Difference|24.3|||||TWO_SIDED|95.0|6.9|41.8|||||Week 4, ACR20. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||41.8|6.9|
71049393|NCT02504671|141606189|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Week 4, ACR50. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||10.3|-10.3|
71049394|NCT02504671|141606189|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Week 4, ACR50. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||10.3|-10.3|
71049395|NCT02504671|141606189|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-7.0|17.8|||||Week 4, ACR50. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||17.8|-7.0|
71049396|NCT02504671|141606189|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 4, ACR70. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049397|NCT02504671|141606189|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-9.3|30.9|||||Week 6, ACR20. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||30.9|-9.3|
71015016|NCT02203305|141537219|SUPERIORITY||||||<|0.577||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|Main effect: masker condition (p\<0.001) and interval (p=0.577). Interaction: interval and masker condition (p=0.055).||A repeated-measures ANOVA assessed the effects of interval (preoperative and 12-months) and masker condition (front, acoustic ear, or affected ear) on performance with the bone conduction device.||||<0.577
71015017|NCT02203305|141537220|SUPERIORITY||||||>|0.023|||||||Mixed Models Analysis|Main effect: coding strategy (p=0.023). Interaction: coding strategy and electrode (p=0.044). All other main effects and interactions were p\>0.160.||A linear mixed effect model assessed the main effects of stimulus, electrode, and coding strategy, and their interactions.||||>0.023
71015018|NCT02203305|141537220|SUPERIORITY||||||>|0.035|||||||t-test, 2 sided|Pitch perception for electrode 1 (p=0.035). All other comparisons were p\>0.318.||Paired samples t-tests evaluated whether pitch perception (mean normalized pitch) differed between coding strategy for each electrode.||||>0.035
71015019|NCT02203305|141537221|SUPERIORITY||||||>|0.084|||||||ANOVA|Main effects: condition (p=0.960) and interval (p=0.084). Interaction: condition and interval (p=0.433).||A repeated-measures ANOVA assessed the effects of condition (unaided, bone-conduction device) and interval (preoperative, 12-month) and their interaction on sound source localization.||||>0.084
71015020|NCT02203305|141537221|SUPERIORITY||||||>|0.434|||||||ANOVA|Main effect: condition (p=0.434) or interval (p=0.687). Interaction: condition and interval (p=0.678).||A repeated-measures ANOVA assessed the effects of condition (unaided, bone-conduction device) and interval (preoperative, 12-month) and their interaction on sound source localization.||||>0.434
71015021|NCT02203305|141537222|SUPERIORITY||||||<|0.935||||||Percent correct converted to rationalized arcsine units (RAU) prior to analysis.|ANOVA|Main effects: condition (p=0.018), interval (p=0.012), and masker (p\<0.001). Interactions: interval and masker (p\<0.001). Other interactions: p\>0.117.||A repeated-measures ANOVA assessed the effects of condition (unaided, bone-conduction device), interval (preoperative, 12-month), and masker condition and their 2-way and 3-way interactions on speech recognition in noise.||||<0.935
71015022|NCT02203305|141537222|SUPERIORITY||||||<|0.977||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|Effects: interval (p=0.012) and masker (p\<0.001). Interactions: interval\&masker (p=0.020) \& condition, interval, \&masker (p=0.035). Others: (p\>0.131).||A repeated-measures ANOVA assessed the effects of condition (unaided, bone-conduction device), interval (preoperative, 12-month), and masker condition and their 2-way and 3-way interactions on speech recognition in noise.||||<0.977
71015023|NCT01005810|141537242|SUPERIORITY||Odds Ratio (OR)|2.35||||0.029|TWO_SIDED|95.0|1.05|5.24|||Regression, Logistic|||||5.24|1.05|0.029
71015024|NCT00924313|141537253|SUPERIORITY||||||<|0.0001||||||The reported p-value is representative of the difference in levels of the histopathologic confirmed tumor and normal prostate tissue.|Spearman rank correlation|||||||<0.0001
71015025|NCT00924313|141537253|SUPERIORITY|||||||0.65||||||The reported p-value is representative of the BPH high uptake level.|Spearman rank correlation|||||||0.65
71015026|NCT00924313|141537256|SUPERIORITY|||||||0.55|||||||Spearman rank correlation|||||||0.55
71015027|NCT00924313|141537258|SUPERIORITY|||||||0.407|||||||Spearman rank correlation|||||||0.407
71015028|NCT00491322|141537264|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71015029|NCT00602667|141537374|OTHER||Hazard Ratio (HR)|4.99|||||TWO_SIDED|95.0|1.17|21.23||||||The historical control included 10 medulloblastoma patients treated during 1998-2006 who would have been classified as intermediate risk according to SJYC07 criteria (section 13.1.3 of protocol).||21.23|1.17|
71015030|NCT00602667|141537374|OTHER||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.4|1.84||||||The historical control included 14 medulloblastoma patients treated during 1998-2006 who would have been classified as high risk according to SJYC07 criteria (section 13.1.3 of protocol).||1.84|0.40|
71015031|NCT00602667|141537375|OTHER||Hazard Ratio (HR)|1.85|||||TWO_SIDED|95.0|0.42|8.22||||||The historical control included 10 medulloblastoma patients treated during 1998-2006 who would have been classified as intermediate risk according to SJYC07 criteria (section 13.1.3 of protocol).||8.22|0.42|
71015032|NCT00602667|141537375|OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.31|1.79||||||The historical control included 14 medulloblastoma patients treated during 1998-2006 who would have been classified as high risk according to SJYC07 criteria (section 13.1.3 of protocol).||1.79|0.31|
71015033|NCT04410978|141537463|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Relative risk|1.061||||0.6691|TWO_SIDED|95.0|0.808|1.393||Threshold for significance at 2-sided 0.05 level.|Chi-squared|||Analysis was performed using negative binomial model with number of adjudicated relapses onset between randomization date and EOS date as the response variable, treatment group, Gadolinium (Gd)-enhancing T1 lesions at baseline (presence, absence), expanded disability status scale (EDSS) strata (\<4, \>=4) and geographic region (United States \[US\], non-US) as covariates, and log transformed observation duration as the offset variable.||1.393|0.808|0.6691
71015034|NCT04410978|141537464|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Hazard Ratio (HR)|0.85||||0.4888|TWO_SIDED|95.0|0.565|1.278||Derived from log-rank test with stratification of EDSS strata (\<4, \>=4), geographic region (US, non-US).|Log Rank|||Analysis was performed using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4), geographic region (US, non-US).||1.278|0.565|0.4888
71015035|NCT04410978|141537465|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Hazard Ratio (HR)|0.819||||0.2991|TWO_SIDED|95.0|0.582|1.151||Derived from log-rank test with stratification of EDSS strata (\<4, \>=4), geographic region (US, non-US).|Log Rank|||Analysis was performed using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4), geographic region (US, non-US).||1.151|0.582|0.2991
71049398|NCT02504671|141606189|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-11.7|27.9|||||Week 6, ACR20. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||27.9|-11.7|
70850622|NCT02712047|141189438|OTHER||Mean Difference (Net)|8.29|||||TWO_SIDED|95.0|-13.99|30.57|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 12, PM|||30.57|-13.99|
71015036|NCT04410978|141537466|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Relative risk|1.084||||0.4575|TWO_SIDED|95.0|0.876|1.342|||Chi-squared|||Analysis was performed using negative binomial model with the number of new and/or enlarging T2-hyperintense lesions between randomization date and EOS date as the response variable, treatment group, baseline T2-hyperintense lesion count, EDSS strata (\<4, \>=4) and geographic region (US, non-US) as covariates, and log transformed observation duration as the offset variable.||1.342|0.876|0.4575
71015037|NCT04410978|141537467|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Relative risk|1.86||||0.0001|TWO_SIDED|95.0|1.358|2.548|||Chi-squared|||Analysis was performed using negative binomial model with the number of new Gd-enhancing T1-hyperintense lesions between randomization date and EOS date as the response variable, treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4) and geographic region (US, non-US) as covariates, and log transformed number of MRI scans as the offset variable.||2.548|1.358|0.0001
71015038|NCT04410978|141537468|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Least square (LS) mean difference|0.035||||0.432|TWO_SIDED|95.0|-0.053|0.124|||MMRM|||Covariates in the mixed-effect model with repeated measures (MMRM) were treatment group, EDSS strata (\<4, \>=4), geographic region (US, non-US), visit, treatment by visit interaction, baseline value, and baseline value-by-visit interaction.||0.124|-0.053|0.4320
71015039|NCT04410978|141537469|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS mean difference|1.873||||0.0675|TWO_SIDED|95.0|-0.135|3.88|||MMRM|||Covariates in the MMRM were treatment group, EDSS strata (\<4, \>=4), geographic region (US, non-US), visit, treatment by visit interaction, baseline value, and baseline value-by-visit interaction.||3.880|-0.135|0.0675
71015040|NCT04410978|141537470|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Hazard Ratio (HR)|0.831||||0.3594|TWO_SIDED|95.0|0.554|1.245||Derived from log-rank test with stratification of EDSS strata (\<4, \>=4), geographic region (US, non-US).|Log Rank|||Analysis was performed using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4), geographic region (US, non-US).||1.245|0.554|0.3594
71015041|NCT04410978|141537471|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS mean difference|0.196||||0.0002|TWO_SIDED|95.0|0.093|0.298|||MMRM|||Covariates in the MMRM were treatment group, EDSS strata (\<4, \>=4), geographic region (US, non-US), visit, treatment by visit interaction, cube root transformed Month 6 brain volume, and cube root transformed Month 6 brain volume-by-visit interaction.||0.298|0.093|0.0002
71015042|NCT05153629|141537481|OTHER|||||||0.93||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of back pain.||||0.93
71015043|NCT05153629|141537481|OTHER|||||||0.76||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of abdominal/groin pain.||||0.76
71015044|NCT05153629|141537481|OTHER|||||||0.56||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of pain frequency.||||0.56
71015045|NCT05153629|141537481|OTHER|||||||0.26||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of nausea intensity.||||0.26
71015046|NCT05153629|141537482|OTHER|||||||0.55||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of difference in back pain.||||0.55
71015047|NCT05153629|141537482|OTHER|||||||0.28||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of difference in abdominal/groin pain.||||0.28
71015048|NCT05153629|141537482|OTHER|||||||0.39||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of difference in pain frequency.||||0.39
71015049|NCT05153629|141537482|OTHER|||||||0.26||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of difference in nausea intensity.||||0.26
71015050|NCT05153629|141537483|OTHER|||||||0.5||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||||||0.50
71015051|NCT05153629|141537484|OTHER|||||||0.5||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||||||0.50
71104552|NCT03274466|141716540|SUPERIORITY|Modified Intent-To-Treat|Odds Ratio (OR)|0.33||||0.168|TWO_SIDED|95.0|0.07|1.7||Threshold for Statistical Significance: alpha = 0.048|Cochran-Mantel-Haenszel|||||1.70|0.07|0.1680
71015052|NCT05153629|141537485|OTHER|||||||0.8||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of overall USDT score.||||0.80
71015053|NCT05153629|141537485|OTHER|||||||0.72||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of urinary symptoms.||||0.72
71015054|NCT05153629|141537485|OTHER|||||||0.45||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of pain.||||0.45
71104553|NCT03274466|141716541|SUPERIORITY|Modified Intent-To-Treat|Odds Ratio (OR)|0.34||||0.3386|TWO_SIDED|95.0|0.04|3.39||Threshold for Statistical Significance: alpha = 0.048|Cochran-Mantel-Haenszel|||||3.39|0.04|0.3386
71104554|NCT03274466|141716542|SUPERIORITY||Odds Ratio (OR)|0.22||||0.0013|TWO_SIDED|95.0|0.08|0.59||Threshold for statistical significance: alpha = 0.048|Cochran-Mantel-Haenszel|||Sensitivity analysis of the Primary Endpoint using the Intent-To-Treat population.||0.59|0.08|0.0013
71104555|NCT02989857|141716559|SUPERIORITY||Hazard Ratio (HR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.25|0.54||P-value was calculated from the one-sided stratified log-rank test.|Log Rank||Hazard ratio was calculated from stratified Cox regression model with placebo as the denominator, with two-sided 95% confidence interval.|||0.54|0.25|<0.0001
71015055|NCT05153629|141537485|OTHER|||||||0.42||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of daily life.||||0.42
70929947|NCT02938923|141357386|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.608|TWO_SIDED|95.0|-0.53|0.91||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.51|Difference between the IADL changes (EX+T - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.91|-0.53|0.608
71015056|NCT05153629|141537485|OTHER|||||||0.36||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of sexual life.||||0.36
71015057|NCT05153629|141537485|OTHER|||||||0.49||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of medical care/analgesic use.||||0.49
70929948|NCT02938923|141357386|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.915|TWO_SIDED|95.0|-0.76|0.69||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.11|Difference between the IADL changes (EX+P - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.69|-0.76|0.915
71015058|NCT05153629|141537485|OTHER|||||||0.88||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of overall quality of life.||||0.88
71015059|NCT00972309|141537496|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71015060|NCT01233284|141537500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.09|0.186|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.186|0.090|<0.0001
71015061|NCT01233284|141537500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.08|0.176|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.176|0.080|<0.0001
71015062|NCT01233284|141537500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.14|0.236|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.236|0.140|<0.0001
71015063|NCT01233284|141537501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.078|0.173|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.173|0.078|<0.0001
71015064|NCT01233284|141537501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.084|0.179|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.179|0.084|<0.0001
71015065|NCT01233284|141537501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.096|0.191|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.191|0.096|<0.0001
71015066|NCT01233284|141537502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.083|0.175|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.175|0.083|<0.0001
71015067|NCT01233284|141537502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.081|0.172|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.172|0.081|<0.0001
71015068|NCT01233284|141537502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.132|0.224|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.224|0.132|<0.0001
71015069|NCT01233284|141537503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.027||0.0034||95.0|0.026|0.132|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.132|0.026|0.0034
71015070|NCT01233284|141537503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.071|STANDARD_ERROR_OF_MEAN|0.027||0.0087||95.0|0.018|0.124|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.124|0.018|0.0087
71015071|NCT01233284|141537503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.085|0.19|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.190|0.085|<0.0001
71015072|NCT01233284|141537504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.03||0.0732||95.0|-0.005|0.113|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.113|-0.005|0.0732
71015073|NCT01233284|141537504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.072|STANDARD_ERROR_OF_MEAN|0.03||0.0177||95.0|0.012|0.131|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.131|0.012|0.0177
71015074|NCT01233284|141537504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.03||0.0012||95.0|0.039|0.157|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.157|0.039|0.0012
71015075|NCT01233284|141537505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064|STANDARD_ERROR_OF_MEAN|0.026||0.0149||95.0|0.013|0.115|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.115|0.013|0.0149
71049399|NCT02504671|141606189|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-9.3|30.9|||||Week 6, ACR20. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||30.9|-9.3|
71049400|NCT02504671|141606189|OTHER||Difference|-5.4|||||TWO_SIDED|95.0|-17.8|7.0|||||Week 6, ACR50. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.0|-17.8|
71049401|NCT02504671|141606189|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-16.0|10.6|||||Week 6, ACR50. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||10.6|-16.0|
71049402|NCT02504671|141606189|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-14.1|14.1|||||Week 6, ACR50. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||14.1|-14.1|
71015076|NCT01233284|141537505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|0.026||0.0043||95.0|0.024|0.126|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.126|0.024|0.0043
71015077|NCT01233284|141537505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.086|0.189|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.189|0.086|<0.0001
71015078|NCT01233284|141537509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.55|STANDARD_ERROR_OF_MEAN|3.737|<|0.0001||95.0|11.204|25.895|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||25.895|11.204|<0.0001
71015079|NCT01233284|141537509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.895|STANDARD_ERROR_OF_MEAN|3.737|<|0.0001||95.0|10.55|25.24|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||25.240|10.550|<0.0001
71015080|NCT01233284|141537509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.846|STANDARD_ERROR_OF_MEAN|3.739|<|0.0001||95.0|13.497|28.195|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||28.195|13.497|<0.0001
71015081|NCT01233284|141537510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.251|STANDARD_ERROR_OF_MEAN|3.77|<|0.0001||95.0|13.84|28.662|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||28.662|13.840|<0.0001
71015082|NCT01233284|141537510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.577|STANDARD_ERROR_OF_MEAN|3.77||0.0001||95.0|7.166|21.988|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||21.988|7.166|0.0001
71049403|NCT02504671|141606189|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 6, ACR70. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71015083|NCT01233284|141537510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.581|STANDARD_ERROR_OF_MEAN|3.773|<|0.0001||95.0|14.166|28.997|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||28.997|14.166|<0.0001
71049404|NCT02504671|141606189|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 6, ACR70. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049405|NCT02504671|141606189|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-10.1|26.3|||||Week 8, ACR20. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.3|-10.1|
71049406|NCT02504671|141606189|OTHER||Difference|24.3|||||TWO_SIDED|95.0|4.5|44.1|||||Week 8, ACR20. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||44.1|4.5|
71049407|NCT02504671|141606189|OTHER||Difference|29.7|||||TWO_SIDED|95.0|9.8|49.7|||||Week 8, ACR20. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||49.7|9.8|
71049408|NCT02504671|141606189|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 8, ACR50. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
71015084|NCT01233284|141537511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.114|STANDARD_ERROR_OF_MEAN|0.635||0.8574||95.0|-1.363|1.134|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||1.134|-1.363|0.8574
71015085|NCT01233284|141537511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.635||0.3954||95.0|-1.789|0.708|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.708|-1.789|0.3954
71015086|NCT01233284|141537511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.077|STANDARD_ERROR_OF_MEAN|0.636||0.9034||95.0|-1.327|1.173|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||1.173|-1.327|0.9034
71015087|NCT01233284|141537512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.233|STANDARD_ERROR_OF_MEAN|0.107||0.0296||95.0|-0.443|-0.023|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||-0.023|-0.443|0.0296
71015088|NCT01233284|141537512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.214|STANDARD_ERROR_OF_MEAN|0.107||0.0454||95.0|-0.424|-0.004|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||-0.004|-0.424|0.0454
71015089|NCT01233284|141537512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.201|STANDARD_ERROR_OF_MEAN|0.107||0.061||95.0|-0.41|0.009|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.009|-0.410|0.0610
71015090|NCT01233284|141537513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.149|STANDARD_ERROR_OF_MEAN|0.063||0.0183||95.0|-0.273|-0.025|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||-0.025|-0.273|0.0183
71015091|NCT01233284|141537513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.138|STANDARD_ERROR_OF_MEAN|0.063||0.0288||95.0|-0.262|-0.014|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||-0.014|-0.262|0.0288
71049409|NCT02504671|141606189|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 8, ACR50. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71049410|NCT02504671|141606189|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 8, ACR50. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71049411|NCT02504671|141606189|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Week 8, ACR70. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
71049412|NCT02504671|141606189|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Week 8, ACR70. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
71049413|NCT02504671|141606189|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 8, ACR70. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
71049414|NCT02504671|141606189|OTHER||Difference|24.3|||||TWO_SIDED|95.0|6.0|42.7|||||Week 12, ACR20. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.7|6.0|
71049415|NCT02504671|141606189|OTHER||Difference|29.7|||||TWO_SIDED|95.0|11.0|48.4|||||Week 12, ACR20. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.4|11.0|
71049416|NCT02504671|141606189|OTHER||Difference|40.5|||||TWO_SIDED|95.0|21.6|59.5|||||Week 12, ACR20. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||59.5|21.6|
71049417|NCT02504671|141606189|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-10.6|16.0|||||Week 12, ACR50. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.0|-10.6|
71049418|NCT02504671|141606189|OTHER||Difference|18.9|||||TWO_SIDED|95.0|2.1|35.7|||||Week 12, ACR50. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||35.7|2.1|
71049419|NCT02504671|141606189|OTHER||Difference|16.2|||||TWO_SIDED|95.0|-0.2|32.6|||||Week 12, ACR50. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||32.6|-0.2|
71049420|NCT02504671|141606189|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-11.7|6.3|||||Week 12, ACR70. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||6.3|-11.7|
71049421|NCT02504671|141606189|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-5.1|21.3|||||Week 12, ACR70. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||21.3|-5.1|
71049422|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Week 12, ACR70. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
71049423|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-5.4|32.4|||||Week 16, ACR20. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||32.4|-5.4|
71049424|NCT02504671|141606189|OTHER||Difference|29.7|||||TWO_SIDED|95.0|9.8|49.7|||||Week 16, ACR20. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||49.7|9.8|
71049425|NCT02504671|141606189|OTHER||Difference|35.1|||||TWO_SIDED|95.0|15.1|55.1|||||Week 16, ACR20. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||55.1|15.1|
71049426|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-2.4|29.4|||||Week 16, ACR50. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.4|-2.4|
71049427|NCT02504671|141606189|OTHER||Difference|18.9|||||TWO_SIDED|95.0|2.1|35.7|||||Week 16, ACR50. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||35.7|2.1|
71049428|NCT02504671|141606189|OTHER||Difference|18.9|||||TWO_SIDED|95.0|2.1|35.7|||||Week 16, ACR50. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||35.7|2.1|
70929949|NCT02938923|141357387|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.602|TWO_SIDED|95.0|-1.36|2.33||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = 0.52|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure.||2.33|-1.36|0.602
70929950|NCT02938923|141357387|SUPERIORITY||Mean Difference (Final Values)|-0.96||||0.454|TWO_SIDED|95.0|-3.48|1.56||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -0.75|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure.||1.56|-3.48|0.454
70929951|NCT02938923|141357387|SUPERIORITY||Mean Difference (Final Values)|-1.45||||0.262|TWO_SIDED|95.0|-3.98|1.09||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -1.13|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure.||1.09|-3.98|0.262
70929952|NCT02938923|141357387|SUPERIORITY||Mean Difference (Final Values)|0.46||||0.639|TWO_SIDED|95.0|-1.47|2.4||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = 0.47|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||2.40|-1.47|0.639
70929953|NCT02938923|141357387|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.438|TWO_SIDED|95.0|-3.66|1.59||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -0.78|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||1.59|-3.66|0.438
70929954|NCT02938923|141357387|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.265|TWO_SIDED|95.0|-4.14|1.14||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -1.12|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||1.14|-4.14|0.265
70929955|NCT02938923|141357387|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.555|TWO_SIDED|95.0|-1.11|2.07||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = 0.59|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure.||2.07|-1.11|0.555
70929956|NCT02938923|141357387|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.917|TWO_SIDED|95.0|-2.39|2.15||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -0.10|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure.||2.15|-2.39|0.917
70929957|NCT02938923|141357387|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.606|TWO_SIDED|95.0|-2.87|1.68||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -0.52|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure.||1.68|-2.87|0.606
70929958|NCT02938923|141357387|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.549|TWO_SIDED|95.0|-1.09|2.04||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = 0.60|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||2.04|-1.09|0.549
70929959|NCT02938923|141357387|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.887|TWO_SIDED|95.0|-2.38|2.06||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -0.14|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||2.06|-2.38|0.887
70929960|NCT02938923|141357387|SUPERIORITY||Mean Difference (Final Values)|-0.64||||0.574|TWO_SIDED|95.0|-2.87|1.59||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -0.56|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||1.59|-2.87|0.574
70929961|NCT02938923|141357388|SUPERIORITY||Mean Difference (Final Values)|0.96||||0.649|TWO_SIDED|95.0|-3.19|5.11||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.46|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Compound Symmetry covariance structure.||5.11|-3.19|0.649
70929962|NCT02938923|141357388|SUPERIORITY||Mean Difference (Final Values)|2.5||||0.389|TWO_SIDED|95.0|-3.22|8.23||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.86|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Compound Symmetry covariance structure.||8.23|-3.22|0.389
71015092|NCT01233284|141537513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.111|STANDARD_ERROR_OF_MEAN|0.063||0.0781||95.0|-0.235|0.013|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.013|-0.235|0.0781
71015093|NCT01233284|141537514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.084|STANDARD_ERROR_OF_MEAN|0.055||0.1303||95.0|-0.193|0.025|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.025|-0.193|0.1303
71015094|NCT01233284|141537514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.068|STANDARD_ERROR_OF_MEAN|0.055||0.2191||95.0|-0.177|0.041|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.041|-0.177|0.2191
71015095|NCT01233284|141537514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.087|STANDARD_ERROR_OF_MEAN|0.056||0.1163||95.0|-0.196|0.022|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.022|-0.196|0.1163
71015096|NCT01233284|141537515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.032||0.7501||95.0|-0.073|0.052|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.052|-0.073|0.7501
71015097|NCT01233284|141537515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.032||0.8401||95.0|-0.069|0.056|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.056|-0.069|0.8401
71015098|NCT01233284|141537515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.031|STANDARD_ERROR_OF_MEAN|0.032||0.3237||95.0|-0.094|0.031|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.031|-0.094|0.3237
71015099|NCT01233284|141537516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.079||0.1402|TWO_SIDED|95.0|-0.04|0.276||MMRM, adjusted for treatment, period, patient and study baseline.|Mixed Models Analysis||Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC0-12h||0.276|-0.040|0.1402
71015100|NCT01233284|141537516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.079||0.0656|TWO_SIDED|95.0|-0.01|0.305|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC0-12h||0.305|-0.010|0.0656
71049429|NCT02504671|141606189|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-11.7|6.3|||||Week 16, ACR70. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||6.3|-11.7|
71104556|NCT02989857|141716566|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.093|TWO_SIDED|95.0|0.56|1.12||P-value was calculated from the one-sided stratified log-rank test. Stratification factor was the number of prior line of therapies at randomization.|Log Rank||Hazard ratio was calculated from the stratified Cox regression model with placebo as the comparator, with two-sided 95% CI. Stratification factor was the number of prior line of therapies at randomization.|||1.12|0.56|0.093
71015101|NCT01233284|141537516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|STANDARD_ERROR_OF_MEAN|0.079||0.0766|TWO_SIDED|95.0|-0.015|0.299|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC0-12h||0.299|-0.015|0.0766
71015102|NCT01233284|141537516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.084||0.3371|TWO_SIDED|95.0|-0.086|0.249|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC12-24h||0.249|-0.086|0.3371
71049430|NCT02504671|141606189|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-5.1|21.3|||||Week 16, ACR70. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||21.3|-5.1|
71049431|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Week 16, ACR70. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
71049432|NCT02504671|141606189|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-10.1|26.3|||||Week 20, ACR20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.3|-10.1|
71049433|NCT02504671|141606189|OTHER||Difference|21.6|||||TWO_SIDED|95.0|2.0|41.2|||||Week 20, ACR20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||41.2|2.0|
71015103|NCT01233284|141537516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.084||0.1097|TWO_SIDED|95.0|-0.031|0.303|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC12-24h||0.303|-0.031|0.1097
71015104|NCT01233284|141537516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.196|STANDARD_ERROR_OF_MEAN|0.084||0.022|TWO_SIDED|95.0|0.029|0.363|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC12-24h||0.363|0.029|0.0220
71015105|NCT01233284|141537516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.078||0.2062|TWO_SIDED|95.0|-0.056|0.256|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC0-24h||0.256|-0.056|0.2062
71015106|NCT01233284|141537516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|STANDARD_ERROR_OF_MEAN|0.078||0.0731|TWO_SIDED|95.0|-0.014|0.297|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC0-24h||0.297|-0.014|0.0731
71015107|NCT01233284|141537516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.078||0.0333|TWO_SIDED|95.0|0.014|0.324|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC0-24h||0.324|0.014|0.0333
71049434|NCT02504671|141606189|OTHER||Difference|37.8|||||TWO_SIDED|95.0|17.9|57.8|||||Week 20, ACR20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||57.8|17.9|
71049435|NCT02504671|141606189|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-10.6|16.0|||||Week 20, ACR50. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.0|-10.6|
71049436|NCT02504671|141606189|OTHER||Difference|16.2|||||TWO_SIDED|95.0|-0.2|32.6|||||Week 20, ACR50. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||32.6|-0.2|
71049437|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-2.4|29.4|||||Week 20, ACR50. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.4|-2.4|
71049438|NCT02504671|141606189|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-11.7|6.3|||||Week 20, ACR70. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||6.3|-11.7|
71049439|NCT02504671|141606189|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-3.1|24.7|||||Week 20, ACR70. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.7|-3.1|
71104557|NCT02989857|141716567|SUPERIORITY|||||||0.466||||||P-value was calculated from 1-sided Fisher exact test.|Fisher Exact|||||||0.466
71104558|NCT02989857|141716568|SUPERIORITY|||||||0.299||||||P-value was calculated from 1-sided Fisher exact test.|Fisher Exact|||||||0.299
71104559|NCT02989857|141716573|SUPERIORITY||Hazard Ratio (HR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.33|0.68||P-value was calculated from one-sided stratified log-rank test. Stratification factor was the number of prior line of therapies at randomization.|Log Rank||Hazard ratio was calculated from the stratified Cox regression model with placebo as the denominator, with two-sided 95% CI. Stratification factor was the number of prior line of therapies at randomization.|||0.68|0.33|<0.0001
71104560|NCT02989857|141716574|OTHER||Least-squares mean difference|11.0|||||TWO_SIDED|95.0|4.23|17.73||||||Cycle 2 Day 1: Physical Functioning||17.73|4.23|
71104561|NCT02989857|141716574|OTHER||Least-squares mean difference|-10.4|||||TWO_SIDED|95.0|-20.18|-0.52||||||Cycle 2 Day 1: Pain||-0.52|-20.18|
71104562|NCT02989857|141716574|OTHER||Least-squares mean difference|3.6|||||TWO_SIDED|95.0|-6.65|13.91||||||Cycle 2 Day 1: Appetite Loss||13.91|-6.65|
71015108|NCT01233284|141537517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.116|STANDARD_ERROR_OF_MEAN|0.099||0.2451|TWO_SIDED|95.0|-0.081|0.312|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC0-12h||0.312|-0.081|0.2451
71015109|NCT01233284|141537517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.099||0.0379|TWO_SIDED|95.0|0.012|0.405|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC0-12h||0.405|0.012|0.0379
70850623|NCT02712047|141189438|OTHER||Mean Difference (Net)|0.64|||||TWO_SIDED|95.0|-21.64|22.92|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 13, AM|||22.92|-21.64|
71015110|NCT01233284|141537517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|STANDARD_ERROR_OF_MEAN|0.099||0.0957|TWO_SIDED|95.0|-0.03|0.363|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC0-12h||0.363|-0.030|0.0957
71015111|NCT01233284|141537517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.067|STANDARD_ERROR_OF_MEAN|0.104||0.5207|TWO_SIDED|95.0|-0.139|0.273|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC12-24h||0.273|-0.139|0.5207
71015112|NCT01233284|141537517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|STANDARD_ERROR_OF_MEAN|0.104||0.0606|TWO_SIDED|95.0|-0.009|0.404|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC12-24h||0.404|-0.009|0.0606
71015113|NCT01233284|141537517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.181|STANDARD_ERROR_OF_MEAN|0.104||0.0855|TWO_SIDED|95.0|-0.026|0.387|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC12-24h||0.387|-0.026|0.0855
71015114|NCT01233284|141537517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.099||0.3564|TWO_SIDED|95.0|-0.104|0.287|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC0-24h||0.287|-0.104|0.3564
71015115|NCT01233284|141537517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.099||0.0424|TWO_SIDED|95.0|0.007|0.399|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC0-24h||0.399|0.007|0.0424
71015116|NCT01233284|141537517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.099||0.0815|TWO_SIDED|95.0|-0.022|0.37|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC0-24h||0.370|-0.022|0.0815
71015117|NCT05405218|141537518|SUPERIORITY||Mean Difference (Net)|0.08||||0.46|TWO_SIDED|95.0|-0.13|0.29|||Mixed Models Analysis|||||0.29|-0.13|0.46
71015118|NCT05405218|141537519|SUPERIORITY||Mean Difference (Net)|0.01||||0.92|TWO_SIDED|95.0|-0.2|0.23|||Mixed Models Analysis|||||0.23|-0.2|0.92
71015119|NCT05405218|141537521|SUPERIORITY||Mean Difference (Net)|0.61||||0.09|TWO_SIDED|95.0|-0.08|1.3|||Mixed Models Analysis|||||1.3|-0.08|0.09
71015120|NCT05405218|141537522|SUPERIORITY||Mean Difference (Net)|0.0||||0.9|TWO_SIDED|95.0|-0.06|0.05|||Mixed Models Analysis|||||0.05|-0.06|0.9
71015121|NCT05436067|141537558|OTHER||||||<|0.001||||||Difference in head angle pitch - left between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||<0.001
71015122|NCT05436067|141537558|OTHER||||||<|0.001||||||Difference in head angle pitch - right between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||<0.001
71015123|NCT05436067|141537558|OTHER|||||||0.042||||||Difference in head angle yaw - extension between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||0.042
71015124|NCT05436067|141537558|OTHER|||||||0.111||||||Difference in head angle yaw - flexion between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||0.111
71015125|NCT05436067|141537559|OTHER|||||||0.023||||||Difference in pitch range of motion between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||0.023
71015126|NCT05436067|141537559|OTHER||||||<|0.001|||||||paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||<0.001
71015127|NCT05436067|141537560|OTHER|||||||0.057||||||Difference in pitch velocity between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||0.057
71015128|NCT05436067|141537560|OTHER|||||||0.003||||||Difference in yaw velocity between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||0.003
71015129|NCT05436067|141537561|OTHER|||||||0.035||||||Weight shift exercise - mediolateral range of motion|paired t-test|||||||0.035
71015130|NCT05436067|141537561|OTHER|||||||0.006||||||Weight shift balance exercise anteroposterior range of motion|paired t-test|||||||0.006
71015131|NCT05436067|141537561|OTHER|||||||0.024||||||Single leg balance range of motion|paired t-test|||||||0.024
71015132|NCT05436067|141537561|OTHER|||||||0.257||||||Single leg balance fluency|Shapiro Wilcoxon test|Data was not normally distributed.||||||0.257
71015133|NCT00157820|141537569|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.31||||0.0028|TWO_SIDED|95.0|0.14|0.67|||Wilcoxon (Mann-Whitney)||An additional primary analysis was pre-planned: the odds ratio of CSAE-score between DC and SC obtained from SAS GENMOD procedure with the length of follow-up as an 'offset'.|"The assumed effect of the DC treatment was a reduction from 30 to 15% in the proportion of patients who develop a CSAE, as well as a 15% reduction in the mean of CSAE (from 6 to 5.1). The estimated sample size was 200 (DC true) vs. 100 (SC true) patients followed for 8 months, with a two-sided alfa \< 0.05 and a power of 88.8%.~The sample size was set up to 360 patients (120 patients per arm), considering losses in follow-up."||0.67|0.14|0.0028
71015134|NCT00563706|141537586|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-12.3||||0.043|TWO_SIDED|95.0|-24.24|-0.37|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||-0.37|-24.24|0.043
71015135|NCT00563706|141537586|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.77||||0.457|TWO_SIDED|95.0|-24.7|11.16|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||11.16|-24.70|0.457
71015136|NCT00563706|141537586|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.61||||0.067|TWO_SIDED|95.0|-24.03|0.81|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||0.81|-24.03|0.067
71015137|NCT00563706|141537586|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.61||||0.567|TWO_SIDED|95.0|-16.02|8.8|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||8.80|-16.02|0.567
71015138|NCT00563706|141537586|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.9||||0.07|TWO_SIDED|95.0|-22.71|0.92|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||0.92|-22.71|0.070
71015139|NCT00563706|141537586|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.18||||0.647|TWO_SIDED|95.0|-16.87|10.5|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||10.50|-16.87|0.647
71015140|NCT00563706|141537586|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.73||||0.075|TWO_SIDED|95.0|-20.46|1.0|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||1.00|-20.46|0.075
71015141|NCT00563706|141537586|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.44||||0.765|TWO_SIDED|95.0|-10.92|8.04|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||8.04|-10.92|0.765
71015142|NCT00299546|141537595|SUPERIORITY_OR_OTHER||||||<|0.001||||||A positive test is concluded if there is a significant difference between combined golimumab and placebo groups and at least one of the pair-wise comparisons at 0.05 level.|Cochran-Mantel-Haenszel|Stratified by baseline Methotrexate (MTX)||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Group 1 vs. Combined Groups 2 and 3. A sample size of 140 patients per group provides a \>90% power assuming 50% of patients used Methotrexate (MTX) at baseline and 30% ACR 20 response in placebo and 40\~55% ACR 20 response in golimumab groups.||||<0.001
71015143|NCT00299546|141537595|SUPERIORITY_OR_OTHER|||||||0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX||Null Hypothesis: No difference in ACR 20 response at Wk 14 between Group 1: Placebo and Group 2: 50 mg.||||0.001
71015144|NCT00299546|141537595|SUPERIORITY_OR_OTHER||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||Null Hypothesis: No difference in ACR 20 response at Wk 14 between Group 1: Placebo and Group 3 :100 mg.||||<0.001
71015145|NCT00299546|141537596|SUPERIORITY_OR_OTHER|||||||0.003|||||||Cochran-Mantel-Haenszel|Stratified by baseline Methotrexate (MTX).||||||0.003
71015146|NCT00299546|141537596|SUPERIORITY_OR_OTHER|||||||0.021||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||||||0.021
71015147|NCT00299546|141537596|SUPERIORITY_OR_OTHER|||||||0.002||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||||||0.002
71015148|NCT00299546|141537597|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline Methorexate (MTX).||||||<0.001
71015149|NCT00299546|141537597|SUPERIORITY_OR_OTHER||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||||||<0.001
71015150|NCT00299546|141537597|SUPERIORITY_OR_OTHER||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||||||<0.001
71015151|NCT00299546|141537598|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline Methotrexate (MTX).||||||<0.001
71015152|NCT00299546|141537598|SUPERIORITY_OR_OTHER|||||||0.002||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||||||0.002
71015153|NCT00299546|141537598|SUPERIORITY_OR_OTHER||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||||||<0.001
71015154|NCT00299546|141537599|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on van der Waerden normal scores.|Stratified by baseline Methotrexate (MTX).||||||<0.001
71015155|NCT00299546|141537599|SUPERIORITY_OR_OTHER||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|ANOVA on van der Waerden normal scores.|Stratified by baseline MTX.||||||<0.001
71015156|NCT00299546|141537599|SUPERIORITY_OR_OTHER||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|ANOVA on van der Waerden normal scores.|Stratified by baseline MTX.||||||<0.001
71049440|NCT02504671|141606189|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-5.1|21.3|||||Week 20, ACR70. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||21.3|-5.1|
71049441|NCT02504671|141606189|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-6.9|28.5|||||Week 24, ACR20. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.5|-6.9|
71049442|NCT02504671|141606189|OTHER||Difference|27.0|||||TWO_SIDED|95.0|7.7|46.3|||||Week 24, ACR20. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||46.3|7.7|
71049443|NCT02504671|141606189|OTHER||Difference|43.2|||||TWO_SIDED|95.0|23.8|62.6|||||Week 24, ACR20. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||62.6|23.8|
70929963|NCT02938923|141357388|SUPERIORITY||Mean Difference (Final Values)|1.55||||0.598|TWO_SIDED|95.0|-4.22|7.31||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.53|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Compound Symmetry covariance structure.||7.31|-4.22|0.598
70929964|NCT02938923|141357388|SUPERIORITY||Mean Difference (Final Values)|0.88||||0.676|TWO_SIDED|95.0|-3.26|5.02||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.42|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Compound Symmetry covariance structure in the model with covariates.||5.02|-3.26|0.676
70929965|NCT02938923|141357388|SUPERIORITY||Mean Difference (Final Values)|2.48||||0.394|TWO_SIDED|95.0|-3.24|8.19||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.85|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Compound Symmetry covariance structure in the model with covariates.||8.19|-3.24|0.394
70929966|NCT02938923|141357388|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.585|TWO_SIDED|95.0|-4.15|7.35||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.55|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Compound Symmetry covariance structure in the model with covariates.||7.35|-4.15|0.585
70929967|NCT02938923|141357388|SUPERIORITY||Mean Difference (Final Values)|0.55||||0.794|TWO_SIDED|95.0|-3.56|4.65||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.26|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Compound Symmetry covariance structure.||4.65|-3.56|0.794
70929968|NCT02938923|141357388|SUPERIORITY||Mean Difference (Final Values)|2.27||||0.449|TWO_SIDED|95.0|-3.62|8.16||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.76|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Compound Symmetry covariance structure.||8.16|-3.62|0.449
70929969|NCT02938923|141357388|SUPERIORITY||Mean Difference (Final Values)|1.72||||0.567|TWO_SIDED|95.0|-4.2|7.64||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.57|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Compound Symmetry covariance structure.||7.64|-4.20|0.567
70929970|NCT02938923|141357388|SUPERIORITY||Mean Difference (Final Values)|0.55||||0.794|TWO_SIDED|95.0|-3.56|4.65||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.26|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Compound Symmetry covariance structure in the model with covariates.||4.65|-3.56|0.794
70929971|NCT02938923|141357388|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.526|TWO_SIDED|95.0|-3.97|7.75||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.64|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Compound Symmetry covariance structure in the model with covariates.||7.75|-3.97|0.526
70929972|NCT02938923|141357388|SUPERIORITY||Mean Difference (Final Values)|1.34||||0.654|TWO_SIDED|95.0|-4.55|7.23||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.45|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Compound Symmetry covariance structure in the model with covariates.||7.23|-4.55|0.654
70929973|NCT02938923|141357389|SUPERIORITY||Mean Difference (Final Values)|0.63||||0.597|TWO_SIDED|95.0|-1.72|2.98||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.53|Difference between the changes (EX+T - EX+P) on Physical Health domain|Comparison of Physical Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure.||2.98|-1.72|0.597
70929974|NCT02938923|141357389|SUPERIORITY||Mean Difference (Final Values)|-2.18||||0.184|TWO_SIDED|95.0|-5.41|1.04||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -1.33|Difference between the changes (EX+T - EUC) on Physical Health domain|Comparison of Physical Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure.||1.04|-5.41|0.184
70929975|NCT02938923|141357389|SUPERIORITY||Mean Difference (Final Values)|-2.82||||0.089|TWO_SIDED|95.0|-6.07|0.44||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -1.71|Difference between the changes (EX+P - EUC) on Physical Health domain|Comparison of Physical Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure.||0.44|-6.07|0.089
70929976|NCT02938923|141357389|SUPERIORITY||Mean Difference (Final Values)|0.64||||0.635|TWO_SIDED|95.0|-2.01|3.28||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.47|Difference in the changes (EX+T - EX+P)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||3.28|-2.01|0.635
70929977|NCT02938923|141357389|SUPERIORITY||Mean Difference (Final Values)|-2.15||||0.242|TWO_SIDED|95.0|-5.76|1.46||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -1.17|Difference between the changes (EX+T - EUC)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||1.46|-5.76|0.242
70929978|NCT02938923|141357389|SUPERIORITY||Mean Difference (Final Values)|-2.79||||0.132|TWO_SIDED|95.0|-6.42|0.85||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -1.51|Difference between the changes (EX+P - EUC)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||0.85|-6.42|0.132
70929979|NCT02938923|141357389|SUPERIORITY||Mean Difference (Final Values)|1.52||||0.193|TWO_SIDED|95.0|-0.77|3.81||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 1.31|Difference between the changes (EX+T - EX+P)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure.||3.81|-0.77|0.193
71049444|NCT02504671|141606189|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-14.1|14.1|||||Week 24, ACR50. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||14.1|-14.1|
70929980|NCT02938923|141357389|SUPERIORITY||Mean Difference (Final Values)|1.44||||0.39|TWO_SIDED|95.0|-1.86|4.75||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.86|Difference between the changes (EX+T - EUC)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure.||4.75|-1.86|0.390
70929981|NCT02938923|141357389|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.965|TWO_SIDED|95.0|-3.39|3.25||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.04|Difference between the changes (EX+P - EUC)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure.||3.25|-3.39|0.965
70929982|NCT02938923|141357389|SUPERIORITY||Mean Difference (Final Values)|1.52||||0.195|TWO_SIDED|95.0|-0.79|3.82||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 1.30|Difference between the changes (EX+T - EX+P)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||3.82|-0.79|0.195
70929983|NCT02938923|141357389|SUPERIORITY||Mean Difference (Final Values)|1.35||||0.418|TWO_SIDED|95.0|-1.93|4.63||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.81|Difference between the changes (EX+T - EUC)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||4.63|-1.93|0.418
70929984|NCT02938923|141357389|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.921|TWO_SIDED|95.0|-3.46|3.13||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.10|Difference between the changes (EX+P - EUC)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||3.13|-3.46|0.921
70929985|NCT02938923|141357389|SUPERIORITY||Mean Difference (Final Values)|2.31||||0.078|TWO_SIDED|95.0|-0.26|4.88||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = 1.77|Difference between the changes (EX+T - EX+P)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure.||4.88|-0.26|0.078
70929986|NCT02938923|141357389|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.982|TWO_SIDED|95.0|-3.51|3.43||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -0.02|Difference between the changes (EX+T - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure.||3.43|-3.51|0.982
70929987|NCT02938923|141357389|SUPERIORITY||Mean Difference (Final Values)|-2.35||||0.187|TWO_SIDED|95.0|-5.85|1.15||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -1.32|Difference between the changes (EX+P - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure.||1.15|-5.85|0.187
70929988|NCT02938923|141357389|SUPERIORITY||Mean Difference (Final Values)|2.16||||0.08|TWO_SIDED|95.0|-0.26|4.58||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = 1.76|Difference of the changes (EX+T - EX+P)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure in the model with covariates.||4.58|-0.26|0.080
70929989|NCT02938923|141357389|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.781|TWO_SIDED|95.0|-3.76|2.83||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -0.28|Difference between the changes (EX+T - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure in the model with covariates.||2.83|-3.76|0.781
70929990|NCT02938923|141357389|SUPERIORITY||Mean Difference (Final Values)|-2.63||||0.121|TWO_SIDED|95.0|-5.94|0.69||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -1.56|Difference between the changes (EX+P - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure in the model with covariates.||0.69|-5.94|0.121
70929991|NCT02938923|141357389|SUPERIORITY||Mean Difference (Final Values)|1.58||||0.148|TWO_SIDED|95.0|-0.57|3.73||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = 1.45|Difference between the changes (EX+T - EX+P)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure.||3.73|-0.57|0.148
71049445|NCT02504671|141606189|OTHER||Difference|16.2|||||TWO_SIDED|95.0|-1.2|33.7|||||Week 24, ACR50. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.7|-1.2|
71104563|NCT02989857|141716574|OTHER||Least-squares mean difference|12.3|||||TWO_SIDED|95.0|3.85|20.78||||||Cycle 3 Day 1: Physical Functioning||20.78|3.85|
71104564|NCT02989857|141716574|OTHER||Least-squares mean difference|4.1|||||TWO_SIDED|95.0|-8.74|17.04||||||Cycle 3 Day 1: Pain||17.04|-8.74|
71104565|NCT02989857|141716574|OTHER||Least-squares mean difference|-3.7|||||TWO_SIDED|95.0|-17.46|10.11||||||Cycle 3 Day 1: Appetite Loss||10.11|-17.46|
71104566|NCT02989857|141716575|OTHER||Least-squares mean difference|-5.1|||||TWO_SIDED|95.0|-12.93|2.8||||||Cycle 2 Day 1: Pain||2.80|-12.93|
70850624|NCT02712047|141189438|OTHER||Mean Difference (Net)|-6.88|||||TWO_SIDED|95.0|-29.96|16.19|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 13, PM|||16.19|-29.96|
70929992|NCT02938923|141357389|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.699|TWO_SIDED|95.0|-3.64|2.45||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -0.39|Differences between the changes (EX+T - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure.||2.45|-3.64|0.699
71015157|NCT03309072|141537622|OTHER|To compare the old and new faces' hit rate, we calculated the true positive rate (TPR: the proportion of positives that are correctly identified as such). A repeated measures ANOVA was conducted with the TPR for both old and new faces as within-subjects variable and group (active vs sham) as between-subjects variable.|Mean Difference (Net)|10.66|||<|0.049|TWO_SIDED||||||ANOVA||Difference between active tDCS and sham tDCS|||||<.049
71049446|NCT02504671|141606189|OTHER||Difference|18.9|||||TWO_SIDED|95.0|1.1|36.7|||||Week 24, ACR50. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||36.7|1.1|
71049447|NCT02504671|141606189|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Week 24, ACR70. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||10.3|-10.3|
71049448|NCT02504671|141606189|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-5.1|21.3|||||Week 24, ACR70. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||21.3|-5.1|
71049449|NCT02504671|141606189|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-5.1|21.3|||||Week 24, ACR70. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||21.3|-5.1|
71049450|NCT02504671|141606189|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 28, ACR20. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71049451|NCT02504671|141606189|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 28, ACR20. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71049452|NCT02504671|141606189|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 28, ACR20. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71049453|NCT02504671|141606189|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 28, ACR50. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71049454|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 28, ACR50. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049455|NCT02504671|141606189|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 28, ACR50. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71049456|NCT02504671|141606189|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 28, ACR70. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71049457|NCT02504671|141606189|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 28, ACR70. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71049458|NCT02504671|141606189|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 28, ACR70. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71049459|NCT02504671|141606189|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 32, ACR20. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71049460|NCT02504671|141606189|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Week 32, ACR20. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
71049461|NCT02504671|141606189|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Week 32, ACR20. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
71049462|NCT02504671|141606189|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 32, ACR50. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71049463|NCT02504671|141606189|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Week 32, ACR50. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
71049464|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 32, ACR50. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049465|NCT02504671|141606189|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 32, ACR70. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
71104567|NCT02989857|141716575|OTHER||Least-squares mean difference|0.7|||||TWO_SIDED|95.0|-6.56|7.88||||||Cycle 2 Day 1: Appetite Loss||7.88|-6.56|
71104568|NCT02989857|141716575|OTHER||Least-squares mean difference|4.4|||||TWO_SIDED|95.0|-5.82|14.55||||||Cycle 3 Day 1: Pain||14.55|-5.82|
71104569|NCT02989857|141716575|OTHER||Least-squares mean difference|-6.1|||||TWO_SIDED|95.0|-15.34|3.12||||||Cycle 3 Day 1: Appetite Loss||3.12|-15.34|
71104570|NCT01168596|141716601|SUPERIORITY_OR_OTHER||Slope|1.3|STANDARD_ERROR_OF_MEAN|5.26||0.81|TWO_SIDED|95.0|-9.13|11.73|||Regression, Linear|||||11.73|-9.13|0.81
70929993|NCT02938923|141357389|SUPERIORITY||Mean Difference (Final Values)|-2.18||||0.163|TWO_SIDED|95.0|-5.24|0.89||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -1.4|Difference in the changes (EX+P - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure.||0.89|-5.24|0.163
71015158|NCT00124709|141537652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0046||||0.7901|TWO_SIDED|95.0|-0.029|0.0381|||ANCOVA|Treatment, Center, gender, baseline age (months), baseline EASI score, and baseline TBSA as explanatory variables||"A disease-free day in Step 2 or less was defined as a diary day with variable No or almost no eczema?=yes and medication used variable=no except emollients, yellow label medication 2X day, or medication deviation of yellow label medication 1x day."||0.0381|-0.0290|0.7901
71049466|NCT02504671|141606189|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 32, ACR70. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71049467|NCT02504671|141606189|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 32, ACR70. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71049468|NCT02504671|141606189|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 36, ACR20. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71049469|NCT02504671|141606189|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 36, ACR20. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71049470|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 36, ACR20. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049471|NCT02504671|141606189|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 36, ACR50. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
71049472|NCT02504671|141606189|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 36, ACR50. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71049473|NCT02504671|141606189|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 36, ACR50. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
71049474|NCT02504671|141606189|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 36, ACR70. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049475|NCT02504671|141606189|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 36, ACR70. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
71049476|NCT02504671|141606189|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 36, ACR70. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71049477|NCT02504671|141606189|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 40, ACR20. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71049478|NCT02504671|141606189|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 40, ACR20. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71049479|NCT02504671|141606189|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Week 40, ACR20. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
71049480|NCT02504671|141606189|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 40, ACR50. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71049481|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 40, ACR50. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049482|NCT02504671|141606189|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 40, ACR50. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71049483|NCT02504671|141606189|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 40, ACR70. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
71049484|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 40, ACR70. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049485|NCT02504671|141606189|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 40, ACR70. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71049486|NCT02504671|141606189|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 44, ACR20. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71049487|NCT02504671|141606189|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 44, ACR20. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71049488|NCT02504671|141606189|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 44, ACR20. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
70929994|NCT02938923|141357389|SUPERIORITY||Mean Difference (Final Values)|1.59||||0.137|TWO_SIDED|95.0|-0.51|3.69||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = 1.49|Difference between the changes (EX+T - EX+P)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure in the model with covariates.||3.69|-0.51|0.137
70929995|NCT02938923|141357389|SUPERIORITY||Mean Difference (Final Values)|-0.69||||0.648|TWO_SIDED|95.0|-3.68|2.29||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -0.46|Difference between the changes (EX+T - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure in the model with covariates.||2.29|-3.68|0.648
70929996|NCT02938923|141357389|SUPERIORITY||Mean Difference (Final Values)|-2.28||||0.135|TWO_SIDED|95.0|-5.29|0.72||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -1.50|Difference between the changes (EX+P - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure in the model with covariates.||0.72|-5.29|0.135
71104571|NCT01168596|141716602|SUPERIORITY_OR_OTHER||Slope|4.38|STANDARD_ERROR_OF_MEAN|3.6||0.23|TWO_SIDED|95.0|-2.75|11.51|||Regression, Linear|||||11.51|-2.75|0.23
71104572|NCT01168596|141716603|SUPERIORITY_OR_OTHER||Slope|1.61|STANDARD_ERROR_OF_MEAN|5.03||0.75|TWO_SIDED|95.0|-8.37|11.59|||Regression, Linear|||||11.59|-8.37|0.75
71104573|NCT01168596|141716604|SUPERIORITY_OR_OTHER||Slope|1.88|STANDARD_ERROR_OF_MEAN|3.06||0.54|TWO_SIDED|95.0|-4.18|7.94|||Regression, Linear|||||7.94|-4.18|0.54
71104574|NCT01168596|141716605|SUPERIORITY_OR_OTHER||Slope|-5.17|STANDARD_ERROR_OF_MEAN|6.36||0.42|TWO_SIDED|95.0|-17.76|7.43|||Regression, Linear|||||7.43|-17.76|0.42
71104575|NCT01168596|141716606|SUPERIORITY_OR_OTHER||Slope|0.36|STANDARD_ERROR_OF_MEAN|0.47||0.44|TWO_SIDED|95.0|-0.56|1.29|||Regression, Linear|||||1.29|-0.56|0.44
71104576|NCT01168596|141716607|SUPERIORITY_OR_OTHER||Slope|2.27|STANDARD_ERROR_OF_MEAN|10.02||0.82|TWO_SIDED|95.0|-17.59|22.13|||Regression, Linear|||||22.13|-17.59|0.82
71104577|NCT01168596|141716608|SUPERIORITY_OR_OTHER||Slope|-4.73|STANDARD_ERROR_OF_MEAN|7.36||0.52|TWO_SIDED|95.0|-19.31|9.85|||Regression, Linear|||||9.85|-19.31|0.52
71104578|NCT01168596|141716609|SUPERIORITY_OR_OTHER||Slope|0.11|STANDARD_ERROR_OF_MEAN|1.14||0.93|TWO_SIDED|95.0|-2.15|2.36|||Regression, Linear|||||2.36|-2.15|0.93
71104579|NCT01168596|141716610|SUPERIORITY_OR_OTHER||Slope|-0.11|STANDARD_ERROR_OF_MEAN|0.47||0.82|TWO_SIDED|95.0|-1.05|0.83|||Regression, Linear|||||0.83|-1.05|0.82
71104580|NCT01168596|141716611|SUPERIORITY_OR_OTHER||Slope|-4.53|STANDARD_ERROR_OF_MEAN|7.68||0.56|TWO_SIDED|95.0|-19.74|10.69|||Regression, Linear|||||10.69|-19.74|0.56
71104581|NCT01168596|141716612|SUPERIORITY_OR_OTHER||Slope|-2.21|STANDARD_ERROR_OF_MEAN|2.93||0.45|TWO_SIDED|95.0|-8.02|3.59|||Regression, Linear|||||3.59|-8.02|0.45
71104582|NCT01168596|141716613|SUPERIORITY_OR_OTHER||Slope|2.76|STANDARD_ERROR_OF_MEAN|4.94||0.58|TWO_SIDED|95.0|-7.02|12.55|||Regression, Linear|||||12.55|-7.02|0.58
71104583|NCT01168596|141716614|SUPERIORITY_OR_OTHER||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.54||0.95|TWO_SIDED|95.0|-1.04|1.11|||Regression, Linear|||||1.11|-1.04|0.95
70929997|NCT02938923|141357390|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.821|TWO_SIDED|95.0|-0.073|0.058||Unadjusted p-value|Mixed Models Analysis|t (df, 92) = -0.23|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive AR(1) covariance structure.||0.058|-0.073|0.821
70929998|NCT02938923|141357390|SUPERIORITY||Mean Difference (Final Values)|0.013||||0.789|TWO_SIDED|95.0|-0.082|0.108||Unadjusted p-value|Mixed Models Analysis|t (df, 92) = 0.27|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive AR(1) covariance structure.||0.108|-0.082|0.789
71104584|NCT01168596|141716615|SUPERIORITY_OR_OTHER||Slope|-0.38|STANDARD_ERROR_OF_MEAN|0.54||0.48|TWO_SIDED|95.0|-1.45|0.69|||Regression, Linear|||||0.69|-1.45|0.48
71104585|NCT01168596|141716616|SUPERIORITY_OR_OTHER||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.33||0.84|TWO_SIDED|95.0|-0.71|0.58|||Regression, Linear|||||0.58|-0.71|0.84
71104586|NCT01168596|141716617|SUPERIORITY_OR_OTHER||Slope|0.49|STANDARD_ERROR_OF_MEAN|0.64||0.44|TWO_SIDED|95.0|-0.77|1.76|||Regression, Linear|||||1.76|-0.77|0.44
71104587|NCT01168596|141716618|SUPERIORITY_OR_OTHER||Slope|-0.33|STANDARD_ERROR_OF_MEAN|0.88||0.71|TWO_SIDED|95.0|-2.06|1.41|||Regression, Linear|||||1.41|-2.06|0.71
71104588|NCT01168596|141716619|SUPERIORITY_OR_OTHER||Slope|0.64|STANDARD_ERROR_OF_MEAN|0.64||0.31|TWO_SIDED|95.0|-0.62|1.9|||Regression, Linear|||||1.90|-0.62|0.31
71104589|NCT01168596|141716620|SUPERIORITY_OR_OTHER||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.82||0.94|TWO_SIDED|95.0|-1.68|1.56|||Regression, Linear|||||1.56|-1.68|0.94
71104590|NCT00123630|141716645|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
71104591|NCT01098747|141716665|SUPERIORITY_OR_OTHER||Least-square (LS) mean difference|24.21|||<|0.001|TWO_SIDED|95.0|19.32|29.09||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms.|ANOVA|||Treatment difference (Ibuprofen sodium - placebo) and 95 percent (%) confidence interval (CI):based on LS means from analysis of variance(ANOVA). Type I error controlled at 5% significance level (2-sided) by testing primary endpoints sequentially: Ibuprofen sodium (IBU Na) versus(vs.) Placebo for SPRID 0-8 then time to meaningful relief(TMR), IBU Na vs. IBU (Advil and Motrin IB) for TMR. If comparison at preceding step was significant only then subsequent comparisons were significant.||29.09|19.32|<0.001
71104592|NCT01098747|141716666|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|12.8|||<|0.001|TWO_SIDED|95.0|6.78|24.15||p-value was calculated using the PH model with treatment, baseline PSR and gender terms.|Proportional hazards model|||Hazard Ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model. Type I error controlled at 5% significance level (2-sided) by testing primary endpoints sequentially: IBU Na vs. Placebo for SPRID 0-8 then TMR, IBU Na vs. IBU (Advil and Motrin IB) for TMR. If comparison at preceding step was significant only then subsequent comparisons were significant.||24.15|6.78|<0.001
71015159|NCT01728376|141537664|SUPERIORITY_OR_OTHER||Difference (%)|-2.5|||||TWO_SIDED|95.0|-30.3|25.3|||||Daptomycin minus Comparator 95% Confidence Interval (CI) by Wilson score method|Difference in satisfactory response between treatment groups. Satisfactory response = cured + improved||25.3|-30.3|
71117598|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
70850625|NCT02712047|141189438|OTHER||Mean Difference (Net)|28.45|||||TWO_SIDED|95.0|5.76|51.13|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 14, AM|||51.13|5.76|
71015160|NCT01728376|141537664|SUPERIORITY_OR_OTHER||Difference (%)|16.3|||||TWO_SIDED|95.0|-13.0|45.7|||||Daptomycin minus Comparator 95% CI by Wilson score method|Difference in satisfactory response between treatment groups. Satisfactory response = cured + improved||45.7|-13.0|
71015161|NCT01728376|141537664|SUPERIORITY_OR_OTHER||Difference (%)|25.7|||||TWO_SIDED|95.0|-21.0|72.4|||||Daptomycin minus Comparator 95% CI by Wilson score method|Difference in satisfactory response between treatment groups. Satisfactory response = cured + improved||72.4|-21.0|
71015162|NCT01728376|141537665|SUPERIORITY_OR_OTHER||Difference (%)|5.0|||||TWO_SIDED|95.0|-29.8|39.8|||||Daptomycin minus Comparator 95% CI by Wilson score method|Difference in success response between treatment arms||39.8|-29.8|
71015163|NCT01728376|141537665|SUPERIORITY_OR_OTHER||Difference (%)|37.9|||||TWO_SIDED|95.0|0.7|75.1|||||Daptomycin minus Comparator 95% CI by Wilson score method|Difference in success response between treatment arms||75.1|0.7|
71015164|NCT01728376|141537665|SUPERIORITY_OR_OTHER||Difference (%)|-10.0||||||95.0|-60.3|40.3|||||Daptomycin minus Comparator 95% CI by Wilson score method|Difference in success response between treatment arms||40.3|-60.3|
71015165|NCT03491800|141537675|SUPERIORITY||Mean Difference (Net)|7.5|STANDARD_ERROR_OF_MEAN|0.15||0.3|TWO_SIDED||||||t-test, 2 sided|||||||0.30
71015166|NCT03491800|141537676|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.43||0.9|TWO_SIDED||||||t-test, 2 sided|||||||0.90
71015167|NCT03491800|141537676|SUPERIORITY||Mean Difference (Final Values)|4.44|STANDARD_ERROR_OF_MEAN|0.26||0.3|TWO_SIDED||||||t-test, 2 sided|||||||0.30
71015168|NCT03491800|141537677|SUPERIORITY||Mean Difference (Final Values)|-3.03|STANDARD_ERROR_OF_MEAN|-0.28||0.4|TWO_SIDED||||||t-test, 2 sided|||||||0.40
71015169|NCT03491800|141537677|SUPERIORITY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.22||0.85|TWO_SIDED||||||t-test, 2 sided|||||||0.85
71015170|NCT03491800|141537678|SUPERIORITY||Mean Difference (Final Values)|-5.05|STANDARD_ERROR_OF_MEAN|-0.25||0.21|TWO_SIDED||||||t-test, 2 sided|||||||0.21
71015171|NCT03491800|141537679|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.23||0.95|TWO_SIDED||||||t-test, 2 sided|||||||0.95
71015172|NCT03491800|141537680|SUPERIORITY||Mean Difference (Final Values)|3.34|STANDARD_ERROR_OF_MEAN|-0.2||0.52|TWO_SIDED||||||t-test, 2 sided|||||||0.52
71015173|NCT03491800|141537681|SUPERIORITY||Mean Difference (Final Values)|-38.25|STANDARD_ERROR_OF_MEAN|-38.25||0.23|TWO_SIDED||||||t-test, 2 sided|||||||0.23
71015174|NCT03491800|141537681|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|22.0||0.67|TWO_SIDED||||||t-test, 2 sided|||||||0.67
71015175|NCT03491800|141537681|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|9.62||0.054|TWO_SIDED||||||t-test, 2 sided|||||||0.054
71015176|NCT03491800|141537682|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|5.4||0.6|TWO_SIDED||||||t-test, 2 sided|||||||0.60
71015177|NCT03491800|141537682|SUPERIORITY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|3.29||0.4|TWO_SIDED||||||t-test, 2 sided|||||||0.40
71015178|NCT01256086|141537687|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Relative potency of Novolizer compared to Aerolizer. Equivalence was to be concluded if the CI for the relative potency was completely covered by the interval (0.67, 1.50) according to OIP Guideline.|Relative potency|1.13|||||TWO_SIDED|90.0|0.94|1.38|||||Fieller confidence interval for logarithm of relative potency|||1.38|0.94|
71015179|NCT05604521|141537690|SUPERIORITY|||||||0.3944|||||||Fisher Exact|||Null hypothesis: There is no statistically significant difference between the vaccine and control groups in the proportion of participants experiencing any local solicited AEs after any vaccination.||||0.3944
71015180|NCT05604521|141537690|SUPERIORITY|||||||0.3717|||||||Fisher Exact|||Null hypothesis: There is no statistically significant difference between the vaccine and control groups in the proportion of participants experiencing any systemic solicited AEs after any vaccination.||||0.3717
71015181|NCT05604521|141537690|SUPERIORITY|||||||1|||||||Fisher Exact|||Null hypothesis: There is no statistically significant difference between the vaccine and control groups in the proportion of participants experiencing any related unsolicited AEs after any vaccination.||||1.0
71015182|NCT01491737|141537691|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.007|TWO_SIDED|95.0|0.48|0.89||Test was performed at 2-sided alpha of 5%.|Log Rank|Stratified log-rank test based upon Kaplan-Meier including induction chemotherapy and prior adjuvant hormone therapy stratification factors.|Hazard ratio comparing Arm A vs. B from stratified Cox proportional hazards model including stratification factors.|Primary Analysis. Log Rank tested the following: Null Hypothesis (H0): the distribution of the PFS time was the same in Arms A \& B; The Alternative Hypothesis (H1): the distribution of the PFS time was different in Arms A \& B. A Cox proportional hazards model tested the HR. If the HR of investigational arm (Arm A) compared with control arm (Arm B) with respect to PFS was assumed to be constant over time (λ) then the null (H0) and alternative hypotheses (H1) were: H0: λ =1; H1: λ ≠1.||0.89|0.48|0.0070
71015183|NCT01491737|141537691|OTHER|Exploratory|Hazard Ratio (HR)|0.67||||0.0059|TWO_SIDED|95.0|0.5|0.89|||Log Rank|Stratified log-rank test based upon Kaplan-Meier including induction chemotherapy and prior adjuvant hormone therapy stratification factors.|Hazard ratio comparing Arm A vs. B from stratified Cox proportional hazards model including stratification factors.|Final Analysis||0.89|0.50|0.0059
71015184|NCT01491737|141537692|OTHER|Exploratory|Hazard Ratio (HR)|1.15||||0.585|TWO_SIDED|95.0|0.69|1.91|||Log Rank|Stratified log-rank test based upon Kaplan-Meier including induction chemotherapy and prior adjuvant hormone therapy stratification factors.|Hazard ratio comparing Arm A vs. B from stratified Cox proportional hazards model including stratification factors.|Primary Analysis. This study was not powered for overall survival (OS), so adequately powered statistical testing for this outcome measure was not possible.||1.91|0.69|0.5850
71015185|NCT01491737|141537692|OTHER|Exploratory|Hazard Ratio (HR)|1.05||||0.7833|TWO_SIDED|95.0|0.73|1.52|||Log Rank|Stratified log-rank test based upon Kaplan-Meier including induction chemotherapy and prior adjuvant hormone therapy stratification factors.|Hazard ratio comparing Arm A vs. B from stratified Cox proportional hazards model including stratification factors.|Final Analysis. This study was not powered for overall survival (OS), so adequately powered statistical testing for this outcome measure was not possible.||1.52|0.73|0.7833
71015186|NCT01491737|141537693|SUPERIORITY||Difference in ORR|7.6||||0.2537|TWO_SIDED|95.0|-6.0|21.3||Test was performed at 2-sided alpha of 5%. There was no multiplicity adjustment.|Chi-squared|||ORR for Arm A vs Arm B||21.3|-6.0|0.2537
71015187|NCT01491737|141537694|SUPERIORITY||Difference in CBR|1.8||||0.7743|TWO_SIDED|95.0|-11.2|14.8||Test was performed at 2-sided alpha of 5%. There was no multiplicity adjustment.|Chi-squared|||CBR for Arm A vs. Arm B||14.8|-11.2|0.7743
71015188|NCT01491737|141537695|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.0181|TWO_SIDED|95.0|0.36|0.91||Test was performed at 2-sided alpha of 5%.|Log Rank|Log-rank test from unstratified analysis based upon Kaplan-Meier approach. There was no multiplicity adjustment.|Hazard ratio from stratified Cox proportional hazards model including stratification factors of induction chemotherapy and prior adjuvant hormone therapy.|Primary Analysis. Log Rank tested the following: Null Hypothesis (H0): the distribution of the DOR time was the same in Arms A \& B; The Alternative Hypothesis (H1): the distribution of the DOR time was different in Arms A \& B. A Cox proportional hazards model tested the HR. If the HR of investigational arm (Arm A) compared with control arm (Arm B) with respect to DOR was assumed to be constant over time (λ) then the null (H0) and alternative hypotheses (H1) were: H0: λ =1; H1: λ ≠1.||0.91|0.36|0.0181
71049489|NCT02504671|141606189|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 44, ACR50. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71049490|NCT02504671|141606189|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 44, ACR50. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71049491|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 44, ACR50. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049492|NCT02504671|141606189|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 44, ACR70. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049493|NCT02504671|141606189|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 44, ACR70. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
71049494|NCT02504671|141606189|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 44, ACR70. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71049495|NCT02504671|141606189|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 48, ACR20. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71049496|NCT02504671|141606189|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 48, ACR20. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71049497|NCT02504671|141606189|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 48, ACR20. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71049498|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 48, ACR50. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049499|NCT02504671|141606189|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 48, ACR50. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71049500|NCT02504671|141606189|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 48, ACR50. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71049501|NCT02504671|141606189|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 48, ACR70. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
70850626|NCT02712047|141189438|OTHER||Mean Difference (Net)|12.31|||||TWO_SIDED|95.0|-10.13|34.74|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 14, PM|||34.74|-10.13|
71049502|NCT02504671|141606189|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 48, ACR70. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
71049503|NCT02504671|141606189|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Week 48, ACR70. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71049504|NCT02504671|141606189|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 52, ACR20. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71049505|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 52, ACR20. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049506|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 52, ACR20. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049507|NCT02504671|141606189|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 52, ACR50. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71049508|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 52, ACR50. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71015189|NCT01491737|141537695|OTHER|Exploratory|Hazard Ratio (HR)|0.62||||0.0205|TWO_SIDED|95.0|0.41|0.93|||Log Rank|Log-rank test from unstratified analysis based upon Kaplan-Meier approach. There was no multiplicity adjustment.|Hazard ratio from stratified Cox proportional hazards model including stratification factors of induction chemotherapy and prior adjuvant hormone therapy.|Final Analysis.||0.93|0.41|0.0205
71015190|NCT01491737|141537696|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.5597|TWO_SIDED|95.0|0.78|1.57||Test was performed at 2-sided alpha of 5%.|Log Rank|The log-rank test from unstratified analysis was based upon Kaplan-Meier approach. There was no multiplicity adjustment.|Hazard ratio from stratified Cox proportional hazards model including the induction chemotherapy and prior adjuvant hormone therapy stratification factors.|Log Rank tested the following: Null Hypothesis (H0): the distribution of the TTR time was the same in Arms A \& B; The Alternative Hypothesis (H1): the distribution of the TTR time was different in Arms A \& B. A Cox proportional hazards model tested the HR. If the HR of investigational arm (Arm A) compared with control arm (Arm B) with respect to TTR was assumed to be constant over time (λ) then the null (H0) and alternative hypotheses (H1) were: H0: λ =1; H1: λ ≠1.||1.57|0.78|0.5597
71015191|NCT04311411|141537701|SUPERIORITY||Median Difference (Final Values)|-534.11|||<|0.0001|TWO_SIDED|95.0|-668.2|-400.02|||ANCOVA|||||-400.02|-668.20|<.0001
71015192|NCT04311411|141537702|SUPERIORITY||Median Difference (Final Values)|0.0439||||0.5437|TWO_SIDED|95.0|-0.0994|0.1871|||Mixed Models Analysis|||Insula||0.1871|-0.0994|0.5437
71015193|NCT04311411|141537702|SUPERIORITY||Mean Difference (Final Values)|0.093||||0.1806|TWO_SIDED|95.0|-0.0441|0.2301|||Mixed Models Analysis|||Insula||0.2301|-0.0441|0.1806
71015194|NCT04311411|141537702|SUPERIORITY||Mean Difference (Final Values)|-0.0491||||0.472|TWO_SIDED|95.0|-0.1846|0.0863|||Mixed Models Analysis|||Insula||0.0863|-0.1846|0.4720
71015195|NCT04311411|141537702|SUPERIORITY||Mean Difference (Final Values)|-0.0011||||0.9842|TWO_SIDED|95.0|-0.1079|0.1058|||Mixed Models Analysis|||Medial frontal gyrus||0.1058|-0.1079|0.9842
71015196|NCT04311411|141537702|SUPERIORITY||Mean Difference (Final Values)|0.0077||||0.8822|TWO_SIDED|95.0|-0.0949|0.1102|||Mixed Models Analysis|||Medial frontal gyrus||0.1102|-0.0949|0.8822
71015197|NCT04311411|141537702|SUPERIORITY||Mean Difference (Final Values)|-0.0087||||0.8657|TWO_SIDED|95.0|-0.1111|0.0937|||Mixed Models Analysis|||Medial frontal gyrus||0.0937|-0.1111|0.8657
71015198|NCT04311411|141537702|SUPERIORITY||Mean Difference (Final Values)|0.0043||||0.9599|TWO_SIDED|95.0|-0.165|0.1736|||Mixed Models Analysis|||Superior temporal gyrus||0.1736|-0.1650|0.9599
71015199|NCT04311411|141537702|SUPERIORITY||Mean Difference (Final Values)|0.0489||||0.549|TWO_SIDED|95.0|-0.1129|0.2107|||Mixed Models Analysis|||Superior temporal gyrus||0.2107|-0.1129|0.5490
71049509|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 52, ACR50. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71015200|NCT04311411|141537702|SUPERIORITY||Mean Difference (Final Values)|-0.0446||||0.5854|TWO_SIDED|95.0|-0.2068|0.1176|||Mixed Models Analysis|||Superior temporal gyrus||0.1176|-0.2068|0.5854
71015201|NCT04311411|141537702|SUPERIORITY||Mean Difference (Final Values)|-0.0192||||0.7203|TWO_SIDED|95.0|-0.1259|0.0874|||Mixed Models Analysis|||Precentral gyrus||0.0874|-0.1259|0.7203
71015202|NCT04311411|141537702|SUPERIORITY||Mean Difference (Final Values)|0.0404||||0.433|TWO_SIDED|95.0|-0.0617|0.1425|||Mixed Models Analysis|||Precentral gyrus||0.1425|-0.0617|0.4330
71015203|NCT04311411|141537702|SUPERIORITY||Mean Difference (Final Values)|-0.0596||||0.2488|TWO_SIDED|95.0|-0.1619|0.0426|||Mixed Models Analysis|||Precentral gyrus||0.0426|-0.1619|0.2488
71015204|NCT04311411|141537702|SUPERIORITY||Mean Difference (Final Values)|-0.007||||0.8886|TWO_SIDED|95.0|-0.1059|0.0919|||Mixed Models Analysis|||Cingulate gyrus||0.0919|-0.1059|0.8886
71015205|NCT04311411|141537702|SUPERIORITY||Mean Difference (Final Values)|0.0684||||0.1563|TWO_SIDED|95.0|-0.0267|0.1635|||Mixed Models Analysis|||Cingulate gyrus||0.1635|-0.0267|0.1563
71015206|NCT04311411|141537702|SUPERIORITY||Mean Difference (Final Values)|-0.0754||||0.1182|TWO_SIDED|95.0|-0.1704|0.0196|||Mixed Models Analysis|||Cingulate gyrus||0.0196|-0.1704|0.1182
71015207|NCT04311411|141537703|SUPERIORITY||Mean Difference (Final Values)|20.57|||<|0.0001|TWO_SIDED|95.0|12.11|29.02|||Mixed Models Analysis|||Fasting (Pre-lunch)||29.02|12.11|<.0001
71015208|NCT04311411|141537703|SUPERIORITY||Mean Difference (Final Values)|6.63||||0.1097|TWO_SIDED|95.0|-1.53|14.79||Fasting|Mixed Models Analysis|||Fasting (Pre-lunch)||14.79|-1.53|0.1097
71015209|NCT04311411|141537703|SUPERIORITY||Mean Difference (Final Values)|13.94||||0.0015|TWO_SIDED|95.0|5.49|22.38|||Mixed Models Analysis|||Fasting (Pre-lunch)||22.38|5.49|0.0015
71015210|NCT04311411|141537703|SUPERIORITY||Mean Difference (Final Values)|2.25||||0.4469|TWO_SIDED|95.0|-3.6|8.09|||Mixed Models Analysis|||Postprandial (Post-lunch)||8.09|-3.60|0.4469
71015211|NCT04311411|141537703|SUPERIORITY||Mean Difference (Final Values)|0.64||||0.8227|TWO_SIDED|95.0|-5.02|6.31|||Mixed Models Analysis|||Postprandial (Post-lunch)||6.31|-5.02|0.8227
71015212|NCT04311411|141537703|SUPERIORITY||Mean Difference (Final Values)|1.61||||0.5861|TWO_SIDED|95.0|-4.23|7.45|||Mixed Models Analysis|||Postprandial (Post-lunch)||7.45|-4.23|0.5861
71015213|NCT01817764|141537708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.074|||<|0.001|TWO_SIDED|95.0|0.038|0.11|||ANCOVA|||||0.110|0.038|<0.001
71049510|NCT02504671|141606189|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 52, ACR70. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049511|NCT02504671|141606189|OTHER||Difference|16.2|||||TWO_SIDED|95.0|4.3|28.1|||||Week 52, ACR70. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|4.3|
71049512|NCT02504671|141606189|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 52, ACR70. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71104593|NCT01098747|141716666|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.59|||<|0.001|TWO_SIDED|95.0|1.22|2.06||p-value was calculated using the PH model with treatment, baseline PSR and gender terms.|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model. Type I error controlled at 5% significance level (2-sided) by testing primary endpoints sequentially: IBU Na vs. Placebo for SPRID 0-8 then TMR, IBU Na vs. IBU (Advil and Motrin IB) for TMR. If comparison at preceding step was significant only then subsequent comparisons were significant.||2.06|1.22|<0.001
70929999|NCT02938923|141357390|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.672|TWO_SIDED|95.0|-0.075|0.116||Unadjusted p-value|Mixed Models Analysis|t (df, 92) = 0.42|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive AR(1) covariance structure.||0.116|-0.075|0.672
71015214|NCT04888377|141537710|NON_INFERIORITY|The primary hypothesis of non-inferiority was tested by calculating the mean difference between treatment arms and its associated 90% confidence interval for the primary outcome. If the lower bound of the 90% confidence interval was greater than -4, then LDA was assumed to be non-inferior to placebo. If non-inferiority were assumed, a one-sided t-test would test the benefit of LDA compared to placebo. All models controlled for site as the original randomization stratification factor.|Mean Difference (Final Values)|-0.8||||0.25|TWO_SIDED|95.0|-2.2|0.6||For each outcome, the adjusted mean difference between treatment groups and the associated 95% confidence interval based on an ANCOVA model is presented.|ANCOVA||Mean difference is Aspirin-Placebo.|Assuming a non-inferiority margin of 4 points in the BSID-III cognitive score as clinically significant, and a true effect of LDA of not more than a 1 point decrease, a total sample size of 620 was determined to provide 80% power for a one-sided test for non-inferiority with a type I error of 5%. To test this secondary hypothesis, the sample size also provided over 90% power, at a two-sided type I error of 5%, to detect a difference of 4 points between LDA and placebo based on a two-sided test.||0.6|-2.2|0.25
71104594|NCT01098747|141716667|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|12.36|||<|0.001|TWO_SIDED|95.0|6.51|23.46||p-value was calculated using the PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||23.46|6.51|<0.001
71015215|NCT05644756|141537729|OTHER|The primary analysis examined changes in measurement-based care (MBC) collection over time using ANOVA. The study was not designed as a superiority, non-inferiority, or equivalence trial.|||||>|0.01|||||||ANOVA|||||||>.01
71015216|NCT00617175|141537743|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Negative binomial regression|||||||<0.001
71015217|NCT03586427|141537745|OTHER|Mixed model of repeated measures least square estimates of change compared to placebo|||||>|0.05||||||Comparison of each dose level change from baseline to placebo baseline yielded P values \>0.05|Mixed Models Analysis|||Each dose group was compared to placebo||||>0.05
71015218|NCT00423137|141537756|OTHER||Difference of least square means|-1.385|STANDARD_ERROR_OF_MEAN|2.181||0.5305|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.||||||0.5305
71015219|NCT00423137|141537757|OTHER||Difference of least square means|-0.049|STANDARD_ERROR_OF_MEAN|0.033||0.1498|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.1498
71015220|NCT00423137|141537760|OTHER||Difference of least square means|0.335|STANDARD_ERROR_OF_MEAN|0.434||0.4472|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.4472
71015221|NCT00423137|141537761|OTHER||Difference of least square means|-0.141|STANDARD_ERROR_OF_MEAN|0.342||0.6829|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.6829
71015222|NCT00423137|141537762|OTHER||Difference of least square means|0.571|STANDARD_ERROR_OF_MEAN|0.391||0.1565|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.1565
71015223|NCT00423137|141537763|OTHER||Difference of least square means|1.081|STANDARD_ERROR_OF_MEAN|1.185||0.3709|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.3709
71104595|NCT01098747|141716667|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.8|||<|0.001|TWO_SIDED|95.0|1.38|2.34||p-value was calculated using the PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||2.34|1.38|<0.001
70850627|NCT02712047|141189438|OTHER||Mean Difference (Net)|4.1|||||TWO_SIDED|95.0|-18.16|26.36|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 15, AM|||26.36|-18.16|
71015224|NCT00423137|141537764|OTHER||Difference of least square means|-52.083|STANDARD_ERROR_OF_MEAN|16.48||0.0044|||||||ANCOVA|The adjusted least squares mean is estimated based on the one way ANOVA model with Treatment.|Difference to Placebo \[Treatment-Placebo\]|||||0.0044
71015225|NCT00423137|141537765|OTHER||Difference of least square means|-67.012|STANDARD_ERROR_OF_MEAN|21.29||0.0056|||||||ANCOVA|The adjusted least squares mean is estimated based on the one way ANOVA model with Treatment.|Difference to Placebo \[Treatment-Placebo\]|||||0.0056
71015226|NCT00423137|141537766|OTHER||Difference of least square means|-62.571|STANDARD_ERROR_OF_MEAN|18.42||0.0025|||||||ANCOVA|The adjusted least squares mean is estimated based on the one way ANOVA model with Treatment.|Difference to Placebo \[Treatment-Placebo\]|||||0.0025
71015227|NCT00423137|141537767|OTHER||Difference of least square means|-40.067|STANDARD_ERROR_OF_MEAN|18.8||0.0439|||||||ANCOVA|The adjusted least squares mean is estimated based on the one way ANOVA model with Treatment.|Difference to Placebo \[Treatment-Placebo\]|||||0.0439
71015228|NCT00423137|141537768|OTHER||Difference of least square means|-57.46|STANDARD_ERROR_OF_MEAN|21.3||0.0129|||||||ANCOVA|The adjusted least squares mean is estimated based on the one way ANOVA model with Treatment.|Difference to Placebo \[Treatment-Placebo\]|||||0.0129
71015229|NCT00423137|141537769|OTHER||Difference of least square means|-55.332|STANDARD_ERROR_OF_MEAN|17.11||0.0037|||||||ANCOVA|The adjusted least squares mean is estimated based on the one way ANOVA model with Treatment.|Difference to Placebo \[Treatment-Placebo\]|||||0.0037
71104596|NCT01098747|141716668|SUPERIORITY_OR_OTHER||LS mean difference|0.35||||0.007|TWO_SIDED|95.0|0.1|0.6||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.60|0.10|0.007
71104597|NCT01098747|141716668|SUPERIORITY_OR_OTHER||LS mean difference|0.24||||0.01|TWO_SIDED|95.0|0.06|0.42||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.42|0.06|0.010
71104598|NCT01098747|141716668|SUPERIORITY_OR_OTHER||LS mean difference|1.47|||<|0.001|TWO_SIDED|95.0|1.1|1.84||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95 % CI were calculated based on LS mean from the ANOVA model.||1.84|1.10|<0.001
71104599|NCT01098747|141716668|SUPERIORITY_OR_OTHER||LS mean difference|0.53|||<|0.001|TWO_SIDED|95.0|0.27|0.8||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.80|0.27|<0.001
71104600|NCT01098747|141716668|SUPERIORITY_OR_OTHER||LS mean difference|2.22|||<|0.001|TWO_SIDED|95.0|1.84|2.6||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.60|1.84|<0.001
71104601|NCT01098747|141716668|SUPERIORITY_OR_OTHER||LS mean difference|0.39||||0.006|TWO_SIDED|95.0|0.12|0.66||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.66|0.12|0.006
71104602|NCT01098747|141716668|SUPERIORITY_OR_OTHER||LS mean difference|2.39|||<|0.001|TWO_SIDED|95.0|2.0|2.77||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.77|2.00|<0.001
70930000|NCT02938923|141357390|SUPERIORITY||Mean Difference (Final Values)|-0.002||||0.703|TWO_SIDED|95.0|-0.013|0.009||Unadjusted p-value|Mixed Models Analysis|t (df, 92) = -0.38||Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.|Difference between the changes (EX+T - EX+P)|0.009|-0.013|0.703
70930001|NCT02938923|141357390|SUPERIORITY||Mean Difference (Final Values)|-0.002||||0.803|TWO_SIDED|95.0|-0.017|0.014||Unadjusted p-value|Mixed Models Analysis|t (df, 92) = -0.25||Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.|Difference between the changes (EX+T - EUC)|0.014|-0.017|0.803
70930002|NCT02938923|141357390|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.991|TWO_SIDED|95.0|-0.015|0.016||Unadjusted p-value|Mixed Models Analysis|t (df, 92) = 0.01||Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.|Difference between the changes (EX+P - EUC)|0.016|-0.015|0.991
71104603|NCT01098747|141716668|SUPERIORITY_OR_OTHER||LS mean difference|0.33||||0.022|TWO_SIDED|95.0|0.05|0.6||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.60|0.05|0.022
71104604|NCT01098747|141716668|SUPERIORITY_OR_OTHER||LS mean difference|2.39|||<|0.001|TWO_SIDED|95.0|2.0|2.79||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.79|2.00|<0.001
71104605|NCT01098747|141716668|SUPERIORITY_OR_OTHER||LS mean difference|0.13||||0.369|TWO_SIDED|95.0|-0.15|0.41||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.41|-0.15|0.369
71104606|NCT01098747|141716668|SUPERIORITY_OR_OTHER||LS mean difference|2.19|||<|0.001|TWO_SIDED|95.0|1.78|2.6||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.60|1.78|<0.001
71104607|NCT01098747|141716668|SUPERIORITY_OR_OTHER||LS mean difference|-0.12||||0.42|TWO_SIDED|95.0|-0.42|0.17||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.17|-0.42|0.420
71104608|NCT01098747|141716668|SUPERIORITY_OR_OTHER||LS mean difference|2.02|||<|0.001|TWO_SIDED|95.0|1.58|2.45||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.45|1.58|<0.001
70930003|NCT04068792|141357423|OTHER||Mean Difference (Final Values)|-1.03|||||TWO_SIDED|90.0|-4.467|2.416||||||||2.416|-4.467|
70930004|NCT05513937|141357455|SUPERIORITY||Mean difference pre vs post|-15.2|STANDARD_DEVIATION|8.32|<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||||||<0.001
70930005|NCT02846545|141357457|SUPERIORITY||Least Square (LS) Mean|-0.178|||=|0.0004|TWO_SIDED|95.0|-0.28|-0.08|||Mixed Models Analysis|||||-0.08|-0.28|= 0.0004
71049513|NCT02504671|141606189|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 62 (follow-up), ACR20. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71049514|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 62 (follow-up), ACR20. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049515|NCT02504671|141606189|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 62 (follow-up), ACR20. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
71049516|NCT02504671|141606189|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 62 (follow-up), ACR50. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
71049517|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 62 (follow-up), ACR50. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049518|NCT02504671|141606189|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 62 (follow-up), ACR50. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71049519|NCT02504671|141606189|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Week 62 (follow-up), ACR70. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
70930006|NCT02846545|141357458|SUPERIORITY||LS Mean|-0.09|||=|0.802|TWO_SIDED|95.0|-0.81|0.63|||Mixed Models Analysis|||||0.63|-0.81|= 0.8020
70930007|NCT02846545|141357459|SUPERIORITY||Ratio of hypoglycemia rates|0.9|||=|0.0036|TWO_SIDED|95.0|0.838|0.966|||Poisson regression model|||Hypoglycemia rate was analyzed by using a Poisson regression model with the number of hypoglycemia events through Week 52 as the response, treatment and gender as fixed factors, age and baseline HbA1c as covariates, and the duration of study participation through week 52 in logarithm as an offset variable.||0.966|0.838|= 0.0036
71049520|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 62 (follow-up), ACR70. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049521|NCT02504671|141606189|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Week 62 (follow-up), ACR70. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
71049522|NCT02504671|141606189|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 1, ACR20. Difference to Placebo is presented for Week 1. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049523|NCT02504671|141606189|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 1, ACR20. Difference to Placebo is presented for Week 1. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
71049524|NCT02504671|141606189|OTHER||Difference|29.7|||||TWO_SIDED|95.0|12.7|46.8|||||Week 2, ACR20. Difference to Placebo is presented for Week 2. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||46.8|12.7|
71049525|NCT02504671|141606189|OTHER||Difference|37.8|||||TWO_SIDED|95.0|20.3|55.4|||||Week 2, ACR20. Difference to Placebo is presented for Week 2. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||55.4|20.3|
71049526|NCT02504671|141606189|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 2, ACR50. Difference to Placebo is presented for Week 2. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049527|NCT02504671|141606189|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 2, ACR50. Difference to Placebo is presented for Week 2. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049528|NCT02504671|141606189|OTHER||Difference|37.8|||||TWO_SIDED|95.0|19.5|56.1|||||Week 4, ACR20. Difference to Placebo is presented for Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||56.1|19.5|
71049529|NCT02504671|141606189|OTHER||Difference|51.4|||||TWO_SIDED|95.0|19.5|56.1|||||Week 4, ACR20. Difference to Placebo is presented for Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||56.1|19.5|
71049530|NCT02504671|141606189|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-8.7|14.1|||||Week 4, ACR50. Difference to Placebo is presented for Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||14.1|-8.7|
71049531|NCT02504671|141606189|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-8.7|14.1|||||Week 4, ACR50. Difference to Placebo is presented for Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||14.1|-8.7|
71049532|NCT02504671|141606189|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 4, ACR70. Difference to Placebo is presented for Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049533|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-6.8|33.8|||||Week 6, ACR20. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.8|-6.8|
70930008|NCT06468982|141357468|SUPERIORITY|To evaluate whether intra-aortic balloon pump catheter support contributes to a more rapid decrease in troponin levels and faster myocardial recovery, daily troponin levels were analyzed using mixed ANOVA.||||||0.05||||||The p-value was adjusted for multiple comparisons, and the threshold value was set at 0.05.|ANOVA|The hypothesis that IABP causes a rapid increase in troponin levels was analyzed using ANOVA, and the p-value was reported.||After testing for normality, the baseline characteristics of the two groups will be analyzed using the Student's t-test or the Mann-Whitney U-test for continuous variables and the chi-square test or Fisher's exact test for categorical variables. Differences between the intra-aortic balloon pump group and the control group in terms of repeated measurements will be analyzed using mixed ANOVA.||||0.05
70930009|NCT06468982|141357469|OTHER||Hazard Ratio, log|0.55|||<|0.05|TWO_SIDED|95.0|0.38|0.78|||Wilcoxon (Mann-Whitney)|||The prognostic value of risk factors for in-hospital mortality was evaluated by multivariate logistic regression analysis||0.78|0.38|<0.05
70930010|NCT02492711|141357486|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0334|TWO_SIDED|95.0|0.593|0.979|||Log Rank|Stratified Log-Rank Test|Stratified Cox Proportional Model|||0.979|0.593|0.0334
70930011|NCT02492711|141357487|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.6204|TWO_SIDED|95.0|0.774|1.165|||Log Rank|Stratified Log-Rank Test|Stratified Cox Proportional Model|||1.165|0.774|0.6204
70930012|NCT02492711|141357489|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0014|TWO_SIDED|95.0|0.556|0.87|||Log Rank|Stratified Log-Rank Test|Stratified Cox Proportional Model|||0.870|0.556|0.0014
70930013|NCT05932407|141357492|SUPERIORITY||Hazard Ratio (HR)|0.5|||||TWO_SIDED|95.0|0.1|2.0||||||Crude hazard ratio of Vortioxetine Tablets to SSRIs for intracranial hemorrhage was reported. Crude hazard ratio of Vortioxetine Tablet Treatment group relative to the control group (SSRI Treatment group) was calculated by the rate of Vortioxetine Tablet Treatment group divided by the rate of SSRI Treatment group.||2.0|0.1|
70930014|NCT05932407|141357492|SUPERIORITY|Adjusted hazard ratio was adjusted from crude hazard ratio by covariance 1 (age and gender), and covariance 2 (antithrombotic drug administration, NSAID administration, and hypertension).|Hazard Ratio (HR)|0.5|||||TWO_SIDED|95.0|0.1|1.9||||||Adjusted hazard ratio of Vortioxetine Tablets to SSRIs for intracranial hemorrhage was reported. Adjusted hazard ratio of Vortioxetine Tablet Treatment group relative to the control group (SSRI Treatment group) was calculated by the rate of Vortioxetine Tablet Treatment group divided by the rate of SSRI Treatment group.||1.9|0.1|
70930015|NCT03995979|141357517|SUPERIORITY|||||||0.05||||||The P-value was calculated using a paired t test|Paired t-test|||A compositional analysis with species-level alpha diversity will be performed between the three conditions (Pre-Dietary Restriction, Dietary Restriction, and Post-Dietary Restriction,) with ANOVA testing. Furthermore, a differential abundance analysis will be performed to further identify and confirm prevalent organisms associated with the experimental dietary restriction.||||0.05
70930016|NCT04505410|141357518|OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
70930017|NCT01586910|141357521|NON_INFERIORITY|Non-inferiority margin was 0.07. Posterior threshold for non-inferiority was 0.971|Posterior Median of the Difference|-1.4|||||TWO_SIDED|||||The posterior probability of non-inferiority is \> 0.9999. The posterior probability is the probability of the event rate by updating the prior probability distribution with observed data using Bayes' Theorem.|Bayesian||95% Bayesian credible interval for the difference (TAVR-SAVR) was (-5.2%, 2.3%). The 95% credible interval is the 2.5th and 97.5th percentiles of the posterior distribution.|Primary Hypothesis: TAVR with the Medtronic TAVR is non-inferior to SAVR for all-cause mortality or disabling stroke rate during a fixed follow-up of 24 months.||||
70930018|NCT03154190|141357547|SUPERIORITY||Hazard Ratio (HR)|0.3|||||TWO_SIDED|95.0|0.2|0.47|||Regression, Cox|||||0.47|0.20|
70930019|NCT03154190|141357548|SUPERIORITY||Hazard Ratio (HR)|0.48|||||TWO_SIDED|95.0|0.3|0.75|||Regression, Cox|||||0.75|0.30|
70930020|NCT03154190|141357551|SUPERIORITY||Risk Ratio (RR)|0.45|||||TWO_SIDED|95.0|0.33|0.62||||||||0.62|0.33|
70930021|NCT03154190|141357553|SUPERIORITY||Risk Ratio (RR)|0.5|||||TWO_SIDED|95.0|0.36|0.7||||||||0.70|0.36|
70930022|NCT03154190|141357558|SUPERIORITY||Odds Ratio (OR)|4.46|||||TWO_SIDED|95.0|1.88|10.55||||||||10.55|1.88|
70930023|NCT05850052|141357615|SUPERIORITY||Odds Ratio (OR)|1.24||||0.26|TWO_SIDED|95.0|0.85|1.79|||proportional-odds cumulative logit model|||||1.79|0.85|0.26
70930024|NCT05850052|141357616|SUPERIORITY||incidence rate ratio|1.02||||0.86|TWO_SIDED|97.5|0.82|1.27|||proportional-odds cumulative logit model|||||1.27|0.82|0.86
70930025|NCT05850052|141357617|SUPERIORITY||Risk Ratio (RR)|3.1||||0.36|TWO_SIDED|95.0|0.32|30.0|||Fisher Exact|||||30|0.32|0.36
70930026|NCT04881461|141357815|SUPERIORITY||Mean Difference (Final Values)|1.88||||0.0036|TWO_SIDED|95.0|0.6|3.17||Adjusted P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The endpoint analysis was based on a 5% significance level. The trial was designed to have 86% power for the primary endpoint using the primary (trial product) estimand."||3.17|0.60|0.0036
70930027|NCT04881461|141357816|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.1111|TWO_SIDED|95.0|-0.04|0.39||Adjusted P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction.|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The endpoint analysis was based on a 5% significance level. The trial was designed to have 95% power for this key secondary endpoint using the primary (trial product) estimand."||0.39|-0.04|0.1111
70930028|NCT04881461|141357817|SUPERIORITY||Mean Difference (Final Values)|1.33||||0.0417|TWO_SIDED|95.0|-0.01|2.67||Observed P-value|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||2.67|-0.01|0.0417
70930029|NCT04881461|141357818|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.4984|TWO_SIDED|95.0|-0.15|0.3||Observed P-value|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass SLIT drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||0.30|-0.15|0.4984
71015230|NCT00423137|141537770|OTHER||Difference of least square means|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.9076|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.9076
71015231|NCT00423137|141537771|OTHER||Difference of least square means|-13453.0|STANDARD_ERROR_OF_MEAN|16118.0||0.4121|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.4121
71015232|NCT00423137|141537772|OTHER||Difference of least square means|-78.619|STANDARD_ERROR_OF_MEAN|298.91||0.7948|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.7948
71015233|NCT00423137|141537773|OTHER||Difference of least square means|0.195|STANDARD_ERROR_OF_MEAN|0.101||0.064|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.0640
71015234|NCT00423137|141537774|OTHER||Difference of least square means|0.007|STANDARD_ERROR_OF_MEAN|0.004||0.0587|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.0587
71015235|NCT03478982|141537775|SUPERIORITY||Difference in percentage|23.3|||=|0.0392|TWO_SIDED|95.0|1.8|44.8|||Chi-squared|||||44.8|1.8|=0.0392
71015236|NCT03478982|141537775|SUPERIORITY||Difference in percentage|23.3|||=|0.0392|TWO_SIDED|95.0|1.8|44.8|||Chi-squared|||||44.8|1.8|=0.0392
71015237|NCT00593385|141537779|OTHER||Meta-Analysis|9.67||||0.005|ONE_SIDED|95.0||16.57||An exact one sided upper 95% confidence interval of the primary endpoint rate was calculated based on primary analysis population.|Exact test of the binomial distribution||To estimate primary endpoint rate, a meta-analysis was performed on data from 3 previous studies. The meta-analytical rate derived was 9.67%|The composite event rate to determine the performance metric of 16.57% was based on a meta-analysis performed on data from 3 previous studies(9.67%). A 6.9% margin was deemed acceptable at the time of study design. Rejection of the null hypothesis requires that the iCAST Covered Stent primary endpoint rate was significantly below 16.57%. Other assumptions for the analysis included a power of 80% and one-sided alpha error of 5%.||16.57||0.005
71015238|NCT01797458|141537811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||||||Twenty-five teeth experienced at least one 'Minor' failure (reversible pulpitis, caries progression, and secondary caries): NRCT 9 (6.4%), CR 14 (10%), HT 2 (1.4%).|Kruskal-Wallis|||The null hypothesis was no difference at 2 yrs among any of the 3 arms for the primary outcome of success or minor failure.||||0.02
71015239|NCT00659945|141537823|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|||The primary endpoint was the incidence of emesis at any time within the first 48 hours after surgery. Power analysis showed that a sample size of 69 patients per group was necessary to detect a significant decrease in the incidence of emesis from 33% in the placebo group to 15% in the aprepitant group using a Chi-square test with an alpha value of 0.05 and power of 80%.||||<0.05
71104609|NCT01098747|141716668|SUPERIORITY_OR_OTHER||LS mean difference|-0.23||||0.151|TWO_SIDED|95.0|-0.54|0.08||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.08|-0.54|0.151
70850628|NCT02712047|141189438|OTHER||Mean Difference (Net)|18.87|||||TWO_SIDED|95.0|-3.89|41.63|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 15, PM|||41.63|-3.89|
70850629|NCT02712047|141189438|OTHER||Mean Difference (Net)|6.35|||||TWO_SIDED|95.0|-16.17|28.88|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 16, AM|||28.88|-16.17|
71015240|NCT00762073|141537875|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.239||||0.5282|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.5282
71015241|NCT00762073|141537875|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|18.86||||0.0092|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.0092
71015242|NCT00762073|141537875|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|15.009||||0.0174|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.0174
71015243|NCT00762073|141537876|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1786|TWO_SIDED|||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic|||||||0.1786
71015244|NCT00762073|141537876|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED|||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic|||||||0.0090
71015245|NCT00762073|141537876|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|TWO_SIDED|||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic|||||||0.0001
71015246|NCT00762073|141537877|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4959|TWO_SIDED|||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic|||||||0.4959
71015247|NCT00762073|141537877|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic|||||||0.0040
71015248|NCT00762073|141537877|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic|||||||<0.0001
71015249|NCT00762073|141537878|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0108|TWO_SIDED|||||p-values comparing percent change from baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.0108
71015250|NCT00762073|141537878|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0208|TWO_SIDED|||||p-values comparing percent change from baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.0208
70850630|NCT02712047|141189438|OTHER||Mean Difference (Net)|19.07|||||TWO_SIDED|95.0|-3.27|41.41|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 16, PM|||41.41|-3.27|
71104610|NCT01098747|141716668|SUPERIORITY_OR_OTHER||LS mean difference|1.88|||<|0.001|TWO_SIDED|95.0|1.43|2.33||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.33|1.43|<0.001
70930030|NCT04881461|141357819|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.4438|TWO_SIDED|95.0|-0.12|0.27||Observed P-value|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||0.27|-0.12|0.4438
70930031|NCT04881461|141357820|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.0363|TWO_SIDED|95.0|0.01|0.38||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||0.38|0.01|0.0363
70930032|NCT04881461|141357821|SUPERIORITY||Mean Difference (Final Values)|1.19||||0.0329|TWO_SIDED|95.0|0.06|2.31||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand.."||2.31|0.06|0.0329
70930033|NCT04881461|141357822|SUPERIORITY||Mean Difference (Final Values)|1.73||||0.0016|TWO_SIDED|95.0|0.66|2.79||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||2.79|0.66|0.0016
71104611|NCT01098747|141716668|SUPERIORITY_OR_OTHER||LS mean difference|-0.23||||0.16|TWO_SIDED|95.0|-0.56|0.09||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.09|-0.56|0.160
71104612|NCT01098747|141716668|SUPERIORITY_OR_OTHER||LS mean difference|1.63|||<|0.001|TWO_SIDED|95.0|1.16|2.1||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.10|1.16|<0.001
71104613|NCT01098747|141716668|SUPERIORITY_OR_OTHER||LS mean difference|-0.33||||0.055|TWO_SIDED|95.0|-0.67|0.01||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.01|-0.67|0.055
71104614|NCT01098747|141716668|SUPERIORITY_OR_OTHER||LS mean difference|1.39|||<|0.001|TWO_SIDED|95.0|0.91|1.88||p-value was calculated using ANOVA model with treatment, baseline PSR and gender PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||1.88|0.91|<0.001
70930034|NCT04881461|141357823|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.4502|TWO_SIDED|95.0|-0.42|0.92||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||0.92|-0.42|0.4502
70930035|NCT04881461|141357824|SUPERIORITY||Mean Difference (Final Values)|0.55||||0.1177|TWO_SIDED|95.0|-0.14|1.23||Observed P-value|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||1.23|-0.14|0.1177
71015251|NCT00762073|141537878|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||p-values comparing percent change from baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||<0.0001
71104615|NCT01098747|141716668|SUPERIORITY_OR_OTHER||LS mean difference|-0.37||||0.04|TWO_SIDED|95.0|-0.71|-0.02||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||-0.02|-0.71|0.040
71104616|NCT01098747|141716668|SUPERIORITY_OR_OTHER||LS mean difference|1.2|||<|0.001|TWO_SIDED|95.0|0.71|1.69||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||1.69|0.71|<0.001
71104617|NCT01098747|141716668|SUPERIORITY_OR_OTHER||LS mean difference|-0.44||||0.015|TWO_SIDED|95.0|-0.79|-0.08||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||-0.08|-0.79|0.015
71015252|NCT00762073|141537879|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1095|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate|ANCOVA|||||||0.1095
71015253|NCT00762073|141537879|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0264|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate|ANCOVA|||||||0.0264
71015254|NCT00762073|141537879|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate|ANCOVA|||||||0.0010
71015255|NCT00762073|141537880|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3769|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.3769
71015256|NCT00762073|141537880|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9363|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.9363
71015257|NCT00762073|141537880|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1235|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.1235
71015258|NCT00762073|141537881|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3444|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.3444
71015259|NCT00762073|141537881|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9258|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.9258
71015260|NCT00762073|141537881|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3215|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.3215
71015261|NCT00762073|141537882|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6729|TWO_SIDED|||||p-values comparing percent change from Baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.6729
71104618|NCT01098747|141716669|SUPERIORITY_OR_OTHER||LS mean difference|0.3|||<|0.001|TWO_SIDED|95.0|0.13|0.46||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.46|0.13|<0.001
70850631|NCT02712047|141189438|OTHER||Mean Difference (Net)|29.51|||||TWO_SIDED|95.0|6.87|52.15|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 17, AM|||52.15|6.87|
70850632|NCT02712047|141189438|OTHER||Mean Difference (Net)|9.64|||||TWO_SIDED|95.0|-17.91|37.19|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 17, PM|||37.19|-17.91|
71015262|NCT00762073|141537882|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8894|TWO_SIDED|||||p-values comparing percent change from Baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.8894
71015263|NCT00762073|141537882|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1532|TWO_SIDED|||||p-values comparing percent change from Baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.1532
71015264|NCT00762073|141537883|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4197|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.4197
71015265|NCT00762073|141537883|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9787|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.9787
71015266|NCT00762073|141537883|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8987|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.8987
71015267|NCT00326625|141537891|SUPERIORITY||Slope difference|-0.06|STANDARD_ERROR_OF_MEAN|0.083||0.4807|TWO_SIDED|95.0|-0.22|0.1|||ANCOVA||Glatiramer acetate vs. Placebo|Analysis compares the ALSFRS-R slopes of change from baseline between treatment groups. Analysis includes the following covariates: time from randomization, treatment group, time by treatment interaction, center, Riluzole use, age, site of ALS onset, time from ALS onset and baseline ALSFRS-R score.||0.10|-0.22|0.4807
71015268|NCT00326625|141537892|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.8583|TWO_SIDED|95.0|0.56|2.005|||Regression, Cox||Glatiramer acetate vs. Placebo|Analysis covariates are center, riluzole use, site of ALS onset, time from ALS onset, baseline ALSFRS-R score, baseline slow vital capacity (VC) and baseline body mass index (BMI).||2.005|0.560|0.8583
71015269|NCT01265875|141537893|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||t-test, 2 sided|||Change from baseline to day 4.||||.25
71015270|NCT01265875|141537893|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||t-test, 2 sided|||Change from baseline to day 7.||||.19
71015271|NCT01265875|141537893|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||t-test, 2 sided|||Change from baseline to Day 30.||||.27
71015272|NCT01265875|141537895|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||t-test, 2 sided|||Change from baseline to Day 4.||||.52
71015273|NCT01265875|141537895|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||t-test, 2 sided|||Change from baseline to Day 30.||||.34
71015274|NCT04456998|141537903|SUPERIORITY||Mean Difference (Net)|-96.1||||0.031|TWO_SIDED|95.0|-183.5|-8.8|||ANCOVA||GB002 vs. Placebo|||-8.8|-183.5|0.0310
71015275|NCT04456998|141537904|SUPERIORITY||Mean Difference (Net)|6.5||||0.5972|TWO_SIDED|95.0|-17.9|30.9|||Mixed Models Analysis||GB002 vs. Placebo|||30.9|-17.9|0.5972
71015276|NCT03179462|141537929|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
70850633|NCT02712047|141189438|OTHER||Mean Difference (Net)|24.77|||||TWO_SIDED|95.0|-4.2|53.73|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 18, AM|||53.73|-4.20|
70850634|NCT02712047|141189438|OTHER||Mean Difference (Net)|47.04|||||TWO_SIDED|95.0|14.63|79.45|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 18, PM|||79.45|14.63|
70930036|NCT04881461|141357825|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.4604|TWO_SIDED|95.0|-0.37|0.79||Observed P-value|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||0.79|-0.37|0.4604
70930037|NCT04881461|141357826|SUPERIORITY||Mean Difference (Final Values)|0.57||||0.0549|TWO_SIDED|95.0|-0.01|1.15||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||1.15|-0.01|0.0549
70930038|NCT04881461|141357827|SUPERIORITY||Mean Difference (Final Values)|1.12||||0.0049|TWO_SIDED|95.0|0.3|1.93||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||1.93|0.30|0.0049
71015277|NCT03743571|141537933|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham).||||||0.42||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,24) = 0.67, p = 0.42||We used a null hypothesis significance testing approach in our analyses. For performance on Behavioral Approach Tests (BATs), we completed 2 x 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham), time (within subjects variable; baseline vs follow-up), and audience type (ethnicity primary matched vs unmatched to the participants' own identity) on outcome measures.||||.42
71015278|NCT03743571|141537934|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham).||||||0.88||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,24) = 0.02, p = .88.||We used a null hypothesis significance testing approach in our analyses. For performance on Behavioral Approach Tests (BATs), we completed 2 x 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham), time (within subjects variable; baseline vs follow-up), and audience type (ethnicity primary matched vs unmatched to the participants' own identity) on outcome measures.||||.88
71015279|NCT03743571|141537935|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham).||||||0.17||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,24) = 1.98, p = .17||We used a null hypothesis significance testing approach in our analyses. For performance on Behavioral Approach Tests (BATs), we completed 2 x 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham), time (within subjects variable; baseline vs follow-up), and audience type (ethnicity primary matched vs unmatched to the participants' own identity) on outcome measures.||||.17
71015280|NCT03743571|141537936|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham).||||||0.42||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,24) = 0.67, p = 0.42.||We used a null hypothesis significance testing approach in our analyses. For performance on Behavioral Approach Tests (BATs), we completed 2 x 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham), time (within subjects variable; baseline vs follow-up), and audience type (ethnicity primary matched vs unmatched to the participants' own identity) on outcome measures.||||.42
71015281|NCT03743571|141537937|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham).||||||0.88||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,24) = 0.02, p = .88.||We used a null hypothesis significance testing approach in our analyses. For performance on Behavioral Approach Tests (BATs), we completed 2 x 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham), time (within subjects variable; baseline vs follow-up), and audience type (ethnicity primary matched vs unmatched to the participants' own identity) on outcome measures.||||.88
71104619|NCT01098747|141716669|SUPERIORITY_OR_OTHER||LS mean difference|0.22|||<|0.001|TWO_SIDED|95.0|0.11|0.34||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.34|0.11|<0.001
70850635|NCT02712047|141189438|OTHER||Mean Difference (Net)|20.11|||||TWO_SIDED|95.0|-12.3|52.52|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 19, AM|||52.52|-12.30|
71015282|NCT03743571|141537938|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham).||||||0.17||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,24) = 1.98, p = .17.||We used a null hypothesis significance testing approach in our analyses. For performance on Behavioral Approach Tests (BATs), we completed 2 x 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham), time (within subjects variable; baseline vs follow-up), and audience type (ethnicity primary matched vs unmatched to the participants' own identity) on outcome measures.||||.17
71015283|NCT03743571|141537939|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham).||||||0.67||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,26) = 0.19, p = .67||We used a null hypothesis significance testing approach in our analyses. For performance on the questionnaires, we completed 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham) and time (within subjects variable; baseline vs follow-up) on outcome measures.||||.67
71015284|NCT03743571|141537940|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham).||||||0.96||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,26) \< .01, p = .96||We used a null hypothesis significance testing approach in our analyses. For performance on the questionnaires, we completed 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham) and time (within subjects variable; baseline vs follow-up) on outcome measures.||||.96
71015285|NCT03743571|141537941|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham),||||||0.43||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,26) = 0.65, p = .43||We used a null hypothesis significance testing approach in our analyses. For performance on the questionnaires, we completed 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham) and time (within subjects variable; baseline vs follow-up) on outcome measures.||||.43
71015286|NCT04115488|141537942|EQUIVALENCE|Data was analyzed using a negative binomial model with a logarithmic link function and fixed effects for the treatment group and stratification factors. Equivalence was tested based 95% confidence interval.|Exponentiated Difference|0.17|STANDARD_ERROR_OF_MEAN|0.397|||TWO_SIDED|95.0|-0.613|0.944|||||Difference calculated as Tysabri minus PB006.|||0.944|-0.613|
71015287|NCT01821391|141538040|SUPERIORITY||||||=|0.2665|||||||Paired Student's t test|||||||=0.2665
71015288|NCT04880850|141538094|NON_INFERIORITY|Non-inferiority of insulin icodec was considered confirmed if the upper limit of the two-sided 95% confidence interval (CI) for mean treatment difference (insulin icodec minus insulin glargine) was strictly below 0.3%.|Treatment difference|0.02|||<|0.0001|TWO_SIDED|95.0|-0.11|0.15|||ANCOVA|||The response and change from baseline in response after 26 weeks were analysed using an analysis of covariance (ANCOVA) model with treatment, region and personal continuous glucose monitoring (CGM) device use as fixed factors, and baseline response as covariate.||0.15|-0.11|<0.0001
71015289|NCT03417102|141538104|SUPERIORITY||ABR ratio|0.092|||<|0.0001|TWO_SIDED|95.0|0.044|0.192||P-value derived from NB regression model, accounted for different follow-up times during EP, with treatment arm and randomization strata of number of bleeds in 6 months prior to study (\<=10,\>10) as fixed effects. Significance threshold was 0.05.|Negative binomial regression model|||||0.192|0.044|<0.0001
71015290|NCT03417102|141538106|SUPERIORITY||ABR ratio|0.108|||<|0.0001|TWO_SIDED|95.0|0.056|0.207||P-value derived from NB regression model, accounted for different follow-up times during TP, with treatment arm and randomization strata of number of bleeds in 6 months prior to study (\<=10,\>10) as fixed effects. Significance threshold was 0.05.|Negative binomial regression model|||||0.207|0.056|<0.0001
71015291|NCT03417102|141538108|SUPERIORITY||ABR ratio|0.056|||<|0.0001|TWO_SIDED|95.0|0.026|0.121||P-value derived from NB regression model, accounted for different follow-up times during EP, with treatment arm and randomization strata of number of bleeds in 6 months prior to study (\<=10,\>10) as fixed effects. Significance threshold was 0.05.|Negative binomial regression model|||||0.121|0.026|<0.0001
71015292|NCT03417102|141538110|SUPERIORITY||ABR ratio|0.098|||<|0.0001|TWO_SIDED|95.0|0.046|0.21||P-value derived from NB regression model, accounted for different follow-up times during EP, with treatment arm and randomization strata of number of bleeds in 6 months prior to study (\<=10,\>10) as fixed effects. Significance threshold was 0.05.|Negative binomial regression model|||||0.210|0.046|<0.0001
71049534|NCT02504671|141606189|OTHER||Difference|24.3|||||TWO_SIDED|95.0|3.5|45.2|||||Week 6, ACR20. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||45.2|3.5|
70850636|NCT02712047|141189438|OTHER||Mean Difference (Net)|25.13|||||TWO_SIDED|95.0|-15.02|65.27|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 19, PM|||65.27|-15.02|
71015293|NCT03417102|141538112|SUPERIORITY||Least Square (LS) Mean difference|-28.72|||<|0.0001|TWO_SIDED|95.0|-39.07|-18.37||Analysis of Covariance (ANCOVA) model included treatment arm and randomization strata of number of bleeds (\<=10, \> 10) as fixed effects, Baseline score as a covariate. Significance threshold was at 0.05.|ANCOVA|||||-18.37|-39.07|<0.0001
71049535|NCT02504671|141606189|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-12.2|17.6|||||Week 6, ACR50. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||17.6|-12.2|
71049536|NCT02504671|141606189|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-12.2|17.6|||||Week 6, ACR50. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||17.6|-12.2|
71015294|NCT03417102|141538113|SUPERIORITY||LS Mean difference|-14.85|||<|0.0001|TWO_SIDED|95.0|-21.37|-8.33||ANCOVA model included treatment arm and randomization strata of number of bleeds (\<=10, \> 10) as fixed effects, Baseline score as a covariate. Significance threshold was at 0.05.|ANCOVA|||||-8.33|-21.37|<0.0001
71015295|NCT00526227|141538117|OTHER|An exact one-sided 97% upper confidence bound or a p-value will be calculated based on the observed percentage of subjects with an USADE within the first month post-implant. This rate will be considered acceptable if the one-sided 97% upper confidence bound is less than 10% or, equivalently, if the p-value is less than 0.0304.|Percentage|7.7|||||ONE_SIDED|97.0|||||||The CI was calculated based on 44 patients at interim analysis: 0 USADE were reported within 1-month post implant, ie 0% of subjects experienced a USADE. The one-sided 97% exact binomial upper confidence bound was 7.7% which is lower than 10%.|"H 0 (null hypothesis): P ≥ 10%; H A (alternative hypothesis): P \< 10%, where P is the percentage of subjects experiencing a USADE through the 1-month post implant.~An upper limit of the confidence interval of the percentage subjects with USADE not greater than or equal to 10% at the 1-month follow-up visit provides a reasonably-sized clinical study with sufficient power to detect USADEs."||||
71015296|NCT06212544|141538122|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71015297|NCT03315780|141538144|SUPERIORITY||Mean Difference (Final Values)|-254.02|||<|0.0001|TWO_SIDED|95.0|-337.76|-170.28|||Mixed Models Analysis|||||-170.28|-337.76|< 0.0001
71015298|NCT03315780|141538147|SUPERIORITY||Mean Difference (Final Values)|27.46||||0.01|TWO_SIDED|95.0|8.05|46.87|||Mixed Models Analysis|||||46.87|8.05|0.0100
71015299|NCT03315780|141538148|SUPERIORITY||Mean Difference (Final Values)|3.72||||0.0263|TWO_SIDED|95.0|0.63|6.81|||Mixed Models Analysis|||||6.81|0.63|0.0263
71015300|NCT03315780|141538149|SUPERIORITY||Mean Difference (Final Values)|-9.36||||0.08|TWO_SIDED|95.0|-20.16|1.43|||Mixed Models Analysis|||||1.43|-20.16|0.0800
71015301|NCT03315780|141538150|SUPERIORITY||Mean Difference (Final Values)|-15.39||||0.7475|TWO_SIDED|95.0|-118.35|87.57|||Mixed Models Analysis|||||87.57|-118.35|0.7475
71015302|NCT01361308|141538152|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Week 4 frequency|Rank transformed ANCOVA|||||||<0.0001
71015303|NCT01361308|141538152|SUPERIORITY_OR_OTHER|||||||0.009||||||Week 12 frequency|Rank transformed ANCOVA|||||||0.0090
71015304|NCT01361308|141538153|SUPERIORITY_OR_OTHER|||||||0.001||||||Clinical meaningfulness at week 4|Logit model|||||||0.001
71015305|NCT01361308|141538153|SUPERIORITY_OR_OTHER|||||||0.055||||||Clinical meaningfulness at week 12|Logit model|||||||0.055
71015306|NCT01361308|141538169|SUPERIORITY_OR_OTHER|||||||0.0017||||||Week 4 severity|Rank transformed ANCOVA|||||||0.0017
71015307|NCT01361308|141538169|SUPERIORITY_OR_OTHER|||||||0.1658||||||Week 12 severity|Rank transformed ANCOVA|||||||0.1658
71015308|NCT03965754|141538187|SUPERIORITY||Odds Ratio (OR)|5.96|||<|0.001|TWO_SIDED|95.0|4.0|9.18||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the three email conditions as dummy variables with no email as the reference group (among employees who previously enrolled in the program).||9.18|4.00|<.001
71015309|NCT03965754|141538187|SUPERIORITY||Odds Ratio (OR)|5.02|||<|0.001|TWO_SIDED|95.0|3.36|7.76||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the three email conditions as dummy variables with no email as the reference group (among employees who previously enrolled in the program).||7.76|3.36|<.001
71015310|NCT03965754|141538187|SUPERIORITY||Odds Ratio (OR)|3.3|||<|0.001|TWO_SIDED|95.0|2.17|5.17||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the three email conditions as dummy variables with no email as the reference group (among employees who previously enrolled in the program).||5.17|2.17|<.001
71015311|NCT03965754|141538187|SUPERIORITY||Odds Ratio (OR)|3.28||||0.038|TWO_SIDED|95.0|1.16|11.71||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the three email conditions as dummy variables with no email as the reference group (among employees who never enrolled in the program).||11.71|1.16|.038
71015312|NCT03965754|141538187|SUPERIORITY||Odds Ratio (OR)|2.01||||0.256|TWO_SIDED|95.0|0.63|7.54||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the three email conditions as dummy variables with no email as the reference group (among employees who never enrolled in the program).||7.54|0.63|.256
71015313|NCT03965754|141538187|SUPERIORITY||Odds Ratio (OR)|1.5||||0.531|TWO_SIDED|95.0|0.43|5.89||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the three email conditions as dummy variables with no email as the reference group (among employees who never enrolled in the program).||5.89|0.43|.531
71015314|NCT03965754|141538187|SUPERIORITY||Odds Ratio (OR)|1.19||||0.202|TWO_SIDED|95.0|0.91|1.54||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who previously enrolled in the program).||1.54|0.91|.202
71015315|NCT03965754|141538187|SUPERIORITY||Odds Ratio (OR)|0.66||||0.005|TWO_SIDED|95.0|0.49|0.88||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who previously enrolled in the program).||0.88|0.49|.005
71015316|NCT03965754|141538187|SUPERIORITY||Odds Ratio (OR)|0.75||||0.276|TWO_SIDED|95.0|0.69|4.16||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who never enrolled in the program).||4.16|0.69|.276
71015317|NCT03965754|141538187|SUPERIORITY||Odds Ratio (OR)|0.75||||0.592|TWO_SIDED|95.0|0.25|2.16||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who never enrolled in the program).||2.16|0.25|.592
71015318|NCT03965754|141538188|SUPERIORITY|We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who previously enrolled).|Odds Ratio (OR)|1.31||||0.02|TWO_SIDED|95.0|1.04|1.65||We used an a priori threshold of p \< .05.|Regression, Logistic|||||1.65|1.04|.020
71015319|NCT03965754|141538188|SUPERIORITY||Odds Ratio (OR)|0.58|||<|0.001|TWO_SIDED|95.0|0.44|0.75||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who previously enrolled).||0.75|0.44|<.001
71049537|NCT02504671|141606189|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 6, ACR70. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71015320|NCT03965754|141538188|SUPERIORITY||Odds Ratio (OR)|0.75||||0.359|TWO_SIDED|95.0|0.41|1.38||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who never enrolled).||1.38|0.41|.359
71015321|NCT03965754|141538188|SUPERIORITY|We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who never enrolled).|Odds Ratio (OR)|1.72||||0.035|TWO_SIDED|95.0|1.05|2.9|||Regression, Logistic|We used an a priori threshold of p \< .05.||||2.90|1.05|.035
71015322|NCT02983305|141538189|EQUIVALENCE|Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms at baseline.||||||0.0001||||||P \< .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Test of equivalence of visual field area at baseline.||||.0001
71015323|NCT02983305|141538189|EQUIVALENCE|Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms under intervention conditions.||||||0.0001||||||P \< .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Test of equivalence of visual field area under intervention conditions.||||0.0001
71049538|NCT02504671|141606189|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 6, ACR70. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71015324|NCT02983305|141538189|EQUIVALENCE|Mann-Whitney U test was used to test non-equivalence of this outcome measure for the two study arms under intervention conditions.||||||0.003||||||P \< .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Comparison between study arms of the change in the visual field area (average of both eyes) detected between baseline and intervention.||||.003
71015325|NCT02983305|141538190|EQUIVALENCE|Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms at baseline.||||||0.38||||||P \< .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Test of equivalence of gait speed at baseline.||||0.38
71015326|NCT02983305|141538190|EQUIVALENCE|Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms under intervention conditions.||||||0.27||||||P \< .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Test of equivalence of gait speed under intervention conditions.||||0.27
71015327|NCT02983305|141538190|EQUIVALENCE|Mann-Whitney U test was used to test non-equivalence of this outcome measure for the two study arms under intervention conditions.||||||0.79||||||P \< .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Comparison between study arms of the change in the gait speed detected between baseline and intervention.||||0.79
71015328|NCT00706901|141538191|NON_INFERIORITY_OR_EQUIVALENCE|Zero-inflated Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.|||||<|0.01|TWO_SIDED||||||Zero inflated Poisson model|||||||<0.01
71015329|NCT00706901|141538191|NON_INFERIORITY_OR_EQUIVALENCE|Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.||||||0.02|TWO_SIDED||||||zero-hurdle Poisson model|||||||0.02
71015330|NCT00706901|141538192|NON_INFERIORITY_OR_EQUIVALENCE|A Zero-inflated Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.|||||<|0.01|TWO_SIDED||||||Zero inflated Poisson model|||||||<0.01
71015331|NCT00706901|141538192|NON_INFERIORITY_OR_EQUIVALENCE|Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.||||||0.0002|TWO_SIDED||||||Zero-hurdle Poisson model|||||||.0002
71015332|NCT00706901|141538193|NON_INFERIORITY_OR_EQUIVALENCE|To examine differences between GMI and TCC on SECs, a two-component Weibull mixture model for effectively dealing with zero-heavy continuous data was conducted.||||||0.04|TWO_SIDED||||||Weibull mixture model|||||||0.04
71049539|NCT02504671|141606189|OTHER||Difference|32.4|||||TWO_SIDED|95.0|12.4|52.4|||||Week 8, ACR20. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||52.4|12.4|
71049540|NCT02504671|141606189|OTHER||Difference|35.1|||||TWO_SIDED|95.0|15.1|55.1|||||Week 8, ACR20. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||55.1|15.1|
71049541|NCT02504671|141606189|OTHER||Difference|21.6|||||TWO_SIDED|95.0|6.8|36.4|||||Week 8, ACR50. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||36.4|6.8|
71049542|NCT02504671|141606189|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 8, ACR50. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
70850637|NCT02712047|141189438|OTHER||Mean Difference (Net)|-7.89|||||TWO_SIDED|95.0|-48.04|32.25|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 20, AM|||32.25|-48.04|
71049543|NCT02504671|141606189|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 8, ACR70. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71049544|NCT02504671|141606189|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 8, ACR70. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71049545|NCT02504671|141606189|OTHER||Difference|29.7|||||TWO_SIDED|95.0|11.0|48.4|||||Week 12, ACR20. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.4|11.0|
71049546|NCT02504671|141606189|OTHER||Difference|40.5|||||TWO_SIDED|95.0|21.6|59.5|||||Week 12, ACR20. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||59.5|21.6|
70930039|NCT04881461|141357828|SUPERIORITY||Mean Difference (Final Values)|1.24||||0.0004|TWO_SIDED|95.0|0.54|1.95||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||1.95|0.54|0.0004
71049547|NCT02504671|141606189|OTHER||Difference|21.6|||||TWO_SIDED|95.0|4.5|38.8|||||Week 12, ACR50. Difference to Placebo is presented for Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||38.8|4.5|
70930040|NCT04881461|141357829|SUPERIORITY||Mean Difference (Final Values)|0.94||||0.0054|TWO_SIDED|95.0|0.25|1.63||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||1.63|0.25|0.0054
71049548|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-2.4|29.4|||||Week 12, ACR50. Difference to Placebo is presented for Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.4|-2.4|
71049549|NCT02504671|141606189|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-8.7|14.1|||||Week 12, ACR70. Difference to Placebo is presented for Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||14.1|-8.7|
71049550|NCT02504671|141606189|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-7.0|17.8|||||Week 12, ACR70. Difference to Placebo is presented for Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||17.8|-7.0|
71049551|NCT02504671|141606189|OTHER||Difference|24.3|||||TWO_SIDED|95.0|4.5|44.1|||||Week 16, ACR20. Difference to Placebo is presented for Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||44.1|4.5|
71049552|NCT02504671|141606189|OTHER||Difference|51.4|||||TWO_SIDED|95.0|32.2|70.5|||||Week 16, ACR20. Difference to Placebo is presented for Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||70.5|32.2|
71049553|NCT02504671|141606189|OTHER||Difference|18.9|||||TWO_SIDED|95.0|2.1|35.7|||||Week 16, ACR50. Difference to Placebo is presented for Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||35.7|2.1|
71049554|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-2.4|29.4|||||Week 16, ACR50. Difference to Placebo is presented for Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.4|-2.4|
71049555|NCT02504671|141606189|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-7.0|17.8|||||Week 16, ACR70. Difference to Placebo is presented for Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||17.8|-7.0|
71049556|NCT02504671|141606189|OTHER||Difference|21.6|||||TWO_SIDED|95.0|2.0|41.2|||||Week 20, ACR20. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||41.2|2.0|
71049557|NCT02504671|141606189|OTHER||Difference|43.2|||||TWO_SIDED|95.0|23.5|63.0|||||Week 20, ACR20. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||63.0|23.5|
71049558|NCT02504671|141606189|OTHER||Difference|24.3|||||TWO_SIDED|95.0|6.9|41.8|||||Week 20, ACR50. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||41.8|6.9|
71049559|NCT02504671|141606189|OTHER||Difference|21.6|||||TWO_SIDED|95.0|4.5|38.8|||||Week 20, ACR50. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||38.8|4.5|
71049560|NCT02504671|141606189|OTHER||Difference|18.9|||||TWO_SIDED|95.0|3.3|34.5|||||Week 20, ACR70. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||34.5|3.3|
71049561|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Week 20, ACR70. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
71049562|NCT02504671|141606189|OTHER||Difference|27.0|||||TWO_SIDED|95.0|7.7|46.3|||||Week 24, ACR20. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||46.3|7.7|
71049563|NCT02504671|141606189|OTHER||Difference|45.9|||||TWO_SIDED|95.0|26.7|65.2|||||Week 24, ACR20. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||65.2|26.7|
71049564|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-3.6|30.6|||||Week 24, ACR50. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||30.6|-3.6|
71049565|NCT02504671|141606189|OTHER||Difference|16.2|||||TWO_SIDED|95.0|-1.2|33.7|||||Week 24, ACR50. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.7|-1.2|
71049566|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Week 24, ACR70. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
71049567|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Week 24, ACR70. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
70930041|NCT04881461|141357830|SUPERIORITY||Mean Difference (Final Values)|1.11||||0.0002|TWO_SIDED|95.0|0.52|1.71||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||1.71|0.52|0.0002
70930042|NCT05970861|141357834|OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||"Null hypothesis: there is no statistical significance between the mean percentages of microbiota units of the main and control groups after the mare's milk administration.~Alternate hypothesis: statistical significance exists between the mean percentages of microbiota units of the main and control groups after the mare's milk administration."||||<0.05
70930043|NCT05970861|141357834|OTHER||||||<|0.05|||||||ANOVA|||"Null Hypothesis: The freeze-dried mare's milk does not significantly influence the mean percentages of gut microbiota units.~Alternate Hypothesis: The freeze-dried mare's milk significantly influences the mean percentages of gut microbiota units."||||<0.05
70930044|NCT05970861|141357835|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Null hypothesis: No statistically significant difference exists between antiphospholipid antibody levels before and after the mare's milk administration.~Alternate hypothesis: Statistically significant difference exists between antiphospholipid antibody levels before and after the mare's milk administration."||||>0.05
70930045|NCT05970861|141357836|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||"Null hypothesis: No statistically significant difference exists between uric acid blood levels before and after the mare's milk administration.~Alternate hypothesis: Statistically significant difference exists between uric acid blood levels before and after the mare's milk administration."||||0.01
70930046|NCT05970861|141357837|OTHER||||||<|0.01|||||||t-test, 2 sided|||"Null hypothesis: No statistically significant difference exists between the scores on a scale (PCS, MCS) after the mare's milk administration.~Alternate hypothesis: Statistically significant difference exists between the scores on a scale (PCS, MCS) after the mare's milk administration."||||<0.01
70930047|NCT05970861|141357837|OTHER||||||>|0.05|||||||t-test, 2 sided|||"Null hypothesis: No statistically significant difference exists between the scores on a scale (PCS, MCS) after 2 measurements in the control group.~Alternate hypothesis: Statistically significant difference exists between the scores on a scale (PCS, MCS) after 2 measurements in the control group."||||>0.05
70930048|NCT05970861|141357837|OTHER||||||<|0.01|||||||ANOVA|||"Null Hypothesis: The freeze-dried mare's milk does not significantly influence the scores on the scales (PCS, MCS).~Alternate Hypothesis: The freeze-dried mare's milk significantly influences the scores on the scales (PCS, MCS)."||||<0.01
70930049|NCT00677365|141357857|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.96||||0.0014|TWO_SIDED|95.0|-1.54|-0.38||Repeated Measure Model|Mixed Models Analysis|||LS Mean Difference||-0.38|-1.54|0.0014
70930050|NCT00677365|141357858|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.21||||0.0007|TWO_SIDED|95.0|0.09|0.52|||Regression, Cox|||Hazard Ratio for need of anti-pseudomonal antimicrobials; Estimates are obtained from a Cox proportional hazards regression model including terms for treatment, region, baseline P.aeruginosa density (log10 ), highest baseline MIC of levofloxacin against P. aeruginosa (log2 ), and baseline percent predicted FEV1 (quartiles)||0.52|0.09|0.0007
70930051|NCT00677365|141357859|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.61||||0.0026|TWO_SIDED|95.0|3.05|14.17|||Mixed Models Analysis|||LS Mean Difference Between MP-376 240 mg and Placebo groups||14.17|3.05|0.0026
70930052|NCT00677365|141357860|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.94||||0.0008|TWO_SIDED|95.0|4.63|17.25|||Mixed Models Analysis|||LS Mean Difference Between Placebo and MP-376 240 mg BID groups||17.25|4.63|0.0008
70930053|NCT00677365|141357861|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.5||||0.2174|TWO_SIDED|95.0|-2.68|11.67|||Mixed Models Analysis|||LS Mean Difference from MP-376 240 mg BID to placebo groups||11.67|-2.68|0.2174
70930054|NCT02542631|141357898|NON_INFERIORITY|The sample size determination was based on the primary endpoint, A1C change from Baseline to Week 24. Assuming that the true mean difference in A1C change for Finesse versus Pen was -0.1% with a SD of 1.2%, a study population of 250 completers (125 per arm) was required to achieve a power of 90% for non-inferiority with a margin of 0.4%.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.32|0.14||Non-inferiority p-value was calculated with 2-sided comparison of the difference in treatment effects between Finesse and Pen with a non-inferiority margin of 0.4%.|ANCOVA|ANCOVA model with treatment group as a factor and baseline value as a covariate was used to compare devices for continuous measures.||||0.14|-0.32|<0.0001
70930055|NCT02542631|141357899|SUPERIORITY||Odds Ratio (OR)|1.3|STANDARD_ERROR_OF_MEAN|0.25||0.26|TWO_SIDED|95.0|0.81|2.14||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|Cochran-Mantel-Haenszel|||||2.14|0.81|0.26
70930056|NCT02542631|141357900|SUPERIORITY||Mean Difference (Final Values)|-2.97|STANDARD_ERROR_OF_MEAN|3.36||0.38|TWO_SIDED|95.0|-9.63|3.7||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|ANCOVA|ACNOVA model with treatment group as a factor and baseline value as a covariate was used to compare devices for continuous measures.||||3.70|-9.63|0.38
70930057|NCT02542631|141357901|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.99|TWO_SIDED|95.0|-0.28|0.28||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|ANCOVA|ANCOVA model with treatment group as a factor and baseline value as a covariate was used to compare devices for continuous measures.||||0.28|-0.28|0.99
70930058|NCT02542631|141357902|SUPERIORITY||Odds Ratio (OR)|1.1|STANDARD_ERROR_OF_MEAN|0.28||0.71|TWO_SIDED|95.0|0.64|1.93||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|Cochran-Mantel-Haenszel|||||1.93|0.64|0.71
71015333|NCT00706901|141538193|NON_INFERIORITY_OR_EQUIVALENCE|A generalized linear mixed model with correlated errors to account for correlation between repeated measurements of the response within subjects was conducted.||||||0.47|TWO_SIDED||||||Mixed Models Analysis|||||||0.47
71015334|NCT00706901|141538194|NON_INFERIORITY_OR_EQUIVALENCE|Zero inflated Poisson model with random intercept to account for correlation between repeated measurement of the responses within subjects was conducted.|||||<|0.01|TWO_SIDED||||||Zero inflated Poisson model|||||||<0.01
71015335|NCT00706901|141538194|NON_INFERIORITY_OR_EQUIVALENCE|Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.|||||<|0.0001|TWO_SIDED||||||Zero-hurdle Poisson model|||||||<.0001
71015336|NCT00706901|141538195|NON_INFERIORITY_OR_EQUIVALENCE|Zero inflated Poisson model with random intercept to account for correlation between repeated measurement of the responses within subjects was conducted.|||||<|0.0001|TWO_SIDED||||||Zero inflated Poisson model|||||||<.0001
71015337|NCT00706901|141538195|NON_INFERIORITY_OR_EQUIVALENCE|Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.||||||0.02|TWO_SIDED||||||Zero-hurdle Poisson model|||||||0.02
71015338|NCT00706901|141538196|NON_INFERIORITY_OR_EQUIVALENCE|Zero inflated Poisson model with random intercept to account for correlation between repeated measurement of the responses within subjects was conducted.||||||0.17|TWO_SIDED||||||Zero inflated Poisson model|||||||0.17
71015339|NCT00706901|141538196|NON_INFERIORITY_OR_EQUIVALENCE|Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.||||||0.67|TWO_SIDED||||||Zero-hurdle Poisson model|||||||0.67
71015340|NCT03433482|141538197|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% confidence interval (CI) for the hSBA GMT ratio for serogroup A between the MenACWY liquid vaccine aged for approximately 24 months and the licensed MenACWY vaccine is \> 0.5.|GMT ratio|1.21|||||TWO_SIDED|95.0|0.94|1.57|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and country as factors.||To demonstrate non-inferiority of the MenACWY liquid vaccine aged for approximately 24 months to that of currently licensed MenACWY vaccine, as measured by the adjusted hSBA GMTs directed against N. meningitidis serogroup A at Day 29 after a single dose vaccination||1.57|0.94|
71015341|NCT03433482|141538197|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% CI for the hSBA GMT ratios for serogroup A between the MenACWY liquid vaccine aged for approximately 30 months and the licensed MenACWY vaccine is \> 0.5. Non-inferiority hypotheses testing will be conducted sequentially, starting from MenACWY liquid vaccine aged for approximately 24 months and subsequently with MenACWY liquid vaccine aged for approximately 30 months.|GMT ratio|1.11|||||TWO_SIDED|95.0|0.87|1.42|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and country as factors.||To demonstrate non-inferiority of the MenACWY liquid vaccine aged for approximately 30 months to that of currently licensed MenACWY vaccine, as measured by the adjusted hSBA GMTs directed against N. meningitidis serogroup A at Day 29 after a single dose vaccination.||1.42|0.87|
71015342|NCT03433482|141538198|OTHER||GMT ratio|0.84|||||TWO_SIDED|95.0|0.58|1.19|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.||Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY\_Liq24 and ACWY\_1, at Day 29 against serogroup C||1.19|0.58|
71015343|NCT03433482|141538198|OTHER||GMT ratio|0.94|||||TWO_SIDED|95.0|0.72|1.24|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.||Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY\_Liq24 and ACWY\_1, at Day 29 against serogroup W||1.24|0.72|
71015344|NCT03433482|141538198|OTHER||GMT ratio|1.09|||||TWO_SIDED|95.0|0.82|1.44|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.||Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY\_Liq24 and ACWY\_1, at Day 29 against serogroup Y||1.44|0.82|
71015345|NCT03433482|141538198|OTHER||GMT ratio|1.14|||||TWO_SIDED|95.0|0.79|1.64|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.||Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY\_Liq30 and ACWY\_2, at Day 29 against serogroup C||1.64|0.79|
71015346|NCT03433482|141538198|OTHER||GMT ratio|1.1|||||TWO_SIDED|95.0|0.84|1.45|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.||Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY\_Liq30 and ACWY\_2, at Day 29 against serogroup W||1.45|0.84|
71015347|NCT03433482|141538198|OTHER||GMT ratio|0.96|||||TWO_SIDED|95.0|0.72|1.26|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.||Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY\_Liq30 and ACWY\_2, at Day 29 against serogroup Y||1.26|0.72|
71015348|NCT03433482|141538200|OTHER||Difference in percentage of subjects|2.21|||||TWO_SIDED|95.0|-1.94|6.4|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup A at Day 29.||6.40|-1.94|
71015349|NCT03433482|141538200|OTHER||Difference in percentage of subjects|-2.12|||||TWO_SIDED|95.0|-8.94|4.72|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup C at Day 29.||4.72|-8.94|
71015350|NCT03433482|141538200|OTHER||Difference in percentage of subjects|-1.16|||||TWO_SIDED|95.0|-8.11|5.8|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup W at Day 29.||5.80|-8.11|
71104620|NCT01098747|141716669|SUPERIORITY_OR_OTHER||LS mean difference|0.94|||<|0.001|TWO_SIDED|95.0|0.7|1.19||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.19|0.70|<0.001
71104621|NCT01098747|141716669|SUPERIORITY_OR_OTHER||LS mean difference|0.38|||<|0.001|TWO_SIDED|95.0|0.2|0.55||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.55|0.20|<0.001
71104622|NCT01098747|141716669|SUPERIORITY_OR_OTHER||LS mean difference|1.46|||<|0.001|TWO_SIDED|95.0|1.18|1.75||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.75|1.18|<0.001
71104623|NCT01098747|141716669|SUPERIORITY_OR_OTHER||LS mean difference|0.25||||0.017|TWO_SIDED|95.0|0.04|0.45||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.45|0.04|0.017
71104624|NCT01098747|141716669|SUPERIORITY_OR_OTHER||LS mean difference|1.67|||<|0.001|TWO_SIDED|95.0|1.39|1.96||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.96|1.39|<0.001
71104625|NCT01098747|141716669|SUPERIORITY_OR_OTHER||LS mean difference|0.25||||0.015|TWO_SIDED|95.0|0.05|0.46||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.46|0.05|0.015
71104626|NCT01098747|141716669|SUPERIORITY_OR_OTHER||LS mean difference|1.69|||<|0.001|TWO_SIDED|95.0|1.41|1.98||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.98|1.41|<0.001
71104627|NCT01098747|141716669|SUPERIORITY_OR_OTHER||LS mean difference|0.09||||0.362|TWO_SIDED|95.0|-0.11|0.3||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.30|-0.11|0.362
70850638|NCT02712047|141189438|OTHER||Mean Difference (Net)|8.51|||||TWO_SIDED|95.0|-37.22|54.25|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 20, PM|||54.25|-37.22|
71015351|NCT03433482|141538200|OTHER||Difference in percentage of subjects|-1.57|||||TWO_SIDED|95.0|-7.88|4.74|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup Y at Day 29.||4.74|-7.88|
71015352|NCT03433482|141538200|OTHER||Difference in percentage of subjects|-0.12|||||TWO_SIDED|95.0|-4.29|4.07|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup A at Day 29.||4.07|-4.29|
71104628|NCT01098747|141716669|SUPERIORITY_OR_OTHER||LS mean difference|1.56|||<|0.001|TWO_SIDED|95.0|1.27|1.86||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.86|1.27|<0.001
71104629|NCT01098747|141716669|SUPERIORITY_OR_OTHER||LS mean difference|-0.08||||0.472|TWO_SIDED|95.0|-0.29|0.14||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.14|-0.29|0.472
71104630|NCT01098747|141716669|SUPERIORITY_OR_OTHER||LS mean difference|1.39|||<|0.001|TWO_SIDED|95.0|1.07|1.7||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.70|1.07|<0.001
71104631|NCT01098747|141716669|SUPERIORITY_OR_OTHER||LS mean difference|-0.17||||0.134|TWO_SIDED|95.0|-0.4|0.05||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.05|-0.40|0.134
71104632|NCT01098747|141716669|SUPERIORITY_OR_OTHER||LS mean difference|1.31|||<|0.001|TWO_SIDED|95.0|1.0|1.63||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.63|1.00|<0.001
71104633|NCT01098747|141716669|SUPERIORITY_OR_OTHER||LS mean difference|-0.17||||0.135|TWO_SIDED|95.0|-0.4|0.05||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.05|-0.40|0.135
70850639|NCT02712047|141189438|OTHER||Mean Difference (Net)|15.08|||||TWO_SIDED|95.0|-28.5|58.67|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 21, AM|||58.67|-28.50|
70930059|NCT02542631|141357903|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.09||0.52|TWO_SIDED|95.0|-0.12|0.24||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|ANCOVA|ANCOVA model with treatment group as a factor and week 24 value as a covariate was used to compare devices for continuous measures.||||0.24|-0.12|0.52
70930060|NCT02542631|141357904|SUPERIORITY||Mean Difference (Final Values)|9.16|STANDARD_ERROR_OF_MEAN|2.8||0.001|TWO_SIDED|95.0|3.65|14.67||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|ANCOVA|ANCOVA model with change in score as dependent variable, treatment as factor, and baseline score as a covariate was used to compare devices.||||14.67|3.65|0.001
70930061|NCT02542631|141357905|SUPERIORITY||Mean Difference (Final Values)|4.32|STANDARD_ERROR_OF_MEAN|2.03||0.03|TWO_SIDED|95.0|0.33|8.32||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|ANCOVA|ANCOVA model with change in score as dependent variable, treatment as factor, and baseline score as a covariate was used to compare devices.||||8.32|0.33|0.03
70930062|NCT02542631|141357906|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.00
71015353|NCT03433482|141538200|OTHER||Difference in percentage of subjects|2.85|||||TWO_SIDED|95.0|-3.63|9.3|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup C at Day 29.||9.30|-3.63|
71015354|NCT03433482|141538200|OTHER||Difference in percentage of subjects|4.01|||||TWO_SIDED|95.0|-2.89|10.88|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup W at Day 29.||10.88|-2.89|
71015355|NCT03433482|141538200|OTHER||Difference in percentage of subjects|-2.84|||||TWO_SIDED|95.0|-8.91|3.26|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup Y at Day 29.||3.26|-8.91|
71015356|NCT03433482|141538201|OTHER||Difference in percentage of subjects|1.79|||||TWO_SIDED|95.0|-2.69|6.32|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A on Day 1.||6.32|-2.69|
71015357|NCT03433482|141538201|OTHER||Difference in percentage of subjects|6.96|||||TWO_SIDED|95.0|0.01|13.84|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C on Day 1.||13.84|0.01|
71015358|NCT03433482|141538201|OTHER||Difference in percentage of subjects|3.13|||||TWO_SIDED|95.0|-3.33|9.58|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W on Day 1.||9.58|-3.33|
71049568|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 28, ACR20. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049569|NCT02504671|141606189|OTHER||Difference|64.9|||||TWO_SIDED|95.0|48.9|80.8|||||Week 28, ACR20. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||80.8|48.9|
71104634|NCT01098747|141716669|SUPERIORITY_OR_OTHER||LS mean difference|1.17|||<|0.001|TWO_SIDED|95.0|0.84|1.5||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.50|0.84|<0.001
71104635|NCT01098747|141716669|SUPERIORITY_OR_OTHER||LS mean difference|-0.25||||0.036|TWO_SIDED|95.0|-0.49|-0.02||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||-0.02|-0.49|0.036
71015359|NCT03433482|141538201|OTHER||Difference in percentage of subjects|0.96|||||TWO_SIDED|95.0|-4.86|6.8|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y on Day 1.||6.80|-4.86|
70930063|NCT02641730|141357907|SUPERIORITY||Mean Difference (Final Values)|-7.69|STANDARD_ERROR_OF_MEAN|1.674|<|0.001|TWO_SIDED|95.0|-11.0|-4.383|||Mixed-Model for Repeated Measures|||||-4.383|-11.000|<0.001
70930064|NCT02641730|141357907|SUPERIORITY||Mean Difference (Final Values)|-4.11|STANDARD_ERROR_OF_MEAN|1.7||0.017|TWO_SIDED|95.0|-7.468|-0.748|||Mixed-Model for Repeated Measures|||||-0.748|-7.468|0.017
71015360|NCT03433482|141538201|OTHER||Difference in percentage of subjects|1.46|||||TWO_SIDED|95.0|-2.24|5.22|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A on Day 29.||5.22|-2.24|
71049570|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 28, ACR50. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049571|NCT02504671|141606189|OTHER||Difference|21.6|||||TWO_SIDED|95.0|6.8|36.4|||||Week 28, ACR50. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||36.4|6.8|
71049572|NCT02504671|141606189|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 28, ACR70. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
71049573|NCT02504671|141606189|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 28, ACR70. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71049574|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 32, ACR20. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
70930065|NCT05652010|141357948|OTHER|Comparative study|Odds Ratio (OR)|0.576||||0.164|TWO_SIDED|95.0|0.2634|1.2659||P=0.164 for testing the hypothesis that OR=1|Mixed Models Analysis|Generalized linear mixed model. As it was an exploratory study no adjustment for multiple comparison was performed.|P=0.164 for testing the hypothesis that OR=1|||1.2659|0.2634|0.164
71015361|NCT03433482|141538201|OTHER||Difference in percentage of subjects|-0.43|||||TWO_SIDED|95.0|-6.32|5.46|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C on Day 29.||5.46|-6.32|
71015362|NCT03433482|141538201|OTHER||Difference in percentage of subjects|-1.43|||||TWO_SIDED|95.0|-7.05|4.18|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W on Day 29.||4.18|-7.05|
71015363|NCT03433482|141538201|OTHER||Difference in percentage of subjects|2.04|||||TWO_SIDED|95.0|-2.81|6.9|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y on Day 29.||6.90|-2.81|
71015364|NCT03433482|141538201|OTHER||Difference in percentage of subjects|1.5|||||TWO_SIDED|95.0|-3.32|6.33|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A on Day 1.||6.33|-3.32|
71015365|NCT03433482|141538201|OTHER||Difference in percentage of subjects|0.38|||||TWO_SIDED|95.0|-6.6|7.35|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C on Day 1.||7.35|-6.60|
71015366|NCT03433482|141538201|OTHER||Difference in percentage of subjects|-1.26|||||TWO_SIDED|95.0|-7.75|5.23|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W on Day 1.||5.23|-7.75|
71015367|NCT03433482|141538201|OTHER||Difference in percentage of subjects|-0.85|||||TWO_SIDED|95.0|-6.69|4.98|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y on Day 1.||4.98|-6.69|
71015368|NCT03433482|141538201|OTHER||Difference in percentage of subjects|-0.64|||||TWO_SIDED|95.0|-4.24|2.96|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A on Day 29.||2.96|-4.24|
71015369|NCT03433482|141538201|OTHER||Difference in percentage of subjects|1.32|||||TWO_SIDED|95.0|-3.99|6.64|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C on Day 29.||6.64|-3.99|
71015370|NCT03433482|141538201|OTHER||Difference in percentage of subjects|4.09|||||TWO_SIDED|95.0|-1.11|9.33|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 the N. meningitidis serogroup W on Day 29.||9.33|-1.11|
71015371|NCT03433482|141538201|OTHER||Difference in percentage of subjects|0.48|||||TWO_SIDED|95.0|-4.16|5.13|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y on Day 29.||5.13|-4.16|
71049575|NCT02504671|141606189|OTHER||Difference|51.4|||||TWO_SIDED|95.0|34.5|68.2|||||Week 32, ACR20. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||68.2|34.5|
71104636|NCT01098747|141716669|SUPERIORITY_OR_OTHER||LS mean difference|0.93|||<|0.001|TWO_SIDED|95.0|0.61|1.26||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.26|0.61|<0.001
71104637|NCT01098747|141716669|SUPERIORITY_OR_OTHER||LS mean difference|-0.22||||0.064|TWO_SIDED|95.0|-0.46|0.01||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.01|-0.46|0.064
70930066|NCT05652010|141357949|OTHER||Binominal|0.9|||<|0.0001|TWO_SIDED|95.0|0.75|0.97|||Exact test in the binomial distribution|Exact test in the binomial distribution tested if the proportion of very satisfied/satisfied was sign. different from 50% when using a 5% test level|The binomial proportion is based on subjects that have answered the questions. Exact test in the binomial distribution.|||0.97|0.75|<0.0001
71015372|NCT03433482|141538202|OTHER||Difference in percentage of subjects|1.29|||||TWO_SIDED|95.0|-3.37|5.99|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 1||5.99|-3.37|
71015373|NCT03433482|141538202|OTHER||Difference in percentage of subjects|7.23|||||TWO_SIDED|95.0|0.25|14.13|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 1||14.13|0.25|
71015374|NCT03433482|141538202|OTHER||Difference in percentage of subjects|3.92|||||TWO_SIDED|95.0|-2.57|10.39|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 1||10.39|-2.57|
71015375|NCT03433482|141538202|OTHER||Difference in percentage of subjects|1.49|||||TWO_SIDED|95.0|-4.44|7.44|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 1||7.44|-4.44|
71015376|NCT03433482|141538202|OTHER||Difference in percentage of subjects|1.73|||||TWO_SIDED|95.0|-1.94|5.46|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 29||5.46|-1.94|
71015377|NCT03433482|141538202|OTHER||Difference in percentage of subjects|-0.99|||||TWO_SIDED|95.0|-6.66|4.7|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 29||4.70|-6.66|
71015378|NCT03433482|141538202|OTHER||Difference in percentage of subjects|-1.43|||||TWO_SIDED|95.0|-7.05|4.18|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 29||4.18|-7.05|
71049576|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 32, ACR50. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049577|NCT02504671|141606189|OTHER||Difference|27.0|||||TWO_SIDED|95.0|11.4|42.7|||||Week 32, ACR50. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.7|11.4|
71015379|NCT03433482|141538202|OTHER||Difference in percentage of subjects|2.06|||||TWO_SIDED|95.0|-2.67|6.8|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 29||6.80|-2.67|
71015380|NCT03433482|141538202|OTHER||Difference in percentage of subjects|1.75|||||TWO_SIDED|95.0|-3.32|6.83|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 1||6.83|-3.32|
71015381|NCT03433482|141538202|OTHER||Difference in percentage of subjects|3.87|||||TWO_SIDED|95.0|-3.0|10.71|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 1||10.71|-3.00|
71015382|NCT03433482|141538202|OTHER||Difference in percentage of subjects|-0.73|||||TWO_SIDED|95.0|-7.24|5.77|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 1||5.77|-7.24|
71015383|NCT03433482|141538202|OTHER||Difference in percentage of subjects|-1.12|||||TWO_SIDED|95.0|-6.99|4.75|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 1||4.75|-6.99|
71015384|NCT03433482|141538202|OTHER||Difference in percentage of subjects|-0.64|||||TWO_SIDED|95.0|-4.24|2.96|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 29||2.96|-4.24|
71015385|NCT03433482|141538202|OTHER||Difference in percentage of subjects|0.0|||||TWO_SIDED|95.0|-5.16|5.16|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 29||5.16|-5.16|
71015386|NCT03433482|141538202|OTHER||Difference in percentage of subjects|4.09|||||TWO_SIDED|95.0|-1.11|9.33|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 29||9.33|-1.11|
71104638|NCT01098747|141716669|SUPERIORITY_OR_OTHER||LS mean difference|0.85|||<|0.001|TWO_SIDED|95.0|0.52|1.18||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.18|0.52|<0.001
71015387|NCT03433482|141538202|OTHER||Difference in percentage of subjects|0.73|||||TWO_SIDED|95.0|-3.88|5.37|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 29||5.37|-3.88|
71015388|NCT01646268|141538208|SUPERIORITY_OR_OTHER||LS Means|-4.82|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|-7.18|-2.45|||ANCOVA||Value describes the difference value of the mean change from baseline between Rotigotine and Placebo groups. The Value for this outcome was -4.6.|The null hypothesis (H0) is that there is no difference in the change in the sum of the score from the ADL and motor examination in the UPDRS (Parts II+II) between the active treatment and the placebo groups (i.e., the change from Baseline in the sum of the score from the ADL and motor examination in the UPDRS (Parts II+III) is the same for both groups).||-2.45|-7.18|<0.0001
71015389|NCT00461591|141538218|SUPERIORITY||Odds Ratio (OR)|0.76||||0.1068|TWO_SIDED|95.0|0.54|1.06|||Cochran-Mantel-Haenszel|||||1.06|0.54|0.1068
71015390|NCT00461591|141538219|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0412|TWO_SIDED|95.0|0.59|0.99|||Log Rank|||||0.99|0.59|0.0412
71015391|NCT02325414|141538239|SUPERIORITY||Median Difference (Final Values)|10.61||||0.05|TWO_SIDED||||||Mixed Models Analysis||||One-year data analysis were carried out using linear mixed-effects models. Covariate adjustments for baseline value of the corresponding outcome and ambulatory status (measured by WISCI) were performed by fitting these variables as fixed factors. The repeated measures were addressed using participant identification as random intercepts in the model.|||0.05
71015392|NCT02544607|141538243|OTHER||||||<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.01
71015393|NCT02544607|141538244|OTHER|||||||0.048|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.048
71015394|NCT02544607|141538245|OTHER|||||||0.003|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.003
71104639|NCT01098747|141716669|SUPERIORITY_OR_OTHER||LS mean difference|-0.22||||0.074|TWO_SIDED|95.0|-0.46|0.02||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.02|-0.46|0.074
70850640|NCT02712047|141189438|OTHER||Mean Difference (Net)|5.19|||||TWO_SIDED|95.0|-45.35|55.73|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 21, PM|||55.73|-45.35|
71015395|NCT02544607|141538246|OTHER|||||||0.0499|TWO_SIDED|95.0|||||t-test, 2 sided|||||||.0499
71015396|NCT02544607|141538247|OTHER|||||||0.038|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.038
71015397|NCT00347776|141538281|SUPERIORITY||Cox Proportional Hazard|0.67||||0.047|TWO_SIDED|95.0|0.45|0.98|||Log Rank|||"The log rank test was done to compare the survival rates between the tetracycline arm and the azithromycin arms combined.~The Cox proportional hazard model was used to evaluate risk factors and adjust for confounding in predicting recurrence."||0.98|0.45|.047
71015398|NCT00347776|141538282|SUPERIORITY|||||||0.19|||||||Log Rank|||"We tried to evaluate if treating the immediate family members of the subject with oral azithromycin along with the subject had added advantage in reducing the rate of recurrent trichiasis in comparison to treating the subject alone with oral azithromycin post surgery.~The log rank test was done to compare the survival rates between the two intervention arms.The comparison results were expressed in person-years."||||0.19
71015399|NCT00347776|141538283|SUPERIORITY||Odds Ratio (OR)|0.63|||||TWO_SIDED|95.0|0.36|1.1|||Regression, Logistic||Comparison group was the tetracycline group.|Surgery was considered a failure if there was trichiasis recurrence at 6 week follow-up.||1.10|0.36|
71015400|NCT00594568|141538285|SUPERIORITY_OR_OTHER|||||||0.134||95.0|||||Mixed Models Analysis|||||||0.134
71015401|NCT00594568|141538285|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||Mixed Models Analysis|||||||0.045
71015402|NCT00594568|141538285|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Mixed Models Analysis|||||||0.610
71015403|NCT00594568|141538286|SUPERIORITY_OR_OTHER|||||||0.296||95.0|||||Mixed Models Analysis|||||||0.296
71015404|NCT00594568|141538286|SUPERIORITY_OR_OTHER|||||||0.172||95.0|||||Mixed Models Analysis|||||||0.172
71015405|NCT00594568|141538286|SUPERIORITY_OR_OTHER|||||||0.746||95.0|||||Mixed Models Analysis|||||||0.746
71015406|NCT00594568|141538287|SUPERIORITY_OR_OTHER|||||||0.166||95.0|||||Mixed Models Analysis|||||||0.166
71015407|NCT00594568|141538287|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
71015408|NCT00594568|141538287|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Mixed Models Analysis|||||||0.014
71015409|NCT00594568|141538288|SUPERIORITY_OR_OTHER|||||||0.935||95.0|||||Mixed Models Analysis|||||||0.935
71015410|NCT00594568|141538288|SUPERIORITY_OR_OTHER|||||||0.068||95.0|||||Mixed Models Analysis|||||||0.068
71015411|NCT00594568|141538288|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Mixed Models Analysis|||||||0.070
71015412|NCT00594568|141538289|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||||||0.002
71015413|NCT00594568|141538289|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71015414|NCT00594568|141538289|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71015415|NCT00594568|141538290|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||ANCOVA|||||||0.038
71015416|NCT00594568|141538290|SUPERIORITY_OR_OTHER|||||||0.147||95.0|||||ANCOVA|||||||0.147
71015417|NCT00594568|141538290|SUPERIORITY_OR_OTHER|||||||0.604||95.0|||||ANCOVA|||||||0.604
71049578|NCT02504671|141606189|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 32, ACR70. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
70850641|NCT02712047|141189439|OTHER||Mean Difference (Net)|0.36|||||TWO_SIDED|95.0|0.26|0.46|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 1, AM|||0.46|0.26|
71015418|NCT00594568|141538291|SUPERIORITY_OR_OTHER|||||||0.143||95.0||||This is the p-value for the Left Hippocampal Volume|ANCOVA|||||||0.143
71015419|NCT00594568|141538291|SUPERIORITY_OR_OTHER|||||||0.464||95.0||||This is the p-value for the Left Hippocampal Volume|ANCOVA|||||||0.464
71015420|NCT00594568|141538291|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||This is the p-value for the Left Hippocampal Volume|ANCOVA|||||||0.025
71015421|NCT00594568|141538291|SUPERIORITY_OR_OTHER|||||||0.347||95.0||||This is the p-value for the Right Hippocampal Volume|ANCOVA|||||||0.347
71015422|NCT00594568|141538291|SUPERIORITY_OR_OTHER|||||||0.82||95.0||||This is the p-value for the Right Hippocampal Volume|ANCOVA|||||||0.820
71015423|NCT00594568|141538291|SUPERIORITY_OR_OTHER|||||||0.243||95.0||||This is the p-value for the Right Hippocampal Volume|ANCOVA|||||||0.243
71015424|NCT00594568|141538292|SUPERIORITY_OR_OTHER|||||||0.784||95.0|||||ANCOVA|||||||0.784
71015425|NCT00594568|141538292|SUPERIORITY_OR_OTHER|||||||0.931||95.0|||||ANCOVA|||||||0.931
71015426|NCT00594568|141538292|SUPERIORITY_OR_OTHER|||||||0.718||95.0|||||ANCOVA|||||||0.718
71015427|NCT00594568|141538293|SUPERIORITY_OR_OTHER|||||||0.634||95.0|||||ANCOVA|||||||0.634
71015428|NCT00594568|141538293|SUPERIORITY_OR_OTHER|||||||0.901||95.0|||||ANCOVA|||||||0.901
71015429|NCT00594568|141538293|SUPERIORITY_OR_OTHER|||||||0.659||95.0|||||ANCOVA|||||||0.659
71015430|NCT00594568|141538296|SUPERIORITY_OR_OTHER|||||||0.062||95.0|||||Mixed Models Analysis|||||||0.062
71015431|NCT00594568|141538296|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Mixed Models Analysis|||||||0.022
71015432|NCT00594568|141538296|SUPERIORITY_OR_OTHER|||||||0.669||95.0|||||Mixed Models Analysis|||||||0.669
71015433|NCT00594568|141538297|SUPERIORITY_OR_OTHER|||||||0.071||95.0|||||Mixed Models Analysis|||||||0.071
71015434|NCT00594568|141538297|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||Mixed Models Analysis|||||||0.018
71015435|NCT00594568|141538297|SUPERIORITY_OR_OTHER|||||||0.571||95.0|||||Mixed Models Analysis|||||||0.571
71015436|NCT00594568|141538298|SUPERIORITY_OR_OTHER|||||||0.518||95.0|||||Mixed Models Analysis|||||||0.518
71015437|NCT00594568|141538298|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||Mixed Models Analysis|||||||0.013
71015438|NCT00594568|141538298|SUPERIORITY_OR_OTHER|||||||0.072||95.0|||||Mixed Models Analysis|||||||0.072
71015439|NCT00594568|141538299|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||Mixed Models Analysis|||||||0.069
71015440|NCT00594568|141538299|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mixed Models Analysis|||||||0.002
71015441|NCT00594568|141538299|SUPERIORITY_OR_OTHER|||||||0.198||95.0|||||Mixed Models Analysis|||||||0.198
71015442|NCT00594568|141538300|SUPERIORITY_OR_OTHER|||||||0.127||95.0|||||Mixed Models Analysis|||||||0.127
71015443|NCT00594568|141538300|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||Mixed Models Analysis|||||||0.016
71015444|NCT00594568|141538300|SUPERIORITY_OR_OTHER|||||||0.381||95.0|||||Mixed Models Analysis|||||||0.381
71015445|NCT00594568|141538301|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
71015446|NCT00594568|141538301|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Mixed Models Analysis|||||||0.005
71015447|NCT00594568|141538301|SUPERIORITY_OR_OTHER|||||||0.141||95.0|||||Mixed Models Analysis|||||||0.141
71015448|NCT00594568|141538302|SUPERIORITY_OR_OTHER|||||||0.337||95.0|||||ANCOVA|||||||0.337
71015449|NCT00594568|141538302|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||ANCOVA|||||||0.018
71015450|NCT00594568|141538302|SUPERIORITY_OR_OTHER|||||||0.157||95.0|||||ANCOVA|||||||0.157
71015451|NCT00594568|141538303|SUPERIORITY_OR_OTHER|||||||0.186||95.0|||||Mixed Models Analysis|||||||0.186
71015452|NCT00594568|141538303|SUPERIORITY_OR_OTHER|||||||0.149||95.0|||||Mixed Models Analysis|||||||0.149
71015453|NCT00594568|141538303|SUPERIORITY_OR_OTHER|||||||0.889||95.0|||||Mixed Models Analysis|||||||0.889
71015454|NCT00594568|141538304|SUPERIORITY_OR_OTHER|||||||0.202||95.0|||||Mixed Models Analysis|||||||0.202
71015455|NCT00594568|141538304|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||Mixed Models Analysis|||||||0.075
71015456|NCT00594568|141538304|SUPERIORITY_OR_OTHER|||||||0.616||95.0|||||Mixed Models Analysis|||||||0.616
71049579|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 32, ACR70. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049580|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 36, ACR20. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
70930067|NCT05652010|141357950|OTHER|The binomial proportion is based on subjects that have answered the questions. Exact test in the binomial distribution.|Binominal|0.82|||<|0.0001|TWO_SIDED|95.0|0.66|0.92|||Exact test in the binominal distribution|Exact test in the binomial distribution tested if the proportion of YES was significantly different from 50% when using a 5% test level||||0.92|0.66|<0.0001
71015457|NCT00518531|141538325|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|10.5||||0.0259|TWO_SIDED|95.0|1.3|19.7||All statistical hypothesis tests were conducted at the 0.05 significance level. No adjustment was employed for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture|Positive values for absolute risk reduction favor denosumab.|||19.7|1.3|0.0259
71049581|NCT02504671|141606189|OTHER||Difference|56.8|||||TWO_SIDED|95.0|40.1|73.4|||||Week 36, ACR20. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||73.4|40.1|
71049582|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 36, ACR50. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049583|NCT02504671|141606189|OTHER||Difference|32.4|||||TWO_SIDED|95.0|16.2|48.7|||||Week 36, ACR50. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.7|16.2|
71049584|NCT02504671|141606189|OTHER||Difference|16.2|||||TWO_SIDED|95.0|4.3|28.1|||||Week 36, ACR70. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|4.3|
71049585|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 36, ACR70. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71049586|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 40, ACR20. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049587|NCT02504671|141606189|OTHER||Difference|51.4|||||TWO_SIDED|95.0|34.5|68.2|||||Week 40, ACR20. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||68.2|34.5|
71015458|NCT00518531|141538326|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|30.9|||<|0.0001|TWO_SIDED|95.0|20.6|41.3||All statistical hypothesis tests were conducted at the 0.05 significance level. No adjustment was employed for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture|Positive values for absolute risk reduction favor denosumab.|||41.3|20.6|<0.0001
71049588|NCT02504671|141606189|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 40, ACR50. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71049589|NCT02504671|141606189|OTHER||Difference|29.7|||||TWO_SIDED|95.0|13.8|45.7|||||Week 40, ACR50. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||45.7|13.8|
71049590|NCT02504671|141606189|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 40, ACR70. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
71049591|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 40, ACR70. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049592|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 44, ACR20. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049593|NCT02504671|141606189|OTHER||Difference|51.4|||||TWO_SIDED|95.0|34.5|68.2|||||Week 44, ACR20. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||68.2|34.5|
71049594|NCT02504671|141606189|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 44, ACR50. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71049595|NCT02504671|141606189|OTHER||Difference|35.1|||||TWO_SIDED|95.0|18.7|51.6|||||Week 44, ACR50. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||51.6|18.7|
71049596|NCT02504671|141606189|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 44, ACR70. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71049597|NCT02504671|141606189|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 44, ACR70. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
71049598|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 48, ACR20. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049599|NCT02504671|141606189|OTHER||Difference|51.4|||||TWO_SIDED|95.0|37.3|70.9|||||Week 48, ACR20. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||70.9|37.3|
71049600|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 48, ACR50. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049601|NCT02504671|141606189|OTHER||Difference|32.4|||||TWO_SIDED|95.0|16.2|48.7|||||Week 48, ACR50. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.7|16.2|
71049602|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 48, ACR70. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71049603|NCT02504671|141606189|OTHER||Difference|21.6|||||TWO_SIDED|95.0|8.4|34.9|||||Week 48, ACR70. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||34.9|8.4|
70930068|NCT05652010|141357951|OTHER||Odds Ratio (OR)|0.259||||0.027|TWO_SIDED|95.0|0.078|0.855||P=0.027 for testing the hypothesis that OR=1|Mixed Models Analysis|Generalized linear mixed model|P=0.027 for testing the hypothesis that OR=1|||0.855|0.078|0.027
70850642|NCT02712047|141189439|OTHER||Mean Difference (Net)|0.26|||||TWO_SIDED|95.0|0.16|0.36|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 1, PM|||0.36|0.16|
71015459|NCT00518531|141538327|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.0||||0.0138|TWO_SIDED|95.0|2.2|19.7|||Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture.|Positive values for absolute risk reduction favor denosumab.|||19.7|2.2|0.0138
71015460|NCT00518531|141538328|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|27.7|||<|0.0001|TWO_SIDED|95.0|17.6|37.7|||Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture.|Positive values for absolute risk reduction favor denosumab.|||37.7|17.6|<0.0001
71015461|NCT00518531|141538329|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|9.8||||0.0291|TWO_SIDED|95.0|1.1|18.5|||Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture.|Positive values for absolute risk reduction favor denosumab.|||18.5|1.1|0.0291
71015462|NCT00518531|141538330|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|27.4|||<|0.0001|TWO_SIDED|95.0|18.1|36.7|||Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture.|Positive values for absolute risk reduction favor denosumab.|||36.7|18.1|<0.0001
71015463|NCT01656850|141538343|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
71015464|NCT01656850|141538344|SUPERIORITY_OR_OTHER|||||||0.2786|TWO_SIDED||||||Mixed Models Analysis|||||||0.2786
71015465|NCT01656850|141538345|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED||||||Mixed Models Analysis|||||||0.420
71015466|NCT01656850|141538346|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
71015467|NCT01656850|141538347|SUPERIORITY_OR_OTHER|||||||0.2412|TWO_SIDED||||||Mixed Models Analysis|||||||0.2412
71015468|NCT01656850|141538348|SUPERIORITY_OR_OTHER|||||||0.3837|TWO_SIDED||||||Mixed Models Analysis|||||||0.3837
71015469|NCT01656850|141538349|SUPERIORITY_OR_OTHER|||||||0.9784|TWO_SIDED||||||Mixed Models Analysis|||||||0.9784
71015470|NCT01656850|141538350|SUPERIORITY_OR_OTHER|||||||0.5868|TWO_SIDED||||||Mixed Models Analysis|||||||0.5868
71015471|NCT01656850|141538351|SUPERIORITY_OR_OTHER|||||||0.1101|TWO_SIDED||||||Mixed Models Analysis|||||||0.1101
71015472|NCT01656850|141538352|SUPERIORITY_OR_OTHER|||||||0.7823|TWO_SIDED||||||Mixed Models Analysis|||||||0.7823
71015473|NCT01656850|141538353|SUPERIORITY_OR_OTHER|||||||0.557|TWO_SIDED||||||Mixed Models Analysis|||||||0.5570
71015474|NCT01656850|141538354|SUPERIORITY_OR_OTHER|||||||0.6263|TWO_SIDED||||||Mixed Models Analysis|||||||0.6263
71015475|NCT01656850|141538355|SUPERIORITY_OR_OTHER|||||||0.8328|TWO_SIDED||||||Mixed Models Analysis|||||||0.8328
71015476|NCT01656850|141538356|SUPERIORITY_OR_OTHER|||||||0.7758|TWO_SIDED||||||Mixed Models Analysis|||||||0.7758
71015477|NCT01656850|141538357|SUPERIORITY_OR_OTHER|||||||0.0476|TWO_SIDED||||||Mixed Models Analysis|||||||0.0476
71015478|NCT01656850|141538358|SUPERIORITY_OR_OTHER|||||||0.1205|TWO_SIDED||||||Mixed Models Analysis|||||||0.1205
71015479|NCT01656850|141538359|SUPERIORITY_OR_OTHER|||||||0.1512|TWO_SIDED||||||Mixed Models Analysis|||||||0.1512
71015480|NCT01656850|141538360|SUPERIORITY_OR_OTHER|||||||0.7364|TWO_SIDED||||||Mixed Models Analysis|||||||0.7364
71015481|NCT01656850|141538361|SUPERIORITY_OR_OTHER|||||||0.1995|TWO_SIDED||||||Mixed Models Analysis|||||||0.1995
71015482|NCT01656850|141538362|SUPERIORITY_OR_OTHER|||||||0.8528|TWO_SIDED||||||Mixed Models Analysis|||||||0.8528
71015483|NCT00296192|141538367|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9|STANDARD_ERROR_OF_MEAN|2.91||||95.0|-2.9|8.7|||ANCOVA|||Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value.||8.7|-2.9|
71015484|NCT00296192|141538367|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|2.93||||95.0|-5.7|6.0|||ANCOVA|||Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value.||6.0|-5.7|
71015485|NCT00296192|141538367|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9|STANDARD_ERROR_OF_MEAN|2.86||||95.0|-2.8|8.6|||ANCOVA|||Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value.||8.6|-2.8|
71015486|NCT00296192|141538367|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|3.02||||95.0|-7.4|4.6|||ANCOVA|||Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value.||4.6|-7.4|
71015487|NCT00296192|141538368|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.6|STANDARD_ERROR_OF_MEAN|8.58||||95.0|-25.7|8.5|||ANCOVA|||Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.||8.5|-25.7|
71015488|NCT00296192|141538368|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.8|STANDARD_ERROR_OF_MEAN|8.63||||95.0|-34.0|0.4|||ANCOVA|||Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.||0.4|-34.0|
71015489|NCT00296192|141538368|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|8.45||||95.0|-18.2|15.4|||ANCOVA|||Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.||15.4|-18.2|
71015490|NCT00296192|141538368|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.5|STANDARD_ERROR_OF_MEAN|8.9||||95.0|-23.3|12.2|||ANCOVA|||Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.||12.2|-23.3|
71015491|NCT00296192|141538369|SUPERIORITY_OR_OTHER||Difference in proportions|-20.6||||||95.0|-53.3|12.1|||Confidence interval|||95% confidence interval in difference in success rate||12.1|-53.3|
71015492|NCT00296192|141538369|SUPERIORITY_OR_OTHER||Difference in proportions|4.4||||||95.0|-25.9|34.7|||95% confidence interval|||95% confidence interval in difference in success rate||34.7|-25.9|
71015493|NCT00296192|141538369|SUPERIORITY_OR_OTHER||Difference in proportions|0.0||||||95.0|-30.6|30.6|||95% confidence interval|||95% confidence interval in difference in success rate||30.6|-30.6|
71015494|NCT00296192|141538369|SUPERIORITY_OR_OTHER||Difference in proportions|4.4||||||95.0|-25.9|34.7|||95% confidence interval|||95% confidence interval in difference in success rate||34.7|-25.9|
71015495|NCT03681769|141538396|EQUIVALENCE|Non-equivalence determined by p\<.05.||||||0.83||||||No site X time interaction (F12,270 = 0.614, p = 0.830).|Mixed Models Analysis|||||||.83
71015496|NCT03681769|141538397|OTHER|||||||0.53|||||||t-test, 2 sided|||||||.53
71015497|NCT03722849|141538433|OTHER||||||=|0.0028||||||No multiple comparisons as region of interest analysis defined a priori.|Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests for non-parametric data||||=0.0028
71049604|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 52, ACR20. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049605|NCT02504671|141606189|OTHER||Difference|48.6|||||TWO_SIDED|95.0|31.7|65.6|||||Week 52, ACR20. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||65.6|31.7|
71049606|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 52, ACR50. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049607|NCT02504671|141606189|OTHER||Difference|24.3|||||TWO_SIDED|95.0|9.1|39.6|||||Week 52, ACR50. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||39.6|9.1|
71104640|NCT01098747|141716670|SUPERIORITY_OR_OTHER||LS mean difference|0.65||||0.001|TWO_SIDED|95.0|0.26|1.04||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.04|0.26|0.001
71104641|NCT01098747|141716670|SUPERIORITY_OR_OTHER||LS mean difference|0.46||||0.001|TWO_SIDED|95.0|0.18|0.75||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.75|0.18|0.001
71015498|NCT03722849|141538434|OTHER||||||=|0.007||||||No multiple comparisons as region of interest analysis defined a priori.|Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests for non-parametric data||||=0.0070
71015499|NCT03722849|141538435|OTHER|Group comparisons (Cough versus healthy) for each measurement using repeated measures ANOVA.|||||=|0.0019|||||||ANOVA|with repeated measures||||||=0.0019
71015500|NCT03722849|141538437|OTHER|Group-wise comparisons using unpaired t-tests or one way ANOVA|||||<|0.0001|||||||ANOVA|||||||<0.0001
71015501|NCT02354352|141538438|NON_INFERIORITY|Using a Type I error rate of 5%, we conducted a power calculation using a non-inferiority test on 12-month change in Ecc. If there is truly no difference in the 12-month Ecc change between the spironolactone and eplerenone groups, 46 patients (23 in each group) would result in at least 80% power to ensure that the lower limit of a one-sided 95% confidence interval for the true difference between the spironolactone and eplerenone groups to be above the non-inferiority limit of -1.75.||||||0.5867|||||||Wilcoxon (Mann-Whitney)|||||||0.5867
71015502|NCT04633434|141538439|EQUIVALENCE|Test of whether the pretest and posttest scores are significantly different from zero.|Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.56||0.69|TWO_SIDED||||||t-test, 2 sided||Estimation parameter based on paired t-test.|||||.690
71015503|NCT04633434|141538440|EQUIVALENCE|Test of whether pretest to posttest score change is greater than zero.|Mean Difference (Final Values)|0.647|STANDARD_ERROR_OF_MEAN|0.308||0.052|TWO_SIDED||||||t-test, 2 sided|||||||.052
71015504|NCT04633434|141538441|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|0.647|STANDARD_ERROR_OF_MEAN|0.41||0.135|TWO_SIDED||||||t-test, 2 sided|||||||.135
71015505|NCT04633434|141538442|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|4.24|STANDARD_ERROR_OF_MEAN|7.14||0.026|TWO_SIDED||||||t-test, 2 sided|||||||.026
71049608|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 52, ACR70. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71049609|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 52, ACR70. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71049610|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 62 (follow-up), ACR20. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049611|NCT02504671|141606189|OTHER||Difference|40.5|||||TWO_SIDED|95.0|23.7|57.3|||||Week 62 (follow-up), ACR20. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||57.3|23.7|
71049612|NCT02504671|141606189|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 62 (follow-up), ACR50. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71049613|NCT02504671|141606189|OTHER||Difference|24.3|||||TWO_SIDED|95.0|9.1|39.6|||||Week 62 (follow-up), ACR50. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||39.6|9.1|
71049614|NCT02504671|141606189|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 62 (follow-up), ACR70. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71049615|NCT02504671|141606189|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 62 (follow-up), ACR70. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71104642|NCT01098747|141716670|SUPERIORITY_OR_OTHER||LS mean difference|2.41|||<|0.001|TWO_SIDED|95.0|1.82|3.01||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.01|1.82|<0.001
70930069|NCT02518048|141357961|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.17|||<|0.001|TWO_SIDED|95.0|-2.58|-1.76||Least Square Means difference from ANOVA with treatment group as fixed effect and subject as random effect (105 treated sites per treatment group).|ANOVA|||A last observation carried forward (LOCF) approach was used to account for drop-outs and missing values in the analysis of end of treatment values.||-1.76|-2.58|<0.001
71015506|NCT04633434|141538443|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
71049616|NCT02504671|141606190|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 4. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049617|NCT02504671|141606190|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049618|NCT02504671|141606190|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Index based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
71015507|NCT04633434|141538444|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
71015508|NCT04633434|141538445|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|-1.11|STANDARD_ERROR_OF_MEAN|0.54||0.057|TWO_SIDED||||||t-test, 2 sided|||||||.057
71015509|NCT04633434|141538446|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|1.89|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
71015510|NCT04633434|141538447|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.1||0.352|TWO_SIDED||||||t-test, 2 sided|||||||.352
71015511|NCT04633434|141538448|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.13||0.104|TWO_SIDED||||||t-test, 2 sided|||||||.104
71015512|NCT04633434|141538451|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.19||0.106|TWO_SIDED||||||t-test, 2 sided|||||||.106
71015513|NCT04633434|141538452|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.19||0.005|TWO_SIDED||||||t-test, 2 sided|||||||.005
71015514|NCT04633434|141538453|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|3.52|STANDARD_ERROR_OF_MEAN|1.9||0.082|TWO_SIDED||||||t-test, 2 sided|||||||.082
71015515|NCT04259905|141538488|SUPERIORITY||Cohen's d|0.85|||||TWO_SIDED|||||||||||||
71015516|NCT04259905|141538489|SUPERIORITY||Cohen's d|1.29|||||TWO_SIDED|||||||||||||
71015517|NCT04259905|141538490|SUPERIORITY||Cohen's d|1.06|||||TWO_SIDED|||||||||||||
71015518|NCT05014672|141538536|SUPERIORITY||Ratio of geometric LS mean vs placebo|0.86||||0.0206|TWO_SIDED|95.0|0.746|0.994|||Mixed Model Repeated Measures|||||0.994|0.746|0.0206
71015519|NCT05014672|141538536|SUPERIORITY||Ratio of geometric LS mean vs placebo|0.81||||0.0057|TWO_SIDED|95.0|0.703|0.939|||Mixed Model Repeated Measures|||||0.939|0.703|0.0057
71015520|NCT05014672|141538537|SUPERIORITY||LS mean difference vs placebo|-2.16||||0.2214|TWO_SIDED|95.0|-7.785|3.458|||Mixed Model Repeated Measures|||||3.458|-7.785|0.2214
71015521|NCT05014672|141538537|SUPERIORITY||LS mean difference vs placebo|0.63||||0.591|TWO_SIDED|95.0|-4.859|6.12|||Mixed Model Repeated Measures|||||6.120|-4.859|0.5910
71015522|NCT05014672|141538540|SUPERIORITY||LS mean difference vs placebo|0.42||||0.5675|TWO_SIDED|95.0|-4.454|5.285|||Mixed Model Repeated Measures|||||5.285|-4.454|0.5675
71015523|NCT05014672|141538540|SUPERIORITY||LS mean difference vs placebo|0.02||||0.5032|TWO_SIDED|95.0|-4.886|4.926|||Mixed Model Repeated Measures|||||4.926|-4.886|0.5032
71015524|NCT05014672|141538541|SUPERIORITY||Ratio of geometric LS mean vs placebo|0.85||||0.0491|TWO_SIDED|95.0|0.692|1.033|||Mixed Model Repeated Measures|||||1.033|0.692|0.0491
71015525|NCT05014672|141538541|SUPERIORITY||Ratio of geometric LS mean vs placebo|0.95||||0.3099|TWO_SIDED|95.0|0.783|1.158|||Mixed Model Repeated Measures|||||1.158|0.783|0.3099
71015526|NCT05014672|141538547|SUPERIORITY||Ratio of geometric LS mean vs placebo|0.84||||0.0039|TWO_SIDED|95.0|0.743|0.954|||Mixed Model Repeated Measures|||||0.954|0.743|0.0039
71015527|NCT05014672|141538548|SUPERIORITY||LS mean difference vs placebo|0.3905||||0.3905|TWO_SIDED|95.0|-5.496|4.153|||Mixed Model Repeated Measures|||||4.153|-5.496|0.3905
71049619|NCT02504671|141606190|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Index based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
71049620|NCT02504671|141606190|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
71049621|NCT02504671|141606190|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Index based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
71049622|NCT02504671|141606190|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Index based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
71049623|NCT02504671|141606190|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
71104643|NCT01098747|141716670|SUPERIORITY_OR_OTHER||LS mean difference|0.91|||<|0.001|TWO_SIDED|95.0|0.48|1.34||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.34|0.48|<0.001
71104644|NCT01098747|141716670|SUPERIORITY_OR_OTHER||LS mean difference|3.68|||<|0.001|TWO_SIDED|95.0|3.03|4.33||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.33|3.03|<0.001
71104645|NCT01098747|141716670|SUPERIORITY_OR_OTHER||LS mean difference|0.64||||0.008|TWO_SIDED|95.0|0.17|1.11||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.11|0.17|0.008
70930070|NCT02518048|141357964|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.53|-0.32||Least Square Means difference from ANOVA with treatment group as fixed effect and subject as random effect (105 treated sites per treatment group)|ANOVA|||Total Skin Thickness: LEO 90100 vs. Betesil®||-0.32|-0.53|<0.001
71104646|NCT01098747|141716670|SUPERIORITY_OR_OTHER||LS mean difference|4.06|||<|0.001|TWO_SIDED|95.0|3.4|4.72||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.72|3.40|<0.001
70930071|NCT02518048|141357964|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|||<|0.001|TWO_SIDED|95.0|-0.69|-0.41||Least Square Means difference from ANOVA with treatment group as fixed effect and subject as random effect (105 treated sites per treatment group)|ANOVA|||Echo-Poor Band Thickness: LEO 90100 vs. Betesil®||-0.41|-0.69|<0.001
70930072|NCT02278211|141358044|OTHER||Hazard Ratio (HR)|1.25||||0.2|TWO_SIDED|95.0|0.89|1.76|||Log Rank|||||1.76|0.89|0.20
70930073|NCT02278211|141358045|OTHER||Hazard Ratio (HR)|2.43||||0.02|TWO_SIDED|95.0|1.15|5.12|||Log Rank|||||5.12|1.15|0.02
71104647|NCT01098747|141716670|SUPERIORITY_OR_OTHER||LS mean difference|0.58||||0.017|TWO_SIDED|95.0|0.1|1.06||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.06|0.10|0.017
70930074|NCT04778410|141358053|SUPERIORITY|||||||0.1794|||||||One Group Chi-Square test|The p-value was based on one group Chi-Square test for the null hypothesis CR rate was 0.19 at one-sided alpha of 0.1 in Cohort 2.||||||0.1794
70930075|NCT02905331|141358077|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
70930076|NCT02905331|141358078|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
70930077|NCT02905331|141358083|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70930078|NCT01385202|141358087|SUPERIORITY_OR_OTHER_LEGACY||Primary effectiveness rate|70.2|||<|0.0001|TWO_SIDED|95.0|60.9|78.4||In the worst-case scenario analysis, over seventy-percent (70.2%, 80/114) of the primary effectiveness cohort (PEC) were free from documented symptomatic atrial tachyarrhythmias during their effectiveness evaluation period.|Fisher Exact|The lower bound of the 95% confidence intervals was 60.9%, significantly higher than the pre-determined performance goal of 50% (p\<0.0001).|The confidence intervals above are the 95% exact binomial confidence intervals.|The null hypothesis was that the rate of freedom from documented symptomatic AF/AFL/AT at 12 months would be less than or equal to the pre-determined performance criterion of 50%. The alternative hypothesis was that the rate of freedom from documented symptomatic AF/AFL/AT at 12 months would be greater than the pre-determined performance criterion of 50%.||78.4|60.9|<0.0001
70930079|NCT01385202|141358087|SUPERIORITY_OR_OTHER_LEGACY||Primary effectiveness rate|74.0|||||TWO_SIDED|95.0|66.0|82.0|||||The 95% confidence intervals above were calculated using the Kaplan-Meier (KM) method.|||82|66|
71049624|NCT02504671|141606190|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049625|NCT02504671|141606190|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71015528|NCT05014672|141538549|SUPERIORITY||LS mean difference vs placebo|0.21||||0.5393|TWO_SIDED|95.0|-3.968|4.381|||Mixed Model Repeated Measures|||||4.381|-3.968|0.5393
71015529|NCT05014672|141538550|SUPERIORITY||Ratio of geometric LS mean vs placebo|0.9||||0.1079|TWO_SIDED|95.0|0.759|1.065|||Mixed Model Repeated Measures|||||1.065|0.759|0.1079
71104648|NCT01098747|141716670|SUPERIORITY_OR_OTHER||LS mean difference|4.09|||<|0.001|TWO_SIDED|95.0|3.42|4.75||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.75|3.42|<0.001
70850643|NCT02712047|141189439|OTHER||Mean Difference (Net)|0.34|||||TWO_SIDED|95.0|0.24|0.44|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 2, AM|||0.44|0.24|
70930080|NCT04102111|141358098|OTHER||Least Squares Means|37.4||||0.288|TWO_SIDED|90.0|-21.0|95.8|||Mixed Model for Repeated Measures (MMRM)|||||95.8|-21.0|0.288
70930081|NCT03663205|141358159|SUPERIORITY||Hazard Ratio (HR)|0.651||||0.0054|TWO_SIDED|95.0|0.465|0.912|||One-sided, Log Rank Test||Stratified by stratification factors: disease stage (IIIB or IV) and the level of PD-L1 expression in tumor cells (\>=50%, 1% to 49%, \<1%)|||0.912|0.465|0.0054
70930082|NCT03663205|141358166|OTHER||Least squares mean difference|-2.2|||||TWO_SIDED|95.0|-7.4|3.1|||||Based on a constrained longitudinal data analysis model with QLQ-LC13 coughing score on the response variable and treatment by study visit interaction and randomization stratification factors as covariates.|Least squares mean difference in coughing score||3.1|-7.4|
70930083|NCT03663205|141358166|OTHER||Least squares mean difference|-1.2|||||TWO_SIDED|95.0|-4.4|2.1|||||Based on a constrained longitudinal data analysis model with QLQ-LC13 dyspnea score on the response variable and treatment by study visit interaction and randomization stratification factors as covariates.|Least squares mean difference in dyspnea score||2.1|-4.4|
70930084|NCT03663205|141358166|OTHER||Least squares mean difference|-3.2|||||TWO_SIDED|95.0|-7.6|1.2|||||Based on a constrained longitudinal data analysis model with QLQ-LC13 chest pain score on the response variable and treatment by study visit interaction and randomization stratification factors as covariates.|Least squares mean difference in chest pain score||1.2|-7.6|
71015530|NCT00965562|141538551|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||Chi-squared|||||||0.15
71015531|NCT00965562|141538552|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||||||0.05
71015532|NCT00965562|141538553|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
71015533|NCT00965562|141538554|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Chi-squared|||||||0.09
71015534|NCT00965562|141538555|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Chi-squared|||||||0.005
71015535|NCT00965562|141538556|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Chi-squared|||||||0.04
71015536|NCT00965562|141538557|SUPERIORITY_OR_OTHER||Slope|-2.63||||0.07|TWO_SIDED|95.0|-5.51|0.24|||Mixed Models Analysis||Slope represents average change in fluoxetine group IDS score as compared to placebo|||0.24|-5.51|0.07
71015537|NCT00965562|141538557|SUPERIORITY_OR_OTHER||Slope|-0.1||||0.94|TWO_SIDED|95.0|-2.85|2.65|||Mixed Models Analysis||Slope represents average change in calcium group IDS scores as compared to placebo|||2.65|-2.85|0.94
71015538|NCT00965562|141538557|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.15||||0.07|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the fluoxetine group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.07
71049626|NCT02504671|141606190|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049627|NCT02504671|141606190|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71049628|NCT02504671|141606190|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049629|NCT02504671|141606190|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
70850644|NCT02712047|141189439|OTHER||Mean Difference (Net)|0.24|||||TWO_SIDED|95.0|0.14|0.34|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 2, PM|||0.34|0.14|
70930085|NCT03663205|141358167|OTHER||Least squares mean difference|3.9|||||TWO_SIDED|95.0|-0.9|8.7|||||Based on a constrained longitudinal data analysis model with QLQ-LC30 Global Health Status/Quality of Life score on the response variable and treatment by study visit interaction and randomization stratification factors as covariates.|Least squares mean difference in Global Health Status/Quality of Life score||8.7|-0.9|
70930086|NCT02326974|141358170|SUPERIORITY||||||<|0.001|||||||Mantel Haenszel|||By estimating that the overall pCR with T-DM1 plus pertuzumab would be approximately 40%, and 20% of the population classified as heterogeneous, the study would have 80% power with 136 evaluable patients to detect a difference in pCR of 44.9% in the non-heterogenous versus 20.3% in the heterogenous subgroup. The study had a 90% power to detect difference in pCR of 43.4% in the non-heterogenous versus 8.8% in the heterogenous subgroup if the observed prevalence of HER2 heterogeneity was 10%.||||<0.001
70930087|NCT02577354|141358179|SUPERIORITY|||||||0.138||||||The threshold for statistical significance was p=0.05|Wald asymptotic test of proportions|Cui p-value adjustment for sample size re-estimation at interim analysis; Multiple imputation utilized for 3 participants lost to follow-up.||||||0.138
70930088|NCT02577354|141358180|SUPERIORITY|||||||0.032||||||Threshold for statistical significance was p=0.05|t-test, 2 sided|||||||0.032
71015539|NCT00965562|141538557|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.1||||0.94|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the calcium group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.94
71049630|NCT02504671|141606190|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049631|NCT02504671|141606190|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71049632|NCT02504671|141606190|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71104649|NCT01098747|141716670|SUPERIORITY_OR_OTHER||LS mean difference|0.22||||0.359|TWO_SIDED|95.0|-0.26|0.7||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.70|-0.26|0.359
71104650|NCT01098747|141716670|SUPERIORITY_OR_OTHER||LS mean difference|3.75|||<|0.001|TWO_SIDED|95.0|3.06|4.45||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.45|3.06|<0.001
70850645|NCT02712047|141189439|OTHER||Mean Difference (Net)|0.26|||||TWO_SIDED|95.0|0.16|0.36|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 3, AM|||0.36|0.16|
70850646|NCT02712047|141189439|OTHER||Mean Difference (Net)|0.18|||||TWO_SIDED|95.0|0.08|0.28|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 3, PM|||0.28|0.08|
70930089|NCT02577354|141358181|SUPERIORITY|||||||0.0499||||||The threshold for significance was p=0.05.|Friedman's regression analysis|Multiple Imputation utilized for 3 participants lost to follow-up.||||||0.0499
70930090|NCT02577354|141358183|SUPERIORITY|||||||0.011||||||Threshold for statistical significance was p=0.05|t-test, 2 sided|||||||0.011
70930091|NCT02577354|141358184|SUPERIORITY|||||||0.009||||||Threshold for statistical significance was p=0.05|t-test, 2 sided|||||||0.009
70930092|NCT02577354|141358185|SUPERIORITY||||||<|0.001||||||Threshold for statistical significance was 0.05|t-test, 2 sided|||||||<0.001
71015540|NCT00965562|141538558|SUPERIORITY_OR_OTHER||Slope|-1.63||||0.1|TWO_SIDED|95.0|-3.6|0.34|||Mixed Models Analysis||Slope represents average change in fluoxetine group PMTS scores as compared to placebo|||0.34|-3.60|0.10
71015541|NCT00965562|141538558|SUPERIORITY_OR_OTHER||Slope|-0.81||||0.4|TWO_SIDED|95.0|-2.71|1.09|||Mixed Models Analysis||Slope represents average change in calcium group PMTS scores as compared to placebo|||1.09|-2.71|0.40
70930093|NCT02577354|141358186|SUPERIORITY|||||||0.003||||||Threshold for statistical significance was p=0.05.|Wilcoxon (Mann-Whitney)|||||||0.003
70930094|NCT02577354|141358187|SUPERIORITY|||||||0.335||||||Threshold for statistical significance was p=0.05.|Chi-squared|||||||0.335
71049633|NCT02504671|141606190|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71049634|NCT02504671|141606190|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049635|NCT02504671|141606190|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71049636|NCT02504671|141606190|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71049637|NCT02504671|141606190|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049638|NCT02504671|141606190|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71104651|NCT01098747|141716670|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.436|TWO_SIDED|95.0|-0.7|0.3||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.30|-0.70|0.436
70930095|NCT02577354|141358195|SUPERIORITY|||||||0.048||||||The threshold for statistical significance was p=0.05.|Wald asymptotic test of proportions|Multiple imputation used for three participants lost to follow-up.||||||0.048
70930096|NCT02577354|141358196|SUPERIORITY||||||<|0.001||||||"P-value for Satisfied with Treatment. Threshold for statistical significance was p=0.05"|Cochran-Mantel-Haenszel|||||||<0.001
70930097|NCT02577354|141358198|SUPERIORITY||||||<|0.001||||||Threshold for statistical significance was p=0.05.|Cochran-Mantel-Haenszel|||||||<0.001
70930098|NCT04424316|141358220|OTHER||Vaccine Efficacy|57.6|||||TWO_SIDED|95.0|31.3|74.6||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||74.6|31.3|
71015542|NCT00965562|141538558|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.06||||0.1|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the fluoxetine group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.10
71015543|NCT00965562|141538558|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.37||||0.4|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the calcium group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.40
71015544|NCT00965562|141538559|SUPERIORITY_OR_OTHER||Slope|-0.35||||0.07|TWO_SIDED|95.0|-0.73|0.03|||Mixed Models Analysis||Slope represents average change in fluoxetine group CGI-S scores as compared to placebo|||0.03|-0.73|0.07
71049639|NCT02504671|141606190|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71049640|NCT02504671|141606190|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
70930099|NCT04424316|141358221|OTHER||Vaccine Efficacy|54.5|||||TWO_SIDED|95.0|33.2|69.5||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||69.5|33.2|
70930100|NCT04424316|141358222|OTHER||Vaccine Efficacy|50.0|||||TWO_SIDED|95.0|30.3|64.5||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||64.5|30.3|
70930101|NCT04424316|141358223|OTHER||Vaccine Efficacy|49.2|||||TWO_SIDED|95.0|31.4|62.8||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||62.8|31.4|
70930102|NCT04424316|141358224|OTHER||Vaccine Efficacy|82.4|||||TWO_SIDED|95.0|57.5|93.9||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||93.9|57.5|
70930103|NCT04424316|141358225|OTHER||Vaccine Efficacy|73.5|||||TWO_SIDED|95.0|50.3|86.8||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||86.8|50.3|
70930104|NCT04424316|141358226|OTHER||Vaccine Efficacy|70.5|||||TWO_SIDED|95.0|49.4|83.6||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||83.6|49.4|
70930105|NCT04424316|141358227|OTHER||Vaccine Efficacy|70.0|||||TWO_SIDED|95.0|50.6|82.5||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||82.5|50.6|
71015545|NCT00965562|141538559|SUPERIORITY_OR_OTHER||Slope|-0.17||||0.36|TWO_SIDED|95.0|-0.54|0.2|||Mixed Models Analysis||Slope represents average change in calcium group CGI-S scores as compared to placebo|||0.20|-0.54|0.36
71015546|NCT00965562|141538559|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.92||||0.07|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the fluoxetine group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.07
71015547|NCT00965562|141538559|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.44||||0.36|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the calcium group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.36
71015548|NCT00965562|141538560|SUPERIORITY_OR_OTHER||Slope|-0.28||||0.02|TWO_SIDED|95.0|-0.53|-0.04|||Mixed Models Analysis||Slope represents average change in fluoxetine group DRSP scores as compared to placebo|||-0.04|-0.53|0.02
71015549|NCT00965562|141538560|SUPERIORITY_OR_OTHER||Slope|0.06||||0.58|TWO_SIDED|95.0|-0.16|0.28|||Mixed Models Analysis||Slope represents average change in calcium group DRSP scores as compared to placebo|||0.28|-0.16|0.58
71015550|NCT00965562|141538560|SUPERIORITY_OR_OTHER||Cohen's d effect size|2.08||||0.02|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the fluoxetine group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.02
71049641|NCT02504671|141606190|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71049642|NCT02504671|141606190|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71049643|NCT02504671|141606190|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
70930106|NCT04424316|141358243|OTHER||Vaccine efficacy|69.7|||||TWO_SIDED|95.0|37.1|86.7||||||Vaccine efficacy within 90 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||86.7|37.1|
70930107|NCT04424316|141358243|OTHER||Vaccine efficacy|61.5|||||TWO_SIDED|95.0|28.6|80.3||||||Vaccine efficacy within 120 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||80.3|28.6|
70930108|NCT04424316|141358243|OTHER||Vaccine efficacy|57.1|||||TWO_SIDED|95.0|23.9|76.8||||||Vaccine efficacy within 150 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||76.8|23.9|
70930109|NCT04424316|141358243|OTHER||Vaccine efficacy|55.3|||||TWO_SIDED|95.0|23.8|74.6||||||Vaccine efficacy within 180 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||74.6|23.8|
70930110|NCT04424316|141358243|OTHER||Vaccine efficacy|24.2|||||TWO_SIDED|95.0|-11.1|48.6||||||Vaccine efficacy within 360 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||48.6|-11.1|
70930111|NCT04424316|141358244|OTHER||Vaccine efficacy|9.5|||||TWO_SIDED|95.0|-10.1|25.7||||||Vaccine efficacy within 90 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||25.7|-10.1|
70930112|NCT04424316|141358244|OTHER||Vaccine efficacy|6.7|||||TWO_SIDED|95.0|-9.8|20.7||||||Vaccine efficacy within 120 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||20.7|-9.8|
70930113|NCT04424316|141358244|OTHER||Vaccine efficacy|7.7|||||TWO_SIDED|95.0|-6.5|20.1||||||Vaccine efficacy within 150 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||20.1|-6.5|
70930114|NCT04424316|141358244|OTHER||Vaccine efficacy|4.1|||||TWO_SIDED|95.0|-9.5|16.0||||||Vaccine efficacy within 180 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||16.0|-9.5|
70930115|NCT04424316|141358244|OTHER||Vaccine efficacy|4.6|||||TWO_SIDED|95.0|-6.6|14.6||||||Vaccine efficacy within 360 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||14.6|-6.6|
70930116|NCT04424316|141358245|OTHER||Vaccine efficacy|43.8|||||TWO_SIDED|95.0|25.6|57.7||||||Vaccine efficacy at 210 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||57.7|25.6|
70930117|NCT04424316|141358245|OTHER||Vaccine efficacy|39.7|||||TWO_SIDED|95.0|21.3|54.1||||||Vaccine efficacy at 240 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||54.1|21.3|
71015551|NCT00965562|141538560|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.18||||0.58|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the calcium group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.58
71015552|NCT00965562|141538561|SUPERIORITY_OR_OTHER||Slope|-1.03||||0.04|TWO_SIDED|95.0|-1.7|-0.35|||Mixed Models Analysis||Slope represents average change in fluoxetine group CGI Improvement scores as compared to placebo|||-0.35|-1.70|0.04
71015553|NCT00965562|141538561|SUPERIORITY_OR_OTHER||Slope|-0.2||||0.54|TWO_SIDED|95.0|-0.86|0.46|||Mixed Models Analysis||Slope represents average change in calcium group CGI Improvement scores as compared to placebo|||0.46|-0.86|0.54
71049644|NCT02504671|141606190|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71049645|NCT02504671|141606190|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71104652|NCT01098747|141716670|SUPERIORITY_OR_OTHER||LS mean difference|3.4|||<|0.001|TWO_SIDED|95.0|2.66|4.14||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.14|2.66|<0.001
70850647|NCT02712047|141189439|OTHER||Mean Difference (Net)|0.24|||||TWO_SIDED|95.0|0.14|0.34|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 4, AM|||0.34|0.14|
71049646|NCT02504671|141606190|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049647|NCT02504671|141606190|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
70930118|NCT04424316|141358245|OTHER||Vaccine efficacy|35.0|||||TWO_SIDED|95.0|16.1|49.9||||||Vaccine efficacy at 270 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||49.9|16.1|
70930119|NCT04424316|141358245|OTHER||Vaccine efficacy|33.0|||||TWO_SIDED|95.0|15.2|47.1||||||Vaccine efficacy at 360 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||47.1|15.2|
70930120|NCT00412607|141358266|SUPERIORITY_OR_OTHER_LEGACY||Percentage of mortality|13.3|||||ONE_SIDED|95.0||17.5|||Fisher Exact||The 95% confidence interval is a one-sided with upper confidence level = 17.5% computed using the exact binomial test.|"Assumptions for sample size calculation: 10% attrition rate, Type I error of 0.05, anticipated 12-month mortality rate is 0.19, a region of indifference of 0.07, power of 0.8; the required sample size is 249 per nQuery Exact test for single proportion method.~The null hypothesis is that the 12-month mortality rate is greater than or equal to 0.26; the alternative is that the rate is less than 0.26. This hypothesis is evaluated with one-sided exact binomial test at α= 0.05."||17.5||
70930121|NCT04109066|141358273|SUPERIORITY||Odds Ratio (OR)|2.05||||0.0021|TWO_SIDED|95.0|1.29|3.27|||Cochran-Mantel-Haenszel||"Stratified by PD-L1 by SP142 (\< 1% vs. \>= 1%), AC Dose-Frequency Chemotherapy Regimen (Q2W vs. Q3W) per IRT.~Strata adjusted odds ratio (Arm A over Arm B) using Mantel-Haenszel method."|Arm A over Arm B||3.27|1.29|0.0021
70930122|NCT04109066|141358273|OTHER||Adjusted Difference of pCR Rates|10.5|||||TWO_SIDED|95.0|4.0|16.9|||||"Strata adjusted difference in pCR (Arm A-B) based on Cochran-Mantel-Haenszel (CMH) method of weighting.~Stratified by PD-L1 by SP142 (\< 1% vs. \>= 1%), AC Dose-Frequency Chemotherapy Regimen (Q2W vs. Q3W) per IRT."|||16.9|4.0|
70930123|NCT04109066|141358274|SUPERIORITY||Odds Ratio (OR)|3.11|||||TWO_SIDED|95.0|1.58|6.11|||||Stratified by AC Dose-Frequency. Chemotherapy Regimen (Q2W vs. Q3W) per IRT. Strata adjusted odds ratio (Arm A over Arm B) using Mantel-Haenszel method.|Arm A over Arm B||6.11|1.58|
71015554|NCT00965562|141538561|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.8||||0.04|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the fluoxetine group between visits 2 and 5 and changes in the placebo group between Visits 2 and 5, divided by the std dev in the placebo group at Visit 5|||||0.04
70930124|NCT04109066|141358274|OTHER||Adjusted Difference of pCR Rates|24.1|||||TWO_SIDED|95.0|10.7|37.5|||||"Strata adjusted difference in pCR (Arm A-B) based on Cochran-Mantel-Haenszel (CMH) method of weighting.~Stratified by AC Dose-Frequency Chemotherapy Regimen (Q2W vs. Q3W) per IRT."|||37.5|10.7|
70930125|NCT04675034|141358314|SUPERIORITY||Combined estimate for LS mean|-0.15|STANDARD_ERROR_OF_MEAN|0.416||0.36|TWO_SIDED|95.0|-0.968|0.67|||ANCOVA|Least Square (LS) mean and treatment group difference with associated 95% confidence intervals (CIs) are modelled using ANCOVA on imputed data.||||0.670|-0.968|0.360
70930126|NCT04675034|141358314|SUPERIORITY||Combined estimate for LS mean|-0.8|STANDARD_ERROR_OF_MEAN|0.418||0.029|TWO_SIDED|95.0|-1.619|0.027|||ANCOVA|Least Square mean and treatment group difference with associated 95% CIs are modelled using ANCOVA on imputed data.||||0.027|-1.619|0.029
70930127|NCT04675034|141358314|SUPERIORITY||Combined estimate for LS mean|-0.8|STANDARD_ERROR_OF_MEAN|0.413||0.026|TWO_SIDED|95.0|-1.618|0.009|||ANCOVA|Least Square mean and treatment group difference with associated 95% CIs are modelled using ANCOVA on imputed data.||||0.009|-1.618|0.026
71049648|NCT02504671|141606190|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049649|NCT02504671|141606190|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
70850648|NCT02712047|141189439|OTHER||Mean Difference (Net)|0.17|||||TWO_SIDED|95.0|0.07|0.27|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 4, PM|||0.27|0.07|
70930128|NCT04675034|141358314|SUPERIORITY||Combined estimate for LS mean|-0.59|STANDARD_ERROR_OF_MEAN|0.424||0.083|TWO_SIDED|95.0|-1.423|0.245|||ANCOVA|Least Square mean and treatment group difference with associated 95% CIs are modelled using ANCOVA on imputed data.||||0.245|-1.423|0.083
71015555|NCT00965562|141538561|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.32||||0.54|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the calcium group between visits 2 and 5 and changes in the placebo group between Visits 2 and 5, divided by the std dev in the placebo group at Visit 5|||||0.54
71049650|NCT02504671|141606190|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049651|NCT02504671|141606190|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 2. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049652|NCT02504671|141606190|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 4. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049653|NCT02504671|141606190|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
70930129|NCT04163991|141358344|SUPERIORITY||Least Squares (LS) Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.38||0.0296|TWO_SIDED|90.0|-1.47|-0.21||Results are from MMRM analysis with treatment, visit, visit by treatment interaction, and baseline DAS28-CRP score included in the model.|MMRM||LS Mean difference is VIB4920 minus placebo. Differences less than 0 favor VIB4920.|||-0.21|-1.47|0.0296
70930130|NCT04163991|141358344|SUPERIORITY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.38||0.0355|TWO_SIDED|90.0|-1.44|-0.18||Results are from MMRM analysis with treatment, visit, visit by treatment interaction, and baseline DAS28-CRP score included in the model.|MMRM||LS Mean difference is VIB4920 minus placebo. Differences less than 0 favor VIB4920.|||-0.18|-1.44|0.0355
70930131|NCT04163991|141358344|SUPERIORITY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.38||0.0364|TWO_SIDED|90.0|-1.44|-0.18||Results are from MMRM analysis with treatment, visit, visit by treatment interaction, and baseline DAS28-CRP score included in the model.|MMRM||LS Mean difference is VIB4920 minus placebo. Differences less than 0 favor VIB4920.|||-0.18|-1.44|0.0364
70930132|NCT04163991|141358344|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.38||0.0478|TWO_SIDED|90.0|-1.41|-0.13||Results are from MMRM analysis with treatment, visit, visit by treatment interaction, and baseline DAS28-CRP score included in the model.|MMRM||LS Mean difference is VIB4920 minus placebo. Differences less than 0 favor VIB4920.|||-0.13|-1.41|0.0478
71015556|NCT02062385|141538602|SUPERIORITY_OR_OTHER||1 - (Incidence V260 / Incidence Placebo)|69.3|||<|0.001|TWO_SIDED|95.0|54.5|79.7|||Clopper-Pearson|To calculate the confidence interval and associated p-value, an exact conditional method based on a Poisson distribution was used.||V260 will be considered efficacious if the lower bound of the two-sided confidence interval for efficacy is \>0% at the final analysis||79.7|54.5|<0.001
71015557|NCT04074109|141538610|OTHER|This is a feasibility study which is not powered for efficacy. Therefore no formal statistical tests are used.||||||||||||This is a feasibility study which is not powered for efficacy. Therefore no formal statistical tests are used.|||||This is a feasibility study which is not powered for efficacy. Therefore no formal statistical tests are used.|||
71015558|NCT04074109|141538610|OTHER|||||||||||||||||This is a feasibility study which is not powered for efficacy. Therefore no formal statistical tests are used. We report percentages and frequencies to show feasibility|This is a feasibility study which is not powered for efficacy. Therefore no formal statistical tests are used.|||
71015559|NCT01939834|141538621|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71015560|NCT00795210|141538630|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Kruskal-Wallis|||Kruskal-Wallis Test for overall difference between groups||||0.01
71049654|NCT02504671|141606190|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049655|NCT02504671|141606190|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
71104653|NCT01098747|141716670|SUPERIORITY_OR_OTHER||LS mean difference|-0.4||||0.139|TWO_SIDED|95.0|-0.93|0.13||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.13|-0.93|0.139
71015561|NCT00795210|141538631|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||ANOVA|||||||0.42
71015562|NCT03504839|141538633|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
71015563|NCT02060526|141538643|SUPERIORITY_OR_OTHER_LEGACY||Difference between proportions|0.286||||0.4615|TWO_SIDED|95.0|-0.297|0.745|||Fisher Exact|||95% exact unconditional confidence interval of the difference in proportion between each of the treatment groups and the untreated control group was considered for the parameter estimation.||0.745|-0.297|0.4615
71015564|NCT02060526|141538643|SUPERIORITY_OR_OTHER_LEGACY||Difference between proportions|0.143||||1|TWO_SIDED|95.0|-0.423|0.647|||Fisher Exact|||95% exact unconditional confidence interval of the difference in proportion between each of the treatment groups and the untreated control group was considered for the parameter estimation.||0.647|-0.423|1.0000
71015565|NCT00471237|141538671|SUPERIORITY||Mean Difference (Net)|0.29|STANDARD_ERROR_OF_MEAN|0.55||0.59|TWO_SIDED|95.0|-0.78|1.37|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.044 at Month 12.||||1.37|-0.78|0.590
71015566|NCT00471237|141538671|SUPERIORITY||Mean Difference (Net)|1.36|STANDARD_ERROR_OF_MEAN|0.55||0.028|TWO_SIDED|95.0|0.28|2.44|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.044 at Month 12||||2.44|0.28|0.028
71015567|NCT00471237|141538671|SUPERIORITY||Mean Difference (Net)|1.58|STANDARD_ERROR_OF_MEAN|0.54||0.011|TWO_SIDED|95.0|0.51|2.65|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.044 at Month 12.||||2.65|0.51|0.011
71015568|NCT00471237|141538671|SUPERIORITY||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|0.55||0.012|TWO_SIDED|95.0|0.51|2.69|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.044 at Month 12.||||2.69|0.51|0.012
71049656|NCT02504671|141606190|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
71049657|NCT02504671|141606190|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
71049658|NCT02504671|141606190|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
71049659|NCT02504671|141606190|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049660|NCT02504671|141606190|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
70930133|NCT04163991|141358355|SUPERIORITY||Ratio of geometric mean versus placebo|0.64||||0.0584|TWO_SIDED|90.0|0.43|0.94||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||0.94|0.43|0.0584
70930134|NCT04163991|141358355|OTHER||Ratio of geometric mean versus placebo|0.76||||0.2274|TWO_SIDED|90.0|0.51|1.11||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||1.11|0.51|0.2274
71015569|NCT00471237|141538679|SUPERIORITY||Mean Difference (Net)|-0.45|STANDARD_ERROR_OF_MEAN|0.47||0.68|TWO_SIDED|95.0|-1.38|0.48|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.006 at Month 6.||||0.48|-1.38|0.680
71015570|NCT00471237|141538679|SUPERIORITY||Mean Difference (Net)|0.95|STANDARD_ERROR_OF_MEAN|0.48||0.192|TWO_SIDED|95.0|0.01|1.89|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.006 at Month 6.||||1.89|0.01|0.192
71015571|NCT00471237|141538679|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.47||0.68|TWO_SIDED|95.0|-1.12|0.73|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.006 at Month 6.||||0.73|-1.12|0.680
71015572|NCT00471237|141538679|SUPERIORITY||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.48||0.68|TWO_SIDED|95.0|-0.59|1.29|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.006 at Month 6.||||1.29|-0.59|0.680
71015573|NCT00471237|141538680|SUPERIORITY||Mean Difference (Net)|-0.68|STANDARD_ERROR_OF_MEAN|0.33||0.037|TWO_SIDED|95.0|-1.32|-0.04|||ANOVA|||Total Hip aBMD, Month 6||-0.04|-1.32|0.037
71049661|NCT02504671|141606190|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|12.7|||||Index based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-2.5|
71104654|NCT01098747|141716670|SUPERIORITY_OR_OTHER||LS mean difference|3.2|||<|0.001|TWO_SIDED|95.0|2.44|3.95||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.95|2.44|<0.001
71015574|NCT00471237|141538680|SUPERIORITY||Mean Difference (Net)|-0.79|STANDARD_ERROR_OF_MEAN|0.33||0.017|TWO_SIDED|95.0|-1.43|-0.14|||ANOVA|||Total Hip aBMD, Month 6||-0.14|-1.43|0.017
71015575|NCT00471237|141538680|SUPERIORITY||Mean Difference (Net)|-1.28|STANDARD_ERROR_OF_MEAN|0.32||0|TWO_SIDED|95.0|-1.92|-0.64|||ANOVA|||Total Hip aBMD, Month 6||-0.64|-1.92|0.000
71015576|NCT00471237|141538680|SUPERIORITY||Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|0.33||0|TWO_SIDED|95.0|-1.95|-0.65|||ANOVA|||Total Hip aBMD, Month 6||-0.65|-1.95|0.000
71015577|NCT00471237|141538680|SUPERIORITY||Mean Difference (Net)|-0.89|STANDARD_ERROR_OF_MEAN|0.36||0.015|TWO_SIDED|95.0|-1.61|-0.17|||ANOVA|||Total Hip aBMD, Month 12||-0.17|-1.61|0.015
71015578|NCT00471237|141538680|SUPERIORITY||Mean Difference (Net)|-1.02|STANDARD_ERROR_OF_MEAN|0.37||0.006|TWO_SIDED|95.0|-1.74|-0.3|||ANOVA|||Total Hip aBMD, Month 12||-0.30|-1.74|0.006
71015579|NCT00471237|141538680|SUPERIORITY||Mean Difference (Net)|-1.33|STANDARD_ERROR_OF_MEAN|0.36||0|TWO_SIDED|95.0|-2.04|-0.63|||ANOVA|||Total Hip aBMD, Month 12||-0.63|-2.04|0.000
71015580|NCT00471237|141538680|SUPERIORITY||Median Difference (Net)|-1.57|STANDARD_ERROR_OF_MEAN|0.37||0|TWO_SIDED|95.0|-2.3|-0.84|||ANOVA|||Total Hip aBMD, Month 12||-0.84|-2.30|0.000
71015581|NCT00627094|141538695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.0438|TWO_SIDED|95.0|1.02|2.96||In order to obtain 90% power to show superiority of Biatain Ibu compared to Biatain, a sample size of 60 pts per group (assuming a 15% drop-out rate) was found by simulating data from multi-nomial distributions over time.|Chi-squared|Result based on ITT population (evening). PP-analysis show a strong tendency (not significant) in favour of Biatain Ibu supporting the ITT-analysis||The null hypothesis to be tested was that the distributions of categorical responses were the same.||2.96|1.02|0.0438
71015582|NCT01040624|141538699|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Chi-squared|One-sided binomial test of univariate probability distributions||||||<0.0001
71015583|NCT01353586|141538703|SUPERIORITY_OR_OTHER||Proportion of events|71.6|||||TWO_SIDED|95.0|63.3|79.8|||||The above supplemental analysis is to estimate the rate of subjects without documented symptomatic AF at Day 240 using the Kaplan-Meier time-to-event analysis method to accommodate the censored information from the two withdrawn subjects.|||79.8|63.3|
71015584|NCT00585468|141538710|SUPERIORITY_OR_OTHER|||||||0.0163|||||||t-test, 2 sided|||||||0.0163
71015585|NCT00585468|141538711|SUPERIORITY_OR_OTHER|||||||0.039|||||||t-test, 2 sided|||||||0.039
71015586|NCT00585468|141538713|SUPERIORITY_OR_OTHER|||||||0.146|||||||t-test, 2 sided|||||||0.146
71015587|NCT00585468|141538714|SUPERIORITY_OR_OTHER|||||||0.4937|||||||t-test, 2 sided|||||||0.4937
71015588|NCT00585468|141538715|SUPERIORITY_OR_OTHER|||||||0.9669|||||||t-test, 2 sided|||||||0.9669
71015589|NCT00585468|141538717|SUPERIORITY_OR_OTHER|||||||0.9607|||||||t-test, 2 sided|||||||0.9607
71015590|NCT03056456|141538724|SUPERIORITY||Ratio of Geometric LS Means|1.0|||||TWO_SIDED|90.0|0.81|1.23||||||Day 1||1.23|0.810|
71015591|NCT03056456|141538724|SUPERIORITY||Ratio of Geometric LS Means|1.01|||||TWO_SIDED|90.0|0.817|1.25||||||Day 3||1.25|0.817|
71015592|NCT03056456|141538725|SUPERIORITY||Ratio of Geometric LS Means|1.03|||||TWO_SIDED|90.0|0.808|1.31||||||Day 1||1.31|0.808|
71015593|NCT03056456|141538725|SUPERIORITY|Day 3|Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|0.82|1.32||||||||1.32|0.820|
71049662|NCT02504671|141606190|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|68.2|||||Index based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||68.2|-1.9|
71049663|NCT02504671|141606190|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
70850649|NCT02712047|141189439|OTHER||Mean Difference (Net)|0.07|||||TWO_SIDED|95.0|-0.03|0.17|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 5, AM|||0.17|-0.03|
71049664|NCT02504671|141606190|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71104655|NCT01098747|141716670|SUPERIORITY_OR_OTHER||LS mean difference|-0.41||||0.144|TWO_SIDED|95.0|-0.95|0.14||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.14|-0.95|0.144
71104656|NCT01098747|141716670|SUPERIORITY_OR_OTHER||LS mean difference|2.8|||<|0.001|TWO_SIDED|95.0|2.01|3.58||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.58|2.01|<0.001
71104657|NCT01098747|141716670|SUPERIORITY_OR_OTHER||LS mean difference|-0.58||||0.043|TWO_SIDED|95.0|-1.15|-0.02||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||-0.02|-1.15|0.043
71104658|NCT01098747|141716670|SUPERIORITY_OR_OTHER||LS mean difference|2.33|||<|0.001|TWO_SIDED|95.0|1.53|3.12||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.12|1.53|<0.001
71104659|NCT01098747|141716670|SUPERIORITY_OR_OTHER||LS mean difference|-0.59||||0.044|TWO_SIDED|95.0|-1.16|-0.02||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||-0.02|-1.16|0.044
71104660|NCT01098747|141716670|SUPERIORITY_OR_OTHER||LS mean difference|2.05|||<|0.001|TWO_SIDED|95.0|1.25|2.85||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.85|1.25|<0.001
71104661|NCT01098747|141716670|SUPERIORITY_OR_OTHER||LS mean difference|-0.65||||0.027|TWO_SIDED|95.0|-1.23|-0.08||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||-0.08|-1.23|0.027
71104662|NCT01098747|141716671|SUPERIORITY_OR_OTHER||LS mean difference|2.73|||<|0.001|TWO_SIDED|95.0|2.27|3.18||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.18|2.27|<0.001
70850650|NCT02712047|141189439|OTHER||Mean Difference (Net)|0.04|||||TWO_SIDED|95.0|-0.06|0.14|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 7, AM|||0.14|-0.06|
70850651|NCT02712047|141189439|OTHER||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.07|0.13|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 21, AM|||0.13|-0.07|
71049665|NCT02504671|141606190|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71049666|NCT02504671|141606190|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71049667|NCT02504671|141606190|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71049668|NCT02504671|141606190|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71049669|NCT02504671|141606190|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71049670|NCT02504671|141606190|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049671|NCT02504671|141606190|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049672|NCT02504671|141606190|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71049673|NCT02504671|141606190|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049674|NCT02504671|141606190|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71049675|NCT02504671|141606190|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71015594|NCT00943826|141538743|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64|||<|0.0001|TWO_SIDED|95.0|0.55|0.74||Stratified by Region and Recursive partitioning analysis (RPA) Class|Log Rank||Stratified by Region and RPA Class.|||0.74|0.55|<0.0001
71015595|NCT00943826|141538744|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.0987|TWO_SIDED|95.0|0.76|1.02|||Log Rank|Stratified by Region and RPA Class|Stratified by Region and RPA Class.|||1.02|0.76|0.0987
71049676|NCT02504671|141606190|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049677|NCT02504671|141606190|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049678|NCT02504671|141606190|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71049679|NCT02504671|141606190|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049680|NCT02504671|141606190|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71015596|NCT00943826|141538745|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.53|0.71||Stratified by Region and RPA Class.|Log Rank||Stratified by Region and RPA Class.|||0.71|0.53|<0.0001
71015597|NCT00517868|141538750|NON_INFERIORITY|A paired student t comparison was used to assess treatment differences as measured by 11 point numerical rating scale.|Mean Difference (Final Values)|-21.14||||0.0363|TWO_SIDED|95.0|-44.43|2.16|||t-test, 1 sided|||||2.16|-44.43|0.0363
71015598|NCT00807040|141538756|OTHER|We tested this hypothesis in an intention-to-treat analysis using a two-tailed Wilcoxon rank-sum test, at a 0.05 alpha level. This analysis accommodated nonignorable missing LVESVI outcomes owing to the death of patients by assigning deceased patients the worst ranks in order on the basis of the time of death. We used multiple imputation for data that were missing for reasons other than death to calculate the 12-month LVESVI on the assumption that the data were missing at random.||||||0.18|||||||Wilcoxon (Mann-Whitney)|||The trial was designed with a power of 90% to detect a between-group difference of 15 ml per square meter in the LVESVI from baseline to 12 months. We assumed a baseline LVESVI of 100 ml per square meter, improvements of 20 ml per square meter in the repair group and 35 ml per square meter in the replacement group, and equal 1-year mortality of 10 to 20% in the two groups. The primary null hypothesis was that there would be no between-group difference in the LVESVI at 12 months.||||0.18
71049681|NCT02504671|141606191|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049682|NCT02504671|141606191|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71049683|NCT02504671|141606191|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049684|NCT02504671|141606191|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049685|NCT02504671|141606191|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049686|NCT02504671|141606191|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71049687|NCT02504671|141606191|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049688|NCT02504671|141606191|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71049689|NCT02504671|141606191|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049690|NCT02504671|141606191|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71015599|NCT00807040|141538757|OTHER|We used the log-rank test to compare rates of death from baseline to 2 years.|Hazard Ratio (HR)|0.79||||0.39|TWO_SIDED|95.0|0.46|1.35|||Log Rank|||||1.35|0.46|0.39
71015600|NCT02234427|141538782|SUPERIORITY_OR_OTHER||||||<|5e-06||||||Above noted p-value is adjusted for multiple comparisons. Analysis was performed using the TopHat/Cufflinks pipeline. The differential expression algorithm uses a beta distribution and the overdispersion with a negative binomial distribution.|negative binomial|||Null Hypothesis: There is no difference in gene expression before and after aspirin therapy||||<0.000005
71015601|NCT02279888|141538811|OTHER|the lower limit of the two-sided 95% confidence interval on the freedom from DSRC rate at 24 months is greater than 80%|Kaplan Meier|0.05|||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71015602|NCT02279888|141538813|OTHER||Hazard Ratio (HR)|0.43|||<|0.0001|TWO_SIDED|95.0|0.39|0.47|||Andersen-Gill||This analysis applies to Primary Outcome: HFH Rate|||0.47|0.39|<0.0001
71015603|NCT02279888|141538815|OTHER||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.52|0.62|||Andersen-Gill|||||0.62|0.52|<0.0001
71015604|NCT00650806|141538853|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.4||0.031|TWO_SIDED|95.0|-1.6|-0.1|||ANOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center.||||-0.1|-1.6|0.031
71049691|NCT02504671|141606191|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049692|NCT02504671|141606191|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049693|NCT02504671|141606191|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71049694|NCT02504671|141606191|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71015605|NCT00650806|141538853|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.4|-0.8|||ANOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center.||||-0.8|-2.4|<0.001
71015606|NCT00650806|141538853|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.1|-0.6|||ANOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center.||||-0.6|-2.1|<0.001
71015607|NCT00650806|141538854|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.4||0.045|TWO_SIDED|95.0|-1.58|-0.02|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. Baseline body weight was a covariate.||||-0.02|-1.58|0.045
71015608|NCT00650806|141538854|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-2.4|-0.8|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. Baseline body weight was a covariate.||||-0.80|-2.40|<0.001
71015609|NCT00650806|141538854|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.4||0.001|TWO_SIDED|95.0|-2.07|-0.51|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. Baseline body weight was a covariate.||||-0.51|-2.07|0.001
71015610|NCT00650806|141538855|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.14||0.031|TWO_SIDED|95.0|-0.59|-0.03|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||-0.03|-0.59|0.031
71015611|NCT00650806|141538855|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.9|-0.32|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||-0.32|-0.90|<0.001
71015612|NCT00650806|141538855|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.76|-0.2|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||-0.20|-0.76|<0.001
71015613|NCT00650806|141538856|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.317||95.0|0.6|5.6||P-value controlled for run-in weight loss stratum and pooled center.|Cochran-Mantel-Haenszel||Odds ratio and Confidence Interval controlled for run-in weight loss stratum and pooled center.|||5.6|0.6|0.317
71049695|NCT02504671|141606191|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71049696|NCT02504671|141606191|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71049697|NCT02504671|141606191|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Boolean based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71049698|NCT02504671|141606191|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71049699|NCT02504671|141606191|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049700|NCT02504671|141606191|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049701|NCT02504671|141606191|OTHER||Difference|21.6|||||TWO_SIDED|95.0|0.4|42.8|||||Boolean based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.8|0.4|
70930135|NCT04163991|141358355|SUPERIORITY||Ratio of geometric mean versus placebo|0.77||||0.2794|TWO_SIDED|90.0|0.52|1.14||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||1.14|0.52|0.2794
71049702|NCT02504671|141606191|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Boolean based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71049703|NCT02504671|141606191|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049704|NCT02504671|141606191|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71049705|NCT02504671|141606191|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049706|NCT02504671|141606191|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 2. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049707|NCT02504671|141606191|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049708|NCT02504671|141606191|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049709|NCT02504671|141606191|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049710|NCT02504671|141606191|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049711|NCT02504671|141606191|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049712|NCT02504671|141606191|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049713|NCT02504671|141606191|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049714|NCT02504671|141606191|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049715|NCT02504671|141606191|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049716|NCT02504671|141606191|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049717|NCT02504671|141606191|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049718|NCT02504671|141606191|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049719|NCT02504671|141606191|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049720|NCT02504671|141606191|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049721|NCT02504671|141606191|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049722|NCT02504671|141606191|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71049723|NCT02504671|141606191|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049724|NCT02504671|141606191|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71015614|NCT00650806|141538856|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9||||0.059|TWO_SIDED|95.0|0.9|11.1||P-value controlled for run-in weight loss stratum and pooled center.|Cochran-Mantel-Haenszel||Odds ratio and Confidence Interval controlled for run-in weight loss stratum and pooled center.|||11.1|0.9|0.059
71015615|NCT00650806|141538856|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.1||||0.027|TWO_SIDED|95.0|1.0|10.0||P-value controlled for run-in weight loss stratum and pooled center.|Cochran-Mantel-Haenszel||Odds ratio and Confidence Interval controlled for run-in weight loss stratum and pooled center.|||10.0|1.0|0.027
71015616|NCT00650806|141538857|SUPERIORITY_OR_OTHER|||||||0.117|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlled for run-in weight loss stratum and pooled center.||||||0.117
71015617|NCT00650806|141538857|SUPERIORITY_OR_OTHER|||||||0.225|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlled for run-in weight loss stratum and pooled center.||||||0.225
71015618|NCT00650806|141538857|SUPERIORITY_OR_OTHER|||||||0.317|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlled for run-in weight loss stratum and pooled center.||||||0.317
71015619|NCT00650806|141538858|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|1.23||0.835|TWO_SIDED|95.0|-2.68|2.17|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||2.17|-2.68|0.835
71015620|NCT00650806|141538858|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|1.29||0.466|TWO_SIDED|95.0|-3.47|1.59|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||1.59|-3.47|0.466
71015621|NCT00650806|141538858|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-1.37|STANDARD_ERROR_OF_MEAN|1.25||0.273|TWO_SIDED|95.0|-3.87|1.09|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||1.09|-3.87|0.273
71015622|NCT00650806|141538859|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.63|STANDARD_ERROR_OF_MEAN|1.13||0.149|TWO_SIDED|95.0|-3.85|0.59|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||0.59|-3.85|0.149
71015623|NCT00650806|141538859|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|1.18||0.541|TWO_SIDED|95.0|-3.05|1.6|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||1.6|-3.05|0.541
71015624|NCT00650806|141538859|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.78|STANDARD_ERROR_OF_MEAN|1.15||0.121|TWO_SIDED|95.0|-4.03|0.47|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||0.47|-4.03|0.121
71015625|NCT00650806|141538860|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.011|STANDARD_ERROR_OF_MEAN|0.0091||0.239|TWO_SIDED|95.0|-0.0071|0.0286|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||0.0286|-0.0071|0.239
71015626|NCT00650806|141538860|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.001|STANDARD_ERROR_OF_MEAN|0.0095||0.9|TWO_SIDED|95.0|-0.0174|0.0198|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||0.0198|-0.0174|0.900
71015627|NCT00650806|141538860|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.002|STANDARD_ERROR_OF_MEAN|0.0092||0.822|TWO_SIDED|95.0|-0.016|0.0202|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||0.0202|-0.0160|0.822
71015628|NCT03707145|141538862|SUPERIORITY||Partial Eta Squared|0.058|||||TWO_SIDED|||||||||Partial Eta Squared was calculated based on ANOVA with Time (pre-post) as within subject factor and Empowerment (Professional led versus Patient Empowered) as between subject factor.||||
71015629|NCT03707145|141538863|SUPERIORITY||Partial Eta Squared|0.008|||||TWO_SIDED|||||||||Partial Eta Squared was calculated based on ANOVA with Time (pre-post) as within subject factor and Empowerment (Professional led versus Patient Empowered) as between subject factor.||||
71015630|NCT04636437|141538869|SUPERIORITY||Mean Difference (Net)|1.36||||0.23|TWO_SIDED|97.5|-1.2|3.92||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry weight, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in body weight from entry to week 48.||3.92|-1.20|0.23
71015631|NCT04636437|141538869|SUPERIORITY||Mean Difference (Net)|-0.89||||0.41|TWO_SIDED|97.5|-3.34|1.57||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry weight, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in body weight from entry to week 48.||1.57|-3.34|0.41
71015632|NCT04636437|141538870|SUPERIORITY||Mean Difference (Net)|0.83||||0.31|TWO_SIDED|97.5|-0.99|2.64||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry weight, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in body weight from entry to week 24.||2.64|-0.99|0.31
71015633|NCT04636437|141538870|SUPERIORITY||Mean Difference (Net)|-1.99||||0.012|TWO_SIDED|97.5|-3.76|-0.21||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry weight, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in body weight from entry to week 24.||-0.21|-3.76|0.012
71049725|NCT02504671|141606191|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71015634|NCT04636437|141538871|SUPERIORITY||Mean Difference (Net)|1.72||||0.2|TWO_SIDED|97.5|-1.33|4.77||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry waist circumference, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in waist circumference from entry to week 48.||4.77|-1.33|0.20
71015635|NCT04636437|141538871|SUPERIORITY||Mean Difference (Net)|-1.49||||0.25|TWO_SIDED|97.5|-4.43|1.44||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry waist circumference, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in waist circumference from entry to week 48.||1.44|-4.43|0.25
71015636|NCT04636437|141538872|SUPERIORITY||Mean Difference (Net)|-0.16||||0.9|TWO_SIDED|97.5|-3.23|2.9||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry waist circumference, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in waist circumference from entry to week 24.||2.90|-3.23|0.90
71015637|NCT04636437|141538872|SUPERIORITY||Mean Difference (Net)|-1.48||||0.26|TWO_SIDED|97.5|-4.47|1.51||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry waist circumference, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in waist circumference from entry to week 24.||1.51|-4.47|0.26
71049726|NCT02504671|141606191|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049727|NCT02504671|141606191|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049728|NCT02504671|141606191|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Boolean based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71015638|NCT04636437|141538873|SUPERIORITY||Mean Difference (Net)|1.19||||0.91|TWO_SIDED|97.5|-22.2|24.59||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting triglycerides, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting triglycerides from entry to week 48.||24.59|-22.2|0.91
71015639|NCT04636437|141538873|SUPERIORITY||Mean Difference (Net)|-7.1||||0.48|TWO_SIDED|97.5|-29.7|15.47||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting triglycerides, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting triglycerides from entry to week 48.||15.47|-29.7|0.48
71015640|NCT04636437|141538874|SUPERIORITY||Mean Difference (Net)|-15.2||||0.3|TWO_SIDED|97.5|-48.6|18.2||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting triglycerides, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting triglycerides from entry to week 24.||18.20|-48.6|0.30
71049729|NCT02504671|141606191|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049730|NCT02504671|141606191|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049731|NCT02504671|141606191|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049732|NCT02504671|141606191|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049733|NCT02504671|141606191|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049734|NCT02504671|141606192|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 4, Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049735|NCT02504671|141606192|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049736|NCT02504671|141606192|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||CDAI, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
71049737|NCT02504671|141606192|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||CDAI, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
70930136|NCT04163991|141358355|SUPERIORITY||Ratio of geometric mean versus placebo|0.57||||0.0199|TWO_SIDED|90.0|0.39|0.85||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||0.85|0.39|0.0199
70930137|NCT04163991|141358356|SUPERIORITY||Ratio of geometric mean versus placebo|0.64||||0.0007|TWO_SIDED|90.0|0.52|0.79||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||0.79|0.52|0.0007
70930138|NCT04163991|141358356|SUPERIORITY||Ratio of geometric mean versus placebo|0.62||||0.0003|TWO_SIDED|90.0|0.5|0.76||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||0.76|0.50|0.0003
71049738|NCT02504671|141606192|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||CDAI, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
71049739|NCT02504671|141606192|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||CDAI, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
71049740|NCT02504671|141606192|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||CDAI, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
70930139|NCT04163991|141358356|SUPERIORITY||Ratio of geometric mean versus placebo|0.6||||0.0001|TWO_SIDED|90.0|0.48|0.74||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||0.74|0.48|0.0001
70930140|NCT04163991|141358356|SUPERIORITY||Ratio of geometric mean versus placebo|0.47|||<|0.0001|TWO_SIDED|90.0|0.38|0.59||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||0.59|0.38|< 0.0001
70930141|NCT04163991|141358357|SUPERIORITY||Odds Ratio (OR)|1.4||||0.775|TWO_SIDED|90.0|0.2|8.0||Results are from logistic regression analysis with treatment and baseline DAS28-CRP score included in the model.|Regression, Logistic||Odds ratio is VIB4920/placebo, with associated 90% CI and p-value. Odds ratios greater than 1 favor VIB4920.|||8.0|0.2|0.7750
71015641|NCT04636437|141538874|SUPERIORITY||Mean Difference (Net)|-18.5||||0.21|TWO_SIDED|97.5|-51.8|14.76||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting triglycerides, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting triglycerides from entry to week 24.||14.76|-51.8|0.21
71015642|NCT04636437|141538875|SUPERIORITY||Mean Difference (Net)|-2.84||||0.58|TWO_SIDED|97.5|-14.4|8.72||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting LDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting LDL from entry to week 48.||8.72|-14.4|0.58
71015643|NCT04636437|141538875|SUPERIORITY||Mean Difference (Net)|-6.88||||0.16|TWO_SIDED|97.5|-18.0|4.2||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting LDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting LDL from entry to week 48.||4.20|-18.0|0.16
71049741|NCT02504671|141606192|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||CDAI, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
71049742|NCT02504671|141606192|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049743|NCT02504671|141606192|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049744|NCT02504671|141606192|OTHER||Difference|16.2|||||TWO_SIDED|95.0|4.3|28.1|||||CDAI, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|4.3|
71049745|NCT02504671|141606192|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049746|NCT02504671|141606192|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71049747|NCT02504671|141606192|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049748|NCT02504671|141606192|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049749|NCT02504671|141606192|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049750|NCT02504671|141606192|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71104663|NCT01098747|141716671|SUPERIORITY_OR_OTHER||LS mean difference|0.45||||0.007|TWO_SIDED|95.0|0.12|0.78||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.78|0.12|0.007
71104664|NCT01098747|141716671|SUPERIORITY_OR_OTHER||LS mean difference|4.29|||<|0.001|TWO_SIDED|95.0|3.6|4.98||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.98|3.60|<0.001
71104665|NCT01098747|141716671|SUPERIORITY_OR_OTHER||LS mean difference|0.37||||0.144|TWO_SIDED|95.0|-0.13|0.87||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.87|-0.13|0.144
71104666|NCT01098747|141716671|SUPERIORITY_OR_OTHER||LS mean difference|8.16|||<|0.001|TWO_SIDED|95.0|6.66|9.66||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-6: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||9.66|6.66|<0.001
71104667|NCT01098747|141716671|SUPERIORITY_OR_OTHER||LS mean difference|-0.23||||0.679|TWO_SIDED|95.0|-1.31|0.85||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-6: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.85|-1.31|0.679
71104668|NCT01098747|141716671|SUPERIORITY_OR_OTHER||LS mean difference|9.94|||<|0.001|TWO_SIDED|95.0|7.92|11.96||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-8: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||11.96|7.92|<0.001
71104669|NCT01098747|141716671|SUPERIORITY_OR_OTHER||LS mean difference|-0.67||||0.367|TWO_SIDED|95.0|-2.12|0.79||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-8: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.79|-2.12|0.367
71104670|NCT01098747|141716672|SUPERIORITY_OR_OTHER||LS mean difference|3.95|||<|0.001|TWO_SIDED|95.0|3.32|4.59||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.59|3.32|< 0.001
71104671|NCT01098747|141716672|SUPERIORITY_OR_OTHER||LS mean difference|0.62||||0.009|TWO_SIDED|95.0|0.16|1.07||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.07|0.16|0.009
71104672|NCT01098747|141716672|SUPERIORITY_OR_OTHER||LS mean difference|6.15|||<|0.001|TWO_SIDED|95.0|5.18|7.12||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||7.12|5.18|<0.001
71104673|NCT01098747|141716672|SUPERIORITY_OR_OTHER||LS mean difference|0.49||||0.166|TWO_SIDED|95.0|-0.21|1.2||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.20|-0.21|0.166
71104674|NCT01098747|141716672|SUPERIORITY_OR_OTHER||LS mean difference|11.67|||<|0.001|TWO_SIDED|95.0|9.54|13.81||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-6: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||13.81|9.54|<0.001
71104675|NCT01098747|141716672|SUPERIORITY_OR_OTHER||LS mean difference|-0.3||||0.703|TWO_SIDED|95.0|-1.84|1.24||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-6: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.24|-1.84|0.703
71104676|NCT01098747|141716672|SUPERIORITY_OR_OTHER||LS mean difference|14.27|||<|0.001|TWO_SIDED|95.0|11.36|17.18||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-8: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||17.18|11.36|<0.001
71104677|NCT01098747|141716672|SUPERIORITY_OR_OTHER||LS mean difference|-1.1||||0.303|TWO_SIDED|95.0|-3.2|1.0||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-8: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.00|-3.20|0.303
71015644|NCT04636437|141538876|SUPERIORITY||Mean Difference (Net)|-2.92||||0.47|TWO_SIDED|97.5|-12.1|6.27||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting LDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting LDL from entry to week 24.||6.27|-12.1|0.47
71015645|NCT04636437|141538876|SUPERIORITY||Mean Difference (Net)|-15.1|||<|0.001|TWO_SIDED|97.5|-24.2|-5.91||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting LDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting LDL from entry to week 24.||-5.91|-24.2|<0.001
71015646|NCT04636437|141538877|SUPERIORITY||Mean Difference (Net)|0.8||||0.79|TWO_SIDED|97.5|-6.17|7.77||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting HDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting HDL from entry to week 48.||7.77|-6.17|0.79
71015647|NCT04636437|141538877|SUPERIORITY||Mean Difference (Net)|-5.46||||0.063|TWO_SIDED|97.5|-12.1|1.16||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting HDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting HDL from entry to week 48.||1.16|-12.1|0.063
71015648|NCT04636437|141538878|SUPERIORITY||Mean Difference (Net)|-1.38||||0.27|TWO_SIDED|97.5|-4.21|1.45||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting HDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting HDL from entry to week 24.||1.45|-4.21|0.27
71015649|NCT04636437|141538878|SUPERIORITY||Mean Difference (Net)|-5.45|||<|0.001|TWO_SIDED|97.5|-8.25|-2.66||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting HDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting HDL from entry to week 24.||-2.66|-8.25|<0.001
71015650|NCT04636437|141538879|SUPERIORITY||Mean Difference (Net)|1.55||||0.77|TWO_SIDED|97.5|-10.3|13.44||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting glucose, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting glucose from entry to week 48.||13.44|-10.3|0.77
71049751|NCT02504671|141606192|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||CDAI, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71049752|NCT02504671|141606192|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71049753|NCT02504671|141606192|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049754|NCT02504671|141606192|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71104678|NCT01098747|141716673|SUPERIORITY_OR_OTHER||LS mean difference|6.68|||<|0.001|TWO_SIDED|95.0|5.6|7.76||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||7.76|5.60|<0.001
71049755|NCT02504671|141606192|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71049756|NCT02504671|141606192|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049757|NCT02504671|141606192|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71049758|NCT02504671|141606192|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71049759|NCT02504671|141606192|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049760|NCT02504671|141606192|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71049761|NCT02504671|141606192|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71049762|NCT02504671|141606192|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049763|NCT02504671|141606192|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||CDAI, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
70930142|NCT04163991|141358357|SUPERIORITY||Odds Ratio (OR)|0.6||||0.6974|TWO_SIDED|90.0|0.1|5.5||Results are from logistic regression analysis with treatment and baseline DAS28-CRP score included in the model.|Regression, Logistic||(Lower limit of 90% CI is \< 0.1.) Odds ratio is VIB4920/placebo, with associated 90% CI and p-value. Odds ratios greater than 1 favor VIB4920.|||5.5|0.1|0.6974
71015651|NCT04636437|141538879|SUPERIORITY||Mean Difference (Net)|-5.23||||0.3|TWO_SIDED|97.5|-16.7|6.2||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting glucose, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting glucose from entry to week 48.||6.20|-16.7|0.30
71015652|NCT04636437|141538880|SUPERIORITY||Mean Difference (Net)|0.18||||0.96|TWO_SIDED|97.5|-8.78|9.15||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting glucose, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting glucose from entry to week 24.||9.15|-8.78|0.96
71015653|NCT04636437|141538880|SUPERIORITY||Mean Difference (Net)|-6.32||||0.11|TWO_SIDED|97.5|-15.2|2.55||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting glucose, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting glucose from entry to week 24.||2.55|-15.2|0.11
71015654|NCT04636437|141538881|SUPERIORITY||Mean Difference (Net)|8.07||||0.16|TWO_SIDED|97.5|-4.93|21.06||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting insulin, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting insulin from entry to week 48.||21.06|-4.93|0.16
71015655|NCT04636437|141538881|SUPERIORITY||Mean Difference (Net)|8.89||||0.1|TWO_SIDED|97.5|-3.37|21.15||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting insulin, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting insulin from entry to week 48.||21.15|-3.37|0.10
70930143|NCT04163991|141358357|SUPERIORITY||Odds Ratio (OR)|0.9||||0.9318|TWO_SIDED|90.0|0.1|5.7||Results are from logistic regression analysis with treatment and baseline DAS28-CRP score included in the model.|Regression, Logistic||Odds ratio is VIB4920/placebo, with associated 90% CI and p-value. Odds ratios greater than 1 favor VIB4920.|||5.7|0.1|0.9318
71015656|NCT04636437|141538882|SUPERIORITY||Mean Difference (Net)|4.28||||0.37|TWO_SIDED|97.5|-6.42|14.99||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting insulin, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting insulin from entry to week 24.||14.99|-6.42|0.37
71015657|NCT04636437|141538882|SUPERIORITY||Mean Difference (Net)|0.37||||0.94|TWO_SIDED|97.5|-10.0|10.77||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting insulin, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting insulin from entry to week 24.||10.77|-10.0|0.94
71015658|NCT04636437|141538883|SUPERIORITY||Mean Difference (Net)|2.77||||0.2|TWO_SIDED|97.5|-2.08|7.63||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry HOMA-IR, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in HOMA-IR from entry to week 48.||7.63|-2.08|0.20
71015659|NCT04636437|141538883|SUPERIORITY||Mean Difference (Net)|2.21||||0.28|TWO_SIDED|97.5|-2.44|6.87||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry HOMA-IR, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in HOMA-IR from entry to week 48.||6.87|-2.44|0.28
71104679|NCT01098747|141716673|SUPERIORITY_OR_OTHER||LS mean difference|1.06||||0.007|TWO_SIDED|95.0|0.29|1.84||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||1.84|0.29|0.007
71104680|NCT01098747|141716673|SUPERIORITY_OR_OTHER||LS mean difference|10.43|||<|0.001|TWO_SIDED|95.0|8.79|12.08||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||12.08|8.79|<0.001
71104681|NCT01098747|141716673|SUPERIORITY_OR_OTHER||LS mean difference|0.87||||0.152|TWO_SIDED|95.0|-0.32|2.05||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.05|-0.32|0.152
71104682|NCT01098747|141716673|SUPERIORITY_OR_OTHER||LS mean difference|19.83|||<|0.001|TWO_SIDED|95.0|16.23|23.43||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-6: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||23.43|16.23|<0.001
71104683|NCT01098747|141716673|SUPERIORITY_OR_OTHER||LS mean difference|-0.53||||0.69|TWO_SIDED|95.0|-3.12|2.07||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-6: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.07|-3.12|0.690
71104684|NCT01098747|141716673|SUPERIORITY_OR_OTHER||LS mean difference|-1.77||||0.323|TWO_SIDED|95.0|-5.29|1.75||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-8 Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||1.75|-5.29|0.323
71104685|NCT01098747|141716674|SUPERIORITY_OR_OTHER||Difference in proportion|1.01||||0.49|TWO_SIDED|95.0|-0.97|3.0||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours-Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions and the corresponding standard error.||3.00|-0.97|0.490
71104686|NCT01098747|141716674|SUPERIORITY_OR_OTHER||Difference in proportion|0.54||||0.623|TWO_SIDED|95.0|-1.88|2.95||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.95|-1.88|0.623
71104687|NCT01098747|141716674|SUPERIORITY_OR_OTHER||Difference in proportion|24.36|||<|0.001|TWO_SIDED|95.0|13.51|35.22||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||35.22|13.51|<0.001
71104688|NCT01098747|141716674|SUPERIORITY_OR_OTHER||Difference in proportion|11.82||||0.023|TWO_SIDED|95.0|1.15|22.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||22.48|1.15|0.023
71104689|NCT01098747|141716674|SUPERIORITY_OR_OTHER||Difference in proportion|61.35|||<|0.001|TWO_SIDED|95.0|48.99|73.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||73.70|48.99|<0.001
71015660|NCT04636437|141538884|SUPERIORITY||Mean Difference (Net)|1.79||||0.24|TWO_SIDED|97.5|-1.68|5.25||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry HOMA-IR, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in HOMA-IR from entry to week 24.||5.25|-1.68|0.24
71015661|NCT04636437|141538884|SUPERIORITY||Mean Difference (Net)|-0.57||||0.7|TWO_SIDED|97.5|-3.91|2.78||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry HOMA-IR, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in HOMA-IR from entry to week 24.||2.78|-3.91|0.70
71015662|NCT04636437|141538886|SUPERIORITY|||||||0.43||||||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in occurrence of Grade ≥3 AEs from entry to week 48.||||0.43
71015663|NCT04636437|141538886|SUPERIORITY|||||||0.26||||||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in occurrence of Grade ≥3 AEs from entry to week 48.||||0.26
71015664|NCT04636437|141538887|SUPERIORITY|||||||0.008||||||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in occurrence of \>10% reduction in CrCl from entry to week 48.||||0.008
71049764|NCT02504671|141606192|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049765|NCT02504671|141606192|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||CDAI, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71049766|NCT02504671|141606192|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049767|NCT02504671|141606192|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71049768|NCT02504671|141606192|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049769|NCT02504671|141606192|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 2. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049770|NCT02504671|141606192|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 4. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.6|||7.9|-2.5|
71049771|NCT02504671|141606192|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049772|NCT02504671|141606192|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049773|NCT02504671|141606192|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||CDAI, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
71049774|NCT02504671|141606192|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||CDAI, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
71049775|NCT02504671|141606192|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||CDAI, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
71049776|NCT02504671|141606192|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||CDAI, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
71049777|NCT02504671|141606192|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049778|NCT02504671|141606192|OTHER||5.4|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049779|NCT02504671|141606192|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71049780|NCT02504671|141606192|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049781|NCT02504671|141606192|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71049782|NCT02504671|141606192|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71015665|NCT04636437|141538887|SUPERIORITY|||||||0.068||||||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in occurrence of \>10% reduction in CrCl from entry to week 48.||||0.068
71015666|NCT04636437|141538888|SUPERIORITY|||||||0.2||||||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in occurrence of premature discontinuation of study treatment from entry to week 48.||||0.20
71015667|NCT04636437|141538888|SUPERIORITY|||||||0.56||||||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in occurrence of premature discontinuation of study treatment from entry to week 48.||||0.56
71015668|NCT04636437|141538889|SUPERIORITY||Mean Difference (Net)|3.43||||0.13|TWO_SIDED|97.5|-1.62|8.47||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry total fat, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in total fat from entry to week 48.||8.47|-1.62|0.13
71015669|NCT04636437|141538889|SUPERIORITY||Mean Difference (Net)|-0.09||||0.97|TWO_SIDED|97.5|-4.89|4.72||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry total fat, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in total fat from entry to week 48.||4.72|-4.89|0.97
71015670|NCT04636437|141538890|SUPERIORITY||Mean Difference (Net)|0.31||||0.78|TWO_SIDED|97.5|-2.18|2.8||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry lean mass, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in lean mass from entry to week 48.||2.80|-2.18|0.78
71015671|NCT04636437|141538890|SUPERIORITY||Mean Difference (Net)|1.24||||0.23|TWO_SIDED|97.5|-1.11|3.59||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry lean mass, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in lean mass from entry to week 48.||3.59|-1.11|0.23
71015672|NCT04636437|141538891|SUPERIORITY||Mean Difference (Net)|3.71||||0.18|TWO_SIDED|97.5|-2.48|9.9||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry trunk fat, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in trunk fat from entry to week 48.||9.90|-2.48|0.18
71015673|NCT04636437|141538891|SUPERIORITY||Mean Difference (Net)|-1.35||||0.6|TWO_SIDED|97.5|-7.23|4.53||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry trunk fat, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in trunk fat from entry to week 48.||4.53|-7.23|0.60
71015674|NCT04636437|141538892|SUPERIORITY||Mean Difference (Net)|4.19||||0.094|TWO_SIDED|97.5|-1.45|9.83||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear|||Null hypothesis: There is no difference between the two arms in percent change in limb fat from entry to week 48.|Mean difference and CI come from a linear regression model adjusting for entry limb fat, sex, and race (Black and not Black).|9.83|-1.45|0.094
71015675|NCT04636437|141538892|SUPERIORITY||Mean Difference (Net)|1.76||||0.46|TWO_SIDED|97.5|-3.59|7.11||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear|||Null hypothesis: There is no difference between the two arms in percent change in limb fat from entry to week 48.|Mean difference and CI come from a linear regression model adjusting for entry limb fat, sex, and race (Black and not Black).|7.11|-3.59|0.46
71015676|NCT04636437|141538893|SUPERIORITY||Mean Difference (Net)|2.19||||0.26|TWO_SIDED|97.5|-2.19|6.56||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry appendicular lean mass, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in appendicular lean mass from entry to week 48.||6.56|-2.19|0.26
71015677|NCT04636437|141538893|SUPERIORITY||Mean Difference (Net)|3.15||||0.084|TWO_SIDED|97.5|-0.96|7.25||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry appendicular lean mass, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in appendicular lean mass from entry to week 48.||7.25|-0.96|0.084
71015678|NCT04636437|141538894|SUPERIORITY||Mean Difference (Net)|0.78||||0.19|TWO_SIDED|97.5|-0.57|2.13||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry hip bone mineral density, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in hip bone mineral density from entry to week 48.||2.13|-0.57|0.19
70930144|NCT04163991|141358357|SUPERIORITY||Odds Ratio (OR)|0.9||||0.9108|TWO_SIDED|90.0|0.2|5.1||Results are from logistic regression analysis with treatment and baseline DAS28-CRP score included in the model.|Regression, Logistic||Odds ratio is VIB4920/placebo, with associated 90% CI and p-value. Odds ratios greater than 1 favor VIB4920.|||5.1|0.2|0.9108
71015679|NCT04636437|141538894|SUPERIORITY||Mean Difference (Net)|-0.64||||0.27|TWO_SIDED|97.5|-1.93|0.66||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry hip bone mineral density, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in hip bone mineral density from entry to week 48.||0.66|-1.93|0.27
71015680|NCT04636437|141538895|SUPERIORITY||Mean Difference (Net)|0.5||||0.58|TWO_SIDED|97.5|-1.57|2.58||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry lumbar spine bone mineral density, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in lumbar spine bone mineral density from entry to week 48.||2.58|-1.57|0.58
71015681|NCT04636437|141538895|SUPERIORITY||Mean Difference (Net)|0.05||||0.95|TWO_SIDED|97.5|-1.93|2.03||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry lumbar spine bone mineral density, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in lumbar spine bone mineral density from entry to week 48.||2.03|-1.93|0.95
71015682|NCT01977482|141538964|SUPERIORITY_OR_OTHER||E0 (g/dL)|-0.664|||||TWO_SIDED|95.0|-0.96|-0.387|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||-0.387|-0.960|
71015683|NCT01977482|141538964|SUPERIORITY_OR_OTHER||ED50 (milligrams[mg])|33.531|||||TWO_SIDED|95.0|15.566|48.948|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||48.948|15.566|
70930145|NCT04163991|141358358|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9805|TWO_SIDED|90.0|0.1|10.6||Based on Cox regression method with treatment group included in the model.|Regression, Cox||Hazard ratio is VIB4920/placebo. Hazard ratios less than 1 favor VIB4920.|||10.60|0.10|0.9805
71015684|NCT01977482|141538964|SUPERIORITY_OR_OTHER||Emax (g/dL)|5.234||||||95.0|2.691|7.94|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||7.940|2.691|
71015685|NCT01977482|141538964|SUPERIORITY_OR_OTHER||Gamma|1.145|||||TWO_SIDED|95.0|0.748|1.738|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||1.738|0.748|
71015686|NCT01977482|141538964|SUPERIORITY_OR_OTHER||Var|1.012|||||TWO_SIDED|95.0|0.84|1.234|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||1.234|0.840|
71015687|NCT01977482|141538964|SUPERIORITY_OR_OTHER||Alpha|-0.206|||||TWO_SIDED|95.0|-0.397|-0.014|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||-0.014|-0.397|
70930146|NCT04163991|141358358|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9805|TWO_SIDED|90.0|0.1|10.6||Based on Cox regression method with treatment group included in the model.|Regression, Cox||Hazard ratio is VIB4920/placebo. Hazard ratios less than 1 favor VIB4920.|||10.60|0.10|0.9805
70930147|NCT04163991|141358358|SUPERIORITY||Hazard Ratio (HR)|3.01||||0.3407|TWO_SIDED|90.0|0.45|20.09||Based on Cox regression method with treatment group included in the model.|Regression, Cox||Hazard ratio is VIB4920/placebo. Hazard ratios less than 1 favor VIB4920.|||20.09|0.45|0.3407
70930148|NCT04163991|141358358|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9805|TWO_SIDED|90.0|0.1|10.6||Based on Cox regression method with treatment group included in the model.|Regression, Cox||Hazard ratio is VIB4920/placebo. Hazard ratios less than 1 favor VIB4920.|||10.60|0.10|0.9805
70930149|NCT02510235|141358363|NON_INFERIORITY|"To declare non-inferiority between treatments, a change in the SANDE overall score of 12 mm was required, with an estimated standard deviation of 13 (approximately 70% of the mean at 28 ± 4 days after treatment).~The left inferior limits of confidence interval were determined and compared with the non-inferiority limit defined in the testing hypothesis.~Testing Hypothesis:~H0: meanHyaluronic - meanLubricin ≤ - 12~/ H1: meanHyaluronic - meanLubricin \> - 12"|Mean Difference (Final Values)|1.5|||||ONE_SIDED|95.0|-8.87||||Student t-test for unpaired data.|||Values at Day 28 ± 4 (end of treatment) for the SANDE overall VAS score were compared between treatment groups using a Student's t-test for unpaired data.|||-8.87|
71015688|NCT01977482|141538964|SUPERIORITY_OR_OTHER||Minimally Effective Dose (MED) (mg)|0.418|||||TWO_SIDED|95.0|0.0|2.342|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||2.342|0.000|
71015689|NCT01977482|141538964|SUPERIORITY_OR_OTHER||Dose that achieves a change of -0.25g/dL|2.423|||||TWO_SIDED|95.0|0.0|4.15|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||4.150|0.000|
71015690|NCT01977482|141538964|SUPERIORITY_OR_OTHER||Target Dose (TD) (mg)|4.406|||||TWO_SIDED|95.0|2.544|5.995|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||5.995|2.544|
71015691|NCT01977482|141538964|SUPERIORITY_OR_OTHER||Dose that achieves a change of 0.25 g/dL|6.43|||||TWO_SIDED|95.0|4.698|8.01|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||8.010|4.698|
71049783|NCT02504671|141606192|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||CDAI, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
70930150|NCT02510235|141358365|SUPERIORITY||Mean Difference (Final Values)|-0.77||||0.8226|TWO_SIDED|95.0|-7.66|6.11|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score||Foreign Body Sensation in the Study Eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||6.11|-7.66|0.8226
70930151|NCT02510235|141358365|SUPERIORITY||Mean Difference (Final Values)|3.16||||0.3178|TWO_SIDED|95.0|-3.13|9.44|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Burning/Stinging in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||9.44|-3.13|0.3178
70930152|NCT02510235|141358365|SUPERIORITY||Mean Difference (Final Values)|6.52||||0.0085|TWO_SIDED|95.0|1.74|11.3|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Itching in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||11.30|1.74|0.0085
70930153|NCT02510235|141358365|SUPERIORITY||Mean Difference (Final Values)|3.41||||0.3124|TWO_SIDED|95.0|-3.31|10.13|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Pain in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||10.13|-3.31|0.3124
71015692|NCT01977482|141538964|SUPERIORITY_OR_OTHER||Dose that achieves a change of 0.5 g/dL|8.542|||||TWO_SIDED|95.0|6.931|10.523|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||10.523|6.931|
71015693|NCT01977482|141538964|SUPERIORITY_OR_OTHER||Dose that achieves a change of 0.75 g/dL|10.8|||||TWO_SIDED|95.0|9.024|14.004|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||14.004|9.024|
71015694|NCT01977482|141538964|SUPERIORITY_OR_OTHER||Dose that achieves a change of 1 g/dL|13.248|||||TWO_SIDED|95.0|10.891|18.916|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||18.916|10.891|
71015695|NCT05554471|141539000|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Hypothesis: the time to ambulation for the subjects using the MYNX CONTROL™ Venous VCD was significantly less than for those where manual compression was used.||||<0.001
71015696|NCT05554471|141539001|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Hypothesis: the time to hemostasis for the MYNX CONTROL™ Venous VCD device is at least 5 minutes less than manual compression.||||<0.001
71049784|NCT02504671|141606192|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71049785|NCT02504671|141606192|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
70930154|NCT02510235|141358365|SUPERIORITY||Mean Difference (Final Values)|6.76||||0.0377|TWO_SIDED|95.0|0.4|13.12|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Sticky feeling in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||13.12|0.40|0.0377
70930155|NCT02510235|141358365|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.5321|TWO_SIDED|95.0|-4.62|8.83|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Blurred vision in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||8.83|-4.62|0.5321
70930156|NCT02510235|141358365|SUPERIORITY||Mean Difference (Final Values)|2.32||||0.579|TWO_SIDED|95.0|-6.04|10.68|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Photophobia in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||10.68|-6.04|0.5790
70930157|NCT02510235|141358365|SUPERIORITY||Mean Difference (Final Values)|16.13||||0.3383|TWO_SIDED|95.0|-17.41|49.68|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Total ocular tolerability score in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||49.68|-17.41|0.3383
70930158|NCT02510235|141358366|SUPERIORITY||Mean Difference (Final Values)|-0.94||||0.6484|TWO_SIDED|95.0|-5.07|3.19|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Study Eye analytic statistic is presented. The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||3.19|-5.07|0.6484
70930159|NCT02510235|141358367|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.7408|TWO_SIDED|95.0|-0.71|0.51|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Study Eye analytic statistic is presented. The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.51|-0.71|0.7408
71015697|NCT05554471|141539003|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Hypothesis: The time to discharge eligibility for the subjects using the MYNX CONTROL™ Venous VCD was significantly less than for those where manual compression was used||||<0.001
71015698|NCT00710840|141539008|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||Difference in the change from Preop to 4 weeks Postop|t-test, 2 sided|||The primary outcome, difference in quadriceps torque between intervention (TKA Min) and Control TKA at 4 weeks, was tested using an analysis of covariance model. Confirmatory measures were evaluated at 4 and 12 weeks after surgery in the same way. Baseline characteristics of the treatment groups were compared using 2-sample t tests for continuous measures or a χ2 test for independent proportions for categorical measures. A 2-sided α level of .05 was designated for statistical significance.||||0.07
71015699|NCT00710840|141539009|SUPERIORITY_OR_OTHER|||||||0.92|TWO_SIDED|||||Difference in the change from Preop to 4 weeks Postop|t-test, 2 sided|||||||0.92
71015700|NCT00710840|141539010|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||Difference in the change from Preop to 4 weeks Postop|t-test, 2 sided|||||||0.48
71015701|NCT00710840|141539011|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED|||||Difference in the change from Preop to 4 weeks Postop|t-test, 2 sided|||||||0.41
71015702|NCT04502862|141539012|OTHER||Least square mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.107||0.512|TWO_SIDED|95.0|-0.28|0.14||A hierarchical testing procedure was used to control type I error and handle primary and first 2 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|MMRM|||The MMRM model included study intervention, age, body mass index (BMI), region (Eastern Europe, rest of world \[ROW\]), inhaled corticosteroids \[ICS\] dose level at baseline (ICS dose level medium, ICS dose level high), visit (up to Week 12), study intervention-by-visit interaction, baseline asthma control questionnaire (ACQ-5), baseline sleep disturbance score and baseline-by-visit interaction as covariates.||0.14|-0.28|0.512
71015703|NCT04502862|141539013|OTHER||Least square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.11||0.967|TWO_SIDED|95.0|-0.21|0.22||A hierarchical testing procedure was used to control type I error and handle primary and first 2 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|MMRM|||The MMRM model included study intervention, age, BMI, region (Eastern Europe, ROW), ICS dose level at baseline (ICS dose level medium, ICS dose level high), visit (up to Week 12), study intervention-by-visit interaction, baseline ACQ-5, baseline number of nocturnal awakenings and baseline-by-visit interaction as covariates.||0.22|-0.21|0.967
71015704|NCT04502862|141539014|OTHER||Least square mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.865||0.422|TWO_SIDED|95.0|-2.4|1.01||A hierarchical testing procedure was used to control type I error and handle primary and first 2 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05|MMRM|||The MMRM model included study intervention, age, BMI, region (Eastern Europe, ROW), ICS dose level at baseline (ICS dose level medium, ICS dose level high), visit (up to Week 12), study intervention-by-visit interaction, baseline ACQ-5, baseline PROMIS total score and baseline-by-visit interaction as covariates.||1.01|-2.40|0.422
71015705|NCT00848965|141539025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-2.08|-0.68|||||Treatment difference (FP minus placebo) is presented as the difference in the adjusted means for treatment versus placebo.|||-0.68|-2.08|
71015706|NCT00848965|141539025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55|STANDARD_ERROR_OF_MEAN|0.309|||TWO_SIDED|95.0|-2.16|-0.93|||||Treatment difference (FP minus placebo) is presented as the difference in the adjusted means for treatment versus placebo.|||-0.93|-2.16|
71015707|NCT00848965|141539025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|0.305|||TWO_SIDED|95.0|-2.33|-1.11|||||Treatment difference (FP minus placebo) is presented as the difference in the adjusted means for treatment versus placebo.|||-1.11|-2.33|
71049786|NCT02504671|141606192|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||CDAI, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71049787|NCT02504671|141606192|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049788|NCT02504671|141606192|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71015708|NCT00848965|141539025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.351|||TWO_SIDED|95.0|-2.6|-1.19|||||Treatment difference is presented as the difference in the adjusted means for treatment versus placebo.|||-1.19|-2.60|
71015709|NCT01976104|141539032|SUPERIORITY||Difference of proportion versus placebo|33.7|||=|0.0006|TWO_SIDED|95.0|15.8|51.6|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the scheduled procedure within each Baseline platelet count cohort.|Difference of proportion vs placebo = proportion of Responders for avatrombopag - proportion of Responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the 60 mg avatrombopag and matched placebo treatment groups.||51.6|15.8|=0.0006
71029398|NCT01973348|141566633|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 12 subjects per group has been shown to be effective for estimating within-group means and variances when little prior data is available.(Julius, 2005) Based on collected data from 34 subjects and effective size difference of 0.1, we reestimate this study as a noninferiority trial with continuous outcome and power calculated as approximately 80%.||||||0.88|||||||t-test, 1 sided|||||||0.88
71029399|NCT02724800|141566645|NON_INFERIORITY|non-inferiority margin = 3.43|Mean Difference (Net)|2.2|||<|0.05|TWO_SIDED|95.0|-0.9|5.6||a priori|Mixed Models Analysis|||||5.6|-0.9|<0.05
71029400|NCT02724800|141566652|SUPERIORITY||Mean Difference (Final Values)|2.3|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
71029401|NCT02724800|141566655|SUPERIORITY||Mean Difference (Final Values)|0.3|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
71029402|NCT02458469|141566670|SUPERIORITY|||||||0.019|||||||ANOVA|||||||0.019
71029403|NCT02458469|141566670|SUPERIORITY|||||||0.015|||||||Student-Newman-Keuls Method|||||||0.015
71029404|NCT02458469|141566670|SUPERIORITY|||||||0.231|||||||Student-Newman-Keuls Method|||||||0.231
71029405|NCT02458469|141566671|SUPERIORITY|||||||0.749|||||||ANOVA|||||||0.749
71029406|NCT03561883|141566699|SUPERIORITY||Least squares (LS) mean difference|-0.062||||0.5566|TWO_SIDED|95.0|-0.27|0.146|||MMRM||Treatment difference (IW-3718 - placebo)|Treatment difference calculated as least squares mean (LSM) change from baseline at Week 8; IW-3718 - placebo based on an mixed models repeated measures (MMRM) model with week (categorical), treatment group, week-by-treatment group and week-by-baseline value interactions, baseline esophagitis status (present vs. not present), and baseline WHSS (\< 3 vs. ≥ 3) as fixed effect terms and baseline value as a covariate, with subject as a random effect. An unstructured covariance structure was used.||0.146|-0.270|0.5566
71029407|NCT03561883|141566700|SUPERIORITY||LS mean difference|-0.008||||0.9226|TWO_SIDED|95.0|-0.176|0.159|||MMRM|||Treatment difference calculated as LSM change from baseline at Week 8; IW-3718 - placebo based on an MMRM model with week (categorical), treatment group, week-by-treatment group and week-by-baseline value interactions, baseline esophagitis status (present vs. not present), and baseline WHSS (\< 3 vs. ≥ 3) as fixed effect terms and baseline value as a covariate, with subject as a random effect. An unstructured covariance structure was used.||0.159|-0.176|0.9226
71029408|NCT03561883|141566701|SUPERIORITY||Difference in Responder Rate|1.3|||||TWO_SIDED|95.0|-6.9|9.5|||||95% confidence interval (CI) for Difference in Responder Rates is obtained using the Newcombe CI.|||9.5|-6.9|
71029409|NCT03561883|141566701|SUPERIORITY||Odds Ratio (OR)|1.06||||0.7424|TWO_SIDED|95.0|0.76|1.48|||Cochran-Mantel-Haenszel||Odds Ratio for Response (IW-3718 : placebo)|Treatment difference was calculated as the difference in the responder rates at Week 8; IW-3718 - placebo. The 95% CI for the difference in the responder rates was obtained using the Newcombe CI. P value was based on the odds ratio for the response rate (IW-3718:placebo) obtained from the Cochran-Mantel-Haenszel (CMH) tests controlling for baseline esophagitis status and baseline heartburn severity level (\< 3 vs. ≥ 3).||1.48|0.76|0.7424
71029410|NCT03561883|141566702|SUPERIORITY||Difference in Proportion Ratio|1.171||||0.4164|TWO_SIDED|95.0|0.8|1.714||Negative binomial model was used to deal with data overdispersion.|Negative binomial model||Difference in Proportion Ratio, (1500 mg IW-3718 BID + PPI) - (Placebo + PPI)|Poisson regression including the fixed categorical effect of treatment, the baseline esophagitis status (present vs. not present) and baseline WHSS (\<3 vs. ≥3), the covariate of baseline proportion of heartburn-free days, and with the diary entry duration (in days) as a weight variable adjusted in the model was applied.||1.714|0.800|0.4164
71015710|NCT01976104|141539032|SUPERIORITY||Difference of proportion versus placebo|54.6|||<|0.0001|TWO_SIDED|95.0|36.5|72.7|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the scheduled procedure within each Baseline platelet count cohort|Difference of proportion vs placebo = proportion of Responders for avatrombopag - proportion of Responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the 60 mg avatrombopag and matched placebo treatment groups.||72.7|36.5|<0.0001
71015711|NCT01976104|141539033|SUPERIORITY||Difference of proportion versus placebo|60.2|||<|0.0001|TWO_SIDED|95.0|46.8|73.5|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the scheduled procedure within each Baseline platelet count cohort.|Difference of proportion vs placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the avatrombopag and placebo treatment groups.||73.5|46.8|<0.0001
71015712|NCT01976104|141539033|SUPERIORITY||Difference of proportion versus placebo|53.7|||<|0.0001|TWO_SIDED|95.0|35.8|71.6|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the scheduled procedure within each Baseline platelet count cohort.|Difference of proportion vs placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the avatrombopag and placebo treatment groups||71.6|35.8|<0.0001
71015713|NCT01976104|141539034|SUPERIORITY||Difference in change of platelet count|25.4|||<|0.0001|TWO_SIDED|95.0|19.5|32.0|||Wilcoxon Rank Sum Test|P-value was based on Wilcoxon Rank Sum Test for each avatrombopag treatment group versus placebo within each Baseline platelet count cohort.|Difference in change from Baseline of platelet count for avatrombopag versus placebo within each Baseline platelet count cohort was based on Hodges-Lehmann estimation; 95% CI was the asymptotic (Moses) CI|||32.0|19.5|<0.0001
71015714|NCT01976104|141539034|SUPERIORITY||Difference in change of platelet count|36.3|||<|0.0001|TWO_SIDED|95.0|25.5|45.5|||Wilcoxon Rank Sum Test|P-value was based on Wilcoxon Rank Sum Test for each avatrombopag treatment group versus placebo within each Baseline platelet count cohort.|Difference in change from baseline of platelet count for avatrombopag vs. placebo within each baseline platelet count cohort is based on Hodges-Lehmann estimation; 95% confidence interval is the asymptotic (Moses) CI.|||45.5|25.5|<0.0001
71015715|NCT01353209|141539042|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|Linear Mixed-Effects Model Adjusted for Sirolimus Use||||||0.4
71015716|NCT01353209|141539043|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|Linear Mixed-Effects Model Adjusted for Sirolimus Use||||||0.7
71104690|NCT01098747|141716674|SUPERIORITY_OR_OTHER||Difference in proportion|21.25|||<|0.001|TWO_SIDED|95.0|9.58|32.92||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||32.92|9.58|<0.001
71015717|NCT01353209|141539044|SUPERIORITY|||||||0.8|||||||Regression, Linear|Linear Mixed-Effects Model Adjusted for Sirolimus Use||||||0.8
71015718|NCT01353209|141539044|SUPERIORITY|||||||0.8|||||||Regression, Linear|||||||.8
71015719|NCT01353209|141539045|SUPERIORITY|||||||0.015|||||||Mixed Models Analysis|Linear Mixed-Effects Model Adjusted for Sirolimus Use. P value was obtained for testing zero slope for log(VEGF-D).||||||0.015
71015720|NCT02951182|141539047|SUPERIORITY||Least Squares (LS) Mean Difference|8.6||||0.0016|TWO_SIDED|95.0|3.5|13.8|||Mixed-effects Model for Repeated Measure|||||13.8|3.5|0.0016
71015721|NCT02951182|141539047|SUPERIORITY||Least Squares (LS) Mean Difference|10.6||||0.0001|TWO_SIDED|95.0|5.5|15.8|||Mixed-effects Model for Repeated Measure|||||15.8|5.5|0.0001
71104691|NCT01098747|141716674|SUPERIORITY_OR_OTHER||Difference in proportion|72.65|||<|0.001|TWO_SIDED|95.0|61.59|83.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.71|61.59|<0.001
71015722|NCT02951182|141539047|SUPERIORITY||Least Squares (LS) Mean Difference|12.0||||0.0001|TWO_SIDED|95.0|6.7|17.4|||Mixed-effects Model for Repeated Measure|||||17.4|6.7|0.0001
71015723|NCT02951182|141539048|SUPERIORITY||Least Squares (LS) Mean Difference|-22.3|||||TWO_SIDED|95.0|-32.1|-12.4||||||||-12.4|-32.1|
71015724|NCT02951182|141539048|SUPERIORITY||Least Squares (LS) Mean Difference|-34.7|||||TWO_SIDED|95.0|-44.7|-24.8||||||||-24.8|-44.7|
71015725|NCT02951182|141539048|SUPERIORITY||Least Squares (LS) Mean Difference|-33.4|||||TWO_SIDED|95.0|-48.5|-18.3||||||||-18.3|-48.5|
71015726|NCT02951182|141539049|SUPERIORITY||Least Squares (LS) Mean Difference|14.8|||||TWO_SIDED|95.0|5.3|24.2||||||||24.2|5.3|
71015727|NCT02951182|141539049|SUPERIORITY||Least Squares (LS) Mean Difference|19.1|||||TWO_SIDED|95.0|9.7|28.6||||||||28.6|9.7|
71015728|NCT02951182|141539049|SUPERIORITY||Least Squares (LS) Mean Difference|20.0|||||TWO_SIDED|95.0|10.8|29.1||||||||29.1|10.8|
71015729|NCT02951182|141539050|SUPERIORITY||Least Squares (LS) Mean Difference|16.1|||||TWO_SIDED|95.0|5.4|26.8||||||||26.8|5.4|
71015730|NCT02951182|141539050|SUPERIORITY||Least Squares (LS) Mean Difference|18.5|||||TWO_SIDED|95.0|7.9|29.1||||||||29.1|7.9|
71015731|NCT02951182|141539050|SUPERIORITY||Least Squares (LS) Mean Difference|20.2|||||TWO_SIDED|95.0|11.9|28.4||||||||28.4|11.9|
71015732|NCT01335620|141539055|SUPERIORITY|||||||0.018|||||||Regression, Logistic|||Compare baseline to 24 weeks||||0.018
71015733|NCT03112720|141539058|OTHER||Odds Ratio (OR)|1.5|||<|0.01|TWO_SIDED||||||Chi-squared||||\< 0.01 study terminated because of covid and no meaningfull numbers participated|||<0.01
71015734|NCT03237325|141539146|SUPERIORITY|||||||0.1798|||||||Log Rank|||||||0.1798
71015735|NCT02684370|141539147|OTHER||adjusted difference in percentage|70.3|||<|0.001|TWO_SIDED|95.0|64.0|76.7||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||76.7|64.0|<0.001
71015736|NCT02684370|141539148|OTHER||adjusted difference in percentage|79.9|||<|0.001|TWO_SIDED|95.0|73.5|86.3||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||86.3|73.5|<0.001
71015737|NCT02684370|141539149|OTHER||adjusted difference in percentage|34.7|||<|0.001|TWO_SIDED|95.0|28.6|40.8||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||40.8|28.6|<0.001
71049789|NCT02504671|141606192|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||CDAI, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71104692|NCT01098747|141716674|SUPERIORITY_OR_OTHER||Difference in proportion|17.44||||0.001|TWO_SIDED|95.0|7.83|27.06||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||27.06|7.83|0.001
71104693|NCT01098747|141716674|SUPERIORITY_OR_OTHER||Difference in proportion|72.63|||<|0.001|TWO_SIDED|95.0|61.14|84.11||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.11|61.14|<0.001
71104694|NCT01098747|141716674|SUPERIORITY_OR_OTHER||Difference in proportion|11.7||||0.013|TWO_SIDED|95.0|3.47|19.93||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||19.93|3.47|0.013
71104695|NCT01098747|141716674|SUPERIORITY_OR_OTHER||Difference in proportion|73.58|||<|0.001|TWO_SIDED|95.0|61.83|85.33||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.33|61.83|<0.001
71104696|NCT01098747|141716674|SUPERIORITY_OR_OTHER||Difference in proportion|8.01||||0.041|TWO_SIDED|95.0|1.27|14.75||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.75|1.27|0.041
71049790|NCT02504671|141606192|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049791|NCT02504671|141606192|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049792|NCT02504671|141606192|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71049793|NCT02504671|141606192|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71049794|NCT02504671|141606192|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049795|NCT02504671|141606192|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71049796|NCT02504671|141606192|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049797|NCT02504671|141606192|OTHER||Difference|16.2|||||TWO_SIDED|95.0|4.3|28.1|||||CDAI, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|4.3|
71049798|NCT02504671|141606192|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71049799|NCT02504671|141606193|OTHER||Mean Difference (Net)|-4.09||||0.05|TWO_SIDED|95.0|-8.18|0.0||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, SDAI|||0.00|-8.18|0.050
70930160|NCT02510235|141358368|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.8596|TWO_SIDED|95.0|-0.78|0.87|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Study Eye analytic statistic is presented. The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.87|-0.78|0.8596
70930161|NCT02510235|141358369|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.7891|TWO_SIDED|95.0|-0.16|0.2|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Eyelid - Meibomian glands in Study eye analytic statistic is presented. The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.20|-0.16|0.7891
71049800|NCT02504671|141606193|OTHER||Mean Difference (Net)|-3.66||||0.086|TWO_SIDED|95.0|-7.84|0.52||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,SDAI|||0.52|-7.84|0.086
71049801|NCT02504671|141606193|OTHER||Mean Difference (Net)|-4.33||||0.038|TWO_SIDED|95.0|-8.43|-0.23||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,SDAI|||-0.23|-8.43|0.038
71049802|NCT02504671|141606193|OTHER||Mean Difference (Net)|-4.06||||0.119|TWO_SIDED|95.0|-9.18|1.05||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,SDAI|||1.05|-9.18|0.119
71049803|NCT02504671|141606193|OTHER||Mean Difference (Net)|-4.72||||0.071|TWO_SIDED|95.0|-9.85|0.4||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,SDAI|||0.40|-9.85|0.071
71049804|NCT02504671|141606193|OTHER||Mean Difference (Net)|-5.48||||0.034|TWO_SIDED|95.0|-10.53|-0.42||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,SDAI|||-0.42|-10.53|0.034
71049805|NCT02504671|141606193|OTHER||Mean Difference (Net)|-6.78||||0.023|TWO_SIDED|95.0|-12.61|-0.94||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,SDAI|||-0.94|-12.61|0.023
71049806|NCT02504671|141606193|OTHER||Mean Difference (Net)|-7.28||||0.014|TWO_SIDED|95.0|-13.09|-1.47||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,SDAI|||-1.47|-13.09|0.014
71049807|NCT02504671|141606193|OTHER||Mean Difference (Net)|-9.23||||0.002|TWO_SIDED|95.0|-14.99|-3.47||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,SDAI|||-3.47|-14.99|0.002
71049808|NCT02504671|141606193|OTHER||Mean Difference (Net)|-5.65||||0.063|TWO_SIDED|95.0|-11.62|0.32||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,SDAI|||0.32|-11.62|0.063
71049809|NCT02504671|141606193|OTHER||Mean Difference (Net)|-6.29||||0.04|TWO_SIDED|95.0|-12.28|-0.3||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,SDAI|||-0.30|-12.28|0.040
71049810|NCT02504671|141606193|OTHER||Mean Difference (Net)|-6.79||||0.024|TWO_SIDED|95.0|-12.69|-0.9||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,SDAI|||-0.90|-12.69|0.024
71049811|NCT02504671|141606193|OTHER||Mean Difference (Net)|-6.58||||0.05|TWO_SIDED|95.0|-13.15|-0.01||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,SDAI|||-0.01|-13.15|0.050
71049812|NCT02504671|141606193|OTHER||Mean Difference (Net)|-9.15||||0.006|TWO_SIDED|95.0|-15.71|-2.6||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,SDAI|||-2.60|-15.71|0.006
71049813|NCT02504671|141606193|OTHER||Mean Difference (Net)|-8.86||||0.007|TWO_SIDED|95.0|-15.32|-2.41||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,SDAI|||-2.41|-15.32|0.007
71049814|NCT02504671|141606193|OTHER||Mean Difference (Net)|-6.91||||0.074|TWO_SIDED|95.0|-14.49|0.68||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,SDAI|||0.68|-14.49|0.074
71049815|NCT02504671|141606193|OTHER||Mean Difference (Net)|-10.37||||0.008|TWO_SIDED|95.0|-17.99|-2.74||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,SDAI|||-2.74|-17.99|0.008
71049816|NCT02504671|141606193|OTHER||Mean Difference (Net)|-14.15|||<|0.001|TWO_SIDED|95.0|-21.64|-6.67||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,SDAI|||-6.67|-21.64|<0.001
71049817|NCT02504671|141606193|OTHER||Mean Difference (Net)|-1.88||||0.656|TWO_SIDED|95.0|-10.19|6.43||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,SDAI|||6.43|-10.19|0.656
71049818|NCT02504671|141606193|OTHER||Mean Difference (Net)|-7.0||||0.093|TWO_SIDED|95.0|-15.19|1.19||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,SDAI|||1.19|-15.19|0.093
70930162|NCT02510235|141358369|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.6075|TWO_SIDED|95.0|-0.24|0.14|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Eyelid - Erythema in Study eye analytic statistic is presented. The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.14|-0.24|0.6075
70930163|NCT02510235|141358369|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.6639|TWO_SIDED|95.0|-0.14|0.21|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Eyelid - Oedema in Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.21|-0.14|0.6639
71015738|NCT02684370|141539150|OTHER||adjusted difference in percentage|35.5|||<|0.001|TWO_SIDED|95.0|30.0|41.0||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||41.0|30.0|< 0.001
71049819|NCT02504671|141606193|OTHER||Mean Difference (Net)|-7.26||||0.076|TWO_SIDED|95.0|-15.3|0.78||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,SDAI|||0.78|-15.30|0.076
71049820|NCT02504671|141606193|OTHER||Mean Difference (Net)|0.8||||0.86|TWO_SIDED|95.0|-8.14|9.74||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,SDAI|||9.74|-8.14|0.860
71049821|NCT02504671|141606193|OTHER||Mean Difference (Net)|-5.71||||0.196|TWO_SIDED|95.0|-14.4|2.99||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,SDAI|||2.99|-14.40|0.196
71049822|NCT02504671|141606193|OTHER||Mean Difference (Net)|-6.0||||0.164|TWO_SIDED|95.0|-14.48|2.48||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,SDAI|||2.48|-14.48|0.164
71049823|NCT02504671|141606193|OTHER||Mean Difference (Net)|-10.65||||0.066|TWO_SIDED|95.0|-21.99|0.69||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,SDAI|||0.69|-21.99|0.066
71049824|NCT02504671|141606193|OTHER||Mean Difference (Net)|-16.37||||0.003|TWO_SIDED|95.0|-27.25|-5.49||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,SDAI|||-5.49|-27.25|0.003
71049825|NCT02504671|141606193|OTHER||Mean Difference (Net)|-15.67||||0.004|TWO_SIDED|95.0|-26.3|-5.03||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,SDAI|||-5.03|-26.30|0.004
71049826|NCT02504671|141606193|OTHER||Mean Difference (Net)|-4.78||||0.024|TWO_SIDED|95.0|-8.91|-0.65||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,SDAI|||-0.65|-8.91|0.024
71049827|NCT02504671|141606193|OTHER||Mean Difference (Net)|-7.77|||<|0.001|TWO_SIDED|95.0|-11.84|-3.7||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,SDAI|||-3.70|-11.84|<0.001
71049828|NCT02504671|141606193|OTHER||Mean Difference (Net)|-6.67||||0.01|TWO_SIDED|95.0|-11.74|-1.6||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,SDAI|||-1.60|-11.74|0.010
71049829|NCT02504671|141606193|OTHER||Mean Difference (Net)|-6.85||||0.008|TWO_SIDED|95.0|-11.91|-1.78||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,SDAI|||-1.78|-11.91|0.008
71049830|NCT02504671|141606193|OTHER||Mean Difference (Net)|-8.44||||0.004|TWO_SIDED|95.0|-14.2|-2.67||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,SDAI|||-2.67|-14.20|0.004
71049831|NCT02504671|141606193|OTHER||Mean Difference (Net)|-12.51|||<|0.001|TWO_SIDED|95.0|-18.26|-6.75||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,SDAI|||-6.75|-18.26|<0.001
71049832|NCT02504671|141606193|OTHER||Mean Difference (Net)|-7.0||||0.022|TWO_SIDED|95.0|-12.99|-1.01||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,SDAI|||-1.01|-12.99|0.022
71049833|NCT02504671|141606193|OTHER||Mean Difference (Net)|-10.16|||<|0.001|TWO_SIDED|95.0|-16.07|-4.24||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,SDAI|||-4.24|-16.07|<0.001
71049834|NCT02504671|141606193|OTHER||Mean Difference (Net)|-11.18|||<|0.001|TWO_SIDED|95.0|-17.7|-4.66||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,SDAI|||-4.66|-17.70|<0.001
71049835|NCT02504671|141606193|OTHER||Mean Difference (Net)|-14.0|||<|0.001|TWO_SIDED|95.0|-20.57|-7.44||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,SDAI|||-7.44|-20.57|<0.001
71049836|NCT02504671|141606193|OTHER||Mean Difference (Net)|-9.68||||0.013|TWO_SIDED|95.0|-17.26|-2.11||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,SDAI|||-2.11|-17.26|0.013
71049837|NCT02504671|141606193|OTHER||Mean Difference (Net)|-16.86|||<|0.001|TWO_SIDED|95.0|-24.39|-9.32||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,SDAI|||-9.32|-24.39|<0.001
70930164|NCT02510235|141358369|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.3482|TWO_SIDED|95.0|-0.1|0.29|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Conjunctiva - Erythema in Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value is not duplicated or triplicated, reflecting the global outcome consistent with repeated measures ANOVA methodology.||0.29|-0.10|0.3482
70930165|NCT02510235|141358369|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.2422|TWO_SIDED|95.0|-0.34|0.09|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Conjunctiva - Oedema in Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline (Visit 2 - Day 1) across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.09|-0.34|0.2422
71015739|NCT02684370|141539151|OTHER||adjusted difference in percentage|57.9|||<|0.001|TWO_SIDED|95.0|50.4|65.3||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||65.3|50.4|< 0.001
71015740|NCT02684370|141539152|OTHER||adjusted difference in percentage|27.1|||<|0.001|TWO_SIDED|95.0|21.2|32.9||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||32.9|21.2|< 0.001
71015741|NCT02684370|141539153|OTHER||adjusted difference in percentage|33.5|||<|0.001|TWO_SIDED|95.0|22.7|44.3||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||44.3|22.7|< 0.001
71015742|NCT02684370|141539154|OTHER||adjusted difference in percentage|25.1|||<|0.001|TWO_SIDED|95.0|15.2|35.0||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||35.0|15.2|< 0.001
71104697|NCT01098747|141716674|SUPERIORITY_OR_OTHER||Difference in proportion|73.58|||<|0.001|TWO_SIDED|95.0|61.83|85.33||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.33|61.83|<0.001
71104698|NCT01098747|141716674|SUPERIORITY_OR_OTHER||Difference in proportion|6.79||||0.073|TWO_SIDED|95.0|0.23|13.36||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.36|0.23|0.073
71104699|NCT01098747|141716674|SUPERIORITY_OR_OTHER||Difference in proportion|73.58|||<|0.001|TWO_SIDED|95.0|61.83|85.33||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.33|61.83|<0.001
71015743|NCT02684370|141539155|OTHER||adjusted difference in percentage|23.8|||<|0.001|TWO_SIDED|95.0|15.5|32.1||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||32.1|15.5|< 0.001
71015744|NCT02684370|141539156|OTHER||adjusted difference in percentage|22.9|||<|0.001|TWO_SIDED|95.0|14.3|31.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||31.6|14.3|< 0.001
71049838|NCT02504671|141606193|OTHER||Mean Difference (Net)|-6.03||||0.149|TWO_SIDED|95.0|-14.24|2.18||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,SDAI|||2.18|-14.24|0.149
71049839|NCT02504671|141606193|OTHER||Mean Difference (Net)|-9.43||||0.019|TWO_SIDED|95.0|-17.32|-1.55||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,SDAI|||-1.55|-17.32|0.019
71049840|NCT02504671|141606193|OTHER||Mean Difference (Net)|-6.59||||0.138|TWO_SIDED|95.0|-15.32|2.14||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,SDAI|||2.14|-15.32|0.138
71049841|NCT02504671|141606193|OTHER||Mean Difference (Net)|-8.7||||0.04|TWO_SIDED|95.0|-16.99|-0.42||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,SDAI|||-0.42|-16.99|0.040
71049842|NCT02504671|141606193|OTHER||Mean Difference (Net)|-15.88||||0.005|TWO_SIDED|95.0|-26.77|-4.98||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,SDAI|||-4.98|-26.77|0.005
71049843|NCT02504671|141606193|OTHER||Mean Difference (Net)|-20.87|||<|0.001|TWO_SIDED|95.0|-31.2|-10.53||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,SDAI|||-10.53|-31.20|<0.001
71049844|NCT02504671|141606194|OTHER||Mean Difference (Net)|-3.84||||0.063|TWO_SIDED|95.0|-7.89|0.2||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,CDAI|||0.20|-7.89|0.063
71104700|NCT01098747|141716674|SUPERIORITY_OR_OTHER||Difference in proportion|6.79||||0.073|TWO_SIDED|95.0|0.23|13.36||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.36|0.23|0.073
71104701|NCT01098747|141716674|SUPERIORITY_OR_OTHER||Difference in proportion|73.58|||<|0.001|TWO_SIDED|95.0|61.83|85.33||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.33|61.83|<0.001
71104702|NCT01098747|141716674|SUPERIORITY_OR_OTHER||Difference in proportion|6.79||||0.073|TWO_SIDED|95.0|0.23|13.36||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.36|0.23|0.073
71049845|NCT02504671|141606194|OTHER||Mean Difference (Net)|-3.84||||0.067|TWO_SIDED|95.0|-7.95|0.28||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,CDAI|||0.28|-7.95|0.067
71049846|NCT02504671|141606194|OTHER||Mean Difference (Net)|-4.43||||0.032|TWO_SIDED|95.0|-8.46|-0.39||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,CDAI|||-0.39|-8.46|0.032
71049847|NCT02504671|141606194|OTHER||Mean Difference (Net)|-4.17||||0.102|TWO_SIDED|95.0|-9.17|0.84||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,CDAI|||0.84|-9.17|0.102
71049848|NCT02504671|141606194|OTHER||Mean Difference (Net)|-3.47||||0.17|TWO_SIDED|95.0|-8.43|1.49||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,CDAI|||1.49|-8.43|0.170
71049849|NCT02504671|141606194|OTHER||Mean Difference (Net)|-5.2||||0.039|TWO_SIDED|95.0|-10.13|-0.27||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,CDAI|||-0.27|-10.13|0.039
71049850|NCT02504671|141606194|OTHER||Mean Difference (Net)|-7.2||||0.012|TWO_SIDED|95.0|-12.82|-1.57||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,CDAI|||-1.57|-12.82|0.012
71049851|NCT02504671|141606194|OTHER||Mean Difference (Net)|-6.73||||0.018|TWO_SIDED|95.0|-12.3|-1.16||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,CDAI|||-1.16|-12.30|0.018
71049852|NCT02504671|141606194|OTHER||Mean Difference (Net)|-9.19||||0.001|TWO_SIDED|95.0|-14.73|-3.66||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,CDAI|||-3.66|-14.73|0.001
71049853|NCT02504671|141606194|OTHER||Mean Difference (Net)|-5.48||||0.065|TWO_SIDED|95.0|-11.31|0.35||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,CDAI|||0.35|-11.31|0.065
71049854|NCT02504671|141606194|OTHER||Mean Difference (Net)|-5.85||||0.05|TWO_SIDED|95.0|-11.69|0.0||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,CDAI|||-0.00|-11.69|0.050
71015745|NCT02684370|141539157|OTHER||adjusted difference in percentage|38.3|||<|0.001|TWO_SIDED|95.0|27.9|48.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||48.6|27.9|< 0.001
70930166|NCT02510235|141358369|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.8645|TWO_SIDED|95.0|-0.11|0.14|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Lens in Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.14|-0.11|0.8645
71015746|NCT02684370|141539158|OTHER||adjusted difference in percentage|35.1|||<|0.001|TWO_SIDED|95.0|25.7|44.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||44.6|25.7|< 0.001
71015747|NCT02684370|141539159|OTHER||adjusted difference in percentage|36.5|||<|0.001|TWO_SIDED|95.0|27.0|45.9||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||45.9|27.0|< 0.001
71015748|NCT02684370|141539160|OTHER||adjusted difference in percentage|17.0|||<|0.001|TWO_SIDED|95.0|7.4|26.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||26.6|7.4|< 0.001
71015749|NCT02684370|141539161|OTHER||adjusted difference in percentage|17.3|||<|0.001|TWO_SIDED|95.0|7.3|27.3||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||27.3|7.3|< 0.001
71015750|NCT02684370|141539162|OTHER||adjusted difference in percentage|23.0|||<|0.001|TWO_SIDED|95.0|11.9|34.0||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||34.0|11.9|< 0.001
71049855|NCT02504671|141606194|OTHER||Mean Difference (Final Values)|-6.63||||0.024|TWO_SIDED|95.0|-12.38|-0.87||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,CDAI|||-0.87|-12.38|0.024
71049856|NCT02504671|141606194|OTHER||Mean Difference (Net)|-6.41||||0.051|TWO_SIDED|95.0|-12.84|0.02||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,CDAI|||0.02|-12.84|0.051
71049857|NCT02504671|141606194|OTHER||Mean Difference (Net)|-8.6||||0.008|TWO_SIDED|95.0|-14.97|-2.22||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,CDAI|||-2.22|-14.97|0.008
71049858|NCT02504671|141606194|OTHER||Mean Difference (Net)|-8.74||||0.007|TWO_SIDED|95.0|-15.06|-2.43||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,CDAI|||-2.43|-15.06|0.007
71049859|NCT02504671|141606194|OTHER||Mean Difference (Net)|-6.8||||0.071|TWO_SIDED|95.0|-14.19|0.58||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,CDAI|||0.58|-14.19|0.071
71049860|NCT02504671|141606194|OTHER||Mean Difference (Net)|-9.8||||0.009|TWO_SIDED|95.0|-17.17|-2.44||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,CDAI|||-2.44|-17.17|0.009
71049861|NCT02504671|141606194|OTHER||Mean Difference (Net)|-13.88|||<|0.001|TWO_SIDED|95.0|-21.17|-6.59||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,CDAI|||-6.59|-21.17|<0.001
71049862|NCT02504671|141606194|OTHER||Mean Difference (Net)|-1.68||||0.676|TWO_SIDED|95.0|-9.63|6.26||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,CDAI|||6.26|-9.63|0.676
71049863|NCT02504671|141606194|OTHER||Mean Difference (Net)|-6.33||||0.11|TWO_SIDED|95.0|-14.11|1.44||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,CDAI|||1.44|-14.11|0.110
71104703|NCT01098747|141716674|SUPERIORITY_OR_OTHER||Difference in proportion|74.71|||<|0.001|TWO_SIDED|95.0|63.14|86.27||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.27|63.14|<0.001
71104704|NCT01098747|141716674|SUPERIORITY_OR_OTHER||Difference in proportion|7.84||||0.035|TWO_SIDED|95.0|1.57|14.1||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.10|1.57|0.035
71104705|NCT01098747|141716674|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
71104706|NCT01098747|141716674|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
71104707|NCT01098747|141716675|SUPERIORITY_OR_OTHER||Difference in proportion|20.01||||0.004|TWO_SIDED|95.0|8.79|31.24||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||31.24|8.79|0.004
71104708|NCT01098747|141716675|SUPERIORITY_OR_OTHER||Difference in proportion|14.35||||0.003|TWO_SIDED|95.0|4.26|24.43||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||24.43|4.26|0.003
71104709|NCT01098747|141716675|SUPERIORITY_OR_OTHER||Difference in proportion|69.53|||<|0.001|TWO_SIDED|95.0|57.67|81.4||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.40|57.67|<0.001
71049864|NCT02504671|141606194|OTHER||Mean Difference (Net)|-6.44||||0.099|TWO_SIDED|95.0|-14.12|1.23||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,CDAI|||1.23|-14.12|0.099
71049865|NCT02504671|141606194|OTHER||Mean Difference (Net)|1.04||||0.812|TWO_SIDED|95.0|-7.61|9.69||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,CDAI|||9.69|-7.61|0.812
71104710|NCT01098747|141716675|SUPERIORITY_OR_OTHER||Difference in proportion|23.45|||<|0.001|TWO_SIDED|95.0|13.16|33.75||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||33.75|13.16|<0.001
71104711|NCT01098747|141716675|SUPERIORITY_OR_OTHER||Difference in proportion|73.72|||<|0.001|TWO_SIDED|95.0|62.77|84.67||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.67|62.77|<0.001
71104712|NCT01098747|141716675|SUPERIORITY_OR_OTHER||Difference in proportion|10.14||||0.014|TWO_SIDED|95.0|3.21|17.08||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.08|3.21|0.014
71104713|NCT01098747|141716675|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
71049866|NCT02504671|141606194|OTHER||Mean Difference (Net)|-5.39||||0.204|TWO_SIDED|95.0|-13.75|2.96||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,CDAI|||2.96|-13.75|0.204
71049867|NCT02504671|141606194|OTHER||Mean Difference (Net)|-5.9||||0.157|TWO_SIDED|95.0|-14.09|2.3||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,CDAI|||2.30|-14.09|0.157
71049868|NCT02504671|141606194|OTHER||Mean Difference (Net)|-9.37||||0.088|TWO_SIDED|95.0|-20.15|1.42||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,CDAI|||1.42|-20.15|0.088
70930167|NCT02510235|141358369|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.379|TWO_SIDED|95.0|-0.11|0.04|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Cornea transparency in Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.04|-0.11|0.3790
70930168|NCT02510235|141358370|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.8363|TWO_SIDED|95.0|-0.26|0.21|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.21|-0.26|0.8363
71015751|NCT02684370|141539163|OTHER||Mean Difference (Final Values)|-5.765|||<|0.001|TWO_SIDED|95.0|-6.496|-5.035|||van Elteren test|||P-value calculated by the van Elteren test stratified for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||-5.035|-6.496|<0.001
71015752|NCT04221373|141539164|OTHER|Mixed-effects model|||||<|0.01||||||Main effect of time|Mixed Models Analysis|F(1, 26) = 117.78||SCIM Total Score||||<0.01
71015753|NCT04221373|141539164|OTHER|Mixed-effects model||||||0.03||||||treatment group by time interaction effects|Mixed Models Analysis|F(1,26) = 5.59||SCIM Total Score||||0.03
71015754|NCT04221373|141539164|OTHER|Mixed-effects model||||||0.01||||||treatment group by time interaction effects|Mixed Models Analysis|F(1,26) = 8.02||SCIM R \& S scores||||0.01
71015755|NCT04221373|141539164|OTHER|Mixed-effects model|||||<|0.01||||||Main effect of time|Mixed Models Analysis|F(1, 26) = 72.49||SCIM R \& S scores||||< 0.01
71015756|NCT04221373|141539165|OTHER|Mixed-effects model||||||0.02||||||Treatment group by time interaction effects|Mixed Models Analysis|F(1,26) = 5.82||LEMS||||0.02
71049869|NCT02504671|141606194|OTHER||Mean Difference (Net)|-15.12||||0.004|TWO_SIDED|95.0|-25.4|-4.83||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,CDAI|||-4.83|-25.40|0.004
71104714|NCT01098747|141716675|SUPERIORITY_OR_OTHER||Difference in proportion|8.35||||0.028|TWO_SIDED|95.0|2.02|14.68||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.68|2.02|0.028
71015757|NCT04221373|141539165|OTHER|Mixed-effects model|||||<|0.01||||||Main effect of time|Mixed Models Analysis|F(1, 26) = 33.29||LEMS||||<0.01
71015758|NCT04221373|141539165|OTHER|Mixed-effects model||||||0.04||||||Treatment group by time interaction effects|Mixed Models Analysis|F(1,26) = 4.58||UEMS||||0.04
71015759|NCT04221373|141539165|OTHER|Mixed-effects model|||||<|0.01||||||Main effect of time|Mixed Models Analysis|F(1, 26) = 15.34||UEMS||||<0.01
71015760|NCT04221373|141539165|OTHER|Mixed-effects model|||||<|0.01||||||Treatment group by time interaction effects|Mixed Models Analysis|F(1,26) = 8.06||TMS||||<0.01
71015761|NCT04221373|141539165|OTHER|TMS|||||<|0.01||||||Main effect of time|Mixed Models Analysis|F(1,26) = 38.91||||||<0.01
71015762|NCT04221373|141539165|OTHER|Mixed-effects model||||||0.02||||||Treatment group by time interaction effects|Mixed Models Analysis|F(1,21.7) = 6.23||TLTS||||0.02
71015763|NCT04221373|141539165|OTHER|Mixed-effects model||||||0.05||||||Main effect of time|Mixed Models Analysis|F(1 26)=4.14||TLTS||||0.05
71015764|NCT04221373|141539166|OTHER|Mixed-effects model||||||0.485||||||Treatment group-by-time interaction effect|Mixed Models Analysis|F(1, 21) = 0.51||Average worst pain intensity||||0.485
71015765|NCT04221373|141539166|OTHER|Mixed-effects model||||||0||||||Main effect of time|Mixed Models Analysis|F(1, 21) = 26.71||Average worst pain intensity||||0.000
71015766|NCT04221373|141539166|OTHER|Mixed-effects model||||||0.832||||||Treatment group-by-time interaction effect|Mixed Models Analysis|F(1, 21) = 0.05||Worst pain interference with day-to-day activities||||0.832
71015767|NCT04221373|141539166|OTHER|Mixed-effects model||||||0.033||||||Main effect of time|Mixed Models Analysis|F(1, 21) = 5.21||Worst pain interference with day-to-day activities||||0.033
71015768|NCT04221373|141539166|OTHER|Mixed-effects model||||||0.692||||||Treatment group-by-time interaction effect|Mixed Models Analysis|F(1, 42) = 0.16||Worst pain interference with overall mood||||0.692
71015769|NCT04221373|141539166|OTHER|Mixed-effects model||||||0.005||||||Main effect of time|Mixed Models Analysis|F(1, 42) = 8.65||Worst pain interference with overall mood||||0.005
71015770|NCT04221373|141539166|OTHER|Mixed-effects model||||||0.946||||||Treatment group-by-time interaction effect|Mixed Models Analysis|F(1,21) = 0.01||Worst pain interfered with sleep||||0.946
71015771|NCT04221373|141539166|OTHER|Mixed-effects model||||||0.0002||||||Main effect of time|Mixed Models Analysis|F(1,21) = 11.94||Worst pain interference with sleep||||0.0002
71015772|NCT04221373|141539167|SUPERIORITY|||||||0.554|||||||Chi-squared|X\^2 (1, N = 23) = 0.35||Baseline||||0.554
71049870|NCT02504671|141606194|OTHER||Mean Difference (Net)|-14.91||||0.004|TWO_SIDED|95.0|-25.01|-4.8||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,CDAI|||-4.80|-25.01|0.004
71049871|NCT02504671|141606194|OTHER||Mean Difference (Net)|-3.89||||0.06|TWO_SIDED|95.0|-7.96|0.17||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,CDAI|||0.17|-7.96|0.060
70930169|NCT02510235|141358371|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.6248|TWO_SIDED|95.0|-0.62|1.02|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline (Visit 2 - Day 1) across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||1.02|-0.62|0.6248
71104715|NCT01098747|141716675|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
71104716|NCT01098747|141716675|SUPERIORITY_OR_OTHER||Difference in proportion|7.81||||0.036|TWO_SIDED|95.0|1.54|14.08||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.08|1.54|0.036
71015773|NCT04221373|141539167|SUPERIORITY|||||||0.949|||||||Chi-squared|X\^2 (1, N = 23) = 0.004||discharge from acute inpatient rehabilitation (average 2-3 weeks)||||0.949
71015774|NCT01828164|141539186|SUPERIORITY_OR_OTHER||Percent Change|29.0||||0.0164|TWO_SIDED||||||t-test, 1 sided||Percent change in tooth movement rate on the treatment side as compared to the control side.|||||0.0164
71015775|NCT01828164|141539187|SUPERIORITY_OR_OTHER||Percent change|220.8||||0.0423|TWO_SIDED||||||t-test, 1 sided||Percent change in root resorption rate on the control side as compared to the treatment side.|||||0.0423
71015776|NCT01828164|141539188|NON_INFERIORITY|1 point on the 10-point pain scale was used as the non-inferiority margin.|||||<|0.001|||||||Bootstrapped mean difference|This test bootstrapped the mean difference (Treatment Arm - Control Arm) less 1, the non-inferiority margin, 1000 times.||||||<0.001
71015777|NCT04983589|141539194|SUPERIORITY||Percentage Difference|27.3|||<|0.0001|TWO_SIDED|95.0|17.3|37.4||Analysis was done using chi-square test.|Chi-squared||The 95% confidence interval for the proportion differences was calculated using the normal approximation based on pooled variance without continuity correction.|||37.4|17.3|<0.0001
71015778|NCT04983589|141539195|SUPERIORITY||Percentage Difference|26.4|||<|0.0001|TWO_SIDED|95.0|16.8|36.0||Analysis was done using chi-square test.|Chi-squared||The 95% confidence interval for the proportion differences was calculated using the normal approximation based on pooled variance without continuity correction.|||36.0|16.8|<0.0001
71015779|NCT04983589|141539196|SUPERIORITY||Percentage Difference|34.7|||<|0.0001|TWO_SIDED|95.0|22.7|46.7||Analysis was done using chi-square test.|Chi-squared||The 95% confidence interval for the proportion differences was calculated based on the normal approximation using pooled variance without continuity correction.|||46.7|22.7|<0.0001
71015780|NCT04983589|141539197|SUPERIORITY||Percentage Difference|20.6||||0.001|TWO_SIDED|95.0|8.6|32.6||Analysis was done using chi-square test.|Chi-squared||The 95% confidence interval for the proportion differences was calculated using the normal approximation using pooled variance without continuity correction.|||32.6|8.6|0.001
71015781|NCT00761969|141539201|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Log Rank|||Survival, major-event-free survival and event-free survival of patients with PAD and control subjects was estimated by the Kaplan-Meier method and compared by the log-rank test. The numbers of non-fatal events and revascularization procedures (which could be more than one per person) were compared using the Poisson regression - the outcome being the number of events per person-year.||||<0.001
71015782|NCT00978120|141539204|SUPERIORITY_OR_OTHER|||||||0.014|||||||Fisher Exact|||||||0.014
71015783|NCT00978120|141539205|SUPERIORITY_OR_OTHER|||||||0.05|||||||Fisher Exact|||||||0.05
71015784|NCT00978120|141539208|SUPERIORITY_OR_OTHER|||||||0.47|||||||Fisher Exact|||||||0.470
71015785|NCT00978120|141539209|SUPERIORITY_OR_OTHER|||||||0.12|||||||Fisher Exact|||||||0.120
71104717|NCT01098747|141716675|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
71015786|NCT00978120|141539210|SUPERIORITY_OR_OTHER|||||||0.284|||||||Fisher Exact|||||||0.284
71015787|NCT00978120|141539211|SUPERIORITY_OR_OTHER|||||||0.004|||||||Fisher Exact|||||||0.004
71015788|NCT00978120|141539212|SUPERIORITY_OR_OTHER|||||||0.341|||||||Fisher Exact|||||||0.341
71015789|NCT00978120|141539213|SUPERIORITY_OR_OTHER|||||||0.02|||||||Fisher Exact|||||||0.020
71015790|NCT00978120|141539214|SUPERIORITY_OR_OTHER|||||||0.245|||||||Fisher Exact|||||||0.245
71015791|NCT00978120|141539215|SUPERIORITY_OR_OTHER|||||||0.173|||||||Fisher Exact|||||||0.173
71015792|NCT00978120|141539216|SUPERIORITY_OR_OTHER|||||||0.362|||||||Fisher Exact|||||||0.362
71015793|NCT00978120|141539217|SUPERIORITY_OR_OTHER|||||||0.006|||||||Fisher Exact|||||||0.006
71015794|NCT00978120|141539218|SUPERIORITY_OR_OTHER|||||||0.016|||||||Fisher Exact|||||||0.016
71015795|NCT00978120|141539219|SUPERIORITY_OR_OTHER|||||||0.032|||||||Fisher Exact|||||||0.032
71104718|NCT01098747|141716675|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
70930170|NCT02510235|141358372|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.6153|TWO_SIDED|95.0|-0.82|0.49|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline (Visit 2 - Day 1) across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.49|-0.82|0.6153
70930171|NCT03367156|141358382|OTHER||Mean Difference (Final Values)|0.0||||0.48|TWO_SIDED|95.0|-0.8|0.7|||Linear Model|||||0.7|-0.8|0.48
70930172|NCT03367156|141358383|OTHER||Mean Difference (Final Values)|0.2|||>|0.99|TWO_SIDED|95.0|-0.7|1.0|||Linear Model|||||1|-0.7|>0.99
70930173|NCT03367156|141358384|OTHER||Mean Difference (Final Values)|0.4||||0.97|TWO_SIDED|95.0|-0.7|1.6|||Linear Model|||||1.6|-0.7|0.97
71015796|NCT01068418|141539222|SUPERIORITY_OR_OTHER||||||<|0.05||||||Threshold for significance was P\<0.05.|Mixed Models Analysis|||A repeated measures regression analysis model was used to examine the effect of vitamin D3 therapy on the mean arterial pressure (mean of five measurements at each time point) before and during angiotensin II infusions, before and after vitamin D3 therapy.||||<0.05
70930174|NCT03367156|141358385|OTHER||Mean Difference (Final Values)|0.1||||0.78|TWO_SIDED|95.0|-0.8|1.0|||Linear Model|||||1.0|-0.8|0.78
70930175|NCT03367156|141358386|OTHER||Mean Difference (Final Values)|-0.5||||0.93|TWO_SIDED|95.0|-10.6|9.6|||Linear Model|||||9.6|-10.6|0.93
70930176|NCT03367156|141358387|OTHER||Mean Difference (Final Values)|0.6||||0.93|TWO_SIDED|95.0|-0.6|1.8|||Linear Model|||||1.8|-0.6|0.93
70930177|NCT03367156|141358388|OTHER||Mean Difference (Final Values)|0.1||||0.82|TWO_SIDED|95.0|-0.9|1.1|||Linear Model|||||1.1|-0.9|0.82
70930178|NCT03367156|141358389|OTHER||Mean Difference (Final Values)|-5.5||||0.38|TWO_SIDED|95.0|-17.9|6.9|||Linear Model|||||6.9|-17.9|0.38
70930179|NCT04084574|141358401|SUPERIORITY||Mean Difference (Net)|-4.9|STANDARD_DEVIATION|13.5||0.3968|TWO_SIDED|95.0|-16.8|6.9||The threshold for statistical significance is p = 0.05|t-test, 2 sided||Between group difference in mean blood pressure change from baseline for Standard of Care group minus Behavioral Diet Counseling group.|||6.9|-16.8|0.3968
71049872|NCT02504671|141606194|OTHER||Mean Difference (Net)|-7.39|||<|0.001|TWO_SIDED|95.0|-11.42|-3.36||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,CDAI|||-3.36|-11.42|<0.001
71049873|NCT02504671|141606194|OTHER||Mean Difference (Net)|-6.1||||0.016|TWO_SIDED|95.0|-11.06|-1.14||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,CDAI|||-1.14|-11.06|0.016
71049874|NCT02504671|141606194|OTHER||Mean Difference (Net)|-6.85||||0.007|TWO_SIDED|95.0|-11.78|-1.91||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,CDAI|||-1.91|-11.78|0.007
71049875|NCT02504671|141606194|OTHER||Mean Difference (Net)|-7.92||||0.005|TWO_SIDED|95.0|-13.48|-2.37||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,CDAI|||-2.37|-13.48|0.005
71049876|NCT02504671|141606194|OTHER||Mean Difference (Net)|-12.19|||<|0.001|TWO_SIDED|95.0|-17.74|-6.64||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,CDAI|||-6.64|-17.74|<0.001
71049877|NCT02504671|141606194|OTHER||Mean Difference (Net)|-5.62||||0.059|TWO_SIDED|95.0|-11.45|0.21||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,CDAI|||0.21|-11.45|0.059
71049878|NCT02504671|141606194|OTHER||Mean Difference (Net)|-10.17|||<|0.001|TWO_SIDED|95.0|-15.97|-4.38||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,CDAI|||-4.38|-15.97|<0.001
71049879|NCT02504671|141606194|OTHER||Mean Difference (Net)|-10.37||||0.002|TWO_SIDED|95.0|-16.75|-4.0||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,CDAI|||-4.00|-16.75|0.002
71049880|NCT02504671|141606194|OTHER||Mean Difference (Net)|-13.79|||<|0.001|TWO_SIDED|95.0|-20.18|-7.41||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,CDAI|||-7.41|-20.18|<0.001
71049881|NCT02504671|141606194|OTHER||Mean Difference (Net)|-9.67||||0.01|TWO_SIDED|95.0|-17.03|-2.31||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,CDAI|||-2.31|-17.03|0.010
71049882|NCT02504671|141606194|OTHER||Mean Difference (Net)|-16.63|||<|0.001|TWO_SIDED|95.0|-23.97|-9.3||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,CDAI|||-9.30|-23.97|<0.001
71049883|NCT02504671|141606194|OTHER||Mean Difference (Net)|-5.53||||0.165|TWO_SIDED|95.0|-13.37|2.3||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,CDAI|||2.30|-13.37|0.165
71049884|NCT02504671|141606194|OTHER||Mean Difference (Net)|-8.85||||0.022|TWO_SIDED|95.0|-16.39|-1.32||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,CDAI|||-1.32|-16.39|0.022
71049885|NCT02504671|141606194|OTHER||Mean Difference (Net)|-6.55||||0.127|TWO_SIDED|95.0|-14.99|1.89||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,CDAI|||1.89|-14.99|0.127
71049886|NCT02504671|141606194|OTHER||Mean Difference (Net)|-8.67||||0.034|TWO_SIDED|95.0|-16.67|-0.67||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,CDAI|||-0.67|-16.67|0.034
71015797|NCT01068418|141539223|SUPERIORITY_OR_OTHER||||||<|0.01||||||threshold for significance was P\<0.05.|Mixed Models Analysis|||A repeated measures regression analysis model was used to examine the effect of vitamin D3 therapy on the renal plasma flow (mean of three measurements at each time point) before and during angiotensin II infusions, before and after vitamin D3 therapy.||||<0.01
71104719|NCT01098747|141716675|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
71104720|NCT01098747|141716675|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
71104721|NCT01098747|141716675|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
71104722|NCT01098747|141716675|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
71015798|NCT02181673|141539230|SUPERIORITY_OR_OTHER||Percent Difference|53.4|||<|0.001|TWO_SIDED|95.0|45.8|60.9|||Cochran-Mantel-Haenszel|||||60.90|45.80|<0.001
71015799|NCT03155269|141539241|OTHER||Mean Difference (Final Values)|-0.0423||||0.1324|TWO_SIDED|97.5|-0.1057|0.0211||The setting of the two-sided significance level of 0.025 was used for the 2 co-primary endpoints to ensure that the overall significance level for the primary endpoint was less than or equal to 0.05.|ANCOVA|Analysis was performed using ANCOVA model with product group and strata as fixed effects, and the corresponding baseline value as covariate.|Difference is test product minus reference product such that a negative difference favors the test product.|||0.0211|-0.1057|0.1324
71015800|NCT03155269|141539242|OTHER||Mean Difference (Final Values)|0.229||||0.0469|TWO_SIDED|97.5|-0.03|0.489||The setting of the two-sided significance level of 0.025 was used for the 2 co-primary endpoints to ensure that the overall significance level for the primary endpoint was less than or equal to 0.05.|ANCOVA|Analysis was performed using ANCOVA model with product group and strata as fixed effects, and the corresponding baseline value as covariate.|Difference is test product minus reference product such that a negative difference favors the test product.|||0.489|-0.030|0.0469
71015801|NCT01354015|141539267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_DEVIATION|0.79||0.2539|TWO_SIDED|95.0|||||ANOVA|||All statistical analysis used intent-to-treat methodology and all comparisons used a two-tailed test at the .05 level of significance. Continuous variables are reported as means and standard deviations. W||||0.2539
71015802|NCT03733301|141539269|SUPERIORITY||Odds Ratio (OR)|1.88||||0.082|TWO_SIDED|95.0|0.92|3.85|||Regression, Logistic|||||3.85|0.92|0.082
71015803|NCT03733301|141539269|SUPERIORITY||Odds Ratio (OR)|2.77||||0.004|TWO_SIDED|95.0|1.38|5.56|||Regression, Logistic|||||5.56|1.38|0.004
71015804|NCT03733301|141539270|SUPERIORITY||Odds Ratio (OR)|2.62||||0.002|TWO_SIDED|95.0|1.44|4.76|||Regression, Logistic|||||4.76|1.44|0.002
71015805|NCT03733301|141539270|SUPERIORITY||Odds Ratio (OR)|3.27|||<|0.001|TWO_SIDED|95.0|1.8|5.97|||Regression, Logistic|||||5.97|1.80|< 0.001
71015806|NCT03733301|141539271|SUPERIORITY||Odds Ratio (OR)|1.24||||0.574|TWO_SIDED|95.0|0.59|2.62|||Regression, Logistic|||||2.62|0.59|0.574
71015807|NCT03733301|141539271|SUPERIORITY||Odds Ratio (OR)|2.07||||0.045|TWO_SIDED|95.0|1.02|4.2|||Regression, Logistic|||||4.20|1.02|0.045
71015808|NCT03733301|141539272|SUPERIORITY||Mean Difference (Final Values)|-13.08|STANDARD_ERROR_OF_MEAN|5.256||0.013|TWO_SIDED|95.0|-23.42|-2.73|||Mixed Models Analysis|||||-2.73|-23.42|0.013
71015809|NCT03733301|141539272|SUPERIORITY||Mean Difference (Final Values)|-22.13|STANDARD_ERROR_OF_MEAN|5.259|<|0.001|TWO_SIDED|95.0|-32.48|-11.78|||Mixed Models Analysis|||||-11.78|-32.48|<0.001
71015810|NCT03733301|141539273|SUPERIORITY||Odds Ratio (OR)|1.53||||0.364|TWO_SIDED|95.0|0.61|3.81|||Regression, Logistic|||||3.81|0.61|0.364
71015811|NCT03733301|141539273|SUPERIORITY||Odds Ratio (OR)|2.7||||0.022|TWO_SIDED|95.0|1.15|6.34|||Regression, Logistic|||||6.34|1.15|0.022
71015812|NCT03733301|141539274|SUPERIORITY||Odds Ratio (OR)|2.88||||0.002|TWO_SIDED|95.0|1.48|5.61|||Regression, Logistic|||||5.61|1.48|0.002
71015813|NCT03733301|141539274|SUPERIORITY||Odds Ratio (OR)|3.84|||<|0.001|TWO_SIDED|95.0|1.98|7.46|||Regression, Logistic|||||7.46|1.98|<0.001
71015814|NCT03733301|141539275|SUPERIORITY||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.209|<|0.001|TWO_SIDED|95.0|-1.23|-0.41|||Mixed Models Analysis|||||-0.41|-1.23|<0.001
71015815|NCT03733301|141539275|SUPERIORITY||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.209|<|0.001|TWO_SIDED|95.0|-1.33|-0.51|||Mixed Models Analysis|||||-0.51|-1.33|<0.001
71015816|NCT03733301|141539276|SUPERIORITY||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|0.319|<|0.001|TWO_SIDED|95.0|-1.78|-0.52|||Mixed Models Analysis|||||-0.52|-1.78|<0.001
71015817|NCT03733301|141539276|SUPERIORITY||Mean Difference (Final Values)|-1.66|STANDARD_ERROR_OF_MEAN|0.322|<|0.001|TWO_SIDED|95.0|-2.3|-1.3|||Mixed Models Analysis|||||-1.30|-2.30|<0.001
71015818|NCT03733301|141539277|SUPERIORITY||Odds Ratio (OR)|2.57|||<|0.001|TWO_SIDED|95.0|1.47|4.49|||Regression, Logistic|||||4.49|1.47|<0.001
71015819|NCT03733301|141539277|SUPERIORITY||Odds Ratio (OR)|3.56|||<|0.001|TWO_SIDED|95.0|2.0|6.32|||Regression, Logistic|||||6.32|2.00|<0.001
71015820|NCT03733301|141539278|SUPERIORITY||Odds Ratio (OR)|1.3||||0.715|TWO_SIDED|95.0|0.32|5.31|||Regression, Logistic|||||5.31|0.32|0.715
71015821|NCT03733301|141539278|SUPERIORITY||Odds Ratio (OR)|3.02||||0.083|TWO_SIDED|95.0|0.86|10.56|||Regression, Logistic|||||10.56|0.86|0.083
71015822|NCT03733301|141539279|SUPERIORITY||Mean Difference (Final Values)|-8.48|STANDARD_ERROR_OF_MEAN|2.663||0.002|TWO_SIDED|95.0|-13.72|-3.24|||Mixed Models Analysis|||||-3.24|-13.72|0.002
71015823|NCT03733301|141539279|SUPERIORITY||Mean Difference (Final Values)|-14.38|STANDARD_ERROR_OF_MEAN|2.662|<|0.001|TWO_SIDED|95.0|-19.62|-9.14|||Mixed Models Analysis|||||-9.14|-19.62|<0.001
71015824|NCT03733301|141539280|SUPERIORITY||Odds Ratio (OR)|3.21||||0.204|TWO_SIDED|95.0|0.53|19.37|||Regression, Logistic|||||19.37|0.53|0.204
71049887|NCT02504671|141606194|OTHER||Mean Difference (Net)|-15.43||||0.004|TWO_SIDED|95.0|-25.78|-5.07||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,CDAI|||-5.07|-25.78|0.004
71049888|NCT02504671|141606194|OTHER||Mean Difference (Net)|-19.88|||<|0.001|TWO_SIDED|95.0|-29.7|-10.06||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,CDAI|||-10.06|-29.70|<0.001
71049889|NCT02504671|141606195|OTHER||Mean Difference (Net)|0.01||||0.938|TWO_SIDED|95.0|-0.14|0.16||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, HAQ-DI|||0.16|-0.14|0.938
71049890|NCT02504671|141606195|OTHER||Mean Difference (Net)|0.0||||0.981|TWO_SIDED|95.0|-0.15|0.15||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, HAQ-DI|||0.15|-0.15|0.981
71049891|NCT02504671|141606195|OTHER||Mean Difference (Net)|-0.01||||0.857|TWO_SIDED|95.0|-0.16|0.14||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, HAQ-DI|||0.14|-0.16|0.857
71049892|NCT02504671|141606195|OTHER||Mean Difference (Net)|0.05||||0.592|TWO_SIDED|95.0|-0.13|0.22||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, HAQ-DI|||0.22|-0.13|0.592
71049893|NCT02504671|141606195|OTHER||Mean Difference (Net)|0.01||||0.917|TWO_SIDED|95.0|-0.16|0.18||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, HAQ-DI|||0.18|-0.16|0.917
71049894|NCT02504671|141606195|OTHER||Mean Difference (Net)|-0.05||||0.545|TWO_SIDED|95.0|-0.23|0.12||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, HAQ-DI|||0.12|-0.23|0.545
71049895|NCT02504671|141606195|OTHER||Mean Difference (Net)|0.04||||0.707|TWO_SIDED|95.0|-0.16|0.24||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, HAQ-DI|||0.24|-0.16|0.707
71049896|NCT02504671|141606195|OTHER||Mean Difference (Net)|0.05||||0.603|TWO_SIDED|95.0|-0.15|0.26||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, HAQ-DI|||0.26|-0.15|0.603
71049897|NCT02504671|141606195|OTHER||Mean Difference (Net)|-0.07||||0.473|TWO_SIDED|95.0|-0.27|0.13||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, HAQ-DI|||0.13|-0.27|0.473
71049898|NCT02504671|141606195|OTHER||Mean Difference (Net)|0.0||||0.987|TWO_SIDED|95.0|-0.21|0.22||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, HAQ-DI|||0.22|-0.21|0.987
71015825|NCT03733301|141539280|SUPERIORITY||Odds Ratio (OR)|6.99||||0.025|TWO_SIDED|95.0|1.27|38.53|||Regression, Logistic|||||38.53|1.27|0.025
71015826|NCT03733301|141539281|SUPERIORITY||Mean Difference (Final Values)|-8.97|STANDARD_ERROR_OF_MEAN|2.591|<|0.001|TWO_SIDED|95.0|-14.07|-3.87|||Mixed Models Analysis|||||-3.87|-14.07|<0.001
71015827|NCT03733301|141539281|SUPERIORITY||Mean Difference (Final Values)|-11.69|STANDARD_ERROR_OF_MEAN|2.584|<|0.001|TWO_SIDED|95.0|-16.78|-6.61|||Mixed Models Analysis|||||-6.61|-16.78|<0.001
71015828|NCT03733301|141539282|SUPERIORITY|||||||0.721|||||||Fisher Exact|||||||0.721
71015829|NCT03733301|141539282|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
71015830|NCT03733301|141539283|SUPERIORITY||Mean Difference (Final Values)|-65.16|STANDARD_ERROR_OF_MEAN|24.149||0.0073|TWO_SIDED|95.0|-112.87|-17.65|||ANOVA|||||-17.65|-112.87|0.0073
71015831|NCT03733301|141539283|SUPERIORITY||Mean Difference (Final Values)|-91.14|STANDARD_ERROR_OF_MEAN|24.038||0.0002|TWO_SIDED|95.0|-138.43|-43.85|||ANOVA|||||-43.85|-138.43|0.0002
71015832|NCT03733301|141539284|SUPERIORITY||Mean Difference (Final Values)|-16.44|STANDARD_ERROR_OF_MEAN|4.658|<|0.001|TWO_SIDED|95.0|-25.6|-7.27|||Mixed Models Analysis|||||-7.27|-25.60|< 0.001
71015833|NCT03733301|141539284|SUPERIORITY||Mean Difference (Final Values)|-24.22|STANDARD_ERROR_OF_MEAN|4.672|<|0.001|TWO_SIDED|95.0|-33.42|-15.03|||Mixed Models Analysis|||||-15.03|-33.42|< 0.001
71015834|NCT03733301|141539285|SUPERIORITY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|1.046||0.006|TWO_SIDED|95.0|-4.96|-0.84|||Mixed Models Analysis|||||-0.84|-4.96|0.006
71015835|NCT03733301|141539285|SUPERIORITY||Mean Difference (Final Values)|-5.23|STANDARD_ERROR_OF_MEAN|1.043|<|0.001|TWO_SIDED|95.0|-7.28|-3.18|||Mixed Models Analysis|||||-3.18|-7.28|< 0.001
71015836|NCT03733301|141539286|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.13||0.005|TWO_SIDED|95.0|-0.63|-0.12|||Mixed Models Analysis|||||-0.12|-0.63|0.005
71015837|NCT03733301|141539286|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-0.75|-0.24|||Mixed Models Analysis|||||-0.24|-0.75|< 0.001
71015838|NCT03733301|141539287|SUPERIORITY||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.425||0.083|TWO_SIDED|95.0|-1.57|0.1|||Mixed Models Analysis|||HADS Depression||0.10|-1.57|0.083
71015839|NCT03733301|141539287|SUPERIORITY||Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.423||0.016|TWO_SIDED|95.0|-1.85|-0.19|||Mixed Models Analysis|||HADS Depression||-0.19|-1.85|0.016
71015840|NCT03733301|141539287|SUPERIORITY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.415||0.051|TWO_SIDED|95.0|-1.63|0.0|||Mixed Models Analysis|||HADS Anxiety||0.00|-1.63|0.051
71104723|NCT01098747|141716675|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
71104724|NCT01098747|141716675|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
71015841|NCT03733301|141539287|SUPERIORITY||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.413||0.028|TWO_SIDED|95.0|-1.72|-0.1|||Mixed Models Analysis|||HADS Anxiety||-0.10|-1.72|0.028
71015842|NCT03733301|141539288|SUPERIORITY||Mean Difference (Final Values)|-1.92|STANDARD_ERROR_OF_MEAN|0.832||0.022|TWO_SIDED|95.0|-3.56|-0.28|||Mixed Models Analysis|||||-0.28|-3.56|0.022
71015843|NCT03733301|141539288|SUPERIORITY||Mean Difference (Final Values)|-3.31|STANDARD_ERROR_OF_MEAN|0.829|<|0.001|TWO_SIDED|95.0|-4.94|-1.68|||Mixed Models Analysis|||||-1.68|-4.94|< 0.001
71015844|NCT03733301|141539289|SUPERIORITY||Mean Difference (Final Values)|2.01|STANDARD_ERROR_OF_MEAN|2.569||0.435|TWO_SIDED|95.0|-3.06|7.08|||Mixed Models Analysis|||Absenteeism||7.08|-3.06|0.435
71015845|NCT03733301|141539289|SUPERIORITY||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|2.569||0.706|TWO_SIDED|95.0|-4.1|6.04|||Mixed Models Analysis|||Absenteeism||6.04|-4.10|0.706
71015846|NCT03733301|141539289|SUPERIORITY|Presenteeism|Mean Difference (Final Values)|-8.12|STANDARD_ERROR_OF_MEAN|4.384||0.066|TWO_SIDED|95.0|-16.78|0.54|||Mixed Models Analysis|||||0.54|-16.78|0.066
71015847|NCT03733301|141539289|SUPERIORITY||Mean Difference (Final Values)|-10.73|STANDARD_ERROR_OF_MEAN|4.336||0.014|TWO_SIDED|95.0|-19.3|-2.17|||Mixed Models Analysis|||Presenteeism||-2.17|-19.30|0.014
71015848|NCT03733301|141539289|SUPERIORITY|Work Productivity Loss|Mean Difference (Final Values)|-7.93|STANDARD_ERROR_OF_MEAN|4.511||0.081|TWO_SIDED|95.0|-16.84|0.99|||Mixed Models Analysis|||||0.99|-16.84|0.081
71015849|NCT03733301|141539289|SUPERIORITY||Mean Difference (Final Values)|-10.71|STANDARD_ERROR_OF_MEAN|4.473||0.018|TWO_SIDED|95.0|-19.55|1.88|||Mixed Models Analysis|||Work productivity Loss||1.88|-19.55|0.018
71015850|NCT03733301|141539289|SUPERIORITY||Mean Difference (Final Values)|-9.8|STANDARD_ERROR_OF_MEAN|3.511||0.006|TWO_SIDED|95.0|-16.71|-2.89|||Mixed Models Analysis|||Activity Impairment||-2.89|-16.71|0.006
71015851|NCT03733301|141539289|SUPERIORITY||Mean Difference (Final Values)|-10.5|STANDARD_ERROR_OF_MEAN|3.5||0.003|TWO_SIDED|95.0|-17.39|-3.61|||Mixed Models Analysis|||Activity Impairment||-3.61|-17.39|0.003
71015852|NCT03733301|141539290|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.017||0.176|TWO_SIDED|95.0|-0.01|0.06|||Mixed Models Analysis|||Health State Index US||0.06|-0.01|0.176
71015853|NCT03733301|141539290|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.017||0.004|TWO_SIDED|95.0|0.02|0.09|||Mixed Models Analysis|||Health State Index US||0.09|0.02|0.004
71015854|NCT03733301|141539290|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.024||0.176|TWO_SIDED|95.0|-0.01|0.08|||Mixed Models Analysis|||Health State Index UK||0.08|-0.01|0.176
71015855|NCT03733301|141539290|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.024||0.003|TWO_SIDED|95.0|0.02|0.12|||Mixed Models Analysis|||Health State Index UK||0.12|0.02|0.003
71015856|NCT03733301|141539291|SUPERIORITY||Mean Difference (Final Values)|4.12|STANDARD_ERROR_OF_MEAN|2.593||0.113|TWO_SIDED|95.0|-0.98|9.23|||Mixed Models Analysis|||||9.23|-0.98|0.113
71015857|NCT03733301|141539291|SUPERIORITY||Mean Difference (Final Values)|6.06|STANDARD_ERROR_OF_MEAN|2.592||0.02|TWO_SIDED|95.0|0.96|11.16|||Mixed Models Analysis|||||11.16|0.96|0.020
71015858|NCT03733301|141539292|SUPERIORITY||Mean Difference (Final Values)|10.04|STANDARD_ERROR_OF_MEAN|4.36||0.022|TWO_SIDED|95.0|1.46|18.36|||ANCOVA|||||18.36|1.46|0.022
71015859|NCT03733301|141539292|SUPERIORITY||Mean Difference (Final Values)|17.33|STANDARD_ERROR_OF_MEAN|4.34|<|0.001|TWO_SIDED|95.0|8.79|25.88|||ANCOVA|||||25.88|8.79|< 0.001
71015860|NCT03733301|141539293|SUPERIORITY||Odds Ratio (OR)|3.83||||0.006|TWO_SIDED|95.0|1.46|10.03|||Regression, Logistic|||||10.03|1.46|0.006
71015861|NCT03733301|141539293|SUPERIORITY||Odds Ratio (OR)|4.58||||0.002|TWO_SIDED|95.0|1.77|11.87|||Regression, Logistic|||||11.87|1.77|0.002
71015862|NCT04637815|141539294|EQUIVALENCE|t-tests for continuous variables and chi-squared tests for categorical variables|||||||TWO_SIDED|0.0||||Statistical threshold of significance is .05.|t-test, 2 sided||||We also conducted difference in differences (DID) analysis by first constructing measures of difference between follow-up and baseline for each participant for each measure and then comparing the means of these difference measures for each arm.|||
71015863|NCT04637815|141539295|EQUIVALENCE|t-tests for continuous variables and chi-squared tests for categorical variables||||||||||||Statistical threshold of significance is .05.|t-test, 2 sided||||We also conducted difference in differences (DID) analysis by first constructing measures of difference between follow-up and baseline for each participant for each measure and then comparing the means of these difference measures for each arm.|||
71104725|NCT01098747|141716675|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
71015864|NCT04637815|141539296|EQUIVALENCE|t-tests for continuous variables and chi-squared tests for categorical variables||||||||||||Statistical threshold of significance is .05.|t-test, 2 sided||||We also conducted difference in differences (DID) analysis by first constructing measures of difference between follow-up and baseline for each participant for each measure and then comparing the means of these difference measures for each arm.|||
71015865|NCT04637815|141539297|EQUIVALENCE|t-tests for continuous variables and chi-squared tests for categorical variables||||||||||||Statistical threshold of significance is .05.|t-test, 2 sided||||We also conducted difference in differences (DID) analysis by first constructing measures of difference between follow-up and baseline for each participant for each measure and then comparing the means of these difference measures for each arm.|||
71015866|NCT04637815|141539298|EQUIVALENCE|t-tests for continuous variables and chi-squared tests for categorical variables||||||||||||Statistical threshold of significance is .05.|t-test, 2 sided||||We also conducted difference in differences (DID) analysis by first constructing measures of difference between follow-up and baseline for each participant for each measure and then comparing the means of these difference measures for each arm.|||
71015867|NCT00337727|141539299|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Superiority based on 2-sided level of significance of 0.05, based on a logistic regression model that included terms for treatment group, region and gender.|Regression, Logistic|||||||<0.01
71015868|NCT00337727|141539300|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Superiority based on 2-sided level of significance of 0.05, based on a logistic regression model that included terms for treatment group, region and gender.|Regression, Logistic|||||||<0.01
71015869|NCT00577031|141539317|SUPERIORITY_OR_OTHER|||||||0.0076|||||||Signed-rank test|||Change from baseline to last visit||||0.0076
71015870|NCT06067191|141539318|OTHER||Difference in Least Square Mean|-312.28||||0.0009|TWO_SIDED|95.0|-489.17|-135.38|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||-135.38|-489.17|0.0009
71015871|NCT06067191|141539319|OTHER||Difference in Least Square Mean|-1.45||||0.0047|TWO_SIDED|95.0|-2.43|-0.47|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||-0.47|-2.43|0.0047
71015872|NCT06067191|141539320|OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71015873|NCT06067191|141539321|OTHER|||||||0.0051|||||||Log Rank|||||||0.0051
71015874|NCT06067191|141539322|OTHER|||||||0.0077|||||||Log Rank|||||||0.0077
71015875|NCT06067191|141539323|OTHER||Difference in Least Square Mean|-87.4||||0.0268|TWO_SIDED|95.0|-164.3|-10.49|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||-10.49|-164.30|0.0268
71015876|NCT06067191|141539324|OTHER||Difference in Least Square Mean|-0.99||||0.0865|TWO_SIDED|95.0|-2.13|0.15|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||0.15|-2.13|0.0865
71015877|NCT06067191|141539325|OTHER|||||||0.0008|||||||Log Rank|||||||0.0008
71015878|NCT06067191|141539326|OTHER|||||||0.8579|||||||Log Rank|||||||0.8579
71015879|NCT06067191|141539327|OTHER||Difference in Least Square Mean|-93.95||||0.0658|TWO_SIDED|95.0|-194.26|6.36|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||6.36|-194.26|0.0658
71015880|NCT06067191|141539328|OTHER||Difference in Least Square Mean|-93.95||||0.0658|TWO_SIDED|95.0|-194.26|6.36|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||6.36|-194.26|0.0658
71015881|NCT06067191|141539329|OTHER||Difference in Least Square Mean|-0.93||||0.203|TWO_SIDED|95.0|-2.38|0.52|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||0.52|-2.38|0.2030
71015882|NCT04764669|141539348|SUPERIORITY|Primary comparisons were: DLB without amyloid copathology versus DLB with amyloid copathology|Least squares mean difference|-20.022|||||TWO_SIDED|95.0|-77.635|37.591||||||||37.591|-77.635|
71015883|NCT04764669|141539348|SUPERIORITY|Primary comparisons were: PDD without amyloid copathology versus PDD with amyloid copathology.|Least squares mean difference|-175.65|||||TWO_SIDED|95.0|-287.407|-63.893||||||||-63.893|-287.407|
71015884|NCT04776135|141539356|OTHER|AUC0-t was log-transformed and analyzed by analysis of variance using administration groups, the administration route, study periods, and subjects as factors. Estimates of the mean values on the log scale, the mean difference between administration routes on the log scale, and 90% CIs for the difference were back transformed to present mean ratios and their 90% CIs for administration via NGT to oral administration.|Ratio (NGT/oral)|0.987|||||TWO_SIDED|90.0|0.936|1.041|||ANOVA|||For AUC0-t, MT-1186 orally Versus MT-1186 via NGT||1.041|0.936|
71015885|NCT04776135|141539356|OTHER|AUC0-inf was log-transformed and analyzed by analysis of variance using administration groups, the administration route, study periods, and subjects as factors. Estimates of the mean values on the log scale, the mean difference between administration routes on the log scale, and 90% CIs for the difference were back transformed to present mean ratios and their 90% CIs for administration via NGT to oral administration.|Ratio (NGT/oral)|0.981|||||TWO_SIDED|90.0|0.931|1.033|||ANOVA|||For AUC0-inf, MT-1186 orally Versus MT-1186 via NGT||1.033|0.931|
71015886|NCT04776135|141539357|OTHER|Cmax was log-transformed and analyzed by analysis of variance using administration groups, the administration route, study periods, and subjects as factors. Estimates of the mean values on the log scale, the mean difference between administration routes on the log scale, and 90% CIs for the difference were back transformed to present mean ratios and their 90% CIs for administration via NGT to oral administration.|Ratio (NGT/oral)|1.052|||||TWO_SIDED|90.0|0.903|1.227|||ANOVA|||MT-1186 orally Versus MT-1186 via NGT||1.227|0.903|
71015887|NCT01783860|141539371|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||t-test, 1 sided|||||||0.03
71015888|NCT01783860|141539372|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 1 sided|||||||0.01
71015889|NCT01783860|141539373|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 1 sided|||||||0.007
71015890|NCT01783860|141539374|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 1 sided|||||||> 0.05
71015891|NCT01783860|141539375|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 1 sided|||||||0.02
71015892|NCT01783860|141539376|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||t-test, 1 sided|||||||0.08
71049899|NCT02504671|141606195|OTHER||Mean Difference (Net)|-0.04||||0.713|TWO_SIDED|95.0|-0.25|0.17||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, HAQ-DI|||0.17|-0.25|0.713
70930180|NCT04084574|141358402|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.5||0.07926|TWO_SIDED|95.0|-0.33|0.44|||t-test, 2 sided||Between group difference from baseline for Standard of Care group minus Behavioral Diet Counseling group.|||0.44|-0.33|0.07926
70930181|NCT04084574|141358404|SUPERIORITY||Mean Difference (Net)|11.7|STANDARD_DEVIATION|59.3||0.0673|TWO_SIDED|95.0|-34.2|58.6|||t-test, 2 sided|||||58.6|-34.2|0.0673
71015893|NCT03992261|141539384|OTHER|"Mean, median, SD, minimum/maximum determined for total amount of test article used by each subject in Safety, Evaluable, and PK populations HPA Axis Suppression: Proportion of subjects manifesting laboratory evidence of adrenal suppression at EOS were presented with 95% confidence intervals (CIs) for Evaluable and Safety populations. Descriptive statistics for daily dose of test article were tabulated separately for suppressed and non-suppressed subjects.~PK: Screening, Day 8, Day 15"||||||0.05|||||||ANOVA|||Outcome measure: extent of exposure, HPA axis suppression, and pharmacokinetic analysis.||||0.05
71015894|NCT00769132|141539393|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two treatments are comparable if the geometric mean ratio is contained within the interval \[0.50-2.00\].|Geometric least-squares mean ratio|1.12||||||90.0|0.9|1.38||||||The endpoint is the urine levels of 11-dTxB2 on Day 7 following a 7 day course of daily dosing in the overall 24 hour collection interval. The point estimate and 90% confidence intervals (CIs) were calculated for the geometric mean ratio (GMR) \[Treatment A/B\] of the urine levels of 11-dTxB2 on Day 7.||1.38|0.9|
71049900|NCT02504671|141606195|OTHER||Mean Difference (Net)|-0.1||||0.357|TWO_SIDED|95.0|-0.31|0.11||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, HAQ-DI|||0.11|-0.31|0.357
71049901|NCT02504671|141606195|OTHER||Mean Difference (Final Values)|0.04||||0.748|TWO_SIDED|95.0|-0.19|0.26||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, HAQ-DI|||0.26|-0.19|0.748
71049902|NCT02504671|141606195|OTHER||Mean Difference (Net)|-0.11||||0.327|TWO_SIDED|95.0|-0.34|0.11||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, HAQ-DI|||0.11|-0.34|0.327
71049903|NCT02504671|141606195|OTHER||Mean Difference (Net)|-0.1||||0.395|TWO_SIDED|95.0|-0.32|0.13||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, HAQ-DI|||0.13|-0.32|0.395
71049904|NCT02504671|141606195|OTHER||Mean Difference (Net)|-0.05||||0.71|TWO_SIDED|95.0|-0.3|0.21||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, HAQ-DI|||0.21|-0.30|0.710
71049905|NCT02504671|141606195|OTHER||Mean Difference (Net)|-0.04||||0.74|TWO_SIDED|95.0|-0.3|0.21||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, HAQ-DI|||0.21|-0.30|0.740
71049906|NCT02504671|141606195|OTHER||Mean Difference (Net)|-0.11||||0.398|TWO_SIDED|95.0|-0.36|0.14||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, HAQ-DI|||0.14|-0.36|0.398
71049907|NCT02504671|141606195|OTHER||Mean Difference (Net)|0.16||||0.364|TWO_SIDED|95.0|-0.19|0.52||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, HAQ-DI|||0.52|-0.19|0.364
71049908|NCT02504671|141606195|OTHER||Mean Difference (Net)|0.12||||0.503|TWO_SIDED|95.0|-0.23|0.46||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, HAQ-DI|||0.46|-0.23|0.503
71049909|NCT02504671|141606195|OTHER||Mean Difference (Net)|-0.08||||0.647|TWO_SIDED|95.0|-0.42|0.26||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, HAQ-DI|||0.26|-0.42|0.647
71049910|NCT02504671|141606195|OTHER||Mean Difference (Net)|-0.02||||0.91|TWO_SIDED|95.0|-0.37|0.33||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, HAQ-DI|||0.33|-0.37|0.910
71049911|NCT02504671|141606195|OTHER||Mean Difference (Net)|-0.08||||0.66|TWO_SIDED|95.0|-0.42|0.26||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, HAQ-DI|||0.26|-0.42|0.660
71049912|NCT02504671|141606195|OTHER||Mean Difference (Net)|-0.16||||0.34|TWO_SIDED|95.0|-0.5|0.17||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, HAQ-DI|||0.17|-0.50|0.340
71049913|NCT02504671|141606195|OTHER||Mean Difference (Net)|0.02||||0.902|TWO_SIDED|95.0|-0.34|0.39||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, HAQ-DI|||0.39|-0.34|0.902
71049914|NCT02504671|141606195|OTHER||Mean Difference (Net)|-0.07||||0.687|TWO_SIDED|95.0|-0.42|0.28||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, HAQ-DI|||0.28|-0.42|0.687
71049915|NCT02504671|141606195|OTHER||Mean Difference (Net)|-0.09||||0.599|TWO_SIDED|95.0|-0.44|0.25||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, HAQ-DI|||0.25|-0.44|0.599
71049916|NCT02504671|141606195|OTHER||Mean Difference (Net)|-0.04||||0.588|TWO_SIDED|95.0|-0.19|0.11||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, HAQ-DI|||0.11|-0.19|0.588
71049917|NCT02504671|141606195|OTHER||Mean Difference (Net)|-0.09||||0.259|TWO_SIDED|95.0|-0.23|0.06||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, HAQ-DI|||0.06|-0.23|0.259
70930182|NCT04084574|141358405|SUPERIORITY||Mean Difference (Net)|-10.7|STANDARD_DEVIATION|189.3||0.8821|TWO_SIDED|95.0|-157.8|136.4|||t-test, 2 sided||Between group difference from baseline for Standard of Care group minus Behavioral Diet Counseling group.|||136.4|-157.8|0.8821
70930183|NCT04084574|141358406|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_DEVIATION|3.3||0.6479|TWO_SIDED|95.0|-2.0|3.1|||t-test, 2 sided||Between group difference from baseline for Standard of Care group minus Behavioral Diet Counseling group.|||3.1|-2.0|0.6479
70930184|NCT04084574|141358407|SUPERIORITY||Mean Difference (Net)|7.0|STANDARD_DEVIATION|21.8||0.4044|TWO_SIDED|95.0|-10.0|24.0|||t-test, 2 sided||Between group difference in mean blood pressure change from baseline for Behavioral Diet Counseling group minus Standard of Care group.|||24.0|-10.0|0.4044
70930185|NCT04084574|141358408|SUPERIORITY||Mean Difference (Net)|1.34|STANDARD_DEVIATION|2.91||0.2374|TWO_SIDED|95.0|-0.97|3.6|||t-test, 2 sided|||||3.60|-0.97|0.2374
70930186|NCT04084574|141358409|SUPERIORITY||Mean Difference (Net)|-2.69|STANDARD_DEVIATION|13.62||0.6188|TWO_SIDED|95.0|-13.71|8.33|||t-test, 2 sided||Between group difference from 12 weeks to 24 weeks for Behavioral Diet Counseling group minus Standard of Care group.|||8.33|-13.71|0.6188
70930187|NCT04084574|141358410|SUPERIORITY||Mean Difference (Net)|-1.39|STANDARD_DEVIATION|1.79||0.0546|TWO_SIDED|95.0|-2.82|0.03|||t-test, 2 sided||Between group difference from 12 weeks to 24 weeks for Behavioral Diet Counseling group minus Standard of Care group.|||0.03|-2.82|0.0546
70930188|NCT04084574|141358411|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_DEVIATION|1.2||1|TWO_SIDED|95.0|-0.98|0.98|||t-test, 2 sided||Between group difference from 12 weeks to 24 weeks for Behavioral Diet Counseling group minus Standard of Care group.|||0.98|-0.98|1.00
70930189|NCT04084574|141358412|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_DEVIATION|1.5||1|TWO_SIDED|95.0|-0.89|1.49|||t-test, 2 sided|||||1.49|-0.89|1.00
70930190|NCT03334695|141358430|SUPERIORITY|||||||0.012|||||||Wilcoxon Rank Sum test|||||||0.012
70930191|NCT06603766|141358521|SUPERIORITY|||||||0.83|||||||Chi-squared|||||||0.83
70930192|NCT06603766|141358522|SUPERIORITY|||||||0.46|||||||Chi-squared|||||||0.46
70930193|NCT06603766|141358523|SUPERIORITY|||||||0.008|||||||Chi-squared|||||||0.008
70930194|NCT06603766|141358524|SUPERIORITY|||||||0.032|||||||Chi-squared|||||||0.032
71015895|NCT00769132|141539393|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.87||||||90.0|0.71|1.07||||||||1.07|0.71|
71015896|NCT00769132|141539393|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.8||||||90.0|0.65|0.98||||||||0.98|0.65|
70930195|NCT06603766|141358525|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71015897|NCT00769132|141539393|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.89||||||90.0|0.72|1.09||||||||1.09|0.72|
71015898|NCT00769132|141539393|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.91||||||90.0|0.74|1.12||||||||1.12|0.74|
70930196|NCT06603766|141358526|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
70930197|NCT03812614|141358584|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.07|TWO_SIDED|95.0|-0.05|1.14|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Linear mixed model with random intercept and slope was used to compare the change in HbA1c as a function of time (included using restricted cubic splines), the interaction between time and intervention arm, baseline A1c and whether PT-SP live together (stratification variables), baseline insulin use, age, vital hunger, and preferred language.||1.14|-0.05|0.07
70930198|NCT03812614|141358585|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.96|TWO_SIDED|95.0|-0.67|0.64|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Linear mixed model with random intercept and slope was used to compare the change in A1c as a function of time (included using restricted cubic splines), the interaction between time and intervention arm, baseline A1c and whether PT-SP live together (stratification variables), baseline insulin use, age, vital hunger, and preferred language||0.64|-0.67|0.96
70930199|NCT03812614|141358586|SUPERIORITY||Mean Difference (Final Values)|-1.51||||0.55|TWO_SIDED|95.0|-6.4|3.38|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Change in patient SBP was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||3.38|-6.40|0.55
70930200|NCT03812614|141358587|SUPERIORITY||Mean Difference (Final Values)|5.74||||0.03|TWO_SIDED|95.0|0.57|10.91|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Change in patient SBP was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||10.91|0.57|0.03
70930201|NCT03812614|141358588|SUPERIORITY||Mean Difference (Final Values)|-0.29||||0.76|TWO_SIDED|95.0|-2.15|1.58|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Change in patient diabetes distress was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||1.58|-2.15|0.76
70930202|NCT03812614|141358589|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.72|TWO_SIDED|95.0|-2.11|1.46|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Change in patient diabetes distress was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||1.46|-2.11|0.72
70930203|NCT03812614|141358590|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.38|TWO_SIDED|95.0|-0.76|0.29|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Change in patient health eating was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.29|-0.76|0.38
70930204|NCT03812614|141358591|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.7|TWO_SIDED|95.0|-1.11|0.74|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient physical activity was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.74|-1.11|0.70
70930205|NCT03812614|141358592|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.75|TWO_SIDED|95.0|-0.53|0.74|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient diabetes medication adherence was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.74|-0.53|0.75
71015899|NCT00769132|141539393|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|1.02||||||90.0|0.83|1.25||||||||1.25|0.83|
71015900|NCT00769132|141539394|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|1.04||||||90.0|0.92|1.17||||||||1.17|0.92|
71015901|NCT00769132|141539394|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.9||||||90.0|0.8|1.01||||||||1.01|0.8|
71015902|NCT00769132|141539394|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.56||||||90.0|0.49|0.63||||||||0.63|0.49|
71015903|NCT00769132|141539394|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.58||||||90.0|0.51|0.65||||||||0.65|0.51|
71015904|NCT00769132|141539394|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.62||||||90.0|0.55|0.7||||||||0.7|0.55|
71015905|NCT00769132|141539394|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.64||||||90.0|0.57|0.72||||||||0.72|0.57|
70930206|NCT03812614|141358592|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.94|TWO_SIDED|95.0|-0.98|0.91|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient blood pressure medication adherence (days/week meds were taken) was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c). Analyses were ITT and thus based on data from all enrolled patients.||0.91|-0.98|0.94
71015906|NCT00877799|141539403|SUPERIORITY_OR_OTHER|||||||0.057|||||||t-test, 2 sided|||||||0.057
71015907|NCT00877799|141539404|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71015908|NCT00877799|141539405|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71015909|NCT00127192|141539428|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-3.6|||<|0.001||95.0|-4.3|-3.0||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-3.0|-4.3|<0.001
71015910|NCT00127192|141539428|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-3.2|||<|0.001||95.0|-3.9|-2.6||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-2.6|-3.9|<0.001
71015911|NCT00127192|141539428|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-3.3|||<|0.001||95.0|-3.9|-2.7||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-2.7|-3.9|<0.001
71015912|NCT00127192|141539428|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-2.6|||<|0.001||95.0|-3.2|-2.0||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-2.0|-3.2|<0.001
71015913|NCT00127192|141539429|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Tukeys linear trend test based on ANCOVA|Linear contrast including all groups was tested using ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline||||||<0.001
71015914|NCT00127192|141539429|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-1.04|||<|0.001||95.0|-1.21|-0.86||No multiplicity adjustment was done between trend test of primary analysis and pairwise comparisons, but the multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-0.86|-1.21|<0.001
70930207|NCT03812614|141358592|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.42|TWO_SIDED|95.0|-1.46|0.61|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient cholesterol medication adherence (days/week meds were taken) was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c). Analyses were ITT and thus based on data from all enrolled patients.||0.61|-1.46|0.42
71015915|NCT00127192|141539429|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-0.96|||<|0.001||95.0|-1.14|-0.79||No multiplicity adjustment was done between trend test of primary analysis and pairwise comparisons, the multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-0.79|-1.14|<0.001
71015916|NCT00127192|141539429|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-0.99|||<|0.001||95.0|-1.16|-0.82||No multiplicity adjustment was done between trend test of primary analysis and pairwise comparisons, the multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-0.82|-1.16|<0.001
71015917|NCT00127192|141539429|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-0.69|||<|0.001||95.0|-0.85|-0.52||No multiplicity adjustment was done between trend test of primary analysis and pairwise comparisons, the multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-0.52|-0.85|<0.001
71015918|NCT00127192|141539430|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-23.2|||<|0.001||95.0|-29.8|-16.6||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-16.6|-29.8|<0.001
70930208|NCT03812614|141358593|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.96|TWO_SIDED|95.0|-0.54|0.52|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient self-efficacy was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.52|-0.54|0.96
71015919|NCT00127192|141539430|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-20.8|||<|0.001||95.0|-27.4|-14.3||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-14.3|-27.4|<0.001
71015920|NCT00127192|141539430|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-17.7|||<|0.001||95.0|-24.2|-11.2||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-11.2|-24.2|<0.001
71015921|NCT00127192|141539430|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-15.9|||<|0.001||95.0|-22.3|-9.6||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-9.6|-22.3|<0.001
71029411|NCT03561883|141566702|OTHER|Negative binomial model was used to deal with data overdispersion|Difference in Proportion Ratio|0.034|||||TWO_SIDED|95.0|-0.054|0.123|||||Difference in Proportion Ratio, (1500 mg IW-3718 BID + PPI) - (Placebo + PPI)|Poisson regression including the fixed categorical effect of treatment, the baseline esophagitis status (present vs. not present) and baseline WHSS (\<3 vs. ≥3), the covariate of baseline proportion of heartburn-free days, and with the diary entry duration (in days) as a weight variable adjusted in the model was applied.||0.123|-0.054|
71029412|NCT01988922|141566708|OTHER|Differences between CYP2B6\*1/\*1, CYP2B6\*1/\*6, and CYP2B6\*6/\*6 genotypes for pharmacokinetic parameters were analyzed using one-way ANOVA followed by the Student-Newman-Keuls test for multiple comparisons (Sigmaplot 12.5; Systat Software, Inc, USA). Nonnormal data were log transformed for analysis but reported as the nontransformed results.|||||<|0.05|||||||ANOVA|One-way ANOVA followed by the Student-Newman-Keuls test for multiple comparisons||||||<0.05
70930209|NCT03812614|141358594|SUPERIORITY||Mean Difference (Final Values)|2.93||||0.4|TWO_SIDED|95.0|-3.92|9.78|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient activation was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||9.78|-3.92|0.40
71029413|NCT04977336|141566722|SUPERIORITY|||||||0.3706|||||||ANCOVA|||||||0.3706
71029414|NCT04977336|141566722|SUPERIORITY|||||||0.5379|||||||ANCOVA|||||||0.5379
71029415|NCT04977336|141566722|SUPERIORITY|||||||0.3859|||||||ANCOVA|||||||0.3859
71029416|NCT04977336|141566722|SUPERIORITY|||||||0.0251|||||||ANCOVA|||||||0.0251
71029417|NCT04977336|141566723|SUPERIORITY|||||||0.2318|||||||ANCOVA|||||||0.2318
71029418|NCT04977336|141566723|SUPERIORITY|||||||0.7615|||||||ANCOVA|||||||0.7615
71029419|NCT04977336|141566723|SUPERIORITY|||||||0.387|||||||ANCOVA|||||||0.3870
71029420|NCT04977336|141566723|SUPERIORITY|||||||0.0823|||||||ANCOVA|||||||0.0823
71029421|NCT04977336|141566724|SUPERIORITY|||||||0.9986|||||||Cochran-Mantel-Haenszel|||||||0.9986
71029422|NCT04977336|141566724|SUPERIORITY|||||||0.4446|||||||Cochran-Mantel-Haenszel|||||||0.4446
71029423|NCT04977336|141566724|SUPERIORITY|||||||0.5978|||||||Cochran-Mantel-Haenszel|||||||0.5978
70930210|NCT03812614|141358595|SUPERIORITY||Mean Difference (Final Values)|0.75||||0.11|TWO_SIDED|95.0|-0.18|1.68|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient satisfaction with SP support was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||1.68|-0.18|0.11
70930211|NCT03812614|141358596|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.34|TWO_SIDED|95.0|-0.19|0.55|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient perception of supportive and non-supportive behaviors was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.55|-0.19|0.34
71029424|NCT04977336|141566724|SUPERIORITY|||||||0.0479|||||||Cochran-Mantel-Haenszel|||||||0.0479
71029425|NCT04977336|141566725|SUPERIORITY|||||||0.9895|||||||Cochran-Mantel-Haenszel|||||||0.9895
71029426|NCT04977336|141566725|SUPERIORITY|||||||0.2731|||||||Cochran-Mantel-Haenszel|||||||0.2731
71029427|NCT04977336|141566725|SUPERIORITY|||||||0.6492|||||||Cochran-Mantel-Haenszel|||||||0.6492
71029428|NCT04977336|141566725|SUPERIORITY|||||||0.5119|||||||Cochran-Mantel-Haenszel|||||||0.5119
71029429|NCT04977336|141566726|SUPERIORITY|||||||0.3158|||||||Cochran-Mantel-Haenszel|||||||0.3158
71029430|NCT04977336|141566726|SUPERIORITY|||||||0.3247|||||||Cochran-Mantel-Haenszel|||||||0.3247
71029431|NCT04977336|141566726|SUPERIORITY|||||||0.8424|||||||Cochran-Mantel-Haenszel|||||||0.8424
71029432|NCT04977336|141566726|SUPERIORITY|||||||0.2312|||||||Cochran-Mantel-Haenszel|||||||0.2312
71029433|NCT01347710|141566731|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value for sensitivity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule|McNemar|Two-sided McNemar's (chi-squared) test superiority||||||<0.001
71029434|NCT01347710|141566732|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule in patients under going pharmacologic stress|McNemar|Two-sided McNemar's (chi-squared) test superiority||||||<0.001
71029435|NCT01347710|141566732|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule in females|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority||||||<0.001
71029436|NCT01347710|141566732|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule in patients with BMI \>/=30|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority||||||<0.001
71029437|NCT01347710|141566733|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.891|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule in patients undergoing pharmacologic stress|Z test|z test for non inferiority for specificity||||||0.891
71029438|NCT01347710|141566733|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.546|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule in female patients|z test|z test for non-inferiority for specificity||||||.546
71029439|NCT01347710|141566733|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.538|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule BMI \>/=30|z test|z test for non-inferiority for specificity||||||.538
71029440|NCT01347710|141566734|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; LAD|McNemar|Two-sided McNemar (chi-squared) test superiority for sensitivity; LAD||||||<0.001
71029441|NCT01347710|141566734|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; LCX|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority for sensitivity; LCX||||||<0.001
71029442|NCT01347710|141566734|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; RCA|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority for sensitivity; RCA||||||<0.001
71029443|NCT01347710|141566734|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; Non-LAD|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority for sensitivity; Non-LAD||||||<0.001
71029444|NCT01347710|141566735|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.379|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; LAD|z Test|z test for non-inferiority for specificity; LAD||||||.379
71029445|NCT01347710|141566735|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.358|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; LCX|Z Test|z test for non-inferiority for specificity; LCX||||||.358
71029446|NCT01347710|141566735|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.442|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; RCA|z Test|z test for non-inferiority for specificity; RCA||||||.442
70930212|NCT03812614|141358598|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.47|TWO_SIDED|95.0|-2.67|1.23|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Support Persons (SPs) were surveyed twice, once at baseline and again at the end of their participation in the study. For SPs enrolled before the start of the COVID-19 pandemic (n=77), the follow-up survey was conducted at 12 months. Due to factors related to the pandemic, the length of the protocol was reduced from 12 to 6 months. Thus, SPs enrolled after the pandemic started (n=145) received their follow-up survey at 6 months, and 6-month change was used for predetermined SP outcomes.||1.23|-2.67|0.47
70930213|NCT03812614|141358599|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.35|TWO_SIDED|95.0|-0.78|0.27|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Support Persons (SPs) were surveyed twice, once at baseline and again at the end of their participation in the study. For SPs enrolled before the start of the COVID-19 pandemic (n=77), the follow-up survey was conducted at 12 months. Due to factors related to the pandemic, the length of the protocol was reduced from 12 to 6 months. Thus, SPs enrolled after the pandemic started (n=145) received their follow-up survey at 6 months, and 6-month change was used for predetermined SP outcomes.||0.27|-0.78|0.35
71104726|NCT01098747|141716675|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
71104727|NCT01098747|141716675|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
71104728|NCT01098747|141716675|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
71104729|NCT01098747|141716676|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.22||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||0.22|0.08|<0.001
71104730|NCT01098747|141716676|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.33||||0.281|TWO_SIDED|95.0|0.79|2.22||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||2.22|0.79|0.281
71104731|NCT01098747|141716677|SUPERIORITY_OR_OTHER||Difference in proportion|-23.93|||<|0.001|TWO_SIDED|95.0|-36.67|-11.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-11.20|-36.67|<0.001
71104732|NCT01098747|141716677|SUPERIORITY_OR_OTHER||Difference in proportion|-1.21||||0.483|TWO_SIDED|95.0|-4.12|1.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.70|-4.12|0.483
71104733|NCT01098747|141716677|SUPERIORITY_OR_OTHER||Difference in proportion|-51.93|||<|0.001|TWO_SIDED|95.0|-65.63|-38.22||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-38.22|-65.63|<0.001
71104734|NCT01098747|141716677|SUPERIORITY_OR_OTHER||Difference in proportion|-3.61||||0.174|TWO_SIDED|95.0|-7.97|0.75||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||0.75|-7.97|0.174
71104735|NCT01098747|141716677|SUPERIORITY_OR_OTHER||Difference in proportion|-66.58|||<|0.001|TWO_SIDED|95.0|-79.8|-53.35||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-53.35|-79.80|<0.001
71104736|NCT01098747|141716677|SUPERIORITY_OR_OTHER||Difference in proportion|-3.75||||0.24|TWO_SIDED|95.0|-9.38|1.89||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.89|-9.38|0.240
71104737|NCT01098747|141716677|SUPERIORITY_OR_OTHER||Difference in proportion|-61.36|||<|0.001|TWO_SIDED|95.0|-75.21|-47.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-47.50|-75.21|<0.001
71104738|NCT01098747|141716677|SUPERIORITY_OR_OTHER||Difference in proportion|1.52||||0.668|TWO_SIDED|95.0|-5.47|8.52||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.52|-5.47|0.668
71104739|NCT01098747|141716677|SUPERIORITY_OR_OTHER||Difference in proportion|-60.31|||<|0.001|TWO_SIDED|95.0|-74.28|-46.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-46.34|-74.28|<0.001
71104740|NCT01098747|141716677|SUPERIORITY_OR_OTHER||Difference in proportion|1.1||||0.98|TWO_SIDED|95.0|-7.44|7.63||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||7.63|-7.44|0.980
70850652|NCT01303224|141189458|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||Multiplicity was adjusted by using the Hochberg Procedure.|Mantel Haenszel|||Mantel-Haenszel-Test was used to compare separately each of the 3 active treatment groups with placebo using a two-sided overall significance level of 5%. The proportion of responders was tested with the following hypotheses: H0 (placebo) vs H1(Ibodutant:1mg/3mg/10mg). Approximately 80% power based on the assumptions: rate placebo 40%, expected mean therapeutic gain over placebo 15% for at least one dose of Ibodutant.||||<0.05
70850653|NCT01303224|141189459|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||Multiplicity was adjusted using the Hochberg procedure.|Mantel Haenszel|||||||<0.05
70850654|NCT00843284|141189479|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.16|STANDARD_DEVIATION|2.52|<|0.0001||95.0|-4.35|-3.97|||t-test, 2 sided|One sample t-test||Change from Baseline; observational study||-3.97|-4.35|<0.0001
71104741|NCT01098747|141716677|SUPERIORITY_OR_OTHER||Difference in proportion|-59.28|||<|0.001|TWO_SIDED|95.0|-73.05|-45.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-45.50|-73.05|<0.001
71104742|NCT01098747|141716677|SUPERIORITY_OR_OTHER||Difference in proportion|1.56||||0.711|TWO_SIDED|95.0|-6.68|9.81||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.81|-6.68|0.711
71104743|NCT01098747|141716677|SUPERIORITY_OR_OTHER||Difference in proportion|-56.84|||<|0.001|TWO_SIDED|95.0|-70.84|-42.85||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-42.85|-70.84|<0.001
70930214|NCT03812614|141358600|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.06|TWO_SIDED|95.0|-1.0|0.01|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient healthy eating was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.01|-1.00|0.06
71049918|NCT02504671|141606195|OTHER||Mean Difference (Net)|-0.08||||0.358|TWO_SIDED|95.0|-0.26|0.09||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, HAQ-DI|||0.09|-0.26|0.358
71049919|NCT02504671|141606195|OTHER||Mean Difference (Net)|-0.09||||0.325|TWO_SIDED|95.0|-0.26|0.09||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, HAQ-DI|||0.09|-0.26|0.325
71049920|NCT02504671|141606195|OTHER||Mean Difference (Net)|-0.07||||0.473|TWO_SIDED|95.0|-0.28|0.13||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, HAQ-DI|||0.13|-0.28|0.473
71104744|NCT01098747|141716677|SUPERIORITY_OR_OTHER||Difference in proportion|3.72||||0.445|TWO_SIDED|95.0|-5.94|13.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.38|-5.94|0.445
70930215|NCT03812614|141358601|SUPERIORITY||Median Difference (Final Values)|-0.34||||0.45|TWO_SIDED|95.0|-1.22|0.54|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|||0.54|-1.22|0.45
71015922|NCT00077766|141539442|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with 90% power assuming that the true difference between the RO0503821 group and darbepoetin was not larger than 0.3 g/dL.|Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.1162|<|0.0001|TWO_SIDED|95.0|-0.049|0.408||The p-value for the non-inferiority test was derived using ANCOVA.|ANCOVA, CI for difference between groups|Degrees of Freedom : 246|Difference between groups based on the adjusted means derived from the ANCOVA model.|RO0503821 group was compared to darbepoetin alfa group, using analysis of covariance (ANCOVA) with the independent variable as treatment group and Hb at baseline and geographical region as covariates. The test for non-inferiority was based on the lower limit of 2-sided 95% confidence interval (CI) for difference in adjusted mean between 2 groups. If this lower limit was \> or = to -0.75 g/dL, the RO0503821 group was regarded as clinically non-inferior to darbepoetin alfa group, with 90% power.||0.408|-0.049|< 0.0001
71015923|NCT02181075|141539459|SUPERIORITY|||||||0.024||||||Not adjusted for multiple comparisons. A priori threshold \< 0.05|t-test, 2 sided|95% confidence interval (CI)||A paired t-test was used for Part I (Arm 1) only. Analysis only applies to Part I (Arm 1) because only this study arm has matched Post-LTLD (i.e. post-drug alone) and Post-LTLD+FUS biopsy samples obtained from the same liver tumours before and after targeted drug delivery. In Part II of the study design in which drug delivery occurred completely non-invasively, no Post-LTLD tissue sample is obtained and only a single tumour biopsy is obtained following drug delivery (Post-LTLD+FUS).||||0.024
71015924|NCT04150107|141539465|OTHER|Treatment least squares means and change from baseline estimates will be derived using this linear model.|Least mean squares||||<|0.9223|||||||ANCOVA|||Information collected in the daily diaries or via the Continuous Glucose Monitor (CGM) on the final 10 days of treatment will be analyzed using a Repeated Measures Analysis of Covariance with subject as a random effect with each of the 10 days being a single measurement. When analyzing the exogenous insulin variables, the CGM parameters (mean 24 hour glucose value and 24 hour time within 70-180 mg/dL range) and the patient reported carbohydrate intake will be included as covariates.||||<0.9223
71015925|NCT04150107|141539466|OTHER|Treatment least squares means and change from baseline estimates will be derived using this linear model.|||||<|0.8871|||||||ANCOVA|||Information collected in the daily diaries or via the Continuous Glucose Monitor (CGM) on the final 10 days of treatment will be analyzed using a Repeated Measures Analysis of Covariance with subject as a random effect with each of the 10 days being a single measurement. When analyzing the exogenous insulin variables, the CGM parameters (mean 24 hour glucose value and 24 hour time within 70-180 mg/dL range) and the patient reported carbohydrate intake will be included as covariates.||||<0.8871
71015926|NCT04150107|141539467|OTHER|Treatment least squares means and change from baseline estimates will be derived using this linear model.|||||<|0.9641|||||||ANCOVA|||Information collected in the daily diaries or via the Continuous Glucose Monitor (CGM) on the final 10 days of treatment will be analyzed using a Repeated Measures Analysis of Covariance with subject as a random effect with each of the 10 days being a single measurement. When analyzing the exogenous insulin variables, the CGM parameters (mean 24 hour glucose value and 24 hour time within 70-180 mg/dL range) and the patient reported carbohydrate intake will be included as covariates.||||<0.9641
70930216|NCT03812614|141358602|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.4|TWO_SIDED|95.0|-0.86|0.35|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient diabetes medication adherence was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.35|-0.86|0.40
71015927|NCT04150107|141539468|OTHER|Treatment least squares means and change from baseline estimates will be derived using this linear model.|||||<|0.7922|||||||ANCOVA|||Information collected in the daily diaries or via the Continuous Glucose Monitor (CGM) on the final 10 days of treatment will be analyzed using a Repeated Measures Analysis of Covariance with subject as a random effect with each of the 10 days being a single measurement. When analyzing the exogenous insulin variables, the CGM parameters (mean 24 hour glucose value and 24 hour time within 70-180 mg/dL range) and the patient reported carbohydrate intake will be included as covariates.||||<0.7922
71049921|NCT02504671|141606195|OTHER||Mean Difference (Net)|-0.18||||0.085|TWO_SIDED|95.0|-0.38|0.02||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, HAQ-DI|||0.02|-0.38|0.085
71049922|NCT02504671|141606195|OTHER||Mean Difference (Net)|0.01||||0.897|TWO_SIDED|95.0|-0.2|0.23||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, HAQ-DI|||0.23|-0.20|0.897
70930217|NCT03812614|141358602|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.98|TWO_SIDED|95.0|-0.9|0.88|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient blood pressure medication adherence (days/week meds were taken) was analyzed in a manner similar to that described for the primary outcome (6month change in patient A1c). Analyses were ITT and thus based on data from all enrolled patients.||0.88|-0.90|0.98
70930218|NCT03812614|141358602|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.43|TWO_SIDED|95.0|-1.42|0.61|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient cholesterol medication adherence (days/week meds were taken) was analyzed in a manner similar to that described for the primary outcome (6month change in patient A1c). Analyses were ITT and thus based on data from all enrolled patients.||0.61|-1.42|0.43
70930219|NCT03812614|141358603|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.06|TWO_SIDED|95.0|-1.0|0.01|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|||0.01|-1.00|0.06
70930220|NCT03812614|141358604|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.92|TWO_SIDED|95.0|-7.22|6.49|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient activation was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||6.49|-7.22|0.92
70930221|NCT03812614|141358605|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.02|TWO_SIDED|95.0|0.21|1.99|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient satisfaction with SP support was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||1.99|0.21|0.02
70930222|NCT03812614|141358606|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.06|TWO_SIDED|95.0|-0.01|0.7|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient perception of supportive and non-supportive behaviors was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.70|-0.01|0.06
70930223|NCT03812614|141358607|SUPERIORITY||Mean Difference (Final Values)|1.19||||0.49|TWO_SIDED|95.0|-2.19|4.57|||Mixed Models Analysis|||Support Persons (SPs) were surveyed twice, once at baseline and again at the end of their participation in the study. For SPs enrolled before the start of the COVID-19 pandemic (n=77), the follow-up survey was conducted at 12 months. Due to factors related to the pandemic, the length of the protocol was reduced from 12 to 6 months. Thus, SPs enrolled after the pandemic started (n=145) received their follow-up survey at 6 months, and 6-month change was used for predetermined SP outcomes.|Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|4.57|-2.19|0.49
70930224|NCT03812614|141358608|SUPERIORITY||Mean Difference (Final Values)|0.78||||0.08|TWO_SIDED|95.0|-0.09|1.66|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Support Persons (SPs) were surveyed twice, once at baseline and again at the end of their participation in the study. For SPs enrolled before the start of the COVID-19 pandemic (n=77), the follow-up survey was conducted at 12 months. Due to factors related to the pandemic, the length of the protocol was reduced from 12 to 6 months. Thus, SPs enrolled after the pandemic started (n=145) received their follow-up survey at 6 months, and 6-month change was used for predetermined SP outcomes.||1.66|-0.09|0.08
70930225|NCT04763772|141358623|SUPERIORITY||Mean Difference (Final Values)|-4.5||||0.2|TWO_SIDED|95.0|-14.0|4.8|||Regression, Linear|||||4.8|-14|0.2
70930226|NCT00450216|141358633|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|9.8|||<|0.0001|TWO_SIDED|95.0|4.4|15.3||CMH test stratified by use of low-dose aspirin (yes/no) and prior upper gastrointestinal (UGI) ulcer history (yes/no) at randomization.|Cochran-Mantel-Haenszel|||The primary efficacy endpoint was the number of participants developing gastric ulcers throughout 24 weeks of treatment. A summary, including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of gastric ulcers at 24 weeks. The cumulative number of participants developing gastric ulcers at 24 weeks was analyzed using the Cochran-Mantel-Haenszel (CMH) test stratified by use of low-dose aspirin and prior UGI ulcer history.||15.3|4.4|<0.0001
71015928|NCT04150107|141539469|OTHER|Treatment least squares means and change from baseline estimates will be derived using this linear model.|||||<|0.9898|||||||ANCOVA|||Information collected in the daily diaries or via the Continuous Glucose Monitor (CGM) on the final 10 days of treatment will be analyzed using a Repeated Measures Analysis of Covariance with subject as a random effect with each of the 10 days being a single measurement. When analyzing the exogenous insulin variables, the CGM parameters (mean 24 hour glucose value and 24 hour time within 70-180 mg/dL range) and the patient reported carbohydrate intake will be included as covariates.||||<0.9898
71049923|NCT02504671|141606195|OTHER||Mean Difference (Net)|-0.2||||0.065|TWO_SIDED|95.0|-0.42|0.01||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, HAQ-DI|||0.01|-0.42|0.065
71049924|NCT02504671|141606195|OTHER||Mean Difference (Net)|-0.14||||0.238|TWO_SIDED|95.0|-0.36|0.09||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, HAQ-DI|||0.09|-0.36|0.238
71049925|NCT02504671|141606195|OTHER||Mean Difference (Net)|-0.21||||0.071|TWO_SIDED|95.0|-0.44|0.02||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, HAQ-DI|||0.02|-0.44|0.071
71049926|NCT02504671|141606195|OTHER||Mean Difference (Net)|-0.12||||0.34|TWO_SIDED|95.0|-0.38|0.13||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, HAQ-DI|||0.13|-0.38|0.340
71049927|NCT02504671|141606195|OTHER||Mean Difference (Net)|-0.24||||0.059|TWO_SIDED|95.0|-0.49|0.01||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, HAQ-DI|||0.01|-0.49|0.059
71049928|NCT02504671|141606195|OTHER||Mean Difference (Net)|0.09||||0.607|TWO_SIDED|95.0|-0.26|0.44||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, HAQ-DI|||0.44|-0.26|0.607
71049929|NCT02504671|141606195|OTHER||Mean Difference (Net)|-0.01||||0.959|TWO_SIDED|95.0|-0.34|0.32||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, HAQ-DI|||0.32|-0.34|0.959
71049930|NCT02504671|141606195|OTHER||Mean Difference (Net)|-0.15||||0.401|TWO_SIDED|95.0|-0.49|0.2||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, HAQ-DI|||0.20|-0.49|0.401
71049931|NCT02504671|141606195|OTHER||Mean Difference (Net)|-0.21||||0.207|TWO_SIDED|95.0|-0.54|0.12||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, HAQ-DI|||0.12|-0.54|0.207
71049932|NCT02504671|141606195|OTHER||Mean Difference (Net)|-0.08||||0.637|TWO_SIDED|95.0|-0.44|0.27||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, HAQ-DI|||0.27|-0.44|0.637
71049933|NCT02504671|141606195|OTHER||Mean Difference (Final Values)|-0.2||||0.251|TWO_SIDED|95.0|-0.53|0.14||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, HAQ-DI|||0.14|-0.53|0.251
71049934|NCT02504671|141606196|OTHER||Mean Difference (Net)|-2.45||||0.511|TWO_SIDED|95.0|-9.81|4.9||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, Pain score|||4.90|-9.81|0.511
71049935|NCT02504671|141606196|OTHER||Mean Difference (Net)|-2.76||||0.461|TWO_SIDED|95.0|-10.13|4.6||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, Pain score|||4.60|-10.13|0.461
71049936|NCT02504671|141606196|OTHER||Mean Difference (Net)|-7.71||||0.039|TWO_SIDED|95.0|-15.03|-0.39||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, Pain score|||-0.39|-15.03|0.039
71049937|NCT02504671|141606196|OTHER||Mean Difference (Net)|-2.92||||0.469|TWO_SIDED|95.0|-10.86|5.01||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, Pain score|||5.01|-10.86|0.469
71049938|NCT02504671|141606196|OTHER||Mean Difference (Net)|-5.99||||0.133|TWO_SIDED|95.0|-13.82|1.85||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, Pain score|||1.85|-13.82|0.133
71049939|NCT02504671|141606196|OTHER||Mean Difference (Net)|-7.58||||0.057|TWO_SIDED|95.0|-15.4|0.23||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, Pain score|||0.23|-15.40|0.057
71049940|NCT02504671|141606196|OTHER||Mean Difference (Net)|-3.03||||0.49|TWO_SIDED|95.0|-11.67|5.61||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Pain score|||5.61|-11.67|0.490
71049941|NCT02504671|141606196|OTHER||Mean Difference (Net)|-9.38||||0.031|TWO_SIDED|95.0|-17.91|-0.86||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Pain score|||-0.86|-17.91|0.031
71049942|NCT02504671|141606196|OTHER||Mean Difference (Net)|-12.21||||0.005|TWO_SIDED|95.0|-20.67|-3.74||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Pain score|||-3.74|-20.67|0.005
71049943|NCT02504671|141606196|OTHER||Mean Difference (Net)|-4.49||||0.345|TWO_SIDED|95.0|-13.83|4.85||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, Pain score|||4.85|-13.83|0.345
71049944|NCT02504671|141606196|OTHER||Mean Difference (Net)|-8.02||||0.09|TWO_SIDED|95.0|-17.3|1.26||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, Pain score|||1.26|-17.30|0.090
71049945|NCT02504671|141606196|OTHER||Mean Difference (Net)|-8.36||||0.074|TWO_SIDED|95.0|-17.55|0.83||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, Pain score|||0.83|-17.55|0.074
71015929|NCT04150107|141539470|OTHER|Treatment least squares means and change from baseline estimates will be derived using this linear model.|||||<|0.5165|||||||ANCOVA|||Information collected in the daily diaries or via the Continuous Glucose Monitor (CGM) on the final 10 days of treatment will be analyzed using a Repeated Measures Analysis of Covariance with subject as a random effect with each of the 10 days being a single measurement. When analyzing the exogenous insulin variables, the CGM parameters (mean 24 hour glucose value and 24 hour time within 70-180 mg/dL range) and the patient reported carbohydrate intake will be included as covariates.||||<0.5165
71015930|NCT03539952|141539508|NON_INFERIORITY|The primary efficacy analysis utilized the serum NCC values from all study visits that were analyzed using a restricted maximum likelihood based general linear model for correlated data. The correlation due to repeated measures was modeled by specifying the variance covariance matrix. Considering a comparison of means in both treatment arms (D-penicillamine minus TETA 4HCl) at the 1-sided 2.5% level of Type 1 error, a non-inferiority margin of 50 μg/L was used.|Mean Difference (Final Values)|-9.2|STANDARD_ERROR_OF_MEAN|7.49|||TWO_SIDED|||||||||The primary endpoint was the assessment of the non-inferiority of TETA 4HCl in relation to D-penicillamine. The non-inferiority assessment was made on the basis of the mean serum NCC level at Week 36.||||
71015931|NCT02087865|141539513|SUPERIORITY||Mean Difference (Final Values)|-8.25|STANDARD_ERROR_OF_MEAN|7.59||0.273|TWO_SIDED|95.0|-23.12|6.63|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||6.63|-23.12|0.273
71015932|NCT02087865|141539514|SUPERIORITY||Mean Difference (Final Values)|-13.41|STANDARD_ERROR_OF_MEAN|3.92||0.001|TWO_SIDED|95.0|-21.09|-5.73|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||-5.73|-21.09|0.001
71015933|NCT02087865|141539515|SUPERIORITY||Median Difference (Final Values)|-8.6|STANDARD_ERROR_OF_MEAN|5.48||0.115|TWO_SIDED|95.0|-19.33|2.14|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||2.14|-19.33|0.115
71015934|NCT02087865|141539516|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|2.09||0.941|TWO_SIDED|95.0|-3.94|4.25|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||4.25|-3.94|0.941
71015935|NCT02087865|141539517|SUPERIORITY||Mean Difference (Final Values)|46.33|STANDARD_ERROR_OF_MEAN|15.4||0.003|TWO_SIDED|95.0|16.14|76.53|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||76.53|16.14|0.003
71015936|NCT02087865|141539518|SUPERIORITY||Mean Difference (Final Values)|61.36|STANDARD_ERROR_OF_MEAN|13.32|<|0.001|TWO_SIDED|95.0|35.25|87.46|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||87.46|35.25|<0.001
71049946|NCT02504671|141606196|OTHER||Mean Difference (Net)|-5.61||||0.268|TWO_SIDED|95.0|-15.57|4.34||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, Pain score|||4.34|-15.57|0.268
71049947|NCT02504671|141606196|OTHER||Mean Difference (Net)|-14.57||||0.004|TWO_SIDED|95.0|-24.43|-4.7||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, Pain score|||-4.70|-24.43|0.004
71049948|NCT02504671|141606196|OTHER||Mean Difference (Net)|-13.94||||0.005|TWO_SIDED|95.0|-23.72|-4.16||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, Pain score|||-4.16|-23.72|0.005
71049949|NCT02504671|141606196|OTHER||Mean Difference (Net)|-7.02||||0.182|TWO_SIDED|95.0|-17.36|3.32||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Pain score|||3.32|-17.36|0.182
71015937|NCT02087865|141539519|SUPERIORITY||Mean Difference (Final Values)|-3.35|STANDARD_ERROR_OF_MEAN|1.18||0.005|TWO_SIDED|95.0|-5.65|-1.04|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||-1.04|-5.65|0.005
71049950|NCT02504671|141606196|OTHER||Mean Difference (Net)|-14.15||||0.007|TWO_SIDED|95.0|-24.42|-3.87||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Pain score|||-3.87|-24.42|0.007
71015938|NCT02087865|141539520|SUPERIORITY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|1.67||0.011|TWO_SIDED|95.0|-7.58|-1.02|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||-1.02|-7.58|0.011
71015939|NCT01392469|141539529|SUPERIORITY||Ratio (Test/Reference)|1.17|||||TWO_SIDED|90.0|1.03|1.33||||||||1.33|1.03|
71015940|NCT01392469|141539529|SUPERIORITY||Ratio (Test/Reference)|1.4|||||TWO_SIDED|90.0|1.23|1.59||||||||1.59|1.23|
71049951|NCT02504671|141606196|OTHER||Mean Difference (Net)|-18.18|||<|0.001|TWO_SIDED|95.0|-28.35|-8.01||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Pain score|||-8.01|-28.35|<0.001
71049952|NCT02504671|141606196|OTHER||Mean Difference (Net)|-4.89||||0.527|TWO_SIDED|95.0|-20.15|10.36||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, Pain score|||10.36|-20.15|0.527
71104745|NCT01098747|141716677|SUPERIORITY_OR_OTHER||Difference in proportion|-52.79|||<|0.001|TWO_SIDED|95.0|-66.77|-38.81||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-38.81|-66.77|<0.001
71015941|NCT01392469|141539530|SUPERIORITY||Ratio (Test/Reference)|1.36|||||TWO_SIDED|90.0|1.14|1.62||||||||1.62|1.14|
71015942|NCT01392469|141539530|SUPERIORITY||Ratio (Test/Reference)|1.7|||||TWO_SIDED|90.0|1.43|2.03||||||||2.03|1.43|
71015943|NCT01392469|141539531|SUPERIORITY||Ratio (Test/Reference)|1.0|||||TWO_SIDED|90.0|0.82|1.21||||||||1.21|0.82|
71015944|NCT01392469|141539531|SUPERIORITY||Ratio (Test/Reference)|1.07|||||TWO_SIDED|90.0|0.88|1.31||||||||1.31|0.88|
71015945|NCT01392469|141539532|SUPERIORITY||Ratio (Test/Reference)|1.28|||||TWO_SIDED|90.0|1.03|1.61||||||||1.61|1.03|
71015946|NCT01392469|141539532|SUPERIORITY||Ratio (Test/Reference)|1.56|||||TWO_SIDED|90.0|1.24|1.95||||||||1.95|1.24|
71015947|NCT00684645|141539594|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.395|||<|0.0001|TWO_SIDED|95.0|0.257|0.609|||Cox proportional hazard|||Time to PFS was analyzed using survival analysis methodology. Model was fitted with sunitinib-induced hypertension included as a time-dependent covariate (presence versus absence of hypertension).||0.609|0.257|<0.0001
71015948|NCT00684645|141539595|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.361||||0.0221|TWO_SIDED|95.0|0.151|0.864|||Cox proportional hazard|||Time to OS was analyzed using survival analysis methodology. Model was fitted with sunitinib-induced hypertension included as a time-dependent covariate (presence versus absence of hypertension).||0.864|0.151|0.0221
71015949|NCT03126682|141539606|SUPERIORITY|||||||0.212||||||Threshold of \<0.05|t-test, 2 sided|||||||0.212
71015950|NCT02074982|141539615|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.85|||<|0.0001|TWO_SIDED|95.0|2.01|4.02|||Regression, Logistic|||||4.02|2.01|<0.0001
71015951|NCT02513095|141539627|SUPERIORITY||Odds Ratio (OR)|6.0||||0.396|TWO_SIDED|95.0|0.6|76.8|||Chi-squared, Corrected|||||76.8|0.6|0.396
71015952|NCT00798707|141539631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.452|TWO_SIDED|95.0|-0.75|1.69||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|ANCOVA|||An analysis of covariance (ANCOVA) model with treatment and as a factor and the baseline HAM-D17 total score as a covariate was used to compare each DVS SR dose to placebo. The comparison was performed at the 0.05 level overall.||1.69|-0.75|0.452
71015953|NCT00798707|141539631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.016|TWO_SIDED|95.0|0.28|2.72||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|ANCOVA|||An analysis of covariance (ANCOVA) model with treatment and as a factor and the baseline HAM-D17 total score as a covariate was used to compare each DVS SR dose to placebo. The comparison was performed at the 0.05 level overall.||2.72|0.28|0.016
71015954|NCT00798707|141539632|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED|||||In this case, multiplicity arising from testing key secondary hypotheses in both doses was controlled by a Hochberg step-up procedure. p-Value obtained for the alternative hypothesis of 'Row mean scores differences'.|Cochran-Mantel-Haenszel|||Each DVS SR dose was separately compared to placebo. To control the study-wise type I error rate across the primary and the key secondary endpoints, as well as across the 2 active dose arms, testing of the key secondary hypothesis occurred only when both active doses were superior to placebo on the primary endpoint.||||0.160
71015955|NCT00798707|141539632|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED|||||In this case, multiplicity arising from testing key secondary hypotheses in both doses was controlled by a Hochberg step-up procedure.p-Value obtained for the alternative hypothesis of 'Row mean scores differences'.|Cochran-Mantel-Haenszel|||Each DVS SR dose was separately compared to placebo. To control the study-wise type I error rate across the primary and the key secondary endpoints, as well as across the 2 active dose arms, testing of the key secondary hypothesis occurred only when both active doses were superior to placebo on the primary endpoint.||||0.028
71015956|NCT00798707|141539633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.066|TWO_SIDED|95.0|-0.01|0.39|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.39|-0.01|0.066
71015957|NCT00798707|141539633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.038|TWO_SIDED|95.0|0.01|0.41|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.41|0.01|0.038
71015958|NCT00798707|141539634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.242|TWO_SIDED|95.0|-0.68|2.68|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||2.68|-0.68|0.242
71015959|NCT00798707|141539634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.06||||0.016|TWO_SIDED|95.0|0.39|3.73|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||3.73|0.39|0.016
71015960|NCT00798707|141539635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.802|TWO_SIDED|95.0|-0.62|0.8|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.80|-0.62|0.802
71015961|NCT00798707|141539635|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.72||||0.048|TWO_SIDED|95.0|0.01|1.43|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||1.43|0.01|0.048
71015962|NCT00798707|141539636|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.363||||0.1099|TWO_SIDED|95.0|0.93|1.99|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||1.99|0.93|0.1099
71015963|NCT00798707|141539636|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.591||||0.0154|TWO_SIDED|95.0|1.09|2.32|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||2.32|1.09|0.0154
71015964|NCT00798707|141539637|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.878||||0.5929|TWO_SIDED|95.0|0.54|1.41|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||1.41|0.54|0.5929
71015965|NCT00798707|141539637|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.474||||0.0852|TWO_SIDED|95.0|0.95|2.29|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||2.29|0.95|0.0852
71015966|NCT00798707|141539638|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.277||||0.2232|TWO_SIDED|95.0|0.86|1.89|||Regression, Logistic|||Analysis was conducted with a logistic regression model with treatment as a factor and baseline MADRS score as a covariate.||1.89|0.86|0.2232
71015967|NCT00798707|141539638|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.827||||0.0022|TWO_SIDED|95.0|1.24|2.69|||Regression, Logistic|||Analysis was conducted with a logistic regression model with treatment as a factor and baseline MADRS score as a covariate.||2.69|1.24|0.0022
70930227|NCT00450216|141358634|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.8|||<|0.0001|TWO_SIDED|95.0|6.1|17.6||CMH test stratified by use of low-dose aspirin (yes/no) and prior UGI ulcer history (yes/no) at randomization.|Cochran-Mantel-Haenszel|||The secondary efficacy endpoint was the number of participants developing UGI (i.e., gastric and/or duodenal) ulcers throughout 24 weeks of treatment. A summary, including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of UGI ulcers at 24 weeks. The cumulative number of participants developing UGI ulcers at 24 weeks was analyzed using the CMH test stratified by use of low-dose aspirin and prior UGI ulcer history.||17.6|6.1|<0.0001
70930228|NCT00450216|141358635|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|3.8||||0.0006|TWO_SIDED|95.0|1.0|6.8||CMH test stratified by use of low-dose aspirin (yes/no) and prior UGI ulcer history (yes/no) at randomization.|Cochran-Mantel-Haenszel|||The secondary efficacy endpoint was the number of participants developing duodenal ulcers throughout 24 weeks of treatment. A summary, including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of duodenal ulcers at 24 weeks. The cumulative number of participants developing duodenal ulcers at 24 weeks was analyzed using the CMH test stratified by use of low-dose aspirin and prio UGI ulcer history at randomization.||6.8|1.0|0.0006
71015968|NCT00798707|141539639|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.158||||0.4313|TWO_SIDED|95.0|0.8|1.67|||Regression, Logistic|||Analysis was conducted with a logistic regression model with treatment as a factor.||1.67|0.80|0.4313
71015969|NCT00798707|141539639|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.372||||0.0888|TWO_SIDED|95.0|0.95|1.97|||Regression, Logistic|||Analysis was conducted with a logistic regression model with treatment as a factor.||1.97|0.95|0.0888
71015970|NCT00798707|141539641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.09||||0.073|TWO_SIDED|95.0|-0.1|2.29|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for total score.||2.29|-0.10|0.073
71015971|NCT00798707|141539641|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.06||||0.078|TWO_SIDED|95.0|-0.12|2.24|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for total score.||2.24|-0.12|0.078
71049953|NCT02504671|141606196|OTHER||Mean Difference (Net)|-15.95||||0.034|TWO_SIDED|95.0|-30.72|-1.19||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, Pain score|||-1.19|-30.72|0.034
71049954|NCT02504671|141606196|OTHER||Mean Difference (Net)|-13.86||||0.062|TWO_SIDED|95.0|-28.42|0.7||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, Pain score|||0.70|-28.42|0.062
71049955|NCT02504671|141606196|OTHER||Mean Difference (Net)|-0.69||||0.924|TWO_SIDED|95.0|-14.85|13.47||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, Pain score|||13.47|-14.85|0.924
71049956|NCT02504671|141606196|OTHER||Mean Difference (Net)|-13.17||||0.058|TWO_SIDED|95.0|-26.82|0.48||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, Pain score|||0.48|-26.82|0.058
71049957|NCT02504671|141606196|OTHER||Mean Difference (Net)|-13.49||||0.049|TWO_SIDED|95.0|-26.91|-0.08||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, Pain score|||-0.08|-26.91|0.049
71049958|NCT02504671|141606196|OTHER||Mean Difference (Net)|-6.38||||0.445|TWO_SIDED|95.0|-22.84|10.07||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Pain score|||10.07|-22.84|0.445
71049959|NCT02504671|141606196|OTHER||Mean Difference (Net)|-10.14||||0.205|TWO_SIDED|95.0|-25.87|5.58||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Pain score|||5.58|-25.87|0.205
71049960|NCT02504671|141606196|OTHER||Mean Difference (Net)|-12.07||||0.125|TWO_SIDED|95.0|-27.55|3.41||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Pain score|||3.41|-27.55|0.125
71049961|NCT02504671|141606196|OTHER||Mean Difference (Net)|-4.93||||0.187|TWO_SIDED|95.0|-12.26|2.41||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, Pain score|||2.41|-12.26|0.187
71049962|NCT02504671|141606196|OTHER||Mean Difference (Net)|-5.63||||0.13|TWO_SIDED|95.0|-12.93|1.67||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, Pain score|||1.67|-12.93|0.130
70850655|NCT00843284|141189480|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.02|STANDARD_DEVIATION|2.9|<|0.0001||95.0|-4.24|-3.8|||t-test, 2 sided|One sample t-test.||Change from baseline||-3.80|-4.24|<0.0001
71015972|NCT00798707|141539641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.176|TWO_SIDED|95.0|-0.13|0.73|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for work/studies component score.||0.73|-0.13|0.176
70850656|NCT00147069|141189483|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||||||0.1
71049963|NCT02504671|141606196|OTHER||Mean Difference (Net)|-7.85||||0.051|TWO_SIDED|95.0|-15.72|0.03||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, Pain score|||0.03|-15.72|0.051
70930229|NCT04099732|141358666|OTHER||Ratio of geometric means (T/R) %|183.36|||||TWO_SIDED|90.0|164.35|204.56|||||Geometric coefficient of variation (gCV) = 16.5.|Relative bioavailability. The statistical model was an ANOVA model on the logarithmic scale, considering the effects 'subjects' as random and 'treatment' as fixed.||204.56|164.35|
70930230|NCT04099732|141358667|OTHER||Ratio of geometric means (T/R) %|174.01|||||TWO_SIDED|90.0|154.73|195.68|||||Geometric coefficient of variation (gCV) = 17.7|Relative bioavailability. The statistical model was an ANOVA model on the logarithmic scale, considering the effects 'subjects' as random and 'treatment' as fixed.||195.68|154.73|
70930231|NCT04099732|141358668|OTHER||Ratio of geometric means (T/R) %|119.1|||||TWO_SIDED|90.0|109.84|129.15|||||Geometric coefficient of variation (gCV) = 11.1.|Relative Bioavailability. The statistical model was an ANOVA model on the logarithmic scale, considering the effects 'subjects' as random and 'treatment' as fixed.||129.15|109.84|
70930232|NCT04099732|141358669|OTHER||Ratio of geometric means (T/R) %|119.2|||||TWO_SIDED|90.0|107.68|131.94|||||Geometric coefficient of variation (gCV) = 13.9.|Relative Bioavailability. The statistical model was an ANOVA model on the logarithmic scale, considering the effects 'subjects' as random and 'treatment' as fixed.||131.94|107.68|
70930233|NCT04099732|141358670|OTHER||Ratio of geometric means (T/R) %|186.38|||||TWO_SIDED|90.0|169.7|204.71|||||Geometric coefficient of variation (gCV) = 14.1.|Relative Bioavailability. The statistical model was an ANOVA model on the logarithmic scale, considering the effects 'subjects' as random and 'treatment' as fixed.||204.71|169.70|
70930234|NCT04099732|141358671|OTHER||Ratio of geometric means (T/R) %|120.11|||||TWO_SIDED|90.0|110.78|130.23|||||Geometric coefficient of variation (gCV) = 11.1|Relative Bioavailability. The statistical model was an ANOVA model on the logarithmic scale, considering the effects 'subjects' as random and 'treatment' as fixed.||130.23|110.78|
71015973|NCT00798707|141539641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.109|TWO_SIDED|95.0|-0.08|0.77|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for work/studies component score.||0.77|-0.08|0.109
71015974|NCT00798707|141539641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.064|TWO_SIDED|95.0|-0.02|0.84|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for social life component score.||0.84|-0.02|0.064
71015975|NCT00798707|141539641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.104|TWO_SIDED|95.0|-0.07|0.78|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for social life component score.||0.78|-0.07|0.104
70930235|NCT05123027|141358672|SUPERIORITY||Risk Ratio (RR)|0.7||||0.399|TWO_SIDED|95.0|0.3|1.62||Threshold for significance: p\< 0.05|Mixed Models Analysis|||The primary outcome was analyzed with a longitudinal mixed effects negative binomial model incorporating the total score at earlier time points as well as 180 days. Fixed effect covariates included baseline score, treatment, days, site, stratum, and an interaction between treatment and days. A random effect was included to account for correlation within each participant.||1.62|0.30|0.399
71015976|NCT00798707|141539641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29||||0.538|TWO_SIDED|95.0|-2.98|5.57|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for family life/home responsibilities component score.||5.57|-2.98|0.538
71015977|NCT00798707|141539641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43||||0.689|TWO_SIDED|95.0|-1.76|2.62|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for family life/home responsibilities component score||2.62|-1.76|0.689
71015978|NCT00798707|141539642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81||||0.066|TWO_SIDED|95.0|-1.67|0.05|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.05|-1.67|0.066
71049964|NCT02504671|141606196|OTHER||Mean Difference (Net)|-10.44||||0.009|TWO_SIDED|95.0|-18.27|-2.6||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, Pain score|||-2.60|-18.27|0.009
70930236|NCT05123027|141358673|SUPERIORITY||Risk Ratio (RR)|1.09||||0.53|TWO_SIDED|95.0|0.83|1.45||Threshold for significance: p\< 0.05|Mixed Models Analysis|||This was modeled similar to the primary outcome, an over dispersed Poisson regression model with fixed effect covariates for treatment arm, treatment days, site, and stratum with an interaction between treatment arm and treatment days. Note that no baseline score covariate was included as all participants will be considered to have achieved 0 steps at baseline. A random intercept was included for each subject to account for repeated measures.||1.45|0.83|0.53
70930237|NCT03735979|141358674|SUPERIORITY||Posterior Mean Difference (Final Values)|-1.51|STANDARD_DEVIATION|0.51||0.002|TWO_SIDED|||||"The P-value is the posterior probability that study drug has a higher benefit than control. The a priori threshold for a successful trial is 0.985.~The posterior probability that argatroban was better than placebo was 0.002."|Bayesian|Primary analysis compared treatment group with placebo, with adjustment for baseline NIHSS score in a Bayesian normal dynamic linear model.|The posterior mean of study treatment minus placebo.|||||0.002
70930238|NCT03735979|141358674|SUPERIORITY||Posterior Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|0.29||0.04|TWO_SIDED|||||"The P-value is the posterior probability that study drug has a higher benefit than control. The a priori threshold for a successful trial is 0.985.~The posterior probability that eptifibitide was better than placebo was 0.04."|Bayesian|Primary analysis compared treatment group with placebo, with adjustment for baseline NIHSS score in a Bayesian normal dynamic linear model.|The posterior mean of study treatment minus placebo.|||||0.04
70930239|NCT05654662|141358706|SUPERIORITY|||||||0.0032|||||||MMRM|||Change from Baseline at Week 12 (Test for non-zero within group change from Baseline)||||0.0032
71015979|NCT00798707|141539642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63||||0.15|TWO_SIDED|95.0|-1.48|0.23|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.23|-1.48|0.150
71015980|NCT00798707|141539643|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.951||||0.8758|TWO_SIDED|95.0|0.51|1.78|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment and gender as factors and baseline sexual dysfunction status as a covariate.||1.78|0.51|0.8758
70930240|NCT05654662|141358707|SUPERIORITY||Adjusted Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|2.03||0.0013|TWO_SIDED|95.0|-10.6|-2.6|||Mixed Model with Repeated Measure (MMRM)||Adjusted mean difference was calculated as test product minus reference product.|||-2.6|-10.6|0.0013
70930241|NCT05654662|141358708|SUPERIORITY|||||||0.0181|||||||MMRM|||Change from Baseline at Week 3 (Test for non-zero within group change from Baseline)||||0.0181
70930242|NCT05654662|141358708|SUPERIORITY|||||||0.0541|||||||MMRM|||Change from Baseline at Week 6 (Test for non-zero within group change from Baseline)||||0.0541
70930243|NCT05654662|141358709|SUPERIORITY||Adjusted Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|1.44||0.0091|TWO_SIDED|95.0|-6.7|-1.0|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-1.0|-6.7|0.0091
70930244|NCT05654662|141358709|SUPERIORITY||Adjusted Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|1.78||0.0031|TWO_SIDED|95.0|-8.8|-1.8|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-1.8|-8.8|0.0031
70930245|NCT05654662|141358710|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 3 (Test for non-zero within group change from Baseline)||||<0.0001
70930246|NCT05654662|141358710|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 6 (Test for non-zero within group change from Baseline)||||<0.0001
71015981|NCT00798707|141539643|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.165||||0.6397|TWO_SIDED|95.0|0.61|2.21|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment and gender as factors and baseline sexual dysfunction status as a covariate.||2.21|0.61|0.6397
71015982|NCT00798707|141539645|SUPERIORITY_OR_OTHER|||||||0.847|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 8 (or ET).||||0.847
71015983|NCT00798707|141539645|SUPERIORITY_OR_OTHER|||||||0.847|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 8 (or ET).||||0.847
70850657|NCT00147069|141189484|SUPERIORITY|||||||0.05||||||The reported p value was calculated|Kruskal-Wallis|||||||0.05
71015984|NCT00798707|141539645|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 9 (or ET + 1 week).||||0.720
71015985|NCT00798707|141539645|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 9 (or ET + 1 week).||||0.720
70850658|NCT00147069|141189485|SUPERIORITY|||||||0.05|||||||Kruskal-Wallis|||||||0.05
70850659|NCT00147069|141189486|SUPERIORITY|||||||0.05|||||||Kruskal-Wallis|||||||0.05
70850660|NCT02160899|141189546|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
70850661|NCT02160899|141189546|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
70850662|NCT02160899|141189546|SUPERIORITY|||||||0.044|||||||Exact Wilcoxon Rank Sum Test|||||||0.044
70930247|NCT05654662|141358710|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 12 (Test for non-zero within group change from Baseline)||||<0.0001
70930248|NCT05654662|141358711|SUPERIORITY||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.011||0.0051|TWO_SIDED|95.0|-0.05|-0.01|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.01|-0.05|0.0051
70930249|NCT05654662|141358711|SUPERIORITY||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.013||0.0034|TWO_SIDED|95.0|-0.07|-0.01|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.01|-0.07|0.0034
70930250|NCT05654662|141358711|SUPERIORITY||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.015||0.0022|TWO_SIDED|95.0|-0.08|-0.02|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.02|-0.08|0.0022
70930251|NCT05654662|141358712|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 3 (Test for non-zero within group change from Baseline)||||<0.0001
70930252|NCT05654662|141358712|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 6 (Test for non-zero within group change from Baseline)||||<0.0001
70930253|NCT05654662|141358712|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 12 (Test for non-zero within group change from Baseline)||||<0.0001
70930254|NCT05654662|141358713|SUPERIORITY||Adjusted Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|-0.12|-0.04|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.04|-0.12|<0.0001
70930255|NCT05654662|141358713|SUPERIORITY||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|-0.18|-0.07|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.07|-0.18|<0.0001
70930256|NCT05654662|141358713|SUPERIORITY||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|-0.2|-0.08|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.08|-0.20|<0.0001
70930257|NCT05654662|141358714|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 3 (Test for non-zero within group change from Baseline)||||<0.0001
70930258|NCT05654662|141358714|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 6 (Test for non-zero within group change from Baseline)||||<0.0001
70930259|NCT05654662|141358714|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 12 (Test for non-zero within group change from Baseline)||||<0.0001
70930260|NCT05654662|141358715|SUPERIORITY||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.047||0.0012|TWO_SIDED|95.0|-0.25|-0.06|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.06|-0.25|0.0012
71015986|NCT00798707|141539645|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 10 (or ET + 2 weeks).||||0.720
71015987|NCT00798707|141539645|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 10 (or ET + 2 weeks).||||0.720
71015988|NCT03256526|141539684|SUPERIORITY||LS mean difference|11.45||||0.1654|TWO_SIDED|90.0|-2.19|25.09|||ANCOVA|||||25.09|-2.19|0.1654
70930261|NCT05654662|141358715|SUPERIORITY||Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.061||0.0058|TWO_SIDED|95.0|-0.29|-0.05|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.05|-0.29|0.0058
70930262|NCT05654662|141358715|SUPERIORITY||Adjusted Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.42|-0.16|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.16|-0.42|<0.0001
70930263|NCT05654662|141358716|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 3 (Test for non-zero within group change from Baseline)||||<0.0001
70930264|NCT05654662|141358716|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 6 (Test for non-zero within group change from Baseline)||||<0.0001
70930265|NCT05654662|141358716|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 12 (Test for non-zero within group change from Baseline)||||<0.0001
70930266|NCT05654662|141358717|SUPERIORITY||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.051||0.0022|TWO_SIDED|95.0|-0.26|-0.06|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.06|-0.26|0.0022
70930267|NCT05654662|141358717|SUPERIORITY||Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.066||0.0099|TWO_SIDED|95.0|-0.3|-0.04|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.04|-0.30|0.0099
71015989|NCT03256526|141539684|SUPERIORITY||LS mean difference|-18.73||||0.0395|TWO_SIDED|90.0|-33.55|-3.9|||ANCOVA|||||-3.90|-33.55|0.0395
71015990|NCT00566969|141539695|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A hierarchical linear model was used to account for unequal variance and covariance structures across time.||||||0.1|||||||ANOVA|||||||.10
71015991|NCT02329834|141539750|EQUIVALENCE|90% Confidence Interval 80\<ratio of AUC\<125. The FDA guided Bioequivalence limit of 80 to 125% for the ratio of the product averages has been adopted for use of an average BE criterion.|% diff Geometric Least Squared Mean|99.5|||||TWO_SIDED|90.0|94.77|104.75||||||||104.75|94.77|
71015992|NCT02329834|141539751|OTHER||% Diff Geometric Least Squared Mean|99.65|||||TWO_SIDED|90.0|94.79|104.75||||||||104.75|94.79|
71015993|NCT00561600|141539777|NON_INFERIORITY_OR_EQUIVALENCE|non inferiority of proportion successful with 8% non inferiority margin at 24 months|percentage difference|0.139||||0.872|ONE_SIDED|95.0||0.225|||Chi-squared||The upper confidence limit was a priori determined to be a secondary endpoint|A non-inferiority test of the proportion successful for each treatment group will be the primary test of efficacy in this investigation. The null hypothesis is Ho: Xc-Xt ≥ 0.08 and the alternative hypothesis is HA:Xc-Xt \< 0.08 Sample size of 126 per group was needed assuming 93% success rates, this was increased to 150 per group to account for attrition.||.225||0.872
71015994|NCT00561600|141539778|SUPERIORITY_OR_OTHER|||||||0.167||95.0|||||t-test, 2 sided|Satterthwaite||||||0.167
70850663|NCT04518995|141189569|SUPERIORITY||Risk Difference (RD)|0.28|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.23|0.33||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.33|0.23|<0.0001
71015995|NCT00561600|141539781|SUPERIORITY_OR_OTHER|||||||0.457|||||||Wilcoxon (Mann-Whitney)|||||||0.457
71015996|NCT00561600|141539782|SUPERIORITY_OR_OTHER|||||||0.762|||||||Wilcoxon (Mann-Whitney)|||||||0.762
71015997|NCT00561600|141539783|SUPERIORITY_OR_OTHER|||||||0.869|||||||Wilcoxon (Mann-Whitney)|||||||0.869
71015998|NCT00561600|141539784|SUPERIORITY_OR_OTHER|||||||0.799|||||||Wilcoxon (Mann-Whitney)|||||||0.799
71015999|NCT00561600|141539785|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum cobalt ions were expected to be lower in the ASR-XL group||||<0.001
71016000|NCT00561600|141539786|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group||||0.032
71016001|NCT00561600|141539787|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group||||<0.001
71016002|NCT00561600|141539788|SUPERIORITY_OR_OTHER|||||||0.882|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group||||0.882
70930268|NCT05654662|141358717|SUPERIORITY||Adjusted Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.073|<|0.0001|TWO_SIDED|95.0|-0.45|-0.16|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.16|-0.45|<0.0001
70930269|NCT04499521|141358742|OTHER||Median Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.27|0.5||||||Mean difference between Gauze and Gel ARM A Bladder D2cc||0.50|-0.27|
70930270|NCT04499521|141358742|OTHER||Median Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.94|0.96||||||Mean difference between Gauze and Gel ARM B Bladder D2cc||0.96|-0.94|
70930271|NCT04499521|141358742|OTHER||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-0.54|0.16||||||Mean difference between Gauze and Gel ARM A Rectum D2cc||0.16|-0.54|
70930272|NCT04499521|141358742|OTHER||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-0.67|0.29||||||Mean difference between Gauze and Gel ARM B Rectum D2cc||0.29|-0.67|
70930273|NCT03990883|141358745|NON_INFERIORITY|"The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB \> d0 where, pA is the response rate for Princess® FILLER Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested using a 1-sided, McNemar type test at an alpha of 0.025 with a delta of 0.10 (10%).~Assuming pA to be 87% and pB to be 88% a sample size of 222 subjects had been calculated to be sufficient to achieve a power of 90%."|Risk Difference (RD)|0.37|||<|0.0001|TWO_SIDED|95.0|-2.96|3.7|||McNemar|||||3.7|-2.96|<0.0001
70930274|NCT03990883|141358746|NON_INFERIORITY|"The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB \> d0 where, pA is the response rate for Princess® FILLER Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested using a 1-sided, McNemar type test at an alpha of 0.025 with a delta of 0.10 (10%).~Assuming pA to be 87% and pB to be 88% a sample size of 222 subjects had been calculated to be sufficient to achieve a power of 90%."|Risk Difference (RD)|0.0|||<|0.0001|TWO_SIDED|95.0|-3.71|3.71||The threshold for statistical significance is 0.025. A hierarchical approach is used and results are confirmative if all tests previously performed within the hierarchy achieve significance at a one-sided significance level of 0.025.|McNemar|||||3.71|-3.71|<0.0001
71104746|NCT01098747|141716677|SUPERIORITY_OR_OTHER||Difference in proportion|6.05||||0.256|TWO_SIDED|95.0|-4.75|16.84||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||16.84|-4.75|0.256
70850664|NCT04518995|141189569|SUPERIORITY||Risk Difference (RD)|0.39|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.32|0.46||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.46|0.32|<0.0001
70850665|NCT04518995|141189570|SUPERIORITY||Risk Difference (RD)|0.25|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.17|0.32||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.32|0.17|<0.0001
70850666|NCT04518995|141189570|SUPERIORITY||Risk Difference (RD)|0.35|STANDARD_ERROR_OF_MEAN|0.044|<|0.0001|TWO_SIDED|95.0|0.26|0.43||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.43|0.26|<0.0001
70850667|NCT04518995|141189570|SUPERIORITY||Risk Difference (RD)|0.31|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|0.24|0.38||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.38|0.24|<0.0001
70850668|NCT04518995|141189570|SUPERIORITY||Risk Difference (RD)|0.43|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.35|0.51||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.51|0.35|<0.0001
71016003|NCT00561600|141539789|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum cobalt ions were expected to be lower in the ASR-XL group||||0.005
71016004|NCT00561600|141539790|SUPERIORITY_OR_OTHER|||||||0.237|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group||||0.237
71016005|NCT00561600|141539791|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group||||0.001
71016006|NCT00561600|141539792|SUPERIORITY_OR_OTHER|||||||0.121|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group||||0.121
71016007|NCT00561600|141539793|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum Cobalt ions were expected to be lower in the ASR-XL group||||0.012
71016008|NCT00561600|141539794|SUPERIORITY_OR_OTHER|||||||0.103|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group||||0.103
71016009|NCT00561600|141539795|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group||||0.001
71016010|NCT00561600|141539796|SUPERIORITY_OR_OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group||||0.300
71016011|NCT00561600|141539797|SUPERIORITY_OR_OTHER|||||||0.079|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum cobalt ions were expected to be lower in the ASR-XL group||||0.079
71016012|NCT00561600|141539798|SUPERIORITY_OR_OTHER|||||||0.766|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group||||0.766
71016013|NCT00561600|141539799|SUPERIORITY_OR_OTHER|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group||||0.018
71016014|NCT00561600|141539800|SUPERIORITY_OR_OTHER|||||||0.689|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group||||0.689
71016015|NCT00561600|141539801|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum cobalt ions were expected to be lower in the ASR-XL group||||0.048
71016016|NCT00561600|141539802|SUPERIORITY_OR_OTHER|||||||0.782|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group||||0.782
71016017|NCT00561600|141539803|SUPERIORITY_OR_OTHER|||||||0.061|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group||||0.061
71016018|NCT00561600|141539804|SUPERIORITY_OR_OTHER|||||||0.957|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group||||0.957
71016019|NCT01833897|141539839|SUPERIORITY_OR_OTHER||||||<|0.001||||||F1,6.4=161.8,|linear mixed model|||||||<0.001
71016020|NCT01833897|141539840|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71016021|NCT01833897|141539841|SUPERIORITY_OR_OTHER|||||||0.026|||||||ANOVA|||||||0.026
71016022|NCT01833897|141539842|SUPERIORITY_OR_OTHER|||||||0.011|||||||ANOVA|||||||0.011
71016023|NCT01833897|141539843|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71016024|NCT00379821|141539888|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0413|STANDARD_ERROR_OF_MEAN|0.1746||0.8097|TWO_SIDED|95.0|0.7497|1.4463||The a priori threshold for statistical significance is 0.05/3.|Poisson regression|No adjustments|The denominator for the risk ratio is the CQ Monotherapy arm.|Number of clinical malaria episodes per PYAR was compared using Poisson regression assuming null hypothesis that the number of malaria episodes are the same in both groups.||1.4463|0.7497|0.8097
71104747|NCT01098747|141716678|SUPERIORITY_OR_OTHER||Difference in proportion|6.34||||0.078|TWO_SIDED|95.0|1.34|11.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.34|1.34|0.078
71104748|NCT01098747|141716678|SUPERIORITY_OR_OTHER||Difference in proportion|2.74||||0.303|TWO_SIDED|95.0|-3.01|8.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.49|-3.01|0.303
71104749|NCT01098747|141716678|SUPERIORITY_OR_OTHER||Difference in proportion|27.24|||<|0.001|TWO_SIDED|95.0|18.14|36.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||36.34|18.14|<0.001
70930275|NCT03990883|141358747|NON_INFERIORITY|"The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB \> d0 where, pA is the response rate for Princess® FILLER Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested using a 1-sided, McNemar type test at an alpha of 0.025 with a delta of 0.10 (10%).~Assuming pA to be 87% and pB to be 88% a sample size of 222 subjects had been calculated to be sufficient to achieve a power of 90%."|Risk Difference (RD)|-2.96||||0.025|TWO_SIDED|95.0|-9.99|4.07||The threshold for statistical significance is 0.025. A hierarchical approach is used and results are confirmative if all tests previously performed within the hierarchy achieve significance at a one-sided significance level of 0.025.|McNemar|||||4.07|-9.99|0.025
70930276|NCT03990883|141358748|NON_INFERIORITY|"The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB \> d0 where, pA is the response rate for Princess® FILLER Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested using a 1-sided, McNemar type test at an alpha of 0.025 with a delta of 0.10 (10%).~Assuming pA to be 87% and pB to be 88% a sample size of 222 subjects had been calculated to be sufficient to achieve a power of 90%."|Risk Difference (RD)|-0.45||||0.009|TWO_SIDED|95.0|-8.42|7.52||The threshold for statistical significance is 0.025. A hierarchical approach is used and results are confirmative if all tests previously performed within the hierarchy achieve significance at a one-sided significance level of 0.025.|McNemar|||||7.52|-8.42|0.009
70941538|NCT02762500|141383835|SUPERIORITY||Risk Difference (RD)|-8.1||||0.106|TWO_SIDED|90.0|-18.6|2.5||one-sided p-value|Chi-squared|Statistical test was a one-sided performed at the 5% level of significance. Pearson chi-square test was used to test the null hypothesis.|90% CI obtained based on normal approximation.|The response rate difference is the mean difference in response rates between the treatment and placebo responders. The p-value is based on one-sided Pearson chi-square test.||2.5|-18.6|0.106
71016025|NCT00379821|141539888|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1623|STANDARD_ERROR_OF_MEAN|0.1973||0.3767|TWO_SIDED|95.0|0.8333|1.6211||The a priori threshold for statistical significance is 0.05/3.|Poisson regression|No adjustments.|The denominator for the risk ratio is the CQ Monotherapy arm.|Number of clinical malaria episodes per PYAR was compared using Poisson regression assuming null hypothesis that the number of malaria episodes are the same in both groups.||1.6211|0.8333|0.3767
71016026|NCT00379821|141539888|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0707|STANDARD_ERROR_OF_MEAN|0.1795||0.6277|TWO_SIDED|95.0|0.7708|1.4872||The a priori threshold for statistical significance is 0.05/3.|Poisson regression|No adjustments.|The denominator for the risk ratio is the CQ Monotherapy arm.|Number of clinical malaria episodes per PYAR was compared using Poisson regression assuming null hypothesis that the number of malaria episodes are the same in both groups.||1.4872|0.7708|0.6277
71016027|NCT00379821|141539922|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96|STANDARD_ERROR_OF_MEAN|0.17||0.79|TWO_SIDED|95.0|0.68|1.34||Not adjusted, 0.05|Regression, Cox|There are no adjustments.|The reference category is those who did not travel.|||1.34|0.68|0.79
71016028|NCT00975000|141539961|SUPERIORITY_OR_OTHER||Chi-Square test statistic|66.437|||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by baseline corrected total serum calcium level (≤ 11.2 mg/dL and \> 11.2 mg/dL)||The primary endpoint was tested at a significance level of 0.05.||||<0.001
71016029|NCT00975000|141539961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|91.41|||||TWO_SIDED|95.0|18.76|445.41|||||Odds ratio of Cinacalcet/Placebo|||445.41|18.76|
71016030|NCT00975000|141539961|SUPERIORITY_OR_OTHER||Difference|75.44|||||TWO_SIDED|95.0|63.83|87.05|||||Difference = Cinacalcet-Placebo|||87.05|63.83|
71016031|NCT00975000|141539962|SUPERIORITY_OR_OTHER||Difference|1.41||||0.266|TWO_SIDED|95.0|-1.1|3.93|||ANCOVA|Analysis of covariance (ANCOVA) with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the percent change in BMD between the 2 treatment groups (cinacalcet - placebo)|||3.93|-1.10|0.266
71016032|NCT00975000|141539963|SUPERIORITY_OR_OTHER||Difference|0.45|||<|0.001|TWO_SIDED|95.0|0.26|0.64|||ANCOVA|Analysis of covariance (ANCOVA) with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the absolute change in mean serum phosphorus between the 2 treatment groups (cinacalcet - placebo)|||0.64|0.26|<0.001
71104750|NCT01098747|141716678|SUPERIORITY_OR_OTHER||Difference in proportion|6.66||||0.217|TWO_SIDED|95.0|-4.31|17.63||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.63|-4.31|0.217
71016033|NCT00975000|141539964|SUPERIORITY_OR_OTHER||Difference|-0.4||||0.842|TWO_SIDED|95.0|-4.37|3.57|||ANCOVA|ANCOVA with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the absolute change in mean eGFR between the 2 treatment groups (cinacalcet - placebo)|||3.57|-4.37|0.842
71016034|NCT00975000|141539965|SUPERIORITY_OR_OTHER||Difference|-1.39|||<|0.001|TWO_SIDED|95.0|-1.62|-1.16|||ANCOVA|ANCOVA with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the absolute change in corrected total calcium between the 2 treatment groups (cinacalcet - placebo)|||-1.16|-1.62|<0.001
71016035|NCT00975000|141539966|SUPERIORITY_OR_OTHER||Difference|-117.21||||0.002|TWO_SIDED|95.0|-189.88|-44.55|||ANCOVA|ANCOVA with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the absolute change in iPTH between the 2 treatment groups (cinacalcet - placebo)|||-44.55|-189.88|0.002
71016036|NCT00975000|141539967|SUPERIORITY_OR_OTHER||Difference|-1.42||||0.846|TWO_SIDED|95.0|-15.91|13.06|||ANCOVA|ANCOVA with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the absolute change in urine phosphorus between the 2 treatment groups (cinacalcet - placebo)|||13.06|-15.91|0.846
71016037|NCT01441401|141539985|SUPERIORITY_OR_OTHER_LEGACY|||||||0.045|||||||Fisher Exact|||"The factor tested was baseline severity of epileptic seizure. The null hypothesis was that there was no association between the baseline severity of epileptic seizure (mild, moderate, and severe) and the number of participants who responded to the treatment with gabapentin."||||0.045
71016038|NCT01441401|141539985|SUPERIORITY_OR_OTHER_LEGACY|||||||0.017|||||||Cochran-Armitage (EXACT)|||"The factor tested was baseline severity of epileptic seizure. The null hypothesis was that there was no ordinal trend in the number of responders to the treatment with gabapentin across the baseline severity of epileptic seizure (mild, moderate, and severe)."||||0.017
71016039|NCT01441401|141539986|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||Fisher Exact|||"The factor tested was baseline frequency of epileptic seizure. The null hypothesis was that there was no difference between the baseline frequency of epileptic seizure and the number of participants who responded to the treatment with gabapentin."||||0.018
71016040|NCT01441401|141539987|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034|||||||Fisher Exact|||"The factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no association between the number of concomitant antiepileptic drugs at baseline and the number of participants who responded to the treatment with gabapentin."||||0.034
71016041|NCT01441401|141539987|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Cochran-Armitage (EXACT)|||"The factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no ordinal trend in the number of responders to the treatment with gabapentin across the increasing number of concomitant antiepileptic drugs at baseline."||||0.005
71016042|NCT01441401|141539988|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||"The factor tested was treatment period with gabapentin. The null hypothesis was that there was no association between the treatment period with gabapentin and the number of participants who responded to the treatment with gabapentin."||||<0.001
71016043|NCT01607398|141540019|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-8.05||||0.5146|TWO_SIDED|95.0|-20.5|7.6|||Wilcoxon (Mann-Whitney)|The analysis was done using the Van Elteren extension to the Wilcoxon rank sum test.|From Van-Elteren extension to the Wilcoxon Rank Sum test, adjusted for smoking status strata and Hodges-Lehmann estimator of the 95% CI, not stratified and unadjusted for multiplicity.|||7.600|-20.500|0.5146
71016044|NCT00929201|141540063|NON_INFERIORITY_OR_EQUIVALENCE|The FMI sitagliptin/metformin 50/500 mg FDC tablet and coadministration of corresponding doses of sitagliptin and metformin as individual tablets after consumption of a standard high-fat breakfast will be bioequivalent for metformin based on assessment of the AUC0-∞ for metformin \[i.e., the true metformin AUC0-∞GMR (sitagliptin/metformin 50/500 mg FDC tablet/co-administration of sitagliptin and metformin as individual tablets will be contained within (0.80, 1.25)\].|Least-Squares Mean Ratio|0.97||||||90.0|0.95|1.0||||||Least-Squares Mean Ratio calculated as Sitagliptin/Metformin 50/500 mg FDC tablet divided by Sitagliptin 50 mg and metformin 500 mg individual tablets||1.00|0.95|
71016045|NCT00929201|141540064|NON_INFERIORITY_OR_EQUIVALENCE|The FMI sitagliptin/metformin 50/500 mg FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets after consumption of a standard high-fat breakfast will be bioequivalent for metformin based on assessment of the Cmax for metformin \[i.e., the true metformin Cmax GMR (sitagliptin/metformin 50/500 mg FDC tablet/ co-administration of sitagliptin and metformin as individual tablets will be contained within (0.80, 1.25)\].|Least-Squares Mean Ratio|0.95||||||90.0|0.93|0.98||||||Least-Squares Mean Ratio calculated as Sitagliptin/Metformin 50/500 mg FDC tablet divided by Sitagliptin 50 mg and metformin 500 mg individual tablets||0.98|0.93|
71016046|NCT01299272|141540072|SUPERIORITY_OR_OTHER|||||||0.485|||||||Log Rank|||||||0.485
71016047|NCT00464308|141540101|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 450 subjects per arm will give a 90% power (with a one-sided 95% confidence interval and a minimal clinically important difference of 9%) to demonstrate non-inferiority of rabeprazole 20mg to esomeprazole 40mg with respect to the number of patients with complete resolution of heartburn with or without regurgitation at week 4|Proportion difference|-0.11|||<|0.05||95.0||||Adjustment for multiple comparisons was not made. The a priori threshold for statistical significance was p\<0.05. Tests were 2-sided except for the non-inferiority test which was 1-sided.|Non-inferiority||Assumed that the true resolution rates in the rab20 and eso40 groups would be 30% (0.3). Non inferiority was considered proven if the lower confidence interval of the one sided 95% CI of P(rab20)-P(e40) was above -9%|Primary endpoints were assessed using non-inferiority tests. See below.||||<0.05
71104751|NCT01098747|141716678|SUPERIORITY_OR_OTHER||Difference in proportion|41.16|||<|0.001|TWO_SIDED|95.0|31.2|51.12||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||51.12|31.20|<0.001
70850669|NCT04518995|141189570|SUPERIORITY||Risk Difference (RD)|0.32|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.26|0.39||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.39|0.26|<0.0001
70930277|NCT03990883|141358749|NON_INFERIORITY|"The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB \> d0 where, pA is the response rate for Princess® FILLER Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested using a 1-sided, McNemar type test at an alpha of 0.025 with a delta of 0.10 (10%).~Assuming pA to be 87% and pB to be 88% a sample size of 222 subjects had been calculated to be sufficient to achieve a power of 90%."|Risk Difference (RD)|-0.37|||<|0.0001|TWO_SIDED|95.0|-3.85|3.11||The threshold for statistical significance is 0.025. A hierarchical approach is used and results are confirmative if all tests previously performed within the hierarchy achieve significance at a one-sided significance level of 0.025.|McNemar|||||3.11|-3.85|<0.0001
70930278|NCT03990883|141358750|NON_INFERIORITY|"The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB \> d0 where, pA is the response rate for Princess® FILLER Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested using a 1-sided, McNemar type test at an alpha of 0.025 with a delta of 0.10 (10%).~Assuming pA to be 87% and pB to be 88% a sample size of 222 subjects had been calculated to be sufficient to achieve a power of 90%."|Risk Difference (RD)|-0.45|||<|0.0001|TWO_SIDED|95.0|-4.05|3.16||The threshold for statistical significance is 0.025. A hierarchical approach is used and results are confirmative if all tests previously performed within the hierarchy achieve significance at a one-sided significance level of 0.025.|McNemar|||||3.16|-4.05|<0.0001
70930279|NCT05247034|141358772|OTHER||||||>|0.05|||||||t-test, 2 sided|||"Comparing row Change from baseline at Week 12"||||>0.05
70930280|NCT05247034|141358772|OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||||||0.0001
70930281|NCT05247034|141358772|OTHER|||||||0.0125|||||||Wilcoxon (Mann-Whitney)|||||||0.0125
70930282|NCT05247034|141358773|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||For 1 Hz||||>0.05
70930283|NCT05247034|141358773|OTHER||||||>|0.05|||||||t-test, 2 sided|||5 and 10 Hz||||>0.05
70930284|NCT05247034|141358773|OTHER||||||>|0.05|||||||t-test, 2 sided|||For 1, 5 and 10 Hz||||>0.05
70930285|NCT05247034|141358773|OTHER||||||>|0.05|||||||t-test, 2 sided|||For 1, 5 and 10 Hz||||>0.05
71049965|NCT02504671|141606196|OTHER||Mean Difference (Net)|-7.94||||0.068|TWO_SIDED|95.0|-16.47|0.58||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Pain score|||0.58|-16.47|0.068
70850670|NCT04518995|141189570|SUPERIORITY||Risk Difference (RD)|0.47|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|0.39|0.55||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.55|0.39|<0.0001
70930286|NCT05247034|141358774|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
70930287|NCT05247034|141358774|OTHER|||||||0.042|||||||Friedman|||||||0.042
70930288|NCT05247034|141358774|OTHER|||||||0.015|||||||Friedman|||||||0.015
70930289|NCT05247034|141358775|OTHER||||||>|0.05|||||||Z Test|||||||>0.05
70930290|NCT05247034|141358775|OTHER||||||>|0.05|||||||Z Test|||||||>0.05
70930291|NCT05247034|141358775|OTHER||||||>|0.05|||||||Z Test|||||||>0.05
70930292|NCT05247034|141358776|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
70930293|NCT05247034|141358776|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
70930294|NCT05247034|141358776|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
70930295|NCT05247034|141358777|OTHER||||||>|0.05|||||||t-test, 2 sided|||"Comparing row Change from baseline at Week 12"||||>0.05
70930296|NCT05247034|141358777|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
70930297|NCT05247034|141358777|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
70930298|NCT05247034|141358778|OTHER||||||>|0.05|||||||t-test, 2 sided|||"Comparing row Change from baseline at Week 12"||||>0.05
70930299|NCT05247034|141358778|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
70930300|NCT05247034|141358778|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
70930301|NCT05247034|141358779|OTHER||||||>|0.05|||||||t-test, 2 sided|||"Comparing row Change from baseline at Week 12"||||>0.05
70930302|NCT05247034|141358779|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
70930303|NCT05247034|141358779|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
70930304|NCT05247034|141358780|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
70930305|NCT05247034|141358780|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
70930306|NCT05247034|141358780|OTHER||||||>|0.05|||||||Friedman|||||||>0.05
70930307|NCT05247034|141358781|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
70930308|NCT05247034|141358781|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
70930309|NCT05247034|141358781|OTHER||||||>|0.05|||||||Friedman|||||||>0.05
70930310|NCT05247034|141358782|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
70930311|NCT05247034|141358782|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
70930312|NCT05247034|141358782|OTHER|||||||0.0027|||||||Wilcoxon (Mann-Whitney)|||||||0.0027
70930313|NCT05247034|141358783|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
70930314|NCT05247034|141358783|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
70930315|NCT05247034|141358783|OTHER|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||||||0.0430
70930316|NCT05247034|141358784|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
70930317|NCT05247034|141358784|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
70930318|NCT05247034|141358784|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
70930319|NCT05247034|141358785|OTHER||||||>|0.05|||||||t-test, 2 sided|||"Comparing row Change from baseline at Week 12"||||>0.05
70930320|NCT05247034|141358785|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
70930321|NCT05247034|141358785|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
70930322|NCT05247034|141358786|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
71016048|NCT00464308|141540104|NON_INFERIORITY_OR_EQUIVALENCE|The sample size calculation was based upon the number of patients acheiveing complete resolution of HEARTBURN. A sample size of 450 subjects per arm will give a 90% power (with a one-sided 95% confidence interval and a minimal clinically important difference of 9%) to demonstrate non-inferiority of rabeprazole 20mg to esomeprazole 40mg with respect to the number of patients with complete resolution of heartburn with or without regurgitation at week 4|Proportion difference|-0.051|||<|0.05||95.0||||All statistical tests were interpreted at the 5% significance level (2-tailed).|non-inferiority||Non inferiority was considered proven if the lower confidence interval of the one sided 95% CI of P(rab20)-P(e40) was above -9%|Primary endpoints were assessed using non-inferiority tests. See below.||||<0.05
71016049|NCT00464308|141540105|NON_INFERIORITY_OR_EQUIVALENCE|The sample size calculation was based upon the number of patients acheiveing complete resolution of HEARTBURN. A sample size of 450 subjects per arm will give a 90% power (with a one-sided 95% confidence interval and a minimal clinically important difference of 9%) to demonstrate non-inferiority of rabeprazole 20mg to esomeprazole 40mg with respect to the number of patients with complete resolution of heartburn with or without regurgitation at week 4|Proportion difference|-0.053|||<|0.05||95.0||||Adjustment for multiple comparisons was not made. The a priori threshold for statistical significance was p\<0.05. Tests were 2-sided except for the non-inferiority test which was 1-sided.|non-inferiority||Non inferiority was considered proven if the lower confidence interval of the one sided 95% CI of P(rab20)-P(e40) was above -9%|Primary endpoints were assessed using non-inferiority tests. See below.||||<0.05
71016050|NCT00464308|141540106|NON_INFERIORITY_OR_EQUIVALENCE|The sample size calculation was based upon the number of patients acheiveing complete resolution of HEARTBURN. A sample size of 450 subjects per arm will give a 90% power (with a one-sided 95% confidence interval and a minimal clinically important difference of 9%) to demonstrate non-inferiority of rabeprazole 20mg to esomeprazole 40mg with respect to the number of patients with complete resolution of heartburn with or without regurgitation at week 4|Proportion difference|-0.061|||<|0.05||95.0||||Adjustment for multiple comparisons was not made. The a priori threshold for statistical significance was p\<0.05. Tests were 2-sided except for the non-inferiority test which was 1-sided.|non-inferiority||Non inferiority was considered proven if the lower confidence interval of the one sided 95% CI of P(rab20)-P(e40) was above -9%|Primary endpoints were assessed using non-inferiority tests. See below.||||<0.05
71016051|NCT03533608|141540119|OTHER|Descriptive|Mean Difference (Final Values)|19.51|||||TWO_SIDED|||||||||||||
71016052|NCT03533608|141540120|OTHER|Descriptive|Mean Difference (Final Values)|4.04|||||TWO_SIDED|||||||||||||
71016053|NCT01900392|141540149|OTHER||||||>|0.1|||||||Regression, Linear|||||||>0.1
71016054|NCT00826176|141540164|SUPERIORITY_OR_OTHER||upper limit of tolerance interval (min.)|6.4||||||95.0|||||||The tolerance interval (TI) refers to a fixed proportion (in this trial set to 95%) of the population with a stated confidence (in this trial, 95%). Efficacy was to be claimed in case the upper limit of TI was below the prespecified margin of 10 min.|||||
71016055|NCT00826176|141540164|SUPERIORITY_OR_OTHER||upper limit of tolerance interval (min.)|3.2||||||95.0|||||||The tolerance interval (TI) refers to a fixed proportion (in this trial set to 95%) of the population with a stated confidence (in this trial, 95%). Efficacy was to be claimed in case the upper limit of TI was below the prespecified margin of 10 min.|||||
71016056|NCT00826176|141540164|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence between the two subject populations was to be claimed in the event that the two-sided 95% confidence interval was entirely within the interval ranging from -60 to +60 seconds.|median difference (seconds)|49.0||||||95.0|30.0|72.0|||||The estimated median difference (Chinese minus Caucasian) in time to recovery of the T4/T1 ratio to 0.9.|||72|30|
71104752|NCT01098747|141716678|SUPERIORITY_OR_OTHER||Difference in proportion|8.86||||0.149|TWO_SIDED|95.0|-3.33|21.04||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||21.04|-3.33|0.149
71104753|NCT01098747|141716678|SUPERIORITY_OR_OTHER||Difference in proportion|48.61|||<|0.001|TWO_SIDED|95.0|38.49|58.73||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||58.73|38.49|<0.001
71104754|NCT01098747|141716678|SUPERIORITY_OR_OTHER||Difference in proportion|4.55||||0.477|TWO_SIDED|95.0|-8.03|17.13||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.13|-8.03|0.477
71104755|NCT01098747|141716678|SUPERIORITY_OR_OTHER||Difference in proportion|52.81|||<|0.001|TWO_SIDED|95.0|42.63|62.99||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||62.99|42.63|<0.001
71016057|NCT01687400|141540167|OTHER|||||||0.035|||||||Fisher Exact|||Statistical analysis #1 is for the genetic mutation TP53.||||0.035
71016058|NCT01687400|141540167|OTHER|||||||0.72|||||||Fisher Exact|||Statistical analysis #2 is for ASXL1 genetic mutation||||0.72
71104756|NCT01098747|141716678|SUPERIORITY_OR_OTHER||Difference in proportion|-2.14||||0.739|TWO_SIDED|95.0|-14.77|10.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.50|-14.77|0.739
71016059|NCT01687400|141540167|OTHER|||||||0.28|||||||Fisher Exact|||Statistical analysis #3 is for SRSF2 genetic mutation||||0.28
71016060|NCT01687400|141540167|OTHER|||||||0.14|||||||Fisher Exact|||Statistical analysis #4 is for IDH2 genetic mutation||||0.14
71049966|NCT02504671|141606196|OTHER||Mean Difference (Net)|-13.96||||0.001|TWO_SIDED|95.0|-22.47|-5.44||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Pain score|||-5.44|-22.47|0.001
70850671|NCT04518995|141189570|SUPERIORITY||Risk Difference (RD)|0.38|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.31|0.44||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.44|0.31|<0.0001
70850672|NCT04518995|141189570|SUPERIORITY||Risk Difference (RD)|0.47|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|0.39|0.55||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.55|0.39|<0.0001
70850673|NCT04518995|141189571|SUPERIORITY||Risk Difference (RD)|0.01|STANDARD_ERROR_OF_MEAN|0.005||0.0816|TWO_SIDED|95.0|0.0|0.02||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 4||0.02|-0.00|0.0816
70850674|NCT04518995|141189571|SUPERIORITY||Risk Difference (RD)|0.03|STANDARD_ERROR_OF_MEAN|0.01||0.0005|TWO_SIDED|95.0|0.01|0.05||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 8||0.05|0.01|0.0005
70850675|NCT04518995|141189571|SUPERIORITY||Risk Difference (RD)|0.06|STANDARD_ERROR_OF_MEAN|0.016||0.0002|TWO_SIDED|95.0|0.03|0.09||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 8||0.09|0.03|0.0002
70850676|NCT04518995|141189571|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.06|0.14||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.14|0.06|<0.0001
70850677|NCT04518995|141189571|SUPERIORITY||Risk Difference (RD)|0.17|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.12|0.22||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.22|0.12|<0.0001
70850678|NCT04518995|141189571|SUPERIORITY||Risk Difference (RD)|0.14|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.1|0.19||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.19|0.10|<0.0001
70850679|NCT04518995|141189571|SUPERIORITY||Risk Difference (RD)|0.27|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.2|0.33||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.33|0.20|<0.0001
70850680|NCT04518995|141189571|SUPERIORITY||Risk Difference (RD)|0.23|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.19|0.28||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.28|0.19|<0.0001
70850681|NCT04518995|141189571|SUPERIORITY||Risk Difference (RD)|0.35|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.28|0.41||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.41|0.28|<0.0001
71016061|NCT01687400|141540167|OTHER|||||||0.3|||||||Fisher Exact|||Statistical analysis #5 is for DNMT3A genetic mutation||||0.3
71049967|NCT02504671|141606196|OTHER||Mean Difference (Net)|-7.36||||0.118|TWO_SIDED|95.0|-16.62|1.89||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, Pain score|||1.89|-16.62|0.118
71049968|NCT02504671|141606196|OTHER||Mean Difference (Net)|-12.43||||0.009|TWO_SIDED|95.0|-21.68|-3.19||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, Pain score|||-3.19|-21.68|0.009
71049969|NCT02504671|141606196|OTHER||Mean Difference (Net)|-16.51||||0.001|TWO_SIDED|95.0|-26.38|-6.65||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, Pain score|||-6.65|-26.38|0.001
71049970|NCT02504671|141606196|OTHER||Mean Difference (Net)|-20.39|||<|0.001|TWO_SIDED|95.0|-30.27|-10.52||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, Pain score|||-10.52|-30.27|<0.001
71049971|NCT02504671|141606196|OTHER||Mean Difference (Net)|-12.0||||0.022|TWO_SIDED|95.0|-22.27|-1.73||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Pain score|||-1.73|-22.27|0.022
71016062|NCT01687400|141540167|OTHER|||||||0.183|||||||Fisher Exact|||Statistical analysis #6 is for SF3B1 genetic mutation||||0.183
71016063|NCT01687400|141540167|OTHER|||||||0.42|||||||Fisher Exact|||Statistical analysis #7 is for RUNX1 genetic mutation||||0.42
71016064|NCT01687400|141540167|OTHER|||||||0.36|||||||Fisher Exact|||Statistical analysis #8 is for TET2 genetic mutation||||0.36
71049972|NCT02504671|141606196|OTHER||Mean Difference (Net)|-17.94|||<|0.001|TWO_SIDED|95.0|-28.18|-7.7||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Pain score|||-7.70|-28.18|<0.001
71049973|NCT02504671|141606196|OTHER||Mean Difference (Net)|-13.2||||0.084|TWO_SIDED|95.0|-28.18|1.79||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, Pain score|||1.79|-28.18|0.084
71049974|NCT02504671|141606196|OTHER||Mean Difference (Net)|-11.87||||0.099|TWO_SIDED|95.0|-26.02|2.27||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, Pain score|||2.27|-26.02|0.099
71104757|NCT01098747|141716678|SUPERIORITY_OR_OTHER||Difference in proportion|48.53|||<|0.001|TWO_SIDED|95.0|36.29|60.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||60.77|36.29|<0.001
71104758|NCT01098747|141716678|SUPERIORITY_OR_OTHER||Difference in proportion|-6.8||||0.28|TWO_SIDED|95.0|-19.24|5.65||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||5.65|-19.24|0.280
71104759|NCT01098747|141716678|SUPERIORITY_OR_OTHER||Difference in proportion|48.53|||<|0.001|TWO_SIDED|95.0|36.29|60.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||60.77|36.29|<0.001
71104760|NCT01098747|141716678|SUPERIORITY_OR_OTHER||Difference in proportion|-8.01||||0.202|TWO_SIDED|95.0|-20.44|4.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.41|-20.44|0.202
71104761|NCT01098747|141716678|SUPERIORITY_OR_OTHER||Difference in proportion|48.53|||<|0.001|TWO_SIDED|95.0|36.29|60.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||60.77|36.29|<0.001
71104762|NCT01098747|141716678|SUPERIORITY_OR_OTHER||Difference in proportion|-8.61||||0.17|TWO_SIDED|95.0|-21.02|3.8||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.80|-21.02|0.170
71104763|NCT01098747|141716678|SUPERIORITY_OR_OTHER||Difference in proportion|48.53|||<|0.001|TWO_SIDED|95.0|36.29|60.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||60.77|36.29|<0.001
71016065|NCT01687400|141540167|OTHER|||||||0.1|||||||Fisher Exact|||Statistical analysis #9 is for IDH1 genetic mutation||||0.1
70850682|NCT04518995|141189572|SUPERIORITY||Least Square (LS) Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|1.13||0.0564|TWO_SIDED|95.0|-4.4|0.1||P-value was calculated by mixed model repeated measures (MMRM) analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 4||0.1|-4.4|0.0564
70930323|NCT05247034|141358786|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71016066|NCT01687400|141540167|OTHER|||||||1|||||||Fisher Exact|||Statistical analysis #10 is for NPM1 genetic mutation||||1
71016067|NCT01687400|141540167|OTHER|||||||0.17|||||||Fisher Exact|||Statistical analysis #11 is for NRAS genetic mutation||||0.17
71016068|NCT01687400|141540167|OTHER|||||||1|||||||Fisher Exact|||-Statistical analysis #12 is for U2AF1 genetic mutation||||1
71016069|NCT01687400|141540167|OTHER|||||||0.6|||||||Fisher Exact|||Statistical analysis #13 is for MY05B genetic mutation||||0.6
71016070|NCT01687400|141540167|OTHER|||||||1|||||||Fisher Exact|||Statistical analysis #14 is for WT1 genetic mutation||||1
71016071|NCT01687400|141540168|SUPERIORITY||Overall Response Rate-for current study|0.744|||<|0.0001|TWO_SIDED|95.0|0.652|0.836|||Chi-squared|1-sample Chi-square test to compare the overall response rate (ORR) to historical control (with ORR=0.25)||-The historical control of a 5-day regimen (Cashen et al 2010 JCO = NCT00358644) showed 25% (14 out of 55 participants) in overall response rate||0.836|0.652|<0.0001
71016072|NCT01687400|141540168|SUPERIORITY||Complete response rate-for current study|0.64|||<|0.0001|TWO_SIDED|95.0|0.538|0.741|||Chi-squared|1-sample Chi-square test to compare the complete response rate to historical control (with CR=0.24)||-The historical control of a 5-day regimen (Cashen et al 2010 JCO = NCT00358644) showed 24% (13 out of 55 participants) in complete response rate.||0.741|0.538|<0.0001
71016073|NCT03731325|141540172|SUPERIORITY||Mean Difference (Net)|2.2|||<|0.01|TWO_SIDED||||||ANOVA||This mean difference represents the main effect of time from baseline to 15 weeks, regardless of group|Change in parent BMI from baseline at 8,11 to 15 weeks||||<0.01
71016074|NCT03731325|141540173|SUPERIORITY||Mean Difference (Net)|-10.5||||0.003|TWO_SIDED|||||main effect of time|ANOVA||This is the main effect of weight change at week 15, e.g. average weight change from baseline to week 15 in the entire sample of parents|repeated measures analysis of variance for time (0,8,11,15 weeks) for weight change (lbs)||||0.003
71016075|NCT03731325|141540174|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.06|TWO_SIDED||||||ANOVA||average difference in BMI percentile for entire sample|Repeated measures ANOVA for child BMI percentile at 0, 8, 11 and 15 weeks||||0.06
71016076|NCT03731325|141540175|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.07|TWO_SIDED||||||ANOVA||average change in delay discounting measure area under the curve for all participants (parents and children) in both groups from baseline to week 15|repeated measures ANOVA, reporting repeated measures effect only||||0.07
71016077|NCT03731325|141540176|SUPERIORITY||Mean Difference (Net)|-0.8||||0.64|TWO_SIDED||||||ANOVA||Difference between weight at baseline and week 15 in lbs for all children, regardless of group|||||0.64
71016078|NCT00297882|141540182|NON_INFERIORITY|Non-inferiority of AQ-AS compared to AL was assessed by constructing a one-sided, lower limit asymptotic 97.5% CI on the difference of polymerase chain reaction (PCR)-corrected cure rates of AQ-AS when compared to AL. Non-inferiority was declared if the lower limit of the CI was greater than -10% for AQ-AS.|||||>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Sample Size will be determined by N = {\[(Zα/2)/E\]\*2}pq where Where: n=sample size; Zα/2= Z value of a two-tailed test with 95% confidence level=1.96; p represents cure rate, q=1-p, which represents treatment failure rate of; E=precision of 5%||||>0.05
71016079|NCT00297882|141540183|NON_INFERIORITY|Non-inferiority of AQ-AS compared to AL was assessed by constructing a one-sided, lower limit asymptotic 97.5% CI on the difference of polymerase chain reaction (PCR)-corrected cure rates of AQ-AS when compared to AL. Non-inferiority was declared if the lower limit of the CI was greater than -10% for AQ-AS.|||||>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Sample Size will be determined by N = {\[(Zα/2)/E\]\*2}pq where Where: n=sample size; Zα/2= Z value of a two-tailed test with 95% confidence level=1.96; p represents cure rate, q=1-p, which represents treatment failure rate of; E=precision of 5%||||>0.05
71104764|NCT01098747|141716678|SUPERIORITY_OR_OTHER||Difference in proportion|-9.23||||0.14|TWO_SIDED|95.0|-21.62|3.16||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.16|-21.62|0.140
71104765|NCT01098747|141716678|SUPERIORITY_OR_OTHER||Difference in proportion|48.53|||<|0.001|TWO_SIDED|95.0|36.29|60.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||60.77|36.29|<0.001
70850683|NCT04518995|141189572|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.23||0.0054|TWO_SIDED|95.0|-5.9|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 4||-1.0|-5.9|0.0054
70850684|NCT04518995|141189572|SUPERIORITY||LS Mean Difference|-8.5|STANDARD_ERROR_OF_MEAN|2.16|<|0.0001|TWO_SIDED|95.0|-12.7|-4.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 8||-4.3|-12.7|<0.0001
71104766|NCT01098747|141716678|SUPERIORITY_OR_OTHER||Difference in proportion|-9.23||||0.14|TWO_SIDED|95.0|-21.62|3.16||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.16|-21.62|0.140
71104767|NCT01098747|141716679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|||<|0.001|TWO_SIDED|95.0|0.83|0.98||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Ibuprofen sodium - placebo) and the associated CI were calculated based on the weighted Gamma statistic.||0.98|0.83|<0.001
70930324|NCT05247034|141358786|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71016080|NCT04242264|141540185|SUPERIORITY|A two-sided Chi-squared test with alpha=0.05 was used to test the null hypothesis that the vaccine efficacy is zero, which is equivalent to testing that the relative risk of shigellosis is one.|Vaccine efficacy|0.89|||<|0.001|TWO_SIDED|95.0|0.71|0.96|||Chi-squared||Vaccine efficacy was calculated as 1 - relative risk of shigellosis, where relative risk = probability of shigellosis in WRSs2 group / probability of shigellosis in placebo group. A Wilson (Score) CI was calculated for the vaccine efficacy estimate.|The null hypothesis is that the absolute vaccine efficacy (VE) of preventing shigellosis is zero. The alternative hypothesis is that the absolute VE is greater than zero.||0.96|0.71|<0.001
71016081|NCT04242264|141540186|OTHER|Vaccine efficacy was calculated as 1 - relative risk of shigellosis, where relative risk = probability of shigellosis in WRSs2 group / probability of shigellosis in placebo group. A Wilson (Score) CI was calculated for the vaccine efficacy estimate, but no formal hypothesis test was performed.|Vaccine efficacy|0.77|||||TWO_SIDED|95.0|0.44|0.92||||||||0.92|0.44|
71016082|NCT04242264|141540186|OTHER|Vaccine efficacy was calculated as 1 - relative risk of shigellosis, where relative risk = probability of shigellosis in WRSs2 group / probability of shigellosis in placebo group. A Wilson (Score) CI was calculated for the vaccine efficacy estimate, but no formal hypothesis test was performed.|Vaccine efficacy|1.0|||||TWO_SIDED|95.0|0.78|1.0||||||||1.00|0.78|
71016083|NCT04242264|141540186|OTHER|Vaccine efficacy was calculated as 1 - relative risk of shigellosis, where relative risk = probability of shigellosis in WRSs2 group / probability of shigellosis in placebo group. A Wilson (Score) CI was calculated for the vaccine efficacy estimate, but no formal hypothesis test was performed.|Vaccine efficacy|1.0|||||TWO_SIDED|95.0|0.71|1.0||||||||1.00|0.71|
71049975|NCT02504671|141606196|OTHER||Mean Difference (Net)|-13.91||||0.048|TWO_SIDED|95.0|-27.68|-0.14||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, Pain score|||-0.14|-27.68|0.048
71049976|NCT02504671|141606196|OTHER||Mean Difference (Net)|-13.22||||0.048|TWO_SIDED|95.0|-26.32|-0.13||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, Pain score|||-0.13|-26.32|0.048
71049977|NCT02504671|141606196|OTHER||Mean Difference (Net)|-13.23||||0.102|TWO_SIDED|95.0|-29.11|2.64||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Pain score|||2.64|-29.11|0.102
71049978|NCT02504671|141606196|OTHER||Mean Difference (Net)|-16.7||||0.03|TWO_SIDED|95.0|-31.79|-1.62||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Pain score|||-1.62|-31.79|0.030
71049979|NCT02504671|141606197|OTHER||Mean Difference (Net)|0.6||||0.683|TWO_SIDED|95.0|-2.31|3.52||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, PCS|||3.52|-2.31|0.683
71016084|NCT04139642|141540210|SUPERIORITY||||||<|0.0001||||||A mixed-effects model with provider as a random effect and month as a fixed effect was used to test the main effect of arm.|Mixed Models Analysis|||The null hypothesis was that the rate of balance-related diagnosis as a percentage of total visits would be the same between the historical control period, the active control (weight-only), and the intervention (balance+weight), considering provider and month as co-variates.||||<0.0001
71016085|NCT04139642|141540211|SUPERIORITY||||||=|0.15||||||Mixed-effects model with provider as a random effect and month as a fixed effect. Statistical significance a priori threshold set at 0.05.|Mixed Models Analysis|||The null hypothesis was that the rate of balance-related referral as a percentage of total visits would be the same between the historical control period, the active control (weight-only), and the intervention (balance+weight), considering provider and month as co-variates.||||=0.15
71016086|NCT00539006|141540248|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|0.22|<|0.001||95.0|-1.5|-0.6|||ANCOVA||Mean Difference = Mean Change in FFNS - Mean Change in Placebo|FFNS combined across treatment arms 1 \& 2 compared with Placebo FFNS combined across treatment arms 1 \& 2.||-0.6|-1.5|<0.001
71049980|NCT02504671|141606197|OTHER||Mean Difference (Net)|3.19||||0.03|TWO_SIDED|95.0|0.31|6.07||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, PCS|||6.07|0.31|0.030
71049981|NCT02504671|141606197|OTHER||Mean Difference (Net)|2.61||||0.074|TWO_SIDED|95.0|-0.25|5.47||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, PCS|||5.47|-0.25|0.074
71049982|NCT02504671|141606197|OTHER||Mean Difference (Net)|1.46||||0.39|TWO_SIDED|95.0|-1.88|4.8||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, PCS|||4.80|-1.88|0.390
71049983|NCT02504671|141606197|OTHER||Mean Difference (Net)|2.42||||0.154|TWO_SIDED|95.0|-0.91|5.75||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, PCS|||5.75|-0.91|0.154
71049984|NCT02504671|141606197|OTHER||Mean Difference (Net)|1.73||||0.302|TWO_SIDED|95.0|-1.56|5.02||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, PCS|||5.02|-1.56|0.302
71049985|NCT02504671|141606197|OTHER||Mean Difference (Net)|1.69||||0.521|TWO_SIDED|95.0|-3.5|6.88||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, PCS|||6.88|-3.50|0.521
70930325|NCT05247034|141358787|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
70930326|NCT05247034|141358787|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71016087|NCT00539006|141540248|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.22||0.004||95.0|-1.1|-0.2|||ANCOVA||Mean Difference = Mean Change in FPNS - Mean Change in Placebo|FPNS combined across treatment arms 1 \& 2 compared with Placebo FPNS combined across treatment arms 1 \& 2.||-0.2|-1.1|0.004
71016088|NCT00539006|141540249|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH): stratified approximation to Prescotts test; variation of chi-square test for treatment sequence/subjects no preference.||Statistical analysis applies to FFNS and FPNS categories.||||<0.001
71016089|NCT00258310|141540254|SUPERIORITY_OR_OTHER_LEGACY||proportion|0.74|||||TWO_SIDED|95.0|0.59|0.9||||||||.90|.59|
71016090|NCT00256217|141540258|OTHER||Mean Difference (Final Values)|4.9||||0.004|TWO_SIDED|95.0|1.8|8.0|||Wilcoxon (Mann-Whitney)|||||8.0|1.8|0.004
71016091|NCT00256217|141540259|OTHER||Mean Difference (Final Values)|0.3||||0.016|TWO_SIDED|95.0|0.1|0.49|||Wilcoxon (Mann-Whitney)|||||0.49|0.10|0.016
71016092|NCT01139801|141540274|SUPERIORITY||Mean Difference (Final Values)|212.2||||0.037|TWO_SIDED|95.0|13.3|411.0|||t-test, 2 sided|||||411.0|13.3|0.037
71016093|NCT01244516|141540295|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set at -5.|Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|2.83|||TWO_SIDED|97.4|-5.91|6.7|||Mixed Models Analysis|Alpha is adjusted to 1.3% based on a Sidak multiplicity correction.|The direction of comparison is AAHP - AOA.|This comparison is between galyfilcon and lotrafilcon B. Ho: galyfilcon A -lotrafilcon B \<= -5. Ha: galyfilcon A - lotrafilcon B \> -5.||6.70|-5.91|
71016094|NCT01244516|141540295|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set at -5.|Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|2.79|||TWO_SIDED|97.4|-5.96|6.79|||Mixed Models Analysis|Alpha is adjusted to 1.3% based on a Sidak multiplicity correction.|The direction of comparison is AAHP - BIO.|This comparison is between galyfilcon A and comfilcon A. Ho: gayfilcon A- comfilcon A \<= -5. Ha: galyfilcon A- comfilcon A\> -5.||6.79|-5.96|
71016095|NCT01244516|141540296|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set at \> 0.75. Superiority is concluded is the 97.4% CL \> 1.|Odds Ratio (OR)|1.66|||||TWO_SIDED|97.4|1.14|2.44|||Regression, Logistic|Alpha is adjusted to 1.3% based on a Sidak multiplicity correction.|The direction of comparison is AAHP/AOA.|The comparison is between galyfilcon A (AAHP) and lotrafilcon B (AOA) for comparing proportions of those with corneal staining and those without. Ho: OR = 1 for (AAHP/AOA). Ha: OR \> 1 for (AAHP/AOA).||2.44|1.14|
71016096|NCT01244516|141540296|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set at \> 0.75. Superiority is concluded is the 97.4% CL \> 1.|Odds Ratio (OR)|1.66|||||TWO_SIDED|97.4|1.14|2.44|||Regression, Logistic|Alpha is adjusted to 1.3% based on a Sidak multiplicity correction.||The comparison is between galyfilcon A (AAHP) and comfilcon A (BIO) for comparing proportions of those with corneal staining and those without. Ho: OR = 1 for (AAHP/BIO). Ha: OR \> 1 for (AAHP/BIO).||2.44|1.14|
71016097|NCT03387267|141540302|OTHER||AUC under ROC curve|0.64|||||ONE_SIDED|95.0||0.72||||||||0.72||
71016098|NCT03387267|141540303|OTHER||AUC under ROC curve|0.65|||||TWO_SIDED|||||||||||||
71016099|NCT03387267|141540304|OTHER||AUC under ROC curve|0.576|||||TWO_SIDED|||||||||||||
71016100|NCT03159611|141540324|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
71016101|NCT03159611|141540325|SUPERIORITY|||||||0.005|||||||Cochran-Mantel-Haenszel|||||||0.005
71016102|NCT03159611|141540326|SUPERIORITY|||||||0.5|||||||Mixed Models Analysis|||||||0.50
71016103|NCT03159611|141540327|SUPERIORITY|||||||0.2|||||||Cochran-Mantel-Haenszel|||||||0.20
71016104|NCT03159611|141540328|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
70930327|NCT05247034|141358787|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71049986|NCT02504671|141606197|OTHER||Mean Difference (Net)|1.28||||0.606|TWO_SIDED|95.0|-3.63|6.2||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, PCS|||6.20|-3.63|0.606
71049987|NCT02504671|141606197|OTHER||Mean Difference (Net)|2.46||||0.32|TWO_SIDED|95.0|-2.41|7.32||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, PCS|||7.32|-2.41|0.320
71049988|NCT02504671|141606197|OTHER||Mean Difference (Net)|-0.5||||0.811|TWO_SIDED|95.0|-4.65|3.64||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, MCS|||3.64|-4.65|0.811
71049989|NCT02504671|141606197|OTHER||Mean Difference (Net)|0.45||||0.83|TWO_SIDED|95.0|-3.65|4.55||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, MCS|||4.55|-3.65|0.830
71049990|NCT02504671|141606197|OTHER||Mean Difference (Net)|-0.54||||0.795|TWO_SIDED|95.0|-4.61|3.54||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, MCS|||3.54|-4.61|0.795
71049991|NCT02504671|141606197|OTHER||Mean Difference (Net)|1.32||||0.548|TWO_SIDED|95.0|-3.0|5.64||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, MCS|||5.64|-3.00|0.548
71049992|NCT02504671|141606197|OTHER||Mean Difference (Net)|1.46||||0.505|TWO_SIDED|95.0|-2.85|5.77||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, MCS|||5.77|-2.85|0.505
71049993|NCT02504671|141606197|OTHER||Mean Difference (Net)|1.12||||0.605|TWO_SIDED|95.0|-3.15|5.39||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, MCS|||5.39|-3.15|0.605
71049994|NCT02504671|141606197|OTHER||Mean Difference (Net)|0.43||||0.895|TWO_SIDED|95.0|-6.03|6.9||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, MCS|||6.90|-6.03|0.895
71049995|NCT02504671|141606197|OTHER||Mean Difference (Net)|2.29||||0.461|TWO_SIDED|95.0|-3.84|8.42||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, MCS|||8.42|-3.84|0.461
71049996|NCT02504671|141606197|OTHER||Mean Difference (Net)|-1.05||||0.732|TWO_SIDED|95.0|-7.1|4.99||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, MCS|||4.99|-7.10|0.732
71049997|NCT02504671|141606197|OTHER||Mean Difference (Net)|-0.11||||0.941|TWO_SIDED|95.0|-3.11|2.88||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Bodily Pain|||2.88|-3.11|0.941
71049998|NCT02504671|141606197|OTHER||Mean Difference (Net)|3.73||||0.013|TWO_SIDED|95.0|0.78|6.67||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Bodily Pain|||6.67|0.78|0.013
71104768|NCT01098747|141716679|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.04||||0.667|TWO_SIDED|95.0|-0.15|0.24||p-value was calculated using the PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||0.24|-0.15|0.667
70930328|NCT05247034|141358788|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
71049999|NCT02504671|141606197|OTHER||Mean Difference (Net)|2.92||||0.051|TWO_SIDED|95.0|-0.01|5.84||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Bodily Pain|||5.84|-0.01|0.051
71050000|NCT02504671|141606197|OTHER||Mean Difference (Net)|1.53||||0.403|TWO_SIDED|95.0|-2.07|5.12||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Bodily Pain|||5.12|-2.07|0.403
71050001|NCT02504671|141606197|OTHER||Mean Difference (Net)|2.82||||0.122|TWO_SIDED|95.0|-0.76|6.4||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Bodily Pain|||6.40|-0.76|0.122
71050002|NCT02504671|141606197|OTHER||Mean Difference (Net)|2.08||||0.247|TWO_SIDED|95.0|-1.45|5.62||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Bodily Pain|||5.62|-1.45|0.247
70930329|NCT05247034|141358788|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71050003|NCT02504671|141606197|OTHER||Mean Difference (Net)|2.85||||0.384|TWO_SIDED|95.0|-3.61|9.32||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Bodily Pain|||9.32|-3.61|0.384
71050004|NCT02504671|141606197|OTHER||Mean Difference (Net)|5.05||||0.105|TWO_SIDED|95.0|-1.07|11.16||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Bodily Pain|||11.16|-1.07|0.105
71050005|NCT02504671|141606197|OTHER||Mean Difference (Net)|3.21||||0.29|TWO_SIDED|95.0|-2.76|9.17||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Bodily Pain|||9.17|-2.76|0.290
71104769|NCT00189423|141716680|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.019|TWO_SIDED|95.0|1.07|2.36|||Fisher Exact|||||2.36|1.07|0.019
71104770|NCT00189423|141716681|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin of 5%||||||0.0001|TWO_SIDED|95.0||||p value is for non-inferiority with a margin of 5% (exact binomial test)|Fisher Exact test, for non-inferiority|||||||0.0001
71104771|NCT00189423|141716681|SUPERIORITY_OR_OTHER|||||||0.681|TWO_SIDED|95.0|||||Fisher Exact|||||||0.681
70930330|NCT05247034|141358788|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
70930331|NCT05247034|141358789|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
70930332|NCT05247034|141358789|OTHER|||||||0.0007|||||||Wilcoxon (Mann-Whitney)|||||||0.0007
70930333|NCT05247034|141358789|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71104772|NCT00189423|141716687|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED|95.0|||||Fisher Exact|||||||0.024
71104773|NCT03309202|141716811|OTHER||Mean Difference (Final Values)|130.47|||||TWO_SIDED|90.0|101.57|167.6|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 2 (Mild Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||167.60|101.57|
70930334|NCT06356285|141358817|EQUIVALENCE|Quasibinominal models were used as the outcomes are bounded count variables. Accepting a two-sided p-value adjusted for 3 comparisons, the study was designed with 80% power to detect a minimal detectable effect size between the trial arms and control for the primary outcome.|Odds Ratio, log|0.05||||0.017|TWO_SIDED|95.0||||A two-sided p-value, as shown in the table, which was adjusted for 3 comparisons|Quasibinominal regression|||||||0.017
70930335|NCT01223352|141358887|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.85|||||TWO_SIDED|95.0|0.61|1.2||No statistical test of hypothesis was set for this study. The analysis of PK data was carried out descriptively|||b.i.d. bosentan regimen was taken as reference|||1.20|0.61|
70930336|NCT01223352|141358888|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.71|||||TWO_SIDED|95.0|0.48|1.05||No statistical hypothesis tests were set for this study. The analysis of PK data was carried out descriptively.|||b.i.d. bosentan regimen was taken as reference|||1.05|0.48|
71016105|NCT01418365|141540343|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean ratio|0.979|||||TWO_SIDED|90.0|0.961|0.998|||ANOVA|||||0.998|0.961|
71016106|NCT01418365|141540344|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean Ratio|0.993|||||TWO_SIDED|90.0|0.951|1.04|||ANOVA|||||1.04|0.951|
71016107|NCT03000075|141540347|OTHER|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant psoriatic arthritis (PsA) at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.|Adjusted percentage difference|73.6|||<|0.001|TWO_SIDED|95.0|62.2|85.0||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% confidence interval (CI) for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||85.0|62.2|< 0.001
71104774|NCT03309202|141716811|OTHER||Mean Difference (Final Values)|117.49|||||TWO_SIDED|90.0|91.46|150.93|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 3 (Moderate Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||150.93|91.46|
71104775|NCT03309202|141716811|OTHER||Mean Difference (Final Values)|130.55|||||TWO_SIDED|90.0|101.63|167.7|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 4 (Severe Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||167.70|101.63|
70850685|NCT04518995|141189572|SUPERIORITY||LS Mean Difference|-14.9|STANDARD_ERROR_OF_MEAN|2.34|<|0.0001|TWO_SIDED|95.0|-19.5|-10.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 8||-10.3|-19.5|<0.0001
70930337|NCT04623775|141358895|SUPERIORITY||Risk Difference (RD)|-6.5|||||TWO_SIDED|95.0|-16.0|3.0||||||||3.0|-16.0|
71050006|NCT02504671|141606197|OTHER||Mean Difference (Net)|-0.51||||0.738|TWO_SIDED|95.0|-3.52|2.5||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, General Health|||2.50|-3.52|0.738
70930338|NCT04623775|141358896|SUPERIORITY||Odds Ratio (OR)|1.39|||||TWO_SIDED|90.0|0.94|2.05|||Cochran-Mantel-Haenszel|||||2.05|0.94|
70930339|NCT03969563|141358927|EQUIVALENCE|Equivalence based on non-significant difference between MBSR and Brain Health groups.|Mean Difference (Final Values)|0.3||||0.694|TWO_SIDED||||||Mixed Models Analysis|||||||.694
70930340|NCT03969563|141358928|EQUIVALENCE|Equivalence based on non-significant difference between MBSR vs Brain Health group.|Mean Difference (Final Values)|-1.4||||0.837|TWO_SIDED||||||Mixed Models Analysis|||||||.837
70930341|NCT01474122|141358929|SUPERIORITY_OR_OTHER_LEGACY||NB-2 estimate of new DUs per patient|1.194||||0.434|TWO_SIDED|95.0|0.766|1.861|||negative binomial-2 regression (NB-2)||The estimated value corresponds to the treatment effect i.e. the ratio between the estimated number of new DUs in macitentan 3 mg and in placebo|||1.861|0.766|0.434
71050007|NCT02504671|141606197|OTHER||Mean Difference (Net)|0.99||||0.513|TWO_SIDED|95.0|-1.99|3.97||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, General Health|||3.97|-1.99|0.513
71050008|NCT02504671|141606197|OTHER||Mean Difference (Net)|0.12||||0.934|TWO_SIDED|95.0|-2.83|3.08||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, General Health|||3.08|-2.83|0.934
71050009|NCT02504671|141606197|OTHER||Mean Difference (Net)|0.63||||0.687|TWO_SIDED|95.0|-2.43|3.68||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, General Health|||3.68|-2.43|0.687
71050010|NCT02504671|141606197|OTHER||Mean Difference (Net)|1.85||||0.233|TWO_SIDED|95.0|-1.2|4.91||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, General Health|||4.91|-1.20|0.233
71050011|NCT02504671|141606197|OTHER||Mean Difference (Net)|0.57||||0.708|TWO_SIDED|95.0|-2.44|3.59||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, General Health|||3.59|-2.44|0.708
71050012|NCT02504671|141606197|OTHER||Mean Difference (Net)|3.29||||0.25|TWO_SIDED|95.0|-2.34|8.93||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, General Health|||8.93|-2.34|0.250
71050013|NCT02504671|141606197|OTHER||Mean Difference (Net)|2.76||||0.307|TWO_SIDED|95.0|-2.57|8.09||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, General Health|||8.09|-2.57|0.307
70930342|NCT01474122|141358929|SUPERIORITY_OR_OTHER_LEGACY||NB-2 estimate of new DUs per patient|1.208||||0.407|TWO_SIDED|95.0|0.773|1.886|||NB-2||The estimated value corresponds to the treatment effect i.e. the ratio between the estimated number of new DUs in macitentan 10 mg and in placebo|||1.886|0.773|0.407
70930343|NCT01474122|141358930|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.831||||0.5668|TWO_SIDED|95.0|0.442|1.564|||Chi-squared|||||1.564|0.442|0.5668
70930344|NCT01474122|141358930|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.789||||0.4624|TWO_SIDED|95.0|0.42|1.484|||Chi-squared|||||1.484|0.420|0.4624
70930345|NCT01474122|141358931|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.216||||0.6117|TWO_SIDED|95.0|0.572|2.582|||Chi-squared|||||2.582|0.572|0.6117
71016108|NCT03000075|141540347|OTHER|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.|Adjusted percentage difference|72.4|||<|0.001|TWO_SIDED|95.0|60.6|84.1||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||84.1|60.6|< 0.001
71016109|NCT03000075|141540349|OTHER||Adjusted percentage difference|75.0|||<|0.001|TWO_SIDED|95.0|63.8|86.2||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||86.2|63.8|< 0.001
71104776|NCT03309202|141716812|OTHER||Mean Difference (Final Values)|136.37|||||TWO_SIDED|90.0|94.63|196.53|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 2 (Mild Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||196.53|94.63|
71104777|NCT03309202|141716812|OTHER||Mean Difference (Final Values)|124.23|||||TWO_SIDED|90.0|86.2|179.03|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 3 (Moderate Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||179.03|86.20|
71104778|NCT03309202|141716812|OTHER||Mean Difference (Final Values)|118.65|||||TWO_SIDED|90.0|82.33|170.99|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 4 (Severe Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||170.99|82.33|
71104779|NCT03309202|141716813|OTHER||Mean Difference (Final Values)|124.7309|||||TWO_SIDED|90.0|82.5275|188.5165|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 2 (Mild Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||188.5165|82.5275|
71104780|NCT03309202|141716813|OTHER||Mean Difference (Final Values)|147.0778|||||TWO_SIDED|90.0|97.3132|222.2911|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 3 (Moderate Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||222.2911|97.3132|
71104781|NCT03309202|141716813|OTHER||Mean Difference (Final Values)|224.7373|||||TWO_SIDED|90.0|148.6962|339.6647|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 4 (Severe Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||339.6647|148.6962|
71104782|NCT03309202|141716814|OTHER||Mean Difference (Final Values)|162.58|||||TWO_SIDED|90.0|103.12|256.32|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 2 (Mild Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||256.32|103.12|
71104783|NCT03309202|141716814|OTHER||Mean Difference (Final Values)|172.74|||||TWO_SIDED|90.0|109.56|272.35|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 3 (Moderate Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||272.35|109.56|
71104784|NCT03309202|141716814|OTHER||Mean Difference (Final Values)|293.31|||||TWO_SIDED|90.0|186.04|462.44|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 4 (Severe Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||462.44|186.04|
70930346|NCT01474122|141358931|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.048||||0.9047|TWO_SIDED|95.0|0.485|2.264|||Chi-squared|||||2.264|0.485|0.9047
70930347|NCT01474122|141358932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.347|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.347
70930348|NCT01474122|141358932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.165|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.165
70930349|NCT01474122|141358933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.339|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.339
70930350|NCT01474122|141358933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.312|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.312
70930351|NCT01474122|141358934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.319|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.319
70930352|NCT01474122|141358934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.2||||0.221|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.221
70930353|NCT04173247|141358942|OTHER|A t-test with 180 degrees of freedom to compare the mean DLQI score over the 6 weeks in arm1 to the mean DLQI score over six weeks in arm2.||||||0.28|||||||t-test, 1 sided|||||||0.28
70930354|NCT04214834|141358946|SUPERIORITY||Mean Difference (Final Values)|2.96|||<|0.001|TWO_SIDED|95.0|1.7|4.29|||Mixed Models Analysis||Given that the model was on the log scale, mean difference and 95% confidence interval were derived from 1,000 bootstrap resamples.|A logarithmic transformation was applied to the outcome, centers were added as random effects to account for variation between them.||4.29|1.70|<0.001
70930355|NCT03884101|141358967|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.5550121|TWO_SIDED|95.0|0.83|1.24|||Log Rank|One-sided p-value based on log-rank test and stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|||1.24|0.83|0.5550121
71016110|NCT03000075|141540349|OTHER||Adjusted percentage difference|82.4|||<|0.001|TWO_SIDED|95.0|72.2|92.6||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||92.6|72.2|< 0.001
71016111|NCT03000075|141540351|OTHER||Adjusted percentage difference|80.3|||<|0.001|TWO_SIDED|95.0|70.1|90.4||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||90.4|70.1|< 0.001
71029447|NCT01347710|141566735|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.984|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; Non-LAD|z Test|z test for non-inferiority for specificity; non-LAD||||||.984
71104785|NCT03309202|141716815|OTHER||Mean Difference (Final Values)|169.84|||||TWO_SIDED|90.0|104.02|277.32|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 2 (Mild Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||277.32|104.02|
71104786|NCT03309202|141716815|OTHER||Mean Difference (Final Values)|182.51|||||TWO_SIDED|90.0|111.78|298.02|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 3 (Moderate Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||298.02|111.78|
71104787|NCT03309202|141716815|OTHER||Mean Difference (Final Values)|266.29|||||TWO_SIDED|90.0|163.08|434.8|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 4 (Severe Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||434.80|163.08|
71104788|NCT04734210|141716836|OTHER|Exploratory, descriptive analysis||||||0.2933||||||The difference in response rates between each of the SURF-200 formulations and vehicle was compared by Fisher's exact method.|Fisher Exact|The threshold for statistical significance is p=0.05.||Exploratory Phase 2 Study; approximately 120 subjects (approximately 40 subjects per each of the 3 treatment groups) were planned to be enrolled in the study. The sample size was based on medical judgment. No formal sample size calculation was performed, and the sample size was empirical. However, the sample size selected was considered sufficient to adequately characterize the general safety and efficacy profile of the study treatments.||||0.2933
71104789|NCT04734210|141716837|OTHER|Exploratory, descriptive analysis||||||0.1966||||||The difference in response rates between each of the SURF-200 formulations and vehicle was compared by Fisher's exact method.|Fisher Exact|The threshold for statistical significance is p=0.05.||Exploratory Phase 2 Study; approximately 120 subjects (approximately 40 subjects per each of the 3 treatment groups) were planned to be enrolled in the study. The sample size was based on medical judgment. No formal sample size calculation was performed, and the sample size was empirical. However, the sample size selected was considered sufficient to adequately characterize the general safety and efficacy profile of the study treatments.||||0.1966
71104790|NCT04734210|141716838|OTHER|Exploratory, descriptive analysis||||||0.0213||||||The difference in response rates between each of the SURF-200 formulations and vehicle was compared by Fisher's exact method.|Fisher Exact|The threshold for statistical significance is p=0.05.||Exploratory Phase 2 Study; approximately 120 subjects (approximately 40 subjects per each of the 3 treatment groups) were planned to be enrolled in the study. The sample size was based on medical judgment. No formal sample size calculation was performed, and the sample size was empirical. However, the sample size selected was considered sufficient to adequately characterize the general safety and efficacy profile of the study treatments.||||0.0213
71104791|NCT02138825|141716846|SUPERIORITY_OR_OTHER||LS mean difference|21.48||||0.2074|TWO_SIDED|95.0|-8.75|51.71|||ANCOVA|||The evaluation of primary efficacy endpoint will be based on change from baseline in 6MWD using analysis of covariance (ANCOVA) with baseline 6MWD, treatment arm and region as factors.||51.71|-8.75|0.2074
71104792|NCT02138825|141716847|SUPERIORITY_OR_OTHER|||||||0.3437|||||||Mantel Haenszel|||The difference in incidences in clinical worsening and mortality will be analyzed using Mantel-Haenszel weights, stratified by region.||||0.3437
71104793|NCT01690273|141716851|SUPERIORITY_OR_OTHER|||||||0.13|||||||Mixed Models Analysis|||||||0.13
71104794|NCT01690273|141716851|SUPERIORITY_OR_OTHER|||||||0.99|||||||Mixed Models Analysis|||||||0.99
71104795|NCT01690273|141716851|SUPERIORITY_OR_OTHER|||||||0.11|||||||Mixed Models Analysis|||||||0.11
71104796|NCT01690273|141716851|SUPERIORITY_OR_OTHER|||||||0.9913|||||||Mixed Models Analysis|||||||0.9913
70930356|NCT03884101|141358968|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.1792058|TWO_SIDED|95.0|0.77|1.1|||Log Rank|One-sided p-value based on log-rank test and stratified by MMR status, ECOG performance status, and prior chemotherapy and/or chemoradiation.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate stratified by MMR status, ECOG performance status, and prior chemotherapy and/or chemoradiation.|||1.10|0.77|0.1792058
70930357|NCT03884101|141358969|NON_INFERIORITY|The null hypothesis for the non-inferiority test was that the hazard ratio was equal to 1.1.|Hazard Ratio (HR)|1.02||||0.2459875|TWO_SIDED|95.0|0.83|1.26|||Log Rank|One-sided p-value based on log-rank test and stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|||1.26|0.83|0.2459875
71104797|NCT01690273|141716851|SUPERIORITY_OR_OTHER|||||||0.0427|||||||Mixed Models Analysis|||||||0.0427
70930358|NCT03884101|141358969|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.5875597|TWO_SIDED|95.0|0.83|1.26|||Log Rank|One-sided p-value based on log-rank test and stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|||1.26|0.83|0.5875597
71104798|NCT01690273|141716851|SUPERIORITY_OR_OTHER|||||||0.1856|||||||Mixed Models Analysis|||||||0.1856
71104799|NCT01690273|141716852|SUPERIORITY_OR_OTHER|||||||0.04|||||||Mixed Models Analysis|||||||0.04
71104800|NCT01690273|141716852|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Mixed Models Analysis|||||||0.0002
71104801|NCT01690273|141716852|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Mixed Models Analysis|||||||0.0002
71104802|NCT01690273|141716852|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
71104803|NCT01690273|141716852|SUPERIORITY_OR_OTHER|||||||0.935|||||||Mixed Models Analysis|||||||0.935
71104804|NCT01690273|141716852|SUPERIORITY_OR_OTHER|||||||0.876|||||||Mixed Models Analysis|||||||0.876
71104805|NCT01690273|141716853|SUPERIORITY_OR_OTHER|||||||0.004|||||||Mixed Models Analysis|||||||0.004
71029448|NCT01347710|141566736|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value of sensitivity for flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule; multivessel disease|McNemar|p-Value based on two-sided McNemar's (Chi squared) test superiority||||||<0.001
71029449|NCT01347710|141566737|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.827|TWO_SIDED|||||p-Value of specificity for comparison of flurpiridaz F18 PET MPI vs. SPECT MPI in detecting multivessel disease|z test|p-Value based on one-sided z test for non-inferiority||||||0.827
71029450|NCT01347710|141566738|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule; image quality of excellent or good|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority for sensitivity||||||<0.001
71029451|NCT01347710|141566739|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study protocol number BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.945|ONE_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI|Z Test|one-sided z test for non-inferiority for specificity||||||.945
71029452|NCT01347710|141566740|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.954|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule; image quality excellent/good|z Test|p-Value based on on-sided z test for non-inferiority for specificity||||||0.954
71029453|NCT01347710|141566741|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Log Rank|||||||<0.001
71029454|NCT01347710|141566742|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||McNemar|p-Values are from 2-sided McNemar's test of comparison in proportion of patients with definitely diagnositic certainty between PET and SPECT||||||<0.001
71029455|NCT01968382|141566748|SUPERIORITY|||||||0.3198|||||||ANOVA|||||||0.3198
71029456|NCT01968382|141566751|SUPERIORITY|||||||0.8462|||||||ANOVA|||||||0.8462
71029457|NCT00970281|141566767|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value was based on an analysis of variance (ANOVA) model that included treatment and site as a factor.|ANOVA|||Sample size of at least 45 participants per group was necessary to verify decreases in PANSS-EC total score were significantly greater in olanzapine group than placebo group using a t-test with a power of 90% and a 2-sided significance level of 5%.||||<0.001
71029458|NCT00970281|141566768|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||This is the p-value for 0.25 hour after first IM injection.|ANOVA|||||||0.009
71029459|NCT00970281|141566768|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 0.50 hour after first IM injection.|ANOVA|||||||<0.001
71029460|NCT00970281|141566768|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 1 hour after first IM injection.|ANOVA|||||||<0.001
71029461|NCT00970281|141566768|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 1.5 hour after first IM injection.|ANOVA|||||||<0.001
71029462|NCT00970281|141566769|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||ANOVA|||||||0.008
71029463|NCT00970281|141566770|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Fisher Exact|||||||0.008
71029464|NCT00970281|141566771|SUPERIORITY_OR_OTHER|||||||0.167||95.0||||This is the p-value for the 0.5 hour after the first IM injection.|Fisher Exact|||||||0.167
71029465|NCT00970281|141566771|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||This is the p-value for the 1 hour after the first IM injection.|Fisher Exact|||||||0.134
71029466|NCT00970281|141566771|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||This is the p-value for the 1.5 hour after the first IM injection.|Fisher Exact|||||||0.008
71029467|NCT00970281|141566771|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||This is the p-value for the 2 hours after the first IM injection.|Fisher Exact|||||||0.008
71029468|NCT00970281|141566771|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||This is the p-value for the 24 hours after the first IM injection.|Fisher Exact|||||||0.204
71029469|NCT00970281|141566772|SUPERIORITY_OR_OTHER|||||||1||95.0||||This is the p-value for Parkinsonism.|Fisher Exact|||||||1.000
70930359|NCT03884101|141358970|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.21552|TWO_SIDED|95.0|0.77|1.12|||Log Rank|One-sided p-value based on log-rank test and stratified by MMR status, ECOG performance status, and prior chemotherapy and/or chemoradiation.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate stratified by MMR status, ECOG performance status, and prior chemotherapy and/or chemoradiation.|||1.12|0.77|0.21552
70930360|NCT03884101|141358971|OTHER||Difference in Percentage|-4.2||||0.8569|TWO_SIDED|95.0|-11.9|3.5|||Stratified Miettinen & Nurminen|One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Based on Miettinen \& Nurminen method stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|||3.5|-11.9|0.8569
70930361|NCT03884101|141358972|OTHER||Difference in Percentage|0.0||||0.4999|TWO_SIDED|95.0|-6.7|6.7|||Stratified Miettinen & Nurminen|One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Based on Miettinen \& Nurminen method stratified by MMR status, ECOG performance status, and prior chemotherapy and/or chemoradiation.|||6.7|-6.7|0.4999
70930362|NCT03884101|141358973|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors ECOG performance status, and prior chemotherapy and/or chemoradiation.|Difference in Least Square Means|-3.77||||0.0302|TWO_SIDED|95.0|-7.17|-0.36|||cLDA model|||||-0.36|-7.17|0.0302
70930363|NCT03884101|141358974|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors MMR status, ECOG performance status, and prior chemotherapy and/or chemoradiation.|Difference in Least Square Means|-2.29||||0.1355|TWO_SIDED|95.0|-5.31|0.72|||cLDA model|||||0.72|-5.31|0.1355
70930364|NCT03370913|141358979|SUPERIORITY||% Reduction from Baseline|-77.0|||<|0.0001|TWO_SIDED|||||P-values were for 2-sided test against 0.|t-test, 2 sided|Superiority was tested by1-sample t-test to test null hypothesis that change is \>=0. Only negative changes represent efficacy.|77% reduction|Change from baseline in the ABR for all bleeds (post-baseline EEP value - baseline value)||||<0.0001
70930365|NCT06097494|141358989|SUPERIORITY||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|1.01|1.15|||||Calculated as the odds of a person diagnosed with vitiligo having with depression versus people not diagnosed with vitiligo|||1.15|1.01|
70930366|NCT06097494|141358990|SUPERIORITY||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|1.09|1.3|||||Calculated as the odds of people diagnosed with vitiligo having anxiety compared to people not diagnosed with vitilligo.|||1.30|1.09|
70930367|NCT06097494|141358991|SUPERIORITY||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|1.03|1.17|||||Calculated as the odds of people diagnosed with vitiligo having anxiety or depression compared to people not diagnosed with vitilligo.|||1.17|1.03|
70930368|NCT06097494|141358992|SUPERIORITY||Incidence rate ratio|1.29|||||TWO_SIDED|95.0|1.26|1.32|||||Adjusted incident rate ratio for increased primary care use was calculated by comparing patients with vitiligo versus matched controls not having vitiligo,using negative binomial regression.|||1.32|1.26|
71016112|NCT03000075|141540351|OTHER||Adjusted percentage difference|86.0|||<|0.001|TWO_SIDED|95.0|76.8|95.1||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||95.1|76.8|< 0.001
70930369|NCT06097494|141358994|OTHER||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.93|1.2|||||Hazard ratios for mental health referrals was calculated using Cox proportional hazards regression model and reflect a comparison of the incidence rates between people diagnosed with vitiligo and people not diagnosed with vitiligo.|||1.20|0.93|
70930370|NCT06097494|141358995|OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.76|1.15|||||Hazard ratios for unemployment was calculated using Cox proportional hazards regression model and reflect a comparison of the incidence rates between people diagnosed with vitiligo and people not diagnosed with vitiligo.|||1.15|0.76|
70930371|NCT06097494|141358996|OTHER||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|1.06|1.24|||||Hazard ratios for time off work was calculated using Cox proportional hazards regression model and reflect a comparison of the incidence rates between people diagnosed with vitiligo and people not diagnosed with vitiligo.|||1.24|1.06|
71016113|NCT03000075|141540353|OTHER||Adjusted percentage difference|22.6|||<|0.001|TWO_SIDED|95.0|11.8|33.4||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||33.4|11.8|< 0.001
70850686|NCT04518995|141189572|SUPERIORITY||LS Mean Difference|-21.7|STANDARD_ERROR_OF_MEAN|2.94|<|0.0001|TWO_SIDED|95.0|-27.5|-16.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-16.0|-27.5|<0.0001
70930372|NCT06097494|141358997|OTHER||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|1.02|1.31|||||Hazard ratios for sleep disturbance was calculated using Cox proportional hazards regression model and reflect a comparison of the incidence rates between people diagnosed with vitiligo and people not diagnosed with vitiligo.|||1.31|1.02|
71029470|NCT00113425|141566776|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|95.0|||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in papule acne lesions for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.01
70930373|NCT05683158|141358998|OTHER||Mean Difference (Net)|1.71|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED||||||ANOVA||Mean difference between two groups of movement unit in forward direction|To determine the sample size, the G\*Power software was utilized, incorporating an effect size (d) of 1.9, alpha level of 0.05, and power of 0.8. A sample size of six individuals per group was considered sufficient to achieve adequate statistical power, which are α ≤ 0.05, power = 0.8, and β = 0.2.||||<.001
71104806|NCT01690273|141716853|SUPERIORITY_OR_OTHER|||||||0.87|||||||Mixed Models Analysis|||||||0.87
71104807|NCT01690273|141716853|SUPERIORITY_OR_OTHER|||||||0.83|||||||Mixed Models Analysis|||||||0.83
70930374|NCT05683158|141358998|OTHER||Mean Difference (Net)|0.44|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED||||||ANOVA||Statistics difference among forward, ipsilateral and contralateral directions in within group|To determine the sample size, the G\*Power software was utilized, incorporating an effect size (d) of 1.9, alpha level of 0.05, and power of 0.8. A sample size of six individuals per group was considered sufficient to achieve adequate statistical power, which are α ≤ 0.05, power = 0.8, and β = 0.2.||||<.001
71016114|NCT03000075|141540353|OTHER||Adjusted percentage difference|32.5|||<|0.001|TWO_SIDED|95.0|20.0|45.0||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||45.0|20.0|< 0.001
71016115|NCT03000075|141540355|OTHER||Adjusted percentage difference|39.2||||0.131|TWO_SIDED|95.0|-11.6|90.1||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||90.1|-11.6|0.131
71104808|NCT01690273|141716853|SUPERIORITY_OR_OTHER|||||||0.989|||||||Mixed Models Analysis|||||||0.989
70930375|NCT04679389|141359039|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
70930376|NCT04679389|141359040|SUPERIORITY|||||||0.48|||||||Fisher Exact|||||||0.48
71016116|NCT03000075|141540355|OTHER|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.|Adjusted percentage difference|31.3||||0.269|TWO_SIDED|95.0|-24.2|86.7||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||86.7|-24.2|0.269
71016117|NCT00440193|141540357|NON_INFERIORITY_OR_EQUIVALENCE|Assuming equal efficacy, a total of 88 events was calculated to give a power of 90% to prove that rivaroxaban is at least as effective as the comparator, considering a non-inferiority upper CI margin for the hazard ratio of 2.0 (two-sided α=0.05). A mean incidence for the primary efficacy outcome of 3% was expected and at least 1465 participants per group were determined to be necessary. This number was to be adjusted based on the observed overall incidence of symptomatic recurrent VTE.|Hazard Ratio (HR)|0.68|STANDARD_ERROR_OF_MEAN|0.2179|<|0.0001||95.0|0.44|1.04|||Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline|The standard error of the log hazard ratio was estimated.|The rivaroxaban to comparator hazard ratio was computed with a 95% CI (confidence interval) (two-sided testing). Based on this model, rivaroxaban would be considered at least as effective as the comparator if the upper limit of the CI was less than 2.0.||1.04|0.44|< 0.0001
71016118|NCT00440193|141540358|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|STANDARD_ERROR_OF_MEAN|0.1616||0.044||95.0|0.53|0.99||Nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.|||0.99|0.53|0.044
71016119|NCT00440193|141540359|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67|STANDARD_ERROR_OF_MEAN|0.1828||0.027||95.0|0.47|0.95||Nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.|||0.95|0.47|0.027
71016120|NCT00440193|141540361|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97|STANDARD_ERROR_OF_MEAN|0.1204||0.77||95.0|0.76|1.22||Nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.|||1.22|0.76|0.77
71016121|NCT02222168|141540374|OTHER|The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 fed' was an Analysis of Variance (ANOVA ) model on the logarithmic scale.This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio (Fed/Fasted)|95.9|STANDARD_ERROR_OF_MEAN|50.7|||TWO_SIDED|90.0|72.593|126.682|||||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 409306: fed (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \[%\].|No formal hypothesis was tested.||126.682|72.593|
71029471|NCT00113425|141566777|SUPERIORITY_OR_OTHER|||||||0.43|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in pustule acne lesions for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.43
71029472|NCT00113425|141566778|SUPERIORITY_OR_OTHER|||||||0.79|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in cysts for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.79
71029473|NCT00113425|141566779|SUPERIORITY_OR_OTHER|||||||0.1|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in closed comedones for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.10
71029474|NCT00113425|141566780|SUPERIORITY_OR_OTHER|||||||0.73|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in open comedones for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.73
71029475|NCT00113425|141566781|SUPERIORITY_OR_OTHER|||||||0.02|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in erythematous macules for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.02
70930377|NCT04679389|141359041|SUPERIORITY|||||||0.48|||||||Fisher Exact|||||||0.48
70930378|NCT04679389|141359042|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
70930379|NCT04679389|141359045|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||||||0.31
70930380|NCT04679389|141359046|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
70930381|NCT05541484|141359049|OTHER|Spearman's ρ given non-normal variable distributions|||||<|0.0001||||||Spearman's ρ given non-normal variable distributions|Wilcoxon (Mann-Whitney)|||||||< 0.0001
70930382|NCT03279978|141359056|OTHER||Slope|0.7124|STANDARD_ERROR_OF_MEAN|0.0694|||TWO_SIDED|95.0|0.5702|0.8546||||||Dose proportionality for AUC0-24 of BI 730357 in plasma - fasted groups was assessed using a power model (regression model applied to log-transformed data). In this study AUCtau,1 = AUC0-24|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.8546|0.5702|
70930383|NCT03279978|141359056|OTHER||Slope|0.5964|STANDARD_ERROR_OF_MEAN|0.0575|||TWO_SIDED|95.0|0.4777|0.7151||||||Dose proportionality for AUC0-24 of BI 730357 in plasma - fed groups was assessed using a power model (regression model applied to log-transformed data). In this study AUCtau,1 = AUC0-24|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.7151|0.4777|
70930384|NCT03279978|141359057|OTHER||Slope|0.6445|STANDARD_ERROR_OF_MEAN|0.0649|||TWO_SIDED|95.0|0.5124|0.7766||||||Dose proportionality for Cmax of BI 730357 in plasma - fasted groups was assessed using a power model (regression model applied to log-transformed data).|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.7766|0.5124|
70930385|NCT03279978|141359057|OTHER||Slope|0.6223|STANDARD_ERROR_OF_MEAN|0.0715|||TWO_SIDED|95.0|0.4747|0.7699||||||Dose proportionality for Cmax of BI 730357 in plasma - fed groups was assessed using a power model (regression model applied to log-transformed data).|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.7699|0.4747|
71016122|NCT02222168|141540374|OTHER|The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 at bed-time' was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'subject' and 'treatment'. The effect 'subject' was considered as random, whereas the effect treatment was considered as fixed.|Ratio (Bed time/Fasted)|82.13|STANDARD_ERROR_OF_MEAN|38.0|||TWO_SIDED|90.0|66.37|101.639|||||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 409306: at bed time (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \[%\].|No formal hypothesis was tested.||101.639|66.370|
71016123|NCT02222168|141540375|OTHER|The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 fed' was an Analysis of Variance (ANOVA ) model on the logarithmic scale.This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio (Fed/Fasted)|107.41|STANDARD_ERROR_OF_MEAN|18.2|||TWO_SIDED|90.0|96.697|119.318|||||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 409306: fed (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \[%\].|No formal hypothesis was tested.||119.318|96.697|
71016124|NCT02222168|141540375|OTHER|The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 at bed-time' was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'subject' and 'treatment'. The effect 'subject' was considered as random, whereas the effect treatment was considered as fixed.|Ratio (Bed time/Fasted)|94.88|STANDARD_ERROR_OF_MEAN|19.1|||TWO_SIDED|90.0|85.028|105.875|||||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 409306: at bed time (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \[%\].|No formal hypothesis was tested.||105.875|85.028|
71029476|NCT00113425|141566782|SUPERIORITY_OR_OTHER|||||||0.003|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in acne severity for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.003
71029477|NCT00113425|141566783|SUPERIORITY_OR_OTHER|||||||0.62|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in papule acne lesions for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.62
70930386|NCT03279978|141359058|OTHER||Slope|0.6401|STANDARD_ERROR_OF_MEAN|0.0909|||TWO_SIDED|95.0|0.4545|0.8258||||||Dose proportionality for AUCτ,ss of BI 730357 in plasma - fasted groups was assessed using a power model (regression model applied to log-transformed data).|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.8258|0.4545|
70930387|NCT03279978|141359058|OTHER||Slope|0.5811|STANDARD_ERROR_OF_MEAN|0.0864|||TWO_SIDED|95.0|0.4013|0.7609||||||Dose proportionality for AUCτ,ss of BI 730357 in plasma - fed groups was assessed using a power model (regression model applied to log-transformed data).|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.7609|0.4013|
71029478|NCT00113425|141566784|SUPERIORITY_OR_OTHER|||||||0.85|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in pustule acne lesions for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.85
71050014|NCT02504671|141606197|OTHER||Mean Difference (Net)|2.53||||0.345|TWO_SIDED|95.0|-2.74|7.79||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, General Health|||7.79|-2.74|0.345
71016125|NCT02222168|141540376|OTHER|The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 fed' was an Analysis of Variance (ANOVA ) model on the logarithmic scale.This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio (Fed/Fasted)|107.41|STANDARD_ERROR_OF_MEAN|18.2|||TWO_SIDED|90.0|96.709|119.301|||||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 409306: fed (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \[%\].|No formal hypothesis was tested.||119.301|96.709|
71050015|NCT02504671|141606197|OTHER||Mean Difference (Net)|0.16||||0.95|TWO_SIDED|95.0|-0.19|0.52||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Mental Health|||0.52|-0.19|0.950
71050016|NCT02504671|141606197|OTHER||Mean Difference (Net)|0.88||||0.664|TWO_SIDED|95.0|-3.11|4.87||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Mental Health|||4.87|-3.11|0.664
70850687|NCT04518995|141189572|SUPERIORITY||LS Mean Difference|-30.0|STANDARD_ERROR_OF_MEAN|3.19|<|0.0001|TWO_SIDED|95.0|-36.3|-23.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-23.8|-36.3|<0.0001
70850688|NCT04518995|141189572|SUPERIORITY||LS Mean Difference|-28.4|STANDARD_ERROR_OF_MEAN|3.38|<|0.0001|TWO_SIDED|95.0|-35.1|-21.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-21.8|-35.1|<0.0001
70850689|NCT04518995|141189572|SUPERIORITY||LS Mean Difference|-38.5|STANDARD_ERROR_OF_MEAN|3.66|<|0.0001|TWO_SIDED|95.0|-45.7|-31.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-31.3|-45.7|<0.0001
71016126|NCT02222168|141540376|OTHER|The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 at bed-time' was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'subject' and 'treatment'. The effect 'subject' was considered as random, whereas the effect treatment was considered as fixed.|Ratio (Bed time/Fasted)|94.92|STANDARD_ERROR_OF_MEAN|19.1|||TWO_SIDED|90.0|85.061|105.921|||||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 409306: at bed time (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \[%\].|No formal hypothesis was tested.||105.921|85.061|
70850690|NCT04518995|141189572|SUPERIORITY||LS Mean Difference|-34.9|STANDARD_ERROR_OF_MEAN|3.66|<|0.0001|TWO_SIDED|95.0|-42.1|-27.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-27.7|-42.1|<0.0001
71016127|NCT00530621|141540377|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.13||||0.544||95.0|0.77|1.65||P-value was stratified by Eastern Cooperative Oncology Group (ECOG) performance status and time since last chemotherapy.|Log Rank|||||1.65|0.77|0.544
71016128|NCT00530621|141540378|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7||||0.171||95.0|0.42|1.17||P-value was stratified by Eastern Cooperative Oncology Group (ECOG) performance status and time since last chemotherapy.|Log Rank|||||1.17|0.42|0.171
71016129|NCT00530621|141540379|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.11||||0.01||95.0|1.19|3.75|||Regression, Cox|||||3.75|1.19|0.010
71016130|NCT00530621|141540380|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.5||||0.194||95.0|0.81|2.77||P-value was stratified by Eastern Cooperative Oncology Group (ECOG) performance status score and time since last chemotherapy.|Log Rank|||||2.77|0.81|0.194
71016131|NCT00530621|141540381|SUPERIORITY_OR_OTHER_LEGACY|||||||0.681|||||||Fisher Exact|||||||0.681
71016132|NCT00518011|141540385|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.842||||0.3644|TWO_SIDED|95.0|0.483|7.027|||Log Rank|||||7.027|0.483|0.3644
71104809|NCT01690273|141716853|SUPERIORITY_OR_OTHER|||||||0.022|||||||Mixed Models Analysis|||||||0.022
70850691|NCT04518995|141189572|SUPERIORITY||LS Mean Difference|-44.6|STANDARD_ERROR_OF_MEAN|3.96|<|0.0001|TWO_SIDED|95.0|-52.3|-36.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-36.8|-52.3|<0.0001
70850692|NCT04518995|141189572|SUPERIORITY||LS Mean Difference|-39.3|STANDARD_ERROR_OF_MEAN|3.79|<|0.0001|TWO_SIDED|95.0|-46.7|-31.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-31.8|-46.7|<0.0001
70850693|NCT04518995|141189572|SUPERIORITY||LS Mean Difference|-47.0|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001|TWO_SIDED|95.0|-55.1|-39.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-39.0|-55.1|<0.0001
71016133|NCT00518011|141540389|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.278||||0.7165|TWO_SIDED|95.0|0.339|4.824|||Log Rank|||||4.824|0.339|0.7165
71016134|NCT03409328|141540395|OTHER||F|38.44|||<|0.001|TWO_SIDED||||||ANCOVA|The ANCOVA controlled for baseline levels of the outcome.||||||<.001
71016135|NCT03409328|141540396|OTHER||F|6.69||||0.013|TWO_SIDED||||||ANCOVA|The ANCOVA controlled for baseline levels of the outcome.||||||.013
71016136|NCT03409328|141540397|OTHER||F|5.07||||0.029|TWO_SIDED||||||ANCOVA|The ANCOVA controlled for baseline levels of the outcome.||||||.029
71050017|NCT02504671|141606197|OTHER||Mean Difference (Net)|-0.01||||0.994|TWO_SIDED|95.0|-3.99|3.96||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Mental Health|||3.96|-3.99|0.994
71050018|NCT02504671|141606197|OTHER||Mean Difference (Net)|2.6||||0.25|TWO_SIDED|95.0|-1.84|7.03||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Mental Health|||7.03|-1.84|0.250
71104810|NCT01690273|141716853|SUPERIORITY_OR_OTHER|||||||0.119|||||||Mixed Models Analysis|||||||0.119
71104811|NCT01690273|141716854|SUPERIORITY_OR_OTHER|||||||0.09|||||||Mixed Models Analysis|||||||0.09
71104812|NCT01690273|141716854|SUPERIORITY_OR_OTHER|||||||0.99|||||||Mixed Models Analysis|||||||0.99
70930388|NCT03279978|141359059|OTHER||Slope|0.6005|STANDARD_ERROR_OF_MEAN|0.0722|||TWO_SIDED|95.0|0.4534|0.7477||||||Dose proportionality for Cmax,ss of BI 730357 in plasma - fasted groups was assessed using a power model (regression model applied to log-transformed data).|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.7477|0.4534|
71016137|NCT03409328|141540398|OTHER||F|0.38||||0.542|TWO_SIDED||||||ANCOVA|The ANCOVA controlled for baseline levels of the outcome.||||||.542
71016138|NCT03409328|141540399|OTHER||F|3.12||||0.084|TWO_SIDED||||||ANCOVA|The ANCOVA controlled for baseline levels of the outcome.||The outcome for this analysis is internalized stigma.||||.084
71104813|NCT01690273|141716854|SUPERIORITY_OR_OTHER|||||||0.94|||||||Mixed Models Analysis|||||||0.94
71104814|NCT01690273|141716854|SUPERIORITY_OR_OTHER|||||||0.213|||||||Mixed Models Analysis|||||||0.213
71104815|NCT01690273|141716854|SUPERIORITY_OR_OTHER|||||||0.007|||||||Mixed Models Analysis|||||||0.007
71104816|NCT01690273|141716854|SUPERIORITY_OR_OTHER|||||||0.9|||||||Mixed Models Analysis|||||||0.900
71016139|NCT03409328|141540399|OTHER||F|0.67||||0.417|TWO_SIDED||||||ANCOVA|The ANCOVA controlled for baseline levels of the outcome.||The outcome for this analysis is identity affirmation.||||.417
71016140|NCT03930615|141540412|SUPERIORITY||Treatment Difference|-16.1||||0.0005|TWO_SIDED|95.0|-25.8|-6.5||A one-sided p-value ≤0.0249 was used for declaring statistical significance|Mantel Haenszel|Stratum adjusted|Letermovir minus placebo|It was hypothesized that LET is superior to placebo in the prevention of clinically significant CMV infection.|95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|-6.5|-25.8|0.0005
71016141|NCT03930615|141540413|OTHER||Difference in Percentage|-4.4|||||TWO_SIDED|95.0|-11.8|4.7|||||Letermovir minus Placebo||Miettinen \& Nurminen method|4.7|-11.8|
71016142|NCT03930615|141540414|OTHER||Difference in Percentage|3.5|||||TWO_SIDED|95.0|-2.7|8.6|||||Letermovir minus Placebo||Miettinen \& Nurminen method|8.6|-2.7|
71016143|NCT03930615|141540415|SUPERIORITY||Treatment Difference|-5.7||||0.1591|TWO_SIDED|95.0|-16.8|5.4|||Mantel Haenszel|Stratum adjusted|Letermovir minus placebo||95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|5.4|-16.8|0.1591
71016144|NCT03930615|141540416|SUPERIORITY||Treatment Difference|-5.7||||0.1591|TWO_SIDED|95.0|-16.8|5.4|||Mantel Haenszel|Stratum adjusted|Letermovir minus placebo||95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|5.4|-16.8|0.1591
71104817|NCT01690273|141716855|SUPERIORITY_OR_OTHER|||||||0.003|||||||Mixed Models Analysis|||||||0.003
71104818|NCT01690273|141716855|SUPERIORITY_OR_OTHER|||||||0.99|||||||Mixed Models Analysis|||||||0.99
71104819|NCT01690273|141716855|SUPERIORITY_OR_OTHER|||||||0.69|||||||Mixed Models Analysis|||||||0.69
71104820|NCT01690273|141716855|SUPERIORITY_OR_OTHER|||||||0.874|||||||Mixed Models Analysis|||||||0.874
71104821|NCT01690273|141716855|SUPERIORITY_OR_OTHER|||||||0.057|||||||Mixed Models Analysis|||||||0.057
71104822|NCT01690273|141716855|SUPERIORITY_OR_OTHER|||||||0.526|||||||Mixed Models Analysis|||||||0.526
71104823|NCT01690273|141716856|SUPERIORITY_OR_OTHER|||||||0.853|||||||Mixed Models Analysis|||||||0.853
71104824|NCT01690273|141716856|SUPERIORITY_OR_OTHER|||||||0.016|||||||Mixed Models Analysis|||||||0.016
71104825|NCT01690273|141716856|SUPERIORITY_OR_OTHER|||||||0|||||||Mixed Models Analysis|||||||0.000
71104826|NCT01690273|141716856|SUPERIORITY_OR_OTHER|||||||0.889|||||||Mixed Models Analysis|||||||0.889
71104827|NCT01690273|141716856|SUPERIORITY_OR_OTHER|||||||0.098|||||||Mixed Models Analysis|||||||0.098
71104828|NCT01690273|141716856|SUPERIORITY_OR_OTHER|||||||0.645|||||||Mixed Models Analysis|||||||0.645
71104829|NCT01690273|141716857|SUPERIORITY_OR_OTHER|||||||0.07|||||||Mixed Models Analysis|||||||0.07
71104830|NCT01690273|141716857|SUPERIORITY_OR_OTHER|||||||0.13|||||||Mixed Models Analysis|||||||0.13
71104831|NCT01690273|141716857|SUPERIORITY_OR_OTHER|||||||0.97|||||||Mixed Models Analysis|||||||0.97
71104832|NCT01690273|141716857|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
71104833|NCT01690273|141716857|SUPERIORITY_OR_OTHER|||||||0.338|||||||Mixed Models Analysis|||||||0.338
71104834|NCT01690273|141716857|SUPERIORITY_OR_OTHER|||||||0.476|||||||Mixed Models Analysis|||||||0.476
71104835|NCT01690273|141716858|SUPERIORITY_OR_OTHER|||||||0.88|||||||Mixed Models Analysis|||||||0.88
71104836|NCT01690273|141716858|SUPERIORITY_OR_OTHER|||||||0.99|||||||Mixed Models Analysis|||||||0.99
71104837|NCT01690273|141716858|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
71104838|NCT01690273|141716858|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
71104839|NCT01690273|141716858|SUPERIORITY_OR_OTHER|||||||0.995|||||||Mixed Models Analysis|||||||0.995
71104840|NCT01690273|141716858|SUPERIORITY_OR_OTHER|||||||0.985|||||||Mixed Models Analysis|||||||0.985
71104841|NCT01690273|141716859|SUPERIORITY_OR_OTHER|||||||0.9|||||||Mixed Models Analysis|||||||0.9
71104842|NCT01690273|141716859|SUPERIORITY_OR_OTHER|||||||0.7|||||||Mixed Models Analysis|||||||0.7
71104843|NCT01690273|141716859|SUPERIORITY_OR_OTHER|||||||0.99|||||||Mixed Models Analysis|||||||0.99
71104844|NCT01690273|141716859|SUPERIORITY_OR_OTHER|||||||0.999|||||||Mixed Models Analysis|||||||0.999
71104845|NCT01690273|141716859|SUPERIORITY_OR_OTHER|||||||0.9|||||||Mixed Models Analysis|||||||0.900
71104846|NCT01690273|141716859|SUPERIORITY_OR_OTHER|||||||0.739|||||||Mixed Models Analysis|||||||0.739
71104847|NCT01690273|141716860|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
71104848|NCT01690273|141716860|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
71104849|NCT01690273|141716860|SUPERIORITY_OR_OTHER|||||||0.37|||||||Mixed Models Analysis|||||||0.37
71104850|NCT01690273|141716860|SUPERIORITY_OR_OTHER|||||||0.618|||||||Mixed Models Analysis|||||||0.618
71104851|NCT01690273|141716860|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
71104852|NCT01690273|141716860|SUPERIORITY_OR_OTHER|||||||0.689|||||||Mixed Models Analysis|||||||0.689
70930389|NCT03279978|141359059|OTHER||Slope|0.5799|STANDARD_ERROR_OF_MEAN|0.0656|||TWO_SIDED|95.0|0.4441|0.7156||||||Dose proportionality for Cmax,ss of BI 730357 in plasma - fed groups was assessed using a power model (regression model applied to log-transformed data).|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.7156|0.4441|
70930390|NCT05525104|141359060|SUPERIORITY|||||||0.041|||||||Wilcoxon (Mann-Whitney)|||||||0.041
70930391|NCT05525104|141359061|SUPERIORITY|||||||0.066|||||||Wilcoxon (Mann-Whitney)|||||||0.066
70930392|NCT05525104|141359065|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
71016145|NCT03930615|141540419|SUPERIORITY||Treatment difference|-14.1||||0.0012|TWO_SIDED|95.0|-23.3|-5.0|||Mantel Haenszel|Stratum adjusted|Letermovir minus placebo||95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|-5.0|-23.3|0.0012
71016146|NCT03930615|141540420|SUPERIORITY||Treatment Difference|-5.7||||0.1494|TWO_SIDED|95.0|-16.5|5.1|||Mantel Haenszel|Stratum adjusted|Letermovir minus placebo||95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|5.1|-16.5|0.1494
71016147|NCT03930615|141540421|SUPERIORITY||Treatment difference|0.7||||0.6244|TWO_SIDED|95.0|-3.8|5.3|||Mantel Haenszel|Stratum adjusted|Letermovir minus placebo||95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|5.3|-3.8|0.6244
71016148|NCT03930615|141540422|SUPERIORITY||Treatment Difference|0.3||||0.5264|TWO_SIDED|95.0|-7.9|8.4|||Mantel Haenszel|Stratum adjusted|Letermovir minus placebo||95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|8.4|-7.9|0.5264
71016149|NCT01281475|141540430|SUPERIORITY|We modeled each outcome variable as a function of treatment (ie, levodopa versus placebo), visit (ie, baseline vs. 12-month follow-up) and the treatment-by-visit interaction; the interaction term tests whether the effect of levodopa treatment over time is significantly greater than that of the placebo group.||||||0.75||||||This was the calculated p value without correction for multiple comparisons|Generalized estimating equations|||We performed generalized estimating equations with an unstructured covariance matrix to account for inter-correlations within measurements on the same participant over time.||||0.75
71016150|NCT02080273|141540432|OTHER|||||||0.919|||||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.919
71016151|NCT02080273|141540433|SUPERIORITY_OR_OTHER|||||||0.001||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.||||0.001
71016152|NCT02080273|141540434|SUPERIORITY_OR_OTHER|||||||0.001||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.||||0.001
71016153|NCT02080273|141540435|OTHER|||||||0.001||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.||||0.001
71016154|NCT02080273|141540436|OTHER|||||||0.922|||||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.922
71016155|NCT02080273|141540437|OTHER|||||||0.848||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline||||0.848
70930393|NCT03636490|141359072|OTHER|We tested an association between change in urinary sodium excretion rate with stress and ratio of awake-to-asleep urinary sodium excretion rate.|unstandardized B coefficients|0.0021||||0.0032||95.0|0.0007|0.0034|||Regression, Linear|Adjusted for age, sex, race, ethnicity, body mass index, mean DBP during the baseline period, and 24-hour creatinine clearance.||||0.0034|0.0007|0.0032
71016156|NCT02080273|141540438|OTHER|||||||0.001||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.||||0.001
70930394|NCT03636490|141359073|OTHER|We tested an association between ratio of awake-to-asleep urinary sodium excretion rate and SBP dipping.|unstandardized B coefficients|0.8244||||0.037||95.0|0.0487|1.6|||Regression, Linear|Adjusted for age, sex, race, ethnicity, BMI, smoking, alcohol use, glucose, 24-hr sodium and potassium excretion, 24-hr creat clear, and FENa|Data are unstandardized B coefficients (95% CI)|||1.6000|0.0487|0.037
71016157|NCT02080273|141540439|OTHER|||||||0.001||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.||||0.001
71016158|NCT02262507|141540467|OTHER||||||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
71016159|NCT00741026|141540468|SUPERIORITY_OR_OTHER|||||||0.0203|||||||Wilcoxon Signed-rank|||||||0.0203
71016160|NCT00741026|141540469|SUPERIORITY_OR_OTHER|||||||0.0105|||||||Wilcoxon Sign-rank|||||||0.0105
71016161|NCT00741026|141540470|SUPERIORITY_OR_OTHER|||||||0.0166|||||||Wilcoxon Sign-rank|||||||0.0166
71016162|NCT00741026|141540471|SUPERIORITY_OR_OTHER|||||||0.0184|||||||Wilcoxon Sign-rank|||||||0.0184
71016163|NCT00741026|141540472|SUPERIORITY_OR_OTHER|||||||0.017|||||||Wilcoxon Sign-rank|||||||0.0170
71016164|NCT02712359|141540495|NON_INFERIORITY|The lower limit of the 2-sided 95% confidence interval (CI) for the difference (Havrix 1 dose\_Year 8 Group minus Havrix 2 doses\_Year 8 Group) of percentage of subjects with anti-HAV antibody concentrations ≥ 15 mIU/mL was to be greater than or equal to the pre-defined clinical non-inferiority limit of -10%.|Difference in seropositivity rate|-23.33|||<|0.0001|TWO_SIDED|95.0|-28.78|-18.29|||Fisher Exact|||Difference in seropositivity rates for anti-HAV antibody: To demonstrate that 1-dose schedule of Havrix (Havrix 1 dose\_Year 8 Group) was non-inferior to the 2-dose schedule of Havrix (Havrix 2 doses\_Year 8 Group), in terms of seropositivity rates for anti-HAV antibody, measured by ELISA, approximately 8 years after the administration of the last vaccine dose.||-18.29|-28.78|<0.0001
70930395|NCT03498521|141359128|SUPERIORITY||Stratified Cox proportional hazard|0.72||||0.0079|TWO_SIDED|95.0|0.56|0.92|||Stratified log-rank|||||0.92|0.56|0.0079
71029479|NCT00113425|141566785|SUPERIORITY_OR_OTHER|||||||0.49|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in cysts for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.49
71029480|NCT00113425|141566786|SUPERIORITY_OR_OTHER|||||||0.21|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in closed comedones for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.21
71104853|NCT01690273|141716861|SUPERIORITY_OR_OTHER|||||||0.8|||||||Mixed Models Analysis|||||||0.8
71104854|NCT01690273|141716861|SUPERIORITY_OR_OTHER|||||||0.97|||||||Mixed Models Analysis|||||||0.97
71104855|NCT01690273|141716861|SUPERIORITY_OR_OTHER|||||||0.99|||||||Mixed Models Analysis|||||||0.99
71104856|NCT01690273|141716861|SUPERIORITY_OR_OTHER|||||||0.999|||||||Mixed Models Analysis|||||||0.999
71104857|NCT01690273|141716861|SUPERIORITY_OR_OTHER|||||||0.929|||||||Mixed Models Analysis|||||||0.929
71104858|NCT01690273|141716861|SUPERIORITY_OR_OTHER|||||||0.98|||||||Mixed Models Analysis|||||||0.980
71104859|NCT01690273|141716862|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
71104860|NCT01690273|141716862|SUPERIORITY_OR_OTHER|||||||0|||||||Mixed Models Analysis|||||||0.000
71104861|NCT01690273|141716862|SUPERIORITY_OR_OTHER|||||||0.35|||||||Mixed Models Analysis|||||||0.350
71104862|NCT01690273|141716862|SUPERIORITY_OR_OTHER|||||||0.997|||||||Mixed Models Analysis|||||||0.997
71104863|NCT01690273|141716862|SUPERIORITY_OR_OTHER|||||||0.97|||||||Mixed Models Analysis|||||||0.970
71104864|NCT01690273|141716862|SUPERIORITY_OR_OTHER|||||||0.999|||||||Mixed Models Analysis|||||||0.999
71104865|NCT01690273|141716863|SUPERIORITY_OR_OTHER|||||||0.997|||||||Mixed Models Analysis|||||||0.997
71104866|NCT01690273|141716863|SUPERIORITY_OR_OTHER|||||||0|||||||Mixed Models Analysis|||||||0.000
71104867|NCT01690273|141716863|SUPERIORITY_OR_OTHER|||||||0.503|||||||Mixed Models Analysis|||||||0.503
71104868|NCT01690273|141716863|SUPERIORITY_OR_OTHER|||||||0.814|||||||Mixed Models Analysis|||||||0.814
71104869|NCT01690273|141716863|SUPERIORITY_OR_OTHER|||||||0.643|||||||Mixed Models Analysis|||||||0.643
71104870|NCT01690273|141716863|SUPERIORITY_OR_OTHER|||||||0.999|||||||Mixed Models Analysis|||||||0.999
71104871|NCT01690273|141716864|SUPERIORITY_OR_OTHER|||||||0.787|||||||Mixed Models Analysis|||||||0.787
71104872|NCT01690273|141716864|SUPERIORITY_OR_OTHER|||||||0.408|||||||Mixed Models Analysis|||||||0.408
71104873|NCT01690273|141716864|SUPERIORITY_OR_OTHER|||||||0.157|||||||Mixed Models Analysis|||||||0.157
71104874|NCT01690273|141716864|SUPERIORITY_OR_OTHER|||||||0.835|||||||Mixed Models Analysis|||||||0.835
71104875|NCT01690273|141716864|SUPERIORITY_OR_OTHER|||||||0.256|||||||Mixed Models Analysis|||||||0.256
71104876|NCT01690273|141716864|SUPERIORITY_OR_OTHER|||||||0.935|||||||Mixed Models Analysis|||||||0.935
71104877|NCT01690273|141716865|SUPERIORITY_OR_OTHER|||||||0.978|||||||Mixed Models Analysis|||||||0.978
71104878|NCT01690273|141716865|SUPERIORITY_OR_OTHER|||||||0.169|||||||Mixed Models Analysis|||||||0.169
71104879|NCT01690273|141716865|SUPERIORITY_OR_OTHER|||||||0.002|||||||Mixed Models Analysis|||||||0.002
71104880|NCT01690273|141716865|SUPERIORITY_OR_OTHER|||||||0.993|||||||Mixed Models Analysis|||||||0.993
71104881|NCT01690273|141716865|SUPERIORITY_OR_OTHER|||||||0.105|||||||Mixed Models Analysis|||||||0.105
71104882|NCT01690273|141716865|SUPERIORITY_OR_OTHER|||||||0.335|||||||Mixed Models Analysis|||||||0.335
71104883|NCT00895921|141716906|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.242|STANDARD_ERROR_OF_MEAN|0.1139||0.042|TWO_SIDED|95.0|0.00943|0.47605||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||.47605|.00943|0.042
71104884|NCT00895921|141716907|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.253|STANDARD_ERROR_OF_MEAN|0.224||0.269|TWO_SIDED|95.0|-0.208|0.714||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||||0.714|-0.208|0.269
71104885|NCT00895921|141716908|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.149||0.012|TWO_SIDED|95.0|0.095|0.705|||Chi-squared, Corrected|||Comparison of akathisia rates between the two arms.||.705|.095|0.012
71104886|NCT00583219|141716922|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline at one month||||0.004
71104887|NCT00583219|141716922|SUPERIORITY_OR_OTHER|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months||||0.81
71104888|NCT00583219|141716923|SUPERIORITY_OR_OTHER|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 1 month||||0.21
71104889|NCT00583219|141716923|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months||||0.43
71104890|NCT00583219|141716925|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline||||0.005
71104891|NCT00583219|141716926|SUPERIORITY_OR_OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline||||0.22
71104892|NCT00583219|141716927|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 1 month||||0.24
71104893|NCT00583219|141716927|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months||||0.14
71104894|NCT00583219|141716928|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 1 month||||0.24
71104895|NCT00583219|141716928|SUPERIORITY_OR_OTHER|||||||0.033|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months||||0.033
71016165|NCT02712359|141540496|NON_INFERIORITY|The lower limit of the 2-sided 95% confidence interval (CI) for the difference (Havrix 1 dose\_Year 10 Group minus Havrix 2 doses\_Year 10 Group) of percentage of subjects with anti-HAV antibody concentrations ≥ 15 mIU/mL was to be greater than or equal to the pre-defined clinical non-inferiority limit of -10%.|Difference in seropositivity rate|-24.43|||<|0.0001|TWO_SIDED|95.0|-30.11|-19.03|||Fisher Exact|||Difference in seropositivity rates for anti-HAV antibody: To demonstrate that 1-dose schedule of Havrix (Havrix 1 dose\_Year 10 Group) was non-inferior to the 2-dose schedule of Havrix (Havrix 2 doses\_Year 10 Group), in terms of seropositivity rates for anti-HAV antibody, measured by ELISA, approximately 10 years after the administration of the last vaccine dose.||-19.03|-30.11|<0.0001
71016166|NCT02411110|141540520|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.34||||0.505|||||||ANCOVA|Baseline value as a covariate; treatment group and stratification (age: \< 40 or ≥ 40 years and baseline bladder pain NRS: ≤ 6 or \> 6) as factors.|LiRIS® - Placebo|||||0.505
71016167|NCT03292731|141540521|OTHER||Odds Ratio (OR)|1.0||||0.96|TWO_SIDED|95.0|0.93|1.08||adjusted for cerclage|Regression, Logistic|adjusted for cerclage||logistic regression comparing drug concentration to the rate of sPTB||1.08|0.93|0.96
71016168|NCT03292731|141540522|OTHER||Slope|1.11||||0.05|TWO_SIDED|95.0|0.0|2.23|||Regression, Linear|||||2.23|0.00|0.05
71016169|NCT03292731|141540523|OTHER||Slope|1.56||||0.022|TWO_SIDED|95.0|0.25|2.87|||Regression, Linear|||||2.87|0.25|0.022
71016170|NCT03292731|141540524|SUPERIORITY|||||||0.82||||||no adjustments|Fisher Exact|||Only RCT subjects utilized in neonatal safety analysis||||0.82
71016171|NCT03901352|141540533|SUPERIORITY||Difference of LSM vs placebo|-0.71|STANDARD_ERROR_OF_MEAN|0.187||0.0001|TWO_SIDED|95.0|-1.08|-0.34|||ANCOVA||"The multiple imputation (MI) was based on a nonfuture dependence model using the pattern mixture model (PMM) approach with shifting parameters under the missing not at random (MNAR0 mechanism for the missing weekly ADPS."|||-0.34|-1.08|0.0001
71016172|NCT02871921|141540550|EQUIVALENCE|A linear regression model was run with the outcome being the MoCA score at Month 6, controlling for the baseline MoCA score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score.|Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.86||0.87|TWO_SIDED||||||Regression, Linear|||Outcome: MoCA at Month 6 Among participants with normal cognition||||0.87
71016173|NCT02871921|141540550|EQUIVALENCE|A linear regression model was run with the outcome being the MoCA score at Month 6, controlling for the baseline MoCA score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score.|Mean Difference (Final Values)|1.75|STANDARD_ERROR_OF_MEAN|0.76||0.03|TWO_SIDED||||||Regression, Linear|||Outcome: MoCA at Month 6 Among MCI||||.03
71016174|NCT02871921|141540551|EQUIVALENCE|A linear regression model was run with the outcome being the Category Fluency test score at Month 6, controlling for tits baseline score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score and a COVID-19 pandemic period indicator (0: pre-COVID-19 pandemic, 1: during COVID-19 pandemic period).|Mean Difference (Final Values)|2.56|STANDARD_ERROR_OF_MEAN|1.19||0.03|TWO_SIDED||||||Regression, Linear|||Outcome: Category fluency animals Among participants with normal cognition||||0.03
71016175|NCT02871921|141540551|OTHER|A linear regression model was run with the outcome being the Category Fluency test score at Month 6, controlling for tits baseline score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score and a COVID-19 pandemic period indicator (0: pre-COVID-19 pandemic, 1: during COVID-19 pandemic period).|Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.93||0.46|TWO_SIDED||||||Regression, Linear|||Outcome: Category Fluency (Animals) at Month 6 Among MCI participants||||0.46
71029481|NCT00113425|141566787|SUPERIORITY_OR_OTHER|||||||0.27|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in open comedones for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.27
71104896|NCT00583219|141716929|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Exact binomial sign test|||P value change from baseline to 1 month||||>0.99
71104897|NCT00583219|141716929|SUPERIORITY_OR_OTHER|||||||0.25|||||||exact binomial sign test|||P value change from baseline to 3 months||||0.25
71104898|NCT00583219|141716931|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to one month||||<0.001
71104899|NCT00583219|141716932|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline||||0.004
71104900|NCT00583219|141716933|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 1 month||||0.003
71104901|NCT00583219|141716933|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months.||||0.001
71029482|NCT00113425|141566788|SUPERIORITY_OR_OTHER|||||||0.04|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in erythematous macules for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.04
71104902|NCT00583219|141716934|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to one month||||0.001
71104903|NCT00583219|141716934|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months||||<0.001
71104904|NCT00583219|141716935|SUPERIORITY_OR_OTHER|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 1 month.||||0.007
71104905|NCT00583219|141716935|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months||||0.002
70850694|NCT04518995|141189573|SUPERIORITY||||||<|0.0001||||||P-value was calculated by cochran mantel haenszel (CMH) test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||<0.0001
71016176|NCT02871921|141540552|EQUIVALENCE|A linear regression model was run with the outcome being the Craft Stroy Immediate Recall score at Month 6, controlling for its baseline score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score and a COVID-19 pandemic period indicator (0: pre-COVID-19 pandemic, 1: during COVID-19 pandemic period).|Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.82||0.45|TWO_SIDED||||||Regression, Linear|||Outcome: Craft Stroy Immediate Recall (paraphrase scoring) Among participants with normal cognition||||0.45
71029483|NCT00113425|141566789|SUPERIORITY_OR_OTHER|||||||0.01|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in acne severity for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.01
71104906|NCT00619866|141716961|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.25||0.2311|TWO_SIDED|95.0|-0.81|0.2|||Repeated Measures Analysis of Covariance||Difference = Elagolix - Placebo|Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.20|-0.81|0.2311
71104907|NCT00619866|141716961|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.25||0.1521|TWO_SIDED|95.0|-0.86|0.14|||Repeated Measures Analysis of Covariance||Difference = Elagolix - Placebo|Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.14|-0.86|0.1521
70850695|NCT04518995|141189573|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||<0.0001
71029484|NCT02003183|141566793|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_DEVIATION|0.1|<|0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This analysis applies to the Amygdala.||||<0.02
71029485|NCT02480764|141566917|NON_INFERIORITY|A test for noninferiority was done using a margin of 1.5 mm Hg. A test for significant difference was performed at 5% level.|Least Square Mean Difference|-1.932|STANDARD_ERROR_OF_MEAN|1.4512||0.184|TWO_SIDED|95.0|-4.782|0.918||Change at Week 8: P-value was calculated using analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and baseline trough sitting clinic SBP as a continuous covariate.|ANCOVA|||||0.918|-4.782|0.184
71029486|NCT02480764|141566917|NON_INFERIORITY|A test for noninferiority was done using a margin of 1.5 mm Hg. A test for significant difference was performed at 5% level.|Least Square Mean Difference|-3.685|STANDARD_ERROR_OF_MEAN|1.4344||0.01|TWO_SIDED|95.0|-6.502|-0.868||Change at Week 8: P-value was calculated using ANCOVA model, with treatment group as a fixed effect and baseline trough sitting clinic SBP as a continuous covariate.|ANCOVA|||||-0.868|-6.502|0.010
71029487|NCT02480764|141566918|OTHER||Least Square Mean Difference|-1.459|STANDARD_ERROR_OF_MEAN|0.9455||0.123|TWO_SIDED|95.0|-3.316|0.397||Change at Week 8: P-value was calculated using ANCOVA model, with treatment group as a fixed effect and baseline trough sitting clinic DBP as a continuous covariate.|ANCOVA|||||0.397|-3.316|0.123
71029488|NCT02480764|141566918|OTHER||Least Square Mean Difference|-2.822|STANDARD_ERROR_OF_MEAN|0.9354||0.003|TWO_SIDED|95.0|-4.659|-0.985||Change at 8 Week: P-value was calculated using ANCOVA model, with treatment group as a fixed effect and baseline trough sitting clinic DBP as a continuous covariate.|ANCOVA|||||-0.985|-4.659|0.003
71029489|NCT02480764|141566919|OTHER||Odds Ratio (OR)|0.877|STANDARD_ERROR_OF_MEAN|0.192||0.548|TWO_SIDED|95.0|0.571|1.347||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.347|0.571|0.548
71029490|NCT02480764|141566919|OTHER||Odds Ratio (OR)|0.979|STANDARD_ERROR_OF_MEAN|0.2136||0.921|TWO_SIDED|95.0|0.638|1.501||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.501|0.638|0.921
71029491|NCT02480764|141566920|OTHER||Odds Ratio (OR)|1.033|STANDARD_ERROR_OF_MEAN|0.2805||0.904|TWO_SIDED|95.0|0.607|1.759||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic|||||1.759|0.607|0.904
71029492|NCT02480764|141566920|OTHER||Odds Ratio (OR)|1.074|STANDARD_ERROR_OF_MEAN|0.2897||0.79|TWO_SIDED|95.0|0.633|1.823||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic|||||1.823|0.633|0.790
71029493|NCT02480764|141566921|OTHER||Odds Ratio (OR)|0.901|STANDARD_ERROR_OF_MEAN|0.1916||0.624|TWO_SIDED|95.0|0.594|1.367||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.367|0.594|0.624
71029494|NCT02480764|141566921|OTHER||Odds Ratio (OR)|1.103|STANDARD_ERROR_OF_MEAN|0.235||0.647|TWO_SIDED|95.0|0.726|1.674||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.674|0.726|0.647
71029495|NCT02480764|141566922|OTHER||Odds Ratio (OR)|0.831|STANDARD_ERROR_OF_MEAN|0.1846||0.404|TWO_SIDED|95.0|0.537|1.284||Clinic SBP \<140 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.284|0.537|0.404
71029496|NCT02480764|141566922|OTHER||Odds Ratio (OR)|0.937|STANDARD_ERROR_OF_MEAN|0.2078||0.768|TWO_SIDED|95.0|0.606|1.447||Clinic SBP \<140 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.447|0.606|0.768
71029497|NCT02480764|141566922|OTHER||Odds Ratio (OR)|1.051|STANDARD_ERROR_OF_MEAN|0.2837||0.852|TWO_SIDED|95.0|0.62|1.784||Clinic DBP \<90 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic|||||1.784|0.620|0.852
71016177|NCT02871921|141540552|EQUIVALENCE|A linear regression model was run with the outcome being the Craft Story score at Month 6, controlling for tits baseline score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score and a COVID-19 pandemic period indicator (0: pre-COVID-19 pandemic, 1: during COVID-19 pandemic period).|Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.8||0.41|TWO_SIDED||||||Regression, Linear|||Outcome: Craft Story Immediate Recall (paraphrase) Among MCI||||0.41
70850696|NCT04518995|141189573|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||<0.0001
71016178|NCT02871921|141540553|EQUIVALENCE|A linear regression model was run with the outcome being the Craft Story test score at Month 6, controlling for tits baseline score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score and a COVID-19 pandemic period indicator (0: pre-COVID-19 pandemic, 1: during COVID-19 pandemic period).|Median Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.77||0.74|TWO_SIDED||||||Regression, Linear|||Outcome: Craft Story Delayed Recall) (Paraphrase scoring) Among participants with normal cognition||||0.74
71016179|NCT02871921|141540553|EQUIVALENCE|A linear regression model was run with the outcome being the Craft Story test score at Month 6, controlling for tits baseline score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score and a COVID-19 pandemic period indicator (0: pre-COVID-19 pandemic, 1: during COVID-19 pandemic period).|Median Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.79||0.9|TWO_SIDED||||||Regression, Linear|||Outcome: Craft Story Delayed Recall (Paraphrase scoring) Among MCI||||0.90
71016180|NCT03226366|141540555|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.29|TWO_SIDED|95.0|-20.4|6.1|||Regression, Linear||Change in emergency department door-to-antibiotic time (minutes) based on adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable regression to estimate the change in emergency department (ED) door-to-antibiotic time after versus before intervention implementation at the intervention site adjusted for the change observed over the same time period at the control sites and for subject's age, sex, Elixhauser Comorbidity Score, initial systolic blood pressure, initial Glasgow Coma Scale score \<14. initial temperature, ED triage acuity score, and ED arrival via ambulance.||6.1|-20.4|0.29
71016181|NCT03226366|141540556|SUPERIORITY||Odds Ratio (OR)|0.81||||0.72|TWO_SIDED|95.0|0.25|2.61|||Regression, Logistic||Odds ratio for hospital mortality after versus before intervention implementation based on adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable regression to estimate the change in odds of hospital mortality after versus before implementation at the intervention site with adjustment for observed change in outcome over the same time period at the control sites as well as for subject's age, sex, Elixhauser Comorbidity Score, initial systolic blood pressure, an initial Glasgow Coma Scale score \<14. initial temperature, ED triage acuity score, and arrival to the ED via ambulance.||2.61|0.25|0.72
71016182|NCT03226366|141540557|SUPERIORITY||Mean Difference (Final Values)|-9.5||||0.26|TWO_SIDED|95.0|-25.9|7.0|||Regression, Linear||Change in emergency department length of stay (minutes) after versus before intervention implementation based on adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable regression to estimate the change in emergency department length of stay after versus before implementation at the intervention site with adjustment for the change observed over the same time period at the control sites as well as for subject's age, sex, Elixhauser Comorbidity Score, initial systolic blood pressure, an initial Glasgow Coma Scale score \<14. initial temperature, ED triage acuity score, and arrival to the ED via ambulance.||7.0|-25.9|0.26
71016183|NCT03226366|141540558|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.55|TWO_SIDED|95.0|-3.3|1.8|||Regression, Linear||Estimated change in emergency department door-to-physician evaluation time (minutes) after versus before intervention implementation based on adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable regression to estimate the change in emergency department (ED) door-to-physician evaluation time after versus before implementation at the intervention site adjusted for the change observed over the same time period at the control sites and for subject's age, sex, Elixhauser Comorbidity Score, initial systolic blood pressure, initial Glasgow Coma Scale score \<14. initial temperature, ED triage acuity score, and ED arrival via ambulance.||1.8|-3.3|0.55
71016184|NCT02596009|141540563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.97|||<|0.0001|TWO_SIDED|95.0|23.7|30.24|||paired t-test|||||30.24|23.70|<0.0001
71016185|NCT02596009|141540563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.93|||<|0.0001|TWO_SIDED|95.0|49.15|58.72|||paired t-test|||||58.72|49.15|<0.0001
71050019|NCT02504671|141606197|OTHER||Mean Difference (Net)|3.21||||0.154|TWO_SIDED|95.0|-1.22|7.64||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Mental Health|||7.64|-1.22|0.154
71050020|NCT02504671|141606197|OTHER||Mean Difference (Net)|2.5||||0.262|TWO_SIDED|95.0|-1.88|6.89||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Mental Health|||6.89|-1.88|0.262
71050021|NCT02504671|141606197|OTHER||Mean Difference (Net)|1.32||||0.693|TWO_SIDED|95.0|-5.28|7.93||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Mental Health|||7.93|-5.28|0.693
71050022|NCT02504671|141606197|OTHER||Mean Difference (Net)|3.28||||0.302|TWO_SIDED|95.0|-2.98|9.54||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Mental Health|||9.54|-2.98|0.302
71050023|NCT02504671|141606197|OTHER||Mean Difference (Net)|0.61||||0.844|TWO_SIDED|95.0|-5.54|6.77||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Mental Health|||6.77|-5.54|0.844
71016186|NCT04611152|141540592|NON_INFERIORITY|The maximum clinically acceptable true difference between KSI-301 and aflibercept participants to be considered non-inferior is 4.5 ETDRS letters, i.e. the non-inferiority margin|Adjusted mean difference|-3.8|STANDARD_ERROR_OF_MEAN|0.84||0.4162|TWO_SIDED|95.04|-5.47|-2.17|||Mixed Models Analysis|MMRM model with treatment, visit, treatment by visit interaction, randomization stratification factors, and continuous baseline BCVA and OCT CST.||||-2.17|-5.47|0.4162
71016187|NCT04611152|141540593|NON_INFERIORITY|"The maximum clinically acceptable non-inferiority margin between KSI-301 and aflibercept subjects is 10% to be considered non-inferior, i.e. the non-inferiority margin is 10%"|Difference of weighted percentages|0.6|||<|0.0001|TWO_SIDED|95.04|-0.7|2.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by study identifier and randomization stratification variables.|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||2|-0.7|<0.0001
71016188|NCT04611152|141540594|NON_INFERIORITY|"The maximum clinically acceptable non-inferiority margin between KSI-301 and aflibercept subjects is 10% to be considered non-inferior, i.e. the non-inferiority margin is 10%"|Difference of weighted percentages|0.0|||||TWO_SIDED|95.04|0.0|0.0|||||Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||0|0|
71016189|NCT00956813|141540610|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||||||0.29
71104908|NCT00619866|141716962|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.24||0.2041|TWO_SIDED|95.0|-0.77|0.17|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.17|-0.77|0.2041
71104909|NCT00619866|141716962|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.24||0.3375|TWO_SIDED|95.0|-0.69|0.24|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.24|-0.69|0.3375
71104910|NCT00619866|141716962|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.25||0.0354|TWO_SIDED|95.0|-1.01|-0.04|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.04|-1.01|0.0354
71104911|NCT00619866|141716962|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.25||0.3618|TWO_SIDED|95.0|-0.71|0.26|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.26|-0.71|0.3618
71104912|NCT00619866|141716963|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.46||0.799|TWO_SIDED|95.0|-1.01|0.78|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.78|-1.01|0.7990
71104913|NCT00619866|141716963|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.46||0.5042|TWO_SIDED|95.0|-1.21|0.59|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.59|-1.21|0.5042
71104914|NCT00619866|141716963|SUPERIORITY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.48||0.1459|TWO_SIDED|95.0|-1.63|0.24|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.24|-1.63|0.1459
71104915|NCT00619866|141716963|SUPERIORITY||LS Mean Difference|-1.16|STANDARD_ERROR_OF_MEAN|0.48||0.0163|TWO_SIDED|95.0|-2.1|-0.21|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.21|-2.10|0.0163
71016190|NCT00956813|141540612|SUPERIORITY_OR_OTHER|||||||0.93|||||||Kruskal-Wallis|||||||0.93
71016191|NCT00956813|141540613|SUPERIORITY_OR_OTHER|||||||0.19|||||||Kruskal-Wallis|||Testing the change in score from baseline to treatment completion for vasomotor-related questions in the MENQOL form.||||0.19
71016192|NCT00956813|141540613|SUPERIORITY_OR_OTHER|||||||0.78|||||||Kruskal-Wallis|||Testing the change in score from baseline to treatment completion for Psychosocial-related questions in the MENQOL form.||||0.78
71016193|NCT00956813|141540613|SUPERIORITY_OR_OTHER|||||||0.238|||||||Kruskal-Wallis|||Testing the change in score from baseline to treatment completion for Physical-related questions in the MENQOL form.||||0.238
70930396|NCT02163694|141359150|SUPERIORITY|||||||0.003|||||||Log-rank test|||PFS was compared between the treatment groups using the log-rank test, stratified by prior platinum therapy (Yes versus No) and receptor status (estrogen receptor \[ER\] and/or progesterone receptor \[PgR\] positive versus ER/PgR negative).||||0.003
70930397|NCT02163694|141359150|SUPERIORITY||Stratified Cox proportional hazards|0.728||||0.003|TWO_SIDED|95.0|0.59|0.9|||Stratified Cox proportional hazards|||A Cox proportional hazards model, stratified by prior platinum therapy (Yes versus No) and receptor status (estrogen receptor (ER) and/or progesterone receptor (PgR) positive versus ER/PgR negative) was used to estimate the hazard ratio and 95% confidence interval comparing the two treatment arms.||0.900|0.590|0.003
71016194|NCT00956813|141540613|SUPERIORITY_OR_OTHER|||||||0.497|||||||Kruskal-Wallis|||Testing the change in score from baseline to treatment completion for Sexually-related questions in the MENQOL form.||||0.497
70850697|NCT04518995|141189573|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||<0.0001
70930398|NCT02163694|141359151|SUPERIORITY|||||||0.41|||||||Log Rank|||||||0.410
71016195|NCT00956813|141540614|SUPERIORITY_OR_OTHER|||||||0.089|||||||Kruskal-Wallis|||||||0.089
71016196|NCT01275170|141540630|OTHER|Geometric mean ratio (GMR) \[Renal Impairment/Healthy Control\]|GMR|1.63|||||TWO_SIDED|90.0|1.12|2.39||||||||2.39|1.12|
71016197|NCT01275170|141540630|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.19|||||TWO_SIDED|90.0|1.51|3.18||||||||3.18|1.51|
71016198|NCT01275170|141540630|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|4.87|||||TWO_SIDED|90.0|3.37|7.04||||||||7.04|3.37|
71016199|NCT01275170|141540630|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|9.32|||||TWO_SIDED|90.0|6.45|13.46||||||||13.46|6.45|
71016200|NCT01275170|141540630|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.76|||||TWO_SIDED|90.0|1.2|2.58||||||||2.58|1.20|
71016201|NCT01275170|141540631|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.1|||||TWO_SIDED|90.0|0.64|1.88||||||||1.88|0.64|
71016202|NCT01275170|141540631|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.04|||||TWO_SIDED|90.0|0.62|1.77||||||||1.77|0.62|
71016203|NCT01275170|141540631|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.3|||||TWO_SIDED|90.0|0.77|2.2||||||||2.20|0.77|
70930399|NCT02163694|141359151|SUPERIORITY||Stratified Cox proportional hazards|0.914||||0.41|TWO_SIDED|95.0|0.737|1.333|||Stratified Cox proportional hazards|||A Cox proportional hazards model, stratified by prior platinum therapy (Yes versus No) and receptor status (estrogen receptor (ER) and/or progesterone receptor (PgR) positive versus ER/PgR negative) was used to estimate the hazard ratio and 95% confidence interval comparing the two treatment arms.||1.333|0.737|0.410
70930400|NCT02163694|141359152|SUPERIORITY|||||||0.202||||||Nominal P value is from Cochran-Mantel-Haenszel test stratified by ER/PgR status and prior platinum therapy use.|Cochran-Mantel-Haenszel|||||||0.202
70930401|NCT02163694|141359153|SUPERIORITY|||||||0.715||||||Nominal P value is from Cochran-Mantel-Haenszel test stratified by ER/PgR status and prior platinum therapy use.|Cochran-Mantel-Haenszel|||||||0.715
70930402|NCT02163694|141359154|SUPERIORITY|||||||0.004|||||||Log Rank|||||||0.004
71016204|NCT01275170|141540631|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.34|||||TWO_SIDED|90.0|1.39|3.96||||||||3.96|1.39|
71016205|NCT01275170|141540631|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.85|||||TWO_SIDED|90.0|0.5|1.44||||||||1.44|0.50|
71050024|NCT02504671|141606197|OTHER||Mean Difference (Net)|0.66||||0.698|TWO_SIDED|95.0|-2.71|4.04||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Physical Functioning|||4.04|-2.71|0.698
71050025|NCT02504671|141606197|OTHER||Mean Difference (Net)|2.38||||0.159|TWO_SIDED|95.0|-0.94|5.7||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Physical Functioning|||5.70|-0.94|0.159
70850698|NCT04518995|141189573|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||<0.0001
70930403|NCT02163694|141359154|SUPERIORITY||Stratified Cox proportional hazards|0.737||||0.004|TWO_SIDED|95.0|0.597|0.908|||Stratified Cox proportional hazards|Stratified by prior platinum therapy (yes vs no) and receptor status (ER and/or PgR positive vs ER/PgR negative).||||0.908|0.597|0.004
70930404|NCT05061017|141359160|SUPERIORITY|||||||1|TWO_SIDED|95.0|||||Fisher Exact|||||||1.0000
70930405|NCT05061017|141359161|SUPERIORITY|||||||1|TWO_SIDED|95.0|||||Fisher Exact|||||||1.0000
70941539|NCT02762500|141383836|SUPERIORITY||Risk Difference (RD)|-8.1||||0.106|TWO_SIDED|90.0|-18.6|2.5||one-sided p-value|Chi-squared|Statistical test was a one-sided performed at the 5% level of significance. Pearson chi-square test was used to test the null hypothesis.|90% CI obtained based on normal approximation.|The response rate difference is the mean difference in response rates between the treatment and placebo responders. The p-value is based on one-sided Pearson chi-square test.||2.5|-18.6|0.106
71016206|NCT01275170|141540632|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.61|||||TWO_SIDED|90.0|0.42|0.9||||||||0.90|0.42|
71016207|NCT01275170|141540632|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.46|||||TWO_SIDED|90.0|0.31|0.66||||||||0.66|0.31|
71016208|NCT01275170|141540632|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.21|||||TWO_SIDED|90.0|0.14|0.3||||||||0.30|0.14|
71016209|NCT01275170|141540632|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.11|||||TWO_SIDED|90.0|0.07|0.16||||||||0.16|0.07|
71016210|NCT01275170|141540632|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.57|||||TWO_SIDED|90.0|0.39|0.84||||||||0.84|0.39|
71016211|NCT01275170|141540633|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.99|||||TWO_SIDED|90.0|0.82|1.21||||||||1.21|0.82|
71016212|NCT01275170|141540633|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.01|||||TWO_SIDED|90.0|0.84|1.22||||||||1.22|0.84|
71016213|NCT01275170|141540633|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.9|||||TWO_SIDED|90.0|0.74|1.08||||||||1.08|0.74|
71016214|NCT01275170|141540633|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.96|||||TWO_SIDED|90.0|0.79|1.16||||||||1.16|0.79|
71016215|NCT01275170|141540633|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|3.28|||||TWO_SIDED|90.0|2.7|4.0||||||||4.00|2.70|
71016216|NCT01275170|141540636|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.41|||||TWO_SIDED|90.0|1.07|1.84||||||||1.84|1.07|
71016217|NCT01275170|141540636|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.53|||||TWO_SIDED|90.0|1.17|1.99||||||||1.99|1.17|
71016218|NCT01275170|141540636|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.51|||||TWO_SIDED|90.0|1.93|3.26||||||||3.26|1.93|
71016219|NCT01275170|141540636|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|3.1|||||TWO_SIDED|90.0|2.39|4.03||||||||4.03|2.39|
71016220|NCT01275170|141540636|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.99|||||TWO_SIDED|90.0|0.76|1.29||||||||1.29|0.76|
71016221|NCT01275170|141540637|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.15|||||TWO_SIDED|90.0|0.65|2.06||||||||2.06|0.65|
71016222|NCT01275170|141540637|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.07|||||TWO_SIDED|90.0|0.61|1.89||||||||1.89|0.61|
71016223|NCT01275170|141540637|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.32|||||TWO_SIDED|90.0|0.75|2.32||||||||2.32|0.75|
71016224|NCT01275170|141540637|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.46|||||TWO_SIDED|90.0|1.4|4.33||||||||4.33|1.40|
71016225|NCT01275170|141540637|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.86|||||TWO_SIDED|90.0|0.49|1.51||||||||1.51|0.49|
71016226|NCT01275170|141540638|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.71|||||TWO_SIDED|90.0|0.54|0.93||||||||0.93|0.54|
71016227|NCT01275170|141540638|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.65|||||TWO_SIDED|90.0|0.5|0.85||||||||0.85|0.50|
71016228|NCT01275170|141540638|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.4|||||TWO_SIDED|90.0|0.31|0.52||||||||0.52|0.31|
71016229|NCT01275170|141540638|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.32|||||TWO_SIDED|90.0|0.25|0.42||||||||0.42|0.25|
71050026|NCT02504671|141606197|OTHER||Mean Difference (Net)|1.53||||0.36|TWO_SIDED|95.0|-1.76|4.83||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Physical Functioning|||4.83|-1.76|0.360
71016230|NCT01275170|141540638|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.01|||||TWO_SIDED|90.0|0.78|1.31||||||||1.31|0.78|
71016231|NCT01275170|141540639|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.81|||||TWO_SIDED|90.0|0.61|1.08||||||||1.08|0.61|
71016232|NCT01275170|141540639|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.95|||||TWO_SIDED|90.0|0.72|1.26||||||||1.26|0.72|
71016233|NCT01275170|141540639|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.8|||||TWO_SIDED|90.0|0.61|1.06||||||||1.06|0.61|
71050027|NCT02504671|141606197|OTHER||Mean Difference (Net)|2.82||||0.151|TWO_SIDED|95.0|-1.04|6.69||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Physical Functioning|||6.69|-1.04|0.151
71050028|NCT02504671|141606197|OTHER||Mean Difference (Net)|3.01||||0.124|TWO_SIDED|95.0|-0.83|6.86||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Physical Functioning|||6.86|-0.83|0.124
70850699|NCT04518995|141189573|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||<0.0001
70850700|NCT04518995|141189573|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||<0.0001
70850701|NCT04518995|141189573|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||<0.0001
70850702|NCT04518995|141189574|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||<0.0001
70850703|NCT04518995|141189574|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||<0.0001
70850704|NCT04518995|141189574|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||<0.0001
70850705|NCT04518995|141189574|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||<0.0001
71016234|NCT01275170|141540639|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.83|||||TWO_SIDED|90.0|0.63|1.09||||||||1.09|0.63|
71016235|NCT01275170|141540639|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.54|||||TWO_SIDED|90.0|1.93|3.36||||||||3.36|1.93|
71016236|NCT01275170|141540642|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.6|||||TWO_SIDED|90.0|1.03|2.49||||||||2.49|1.03|
71016237|NCT01275170|141540642|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.86|||||TWO_SIDED|90.0|1.21|2.87||||||||2.87|1.21|
71016238|NCT01275170|141540642|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|5.6|||||TWO_SIDED|90.0|3.64|8.59||||||||8.59|3.64|
71016239|NCT01275170|141540642|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|13.75|||||TWO_SIDED|90.0|8.96|21.12||||||||21.12|8.96|
71050029|NCT02504671|141606197|OTHER||Mean Difference (Net)|3.0||||0.12|TWO_SIDED|95.0|-0.79|6.8||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Physical Functioning|||6.80|-0.79|0.120
71016240|NCT01275170|141540642|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|3.64|||||TWO_SIDED|90.0|2.32|5.69||||||||5.69|2.32|
71016241|NCT01275170|141540643|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.25|||||TWO_SIDED|90.0|0.75|2.08||||||||2.08|0.75|
71016242|NCT01275170|141540643|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.13|||||TWO_SIDED|90.0|0.69|1.87||||||||1.87|0.69|
71016243|NCT01275170|141540643|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.49|||||TWO_SIDED|90.0|0.9|2.44||||||||2.44|0.90|
71016244|NCT01275170|141540643|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.49|||||TWO_SIDED|90.0|1.51|4.09||||||||4.09|1.51|
71016245|NCT01275170|141540643|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.94|||||TWO_SIDED|90.0|0.57|1.54||||||||1.54|0.57|
71104916|NCT00619866|141716963|SUPERIORITY||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.5||0.0207|TWO_SIDED|95.0|-2.13|-0.18|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.18|-2.13|0.0207
71104917|NCT00619866|141716963|SUPERIORITY||LS Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|0.5||0.0038|TWO_SIDED|95.0|-2.42|-0.47|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.47|-2.42|0.0038
71104918|NCT00619866|141716964|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.5744|TWO_SIDED|95.0|-0.18|0.1|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.10|-0.18|0.5744
71104919|NCT00619866|141716964|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.728|TWO_SIDED|95.0|-0.17|0.12|||Repeated measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.12|-0.17|0.7280
71104920|NCT00619866|141716964|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.07||0.0195|TWO_SIDED|95.0|-0.32|-0.03|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.03|-0.32|0.0195
71104921|NCT00619866|141716964|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.5589|TWO_SIDED|95.0|-0.19|0.1|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.10|-0.19|0.5589
71104922|NCT00619866|141716964|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.08||0.5558|TWO_SIDED|95.0|-0.2|0.11|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.11|-0.20|0.5558
71016246|NCT01275170|141540644|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.63|||||TWO_SIDED|90.0|0.4|0.97||||||||0.97|0.40|
71104923|NCT00619866|141716964|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.08||0.7121|TWO_SIDED|95.0|-0.18|0.12|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.12|-0.18|0.7121
71104924|NCT00619866|141716965|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.13||0.0286|TWO_SIDED|95.0|-0.54|-0.03|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.03|-0.54|0.0286
71104925|NCT00619866|141716965|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.121|TWO_SIDED|95.0|-0.45|0.05|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.05|-0.45|0.1210
71016247|NCT01275170|141540644|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.54|||||TWO_SIDED|90.0|0.35|0.83||||||||0.83|0.35|
71016248|NCT01275170|141540644|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.18|||||TWO_SIDED|90.0|0.12|0.27||||||||0.27|0.12|
71016249|NCT01275170|141540644|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.07|||||TWO_SIDED|90.0|0.05|0.11||||||||0.11|0.05|
71016250|NCT01275170|141540644|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.27|||||TWO_SIDED|90.0|0.18|0.43||||||||0.43|0.18|
71016251|NCT01275170|141540645|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.8|||||TWO_SIDED|90.0|0.62|1.04||||||||1.04|0.62|
71016252|NCT01275170|141540645|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.91|||||TWO_SIDED|90.0|0.71|1.17||||||||1.17|0.71|
71016253|NCT01275170|141540645|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.8|||||TWO_SIDED|90.0|0.62|1.03||||||||1.03|0.62|
71016254|NCT01275170|141540645|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.76|||||TWO_SIDED|90.0|0.59|0.97||||||||0.97|0.59|
71016255|NCT01275170|141540645|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.81|||||TWO_SIDED|90.0|2.16|3.65||||||||3.65|2.16|
71016256|NCT01275170|141540651|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.52|||||TWO_SIDED|90.0|1.07|2.15||||||||2.15|1.07|
71016257|NCT01275170|141540651|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.63|||||TWO_SIDED|90.0|0.45|0.9||||||||0.90|0.45|
71016258|NCT01275170|141540651|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.67|||||TWO_SIDED|90.0|0.47|0.94||||||||0.94|0.47|
71016259|NCT01275170|141540652|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.07|||||TWO_SIDED|90.0|0.63|1.83||||||||1.83|0.63|
71016260|NCT01275170|141540652|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.6|||||TWO_SIDED|90.0|0.35|1.01||||||||1.01|0.35|
71016261|NCT01275170|141540652|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.61|||||TWO_SIDED|90.0|0.36|1.04||||||||1.04|0.36|
71016262|NCT01275170|141540653|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.47|||||TWO_SIDED|90.0|0.63|3.4||||||||3.40|0.63|
71016263|NCT01275170|141540653|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.91|||||TWO_SIDED|90.0|0.41|2.0||||||||2.00|0.41|
71016264|NCT01275170|141540653|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.81|||||TWO_SIDED|90.0|0.37|1.78||||||||1.78|0.37|
71016265|NCT02864953|141540657|SUPERIORITY||Odds Ratio (OR)|1.17|||=|0.415|TWO_SIDED|95.0|0.8|1.71||P-value was analyzed by ordinal logistic regression adjusting for covariates: region, and IRT stratification factors including rtPA usage (yes/no), thrombectomy usage (yes/no), use of ASPECTS for screening (yes/no), baseline NIHSS (\<=20 vs. \>20).|Regression, Logistic|||||1.71|0.80|=0.4150
71016266|NCT02864953|141540659|SUPERIORITY||Odds Ratio (OR)|1.07|||=|0.7413|TWO_SIDED|95.0|0.72|1.6||A logistic regression model was used to estimate an odds ratio (and 95% CI) of improvement on the mRS dichotomized as 0-4 vs. 5-6 at Day 90.|Regression, Logistic|||||1.60|0.72|=0.7413
71104926|NCT00619866|141716965|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.14||0.0024|TWO_SIDED|95.0|-0.68|-0.15|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.15|-0.68|0.0024
71104927|NCT00619866|141716965|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.14||0.0003|TWO_SIDED|95.0|-0.76|-0.22|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.22|-0.76|0.0003
71016267|NCT02864953|141540660|SUPERIORITY||Mean Difference (Final Values)|0.82|||=|0.1242|TWO_SIDED|95.0|-0.23|1.87||Analysis of Variance (ANOVA) was used to compare the two study arms to assess the treatment effects on midline shift.|ANOVA|||||1.87|-0.23|=0.1242
71016268|NCT03252015|141540709|SUPERIORITY||Mean Difference (Final Values)|-0.182|||||TWO_SIDED|95.0|-0.412|0.049||||||Day 7||0.049|-0.412|
71016269|NCT03252015|141540709|SUPERIORITY||Mean Difference (Final Values)|0.071|||||TWO_SIDED|95.0|-0.081|0.224||||||Day 7||0.224|-0.081|
71016270|NCT03252015|141540709|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Day 21||0.000|0.000|
71016271|NCT03252015|141540709|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Day 21||0.000|0.000|
71016272|NCT03252015|141540710|SUPERIORITY||Mean Difference (Final Values)|-0.145|||||TWO_SIDED|95.0|-0.34|0.05||||||Day 7||0.050|-0.340|
71016273|NCT03252015|141540710|SUPERIORITY||Mean Difference (Final Values)|0.071|||||TWO_SIDED|95.0|-0.081|0.224||||||||0.224|-0.081|
71016274|NCT03252015|141540710|SUPERIORITY||Mean Difference (Final Values)|0.071|||||TWO_SIDED|95.0|-0.151|0.294||||||Day 21||0.294|-0.151|
71016275|NCT03252015|141540710|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Day 21||0.000|0.000|
71016276|NCT00903409|141540755|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The difference between Non-switchers and Switchers in the percent change in non-HDL-C level from the end of the OM6 double-blind study (average of Weeks 6 and 8 for the statistical analysis) to 4 months of OM6X open-label treatment (Month 4).|Kruskal-Wallis|||||||<0.001
71016277|NCT01516684|141540763|OTHER|||||||0.036|||||||T-test and chi-square|||Raw mean total dose administered and raw percentage of times additional propofol was administered will be presented by sedation group treating each event (sedation with lumbar puncture) as the unit. T-test and chi-square tests will be performed as appropriate for the outcome. GEE methods will be used when analyzing the percentage of times additional propofol was administered. Mixed model regression methods will be used when analyzing the total dose administered.||||0.036
71016278|NCT01516684|141540765|OTHER|Marginal mixed model (GEE type)||||||0.094|||||||Mixed Models Analysis|||||||0.094
71016279|NCT01516684|141540766|OTHER|||||||0.382|||||||Chi-squared|||||||0.382
71016280|NCT01516684|141540767|OTHER|Marginal mixed model (GEE type)||||||0.426|||||||Mixed Models Analysis|||||||0.426
71016281|NCT00902486|141540808|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.0619|TWO_SIDED|95.0|0.77|6.15|||Cochran-Armitage trend test||LOGISTIC regression model for odds ratio estimates : LOGIT(Response 0/1) = Treatment + Biologics|The prespecified primary analysis for ACR 20 was the Cochran-Armitage trend test looking for a dose-response relationship. The treatment effect was also assessed using a logistic regression model including background therapy (more than 8 weeks of biologics or not) and treatment.||6.15|0.77|0.0619
71016282|NCT00902486|141540808|OTHER|||||||0.1978|||||||Fisher Exact|||Sensitivity analysis for pairwise comparisons of 4 mg QD versus placebo.||||0.1978
71016283|NCT00902486|141540808|OTHER|||||||0.0437|||||||Fisher Exact|||Sensitivity analysis for pairwise comparisons of 7 mg QD versus placebo.||||0.0437
71016284|NCT00902486|141540808|OTHER|||||||0.1236|||||||Fisher Exact|||Sensitivity analysis for pairwise comparisons of 10 mg QD versus placebo.||||0.1236
71016285|NCT00584831|141540864|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|0.03|STANDARD_DEVIATION|0.16||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
70930406|NCT02938520|141359181|NON_INFERIORITY|Non-inferiority in the proportion of participants with virologic failure at Week 48 (per FDA's snapshot algorithm for assessing HIV-1 RNA \>=50 c/mL) can be concluded if the upper bound of a two-sided 95% confidence interval (CI) for the difference in failure rates between the two treatment arms (CAB - ABC/DTG/3TC) is less than 6%.|Adjusted difference in proportion|-0.4|||||TWO_SIDED|95.0|-2.8|2.1|||||||Adjusted difference in proportion was based on Cochran-Mantel Haenszel stratified analysis adjusting for the following baseline stratification factors: sex at birth (Male, Female) and Induction Baseline (Week -20) HIV-1 RNA (\<100,000 \>=100,000 c/mL)|2.1|-2.8|
71016286|NCT00584831|141540864|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.18||0.02||95.0|||||ANOVA|||Hyposthesis is that visual acuity is the same for all lens types.||||0.02
70930407|NCT02938520|141359182|NON_INFERIORITY|Non-inferiority in the proportion of participants with HIV-1 RNA\<50 c/mL at Week 48 (per FDA's snapshot algorithm) can be concluded if the lower bound of a two-sided 95% confidence interval for the difference in success rates between the two treatment arms (CAB - ABC/DTG/3TC) is more than -10%|Adjusted difference in proportion|0.4|||||TWO_SIDED|95.0|-3.7|4.5|||||Adjusted difference in proportion was based on Cochran-Mantel Haenszel stratified analysis adjusting for the following baseline stratification factors: sex at birth (Male, Female) and Induction Baseline (Week -20) HIV-1 RNA (\<100,000 \>=100,000 c/mL)|||4.5|-3.7|
70930408|NCT02938520|141359235|OTHER||||||<|0.001||||||Week 41/48 was compared with the 1st visit (Week 5) based on Wilcoxon signed-rank test, respectively. p-values are derived for 'Acceptance' only and not adjusted for multiple testing.|Wilcoxon (Mann-Whitney)|||||||<0.001
70930409|NCT02938520|141359237|OTHER||Adjusted difference|1.2||||0.307|TWO_SIDED|95.0|-1.1|3.6|||ANCOVA||Treatment comparison at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||3.6|-1.1|0.307
70930410|NCT02938520|141359237|OTHER||Adjusted difference|0.9||||0.472|TWO_SIDED|95.0|-1.5|3.2|||ANCOVA||Treatment comparison at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||3.2|-1.5|0.472
71016287|NCT00584831|141540864|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.2||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71016288|NCT00584831|141540864|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71016289|NCT00584831|141540864|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.18||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
70930411|NCT02938520|141359238|OTHER||Adjusted difference|1.8||||0.116|TWO_SIDED|95.0|-0.4|3.9|||ANCOVA||Treatment comparison at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||3.9|-0.4|0.116
71016290|NCT00584831|141540864|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|0.18||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71016291|NCT00584831|141540865|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|0.16||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71016292|NCT00584831|141540865|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
70930412|NCT02938520|141359238|OTHER||Adjusted difference|0.1||||0.944|TWO_SIDED|95.0|-2.3|2.5|||ANCOVA||Treatment comparison at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||2.5|-2.3|0.944
71016293|NCT00584831|141540865|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.03|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71016294|NCT00584831|141540865|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.03|STANDARD_DEVIATION|0.19||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71016295|NCT00584831|141540865|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.2||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71016296|NCT00584831|141540865|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71016297|NCT00584831|141540866|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|0.03|STANDARD_DEVIATION|0.13||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71016298|NCT00584831|141540866|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.15||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71016299|NCT00584831|141540866|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71016300|NCT00584831|141540866|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.15||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
70930413|NCT02938520|141359239|OTHER||Adjusted difference|-1.3||||0.552|TWO_SIDED|95.0|-5.7|3.0|||ANCOVA||Treatment comparison at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||3.0|-5.7|0.552
70930414|NCT02938520|141359239|OTHER||Adjusted difference|-4.6||||0.033|TWO_SIDED|95.0|-8.9|-0.4|||ANCOVA||Treatment comparison at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||-0.4|-8.9|0.033
70930415|NCT02938520|141359240|OTHER||Adjusted difference|1.021||||0.122|TWO_SIDED|95.0|-0.275|2.318|||ANCOVA||Treatment comparison of SF-12 MCS at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||2.318|-0.275|0.122
71016301|NCT00584831|141540866|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71016302|NCT00584831|141540866|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.18||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71016303|NCT00584831|141540867|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71016304|NCT00584831|141540867|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.19||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71016305|NCT00584831|141540867|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.2||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71016306|NCT00584831|141540867|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.15||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71016307|NCT00584831|141540867|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|0.18||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71016308|NCT00584831|141540867|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.18||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
70930416|NCT02938520|141359240|OTHER||Adjusted difference|1.103||||0.109|TWO_SIDED|95.0|-0.248|2.453|||ANCOVA||Treatment comparison of SF-12 MCS at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||2.453|-0.248|0.109
70930417|NCT02938520|141359240|OTHER||Adjusted difference|0.182||||0.645|TWO_SIDED|95.0|-0.594|0.958|||ANCOVA||Treatment comparison of SF-12 PCS at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||0.958|-0.594|0.645
71016309|NCT01017731|141540872|SUPERIORITY_OR_OTHER|||||||0.0161||||||The p-value for QTc interval prolongation compared to baseline.|Mixed Models Analysis|||||||0.0161
71016310|NCT01371006|141540923|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|105.61|STANDARD_DEVIATION|22.0|||TWO_SIDED|90.0|90.81|122.82|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (50 mg Efavirenz+240 mg Faldaprevir : 50 mg Efavirenz) of Efavirenz||122.82|90.81|
71016311|NCT01371006|141540924|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|116.12|STANDARD_DEVIATION|18.8|||TWO_SIDED|90.0|101.87|132.35|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (50 mg Efavirenz+240 mg Faldaprevir : 50 mg Efavirenz) of Efavirenz||132.35|101.87|
71016312|NCT01371006|141540925|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|71.83|STANDARD_DEVIATION|23.6|||TWO_SIDED|90.0|61.46|83.95|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz : 7.5 mg Midazolam+240 mg Faldaprevir) of Faldaprevir||83.95|61.46|
71016313|NCT01371006|141540926|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|64.97|STANDARD_DEVIATION|30.2|||TWO_SIDED|90.0|53.32|79.16|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz : 7.5 mg Midazolam+240 mg Faldaprevir) of Faldaprevir||79.16|53.32|
71016314|NCT01371006|141540927|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|54.31|STANDARD_DEVIATION|44.2|||TWO_SIDED|90.0|40.47|72.88|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz : 7.5 mg Midazolam+240 mg Faldaprevir) of Faldaprevir||72.88|40.47|
71016315|NCT03926728|141540950|OTHER|||||||1||||||Simple nonparametric statistical test.|Fisher Exact|||Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs D \[D1, D2\].||||1
71016316|NCT03926728|141540950|OTHER|||||||1||||||Simple nonparametric statistical test.|Fisher Exact|||Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs E \[E1, E2\].||||1
71016317|NCT03926728|141540950|OTHER|||||||0.0007|||||||Fisher Exact|||Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs F \[F1, F2\].||||0.0007
71016318|NCT03926728|141540953|OTHER|||||||1||||||Simple nonparametric statistical test.|Fisher Exact|||Comparison: Cohort B \[B1, B2\] vs A2.||||1
71016319|NCT03926728|141540953|OTHER|||||||0.3956|||||||Fisher Exact|||Comparison: Cohort B \[B1, B2\] vs F1.||||0.3956
71016320|NCT03926728|141540954|OTHER|||||||1||||||Simple nonparametric statistical test.|Fisher Exact|||Comparison: Cohort B \[B1, B2\] vs A2.||||1
71016321|NCT03926728|141540954|OTHER|||||||0.3956|||||||Fisher Exact|||Comparison: Cohort B \[B1, B2\] vs F1.||||0.3956
71016322|NCT03926728|141540956|OTHER|||||||1||||||Simple nonparametric statistical test.|Fisher Exact|||Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs D \[D1, D2\].||||1
71016323|NCT03926728|141540956|OTHER|||||||1||||||Simple nonparametric statistical test.|Fisher Exact|||Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs E \[E1, E2\].||||1
71050030|NCT02504671|141606197|OTHER||Mean Difference (Net)|-0.64||||0.814|TWO_SIDED|95.0|-5.98|4.7||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Physical Functioning|||4.70|-5.98|0.814
71050031|NCT02504671|141606197|OTHER||Mean Difference (Net)|-0.41||||0.873|TWO_SIDED|95.0|-5.49|4.67||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Physical Functioning|||4.67|-5.49|0.873
71050032|NCT02504671|141606197|OTHER||Mean Difference (Net)|0.23||||0.928|TWO_SIDED|95.0|-4.8|5.26||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Physical Functioning|||5.26|-4.80|0.928
71104928|NCT00619866|141716965|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.14||0.0021|TWO_SIDED|95.0|-0.72|-0.16|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.16|-0.72|0.0021
71016324|NCT03926728|141540956|OTHER|||||||0.3229|||||||Fisher Exact|||Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs F \[F1, F2\].||||0.3229
71016325|NCT01107834|141540961|SUPERIORITY_OR_OTHER|||||||0.27|||||||t-test, 2 sided|||T-test to detect differences between groups||||0.27
71016326|NCT01107834|141540962|SUPERIORITY_OR_OTHER|||||||0.46|||||||t-test, 2 sided|||T-test to detect differences between groups||||0.46
71016327|NCT01107834|141540963|SUPERIORITY_OR_OTHER|||||||0.13|||||||t-test, 2 sided|||T-test to detect differences between groups||||0.13
71016328|NCT01107834|141540964|SUPERIORITY_OR_OTHER|||||||0.59|||||||t-test, 2 sided|||T-test to detect differences between groups||||0.59
71016329|NCT01107834|141540965|SUPERIORITY_OR_OTHER|||||||0.09|||||||t-test, 2 sided|||T-test to detect differences between groups||||0.09
71104929|NCT00619866|141716965|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.14||0.0003|TWO_SIDED|95.0|-0.8|-0.24|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.24|-0.80|0.0003
71016330|NCT01107834|141540966|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 2 sided|||T-test to detect differences between groups||||0.03
71016331|NCT02118896|141540994|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9257|||||TWO_SIDED|95.0|0.844|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.000|0.844|
71016332|NCT02118896|141540994|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9321|||||TWO_SIDED|95.0|0.858|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.000|0.858|
71016333|NCT02118896|141540994|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.0000|1.0000|
71016334|NCT02118896|141540994|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.8699|||||TWO_SIDED|95.0|0.79|0.949||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||0.949|0.790|
71016335|NCT02118896|141540994|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9607|||||TWO_SIDED|95.0|0.927|0.995||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||0.995|0.927|
71016336|NCT02118896|141540994|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9948|||||TWO_SIDED|95.0|0.985|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.000|0.985|
71016337|NCT02118896|141540994|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.0000|1.0000|
71016338|NCT02118896|141540994|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.0000|1.0000|
71050033|NCT02504671|141606197|OTHER||Mean Difference (Net)|-1.29||||0.541|TWO_SIDED|95.0|-5.44|2.86||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Emotional|||2.86|-5.44|0.541
71050034|NCT02504671|141606197|OTHER||Mean Difference (Net)|-1.29||||0.535|TWO_SIDED|95.0|-5.39|2.81||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Emotional|||2.81|-5.39|0.535
71050035|NCT02504671|141606197|OTHER||Mean Difference (Net)|-1.03||||0.62|TWO_SIDED|95.0|-5.1|3.05||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Emotional|||3.05|-5.10|0.620
70930418|NCT02938520|141359240|OTHER||Adjusted difference|-0.169||||0.689|TWO_SIDED|95.0|-0.994|0.657|||ANCOVA||Treatment comparison of SF-12 PCS at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||0.657|-0.994|0.689
71050036|NCT02504671|141606197|OTHER||Mean Difference (Net)|0.34||||0.881|TWO_SIDED|95.0|-4.08|4.76||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Role Emotional|||4.76|-4.08|0.881
71050037|NCT02504671|141606197|OTHER||Mean Difference (Net)|0.66||||0.767|TWO_SIDED|95.0|-3.74|5.07||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,Role Emotional|||5.07|-3.74|0.767
71050038|NCT02504671|141606197|OTHER||Mean Difference (Net)|0.24||||0.913|TWO_SIDED|95.0|-4.12|4.61||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Role Emotional|||4.61|-4.12|0.913
71050039|NCT02504671|141606197|OTHER||Mean Difference (Net)|0.91||||0.79|TWO_SIDED|95.0|-5.81|7.63||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Emotional|||7.63|-5.81|0.790
71050040|NCT02504671|141606197|OTHER||Mean Difference (Net)|0.5||||0.876|TWO_SIDED|95.0|-5.86|6.87||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Emotional|||6.87|-5.86|0.876
71050041|NCT02504671|141606197|OTHER||Mean Difference (Net)|-1.3||||0.684|TWO_SIDED|95.0|-7.59|4.99||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Emotional|||4.99|-7.59|0.684
71050042|NCT02504671|141606197|OTHER||Mean Difference (Net)|0.86||||0.588|TWO_SIDED|95.0|-2.28|4.01||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Physical|||4.01|-2.28|0.588
71050043|NCT02504671|141606197|OTHER||Mean Difference (Net)|1.9||||0.229|TWO_SIDED|95.0|-1.21|5.0||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Physical|||5.00|-1.21|0.229
71050044|NCT02504671|141606197|OTHER||Mean Difference (Net)|2.41||||0.125|TWO_SIDED|95.0|-0.67|5.49||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Physical|||5.49|-0.67|0.125
71050045|NCT02504671|141606197|OTHER||Mean Difference (Net)|0.6||||0.736|TWO_SIDED|95.0|-2.92|4.12||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Role Physical|||4.12|-2.92|0.736
71050046|NCT02504671|141606197|OTHER||Mean Difference (Net)|1.72||||0.338|TWO_SIDED|95.0|-1.8|5.23||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Role Physical|||5.23|-1.80|0.338
71050047|NCT02504671|141606197|OTHER||Mean Difference (Net)|0.92||||0.6|TWO_SIDED|95.0|-2.55|4.4||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Role Physical|||4.40|-2.55|0.600
71050048|NCT02504671|141606197|OTHER||Mean Difference (Net)|1.26||||0.657|TWO_SIDED|95.0|-4.34|6.86||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Physical|||6.86|-4.34|0.657
71050049|NCT02504671|141606197|OTHER||Mean Difference (Net)|-0.12||||0.965|TWO_SIDED|95.0|-5.41|5.17||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Physical|||5.17|-5.41|0.965
71050050|NCT02504671|141606197|OTHER||Mean Difference (Net)|1.12||||0.675|TWO_SIDED|95.0|-4.14|6.37||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Physical|||6.37|-4.14|0.675
71050051|NCT02504671|141606197|OTHER||Mean Difference (Net)|-0.32||||0.88|TWO_SIDED|95.0|-4.54|3.89||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Social Functioning|||3.89|-4.54|0.880
71050052|NCT02504671|141606197|OTHER||Mean Difference (Net)|3.17||||0.135|TWO_SIDED|95.0|-1.0|7.33||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Social Functioning|||7.33|-1.00|0.135
71050053|NCT02504671|141606197|OTHER||Mean Difference (Net)|0.57||||0.785|TWO_SIDED|95.0|-3.56|4.71||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Social Functioning|||4.71|-3.56|0.785
71050054|NCT02504671|141606197|OTHER||Mean Difference (Net)|0.55||||0.797|TWO_SIDED|95.0|-3.69|4.8||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Social Functioning|||4.80|-3.69|0.797
71050055|NCT02504671|141606197|OTHER||Mean Difference (Net)|0.0|||>|0.999|TWO_SIDED|95.0|-4.23|4.23||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Social Functioning|||4.23|-4.23|>0.999
71050056|NCT02504671|141606197|OTHER||Mean Difference (Net)|0.28||||0.896|TWO_SIDED|95.0|-3.91|4.46||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Social Functioning|||4.46|-3.91|0.896
71050057|NCT02504671|141606197|OTHER||Mean Difference (Net)|-2.89||||0.424|TWO_SIDED|95.0|-10.02|4.24||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Social Functioning|||4.24|-10.02|0.424
71016339|NCT02118896|141540994|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9773|||||TWO_SIDED|95.0|0.933|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.000|0.933|
71016340|NCT02118896|141540997|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.8391|||||TWO_SIDED|95.0|0.729|0.949||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||0.949|0.729|
71104930|NCT00619866|141716966|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.09||0.0603|TWO_SIDED|95.0|-0.34|0.01|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.01|-0.34|0.0603
71016341|NCT02118896|141540997|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.8792|||||TWO_SIDED|95.0|0.778|0.981||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula..||0.981|0.778|
71016342|NCT02118896|141540997|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.8816|||||TWO_SIDED|95.0|0.782|0.981||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||0.981|0.782|
71016343|NCT02118896|141540997|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.7769|||||TWO_SIDED|95.0|0.675|0.878||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||0.878|0.675|
71016344|NCT02118896|141540997|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.8373|||||TWO_SIDED|95.0|0.693|0.981||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||0.981|0.693|
71016345|NCT02118896|141540997|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9419|||||TWO_SIDED|95.0|0.883|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||1.000|0.883|
71016346|NCT02118896|141540997|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||1.000|1.000|
71016347|NCT02118896|141540997|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9898|||||TWO_SIDED|95.0|0.97|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||1.000|0.970|
71016348|NCT02118896|141540997|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9773|||||TWO_SIDED|95.0|0.933|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||1.000|0.933|
71016349|NCT02050373|141540999|OTHER|For the comparison between the LLLT and control groups the Pearson chi-square (χ2) or Fisher's Exact tests were used.|||||<|0.05|||||||Fisher Exact|||The Pearson chi-square (χ2) or Fisher's Exact tests were used, at three different times (AD, D7, HD), to analyze the oral mucositis severity in the comparison between the LLLT and control groups. Statistical analysis was not performed for each grade of oral mucositis separately.||||<0.05
71029498|NCT02480764|141566922|OTHER||Odds Ratio (OR)|1.045|STANDARD_ERROR_OF_MEAN|0.2788||0.868|TWO_SIDED|95.0|0.62|1.763||Clinic DBP \<90 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic|||||1.763|0.620|0.868
71029499|NCT02480764|141566922|OTHER||Odds Ratio (OR)|1.042|STANDARD_ERROR_OF_MEAN|0.2244||0.847|TWO_SIDED|95.0|0.684|1.59||Clinic SBP\<140 mm Hg and DBP\<90 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.590|0.684|0.847
71029500|NCT02480764|141566922|OTHER||Odds Ratio (OR)|1.172|STANDARD_ERROR_OF_MEAN|0.2517||0.46|TWO_SIDED|95.0|0.769|1.785||Clinic SBP\<140 mm Hg and DBP\<90 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.785|0.769|0.460
71029501|NCT02480764|141566923|OTHER||Odds Ratio (OR)|1.487|STANDARD_ERROR_OF_MEAN|0.3333||0.077|TWO_SIDED|95.0|0.958|2.307||Clinic SBP\<130 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||2.307|0.958|0.077
71029502|NCT02480764|141566923|OTHER||Odds Ratio (OR)|1.914|STANDARD_ERROR_OF_MEAN|0.4229||0.003|TWO_SIDED|95.0|1.241|2.951||Clinic SBP\<130 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||2.951|1.241|0.003
71029503|NCT02480764|141566923|OTHER||Odds Ratio (OR)|1.427|STANDARD_ERROR_OF_MEAN|0.3414||0.137|TWO_SIDED|95.0|0.893|2.28||Clinic DBP\<80 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic|||||2.280|0.893|0.137
71029504|NCT02480764|141566923|OTHER||Odds Ratio (OR)|2.017|STANDARD_ERROR_OF_MEAN|0.4816||0.003|TWO_SIDED|95.0|1.263|3.22||Clinic DBP \<80 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic|||||3.220|1.263|0.003
71029505|NCT02480764|141566923|OTHER||Odds Ratio (OR)|1.424|STANDARD_ERROR_OF_MEAN|0.3407||0.14|TWO_SIDED|95.0|0.891|2.276||Clinic SBP\<130 mm Hg and DBP\<80 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||2.276|0.891|0.140
71029506|NCT02480764|141566923|OTHER||Odds Ratio (OR)|1.769|STANDARD_ERROR_OF_MEAN|0.4136||0.015|TWO_SIDED|95.0|1.118|2.797||Clinic SBP\<130 mm Hg and DBP\<80 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||2.797|1.118|0.015
71029507|NCT03629249|141566924|SUPERIORITY|||||||0.714|||||||Wilcoxon (Mann-Whitney)|||||||0.714
71016350|NCT02050373|141541000|OTHER|Student's t test was used to numerical variables with normal distribution. The Mann-Whitney test was used to compare the cytokine values of the two groups (control and laser). The Friedman test was used to indicate differences by comparing cytokine levels at different times of assessment within each group. The Friedman and Wilcoxon tests were used for paired analyzes of the saliva collection times in the groups. All tests were used to compare the groups at the three different times (AD, D7, HD).|||||<|0.05||||||p\<0,05|Wilcoxon (Mann-Whitney)|||||||<0.05
71016351|NCT01569074|141541032|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.23||||0.059|TWO_SIDED|80.0|0.07|0.39||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||0.39|0.07|0.059
71016352|NCT01569074|141541032|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.24||||0.054|TWO_SIDED|80.0|0.08|0.39||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.39|0.08|0.054
71016353|NCT01569074|141541032|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.06||||0.57|TWO_SIDED|80.0|-0.2|0.08||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.08|-0.20|0.570
71016354|NCT01569074|141541032|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.14||||0.262|TWO_SIDED|80.0|-0.02|0.29||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.29|-0.02|0.262
71016355|NCT01569074|141541033|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.11||||0.172|TWO_SIDED|80.0|0.01|0.21||Week 1|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.21|0.01|0.172
71016356|NCT01569074|141541033|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.06||||0.489|TWO_SIDED|80.0|-0.05|0.18||Week 1|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.18|-0.05|0.489
71016357|NCT01569074|141541033|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.03||||0.704|TWO_SIDED|80.0|-0.08|0.15||Week 1|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.15|-0.08|0.704
71016358|NCT01569074|141541034|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.17||||0.114|TWO_SIDED|80.0|0.03|0.31||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.31|0.03|0.114
71016359|NCT01569074|141541034|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.21||||0.035|TWO_SIDED|80.0|0.08|0.34||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.34|0.08|0.035
71029508|NCT03629249|141566924|SUPERIORITY|||||||0.734|||||||Wilcoxon (Mann-Whitney)|||||||0.734
71029509|NCT03629249|141566925|SUPERIORITY|||||||0.665|||||||Wilcoxon (Mann-Whitney)|||||||0.665
71029510|NCT03629249|141566925|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.910
70850706|NCT04518995|141189574|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||<0.0001
70850707|NCT04518995|141189574|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||<0.0001
70930419|NCT02938520|141359241|OTHER||Adjusted difference|2.2|||<|0.001|TWO_SIDED|95.0|1.0|3.4|||ANCOVA||Treatment comparison at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||3.4|1.0|<0.001
70850708|NCT04518995|141189574|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||<0.0001
70850709|NCT04518995|141189574|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||<0.0001
70930420|NCT02938520|141359241|OTHER||Adjusted difference|0.7||||0.217|TWO_SIDED|95.0|-0.4|1.9|||ANCOVA||Treatment comparison at Week 44 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||1.9|-0.4|0.217
71016360|NCT01569074|141541034|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.07||||0.334|TWO_SIDED|80.0|-0.17|0.02||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.02|-0.17|0.334
71016361|NCT01569074|141541034|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.04||||0.645|TWO_SIDED|80.0|-0.13|0.06||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.06|-0.13|0.645
71016362|NCT01569074|141541035|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.12||||0.028|TWO_SIDED|80.0|0.05|0.19||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.19|0.05|0.028
71016363|NCT01569074|141541035|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.14||||0.021|TWO_SIDED|80.0|0.06|0.22||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.22|0.06|0.021
71016364|NCT01569074|141541036|SUPERIORITY_OR_OTHER|||||||0.073||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-value estimated using the Van Elteren method stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||||0.073
71016365|NCT01569074|141541036|SUPERIORITY_OR_OTHER|||||||0.065||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-value estimated using the Van Elteren test stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||||0.065
71016366|NCT01569074|141541036|SUPERIORITY_OR_OTHER|||||||0.317||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-value estimated using the Van Elteren method stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||||0.317
71029511|NCT01475474|141566936|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Signed-Rank Test|||Wilcoxon Signed-Rank Test used to evaluate median Percent Change-from-Baseline in ABL different from zero||||<0.001
71029512|NCT01475474|141566937|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Signed-Rank Test|||Wilcoxon Signed-Rank Test used to evaluate median Percent Change-from-Baseline in Wexner score||||<0.001
71029513|NCT01030965|141566938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|||<|0.001|TWO_SIDED|95.0|0.088|0.229|||Repeated Measures Analysis of Covariance|||||0.229|0.088|<0.001
71029514|NCT01030965|141566938|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.168|||<|0.001|TWO_SIDED|95.0|0.099|0.238|||Repeated Measures Analysis of Covariance|||||0.238|0.099|<0.001
71029515|NCT01030965|141566938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|||<|0.001|TWO_SIDED|95.0|0.08|0.22|||Repeated Measures Analysis of Covariance|||||0.220|0.080|<0.001
71104931|NCT00619866|141716966|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.09||0.1855|TWO_SIDED|95.0|-0.29|0.06|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.06|-0.29|0.1855
71104932|NCT00619866|141716966|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.09||0.0012|TWO_SIDED|95.0|-0.48|-0.12|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.12|-0.48|0.0012
70930421|NCT02938520|141359242|OTHER||Difference|4.1|||<|0.001|TWO_SIDED|95.0|2.8|5.5|||ANOVA||Treatment comparison of HIVTSQc-total treatment satisfaction score at Week 48 is presented, adjusted for Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||5.5|2.8|<0.001
71050058|NCT02504671|141606197|OTHER||Mean Difference (Net)|-0.44||||0.898|TWO_SIDED|95.0|-7.16|6.29||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Social Functioning|||6.29|-7.16|0.898
70930422|NCT02938520|141359244|OTHER||Adjusted difference|2.2||||0.232|TWO_SIDED|95.0|-1.4|5.7|||ANCOVA||Treatment comparison at Week 8 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||5.7|-1.4|0.232
71050059|NCT02504671|141606197|OTHER||Mean Difference (Net)|-3.79||||0.26|TWO_SIDED|95.0|-10.42|2.84||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Social Functioning|||2.84|-10.42|0.260
71050060|NCT02504671|141606197|OTHER||Mean Difference (Net)|1.02||||0.603|TWO_SIDED|95.0|-2.85|4.9||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Vitality|||4.90|-2.85|0.603
71050061|NCT02504671|141606197|OTHER||Mean Difference (Net)|3.56||||0.068|TWO_SIDED|95.0|-0.26|7.39||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Vitality|||7.39|-0.26|0.068
71050062|NCT02504671|141606197|OTHER||Mean Difference (Net)|2.63||||0.174|TWO_SIDED|95.0|-1.17|6.43||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Vitality|||6.43|-1.17|0.174
71050063|NCT02504671|141606197|OTHER||Mean Difference (Net)|1.97||||0.334|TWO_SIDED|95.0|-2.04|5.98||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Vitality|||5.98|-2.04|0.334
71050064|NCT02504671|141606197|OTHER||Mean Difference (Net)|2.91||||0.153|TWO_SIDED|95.0|-1.09|6.91||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Vitality|||6.91|-1.09|0.153
71050065|NCT02504671|141606197|OTHER||Mean Difference (Net)|2.18||||0.279|TWO_SIDED|95.0|-1.78|6.13||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Vitality|||6.13|-1.78|0.279
71050066|NCT02504671|141606197|OTHER||Mean Difference (Net)|1.94||||0.584|TWO_SIDED|95.0|-5.04|8.91||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,Vitality|||8.91|-5.04|0.584
71050067|NCT02504671|141606197|OTHER||Mean Difference (Net)|3.15||||0.346|TWO_SIDED|95.0|-3.44|9.73||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Vitality|||9.73|-3.44|0.346
71050068|NCT02504671|141606197|OTHER||Mean Difference (Net)|2.97||||0.37|TWO_SIDED|95.0|-3.55|9.48||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Vitality|||9.48|-3.55|0.370
71050069|NCT02504671|141606197|OTHER||Mean Difference (Net)|2.94||||0.045|TWO_SIDED|95.0|0.06|5.83||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, PCS|||5.83|0.06|0.045
71050070|NCT02504671|141606197|OTHER||Mean Difference (Net)|4.11||||0.006|TWO_SIDED|95.0|1.22|7.01||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, PCS|||7.01|1.22|0.006
71104933|NCT00619866|141716966|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.1002|TWO_SIDED|95.0|-0.33|0.03|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.03|-0.33|0.1002
71050071|NCT02504671|141606197|OTHER||Mean Difference (Net)|1.89||||0.264|TWO_SIDED|95.0|-1.44|5.23||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,PCS|||5.23|-1.44|0.264
71050072|NCT02504671|141606197|OTHER||Mean Difference (Net)|3.55||||0.037|TWO_SIDED|95.0|0.22|6.88||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,PCS|||6.88|0.22|0.037
71050073|NCT02504671|141606197|OTHER||Mean Difference (Net)|2.16||||0.392|TWO_SIDED|95.0|-2.81|7.14||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, PCS|||7.14|-2.81|0.392
71050074|NCT02504671|141606197|OTHER||Mean Difference (Net)|1.65||||0.493|TWO_SIDED|95.0|-3.09|6.39||MMRM analysis adjusted for PCS Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, PCS|||6.39|-3.09|0.493
71050075|NCT02504671|141606197|OTHER||Mean Difference (Net)|1.16||||0.577|TWO_SIDED|95.0|-2.94|5.26||MMRM analysis adjusted for MCS Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, MCS|||5.26|-2.94|0.577
71050076|NCT02504671|141606197|OTHER||Mean Difference (Net)|0.1||||0.964|TWO_SIDED|95.0|-4.01|4.2||MMRM analysis adjusted for MCS Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, MCS|||4.20|-4.01|0.964
71050077|NCT02504671|141606197|OTHER||Mean Difference (Net)|1.97||||0.37|TWO_SIDED|95.0|-2.35|6.28||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, MCS|||6.28|-2.35|0.370
71050078|NCT02504671|141606197|OTHER||Mean Difference (Net)|3.25||||0.138|TWO_SIDED|95.0|-1.05|7.54||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, MCS|||7.54|-1.05|0.138
70930423|NCT02938520|141359244|OTHER||Adjusted difference|2.7||||0.154|TWO_SIDED|95.0|-1.0|6.4|||ANCOVA||Treatment comparison Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||6.4|-1.0|0.154
71016367|NCT01569074|141541036|SUPERIORITY_OR_OTHER|||||||0.263||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-value estimated using the Van Elteren method stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||||0.263
71016368|NCT01569074|141541037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.3||||0.033|TWO_SIDED|80.0|1.94|14.31|||Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||14.31|1.94|0.033
71016369|NCT01569074|141541037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.1||||0.033|TWO_SIDED|80.0|1.92|13.61|||Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||13.61|1.92|0.033
71016370|NCT01569074|141541037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.257|TWO_SIDED|80.0|0.89|6.89|||Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||6.89|0.89|0.257
71016371|NCT01569074|141541037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.481|TWO_SIDED|80.0|0.63|5.04|||Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||5.04|0.63|0.481
71016372|NCT01569074|141541038|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.131|TWO_SIDED|80.0|1.12|4.2|||Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||4.20|1.12|0.131
71016373|NCT01569074|141541038|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.423|TWO_SIDED|80.0|0.79|2.82|||Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||2.82|0.79|0.423
71016374|NCT01569074|141541038|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.781|TWO_SIDED|80.0|0.45|1.67|||Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||1.67|0.45|0.781
71029516|NCT01868009|141566969|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The response was analyzed and adjusted for study inhaler use sequence and preference question version. The method accounted for participants who indicated no preference.|Cochran-Mantel-Haenszel|||||||<0.001
71029517|NCT00743197|141566972|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|0|Other|0.0|STANDARD_DEVIATION|0.0||||||||0||||0||||
71029518|NCT02130466|141566995|OTHER||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.29|0.74|||||Cox regression model|||0.74|0.29|
71050079|NCT02504671|141606197|OTHER||Mean Difference (Net)|1.36||||0.667|TWO_SIDED|95.0|-4.85|7.56||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, MCS|||7.56|-4.85|0.667
71050080|NCT02504671|141606197|OTHER||Mean Difference (Net)|3.79||||0.203|TWO_SIDED|95.0|-4.85|7.56||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, MCS|||7.56|-4.85|0.203
71029519|NCT02130466|141567002|OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.38|0.95|||||Cox regression model|||0.95|0.38|
71029520|NCT04529109|141567063|SUPERIORITY|The superiority of the Test lens was concluded if the lower limit of the 95% credible interval was above 0.90.|Mean Proportion|0.9998|STANDARD_DEVIATION|0.0005|||TWO_SIDED|95.0|0.999|1.0|||Bayesian Binary model||Interval presented is a 95% Credible interval.|||1.000|0.999|
71050081|NCT02504671|141606197|OTHER||Mean Difference (Net)|3.45||||0.023|TWO_SIDED|95.0|0.49|6.41||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Bodily pain|||6.41|0.49|0.023
71050082|NCT02504671|141606197|OTHER||Mean Difference (Net)|5.08|||<|0.001|TWO_SIDED|95.0|2.14|8.03||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Bodily pain|||8.03|2.14|<0.001
71016375|NCT01569074|141541038|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.239|TWO_SIDED|80.0|0.95|3.44|||Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||3.44|0.95|0.239
71016376|NCT01569074|141541039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.169|TWO_SIDED|80.0|1.06|4.67||Week 12|Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ration \>1 indicates a benefit towards fostamatinib|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||4.67|1.06|0.169
71016377|NCT01569074|141541039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.833|TWO_SIDED|80.0|0.45|1.78||Week 12|Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||1.78|0.45|0.833
71016378|NCT01569074|141541039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.614|TWO_SIDED|80.0|0.37|1.54||Week 12|Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||1.54|0.37|0.614
71016379|NCT01569074|141541039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.748|TWO_SIDED|80.0|0.42|1.69||Week 12|Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||1.69|0.42|0.748
71016380|NCT01569074|141541040|SUPERIORITY_OR_OTHER||Treatment difference|3.01||||0.087|TWO_SIDED|80.0|0.76|5.26|||ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||5.26|0.76|0.087
71016381|NCT01569074|141541040|SUPERIORITY_OR_OTHER||Treatment difference|0.25||||0.881|TWO_SIDED|80.0|-1.91|2.41|||ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||2.41|-1.91|0.881
71050083|NCT02504671|141606197|OTHER||Mean Difference (Net)|2.11||||0.249|TWO_SIDED|95.0|-1.49|5.7||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Bodily pain|||5.70|-1.49|0.249
71050084|NCT02504671|141606197|OTHER||Mean Difference (Net)|3.43||||0.059|TWO_SIDED|95.0|-0.13|6.99||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Bodily pain|||6.99|-0.13|0.059
71050085|NCT02504671|141606197|OTHER||Mean Difference (Net)|4.72||||0.134|TWO_SIDED|95.0|-1.47|10.9||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Bodily pain|||10.90|-1.47|0.134
71050086|NCT02504671|141606197|OTHER||Mean Difference (Net)|5.2||||0.078|TWO_SIDED|95.0|-0.58|10.97||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Bodily pain|||10.97|-0.58|0.078
71050087|NCT02504671|141606197|OTHER||Mean Difference (Net)|1.65||||0.275|TWO_SIDED|95.0|-1.32|4.62||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, General health|||4.62|-1.32|0.275
71050088|NCT02504671|141606197|OTHER||Mean Difference (Net)|1.94||||0.199|TWO_SIDED|95.0|-1.03|4.91||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, General health|||4.91|-1.03|0.199
70850710|NCT04518995|141189575|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-0.7|-1.2|<0.0001
71050089|NCT02504671|141606197|OTHER||Mean Difference (Net)|0.69||||0.654|TWO_SIDED|95.0|-2.36|3.74||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, General health|||3.74|-2.36|0.654
71050090|NCT02504671|141606197|OTHER||Mean Difference (Net)|2.29||||0.138|TWO_SIDED|95.0|-0.74|5.33||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, General health|||5.33|-0.74|0.138
71050091|NCT02504671|141606197|OTHER||Mean Difference (Net)|1.77||||0.516|TWO_SIDED|95.0|-3.62|7.17||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, General health|||7.17|-3.62|0.516
71050092|NCT02504671|141606197|OTHER||Mean Difference (Net)|3.35||||0.198|TWO_SIDED|95.0|-1.77|8.46||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, General health|||8.46|-1.77|0.198
70930424|NCT02938520|141359244|OTHER||Adjusted difference|2.2||||0.236|TWO_SIDED|95.0|-1.4|5.8|||ANCOVA||Treatment comparison at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||5.8|-1.4|0.236
70930425|NCT05275556|141359246|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.0002|TWO_SIDED|95.0|0.07|0.23||Threshold for significance is 0.025.|Poisson Regression|||||0.23|0.07|0.0002
70930426|NCT05275556|141359247|NON_INFERIORITY|Non-inferiority margin is -10%.|Mean Difference (Final Values)|-0.06||||0.09|TWO_SIDED|95.0|-0.15|0.03||Threshold for significance is 0.025.|Resampling based|||||0.03|-0.15|0.09
70930427|NCT05275556|141359248|SUPERIORITY||Difference in percentage|5.5||||0.031|TWO_SIDED|95.0|-0.3|11.2|||Cochran-Mantel-Haenszel|Threshold for significance is 0.025.||||11.2|-0.3|0.031
70930428|NCT05275556|141359249|OTHER||rate|0.58|||||TWO_SIDED|||||||||||||
70930429|NCT05275556|141359250|OTHER|2 sided test for differences between arms|Mean Difference (Final Values)|0.58||||0.169|TWO_SIDED||||||Permutation test|||||||0.169
70930430|NCT05275556|141359251|OTHER||||||||||||||||||Descriptive analysis: 52.4 in Colonoscopy (Standard of Care), 59.6 in CAD-e Device|||
70930431|NCT05275556|141359252|SUPERIORITY||Mean Difference (Net)|4.6||||0.0578|TWO_SIDED|95.0|-0.2|9.4||Nominal p-value.|Cochran-Mantel-Haenszel|||Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \<= CADe Device percentage (i.e. test of superiority)||9.4|-0.2|0.0578
70930432|NCT05275556|141359253|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.7813|TWO_SIDED|95.0|-1.5|2.0||Nominal p-value|Cochran-Mantel-Haenszel|||Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \<= CADe Device percentage (i.e. test of superiority)||2.0|-1.5|0.7813
70930433|NCT05275556|141359254|SUPERIORITY||Least-squares means|0.11|||||TWO_SIDED|95.0|0.05|0.17||||||||0.17|0.05|
71016382|NCT01569074|141541040|SUPERIORITY_OR_OTHER||Treatment difference|-0.42||||0.806|TWO_SIDED|80.0|-2.64|1.8|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||1.80|-2.64|0.806
70850711|NCT04518995|141189575|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.5|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-0.9|-1.5|<0.0001
70850712|NCT04518995|141189575|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-0.9|-1.4|<0.0001
70930434|NCT05275556|141359255|SUPERIORITY||Mean Difference (Final Values)|8.3||||0.0004|TWO_SIDED|95.0|3.7|12.9||Nominal p-value|Cochran-Mantel-Haenszel|||Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \<= CADe Device percentage (i.e. test of superiority)||12.9|3.7|0.0004
70930435|NCT05275556|141359256|SUPERIORITY||Mean Difference (Final Values)|4.1||||0.1185|TWO_SIDED|95.0|-1.0|9.1||Nominal p-value|Cochran-Mantel-Haenszel|||Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \<= CADe Device percentage (i.e. test of superiority)||9.1|-1|0.1185
70930436|NCT05275556|141359257|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.0752|TWO_SIDED|95.0|-0.4|9.2||nominal p-value|Cochran-Mantel-Haenszel|||Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \<= CADe Device percentage (i.e. test of superiority)||9.2|-0.4|0.0752
70930437|NCT05275556|141359259|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.8194|TWO_SIDED|95.0|-3.2|2.6||Nominal p-value|Cochran-Mantel-Haenszel|||Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \<= CADe Device percentage (i.e. test of superiority)||2.6|-3.2|0.8194
70930438|NCT05275556|141359260|OTHER|Test for difference|Incidence Rate Ratio|1.39||||0.0008|TWO_SIDED|95.0|1.14|1.69||Nominal p-value|Exact poisson|||||1.69|1.14|0.0008
70930439|NCT04564209|141359326|SUPERIORITY|||||||0.455|||||||ANOVA|||||||.455
70930440|NCT04564209|141359327|SUPERIORITY|||||||0.415|||||||ANOVA|||||||.415
70930441|NCT04564209|141359328|SUPERIORITY|||||||0.443|||||||ANOVA|||||||.443
70930442|NCT04564209|141359329|SUPERIORITY|||||||0.457|||||||ANOVA|||||||.457
70930443|NCT04564209|141359330|SUPERIORITY|||||||0.099|||||||ANOVA|||||||.099
70930444|NCT04564209|141359331|SUPERIORITY|||||||0.338|||||||ANOVA|||||||.338
70930445|NCT04564209|141359332|SUPERIORITY|||||||0.723|||||||ANOVA|||||||.723
70930446|NCT04564209|141359334|SUPERIORITY|||||||0.578|||||||t-test, 2 sided|||||||.578
70930447|NCT04564209|141359335|SUPERIORITY|||||||0.998|||||||t-test, 2 sided|||||||.998
70930448|NCT04564209|141359336|SUPERIORITY|||||||0.864|||||||t-test, 2 sided|||||||.864
70930449|NCT05257603|141359337|OTHER||Mean Difference (Net)|4.82|STANDARD_ERROR_OF_MEAN|0.615|<|0.99|TWO_SIDED|95.0|3.24|5.72|||ANOVA|||||5.72|3.24|<0.99
70930450|NCT05257603|141359338|OTHER||||||<|0.29|||||||Chi-squared|||||||<.29
70930451|NCT05257603|141359339|OTHER||||||<|0.99|||||||ANOVA|||A one-way ANOVA was used to compare the mean difference in key presses from time 1 to time 2 between the intervention (RPCW) and Control conditions.||||<0.99
70930452|NCT05257603|141359340|OTHER||||||<|0.45|||||||ANOVA|||||||<0.45
70930453|NCT05257603|141359341|OTHER||||||<|0.1||||||Given the exploratory nature of the analysis we were looking for a trend in improvement in emotion regulation (i.e., p\<.10) following the intervention condition compared to control.|ANOVA|||||||<.10
70930454|NCT05257603|141359342|OTHER||||||<|0.1|||||||ANOVA|||Repeated measure ANOVA was used to provide preliminary information for estimating sample sizes needed for a larger Stage II efficacy trial. The current pilot RCT was not powered to find significant effects.||||<.10
71016383|NCT01569074|141541040|SUPERIORITY_OR_OTHER||Treatment difference|1.03||||0.548|TWO_SIDED|80.0|-1.17|3.23|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||3.23|-1.17|0.548
71016384|NCT01569074|141541041|SUPERIORITY_OR_OTHER||Treatment difference|3.12||||0.139|TWO_SIDED|80.0|0.42|5.82|||ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||5.82|0.42|0.139
71016385|NCT01569074|141541041|SUPERIORITY_OR_OTHER||Treatment difference|2.47||||0.223|TWO_SIDED|80.0|-0.13|5.07|||ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||5.07|-0.13|0.223
71016386|NCT01569074|141541041|SUPERIORITY_OR_OTHER||Treatment difference|-1.63||||0.432|TWO_SIDED|80.0|-4.3|1.04|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||1.04|-4.30|0.432
71050093|NCT02504671|141606197|OTHER||Mean Difference (Net)|-0.15||||0.941|TWO_SIDED|95.0|-4.15|3.84||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Mental health|||3.84|-4.15|0.941
71050094|NCT02504671|141606197|OTHER||Mean Difference (Net)|0.05||||0.979|TWO_SIDED|95.0|-3.94|4.05||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Mental health|||4.05|-3.94|0.979
71104934|NCT00619866|141716966|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.09||0.0568|TWO_SIDED|95.0|-0.36|0.01|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.01|-0.36|0.0568
71104935|NCT00619866|141716966|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.119|TWO_SIDED|95.0|-0.33|0.04|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.04|-0.33|0.1190
71104936|NCT01968980|141717012|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-54.5|STANDARD_ERROR_OF_MEAN|2.54|<|0.001|TWO_SIDED|95.0|-59.5|-49.5|||Mixed Model Repeated Measures (MMRM)|||LS-mean difference,associated 95 percent (%) confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-49.5|-59.5|<0.001
71104937|NCT01968980|141717013|SUPERIORITY_OR_OTHER||LS mean difference|-37.6|STANDARD_ERROR_OF_MEAN|1.77|<|0.001|TWO_SIDED|95.0|-41.1|-34.1|||MMRM|||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-34.1|-41.1|<0.001
71104938|NCT01968980|141717014|SUPERIORITY_OR_OTHER||LS mean difference|-51.0|STANDARD_ERROR_OF_MEAN|2.36|<|0.001|TWO_SIDED|95.0|-55.7|-46.4|||MMRM|||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-46.4|-55.7|<0.001
71104939|NCT01968980|141717015|SUPERIORITY_OR_OTHER||LS mean difference|-48.0|STANDARD_ERROR_OF_MEAN|2.44|<|0.001|TWO_SIDED|95.0|-52.8|-43.2|||MMRM|||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-43.2|-52.8|<0.001
71104940|NCT01968980|141717016|SUPERIORITY_OR_OTHER||LS mean difference|-28.6|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|-33.9|-23.2|||MMRM|||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-23.2|-33.9|<0.001
71104941|NCT01968980|141717017|SUPERIORITY_OR_OTHER||LS mean difference|7.0|STANDARD_ERROR_OF_MEAN|1.47|<|0.001|TWO_SIDED|95.0|4.1|9.9|||MMRM|||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||9.9|4.1|<0.001
71104942|NCT01968980|141717018|SUPERIORITY_OR_OTHER||LS mean difference|-52.1|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-58.2|-46.0||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-46.0|-58.2|
71104943|NCT01968980|141717018|SUPERIORITY_OR_OTHER||LS mean difference|-48.0|STANDARD_ERROR_OF_MEAN|2.87|||TWO_SIDED|95.0|-53.6|-42.3||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-42.3|-53.6|
71104944|NCT01968980|141717019|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.8|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|95.0|-40.0|-31.6||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-31.6|-40.0|
71050095|NCT02504671|141606197|OTHER||Mean Difference (Net)|2.4||||0.287|TWO_SIDED|95.0|-2.03|6.84||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Mental health|||6.84|-2.03|0.287
71016387|NCT01569074|141541041|SUPERIORITY_OR_OTHER||Treatment difference|1.45||||0.481|TWO_SIDED|80.0|-1.19|4.09|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||4.09|-1.19|0.481
71016388|NCT01803464|141541042|OTHER||Cohen's d|0.59|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the Botox plus low-magnitude vibration group minus the % change of the cerebral palsy control group was the numerator. The pooled Standard Deviation (SD) of the % change for the 2 groups was the denominator.|||||
71016389|NCT01803464|141541042|OTHER||Cohen's d|0.13|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the Botox group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.|||||
71050096|NCT02504671|141606197|OTHER||Mean Difference (Net)|3.45||||0.125|TWO_SIDED|95.0|-0.96|7.85||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Mental health|||7.85|-0.96|0.125
71050097|NCT02504671|141606197|OTHER||Mean Difference (Net)|2.15||||0.503|TWO_SIDED|95.0|-4.18|8.49||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Mental health|||8.49|-4.18|0.503
71050098|NCT02504671|141606197|OTHER||Mean Difference (Net)|5.01||||0.099|TWO_SIDED|95.0|-0.96|10.98||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24,Mental health|||10.98|-0.96|0.099
71016390|NCT01803464|141541042|OTHER||Cohen's d|0.51|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the typically developing control group group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.|||||
71050099|NCT02504671|141606197|OTHER||Mean Difference (Net)|1.88||||0.268|TWO_SIDED|95.0|-1.45|5.21||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Physical functioning|||5.21|-1.45|0.268
71050100|NCT02504671|141606197|OTHER||Mean Difference (Net)|2.45||||0.147|TWO_SIDED|95.0|-0.87|5.77||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Physical functioning|||5.77|-0.87|0.147
71050101|NCT02504671|141606197|OTHER||Mean Difference (Net)|2.87||||0.145|TWO_SIDED|95.0|-0.99|6.73||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Physical functioning|||6.73|-0.99|0.145
71050102|NCT02504671|141606197|OTHER||Mean Difference (Net)|2.54||||0.014|TWO_SIDED|95.0|0.97|8.61||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Physical functioning|||8.61|0.97|0.014
71104945|NCT01968980|141717019|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.8|STANDARD_ERROR_OF_MEAN|2.02|||TWO_SIDED|95.0|-35.8|-27.8||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-27.8|-35.8|
71104946|NCT01968980|141717020|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.5|STANDARD_ERROR_OF_MEAN|2.86|||TWO_SIDED|95.0|-54.1|-42.8||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-42.8|-54.1|
71050103|NCT02504671|141606197|OTHER||Mean Difference (Net)|0.47||||0.856|TWO_SIDED|95.0|-4.66|5.61||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Physical functioning|||5.61|-4.66|0.856
71016391|NCT01803464|141541043|OTHER||Cohen's d|0.45|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the Botox plus low-magnitude vibration group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator|||||
71016392|NCT01803464|141541043|OTHER||Cohen's d|0.57|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the Botox group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.|||||
71050104|NCT02504671|141606197|OTHER||Mean Difference (Net)|0.65||||0.793|TWO_SIDED|95.0|-4.24|5.55||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Physical functioning|||5.55|-4.24|0.793
71050105|NCT02504671|141606197|OTHER||Mean Difference (Net)|0.59||||0.778|TWO_SIDED|95.0|-3.51|4.69||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Role emotional|||4.69|-3.51|0.778
71050106|NCT02504671|141606197|OTHER||Mean Difference (Net)|-0.6||||0.773|TWO_SIDED|95.0|-4.7|3.5||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Role emotional|||3.50|-4.70|0.773
71050107|NCT02504671|141606197|OTHER||Mean Difference (Net)|1.08||||0.631|TWO_SIDED|95.0|-3.34|5.49||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Role emotional|||5.49|-3.34|0.631
71050108|NCT02504671|141606197|OTHER||Mean Difference (Net)|2.68||||0.23|TWO_SIDED|95.0|-1.71|7.07||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Role emotional|||7.07|-1.71|0.230
71050109|NCT02504671|141606197|OTHER||Mean Difference (Net)|0.41||||0.901|TWO_SIDED|95.0|-6.03|6.84||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Role emotional|||6.84|-6.03|0.901
71050110|NCT02504671|141606197|OTHER||Mean Difference (Net)|2.52||||0.412|TWO_SIDED|95.0|-3.54|8.59||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Role emotional|||8.59|-3.54|0.412
71050111|NCT02504671|141606197|OTHER||Mean Difference (Net)|1.88||||0.234|TWO_SIDED|95.0|-1.22|4.98||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Role physical|||4.98|-1.22|0.234
71016393|NCT01803464|141541043|OTHER||Cohen's d|0.13|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the typically developing group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator|||||
71016394|NCT01803464|141541044|OTHER||Cohen's d|1.2|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the Botox plus low-magnitude vibration group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.|||||
71016395|NCT01803464|141541044|OTHER||Cohen's d|0.33|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the Botox group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.|||||
71016396|NCT01803464|141541044|OTHER||Cohen's d|0.33|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the typically developing control group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.|||||
71016397|NCT02424851|141541045|OTHER|||||||0.006|||||||Fisher Exact|||||||0.006
71016398|NCT02424851|141541046|OTHER|||||||0.02|||||||Fisher Exact|||||||0.02
71016399|NCT02424851|141541047|OTHER||||||=|0.48|||||||Fisher Exact|||Statistical analysis of SAEs.||||=0.48
71050112|NCT02504671|141606197|OTHER||Mean Difference (Net)|2.66||||0.094|TWO_SIDED|95.0|-0.46|5.77||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Role physical|||5.77|-0.46|0.094
71104947|NCT01968980|141717020|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.2|STANDARD_ERROR_OF_MEAN|2.71|||TWO_SIDED|95.0|-47.5|-36.9||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-36.9|-47.5|
71104948|NCT01968980|141717021|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.8|STANDARD_ERROR_OF_MEAN|2.67|||TWO_SIDED|95.0|-52.1|-41.6||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-41.6|-52.1|
70850713|NCT04518995|141189575|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.9|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-1.3|-1.9|<0.0001
71016400|NCT02424851|141541047|OTHER||||||=|0.25|||||||Fisher Exact|||Statistical analysis of AEs||||=0.25
71016401|NCT02424851|141541048|OTHER||||||=|0.31|||||||Log Rank|||||||= 0.31
71016402|NCT02424851|141541049|OTHER||||||=|0.45|||||||Fisher Exact|||||||=0.45
71016403|NCT02424851|141541050|OTHER|||||||0.33|||||||t-test, 1 sided|||||||0.33
71016404|NCT01360021|141541059|SUPERIORITY_OR_OTHER||Estimated Geometic Mean Ratio|1.1||||0.001|TWO_SIDED|95.0|1.06|1.14|||ANCOVA|ANCOVA model on the log transformed outcome variable with treatment and country as factor, and log transformed baseline FEV1 (pre-dose) as covariate.|Symbicort AC pMDI 2x160/4.5 µg bid vs Budesonide AC pMDI 2x160 µg bid|The comparison of Symbicort AC pMDI 2x160/4.5 µg bid with budesonide AC pMDI 2x160 µg bid for post dose FEV1||1.14|1.06|0.001
71016405|NCT01360021|141541059|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a standard deviation of 0.2 (for pre dose FEV1) on the log-scale and 60 patients/arm, the width of the confidence interval will extend 0.072 from the point estimate on the log-scale. The lower and upper limits of the CI for the ratio of effects will thus be obtained by multiplying the estimated ratio by 0.931 and 1.075, respectively.|Estimated Geometric Mean Ratio|1.01|||||TWO_SIDED|95.0|0.97|1.05|||ANCOVA|ANCOVA model on the log transformed outcome variable with treatment and country as factor, and log transformed baseline FEV1 (pre-dose) as covariate.|The comparisons was used to assess therapeutic equivalence of Symbicort AC pMDI and Symbicort BA MDI. Assay sensitivity was demonstrated before proceeding to assess therapeutic equivalence of the 2 Symbicort products.|The comparisons of Symbicort BA MDI 2x160/4.5 µg bid with Symbicort AC pMDI 2x160/4.5 µg bid for post dose FEV1.||1.05|0.97|
71016406|NCT01360021|141541060|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a standard deviation of 0.2 (for pre dose FEV1) on the log-scale and 60 patients/arm, the width of the confidence interval will extend 0.072 from the point estimate on the log-scale. The lower and upper limits of the CI for the ratio of effects will thus be obtained by multiplying the estimated ratio by 0.931 and 1.075, respectively.|Estimated Geometric Mean Ratio|1.03|||||TWO_SIDED|95.0|0.99|1.08|||ANCOVA|ANCOVA model on the log transformed outcome variable with treatment and country as factor, and log transformed baseline FEV1 (pre-dose) as covariate.|The comparisons was used to assess therapeutic equivalence of Symbicort AC pMDI and Symbicort BA MDI. Assay sensitivity was demonstrated before proceeding to assess therapeutic equivalence of the 2 Symbicort products.|The comparisons of Symbicort BA MDI 2x160/4.5 µg bid with Symbicort AC pMDI 2x160/4.5 µg bid, for pre-dose FEV1.||1.08|0.99|
71016407|NCT01360021|141541061|NON_INFERIORITY_OR_EQUIVALENCE|No adjustment were be made for multiplicity for these supportive variables and nominal p-values were reported.|Mean Difference (Net)|1.49|STANDARD_ERROR_OF_MEAN|6.75||0.825|TWO_SIDED|95.0|-11.81|14.8|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.|Secondary efficacy variables were analyzed as continuous data, comparing mean changes from baseline to the average of the double-blind treatment period between treatments. No adjustment were made for multiplicity and nominal p-values were reported.|Morning peak expiratory flow (mPEF): Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort BA MDI 2x160/4.5 μg bid and Symbicort AC pMDI 2x160/4.5 µg bid||14.80|-11.81|0.825
71050113|NCT02504671|141606197|OTHER||Mean Difference (Net)|1.43||||0.423|TWO_SIDED|95.0|-2.08|4.94||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Role physical|||4.94|-2.08|0.423
71050114|NCT02504671|141606197|OTHER||Mean Difference (Net)|3.35||||0.061|TWO_SIDED|95.0|-0.16|6.86||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Role physical|||6.86|-0.16|0.061
71050115|NCT02504671|141606197|OTHER||Mean Difference (Net)|1.21||||0.657|TWO_SIDED|95.0|-4.16|6.57||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Role physical|||6.57|-4.16|0.657
70850714|NCT04518995|141189575|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.8|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.2|-1.8|<0.0001
71016408|NCT01360021|141541061|SUPERIORITY_OR_OTHER||Mean Difference (Net)|33.52|STANDARD_ERROR_OF_MEAN|6.8||0.001|TWO_SIDED|95.0|20.11|46.93|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.|Secondary efficacy variables were analyzed as continuous data, comparing mean changes from baseline to the average of the double-blind treatment period between treatments. No adjustment were made for multiplicity and nominal p-values were reported.|Morning peak expiratory flow (mPEF): Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort AC pMDI 2x160/4.5 µg bid minus Budesonide AC pMDI 2x160 µg bid||46.93|20.11|0.001
71016409|NCT01360021|141541061|NON_INFERIORITY_OR_EQUIVALENCE|No adjustment were made for multiplicity for these supportive variables and nominal p-values were reported.|Mean Difference (Net)|1.48|STANDARD_ERROR_OF_MEAN|6.15||0.81|TWO_SIDED|95.0|-10.66|13.61|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.|Secondary efficacy variables were analyzed as continuous data, comparing mean changes from baseline to the average of the double-blind treatment period between treatments. No adjustment were made for multiplicity and nominal p-values were reported.|Evening peak expiratory flow (ePEF): Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort BA MDI 2x160/4.5 μg bid and Symbicort AC pMDI 2x160/4.5 µg bid.||13.61|-10.66|0.810
71104949|NCT01968980|141717021|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.5|STANDARD_ERROR_OF_MEAN|2.53|||TWO_SIDED|95.0|-45.5|-35.5||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-35.5|-45.5|
71104950|NCT01968980|141717022|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.1|STANDARD_ERROR_OF_MEAN|12.58|||TWO_SIDED|95.0|-59.8|-10.3||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-10.3|-59.8|
71016410|NCT01360021|141541061|SUPERIORITY_OR_OTHER||Mean Difference (Net)|32.25|STANDARD_ERROR_OF_MEAN|6.21||0.001|TWO_SIDED|95.0|20.01|44.49|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.|Secondary efficacy variables were analyzed as continuous data, comparing mean changes from baseline to the average of the double-blind treatment period between treatments. No adjustment were made for multiplicity and nominal p-values were reported.|Evening peak expiratory flow (ePEF): Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort AC pMDI 2x160/4.5 µg bid and Budesonide AC pMDI 2x160 µg bid.||44.49|20.01|0.001
71016411|NCT01360021|141541062|NON_INFERIORITY_OR_EQUIVALENCE|No adjustment were made for multiplicity for these supportive variables and nominal p-values were reported.|Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.11||0.272|TWO_SIDED|95.0|-0.1|0.35|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.||Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort BA MDI 2x160/4.5 μg bid and Symbicort AC pMDI 2x160/4.5 µg bid.||0.35|-0.10|0.272
71016412|NCT01360021|141541063|NON_INFERIORITY_OR_EQUIVALENCE|No adjustment were made for multiplicity for these supportive variables and nominal p-values were reported.|Mean Difference (Net)|-6.1|STANDARD_ERROR_OF_MEAN|2.69||0.025|TWO_SIDED|95.0|-11.41|-0.79|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.||Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort BA MDI 2x160/4.5 μg bid and Symbicort AC pMDI 2x160/4.5 µg bid.||-0.79|-11.41|0.025
71016413|NCT01360021|141541064|NON_INFERIORITY_OR_EQUIVALENCE|No adjustment were made for multiplicity for these supportive variables and nominal p-values were reported.|Mean Difference (Net)|0.26|STANDARD_ERROR_OF_MEAN|0.23||0.258|TWO_SIDED|95.0|-0.19|0.71|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.||Comparing mean changes from baseline to the average of the double-blind treatment period between BAI Symbicort BA MDI 2x160/4.5 μg bid and pMDI Symbicort AC pMDI 2x160/4.5 µg bid.||0.71|-0.19|0.258
71016414|NCT02446496|141541065|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Point estimate percent|95.91|||||TWO_SIDED|90.0|85.67|107.37||||||||107.37|85.67|
71016415|NCT02446496|141541066|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Point estimate percent|102.31|||||TWO_SIDED|90.0|90.46|115.7|||||Comparison of AUC (0-t) between Treatment A and Treatment B|||115.70|90.46|
71016416|NCT02446496|141541066|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Point estimate percent|103.13|||||TWO_SIDED|90.0|91.19|116.62|||||Comparison of AUC(0-infinity) between Treatment A and Treatment B|||116.62|91.19|
71016417|NCT02446496|141541067|SUPERIORITY_OR_OTHER|||||||0.267||95.0|||||Wilcoxon's Signed-Rank Test|Comparison of T-max between Treatment A and Treatment B.||||||0.2670
71016418|NCT03170271|141541083|SUPERIORITY|The null hypothesis was that the exacerbation rate of benralizumab was equal to the exacerbation rate of placebo.|Rate ratio|0.51|||<|0.0001|TWO_SIDED|95.0|0.39|0.65|||Negative binomial|||Comparison of annual exacerbation rates for benralizumab vs placebo (rate ratio). Treatment group, region, number of exacerbations in previous year and maintenance OCS use at baseline were included in the negative binomial model as covariates. The log of each patient's corresponding follow-up time was used as an offset variable in the model to adjust for patients having different follow-up times during which events occurred.||0.65|0.39|<0.0001
71016419|NCT03170271|141541084|SUPERIORITY||LS Mean difference|-8.11|||<|0.0001|TWO_SIDED|95.0|-11.41|-4.82|||Repeated measures analysis||Model: Change from baseline in SGRQ total score = Treatment + baseline SGRQ total score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SGRQ total score at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a mixed-effect model for repeated measures (MMRM) analysis.||-4.82|-11.41|<0.0001
70850715|NCT04518995|141189575|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-2.3|-1.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.6|-2.3|<0.0001
71016420|NCT03170271|141541085|SUPERIORITY||LS Mean difference|0.16|||<|0.0001|TWO_SIDED|95.0|0.09|0.23|||Repeated measures analysis||Model: Change from baseline in pre-BD FEV1 = Treatment + baseline pre-BD FEV1 + region + number of exacerbations in previous year + maintenance OCS use at baseline + gender + age + visit + treatment by visit.|Change from baseline in pre-BD FEV1 at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||0.23|0.09|<0.0001
71016421|NCT03170271|141541086|SUPERIORITY||LS Mean difference|-0.46|||<|0.0001|TWO_SIDED|95.0|-0.65|-0.27|||Repeated measures analysis||Model: Change from baseline in ACQ-6 score = Treatment + baseline ACQ-6 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in ACQ-6 score at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||-0.27|-0.65|<0.0001
71016422|NCT03170271|141541087|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.67|||Regression, Cox||A hazard ratio \< 1 favours benralizumab to be associated with a longer time from randomization to the first exacerbation than placebo.|Comparison of time to first asthma exacerbation for benralizumab vs placebo. Treatment group, region, number of exacerbations in previous year and maintenance OCS use at baseline were included in the Cox proportional hazard model as covariates.||0.67|0.40|<0.0001
71016423|NCT03170271|141541088|SUPERIORITY||LS Mean difference|20.11||||0.0031|TWO_SIDED|95.0|6.79|33.44|||Repeated measures analysis||Model: Change from baseline in PEF = Treatment + baseline PEF + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from run-in baseline in morning PEF at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||33.44|6.79|0.0031
71016424|NCT03170271|141541088|SUPERIORITY||LS Mean Difference|23.09||||0.0008|TWO_SIDED|95.0|9.62|36.55|||Repeated measures analysis||Model: Change from baseline in PEF = Treatment + baseline PEF + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from run-in baseline in evening PEF at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||36.55|9.62|0.0008
71016425|NCT03170271|141541089|SUPERIORITY||LS Mean difference|5.35||||0.0077|TWO_SIDED|95.0|1.42|9.28|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for physical functioning at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||9.28|1.42|0.0077
71016426|NCT03170271|141541089|SUPERIORITY||LS Mean Difference|6.8||||0.0022|TWO_SIDED|95.0|2.45|11.14|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for role limitations due to physical health at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||11.14|2.45|0.0022
71016427|NCT03170271|141541089|SUPERIORITY||LS Mean Difference|3.07||||0.1741|TWO_SIDED|95.0|-1.36|7.5|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for bodily pain at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||7.50|-1.36|0.1741
71050116|NCT02504671|141606197|OTHER||Mean Difference (Net)|0.87||||0.737|TWO_SIDED|95.0|-4.22|5.95||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Role physical|||5.95|-4.22|0.737
71050117|NCT02504671|141606197|OTHER||Mean Difference (Net)|2.95||||0.165|TWO_SIDED|95.0|-1.22|7.11||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Social Functioning|||7.11|-1.22|0.165
71050118|NCT02504671|141606197|OTHER||Mean Difference (Net)|3.4||||0.109|TWO_SIDED|95.0|-0.77|7.56||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Social Functioning|||7.56|-0.77|0.109
71050119|NCT02504671|141606197|OTHER||Mean Difference (Net)|1.98||||0.359|TWO_SIDED|95.0|-2.26|6.21||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Social Functioning|||6.21|-2.26|0.359
71050120|NCT02504671|141606197|OTHER||Mean Difference (Net)|4.35||||0.043|TWO_SIDED|95.0|0.14|8.56||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Social Functioning|||8.56|0.14|0.043
71050121|NCT02504671|141606197|OTHER||Mean Difference (Net)|-0.33||||0.923|TWO_SIDED|95.0|-7.15|6.49||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Social Functioning|||6.49|-7.15|0.923
71050122|NCT02504671|141606197|OTHER||Mean Difference (Net)|0.3||||0.927|TWO_SIDED|95.0|-6.11|6.7||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Social Functioning|||6.70|-6.11|0.927
71050123|NCT02504671|141606197|OTHER||Mean Difference (Net)|4.64||||0.018|TWO_SIDED|95.0|0.82|8.46||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Vitality|||8.46|0.82|0.018
71050124|NCT02504671|141606197|OTHER||Mean Difference (Net)|3.34||||0.087|TWO_SIDED|95.0|-0.49|7.17||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Vitality|||7.17|-0.49|0.087
71050125|NCT02504671|141606197|OTHER||Mean Difference (Net)|2.64||||0.193|TWO_SIDED|95.0|-1.35|6.64||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Vitality|||6.64|-1.35|0.193
70850716|NCT04518995|141189575|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-2.0|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.3|-2.0|<0.0001
71016428|NCT03170271|141541089|SUPERIORITY||LS Mean Difference|5.62||||0.0009|TWO_SIDED|95.0|2.32|8.92|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for general health perceptions at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||8.92|2.32|0.0009
71016429|NCT03170271|141541089|SUPERIORITY||LS Mean Difference|5.51||||0.0025|TWO_SIDED|95.0|1.95|9.08|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for vitality at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||9.08|1.95|0.0025
71016430|NCT03170271|141541089|SUPERIORITY||LS Mean Difference|3.12||||0.1583|TWO_SIDED|95.0|-1.22|7.46|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for social functioning at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||7.46|-1.22|0.1583
71016431|NCT03170271|141541089|SUPERIORITY||LS Mean Difference|2.44||||0.2103|TWO_SIDED|95.0|-1.38|6.27|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for role limitations due to emotional problems at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||6.27|-1.38|0.2103
71016432|NCT03170271|141541089|SUPERIORITY||LS Mean Difference|1.68||||0.2581|TWO_SIDED|95.0|-1.23|4.59|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for mental health at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||4.59|-1.23|0.2581
71016433|NCT03170271|141541089|SUPERIORITY||LS Mean Difference|2.32||||0.0022|TWO_SIDED|95.0|0.84|3.81|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 physical health component summary score at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||3.81|0.84|0.0022
71016434|NCT03170271|141541089|SUPERIORITY||LS Mean Difference|0.87||||0.2751|TWO_SIDED|95.0|-0.7|2.44|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 mental health component summary score at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||2.44|-0.70|0.2751
71016435|NCT03170271|141541090|SUPERIORITY||Odds Ratio (OR)|1.55||||0.0233|TWO_SIDED|95.0|1.06|2.25|||Regression, Logistic||Model: ln (1/(1-p)) = Treatment + baseline score + region + number of exacerbations in previous year + maintenance OCS use at baseline, where p is the proportion of patients being a responder.|Estimate of the log odds of being a responder classified as type 'Improvement' at Week 24 in the benralizumab group compared to the placebo group using a logistic regression.||2.25|1.06|0.0233
71050126|NCT02504671|141606197|OTHER||Mean Difference (Net)|3.97||||0.051|TWO_SIDED|95.0|-0.01|7.95||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Vitality|||7.95|-0.01|0.051
71050127|NCT02504671|141606197|OTHER||Mean Difference (Net)|3.36||||0.321|TWO_SIDED|95.0|-3.31|10.02||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Vitality|||10.02|-3.31|0.321
71050128|NCT02504671|141606197|OTHER||Mean Difference (Net)|3.13||||0.328|TWO_SIDED|95.0|-3.18|9.44||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Vitality|||9.44|-3.18|0.328
71050129|NCT02504671|141606198|OTHER||Mean Difference (Net)|-0.65||||0.701|TWO_SIDED|95.0|-3.97|2.67||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, FACIT score|||2.67|-3.97|0.701
71050130|NCT02504671|141606198|OTHER||Mean Difference (Net)|1.5||||0.37|TWO_SIDED|95.0|-1.79|4.78||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, FACIT score|||4.78|-1.79|0.370
71104951|NCT01968980|141717022|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.3|STANDARD_ERROR_OF_MEAN|5.58|||TWO_SIDED|95.0|-26.3|-4.4||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-4.4|-26.3|
71050131|NCT02504671|141606198|OTHER||Mean Difference (Net)|2.55||||0.125|TWO_SIDED|95.0|-0.71|5.81||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, FACIT score|||5.81|-0.71|0.125
71050132|NCT02504671|141606198|OTHER||Mean Difference (Net)|1.92||||0.292|TWO_SIDED|95.0|-1.66|5.5||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, FACIT score|||5.50|-1.66|0.292
71050133|NCT02504671|141606198|OTHER||Mean Difference (Net)|6.11||||0.163|TWO_SIDED|95.0|-1.04|6.11||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, FACIT sscore|||6.11|-1.04|0.163
71016436|NCT03170271|141541090|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0401|TWO_SIDED|95.0|1.02|2.16|||Regression, Logistic||Model: ln (1/(1-p)) = Treatment + baseline score + region + number of exacerbations in previous year + maintenance OCS use at baseline, where p is the proportion of patients being a responder.|Estimate of the log odds of being a responder classified as type 'Important Improvement' at Week 24 in the benralizumab group compared to the placebo group using a logistic regression.||2.16|1.02|0.0401
71016437|NCT03170271|141541091|SUPERIORITY||Odds Ratio (OR)|2.05|||<|0.0001|TWO_SIDED|95.0|1.47|2.86|||Regression, Logistic||Model: ln (1/(1-p)) = Treatment + region + number of exacerbations in previous year + maintenance OCS use at baseline, where p is the proportion of patients being a responder.|Estimate of the log odds of being a CGI-C responder classified as type 'Much improved' at Week 24 in the benralizumab group compared to the placebo group using a logistic regression.||2.86|1.47|<0.0001
71016438|NCT03170271|141541091|SUPERIORITY||Odds Ratio (OR)|3.45||||0.0003|TWO_SIDED|95.0|1.77|6.7|||Regression, Logistic||Model: ln (1/(1-p)) = Treatment + region + number of exacerbations in previous year + maintenance OCS use at baseline, where p is the proportion of patients being a responder.|Estimate of the log odds of being a CGI-C responder classified as type 'Very much improved' at Week 24 in the benralizumab group compared to the placebo group using a logistic regression.||6.70|1.77|0.0003
71050134|NCT02504671|141606198|OTHER||Mean Difference (Net)|3.08||||0.087|TWO_SIDED|95.0|-0.46|6.61||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, FACIT score|||6.61|-0.46|0.087
71050135|NCT02504671|141606198|OTHER||Mean Difference (Net)|0.76||||0.808|TWO_SIDED|95.0|-5.4|6.92||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, FACIT score|||6.92|-5.40|0.808
70930455|NCT05257603|141359343|OTHER||||||<|0.1||||||A priori threshold for a trend set at p\<.10 for condition effect (intervention v control).|ANOVA|||An exploratory repeated measures ANOVA with time (4) as the within-subjects variable and condition (2) as the between-subjects variable was conducted to provide preliminary information for estimating sample sizes needed for a larger Stage II efficacy trial. The current pilot RCT was not powered to find significant effects.||||<.10
71050136|NCT02504671|141606198|OTHER||Mean Difference (Net)|-0.47||||0.874|TWO_SIDED|95.0|-6.31|5.38||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, FACIT score|||5.38|-6.31|0.874
71050137|NCT02504671|141606198|OTHER||Mean Difference (Net)|-0.81||||0.78|TWO_SIDED|95.0|-6.58|4.95||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,FACIT score|||4.95|-6.58|0.780
71050138|NCT02504671|141606198|OTHER||Mean Difference (Net)|3.57||||0.033|TWO_SIDED|95.0|0.29|6.85||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, FACIT score|||6.85|0.29|0.033
71016439|NCT03170271|141541091|SUPERIORITY||Odds Ratio (OR)|2.06|||<|0.0001|TWO_SIDED|95.0|1.48|2.87|||Regression, Logistic||Model: ln (1/(1-p)) = Treatment + region + number of exacerbations in previous year + maintenance OCS use at baseline, where p is the proportion of patients being a responder.|Estimate of the log odds of being a PGI-C responder classified as type 'Much improved' at Week 24 in the benralizumab group compared to the placebo group using a logistic regression.||2.87|1.48|<0.0001
71016440|NCT03170271|141541091|SUPERIORITY||Odds Ratio (OR)|3.02|||<|0.0001|TWO_SIDED|95.0|2.02|4.51|||Regression, Logistic||Model: ln (1/(1-p)) = Treatment + region + number of exacerbations in previous year + maintenance OCS use at baseline, where p is the proportion of patients being a responder.|Estimate of the log odds of being a PGI-C responder classified as type 'Very much improved' at Week 24 in the benralizumab group compared to the placebo group using a logistic regression.||4.51|2.02|<0.0001
71016441|NCT03170271|141541092|SUPERIORITY||LS Mean difference|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.62|-0.68|||Repeated measures analysis||Model: Change from baseline in average PSIA score (top 3 ranked) =Treatment + baseline average PSIA score (top 3 ranked) + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in PSIA severity score for the average of top 3 ranked symptoms/impairments at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||-0.68|-1.62|<0.0001
71016442|NCT03170271|141541092|SUPERIORITY||LS Mean difference|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.64|-0.66|||Repeated measures analysis||Model: Change from baseline in PSIA score (top ranked) =Treatment + baseline PSIA score (top ranked) + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in PSIA severity score of top ranked symptom/impairment at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||-0.66|-1.64|<0.0001
71016443|NCT03170271|141541093|SUPERIORITY||LS Mean difference|-8.91||||0.0204|TWO_SIDED|95.0|-16.42|-1.4|||Repeated measures analysis||Model: Change from baseline in SNOT-22 total score = Treatment + baseline SNOT-22 total score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SNOT-22 total score at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||-1.40|-16.42|0.0204
71016444|NCT01984229|141541143|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|118.0|||||TWO_SIDED|90.0|102.0|137.0|||||The reported values are percentages of geometric least square mean ratio.|Analysis of variance (ANOVA) was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and confidence intervals (CIs).||137|102|
71016445|NCT01984229|141541144|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|177.0|||||TWO_SIDED|90.0|159.0|198.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and CIs.||198|159|
71016446|NCT01984229|141541145|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|175.0|||||TWO_SIDED|90.0|157.0|195.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and CIs.||195|157|
71016447|NCT01984229|141541149|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|28.7|||||TWO_SIDED|90.0|23.1|35.5|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and CIs.||35.5|23.1|
71050139|NCT02504671|141606198|OTHER||Mean Difference (Net)|2.81||||0.094|TWO_SIDED|95.0|-0.48|6.1||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, FACIT score|||6.10|-0.48|0.094
71050140|NCT02504671|141606198|OTHER||Mean Difference (Net)|3.92||||0.032|TWO_SIDED|95.0|0.34|7.49||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, FACIT score|||7.49|0.34|0.032
70850717|NCT04518995|141189575|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-2.5|-1.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.7|-2.5|<0.0001
70850718|NCT04518995|141189576|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-0.9|-0.3||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-0.3|-0.9|<0.0001
71050141|NCT02504671|141606198|OTHER||Mean Difference (Net)|5.33||||0.004|TWO_SIDED|95.0|1.77|8.89||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, FACIT score|||8.89|1.77|0.004
71050142|NCT02504671|141606198|OTHER||Mean Difference (Net)|0.73||||0.808|TWO_SIDED|95.0|-5.19|6.64||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, FACIT score|||6.64|-5.19|0.808
70930456|NCT05257603|141359344|OTHER||||||<|0.098|||||||ANOVA|||An exploratory repeated measures ANOVA with time (4) as the within-subjects variable and condition (2) as the between-subjects variable was conducted to provide preliminary information for estimating sample sizes needed for a larger Stage II efficacy trial.||||<.098
71050143|NCT02504671|141606198|OTHER||Mean Difference (Net)|1.87||||0.511|TWO_SIDED|95.0|-3.74|7.48||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, FACIT score|||7.48|-3.74|0.511
70930457|NCT04024059|141359352|SUPERIORITY||Odds Ratio (OR)|1.737|||=|0.22|TWO_SIDED|95.0|0.719|4.195|||Regression, Logistic|||||4.195|0.719|=0.22
71016448|NCT01984229|141541150|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|66.2|||||TWO_SIDED|90.0|56.7|77.4|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and CIs.||77.4|56.7|
71016449|NCT01984229|141541151|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|75.1|||||TWO_SIDED|90.0|64.4|87.7|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and CIs.||87.7|64.4|
71016450|NCT02325739|141541162|OTHER||RP2D|120.0|||||||||||||The estimation parameter and recommended Phase 2 dose level for FGF401 (single agent - fasted) is 120mg.|||||
71016451|NCT02325739|141541162|OTHER||RP2D|120.0|||||||||||||The estimation parameter and recommended Phase 2 dose level for FGF401 (single agent - fed) is 120mg.|||||
71016452|NCT02325739|141541162|OTHER||RP2D|120.0|||||||||||||The estimation parameter and recommended Phase 2 dose level for FGF401 + PDR001 combination is for FGF401 120mg.|||||
71016453|NCT02325739|141541162|OTHER||RP2D|300.0|||||||||||||The estimation parameter and recommended Phase 2 dose level for FGF401 + PDR001 combination is for PDR001 300mg.|||||
71016454|NCT03728257|141541197|SUPERIORITY|Change in average steps per day between baseline and 3 months was compared between the two groups.||||||0.8793||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.8793
71016455|NCT03728257|141541198|SUPERIORITY|Change in average steps per day between baseline and 6 months was compared between the two groups.||||||0.9597||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.9597
71050144|NCT02504671|141606199|OTHER||Mean Difference (Net)|-0.07||||0.888|TWO_SIDED|95.0|-1.04|0.9||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, BFI score|||0.90|-1.04|0.888
71050145|NCT02504671|141606199|OTHER||Mean Difference (Net)|-0.5||||0.307|TWO_SIDED|95.0|-1.46|0.46||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, BFI score|||0.46|-1.46|0.307
71050146|NCT02504671|141606199|OTHER||Mean Difference (Net)|-0.99||||0.041|TWO_SIDED|95.0|-1.95|-0.04||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, BFI score|||-0.04|-1.95|0.041
71050147|NCT02504671|141606199|OTHER||Mean Difference (Net)|-0.64||||0.191|TWO_SIDED|95.0|-1.6|0.32||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, BFI score|||0.32|-1.60|0.191
71050148|NCT02504671|141606199|OTHER||Mean Difference (Net)|-1.2||||0.014|TWO_SIDED|95.0|-2.16|-0.24||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, BFI score|||-0.24|-2.16|0.014
71050149|NCT02504671|141606199|OTHER||Mean Difference (Net)|-1.39||||0.004|TWO_SIDED|95.0|-2.34|-0.45||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, BFI score|||-0.45|-2.34|0.004
71050150|NCT02504671|141606199|OTHER||Mean Difference (Net)|-0.36||||0.656|TWO_SIDED|95.0|-1.94|1.23||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, BFI score|||1.23|-1.94|0.656
71050151|NCT02504671|141606199|OTHER||Mean Difference (Net)|0.07||||0.928|TWO_SIDED|95.0|-1.43|1.57||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, BFI score|||1.57|-1.43|0.928
70930458|NCT04024059|141359352|SUPERIORITY||Odds Ratio (OR)|1.035|||=|0.938|TWO_SIDED|95.0|0.435|2.461|||Regression, Logistic|||||2.461|0.435|=0.938
70930459|NCT04024059|141359353|SUPERIORITY||Odds Ratio (OR)|1.783|||=|0.202|TWO_SIDED|95.0|0.733|4.336|||Regression, Logistic|||||4.336|0.733|=0.202
70930460|NCT04024059|141359353|SUPERIORITY||Odds Ratio (OR)|1.38|||=|0.474|TWO_SIDED|95.0|0.571|3.336|||Regression, Logistic|||||3.336|0.571|=.474
71016456|NCT03728257|141541199|SUPERIORITY|Change in Berg balance between baseline and 3 months was compared between the two groups.||||||0.3||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.30
71016457|NCT03728257|141541200|SUPERIORITY|Change in Berg balance between baseline and 3 months was compared between the two groups.||||||0.81||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.81
71016458|NCT03728257|141541201|SUPERIORITY|Change in 30 Second Sit-to-Stand Test between baseline and 3 months was compared between the two groups.||||||0.2262||||||a priori threshold for statistical significance is p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.2262
71016459|NCT03728257|141541202|SUPERIORITY|Change in 30 Second Sit-to-Stand Test between baseline and 6 months was compared between the two groups.||||||0.59||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.59
71050152|NCT02504671|141606199|OTHER||Mean Difference (Net)|-0.2||||0.788|TWO_SIDED|95.0|-1.68|1.28||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, BFI score|||1.28|-1.68|0.788
71050153|NCT02504671|141606199|OTHER||Mean Difference (Net)|-1.26||||0.01|TWO_SIDED|95.0|-2.22|-0.3||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, BFI score|||-0.30|-2.22|0.010
71050154|NCT02504671|141606199|OTHER||Mean Difference (Net)|-0.93||||0.059|TWO_SIDED|95.0|-1.89|0.03||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, BFI score|||0.03|-1.89|0.059
71050155|NCT02504671|141606199|OTHER||Mean Difference (Net)|-1.44||||0.003|TWO_SIDED|95.0|-2.4|-0.48||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, BFI score|||-0.48|-2.40|0.003
71050156|NCT02504671|141606199|OTHER||Mean Difference (Net)|-1.57||||0.001|TWO_SIDED|95.0|-2.53|-0.62||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, BFI score|||-0.62|-2.53|0.001
70930461|NCT04024059|141359354|SUPERIORITY||Odds Ratio (OR)|0.669|||=|0.328|TWO_SIDED|95.0|0.299|1.497|||Regression, Logistic|||||1.497|0.299|=0.328
71050157|NCT02504671|141606199|OTHER||Mean Difference (Net)|-0.76||||0.324|TWO_SIDED|95.0|-2.28|0.76||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, BFI score|||0.76|-2.28|0.324
71050158|NCT02504671|141606199|OTHER||Mean Difference (Net)|-0.58||||0.432|TWO_SIDED|95.0|-2.02|0.87||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, BFI score|||0.87|-2.02|0.432
70930462|NCT04024059|141359354|SUPERIORITY||Odds Ratio (OR)|0.724|||=|0.435|TWO_SIDED|95.0|0.322|1.627|||Regression, Logistic|||||1.627|0.322|=0.435
71050159|NCT01687478|141606218|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.62|||||TWO_SIDED|95.0|-5.04|1.8|||||The Confidence Interval is based on the treatment difference LS Mean changes from baseline between Olanzapine + Fluoxetine and Placebo + Fluoxetine.|||1.80|-5.04|
71077876|NCT02913105|141664398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.151|TWO_SIDED|90.0|0.91|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 14||1.01|0.91|0.1510
70930463|NCT02911805|141359374|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70930464|NCT05954546|141359377|OTHER||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.62|1.72|||||Hazard ratio (HR) was estimated using multivariable Cox proportional hazard models.|Statistical analysis data is presented for Encorafenib+Binimetinib (RWD) relative to Encorafenib+Binimetinib (CTD) (reference).||1.72|0.62|
70930465|NCT02624050|141359384|SUPERIORITY||Risk Ratio (RR)|1.0||||0.01|TWO_SIDED|||||Threshold for significance was p\<0.05.|log-binomial regression|||||||0.01
70930466|NCT02624050|141359385|SUPERIORITY||Risk Ratio (RR)|1.0||||0.37|TWO_SIDED|||||Threshold of significance was \<0.05|log binomial regression|||||||0.37
71016460|NCT03728257|141541203|SUPERIORITY|Change in SGRQ between baseline and 3 months was compared between the two groups.||||||0.26||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.26
71016461|NCT03728257|141541204|SUPERIORITY|Change in SGRQ between baseline and 6 months was compared between the two groups.||||||0.78||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.78
71016462|NCT03728257|141541205|SUPERIORITY|Change in MVPA between baseline and 3 months was compared between the two groups.||||||0.7073||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.7073
71016463|NCT03728257|141541206|SUPERIORITY|Change in MVPA between baseline and 6 months was compared between the two groups.||||||0.313||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.313
71016464|NCT03728257|141541207|SUPERIORITY|Change in count of participants with the same or improved stage of hypertension between baseline and 6 months.||||||0.91||||||a priori threshold for statistical significance p \< 0.05|Chi-squared|||||||0.91
71016465|NCT03728257|141541208|SUPERIORITY|Change in count of participants with the same or improved stage of hypertension between baseline and 6 months.||||||0.72||||||a priori threshold of statistical significance p \< 0.05|Chi-squared|||||||0.72
71016466|NCT02044094|141541369|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|3.656|STANDARD_ERROR_OF_MEAN|1.85|||TWO_SIDED|95.0|-0.032|7.344|||||Hydromorphone - Placebo|"Week 1~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||7.344|-0.032|
71016467|NCT02044094|141541369|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|6.927|STANDARD_ERROR_OF_MEAN|1.848|||TWO_SIDED|95.0|3.243|10.612|||||Hydromorphone - Placebo|Week 1 Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05.||10.612|3.243|
71016468|NCT02044094|141541369|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|0.586|STANDARD_ERROR_OF_MEAN|1.283|||TWO_SIDED|95.0|-1.977|3.149|||||Hydromorphone - Placebo|"Week 2~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||3.149|-1.977|
71016469|NCT02044094|141541369|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|2.899|STANDARD_ERROR_OF_MEAN|1.285|||TWO_SIDED|95.0|0.333|5.465|||||Hydromorphone - Placebo|"Week 2~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||5.465|0.333|
71016470|NCT02044094|141541369|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|0.863|STANDARD_ERROR_OF_MEAN|1.959|||TWO_SIDED|95.0|-3.053|4.778|||||Hydromorphone - Placebo|"Week 3~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||4.778|-3.053|
71016471|NCT02044094|141541369|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|4.926|STANDARD_ERROR_OF_MEAN|1.956|||TWO_SIDED|95.0|1.016|8.837|||||Hydromorphone - Placebo|"Week 3~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||8.837|1.016|
70930467|NCT02624050|141359390|SUPERIORITY|||||||0.277||||||"Because the data were skewed, the natural logarithmic transformation was used prior to analysis for inference.~Threshold for statistical significance was \<0.05"|Ratio of Geometric Means|This p-value is for 15 min after induction of anesthesia||||||0.277
71050160|NCT00667810|141606259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.83||||0.057|TWO_SIDED|95.0|-3.71|0.05||The p-value is not adjusted for multiple comparison. The Hochberg approach is used to control for multiplicity between the two dose levels (0.5 mg/kg and 1.0 mg/kg) of bapineuzumab.|Mixed Models Analysis|||Change from baseline in ADAS-Cog/11 total score was analyzed using a restricted maximum likelihood (REML) based mixed model for repeated-measures (MMRM). The number of participants in each group provided approximately 90% power to detect a 2.65 point advantage at Week 78. This calculation was based on a 2-sided test with alpha set at 0.05, the use of the Hochberg procedure to control for multiplicity.||0.05|-3.71|0.057
71050161|NCT00667810|141606259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.848|TWO_SIDED|95.0|-1.73|2.1||The p-value is not adjusted for multiple comparison. The Hochberg approach is used to control for multiplicity between the two dose levels (0.5 mg/kg and 1.0 mg/kg) of bapineuzumab.|Mixed Models Analysis|||Change from baseline in ADAS-Cog/11 total score was analyzed using a REML based MMRM. The number of participants in each group provided approximately 90% power to detect a 2.65 point advantage at Week 78. This calculation was based on a 2-sided test with alpha set at 0.05, the use of the Hochberg procedure to control for multiplicity.||2.10|-1.73|0.848
71050162|NCT00667810|141606260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51||||0.459|TWO_SIDED|95.0|-2.48|5.49||The p-value is not adjusted for multiple comparison. The Hochberg approach is used to control for multiplicity between the two dose levels (0.5 mg/kg and 1.0 mg/kg) of bapineuzumab.|Mixed Models Analysis|||Change from baseline in DAD total score was analyzed using a REML based MMRM. The number of participants in each group provided approximately 90% power to detect a 6.56 point advantage at Week 78. This calculation was based on a 2-sided test with alpha set at 0.05, the use of the Hochberg procedure to control for multiplicity.||5.49|-2.48|0.459
71050163|NCT00667810|141606260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01||||0.623|TWO_SIDED|95.0|-3.04|5.07||The p-value is not adjusted for multiple comparison. The Hochberg approach is used to control for multiplicity between the two dose levels (0.5 mg/kg and 1.0 mg/kg) of bapineuzumab.|Mixed Models Analysis|||Change from baseline in DAD total score was analyzed using a REML based MMRM. The number of participants in each group provided approximately 90% power to detect a 6.56 point advantage at Week 78. This calculation was based on a 2-sided test with alpha set at 0.05, the use of the Hochberg procedure to control for multiplicity.||5.07|-3.04|0.623
71050164|NCT00667810|141606261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.654|TWO_SIDED|95.0|-0.15|0.09|||Mixed Models Analysis|||The analysis is based on the pooled bapineuzumab (with subjects in the bapineuzumab 0.5 and 1.0 mg/kg groups combined) treatment difference estimated at Week 71. The number of participants gave 90% power to detect a 0.186 unit advantage for a bapineuzumab dose group over placebo for PiB PET binding at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05 and the use of the Hochberg procedure to control for multiplicity for 2 individual doses.||0.09|-0.15|0.654
71050165|NCT00667810|141606262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.18||||0.085|TWO_SIDED|95.0|-15.38|1.02|||ANCOVA|||The analysis is based on the pooled bapineuzumab (with subjects in the bapineuzumab 0.5 and 1.0 mg/kg groups combined) treatment difference estimated at Week 71. The number of participants gave 90% power to detect a 15 ng/L advantage in p-tau for a bapineuzumab dose group over placebo at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05 and the use of the Hochberg procedure to control for multiplicity for 2 individual doses.||1.02|-15.38|0.085
71050166|NCT00667810|141606263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01||||0.437|TWO_SIDED|95.0|-1.55|3.57|||Mixed Models Analysis|||Change in MRI BBSI was analyzed using a REML based MMRM. The number of participants gave 90% power to detect a 5.05-cm3 advantage for a bapineuzumab dose group over placebo on reduction in brain volume as measured by the BBSI at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05 and the use of the Hochberg procedure to control for multiplicity for 2 individual doses.||3.57|-1.55|0.437
71050167|NCT00667810|141606263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06||||0.423|TWO_SIDED|95.0|-1.54|3.66|||Mixed Models Analysis|||Change in MRI BBSI was analyzed using a REML based MMRM. The number of participants gave 90% power to detect a 5.05-cm3 advantage for a bapineuzumab dose group over placebo on reduction in brain volume as measured by the BBSI at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05 and the use of the Hochberg procedure to control for multiplicity for 2 individual doses.||3.66|-1.54|0.423
71050168|NCT00667810|141606264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32||||0.212|TWO_SIDED|95.0|-3.4|0.76|||Mixed Models Analysis|||||0.76|-3.40|0.212
70930468|NCT05215054|141359395|NON_INFERIORITY|Non-inferiority will be demonstrated if the upper limit of the two-sided 95%CI of the difference of changes from baseline between test device and control is inferior or equal to 0.5.||||||||||||||||Difference of changes from baseline in WSRS score for Gana V versus Sculptra|Non-inferiority will be demonstrated if the upper limit of the two-sided 95%CI of the difference of changes from baseline between test device and control is inferior or equal to 0.5.To assess assay sensitivity, the proportion of responders with Gana V®, defined as improvement of ≥1-grade in the WSRS when compared to D0 pre-injection must be ≥50% at the 6 months visit after baseline.|||
70930469|NCT00626795|141359415|NON_INFERIORITY|The lower confidence limit greater or equal to -12.5% indicates non-inferiority.|Difference in percentage|4.56|||||TWO_SIDED|95.0|-1.59|10.71|||||Estimated using a Cochran-Mantel-Haenszel approach, stratifying by country and disease (impetigo/SITL).|||10.71|-1.59|
71050169|NCT00667810|141606264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38||||0.725|TWO_SIDED|95.0|-1.76|2.52|||Mixed Models Analysis|||||2.52|-1.76|0.725
71050170|NCT00667810|141606265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2||||0.149|TWO_SIDED|95.0|-1.15|7.56|||Mixed Models Analysis|||||7.56|-1.15|0.149
71050171|NCT00667810|141606265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.01||||0.375|TWO_SIDED|95.0|-2.44|6.46|||Mixed Models Analysis|||||6.46|-2.44|0.375
71050172|NCT00667810|141606266|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||Not specifed.|Log Rank|||||||0.030
70930470|NCT00626795|141359415|NON_INFERIORITY|The lower confidence limit greater or equal to -12.5% indicates non-inferiority.|Difference in percentage|-3.35|||||TWO_SIDED|95.0|-10.28|3.57|||||Estimated using a Cochran-Mantel-Haenszel approach, stratifying by country and disease (impetigo/SITL).|||3.57|-10.28|
71016472|NCT02044094|141541369|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|3.316|STANDARD_ERROR_OF_MEAN|2.367|||TWO_SIDED|95.0|-1.425|8.025|||||Hydromorphone - Placebo|"Week 4~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||8.025|-1.425|
71016473|NCT02044094|141541369|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|6.677|STANDARD_ERROR_OF_MEAN|2.367|||TWO_SIDED|95.0|1.936|11.418|||||Hydromorphone - Placebo|"Week 4~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||11.418|1.936|
71016474|NCT03353415|141541395|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
71016475|NCT03353415|141541396|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
71016476|NCT03353415|141541397|OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
71016477|NCT03353415|141541398|OTHER|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||||||0.45
71016478|NCT03353415|141541399|OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.35
71016479|NCT03353415|141541400|OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
71016480|NCT03353415|141541401|OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
71016481|NCT03353415|141541402|OTHER|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
71016482|NCT03353415|141541403|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
71016483|NCT03353415|141541404|OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71016484|NCT03353415|141541405|OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
71016485|NCT03353415|141541406|OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||||||0.09
71016486|NCT03353415|141541407|OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
71050173|NCT00667810|141606266|SUPERIORITY_OR_OTHER|||||||0.567|TWO_SIDED||||||Log Rank|||||||0.567
71050174|NCT00667810|141606267|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED||||||Log Rank|||||||0.079
71016487|NCT03353415|141541408|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
71016488|NCT03353415|141541409|OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
71016489|NCT03353415|141541410|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
71016490|NCT03353415|141541411|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
71016491|NCT03353415|141541412|OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
71016492|NCT03353415|141541413|OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
71016493|NCT03353415|141541414|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
71016494|NCT03353415|141541415|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
71016495|NCT03515837|141541454|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0122|TWO_SIDED|95.0|0.65|0.97|||Log Rank|One-sided p-value based on log-rank test stratified by PD-L1 expression; treatment history; geographic region of the enrolling site.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by PD-L1 expression; treatment history; geographic region of the enrolling site.|||0.97|0.65|0.0122
71050175|NCT00667810|141606267|SUPERIORITY_OR_OTHER|||||||0.675|TWO_SIDED||||||Log Rank|||||||0.675
71050176|NCT00667810|141606268|SUPERIORITY_OR_OTHER|||||||0.846|TWO_SIDED||||||Log Rank|||Not spsecified.||||0.846
71016496|NCT03515837|141541455|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0362|TWO_SIDED|95.0|0.69|1.02|||Log Rank|One-sided p-value based on log-rank test stratified by PD-L1 expression; treatment history; geographic region of the enrolling site.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by PD-L1 expression; treatment history; geographic region of the enrolling site.|||1.02|0.69|0.0362
71016497|NCT03515837|141541456|SUPERIORITY||Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0|-6.0|9.9|||||Based on Miettinen \& Nurminen method stratified by PD-L1 expression; treatment history; geographic region of the enrolling site.|||9.9|-6.0|
71016498|NCT03515837|141541458|OTHER||Difference in LS Means|1.59|||||TWO_SIDED|95.0|-1.93|5.1|||||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors PD-L1 expression, treatment history, and geographic region of the enrolling site as covariates.|||5.10|-1.93|
71016499|NCT03515837|141541459|OTHER||Hazard Ratio (HR)|0.93||||||95.0|0.68|1.27|||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by PD-L1 expression; treatment history; geographic region of the enrolling site.|||1.27|0.68|
71016500|NCT02545868|141541480|SUPERIORITY||normal distribution approximation|-30.7|||||TWO_SIDED|95.0|-50.5|-10.8||||||Difference in positive response, Group A minus Group B||-10.8|-50.5|
71016501|NCT02545868|141541481|SUPERIORITY||normal distribution approximation|-36.4|||||TWO_SIDED|95.0|-56.0|-16.7||||||Difference in positive response, Group A minus Group B||-16.7|-56.0|
71050177|NCT00667810|141606268|SUPERIORITY_OR_OTHER|||||||0.797|TWO_SIDED||||||Log Rank|||||||0.797
71050178|NCT00667810|141606269|SUPERIORITY_OR_OTHER|||||||0.933|TWO_SIDED||||||Log Rank|||||||0.933
71016502|NCT02545868|141541482|SUPERIORITY||normal distribution approximation|-47.0|||||TWO_SIDED|95.0|-63.2|-30.7||||||Difference in positive response, Group A minus Group B||-30.7|-63.2|
71016503|NCT02545868|141541486|SUPERIORITY||Normal Distribution Approximation|-50.7|||||TWO_SIDED|95.0|-62.7|-38.8||||||Serotype 1||-38.8|-62.7|
71016504|NCT02545868|141541486|SUPERIORITY||Normal Distribution Approximation|-43.3|||||TWO_SIDED|95.0|-56.5|-30.1||||||Serotype 2||-30.1|-56.5|
71050179|NCT00667810|141606269|SUPERIORITY_OR_OTHER|||||||0.714|TWO_SIDED||||||Log Rank|||||||0.714
71050180|NCT00667810|141606271|SUPERIORITY_OR_OTHER|||||||0.277|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.277
71050181|NCT00667810|141606271|SUPERIORITY_OR_OTHER|||||||0.996|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.996
71050182|NCT00667810|141606273|SUPERIORITY_OR_OTHER|||||||0.855|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.855
71050183|NCT00667810|141606273|SUPERIORITY_OR_OTHER|||||||0.423|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.423
71050184|NCT00667810|141606274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.516|TWO_SIDED|95.0|-0.65|0.33|||Mixed Models Analysis|||Change in DS score was analyzed using a REML based MMRM.||0.33|-0.65|0.516
71050185|NCT00667810|141606274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.257|TWO_SIDED|95.0|-0.79|0.21|||Mixed Models Analysis|||Change in DS score was analyzed using a REML based MMRM.||0.21|-0.79|0.257
71050186|NCT00667810|141606275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.238|TWO_SIDED|95.0|-0.96|0.24|||Mixed Models Analysis|||Change in CDR-SOB total score was analyzed using a REML based MMRM.||0.24|-0.96|0.238
71016505|NCT02545868|141541486|SUPERIORITY||Normal Distribution Approximation|-48.0|||||TWO_SIDED|95.0|-65.2|-30.9||||||Serotype 3||-30.9|-65.2|
71050187|NCT00667810|141606275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.564|TWO_SIDED|95.0|-0.78|0.43|||Mixed Models Analysis|||Change in CDR-SOB total score was analyzed using a REML based MMRM.||0.43|-0.78|0.564
71050188|NCT03514641|141606276|SUPERIORITY||LS Means difference|-2.72||||0.0025|TWO_SIDED|95.0|-4.47|-0.96|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||-0.96|-4.47|0.0025
71050189|NCT03514641|141606277|SUPERIORITY||Mean Difference (Final Values)|-2.43||||0.0117|TWO_SIDED|95.0|-4.32|-0.54|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||-0.54|-4.32|0.0117
71050190|NCT03514641|141606278|SUPERIORITY||Odds Ratio (OR)|1.3||||0.1317|TWO_SIDED|95.0|0.92|1.83||Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP|Covariance|||||1.83|0.92|0.1317
71050191|NCT03514641|141606279|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0113|TWO_SIDED|95.0|1.11|2.3|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||2.30|1.11|0.0113
71104952|NCT01968980|141717023|SUPERIORITY_OR_OTHER||LS Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|1.42|||TWO_SIDED|95.0|3.1|8.7||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||8.7|3.1|
70850719|NCT04518995|141189576|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.3|-0.6||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-0.6|-1.3|<0.0001
70850720|NCT04518995|141189576|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.6|-0.9||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-0.9|-1.6|<0.0001
71016506|NCT02545868|141541486|SUPERIORITY||Normal Distribution Approximation|-62.8|||||TWO_SIDED|95.0|-77.2|-48.4||||||Serotype 4||-48.4|-77.2|
71016507|NCT02545868|141541486|SUPERIORITY||Normal Distribution Approximation|-53.8|||||TWO_SIDED|95.0|-68.0|-39.7||||||Serotype 5||-39.7|-68.0|
71016508|NCT02545868|141541486|SUPERIORITY||Normal Distribution Approximation|-37.5|||||TWO_SIDED|95.0|-54.4|-20.7||||||Serotype 6B||-20.7|-54.4|
71016509|NCT02545868|141541486|SUPERIORITY||Normal Distribution Approximation|-58.3|||||TWO_SIDED|95.0|-73.1|-43.6||||||Serotype 7F||-43.6|-73.1|
71016510|NCT02545868|141541486|SUPERIORITY||Normal Distribution Approximation|-32.9|||||TWO_SIDED|95.0|-45.7|-20.1||||||Serotype 8||-20.1|-45.7|
71016511|NCT02545868|141541486|SUPERIORITY||Normal Distribution Approximation|-46.4|||||TWO_SIDED|95.0|-62.5|-30.4||||||Serotype 9N||-30.4|-62.5|
71016512|NCT02545868|141541486|SUPERIORITY||Normal Distribution Approximation|-40.4|||||TWO_SIDED|95.0|-55.7|-25.1||||||Serotype 9V||-25.1|-55.7|
71016513|NCT02545868|141541486|SUPERIORITY||Normal Distribution Approximation|-62.8|||||TWO_SIDED|95.0|-77.2|-48.4||||||Serotype 10A||-48.4|-77.2|
71016514|NCT02545868|141541486|SUPERIORITY||Normal Distribution Approximation|-52.5|||||TWO_SIDED|95.0|-69.4|-35.6||||||Serotype 11A||-35.6|-69.4|
71016515|NCT02545868|141541486|SUPERIORITY||Normal Distribution Approximation|-55.6|||||TWO_SIDED|95.0|-72.8|-38.3||||||Serotype 12F||-38.3|-72.8|
71016516|NCT02545868|141541486|SUPERIORITY||Normal Distribution Approximation|-25.5|||||TWO_SIDED|95.0|-41.4|-9.7||||||Serotype 14||-9.7|-41.4|
71016517|NCT02545868|141541486|SUPERIORITY||Normal Distribution Approximation|-47.9|||||TWO_SIDED|95.0|-63.9|-32.0||||||Serotype 15B||-32.0|-63.9|
71016518|NCT02545868|141541486|SUPERIORITY||Normal Distribution Approximation|-56.9|||||TWO_SIDED|95.0|-72.4|-41.4||||||Serotype 17F||-41.4|-72.4|
71016519|NCT02545868|141541486|SUPERIORITY||Normal Distribution Approximation|-52.4|||||TWO_SIDED|95.0|-67.4|-37.3||||||Serotype 18C||-37.3|-67.4|
71016520|NCT02545868|141541486|SUPERIORITY||Normal Distribution Approximation|-46.4|||||TWO_SIDED|95.0|-62.5|-30.4||||||Serotype 19A||-30.4|-62.5|
71016521|NCT02545868|141541486|SUPERIORITY||Normal Distribution Approximation|-52.5|||||TWO_SIDED|95.0|-68.8|-36.1||||||Serotype 19F||-36.1|-68.8|
71016522|NCT02545868|141541486|SUPERIORITY||Normal Distribution Approximation|-61.5|||||TWO_SIDED|95.0|-77.5|-45.4||||||Serotype 20||-45.4|-77.5|
71016523|NCT02545868|141541486|SUPERIORITY||Normal Distribution Approximation|-56.8|||||TWO_SIDED|95.0|-71.7|-42.0||||||Serotype 22F||-42.0|-71.7|
71016524|NCT02545868|141541486|SUPERIORITY||Normal Distribution Approximation|-33.2|||||TWO_SIDED|95.0|-51.7|-14.6||||||Serotype 23F||-14.6|-51.7|
71016525|NCT02545868|141541486|SUPERIORITY||Normal Distribution Approximation|-47.8|||||TWO_SIDED|95.0|-62.2|-33.5||||||Serotype 33F||-33.5|-62.2|
71016526|NCT02545868|141541487|SUPERIORITY||Normal Distribution Approximation|-13.4|||||TWO_SIDED|95.0|-21.6|-5.3||||||||-5.3|-21.6|
71016527|NCT02545868|141541488|SUPERIORITY||Normal Distribution Approximation|-59.7|||||TWO_SIDED|95.0|-72.6|-46.8||||||||-46.8|-72.6|
71016528|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-45.2|||||TWO_SIDED|95.0|-62.7|-27.6||||||Serotype 1- Difference in positive response, Group A1 minus Group B||-27.6|-62.7|
71016529|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-42.2|||||TWO_SIDED|95.0|-60.6|-23.8||||||Serotype 2- Difference in positive response, Group A1 minus Group B||-23.8|-60.6|
71016530|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-49.8|||||TWO_SIDED|95.0|-70.4|-29.2||||||Serotype 3- Difference in positive response, Group A1 minus Group B||-29.2|-70.4|
71016531|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-56.0|||||TWO_SIDED|95.0|-75.7|-36.3||||||Serotype 4- Difference in positive response, Group A1 minus Group B||-36.3|-75.7|
71016532|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-58.3|||||TWO_SIDED|95.0|-76.4|-40.3||||||Serotype 5- Difference in positive response, Group A1 minus Group B||-40.3|-76.4|
71016533|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-34.0|||||TWO_SIDED|95.0|-55.7|-12.2||||||Serotype 6B- Difference in positive response, Group A1 minus Group B||-12.2|-55.7|
70930471|NCT04159519|141359422|OTHER|Mixed model for repeated measure (MMRM) with fixed effects for treatment arm, visit, baseline value, and treatment-by-visit interaction with an unstructured covariance structure.|Least square mean difference|0.1062|||||TWO_SIDED|95.0|-0.0485|0.2609||||||Comparison with reference arm||0.2609|-0.0485|
71016534|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-42.5|||||TWO_SIDED|95.0|-61.8|-23.2||||||Serotype 7F- Difference in positive response, Group A1 minus Group B||-23.2|-61.8|
71016535|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-42.2|||||TWO_SIDED|95.0|-60.6|-23.8||||||Serotype 8- Difference in positive response, Group A1 minus Group B||-23.8|-60.6|
71016536|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-37.2|||||TWO_SIDED|95.0|-58.9|-15.5||||||Serotype 9N- Difference in positive response, Group A1 minus Group B||-15.5|-58.9|
71016537|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-36.6|||||TWO_SIDED|95.0|-57.3|-16.0||||||Serotype 9V- Difference in positive response, Group A1 minus Group B||-16.0|-57.3|
71016538|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-62.1|||||TWO_SIDED|95.0|-80.8|-43.5||||||Serotype 10A- Difference in positive response, Group A1 minus Group B||-43.5|-80.8|
71016539|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-50.1|||||TWO_SIDED|95.0|-71.0|-29.2||||||Serotype 11A- Difference in positive response, Group A1 minus Group B||-29.2|-71.0|
71016540|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-56.8|||||TWO_SIDED|95.0|-76.9|-36.8||||||Serotype 12F- Difference in positive response, Group A1 minus Group B||-36.8|-76.9|
71016541|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-20.8|||||TWO_SIDED|95.0|-41.4|-0.2||||||Serotype 14- Difference in positive response, Group A1 minus Group B||-0.2|-41.4|
71016542|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-52.8|||||TWO_SIDED|95.0|-72.8|-32.7||||||Serotype 15B- Difference in positive response, Group A1 minus Group B||-32.7|-72.8|
71016543|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-46.3|||||TWO_SIDED|95.0|-66.8|-25.8||||||Serotype 17F- Difference in positive response, Group A1 minus Group B||-25.8|-66.8|
71016544|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-42.5|||||TWO_SIDED|95.0|-61.8|-23.2||||||Serotype 18C- Difference in positive response, Group A1 minus Group B||-23.2|-61.8|
71016545|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-30.2|||||TWO_SIDED|95.0|-50.6|-9.7||||||Serotype 19A- Difference in positive response, Group A1 minus Group B||-9.7|-50.6|
71016546|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-46.3|||||TWO_SIDED|95.0|-66.8|-25.8||||||Serotype 19F- Difference in positive response, Group A1 minus Group B||-25.8|-66.8|
71016547|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-59.5|||||TWO_SIDED|95.0|-79.0|-40.0||||||Serotype 20- Difference in positive response, Group A1 minus Group B||-40.0|-79.0|
71050192|NCT03514641|141606280|SUPERIORITY||Mean Difference (Final Values)|-4.63|||<|0.0001|TWO_SIDED|95.0|-6.83|-2.42|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||-2.42|-6.83|<0.0001
71050193|NCT03514641|141606281|SUPERIORITY||Odds Ratio (OR)|1.86||||0.0004|TWO_SIDED|95.0|1.32|2.62|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||2.62|1.32|0.0004
71050194|NCT03514641|141606282|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.0863|TWO_SIDED|95.0|-1.79|0.12|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||0.12|-1.79|0.0863
71050195|NCT03514641|141606283|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0232|TWO_SIDED|95.0|1.06|2.08|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||2.08|1.06|0.0232
71016548|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-52.5|||||TWO_SIDED|95.0|-72.1|-32.8||||||Serotype 22F- Difference in positive response, Group A1 minus Group B||-32.8|-72.1|
71016549|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-28.1|||||TWO_SIDED|95.0|-50.7|-5.4||||||Serotype 23F- Difference in positive response, Group A1 minus Group B||-5.4|-50.7|
71016550|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-49.0|||||TWO_SIDED|95.0|-68.2|-29.7||||||Serotype 33F- Difference in positive response, Group A1 minus Group B||-29.7|-68.2|
71016551|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-61.8|||||TWO_SIDED|95.0|-78.1|-45.4||||||Serotype 1- Difference in positive response, Group A2 minus Group B||-45.4|-78.1|
71016552|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-52.9|||||TWO_SIDED|95.0|-70.6|-35.3||||||Serotype 2- Difference in positive response, Group A2 minus Group B||-35.3|-70.6|
71016553|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-55.9|||||TWO_SIDED|95.0|-75.3|-36.5||||||Serotype 3- Difference in positive response, Group A2 minus Group B||-36.5|-75.3|
71016554|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-64.7|||||TWO_SIDED|95.0|-82.6|-46.8||||||Serotype 4- Difference in positive response, Group A2 minus Group B||-46.8|-82.6|
71016555|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-52.9|||||TWO_SIDED|95.0|-70.6|-35.3||||||Serotype 5- Difference in positive response, Group A2 minus Group B||-35.3|-70.6|
71016556|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-38.2|||||TWO_SIDED|95.0|-59.3|-17.2||||||Serotype 6B- Difference in positive response, Group A2 minus Group B||-17.2|-59.3|
71016557|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-58.8|||||TWO_SIDED|95.0|-76.7|-40.9||||||Serotype 7F- Difference in positive response, Group A2 minus Group B||-40.9|-76.7|
71016558|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-29.4|||||TWO_SIDED|95.0|-46.1|-12.7||||||Serotype 8- Difference in positive response, Group A2 minus Group B||-12.7|-46.1|
71050196|NCT03514641|141606284|SUPERIORITY||Odds Ratio (OR)|1.81||||0.014|TWO_SIDED|95.0|1.13|2.91|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||2.91|1.13|0.0140
71050197|NCT03514641|141606285|SUPERIORITY||Mean Difference (Final Values)|-2.31||||0.0011|TWO_SIDED|95.0|-3.7|-0.92|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||-0.92|-3.70|0.0011
71050198|NCT03514641|141606286|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0094|TWO_SIDED|95.0|1.13|2.35|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||2.35|1.13|0.0094
71050199|NCT03514641|141606287|SUPERIORITY||Mean Difference (Final Values)|-3.2||||0.0083|TWO_SIDED|95.0|-5.57|-0.83|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||-0.83|-5.57|0.0083
71016559|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-35.3|||||TWO_SIDED|95.0|-56.4|-14.2||||||Serotype 9N- Difference in positive response, Group A2 minus Group B||-14.2|-56.4|
71016560|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-38.2|||||TWO_SIDED|95.0|-58.2|-18.2||||||Serotype 9V- Difference in positive response, Group A2 minus Group B||-18.2|-58.2|
71050200|NCT03514641|141606288|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.1085|TWO_SIDED|95.0|-1.87|0.19|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||0.19|-1.87|0.1085
71050201|NCT03514641|141606289|SUPERIORITY||Mean Difference (Final Values)|-1.25||||0.0837|TWO_SIDED|95.0|-2.67|0.17|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||0.17|-2.67|0.0837
71050202|NCT04536935|141606347|SUPERIORITY|A series of mixed effects models using restricted maximum likelihood estimation were built to test linear time change on the PHQ-9 and to test for condition differences at follow-up and change slope. Models were built in an outwardly nested fashion, such that an initial null model was computed, followed by models that added a random intercept, random time component, condition assignment, and condition x time interaction effects.|Slope|-1.5|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.8|-1.1|||Mixed Models Analysis|||||-1.1|-1.8|<.001
71050203|NCT04536935|141606348|OTHER|A series of mixed effects models using restricted maximum likelihood estimation were built to test linear time change on the GAD-7 and to test for condition differences at follow-up and change slope. Models were built in an outwardly nested fashion, such that an initial null model was computed, followed by models that added a random intercept, random time component, condition assignment, and condition x time interaction effects.|Slope|-1.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.6|-1.0|||Mixed Models Analysis|||||-1.0|-1.6|<.001
71050204|NCT04536935|141606349|OTHER|A series of mixed effects models using restricted maximum likelihood estimation were built to test linear time change on the DERS and to test for condition differences at follow-up and change slope. Models were built in an outwardly nested fashion, such that an initial null model was computed, followed by models that added a random intercept, random time component, condition assignment, and condition x time interaction effects.||||||0.73|||||||Mixed Models Analysis|||||||.73
70850721|NCT04518995|141189576|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-2.1|-1.4||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-1.4|-2.1|<0.0001
70850722|NCT04518995|141189576|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.7|-1.0||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.0|-1.7|<0.0001
70850723|NCT04518995|141189576|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-2.3|-1.5||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.5|-2.3|<0.0001
71050205|NCT04536935|141606350|OTHER|||||||0.25|||||||Mixed Models Analysis|||||||.25
71050206|NCT04536935|141606351|SUPERIORITY|||||||0.22|||||||ANOVA|||||||.22
70850724|NCT04518995|141189576|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-2.0|-1.3||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.3|-2.0|<0.0001
70850725|NCT04518995|141189576|SUPERIORITY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-2.6|-1.8||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.8|-2.6|<0.0001
70850726|NCT04518995|141189577|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001|TWO_SIDED|95.0|0.06|0.12||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 12||0.12|0.06|<0.0001
71016561|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-61.8|||||TWO_SIDED|95.0|-79.8|-43.7||||||Serotype 10A- Difference in positive response, Group A2 minus Group B||-43.7|-79.8|
71016562|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-38.2|||||TWO_SIDED|95.0|-59.3|-17.2||||||Serotype 11A- Difference in positive response, Group A2 minus Group B||-17.2|-59.3|
71016563|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-58.8|||||TWO_SIDED|95.0|-78.0|-39.6||||||Serotype 12F- Difference in positive response, Group A2 minus Group B||-39.6|-78.0|
71016564|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-17.6|||||TWO_SIDED|95.0|-37.4|2.1||||||Serotype 14- Difference in positive response, Group A2 minus Group B||2.1|-37.4|
71016565|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-50.0|||||TWO_SIDED|95.0|-69.6|-30.4||||||Serotype 15B- Difference in positive response, Group A2 minus Group B||-30.4|-69.6|
71016566|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-44.1|||||TWO_SIDED|95.0|-64.0|-24.2||||||Serotype 17F- Difference in positive response, Group A2 minus Group B||-24.2|-64.0|
71016567|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-61.8|||||TWO_SIDED|95.0|-79.4|-44.2||||||Serotype 18C- Difference in positive response, Group A2 minus Group B||-44.2|-79.4|
71050207|NCT04536935|141606352|SUPERIORITY|||||||0.48|||||||ANOVA|||||||.48
71050208|NCT04536935|141606353|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<.0001
71050209|NCT05070546|141606388|NON_INFERIORITY|Non-inferiority of Cohort 3 (Group 5) versus Cohorts 1 (Group 1) and 2 (Group 3) in terms of RSV A2 Strain neutralizing antibody titers against 14 days after vaccination, using a non-inferiority margin of 0.67 for the GMT ratio (Cohort 3 \[Group 5\]/Cohort 1\[Group1\] and 2 \[Group 3\])|Geometric Mean Ratio|1.41|||||TWO_SIDED|95.0|1.25|1.6|||Geometric Mean Ratio|||||1.60|1.25|
71050210|NCT05070546|141606388|NON_INFERIORITY|Non-inferiority of Cohort 3 (Group 5) versus Cohort 2 (Group 3 in terms of RSV A2 Strain neutralizing antibody titers against 14 days after vaccination, using a non-inferiority margin of 0.67 for the GMT ratio (Cohort 3 \[Group 5\]/Cohort 2 \[Group 3\])|Geometric mean ratio|1.54|||||TWO_SIDED|95.0|1.34|1.78|||Geometric Mean Ratio|||||1.78|1.34|
70930472|NCT04159519|141359423|OTHER|Comparison|Least square mean difference|-0.0343|||||TWO_SIDED|95.0|-0.2527|0.1841|||Mixed model for repeated measure (MMRM)|MMRM with fixed effects for treatment arm, visit, baseline value, and treatment-by-visit interaction with an unstructured covariance structure.||Comparison with reference arm||0.1841|-0.2527|
71050211|NCT05070546|141606389|NON_INFERIORITY|Non-inferiority of Cohort 3 (Group 5) versus Cohorts 1 (Group 1) and 2 (Group 3) in terms of RSV A2 Strain neutralizing antibody titers against 14 days after vaccination, using a non-inferiority margin of -10% for the GMT ratio (Cohort 3 \[Group 5\]/Cohort 1\[Group1\] and 2 \[Group 3\]).|Difference in Seroresponse rate|5.4|||||TWO_SIDED|95.0|0.3|10.9|||Difference in Seroresponse rate|||||10.9|0.3|
71050212|NCT05070546|141606389|NON_INFERIORITY|Non-inferiority of Cohort 3 (Group 5) versus Cohorts 1 (Group 1) and 2 (Group 3) in terms of RSV A2 Strain neutralizing antibody titers against 14 days after vaccination, using a non-inferiority margin of -10% for the GMT ratio (Cohort 3 \[Group 5\]/Cohort 2 \[Group 3\]).|Difference in Seroresponse rate|4.4|||||TWO_SIDED|95.0|-1.6|10.5|||Difference in Seroresponse rate|||||10.5|-1.6|
71050213|NCT01194973|141606415|SUPERIORITY_OR_OTHER||LS mean change from baseline|117.68|||<|0.0001|TWO_SIDED|95.0|92.77|142.59|||ANOVA|||||142.59|92.77|<0.0001
71050214|NCT01194973|141606421|SUPERIORITY_OR_OTHER||LS mean change from baseline|102.49|||<|0.0001|TWO_SIDED|95.0|68.15|136.82|||ANOVA|||||136.82|68.15|<0.0001
71050215|NCT02615171|141606485|OTHER|||||||0.0106|||||||t-test, 2 sided|||||||0.0106
71050216|NCT02615171|141606486|OTHER|||||||0.0027|||||||Chi-squared|||||||0.0027
71050217|NCT02615171|141606487|OTHER|||||||0.7829|||||||Wilcoxon rank sum test|||||||0.7829
71050218|NCT00888459|141606498|SUPERIORITY_OR_OTHER_LEGACY|||||||0.432||95.0|||||Chi-squared|||||||.432
71050219|NCT01000493|141606499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.62||||0.3624|TWO_SIDED|95.0|-17.9|6.65||The mixed effects model repeated measures (MMRM) analysis included treatment, week, Baseline total CAPS score and the treatment by week and Baseline. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between Placebo and Orvepitant 60 mg at Week 12.|||6.65|-17.9|0.3624
71050220|NCT01000493|141606500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.3156|TWO_SIDED|95.0|0.54|6.76|||Logistic regression analysis|The analysis method was logistic regression adjusted for Baseline CAPS total score.|Comparison between Placebo and Orvepitant 60 mg at Week 1. Odds ratios represent the odds of improvement, relative to placebo.|||6.76|0.54|0.3156
71050221|NCT01000493|141606500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.3024|TWO_SIDED|95.0|0.27|1.5|||Logistic regression analysis|The analysis method was logistic regression adjusted for Baseline CAPS total score.|Comparison between Placebo and Orvepitant 60 mg at Week 1. Odds ratios represent the odds of improvement, relative to placebo.|||1.50|0.27|0.3024
71104953|NCT01968980|141717023|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|1.53|||TWO_SIDED|95.0|-0.1|5.9||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||5.9|-0.1|
71104954|NCT01968980|141717024|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.0|STANDARD_ERROR_OF_MEAN|4.22|||TWO_SIDED|95.0|-25.3|-8.7||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-8.7|-25.3|
70850727|NCT04518995|141189577|SUPERIORITY||Risk Difference (RD)|0.17|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.12|0.22||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 12||0.22|0.12|<0.0001
71050222|NCT01000493|141606500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4||||0.1208|TWO_SIDED|95.0|0.79|7.28|||Logistic regression analysis|The analysis method was logistic regression adjusted for Baseline CAPS total score.|Comparison between Placebo and Orvepitant 60 mg at Week 8. Odds ratios represent the odds of improvement, relative to placebo.|||7.28|0.79|0.1208
71050223|NCT01000493|141606500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.27||||0.1331|TWO_SIDED|95.0|0.7|15.4|||Logistic regression analysis|The analysis method was logistic regression adjusted for Baseline CAPS total score.|Comparison between Placebo and Orvepitant 60 mg at Week 1. Odds ratios represent the odds of improvement, relative to placebo.|||15.4|0.70|0.1331
71050224|NCT01000493|141606502|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.87||||0.7015|TWO_SIDED|95.0|-5.35|3.61||The MMRM analysis model included treatment, week, Baseline total CAPS score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 1.|||3.61|-5.35|0.7015
71050225|NCT01000493|141606502|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.81||||0.4292|TWO_SIDED|95.0|-4.22|9.84||The MMRM analysis model included treatment, week, Baseline total CAPS score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||9.84|-4.22|0.4292
71050226|NCT01000493|141606502|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.64||||0.3702|TWO_SIDED|95.0|-14.9|5.62||The MMRM analysis model included treatment, week, Baseline total CAPS score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||5.62|-14.9|0.3702
71050227|NCT01000493|141606503|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.5719|TWO_SIDED|95.0|0.04|5.82|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to place. Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||5.82|0.04|0.5719
71050228|NCT01000493|141606503|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.908||95.0|0.07|20.1|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to place. Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||20.1|0.07|0.9080
71050229|NCT01000493|141606503|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.9486|TWO_SIDED|95.0|0.07|12.5|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to place. Comparison between placebo and orvepitant 60 mg once daily at Week 12.|||12.5|0.07|0.9486
70930473|NCT02246127|141359449|SUPERIORITY||Odds Ratio (OR)|0.65||||0.229|TWO_SIDED|95.0|0.32|1.32|||Regression, Cox|||significant differences between both arms is assumed in case p-val \< 0.05||1.32|0.32|0.229
70930474|NCT02246127|141359450|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.135|TWO_SIDED|95.0|0.9|2.19|||Regression, Cox|||significant differences between both arms is assumed in case p-val \< 0.05||2.19|0.90|0.135
70930475|NCT02246127|141359451|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.474|TWO_SIDED|95.0|0.77|1.75|||Regression, Cox|||significant differences between both arms is assumed in case p-val \< 0.05||1.75|0.77|0.474
71016568|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-52.9|||||TWO_SIDED|95.0|-72.3|-33.6||||||Serotype 19A- Difference in positive response, Group A2 minus Group B||-33.6|-72.3|
71016569|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-58.8|||||TWO_SIDED|95.0|-77.6|-40.1||||||Serotype 19F- Difference in positive response, Group A2 minus Group B||-40.1|-77.6|
71016570|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-70.6|||||TWO_SIDED|95.0|-87.4|-53.8||||||Serotype 20- Difference in positive response, Group A2 minus Group B||-53.8|-87.4|
71016571|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-67.6|||||TWO_SIDED|95.0|-84.8|-50.5||||||Serotype 22F- Difference in positive response, Group A2 minus Group B||-50.5|-84.8|
71016572|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-47.1|||||TWO_SIDED|95.0|-68.0|-26.1||||||Serotype 23F- Difference in positive response, Group A2 minus Group B||-26.1|-68.0|
71050230|NCT01000493|141606505|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.67||||0.5426|TWO_SIDED|95.0|-1.51|2.85||The MMRM analysis model included treatment, week, Baseline CAPS A/N subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 1.|||2.85|-1.51|0.5426
71050231|NCT01000493|141606505|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.51||||0.7552|TWO_SIDED|95.0|-2.73|3.75||The MMRM analysis model included treatment, week, Baseline CAPS A/N subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||3.75|-2.73|0.7552
70930476|NCT02246127|141359453|SUPERIORITY|||||||0.001|||||||Fisher Exact|||significant differences between both arms is assumed in case p-val \< 0.05||||0.001
71050232|NCT01000493|141606505|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.22||||0.3827|TWO_SIDED|95.0|-7.27|2.83||The MMRM analysis model included treatment, week, Baseline CAPS A/N subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||2.83|-7.27|0.3827
70930477|NCT02246127|141359455|SUPERIORITY|||||||0.012|||||||Fisher Exact|||significant differences between both arms is assumed in case p-val \< 0.05||||0.012
70930478|NCT02246127|141359456|SUPERIORITY|||||||0.001|||||||Fisher Exact|||significant differences between both arms is assumed in case p-val \< 0.05||||0.001
70930479|NCT02246127|141359457|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.168|TWO_SIDED|95.0|0.86|2.37|||Regression, Cox|||significant differences between both arms is assumed in case p-val \< 0.05||2.37|0.86|0.168
71016573|NCT02545868|141541490|SUPERIORITY||Normal Distribution Approximation|-50.0|||||TWO_SIDED|95.0|-68.5|-31.5||||||Serotype 33F- Difference in positive response, Group A2 minus Group B||-31.5|-68.5|
71016574|NCT02545868|141541492|SUPERIORITY||Normal Distribution Approximation|-25.5|||||TWO_SIDED|95.0|-41.6|-9.5||||||Strain = H1N1CA09 (Group A2 minus Group B)||-9.5|-41.6|
71016575|NCT02545868|141541492|SUPERIORITY||Normal Distribution Approximation|-14.0|||||TWO_SIDED|95.0|-35.2|7.3||||||Strain = BPHU13 (Group A2 minus Group B)||7.3|-35.2|
71016576|NCT02545868|141541492|SUPERIORITY||Normal Distribution Approximation|-25.9|||||TWO_SIDED|95.0|-45.5|-6.4||||||Strain = H3N2SW13 (Group A2 minus Group B)||-6.4|-45.5|
71016577|NCT02545868|141541492|SUPERIORITY||Normal Distribution Approximation|-19.4|||||TWO_SIDED|95.0|-50.7|11.8||||||Strain = BBRIS08 (Group A2 minus Group B)||11.8|-50.7|
71016578|NCT02545868|141541492|SUPERIORITY||Normal Distribution Approximation|-3.3|||||TWO_SIDED|95.0|-49.4|42.7||||||Strain = AHK4801 (Group A2 minus Group B)||42.7|-49.4|
70930480|NCT02246127|141359459|SUPERIORITY|||||||0.072|||||||Fisher Exact|||significant differences between both arms is assumed in case p-val \< 0.05||||0.072
70930481|NCT02246127|141359461|SUPERIORITY||Hazard Ratio (HR)|1.6||||0.079|TWO_SIDED|95.0|0.94|2.73|||Log Rank|||significant differences between both arms is assumed in case p-val \< 0.05||2.73|0.94|0.079
70930482|NCT01880515|141359475|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.4|||||TWO_SIDED|95.0|0.17|0.99||||||||0.99|0.17|
70930483|NCT01880515|141359478|SUPERIORITY|||||||0.41|||||||Log Rank|||||||0.41
70930484|NCT04734197|141359479|SUPERIORITY|||||||0.004||||||The threshold for statistical significance is p=0.05.|Fisher Exact|||Exploratory Phase 2 Study; the sample size of approximately 280-350 subjects (between 40 and 50 subjects per each of the 7 treatment groups) was based on medical judgement.||||0.0040
71016579|NCT02545868|141541493|SUPERIORITY||Normal Distribution Approximation|-41.8|||||TWO_SIDED|95.0|-61.9|-21.7||||||Strain = H1N1CA09 (Group A2 minus Group B)||-21.7|-61.9|
71016580|NCT02545868|141541493|SUPERIORITY||Normal Distribution Approximation|-37.6|||||TWO_SIDED|95.0|-59.7|-15.5||||||Strain = BPHU13 (Group A2 minus Group B)||-15.5|-59.7|
71016581|NCT02545868|141541493|SUPERIORITY||Normal Distribution Approximation|-59.5|||||TWO_SIDED|95.0|-78.2|-40.7||||||Strain = H3N2SW13 (Group A2 minus Group B)||-40.7|-78.2|
71016582|NCT02545868|141541493|SUPERIORITY||Normal Distribution Approximation|-45.6|||||TWO_SIDED|95.0|-76.0|-15.1||||||Strain = BBRIS08 (Group A2 minus Group B)||-15.1|-76.0|
71016583|NCT02545868|141541493|SUPERIORITY||Normal Distribution Approximation|-3.3|||||TWO_SIDED|95.0|-49.4|42.7||||||Strain = AHK4801 (Group A2 minus Group B)||42.7|-49.4|
71016584|NCT02545868|141541494|SUPERIORITY||Normal Distribution Approximation|-61.3|||||TWO_SIDED|95.0|-80.2|-42.3||||||Strain = H1N1CA09 - Difference in at least 4-fold response, Group A2 minus Group B||-42.3|-80.2|
71016585|NCT02545868|141541494|SUPERIORITY||Normal Distribution Approximation|-54.8|||||TWO_SIDED|95.0|-75.3|-34.4||||||Strain = BPHU13 - Difference in at least 4-fold response, Group A2 minus Group B||-34.4|-75.3|
71016586|NCT02545868|141541494|SUPERIORITY||Normal Distribution Approximation|-82.3|||||TWO_SIDED|95.0|-97.1|-67.5||||||Strain = H3N2SW13 - Difference in at least 4-fold response, Group A2 minus Group B||-67.5|-97.1|
71016587|NCT02545868|141541494|SUPERIORITY||Normal Distribution Approximation|-36.7|||||TWO_SIDED|95.0|-67.2|-6.1||||||Strain = BBRIS08 - Difference in at least 4-fold response, Group A2 minus Group B||-6.1|-67.2|
71016588|NCT02545868|141541494|SUPERIORITY||Normal Distribution Approximation|-6.7|||||TWO_SIDED|95.0|-63.8|50.5||||||Strain = AHK4801 - Difference in at least 4-fold response, Group A2 minus Group B||50.5|-63.8|
71016589|NCT02545868|141541495|SUPERIORITY||Normal Distribution Approximation|-61.3|||||TWO_SIDED|95.0|-80.2|-42.3||||||Strain = H1N1CA09 (Group A2 minus Group B) \[FDA\]||-42.3|-80.2|
71016590|NCT02545868|141541495|SUPERIORITY||Normal Distribution Approximation|-46.0|||||TWO_SIDED|95.0|-88.0|-4.0||||||Strain = H1N1CA09 (Group A2 minus Group B) \[Protocol\]||-4.0|-88.0|
71016591|NCT02545868|141541495|SUPERIORITY||Normal Distribution Approximation|-57.9|||||TWO_SIDED|95.0|-77.7|-38.1||||||Strain = BPHU13 (Group A2 minus Group B) \[FDA\]||-38.1|-77.7|
71016592|NCT02545868|141541495|SUPERIORITY||Normal Distribution Approximation|-55.6|||||TWO_SIDED|95.0|-88.0|-23.1||||||Strain = BPHU13 (Group A2 minus Group B) \[Protocol\]||-23.1|-88.0|
71016593|NCT02545868|141541495|SUPERIORITY||Normal Distribution Approximation|-78.5|||||TWO_SIDED|95.0|-94.8|-62.2||||||Strain = H3N2SW13 (Group A2 minus Group B) \[FDA\]||-62.2|-94.8|
71050233|NCT01000493|141606505|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.98||||0.4915|TWO_SIDED|95.0|-7.71|3.75||The MMRM analysis model included treatment, week, Baseline CAPS A/N subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 12.|||3.75|-7.71|0.4915
71016594|NCT02545868|141541495|SUPERIORITY||Normal Distribution Approximation|-57.8|||||TWO_SIDED|95.0|-100.0|-13.4||||||Strain = H3N2SW13 (Group A2 minus Group B) \[Protocol\]||-13.4|-100.0|
71016595|NCT02545868|141541495|SUPERIORITY||Normal Distribution Approximation|-36.7|||||TWO_SIDED|95.0|-67.2|-6.1||||||Strain = BBRIS08 (Group A2 minus Group B) \[FDA\]||-6.1|-67.2|
71016596|NCT02545868|141541495|SUPERIORITY||Normal Distribution Approximation|-25.0|||||TWO_SIDED|95.0|-67.4|17.4||||||Strain = BBRIS08 (Group A2 minus Group B) \[Protocol\]||17.4|-67.4|
71016597|NCT02545868|141541495|SUPERIORITY||Normal Distribution Approximation|-6.7|||||TWO_SIDED|95.0|-63.8|50.5||||||Strain = AHK4801 (Group A2 minus Group B) \[FDA\]||50.5|-63.8|
71016598|NCT01932801|141541512|SUPERIORITY|||||||0.461||||||Denotes exact fit for the omnibus model|Chi-squared|Complete omnibus model stats: χ2(18, N=308) = 17.93, CFI = 1.00, RMSEA \< .001, SRMR = .07||"We used piecewise growth modeling to test various treatment arm effects on this outcome. Because there is currently no appropriate way to report on piecewise growth models in clinicaltrials.gov reporting tables, we are reporting the omnibus model statistics on this page called analysis 1 and select parameters representing certain treatment arm effects on subsequent analysis pages. However, we note these do not constitute separate analyses, but various parameters within a single SEM model."||||.461
71016599|NCT01932801|141541512|SUPERIORITY||Slope|-0.48||||0.01|TWO_SIDED|95.0|-0.79|-0.18||Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period|z score for parameters||Linear effects of HaRT-A+XR-NTX compared to services-as usual control (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-.18|-.79|.01
71016600|NCT01932801|141541512|SUPERIORITY||Slope|-0.41||||0.01|TWO_SIDED|95.0|-0.67|-0.15|||z||Linear effects of HaRT-A+XR-NTX compared to services-as usual control (one of three dummy-coded variables) during treatment period|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-.15|-.67|.01
71016601|NCT01932801|141541512|SUPERIORITY||Slope|-0.23||||0.19|TWO_SIDED|95.0|-0.52|0.06|||z||Linear effects of HaRT-A+XR-NTX compared to services-as usual control (one of three dummy-coded variables) during treatment period|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||.06|-.52|.19
71016602|NCT01932801|141541513|SUPERIORITY|||||||0.347||||||Denotes exact fit for the omnibus model|Chi-squared|complete omnibus model statistics: χ2(20, N=308) = 21.89, CFI = 1.00, RMSEA = .02, SRMR = .03||"We used piecewise growth modeling to test various treatment arm effects on this outcome. Because there is currently no appropriate way to report on piecewise growth models in clinicaltrials.gov reporting tables, we are reporting the omnibus model statistics on this page called analysis 1 and select parameters representing certain treatment arm effects on subsequent analysis pages. However, we note these do not constitute separate analyses, but various parameters within a single SEM model."||||.347
71050234|NCT01000493|141606506|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.919|TWO_SIDED|95.0|-1.93|1.74||The MMRM analysis model included treatment, week, Baseline CAPS hyperarousal subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 1.|||1.74|-1.93|0.9190
71050235|NCT01000493|141606506|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.32||||0.3326|TWO_SIDED|95.0|-1.37|4.0||The MMRM analysis model included treatment, week, Baseline CAPS hyperarousal subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||4.00|-1.37|0.3326
71050236|NCT01000493|141606506|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.9712|TWO_SIDED|95.0|-3.91|3.77||The MMRM analysis model included treatment, week, Baseline CAPS hyperarousal subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||3.77|-3.91|0.9712
71016603|NCT01932801|141541513|SUPERIORITY||Slope|-2.22||||0.002|TWO_SIDED|95.0|-3.39|-1.06||Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period (one of three dummy-coded variables)|z||Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-1.06|-3.39|.002
71016604|NCT01932801|141541513|SUPERIORITY||Slope|-0.82||||0.208|TWO_SIDED|95.0|-1.89|0.25||Linear effects of HaRT-A+placebo compared to services-as usual control during treatment period (one of three dummy-coded variables)|z||Linear effects of HaRT-A+placebo compared to services-as usual control during treatment period (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||.25|-1.89|.208
71016605|NCT01932801|141541513|SUPERIORITY||Slope|-1.58||||0.025|TWO_SIDED|95.0|-2.73|-0.42||Linear effects of HaRT-A only compared to services-as usual control during treatment period (one of three dummy-coded variables)|z||Linear effects of HaRT-A only compared to services-as usual control during treatment period (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-.42|-2.73|.025
71016606|NCT01932801|141541514|SUPERIORITY|||||||0.028||||||"p value reflects omnibus model close fit"|Chi-squared|χ2(13, N=308) = 24.34, CFI = .98, RMSEA = .05, SRMR = .03||"We used piecewise growth modeling to test various treatment arm effects on this outcome. Because there is currently no appropriate way to report on piecewise growth models in clinicaltrials.gov reporting tables, we are reporting the omnibus model statistics on this page called analysis 1 and select parameters representing certain treatment arm effects on subsequent analysis pages. However, we note these do not constitute separate analyses, but various parameters within a single SEM model."||||.028
71016607|NCT01932801|141541514|SUPERIORITY||Slope|-4.42||||0.047|TWO_SIDED|95.0|-8.09|-0.76||Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period (one of three dummy-coded variables)|z||Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-.76|-8.09|.047
71016608|NCT01932801|141541514|SUPERIORITY||Slope|-5.95||||0.009|TWO_SIDED|95.0|-9.72|-2.19||Linear effects of HaRT-A+placebo compared to services-as usual control during treatment period (one of three dummy-coded variables)|z||Linear effects of HaRT-A+placebo compared to services-as usual control during treatment period (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-2.19|-9.72|.009
71016609|NCT01932801|141541514|SUPERIORITY||Slope|-4.12||||0.072|TWO_SIDED|95.0|-7.88|-0.36||Linear effects of HaRT-A only compared to services-as usual control during treatment period (one of three dummy-coded variables)|z||Linear effects of HaRT-A only compared to services-as usual control during treatment period (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-.36|-7.88|.072
71016610|NCT01932801|141541515|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.24||0.6|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the XR-NTX vs control group effects on alcohol frequency.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.6
71104955|NCT01968980|141717024|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.4|STANDARD_ERROR_OF_MEAN|4.9|||TWO_SIDED|95.0|-27.0|-7.8||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-7.8|-27.0|
71016611|NCT01932801|141541515|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.18||0.83|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the XR-NTX vs control group effects on alcohol frequency.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.83
71016612|NCT01932801|141541515|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.17||0.89|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the HaRT-A vs control group effects on alcohol frequency.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.89
71016613|NCT01932801|141541515|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.65|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the XR-NTX vs control group effects on alcohol quantity.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.65
71016614|NCT01932801|141541515|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.003|STANDARD_ERROR_OF_MEAN|0.02||0.87|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the placebo vs control group effects on alcohol quantity.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.87
71016615|NCT01932801|141541515|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.002|STANDARD_ERROR_OF_MEAN|0.02||0.91|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the HaRT-A vs control group effects on alcohol quantity.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.91
71016616|NCT01932801|141541515|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|0.24|STANDARD_ERROR_OF_MEAN|0.38||0.54|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all 4 treatment arms; however, this specific contrast is for the XR-NTX vs control group effects on alcohol related harm.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.54
71016617|NCT01932801|141541515|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|0.06|STANDARD_ERROR_OF_MEAN|0.32||0.84|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all 4 treatment arms; however, this specific contrast is for the placebo vs control effects on alcohol-related harm.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.84
71016618|NCT01932801|141541515|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|0.06|STANDARD_ERROR_OF_MEAN|0.29||0.84|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all 4 treatment arms; however, this specific contrast is for the HaRT-A vs control group effects on alcohol related harm|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.84
71016619|NCT01932801|141541516|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.41|STANDARD_ERROR_OF_MEAN|0.9||0.65|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails two treatment arms: XR-NTX vs placebo effects on alcohol frequency and alcohol craving (PACS).|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of the craving (PACS) slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.65
71050237|NCT01000493|141606506|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.92||||0.6711|TWO_SIDED|95.0|-5.22|3.39||The MMRM analysis model included treatment, week, Baseline CAPS hyperarousal subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 12.|||3.39|-5.22|0.6711
71050238|NCT01000493|141606507|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57||||0.5532|TWO_SIDED|95.0|0.36|6.92||The analysis method was logistic regression adjusted for Baseline total Clinical Global Impression-Severity of Illness scales (CGI-S) score.|Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. Comparison between placebo and orvepitant 60 mg once daily at Week 1.|||6.92|0.36|0.5532
71104956|NCT01968980|141717024|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|5.04|||TWO_SIDED|95.0|-19.4|0.4||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||0.4|-19.4|
71104957|NCT01968980|141717025|SUPERIORITY_OR_OTHER||LS Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|95.0|2.9|7.8||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||7.8|2.9|
71104958|NCT01968980|141717025|SUPERIORITY_OR_OTHER||LS Mean Difference|4.6|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|2.5|6.8||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||6.8|2.5|
71104959|NCT01968980|141717025|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|1.22|||TWO_SIDED|95.0|0.5|5.4||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||5.4|0.5|
71104960|NCT01968980|141717026|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|95.0|-2.3|3.6||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||3.6|-2.3|
71104961|NCT01968980|141717026|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|95.0|-1.9|3.2||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||3.2|-1.9|
71104962|NCT01968980|141717026|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|1.39|||TWO_SIDED|95.0|-1.9|3.6||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||3.6|-1.9|
71104963|NCT01968980|141717027|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.0|STANDARD_ERROR_OF_MEAN|4.22|||TWO_SIDED|95.0|-25.3|-8.7||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-8.7|-25.3|
71104964|NCT01968980|141717027|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.4|STANDARD_ERROR_OF_MEAN|4.9|||TWO_SIDED|95.0|-27.0|-7.8||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-7.8|-27.0|
70850728|NCT04518995|141189577|SUPERIORITY||Risk Difference (RD)|0.28|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.23|0.33||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 24||0.33|0.23|<0.0001
71104965|NCT01968980|141717027|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|5.04|||TWO_SIDED|95.0|-19.4|0.4||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||0.4|-19.4|
71104966|NCT01968980|141717028|SUPERIORITY_OR_OTHER||LS Mean Difference|-78.8|STANDARD_ERROR_OF_MEAN|3.75|||TWO_SIDED|95.0|-86.2|-71.4||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-71.4|-86.2|
71104967|NCT01968980|141717029|SUPERIORITY_OR_OTHER||LS Mean Difference|-83.2|STANDARD_ERROR_OF_MEAN|4.15|||TWO_SIDED|95.0|-91.3|-75.0||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-75.0|-91.3|
71104968|NCT01968980|141717030|SUPERIORITY_OR_OTHER||LS Mean Difference|-87.0|STANDARD_ERROR_OF_MEAN|4.25|||TWO_SIDED|95.0|-95.4|-78.7||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-78.7|-95.4|
71104969|NCT01968980|141717031|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.8|STANDARD_ERROR_OF_MEAN|2.71|||TWO_SIDED|95.0|-59.2|-48.5||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-48.5|-59.2|
71104970|NCT01968980|141717032|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.8|STANDARD_ERROR_OF_MEAN|1.47|||TWO_SIDED|95.0|-14.7|-8.9||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-8.9|-14.7|
71104971|NCT01968980|141717033|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|2.0|4.9||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||4.9|2.0|
71104972|NCT01968980|141717034|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-2.2|-1.8||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-1.8|-2.2|
70850729|NCT04518995|141189577|SUPERIORITY||Risk Difference (RD)|0.38|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.32|0.45||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 24||0.45|0.32|<0.0001
71016620|NCT01932801|141541516|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.04||0.46|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails 2 treatment arms: XR-NTX vs placebo effects on craving and alcohol quantity.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of the alcohol craving (PACS) slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.46
71016621|NCT01932801|141541516|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.57|STANDARD_ERROR_OF_MEAN|0.75||0.45|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails two treatment arms: XR-NTX vs placebo effects on craving and alcohol-related harm|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of alcohol craving (PACS) slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.45
71016622|NCT01932801|141541517|SUPERIORITY|||||||0.95||||||Denotes exact fit for the omnibus model|Chi-squared|Complete omnibus model : χ2(12, N=308) = .75, CFI = 1.00, RMSEA \< .001, SRMR = .008||"We used piecewise growth modeling to test various treatment arm effects on this outcome. Because there is currently no appropriate way to report on piecewise growth models in clinicaltrials.gov reporting tables, we are reporting the omnibus model statistics on this page called analysis 1 and select parameters representing certain treatment arm effects on subsequent analysis pages. However, we note these do not constitute separate analyses, but various parameters within a single SEM model."||||.95
71016623|NCT01932801|141541517|SUPERIORITY||Slope|-0.04||||0.75|TWO_SIDED|95.0|-0.24|0.16||Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period (one of three dummy-coded variables)|Chi-squared|||"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model."||.16|-.24|.75
71016624|NCT01932801|141541517|SUPERIORITY||Slope|-0.15||||0.2|TWO_SIDED|95.0|-0.34|0.04|||Chi-squared|Linear effects of HaRT-A+placebo compared to services-as usual control during treatment period (one of three dummy-coded variables)||"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model."||.04|-.34|.20
71016625|NCT01932801|141541517|SUPERIORITY||Slope|0.1||||0.39|TWO_SIDED|95.0|-0.09|0.29|||Chi-squared|Linear effects of HaRT-A compared to services-as usual control during treatment period (one of three dummy-coded variables)||"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model."||.29|-.09|.39
71016626|NCT01932801|141541518|SUPERIORITY||incident rate ratio|0.98|||>|0.84|TWO_SIDED|95.0|0.83|1.16|||z|||We conducted a generalized estimating equations analysis (negative binomial distribution, log link) to test whether number of adverse events reported increased from baseline to the follow-ups differentially across placebo and XR-NTX groups||1.16|.83|>.84
71016627|NCT00448630|141541521|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||We hypothesize that atypical antipsychotic therapy effects the metabolic syndrome parameters, particularly body mass index.||||<0.001
71016628|NCT00448630|141541522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.49||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.490
71016629|NCT00448630|141541522|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
71050239|NCT01000493|141606507|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.4508|TWO_SIDED|95.0|0.54|3.93|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 2.|||3.93|0.54|0.4508
71104973|NCT01968980|141717034|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-2.1|-1.6||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-1.6|-2.1|
71104974|NCT01968980|141717034|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-1.8|-1.3||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-1.3|-1.8|
71104975|NCT01968980|141717035|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.5|-0.4||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-0.4|-0.5|
71016630|NCT00448630|141541522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.006
71050240|NCT01000493|141606507|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.9234|TWO_SIDED|95.0|0.42|2.62|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||2.62|0.42|0.9234
70930485|NCT04734197|141359480|SUPERIORITY|||||||0.3111|||||||Fisher Exact|The threshold for statistical significance is p=0.05.||"Mixed Model for Repeated Measures (MMRM) analysis included fixed effects of baseline TBUT, age, treatment, visit, and treatment by visit interaction.~Least squares means (LSMs) of the absolute TBUT change from baseline and their 95% CIs were estimated from the MMRM model for each treatment group."||||0.3111
70930486|NCT04734197|141359481|SUPERIORITY|||||||0.2027||||||The threshold for statistical significance is p=0.05.|Fisher Exact|||"MMRM analysis included fixed effects of baseline Schirmer test score, age, treatment, visit, and treatment by visit interaction.~LSMs of the absolute change from baseline in Schirmer test score and their 95% CIs were estimated from the MMRM model for each treatment group."||||0.2027
71016631|NCT00448630|141541522|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
71016632|NCT00448630|141541522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.003
71050241|NCT01000493|141606507|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.48||||0.0662|TWO_SIDED|95.0|0.94|6.53|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 1|||6.53|0.94|0.0662
70930487|NCT03364127|141359495|SUPERIORITY||Mean Difference (Net)|-0.12||||0.702|TWO_SIDED|95.0|-0.76|0.51|||ANCOVA|Full information maximum likelihood for missing data and to retain participants for intention to treat model. Adjusted for baseline value.||||.51|-.76|0.702
70930488|NCT03364127|141359496|SUPERIORITY||Mean Difference (Net)|0.1||||0.77|TWO_SIDED|95.0|-0.58|0.79|||ANCOVA|Full information maximum likelihood for missing data and to retain participants for intention to treat model. Adjusted for baseline value.||||.79|-.58|0.77
70930489|NCT03364127|141359497|SUPERIORITY||Mean Difference (Net)|1.16||||0.436|TWO_SIDED|95.0|-1.76|4.09|||ANCOVA|Full information maximum likelihood for missing data and to retain participants for intention to treat model. Adjusted for baseline value.||||4.09|-1.76|0.436
71016633|NCT00448630|141541522|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
71016634|NCT00448630|141541522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.050
71016635|NCT00448630|141541522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0012
71016636|NCT00448630|141541522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0078||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0078
71050242|NCT01000493|141606507|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.2767|TWO_SIDED|95.0|0.61|5.48|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||5.48|0.61|0.2767
70930490|NCT03364127|141359498|SUPERIORITY||Hazard Ratio (HR)|2.72||||0.017|TWO_SIDED|95.0|1.13|6.54||Kaplan-Meier curves by treatment arm were examined to determine the rates of return to baseline over the 12-week follow-up period .|Log Rank|||Goal was to assess duration of effect among those who showed a response to the intervention (1.5 or greater decrease in PIN).||6.54|1.13|0.017
70941540|NCT02762500|141383837|SUPERIORITY||Risk Difference (RD)|-6.5||||0.235|TWO_SIDED|90.0|-21.1|8.2||one-sided p-value|Chi-squared|Statistical test was a one-sided performed at the 5% level of significance. Pearson chi-square test was used to test the null hypothesis.|90% CI obtained based on normal approximation.|The response rate difference is the mean difference in response rates between the treatment and placebo responders. The p-value is based on one-sided Pearson chi-square test.||8.2|-21.1|0.235
71016637|NCT00448630|141541522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0001
71016638|NCT00448630|141541522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0133||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0133
71016639|NCT00448630|141541522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0142||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0142
71016640|NCT00448630|141541522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0265||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0265
71016641|NCT00448630|141541522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1613||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1613
71016642|NCT00448630|141541522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2644||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2644
71016643|NCT00448630|141541522|SUPERIORITY_OR_OTHER_LEGACY|||||||5e-06||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.000005
71016644|NCT00448630|141541522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7385||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7385
71016645|NCT00448630|141541522|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||||||1.0000
71016646|NCT00448630|141541522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6813||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6813
71016647|NCT00448630|141541522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0024||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0024
71016648|NCT00448630|141541522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2237||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2237
71016649|NCT00448630|141541522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5774||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5774
71016650|NCT00448630|141541522|SUPERIORITY_OR_OTHER_LEGACY|||||||1e-06||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.000001
71016651|NCT00448630|141541522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2502||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2502
71016652|NCT00448630|141541522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5224||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5224
71016653|NCT00448630|141541522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0001
71016654|NCT00448630|141541522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0002
71016655|NCT00448630|141541522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8166||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8166
71050243|NCT01000493|141606507|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.17||||0.0588|TWO_SIDED|95.0|0.96|10.5|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 10.|||10.5|0.96|0.0588
70930491|NCT04602611|141359541|SUPERIORITY||Coefficient of negative binomial model|0.0547||||0.8|TWO_SIDED|95.0|-0.368|0.4773||The a priori threshold for statistical significance was 0.025.|Regression, Negative binomial|Model was estimated without adjustments (sole covariate was treatment; coefficient was the estimated treatment effect) using 180 degrees of freedom.|The estimated coefficient was associated with Oncology Nurse Navigation with reference to Standard of Care.|The study was designed with co-primary objectives evaluating acute care utilization (ACU) and 6-month OS rate. Power/sample size were calculated based on the OS objective. The overall type I error rate was alpha=0.05; the co-primary objectives were powered at the 2-sided alpha=0.025 significance level. Three hundred evaluable subjects would have provided \>=93% power to detect a 20% reduction in ACU (assuming there were 6 ACUs per year in SOC arm). The study did not achieve targeted enrollment.||0.4773|-0.3680|0.80
71016656|NCT00448630|141541523|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||We hypothesize that atypical antipsychotic therapy effects the metabolic syndrome parameters, particularly body mass index.||||<0.001
71016657|NCT00448630|141541524|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).||||<0.001
71050244|NCT01000493|141606507|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.33||||0.1032|TWO_SIDED|95.0|0.78|14.1|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 12.|||14.1|0.78|0.1032
71050245|NCT01000493|141606508|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.1743|TWO_SIDED|95.0|-0.29|0.05||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 1.|||0.05|-0.29|0.1743
71016658|NCT00448630|141541525|SUPERIORITY_OR_OTHER_LEGACY|||||||0.544||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).||||0.544
71016659|NCT00448630|141541526|SUPERIORITY_OR_OTHER_LEGACY|||||||0.245||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).||||0.245
71016660|NCT00448630|141541527|SUPERIORITY_OR_OTHER_LEGACY|||||||0.362||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).||||0.362
71016661|NCT00448630|141541528|SUPERIORITY_OR_OTHER_LEGACY|||||||0.176||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).||||0.176
71016662|NCT00448630|141541529|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).||||<0.001
71016663|NCT00448630|141541530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.524||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.524
71050246|NCT01000493|141606508|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.1181|TWO_SIDED|95.0|-0.46|0.05||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 2.|||0.05|-0.46|0.1181
70941541|NCT02762500|141383838|SUPERIORITY||Risk Difference (RD)|-9.7||||0.14|TWO_SIDED|90.0|-24.3|5.0||one-sided p-value|Chi-squared|Statistical test was a one-sided performed at the 5% level of significance. Pearson chi-square test was used to test the null hypothesis.|90% CI obtained based on normal approximation.|The response rate difference is the mean difference in response rates between the treatment and placebo responders. The p-value is based on one-sided Pearson chi-square test.||5.0|-24.3|0.140
71016664|NCT00448630|141541530|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
71016665|NCT00448630|141541530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.005
71016666|NCT00448630|141541530|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
71016667|NCT00448630|141541530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.009
71016668|NCT00448630|141541530|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
71016669|NCT00448630|141541530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.047
71016670|NCT00448630|141541530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0007
71016671|NCT00448630|141541530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0057||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0057
71016672|NCT00448630|141541530|SUPERIORITY_OR_OTHER_LEGACY|||||||9e-05||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.00009
71016673|NCT00448630|141541530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0201||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0201
71016674|NCT00448630|141541530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0095||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0095
71050247|NCT01000493|141606508|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.9698|TWO_SIDED|95.0|-0.35|0.34||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||0.34|-0.35|0.9698
71050248|NCT01000493|141606508|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.1341|TWO_SIDED|95.0|-0.69|0.09||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 6.|||0.09|-0.69|0.1341
71050249|NCT01000493|141606508|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.61||||0.0064|TWO_SIDED|95.0|-1.04|-0.18||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||-0.18|-1.04|0.0064
71050250|NCT01000493|141606508|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.1095|TWO_SIDED|95.0|-0.98|0.1||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 10.|||0.10|-0.98|0.1095
71050251|NCT01000493|141606508|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32||||0.2814|TWO_SIDED|95.0|-0.9|0.27||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 12.|||0.27|-0.90|0.2814
71050252|NCT01000493|141606515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.92||||0.0083|TWO_SIDED|95.0|-3.33|-0.5||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 1|||-0.50|-3.33|0.0083
71050253|NCT01000493|141606515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.94||||0.0311|TWO_SIDED|95.0|-3.71|-0.18||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 2.|||-0.18|-3.71|0.0311
71050254|NCT01000493|141606515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.89||||0.1155|TWO_SIDED|95.0|-4.26|0.47||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||0.47|-4.26|0.1155
71104976|NCT01968980|141717035|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.4|-0.4||||||Week 24:LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-0.4|-0.4|
71016675|NCT00448630|141541530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0386||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0386
71016676|NCT00448630|141541530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1976||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1976
71016677|NCT00448630|141541530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2383||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2383
71016678|NCT00448630|141541530|SUPERIORITY_OR_OTHER_LEGACY|||||||2e-05||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.00002
71016679|NCT00448630|141541530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8297||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8297
71016680|NCT00448630|141541530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9081||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.9081
71016681|NCT00448630|141541530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7386||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7386
71016682|NCT00448630|141541530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0024||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0024
71016683|NCT00448630|141541530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2587||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2587
71016684|NCT00448630|141541530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6263||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6263
71016685|NCT00448630|141541530|SUPERIORITY_OR_OTHER_LEGACY|||||||1e-06||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.000001
71016686|NCT00448630|141541530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2589||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2589
71016687|NCT00448630|141541530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5153||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5153
71016688|NCT00448630|141541530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0003
71016689|NCT00448630|141541530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0005
71016690|NCT00448630|141541530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8952||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8952
71016691|NCT00448630|141541531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.197||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.197
71016692|NCT00448630|141541531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.010
71016693|NCT00448630|141541531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.012
71016694|NCT00448630|141541531|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
71016695|NCT00448630|141541531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.282||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.282
71016696|NCT00448630|141541531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.040
70941542|NCT02762500|141383839|SUPERIORITY||Mean Difference (Final Values)|-44.59||||0.032|TWO_SIDED|90.0|-78.66|-10.53|||ANCOVA|The mean change from baseline at Week 8 was analyzed using ANCOVA with a factor for treatment and a covariate for baseline scores.||Subjects included in this analysis were those with a baseline fecal calprotectin value ≥ 250 µg/g.||-10.53|-78.66|0.032
71016697|NCT00448630|141541531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.004
71016698|NCT00448630|141541531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0193||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0193
71016699|NCT00448630|141541531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0065||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0065
71016700|NCT00448630|141541531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0002
71016701|NCT00448630|141541531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3172||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3172
71016702|NCT00448630|141541531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0116||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0116
71016703|NCT00448630|141541531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0016||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0016
71016704|NCT00448630|141541531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.26||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2600
71016705|NCT00448630|141541531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2309||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2309
71016706|NCT00448630|141541531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0063||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0063
71016707|NCT00448630|141541531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8158||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8158
71016708|NCT00448630|141541531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3968||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3968
70941543|NCT02762500|141383840|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.708|TWO_SIDED|90.0|-0.6|0.95|||ANCOVA|The mean change from baseline at Week 8 was analyzed using ANCOVA with a factor for treatment and a covariate for baseline scores.||||0.95|-0.60|0.708
71016709|NCT00448630|141541531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7193||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7193
71016710|NCT00448630|141541531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0127||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0127
71016711|NCT00448630|141541531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2351||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2351
71016712|NCT00448630|141541531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5672||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5672
71016713|NCT00448630|141541531|SUPERIORITY_OR_OTHER_LEGACY|||||||9e-05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.00009
71016714|NCT00448630|141541531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1774||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1774
71016715|NCT00448630|141541531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6082||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6082
71016716|NCT00448630|141541531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0079||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0079
71016717|NCT00448630|141541531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0014
71016718|NCT00448630|141541531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5587||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5587
71016719|NCT00448630|141541532|SUPERIORITY_OR_OTHER_LEGACY|||||||0.077||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.077
71016720|NCT00448630|141541532|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.039
71016721|NCT00448630|141541532|SUPERIORITY_OR_OTHER_LEGACY|||||||0.978||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.978
71016722|NCT00448630|141541532|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
71016723|NCT00448630|141541532|SUPERIORITY_OR_OTHER_LEGACY|||||||0.593||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.593
71016724|NCT00448630|141541532|SUPERIORITY_OR_OTHER_LEGACY|||||||0.987||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.987
71016725|NCT00448630|141541532|SUPERIORITY_OR_OTHER_LEGACY|||||||0.174||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.174
71016726|NCT00468312|141541533|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.||||||<0.001
71016727|NCT00468312|141541534|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.||||||0.026
71016728|NCT00468312|141541535|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.||||||<0.001
71016729|NCT00468312|141541536|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.||||||<0.001
71016730|NCT00468312|141541537|SUPERIORITY_OR_OTHER_LEGACY|||||||0.269||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.||||||0.269
71016731|NCT01052038|141541538|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|||||||<0.001
71016732|NCT01052038|141541538|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0|||<|0.001|TWO_SIDED|95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|0|<0.001
71016733|NCT01052038|141541538|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0|||<|0.001|TWO_SIDED|95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|0|<0.001
71016734|NCT01052038|141541539|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|Dunn's post hoc-test corrected for 12 comparisons.||||||<0.001
71016735|NCT01052038|141541539|SUPERIORITY_OR_OTHER||Median Difference (Net)|22.0||||0.005|TWO_SIDED|95.0|14.0|29.0|||Wilcoxon (Mann-Whitney)|||||29|14|0.005
71016736|NCT01052038|141541539|SUPERIORITY_OR_OTHER||Median Difference (Net)|14.0||||0.004|TWO_SIDED|95.0|7.0|22.0|||Wilcoxon (Mann-Whitney)|||||22|7|0.004
71016737|NCT01052038|141541540|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared, Corrected|||||||0.004
71016738|NCT01052038|141541541|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Kruskal-Wallis|Post hoc test using Dunn's test corrected for 12 comparisons||||||0.01
71016739|NCT01052038|141541541|SUPERIORITY_OR_OTHER||Median Difference (Net)|10.0||||0.003||95.0|0.0|20.0|||Wilcoxon (Mann-Whitney)|||||20|0|0.003
71016740|NCT01052038|141541542|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Chi-squared, Corrected|||||||0.04
71016741|NCT03692078|141541614|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|6.116|||<|0.0001|TWO_SIDED|95.0|5.976|6.255|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)"||6.255|5.976|<.0001
71016742|NCT03692078|141541614|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|6.073|||<|0.0001|TWO_SIDED|95.0|5.963|6.183|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)"||6.183|5.963|<.0001
71016743|NCT03692078|141541614|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|5.736|||<|0.0001|TWO_SIDED|95.0|5.605|5.868|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)"||5.868|5.605|<.0001
71016744|NCT03692078|141541614|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|5.792|||<|0.0001|TWO_SIDED|95.0|5.687|5.897|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)"||5.897|5.687|<.0001
71016745|NCT03692078|141541614|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|5.835|||<|0.0001|TWO_SIDED|95.0|5.701|5.969|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)"||5.969|5.701|<.0001
71016746|NCT03692078|141541614|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|5.799|||<|0.0001|TWO_SIDED|95.0|5.694|5.904|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)"||5.904|5.694|<.0001
71016747|NCT03692078|141541614|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|4.881|||<|0.0001|TWO_SIDED|95.0|4.713|5.048|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)"||5.048|4.713|<.0001
71050255|NCT01000493|141606515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.89||||0.021|TWO_SIDED|95.0|-5.33|-0.45||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 6.|||-0.45|-5.33|0.0210
71050256|NCT01000493|141606515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.86||||0.0582|TWO_SIDED|95.0|-5.83|0.1||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||0.10|-5.83|0.0582
71050257|NCT01000493|141606515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.88||||0.0927|TWO_SIDED|95.0|-6.25|0.49||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 10.|||0.49|-6.25|0.0927
71016748|NCT03692078|141541614|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|4.844|||<|0.0001|TWO_SIDED|95.0|4.711|4.977|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)"||4.977|4.711|<.0001
71016749|NCT03692078|141541614|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|5.185|||<|0.0001|TWO_SIDED|95.0|5.021|5.35|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)"||5.350|5.021|<.0001
71016750|NCT03692078|141541614|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|4.933|||<|0.0001|TWO_SIDED|95.0|4.801|5.066|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)"||5.066|4.801|<.0001
71016751|NCT03692078|141541614|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|5.014|||<|0.0001|TWO_SIDED|95.0|4.852|5.175|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)"||5.175|4.852|<.0001
71016752|NCT03692078|141541614|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|4.892|||<|0.0001|TWO_SIDED|95.0|4.763|5.02|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)"||5.020|4.763|<.0001
71016753|NCT03692078|141541614|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)"|Mean Difference (Net)|-0.379||||0.0013|TWO_SIDED|95.0|-0.646|-0.112|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)"||-0.112|-0.646|0.0013
71016754|NCT03692078|141541614|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)"|Mean Difference (Net)|-0.281||||0.0034|TWO_SIDED|95.0|-0.496|-0.065|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)"||-0.065|-0.496|0.0034
71050258|NCT01000493|141606515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.8954|TWO_SIDED|95.0|-4.36|3.83||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 12.|||3.83|-4.36|0.8954
71050259|NCT01941940|141606525|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71050260|NCT01941940|141606531|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71050261|NCT01941940|141606533|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71050262|NCT01941940|141606533|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71050263|NCT01941940|141606533|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71050264|NCT01941940|141606534|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71016755|NCT03692078|141541614|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)"|Mean Difference (Net)|-0.281||||0.0354|TWO_SIDED|95.0|-0.549|-0.012|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)"||-0.012|-0.549|0.0354
71016756|NCT03692078|141541614|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)"|Mean Difference (Net)|-0.274||||0.0044|TWO_SIDED|95.0|-0.489|-0.059|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)"||-0.059|-0.489|0.0044
71016757|NCT03692078|141541614|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)"|Mean Difference (Net)|-1.235|||<|0.0001|TWO_SIDED|95.0|-1.539|-0.93|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)"||-0.930|-1.539|<.0001
71016758|NCT03692078|141541614|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)"|Mean Difference (Net)|-1.229|||<|0.0001|TWO_SIDED|95.0|-1.475|-0.983|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)"||-0.983|-1.475|<.0001
71016759|NCT03692078|141541614|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)"|Mean Difference (Net)|-0.93|||<|0.0001|TWO_SIDED|95.0|-1.23|-0.63|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)"||-0.630|-1.230|<.0001
71016760|NCT03692078|141541614|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)"|Mean Difference (Net)|-1.14|||<|0.0001|TWO_SIDED|95.0|-1.383|-0.896|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)"||-0.896|-1.383|<.0001
71050265|NCT01941940|141606534|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71050266|NCT01941940|141606534|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71050267|NCT01941940|141606537|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-68: Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71050268|NCT01941940|141606537|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-68: Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71050269|NCT01941940|141606537|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-68: Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71050270|NCT01941940|141606537|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-28: Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71104977|NCT01968980|141717035|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.4|-0.3||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-0.3|-0.4|
71104978|NCT01968980|141717036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|51.8|||||TWO_SIDED|95.0|25.24|106.1||||||Week 12: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.||106.10|25.24|
71104979|NCT01968980|141717036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|66.9|||||TWO_SIDED|95.0|30.32|147.43||||||Week 24: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.||147.43|30.32|
71016761|NCT03692078|141541614|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)"|Mean Difference (Net)|0.723|||<|0.0001|TWO_SIDED|95.0|0.436|1.009|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)"||1.009|0.436|<.0001
71016762|NCT03692078|141541614|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)"|Mean Difference (Net)|0.901|||<|0.0001|TWO_SIDED|95.0|0.667|1.134|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)"||1.134|0.667|<.0001
71016763|NCT03692078|141541614|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)"|Mean Difference (Net)|0.821|||<|0.0001|TWO_SIDED|95.0|0.533|1.109|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)"||1.109|0.533|<.0001
71050271|NCT01941940|141606537|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-28: Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71050272|NCT01941940|141606537|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-28: Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71050273|NCT01941940|141606538|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-66: Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
70850730|NCT04518995|141189577|SUPERIORITY||Risk Difference (RD)|0.04|STANDARD_ERROR_OF_MEAN|0.01||0.0006|TWO_SIDED|95.0|0.02|0.06||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 12||0.06|0.02|0.0006
70850731|NCT04518995|141189577|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.06|0.14||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 12||0.14|0.06|<0.0001
71016764|NCT03692078|141541614|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)"|Mean Difference (Net)|0.907|||<|0.0001|TWO_SIDED|95.0|0.675|1.14|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)"||1.140|.675|<.0001
71016765|NCT03692078|141541614|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)"|Mean Difference (Net)|-0.133||||0.8291|TWO_SIDED|95.0|-0.453|0.188|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)"||0.188|-0.453|.8291
71016766|NCT03692078|141541614|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)"|Mean Difference (Net)|-0.048||||0.9997|TWO_SIDED|95.0|-0.308|0.213|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)"||0.213|-0.308|0.9997
71016767|NCT03692078|141541614|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)"|Mean Difference (Net)|0.172||||0.5755|TWO_SIDED|95.0|-0.145|0.488|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)"||0.488|-0.145|0.5755
71016768|NCT03692078|141541614|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)"|Mean Difference (Net)|0.042||||0.9999|TWO_SIDED|95.0|-0.217|0.301|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)"||0.301|-0.217|0.9999
71016769|NCT03692078|141541616|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|2.629|||<|0.0001|TWO_SIDED|95.0|2.317|2.94|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)"||2.940|2.317|<.0001
71104980|NCT01968980|141717036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|22.8|||||TWO_SIDED|95.0|11.85|44.01||||||Week 52: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.||44.01|11.85|
71104981|NCT01968980|141717037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|200.8|||||TWO_SIDED|95.0|47.16|854.6||||||Week 12: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.||854.60|47.16|
71104982|NCT01968980|141717037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|228.0|||||TWO_SIDED|95.0|51.95|1000.39||||||Week 24: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.||1000.39|51.95|
71104983|NCT01968980|141717037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|259.9|||||TWO_SIDED|95.0|34.87|1937.06||||||Week 52: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.||1937.06|34.87|
71104984|NCT01474109|141717041|SUPERIORITY_OR_OTHER||NB-2 estimate of new DUs per patient|1.103||||0.706|TWO_SIDED|95.0|0.663|1.834|||negative binomial-2 regression (NB-2)||The estimated value corresponds to the treatment effect i.e. the ratio between the estimated number of new DUs in Macitentan 3 mg and in Placebo|||1.834|0.663|0.706
71104985|NCT01474109|141717041|SUPERIORITY_OR_OTHER||NB-2 estimate of new DUs per patient|1.268||||0.36|TWO_SIDED|95.0|0.763|2.106|||negative binomial-2 regression (NB-2)||The estimated value corresponds to the treatment effect i.e. the ratio between the estimated number of new DUs in Macitentan 10 mg and in Placebo|||2.106|0.763|0.360
71050274|NCT01941940|141606538|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-66: Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71050275|NCT01941940|141606538|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-66: Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71050276|NCT01941940|141606538|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-28: Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71050277|NCT01941940|141606538|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-28: Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71050278|NCT01941940|141606538|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-28: Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71050279|NCT01941940|141606539|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and CDAI at Week 2||||<0.0001
71050280|NCT01941940|141606539|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and CDAI at Week 24||||<0.0001
71050281|NCT01941940|141606539|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and CDAI at Week 52||||<0.0001
71050282|NCT01941940|141606540|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and SDAI at Week 2||||<0.0001
71104986|NCT01474109|141717042|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.875||||0.667|TWO_SIDED|95.0|0.477|1.606|||Chi-squared|||||1.606|0.477|0.6670
71050283|NCT01941940|141606540|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and SDAI at Week 24||||<0.0001
71050284|NCT01941940|141606540|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and SDAI at Week 52||||<0.0001
71050285|NCT01941940|141606541|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and SDAI at Week 2||||<0.0001
71050286|NCT01941940|141606541|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and SDAI at Week 24||||<0.0001
71050287|NCT01941940|141606541|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and SDAI at Week 52||||<0.0001
71050288|NCT01941940|141606542|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR20 at Week 2||||<0.0001
71050289|NCT01941940|141606542|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR50 at Week 2||||<0.0001
71050290|NCT01941940|141606542|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR70 at Week 2||||<0.0001
71050291|NCT01941940|141606542|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR20 at Week 24||||<0.0001
71050292|NCT01941940|141606542|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR50 at Week 24||||<0.0001
71050293|NCT01941940|141606542|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR70 at Week 24||||<0.0001
71050294|NCT01941940|141606542|SUPERIORITY_OR_OTHER|||||||0.0004|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR20 at Week 52||||0.0004
71050295|NCT01941940|141606542|SUPERIORITY_OR_OTHER|||||||0.0004|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR50 at Week 52||||0.0004
71104987|NCT01474109|141717042|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.832||||0.5518|TWO_SIDED|95.0|0.454|1.524|||Chi-squared|||||1.524|0.454|0.5518
71050296|NCT01941940|141606542|SUPERIORITY_OR_OTHER|||||||0.0004|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR70 at Week 52||||0.0004
71050297|NCT01941940|141606543|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and EULAR at Week 2||||<0.0001
71050298|NCT01941940|141606543|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and EULAR at Week 24||||<0.0001
71050299|NCT01941940|141606543|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and EULAR at Week 52||||<0.0001
71050300|NCT01941940|141606544|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR20 at Week 2||||<0.0001
71050301|NCT01941940|141606544|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR50 at Week 2||||<0.0001
71050302|NCT01941940|141606544|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR70 at Week 2||||<0.0001
71050303|NCT01941940|141606544|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR20 at Week 24||||<0.0001
71050304|NCT01941940|141606544|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR50 at Week 24||||<0.0001
71050305|NCT01941940|141606544|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR70 at Week 24||||<0.0001
71050306|NCT01941940|141606544|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR20 at Week 52||||<0.0001
71050307|NCT01941940|141606544|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR50 at Week 52||||<0.0001
71050308|NCT01941940|141606544|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR70 at Week 52||||<0.0001
71050309|NCT01941940|141606545|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and EULAR at Week 2||||<0.0001
71050310|NCT01941940|141606545|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and EULAR at Week 24||||<0.0001
71050311|NCT01941940|141606545|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and EULAR at Week 52||||<0.0001
71050312|NCT01941940|141606546|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR20 at Week 2||||<0.0001
71050313|NCT01941940|141606546|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR50 at Week 2||||<0.0001
71050314|NCT01941940|141606546|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR70 at Week 2||||<0.0001
71104988|NCT01474109|141717043|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.696||||0.3625|TWO_SIDED|95.0|0.319|1.518|||Chi-squared|||||1.518|0.319|0.3625
70941544|NCT02229396|141383842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.129||0.003|TWO_SIDED|95.0|-0.63|-0.13|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-0.13|-0.63|0.003
71016770|NCT03692078|141541616|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|2.632|||<|0.0001|TWO_SIDED|95.0|2.321|2.943|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)"||2.943|2.321|<.0001
71016771|NCT03692078|141541616|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|2.006|||<|0.0001|TWO_SIDED|95.0|1.714|2.298|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)"||2.298|1.714|<.0001
71050315|NCT01941940|141606546|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR20 at Week 24||||<0.0001
71050316|NCT01941940|141606546|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR50 at Week 24||||<0.0001
71050317|NCT01941940|141606546|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR70 at Week 24||||<0.0001
71050318|NCT01941940|141606546|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR20 at Week 52||||<0.0001
71050319|NCT01941940|141606546|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR50 at Week 52||||<0.0001
71050320|NCT01941940|141606546|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR70 at Week 52||||<0.0001
71050321|NCT01941940|141606547|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and EULAR at Week 2||||<0.0001
71050322|NCT01941940|141606547|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and EULAR at Week 24||||<0.0001
71050323|NCT01941940|141606547|SUPERIORITY_OR_OTHER|||||||0.0016|||||||ANOVA|||Analysis for association between SDAI and EULAR at Week 52||||0.0016
71050324|NCT01941940|141606550|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71050325|NCT01941940|141606550|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71050326|NCT01941940|141606550|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71050327|NCT01941940|141606551|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71050328|NCT01941940|141606551|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
70941545|NCT02229396|141383842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.127|<|0.001|TWO_SIDED|95.0|-0.84|-0.34|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-0.34|-0.84|<0.001
71050329|NCT01941940|141606551|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71050330|NCT01941940|141606552|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71050331|NCT01941940|141606552|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
70941546|NCT02229396|141383843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.406|<|0.001|TWO_SIDED|95.0|-2.79|-1.2|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-1.20|-2.79|<0.001
71050332|NCT01941940|141606552|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71050333|NCT01941940|141606553|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71050334|NCT01941940|141606553|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71050335|NCT01941940|141606553|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71050336|NCT01941940|141606555|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71050337|NCT01941940|141606555|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71050338|NCT01941940|141606555|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71016772|NCT03692078|141541616|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|2.143|||<|0.0001|TWO_SIDED|95.0|1.847|2.44|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)"||2.440|1.847|<.0001
71016773|NCT03692078|141541616|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|1.987|||<|0.0001|TWO_SIDED|95.0|1.69|2.284|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)"||2.284|1.690|<.0001
71016774|NCT03692078|141541616|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|2.261|||<|0.0001|TWO_SIDED|95.0|1.964|2.559|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)"||2.559|1.964|<.0001
71016775|NCT03692078|141541616|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|-0.263||||0.1658|TWO_SIDED|95.0|-0.635|0.109|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)"||0.109|-0.635|0.1658
71016776|NCT03692078|141541616|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|-0.659||||0.0007|TWO_SIDED|95.0|-1.036|-0.282|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)"||-0.282|-1.036|0.0007
71016777|NCT03692078|141541616|NON_INFERIORITY|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|-0.302||||0.1055|TWO_SIDED|95.0|-0.667|0.064|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)"||0.064|-0.667|0.1055
71016778|NCT03692078|141541616|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|-0.243||||0.204|TWO_SIDED|95.0|-0.617|0.132|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)"||0.132|-0.617|0.2040
71016779|NCT03692078|141541616|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|-0.244||||0.1829|TWO_SIDED|95.0|-0.603|0.116|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)"||0.116|-0.603|0.1829
71016780|NCT03692078|141541616|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|-0.248||||0.1801|TWO_SIDED|95.0|-0.612|0.115|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)"||0.115|-0.612|0.1801
71050339|NCT01941940|141606556|SUPERIORITY_OR_OTHER|||||||0.0045|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||0.0045
70930492|NCT04602611|141359542|SUPERIORITY|||||||0.88||||||The a priori threshold for statistical significance was 0.025.|Fisher Exact|No adjustments were made in this analysis.||The study was designed with co-primary objectives evaluating acute care utilization (ACU) and 6-month OS rate. Power/sample size were calculated based on the OS objective. The overall type I error rate was alpha=0.05; the co-primary objectives were powered at the 2-sided alpha=0.025 significance level. Three hundred evaluable subjects would have provided \>=93% power to detect a 20% reduction in ACU (assuming there were 6 ACUs per year in SOC arm). The study did not achieve targeted enrollment.|The proportions of evaluable subjects surviving at 6 months were analyzed in a 2x2 contingency table using Fisher's Exact test. In the SOC arm, 52/87(60%) evaluable subjects were alive at 6 months and 35/87 (40%) were not. In the ONN + SOC arm, 58/95 (61%) evaluable subjects were alive at 6 months and 37/95 (39%) were not. The p-value estimated using Fisher's Exact test on this 2x2 contingency table was p=0.88.|||0.88
70930493|NCT04602611|141359543|SUPERIORITY|||||||0.74||||||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Fisher Exact|No adjustments were made in this analysis.|||The proportions of evaluable subjects surviving at 12 months were analyzed in a 2x2 contingency table using Fisher's Exact test. In the SOC arm, 23/87(26%) evaluable subjects were alive at 12 months and 64/87(74%) were not. In the ONN + SOC arm, 28/95 (29%) evaluable subjects were alive at 6 months and 67/95 (71%) were not. The p-value estimated using Fisher's Exact test on this 2x2 contingency table was p=0.74.|||0.74
70930494|NCT04602611|141359544|SUPERIORITY||Coefficient of negative binomial model|0.1574||||0.57|TWO_SIDED|95.0|-0.3905|0.7054||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Regression, Negative binomial|Model was estimated without adjustments (sole covariate was treatment; coefficient was the estimated treatment effect) using 180 degrees of freedom.|The estimated coefficient was associated with Oncology Nurse Navigation with reference to Standard of Care.|||0.7054|-0.3905|0.57
71016781|NCT03692078|141541616|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.622||||0.0391|TWO_SIDED|95.0|-1.225|-0.019|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.019|-1.225|0.0391
71016782|NCT03692078|141541616|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.489||||0.1864|TWO_SIDED|95.0|-1.096|0.119|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||0.119|-1.096|0.1864
71016783|NCT03692078|141541616|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.642||||0.031|TWO_SIDED|95.0|-1.246|-0.037|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.037|-1.246|0.0310
71016784|NCT03692078|141541616|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)"|Mean Difference (Net)|-0.642||||0.031|TWO_SIDED|95.0|-1.246|-0.037|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)"||-0.037|-1.246|0.0310
71016785|NCT03692078|141541616|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.891|||<|0.0001|TWO_SIDED|95.0|-3.58|-2.202|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.202|-3.580|<.0001
71050340|NCT01941940|141606556|SUPERIORITY_OR_OTHER|||||||0.1992|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||0.1992
71050341|NCT00513682|141606564|SUPERIORITY_OR_OTHER|||||||0.0013||95.0|||||t-test, 1 sided|||||||0.0013
71050342|NCT00513682|141606565|SUPERIORITY_OR_OTHER|||||||0.0009||95.0|||||t-test, 1 sided|||||||0.0009
71104989|NCT01474109|141717043|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.9362|TWO_SIDED|95.0|0.498|2.133|||Chi-squared|||||2.133|0.498|0.9362
71104990|NCT01474109|141717044|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.863|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|||||0.2|-0.1|0.863
71104991|NCT01474109|141717044|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.649|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.649
71104992|NCT01474109|141717045|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.456|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.456
71104993|NCT01474109|141717045|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.44|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.440
70930495|NCT04602611|141359545|SUPERIORITY||Hazard Ratio (HR)|0.864||||0.45|TWO_SIDED|95.0|0.57|1.309||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Log Rank|Unadjusted log-rank test|The estimated hazard ratio was associated with Oncology Nurse Navigation with reference to Standard of Care; the model was estimated without adjustments (the sole covariate was treatment).|||1.309|0.570|0.45
71016786|NCT03692078|141541616|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-3.291|||<|0.0001|TWO_SIDED|95.0|-3.985|-2.597|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.597|-3.985|<.0001
71016787|NCT03692078|141541616|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.93|||<|0.0001|TWO_SIDED|95.0|-3.605|-2.255|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.255|-3.605|<.0001
71016788|NCT03692078|141541616|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-2.875|||<|0.0001|TWO_SIDED|95.0|-3.559|-2.19|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.190|-3.559|<.0001
71016789|NCT03692078|141541616|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.25|||<|0.0001|TWO_SIDED|95.0|1.604|2.896|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||2.896|1.604|<.0001
71016790|NCT03692078|141541616|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.391|||<|0.0001|TWO_SIDED|95.0|1.737|3.046|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||3.046|1.737|<.0001
71016791|NCT03692078|141541616|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.231|||<|0.0001|TWO_SIDED|95.0|1.582|2.879|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||2.879|1.582|<.0001
71016792|NCT03692078|141541616|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.509|||<|0.0001|TWO_SIDED|95.0|1.857|3.162|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||3.162|1.857|<.0001
71016793|NCT03692078|141541616|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.019||||1|TWO_SIDED|95.0|-0.743|0.705|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.705|-0.743|1.0000
71104994|NCT01474109|141717046|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.464|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||||0.1|-0.3|0.464
71104995|NCT01474109|141717046|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.342|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||||0.1|-0.3|0.342
70941547|NCT02229396|141383843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.12|-0.55|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-0.55|-2.12|<0.001
70850732|NCT04518995|141189577|SUPERIORITY||Risk Difference (RD)|0.19|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.15|0.23||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 24||0.23|0.15|<0.0001
71050343|NCT01121666|141606576|NON_INFERIORITY_OR_EQUIVALENCE|This study was powered to test equivalence using a two one-sided test (TOST) of the number of oocytes retrieved with a power of 90%, an alpha error of 2.5% and a pre-determined clinical equivalence margin of +/-2.9 oocytes for the relevant population.||||||0.0003|TWO_SIDED|||||This study was powered to test equivalence using a two one-sided test (TOST) with a power of 90%, an alpha error of 2.5% and a pre-determined clinical equivalence margin of +/-2.9 oocytes for the relevant population.|Shuirmann's TOST|||This study was powered to test equivalence using a two one-sided test (TOST) of the number of oocytes retrieved.||||0.0003
71050344|NCT01121666|141606577|SUPERIORITY_OR_OTHER|||||||0.2357|TWO_SIDED|||||Follicles of 12 mm|Wilcoxon (Mann-Whitney)|||||||0.2357
71050345|NCT01121666|141606577|SUPERIORITY_OR_OTHER|||||||0.1395|TWO_SIDED|||||Follicles of 15 mm|Wilcoxon (Mann-Whitney)|||||||0.1395
71050346|NCT01121666|141606577|SUPERIORITY_OR_OTHER|||||||0.3992|TWO_SIDED|||||Follicles of 17 mm|Wilcoxon (Mann-Whitney)|||||||0.3992
71050347|NCT01121666|141606579|SUPERIORITY_OR_OTHER|||||||0.9638|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.9638
71050348|NCT01121666|141606584|SUPERIORITY_OR_OTHER|||||||0.8926|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.8926
71050349|NCT01121666|141606591|NON_INFERIORITY_OR_EQUIVALENCE|This study was powered to test equivalence using a two one-sided test (TOST) of the number of oocytes retrieved with a power of 90%, an alpha error of 2.5% and a pre-determined clinical equivalence margin of +/-2.9 oocytes for the relevant population.||||||0.0003|TWO_SIDED||||||Shuirmann's TOST|||||||0.0003
71050350|NCT03176459|141606599|SUPERIORITY||LSM treatment difference|-16.5||||0.0117|TWO_SIDED|95.0|-30.8|-2.2|||ANCOVA|||||-2.2|-30.8|0.0117
71050351|NCT03176459|141606600|NON_INFERIORITY|Pre-specified non-inferiority margin of 36|LSM treatment difference (SE)|-30.6||||0.002|TWO_SIDED|95.0|-75.9|14.7|||ANCOVA|||||14.7|-75.9|0.0020
71050352|NCT03176459|141606601|SUPERIORITY||Odds Ratio (OR)|3.51||||0.0012|TWO_SIDED|95.0|1.557|7.906|||LSM probability from logistic regression|||||7.906|1.557|0.0012
71050353|NCT03176459|141606602|SUPERIORITY||Least squares treatment difference|-3.2||||0.0543|TWO_SIDED||||||ANCOVA|||||||.0543
71050354|NCT03176459|141606603|SUPERIORITY||Least squares treatment difference|-11.4||||0.0096|ONE_SIDED||||||ANCOVA|||||||.0096
71050355|NCT03176459|141606604|SUPERIORITY||Least squares treatment difference|-22.4||||0.0175|TWO_SIDED||||||ANCOVA|||||||.0175
71050356|NCT03176459|141606605|SUPERIORITY||Least squares treatment difference|-19.6||||0.0542|TWO_SIDED||||||ANCOVA|||||||.0542
70850733|NCT04518995|141189577|SUPERIORITY||Risk Difference (RD)|0.3|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.24|0.37||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 24||0.37|0.24|<0.0001
71050357|NCT03176459|141606606|SUPERIORITY|||||||0.7536|||||||Regression, Cox|||||||0.7536
71050358|NCT03176459|141606607|SUPERIORITY||Odds Ratio (OR)|1.14||||0.3609|TWO_SIDED||||||Regression, Logistic|||||||0.3609
71050359|NCT00759902|141606629|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|123.0||||||90.0|112.9|134.1|||ANOVA|log-transformation||||134.1|112.9|
71050360|NCT00759902|141606631|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|101.7||||||90.0|98.5|104.9|||ANOVA|log-transformation||||104.9|98.5|
71050361|NCT00759902|141606632|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|102.9||||||90.0|99.3|106.5|||ANOVA|log-transformation||||106.5|99.3|
71050362|NCT05071313|141606654|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after vaccination with fluzone, using a non-inferiority margin of 1.5 for the GMT ratio (Group 2/Group 1).|Geometric Mean Ratio|1.01|||||TWO_SIDED|95.0|0.89|1.14||||||A/Victoria||1.14|0.89|
71050363|NCT05071313|141606654|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after vaccination with fluzone, using a non-inferiority margin of 1.5 for the GMT ratio (Group 2/Group 1).|Geometric Mean Ratio|1.11|||||TWO_SIDED|95.0|0.97|1.28||||||A/Tasmania||1.28|0.97|
71117599|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
71016794|NCT03692078|141541616|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.411||||0.5639|TWO_SIDED|95.0|-1.142|0.32|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.320|-1.142|0.5639
71016795|NCT03692078|141541616|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.058||||1|TWO_SIDED|95.0|-0.771|0.656|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.656|-0.771|1.0000
71016796|NCT03692078|141541616|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.006||||1|TWO_SIDED|95.0|-0.721|0.732|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.732|-0.721|1.0000
71016797|NCT03692078|141541618|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.691|||<|0.0001|TWO_SIDED|95.0|2.519|2.863|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||2.863|2.519|<.0001
71050364|NCT05071313|141606654|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after vaccination with fluzone, using a non-inferiority margin of 1.5 for the GMT ratio (Group 2/Group 1).|Geometric Mean Ratio|0.91|||||TWO_SIDED|95.0|0.79|1.05||||||B/Washington||1.05|0.79|
71050365|NCT05071313|141606654|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after vaccination with fluzone, using a non-inferiority margin of 1.5 for the GMT ratio (Group 2/Group 1).|Geometric Mean Ratio|0.97||||||95.0|0.85|1.1||||||B/Phuket||1.10|0.85|
71050366|NCT01461226|141606712|OTHER|Mixed models analysis|mixed models|0.04|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
71050367|NCT01461226|141606712|OTHER||mixed models|0.24||||0.64|TWO_SIDED|||||Baseline difference between groups|Mixed Models Analysis|||||||0.64
71050368|NCT01461226|141606712|OTHER|Mixed models|Slope|0.27||||0.6|TWO_SIDED||||||Mixed Models Analysis|||||||0.60
71050369|NCT01461226|141606712|OTHER|mixed models|mixed models|4.2||||0.04|TWO_SIDED||||||Mixed Models Analysis|||change after 10 months between groups||||0.04
71050370|NCT04763564|141606715|SUPERIORITY||||||<|0.03||||||A priori threshold for significance was \< 0.05. Significance level liraglutide vs. placebo in percent reduction of bowel frequency at week 4 vs. baseline.|Mixed Models Analysis|||The 2 treatment modalities, Liraglutide and Placebo, were compared. A repeated-measures mixed model was fitted to the data, with treatment (liraglutide or placebo), period, and treatment sequence as fixed effects and the repeated measures within the subject as a random effect.||||<0.03
71050371|NCT04763564|141606718|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||The 2 treatment modalities, Liraglutide and Placebo, were compared. A repeated-measures mixed model was fitted to the data, with treatment (liraglutide or placebo), period, and treatment sequence as fixed effects and the repeated measures within the subject as a random effect.||||0.01
71050372|NCT00852969|141606765|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.69||||0.71|TWO_SIDED|95.0|-10.79|7.41|||t-test, 2 sided|||||7.41|-10.79|0.71
71050373|NCT00852969|141606766|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.48||||0.29|TWO_SIDED|95.0|-7.2|2.24|||t-test, 2 sided|||||2.24|-7.20|0.29
71050374|NCT02440022|141606795|SUPERIORITY|||||||0.0562|||||||Kaplan-Meier|||||||0.0562
71050375|NCT02440022|141606796|NON_INFERIORITY|Where δ = 10% is the non-inferiority margin, which is the range of difference that is considered not clinically important. A non-inferiority Farrington and Manning Test was used to test the primary safety hypothesis. The test is successful if the one-sided p-value is less than 0.025. In addition to the p-value of the test, the confidence intervals of the rate in each group and the difference between the two groups is calculated.||||||0.002|||||||Binary Analysis|||"H0: The primary safety rate p1 in the DCB treatment group through 30 days post index procedure is inferior to that p2 of the PTA treatment group. (i.e. p1 ≤ p2 - δ)~H1: The primary safety rate p1 in the DCB treatment group through 30 days post index procedure is non-inferior to that p2 of the PTA treatment group. (i.e. p1 \> p2 - δ)"||||0.002
71050376|NCT02440022|141606802|OTHER|||||||0.716||||||P-value was type 3 test of the interaction of treatment group and pre-dilation balloon type.|Regression, Cox|||||||0.7160
71050377|NCT02358343|141606822|SUPERIORITY|||||||0.77||||||a priori threshold for significance is 0.05.|Likelihood Ratio Test|Likelihood ratio test obtained from logistic regression analysis adjusting for site||||||0.77
71016798|NCT03692078|141541618|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.718|||<|0.0001|TWO_SIDED|95.0|2.546|2.89|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||2.890|2.546|<.0001
71016799|NCT03692078|141541618|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.415|||<|0.0001|TWO_SIDED|95.0|2.252|2.577|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||2.577|2.252|<.0001
70850734|NCT04518995|141189578|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.22||0.001|TWO_SIDED|95.0|0.3|1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.2|0.3|0.0010
71016800|NCT03692078|141541618|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.44|||<|0.0001|TWO_SIDED|95.0|2.276|2.603|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||2.603|2.276|<.0001
71016801|NCT03692078|141541618|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.583|||<|0.0001|TWO_SIDED|95.0|2.417|2.748|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||2.748|2.417|<.0001
71016802|NCT03692078|141541618|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.591|||<|0.0001|TWO_SIDED|95.0|2.426|2.757|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||2.757|2.426|<.0001
71016803|NCT03692078|141541618|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.107|||<|0.0001|TWO_SIDED|95.0|0.901|1.314|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||1.314|0.901|<.0001
71016804|NCT03692078|141541618|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.017|||<|0.0001|TWO_SIDED|95.0|0.81|1.225|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||1.225|0.810|<.0001
71016805|NCT03692078|141541618|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.828|||<|0.0001|TWO_SIDED|95.0|1.624|2.031|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||2.031|1.624|<.0001
71016806|NCT03692078|141541618|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.782|||<|0.0001|TWO_SIDED|95.0|1.577|1.988|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||1.988|1.577|<.0001
71077877|NCT02913105|141664398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.0744|TWO_SIDED|90.0|0.89|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 28||1.00|0.89|0.0744
71077878|NCT02913105|141664398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.99||||0.8365|TWO_SIDED|90.0|0.93|1.06|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 42||1.06|0.93|0.8365
71077879|NCT02913105|141664398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.98||||0.6091|TWO_SIDED|90.0|0.92|1.05|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 56||1.05|0.92|0.6091
71077880|NCT02913105|141664398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.3621|TWO_SIDED|90.0|0.9|1.03|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 84||1.03|0.90|0.3621
70850735|NCT04518995|141189578|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|0.6|1.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.6|0.6|<0.0001
71077881|NCT02913105|141664398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.97||||0.5031|TWO_SIDED|90.0|0.91|1.04|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 112 (EOS)||1.04|0.91|0.5031
71050378|NCT02358343|141606823|SUPERIORITY||Mean Difference (Final Values)|-1.84||||0.035|TWO_SIDED|95.0|-3.54|-0.13||a priori threshold for significance is 0.05.|Wald Test|The Wald test is for the week 12 comparative treatment effect from a longitudinal model of QIDS-C adjusting for clinical site.|The week 12 mean difference estimated from the longitudinal model is the difference between antidepressant drug therapy (drug) and the cognitive behavioral therapy (CBT) at 12 weeks, (drug - CBT).|All participants randomized to treatment (N=120) were included in the pre-specified longitudinal model of QIDS-C used to estimate comparative treatment effect at 12 weeks (primary outcome). The model adjustment for clinical site and included baseline, 6 week and 12 week QIDS-C scores. Week 0 (baseline) and week 6 measurements are not pre-specified primary or secondary outcomes. The Observational Cohort arm was not included in the analysis.||-0.13|-3.54|0.035
71050379|NCT02358343|141606824|SUPERIORITY|||||||0.96||||||a priori threshold for significance is 0.05.|Likelihood Ratio Test|Likelihood Ratio Test from logistic regression analysis adjusting for clinical site.||||||0.96
71050380|NCT02358343|141606825|SUPERIORITY||Mean Difference (Final Values)|-3.7|||||TWO_SIDED|95.0|-7.4|-0.02|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||-0.02|-7.4|
71050381|NCT02358343|141606826|SUPERIORITY||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-3.1|0.8|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||0.8|-3.1|
71050382|NCT02358343|141606827|SUPERIORITY||Mean Difference (Final Values)|-3.1|||||TWO_SIDED|95.0|-6.2|-0.1|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||-0.1|-6.2|
71050383|NCT02358343|141606828|SUPERIORITY||Mean Difference (Final Values)|10.2|||||TWO_SIDED|95.0|1.3|19.0|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||19.0|1.3|
71050384|NCT02358343|141606829|SUPERIORITY||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.2|1.4|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||1.4|-0.2|
71050385|NCT02358343|141606830|SUPERIORITY||Mean Difference (Final Values)|2.6|||||TWO_SIDED|95.0|0.1|5.1|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||5.1|0.1|
71050386|NCT02358343|141606831|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.5|0.5|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||0.5|-0.5|
71050387|NCT02358343|141606833|SUPERIORITY||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.5|0.7|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||0.7|-0.5|
71050388|NCT02358343|141606834|SUPERIORITY||Risk Ratio (RR)|0.78|||||TWO_SIDED|95.0|0.55|1.1|||||The mean difference estimate is from a negative binomial model adjusted for clinical site. It is the rate of sessions skipped/shortened in the Drug group (numerator) compared to CBT (denominator).|||1.10|0.55|
71050389|NCT02358343|141606835|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.54|0.34|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||0.34|-0.54|
71050390|NCT02358343|141606836|SUPERIORITY||Mean Difference (Final Values)|0.25|||||TWO_SIDED|95.0|-0.25|0.75|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||0.75|-0.25|
71050391|NCT01951885|141606886|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|47 patients per arm were needed to detect a 25% improvement in mucositis based on a one-sided test with 5% significance and 80% power.||||||0.05
71050392|NCT01951885|141606889|NON_INFERIORITY|Cumulative incidence methods are compared using the Gray test with a p-value \<0.05|||||<|0.05|||||||Log Rank|||||||<0.05
71050393|NCT01951885|141606890|NON_INFERIORITY|Hospital stay will be compared between groups using the Wilcoxon rank sum test with a p value of 0.05.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71050394|NCT01951885|141606891|NON_INFERIORITY|TPN use will be compared using the Chi-square test.|||||<|0.05|||||||Chi-squared|||||||<0.05
71050395|NCT01951885|141606892|NON_INFERIORITY|Overall survival was estimated using the Kaplan-Meier method and compared between patients receiving Tac/MTX versus Tac/mini-MTX/MMF using the log-rank test|||||<|0.05|||||||Log Rank|||||||<0.05
71050396|NCT01951885|141606893|NON_INFERIORITY|Progression-free survival was estimated using the Kaplan-Meier method and compared between patients receiving Tac/MTX versus Tac/mini-MTX/MMF using the log-rank test|||||<|0.05|||||||Log Rank|||||||<0.05
71050397|NCT01951885|141606896|NON_INFERIORITY|Infusion times will be compared using the Wilcoxon rank sum test|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71050398|NCT01951885|141606897|NON_INFERIORITY|100-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Gray Test|||||||<0.05
71050399|NCT01951885|141606898|NON_INFERIORITY|100-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Gray Test|||||||<0.05
71050400|NCT01951885|141606899|NON_INFERIORITY|100-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Chi-squared|||||||<0.05
71050401|NCT01951885|141606900|NON_INFERIORITY|100-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Gray Test|||||||<0.05
71050402|NCT01951885|141606902|NON_INFERIORITY|180-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Gray Test|||||||<0.05
71050403|NCT01951885|141606903|NON_INFERIORITY|180-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Gray Test|||||||<0.05
71050404|NCT01951885|141606904|NON_INFERIORITY|180-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Gray Test|||||||<0.05
71050405|NCT00866658|141606906|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.88|STANDARD_ERROR_OF_MEAN|0.118|<|0.0001|TWO_SIDED|95.0|-1.116|-0.65||Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance(ANCOVA)included treatment arms, randomization strata of screening HbA1c (\<8.0, \>=8.0%),sulfonylurea use (yes, no), country as fixed effects, baseline HbA1c as covariate.|ANCOVA|||To detect a difference of 0.5% in change from baseline to Week 24 in HbA1c between lixisenatide and placebo, 145 patients in each arm would provide a power of 90% assuming common standard deviation of 1.3% with a 2-sided t test at 5% significance level.||-0.650|-1.116|<0.0001
71050406|NCT01276301|141606918|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|102.95|STANDARD_ERROR_OF_MEAN|6.5|||TWO_SIDED|90.0|98.87|107.02|||ANOVA|Based on ANOVA with fixed terms for sequence, period, treatment and random term for subject within sequence.|Standard error of the mean is actually the Intra-Individual geometric coefficient of variation (gCV).|Ratio calculated as empa plus verapamil divided by empa||107.02|98.87|
71050407|NCT01276301|141606919|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|92.39|STANDARD_ERROR_OF_MEAN|12.7|||TWO_SIDED|90.0|85.38|99.97|||ANOVA|Based on ANOVA with fixed terms for sequence, period, treatment and random term for subject within sequence.|Standard error of the mean is actually the Intra-Individual geometric coefficient of variation (gCV).|Ratio calculated as empa plus verapamil divided by empa||99.97|85.38|
71050408|NCT01276301|141606920|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|102.77|STANDARD_ERROR_OF_MEAN|6.2|||TWO_SIDED|90.0|98.87|106.83|||ANOVA|Based on ANOVA with fixed terms for sequence, period, treatment and random term for subject within sequence.|Standard error of the mean is actually the Intra-Individual geometric coefficient of variation (gCV).|Ratio calculated as empa plus verapamil divided by empa||106.83|98.87|
71050409|NCT01462318|141606937|SUPERIORITY_OR_OTHER||ratio|1.015|||||TWO_SIDED|90.0|0.894|1.153|||||test/reference = midazolam+DAC HYP/midazolam|Pairwise comparison: midazolam. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.153|0.894|
71050410|NCT01462318|141606937|SUPERIORITY_OR_OTHER||ratio|1.005|||||TWO_SIDED|90.0|0.951|1.063|||||test/reference = S-warfarin+DAC HYP/S-warfarin|Pairwise comparison: S-warfarin. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.063|0.951|
71050411|NCT01462318|141606937|SUPERIORITY_OR_OTHER||ratio|0.996|||||TWO_SIDED|90.0|0.88|1.127|||||test/reference = omeprazole+DAC HYP/omeprazole|Pairwise comparison: omeprazole. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.127|0.880|
71050412|NCT01462318|141606937|SUPERIORITY_OR_OTHER||ratio|1.032|||||TWO_SIDED|90.0|0.93|1.145|||||test/reference = caffeine+DAC HYP/caffeine|Pairwise comparison: caffeine. Based on linear mixed model with fixed effect for treatment and random effect for participants. Excludes participants with high predose concentration (\>5% of maximum observed concentration \[Cmax\]).||1.145|0.930|
71050413|NCT01462318|141606938|SUPERIORITY_OR_OTHER||ratio|1.012|||||TWO_SIDED|90.0|0.764|1.342|||||test/reference = dextromethorphan+DAC HYP/dextromethorphan|Pairwise comparison: dextromethorphan. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.342|0.764|
71050414|NCT01462318|141606946|SUPERIORITY_OR_OTHER||ratio|1.079|||||TWO_SIDED|90.0|0.912|1.276|||||test/reference = midazolam+DAC HYP/midazolam|Pairwise comparison: midazolam. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.276|0.912|
71050415|NCT01462318|141606946|SUPERIORITY_OR_OTHER||ratio|1.012|||||TWO_SIDED|90.0|0.952|1.075|||||test/reference = S-warfarin+DAC HYP/S-warfarin|Pairwise comparison: S-warfarin. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.075|0.952|
71050416|NCT01462318|141606946|SUPERIORITY_OR_OTHER||ratio|1.058|||||TWO_SIDED|90.0|0.804|1.392|||||test/reference = omeprazole+DAC HYP/omeprazole|Pairwise comparison: omeprazole. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.392|0.804|
71104996|NCT02589938|141717047|SUPERIORITY|Repeated measures analysis of covariance (RMANCOVA) models were constructed to assess differences in each outcome adjusting for baseline outcome value, group, time, and group by time interaction assuming an unstructured covariance. The primary objective was assessed using a linear contrast of group effect at 4 weeks||||||0.0167|||||||ANCOVA|||The primary endpoint was to determine whether true acupuncture (TA) was more effective than sham acupuncture (SA) or standard oral hygiene (SOH) at treating xerostomia as assessed by the xerostomia questionnaire (XQ) at Week 4. The study was powered to detect a difference of 10 points with an assumed standard deviation (SD)=16 between each pair of groups on XQ.This assumed a t-test with a two-sided significance level of 0·0133 and 84% power with 20% dropout.||||0.0167
71050417|NCT01462318|141606946|SUPERIORITY_OR_OTHER||ratio|1.116|||||TWO_SIDED|90.0|1.005|1.238|||||test/reference = caffeine+DAC HYP/caffeine|Pairwise comparison: caffeine. Based on linear mixed model with fixed effect for treatment and random effect for participants. Excludes participants with high predose concentration (\>5% of Cmax).||1.238|1.005|
71050418|NCT01462318|141606948|SUPERIORITY_OR_OTHER||ratio|0.878|||||TWO_SIDED|90.0|0.697|1.105|||||test/reference = omeprazole+DAC HYP/omeprazole|Pairwise comparison: omeprazole. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.105|0.697|
71050419|NCT04442490|141606987|SUPERIORITY||Least Squares (LS) Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.0141|TWO_SIDED|95.0|-3.1|-0.3|||MMRM||Model used was the MMRM with treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|||-0.3|-3.1|0.0141
71050420|NCT04442490|141606988|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.1193|TWO_SIDED|95.0|-0.4|0.0|||MMRM||Model used was the MMRM with treatment (SAGE-217 or placebo), baseline CGI-S score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|||0.0|-0.4|0.1193
71104997|NCT02521285|141717050|SUPERIORITY|||||||0.343|||||||t-test, 2 sided|||||||0.343
71104998|NCT02521285|141717050|SUPERIORITY|||||||0.149|||||||t-test, 2 sided|||||||0.149
71104999|NCT02521285|141717051|SUPERIORITY|||||||0.878|||||||t-test, 2 sided|||||||0.878
71105000|NCT02521285|141717052|SUPERIORITY|||||||0.382|||||||t-test, 2 sided|||||||0.382
71105001|NCT02521285|141717052|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
71105002|NCT02521285|141717053|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||||||0.53
71105003|NCT02521285|141717053|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
70930496|NCT04602611|141359546|SUPERIORITY||Coefficient of negative binomial model|-0.4194||||0.21|TWO_SIDED|95.0|-1.0763|0.2374||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Regression, Negative binomial|Model was estimated without adjustments (sole covariate was treatment; coefficient was the estimated treatment effect) using 180 degrees of freedom.|The estimated coefficient was associated with Oncology Nurse Navigation with reference to Standard of Care.|||0.2374|-1.0763|0.21
70930497|NCT04602611|141359547|SUPERIORITY||Odds Ratio (OR)|3.28|||<|0.01|TWO_SIDED|95.0|1.75|6.15||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Regression, Logistic|Model was estimated without adjustments (the sole covariate was treatment).|The estimated odds ratio was associated with Oncology Nurse Navigation with reference to Standard of Care.|||6.15|1.75|<0.01
71050421|NCT04442490|141606989|SUPERIORITY||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.52|<|0.0001|TWO_SIDED|95.0|-4.0|-2.0|||MMRM||Model used was the MMRM with treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from baseline at Day 3||-2.0|-4.0|<0.0001
71050422|NCT04442490|141606989|SUPERIORITY||LS Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.61|<|0.0001|TWO_SIDED|95.0|-3.8|-1.4|||MMRM||Model used was the MMRM with treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from baseline at Day 8||-1.4|-3.8|<0.0001
70930498|NCT04602611|141359548|SUPERIORITY||Slope|-2.6939||||0.11|TWO_SIDED|95.0|-5.9538|0.5659||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Regression, Linear|Model was estimated without adjustments (sole covariate was treatment; slope was the estimated treatment effect) using 180 degrees of freedom.|The estimated slope was associated with Oncology Nurse Navigation with reference to Standard of Care.|||0.5659|-5.9538|0.11
70930499|NCT04602611|141359549|SUPERIORITY||Slope|0.1197||||0.09|TWO_SIDED|95.0|-0.0315|0.4378||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Regression, Linear|This univariate model was not adjusted for other covariates; this model was estimated using 84 degrees of freedom.|The estimated slope was associated with Oncology Nurse Navigation with reference to Standard of Care.|||0.4378|-0.0315|0.09
71050423|NCT04442490|141606989|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.76||0.2344|TWO_SIDED|95.0|-2.4|0.6|||MMRM||Model used was the MMRM with treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from baseline at Day 42||0.6|-2.4|0.2344
71050424|NCT04442490|141606990|SUPERIORITY||Odds Ratio (OR)|1.4||||0.0599|TWO_SIDED|95.0|0.99|1.98|||Generalized Estimating Equation Model|||Day 15|Model used is a GEE for binary response model, with factors for treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction with Unstructured covariance structure. Odds ratio was the estimate of the odds of having HAM-D response for participants treated with SAGE-217 relative to that for participants treated with placebo.|1.98|0.99|0.0599
71050425|NCT04442490|141606990|SUPERIORITY||Odds Ratio (OR)|1.36||||0.0889|TWO_SIDED|95.0|0.95|1.94|||GEE Model|||Day 42|Model used is a GEE for binary response model, with factors for treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction with Unstructured covariance structure.Odds ratio was the estimate of the odds of having HAM-D response for participants treated with SAGE-217 relative to that for participants treated with placebo.|1.94|0.95|0.0889
71050426|NCT04442490|141606991|SUPERIORITY||Odds Ratio (OR)|1.13||||0.5495|TWO_SIDED|95.0|0.76|1.66|||GEE Model|||Day 15|Model used is GEE for binary response model, with factors for treatment, baseline HAM-D total score, antidepressant use at baseline, assessment time point, and time point-by-treatment interaction with Unstructured covariance structure. Odds ratio was the estimate of the odds of having HAM-D remission for participants treated with SAGE-217 relative to that for participants treated with placebo.|1.66|0.76|0.5495
71050427|NCT04442490|141606991|SUPERIORITY||Odds Ratio (OR)|1.09||||0.679|TWO_SIDED|95.0|0.74|1.6|||GEE Model|||Day 42|Model used is GEE for binary response model, with factors for treatment, baseline HAM-D total score, antidepressant use at baseline, assessment time point, and time point-by-treatment interaction with Unstructured covariance structure. Odds ratio was the estimate of the odds of having HAM-D remission for participants treated with SAGE-217 relative to that for participants treated with placebo.|1.60|0.74|0.6790
71050428|NCT04442490|141606992|SUPERIORITY||Odds Ratio (OR)|1.52||||0.0191|TWO_SIDED|95.0|1.07|2.16|||GEE Model|||Placebo, SAGE-217|Model used was a GEE for binary response model, with factors for treatment, CGI-S baseline score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction with Unstructured covariance structure. Odds ratio was the estimate of the odds of having CGI-I response for participants treated with SAGE-217 relative to that for participants treated with placebo.|2.16|1.07|0.0191
71050429|NCT04442490|141606993|SUPERIORITY||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.05||0.0238|TWO_SIDED|95.0|-4.4|-0.3|||MMRM||Model used was the MMRM with treatment (SAGE-217/placebo), baseline MADRS total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure|Placebo, SAGE-217||-0.3|-4.4|0.0238
71105004|NCT02521285|141717054|SUPERIORITY|||||||0.234|||||||t-test, 2 sided|||||||0.234
71105005|NCT02521285|141717054|SUPERIORITY|||||||0.442|||||||t-test, 2 sided|||||||0.442
70850736|NCT04518995|141189578|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|1.2|2.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2.2|1.2|<0.0001
70930500|NCT04631016|141359550|OTHER||LS Mean Difference|0.024||||0.216|TWO_SIDED|80.0|-0.015|0.063|||Mixed Models Analysis|||||0.063|-0.015|0.216
70930501|NCT04631016|141359553|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.186|TWO_SIDED|80.0|0.57|1.11|||Regression, Cox|||||1.11|0.57|0.186
70930502|NCT04631016|141359574|SUPERIORITY||Least square mean difference|0.067||||0.044|TWO_SIDED|80.0|0.017|0.116||One-sided p-value|Mixed Models Analysis|Kenward-Roger correction has been used for degrees of freedom approximation in the generation of model.||Results are based on the mixed model for repeated measures (MMRM) analysis at Week 12.||0.116|0.017|0.044
70930503|NCT04631016|141359574|SUPERIORITY||Least square mean difference|0.07||||0.036|TWO_SIDED|80.0|0.02|0.12||One-sided p-value|Mixed Models Analysis|Kenward-Roger correction has been used for degrees of freedom approximation in the generation of model.||Results are based on the MMRM analysis at Week 28.||0.120|0.020|0.036
71050430|NCT04442490|141606994|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.58||0.0199|TWO_SIDED|95.0|-2.5|-0.2|||MMRM||Model used was MMRM with treatment (SAGE-217/placebo), baseline HAM-A total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Placebo, SAGE-217||-0.2|-2.5|0.0199
71050431|NCT04442490|141606996|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.5||0.3216|TWO_SIDED|95.0|-0.5|1.5|||MMRM||Model used is MMRM with treatment(SAGE-217/placebo), baseline SF-36v2 domain/component score, antidepressant use at baseline(Yes/No)assessment time point and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Physical Functioning Domain Score: Change from Baseline at Day 8||1.5|-0.5|0.3216
71050432|NCT04442490|141606996|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.53||0.1247|TWO_SIDED|95.0|-0.2|1.8|||MMRM||Model used is MMRM with treatment(SAGE-217/placebo), baseline SF-36v2 domain/component score, antidepressant use at baseline(Yes/No)assessment time point and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Physical Functioning Domain Score: Change from Baseline at Day 15||1.8|-0.2|0.1247
71050433|NCT04442490|141606996|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.56||0.1111|TWO_SIDED|95.0|-0.2|2.0|||MMRM||Model used is MMRM with treatment(SAGE-217/placebo), baseline SF-36v2 domain/component score, antidepressant use at baseline(Yes/No)assessment time point and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Physical Functioning Domain Score: Change from Baseline at Day 28||2.0|-0.2|0.1111
71050434|NCT04442490|141606996|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.59||0.1449|TWO_SIDED|95.0|-0.3|2.0|||MMRM||Model used is MMRM with treatment(SAGE-217/placebo), baseline SF-36v2 domain/component score, antidepressant use at baseline(Yes/No)assessment time point and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Physical Functioning Domain Score: Change from Baseline at Day 42||2.0|-0.3|0.1449
71050435|NCT04442490|141606996|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.59||0.8242|TWO_SIDED|95.0|-1.3|1.0|||MMRM||Model used is MMRM with treatment(SAGE-217/placebo), baseline SF-36v2 domain/component score, antidepressant use at baseline(Yes/No)assessment time point and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Role-Physical Domain Score: Change from Baseline at Day 8||1.0|-1.3|0.8242
71050436|NCT04442490|141606996|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.62||0.8329|TWO_SIDED|95.0|-1.4|1.1|||MMRM|||Role-Physical Domain Score: Change from Baseline at Day 15||1.1|-1.4|0.8329
71050437|NCT04442490|141606996|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.63||0.8127|TWO_SIDED|95.0|-1.4|1.1|||MMRM|||Role-Physical Domain Score: Change from Baseline at Day 28||1.1|-1.4|0.8127
71050438|NCT04442490|141606996|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.64||0.5435|TWO_SIDED|95.0|-0.9|1.6|||MMRM|||Role-Physical Domain Score: Change from Baseline at Day 42||1.6|-0.9|0.5435
71050439|NCT04442490|141606996|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.63||0.3551|TWO_SIDED|95.0|-0.7|1.8|||MMRM|||Bodily Pain Domain Score: Change from Baseline at Day 8||1.8|-0.7|0.3551
71050440|NCT04442490|141606996|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.68||0.7495|TWO_SIDED|95.0|-1.1|1.6|||MMRM|||Bodily Pain Domain Score: Change from Baseline at Day 15||1.6|-1.1|0.7495
71050441|NCT04442490|141606996|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.7||0.6471|TWO_SIDED|95.0|-1.1|1.7|||MMRM|||Bodily Pain Domain Score: Change from Baseline at Day 28||1.7|-1.1|0.6471
71050442|NCT04442490|141606996|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.75||0.1832|TWO_SIDED|95.0|-0.5|2.5|||MMRM|||Bodily Pain Domain Score: Change from Baseline at Day 42||2.5|-0.5|0.1832
71050443|NCT04442490|141606996|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.5||0.0168|TWO_SIDED|95.0|0.2|2.2|||MMRM|||General Health Domain Score: Change from Baseline at Day 8||2.2|0.2|0.0168
71050444|NCT04442490|141606996|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.54||0.0787|TWO_SIDED|95.0|-0.1|2.0|||MMRM|||General Health Domain Score: Change from Baseline at Day 15||2.0|-0.1|0.0787
71050445|NCT04442490|141606996|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.59||0.4273|TWO_SIDED|95.0|-0.7|1.6|||MMRM|||General Health Domain Score: Change from Baseline at Day 28||1.6|-0.7|0.4273
71050446|NCT04442490|141606996|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.62||0.0938|TWO_SIDED|95.0|-0.2|2.2|||MMRM|||General Health Domain Score: Change from Baseline at Day 42||2.2|-0.2|0.0938
71050447|NCT04442490|141606996|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|0.88||0.0033|TWO_SIDED|95.0|0.9|4.3|||MMRM|||Vitality Domain Score: Change from Baseline at Day 8||4.3|0.9|0.0033
70930504|NCT04496752|141359580|EQUIVALENCE|Weighted Cohen's kappa statistics were computed between DCTClock-pen and MMSE, and between DCTClock-tablet and MMSE. A TOST (two one-sided test) of equivalence was planned, with a difference in kappa of 0.2 specified a priori as significant.|Difference in Cohen's Kappa|0.07|||||TWO_SIDED|90.0|-0.05|0.19|||||The difference is Cohen's kappa is (tablet - pen). The confidence interval is estimated with a nonparametric bootstrap (5000 samples).|||0.19|-0.05|
70930505|NCT04967599|141359610|SUPERIORITY|||||||0.81|||||||Kruskal-Wallis|||||||.81
71050448|NCT04442490|141606996|SUPERIORITY||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|1.03||0.0029|TWO_SIDED|95.0|1.1|5.1|||MMRM|||Vitality Domain Score: Change from Baseline at Day 15||5.1|1.1|0.0029
71050449|NCT04442490|141606996|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|1.04||0.0791|TWO_SIDED|95.0|-0.2|3.9|||MMRM|||Vitality Domain Score: Change from Baseline at Day 28||3.9|-0.2|0.0791
71050450|NCT04442490|141606996|SUPERIORITY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.12||0.0761|TWO_SIDED|95.0|-0.2|4.2|||MMRM|||Vitality Domain Score: Change from Baseline at Day 42||4.2|-0.2|0.0761
71050451|NCT04442490|141606996|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.91||0.1568|TWO_SIDED|95.0|-0.5|3.1|||MMRM|||Social Functioning Domain Score: Change from Baseline at Day 8||3.1|-0.5|0.1568
71050452|NCT04442490|141606996|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.99||0.2807|TWO_SIDED|95.0|-0.9|3.0|||MMRM|||Social Functioning Domain Score: Change from Baseline at Day 15||3.0|-0.9|0.2807
71050453|NCT04442490|141606996|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.05||0.7751|TWO_SIDED|95.0|-1.8|2.4|||MMRM|||Social Functioning Domain Score: Change from Baseline at Day 28||2.4|-1.8|0.7751
71050454|NCT04442490|141606996|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|1.07||0.0913|TWO_SIDED|95.0|-0.3|3.9|||MMRM|||Social Functioning Domain Score: Change from Baseline at Day 42||3.9|-0.3|0.0913
71050455|NCT04442490|141606996|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.05||0.2863|TWO_SIDED|95.0|-0.9|3.2|||MMRM|||Role-Emotional Domain Score: Change from Baseline at Day 8||3.2|-0.9|0.2863
71050456|NCT04442490|141606996|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.13||0.1801|TWO_SIDED|95.0|-0.7|3.7|||MMRM|||Role-Emotional Domain Score: Change from Baseline at Day 15||3.7|-0.7|0.1801
71050457|NCT04442490|141606996|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|1.16||0.1107|TWO_SIDED|95.0|-0.4|4.1|||MMRM|||Role-Emotional Domain Score: Change from Baseline at Day 28||4.1|-0.4|0.1107
71050458|NCT04442490|141606996|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.23||0.3274|TWO_SIDED|95.0|-1.2|3.6|||MMRM|||Role-Emotional Domain Score: Change from Baseline at Day 42||3.6|-1.2|0.3274
71050459|NCT04442490|141606996|SUPERIORITY||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|0.93||0.0873|TWO_SIDED|95.0|-0.2|3.4|||MMRM|||Mental Health Domain Score: Change from Baseline at Day 8||3.4|-0.2|0.0873
71050460|NCT04442490|141606996|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|1.05||0.0871|TWO_SIDED|95.0|-0.3|3.9|||MMRM|||Mental Health Domain Score: Change from Baseline at Day 15||3.9|-0.3|0.0871
71050461|NCT04442490|141606996|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.12||0.3095|TWO_SIDED|95.0|-1.1|3.3|||MMRM|||Mental Health Domain Score: Change from Baseline at Day 28||3.3|-1.1|0.3095
71050462|NCT04442490|141606996|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|1.17||0.1477|TWO_SIDED|95.0|-0.6|4.0|||MMRM|||Mental Health Domain Score: Change from Baseline at Day 42||4.0|-0.6|0.1477
70850737|NCT04518995|141189578|SUPERIORITY||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|1.4|2.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2.4|1.4|<0.0001
70850738|NCT04518995|141189579|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|0.5|1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.3|0.5|<0.0001
71050463|NCT04442490|141606997|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.57||0.0828|TWO_SIDED|95.0|-2.1|0.1|||MMRM||Model used was the MMRM with treatment (SAGE-217/placebo), baseline PHQ-9 total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from Baseline at Day 8||0.1|-2.1|0.0828
71050464|NCT04442490|141606997|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.62||0.0606|TWO_SIDED|95.0|-2.4|0.1|||MMRM||Model used was the MMRM with treatment (SAGE-217/placebo), baseline PHQ-9 total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from Baseline at Day 15||0.1|-2.4|0.0606
71050465|NCT04442490|141606997|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.63||0.1079|TWO_SIDED|95.0|-2.3|0.2|||MMRM||Model used was the MMRM with treatment (SAGE-217/placebo), baseline PHQ-9 total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from Baseline at Day 28||0.2|-2.3|0.1079
71050466|NCT04442490|141606997|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.66||0.3951|TWO_SIDED|95.0|-1.9|0.7|||MMRM||Model used was the MMRM with treatment (SAGE-217/placebo), baseline PHQ-9 total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from Baseline at Day 42||0.7|-1.9|0.3951
71050467|NCT00505375|141607006|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014|||||||ANCOVA|||"The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the AUC mean and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis."||||0.0014
70850739|NCT04518995|141189579|SUPERIORITY||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|1.0|1.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.8|1.0|<0.0001
70850740|NCT04518995|141189579|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|1.0|2.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2.0|1.0|<0.0001
71050468|NCT03347422|141607007|SUPERIORITY||Odds Ratio (OR)|15.94|||<|0.001|TWO_SIDED|95.0|2.88|88.04||Threshold for significance was 0.05.|Cochran-Mantel-Haenszel||Stratified by baseline hemoglobin (\< median versus \>=median) and geographic region (Asia/Other, North America, and Europe).|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when primary outcome measure was statistically significant at two-sided 0.05 level.||88.04|2.88|<0.001
71050469|NCT03347422|141607009|SUPERIORITY||LS mean difference|2.56|STANDARD_ERROR_OF_MEAN|0.408|<|0.001|TWO_SIDED|95.0|1.75|3.38||Threshold of significance at 0.05 level.|Mixed model for repeated measures|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05 level.||3.38|1.75|<0.001
71105006|NCT02521285|141717055|SUPERIORITY|||||||0.645|||||||t-test, 2 sided|||||||0.645
71105007|NCT02521285|141717055|SUPERIORITY|||||||0.878|||||||t-test, 2 sided|||||||0.878
71105008|NCT02521285|141717063|SUPERIORITY|||||||0.755|||||||t-test, 2 sided|||||||0.755
71050470|NCT03347422|141607010|SUPERIORITY||LS mean difference|8.93|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|4.0|13.85||Threshold of significance at 0.05 level.|Mixed model for repeated measures|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05 level.||13.85|4.00|<0.001
71050471|NCT00910091|141607033|SUPERIORITY_OR_OTHER|||||||0.1895|TWO_SIDED||||||Kaplan-Meier Analysis|||||||0.1895
71050472|NCT00910091|141607034|SUPERIORITY_OR_OTHER|||||||0.0203|TWO_SIDED||||||Kaplan-Meier Analysis|||||||0.0203
71050473|NCT00910091|141607036|SUPERIORITY_OR_OTHER|||||||0.698|TWO_SIDED||||||Kaplan-Meier Analysis|||||||0.6980
71050474|NCT00910091|141607037|SUPERIORITY_OR_OTHER|||||||0.3078|TWO_SIDED||||||Kaplan-Meier Analysis|||||||0.3078
71050475|NCT00910091|141607038|SUPERIORITY_OR_OTHER|||||||0.0484|TWO_SIDED||||||Kaplan-Meier Analysis|||||||0.0484
71050476|NCT04870138|141607039|OTHER|||||||1||||||One-sided Fisher's Exact Test with alpha = 0.05|Fisher Exact|||||||1.000
71050477|NCT04870138|141607041|OTHER||||||<|0.0001|||||||t-test, 1 sided|One-sided single sample t-test with alpha=0.05||Null hypothesis: The proportion of the strain in the inoculum = 0.5||||<0.0001
71050478|NCT01155024|141607080|NON_INFERIORITY_OR_EQUIVALENCE|10 participants required to detect one value change in rating for the SCS scale, with 80% power.|||||>|0.4||95.0||||Two-Sided|t-test, 2 sided|||Alpha level of 0.05||||>0.4
71050479|NCT02633488|141607090|EQUIVALENCE|equivalence defined as less that 2 SD in FMD between 2 treatments|||||>|0.05||||||FMD % change exceeded the threshold of our statistical significance test, i.e. the null hypothesis that there was no effect of metformin remained tenable.|t-test, 2 sided|||||||>0.05
71050480|NCT03167723|141607095|NON_INFERIORITY|15% Non-Inferiority||||||0.036|||||||Farrington-Manning|||||||0.036
71050481|NCT01175811|141607106|SUPERIORITY_OR_OTHER||LSmean difference|0.01|||||TWO_SIDED|95.0|-0.14|0.16||||||||0.16|-0.14|
71050482|NCT01175811|141607107|SUPERIORITY_OR_OTHER||LSmean Difference|0.0|||||TWO_SIDED|95.0|-0.15|0.16||||||||0.16|-0.15|
71050483|NCT01175811|141607108|SUPERIORITY_OR_OTHER|||||||0.344||95.0||||P-value is for the comparison of participants achieving \<=6.5% HbA1c at 12 weeks. P-value was not adjusted for multiplicity and should be interpreted as nominal.|Fisher Exact|||||||0.344
71050484|NCT01175811|141607108|SUPERIORITY_OR_OTHER|||||||0.822||95.0||||P-value is for the comparison of participants achieving \<=7.0% HbA1c at 12 weeks. P-value was not adjusted for multiplicity and should be interpreted as nominal.|Fisher Exact|||||||0.822
71050485|NCT01175811|141607108|SUPERIORITY_OR_OTHER|||||||0.417||95.0||||P-value is for the comparison of participants achieving \<=6.5% HbA1c at 24 weeks. P-value was not adjusted for multiplicity and should be interpreted as nominal.|Fisher Exact|||||||0.417
71050486|NCT01175811|141607108|SUPERIORITY_OR_OTHER|||||||0.392||95.0||||P-value is for the comparison of participants achieving \<=7.0% HbA1c at 24 weeks. P-value was not adjusted for multiplicity and should be interpreted as nominal.|Fisher Exact|||||||0.392
71050487|NCT01340768|141607125|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.52||||0.028|TWO_SIDED|95.0|0.29|0.94||P-value for association between treatment groups and proportions controlling for prior therapy (monotherapy or combination therapy).|Cochran-Mantel-Haenszel|||||0.94|0.29|0.028
71050488|NCT01340768|141607126|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49||||0.006|TWO_SIDED|95.0|0.29|0.83||P-value for association between treatment groups and proportions controlling for prior therapy (monotherapy or combination therapy).|Cochran-Mantel-Haenszel|||||0.83|0.29|0.006
71050489|NCT02992418|141607168|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% confidence interval (CI) of the ratio of GMCs between groups (Group 1/ Group 2) was greater than (\>) 1/1.5 for each antigen. Overall non-inferiority was demonstrated if the 4 antigens achieved non-inferiority.|GMC ratio|0.848|||||TWO_SIDED|95.0|0.721|0.997||||||Anti-PT||0.997|0.721|
71050490|NCT02992418|141607168|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMCs between groups (Group 1/ Group 2) was \> 1/1.5 for each antigen. Overall non-inferiority was demonstrated if the 4 antigens achieved non-inferiority.|GMC ratio|1.02|||||TWO_SIDED|95.0|0.892|1.18||||||Anti-FHA||1.18|0.892|
71105009|NCT02521285|141717064|SUPERIORITY|||||||0.397|||||||t-test, 2 sided|||Difference between arms||||0.397
71050491|NCT02992418|141607168|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMCs between groups (Group 1/ Group 2) was \> 1/1.5 for each antigen. Overall non-inferiority was demonstrated if the 4 antigens achieved non-inferiority.|GMC ratio|1.11|||||TWO_SIDED|95.0|0.836|1.46||||||Anti-PRN||1.46|0.836|
71050492|NCT02992418|141607168|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMCs between groups (Group 1/ Group 2) was \> 1/1.5 for each antigen. Overall non-inferiority was demonstrated if the 4 antigens achieved non-inferiority.|GMC ratio|1.05|||||TWO_SIDED|95.0|0.827|1.33||||||Anti-FIM2+3||1.33|0.827|
71050493|NCT02992418|141607169|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the percentage difference was \> -10% for all antigens.|Percentage difference|0.26|||||TWO_SIDED|95.0|-4.53|5.04||||||Anti-D||5.04|-4.53|
71050494|NCT02992418|141607169|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the percentage difference was \> -10% for all antigens.|Percentage difference|-0.66|||||TWO_SIDED|95.0|-2.87|1.37||||||Anti-T||1.37|-2.87|
71050495|NCT02992418|141607170|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 1/Group 2) was \> 1/2 for each serotype. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|1.11|||||TWO_SIDED|95.0|0.862|1.44||||||Serotype 1||1.44|0.862|
71050496|NCT02992418|141607170|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 1/Group 2) was \> 1/2 for each serotype. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|1.19|||||TWO_SIDED|95.0|0.97|1.47||||||Serotype 2||1.47|0.97|
71050497|NCT02992418|141607170|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 1/Group 2) was \> 1/2 for each serotype. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.925|||||TWO_SIDED|95.0|0.739|1.16||||||Serotype 3||1.16|0.739|
71105010|NCT02521285|141717064|SUPERIORITY|||||||0.983|||||||t-test, 2 sided|||Difference in arms.||||0.983
71105011|NCT02521285|141717065|SUPERIORITY|||||||0.065|||||||t-test, 2 sided|||||||0.065
71105012|NCT02521285|141717065|SUPERIORITY|||||||0.203|||||||t-test, 2 sided|||||||0.203
71105013|NCT02521285|141717066|SUPERIORITY|||||||0.755|||||||t-test, 2 sided|||||||0.755
70850741|NCT04518995|141189579|SUPERIORITY||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|1.4|2.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2.4|1.4|<0.0001
71016807|NCT03692078|141541618|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-0.55|||<|0.0001|TWO_SIDED|95.0|-0.75|-0.35|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||-0.350|-0.750|<.0001
71016808|NCT03692078|141541618|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-0.85|||<|0.0001|TWO_SIDED|95.0|-1.051|-0.65|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||-0.650|-1.051|<.0001
71016809|NCT03692078|141541618|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.276||||0.1608|TWO_SIDED|95.0|-0.609|0.057|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||0.057|-0.609|0.1608
71016810|NCT03692078|141541618|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.278||||0.1575|TWO_SIDED|95.0|-0.613|0.056|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||0.056|-0.613|0.1575
71016811|NCT03692078|141541618|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.108||||0.9728|TWO_SIDED|95.0|-0.442|0.226|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.226|-0.442|0.9728
71016812|NCT03692078|141541618|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.127||||0.9262|TWO_SIDED|95.0|-0.461|0.208|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.208|-0.461|0.9262
71016813|NCT03692078|141541618|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.584|||<|0.0001|TWO_SIDED|95.0|-1.963|-1.204|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.204|-1.963|<.0001
71016814|NCT03692078|141541618|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.701|||<|0.0001|TWO_SIDED|95.0|-2.081|-1.32|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.320|-2.081|<.0001
71105014|NCT02521285|141717066|SUPERIORITY|||||||0.343|||||||t-test, 2 sided|||||||0.343
71105015|NCT02521285|141717067|SUPERIORITY|||||||0.281|||||||t-test, 2 sided|||||||0.281
71105016|NCT02521285|141717067|SUPERIORITY|||||||0.189|||||||t-test, 2 sided|||||||0.189
71105017|NCT02521285|141717068|SUPERIORITY|||||||0.083|||||||t-test, 2 sided|||||||0.083
71105018|NCT02521285|141717068|SUPERIORITY|||||||0.195|||||||t-test, 2 sided|||||||0.195
71105019|NCT02521285|141717069|SUPERIORITY|||||||0.755|||||||t-test, 2 sided|||||||0.755
71105020|NCT02521285|141717069|SUPERIORITY|||||||0.432|||||||t-test, 2 sided|||||||0.432
71105021|NCT02521285|141717070|SUPERIORITY|||||||0.463|||||||t-test, 2 sided|||||||0.463
70930506|NCT04967599|141359611|SUPERIORITY|||||||0.46|||||||Kruskal-Wallis|||||||.46
71050498|NCT02992418|141607170|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 1/Group 2) was \> 1/2 for each serotype. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.802|||||TWO_SIDED|95.0|0.644|0.999||||||Serotype 4||0.999|0.644|
71050499|NCT01992523|141607202|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||t-test, 2 sided|||Continuous data were expressed as mean ± standard deviation or medians (quartiles) as appropriate, and categorical data as proportions (%). Data were compared by means of the chi-2 test or Fisher exact test for categorical variables and unpaired t test or Mann-Whitney U-test for continuous variables, as appropriate. A P value \< .05 was considered statistically significant. All tests were two-sided.||||0.006
70930507|NCT04967599|141359612|SUPERIORITY|||||||0.49|||||||Kruskal-Wallis|||||||.49
71016815|NCT03692078|141541618|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.863|||<|0.0001|TWO_SIDED|95.0|-1.237|-0.489|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.489|-1.237|<.0001
71105022|NCT02521285|141717070|SUPERIORITY|||||||0.189|||||||t-test, 2 sided|||||||0.189
70930508|NCT04967599|141359613|SUPERIORITY|||||||0.59|||||||Kruskal-Wallis|||||||.59
71016816|NCT03692078|141541618|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.936|||<|0.0001|TWO_SIDED|95.0|-1.312|-0.56|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.560|-1.312|<.0001
71016817|NCT03692078|141541620|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.47|||<|0.0001|TWO_SIDED|95.0|3.31|3.63|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||3.630|3.310|<.0001
71016818|NCT03692078|141541620|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.508|||<|0.0001|TWO_SIDED|95.0|3.348|3.668|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||3.668|3.348|<.0001
71077882|NCT02913105|141664398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.9244|TWO_SIDED|90.0|0.96|1.04|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 7||1.04|0.96|0.9244
71077883|NCT02913105|141664398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.236|TWO_SIDED|90.0|0.99|1.08|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 14||1.08|0.99|0.2360
71077884|NCT02913105|141664398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.01||||0.699|TWO_SIDED|90.0|0.96|1.07|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 28||1.07|0.96|0.6990
71105023|NCT02521285|141717071|SUPERIORITY|||||||0.105|||||||t-test, 2 sided|||||||0.105
71105024|NCT02521285|141717071|SUPERIORITY|||||||0.161|||||||t-test, 2 sided|||||||0.161
71105025|NCT02521285|141717074|SUPERIORITY|||||||0.518|||||||t-test, 2 sided|||||||0.518
71105026|NCT02521285|141717075|SUPERIORITY|||||||0.876|||||||t-test, 2 sided|||||||0.876
70930509|NCT04967599|141359614|SUPERIORITY|||||||0.29|||||||Fisher Exact|||||||.29
70930510|NCT04967599|141359615|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||.49
70930511|NCT03662022|141359629|SUPERIORITY||incidence rate ratio|0.95|||<|0.017|TWO_SIDED|98.3|0.4|2.23||The significance level was determined at 0.017, to account for the fact that we made three comparisons, thus conclusions can be drawn by examining if the 98.3% CI for the incidence rate ratio (IRR) contains the critical value of 1.|Mixed Models Analysis|||||2.23|0.40|<0.017
70930512|NCT03662022|141359629|SUPERIORITY||incidence rate ratio|0.8||||0.017|TWO_SIDED|98.3|0.34|1.87|||Mixed Models Analysis|||||1.87|0.34|0.017
70930513|NCT03662022|141359629|SUPERIORITY||incidence rate ratio|0.58|||<|0.017|TWO_SIDED|98.3|0.22|1.56|||Mixed Models Analysis|||||1.56|0.22|<0.017
71016819|NCT03692078|141541620|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.891|||<|0.0001|TWO_SIDED|95.0|2.741|3.042|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||3.042|2.741|<.0001
70850742|NCT04518995|141189580|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.0|-0.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-0.5|-1.0|< 0.0001
70850743|NCT04518995|141189580|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-0.8|-1.3|< 0.0001
71016820|NCT03692078|141541620|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.873|||<|0.0001|TWO_SIDED|95.0|2.719|3.027|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||3.027|2.719|<.0001
71016821|NCT03692078|141541620|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.928|||<|0.0001|TWO_SIDED|95.0|2.775|3.082|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||3.082|2.775|<.0001
71016822|NCT03692078|141541620|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.896|||<|0.0001|TWO_SIDED|95.0|2.742|3.049|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||3.049|2.742|<.0001
71016823|NCT03692078|141541620|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.864|||<|0.0001|TWO_SIDED|95.0|0.672|1.055|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||1.055|0.672|<.0001
71050500|NCT02731326|141607232|EQUIVALENCE|The study was designed to have 80% power to detect a hazard ratio of 2 for recurrence detection (α = .05).|Hazard Ratio (HR)|1.56||||0.05|TWO_SIDED|95.0|1.06|2.3|||Regression, Cox||Treatment arm equals numerator. Control arm=denominator.|The study was designed to have 80% power to detect a hazard ratio of 2 for recurrence detection (α = .05). Kaplan-Meier curves were created for recurrence detection in the intervention and control groups over the 6-month follow-up period. Differences in time to recurrence between groups were assessed using a Cox proportional hazards model. Baseline variables that differed significantly between groups were included as covariates and adjusted Kaplan-Meier curves were constructed.||2.30|1.06|0.05
71050501|NCT02731326|141607233|EQUIVALENCE|The study was designed to have 80% power to detect a hazard ratio of 2 (α = .05).|Hazard Ratio (HR)|0.33||||0.05|TWO_SIDED|95.0|0.09|0.58|||Regression, Cox||Treatment arm equals numerator. Control arm=denominator.|Kaplan-Meier curves were created for assessing time to treatment for intervention and control groups. Time to treatment was defined as the time interval from detection of a recurrent arrhythmia to treatment for that arrhythmia.||0.58|0.09|0.05
71105027|NCT02521285|141717075|SUPERIORITY|||||||0.505|||||||t-test, 2 sided|||||||0.505
71105028|NCT02521285|141717076|SUPERIORITY|||||||0.463|||||||t-test, 2 sided|||||||0.463
71105029|NCT02521285|141717076|SUPERIORITY|||||||0.094|||||||t-test, 2 sided|||||||0.094
71105030|NCT02521285|141717077|SUPERIORITY|||||||0.105|||||||t-test, 2 sided|||||||0.105
71105031|NCT02521285|141717077|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||0.13
71105032|NCT04537650|141717097|SUPERIORITY||Odds Ratio (OR)|21.0|||<|0.001|TWO_SIDED|95.0|1.8|243.24|||Chi-squared|||||243.24|1.8|<0.001
71105033|NCT04537650|141717098|SUPERIORITY||Odds Ratio (OR)|45.0|||<|0.001|TWO_SIDED|95.0|4.15|487.5|||Chi-squared|||||487.5|4.15|<0.001
71105034|NCT00879398|141717115|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|t-test, 2 sided|||||||<0.0001
71105035|NCT00879398|141717116|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|t-test, 2 sided|||||||<0.0001
71105036|NCT00879398|141717117|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|t-test, 2 sided|||||||<0.0001
71105037|NCT00879398|141717119|SUPERIORITY_OR_OTHER|||||||0.1319||95.0||||Statistical significant level: 0.05|Chi-squared|||Geriatric Status: \<65 years versus (vs) Geriatric Status: ≥65 years||||0.1319
70850744|NCT04518995|141189580|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-0.8|-1.2|< 0.0001
71050502|NCT02731326|141607234|SUPERIORITY||Hazard Ratio (HR)|0.33|||<|0.0001|TWO_SIDED|95.0|0.19|0.58|||Regression, Cox|||||0.58|0.19|<.0001
71050503|NCT02731326|141607235|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
71050504|NCT02731326|141607236|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||||||0.89
71016824|NCT03692078|141541620|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.786|||<|0.0001|TWO_SIDED|95.0|0.592|0.981|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||0.981|0.592|<.0001
71050505|NCT00302081|141607242|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority for SVR was concluded if the lower limit of the one-sided 95% CI was greater than -10%. Otherwise, noninferiority was concluded for both dose and treatment duration comparisons if the lower limits of the two-sided 95% CIs were greater than -10%.|Risk Difference (RD)|-0.02||||0.041||95.0|-0.1|1.0||The Hochberg procedure was used to adjust for the multiple comparisons (\[PEG2b 1.0/R(24 weeks)\] - \[PEG2b 1.5/R(24 weeks\]) and (\[PEG2b 1.5/R(16 weeks)\]-\[PEG2b 1.5/R(24 weeks)\]).|z-test (non-inferiority margin=-0.1)|SVR rates are 0.665 (153/230 subjects) in the 1.5-dose group and 0.643 (144/224 subjects) in the 1.0-dose group, for a risk difference of -0.02.||This is an evaluation of the effect of the peginterferon alfa-2b dose (1.0 vs 1.5 micrograms/kg/week) on the primary outcome measure.||1|-0.10|0.041
71050506|NCT00302081|141607242|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority for SVR was concluded if the lower limit of the one-sided 95% CI was greater than -10%. Otherwise, noninferiority was concluded for both dose and treatment duration comparisons if the lower limits of the two-sided 95% CIs were greater than -10%.|Risk Difference (RD)|-0.1||||0.495||95.0|-0.17|1.0||The Hochberg procedure was used to adjust for the multiple comparisons (\[PEG2b 1.0/R(24 weeks)\] - \[PEG2b 1.5/R(24 weeks\]) and (\[PEG2b 1.5/R(16 weeks\]-\[PEG2b 1.5/R(24 weeks\]).|z-test (non-inferiority margin=-0.1)|SVR rates are 0.665 (153/230 subjects) in the 24-week group and 0.566 (129/228 subjects) in the 16-week group, for a risk difference of -0.10.||This is an evaluation of the effect of treatment duration (24 weeks vs 16 weeks) on the primary outcome measure.||1|-0.17|0.495
71050507|NCT02500641|141607250|SUPERIORITY|||||||0.5298|||||||ANCOVA|||||||0.5298
71050508|NCT00643565|141607264|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.7189|TWO_SIDED|95.0|0.61|1.41|||Log Rank|||The HR was calculated based on a stratified Cox proportional hazards model, with stratification factors of age and histology/disease risk.||1.41|0.61|0.7189
71050509|NCT00643565|141607265|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.3211|TWO_SIDED|95.0|0.51|1.25|||Log Rank|||The HR was calculated based on a stratified Cox proportional hazards model, with stratification factors of age and histology/disease risk.||1.25|0.51|0.3211
71050510|NCT01355159|141607276|SUPERIORITY||Risk Ratio (RR)|1.1||||0.37|TWO_SIDED|95.0|0.9|1.34|||Chi-squared|||||1.34|0.90|0.37
71016825|NCT03692078|141541620|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.641|||<|0.0001|TWO_SIDED|95.0|0.452|0.829|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||0.829|0.452|<.0001
71016826|NCT03692078|141541620|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.485|||<|0.0001|TWO_SIDED|95.0|0.29|0.68|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||0.680|0.290|<.0001
71050511|NCT01355159|141607278|SUPERIORITY||Risk Ratio (RR)|1.29||||0.37|TWO_SIDED|95.0|0.74|2.28|||Chi-squared|||||2.28|0.74|0.37
71050512|NCT01355159|141607279|SUPERIORITY||Risk Ratio (RR)|0.64||||0.21|TWO_SIDED|95.0|0.31|1.31|||Chi-squared|||||1.31|0.31|0.21
71050513|NCT01355159|141607280|SUPERIORITY||Risk Ratio (RR)|0.97||||0.71|TWO_SIDED|95.0|0.82|1.15|||Chi-squared|||||1.15|0.82|0.71
71050514|NCT01355159|141607281|SUPERIORITY||Risk Ratio (RR)|0.99||||0.87|TWO_SIDED|95.0|0.86|1.13|||Chi-squared|||||1.13|0.86|0.87
71050515|NCT01355159|141607282|SUPERIORITY||Risk Ratio (RR)|1.21||||0.75|TWO_SIDED|95.0|0.37|3.96|||Chi-squared|||||3.96|0.37|0.75
71050516|NCT01355159|141607283|SUPERIORITY||Risk Ratio (RR)|1.52||||0.19|TWO_SIDED|95.0|0.81|2.84|||Chi-squared|||||2.84|0.81|0.19
71050517|NCT01355159|141607284|SUPERIORITY||Mean Difference (Final Values)|0.34|STANDARD_DEVIATION|7.0||0.61|TWO_SIDED|95.0|-0.96|1.63|||t-test, 2 sided|||||1.63|-0.96|0.61
71050518|NCT01355159|141607285|SUPERIORITY||Risk Ratio (RR)|0.6||||0.14|TWO_SIDED|95.0|0.3|1.19|||Chi-squared|||||1.19|0.30|0.14
71050519|NCT01355159|141607286|SUPERIORITY||Risk Ratio (RR)|0.76||||0.37|TWO_SIDED|95.0|0.41|1.39|||Chi-squared|||||1.39|0.41|0.37
71050520|NCT01355159|141607287|SUPERIORITY||Risk Ratio (RR)|1.03||||0.82|TWO_SIDED|95.0|0.81|1.3|||Chi-squared|||||1.30|0.81|0.82
71050521|NCT01355159|141607288|SUPERIORITY||Risk Ratio (RR)|0.87||||0.79|TWO_SIDED|95.0|0.31|2.44|||Chi-squared|||||2.44|0.31|0.79
71050522|NCT01355159|141607289|SUPERIORITY||Risk Ratio (RR)|0.63||||0.07|TWO_SIDED|95.0|0.37|1.05|||Chi-squared|||||1.05|0.37|0.07
71050523|NCT01355159|141607290|SUPERIORITY||Risk Ratio (RR)|1.2||||0.65|TWO_SIDED|95.0|0.54|2.66|||Chi-squared|||||2.66|0.54|0.65
71050524|NCT01355159|141607291|SUPERIORITY||Risk Ratio (RR)|0.34||||0.1|TWO_SIDED|95.0|0.09|1.23|||Chi-squared|||||1.23|0.09|0.10
71050525|NCT01355159|141607292|SUPERIORITY||Risk Ratio (RR)|2.04||||0.33|TWO_SIDED|95.0|0.49|8.57|||Chi-squared|||||8.57|0.49|0.33
71050526|NCT01355159|141607293|SUPERIORITY||Risk Ratio (RR)|0.97||||0.94|TWO_SIDED|95.0|0.47|2.0|||Chi-squared|||||2.00|0.47|0.94
70930514|NCT04490109|141359632|SUPERIORITY|The ANCOVA model for primary endpoint change from Baseline to Week 4 in average WI-NRS will have treatment group and Baseline weekly average WI-NRS as explanatory variables. Hypothesis will be tested using a Dunnett Testing Method, applying pairwise comparisons of each group to vehicle using a one-sided familywise error rate of 0.10. Treatment effect will be estimated as least squares means using vehicle as reference and adjusted using Dunnett Testing Method and presented with one-sided 90% CI.||||||0.0148|||||||ANCOVA|||Approximately 576 subjects may be enrolled to account for 16.7% drop out rate prior to completing the study. A total of 160 evaluable subjects per group are required to achieve at least 80% power to detect a difference of 0.65 in mean WI-NRS change from Baseline to Week 4 between one of two active doses of B244 and vehicle control when assuming a standard deviation of 2.5 and applying a Dunnett Testing Method at a one-sided familywise error rate of 0.10.||||0.0148
70941548|NCT02229396|141383844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.08|STANDARD_ERROR_OF_MEAN|4.007|<|0.001|TWO_SIDED|95.0|-27.95|-12.2|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-12.20|-27.95|<0.001
71016827|NCT03692078|141541620|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.747|||<|0.0001|TWO_SIDED|95.0|0.562|0.932|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||0.932|0.562|<.0001
71016828|NCT03692078|141541620|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.833|||<|0.0001|TWO_SIDED|95.0|0.645|1.021|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||1.021|0.645|<.0001
71105038|NCT00879398|141717119|SUPERIORITY_OR_OTHER|||||||0.601||95.0||||Statistical significant level: 0.05|Chi-squared|||Comparison among Age Categories: \<50 years, 50 to 59 years, 60 to 69 years, 70 to 79 years, and ≥80 years.||||0.6010
70941549|NCT02229396|141383844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.64|STANDARD_ERROR_OF_MEAN|3.947|<|0.001|TWO_SIDED|95.0|-24.39|-8.89|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-8.89|-24.39|<0.001
71016829|NCT03692078|141541620|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.579|||<|0.0001|TWO_SIDED|95.0|-0.889|-0.268|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.268|-0.889|<.0001
71016830|NCT03692078|141541620|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.635|||<|0.0001|TWO_SIDED|95.0|-0.949|-0.321|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.321|-0.949|<.0001
71016831|NCT03692078|141541620|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.542|||<|0.0001|TWO_SIDED|95.0|-0.853|-0.231|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.231|-0.853|<.0001
71016832|NCT03692078|141541620|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.613|||<|0.0001|TWO_SIDED|95.0|-0.924|-0.301|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.301|-0.924|<.0001
71105039|NCT00879398|141717119|SUPERIORITY_OR_OTHER|||||||0.0289||95.0||||Statistical significant level: 0.05|Chi-squared|||Male vs Female||||0.0289
71105040|NCT00879398|141717119|SUPERIORITY_OR_OTHER|||||||0.3078||95.0||||Statistical significant level: 0.05|Chi-squared|||Comparison among Weight Categories: \<50 kg, 50 to 60 kg, 60 to 70 kg, and ≥70 kg.||||0.3078
71105041|NCT00879398|141717119|SUPERIORITY_OR_OTHER|||||||0.9614||95.0||||Statistical significant level: 0.05|Chi-squared|||Comparison among Height Categories: \<160 cm, 160 to 170 cm, and ≥170 cm.||||0.9614
71105042|NCT00879398|141717119|SUPERIORITY_OR_OTHER|||||||0.0788||95.0||||Statistical significant level: 0.05|Fisher Exact|||Allergic History: Yes vs Allergic History: No||||0.0788
70850745|NCT04518995|141189580|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-1.1|-1.6|< 0.0001
70850746|NCT04518995|141189580|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-0.8|-1.3|< 0.0001
71050527|NCT01355159|141607294|SUPERIORITY||Risk Ratio (RR)|1.61||||0.06|TWO_SIDED|95.0|0.97|2.66|||Chi-squared|||||2.66|0.97|0.06
71050528|NCT01355159|141607295|SUPERIORITY||Risk Ratio (RR)|2.37||||0.21|TWO_SIDED|95.0|0.61|9.14|||Chi-squared|||||9.14|0.61|0.21
71050529|NCT01355159|141607296|SUPERIORITY||Risk Ratio (RR)|1.2||||0.38|TWO_SIDED|95.0|0.8|1.8|||Chi-squared|||||1.80|0.80|0.38
71050530|NCT01355159|141607297|SUPERIORITY||Mean Difference (Net)|-1.6||||46|TWO_SIDED|95.0|-5.84|2.64|||t-test, 2 sided|||||2.64|-5.84|046
71050531|NCT01355159|141607298|SUPERIORITY||Risk Ratio (RR)|0.87||||0.79|TWO_SIDED|95.0|0.31|2.44|||Chi-squared|||||2.44|0.31|0.79
71050532|NCT01355159|141607299|SUPERIORITY||Risk Ratio (RR)|2.0||||0.42|TWO_SIDED|95.0|0.37|10.92|||Chi-squared|||||10.92|0.37|0.42
71050533|NCT04700280|141607301|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|2.69||0.617|TWO_SIDED|90.0|-6.2|3.4|||Mixed Models Analysis|||||3.4|-6.2|0.617
71050534|NCT04700280|141607303|SUPERIORITY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.62||0.3089|TWO_SIDED|90.0|-1.7|0.41|||Mixed Models Analysis|||Week 4||0.41|-1.70|0.3089
71050535|NCT04700280|141607303|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.71||0.2834|TWO_SIDED|90.0|-1.97|0.43|||Mixed Models Analysis|||Week 8||0.43|-1.97|0.2834
71050536|NCT04700280|141607303|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.95||0.7109|TWO_SIDED|90.0|-2.02|1.3|||Mixed Models Analysis|||Week 12||1.30|-2.02|0.7109
71050537|NCT04700280|141607304|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.81||0.859|TWO_SIDED|90.0|-3.6|2.9|||Mixed Models Analysis|||Week 4||2.9|-3.6|0.859
71050538|NCT04700280|141607304|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|2.46||0.837|TWO_SIDED|90.0|-3.8|4.8|||Mixed Models Analysis|||Week 8||4.8|-3.8|0.837
71050539|NCT00741936|141607317|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|||||||<0.05
71050540|NCT00741936|141607318|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|T-Tests were implemented: 1) between two groups of each time frame; 2) between each treatment group of each time frame and its baseline.||||||<0.05
71050541|NCT00741936|141607319|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|T-Tests were implemented: 1) between two groups of each time frame; 2) between each treatment group of each time frame and its baseline||||||<0.05
71050542|NCT00741936|141607320|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|T-Tests were implemented: 1) between two groups of each time frame; 2) between each treatment group of each time frame and its baseline.||||||<0.05
71050543|NCT00741936|141607321|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|Chi-squared test from Crosstabs analysis was implemented between two treatment groups in each time frame.||||||<0.05
71050544|NCT00741936|141607322|SUPERIORITY_OR_OTHER|||||||0||95.0|||||simple percentage|||||||0
71050545|NCT00741936|141607323|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|||||||<0.05
71050546|NCT00741936|141607324|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-samples t-test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
71050547|NCT00741936|141607325|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
71050548|NCT00741936|141607326|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
71050549|NCT00741936|141607327|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
71050550|NCT02450526|141607328|SUPERIORITY|The model includes treatment group, stratification factors, gender and baseline severity score of glabellar lines at maximum frown measured by the ILA, and centre as explanatory variables and responder (Yes or No) as response variable.|Treatment difference|94.3|||<|0.0001|TWO_SIDED|95.0|90.8|97.7||The test is two-sided at the significance level of 0.025.|Regression, Logistic|||Superiority analysis of Dysport® to placebo was tested using a multivariate logistic regression model.||97.7|90.8|<0.0001
71050551|NCT02450526|141607329|SUPERIORITY|The model includes treatment group, stratification factors, gender and baseline severity score of glabellar lines at maximum frown measured by the ILA, and centre as explanatory variables and responder (Yes or No) as response variable.|Treatment difference|87.5|||<|0.0001|TWO_SIDED|95.0|82.5|92.4||The test is two-sided at the significance level of 0.025.|Regression, Logistic|||Superiority analysis of Dysport® to placebo was tested using a multivariate logistic regression model.||92.4|82.5|<0.0001
71050552|NCT02450526|141607330|NON_INFERIORITY|The model includes treatment group, stratification factors, gender and baseline severity score of glabellar lines at maximum frown measured by the ILA, and centre as explanatory variables and responder (Yes or No) as response variable.|Treatment Difference|-2.4|||||TWO_SIDED|95.0|-6.7|1.9||||||The non-inferiority of Dysport® to Botox on the ILA at maximum frown was tested using a multivariate logistic regression model||1.9|-6.7|
71050553|NCT02450526|141607331|SUPERIORITY|The model includes treatment group, stratification factors, gender and baseline severity score of glabellar lines at maximum frown measured by the ILA and centre as explanatory variables and responder (Yes or No) as response variable.|Treatment difference|73.8|||<|0.0001|TWO_SIDED|95.0|59.1|88.4|||Regression, Logistic|||Superiority analysis of Dysport® to placebo was tested using a multivariate logistic regression model.||88.4|59.1|<0.0001
71050554|NCT02450526|141607332|SUPERIORITY|The comparison between mean scores of SGA at Treatment Cycle 1, Day 29 is based on 2 separate linear mixed models, adjusting on the two stratification parameters, gender and baseline ILA severity score, and the centre.|Treatment Difference|2.603|||<|0.0001|TWO_SIDED|95.0|2.327|2.878||The test was two-sided at the significance level of 0.05|Mixed Models Analysis|||Superiority analysis of Dysport® to placebo was tested using a linear mixed model.||2.878|2.327|<0.0001
71050555|NCT02450526|141607333|SUPERIORITY|The model includes treatment group, stratification factors, gender and baseline severity score of glabellar lines at maximum frown measured by the ILA, and centre as explanatory variables and responder (Yes or No) as response variable.|Treatment difference|83.7|||<|0.0001|TWO_SIDED|95.0|78.7|88.7|||Regression, Logistic|||Superiority analysis of Dysport® to placebo was tested using a multivariate logistic regression model.||88.7|78.7|<0.0001
71050556|NCT01150890|141607430|SUPERIORITY|||||||0.1941|||||||Overall Trend test|||The primary null hypothesis was tested sequentially using a linear trend test at the significance level of 0.05 (two-sided) using logistic regression modeling.||||0.1941
70930515|NCT04490109|141359632|SUPERIORITY|The ANCOVA model for primary endpoint change from Baseline to Week 4 in average WI-NRS will have treatment group and Baseline weekly average WI-NRS as explanatory variables. Hypothesis will be tested using a Dunnett Testing Method, applying pairwise comparisons of each group to vehicle using a one-sided familywise error rate of 0.10. Treatment effect will be estimated as least squares means using vehicle as reference and adjusted using Dunnett Testing Method and presented with one-sided 90% CI.||||||0.0143|||||||ANCOVA|||Approximately 576 subjects may be enrolled to account for 16.7% drop out rate prior to completing the study. A total of 160 evaluable subjects per group are required to achieve at least 80% power to detect a difference of 0.65 in mean WI-NRS change from Baseline to Week 4 between one of two active doses of B244 and vehicle control when assuming a standard deviation of 2.5 and applying a Dunnett Testing Method at a one-sided familywise error rate of 0.10.||||0.0143
70930516|NCT04490109|141359634|SUPERIORITY|||||||0.0205|||||||Regression, Logistic|||The frequency and rate of WI-NRS and AI-NRS responders will be reported and compared between treatment groups using a logistic regression model. Generalized estimating equations to account for repeated measures and within-subject variability may also be applied.||||0.0205
70930517|NCT04490109|141359635|SUPERIORITY|||||||0.0044|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0044
71016833|NCT03692078|141541620|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.606|||<|0.0001|TWO_SIDED|95.0|-2.959|-2.253|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.253|-2.959|<.0001
71016834|NCT03692078|141541620|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-2.722|||<|0.0001|TWO_SIDED|95.0|-3.078|-2.366|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.366|-3.078|<.0001
71016835|NCT03692078|141541620|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.829|||<|0.0001|TWO_SIDED|95.0|-3.177|-2.481|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.481|-3.177|<.0001
71016836|NCT03692078|141541620|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-3.024|||<|0.0001|TWO_SIDED|95.0|-3.378|-2.669|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.669|-3.378|<.0001
71016837|NCT03692078|141541620|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.144|||<|0.0001|TWO_SIDED|95.0|1.811|2.478|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||2.478|1.811|<.0001
71016838|NCT03692078|141541620|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.04|||<|0.0001|TWO_SIDED|95.0|1.701|2.379|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||2.379|1.701|<.0001
71050557|NCT01150890|141607430|SUPERIORITY||Difference in Response Rate|0.0||||1|TWO_SIDED|95.0|-0.09|0.09|||Chi-squared|||||0.09|-0.09|1.0000
71050558|NCT01150890|141607430|SUPERIORITY||Difference in Response Rate|0.1203||||0.0966|TWO_SIDED|95.0|-0.02|0.26|||Chi-squared|||||0.26|-0.02|0.0966
71050559|NCT01150890|141607430|SUPERIORITY||Difference in Response Rate|0.0597||||0.3208|TWO_SIDED|95.0|-0.06|0.17|||Chi-squared|||||0.17|-0.06|0.3208
70930518|NCT04490109|141359635|SUPERIORITY|||||||0.0077|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0077
70930519|NCT04490109|141359636|SUPERIORITY|||||||0.04|||||||Regression, Logistic|||The frequency and rate of WI-NRS and AI-NRS responders will be reported and compared between treatment groups using a logistic regression model. Generalized estimating equations to account for repeated measures and within-subject variability may also be applied.||||0.0400
70850747|NCT04518995|141189580|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.7|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-1.2|-1.7|< 0.0001
70930520|NCT04490109|141359636|SUPERIORITY|||||||0.0486|||||||Regression, Logistic|||The frequency and rate of WI-NRS and AI-NRS responders will be reported and compared between treatment groups using a logistic regression model. Generalized estimating equations to account for repeated measures and within-subject variability may also be applied.||||0.0486
70850748|NCT04518995|141189580|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-1.0|-1.5|< 0.0001
70850749|NCT04518995|141189580|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.8|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-1.3|-1.8|< 0.0001
70850750|NCT04518995|141189581|SUPERIORITY||Risk Difference (RD)|0.25|STANDARD_ERROR_OF_MEAN|0.044|<|0.0001|TWO_SIDED|95.0|0.17|0.34||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.34|0.17|< 0.0001
70930521|NCT04490109|141359638|SUPERIORITY|||||||0.0246|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0246
70930522|NCT04490109|141359638|SUPERIORITY|||||||0.0366|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0366
70930523|NCT04490109|141359639|SUPERIORITY|||||||0.0467|||||||Regression, Logistic|||The frequency and rate of WI-NRS and AI-NRS responders will be reported and compared between treatment groups using a logistic regression model. Generalized estimating equations to account for repeated measures and within-subject variability may also be applied.||||0.0467
70930524|NCT04490109|141359640|SUPERIORITY|||||||0.0293|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0293
70930525|NCT04490109|141359641|SUPERIORITY|||||||0.0045|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0045
70930526|NCT04490109|141359641|SUPERIORITY|||||||0.0043|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0043
70930527|NCT04490109|141359642|SUPERIORITY|||||||0.0026|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0026
70930528|NCT04490109|141359642|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0005
70930529|NCT04490109|141359643|SUPERIORITY|||||||0.0348|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0348
70930530|NCT04490109|141359643|SUPERIORITY|||||||0.0173|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0173
71016839|NCT03692078|141541620|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.181|||<|0.0001|TWO_SIDED|95.0|1.846|2.516|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||2.516|1.846|<.0001
71016840|NCT03692078|141541620|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.063|||<|0.0001|TWO_SIDED|95.0|1.725|2.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||2.400|1.725|<.0001
71016841|NCT03692078|141541620|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.117||||0.9705|TWO_SIDED|95.0|-0.256|0.49|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.490|-0.256|0.9705
71016842|NCT03692078|141541620|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.047||||1|TWO_SIDED|95.0|-0.425|0.332|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.332|-0.425|1.0000
71050560|NCT01150890|141607431|SUPERIORITY||Difference in Response Rate|0.0363||||0.6831|TWO_SIDED|95.0|-0.14|0.21|||Chi-squared|||||0.21|-0.14|0.6831
71050561|NCT01150890|141607431|SUPERIORITY||Difference in Response Rate|0.1477||||0.1396|TWO_SIDED|95.0|-0.04|0.34|||Chi-squared|||||0.34|-0.04|0.1396
71050562|NCT01150890|141607431|SUPERIORITY||Difference in Response Rate|0.0265||||0.7588|TWO_SIDED|95.0|-0.14|0.19|||Chi-squared|||||0.19|-0.14|0.7588
70930531|NCT04490109|141359644|SUPERIORITY|||||||0.0228|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0228
71050563|NCT01150890|141607432|SUPERIORITY|||||||0.4161|||||||ANCOVA|Analysis of covariance (ANCOVA) model adjusted for baseline CDAI score.||||||0.4161
71050564|NCT01150890|141607432|SUPERIORITY|||||||0.8094|||||||ANCOVA|ANCOVA model adjusted for baseline CDAI score.||||||0.8094
70930532|NCT04490109|141359644|SUPERIORITY|||||||0.0015|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0015
70930533|NCT04490109|141359645|SUPERIORITY|||||||0.0003|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0003
70930534|NCT04490109|141359646|SUPERIORITY|||||||0.0195|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0195
70930535|NCT04490109|141359647|SUPERIORITY|||||||0.0365|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0365
70930536|NCT04490109|141359648|SUPERIORITY|||||||0.0086|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0086
70930537|NCT04490109|141359648|SUPERIORITY|||||||0.0035|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0035
70930538|NCT04490109|141359649|SUPERIORITY|||||||0.0074|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0074
70930539|NCT04490109|141359649|SUPERIORITY|||||||0.0008|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0008
70930540|NCT03904576|141359658|OTHER||Difference of least squares means (T-R)|-7.305|STANDARD_ERROR_OF_MEAN|2.082|||TWO_SIDED|90.0|-10.949|-3.661||||||Mixed effects model including effects for 'treatment', 'period' and 'subject' as well as covariates 'period baseline' and 'subject baseline'.||-3.661|-10.949|
70930541|NCT03904576|141359658|OTHER||Difference in %|-24.396|||||||||||||Difference of least squares means in % (ratio to Placebo) (T-R)/R\*100%|Mixed effects model including effects for 'treatment', 'period' and 'subject' as well as covariates 'period baseline' and 'subject baseline'.||||
70930542|NCT04780581|141359659|EQUIVALENCE|log-rank statistic test.|Odds Ratio (OR)|1.0||||0.984|TWO_SIDED|95.0|0.2|5.1|||Log Rank|||Null hypothesis of equal survival curves. Estimates of rate and risk ratios are shown with 95% confidence intervals. All the p-values are 2-sided and shown without adjustment for multiple testing, and p \< 0.05 was considered statistically significant. The analyses were performed using IBM SPSS Statistics for Windows, Version 26.0 (Armonk, NY, USA: IBM Corp.).||5.1|0.2|0.984
70930543|NCT04780581|141359659|EQUIVALENCE|Log-rank method|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-8.8|9.1||||||||9.1|-8.8|
70930544|NCT04780581|141359660|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|1.1||||0.833|TWO_SIDED|95.0|0.4|3.0|||Chi-squared|||||3.0|0.4|0.833
71050565|NCT01150890|141607432|SUPERIORITY|||||||0.304|||||||ANCOVA|ANCOVA model adjusted for baseline CDAI score.||||||0.3040
70930545|NCT04780581|141359660|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|-1.4|||||TWO_SIDED|95.0|-14.2|11.5||||||||11.5|-14.2|
70930546|NCT04780581|141359661|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|1.5||||0.661|TWO_SIDED|95.0|0.2|9.3|||Chi-squared|||non-invasive mechanical ventilation||9.3|0.2|0.661
70930547|NCT04780581|141359661|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|1.5|||||TWO_SIDED|95.0|-10.2|6.9||||||non-invasive mechanical ventilation||6.9|-10.2|
70930548|NCT04780581|141359661|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|0.7||||0.549|TWO_SIDED|95.0|0.2|2.2|||Chi-squared|||high-flow oxygen requirements||2.2|0.2|0.549
71050566|NCT01822574|141607438|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||ANOVA|||A p-value less than 0.05 was considered statistically significant.||||0.001
71050567|NCT01822574|141607439|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||A p-value less than 0.05 was considered statistically significant.||||<0.001
71050568|NCT01822574|141607440|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||ANOVA|||A p-value less than 0.05 was considered statistically significant.||||0.240
71050569|NCT03982199|141607451|SUPERIORITY||Event Rate|80.0||||4e-05|TWO_SIDED|94.211|52.2|92.9|||Poisson regression|||Case Definition 1||92.9|52.2|0.00004
71050570|NCT03982199|141607451|SUPERIORITY||Event Rate|75.0||||1e-05|TWO_SIDED|94.211|50.1|88.5|||Poisson regression|||Case Definition 2||88.5|50.1|0.00001
71050571|NCT03982199|141607451|SUPERIORITY||Event Rate|69.8||||4e-05|TWO_SIDED|94.211|43.7|84.7|||Poisson regression|||Case Definition 3||84.7|43.7|0.00004
71050572|NCT03107026|141607523|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.187||0.1187|TWO_SIDED|95.0|-0.66|0.08|||Mixed Models Analysis|||||0.08|-0.66|0.1187
71050573|NCT03107026|141607523|SUPERIORITY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.192||0.0045|TWO_SIDED|95.0|-0.93|-0.17|||Mixed Models Analysis|||||-0.17|-0.93|0.0045
71050574|NCT03107026|141607524|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.162||0.0256|TWO_SIDED|95.0|-0.68|-0.04|||Mixed Models Analysis|||||-0.04|-0.68|0.0256
71050575|NCT03107026|141607524|SUPERIORITY||Median Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.166||0.0025|TWO_SIDED|95.0|-0.83|-0.18|||Mixed Models Analysis|||||-0.18|-0.83|0.0025
71050576|NCT03107026|141607525|SUPERIORITY||Odds Ratio (OR)|1.16||||0.5342|TWO_SIDED|95.0|0.726|1.854|||Regression, Logistic|||||1.854|0.726|0.5342
71016843|NCT03692078|141541620|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.106||||0.9835|TWO_SIDED|95.0|-0.475|0.263|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.263|-0.475|0.9835
71050577|NCT03107026|141607525|SUPERIORITY||Odds Ratio (OR)|1.179||||0.4905|TWO_SIDED|95.0|0.738|1.882|||Regression, Logistic|||||1.882|0.738|0.4905
71050578|NCT03107026|141607526|SUPERIORITY||Mean Difference (Final Values)|-2.3|STANDARD_ERROR_OF_MEAN|0.946||0.0154|TWO_SIDED|95.0|-4.16|-0.44|||Mixed Models Analysis|||||-0.44|-4.16|0.0154
71050579|NCT03107026|141607526|SUPERIORITY||Mean Difference (Net)|-3.4|STANDARD_ERROR_OF_MEAN|0.969||0.0005|TWO_SIDED|95.0|-5.31|-1.5|||Mixed Models Analysis|||||-1.50|-5.31|0.0005
71050580|NCT04709835|141607569|SUPERIORITY||Difference in Adjusted Means|-0.11|STANDARD_ERROR_OF_MEAN|0.292||0.7144|TWO_SIDED|80.0|-0.49|0.27|||ANCOVA||A difference in adjusted means of \<0 favors RO7496998 (AT-527).|Day 3||0.27|-0.49|0.7144
71050581|NCT04709835|141607569|SUPERIORITY||Difference in Adjusted Means|0.32|STANDARD_ERROR_OF_MEAN|0.327||0.3373|TWO_SIDED|80.0|-0.11|0.74|||ANCOVA||A difference in adjusted means of \<0 favors RO7496998 (AT-527).|Day 5||0.74|-0.11|0.3373
71050582|NCT04709835|141607569|SUPERIORITY||Difference in Adjusted Means|-0.25|STANDARD_ERROR_OF_MEAN|0.315||0.426|TWO_SIDED|80.0|-0.66|0.16|||ANCOVA||A difference in adjusted means of \<0 favors RO7496998 (AT-527).|Day 7||0.16|-0.66|0.4260
71050583|NCT04709835|141607570|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|80.0|0.53|1.74|||||Hazard ratio (80% CI) was estimated with a Cox proportional hazards model (unadjusted).|||1.74|0.53|
71050584|NCT04709835|141607570|SUPERIORITY||Hazard Ratio (HR)|1.33|||||TWO_SIDED|80.0|0.76|2.32|||||Hazard ratio (80% CI) was estimated with a Cox proportional hazards model (unadjusted).|||2.32|0.76|
71050585|NCT04709835|141607571|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|80.0|0.44|1.7|||||Hazard ratio (80% CI) was estimated with a Cox proportional hazards model (unadjusted).|||1.70|0.44|
71050586|NCT04709835|141607571|SUPERIORITY||Hazard Ratio (HR)|1.06|||||TWO_SIDED|80.0|0.56|2.03|||||Hazard ratio (80% CI) was estimated with a Cox proportional hazards model (unadjusted).|||2.03|0.56|
71050587|NCT04709835|141607572|SUPERIORITY||Difference in Percentage of Positivity|5.0|||||TWO_SIDED|80.0|-0.16|10.16|||||Confidence interval estimated with the Farrington-Manning method.|Day 3||10.16|-0.16|
71105043|NCT00879398|141717119|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|Chi-squared|||Comparison among Duration of Disease: \<1 week, 1 to 8 weeks, 8 to 16 weeks, and ≥16 weeks.||||<0.0001
71050588|NCT04709835|141607572|SUPERIORITY||Difference in Percentage of Positivity|-1.9|||||TWO_SIDED|80.0|-9.2|5.41|||||Confidence interval estimated with the Farrington-Manning method.|Day 3||5.41|-9.20|
71050589|NCT04709835|141607572|SUPERIORITY||Difference in Percentage of Positivity|5.79|||||TWO_SIDED|80.0|-4.82|16.4|||||Confidence interval estimated with the Farrington-Manning method.|Day 5||16.40|-4.82|
71050590|NCT04709835|141607572|SUPERIORITY||Difference in Percentage of Positivity|-0.88|||||TWO_SIDED|80.0|-12.4|10.65|||||Confidence interval estimated with the Farrington-Manning method.|Day 5||10.65|-12.40|
71050591|NCT04709835|141607572|SUPERIORITY||Difference in Percentage of Positivity|2.39|||||TWO_SIDED|80.0|-10.64|15.42|||||Confidence interval estimated with the Farrington-Manning method.|Day 7||15.42|-10.64|
71050592|NCT04709835|141607572|SUPERIORITY||Difference in Percentage of Positivity|-0.26|||||TWO_SIDED|80.0|-13.39|12.88|||||Confidence interval estimated with the Farrington-Manning method.|Day 7||12.88|-13.39|
71050593|NCT04709835|141607584|SUPERIORITY||Difference in Adjusted Means|-0.1|STANDARD_ERROR_OF_MEAN|0.294||0.7351|TWO_SIDED|80.0|-0.48|0.28|||ANCOVA||A difference in adjusted means of \<0 favors RO7496998 (AT-527).|Day 3||0.28|-0.48|0.7351
71050594|NCT04709835|141607584|SUPERIORITY||Difference in Adjusted Means|-0.1|STANDARD_ERROR_OF_MEAN|0.31||0.7524|TWO_SIDED|80.0|-0.5|0.3|||ANCOVA||A difference in adjusted means of \<0 favors RO7496998 (AT-527).|Day 5||0.30|-0.50|0.7524
71050595|NCT04709835|141607584|SUPERIORITY||Difference in Adjusted Means|-0.08|STANDARD_ERROR_OF_MEAN|0.314||0.8083|TWO_SIDED|80.0|-0.48|0.33|||ANCOVA||A difference in adjusted means of \<0 favors RO7496998 (AT-527).|Day 7||0.33|-0.48|0.8083
71050596|NCT04711902|141607601|OTHER|estimation and confidence interval|Marginal difference|39.91|||||TWO_SIDED|95.0|10.87|68.95|||Regression, Logistic|||||68.95|10.87|
71050597|NCT04711902|141607602|OTHER|estimation and confidence interval|Marginal difference|11.86|||||TWO_SIDED|95.0|-7.18|30.91|||Regression, Logistic|||||30.91|-7.18|
71050598|NCT04711902|141607603|OTHER|estimation and confidence interval|Mixed model repeated measures (MMRM)|-1.1|||||TWO_SIDED|95.0|-1.68|-0.52|||Mixed Models Analysis|||||-0.52|-1.68|
71050599|NCT04711902|141607604|OTHER|estimation and confidence interval|Mixed model repeated measures (MMRM)|-1.65|||||TWO_SIDED|95.0|-2.35|-0.94|||Mixed Models Analysis|||||-0.94|-2.35|
71050600|NCT04711902|141607605|OTHER|estimation and confidence interval|Mixed model repeated scores (MMRM)|4.2|||||TWO_SIDED|95.0|0.94|7.46|||Mixed Models Analysis|||||7.46|0.94|
71050601|NCT04711902|141607606|OTHER|estimation and confidence interval|Mixed model repeated measures (MMRM)|-0.4|||||TWO_SIDED|95.0|-0.58|-0.21|||Mixed Models Analysis|||||-0.21|-0.58|
71050602|NCT00415194|141607689|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.082|TWO_SIDED|95.0|0.75|1.02|||Stratified Log Rank|||||1.02|0.75|0.082
71050603|NCT00415194|141607690|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.166|TWO_SIDED|95.0|0.76|1.03|||Stratified Log Rank|||||1.03|0.76|0.166
71050604|NCT00415194|141607691|SUPERIORITY_OR_OTHER|||||||0.061||95.0|||||Unadjusted normal distribution|p-value is based on an unadjusted, normal distribution approximation for differences in rates.||||||0.061
71050605|NCT00415194|141607692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.811|TWO_SIDED|95.0|0.56|1.53|||Stratified Log Rank|||||1.53|0.56|0.811
71050606|NCT00415194|141607693|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.2|TWO_SIDED|95.0|0.69|1.07|||Stratified Log Rank|||||1.07|0.69|0.20
71105044|NCT00879398|141717119|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|Chi-squared|||Past OAB Treatment History: Yes vs Past OAB Treatment History: No||||<0.0001
71105045|NCT00879398|141717119|SUPERIORITY_OR_OTHER|||||||0.1147||95.0||||Statistical significant level: 0.05|Chi-squared|||Medical History of Past Disease: Yes vs Medical History of Past Disease: No||||0.1147
71016844|NCT03692078|141541620|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.348||||0.0854|TWO_SIDED|95.0|-0.725|0.029|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.029|-0.725|0.0854
71050607|NCT01297465|141607695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.28|STANDARD_ERROR_OF_MEAN|0.947|||TWO_SIDED|95.0|-3.15|0.59|||ANOVA|ANOVA model adjusted for treatment and country|The primary efficacy variable was to be analyzed using an analysis of variance (ANOVA) model, adjusted for treatment and country.|The null hypothesis was that the difference between the mean number of oocytes is less than (-3) or greater than (+3) between the two treatment arm. The alternate hypothesis was that the difference is between (-3) and (+3). The study had 80% power to show that the group randomized to Pergoveris® has an absolute difference of no more than 3 oocytes retrieved in comparison to the group randomized to GONAL-f®/Pergoveris®||0.59|-3.15|
71050608|NCT02397408|141607729|OTHER||||||<|0.008|||||||Wilcoxon (Mann-Whitney)|||||||<.008
71050609|NCT01524679|141607765|SUPERIORITY|The Fisher Test with asymptotic test statistic provided by the analysis software was used.|||||<|0.0001||||||This was the only a priori defined primary endpoint. There was no adjustment for multiple comparisons.|Fisher Exact|There was no adjustment for other variables intended for the primary analysis. Confounding variables were analysed in subsequent analyses.||Nullhypothesis was the equality of response rates of the treatment group and the control group. Treatments were compared by a two-sided Fisher test on a level of significance of 0.05. The study was appropriately powered (80%) for this analysis.||||<0.0001
71050610|NCT01524679|141607766|SUPERIORITY||Mean Difference (Final Values)|0.7525||||0.0957|TWO_SIDED|95.0|0.5382|1.0521|||ANCOVA|||||1.0521|0.5382|0.0957
71050611|NCT01524679|141607767|SUPERIORITY||Mean Difference (Final Values)|0.4621||||0.0005|TWO_SIDED|95.0|0.4621|0.7106|||ANCOVA|||||0.7106|0.4621|0.0005
71050612|NCT00140426|141607776|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.55|TWO_SIDED|95.0|0.41|1.74|||Regression, Cox|Time to reaching ease of eating level 3 assessed using Cox regression as some patients did not reach it during the study.|The hazard ratio is for the placebo group versus the treatment group. A hazard ratio \<1 implies that the placebo group had a lower risk of achieving EOE level 3, although not statistically significant. Achieving EOE level 3 was the desired endpoint.|||1.74|0.41|0.55
71050613|NCT00140426|141607780|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.38|STANDARD_DEVIATION|3.74||0.1|TWO_SIDED||||||t-test, 2 sided|||||||0.10
71050614|NCT00140426|141607780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.45|STANDARD_DEVIATION|20.88|<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
71050615|NCT00140426|141607782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.26||0.47|TWO_SIDED|95.0|-0.71|0.33|||t-test, 2 sided||The mean difference was for placebo - risperidone.|Null hypothesis: no difference in change from baseline to end of treatment for CAPT total score||0.33|-0.71|0.47
71050616|NCT00140426|141607783|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||t-test, 2 sided|||||||0.57
71050617|NCT00140426|141607784|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.50
71050618|NCT00140426|141607785|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||t-test, 2 sided|||||||0.43
71050619|NCT00140426|141607786|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||t-test, 2 sided|||||||0.12
71050620|NCT02149108|141607787|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.49|0.69||Hazard ratio, confidence interval and p-value obtained from log-rank test stratified by regorafenib pre-treatment (yes vs no), time from onset metastatic disease until randomisation (less than 24 months vs 24 months or more ) and region.|Log Rank||Hazard ratio \<1 favors Nintedanib.|||0.69|0.49|<0.0001
71050621|NCT02149108|141607788|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.8659|TWO_SIDED|95.0|0.86|1.19||Hazard ratio, confidence interval and p-value obtained from log-rank test stratified by regorafenib pre-treatment (yes vs no), time from onset metastatic disease until randomisation (less than 24 months vs 24 months or more ) and region.|Log Rank||Hazard ratio below 1 favors Nintedanib.|||1.19|0.86|0.8659
71050622|NCT02149108|141607790|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.96|||<|0.0001|TWO_SIDED|95.0|2.0|4.47||Odds ratio and p-value are obtained from logistic regression model adjusted for regorafenib pre-treatment (yes vs no), time from onset metastatic disease until randomization in the trial (less than 24 months vs. 24 months or more) and region.|Regression, Logistic||An odds ratio \>1 indicates benefit to Nintedanib.|||4.47|2.00|<0.0001
71050623|NCT02393248|141607812|SUPERIORITY|||||||0.2841|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.2841
71050624|NCT02393248|141607812|SUPERIORITY|||||||0.3042|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.3042
71050625|NCT02393248|141607812|SUPERIORITY|||||||0.1259|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.1259
71050626|NCT02393248|141607812|SUPERIORITY|||||||0.8214|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.8214
71050627|NCT02393248|141607812|SUPERIORITY|||||||0.4315|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.4315
71050628|NCT02393248|141607812|SUPERIORITY|||||||0.2595|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.2595
71050629|NCT02393248|141607816|SUPERIORITY|||||||0.8577|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.8577
71050630|NCT02393248|141607816|SUPERIORITY|||||||0.7238|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.7238
71050631|NCT02393248|141607816|SUPERIORITY|||||||0.5923|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.5923
71105046|NCT00879398|141717119|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|Chi-squared|||Medical History of Present Disease: Yes vs Medical History of Present Disease: No||||<0.0001
71050632|NCT02393248|141607816|SUPERIORITY|||||||0.7634|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.7634
71050633|NCT02393248|141607816|SUPERIORITY|||||||0.5749|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.5749
71050634|NCT02393248|141607816|SUPERIORITY|||||||0.6877|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.6877
71050635|NCT02393248|141607820|SUPERIORITY|||||||0.143|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.143
71050636|NCT02393248|141607821|SUPERIORITY|||||||0.0013|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.0013
71050637|NCT02393248|141607822|SUPERIORITY|||||||0.319|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.319
71050638|NCT02393248|141607823|SUPERIORITY|||||||0.128|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.128
71050639|NCT02393248|141607824|SUPERIORITY|||||||0.305|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.305
71016845|NCT03692078|141541622|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.028|||<|0.0001|TWO_SIDED|95.0|2.901|3.154|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||3.154|2.901|<.0001
71016846|NCT03692078|141541622|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.034|||<|0.0001|TWO_SIDED|95.0|2.927|3.141|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||3.141|2.927|<.0001
71016847|NCT03692078|141541622|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.603|||<|0.0001|TWO_SIDED|95.0|2.483|2.722|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||2.722|2.483|<.0001
71050640|NCT02393248|141607825|SUPERIORITY|||||||0.305|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.305
71050641|NCT02393248|141607826|SUPERIORITY|||||||0.772|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.772
71050642|NCT04561375|141607859|SUPERIORITY||Proportional odds ratio|0.37||||0.067|TWO_SIDED|95.0|0.13|1.07|||proportional odds logistic regression|In the analysis, 100 µg and 150 µg were merged as one level since too few cases used 150 µg.||||1.07|0.13|0.067
71050643|NCT04561375|141607860|SUPERIORITY||Mean Difference (Final Values)|10.0||||0.147|TWO_SIDED|97.5|-5.8|26.0|||Regression, Linear|||||26|-5.8|0.147
71050644|NCT04561375|141607861|SUPERIORITY||Mean Difference (Final Values)|8.4||||0.463|TWO_SIDED|97.5|-18.0|34.0|||Regression, Linear|||||34|-18|0.463
71050645|NCT04561375|141607862|SUPERIORITY||Median Difference (Final Values)|-13.0||||0.032|TWO_SIDED|95.0|-25.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|-25|0.032
71050646|NCT00296231|141607873|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||t-test, 2 sided|||Paired Student's t-test was used to compare pre and post intervention pCO2 values.||||0.011
71050647|NCT04647721|141607889|NON_INFERIORITY|Non-inferiority margin of 0.5. The two-sided 95% confidence interval (CI) for the treatment difference was constructed using the repeated-measures analysis of covariance (ANCOVA).|Difference in Least Squares Means|0.03|||||TWO_SIDED|95.0|-0.07|0.12||||||||0.12|-0.07|
71050648|NCT04647721|141607890|OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-6.35|6.35||||||||6.35|-6.35|
71050649|NCT04647721|141607891|OTHER||Risk Difference (RD)|1.75|||||TWO_SIDED|95.0|-3.08|6.74||||||||6.74|-3.08|
71050650|NCT00535587|141607970|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.05|STANDARD_DEVIATION|2.94|<|0.02|TWO_SIDED|95.0|||||ANCOVA|||||||<0.02
71050651|NCT01568320|141607972|SUPERIORITY_OR_OTHER_LEGACY||Freedom from Major adverse events (%)|71.6|||||TWO_SIDED|95.0|59.0|82.0|||||Clopper-Pearson (Exact) Method|||82|59|
71050652|NCT01568320|141607973|SUPERIORITY_OR_OTHER_LEGACY||Survival rate (%)|95.5|||||TWO_SIDED|95.0|87.0|99.0|||||Clopper-Pearson (Exact) Method|||99|87|
71077885|NCT02913105|141664398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.05||||0.159|TWO_SIDED|90.0|0.99|1.11|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 42||1.11|0.99|0.1590
70930549|NCT04780581|141359661|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|3.4|||||TWO_SIDED|95.0|-8.2|15.1||||||high-flow oxygen requirements||15.1|-8.2|
70930550|NCT04780581|141359661|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|1.1||||0.809|TWO_SIDED|95.0|0.4|3.3|||Chi-squared|||Invasive mechanical ventilation or intubation requirements analysis||3.3|0.4|0.809
70930551|NCT04780581|141359661|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-13.0|11.1||||||Invasive mechanical ventilation or intubation requirements analysis||11.1|-13.0|
70930552|NCT04780581|141359662|EQUIVALENCE|T-test|Risk Difference (RD)|-0.3||||0.908|TWO_SIDED|95.0|-5.0|5.0|||t-test, 1 sided|||||5|-5|0.908
70930553|NCT04780581|141359663|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|0.8||||0.758|TWO_SIDED|95.0|0.3|2.5|||Chi-squared|||Secondary infections||2.5|0.3|0.758
70930554|NCT04780581|141359663|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|1.8|||||TWO_SIDED|95.0|-10.1|13.7||||||Secondary infections||13.7|-10.1|
71016848|NCT03692078|141541622|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.567|||<|0.0001|TWO_SIDED|95.0|2.465|2.67|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||2.670|2.465|<.0001
71016849|NCT03692078|141541622|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.716|||<|0.0001|TWO_SIDED|95.0|2.595|2.838|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||2.838|2.595|<.0001
71016850|NCT03692078|141541622|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.643|||<|0.0001|TWO_SIDED|95.0|2.541|2.746|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||2.746|2.541|<.0001
71077886|NCT02913105|141664398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.4256|TWO_SIDED|90.0|0.97|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 56||1.09|0.97|0.4256
71105047|NCT00879398|141717119|SUPERIORITY_OR_OTHER|||||||1||95.0||||Statistical significant level: 0.05|Fisher Exact|||Kidney Disorder: Yes vs Kidney Disorder: No||||1.0000
70930555|NCT04780581|141359663|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|4.2||||0.007|TWO_SIDED|95.0|1.4|12.3|||Chi-squared|||Hyperglycaemia||12.3|1.4|0.007
70930556|NCT04780581|141359663|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|-18.9|||||TWO_SIDED|95.0|-31.8|-5.6||||||Hyperglycaemia||-5.6|-31.8|
70930557|NCT04780581|141359663|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|-1.6||||0.319|TWO_SIDED|95.0|-8.5|4.4|||Chi-squared|||Psychotic states||4.4|-8.5|0.319
70930558|NCT04780581|141359664|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|1.0||||0.962|TWO_SIDED|95.0|0.4|2.3|||Chi-squared|||||2.3|0.4|0.962
70930559|NCT04780581|141359664|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-14.2|14.9||||||||14.9|-14.2|
70930560|NCT04704869|141359681|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.81|1.17||||||||1.17|0.81|
70930561|NCT05785130|141359797|SUPERIORITY|T0|Mean Difference (Final Values)|-25.07||||0.74|TWO_SIDED|||||T0|t-test, 2 sided|||It was calculated that 58 participants were randomized in a 1:1 between two arms on baseline, the first intervention day(T1), the third intervention day(T2), and follow up two days later after intervention (T3) . Sample size was determoned using G-power repeated measures, between factors(α = 0.05, power = 0.8). Assumption a discontinution rate of 10%.||||0.74
70930562|NCT05785130|141359797|SUPERIORITY||Median Difference (Final Values)|133.57||||0.75|TWO_SIDED|||||T1|t-test, 2 sided|||It was calculated that 58 participants were randomized in a 1:1 between two arms on baseline, the first intervention day(T1), the third intervention day(T2), and follow up two days later after intervention (T3) . Sample size was determoned using G-power repeated measures, between factors(α = 0.05, power = 0.8). Assumption a discontinution rate of 10%.||||0.75
70930563|NCT05785130|141359797|SUPERIORITY|T|Median Difference (Final Values)|235.93|||<|0.01|TWO_SIDED|||||T2|t-test, 2 sided|||It was calculated that 58 participants were randomized in a 1:1 between two arms on baseline, the first intervention day(T1), the third intervention day(T2), and follow up two days later after intervention (T3) . Sample size was determoned using G-power repeated measures, between factors(α = 0.05, power = 0.8). Assumption a discontinution rate of 10%.||||<0.01
70930564|NCT05785130|141359797|SUPERIORITY|T3|Median Difference (Final Values)|214.18|||<|0.01|TWO_SIDED|||||T3|t-test, 2 sided|||It was calculated that 58 participants were randomized in a 1:1 between two arms on baseline, the first intervention day(T1), the third intervention day(T2), and follow up two days later after intervention (T3) . Sample size was determoned using G-power repeated measures, between factors(α = 0.05, power = 0.8). Assumption a discontinution rate of 10%.||||<0.01
70930565|NCT03351998|141359798|SUPERIORITY||Mean Difference (Net)|36.02|STANDARD_DEVIATION|365.55||0.6051|TWO_SIDED||||||signed rank test|This is within group 12 month change.||||||0.6051
70930566|NCT03351998|141359798|SUPERIORITY||Mean Difference (Net)|31.89|STANDARD_DEVIATION|213.0||0.9434|TWO_SIDED||||||signed rank test|This is within group 12 month change.||||||0.9434
71050653|NCT00546572|141608000|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.17|1.88|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 1: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.88|1.17|
71050654|NCT00546572|141608000|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.1|||||TWO_SIDED|95.0|0.91|1.35|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 3: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.35|0.91|
71050655|NCT00546572|141608000|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|2.7|||||TWO_SIDED|95.0|1.93|3.74|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 4: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||3.74|1.93|
71050656|NCT00546572|141608000|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|2.0|||||TWO_SIDED|95.0|1.55|2.63|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 5: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.63|1.55|
71050657|NCT00546572|141608000|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|3.0|||||TWO_SIDED|95.0|2.21|4.13|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 6B: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||4.13|2.21|
70850751|NCT04518995|141189581|SUPERIORITY||Risk Difference (RD)|0.32|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001|TWO_SIDED|95.0|0.23|0.42||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.42|0.23|< 0.0001
70930567|NCT03351998|141359798|SUPERIORITY||Mean Difference (Net)|-3.39|STANDARD_DEVIATION|179.54||0.9408|TWO_SIDED||||||t-test, 2 sided|This is within group 12 month change.||||||0.9408
71050658|NCT00546572|141608000|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.07|2.18|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 7F: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.18|1.07|
71050659|NCT00546572|141608000|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|2.0|||||TWO_SIDED|95.0|1.36|2.97|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 9V: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.||2.97|1.36|
71105048|NCT00879398|141717119|SUPERIORITY_OR_OTHER|||||||1||95.0||||Statistical significant level: 0.05|Fisher Exact|||Liver Disorder: Yes vs Liver Disorder: No||||1.0000
71105049|NCT00879398|141717119|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|Chi-squared|||Comparison among Total Administration Period of Toviaz Subgroups: \<2 months, 2 to 4 months, and ≥4 months.||||<0.0001
70930568|NCT03351998|141359799|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|0.23||0.7458|TWO_SIDED||||||t-test, 2 sided|This is within group 12 month change.||||||0.7458
70930569|NCT03351998|141359799|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_DEVIATION|0.16||0.4056|TWO_SIDED||||||t-test, 2 sided|This is within group 12 month change.||||||0.4056
70850752|NCT04518995|141189581|SUPERIORITY||Risk Difference (RD)|0.35|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|0.27|0.42||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.42|0.27|< 0.0001
70930570|NCT03351998|141359799|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_DEVIATION|0.18||0.1932|TWO_SIDED||||||t-test, 2 sided|This is within group 12 month change.||||||0.1932
70930571|NCT03533257|141359814|SUPERIORITY|||||||0.3654|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.3654
71050660|NCT00546572|141608000|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.0|||||TWO_SIDED|95.0|0.73|1.33|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 14: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.33|0.73|
71050661|NCT00546572|141608000|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.9|||||TWO_SIDED|95.0|1.42|2.5|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 18C: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.50|1.42|
70930572|NCT03533257|141359815|SUPERIORITY|||||||0.6698|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.6698
70930573|NCT03533257|141359816|SUPERIORITY|||||||0.3086|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.3086
71016851|NCT03692078|141541622|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.235|||<|0.0001|TWO_SIDED|95.0|1.083|1.386|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||1.386|1.083|<.0001
71050662|NCT00546572|141608000|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.8|||||TWO_SIDED|95.0|1.43|2.2|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 19A: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.20|1.43|
71016852|NCT03692078|141541622|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.174|||<|0.0001|TWO_SIDED|95.0|1.045|1.304|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||1.304|1.045|<.0001
71016853|NCT03692078|141541622|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.219|||<|0.0001|TWO_SIDED|95.0|1.07|1.368|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||1.368|1.070|<.0001
71050663|NCT00546572|141608000|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.6|||||TWO_SIDED|95.0|1.17|2.06|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 19F: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.06|1.17|
71077887|NCT02913105|141664398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.4901|TWO_SIDED|90.0|0.96|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 84||1.09|0.96|0.4901
71077888|NCT02913105|141664398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.3648|TWO_SIDED|90.0|0.97|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 112 (EOS)||1.09|0.97|0.3648
71105050|NCT00879398|141717119|SUPERIORITY_OR_OTHER|||||||0.0239||95.0||||Statistical significant level: 0.05|Fisher Exact|||Comparison among Daily Dose of Toviaz: 3 mg, 4 mg, \>4 mg to \<8 mg, and 8 mg.||||0.0239
71105051|NCT00879398|141717119|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|Chi-squared|||Completion vs Discontinuation||||<0.0001
70930574|NCT03533257|141359817|SUPERIORITY|||||||0.5552|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.5552
71016854|NCT03692078|141541622|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.176|||<|0.0001|TWO_SIDED|95.0|1.046|1.306|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||1.306|1.046|<.0001
71016855|NCT03692078|141541622|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.176|||<|0.0001|TWO_SIDED|95.0|1.029|1.322|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||1.322|1.029|<.0001
71016856|NCT03692078|141541622|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.174|||<|0.0001|TWO_SIDED|95.0|1.049|1.3|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||1.300|1.049|<.0001
71016857|NCT03692078|141541622|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.425|||<|0.0001|TWO_SIDED|95.0|-0.669|-0.181|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.181|-0.669|<.0001
71016858|NCT03692078|141541622|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.467|||<|0.0001|TWO_SIDED|95.0|-0.677|-0.256|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.256|-0.677|<.0001
71016859|NCT03692078|141541622|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.311||||0.0052|TWO_SIDED|95.0|-0.556|-0.066|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.066|-0.556|0.0052
71016860|NCT03692078|141541622|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.391|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.182|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.182|-0.600|<.0001
71016861|NCT03692078|141541622|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.793|||<|0.0001|TWO_SIDED|95.0|-2.07|-1.516|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.516|-2.070|<.0001
71077889|NCT02913105|141664398|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.01||||0.8891|TWO_SIDED|90.0|0.91|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 7||1.12|0.91|0.8891
70930575|NCT03533257|141359818|SUPERIORITY|||||||0.0361|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.0361
71105052|NCT00879398|141717119|SUPERIORITY_OR_OTHER|||||||0.5889||95.0||||Statistical significant level: 0.05|Fisher Exact|||Total Administration Period \<274 days vs Total Administration Period ≥ 274 days||||0.5889
70930576|NCT03533257|141359819|SUPERIORITY|||||||0.3585|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.3585
70930577|NCT03533257|141359820|SUPERIORITY|||||||0.8996|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.8996
70930578|NCT01651000|141359854|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70930579|NCT01651000|141359855|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70930580|NCT01651000|141359856|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70930581|NCT03982186|141359858|SUPERIORITY||Difference of proportions|-2.3|||=|0.848|TWO_SIDED|90.0|-5.97|1.38|||Mantel Haenszel|||||1.38|-5.97|= 0.848
70930582|NCT03982186|141359858|SUPERIORITY||Difference of proportions|7.4|||=|0.027|TWO_SIDED|90.0|1.07|13.68|||Mantel Haenszel|||||13.68|1.07|= 0.027
70930583|NCT03982186|141359858|SUPERIORITY||Difference of proportions|9.1|||=|0.917|TWO_SIDED|90.0|4.16|14.07|||Mantel Haenszel|||||14.07|4.16|= 0.917
70930584|NCT03982186|141359858|SUPERIORITY||Difference of proportions|-6.7|||=|0.917|TWO_SIDED|90.0|-14.67|1.25|||Mantel Haenszel|||||1.25|-14.67|= 0.917
70930585|NCT02765412|141359898|OTHER|multilevel model|Odds Ratio (OR)|0.67||||0.081|TWO_SIDED|95.0|0.58|0.78||Two-sided test; the a priori threshold being 0.05|Regression, Logistic|Adjusts for age, gender, race, comorbidities, implementation group, travel distance, and VAMC indicator|OR corresponding to the interaction between implementation group and lung cancer risk, a ratio of odds ratios. The OR for screening based on lung cancer risk in the SI group versus the OR for screening based on lung cancer risk in the II group|||0.78|0.58|0.081
70930586|NCT02765412|141359899|OTHER||Median Difference (Net)|-0.15||||0.35|TWO_SIDED|95.0|-0.16|0.46||Two-sided test; the a priori threshold being 0.05|t-test, 2 sided||Satisfaction rating on a scale of 0 to 10; Difference is Arm 1 - Arm 2|Simple t-test comparing mean satisfaction ratings between arms||0.46|-0.16|0.35
70930587|NCT04244175|141359910|SUPERIORITY|RRatio was analyzed using an analysis of covariance (ANCOVA) model including treatment and the Baseline seizure frequency per week as a covariate.|LS Mean Difference|0.11|||=|0.986|TWO_SIDED|90.0|-10.38|10.61|||ANCOVA||CVL-865 25 mg BID - Placebo|CVL-865 25 mg BID vs Placebo||10.61|-10.38|=0.986
70930588|NCT04244175|141359910|SUPERIORITY|RRatio was analyzed using an analysis of covariance (ANCOVA) model including treatment and the Baseline seizure frequency per week as a covariate.|LS Mean Difference|1.42|||=|0.823|TWO_SIDED|90.0|-9.04|11.87|||ANCOVA||CVL-865 7.5 mg BID - Placebo|CVL-865 7.5 mg BID vs Placebo||11.87|-9.04|=0.823
70930589|NCT04244175|141359910|SUPERIORITY|RRatio was analyzed using an analysis of covariance (ANCOVA) model including treatment and the Baseline seizure frequency per week as a covariate.|LS Mean Difference|0.76|||=|0.888|TWO_SIDED|90.0|-8.23|9.76|||ANCOVA||CVL-865 7.5 mg BID / 25 mg BID - Placebo|CVL-865 7.5 mg BID / 25 mg BID vs Placebo||9.76|-8.23|=0.888
70930590|NCT04244175|141359911|SUPERIORITY|The percent reduction relative to Placebo was calculated.|Percent reduction relative to Placebo|4.9|||||TWO_SIDED|90.0|-12.0|19.3||||||CVL-865 25 mg BID vs Placebo||19.3|-12.0|
70930591|NCT04244175|141359911|SUPERIORITY|The percent reduction relative to Placebo was calculated.|Percent reduction relative to Placebo|1.4|||||TWO_SIDED|90.0|-16.1|16.2||||||CVL-865 7.5 mg BID vs Placebo||16.2|-16.1|
70930592|NCT04244175|141359911|SUPERIORITY|The percent reduction relative to Placebo was calculated.|Percent reduction relative to Placebo|3.2|||||TWO_SIDED|90.0|-11.4|15.8||||||CVL-865 7.5 mg BID / 25 mg BID vs Placebo||15.8|-11.4|
70930593|NCT04244175|141359912|SUPERIORITY|A logistic regression with treatment group and Baseline seizure frequency as covariates was used to calculate the Odds ratio, 90% confidence interval, and p-value.|Odds Ratio (OR)|1.27|||=|0.587|TWO_SIDED|90.0|0.616|2.618|||Regression, Logistic|||CVL-865 25 mg BID vs Placebo||2.618|0.616|=0.587
71016862|NCT03692078|141541622|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.859|||<|0.0001|TWO_SIDED|95.0|-2.098|-1.621|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.621|-2.098|<.0001
71016863|NCT03692078|141541622|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.809|||<|0.0001|TWO_SIDED|95.0|-2.082|-1.535|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.535|-2.082|<.0001
71050664|NCT00546572|141608000|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|3.7|||||TWO_SIDED|95.0|2.69|5.09|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 23F: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||5.09|2.69|
71105053|NCT00879398|141717119|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Statistical significant level: 0.05|Chi-squared|||Concurrent Medication: Yes vs Concurrent Medication: No||||0.0010
70850753|NCT04518995|141189581|SUPERIORITY||Risk Difference (RD)|0.39|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|0.3|0.48||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.48|0.30|< 0.0001
70850754|NCT04518995|141189581|SUPERIORITY||Risk Difference (RD)|0.34|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|0.26|0.42||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.42|0.26|< 0.0001
70850755|NCT04518995|141189581|SUPERIORITY||Risk Difference (RD)|0.42|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|0.34|0.51||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.51|0.34|< 0.0001
70850756|NCT04518995|141189581|SUPERIORITY||Risk Difference (RD)|0.37|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|0.29|0.44||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.44|0.29|< 0.0001
70850757|NCT04518995|141189581|SUPERIORITY||Risk Difference (RD)|0.44|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|0.35|0.53||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.53|0.35|< 0.0001
70850758|NCT04518995|141189582|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 12||-0.5|-0.9|<0.0001
70850759|NCT04518995|141189582|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score|MMRM|||Satisfied Thickness Hair Coverage: Week 12||-0.7|-1.2|<0.0001
70850760|NCT04518995|141189582|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.1|-0.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score|MMRM|||Satisfied Thickness Hair Coverage: Week 16||-0.6|-1.1|<0.0001
70850761|NCT04518995|141189582|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.4|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score|MMRM|||Satisfied Thickness Hair Coverage: Week 16||-1.0|-1.4|<0.0001
70850762|NCT04518995|141189582|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 20||-0.8|-1.2|<0.0001
70850763|NCT04518995|141189582|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 20||-1.1|-1.6|<0.0001
70850764|NCT04518995|141189582|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 24||-0.8|-1.3|<0.0001
70850765|NCT04518995|141189582|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.7|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 24||-1.2|-1.7|<0.0001
70850766|NCT04518995|141189582|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.8|-0.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 12||-0.4|-0.8|<0.0001
70850767|NCT04518995|141189582|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 12||-0.7|-1.1|<0.0001
70850768|NCT04518995|141189582|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 16||-0.5|-0.9|<0.0001
70850769|NCT04518995|141189582|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 16||-0.8|-1.3|<0.0001
70850770|NCT04518995|141189582|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 20||-0.7|-1.1|<0.0001
70850771|NCT04518995|141189582|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 20||-1.0|-1.5|<0.0001
70850772|NCT04518995|141189582|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 24||-0.7|-1.2|<0.0001
70930594|NCT04244175|141359912|SUPERIORITY|A logistic regression with treatment group and Baseline seizure frequency as covariates was used to calculate the Odds ratio, 90% confidence interval, and p-value.|Odds Ratio (OR)|1.303|||=|0.554|TWO_SIDED|90.0|0.624|2.723|||Regression, Logistic|||CVL-865 7.5 mg BID vs Placebo||2.723|0.624|=0.554
71016864|NCT03692078|141541622|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.858|||<|0.0001|TWO_SIDED|95.0|-2.096|-1.621|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.621|-2.096|<.0001
71016865|NCT03692078|141541622|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|1.427|||<|0.0001|TWO_SIDED|95.0|1.166|1.688|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.688|1.166|<.0001
71016866|NCT03692078|141541622|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|1.393|||<|0.0001|TWO_SIDED|95.0|1.166|1.62|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.620|1.166|<.0001
71016867|NCT03692078|141541622|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|1.541|||<|0.0001|TWO_SIDED|95.0|1.278|1.803|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.803|1.278|<.0001
71050665|NCT00546572|141608001|SUPERIORITY_OR_OTHER||difference in proportions|43.8|||||TWO_SIDED|95.0|37.4|49.9|||||Exact 2-sided CI (based on Chan and Zhang) for the difference in proportions, 13vPnC - 23vPS expressed as a percentage.|"Serotype 6A: difference in proportions, 13vPnC - 23vPS, expressed as a percentage.~Statistical significance was shown if the lower limit of the 95% CI for the difference in proportions (13vPnC - 23vPS) was \> 0."||49.9|37.4|
71050666|NCT00546572|141608002|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|9.6|||||TWO_SIDED|95.0|7.0|13.26|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|"Serotype 6A: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.~Statistical significance was demonstrated if the lower limit of the 2-sided 95% confidence interval for the geometric mean ratio was \>2."||13.26|7.00|
71050667|NCT00546572|141608003|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.85|1.1|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 1: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.10|0.85|
71050668|NCT00546572|141608003|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.91|1.11|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 3: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.11|0.91|
71050669|NCT00546572|141608003|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.68|0.92|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 4: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||0.92|0.68|
71050670|NCT00546572|141608003|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.73|0.94|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 5: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||0.94|0.73|
71105054|NCT00375713|141717120|NON_INFERIORITY_OR_EQUIVALENCE|The pre-set threshold for non inferiority is -10%.|Difference in proportion of responders|0.00069213||||||95.0|-0.0875|0.0888||||||The lower bound of the 95% two sided confidence interval for the difference (Levocetirizine - Cetirizine) in percentage of responders is compared to the pre-set threshold for non inferiority (-10% which is equal to -0.1 for the proportion of responders). Standard method for estimation of the difference in proportions incl. confidence interval using normal approximation is used.||0.0888|-0.0875|
71016868|NCT03692078|141541622|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|1.469|||<|0.0001|TWO_SIDED|95.0|1.243|1.695|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.695|1.243|<.0001
71016869|NCT03692078|141541622|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.059||||0.9987|TWO_SIDED|95.0|-0.233|0.351|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.351|-0.233|0.9987
71016870|NCT03692078|141541622|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.0||||1|TWO_SIDED|95.0|-0.253|0.254|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.254|-0.253|1.0000
71016871|NCT03692078|141541622|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.043||||0.9999|TWO_SIDED|95.0|-0.246|0.332|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.332|-0.246|0.9999
71016872|NCT03692078|141541622|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.002||||1|TWO_SIDED|95.0|-0.251|0.254|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.254|-0.251|1.0000
71016873|NCT03692078|141541624|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.407|||<|0.0001|TWO_SIDED|95.0|2.283|2.531|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||2.531|2.283|<.0001
71050671|NCT00546572|141608003|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.03|1.4|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 6A: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.40|1.03|
71050672|NCT00546572|141608003|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.02|1.35|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 6B: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.35|1.02|
71050673|NCT00546572|141608003|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.65|1.01|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 7F: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.01|0.65|
71050674|NCT00546572|141608003|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.69|1.15|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 9V: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.15|0.69|
71105055|NCT00375713|141717121|SUPERIORITY_OR_OTHER|||||||0.4369||95.0|||||ANCOVA|Pruritus score is adjusted on pruritus Baseline score.||The mean daily pruritus score at Day 14 visit or at study completion was analyzed using an analysis of covariance (ANCOVA) model, including pruritus severity score of the day before the randomization as a covariate and treatment group as a factor||||0.4369
70930595|NCT04244175|141359912|SUPERIORITY|A logistic regression with treatment group and Baseline seizure frequency as covariates was used to calculate the Odds ratio, 90% confidence interval, and p-value.|Odds Ratio (OR)|1.286|||=|0.513|TWO_SIDED|90.0|0.684|2.42|||Regression, Logistic|||CVL-865 7.5 mg BID / 25 mg BID vs Placebo||2.420|0.684|=0.513
70930596|NCT04244175|141359913|SUPERIORITY|The p-value is from Fisher's exact test for number of responders.|||||>|0.999|||||||Fisher's exact test|||CVL-865 25 mg BID vs Placebo||||>0.999
70930597|NCT04244175|141359913|SUPERIORITY|The p-value is from Fisher's exact test for number of responders.|||||=|0.618|||||||Fisher's exact test|||CVL-865 7.5 mg BID vs Placebo||||=0.618
70930598|NCT04244175|141359913|SUPERIORITY|The p-value is from Fisher's exact test for number of responders.|||||=|0.422|||||||Fisher's exact test|||CVL-865 7.5 mg BID / 25 mg BID vs Placebo||||=0.422
70930599|NCT04244175|141359915|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.5|||=|0.021|TWO_SIDED|90.0|-0.8|-0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 15)|CVL-865 25 mg BID vs Placebo (Day 15)||-0.1|-0.8|=0.021
70930600|NCT04244175|141359915|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.2|||=|0.342|TWO_SIDED|90.0|-0.5|0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 15)|CVL-865 7.5 mg BID vs Placebo (Day 15)||0.1|-0.5|=0.342
70930601|NCT04244175|141359915|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.059|TWO_SIDED|90.0|-0.6|0.0|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 15)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 15)||0.0|-0.6|=0.059
70930602|NCT04244175|141359915|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.5|||=|0.04|TWO_SIDED|90.0|-0.9|-0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 43)|CVL-865 25 mg BID vs Placebo (Day 43)||-0.1|-0.9|=0.040
70930603|NCT04244175|141359915|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.4|||=|0.152|TWO_SIDED|90.0|-0.8|0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 43)|CVL-865 7.5 mg BID vs Placebo (Day 43)||0.1|-0.8|=0.152
70930604|NCT04244175|141359915|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.4|||=|0.044|TWO_SIDED|90.0|-0.8|-0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 43)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 43)||-0.1|-0.8|=0.044
70930605|NCT04244175|141359915|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.199|TWO_SIDED|90.0|-0.7|0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 71)|CVL-865 25 mg BID vs Placebo (Day 71)||0.1|-0.7|=0.199
70930606|NCT04244175|141359915|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.171|TWO_SIDED|90.0|-0.7|0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 71)|CVL-865 7.5 mg BID vs Placebo (Day 71)||0.1|-0.7|=0.171
71016874|NCT03692078|141541624|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.398|||<|0.0001|TWO_SIDED|95.0|2.253|2.543|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||2.543|2.253|<.0001
71016875|NCT03692078|141541624|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.303|||<|0.0001|TWO_SIDED|95.0|2.187|2.42|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||2.420|2.187|<.0001
71105056|NCT00375713|141717122|SUPERIORITY_OR_OTHER|||||||0.3549||95.0|||||ANCOVA|pruritus severity score at baseline has been used as a covariate.||The categorized duration of Pruritus at endpoint during the 14 day treatment period was analyzed using an analysis of covariance (ANCOVA) model, including pruritus severity score of the day before the randomization as a covariate and treatment group as a factor.||||0.3549
70941550|NCT02229396|141383845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.74|STANDARD_ERROR_OF_MEAN|5.168|<|0.001|TWO_SIDED|95.0|-37.89|-17.59|||ANCOVA|Treatment, region, and baseline HbA1c stratum (\<9.0% or ≥9.0%), as fixed factors; baseline value as covariate.||||-17.59|-37.89|<0.001
71050675|NCT00546572|141608003|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.79|1.05|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 14: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.05|0.79|
71016876|NCT03692078|141541624|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.25|||<|0.0001|TWO_SIDED|95.0|2.112|2.389|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||2.389|2.112|<.0001
71016877|NCT03692078|141541624|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.285|||<|0.0001|TWO_SIDED|95.0|2.166|2.404|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||2.404|2.166|<.0001
71016878|NCT03692078|141541624|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.272|||<|0.0001|TWO_SIDED|95.0|2.133|2.412|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||2.412|2.133|<.0001
71016879|NCT03692078|141541624|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.992|||<|0.0001|TWO_SIDED|95.0|1.844|2.14|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||2.140|1.844|<.0001
71016880|NCT03692078|141541624|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.894|||<|0.0001|TWO_SIDED|95.0|1.719|2.069|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||2.069|1.719|<.0001
71016881|NCT03692078|141541624|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.102|||<|0.0001|TWO_SIDED|95.0|1.955|2.248|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||2.248|1.955|<.0001
71016882|NCT03692078|141541624|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.075|||<|0.0001|TWO_SIDED|95.0|1.9|2.25|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||2.250|1.900|<.0001
71016883|NCT03692078|141541624|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.89|||<|0.0001|TWO_SIDED|95.0|1.746|2.033|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||2.033|1.746|<.0001
71105057|NCT00375713|141717123|SUPERIORITY_OR_OTHER|||||||0.7518||95.0|||||Cochran-Mantel-Haenszel|stratified on the prurity severity score at the previous day of randomization.||||||0.7518
71016884|NCT03692078|141541624|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.944|||<|0.0001|TWO_SIDED|95.0|1.775|2.114|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||2.114|1.775|<.0001
71016885|NCT03692078|141541624|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.104||||0.8674|TWO_SIDED|95.0|-0.345|0.137|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||0.137|-0.345|0.8674
71016886|NCT03692078|141541624|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.148||||0.6519|TWO_SIDED|95.0|-0.429|0.133|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||0.133|-0.429|0.6519
71016887|NCT03692078|141541624|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.122||||0.7301|TWO_SIDED|95.0|-0.363|0.119|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.119|-0.363|0.7301
71016888|NCT03692078|141541624|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.126||||0.8076|TWO_SIDED|95.0|-0.405|0.154|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.154|-0.405|0.8076
71016889|NCT03692078|141541624|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.415||||0.0004|TWO_SIDED|95.0|-0.689|-0.142|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.142|-0.689|0.0004
71016890|NCT03692078|141541624|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.504||||0.0002|TWO_SIDED|95.0|-0.822|-0.185|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.185|-0.822|0.0002
71050676|NCT00546572|141608003|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.97|1.23|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 18C: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.23|0.97|
70850773|NCT04518995|141189582|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 24||-1.0|-1.5|<0.0001
71016891|NCT03692078|141541624|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.306||||0.0183|TWO_SIDED|95.0|-0.578|-0.034|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.034|-0.578|0.0183
71016892|NCT03692078|141541624|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.323||||0.0443|TWO_SIDED|95.0|-0.641|-0.005|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.005|-0.641|0.0443
71016893|NCT03692078|141541624|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.414||||0.0002|TWO_SIDED|95.0|0.155|0.672|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||0.672|0.155|0.0002
71016894|NCT03692078|141541624|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.306||||0.0454|TWO_SIDED|95.0|0.004|0.608|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||0.608|0.004|0.0454
71016895|NCT03692078|141541624|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.396||||0.0004|TWO_SIDED|95.0|0.136|0.655|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||0.655|0.136|0.0004
71050677|NCT00546572|141608003|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.89|1.07|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 19A: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.07|0.89|
70850774|NCT04518995|141189582|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 12||-0.5|-0.9|< 0.0001
70850775|NCT04518995|141189582|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.1|-0.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 12||-0.6|-1.1|< 0.0001
70850776|NCT04518995|141189582|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 16||-0.7|-1.1|< 0.0001
70850777|NCT04518995|141189582|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 16||-0.9|-1.4|< 0.0001
70850778|NCT04518995|141189582|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 20||-0.7|-1.1|< 0.0001
70850779|NCT04518995|141189582|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 20||-0.9|-1.3|< 0.0001
70850780|NCT04518995|141189582|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 24||-0.8|-1.2|< 0.0001
70930607|NCT04244175|141359915|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.125|TWO_SIDED|90.0|-0.7|0.0|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 71)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 71)||0.0|-0.7|=0.125
70930608|NCT04244175|141359916|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|0.0|||=|0.767|TWO_SIDED|90.0|-0.3|0.2|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 15)|CVL-865 25 mg BID vs Placebo (Day 15)||0.2|-0.3|=0.767
70930609|NCT04244175|141359916|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|0.2|||=|0.178|TWO_SIDED|90.0|0.0|0.5|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 15)|CVL-865 7.5 mg BID vs Placebo (Day 15)||0.5|0.0|=0.178
70930610|NCT04244175|141359916|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|0.1|||=|0.542|TWO_SIDED|90.0|-0.1|0.3|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 15)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 15)||0.3|-0.1|=0.542
70930611|NCT04244175|141359916|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.106|TWO_SIDED|90.0|-0.6|0.0|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 43)|CVL-865 25 mg BID vs Placebo (Day 43)||0.0|-0.6|=0.106
70930612|NCT04244175|141359916|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|0.1|||=|0.663|TWO_SIDED|90.0|-0.2|0.4|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 43)|CVL-865 7.5 mg BID vs Placebo (Day 43)||0.4|-0.2|=0.663
70930613|NCT04244175|141359916|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.1|||=|0.488|TWO_SIDED|90.0|-0.4|0.2|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 43)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 43)||0.2|-0.4|=0.488
70930614|NCT04244175|141359916|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.1|TWO_SIDED|90.0|-0.7|0.0|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 71)|CVL-865 25 mg BID vs Placebo (Day 71)||0.0|-0.7|=0.100
70930615|NCT04244175|141359916|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|0.0|||=|0.969|TWO_SIDED|90.0|-0.3|0.3|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 71)|CVL-865 7.5 mg BID vs Placebo (Day 71)||0.3|-0.3|=0.969
70930616|NCT04244175|141359916|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.2|||=|0.344|TWO_SIDED|90.0|-0.4|0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 71)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 71)||0.1|-0.4|=0.344
70930617|NCT04244175|141359917|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.4|||=|0.01|TWO_SIDED|90.0|-0.7|-0.2|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 15)|CVL-865 25 mg BID vs Placebo (Day 15)||-0.2|-0.7|=0.010
71016896|NCT03692078|141541624|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.328||||0.0261|TWO_SIDED|95.0|0.026|0.63|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||0.630|0.026|0.0261
70930618|NCT04244175|141359917|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.1|||=|0.376|TWO_SIDED|90.0|-0.4|0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 15)|CVL-865 7.5 mg BID vs Placebo (Day 15)||0.1|-0.4|=0.376
70930619|NCT04244175|141359917|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.044|TWO_SIDED|90.0|-0.5|-0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 15)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 15)||-0.1|-0.5|=0.044
70930620|NCT04244175|141359917|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.6|||=|0.005|TWO_SIDED|90.0|-1.0|-0.3|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 43)|CVL-865 25 mg BID vs Placebo (Day 43)||-0.3|-1.0|=0.005
70930621|NCT04244175|141359917|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.1|||=|0.549|TWO_SIDED|90.0|-0.5|0.2|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 43)|CVL-865 7.5 mg BID vs Placebo (Day 43)||0.2|-0.5|=0.549
70930622|NCT04244175|141359917|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.4|||=|0.048|TWO_SIDED|90.0|-0.7|-0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 43)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 43)||-0.1|-0.7|=0.048
70930623|NCT04244175|141359917|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.6|||=|0.005|TWO_SIDED|90.0|-1.0|-0.3|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 71)|CVL-865 25 mg BID vs Placebo (Day 71)||-0.3|-1.0|=0.005
70930624|NCT04244175|141359917|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.1|||=|0.549|TWO_SIDED|90.0|-0.5|0.2|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 71)|CVL-865 7.5 mg BID vs Placebo (Day 71)||0.2|-0.5|=0.549
70930625|NCT04244175|141359917|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.4|||=|0.048|TWO_SIDED|90.0|-0.7|-0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 71)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 71)||-0.1|-0.7|=0.048
70930626|NCT04244175|141359918|SUPERIORITY|Changes from Baseline in QOLIE-31 Overall Scores was compared using an ANCOVA model with the Baseline score as a covariate and treatment group included in the model as fixed effects in the mITT population. This estimand included available post-Baseline response data that occurred before discontinuation of treatment or the addition of rescue medication.|LS Mean Difference|-0.49|||=|0.829|TWO_SIDED|90.0|-4.23|3.26|||ANCOVA||CVL-865 25 mg BID - Placebo|CVL-865 25 mg BID vs Placebo||3.26|-4.23|=0.829
70850781|NCT04518995|141189582|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 24||-0.9|-1.4|< 0.0001
70850782|NCT04518995|141189582|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.7|-0.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 12||-0.3|-0.7|< 0.0001
70850783|NCT04518995|141189582|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.8|-0.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 12||-0.4|-0.8|< 0.0001
70850784|NCT04518995|141189582|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 16||-0.5|-0.9|< 0.0001
70850785|NCT04518995|141189582|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 16||-0.7|-1.1|< 0.0001
70850786|NCT04518995|141189582|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 20||-0.5|-0.9|< 0.0001
71016897|NCT03692078|141541624|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.102||||0.9455|TWO_SIDED|95.0|-0.187|0.392|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.392|-0.187|0.9455
71016898|NCT03692078|141541624|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.05||||0.9999|TWO_SIDED|95.0|-0.387|0.287|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.287|-0.387|0.9999
71016899|NCT03692078|141541624|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.212||||0.2633|TWO_SIDED|95.0|-0.074|0.498|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.498|-0.074|0.2633
71016900|NCT03692078|141541624|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.13||||0.8769|TWO_SIDED|95.0|-0.205|0.465|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.465|-0.205|0.8769
71016901|NCT03692078|141541626|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (PP Population)|Mean Difference (Net)|5.417|||<|0.0001|TWO_SIDED|95.0|5.315|5.52|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (PP Population)||5.520|5.315|<.0001
71016902|NCT03692078|141541626|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (PP Population)|Mean Difference (Net)|5.436|||<|0.0001|TWO_SIDED|95.0|5.324|5.548|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (PP Population)||5.548|5.324|<.0001
71016903|NCT03692078|141541626|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (PP Population)|Mean Difference (Net)|4.957|||<|0.0001|TWO_SIDED|95.0|4.86|5.053|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (PP Population)||5.053|4.860|<.0001
71050678|NCT00546572|141608003|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.83|1.15|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 19F: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.15|0.83|
70850787|NCT04518995|141189582|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.0|-0.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 20||-0.5|-1.0|< 0.0001
70850788|NCT04518995|141189582|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.1|-0.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 24||-0.6|-1.1|< 0.0001
70850789|NCT04518995|141189582|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 24||-0.7|-1.2|< 0.0001
70930627|NCT04244175|141359918|SUPERIORITY|Changes from Baseline in QOLIE-31 Overall Scores was compared using an ANCOVA model with the Baseline score as a covariate and treatment group included in the model as fixed effects in the mITT population. This estimand included available post-Baseline response data that occurred before discontinuation of treatment or the addition of rescue medication.|LS Mean Difference|-0.2|||=|0.927|TWO_SIDED|90.0|-3.87|3.46|||ANCOVA||CVL-865 7.5 mg BID - Placebo|CVL-865 7.5 mg BID vs Placebo||3.46|-3.87|=0.927
70930628|NCT04244175|141359918|SUPERIORITY|Changes from Baseline in QOLIE-31 Overall Scores was compared using an ANCOVA model with the Baseline score as a covariate and treatment group included in the model as fixed effects in the mITT population. This estimand included available post-Baseline response data that occurred before discontinuation of treatment or the addition of rescue medication.|LS Mean Difference|-0.35|||=|0.859|TWO_SIDED|90.0|-3.57|2.88|||ANCOVA||CVL-865 7.5 mg BID / 25 mg BID - Placebo|CVL-865 7.5 mg BID / 25 mg BID vs Placebo||2.88|-3.57|=0.859
70930629|NCT04244175|141359919|SUPERIORITY|The Least Square Means (LS Means), difference in LS Means, 90% confidence interval for the difference, and the p-value for the difference are from an analysis of covariance (ANCOVA) model with fixed effects for treatment and Baseline score.|LS Mean Difference|-0.013|||=|0.788|TWO_SIDED|90.0|-0.096|0.069|||ANCOVA||CVL-865 25 mg BID - Placebo (HUI-2)|CVL-865 25 mg BID vs Placebo (HUI-2)||0.069|-0.096|=0.788
70930630|NCT04244175|141359919|SUPERIORITY|The Least Square Means (LS Means), difference in LS Means, 90% confidence interval for the difference, and the p-value for the difference are from an analysis of covariance (ANCOVA) model with fixed effects for treatment and Baseline score.|LS Mean Difference|0.077|||=|0.126|TWO_SIDED|90.0|-0.006|0.16|||ANCOVA||CVL-865 7.5 mg BID - Placebo (HUI-2)|CVL-865 7.5 mg BID vs Placebo (HUI-2)||0.160|-0.006|=0.126
70930631|NCT04244175|141359919|SUPERIORITY|The Least Square Means (LS Means), difference in LS Means, 90% confidence interval for the difference, and the p-value for the difference are from an analysis of covariance (ANCOVA) model with fixed effects for treatment and Baseline score.|LS Mean Difference|0.032|||=|0.461|TWO_SIDED|90.0|-0.039|0.103|||ANCOVA||CVL-865 7.5 mg BID / 25 mg BID - Placebo (HUI-2)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (HUI-2)||0.103|-0.039|=0.461
70930632|NCT04244175|141359919|SUPERIORITY|The Least Square Means (LS Means), difference in LS Means, 90% confidence interval for the difference, and the p-value for the difference are from an analysis of covariance (ANCOVA) model with fixed effects for treatment and Baseline score.|LS Mean Difference|-0.032|||=|0.661|TWO_SIDED|90.0|-0.154|0.089|||ANCOVA||CVL-865 25 mg BID - Placebo (HUI-3)|CVL-865 25 mg BID vs Placebo (HUI-3)||0.089|-0.154|=0.661
70930633|NCT04244175|141359919|SUPERIORITY|The Least Square Means (LS Means), difference in LS Means, 90% confidence interval for the difference, and the p-value for the difference are from an analysis of covariance (ANCOVA) model with fixed effects for treatment and Baseline score.|LS Mean Difference|0.115|||=|0.124|TWO_SIDED|90.0|-0.008|0.237|||ANCOVA||CVL-865 7.5 mg BID - Placebo (HUI-3)|CVL-865 7.5 mg BID vs Placebo (HUI-3)||0.237|-0.008|=0.124
70930634|NCT04244175|141359919|SUPERIORITY|The Least Square Means (LS Means), difference in LS Means, 90% confidence interval for the difference, and the p-value for the difference are from an analysis of covariance (ANCOVA) model with fixed effects for treatment and Baseline score.|LS Mean Difference|0.041|||=|0.518|TWO_SIDED|90.0|-0.064|0.146|||ANCOVA||CVL-865 7.5 mg BID / 25 mg BID - Placebo (HUI-3)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (HUI-3)||0.146|-0.064|=0.518
70930635|NCT03781089|141359948|OTHER|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||||||0.024
70930636|NCT03781089|141359949|OTHER|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||||||0.024
70930637|NCT04310423|141359970|OTHER|||||||0.036|||||||Mixed Models Analysis|||Treatment x Time interaction for alcohol cue-induced alcohol craving.||||0.036
70930638|NCT04310423|141359971|OTHER||||||>|0.05|||||||Mixed Models Analysis|||Two-way Treatment x Time interaction||||>0.05
71050679|NCT00546572|141608003|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.6|2.14|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 23F: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||2.14|1.60|
70930639|NCT04310423|141359972|OTHER||||||>|0.05|||||||Mixed Models Analysis|||Treatment x Time interactions||||>0.05
70930640|NCT04310423|141359973|OTHER||||||>|0.05|||||||Mixed Models Analysis|||Treatment x Time interactions||||>0.05
70930641|NCT04310423|141359974|OTHER||||||<|0.001|||||||ANCOVA|||Main effect of treatment on alcohol cue-elicited brain activation||||<0.001
70930642|NCT02777593|141359989|OTHER|Performance goal tested using Exact method calculation to estimate the 95% one-sided lower confidence level (95% LCL) on the proportion of participants with primary endpoint success. If the 95% LCL exceeded 0.64, then the the null hypothesis was to be rejected and the PG was met.|95% Exact Lower Confidence Limit|0.751|||||ONE_SIDED|||||||||"Primary endpoint success was defined as the proportion of analysis-eligible participants without a primary endpoint event and with 12-Month imaging performed.~Results were tested against a performance goal (PG) of 0.64 (i.e. 64%), derived from historical GORE TAG® and Conformable TAG® data.~Additionally, using a one-sided alpha of 0.05 and Exact Test, minimum power of 80%, the sample needed was 70 patients. With attrition, 85 patients were required."||||
70930643|NCT03547271|141360005|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) was \>1/1.5 for all 4 serogroups.|GMT ratio|0.69|||||TWO_SIDED|95.0|0.565|0.842|||||95% CI of the GMT ratio was calculated using a normal approximation of log-transformed titers.|Statistical analysis for Serogroup A||0.842|0.565|
70930644|NCT03547271|141360005|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>1/1.5 for all 4 serogroups.|GMT ratio|4.73|||||TWO_SIDED|95.0|4.0|5.58|||||95% CI of the GMT ratio was calculated using a normal approximation of log-transformed titers.|Statistical analysis for Serogroup C||5.58|4.00|
70930645|NCT03547271|141360005|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>1/1.5 for all 4 serogroups.|Slope|1.54|||||TWO_SIDED|95.0|1.33|1.78|||||95% CI of the GMT ratio was calculated using a normal approximation of log-transformed titers.|Statistical analysis for Serogroup W||1.78|1.33|
70930646|NCT03547271|141360005|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>1/1.5 for all 4 serogroups.|GMT ratio|1.78|||||TWO_SIDED|95.0|1.55|2.04|||||95% CI of the GMT ratio was calculated using a normal approximation of log-transformed titers.|Statistical analysis for Serogroup Y||2.04|1.55|
70930647|NCT03547271|141360006|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups.|Difference in percentage of participants|-12.2|||||TWO_SIDED|95.0|-17.74|-6.56|||||95% CI of the difference was calculated from the Wilson score method without continuity correction.|Statistical analysis for Serogroup A||-6.56|-17.74|
70930648|NCT03547271|141360006|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups.|Difference in percentage of participants|6.89|||||TWO_SIDED|95.0|4.44|9.62|||||95% CI of the difference was calculated from the Wilson score method without continuity correction.|Statistical analysis for Serogroup C||9.62|4.44|
70930649|NCT03547271|141360006|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups.|Difference in percentage of participants|2.07|||||TWO_SIDED|95.0|-0.49|4.7|||||95% CI of the difference was calculated from the Wilson score method without continuity correction|Statistical analysis for Serogroup W||4.70|-0.49|
70930650|NCT03547271|141360006|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups.|Difference in percentage of participants|3.01|||||TWO_SIDED|95.0|0.34|5.77|||||95% CI of the difference was calculated from the Wilson score method without continuity correction.|Statistical analysis for Serogroup Y||5.77|0.34|
70930651|NCT04835363|141360023|SUPERIORITY|||||||0.029|||||||ANOVA|||||||0.029
70930652|NCT04835363|141360024|SUPERIORITY|||||||0.148|||||||ANOVA|||||||0.148
70930653|NCT04835363|141360025|SUPERIORITY|||||||0.012|||||||ANOVA|||||||0.012
70930654|NCT04835363|141360026|SUPERIORITY|||||||0.078|||||||ANOVA|||||||0.078
70930655|NCT04835363|141360027|SUPERIORITY|||||||0.011|||||||ANOVA|||||||0.011
70930656|NCT04835363|141360028|SUPERIORITY|||||||0.797|||||||ANOVA|||||||0.797
70930657|NCT04835363|141360029|SUPERIORITY|||||||0.358|||||||ANOVA|||||||0.358
71105058|NCT02769481|141717161|NON_INFERIORITY|A 95% CI was to be calculated to estimate the range of values in which the treatment difference was likely to lie. If the 95% CI fell below the specified non inferiority margin of 0.35%, the non inferiority of bexagliflozin treatment to glimepiride treatment would be demonstrated and the null hypothesis would be rejected.|Mean Difference (Final Values)|0.05|||||TWO_SIDED|95.0|-0.21|0.11|||||A lower value represents a better treatment effect.|The null hypothesis for the primary endpoint was that the change in HbA1c from baseline to week 60 in the bexagliflozin arm would be greater than change in the glimepiride arm by greater than 0.35%.||0.11|-0.21|
70930658|NCT04835363|141360030|SUPERIORITY|||||||0.055|||||||ANOVA|||||||0.055
71105059|NCT02769481|141717162|SUPERIORITY||Difference of LS Means|-4.31|||<|0.0001|TWO_SIDED|95.0|-5.1|-3.52||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, background treatment, baseline HbA1c, baseline eGFR, treatment, visit, treatment-by-visit and baseline weight as a fixed effect covariate.||||-3.52|-5.10|< 0.0001
71105060|NCT02769481|141717163|SUPERIORITY||Difference of LS Means|-6.53||||0.0008|TWO_SIDED|95.0|-10.56|-2.51||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, background treatment, baseline HbA1c, baseline eGFR, treatment, visit, treatment-by-visit and baseline weight as a fixed effect covariate.||||-2.51|-10.56|0.0008
70930659|NCT04835363|141360031|SUPERIORITY|||||||0.496|||||||ANOVA|||||||0.496
70930660|NCT04835363|141360032|SUPERIORITY|||||||0.241|||||||ANOVA|||||||0.241
70930661|NCT04835363|141360033|SUPERIORITY|||||||0.004|||||||ANOVA|||||||0.004
70930662|NCT04835363|141360034|SUPERIORITY|||||||0.019|||||||ANOVA|||||||0.019
70930663|NCT04835363|141360035|SUPERIORITY|||||||0.141|||||||ANOVA|||ENGAGEMENT STRATEGIES||||0.141
70930664|NCT04835363|141360035|SUPERIORITY|||||||0.496|||||||ANOVA|||DISENGAGEMENT STRATEGIES||||0.496
70930665|NCT02532621|141360044|NON_INFERIORITY|"Cumulative patency at 6 months was evaluated using the estimated patency from a Kaplan Meier survival analysis. The test statistic took the following form:~Z-test statistic = (P - 0.75) / SE (P) Where, (P) represents the Kaplan Meier estimate of cumulative patency at 6 months, and the standard error SE (P) is estimated using the method of Peto et al (1977)."|Cumulative patency|92.1|||<|0.001|ONE_SIDED|95.0||||A one-sided p-value of 0.025 was considered evidence of statistical significance for the primary study endpoint.|one-sided binomial exact test|||"The primary endpoint was evaluated by comparison with a performance goal of 75% that was determined from medical literature.~The sample size of 158 patients was estimated as follows:~* Kaplan-Meier estimate of cumulative patency rate at 6 months (exact binomial estimation for sample size)~* Type I error (alpha): 0.025 (one-sided)~* 80% Statistical power~* 8% Lost-to-follow up rate"||||<0.001
70930666|NCT02360371|141360064|SUPERIORITY|||||||0.567|||||||Mixed methods|||||||0.567
70930667|NCT02360371|141360065|SUPERIORITY|||||||0.805|||||||Mixed Model|||||||0.805
70930668|NCT04881110|141360085|SUPERIORITY||Mean Difference (Final Values)|11.2|||<|0.001|TWO_SIDED|95.0|8.0|14.5|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|14.5|8.0|<0.001
70941551|NCT02229396|141383845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.78|STANDARD_ERROR_OF_MEAN|5.09|<|0.001|TWO_SIDED|95.0|-36.78|-16.78|||ANCOVA|Treatment, region, and baseline HbA1c stratum (\<9.0% or ≥9.0%), as fixed factors; baseline value as covariate.||||-16.78|-36.78|<0.001
70941552|NCT02229396|141383846|SUPERIORITY_OR_OTHER||Difference in percentages|19.7|||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (\<9.0% or ≥9.0%).||||||<0.001
70850790|NCT04518995|141189583|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.2489|TWO_SIDED|95.0|-0.2|0.9||P-value was calculated by analysis of covariance (ANCOVA) analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Anxiety||0.9|-0.2|0.2489
70930669|NCT04881110|141360085|SUPERIORITY||Risk Ratio (RR)|1.91|||<|0.001|TWO_SIDED|95.0|1.26|2.9|||Chi-squared||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|2.90|1.26|<0.001
71016904|NCT03692078|141541626|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (PP Population)|Mean Difference (Net)|4.974|||<|0.0001|TWO_SIDED|95.0|4.867|5.081|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (PP Population)||5.081|4.867|<.0001
71016905|NCT03692078|141541626|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (PP Population)|Mean Difference (Net)|4.984|||<|0.0001|TWO_SIDED|95.0|4.886|5.082|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (PP Population)||5.082|4.886|<.0001
71016906|NCT03692078|141541626|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (PP Population)|Mean Difference (Net)|4.975|||<|0.0001|TWO_SIDED|95.0|4.868|5.082|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (PP Population)||5.082|4.868|<.0001
71016907|NCT03692078|141541626|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (PP Population)|Mean Difference (Net)|3.49|||<|0.0001|TWO_SIDED|95.0|3.367|3.612|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (PP Population)||3.612|3.367|<.0001
71016908|NCT03692078|141541626|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (PP Population)|Mean Difference (Net)|3.347|||<|0.0001|TWO_SIDED|95.0|3.212|3.483|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (PP Population)||3.483|3.212|<.0001
71105061|NCT02769481|141717164|SUPERIORITY||Odds Ratio (OR)|0.12|||<|0.0001|TWO_SIDED|95.0|0.05|0.28||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Logistic|Region, baseline HbA1c, background treatment, eGFR at baseline, treatment as a fixed effect covariate.|Odds ratio is calculated as the odds ratio of bexagliflozin over glimepiride.|||0.28|0.05|< 0.0001
70930670|NCT04881110|141360086|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.06|TWO_SIDED|95.0|-0.8|0.01|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|0.01|-0.8|0.06
70930671|NCT04881110|141360087|SUPERIORITY||Mean Difference (Final Values)|-3.4||||0.52|TWO_SIDED|95.0|-14.3|7.4|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|7.4|-14.3|0.52
70941553|NCT02229396|141383846|SUPERIORITY_OR_OTHER||Difference in percentages|13.3||||0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (\<9.0% or ≥9.0%).||||||0.001
70941554|NCT02229396|141383847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.26|STANDARD_ERROR_OF_MEAN|3.494|<|0.001|TWO_SIDED|95.0|-27.12|-13.4|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-13.40|-27.12|<0.001
70850791|NCT04518995|141189583|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.32||0.1235|TWO_SIDED|95.0|-0.1|1.1||P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Anxiety||1.1|-0.1|0.1235
70930672|NCT04881110|141360088|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.33|TWO_SIDED|95.0|-3.6|1.2|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|1.2|-3.6|0.33
70930673|NCT04881110|141360089|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.1|TWO_SIDED|95.0|-1.7|0.1|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|0.1|-1.7|0.10
70930674|NCT04881110|141360090|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.81|TWO_SIDED|95.0|-2.8|3.5|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|3.5|-2.8|0.81
70930675|NCT04881110|141360091|SUPERIORITY||Mean Difference (Final Values)|-0.003||||0.99|TWO_SIDED|95.0|-5.8|5.8|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|5.8|-5.8|0.99
70930676|NCT04881110|141360092|SUPERIORITY||Mean Difference (Final Values)|-4.8||||0.72|TWO_SIDED|95.0|-32.6|22.9|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|22.9|-32.6|0.72
70930677|NCT04881110|141360093|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.02|TWO_SIDED|95.0|-0.7|-0.07|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|-0.07|-0.7|0.02
70930678|NCT04881110|141360094|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.12|TWO_SIDED|95.0|-0.04|0.3|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|0.3|-0.04|0.12
70930679|NCT04881110|141360095|SUPERIORITY||Mean Difference (Final Values)|-3.09||||0.25|TWO_SIDED|95.0|-8.5|2.3|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|2.3|-8.5|0.25
70930680|NCT04881110|141360096|SUPERIORITY||Mean Difference (Final Values)|87.4|||<|0.001|TWO_SIDED|95.0|59.9|115.1|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|115.1|59.9|<0.001
70930681|NCT04881110|141360097|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.18|TWO_SIDED|95.0|-0.09|0.01|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|0.01|-0.09|0.18
70941555|NCT02229396|141383847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.03|STANDARD_ERROR_OF_MEAN|3.477|<|0.001|TWO_SIDED|95.0|-21.85|-8.2||This is a nominal p-value.|Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-8.20|-21.85|<0.001
70941556|NCT02229396|141383848|SUPERIORITY_OR_OTHER||Difference in percentages|17.9|||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (\<9.0% or ≥9.0%).||||||<0.001
70930682|NCT04881110|141360098|SUPERIORITY||Mean Difference (Final Values)|8.7||||0.06|TWO_SIDED|95.0|-0.6|18.1|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|18.1|-0.6|0.06
70930683|NCT04881110|141360099|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.06|TWO_SIDED|95.0|-0.09|2.6|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|2.6|-0.09|0.06
70930684|NCT04881110|141360101|SUPERIORITY||Mean Difference (Final Values)|25.1|||<|0.001|TWO_SIDED|95.0|21.8|28.3|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|28.3|21.8|<0.001
70930685|NCT02933489|141360134|EQUIVALENCE|H0: DBT = AB-MR|Wald interval with Bonett-Price Laplace|0.007||||0.002|TWO_SIDED|95.0|0.0022|0.0116|||McNemar||"Wald interval with Bonett-Price Laplace, described in :~Fagerland MW, Lydersen S, Laake P. Recommended tests and confidence intervals for paired binomial proportions. Statist. Med. 2014; 33:2850-75."|The proportion of participants who had an invasive cancer, verified by pathology, detected by each modality (the invasive cancer detection rates) will be made using exact McNemar's test.||0.0116|0.0022|0.002
70930686|NCT02933489|141360135|EQUIVALENCE|PPV DBT = PPV AB-MR||||||0.15||||||"Generalized estimating equation (GEE) regression with the p-value from the resulting score test.~5 secondary comparisons were planned: alpha level of 0.05/5 = 0.01 for p-value significance"|Leisenring|Leisenring W, Alonzo T, Pepe MS. Comparisons of predictive values of binary medical diagnostic tests for paired designs. Biometrics. 2000;56:345-351||Positive Predictive Value (PPV)||||0.15
70930687|NCT02933489|141360136|EQUIVALENCE|H0: DBT short term follow-up rate = AB-MR short term follow-up rate|||||<|0.0001||||||To adjust for multiplicity, using the Bonferroni correction, secondary comparisons are compared against an adjusted alpha level of 0.05/5=0.01 corresponding to the 5 secondary comparisons outlined in the Statistical Analysis Plan (SAP)|McNemar|exact p-value||The exact p-value from McNemar's test is reported for for comparing the DBT against the AB-MR short term follow-up rates||||<0.0001
70930688|NCT02933489|141360136|EQUIVALENCE|H0: DBT additional imaging rate =AB-MR additional imaging rate||||||0.02||||||To adjust for multiplicity, using the Bonferroni correction, secondary comparisons are compared against an adjusted alpha level of 0.05/5 = 0.01, corresponding to the 5 secondary comparisons outlined in the SAP|McNemar|exact p-values||The exact p-value from McNemar's test is reported for for comparing the DBT against the AB-MR additional imaging rates||||0.02
70930689|NCT02933489|141360137|EQUIVALENCE|Sensitivity DBT = Sensitivity AB-MR||||||0.001||||||The comparison of the sensitivity of AB-MR and DBT uses a two-sided exact McNemar's test to account for the paired design 5 secondary comparisons were planned: alpha level of 0.05/5 = 0.01 for p-value significance|McNemar|||||||0.001
70930690|NCT02933489|141360137|EQUIVALENCE|Specificity DBT = Specificity AB-MR|||||<|0.001||||||The comparison of the Specificity of AB-MR and DBT uses a two-sided exact McNemar's test to account for the paired design 5 secondary comparisons were planned: alpha level of 0.05/5 = 0.01 for p-value significance|McNemar|||||||<0.001
71016909|NCT03692078|141541626|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (PP Population)|Mean Difference (Net)|3.539|||<|0.0001|TWO_SIDED|95.0|3.418|3.66|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (PP Population)||3.660|3.418|<.0001
71016910|NCT03692078|141541626|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (PP Population)|Mean Difference (Net)|3.419|||<|0.0001|TWO_SIDED|95.0|3.284|3.554|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (PP Population)||3.554|3.284|<.0001
71016911|NCT03692078|141541626|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (PP Population)|Mean Difference (Net)|3.492|||<|0.0001|TWO_SIDED|95.0|3.373|3.611|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (PP Population)||3.611|3.373|<.0001
71079480|NCT00482170|141666450|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.022|TWO_SIDED|95.0|1.06|2.21||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.21|1.06|0.022
70941557|NCT02229396|141383848|SUPERIORITY_OR_OTHER||Difference in percentages|25.6|||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (\<9.0% or ≥9.0%).||||||<0.001
70941558|NCT02229396|141383849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|1.08||0.005|TWO_SIDED|95.0|-5.2|-0.9|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-0.9|-5.2|0.005
71105062|NCT02769481|141717165|SUPERIORITY|Superiority of bexagliflozin over glimepiride in HbA1c reduction from baseline to week 60 will be declared if the upper bound of 95% confidence interval is less than 0|Difference of LS Means|-0.05|||||TWO_SIDED|95.0|-0.21|0.11||||||||0.11|-0.21|
71105063|NCT04604431|141717182|SUPERIORITY||Odds Ratio (OR)|14.1|||<|0.001|TWO_SIDED|95.0|6.9|29.1|||Mixed Models Analysis|||Odds ratios will be computed to describe the odds of adherence for the iREACH intervention compared to the control intervention for low-risk infants.||29.1|6.9|<0.001
71105064|NCT04604431|141717182|SUPERIORITY||Odds Ratio (OR)|3.1||||0.034|TWO_SIDED|95.0|1.1|8.8|||Mixed Models Analysis|||Odds ratios will be computed to describe the odds of adherence for the iREACH intervention compared to the control intervention for high-risk infants.||8.8|1.1|0.034
71105065|NCT04603560|141717187|SUPERIORITY||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.54|1.66|||||The odds ratio represents Social Norming vs Control.|Generalized estimating equation adjusting for clustering of patients within providers as well as provider panel size||1.66|0.54|
71105066|NCT04603560|141717187|SUPERIORITY||Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.72|2.29|||||The odds ratio represents Pharmacist E-Detailing vs Control.|Generalized estimating equation adjusting for clustering of patients within providers as well as provider panel size||2.29|0.72|
71105067|NCT04603560|141717187|SUPERIORITY||Odds Ratio (OR)|1.38|||||TWO_SIDED|95.0|0.74|2.56|||||The odds ratio represents Pharmacist e-detailing vs Social Norming.|Generalized estimating equation adjusting for clustering of patients within providers as well as provider panel size.||2.56|0.74|
70850792|NCT04518995|141189583|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.9765|TWO_SIDED|95.0|-0.5|0.5||P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Depression||0.5|-0.5|0.9765
70850793|NCT04518995|141189583|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.3559|TWO_SIDED|95.0|-0.3|0.8||P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Depression||0.8|-0.3|0.3559
70850794|NCT04518995|141189584|SUPERIORITY||Risk Difference (RD)|0.21|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.16|0.25||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.25|0.16|<0.0001
70850795|NCT04518995|141189584|SUPERIORITY||Risk Difference (RD)|0.33|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.27|0.39||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.39|0.27|<0.0001
70850796|NCT02891070|141189594|NON_INFERIORITY|To demonstrate non-inferiority (NI) of Tisseel to DuraSeal for the primary endpoint, the lower limit of the 95% CI (based on normal approximation) for the difference in average predicted proportions had to be greater than -10%.|Mean Difference (Net)|-9.29|||||TWO_SIDED|95.0|-21.11|2.54|||Regression, Logistic||Difference in Average Predicted Proportion (Tisseel - Duraseal)|||2.54|-21.11|
70850797|NCT02891070|141189596|OTHER||Mean Difference (Net)|-9.29|||||TWO_SIDED|95.0|-21.11|2.54|||Regression, Logistic||Difference in Average Predicted Proportion (Tisseel - Duraseal)|||2.54|-21.11|
70850798|NCT02891070|141189597|OTHER|||||||0.0241|||||||Wilcoxon (Mann-Whitney)|||||||0.0241
70850799|NCT02891070|141189598|OTHER|||||||0.1015|||||||Wilcoxon (Mann-Whitney)|||||||0.1015
70850800|NCT02891070|141189599|OTHER|||||||0.9943|||||||Wilcoxon (Mann-Whitney)|||||||0.9943
70850801|NCT02891070|141189600|OTHER||Mean Difference (Net)|-5.11|||||TWO_SIDED|95.0|-13.6|3.39|||Regression, Logistic|||||3.39|-13.60|
70850802|NCT04491604|141189601|EQUIVALENCE|The Hypothesis was tested by exact McNemar's test on the paired primary wound healing data.|responder rate difference|45.8||||0.00192|TWO_SIDED|95.0|23.6|68.0|||McNemar|The Hypothesis was tested by exact McNemar's test on the paired primary wound healing data. A multiple imputation approach was used for missing data.|The difference is the treatment/discordance difference in percentage of responders (primary wounds with complete healing), which is the same as the difference in the percentage of treatment responders and the percentage of placebo responders.|The null hypothesis of interest was the absence of a treatment effect on wound healing and the alternative hypothesis is the presence of a treatment effect on wound healing. The Hypothesis was tested by exact McNemar's test on the paired primary wound healing data. For subjects with missing primary wound healing data, a multiple imputation approach was used.||68.0|23.6|0.00192
70850803|NCT04491604|141189602|EQUIVALENCE|The Hypothesis was tested by exact McNemar's test on the paired primary wound healing data.|responder rate difference|51.0||||0.00047|TWO_SIDED|95.0|29.3|72.6||There is no multiplicity adjustment needed since the hypothesis testing are hierarchical.|McNemar|The Hypothesis was tested by exact McNemar's test on the paired primary wound healing data. A multiple imputation approach was used for missing data.|The difference is the treatment/discordance difference in percentage of responders (complete wound healing), which is the same as the difference in the percentage of treatment responders and the percentage of placebo responders.|The null hypothesis of interest was the absence of a treatment effect on wound healing and the alternative hypothesis is the presence of a treatment effect on wound healing. The Hypothesis was tested by exact McNemar's test on the paired primary wound healing data. For subjects with missing primary wound healing data, a multiple imputation approach was used.||72.6|29.3|0.00047
70850804|NCT04248491|141189609|SUPERIORITY|||||||0.342|||||||t-test, 2 sided|||||||0.342
70850805|NCT04248491|141189610|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||0.035
70850806|NCT04248491|141189612|SUPERIORITY|||||||0.098|||||||t-test, 2 sided|||||||0.098
70850807|NCT04248491|141189614|SUPERIORITY|||||||0.192|||||||t-test, 2 sided|||||||0.192
70850808|NCT04248491|141189615|SUPERIORITY|||||||0.157|||||||t-test, 2 sided|||||||0.157
70850809|NCT04248491|141189616|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.00
70850810|NCT04248491|141189617|SUPERIORITY|||||||0.463|||||||t-test, 2 sided|||||||0.463
70850811|NCT04248491|141189618|SUPERIORITY|||||||0.799|||||||t-test, 2 sided|||||||0.799
70850812|NCT04248491|141189619|SUPERIORITY|||||||0.757|||||||t-test, 2 sided|||||||0.757
70930691|NCT02994927|141360144|NON_INFERIORITY|The proportion of subjects achieving disease remission at Week 26 and the two-sided 95% confidence intervals (CIs) for the difference in proportions was estimated for the comparison between the avacopan group and the prednisone group. For both the noninferiority and superiority tests, the one-sided P-values are presented. Statistical significance was claimed based on the one-sided type-I error of 0.025.|Common difference in remission rates|3.4|||<|0.0001|TWO_SIDED|95.0|-6.0|12.8|||Summary score test||Summary Score estimate of the common difference and Miettinen-Nurminen (score) confidence limits for the common difference|||12.8|-6.0|< 0.0001
70930692|NCT02994927|141360144|SUPERIORITY|The proportion of subjects achieving disease remission at Week 26 and the two-sided 95% confidence intervals (CIs) for the difference in proportions was estimated for the comparison between the avacopan group and the prednisone group. For both the noninferiority and superiority tests, the one-sided P-values are presented. Statistical significance was claimed based on the one-sided type-I error of 0.025.|Common difference in remission rates|3.4|||=|0.2387|TWO_SIDED|95.0|-6.0|12.8|||Summary score test||Summary Score estimate of the common difference and Miettinen-Nurminen (score) confidence limits for the common difference|||12.8|-6.0|= 0.2387
71105068|NCT00643279|141717188|SUPERIORITY|Survival estimate at 6-months|6-month survival rate|91.5|||||ONE_SIDED|95.0|88.7||||||||||88.7|
70930693|NCT02994927|141360145|NON_INFERIORITY|The proportion of subjects achieving sustained disease remission at Week 52, and the two-sided 95% confidence intervals (CIs) for the difference in proportions (avacopan minus prednisone) was estimated for the comparison between the avacopan group and the prednisone group. For both the noninferiority and superiority tests, the one-sided P-values are presented. Statistical significance was claimed based on the one-sided type-I error of 0.025.|Common difference in remission rates|12.5|||<|0.0001|TWO_SIDED|95.0|2.6|22.3|||Summary score test||Summary Score estimate of the common difference and Miettinen-Nurminen (score) confidence limits for the common difference|||22.3|2.6|< 0.0001
70930694|NCT02994927|141360145|SUPERIORITY|The proportion of subjects achieving sustained disease remission at Week 52, and the two-sided 95% confidence intervals (CIs) for the difference in proportions (avacopan minus prednisone) was estimated for the comparison between the avacopan group and the prednisone group. For both the noninferiority and superiority tests, the one-sided P-values are presented. Statistical significance was claimed based on the one-sided type-I error of 0.025.|Common difference in remission rates|12.5|||=|0.0066|TWO_SIDED|95.0|2.6|22.3|||Summary score test||Summary Score estimate of the common difference and Miettinen-Nurminen (score) confidence limits for the common difference|||22.3|2.6|= 0.0066
70930695|NCT04243759|141360196|SUPERIORITY|||||||0.97|||||||ANOVA|||||||0.97
70930696|NCT04243759|141360197|SUPERIORITY||Mean Difference (Final Values)|0.36|STANDARD_DEVIATION|2.09||0.232|TWO_SIDED|95.0|-0.24|0.95|||t-test, 2 sided|||Within subjects comparison of drinks per drinking day with full intervention app access versus daily assessment via the app only||0.95|-0.24|.232
70930697|NCT04093869|141360205|SUPERIORITY||Mean Difference (Net)|4.1|STANDARD_ERROR_OF_MEAN|5.1||0.4|TWO_SIDED|95.0|-6.0|14.0||Not adjusted for multiple comparisons. Full alpha of 0.05 was allocated to this as the sole primary outcome.|Regression, Linear||A negative mean difference would represent a better outcome in the CSTEX arm compared to the SOC-ED arm.|||14|-6|0.40
70930698|NCT04093869|141360206|SUPERIORITY||Mean Difference (Net)|20.7|STANDARD_ERROR_OF_MEAN|32.6|||TWO_SIDED|95.0|-44.0|85.0|||||A positive value for the estimate represents a greater distance walked for the CSTEX arm compared to the SOC-ED arm.|||85|-44|
70930699|NCT04093869|141360207|SUPERIORITY||Median Difference (Net)|-316.0|STANDARD_ERROR_OF_MEAN|336.0|||TWO_SIDED|95.0|-979.0|346.0|||||A positive value for the estimate would represent more steps per day for the CSTEX arm compared to the SOC-ED arm.|||346|-979|
70930700|NCT04093869|141360208|SUPERIORITY||Mean Difference (Net)|14.7|STANDARD_ERROR_OF_MEAN|10.0|||TWO_SIDED|95.0|-5.0|34.0||||||||34|-5|
70930701|NCT04093869|141360209|SUPERIORITY||Mean Difference (Net)|0.0034|STANDARD_ERROR_OF_MEAN|0.055|||TWO_SIDED|95.0|-0.1|0.11|||||A negative value for the estimate would represent a better QOL survey score for the CSTEX arm compared to the SOC-ED arm.|||0.11|-0.1|
70930702|NCT04093869|141360210|SUPERIORITY||Mean Difference (Net)|0.041|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.22|0.3|||||A negative value for the estimate would represent a better Frailty index score for the CSTEX arm compared to the SOC-ED arm.|||0.30|-0.22|
70930703|NCT04093869|141360211|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.2|0.17||||||||0.17|-0.20|
70930704|NCT04093869|141360212|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|95.0|-0.13|0.1||||||||0.10|-0.13|
70930705|NCT04093869|141360213|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.12|0.07||||||||0.07|-0.12|
70930706|NCT04093869|141360214|SUPERIORITY||Mean Difference (Net)|0.39|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-0.83|1.6|||||A positive value for the estimate represents better self-efficacy for the CSTEX arm compared to the SOC-ED arm.|||1.60|-0.83|
70941559|NCT02229396|141383849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|1.06||0.022|TWO_SIDED|95.0|-4.5|-0.4|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-0.4|-4.5|0.022
70941560|NCT05135156|141383854|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.02|TWO_SIDED|95.0|3.0|25.0|||Regression, Linear||Difference = intervention - control|||25|3|0.02
70941561|NCT05135156|141383855|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.15|TWO_SIDED|95.0|-1.0|6.6|||Regression, Linear||Difference = intervention - control|||6.6|-1.0|0.15
71105069|NCT00643279|141717189|SUPERIORITY|Survival estimate at 6-months|6-month survival rate|100.0|||||ONE_SIDED|95.0|98.9||||||||||98.9|
71117600|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
71117601|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
71117602|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
70930707|NCT03816397|141360242|SUPERIORITY|A sample size of 118 subjects (59 in each group) provides 88% power to detect a hazard ratio of 2.0 for the time to treatment failure comparing the group randomized to discontinue adalimumab to the group randomized to continue using adalimumab, assuming a median time until treatment failure of 10 weeks in the group that discontinues adalimumab (Arm 1) and of 20 weeks in the group that continues on adalimumab (Arm 2), an equal allocation between groups, and a 10% total loss to follow-up.|Hazard Ratio (HR)|8.7|||<|0.0001|TWO_SIDED|95.0|3.6|21.2||A priori threshold for statistical significance was \<0.05.|Log Rank||For the HR, the numerator is the placebo group (stop adalimumab) and the denominator is the adalimumab group (continue adalimumab).|A Cox proportional hazards regression was used to compare time to treatment failure between the adalimumab and placebo groups up to the primary endpoint of 48 weeks, with country and conventional DMARD use included as fixed effects in the model. The null hypothesis was an hazard ratio (HR) of 1. Hypothesis testing was based on a permutation test of the log hazard ratio (100,000 replicates). The model was checked for the assumption of proportional hazards by assessing Schoenfeld residuals.||21.2|3.6|<0.0001
70930708|NCT03493542|141360375|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval of GMT ratio (9 to 19 years old/20 to 26 years old) was greater than 0.67 for each HPV type.|GMT Ratio|1.42|||<|0.0001|TWO_SIDED|95.0|1.28|1.58|||ANOVA||GMT Ratio = GMT (9-19 yr)/GMT(20-26 yr)|Anti-HPV 6||1.58|1.28|<0.0001
70930709|NCT03493542|141360375|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval of GMT ratio (9 to 19 years old/20 to 26 years old) was greater than 0.67 for each HPV type.|GMT Ratio|1.39|||<|0.0001|TWO_SIDED|95.0|1.25|1.55|||ANOVA||GMT Ratio = GMT (9-19 yr)/GMT(20-26 yr)|Anti-HPV 11||1.55|1.25|<0.0001
70930710|NCT03493542|141360375|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval of GMT ratio (9 to 19 years old/20 to 26 years old) was greater than 0.67 for each HPV type.|GMT Ratio|1.53|||<|0.0001|TWO_SIDED|95.0|1.37|1.7|||ANOVA||GMT Ratio = GMT (9-19 yr)/GMT(20-26 yr)|Anti-HPV 16||1.70|1.37|<0.0001
70930711|NCT03493542|141360375|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval of GMT ratio (9 to 19 years old/20 to 26 years old) was greater than 0.67 for each HPV type.|GMT Ratio|1.66|||<|0.0001|TWO_SIDED|95.0|1.45|1.9|||ANOVA||GMT Ratio = GMT (9-19 yr)/GMT(20-26 yr)|Anti-HPV 18||1.90|1.45|<0.0001
70930712|NCT03493542|141360396|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval for the difference (9 to 19 years old minus 20 to 26 years old) in seroconversion percentages being greater than -5 percentage points for each HPV type.|Difference in percentages (%)|0.0|||<|0.0001|TWO_SIDED|95.0|-1.1|1.2|||Miettinen & Nurminen method|||Difference of Seroconversion percentage HPV 6||1.2|-1.1|<0.0001
70930713|NCT03493542|141360396|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval for the difference (9 to 19 years old minus 20 to 26 years old) in seroconversion percentages being greater than -5 percentage points for each HPV type.|Difference in percentages (%)|0.0|||<|0.0001|TWO_SIDED|95.0|-1.1|1.2|||Miettinen & Nurminen method|||Difference of Seroconversion percentage HPV 11||1.2|-1.1|<0.0001
70930714|NCT03493542|141360396|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval for the difference (9 to 19 years old minus 20 to 26 years old) in seroconversion percentages being greater than -5 percentage points for each HPV type.|Difference in percentages (%)|0.0|||<|0.0001|TWO_SIDED|95.0|-1.1|1.2|||Miettinen & Nurminen method|||Difference of Seroconversion percentage HPV 16||1.2|-1.1|<0.0001
70930715|NCT03493542|141360396|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval for the difference (9 to 19 years old minus 20 to 26 years old) in seroconversion percentages being greater than -5 percentage points for each HPV type.|Difference in percentages (%)|0.0|||<|0.0001|TWO_SIDED|95.0|-1.1|1.2|||Miettinen & Nurminen method|||Difference of Seroconversion percentage HPV 18||1.2|-1.1|<0.0001
70930716|NCT05485935|141360405|SUPERIORITY||Mean Difference (Final Values)|45.94||||0.001|TWO_SIDED|95.0|19.24|72.64||The pass criteria were based on results analysing the 2 primary endpoints in a hierarchical fashion: rejecting the H0 on the first endpoint (Residual urine at first flow-stop) before continuing to the second (Number of flow-stop episodes).|Mixed Models Analysis|||This was a superiority investigation in which the null hypothesis of the primary endpoints was to be rejected, at a 5% significance (alpha 0.05), to demonstrate the superiority of the investigational device.||72.64|19.24|0.001
70930717|NCT05485935|141360406|SUPERIORITY|The pass criteria were based on the results analysing the two primary endpoints in a hierarchical fashion: rejecting the null hypothesis on the first endpoint (Residual urine at first flow-stop) before continuing to the second (Number of flow-stop episodes).|Risk Ratio (RR)|0.15|||<|0.001|TWO_SIDED|95.0|0.07|0.35|||Mixed Models Analysis|||This was a superiority investigation in which the null hypothesis of the primary endpoints was to be rejected, at a 5% significance (alpha 0.05), to demonstrate the superiority of the investigational device.||0.35|0.07|<0.001
70930718|NCT05485935|141360407|SUPERIORITY|The pass criteria were based on the results analysing the two primary endpoints in a hierarchical fashion: rejecting the null hypothesis on the first endpoint (Residual urine at first flow-stop) before continuing to the second (Number of flow-stop episodes).|Risk Ratio (RR)|0.13|||<|0.001|TWO_SIDED|95.0|0.04|0.4|||Mixed Models Analysis|||This was a superiority investigation in which the null hypothesis of the primary endpoints was to be rejected, at a 5% significance (alpha 0.05), to demonstrate the superiority of the investigational device.||0.40|0.04|<0.001
70941562|NCT05135156|141383856|SUPERIORITY||Mean Difference (Net)|-1.2||||0.81|TWO_SIDED|95.0|-10.9|8.5|||Regression, Linear||Estimation parameter is regression parameter comparing intervention to control|||8.5|-10.9|0.81
70850813|NCT04248491|141189620|SUPERIORITY|||||||0.472|||||||t-test, 2 sided|||||||0.472
71016912|NCT03692078|141541626|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (PP Population)|Mean Difference (Net)|3.437|||<|0.0001|TWO_SIDED|95.0|3.306|3.568|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (PP Population)||3.568|3.306|<.0001
71016913|NCT03692078|141541626|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (PP Population)|Mean Difference (Net)|-0.461|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.262|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (PP Population)||-0.262|-0.660|<.0001
71016914|NCT03692078|141541626|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (PP Population)|Mean Difference (Net)|-0.462|||<|0.0001|TWO_SIDED|95.0|-0.679|-0.244|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (PP Population)||-0.244|-0.679|<.0001
71016915|NCT03692078|141541626|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (PP Population)|Mean Difference (Net)|-0.433|||<|0.0001|TWO_SIDED|95.0|-0.633|-0.233|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (PP Population)||-0.233|-0.633|<.0001
71016916|NCT03692078|141541626|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (PP Population)|Mean Difference (Net)|-0.461|||<|0.0001|TWO_SIDED|95.0|-0.678|-0.244|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (PP Population)||-0.244|-0.678|<.0001
71016917|NCT03692078|141541626|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (PP Population)|Mean Difference (Net)|-1.928|||<|0.0001|TWO_SIDED|95.0|-2.154|-1.701|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (PP Population)||-1.701|-2.154|<.0001
71016918|NCT03692078|141541626|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (PP Population)|Mean Difference (Net)|-2.089|||<|0.0001|TWO_SIDED|95.0|-2.336|-1.842|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (PP Population)||-1.842|-2.336|<.0001
71016919|NCT03692078|141541626|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (PP Population)|Mean Difference (Net)|-1.879|||<|0.0001|TWO_SIDED|95.0|-2.102|-1.656|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (PP Population)||-1.656|-2.102|<.0001
70850814|NCT04248491|141189622|SUPERIORITY|||||||0.342|||||||t-test, 2 sided|||||||0.342
70850815|NCT03328208|141189715|SUPERIORITY||Mean Difference (Final Values)|0.724|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70850816|NCT03328208|141189716|SUPERIORITY||Mean Difference (Final Values)|0.038|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70850817|NCT06026124|141189738|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
70850818|NCT06026124|141189738|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
70850819|NCT06026124|141189739|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
70850820|NCT06026124|141189739|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
70850821|NCT06026124|141189740|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
70850822|NCT06026124|141189740|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
70850823|NCT06026124|141189741|SUPERIORITY||||||<|0.0001|||||||LSD test|||||||<0.0001
70850824|NCT06026124|141189741|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
70930719|NCT05485935|141360408|SUPERIORITY|The pass criteria were based on the results analysing the two primary endpoints in a hierarchical fashion: rejecting the null hypothesis on the first endpoint (Residual urine at first flow-stop) before continuing to the second (Number of flow-stop episodes).|Mean Difference (Final Values)|28.5||||0.004|TWO_SIDED|95.0|9.5|47.6|||Mixed Models Analysis|||This was a superiority investigation in which the null hypothesis of the primary endpoints was to be rejected, at a 5% significance (alpha 0.05), to demonstrate the superiority of the investigational device.||47.6|9.5|0.004
70930720|NCT03839446|141360418|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.777|TWO_SIDED|95.0|0.18|3.65|||Regression, Cox||Intermediate / Favorable vs Poor|Cytogenetic status||3.65|0.18|0.777
70930721|NCT03839446|141360418|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.2|TWO_SIDED|95.0|0.96|1.01|||Regression, Cox|||Percent of blasts present in the bone marrow.||1.01|0.96|0.200
70930722|NCT03839446|141360418|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.014|TWO_SIDED|95.0|0.94|0.99|||Regression, Cox|||% CD33 expression in leukemia blasts||0.99|0.94|0.014
70930723|NCT03839446|141360419|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.801|TWO_SIDED|95.0|0.17|3.86|||Regression, Cox||Intermediate / Favorable vs Poor|Cytogenetic status||3.86|0.17|0.801
70930724|NCT03839446|141360419|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.168|TWO_SIDED|95.0|0.95|1.01|||Regression, Cox|||% bone marrow blasts||1.01|0.95|0.168
70930725|NCT03839446|141360419|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.015|TWO_SIDED|95.0|0.94|0.99|||Regression, Cox|||% CD33 expression in leukemia blasts||0.99|0.94|0.015
70930726|NCT01527188|141360427|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-198.18||||0.0427|TWO_SIDED|95.0|-389.82|-6.55|||ANCOVA|||||-6.55|-389.82|0.0427
70930727|NCT01527188|141360427|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-171.82||||0.0793||95.0|-363.87|20.24|||ANCOVA|||||20.24|-363.87|0.0793
70930728|NCT01527188|141360427|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-118.43|||||TWO_SIDED|95.0|-305.9|69.04|||ANCOVA|||The statistical test is not applicable due to the step-down approach performed to address the multiplicity issue.||69.04|-305.90|
70930729|NCT01527188|141360428|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-125.61||||0.0323||95.0|-240.53|-10.69|||ANCOVA|||||-10.69|-240.53|0.0323
70930730|NCT01527188|141360428|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-122.23||||0.0376||95.0|-237.38|-7.08|||ANCOVA|||||-7.08|-237.38|0.0376
70930731|NCT01527188|141360428|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-91.18||||0.1119||95.0|-203.74|21.38|||ANCOVA|||||21.38|-203.74|0.1119
70930732|NCT03512301|141360447|OTHER||Accuracy|0.6587|||||TWO_SIDED|95.0|0.569|0.7408||||||||0.7408|0.5690|
70930733|NCT03512301|141360447|OTHER||Sensitivity|0.8736|||||TWO_SIDED|||||||||||||
70930734|NCT03512301|141360447|OTHER||Specificity|0.4872|||||TWO_SIDED|||||||||||||
70930735|NCT03512301|141360447|OTHER||Positive Predictive Value|0.7917|||||TWO_SIDED|||||||||||||
70930736|NCT03512301|141360447|OTHER||Negative Predictive Value|0.6333|||||TWO_SIDED|||||||||||||
70930737|NCT03512301|141360447|OTHER||Sensitivity|0.1212|||||TWO_SIDED|||||||||||||
70930738|NCT03512301|141360447|OTHER||Specificity|0.9032|||||TWO_SIDED|||||||||||||
70930739|NCT03512301|141360447|OTHER||Positive Predictive Value|0.3077|||||TWO_SIDED|||||||||||||
70930740|NCT03512301|141360447|OTHER||Negative Predictive Value|0.7434|||||TWO_SIDED|||||||||||||
70930741|NCT03512301|141360447|OTHER||Sensitivity|0.5|||||TWO_SIDED|||||||||||||
70930742|NCT03512301|141360447|OTHER||Specificity|0.8833|||||TWO_SIDED|||||||||||||
70930743|NCT03512301|141360447|OTHER||Positive Predictive Value|0.1765|||||TWO_SIDED|||||||||||||
70930744|NCT03512301|141360447|OTHER||Negative Predictive Value|0.9725|||||TWO_SIDED|||||||||||||
70930745|NCT03512301|141360447|OTHER||Quadratic Weighted Kappa|0.4446|||||TWO_SIDED|95.0|0.2791|0.6101||||||||0.6101|0.2791|
70930746|NCT03512301|141360448|OTHER|Linear Regression. Power calculations for linear regression between CAMCI and MoCA were found to be sufficiently powered with a Pearson's R of at least 0.3 at 80% power and that equated to a test-set size of 98.|Pearson Correlation|0.5073|||||TWO_SIDED|95.0|0.3892|0.6091|||||Linear Regression Equation: \[CAMCI Score\] = -5.42 + 1.40 X \[MoCA Score\]|||0.6091|0.3892|
70930747|NCT03512301|141360448|OTHER||Accuracy|0.5556|||||TWO_SIDED|95.0|0.4644|0.644||||||||0.6440|0.4644|
70930748|NCT03512301|141360448|OTHER||Sensitivity|0.9747|||||TWO_SIDED|||||||||||||
70930749|NCT03512301|141360448|OTHER||Specificity|0.3913|||||TWO_SIDED|||||||||||||
70930750|NCT03512301|141360448|OTHER||Positive Predictive Value|0.5625|||||TWO_SIDED|||||||||||||
70930751|NCT03512301|141360448|OTHER||Negative Predictive Value|0.9|||||TWO_SIDED|||||||||||||
70930752|NCT03512301|141360448|OTHER||Sensitivity|0.1905|||||TWO_SIDED|||||||||||||
70930753|NCT03512301|141360448|OTHER||Specificity|0.9841|||||TWO_SIDED|||||||||||||
70930754|NCT03512301|141360448|OTHER||Positive Predictive Value|0.9231|||||TWO_SIDED|||||||||||||
70930755|NCT03512301|141360448|OTHER||Negative Predictive Value|0.5487|||||TWO_SIDED|||||||||||||
70930756|NCT03512301|141360448|OTHER||Sensitivity|0.6667|||||TWO_SIDED|||||||||||||
70930757|NCT03512301|141360448|OTHER||Specificity|0.8917|||||TWO_SIDED|||||||||||||
70930758|NCT03512301|141360448|OTHER||Positive Predictive Value|0.2353|||||TWO_SIDED|||||||||||||
70930759|NCT03512301|141360448|OTHER||Negative Predictive Value|0.9817|||||TWO_SIDED|||||||||||||
70930760|NCT03512301|141360448|OTHER||Quadratic Weighted Kappa|0.3931|||||TWO_SIDED|95.0|0.2401|0.5461||||||||0.5461|0.2401|
70930761|NCT03952520|141360453|SUPERIORITY||Mean Difference (Final Values)|37.3|||||TWO_SIDED|95.0|26.5|48.1|||||This generalized linear model was adjusted for engagement of site leadership. The Standard Approach is the referent.|||48.1|26.5|
70930762|NCT03952520|141360454|SUPERIORITY||Risk Difference (RD)|2.0|||||TWO_SIDED|95.0|2.0|2.1|||||This generalized linear model was adjusted for engagement of site leadership and used generalized estimating equations to account for clustering by HIV test site. The Standard Approach is the referent.|||2.1|2.0|
70930763|NCT03952520|141360456|SUPERIORITY||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.2|0.4|||||This generalized linear model was adjusted for engagement of site leadership and used generalized estimating equations to account for clustering by HIV test site. The Standard Approach is the referent.|||0.4|-0.2|
70930764|NCT03952520|141360457|SUPERIORITY||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-3.1|2.0|||||This generalized linear model was adjusted for engagement of site leadership and used generalized estimating equations to account for clustering by HIV test site. The Standard Approach is the referent.|||2.0|-3.1|
70930765|NCT03952520|141360458|SUPERIORITY||Prevalence Difference|15.8|||||TWO_SIDED|95.0|5.0|26.5|||||This generalized linear model was adjusted for engagement of site leadership and used generalized estimating equations to account for clustering by HIV test site. The Standard Approach is the referent.|||26.5|5.0|
70930766|NCT03952520|141360459|SUPERIORITY||Prevalence Difference|1.6|||||TWO_SIDED|95.0|-6.9|10.0|||||This generalized linear model was adjusted for engagement of site leadership and used generalized estimating equations to account for clustering by HIV test site. The Standard Approach is the referent.|||10.0|-6.9|
70930767|NCT03952520|141360461|SUPERIORITY||Prevalence Difference|6.2|||||TWO_SIDED|95.0|-1.5|13.8|||||This generalized linear model was adjusted for engagement of site leadership and used generalized estimating equations to account for clustering by HIV test site. The Standard Approach is the referent.|||13.8|-1.5|
70930768|NCT03635567|141360463|OTHER||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.47|0.71||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (hazard ratio \[HR\]) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.71|0.47|<0.0001
70930769|NCT03635567|141360464|OTHER||Hazard Ratio (HR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.5|0.74||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (HR) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.74|0.50|<0.0001
70930770|NCT03635567|141360465|OTHER||Hazard Ratio (HR)|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.68||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (HR) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.68|0.40|<0.0001
70930771|NCT03635567|141360466|OTHER||Hazard Ratio (HR)|0.6|||<|0.0001|TWO_SIDED|95.0|0.49|0.74||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (HR) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.74|0.49|<0.0001
70930772|NCT03635567|141360467|OTHER||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.52|0.77||No formal hypothesis testing performed; nominal p-value based on log-rank test provided for treatment comparison.|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (HR) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.77|0.52|<0.0001
70930773|NCT03635567|141360468|OTHER||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.44|0.78||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (HR) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.78|0.44|<0.0001
70930774|NCT03635567|141360469|OTHER||Difference in Percentage|14.9||||0.0001|TWO_SIDED|95.0|7.4|22.3||No formal hypothesis testing performed; nominal p-value provided for treatment comparison|Miettinen & Nurminen method|||Treatment comparison was based on Miettinen \& Nurminen method stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||22.3|7.4|0.0001
70930775|NCT03635567|141360472|OTHER||Hazard Ratio (HR)|0.6|||<|0.0001|TWO_SIDED|95.0|0.49|0.74||No formal hypothesis testing performed; nominal p-value provided for treatment comparison|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (HR) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.74|0.49|<0.0001
70930776|NCT05157841|141360478|SUPERIORITY|A one-sided hypothesis test was performed at alpha=0.025 level of significance comparing EXPAREL and bupivacaine HCI|Mean Difference (Final Values)|-164.0|STANDARD_ERROR_OF_MEAN|27.74|<|1e-05|TWO_SIDED|95.0|-218.3|-109.6|||ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||The superiority of EXPAREL to bupivacaine hydrochloric acid (HCI) was evaluated using the Efficacy Analysis Set.||-109.6|-218.3|<0.00001
70930777|NCT05157841|141360479|SUPERIORITY|A one-sided hypothesis test was performed at alpha=0.025 level of significance comparing EXPAREL and bupivacaine HCI|Least square mean difference|0.39|||<|1e-05|TWO_SIDED|95.0|0.28|0.55|||ANCOVA|||The superiority of EXPAREL to bupivacaine hydrochloric acid (HCI) was evaluated using the Efficacy Analysis Set.||0.55|0.28|<0.00001
70930778|NCT05157841|141360480|SUPERIORITY||Odds Ratio (OR)|5.04||||0.0003|TWO_SIDED|95.0|2.01|12.62|||ANCOVA|||||12.62|2.01|0.0003
70930779|NCT05157841|141360481|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0089|TWO_SIDED|95.0|0.45|0.93|||Cox proportional hazards model|Cox proportional hazards model with treatment as main effect and site as categorical and age as continuous covariates.||||0.93|0.45|0.0089
70930780|NCT05157841|141360482|SUPERIORITY||Least square mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.44||0.0296|TWO_SIDED|95.0|-1.7|0.0||Worst pain 0-24 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariate of age.||||0.0|-1.7|0.0296
70850825|NCT06026124|141189742|SUPERIORITY||||||=|0.17|||||||LSD test|||||||=0.17
70850826|NCT06026124|141189742|SUPERIORITY||||||=|1|||||||LSD test|||||||=1.00
70850827|NCT06026124|141189743|SUPERIORITY||||||<|0.0001|||||||LSD test|||||||<0.0001
71016920|NCT03692078|141541626|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (PP Population)|Mean Difference (Net)|-2.017|||<|0.0001|TWO_SIDED|95.0|-2.262|-1.772|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (PP Population)||-1.772|-2.262|<.0001
71016921|NCT03692078|141541626|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (PP Population)|Mean Difference (Net)|1.465|||<|0.0001|TWO_SIDED|95.0|1.25|1.679|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (PP Population)||1.679|1.250|<.0001
71016922|NCT03692078|141541626|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (PP Population)|Mean Difference (Net)|1.537|||<|0.0001|TWO_SIDED|95.0|1.303|1.772|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (PP Population)||1.772|1.303|<.0001
71016923|NCT03692078|141541626|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (PP Population)|Mean Difference (Net)|1.492|||<|0.0001|TWO_SIDED|95.0|1.277|1.707|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (PP Population)||1.707|1.277|<.0001
71016924|NCT03692078|141541626|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (PP Population)|Mean Difference (Net)|1.538|||<|0.0001|TWO_SIDED|95.0|1.304|1.772|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (PP Population)||1.772|1.304|<.0001
71016925|NCT03692078|141541626|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (PP Population)|Mean Difference (Net)|-0.003||||1|TWO_SIDED|95.0|-0.242|0.237|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (PP Population)||0.237|-0.242|1.0000
70850828|NCT06026124|141189744|SUPERIORITY||||||=|0.51|||||||LSD test|||||||=0.51
70850829|NCT03023813|141189748|OTHER|||||||0.5|||||||t-test, 2 sided|||||||0.50
70850830|NCT03023813|141189749|OTHER|||||||0.25|||||||t-test, 2 sided|||||||.25
70850831|NCT03023813|141189750|OTHER|||||||0.39|||||||t-test, 2 sided|||||||.39
70850832|NCT03023813|141189751|OTHER|||||||0.59|||||||t-test, 2 sided|||||||0.59
70850833|NCT03023813|141189752|OTHER|||||||0.53|||||||t-test, 2 sided|||||||0.53
70850834|NCT03023813|141189753|OTHER|||||||0.91|||||||t-test, 2 sided|||||||0.91
70850835|NCT03023813|141189754|OTHER|Percent change in weight (lbs.) since the baseline encounter|Mean Difference (Net)|-2.96||||0.27|TWO_SIDED|95.0|-8.18|2.26|||Mixed Models Analysis||Result for intervention arm minus control arm|Among participants whose individualized preventive care recommendations included weight loss||2.26|-8.18|0.27
70850836|NCT03023813|141189754|OTHER|Change in systolic blood pressure since the baseline encounter (mmHg)|Mean Difference (Net)|-6.42||||0.19|TWO_SIDED|95.0|-16.12|3.27|||Mixed Models Analysis||Result for intervention arm minus control arm|Among participants whose individualized preventive care recommendations included blood pressure control||3.27|-16.12|0.19
70850837|NCT03023813|141189754|OTHER|Percentage point change in HbA1c (%) since the baseline encounter|Mean Difference (Net)|-0.68||||0.24|TWO_SIDED|95.0|-1.82|0.45|||Mixed Models Analysis||Result for intervention arm minus control arm|Among participants whose individualized preventive care recommendations included glycemic control||0.45|-1.82|0.24
70850838|NCT03023813|141189754|OTHER|Percentage point change in 10-year atherosclerotic cardiovascular disease risk (%), as estimated by the American College of Cardiology Pooled Cohort Equations, since the baseline encounter|Mean Difference (Net)|-1.2||||0.34|TWO_SIDED|95.0|-3.65|1.26|||Generalized linear mixed regression||Result for intervention arm minus control arm|Among participants whose individualized preventive care recommendations included lipids control||1.26|-3.65|0.34
70930781|NCT05157841|141360482|SUPERIORITY||Least square mean difference|-2.9|STANDARD_ERROR_OF_MEAN|0.4|<|1e-05|TWO_SIDED|95.0|-3.6|-2.1||Worst pain 24-48 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-2.1|-3.6|<0.00001
70930782|NCT05157841|141360482|SUPERIORITY||Least square mean difference|-3.3|STANDARD_ERROR_OF_MEAN|0.41|<|1e-05|TWO_SIDED|95.0|-4.1|-2.5||Worst pain 48-72 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-2.5|-4.1|<0.00001
70930783|NCT05157841|141360482|SUPERIORITY||Least square mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.43|<|1e-05|TWO_SIDED|95.0|-3.0|-1.3||Worst pain 72-96 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-1.3|-3.0|<0.00001
70930784|NCT05157841|141360482|SUPERIORITY||Least square mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.36||0.3419|TWO_SIDED|95.0|-0.9|0.6||Average pain 0-24 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.6|-0.9|0.3419
70930785|NCT05157841|141360482|SUPERIORITY||Least square mean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.31|<|1e-05|TWO_SIDED|95.0|-2.5|-1.3||Average pain 24-48 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-1.3|-2.5|<0.00001
70930786|NCT05157841|141360482|SUPERIORITY||Least square mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.31|<|1e-05|TWO_SIDED|95.0|-2.8|-1.6||Average pain 48-72 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-1.6|-2.8|<0.00001
70850839|NCT03023813|141189754|OTHER|Change in low-density lipoprotein (LDL) cholesterol (mg/dL) since the baseline encounter|Mean Difference (Net)|-8.46||||0.36|TWO_SIDED|95.0|-26.63|9.7|||Mixed Models Analysis||Result for intervention arm minus control arm|Among participants whose individualized preventive care recommendations included lipids control||9.70|-26.63|0.36
70930787|NCT05157841|141360482|SUPERIORITY||Least square mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.31|<|1e-05|TWO_SIDED|95.0|-2.1|-0.9||Average pain 72-96 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-0.9|-2.1|<0.00001
70930788|NCT04933474|141360490|OTHER|||||||0.088|||||||Chi-squared|||The primary outcome will be the baseline vs. week 8 difference-in-difference in 7-day average NRS pain intensity scores, dichotomized into if the MCID of 2 is achieved. The between arm difference of achieving the MCID of 2 will be tested using Chi-squared test.||||0.088
70930789|NCT04933474|141360491|OTHER|||||||0.103|||||||t-test, 2 sided|||A two-sample t-test will be used to compare differences-in-differences between the arms.||||0.103
70930790|NCT04933474|141360492|OTHER|||||||0.774|||||||t-test, 2 sided|||A two-sample t-test will be used to compare differences-in-differences between the arms.||||0.774
70930791|NCT04933474|141360493|OTHER|||||||0.005|||||||t-test, 2 sided|||A two-sample t-test will be used to compare differences-in-differences between the arms.||||0.005
70930792|NCT04933474|141360494|OTHER|||||||0.831|||||||t-test, 2 sided|||A two-sample t-test will be used to compare differences-in-differences between the arms.||||0.831
70930793|NCT04933474|141360495|OTHER||Common Odds Ratio|1.44||||0.031|TWO_SIDED|95.0|1.03|2.02||A two-sided test performed at the 0.05 level of significance without the continuity correction.|Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel (CMH) test was used to compare the association between time (baseline and week 8) and opioid use (yes or no) while stratifying for the treatment groups. The null hypothesis is that the common odds ratio of the association between time and response across the treatment groups is equal to 1, versus the alternative hypothesis that the common odds ratio is not equal to 1.||2.02|1.03|0.031
70850840|NCT03023813|141189754|OTHER|Change in smoking intensity (defined as a change in smoking status from Current Every Day to either Current Some Days or Quit; or from Current Some Days to Quit) since the baseline encounter.|Odds Ratio (OR)|1.2||||0.92|TWO_SIDED|95.0|0.03|45.56|||Mixed Models Analysis|Generalized linear mixed regression with logit link|Result for intervention arm relative to control arm. OR \<1 indicates reduction in smoking intensity; OR \>1 indicates increase in smoking intensity.|Among participants whose individualized preventive care recommendations included tobacco cessation||45.56|0.03|0.92
70930794|NCT04174170|141360496|SUPERIORITY||Treatment Difference|1.03||||0.5165|TWO_SIDED|95.0|-2.09|4.16|||MMRM|||||4.16|-2.09|0.5165
70930795|NCT04174170|141360496|SUPERIORITY||Treatment Difference|-0.71||||0.6593|TWO_SIDED|95.0|-3.88|2.46|||MMRM|||||2.46|-3.88|0.6593
70930796|NCT04174170|141360497|SUPERIORITY||Treatment Difference|0.03||||0.8215|TWO_SIDED|95.0|-0.25|0.31||MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|MMRM|||||0.31|-0.25|0.8215
70930797|NCT04174170|141360497|SUPERIORITY||Treatment Difference|-0.03||||0.8584|TWO_SIDED|95.0|-0.31|0.26||MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|MMRM|||||0.26|-0.31|0.8584
70930798|NCT04174170|141360498|SUPERIORITY||Treatment Difference|-4.16||||0.2331|TWO_SIDED|95.0|-11.0|2.69||MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|MMRM|||||2.69|-11.00|0.2331
70930799|NCT04174170|141360498|SUPERIORITY||Treatment Difference|-8.83||||0.0134|TWO_SIDED|95.0|-15.82|-1.85||MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|MMRM|||||-1.85|-15.82|0.0134
70930800|NCT04586244|141360609|SUPERIORITY|||||||0.0925|||||||paired t-test|The paired t-test used n-1 degrees of freedom, where n is the number of evaluable paired samples.||||||0.0925
70930801|NCT00709956|141360648|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|-1.5||||0.7883|TWO_SIDED|95.0|-12.3|9.4||If the primary endpoint reaches significance, treatment effect of the secondary endpoint is determined at a 2-sided nominal of 0.05. Since hierarchy of the endpoints to be tested has been predefined, no correction for multiple testing will be applied|Generalized linear model|Subject (sequence), treatment, and period as fixed effect||With a sample size of at least 63 patients and based on the assumptions on the primary endpoint (normal distribution, SD of the difference of 30 m) the study was designed to detect a significant treatment effect with 90% power, assuming a difference exceeding 12.5 m between the mean values of the 6MWD following the iloprost power 15 treatment and the one following the placebo treatment.||9.4|-12.3|0.7883
70930802|NCT01992913|141360837|SUPERIORITY||||||<|0.05||||||"Fisher's exact Test, right-sided probability based on a directional hypothesis."|Fisher Exact|||We conducted a 2 X 2 chi-square analysis of differences in proportion.||||<.05
71016926|NCT03692078|141541626|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (PP Population)|Mean Difference (Net)|-0.09||||0.9399|TWO_SIDED|95.0|-0.351|0.172|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (PP Population)||0.172|-0.351|0.9399
71016927|NCT03692078|141541626|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (PP Population)|Mean Difference (Net)|0.047||||0.9993|TWO_SIDED|95.0|-0.19|0.283|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (PP Population)||0.283|-0.190|0.9993
71016928|NCT03692078|141541626|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (PP Population)|Mean Difference (Net)|-0.018||||1|TWO_SIDED|95.0|-0.278|0.242|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (PP Population)||0.242|-0.278|1.0000
71016929|NCT03692078|141541628|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.805|||<|0.0001|TWO_SIDED|95.0|1.639|1.971|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||1.971|1.639|<.0001
71016930|NCT03692078|141541628|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.788|||<|0.0001|TWO_SIDED|95.0|1.622|1.954|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||1.954|1.622|<.0001
71016931|NCT03692078|141541628|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.29|||<|0.0001|TWO_SIDED|95.0|1.145|1.462|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||1.462|1.145|<.0001
70930803|NCT01992913|141360837|SUPERIORITY||Odds Ratio (OR)|2.65|||<|0.06|TWO_SIDED|95.0|0.97|7.13|||Chi-squared|ChiSq = 3.6562, df = 1|OR, iCBT / TAU in job attainment|Chis Sq: group (iCBT/TAU) X Job attained (Yes/No)||7.13|0.97|<.06
70930804|NCT01992913|141360838|SUPERIORITY|A mixed effects logistic regression model was conducted on a binary work variable, with a random intercept, using the baseline measure as a binary covariate.|Odds Ratio, log|-0.9|STANDARD_ERROR_OF_MEAN|0.91|<|0.33|TWO_SIDED|95.0|-2.67|0.89|||Mixed Models Analysis|df (1, 30) for the group X assessment interaction, adjusting for baseline differences in hours worked at the start of the intervention.||Compare the groups on proportions in employment at the 6 month assessment points.||.89|-2.67|<0.33
70930805|NCT01992913|141360838|SUPERIORITY|A mixed effects logistic regression model was conducted on a binary work variable, with a random intercept, using the baseline measure as a binary covariate.|Odds Ratio, log|0.52|STANDARD_ERROR_OF_MEAN|0.85|<|0.54|TWO_SIDED|95.0|-1.14|2.19|||Mixed Models Analysis|F (1, 130) = 1.0, p\<0.37, for the group X assessment interaction, adjusting for baseline differences in hours worked at the start of the intervention.||Compare the groups on proportions in employment at the 12 month assessment points.||2.19|-1.14|<.54
70930806|NCT01992913|141360838|SUPERIORITY|A mixed effects logistic regression model was conducted on a binary work variable, with a random intercept, using the baseline measure as a binary covariate.|Odds Ratio, log|0.31|STANDARD_ERROR_OF_MEAN|0.83|<|0.71|TWO_SIDED|95.0|-1.32|1.73|||Mixed Models Analysis|F (1, 130) = 1.0, p\<0.37, for the group X assessment interaction, adjusting for baseline differences in hours worked at the start of the intervention.||Compare the groups on proportions in employment at the 18 month assessment point.||1.73|-1.32|<0.71
70941563|NCT05135156|141383857|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.15|TWO_SIDED|95.0|-0.1|0.8|||Regression, Linear||Difference = intervention - control|||0.8|-0.1|0.15
71016932|NCT03692078|141541628|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.304|||<|0.0001|TWO_SIDED|95.0|1.134|1.447|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||1.447|1.134|<.0001
71105070|NCT05715827|141717197|OTHER|The study used descriptive statistics and 95% confidence intervals to summarize data. The sample size of 40 patients (20 per surgery type) was based on prior studies with 3% device malfunction and 0.9% failure-related conversion rates. The primary endpoint was the completion rate, defined as ≥95% without conversion due to system issues or major complications within 24 hours. The Full Analysis Set included all subjects who started the procedure. No interim analyses were planned.|Completion rate|97.5|||||TWO_SIDED|95.0|86.8|99.9||The study used descriptive statistics and confidence intervals, not hypothesis testing with p-values. The main goal was to confirm the completion rate met or exceeded 95% and present a 95% confidence interval||The main goal was to confirm the completion rate met or exceeded 95% with a 95% confidence interval.|Estimated Value of 97.5% is an overall completion rate|The study aimed to confirm the Medtronic Hugo™ RAS System's performance for prostatectomy or cholecystectomy, targeting a 95% completion rate (no conversion due to system issues or major complications within 24 hours). The Full Analysis Set (FAS) included all subjects starting the procedure. Descriptive statistics and 95% confidence intervals were used to assess primary and secondary endpoints, confirming safety and effectiveness.|Descriptive Analysis was used|99.9|86.8|
71105071|NCT05715827|141717198|OTHER|Descriptive statistics will be used, presenting frequency, percentage, and 95% confidence intervals for each secondary endpoint: overall complication rate, major complication rate, readmission rate, reoperation rate, and Device Deficiencies (DD) rate through 30 days post-surgery. Secondary endpoints will be assessed overall and by surgery type (prostatectomy and cholecystectomy).|Overall Complication Rate|20.0|||||TWO_SIDED|95.0|9.1|35.6||Descriptive statistics and estimated rates were used. P-values were not calculated for secondary endpoints.||||The secondary objective is to assess the short-term safety outcome of the Medtronic Hugo™ RAS System when used for prostatectomy or cholecystectomy. Overall complication rate through 30-day post-surgery: A proportion of subjects with any postoperative complication within 30-days post-surgery using the investigational device||35.6|9.1|
71105072|NCT05715827|141717199|OTHER|Descriptive statistics will be used, presenting frequency, percentage, and 95% confidence intervals for each secondary endpoint: overall complication rate, major complication rate, readmission rate, reoperation rate, and Device Deficiencies (DD) rate through 30 days post-surgery. Secondary endpoints will be assessed overall and by surgery type (prostatectomy and cholecystectomy).|Major complication rate|5.0|||||TWO_SIDED|95.0|0.6|16.9||Descriptive statistics and estimated rates were used. P-values were not calculated for secondary endpoints.||||The secondary objective is to assess the short-term safety outcome of the Medtronic Hugo™ RAS System when used for prostatectomy or cholecystectomy. Overall complication rate through 30-day post-surgery: A proportion of subjects with any postoperative complication within 30-days post-surgery using the investigational device||16.9|0.6|
71105073|NCT05715827|141717200|OTHER|Descriptive statistics will be used, presenting frequency, percentage, and 95% confidence intervals for each secondary endpoint: overall complication rate, major complication rate, readmission rate, reoperation rate, and Device Deficiencies (DD) rate through 30 days post-surgery. Secondary endpoints will be assessed overall and by surgery type (prostatectomy and cholecystectomy).|Readmission rate|10.0|||||TWO_SIDED|95.0|2.8|23.7||Descriptive statistics and estimated rates were used. P-values were not calculated for secondary endpoints.||||The secondary objective is to assess the short-term safety outcome of the Medtronic Hugo™ RAS System when used for prostatectomy or cholecystectomy. Overall complication rate through 30-day post-surgery: A proportion of subjects with any postoperative complication within 30-days post-surgery using the investigational device||23.7|2.8|
71117603|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
70930807|NCT01992913|141360840|SUPERIORITY|This is mixed model analysis of the group X assessment interaction. This analysis is the test of mean differences in level of functioning at the baseline assessment.|Mean Difference (Final Values)|-5.03|STANDARD_ERROR_OF_MEAN|3.82|<|0.19|TWO_SIDED||||||Fisher Exact|df (1, 114)||||||<0.19
70930808|NCT01992913|141360840|SUPERIORITY|This is mixed model analysis of the group X assessment interaction. This analysis is the test of mean differences in level of functioning at the 6 month assessment.|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|4.42|<|0.99|TWO_SIDED||||||Fisher Exact|df (1, 114)||||||<0.99
70930809|NCT01992913|141360840|SUPERIORITY|This is mixed model analysis of the group X assessment interaction. This analysis is the test of mean differences in level of functioning at the 12 month assessment.|Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|4.54|<|0.94|TWO_SIDED||||||Fisher Exact|df (1, 114)||||||<0.94
70930810|NCT01992913|141360840|SUPERIORITY|This is mixed model analysis of the group X assessment interaction. This analysis is the test of mean differences in level of functioning at the baseline assessment.|Mean Difference (Final Values)|-6.67|STANDARD_ERROR_OF_MEAN|4.52|<|0.14|TWO_SIDED||||||Fisher Exact|df (1, 114)||||||<0.14
70930811|NCT01499368|141360857|NON_INFERIORITY|Non-inferiority: The Lower limit is not lower than -15%||||||0.05|||||||Chi-squared|||||||0.05
70930812|NCT01499368|141360858|NON_INFERIORITY|Non-Inferiority||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test||||||0.05
70930813|NCT04227899|141360914|OTHER||||||<|0.0001|||||||One-sided Chi-square test|||||||<0.0001
70930814|NCT04227899|141360915|OTHER|||||||0.0019|||||||Farrington-Manning non-inferiority (NI)|||||||0.0019
70930815|NCT04227899|141360916|OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
70930816|NCT04227899|141360917|OTHER|||||||0.0081|||||||One-sided Chi-square test|||||||0.0081
70930817|NCT00357682|141360930|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.24||||0.068|TWO_SIDED|95.0|0.98|1.57|||Accelerated Failure Time|||Accelerated Failure Time (AFT) analysis comparing time to primary event in low dose PPI (20mg) patients to high dose PPI (80mg) patients. Included in AFT model are stratification factors (Barrett's length, age group and presence of baseline intestinal metaplasia) and aspirin randomisation group.||1.57|0.98|0.068
70930818|NCT00357682|141360930|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.27||||0.037|TWO_SIDED|95.0|1.01|1.58|||Accelerated Failure Time|||Accelerated Failure Time (AFT) analysis comparing time to primary event in aspirin patients to non-aspirin patients. Included in AFT model are stratification factors (Barrett's length, age group and presence of baseline intestinal metaplasia) and PPI randomisation group.||1.58|1.01|0.037
70930819|NCT00357682|141360931|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.36||||0.039|TWO_SIDED|95.0|1.01|1.82|||Accelerated Failure Time|||All recordings of death, regardless of the cause are used in this analysis and both PPI groups are compared.||1.82|1.01|0.039
70930820|NCT00357682|141360931|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.25||||0.159|TWO_SIDED|95.0|0.92|1.7|||Accelerated Failure Time|||There are 163 deaths in the aspirin comparison with all-cause mortality as the endpoint. Median follow-up is 8.9 years IQR: (8.2 , 10.0) Range: (0 , 11.5)||1.70|0.92|0.159
71105074|NCT05715827|141717201|OTHER|Descriptive statistics will be used, presenting frequency, percentage, and 95% confidence intervals for each secondary endpoint: overall complication rate, major complication rate, readmission rate, reoperation rate, and Device Deficiencies (DD) rate through 30 days post-surgery. Secondary endpoints will be assessed overall and by surgery type (prostatectomy and cholecystectomy).|Reoperation rate|0.0|||||TWO_SIDED|||||Descriptive statistics and estimated rates were used. P-values were not calculated for secondary endpoints.||||The secondary objective is to assess the short-term safety outcome of the Medtronic Hugo™ RAS System when used for prostatectomy or cholecystectomy. Overall complication rate through 30-day post-surgery: A proportion of subjects with any postoperative complication within 30-days post-surgery using the investigational device||||
71105075|NCT05715827|141717202|OTHER|Descriptive statistics will be used, presenting frequency, percentage, and 95% confidence intervals for each secondary endpoint: overall complication rate, major complication rate, readmission rate, reoperation rate, and Device Deficiencies (DD) rate through 30 days post-surgery. Secondary endpoints will be assessed overall and by surgery type (prostatectomy and cholecystectomy).|Device deficiency rate|32.5|||||TWO_SIDED|95.0|18.6|49.1||Descriptive statistics and estimated rates were used. P-values were not calculated for secondary endpoints.||||The secondary objective is to assess the short-term safety outcome of the Medtronic Hugo™ RAS System when used for prostatectomy or cholecystectomy. Overall complication rate through 30-day post-surgery: A proportion of subjects with any postoperative complication within 30-days post-surgery using the investigational device||49.1|18.6|
71105076|NCT03021486|141717264|OTHER|||||||0.71|||||||Wilcoxon Rank Sum Test|||||||0.71
71105077|NCT03021486|141717266|OTHER|||||||0.86|||||||Wilcoxon Rank Sum Test|||||||0.86
71105078|NCT03021486|141717267|OTHER|||||||0.12|||||||Two-tailed Fisher's exact test|||||||0.12
70930821|NCT00357682|141360932|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.04||||0.864|TWO_SIDED|95.0|0.67|1.61|||Accelerated Failure Time|||There are 81 diagnoses in the PPI dose comparison with adenocarcinoma oesophageal cancer as the endpoint. Median follow-up is 8.7 years IQR: (8.1 , 9.9)||1.61|0.67|0.864
70930822|NCT00357682|141360932|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.02||||0.921|TWO_SIDED|95.0|0.64|1.64|||Accelerated Failure Time|||There are 70 diagnoses of adenocarcinoma in the aspirin comparison. Median follow-up is 8.8 years, IQR: (8.1 , 10), Range: (0 , 11.5)||1.64|0.64|0.921
70930823|NCT00357682|141360933|SUPERIORITY|5% significance level is considered statistically significant.|Time Ratio|1.36||||0.119|TWO_SIDED|95.0|0.92|2.02|||Accelerated Failure Time|||There are 103 such diagnoses in the PPI dose comparison. Median follow-up is 8.7 years IQR: (8.1 , 9.9) Range: (0 , 11.48)||2.02|0.92|0.119
70930824|NCT00357682|141360933|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.51||||0.053|TWO_SIDED|95.0|1.0|2.29|||Accelerated Failure Time|||There are a total of 92 conversions to HGD in the aspirin comparison. Median follow-up is 8.8 years IQR (8.1 , 10.0) Range (0 , 11.5)||2.29|1.00|0.053
71105079|NCT03021486|141717268|OTHER|||||||0.007|||||||Two-tailed Fisher's exact test|||||||0.007
71105080|NCT03021486|141717269|OTHER|||||||0.83|||||||Two-tailed Fisher's exact test|||Perceived Comfort level as assessed by caregiver||||0.83
71105081|NCT03021486|141717269|OTHER|||||||0.82|||||||Two-tailed Fisher's exact test|||Perceived agitation level as assessed by caregiver||||0.82
71105082|NCT03021486|141717270|OTHER|||||||0.82|||||||Two-tailed Fisher's exact test|||Perceived Comfort level as assessed by nurse||||0.82
71105083|NCT03021486|141717270|OTHER|||||||0.91|||||||Two-tailed Fisher's exact test|||Perceived agitation level as assessed by nurse||||0.91
71105084|NCT03021486|141717271|OTHER|||||||0.12|||||||Wilcoxon Rank Sum Test|||Nursing assessment, disorientation to time - frequency||||0.12
70930825|NCT04955431|141360964|OTHER|We performed a 2-way Repeated Measures ANOVA to compare changes in blood IL-6 levels from baseline to post simulated firefighting on control days (Normal Sleep) and experimental days (Sleep Restriction).|||||<|0.05|||||||ANOVA|||||||<0.05
70930826|NCT04955431|141360965|OTHER|RM-ANOVA|||||>|0.05|||||||ANOVA|||||||>0.05
70930827|NCT03142009|141361006|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.021|TWO_SIDED|95.0|-0.45|-0.04|||Mixed Models Analysis|||||-.04|-.45|.021
70930828|NCT03142009|141361007|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.075|TWO_SIDED|95.0|-0.01|0.15|||Mixed Models Analysis|||||0.15|-.01|.075
70930829|NCT03215706|141361046|SUPERIORITY|Treatment A over Treatment B|Hazard Ratio (HR)|0.69||||0.0006|TWO_SIDED|95.0|0.56|0.86|||Log-rank test stratified|||||0.86|0.56|0.0006
70930830|NCT03215706|141361047|SUPERIORITY|Treatment A over Treatment B|Hazard Ratio (HR)|0.7||||0.0001|TWO_SIDED|95.0|0.58|0.84|||Log-rank test stratified|||||0.84|0.58|0.0001
71105085|NCT03021486|141717271|OTHER|||||||0.07|||||||Wilcoxon Rank Sum Test|||Nursing assessment, disorientation to place - frequency||||0.07
71105086|NCT03021486|141717271|OTHER|||||||0.051|||||||Wilcoxon Rank Sum Test|||Nursing assessment, visual hallucination - frequency||||0.051
70930831|NCT03215706|141361048|SUPERIORITY|Treatment A over Treatment B|Odds Ratio (OR)|1.81||||0.0003|TWO_SIDED|95.0|1.31|2.5|||Mantel Haenszel|||||2.50|1.31|0.0003
70930832|NCT05412004|141361066|SUPERIORITY||LS Mean Change difference|-20.01|||<|0.001|TWO_SIDED|95.0|-25.82|-14.2|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.||||-14.20|-25.82|<0.001
70930833|NCT05412004|141361066|SUPERIORITY||LS Mean Change difference|-23.77|||<|0.001|TWO_SIDED|95.0|-29.61|-17.93|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.||||-17.93|-29.61|<0.001
70930834|NCT05412004|141361067|SUPERIORITY||LS Mean Change difference|-47.65|||<|0.001|TWO_SIDED|95.0|-65.76|-29.55|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.||||-29.55|-65.76|<0.001
70930835|NCT05412004|141361067|SUPERIORITY||LS Mean Change difference|-56.21|||<|0.001|TWO_SIDED|95.0|-73.73|-38.7|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.||||-38.70|-73.73|<0.001
70930836|NCT05412004|141361068|SUPERIORITY||Risk Difference (RD)|42.77|||<|0.001|TWO_SIDED|95.0|30.76|54.79|||Regression, Logistic|||||54.79|30.76|<0.001
70930837|NCT05412004|141361068|SUPERIORITY||Risk Difference (RD)|48.6|||<|0.001|TWO_SIDED|95.0|36.55|60.65|||Regression, Logistic|||||60.65|36.55|<0.001
70930838|NCT05412004|141361069|SUPERIORITY||Risk Difference (RD)|28.74|||<|0.001|TWO_SIDED|95.0|18.27|39.22|||Regression, Logistic|||||39.22|18.27|<.001
70930839|NCT05412004|141361069|SUPERIORITY||Risk Difference (RD)|33.22|||<|0.001|TWO_SIDED|95.0|22.12|44.31|||Regression, Logistic|||||44.31|22.12|<0.001
70930840|NCT05412004|141361070|SUPERIORITY||Median Difference (Net)|-70.13|STANDARD_ERROR_OF_MEAN|10.619|||TWO_SIDED|95.0|-90.94|-49.31||||||||-49.31|-90.94|
70930841|NCT05412004|141361070|SUPERIORITY||Median Difference (Net)|-61.29|STANDARD_ERROR_OF_MEAN|11.921|||TWO_SIDED|95.0|-84.66|-37.93||||||||-37.93|-84.66|
70930842|NCT05412004|141361071|SUPERIORITY||LS Mean Change difference|-2.03||||0.037|TWO_SIDED|95.0|-3.95|-0.12|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||Sleep Disturbance||-0.12|-3.95|0.037
70930843|NCT05412004|141361071|SUPERIORITY||LS Mean Change difference|-3.43||||0.003|TWO_SIDED|95.0|-5.69|-1.17|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||Sleep Related Impairment||-1.17|-5.69|0.003
71105087|NCT03021486|141717271|OTHER|||||||0.048|||||||Wilcoxon Rank Sum Test|||Nursing assessment, tactile hallucination - frequency||||0.048
70930844|NCT05412004|141361071|SUPERIORITY||LS Mean Change difference|-3.9|||<|0.001|TWO_SIDED|95.0|-6.21|-1.58|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||Sleep Disturbance||-1.58|-6.21|<0.001
70930845|NCT05412004|141361071|SUPERIORITY||LS Mean Change difference|-4.26||||0.002|TWO_SIDED|95.0|-6.97|-1.56|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||Sleep-Related Impairment||-1.56|-6.97|0.002
70930846|NCT05412004|141361072|SUPERIORITY||LS Mean Change difference|-16.09|||<|0.001|TWO_SIDED|95.0|-17.99|-14.19|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||||-14.19|-17.99|<0.001
70930847|NCT05412004|141361072|SUPERIORITY||LS Mean Change difference|-17.28|||<|0.001|TWO_SIDED|95.0|-19.29|-15.28|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||||-15.28|-19.29|<.001
70930848|NCT05412004|141361073|SUPERIORITY||LS Mean Change difference|-0.71|STANDARD_ERROR_OF_MEAN|0.253||0.752|TWO_SIDED|95.0|-1.21|-0.22||ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.|ANCOVA|||||-0.22|-1.21|0.752
70930849|NCT05412004|141361073|SUPERIORITY||LS Mean Change difference|-1.04|STANDARD_ERROR_OF_MEAN|0.269||0.35|TWO_SIDED|95.0|-1.57|-0.51||ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.|ANCOVA|||||-0.51|-1.57|0.350
70930850|NCT05412004|141361074|SUPERIORITY||LS Mean Change difference|-7.62|||<|0.001|TWO_SIDED|95.0|-10.48|-4.77|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||||-4.77|-10.48|<0.001
70930851|NCT05412004|141361074|SUPERIORITY||LS Mean difference|-3.7||||0.017|TWO_SIDED|95.0|-6.75|-0.65|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||||-0.65|-6.75|0.017
70930852|NCT02720068|141361133|OTHER|Difference in Percentage|Mean Difference (Final Values)|7.5|||||TWO_SIDED|95.0|-7.3|22.9|||||Confidence interval based on Miettinen \& Nurminen method|||22.9|-7.3|
70930853|NCT05441449|141361151|SUPERIORITY|||||||0.002|||||||ANOVA|||||||0.002
70930854|NCT05441449|141361151|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
70930855|NCT05441449|141361151|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
70930856|NCT05441449|141361152|SUPERIORITY|||||||0.043|||||||ANOVA|||||||0.043
70930857|NCT05441449|141361152|SUPERIORITY|||||||0.281|||||||ANOVA|||||||0.281
70930858|NCT05441449|141361152|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
70930859|NCT05441449|141361153|SUPERIORITY|||||||0.352|||||||ANOVA|||||||0.352
70930860|NCT05441449|141361153|SUPERIORITY|||||||0.001|||||||ANOVA|||||||0.001
70930861|NCT05441449|141361154|SUPERIORITY|||||||0.374|||||||ANOVA|||||||0.374
70930862|NCT05441449|141361154|SUPERIORITY|||||||0.045|||||||ANOVA|||||||0.045
70930863|NCT05441449|141361154|SUPERIORITY|||||||0.196|||||||ANOVA|||||||0.196
70930864|NCT04319887|141361257|OTHER||||||||||||||||||statistical analysis section may be deleted|||
70930865|NCT05495945|141361289|SUPERIORITY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||||||0.62
70930866|NCT05495945|141361290|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
70930867|NCT05495945|141361291|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.20
70930868|NCT05495945|141361292|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
70941564|NCT05135156|141383858|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.54|TWO_SIDED|95.0|-2.0|3.7|||Regression, Linear||Estimation parameter is regression parameter comparing intervention to control|||3.7|-2.0|0.54
71105088|NCT03021486|141717271|OTHER|||||||0.15|||||||Wilcoxon Rank Sum Test|||Nursing assessment, auditory hallucination - frequency||||0.15
71105089|NCT03021486|141717271|OTHER|||||||0.1|||||||Wilcoxon Rank Sum Test|||Nursing assessment, delusional thoughts - frequency||||0.10
71016933|NCT03692078|141541628|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.353|||<|0.0001|TWO_SIDED|95.0|1.194|1.513|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||1.513|1.194|<.0001
71016934|NCT03692078|141541628|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.313|||<|0.0001|TWO_SIDED|95.0|1.153|1.472|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||1.472|1.153|<.0001
71016935|NCT03692078|141541628|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-0.956|||<|0.0001|TWO_SIDED|95.0|-1.155|-0.756|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||-0.756|-1.155|<.0001
71016936|NCT03692078|141541628|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.114|||<|0.0001|TWO_SIDED|95.0|-1.315|-0.913|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||-0.913|-1.315|<.0001
71016937|NCT03692078|141541628|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-0.999|||<|0.0001|TWO_SIDED|95.0|-1.195|-0.803|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||-0.803|-1.195|<.0001
71016938|NCT03692078|141541628|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.164|||<|0.0001|TWO_SIDED|95.0|-1.364|-0.964|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||-0.964|-1.364|<.0001
71016939|NCT03692078|141541628|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-0.775|||<|0.0001|TWO_SIDED|95.0|-0.969|-0.582|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||-0.582|-0.969|<.0001
71016940|NCT03692078|141541628|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-0.795|||<|0.0001|TWO_SIDED|95.0|-0.99|-0.6|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||-0.600|-0.990|<.0001
71105090|NCT03021486|141717271|OTHER|||||||0.15|||||||Wilcoxon Rank Sum Test|||Nursing assessment, psychomotor agitation- frequency||||0.15
71105091|NCT03021486|141717271|OTHER|||||||0.98|||||||Wilcoxon Rank Sum Test|||Nursing assessment, disorientation to time - distress||||0.98
71105092|NCT03021486|141717271|OTHER|||||||0.93|||||||Wilcoxon Rank Sum Test|||Nursing assessment, disorientation to place - distress||||0.93
71105093|NCT03021486|141717271|OTHER|||||||0.08|||||||Wilcoxon Rank Sum Test|||Nursing assessment, visual hallucination - distress||||0.08
71105094|NCT03021486|141717271|OTHER|||||||0.28|||||||Wilcoxon Rank Sum Test|||Nursing assessment, tactile hallucination - distress||||0.28
70941565|NCT05135156|141383860|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.82|TWO_SIDED|95.0|-2.1|2.7|||Regression, Linear||Difference = intervention - control|||2.7|-2.1|0.82
71105095|NCT03021486|141717271|OTHER|||||||0.83|||||||Wilcoxon Rank Sum Test|||Nursing assessment, auditory hallucination - distress||||0.83
70930869|NCT03868930|141361357|SUPERIORITY||||||<|0.0001||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Post-Treatment (T2).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on reintegration (measured by the Military to Civilian Questionnaire).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||<.0001
70930870|NCT03868930|141361357|SUPERIORITY||||||<|0.0001||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Follow-Up (T3).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on reintegration (measured by the Military to Civilian Questionnaire).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||<.0001
70930871|NCT03868930|141361357|SUPERIORITY||||||<|0.0001||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Post-Treatment (T2).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on reintegration (measured by the Military to Civilian Questionnaire).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||<.0001
70930872|NCT03868930|141361357|SUPERIORITY||||||<|0.0001||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Follow-Up (T3).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on reintegration (measured by the Military to Civilian Questionnaire).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||<.0001
70930873|NCT03868930|141361358|SUPERIORITY|||||||0.0044||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Post-Treatment (T2).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on readjustment (measured by the Post Deployment Readjustment Inventory).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups~Statistical analysis reported on the total score only."||||0.0044
70930874|NCT03868930|141361358|SUPERIORITY||||||<|0.0001||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Follow-Up (T3).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on readjustment (measured by the Post Deployment Readjustment Inventory).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups~Statistical analysis reported on the total score only."||||<.0001
70930875|NCT03868930|141361358|SUPERIORITY|||||||0.0162||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Post-Treatment (T2).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on readjustment (measured by the Post Deployment Readjustment Inventory).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups~Statistical analysis reported on the total score only."||||0.0162
70930876|NCT03868930|141361358|SUPERIORITY|||||||0.0009||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Follow-Up (T3).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on readjustment (measured by the Post Deployment Readjustment Inventory).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups~Statistical analysis reported on the total score only."||||0.0009
70930877|NCT03868930|141361359|SUPERIORITY|||||||0.014||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Post-Treatment (T2) Trait Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0140
70930878|NCT03868930|141361359|SUPERIORITY|||||||0.1548||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Post-Treatment (T2) State Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.1548
70930879|NCT03868930|141361359|SUPERIORITY|||||||0.0302||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Post-Treatment (T2) Anger Expression Index.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0302
70930880|NCT03868930|141361359|SUPERIORITY|||||||0.0158||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Post-Treatment (T2) Trait Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0158
70930881|NCT03868930|141361359|SUPERIORITY|||||||0.0034||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Post-Treatment (T2) State Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0034
71105096|NCT03021486|141717271|OTHER|||||||0.22|||||||Wilcoxon Rank Sum Test|||Nursing assessment, delusional thoughts - distress||||0.22
71105097|NCT03021486|141717271|OTHER|||||||0.75|||||||Wilcoxon Rank Sum Test|||Nursing assessment, psychomotor agitation - distress||||0.75
70930882|NCT03868930|141361359|SUPERIORITY|||||||0.8776||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Post-Treatment (T2) Anger Expression Index.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.8776
71105098|NCT03021486|141717272|OTHER|||||||0.09|||||||Wilcoxon Rank Sum Test|||||||0.09
71105099|NCT03021486|141717273|OTHER|||||||0.02|||||||Wilcoxon Rank Sum Test|||Mean change in pain.||||0.02
71105100|NCT03021486|141717273|OTHER|||||||0.1|||||||Wilcoxon Rank Sum Test|||Mean change in Fatigue.||||0.10
71016941|NCT03692078|141541628|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.514||||0.0002|TWO_SIDED|95.0|-0.836|-0.193|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.193|-0.836|0.0002
70930883|NCT03868930|141361359|SUPERIORITY|||||||0.0002||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Follow-Up (T3) Trait Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0002
70930884|NCT03868930|141361359|SUPERIORITY|||||||0.0198||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Follow-Up (T3) State Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0198
70930885|NCT03868930|141361359|SUPERIORITY|||||||0.0013||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Follow-Up (T3) Anger Expression Index.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0013
70930886|NCT03868930|141361359|SUPERIORITY||||||<|0.0001||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy Group from Baseline (T1) to Follow-Up (T3) Trait Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||<.0001
70930887|NCT03868930|141361359|SUPERIORITY|||||||0.0345||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Follow-Up (T3) State Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||.0345
70930888|NCT03868930|141361359|SUPERIORITY|||||||0.5918||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Follow-Up (T3) Anger Expression Index.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.5918
70930889|NCT04664881|141361408|SUPERIORITY|||||||0.71|||||||Chi-squared, Corrected|||||||0.71
70930890|NCT04664881|141361409|SUPERIORITY|||||||0.99|||||||Chi-squared, Corrected|||Cardiovascular Death||||0.99
70930891|NCT04664881|141361409|SUPERIORITY|||||||0.36|||||||Chi-squared, Corrected|||Hospitalization for Myocardial Infarction||||0.36
71016942|NCT03692078|141541628|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.484||||0.0005|TWO_SIDED|95.0|-0.808|-0.16|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.160|-0.808|0.0005
71077890|NCT02913105|141664398|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.95||||0.4817|TWO_SIDED|90.0|0.85|1.07|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 14||1.07|0.85|0.4817
70930892|NCT04664881|141361409|SUPERIORITY|||||||0.13|||||||Chi-squared, Corrected|||Arrhythmias||||0.13
70930893|NCT04664881|141361409|SUPERIORITY|||||||0.99|||||||Chi-squared, Corrected|||Cardiac Arrest||||0.99
70930894|NCT02231749|141361410|SUPERIORITY||Stratified Difference|16.0|||<|0.0001|TWO_SIDED|95.0|9.8|22.2|||DerSimonian and Laird Test|||||22.2|9.8|<0.0001
70930895|NCT02231749|141361411|SUPERIORITY||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|99.8|0.44|0.89|||Log Rank|||||0.89|0.44|<0.0001
70930896|NCT02231749|141361412|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0331|TWO_SIDED|99.1|0.64|1.05|||Log Rank|||||1.05|0.64|0.0331
70930897|NCT02231749|141361413|SUPERIORITY||Stratified Difference|7.2||||0.0191|TWO_SIDED|95.0|1.8|12.7|||DerSimonian and Laird Test|||||12.7|1.8|0.0191
70930898|NCT02231749|141361414|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0003|TWO_SIDED|99.8|0.49|0.95|||Log Rank|||||0.95|0.49|0.0003
70930899|NCT02231749|141361415|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.8498|TWO_SIDED|99.1|0.79|1.23|||Log Rank|||||1.23|0.79|0.8498
70941566|NCT05135156|141383862|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.44|TWO_SIDED|95.0|-15.0|7.0|||Regression, Linear||Estimation parameter is regression parameter comparing intervention to control|||7|-15|0.44
70930900|NCT04868656|141361426|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.15|TWO_SIDED|95.0|-5.0|0.8|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); adjusted length of stay (greater than or equal to 4.7 days versus less than 4.7 days); prior implementation of STRIDE (yes vs. no).||0.8|-5.0|0.15
70930901|NCT04868656|141361427|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.34|TWO_SIDED|95.0|-6.0|16.6|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); adjusted length of stay (greater than or equal to 4.7 days versus less than 4.7 days); prior implementation of STRIDE (yes vs. no).||16.6|-6.0|0.34
70930902|NCT04868656|141361428|SUPERIORITY||Odds Ratio (OR)|0.6||||0.23|TWO_SIDED|95.0|0.1|2.5|||Regression, Logistic|||Model includes the arm indicator variable only; model does not include stratification variables due to potential for overfitting.||2.5|0.1|0.23
70930903|NCT02951052|141361489|NON_INFERIORITY|Non-inferiority in the proportion of participants with virologic failure at Week 48 (per FDA's snapshot algorithm for assessing HIV-1 RNA \>=50 copies/mL) can be concluded if the upper bound of a two-sided 95% confidence interval for the difference in failure rates between the two treatment arms (CAB - current ART) is not more than 6%.|Adjusted difference in proportion|0.6|||||TWO_SIDED|95.0|-1.2|2.5|||||Adjusted difference in proportion was based on Cochran-Mantel Haenszel stratified analysis adjusting for the following baseline stratification factors: sex at birth (Male, Female) and Baseline third agent (PI, NNRTI, INI).|||2.5|-1.2|
70930904|NCT02951052|141361490|NON_INFERIORITY|Non-inferiority in the proportion of participants with HIV-1 RNA\<50 c/mL at Week 48 (per FDA's snapshot algorithm) can be concluded if the lower bound of a two-sided 95% confidence interval for the difference in success rates between the two treatment arms (CAB - current ART) is more than -10%.|Adjusted difference in proportion|-3.0|||||TWO_SIDED|95.0|-6.7|0.7|||||Adjusted difference in proportion was based on Cochran-Mantel Haenszel stratified analysis adjusting for the following baseline stratification factors: sex at birth (Male, Female) and Baseline third agent (PI, NNRTI, INI).|||0.7|-6.7|
70930905|NCT02951052|141361564|OTHER||Adjusted difference|-0.1||||0.944|TWO_SIDED|95.0|-2.4|2.2|||ANCOVA||Treatment comparison at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||2.2|-2.4|0.944
70930906|NCT02951052|141361564|OTHER||Adjusted difference|1.0||||0.385|TWO_SIDED|95.0|-1.3|3.4|||ANCOVA||Treatment comparison at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|||3.4|-1.3|0.385
70930907|NCT02951052|141361565|OTHER||Adjusted difference|4.9|||<|0.001|TWO_SIDED|95.0|2.8|7.1|||ANCOVA||Treatment comparison at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||7.1|2.8|<0.001
70930908|NCT02951052|141361565|OTHER||Adjusted difference|6.4|||<|0.001|TWO_SIDED|95.0|4.0|8.8|||ANCOVA||Treatment comparison at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|||8.8|4.0|<0.001
70930909|NCT02951052|141361566|OTHER||Adjusted difference|5.3||||0.008|TWO_SIDED|95.0|1.4|9.1|||ANCOVA||Treatment comparison at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||9.1|1.4|0.008
70930910|NCT02951052|141361566|OTHER||Adjusted difference|2.0||||0.347|TWO_SIDED|95.0|-2.2|6.2|||ANCOVA||||Treatment comparison at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|6.2|-2.2|0.347
70930911|NCT02951052|141361567|OTHER||Adjusted difference|0.2||||0.344|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA||Treatment comparison of SF-12 total scores at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||0.7|-0.2|0.344
70930912|NCT02951052|141361567|OTHER||Adjusted difference|-0.1||||0.785|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA||Treatment comparison of SF-12 total scores at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|||0.4|-0.6|0.785
70930913|NCT02951052|141361567|OTHER||Adjusted difference|0.676||||0.282|TWO_SIDED|95.0|-0.557|1.909|||ANCOVA||Treatment comparison of SF-12 MCS at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||1.909|-0.557|0.282
70930914|NCT02951052|141361567|OTHER||Adjusted difference|0.635||||0.327|TWO_SIDED|95.0|-0.637|1.907|||ANCOVA||Treatment comparison of SF-12 MCS at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|||1.907|-0.637|0.327
70930915|NCT02951052|141361567|OTHER||Adjusted difference|0.697||||0.086|TWO_SIDED|95.0|-0.1|1.494|||ANCOVA||Treatment comparison of SF-12 PCS at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||1.494|-0.100|0.086
70930916|NCT02951052|141361567|OTHER||Adjusted difference|0.696||||0.092|TWO_SIDED|95.0|-0.113|1.505|||ANCOVA||Treatment comparison of SF-12 PCS at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|||1.505|-0.113|0.092
70930917|NCT02951052|141361570|OTHER||Adjusted difference|7.9|||<|0.001|TWO_SIDED|95.0|4.1|11.7|||ANCOVA||Treatment comparison at Week 8 for the groups CAB LA+ RPV LA and current ART is presented.|||11.7|4.1|<0.001
70930918|NCT02951052|141361570|OTHER||Adjusted difference|6.9|||<|0.001|TWO_SIDED|95.0|3.3|10.4|||ANCOVA||Treatment comparison Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||10.4|3.3|<0.001
70930919|NCT02951052|141361570|OTHER||Adjusted difference|10.7|||<|0.001|TWO_SIDED|95.0|7.1|14.4|||ANCOVA||Treatment comparison at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|||14.4|7.1|<0.001
70930920|NCT00650078|141361613|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.25||||0.001|TWO_SIDED|95.0|1.39|3.64||The p-value was based on logistic regression with treatment, geographic region, gender, and median age class as factors.|Regression, Logistic|||||3.64|1.39|0.0010
70930921|NCT00650078|141361614|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-19.6||||0.0015|TWO_SIDED|95.0|-31.7|-6.1||Wilcoxon Rank Sum Test p-value|Hodges-Lehman method|The difference between the treatment groups was assessed using the median and the 95% CI of the median computed using the Hodges Lehmann method.||||-6.1|-31.7|0.0015
70930922|NCT01046825|141361684|SUPERIORITY|||||||0.555|||||||Log Rank|||||||0.5550
70930923|NCT01046825|141361685|SUPERIORITY|||||||0.3605|||||||Log Rank|||||||0.3605
70930924|NCT01046825|141361686|SUPERIORITY|||||||0.6181|||||||Chi-squared|||||||0.6181
70930925|NCT00624442|141361698|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|1.0||||0.8842|TWO_SIDED|95.0|-7.0|8.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||8|-7|0.8842
71105101|NCT03021486|141717273|OTHER|||||||0.02|||||||Wilcoxon Rank Sum Test|||Mean change in Nausea.||||0.02
71105102|NCT03021486|141717273|OTHER|||||||0.97|||||||Wilcoxon Rank Sum Test|||Mean change in Depression.||||0.97
71105103|NCT03021486|141717273|OTHER|||||||0.03|||||||Wilcoxon Rank Sum Test|||Mean change in Anxiety.||||0.03
70930926|NCT00624442|141361698|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|18.0|||<|0.0001|TWO_SIDED|95.0|10.0|27.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||27|10|<0.0001
70930927|NCT00624442|141361698|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|47.0|||<|0.0001||95.0|38.0|56.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||56|38|<0.0001
70930928|NCT00624442|141361698|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|58.0|||<|0.0001|TWO_SIDED|95.0|46.0|70.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||70|46|<0.0001
70930929|NCT00624442|141361698|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|59.0|||<|0.0001|TWO_SIDED|95.0|47.0|72.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||72|47|<0.0001
70930930|NCT00624442|141361698|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|80.0|||<|0.0001|TWO_SIDED|95.0|71.0|89.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||89|71|<0.0001
70930931|NCT00624442|141361698|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis based on the following model: Change from baseline = Concentration + Baseline + Error, treating patients as random effect||"All available concentration data are used in the model as a continuous variable.~p-value based on individual plasma concentration of CK-1827452 vs. corresponding systolic ejection time PD assessment (not binned based on plasma concentration)"||||<0.0001
70930932|NCT00624442|141361699|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|1.0||||0.3665|TWO_SIDED|95.0|-1.0|2.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||2|-1|0.3665
70930933|NCT00624442|141361699|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|1.0|||<|0.0357|TWO_SIDED|95.0|0.0|3.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||3|0|<0.0357
70930934|NCT00624442|141361699|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|3.0||||0.0004|TWO_SIDED|95.0|1.0|5.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||5|1|0.0004
70930935|NCT00624442|141361699|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|3.0||||0.0086|TWO_SIDED|95.0|1.0|4.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||4|1|0.0086
70930936|NCT00624442|141361699|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|2.0||||0.032|TWO_SIDED|95.0|0.0|5.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||5|0|0.032
70941567|NCT05135156|141383863|SUPERIORITY||Mean Difference (Net)|1.3||||0.31|TWO_SIDED|95.0|-1.3|3.9|||Regression, Linear||Estimation parameter is regression parameter comparing intervention to control|||3.9|-1.3|0.31
71105104|NCT03021486|141717273|OTHER|||||||0.68|||||||Wilcoxon Rank Sum Test|||Mean change in Drowsiness.||||0.68
71105105|NCT03021486|141717273|OTHER|||||||0.8|||||||Wilcoxon Rank Sum Test|||Mean change in Appetite.||||0.80
71105106|NCT03021486|141717273|OTHER|||||||0.45|||||||Wilcoxon Rank Sum Test|||Mean change in Feeling of well being.||||0.45
71105107|NCT03021486|141717273|OTHER|||||||0.16|||||||Wilcoxon Rank Sum Test|||Mean change in Shortness of breath.||||0.16
71105108|NCT03021486|141717273|OTHER|||||||0.12|||||||Wilcoxon Rank Sum Test|||Mean change in Sleep.||||0.12
70930937|NCT00624442|141361699|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|5.0|||<|0.0001|TWO_SIDED|95.0|3.0|6.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||6|3|<0.0001
70930938|NCT00624442|141361699|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis based on the following model: Change from baseline = Concentration + Baseline + Error, treating patients as random effect||"All available concentration data are used in the model as a continuous variable.~p-value based on individual plasma concentration of CK-1827452 vs. corresponding fractional shortening PD assessment (not binned based on plasma concentration)"||||<0.0001
70930939|NCT00003222|141361733|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||Chi-squared|||This is a test for differences between the response rates of the two arms. The null hypothesis is that the arms have equal response rates and the alternative hypothesis is that they are different.||||0.13
70930940|NCT00003222|141361734|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared|||This is a test for differences between the response rates of the two arms. The null hypothesis is that the arms have equal response rates and the alternative hypothesis is that they are different.||||0.004
70930941|NCT04757753|141361797|NON_INFERIORITY|"πN = 2-year successful treatment rate of PA1704 πR = 2-year successful treatment rate of BioRoot™ RCS Δ = πN - πR ΔL = non-inferiority margin fixed to 13% or 0.13~Hypotheses are :~H0 : Δ ≤ -ΔL H1 : Δ \> -ΔL The χ2 of Dunnett \& Gent is used to assess the non-inferiority"|Mean Difference (Final Values)|0.006||||0.03|TWO_SIDED|90.0|-0.0074|0.0087||A priori threshold for statistical significance was \< 0.05|Chi-squared, Corrected|||The statistical analysis was done on the proportion difference of the treatment efficacy, defined on loose criteria, at 24 months, in PP population.||0.0087|-0.0074|0.03
70930942|NCT00391443|141361873|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85||||0.211|TWO_SIDED|95.0|0.658|1.097|||Log Rank|||||1.097|0.658|0.2110
70930943|NCT00391443|141361874|SUPERIORITY_OR_OTHER_LEGACY||Relative risk reduction|0.17||||0.2542|TWO_SIDED|95.0|-0.13|0.39|||Fisher Exact|||||0.39|-0.13|0.2542
70930944|NCT04079517|141361876|NON_INFERIORITY|Comparing mean difference in symptom score (95% confidence intervals). Post hoc analysis. Not powered, but to give an indication of differences between standard dose (20mg) and the non-approved dose (10mg).|Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0|||||||Post hoc analysis. Not powered, but to give an indication on differences in symptom score between standard dose (20mg) and the non-approved dose (10mg).||Post hoc analysis. Not powered, but to give an indication on differences between standard dose (20mg) and the non-approved dose (10mg).|||
70930945|NCT04518943|141361911|SUPERIORITY||Mean Difference (Net)|-634.0||||0.418|TWO_SIDED|90.0|-1924.0|655.0|||linear mixed model|||This is the results of financial vs non-financial reward factor at week 12. It compares change in steps from baseline to week 12 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignment, linear week with a spline at week 12, and interactions between factors and weeks.||655|-1924|0.418
70930946|NCT04518943|141361911|SUPERIORITY||Mean Difference (Net)|-1697.0||||0.033|TWO_SIDED|90.0|-3000.0|-385.0|||Mixed Models Analysis||Positive values represent a positive effect of lottery based rewards compared to loss-based rewards.|This is the results of lottery vs loss-framed reward factor at week 12. It compares change in steps from baseline to week 12 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.||-385|-3000|0.033
70930947|NCT04518943|141361911|SUPERIORITY||Mean Difference (Net)|820.0||||0.248|TWO_SIDED|90.0|-347.0|1988.0|||Mixed Models Analysis|||This is the results of precommitment (PC) vs no PC factor at week 12. It compares change in steps from baseline to week 12 between subjects randomized to receive a request for PC compared to those who received no request. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.||1988|-347|0.248
70930948|NCT04518943|141361911|SUPERIORITY||Mean Difference (Net)|1121.0||||0.125|TWO_SIDED|90.0|82.0|2323.0|||Mixed Models Analysis|||This is the results of advice vs no advice factor at week 12. It compares change in steps from baseline to week 12 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.|Positive values represent a positive effect of requests for advice on steps compared to no request for advice.|2323|82|0.125
70930949|NCT04518943|141361912|SUPERIORITY||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|0.53||0.739|TWO_SIDED|90.0|-1.05|0.7|||Regression, Linear|||This is the results of financial vs non-financial reward factor at week 12. It compares change in efficacy from baseline to week 12 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.|Positive values represent a positive effect of financial rewards compared to non-financial rewards.|0.70|-1.05|0.739
70930950|NCT04518943|141361912|SUPERIORITY||Mean Difference (Net)|-0.51||||0.347|TWO_SIDED|90.0|-1.42|0.39|||Mixed Models Analysis||Positive values represent a positive effect of financial rewards compared to non-financial rewards.|This is the results of financial vs non-financial reward factor at week 24. It compares change in efficacy from baseline to week 24 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.39|-1.42|0.347
70941568|NCT05135156|141383864|SUPERIORITY||Mean Difference (Net)|5.0||||0.42|TWO_SIDED|95.0|-7.4|17.4|||Regression, Linear||Difference = intervention - control||Estimation parameter is regression parameter comparing intervention to control|17.4|-7.4|0.42
70930951|NCT04518943|141361912|SUPERIORITY||Mean Difference (Net)|0.61||||0.293|TWO_SIDED|90.0|-0.35|1.57|||Mixed Models Analysis||Positive values represent a positive effect of lottery-based rewards compared to loss-based rewards.|This is the results of lottery vs loss-framed reward factor at week 12. It compares change in efficacy from baseline to week 12 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||1.57|-0.35|0.293
70930952|NCT04518943|141361912|SUPERIORITY||Mean Difference (Net)|0.31||||0.599|TWO_SIDED|90.0|-0.67|1.3|||Mixed Models Analysis||Positive values represent a positive effect of lottery-based rewards compared to loss-based rewards.|This is the results of lottery vs loss-framed reward factor at week 24. It compares efficacy at week 24 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||1.30|-0.67|0.599
70930953|NCT04518943|141361912|SUPERIORITY||Mean Difference (Net)|1.49||||0.007|TWO_SIDED|90.0|0.58|2.4|||Regression, Linear|||This is the results of precommitment (PC) vs no PC factor at week 12. It compares efficacy at week 12 between subjects randomized to receive a request for PC to other subjects compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||2.40|0.58|0.007
70930954|NCT04518943|141361912|SUPERIORITY||Mean Difference (Net)|1.78||||0.002|TWO_SIDED|90.0|0.86|2.7|||Regression, Linear|||This is the results of precommitment (PC) vs no PC factor at week 24. It compares efficacy at week 24 between subjects randomized to receive a request for PC compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||2.70|0.86|0.002
70930955|NCT04518943|141361912|SUPERIORITY||Mean Difference (Net)|1.02||||0.068|TWO_SIDED|90.0|0.1|1.94|||Regression, Linear|||This is the results of advice vs no-advice factor at week 12. It compares efficacy at week 12 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||1.94|0.10|0.068
70930956|NCT04518943|141361912|SUPERIORITY||Mean Difference (Net)|0.19||||0.74|TWO_SIDED|90.0|-0.76|1.14|||Regression, Linear|||This is the results of advice vs no-advice factor at week 24. It compares efficacy at week 24 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||1.14|-0.76|0.740
70930957|NCT04518943|141361913|SUPERIORITY||Mean Difference (Net)|0.14||||0.481|TWO_SIDED|90.0|-0.19|0.47|||Regression, Linear|||This is the results of financial vs non-financial reward factor at week 12. It compares intrinsic motivation in week 12 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator..||0.47|-0.19|0.481
70930958|NCT04518943|141361913|SUPERIORITY||Mean Difference (Net)|0.18||||0.388|TWO_SIDED|90.0|-0.16|0.52|||Regression, Linear|||This is the results of financial vs non-financial reward factor at week 24. It compares intrinsic motivation in week 24 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.52|-0.16|0.388
70930959|NCT04518943|141361913|SUPERIORITY||Mean Difference (Net)|-0.02||||0.926|TWO_SIDED|90.0|-0.38|0.34|||Regression, Linear|||This is the results of lottery vs loss-framed reward factor at week 12. It compares intrinsic motivation at week 12 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.34|-0.38|0.926
70930960|NCT04518943|141361913|SUPERIORITY||Mean Difference (Net)|-0.17||||0.446|TWO_SIDED|90.0|-0.54|0.2|||Regression, Linear|||This is the results of lottery vs loss-framed reward factor at week 24. It compares intrinsic motivation at week 24 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.20|-0.54|0.446
70930961|NCT04518943|141361913|SUPERIORITY||Mean Difference (Net)|0.08||||0.711|TWO_SIDED|90.0|-0.27|0.42|||Regression, Linear|||This is the results of precommitment (PC) vs no PC factor at week 12. It compares intrinsic motivation at week 12 between subjects randomized to receive a request for PC to compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.42|-0.27|0.711
70930962|NCT04518943|141361913|SUPERIORITY||Mean Difference (Net)|-0.2||||0.345|TWO_SIDED|90.0|-0.55|0.15|||Regression, Linear|||This is the results of precommitment (PC) vs no PC factor at week 24. It compares efficacy at week 24 between subjects randomized to receive a request for PC to compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.15|-0.55|0.345
70930963|NCT04518943|141361913|SUPERIORITY||Mean Difference (Net)|0.02||||0.928|TWO_SIDED|90.0|-0.33|0.36|||Regression, Linear|||This is the results of advice vs no-advice factor at week 12. It compares intrinsic motivation at week 12 between subjects randomized to receive a request for advice compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.36|-0.33|0.928
70930964|NCT04518943|141361913|SUPERIORITY||Mean Difference (Net)|-0.19||||0.372|TWO_SIDED|90.0|-0.55|0.16|||Regression, Linear|||This is the results of advice vs no-advice factor at week 24. It compares intrinsic motivation at week 24 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.16|-0.55|0.372
70930965|NCT04518943|141361914|SUPERIORITY||Mean Difference (Net)|0.35||||0.767|TWO_SIDED|90.0|-1.6|2.3|||Regression, Linear|||This is the results of financial vs non-financial reward factor at week 12. It compares phq8 mental health scores in week 12 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||2.3|-1.60|0.767
70930966|NCT04518943|141361914|SUPERIORITY||Mean Difference (Net)|0.78||||0.5|TWO_SIDED|90.0|-1.12|2.69|||Regression, Linear|||This is the results of financial vs non-financial reward factor at week 24. It compares phq8 mental health scores in week 24 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||2.69|-1.12|0.500
70930967|NCT04518943|141361914|SUPERIORITY||Mean Difference (Net)|0.59||||0.631|TWO_SIDED|90.0|-1.43|2.61|||Regression, Linear|||This is the results of lottery vs loss-framed reward factor at week 12. It compares phq8 mental health scores at week 12 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24, and interactions between factors and weeks.||2.61|-1.43|0.631
70930968|NCT04518943|141361914|SUPERIORITY||Mean Difference (Net)|-0.62||||0.62|TWO_SIDED|90.0|-2.69|1.44|||Regression, Linear|||This is the results of lottery vs loss-framed reward factor at week 24. It compares phq8 mental health scores at week 24 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24, and interactions between factors and weeks.||1.44|-2.69|0.620
70930969|NCT04518943|141361914|SUPERIORITY||Mean Difference (Net)|0.17||||0.886|TWO_SIDED|90.0|-1.77|2.12|||Regression, Linear|||This is the results of pre-commitment (PC) vs no PC factor at week 12. It compares phq8 mental health scores at week 12 between subjects randomized to receive a request for PC to compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||2.12|-1.77|0.886
70930970|NCT04518943|141361914|SUPERIORITY||Mean Difference (Net)|-0.07||||0.95|TWO_SIDED|-2.03|-2.03|1.88|||Regression, Linear|||This is the results of precommitment (PC) vs no PC factor at week 24. It compares phq8 mental health scores at week 24 between subjects randomized to receive a request for PC to compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||1.88|-2.03|0.950
70930971|NCT04518943|141361914|SUPERIORITY||Mean Difference (Net)|-1.45||||0.248|TWO_SIDED|90.0|-3.51|0.61|||Regression, Linear|||This is the results of advice vs no-advice factor at week 12. It compares phq mental health scores at week 12 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.61|-3.51|0.248
70930972|NCT04518943|141361914|SUPERIORITY||Mean Difference (Net)|-1.23||||0.317|TWO_SIDED|90.0|-3.25|0.79|||Regression, Linear|||This is the results of advice vs no-advice factor at week 24. It compares phq mental health scores at week 24 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.79|-3.25|0.317
70930973|NCT04518943|141361915|SUPERIORITY||Mean Difference (Net)|-35.0||||0.972|TWO_SIDED|90.0|-1685.0|1616.0|||Mixed Models Analysis|||This is the results of financial vs non-financial reward factor at week 24. It compares change in steps from baseline to week 24 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.||1616|-1685|0.972
70941569|NCT05135156|141383865|OTHER|Pearson's chi-squared test of independence||||||0.39||||||p=0.39 at baseline, 0.39 at 2 weeks and 0.23 at 4 weeks|Chi-squared|||||||0.39
70930974|NCT04518943|141361915|SUPERIORITY||Mean Difference (Net)|-2428.0||||0.019|TWO_SIDED|90.0|-4134.0|-722.0|||Mixed Models Analysis||Positive values represent a positive effect of lottery-based rewards compared to loss-based rewards.|This is the results of lottery vs loss-framed reward factor at week 24. It compares change in steps from baseline to week 24 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.||-722|-4134|0.019
70930975|NCT04518943|141361915|SUPERIORITY||Mean Difference (Net)|418.0||||0.627|TWO_SIDED|90.0|-999.0|1836.0|||Mixed Models Analysis|||This is the results of precommitment (PC) vs no PC factor at week 24. It compares change in steps from baseline to week 24 between subjects randomized to receive a request for PC compared to those who received no request. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.||1836|-999|0.627
70930976|NCT04518943|141361915|SUPERIORITY||Mean Difference (Net)|195.0||||0.842|TWO_SIDED|90.0|-1417.0|1807.0|||Mixed Models Analysis|||This is the results of advice vs no advice factor at week 24. It compares change in steps from baseline to week 24 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.||1807|-1417|0.842
70930977|NCT02701283|141361950|NON_INFERIORITY|Absolute non-inferiority margin was 0.06|Posterior Median of the Difference|0.999|||||TWO_SIDED|95.0||||The posterior probability of non-inferiority is \> 0.999. The posterior probability is the probability of the event rate by updating the prior probability distribution with observed data at the interim analysis using Bayes' Theorem.|Bayesian||95% Bayesian credible interval for the difference (TAVR-SAVR) was (-4.4%, 0.4%). The 95% credible interval is the 2.5th and 97.5th percentiles of the posterior distribution.|Primary Hypothesis: TAVR with the Medtronic TAVR system is non-inferior to SAVR for all-cause mortality or disabling stroke rate during a fixed follow-up of 24 months for the Randomized Controlled Trial||||
70930978|NCT01830595|141361986|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
70930979|NCT01830595|141361988|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
70930980|NCT01830595|141361989|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.10
70930981|NCT04940624|141361990|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-15.64|||=|0.061|TWO_SIDED|95.0|-31.3|0.24||The p-value was calculated by Rank Analysis of Covariance (ANCOVA) model using treatment group, age stratum (≤6 years, \>6 years), and rank of Baseline seizure frequency per 28 days as predictors.|ANCOVA||The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% confidence interval (CI) were based on the Hodges-Lehmann estimation.|||0.24|-31.30|=0.061
70930982|NCT04940624|141361991|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-14.29|||=|0.089|TWO_SIDED|95.0|-30.51|1.53||The p-value was calculated by the Rank ANCOVA model using treatment group, age stratum (≤6 years, \>6 years), and rank of baseline seizure frequency per 28 days as predictors.|ANCOVA||The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% CI were based on the Hodges-Lehmann estimation.|||1.53|-30.51|=0.089
70930983|NCT04940624|141361992|SUPERIORITY||Odds Ratio (OR)|3.22|||=|0.01|TWO_SIDED|95.0|1.3|7.96|||Cochran-Mantel-Haenszel|The p-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by age stratum (≤6 years, \>6 years).||||7.96|1.30|=0.010
71105109|NCT04795531|141717275|NON_INFERIORITY|Non-inferiority of insulin icodec was considered confirmed if the upper limit of the two-sided 95% confidence interval (CI) for mean treatment difference (insulin icodec minus insulin degludec) was strictly below 0.3%.|Treatment difference|-0.21|||<|0.0001|TWO_SIDED|95.0|-0.34|-0.08|||ANCOVA|||The response and change from baseline in response after 26 weeks are analysed using an analysis of covariance (ANCOVA) model with treatment, region and sulfonylureas (SU)/glinides use as fixed factors, and baseline response as covariate.||-0.08|-0.34|<0.0001
70930984|NCT04940624|141361993|SUPERIORITY||Odds Ratio (OR)|3.59|||=|0.008|TWO_SIDED|95.0|1.36|9.49|||Cochran-Mantel-Haenszel|The p-value was based on CMH test stratified by age stratum (≤6 years, \>6 years).||||9.49|1.36|=0.008
70930985|NCT04940624|141361995|SUPERIORITY||Odds Ratio (OR)|2.51|||=|0.004|TWO_SIDED|95.0|1.33|4.72|||Cumulative Logit Model|P-value was calculated using the Cumulative Logit model including treatment and age group as factors.||||4.72|1.33|=0.004
70930986|NCT04940624|141361996|SUPERIORITY||Odds Ratio (OR)|2.58|||=|0.003|TWO_SIDED|95.0|1.37|4.87|||Cumulative Logit Model|P-value was calculated using the Cumulative Logit model including treatment and age group as factors.||||4.87|1.37|=0.003
70930987|NCT04940624|141361997|SUPERIORITY||Odds Ratio (OR)|1.12|||=|0.741|TWO_SIDED|95.0|0.56|2.26|||Cumulative Logit Model|P-value was calculated using the Cumulative Logit model including treatment and age group as factors.||Alertness||2.26|0.56|=0.741
70930988|NCT04940624|141361997|SUPERIORITY||Odds Ratio (OR)|1.04|||=|0.901|TWO_SIDED|95.0|0.54|2.02|||Cumulative Logit Model|P-value was calculated using the Cumulative Logit model including treatment and age group as factors.||Communication||2.02|0.54|=0.901
70930989|NCT04940624|141361997|SUPERIORITY||Odds Ratio (OR)|1.15|||=|0.693|TWO_SIDED|95.0|0.58|2.28|||Cumulative Logit Model|P-value was calculated using the Cumulative Logit model including treatment and age group as factors.||Disruptive Behaviors||2.28|0.58|=0.693
70930990|NCT04940624|141361998|SUPERIORITY||Least Square Mean Difference|-3.03|||=|0.189|TWO_SIDED|95.0|-7.59|1.52||P-value was based on MMRM analysis with change from baseline as outcome and baseline score as fixed continuous effect; treatment group, age stratum, analysis visit, and analysis visit by treatment group interaction as fixed categorical effects.|MMRM|||||1.52|-7.59|=0.189
70930991|NCT04940624|141361999|SUPERIORITY||Odds Ratio (OR)|3.65|||<|0.001|TWO_SIDED|95.0|1.87|7.13|||Cumulative Logit Model|P-value was calculated using the Cumulative Logit model including treatment and age group as factors.||||7.13|1.87|<0.001
70930992|NCT04940624|141362000|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-9.97|||=|0.565|TWO_SIDED|95.0|-29.01|7.87|||ANCOVA|The Rank ANCOVA model used treatment group, age stratum (≤6 years, \>6 years), and rank of Baseline seizure frequency per 28 days as predictors.|The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% CI were based on the Hodges-Lehmann estimation.|||7.87|-29.01|=0.565
70930993|NCT04940624|141362001|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-8.13|||=|0.637|TWO_SIDED|94.0|-26.31|10.13|||ANCOVA|The Rank ANCOVA model used treatment group, age stratum (≤6 years, \>6 years), and rank of Baseline seizure frequency per 28 days as predictors.|The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% CI were based on the Hodges-Lehmann estimation.|||10.13|-26.31|=0.637
70930994|NCT04940624|141362002|SUPERIORITY||Least Square Mean Difference|0.79|||||TWO_SIDED|95.0|-3.81|5.4|||||A linear model with treatment group and age stratum as factors and baseline percentage as a covariate was used for analysis.|||5.40|-3.81|
70930995|NCT04940624|141362003|SUPERIORITY||Least Square Mean Difference|5.6|||||TWO_SIDED|95.0|0.1|11.2||||||||11.2|0.1|
70930996|NCT04940624|141362004|SUPERIORITY||Least Square Mean Difference|-1.1|||||TWO_SIDED|95.0|-3.1|1.0|||||Least square mean difference was estimated using a linear model with treatment group and age stratum as factors.|||1.0|-3.1|
70930997|NCT02382003|141362005|SUPERIORITY||Mean Difference (Net)|10.73||||0.005|TWO_SIDED|||||=Positive\~No-training, 0.030=Positive\~50/50 training, 0.833=50/50\~No-training Alpha = .05|Likelihood Ratio Tests|2=df Positive\~No-training, 2=df Positive\~50/50 training, 2=df 50/50\~No-training|=Positive\~No-training, 7.053=Positive\~50/50 training, 0.366=50/50\~No-training|Effect of CBM-I condition: The main effect of CBM-I was represented by three binary variables in the main effect models (Positive vs. No-training control; 50/50 vs. No- training control; Positive vs. 50/50). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||0.005
70930998|NCT02382003|141362005|SUPERIORITY||Mean Difference (Net)|0.449||||0.799|TWO_SIDED|||||=Neutral\~Anxiety prime Alpha = .05|Likelihood Ratio Tests|2=df Neutral\~Anxiety prime|=Neutral\~Anxiety prime|Effect of Imagery Prime Type: The main effect of imagery prime was represented by one binary variable (neutral vs. anxiety imagery). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||0.799
70930999|NCT02382003|141362005|SUPERIORITY||Mean Difference (Net)|9.085||||0.011|TWO_SIDED|||||=No-train+Neut\~Pos+Anx, 0.026=No-train+Neut\~Pos+Neut, 0.094=No-train+Anx\~Pos+Anx, 0.170=No-train+Anx\~Pos+Neut, No-train(all)\~50/50(all)≥ 0.136|Likelihood Ratio Tests|2=all df|=No-train+Neut\~Pos+Anx, 7.328=No-train+Neut\~Pos+Neut, 4.722=No-train+Anx\~Pos+Anx, 3.547=No-train+Anx\~Pos+Neut, No-train(all)\~50/50(all)≤3.988|Effect of CBM-I condition and Imagery Prime Type interaction: Each cell of the interaction was represented by one of 5 binary variables, set to 1 if a participant was in that group, and 0 otherwise; the sixth group (No-training + neutral prime) was considered a reference group, and was represented by all variables being 0. Due to high attrition, latent growth curve modeling was used instead of the planned approach. Because omnibus tests were not run, results for all comparisons are listed below.||||0.011
70931000|NCT02382003|141362006|SUPERIORITY||Mean Difference (Net)|11.551||||0.003|TWO_SIDED|||||"=Positive\~No-training, 0.130=Positive\~50/50 training, 0.269=50/50\~No-training~Alpha = .05"|Likelihood Ratio Tests|2=Positive\~No-training, 2=Positive\~50/50 training, 2=50/50\~No-training|=Positive\~No-training, 4.075=Positive\~50/50 training, 2.630=50/50\~No-training|Effect of CBM-I condition: The main effect of CBM-I was represented by three binary variables in the main effect models (Positive vs. No-training control; 50/50 vs. No- training control; Positive vs. 50/50). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||0.003
70931001|NCT02382003|141362006|SUPERIORITY||Mean Difference (Net)|3.933||||0.14|TWO_SIDED|||||Alpha = .05|Likelihood Ratio Tests|2=df Neutral\~Anxiety prime||Effect of Imagery Prime Type: The main effect of imagery prime was represented by one binary variable (neutral vs. anxiety imagery). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||0.140
70941570|NCT05135156|141383866|SUPERIORITY||Mean Difference (Net)|0.05||||0.91|TWO_SIDED|95.0|-0.84|0.94|||Regression, Linear||Parameters are for a 60-minute greater amount of time spent on the website (range was 21-418 minutes in the first 2 weeks).|Outcome = change in confidence-weighted true false knowledge about lung transplant (14-question investigator-designed survey) from baseline to 2-week study visit||0.94|-0.84|0.91
70941571|NCT05135156|141383866|SUPERIORITY||Mean Difference (Net)|0.04||||0.53|TWO_SIDED|95.0|-0.08|0.16|||Regression, Linear||Parameters are for a 60-minute greater amount of time spent on the website (range was 21-418 minutes in the first 2 weeks).|Outcome = change in Likert preparedness to discuss transplant from baseline to 2-week study visit||0.16|-0.08|0.53
71105110|NCT04887831|141717286|OTHER||Adjusted percentage difference|-0.101|STANDARD_ERROR_OF_MEAN|0.1052||0.34|TWO_SIDED|95.0|-0.308|0.105||The 2-sided p-value was calculated using stratified CMH method to account for the presence of visceral metastasis (yes/no) and initial chemotherapy type (cisplatin/carboplatin) as the stratification factors.|Cochran-Mantel-Haenszel|||||0.105|-0.308|0.340
71105111|NCT04887831|141717287|OTHER||Adjusted percentage difference|-0.008|STANDARD_ERROR_OF_MEAN|0.1078||0.938|TWO_SIDED|95.0|-0.22|0.203||The 2-sided p-value was calculated using stratified CMH method to account for the presence of visceral metastasis (yes/no) and initial chemotherapy type (cisplatin/carboplatin) as the stratification factors.|Cochran-Mantel-Haenszel|||||0.203|-0.220|0.938
70941572|NCT05135156|141383866|SUPERIORITY||Mean Difference (Net)|-4.3||||0.04|TWO_SIDED|95.0|-8.4|-0.3|||Regression, Linear||Parameters are for a 60-minute greater amount of time spent on the website (range was 21-418 minutes in the first 2 weeks).|Outcome = change in Decisional Conflict Scale from baseline to 2-week study visit||-0.3|-8.4|0.04
71016943|NCT03692078|141541628|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.452||||0.0014|TWO_SIDED|95.0|-0.775|-0.128|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.128|-0.775|0.0014
71016944|NCT03692078|141541628|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.475||||0.0007|TWO_SIDED|95.0|-0.799|-0.152|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.152|-0.799|0.0007
71016945|NCT03692078|141541628|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.76|||<|0.0001|TWO_SIDED|95.0|-3.127|-2.394|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.394|-3.127|<.0001
71016946|NCT03692078|141541628|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-2.902|||<|0.0001|TWO_SIDED|95.0|-3.271|-2.533|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.533|-3.271|<.0001
71016947|NCT03692078|141541628|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.804|||<|0.0001|TWO_SIDED|95.0|-3.165|-2.443|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.443|-3.165|<.0001
71016948|NCT03692078|141541628|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-2.952|||<|0.0001|TWO_SIDED|95.0|-3.317|-2.587|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.587|-3.317|<.0001
71016949|NCT03692078|141541628|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.066|||<|0.0001|TWO_SIDED|95.0|1.719|2.413|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||2.413|1.719|<.0001
71016950|NCT03692078|141541628|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.099|||<|0.0001|TWO_SIDED|95.0|1.748|2.449|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||2.449|1.748|<.0001
71016951|NCT03692078|141541628|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.129|||<|0.0001|TWO_SIDED|95.0|1.779|2.478|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||2.478|1.779|<.0001
71079481|NCT00482170|141666450|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.005|TWO_SIDED|95.0|1.17|2.41||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.41|1.17|0.005
71079482|NCT00482170|141666450|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.076|TWO_SIDED|95.0|0.97|2.03||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.03|0.97|0.076
71079483|NCT00482170|141666450|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.049|TWO_SIDED|95.0|1.0|2.11||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||2.11|1.00|0.049
71079484|NCT00482170|141666451|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93|||<|0.001|TWO_SIDED|95.0|1.32|2.83||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.83|1.32|<0.001
71079485|NCT00482170|141666451|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.63|||<|0.001|TWO_SIDED|95.0|1.78|3.87||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.87|1.78|<0.001
71079486|NCT00482170|141666451|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13|||<|0.001|TWO_SIDED|95.0|1.42|3.19||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.19|1.42|<0.001
71079487|NCT00482170|141666451|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.27|||<|0.001|TWO_SIDED|95.0|1.52|3.39||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||3.39|1.52|<0.001
71079488|NCT00482170|141666452|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.057|TWO_SIDED|95.0|0.99|2.11||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.11|0.99|0.057
71079489|NCT00482170|141666452|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.151|TWO_SIDED|95.0|0.9|1.96||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.96|0.90|0.151
71079490|NCT00482170|141666452|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.024|TWO_SIDED|95.0|1.06|2.44||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.44|1.06|0.024
71079491|NCT00482170|141666452|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.025|TWO_SIDED|95.0|1.06|2.39||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||2.39|1.06|0.025
71079492|NCT00482170|141666453|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.34|||<|0.001|TWO_SIDED|95.0|0.24|0.49||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.49|0.24|<0.001
71079493|NCT00482170|141666453|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.26|||<|0.001|TWO_SIDED|95.0|0.18|0.37||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.37|0.18|<0.001
71079494|NCT00482170|141666453|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.31|||<|0.001|TWO_SIDED|95.0|0.21|0.45||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.45|0.21|<0.001
71079495|NCT00482170|141666453|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32|||<|0.001|TWO_SIDED|95.0|0.23|0.47||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||0.47|0.23|<0.001
71016952|NCT03692078|141541628|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.107|||<|0.0001|TWO_SIDED|95.0|1.756|2.459|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||2.459|1.756|<.0001
71016953|NCT03692078|141541628|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.18||||0.7678|TWO_SIDED|95.0|-0.569|0.209|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.209|-0.569|0.7678
71016954|NCT03692078|141541628|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.319||||0.1691|TWO_SIDED|95.0|-0.711|0.073|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.073|-0.711|0.1691
71016955|NCT03692078|141541628|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.224||||0.5178|TWO_SIDED|95.0|-0.606|0.158|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.158|-0.606|0.5178
71016956|NCT03692078|141541628|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.369||||0.0699|TWO_SIDED|95.0|-0.757|0.018|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.018|-0.757|0.0699
71016957|NCT03692078|141541630|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|6.177|||<|0.0001|TWO_SIDED|95.0|6.062|6.292|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||6.292|6.062|<.0001
71016958|NCT03692078|141541630|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|6.197|||<|0.0001|TWO_SIDED|95.0|6.082|6.312|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||6.312|6.082|<.0001
71105112|NCT05093621|141717311|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Mortality at 1 year||||1.000
71105113|NCT05093621|141717312|SUPERIORITY|||||||0.729|||||||t-test, 2 sided|||||||0.729
71105114|NCT05093621|141717313|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|||||||0.650
71105115|NCT05093621|141717314|SUPERIORITY|||||||0.873|||||||t-test, 2 sided|||||||0.873
71105116|NCT01198587|141717420|SUPERIORITY|||||||0.88|||||||Log Rank|||||||0.88
71105117|NCT01198587|141717420|SUPERIORITY|||||||0.19|||||||Log Rank|||||||0.19
71105118|NCT02008617|141717463|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
70931002|NCT02382003|141362006|SUPERIORITY||Mean Difference (Net)|6.018||||0.049|TWO_SIDED|||||=No-train+Neut\~Pos+Anx,0.049=No-train+Neut\~Pos+Neut,Positive(all)\~No-train+Anx≥0.198,50/50(all)\~No-train+Anx≥0.104,0.014=No-train+Neut\~50/50+Neut,0.627=No-train+Neut\~50/50+Anx,0.021=Pos+Anx\~50/50+Anx,0.764=Pos+Anx\~50/50+Neut,Pos+Neut\~50/50(all)≥0.067|Likelihood Ratio Tests|2=all df|=No-train+Neut\~Pos+Anx,6.041=No-train+Neut\~Pos+Neut,Positive(all)\~No-train+Anx≤3.240,50/50(all)\~No-train+Anx≤4.534,8.525=No-train+Neut\~50/50+Neut,0.933=No-train+Neut\~50/50+Anx,7.686=Pos+Anx\~50/50+Anx,0.537=Pos+Anx\~50/50+Neut,Pos+Neut\~50/50(all)≤5.395|Effect of CBM-I condition and Imagery Prime Type interaction: Each cell of the interaction was represented by one of 5 binary variables, set to 1 if a participant was in that group, and 0 otherwise; the sixth group (No-training + neutral prime) was considered a reference group, and was represented by all variables being 0. Due to high attrition, latent growth curve modeling was used instead of the planned approach. Because omnibus tests were not run, results for all comparisons are listed below.||||0.049
71105119|NCT02008617|141717464|SUPERIORITY_OR_OTHER|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||At Rest||||0.86
70931003|NCT02382003|141362007|SUPERIORITY||Mean Difference (Net)|17.42|||<|0.001|TWO_SIDED|||||=Positive\~No-training, Positive\~50/50 training\<0.001, 0.124=50/50\~No-training Alpha = .05|Likelihood Ratio Tests|2=df Positive\~No-training, 2=df Positive\~50/50 training, 2=df 50/50\~No-training|=Positive\~No-training, 31.921=Positive\~50/50 training, 4.175=50/50\~No-training|Effect of CBM-I condition: The main effect of CBM-I was represented by three binary variables in the main effect models (Positive vs. No-training control; 50/50 vs. No- training control; Positive vs. 50/50). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||<0.001
70931004|NCT02382003|141362007|SUPERIORITY||Mean Difference (Net)|0.634||||0.728|TWO_SIDED|||||=Neutral\~Anxiety prime Alpha = .05|Likelihood Ratio Tests|2=df Neutral\~Anxiety prime|=Neutral\~Anxiety prime|Effect of Imagery Prime Type: The main effect of imagery prime was represented by one binary variable (neutral vs. anxiety imagery). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||0.728
70931005|NCT02382003|141362007|SUPERIORITY||Mean Difference (Net)|15.034|||<|0.001|TWO_SIDED|||||=Pos+Anx\~No-train+Neut, 0.026=Pos+Anx\~No-train+Anx, 0.002=Pos+Neut\~No-train+Neut, 0.091=Pos+Neut\~No-train+Anx, 50/50(all)\~No-train(all)≥ 0.081, Positive(all)\~50/50(all)\< 0.001|Likelihood Ratio Tests|2=all df|=Pos+Anx\~No-train+Neut, 7.306=Pos+Anx\~No-train+Anx, 12.672=Pos+Neut\~No-train+Neut, 4.802=Pos+Neut\~No-train+Anx, 50/50(all)\~No-train(all)≤5.037, Positive(all)\~50/50(all)≥16.239|Effect of CBM-I condition and Imagery Prime Type interaction: Each cell of the interaction was represented by one of 5 binary variables, set to 1 if a participant was in that group, and 0 otherwise; the sixth group (No-training + neutral prime) was considered a reference group, and was represented by all variables being 0. Due to high attrition, latent growth curve modeling was used instead of the planned approach. Because omnibus tests were not run, results for all comparisons are listed below.||||<0.001
70931006|NCT02382003|141362008|SUPERIORITY||Mean Difference (Net)|13.924|||<|0.001|TWO_SIDED|||||=Positive\~No-training, Positive\~50/50 training\< 0.001, 0.100=50/50\~No-training Alpha = .05|Likelihood Ratio Tests|2=df Positive\~No-training, 2=df Positive\~50/50 training, 2=df 50/50\~No-training|=Positive\~No-training, 15.288=Positive\~50/50 training, 4.605=50/50\~No-training|Effect of CBM-I condition: The main effect of CBM-I was represented by three binary variables in the main effect models (Positive vs. No-training control; 50/50 vs. No- training control; Positive vs. 50/50). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||< 0.001
70931007|NCT02382003|141362008|SUPERIORITY||Mean Difference (Net)|4.011||||0.135|TWO_SIDED|||||=Neutral\~Anxiety prime Alpha = .05|Likelihood Ratio Tests|2=df Neutral\~Anxiety prime|=Neutral\~Anxiety prime|Effect of Imagery Prime Type: The main effect of imagery prime was represented by one binary variable (neutral vs. anxiety imagery). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||0.135
71105120|NCT02008617|141717464|SUPERIORITY_OR_OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||Plantar Flexion||||0.89
71105121|NCT02008617|141717465|SUPERIORITY_OR_OTHER|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
71105122|NCT02008617|141717466|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.82
71105123|NCT02958865|141717508|SUPERIORITY||Mean Difference (Final Values)|-2.03|STANDARD_ERROR_OF_MEAN|0.69||0.0017|TWO_SIDED|90.0|-3.17|-0.89|||Constrained Longitudinal Data Analysis|||The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.||-0.89|-3.17|0.0017
71105124|NCT02958865|141717508|SUPERIORITY||Mean Difference (Final Values)|-3.88|STANDARD_ERROR_OF_MEAN|0.69|<|0.0001|TWO_SIDED|90.0|-5.01|-2.74|||Constrained Longitudinal Data Analysis|||The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.||-2.74|-5.01|< 0.0001
71105125|NCT02958865|141717508|SUPERIORITY||Mean Difference (Final Values)|-4.61|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|TWO_SIDED|90.0|-5.76|-3.46|||Constrained Longitudinal Data Analysis|||The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.||-3.46|-5.76|< 0.0001
71105126|NCT02958865|141717508|SUPERIORITY||Mean Difference (Final Values)|-1.79|STANDARD_ERROR_OF_MEAN|0.68||0.0045|TWO_SIDED|90.0|-2.92|-0.67|||Constrained Longitudinal Data Analysis|||The null hypothesis was that the there is no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm is declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect is below zero.||-0.67|-2.92|0.0045
71105127|NCT02958865|141717508|SUPERIORITY||Mean Difference (Final Values)|-2.28|STANDARD_ERROR_OF_MEAN|0.69||0.0005|TWO_SIDED|90.0|-3.41|-1.14|||Constrained Longitudinal Data Analysis|||The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.||-1.14|-3.41|0.0005
71105128|NCT02958865|141717508|SUPERIORITY||Mean Difference (Final Values)|-3.21|STANDARD_ERROR_OF_MEAN|0.69|<|0.0001|TWO_SIDED|90.0|-4.34|-2.08|||Constrained Longitudinal Data Analysis|||The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.||-2.08|-4.34|< 0.0001
71105129|NCT02958865|141717525|SUPERIORITY||Mean Difference (Final Values)|9.8||||0.0626|TWO_SIDED|90.0|-1.0|19.5|||Chan and Zhang method|||||19.5|-1.0|0.0626
70931008|NCT02382003|141362008|SUPERIORITY||Mean Difference (Net)|9.402||||0.009|TWO_SIDED|||||=Pos+Anx\~No-train+Neut, Pos+Anx\~No-train+Anx\<0.048, Pos+Neut\~No-train+Neut\<0.001, 0.055=Pos+Neut\~No-train+Anx, 50/50(all)\~No-train+Anx≥0.139, 0.034=No-train+Neut\~50/50+Neut, 0.340=No-train+Neut\~50/50+Anx, Pos(all)\~50/50(all)≥ 0.087|Likelihood Ratio Tests|2=all df|=Pos+Anx\~No-train+Neut, 6.076=Pos+Anx\~No-train+Anx, 14.525=Pos+Neut\~No-train+Neut, 5.811=Pos+Neut\~No-train+Anx, 50/50(all)\~No-train+Anx≤3.950, 6.770=No-train+Neut\~50/50+Neut, 2.158=No-train+Neut\~50/50+Anx, Pos(all)\~50/50(all)≤4.876|Effect of CBM-I condition and Imagery Prime Type interaction: Each cell of the interaction was represented by one of 5 binary variables, set to 1 if a participant was in that group, and 0 otherwise; the sixth group (No-training + neutral prime) was considered a reference group, and was represented by all variables being 0. Due to high attrition, latent growth curve modeling was used instead of the planned approach. Because omnibus tests were not run, results for all comparisons are listed below.||||0.009
70931009|NCT04479787|141362013|OTHER||||||<|0.0001|||||||Two-sided Z-Test|||||||<0.0001
70931010|NCT04479787|141362014|OTHER||||||<|0.0001|||||||Two-sided Z-Test|||||||< 0.0001
70931011|NCT04479787|141362015|OTHER||||||<|0.0001|||||||Two-sample t-test.|||||||<0.0001
70931012|NCT04479787|141362016|OTHER||||||<|0.0001|||||||Two-sample t-test.|||||||<0.0001
70931013|NCT04479787|141362017|OTHER||||||<|0.0001|||||||Two-sided Z-Test|||||||<0.0001
70931014|NCT04479787|141362018|OTHER||||||<|0.0001|||||||Two-sided Z-Test|||||||<0.0001
70931015|NCT04479787|141362019|OTHER||||||<|0.0001|||||||Two-sample t-test.|||||||<0.0001
70931016|NCT04479787|141362020|OTHER||||||<|0.0001|||||||Two-sample t-test.|||||||<0.0001
70931017|NCT02379351|141362025|OTHER|This pilot study is primarily descriptive statistics||||||0.1|||||||Chi-squared|Data analysis will use mostly descriptive statistics - parametric and nonparametric statistics will be used as indicated (Chi-squared)||||||.1
70931018|NCT02379351|141362026|NON_INFERIORITY|Likert Scale of Provider Satisfaction|||||<|0.01|||||||Chi-squared|Data analysis will use mostly descriptive statistics: parametric and nonparametric statistics will be used as indicated.|||Likert Scale of Provider Satisfaction|||<0.01
70931019|NCT03373916|141362033|OTHER|||||||0.58|||||||Chi-squared|||||||0.58
70931020|NCT03373916|141362034|OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
70931021|NCT03373916|141362035|OTHER|||||||0.18|||||||Chi-squared|||||||0.18
71105130|NCT02958865|141717525|SUPERIORITY||Mean Difference (Final Values)|28.6||||0.0027|TWO_SIDED|90.0|13.9|41.0|||Chan and Zhang method|||||41.0|13.9|0.0027
70931022|NCT03373916|141362036|OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
70931023|NCT03373916|141362037|OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.35
70931024|NCT05288348|141362098|SUPERIORITY||Mean Difference (Final Values)|2.57||||0.56|TWO_SIDED|95.0|-6.19|11.33||unadjusted|Mixed Models Analysis|Mixed methods ANOVA||||11.33|-6.19|0.56
70931025|NCT05288348|141362098|SUPERIORITY||Mean Difference (Final Values)|-0.51||||0.92|TWO_SIDED|95.0|-10.5|9.48|||Mixed Models Analysis|Mixed methods ANOVA||Adjusted for age, sex, respiratory rate and injury type||9.48|-10.5|0.92
70931026|NCT05288348|141362099|SUPERIORITY||Mean Difference (Final Values)|-7.14||||0.18|TWO_SIDED|95.0|-17.66|3.37|||Mixed Models Analysis|Mixed effects ANOVA||VNRS @ 60min||3.37|-17.66|0.18
70931027|NCT05288348|141362099|SUPERIORITY||Median Difference (Final Values)|2.92||||0.63|TWO_SIDED|95.0|-9.3|15.1|||Mixed Models Analysis|Mixed effects ANOVA||VNRS @ 60 min Adjusted for sex and injury type||15.10|-9.30|0.63
70931028|NCT05288348|141362099|SUPERIORITY||Mean Difference (Final Values)|-10.59||||0.08|TWO_SIDED|95.0|-22.39|1.21||Unadjusted|Mixed Models Analysis|||VNRS @ 90 min||1.21|-22.39|0.08
70931029|NCT05288348|141362099|SUPERIORITY||Mean Difference (Final Values)|7.36||||0.28|TWO_SIDED|95.0|-6.13|20.8|||Mixed Models Analysis|Mixed Method ANOVA|Adjusted for ISS|VNRS @90min adjusted||20.80|-6.13|0.28
70931030|NCT05288348|141362099|SUPERIORITY||Mean Difference (Final Values)|-9.52||||0.18|TWO_SIDED|95.0|-23.6|4.56|||Mixed Models Analysis|||VNRS @ 120 min||4.56|-23.60|0.18
70931031|NCT05288348|141362099|SUPERIORITY||Mean Difference (Final Values)|-5.24||||0.5|TWO_SIDED|95.0|-20.7|10.2|||Mixed Models Analysis|Mixed Method ANOVA||VNRS @ 120min adjusted for sex, HR, RR, and injury type||10.20|-20.70|0.50
70931032|NCT05288348|141362100|SUPERIORITY|||||||0.005||||||PGA @ 30 min|Chi-squared|||||||0.005
70931033|NCT05288348|141362101|SUPERIORITY||Odds Ratio (OR)|1.45||||0.39|TWO_SIDED|95.0|-4.77|1.89|||General Addative Model|||"SPID 30~last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value"||1.89|-4.77|0.39
70931034|NCT05288348|141362101|SUPERIORITY||Odds Ratio (OR)|1.72||||0.29|TWO_SIDED|95.0|-1.5|4.95|||General Additive Model|||"SPID 30, Adjusted Analysis~last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value"||4.95|-1.50|0.29
70931035|NCT05288348|141362101|SUPERIORITY||Odds Ratio (OR)|0.08||||0.98|TWO_SIDED|95.0|-6.63|6.47|||Generalized Additive Model|||SPID @ 60min last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value||6.47|-6.63|0.98
70931036|NCT05288348|141362101|SUPERIORITY||Odds Ratio (OR)|0.61||||0.85|TWO_SIDED|95.0|-5.76|6.98|||Generalized Additive Model|||"SPID 60 Adjusted~Last observed carried forward to address missingness"||6.98|-5.76|0.85
70931037|NCT05288348|141362101|SUPERIORITY||Odds Ratio (OR)|-1.26||||0.8|TWO_SIDED|95.0|-8.75|11.28|||Generalized Additive Model|||SPID @ 90 mn last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value||11.28|-8.75|0.8
70931038|NCT05288348|141362101|SUPERIORITY||Odds Ratio (OR)|-0.44||||0.92|TWO_SIDED|95.0|-10.2|9.92|||Generalized Additive Model|||"SPID 90 min Adjusted~last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value"||9.92|-10.2|0.92
70931039|NCT05288348|141362101|SUPERIORITY||Odds Ratio (OR)|-3.18||||0.64|TWO_SIDED|95.0|-10.45|16.9|||Generalized Additive Model|||SPID @ 120 min last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value||16.90|-10.45|0.64
70931040|NCT05288348|141362101|SUPERIORITY||Odds Ratio (OR)|-2.15||||0.75|TWO_SIDED|95.0|-15.6|11.3|||Generalized Additive Model|||"SPID 120 Adjusted~last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value"||11.30|-15.60|0.75
70931041|NCT05288348|141362102|SUPERIORITY||z statistic|0.46||||0.64|TWO_SIDED|95.0|-1.96|1.96|||two sided test of proportion|||||1.96|-1.96|0.64
71016959|NCT03692078|141541630|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.798|||<|0.0001|TWO_SIDED|95.0|5.69|5.906|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||5.906|5.690|<.0001
71016960|NCT03692078|141541630|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|5.82|||<|0.0001|TWO_SIDED|95.0|5.71|5.93|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||5.930|5.710|<.0001
71016961|NCT03692078|141541630|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.863|||<|0.0001|TWO_SIDED|95.0|5.753|5.974|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||5.974|5.753|<.0001
71016962|NCT03692078|141541630|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|5.816|||<|0.0001|TWO_SIDED|95.0|5.706|5.927|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||5.927|5.706|<.0001
71016963|NCT03692078|141541630|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.947|||<|0.0001|TWO_SIDED|95.0|4.809|5.084|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||5.084|4.809|<.0001
71016964|NCT03692078|141541630|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.913|||<|0.0001|TWO_SIDED|95.0|4.774|5.052|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||5.052|4.774|<.0001
71016965|NCT03692078|141541630|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.862|||<|0.0001|TWO_SIDED|95.0|4.727|4.998|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||4.998|4.727|<.0001
71016966|NCT03692078|141541630|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.938|||<|0.0001|TWO_SIDED|95.0|4.799|5.076|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||5.076|4.799|<.0001
71016967|NCT03692078|141541630|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.826|||<|0.0001|TWO_SIDED|95.0|4.693|4.959|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||4.959|4.693|<.0001
71105131|NCT02958865|141717525|SUPERIORITY||Mean Difference (Final Values)|34.0||||0.001|TWO_SIDED|90.0|20.2|46.5|||Chan and Zhang Method|||||46.5|20.2|0.0010
71105132|NCT02958865|141717525|SUPERIORITY||Mean Difference (Final Values)|8.3||||0.0774|TWO_SIDED|90.0|-4.0|18.1|||Chan and Zhang method|||||18.1|-4.0|0.0774
71016968|NCT03692078|141541630|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.902|||<|0.0001|TWO_SIDED|95.0|4.767|5.037|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||5.037|4.767|<.0001
71016969|NCT03692078|141541630|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.379|||<|0.0001|TWO_SIDED|95.0|-0.602|-0.156|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.156|-0.602|<.0001
71016970|NCT03692078|141541630|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.376|||<|0.0001|TWO_SIDED|95.0|-0.601|-0.152|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.152|-0.601|<.0001
71016971|NCT03692078|141541630|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.314||||0.0014|TWO_SIDED|95.0|-0.537|-0.09|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.090|-0.537|0.0014
71050680|NCT00546572|141608004|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.4|||||TWO_SIDED|95.0|1.1|1.76|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 1: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.76|1.10|
71050681|NCT00546572|141608004|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.1|||||TWO_SIDED|95.0|0.91|1.34|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 3: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.34|0.91|
70931042|NCT05288348|141362103|SUPERIORITY||Odds Ratio (OR)|-0.22||||0.61|TWO_SIDED|95.0|-1.11|0.66|||General Additive Models|||||0.66|-1.11|0.61
71105133|NCT02958865|141717525|SUPERIORITY||Mean Difference (Final Values)|23.4||||0.0055|TWO_SIDED|90.0|8.2|35.8|||Chan and Zhang method|||||35.8|8.2|0.0055
70931043|NCT05288348|141362103|SUPERIORITY||Odds Ratio (OR)|-0.28||||0.54|TWO_SIDED|95.0|-1.23|0.65|||General Additive Model|||6 item screener adjusted analysis||0.65|-1.23|0.54
70931044|NCT05288348|141362104|SUPERIORITY||Odds Ratio (OR)|2.35||||0.009|TWO_SIDED|95.0|1.24|4.46|||Ordinal Polytomous Logisitic Regression|||Healthcare Professional Global Assessment of method of pain control at 30 min.||4.46|1.24|0.009
71105134|NCT02958865|141717525|SUPERIORITY||Mean Difference (Final Values)|23.4||||0.0055|TWO_SIDED|90.0|8.2|35.8|||Chan and Zhang method|||||35.8|8.2|0.0055
71105135|NCT02958865|141717526|SUPERIORITY||Mean Difference (Final Values)|21.6||||0.0111|TWO_SIDED|90.0|5.6|33.2|||Chan and Zhang method|||||33.2|5.6|0.0111
70931045|NCT05288348|141362104|SUPERIORITY||Odds Ratio (OR)|2.24||||0.01|TWO_SIDED|95.0|1.18|4.29|||Ordinal polytomous logistic regression|||Healthcare Professional Global Assessment of method of pain control at 30 min. adjusted for ISS and Race||4.29|1.18|0.01
70931046|NCT05288348|141362105|SUPERIORITY||Odds Ratio (OR)|0.97||||0.96|TWO_SIDED|95.0|0.22|4.26|||Regression, Logistic|||||4.26|0.22|0.96
70931047|NCT05288348|141362105|SUPERIORITY||Odds Ratio (OR)|0.94|||||TWO_SIDED|95.0|0.17|5.04|||||Adjusted for age, sex and SpO2|||5.04|0.17|
70931048|NCT05288348|141362106|SUPERIORITY||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.04|24.92||||||||24.92|0.04|
70931049|NCT05288348|141362106|SUPERIORITY||Odds Ratio (OR)|0.2|||||TWO_SIDED|95.0|0.0|14.28|||||Adjusted for Heart Rate and Injury Severity Score|||14.28|0|
70931050|NCT05288348|141362107|SUPERIORITY||Odds Ratio (OR)|1.67|||||TWO_SIDED|95.0|0.39|8.37||||||||8.37|0.39|
70931051|NCT05288348|141362107|SUPERIORITY||Odds Ratio (OR)|1.68|||||TWO_SIDED|95.0|0.39|8.6|||||Adjusted for SpO2|||8.60|0.39|
70931052|NCT05288348|141362109|SUPERIORITY||Odds Ratio (OR)|0.48|||||TWO_SIDED|95.0|0.02|5.12||||||||5.12|0.02|
70931053|NCT05288348|141362109|SUPERIORITY||Odds Ratio (OR)|0.41|||||TWO_SIDED|95.0|0.02|4.56|||||Adjusted for heart rate|||4.56|0.02|
70931054|NCT05288348|141362110|SUPERIORITY||difference of proportion|0.135|||>|0.99|TWO_SIDED||||||Chi-squared|||||||>0.99
70931055|NCT05288348|141362111|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.9|TWO_SIDED|95.0|0.69|1.61|||Regression, Cox|||||1.61|0.69|0.90
70931056|NCT05288348|141362111|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.48|TWO_SIDED|95.0|0.75|1.81|||Regression, Cox|||Adjusted for Race and ISS||1.81|0.75|0.48
71105136|NCT02958865|141717526|SUPERIORITY||Mean Difference (Final Values)|34.7||||0.0006|TWO_SIDED|90.0|20.2|47.4|||Chan and Zhang method|||||47.4|20.2|0.0006
71105137|NCT02958865|141717526|SUPERIORITY||Mean Difference (Final Values)|42.0||||0.0001|TWO_SIDED|90.0|29.5|54.6|||Chan and Zhang Method|||||54.6|29.5|0.0001
71016972|NCT03692078|141541630|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.381|||<|0.0001|TWO_SIDED|95.0|-0.604|-0.157|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.157|-0.604|<.0001
71016973|NCT03692078|141541630|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.23|||<|0.0001|TWO_SIDED|95.0|-1.484|-0.977|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.977|-1.484|<.0001
71016974|NCT03692078|141541630|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.284|||<|0.0001|TWO_SIDED|95.0|-1.539|-1.029|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.029|-1.539|<.0001
71016975|NCT03692078|141541630|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.315|||<|0.0001|TWO_SIDED|95.0|-1.564|-1.065|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.065|-1.564|<.0001
71016976|NCT03692078|141541630|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.259|||<|0.0001|TWO_SIDED|95.0|-1.512|-1.006|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.006|-1.512|<.0001
71016977|NCT03692078|141541630|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.972|||<|0.0001|TWO_SIDED|95.0|0.732|1.211|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.211|0.732|<.0001
71016978|NCT03692078|141541630|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.918|||<|0.0001|TWO_SIDED|95.0|0.676|1.161|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.161|0.676|<.0001
71105138|NCT02958865|141717526|SUPERIORITY||Mean Difference (Final Values)|20.8||||0.0101|TWO_SIDED|90.0|5.6|33.0|||Chan and Zhang method|||||33.0|5.6|0.0101
71105139|NCT02958865|141717526|SUPERIORITY||Mean Difference (Final Values)|31.9||||0.0014|TWO_SIDED|90.0|17.0|44.8|||Chan and Zhang method|||||44.8|17.0|0.0014
71105140|NCT02958865|141717526|SUPERIORITY||Mean Difference (Final Values)|29.8||||0.0015|TWO_SIDED|90.0|17.0|42.6|||Chan and Zhang method|||||42.6|17.0|0.0015
71105141|NCT02958865|141717527|SUPERIORITY||Mean Difference (Final Values)|17.2||||0.0788|TWO_SIDED|90.0|-3.4|34.4|||Chan and Zhang method|||||34.4|-3.4|0.0788
71105142|NCT02958865|141717527|SUPERIORITY||Mean Difference (Final Values)|45.4||||0.0002|TWO_SIDED|90.0|23.6|62.1|||Chan and Zhang method|||||62.1|23.6|0.0002
71105143|NCT02958865|141717527|SUPERIORITY||Mean Difference (Final Values)|44.0||||0.0003|TWO_SIDED|90.0|23.5|60.5|||Chan and Zhang Method|||||60.5|23.5|0.0003
70931057|NCT05288348|141362113|SUPERIORITY||Odds Ratio (OR)|0.0||||0.99|TWO_SIDED|95.0|-0.15|0.15|||Non parametric General Addative Model|||||0.15|-0.15|0.99
71105144|NCT02958865|141717527|SUPERIORITY||Mean Difference (Final Values)|17.7||||0.0773|TWO_SIDED|90.0|-4.0|35.1|||Chan and Zhang method|||||35.1|-4.0|0.0773
70850841|NCT03023813|141189754|OTHER|Receipt of colorectal cancer screening since the baseline encounter|Odds Ratio (OR)|2.52||||0.99|TWO_SIDED|95.0|0.001|1000.0|||Mixed Models Analysis|Generalized linear mixed regression with logit link|Result for intervention arm relative to control arm. Lower limit estimate was \<0.001 and upper limit estimate was \>1000 (ClinicalTrials.gov does not allow \< or \> to be entered into the confidence interval lower limit or upper limit fields).|Among participants whose individualized preventive care recommendations included colorectal cancer screening||1000|0.001|0.99
70850842|NCT02433080|141189757|OTHER||Mean Difference (Net)|6.4||||0.05|TWO_SIDED|95.0|-3.6|16.5|||ANCOVA|||This statistical analysis applies for the outcomes 2-8.||16.5|-3.6|0.05
70850843|NCT04530136|141189768|SUPERIORITY|||||||0.0346|||||||Wilcoxon rank test|||||||0.0346
70850844|NCT04530136|141189769|SUPERIORITY|||||||0.4441|||||||WHO Ordinal Scale|||||||0.4441
70850845|NCT04530136|141189770|SUPERIORITY|||||||0.1021|||||||WHO Ordinal Scale for Clin Improvement|||||||0.1021
70850846|NCT04530136|141189771|SUPERIORITY|||||||0.1615|||||||WHO Ordinal Scale|||||||0.1615
70850847|NCT01309282|141189772|SUPERIORITY_OR_OTHER|||||||0.0078|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0078
70850848|NCT01309282|141189773|SUPERIORITY_OR_OTHER|||||||0.0078|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0078
70850849|NCT01309282|141189774|SUPERIORITY_OR_OTHER|||||||0.01403|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.01403
70850850|NCT01309282|141189775|SUPERIORITY_OR_OTHER|||||||0.0355|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0355
70850851|NCT01309282|141189776|SUPERIORITY_OR_OTHER|||||||0.5469|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.5469
70850852|NCT01309282|141189777|SUPERIORITY_OR_OTHER|||||||0.0225|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0225
70850853|NCT01309282|141189778|SUPERIORITY_OR_OTHER|||||||0.0225|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0225
70850854|NCT01309282|141189779|SUPERIORITY_OR_OTHER|||||||0.0904|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0904
70850855|NCT01309282|141189780|SUPERIORITY_OR_OTHER|||||||0.2969|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.2969
70850856|NCT01387542|141189786|SUPERIORITY_OR_OTHER|||||||0|||||||Friedman test|||||||0.000
70850857|NCT01387542|141189787|SUPERIORITY_OR_OTHER|||||||0.009|||||||Paired t-test|||||||0.009
70850858|NCT01387542|141189788|SUPERIORITY_OR_OTHER|||||||0.001|||||||Paired t-test|||||||0.001
70850859|NCT01387542|141189789|SUPERIORITY_OR_OTHER|||||||0|||||||Paired t-test|||||||0.000
70850860|NCT03601117|141189790|OTHER|This is to test for the antidepressant effect of LDLPFC stimulation. Test is change in score from baseline to approximately 48 hours after the final session.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<.001
70850861|NCT00884741|141189824|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.13||||0.11|TWO_SIDED|95.0|0.93|1.37||To control for type I error in testing the co-primary endpoints, the significance criterion for OS was 0.023 (one-sided) and for PFS was 0.002 (one-sided).|Log Rank|||The trial was designed to concurrently provide 80% power for the detection of a 25% relative reduction in mortality hazard (hazard ratio .75) and 30% reduction in progression hazard (hazard ratio .70) for the addition of bevacizumab to temozolomide and radiation. To control for type I error in testing the co-primary endpoints, the significance criterion for OS was 0.023 (one-sided) and for PFS was 0.002 (one-sided).||1.37|0.93|0.11
70850862|NCT00884741|141189825|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.79||||0.004|TWO_SIDED|95.0|0.66|0.94||To control for type I error in testing the co-primary endpoints, the significance criterion for OS was 0.023 (one-sided) and for PFS was 0.002 (one-sided).|Log Rank|||The trial was designed to concurrently provide 80% power for the detection of a 25% relative reduction in mortality hazard (hazard ratio .75) and 30% reduction in progression hazard (hazard ratio .70) for the addition of bevacizumab to temozolomide and radiation. To control for type I error in testing the co-primary endpoints, the significance criterion for OS was 0.023 (one-sided) and for PFS was 0.002 (one-sided).||0.94|0.66|0.004
70850863|NCT00884741|141189826|SUPERIORITY_OR_OTHER|||||||0.42||||||Two-sided|Chi-squared|||||||0.42
70850864|NCT02762370|141189846|SUPERIORITY|||||||0.0452|||||||t-test, 2 sided|||||||0.0452
70850865|NCT00101452|141189858|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
70850866|NCT05661851|141189861|NON_INFERIORITY|Non-inferiority margin of -20 was used.|Least-square Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|3.79|||TWO_SIDED|95.0|-1.67|13.38|||Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|LS Mean difference was calculated as Test minus Control.|A sample size of 104 subjects provides at least 90% statistical power to test non-inferiority of the Test eyedrop compared to the Control eyedrop using a two sample t-test with a two-sided type I error rate of 0.05.||13.38|-1.67|
70850867|NCT05661851|141189862|NON_INFERIORITY|Non-inferiority margin of -20 was used.|Mean Population Difference Estimate|5.843|STANDARD_ERROR_OF_MEAN|4.456|||TWO_SIDED|95.0|-2.8904|14.5768|||Bootstrapping methods||Bootstrap Mean Difference was calculated as Test minus Control|A sample size of 104 subjects provides at least 90% statistical power to test non-inferiority of the Test eyedrop compared to the Control eyedrop using a two sample t-test with a two-sided type I error rate of 0.05.||14.5768|-2.8904|
70850868|NCT01014910|141189863|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|||||Based on a previously-identified mean LOS of 65.3 hours, we estimated we would need to enroll 80 patients in each study arm to provide adequate sample size to detect a difference in mean LOS of 18 hours with 80% power and alpha=0.05.|Wilcoxon (Mann-Whitney)|Sample size calculations were performed using Power and Sample Size Calculator, version 3.0 (by developers William D. Dupont and Walton D. Plummer Jr)||Differences in LOS were compared between study arms using the Mann-Whitney U-test and the Kaplan-Meier method. Statistical analyses were performed using Stata version 13.1 for Windows (StataCorp). All patients enrolled in the study, including those who subsequently had consent for the intervention withdrawn, were included for analysis (intention to treat).||||<0.05
70850869|NCT01014910|141189864|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||Chi-squared, Corrected|||The proportion of patients transferred to the intensive care unit in each study arm was compared between study arms using the Pearson χ2 test. All patients enrolled in the study, including those who subsequently had consent for the intervention withdrawn, were included for analysis (intention to treat).||||0.05
71105145|NCT02958865|141717527|SUPERIORITY||Mean Difference (Final Values)|29.2||||0.0136|TWO_SIDED|90.0|5.6|47.0|||Chan and Zhang method|||||47.0|5.6|0.0136
71016979|NCT03692078|141541630|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|1.037|||<|0.0001|TWO_SIDED|95.0|0.797|1.278|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.278|0.797|<.0001
71016980|NCT03692078|141541630|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.914|||<|0.0001|TWO_SIDED|95.0|0.672|1.156|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.156|0.672|<.0001
71016981|NCT03692078|141541630|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.121||||0.7939|TWO_SIDED|95.0|-0.147|0.388|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.388|-0.147|0.7939
71016982|NCT03692078|141541630|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.011||||1|TWO_SIDED|95.0|-0.26|0.281|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.281|-0.260|1.0000
71016983|NCT03692078|141541630|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.036||||1|TWO_SIDED|95.0|-0.228|0.301|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.301|-0.228|1.0000
71016984|NCT03692078|141541630|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.036||||1|TWO_SIDED|95.0|-0.233|0.305|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.305|-0.233|1.0000
71016985|NCT03692078|141541632|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|7.367|||<|0.0001|TWO_SIDED|95.0|7.25|7.485|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||7.485|7.250|<.0001
71016986|NCT03692078|141541632|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|7.368|||<|0.0001|TWO_SIDED|95.0|7.251|7.485|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||7.485|7.251|<.0001
71105146|NCT02958865|141717527|SUPERIORITY||Mean Difference (Final Values)|37.7||||0.0015|TWO_SIDED|90.0|13.9|54.7|||Chan and Zhang method|||||54.7|13.9|0.0015
71105147|NCT02958865|141717528|SUPERIORITY||Mean Difference (Final Values)|3.9||||0.2259|TWO_SIDED|90.0|-6.5|11.8|||Chan and Zhang method|||||11.8|-6.5|0.2259
71105148|NCT02958865|141717528|SUPERIORITY||Mean Difference (Final Values)|8.2||||0.082|TWO_SIDED|90.0|-3.8|17.7|||Chan and Zhang method|||||17.7|-3.8|0.0820
71105149|NCT02958865|141717528|SUPERIORITY||Mean Difference (Final Values)|12.0||||0.0649|TWO_SIDED|90.0|-0.7|22.3|||Chan and Zhang Method|||||22.3|-0.7|0.0649
71105150|NCT02958865|141717528|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.3777|TWO_SIDED|90.0|-8.6|9.7|||Chan and Zhang method|||||9.7|-8.6|0.3777
71105151|NCT02958865|141717528|SUPERIORITY||Mean Difference (Final Values)|17.0||||0.0212|TWO_SIDED|90.0|2.9|28.6|||Chan and Zhang method|||||28.6|2.9|0.0212
71105152|NCT02958865|141717528|SUPERIORITY||Mean Difference (Final Values)|8.5||||0.0742|TWO_SIDED|90.0|-4.2|18.4|||Chan and Zhang method|||||18.4|-4.2|0.0742
70931058|NCT05288348|141362113|SUPERIORITY||Odds Ratio (OR)|0.01||||0.96|TWO_SIDED|95.0|-0.16|0.15|||Non Parametric General Additive Model|||Adjusted||0.15|-0.16|0.96
70931059|NCT05288348|141362114|SUPERIORITY||Odds Ratio (OR)|0.01||||0.84|TWO_SIDED|95.0|-0.17|0.16|||Non Parametric General Additive Model|||||0.16|-0.17|0.84
70931060|NCT05288348|141362114|SUPERIORITY||Odds Ratio (OR)|0.02||||0.84|TWO_SIDED|95.0|-0.19|0.16|||Non Parametric Generalized Additive Mode|||Adjusted||0.16|-0.19|0.84
70931061|NCT05288348|141362115|SUPERIORITY||Odds Ratio (OR)|0.02||||0.81|TWO_SIDED|95.0|-0.17|0.22|||Non Parametric Generalized Additive Mode|||||0.22|-0.17|0.81
70931062|NCT05288348|141362115|SUPERIORITY||Odds Ratio (OR)|0.01||||0.91|TWO_SIDED|95.0|-0.2|0.22|||Non Parametric Generalized Additive Mode|||Adjusted||0.22|-0.20|0.91
70931063|NCT05288348|141362116|SUPERIORITY||Odds Ratio (OR)|0.03||||0.74|TWO_SIDED|95.0|-0.25|0.18|||Non Parametric Generalized Additive Mode|||||0.18|-0.25|0.74
70931064|NCT05288348|141362116|SUPERIORITY||Odds Ratio (OR)|0.05||||0.63|TWO_SIDED|95.0|-0.3|0.18|||Non Parametric Generalized Additive Mode|||Adjusted||0.18|-0.30|0.63
70931065|NCT03213457|141362117|SUPERIORITY||Odds Ratio (OR)|5.51|||<|0.001|TWO_SIDED|95.0|3.711|8.176||P-value for test of difference is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||8.176|3.711|< 0.001
70931066|NCT03213457|141362117|SUPERIORITY||Odds Ratio (OR)|4.33|||<|0.001|TWO_SIDED|95.0|2.968|6.331||P-value for test of difference is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 12||6.331|2.968|< 0.001
70931067|NCT03213457|141362118|SUPERIORITY||Odds Ratio (OR)|1.82|||<|0.001|TWO_SIDED|95.0|1.275|2.605||P-value for test of difference is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||2.605|1.275|< 0.001
71105153|NCT02958865|141717529|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.0872|TWO_SIDED|90.0|-3.4|17.1|||Chan and Zhang method|||||17.1|-3.4|0.0872
71105154|NCT02958865|141717529|SUPERIORITY||Mean Difference (Final Values)|16.3||||0.0254|TWO_SIDED|90.0|3.0|27.5|||Chan and Zhang method|||||27.5|3.0|0.0254
70931068|NCT03213457|141362118|SUPERIORITY||Odds Ratio (OR)|1.63||||0.007|TWO_SIDED|95.0|1.146|2.326||P-value for test of difference is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 12||2.326|1.146|0.007
70931069|NCT03213457|141362119|SUPERIORITY||Least Squares (LS) Mean of Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.094|<|0.001|TWO_SIDED|95.0|-1.18|-0.809||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|mixed model repeated measures (MMRM)|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.809|-1.180|< 0.001
70931070|NCT03213457|141362120|SUPERIORITY||LS Mean of Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.088|<|0.001|TWO_SIDED|95.0|-1.19|-0.845||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.845|-1.190|< 0.001
70931071|NCT03213457|141362121|SUPERIORITY||LS Mean of Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.085|<|0.001|TWO_SIDED|95.0|-1.156|-0.823||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.823|-1.156|< 0.001
70931072|NCT03213457|141362122|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.073||0.002|TWO_SIDED|95.0|-0.367|-0.08||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.080|-0.367|0.002
71105155|NCT02958865|141717529|SUPERIORITY||Mean Difference (Final Values)|26.0||||0.0034|TWO_SIDED|90.0|11.0|38.1|||Chan and Zhang Method|||||38.1|11.0|0.0034
71105156|NCT02958865|141717529|SUPERIORITY||Mean Difference (Final Values)|6.3||||0.1565|TWO_SIDED|90.0|-4.5|15.4|||Chan and Zhang method|||||15.4|-4.5|0.1565
71105157|NCT02958865|141717529|SUPERIORITY||Mean Difference (Final Values)|14.9||||0.0288|TWO_SIDED|90.0|1.7|26.2|||Chan and Zhang method|||||26.2|1.7|0.0288
71105158|NCT02958865|141717529|SUPERIORITY||Mean Difference (Final Values)|14.9||||0.0288|TWO_SIDED|90.0|1.7|26.2|||Chan and Zhang method|||||26.2|1.7|0.0288
71105159|NCT02958865|141717530|SUPERIORITY||Mean Difference (Final Values)|3.9||||0.2259|TWO_SIDED|90.0|-6.5|11.8|||Chan and Zhang method|||||11.8|-6.5|0.2259
71105160|NCT02958865|141717530|SUPERIORITY||Mean Difference (Final Values)|8.2||||0.082|TWO_SIDED|90.0|-3.8|17.7|||Chan and Zhang method|||||17.7|-3.8|0.0820
70931073|NCT03213457|141362123|SUPERIORITY||LS Mean of Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.062|<|0.001|TWO_SIDED|95.0|-0.329|-0.085||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.085|-0.329|< 0.001
70931074|NCT03213457|141362124|SUPERIORITY||LS Mean of Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.056||0.004|TWO_SIDED|95.0|-0.27|-0.05||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.050|-0.270|0.004
70931075|NCT03213457|141362125|SUPERIORITY||LS Mean of Difference|-2.51|STANDARD_ERROR_OF_MEAN|0.9||0.005|TWO_SIDED|95.0|-4.283|-0.746||P-value for test of difference at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.746|-4.283|0.005
70931076|NCT03213457|141362126|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.098||0.284|TWO_SIDED|95.0|-0.298|0.088||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||0.088|-0.298|0.284
70931077|NCT03213457|141362127|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.092||0.286|TWO_SIDED|95.0|-0.279|0.083||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||0.083|-0.279|0.286
70931078|NCT03213457|141362128|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.079||0.005|TWO_SIDED|95.0|-0.375|-0.066||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.066|-0.375|0.005
70931079|NCT03213457|141362129|SUPERIORITY||LS Mean of Difference|-2.49|STANDARD_ERROR_OF_MEAN|1.158||0.032|TWO_SIDED|95.0|-4.773|-0.216||P-value for test of difference at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.216|-4.773|0.032
70941573|NCT05135156|141383866|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.74|TWO_SIDED|95.0|-3.6|5.0||Outcome = mean PrepDM Scale at 2-weeks|Regression, Linear||Parameters are for a 60-minute greater amount of time spent on the website (range was 21-418 minutes in the first 2 weeks).|||5.0|-3.6|0.74
70941574|NCT02402465|141383880|SUPERIORITY||Mean Difference (Final Values)|37.0|||>|0.05|TWO_SIDED||||||ANOVA||Mean difference is related to albumin levels in nasal lavages: Unit= ng/ml|||||>0.05
71105161|NCT02958865|141717530|SUPERIORITY||Mean Difference (Final Values)|12.0||||0.0649|TWO_SIDED|90.0|-0.7|22.3|||Chan and Zhang Method|||||22.3|-0.7|0.0649
71105162|NCT02958865|141717530|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|90.0|-11.3|6.1|||Chan and Zhang method|||||6.1|-11.3|1.0000
71105163|NCT02958865|141717530|SUPERIORITY||Mean Difference (Final Values)|14.9||||0.0288|TWO_SIDED|90.0|1.7|26.2|||Chan and Zhang method|||||26.2|1.7|0.0288
71105164|NCT02958865|141717530|SUPERIORITY||Mean Difference (Final Values)|6.4||||0.1593|TWO_SIDED|90.0|-4.4|15.7|||Chan and Zhang method|||||15.7|-4.4|0.1593
71105165|NCT02329587|141717563|OTHER||Between-group effect size (Hedge's g)|0.138|||||TWO_SIDED|||||||||||||
71105166|NCT02329587|141717564|OTHER||Between-group effect size (Hedge's g)|-0.214|||||TWO_SIDED|||||||||||||
71105167|NCT02329587|141717565|OTHER||Between-groups effect size (Hedge's g)|-0.007|||||TWO_SIDED|||||||||||||
71105168|NCT02329587|141717566|OTHER||Between-group effect size (Hedge's g)|-0.151|||||TWO_SIDED|||||||||||||
71016987|NCT03692078|141541632|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|6.883|||<|0.0001|TWO_SIDED|95.0|6.773|6.994|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||6.994|6.773|<.0001
71016988|NCT03692078|141541632|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|6.892|||<|0.0001|TWO_SIDED|95.0|6.78|7.004|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||7.004|6.780|<.0001
71016989|NCT03692078|141541632|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|6.942|||<|0.0001|TWO_SIDED|95.0|6.829|7.054|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||7.054|6.829|<.0001
71016990|NCT03692078|141541632|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|6.896|||<|0.0001|TWO_SIDED|95.0|6.784|7.008|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||7.008|6.784|<.0001
71016991|NCT03692078|141541632|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.879|||<|0.0001|TWO_SIDED|95.0|5.739|6.019|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||6.019|5.739|<.0001
71016992|NCT03692078|141541632|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|5.804|||<|0.0001|TWO_SIDED|95.0|5.662|5.946|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||5.946|5.662|<.0001
71016993|NCT03692078|141541632|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.916|||<|0.0001|TWO_SIDED|95.0|5.778|6.054|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||6.054|5.778|<.0001
71077891|NCT02913105|141664398|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.6022|TWO_SIDED|90.0|0.84|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 28||1.09|0.84|0.6022
70931080|NCT03213457|141362130|SUPERIORITY||LS Mean of Difference|-1.14|STANDARD_ERROR_OF_MEAN|0.322|<|0.001|TWO_SIDED|95.0|-1.774|-0.508||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.508|-1.774|< 0.001
70941575|NCT02402465|141383881|SUPERIORITY||Friedman's Q|14.2||||0.001|TWO_SIDED|||||Bonferroni correction was used to adjust for the fact that each day was tested separately yielding alpha=0.05/3.|Friedman|Non-parametric repeated measures ANOVA||||||0.001
70941576|NCT02402465|141383881|SUPERIORITY||Median Difference (Net)|24.5||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.02
70941577|NCT02402465|141383881|SUPERIORITY||Median Difference (Net)|4.5||||0.003|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.003
70931081|NCT03213457|141362131|SUPERIORITY||LS Mean of Difference|-1.38|STANDARD_ERROR_OF_MEAN|0.303|<|0.001|TWO_SIDED|95.0|-1.978|-0.788||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.788|-1.978|< 0.001
70931082|NCT03213457|141362132|SUPERIORITY||LS Mean of Difference|-1.46|STANDARD_ERROR_OF_MEAN|0.276|<|0.001|TWO_SIDED|95.0|-2.002|-0.915||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.915|-2.002|< 0.001
70931083|NCT05934292|141362141|OTHER||Geometric Mean Ratio|1.5|||||TWO_SIDED|90.0|0.98|2.31|||||Geometric mean ratio (GMR) and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||2.31|0.98|
70931084|NCT05934292|141362141|OTHER||Geometric Mean Ratio|1.14|||||TWO_SIDED|90.0|0.74|1.74|||Geometric Mean Ratio||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||1.74|0.74|
70931085|NCT05934292|141362141|OTHER||Geometric Mean Ratio|1.75|||||TWO_SIDED|90.0|1.1|2.78|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Pre-Hemodialysis/ Panel D-Healthy Controls|||2.78|1.10|
70931086|NCT05934292|141362141|OTHER||Geometric Mean Ratio|1.17|||||TWO_SIDED|90.0|0.77|1.77|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Post-Hemodialysis/ Panel D-Healthy Controls|||1.77|0.77|
70931087|NCT05934292|141362142|OTHER||Geometric Mean Ratio|1.61|||||TWO_SIDED|90.0|1.05|2.46|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||2.46|1.05|
70931088|NCT05934292|141362142|OTHER||Geometric Mean ratio|0.79|||||TWO_SIDED|90.0|0.37|1.72|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||1.72|0.37|
70931089|NCT05934292|141362142|OTHER||Geometric Mean Ratio|1.42|||||TWO_SIDED|90.0|0.8|2.54|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Pre-Hemodialysis/ Panel D-Healthy Controls|||2.54|0.80|
70931090|NCT05934292|141362142|OTHER||Geometric Mean Ratio|1.18|||||TWO_SIDED|90.0|0.78|1.78|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Post-Hemodialysis/ Panel D-Healthy Controls|||1.78|0.78|
70931091|NCT05934292|141362143|OTHER||Geometric Mean Ratio|0.98|||||TWO_SIDED|90.0|0.71|1.37|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls.|||1.37|0.71|
71050682|NCT00546572|141608004|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|2.3|||||TWO_SIDED|95.0|1.66|3.25|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 4: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||3.25|1.66|
70931092|NCT05934292|141362143|OTHER||Geometric Mean Ratio|0.6|||||TWO_SIDED|90.0|0.34|1.04|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls.|||1.04|0.34|
70931093|NCT05934292|141362143|OTHER||Geometric Mean Ratio|0.9|||||TWO_SIDED|90.0|0.64|1.27|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Pre-Hemodialysis/ Panel D-Healthy Controls.|||1.27|0.64|
70931094|NCT05934292|141362143|OTHER||Geometric Mean Ratio|1.18|||||TWO_SIDED|90.0|0.78|1.78|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Post-Hemodialysis/ Panel D-Healthy Controls.|||1.78|0.78|
70931095|NCT05934292|141362146|OTHER||Geometric Mean Ratio|0.67|||||TWO_SIDED|90.0|0.43|1.02|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||1.02|0.43|
70931096|NCT05934292|141362146|OTHER||Geometric Mean Ratio|0.88|||||TWO_SIDED|90.0|0.58|1.35|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||1.35|0.58|
70931097|NCT05934292|141362146|OTHER||Geomtric Mean ratio|0.57|||||TWO_SIDED|90.0|0.36|0.91|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Pre-Hemodialysis/ Panel D-Healthy Controls|||0.91|0.36|
70931098|NCT05934292|141362146|OTHER||Geomtric Mean Ratio|0.86|||||TWO_SIDED|90.0|0.57|1.29|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Post-Hemodialysis/ Panel D-Healthy Controls|||1.29|0.57|
71105169|NCT02329587|141717567|OTHER||Between-groups effect size (Hedge's g)|0.704|||||TWO_SIDED|||||||||||||
71105170|NCT02329587|141717568|OTHER||Odds Ratio (OR)|1.125|||||TWO_SIDED|||||||||||||
70931099|NCT05934292|141362147|OTHER||Geometric Mean Ratio|1.18|||||TWO_SIDED|90.0|0.83|1.67|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||1.67|0.83|
70931100|NCT05934292|141362147|OTHER||Geometric Mean ratio|1.08|||||TWO_SIDED|90.0|0.78|1.5|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||1.50|0.78|
70931101|NCT05934292|141362147|OTHER||Geometric Mean Ratio|0.66|||||TWO_SIDED|90.0|0.5|0.89|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Pre-Hemodialysis/ Panel D-Healthy Controls|||0.89|0.50|
70931102|NCT05934292|141362147|OTHER||Geometric Mean Ratio|1.4|||||TWO_SIDED|90.0|1.0|1.97|||||GMR and 90% CI for AUC0-inf were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Post-Hemodialysis/ Panel D-Healthy Controls|||1.97|1.00|
70931103|NCT05934292|141362152|OTHER||Geometric Mean Ratio|0.32|||||TWO_SIDED|90.0|0.14|0.74|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||0.74|0.14|
70931104|NCT05934292|141362152|OTHER||Geometric Mean Ratio|0.09|||||TWO_SIDED|90.0|0.04|0.22|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||0.22|0.04|
70931105|NCT05934292|141362153|OTHER||Geometric Mean Ratio|0.32|||||TWO_SIDED|90.0|0.14|0.74|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||0.74|0.14|
70931106|NCT05934292|141362153|OTHER||Geometric Mean Ratio|0.09|||||TWO_SIDED|90.0|0.04|0.22|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||0.22|0.04|
70931107|NCT05934292|141362154|OTHER||Geometric Mean Ratio|0.29|||||TWO_SIDED|90.0|0.16|0.55|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||0.55|0.16|
70931108|NCT05934292|141362154|OTHER||Geometric Mean Ratio|0.14|||||TWO_SIDED|90.0|0.06|0.36|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||0.36|0.06|
70931109|NCT05714059|141362162|NON_INFERIORITY|The overall mean change in HbA1c, from baseline to end of 3-month study period was estimated and compared by a non-inferiority test to the threshold of -0.38% with a margin of 0.4%.|Mean difference from baseline to exit|-0.4|||<|0.001|TWO_SIDED|95.0|-0.6|-0.3|||Wilcoxon (Mann-Whitney)||This is one arm study, the differences of HbA1c from baseline to exit were summarized for this endpoint|||-0.3|-0.6|<0.001
70931110|NCT05714059|141362162|NON_INFERIORITY|The overall mean change in HbA1c from baseline to end of 3-month study period was estimated and compared by a non-inferiority test to the threshold of -0.50% with a margin of 0.4%. A significance level of 0.025 (one-sided) was used|Mean difference from baseline to exit|-0.7|||<|0.001|TWO_SIDED|95.0|-0.8|-0.6|||t-test, 1 sided||This is one arm study, the differences of HbA1c from baseline to exit were summarized for this endpoint|||-0.6|-0.8|<0.001
70931111|NCT05714059|141362163|NON_INFERIORITY|The mean % of time in range (TIR 70-180 mg/dL) was estimated and compared by a non-inferiority test to the threshold of 65.3% with a margin of 7.5%.|Mean value (Final Values)|71.4|||<|0.001|TWO_SIDED|95.0|69.5|73.3|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||73.3|69.5|<0.001
70941578|NCT02402465|141383881|SUPERIORITY||Median Difference (Net)|48.5||||0.53|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.53
70931112|NCT05714059|141362163|NON_INFERIORITY|The mean % of time in range (TIR 70-180 mg/dL) was estimated and compared by a non-inferiority test to the threshold of 73.7% with a margin of 7.5%.|Mean value (Final Values)|80.2|||<|0.001|TWO_SIDED|95.0|78.7|81.8|||t-test, 1 sided||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||81.8|78.7|<0.001
70931113|NCT05714059|141362164|NON_INFERIORITY|The mean % time in hypoglycemia (\< 54 mg/dL) was estimated and compared by a non-inferiority test to the threshold of 0.71% with a margin of 2%.|Mean value (Final Values)|0.4|||<|0.001|TWO_SIDED|95.0|0.3|0.4|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Hypoglycemia (\< 54 mg/dL) from last 6-7 weeks of 3 month study period was estimated for this endpoint.|||0.4|0.3|<0.001
70931114|NCT05714059|141362164|NON_INFERIORITY|The mean % time in hypoglycemia (\< 54 mg/dL) was estimated and compared by a non-inferiority test to the threshold of 0.86% with a margin of 2%.|Mean value (Final Values)|0.2|||<|0.001|TWO_SIDED|95.0|0.1|0.3|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Hypoglycemia (\< 54 mg/dL) were summarized from last 6-7 weeks of 3 month study period for this endpoint|||0.3|0.1|<0.001
70931115|NCT05714059|141362165|SUPERIORITY|The mean % of time in range (TIR 70-180 mg/dL) was estimated and compared to a threshold of 65.3% by a simple superiority test|Mean value (Final Values)|71.4|||<|0.001|TWO_SIDED|95.0|69.5|73.3|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||73.3|69.5|<0.001
70931116|NCT05714059|141362165|SUPERIORITY|The mean % of time in range (TIR 70-180 mg/dL) was estimated and compared to a threshold of 73.7% by a simple superiority test|Mean value (Final Values)|80.2|||<|0.001|TWO_SIDED|95.0|78.7|81.8|||t-test, 1 sided||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||81.8|78.7|<0.001
70931117|NCT04899674|141362166|OTHER||Ratio of gMeans [%]|94.6|||||TWO_SIDED|90.0|86.3|103.8|||||"Ratio of Geometric Least Squares Means (gMeans) was calculated as (gMean of BI 1358894 + bupropion)/(gMean of bupropion alone). Intra-individual geometric coefficient of variation (gCV \[%\])=13.9."|The statistical model used for the analysis of the primary endpoints was an Analysis of Variance (ANOVA) model. The model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||103.8|86.3|
70931118|NCT04899674|141362167|OTHER||Ratio of gMeans[%]|90.7|||||TWO_SIDED|90.0|74.3|110.7|||||"Ratio of Geometric Least Squares Means (gMeans) was calculated as (gMean of BI 1358894 + bupropion)/(gMean of bupropion alone).~Intra-individual geometric coefficient of variation (gCV \[%\])=31.5."|The statistical model used for the analysis of the primary endpoints was an Analysis of Variance (ANOVA) model. The model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||110.7|74.3|
70931119|NCT04899674|141362168|OTHER||Ratio of gMeans [%]|95.1|||||TWO_SIDED|90.0|86.7|104.3|||||"Ratio of Geometric Least Squares Means (gMeans) was calculated as (gMean of BI 1358894 + bupropion)/(gMean of bupropion alone).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])=13.9."|The statistical model used for the analysis of the primary endpoints was an Analysis of Variance (ANOVA). The model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||104.3|86.7|
70931120|NCT05155306|141362172|OTHER||Geometric mean ratio [%]|89.1|||||TWO_SIDED|90.0|79.5|99.7|||||Ratio is calculated as test/reference. Geometric Standard Error = 1.067.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||99.7|79.5|
71105171|NCT01380080|141717606|SUPERIORITY_OR_OTHER_LEGACY||Cumulative probability difference|-0.06||||0.97|TWO_SIDED|95.0|-3.05|2.94|||z-test|||Treatment comparison was made using the difference (arm B- arm A) in the Kaplan-Meier estimate for 24 week cumulative probability of death or unknown vital status with 95% confidence interval||2.94|-3.05|0.97
71105172|NCT06378008|141717627|SUPERIORITY||Adjusted Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.092|<|0.0001|TWO_SIDED|95.0|-1.98|-1.62|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 56||-1.62|-1.98|<0.0001
71105173|NCT06378008|141717628|SUPERIORITY||Adjusted Mean Difference|52.87|STANDARD_ERROR_OF_MEAN|2.428|<|0.0001|TWO_SIDED|95.0|48.08|57.65|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 56||57.65|48.08|<0.0001
70931121|NCT05155306|141362172|OTHER||Geometric mean ratio [%]|98.1|||||TWO_SIDED|90.0|94.4|101.9|||||Ratio is calculated as test/reference. Geometric Standard Error = 1.022.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||101.9|94.4|
70931122|NCT05155306|141362172|OTHER||Geometric mean ratio [%]|202.4|||||TWO_SIDED|90.0|180.1|227.5|||||Ratio is calculated as fed/fasted. Geometric Standard Error = 1.069.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||227.5|180.1|
70931123|NCT05155306|141362172|OTHER||Geometric mean ratio [%]|173.8|||||TWO_SIDED|90.0|158.3|190.8|||||Ratio is calculated as fed/fasted. Geometric Standard Error = 1.055.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||190.8|158.3|
70941579|NCT02402465|141383882|SUPERIORITY||Friedman's Q|5.22||||0.07|TWO_SIDED|||||Alpha=0.05/3 since 3 days are compared|Friedman's Test|||We used Friedman test to compare the distribution of total nasal symptom scores among three treatment groups (Placebo, Fluticasone propionate, Dymista) in each of the three days (day 1, day 2, and day 3).||||0.07
70931124|NCT05155306|141362173|OTHER||Geometric mean ratio [%]|83.0|||||TWO_SIDED|90.0|69.6|99.0|||||Ratio is calculated as test/reference. Geometric Standard Error = 1.106.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||99.0|69.6|
70931125|NCT05155306|141362173|OTHER||Geometric mean ratio [%]|99.7|||||TWO_SIDED|90.0|88.7|112.0|||||Ratio is calculated as test/reference. Geometric Standard Error = 1.070.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||112.0|88.7|
70931126|NCT05155306|141362173|OTHER||Geometric mean ratio [%]|153.6|||||TWO_SIDED|90.0|126.0|187.3|||||Ratio is calculated as fed/fasted. Geometric Standard Error = 1.121.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||187.3|126.0|
70941580|NCT02402465|141383883|SUPERIORITY||Friedman's Q|5.06||||0.08|TWO_SIDED|||||Bonferroni correction was used to adjust for the fact that each day was tested separately, giving alpha=0.05/3.|Friedman's Test|||||||0.08
71105174|NCT06378008|141717629|SUPERIORITY||Adjusted Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.053||0.0005|TWO_SIDED|95.0|-0.29|-0.08|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 3||-0.08|-0.29|0.0005
70850870|NCT00612807|141189865|NON_INFERIORITY_OR_EQUIVALENCE|Testing whether slope of change over time varied by identified patient status and treatment condition.|Interaction term|-0.56|STANDARD_ERROR_OF_MEAN|0.29||0.056||95.0||||Interaction indicates that slope of change varied by identified patient status and tx condition. Slope of change in depression was significantly negative for everyone but identified patients in the control condition.|Fixed effect in multi-level model|||Utilized a hierarchical linear model with time nested within individual and individual nested within couple. Given the small sample size, we chose to include participants' baseline depression scores as a covariate, and model the trajectory of change in depression scores beginning with the second assessment, which occurred one month into the study. Additional fixed effect predictors included status as identified patient or spouse, treatment condition, time, and all possible interactions.||||0.056
70850871|NCT00612807|141189866|NON_INFERIORITY_OR_EQUIVALENCE|Testing whether slope of change over time varied by identified patient status and treatment condition.|Interaction term|0.64|STANDARD_ERROR_OF_MEAN|0.65||0.32||95.0|||||Fixed effect in multi-level model|||Utilized a hierarchical linear model with time nested within individual and individual nested within couple. Given the small sample size, we chose to include participants' baseline depression scores as a covariate, and model the trajectory of change in depression scores beginning with the second assessment, which occurred one month into the study. Additional fixed effect predictors included status as identified patient or spouse, treatment condition, time, and all possible interactions.||||0.32
70850872|NCT00612807|141189866|NON_INFERIORITY_OR_EQUIVALENCE|Testing whether means at each timepoint varied by identified patient status and treatment condition.|Interaction term|-12.97|STANDARD_ERROR_OF_MEAN|4.52||0.005||95.0||||We probed this interaction and discovered that at each assessment, spouses in the couple therapy + medication treatment group reported greater dyadic adjustment than did spouses in the medication alone condition (b = 10.53, z = 2.72, p = 0.006).|Fixed effect in multi-level model|||Utilized a hierarchical linear model with time nested within individual and individual nested within couple. Given the small sample size, we chose to include participants' baseline depression scores as a covariate, and model the trajectory of change in depression scores beginning with the second assessment, which occurred one month into the study. Additional fixed effect predictors included status as identified patient or spouse, treatment condition, time, and all possible interactions.||||0.005
70850873|NCT01497366|141189880|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be demonstrated if the lower bound of the 2-sided 95% confidence interval (CI) for the difference in SVR12 rates was greater than -15%.|Difference in percentages|0.3|||||TWO_SIDED|95.0|-7.5|8.0|||||The difference in percentages between treatment groups and the 95% CI calculated were based on stratum adjusted Mantel-Haenszel proportions.|||8.0|-7.5|
70850874|NCT02745080|141189900|SUPERIORITY||Odds Ratio (OR)|1.3||||0.0719|TWO_SIDED|95.0|0.98|1.72|||Regression, Logistic||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment as a factor and baseline weight as a covariate|||1.72|0.98|0.0719
70850875|NCT02745080|141189901|SUPERIORITY||Odds Ratio (OR)|2.49|||<|0.0001|TWO_SIDED|95.0|1.67|3.71|||Regression, Logistic||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment as a factor and baseline weight as a covariate|||3.71|1.67|<0.0001
70850876|NCT02745080|141189902|SUPERIORITY||Odds Ratio (OR)|1.18||||0.2251|TWO_SIDED|95.0|0.9|1.55|||Regression, Logistic||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment as a factor and baseline weight as a covariate|||1.55|0.90|0.2251
70850877|NCT02745080|141189903|SUPERIORITY||least squares (LS) mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.038||0.5465|TWO_SIDED|95.0|-0.1|0.05|||Mixed Models Analysis||Mixed model repeated measures (MMRM) with treatment group, analysis visit as factors, weight/baseline score as covariates, treatment by analysis visit, baseline score by analysis visit as interation terms and unstructured covariance structure|||0.05|-0.10|0.5465
70850878|NCT02745080|141189904|SUPERIORITY||Odds Ratio (OR)|1.3||||0.1498|TWO_SIDED|95.0|0.91|1.87|||Regression, Logistic||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment as a factor and baseline weight as a covariate|||1.87|0.91|0.1498
70850879|NCT05601544|141189914|SUPERIORITY||Least-squares Mean difference|0.22|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001|TWO_SIDED|95.0|0.19|0.25||1-sided p-value was calculated using one-sided type 1 error of 0.025|Mixed Model Analysis|the Kenward and Roger method was used for the calculation of the denominator degrees of freedom.|Least-squares mean difference was calculated as Test minus Control|It was calculated that 41 (for the Multifocal strata) and 6 (for the Sphere strata) participants in each vision group randomized in a 1:1 fashion between the two sequences would have at least a power of 90% (for the Multifocal strata) and a power of 94% (for the Sphere strata) to detect a statistical superiority with respect to visual range.||0.25|0.19|<.0001
71016994|NCT03692078|141541632|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|5.917|||<|0.0001|TWO_SIDED|95.0|5.775|6.058|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||6.058|5.775|<.0001
71016995|NCT03692078|141541632|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|6.017|||<|0.0001|TWO_SIDED|95.0|5.881|6.153|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||6.153|5.881|<.0001
71016996|NCT03692078|141541632|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|6.012|||<|0.0001|TWO_SIDED|95.0|5.874|6.149|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||6.149|5.874|<.0001
71016997|NCT03692078|141541632|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.484|||<|0.0001|TWO_SIDED|95.0|-0.711|-0.257|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.257|-0.711|<.0001
71016998|NCT03692078|141541632|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.476|||<|0.0001|TWO_SIDED|95.0|-0.705|-0.248|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.248|-0.705|<.0001
71016999|NCT03692078|141541632|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.426|||<|0.0001|TWO_SIDED|95.0|-0.654|-0.198|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.198|-0.654|<.0001
71105175|NCT06378008|141717629|SUPERIORITY||Adjusted Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001|TWO_SIDED|95.0|-0.73|-0.49|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 7||-0.49|-0.73|<0.0001
71105176|NCT06378008|141717629|SUPERIORITY||Adjusted Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.092|<|0.0001|TWO_SIDED|95.0|-1.41|-1.04|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 14||-1.04|-1.41|<0.0001
70850880|NCT05601544|141189914|SUPERIORITY||Least-squares Mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.14|0.18||1-sided p-value was calculated using one-sided type 1 error of 0.025|Mixed Model Analysis|the Kenward and Roger method was used for the calculation of the denominator degrees of freedom.|Least-squares mean difference was calculated as Test minus Control|It was calculated that 41 (for the Multifocal strata) and 6 (for the Sphere strata) participants in each vision group randomized in a 1:1 fashion between the two sequences would have at least a power of 90% (for the Multifocal strata) and a power of 94% (for the Sphere strata) to detect a statistical superiority with respect to visual range.||0.18|0.14|<.0001
70850881|NCT05601544|141189917|SUPERIORITY||Median Ratio|0.83||||0.0465|TWO_SIDED|98.33|0.64|1.09||1-sided p-value was calculated using one-sided type 1 error of 0.0083.|Mixed Model Analysis|the Kenward and Roger method was used for the calculation of the denominator degrees of freedom.|Median Ratio was calculated as test over control|It was calculated that 16 participants in each group randomized in a 1:1 fashion between the two sequences would have at least 92% power to detect a statistical superiority with respect to motion detection.||1.09|0.64|0.0465
70931127|NCT05155306|141362173|OTHER||Geometric mean ratio [%]|121.4|||||TWO_SIDED|90.0|99.6|147.8|||||Ratio is calculated as fed/fasted. Geometric Standard Error = 1.120.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||147.8|99.6|
70941581|NCT02402465|141383885|SUPERIORITY||Friedman's Q|6.53||||0.04|TWO_SIDED|||||Bonferroni correction was used to adjust for the fact that each day was tested separately, giving alpha=0.05/3.|Friedman's Test|||||||0.04
70931128|NCT05155306|141362174|OTHER||Geometric mean ratio [%]|89.9|||||TWO_SIDED|90.0|80.4|100.4|||||Ratio is calculated as test/reference. Geometric Standard Error = 1.066.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||100.4|80.4|
71017000|NCT03692078|141541632|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.472|||<|0.0001|TWO_SIDED|95.0|-0.701|-0.244|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.244|-0.701|<.0001
71017001|NCT03692078|141541632|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.489|||<|0.0001|TWO_SIDED|95.0|-1.747|-1.23|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.230|-1.747|<.0001
71017002|NCT03692078|141541632|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Final Values)|-1.564|||<|0.0001|TWO_SIDED|95.0|-1.825|-1.304|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.304|-1.825|<.0001
71017003|NCT03692078|141541632|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.451|||<|0.0001|TWO_SIDED|95.0|-1.706|-1.197|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.197|-1.706|<.0001
71017004|NCT03692078|141541632|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.452|||<|0.0001|TWO_SIDED|95.0|-1.71|-1.193|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.193|-1.710|<.0001
71017005|NCT03692078|141541632|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.866|||<|0.0001|TWO_SIDED|95.0|0.622|1.11|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.110|0.622|<.0001
71017006|NCT03692078|141541632|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.88|||<|0.0001|TWO_SIDED|95.0|0.633|1.128|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.128|0.633|<.0001
71050683|NCT00546572|141608004|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.6|||||TWO_SIDED|95.0|1.21|2.06|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 5: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.06|1.21|
71017007|NCT03692078|141541632|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.924|||<|0.0001|TWO_SIDED|95.0|0.68|1.169|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.169|0.680|<.0001
71017008|NCT03692078|141541632|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.884|||<|0.0001|TWO_SIDED|95.0|0.638|1.131|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.131|0.638|<.0001
70931129|NCT05155306|141362174|OTHER||Geometric mean ratio [%]|100.4|||||TWO_SIDED|90.0|96.8|104.1|||||Ratio is calculated as test/reference. Geometric Standard Error = 1.021.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.1|96.8|
71017009|NCT03692078|141541632|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.138||||0.68|TWO_SIDED|95.0|-0.411|0.134|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.134|-0.411|0.6800
71017010|NCT03692078|141541632|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.208||||0.2371|TWO_SIDED|95.0|-0.483|0.068|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.068|-0.483|0.2371
71017011|NCT03692078|141541632|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.101||||0.9133|TWO_SIDED|95.0|-0.371|0.169|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.169|-0.371|0.9133
71017012|NCT03692078|141541632|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.095||||0.9432|TWO_SIDED|95.0|-0.37|0.18|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.180|-0.370|0.9432
71017013|NCT03692078|141541634|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.513|||<|0.0001|TWO_SIDED|95.0|4.383|4.643|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||4.643|4.383|<.0001
71050684|NCT00546572|141608004|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|3.8|||||TWO_SIDED|95.0|2.78|5.07|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 6B: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||5.07|2.78|
71050685|NCT00546572|141608004|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.2|||||TWO_SIDED|95.0|0.8|1.67|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 7F: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.67|0.80|
70931130|NCT05155306|141362174|OTHER||Geometric mean ratio [%]|202.6|||||TWO_SIDED|90.0|179.6|228.5|||||Ratio is calculated as fed/fasted. Geometric Standard Error = 1.072.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||228.5|179.6|
70931131|NCT05155306|141362174|OTHER||Geometric mean ratio [%]|172.3|||||TWO_SIDED|90.0|158.2|187.7|||||Ratio is calculated as fed/fasted. Geometric Standard Error = 1.050.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||187.7|158.2|
70931132|NCT05648890|141362175|OTHER|Spearman's rank correlation coefficient was used.|||||<|0.0001|||||||Spearman's rank correlation coefficient|||Correlation between MMSE and TEGEST test before operation.||||<0.0001
70931133|NCT05648890|141362176|OTHER|Spearman's ran correlation coefficient was used .|||||<|0.001|||||||Spearman's ran correlation coefficient|Spearman's ran correlation coefficient was used for correlation between two quantities.||Correlation between MMSE and TEGEST after operation||||< .001
71017014|NCT03692078|141541634|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.491|||<|0.0001|TWO_SIDED|95.0|4.371|4.61|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||4.610|4.371|<.0001
71017015|NCT03692078|141541634|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.15|||<|0.0001|TWO_SIDED|95.0|4.027|4.272|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||4.272|4.027|<.0001
71017016|NCT03692078|141541634|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.128|||<|0.0001|TWO_SIDED|95.0|4.014|4.242|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||4.242|4.014|<.0001
71017017|NCT03692078|141541634|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.176|||<|0.0001|TWO_SIDED|95.0|4.051|4.301|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||4.301|4.051|<.0001
71105177|NCT06378008|141717629|SUPERIORITY||Adjusted Mean Difference|-1.56|STANDARD_ERROR_OF_MEAN|0.093|<|0.0001|TWO_SIDED|95.0|-1.74|-1.38|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 28||-1.38|-1.74|<0.0001
70931134|NCT05648890|141362177|OTHER|Spearman's rank correlation coefficient was used.|||||<|0.0001|||||||Spearman's rank correlation coefficient|||Correlation between TEGEST and Clock drawing test before operation.|Spearman's rank correlation coefficient was used.|||<0.0001
71105178|NCT06378008|141717630|SUPERIORITY||Adjusted Mean Difference|7.14|STANDARD_ERROR_OF_MEAN|0.706|<|0.0001|TWO_SIDED|95.0|5.75|8.53|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 3||8.53|5.75|<0.0001
70931135|NCT05648890|141362178|OTHER|Spearman's rank correlation coefficient was used.|||||<|0.001|||||||Spearman's rank correlation coefficient|||Correlation between TEGEST and clock drawing test after operation.||||<0.001
70931136|NCT05648890|141362179|OTHER|Spearman's rank correlation coefficient.|||||<|0.001|||||||Spearman's rank correlation coefficien|||Correlation between MMSE and Clock drawing test before operation.||||<0.001
70931137|NCT05648890|141362179|OTHER|Mann-Whitney U test before operation.||||||0.023|||||||Wilcoxon (Mann-Whitney)|||Clock drawing before operation.||||0.023
70931138|NCT05648890|141362180|OTHER|Spearman's rank correlation coefficient|||||<|0.0001|||||||Spearman's rank correlation coefficient|||Correlation between Clock drawing test and MMSE after operation.||||<0.0001
70931139|NCT05648890|141362181|OTHER|Spearman's rank correlation coefficient was used.|||||<|0.0001|||||||Spearman's rank correlation coefficient|||Correlation of Clinical frailty scale with MMSE before operation.||||<0.0001
70931140|NCT05648890|141362181|OTHER|Spearman's rank correlation coefficient was used.|||||<|0.0001|||||||Spearman's rank correlation coefficient|||Correlation of Clinical frailty scale with TEGEST before operation.||||<0.0001
70931141|NCT05648890|141362181|OTHER|Spearman's rank correlation coefficient was used.|||||<|0.0001|||||||Spearman's rank correlation coefficient|||Correlation of Clinical frailty scale with Clock drawing test before operation.||||<0.0001
70931142|NCT05648890|141362182|OTHER|Mann-Whitney U test.||||||0.562|||||||Wilcoxon (Mann-Whitney)|||Respondents living at a house or in apartment and relationships with Clinical frailty scale.||||.562
70931143|NCT05648890|141362183|OTHER|Mann-Whitney test was used.||||||0.129|||||||Wilcoxon (Mann-Whitney)|||Respondents living with with family or alone and relationship with Clinical frailty scale.||||0.129
70931144|NCT05648890|141362184|OTHER|Mann-Whintney test was used.||||||0.019|||||||Wilcoxon (Mann-Whitney)|||Relationship between respondents living at home with stairs and respondents living at home with an elevator and Clinical frailty scale.||||0.019
70931145|NCT04977583|141362313|SUPERIORITY||Odds Ratio (OR)|1.138|STANDARD_ERROR_OF_MEAN|0.2625||0.6243|TWO_SIDED|95.0|0.679|1.904|||Mixed Models Analysis|||This test is comparing Arm 1 (screening) to Arm 2 (awareness)||1.904|0.679|0.6243
70931146|NCT04977583|141362313|SUPERIORITY||Odds Ratio (OR)|1.497|STANDARD_ERROR_OF_MEAN|0.2553||0.1146|TWO_SIDED|95.0|0.908|2.469|||Mixed Models Analysis|||This test compares Arm 1 (screening) to arm 3 (assistance)||2.469|0.908|0.1146
70931147|NCT04977583|141362314|SUPERIORITY||Risk Ratio (RR)|0.963|STANDARD_ERROR_OF_MEAN|0.2078||0.856|TWO_SIDED|95.0|0.641|1.447|||Poisson|We used total needs as an offset||This test is comparing Arm 1 (screening) to Arm 2 (awareness)||1.447|0.641|0.856
70931148|NCT04977583|141362314|SUPERIORITY||Risk Ratio (RR)|1.136|STANDARD_ERROR_OF_MEAN|0.1999||0.5248|TWO_SIDED|95.0|0.768|1.681|||Poisson|||This test is comparing Arm 1 (screening) to Arm 3 (assistance)||1.681|0.768|0.5248
70931149|NCT04977583|141362315|SUPERIORITY||Odds Ratio (OR)|0.866|STANDARD_ERROR_OF_MEAN|0.22||0.5582|TWO_SIDED|95.0|0.536|1.4|||Regression, Logistic|||This is Arm 1 compared to Arm 2||1.400|0.536|.5582
70931150|NCT04977583|141362315|SUPERIORITY||Odds Ratio (OR)|0.854|STANDARD_ERROR_OF_MEAN|0.217||0.5196|TWO_SIDED|95.0|0.528|1.381|||Regression, Logistic|||This is Arm 1 compared to Arm 3||1.381|0.528|0.5196
70931151|NCT04977583|141362316|SUPERIORITY||Odds Ratio (OR)|1.42|STANDARD_ERROR_OF_MEAN|0.2794||0.2105|TWO_SIDED|95.0|0.821|2.454|||ANOVA|||This is arm 1 compared to arm 2||2.454|0.821|0.2105
71017018|NCT03692078|141541634|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.139|||<|0.0001|TWO_SIDED|95.0|4.024|4.254|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||4.254|4.024|<.0001
71017019|NCT03692078|141541634|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.997|||<|0.0001|TWO_SIDED|95.0|2.842|3.153|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||3.153|2.842|<.0001
71105179|NCT06378008|141717630|SUPERIORITY||Adjusted Mean Difference|14.4|STANDARD_ERROR_OF_MEAN|1.112|<|0.0001|TWO_SIDED|95.0|12.2|16.59|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 7||16.59|12.20|<0.0001
70931152|NCT04977583|141362316|SUPERIORITY||Odds Ratio (OR)|0.7944|STANDARD_ERROR_OF_MEAN|0.2816||0.4143|TWO_SIDED|95.0|0.4574|1.379|||ANOVA|||This is arm 1 compared to arm 3||1.379|0.4574|.4143
70931153|NCT04977583|141362317|SUPERIORITY||Odds Ratio (OR)|0.9995|STANDARD_ERROR_OF_MEAN|0.0171||0.9775|TWO_SIDED|95.0|0.9665|1.0336|||ANOVA|||This arm 1 compared to arm 2||1.0336|0.9665|0.9775
70931154|NCT04977583|141362317|SUPERIORITY||Odds Ratio (OR)|1.017|STANDARD_ERROR_OF_MEAN|0.0176||0.3194|TWO_SIDED|95.0|0.9832|1.0534|||ANOVA|||This arm 1 compared to arm 3||1.0534|0.9832|0.3194
70931155|NCT04977583|141362318|SUPERIORITY||Odds Ratio (OR)|1.0284|STANDARD_ERROR_OF_MEAN|0.1613||0.8623|TWO_SIDED|95.0|0.7497|1.4107|||ANOVA|||This is arm 1 compared to arm 2||1.4107|0.7497|0.8623
70931156|NCT04977583|141362318|SUPERIORITY||Odds Ratio (OR)|1.3701|STANDARD_ERROR_OF_MEAN|0.1626||0.0534|TWO_SIDED|95.0|0.9962|1.8844|||ANOVA|||This is arm 1 compared to arm 3||1.8844|0.9962|0.0534
70931157|NCT04977583|141362319|SUPERIORITY||Odds Ratio (OR)|2.298|STANDARD_ERROR_OF_MEAN|1.464||0.5701|TWO_SIDED|95.0|0.1304|40.5121|||ANOVA|||This is arm 1 compared to arm 2||40.5121|0.1304|0.5701
70931158|NCT04977583|141362319|SUPERIORITY||Odds Ratio (OR)|4.56|STANDARD_ERROR_OF_MEAN|1.467||0.3016|TWO_SIDED|95.0|0.2571|80.8746|||ANOVA|||This is arm 1 compared to arm 3||80.8746|0.2571|0.3016
70931159|NCT04977583|141362320|SUPERIORITY||Odds Ratio (OR)|1.522|STANDARD_ERROR_OF_MEAN|0.2438||0.087|TWO_SIDED|95.0|0.944|2.454|||ANOVA|||This is arm 1 compared to arm 2||2.454|0.944|0.0870
70931160|NCT04977583|141362320|SUPERIORITY||Odds Ratio (OR)|1.85|STANDARD_ERROR_OF_MEAN|0.2897||0.0354|TWO_SIDED|95.0|1.048|3.264|||ANOVA|||This is arm 1 compared to arm 3||3.264|1.048|0.0354
70931161|NCT04977583|141362321|SUPERIORITY||Odds Ratio (OR)|0.618|STANDARD_ERROR_OF_MEAN|0.333||0.3063|TWO_SIDED|95.0|0.246|1.553|||ANOVA|||This is arm 1 compared to arm 2||1.553|0.246|0.3063
70931162|NCT04977583|141362321|SUPERIORITY||Odds Ratio (OR)|0.679|STANDARD_ERROR_OF_MEAN|0.3946||0.4378|TWO_SIDED|95.0|0.256|1.803|||ANOVA|||This is arm 1 compared to arm 3||1.803|.256|.4378
70931163|NCT04977583|141362322|SUPERIORITY||Odds Ratio (OR)|0.5083|STANDARD_ERROR_OF_MEAN|0.8265||0.4134|TWO_SIDED|95.0|0.1006|2.5687|||ANOVA|||This is arm 1 compared to arm 2||2.5687|0.1006|0.4134
70931164|NCT04977583|141362322|SUPERIORITY||Odds Ratio (OR)|1.819|STANDARD_ERROR_OF_MEAN|0.8283||0.4705|TWO_SIDED|95.0|0.3588|9.223|||ANOVA|||This is arm 1 compared to arm 3||9.2230|0.3588|0.4705
70931165|NCT04977583|141362323|SUPERIORITY||Odds Ratio (OR)|1.765|STANDARD_ERROR_OF_MEAN|0.2684||0.0347|TWO_SIDED|95.0|1.044|2.987|||Mixed Models Analysis||This analysis is arm 1 compared to arm 3. Arm 3 is the numerator and arm 1 is the denominator.|||2.987|1.044|0.0347
70931166|NCT04977583|141362324|SUPERIORITY||Odds Ratio (OR)|1.734|STANDARD_ERROR_OF_MEAN|0.3489||0.116|TWO_SIDED|95.0|0.875|3.436|||Mixed Models Analysis||This analysis compares arm 1 to arm 2. Arm 2 is the numerator and Arm 1 is the denominator|||3.436|0.875|0.1160
70931167|NCT04977583|141362324|SUPERIORITY||Odds Ratio (OR)|2.376|STANDARD_ERROR_OF_MEAN|0.3475||0.0134|TWO_SIDED|95.0|1.202|4.695|||Mixed Models Analysis|||||4.695|1.202|0.0134
70941582|NCT02402465|141383886|SUPERIORITY||Friedman's Q|0.53|||>|0.05|TWO_SIDED|||||Bonferroni correction was used to adjust for the fact that each day was tested separately, giving alpha=0.05/3.|Friedman's Test|||||||>0.05
71017020|NCT03692078|141541634|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.994|||<|0.0001|TWO_SIDED|95.0|2.849|3.138|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||3.138|2.849|<.0001
71017021|NCT03692078|141541634|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.317|||<|0.0001|TWO_SIDED|95.0|3.164|3.47|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||3.470|3.164|<.0001
71017022|NCT03692078|141541634|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.342|||<|0.0001|TWO_SIDED|95.0|3.199|3.486|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||3.486|3.199|<.0001
71017023|NCT03692078|141541634|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.036|||<|0.0001|TWO_SIDED|95.0|2.886|3.187|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||3.187|2.886|<.0001
71017024|NCT03692078|141541634|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.159|||<|0.0001|TWO_SIDED|95.0|3.019|3.299|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||3.299|3.019|<.0001
71017025|NCT03692078|141541634|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.363||||0.0008|TWO_SIDED|95.0|-0.613|-0.113|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.113|-0.613|0.0008
71105180|NCT06378008|141717630|SUPERIORITY||Adjusted Mean Difference|25.8|STANDARD_ERROR_OF_MEAN|1.59|<|0.0001|TWO_SIDED|95.0|22.67|28.93|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 14||28.93|22.67|<0.0001
70850882|NCT05601544|141189918|SUPERIORITY||Least-square Mean Difference|0.14|||<|0.0001|TWO_SIDED|98.33|0.112|0.17||1-sided p-value was calculated using one-sided type 1 error of 0.0083|Mixed Model Analysis|the Kenward and Roger method was used for the calculation of the denominator degrees of freedom.|Least-square Mean difference was calculated as Test minus Control|It was calculated that 29 participants in each group randomized in a 1:1 fashion between the two sequences would have at least 91% power to detect a statistical superiority with respect to motion detection.||0.170|0.112|<.0001
70850883|NCT02491632|141189919|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||<.001
70850884|NCT02491632|141189919|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||<.001
70850885|NCT02491632|141189919|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||<.001
70850886|NCT02491632|141189919|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||<.001
70850887|NCT02491632|141189920|OTHER||||||=|0.003|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||=.003
70850888|NCT02491632|141189920|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||<.001
70850889|NCT02491632|141189920|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||<.001
70850890|NCT02491632|141189920|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||<.001
70850891|NCT02491632|141189921|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||<.001
70850892|NCT02491632|141189921|OTHER||||||<|0.065|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||<.065
70850893|NCT02491632|141189921|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||<.001
70850894|NCT02491632|141189921|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||<.001
71105181|NCT06378008|141717630|SUPERIORITY||Adjusted Mean Difference|40.99|STANDARD_ERROR_OF_MEAN|2.254|<|0.0001|TWO_SIDED|95.0|36.55|45.43|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 28||45.43|36.55|<0.0001
71105182|NCT06378008|141717631|SUPERIORITY||Adjusted Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.219||0.3489|TWO_SIDED|95.0|-0.64|0.23|||Mixed Model with Repeated Measures||Adjusted Mean Difference was calculated as Test Toothpaste minus Reference Toothpaste.|Q7 (How intense are the sensations?): Change from Baseline at Day 28||0.23|-0.64|0.3489
71105183|NCT06378008|141717631|SUPERIORITY||Adjusted Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.267||0.0876|TWO_SIDED|95.0|-0.98|0.07|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Q7 (How intense are the sensations?): Change from Baseline at Day 56||0.07|-0.98|0.0876
71105184|NCT06378008|141717631|SUPERIORITY||Adjusted Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.252||0.9108|TWO_SIDED|95.0|-0.47|0.52|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Q8 (How bothered are you by any sensations?): Change from Baseline at Day 28||0.52|-0.47|0.9108
71105185|NCT06378008|141717631|SUPERIORITY||Adjusted Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.281||0.4854|TWO_SIDED|95.0|-0.75|0.36|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Q8 (How bothered are you by any sensations?): Change from Baseline at Day 56||0.36|-0.75|0.4854
71105186|NCT06378008|141717631|SUPERIORITY||Adjusted Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.261||0.8309|TWO_SIDED|95.0|-0.46|0.57|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Q9 (How well can you tolerate sensations?): Change from Baseline at Day 28||0.57|-0.46|0.8309
71105187|NCT06378008|141717631|SUPERIORITY||Adjusted Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.297||0.05|TWO_SIDED|95.0|-1.17|0.0|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Q9 (How well can you tolerate sensations?): Change from Baseline at Day 56||-0.00|-1.17|0.0500
71105188|NCT06378008|141717632|SUPERIORITY||Adjusted Mean Difference|-2.27|STANDARD_ERROR_OF_MEAN|3.859||0.5565|TWO_SIDED|95.0|-9.88|5.33|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||5.33|-9.88|0.5565
71105189|NCT06378008|141717632|SUPERIORITY||Adjusted Mean Difference|-5.96|STANDARD_ERROR_OF_MEAN|4.715||0.2078|TWO_SIDED|95.0|-15.25|3.34|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||3.34|-15.25|0.2078
71105190|NCT06378008|141717633|SUPERIORITY||Adjusted Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.588||0.5597|TWO_SIDED|95.0|-1.5|0.82|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||0.82|-1.50|0.5597
71105191|NCT06378008|141717633|SUPERIORITY||Adjusted Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.705||0.4627|TWO_SIDED|95.0|-1.91|0.87|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||0.87|-1.91|0.4627
71105192|NCT06378008|141717634|SUPERIORITY||Adjusted Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|1.583||0.3|TWO_SIDED|95.0|-4.77|1.48|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||1.48|-4.77|0.3000
71105193|NCT06378008|141717634|SUPERIORITY||Adjusted Mean Difference|-2.53|STANDARD_ERROR_OF_MEAN|1.958||0.1974|TWO_SIDED|95.0|-6.39|1.33|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||1.33|-6.39|0.1974
71105194|NCT06378008|141717635|SUPERIORITY||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.679||0.9203|TWO_SIDED|95.0|-1.27|1.41|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||1.41|-1.27|0.9203
71105195|NCT06378008|141717635|SUPERIORITY||Adjusted Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.717||0.2489|TWO_SIDED|95.0|-2.24|0.58|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||0.58|-2.24|0.2489
71105196|NCT06378008|141717636|SUPERIORITY||Adjusted Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|1.09||0.8496|TWO_SIDED|95.0|-2.36|1.94|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||1.94|-2.36|0.8496
71105197|NCT06378008|141717636|SUPERIORITY||Adjusted Mean Difference|-1.73|STANDARD_ERROR_OF_MEAN|1.226||0.1596|TWO_SIDED|95.0|-4.15|0.69|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||0.69|-4.15|0.1596
71105198|NCT06378008|141717637|SUPERIORITY||Adjusted Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.697||0.9577|TWO_SIDED|95.0|-1.34|1.41|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||1.41|-1.34|0.9577
71105199|NCT06378008|141717637|SUPERIORITY||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.748||0.8261|TWO_SIDED|95.0|-1.64|1.31|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||1.31|-1.64|0.8261
71105200|NCT06378008|141717638|SUPERIORITY||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.089||0.8895|TWO_SIDED|95.0|-0.19|0.16|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||0.16|-0.19|0.8895
71105201|NCT06378008|141717638|SUPERIORITY||Adjusted Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.101||0.8083|TWO_SIDED|95.0|-0.17|0.22|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||0.22|-0.17|0.8083
71105202|NCT06378008|141717639|SUPERIORITY||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.351||0.7362|TWO_SIDED|95.0|-0.57|0.81|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||0.81|-0.57|0.7362
70850895|NCT02491632|141189922|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||<.001
71105203|NCT06378008|141717639|SUPERIORITY||Adjusted Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.39||0.5568|TWO_SIDED|95.0|-1.0|0.54|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||0.54|-1.00|0.5568
71105204|NCT00210132|141717640|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Comparison of proportions.||||0.99
71105205|NCT00210132|141717641|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
71105206|NCT00432965|141717642|SUPERIORITY||Odds Ratio (OR)|1.89||||0.007|TWO_SIDED|95.0|1.19|3.02|||Fisher Exact|||Time Frame: Days 0-114||3.02|1.19|0.007
71105207|NCT04532749|141717662|SUPERIORITY||Least square (LS) mean difference|-1.2|STANDARD_ERROR_OF_MEAN|1.43|=|0.411|TWO_SIDED|95.0|-4.0|1.64|||Mixed Model Repeated Measures (MMRM)|||||1.64|-4.00|=0.411
71105208|NCT04532749|141717663|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|1.27|=|0.473|TWO_SIDED|95.0|-3.41|1.59|||MMRM model|||In accordance with protocol predefined testing sequence, statistical significance of the primary endpoint was required before testing the first secondary endpoint (MADRS-WOSI) and thus, a formal statistical testing was not performed.||1.59|-3.41|=0.473
70850896|NCT02491632|141189922|OTHER||||||=|0.3|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||=.30
70931168|NCT04977583|141362325|SUPERIORITY||Odds Ratio (OR)|5.006|STANDARD_ERROR_OF_MEAN|0.617||0.0094|TWO_SIDED|95.0|1.512|16.57|||Mixed Models Analysis||This analysis is arm 1 compared to compared to arm 3. Arm 3 is the numerator and arm 1 is denominator.|||16.570|1.512|0.0094
71017026|NCT03692078|141541634|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.362||||0.0003|TWO_SIDED|95.0|-0.595|-0.129|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.129|-0.595|0.0003
71017027|NCT03692078|141541634|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.337||||0.0026|TWO_SIDED|95.0|-0.588|-0.085|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.085|-0.588|0.0026
71017028|NCT03692078|141541634|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.351||||0.0004|TWO_SIDED|95.0|-0.584|-0.118|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.118|-0.584|0.0004
71017029|NCT03692078|141541634|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.515|||<|0.0001|TWO_SIDED|95.0|-1.8|-1.23|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.230|-1.800|<.0001
71050686|NCT00546572|141608004|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.8|||||TWO_SIDED|95.0|1.18|2.62|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 9V: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.62|1.18|
71105209|NCT04532749|141717664|SUPERIORITY||LS mean difference|-2.0|STANDARD_ERROR_OF_MEAN|1.45|=|0.167|TWO_SIDED|95.0|-4.87|0.85|||MMRM Model|||In accordance with protocol predefined testing sequence, statistical significance of the primary endpoint was required before testing the second secondary endpoint (PROMIS-SD; Short Form 8a) and thus, a formal statistical testing was not performed.||0.85|-4.87|=0.167
71105210|NCT01230411|141717672|SUPERIORITY||Odds Ratio (OR)|3.12||||0.078|TWO_SIDED|95.0|0.88|11.0|||Regression, Logistic|||||11.0|0.88|0.078
71105211|NCT02255435|141717680|SUPERIORITY||LS Mean difference (Net)|0.1||||0.1524|TWO_SIDED|95.0|-0.04|0.23|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.23|-0.04|0.1524
71105212|NCT02255435|141717680|SUPERIORITY||LS Mean difference (Net)|0.03||||0.7086|TWO_SIDED|95.0|-0.11|0.16|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.16|-0.11|0.7086
71105213|NCT02255435|141717680|SUPERIORITY||LS Mean difference (Net)|-0.13||||0.0651|TWO_SIDED|95.0|-0.26|0.01|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.01|-0.26|0.0651
70850897|NCT02491632|141189922|OTHER||||||=|0.19|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||=.19
70850898|NCT02491632|141189922|OTHER||||||=|0.27|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||=.27
70941583|NCT02402465|141383887|SUPERIORITY||Friedman's Q|0.33||||0.85|TWO_SIDED|||||Bonferroni correction was used to adjust for the fact that each day was tested separately, giving alpha=0.05/3.|Friedman's Test|||||||0.85
70931169|NCT04977583|141362325|SUPERIORITY||Odds Ratio (OR)|1.875|STANDARD_ERROR_OF_MEAN|0.6532||0.3377|TWO_SIDED|95.0|0.521|6.746|||Mixed Models Analysis||This is a comparison of arm 1 and arm 2. Arm 2 is the numerator and arm 1 is the denominator.|||6.746|0.521|0.3377
70931170|NCT02422615|141362326|SUPERIORITY||Cox Proportional Hazard|0.593||||4.1e-07|TWO_SIDED|95.0|0.48|0.732|||Log Rank|||||0.732|0.480|0.00000041
70931171|NCT02422615|141362327|SUPERIORITY||Cox Proportional Hazard|0.724||||0.00455|TWO_SIDED|95.0|0.568|0.924|||Log Rank|||||0.924|0.568|0.00455
70931172|NCT02422615|141362328|SUPERIORITY||Cox Proportional Hazard|0.492|||||TWO_SIDED|95.0|0.345|0.703||||||||0.703|0.345|
70931173|NCT04098575|141362347|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
70931174|NCT04098575|141362348|OTHER|||||||0.835|||||||Chi-squared|||||||0.835
70931175|NCT04098575|141362349|OTHER||||||<|0.001|||||||Chi-squared|||Antihypertensive drugs||||<0.001
70931176|NCT04098575|141362349|OTHER||||||<|0.001|||||||Chi-squared|||Lipid-lowering agents||||<0.001
70931177|NCT04098575|141362349|OTHER||||||<|0.001|||||||Chi-squared|||Antiplatelet, anticoagulant drugs||||<0.001
70931178|NCT04098575|141362349|OTHER||||||<|0.001|||||||Chi-squared|||Glucose-lowering therapies||||<0.001
70931179|NCT04098575|141362350|OTHER||||||<|0.001|||||||Chi-squared|||Group: \< 65||||<0.001
70931180|NCT04098575|141362350|OTHER|||||||0.001|||||||Chi-squared|||Group: 65 ≤ 75||||0.001
70931181|NCT04098575|141362350|OTHER||||||<|0.001|||||||Chi-squared|||Group: 75 - 80||||<0.001
70931182|NCT04098575|141362350|OTHER||||||<|0.002|||||||Chi-squared|||Group: \> 80||||<0.002
70931183|NCT04098575|141362351|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
70931184|NCT04098575|141362352|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
70931185|NCT04098575|141362353|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
70931186|NCT04098575|141362354|OTHER|||||||0.475|||||||Wilcoxon rank sum test|||||||0.475
71105214|NCT02255435|141717680|SUPERIORITY||LS Mean difference (Net)|0.02||||0.7937|TWO_SIDED|95.0|-0.12|0.15|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.15|-0.12|0.7937
71105215|NCT02255435|141717680|SUPERIORITY||LS Mean difference (Net)|-0.04||||0.5587|TWO_SIDED|95.0|-0.18|0.1|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.10|-0.18|0.5587
70850899|NCT03036215|141189935|OTHER||Mean Difference (Net)|-7.0|||||TWO_SIDED|||||||||Pilot study, no power analysis applicable; no statistical test||||
70931187|NCT04098575|141362355|OTHER|||||||0.475|||||||Wilcoxon rank sum test|||||||0.475
70931188|NCT04098575|141362356|OTHER||||||<|0.001|||||||Chi-squared|||Insulin||||<0.001
70931189|NCT04098575|141362356|OTHER||||||<|0.001|||||||Chi-squared|||Metformin||||<0.001
70931190|NCT04098575|141362356|OTHER|||||||0.157|||||||Chi-squared|||Acarbose||||0.157
70931191|NCT04098575|141362356|OTHER||||||<|0.001|||||||Chi-squared|||Sulfonylurea||||<0.001
70931192|NCT04098575|141362356|OTHER|||||||0.071|||||||Chi-squared|||Dipeptidyl peptidase-4 (DPP-4) inhibitors||||0.071
70931193|NCT04098575|141362356|OTHER|||||||0.317|||||||Chi-squared|||Glucagon-like peptide-1 (GLP-1) agonists||||0.317
70931194|NCT04098575|141362356|OTHER||||||<|0.001|||||||Chi-squared|||Sodium-glucose transport protein-2 (SGLT2) inhibitors other than empagliflozin||||<0.001
70931195|NCT04098575|141362357|OTHER||||||<|0.002|||||||Chi-squared|||||||<0.002
70931196|NCT04098575|141362360|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.000
70931197|NCT05274321|141362361|NON_INFERIORITY|The noninferiority margin was determined by taking 10% of the standard of care change score. Noninferiority was determined for each outcome if the noninferiority margin did not overlap with the regression coefficient's 95% confidence interval.||||||0.22||||||Wald P values were calculated by testing whether the regression coefficient met or exceeded the noninferiority margin.|Regression, Linear|The threshold for significance is 0.0167.||Absolute between-eye differences were calculated for each participant by subtracting the standard of care (SOC) change score from the Nanodropper change score. The confidence interval (CI) is 95%.||||0.22
70931198|NCT05274321|141362362|NON_INFERIORITY|The noninferiority margin was determined by taking 10% of the standard of care change score. Noninferiority was determined for each outcome if the noninferiority margin did not overlap with the regression coefficient's 95% confidence interval. .||||||0.02||||||Wald P values were calculated by testing whether the regression coefficient met or exceeded the noninferiority margin.|Regression, Linear|The threshold for significance is 0.0167.||Absolute between-eye differences were calculated for each participant by subtracting the standard of care (SOC) change score from the Nanodropper change score. The confidence interval (CI) is 95%.||||0.02
70931199|NCT05274321|141362363|NON_INFERIORITY|The noninferiority margin was determined by taking 10% of the standard of care change score. Noninferiority was determined for each outcome if the noninferiority margin did not overlap with the regression coefficient's 95% confidence interval.||||||0.03||||||Wald P values were calculated by testing whether the regression coefficient met or exceeded the noninferiority margin.|Regression, Linear|The threshold for significance is 0.0167.||Absolute between-eye differences were calculated for each participant by subtracting the standard of care (SOC) change score from the Nanodropper change score. The confidence interval (CI) is 95%.||||0.03
70931200|NCT05274321|141362364|NON_INFERIORITY|The noninferiority margin was determined by taking 10% of the standard of care change score. Noninferiority was determined for each outcome if the noninferiority margin did not overlap with the regression coefficient's 95% confidence interval.||||||0.25||||||Wald P values were calculated by testing whether the regression coefficient met or exceeded the noninferiority margin.|Regression, Linear|The threshold for significance is 0.0167.||Absolute between-eye differences were calculated for each participant by subtracting the standard of care (SOC) change score from the Nanodropper change score. The confidence interval (CI) is 95%.||||0.25
70931201|NCT01105975|141362365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|78.5|||<|0.001|TWO_SIDED|90.0|64.9|92.1|||mixed model repeated measures (MMRM)|||||92.1|64.9|<0.001
70931202|NCT01105975|141362366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.9||||0.002|TWO_SIDED|90.0|-21.2|-6.7|||mixed model repeated measures (MMRM)|||||-6.7|-21.2|0.002
70931203|NCT01105975|141362367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|56.7|||<|0.001|TWO_SIDED|90.0|43.6|69.8|||mixed model repeated measures (MMRM)|||||69.8|43.6|<0.001
70931204|NCT01105975|141362367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|97.6|||<|0.001||90.0|84.5|110.8|||mixed model repeated measures (MMRM)|||||110.8|84.5|<0.001
71050687|NCT00546572|141608004|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|0.8|||||TWO_SIDED|95.0|0.62|1.13|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 14: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.13|0.62|
70931205|NCT01105975|141362367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|131.9|||<|0.001|TWO_SIDED|90.0|118.5|145.2|||mixed model repeated measures (MMRM)|||||145.2|118.5|<0.001
71017030|NCT03692078|141541634|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.497|||<|0.0001|TWO_SIDED|95.0|-1.762|-1.231|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.231|-1.762|<.0001
71017031|NCT03692078|141541634|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.196|||<|0.0001|TWO_SIDED|95.0|-1.477|-0.915|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.915|-1.477|<.0001
71017032|NCT03692078|141541634|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.148|||<|0.0001|TWO_SIDED|95.0|-1.41|-0.886|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.886|-1.410|<.0001
71017033|NCT03692078|141541634|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|1.113|||<|0.0001|TWO_SIDED|95.0|0.844|1.382|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.382|0.844|<.0001
71017034|NCT03692078|141541634|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.969|||<|0.0001|TWO_SIDED|95.0|0.717|1.221|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.221|0.717|<.0001
71017035|NCT03692078|141541634|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|1.139|||<|0.0001|TWO_SIDED|95.0|0.869|1.41|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.410|0.869|<.0001
71017036|NCT03692078|141541634|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.98|||<|0.0001|TWO_SIDED|95.0|0.728|1.231|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.231|0.728|<.0001
71050688|NCT00546572|141608004|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|2.0|||||TWO_SIDED|95.0|1.53|2.69|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 18C: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.69|1.53|
70931206|NCT01105975|141362368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.6|||<|0.001|TWO_SIDED|90.0|-24.6|-10.5|||mixed model repeated measures (MMRM)|||||-10.5|-24.6|<0.001
70850900|NCT03036215|141189936|OTHER|pilot study; no statistical test performed|Mean Difference (Net)|1.0|||||TWO_SIDED|||||||||Pilot study; no statistical test run||||
71017037|NCT03692078|141541634|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.039||||1|TWO_SIDED|95.0|-0.34|0.262|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.262|-0.340|1.0000
71017038|NCT03692078|141541634|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.166||||0.5184|TWO_SIDED|95.0|-0.447|0.115|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.115|-0.447|0.5184
71017039|NCT03692078|141541634|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.28||||0.0743|TWO_SIDED|95.0|-0.017|0.578|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.578|-0.017|0.0743
71017040|NCT03692078|141541634|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.183||||0.3889|TWO_SIDED|95.0|-0.095|0.462|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.462|-0.095|0.3889
71017041|NCT03692078|141541636|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.264|||<|0.0001|TWO_SIDED|95.0|5.155|5.373|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||5.373|5.155|<.0001
71017042|NCT03692078|141541636|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|5.204|||<|0.0001|TWO_SIDED|95.0|5.106|5.302|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||5.302|5.106|<.0001
71017043|NCT03692078|141541636|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.005|||<|0.0001|TWO_SIDED|95.0|4.902|5.108|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||5.108|4.902|<.0001
71050689|NCT00546572|141608004|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.7|||||TWO_SIDED|95.0|1.37|2.1|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 19A: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.10|1.37|
71050690|NCT00546572|141608004|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.09|1.93|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 19F: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.93|1.09|
70850901|NCT03036215|141189937|OTHER||Mean Difference (Net)|-5.2|||||TWO_SIDED|||||||||Pilot study; no statistical test for significance run||||
70850902|NCT01256294|141189950|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.02|||||TWO_SIDED|95.0|0.96|1.09||||||||1.09|0.96|
70931207|NCT01105975|141362368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.2|||<|0.001|TWO_SIDED|90.0|-33.2|-19.2|||mixed model repeated measures (MMRM)|||||-19.2|-33.2|<0.001
70931208|NCT01105975|141362368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.8|||<|0.001|TWO_SIDED|90.0|-47.0|-32.7|||mixed model repeated measures (MMRM)|||||-32.7|-47.0|<0.001
70931209|NCT01105975|141362369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|79.3|||<|0.001||90.0|66.2|92.4|||mixed model repeated measures (MMRM)|||||92.4|66.2|<0.001
71050691|NCT00546572|141608004|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|7.3|||||TWO_SIDED|95.0|5.36|9.82|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 23F: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||9.82|5.36|
71017044|NCT03692078|141541636|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.958|||<|0.0001|TWO_SIDED|95.0|4.864|5.051|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||5.051|4.864|<.0001
71017045|NCT03692078|141541636|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.114|||<|0.0001|TWO_SIDED|95.0|5.009|5.219|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||5.219|5.009|<.0001
71017046|NCT03692078|141541636|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|5.052|||<|0.0001|TWO_SIDED|95.0|4.958|5.146|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||5.146|4.958|<.0001
71017047|NCT03692078|141541636|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.539|||<|0.0001|TWO_SIDED|95.0|4.407|4.671|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||4.671|4.407|<.0001
71017048|NCT03692078|141541636|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.415|||<|0.0001|TWO_SIDED|95.0|4.295|4.534|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||4.534|4.295|<.0001
71017049|NCT03692078|141541636|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.431|||<|0.0001|TWO_SIDED|95.0|4.302|4.56|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||4.560|4.302|<.0001
71050692|NCT00546572|141608005|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|12.1|||||TWO_SIDED|95.0|8.92|16.44|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|"Serotype 6A: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.~Statistical significance was demonstrated if the lower limit of the 2-sided 95% confidence interval for the geometric mean ratio was \>2."||16.44|8.92|
71105216|NCT02255435|141717680|SUPERIORITY||LS Mean difference (Net)|-0.02||||0.7285|TWO_SIDED|95.0|-0.13|0.09|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.09|-0.13|0.7285
71105217|NCT02255435|141717680|SUPERIORITY||LS Mean difference (Net)|0.03||||0.5802|TWO_SIDED|95.0|-0.09|0.15|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.15|-0.09|0.5802
70931210|NCT01105975|141362369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|88.5|||<|0.001|TWO_SIDED|90.0|75.2|101.8|||mixed model repeated measures (MMRM)|||||101.8|75.2|<0.001
70931211|NCT01105975|141362370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.2||||0.009|TWO_SIDED|90.0|-18.3|-4.2|||mixed model repeated measures (MMRM)|||||-4.2|-18.3|0.009
70931212|NCT01105975|141362370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.5||||0.002|TWO_SIDED|90.0|-20.6|-6.4|||mixed model repeated measures (MMRM)|||||-6.4|-20.6|0.002
70931213|NCT00195403|141362383|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from baseline in PGA at Month 3 was evaluated using paired t-test.||||<0.0001
70931214|NCT00195403|141362384|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from baseline in number of joints with tenderness, pain, and limitation of motion or swelling at Month 3 were evaluated using paired t-test.||||<0.0001
71017050|NCT03692078|141541636|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.361|||<|0.0001|TWO_SIDED|95.0|4.243|4.48|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||4.480|4.243|<.0001
70931215|NCT05601882|141362412|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|11.0|||<|0.0001|TWO_SIDED|95.0|6.6|15.5|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||15.5|6.6|<0.0001
71017051|NCT03692078|141541636|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.486|||<|0.0001|TWO_SIDED|95.0|4.359|4.612|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||4.612|4.359|<.0001
71017052|NCT03692078|141541636|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.588|||<|0.0001|TWO_SIDED|95.0|4.473|4.703|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||4.703|4.473|<.0001
71017053|NCT03692078|141541636|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.259||||0.0073|TWO_SIDED|95.0|-0.469|-0.049|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.049|-0.469|0.0073
71017054|NCT03692078|141541636|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.246||||0.0041|TWO_SIDED|95.0|-0.438|-0.055|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.055|-0.438|0.0041
71105218|NCT02255435|141717680|SUPERIORITY||LS Mean difference (Net)|0.0||||0.9698|TWO_SIDED|95.0|-0.08|0.08|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|Comparison of Omaveloxolone capsules pooled with Placebo capsules||0.08|-0.08|0.9698
70931216|NCT05601882|141362413|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|18.4|||<|0.0001|TWO_SIDED|95.0|12.5|24.2|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||24.2|12.5|<0.0001
70931217|NCT05601882|141362414|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|14.7|||<|0.0001|TWO_SIDED|95.0|9.4|20.0|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||20.0|9.4|<0.0001
70931218|NCT05601882|141362415|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|16.6|||<|0.0001|TWO_SIDED|95.0|10.2|23.0|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||23.0|10.2|<0.0001
71105219|NCT02255435|141717681|SUPERIORITY||LS Mean difference (Net)|-2.4|STANDARD_ERROR_OF_MEAN|0.956||0.0141|TWO_SIDED|95.0|-4.31|-0.5|||Mixed Models Analysis|Fixed factors: treatment group, time, interaction between treatment and time, interaction between baseline and time; covariates: site, baseline mFARS|Difference is omaveloxolone - placebo.|||-0.50|-4.31|0.0141
71105220|NCT02255435|141717682|SUPERIORITY||LS Mean difference (Net)|-1.81||||0.231|TWO_SIDED|95.0|-4.8|1.18|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||1.18|-4.80|0.2310
71017055|NCT03692078|141541636|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.15||||0.308|TWO_SIDED|95.0|-0.361|0.061|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.061|-0.361|0.3080
71017056|NCT03692078|141541636|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.152||||0.1982|TWO_SIDED|95.0|-0.343|0.039|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.039|-0.343|0.1982
71017057|NCT03692078|141541636|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.725|||<|0.0001|TWO_SIDED|95.0|-0.965|-0.486|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.486|-0.965|<.0001
71050693|NCT00546572|141608006|SUPERIORITY_OR_OTHER||difference in proportions|-11.4|||<|0.001|TWO_SIDED|95.0|-17.3|-5.6|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Redness: any; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-5.6|-17.3|<0.001
70931219|NCT05601882|141362416|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|13.2|||<|0.0001|TWO_SIDED|95.0|9.6|16.9|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||16.9|9.6|<0.0001
71017058|NCT03692078|141541636|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.79|||<|0.0001|TWO_SIDED|95.0|-1.008|-0.571|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.571|-1.008|<.0001
71017059|NCT03692078|141541636|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.833|||<|0.0001|TWO_SIDED|95.0|-1.069|-0.597|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.597|-1.069|<.0001
71017060|NCT03692078|141541636|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.843|||<|0.0001|TWO_SIDED|95.0|-1.059|-0.627|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.627|-1.059|<.0001
71017061|NCT03692078|141541636|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.52|||<|0.0001|TWO_SIDED|95.0|0.294|0.745|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||0.745|0.294|<.0001
71050694|NCT00546572|141608006|SUPERIORITY_OR_OTHER||difference in proportions|-4.0||||0.129|TWO_SIDED|95.0|-9.1|1.1|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Redness: mild; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||1.1|-9.1|0.129
71050695|NCT00546572|141608006|SUPERIORITY_OR_OTHER||difference in proportions|-6.8||||0.002|TWO_SIDED|95.0|-11.3|-2.3|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Redness: moderate; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-2.3|-11.3|0.002
71105221|NCT02255435|141717682|SUPERIORITY||LS Mean difference (Net)|-0.52||||0.7298|TWO_SIDED|95.0|-3.51|2.47|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||2.47|-3.51|0.7298
71017062|NCT03692078|141541636|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.37|||<|0.0001|TWO_SIDED|95.0|0.163|0.577|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||0.577|0.163|<.0001
70850903|NCT01256294|141189950|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.02||||0.486|TWO_SIDED|90.0|0.97|1.08||ANOVA model for the dose-normalized log transformed values with treatment, period and sequence as fixed factors and subjects nested within sequences as a random factor.|ANOVA|||To compare the bioavailability of generic tacrolimus to branded tacrolimus, the 90% confidence intervals of the ratios of geometric means of AUC0-12h were assessed relative to the interval \[80%, 125%\].||1.08|0.97|0.486
70850904|NCT01256294|141189955|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.09|||||TWO_SIDED|95.0|1.0|1.2|||||Ratio of geometric means: Generic tacrolimus/Branded tacrolimus|||1.20|1.00|
70850905|NCT01256294|141189955|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.09||||0.057|TWO_SIDED|90.0|1.01|1.18||ANOVA model for the dose-normalized log transformed values with treatment, period and sequence as fixed factors and subjects nested within sequences as a random factor.|ANOVA|||To compare the bioavailability of generic tacrolimus to branded tacrolimus, the 90% confidence intervals of the ratios of geometric means of Cmax were assessed relative to the interval \[80%, 125%\].||1.18|1.01|0.057
71017063|NCT03692078|141541636|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.628|||<|0.0001|TWO_SIDED|95.0|0.402|0.855|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||0.855|0.402|<.0001
71017064|NCT03692078|141541636|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.464|||<|0.0001|TWO_SIDED|95.0|0.257|0.67|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||0.670|0.257|<.0001
71017065|NCT03692078|141541636|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.053||||0.9984|TWO_SIDED|95.0|-0.2|0.306|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.306|-0.200|0.9984
71050696|NCT00546572|141608006|SUPERIORITY_OR_OTHER||difference in proportions|-3.2||||0.028|TWO_SIDED|95.0|-6.3|-0.3|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Redness: severe; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-0.3|-6.3|0.028
71050697|NCT00546572|141608006|SUPERIORITY_OR_OTHER||difference in proportions|-12.7|||<|0.001|TWO_SIDED|95.0|-18.5|-7.0|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Swelling: any; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-7.0|-18.5|<0.001
71050698|NCT00546572|141608006|SUPERIORITY_OR_OTHER||difference in proportions|-5.1||||0.048|TWO_SIDED|95.0|-10.2|-0.1|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Swelling: mild; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-0.1|-10.2|0.048
71050699|NCT00546572|141608006|SUPERIORITY_OR_OTHER||difference in proportions|-9.6|||<|0.001|TWO_SIDED|95.0|-14.2|-5.1|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Swelling: moderate; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-5.1|-14.2|<0.001
70850906|NCT04838977|141189997|SUPERIORITY||Between group difference|-4.2|||||TWO_SIDED|95.0|-7.6|-0.8||||||The null hypothesis is there is no difference in mean CPSS at 10 weeks in the intervention group versus the control group.||-0.8|-7.6|
70850907|NCT04780919|141190007|SUPERIORITY|||||||0.722||||||p-value is adjusted to comparison between the Group A and Group B at 3 weeks follow-up after the last application.|Two-way ANOVA|||The Group A will have significantly decreased Cross Section Area compared to Group B at 3 weeks follow up after last application.||||0.722
70850908|NCT04780919|141190008|SUPERIORITY|||||||0.096||||||p-value is adjusted to comparison between the Group A and Group B in the timeframe of the last application.|Two-way ANOVA|||The maximum pain will decrease significantly more in Group A compared to Group B in the timeframe of the last application compared to baseline.||||0.096
71017066|NCT03692078|141541636|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.173||||0.2491|TWO_SIDED|95.0|-0.405|0.058|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.058|-0.405|0.2491
71017067|NCT03692078|141541636|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.054||||0.9977|TWO_SIDED|95.0|-0.304|0.195|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.195|-0.304|0.9977
71017068|NCT03692078|141541636|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.227||||0.0554|TWO_SIDED|95.0|-0.456|0.003|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.003|-0.456|0.0554
71050700|NCT00546572|141608006|SUPERIORITY_OR_OTHER||difference in proportions|-4.8|||<|0.001|TWO_SIDED|95.0|-7.9|-2.7|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Swelling: severe; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-2.7|-7.9|<0.001
71050701|NCT00546572|141608006|SUPERIORITY_OR_OTHER||Chan & Zhang|-6.8||||0.062|TWO_SIDED|95.0|-14.0|0.4|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Pain: any; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||0.4|-14.0|0.062
71050702|NCT00546572|141608006|SUPERIORITY_OR_OTHER||difference in proportions|-4.0||||0.284|TWO_SIDED|95.0|-11.3|3.3|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Pain: mild; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||3.3|-11.3|0.284
71105222|NCT02255435|141717682|SUPERIORITY||LS Mean difference (Net)|-0.99||||0.5102|TWO_SIDED|95.0|-3.99|2.0|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||2.00|-3.99|0.5102
70850909|NCT04780919|141190009|SUPERIORITY|||||||0.035||||||p-value is adjusted to comparison between the Group A and Group B at the 3 weeks follow up compared to baseline.|Two-way ANOVA|||The maximum pain will decrease significantly more in Group A compared to Group B at the 3 weeks follow up compared to baseline.||||0.035
70850910|NCT04780919|141190010|SUPERIORITY|||||||0.171||||||p-value is adjusted to comparison between the Group A and Group B at the 3 weeks follow up compared to baseline.|Two-way ANOVA|||The maximum of ankle dorsiflexion range of motion will increase significantly more in Group A compared to Group B at the 3 weeks follow up compared to baseline.||||0.171
70850911|NCT04780919|141190013|SUPERIORITY|||||||0.104||||||p-value is adjusted to comparison between the Group A and Group B in 3 weeks follow up after the last application.|Two-way ANOVA|||The VISA-A score will increase significantly more in Group A compared to Group B at the 3 weeks follow up compared to baseline.||||0.104
70850912|NCT00373113|141190062|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.47||||0.002|TWO_SIDED|95.0|1.156|1.869||2-sided log-rank test with the same set of stratification factors. The set of stratification factors included those used in the randomization except study sites.|Log Rank||Hazard ratio was calculated by the stratified Cox proportional hazards model.|Null hypothesis is that PFS (median=4.2 months) for sunitinib arm equals PFS for capecitabine arm. The study was designed to have 90% power to detect statistical difference in PFS between two treatment groups assuming the hazard ratio (sunitinib/capecitabine) is 0.75 and both arms follow exponential distribution.||1.869|1.156|0.002
70850913|NCT00373113|141190063|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.516|||<|0.001|TWO_SIDED|95.0|1.188|1.933||2-sided log-rank test with the same set of stratification factors that was used in the randomization except study sites.|Log Rank||Hazard ratio was calculated by the stratified Cox proportional hazards model.|||1.933|1.188|<0.001
70850914|NCT00373113|141190064|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|11.3|||||TWO_SIDED|95.0|7.6|16.1||||||||16.1|7.6|
70850915|NCT00373113|141190064|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|16.4|||||TWO_SIDED|95.0|12.0|21.6||||||||21.6|12.0|
70931220|NCT05601882|141362417|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|6.4|||<|0.0001|TWO_SIDED|95.0|3.8|9.1|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||9.1|3.8|<0.0001
70850916|NCT00373113|141190064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.049||||0.109|TWO_SIDED|95.0|-11.2|1.1|||Pearson Chi-Square Test|||||1.1|-11.2|0.109
70850917|NCT00373113|141190065|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.788||||0.037|TWO_SIDED|95.0|1.042|7.459|||Log Rank|||||7.459|1.042|0.037
70850918|NCT00373113|141190067|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.202||||0.219|TWO_SIDED|95.0|0.896|1.611||2-sided log-rank test with the same set of stratification factors that were used in the randomization except study sites.|Log Rank|||||1.611|0.896|0.219
70931221|NCT05601882|141362418|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|14.1|||<|0.0001|TWO_SIDED|95.0|9.4|18.8|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||18.8|9.4|<0.0001
70931222|NCT05601882|141362419|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|18.6|||<|0.0001|TWO_SIDED|95.0|13.9|23.3|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||23.3|13.9|<0.0001
70931223|NCT05601882|141362420|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|9.3|||<|0.0001|TWO_SIDED|95.0|5.4|13.1|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||13.1|5.4|<0.0001
70931224|NCT04121741|141362421|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.42||0.864|TWO_SIDED|||||Using Bonferroni correction for 3 primary outcomes (FMD, RHI, fRHI), a priori threshold for statistical significance was p\<0.0167.|Regression, Linear|Included outlier detection and removal with estimation of standard models for a three-treatment, cross-over design.|Estimated mean difference for FMD% (singing video intervention compared to control) is shown. Estimates of FMD% for singing coach intervention compared to control also performed.||"Please reference the following pre-print manuscript for additional statistical analyses.~Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv \[Preprint\]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. PMID: 39108506; PMCID: PMC11302710."|||0.864
70931225|NCT04121741|141362421|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.42||0.913|TWO_SIDED|||||Using Bonferroni correction for 3 primary outcomes (FMD, RHI, fRHI), a priori threshold for statistical significance was p\<0.0167.|Regression, Linear|Included outlier detection and removal with estimation of standard models for a three-treatment, cross-over design.|Estimated mean difference for FMD% (singing coach intervention compared to control) is shown. Estimates of FMD% for singing video intervention compared to control also performed.||"Please reference the following pre-print manuscript for additional statistical analyses.~Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv \[Preprint\]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. PMID: 39108506; PMCID: PMC11302710."|||0.913
70931226|NCT04121741|141362422|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.13||0.29|TWO_SIDED|||||Using Bonferroni correction for 3 primary outcomes (FMD, RHI, fRHI), a priori threshold for statistical significance was p\<0.0167.|Regression, Linear|Included outlier detection and removal with estimation of standard models for a three-treatment, cross-over design.|Estimated mean difference for RHI (singing video intervention compared to control) is shown. Estimates of RHI for singing coach intervention compared to control also performed.||"Please reference the following pre-print manuscript for additional statistical analyses.~Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv \[Preprint\]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. PMID: 39108506; PMCID: PMC11302710."|||0.290
71017069|NCT03692078|141541638|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.294|||<|0.0001|TWO_SIDED|95.0|3.208|3.379|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||3.379|3.208|<.0001
70931227|NCT04121741|141362422|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.12||0.462|TWO_SIDED|||||Using Bonferroni correction for 3 primary outcomes (FMD, RHI, fRHI), a priori threshold for statistical significance was p\<0.0167.|Regression, Linear|Included outlier detection and removal with estimation of standard models for a three-treatment, cross-over design.|Estimated mean difference for RHI (singing coach intervention compared to control) is shown. Estimates of RHI for singing video intervention compared to control also performed.||"Please reference the following pre-print manuscript for additional statistical analyses.~Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv \[Preprint\]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. PMID: 39108506; PMCID: PMC11302710."|||0.462
70941584|NCT03807700|141383888|SUPERIORITY||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|0.58||0.4769|TWO_SIDED|95.0|-1.56|0.74|||ANCOVA|Analysis was performed using ANCOVA model with study product as a fixed effect and Baseline overall score as a covariate.|Difference is experimental adhesive minus no adhesive.|||0.74|-1.56|0.4769
70941585|NCT03209050|141383897|OTHER|||||||0.5|||||||Clopper-Pearson 95% CI|||||||0.5
71050703|NCT00546572|141608006|SUPERIORITY_OR_OTHER||difference in proportions|-16.1|||<|0.001|TWO_SIDED|95.0|-21.7|-10.6|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Pain: moderate; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-10.6|-21.7|<0.001
71050704|NCT00546572|141608006|SUPERIORITY_OR_OTHER||difference in proportions|-0.9||||0.539|TWO_SIDED|95.0|-3.5|1.4|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Pain: severe; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||1.4|-3.5|0.539
71017070|NCT03692078|141541638|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.262|||<|0.0001|TWO_SIDED|95.0|3.176|3.348|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||3.348|3.176|<.0001
71017071|NCT03692078|141541638|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.12|||<|0.0001|TWO_SIDED|95.0|3.039|3.202|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||3.202|3.039|<.0001
71017072|NCT03692078|141541638|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.099|||<|0.0001|TWO_SIDED|95.0|3.017|3.181|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||3.181|3.017|<.0001
71017073|NCT03692078|141541638|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.182|||<|0.0001|TWO_SIDED|95.0|3.1|3.264|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||3.264|3.100|<.0001
71017074|NCT03692078|141541638|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.149|||<|0.0001|TWO_SIDED|95.0|3.066|3.231|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||3.231|3.066|<.0001
71017075|NCT03692078|141541638|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.777|||<|0.0001|TWO_SIDED|95.0|2.673|2.881|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||2.881|2.673|<.0001
71017076|NCT03692078|141541638|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.651|||<|0.0001|TWO_SIDED|95.0|2.546|2.756|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||2.756|2.546|<.0001
71017077|NCT03692078|141541638|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.72|||<|0.0001|TWO_SIDED|95.0|2.618|2.823|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||2.823|2.618|<.0001
71017078|NCT03692078|141541638|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.649|||<|0.0001|TWO_SIDED|95.0|2.544|2.753|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||2.753|2.544|<.0001
71105223|NCT02255435|141717682|SUPERIORITY||LS Mean difference (Net)|-0.95||||0.5281|TWO_SIDED|95.0|-3.94|2.04|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||2.04|-3.94|0.5281
70941586|NCT02005029|141383899|SUPERIORITY_OR_OTHER|||||||0.036|||||||t-test, 2 sided|||||||0.036
70931228|NCT04121741|141362423|SUPERIORITY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|0.19||0.005|TWO_SIDED|||||Using Bonferroni correction for 3 primary outcomes (FMD, RHI, fRHI), a priori threshold for statistical significance was p\<0.0167.|Regression, Linear|Included outlier detection and removal with estimation of standard models for a three-treatment, cross-over design.|Estimated mean difference for fRHI (singing video intervention compared to control) is shown. Estimates of fRHI for singing coach intervention compared to control also performed.||"Please reference the following pre-print manuscript for additional statistical analyses.~Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv \[Preprint\]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. PMID: 39108506; PMCID: PMC11302710."|||0.005
70931229|NCT04121741|141362423|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.18||0.57|TWO_SIDED|||||Using Bonferroni correction for 3 primary outcomes (FMD, RHI, fRHI), a priori threshold for statistical significance was p\<0.0167.|Regression, Linear|Included outlier detection and removal with estimation of standard models for a three-treatment, cross-over design.|Estimated mean difference for fRHI (singing coach intervention compared to control) is shown. Estimates of fRHI for singing video intervention compared to control also performed.||"Please reference the following pre-print manuscript for additional statistical analyses.~Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv \[Preprint\]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. PMID: 39108506; PMCID: PMC11302710."|||0.570
70931230|NCT03473223|141362433|SUPERIORITY||Hazard Ratio (HR)|0.925||||0.121|TWO_SIDED|95.0|0.8126|1.0538||1-sided p-value.|Cox proportional hazards regression|||||1.0538|0.8126|0.121
71105224|NCT02255435|141717682|SUPERIORITY||LS Mean difference (Net)|-1.42||||0.3458|TWO_SIDED|95.0|-4.42|1.57|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||1.57|-4.42|0.3458
70931231|NCT03473223|141362434|SUPERIORITY||Rate ratio|0.971||||0.341|TWO_SIDED|95.0|0.8442|1.1171||1-sided p-value|Negative binomial regression model|||||1.1171|0.8442|0.341
70931232|NCT03473223|141362435|SUPERIORITY||Hazard Ratio (HR)|0.907||||0.038|TWO_SIDED|95.0|0.8132|1.0106||1-sided p-value.|Cox proportional hazards regression|||||1.0106|0.8132|0.038
70931233|NCT03473223|141362436|SUPERIORITY||Hazard Ratio (HR)|0.933||||0.069|TWO_SIDED|95.0|0.8511|1.0224||1-sided p-value.|Cox proportional hazards regression|||||1.0224|0.8511|0.069
70931234|NCT03473223|141362437|SUPERIORITY||Hazard Ratio (HR)|0.827||||0.074|TWO_SIDED|95.0|0.6399|1.0695||1-sided p-value.|Cox proportional hazards regression|||||1.0695|0.6399|0.074
70931235|NCT03473223|141362438|SUPERIORITY||Hazard Ratio (HR)|0.909||||0.113|TWO_SIDED|95.0|0.7801|1.0603||1-sided p-value.|Cox proportional hazards regression|||||1.0603|0.7801|0.113
70931236|NCT03473223|141362439|SUPERIORITY||Hazard Ratio (HR)|1.153||||0.767|TWO_SIDED|95.0|0.7867|1.6886||1-sided p-value.|Cox proportional hazards regression|||||1.6886|0.7867|0.767
70931237|NCT03524092|141362458|SUPERIORITY||Risk Difference (RD)|23.2|||<|0.001|TWO_SIDED|95.0|15.2|31.2|||Cochran-Mantel-Haenszel|||||31.2|15.2|<0.001
70931238|NCT03524092|141362459|SUPERIORITY||Risk Difference (RD)|28.5|||<|0.001|TWO_SIDED|95.0|20.2|36.8|||Cochran-Mantel-Haenszel|||||36.8|20.2|<0.001
70931239|NCT03524092|141362460|SUPERIORITY||Risk Difference (RD)|22.5|||<|0.001|TWO_SIDED|95.0|14.5|30.5|||Cochran-Mantel-Haenszel|||||30.5|14.5|<0.001
70931240|NCT03524092|141362461|SUPERIORITY||Risk Difference (RD)|30.2|||<|0.001|TWO_SIDED|95.0|21.9|38.6|||Cochran-Mantel-Haenszel|||||38.6|21.9|<0.001
70931241|NCT03524092|141362462|SUPERIORITY||Risk Difference (RD)|31.0|||<|0.001|TWO_SIDED|95.0|22.4|39.6|||Cochran-Mantel-Haenszel|||||39.6|22.4|<0.001
70931242|NCT03524092|141362463|SUPERIORITY||Risk Difference (RD)|30.6|||<|0.001|TWO_SIDED|95.0|22.3|38.9|||Cochran-Mantel-Haenszel|||||38.9|22.3|<0.001
70931243|NCT03524092|141362464|SUPERIORITY||LS Mean difference (Final Values)|25.24|STANDARD_ERROR_OF_MEAN|3.094|<|0.001|TWO_SIDED|95.0|19.16|31.32|||ANCOVA|ANCOVA with modified baseline observation carried forward (mBOCF).||||31.32|19.16|<0.001
70931244|NCT03524092|141362465|SUPERIORITY||LS Mean difference (Final Values)|-839.64|STANDARD_ERROR_OF_MEAN|245.99|<|0.001|TWO_SIDED|95.0|-1323.08|-356.21|||ANCOVA|ANCOVA with modified baseline observation carried forward (mBOCF).||||-356.21|-1323.08|<0.001
70931245|NCT03524092|141362466|SUPERIORITY||LS Mean difference (Final Values)|-1.06|STANDARD_ERROR_OF_MEAN|0.228|<|0.001|TWO_SIDED|95.0|-1.51|-0.61|||Mixed Models Analysis|||||-0.61|-1.51|<0.001
71050705|NCT00546572|141608006|SUPERIORITY_OR_OTHER||difference in proportions|-17.1|||<|0.001|TWO_SIDED|95.0|-23.1|-11.1|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Limitation of arm movement: any; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-11.1|-23.1|<0.001
71105225|NCT02255435|141717682|SUPERIORITY||LS Mean difference (Net)|-2.3||||0.0587|TWO_SIDED|95.0|-4.68|0.09|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||0.09|-4.68|0.0587
70931246|NCT00115934|141362479|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-10.1||||0.013||95.0|-17.8|-2.4|||Fisher Exact||The risk difference is defined as the percent of subjects with events in the RVPAS group minus the percent of subjects with events in the MBTS group.|The original sample size of 456 was based on 85% power, with a two-sided, two sample test of proportions (anticipating 28% MBTS subjects with events, 16% RVPAS subjects with events), and an alpha of 0.05. The critical p-value was 0.044 because four interim analyses were performed. The target trial size was increased from 466 to 554 to account for crossovers. The stopping boundary was crossed at the 4th interim look; however, the trial was not halted, because all subjects were enrolled.||-2.4|-17.8|0.013
70931247|NCT00115934|141362480|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06||95.0|||||Log Rank|||||||0.06
70931248|NCT00115934|141362481|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.09
70931249|NCT00115934|141362482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.009
70931250|NCT00115934|141362483|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.07
71105226|NCT02255435|141717682|SUPERIORITY||LS Mean difference (Net)|0.58||||0.648|TWO_SIDED|95.0|-1.94|3.1|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||3.10|-1.94|0.6480
70931251|NCT00115934|141362484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.001
70931252|NCT00115934|141362485|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank-sum test||||0.004
71017079|NCT03692078|141541638|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.751|||<|0.0001|TWO_SIDED|95.0|2.651|2.851|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||2.851|2.651|<.0001
71017080|NCT03692078|141541638|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.819|||<|0.0001|TWO_SIDED|95.0|2.718|2.919|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||2.919|2.718|<.0001
71017081|NCT03692078|141541638|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.173||||0.0377|TWO_SIDED|95.0|-0.34|-0.006|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.006|-0.340|0.0377
71017082|NCT03692078|141541638|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.163||||0.0643|TWO_SIDED|95.0|-0.331|0.006|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||0.006|-0.331|0.0643
71017083|NCT03692078|141541638|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.112||||0.3875|TWO_SIDED|95.0|-0.279|0.056|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.056|-0.279|0.3875
71017084|NCT03692078|141541638|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.113||||0.3725|TWO_SIDED|95.0|-0.28|0.054|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.054|-0.280|0.3725
71050706|NCT00546572|141608006|SUPERIORITY_OR_OTHER||difference in proportions|-14.9|||<|0.001|TWO_SIDED|95.0|-20.8|-9.0|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Limitation of arm movement: mild; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-9.0|-20.8|<0.001
70931253|NCT00115934|141362486|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.10
70931254|NCT00115934|141362487|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
70931255|NCT00115934|141362488|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07||95.0|||||t-test, 2 sided|||||||0.07
70931256|NCT00115934|141362489|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97||95.0|||||t-test, 2 sided|||||||0.97
70931257|NCT00115934|141362490|SUPERIORITY_OR_OTHER_LEGACY|||||||0.54||95.0|||||t-test, 2 sided|||||||0.54
70931258|NCT00115934|141362491|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
70931259|NCT00115934|141362492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0|||||Poisson regression|The offset parameter used in the poisson regression was the log of the number of patients in each treatment arm.||||||0.003
70941587|NCT02005029|141383900|SUPERIORITY_OR_OTHER||Erythromycin:Placebo AUC ratio|1.07|STANDARD_DEVIATION|0.43|||TWO_SIDED|||||||||||||
70931260|NCT00115934|141362493|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||95.0|||||Poisson Regression|The offset parameter used in this analysis was the log of the number of patients per treatment arm.||||||0.20
70931261|NCT00115934|141362494|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||Poisson Regression|The offset parameter used in this analysis was the log of the number of patients per treatment arm.||||||0.002
70931262|NCT00115934|141362495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0|||||Poisson regression|The offset parameter used in this analysis was the log of the number of patients per treatment arm.||||||0.03
70931263|NCT00754065|141362511|SUPERIORITY_OR_OTHER_LEGACY||F-statistic|9.3218||||0.0024||||||Comparison of EV/DNG vs. EE/NGM|ANOVA|||2-way ANOVA model with treatment and pain strata (headache and pelvic pain) as factors||||0.0024
71105227|NCT02255435|141717682|SUPERIORITY||LS Mean difference (Net)|-1.1||||0.2174|TWO_SIDED|95.0|-2.87|0.66|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|Comparison of Omaveloxolone capsules pooled with Placebo capsules||0.66|-2.87|0.2174
70931264|NCT03776812|141362628|OTHER||Hazard Ratio (HR)|0.83||||0.3293|TWO_SIDED|95.0|0.56|1.22|||Cox proportional hazards model|||||1.22|0.56|0.3293
70931265|NCT03776812|141362628|OTHER||Hazard Ratio (HR)|0.66||||0.0384|TWO_SIDED|95.0|0.44|0.98|||Cox proportional hazards model|||||0.98|0.44|0.0384
70931266|NCT06688357|141362655|SUPERIORITY||Cohen's d|0.99||||0.077|TWO_SIDED|||||t (13) = 1.920. Only 1 comparison with 2 means, thus no adjustment necessary|t-test, 2 sided|||Independent sample t-test conducted to examine difference in pre-post intervention change scores for the active vs sham intervention groups. Cohen's d was calculated to determine effect size.||||.077
70931267|NCT06688357|141362656|SUPERIORITY||Cohen's D|0.779||||0.159|TWO_SIDED|||||t(13) = 1.504; only 1 comparison of 2 values, thus no adjustment is necessary|t-test, 2 sided|||independent sample t-test; Cohen's d effect size||||.159
70931268|NCT06688357|141362657|SUPERIORITY||Cohen's D|0.356||||0.503|TWO_SIDED|||||t (13) = 0.688; only 1 comparison, adjustment not necessary|t-test, 2 sided|df = 13||independent samples t-test, cohen's d effect size||||.503
70931269|NCT06688357|141362658|SUPERIORITY||Cohen's D|-0.922||||0.08|TWO_SIDED|||||t(13) = 1.893; only one comparison of 2 scores, thus no adjustment for multiple comparisons was necessary|t-test, 2 sided|df = 13||Independent sample t-test used to examine pre-post intervention change scores in active vs sham groups; Cohen's d was calculated to estimate effect size||||0.08
70931270|NCT06688357|141362659|SUPERIORITY||Cohen's D|0.793||||0.149|TWO_SIDED|||||t (13) = 1.533; only 1 comparison, no adjustment necessary|t-test, 2 sided|||independent sample t-test, Cohen d effect size||||.149
70931271|NCT06688357|141362660|SUPERIORITY||Cohen's D|0.905||||0.104|TWO_SIDED|||||t(13) = 1.749; only 1 comparison with 2 values, thus no adjustment for multiple comparisons|t-test, 2 sided|df = 13||independent sample t-test was used to examine difference in Post-Pre intervention change in the Active vs the Sham groups; Effect size was estimated using Cohen's d.||||.104
70931272|NCT06688357|141362661|SUPERIORITY||Cohen's D|-0.267||||0.614|TWO_SIDED|||||t(13) = -.516; only 1 comparison of 2 means, no adjustment needed|t-test, 2 sided|||independent sample t-tests examining Post-Baseline differences for the Active vs the Sham groups; Effect size computed using Cohen's d score||||.614
70931273|NCT06688357|141362662|SUPERIORITY||Cohen's D|0.652||||0.23|TWO_SIDED|||||t(13) = -1.260; only 1 comparison of 2 values, no need for adjustment|t-test, 2 sided|||independent samples t-test, effect size computation (cohen's d)||||.230
70931274|NCT02879318|141362663|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.72|TWO_SIDED|90.0|0.71|1.25||a priori threshold for statistical significance was 0.1.|Log Rank|stratified by ECOG performance status and prior adjuvant therapy.||||1.25|0.71|0.72
70931275|NCT02879318|141362664|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.91|TWO_SIDED|90.0|0.75|1.29|||Log Rank|||||1.29|0.75|0.91
70931276|NCT02879318|141362665|SUPERIORITY||Odds Ratio (OR)|1.49||||0.28|TWO_SIDED|90.0|0.81|2.72|||Cochran-Mantel-Haenszel|stratified by ECOG performance status and prior adjuvant chemotherapy||||2.72|0.81|0.28
70931277|NCT01084863|141362671|EQUIVALENCE|Pharmacokinetic equivalence was predefined based on acceptance criteria, 80% to 125%.|Geometric Mean Ratio|104.57|||||TWO_SIDED|90.0|93.64|116.78||||||||116.78|93.64|
70931278|NCT03275285|141362695|SUPERIORITY|For PFS, the nominal significance levels at primary analysis was determined using alpha-spending function in order to control overall 1-sided type 1 error at 2.5%. The 1-sided nominal significance level to declare overwhelming efficacy at primary analysis (103 PFS events) was 0.005. Because the median PFS was not reached at the primary analysis, it was described at the final analysis.|Hazard Ratio (HR)|0.531||||0.0007|TWO_SIDED|99.0|0.318|0.889||One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.005.|Stratified Log-Rank test|Stratified on number of prior lines of therapy (1 vs \>1) \& revised international staging system stage (I/II vs III vs not classified) as per IRT.|Hazard Ratio was stratified on number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|Statistical analysis for comparison of PFS between the Kd and IKd arms based on primary analysis.||0.889|0.318|0.0007
70931279|NCT03275285|141362696|SUPERIORITY|The 1-sided nominal significance level to declare overwhelming efficacy at primary analysis was 0.004. Because the median PFS was not reached at the primary analysis, it was described at the final analysis.|Hazard Ratio (HR)|0.548||||0.0016|TWO_SIDED|99.2|0.317|0.948||One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.004.|Stratified Log-Rank test|Stratified on number of prior lines of therapy (1 vs \>1) \& revised international staging system stage (I/II vs III vs not classified) as per IRT.|Hazard Ratio was stratified on number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|Statistical analysis for comparison of PFS between the Kd and IKd arm based on primary analysis.||0.948|0.317|0.0016
70931280|NCT03275285|141362697|SUPERIORITY||Hazard Ratio (HR)|0.576|||||TWO_SIDED|95.4|0.418|0.792|||||Hazard Ratio was stratified on number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|||0.792|0.418|
70931281|NCT03275285|141362698|SUPERIORITY||Hazard Ratio (HR)|0.594|||||TWO_SIDED|95.4|0.424|0.832|||||Hazard Ratio was stratified on number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|||0.832|0.424|
70941588|NCT02005029|141383901|SUPERIORITY_OR_OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.65
70941589|NCT02005029|141383902|SUPERIORITY_OR_OTHER|||||||0.18|||||||t-test, 2 sided|||||||0.18
70941590|NCT02005029|141383903|SUPERIORITY_OR_OTHER|||||||0.4405|||||||t-test, 2 sided|||||||0.4405
70941591|NCT02005029|141383904|SUPERIORITY_OR_OTHER|||||||0.6011|||||||t-test, 2 sided|||||||0.6011
70850919|NCT00621348|141190076|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis|Risk Ratio (RR)|0.12|STANDARD_ERROR_OF_MEAN|0.0|<|0.05|TWO_SIDED|95.0|0.016|0.93||p value was adjusted for multiple comparisons.|Fisher Exact||The risk ratio is for Group A compared with Group C.|The incidence of hospital-acquired hyponatremia with current standard intravenous fluid therapy was approximately 30%. Sample of 72 patients would be needed in each group to demonstrate the decrease in incidence of hyponatremia (defined as plasma sodium\< 130 mEq/L) to 10%, with a power of 80 percent and alpha error of 0.05. In view of short study period and feasibility it was planned a priori to enroll at least 50 patients in each treatment limb.||0.93|0.016|<0.05
71050707|NCT00546572|141608006|SUPERIORITY_OR_OTHER||difference in proportions|-2.3||||0.02|TWO_SIDED|95.0|-4.8|-0.4|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Limitation of arm movement: moderate; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-0.4|-4.8|0.020
70850920|NCT03120351|141190080|SUPERIORITY||Mean Difference (Net)|-2.5||||0.28|TWO_SIDED|95.0|-7.11|2.06|||Mixed Models Analysis|||||2.06|-7.11|0.28
70850921|NCT01256190|141190081|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
70850922|NCT01256190|141190082|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||t-test, 2 sided|||||||0.31
70850923|NCT01256190|141190083|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Fisher Exact|||intent-to-treat analysis||||.022
70850924|NCT01256190|141190084|SUPERIORITY_OR_OTHER|||||||0.113||95.0|||||Fisher Exact|||intent-to treat analysis||||0.113
70850925|NCT01256190|141190085|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||Fisher Exact|||intent-to-treat analysis||||.025
70850926|NCT02834793|141190086|SUPERIORITY||Median Difference (Net)|-19.3|||=|0.107|TWO_SIDED|95.0|-49.2|4.8||The p-value was based on a rank analysis of covariance (ANCOVA) with treatment, region, and age-group as factors, and prerandomization drop seizure frequency as a covariate.|ANCOVA||The median difference to placebo and the 95 percent (%) confidence interval (CI) were based on the Hodges-Lehmann method.|||4.8|-49.2|= 0.107
70850927|NCT02197078|141190111|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.66|1.03||||||||1.03|0.66|
70850928|NCT02197078|141190111|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.65|1.1||||||||1.10|0.65|
70850929|NCT02197078|141190111|OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.49|0.86||||||||0.86|0.49|
70850930|NCT02197078|141190111|OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.83|1.1||||||||1.10|0.83|
70850931|NCT02197078|141190111|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.85|1.19||||||||1.19|0.85|
70850932|NCT02197078|141190111|OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.66|0.96||||||||0.96|0.66|
70850933|NCT02197078|141190112|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.66|1.23||||||||1.23|0.66|
70850934|NCT02197078|141190112|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.57|1.16||||||||1.16|0.57|
70850935|NCT02197078|141190112|OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.48|1.01||||||||1.01|0.48|
70850936|NCT02197078|141190112|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.85|1.28||||||||1.28|0.85|
70850937|NCT02197078|141190112|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.79|1.28||||||||1.28|0.79|
70850938|NCT02197078|141190112|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.62|1.06||||||||1.06|0.62|
70850939|NCT02197078|141190113|OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.51|0.94||||||||0.94|0.51|
70850940|NCT02197078|141190113|OTHER||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.44|0.9||||||||0.90|0.44|
70850941|NCT02197078|141190113|OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.41|0.88||||||||0.88|0.41|
70850942|NCT02197078|141190113|OTHER||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.81|1.17||||||||1.17|0.81|
70850943|NCT02197078|141190113|OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.77|1.19||||||||1.19|0.77|
70850944|NCT02197078|141190113|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.6|0.97||||||||0.97|0.60|
70850945|NCT02197078|141190114|OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.58|1.38||||||||1.38|0.58|
70850946|NCT02197078|141190114|OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.6|1.64||||||||1.64|0.60|
70850947|NCT02197078|141190114|OTHER||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.24|0.78||||||||0.78|0.24|
70850948|NCT02197078|141190114|OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.73|1.25||||||||1.25|0.73|
70850949|NCT02197078|141190114|OTHER||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.78|1.52||||||||1.52|0.78|
70850950|NCT02197078|141190114|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.52|1.05||||||||1.05|0.52|
70850951|NCT02197078|141190115|OTHER||Hazard Ratio (HR)|1.55|||||TWO_SIDED|95.0|1.1|2.18||||||||2.18|1.10|
70850952|NCT02197078|141190115|OTHER||Hazard Ratio (HR)|1.9|||||TWO_SIDED|95.0|1.19|3.03||||||||3.03|1.19|
70850953|NCT02197078|141190115|OTHER||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.73|1.68||||||||1.68|0.73|
70850954|NCT02197078|141190115|OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.76|1.29||||||||1.29|0.76|
70850955|NCT02197078|141190115|OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.77|1.56||||||||1.56|0.77|
70850956|NCT02197078|141190115|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.54|1.14||||||||1.14|0.54|
70850957|NCT02197078|141190116|OTHER||Hazard Ratio (HR)|1.4|||||TWO_SIDED|95.0|0.97|2.0||||||||2.00|0.97|
70850958|NCT02197078|141190116|OTHER||Hazard Ratio (HR)|1.71|||||TWO_SIDED|95.0|1.07|2.72||||||||2.72|1.07|
70850959|NCT02197078|141190116|OTHER||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.75|1.79||||||||1.79|0.75|
70850960|NCT02197078|141190116|OTHER||Hazard Ratio (HR)|1.34|||||TWO_SIDED|95.0|1.01|1.76||||||||1.76|1.01|
70850961|NCT02197078|141190116|OTHER||Hazard Ratio (HR)|1.52|||||TWO_SIDED|95.0|1.02|2.27||||||||2.27|1.02|
70850962|NCT02197078|141190116|OTHER||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.81|1.71||||||||1.71|0.81|
70850963|NCT02197078|141190117|OTHER||Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|1.04|1.47||||||||1.47|1.04|
70850964|NCT02197078|141190117|OTHER||Hazard Ratio (HR)|1.31|||||TWO_SIDED|95.0|1.06|1.61||||||||1.61|1.06|
70931282|NCT03275285|141362699|SUPERIORITY|A closed test procedure was used to control the Type I error rate from the primary efficacy endpoints sequentially through the secondary efficacy endpoints. No further testing would be performed unless the significance level had been reached on PFS and testing on subsequent endpoints were continued only if the null hypothesis for the previously tested endpoint was rejected.||||||0.193||||||One-sided p-value based on Stratified Cochran-Mantel-Haenszel test. Threshold for statistical significance level at 0.025.|Cochran-Mantel-Haenszel|One sided p-value was stratified based on randomization factors according to IRT.||Statistical analysis for comparison of Overall Response between the Kd and IKd arms based on primary analysis.||||0.1930
70931283|NCT03275285|141362706|SUPERIORITY||Stratified Hazard Ratio|0.425|||||TWO_SIDED|95.0|0.269|0.672|||||Stratification was done on the number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|||0.672|0.269|
70931284|NCT03275285|141362707|SUPERIORITY||Stratified Hazard Ratio|0.495|||||TWO_SIDED|95.0|0.324|0.757|||||Stratification was done on the number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|||0.757|0.324|
71017085|NCT03692078|141541638|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.516|||<|0.0001|TWO_SIDED|95.0|-0.706|-0.327|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.327|-0.706|<.0001
71017086|NCT03692078|141541638|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.611|||<|0.0001|TWO_SIDED|95.0|-0.802|-0.42|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.420|-0.802|<.0001
71017087|NCT03692078|141541638|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.573|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.386|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.386|-0.760|<.0001
71017088|NCT03692078|141541638|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.613|||<|0.0001|TWO_SIDED|95.0|-0.803|-0.423|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.423|-0.803|<.0001
71017089|NCT03692078|141541638|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.369|||<|0.0001|TWO_SIDED|95.0|0.19|0.548|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||0.548|0.190|<.0001
71017090|NCT03692078|141541638|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.28||||0.0003|TWO_SIDED|95.0|0.099|0.462|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||0.462|0.099|0.0003
71017091|NCT03692078|141541638|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.431|||<|0.0001|TWO_SIDED|95.0|0.251|0.611|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||0.611|0.251|<.0001
70941592|NCT02005029|141383905|SUPERIORITY_OR_OTHER|||||||0.8923|||||||t-test, 2 sided|||||||0.8923
70941593|NCT02005029|141383906|SUPERIORITY_OR_OTHER|||||||0.832|||||||t-test, 2 sided|||||||0.832
70931285|NCT03275285|141362708|SUPERIORITY||Stratified Hazard Ratio|1.143|||||TWO_SIDED|95.0|0.888|1.471|||||||Stratification was done on the number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|1.471|0.888|
70931286|NCT03275285|141362709|SUPERIORITY||Stratified Hazard Ratio|0.955|||||TWO_SIDED|95.0|0.74|1.233|||||Stratification was done on the number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|||1.233|0.740|
70850965|NCT02197078|141190117|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.84|1.29||||||||1.29|0.84|
70850966|NCT02197078|141190117|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.91|1.19||||||||1.19|0.91|
70850967|NCT02197078|141190117|OTHER||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.9|1.27||||||||1.27|0.90|
70850968|NCT02197078|141190117|OTHER||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.75|1.09||||||||1.09|0.75|
70850969|NCT02197078|141190118|OTHER||Hazard Ratio (HR)|1.62|||||TWO_SIDED|95.0|0.64|4.06||||||||4.06|0.64|
70850970|NCT02197078|141190118|OTHER||Hazard Ratio (HR)|1.67|||||TWO_SIDED|95.0|0.61|4.58||||||||4.58|0.61|
70850971|NCT02197078|141190118|OTHER||Hazard Ratio (HR)|1.84|||||TWO_SIDED|95.0|0.62|5.48||||||||5.48|0.62|
70850972|NCT02197078|141190118|OTHER||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.57|2.4||||||||2.40|0.57|
70850973|NCT02197078|141190118|OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.38|2.43||||||||2.43|0.38|
70850974|NCT02197078|141190118|OTHER||Hazard Ratio (HR)|1.65|||||TWO_SIDED|95.0|0.64|4.27||||||||4.27|0.64|
70850975|NCT00622440|141190119|OTHER||Wilcoxon Rank Sum Effect Size|0.275||||0.042|TWO_SIDED|95.0|||||Wilcoxon rank sum||The wilcoxon rank sum effect size ranges in strength of effect from small (0.10 - \< 0.30), to medium (0.30 - \< 0.50), to large (\>=0.50) with a total range of 0 to 1|Estimated Effect Size for Phase 3 Trial||||.042
70850976|NCT00332722|141190175|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired t test|||||||<0.05
70850977|NCT00332722|141190176|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired t test|||||||<0.05
70850978|NCT00918736|141190181|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Previous report using 5 weekly injections, mean AOS score reduction is 2.6 with the SD of 1.8 in 75 patients. To test whether AOS reduction would be \> 1 using pair t-test after 3 weekly injections, investigators need \> 42 patients to give \> 90% power to reject the null hypothesis-mean AOS score reduction \<1 at 6 months, given that both the mean and standard deviation of AOS score reduction equal to 2. Considering possible dropout of participants, investigators decide to include 50 patients||||<0.05
70850979|NCT01474018|141190188|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED||||||ANOVA|||||||0.004
70850980|NCT01474018|141190189|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED||||||ANOVA|||||||0.01
70850981|NCT01474018|141190189|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED||||||ANOVA|||||||0.009
70850982|NCT02511106|141190203|SUPERIORITY||Hazard Ratio (HR)|0.23|||<|0.0001|TWO_SIDED|95.0|0.18|0.3|||Log Rank|Determined using a log rank test stratified by stage, race and mutation type.|A hazard ratio \<1 favours AZD9291.|||0.30|0.18|<0.0001
70850983|NCT02511106|141190204|SUPERIORITY||Hazard Ratio (HR)|0.27|||<|0.0001|TWO_SIDED|95.0|0.21|0.34|||Log Rank|Determined using a log rank test stratified by stage, race and mutation type.|A hazard ratio \<1 favours AZD9291.|||0.34|0.21|<0.0001
70850984|NCT02511106|141190207|SUPERIORITY||Hazard Ratio (HR)|0.4913||||0.0004|TWO_SIDED|95.03|0.3307|0.7299|||Log Rank|Determined using a log rank test stratified by stage, race and mutation type.|A hazard ratio \<1 favours AZD9291.|||0.7299|0.3307|0.0004
70850985|NCT02511106|141190208|SUPERIORITY||Hazard Ratio (HR)|0.4912|||<|0.0001|TWO_SIDED|95.03|0.3439|0.7017|||Log Rank|Determined using a log rank test stratified by stage, race and mutation type.|A hazard ratio \<1 favours AZD9291.|||0.7017|0.3439|<0.0001
70850986|NCT03679754|141190243|OTHER||||||||||||||||||Subjects in the Expansion trial did not have biopsies analyzed for cellular responses.|||
70850987|NCT00711477|141190250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|||||TWO_SIDED|90.0|0.5|0.9||||||||0.90|0.50|
70850988|NCT00711477|141190251|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56||||0.38|TWO_SIDED|95.0|-1.83|0.72|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline||||0.72|-1.83|0.380
70850989|NCT00711477|141190252|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.744|TWO_SIDED|95.0|-2.87|2.07|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline||||2.07|-2.87|0.744
70850990|NCT00711477|141190253|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.64||||0.139|TWO_SIDED|95.0|-3.84|0.56|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline||||0.56|-3.84|0.139
70850991|NCT00711477|141190254|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.36||||0.094|TWO_SIDED|95.0|-2.96|0.24|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline||||0.24|-2.96|0.094
70850992|NCT00711477|141190255|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.48||||0.102|TWO_SIDED|95.0|-5.48|0.51|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline||||0.51|-5.48|0.102
70850993|NCT00711477|141190256|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.4||||0.16||95.0|-22.7|3.89|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline||||3.89|-22.7|0.160
70850994|NCT00711477|141190257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|90.0|0.4|0.8||||||||0.80|0.40|
70850995|NCT00711477|141190258|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.75|||||TWO_SIDED|90.0|0.5|1.0||||||||1.00|0.50|
70850996|NCT00711477|141190259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99|||||TWO_SIDED|90.0|0.74|1.24||||||||1.24|0.74|
70850997|NCT00711477|141190260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|||||TWO_SIDED|90.0|0.95|1.65||||||||1.65|0.95|
70850998|NCT00711477|141190261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|||||TWO_SIDED|90.0|0.31|0.57||||||||0.57|0.31|
70850999|NCT01640834|141190268|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.84||||0.0542|TWO_SIDED|95.0|-11.82|0.14|||t-test, 1 sided|||The mean change on Day 2 from Day 1 in the 24-hour insulin dose for the placebo group was subtracted from each participant's change on Day 2 from Day 1 in the 24-hour insulin dose. This placebo adjusted 24-hour insulin dose was compared within the 100-mg LY2409021 dose group using a 1 sample t-test.||0.14|-11.82|0.0542
70931287|NCT03275285|141362710|SUPERIORITY|\[Not specified\]|[Stratified Hazard Ratio]|0.683|||||TWO_SIDED|95.0|0.496|0.941|||||Stratification was done on the number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|\[Not specified\]||0.941|0.496|
70931288|NCT03275285|141362711|SUPERIORITY|\[Not specified\]|Stratified Hazard Ratio|0.663|||||TWO_SIDED|95.0|0.491|0.895|||||Stratification was done on the number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|\[Not specified\]||0.895|0.491|
70931289|NCT03211247|141362758|OTHER||Proportion difference|33.4|||<|0.001|TWO_SIDED|95.0|22.36|44.49|||Wald test||The 2-sided Farrington-Manning 95% confidence interval for the difference in response rates was calculated.|Analysis of the difference in response rates between DBV712 250 μg group and Placebo group and 2-sided Farrington-Manning 95% confidence interval (CI). P-value was obtained from a 2-sided 5% test to evaluate the null hypothesis of no difference in response rates between treatment groups using the Wald method. Clinical relevance was evaluated based on the lower bound of the Farrignton-Manning 95% CI of the difference in response rates ≥15%.||44.49|22.36|<0.001
70931290|NCT00353496|141362797|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.47|||<|0.001|TWO_SIDED|95.0|0.3|0.73||No p-value adjustment for multiple comparisons.|Log Rank|The log rank test was stratified according to progression status at baseline and prior therapy.||||0.73|0.30|<0.001
70931291|NCT02278185|141362831|SUPERIORITY|||||||0.46|||||||Chi-squared|||The difference between metabolic syndrome and treatment were evaluated with the Chi-square test|This study did not meet it's target accrual goal and thus is underpowered to detect a statistically significant difference between the two groups.|||0.46
70931292|NCT02278185|141362831|SUPERIORITY|||||||0.46|||||||Chi-squared|||Cohort characteristics for Metabolic Syndrome were summarized by event and arm using counts and percentages for categorical variables and the mean, standard deviation, median, and quartiles for continuous variables. The difference between metabolic syndrome and treatment were evaluated with the Chi-square test. P-values are reported based on a null hypothesis of no difference against a two-sided alternative. Analyses were performed using SAS 9.4 (SAS Inst|Cohort characteristics for Metabolic Syndrome, the SPPB, the SHIM/FACT-P, and PSA were summarized by event and arm using counts and percentages for categorical variables and the mean, standard deviation, median, and quartiles for continuous variables. The difference between metabolic syndrome and treatment were evaluated with the Chi-square test. The Wilcoxon signed-rank test was utilized to examine the difference between Month 1 and Month 12 SPPB scores. The Wilcoxon rank-sum test was used to assess the difference of SHIM/FACT-P scores and PSA between arms. These tests were chosen to account for the non-normal distributions of the continuous variables. The difference between PSA progression between arms was examined using the Fisher Exact Test. A heat map of scores ordered by the highest average score was also created. P-values are reported based on a null hypothesis of no difference against a two-sided alternative. Analyses were performed using SAS 9.4 (SAS Inst|||0.46
70931293|NCT02278185|141362842|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||The results are presented in the following format: N Mean (Std Dev) Median (Q1, Q3). In all cases (Overall, Arm 1, and Arm 2) we fail to reject the null hypothesis that the samples come from the same population of scores at Month 1 versus Month 12 at the 0.05 significance level.||||0.5
70931294|NCT01074294|141362854|SUPERIORITY||Mean Difference (Final Values)|0.69||||0.5845|TWO_SIDED|95.0|-1.8|3.19||The p-value was derived using MMRM method with treatment, trial center, visit week, and treatment by visit week interaction as class effects and Week 5 value as covariate.|Mixed Models Analysis||The difference between Least Squares (LS) means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||3.19|-1.80|0.5845
70931295|NCT01074294|141362855|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.8832|TWO_SIDED|95.0|-1.37|1.18||The p-value was derived using ANCOVA model with treatment and trial center as main effects and Week 5 value as covariate.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||1.18|-1.37|0.8832
70931296|NCT01074294|141362856|SUPERIORITY||Mean Difference (Final Values)|0.57||||0.3864|TWO_SIDED|95.0|-0.72|1.86||The p-value was derived using MMRM method with treatment, trial center, visit week, and treatment by visit week interaction as class effects and Week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||1.86|-0.72|0.3864
70931297|NCT01074294|141362857|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.0061|TWO_SIDED|95.0|0.1|0.58||The p value was derived using MMRM method with treatment, trial center, visit week, and treatment by visit week interaction as class effects and Week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.58|0.10|0.0061
70931298|NCT01074294|141362858|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.6932|TWO_SIDED|95.0|-1.64|2.46||The p-value was derived from ANCOVA model, with treatment and trial center as main effects and Week 5 value as covariate.|ANCOVA||This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||2.46|-1.64|0.6932
70931299|NCT01074294|141362859|SUPERIORITY||Mean Difference (Final Values)|0.81||||0.2781|TWO_SIDED|95.0|-0.66|2.28||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||2.28|-0.66|0.2781
70931300|NCT01074294|141362859|SUPERIORITY||Mean Difference (Final Values)|0.67||||0.4673|TWO_SIDED|95.0|-1.15|2.49||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||2.49|-1.15|0.4673
71105228|NCT01664624|141717707|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|5.82||0.388|TWO_SIDED|95.0|-16.9|6.7||The comparison was evaluated at the 5% level of significance.|ANCOVA|ANCOVA model with treatment as fixed effect, and baseline Postprandial AUC (0-8) of active GLP-1 as a continuous covariate.||ANCOVA was used to test the null hypothesis that the change from Baseline in the postprandial AUC(0-8) of active GLP-1 is no difference between the roflumilast + alogliptin and alogliptin alone.||6.7|-16.9|0.388
71105229|NCT01664624|141717707|SUPERIORITY_OR_OTHER||LS Mean Difference|22.7|STANDARD_ERROR_OF_MEAN|5.7|<|0.001|TWO_SIDED|95.0|11.1|34.3||The comparison was evaluated at the 5% level of significance.|ANCOVA|ANCOVA model with treatment as fixed effect, and Baseline Postprandial AUC (0-8) of active GLP-1 as a continuous covariate.||ANCOVA was used to test the null hypothesis that the change from Baseline in the postprandial AUC(0-8) of active GLP-1 is no difference between the roflumilast + alogliptin and roflumilast alone.||34.3|11.1|<0.001
70931301|NCT01074294|141362859|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.5719|TWO_SIDED|95.0|-1.54|2.79||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||2.79|-1.54|0.5719
70931302|NCT01074294|141362859|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.6262|TWO_SIDED|95.0|-1.7|2.83||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||2.83|-1.70|0.6262
70931303|NCT01074294|141362859|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.2638|TWO_SIDED|95.0|-1.06|3.87||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||3.87|-1.06|0.2638
70931304|NCT01074294|141362860|SUPERIORITY||Mean Difference (Final Values)|0.42||||0.3804|TWO_SIDED|95.0|-0.52|1.37||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||1.37|-0.52|0.3804
70931305|NCT01074294|141362860|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.6422|TWO_SIDED|95.0|-0.86|1.39||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.39|-0.86|0.6422
71017092|NCT03692078|141541638|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.33|||<|0.0001|TWO_SIDED|95.0|0.149|0.511|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||0.511|0.149|<.0001
71017093|NCT03692078|141541638|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.026||||1|TWO_SIDED|95.0|-0.176|0.228|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.228|-0.176|1.0000
71017094|NCT03692078|141541638|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.168||||0.1589|TWO_SIDED|95.0|-0.371|0.036|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.036|-0.371|0.1589
71017095|NCT03692078|141541638|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.031||||0.9999|TWO_SIDED|95.0|-0.23|0.168|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.168|-0.230|0.9999
71017096|NCT03692078|141541638|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.17||||0.1453|TWO_SIDED|95.0|-0.372|0.032|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.032|-0.372|0.1453
71050708|NCT00546572|141608006|SUPERIORITY_OR_OTHER||difference in proportions|-2.3||||0.042|TWO_SIDED|95.0|-4.9|-0.1|||Limitation of arm movement: any; differe||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Limitation of arm movement: severe; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-0.1|-4.9|0.042
71105230|NCT01664624|141717707|SUPERIORITY_OR_OTHER||LS Mean Difference|28.8|STANDARD_ERROR_OF_MEAN|5.76|<|0.001|TWO_SIDED|95.0|17.1|40.5||The comparison was evaluated at the 5% level of significance.|ANCOVA|ANCOVA model with treatment as fixed effect, and Baseline Postprandial AUC (0-8) of active GLP-1 as a continuous covariate.||ANCOVA was used to test the null hypothesis that the change from Baseline in the postprandial AUC(0-8) of active GLP-1 is no difference between the roflumilast + alogliptin and roflumilast alone.||40.5|17.1|<0.001
70851000|NCT01640834|141190268|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.89||||0.0826|TWO_SIDED|95.0|-14.95|1.16|||t-test, 1 sided|||The mean change on Day 2 from Day 1 in the 24-hour insulin dose for the placebo group was subtracted from each participant's change on Day 2 from Day 1 in the 24-hour insulin dose. This placebo adjusted 24-hour insulin dose was compared within the 300-mg LY2409021 dose group.||1.16|-14.95|0.0826
70941594|NCT02005029|141383907|SUPERIORITY_OR_OTHER|||||||0.1546|||||||t-test, 2 sided|||||||0.1546
71105231|NCT00127439|141717713|NON_INFERIORITY_OR_EQUIVALENCE|The power analysis indicated that when the mean difference equals to 1.2 times of standard deviation, a two-sided t-test at 0.05 level will have 80% power; and for a mean difference of 1.4 times of standard deviation the power increases to 91%. To test the null hypothesis that correlation will be 0 at 0.5 level, a two-sided test based on Fisher's Z transformation will yield a power of 89% in detecting correlations of 0.6 or above with n=24 or above.||||||0.05|||||||t-test, 2 sided|||||||0.05
71050709|NCT00546572|141608011|SUPERIORITY_OR_OTHER||difference in proportions|-7.9||||0.034|TWO_SIDED|95.0|-15.2|-0.6|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|New generalized muscle pain: difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-0.6|-15.2|0.034
71050710|NCT00546572|141608011|SUPERIORITY_OR_OTHER||difference in proportions|-6.9||||0.039|TWO_SIDED|95.0|-13.6|-0.3|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Aggravated generalized muscle pain: difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-0.3|-13.6|0.039
71050711|NCT01394952|141608016|SUPERIORITY|"Superiority was declared if the upper limit of the 2-sided 95.33% confidence interval (CI) of the hazard ratio was below 1.0 (after adjustment for the interim analysis).~Once superiority was achieved for the primary endpoint, multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467."|Hazard Ratio (HR)|0.88||||0.026|TWO_SIDED|95.33|0.79|0.99|||Regression, Cox|||Primary CV endpoint||0.99|0.79|0.026
71050712|NCT01394952|141608017|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.91||||0.211|TWO_SIDED|95.0|0.78|1.06|||Regression, Cox|||Death from CV causes||1.06|0.78|0.211
71050713|NCT01394952|141608017|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.96||||0.652|TWO_SIDED|95.0|0.79|1.16|||Regression, Cox|||Nonfatal MI||1.16|0.79|0.652
71050714|NCT01394952|141608017|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.76||||0.017|TWO_SIDED|95.0|0.61|0.95|||Regression, Cox|||Nonfatal stroke||0.95|0.61|0.017
71050715|NCT01394952|141608018|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.9||||0.067|TWO_SIDED|95.0|0.8|1.01|||Regression, Cox|||Time to all cause mortality||1.01|0.80|0.067
71050716|NCT01394952|141608019|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.86|||<|0.001|TWO_SIDED|95.0|0.79|0.93|||Regression, Cox|||microvascular endpoint||0.93|0.79|<0.001
71050717|NCT01394952|141608020|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.93||||0.456|TWO_SIDED|95.0|0.77|1.12|||Regression, Cox|||Heart failure requiring hospitalization or an urgent heart failure clinic visit||1.12|0.77|0.456
71050718|NCT01394952|141608021|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|1.14||||0.413|TWO_SIDED|95.0|0.84|1.54|||Regression, Cox|||Hospitalization for unstable angina||1.54|0.84|0.413
71050719|NCT01986010|141608029|OTHER||GMT Ratio|1.5|||||TWO_SIDED|95.0|0.8|2.6||||||GMT Ratio: GMT V160/GMT placebo||2.6|0.8|
71050720|NCT01986010|141608029|OTHER||GMT Ratio|1.9|||||TWO_SIDED|95.0|1.1|3.2||||||GMT Ratio: GMT V160/GMT placebo||3.2|1.1|
71050721|NCT01986010|141608029|OTHER||GMT Ratio|3.5|||||TWO_SIDED|95.0|1.6|7.4||||||GMT Ratio: GMT V160/GMT placebo||7.4|1.6|
71050722|NCT01986010|141608029|OTHER||GMT Ratio|2.6|||||TWO_SIDED|95.0|1.4|4.6||||||GMT Ratio: GMT V160/GMT placebo||4.6|1.4|
71050723|NCT01986010|141608029|OTHER||GMT Ratio|1.6|||||TWO_SIDED|95.0|0.9|3.0||||||GMT Ratio: GMT V160/GMT placebo||3.0|0.9|
71050724|NCT01986010|141608029|OTHER||GMT Ratio|3.9|||||TWO_SIDED|95.0|2.2|7.0||||||GMT Ratio: GMT V160/GMT placebo||7.0|2.2|
71050725|NCT01986010|141608029|OTHER||GMT Ratio|16.4|||<|0.001|TWO_SIDED|95.0|9.5|28.4||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||28.4|9.5|<0.001
71050726|NCT01986010|141608029|OTHER||GMT Ratio|76.6|||<|0.001|TWO_SIDED|95.0|49.5|118.6||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||118.6|49.5|<0.001
71050727|NCT01986010|141608029|OTHER||GMT Ratio|68.1|||<|0.001|TWO_SIDED|95.0|40.1|115.6||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||115.6|40.1|<0.001
71050728|NCT01986010|141608029|OTHER||GMT Ratio|41.0|||<|0.001|TWO_SIDED|95.0|23.8|70.7||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||70.7|23.8|<0.001
71050729|NCT01986010|141608029|OTHER||GMT Ratio|128.6|||<|0.001|TWO_SIDED|95.0|87.0|190.3||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||190.3|87.0|<0.001
71050730|NCT01986010|141608029|OTHER||GMT Ratio|62.0|||<|0.001|TWO_SIDED|95.0|30.5|126.1||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||126.1|30.5|<0.001
71050731|NCT01986010|141608029|OTHER||GMT Ratio|63.0|||<|0.001|TWO_SIDED|95.0|31.9|124.6||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||124.6|31.9|<0.001
71017097|NCT03692078|141541640|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.085|||<|0.0001|TWO_SIDED|95.0|0.788|1.382|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||1.382|0.788|<.0001
70931306|NCT01074294|141362860|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.6707|TWO_SIDED|95.0|-1.0|1.55||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||1.55|-1.00|0.6707
71017098|NCT03692078|141541640|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.104|||<|0.0001|TWO_SIDED|95.0|0.807|1.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||1.400|0.807|<.0001
71017099|NCT03692078|141541640|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.606|||<|0.0001|TWO_SIDED|95.0|0.326|0.886|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||0.886|0.326|<.0001
71017100|NCT03692078|141541640|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.476||||0.0011|TWO_SIDED|95.0|0.192|0.76|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||0.760|0.192|0.0011
71050732|NCT03276221|141608079|SUPERIORITY||Slope|-0.19|STANDARD_ERROR_OF_MEAN|0.15||0.215|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the paired associates learning module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making an error for the abstinence group above and beyond the monitoring group (positive values indicate higher error commission for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.215
71079496|NCT00482170|141666454|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.38|||<|0.001|TWO_SIDED|95.0|0.27|0.54||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.54|0.27|<0.001
71079497|NCT00482170|141666454|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.31|||<|0.001|TWO_SIDED|95.0|0.21|0.46||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.46|0.21|<0.001
71079498|NCT00482170|141666454|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.34|||<|0.001|TWO_SIDED|95.0|0.24|0.5||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.50|0.24|<0.001
71079499|NCT00482170|141666454|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.35|||<|0.001|TWO_SIDED|95.0|0.24|0.5||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||0.50|0.24|<0.001
70931307|NCT01074294|141362860|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.6638|TWO_SIDED|95.0|-1.04|1.64||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.64|-1.04|0.6638
70931308|NCT01074294|141362860|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.2252|TWO_SIDED|95.0|-0.56|2.36||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||2.36|-0.56|0.2252
70931309|NCT01074294|141362860|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.697|TWO_SIDED|95.0|-1.14|1.7||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||1.70|-1.14|0.6970
70941595|NCT02005029|141383908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.75|STANDARD_DEVIATION|5.0||0.0314|TWO_SIDED||||||t-test, 2 sided||"Mean difference in on score versus off score from the MDS UPDRS Part 3 on day of erythromycin minus the mean difference in 'on score versus off score on day of placebo."|||||0.0314
71017101|NCT03692078|141541640|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.505||||0.0006|TWO_SIDED|95.0|0.219|0.79|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||0.790|0.219|0.0006
71017102|NCT03692078|141541640|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.775|||<|0.0001|TWO_SIDED|95.0|0.49|1.06|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||1.060|0.490|<.0001
71017103|NCT03692078|141541640|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-2.116|||<|0.0001|TWO_SIDED|95.0|-2.472|-1.761|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||-1.761|-2.472|<.0001
71017104|NCT03692078|141541640|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-2.016|||<|0.0001|TWO_SIDED|95.0|-2.376|-1.656|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||-1.656|-2.376|<.0001
71050733|NCT03276221|141608080|SUPERIORITY||Slope|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.495|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the paired associates learning module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of picking the correct box for the abstinence group above and beyond the monitoring group (positive values indicate better memory performance for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.495
71105232|NCT00127439|141717713|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon rank sum test|||Pearson correlation of gait speed changes with directional difference of standardized kinematic scores (i.e. foot trajectory toe-off - degrees, foot trajectory toe-off - % cycle, foot trajectory initial contact - degrees, foot trajectory range - degrees, propulsive impulse N-s, minimum thigh angle - flexion degrees, minimum hip angle - extension degrees, trunk angle mid-stance)||||0.05
71105233|NCT00127439|141717714|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.05|||||||t-test, 2 sided|||||||0.05
71105234|NCT00127439|141717715|NON_INFERIORITY_OR_EQUIVALENCE|Provided previously||||||0.05|||||||t-test, 2 sided|||||||0.05
71105235|NCT00127439|141717716|NON_INFERIORITY_OR_EQUIVALENCE|Provided previously||||||0.05|||||||t-test, 2 sided|||||||0.05
71105236|NCT00127439|141717717|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.05|||||||t-test, 2 sided|||||||0.05
71105237|NCT00127439|141717718|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.05|||||||t-test, 2 sided|||||||0.05
71105238|NCT00127439|141717719|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.05|||||||t-test, 2 sided|||||||0.05
71105239|NCT00127439|141717720|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.05|||||||t-test, 2 sided|||||||0.05
71105240|NCT00127439|141717721|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.05|||||||t-test, 2 sided|||||||0.05
70931310|NCT01074294|141362861|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.6008|TWO_SIDED|95.0|-0.64|1.11||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||1.11|-0.64|0.6008
71105241|NCT04067011|141717742|EQUIVALENCE|The equivalence testing was constructed using paired two one-sided t-tests (TOST) with natural log transformation of PK parameters. Results obtained from transformed analyses were back-transformed by exponentiation for presentation of the point estimates and 90% CIs for geometric mean ratio of AUC0-12h.|Ratio of AUC|0.9764|||||TWO_SIDED|90.0|0.8895|1.0718||||||Analysis of Geometric mean ratio of area under the curve from 0 to 12 hours (AUC0-12h) for ciprofloxacin on Days 8 and 35||1.0718|0.8895|
71105242|NCT04067011|141717742|EQUIVALENCE|The equivalence testing was constructed using paired two one-sided t-tests (TOST) with natural log transformation of PK parameters. Results obtained from transformed analyses were back-transformed by exponentiation for presentation of the point estimates and 90% CIs for geometric mean ratio of Cmax.|Ratio of Cmax|0.9706|||||TWO_SIDED|90.0|0.8693|1.0838||||||Analysis of Geometric mean ration of Cmax for ciprofloxacin on Days 8 and 35||1.0838|0.8693|
70851001|NCT01640834|141190269|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.0||||0.046|TWO_SIDED|95.0|-33.7|-0.4|||t-test, 1 sided|||Analysis was performed using the percent change in insulin dose, which takes into account absolute differences in individual insulin doses. The mean percent change on Day 2 from Day 1 in the 24-hour insulin dose for the placebo group was subtracted from each participant's percent change on Day 2 from Day 1 in the 24-hour insulin dose. This placebo adjusted 24-hour insulin dose was compared within the 100-mg LY2409021 dose group using a 1 sample t-test.||-0.4|-33.7|0.0460
70931311|NCT01074294|141362861|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.5859|TWO_SIDED|95.0|-0.72|1.27||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.27|-0.72|0.5859
70931312|NCT01074294|141362861|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.7406|TWO_SIDED|95.0|-0.96|1.34||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||1.34|-0.96|0.7406
70931313|NCT01074294|141362861|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.8568|TWO_SIDED|95.0|-1.14|1.37||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.37|-1.14|0.8568
70931314|NCT01074294|141362861|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.6044|TWO_SIDED|95.0|-0.96|1.64||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||1.64|-0.96|0.6044
70931315|NCT01074294|141362861|SUPERIORITY||Mean Difference (Final Values)|0.29||||0.6772|TWO_SIDED|95.0|-1.08|1.66||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||1.66|-1.08|0.6772
70931316|NCT01074294|141362862|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.7881|TWO_SIDED|95.0|-0.87|1.15||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||1.15|-0.87|0.7881
70931317|NCT01074294|141362862|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.8841|TWO_SIDED|95.0|-1.38|1.19||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.19|-1.38|0.8841
70931318|NCT01074294|141362862|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.7589|TWO_SIDED|95.0|-1.61|1.17||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||1.17|-1.61|0.7589
70931319|NCT01074294|141362862|SUPERIORITY||Mean Difference (Final Values)|0.46||||0.5375|TWO_SIDED|95.0|-1.01|1.93||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.93|-1.01|0.5375
71105243|NCT04067011|141717743|EQUIVALENCE|The equivalence testing was constructed using paired two one-sided t-tests (TOST) with natural log transformation of PK parameters. Results obtained from transformed analyses were back-transformed by exponentiation for presentation of the point estimates and 90% CIs for geometric mean ratio of AUC0-12h.|Ratio of AUC|0.9173|||||TWO_SIDED|90.0|0.8187|1.0278||||||Analysis of Geometric mean ratio of Area under the curve from 0 to 12 hours (AUC0-12h) for doxycycline on Days 8 and 38||1.0278|0.8187|
70941596|NCT02005029|141383909|SUPERIORITY_OR_OTHER||Erythromycin:Placebo Cmax ratio|0.83|STANDARD_DEVIATION|0.24|||TWO_SIDED|||||||||||||
70931320|NCT01074294|141362862|SUPERIORITY||Mean Difference (Final Values)|0.58||||0.4456|TWO_SIDED|95.0|-0.92|2.08||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||2.08|-0.92|0.4456
70931321|NCT01074294|141362862|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.667|TWO_SIDED|95.0|-1.21|1.89||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||1.89|-1.21|0.6670
70931322|NCT01074294|141362863|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.9708|TWO_SIDED|95.0|-0.97|1.01||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.01|-0.97|0.9708
70931323|NCT01074294|141362863|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.397|TWO_SIDED|95.0|-0.65|1.63||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.63|-0.65|0.3970
70931324|NCT01074294|141362864|SUPERIORITY||Risk Ratio (RR)|1.01||||0.9568|TWO_SIDED|95.0|0.68|1.5||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Difficulty Falling Asleep: Week 7||1.50|0.68|0.9568
70931325|NCT01074294|141362864|SUPERIORITY||Risk Ratio (RR)|0.91||||0.6308|TWO_SIDED|95.0|0.63|1.31||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Difficulty Falling Asleep: Week 9||1.31|0.63|0.6308
70931326|NCT01074294|141362864|SUPERIORITY||Risk Ratio (RR)|0.92||||0.6698|TWO_SIDED|95.0|0.64|1.32||The p-value was derived from CMH general association test controlling for study center|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Difficulty Falling Asleep: Week 11||1.32|0.64|0.6698
70931327|NCT01074294|141362864|SUPERIORITY||Risk Ratio (RR)|0.76||||0.2012|TWO_SIDED|95.0|0.5|1.15||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Difficulty Staying Asleep: Week 7||1.15|0.50|0.2012
70931328|NCT01074294|141362864|SUPERIORITY||Risk Ratio (RR)|0.78||||0.2365|TWO_SIDED|95.0|0.52|1.16||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Difficulty Staying Asleep: Week 9||1.16|0.52|0.2365
70931329|NCT01074294|141362864|SUPERIORITY||Risk Ratio (RR)|0.65||||0.0312|TWO_SIDED|95.0|0.44|0.96||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Difficulty Staying Asleep: Week 11||0.96|0.44|0.0312
70931330|NCT01074294|141362864|SUPERIORITY||Risk Ratio (RR)|1.12||||0.6408|TWO_SIDED|95.0|0.69|1.81||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Waking Up Too Early: Week 7||1.81|0.69|0.6408
70931331|NCT01074294|141362864|SUPERIORITY||Risk Ratio (RR)|1.24||||0.3467|TWO_SIDED|95.0|0.79|1.96||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Waking Up Too Early: Week 9||1.96|0.79|0.3467
70931332|NCT01074294|141362864|SUPERIORITY||Risk Ratio (RR)|1.02||||0.9437|TWO_SIDED|95.0|0.65|1.59||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Waking Up Too Early: Week 11||1.59|0.65|0.9437
70931333|NCT01074294|141362865|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.6357|TWO_SIDED|95.0|-1.3|2.12||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||2.12|-1.30|0.6357
70931334|NCT01074294|141362865|SUPERIORITY||Mean Difference (Final Values)|0.46||||0.6536|TWO_SIDED|95.0|-1.56|2.48||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||2.48|-1.56|0.6536
70941597|NCT04748445|141383932|OTHER||Slope|0.065|||<|0.0001|TWO_SIDED|90.0|0.046|0.083|||Mixed Models Analysis|||Chills||0.083|0.046|<.0001
70931335|NCT01074294|141362865|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.9475|TWO_SIDED|95.0|-2.2|2.06||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||2.06|-2.20|0.9475
70931336|NCT01074294|141362865|SUPERIORITY||Mean Difference (Final Values)|0.99||||0.3973|TWO_SIDED|95.0|-1.31|3.29||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||3.29|-1.31|0.3973
71017105|NCT03692078|141541640|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.605|||<|0.0001|TWO_SIDED|95.0|-1.958|-1.253|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||-1.253|-1.958|<.0001
71017106|NCT03692078|141541640|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.642|||<|0.0001|TWO_SIDED|95.0|-2.003|-1.282|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||-1.282|-2.003|<.0001
71017107|NCT03692078|141541640|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.578|||<|0.0001|TWO_SIDED|95.0|-1.922|-1.234|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||-1.234|-1.922|<.0001
71017108|NCT03692078|141541640|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.726|||<|0.0001|TWO_SIDED|95.0|-2.074|-1.378|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||-1.378|-2.074|<.0001
71017109|NCT03692078|141541640|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.479||||0.1579|TWO_SIDED|95.0|-1.054|0.097|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||0.097|-1.054|0.1579
71017110|NCT03692078|141541640|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.628||||0.026|TWO_SIDED|95.0|-1.207|-0.048|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.048|-1.207|0.0260
71050734|NCT03276221|141608081|SUPERIORITY||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.14||0.05|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the spatial span module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of reaching a longer span for the abstinence group above and beyond the monitoring group (positive values indicate higher span lengths for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.050
71077892|NCT02913105|141664398|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.447|TWO_SIDED|90.0|0.83|1.07|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 42||1.07|0.83|0.4470
70941598|NCT04748445|141383932|OTHER||Slope|0.281|||<|0.0001|TWO_SIDED|90.0|0.221|0.341|||Mixed Models Analysis|||Cough||0.341|0.221|<.0001
70941599|NCT04748445|141383932|OTHER||Slope|0.036|||<|0.0001|TWO_SIDED|90.0|0.023|0.048|||Mixed Models Analysis|||Diarrhea||0.048|0.023|<.0001
71017111|NCT03692078|141541640|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.58||||0.0483|TWO_SIDED|95.0|-1.158|-0.003|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.003|-1.158|0.0483
71017112|NCT03692078|141541640|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.329||||0.5842|TWO_SIDED|95.0|-0.906|0.249|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.249|-0.906|0.5842
71017113|NCT03692078|141541640|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-3.201|||<|0.0001|TWO_SIDED|95.0|-3.856|-2.546|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.546|-3.856|<.0001
71017114|NCT03692078|141541640|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-3.119|||<|0.0001|TWO_SIDED|95.0|-3.779|-2.46|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.460|-3.779|<.0001
71017115|NCT03692078|141541640|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.69|||<|0.0001|TWO_SIDED|95.0|-3.338|-2.043|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.043|-3.338|<.0001
71077893|NCT02913105|141664398|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.4342|TWO_SIDED|90.0|0.83|1.07|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 56||1.07|0.83|0.4342
70931337|NCT01074294|141362865|SUPERIORITY||Mean Difference (Final Values)|1.47||||0.2336|TWO_SIDED|95.0|-0.96|3.91||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||3.91|-0.96|0.2336
70931338|NCT01074294|141362865|SUPERIORITY||Mean Difference (Final Values)|0.95||||0.4553|TWO_SIDED|95.0|-1.55|3.44||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||3.44|-1.55|0.4553
70931339|NCT01074294|141362866|SUPERIORITY||Mean Difference (Final Values)|0.29||||0.5647|TWO_SIDED|95.0|-0.7|1.27||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||1.27|-0.70|0.5647
71079500|NCT00482170|141666455|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.33|||<|0.001|TWO_SIDED|95.0|0.24|0.46||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.46|0.24|<0.001
70851002|NCT01640834|141190269|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.6||||0.0192|TWO_SIDED|95.0|-35.0|-4.3|||t-test, 1 sided|||Analysis was performed using the percent change in insulin dose, which takes into account absolute differences in individual insulin doses. The mean percent change on Day 2 from Day 1 in the 24-hour insulin dose for the placebo group was subtracted from each participant's percent change on Day 2 from Day 1 in the 24-hour insulin dose. This placebo adjusted 24-hour insulin dose was compared within the 300-mg LY2409021 dose group using a 1 sample t-test.||-4.3|-35.0|0.0192
70851003|NCT01640834|141190274|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-46.0||||0.0187|TWO_SIDED|95.0|-82.0|-9.0|||t-test, 2 sided|||Statistical analysis of the effect of LY2409021 treatment on peak glucose concentration after an intramuscular injection of glucagon (1 milligram).||-9|-82|0.0187
70851004|NCT01640834|141190274|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-59.0||||0.0048|TWO_SIDED|95.0|-96.0|-23.0|||t-test, 2 sided|||Statistical analysis of the effect of LY2409021 treatment on peak glucose concentration after an intramuscular injection of glucagon (1 milligram).||-23|-96|0.0048
70851005|NCT01640834|141190275|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4423.0||||0.0278|TWO_SIDED|95.0|-8256.0|-590.0|||t-test, 2 sided|||Statistical analysis of the effect of LY2409021 treatment on area under the glucose concentration curve from time 0 to 2 hours postdose following an intramuscular injection of glucagon (1 milligram).||-590|-8256|0.0278
70851006|NCT01640834|141190275|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5187.0||||0.0046|TWO_SIDED|95.0|-8371.0|-2004.0|||t-test, 2 sided|||Statistical analysis of the effect of LY2409021 treatment on area under the glucose concentration curve from time 0 to 2 hours postdose following an intramuscular injection of glucagon (1 milligram).||-2004|-8371|0.0046
70851007|NCT02055118|141190304|SUPERIORITY||Least squares mean|3.0|STANDARD_ERROR_OF_MEAN|5.12||0.5669|TWO_SIDED|95.0|-7.3|13.3|||Mixed model repeated measures|||The Mixed model repeated measures included fixed categorical effects for treatment, visit week, treatment by visit week interaction, baseline GCA classification factor (less than or equal to \[\<=\] 70 or \>70), baseline age group (\<6 years or \>=6 years), treatment by baseline GCA classification factor interaction, treatment by baseline age group interaction, interaction between baseline GCA classification factor and baseline age group, genotype, and the baseline GCA score as a continuous covariate.||13.3|-7.3|0.5669
70851008|NCT01215097|141190338|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.7|-0.34|||ANCOVA|||||-0.34|-0.70|<0.0001
70851009|NCT01215097|141190339|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.433|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001|TWO_SIDED|95.0|-0.555|-0.311|||ANCOVA|||||-0.311|-0.555|<0.0001
70851010|NCT01215097|141190340|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.591|STANDARD_ERROR_OF_MEAN|0.082|<|0.0001||95.0|-0.752|-0.43|||ANCOVA|||||-0.43|-0.752|<0.0001
70851011|NCT01215097|141190341|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.7|-0.35|||ANCOVA|||||-0.35|-0.70|<0.0001
70851012|NCT01215097|141190342|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.71|-0.32|||ANCOVA|||||-0.32|-0.71|<0.0001
70851013|NCT01215097|141190343|SUPERIORITY_OR_OTHER||Adjusted mean difference|-9.6|STANDARD_ERROR_OF_MEAN|4.2||0.0233||95.0|-17.8|-1.3|||ANCOVA|||||-1.3|-17.8|0.0233
70851014|NCT01215097|141190344|SUPERIORITY_OR_OTHER||Adjusted mean difference|-22.1|STANDARD_ERROR_OF_MEAN|3.3|<|0.0001||95.0|-28.7|-15.6|||ANCOVA|||||-15.6|-28.7|<0.0001
70851015|NCT01215097|141190345|SUPERIORITY_OR_OTHER||Adjusted mean difference|-10.2|STANDARD_ERROR_OF_MEAN|3.6||0.005||95.0|-17.3|-3.1|||ANCOVA|||||-3.1|-17.3|0.0050
70851016|NCT01215097|141190346|SUPERIORITY_OR_OTHER||Adjusted mean difference|-11.5|STANDARD_ERROR_OF_MEAN|4.0||0.0044||95.0|-19.5|-3.6|||ANCOVA|||||-3.6|-19.5|0.0044
70851017|NCT01215097|141190348|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.243|||<|0.0001||95.0|2.831|13.769|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication||Comparison by odds ratio for the patients with a baseline HbA1c \>=7.0%||13.769|2.831|<0.0001
70851018|NCT01215097|141190350|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.97||||0.0129||95.0|1.404|17.592|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication||Comparison by odds ratio for the patients with a baseline HbA1c \>= 6.5%||17.592|1.404|0.0129
70931340|NCT01074294|141362866|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.9739|TWO_SIDED|95.0|-1.15|1.12||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.12|-1.15|0.9739
71017116|NCT03692078|141541640|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-2.746|||<|0.0001|TWO_SIDED|95.0|-3.402|-2.09|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.090|-3.402|<.0001
71017117|NCT03692078|141541640|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.184|||<|0.0001|TWO_SIDED|95.0|1.565|2.803|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||2.803|1.565|<.0001
71017118|NCT03692078|141541640|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.202|||<|0.0001|TWO_SIDED|95.0|1.576|2.828|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||2.828|1.576|<.0001
71017119|NCT03692078|141541640|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.083|||<|0.0001|TWO_SIDED|95.0|1.461|2.704|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||2.704|1.461|<.0001
71017120|NCT03692078|141541640|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.501|||<|0.0001|TWO_SIDED|95.0|1.876|3.126|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||3.126|1.876|<.0001
71017121|NCT03692078|141541640|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.538||||0.2085|TWO_SIDED|95.0|-1.231|0.154|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.154|-1.231|0.2085
71017122|NCT03692078|141541640|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.289||||0.8557|TWO_SIDED|95.0|-0.988|0.41|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.410|-0.988|0.8557
71077894|NCT02913105|141664398|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.85||||0.0891|TWO_SIDED|90.0|0.73|0.99|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 84||0.99|0.73|0.0891
70931341|NCT01074294|141362866|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.8077|TWO_SIDED|95.0|-1.4|1.09||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||1.09|-1.40|0.8077
70931342|NCT01074294|141362866|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.6119|TWO_SIDED|95.0|-0.98|1.65||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.65|-0.98|0.6119
71105244|NCT04067011|141717743|EQUIVALENCE|The equivalence testing was constructed using paired two one-sided t-tests (TOST) with natural log transformation of PK parameters. Results obtained from transformed analyses were back-transformed by exponentiation for presentation of the point estimates and 90% CIs for geometric mean ratio of Cmax.|Ratio of Cmax|0.8974|||||TWO_SIDED|90.0|0.7841|1.0271||||||Analysis of Geometric mean ration of Cmax for doxycycline on Days 8 and 38||1.0271|0.7841|
71017123|NCT03692078|141541640|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.027||||1|TWO_SIDED|95.0|-0.713|0.658|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.658|-0.713|1.0000
71017124|NCT03692078|141541640|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.084||||1|TWO_SIDED|95.0|-0.612|0.78|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.780|-0.612|1.0000
71017125|NCT03692078|141541642|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.081|||<|0.0001|TWO_SIDED|95.0|0.679|1.484|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||1.484|0.679|<.0001
71017126|NCT03692078|141541642|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.309|||<|0.0001|TWO_SIDED|95.0|0.902|1.716|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||1.716|0.902|<.0001
71017127|NCT03692078|141541642|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.996|||<|0.0001|TWO_SIDED|95.0|0.615|1.377|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||1.377|0.615|<.0001
71017128|NCT03692078|141541642|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.728||||0.0003|TWO_SIDED|95.0|0.339|1.116|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||1.116|0.339|0.0003
71105245|NCT04067011|141717744|NON_INFERIORITY|Non-inferiority margin is 0.5.|Ratio of GMT (Group 1/Group 3)|1.13|||||TWO_SIDED|95.0|0.78|1.64||||||||1.64|0.78|
70931343|NCT01074294|141362866|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.5513|TWO_SIDED|95.0|-0.94|1.76||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||1.76|-0.94|0.5513
70931344|NCT01074294|141362866|SUPERIORITY||Mean Difference (Final Values)|0.57||||0.4185|TWO_SIDED|95.0|-0.81|1.95||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||1.95|-0.81|0.4185
70931345|NCT01074294|141362867|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.7556|TWO_SIDED|95.0|-0.8|1.09||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||1.09|-0.80|0.7556
70931346|NCT01074294|141362867|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.371|TWO_SIDED|95.0|-0.6|1.59||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.59|-0.60|0.3710
71017129|NCT03692078|141541642|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.987|||<|0.0001|TWO_SIDED|95.0|0.593|1.381|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||1.381|0.593|<.0001
71017130|NCT03692078|141541642|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.865|||<|0.0001|TWO_SIDED|95.0|0.475|1.254|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||1.254|0.475|<.0001
71017131|NCT03692078|141541642|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.436||||0.0768|TWO_SIDED|95.0|-0.047|0.92|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||0.920|-0.047|0.0768
71017132|NCT03692078|141541642|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.091||||0.7155|TWO_SIDED|95.0|-0.4|0.583|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||0.583|-0.400|0.7155
71017133|NCT03692078|141541642|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.237||||0.3282|TWO_SIDED|95.0|-0.239|0.713|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||0.713|-0.239|0.3282
71017134|NCT03692078|141541642|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-0.23||||0.3578|TWO_SIDED|95.0|-0.722|0.262|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||0.262|-0.722|0.3578
71050735|NCT03276221|141608082|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.12||0.532|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the spatial span module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of reaching a longer span for the abstinence group above and beyond the monitoring group (positive values indicate higher span lengths for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.532
71050736|NCT03276221|141608083|SUPERIORITY||Slope|0.09|STANDARD_ERROR_OF_MEAN|0.07||0.226|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the verbal recognition memory module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making a correct choice for the abstinence group above and beyond the monitoring group (positive values indicate higher memory performance for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.226
71077895|NCT02913105|141664398|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.89||||0.226|TWO_SIDED|90.0|0.77|1.04|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 112 (EOS)||1.04|0.77|0.2260
71105246|NCT04067011|141717744|NON_INFERIORITY|Non-inferiority margin is 0.5.|Ratio of GMT (Group 2/Group 3)|1.14|||||TWO_SIDED|95.0|0.81|1.6||||||||1.6|0.81|
70931347|NCT01074294|141362867|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.8464|TWO_SIDED|95.0|-0.99|1.21||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||1.21|-0.99|0.8464
70931348|NCT01074294|141362867|SUPERIORITY||Mean Difference (Final Values)|0.69||||0.2664|TWO_SIDED|95.0|-0.53|1.91||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.91|-0.53|0.2664
71017135|NCT03692078|141541642|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.338||||0.1638|TWO_SIDED|95.0|-0.138|0.814|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||0.814|-0.138|0.1638
71017136|NCT03692078|141541642|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-0.05||||0.8384|TWO_SIDED|95.0|-0.533|0.433|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||0.433|-0.533|0.8384
70931349|NCT01074294|141362867|SUPERIORITY||Mean Difference (Final Values)|1.13||||0.0876|TWO_SIDED|95.0|-0.17|2.42||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||2.42|-0.17|0.0876
71017137|NCT03692078|141541642|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.086||||1|TWO_SIDED|95.0|-0.869|0.698|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||0.698|-0.869|1.0000
71017138|NCT03692078|141541642|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.581||||0.2808|TWO_SIDED|95.0|-1.377|0.214|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||0.214|-1.377|0.2808
71105247|NCT05209386|141717767|OTHER||||||||||||||||||Permutation-based clustering analysis was used to identify channels that significantly encode change in acoustic dimensions. For each channel, a sliding-window encoding model was built comparing evoked responses (z-scored voltages) to Canonical Block stimuli across varying F0 with fixed VOT. This analysis identified the n = 17 channels and time windows where neural responses differed according to change in F0.|||
71105248|NCT05209386|141717768|OTHER||||||<|0.0001|||||||t-test, 2 sided|t(20.45) = -5.8||||||<0.0001
70931350|NCT01074294|141362867|SUPERIORITY||Mean Difference (Final Values)|0.44||||0.5119|TWO_SIDED|95.0|-0.89|1.77||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||1.77|-0.89|0.5119
70931351|NCT01074294|141362868|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.8986|TWO_SIDED|95.0|-1.03|1.18||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||1.18|-1.03|0.8986
70851019|NCT01215097|141190351|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.054|||<|0.0001||95.0|1.799|5.185|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication||Comparison by odds ratio for the patients with HbA1c at least lowering 0.5% from baseline||5.185|1.799|<0.0001
70931352|NCT01074294|141362868|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.685|TWO_SIDED|95.0|-1.02|1.55||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.55|-1.02|0.6850
70851020|NCT00329524|141190374|NON_INFERIORITY_OR_EQUIVALENCE|Power analysis based on paired t-test.|||||<|0.05||95.0|||||t-test, 2 sided|||||||<.05
70931353|NCT01074294|141362868|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.7108|TWO_SIDED|95.0|-1.61|1.1||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||1.10|-1.61|0.7108
70931354|NCT01074294|141362868|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.9236|TWO_SIDED|95.0|-1.5|1.36||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.36|-1.50|0.9236
70931355|NCT01074294|141362868|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.8576|TWO_SIDED|95.0|-1.35|1.61||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||1.61|-1.35|0.8576
70931356|NCT01074294|141362868|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.8483|TWO_SIDED|95.0|-1.67|1.37||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||1.37|-1.67|0.8483
70931357|NCT01074294|141362869|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.6976|TWO_SIDED|95.0|-0.22|0.15||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||0.15|-0.22|0.6976
70931358|NCT01074294|141362869|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.6986|TWO_SIDED|95.0|-0.25|0.17||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||0.17|-0.25|0.6986
70931359|NCT01074294|141362869|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.6507|TWO_SIDED|95.0|-0.3|0.19||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||0.19|-0.30|0.6507
70931360|NCT01074294|141362869|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.655|TWO_SIDED|95.0|-0.32|0.2||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||0.20|-0.32|0.6550
70931361|NCT01074294|141362869|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.3959|TWO_SIDED|95.0|-0.15|0.38||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||0.38|-0.15|0.3959
70931362|NCT01074294|141362869|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.6763|TWO_SIDED|95.0|-0.23|0.35||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||0.35|-0.23|0.6763
70851021|NCT00329524|141190375|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||test for order effect|||||||.05
70851022|NCT01001325|141190377|SUPERIORITY_OR_OTHER|||||||0.685||95.0|||||Fisher Exact|||"Null hypothesis: There is no difference in incidence of pandemic strain influenza infection for people given seasonal influenza vaccine compared to those given a placebo.~Power to detect a 2-fold difference if attack rate in non-vaccinated participants is 10%: 86%"||||0.685
70851023|NCT01584440|141190378|SUPERIORITY||Ordinary Least Squares (OLS) Z-statistic|-1.5|||<=|0.001|TWO_SIDED||||||ANCOVA|Sequential Parallel Comparison Design (SPCD): data from the Stages 1 and 2 are analyzed together using the mITT Population||||||<=0.001
70931363|NCT01074294|141362870|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.4089|TWO_SIDED|95.0|-0.37|0.91||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.91|-0.37|0.4089
70931364|NCT01074294|141362871|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.2331|TWO_SIDED|95.0|-0.8|0.2||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||Week 11 data is included here. The planned sample size of 225 participants (150 in brexipiprazole arm and 75 in the placebo arm) yielded at least 80% power to detect effects at a 2-tailed significance level of 0.05 using a two-sided z-test.|||0.20|-0.80|0.2331
70941600|NCT04748445|141383932|OTHER||Slope|0.113|||<|0.0001|TWO_SIDED|90.0|0.069|0.156|||Mixed Models Analysis|||Difficulty breathing||0.156|0.069|<.0001
70851024|NCT01584440|141190378|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.5|||||TWO_SIDED||||||||Day 36|||||
70851025|NCT01584440|141190378|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.59|||||TWO_SIDED||||||||Day 70|||||
70931365|NCT01074294|141362872|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.067|TWO_SIDED|95.0|-0.01|0.0||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.00|-0.01|0.0670
70931366|NCT01074294|141362873|SUPERIORITY||Mean Difference (Final Values)|-14.3||||0.0849|TWO_SIDED|95.0|-30.5|1.98||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||1.98|-30.5|0.0849
70931367|NCT01074294|141362874|SUPERIORITY||Mean Difference (Final Values)|-0.46||||0.7663|TWO_SIDED|95.0|-3.52|2.6||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||2.60|-3.52|0.7663
70931368|NCT01074294|141362875|SUPERIORITY||Mean Difference (Final Values)|17.51||||0.0298|TWO_SIDED|95.0|1.73|33.29||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||33.29|1.73|0.0298
70931369|NCT01074294|141362876|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.2563|TWO_SIDED|95.0|-0.05|0.01||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.01|-0.05|0.2563
70931370|NCT01074294|141362877|SUPERIORITY||Mean Difference (Final Values)|-5.67||||0.6644|TWO_SIDED|95.0|-31.4|20.06||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||20.06|-31.4|0.6644
70931371|NCT01074294|141362878|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.8418|TWO_SIDED|95.0|-0.56|0.45||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.45|-0.56|0.8418
70931372|NCT01074294|141362879|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.2513|TWO_SIDED|95.0|-0.69|0.18||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.18|-0.69|0.2513
70931373|NCT01074294|141362880|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.7037|TWO_SIDED|95.0|-0.48|0.71||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.71|-0.48|0.7037
70931374|NCT01074294|141362881|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.7572|TWO_SIDED|95.0|-0.17|0.23||The p-value was derived from CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 6||0.23|-0.17|0.7572
71105249|NCT05209386|141717769|OTHER||||||<|0.0001|||||||Mixed Models Analysis|For interaction term (effect of interest): t(1016) = -2.7|||Time-averaged neural responses across respective windows of significance were averaged for all stimuli with ambiguous VOT (Canonical and Reverse blocks) to provide trial-averaged responses. A single linear mixed-effects model was built with fixed effects of F0, condition/listening context (block), and their interaction, as well as a random effect (intercept only) of patient+channel. The effect of interest was the interaction term, indicating that neural responses to F0 varied according to listening context (block).|||<0.0001
70851026|NCT01584440|141190380|SUPERIORITY||OLS Z-statistic|-2.46||||0.014|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.014
70931375|NCT01074294|141362881|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.6132|TWO_SIDED|95.0|-0.28|0.17||The p-value was derived from CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 7||0.17|-0.28|0.6132
70931376|NCT01074294|141362881|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.9312|TWO_SIDED|95.0|-0.25|0.27||The p-value was derived from CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 8||0.27|-0.25|0.9312
70931377|NCT01074294|141362881|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.8073|TWO_SIDED|95.0|-0.3|0.24||The p-value was derived from CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 9||0.24|-0.30|0.8073
70931378|NCT01074294|141362881|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.9168|TWO_SIDED|95.0|-0.26|0.29||The p-value was derived from CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 10||0.29|-0.26|0.9168
70941601|NCT04748445|141383932|OTHER||Slope|0.259|||<|0.0001|TWO_SIDED|90.0|0.206|0.312|||Mixed Models Analysis|||Fatigue||0.312|0.206|<.0001
70941602|NCT04748445|141383932|OTHER||Slope|0.029|||<|0.0001|TWO_SIDED|90.0|0.02|0.037|||Mixed Models Analysis|||Fever||0.037|0.020|<.0001
70851027|NCT01584440|141190380|SUPERIORITY||ANCOVA Least Squares Mean Difference|-4.2|||||TWO_SIDED||||||||||Day 36|||
70931379|NCT01074294|141362881|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.7432|TWO_SIDED|95.0|-0.34|0.25||The p-value was derived from CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 11||0.25|-0.34|0.7432
70931380|NCT01074294|141362882|SUPERIORITY||Risk Ratio (RR)|1.2||||0.6014|TWO_SIDED|95.0|0.6|2.42||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 6||2.42|0.60|0.6014
70931381|NCT01074294|141362882|SUPERIORITY||Risk Ratio (RR)|1.02||||0.9225|TWO_SIDED|95.0|0.64|1.63||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 7||1.63|0.64|0.9225
70931382|NCT01074294|141362882|SUPERIORITY||Risk Ratio (RR)|0.86||||0.4803|TWO_SIDED|95.0|0.58|1.3||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 8||1.30|0.58|0.4803
70931383|NCT01074294|141362882|SUPERIORITY||Risk Ratio (RR)|0.91||||0.5876|TWO_SIDED|95.0|0.65|1.27||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 9||1.27|0.65|0.5876
71105250|NCT05209386|141717770|OTHER||||||<|0.0001|||||||Mixed Models Analysis|t(48) = -4.50||The null hypothesis is that there is no effect of change in listening context on behavioral responses of participants.||||<0.0001
71105251|NCT05209386|141717771|OTHER||||||||||||||||||Permutation-based clustering analysis was used to identify channels in non-regions of interest that significantly encode change in acoustic dimensions. For each channel, a sliding-window encoding model was built comparing evoked responses (z-scored voltages) to Canonical Block stimuli across varying F0 with fixed VOT. This analysis identified the n = 4 channels and time windows where neural responses differed according to change in F0.|||
71105252|NCT05209386|141717772|OTHER|||||||0.48|||||||Mixed Models Analysis|For interaction term (effect of interest): t(216) = -0.707|||Time-averaged neural responses across respective windows of significance were averaged for all stimuli with ambiguous VOT (Canonical and Reverse blocks) to provide trial-averaged responses. A single linear mixed-effects model was built with fixed effects of F0, condition/listening context (block), and their interaction, as well as a random effect (intercept only) of patient+channel. The effect of interest was the interaction term, indicating that neural responses to F0 varied according to listening context (block).|||0.480
71105253|NCT04251533|141717789|SUPERIORITY||Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|0.92|2.41|||Regression, Cox|||||2.41|0.92|
71105254|NCT01561469|141717841|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||Regression, Logistic|||||||0.009
70851028|NCT01584440|141190380|SUPERIORITY||ANCOVA Least Squares Mean Difference|-3.78|||||TWO_SIDED||||||||Day 70|||||
70851029|NCT01584440|141190381|SUPERIORITY||OLS Z-statistic|0.77||||0.444|TWO_SIDED||||||ANCOVA|Delusions Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.444
70851030|NCT01584440|141190381|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.27|||||TWO_SIDED||||||||Delusions Domain; Day 36|||||
70851031|NCT01584440|141190381|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.78|||||TWO_SIDED||||||||Delusions Domain; Day 70|||||
70851032|NCT01584440|141190381|SUPERIORITY||OLS Z-statistic|-0.18||||0.861|TWO_SIDED||||||ANCOVA|Hallucinations Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.861
70851033|NCT01584440|141190381|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.29|||||TWO_SIDED||||||||Hallucinations Domain; Day 36|||||
70931384|NCT01074294|141362882|SUPERIORITY||Risk Ratio (RR)|0.87||||0.3727|TWO_SIDED|95.0|0.64|1.18||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 10||1.18|0.64|0.3727
70931385|NCT01074294|141362882|SUPERIORITY||Risk Ratio (RR)|0.93||||0.6265|TWO_SIDED|95.0|0.71|1.23||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 11||1.23|0.71|0.6265
70931386|NCT01074294|141362883|SUPERIORITY||Risk Ratio (RR)|1.1||||0.8586|TWO_SIDED|95.0|0.4|3.03||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 6||3.03|0.40|0.8586
70931387|NCT01074294|141362883|SUPERIORITY||Risk Ratio (RR)|0.95||||0.8984|TWO_SIDED|95.0|0.46|1.99||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 7||1.99|0.46|0.8984
70931388|NCT01074294|141362883|SUPERIORITY||Risk Ratio (RR)|0.99||||0.9778|TWO_SIDED|95.0|0.57|1.74||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 8||1.74|0.57|0.9778
70931389|NCT01074294|141362883|SUPERIORITY||Risk Ratio (RR)|0.92||||0.7315|TWO_SIDED|95.0|0.56|1.5||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 9||1.50|0.56|0.7315
70931390|NCT01074294|141362883|SUPERIORITY||Risk Ratio (RR)|0.9||||0.6518|TWO_SIDED|95.0|0.57|1.42||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 10||1.42|0.57|0.6518
70931391|NCT01074294|141362883|SUPERIORITY||Risk Ratio (RR)|0.82||||0.3472|TWO_SIDED|95.0|0.55|1.23||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 11||1.23|0.55|0.3472
70931392|NCT01074294|141362884|SUPERIORITY||Risk Ratio (RR)|0.98||||0.9577|TWO_SIDED|95.0|0.44|2.16||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 6||2.16|0.44|0.9577
70931393|NCT01074294|141362884|SUPERIORITY||Risk Ratio (RR)|1.19||||0.5864|TWO_SIDED|95.0|0.63|2.27||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 7||2.27|0.63|0.5864
70931394|NCT01074294|141362884|SUPERIORITY||Risk Ratio (RR)|0.96||||0.8723|TWO_SIDED|95.0|0.57|1.6||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 8||1.60|0.57|0.8723
70931395|NCT01074294|141362884|SUPERIORITY||Risk Ratio (RR)|1.0||||0.9872|TWO_SIDED|95.0|0.65|1.52||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 9||1.52|0.65|0.9872
70931396|NCT01074294|141362884|SUPERIORITY||Risk Ratio (RR)|0.8||||0.3171|TWO_SIDED|95.0|0.52|1.23||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 10||1.23|0.52|0.3171
70931397|NCT01074294|141362884|SUPERIORITY||Risk Ratio (RR)|0.87||||0.4782|TWO_SIDED|95.0|0.6|1.27||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 11||1.27|0.60|0.4782
70931398|NCT01074294|141362885|SUPERIORITY||Risk Ratio (RR)|1.19||||0.7232|TWO_SIDED|95.0|0.45|3.19||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 6||3.19|0.45|0.7232
71017139|NCT03692078|141541642|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.095||||1|TWO_SIDED|95.0|-0.887|0.698|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.698|-0.887|1.0000
71077896|NCT02913105|141664398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.87||||0.0324|TWO_SIDED|90.0|0.78|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 7||0.97|0.78|0.0324
71105255|NCT01561469|141717842|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Analysis for superinfections category reported.||||1.00
71105256|NCT01561469|141717842|SUPERIORITY_OR_OTHER|||||||0.759|TWO_SIDED||||||Chi-squared|||Analysis for colonization category reported.||||0.759
71105257|NCT01561469|141717843|SUPERIORITY_OR_OTHER|||||||0.773|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.773
70851034|NCT01584440|141190381|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.22|||||TWO_SIDED||||||||Hallucinations Domain; Day 70|||||
70931399|NCT01074294|141362885|SUPERIORITY||Risk Ratio (RR)|0.99||||0.986|TWO_SIDED|95.0|0.46|2.13||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 7||2.13|0.46|0.9860
70931400|NCT01074294|141362885|SUPERIORITY||Risk Ratio (RR)|1.01||||0.9858|TWO_SIDED|95.0|0.52|1.95||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 8||1.95|0.52|0.9858
70931401|NCT01074294|141362885|SUPERIORITY||Risk Ratio (RR)|1.02||||0.9466|TWO_SIDED|95.0|0.58|1.78||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 9||1.78|0.58|0.9466
70931402|NCT01074294|141362885|SUPERIORITY||Risk Ratio (RR)|1.12||||0.6962|TWO_SIDED|95.0|0.63|2.0||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 10||2.00|0.63|0.6962
70931403|NCT01074294|141362885|SUPERIORITY||Risk Ratio (RR)|0.93||||0.7637|TWO_SIDED|95.0|0.57|1.51||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 11||1.51|0.57|0.7637
70931404|NCT01074294|141362886|SUPERIORITY||Risk Ratio (RR)|1.3||||0.3631|TWO_SIDED|95.0|0.73|2.33||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 6||2.33|0.73|0.3631
70931405|NCT01074294|141362886|SUPERIORITY||Risk Ratio (RR)|1.35||||0.2786|TWO_SIDED|95.0|0.78|2.35||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 7||2.35|0.78|0.2786
71105258|NCT01561469|141717844|SUPERIORITY_OR_OTHER|||||||0.823|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.823
71105259|NCT01561469|141717845|SUPERIORITY_OR_OTHER|||||||0.276|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.276
71105260|NCT01561469|141717846|SUPERIORITY_OR_OTHER|||||||0.512|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.512
71105261|NCT03189719|141717855|SUPERIORITY||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.43|0.75|||Stratified Log-Rank|||OS in ESCC PD-L1 CPS ≥10 participants of the pembrolizumab + SOC arm was compared to OS in ESCC PD-L1 CPS ≥10 participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||0.75|0.43|<0.0001
71105262|NCT03189719|141717856|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0006|TWO_SIDED|95.0|0.6|0.88|||Stratified Log-Rank|||OS in ESCC participants of the pembrolizumab + SOC arm was compared to OS in ESCC participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||0.88|0.60|0.0006
71105263|NCT03189719|141717857|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.49|0.78|||Stratified Log-Rank|||OS in PD-L1 CPS ≥10 participants of the pembrolizumab + SOC arm was compared to OS in PD-L1 CPS ≥10 participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||0.78|0.49|<0.0001
71105264|NCT03189719|141717858|SUPERIORITY||Hazard Ratio (HR)|0.73|||<|0.0001|TWO_SIDED|95.0|0.62|0.86|||Stratified Log-Rank|||OS in all participants of the pembrolizumab + SOC arm was compared to OS in all participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World), tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma), and ECOG performance status (0 versus 1).||0.86|0.62|<0.0001
71105265|NCT03189719|141717859|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.54|0.78|||Stratified Log-Rank|||PFS in ESCC participants of the pembrolizumab + SOC arm was compared to PFS in ESCC participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||0.78|0.54|<0.0001
71105266|NCT03189719|141717860|SUPERIORITY||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.41|0.65|||Stratified Log-Rank|||PFS in PD-L1 CPS ≥10 participants of the pembrolizumab + SOC arm was compared to PFS in PD-L1 CPS ≥10 participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||0.65|0.41|<0.0001
71105267|NCT03189719|141717861|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.55|0.76|||Stratified Log-Rank|||PFS in all participants of the pembrolizumab + SOC arm was compared to PFS in all participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World), tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma), and ECOG performance status (0 versus 1).||0.76|0.55|<0.0001
71105268|NCT03189719|141717862|SUPERIORITY||Difference in Percentage|15.8|||<|0.0001|TWO_SIDED|95.0|9.0|22.5|||One-sided p-value|||ORR in all participants of the pembrolizumab + SOC arm was compared to ORR in all participants of the placebo + SOC arm based on the Miettinen \& Nurminen method stratified by geographic region (Asia versus Rest of the World), tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma), and ECOG performance status (0 versus 1).||22.5|9.0|<0.0001
71105269|NCT03189719|141717863|OTHER||Difference in Percentage|22.8|||<|0.0001|TWO_SIDED|95.0|11.6|33.4|||One-sided p-value|||ORR in ESCC PD-L1 CPS ≥10 participants of the pembrolizumab + SOC arm was compared to ORR in ESCC PD-L1 CPS ≥10 participants of the placebo + SOC arm based on the Miettinen \& Nurminen method stratified by geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||33.4|11.6|<0.0001
71105270|NCT03189719|141717864|OTHER||Difference in Percentage|12.8||||0.0009|TWO_SIDED|95.0|4.7|20.7|||One-sided p-value|||ORR in ESCC participants of the pembrolizumab + SOC arm was compared to ORR in ESCC participants of the placebo + SOC arm based on the Miettinen \& Nurminen method stratified by geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||20.7|4.7|0.0009
71105271|NCT03189719|141717865|OTHER||Difference in Percentage|24.0|||<|0.0001|TWO_SIDED|95.0|14.3|33.2|||One-sided p-value|||ORR in PD-L1 CPS ≥10 participants of the pembrolizumab + SOC arm was compared to ORR in PD-L1 CPS ≥10 participants of the placebo + SOC arm based on the Miettinen \& Nurminen method stratified by geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||33.2|14.3|<0.0001
70851035|NCT01584440|141190381|SUPERIORITY||OLS Z-statistic|-0.32||||0.749|TWO_SIDED||||||ANCOVA|Depression/Dysphoria Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.749
71105272|NCT03189719|141717872|OTHER||Difference in LS Means|-0.1||||0.953|TWO_SIDED|95.0|-3.4|3.2|||constrained Longitudinal Data Analysis|||Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between treatment arms based on a constrained longitudinal data analysis (cLDA) model with the EORTC-QLQ-C30 GHS/QoL scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma) and ECOG performance status (0 versus 1).||3.20|-3.40|0.9530
70851036|NCT01584440|141190381|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.07|||||TWO_SIDED||||||||Depression/Dysphoria Domain; Day 36|||||
70851037|NCT01584440|141190381|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.1|||||TWO_SIDED||||||||Depression/Dysphoria Domain; Day 70|||||
70941603|NCT04748445|141383932|OTHER||Slope|0.194|||<|0.0001|TWO_SIDED|90.0|0.148|0.241|||Mixed Models Analysis|||Headache||0.241|0.148|<.0001
70931406|NCT01074294|141362886|SUPERIORITY||Risk Ratio (RR)|1.08||||0.7062|TWO_SIDED|95.0|0.72|1.62||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 8||1.62|0.72|0.7062
70931407|NCT01074294|141362886|SUPERIORITY||Risk Ratio (RR)|0.95||||0.7844|TWO_SIDED|95.0|0.67|1.35||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 9||1.35|0.67|0.7844
70931408|NCT01074294|141362886|SUPERIORITY||Risk Ratio (RR)|1.07||||0.694|TWO_SIDED|95.0|0.77|1.48||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 10||1.48|0.77|0.6940
70931409|NCT01074294|141362886|SUPERIORITY||Risk Ratio (RR)|1.03||||0.8697|TWO_SIDED|95.0|0.76|1.39||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 11||1.39|0.76|0.8697
70931410|NCT03885232|141362899|SUPERIORITY|We applied a mixed zero-inflated beta regression model that included a fixed binary factor for treatment arm, a random effect for clinic to account for correlation within clinics, and unbalanced parent demographics across study arms.|Incidence Rate Ratio (IRR)|1.04||||0.9|TWO_SIDED|95.0|0.68|1.6|||Generalized linear mixed effects regress|Generalized linear mixed effects regression models||||1.60|0.68|0.9
70931411|NCT03885232|141362900|SUPERIORITY||Other|1.0|||<|0.05|TWO_SIDED||||||Chi-squared|||Calculated individual survey means for vaccine hesitant parents who participated in the survey. Survey consisted of 15 questions with a 7-point Likert scale. We then created a dichotomous variable where 1 = mean \> or equal to 6; 0 = mean \< 6.||||<0.05
70931412|NCT03885232|141362901|SUPERIORITY||Odds Ratio (OR)|1.92|||<|0.05|TWO_SIDED|95.0|0.66|5.64|||Generalized linear mixed effects regress|Adjusted for: study arm, study period (pre vs. post), years in practice, provider type, interaction between study arm and study period||"1. Ho: No difference in the proportion of clinicians using presumptive and Motivational Interviewing techniques between intervention and control.~2. Ho: No difference in the proportion of clinicians time spent talking to vaccine hesitant parents between intervention and control."||5.64|0.66|<0.05
70931413|NCT03260569|141362904|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70931414|NCT03509909|141362926|SUPERIORITY|||||||0.74|||||||Mixed Models Analysis|||||||0.74
71105273|NCT03189719|141717873|OTHER||Difference in LS Means|-1.95||||0.5053|TWO_SIDED|95.0|-7.72|3.82|||constrained Longitudinal Data Analysis|||Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between treatment arms based on a cLDA model with the EORTC-QLQ-C30 GHS/QoL scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||3.82|-7.72|0.5053
71105274|NCT03189719|141717874|OTHER||Difference in LS Means|-0.06||||0.9742|TWO_SIDED|95.0|-3.93|3.81|||constrained Longitudinal Data Analysis|||Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between treatment arms based on a cLDA model with the EORTC-QLQ-C30 GHS/QoL scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||3.81|-3.93|0.9742
71105275|NCT03189719|141717875|OTHER||Difference in LS Means|-1.77||||0.481|TWO_SIDED|95.0|-6.71|3.17|||constrained Longitudinal Data Analysis|||Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between treatment arms based on a cLDA model with the EORTC-QLQ-C30 GHS/QoL scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||3.17|-6.71|0.4810
70851038|NCT01584440|141190381|SUPERIORITY||OLS Z-statistic|-0.81||||0.416|TWO_SIDED||||||ANCOVA|Anxiety Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.416
70851039|NCT01584440|141190381|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.28|||||TWO_SIDED||||||||Anxiety Domain; Day 36|||||
70851040|NCT01584440|141190381|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.81|||||TWO_SIDED||||||||Anxiety Domain|||||
70931415|NCT03593356|141362934|SUPERIORITY||Slope|-0.427|STANDARD_ERROR_OF_MEAN|1.179||0.717|TWO_SIDED|||||We use OLS regression with site fixed effects and baseline covariates. We report unadjusted p-values.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.717
70931416|NCT03593356|141362937|SUPERIORITY||Slope|-0.012|STANDARD_ERROR_OF_MEAN|0.043||0.784|TWO_SIDED|||||We reported the Westfall-Young adjusted p-value, using OLS regression with site fixed effects and baseline covariates. The unadjusted p-value was 0.789.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.784
70931417|NCT03593356|141362938|SUPERIORITY||Slope|0.578|STANDARD_ERROR_OF_MEAN|0.807||0.474|TWO_SIDED|||||We use OLS regression with site fixed effects and baseline covariates. We report unadjusted p-values.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.474
70941604|NCT04748445|141383932|OTHER||Slope|0.103||||0.0002|TWO_SIDED|90.0|0.059|0.148|||Mixed Models Analysis|||Loss of taste or smell||0.148|0.059|0.0002
70941605|NCT04748445|141383932|OTHER||Slope|0.181|||<|0.0001|TWO_SIDED|90.0|0.137|0.226|||Mixed Models Analysis|||Muscle pain||0.226|0.137|<.0001
70931418|NCT03593356|141362945|SUPERIORITY||Slope|0.234|STANDARD_ERROR_OF_MEAN|0.882||0.871|TWO_SIDED|||||We reported the Westfall-Young adjusted p-value, using OLS regression with site fixed effects and baseline covariates. The unadjusted p-value was 0.791.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.871
70941606|NCT04748445|141383932|OTHER||Slope|0.044|||<|0.0001|TWO_SIDED|90.0|0.028|0.06|||Mixed Models Analysis|||Nausea||0.060|0.028|<.0001
70941607|NCT04748445|141383932|OTHER||Slope|0.03||||0.0007|TWO_SIDED|90.0|0.016|0.044|||Mixed Models Analysis|||Rigors||0.044|0.016|0.0007
71017140|NCT03692078|141541642|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.444||||0.6018|TWO_SIDED|95.0|-1.237|0.349|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.349|-1.237|0.6018
71017141|NCT03692078|141541642|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.645||||0.2935|TWO_SIDED|95.0|-1.536|0.246|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||0.246|-1.536|0.2935
71017142|NCT03692078|141541642|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.218||||0.0023|TWO_SIDED|95.0|-2.12|-0.315|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.315|-2.120|0.0023
71017143|NCT03692078|141541642|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.844||||0.0669|TWO_SIDED|95.0|-1.723|0.035|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||0.035|-1.723|0.0669
71017144|NCT03692078|141541642|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.539|||<|0.0001|TWO_SIDED|95.0|-2.438|-0.64|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.640|-2.438|<.0001
71017145|NCT03692078|141541642|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.658||||0.212|TWO_SIDED|95.0|-0.192|1.509|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.509|-0.192|0.2120
71017146|NCT03692078|141541642|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.778||||0.0993|TWO_SIDED|95.0|-0.087|1.642|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.642|-0.087|0.0993
71077897|NCT02913105|141664398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.85||||0.0291|TWO_SIDED|90.0|0.76|0.96|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 14||0.96|0.76|0.0291
70941608|NCT04748445|141383932|OTHER||Slope|0.159|||<|0.0001|TWO_SIDED|90.0|0.123|0.195|||Mixed Models Analysis|||Runny nose||0.195|0.123|<.0001
70931419|NCT03593356|141362946|SUPERIORITY||Slope|0.021|STANDARD_ERROR_OF_MEAN|0.046||0.871|TWO_SIDED|||||We reported the Westfall-Young adjusted p-value, using OLS regression with site fixed effects and baseline covariates. The unadjusted p-value was 0.646.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.871
71017147|NCT03692078|141541642|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.649||||0.2347|TWO_SIDED|95.0|-0.211|1.509|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.509|-0.211|0.2347
71017148|NCT03692078|141541642|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.915||||0.032|TWO_SIDED|95.0|0.052|1.778|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.778|0.052|0.0320
71017149|NCT03692078|141541642|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.099||||1|TWO_SIDED|95.0|-0.849|1.047|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||1.047|-0.849|1.0000
71017150|NCT03692078|141541642|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.141||||0.9999|TWO_SIDED|95.0|-0.82|1.103|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||1.103|-0.820|0.9999
70931420|NCT03593356|141362947|SUPERIORITY||Slope|0.139|STANDARD_ERROR_OF_MEAN|0.86||0.872|TWO_SIDED|||||We use OLS regression with site fixed effects and baseline covariates. We report unadjusted p-values.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.872
70931421|NCT03593356|141362950|SUPERIORITY||Slope|0.133|STANDARD_ERROR_OF_MEAN|0.1||0.184|TWO_SIDED|||||We use OLS regression with site fixed effects and baseline covariates. We report unadjusted p-values.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.184
70931422|NCT03593356|141362953|SUPERIORITY||Slope|0.138|STANDARD_ERROR_OF_MEAN|0.173||0.415|TWO_SIDED|||||We reported the Westfall-Young adjusted p-value, using OLS regression with site fixed effects and baseline covariates. The unadjusted p-value was 0.427.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.415
70931423|NCT03593356|141362954|SUPERIORITY||Slope|0.086|STANDARD_ERROR_OF_MEAN|0.14||0.567|TWO_SIDED|||||We reported the Westfall-Young adjusted p-value, using OLS regression with site fixed effects and baseline covariates. The unadjusted p-value was 0.541.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.567
70931424|NCT03777657|141363197|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0056|TWO_SIDED|95.0|0.59|0.94||The superiority boundary at the primary overall survival analysis was predefined using the O'Brien-Fleming boundary approximated using the Hwang-Shih-DeCani spending function at 0.0092.|One-sided Log Rank Test|One-Sided Log-Rank Test stratified by regions (Asia versus Europe/North America) and presence of peritoneal metastasis (yes vs no).|The stratified hazard ratio and two-sided 95% confidence interval were estimated using a Cox proportional hazard regression model, including treatment arm as a covariate, and region and presence of peritoneal metastasis as strata.|||0.94|0.59|0.0056
70931425|NCT03777657|141363198|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0011|TWO_SIDED|95.0|0.7|0.92||The one sided P value boundary for superiority of overall survival in all randomized participants at final analysis was 0.0226 based on 776 actual observed deaths.|One-Sided Log-Rank Test|One-Sided Log-Rank test stratified by region (Asia vs Europe/North America), PD-L1 expression (\<5% vs ≥5%), and presence of peritoneal metastasis.|The stratified hazard ratio and two-sided 95% confidence interval were estimated using a Cox proportional hazard regression model, including treatment arm as a covariate, and region, PD-L1 expression, and presence of peritoneal metastasis as strata.|||0.92|0.70|0.0011
70931426|NCT03777657|141363199|OTHER||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.56|0.83|||||The stratified hazard ratio and two-sided 95% confidence interval were estimated using a Cox proportional hazard regression model, including treatment arm as a covariate, and region and presence of peritoneal metastasis as strata.|||0.83|0.56|
70931427|NCT03777657|141363200|OTHER||Odds Ratio (OR)|1.45|||||TWO_SIDED|95.0|1.03|2.04|||||Odds ratio between arms weas calculated using the Cochran-Mantel-Haenszel method, stratified by regions (Asia versus Europe/North America) and presence of peritoneal metastasis.|||2.04|1.03|
70931428|NCT03777657|141363201|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.67|0.9|||||The stratified hazard ratio and two-sided 95% confidence interval were estimated using a Cox proportional hazard regression model, including treatment arm as a covariate, and region, PD-L1 expression, and presence of peritoneal metastasis as strata.|||0.90|0.67|
70931429|NCT03777657|141363202|OTHER||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|1.03|1.72|||||Odds ratio between arms were calculated using the Cochran-Mantel-Haenszel method, stratified by regions (Asia versus Europe/North America), PD-L1 expression and presence of peritoneal metastasis.|||1.72|1.03|
70931430|NCT03777657|141363205|OTHER||Least Squares (LS) Mean Difference|1.8|||||TWO_SIDED|95.0|-0.33|3.94|||||Mixed effect model analysis with QLQ-C30 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in Global Health Status/QoL at Cycle 4||3.94|-0.33|
70931431|NCT03777657|141363205|OTHER||LS Mean Difference|2.52|||||TWO_SIDED|95.0|0.29|4.74|||||Mixed effect model analysis with QLQ-C30 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in Global Health Status/QoL at Cycle 6||4.74|0.29|
70851041|NCT01584440|141190381|SUPERIORITY||OLS Z-statistic|-1.07||||0.287|TWO_SIDED||||||ANCOVA|Euphoria/Elation Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.287
70851042|NCT01584440|141190381|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.04|||||TWO_SIDED||||||||Euphoria/Elation Domain; Day 36|||||
70851043|NCT01584440|141190381|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.34|||||TWO_SIDED||||||||Euphoria/Elation Domain; Day 70|||||
70931432|NCT03777657|141363205|OTHER||LS Mean Difference|1.44|||||TWO_SIDED|95.0|-0.27|3.16||||||Analysis of Change from Baseline in Physical Functioning at Cycle 4||3.16|-0.27|
70931433|NCT03777657|141363205|OTHER||LS Mean Difference|2.46|||||TWO_SIDED|95.0|0.49|4.43|||||Mixed effect model analysis with QLQ-C30 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in Physical Functioning at Cycle 6||4.43|0.49|
70931434|NCT03777657|141363206|OTHER||LS Mean Difference|-1.32|||||TWO_SIDED|95.0|-3.79|1.15|||||Mixed effect model analysis with QLQ-C30 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in Fatigue at Cycle 4||1.15|-3.79|
70931435|NCT03777657|141363206|OTHER||LS Mean Difference|-3.01|||||TWO_SIDED|95.0|-5.78|-0.24|||||Mixed effect model analysis with QLQ-C30 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in Fatigue at Cycle 6||-0.24|-5.78|
70931436|NCT03777657|141363207|OTHER||LS Mean Difference|-1.11|||||TWO_SIDED|95.0|-2.53|0.31|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Index-Score at Cycle 4||0.31|-2.53|
70931437|NCT03777657|141363207|OTHER||LS Mean Difference|-1.62|||||TWO_SIDED|95.0|-3.12|-0.12|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Index-Score at Cycle 6||-0.12|-3.12|
70931438|NCT03777657|141363207|OTHER||LS Mean Difference|-1.51|||||TWO_SIDED|95.0|-3.13|0.11|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Dysphagia/Odynophagia Scale at Cycle 4||0.11|-3.13|
70931439|NCT03777657|141363207|OTHER||LS Mean Difference|-0.77|||||TWO_SIDED|95.0|-2.31|0.76|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Dysphagia/Odynophagia Scale at Cycle 6||0.76|-2.31|
70931440|NCT03777657|141363207|OTHER||LS Mean Difference|-2.23|||||TWO_SIDED|95.0|-4.26|-0.2|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Pain/Discomfort Scale at Cycle 4||-0.20|-4.26|
70931441|NCT03777657|141363207|OTHER||LS Mean Difference|-1.88|||||TWO_SIDED|95.0|-4.03|0.27|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Pain/Discomfort Scale at Cycle 6||0.27|-4.03|
70931442|NCT03777657|141363207|OTHER||LS Mean Difference|-0.93|||||TWO_SIDED|95.0|-2.85|0.99|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Dietary Restrictions Scale at Cycle 4||0.99|-2.85|
70931443|NCT03777657|141363207|OTHER||LS Mean Difference|-1.32|||||TWO_SIDED|95.0|-3.42|0.77|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Dietary Restrictions Scale at Cycle 6||0.77|-3.42|
70931444|NCT03777657|141363207|OTHER||LS Mean Difference|-1.59|||||TWO_SIDED|95.0|-3.28|0.09|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Upper Gastro-Intestinal Symptoms at Cycle 4||0.09|-3.28|
70931445|NCT03777657|141363207|OTHER||LS Mean Difference|-1.74|||||TWO_SIDED|95.0|-3.55|0.06|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Upper Gastro-Intestinal Symptoms at Cycle 6||0.06|-3.55|
70931446|NCT03867201|141363239|SUPERIORITY||Mean Difference (Net)|-1.57|STANDARD_ERROR_OF_MEAN|0.64||0.015|TWO_SIDED|95.0|-2.83|-0.3|||Mixed Models Analysis|||||-0.30|-2.83|0.015
70931447|NCT01983683|141363245|NON_INFERIORITY|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above -10%|Difference between 2 proportions|-4.7|||||TWO_SIDED|95.0|-10.7|1.3|||||CI for the difference between two proportions are estimated using the Wilson's score method|||1.3|-10.7|
70931448|NCT01983683|141363245|NON_INFERIORITY|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above -10%|Difference between 2 proportions|-3.6|||||TWO_SIDED|95.0|-9.6|2.3|||||CI for the difference between two proportions are estimated using the Wilson's score method|Sensitivity analysis with imputation for a single day with missing UBM data between one day before end-of-treatment (EOT) and 2 days after EOT||2.3|-9.6|
70931449|NCT01983683|141363246|NON_INFERIORITY|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above -10%|Difference between 2 proportions|-4.9|||||TWO_SIDED|95.0|-10.4|0.6|||||CI for the difference between two proportions are estimated using the Wilson' score method|||0.6|-10.4|
70931450|NCT01983683|141363247|SUPERIORITY|Superiority of cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above zero|Difference between 2 proportions|1.7|||||TWO_SIDED|95.0|-6.1|9.4|||||CI for the difference between two proportions are estimated using the Wilson's score method|||9.4|-6.1|
70941609|NCT04748445|141383932|OTHER||Slope|0.222|||<|0.0001|TWO_SIDED|90.0|0.168|0.277|||Mixed Models Analysis|||Sore throat||0.277|0.168|<.0001
71105276|NCT03189719|141717876|OTHER||Difference in LS Means|-5.54||||0.0436|TWO_SIDED|95.0|-10.93|-0.16|||constrained Longitudinal Data Analysis|||DYSPHAGIA: Change from baseline to Week 18 in EORTC QLQ-OES18 Dysphagia subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma) and ECOG performance status (0 versus 1).||-0.16|-10.93|0.0436
71105277|NCT03189719|141717876|OTHER||Difference in LS Means|-2.94||||0.0487|TWO_SIDED|95.0|-5.86|-0.02|||constrained Longitudinal Data Analysis|||PAIN: Change from baseline to Week 18 in EORTC QLQ-OES18 Pain subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma) and ECOG performance status (0 versus 1).||-0.02|-5.86|0.0487
71105278|NCT03189719|141717876|OTHER||Difference in LS Means|-0.93||||0.5932|TWO_SIDED|95.0|-4.36|2.49|||constrained Longitudinal Data Analysis|||REFLUX: Change from baseline to Week 18 in EORTC QLQ-OES18 Reflux subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma) and ECOG performance status (0 versus 1).||2.49|-4.36|0.5932
71105279|NCT03189719|141717877|OTHER||Difference in LS Means|-8.68||||0.0564|TWO_SIDED|95.0|-17.59|0.24|||constrained Longitudinal Data Analysis|||DYSPHAGIA: Change from baseline to Week 18 in EORTC QLQ-OES18 Dysphagia subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||0.24|-17.59|0.0564
71105280|NCT03189719|141717877|OTHER||Difference in LS Means|-2.13||||0.3813|TWO_SIDED|95.0|-6.93|2.66|||constrained Longitudinal Data Analysis|||PAIN: Change from baseline to Week 18 in EORTC QLQ-OES18 Pain subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||2.66|-6.93|0.3813
71105281|NCT03189719|141717877|OTHER||Difference in LS Means|-5.11||||0.0816|TWO_SIDED|95.0|-10.86|0.65|||constrained Longitudinal Data Analysis|||REFLUX: Change from baseline to Week 18 in EORTC QLQ-OES18 Reflux subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||0.65|-10.86|0.0816
71105282|NCT03189719|141717878|OTHER||Difference in LS Means|-4.49||||0.1632|TWO_SIDED|95.0|-10.81|1.83|||constrained Longitudinal Data Analysis|||DYSPHAGIA: Change from baseline to Week 18 in EORTC QLQ-OES18 Dysphagia subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||1.83|-10.81|0.1632
71105283|NCT03189719|141717878|OTHER||Difference in LS Means|-1.71||||0.3259|TWO_SIDED|95.0|-5.12|1.71|||constrained Longitudinal Data Analysis|||PAIN: Change from baseline to Week 18 in EORTC QLQ-OES18 Pain subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||1.71|-5.12|0.3259
71105284|NCT03189719|141717878|OTHER||Difference in LS Means|-1.5||||0.4598|TWO_SIDED|95.0|-5.47|2.48|||constrained Longitudinal Data Analysis|||REFLUX: Change from baseline to Week 18 in EORTC QLQ-OES18 Reflux subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||2.48|-5.47|0.4598
70851044|NCT01584440|141190381|SUPERIORITY||OLS Z-statistic|-1.31||||0.191|TWO_SIDED||||||ANCOVA|Apathy/Indifference Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.191
70931451|NCT01983683|141363248|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.7794|TWO_SIDED|95.0|0.86|1.24||two-sided p-value (alpha 5%) based on log-rank test stratified by first occurrence / first recurrence and geographical region.|Log Rank|||||1.24|0.86|0.7794
70931452|NCT01983683|141363249|SUPERIORITY||Least Square Mean difference|-0.044||||0.6871|TWO_SIDED|95.0|-0.26|0.17||Two-sided 5% alpha level was used|ANOVA|ANOVA model for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12.|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the diarrhea domain scores||0.17|-0.26|0.6871
70851045|NCT01584440|141190381|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.16|||||TWO_SIDED||||||||Apathy/Indifference Domain; Day 36|||||
70851046|NCT01584440|141190381|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.77|||||TWO_SIDED||||||||Apathy/Indifference Domain; Day 36|||||
70941610|NCT04748445|141383932|OTHER||Slope|0.337|||<|0.0001|TWO_SIDED|90.0|0.264|0.411|||Mixed Models Analysis|||Stuffy/blocked nose||0.411|0.264|<.0001
71017151|NCT03692078|141541642|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.101||||1|TWO_SIDED|95.0|-1.038|0.837|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.837|-1.038|1.0000
71017152|NCT03692078|141541642|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.18||||0.9995|TWO_SIDED|95.0|-1.139|0.779|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.779|-1.139|0.9995
71017153|NCT03692078|141541644|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.12|||<|0.0001|TWO_SIDED|95.0|2.964|3.276|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||3.276|2.964|<.0001
71017154|NCT03692078|141541644|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.141|||<|0.0001|TWO_SIDED|95.0|2.953|3.328|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||3.328|2.953|<.0001
71017155|NCT03692078|141541644|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.658|||<|0.0001|TWO_SIDED|95.0|2.511|2.806|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||2.806|2.511|<.0001
71017156|NCT03692078|141541644|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.638|||<|0.0001|TWO_SIDED|95.0|2.458|2.817|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||2.817|2.458|<.0001
71017157|NCT03692078|141541644|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.754|||<|0.0001|TWO_SIDED|95.0|2.604|2.903|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||2.903|2.604|<.0001
71077898|NCT02913105|141664398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.5755|TWO_SIDED|90.0|0.84|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 28||1.09|0.84|0.5755
70851047|NCT01584440|141190381|SUPERIORITY||OLS Z-statistic|-1.1||||0.271|TWO_SIDED||||||ANCOVA|Disinhibition Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.271
70851048|NCT01584440|141190381|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.22|||||TWO_SIDED||||||||Disinhibition Domain; Day 36|||||
70941611|NCT04748445|141383932|OTHER||Slope|0.005||||0.0053|TWO_SIDED|90.0|0.002|0.007|||Mixed Models Analysis|||Vomiting||0.007|0.002|0.0053
70851049|NCT01584440|141190381|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.37|||||TWO_SIDED||||||||Disinhibition Domain; Day 70|||||
70851050|NCT01584440|141190381|SUPERIORITY||OLS Z-statistic|-2.18||||0.029|TWO_SIDED||||||ANCOVA|Irritability/Lability Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.029
70931453|NCT01983683|141363249|SUPERIORITY||Least Square Mean difference|0.025||||0.7833|TWO_SIDED|95.0|-0.15|0.2||Two-sided 5% alpha level was used|ANOVA|ANOVA model for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12.|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the abdominal symptoms domain scores||0.20|-0.15|0.7833
70931454|NCT01983683|141363249|SUPERIORITY||Least Square Mean difference|0.061||||0.4145|TWO_SIDED|95.0|-0.09|0.21||Two-sided 5% alpha level was used|ANOVA|ANOVA model for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12.|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the other symptoms domain scores||0.21|-0.09|0.4145
70931455|NCT01983683|141363250|OTHER||Difference between 2 proportions|-1.1|||||TWO_SIDED|95.0|-6.5|4.2|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis||4.2|-6.5|
71017158|NCT03692078|141541644|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.652|||<|0.0001|TWO_SIDED|95.0|2.471|2.832|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||2.832|2.471|<.0001
71017159|NCT03692078|141541644|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.703|||<|0.0001|TWO_SIDED|95.0|1.517|1.889|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||1.889|1.517|<.0001
71017160|NCT03692078|141541644|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.637|||<|0.0001|TWO_SIDED|95.0|1.41|1.865|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||1.865|1.410|<.0001
71017161|NCT03692078|141541644|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.656|||<|0.0001|TWO_SIDED|95.0|1.472|1.839|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||1.839|1.472|<.0001
71050737|NCT03276221|141608084|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.09||0.369|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the verbal recognition memory module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making a correct choice for the abstinence group above and beyond the monitoring group (positive values indicate higher memory performance for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.369
71050738|NCT03276221|141608085|SUPERIORITY||Slope|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.647|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the verbal recognition memory module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making a correct choice for the abstinence group above and beyond the monitoring group (positive values indicate higher memory performance for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.647
70931456|NCT01983683|141363251|OTHER||Difference between 2 proportions|-1.6|||||TWO_SIDED|95.0|-6.5|3.3|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis||3.3|-6.5|
70931457|NCT01983683|141363252|OTHER||Difference between 2 proportions|8.8|||||TWO_SIDED|95.0|1.1|16.4|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis||16.4|1.1|
70941612|NCT04748445|141383932|OTHER||Slope|0.049||||0.0057|TWO_SIDED|90.0|0.02|0.078|||Mixed Models Analysis|||Wheezing||0.078|0.020|0.0057
71017162|NCT03692078|141541644|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.485|||<|0.0001|TWO_SIDED|95.0|1.259|1.711|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||1.711|1.259|<.0001
71017163|NCT03692078|141541644|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.713|||<|0.0001|TWO_SIDED|95.0|1.532|1.895|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||1.895|1.532|<.0001
71017164|NCT03692078|141541644|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.617|||<|0.0001|TWO_SIDED|95.0|1.397|1.837|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||1.837|1.397|<.0001
71017165|NCT03692078|141541644|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.462||||0.0003|TWO_SIDED|95.0|-0.766|-0.158|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.158|-0.766|0.0003
71017166|NCT03692078|141541644|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.503||||0.0018|TWO_SIDED|95.0|-0.867|-0.139|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.139|-0.867|0.0018
70931458|NCT01983683|141363253|SUPERIORITY|Sensitivity analysis|Difference between 2 proportions|2.7|||||TWO_SIDED|95.0|-5.5|10.9|||||CI for the difference between two proportions are estimated using the Wilson's score method|||10.9|-5.5|
70931459|NCT03400150|141363258|OTHER|||||||0.025|TWO_SIDED|95.0|||||Farrington-Manning|||||||0.025
70931460|NCT05501600|141363259|SUPERIORITY|||||||0.004|||||||Regression, Linear|||||||0.004
70931461|NCT05501600|141363260|SUPERIORITY|||||||0.081616|||||||t-test, 2 sided|||||||0.081616
70931462|NCT04039113|141363268|SUPERIORITY||Rate Ratio|0.83||||0.1042|TWO_SIDED|90.0|0.64|1.06||1-sided p-value|Negative Binomial|||||1.06|0.64|0.1042
70931463|NCT04039113|141363268|SUPERIORITY||Rate Ratio|0.83||||0.2085|TWO_SIDED|95.0|0.61|1.11||2-sided p-value|Negative Binomial|||||1.11|0.61|0.2085
70931464|NCT04538352|141363291|OTHER|p value of contrast difference compared from MDI to Semaglutide group at specific time point, testing whether contrast difference is equal to 0, which means there is no difference between two groups. The determination of statistical significance was made using Bonferroni-adjusted p-value, setting the significance threshold at 0.01 after multiplicity correction.||||||0.009||||||p value is adjusted for the multiple comparison. The significance threshold is set to 0.01.|Bonferroni-adjusted p-value|||"Linear mixed effect model was conducted for each endpoint to assess mean change at each time point, with time, treatment groups, the interaction of treatment groups and time, and baseline variables included and adjusted in each model.~Mean change difference between patients with MDI and those with Semaglutide (MDI - Semaglutide)"||||0.009
70931465|NCT04538352|141363292|OTHER|p value of contrast difference compared from MDI to Semaglutide group at specific time point, testing whether contrast difference is equal to 0, which means there is no difference between two groups. The determination of statistical significance was made using Bonferroni-adjusted p-value, setting the significance threshold at 0.01 after multiplicity correction.|||||<|0.001||||||p value is adjusted for the multiple comparison. The significance threshold is set to 0.01.|Bonferroni-adjusted p-value|||"Linear mixed effect model was conducted for each endpoint to assess mean change at each time point, with time, treatment groups, the interaction of treatment groups and time, and baseline variables included and adjusted in each model.~Mean change difference between patients with MDI and those with Semaglutide (MDI - Semaglutide)"||||<0.001
70931466|NCT00220805|141363325|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED|95.0|||||ANOVA|||The primary efficacy comparison for the change in LogMAR from baseline to endpoint was a two-way analysis of variance (ANOVA) with treatment group and center as fixed factors (main effect model).||||0.49
70931467|NCT00220805|141363326|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED|||||Adjusted for centers (including a Breslow-Day test for homogeneity of odd ratios across centers)|Cochran-Mantel-Haenszel|||||||0.76
71017167|NCT03692078|141541644|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.366||||0.0089|TWO_SIDED|95.0|-0.67|-0.062|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.062|-0.670|0.0089
70931468|NCT00220805|141363327|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Cochran-Mantel-Haenszel|Adjusted for centers (including a Breslow-Day test for homogeneity of odd ratios across centers)||||||0.13
70931469|NCT00220805|141363328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9|TWO_SIDED|95.0|-0.21|0.19|||ANOVA|||||0.19|-0.21|0.90
70931470|NCT00220805|141363330|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||Cochran-Mantel-Haenszel|Adjusted to centers||||||0.74
70931471|NCT01288443|141363343|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤ 0.05.|ANCOVA|||"Each treatment group was compared to placebo using ANCOVA-derived contrasts.~A hierarchical testing procedure was applied to ensure strong control of overall Type-I error rate at 0.05 level. Order was following:~1. Alirocumab 150 mg Q2W versus placebo~2. Alirocumab 300 mg Q4W versus placebo~3. Alirocumab 100 mg Q2W versus placebo~4. Alirocumab 200 mg Q4W versus placebo~5. Alirocumab 50 mg Q2W versus placebo~Testing continued only when high-order test was statistically significant at 5% level"||||<0.0001
70931472|NCT01288443|141363343|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤ 0.05.|ANCOVA|||||||<0.0001
70931473|NCT01288443|141363343|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤ 0.05.|ANCOVA|||||||<0.0001
70931474|NCT01288443|141363343|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤ 0.05.|ANCOVA|||||||<0.0001
70931475|NCT01288443|141363343|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤ 0.05.|ANCOVA|||||||<0.0001
70931476|NCT04327843|141363355|OTHER|This is a prospective study with a repeated measures design.||||||0.001||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed||||||0.001
70931477|NCT04327843|141363356|OTHER|This is a prospective study with a repeated measures design.||||||0.43||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||0.43
70931478|NCT04327843|141363357|OTHER|This is a prospective study with a repeated measures design.||||||0.07||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||0.07
71050739|NCT03276221|141608086|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.09||0.511|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the verbal recognition memory module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making a correct choice for the abstinence group above and beyond the monitoring group (positive values indicate higher memory performance for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.511
71077899|NCT02913105|141664398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.92||||0.307|TWO_SIDED|90.0|0.8|1.05|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 42||1.05|0.80|0.3070
70931479|NCT04327843|141363358|OTHER|This is a prospective study with a repeated measures design.||||||0.1||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||0.10
70931480|NCT04327843|141363359|OTHER|This is a prospective study with a repeated measures design.||||||0.75||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||0.75
70931481|NCT04327843|141363360|OTHER|This is a prospective study with a repeated measures design.||||||1||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||1.00
70931482|NCT04327843|141363362|OTHER|This is a prospective study with a repeated measures design.||||||0.75||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||0.75
70931483|NCT04327843|141363363|OTHER|This is a prospective study with a repeated measures design.||||||0.14||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||0.14
70931484|NCT02438137|141363380|SUPERIORITY|In multiple linear regression models, the effect of DMF treatment on mean RDI change (beta-coefficient) was -11.3 respiratory events per hour (p=0.0124).|beta-coefficient for treatment effect|-11.3|STANDARD_ERROR_OF_MEAN|4.3||0.0124|TWO_SIDED||||||Regression, Linear|||Multiple linear regression models were used to calculate treatment effect (DMF or placebo) on mean RDI change, controlling for change in age, gender, BMI, time spent in supine sleep, and time spent in REM sleep.|A mixed effects model, which treated RDI as a repeated measure and used individual ID as random effect, adjusted for age, gender, BMI, time spent in supine sleep, was also conducted. In this model, the effect of DMF compared to placebo, controlling for all other covariates, is a 28% decrease in Month 4 RDI (p=0.033).|||0.0124
70931485|NCT04868617|141363385|SUPERIORITY||Mean Difference (Final Values)|-0.2|||=|0.015|TWO_SIDED|95.0|-0.3|-0.03|||Mixed Models Analysis|||||-0.03|-0.3|=0.015
70931486|NCT04868617|141363386|SUPERIORITY||Mean Difference (Final Values)|-0.8|||=|0.035|TWO_SIDED|95.0|-1.5|-0.1|||Mixed Models Analysis|||||-0.1|-1.5|=0.035
70931487|NCT01260896|141363404|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.84|||||TWO_SIDED|90.0|100.54|113.54|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||113.54|100.54|
70931488|NCT01260896|141363405|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.34|||||TWO_SIDED|90.0|100.37|110.55|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||110.55|100.37|
70931489|NCT01260896|141363406|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.12|||||TWO_SIDED|90.0|97.8|108.73|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.73|97.80|
70931490|NCT01260896|141363407|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|114.21|||||TWO_SIDED|90.0|109.29|119.35|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||119.35|109.29|
71017168|NCT03692078|141541644|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.489||||0.0025|TWO_SIDED|95.0|-0.851|-0.126|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.126|-0.851|0.0025
70851051|NCT01584440|141190381|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.7|||||TWO_SIDED||||||||Irritability/Lability Domain; Day 36|||||
71017169|NCT03692078|141541644|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.417|||<|0.0001|TWO_SIDED|95.0|-1.762|-1.072|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.072|-1.762|<.0001
71017170|NCT03692078|141541644|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.504|||<|0.0001|TWO_SIDED|95.0|-1.916|-1.091|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.091|-1.916|<.0001
71017171|NCT03692078|141541644|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.464|||<|0.0001|TWO_SIDED|95.0|-1.804|-1.125|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.125|-1.804|<.0001
70941613|NCT04748445|141383932|OTHER||Slope|2.644|||<|0.0001|TWO_SIDED|90.0|2.101|3.188|||Mixed Models Analysis|||Mean of daily total symptom score||3.188|2.101|<.0001
71017172|NCT03692078|141541644|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.656|||<|0.0001|TWO_SIDED|95.0|-2.065|-1.247|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.247|-2.065|<.0001
70851052|NCT01584440|141190381|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.93|||||TWO_SIDED||||||||Irritability/Lability Domain; Day 70|||||
70931491|NCT01260896|141363408|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|108.26|||||TWO_SIDED|90.0|104.84|111.79|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||111.79|104.84|
71017173|NCT03692078|141541644|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.945|||<|0.0001|TWO_SIDED|95.0|0.617|1.273|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.273|0.617|<.0001
71017174|NCT03692078|141541644|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|1.021|||<|0.0001|TWO_SIDED|95.0|0.628|1.413|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.413|0.628|<.0001
71017175|NCT03692078|141541644|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|1.041|||<|0.0001|TWO_SIDED|95.0|0.712|1.369|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.369|0.712|<.0001
71017176|NCT03692078|141541644|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|1.035|||<|0.0001|TWO_SIDED|95.0|0.644|1.426|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.426|0.644|<.0001
71017177|NCT03692078|141541644|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.01||||1|TWO_SIDED|95.0|-0.376|0.355|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.355|-0.376|1.0000
71017178|NCT03692078|141541644|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.02||||1|TWO_SIDED|95.0|-0.417|0.457|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.457|-0.417|1.0000
71017179|NCT03692078|141541644|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.058||||0.9999|TWO_SIDED|95.0|-0.418|0.303|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.303|-0.418|0.9999
71017180|NCT03692078|141541644|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.132||||0.9669|TWO_SIDED|95.0|-0.566|0.301|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.301|-0.566|0.9669
70931492|NCT01260896|141363409|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.75|||||TWO_SIDED|90.0|92.92|102.85|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.85|92.92|
70931493|NCT00312208|141363410|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.978||95.0|0.86|1.16||Cumulative incidence functions in each treatment group were calculated using non-parametric Kaplan-Meier estimates.|Log Rank|||||1.16|0.86|0.978
70931494|NCT00312208|141363411|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.371||95.0|0.75|1.11||Cumulative incidences calculated in each group using non-parametric Kaplan-Meier estimates.|Log Rank|||||1.11|0.75|0.371
71017181|NCT03692078|141541646|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.442|||<|0.0001|TWO_SIDED|95.0|-1.604|-1.279|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||-1.279|-1.604|<.0001
71105285|NCT03189719|141717879|OTHER||Difference in LS Means|-8.2||||0.0317|TWO_SIDED|95.0|-15.67|-0.73|||constrained Longitudinal Data Analysis|||DYSPHAGIA: Change from baseline to Week 18 in EORTC QLQ-OES18 Dysphagia subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||-0.73|-15.67|0.0317
71017182|NCT03692078|141541646|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.413|||<|0.0001|TWO_SIDED|95.0|-1.576|-1.251|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||-1.251|-1.576|<.0001
71017183|NCT03692078|141541646|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.754|||<|0.0001|TWO_SIDED|95.0|-1.907|-1.6|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||-1.600|-1.907|<.0001
71017184|NCT03692078|141541646|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.816|||<|0.0001|TWO_SIDED|95.0|-1.972|-1.659|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||-1.659|-1.972|<.0001
71017185|NCT03692078|141541646|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.654|||<|0.0001|TWO_SIDED|95.0|-1.81|-1.498|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||-1.498|-1.810|<.0001
71017186|NCT03692078|141541646|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.829|||<|0.0001|TWO_SIDED|95.0|-1.986|-1.673|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||-1.673|-1.986|<.0001
70931495|NCT04612244|141363447|NON_INFERIORITY|"PT will be deemed to be non-inferior to PC if it can be established that the posterior probability Pr(HA \| data) \> Ψeff, where Ψeff is a pre-specified threshold value that controls the one-sided type I error rate (under simulation) at level 0.05. In the absence of missing data, the posterior distributions for PT and PC would be conjugate Beta distributions."||||||0.05|||||||t-test, 1 sided|||"The primary effectiveness endpoint for this study is Treatment Success, which will be analyzed as a test of non-inferiority of the event rate at 12 months using a noninferiority margin of 15%.~The null and alternative hypotheses are:~H0: PT ≤ PC - 0.15 versus HA: PT \> PC - 0.15 where PT is the Treatment Success rate at 12 months in the Pulsed Field Group and PC is the Treatment Success rate at 12 months in the Thermal (Control) Group."||||0.05
70931496|NCT04612244|141363449|SUPERIORITY|"The null and alternative hypotheses are provided below. H0: PT ≤ PC versus HA: PT \> PC where PT is the Treatment Success rate at 12 months in the Pulsed Field Group, and PC is the Treatment Success rate at 12 months in the Thermal Group.~Modeling will be identical primary endpoint and superiority concluded if the posterior probability Pr(HA \| data) \> Ψeff, sup, where the threshold Ψeff,sup is a pre-specified threshold value that controls the one-sided type I error rate at level 0.025."|Median Difference (Final Values)|0.708||||0.025|ONE_SIDED|97.5|||||t-test, 1 sided|||The secondary effectiveness endpoint for the ADVENT Trial is Treatment Superiority uses the same definition as the primary effectiveness endpoint for Treatment Success, but the test is for superiority between MITT subjects in the PFA and Thermal Groups.||||0.025
70931497|NCT03170648|141363453|OTHER|||||||0.02||||||T2 (post) vs.T1(pre)|t-test, 2 sided|||||||0.02
70931498|NCT03500549|141363455|SUPERIORITY|The primary endpoint analysis was a between-treatment-group comparison using a mixed effect model for repeated measures (MMRM). The difference between pegcetacoplan and eculizumab LS mean Hb changes from Baseline at Week 16 was calculated along with its 2-sided 95% confidence interval (CI) and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|3.84|||<|0.0001|TWO_SIDED|95.0|2.33|5.34||Superiority was tested at the 5% level. MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||5.34|2.33|<0.0001
70931499|NCT03500549|141363456|NON_INFERIORITY|Analysis was based on prespecified non-inferiority margins (NIM) and non-inferiority was achieved if the lower confidence limit or upper confidence limit of the 95% CI of the treatment difference met the prespecified NIM of -20%. Stratified Cochran-Mantel Haenszel (CMH) chi-square test was used for treatment comparison and the 95% CI for difference in percentage between treatments is constructed using the stratified (Miettinen-Nurminen) method.|Risk Difference (RD)|0.6253|||<|0.0001|TWO_SIDED|95.0|0.483|0.7677||Non-inferiority was tested at the 2.5% level.|Miettinen-Nurminen|||||0.7677|0.4830|<0.0001
70931500|NCT03500549|141363457|NON_INFERIORITY|Analysis was based on prespecified NIM and non-inferiority was achieved if the lower confidence limit or upper confidence limit of the 95% CI of the treatment difference met the prespecified NIM of 10.|LS mean difference|-163.61|||<|0.0001|TWO_SIDED|95.0|-189.91|-137.3||Non-inferiority was tested at the 2.5% level. MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||-137.30|-189.91|<0.0001
70931501|NCT03500549|141363458|NON_INFERIORITY|Analysis was based on prespecified NIM and non-inferiority was achieved if the lower confidence limit or upper confidence limit of the 95% CI of the treatment difference met the prespecified NIM of 20.|LS mean difference|-4.63||||0.9557|TWO_SIDED|95.0|-181.3|172.04||Non-inferiority was tested at the 2.5% level. MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||172.04|-181.30|0.9557
70931502|NCT03500549|141363459|OTHER|Non-inferiority was not assessed because of the prespecified hierarchical testing. Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|11.87||||0.0005|TWO_SIDED|95.0|5.49|18.25||MRMM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||18.25|5.49|0.0005
70931503|NCT03500549|141363460|OTHER|Stratified CMH chi-square test was used for treatment comparison and the 95% CI for difference in percentage between treatments is constructed using the stratified Miettinen-Nurminen method.|Difference in percentage|0.6745|||||TWO_SIDED|95.0|0.5452|0.8039|||||The difference in percentage and 95% CI is calculated based on stratified Miettinen-Nurminen method stratified by randomization factor so it it is not a direct difference of two reporting groups.|||0.8039|0.5452|
70931504|NCT03500549|141363461|OTHER|Stratified CMH chi-square test was used for treatment comparison and the 95% CI for difference in percentage between treatments is constructed using the stratified Miettinen-Nurminen method.|Difference in percentage|0.6639|||||TWO_SIDED|95.0|0.5309|0.7968|||||The difference in percentage and 95% CI is calculated based on stratified Miettinen-Nurminen method stratified by randomization factor so it it is not a direct difference of two reporting groups.|||0.7968|0.5309|
70931505|NCT03500549|141363462|OTHER|Stratified CMH chi-square test was used for treatment comparison and the 95% CI for difference in percentage between treatments is constructed using the stratified Miettinen-Nurminen method.|Difference in percentage|0.3043|||||TWO_SIDED|95.0|0.1493|0.4593|||||The difference in percentage and 95% CI is calculated based on stratified Miettinen-Nurminen method stratified by randomization factor so it it is not a direct difference of two reporting groups.|||0.4593|0.1493|
70931506|NCT03500549|141363463|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-21.93||||0.0002|TWO_SIDED|95.0|-32.49|-11.36||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||-11.36|-32.49|0.0002
71077900|NCT02913105|141664398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.98||||0.7752|TWO_SIDED|90.0|0.86|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 56||1.12|0.86|0.7752
70851053|NCT01584440|141190381|SUPERIORITY||OLS Z-statistic|-2.21||||0.027|TWO_SIDED||||||ANCOVA|Aberrant Motor Behavior Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.027
70851054|NCT01584440|141190381|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.38|||||TWO_SIDED||||||||Aberrant Motor Behavior Domain; Day 36|||||
70851055|NCT01584440|141190381|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.22|||||TWO_SIDED||||||||Aberrant Motor Behavior Domain; Day 70|||||
70851056|NCT01584440|141190381|SUPERIORITY||OLS Z-statistic|-1.09||||0.274|TWO_SIDED||||||ANCOVA|Sleep/Nighttime Behavior Disorders Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.274
70931507|NCT03500549|141363464|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-0.14||||0.0369|TWO_SIDED|95.0|-0.28|-0.01||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||-0.01|-0.28|0.0369
70931508|NCT03500549|141363465|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|59.1||||0.0069|TWO_SIDED|95.0|16.88|101.32||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||101.32|16.88|0.0069
70931509|NCT03500549|141363466|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|18.62||||0.0486|TWO_SIDED|95.0|0.12|37.13||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Global Health Status/QoL: Difference in LS mean||37.13|0.12|0.0486
70931510|NCT03500549|141363466|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|12.86||||0.0023|TWO_SIDED|95.0|4.86|20.86||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Functional Scales - Physical functioning: Difference in LS mean||20.86|4.86|0.0023
70931511|NCT03500549|141363466|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|24.43||||0.0027|TWO_SIDED|95.0|8.84|40.01||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Functional Scales - Role functioning: Difference in LS mean||40.01|8.84|0.0027
70931512|NCT03500549|141363466|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|4.11||||0.6013|TWO_SIDED|95.0|-11.58|19.8||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Functional Scales - Emotional functioning: Difference in LS mean||19.80|-11.58|0.6013
70931513|NCT03500549|141363466|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|9.56||||0.1792|TWO_SIDED|95.0|-4.52|23.64||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Functional Scales - Cognitive functioning: Difference in LS mean||23.64|-4.52|0.1792
70931514|NCT03500549|141363466|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|11.27||||0.1039|TWO_SIDED|95.0|-2.38|24.92||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Functional Scales - Social functioning: Difference in LS mean||24.92|-2.38|0.1039
70931515|NCT03500549|141363466|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-20.74||||0.0062|TWO_SIDED|95.0|-35.29|-6.19||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Fatigue: Difference in LS mean||-6.19|-35.29|0.0062
70931516|NCT03500549|141363466|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-0.01||||0.9975|TWO_SIDED|95.0|-8.38|8.35||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Nausea and vomiting: Difference in LS mean||8.35|-8.38|0.9975
70941614|NCT04748445|141383933|OTHER||Slope|-1.519|STANDARD_ERROR_OF_MEAN|2.769|<|0.0001|TWO_SIDED|90.0|-1.978|-1.06|||Mixed Models Analysis|||AHH\_Max Phonation Time (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and estimated value it was 10\^-1. For dispersion value it was 10\^-2).||-1.060|-1.978|<.0001
70851057|NCT01584440|141190381|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.57|||||TWO_SIDED||||||||Sleep/Nighttime Behavior disorders Domain; Day 36|||||
70851058|NCT01584440|141190381|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.08|||||TWO_SIDED||||||||Sleep/Nighttime Behavior disorders Domain; Day 70|||||
70851059|NCT01584440|141190381|SUPERIORITY||OLS Z-statistic|-0.65||||0.513|TWO_SIDED||||||ANCOVA|Appetite/Eating Changes Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.513
71017187|NCT03692078|141541646|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-2.184|||<|0.0001|TWO_SIDED|95.0|-2.379|-1.989|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||-1.989|-2.379|<.0001
71017188|NCT03692078|141541646|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-2.27|||<|0.0001|TWO_SIDED|95.0|-2.468|-2.071|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||-2.071|-2.468|<.0001
71017189|NCT03692078|141541646|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-2.413|||<|0.0001|TWO_SIDED|95.0|-2.607|-2.219|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||-2.219|-2.607|<.0001
71017190|NCT03692078|141541646|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-2.349|||<|0.0001|TWO_SIDED|95.0|-2.549|-2.149|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||-2.149|-2.549|<.0001
71017191|NCT03692078|141541646|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-2.227|||<|0.0001|TWO_SIDED|95.0|-2.416|-2.038|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||-2.038|-2.416|<.0001
71017192|NCT03692078|141541646|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-2.154|||<|0.0001|TWO_SIDED|95.0|-2.345|-1.962|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||-1.962|-2.345|<.0001
71017193|NCT03692078|141541646|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.312||||0.0552|TWO_SIDED|95.0|-0.628|0.004|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||0.004|-0.628|0.0552
71017194|NCT03692078|141541646|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.402||||0.0055|TWO_SIDED|95.0|-0.722|-0.083|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.083|-0.722|0.0055
71105286|NCT03189719|141717879|OTHER||Difference in LS Means|-3.57||||0.0945|TWO_SIDED|95.0|-7.77|0.62|||constrained Longitudinal Data Analysis|||PAIN: Change from baseline to Week 18 in EORTC QLQ-OES18 Pain subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||0.62|-7.77|0.0945
70851060|NCT01584440|141190381|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.16|||||TWO_SIDED||||||||Appetite/Eating Changes Domain; Day 36|||||
70931517|NCT03500549|141363466|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-2.76||||0.7554|TWO_SIDED|95.0|-20.36|14.85||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Pain: Difference in LS mean||14.85|-20.36|0.7554
70931518|NCT03500549|141363466|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-14.57||||0.062|TWO_SIDED|95.0|-29.9|0.76||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Dyspnoea: Difference in LS mean||0.76|-29.90|0.0620
70931519|NCT03500549|141363466|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|0.32||||0.9686|TWO_SIDED|95.0|-15.67|16.3||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Insomnia: Difference in LS mean||16.30|-15.67|0.9686
71017195|NCT03692078|141541646|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.212||||0.3834|TWO_SIDED|95.0|-0.53|0.105|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.105|-0.530|0.3834
71017196|NCT03692078|141541646|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.416||||0.0033|TWO_SIDED|95.0|-0.734|-0.099|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.099|-0.734|0.0033
71017197|NCT03692078|141541646|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.743|||<|0.0001|TWO_SIDED|95.0|-1.103|-0.382|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.382|-1.103|<.0001
71017198|NCT03692078|141541646|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.857|||<|0.0001|TWO_SIDED|95.0|-1.22|-0.493|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.493|-1.220|<.0001
71017199|NCT03692078|141541646|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.971|||<|0.0001|TWO_SIDED|95.0|-1.327|-0.616|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.616|-1.327|<.0001
71017200|NCT03692078|141541646|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.936|||<|0.0001|TWO_SIDED|95.0|-1.298|-0.574|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.574|-1.298|<.0001
71017201|NCT03692078|141541646|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.473||||0.0016|TWO_SIDED|95.0|0.133|0.813|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||0.813|0.133|0.0016
71017202|NCT03692078|141541646|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.338||||0.0582|TWO_SIDED|95.0|-0.007|0.683|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||0.683|-0.007|0.0582
71105287|NCT03189719|141717879|OTHER||Difference in LS Means|-4.76||||0.0555|TWO_SIDED|95.0|-9.64|0.11|||constrained Longitudinal Data Analysis|||REFLUX: Change from baseline to Week 18 in EORTC QLQ-OES18 Reflux subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||0.11|-9.64|0.0555
70931520|NCT03500549|141363466|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-7.95||||0.3002|TWO_SIDED|95.0|-23.23|7.33||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Appetite loss: Difference in LS mean||7.33|-23.23|0.3002
71017203|NCT03692078|141541646|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.573|||<|0.0001|TWO_SIDED|95.0|0.232|0.914|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||0.914|0.232|<.0001
71017204|NCT03692078|141541646|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.324||||0.0745|TWO_SIDED|95.0|-0.02|0.668|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||0.668|-0.020|0.0745
71017205|NCT03692078|141541646|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.043||||1|TWO_SIDED|95.0|-0.337|0.422|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.422|-0.337|1.0000
71017206|NCT03692078|141541646|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.116||||0.9759|TWO_SIDED|95.0|-0.501|0.268|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.268|-0.501|0.9759
71017207|NCT03692078|141541646|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.186||||0.7128|TWO_SIDED|95.0|-0.565|0.192|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.192|-0.565|0.7128
70931521|NCT03500549|141363466|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|1.79||||0.8374|TWO_SIDED|95.0|-15.7|19.29||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Constipation: Difference in LS mean||19.29|-15.70|0.8374
70851061|NCT01584440|141190381|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.24|||||TWO_SIDED||||||||Appetite/Eating Changes Domain; Day 70|||||
70931522|NCT03500549|141363466|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-1.38||||0.8775|TWO_SIDED|95.0|-19.28|16.52||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Diarrhoea: Difference in LS mean||16.52|-19.28|0.8775
71017208|NCT03692078|141541646|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.195||||0.6816|TWO_SIDED|95.0|-0.582|0.192|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.192|-0.582|0.6816
70851062|NCT01584440|141190382|SUPERIORITY||OLS Z-statistic|-3.53|||<=|0.001|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||<=0.001
71017209|NCT03692078|141541648|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-0.948|||<|0.0001|TWO_SIDED|95.0|-1.146|-0.75|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||-0.750|-1.146|<.0001
71017210|NCT03692078|141541648|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.019|||<|0.0001|TWO_SIDED|95.0|-1.242|-0.796|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||-0.796|-1.242|<.0001
71017211|NCT03692078|141541648|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.172|||<|0.0001|TWO_SIDED|95.0|-1.358|-0.986|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||-0.986|-1.358|<.0001
71017212|NCT03692078|141541648|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.196|||<|0.0001|TWO_SIDED|95.0|-1.409|-0.983|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||-0.983|-1.409|<.0001
71017213|NCT03692078|141541648|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.049|||<|0.0001|TWO_SIDED|95.0|-1.239|-0.859|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||-0.859|-1.239|<.0001
71017214|NCT03692078|141541648|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.414|-0.986|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||-0.986|-1.414|<.0001
71017215|NCT03692078|141541648|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.337|||<|0.0001|TWO_SIDED|95.0|-1.574|-1.099|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||-1.099|-1.574|<.0001
71077901|NCT02913105|141664398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.88||||0.1803|TWO_SIDED|90.0|0.75|1.03|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 84||1.03|0.75|0.1803
70851063|NCT01584440|141190382|SUPERIORITY||ANCOVA Least Squares Mean Difference|-3.01|||||TWO_SIDED||||||||Day 36|||||
70851064|NCT01584440|141190382|SUPERIORITY||ANCOVA Least Squares Mean Difference|-3.49|||||TWO_SIDED||||||||Day 70|||||
70931523|NCT03500549|141363466|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-7.4||||0.3066|TWO_SIDED|95.0|-21.76|6.95||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Financial difficulties: Difference in LS mean||6.95|-21.76|0.3066
70931524|NCT03500549|141363467|OTHER|Wilcoxon rank-sum test P-value for the comparison between treatments is based on median using stratified non-parametric analysis. The 95% CI is constructed using Hodges-Lehmann Estimation of Location Shift.|Median Difference (Final Values)|3.0|||<|0.0001|TWO_SIDED|95.0|2.0|4.0|||Wilcoxon rank-sum test|||||4.0|2.0|<0.0001
70851065|NCT01584440|141190383|SUPERIORITY||OLS Z-statistic|-3.34||||0.001|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.001
70931525|NCT01371994|141363521|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1745|TWO_SIDED||||||Log Rank|Based on a Log-rank test stratified by (pooled) center and Baseline daily pad usage (≤ 3 and \> 3).||The treatment difference in the primary efficacy variable was tested using a log-rank test stratified by (pooled) center and by Baseline daily pad usage (≤3 and \>3) at a 2-sided significance level of 0.05.||||0.1745
71017216|NCT03692078|141541648|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.345|||<|0.0001|TWO_SIDED|95.0|-1.616|-1.075|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||-1.075|-1.616|<.0001
71017217|NCT03692078|141541648|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.452|||<|0.0001|TWO_SIDED|95.0|-1.685|-1.219|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||-1.219|-1.685|<.0001
71017218|NCT03692078|141541648|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.339|||<|0.0001|TWO_SIDED|95.0|-1.608|-1.071|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||-1.071|-1.608|<.0001
71017219|NCT03692078|141541648|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.348|||<|0.0001|TWO_SIDED|95.0|-1.577|-1.118|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||-1.118|-1.577|<.0001
71017220|NCT03692078|141541648|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.227|||<|0.0001|TWO_SIDED|95.0|-1.488|-0.966|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||-0.966|-1.488|<.0001
71017221|NCT03692078|141541648|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.224||||0.5646|TWO_SIDED|95.0|-0.607|0.16|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||0.160|-0.607|0.5646
71077902|NCT02913105|141664398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.89||||0.2414|TWO_SIDED|90.0|0.76|1.05|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 112 (EOS)||1.05|0.76|0.2414
70851066|NCT01584440|141190383|SUPERIORITY||ANCOVA Least Squares Mean Difference|-2.41|||||TWO_SIDED||||||||Day 36|||||
70931526|NCT01371994|141363522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4833|||||||Cochran-Mantel-Haenszel|Cochran-Mental-Haenszel test stratified by (pooled) center||Comparison at Week 4||||0.4833
70931527|NCT01371994|141363522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5761|||||||Cochran-Mantel-Haenszel|Cochran-Mental-Haenszel test stratified by (pooled) center||Comparison at Week 8||||0.5761
71105288|NCT03330847|141717888|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.9403|TWO_SIDED|90.0|0.63|1.66|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib monotherapy.|Patient Population BRCAm||1.66|0.63|0.9403
71017222|NCT03692078|141541648|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.177||||0.8765|TWO_SIDED|95.0|-0.609|0.254|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||0.254|-0.609|0.8765
71017223|NCT03692078|141541648|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.101||||0.9954|TWO_SIDED|95.0|-0.488|0.287|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.287|-0.488|0.9954
71017224|NCT03692078|141541648|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.181||||0.8665|TWO_SIDED|95.0|-0.613|0.252|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.252|-0.613|0.8665
71017225|NCT03692078|141541648|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.389||||0.1165|TWO_SIDED|95.0|-0.829|0.052|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||0.052|-0.829|0.1165
71017226|NCT03692078|141541648|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.326||||0.3896|TWO_SIDED|95.0|-0.821|0.168|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||0.168|-0.821|0.3896
71017227|NCT03692078|141541648|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.504||||0.0122|TWO_SIDED|95.0|-0.934|-0.074|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.074|-0.934|0.0122
71017228|NCT03692078|141541648|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.32||||0.3938|TWO_SIDED|95.0|-0.807|0.167|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||0.167|-0.807|0.3938
71017229|NCT03692078|141541648|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.176||||0.8501|TWO_SIDED|95.0|-0.237|0.589|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||0.589|-0.237|0.8501
71105289|NCT03330847|141717888|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9282|TWO_SIDED|90.0|0.52|1.88|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib monotherapy.|Patient Population BRCAm||1.88|0.52|0.9282
70931528|NCT01371994|141363522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0592|||||||Cochran-Mantel-Haenszel|Cochran-Mental-Haenszel test stratified by (pooled) center||Comparison at Week 12||||0.0592
70931529|NCT01371994|141363522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|||||||Cochran-Mantel-Haenszel|Cochran-Mental-Haenszel test stratified by (pooled) center||Comparison of end of treatment analysis||||0.0390
70931530|NCT01371994|141363524|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.3604|TWO_SIDED|95.0|-0.14|0.38|||ANCOVA|Based on an analysis of variance model including treatment and (pooled) center as fixed factors.||Comparison at Week 4||0.38|-0.14|0.3604
70931531|NCT01371994|141363524|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.2|STANDARD_ERROR_OF_MEAN|0.14||0.0761|TWO_SIDED|95.0|-0.03|0.52|||ANCOVA|Based on an analysis of variance model including treatment and (pooled) center as fixed factors.||Comparison at Week 8||0.52|-0.03|0.0761
70931532|NCT01371994|141363524|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.4|STANDARD_ERROR_OF_MEAN|0.15||0.0149|TWO_SIDED|95.0|0.07|0.64|||ANCOVA|Based on an analysis of variance model including treatment and (pooled) center as fixed factors.||Comparison at Week 12||0.64|0.07|0.0149
70931533|NCT01371994|141363524|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0325|TWO_SIDED|95.0|0.02|0.52|||ANCOVA|Based on an analysis of variance model including treatment and (pooled) center as fixed factors.||Comparison of end of treatment analysis||0.52|0.02|0.0325
70931534|NCT01371994|141363526|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.3|STANDARD_ERROR_OF_MEAN|0.46||0.5186|TWO_SIDED|95.0|-0.6|1.19|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||1.19|-0.60|0.5186
71017230|NCT03692078|141541648|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.031||||1|TWO_SIDED|95.0|-0.435|0.496|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||0.496|-0.435|1.0000
71017231|NCT03692078|141541648|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.299||||0.2928|TWO_SIDED|95.0|-0.117|0.715|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||0.715|-0.117|0.2928
71017232|NCT03692078|141541648|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.027||||1|TWO_SIDED|95.0|-0.439|0.493|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||0.493|-0.439|1.0000
70931535|NCT01371994|141363526|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.3|STANDARD_ERROR_OF_MEAN|0.43||0.4521|TWO_SIDED|95.0|-0.52|1.17|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||1.17|-0.52|0.4521
70931536|NCT01371994|141363528|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1493|TWO_SIDED|95.0|-0.07|0.47|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||0.47|-0.07|0.1493
70851067|NCT01584440|141190383|SUPERIORITY||ANCOVA Least Squares Mean Difference|-3.94|||||TWO_SIDED||||||||Day 70|||||
71017233|NCT03692078|141541648|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.011||||1|TWO_SIDED|95.0|-0.453|0.475|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.475|-0.453|1.0000
71017234|NCT03692078|141541648|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.118||||0.9966|TWO_SIDED|95.0|-0.64|0.403|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.403|-0.640|0.9966
70931537|NCT01371994|141363528|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1499|TWO_SIDED|95.0|-0.07|0.44|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||0.44|-0.07|0.1499
70931538|NCT01371994|141363530|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.5|STANDARD_ERROR_OF_MEAN|0.35||0.1279|TWO_SIDED|95.0|-0.16|1.23|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||1.23|-0.16|0.1279
70931539|NCT01371994|141363530|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.6|STANDARD_ERROR_OF_MEAN|0.34||0.1038|TWO_SIDED|95.0|-0.11|1.23|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||1.23|-0.11|0.1038
70931540|NCT01371994|141363532|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.98||0.8876|TWO_SIDED|95.0|-4.19|3.63|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||3.63|-4.19|0.8876
70931541|NCT01371994|141363532|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-2.4|STANDARD_ERROR_OF_MEAN|2.86||0.395|TWO_SIDED|95.0|-8.1|3.21|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||3.21|-8.10|0.3950
70931542|NCT01371994|141363534|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|2.0|STANDARD_ERROR_OF_MEAN|2.43||0.4126|TWO_SIDED|95.0|-2.82|6.81|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||6.81|-2.82|0.4126
70931543|NCT01371994|141363534|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|1.0|STANDARD_ERROR_OF_MEAN|2.47||0.6959|TWO_SIDED|95.0|-3.92|5.85|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||5.85|-3.92|0.6959
70931544|NCT01371994|141363536|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|3.3|STANDARD_ERROR_OF_MEAN|2.81||0.2402|TWO_SIDED|95.0|-2.26|8.91|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||8.91|-2.26|0.2402
70851068|NCT01584440|141190384|SUPERIORITY||OLS Z-statistic|-2.46||||0.014|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.014
70931545|NCT01371994|141363536|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|1.1|STANDARD_ERROR_OF_MEAN|2.83||0.698|TWO_SIDED|95.0|-4.5|6.7|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||6.70|-4.50|0.6980
70931546|NCT01371994|141363538|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|2.0|STANDARD_ERROR_OF_MEAN|2.46||0.4067|TWO_SIDED|95.0|-2.8|6.89|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||6.89|-2.80|0.4067
70931547|NCT01371994|141363538|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.4|STANDARD_ERROR_OF_MEAN|2.36||0.8507|TWO_SIDED|95.0|-4.21|5.1|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||5.10|-4.21|0.8507
70931548|NCT01371994|141363539|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27|||||||Log Rank|Based on a Log-rank test stratified by (pooled) center.||||||0.2700
70931549|NCT03280030|141363541|OTHER|Success criteria is considered based on point estimated Hazard ratio|Hazard Ratio, log|1.326|||||TWO_SIDED|95.0|0.624|2.818||||||||2.818|0.624|
70931550|NCT00747565|141363555|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||t-test, 2 sided|||ETDRS line scores used for statistical comparisons with mean Snellen values reported above.||||<0.0001
70931551|NCT05120856|141363556|SUPERIORITY||Slope|-1.106369|STANDARD_ERROR_OF_MEAN|0.4985347||0.026|TWO_SIDED|95.0|-2.083479|-0.129259||This is the p value for the overall group x time interaction.|Mixed Models Analysis|The model compared groups' change across all time points Time was coded as a continuous variable (i.e., 0, 4, 8, and 16).|This is the effect estimate for the group x time interaction.|||-0.129259|-2.083479|.026
70931552|NCT05120856|141363556|SUPERIORITY||Mean Difference (Final Values)|5.025|STANDARD_ERROR_OF_MEAN|8.737||0.565|TWO_SIDED|95.0|-12.098|22.149|||t-test, 2 sided|||planned between-group post-hoc comparison at 4-week follow-up||22.149|-12.098|.565
70931553|NCT05120856|141363556|SUPERIORITY||Mean Difference (Final Values)|-3.349|STANDARD_ERROR_OF_MEAN|8.891||0.706|TWO_SIDED|95.0|-20.774|14.077|||t-test, 2 sided|||Planned post-hoc comparison between groups at 8-week follow-up||14.077|-20.774|.706
70931554|NCT05120856|141363556|SUPERIORITY||Mean Difference (Final Values)|-6.921|STANDARD_ERROR_OF_MEAN|9.394||0.461|TWO_SIDED|95.0|-25.332|11.491|||t-test, 2 sided|||Planned post-hoc comparison between groups at 16-week follow-up||11.491|-25.332|.461
70931555|NCT05120856|141363556|SUPERIORITY||Slope|-1.0838|STANDARD_ERROR_OF_MEAN|0.4798||0.0252|TWO_SIDED|95.0|-2.0229626|-0.1419329||This is the p value for the group x time interaction|Mixed Models Analysis|||In an additional sensitivity analysis, past-week alcohol use data was excluded if a participant reported having been in residential/inpatient treatment where they could not access alcohol for the whole of the past week at the time of follow-up. This resulted in data for one participant in the ApBM group being excluded at week 8, and 1 control being excluded at week 16.||-0.1419329|-2.0229626|.0252
70931556|NCT05120856|141363557|SUPERIORITY||Slope|-0.016|STANDARD_ERROR_OF_MEAN|0.033||0.633|TWO_SIDED|95.0|-0.08|0.05||This is the p value for the time x group interaction.|Mixed Models Analysis|||This is the test for the overall CEQ-F scores||0.05|-0.08|.633
70931557|NCT05120856|141363557|SUPERIORITY||Slope|-0.033|STANDARD_ERROR_OF_MEAN|0.041||0.411|TWO_SIDED|95.0|-0.11|0.05||This is for the time x group interaction for the intensity subscale|Mixed Models Analysis|||This is for the test of the CEQ-F Intensity subscale score||0.05|-0.11|.411
70931558|NCT05120856|141363557|SUPERIORITY||Slope|-0.009|STANDARD_ERROR_OF_MEAN|0.036||0.808|TWO_SIDED|95.0|-0.08|0.06||p value for the time x group interaction for Imagery subscale|Mixed Models Analysis|||Analysis of CEQ-F Imagery subscale score||0.06|-0.08|.808
70931559|NCT05120856|141363557|SUPERIORITY||Slope|-0.006|STANDARD_ERROR_OF_MEAN|0.041||0.886|TWO_SIDED|95.0|-0.09|0.08||This is the p value for the time x group interaction for the Intrusiveness subscale score|Mixed Models Analysis|||This is for the analysis of the CEQ-F Intrusiveness subscale score||0.08|-0.09|.886
70931560|NCT05120856|141363558|SUPERIORITY||Slope|0.083|STANDARD_ERROR_OF_MEAN|0.066||0.207|TWO_SIDED|95.0|-0.046|0.212||This is the p value for the time x group interaction|Mixed Models Analysis|||||0.212|-0.046|.207
70931561|NCT05120856|141363559|SUPERIORITY||Slope|-0.026|STANDARD_ERROR_OF_MEAN|0.166||0.876|TWO_SIDED|95.0|-0.352|0.3||This is the p value for the group x time interaction.|Mixed Models Analysis|||||0.300|-0.352|.876
70931562|NCT05120856|141363560|SUPERIORITY||Slope|-0.069|STANDARD_ERROR_OF_MEAN|0.037||0.064|TWO_SIDED|95.0|-0.142|0.004||This is the p value for the group x time interaction|Mixed Models Analysis|||||0.004|-0.142|.064
70931563|NCT05120856|141363561|SUPERIORITY||Slope|-0.059|STANDARD_ERROR_OF_MEAN|0.143||0.679|TWO_SIDED|95.0|-0.338|0.22||This is the p value for the group x time interaction|Mixed Models Analysis|||||0.220|-0.338|.679
70931564|NCT05120856|141363563|SUPERIORITY||Slope|0.072|STANDARD_ERROR_OF_MEAN|0.086||0.403|TWO_SIDED|95.0|-0.097|0.24||This is the p value for the group x time interaction|Mixed Models Analysis|||||0.240|-0.097|.403
70931565|NCT05120856|141363564|SUPERIORITY||Slope|-0.052|STANDARD_ERROR_OF_MEAN|0.037||0.161|TWO_SIDED|95.0|-0.126|0.021||This is the p value for the group x time interaction|Mixed Models Analysis|||Linear mixed-effects model analysis of psychological well-being ratings.||0.021|-0.126|.161
70931566|NCT05120856|141363564|SUPERIORITY||Slope|-0.029|STANDARD_ERROR_OF_MEAN|0.036||0.425|TWO_SIDED|95.0|-0.099|0.042||This is the p value for the group x time interaction|Mixed Models Analysis|||Linear mixed-effects model analysis of physical well-being ratings||0.042|-0.099|.425
71105290|NCT03330847|141717888|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.1274|TWO_SIDED|90.0|0.28|1.03|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + ceralasertib.|Patient Population Non BRCAm HRRm||1.03|0.28|0.1274
70931567|NCT05120856|141363564|SUPERIORITY||Slope|-0.039|STANDARD_ERROR_OF_MEAN|0.034||0.247|TWO_SIDED|95.0|-0.106|0.027||This is the p value for the group x time interaction|Mixed Models Analysis|||Linear mixed-effects model analysis of quality of life ratings||0.027|-0.106|.247
70931568|NCT05120856|141363565|SUPERIORITY||Slope|3.645|STANDARD_ERROR_OF_MEAN|10.369||0.725|TWO_SIDED|95.0|-16.68|23.97||This is the p value for the group x time interaction|Mixed Models Analysis|||||23.97|-16.68|.725
70931569|NCT00227266|141363583|SUPERIORITY_OR_OTHER_LEGACY||Spearman's correlation|0.93|||<|0.001|||||||Spearman's correlation|||MHFMS-Extend was not normally distributed at p=0.048. Test-retest reliability of MHFMS-Extend measurements from the first (S1) to the second (S2) screening visit was analyzed using Spearman's correlation.||||<0.001
70931570|NCT03455985|141363721|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.4||0.09|TWO_SIDED||||||Regression, Linear|||||||0.09
70931571|NCT03455985|141363722|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.2|TWO_SIDED||||||Regression, Linear|||||||0.20
70931572|NCT03455985|141363723|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
70931573|NCT03455985|141363724|SUPERIORITY||Mean Difference (Final Values)|-26.5|STANDARD_ERROR_OF_MEAN|30.3||0.39|TWO_SIDED||||||Regression, Linear|||||||0.39
70931574|NCT02347332|141363756|SUPERIORITY|||||||0.8329|TWO_SIDED|95.0||||Threshold significance value p\<0.05|Log Rank|||||||0.8329
70931575|NCT02347332|141363757|SUPERIORITY|||||||0.3576|TWO_SIDED|95.0||||Threshold significance value p\<0.05|Log Rank|||||||0.3576
70931576|NCT02347332|141363758|SUPERIORITY|||||||0.467|TWO_SIDED|95.0||||Threshold significance value p\<0.05|Log Rank|||||||0.467
70931577|NCT02347332|141363759|SUPERIORITY|||||||0.243|TWO_SIDED|95.0||||Threshold significance value p\<0.05|Log Rank|||||||0.243
70931578|NCT02347332|141363760|SUPERIORITY|||||||0.6289|TWO_SIDED|95.0||||Threshold significance value p\<0.05|Log Rank|||||||0.6289
70931579|NCT01970007|141363761|OTHER||Freedom from MAE rate (%)|96.7|||<|0.0001|TWO_SIDED|95.0|93.5|98.6|||One-sided Exact binomial test||One-sided Exact binomial test|||98.6|93.5|<0.0001
70931580|NCT01970007|141363762|OTHER||12-month quantitative patency rate (%)|89.9|||<|0.0001|TWO_SIDED|95.0|85.1|93.4|||Binomial test for one proportion||Binomial test for one proportion|||93.4|85.1|<0.0001
70851069|NCT01584440|141190384|SUPERIORITY||ANCOVA Least Squares Mean Difference|-2.65|||||TWO_SIDED||||||||Day 36|||||
70851070|NCT01584440|141190384|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.01|||||TWO_SIDED||||||||||Day 70|||
71017235|NCT03692078|141541648|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.104||||0.9976|TWO_SIDED|95.0|-0.56|0.352|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.352|-0.560|0.9976
71017236|NCT03692078|141541648|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.112||||0.9976|TWO_SIDED|95.0|-0.628|0.404|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.404|-0.628|0.9976
71017237|NCT03692078|141541650|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|180.0|||<|0.0001|TWO_SIDED|95.0|164.9|195.2|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||195.2|164.9|<.0001
71017238|NCT03692078|141541650|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|181.1|||<|0.0001|TWO_SIDED|95.0|165.9|196.2|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||196.2|165.9|<.0001
71017239|NCT03692078|141541650|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|132.3|||<|0.0001|TWO_SIDED|95.0|117.2|147.5|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||147.5|117.2|<.0001
71017240|NCT03692078|141541650|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|137.3|||<|0.0001|TWO_SIDED|95.0|122.1|152.5|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||152.5|122.1|<.0001
71050740|NCT03276221|141608087|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.12||0.312|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the multitasking test module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making an error for the abstinence group above and beyond the monitoring group (positive values indicate higher error commission for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.312
70931581|NCT01970007|141363763|OTHER||Change from Baseline Mean|-3.0|||<|0.0001|TWO_SIDED|95.0|-3.5|-2.6||P-value is adjusted for multiplicity|paired t-test|A paired t-test with p-values adjusted for multiple comparisons using the Holm's procedure to control for a family-wise Type I error rate of 0.05.||||-2.6|-3.5|<0.0001
70931582|NCT01970007|141363764|OTHER||Change from Baseline Mean|-4.2|||<|0.0001|TWO_SIDED|95.0|-4.7|-3.7||p-value is adjusted for multiplicity.|pair t-test|A paired t-test with p-values adjusted for multiple comparisons using the Holm's procedure to control for a family-wise Type I error rate of 0.05||||-3.7|-4.7|<0.0001
70931583|NCT00112359|141363776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.98||||0.0006|TWO_SIDED|95.0|3.5|12.47||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, baseline CFQ-R RSS, and disease severity (FEV1 \>50% or \<=50% pred.). Treatment differences: AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in CFQ-R RSS score at Day 14.||12.47|3.50|0.0006
70931584|NCT00112359|141363777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.33||||0.0154|TWO_SIDED|95.0|1.22|11.43||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, baseline CFQ-R RSS, and disease severity (FEV1 \>50% or \<=50% pred.). Treatment differences: AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in CFQ-R RSS score at Day 42.||11.43|1.22|0.0154
71017241|NCT03692078|141541650|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|136.8|||<|0.0001|TWO_SIDED|95.0|122.0|151.7|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||151.7|122.0|<.0001
71017242|NCT03692078|141541650|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|150.8|||<|0.0001|TWO_SIDED|95.0|136.0|165.7|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||165.7|136.0|<.0001
70851071|NCT01584440|141190385|SUPERIORITY||OLS Z-statistic|-2.57||||0.01|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.010
71017243|NCT03692078|141541650|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|43.2|||<|0.0001|TWO_SIDED|95.0|25.1|61.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||61.4|25.1|<.0001
71017244|NCT03692078|141541650|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|61.7|||<|0.0001|TWO_SIDED|95.0|43.2|80.1|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||80.1|43.2|<.0001
71017245|NCT03692078|141541650|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|36.9|||<|0.0001|TWO_SIDED|95.0|18.6|55.1|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||55.1|18.6|<.0001
71017246|NCT03692078|141541650|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|35.5||||0.0002|TWO_SIDED|95.0|16.7|54.3|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||54.3|16.7|0.0002
70931585|NCT00112359|141363780|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|10.294|||<|0.0001|TWO_SIDED|95.0|6.288|14.299||Analysis based on two-sided test with an 0.025 a priori threshold for statistical significance as part of the methods used to control the family-wise type 1 error.|ANCOVA|ANCOVA model included treatment, disease severity (FEV1 \>50% or \<=50% pred.), and Day 0 FEV1. Treatment differences: AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in percent change in FEV1 at Day 28.||14.299|6.288|<0.0001
71077903|NCT02913105|141664398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.86||||0.0179|TWO_SIDED|90.0|0.77|0.95|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 7||0.95|0.77|0.0179
70931586|NCT00112359|141363781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.453|||<|0.0001|TWO_SIDED|95.0|-2.115|-0.791||Analysis based on 2-sided test with an 0.025 a priori threshold for statistical significance as part of methods used to control family-wise type 1 error.|ANCOVA|ANCOVA model included terms for treatment and disease severity (FEV1 \>50% or \<=50% pred.). Treatment differences calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change in log10 PA CFUs in sputum at Day 28.||-0.791|-2.115|< 0.0001
70931587|NCT00112359|141363782|SUPERIORITY_OR_OTHER|||||||0.2364||95.0||||Analysis based on 2-sided test with an 0.025 a priori threshold for statistical significance as part of methods used to control family-wise type 1 error.|Fisher Exact|Comparison by treatment for proportion of subjects using additional (nonprotocol-specified) antipseudomonal antibiotics at least once during study.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in number of participants using additional (nonprotocol-specified) antipseudomonal antibiotics during study.||||0.2364
70931588|NCT00112359|141363783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.71||||0.0005|TWO_SIDED|95.0|4.31|15.11||"Primary endpoint analysis based on 2-sided test with an 0.05 a priori threshold for statistical significance.~A gate-keeping procedure to control family-wise Type 1 error was established a priori for primary and key secondary endpoints."|ANCOVA|ANCOVA model includes treatment, baseline CFQ-R RSS, and disease severity (FEV1 \>50% or \<=50% pred.). Treatment differences: AZLI-placebo.||"Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in CFQ-R RSS score at Day 28.~A sample size of 70 participants per treatment group provided approximately 77% power to detect an 8-point difference in CFQ-R RSS score between treatment groups, assuming a standard deviation (SD) of 20 and a Type I error rate of 0.05."||15.11|4.31|0.0005
70931589|NCT00112359|141363784|SUPERIORITY_OR_OTHER|||||||0.064||0.0||||No adjustments were made for multiple comparisons.|Fisher Exact|Comparison by treatment group for proportion of participants hospitalized at least once between Day 0 and Day 42 (or 14 days after last study dose).||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in number of participants hospitalized at least once during the study.||||0.0640
70931590|NCT01961609|141363786|SUPERIORITY_OR_OTHER||Percentage|65.3|||<|0.0001|TWO_SIDED|99.375|52.4|76.7|||two-sided binomial exact test||A Bonferroni adjustment adjusting for 8 analyses have been applied.|||76.7|52.4|<0.0001
70931591|NCT01988402|141363803|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.5
70931592|NCT03983434|141363815|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.62|||||||Kruskal-Wallis|||||||.62
70931593|NCT03983434|141363816|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.17|||||||Kruskal-Wallis|||||||0.17
70931594|NCT03983434|141363817|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.17|||||||Kruskal-Wallis|||||||0.17
70931595|NCT03983434|141363818|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.079|||||||Kruskal-Wallis|||||||0.079
70931596|NCT03983434|141363819|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.47|||||||Kruskal-Wallis|||||||0.47
70931597|NCT03983434|141363821|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.03|||||||Kruskal-Wallis|||||||0.03
70931598|NCT03983434|141363822|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.14|||||||Kruskal-Wallis|||||||0.14
70931599|NCT03983434|141363823|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.074|||||||Kruskal-Wallis|||||||0.074
70931600|NCT03983434|141363824|OTHER|||||||0.004|||||||Kruskal-Wallis|||||||0.004
70931601|NCT03983434|141363825|OTHER|||||||0.17|||||||Kruskal-Wallis|||||||0.17
70851072|NCT01584440|141190385|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.68|||||TWO_SIDED||||||||Day 36|||||
70931602|NCT03983434|141363826|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.98|||||||Kruskal-Wallis|||||||0.98
71077904|NCT02913105|141664398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.9||||0.1125|TWO_SIDED|90.0|0.8|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 14||1.00|0.80|0.1125
70931603|NCT01324310|141363869|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Geometric Mean|124.4|||||TWO_SIDED|90.0|110.2|140.5|||ANOVA||"Geometric means ratio (Romidepsin + Ketoconazole/Romidepsin) and 90% CI of the ratio of geometric means are from an ANOVA model with treatment as fixed effect and subject as random effect on the natural log transformed PK values."|||140.5|110.2|
70931604|NCT01324310|141363870|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean|123.7|||||TWO_SIDED|90.0|109.6|139.6|||ANOVA|||||139.6|109.6|
70931605|NCT01324310|141363871|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean|124.6|||||TWO_SIDED|90.0|109.0|142.4|||ANOVA|||||142.4|109.0|
70931606|NCT01324310|141363872|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean|109.5|||||TWO_SIDED|90.0|94.9|126.4|||ANOVA|||||126.4|94.9|
70931607|NCT01324310|141363873|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.7422|TWO_SIDED|90.0|-0.485|0.095|||Wilcoxon signed- rank|||"Note: The median, median difference (romidepsin + ketoconazole minus romidepsin) and 90% CI of the median difference are from Hodges-Lehmann Estimate. The P-value is from Wilcoxon signed-rank test."||0.095|-0.485|0.7422
70931608|NCT04027439|141363888|OTHER||Contrast Ratio|1.186|||<|0.0001|TWO_SIDED|95.0|1.138|1.235|||ANCOVA|||||1.235|1.138|<0.0001
70931609|NCT04027439|141363888|OTHER||Contrast Ratio|1.134|||<|0.0001|TWO_SIDED|95.0|1.088|1.181|||ANCOVA|||||1.181|1.088|<0.0001
70931610|NCT04027439|141363888|OTHER||Contrast Ratio|1.134|||<|0.0001|TWO_SIDED|95.0|1.089|1.181|||ANCOVA|||||1.181|1.089|<0.0001
70931611|NCT04027439|141363888|OTHER||Contrast Ratio|1.084||||0.0001|TWO_SIDED|95.0|1.041|1.128|||ANCOVA|||||1.128|1.041|0.0001
70851073|NCT01584440|141190385|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.2|||||TWO_SIDED||||||||Day 70|||||
70931612|NCT04027439|141363889|OTHER||Contrast Ratio|1.228||||0.0004|TWO_SIDED|95.0|1.105|1.365|||ANCOVA|||||1.365|1.105|0.0004
70931613|NCT04027439|141363889|OTHER||Contrast Ratio|1.228||||0.0004|TWO_SIDED|95.0|1.104|1.365|||ANCOVA|||||1.365|1.104|0.0004
70931614|NCT04027439|141363889|OTHER||Contrast Ratio|1.196||||0.0012|TWO_SIDED|95.0|1.08|1.326|||ANCOVA|||||1.326|1.080|0.0012
70931615|NCT04027439|141363889|OTHER||Contrast Ratio|1.121||||0.0348|TWO_SIDED|95.0|1.009|1.246|||ANCOVA|||||1.246|1.009|0.0348
70931616|NCT04027439|141363889|OTHER||Contrast Ratio|1.055||||0.3106|TWO_SIDED|95.0|0.949|1.172|||ANCOVA|||||1.172|0.949|0.3106
70931617|NCT04027439|141363890|OTHER||Contrast Ratio|1.154||||0.0208|TWO_SIDED|95.0|1.024|1.301|||ANCOVA|||||1.301|1.024|0.0208
70931618|NCT04027439|141363890|OTHER||Contrast Ratio|1.2||||0.0041|TWO_SIDED|95.0|1.064|1.353|||ANCOVA|||||1.353|1.064|0.0041
70931619|NCT04027439|141363890|OTHER||Contrast Ratio|1.167||||0.0108|TWO_SIDED|95.0|1.039|1.311|||ANCOVA|||||1.311|1.039|0.0108
70931620|NCT04027439|141363890|OTHER||Contrast Ratio|1.087||||0.1641|TWO_SIDED|95.0|0.965|1.225|||ANCOVA|||||1.225|0.965|0.1641
71017247|NCT03692078|141541650|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|38.8|||<|0.0001|TWO_SIDED|95.0|19.9|57.6|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||57.6|19.9|<.0001
71017248|NCT03692078|141541650|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|44.9|||<|0.0001|TWO_SIDED|95.0|26.0|63.8|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||63.8|26.0|<.0001
71017249|NCT03692078|141541650|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-47.7||||0.0002|TWO_SIDED|95.0|-78.0|-17.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-17.4|-78.0|0.0002
71017250|NCT03692078|141541650|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-43.8||||0.0009|TWO_SIDED|95.0|-74.1|-13.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-13.4|-74.1|0.0009
71017251|NCT03692078|141541650|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-43.2||||0.0009|TWO_SIDED|95.0|-73.2|-13.3|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-13.3|-73.2|0.0009
71017252|NCT03692078|141541650|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-30.2||||0.0466|TWO_SIDED|95.0|-60.2|-0.3|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.3|-60.2|0.0466
71017253|NCT03692078|141541650|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-136.8|||<|0.0001|TWO_SIDED|95.0|-170.4|-103.3|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-103.3|-170.4|<.0001
70931621|NCT04027439|141363891|OTHER||Contrast Ratio|1.229||||0.0005|TWO_SIDED|95.0|1.102|1.369|||ANCOVA|||||1.369|1.102|0.0005
70931622|NCT04027439|141363891|OTHER||Contrast Ratio|1.231||||0.0005|TWO_SIDED|95.0|1.104|1.372|||ANCOVA|||||1.372|1.104|0.0005
70931623|NCT04027439|141363891|OTHER||Contrast Ratio|1.188||||0.0022|TWO_SIDED|95.0|1.07|1.32|||ANCOVA|||||1.320|1.070|0.0022
70931624|NCT04027439|141363891|OTHER||Contrast Ratio|1.106||||0.0658|TWO_SIDED|95.0|0.993|1.233|||ANCOVA|||||1.233|0.993|0.0658
70931625|NCT04027439|141363899|OTHER||Contrast Ratio|1.183|||<|0.0001|TWO_SIDED|95.0|1.134|1.234|||ANCOVA|||||1.234|1.134|<0.0001
70931626|NCT04027439|141363899|OTHER||Contrast Ratio|1.14|||<|0.0001|TWO_SIDED|95.0|1.092|1.19|||ANCOVA|||||1.190|1.092|<0.0001
70931627|NCT04027439|141363899|OTHER||Contrast Ratio|1.131|||<|0.0001|TWO_SIDED|95.0|1.084|1.18|||ANCOVA|||||1.180|1.084|<0.0001
70931628|NCT04027439|141363899|OTHER||Contrast Ratio|1.08||||0.0004|TWO_SIDED|95.0|1.036|1.126|||ANCOVA|||||1.126|1.036|0.0004
70931629|NCT04027439|141363900|OTHER||Contrast Ratio|1.123|||<|0.0001|TWO_SIDED|95.0|1.078|1.169|||ANCOVA|||||1.169|1.078|<0.0001
71017254|NCT03692078|141541650|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-119.4|||<|0.0001|TWO_SIDED|95.0|-153.3|-85.5|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-85.5|-153.3|<.0001
71050741|NCT03276221|141608088|SUPERIORITY||Slope|1.92|STANDARD_ERROR_OF_MEAN|9.27||0.836|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the multitasking test module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the median response latency for the abstinence group above and beyond the monitoring group (positive values indicate higher slower responses for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.836
71050742|NCT03276221|141608089|SUPERIORITY||Slope|-0.5|STANDARD_ERROR_OF_MEAN|3.93||0.898|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the multitasking test module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the median incongruency cost for the abstinence group above and beyond the monitoring group (positive values indicate higher costs for incongruent trials for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.898
70931630|NCT04027439|141363900|OTHER||Contrast Ratio|1.078||||0.0004|TWO_SIDED|95.0|1.035|1.122|||ANCOVA|||||1.122|1.035|0.0004
71050743|NCT03276221|141608090|SUPERIORITY||Slope|16.54|STANDARD_ERROR_OF_MEAN|9.05||0.068|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the multitasking test module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the multitasking cost for the abstinence group above and beyond the monitoring group (positive values indicate higher costs for multitasking trials for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.068
71050744|NCT03276221|141608091|SUPERIORITY||Slope|0.15|STANDARD_ERROR_OF_MEAN|0.1||0.15|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the one touch stockings of Cambridge module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making a correct response for the abstinence group above and beyond the monitoring group (positive values indicate higher accuracy for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.150
71050745|NCT03276221|141608092|SUPERIORITY||Slope|179.11|STANDARD_ERROR_OF_MEAN|281.76||0.525|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the one touch stockings of Cambridge module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making an error for the abstinence group above and beyond the monitoring group (positive values indicate higher error commission for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.525
71105291|NCT03330847|141717888|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.2956|TWO_SIDED|90.0|0.23|1.26|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + adavosertib.|Patient Population Non BRCAm HRRm||1.26|0.23|0.2956
71105292|NCT03330847|141717888|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.2959|TWO_SIDED|90.0|0.5|1.14|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + ceralasertib.|Patient Population Non HRRm||1.14|0.50|0.2959
70931631|NCT04027439|141363900|OTHER||Contrast Ratio|1.081||||0.0002|TWO_SIDED|95.0|1.039|1.125|||ANCOVA|||||1.125|1.039|0.0002
70931632|NCT04027439|141363900|OTHER||Contrast Ratio|1.041||||0.0437|TWO_SIDED|95.0|1.001|1.083|||ANCOVA|||||1.083|1.001|0.0437
70931633|NCT04027439|141363901|OTHER||Contrast Ratio|1.087||||0.0006|TWO_SIDED|95.0|1.038|1.139|||ANCOVA|||||1.139|1.038|0.0006
71017255|NCT03692078|141541650|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-143.2|||<|0.0001|TWO_SIDED|95.0|-176.6|-109.7|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-109.7|-176.6|<.0001
71017256|NCT03692078|141541650|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-145.6|||<|0.0001|TWO_SIDED|95.0|-179.7|-111.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-111.4|-179.7|<.0001
71017257|NCT03692078|141541650|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|93.6|||<|0.0001|TWO_SIDED|95.0|60.0|127.2|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||127.2|60.0|<.0001
71017258|NCT03692078|141541650|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|92.4|||<|0.0001|TWO_SIDED|95.0|58.8|126.1|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||126.1|58.8|<.0001
71017259|NCT03692078|141541650|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|98.1|||<|0.0001|TWO_SIDED|95.0|64.6|131.5|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||131.5|64.6|<.0001
71017260|NCT03692078|141541650|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|106.0|||<|0.0001|TWO_SIDED|95.0|72.5|139.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||139.4|72.5|<.0001
71017261|NCT03692078|141541650|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|4.5||||1|TWO_SIDED|95.0|-32.0|40.9|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||40.9|-32.0|1.0000
71017262|NCT03692078|141541650|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|16.8||||0.7714|TWO_SIDED|95.0|-20.0|53.5|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||53.5|-20.0|0.7714
70851074|NCT01584440|141190386|SUPERIORITY||OLS Z-statistic|-3.08||||0.002|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.002
70851075|NCT01584440|141190386|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.56|||||TWO_SIDED||||||||Day 36|||||
70851076|NCT01584440|141190386|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.9|||||TWO_SIDED||||||||Day 70|||||
70931634|NCT04027439|141363901|OTHER||Contrast Ratio|1.083||||0.001|TWO_SIDED|95.0|1.034|1.135|||ANCOVA|||||1.135|1.034|0.0010
71017263|NCT03692078|141541650|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-1.9||||1|TWO_SIDED|95.0|-38.3|34.5|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||34.5|-38.3|1.0000
71050746|NCT03276221|141608093|SUPERIORITY||Slope|-10.86|STANDARD_ERROR_OF_MEAN|5.24||0.038|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the stop signal task module. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the inhibition latency for the abstinence group above and beyond the monitoring group (positive values indicate slower inhibition for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.038
71050747|NCT03276221|141608094|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.576|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the spatial working memory module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making an error for the abstinence group above and beyond the monitoring group (positive values indicate higher error commission for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.576
71050748|NCT03276221|141608095|SUPERIORITY||Slope|-0.15|STANDARD_ERROR_OF_MEAN|0.15||0.296|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the spatial working memory module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of trials with strategic responding for the abstinence group above and beyond the monitoring group (positive values indicate higher rates of strategic responding for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.296
71050749|NCT03276221|141608096|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.65|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the rapid visual information processing module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the discriminability measure for the abstinence group above and beyond the monitoring group (positive values indicate higher discriminability rates for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.650
71050750|NCT03276221|141608097|SUPERIORITY||Slope|-11.64|STANDARD_ERROR_OF_MEAN|9.55||0.223|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the rapid visual information processing module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the median response latency for the abstinence group above and beyond the monitoring group (positive values indicate slower responses for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.223
71050751|NCT02912650|141608098|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|30.08|||<|0.001|TWO_SIDED|95.0|24.14|36.02|||ANCOVA|||Treatment difference and 95 percent (%) confidence interval (CI) were based on LS Mean from analysis of covariance (ANCOVA) with treatment, gender, baseline categorical pain severity rating (PSR) as classification variables and baseline numerical PSR used as a continuous covariate.||36.02|24.14|<0.001
71050752|NCT02912650|141608098|SUPERIORITY_OR_OTHER||LS Mean Difference|5.66||||0.008|TWO_SIDED|95.0|1.51|9.8|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||9.80|1.51|0.008
71050753|NCT02912650|141608098|SUPERIORITY_OR_OTHER||LS Mean Difference|14.76|||<|0.001|TWO_SIDED|95.0|10.55|18.97|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||18.97|10.55|<0.001
71050754|NCT02912650|141608098|SUPERIORITY_OR_OTHER||LS Mean Difference|24.42|||<|0.001|TWO_SIDED|95.0|18.5|30.35|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||30.35|18.50|<0.001
71050755|NCT02912650|141608098|SUPERIORITY_OR_OTHER||LS Mean Difference|15.32|||<|0.001|TWO_SIDED|95.0|9.35|21.29|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||21.29|9.35|<0.001
71105293|NCT03330847|141717888|SUPERIORITY||Hazard Ratio (HR)|0.48||||0.0193|TWO_SIDED|90.0|0.28|0.8|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + adavosertib.|Patient Population Non HRRm||0.80|0.28|0.0193
71017264|NCT03692078|141541650|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-9.4||||0.9926|TWO_SIDED|95.0|-46.4|27.6|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||27.6|-46.4|0.9926
71017265|NCT03692078|141541652|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 1 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.872|||<|0.0001|TWO_SIDED|95.0|1.81|1.935|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 1 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||1.935|1.810|<.0001
71017266|NCT03692078|141541652|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 1 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.913|||<|0.0001|TWO_SIDED|95.0|1.851|1.976|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 1 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||1.976|1.851|<.0001
71017267|NCT03692078|141541652|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.467|||<|0.0001|TWO_SIDED|95.0|1.408|1.525|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||1.525|1.408|<.0001
71017268|NCT03692078|141541652|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.493|||<|0.0001|TWO_SIDED|95.0|1.434|1.551|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||1.551|1.434|<.0001
71017269|NCT03692078|141541652|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.55|||<|0.0001|TWO_SIDED|95.0|1.49|1.609|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||1.609|1.490|<.0001
71017270|NCT03692078|141541652|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.594|||<|0.0001|TWO_SIDED|95.0|1.533|1.654|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||1.654|1.533|<.0001
71017271|NCT03692078|141541652|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.557|||<|0.0001|TWO_SIDED|95.0|0.482|0.631|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||0.631|0.482|<.0001
71105294|NCT03330847|141717889|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.6147|TWO_SIDED|90.0|0.53|1.39|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + ceralasertib.|Patient Population BRCAm||1.39|0.53|0.6147
70931635|NCT04027439|141363901|OTHER||Contrast Ratio|1.096||||0.0002|TWO_SIDED|95.0|1.047|1.149|||ANCOVA|||||1.149|1.047|0.0002
70931636|NCT04027439|141363901|OTHER||Contrast Ratio|1.039||||0.0971|TWO_SIDED|95.0|0.993|1.088|||ANCOVA|||||1.088|0.993|0.0971
70931637|NCT04027439|141363902|OTHER||Contrast Ratio|1.145|||<|0.0001|TWO_SIDED|95.0|1.106|1.185|||ANCOVA|||||1.185|1.106|<0.0001
70931638|NCT04027439|141363902|OTHER||Contrast Ratio|1.148|||<|0.0001|TWO_SIDED|95.0|1.109|1.189|||ANCOVA|||||1.189|1.109|<0.0001
70931639|NCT04027439|141363902|OTHER||Contrast Ratio|1.099|||<|0.0001|TWO_SIDED|95.0|1.062|1.137|||ANCOVA|||||1.137|1.062|<0.0001
70931640|NCT04027439|141363902|OTHER||Contrast Ratio|1.088|||<|0.0001|TWO_SIDED|95.0|1.052|1.126|||ANCOVA|||||1.126|1.052|<0.0001
70931641|NCT04027439|141363903|OTHER||Contrast Ratio|1.15|||<|0.0001|TWO_SIDED|95.0|1.113|1.189|||ANCOVA|||||1.189|1.113|<0.0001
71017272|NCT03692078|141541652|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.589|||<|0.0001|TWO_SIDED|95.0|0.514|0.665|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||0.665|0.514|<.0001
71050756|NCT02912650|141608098|SUPERIORITY_OR_OTHER||LS Mean Difference|9.1|||<|0.001|TWO_SIDED|95.0|4.9|13.31|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||13.31|4.90|<0.001
70931642|NCT04027439|141363903|OTHER||Contrast Ratio|1.146|||<|0.0001|TWO_SIDED|95.0|1.109|1.185|||ANCOVA|||||1.185|1.109|<0.0001
70931643|NCT04027439|141363903|OTHER||Contrast Ratio|1.107|||<|0.0001|TWO_SIDED|95.0|1.071|1.144|||ANCOVA|||||1.144|1.071|<0.0001
70931644|NCT04027439|141363903|OTHER||Contrast Ratio|1.094|||<|0.0001|TWO_SIDED|95.0|1.059|1.13|||ANCOVA|||||1.130|1.059|<0.0001
70931645|NCT04027439|141363904|OTHER||Contrast Ratio|1.103|||<|0.0001|TWO_SIDED|95.0|1.066|1.141|||ANCOVA|||||1.141|1.066|<0.0001
70931646|NCT04027439|141363904|OTHER||Contrast Ratio|1.078|||<|0.0001|TWO_SIDED|95.0|1.042|1.116|||ANCOVA|||||1.116|1.042|<0.0001
70931647|NCT04027439|141363904|OTHER||Contrast Ratio|1.067||||0.0002|TWO_SIDED|95.0|1.032|1.104|||ANCOVA|||||1.104|1.032|0.0002
70931648|NCT04027439|141363904|OTHER||Contrast Ratio|1.048||||0.0066|TWO_SIDED|95.0|1.013|1.084|||ANCOVA|||||1.084|1.013|0.0066
70931649|NCT00979121|141363945|SUPERIORITY_OR_OTHER||difference in % of pts alive at 60 days|4.0||||0.21|TWO_SIDED|95.0|-2.3|10.2||The monitoring boundaries were designed to have a low probability of stopping for futility before 750 patients. The maximum sample size was 1000 patients. Efficacy stopping was based on mortality; futility stopping was based on mortality and VFDs.|Proc lifetest|Proc lifetest was used to calculate mortality mean and variance due to one subject lost to follow up who was censored.||Hospital mortality to day 60 was estimated using the Kaplan Meier estimate, with patients discharged home before day 60 considered alive at day 60. The analysis was stratified by co-enrolled treatment assignments for 81 patients also enrolled in a randomized clinical trial of two different nutritional strategies. A maximum of 1000 patients were to be enrolled, providing a 92% probability of rejecting the null hypothesis for the effect on mortality if a true difference in mortality was 9%.||10.2|-2.3|0.21
70931650|NCT00979121|141363946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.96||95.0|-1.6|1.5|||ANCOVA|||Ventilator, ICU free, and organ failure free days were analyzed by analysis of variance, utilizing treatment assignment where applicable.||1.5|-1.6|0.96
70931651|NCT02549352|141364012|SUPERIORITY||Ratio of clearance rates|7.83|||<|0.001|TWO_SIDED|95.0|2.58|23.71|||Mantel Haenszel||Mantel-Haenszel estimate (0.037% relative to vehicle), adjusted for pooled sites.|||23.71|2.58|<0.001
70931652|NCT02549352|141364013|SUPERIORITY||Ratio of clearance rates|5.91|||<|0.001|TWO_SIDED|95.0|3.32|10.51|||Mantel Haenszel||Mantel-Haenszel estimate (0.037% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||10.51|3.32|<0.001
70931653|NCT02549352|141364014|SUPERIORITY||Ratio of clearance rates|7.59|||<|0.001|TWO_SIDED|95.0|3.7|15.61|||Mantel Haenszel||Mantel-Haenszel estimate (0.037% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||15.61|3.70|<0.001
70931654|NCT02549352|141364015|SUPERIORITY||Week 8 AK count ratio|0.3|||<|0.001|TWO_SIDED|95.0|0.25|0.36||Negative binominal regression with treatment group and pooled site as factors and log baseline count as offset variable.|Mantel Haenszel||0.037% relative to vehicle.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||0.36|0.25|<0.001
70931655|NCT05048394|141364016|EQUIVALENCE|Equivalence is defined as a difference of 0.|||||<|0.001||||||Threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
70931656|NCT05048394|141364017|EQUIVALENCE|Equivalence is defined as a difference of 0.||||||0.14||||||Threshold for significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||||||0.14
70931657|NCT01617369|141364050|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||Paired t-test performed. Null hypothesis is that no difference in clearance 30 min and 4 hr after HS inhalation exists||||<.05
70931658|NCT01574716|141364070|SUPERIORITY||Hazard Ratio (HR)|1.08|||=|0.6562|TWO_SIDED|95.0|0.77|1.5|||Log Rank|Two-sided log-rank test|Based on Cox PH model|||1.50|0.77|= 0.6562
70931659|NCT01574716|141364071|SUPERIORITY||Hazard Ratio (HR)|1.13|||=|0.4469|TWO_SIDED|95.0|0.82|1.57|||Log Rank|Two-sided log-rank test|Based on Cox PH model|||1.57|0.82|=0.4469
70931660|NCT01574716|141364072|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.3153|TWO_SIDED|95.0|0.82|1.83|||Log Rank|Two-sided log-rank test|Based on Cox PH model|||1.83|0.82|0.3153
70851077|NCT01584440|141190387|SUPERIORITY||OLS Z-statistic|-2.66||||0.008|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.008
70931661|NCT01574716|141364073|SUPERIORITY||Difference|-0.6|||=|1|TWO_SIDED|95.0|-12.0|10.9|||Log Rank|Two-sided log-rank test|Based on Cox PH model|Difference equal to (=) (MORAb 8.0 mg/kg + Gemcitabine/Docetaxel) minus (Placebo + Gemcitabine/Docetaxel). Confidence interval based on a normal approximation to the binomial distribution.||10.9|-12.0|= 1.000
70851078|NCT01584440|141190387|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.43|||||TWO_SIDED||||||||Day 36|||||
71017273|NCT03692078|141541652|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.533|||<|0.0001|TWO_SIDED|95.0|0.461|0.605|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||0.605|0.461|<.0001
71017274|NCT03692078|141541652|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.588|||<|0.0001|TWO_SIDED|95.0|0.514|0.662|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||0.662|0.514|<.0001
71017275|NCT03692078|141541652|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 6 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.58|||<|0.0001|TWO_SIDED|95.0|0.508|0.652|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 6 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||0.652|0.508|<.0001
71050757|NCT02912650|141608099|SUPERIORITY_OR_OTHER||LS Mean Difference|9.26|||<|0.001|TWO_SIDED|95.0|6.59|11.94|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||11.94|6.59|<0.001
71050758|NCT02912650|141608099|SUPERIORITY_OR_OTHER||LS Mean Difference|1.84||||0.053|TWO_SIDED|95.0|-0.03|3.71|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.71|-0.03|0.053
71050759|NCT02912650|141608099|SUPERIORITY_OR_OTHER||LS Mean Difference|5.59|||<|0.001|TWO_SIDED|95.0|3.69|7.49|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||7.49|3.69|<0.001
71050760|NCT02912650|141608099|SUPERIORITY_OR_OTHER||LS Mean Difference|7.42|||<|0.001|TWO_SIDED|95.0|4.75|10.09|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||10.09|4.75|<0.001
70851079|NCT01584440|141190387|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.75|||||TWO_SIDED||||||||Day 70|||||
70851080|NCT01584440|141190388|SUPERIORITY||OLS Z-statistic|-1.96||||0.05|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.050
70851081|NCT01584440|141190388|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.62|||||TWO_SIDED||||||||Day 36|||||
70851082|NCT01584440|141190388|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.3|||||TWO_SIDED||||||||Day 70|||||
70851083|NCT01584440|141190389|SUPERIORITY||OLS Z-statistic|-2.33||||0.02|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.020
70851084|NCT01584440|141190389|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.57|||||TWO_SIDED||||||||Day 36|||||
70851085|NCT01584440|141190389|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.18|||||TWO_SIDED||||||||Day 70|||||
70851086|NCT01584440|141190390|SUPERIORITY||OLS Z-statistic|1.94||||0.053|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.053
70851087|NCT01584440|141190390|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.52|||||TWO_SIDED||||||||Day 36|||||
70851088|NCT01584440|141190390|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.84|||||TWO_SIDED||||||||Day 70|||||
70851089|NCT01584440|141190391|SUPERIORITY||OLS Z-statistic|-0.72||||0.469|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population|Caregiver|||||0.469
70851090|NCT01584440|141190391|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.28|||||TWO_SIDED||||||||Caregiver: Day 36|||||
70851091|NCT01584440|141190391|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.06|||||TWO_SIDED||||||||Caregiver: Day 70|||||
70851092|NCT01584440|141190391|SUPERIORITY||OLS Z-statistic|1.41||||0.159|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population|Participant|||||0.159
70851093|NCT01584440|141190391|SUPERIORITY||ANCOVA Least Squares Mean Difference|1.09|||||TWO_SIDED||||||||Participant: Day 36|||||
70851094|NCT01584440|141190391|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.7|||||TWO_SIDED||||||||Participant: Day 70|||||
70851095|NCT01584440|141190392|SUPERIORITY||OLS Z-statistic|-1.4||||0.163|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.163
70931662|NCT00692913|141364079|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.2|||<|0.001||95.0|0.12|0.35|||Regression, Logistic|The logistic regression model was adjusted by baseline 25-hydroxyvitamin D (25(OH)D) level stratum, age, and region.||||0.35|0.12|<0.001
70931663|NCT00692913|141364080|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares means|-9.7|||<|0.001||95.0|-14.49|-4.93|||Longitudinal Data Analysis Model|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.||||-4.93|-14.49|<0.001
70931664|NCT00692913|141364081|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares mean|-7.07|||<|0.001||95.0|-10.95|-3.2|||Longitudinal Data Analysis Model|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.||||-3.20|-10.95|<0.001
70931665|NCT00692913|141364082|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.21|||<|0.001||95.0|0.13|0.35|||Regression, Logistic|The logistic regression model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.||||0.35|0.13|<0.001
70931666|NCT00692913|141364083|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.01||||0.047||95.0|0.01|2.0|||Traditional Longitudinal data analysis|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.|FOSAVANCE minus Referred-Care. Analysis was for Lumbar Spine.|||2.00|0.01|0.047
70931667|NCT00692913|141364083|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.82||||0.035||95.0|0.06|1.58|||Traditional Longitudinal data analysis|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.|FOSAVANCE minus Referred-Care. Analysis was for Total Hip.|||1.58|0.06|0.035
71017276|NCT03692078|141541652|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 6 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.58|||<|0.0001|TWO_SIDED|95.0|0.507|0.653|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 6 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||0.653|0.507|<.0001
71017277|NCT03692078|141541652|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.406|||<|0.0001|TWO_SIDED|95.0|-0.526|-0.285|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.285|-0.526|<.0001
71017278|NCT03692078|141541652|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.421|||<|0.0001|TWO_SIDED|95.0|-0.541|-0.3|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.300|-0.541|<.0001
71017279|NCT03692078|141541652|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.323|||<|0.0001|TWO_SIDED|95.0|-0.444|-0.201|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.201|-0.444|<.0001
71017280|NCT03692078|141541652|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.32|||<|0.0001|TWO_SIDED|95.0|-0.442|-0.198|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.198|-0.442|<.0001
70931668|NCT00692913|141364084|SUPERIORITY_OR_OTHER_LEGACY||Difference of falls (falls/patient-year)|0.03|STANDARD_ERROR_OF_MEAN|0.08||0.675||95.0|-0.12|0.19|||Zero-Inflated Poisson Regression|Adjusted by the terms for treatment, baseline 25(OH) D level stratum, age, and region and offset variable of log (total patient-years in the study).||||0.19|-0.12|0.675
70931669|NCT00692913|141364085|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-8.35||||0.001||95.0|-13.19|-3.54|||Longitudinal Data Analysis Model|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.||||-3.54|-13.19|0.001
70931670|NCT00692913|141364086|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-8.07|||<|0.001||95.0|-11.94|-4.21|||Longitudinal Data Analysis Model|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.||||-4.21|-11.94|<0.001
70931671|NCT03801148|141364087|EQUIVALENCE|Natural log (ln)-transformed-Cmax, was analyzed using an analysis of variance (ANOVA) model to assess the relative bioavailability of dexlansoprazole 30 mg capsule manufactured at TOB compared with dexlansoprazole 30 mg capsule manufactured at TPC. Geometric least square mean (LSM) ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed Cmax.|Geometric LSM ratio|0.98|||||TWO_SIDED|90.0|0.9171|1.0473||||||||1.0473|0.9171|
70931672|NCT03801148|141364087|EQUIVALENCE|ln-transformed-Cmax, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 60 mg capsule manufactured at TOB compared with dexlansoprazole 60 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed Cmax.|Geometric LSM ratio|1.0737|||||TWO_SIDED|90.0|1.0025|1.1501||||||||1.1501|1.0025|
70931673|NCT03801148|141364088|EQUIVALENCE|ln-transformed- AUClast, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 30 mg capsule manufactured at TOB compared with dexlansoprazole 30 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUClast.|Geometric LSM ratio|1.0455|||||TWO_SIDED|90.0|1.007|1.0855||||||||1.0855|1.0070|
71017281|NCT03692078|141541652|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.315|||<|0.0001|TWO_SIDED|95.0|-1.453|-1.178|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.178|-1.453|<.0001
71017282|NCT03692078|141541652|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.324|||<|0.0001|TWO_SIDED|95.0|-1.463|-1.186|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.186|-1.463|<.0001
71017283|NCT03692078|141541652|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.339|||<|0.0001|TWO_SIDED|95.0|-1.473|-1.205|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.205|-1.473|<.0001
71017284|NCT03692078|141541652|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.325|||<|0.0001|TWO_SIDED|95.0|-1.461|-1.19|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.190|-1.461|<.0001
71017285|NCT03692078|141541652|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.887|||<|0.0001|TWO_SIDED|95.0|0.757|1.016|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.016|0.757|<.0001
71050761|NCT02912650|141608099|SUPERIORITY_OR_OTHER||LS Mean Difference|3.67||||0.008|TWO_SIDED|95.0|0.98|6.36|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||6.36|0.98|0.008
71050762|NCT02912650|141608099|SUPERIORITY_OR_OTHER||LS Mean Difference|3.75|||<|0.001|TWO_SIDED|95.0|1.85|5.64|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||5.64|1.85|<0.001
71050763|NCT02912650|141608100|SUPERIORITY_OR_OTHER||LS Mean Difference|13.05|||<|0.001|TWO_SIDED|95.0|10.39|15.71|||ANOVA|||0-8 hours: Treatment difference and 95% CI were based on LS Mean from analysis of variance (ANOVA) with treatment, gender and baseline categorical PSR.||15.71|10.39|<0.001
71050764|NCT02912650|141608100|SUPERIORITY_OR_OTHER||LS Mean Difference|3.01||||0.002|TWO_SIDED|95.0|1.15|4.86|||ANOVA|||0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.86|1.15|0.002
71050765|NCT02912650|141608100|SUPERIORITY_OR_OTHER||LS Mean Difference|6.94|||<|0.001|TWO_SIDED|95.0|5.06|8.83|||ANOVA|||0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||8.83|5.06|<0.001
71050766|NCT02912650|141608100|SUPERIORITY_OR_OTHER||LS Mean Difference|10.05|||<|0.001|TWO_SIDED|95.0|7.39|12.7|||ANOVA|||0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||12.70|7.39|<0.001
71050767|NCT02912650|141608100|SUPERIORITY_OR_OTHER||LS Mean Difference|6.11|||<|0.001|TWO_SIDED|95.0|3.44|8.78|||ANOVA|||0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||8.78|3.44|<0.001
71050768|NCT02912650|141608100|SUPERIORITY_OR_OTHER||LS Mean Difference|3.94|||<|0.001|TWO_SIDED|95.0|2.06|5.81|||ANOVA|||0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.81|2.06|<0.001
71050769|NCT02912650|141608100|SUPERIORITY_OR_OTHER||LS Mean Difference|3.84|||<|0.001|TWO_SIDED|95.0|2.63|5.05|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.05|2.63|<0.001
71017286|NCT03692078|141541652|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.912|||<|0.0001|TWO_SIDED|95.0|0.782|1.043|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.043|0.782|<.0001
70851096|NCT01584440|141190392|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.07|||||TWO_SIDED||||||||Day 36|||||
71017287|NCT03692078|141541652|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.97|||<|0.0001|TWO_SIDED|95.0|0.839|1.1|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.100|0.839|<.0001
71017288|NCT03692078|141541652|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|1.013|||<|0.0001|TWO_SIDED|95.0|0.882|1.145|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.145|0.882|<.0001
71017289|NCT03692078|141541652|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.023||||0.9999|TWO_SIDED|95.0|-0.168|0.122|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.122|-0.168|0.9999
71017290|NCT03692078|141541652|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.009||||1|TWO_SIDED|95.0|-0.138|0.155|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.155|-0.138|1.0000
71017291|NCT03692078|141541652|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.047||||0.9577|TWO_SIDED|95.0|-0.189|0.095|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.095|-0.189|0.9577
71017292|NCT03692078|141541652|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.008||||1|TWO_SIDED|95.0|-0.136|0.152|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.152|-0.136|1.0000
71017293|NCT01005680|141541660|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.822|TWO_SIDED|95.0|0.77|1.39||HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex, and basis for initial pathological diagnosis.|Cox Proportional Hazard|||||1.39|0.77|0.822
71017294|NCT01005680|141541661|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.64|TWO_SIDED|95.0|0.82|1.37||HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex and basis for initial pathological diagnosis.|Cox Proportional Hazard|||||1.37|0.82|0.640
71017295|NCT01005680|141541662|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.928|TWO_SIDED|95.0|0.78|1.32||HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex and biases for initial pathological diagnosis.|Cox Proportional Hazard|||||1.32|0.78|0.928
71017296|NCT01005680|141541663|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.887|TWO_SIDED|95.0|0.51|1.79||HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex and basis for initial pathological diagnosis.|Cox Proportional Hazard|||||1.79|0.51|0.887
71017297|NCT01005680|141541664|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.861|TWO_SIDED|95.0|0.67|1.61||HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex and basis for initial pathological diagnosis.|Cox Proportional Hazard|||||1.61|0.67|0.861
71017298|NCT01005680|141541665|SUPERIORITY_OR_OTHER|||||||0.451||95.0|||||two-sided Z test|||||||0.451
70851097|NCT01584440|141190392|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.39|||||TWO_SIDED||||||||Day 70|||||
71017299|NCT01005680|141541667|SUPERIORITY_OR_OTHER|||||||0.627||95.0|||||two-sided Z test|||||||0.627
71017300|NCT01339858|141541689|SUPERIORITY|||||||0.32|||||||ANOVA|||||||0.32
71017301|NCT01965431|141541734|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is the maximum acceptable extent of statistical and clinical noninferiority of an experimental treatment. Non-inferiority margin for this trial is 10ms.|Mean Difference (Net)|7.9|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|90.0|5.37|10.43|||||Maximum mean difference to placebo is estimated. Adjusted means are based on a mixed model for repeated measures with 'global' \& 'period-global baseline' covariates. Toeplitz covariance model used for modelling the random and repeated effect.|||10.43|5.37|
71017302|NCT01965431|141541735|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.7|STANDARD_ERROR_OF_MEAN|2.02|||TWO_SIDED|90.0|9.32|16.08|||||Maximum mean difference to placebo is estimated. Adjusted means are based on a mixed model for repeated measures with 'global' \& 'period-global baseline' covariates. Toeplitz covariance model used for modelling the random and repeated effect.|No formal hypothesis testing was done.||16.08|9.32|
71017303|NCT01965431|141541736|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|90.0|-1.38|1.73|||||Maximum mean difference to placebo is estimated. Adjusted means are based on a mixed model for repeated measures with 'global' \& 'period-global baseline' covariates. Toeplitz covariance model used for modelling the random and repeated effect.|No formal hypothesis testing was done.||1.73|-1.38|
71017304|NCT01965431|141541737|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.42|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|90.0|-5.98|-2.87|||||Minimum mean difference to placebo is estimated. Adjusted means are based on a mixed model for repeated measures with 'global' \& 'period-global baseline' covariates. Toeplitz covariance model used for modelling the random and repeated effect.|No formal hypothesis testing was done.||-2.87|-5.98|
71017305|NCT04342130|141541772|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71017306|NCT03901339|141541776|OTHER||Hazard Ratio (HR)|0.653||||0.0001|TWO_SIDED|95.0|0.526|0.812||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis and endocrine therapy in the metastatic setting for at least 6 months.|Log Rank|||||0.812|0.526|0.0001
71050770|NCT02912650|141608100|SUPERIORITY_OR_OTHER||LS Mean Difference|1.07||||0.013|TWO_SIDED|95.0|0.23|1.92|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.92|0.23|0.013
71050771|NCT02912650|141608100|SUPERIORITY_OR_OTHER||LS Mean Difference|2.69|||<|0.001|TWO_SIDED|95.0|1.83|3.55|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.55|1.83|<0.001
71050772|NCT02912650|141608100|SUPERIORITY_OR_OTHER||LS Mean Difference|2.77|||<|0.001|TWO_SIDED|95.0|1.56|3.98|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.98|1.56|<0.001
71017307|NCT03901339|141541777|OTHER||Hazard Ratio (HR)|0.788||||0.0133|TWO_SIDED|95.0|0.652|0.952||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis, and endocrine therapy in the metastatic setting for at least 6 months.|Log Rank|||||0.952|0.652|0.0133
71017308|NCT03901339|141541778|OTHER||Odds Ratio (OR)|1.662||||0.0268|TWO_SIDED|95.0|1.058|2.609|||Cochran-Mantel-Haenszel|||ORR by BICR Assessment||2.609|1.058|0.0268
71017309|NCT03901339|141541778|OTHER||Odds Ratio (OR)|1.989||||0.0098|TWO_SIDED|95.0|1.174|3.369|||Cochran-Mantel-Haenszel|||ORR by LIR Assessment||3.369|1.174|0.0098
71017310|NCT03901339|141541780|OTHER||Odds Ratio (OR)|1.796||||0.0025|TWO_SIDED|95.0|1.227|2.628|||Cochran-Mantel-Haenszel|||CBR by BICR Assessment||2.628|1.227|0.0025
71017311|NCT03901339|141541780|OTHER||Odds Ratio (OR)|1.834||||0.0024|TWO_SIDED|95.0|1.237|2.717|||Cochran-Mantel-Haenszel|||CBR by LIR Assessment||2.717|1.237|0.0024
71017312|NCT03901339|141541781|OTHER||Hazard Ratio (HR)|0.728||||0.001|TWO_SIDED|95.0|0.602|0.881||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis, and endocrine therapy in the metastatic setting for at least 6 months.|Log Rank|||||0.881|0.602|0.0010
71017313|NCT03901339|141541782|OTHER||Hazard Ratio (HR)|0.751||||0.0059|TWO_SIDED|95.0|0.612|0.922||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis, and endocrine therapy in the metastatic setting for at least 6 months.|Log Rank|||||0.922|0.612|0.0059
71017314|NCT03901339|141541783|OTHER||Hazard Ratio (HR)|0.918||||0.4151|TWO_SIDED|95.0|0.748|1.126||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis, and endocrine therapy in the metastatic setting for at least 6 months.|Log Rank|||||1.126|0.748|0.4151
71017315|NCT03901339|141541784|OTHER||Hazard Ratio (HR)|0.732||||0.0021|TWO_SIDED|95.0|0.598|0.894||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis, and endocrine therapy in the metastatic setting for at least 6 months.|Log Rank|||||0.894|0.598|0.0021
71017316|NCT01785472|141541808|NON_INFERIORITY_OR_EQUIVALENCE|The statistical test was made at a one-sided significance level of 0.025.|least Square Means net difference|-2.33|STANDARD_ERROR_OF_MEAN|0.85|<|0.001||95.0|-4.0|-0.66|||ANCOVA|||||-0.66|-4.00|<0.001
71050773|NCT02912650|141608100|SUPERIORITY_OR_OTHER||LS Mean Difference|1.15||||0.064|TWO_SIDED|95.0|-0.07|2.37|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.37|-0.07|0.064
70931674|NCT03801148|141364088|EQUIVALENCE|ln-transformed- AUClast, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 60 mg capsule manufactured at TOB compared with dexlansoprazole 60 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUClast.|Geometric LSM ratio|1.061|||||TWO_SIDED|90.0|1.0192|1.1046||||||||1.1046|1.0192|
71017317|NCT02723786|141541836|OTHER||||||||||||||||||The proportion of participants with DGF was 0.57, highest Posterior Density (HPD) 95% Credible interval (CI) (0.25,0.90). The posterior probability for the proportion of participants with DGF \<30% was 0.07 (HPD 95% CI \[0.00,1.00\]). The posterior probability for the proportion of participants with DGF \<50% was 0.34 (HPD 95% CI \[0.00,1.00\]).|||
71050774|NCT02912650|141608100|SUPERIORITY_OR_OTHER||LS Mean Difference|1.62|||<|0.001|TWO_SIDED|95.0|0.76|2.47|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.47|0.76|<0.001
70931675|NCT03801148|141364089|EQUIVALENCE|ln-transformed- AUC0\_infobs, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 30 mg capsule manufactured at TOB compared with dexlansoprazole 30 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUC0\_infobs.|Geometric LSM ratio|1.0553|||||TWO_SIDED|90.0|1.0186|1.0933||||||||1.0933|1.0186|
71017318|NCT03123120|141541855|OTHER||Risk Difference (RD)|-0.232|||||TWO_SIDED|95.0|-0.568|0.118|||||Risk difference was calculated as the observed proportion of response from Spesolimab minus the one from Placebo. Newcombe method was used in the calculation of the 95% confidence interval around the risk difference.|||0.118|-0.568|
71017319|NCT03123120|141541856|OTHER||Risk Difference (RD)|-0.054|||||TWO_SIDED|95.0|-0.404|0.21|||||Risk difference was calculated as the observed proportion of response from Spesolimab minus the one from Placebo. Newcombe method was used in the calculation of the 95% confidence interval around the risk difference.|||0.210|-0.404|
71017320|NCT03123120|141541857|OTHER||Risk Difference (RD)|-0.286|||||TWO_SIDED|95.0|-0.602|0.101|||||Risk difference was calculated as the observed proportion of response from Spesolimab minus the one from Placebo. Newcombe method was used in the calculation of the 95% confidence interval around the risk difference.|||0.101|-0.602|
71017321|NCT03123120|141541858|OTHER||Risk Difference (RD)|0.143|||||TWO_SIDED|95.0|-0.197|0.399|||||Risk difference was calculated as the observed proportion of response from Spesolimab minus the one from Placebo. Newcombe method was used in the calculation of the 95% confidence interval around the risk difference.|||0.399|-0.197|
71017322|NCT00203892|141541860|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.028
71050775|NCT02912650|141608101|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
71050776|NCT02912650|141608101|SUPERIORITY_OR_OTHER|||||||0.069|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.069
71050777|NCT02912650|141608101|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
71105295|NCT03330847|141717889|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.7879|TWO_SIDED|90.0|0.48|1.68|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + adavosertib.|Patient Population BRCAm||1.68|0.48|0.7879
71050778|NCT02912650|141608101|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
71050779|NCT02912650|141608101|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
71105296|NCT03330847|141717889|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.3695|TWO_SIDED|90.0|0.38|1.31|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + ceralasertib.|Patient Population Non BRCAm HRRm||1.31|0.38|0.3695
70941615|NCT04748445|141383933|OTHER||Slope|6.899|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|TWO_SIDED|90.0|||||Mixed Models Analysis|||EE\_Jitter Local Absolute (The statistical data given below have exponential factor in addition to the values mentioned. For estimated value it was 10\^-8).||||<.0001
71017323|NCT00203892|141541861|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||||||>0.99
71017324|NCT00806416|141541862|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Administration of a 70 mg alendronate/2800 IU vitamin D3 final market combination tablet and the 70 mg alendronate market tablet, the GMR of the combination tablet/alendronate only tablet are contained within \[0.80,1.25\].|Least square mean ratio|1.03||||||90.0|0.91|1.17||||||If the true geometric mean ratio (GMR) for total urinary excretion of alendronate of 70 mg alendronate/vitamin D3 combination tablet with respect to alendronate alone is 1.00 then a sample size =208 provided 99% probability of yielding a 90% CI for the total urinary excretion GMR within the interval of \[0.80, 1.25\]. These calculations were based on the observed-pooled within-subject standard deviation (log scale) of 0.521 obtained from earlier Phase 1 studies.||1.17|0.91|
71050780|NCT02912650|141608101|SUPERIORITY_OR_OTHER|||||||0.005|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.005
71050781|NCT02912650|141608102|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-45.27|||<|0.001|TWO_SIDED|95.0|-58.96|-31.58|||Cochran-Mantel-Haenszel|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-31.58|-58.96|<0.001
71050782|NCT02912650|141608102|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-8.88||||0.064|TWO_SIDED|95.0|-18.27|0.5|||Cochran-Mantel-Haenszel|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||0.50|-18.27|0.064
70851098|NCT01584440|141190393|SUPERIORITY||OLS Z-statistic|-1.08||||0.279|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.279
70851099|NCT01584440|141190393|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.76|||||TWO_SIDED||||||||Day 8|||||
71050783|NCT02912650|141608102|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-26.98|||<|0.001|TWO_SIDED|95.0|-36.91|-17.05|||ANOVA|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-17.05|-36.91|<0.001
70851100|NCT01584440|141190393|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.02|||||TWO_SIDED||||||||Day 22|||||
70851101|NCT01584440|141190393|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.74|||||TWO_SIDED||||||||Day 43|||||
70851102|NCT01584440|141190393|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.05|||||TWO_SIDED||||||||Day 57|||||
70851103|NCT01584440|141190394|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0001|TWO_SIDED|95.0|1.62|4.5|||ANCOVA||Day 36|||4.50|1.62|0.0001
70851104|NCT01584440|141190394|SUPERIORITY||Odds Ratio (OR)|1.61||||0.2184|TWO_SIDED|95.0|0.75|3.43|||ANCOVA||Day 70|||3.43|0.75|0.2184
70851105|NCT01584440|141190395|SUPERIORITY||Odds Ratio (OR)|2.45||||0.0266|TWO_SIDED|95.0|1.11|5.42|||ANCOVA|||||5.42|1.11|0.0266
70851106|NCT01584440|141190396|SUPERIORITY||Odds Ratio (OR)|2.16||||0.002|TWO_SIDED|95.0|1.31|3.55|||ANCOVA||Day 36|||3.55|1.31|0.002
70851107|NCT01584440|141190396|SUPERIORITY||Odds Ratio (OR)|2.32||||0.031|TWO_SIDED|95.0|1.08|5.0|||ANCOVA||Day 70|||5.00|1.08|0.031
71050784|NCT02912650|141608102|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-36.26|||<|0.001|TWO_SIDED|95.0|-50.45|-22.07|||Cochran-Mantel-Haenszel|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-22.07|-50.45|<0.001
71050785|NCT02912650|141608102|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-18.58||||0.01|TWO_SIDED|95.0|-32.64|-4.52|||Cochran-Mantel-Haenszel|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-4.52|-32.64|0.010
71050786|NCT02912650|141608102|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-18.17|||<|0.001|TWO_SIDED|95.0|-28.44|-7.9|||Cochran-Mantel-Haenszel|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-7.90|-28.44|<0.001
71050787|NCT02912650|141608102|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-57.58|||<|0.001|TWO_SIDED|95.0|-70.44|-44.72|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-44.72|-70.44|<0.001
71050788|NCT02912650|141608102|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-11.28||||0.004|TWO_SIDED|95.0|-18.99|-3.57|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-3.57|-18.99|0.004
71050789|NCT02912650|141608102|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-28.06|||<|0.001|TWO_SIDED|95.0|-36.77|-19.35|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-19.35|-36.77|<0.001
71050790|NCT02912650|141608102|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-46.01|||<|0.001|TWO_SIDED|95.0|-59.98|-32.04|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-32.04|-59.98|<0.001
71050791|NCT02912650|141608102|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-29.7|||<|0.001|TWO_SIDED|95.0|-43.65|-15.75|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-15.75|-43.65|<0.001
71050792|NCT02912650|141608102|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-16.94|||<|0.001|TWO_SIDED|95.0|-26.59|-7.29|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-7.29|-26.59|<0.001
71050793|NCT02912650|141608103|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
71050794|NCT02912650|141608103|SUPERIORITY_OR_OTHER|||||||0.003|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.003
71050795|NCT02912650|141608103|SUPERIORITY_OR_OTHER|||||||0.031|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.031
71050796|NCT02912650|141608103|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
71050797|NCT02912650|141608103|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
71050798|NCT02912650|141608103|SUPERIORITY_OR_OTHER|||||||0.631|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.631
71050799|NCT02912650|141608104|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
71050800|NCT02912650|141608104|SUPERIORITY_OR_OTHER|||||||0.088|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.088
71050801|NCT02912650|141608104|SUPERIORITY_OR_OTHER|||||||0.133|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.133
71050802|NCT02912650|141608104|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
71050803|NCT02912650|141608104|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
70931676|NCT03801148|141364089|EQUIVALENCE|ln-transformed- AUC0\_infobs, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 60 mg capsule manufactured at TOB compared with dexlansoprazole 60 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUC0\_infobs.|GMR|1.0468|||||TWO_SIDED|90.0|1.0027|1.0929||||||||1.0929|1.0027|
71105297|NCT03330847|141717889|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.4586|TWO_SIDED|90.0|0.29|1.58|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + adavosertib.|Patient Population Non BRCAm HRRm||1.58|0.29|0.4586
71105298|NCT03330847|141717889|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.7452|TWO_SIDED|90.0|0.61|1.31|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + ceralasertib.|Patient Population Non HRRm||1.31|0.61|0.7452
71105299|NCT03330847|141717889|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.1185|TWO_SIDED|90.0|0.37|1.0|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + adavosertib.|Patient Population Non HRRm||1.00|0.37|0.1185
71105300|NCT01355627|141717899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82|STANDARD_ERROR_OF_MEAN|0.23||0.485|||||||Regression, Logistic|Treatment and pooled centre as covariates.|\< 1 implies a smaller likelihood of a TachoSil treated patient to experience a CSF leak.|||||0.485
71105301|NCT02293551|141717907|SUPERIORITY_OR_OTHER_LEGACY||Geometric Ratio of Least Squares Mean|1.04||||0.2071|TWO_SIDED|90.0|0.988|1.1|||Log Rank|Log (PK) model included treatment, period, and sequence group as fixed effects and participant as a random effect.||||1.10|0.988|0.2071
71017325|NCT00806416|141541863|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Administration of a 70 mg alendronate/2800 IU vitamin D3 final market combination tablet and a tablet containing 2800 IU vitamin D3, the geometric mean ratio (GMR) for AUC0-120 hr and Cmax, corrected for predose concentration, of the combination tablet/2800 IU vitamin D3 only tablet were contained within \[0.80,1.25\].|Least square mean ratio for AUC0-120 hr|0.88||||||90.0|0.81|0.95||||||If the true GMRs for AUC and Cmax for 70 mg alendronate/vitamin D3 combination tablet with respect to 2800 IU vitamin D3 alone were 1.00 then a sample size=28 provided \>99% probability of yielding a 90% CI for both AUC(0-120 hr) and Cmax GMRs within the interval of \[0.80, 1.25\]. The within-subject standard deviation of 0.14 ln ng•hr/mL for AUC(0-120 hr) (ng•hr/mL) and 0.14 ng/mL for Cmax was obtained from another phase 1 study.||0.95|0.81|
71017326|NCT00806416|141541864|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Administration of a 70 mg alendronate/2800 IU vitamin D3 final market combination tablet and a tablet containing 2800 IU vitamin D3, the geometric mean ratio (GMR) for AUC0-120 hr and Cmax, corrected for predose concentration, of the combination tablet/2800 IU vitamin D3 only tablet were contained within \[0.80,1.25\].|least-squares mean for Cmax|0.89||||||90.0|0.84|0.95||||||If the true GMR ratios for AUC and Cmax for 70 mg alendronate/vitamin D3 combination tablet with respect to 2800 IU vitamin D3 alone were 1.00 then a sample of N=28 provided \>99% probability of yielding a 90% CI for both AUC0-120 hr and Cmax GMRs within the interval of \[0.80, 1.25\]. The within-subject standard deviation of 0.14 ln ng•hr/mL for AUC0-120 hr (ng•hr/mL) and 0.14 ng/mL for Cmax was obtained from another phase 1 study.||0.95|0.84|
71017327|NCT02701049|141541871|OTHER|Among 109,994 patients who entered the ED during Mode 1, 19,742 had SOGI collected (18%). Among 88,143 patients who entered the ED during Mode 2, 3,630 had SOGI collected (4%).||||||||||||||||Historical controls included all patients entering participating EDs as identified by the Electronic Health Record.|Results were compared to historical control population from an electronic health record database, no other data were collected for these participants.|||
71017328|NCT03359473|141541885|OTHER||Mean Difference (Net)|4.53|||||TWO_SIDED|90.0|-1.3|10.36|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||10.36|-1.30|
71017329|NCT03359473|141541885|OTHER||Mean Difference (Net)|7.8|||||TWO_SIDED|90.0|0.83|14.76|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||14.76|0.83|
71017330|NCT03359473|141541886|OTHER||Mean Difference (Net)|16.71|||||TWO_SIDED|90.0|9.86|23.56|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||23.56|9.86|
71017331|NCT03359473|141541886|OTHER||Mean Difference (Net)|5.35|||||TWO_SIDED|90.0|-4.09|14.78|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||14.78|-4.09|
71017332|NCT03359473|141541887|OTHER||Mean Difference (Net)|5.17|||||TWO_SIDED|90.0|-4.67|15.01|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||15.01|-4.67|
71017333|NCT03359473|141541887|OTHER||Mean Difference (Net)|7.02|||||TWO_SIDED|90.0|0.46|13.58|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||13.58|0.46|
71017334|NCT03359473|141541888|OTHER||Mean Difference (Net)|5.9|||||TWO_SIDED|90.0|-1.4|13.2|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||13.2|-1.4|
71017335|NCT03359473|141541888|OTHER||Mean Difference (Net)|13.5|||||TWO_SIDED|90.0|1.6|25.5|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||25.5|1.6|
70851108|NCT01584440|141190397|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0048|TWO_SIDED|95.0|1.31|4.46|||ANCOVA|||||4.46|1.31|0.0048
71017336|NCT03359473|141541889|OTHER||Mean Difference (Net)|20.7|||||TWO_SIDED|90.0|10.1|31.2|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||31.2|10.1|
70931677|NCT03801148|141364090|EQUIVALENCE|ln-transformed- AUC0\_infpred, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 30 mg capsule manufactured at TOB compared with dexlansoprazole 30 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUC0\_infpred.|Geometric LSM ratio|1.0555|||||TWO_SIDED|90.0|1.0188|1.0935||||||||1.0935|1.0188|
71017337|NCT03359473|141541889|OTHER||Mean Difference (Net)|7.3|||||TWO_SIDED|90.0|-11.1|25.8|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||25.8|-11.1|
71017338|NCT03359473|141541890|OTHER||Mean Difference (Net)|8.0|||||TWO_SIDED|90.0|-2.5|18.4|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||18.4|-2.5|
71017339|NCT03359473|141541890|OTHER||Mean Difference (Net)|11.8|||||TWO_SIDED|90.0|-0.5|24.0|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||24.0|-0.5|
71017340|NCT03359473|141541891|OTHER||Mean Difference (Net)|0.882|||||TWO_SIDED|90.0|0.643|1.121|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline appendicular lean mass, with Day as the repeated factor.|||1.121|0.643|
71017341|NCT03359473|141541891|OTHER||Mean Difference (Net)|0.291|||||TWO_SIDED|90.0|-0.156|0.738|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline appendicular lean mass, with Day as the repeated factor.|||0.738|-0.156|
71017342|NCT03359473|141541892|OTHER||Mean Difference (Net)|0.982|||||TWO_SIDED|90.0|0.629|1.334|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline appendicular lean mass, with Day as the repeated factor.|||1.334|0.629|
71017343|NCT03359473|141541892|OTHER||Mean Difference (Net)|1.127|||||TWO_SIDED|90.0|0.682|1.571|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline appendicular lean mass, with Day as the repeated factor.|||1.571|0.682|
71017344|NCT03359473|141541893|OTHER||Mean Difference (Net)|1.38|||||TWO_SIDED|90.0|0.964|1.795|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline appendicular lean mass, with Day as the repeated factor.|||1.795|0.964|
71017345|NCT03359473|141541893|OTHER||Mean Difference (Net)|1.124|||||TWO_SIDED|90.0|0.594|1.654|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline appendicular lean mass, with Day as the repeated factor.|||1.654|0.594|
71017346|NCT03359473|141541894|OTHER||Mean Difference (Net)|1.167|||||TWO_SIDED|90.0|0.677|1.658|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline total lean mass, with Day as the repeated factor.|||1.658|0.677|
71017347|NCT03359473|141541894|OTHER||Mean Difference (Net)|0.923|||||TWO_SIDED|90.0|0.222|1.623|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline total lean mass, with Day as the repeated factor.|||1.623|0.222|
71017348|NCT03359473|141541895|OTHER||Mean Difference (Net)|2.085|||||TWO_SIDED|90.0|1.493|2.678|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline total lean mass, with Day as the repeated factor.|||2.678|1.493|
71017349|NCT03359473|141541895|OTHER||Mean Difference (Net)|1.7|||||TWO_SIDED|90.0|0.801|2.6|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline total lean mass, with Day as the repeated factor.|||2.600|0.801|
71017350|NCT03359473|141541896|OTHER||Mean Difference (Net)|2.108|||||TWO_SIDED|90.0|1.271|2.945|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline total lean mass, with Day as the repeated factor.|||2.945|1.271|
71017351|NCT03359473|141541896|OTHER||Mean Difference (Net)|2.113|||||TWO_SIDED|90.0|0.949|3.277|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline total lean mass, with Day as the repeated factor.|||3.277|0.949|
71017352|NCT03359473|141541897|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|90.0|-0.6|0.6|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline SPPB total score, with Day as the repeated factor.|||0.6|-0.6|
71017353|NCT03359473|141541897|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|90.0|-0.4|0.5|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline SPPB total score, with Day as the repeated factor.|||0.5|-0.4|
71017354|NCT03359473|141541898|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|90.0|-0.6|0.6|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline SPPB total score, with Day as the repeated factor.|||0.6|-0.6|
71017355|NCT03359473|141541898|OTHER||Mean Difference (Net)|0.3|||||TWO_SIDED|90.0|-0.2|0.9|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline SPPB total score, with Day as the repeated factor.|||0.9|-0.2|
70941616|NCT04748445|141383933|OTHER||Slope|-1.743|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|TWO_SIDED|90.0|||||Mixed Models Analysis|||MM\_Jitter Local Absolute (The statistical data given below have exponential factor in addition to the values mentioned. For estimated value it was 10\^-7).||||<.0001
71017356|NCT03359473|141541899|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|90.0|-0.4|0.9|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline SPPB total score, with Day as the repeated factor.|||0.9|-0.4|
71017357|NCT03359473|141541899|OTHER||Mean Difference (Net)|0.1|||||TWO_SIDED|90.0|-0.5|0.6|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline SPPB total score, with Day as the repeated factor.|||0.6|-0.5|
71017358|NCT03359473|141541900|OTHER||Mean Difference (Net)|-0.553|||||TWO_SIDED|90.0|-2.082|0.977|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.|||0.977|-2.082|
71017359|NCT03359473|141541900|OTHER||Mean Difference (Net)|-0.073|||||TWO_SIDED|90.0|-0.977|0.832|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.|||0.832|-0.977|
71017360|NCT03359473|141541901|OTHER||Mean Difference (Net)|-0.816|||||TWO_SIDED|90.0|-2.252|0.619|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.|||0.619|-2.252|
71017361|NCT03359473|141541901|OTHER||Mean Difference (Net)|0.163|||||TWO_SIDED|90.0|-1.096|1.422|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.|||1.422|-1.096|
71017362|NCT03359473|141541902|OTHER||Mean Difference (Net)|-0.96|||||TWO_SIDED|90.0|-2.668|0.748|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.|||0.748|-2.668|
71017363|NCT03359473|141541902|OTHER||Mean Difference (Net)|-1.937|||||TWO_SIDED|90.0|-5.208|1.333|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.|||1.333|-5.208|
71017364|NCT03359473|141541903|OTHER||Mean Difference (Net)|-0.04|||||TWO_SIDED|90.0|-0.314|0.233|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.|||0.233|-0.314|
71017365|NCT03359473|141541903|OTHER||Mean Difference (Net)|0.058|||||TWO_SIDED|90.0|-0.209|0.324|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.|||0.324|-0.209|
71017366|NCT03359473|141541904|OTHER||Mean Difference (Net)|-0.287|||||TWO_SIDED|90.0|-0.65|0.077|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.|||0.077|-0.650|
71017367|NCT03359473|141541904|OTHER||Mean Difference (Net)|-0.191|||||TWO_SIDED|90.0|-0.534|0.152|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.|||0.152|-0.534|
71017368|NCT03359473|141541905|OTHER||Mean Difference (Net)|-0.012|||||TWO_SIDED|90.0|-0.555|0.532|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.|||0.532|-0.555|
71017369|NCT03359473|141541905|OTHER||Mean Difference (Net)|-0.231|||||TWO_SIDED|90.0|-0.541|0.08|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.|||0.080|-0.541|
71017370|NCT03359473|141541906|OTHER||Difference in Least Square Means|11.1|||||TWO_SIDED|90.0|-57.1|79.2|||||Analysis was performed by ANCOVA model with Baseline CWR duration as the covariate adjusting for the treatment.|||79.2|-57.1|
71017371|NCT03359473|141541906|OTHER||Difference in Least Square Means|-149.3|||||TWO_SIDED|90.0|-280.6|-18.1|||||Analysis was performed by ANCOVA model with Baseline CWR duration as the covariate adjusting for the treatment.|||-18.1|-280.6|
71017372|NCT03359473|141541907|OTHER||Difference in Least Square Means|-6.7|||||TWO_SIDED|90.0|-42.7|29.2|||||Analysis was performed by ANCOVA model with Baseline peak performance as the covariate adjusting for the treatment.|||29.2|-42.7|
71050804|NCT02912650|141608104|SUPERIORITY_OR_OTHER|||||||0.887|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.887
71050805|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|||<|0.001|TWO_SIDED|95.0|0.14|0.52|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.52|0.14|<0.001
71050806|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.15||||0.034|TWO_SIDED|95.0|0.01|0.28|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.28|0.01|0.034
71050807|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.963|TWO_SIDED|95.0|-0.13|0.14|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.14|-0.13|0.963
71050808|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.062|TWO_SIDED|95.0|-0.01|0.37|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.37|-0.01|0.062
71050809|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.001|TWO_SIDED|95.0|0.13|0.52|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.52|0.13|0.001
71050810|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14||||0.04|TWO_SIDED|95.0|-0.28|-0.01|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||-0.01|-0.28|0.040
71017373|NCT03359473|141541907|OTHER||Difference in Least Square Means|-34.8|||||TWO_SIDED|90.0|-72.0|2.4|||||Analysis was performed by ANCOVA model with Baseline peak performance as the covariate adjusting for the treatment.|||2.4|-72.0|
71017374|NCT03359473|141541908|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|90.0|-2.6|1.9|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline CAT score, with Day as the repeated factor.|||1.9|-2.6|
71017375|NCT03359473|141541908|OTHER||Mean Difference (Net)|-0.7|||||TWO_SIDED|90.0|-3.4|2.1|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline CAT score, with Day as the repeated factor.|||2.1|-3.4|
71050811|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.99|||<|0.001|TWO_SIDED|95.0|0.7|1.27|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.27|0.70|<0.001
71050812|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17||||0.095|TWO_SIDED|95.0|-0.03|0.37|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.37|-0.03|0.095
71050813|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.414|TWO_SIDED|95.0|-0.12|0.29|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.29|-0.12|0.414
71050814|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81|||<|0.001|TWO_SIDED|95.0|0.52|1.1|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.10|0.52|<0.001
71017376|NCT03359473|141541909|OTHER||Mean Difference (Net)|-0.9|||||TWO_SIDED|90.0|-2.9|1.1|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline CAT score, with Day as the repeated factor.|||1.1|-2.9|
71017377|NCT03359473|141541909|OTHER||Mean Difference (Net)|2.2|||||TWO_SIDED|90.0|0.0|4.5|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline CAT score, with Day as the repeated factor.|||4.5|0.0|
71050815|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|||<|0.001|TWO_SIDED|95.0|0.61|1.19|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.19|0.61|<0.001
71017378|NCT03359473|141541910|OTHER||Mean Difference (Net)|-4.7|||||TWO_SIDED|90.0|-8.9|-0.6|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline difficulty scores, with Day as the repeated factor.|||-0.6|-8.9|
71050816|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09||||0.406|TWO_SIDED|95.0|-0.29|0.12|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.12|-0.29|0.406
70851109|NCT00531427|141190400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.0853|TWO_SIDED|95.0|-0.8|0.05|||Mixed Models Analysis|Statistics are based on a mixed effect general linear model||"\[Week 12 analysis\] The null hypothesis was no group differences. The alternative hypothesis was that BTDS arm was superior to the placebo arm.~Pain scale is 11 points (0 = no pain to 10 = pain as bad as you can imagine)."||0.05|-0.80|0.0853
70851110|NCT00531427|141190401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.037||||0.7098|TWO_SIDED|95.0|-0.233|0.159||To control multiplicity and family-wise error rate, a gate-keeping strategy (stepwise approach) was used to evaluate the statistical significance of the secondary variables. If the primary is negative, the secondary P values are descriptive only.|ANCOVA|with treatment as a factor and screening and pre-randomization mean pain as covariates.||Categorical analysis P value is based on a Fisher's exact test. Mean daily number of tablets for subjects who took \<=1 dose of supplemental analgesia||0.159|-0.233|0.7098
71050817|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|1.75|||<|0.001|TWO_SIDED|95.0|1.4|2.09|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.09|1.40|<0.001
71050818|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34||||0.006|TWO_SIDED|95.0|0.1|0.58|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.58|0.10|0.006
71050819|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33||||0.009|TWO_SIDED|95.0|0.08|0.57|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.57|0.08|0.009
71105302|NCT02293551|141717907|SUPERIORITY_OR_OTHER_LEGACY||Geometric Ratio of Least Square Means|1.11||||0.0005|TWO_SIDED|90.0|1.06|1.17|||Log Rank|Log (PK) model included treatment, period, and sequence group as fixed effects and participant as a random effect.||||1.17|1.06|0.0005
71017379|NCT03359473|141541910|OTHER||Mean Difference (Net)|-2.1|||||TWO_SIDED|90.0|-7.2|3.1|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline difficulty scores, with Day as the repeated factor.|||3.1|-7.2|
71017380|NCT03359473|141541911|OTHER||Mean Difference (Net)|-4.9|||||TWO_SIDED|90.0|-9.5|-0.4|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline difficulty scores, with Day as the repeated factor.|||-0.4|-9.5|
71017381|NCT03359473|141541911|OTHER||Mean Difference (Net)|-4.1|||||TWO_SIDED|90.0|-10.3|2.2|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline difficulty scores, with Day as the repeated factor.|||2.2|-10.3|
71050820|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|1.41|||<|0.001|TWO_SIDED|95.0|1.07|1.75|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.75|1.07|<0.001
71050821|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|1.42|||<|0.001|TWO_SIDED|95.0|1.08|1.77|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.77|1.08|<0.001
71050822|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01||||0.908|TWO_SIDED|95.0|-0.26|0.23|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.23|-0.26|0.908
71050823|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|1.99|||<|0.001|TWO_SIDED|95.0|1.64|2.35|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.35|1.64|<0.001
70931678|NCT03801148|141364090|EQUIVALENCE|ln-transformed- AUC0\_infpred, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 60 mg capsule manufactured at TOB compared with dexlansoprazole 60 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUC0\_infpred.|Geometric LSM ratio|1.0472|||||TWO_SIDED|90.0|1.0029|1.0934||||||||1.0934|1.0029|
71017382|NCT03359473|141541912|OTHER||Mean Difference (Net)|-3.1|||||TWO_SIDED|90.0|-5.9|-0.3|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline amount scores, with Day as the repeated factor.|||-0.3|-5.9|
71017383|NCT03359473|141541912|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|90.0|-4.6|4.2|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline amount scores, with Day as the repeated factor.|||4.2|-4.6|
71050824|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39||||0.002|TWO_SIDED|95.0|0.15|0.64|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.64|0.15|0.002
71050825|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57|||<|0.001|TWO_SIDED|95.0|0.32|0.82|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.82|0.32|<0.001
71050826|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|||<|0.001|TWO_SIDED|95.0|1.25|1.95|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.95|1.25|<0.001
71050827|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|1.42|||<|0.001|TWO_SIDED|95.0|1.07|1.78|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.78|1.07|<0.001
71050828|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.157|TWO_SIDED|95.0|-0.07|0.43|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.43|-0.07|0.157
71017384|NCT03359473|141541913|OTHER||Mean Difference (Net)|4.0|||||TWO_SIDED|90.0|-0.8|8.8|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline amount scores, with Day as the repeated factor.|||8.8|-0.8|
71017385|NCT03359473|141541913|OTHER||Mean Difference (Net)|3.5|||||TWO_SIDED|90.0|-2.3|9.4|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline amount scores, with Day as the repeated factor.|||9.4|-2.3|
71105303|NCT02293551|141717907|SUPERIORITY_OR_OTHER_LEGACY||Geometric of Ratio Least Square Means|1.08||||0.0123|TWO_SIDED|90.0|1.03|1.13|||Log Rank|Log (PK) model included treatment, period, and sequence group as fixed effects and participant as a random effect.||||1.13|1.03|0.0123
71105304|NCT02293551|141717907|SUPERIORITY_OR_OTHER_LEGACY||Geometric Ratio of Least Square Means|1.07||||0.0331|TWO_SIDED|90.0|1.02|1.13|||Log Rank|Log (PK) model included treatment, period, and sequence group as fixed effects and participant as a random effect.||||1.13|1.02|0.0331
70931679|NCT03614663|141364111|SUPERIORITY|||||||0.321|||||||MMRM - Mixed model for repeated measures|||||||0.321
71017386|NCT03359473|141541914|OTHER||Mean Difference (Net)|-4.2|||||TWO_SIDED|90.0|-6.5|-1.9|||||Analysis was performed by mixed model repeated measures including the covariates; treatment, Day, treatment\*Day and corresponding Baseline total scores, with Day as the repeated factor.|||-1.9|-6.5|
71017387|NCT03359473|141541914|OTHER||Mean Difference (Net)|-1.5|||||TWO_SIDED|90.0|-4.1|1.1|||||Analysis was performed by mixed model repeated measures including the covariates; treatment, Day, treatment\*Day and corresponding Baseline total scores, with Day as the repeated factor.|||1.1|-4.1|
71017388|NCT03359473|141541915|OTHER||Mean Difference (Net)|-1.0|||||TWO_SIDED|90.0|-3.8|1.8|||||Analysis was performed by mixed model repeated measures including the covariates; treatment, Day, treatment\*Day and corresponding Baseline total scores, with Day as the repeated factor.|||1.8|-3.8|
71017389|NCT03359473|141541915|OTHER||Mean Difference (Net)|-0.7|||||TWO_SIDED|90.0|-4.6|3.2|||||Analysis was performed by mixed model repeated measures including the covariates; treatment, Day, treatment\*Day and corresponding Baseline total scores, with Day as the repeated factor.|||3.2|-4.6|
71050829|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1|||<|0.001|TWO_SIDED|95.0|1.73|2.48|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.48|1.73|<0.001
71050830|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.005|TWO_SIDED|95.0|0.11|0.63|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.63|0.11|0.005
71050831|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.79|||<|0.001|TWO_SIDED|95.0|0.52|1.05|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.05|0.52|<0.001
71050832|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|1.73|||<|0.001|TWO_SIDED|95.0|1.36|2.1|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.10|1.36|<0.001
71050833|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|1.31|||<|0.001|TWO_SIDED|95.0|0.94|1.69|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.69|0.94|<0.001
71050834|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.42||||0.002|TWO_SIDED|95.0|0.15|0.68|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.68|0.15|0.002
71050835|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|2.06|||<|0.001|TWO_SIDED|95.0|1.67|2.45|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.45|1.67|<0.001
71050836|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.004|TWO_SIDED|95.0|0.13|0.67|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.67|0.13|0.004
71105305|NCT02293551|141717907|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.11|||||TWO_SIDED|90.0|1.06|1.16|||||Dose proportionality and the degree of dose proportionality was assessed by fitting the power model versus dose. Estimated ratio of dose-normalized geometric means of PK parameters between the highest and lowest doses assessed dose proportionality.|||1.16|1.06|
71050837|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|||<|0.001|TWO_SIDED|95.0|0.82|1.37|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.37|0.82|<0.001
71050838|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|1.66|||<|0.001|TWO_SIDED|95.0|1.27|2.04|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.04|1.27|<0.001
71050839|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.97|||<|0.001|TWO_SIDED|95.0|0.58|1.36|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.36|0.58|<0.001
71050840|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.69|||<|0.001|TWO_SIDED|95.0|0.42|0.96|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.96|0.42|<0.001
71050841|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0|||<|0.001|TWO_SIDED|95.0|1.6|2.4|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.40|1.60|<0.001
71050842|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44||||0.002|TWO_SIDED|95.0|0.16|0.72|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.72|0.16|0.002
71050843|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|1.16|||<|0.001|TWO_SIDED|95.0|0.88|1.44|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.44|0.88|<0.001
71050844|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|1.56|||<|0.001|TWO_SIDED|95.0|1.16|1.96|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.96|1.16|<0.001
71050845|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.84|||<|0.001|TWO_SIDED|95.0|0.44|1.24|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.24|0.44|<0.001
71105306|NCT04756531|141717923|OTHER|Natural log transformed AUClast for PF-07321332 was analyzed using a mixed effect model with sequence, period, and treatment included as fixed effects and subject nested within sequence as a random effect. PF-07321332 250 mg (Tablet), Fasted was the test treatment and PF-07321332 250 mg (Suspension), Fasted was the reference treatment.|Ratio of Adjusted Geometric Means|81.21|||||TWO_SIDED|90.0|69.21|95.28||||||||95.28|69.21|
70851111|NCT00531427|141190402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.46||||0.0034|TWO_SIDED|95.0|-7.44|-1.48||To control multiplicity and family-wise error rate, a gate-keeping strategy (stepwise approach) was used to evaluate the statistical significance of the secondary variables. If the primary is negative, the secondary P values are descriptive only.|Mixed Models Analysis|||Weeks 4, 8, 12 analysis The sleep disturbance subscale was analyzed using the mixed effect linear model with fixed effects for treatment (BTDS or placebo) and time (weeks 1, 2, 4, 8, 12) as categorical, screening mean and prerandomization mean value as covariates, and subject as a random effect.||-1.48|-7.44|0.0034
71050846|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.72|||<|0.001|TWO_SIDED|95.0|0.44|1.0|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.00|0.44|<0.001
71050847|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|1.91|||<|0.001|TWO_SIDED|95.0|1.5|2.31|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.31|1.50|<0.001
71050848|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46||||0.001|TWO_SIDED|95.0|0.18|0.74|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.74|0.18|0.001
71050849|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|1.14|||<|0.001|TWO_SIDED|95.0|0.85|1.43|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.43|0.85|<0.001
71050850|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|1.45|||<|0.001|TWO_SIDED|95.0|1.04|1.85|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.85|1.04|<0.001
71050851|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.77|||<|0.001|TWO_SIDED|95.0|0.36|1.17|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.17|0.36|<0.001
71050852|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.68|||<|0.001|TWO_SIDED|95.0|0.39|0.97|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.97|0.39|<0.001
71050853|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|1.55|||<|0.001|TWO_SIDED|95.0|1.13|1.98|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.98|1.13|<0.001
71050854|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36||||0.017|TWO_SIDED|95.0|0.06|0.65|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.65|0.06|0.017
71050855|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|1.07|||<|0.001|TWO_SIDED|95.0|0.77|1.37|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.37|0.77|<0.001
71050856|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2|||<|0.001|TWO_SIDED|95.0|0.78|1.62|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.62|0.78|<0.001
71050857|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48||||0.026|TWO_SIDED|95.0|0.06|0.91|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.91|0.06|0.026
71050858|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.72|||<|0.001|TWO_SIDED|95.0|0.42|1.01|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.01|0.42|<0.001
71017390|NCT03359473|141541920|OTHER||Difference in Least Square Means|3.0|||||TWO_SIDED|90.0|-1.4|7.4|||||Analysis was performed by ANCOVA model with Baseline total score as the covariate adjusting for the treatment.|||7.4|-1.4|
71017391|NCT03359473|141541920|OTHER||Difference in Least Square Means|2.1|||||TWO_SIDED|90.0|-2.3|6.5|||||Analysis was performed by ANCOVA model with Baseline total score as the covariate adjusting for the treatment.|||6.5|-2.3|
71017392|NCT03359473|141541921|OTHER||Difference in Least Square Means|2.6|||||TWO_SIDED|90.0|-5.0|10.1|||||Analysis was performed by ANCOVA model with Baseline symptoms score as the covariate adjusting for the treatment.|||10.1|-5.0|
71017393|NCT03359473|141541921|OTHER||Difference in Least Square Means|-0.5|||||TWO_SIDED|90.0|-8.4|7.5|||||Analysis was performed by ANCOVA model with Baseline symptoms score as the covariate adjusting for the treatment.|||7.5|-8.4|
71017394|NCT03359473|141541922|OTHER||Difference in Least Square Means|2.0|||||TWO_SIDED|90.0|-3.2|7.1|||||Analysis was performed by ANCOVA model with Baseline activity score as the covariate adjusting for the treatment.|||7.1|-3.2|
71017395|NCT03359473|141541922|OTHER||Difference in Least Square Means|0.5|||||TWO_SIDED|90.0|-5.6|6.5|||||Analysis was performed by ANCOVA model with Baseline activity score as the covariate adjusting for the treatment.|||6.5|-5.6|
71017396|NCT03359473|141541923|OTHER||Difference in Least Square Means|3.4|||||TWO_SIDED|90.0|-1.7|8.6|||||Analysis was performed by ANCOVA model with Baseline impact score as the covariate adjusting for the treatment.|||8.6|-1.7|
71017397|NCT03359473|141541923|OTHER||Difference in Least Square Means|3.5|||||TWO_SIDED|90.0|-0.7|7.7|||||Analysis was performed by ANCOVA model with Baseline impact score as the covariate adjusting for the treatment.|||7.7|-0.7|
71017398|NCT05302414|141541928|SUPERIORITY||Median Difference (Final Values)|12.75|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||For the pretest at week 0.||||<0.05
71050859|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|1.27|||<|0.001|TWO_SIDED|95.0|0.84|1.69|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.69|0.84|<0.001
71017399|NCT05302414|141541928|SUPERIORITY||Median Difference (Final Values)|2.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For posttest right after intervention at the 4 weeks.||||0.05
71017400|NCT05302414|141541928|SUPERIORITY||Median Difference (Final Values)|6.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For follow-up test at the 16 weeks.||||0.05
71017401|NCT05302414|141541929|SUPERIORITY||Median Difference (Final Values)|1.0|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||For pretest at the 0 week||||<0.05
71017402|NCT05302414|141541929|SUPERIORITY||Median Difference (Final Values)|0.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For posttest right after intervention at the 4 weeks.||||0.05
71017403|NCT05302414|141541929|SUPERIORITY||Median Difference (Final Values)|0.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For follow-up test at the 16 weeks.||||0.05
71050860|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36||||0.017|TWO_SIDED|95.0|0.07|0.66|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.66|0.07|0.017
71017404|NCT05302414|141541930|SUPERIORITY||Median Difference (Final Values)|40.0|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||For the pretest at week 0.||||<0.05
71017405|NCT05302414|141541930|SUPERIORITY||Median Difference (Final Values)|45.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For posttest right after intervention at the 4 weeks.||||0.05
71017406|NCT05302414|141541930|SUPERIORITY||Median Difference (Final Values)|43.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For follow-up test at the 16 weeks.||||0.05
71017407|NCT05302414|141541931|SUPERIORITY||Median Difference (Final Values)|0.0|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||For the pretest at week 0.||||<0.05
71017408|NCT05302414|141541931|SUPERIORITY||Median Difference (Final Values)|0.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For posttest right after intervention at the 4 weeks.||||0.05
71017409|NCT05302414|141541931|SUPERIORITY||Median Difference (Final Values)|2.5||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For follow-up test at the 16 weeks.||||0.05
71017410|NCT05302414|141541932|SUPERIORITY||Median Difference (Final Values)|6.75|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||For the pretest at week 0.||||<0.05
71017411|NCT05302414|141541932|SUPERIORITY||Median Difference (Final Values)|0.25||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For posttest right after intervention at the 4 weeks.||||0.05
71017412|NCT05302414|141541932|SUPERIORITY||Median Difference (Final Values)|0.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For follow-up test at the 16 weeks.||||0.05
71017413|NCT05302414|141541933|SUPERIORITY||Median Difference (Final Values)|22.0|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||For posttest right after intervention at the 4 weeks.||||<0.05
71017414|NCT01610284|141541934|OTHER|Comparison of progression-free survival (PFS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.78|||<|0.001|TWO_SIDED|95.0|0.67|0.89|||Log Rank|||FAS-Full population||0.89|0.67|<0.001
71017415|NCT01610284|141541934|OTHER|Comparison of progression-free survival (PFS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.8||||0.003|TWO_SIDED|95.0|0.68|0.94|||Log Rank|||FAS-Main cohort||0.94|0.68|0.003
71017416|NCT01610284|141541934|OTHER|Comparison of progression-free survival (PFS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.76||||0.015|TWO_SIDED|95.0|0.6|0.97|||Log Rank|||FAS-PI3K pathway activated||0.97|0.60|0.015
71050861|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|||<|0.001|TWO_SIDED|95.0|0.6|1.2|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.20|0.60|<0.001
71050862|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|||<|0.001|TWO_SIDED|95.0|0.48|1.33|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.33|0.48|<0.001
71050863|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.089|TWO_SIDED|95.0|-0.06|0.8|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.80|-0.06|0.089
71050864|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.53|||<|0.001|TWO_SIDED|95.0|0.24|0.83|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.83|0.24|<0.001
71017417|NCT01610284|141541934|OTHER|Comparison of progression-free survival (PFS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.67|1.03||||||FAS-PI3K pathway non-activated||1.03|0.67|
71017418|NCT01610284|141541934|OTHER|Comparison of progression-free survival (PFS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.52|0.94||||||FAS-PI3K pathway unknown||0.94|0.52|
71017419|NCT01610284|141541935|OTHER|Comparison of overall survival (OS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.87||||0.045|TWO_SIDED|95.0|0.74|1.02|||Log Rank|||FAS-Full population||1.02|0.74|0.045
71017420|NCT01610284|141541935|OTHER|Comparison of overall survival (OS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.91||||0.144|TWO_SIDED|95.0|0.75|1.09|||Log Rank|||FAS-Main cohort||1.09|0.75|0.144
71017421|NCT01610284|141541935|OTHER|Comparison of overall survival (OS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.61|1.08||||||FAS-PI3K pathway activated||1.08|0.61|
71017422|NCT01610284|141541935|OTHER|Comparison of overall survival (OS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.77|1.24||||||FAS-PI3K pathway non-activated||1.24|0.77|
71017423|NCT01610284|141541935|OTHER|Comparison of overall survival (OS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.52|1.06||||||FAS-PI3K pathway unknown||1.06|0.52|
71017424|NCT04035694|141541943|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.08||0.41|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.41
71017425|NCT04035694|141541944|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.11|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||.11
71017426|NCT04035694|141541945|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.09||0.54|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.54
71017427|NCT04035694|141541946|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.11||0.38|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.38
71017428|NCT04035694|141541947|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.07||0.56|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.56
71017429|NCT04035694|141541948|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.08||0.09|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.09
71050865|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|1.02|||<|0.001|TWO_SIDED|95.0|0.6|1.44|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.44|0.60|<0.001
71050866|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.35||||0.018|TWO_SIDED|95.0|0.06|0.65|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.65|0.06|0.018
70931680|NCT03614663|141364112|SUPERIORITY|||||||0.149|||||||MMRM - Mixed model for repeated measures|||||||0.149
70931681|NCT03614663|141364113|SUPERIORITY|||||||0.607|||||||MMRM - Mixed model for repeated measures|||||||0.607
70931682|NCT03614663|141364114|SUPERIORITY|||||||0.426|||||||ANOVA|||||||0.426
71017430|NCT04035694|141541949|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.4|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.40
71017431|NCT04035694|141541950|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.09||0.74|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.74
71017432|NCT04035694|141541951|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.07||0.66|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.66
71017433|NCT04035694|141541952|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.09||0.78|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.78
70851112|NCT00122980|141190429|NON_INFERIORITY_OR_EQUIVALENCE|"Based on pilot data, the efficacy of hydroxyurea to reduce secondary stroke rate was not predicted to be equivalent to transfusions. Therefore, an increased stroke rate (non-inferiority margin = 0.20) was allowed by study design. This acceptable stroke margin was predicted to be offset by the likelihood of significantly greater improvement in the management of iron overload through elimination of transfusions along with serial phlebotomy in the Hydroxyurea/Phlebotomy arm."||||||0.214||95.0|||||Log Rank|||Concluding that Hydroxyurea/Phlebotomy group is better than the Transfusion/Chelation group required rejecting the STROKE null hypothesis in favor of the alternative: Hydroxyurea/Phlebotomy recurrent stroke rate is less than Transfusion/Chelation rate plus 0.20, the non-inferiority margin, AND rejecting the IRON null hypothesis in favor of the alternative: Hydroxyurea/Phlebotomy baseline-adjusted mean LIC is less than for Transfusion/Chelation (see next primary endpoint analysis).||||0.214
71017434|NCT04035694|141541953|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.15||0.52|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.52
71017435|NCT04035694|141541954|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.17||0.74|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.74
70851113|NCT00122980|141190430|SUPERIORITY_OR_OTHER|||||||0.144||95.0||||The a priori defined LOCF approach was deemed to be biased due to the study's early termination, and was replaced by this mixed models analysis.|Mixed Models Analysis|Including main effects of age at consent, baseline iron, and treatment group, on observed change from baseline Log10 transformed values only.||Concluding that Hydroxyurea/Phlebotomy group is better than the Transfusion/Chelation group required rejecting the STROKE null hypothesis (see previous primary endpoint analysis) in favor of the alternative: Hydroxyurea/Phlebotomy recurrent stroke rate is less than Transfusion/Chelation rate plus 0.20 AND rejecting the IRON null hypothesis in favor of the alternative: Hydroxyurea/Phlebotomy baseline-adjusted mean log10 transformed LIC is less than for Transfusion/Chelation.||||0.144
70931683|NCT03614663|141364115|SUPERIORITY|||||||0.02|||||||MMRM - Mixed model for repeated measures|||||||0.02
71017436|NCT04035694|141541955|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Median Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.13||0.21|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.21
71050867|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.72|||<|0.001|TWO_SIDED|95.0|0.42|1.02|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.02|0.42|<0.001
71050868|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.67||||0.002|TWO_SIDED|95.0|0.25|1.09|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.09|0.25|0.002
71017437|NCT04035694|141541956|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.13||0.27|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.27
71017438|NCT04035694|141541957|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Median Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.07||0.01|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.01
71017439|NCT04035694|141541958|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.11||0.23|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.23
70851114|NCT00122980|141190431|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|The change-from-baseline scores for each scale were analyzed with an analysis of variance model (ANOVA) with treatment as stratum.||The change-from-baseline scores were analyzed with an analysis of variance model (ANOVA) with treatment as stratum, testing the hypothesis that the average change from baseline scores do not differ between the treatment groups.||||>0.05
70851115|NCT00122980|141190432|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|The change-from-baseline scores for each scale were analyzed with an analysis of variance model (ANOVA) with treatment as stratum.||The change-from-baseline scores were analyzed with an analysis of variance model (ANOVA) with treatment as stratum.||||>0.05
71017440|NCT04035694|141541959|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.05|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.05
71050869|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.163|TWO_SIDED|95.0|-0.12|0.72|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.72|-0.12|0.163
71050870|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.016|TWO_SIDED|95.0|0.07|0.66|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.66|0.07|0.016
70851116|NCT00122980|141190433|SUPERIORITY_OR_OTHER|||||||0.841||95.0|||||ANOVA|||The change-from-baseline to endpoint scores were analyzed with an analysis of variance model (ANOVA) with treatment as stratum.||||0.841
70851117|NCT00122980|141190434|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||The change-from-baseline scores were analyzed with an analysis of variance model (ANOVA) with treatment as stratum, testing the hypothesis that the average change from baseline scores do not differ between the treatment groups.||||>0.05
71017441|NCT04035694|141541960|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.11||0.95|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.95
71050871|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.68||||0.002|TWO_SIDED|95.0|0.26|1.1|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.10|0.26|0.002
71050872|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.496|TWO_SIDED|95.0|-0.19|0.4|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.40|-0.19|0.496
71050873|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46||||0.003|TWO_SIDED|95.0|0.16|0.76|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.76|0.16|0.003
71050874|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.008|TWO_SIDED|95.0|0.15|1.0|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.00|0.15|0.008
71050875|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.315|TWO_SIDED|95.0|-0.21|0.64|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.64|-0.21|0.315
71050876|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36||||0.019|TWO_SIDED|95.0|0.06|0.66|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.66|0.06|0.019
71050877|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.45||||0.038|TWO_SIDED|95.0|0.02|0.87|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.87|0.02|0.038
71050878|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.918|TWO_SIDED|95.0|-0.28|0.31|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.31|-0.28|0.918
70931684|NCT03614663|141364116|SUPERIORITY|||||||0.091|||||||MMRM - Mixed model for repeated measures|||||||0.091
71017442|NCT04035694|141541961|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.99|STANDARD_ERROR_OF_MEAN|0.72||0.19|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.19
71017443|NCT04035694|141541962|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.59||0.92|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.92
71017444|NCT04035694|141541963|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Median Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.13||0.81|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.81
71017445|NCT04035694|141541964|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.16||0.81|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.81
71017446|NCT04035694|141541965|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.1||0.14|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.14
71050879|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.105|TWO_SIDED|95.0|-0.05|0.55|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.55|-0.05|0.105
71050880|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.43||||0.045|TWO_SIDED|95.0|0.01|0.85|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.85|0.01|0.045
70851118|NCT00122980|141190435|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||ANOVA|||The change-from-baseline scores were analyzed with an analysis of variance model (ANOVA) with treatment as stratum, testing the hypothesis that the average change from baseline scores do not differ between the treatment groups.||||0.039
70851119|NCT00122980|141190436|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||ANCOVA|Analysis controlling for baseline value and time on study.||||||0.033
71017447|NCT04035694|141541966|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.15||0.82|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.82
71050881|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.355|TWO_SIDED|95.0|-0.22|0.62|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.62|-0.22|0.355
71050882|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.127|TWO_SIDED|95.0|-0.07|0.53|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.53|-0.07|0.127
71050883|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29||||0.171|TWO_SIDED|95.0|-0.12|0.7|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.70|-0.12|0.171
71050884|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04||||0.79|TWO_SIDED|95.0|-0.25|0.33|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.33|-0.25|0.790
71050885|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.235|TWO_SIDED|95.0|-0.12|0.47|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.47|-0.12|0.235
70851120|NCT00122980|141190437|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|Controlling for baseline value and time on study||||||<0.01
70931685|NCT03614663|141364117|SUPERIORITY|||||||0.135|||||||MMRM - Mixed model for repeated measures|||||||0.135
70931686|NCT03614663|141364118|SUPERIORITY|||||||0.056|||||||MMRM - Mixed model for repeated measures|||||||0.056
70931687|NCT01128595|141364119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.515|||||TWO_SIDED|95.0|0.33|0.701||||||||0.701|0.330|
70931688|NCT01128595|141364119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.543|||||TWO_SIDED|95.0|0.355|0.73||||||||0.730|0.355|
70931689|NCT01128595|141364119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.195|||||TWO_SIDED|95.0|0.001|0.388||||||||0.388|0.001|
70931690|NCT01128595|141364119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.027|||||TWO_SIDED|95.0|-0.198|0.143||||||||0.143|-0.198|
70931691|NCT01128595|141364119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32|||||TWO_SIDED|95.0|0.14|0.501||||||||0.501|0.140|
71017448|NCT04035694|141541967|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Median Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.97|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.97
71050886|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.236|TWO_SIDED|95.0|-0.16|0.66|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.66|-0.16|0.236
71050887|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.599|TWO_SIDED|95.0|-0.3|0.53|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.53|-0.30|0.599
71050888|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14||||0.353|TWO_SIDED|95.0|-0.15|0.43|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.43|-0.15|0.353
71017449|NCT04035694|141541968|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.09||0.89|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.89
71017450|NCT04035694|141541969|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.69|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.69
71050889|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.293|TWO_SIDED|95.0|-0.19|0.62|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.62|-0.19|0.293
71050890|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.986|TWO_SIDED|95.0|-0.28|0.28|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.28|-0.28|0.986
70931692|NCT01128595|141364122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.484|||||TWO_SIDED|95.0|0.332|0.636||||||||0.636|0.332|
71050891|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.459|TWO_SIDED|95.0|-0.18|0.39|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.39|-0.18|0.459
71050892|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.287|TWO_SIDED|95.0|-0.18|0.62|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.62|-0.18|0.287
71050893|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.6|TWO_SIDED|95.0|-0.3|0.51|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.51|-0.30|0.600
71050894|NCT02912650|141608105|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.447|TWO_SIDED|95.0|-0.17|0.4|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.40|-0.17|0.447
71050895|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59||||0.001|TWO_SIDED|95.0|0.23|0.96|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.96|0.23|0.001
71050896|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.297|TWO_SIDED|95.0|-0.12|0.39|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.39|-0.12|0.297
70931693|NCT01128595|141364122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.484|||||TWO_SIDED|95.0|0.33|0.638||||||||0.638|0.330|
70931694|NCT01128595|141364122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.168|||||TWO_SIDED|95.0|0.009|0.327||||||||0.327|0.009|
70931695|NCT01128595|141364122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.14|0.14||||||||0.140|-0.140|
70931696|NCT01128595|141364122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.316|||||TWO_SIDED|95.0|0.168|0.464||||||||0.464|0.168|
70931697|NCT01128595|141364123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.212|||||TWO_SIDED|95.0|0.031|0.393||||||||0.393|0.031|
70931698|NCT01128595|141364123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.341|||||TWO_SIDED|95.0|0.147|0.536||||||||0.536|0.147|
70931699|NCT01128595|141364123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.477|||||TWO_SIDED|95.0|0.282|0.672||||||||0.672|0.282|
70931700|NCT01128595|141364123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|||||TWO_SIDED|95.0|0.066|0.463||||||||0.463|0.066|
70931701|NCT01128595|141364123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|||||TWO_SIDED|95.0|-0.072|0.343||||||||0.343|-0.072|
70931702|NCT01128595|141364124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|||||TWO_SIDED|95.0|-0.037|0.215||||||||0.215|-0.037|
70931703|NCT01128595|141364124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.236|||||TWO_SIDED|95.0|0.101|0.371||||||||0.371|0.101|
70931704|NCT01128595|141364124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.263|||||TWO_SIDED|95.0|0.127|0.398||||||||0.398|0.127|
71017451|NCT04035694|141541970|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.06||0.63|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.63
71017452|NCT04035694|141541971|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.79|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.79
71017453|NCT04035694|141541972|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.16||0.93|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.93
71050897|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.457|TWO_SIDED|95.0|-0.35|0.16|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.16|-0.35|0.457
71050898|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46||||0.012|TWO_SIDED|95.0|0.1|0.82|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.82|0.10|0.012
71017454|NCT04035694|141541973|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|2.98|STANDARD_ERROR_OF_MEAN|2.18||0.2|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||.20
71050899|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.69|||<|0.001|TWO_SIDED|95.0|0.33|1.06|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.06|0.33|<0.001
70931705|NCT01128595|141364124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|||||TWO_SIDED|95.0|0.036|0.312||||||||0.312|0.036|
70931706|NCT01128595|141364124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026|||||TWO_SIDED|95.0|-0.118|0.171||||||||0.171|-0.118|
70931707|NCT00372775|141364132|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|1.6|||||TWO_SIDED|95.0|0.0|8.8|||||Two-Sided Confidence Interval (CI) from Exact Method using the F Distribution|||8.8|0.0|
71017455|NCT04035694|141541974|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|2.52||0.11|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.11
70931708|NCT00372775|141364134|SUPERIORITY_OR_OTHER||ORR (percent)|4.3|||||TWO_SIDED|95.0|0.1|21.9|||||Two-Sided CI from Exact Method using the F Distribution|||21.9|0.1|
71050900|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.23||||0.076|TWO_SIDED|95.0|-0.49|0.02|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.02|-0.49|0.076
71050901|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|2.03|||<|0.001|TWO_SIDED|95.0|1.42|2.63|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.63|1.42|<0.001
71050902|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51||||0.016|TWO_SIDED|95.0|0.1|0.93|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.93|0.10|0.016
71050903|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.21||||0.33|TWO_SIDED|95.0|-0.21|0.64|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.64|-0.21|0.330
70931709|NCT00372775|141364137|SUPERIORITY_OR_OTHER||Percentage|23.4|||||TWO_SIDED|95.0|14.0|34.3|||||Probability of survival along with the corresponding 2-sided confidence interval for the log \[-log(one-year survival rate)\] calculated using a normal approximation and then back transformed to give a confidence interval for the one-year survival|||34.3|14.0|
70851121|NCT01243242|141190444|SUPERIORITY_OR_OTHER|||||||0.0093||95.0||||p value for the difference between groups in change from Screening to Termination was calculated using the median test for independent samples|Median|||For the primary endpoint (CAARS change), median test was applied as the primary analysis due to outlier numbers observed ; secondary analysis of the primary endpoint utilized ANCOVA with adjustment to age, gender and site (which is usually expected to influence the endpoint) as well as baseline values. Additional parametric T-test was applied, but was found less effective due to outlier values.||||0.0093
71017456|NCT04035694|141541975|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-6.93|STANDARD_ERROR_OF_MEAN|2.38||0.01|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.01
71017457|NCT04035694|141541976|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-2.24|STANDARD_ERROR_OF_MEAN|4.45||0.64|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.64
71017458|NCT04035694|141541977|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-6.46|STANDARD_ERROR_OF_MEAN|2.53||0.03|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.03
71017459|NCT04035694|141541978|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|1.23|STANDARD_ERROR_OF_MEAN|2.68||0.65|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.65
71017460|NCT04035694|141541979|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.65|STANDARD_ERROR_OF_MEAN|0.15|<|0.01|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||<.01
71017461|NCT04035694|141541980|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.22||0.2|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.20
71017462|NCT04035694|141541981|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|2.79|STANDARD_ERROR_OF_MEAN|2.22||0.28|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.28
71017463|NCT04035694|141541982|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Median Difference (Net)|1.56|STANDARD_ERROR_OF_MEAN|2.77||0.58|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.58
71017464|NCT04035694|141541983|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.1||0.49|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.49
71017465|NCT04035694|141541984|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.14||0.55|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||.55
71017466|NCT04035694|141541985|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.09||0.54|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.54
71017467|NCT04035694|141541986|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.1||0.95|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.95
71017468|NCT04035694|141541987|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Median Difference (Net)|-4.25|STANDARD_ERROR_OF_MEAN|2.15||0.05|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.05
71017469|NCT04035694|141541988|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|1.37|STANDARD_ERROR_OF_MEAN|3.84||0.75|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.75
71017470|NCT04035694|141541989|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.09||0.14|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.14
71017471|NCT04035694|141541990|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.08||0.03|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.03
71017472|NCT04035694|141541991|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.06||0.01|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.01
71017473|NCT04035694|141541992|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.08||0.02|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.02
71017474|NCT04035694|141541993|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.06||0.03|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.03
71050904|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|1.51|||<|0.001|TWO_SIDED|95.0|0.91|2.11|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.11|0.91|<0.001
71050905|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|1.81|||<|0.001|TWO_SIDED|95.0|1.21|2.42|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.42|1.21|<0.001
71050906|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.163|TWO_SIDED|95.0|-0.73|0.12|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.12|-0.73|0.163
71017475|NCT04035694|141541994|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.13||0.57|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.57
71017476|NCT04035694|141541995|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.08||0.91|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.91
71017477|NCT04035694|141541996|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.11||0.72|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.72
71017478|NCT04035694|141541997|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.09||0.07|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.07
71017479|NCT04035694|141541998|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.1||0.56|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.56
71017480|NCT04035694|141541999|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.11||0.17|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.17
71017481|NCT04035694|141542000|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.12||0.89|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.89
71017482|NCT04035694|141542001|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.08||0.2|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||.20
71017483|NCT04035694|141542002|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.16||0.78|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.78
71017484|NCT04035694|141542003|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.09||0.41|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.41
71050907|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|3.91|||<|0.001|TWO_SIDED|95.0|3.18|4.65|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.65|3.18|<0.001
71017485|NCT04035694|141542004|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.11||0.34|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.34
71017486|NCT01102972|141542005|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be established between the two arms if the lower limit of the 2-sided 95% confidence interval (CI) for the difference in the percentage of participants with HIV-1 RNA \<50 copies/mL at Week 24 was -12% or greater.|Treatment difference of proportions|0.33||||0.937||95.0|-7.97|8.64||The p-value was obtained from the Cochran-Mantel-Haenszel method stratified by initial antiretroviral regimen.|Cochran-Mantel-Haenszel||95% confidence intervals were calculated (using Mantel-Haenszel weight) stratified by initial antiretroviral regimen.|||8.64|-7.97|0.937
71017487|NCT01856257|141542029|SUPERIORITY||Mean Difference (Final Values)|3.512||||0.544|TWO_SIDED|95.0|-7.999|15.024|||Mixed Models Analysis||The p-value, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from weeks 4, 12, 28, 36, and 52 to compare Group 2 to Group 1.|||15.024|-7.999|0.544
70941617|NCT04748445|141383934|OTHER||Slope|-1.326|STANDARD_ERROR_OF_MEAN|1.174||0.9103|TWO_SIDED|90.0|-2.079|1.814|||Mixed Models Analysis|||EE\_Cepstral Peak Prominence (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-2. For estimated value it was 10\^-3).||1.814|-2.079|0.9103
71017488|NCT01856257|141542029|SUPERIORITY||Mean Difference (Final Values)|4.82||||0.531|TWO_SIDED|95.0|-10.481|20.121|||Mixed Models Analysis||P-value estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from weeks 4, 12, 28, 36, and 52 to compare Group 3 to Group 1.|||20.121|-10.481|0.531
71017489|NCT01125358|141542066|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-2.02|||||TWO_SIDED|90.0|-3.37|0.0|||Multiple Comparisons with The Best (MCB)|LS mean difference = LS mean of 10 mg LY2140023 - LS mean of 80 mg LY2140023.||||0.00|-3.37|
71017490|NCT01125358|141542066|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-1.05|||||TWO_SIDED|90.0|-2.42|0.32|||Multiple Comparison with The Best (MCB)|LS mean difference = LS mean of 160 mg LY2140023 - LS mean of 80 mg LY2140023.||||0.32|-2.42|
71017491|NCT01125358|141542067|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-9.84|STANDARD_ERROR_OF_MEAN|7.96||0.222|TWO_SIDED|95.0|-25.8|6.12||P-value is for PANSS Total Score.|MMRM|||||6.12|-25.80|0.222
71017492|NCT01125358|141542067|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-11.91|STANDARD_ERROR_OF_MEAN|7.22||0.105|TWO_SIDED|95.0|-26.42|2.6||P-value is for PANSS Total Score.|MMRM|||||2.60|-26.42|0.105
71050908|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86||||0.001|TWO_SIDED|95.0|0.35|1.38|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.38|0.35|0.001
71050909|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.78||||0.003|TWO_SIDED|95.0|0.26|1.31|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.31|0.26|0.003
71050910|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|3.05|||<|0.001|TWO_SIDED|95.0|2.32|3.79|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.79|2.32|<0.001
71017493|NCT01125358|141542067|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-7.96|STANDARD_ERROR_OF_MEAN|7.73||0.308|TWO_SIDED|95.0|-23.46|7.55||P-value is for PANSS Total Score.|MMRM|||||7.55|-23.46|0.308
71017494|NCT01125358|141542067|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-1.6|STANDARD_ERROR_OF_MEAN|2.06||0.441|TWO_SIDED|95.0|-5.74|2.54||P-value is for PANSS Positive Subscore.|MMRM|||||2.54|-5.74|0.441
71017495|NCT01125358|141542067|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-4.22|STANDARD_ERROR_OF_MEAN|1.88||0.03||95.0|-8.01|-0.44||P-value is for PANSS Positive Subscore.|MMRM|||||-0.44|-8.01|0.030
71017496|NCT01125358|141542067|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-1.98|STANDARD_ERROR_OF_MEAN|1.98||0.323|TWO_SIDED|95.0|-5.96|2.01||P-value is for PANSS Positive Subscore.|MMRM|||||2.01|-5.96|0.323
71017497|NCT01125358|141542067|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-2.46|STANDARD_ERROR_OF_MEAN|2.28||0.285|TWO_SIDED|95.0|-7.05|2.12||P-value is for PANSS Negative Subscore.|MMRM|||||2.12|-7.05|0.285
71017498|NCT01125358|141542067|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-2.92|STANDARD_ERROR_OF_MEAN|2.07||0.166|TWO_SIDED|95.0|-7.1|1.26||P-value is for PANSS Negative Subscore.|MMRM|||||1.26|-7.10|0.166
71050911|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|3.13|||<|0.001|TWO_SIDED|95.0|2.39|3.87|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.87|2.39|<0.001
71050912|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.769|TWO_SIDED|95.0|-0.6|0.44|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.44|-0.60|0.769
71050913|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|4.65|||<|0.001|TWO_SIDED|95.0|3.88|5.42|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||5.42|3.88|<0.001
71017499|NCT01125358|141542067|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-2.37|STANDARD_ERROR_OF_MEAN|2.2||0.286|TWO_SIDED|95.0|-6.79|2.05||P-value is for PANSS Negative Subscore.|MMRM|||||2.05|-6.79|0.286
71017500|NCT01125358|141542067|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-5.67|STANDARD_ERROR_OF_MEAN|4.14||0.177|TWO_SIDED|95.0|-13.96|2.63||P-value is for PANSS General Psychopathology Subscore.|MMRM|||||2.63|-13.96|0.177
70931710|NCT00336505|141364151|NON_INFERIORITY_OR_EQUIVALENCE|Delta will be determined by the highest clinical cure-rate between the Cethromycin treatment group and the Clarithromycin treatment group, as follows: Greater than or equal to 90%, delta = -10%; Greater than or equal to 80% and less than 90%, delta = -15%, Greater than or equal to 70% and less than 80%, -20%)|Mean Difference (Net)|2.0||||0.5667|TWO_SIDED|95.0|-4.8|8.9|||Fisher Exact|||The rate of clinical cure in each treatment group was calculated (number of cures/number of patient eligible for analysis). Non-inferiority will be demonstrated when the lower limit of the two-sided 95% confidence interval for the difference in the clinical cure rate at the Test-of-Cure visit between treatment groups (Cethromycin -Clarithromycin) is greater than delta, and includes zero, for both Per-Protocol (PP) and Intent-to-Treat (ITT) analyses.||8.9|-4.8|0.5667
70931711|NCT00336505|141364153|NON_INFERIORITY_OR_EQUIVALENCE|Delta will be determined by the highest clinical cure-rate between the Cethromycin treatment group and the Clarithromycin treatment group, as follows: Greater than or equal to 90%, delta = -10%; Greater than or equal to 80% and less than 90%, delta = -15%, Greater than or equal to 70% and less than 80%, -20%)|Mean Difference (Net)|0.3|||>|0.9999||95.0|-4.5|5.1|||Fisher Exact|||The rate of clinical cure in each treatment group was calculated (number of cures/number of patient eligible for analysis). Non-inferiority will be demonstrated when the lower limit of the two-sided 95% confidence interval for the difference in the clinical cure rate at the Test-of-Cure visit between treatment groups (Cethromycin -Clarithromycin) is greater than delta, and includes zero, for both Per-Protocol (PP) and Intent-to-Treat (ITT) analyses.||5.1|-4.5|>0.9999
70931712|NCT01561300|141364155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.09|TWO_SIDED|95.0|-2.16|0.17|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Tea-placebo|Null hypothesis: no difference between Tea and Control.||0.17|-2.16|0.09
70931713|NCT01561300|141364156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.7|TWO_SIDED|95.0|-2.44|1.66|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Tea- Control|Null hypothesis: no difference between Tea and Control.||1.66|-2.44|0.70
70931714|NCT01561300|141364157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.66|TWO_SIDED|95.0|-1.15|0.75||Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Mixed Models Analysis||Tea-placebo|Null hypothesis: no difference between Tea and Control.||0.75|-1.15|0.66
70931715|NCT00724126|141364166|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||Regression, Logistic|The p-value was obtained from a logistic regression model with fixed effects for treatment arm and analysis center.||||||0.03
71017501|NCT01125358|141542067|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-5.1|STANDARD_ERROR_OF_MEAN|3.74||0.178|TWO_SIDED|95.0|-12.6|2.4||P-value is for PANSS General Psychopathology Subscore.|MMRM|||||2.40|-12.60|0.178
71105307|NCT04756531|141717924|OTHER|Natural log transformed AUCinf for PF-07321332 was analyzed using a mixed effect model with sequence, period, and treatment included as fixed effects and subject nested within sequence as a random effect. PF-07321332 250 mg (Tablet), Fasted was the test treatment and PF-07321332 250 mg (Suspension), Fasted was the reference treatment.|Ratio of Adjusted Geometric Means|76.06|||||TWO_SIDED|90.0|60.14|96.2||||||||96.20|60.14|
71105308|NCT04756531|141717925|OTHER|Natural log transformed Cmax for PF-07321332 was analyzed using a mixed effect model with sequence, period, and treatment included as fixed effects and subject nested within sequence as a random effect. PF-07321332 250 mg (Tablet), Fasted was the test treatment and PF-07321332 250 mg (Suspension), Fasted was the reference treatment.|Ratio of Adjusted Geometric Means|56.38|||||TWO_SIDED|90.0|43.42|73.19||||||||73.19|43.42|
71017502|NCT01125358|141542067|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-3.61|STANDARD_ERROR_OF_MEAN|4.05||0.377|TWO_SIDED|95.0|-11.72|4.51||P-value is for PANSS General Psychopathology Subscore.|MMRM|||||4.51|-11.72|0.377
71017503|NCT01125358|141542068|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.87|STANDARD_ERROR_OF_MEAN|0.48||0.077|TWO_SIDED|95.0|-0.1|1.83|||MMRM|||||1.83|-0.10|0.077
71017504|NCT01125358|141542068|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.24|STANDARD_ERROR_OF_MEAN|0.44||0.592|TWO_SIDED|95.0|-1.12|0.65|||MMRM|||||0.65|-1.12|0.592
71017505|NCT01125358|141542068|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.39|STANDARD_ERROR_OF_MEAN|0.46||0.395|TWO_SIDED|95.0|-0.53|1.32|||MMRM|||||1.32|-0.53|0.395
71017506|NCT01125358|141542069|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|4.64|STANDARD_ERROR_OF_MEAN|4.49||0.306|TWO_SIDED|95.0|-4.37|13.65|||MMRM|||||13.65|-4.37|0.306
71017507|NCT01125358|141542069|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.82|STANDARD_ERROR_OF_MEAN|4.26||0.849|TWO_SIDED|95.0|-7.74|9.38|||MMRM|||||9.38|-7.74|0.849
71017508|NCT01125358|141542069|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-5.09|STANDARD_ERROR_OF_MEAN|4.46||0.259||95.0|-14.05|3.86|||MMRM|||||3.86|-14.05|0.259
70931716|NCT00724126|141364167|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Regression, Logistic|The p-value was obtained from a logistic regression model with fixed effects for treatment arm and analysis center.||||||0.02
70931717|NCT02502526|141364171|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<.001
70931718|NCT02502526|141364172|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<.001
70931719|NCT02502526|141364172|SUPERIORITY|||||||0.605|||||||ANCOVA|||||||0.605
70931720|NCT02502526|141364173|SUPERIORITY|||||||0.52|||||||ANCOVA|||||||0.520
70931721|NCT02502526|141364173|SUPERIORITY|||||||0.817|||||||ANCOVA|||||||0.817
70941618|NCT04748445|141383934|OTHER||Slope|0.007667|STANDARD_ERROR_OF_MEAN|1.741||0.6605|TWO_SIDED|90.0|-0.02119|0.03653|||Mixed Models Analysis|||EE\_Harmonicity (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.03653|-0.02119|0.6605
71017509|NCT01125358|141542071|SUPERIORITY_OR_OTHER_LEGACY|||||||0.354||95.0|||||Fisher Exact|||||||0.354
71017510|NCT01125358|141542071|SUPERIORITY_OR_OTHER_LEGACY|||||||0.181||95.0|||||Fisher Exact|||||||0.181
71017511|NCT01125358|141542071|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999||95.0|||||Fisher Exact|||||||>0.999
71017512|NCT00318409|141542079|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.98
70931722|NCT00571649|141364177|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.771||||0.0211||95.0|0.618|0.962||Hochberg procedure: A 2-sided p-value of less than 0.05 would be considered significant, if the 1-sided p-value of the other primary efficacy outcome measure was less than 0.025, elsewise a p-value of less than 0.025 would be considered significant.|Cochran-Mantel-Haenszel|Weighted relative risks were calculated using asymptotic methods, with weights based upon sample sizes per strata (geographic region).||A sample size of 2876 valid patients per group was estimated to obtain a joint power of at least 90% for both primary endpoints (91.4% for superiority) with 4% event rate at day 35 for comparator and 40% relative risk reduction.||0.962|0.618|0.0211
70931723|NCT00571649|141364178|NON_INFERIORITY_OR_EQUIVALENCE|Rivaroxaban would be considered at least as effective as the comparator if the upper limit of the CI (Confidence Interval) was less than 1.5|Risk Ratio (RR)|0.968||||0.0025||95.0|0.713|1.314||Hochberg procedure: A 1-sided p-value of less than 0.025 would be considered significant, if the 2-sided p-value of the other primary efficacy outcome measure was less than 0.05, elsewise a p-value of less than 0.0125 would be considered significant.|Cochran-Mantel-Haenszel|Weighted relative risks were calculated using asymptotic methods, with weights based upon sample sizes per strata (geographic region).||A sample size of 2876 valid patients per group was estimated to obtain a joint power of at least 90% for both primary endpoints (98.6% power for non-inferiority) with 1.8% event rate at day 10 for comparator and 35% relative risk reduction.||1.314|0.713|0.0025
70931724|NCT00571649|141364179|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.931||||0.3758||95.0|0.795|1.091||Test hierarchy: A p-value of less than 0.05 would be considered significant, if the tests for the two primary efficacy outcome measures were significant.|Cochran-Mantel-Haenszel|Weighted relative risks were calculated using asymptotic methods, with weights based upon sample sizes per strata (geographic region).||||1.091|0.795|0.3758
71105309|NCT04756531|141717958|OTHER|Natural log transformed AUClast for PF-07321332 was analyzed using a mixed effect model with sequence, period, and treatment included as fixed effects and subject nested within sequence as a random effect. PF-07321332 250 mg (Tablet), Fed was the test treatment and PF-07321332 250 mg (Tablet), Fasted was the reference treatment.|Ratio of Adjusted Geometric Means|148.91|||||TWO_SIDED|90.0|126.92|174.72||||||||174.72|126.92|
71105310|NCT04756531|141717959|OTHER|Natural log transformed AUCinf for PF-07321332 was analyzed using a mixed effect model with sequence, period, and treatment included as fixed effects and subject nested within sequence as a random effect. PF-07321332 250 mg (Tablet), Fed was the test treatment and PF-07321332 250 mg (Tablet), Fasted was the reference treatment.|Ratio of Adjusted Geometric Means|146.8|||||TWO_SIDED|90.0|118.8|181.41||||||||181.41|118.80|
71105311|NCT04756531|141717960|OTHER|Natural log transformed Cmax for PF-07321332 was analyzed using a mixed effect model with sequence, period, and treatment included as fixed effects and subject nested within sequence as a random effect. PF-07321332 250 mg (Tablet), Fed was the test treatment and PF-07321332 250 mg (Tablet), Fasted was the reference treatment.|Ratio of Adjusted Geometric Means|244.84|||||TWO_SIDED|90.0|188.58|317.87||||||||317.87|188.58|
71017513|NCT00742859|141542091|OTHER||Hazard Ratio (HR)|0.14||||0.035|TWO_SIDED|95.0|0.017|1.14|||Log Rank|||Betrixaban 40mg compared to Warfarin||1.14|0.017|0.035
71017514|NCT00742859|141542091|OTHER||Hazard Ratio (HR)|0.711||||0.546|TWO_SIDED|95.0|0.225|2.24|||Log Rank|||Betrixaban 60mg compared to Warfarin||2.24|0.225|0.546
71017515|NCT00742859|141542091|OTHER||Hazard Ratio (HR)|0.755||||0.712|TWO_SIDED|95.0|0.239|2.39|||Log Rank|||Betrixaban 80mg compared to Warfarin||2.39|0.239|0.712
71017516|NCT00742859|141542092|OTHER||Hazard Ratio (HR)|0.508||||0.011|TWO_SIDED|95.0|0.301|0.856|||Log Rank|||Betrixaban 40mg compared to Warfarin||0.856|0.301|0.011
71017517|NCT00742859|141542092|OTHER||Hazard Ratio (HR)|0.767||||0.308|TWO_SIDED|95.0|0.481|1.22|||Log Rank|||Betrixaban 60mg compared to Warfarin||1.22|0.481|0.308
71017518|NCT00742859|141542092|OTHER||Hazard Ratio (HR)|0.551||||0.022|TWO_SIDED|95.0|0.332|0.914|||Log Rank|||Betrixaban 80mg compared to Warfarin||0.914|0.332|0.022
71017519|NCT00956709|141542096|SUPERIORITY_OR_OTHER|||||||0.56||||||Two patients in each group had incomplete block before sugery.|Wilcoxon (Mann-Whitney)|||||||0.56
71017520|NCT00956709|141542098|SUPERIORITY_OR_OTHER|||||||0.3354|||||||Wilcoxon (Mann-Whitney)|||||||0.3354
71017521|NCT00956709|141542099|SUPERIORITY_OR_OTHER|||||||0.0445|||||||Wilcoxon (Mann-Whitney)|||||||0.0445
71017522|NCT00962013|141542100|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin is 7%||||||0.0136|||||||Exact Binomial|||This revision study will demonstrate a 5-year survivorship of the Restoration Modular system not seven percent worse than an expected 95% survival rate using a lower 95% one-sided confidence bound.||||0.0136
71017523|NCT00962013|141542102|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from HHS pre-op to HHS 5 year||||<0.0001
71017524|NCT00962013|141542103|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from SF-36 Role-Physical pre-op score to 2 and 5 year scores||||<0.0001
71017525|NCT00962013|141542105|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Exact Binomial|||Post-surgery femoral stem crack/fracture rate compared to 21% (pre-specified in protocol based on literature rates) Femoral subsidence rate compared to 18% (pre-specified in protocol based on literature rates)||||<0.0001
71105312|NCT00253422|141718000|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.76|TWO_SIDED|95.0|0.86|1.24|||Log Rank|||||1.24|0.86|0.76
71017526|NCT03706209|141542121|SUPERIORITY||Odds Ratio (OR)|4.12||||0.161|TWO_SIDED|95.0|0.47|35.97|||Cochran-Mantel-Haenszel|||||35.97|0.47|0.161
71017527|NCT03706209|141542121|SUPERIORITY||Odds Ratio (OR)|5.52||||0.111|TWO_SIDED|95.0|0.55|55.43|||Cochran-Mantel-Haenszel|||||55.43|0.55|0.111
71017528|NCT03706209|141542122|SUPERIORITY||Odds Ratio (OR)|1.73||||0.222|TWO_SIDED|95.0|0.71|4.25|||Cochran-Mantel-Haenszel|||||4.25|0.71|0.222
71017529|NCT03706209|141542122|SUPERIORITY||Odds Ratio (OR)|1.91||||0.182|TWO_SIDED|95.0|0.75|4.91|||Cochran-Mantel-Haenszel|||||4.91|0.75|0.182
71017530|NCT03706209|141542123|SUPERIORITY||Odds Ratio (OR)|2.91||||0.294|TWO_SIDED|95.0|0.33|25.39|||Cochran-Mantel-Haenszel|||||25.39|0.33|0.294
71017531|NCT03706209|141542123|SUPERIORITY||Odds Ratio (OR)|4.06||||0.291|TWO_SIDED|95.0|0.31|53.14|||Cochran-Mantel-Haenszel|||||53.14|0.31|0.291
71017532|NCT03706209|141542124|SUPERIORITY||Odds Ratio (OR)|1.31||||0.617|TWO_SIDED|95.0|0.45|3.77|||Cochran-Mantel-Haenszel|||||3.77|0.45|0.617
71017533|NCT03706209|141542124|SUPERIORITY||Odds Ratio (OR)|1.73||||0.319|TWO_SIDED|95.0|0.6|5.0|||Cochran-Mantel-Haenszel|||||5|0.6|0.319
71017534|NCT03706209|141542125|SUPERIORITY||Odds Ratio (OR)|1.5||||0.47|TWO_SIDED|95.0|0.5|4.52|||Cochran-Mantel-Haenszel|||||4.52|0.5|0.47
71105313|NCT00253422|141718000|SUPERIORITY||Hazard Ratio (HR)|1.0||||1|TWO_SIDED|95.0|0.83|1.2|||Log Rank|||||1.20|0.83|1.00
71105314|NCT00253422|141718001|SUPERIORITY|||||||0.99|||||||Chi-squared|||||||0.99
71105315|NCT00253422|141718001|SUPERIORITY|||||||0.12|||||||Chi-squared|||||||0.12
71017535|NCT03706209|141542125|SUPERIORITY||Odds Ratio (OR)|2.44||||0.136|TWO_SIDED|95.0|0.76|7.82|||Cochran-Mantel-Haenszel|||||7.82|0.76|0.136
71017536|NCT03706209|141542126|SUPERIORITY||least square means|0.2|STANDARD_ERROR_OF_MEAN|1.4||0.894|TWO_SIDED|95.0|-2.6|3.0|||ANCOVA|||||3|-2.6|0.894
71017537|NCT03706209|141542126|SUPERIORITY||least square means|-1.1|STANDARD_ERROR_OF_MEAN|1.4||0.456|TWO_SIDED|95.0|-3.8|1.7|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||1.7|-3.8|0.456
71017538|NCT03706209|141542128|SUPERIORITY|||||||0.572|||||||Log Rank|Kaplan-Meier estimate of the median time (day) to reach the PASI 75 criterion was not computed since data were too sparse.||||||0.572
71017539|NCT03706209|141542128|SUPERIORITY|||||||0.4494|||||||Log Rank|Kaplan-Meier estimate of the median time (day) to reach the PASI 75 criterion was not computed since data were too sparse.||||||0.4494
71017540|NCT03706209|141542129|SUPERIORITY|||||||0.7922|||||||Log Rank|Kaplan-Meier estimate of the median time (day) to reach the PASI 50 criterion was not computed since data were too sparse.||||||0.7922
71017541|NCT03706209|141542129|SUPERIORITY|||||||0.1425|||||||Log Rank|Kaplan-Meier estimate of the median time (day) to reach the PASI 50 criterion was not computed since data were too sparse.||||||0.1425
71017542|NCT03706209|141542130|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.992|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.992
71017543|NCT03706209|141542130|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.143|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.143
71017544|NCT03706209|141542133|SUPERIORITY|||||||0.178|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.178
71017545|NCT03706209|141542133|SUPERIORITY||Odds Ratio (OR)|0.63||||0.718|TWO_SIDED|95.0|0.05|7.48|||Cochran-Mantel-Haenszel|||||7.48|0.05|0.718
71017546|NCT03706209|141542134|SUPERIORITY||Odds Ratio (OR)|2.4||||0.474|TWO_SIDED|95.0|0.21|28.05|||Cochran-Mantel-Haenszel|||||28.05|0.21|0.474
71017547|NCT03706209|141542134|SUPERIORITY||Odds Ratio (OR)|1.25||||0.867|TWO_SIDED|95.0|0.08|19.05|||Cochran-Mantel-Haenszel|||||19.05|0.08|0.867
71017548|NCT03706209|141542135|SUPERIORITY||Odds Ratio (OR)|2.2||||0.375|TWO_SIDED|95.0|0.38|12.84|||Cochran-Mantel-Haenszel|||||12.84|0.38|0.375
71017549|NCT03706209|141542135|SUPERIORITY||Odds Ratio (OR)|4.24||||0.116|TWO_SIDED|95.0|0.66|27.08|||Cochran-Mantel-Haenszel|||||27.08|0.66|0.116
71017550|NCT03706209|141542136|SUPERIORITY||Odds Ratio (OR)|0.41||||0.287|TWO_SIDED|95.0|0.08|2.27|||Cochran-Mantel-Haenszel|||||2.27|0.08|0.287
71105316|NCT00253422|141718003|SUPERIORITY|||||||0.33|||||||Chi-squared|||||||0.33
71105317|NCT00253422|141718003|SUPERIORITY|||||||0.94|||||||Chi-squared|||||||0.94
70941619|NCT04748445|141383934|OTHER||Slope|1.268|STANDARD_ERROR_OF_MEAN|2.82|<|0.0001|TWO_SIDED|90.0|0.8012|1.736|||Mixed Models Analysis|||EE\_MFCC mean 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||1.736|0.8012|<.0001
71017551|NCT03706209|141542136|SUPERIORITY||Odds Ratio (OR)|1.85||||0.332|TWO_SIDED|95.0|0.53|6.4|||Cochran-Mantel-Haenszel|||||6.4|0.53|0.332
71017552|NCT03706209|141542137|SUPERIORITY||Odds Ratio (OR)|0.81||||0.719|TWO_SIDED|95.0|0.25|2.63|||Cochran-Mantel-Haenszel|||||2.63|0.25|0.719
71017553|NCT03706209|141542137|SUPERIORITY||Odds Ratio (OR)|1.72||||0.357|TWO_SIDED|95.0|0.55|5.32|||Cochran-Mantel-Haenszel|||||5.32|0.55|0.357
71017554|NCT03706209|141542138|SUPERIORITY||Odds Ratio (OR)|1.75||||0.355|TWO_SIDED|95.0|0.53|5.72|||Cochran-Mantel-Haenszel|||||5.72|0.53|0.355
71017555|NCT03706209|141542138|SUPERIORITY||Odds Ratio (OR)|2.22||||0.198|TWO_SIDED|95.0|0.67|7.37|||Cochran-Mantel-Haenszel|||||7.37|0.67|0.198
71017556|NCT03706209|141542139|SUPERIORITY||least square means|0.3|STANDARD_ERROR_OF_MEAN|1.0||0.757|TWO_SIDED|95.0|-1.7|2.3|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||2.3|-1.7|0.757
71017557|NCT03706209|141542139|SUPERIORITY||least square means|-1.1|STANDARD_ERROR_OF_MEAN|1.0||0.267|TWO_SIDED|95.0|-3.1|0.9|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||0.9|-3.1|0.267
71017558|NCT03706209|141542140|SUPERIORITY||least square means|1.0|STANDARD_ERROR_OF_MEAN|1.2||0.412|TWO_SIDED|95.0|-1.4|3.4|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||3.4|-1.4|0.412
71017559|NCT03706209|141542140|SUPERIORITY||least square means|-1.0|STANDARD_ERROR_OF_MEAN|1.2||0.401|TWO_SIDED|95.0|-3.5|1.4|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||1.4|-3.5|0.401
71017560|NCT03706209|141542141|SUPERIORITY||least square means|0.4|STANDARD_ERROR_OF_MEAN|1.7||0.801|TWO_SIDED|95.0|-3.0|3.9|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||3.9|-3|0.801
71105318|NCT00253422|141718005|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.95|TWO_SIDED|95.0|0.84|1.21|||Log Rank||HR less than 1 favour Faslodex + Arimidex|||1.21|0.84|0.95
71105319|NCT00253422|141718005|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.66|TWO_SIDED|95.0|0.87|1.25|||Log Rank||HR less than 1 favours Faslodex + placebo|||1.25|0.87|0.66
71105320|NCT00253422|141718006|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.91|TWO_SIDED|95.0|0.82|1.19|||Log Rank||HR less than 1 favours Faslodex + Arimidex|||1.19|0.82|0.91
71105321|NCT00253422|141718006|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.31|TWO_SIDED|95.0|0.91|1.32|||Log Rank||HR less than 1 favours Faslodex + Placebo|||1.32|0.91|0.31
71105322|NCT04569084|141718010|SUPERIORITY|||||||0.777|||||||ANCOVA|||||||0.777
71105323|NCT04569084|141718011|SUPERIORITY|||||||0.169|||||||Mixed Model for Repeated Measures (MMRM)|||||||0.169
71050914|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86||||0.002|TWO_SIDED|95.0|0.32|1.4|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.40|0.32|0.002
71050915|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|1.38|||<|0.001|TWO_SIDED|95.0|0.83|1.93|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.93|0.83|<0.001
71050916|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|3.79|||<|0.001|TWO_SIDED|95.0|3.02|4.56|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.56|3.02|<0.001
71050917|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|3.27|||<|0.001|TWO_SIDED|95.0|2.49|4.04|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.04|2.49|<0.001
71050918|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.52||||0.062|TWO_SIDED|95.0|-0.03|1.06|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.06|-0.03|0.062
71050919|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|4.83|||<|0.001|TWO_SIDED|95.0|4.01|5.64|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||5.64|4.01|<0.001
71050920|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.76||||0.009|TWO_SIDED|95.0|0.19|1.33|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.33|0.19|0.009
70931725|NCT00571649|141364180|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.991||||0.9473||95.0|0.753|1.304||"Test hierarchy: A p-value of less than 0.05 would be considered significant, if the tests for the 2 primary efficacy outcomes and for Composite endpoint of VTE (any DVT, non fatal PE) and all-cause mortality up to Day 35 + 6 days were significant."|Cochran-Mantel-Haenszel|Weighted relative risks were calculated using asymptotic methods, with weights based upon sample sizes per strata (geographic region).||||1.304|0.753|0.9473
71017561|NCT03706209|141542141|SUPERIORITY||least square means|0.1|STANDARD_ERROR_OF_MEAN|1.7||0.957|TWO_SIDED|95.0|-3.4|3.3|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||3.3|-3.4|0.957
71017562|NCT03706209|141542145|SUPERIORITY||Odds Ratio (OR)|1.45||||0.45|TWO_SIDED|95.0|0.55|3.8|||Cochran-Mantel-Haenszel|||||3.8|0.55|0.45
71017563|NCT03706209|141542145|SUPERIORITY||Odds Ratio (OR)|1.97||||0.186|TWO_SIDED|95.0|0.74|5.26|||Cochran-Mantel-Haenszel|||||5.26|0.74|0.186
71017564|NCT03706209|141542146|SUPERIORITY||Odds Ratio (OR)|0.94||||0.884|TWO_SIDED|95.0|0.41|2.18|||Cochran-Mantel-Haenszel|||||2.18|0.41|0.884
71017565|NCT03706209|141542146|SUPERIORITY||Odds Ratio (OR)|1.49||||0.384|TWO_SIDED|95.0|0.61|3.64|||Cochran-Mantel-Haenszel|||||3.64|0.61|0.384
71017566|NCT03706209|141542147|SUPERIORITY||Odds Ratio (OR)|1.64||||0.311|TWO_SIDED|95.0|0.63|4.26|||Cochran-Mantel-Haenszel|||||4.26|0.63|0.311
71017567|NCT03706209|141542147|SUPERIORITY||Odds Ratio (OR)|1.21||||0.699|TWO_SIDED|95.0|0.47|3.17|||Cochran-Mantel-Haenszel|||||3.17|0.47|0.699
71017568|NCT03706209|141542148|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.671|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.671
71017569|NCT03706209|141542148|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.183|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.183
71050921|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|1.75|||<|0.001|TWO_SIDED|95.0|1.17|2.33|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.33|1.17|<0.001
71050922|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|4.06|||<|0.001|TWO_SIDED|95.0|3.25|4.88|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.88|3.25|<0.001
71050923|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|3.08|||<|0.001|TWO_SIDED|95.0|2.26|3.9|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.90|2.26|<0.001
71050924|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.98|||<|0.001|TWO_SIDED|95.0|0.41|1.56|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.56|0.41|<0.001
71050925|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|4.67|||<|0.001|TWO_SIDED|95.0|3.82|5.52|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||5.52|3.82|<0.001
71050926|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.78||||0.01|TWO_SIDED|95.0|0.19|1.38|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.38|0.19|0.010
71017570|NCT03706209|141542149|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.542|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.542
71017571|NCT03706209|141542149|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.328|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.328
71017572|NCT03706209|141542150|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.921|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.921
70931726|NCT00571649|141364189|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.455|||<|0.0001|TWO_SIDED|95.0|1.854|3.251||2-sided p-value. No adjustment for multiple testing.|Cochran-Mantel-Haenszel|Weighted relative risks were calculated using asymptotic methods, with weights based upon sample sizes per strata (geographic region).||There was no sample size estimation as this was not planed as confirmatory analysis||3.251|1.854|<0.0001
70931727|NCT00571649|141364190|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.272|||<|0.0001|TWO_SIDED|95.0|1.628|3.171||2-sided p-value. No adjustment for multiple testing.|Cochran-Mantel-Haenszel|||There was no sample size estimation as this was not planed as confirmatory analysis||3.171|1.628|<0.0001
71017573|NCT03706209|141542150|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.488|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.488
71017574|NCT03706209|141542161|SUPERIORITY|||||||0.1193|||||||Fisher Exact|||||||0.1193
71017575|NCT03706209|141542161|SUPERIORITY|||||||0.0054|||||||Fisher Exact|||||||0.0054
71017576|NCT03706209|141542162|SUPERIORITY|||||||0.2439|||||||Fisher Exact|||||||0.2439
71017577|NCT03706209|141542162|SUPERIORITY|||||||0.2461|||||||Fisher Exact|||||||0.2461
71017578|NCT03706209|141542163|SUPERIORITY|||||||0.4395|||||||Fisher Exact|||||||0.4395
71017579|NCT03706209|141542163|SUPERIORITY|||||||0.0593|||||||Fisher Exact|||||||0.0593
71017580|NCT03706209|141542165|SUPERIORITY|||||||0.0507|||||||Fisher Exact|||||||0.0507
71017581|NCT03706209|141542165|SUPERIORITY|||||||0.0005|||||||Fisher Exact|||||||0.0005
71017582|NCT03706209|141542166|SUPERIORITY|||||||0.0504|||||||Fisher Exact|||||||0.0504
71050927|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|2.41|||<|0.001|TWO_SIDED|95.0|1.81|3.01|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.01|1.81|<0.001
70931728|NCT00859781|141364225|SUPERIORITY||proportion difference|0.26||||0.08|TWO_SIDED|95.0|0.008|0.52|||Fisher Exact||Direction = 177Lu-J591 + Ketoconazole proportion free of radiographically evident metastases minus 111ln-J591 + Ketoconazole proportion free of radiographically evident metastases.|||0.52|0.008|0.08
70931729|NCT04057820|141364227|SUPERIORITY||Incidence rate ratio (IRR)|0.55|||<|0.0001|TWO_SIDED|95.0|0.46|0.65|||Mixed Models Analysis|The model adjusted for study design (i.e., fixed time effect and random site effect) and randomization scheme stratification indicator.||||0.65|0.46|<0.0001
71017583|NCT03706209|141542166|SUPERIORITY|||||||0.0013|||||||Fisher Exact|||||||0.0013
71017584|NCT03706209|141542167|SUPERIORITY|||||||0.098|||||||Fisher Exact|||||||0.098
71017585|NCT03706209|141542167|SUPERIORITY|||||||0.0032|||||||Fisher Exact|||||||0.0032
71017586|NCT00728988|141542187|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.9237|TWO_SIDED|95.0|-7.3|9.3|||Chi-squared, Corrected||95% confidence interval for the true difference in the incidence of MACE between the two treatment groups. Difference of incidence = usual care minus atorvastatin.|Total MACE: treatment difference. Null hypothesis = no difference between the incidence rates in the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||9.3|-7.3|0.9237
71017587|NCT00728988|141542187|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-10.7|10.7|||Fisher Exact||Confidence limits were calculated by the exact unconditional inference. Difference of incidence = usual care minus atorvastatin.|Death: treatment difference. Null hypothesis = no difference between the incidence rates in two groups. Fisher's exact test was applied because the expected frequency of events was less than 5.||10.7|-10.7|1.0000
71017588|NCT00728988|141542187|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.9158|TWO_SIDED|95.0|-7.2|9.2|||Chi-squared, Corrected||Difference of incidence = usual care minus atorvastatin.|Myocardial Infarction: treatment difference. Null hypothesis = no difference between the incidence rates in the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||9.2|-7.2|0.9158
71017589|NCT00728988|141542187|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.93||||0.8|TWO_SIDED|95.0|0.5104|1.6846|||Regression, Logistic|||Unadjusted odds ratio and 95% confidence interval calculated by including treatment group as the only covariate in the logistic regression model. Reference group = usual care.||1.6846|0.5104|0.80
70931730|NCT04057820|141364228|SUPERIORITY||Risk Ratio (RR)|0.38|||<|0.0001|TWO_SIDED|95.0|0.3|0.47|||Mixed-effect Poisson w/ robust err var|The model adjusted for study design (i.e., fixed time effect and random site effect) and randomization scheme stratification indicator.||||0.47|0.30|<0.0001
70931731|NCT04057820|141364229|SUPERIORITY||Mean Difference (Final Values)|2.3|||||TWO_SIDED|95.0|-0.4|4.9||||||||4.9|-0.4|
71017590|NCT00728988|141542187|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.96||||0.9|TWO_SIDED|95.0|0.4887|1.8836|||Regression, Logistic|||Adjusted odds ratio: model includes treatment group and potential confounding covariates age, gender, country, non-ST elevation myocardial infarction, LVEF \<=40, and use of beta-blockers, ACE-inhibitors, angiotension receptor blockers, calcium channel antagonists, and diuretics. Reference group = usual care.||1.8836|0.4887|0.90
71017591|NCT00728988|141542187|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8494|TWO_SIDED||||||Log Rank|Survival analysis: Kaplan-Meier log rank test.||MACE-free survival up to Day 30. A censoring variable with a value of 1 denoted that the subject had the event and 0 indicated that the subject was censored. A log-rank test was applied to investigate any differences on the survival distribution function between two treatment groups.||||0.8494
71017592|NCT00728988|141542188|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||1|TWO_SIDED|95.0|-5.6|6.3|||Chi-squared, Corrected||Difference of incidence = atorvastatin minus usual care.|Treatment difference (%). Null hypothesis = no difference between the incidence rates in the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||6.3|-5.6|1.0000
71017593|NCT00728988|141542189|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.7896|TWO_SIDED|95.0|-9.7|6.5|||Chi-squared, Corrected||Difference of incidence = atorvastatin minus usual care .|Treatment difference (%). Null hypothesis = no difference between the incidence rates in the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||6.5|-9.7|0.7896
71017594|NCT00728988|141542190|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.4||||0.631|TWO_SIDED|95.0|-10.1|5.4|||Chi-squared, Corrected|||8 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||5.4|-10.1|0.631
71017595|NCT00728988|141542190|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3||||0.518|TWO_SIDED|95.0|-12.1|5.5|||Chi-squared, Corrected|||24 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||5.5|-12.1|0.518
71050928|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|3.89|||<|0.001|TWO_SIDED|95.0|3.04|4.74|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.74|3.04|<0.001
71050929|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|2.26|||<|0.001|TWO_SIDED|95.0|1.4|3.11|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.11|1.40|<0.001
71050930|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|1.63|||<|0.001|TWO_SIDED|95.0|1.02|2.23|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.23|1.02|<0.001
71050931|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|4.53|||<|0.001|TWO_SIDED|95.0|3.65|5.4|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||5.40|3.65|<0.001
71017596|NCT00728988|141542190|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3||||0.236|TWO_SIDED|95.0|-9.6|12.0|||Fisher Exact|||30 days post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. Fisher's exact test was applied because the expected frequency of biomarker elevation was less than 5.||12.0|-9.6|0.236
71017597|NCT00728988|141542191|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.9||||0.425|TWO_SIDED|95.0|-6.2|15.9|||Chi-squared, Corrected|||8 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||15.9|-6.2|0.425
71017598|NCT00728988|141542191|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.3||||0.392|TWO_SIDED|95.0|-6.1|16.7|||Chi-squared, Corrected|||24 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||16.7|-6.1|0.392
71017599|NCT00728988|141542191|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||1|TWO_SIDED|95.0|-10.7|10.9|||Fisher Exact|||30 days post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. Fisher's exact test was applied because the expected frequency of biomarker elevation was less than 5.||10.9|-10.7|1.000
71017600|NCT00728988|141542192|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.7||||0.529|TWO_SIDED|95.0|-9.6|4.3|||Chi-squared, Corrected|||8 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||4.3|-9.6|0.529
71050932|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.82||||0.009|TWO_SIDED|95.0|0.21|1.43|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.43|0.21|0.009
71050933|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|2.42|||<|0.001|TWO_SIDED|95.0|1.79|3.04|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.04|1.79|<0.001
71017601|NCT00728988|141542192|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.827|TWO_SIDED|95.0|-5.8|3.6|||Chi-squared, Corrected|||24 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||3.6|-5.8|0.827
71050934|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|3.71|||<|0.001|TWO_SIDED|95.0|2.83|4.58|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.58|2.83|<0.001
71050935|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|2.11|||<|0.001|TWO_SIDED|95.0|1.23|2.99|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.99|1.23|<0.001
71050936|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|||<|0.001|TWO_SIDED|95.0|0.97|2.22|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.22|0.97|<0.001
71050937|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|4.27|||<|0.001|TWO_SIDED|95.0|3.37|5.17|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||5.17|3.37|<0.001
71050938|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81||||0.012|TWO_SIDED|95.0|0.18|1.44|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.44|0.18|0.012
71050939|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|2.36|||<|0.001|TWO_SIDED|95.0|1.72|3.0|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.00|1.72|<0.001
71050940|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|3.47|||<|0.001|TWO_SIDED|95.0|2.57|4.36|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.36|2.57|<0.001
70931732|NCT04057820|141364230|SUPERIORITY||Mean Difference (Final Values)|23.0|||||TWO_SIDED|95.0|8.1|37.9||||||||37.9|8.1|
70931733|NCT04057820|141364231|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.37|1.76||||||||1.76|0.37|
70931734|NCT04057820|141364232|SUPERIORITY||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.3|1.0|||Mixed Models Analysis|||||1.0|-0.3|
70931735|NCT04057820|141364233|SUPERIORITY||Risk Ratio (RR)|1.94|||||TWO_SIDED|95.0|0.94|3.99||||||||3.99|0.94|
71017602|NCT00728988|141542192|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7||||0.616|TWO_SIDED|95.0|-10.3|11.5|||Fisher Exact|||30 days post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. Fisher's exact test was applied because the expected frequency of biomarker elevation was less than 5.||11.5|-10.3|0.616
71017603|NCT00728988|141542193|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-29.53||||0.7554|TWO_SIDED|95.0|-215.87|156.81|||ANOVA|||8 hours post-PCI: difference (% change).||156.81|-215.87|0.7554
71017604|NCT00728988|141542193|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|50.58||||0.7436|TWO_SIDED|95.0|-253.42|354.58|||ANOVA|||24 hours post-PCI: difference (% change).||354.58|-253.42|0.7436
71017605|NCT00728988|141542193|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-58.22||||0.4741|TWO_SIDED|95.0|-218.12|101.68|||ANOVA|||30 days post-PCI: difference (% change).||101.68|-218.12|0.4741
71017606|NCT00116207|141542194|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED|||||p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.|ANOVA|||BASELINE||||0.32
71017607|NCT00116207|141542194|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED|||||p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.|ANOVA|||24-MONTH||||0.045
71017608|NCT00116207|141542195|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED|||||p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.|ANOVA|||BASELINE||||0.52
71017609|NCT00116207|141542195|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED|||||p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.|ANOVA|||24 MONTH||||0.82
71017610|NCT00116207|141542196|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED|||||p values were computed using a general linear model adjusted at baseline for age, sex, HbA1c.|ANOVA|||24 MONTH||||0.24
71017611|NCT00116207|141542197|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|||||p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.|ANOVA|||24 MONTH||||0.83
71017612|NCT00111007|141542222|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.906||||0.492|TWO_SIDED|95.0|0.627|1.31|||log rank test|||||1.310|0.627|0.492
71017613|NCT00111007|141542223|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.996||||0.979|TWO_SIDED|95.0|0.744|1.333|||log rank test|||||1.333|0.744|0.979
71017614|NCT00111007|141542224|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.863||||0.331|TWO_SIDED|95.0|0.641|1.162|||log rank test|||||1.162|0.641|0.331
71017615|NCT00111007|141542225|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.398||||0.146|TWO_SIDED|95.0|0.11|1.437|||log rank test|||||1.437|0.110|0.146
71017616|NCT00111007|141542226|SUPERIORITY_OR_OTHER|||||||0.389||95.0|||||Fisher Exact|||||||0.389
71017617|NCT00752895|141542277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.295|TWO_SIDED|||||This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Negative binomial regression|||||||0.295
71017618|NCT00752895|141542278|SUPERIORITY_OR_OTHER_LEGACY|||||||0.82|TWO_SIDED|||||This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Negative binomial regression|||||||0.820
70931736|NCT04057820|141364234|SUPERIORITY||Risk Ratio (RR)|1.68|||||TWO_SIDED|95.0|1.13|2.48||||||||2.48|1.13|
70931737|NCT04057820|141364235|SUPERIORITY||Incidence ratio ratio (IRR)|0.56|||||TWO_SIDED|95.0|0.49|0.64|||Mixed Models Analysis|The model adjusted for study design (i.e., fixed time effect and random site effect) and randomization scheme stratification indicator.||||0.64|0.49|
70931738|NCT04057820|141364237|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|0.71|1.47||||||||1.47|0.71|
71017619|NCT03443973|141542282|SUPERIORITY||Difference in Adjusted mean|-0.19|STANDARD_ERROR_OF_MEAN|0.18||0.2998|TWO_SIDED|95.0|-0.55|0.17|||ANCOVA|||Change from Baseline was calculated based on ANCOVA analysis model which included the following covariates and stratification factors =Treatment + Baseline (BL) + Geographic Region + Disease Stage + AD Medication at BL + Apolipoprotein E, Allele e4 (APOE e4) + Baseline ADAS COG13 + Baseline Alzheimer Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL).||0.17|-0.55|0.2998
71017620|NCT03443973|141542288|SUPERIORITY||Difference in adjusted mean|-1.28|STANDARD_ERROR_OF_MEAN|0.58||0.0273|TWO_SIDED|95.0|-2.41|-0.14|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4||-0.14|-2.41|0.0273
71017621|NCT03443973|141542289|SUPERIORITY||Difference in adjusted mean|0.82|STANDARD_ERROR_OF_MEAN|0.78||0.2918|TWO_SIDED|95.0|-0.7|2.34|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Region + Disease Stage + AD Medication at BL + APOE e4||2.34|-0.70|0.2918
71017622|NCT03443973|141542290|SUPERIORITY||Difference in adjusted mean|-0.86|STANDARD_ERROR_OF_MEAN|0.43||0.0438|TWO_SIDED|95.0|-1.7|-0.02|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||-0.02|-1.70|0.0438
71017623|NCT03443973|141542291|SUPERIORITY||Difference in adjusted mean|0.52|STANDARD_ERROR_OF_MEAN|0.27||0.0566|TWO_SIDED|95.0|-0.01|1.06|||ANCOVA|||Change from Baseline was calculated based on ANCOVA analysis model which included the following covariates and stratification factors =Treatment + Baseline + Geographic Region + Disease Stage + AD Medication at BL + APOE e4.||1.06|-0.01|0.0566
71050941|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|1.91|||<|0.001|TWO_SIDED|95.0|1.0|2.82|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.82|1.00|<0.001
71050942|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|1.55|||<|0.001|TWO_SIDED|95.0|0.92|2.19|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.19|0.92|<0.001
71050943|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|3.68|||<|0.001|TWO_SIDED|95.0|2.76|4.6|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.60|2.76|<0.001
71050944|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63||||0.055|TWO_SIDED|95.0|-0.01|1.27|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.27|-0.01|0.055
71050945|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|2.19|||<|0.001|TWO_SIDED|95.0|1.54|2.84|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.84|1.54|<0.001
71050946|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|3.05|||<|0.001|TWO_SIDED|95.0|2.14|3.97|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.97|2.14|<0.001
71050947|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|1.49||||0.002|TWO_SIDED|95.0|0.57|2.42|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.42|0.57|0.002
71050948|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|1.56|||<|0.001|TWO_SIDED|95.0|0.91|2.21|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.21|0.91|<0.001
71050949|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|3.1|||<|0.001|TWO_SIDED|95.0|2.17|4.03|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.03|2.17|<0.001
71050950|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.65||||0.049|TWO_SIDED|95.0|0.0|1.3|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.30|0.00|0.049
71050951|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|1.93|||<|0.001|TWO_SIDED|95.0|1.27|2.59|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.59|1.27|<0.001
70941620|NCT04748445|141383934|OTHER||Slope|-1.752|STANDARD_ERROR_OF_MEAN|2.127||0.4117|TWO_SIDED|90.0|-5.276|1.773|||Mixed Models Analysis|||EE\_MFCC mean 02 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-1).||1.773|-5.276|0.4117
71050952|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|2.44|||<|0.001|TWO_SIDED|95.0|1.52|3.37|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.37|1.52|<0.001
71050953|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|1.17||||0.015|TWO_SIDED|95.0|0.23|2.1|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.10|0.23|0.015
71050954|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|1.28|||<|0.001|TWO_SIDED|95.0|0.62|1.94|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.94|0.62|<0.001
71050955|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|2.48|||<|0.001|TWO_SIDED|95.0|1.56|3.4|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.40|1.56|<0.001
71050956|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56||||0.087|TWO_SIDED|95.0|-0.08|1.2|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.20|-0.08|0.087
71050957|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|1.47|||<|0.001|TWO_SIDED|95.0|0.82|2.12|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.12|0.82|<0.001
71050958|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|1.92|||<|0.001|TWO_SIDED|95.0|1.0|2.84|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.84|1.00|<0.001
71050959|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|1.01||||0.032|TWO_SIDED|95.0|0.09|1.94|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.94|0.09|0.032
71050960|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.91||||0.006|TWO_SIDED|95.0|0.26|1.56|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.56|0.26|0.006
70931739|NCT02415127|141364250|SUPERIORITY|||||||0.5442||||||From a repeated-measures ANCOVA with fixed effects of treatment, visit, and treatment\*visit with baseline score and investigative site as covariates using an unstructured covariance matrix, testing ACTIMMUNE® vs placebo.|ANCOVA|||The primary and secondary efficacy endpoints were tested in a hierarchical manner. Each endpoint was tested in sequential order and the current endpoint must have shown statistical significance (p \< 0.05) prior to performing testing the next endpoint. The primary endpoint, FARS-mNeuro, was to be tested first, followed by the key secondary endpoint, ADL, followed by the other secondary endpoints, T25FW, FARS-mNeuro responder rate, and FARStot.||||0.5442
70931740|NCT02678689|141364274|SUPERIORITY|The two-sample T-test with unequal variance was conducted at a significance level of 0.05|||||<|0.0001|||||||t-test, unequal variance|||||||< 0.0001
70931741|NCT02678689|141364275|SUPERIORITY||Hazard Ratio (HR)|0.091|||<|0.0001|TWO_SIDED|95.0|0.021|0.393|||Cox Model Wald Test||Hazard ratio is based on Cox proportional hazards model with a factor of study group|||0.393|0.021|<.0001
70931742|NCT02678689|141364276|SUPERIORITY||Hazard Ratio (HR)|0.0||||0.0032|TWO_SIDED|95.0|0.0|0.0|||Cox Model Wald Test||Hazard ratio is based on Cox proportional hazards model with a factor of study group|||0.000|0.000|0.0032
70931743|NCT02678689|141364277|SUPERIORITY||||||<|0.0001|||||||t-test, unequal variance|||||||<.0001
70931744|NCT02678689|141364278|SUPERIORITY||||||<|0.0001|||||||t-test, unequal variance|||||||<.0001
70931745|NCT02678689|141364279|SUPERIORITY||Hazard Ratio (HR)|0.209||||0.0081|TWO_SIDED|95.0|0.059|0.735|||Cox Model Wald Test|The p value is a test that the hazard ratio equal to 1.|"Hazard ratio is based on Cox proportional hazards model with a factor of study group.~Hazard Ratio (HR) 190-203 vs DEM-CHILD."|||0.735|0.059|0.0081
70931746|NCT03160885|141364288|SUPERIORITY|Primary endpoints tested sequentially at a 5% significance level.|Risk Difference (RD)|11.1|||<|0.001|TWO_SIDED|95.0|5.8|16.4||Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.|Cochran-Mantel-Haenszel|Primary endpoints tested sequentially at a 5% significance level.|Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.The null hypothesis of no difference in response rates between tralokinumab and placebo were tested against the 2-sided alternative that there is a difference.||16.4|5.8|<0.001
70931747|NCT03160885|141364289|SUPERIORITY|Primary endpoints tested sequentially at a 5% significance level.|Risk Difference (RD)|21.6|||<|0.001|TWO_SIDED|95.0|15.8|27.3||Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.|Cochran-Mantel-Haenszel|Primary endpoints tested sequentially at a 5% significance level.|Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.The null hypothesis of no difference in response rates between tralokinumab and placebo were tested against the 2-sided alternative that there is a difference.||27.3|15.8|<0.001
71017624|NCT03443973|141542292|SUPERIORITY||Difference in adjusted mean|-1.19|STANDARD_ERROR_OF_MEAN|0.53||0.026|TWO_SIDED|95.0|-2.24|-0.14|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||-0.14|-2.24|0.0260
71017625|NCT03443973|141542293|SUPERIORITY||Difference in adjusted mean|-0.03|STANDARD_ERROR_OF_MEAN|0.28||0.9086|TWO_SIDED|95.0|-0.59|0.52|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||0.52|-0.59|0.9086
70931748|NCT03160885|141364290|SUPERIORITY||Risk Difference (RD)|15.6|||<|0.001|TWO_SIDED|95.0|10.3|20.9||Based on the primary analysis of the primary estimand 'Composite', subjects who received rescue medication prior to Week 16 or have missing data at Week 16 were considered as non-responders'.|Cochran-Mantel-Haenszel|Tested sequentially at a 5% significance level.|Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Reduction of Worst Daily Pruritus NRS weekly average ≥4 at Week 16 was tested after the sequential testing of IGA 0/1 and EASI75 if these tests showed statistical significance||20.9|10.3|<0.001
70931749|NCT03160885|141364291|SUPERIORITY|Multiplicity adjustment using the Holm method.|Difference of least square means|-14.0|||<|0.001|TWO_SIDED|95.0|-18.0|-10.1||Based on the primary analysis of the primary estimand 'hypothetical'. Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included.||-10.1|-18.0|<0.001
70931750|NCT03160885|141364292|SUPERIORITY|Multiplicity adjustment using Holm method.|Difference of least square means|-3.9|||<|0.001|TWO_SIDED|95.0|-5.2|-2.6||Based on the primary analysis of the primary estimand 'hypothetical'. Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included.||-2.6|-5.2|<0.001
70931751|NCT03160885|141364293|SUPERIORITY||Risk Difference (RD)|34.1||||0.004|TWO_SIDED|95.0|13.4|54.9||Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication or were transferred to open-label treatment were considered non-responders.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo"||54.9|13.4|0.004
70941621|NCT04748445|141383934|OTHER||Slope|1.39|STANDARD_ERROR_OF_MEAN|1.262||0.2728|TWO_SIDED|90.0|-7.012|3.482|||Mixed Models Analysis|||EE\_MFCC mean 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-1. For lower limit it was 10\^-2).||3.482|-7.012|0.2728
71017626|NCT03443973|141542294|SUPERIORITY||Difference in adjusted mean|1.41|STANDARD_ERROR_OF_MEAN|0.76||0.0629|TWO_SIDED|95.0|-0.08|2.9|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||2.90|-0.08|0.0629
70931752|NCT03160885|141364293|SUPERIORITY||Risk Difference (RD)|19.9||||0.084|TWO_SIDED|95.0|-1.2|40.9||"Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication or were transferred to open-label treatment were considered non-responders.~P value was considered non-significant"|Cochran-Mantel-Haenszel|This test was not statistically significant and hence next maintenance endpoint in the sequential testing procedure was not evaluated|Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo"||40.9|-1.2|0.084
70931753|NCT03160885|141364294|SUPERIORITY||Risk Difference (RD)|33.7|||<|0.001|TWO_SIDED|95.0|17.3|50.0||Based on the primary analysis of the primary estimand 'composite'. Subjects who received rescue medication or were transferred to open-label treatment are considered non-responders.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo"||50.0|17.3|<0.001
70931754|NCT03160885|141364294|SUPERIORITY||Risk Difference (RD)|30.0||||0.001|TWO_SIDED|95.0|13.7|46.4||Test not evaluated for statistical significance. Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication or were transferred to open-label treatment were considered non-responders.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo"||46.4|13.7|0.001
70931755|NCT03160885|141364297|SUPERIORITY||Risk Difference (RD)|29.3|||<|0.001|TWO_SIDED|95.0|22.5|36.1||"Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|||36.1|22.5|<0.001
70931756|NCT03160885|141364298|SUPERIORITY||Risk Difference (RD)|12.7|||<|0.001|TWO_SIDED|95.0|8.3|17.0||"Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|||17.0|8.3|<0.001
70931757|NCT03160885|141364299|SUPERIORITY||Difference of least square means|-9.9|||<|0.001|TWO_SIDED|95.0|-12.2|-7.5||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change will be imputed as 0.||-7.5|-12.2|<0.001
70931758|NCT03160885|141364300|SUPERIORITY||Risk Difference (RD)|8.0|||<|0.001|TWO_SIDED|95.0|4.4|11.6||"Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication prior to Week 16 or with missing data at Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|||11.6|4.4|<0.001
70931759|NCT03160885|141364301|SUPERIORITY||Risk Difference (RD)|18.9|||<|0.001|TWO_SIDED|95.0|12.8|25.1||"Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication prior to Week 16 or with missing data at Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference stratified by region and disease severity.|||25.1|12.8|<0.001
70931760|NCT03160885|141364302|SUPERIORITY||Difference of least square means|-1.3|||<|0.001|TWO_SIDED|95.0|-1.7|-0.8||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included. In case of no post-baseline assessments before initiation of rescue medication, the Week 1 change will be imputed as 0.||-0.8|-1.7|<0.001
70931761|NCT03160885|141364303|SUPERIORITY||Risk Difference (RD)|20.1|||<|0.001|TWO_SIDED|95.0|13.9|26.2||"Subjects who received rescue medication prior to Week 16 or have missing data at Week 16 were considered as non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|||26.2|13.9|<0.001
70931762|NCT03160885|141364304|SUPERIORITY||Risk Difference (RD)|28.9|||<|0.001|TWO_SIDED|95.0|21.4|36.3||"Subjects who received rescue medication prior to Week 16 or have missing data at Week 16 were considered as non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|||36.3|21.4|<0.001
70931763|NCT02307682|141364333|NON_INFERIORITY|The non-inferiority margin was 4 letters.|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.98||0.0003|TWO_SIDED|95.0|-2.5|1.3||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|||1.3|-2.5|0.0003
71017627|NCT03443973|141542295|SUPERIORITY||Difference in adjusted mean|0.79|STANDARD_ERROR_OF_MEAN|0.66||0.2348|TWO_SIDED|95.0|-0.51|2.09|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||2.09|-0.51|0.2348
71017628|NCT03443973|141542302|SUPERIORITY||Difference in adjusted means|-56.46|STANDARD_ERROR_OF_MEAN|3.976|<|0.0001|TWO_SIDED|95.0|-64.36|-48.56|||Mixed Model for Repeated Measures|||Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Type of Tracer + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||-48.56|-64.36|<.0001
71050961|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|1.75|||<|0.001|TWO_SIDED|95.0|0.85|2.66|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.66|0.85|<0.001
71105324|NCT01400412|141718019|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Two-sided p-value without adjustment for multiple testing, interpreted at the 5% nominal level of significance|Wilcoxon (Mann-Whitney)|Stratified Wilcoxon rank sum test stratified by age (\<30 and \>=30 years)||The null hypothesis is that there is no difference between the two arms in the percent of total hip BMD change from baseline to week 48||||<0.001
71017629|NCT03443973|141542303|SUPERIORITY||Difference in adjusted mean|0.01|STANDARD_ERROR_OF_MEAN|0.023||0.7816|TWO_SIDED|95.0|-0.04|0.05|||Mixed Model for Repeated Measures|||Temporal Composite Region: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.05|-0.04|0.7816
71017630|NCT03443973|141542303|SUPERIORITY||Difference in adjusted means|0.01|STANDARD_ERROR_OF_MEAN|0.018||0.6203|TWO_SIDED|95.0|-0.03|0.05|||Mixed Model for Repeated Measures|||Medial Temporal Composite Region: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.05|-0.03|0.6203
71017631|NCT03443973|141542303|SUPERIORITY||Difference in adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.015||0.7754|TWO_SIDED|95.0|-0.03|0.03|||Mixed Model for Repeated Measures|||Frontal Lobe: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.03|-0.03|0.7754
71017632|NCT03443973|141542303|SUPERIORITY||Difference in adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.026||0.9022|TWO_SIDED|95.0|-0.05|0.05|||Mixed Model for Repeated Measures|||Parietal Lobe: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.05|-0.05|0.9022
71017633|NCT03443973|141542304|SUPERIORITY||Percent Difference in Geometric Mean|-13.2||||0.014|TWO_SIDED|95.0|-22.51|-2.87|||ANCOVA|||||-2.87|-22.51|0.014
71017634|NCT03443973|141542305|SUPERIORITY||Percent Difference in Geometric Mean|-14.4|||<|0.001|TWO_SIDED|95.0|-21.88|-6.21|||ANCOVA|||||-6.21|-21.88|<0.001
71017635|NCT03443973|141542306|SUPERIORITY||Percent Difference in Geometric Mean|-17.8|||<|0.001|TWO_SIDED|95.0|-24.92|-10.11|||ANCOVA|||||-10.11|-24.92|<0.001
71017636|NCT03443973|141542307|SUPERIORITY||Percent Difference in Geometric Mean|-21.0|||<|0.001|TWO_SIDED|95.0|-28.29|-12.97|||ANCOVA|||||-12.97|-28.29|<0.001
71017637|NCT00366678|141542330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis - PT the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥5 EU/mL) threshold was calculated||1.4|-1.4|
71017638|NCT00366678|141542330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.7||||||95.0|-4.8|3.3||||||For Pertussis - PTf the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥26.00 EU/mL) threshold was calculated||3.3|-4.8|
71017639|NCT00366678|141542330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥5 EU/mL) threshold was calculated||1.4|-1.4|
71017640|NCT00366678|141542330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-2.3||||||95.0|-6.4|1.7||||||For Pertussis - FHAf the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥36.00 EU/mL) threshold was calculated||1.7|-6.4|
71017641|NCT00366678|141542330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥7.82 EU/mL) threshold was calculated||1.4|-1.4|
71017642|NCT00366678|141542330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|2.7||||||For Pertussis - PT the difference in percentages between the two groups (13vPnC - 7vPnC) at (5 EU/mL) threshold was calculated||2.7|-1.7|
71050962|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14||||0.669|TWO_SIDED|95.0|-0.49|0.77|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.77|-0.49|0.669
71050963|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.89||||0.007|TWO_SIDED|95.0|0.24|1.53|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.53|0.24|0.007
71050964|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|1.61|||<|0.001|TWO_SIDED|95.0|0.71|2.52|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.52|0.71|<0.001
71050965|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86||||0.063|TWO_SIDED|95.0|-0.05|1.78|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.78|-0.05|0.063
71050966|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.75||||0.022|TWO_SIDED|95.0|0.11|1.39|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.39|0.11|0.022
71105325|NCT05395936|141718078|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
70931764|NCT02307682|141364333|NON_INFERIORITY|The non-inferiority margin was 4 letters.|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|-2.1|1.8||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||1.8|-2.1|<0.0001
70931765|NCT02307682|141364334|NON_INFERIORITY|The non-inferiority margin was 4 letters.|Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.95||0.0001|TWO_SIDED|95.0|-2.4|1.3||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|||1.3|-2.4|0.0001
70931766|NCT02307682|141364334|NON_INFERIORITY|The non-inferiority margin was 4 letters.|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.96|<|0.0001|TWO_SIDED|95.0|-1.9|1.9||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||1.9|-1.9|<0.0001
70931767|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|95.0|-1.4|0.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4||0.9|-1.4|
70931768|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.64|||TWO_SIDED|95.0|-1.4|1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||1.1|-1.4|
70931769|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|95.0|-1.4|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 8||1.2|-1.4|
70931770|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-1.7|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8||1.2|-1.7|
70931771|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-1.8|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12||1.2|-1.8|
70931772|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|95.0|-1.5|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||1.6|-1.5|
70931773|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|95.0|-1.8|1.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 16||1.5|-1.8|
70931774|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|95.0|-1.1|2.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16||2.1|-1.1|
71105326|NCT04043286|141718079|SUPERIORITY||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.18||0.009|TWO_SIDED|95.0|0.1|0.85|||Wilcoxon (Mann-Whitney)|The Shapiro-Wilk test assessed data normality, and paired t-tests or Wilcoxon tests were applied based on normality results.||The null hypothesis was that there would be no significant difference in peri-implant bone levels between implants with definitive abutments delivered at the time of surgery, and those subjected to multiple abutment disconnections and reconnections. Power analysis was performed and showed that a sample size of 38 implants was needed to achieve 80% power to detect a difference between the null proportion of 0.500 at a significance level of 0.05.||0.85|0.10|0.009
70931775|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|95.0|-2.2|1.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 20||1.0|-2.2|
70931776|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|95.0|-2.2|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20||1.2|-2.2|
70931777|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.87|||TWO_SIDED|95.0|-2.1|1.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 24||1.3|-2.1|
70931778|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.88|||TWO_SIDED|95.0|-1.9|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||1.6|-1.9|
71117604|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
71017643|NCT00366678|141542330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|2.1||||||95.0|-1.4|6.8||||||For Pertussis - PTf the difference in percentages between the two groups (13vPnC - 7vPnC) at (17.00 EU/mL) threshold was calculated||6.8|-1.4|
71017644|NCT00366678|141542330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|2.7||||||For Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (5 EU/mL) threshold was calculated||2.7|-1.7|
71017645|NCT00366678|141542330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|2.7||||||For Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (7.82 EU/mL) threshold was calculated||2.7|-1.7|
71017646|NCT00366678|141542330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-3.0||||||95.0|-8.0|2.5||||||For Pertussis - FHAf the difference in percentages between the two groups (13vPnC - 7vPnC) at (75.00 EU/mL) threshold was calculated||2.5|-8.0|
71017647|NCT00366678|141542330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-8.0||||||95.0|-14.9|-1.2||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated||-1.2|-14.9|
71017648|NCT00366678|141542330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated||1.4|-1.4|
71017649|NCT00366678|141542330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|2.7||||||95.0|-3.7|9.2||||||For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated||9.2|-3.7|
71017650|NCT00366678|141542330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.5|1.5||||||For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated||1.5|-1.5|
71017651|NCT00366678|141542330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.8||||||95.0|-3.1|1.8||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated||1.8|-3.1|
71017652|NCT00366678|141542330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|2.7||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated||2.7|-1.7|
71017653|NCT00366678|141542330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-2.3||||||95.0|-5.8|1.8||||||For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated||1.8|-5.8|
71017654|NCT00366678|141542330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|2.7||||||For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated||2.7|-1.7|
71017655|NCT00366678|141542330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-2.3||||||95.0|-7.6|3.0||||||For Polio Type 1 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated||3.0|-7.6|
71017656|NCT00366678|141542330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-4.3||||||95.0|-11.4|2.6||||||For Polio Type 2 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated||2.6|-11.4|
71017657|NCT00366678|141542330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.3||||||95.0|-5.0|4.3||||||For Polio Type 3 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated||4.3|-5.0|
71017658|NCT00366678|141542330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.5||||||95.0|-3.6|3.5||||||For Polio Type 1 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated||3.5|-3.6|
71017659|NCT00366678|141542330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.5||||||95.0|-3.1|3.0||||||For Polio Type 2 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated||3.0|-3.1|
71050967|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|1.22||||0.008|TWO_SIDED|95.0|0.32|2.12|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.12|0.32|0.008
70931779|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.92|||TWO_SIDED|95.0|-1.9|1.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 28||1.7|-1.9|
71050968|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05||||0.876|TWO_SIDED|95.0|-0.58|0.68|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.68|-0.58|0.876
71050969|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.49||||0.134|TWO_SIDED|95.0|-0.15|1.13|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.13|-0.15|0.134
71050970|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|1.17||||0.011|TWO_SIDED|95.0|0.27|2.07|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.07|0.27|0.011
71050971|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73||||0.112|TWO_SIDED|95.0|-0.17|1.64|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.64|-0.17|0.112
71050972|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44||||0.179|TWO_SIDED|95.0|-0.2|1.08|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.08|-0.20|0.179
71050973|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.97||||0.032|TWO_SIDED|95.0|0.09|1.85|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.85|0.09|0.032
71050974|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.85|TWO_SIDED|95.0|-0.56|0.67|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.67|-0.56|0.850
71050975|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.311|TWO_SIDED|95.0|-0.3|0.95|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.95|-0.30|0.311
71050976|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.91||||0.043|TWO_SIDED|95.0|0.03|1.79|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.79|0.03|0.043
71050977|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.64||||0.154||95.0|-0.24|1.53|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.53|-0.24|0.154
71050978|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.26||||0.408|TWO_SIDED|95.0|-0.36|0.89|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.89|-0.36|0.408
71050979|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81||||0.065|TWO_SIDED|95.0|-0.05|1.68|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.68|-0.05|0.065
71050980|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05||||0.862|TWO_SIDED|95.0|-0.66|0.55|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.55|-0.66|0.862
71050981|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29||||0.352|TWO_SIDED|95.0|-0.32|0.9|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.90|-0.32|0.352
71050982|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.87||||0.049|TWO_SIDED|95.0|0.0|1.73|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.73|0.00|0.049
71050983|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.52||||0.239|TWO_SIDED|95.0|-0.35|1.39|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.39|-0.35|0.239
71050984|NCT02912650|141608106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34||||0.27|TWO_SIDED|95.0|-0.27|0.96|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.96|-0.27|0.270
71050985|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.15||||0.031|TWO_SIDED|95.0|0.01|0.28|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.28|0.01|0.031
71050986|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.527|TWO_SIDED|95.0|-0.06|0.12|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.12|-0.06|0.527
71050987|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.386|TWO_SIDED|95.0|-0.14|0.05|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.05|-0.14|0.386
71050988|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12||||0.084|TWO_SIDED|95.0|-0.02|0.25|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.25|-0.02|0.084
71050989|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19||||0.006|TWO_SIDED|95.0|0.06|0.32|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.32|0.06|0.006
71050990|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.135|TWO_SIDED|95.0|-0.17|0.02|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.02|-0.17|0.135
71050991|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.54|||<|0.001|TWO_SIDED|95.0|0.34|0.73|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.73|0.34|<0.001
71050992|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.062|TWO_SIDED|95.0|-0.01|0.27|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.27|-0.01|0.062
71050993|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.977|TWO_SIDED|95.0|-0.14|0.14|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.14|-0.14|0.977
71050994|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|||<|0.001|TWO_SIDED|95.0|0.21|0.6|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.60|0.21|<0.001
71050995|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.53|||<|0.001|TWO_SIDED|95.0|0.34|0.73|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.73|0.34|<0.001
70851122|NCT01243242|141190445|SUPERIORITY_OR_OTHER|||||||0.0195||95.0||||p value for the difference between groups in change from Screening to Termination was calculated using ANCOVA, adjusted for baseline score, gender, site and age|ANCOVA|||Analysis of Covariance (ANCOVA) was applied for comparing the differences in changes from screening/baseline (Visit 1) to termination (Visit 6) and to Visits 3 through 5 in the primary endpoint, CAARS, and secondary endpoint scales, CGI-S, TOVA and AAQoL between the study groups with adjustment to confounders (baseline score, site, age, gender, dose and past exposure to any other ADHD drug).||||0.0195
71050996|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13||||0.069|TWO_SIDED|95.0|-0.27|0.01|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.01|-0.27|0.069
71050997|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|1.14|||<|0.001|TWO_SIDED|95.0|0.9|1.38|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.38|0.90|<0.001
71050998|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29|||<|0.001|TWO_SIDED|95.0|0.12|0.46|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.46|0.12|<0.001
71050999|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.011|TWO_SIDED|95.0|0.05|0.39|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.39|0.05|0.011
71051000|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.85|||<|0.001|TWO_SIDED|95.0|0.61|1.09|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.09|0.61|< 0.001
71051001|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.92|||<|0.001|TWO_SIDED|95.0|0.67|1.16|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.16|0.67|<0.001
71051002|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.427|TWO_SIDED|95.0|-0.24|0.1|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.10|-0.24|0.427
71051003|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|1.36|||<|0.001|TWO_SIDED|95.0|1.11|1.6|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.60|1.11|<0.001
71051004|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27||||0.002|TWO_SIDED|95.0|0.1|0.44|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.44|0.10|0.002
71051005|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|||<|0.001|TWO_SIDED|95.0|0.23|0.58|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.58|0.23|<0.001
71051006|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|||<|0.001|TWO_SIDED|95.0|0.84|1.33|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.33|0.84|<0.001
71051007|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.95|||<|0.001|TWO_SIDED|95.0|0.7|1.2|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.20|0.70|<0.001
71051008|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14||||0.123|TWO_SIDED|95.0|-0.04|0.31|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.31|-0.04|0.123
70851123|NCT01243242|141190446|SUPERIORITY_OR_OTHER|||||||0.0093||95.0||||p value for the difference between groups in change from Screening to Termination was calculated using ANCOVA, adjusted for baseline score, gender, site and age.|ANCOVA|||Analysis of covariance (ANCOVA) was applied for comparing the differences in changes from screening/baseline (Visit 1) to termination (Visit 6) between the study groups with adjustment to confounders (baseline score, site, age, gender, dose and past exposure to any other ADHD drug).||||0.0093
71017660|NCT00366678|141542330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.8||||||95.0|-3.1|1.9||||||For Polio Type 3 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated||1.9|-3.1|
71017661|NCT00366678|141542330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.9||||||95.0|-3.2|5.0||||||For Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 (μg/mL) threshold was calculated||5.0|-3.2|
71017662|NCT00366678|141542330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-4.5||||||95.0|-13.2|4.4||||||For Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 (μg/mL) threshold was calculated||4.4|-13.2|
71017663|NCT00366678|141542330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|2.8||||||For Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 (μg/mL) threshold was calculated||2.8|-1.7|
71051009|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|||<|0.001|TWO_SIDED|95.0|1.14|1.67|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.67|1.14|<0.001
71051010|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24||||0.012|TWO_SIDED|95.0|0.05|0.42|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.42|0.05|0.012
71051011|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56|||<|0.001|TWO_SIDED|95.0|0.38|0.75|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.75|0.38|<0.001
71051012|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|1.17|||<|0.001|TWO_SIDED|95.0|0.9|1.43|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.43|0.90|<0.001
71017664|NCT00366678|141542330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.2||||||95.0|-3.1|4.5||||||For Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 (μg/mL) threshold was calculated||4.5|-3.1|
71017665|NCT00366678|141542331|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-1.7|2.9||||||For serotype 4 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.9|-1.7|
71017666|NCT00366678|141542331|SUPERIORITY_OR_OTHER||Difference|0.9||||||95.0|-0.9|4.9||||||For serotype 4 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||4.9|-0.9|
71017667|NCT00366678|141542331|SUPERIORITY_OR_OTHER||Difference|-0.9||||||95.0|-4.9|2.1||||||For serotype 4 the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.1|-4.9|
71017668|NCT00366678|141542331|SUPERIORITY_OR_OTHER||Difference|0.4||||||95.0|-1.8|3.8||||||For serotype 6B the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||3.8|-1.8|
71017669|NCT00366678|141542331|SUPERIORITY_OR_OTHER||Difference|1.4||||||95.0|-1.1|5.9||||||For serotype 6B the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||5.9|-1.1|
71017670|NCT00366678|141542331|SUPERIORITY_OR_OTHER||Difference|-1.1||||||95.0|-5.8|2.7||||||For serotype 6B the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.7|-5.8|
71017671|NCT00366678|141542331|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-1.7|2.9||||||For serotype 9V the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.9|-1.7|
71017672|NCT00366678|141542331|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-1.8|3.3||||||For serotype 9V the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||3.3|-1.8|
71017673|NCT00366678|141542331|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-3.3|3.0||||||For serotype 9V the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||3.0|-3.3|
71051013|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.84|||<|0.001|TWO_SIDED|95.0|0.57|1.11|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.11|0.57|<0.001
71051014|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|||<|0.001|TWO_SIDED|95.0|0.14|0.51|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.51|0.14|<0.001
71051015|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|1.38|||<|0.001|TWO_SIDED|95.0|1.11|1.65|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.65|1.11|<0.001
71051016|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.002|TWO_SIDED|95.0|0.11|0.48|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.48|0.11|0.002
71051017|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.76|||<|0.001|TWO_SIDED|95.0|0.56|0.95|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.95|0.56|<0.001
71051018|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|||<|0.001|TWO_SIDED|95.0|0.82|1.36|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.36|0.82|<0.001
71051019|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63|||<|0.001|TWO_SIDED|95.0|0.35|0.9|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.90|0.35|<0.001
70931780|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.92|||TWO_SIDED|95.0|-1.4|2.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28||2.2|-1.4|
71017674|NCT00366678|141542331|SUPERIORITY_OR_OTHER||Difference|-0.4||||||95.0|-2.5|2.4||||||For serotype 14 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.4|-2.5|
71017675|NCT00366678|141542331|SUPERIORITY_OR_OTHER||Difference|0.5||||||95.0|-1.8|4.4||||||For serotype 14 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||4.4|-1.8|
71017676|NCT00366678|141542331|SUPERIORITY_OR_OTHER||Difference|-0.9||||||95.0|-4.9|2.1||||||For serotype 14 the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.1|-4.9|
71017677|NCT00366678|141542331|SUPERIORITY_OR_OTHER||Difference|0.4||||||95.0|-1.8|3.8||||||For serotype 18C the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||3.8|-1.8|
71017678|NCT00366678|141542331|SUPERIORITY_OR_OTHER||Difference|1.3||||||95.0|-1.1|5.7||||||For serotype 18C the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||5.7|-1.1|
71017679|NCT00366678|141542331|SUPERIORITY_OR_OTHER||Difference|-1.0||||||95.0|-5.5|2.8||||||For serotype 18C the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.8|-5.5|
71017680|NCT00366678|141542331|SUPERIORITY_OR_OTHER||Difference|0.2||||||95.0|-3.1|4.7||||||For serotype 19F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||4.7|-3.1|
71017681|NCT00366678|141542331|SUPERIORITY_OR_OTHER||Difference|0.5||||||95.0|-2.9|5.4||||||For serotype 19F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||5.4|-2.9|
71017682|NCT00366678|141542331|SUPERIORITY_OR_OTHER||Difference|-0.3||||||95.0|-5.5|4.4||||||For serotype 19F the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||4.4|-5.5|
71017683|NCT00366678|141542331|SUPERIORITY_OR_OTHER||Difference|0.4||||||95.0|-1.8|3.9||||||For serotype 23F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||3.9|-1.8|
71017684|NCT00366678|141542331|SUPERIORITY_OR_OTHER||Difference|0.5||||||95.0|-1.9|4.4||||||For serotype 23F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||4.4|-1.9|
71017685|NCT00366678|141542331|SUPERIORITY_OR_OTHER||Difference|-0.1||||||95.0|-4.1|3.7||||||For serotype 23F the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||3.7|-4.1|
71017686|NCT00366678|141542332|SUPERIORITY_OR_OTHER||Ratio|0.87||||||95.0|0.73|1.03||||||For serotype 4 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.03|0.73|
71017687|NCT00366678|141542332|SUPERIORITY_OR_OTHER||Ratio|0.83||||||95.0|0.67|1.03||||||For serotype 4 after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.03|0.67|
71017688|NCT00366678|141542332|SUPERIORITY_OR_OTHER||Ratio|1.04||||||95.0|0.86|1.26||||||For serotype 4 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.26|0.86|
71017689|NCT00366678|141542332|SUPERIORITY_OR_OTHER||Ratio|0.93||||||95.0|0.77|1.13||||||For serotype 6B after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.13|0.77|
71017690|NCT00366678|141542332|SUPERIORITY_OR_OTHER||Ratio|1.07||||||95.0|0.82|1.4||||||For serotype 6B after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.40|0.82|
71017691|NCT00366678|141542332|SUPERIORITY_OR_OTHER||Ratio|0.87||||||95.0|0.69|1.1||||||For serotype 6B after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.10|0.69|
71017692|NCT00366678|141542332|SUPERIORITY_OR_OTHER||Ratio|0.8||||||95.0|0.68|0.94||||||For serotype 9V after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||0.94|0.68|
71017693|NCT00366678|141542332|SUPERIORITY_OR_OTHER||Ratio|0.71||||||95.0|0.59|0.85||||||For serotype 9V after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||0.85|0.59|
71051020|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46|||<|0.001|TWO_SIDED|95.0|0.27|0.65|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.65|0.27|<0.001
71051021|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|1.34|||<|0.001|TWO_SIDED|95.0|1.06|1.61|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.61|1.06|<0.001
70931781|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|95.0|-2.4|1.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 32||1.3|-2.4|
71051022|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.003|TWO_SIDED|95.0|0.1|0.49|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.49|0.10|0.003
71051023|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.78|||<|0.001|TWO_SIDED|95.0|0.58|0.98|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.98|0.58|<0.001
71051024|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|1.04|||<|0.001|TWO_SIDED|95.0|0.76|1.32|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.32|0.76|<0.001
71051025|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56|||<|0.001|TWO_SIDED|95.0|0.28|0.84|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.84|0.28|<0.001
71051026|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48|||<|0.001|TWO_SIDED|95.0|0.29|0.68|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.68|0.29|<0.001
71051027|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|1.28|||<|0.001|TWO_SIDED|95.0|1.0|1.57|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.57|1.00|<0.001
71051028|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.003|TWO_SIDED|95.0|0.1|0.5|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.50|0.10|0.003
71051029|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.71|||<|0.001|TWO_SIDED|95.0|0.51|0.91|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.91|0.51|<0.001
71051030|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.98|||<|0.001|TWO_SIDED|95.0|0.7|1.27|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.27|0.70|<0.001
71051031|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.58|||<|0.001|TWO_SIDED|95.0|0.29|0.86|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.86|0.29|<0.001
71051032|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|||<|0.001|TWO_SIDED|95.0|0.21|0.61|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.61|0.21|<0.001
71051033|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|||<|0.001|TWO_SIDED|95.0|0.81|1.38|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.38|0.81|<0.001
70931782|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|95.0|-1.2|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32||2.5|-1.2|
71051034|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.014|TWO_SIDED|95.0|0.05|0.45|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.45|0.05|0.014
71051035|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.66|||<|0.001|TWO_SIDED|95.0|0.45|0.86|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.86|0.45|<0.001
71051036|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.85|||<|0.001|TWO_SIDED|95.0|0.56|1.13|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.13|0.56|<0.001
71051037|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44||||0.003|TWO_SIDED|95.0|0.15|0.73|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.73|0.15|0.003
71051038|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|||<|0.001|TWO_SIDED|95.0|0.21|0.61|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.61|0.21|<0.001
71051039|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.91|||<|0.001|TWO_SIDED|95.0|0.62|1.2|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.20|0.62|<0.001
71051040|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.21||||0.041|TWO_SIDED|95.0|0.01|0.42|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.42|0.01|0.041
71051041|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56|||<|0.001|TWO_SIDED|95.0|0.35|0.76|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.76|0.35|<0.001
71051042|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.41|0.99|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.99|0.41|<0.001
71051043|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.35||||0.018|TWO_SIDED|95.0|0.06|0.65|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.65|0.06|0.018
71017694|NCT00366678|141542332|SUPERIORITY_OR_OTHER||Ratio|1.13||||||95.0|0.95|1.33||||||For serotype 9V after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.33|0.95|
71017695|NCT00366678|141542332|SUPERIORITY_OR_OTHER||Ratio|0.88||||||95.0|0.73|1.06||||||For serotype 14 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.06|0.73|
71017696|NCT00366678|141542332|SUPERIORITY_OR_OTHER||Ratio|0.72||||||95.0|0.58|0.9||||||For serotype 14 after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||0.90|0.58|
71017697|NCT00366678|141542332|SUPERIORITY_OR_OTHER||Ratio|1.22||||||95.0|1.0|1.49||||||For serotype 14 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.49|1.00|
71017698|NCT00366678|141542332|SUPERIORITY_OR_OTHER||Ratio|0.82||||||95.0|0.69|0.97||||||For serotype 18C after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||0.97|0.69|
71017699|NCT00366678|141542332|SUPERIORITY_OR_OTHER||Ratio|0.86||||||95.0|0.69|1.08||||||For serotype 18C after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.08|0.69|
71017700|NCT00366678|141542332|SUPERIORITY_OR_OTHER||Ratio|0.95||||||95.0|0.78|1.15||||||For serotype 18C after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.15|0.78|
71017701|NCT00366678|141542332|SUPERIORITY_OR_OTHER||Ratio|1.26||||||95.0|1.0|1.59||||||For serotype 19F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.59|1.00|
71017702|NCT00366678|141542332|SUPERIORITY_OR_OTHER||Ratio|0.91||||||95.0|0.68|1.2||||||For serotype 19F after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.20|0.68|
71017703|NCT00366678|141542332|SUPERIORITY_OR_OTHER||Ratio|1.39||||||95.0|1.08|1.79||||||For serotype 19F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.79|1.08|
71017704|NCT00366678|141542332|SUPERIORITY_OR_OTHER||Ratio|0.81||||||95.0|0.67|1.0||||||For serotype 23F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.00|0.67|
71051044|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34||||0.001|TWO_SIDED|95.0|0.14|0.55|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.55|0.14|0.001
71051045|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.76|||<|0.001|TWO_SIDED|95.0|0.48|1.05|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.05|0.48|<0.001
71051046|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.045|TWO_SIDED|95.0|0.0|0.4|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.40|0.00|0.045
71051047|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44|||<|0.001|TWO_SIDED|95.0|0.24|0.64|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.64|0.24|<0.001
71051048|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56|||<|0.001|TWO_SIDED|95.0|0.28|0.84|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.84|0.28|< 0.001
71051049|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.027|TWO_SIDED|95.0|0.04|0.61|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.61|0.04|0.027
71017705|NCT00366678|141542332|SUPERIORITY_OR_OTHER||Ratio|0.85||||||95.0|0.67|1.07||||||For serotype 23F after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.07|0.67|
71017706|NCT00366678|141542332|SUPERIORITY_OR_OTHER||Ratio|0.96||||||95.0|0.78|1.19||||||For serotype 23F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.19|0.78|
71017707|NCT00366678|141542335|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.77||||||95.0|0.66|0.9||||||For Diphtheria the GMC ratio was calculated||0.90|0.66|
71017708|NCT00366678|141542335|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.94||||||95.0|0.82|1.08||||||For Tetanus the GMC ratio was calculated||1.08|0.82|
71051050|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24||||0.02|TWO_SIDED|95.0|0.04|0.44|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.44|0.04|0.020
71051051|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57|||<|0.001|TWO_SIDED|95.0|0.29|0.85|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.85|0.29|<0.001
71051052|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.374|TWO_SIDED|95.0|-0.11|0.28|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.28|-0.11|0.374
71051053|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34|||<|0.001|TWO_SIDED|95.0|0.14|0.54|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.54|0.14|<0.001
71051054|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48|||<|0.001|TWO_SIDED|95.0|0.2|0.76|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.76|0.20|<0.001
70931783|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|95.0|-2.9|0.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 36||0.8|-2.9|
71051055|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.106|TWO_SIDED|95.0|-0.05|0.51|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.51|-0.05|0.106
70931784|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.95|||TWO_SIDED|95.0|-2.1|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36||1.6|-2.1|
71051056|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.013|TWO_SIDED|95.0|0.05|0.45|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.45|0.05|0.013
71051057|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39||||0.006|TWO_SIDED|95.0|0.11|0.67|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.67|0.11|0.006
71051058|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.796|TWO_SIDED|95.0|-0.17|0.22|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.22|-0.17|0.796
71051059|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.16||||0.104|TWO_SIDED|95.0|-0.03|0.36|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.36|-0.03|0.104
71051060|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.01|TWO_SIDED|95.0|0.09|0.65|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.65|0.09|0.010
71051061|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.114|TWO_SIDED|95.0|-0.05|0.51|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.51|-0.05|0.114
71051062|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14||||0.168|TWO_SIDED|95.0|-0.06|0.34|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.34|-0.06|0.168
71051063|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.022|TWO_SIDED|95.0|0.05|0.59|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.59|0.05|0.022
70931785|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|95.0|-2.2|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 40||1.6|-2.2|
71017709|NCT00366678|141542335|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.8||||||95.0|0.67|0.97||||||For Diphtheria the GMC ratio was calculated||0.97|0.67|
71017710|NCT00366678|141542335|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.86||||||95.0|0.69|1.08||||||For Tetanus the GMC ratio was calculated||1.08|0.69|
71017711|NCT00366678|141542336|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.91||||||95.0|0.73|1.14||||||For Hib (PRP) the GMC ratio was calculated||1.14|0.73|
71017712|NCT00366678|141542336|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.04||||||95.0|0.82|1.32||||||For Hib (PRP) the GMC ratio was calculated||1.32|0.82|
71051064|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05||||0.62|TWO_SIDED|95.0|-0.14|0.24|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.24|-0.14|0.620
71051065|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14||||0.164|TWO_SIDED|95.0|-0.06|0.33|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.33|-0.06|0.164
71051066|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27||||0.052|TWO_SIDED|95.0|0.0|0.54|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.54|-0.00|0.052
71051067|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.196|TWO_SIDED|95.0|-0.09|0.45|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.45|-0.09|0.196
71051068|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.364|TWO_SIDED|95.0|-0.1|0.28|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.28|-0.10|0.364
71051069|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.071|TWO_SIDED|95.0|-0.02|0.52|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.52|-0.02|0.071
71051070|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.865||95.0|-0.2|0.17|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.17|-0.20|0.865
71051071|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.238|TWO_SIDED|95.0|-0.08|0.3|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.30|-0.08|0.238
71051072|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.26||||0.054|TWO_SIDED|95.0|0.0|0.53|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.53|-0.00|0.054
70931786|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-1.9|2.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40||2.1|-1.9|
71051073|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.335|TWO_SIDED|95.0|-0.14|0.4|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.40|-0.14|0.335
71051074|NCT02912650|141608107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.176|TWO_SIDED|95.0|-0.06|0.32|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.32|-0.06|0.176
71051075|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48||||0.002|TWO_SIDED|95.0|0.18|0.77|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.77|0.18|0.002
70931787|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-2.1|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 44||1.9|-2.1|
70931788|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-1.8|2.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44||2.2|-1.8|
70931789|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|95.0|-2.5|1.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 48||1.3|-2.5|
70931790|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-2.1|1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||1.8|-2.1|
71051076|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.098|TWO_SIDED|95.0|-0.03|0.38|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.38|-0.03|0.098
71051077|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.719|TWO_SIDED|95.0|-0.25|0.17|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.17|-0.25|0.719
71051078|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.048|TWO_SIDED|95.0|0.0|0.6|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.60|0.00|0.048
71051079|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51|||<|0.001|TWO_SIDED|95.0|0.21|0.81|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.81|0.21|<0.001
71051080|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21||||0.046|TWO_SIDED|95.0|-0.42|0.0|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||-0.00|-0.42|0.046
71051081|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|1.52|||<|0.001|TWO_SIDED|95.0|1.05|1.99|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.99|1.05|<0.001
70931791|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-2.2|1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 52||1.8|-2.2|
71051082|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.069|TWO_SIDED|95.0|-0.02|0.63|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.63|-0.02|0.069
70931792|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|95.0|-2.2|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52||1.9|-2.2|
71051083|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.604|TWO_SIDED|95.0|-0.24|0.42|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.42|-0.24|0.604
71051084|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|1.22|||<|0.001|TWO_SIDED|95.0|0.75|1.69|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.69|0.75|<0.001
71051085|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|1.43|||<|0.001|TWO_SIDED|95.0|0.96|1.9|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.90|0.96|<0.001
71051086|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22||||0.2|TWO_SIDED|95.0|-0.54|0.11|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.11|-0.54|0.200
71051087|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|2.89|||<|0.001|TWO_SIDED|95.0|2.32|3.46|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.46|2.32|<0.001
71051088|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63||||0.002|TWO_SIDED|95.0|0.23|1.03|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.03|0.23|0.002
71051089|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.55||||0.008|TWO_SIDED|95.0|0.14|0.95|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.95|0.14|0.008
70931793|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-2.5|1.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 56||1.5|-2.5|
70931794|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-2.7|1.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56||1.4|-2.7|
70931795|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-2.1|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 60||1.9|-2.1|
71051090|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|2.26|||<|0.001|TWO_SIDED|95.0|1.69|2.83|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.83|1.69|<0.001
71051091|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|2.34|||<|0.001|TWO_SIDED|95.0|1.77|2.91|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.91|1.77|<0.001
71051092|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.685|TWO_SIDED|95.0|-0.49|0.32|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.32|-0.49|0.685
71051093|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|3.35|||<|0.001|TWO_SIDED|95.0|2.77|3.93|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.93|2.77|<0.001
71051094|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.66||||0.001|TWO_SIDED|95.0|0.26|1.07|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.07|0.26|0.001
71051095|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.98|||<|0.001|TWO_SIDED|95.0|0.57|1.39|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.39|0.57|<0.001
71051096|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|2.69|||<|0.001|TWO_SIDED|95.0|2.11|3.27|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.27|2.11|<0.001
71051097|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|2.37|||<|0.001|TWO_SIDED|95.0|1.79|2.96|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.96|1.79|<0.001
71051098|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.132|TWO_SIDED|95.0|-0.1|0.73|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.73|-0.10|0.132
71051099|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5|||<|0.001|TWO_SIDED|95.0|2.88|4.13|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.13|2.88|<0.001
71051100|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61||||0.007|TWO_SIDED|95.0|0.17|1.05|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.05|0.17|0.007
71051101|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|1.35|||<|0.001|TWO_SIDED|95.0|0.91|1.8|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.80|0.91|<0.001
71051102|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|||<|0.001|TWO_SIDED|95.0|2.27|3.52|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.52|2.27|<0.001
71051103|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|2.15|||<|0.001|TWO_SIDED|95.0|1.52|2.79|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.79|1.52|<0.001
71051104|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.74||||0.001|TWO_SIDED|95.0|0.3|1.19|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.19|0.30|0.001
71051105|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|3.44|||<|0.001|TWO_SIDED|95.0|2.79|4.09|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.09|2.79|<0.001
71051106|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.003|TWO_SIDED|95.0|0.24|1.15|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.15|0.24|0.003
71051107|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|1.85|||<|0.001|TWO_SIDED|95.0|1.39|2.31|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.31|1.39|<0.001
71051108|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|2.74|||<|0.001|TWO_SIDED|95.0|2.1|3.39|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.39|2.10|<0.001
71051109|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|1.59|||<|0.001|TWO_SIDED|95.0|0.94|2.24|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.24|0.94|< 0.001
71051110|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|1.15|||<|0.001|TWO_SIDED|95.0|0.69|1.61|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.61|0.69|<0.001
71051111|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|3.33|||<|0.001|TWO_SIDED|95.0|2.67|4.0|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.00|2.67|<0.001
71051112|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.74||||0.002|TWO_SIDED|95.0|0.27|1.2|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.20|0.27|0.002
70931796|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|95.0|-2.2|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60||1.9|-2.2|
70931797|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|95.0|-2.3|1.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 64||1.7|-2.3|
70931798|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.05|||TWO_SIDED|95.0|-2.2|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64||1.9|-2.2|
70931799|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|95.0|-2.1|2.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 68||2.0|-2.1|
70931800|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.05|||TWO_SIDED|95.0|-2.2|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68||1.9|-2.2|
71051113|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|1.94|||<|0.001|TWO_SIDED|95.0|1.47|2.41|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.41|1.47|<0.001
71051114|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6|||<|0.001|TWO_SIDED|95.0|1.93|3.26|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.26|1.93|<0.001
71105327|NCT04043286|141718080|SUPERIORITY||Mean Difference (Final Values)|0.75|STANDARD_ERROR_OF_MEAN|0.23||0.049|TWO_SIDED|95.0|-0.0000168|1.25|||Wilcoxon (Mann-Whitney)|||"The null hypothesis was that there would be no significant difference in peri-implant bone levels between implants with definitive abutments delivered at the time of surgery, and those subjected to multiple abutment disconnections and reconnections. Power analysis was performed and showed that a sample size of 38 implants was needed to achieve 80% power to detect a difference between the null proportion of 0.500 at a significance level of 0.05.~Type of Statistical Test"||1.25|-0.0000168|0.049
71051115|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|||<|0.001|TWO_SIDED|95.0|0.73|2.07|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.07|0.73|<0.001
71051116|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2|||<|0.001|TWO_SIDED|95.0|0.73|1.67|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.67|0.73|<0.001
71051117|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|3.19|||<|0.001|TWO_SIDED|95.0|2.51|3.87|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.87|2.51|<0.001
70931801|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|1.08|||TWO_SIDED|95.0|-2.0|2.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 72||2.3|-2.0|
70931802|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|95.0|-2.4|1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||1.8|-2.4|
70931803|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|95.0|-1.8|2.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 76||2.4|-1.8|
70931804|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|95.0|-2.1|2.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76||2.1|-2.1|
70931805|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|95.0|-1.5|2.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 80||2.7|-1.5|
71051118|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.76||||0.002|TWO_SIDED|95.0|0.29|1.23|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.23|0.29|0.002
71051119|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|1.85|||<|0.001|TWO_SIDED|95.0|1.37|2.33|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.33|1.37|< 0.001
71051120|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|2.43|||<|0.001|TWO_SIDED|95.0|1.75|3.11|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.11|1.75|<0.001
71051121|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|1.34|||<|0.001|TWO_SIDED|95.0|0.66|2.03|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.03|0.66|<0.001
71017713|NCT00366678|141542337|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.88||||||95.0|0.71|1.09||||||For Polio Type 1 the GMC ratio was calculated||1.09|0.71|
71017714|NCT00366678|141542337|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.82||||||95.0|0.66|1.03||||||For Polio Type 2 the GMC ratio was calculated||1.03|0.66|
71017715|NCT00366678|141542337|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.78||||||95.0|0.59|1.02||||||For Polio Type 3 the GMC ratio was calculated||1.02|0.59|
71017716|NCT00366678|141542337|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.01||||||95.0|0.72|1.41||||||For Polio Type 1 the GMC ratio was calculated||1.41|0.72|
71017717|NCT00366678|141542337|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.98||||||95.0|0.72|1.34||||||For Polio Type 2 the GMC ratio was calculated||1.34|0.72|
71017718|NCT00366678|141542337|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.84||||||95.0|0.6|1.17||||||For Polio Type 3 the GMC ratio was calculated||1.17|0.60|
71017719|NCT00366678|141542338|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.87||||||95.0|0.78|0.98||||||For Pertussis - FHA the GMC ratio was calculated||0.98|0.78|
71017720|NCT00366678|141542338|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.92||||||95.0|0.84|1.02||||||For Pertussis - PT the GMC ratio was calculated||1.02|0.84|
71017721|NCT00366678|141542338|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.85||||||95.0|0.72|1.0||||||For Pertussis - FHA the GMC ratio was calculated||1.00|0.72|
71017722|NCT00366678|141542338|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.99||||||95.0|0.86|1.14||||||For Pertussis - PT the GMC ratio was calculated||1.14|0.86|
71017723|NCT01777191|141542357|SUPERIORITY_OR_OTHER_LEGACY|||||||0.248|TWO_SIDED||||||Fisher Exact|||||||0.248
71017724|NCT00315328|141542360|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum tests were used to assess treatment group differences in the change in Randot Preschool stereoacuity levels ( from baseline to the outcome examination).||||0.96
71017725|NCT00315328|141542361|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum tests used to assess treatment group differences in change in Randot Preschool stereoacuity levels ( from baseline to the outcome examination) among those with anisometropia only.||||0.78
71017726|NCT00315328|141542362|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum tests were used to assess treatment group differences in the change in Randot Preschool stereoacuity levels ( from baseline to the outcome examination) among patients with strabismus or combined mechanism only.||||0.99
71051122|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|||<|0.001|TWO_SIDED|95.0|0.61|1.56|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.56|0.61|<0.001
71051123|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|2.65|||<|0.001|TWO_SIDED|95.0|1.95|3.35|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.35|1.95|<0.001
71017727|NCT00315328|141542363|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Wilcoxon (Mann-Whitney)|||To evaluate WITHIN each treatment group whether stereoacuity changed from baseline to outcome a Wilcoxon sign-rank test was performed to evaluate whether the distribution of change from baseline was zero||||.04
71017728|NCT00315328|141542363|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon (Mann-Whitney)|||To evaluate WITHIN each treatment group whether stereoacuity changed from baseline to outcome a Wilcoxon sign-rank test was performed to evaluate whether the distribution of change from baseline was zero||||0.003
71017729|NCT00315328|141542364|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|Positive mean favors atropine group.||Wilcoxon rank sum tests were used to assess treatment group differences in the parent questionnaire subscale scores at 17 weeks - Social Stigma subscale.||||<0.01
71017730|NCT00315328|141542365|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|Positive mean favors atropine group.||Wilcoxon rank sum tests were used to assess treatment group differences in the parent questionnaire subscale scores at 17 weeks - Compliance subscale.||||<0.01
71017731|NCT00315328|141542366|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum tests were used to assess treatment group differences in the parent questionnaire subscale scores at 17 weeks - Adverse events subscale.||||0.70
71017732|NCT00315328|141542367|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||||95.0|-0.03|0.17||||||95% confidence interval constructed on the treatment group difference in proportion with amblyopic eye visual acuity 20/25 or better at 17 weeks.||0.17|-0.03|
71017733|NCT00315328|141542369|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||||95.0|-0.02|0.18||||||95% confidence interval constructed on the treatment group difference of the proportion improving 15 or more letters from baseline to 17 weeks.||0.18|-0.02|
71051124|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61||||0.015|TWO_SIDED|95.0|0.12|1.09|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.09|0.12|0.015
70931806|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.08|||TWO_SIDED|95.0|-1.4|2.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80||2.8|-1.4|
71017734|NCT00315328|141542370|NON_INFERIORITY_OR_EQUIVALENCE|Treatment equivalence was to be declared if the ends of the 2 1-sided 95% confidence intervals constructed on the difference between adjusted mean visual acuity scores were completely contained within the designated equivalence interval of +/- 5 letters.|Mean Difference (Net)|1.2||||||95.0|-0.7|3.1|||ANCOVA|||The trial was designed to evaluate whether patching and atropine are equivalent treatments for amblyopia in children 7 to 12 years old. The sample size was computed based on a standard deviation of 17-week visual acuity scores of 10 letters, correlation between outcome and baseline visual acuity scores of 0.30 and 10% loss to follow up.||3.1|-0.7|
71017735|NCT00315328|141542373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|||||TWO_SIDED|95.0|0.4|2.2|||ANCOVA|||95% confidence interval constructed on the treatment group difference of mean change in fellow eye visual acuity from baseline to 17 weeks, adjusted for baseline fellow eye visual acuity.||2.2|0.4|
71017736|NCT04253756|141542387|NON_INFERIORITY|The margin of non-inferiority (Delta) was 5g/dl|Mean Difference (Final Values)|0.5||||0.87|TWO_SIDED||||||ANOVA|||||||0.87
71017737|NCT04253756|141542388|NON_INFERIORITY|The non-inferiority margin (Delta) was 10 minutes of run time, no other key parameters|Mean Difference (Final Values)|3.2||||0.32|TWO_SIDED||||||ANOVA|||||||0.32
71017738|NCT00388674|141542391|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.3553|TWO_SIDED|95.03|0.8|1.084|||Cox proportional hazards model||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience|||1.084|0.800|0.3553
71017739|NCT00388674|141542392|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.0676|TWO_SIDED|95.03|0.713|1.012|||Cox proportional hazards model||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience|||1.012|0.713|0.0676
71017740|NCT00388674|141542393|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.1182|TWO_SIDED|95.03|0.769|1.03|||Cox proportional hazards model||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience|||1.030|0.769|0.1182
71017741|NCT00388674|141542394|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.817|1.478|||||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience|||1.478|0.817|
71017742|NCT00388674|141542395|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.727|1.032|||||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience|||1.032|0.727|
71017743|NCT00388674|141542396|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.608|1.365|||||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience|||1.365|0.608|
71017744|NCT00759174|141542397|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.15||||0.033|TWO_SIDED|95.0|1.06|4.34|||Conditional logistic regression|||Conditional logistic regression was stratified by participant.||4.34|1.06|0.033
71017745|NCT00759174|141542398|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.36||||0.003|TWO_SIDED|95.0|1.33|4.19|||Conditional logistic regression|||Conditional logistic regression was stratified by participant.||4.19|1.33|0.003
71017746|NCT00759174|141542399|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.61|||<|0.001|TWO_SIDED|95.0|1.7|7.69|||Conditional logistic regression|||Conditional logistic regression was stratified by participant.||7.69|1.70|<0.001
71017747|NCT01890109|141542400|SUPERIORITY||Least Square Geometric Mean Ratio|1.1||||0.723|TWO_SIDED|95.0|0.66|1.83|||Repeated Measures Analysis of Covariance|||Repeated measures analysis of covariance was performed on the log transformed ratio to baseline of the number of daily moderate to severe hot flashes. Independent variables included treatment, week, and the treatment-by-week interaction; subject served as a random effect; and the log transformed baseline number of daily moderate to severe hot flashes was used as a covariate.||1.83|0.66|0.723
71017748|NCT01890109|141542401|SUPERIORITY||Least Square Geometric Mean Ratio|1.14||||0.551|TWO_SIDED|95.0|0.74|1.74|||Repeated Measures Analysis of Covariance|||Repeated measures analysis of covariance was performed on the log transformed ratio to baseline of the daily hot flash severity score. Independent variables included treatment, week, and the treatment-by-week interaction; subject served as a random effect; and the log transformed baseline daily hot flash severity score was used as a covariate.||1.74|0.74|0.551
71017749|NCT00568776|141542419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.09||0.71|TWO_SIDED|95.0|-0.14|0.21|||Mixed Models Analysis|||||0.21|-0.14|0.71
71017750|NCT00568776|141542420|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.56|STANDARD_ERROR_OF_MEAN|1.9||0.18|TWO_SIDED|95.0|-6.33|1.22|||Mixed Models Analysis|||||1.22|-6.33|0.18
71017751|NCT00568776|141542421|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.11||0.17|TWO_SIDED|95.0|-0.06|0.36|||Mixed Models Analysis|||||0.36|-0.06|0.17
71017752|NCT00568776|141542422|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.39|STANDARD_ERROR_OF_MEAN|2.03||0.49|TWO_SIDED|95.0|-5.41|2.62|||Mixed Models Analysis|||||2.62|-5.41|0.49
71017753|NCT00568776|141542423|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|2.2||0.77|TWO_SIDED|95.0|-3.73|5.03|||Mixed Models Analysis|||||5.03|-3.73|0.77
71017754|NCT00568776|141542424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.47||0.54|TWO_SIDED|95.0|-0.63|1.21|||Mixed Models Analysis|||||1.21|-0.63|0.54
71017755|NCT00568776|141542425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.02|STANDARD_ERROR_OF_MEAN|2.24||0.65|TWO_SIDED|95.0|-3.43|5.46|||Mixed Models Analysis|||||5.46|-3.43|0.65
71017756|NCT00996632|141542426|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||null hypothesis is that drainage volumes are not different||||<0.05
71017757|NCT00996632|141542427|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Wilcoxon (Mann-Whitney)|||null hypothesis is that Stay in Hospital Days are not different||||0.05
71017758|NCT01598740|141542428|SUPERIORITY_OR_OTHER|||||||0.0662||95.0|||||ANCOVA|||One-way analysis of covariance (ANCOVA) common slopes model for a 2-period crossover design.||||0.0662
71017759|NCT01598740|141542429|SUPERIORITY_OR_OTHER|||||||0.1899||95.0|||||ANCOVA|||One-way analysis of covariance (ANCOVA) common slopes model for a 2-period crossover design.||||0.1899
71017760|NCT02861534|141542430|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.269|TWO_SIDED|95.0|0.81|1.06|||Cox proportional hazard model|||||1.06|0.81|0.269
71017761|NCT02861534|141542431|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.048|TWO_SIDED|95.0|0.81|1.0|||Cox proportional hazard model|||||1.00|0.81|0.048
71017762|NCT02861534|141542432|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.019|TWO_SIDED|95.0|0.82|0.98|||Cox proportional hazard model|||||0.98|0.82|0.019
71017763|NCT02861534|141542433|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.023|TWO_SIDED|95.0|0.84|0.99|||Andersen-Gill model|||||0.99|0.84|0.023
71017764|NCT02861534|141542434|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.021|TWO_SIDED|95.0|0.83|0.98|||Cox proportional hazard model|||||0.98|0.83|0.021
71017765|NCT02861534|141542435|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.377|TWO_SIDED|95.0|0.84|1.07|||Cox proportional hazard model|||||1.07|0.84|0.377
71017766|NCT02861534|141542438|OTHER||Difference in Percentage|1.2||||0.121|TWO_SIDED|95.0|-0.3|2.8|||Miettinen & Nurminen method|||||2.8|-0.3|0.121
71105328|NCT04043286|141718081|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.15||0.053|TWO_SIDED|95.0|-0.0000522|0.75|||Wilcoxon (Mann-Whitney)|||"The null hypothesis was that there would be no significant difference in peri-implant bone levels between implants with definitive abutments delivered at the time of surgery, and those subjected to multiple abutment disconnections and reconnections. Power analysis was performed and showed that a sample size of 38 implants was needed to achieve 80% power to detect a difference between the null proportion of 0.500 at a significance level of 0.05.~Type of Statistical Test"||0.75|-0.0000522|0.053
71017767|NCT02861534|141542439|OTHER||Difference in Percentage|0.6||||0.303|TWO_SIDED|95.0|-0.5|1.6|||Miettinen & Nurminen method|||||1.6|-0.5|0.303
71017768|NCT02780115|141542440|SUPERIORITY||LS Mean Diff|1.96||||0.1663|TWO_SIDED|95.0|-0.83|4.74|||ANCOVA|||||4.74|-0.83|0.1663
71017769|NCT02780115|141542440|SUPERIORITY||LS Mean Diff|4.77||||0.0009|TWO_SIDED|95.0|1.98|7.56|||ANCOVA|||||7.56|1.98|0.0009
71017770|NCT02780115|141542440|SUPERIORITY||LS Mean Diff|4.54||||0.0014|TWO_SIDED|95.0|1.79|7.29|||ANCOVA|||||7.29|1.79|0.0014
71017771|NCT02780115|141542440|SUPERIORITY||LS Mean Diff|4.81||||0.0008|TWO_SIDED|95.0|2.03|7.58|||ANCOVA|||||7.58|2.03|0.0008
71017772|NCT01211873|141542463|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71017773|NCT01211873|141542464|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71017774|NCT01211873|141542464|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71017775|NCT01211873|141542465|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71017776|NCT01211873|141542465|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71017777|NCT01294709|141542469|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-6.9|||||TWO_SIDED|90.0|-17.66|3.86|||mixed effects model|mixed effects model with MK-0974 pooled over doses||Telcagepant minus Placebo Treatment Difference||3.86|-17.66|
71017778|NCT01294709|141542470|SUPERIORITY_OR_OTHER||Difference in Least squares meand|-0.056|||||TWO_SIDED|90.0|-0.19|0.076|||mixed effects model|mixed effects model with MK-0974 pooled over doses||Telcagepant minus Placebo Treatment Difference||0.076|-0.19|
71017779|NCT01294709|141542471|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-7.14|||||TWO_SIDED|90.0|-22.03|7.74|||mixed effects model|mixed effects model with MK-0974 pooled over doses||Telcagepant minus Placebo Treatment Difference||7.74|-22.03|
71017780|NCT03466060|141542492|SUPERIORITY||Posterior mean difference|-2.1|STANDARD_DEVIATION|2.23|||TWO_SIDED|95.0|-6.4|2.3||95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.|bayesian multivariate hierarachical||Posterior mean difference was calculated as Test-Control.|1-Minute Follow-up Analysis||2.3|-6.4|
71017781|NCT03466060|141542492|SUPERIORITY||Posertior Mean Difference|-2.5|STANDARD_DEVIATION|2.16|||TWO_SIDED|95.0|-6.8|1.7||95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.|Bayesian Multivariate Hierarchical Model||Posterior mean difference was calculated as Test-Control.|5-minute Follow-up Analysis||1.7|-6.8|
71017782|NCT03466060|141542492|SUPERIORITY||Posterior Mean Difference|-2.7|STANDARD_DEVIATION|2.1|||TWO_SIDED|95.0|-6.9|1.5||95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.|Bayesian multivariate hierarchical model||Posterior mean difference was calculated as Test-Control.|45-Minute Follolw-up Analysis||1.5|-6.9|
71105329|NCT01323192|141718083|SUPERIORITY_OR_OTHER||Difference in least square means|-4.5|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|-6.7|-2.4|||ANCOVA||LS mean of JNS001 minus LS mean of Placebo|||-2.4|-6.7|<0.0001
71017783|NCT03466060|141542492|SUPERIORITY||Posterior Mean Difference|-2.5|STANDARD_DEVIATION|2.01|||TWO_SIDED|95.0|-6.5|1.4|||Bayesian Multivariate Heirarchical Model||Posterior mean difference was calculated as Test-Control.|2-Hour Follow-up Analysis||1.4|-6.5|
71017784|NCT03466060|141542492|SUPERIORITY||Posterior Mean Difference|-1.1|STANDARD_DEVIATION|2.28|||TWO_SIDED|95.0|-5.8|3.1|||Bayesian Multivariate Heirarchical Model||Posterior mean difference was calculated as Test-Control.|1-Minute Follow-up Analysis||3.1|-5.8|
71017785|NCT03466060|141542492|SUPERIORITY|95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.|Posterior Mean Difference|-0.7|STANDARD_DEVIATION|2.2|||TWO_SIDED|95.0|-5.0|3.6|||Bayesian Multivariate Heirarchical Model||Posterior mean difference was calculated as Test-Control.|5-Minute Follow-up Analysis||3.6|-5.0|
71017786|NCT03466060|141542492|NON_INFERIORITY|95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.|Posterior Mean Difference|-2.0|STANDARD_DEVIATION|2.16|||TWO_SIDED|95.0|-6.4|2.3|||Bayesian Multivariate Hierarchical Model||Posterior mean difference was calculated as Test-Control.|45-Minute Follow-up Analysis||2.3|-6.4|
71017787|NCT03466060|141542492|SUPERIORITY||Posterior Mean Difference|-1.5|STANDARD_DEVIATION|2.1|||TWO_SIDED|95.0|-5.8|2.5||95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.|Bayesian Mutlivariate Hiearachical Model||Posterior mean difference was calculated as Test-Control.|2-Hour Follow-up Analysis||2.5|-5.8|
71017788|NCT01612780|141542493|SUPERIORITY||||||<|0.0001||||||Values of p \<0.05 were deemed statistically significant.|t-test, 2 sided|||Study sample size was established to test the hypothesis that the mean SNOT-20 score is reduced by at least 0.8 points from baseline to 1 year post procedure. Using this delta, a 1-sided alpha of 0.25, and 90% power, a sample size of 19 participants was adequate to test the hypothesis.||||<0.0001
71017789|NCT02964910|141542524|NON_INFERIORITY|The criteria of the immunogenicity non-inferiority between CHB group and healthy adults group were: the lower limit of 95% CI of the seroconversion rate difference was not less than -10%.|the seroconversion rate difference(%)|-2.08|||||TWO_SIDED|95.0|-5.23|0.22||||||||0.22|-5.23|
71017790|NCT02964910|141542525|NON_INFERIORITY|The criteria of the immunogenicity non-inferiority between CHB group and healthy adults group were: the lower limit of 95%CI of the GMC ratio was not lower than 0.5.|GMC ratio|0.69|||||TWO_SIDED|95.0|0.55|0.85||||||||0.85|0.55|
71017791|NCT02964910|141542529|OTHER|The differences in incidence rate of ADR\\AE between the two groups were compared.||||||0.778|||||||Chi-squared|||||||0.778
71017792|NCT02964910|141542530|OTHER|The differences in incidence rate of ADR\\AE between the two groups were compared.||||||0.728|||||||Chi-squared|||||||0.728
71017793|NCT02964910|141542531|OTHER|The differences in incidence rate of ADR\\AE between the two groups were compared.||||||0.949|||||||Chi-squared|||||||0.949
71017794|NCT02964910|141542532|OTHER|The differences in incidence rate of ADR\\AE between the two groups were compared.||||||0.614|||||||Chi-squared|||||||0.614
71017795|NCT02964910|141542533|OTHER|The differences in incidence rate of ADR\\AE between the two groups were compared.||||||0.956|||||||Chi-squared|||||||0.956
71105330|NCT01323192|141718084|SUPERIORITY_OR_OTHER||Difference in least square means|-6.9|STANDARD_ERROR_OF_MEAN|1.83||0.0002|||||||ANCOVA||LS mean of JNS001 minus LS mean of Placebo|||||0.0002
71017796|NCT00442338|141542534|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.01||||0.871|TWO_SIDED|95.0|-0.07|0.08|||ANCOVA|The model included a factor for treatment and used the baseline FEV1 as a covariate.||Treatment difference in change from Baseline in FEV1 within the first 60 minutes after study drug administration was assessed as the difference in the least square (LS) means of time weighted average change FEV1 (0-60 min) using an Analysis of Covariance (ANCOVA) model.||0.08|-0.07|0.871
71017797|NCT00442338|141542534|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.01||||0.794|TWO_SIDED|95.0|-0.08|0.06|||ANCOVA|The model included a factor for treatment and used the baseline FEV1 as a covariate.||Treatment difference in change from Baseline in FEV1 within the first 60 minutes after study drug administration was assessed as the difference in the LS means of time weighted average change FEV1 (0-60 min) using an ANCOVA model.||0.06|-0.08|0.794
71017798|NCT00442338|141542534|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.02||||0.675|TWO_SIDED|95.0|-0.06|0.09|||ANCOVA|The model included a factor for treatment and used the baseline FEV1 as a covariate.||Treatment difference in change from Baseline in FEV1 within the first 60 minutes after study drug administration was assessed as the difference in the LS means of time weighted average change FEV1 (0-60 min) using an ANCOVA model.||0.09|-0.06|0.675
71017799|NCT03972709|141542535|SUPERIORITY||Difference in Adjusted Means|0.29|STANDARD_ERROR_OF_MEAN|0.188||0.1206||95.0|-0.08|0.66|||MMRM|||||0.66|-0.08|0.1206
71017800|NCT03972709|141542535|SUPERIORITY||Difference in Adjusted Means|0.12|STANDARD_ERROR_OF_MEAN|0.231||0.6127||95.0|-0.34|0.57|||MMRM|||||0.57|-0.34|0.6127
71017801|NCT03972709|141542542|SUPERIORITY||Difference in Adjusted Means|-0.39|STANDARD_ERROR_OF_MEAN|1.901||0.8388|TWO_SIDED|95.0|-4.14|3.36|||MMRM|||||3.36|-4.14|0.8388
71017802|NCT03972709|141542542|SUPERIORITY||Difference in Adjusted Means|-0.48|STANDARD_ERROR_OF_MEAN|2.384||0.8412|TWO_SIDED|95.0|-5.18|4.23|||MMRM|||||4.23|-5.18|0.8412
71017803|NCT03972709|141542543|SUPERIORITY||Difference in Adjusted Means|0.83|STANDARD_ERROR_OF_MEAN|2.052||0.6865|TWO_SIDED|95.0|-3.22|4.88|||MMRM|||||4.88|-3.22|0.6865
71017804|NCT03972709|141542543|SUPERIORITY||Difference in Adjusted Means|0.2|STANDARD_ERROR_OF_MEAN|2.5||0.9355||95.0|-4.73|5.13|||MMRM|||||5.13|-4.73|0.9355
71017805|NCT00118209|141542577|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.6519|TWO_SIDED|95.0|0.68|1.27|||Log Rank|||||1.27|0.68|0.6519
71017806|NCT00118209|141542578|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
71105331|NCT01323192|141718085|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71105332|NCT01323192|141718086|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
71105333|NCT01323192|141718087|SUPERIORITY_OR_OTHER||Difference in least square means|-6.9|STANDARD_ERROR_OF_MEAN|1.83||0.0003|||||||ANCOVA||LS mean of JNS001 minus LS mean of Placebo|||||0.0003
71105334|NCT01323192|141718088|SUPERIORITY_OR_OTHER|||||||0.4041|||||||ANCOVA|||||||0.4041
71051125|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|1.73|||<|0.001|TWO_SIDED|95.0|1.24|2.22|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.22|1.24|<0.001
71051126|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|2.05|||<|0.001|TWO_SIDED|95.0|1.35|2.74|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.74|1.35|<0.001
71051127|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.92||||0.01|TWO_SIDED|95.0|0.22|1.62|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.62|0.22|0.010
70854113|NCT01106092|141196226|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 3\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 3 is ≥ 2.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-4.78|4.72||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 3) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 3 antibodies, one month after vaccination.||4.72|-4.78|
70854114|NCT01473368|141196275|SUPERIORITY_OR_OTHER|||||||0.026|||||||ANOVA|||||||0.026
71051128|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|1.12|||<|0.001|TWO_SIDED|95.0|0.63|1.61|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.61|0.63|<0.001
71051129|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|2.18|||<|0.001|TWO_SIDED|95.0|1.47|2.88|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.88|1.47|<0.001
71051130|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.022|TWO_SIDED|95.0|0.08|1.06|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.06|0.08|0.022
71051131|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|1.45|||<|0.001|TWO_SIDED|95.0|0.95|1.95|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.95|0.95|<0.001
71051132|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|||<|0.001|TWO_SIDED|95.0|0.9|2.3|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.30|0.90|<0.001
71051133|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.72||||0.045|TWO_SIDED|95.0|0.02|1.43|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.43|0.02|0.045
71051134|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.88|||<|0.001|TWO_SIDED|95.0|0.38|1.38|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.38|0.38|<0.001
71051135|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|1.78|||<|0.001|TWO_SIDED|95.0|1.09|2.47|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.47|1.09|<0.001
71051136|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56||||0.024|TWO_SIDED|95.0|0.07|1.04|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.04|0.07|0.024
71051137|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|1.16|||<|0.001|TWO_SIDED|95.0|0.67|1.65|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.65|0.67|<0.001
70854115|NCT01473368|141196279|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71051138|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|1.23|||<|0.001|TWO_SIDED|95.0|0.54|1.92|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.92|0.54|<0.001
71017807|NCT00118209|141542579|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.6414|TWO_SIDED|95.0|0.75|1.59|||Log Rank|||||1.59|0.75|0.6414
70854116|NCT01347580|141196300|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.8214|TWO_SIDED|95.0|0.799|1.327||pvalue at 0.025 , adjusted for multiple comparisons|Regression, Logistic|||||1.327|0.799|0.8214
71017808|NCT00090259|141542586|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.899||||0.027|TWO_SIDED|95.0|0.818|0.988|||Regression, Cox|Model terms: treatment, region and β-blocker use at randomization|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg|||0.988|0.818|0.027
71017809|NCT00090259|141542587|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.924||||0.068|TWO_SIDED|95.0|0.848|1.006|||Regression, Cox|Model terms: treatment, region and β-blocker use at randomization|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg|||1.006|0.848|0.068
71017810|NCT00090259|141542588|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.936||||0.235|TWO_SIDED|95.0|0.84|1.044|||Regression, Cox|Model terms: treatment, region and β-blocker use at randomization|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg|||1.044|0.840|0.235
71017811|NCT00090259|141542589|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.865||||0.025|TWO_SIDED|95.0|0.762|0.982|||Regression, Cox|Model terms: treatment, region and β-blocker use at randomization|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg|||0.982|0.762|0.025
71017812|NCT00090259|141542590|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.892||||0.023|TWO_SIDED|95.0|0.808|0.984|||Regression, Cox|Model terms: treatment, region and β-blocker use at randomization|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg|||0.984|0.808|0.023
71017813|NCT00345969|141542591|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANOVA|||||||0.01
71017814|NCT00345969|141542592|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||ANOVA|||||||0.55
71017815|NCT00345969|141542593|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||ANOVA|||||||0.23
71017816|NCT00345969|141542594|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||ANOVA|||||||0.43
70854117|NCT01347580|141196301|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.074||||0.6322|TWO_SIDED|95.0|0.801|1.441||P value at 0.025 adjusted for multiple comparisons|Regression, Logistic|||||1.441|0.801|0.6322
71017817|NCT00345969|141542595|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED||||||ANOVA|||||||0.33
71017818|NCT00345969|141542596|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED||||||ANOVA|||||||0.93
71017819|NCT00345969|141542597|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||ANOVA|||||||0.24
71017820|NCT00345969|141542598|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||ANOVA|||||||0.49
71017821|NCT00345969|141542599|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||ANOVA|||||||0.19
71017822|NCT00345969|141542600|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||ANOVA|||||||0.71
71017823|NCT00345969|141542601|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||ANOVA|||||||0.44
71017824|NCT00345969|141542602|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||ANOVA|||||||0.89
71017825|NCT00345969|141542603|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||ANOVA|||||||0.13
71017826|NCT00285012|141542607|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.4|||<|0.0001||95.0|4.99|14.14||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Primary endpoint was based on a CO confirmed 4-week CQR (weeks 4 through 12 inclusive). Intent was to evaluate the alternative hypothesis that varenicline is superior to placebo for smoking cessation after 12 weeks of treatment in subjects with mild to moderate COPD.||14.14|4.99|<0.0001
71017827|NCT00285012|141542608|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.88|||<|0.0001||95.0|2.75|8.65||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline versus (vs) placebo at Week 24||8.65|2.75|<0.0001
71017828|NCT00285012|141542608|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.04|||<|0.0001||95.0|2.13|7.67||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 52||7.67|2.13|<0.0001
70931807|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.08|||TWO_SIDED|95.0|-1.5|2.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 84||2.7|-1.5|
70931808|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|95.0|-1.8|2.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84||2.4|-1.8|
70931809|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|-1.8|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 88||2.5|-1.8|
70931810|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|-1.9|2.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88||2.4|-1.9|
70931811|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|-1.9|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 92||2.5|-1.9|
70931812|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|95.0|-1.8|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92||2.5|-1.8|
70931813|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.12|||TWO_SIDED|95.0|-1.9|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 96||2.5|-1.9|
70931814|NCT02307682|141364339|OTHER|Treatment difference|Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|-1.6|2.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||2.7|-1.6|
70931815|NCT02307682|141364340|OTHER|Treatment difference|Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-1.9|1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4 to Week 48||1.1|-1.9|
70931816|NCT02307682|141364340|OTHER|Treatment difference|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|95.0|-1.5|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 48||1.6|-1.5|
71017829|NCT00285012|141542609|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.17|||<|0.0001||95.0|2.96|9.02||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 24||9.02|2.96|<0.0001
71051139|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.62||||0.079|TWO_SIDED|95.0|-0.07|1.32|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.32|-0.07|0.079
71051140|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.015|TWO_SIDED|95.0|0.12|1.09|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.09|0.12|0.015
71051141|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|1.25|||<|0.001|TWO_SIDED|95.0|0.56|1.94|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.94|0.56|<0.001
70931817|NCT02307682|141364340|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.87|||TWO_SIDED|95.0|-1.8|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4 to Week 96||1.6|-1.8|
70931818|NCT02307682|141364340|OTHER|Treatment difference|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.88|||TWO_SIDED|95.0|-1.7|1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 96||1.8|-1.7|
70931819|NCT02307682|141364341|OTHER|Treatment difference|Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|95.0|-2.0|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12 to Week 48||1.2|-2.0|
70931820|NCT02307682|141364341|OTHER|Treatment difference|Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|95.0|-1.6|1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12 to Week 48||1.8|-1.6|
71051142|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19||||0.438|TWO_SIDED|95.0|-0.29|0.67|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.67|-0.29|0.438
71051143|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8||||0.001|TWO_SIDED|95.0|0.31|1.29|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.29|0.31|0.001
71051144|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|1.06||||0.003|TWO_SIDED|95.0|0.37|1.75|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.75|0.37|0.003
70931821|NCT02307682|141364341|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|-1.9|1.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12 to Week 96||1.7|-1.9|
70931822|NCT02307682|141364341|OTHER|Treatment difference|Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.92|||TWO_SIDED|95.0|-1.7|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12 to Week 96||1.9|-1.7|
70931823|NCT02307682|141364342|OTHER|Treatment difference|Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.08|||TWO_SIDED|95.0|-1.7|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|||2.5|-1.7|
70931824|NCT02307682|141364342|OTHER|Treatment difference|Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|95.0|-1.7|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||2.5|-1.7|
70931825|NCT02307682|141364343|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-4.2|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||4.2|-4.2|
70931826|NCT02307682|141364343|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-2.8|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||5.8|-2.8|
70931827|NCT02307682|141364343|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-4.4|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||5.9|-4.4|
70931828|NCT02307682|141364343|OTHER||Difference in proportions|4.2|||||TWO_SIDED|95.0|-1.2|10.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||10.0|-1.2|
70931829|NCT02307682|141364343|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-5.9|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||5.9|-5.9|
70931830|NCT02307682|141364343|OTHER||Difference in proportions|4.9|||||TWO_SIDED|95.0|-0.5|11.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||11.0|-0.5|
71017830|NCT00285012|141542609|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.92|||<|0.0001||95.0|2.18|7.07||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 52||7.07|2.18|<0.0001
71017831|NCT00285012|141542610|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.99|||<|0.0001||95.0|4.39|11.11||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 12||11.11|4.39|<0.0001
71017832|NCT00285012|141542610|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.85|||<|0.0001||95.0|1.79|4.54|||Regression, Logistic|p-value obtained from a logistic regression model including the main effects of treatment and pooled center|odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 24||4.54|1.79|<0.0001
70931831|NCT02307682|141364343|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-3.7|8.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||8.0|-3.7|
70931832|NCT02307682|141364343|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-3.8|8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||8.3|-3.8|
70931833|NCT02307682|141364343|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-5.9|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||6.1|-5.9|
71017833|NCT00285012|141542610|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.0008||95.0|1.37|3.48||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 52||3.48|1.37|0.0008
71017834|NCT00285012|141542611|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.45||||0.0002||95.0|1.52|3.95||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 52||3.95|1.52|0.0002
70854118|NCT01347580|141196302|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.027||||0.9056|TWO_SIDED|95.0|0.661|1.595|||Regression, Logistic|||||1.595|0.661|0.9056
70854119|NCT01347580|141196303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.215||||0.4168|TWO_SIDED|95.0|0.76|1.942|||Regression, Logistic|||||1.942|0.760|0.4168
71017835|NCT00285012|141542612|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANCOVA|p-value based on ANCOVA model with treatment and center as factors and baseline value as covariate.||Varenicline vs placebo at Week 12 \[LOCF\] pre-bronchodilator||||0.140
71017836|NCT00285012|141542612|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||ANCOVA|p-value based on ANCOVA model with treatment and center as factors and baseline value as covariate.||Varenicline vs placebo at Week 12 \[LOCF\] post-bronchodilator||||0.007
71017837|NCT00285012|141542612|SUPERIORITY_OR_OTHER|||||||0.684||95.0|||||ANCOVA|p-value based on ANCOVA model with treatment and center as factors and baseline value as covariate.||Varenicline vs placebo at Week 52 \[LOCF\] pre-bronchodilator||||0.684
71017838|NCT00285012|141542612|SUPERIORITY_OR_OTHER|||||||0.901||95.0|||||ANCOVA|p-value based on ANCOVA model with treatment and center as factors and baseline value as covariate.||Varenicline vs placebo at Week 52 \[LOCF\] post-bronchodilator||||0.901
71017839|NCT00285012|141542613|SUPERIORITY_OR_OTHER|||||||0.078||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 12 Mental State||||0.078
71017840|NCT00285012|141542613|SUPERIORITY_OR_OTHER|||||||0.109||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 24 Mental State||||0.109
71017841|NCT00285012|141542613|SUPERIORITY_OR_OTHER|||||||0.281||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 52 Mental State||||0.281
71017842|NCT00285012|141542613|SUPERIORITY_OR_OTHER|||||||0.581||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 12 Functional State||||0.581
71017843|NCT00285012|141542613|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 24 Functional State||||0.290
71017844|NCT00285012|141542613|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 52 Functional State||||0.063
71017845|NCT00285012|141542613|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 12 Respiratory Symptoms||||0.002
71017846|NCT00285012|141542613|SUPERIORITY_OR_OTHER|||||||0.081||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 24 Respiratory Symptoms||||0.081
71017847|NCT00285012|141542613|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 52 Respiratory Symptoms||||0.016
71017848|NCT00285012|141542613|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 12 Total Score||||0.033
71017849|NCT00285012|141542613|SUPERIORITY_OR_OTHER|||||||0.078||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 24 Total Score||||0.078
71017850|NCT00285012|141542613|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 52 Total Score||||0.023
71017851|NCT02873195|141542617|SUPERIORITY||Hazard Ratio (HR)|0.725||||0.051|TWO_SIDED|95.0|0.491|1.07|||Log Rank|||||1.07|0.491|0.051
71017852|NCT02873195|141542618|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.4|TWO_SIDED|95.0|0.56|1.56|||Log Rank|||||1.56|0.56|0.40
71017853|NCT02873195|141542619|SUPERIORITY|||||||0.4876|||||||Fisher Exact|||||||0.4876
71017854|NCT05004181|141542635|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the GMR was greater than 0.67.|Geometric mean ratio|13.12|||||TWO_SIDED|95.0|11.14|15.45|||||GMRs and 2-sided 95% CIs were based on the analysis of logarithmically transformed neutralizing titers using a linear regression model with terms of age, sex, and group.|||15.45|11.14|
71017855|NCT05004181|141542636|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the difference of percentages was greater than -10%.|Difference in Percentages|-4.55|||||TWO_SIDED|95.0|-10.04|0.83|||||Adjusted difference in percentages were estimated using minimum risk weights and stratified by sex and age group.|||0.83|-10.04|
71017856|NCT05004181|141542638|OTHER||Difference in Percentages|36.73|||||TWO_SIDED|95.0|19.21|51.17|||||Adjusted difference was estimated using the minimum risk weights and stratified by sex and age group.|||51.17|19.21|
71017857|NCT00633217|141542653|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 95% confidence interval for the mean difference in 2-hour post-dose FEV1 change from baseline fell above -75 mL, then HFA MDI could be deemed non-inferior to DISKUS treatment response.||||||0.021||95.0|||||ANCOVA|||||||0.021
71017858|NCT03205163|141542748|OTHER||GMR|1.35||||0.032|TWO_SIDED|95.0|1.04|1.77|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an analysis of variance (ANOVA) model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and geometric mean ratio (GMR) were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||1.77|1.04|0.032
71017859|NCT03205163|141542749|OTHER||GMR|1.17|||<|0.001|TWO_SIDED|95.0|1.09|1.25|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||1.25|1.09|<0.001
71017860|NCT03205163|141542750|OTHER||GMR|4.13|||<|0.001|TWO_SIDED|95.0|2.94|5.79|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||5.79|2.94|<0.001
71017861|NCT03205163|141542751|OTHER||GMR|3.24|||<|0.001|TWO_SIDED|95.0|2.76|3.79|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||3.79|2.76|<0.001
70931834|NCT02307682|141364343|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-2.4|9.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||9.9|-2.4|
71051145|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.45||||0.204|TWO_SIDED|95.0|-0.25|1.14|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.14|-0.25|0.204
71051146|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61||||0.014|TWO_SIDED|95.0|0.12|1.1|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.10|0.12|0.014
71051147|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.84||||0.018|TWO_SIDED|95.0|0.15|1.53|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.53|0.15|0.018
71051148|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04||||0.867|TWO_SIDED|95.0|-0.44|0.52|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.52|-0.44|0.867
70931835|NCT02307682|141364343|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-4.2|7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||7.3|-4.2|
70931836|NCT02307682|141364343|OTHER||Difference in proportions|7.2|||||TWO_SIDED|95.0|0.8|13.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||13.4|0.8|
70931837|NCT02307682|141364343|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-4.3|8.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||8.5|-4.3|
71051149|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41||||0.099|TWO_SIDED|95.0|-0.08|0.9|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.90|-0.08|0.099
71051150|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8||||0.024|TWO_SIDED|95.0|0.11|1.49|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.49|0.11|0.024
71051151|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.43||||0.228|TWO_SIDED|95.0|-0.27|1.12|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.12|-0.27|0.228
71051152|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.136|TWO_SIDED|95.0|-0.12|0.86|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.86|-0.12|0.136
71051153|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.078|TWO_SIDED|95.0|-0.07|1.28|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.28|-0.07|0.078
71051154|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.716|TWO_SIDED|95.0|-0.38|0.56|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.56|-0.38|0.716
71051155|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31||||0.197|TWO_SIDED|95.0|-0.16|0.79|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.79|-0.16|0.197
71051156|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.52||||0.131|TWO_SIDED|95.0|-0.15|1.19|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.19|-0.15|0.131
71051157|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29||||0.399|TWO_SIDED|95.0|-0.39|0.97|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.97|-0.39|0.399
71051158|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.349|TWO_SIDED|95.0|-0.25|0.7|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.70|-0.25|0.349
71051159|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46||||0.169|TWO_SIDED|95.0|-0.2|1.12|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.12|-0.20|0.169
71051160|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.937|TWO_SIDED|95.0|-0.48|0.44|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.44|-0.48|0.937
71051161|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.351|TWO_SIDED|95.0|-0.25|0.69|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.69|-0.25|0.351
71051162|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48||||0.151|TWO_SIDED|95.0|-0.18|1.14|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.14|-0.18|0.151
71051163|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24||||0.476|TWO_SIDED|95.0|-0.42|0.9|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.90|-0.42|0.476
71051164|NCT02912650|141608108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24||||0.31|TWO_SIDED|95.0|-0.22|0.71|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.71|-0.22|0.310
70854120|NCT01347580|141196304|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.189||||0.0307|TWO_SIDED|95.0|0.042|0.856|||Regression, Logistic|||||0.856|0.042|0.0307
71105335|NCT02964377|141718119|EQUIVALENCE|Difference in trough vs. peak values was evaluated using a paired t-test analysis.||||||0.0482|||||||t-test, 2 sided|||||||0.0482
70931838|NCT02307682|141364343|OTHER||Difference in proportions|3.2|||||TWO_SIDED|95.0|-3.4|9.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||9.4|-3.4|
70854121|NCT01347580|141196305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.132||||0.344|TWO_SIDED|95.0|0.876|1.462|||Regression, Logistic|||||1.462|0.876|0.344
70931839|NCT02307682|141364343|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-5.0|7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||7.2|-5.0|
70931840|NCT02307682|141364343|OTHER||Difference in proportions|7.9|||||TWO_SIDED|95.0|1.5|14.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||14.4|1.5|
71017862|NCT03205163|141542752|OTHER||GMR|0.143|||<|0.001|TWO_SIDED|95.0|0.118|0.172|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||0.172|0.118|<0.001
71017863|NCT03205163|141542753|OTHER||GMR|0.153|||<|0.001|TWO_SIDED|95.0|0.138|0.17|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||0.170|0.138|<0.001
71017864|NCT03205163|141542754|OTHER||GMR|0.622||||0.003|TWO_SIDED|95.0|0.492|0.786|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||0.786|0.492|0.003
71017865|NCT03205163|141542755|OTHER||GMR|0.599|||<|0.001|TWO_SIDED|95.0|0.525|0.684|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||0.684|0.525|<0.001
71017866|NCT03205163|141542756|OTHER||GMR|7.0|||<|0.001|TWO_SIDED|95.0|5.78|8.48|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||8.48|5.78|<0.001
71017867|NCT03205163|141542757|OTHER||GMR|6.54|||<|0.001|TWO_SIDED|95.0|5.89|7.27|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||7.27|5.89|<0.001
71017868|NCT03205163|141542758|OTHER||GMR|4.54|||<|0.001|TWO_SIDED|95.0|3.64|5.66|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||5.66|3.64|<0.001
71017869|NCT03205163|141542759|OTHER||GMR|4.32|||<|0.001|TWO_SIDED|95.0|3.96|4.72|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||4.72|3.96|<0.001
71017870|NCT03205163|141542760|OTHER||GMR|1.36||||0.063|TWO_SIDED|95.0|0.978|1.89|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||1.89|0.978|0.063
71017871|NCT03205163|141542761|OTHER||GMR|1.18|||<|0.001|TWO_SIDED|95.0|1.1|1.26|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||1.26|1.10|<0.001
71017872|NCT03205163|141542762|OTHER||GMR|4.57|||<|0.001|TWO_SIDED|95.0|4.0|5.23|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||5.23|4.00|<0.001
71017873|NCT03205163|141542763|OTHER||GMR|4.46|||<|0.001|TWO_SIDED|95.0|4.16|4.79|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||4.79|4.16|<0.001
71051165|NCT02912650|141608109|SUPERIORITY_OR_OTHER||LS Mean Difference|7.35|||<|0.001|TWO_SIDED|95.0|6.09|8.61|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||8.61|6.09|<0.001
71051166|NCT02912650|141608109|SUPERIORITY_OR_OTHER||LS Mean Difference|1.41||||0.002|TWO_SIDED|95.0|0.53|2.28|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.28|0.53|0.002
71105336|NCT02964377|141718119|EQUIVALENCE|Difference in trough vs. peak values was evaluated using a paired t-test analysis.||||||0.0075|||||||t-test, 2 sided|||||||0.0075
70931841|NCT02307682|141364343|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-5.4|7.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||7.0|-5.4|
70931842|NCT02307682|141364343|OTHER||Difference in proportions|8.1|||||TWO_SIDED|95.0|2.1|14.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||14.5|2.1|
71017874|NCT05257109|141542764|OTHER|Mixed effects models with water concentration as the within subject factor and irritation as outcome. Outcome analyses will be intent-to-treat and using mixed-effects models. If model assumptions will appear to be violated, we will transform the data or fit more flexible generalized linear or nonparametric mixed models. A significant main effect of condition will be considered supportive of our hypothesis. Formal power analyses were not conducted for this pilot study.|Median Difference (Final Values)|0.67||||0.0014|TWO_SIDED|||||Significant p-value set at \<0.05|Mixed Models Analysis|||||||0.0014
71017875|NCT05257109|141542765|OTHER|Mixed effects models with water concentration as the within subject factor and LHS as outcome. Outcome analyses will be intent-to-treat and using mixed-effects models. If model assumptions will appear to be violated, we will transform the data or fit more flexible generalized linear or nonparametric mixed models. A significant main effect of condition will be considered supportive of our hypothesis. Formal power analyses were not conducted for this pilot study.|Mean Difference (Final Values)|1.55|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<.05
71017876|NCT05257109|141542766|OTHER|Mixed effects models with water concentration as the within subject factor and DEQ as outcome. Outcome analyses will be intent-to-treat and using mixed-effects models. If model assumptions will appear to be violated, we will transform the data or fit more flexible generalized linear or nonparametric mixed models. A significant main effect of condition will be considered supportive of our hypothesis. Formal power analyses were not conducted for this pilot study.|Mean Difference (Final Values)|3.28|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<.05
71017877|NCT03993288|141542767|NON_INFERIORITY|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval for the mean value calculated by the least squares method did not exceed the predetermined boundary of non-inferiority of 5 g/L|Mean Difference (Net)|-0.24||||0.0032|TWO_SIDED|95.0|-4.86|4.38|||ANCOVA|||||4.38|-4.86|0.0032
71017878|NCT00915473|141542773|SUPERIORITY_OR_OTHER|||||||0.98|||||||Chi-squared|||||||0.98
71017879|NCT00915473|141542774|SUPERIORITY_OR_OTHER|||||||0.52|||||||t-test, 2 sided|||Severe Migraine Frequency||||0.52
71017880|NCT00915473|141542774|SUPERIORITY_OR_OTHER|||||||0.52|||||||t-test, 2 sided|||At least Moderate Migraine Frequency||||0.52
71017881|NCT00915473|141542774|SUPERIORITY_OR_OTHER|||||||0.47|||||||t-test, 2 sided|||At Least Mild Migraine Frequency||||0.47
71017882|NCT00915473|141542775|SUPERIORITY_OR_OTHER|||||||0.9|||||||t-test, 2 sided|||||||0.90
71017883|NCT00915473|141542776|SUPERIORITY_OR_OTHER|||||||0.47|||||||t-test, 2 sided|||||||0.47
71017884|NCT01389024|141542777|SUPERIORITY||Incidence rate ratio|0.216||||0.2914|TWO_SIDED|90.0|0.009|1.66|||Poisson Regression||We calculated confidence intervals from exact Poisson regression.|||1.66|.009|0.2914
71017885|NCT00819091|141542781|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001||95.0|-0.7|-0.24|||ANCOVA|ANCOVA model includes treatment and number of prior oral anti-diabetic drug as fixed classification effects and baseline HbA1c as a linear covariate||Linagliptin 5.0 mg versus placebo||-0.24|-0.70|< 0.0001
71017886|NCT00819091|141542782|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|5.5||0.2406||95.0|-17.2|4.3|||ANCOVA|ANCOVA model includes treatment and number of prior oral anti-diabetic drug as fixed classification effects and baseline HbA1c as a linear covariate||Linagliptin 5.0 mg versus placebo||4.3|-17.2|0.2406
71017887|NCT00819091|141542783|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.466||||0.0065||95.0|1.684|24.825|||Regression, Logistic|||Linagliptin 5.0 mg versus placebo||24.825|1.684|0.0065
71051167|NCT02912650|141608109|SUPERIORITY_OR_OTHER||LS Mean Difference|1.98|||<|0.001|TWO_SIDED|95.0|1.09|2.88|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.88|1.09|<0.001
71051168|NCT02912650|141608109|SUPERIORITY_OR_OTHER||LS Mean Difference|5.94|||<|0.001|TWO_SIDED|95.0|4.69|7.2|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||7.20|4.69|<0.001
71051169|NCT02912650|141608109|SUPERIORITY_OR_OTHER||LS Mean Difference|5.37|||<|0.001|TWO_SIDED|95.0|4.1|6.63|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||6.63|4.10|<0.001
71051170|NCT02912650|141608109|SUPERIORITY_OR_OTHER||LS Mean Difference|0.58||||0.203|TWO_SIDED|95.0|-0.31|1.47|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.47|-0.31|0.203
71051171|NCT02912650|141608109|SUPERIORITY_OR_OTHER||LS Mean Difference|24.5|||<|0.001|TWO_SIDED|95.0|20.1|28.9|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||28.90|20.10|<0.001
71051172|NCT02912650|141608109|SUPERIORITY_OR_OTHER||LS Mean Difference|4.44||||0.005|TWO_SIDED|95.0|1.37|7.52|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||7.52|1.37|0.005
71051173|NCT02912650|141608109|SUPERIORITY_OR_OTHER||LS Mean Difference|11.36|||<|0.001|TWO_SIDED|95.0|8.23|14.48|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||14.48|8.23|<0.001
71105337|NCT02964377|141718119|EQUIVALENCE|Difference in trough vs. peak values was evaluated using a paired t-test analysis.||||||0.0083|||||||t-test, 2 sided|||||||0.0083
70931843|NCT02307682|141364343|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-4.4|8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||8.1|-4.4|
71051174|NCT02912650|141608109|SUPERIORITY_OR_OTHER||LS Mean Difference|20.06|||<|0.001|TWO_SIDED|95.0|15.66|24.45|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||24.45|15.66|<0.001
71017888|NCT00819091|141542784|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.653||||0.2431||95.0|0.515|13.652|||Regression, Logistic|||Linagliptin 5.0 mg versus placebo||13.652|0.515|0.2431
71017889|NCT00819091|141542785|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.125||||0.0001||95.0|2.747|9.562|||Regression, Logistic|||Linagliptin 5.0 mg versus placebo||9.562|2.747|0.0001
71017890|NCT00819091|141542786|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.41|||<|0.0001||95.0|-0.585|-0.23|||Mixed Models Analysis|MMRM with treatment, number oral anti-diabetic drugs, week within patients, week-treatment interaction and baseline HbA1c as a linear covariate.||Linagliptin 5.0 mg versus placebo||-0.230|-0.585|<0.0001
71017891|NCT00819091|141542787|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.5|||<|0.0001||95.0|-0.72|-0.276|||Mixed Models Analysis|MMRM with treatment, number oral anti-diabetic drugs, week within patients, week-treatment interaction and baseline HbA1c as a linear covariate.||Linagliptin 5.0 mg versus placebo||-0.276|-0.720|<0.0001
71017892|NCT00819091|141542788|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47||||0.0002||95.0|-0.716|-0.226|||Mixed Models Analysis|MMRM with treatment, number oral anti-diabetic drugs, week within patients, week-treatment interaction and baseline HbA1c as a linear covariate.||Linagliptin 5.0 mg versus placebo||-0.226|-0.716|0.0002
71017893|NCT00819091|141542789|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|4.6||0.197||95.0|-14.9|3.1|||ANCOVA|ANCOVA model includes treatment and number of prior oral anti-diabetic drug as fixed classification effects and baseline HbA1c as a linear covariate||Linagliptin 5.0 mg versus placebo||3.1|-14.9|0.197
71017894|NCT00819091|141542790|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-14.5|STANDARD_ERROR_OF_MEAN|5.6||0.0105||95.0|-25.5|-3.4|||ANCOVA|ANCOVA model includes treatment and number of prior oral anti-diabetic drug as fixed classification effects and baseline HbA1c as a linear covariate||Linagliptin 5.0 mg versus placebo||-3.4|-25.5|0.0105
71017895|NCT01461369|141542792|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-11.68|STANDARD_ERROR_OF_MEAN|3.806||0.0024|TWO_SIDED|95.0|-19.17|-4.19|||Mixed Models Analysis|||||-4.19|-19.17|0.0024
71017896|NCT01461369|141542792|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-6.58|STANDARD_ERROR_OF_MEAN|3.739||0.0795|TWO_SIDED|95.0|-13.94|0.78|||Mixed Models Analysis|||||0.78|-13.94|0.0795
71017897|NCT01461369|141542793|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-15.82|STANDARD_ERROR_OF_MEAN|3.552|<|0.0001|TWO_SIDED|95.0|-22.82|-8.83|||Mixed Models Analysis|||||-8.83|-22.82|<0.0001
71051175|NCT02912650|141608109|SUPERIORITY_OR_OTHER||LS Mean Difference|13.14|||<|0.001|TWO_SIDED|95.0|8.71|17.57|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||17.57|8.71|<0.001
71051176|NCT02912650|141608109|SUPERIORITY_OR_OTHER||LS Mean Difference|6.92|||<|0.001|TWO_SIDED|95.0|3.8|10.04|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||10.04|3.80|<0.001
71051177|NCT02912650|141608109|SUPERIORITY_OR_OTHER||LS Mean Difference|34.83|||<|0.001|TWO_SIDED|95.0|26.09|43.57|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||43.57|26.09|<0.001
71051178|NCT02912650|141608109|SUPERIORITY_OR_OTHER||LS Mean Difference|5.85||||0.06|TWO_SIDED|95.0|-0.25|11.95|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||11.95|-0.25|0.060
71051179|NCT02912650|141608109|SUPERIORITY_OR_OTHER||LS Mean Difference|16.75|||<|0.001|TWO_SIDED|95.0|10.54|22.95|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||22.95|10.54|<0.001
71051180|NCT02912650|141608109|SUPERIORITY_OR_OTHER||LS Mean Difference|28.98|||<|0.001|TWO_SIDED|95.0|20.26|37.71|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||37.71|20.26|<0.001
71017898|NCT01461369|141542793|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.8|STANDARD_ERROR_OF_MEAN|3.481||0.0052|TWO_SIDED|95.0|-16.66|-2.95|||Mixed Models Analysis|||||-2.95|-16.66|0.0052
71017899|NCT01461369|141542794|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-12.43|STANDARD_ERROR_OF_MEAN|3.776||0.0011|TWO_SIDED|95.0|-19.87|-4.99|||Mixed Models Analysis|||||-4.99|-19.87|0.0011
71017900|NCT01461369|141542794|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.56|STANDARD_ERROR_OF_MEAN|3.707||0.1349|TWO_SIDED|95.0|-12.86|1.74|||Mixed Models Analysis|||||1.74|-12.86|0.1349
71017901|NCT01461369|141542795|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-13.24|STANDARD_ERROR_OF_MEAN|3.377||0.0001|TWO_SIDED|95.0|-19.89|-6.59|||ANCOVA|||||-6.59|-19.89|0.0001
71017902|NCT01461369|141542795|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-7.48|STANDARD_ERROR_OF_MEAN|3.313||0.0248|TWO_SIDED|95.0|-14.0|-0.96|||ANCOVA|||||-0.96|-14.00|0.0248
71017903|NCT01461369|141542796|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-12.63|STANDARD_ERROR_OF_MEAN|3.396||0.0002|TWO_SIDED|95.0|-19.32|-5.94|||ANCOVA|||||-5.94|-19.32|0.0002
71017904|NCT01461369|141542796|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-7.03|STANDARD_ERROR_OF_MEAN|3.339||0.0363|TWO_SIDED|95.0|-13.6|-0.45|||ANCOVA|||||-0.45|-13.60|0.0363
71017905|NCT01461369|141542797|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.38|STANDARD_ERROR_OF_MEAN|3.441||0.0028|TWO_SIDED|95.0|-17.16|-3.6|||ANCOVA|||||-3.60|-17.16|0.0028
71051181|NCT02912650|141608109|SUPERIORITY_OR_OTHER||LS Mean Difference|18.08|||<|0.001||95.0|9.29|26.88|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||26.88|9.29|<0.001
71051182|NCT02912650|141608109|SUPERIORITY_OR_OTHER||LS Mean Difference|10.9|||<|0.001|TWO_SIDED|95.0|4.7|17.1|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||17.10|4.70|<0.001
71051183|NCT02912650|141608110|SUPERIORITY_OR_OTHER||LS Mean Difference|2.12|||<|0.001|TWO_SIDED|95.0|1.72|2.51|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.51|1.72|<0.001
71051184|NCT02912650|141608110|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44||||0.002|TWO_SIDED|95.0|0.16|0.71|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.71|0.16|0.002
71051185|NCT02912650|141608110|SUPERIORITY_OR_OTHER||LS Mean Difference|0.58|||<|0.001|TWO_SIDED|95.0|0.3|0.86|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.86|0.30|<0.001
71051186|NCT02912650|141608110|SUPERIORITY_OR_OTHER||LS Mean Difference|1.68|||<|0.001|TWO_SIDED|95.0|1.29|2.08|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.08|1.29|<0.001
71051187|NCT02912650|141608110|SUPERIORITY_OR_OTHER||LS Mean Difference|1.53|||<|0.001|TWO_SIDED|95.0|1.14|1.93|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.93|1.14|<0.001
70851124|NCT00724711|141190448|NON_INFERIORITY_OR_EQUIVALENCE|"This study was designed to show noninferiority (change of \< 12%) in regard of proportions of responders (TLOVR) at Week 48.~With 170 subjects in each group, the lower limit of observed one-sided 97.5% confidence interval was expected to be greater than -0.120 with 80% power when the proportion of responders in both treatment groups is 0.820 (82%) at Week 48.~312 subjects were enrolled, representing 8% less than planned (n = 340). As a result, power to claim non-inferiority decreased to 78%."|Difference in percentages between groups|3.0|||||TWO_SIDED|95.0|-5.1|11.2|||Inverted two one-sided tests|Inverted two one-sided tests with the standardized statistic||"Null hypothesis: The TVD group is at least 12% worse than the ABC/3TC group with respect to the percentage of subjects maintaining HIV-1 RNA \< 200 copies/mL through Week 48 (responder rate, as defined by the TLOVR algorithm)~Alternative hypothesis: The TVD group is less than 12% worse than the ABC/3TC group with respect to the percentage of subjects maintaining HIV-1 RNA \< 200 copies/mL through Week 48 (responder rate, as defined by the TLOVR algorithm)"||11.2|-5.1|
70851125|NCT05111301|141190485|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.004
70851126|NCT05111301|141190486|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.004
70851127|NCT05111301|141190487|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.54
70851128|NCT05111301|141190488|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.03
71051188|NCT02912650|141608110|SUPERIORITY_OR_OTHER||LS Mean Difference|0.15||||0.303|TWO_SIDED|95.0|-0.13|0.43|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.43|-0.13|0.303
71051189|NCT02912650|141608110|SUPERIORITY_OR_OTHER||LS Mean Difference|7.22|||<|0.001|TWO_SIDED|95.0|5.86|8.58|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||8.58|5.86|<0.001
71051190|NCT02912650|141608110|SUPERIORITY_OR_OTHER||LS Mean Difference|1.58||||0.001|TWO_SIDED|95.0|0.63|2.53|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.53|0.63|0.001
71051191|NCT02912650|141608110|SUPERIORITY_OR_OTHER||LS Mean Difference|3.48|||<|0.001|TWO_SIDED|95.0|2.52|4.45|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.45|2.52|<0.001
71051192|NCT02912650|141608110|SUPERIORITY_OR_OTHER||LS Mean Difference|5.64|||<|0.001|TWO_SIDED|95.0|4.28|6.99|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||6.99|4.28|<0.001
71051193|NCT02912650|141608110|SUPERIORITY_OR_OTHER||LS Mean Difference|3.73|||<|0.001|TWO_SIDED|95.0|2.37|5.1|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.10|2.37|<0.001
71051194|NCT02912650|141608110|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9|||<|0.001|TWO_SIDED|95.0|0.95|2.86|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.86|0.95|<0.001
70851129|NCT05111301|141190489|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.001
70931844|NCT02307682|141364343|OTHER||Difference in proportions|8.3|||||TWO_SIDED|95.0|2.0|15.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||15.1|2.0|
71105338|NCT02964377|141718120|EQUIVALENCE|Difference in trough vs. peak values was evaluated using a paired t-test analysis.||||||0.0127|||||||t-test, 2 sided|||||||0.0127
70851130|NCT05111301|141190490|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.01
70851131|NCT05111301|141190491|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.80
70851132|NCT00669409|141190507|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-17.8|13.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.8|-17.8|
70851133|NCT00669409|141190507|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.5|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-34.3|-2.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.8|-34.3|
70854122|NCT01347580|141196306|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.225||||0.0547|TWO_SIDED|95.0|0.996|1.506|||Regression, Logistic|||||1.506|0.996|0.0547
71051195|NCT02912650|141608110|SUPERIORITY_OR_OTHER||LS Mean Difference|8.89|||<|0.001|TWO_SIDED|95.0|7.08|10.71|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||10.71|7.08|<0.001
71051196|NCT02912650|141608110|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0||||0.002|TWO_SIDED|95.0|0.73|3.26|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.26|0.73|0.002
71051197|NCT02912650|141608110|SUPERIORITY_OR_OTHER||LS Mean Difference|4.48|||<|0.001|TWO_SIDED|95.0|3.2|5.77|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.77|3.20|<0.001
71051198|NCT02912650|141608110|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9|||<|0.001|TWO_SIDED|95.0|5.08|8.71|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||8.71|5.08|<0.001
71051199|NCT02912650|141608110|SUPERIORITY_OR_OTHER||LS Mean Difference|4.41|||<|0.001|TWO_SIDED|95.0|2.58|6.24|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||6.24|2.58|<0.001
71051200|NCT02912650|141608110|SUPERIORITY_OR_OTHER||LS Mean Difference|2.49|||<|0.001|TWO_SIDED|95.0|1.21|3.77|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.77|1.21|<0.001
71051201|NCT02912650|141608110|SUPERIORITY_OR_OTHER||LS Mean Difference|10.42|||<|0.001|TWO_SIDED|95.0|7.76|13.08|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||13.08|7.76|<0.001
71051202|NCT02912650|141608110|SUPERIORITY_OR_OTHER||LS Mean Difference|2.14||||0.024|TWO_SIDED|95.0|0.28|4.0|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.00|0.28|0.024
71051203|NCT02912650|141608110|SUPERIORITY_OR_OTHER||LS Mean Difference|5.24|||<|0.001|TWO_SIDED|95.0|3.35|7.12|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||7.12|3.35|<0.001
70851134|NCT00669409|141190507|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-18.5|13.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.1|-18.5|
70851135|NCT00669409|141190507|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.8|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-29.4|1.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.8|-29.4|
71051204|NCT02912650|141608110|SUPERIORITY_OR_OTHER||LS Mean Difference|8.28|||<|0.001|TWO_SIDED|95.0|5.62|10.93|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||10.93|5.62|<0.001
71051205|NCT02912650|141608110|SUPERIORITY_OR_OTHER||LS Mean Difference|5.18|||<|0.001|TWO_SIDED|95.0|2.51|7.86|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||7.86|2.51|<0.001
71051206|NCT02912650|141608110|SUPERIORITY_OR_OTHER||LS Mean Difference|3.1||||0.001|TWO_SIDED|95.0|1.22|4.97|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.97|1.22|0.001
71051207|NCT02912650|141608110|SUPERIORITY_OR_OTHER||LS Mean Difference|2.77|||<|0.001|TWO_SIDED|95.0|1.95|3.59|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.59|1.95|<0.001
70851136|NCT00669409|141190507|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-34.5|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-55.2|-13.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-13.7|-55.2|
71051208|NCT02912650|141608110|SUPERIORITY_OR_OTHER||LS Mean Difference|0.66||||0.023|TWO_SIDED|95.0|0.09|1.24|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.24|0.09|0.023
71051209|NCT02912650|141608110|SUPERIORITY_OR_OTHER||LS Mean Difference|1.66|||<|0.001|TWO_SIDED|95.0|1.07|2.24|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.24|1.07|<0.001
71051210|NCT02912650|141608110|SUPERIORITY_OR_OTHER||LS Mean Difference|2.11|||<|0.001|TWO_SIDED|95.0|1.29|2.92|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.92|1.29|<0.001
71051211|NCT02912650|141608110|SUPERIORITY_OR_OTHER||LS Mean Difference|1.11||||0.008|TWO_SIDED|95.0|0.29|1.94|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.94|0.29|0.008
71051212|NCT02912650|141608110|SUPERIORITY_OR_OTHER||LS Mean Difference|0.99|||<|0.001|TWO_SIDED|95.0|0.41|1.57|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.57|0.41|<0.001
71051213|NCT02912650|141608111|SUPERIORITY_OR_OTHER||LS Mean Difference|3.25|||<|0.001|TWO_SIDED|95.0|2.68|3.82|||ANOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.82|2.68|<0.001
71051214|NCT02912650|141608111|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63||||0.002|TWO_SIDED|95.0|0.23|1.03|||ANOVA|||0-2 hour:Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.03|0.23|0.002
71051215|NCT02912650|141608111|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86|||<|0.001|TWO_SIDED|95.0|0.46|1.27|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.27|0.46|<0.001
71105339|NCT02964377|141718120|EQUIVALENCE|Difference in trough vs. peak values was evaluated using a paired t-test analysis.||||||0.0202|||||||t-test, 2 sided|||||||0.0202
70851137|NCT00669409|141190508|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-19.4|12.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.2|-19.4|
70854123|NCT01347580|141196307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.803||||0.166|TWO_SIDED|95.0|0.588|1.096|||Regression, Logistic|||||1.096|0.588|0.1660
71105340|NCT02964377|141718120|EQUIVALENCE|Difference in trough vs. peak values was evaluated using a paired t-test analysis.||||||0.0007|||||||t-test, 2 sided|||||||0.0007
71105341|NCT02964377|141718121|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4 (Cohort 1)||||<0.0001
71105342|NCT02964377|141718121|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4 (Cohort 2)||||<0.0001
71105343|NCT02964377|141718121|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4 (Cohort 3)||||<0.0001
71105344|NCT02964377|141718121|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8 (Cohort 1)||||<0.0001
71105345|NCT02964377|141718121|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8 (Cohort 2)||||<0.0001
71105346|NCT02964377|141718121|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8 (Cohort 3)||||<0.0001
71105347|NCT02964377|141718124|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.002|||||||Regression, Linear|||Baseline vs. Week 4||||0.002
71105348|NCT02964377|141718124|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.001
71105349|NCT02964377|141718124|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
71017906|NCT01461369|141542797|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.46|STANDARD_ERROR_OF_MEAN|3.385||0.1081|TWO_SIDED|95.0|-12.13|1.21|||ANCOVA|||||1.21|-12.13|0.1081
71017907|NCT04604496|141542800|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|133.17|||||TWO_SIDED|90.0|81.97|216.37||||||Test: the mild hepatic impairment group; Reference: the without hepatic impairment group||216.37|81.97|
71017908|NCT04604496|141542800|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|219.98|||||TWO_SIDED|90.0|135.39|357.41||||||Test: the moderate hepatic impairment Group; Reference: the without hepatic impairment group||357.41|135.39|
71017909|NCT04604496|141542800|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|334.21|||||TWO_SIDED|90.0|205.7|543.0||||||Test: the severe hepatic impairment group; Reference: the without hepatic impairment group||543.00|205.70|
71017910|NCT04604496|141542801|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|122.7|||||TWO_SIDED|90.0|61.33|245.49||||||Test: the mild hepatic impairment group; Reference: the without hepatic impairment group||245.49|61.33|
71017911|NCT04604496|141542801|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|282.73|||||TWO_SIDED|90.0|141.32|565.66||||||Test: the moderate hepatic impairment Group; Reference: the without hepatic impairment group||565.66|141.32|
71017912|NCT04604496|141542801|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|640.78|||||TWO_SIDED|90.0|320.27|1282.0||||||Test: the severe hepatic impairment group; Reference: the without hepatic impairment group||1282.00|320.27|
71017913|NCT04604496|141542802|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|122.89|||||TWO_SIDED|90.0|61.51|245.51||||||Test: the mild hepatic impairment group; Reference: the without hepatic impairment group||245.51|61.51|
71017914|NCT04604496|141542802|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|283.88|||||TWO_SIDED|90.0|142.1|567.13||||||Test: the moderate hepatic impairment Group; Reference: the without hepatic impairment group||567.13|142.10|
71017915|NCT04604496|141542802|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|636.32|||||TWO_SIDED|90.0|318.51|1271.24||||||Test: the severe hepatic impairment group; Reference: the without hepatic impairment group||1271.24|318.51|
71017916|NCT04604496|141542803|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|85.19|||||TWO_SIDED|90.0|63.6|114.1||||||Test: the mild hepatic impairment group; Reference: the without hepatic impairment group||114.10|63.60|
71017917|NCT04604496|141542803|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|96.37|||||TWO_SIDED|90.0|71.95|129.07||||||Test: the moderate hepatic impairment Group; Reference: the without hepatic impairment group||129.07|71.95|
71017918|NCT04604496|141542803|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|135.2|||||TWO_SIDED|90.0|100.94|181.1||||||Test: the severe hepatic impairment group; Reference: the without hepatic impairment group||181.10|100.94|
71017919|NCT02367729|141542809|SUPERIORITY||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|0.3947||0.003|TWO_SIDED|95.0|1.37|2.93|||Wilcoxon (Mann-Whitney)|||||2.93|1.37|0.003
71017920|NCT02742818|141542821|OTHER|||||||0.19|||||||Generalized Estimation Equations (GEE)|Model assuming Gaussian distribution and AR-1 correlation structure, considering repeated measures in time.|||Through inference, changes in body temperature and proportional occurrence of hypothermia during surgery were evaluated using general models of estimating equations (GEE, Liang e Zeger, 1986). Binominal and normal distributions were taken into account, respectively, and assumptions for errors normalities were verified using residual plot graphs and fitted values. The significance of other associated factors and probable outcomes were verified, including gender, age, surgery type and total surgery duration, in minutes. Since analyses were longitudinal, AR-1 working correlation matrix was created.|||0.190
71017921|NCT02742818|141542822|OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.820
71017922|NCT02742818|141542823|OTHER|||||||0.529|||||||Chi-squared|||||||0.529
71017923|NCT02742818|141542824|OTHER|||||||0.999|||||||Chi-squared|||||||0.999
71017924|NCT02742818|141542825|OTHER|||||||0.462|||||||Wilcoxon (Mann-Whitney)|||||||0.462
71017925|NCT04854707|141542840|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71017926|NCT04854707|141542840|OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
70851138|NCT00669409|141190508|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.0|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-30.8|0.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.8|-30.8|
71017927|NCT04854707|141542841|OTHER||Mean Difference (Final Values)|0.017||||0.314|TWO_SIDED|95.0|-0.0161|0.0501|||Chi-squared|z-value = 1||95% Confidence intervals (CIs) of point estimates were calculated using the exact binominal distribution (Clopper-Pearson method) for proportions||0.0501|-0.0161|0.314
71017928|NCT04854707|141542841|OTHER||Mean Difference (Final Values)|0.0207||||0.482|TWO_SIDED|95.0|-0.0369|0.0782|||Chi-squared|||95% Confidence intervals (CIs) of point estimates were calculated using the exact binominal distribution (Clopper-Pearson method) for proportions||0.0782|-0.0369|0.482
71017929|NCT04854707|141542842|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70851139|NCT00669409|141190508|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|4.1|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-11.7|19.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||19.9|-11.7|
71017930|NCT04854707|141542842|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71017931|NCT04854707|141542843|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71017932|NCT04854707|141542844|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71017933|NCT04854707|141542844|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71017934|NCT04007406|141542848|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0||||The threshold value for statistical significance was p\<0.05|Mixed Models Analysis|||||||<0.0001
71017935|NCT04007406|141542849|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0||||The threshold for significance was p \<0.05|Mixed Models Analysis|||||||<0.0001
71017936|NCT04007406|141542850|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0||||The threshold for significance was p \<0.05|Mixed Models Analysis|||||||<0.0001
71051216|NCT02912650|141608111|SUPERIORITY_OR_OTHER||LS Mean Difference|2.62|||<|0.001|TWO_SIDED|95.0|2.05|3.19|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.19|2.05|<0.001
71051217|NCT02912650|141608111|SUPERIORITY_OR_OTHER||LS Mean Difference|2.39|||<|0.001|TWO_SIDED|95.0|1.81|2.96|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.96|1.81|<0.001
71051218|NCT02912650|141608111|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.258|TWO_SIDED|95.0|-0.17|0.64|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.64|-0.17|0.258
71051219|NCT02912650|141608111|SUPERIORITY_OR_OTHER||LS Mean Difference|10.77|||<|0.001|TWO_SIDED|95.0|8.79|12.74|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||12.74|8.79|<0.001
71051220|NCT02912650|141608111|SUPERIORITY_OR_OTHER||LS Mean Difference|2.29||||0.001|TWO_SIDED|95.0|0.91|3.67|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.67|0.91|0.001
71051221|NCT02912650|141608111|SUPERIORITY_OR_OTHER||LS Mean Difference|5.33|||<|0.001|TWO_SIDED|95.0|3.93|6.73|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||6.73|3.93|<0.001
71051222|NCT02912650|141608111|SUPERIORITY_OR_OTHER||LS Mean Difference|8.48|||<|0.001|TWO_SIDED|95.0|6.51|10.44|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||10.44|6.51|<0.001
71105350|NCT02964377|141718124|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
70851140|NCT00669409|141190508|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-26.6|4.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.6|-26.6|
71017937|NCT04007406|141542851|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0||||The threshold for significance was p \<0.05|Mixed Models Analysis|||||||<0.0001
71017938|NCT04007406|141542852|SUPERIORITY||||||<|0.0001||||||The statistical threshold was p\<0.05|Mixed Models Analysis|||||||<0.0001
71017939|NCT05674721|141542854|EQUIVALENCE|The bioequivalence between Treatment A (test) and Treatment B (reference) under fasted conditions would be declared as per Food and Drug Administration (FDA) requirements if the 90 percent (%) confidence intervals (CIs) for the ratio of the geometric means of Cmax were between 80% and 125%.|Ratio of Geometric Least Square Mean|95.13|||||TWO_SIDED|90.0|88.31|102.47||||||||102.47|88.31|
71017940|NCT05674721|141542855|EQUIVALENCE|The bioequivalence between Treatment A (test) and Treatment B (reference) under fasted conditions would be declared as per FDA if the 90% CIs for the ratio of the geometric means of Cmax were between 80% and 125%.|Ratio of Geometric Least Square Mean|102.51|||||TWO_SIDED|90.0|93.54|112.35||||||||112.35|93.54|
71017941|NCT05674721|141542856|EQUIVALENCE|The bioequivalence between Treatment A (test) and Treatment B (reference) under fasted conditions would be declared as per FDA if the 90% CIs for the ratio of the geometric means of AUC0-t were between 80% and 125%.|Ratio of Geometric Least Square Mean|99.15|||||TWO_SIDED|90.0|96.76|101.61||||||||101.61|96.76|
71017942|NCT05674721|141542857|EQUIVALENCE|The bioequivalence between Treatment A (test) and Treatment B (reference) under fasted conditions would be declared as per FDA if the 90% CIs for the ratio of the geometric means of AUC0-t were between 80% and 125%.|Ratio of Geometric Least Square Mean|102.62|||||TWO_SIDED|90.0|98.15|107.3||||||||107.30|98.15|
71017943|NCT05674721|141542858|EQUIVALENCE|The bioequivalence between Treatment A (test) and Treatment B (reference) under fasted conditions would be declared as per FDA if the 90% CIs for the ratio of the geometric means of AUC0-inf were between 80% and 125%.|Ratio of Geometric Least Square Mean|99.2|||||TWO_SIDED|90.0|96.82|101.63||||||||101.63|96.82|
71017944|NCT05674721|141542859|EQUIVALENCE|The bioequivalence between Treatment A (test) and Treatment B (reference) under fasted conditions would be declared as per FDA if the 90% CIs for the ratio of the geometric means of AUC0-inf were between 80% and 125%.|Ratio of Geometric Least Square Mean|102.73|||||TWO_SIDED|90.0|98.31|107.34||||||||107.34|98.31|
71017945|NCT00091507|141542881|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.28|TWO_SIDED|95.0|0.66|1.13|||Regression, Logistic|||||1.13|0.66|0.28
71017946|NCT00091507|141542882|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.08|TWO_SIDED|95.0|0.3|1.07|||Regression, Logistic|||||1.07|0.30|0.08
71017947|NCT00091507|141542883|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.24|TWO_SIDED|95.0|0.43|1.23|||Regression, Logistic|||||1.23|0.43|0.24
71017948|NCT00091507|141542884|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.27|TWO_SIDED|95.0|0.4|1.29|||Regression, Logistic|||||1.29|0.40|0.27
71017949|NCT00091507|141542885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48||||0.01|TWO_SIDED|95.0|0.27|0.85|||Regression, Logistic|||||0.85|0.27|0.01
71017950|NCT01393626|141542908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.86||||0.3249|TWO_SIDED|95.0|-7.64|21.36|||Cochran-Mantel-Haenszel|||Tofacitinib-Placebo||21.36|-7.64|0.3249
71017951|NCT01393626|141542908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.36||||0.3916|TWO_SIDED|95.0|-8.09|20.8|||Cochran-Mantel-Haenszel|||Tofacitinib-Placebo||20.80|-8.09|0.3916
71017952|NCT03506425|141542928|OTHER|||||||0.32|||||||t-test, 2 sided|||||||0.32
71017953|NCT03506425|141542929|OTHER|||||||0.08|||||||ANOVA|||||||0.08
71017954|NCT03506425|141542930|OTHER|||||||0.83|||||||ANOVA|||||||0.83
71017955|NCT02643394|141542933|SUPERIORITY|||||||0.252|TWO_SIDED|80.0|||||Wilcoxon (Mann-Whitney)|||||||0.252
71017956|NCT02643394|141542934|SUPERIORITY|||||||0.402|||||||Wilcoxon (Mann-Whitney)|||||||0.402
70851141|NCT00669409|141190508|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.8|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-30.5|10.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.9|-30.5|
71017957|NCT04193033|141542957|SUPERIORITY|||||||0.001|||||||Linear Growth Curve Model|||||||0.001
71017958|NCT04193033|141542958|SUPERIORITY|||||||0.012|||||||t-test, 2 sided|||||||0.012
71017959|NCT04193033|141542959|SUPERIORITY|||||||0.66|||||||ANOVA|||||||0.66
71017960|NCT04193033|141542961|SUPERIORITY|||||||0.49|||||||Linear Growth Curve Model|Time was included as a fixed effect and both time and intercept were included as random effects.||||||.49
71017961|NCT04193033|141542963|SUPERIORITY|||||||0.06||||||Paired t-test, alpha = .05.|t-test, 2 sided|||||||0.06
71051223|NCT02912650|141608111|SUPERIORITY_OR_OTHER||LS Mean Difference|5.44|||<|0.001|TWO_SIDED|95.0|3.46|7.42|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||7.42|3.46|<0.001
71051224|NCT02912650|141608111|SUPERIORITY_OR_OTHER||LS Mean Difference|3.04|||<|0.001|TWO_SIDED|95.0|1.65|4.43|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.43|1.65|<0.001
71051225|NCT02912650|141608111|SUPERIORITY_OR_OTHER||LS Mean Difference|14.68|||<|0.001|TWO_SIDED|95.0|10.74|18.62|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||18.62|10.74|<0.001
71105351|NCT02964377|141718124|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
71017962|NCT00609115|141542964|SUPERIORITY||Effect size|0.65||||0.01|TWO_SIDED|97.5|||||ANCOVA|||||||0.010
71017963|NCT00609115|141542964|SUPERIORITY||Effect|0.71||||0.003|TWO_SIDED|95.0|||||ANCOVA|||||||0.003
71017964|NCT00609115|141542965|SUPERIORITY||Effect Size|0.0||||1|TWO_SIDED|95.0||||The reported p-value was calculated.|ANCOVA|||||||1.00
71017965|NCT00609115|141542965|SUPERIORITY||Effect Size|-0.29||||0.06|TWO_SIDED|95.0|||||ANCOVA|||||||0.06
71017966|NCT00609115|141542966|SUPERIORITY||Effect Size|0.33||||0.17|TWO_SIDED|95.0|||||ANCOVA|||||||0.17
71017967|NCT00609115|141542966|SUPERIORITY||Effect Size|0.4||||0.17|TWO_SIDED|95.0|||||ANCOVA|||||||0.17
71017968|NCT00609115|141542967|SUPERIORITY||Effect Size|0.05||||0.83|TWO_SIDED|95.0|||||ANCOVA|||||||0.83
71017969|NCT00609115|141542967|SUPERIORITY||Effect Size|-0.27||||0.83|TWO_SIDED|95.0|||||ANCOVA|||||||0.83
71017970|NCT00609115|141542968|SUPERIORITY||Effect Size|0.25||||0.28|TWO_SIDED|95.0|||||ANCOVA|||||||0.28
71017971|NCT00609115|141542968|SUPERIORITY||Effect Size|0.38||||0.09|TWO_SIDED|95.0|||||ANCOVA|||||||0.09
71017972|NCT00609115|141542969|SUPERIORITY||Effect Size|0.23||||0.18|TWO_SIDED|95.0|||||ANCOVA|||||||0.18
71017973|NCT00609115|141542969|SUPERIORITY||Effect Size|0.37||||0.1|TWO_SIDED|95.0|||||ANCOVA|||||||0.10
71017974|NCT00609115|141542970|SUPERIORITY||Effect Size|0.18||||0.45|TWO_SIDED|95.0|||||ANCOVA|||||||0.45
71017975|NCT00609115|141542970|SUPERIORITY||Effect Size|0.71||||0.003|TWO_SIDED|95.0|||||ANCOVA|||||||0.003
71017976|NCT00609115|141542971|SUPERIORITY||Effect Size|-0.17||||0.47|TWO_SIDED|95.0|||||ANCOVA|||||||0.47
71017977|NCT00609115|141542971|SUPERIORITY||Effect Size|0.77||||0.015|TWO_SIDED|95.0|||||ANCOVA|||||||0.015
71017978|NCT00609115|141542972|SUPERIORITY||Effect Size|0.48||||0.05|TWO_SIDED|95.0|||||ANCOVA|||||||0.05
71017979|NCT00609115|141542972|SUPERIORITY||Effect Size|0.56||||0.002|TWO_SIDED|95.0|||||ANCOVA|||||||0.002
71017980|NCT00609115|141542973|SUPERIORITY||Effect Size|0.26||||0.27|TWO_SIDED|95.0|||||ANCOVA|||||||0.27
71017981|NCT00609115|141542973|SUPERIORITY||Effect Size|0.45||||0.045|TWO_SIDED|95.0|||||ANCOVA|||||||0.045
71017982|NCT03083639|141542974|EQUIVALENCE|The bioequivalence between esomeprazole capsules (Regimen A) and esomeprazole tablets (Regimen B) was assessed for the natural logarithms of AUC∞ using analysis of variance (ANOVA) models. The models included regimen, period, and sequence as fixed effects and participant nested within sequence as a random effect. Within ANOVA framework, point estimates and their 90 percent (%) confidence intervals (CIs) for the ratio of AUC central values between esomeprazole capsules and tablets are presented.|Point estimate|1.018|||||TWO_SIDED|90.0|0.969|1.07||||||||1.070|0.969|
71017983|NCT03083639|141542975|EQUIVALENCE|The bioequivalence between esomeprazole capsules (Regimen A) and esomeprazole tablets (Regimen B) was assessed for the natural logarithms of AUCt using ANOVA models. The models included regimen, period, and sequence as fixed effects and participant nested within sequence as a random effect. Within ANOVA framework, point estimates and their 90% CIs for the ratio of AUC central values between esomeprazole capsules and tablets are presented.|Point estimate|0.993|||||TWO_SIDED|90.0|0.939|1.05||||||||1.050|0.939|
71017984|NCT03083639|141542976|EQUIVALENCE|The bioequivalence between esomeprazole capsules (Regimen A) and esomeprazole tablets (Regimen B) was assessed for the natural logarithms of Cmax using ANOVA models. The models included regimen, period, and sequence as fixed effects and participant nested within sequence as a random effect. Within ANOVA framework, point estimates and their 90% CIs for the ratio of Cmax central values between esomeprazole capsules and tablets are presented.|Point estimate|0.942|||||TWO_SIDED|90.0|0.88|1.009||||||||1.009|0.880|
71051226|NCT02912650|141608111|SUPERIORITY_OR_OTHER||LS Mean Difference|3.16||||0.024|TWO_SIDED|95.0|0.41|5.91|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.91|0.41|0.024
71051227|NCT02912650|141608111|SUPERIORITY_OR_OTHER||LS Mean Difference|7.94|||<|0.001|TWO_SIDED|95.0|5.15|10.73|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||10.73|5.15|<0.001
71051228|NCT02912650|141608111|SUPERIORITY_OR_OTHER||LS Mean Difference|11.52|||<|0.001|TWO_SIDED|95.0|7.59|15.45|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||15.45|7.59|<0.001
71051229|NCT02912650|141608111|SUPERIORITY_OR_OTHER||LS Mean Difference|6.75|||<|0.001||95.0|2.79|10.71|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||10.71|2.79|<0.001
71051230|NCT02912650|141608111|SUPERIORITY_OR_OTHER||LS Mean Difference|4.78|||<|0.001|TWO_SIDED|95.0|2.0|7.56|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||7.56|2.0|<0.001
71105352|NCT02964377|141718124|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
71105353|NCT02964377|141718125|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
71105354|NCT02964377|141718125|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
71051231|NCT02912650|141608112|SUPERIORITY_OR_OTHER||LS Mean Difference|5.37|||<|0.001|TWO_SIDED|95.0|4.42|6.32|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||6.32|4.42|<0.001
71051232|NCT02912650|141608112|SUPERIORITY_OR_OTHER||LS Mean Difference|1.07||||0.002|TWO_SIDED|95.0|0.4|1.74|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.74|0.40|0.002
71051233|NCT02912650|141608112|SUPERIORITY_OR_OTHER||LS Mean Difference|1.45|||<|0.001|TWO_SIDED|95.0|0.77|2.13|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.13|0.77|<0.001
71051234|NCT02912650|141608112|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3|||<|0.001|TWO_SIDED|95.0|3.35|5.25|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.25|3.35|<0.001
71051235|NCT02912650|141608112|SUPERIORITY_OR_OTHER||LS Mean Difference|3.92|||<|0.001|TWO_SIDED|95.0|2.96|4.88|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.88|2.96|<0.001
71051236|NCT02912650|141608112|SUPERIORITY_OR_OTHER||LS Mean Difference|0.38||||0.268|TWO_SIDED|95.0|-0.29|1.05|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.05|-0.29|0.268
71051237|NCT02912650|141608112|SUPERIORITY_OR_OTHER||LS Mean Difference|17.99|||<|0.001|TWO_SIDED|95.0|14.69|21.28|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||21.28|14.69|<0.001
71051238|NCT02912650|141608112|SUPERIORITY_OR_OTHER||LS Mean Difference|3.87|||<|0.001|TWO_SIDED|95.0|1.57|6.17|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||6.17|1.57|<0.001
71051239|NCT02912650|141608112|SUPERIORITY_OR_OTHER||LS Mean Difference|8.81|||<|0.001|TWO_SIDED|95.0|6.48|11.15|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||11.15|6.48|<0.001
71051240|NCT02912650|141608112|SUPERIORITY_OR_OTHER||LS Mean Difference|14.12|||<|0.001|TWO_SIDED|95.0|10.83|17.4|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||17.40|10.83|<0.001
71105355|NCT02964377|141718125|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
71105356|NCT02964377|141718125|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
71105357|NCT02964377|141718125|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
71105358|NCT02964377|141718125|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
71105359|NCT02964377|141718126|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
71105360|NCT02964377|141718126|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
71105361|NCT02964377|141718126|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
71105362|NCT02964377|141718126|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
71105363|NCT02964377|141718126|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
71105364|NCT02964377|141718126|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
71105365|NCT02964377|141718127|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.012|||||||Regression, Linear|||Baseline vs. Week 4||||0.012
71051241|NCT02912650|141608112|SUPERIORITY_OR_OTHER||LS Mean Difference|9.17|||<|0.001|TWO_SIDED|95.0|5.86|12.48|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||12.48|5.86|<0.001
71051242|NCT02912650|141608112|SUPERIORITY_OR_OTHER||LS Mean Difference|4.94|||<|0.001|TWO_SIDED|95.0|2.62|7.27|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||7.27|2.62|<0.001
71051243|NCT02912650|141608112|SUPERIORITY_OR_OTHER||LS Mean Difference|21.94|||<|0.001|TWO_SIDED|95.0|17.52|26.37|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||26.37|17.52|<0.001
71051244|NCT02912650|141608112|SUPERIORITY_OR_OTHER||LS Mean Difference|5.0||||0.002|TWO_SIDED|95.0|1.91|8.09|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||8.09|1.91|0.002
71051245|NCT02912650|141608112|SUPERIORITY_OR_OTHER||LS Mean Difference|11.43|||<|0.001|TWO_SIDED|95.0|8.29|14.56|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||14.56|8.29|<0.001
71051246|NCT02912650|141608112|SUPERIORITY_OR_OTHER||LS Mean Difference|16.94|||<|0.001|TWO_SIDED|95.0|12.53|21.36|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||21.36|12.53|<0.001
71051247|NCT02912650|141608112|SUPERIORITY_OR_OTHER||LS Mean Difference|10.52|||<|0.001|TWO_SIDED|95.0|6.07|14.97|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||14.97|6.07|<0.001
71051248|NCT02912650|141608112|SUPERIORITY_OR_OTHER||LS Mean Difference|6.43|||<|0.001|TWO_SIDED|95.0|3.3|9.55|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||9.55|3.30|<0.001
70851142|NCT00669409|141190509|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-19.4|12.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.2|-19.4|
71051249|NCT02912650|141608112|SUPERIORITY_OR_OTHER||LS Mean Difference|25.1|||<|0.001|TWO_SIDED|95.0|18.57|31.63|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||31.63|18.57|<0.001
71051250|NCT02912650|141608112|SUPERIORITY_OR_OTHER||LS Mean Difference|5.3||||0.023|TWO_SIDED|95.0|0.74|9.86|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||9.86|0.74|0.023
71051251|NCT02912650|141608112|SUPERIORITY_OR_OTHER||LS Mean Difference|13.17|||<|0.001|TWO_SIDED|95.0|8.55|17.8|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||17.80|8.55|<0.001
71051252|NCT02912650|141608112|SUPERIORITY_OR_OTHER||LS Mean Difference|19.8|||<|0.001|TWO_SIDED|95.0|13.28|26.31|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||26.31|13.28|<0.001
71051253|NCT02912650|141608112|SUPERIORITY_OR_OTHER||LS Mean Difference|11.93|||<|0.001|TWO_SIDED|95.0|5.36|18.49|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||18.49|5.36|<0.001
71105366|NCT02964377|141718127|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
71051254|NCT02912650|141608112|SUPERIORITY_OR_OTHER||LS Mean Difference|7.87|||<|0.001|TWO_SIDED|95.0|3.27|12.48|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||12.48|3.27|<0.001
71051255|NCT02912650|141608112|SUPERIORITY_OR_OTHER||LS Mean Difference|6.61|||<|0.001|TWO_SIDED|95.0|4.61|8.62|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||8.62|4.61|<0.001
71051256|NCT02912650|141608112|SUPERIORITY_OR_OTHER||LS Mean Difference|1.74||||0.015|TWO_SIDED|95.0|0.34|3.14|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.14|0.34|0.015
71051257|NCT02912650|141608112|SUPERIORITY_OR_OTHER||LS Mean Difference|4.34|||<|0.001|TWO_SIDED|95.0|2.92|5.76|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.76|2.92|<0.001
71051258|NCT02912650|141608112|SUPERIORITY_OR_OTHER||LS Mean Difference|4.87|||<|0.001|TWO_SIDED|95.0|2.87|6.88|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||6.88|2.87|<0.001
71051259|NCT02912650|141608112|SUPERIORITY_OR_OTHER||LS Mean Difference|2.27||||0.028|TWO_SIDED|95.0|0.25|4.28|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.28|0.25|0.028
71051260|NCT02912650|141608112|SUPERIORITY_OR_OTHER||LS Mean Difference|2.61|||<|0.001|TWO_SIDED|95.0|1.19|4.02|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.02|1.19|<0.001
71051261|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-36.56|||<|0.001|TWO_SIDED|95.0|-49.41|-23.71|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-23.71|-49.41|<0.001
71051262|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-3.95||||0.086|TWO_SIDED|95.0|-8.45|0.56|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.56|-8.45|0.086
71105367|NCT02964377|141718127|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
71105368|NCT02964377|141718127|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.01|||||||Regression, Linear|||Baseline vs. Week 8||||0.01
71105369|NCT02964377|141718127|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
71105370|NCT02964377|141718127|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
71017985|NCT02125734|141542977|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.081||||0.0017|TWO_SIDED|95.0|0.031|0.13|||ANCOVA|||||0.130|0.031|0.0017
71017986|NCT03940742|141543017|OTHER||Ratio of geometric least squares mean|1.08|||||TWO_SIDED|90.0|0.879|1.32||||||||1.32|0.879|
71017987|NCT03940742|141543017|OTHER||Ratio of geometric least squares mean|0.96|||||TWO_SIDED|90.0|0.79|1.17||||||||1.17|0.790|
71017988|NCT03940742|141543017|OTHER||Ratio of geometric least squares mean|0.852|||||TWO_SIDED|90.0|0.699|1.04||||||||1.04|0.699|
71017989|NCT03940742|141543018|OTHER||Ratio of geometric least squares mean|0.916|||||TWO_SIDED|90.0|0.726|1.16||||||||1.16|0.726|
71017990|NCT03940742|141543018|OTHER||Ratio of geometric least squares mean|1.0|||||TWO_SIDED|90.0|0.802|1.25||||||||1.25|0.802|
71017991|NCT03940742|141543018|OTHER||Ratio of geometric least squares mean|0.972|||||TWO_SIDED|90.0|0.784|1.21||||||||1.21|0.784|
71017992|NCT02032823|141543022|SUPERIORITY||Hazard Ratio (HR)|0.581||||7.3e-06|TWO_SIDED|99.5|0.409|0.816||A multiple testing procedure is employed across the primary and all key secondary endpoints to strongly control overall type I error at 5% (2 sided) accounting for all analysis timepoints.|Log Rank|Log rank test is stratified by chemotherapy type, hormone receptor status, and prior platinum therapy using a pre-specified pooling strategy.|Estimate of the treatment hazard ratio is based on a stratified Cox's Proportional Hazards Model, \<1 indicates a lower risk with olaparib compared with placebo arm. Stratification factors are the same as those used in the stratified log-rank test.|||0.816|0.409|0.0000073
71017993|NCT02032823|141543023|SUPERIORITY||Hazard Ratio (HR)|0.574||||2.57e-05|TWO_SIDED|99.5|0.392|0.831||A multiple testing procedure is employed across the primary and all key secondary endpoints to strongly control overall type I error at 5% (2 sided) accounting for all analysis timepoints.|Log Rank|Log rank test is stratified by chemotherapy type, hormone receptor status, and prior platinum therapy using a pre-specified pooling strategy.|Estimate of the treatment hazard ratio is based on a stratified Cox's Proportional Hazards Model, \<1 indicates a lower risk with olaparib compared with placebo arm. Stratification factors are the same as those used in the stratified log-rank test.|||0.831|0.392|0.0000257
71017994|NCT02032823|141543024|SUPERIORITY||Hazard Ratio (HR)|0.678||||0.0091|TWO_SIDED|98.5|0.468|0.973||A multiple testing procedure is employed across the primary and all key secondary endpoints to strongly control overall type I error at 5% (2 sided) accounting for all analysis timepoints.|Log Rank|Log rank test is stratified by chemotherapy type, hormone receptor status, and prior platinum therapy using a pre-specified pooling strategy.|Estimate of the treatment hazard ratio is based on a stratified Cox's Proportional Hazards Model, \<1 indicates a lower risk with olaparib compared with placebo arm. Stratification factors are the same as those used in the stratified log-rank test.|||0.973|0.468|0.0091
71017995|NCT03889197|141543030|SUPERIORITY|||||||0.162|||||||Kruskal-Wallis|||||||0.162
71051263|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-3.71||||0.112|TWO_SIDED|95.0|-8.28|0.86|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.86|-8.28|0.112
71105371|NCT02964377|141718129|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.01|||||||Regression, Linear|||Baseline vs. Week 4||||0.01
71017996|NCT03889197|141543031|SUPERIORITY|||||||0.242|||||||Kruskal-Wallis|||||||0.242
71017997|NCT03889197|141543032|SUPERIORITY|||||||0.956|||||||Kruskal-Wallis|||||||0.956
71051264|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-32.52|||<|0.001|TWO_SIDED|95.0|-45.86|-19.17|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-19.17|-45.86|<0.001
71051265|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-32.88|||<|0.001|TWO_SIDED|95.0|-46.22|-19.55|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-19.55|-46.22|<0.001
71017998|NCT03889197|141543033|SUPERIORITY|||||||0.132|||||||Kruskal-Wallis|||||||0.132
71017999|NCT03889197|141543034|SUPERIORITY|||||||0.445|||||||Kruskal-Wallis|||||||0.445
71051266|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|0.11||||0.968|TWO_SIDED|95.0|-5.2|5.42|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||5.42|-5.20|0.968
71051267|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-47.88|||<|0.001|TWO_SIDED|95.0|-61.18|-34.58|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-34.58|-61.18|<0.001
71105372|NCT02964377|141718129|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.019|||||||Regression, Linear|||Baseline vs. Week 4||||0.019
71018000|NCT03889197|141543035|SUPERIORITY|||||||0.746|||||||Kruskal-Wallis|||||||0.746
71018001|NCT03889197|141543036|SUPERIORITY|||||||0.979|||||||Kruskal-Wallis|||||||0.979
71018002|NCT03889197|141543037|SUPERIORITY|||||||0.289|||||||Chi-squared|||||||0.289
71018003|NCT03889197|141543038|SUPERIORITY|||||||0.94|||||||Kruskal-Wallis|||||||0.940
71018004|NCT03889197|141543039|SUPERIORITY|||||||0.126|||||||Chi-squared|||||||0.126
71018005|NCT03889197|141543040|SUPERIORITY|||||||0.738|||||||Fisher Exact|||||||0.738
71018006|NCT03889197|141543041|SUPERIORITY|||||||0.676|||||||Fisher Exact|||||||0.676
71018007|NCT03889197|141543042|SUPERIORITY|||||||0.996|||||||Kruskal-Wallis|||||||0.996
71018008|NCT03889197|141543043|SUPERIORITY|||||||0.095|||||||Kruskal-Wallis|||||||0.095
71105373|NCT02964377|141718129|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.001
71105374|NCT02964377|141718129|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.05|||||||Regression, Linear|||Baseline vs. Week 8||||0.05
71105375|NCT02964377|141718130|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.054||||||p-value for difference at Week 4|Regression, Linear|||Baseline vs. Week 8||||0.054
70931845|NCT02307682|141364343|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-5.2|7.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||7.1|-5.2|
70931846|NCT02307682|141364343|OTHER||Difference in proportions|7.6|||||TWO_SIDED|95.0|0.7|13.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||13.8|0.7|
71018009|NCT03078192|141543093|OTHER|Detecting pre-capillary PH was tested with a cohort of 32 patients. True PH status was based on RHC. A diagnosis of PH was established from mPAP \>20mmHg, while pre-capillary PH required PCWP ≤ 15mmHg and PVR ≥ 3 Woods Units, and post capillary PH required PCWP \> 15mmH and PVR \< 3 Woods Units \[21\]. Patients with both high PVR and PCWP \> 15mmHg were classified as combined pre- and post-capillary PH (CpcPH). Subjects with CpcPH were treated as positive for both pre- and post-capillary PH.|positive predictive value|0.86|||||TWO_SIDED|||||Positive predictive value for Precapillary Pulmonary Hypertension: 86%|calculation of PPV|||||||
71018010|NCT02508649|141543097|SUPERIORITY||Treatment difference|0.55||||0.3015|TWO_SIDED|95.0|-1.34|2.43|||van Elteren test|||The primary endpoint was analyzed using a van Elteren test. The analysis included a test of superiority using a two-sided 5% significance level.||2.43|-1.34|0.3015
71018011|NCT02508649|141543098|SUPERIORITY||Odds Ratio (OR)|1.049||||0.7694|TWO_SIDED|95.0|0.762|1.445|||Regression, Logistic||An odds ratio \< 1 in proportion of subjects dying indicates lower mortality in the selepressin group.|Mortality was analyzed using a logistic regression model with the individual sequential organ failure assessment (SOFA) scores and age as covariates and treatment arm as factor.||1.445|0.762|0.7694
71018012|NCT02508649|141543099|SUPERIORITY||Treatment difference|0.29||||0.8458|TWO_SIDED|95.0|-2.07|2.65|||van Elteren test|||This endpoint was analyzed using a van Elteren test. The analysis was a test of superiority using a two-sided 5% significance level.||2.65|-2.07|0.8458
71018013|NCT02508649|141543100|SUPERIORITY||Treatment difference|0.49||||0.4124|TWO_SIDED|95.0|-1.22|2.19|||van Elteren test|||This endpoint was analyzed using a van Elteren test. The analysis was a test of superiority using a two-sided 5% significance level.||2.19|-1.22|0.4124
71018014|NCT02508649|141543107|OTHER||Treatment difference|-0.51||||0.2009|TWO_SIDED|95.0|-1.3|0.27|||ANCOVA|||Overall score using a modified version of the SOFA on Day 1||0.27|-1.30|0.2009
71018015|NCT02508649|141543107|OTHER||Treatment difference|0.11||||0.7894|TWO_SIDED|95.0|-0.68|0.9|||ANCOVA|||Overall score using a modified version of the SOFA on Day 3||0.90|-0.68|0.7894
71018016|NCT02508649|141543107|OTHER||Treatment difference|0.55||||0.1888|TWO_SIDED|95.0|-0.27|1.37|||ANCOVA|||Overall score using a modified version of the SOFA on Day 7||1.37|-0.27|0.1888
71018017|NCT02508649|141543107|OTHER||Treatment difference|-0.08||||0.2997|TWO_SIDED|95.0|-0.24|0.07|||ANCOVA|||Individual organ (respiratory) score using a modified version of the SOFA on Day 1||0.07|-0.24|0.2997
71018018|NCT02508649|141543107|OTHER||Treatment difference|-0.03||||0.6796|TWO_SIDED|95.0|-0.19|0.12|||ANCOVA|||Individual organ (respiratory) score using a modified version of the SOFA on Day 3||0.12|-0.19|0.6796
71018019|NCT02508649|141543107|OTHER||Treatment difference|0.03||||0.7467|TWO_SIDED|95.0|-0.14|0.19|||ANCOVA|||Individual organ (respiratory) score using a modified version of the SOFA on Day 7||0.19|-0.14|0.7467
71018020|NCT02508649|141543107|OTHER||Treatment difference|-0.42||||0.0003|TWO_SIDED|95.0|-0.65|-0.19|||ANCOVA|||Individual organ (cardiovascular) score using a modified version of the SOFA on Day 1||-0.19|-0.65|0.0003
71018021|NCT02508649|141543107|OTHER||Treatment difference|-0.25||||0.0349|TWO_SIDED|95.0|-0.49|-0.02|||ANCOVA|||Individual organ (cardiovascular) score using a modified version of the SOFA on Day 3||-0.02|-0.49|0.0349
71018022|NCT02508649|141543107|OTHER||Treatment difference|-0.14||||0.2787|TWO_SIDED|95.0|-0.39|0.11|||ANCOVA|||Individual organ (cardiovascular) score using a modified version of the SOFA on Day 7||0.11|-0.39|0.2787
71018023|NCT02508649|141543107|OTHER||Treatment difference|-0.05||||0.6476|TWO_SIDED|95.0|-0.26|0.16|||ANCOVA|||Individual organ (renal) score using a modified version of the SOFA on Day 1||0.16|-0.26|0.6476
71018024|NCT02508649|141543107|OTHER||Treatment difference|0.08||||0.4313|TWO_SIDED|95.0|-0.13|0.29|||ANCOVA|||Individual organ (renal) score using a modified version of the SOFA on Day 3||0.29|-0.13|0.4313
71018025|NCT02508649|141543107|OTHER||Treatment difference|0.17||||0.1334|TWO_SIDED|95.0|-0.05|0.39|||ANCOVA|||Individual organ (renal) score using a modified version of the SOFA on Day 7||0.39|-0.05|0.1334
71018026|NCT02508649|141543107|OTHER||Treatment difference|0.12||||0.2126|TWO_SIDED|95.0|-0.07|0.3|||ANCOVA|||Individual organ (coagulation) score using a modified version of the SOFA on Day 1||0.30|-0.07|0.2126
71018027|NCT02508649|141543107|OTHER||Treatment Difference|0.23||||0.0174|TWO_SIDED|95.0|0.04|0.41|||ANCOVA|||Individual organ (coagulation) score using a modified version of the SOFA on Day 3||0.41|0.04|0.0174
71018028|NCT02508649|141543107|OTHER||Treatment difference|0.23||||0.0194|TWO_SIDED|95.0|0.04|0.43|||ANCOVA|||Individual organ (coagulation) score using a modified version of the SOFA on Day 7||0.43|0.04|0.0194
71018029|NCT02508649|141543107|OTHER||Treatment difference|-0.15||||0.1284|TWO_SIDED|95.0|-0.35|0.04|||ANCOVA|||Individual organ (liver) score using a modified version of the SOFA on Day 1||0.04|-0.35|0.1284
71018030|NCT02508649|141543107|OTHER||Treatment difference|-0.05||||0.6542|TWO_SIDED|95.0|-0.25|0.15|||ANCOVA|||Individual organ (liver) score using a modified version of the SOFA on Day 3||0.15|-0.25|0.6542
71018031|NCT02508649|141543107|OTHER||Treatment difference|0.17||||0.1079|TWO_SIDED|95.0|-0.04|0.38|||ANCOVA|||Individual organ (liver) score using a modified version of the SOFA on Day 7||0.38|-0.04|0.1079
71018032|NCT02508649|141543108|OTHER||Odds Ratio (OR)|1.4||||0.063|TWO_SIDED|95.0|0.98|2.0|||Regression, Logistic||Odds ratio is equal to Selepressin pooled/Placebo.|Percentage of subjects with new organ dysfunction up to Day 7||2.00|0.98|0.0630
71018033|NCT02508649|141543108|OTHER||Odds Ratio (OR)|1.28||||0.1875|TWO_SIDED|95.0|0.89|1.86|||Regression, Logistic||Odds ratio is equal to Selepressin pooled/Placebo.|Percentage of subjects with new organ dysfunction up to Day 30||1.86|0.89|0.1875
71018034|NCT02508649|141543108|OTHER||Odds Ratio (OR)|1.14||||0.4382|TWO_SIDED|95.0|0.82|1.58|||Regression, Logistic||Odds ratio is equal to Selepressin pooled/Placebo.|Percentage of subjects with new organ failure up to Day 7||1.58|0.82|0.4382
71105376|NCT02964377|141718130|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.009|||||||Regression, Linear|||Baseline vs. Week 4||||0.009
71105377|NCT02964377|141718131|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.025|||||||Regression, Linear|||Baseline vs. Week 8||||0.025
71105378|NCT02964377|141718131|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.026|||||||Regression, Linear|||Baseline vs. Week 4||||0.026
71105379|NCT02964377|141718132|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.006|||||||Regression, Linear|||Baseline vs. Week 4||||0.006
71105380|NCT02964377|141718132|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.002|||||||Regression, Linear|||Baseline vs. Week 8||||0.002
71105381|NCT03674281|141718168|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||0.002
71105382|NCT03674281|141718168|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71105383|NCT00710593|141718172|SUPERIORITY_OR_OTHER||% of participants who were responders|97.5||||0.1613|TWO_SIDED|95.0|86.8|99.9|||Fisher Exact|||Historical comparison group can be referenced in: Villa et al. Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18; Vaccine 24 (2006):5571-5583. PMID 16753240.||99.9|86.8|0.1613
70931847|NCT02307682|141364343|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-6.8|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||6.1|-6.8|
70931848|NCT02307682|141364343|OTHER||Difference in proportions|8.2|||||TWO_SIDED|95.0|2.2|15.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||15.0|2.2|
71105384|NCT00710593|141718173|SUPERIORITY_OR_OTHER||% of participants who were responders|96.8||||0.0534|TWO_SIDED|95.0|89.0|99.9|||Fisher Exact|||Historical comparison group can be referenced in: Villa et al. Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18; Vaccine 24 (2006):5571-5583. PMID 16753240.||99.9|89.0|0.0534
71105385|NCT00710593|141718174|SUPERIORITY_OR_OTHER||% of participants who were responders|96.1||||0.0427|TWO_SIDED|95.0|86.5|99.5|||Fisher Exact|||Historical comparison group can be referenced in: Villa et al. Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18; Vaccine 24 (2006):5571-5583. PMID 16753240.||99.5|86.5|0.0427
70931849|NCT02307682|141364343|OTHER||Difference in proportions|2.8|||||TWO_SIDED|95.0|-3.9|9.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||9.2|-3.9|
70931850|NCT02307682|141364343|OTHER||Difference in proportions|4.8|||||TWO_SIDED|95.0|-1.5|11.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||11.4|-1.5|
71018035|NCT02508649|141543108|OTHER||Odds Ratio (OR)|1.01||||0.9529|TWO_SIDED|95.0|0.73|1.39|||Regression, Logistic||Odds ratio is equal to Selepressin pooled/Placebo.|Percentage of subjects with new organ failure up to Day 30||1.39|0.73|0.9529
71105386|NCT00710593|141718175|SUPERIORITY_OR_OTHER||% of participants who were responders|92.5||||0.0006|TWO_SIDED|95.0|83.4|97.5|||Fisher Exact|||Historical comparison group can be referenced in: Villa et al. Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18; Vaccine 24 (2006):5571-5583. PMID 16753240.||97.5|83.4|0.0006
71105387|NCT00710593|141718176|SUPERIORITY_OR_OTHER||% of participants with at least 1 event|49.3||||0.8305|TWO_SIDED|95.0||||The p-value is to test the proportions of subjects with at least one event among Group A during the study at Entry, Week 8 and Week 24 after vaccine was administered.|Chi-squared, Corrected|||||||0.8305
71105388|NCT00710593|141718176|SUPERIORITY_OR_OTHER||% of participants with at least 1 event|46.7||||0.8305|TWO_SIDED|||||The p-value is to test the proportions of subjects with at least one event among Group B during the study at Entry, Week 8 and Week 24 after vaccine was administered.|Chi-squared, Corrected|||||||0.8305
71105389|NCT00710593|141718184|SUPERIORITY_OR_OTHER||Overall aquisition rate|7.9||||1||95.0|||||Fisher Exact|P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.||||||1.000
71105390|NCT00710593|141718185|SUPERIORITY_OR_OTHER||Overall aquisition rate|1.6||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
71105391|NCT00710593|141718186|SUPERIORITY_OR_OTHER||Overall aquisition rate|2.0||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
71105392|NCT00710593|141718187|SUPERIORITY_OR_OTHER||Overall aquisition rate|4.5||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
71105393|NCT00710593|141718188|SUPERIORITY_OR_OTHER||Overall aquisition rate|8.3||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
71105394|NCT00710593|141718189|SUPERIORITY_OR_OTHER||Overall aquistion rate|3.6||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
71105395|NCT00710593|141718190|SUPERIORITY_OR_OTHER||Overall aquisition rate|6.3||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
70931851|NCT02307682|141364343|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-5.9|7.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||7.1|-5.9|
71018036|NCT00417859|141543119|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||FB group was designated the control group. We determined a sample size based in clinical criteria. Using an α of 0.05 and β of 0.8, the required sample size was calculated to be 24 patients in each group to achieve a power of 80%. Descriptive analysis was completed on demographic information and clinical and radiological outcomes. Nonparametric tests (Wilcoxon's signed ranks or rank sum tests) were used for comparison of scores. The chi-squared test was used for dichotomous variables.||||0.05
71018037|NCT03594175|141543131|SUPERIORITY||Mean difference of proportions, Wald|29.51||||0.003|TWO_SIDED|95.0|10.76|48.26|||2-sample Z test for proportions|||CUSA-081 vs Placebo Dwell Time Up To 90 Min -- FAS||48.26|10.76|0.003
71018038|NCT03594175|141543132|NON_INFERIORITY|Non-inferiority was assessed based on the constructed 95% confidence interval (CI) for the difference in the rate of treatment success between CUSA-081 vs alteplase, with non-inferiority considered as demonstrated if the lower limit of the 95% CI for the difference in rate of success is greater than -10%.|Mean difference of proportions, Wald|-10.31||||0.03|TWO_SIDED|95.0|-19.38|-1.24|||2-sample Z test for proportions|||||-1.24|-19.38|0.030
71018039|NCT03594175|141543133|SUPERIORITY||Mean difference of proportions, Wald|24.13||||0.017|TWO_SIDED|95.0|5.84|42.41|||2-sample Z test for proportions|||||42.41|5.84|0.017
71018040|NCT03594175|141543134|SUPERIORITY||Mean difference of proportions, Wald|41.08|||<|0.001|TWO_SIDED|95.0|21.94|60.21|||2-sample Z test for proportions|||||60.21|21.94|<0.001
71018041|NCT03594175|141543135|SUPERIORITY||Mean difference of proportions, Wald|-10.96||||0.019|TWO_SIDED|95.0|-19.89|-2.04|||2-sample Z test for proportions|||||-2.04|-19.89|0.019
71018042|NCT03594175|141543136|SUPERIORITY||Probability Re-Occlusion Free at Day 30|0.948|||||TWO_SIDED|95.0|0.126|7.121||||||Time to first re-occlusion.||7.121|0.126|
71018043|NCT03594175|141543136|OTHER||Cox Proportional Hazard|0.654|||||TWO_SIDED|95.0|0.337|1.27||||||Time to first re-occlusion.||1.270|0.337|
71018044|NCT03594175|141543136|OTHER||Cox Proportional Hazard|1.448|||||TWO_SIDED|95.0|0.193|10.848||||||Time to first re-occlusion.||10.848|0.193|
71018045|NCT00367679|141543275|SUPERIORITY_OR_OTHER||Percentage of participants with response|5.7||||||95.0|0.7|19.2|||||The estimated value given is the percentage of participants who had a response out of the total participants.|||19.2|0.7|
71018046|NCT00367679|141543276|SUPERIORITY_OR_OTHER||Percentage of participants with response|8.6||||||95.0|1.8|23.1|||||The estimated value given is the percentage of participants who had a response out of the total participants.|||23.1|1.8|
71018047|NCT00367679|141543282|SUPERIORITY_OR_OTHER|||||||0.0028||95.0||||VEGF D|t-test, 2 sided|Post- versus pretreatment expression levels for each of the indicated genes in response to pazopanib treatment||||||0.0028
71018048|NCT00367679|141543282|SUPERIORITY_OR_OTHER|||||||0.0324||95.0||||VEGF A|t-test, 2 sided|Post- versus pretreatment expression levels for each of the indicated genes in response to pazopanib treatment||||||0.0324
71018049|NCT00367679|141543282|SUPERIORITY_OR_OTHER|||||||0.0082||95.0||||VEGFR-2|t-test, 2 sided|Post- versus pretreatment expression levels for each of the indicated genes in response to pazopanib treatment||||||0.0082
71018050|NCT00367679|141543282|SUPERIORITY_OR_OTHER|||||||0.0082||95.0||||c-KIT|t-test, 2 sided|Post- versus pretreatment expression levels for each of the indicated genes in response to pazopanib treatment||||||0.0082
71051268|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-6.23||||0.023|TWO_SIDED|95.0|-11.61|-0.84|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-0.84|-11.61|0.023
71051269|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-6.23||||0.026|TWO_SIDED|95.0|-11.73|-0.73|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-0.73|-11.73|0.026
71018051|NCT00367679|141543288|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Vascular endothelial growth factor receptor 2 (VEGFR2)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||<0.01
71018052|NCT00367679|141543288|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Placental growth factor (PIGF)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||<0.01
71018053|NCT00367679|141543288|SUPERIORITY_OR_OTHER|||||||0.00024||95.0||||Interferon-inducible cytokine (IP-10)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.00024
71018054|NCT00367679|141543288|SUPERIORITY_OR_OTHER|||||||0.0029||95.0||||Cutaneous T-cell attracting chemokine (CTACK)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.0029
71018055|NCT00367679|141543288|SUPERIORITY_OR_OTHER|||||||0.0062||95.0||||Stromal cell-derived factor 1 (SDF-1alpha)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.0062
71018056|NCT00367679|141543288|SUPERIORITY_OR_OTHER|||||||0.0069||95.0||||Monokine induced by interferon gamma (MIG)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.0069
71018057|NCT00367679|141543288|SUPERIORITY_OR_OTHER|||||||0.0093||95.0||||Tumor necrosis factor ligand (TRAIL)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.0093
71018058|NCT00367679|141543288|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||Interferon alpha 2 (IFN-alpha2)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.021
71018059|NCT00367679|141543288|SUPERIORITY_OR_OTHER|||||||0.326||95.0||||Vascular endothelial growth factor (VEGF)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.326
71018060|NCT02953262|141543289|SUPERIORITY|||||||0.057||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.057
71105396|NCT00710593|141718191|SUPERIORITY_OR_OTHER||Overall aquisition rate|8.1||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
71105397|NCT00710593|141718192|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.0004|TWO_SIDED|95.0|1.02|1.1|||Regression, Logistic|||||1.1|1.02|0.0004
71105398|NCT00710593|141718193|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.0012|TWO_SIDED|95.0|1.0|1.1|||Regression, Logistic|||||1.1|1.0|0.0012
71105399|NCT00710593|141718194|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
71105400|NCT01444911|141718237|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89|||||||ANOVA|||||||0.89
70851143|NCT00669409|141190509|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.5|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-34.3|-2.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.8|-34.3|
70851144|NCT00669409|141190509|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-12.6|19.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||19.0|-12.6|
70851145|NCT00669409|141190509|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-25.0|6.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.2|-25.0|
70851146|NCT00669409|141190509|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-25.4|16.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.1|-25.4|
70851147|NCT00669409|141190510|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-18.1|13.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.5|-18.1|
71018061|NCT02953262|141543289|SUPERIORITY|||||||0.753||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.753
71018062|NCT02953262|141543289|SUPERIORITY|||||||0.613||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.613
71018063|NCT02953262|141543290|SUPERIORITY|||||||0.308||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.308
71018064|NCT02953262|141543290|SUPERIORITY|||||||0.154||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.154
71018065|NCT02953262|141543290|SUPERIORITY|||||||0.025||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.025
71018066|NCT02953262|141543291|SUPERIORITY|||||||0.102||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.102
71018067|NCT02953262|141543291|SUPERIORITY|||||||0.023||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.023
71018068|NCT02953262|141543291|SUPERIORITY|||||||0.439||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.439
71018069|NCT02953262|141543292|SUPERIORITY|||||||0.982||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.982
71018070|NCT02953262|141543292|SUPERIORITY|||||||0.559||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.559
71018071|NCT02953262|141543292|SUPERIORITY|||||||0.032||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.032
71018072|NCT03349437|141543337|SUPERIORITY|||||||0.02||||||This p-value is in reference to the total Modified 6MWT Distance|Wilcoxon Signed Rank|||||||0.02
71018073|NCT01563029|141543352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.0|||<|0.001|TWO_SIDED|95.0|9.6|22.4|||ANCOVA|Gate-keeper analysis||||22.4|9.6|<0.001
71018074|NCT01563029|141543352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.5|||<|0.001|TWO_SIDED|95.0|5.1|19.8|||ANCOVA||Inference for FF 100 μg versus (vs) placebo and FF 50 ug versus placebo was dependent upon statistical significance (SS) having first been achieved for the average of the higher two doses of FF (FF 100 ug and 50 ug ) versus placebo comparison.|||19.8|5.1|<0.001
71018075|NCT01563029|141543352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.5|||<|0.001|TWO_SIDED|95.0|12.1|26.9|||ANCOVA||Inference for FF 100 µg versus (vs) placebo and FF 50 ug versus placebo was dependent upon statistical significance (SS) having first been achieved for the average of the higher two doses of FF (FF 100 ug and 50 ug ) versus placebo comparsion.|||26.9|12.1|<0.001
71018076|NCT01563029|141543352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.6|||<|0.001|TWO_SIDED|95.0|11.3|26.0|||ANCOVA||Inference for FF 25 ug versus placebo was dependent upon statistical significance (SS) having first been achieved for both the FF 100 ug versus placebo comparison and the FF 50 ug versus placebocomparison.|||26.0|11.3|<0.001
71018077|NCT01563029|141543352|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|14.0|||<|0.001|TWO_SIDED|95.0|6.7|21.4|||ANCOVA|||||21.4|6.7|<0.001
71018078|NCT01563029|141543353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126|||<|0.001|TWO_SIDED|95.0|0.051|0.201|||ANCOVA|||||0.201|0.051|<0.001
71018079|NCT01563029|141543353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022||||0.551|TWO_SIDED|95.0|-0.05|0.094|||ANCOVA|||||0.094|-0.050|0.551
71018080|NCT01563029|141543353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033||||0.379|TWO_SIDED|95.0|-0.041|0.108|||ANCOVA|||||0.108|-0.041|0.379
71018081|NCT01563029|141543353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064||||0.089|TWO_SIDED|95.0|-0.01|0.137|||ANCOVA|||||0.137|-0.010|0.089
71018082|NCT01563029|141543354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.4||||0.05|TWO_SIDED|95.0|0.0|16.9|||ANCOVA|||||16.9|0.0|0.050
71018083|NCT01563029|141543354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.8||||0.023|TWO_SIDED|95.0|1.3|18.2|||ANCOVA|||||18.2|1.3|0.023
71018084|NCT01563029|141543354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.2||||0.004|TWO_SIDED|95.0|3.8|20.5|||ANCOVA|||||20.5|3.8|0.004
71018085|NCT01563029|141543354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2||||0.143|TWO_SIDED|95.0|-2.1|14.6|||ANCOVA|||||14.6|-2.1|0.143
71018086|NCT01563029|141543355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.2||||0.005|TWO_SIDED|95.0|3.4|19.0|||ANCOVA|||||19.0|3.4|0.005
71018087|NCT01563029|141543355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.4|||<|0.001|TWO_SIDED|95.0|5.7|21.1|||ANCOVA|||||21.1|5.7|<0.001
71105401|NCT00069641|141718245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|18.96|STANDARD_ERROR_OF_MEAN|6.47||0.0049|TWO_SIDED|95.0|5.99|31.93|||ANCOVA|||p-value for treatment difference based on Analysis of covariance (ANCOVA) model containing treatment, region, baseline participant age, and baseline disease score.||31.93|5.99|0.0049
71105402|NCT03186638|141718248|SUPERIORITY|||||||0.7917|||||||ANCOVA|Adjusted for Baseline values||||||0.7917
71105403|NCT01263119|141718249|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.07|||||TWO_SIDED|90.0|1.0|1.13|||Mixed Models Analysis|||||1.13|1.00|
71105404|NCT01263119|141718250|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.12|||||TWO_SIDED|90.0|1.07|1.16|||Mixed Models Analysis|||||1.16|1.07|
71105405|NCT01263119|141718251|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.9551|TWO_SIDED|90.0|-0.5|0.5|||Wilcoxon (Mann-Whitney)|||||0.50|-0.50|0.9551
71105406|NCT01263119|141718252|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.15|||||TWO_SIDED|90.0|1.1|1.2|||Mixed Models Analysis|||||1.20|1.10|
71105407|NCT01263119|141718253|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.13|||||TWO_SIDED|90.0|1.09|1.17|||Mixed Models Analysis|||||1.17|1.09|
71105408|NCT01263119|141718254|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.6094|TWO_SIDED|90.0|-0.5|0.02|||Wilcoxon (Mann-Whitney)|||||0.02|-0.50|0.6094
71105409|NCT01263119|141718255|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|1.02|1.05|||Mixed Models Analysis|||Least Squares (LS) geometric mean was based on pharmacodynamic AUCINR of warfarin.||1.05|1.02|
71105410|NCT01263119|141718256|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|1.01|1.08|||Mixed Models Analysis|||Least Squares (LS) geometric mean was based on pharmacodynamic INRmax of warfarin.||1.08|1.01|
71105411|NCT05067335|141718266|SUPERIORITY||Difference in LSM(Romosozumab - Placebo)|9.37|STANDARD_ERROR_OF_MEAN|0.524|<|0.001|TWO_SIDED|95.0|8.34|10.39|||ANCOVA|||The ANCOVA model was used and included treatment group, Baseline DXA BMD value, machine type (hologic or lunar) at Baseline, age strata group (stratification factor), region, and interaction of Baseline DXA BMD value and machine type at Baseline as independent variables.||10.39|8.34|<0.001
71105412|NCT05067335|141718269|SUPERIORITY||Difference in LSM(Romosozumab - Placebo)|2.86|STANDARD_ERROR_OF_MEAN|0.348|<|0.001|TWO_SIDED|95.0|2.18|3.54|||ANCOVA|||The ANCOVA model was used and included treatment group, Baseline DXA BMD value, machine type (hologic or lunar) at Baseline, age strata group (stratification factor), region, and interaction of Baseline DXA BMD value and machine type at Baseline as independent variables.||3.54|2.18|<0.001
70851148|NCT00669409|141190510|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-17.8|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-33.6|-2.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.1|-33.6|
70851149|NCT00669409|141190510|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-17.2|14.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||14.4|-17.2|
70851150|NCT00669409|141190510|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.2|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-26.7|4.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.4|-26.7|
70851151|NCT00669409|141190510|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-25.8|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-46.5|-5.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-5.0|-46.5|
71105413|NCT05067335|141718270|SUPERIORITY||Difference in LSM(Romosozumab - Placebo)|3.48|STANDARD_ERROR_OF_MEAN|0.458|<|0.001|TWO_SIDED|95.0|2.58|4.38|||ANCOVA|||The ANCOVA model was used and included treatment group, Baseline DXA BMD value, machine type (hologic or lunar) at Baseline, age strata group (stratification factor), region, and interaction of Baseline DXA BMD value and machine type at Baseline as independent variables.||4.38|2.58|<0.001
71105414|NCT00261833|141718274|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|0.618||||0.029|TWO_SIDED|95.0|-0.024|1.261||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira minus placebo (ie, the lower bound of the 95% confidence interval \[CI\] being greater than zero) will indicate superiority of Zemaira compared with Placebo.|95% confidence interval||A mixed model was used to estimate the 95% CI for the difference (Zemaira® - placebo) in annual lung density decline.|Analysis of the annual rate of change in lung density (TLC+FRC combined) was a linear mixed model with country, inspiration state, time since baseline treatment, and treatment-by-time interaction as fixed effects and participant and participant-by-time interaction as random coefficients at a 1-sided significance level of 0.025.||1.261|-0.024|0.029
71105415|NCT00261833|141718274|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|0.74||||0.017|TWO_SIDED|95.0|0.059|1.42||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (ie, the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.|95% confidence interval||A mixed model was used to estimate the 95% CI for the difference (Zemaira® - placebo) in annual lung density decline.|Analysis of the annual rate of change in lung density (TLC) was a linear mixed model with country, time since baseline treatment, and treatment-by-time interaction as fixed effects and participant and participant-by-time interaction as random coefficients at a 1-sided significance level of 0.025.||1.420|0.059|0.017
71105416|NCT00261833|141718274|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|0.478||||0.09|TWO_SIDED|95.0|-0.223|1.18||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (ie, the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.|95% confidence interval||A mixed model was used to estimate the 95% CI for the difference (Zemaira® - placebo) in annual lung density decline.|Analysis of the annual rate of change in lung density (FRC) was a linear mixed model with country, time since baseline treatment, and treatment-by-time interaction as fixed effects and participant and participant-by-time interaction as random coefficients at a 1-sided significance level of 0.025.||1.180|-0.223|0.090
71117605|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
70931852|NCT02307682|141364343|OTHER||Difference in proportions|3.0|||||TWO_SIDED|95.0|-3.1|9.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||9.7|-3.1|
71051270|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-41.51|||<|0.001|TWO_SIDED|95.0|-55.51|-27.52|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-27.52|-55.51|<0.001
71051271|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-41.77|||<|0.001|TWO_SIDED|95.0|-55.65|-27.89|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-27.89|-55.65|<0.001
71051272|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-0.16||||0.96|TWO_SIDED|95.0|-6.56|6.23|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||6.23|-6.56|0.960
70851152|NCT00669409|141190511|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-16.6|15.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||15.0|-16.6|
71051273|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-55.73|||<|0.001|TWO_SIDED|95.0|-68.81|-42.65|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-42.65|-68.81|<0.001
71051274|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-6.16||||0.055|TWO_SIDED|95.0|-12.46|0.13|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.13|-12.46|0.055
71051275|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-11.7||||0.001|TWO_SIDED|95.0|-18.7|-4.7|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-4.70|-18.70|0.001
71051276|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-49.41|||<|0.001|TWO_SIDED|95.0|-63.21|-35.6|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-35.60|-63.21|<0.001
71051277|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-44.3|||<|0.001|TWO_SIDED|95.0|-58.04|-30.55|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-30.55|-58.04|<0.001
71051278|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-5.69||||0.151|TWO_SIDED|95.0|-13.46|2.08|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||2.08|-13.46|0.151
71051279|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-56.94|||<|0.001|TWO_SIDED|95.0|-69.96|-43.91|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-43.91|-69.96|<0.001
71051280|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-9.0||||0.01|TWO_SIDED|95.0|-15.8|-2.19|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-2.19|-15.80|0.010
71051281|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-20.11|||<|0.001|TWO_SIDED|95.0|-27.97|-12.24|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-12.24|-27.97|<0.001
71051282|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-47.73|||<|0.001|TWO_SIDED|95.0|-61.64|-33.83|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-33.83|-61.64|<0.001
71051283|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-37.18|||<|0.001|TWO_SIDED|95.0|-50.96|-23.4|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-23.40|-50.96|<0.001
70931853|NCT02307682|141364343|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-6.5|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||6.5|-6.5|
71051284|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-11.19||||0.013|TWO_SIDED|95.0|-20.02|-2.36|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-2.36|-20.02|0.013
70851153|NCT00669409|141190511|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-17.1|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-32.8|-1.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-1.3|-32.8|
70851154|NCT00669409|141190511|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-21.0|10.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.6|-21.0|
70931854|NCT02307682|141364343|OTHER||Difference in proportions|4.9|||||TWO_SIDED|95.0|-1.3|11.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||11.4|-1.3|
70931855|NCT02307682|141364343|OTHER||Difference in proportions|3.7|||||TWO_SIDED|95.0|-2.9|10.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||10.2|-2.9|
71018088|NCT01563029|141543355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.4|||<|0.033|TWO_SIDED|95.0|0.7|16.1|||ANCOVA|||||16.1|0.7|<0.033
71018089|NCT01563029|141543355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.0||||0.042|TWO_SIDED|95.0|0.3|15.7|||ANCOVA|||||15.7|0.3|0.042
71018090|NCT01563029|141543356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.2||||0.037|TWO_SIDED|95.0|0.7|21.7|||ANCOVA|||||21.7|0.7|0.037
71018091|NCT01563029|141543356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.1||||0.014|TWO_SIDED|95.0|2.6|23.6|||ANCOVA|||||23.6|2.6|0.014
71018092|NCT01563029|141543356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9||||0.266|TWO_SIDED|95.0|-4.5|16.3|||ANCOVA|||||16.3|-4.5|0.266
71018093|NCT01563029|141543356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2||||0.242|TWO_SIDED|95.0|-4.2|16.6|||ANCOVA|||||16.6|-4.2|0.242
71018094|NCT01563029|141543357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.6|||<|0.001|TWO_SIDED|95.0|10.0|31.3|||ANCOVA|||||31.3|10.0|<0.001
71018095|NCT01563029|141543357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.9||||0.001|TWO_SIDED|95.0|7.2|28.6|||ANCOVA|||||28.6|7.2|0.001
71018096|NCT01563029|141543357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.5||||0.033|TWO_SIDED|95.0|0.9|22.1|||ANCOVA|||||22.1|0.9|0.033
71018097|NCT01563029|141543357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.7||||0.002|TWO_SIDED|95.0|6.0|27.3|||ANCOVA|||||27.3|6.0|0.002
71018098|NCT01563029|141543358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1||||0.619|TWO_SIDED|95.0|-6.1|10.2|||ANCOVA|||||10.2|-6.1|0.619
71018099|NCT01563029|141543358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8||||0.161||95.0|-2.3|13.9|||ANCOVA|||||13.9|-2.3|0.161
71051285|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-58.14|||<|0.001|TWO_SIDED|95.0|-71.03|-45.26|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-45.26|-71.03|<0.001
71018100|NCT01563029|141543358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9||||0.34|TWO_SIDED|95.0|-4.1|12.0|||ANCOVA|||||12.0|-4.1|0.340
71018101|NCT01563029|141543358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||0.459|TWO_SIDED|95.0|-5.0|11.1|||ANCOVA|||||11.1|-5.0|0.459
71018102|NCT01563029|141543359|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71018103|NCT01563029|141543359|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Fisher Exact|||||||0.006
71018104|NCT01563029|141543359|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||||||0.003
71018105|NCT01563029|141543359|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71018106|NCT00703261|141543435|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||cLDA|||Constrained longitudinal data analysis (cLDA)||||0.006
71018107|NCT00703261|141543435|SUPERIORITY_OR_OTHER|||||||0.277||95.0|||||cLDA|||||||0.277
71018108|NCT00703261|141543435|SUPERIORITY_OR_OTHER||Percent Reduction|4.5||||0.088|TWO_SIDED|90.0|-1.0|9.6|||cLDA|||||9.6|-1.0|0.088
71018109|NCT00703261|141543436|SUPERIORITY_OR_OTHER|||||||0.195||95.0|||||cLDA|||||||0.195
70851155|NCT00669409|141190511|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-12.7|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-28.3|2.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.9|-28.3|
71018110|NCT04466956|141543457|OTHER|Statistical analysis was by intention-to-treat including all randomised participants, using Stata-12 software. Continuous data were summarised as mean and standard deviation, and categorical data as counts and percentages. Between group differences were reported with 95% confidence intervals, and p-values, using t-test to compare normally distributed data and chi-squared tests to compare categorical data.|||||<|0.01|TWO_SIDED|95.0||||Between group differences were reported with 95% confidence intervals, and p-values, using t-test to compare normally distributed data and chi-squared tests to compare categorical data.|t-test, 1 sided|||Mean worst pain scores were 5.98 and 6.88 in the standard care and VR groups respectively, with difference in means -0.9 (95% CI -2.1 - 0.28), p value 0.13. Mean anxiety scores at the end of the procedure were 3.94 and 4.4 in the standard care and VR groups respectively, with difference in means -0.46 (95% CI -2.1, 1.1), p value 0.57.||||<0.01
71018111|NCT00203931|141543458|SUPERIORITY_OR_OTHER|||||||0.11|||||||Log Rank|||||||0.11
71018112|NCT00203931|141543459|SUPERIORITY_OR_OTHER|||||||0.91|||||||Wilcoxon-Gehan test|||||||0.91
71018113|NCT00203931|141543460|SUPERIORITY_OR_OTHER|||||||0.24|||||||Fisher Exact|||||||0.24
71018114|NCT00203931|141543461|SUPERIORITY_OR_OTHER|||||||0.046|||||||Wilcoxon-Gehan test|||||||0.046
71018115|NCT00203931|141543462|SUPERIORITY_OR_OTHER|||||||0.029|||||||Log Rank|||||||0.029
71018116|NCT02426125|141543463|SUPERIORITY||Hazard Ratio (HR)|0.757||||0.0118|TWO_SIDED|95.0|0.607|0.943||Stratified|Log Rank||Stratified|||0.943|0.607|0.0118
71018117|NCT02426125|141543464|SUPERIORITY||Hazard Ratio (HR)|0.887||||0.2461|TWO_SIDED|95.0|0.724|1.086||Stratified|Log Rank||Stratified|||1.086|0.724|0.2461
71018118|NCT02426125|141543467|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.189|TWO_SIDED|95.0|0.473|1.158|||Log Rank|||||1.158|0.473|0.189
71018119|NCT02426125|141543468|SUPERIORITY||Hazard Ratio (HR)|0.879||||0.357|TWO_SIDED|95.0|0.663|1.167||Stratified|Log Rank||Stratified|Global health status/QoL||1.167|0.663|0.357
70851156|NCT00669409|141190511|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-28.9|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-49.6|-8.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-8.2|-49.6|
70851157|NCT00669409|141190512|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-16.8|14.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||14.8|-16.8|
71018120|NCT02587117|141543507|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|95.0|||||Mann Whitney test|||||||0.004
71018121|NCT02587117|141543508|SUPERIORITY_OR_OTHER|||||||0.224|TWO_SIDED|95.0|||||Mann Whitney test|||||||0.224
71051286|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-10.15||||0.005|TWO_SIDED|95.0|-17.24|-3.06|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-3.06|-17.24|0.005
71051287|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-26.77|||<|0.001|TWO_SIDED|95.0|-35.1|-18.44|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-18.44|-35.10|<0.001
71051288|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-47.74|||<|0.001|TWO_SIDED|95.0|-61.76|-33.72|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-33.72|-61.76|<0.001
71051289|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-31.69|||<|0.001|TWO_SIDED|95.0|-45.61|-17.76|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-17.76|-45.61|<0.001
71018122|NCT03701516|141543555|NON_INFERIORITY|Non-inferiority will be established if the lower bound of the credible interval of the mean difference between Test and Control is greater than -5.|Posterior Mean Difference|-0.38|STANDARD_DEVIATION|1.781|||TWO_SIDED|98.0|-4.53|3.85|||Bayesian repeated measurement model|Results were reported as regression coefficient mean estimates with credible intervals (CrI)|Mean difference was calculated as Test - Control|||3.85|-4.53|
70851158|NCT00669409|141190512|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.3|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-35.0|-3.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.5|-35.0|
70851159|NCT00669409|141190512|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-21.8|9.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.8|-21.8|
71051290|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-16.76|||<|0.001|TWO_SIDED|95.0|-26.1|-7.42|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-7.42|-26.10|<0.001
71051291|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-57.58|||<|0.001|TWO_SIDED|95.0|-70.44|-44.72|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-44.72|-70.44|<0.001
70931856|NCT02307682|141364343|OTHER||Difference in proportions|5.8|||||TWO_SIDED|95.0|-0.4|12.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||12.3|-0.4|
70931857|NCT02307682|141364343|OTHER||Difference in proportions|2.4|||||TWO_SIDED|95.0|-4.2|9.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||9.0|-4.2|
71018123|NCT03701516|141543556|NON_INFERIORITY|Non-inferiority will be established if the lower bound of the credible interval of the mean difference between Test and Control is greater than -5.|Posterior Mean Difference|-2.34|STANDARD_DEVIATION|1.263|||TWO_SIDED|98.0|-5.36|0.61|||Bayesian repeated measurement model|Results were reported as regression coefficient mean estimates with credible intervals (CrI)|Mean difference was calculated as Test - Control|||0.61|-5.36|
71018124|NCT03701516|141543557|NON_INFERIORITY|Non-inferiority will be established if the lower bound of the credible interval of the mean difference between Test and Control is greater than -1.|Posterior Mean Difference|-0.06|STANDARD_DEVIATION|0.083|||TWO_SIDED|95.0|-0.22|0.1|||Bayesian repeated measurement model|Results were reported as regression coefficient mean estimates with credible intervals (CrI)|Mean difference was calculated as Test - Control|||0.10|-0.22|
71018125|NCT03701516|141543558|NON_INFERIORITY|Non-inferiority will be established if the upper bound of the credible interval of the mean difference between Test and Control is less than 0.05.|Posterior Mean Difference|0.001|STANDARD_DEVIATION|0.0028|||TWO_SIDED|95.0|-0.005|0.006|||Bayesian repeated measurement random-eff|Results were reported as regression coefficient mean estimates with credible intervals (CrI)|Mean difference was calculated as Test - Control|||0.006|-0.005|
71018126|NCT03701516|141543559|NON_INFERIORITY|Non-inferiority will be established if the upper bound of the credible interval of the mean difference between Test and Control is less than 0.05.|Posterior Mean Difference|-0.003|STANDARD_DEVIATION|0.0029|||TWO_SIDED|95.0|-0.009|0.002|||Bayesian repeated measurement model|Results were reported as regression coefficient mean estimates with credible intervals (CrI)|Mean difference was calculated as Test - Control|||0.002|-0.009|
71018127|NCT00981019|141543562|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||"Study was exploratory, thus no hypotheses had been formalized beforehand.~To analyze repeated measures outcomes (e.g., effect of the four different statistic scenarios on doctors' recommendation of screening, their judgment of screening's effectiveness, etc.), we used the McNemar chi-square test and the Wilcoxon signed-rank test.~To test for order effects (scenarios were randomly presented)Pearson's chi-square test and the Mann-Whitney U test were used."||||<0.05
71051292|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-11.28||||0.004|TWO_SIDED|95.0|-18.99|-3.57|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-3.57|-18.99|0.004
71051293|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-28.06|||<|0.001|TWO_SIDED|95.0|-36.77|-19.35|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-19.35|-36.77|<0.001
71051294|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-46.01|||<|0.001|TWO_SIDED|95.0|-59.98|-32.04|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-32.04|-59.98|<0.001
71051295|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-29.7|||<|0.001|TWO_SIDED|95.0|-43.65|-15.75|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-15.75|-43.65|<0.001
71051296|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-16.94|||<|0.001|TWO_SIDED|95.0|-26.59|-7.29|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-7.29|-26.59|<0.001
71051297|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-52.9|||<|0.001|TWO_SIDED|95.0|-66.06|-39.75|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-39.75|-66.06|<0.001
71051298|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-8.93||||0.042|TWO_SIDED|95.0|-17.53|-0.34|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-0.34|-17.53|0.042
71051299|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-27.25|||<|0.001|TWO_SIDED|95.0|-36.65|-17.86|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-17.86|-36.65|<0.001
71105417|NCT00261833|141718278|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|1.04||||0.058|TWO_SIDED|95.0|-0.26|2.34||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (ie, the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.|95% confidence interval||A mixed model ANCOVA was used to estimate the 95% CI for the difference (Zemaira® - placebo) in the change in lung density.|Analysis of the change in lung density (TLC+FRC combined) from baseline to Month 24 was a mixed effects analysis of covariance (ANCOVA) model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect at a 1-sided significance level of 0.025.||2.34|-0.26|0.058
71018128|NCT03428217|141543591|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.6528|TWO_SIDED|95.0|0.74|1.21|||Log Rank|||Stratified Analysis 1: Stratified by prior programmed cell death protein 1/programmed cell death protein ligand 1 (PD-1/PDL1) inhibitor therapy (yes vs no) and International Metastatic Renal Cell Carcinoma Database (IMDC) prognostic risk group (favorable vs intermediate vs poor).||1.21|0.74|0.6528
71018129|NCT03428217|141543591|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8193|TWO_SIDED|95.0|0.76|1.24|||Log Rank|||Stratified Analysis 2: Stratified by prior PD-1/PD-L1 inhibitor therapy \[yes vs. no\] and IMDC prognostic risk group \[favorable vs. intermediate/poor\].||1.24|0.76|0.8193
71018130|NCT03428217|141543591|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8345|TWO_SIDED|95.0|0.76|1.25|||Log Rank|||Stratified Analysis 3: Stratified by the number of prior anti-angio cancer therapy \[0 vs. \>=1\].||1.25|0.76|0.8345
71018131|NCT03428217|141543591|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9479|TWO_SIDED|95.0|0.78|1.27|||Log Rank|||Unstratified Analysis||1.27|0.78|0.9479
71018132|NCT03428217|141543592|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.3867|TWO_SIDED|95.0|0.83|1.6|||Log Rank|||Stratified Analysis 1: Stratified by prior PD-1/PD-L1 inhibitor therapy \[yes vs. no\] and IMDC prognostic risk group \[favorable vs. intermediate vs. poor\].||1.6|0.83|0.3867
71018133|NCT03428217|141543592|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.3367|TWO_SIDED|95.0|0.85|1.62|||Log Rank|||Stratified Analysis 2: Stratified by prior PD-1/PD-L1 inhibitor therapy \[yes vs. no\] and IMDC prognostic risk group \[favorable vs. intermediate/poor\].||1.62|0.85|0.3367
71018134|NCT03428217|141543592|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.2416|TWO_SIDED|95.0|0.88|1.69|||Log Rank|||Stratified Analysis 3: Stratified by prior PD-1/PD-L1 inhibitor therapy \[yes vs. no\] and IMDC prognostic risk group \[favorable vs. intermediate/poor\].||1.69|0.88|0.2416
71018135|NCT03428217|141543592|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.3043|TWO_SIDED|95.0|0.86|1.64|||Log Rank|||Unstratified Analysis||1.64|0.86|0.3043
71018136|NCT03428217|141543593|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9692|TWO_SIDED|95.0|0.79|1.25|||Log Rank|||Stratified Analysis 1: Stratified by prior PD-1/PD-L1 inhibitor therapy \[yes vs. no\] and IMDC prognostic risk group \[favorable vs. intermediate vs. poor\].||1.25|0.79|0.9692
71018137|NCT03428217|141543593|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9235|TWO_SIDED|95.0|0.8|1.27|||Log Rank|||Stratified Analysis 2: Stratified by prior PD-1/PD-L1 inhibitor therapy \[yes vs. no\] and IMDC prognostic risk group \[favorable vs. intermediate/poor\].||1.27|0.8|0.9235
71018138|NCT03428217|141543593|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9549|TWO_SIDED|95.0|0.8|1.26|||Log Rank|||Stratified Analysis 3: Stratified by the number of prior anti-angio cancer therapy \[0 vs. \>=1\].||1.26|0.8|0.9549
71018139|NCT03428217|141543593|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.8193|TWO_SIDED|95.0|0.82|1.29|||Log Rank|||Unstratified Analysis||1.29|0.82|0.8193
71018140|NCT02304302|141543611|SUPERIORITY||Mean Difference (Net)|0.34||||0.61|TWO_SIDED|95.0|-0.98|1.67|||Mixed Models Analysis|||||1.67|-0.98|0.61
71018141|NCT02304302|141543612|SUPERIORITY||Mean Difference (Net)|-0.32||||0.57|TWO_SIDED|95.0|-1.43|0.8|||Mixed Models Analysis|||||0.80|-1.43|0.57
71051300|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-43.78|||<|0.001|TWO_SIDED|95.0|-57.83|-29.72|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-29.72|-57.83|<0.001
71018142|NCT02304302|141543613|SUPERIORITY||Median Difference (Net)|-0.04||||0.91|TWO_SIDED|95.0|-0.74|0.66|||Mixed Models Analysis|||||0.66|-0.74|0.91
71018143|NCT02304302|141543614|SUPERIORITY||Median Difference (Final Values)|-0.5||||0.48|TWO_SIDED|95.0|-1.91|0.91|||Mixed Models Analysis|||||0.91|-1.91|0.48
71018144|NCT02304302|141543615|SUPERIORITY||Mean Difference (Net)|-1.31||||0.5|TWO_SIDED|95.0|-5.14|2.53|||Mixed Models Analysis|||||2.53|-5.14|0.50
71018145|NCT02304302|141543616|SUPERIORITY||Mean Difference (Net)|-0.1||||0.62|TWO_SIDED|95.0|-0.52|0.32|||Mixed Models Analysis|||||0.32|-0.52|0.62
71018146|NCT02304302|141543617|SUPERIORITY||Mean Difference (Net)|2.94||||0.84|TWO_SIDED|95.0|-25.32|31.2|||Mixed Models Analysis|||||31.20|-25.32|0.84
71018147|NCT02304302|141543618|SUPERIORITY||Mean Difference (Net)|-3.04||||0.24|TWO_SIDED|95.0|||||ANOVA|||QTc interval duration was the independent variable, treatment and time were the categorical factors.||||0.24
71018148|NCT02304302|141543619|SUPERIORITY||Mean Difference (Net)|1.91||||0.28|TWO_SIDED|95.0|-1.57|5.39|||Mixed Models Analysis|||||5.39|-1.57|0.28
71018149|NCT02304302|141543620|SUPERIORITY||Mean Difference (Net)|0.4||||0.51|TWO_SIDED|95.0|-0.8|1.61|||Mixed Models Analysis|||||1.61|-0.80|0.51
71018150|NCT02304302|141543621|SUPERIORITY||Mean Difference (Net)|1.17||||0.63|TWO_SIDED|95.0|-3.6|5.94|||Mixed Models Analysis|||||5.94|-3.6|0.63
71018151|NCT02304302|141543622|SUPERIORITY||Mean Difference (Net)|-3.65||||0.17|TWO_SIDED|95.0|-8.91|1.61|||Mixed Models Analysis|||||1.61|-8.91|0.17
71018152|NCT01345058|141543645|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.49|TWO_SIDED|95.0|0.35|1.65|||Chi-squared||Hazard ratio for seizure occurrence for polytherapy relative to monotherapy.|||1.65|0.35|0.49
71018153|NCT01892020|141543655|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.12|STANDARD_ERROR_OF_MEAN|0.27|<|0.001||95.0|-1.66|-0.58||The 2-h PPG increment was analyzed using a normal linear mixed model with period and treatment as fixed effects and subject as a random effect.|Mixed Models Analysis|||Let D be the treatment difference (BIAsp 50 BID + metformin minus BHI 50 BID + metformin) of 2-h PPG increment after a 4-week treatment. The null hypothesis was D = 0 mmol/L. The alternative hypothesis was D ≠ 0 mmol/L. Sample size was determined using a two-sided one sample t-test at a = 0.05 under the assumption of 0.8 mmol/L mean treatment different and 80% power.||-0.58|-1.66|< 0.001
71018154|NCT02149199|141543764|SUPERIORITY||Odds Ratio (OR)|1.14||||0.046|TWO_SIDED|95.0|1.0|1.3|||Regression, Logistic|Repeated measures logistic regression, with treatment, pre-study treatment, region and study week as fixed effects.|An odds ratio greater than 1 favours Symbicort 'as needed'|||1.30|1.00|0.046
71018155|NCT02149199|141543764|NON_INFERIORITY|Non-inferiority analysis based on CI instead of p-value, hence no p-value calculated for this analysis. Lower limit of the 2-sided 95% CI \>=0.8 indicates Symbicort 'as needed' is non-inferior to Pulmicort bid.|Odds Ratio (OR)|0.64|||||TWO_SIDED|95.0|0.57|0.73|||Regression, Logistic|Repeated measures logistic regression with treatment, pre-study treatment, region and study week as fixed effects.||||0.73|0.57|
70931858|NCT02307682|141364343|OTHER||Difference in proportions|5.6|||||TWO_SIDED|95.0|-0.2|11.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||11.9|-0.2|
70931859|NCT02307682|141364343|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-3.0|9.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||9.9|-3.0|
70931860|NCT02307682|141364343|OTHER||Difference in proportions|5.1|||||TWO_SIDED|95.0|-1.1|11.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||11.4|-1.1|
71018156|NCT02149199|141543765|SUPERIORITY||Hazard Ratio (HR)|0.435|||<|0.001|TWO_SIDED|95.0|0.328|0.577|||Regression, Cox|Cox-regression model with randomised treatment, pre-study treatment, severe exacerbations in the last 12 months (0, \>=1) and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first severe exacerbation.|||0.577|0.328|<0.001
71018157|NCT02149199|141543765|SUPERIORITY||Hazard Ratio (HR)|0.901||||0.524|TWO_SIDED|95.0|0.653|1.242|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first severe exacerbation.|||1.242|0.653|0.524
71018158|NCT02149199|141543766|SUPERIORITY||Hazard Ratio (HR)|0.429|||<|0.001|TWO_SIDED|95.0|0.348|0.528|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first moderate or severe exacerbation.|||0.528|0.348|<0.001
71018159|NCT02149199|141543766|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.436|TWO_SIDED|95.0|0.718|1.153|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first moderate or severe exacerbation.|||1.153|0.718|0.436
71018160|NCT02149199|141543767|SUPERIORITY||Mean Difference (Net)|53.8|||<|0.001|TWO_SIDED|95.0|29.1|78.5|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and (treatment x visit) as fixed, patient as random and baseline FEV1 as continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'. This is the estimate across all treatment visits.|||78.5|29.1|<0.001
71018161|NCT02149199|141543767|SUPERIORITY||Mean Difference (Net)|-54.3|||<|0.001|TWO_SIDED|95.0|-78.8|-29.8|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and (treatment x visit) as fixed, patient as random and baseline FEV1 as continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'. This is the estimate across all treatment visits.|||-29.8|-78.8|<0.001
71018162|NCT02149199|141543768|SUPERIORITY||Mean Difference (Net)|11.95|||<|0.001|TWO_SIDED|95.0|7.89|16.0|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline PEF as a continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'.|||16.00|7.89|<0.001
71018163|NCT02149199|141543768|SUPERIORITY||Mean Difference (Net)|-9.98|||<|0.001|TWO_SIDED|95.0|-14.03|-5.93|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline PEF as a continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'.|||-5.93|-14.03|<0.001
71051301|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-25.75|||<|0.001|TWO_SIDED|95.0|-39.93|-11.57|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-11.57|-39.93|<0.001
71018164|NCT02149199|141543769|SUPERIORITY||Mean Difference (Net)|10.94|||<|0.001|TWO_SIDED|95.0|6.99|14.9|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline PEF as a continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'.|||14.90|6.99|<0.001
71018165|NCT02149199|141543769|SUPERIORITY||Mean Difference (Net)|-6.23||||0.002|TWO_SIDED|95.0|-10.18|-2.29|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline PEF as a continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'.|||-2.29|-10.18|0.002
71018166|NCT02149199|141543771|SUPERIORITY||Mean Difference (Net)|-0.12|||<|0.001|TWO_SIDED|95.0|-0.18|-0.06|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline asthma symptom score as a continuous covariate.|Mean difference less than 0 favours Symbicort 'as needed'.|||-0.06|-0.18|<0.001
71018167|NCT02149199|141543771|SUPERIORITY||Mean Difference (Net)|0.09||||0.004|TWO_SIDED|95.0|0.03|0.15|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline asthma symptom score as a continuous covariate.|Mean difference less than 0 favours Symbicort 'as needed'.|||0.15|0.03|0.004
71051302|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-18.49|||<|0.001|TWO_SIDED|95.0|-28.39|-8.59|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-8.59|-28.39|<0.001
71105418|NCT00261833|141718278|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|1.32||||0.028|TWO_SIDED|95.0|-0.03|2.67||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (i.e., the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.|95% confidence interval||A mixed model ANCOVA was used to estimate the 95% CI for the difference (Zemaira® - placebo) in the change in lung density.|Analysis of the change in lung density (TLC) from baseline to Month 24 was a mixed effects ANCOVA model with country, treatment, and baseline lung density as fixed effects at a 1-sided significance level of 0.025.||2.67|-0.03|0.028
71105419|NCT00261833|141718278|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|0.89||||0.115|TWO_SIDED|95.0|-0.57|2.34||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (ie, the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.|95% confidence interval||A mixed model ANCOVA was used to estimate the 95% CI for the difference (Zemaira® - placebo) in the change in lung density.|Analysis of the change in lung density (FRC) from baseline to Month 24 was a mixed effects ANCOVA model with country, treatment, and baseline lung density as fixed effects as a repeated random effect at a 1-sided significance level of 0.025.||2.34|-0.57|0.115
70941622|NCT04748445|141383934|OTHER||Slope|-1.407|STANDARD_ERROR_OF_MEAN|1.194||0.2411|TWO_SIDED|90.0|-3.385|5.724|||Mixed Models Analysis|||EE\_MFCC mean 04 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit, estimated value and dispersion value it was 10\^-1. For upper limit it was 10\^-2).||5.724|-3.385|0.2411
71018168|NCT02149199|141543778|SUPERIORITY||Hazard Ratio (HR)|0.413|||<|0.001|TWO_SIDED|95.0|0.343|0.497|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first additional steroids.|||0.497|0.343|<0.001
71018169|NCT02149199|141543778|SUPERIORITY||Hazard Ratio (HR)|0.865||||0.175|TWO_SIDED|95.0|0.701|1.067|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first additional steroids.|||1.067|0.701|0.175
71018170|NCT02149199|141543779|SUPERIORITY||Mean Difference (Net)|-0.154|||<|0.001|TWO_SIDED|95.0|-0.203|-0.105|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and (treatment x visit) as fixed, patient as random and baseline ACQ-5 as continuous covariate|Mean difference less than 0 favours Symbicort 'as needed'.|||-0.105|-0.203|<0.001
71018171|NCT02149199|141543779|SUPERIORITY||Mean Difference (Net)|0.149|||<|0.001|TWO_SIDED|95.0|0.101|0.198|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and (treatment x visit) as fixed, patient as random and baseline ACQ-5 as continuous covariate|Mean difference less than 0 favours Symbicort 'as needed'.|||0.198|0.101|<0.001
71018172|NCT02149199|141543780|SUPERIORITY||Mean Difference (Net)|0.127|||<|0.001|TWO_SIDED|95.0|0.074|0.181|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and treatment x visit as fixed, patient as random and baseline AQLQ(S) as continuous covariate|Mean difference greater than 0 favours Symbicort 'as needed'.|||0.181|0.074|<0.001
71018173|NCT02149199|141543780|SUPERIORITY||Mean Difference (Net)|-0.102|||<|0.001|TWO_SIDED|95.0|-0.155|-0.049|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and treatment x visit as fixed, patient as random and baseline AQLQ(S) as continuous covariate|Mean difference greater than 0 favours Symbicort 'as needed'.|||-0.049|-0.155|<0.001
71018174|NCT02149199|141543782|SUPERIORITY||Rate ratio|0.36|||<|0.001|TWO_SIDED|95.0|0.27|0.49|||Negative binomial model|Negative binomial model with treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates|A rate ratio less than 1 indicates a lower rate of severe exacerbations in the Symbicort 'as needed' treatment group.|||0.49|0.27|<0.001
71105420|NCT00402987|141718296|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.7||||0.0003||95.0|5.5|17.9|||generalized linear model|p-value was calculated using Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||Null hypothesis: No difference in SPID2 (PI-VAS) at two hours between celecoxib 100 mg and placebo. Sample size was based on an expected effect size of 0.42 (from earlier studies), 80% power and an alpha of 0.05.||17.9|5.5|0.0003
71105421|NCT00402987|141718297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.212||95.0||||"Analysis at 15 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.212
71105422|NCT00402987|141718297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.056||95.0||||"Analysis at 30 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.056
71018175|NCT02149199|141543782|SUPERIORITY||Rate ratio|0.83||||0.279|TWO_SIDED|95.0|0.59|1.16|||Negative binomial model|Negative binomial model with treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates|A rate ratio less than 1 indicates a lower rate of severe exacerbations in the Symbicort 'as needed' treatment group.|||1.16|0.59|0.279
71018176|NCT02149199|141543783|SUPERIORITY||Rate ratio|0.4|||<|0.001|TWO_SIDED|95.0|0.32|0.49|||Negative binomial model|Negative binomial model with treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates|A rate ratio less than 1 indicates a lower rate of moderate or severe exacerbations in the Symbicort 'as needed' treatment group.|||0.49|0.32|<0.001
70851160|NCT00669409|141190512|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-12.4|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-28.0|3.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.2|-28.0|
71018177|NCT02149199|141543783|SUPERIORITY||Rate ratio|0.95||||0.663|TWO_SIDED|95.0|0.74|1.21|||Negative binomial model|Negative binomial model with treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates|A rate ratio less than 1 indicates a lower rate of moderate or severe exacerbations in the Symbicort 'as needed' treatment group.|||1.21|0.74|0.663
71018178|NCT01500434|141543837|NON_INFERIORITY_OR_EQUIVALENCE|Study had 85% statistical power to demonstrate that the 12-month rate for TLF (accounting for an expected 1-year attrition rate of 5%) is less than the performance goal, assuming a 1-year TLF rate of 9.0%.|Target Lesion Failure Rate|3.2|||<|0.0001|ONE_SIDED|95.0||7.96|||One-group exact binomial test|||A one-group exact binomial test was used to test the hypothesis that the primary endpoint rate in the PROMUS Element cohort is less than the predefined performance goal of 19.4%.||7.96||<0.0001
71051303|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-45.27|||<|0.001|TWO_SIDED|95.0|-58.96|-31.58|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-31.58|-58.96|<0.001
71051304|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-8.88||||0.064|TWO_SIDED|95.0|-18.27|0.5|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.50|-18.27|0.064
71051305|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-26.98|||<|0.001|TWO_SIDED|95.0|-36.91|-17.05|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-17.05|-36.91|<0.001
71051306|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-36.26|||<|0.001|TWO_SIDED|95.0|-50.45|-22.07|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-22.07|-50.45|<0.001
71051307|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-18.58||||0.01|TWO_SIDED|95.0|-32.64|-4.52|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-4.52|-32.64|0.010
71051308|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-18.17|||<|0.001|TWO_SIDED|95.0|-28.44|-7.9|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-7.90|-28.44|<0.001
71051309|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-34.21|||<|0.001|TWO_SIDED|95.0|-48.21|-20.21|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-20.21|-48.21|<0.001
71051310|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-6.97||||0.179|TWO_SIDED|95.0|-17.12|3.19|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||3.19|-17.12|0.179
71051311|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-20.7|||<|0.001|TWO_SIDED|95.0|-31.04|-10.35|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-10.35|-31.04|<0.001
71105423|NCT00402987|141718297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||"Analysis at 45 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.005
71051312|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-27.2|||<|0.001|TWO_SIDED|95.0|-41.44|-12.96|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-12.96|-41.44|<0.001
71051313|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-13.9||||0.051|TWO_SIDED|95.0|-27.84|0.04|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.04|-27.84|0.051
71051314|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-13.76||||0.01|TWO_SIDED|95.0|-24.21|-3.31|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-3.31|-24.21|0.010
71051315|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-23.25||||0.001|TWO_SIDED|95.0|-37.31|-9.2|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-9.20|-37.31|0.001
71051316|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-2.22||||0.676|TWO_SIDED|95.0|-12.63|8.19|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||8.19|-12.63|0.676
71051317|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-13.15||||0.013|TWO_SIDED|95.0|-23.57|-2.74|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-2.74|-23.57|0.013
71051318|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-20.94||||0.004|TWO_SIDED|95.0|-35.18|-6.69|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-6.69|-35.18|0.004
71051319|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-10.39||||0.14|TWO_SIDED|95.0|-24.19|3.4|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||3.40|-24.19|0.140
71051320|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-11.06||||0.038|TWO_SIDED|95.0|-21.51|-0.61|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-0.61|-21.51|0.038
71105424|NCT00402987|141718297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 60 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.002
71051321|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-17.9||||0.013||95.0|-32.13|-3.79|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||-3.79|-32.13|0.013
71051322|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-3.85||||0.467||95.0|-14.23|6.53|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||6.53|-14.23|0.467
71051323|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-10.38||||0.049||95.0|-20.73|-0.02|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-0.02|-20.73|0.049
71051324|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-14.1||||0.05||95.0|-28.22|0.02|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.02|-28.22|0.050
71051325|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-7.99||||0.255||95.0|-21.73|5.76|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||5.76|-21.73|0.255
71051326|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-6.57||||0.212||95.0|-16.89|3.75|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||3.75|-16.89|0.212
71051327|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-15.68||||0.027||95.0|-29.59|-1.77|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||-1.77|-29.59|0.027
71051328|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-4.39||||0.399|TWO_SIDED|95.0|-14.59|5.82|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||5.82|-14.59|0.399
71051329|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-7.5||||0.152||95.0|-17.76|2.77|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||2.77|-17.76|0.152
71051330|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-11.32||||0.106|TWO_SIDED|95.0|-25.05|2.4|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||2.40|-25.05|0.106
71051331|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-8.59||||0.21||95.0|-22.0|4.83|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||4.83|-22.00|0.210
71051332|NCT02912650|141608113|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-3.13||||0.545||95.0|-13.26|7.0|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||7.00|-13.26|0.545
71105425|NCT00402987|141718297|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 75 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
70851161|NCT00669409|141190512|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-29.9|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-50.6|-9.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-9.1|-50.6|
71051333|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|20.74|||<|0.001|TWO_SIDED|95.0|10.54|30.94|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||30.94|10.54|<0.001
71051334|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|4.52||||0.342|TWO_SIDED|95.0|-4.81|13.86|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||13.86|-4.81|0.342
71051335|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|3.62||||0.459|TWO_SIDED|95.0|-5.98|13.22|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||13.22|-5.98|0.459
71051336|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|16.2||||0.001|TWO_SIDED|95.0|6.24|26.17|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||26.17|6.24|0.001
71051337|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|17.37|||<|0.001|TWO_SIDED|95.0|7.42|27.31|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||27.31|7.42|<0.001
71105426|NCT00402987|141718297|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 90 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71051338|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-0.91||||0.849|TWO_SIDED|95.0|-10.2|8.42|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||8.42|-10.2|0.849
71051339|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.08|||<|0.001|TWO_SIDED|95.0|39.53|62.62|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||62.62|39.53|<0.001
71051340|NCT02912650|141608114|SUPERIORITY_OR_OTHER||Cumulative Percentage of Participants wi|5.16||||0.318|TWO_SIDED|95.0|-4.97|15.3|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.30|-4.97|0.318
71051341|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.86||||0.062|TWO_SIDED|95.0|-0.49|20.21|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||20.21|-0.49|0.062
71051342|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|45.6|||<|0.001|TWO_SIDED|95.0|33.45|57.76|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||57.76|33.45|<0.001
71105427|NCT00402987|141718297|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71051343|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|41.07|||<|0.001|TWO_SIDED|95.0|28.76|53.38|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||53.38|28.76|<0.001
70851162|NCT00669409|141190513|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-11.9|19.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||19.7|-11.9|
70851163|NCT00669409|141190513|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.3|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-35.1|-3.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.6|-35.1|
71051344|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|4.74||||0.374|TWO_SIDED|95.0|-5.7|15.17|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.17|-5.70|0.374
71105428|NCT00402987|141718297|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105429|NCT00402987|141718297|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
70851164|NCT00669409|141190513|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-21.3|10.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.3|-21.3|
71051345|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|60.09|||<|0.001|TWO_SIDED|95.0|47.93|72.26|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||72.26|47.93|<0.001
71051346|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|4.3||||0.323|TWO_SIDED|95.0|-4.22|12.81|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||12.81|-4.22|0.323
71051347|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.86||||0.032|TWO_SIDED|95.0|0.86|18.86|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.86|0.86|0.032
71051348|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|55.66|||<|0.001|TWO_SIDED|95.0|43.11|68.2|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||68.20|43.11|<0.001
71051349|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.38|||<|0.001|TWO_SIDED|95.0|37.71|63.05|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||63.05|37.71|<0.001
71105430|NCT00402987|141718297|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105431|NCT00402987|141718297|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105432|NCT00402987|141718297|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105433|NCT00402987|141718298|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 7 hours~Overall P-value"|Generalized Linear Model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
71051350|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|5.61||||0.232|TWO_SIDED|95.0|-3.58|14.8|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.80|-3.58|0.232
71051351|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|59.92|||<|0.001|TWO_SIDED|95.0|47.39|72.46|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||72.46|47.39|<0.001
71051352|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|5.51||||0.179|TWO_SIDED|95.0|-2.52|13.53|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||13.53|-2.52|0.179
71051353|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.37||||0.003|TWO_SIDED|95.0|4.65|22.1|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||22.10|4.65|0.003
71051354|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|54.32|||<|0.001|TWO_SIDED|95.0|41.36|67.29|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||67.29|41.36|<0.001
71051355|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|46.74|||<|0.001|TWO_SIDED|95.0|33.5|59.99|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||59.99|33.50|<0.001
71051356|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
71051357|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|60.51|||<|0.001|TWO_SIDED|95.0|47.99|73.03|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||73.03|47.99|<0.001
71051358|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.08||||0.135|TWO_SIDED|95.0|-1.89|14.05|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.05|-1.89|0.135
71051359|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.97||||0.002|TWO_SIDED|95.0|5.3|22.64|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||22.64|5.30|0.002
71051360|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|54.32|||<|0.001|TWO_SIDED|95.0|41.36|67.29|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||67.29|41.36|<0.001
71051361|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|46.74|||<|0.001|TWO_SIDED|95.0|33.5|59.99|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||59.99|33.50|<0.001
71051362|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
71051363|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
71051364|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
71051365|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
71051366|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
71051367|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
71051368|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
70931861|NCT02307682|141364343|OTHER||Difference in proportions|6.0|||||TWO_SIDED|95.0|-1.5|12.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||12.8|-1.5|
70931862|NCT02307682|141364343|OTHER||Difference in proportions|5.0|||||TWO_SIDED|95.0|-1.0|11.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||11.6|-1.0|
70931863|NCT02307682|141364343|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-5.1|8.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||8.6|-5.1|
70931864|NCT02307682|141364343|OTHER||Difference in proportions|8.8|||||TWO_SIDED|95.0|2.7|15.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||15.4|2.7|
71051369|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
71051370|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
71051371|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
71051372|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
71051373|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
71051374|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
71051375|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
71051376|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
71051377|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
70931865|NCT02307682|141364343|OTHER||Difference in proportions|3.3|||||TWO_SIDED|95.0|-3.7|9.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||9.4|-3.7|
71051378|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
71051379|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
71051380|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
71051381|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
71051382|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
71051383|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
71051384|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
71051385|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
71051386|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
71051387|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
71051388|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
71051389|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
71051390|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
71051391|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
71051392|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
71051393|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
71051394|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
71051395|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
71051396|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001||95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
71051397|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001||95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|< 0.001
71051398|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087||95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
71051399|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001||95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||71.00|45.24|< 0.001
70931866|NCT02307682|141364343|OTHER||Difference in proportions|4.2|||||TWO_SIDED|95.0|-2.2|10.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||10.3|-2.2|
70931867|NCT02307682|141364343|OTHER||Difference in proportions|4.1|||||TWO_SIDED|95.0|-3.0|10.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||10.9|-3.0|
70931868|NCT02307682|141364343|OTHER||Difference in proportions|8.0|||||TWO_SIDED|95.0|1.9|14.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||14.6|1.9|
70931869|NCT02307682|141364343|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-5.1|8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||8.3|-5.1|
71051400|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071||95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
71051401|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001||95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|< 0.001
71105434|NCT00402987|141718298|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105435|NCT00402987|141718298|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0||||"Analysis at 9 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.006
70931870|NCT02307682|141364343|OTHER||Difference in proportions|5.9|||||TWO_SIDED|95.0|0.0|12.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||12.5|-0.0|
71051402|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||64.09|37.39|<0.001
71051403|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
71051404|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087||95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||16.97|-1.15|0.087
71051405|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
71105436|NCT00402987|141718298|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0||||"Analysis at 10 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.007
70931871|NCT02307682|141364343|OTHER||Difference in proportions|5.5|||||TWO_SIDED|95.0|-1.2|12.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||12.3|-1.2|
71051406|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071||95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
71105437|NCT00402987|141718298|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||95.0||||"Analysis at 11 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.014
71105438|NCT00402987|141718298|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0||||"Analysis at 12 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.012
71105439|NCT00402987|141718298|SUPERIORITY_OR_OTHER_LEGACY|||||||0.365||95.0||||"Analysis at 24 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.365
71105440|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized Linear Model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.180
70931872|NCT02307682|141364343|OTHER||Difference in proportions|7.2|||||TWO_SIDED|95.0|1.4|13.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||13.8|1.4|
70931873|NCT02307682|141364344|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-4.3|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||6.9|-4.3|
70931874|NCT02307682|141364344|OTHER||Difference in proportions|6.3|||||TWO_SIDED|95.0|0.6|12.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||12.2|0.6|
70931875|NCT02307682|141364344|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-6.6|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||6.7|-6.6|
70931876|NCT02307682|141364344|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-4.7|8.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||8.0|-4.7|
70931877|NCT02307682|141364344|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-6.2|7.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||7.1|-6.2|
70931878|NCT02307682|141364344|OTHER||Difference in proportions|6.0|||||TWO_SIDED|95.0|-0.8|12.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||12.7|-0.8|
71018179|NCT02395536|141543908|NON_INFERIORITY|A non-inferiority margin of 5% was chosen since the inability to rule out a 5% increase in untoward event rate associated with moving the Reveal LINQ procedure in-office may suggest that in-office procedures would too high of a complication rate compared procedures performed in the traditional office setting.|Risk Difference (RD)|-0.001|||<|0.001|TWO_SIDED|95.0|-0.03|0.029||P-value for non-inferiority versus a 5% non-inferiority margin.|Farrington-Manning test||The estimated value and its associated confidence interval are for the in-office minus traditional hospital setting difference in the untoward event rates. The point estimate is negative since the in-office rate was lower than the hospital rate.|The null hypothesis was that Reveal LINQ insertions performed in-office would have a higher untoward event rate than insertions performed in the traditional hospital setting. A sample size of 476 subjects was estimated to provide at least 90% power at a 1-sided alpha level of 2.5% and 5% non-inferiority margin. For the sample size calculation, an event rate of 2.0% was assumed in both arms. The Farrington-Manning test of two indepent proportions was used to compare study arms.||0.029|-0.030|<0.001
71018180|NCT01186744|141543916|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Log Rank|||||||0.0008
70931879|NCT02307682|141364344|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-6.0|7.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||7.7|-6.0|
71018181|NCT01186744|141543916|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
71018182|NCT01186744|141543917|SUPERIORITY_OR_OTHER|||||||0.0027|TWO_SIDED||||||Log Rank|||||||0.0027
71051407|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
70931880|NCT02307682|141364344|OTHER||Difference in proportions|5.6|||||TWO_SIDED|95.0|-1.5|12.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||12.2|-1.5|
71018183|NCT01186744|141543917|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
71018184|NCT02547779|141544041|SUPERIORITY||Odds Ratio (OR)|0.95|||<|0.05|TWO_SIDED||||||Regression, Logistic|||||||<0.05
71018185|NCT02547779|141544042|SUPERIORITY||Odds Ratio (OR)|0.98|||<|0.05|TWO_SIDED||||||Regression, Logistic|||||||<0.05
71018186|NCT01020773|141544043|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
71051408|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
71051409|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001||95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
71051410|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
71051411|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
71051412|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071||95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
71051413|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001||95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
71051414|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001||95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
71051415|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
71051416|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
71051417|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
71051418|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
71105441|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.069||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.069
71105442|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.010
71051419|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
71051420|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
71051421|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
71051422|NCT02912650|141608114|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
71051423|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|1.16||||0.156|TWO_SIDED|95.0|-0.44|2.75|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||2.75|-0.44|0.156
71051424|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|1.16||||0.155|TWO_SIDED|95.0|-0.44|2.76|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||2.76|-0.44|0.155
71105443|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.002
71105444|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
70851165|NCT00669409|141190513|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-12.2|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-27.8|3.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.4|-27.8|
71051425|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-0.68||||0.605|TWO_SIDED|95.0|-3.27|1.9|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||1.90|-3.27|0.605
71051426|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|1.84||||0.079|TWO_SIDED|95.0|-0.21|3.89|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||3.89|-0.21|0.079
71051427|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-1.85||||0.078|TWO_SIDED|95.0|-3.9|0.21|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.21|-3.90|0.078
71051428|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|21.47|||<|0.001|TWO_SIDED|95.0|15.33|27.62|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||27.62|15.33|<0.001
71051429|NCT02912650|141608115|SUPERIORITY_OR_OTHER||Cumulative Percentage of Participants wi|7.79||||0.056|TWO_SIDED|95.0|-0.19|15.77|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.77|-0.19|0.056
71051430|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-0.37||||0.934|TWO_SIDED|95.0|-9.18|8.43|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||8.43|-9.18|0.934
71051431|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.67|||<|0.001|TWO_SIDED|95.0|8.58|18.77|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.77|8.58|<0.001
71051432|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|21.96|||<|0.001|TWO_SIDED|95.0|15.64|28.28|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||28.28|15.64|<0.001
70931881|NCT02307682|141364344|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-6.5|7.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||7.0|-6.5|
71051433|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-8.21||||0.05|TWO_SIDED|95.0|-16.4|-0.01|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-0.01|-16.40|0.050
71051434|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|55.89|||<|0.001|TWO_SIDED|95.0|47.05|64.73|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.73|47.05|<0.001
71051435|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|12.99||||0.015|TWO_SIDED|95.0|2.5|23.49|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.49|2.50|0.015
71051436|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.16||||0.188|TWO_SIDED|95.0|-3.51|17.82|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||17.82|-3.51|0.188
71051437|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|42.61|||<|0.001|TWO_SIDED|95.0|33.85|51.38|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||51.38|33.85|<0.001
71051438|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|48.58|||<|0.001|TWO_SIDED|95.0|39.63|57.54|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||57.54|39.63|<0.001
71051439|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-5.98||||0.266|TWO_SIDED|95.0|-16.51|4.55|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||4.55|-16.51|0.266
70941623|NCT04748445|141383934|OTHER||Slope|-0.004466|STANDARD_ERROR_OF_MEAN|8.869||0.9599|TWO_SIDED|90.0|-0.1514|0.1425|||Mixed Models Analysis|||EE\_MFCC mean 05 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1425|-0.1514|0.9599
71051440|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|59.77|||<|0.001|TWO_SIDED|95.0|49.63|69.9|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||69.90|49.63|<0.001
71051441|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|8.62||||0.094|TWO_SIDED|95.0|-1.46|18.69|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.69|-1.46|0.094
71051442|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|10.43||||0.047|TWO_SIDED|95.0|0.15|20.72|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||20.72|0.15|0.047
71051443|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.95|||<|0.001|TWO_SIDED|95.0|40.5|61.4|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||61.40|40.50|<0.001
71051444|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|49.34|||<|0.001|TWO_SIDED|95.0|38.79|59.89|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||59.89|38.79|<0.001
71051445|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|1.79||||0.734|TWO_SIDED|95.0|-8.56|12.14|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||12.14|-8.56|0.734
71051446|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.46|||<|0.001|TWO_SIDED|95.0|46.88|70.03|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||70.03|46.88|<0.001
71051447|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.01||||0.152|TWO_SIDED|95.0|-2.57|16.59|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.59|-2.57|0.152
71051448|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.0||||0.073|TWO_SIDED|95.0|-0.83|19.82|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||19.82|-0.83|0.073
71105445|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71051449|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.3|||<|0.001|TWO_SIDED|95.0|39.38|63.21|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||63.21|39.38|<0.001
71051450|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|49.49|||<|0.001|TWO_SIDED|95.0|37.5|61.47|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||61.47|37.50|<0.001
71051451|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|1.99||||0.694|TWO_SIDED|95.0|-7.91|11.89|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||11.89|-7.91|0.694
71051452|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|60.61|||<|0.001|TWO_SIDED|95.0|48.37|72.84|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||72.84|48.37|<0.001
71051453|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.58||||0.135|TWO_SIDED|95.0|-2.05|15.2|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.20|-2.05|0.135
71051454|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|14.74||||0.002|TWO_SIDED|95.0|5.5|23.97|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.97|5.50|0.002
71051455|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|53.82|||<|0.001|TWO_SIDED|95.0|41.31|66.32|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||66.32|41.31|<0.001
71051456|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|45.93|||<|0.001|TWO_SIDED|95.0|33.21|58.66|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||58.66|33.21|<0.001
71051457|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|8.18||||0.091|TWO_SIDED|95.0|-1.32|17.69|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||17.69|-1.32|0.091
71051458|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|60.0|||<|0.001|TWO_SIDED|95.0|47.59|72.42|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||72.42|47.59|<0.001
71051459|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.03||||0.159|TWO_SIDED|95.0|-2.36|14.43|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.43|-2.36|0.159
71051460|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.32|||<|0.001|TWO_SIDED|95.0|6.23|24.41|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||24.41|6.23|<0.001
71051461|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|53.79|||<|0.001|TWO_SIDED|95.0|41.08|66.5|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||66.50|41.08|<0.001
71051462|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|44.76|||<|0.001|TWO_SIDED|95.0|31.72|57.81|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||57.81|31.72|<0.001
71051463|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.28||||0.052|TWO_SIDED|95.0|-0.08|18.64|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.64|-0.08|0.052
71051464|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|57.57|||<|0.001|TWO_SIDED|95.0|44.75|70.39|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||70.39|44.75|<0.001
71051465|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.06||||0.147|TWO_SIDED|95.0|-2.13|14.25|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.25|-2.13|0.147
71051466|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.3|||<|0.001|TWO_SIDED|95.0|6.39|24.21|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||24.21|6.39|<0.001
71105446|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105447|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71051467|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.32|||<|0.001|TWO_SIDED|95.0|38.16|64.48|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.48|38.16|<0.001
71051468|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|42.28|||<|0.001|TWO_SIDED|95.0|28.74|55.82|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||55.82|28.74|<0.001
71051469|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.27||||0.049|TWO_SIDED|95.0|0.04|18.49|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.49|0.04|0.049
70851166|NCT00669409|141190513|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-25.0|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-45.8|-4.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-4.3|-45.8|
71051470|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.71|||<|0.001|TWO_SIDED|95.0|45.93|71.49|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.49|45.93|<0.001
71051471|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.64||||0.105|TWO_SIDED|95.0|-1.38|14.67|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.67|-1.38|0.105
71051472|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.86|||<|0.001|TWO_SIDED|95.0|7.08|24.63|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||24.63|7.08|<0.001
71105448|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105449|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105450|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105451|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71018187|NCT02675426|141544044|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|28.1|||<|0.001|TWO_SIDED|95.0|19.1|37.0||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||37.0|19.1|<0.001
71018188|NCT02675426|141544044|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|30.5|||<|0.001|TWO_SIDED|95.0|21.6|39.4||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||39.4|21.6|<0.001
71018189|NCT02675426|141544045|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|31.2|||<|0.001|TWO_SIDED|95.0|23.0|39.5||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||39.5|23.0|<0.001
71018190|NCT02675426|141544045|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|30.8|||<|0.001|TWO_SIDED|95.0|22.5|39.0||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||39.0|22.5|<0.001
71018191|NCT02675426|141544046|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Least Squares (LS) Mean Difference|-1.18|||<|0.001|TWO_SIDED|95.0|-1.42|-0.94||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|Analysis of covariance (ANCOVA) model with treatment, prior bDMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.94|-1.42|<0.001
71018192|NCT02675426|141544046|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-1.32|||<|0.001|TWO_SIDED|95.0|-1.56|-1.08||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior bDMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-1.08|-1.56|<0.001
71018193|NCT02675426|141544047|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-0.33|||<|0.001|TWO_SIDED|95.0|-0.43|-0.24||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior bDMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.24|-0.43|<0.001
71018194|NCT02675426|141544047|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-0.28|||<|0.001|TWO_SIDED|95.0|-0.38|-0.18||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior bDMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.18|-0.38|<0.001
71018195|NCT02675426|141544048|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|4.55|||<|0.001|TWO_SIDED|95.0|3.13|5.98||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||5.98|3.13|<0.001
71105452|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.096||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.096
71105453|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.034
71105454|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.022
71105455|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.010
71105456|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.005
71105457|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.002
70931882|NCT02307682|141364344|OTHER||Difference in proportions|5.2|||||TWO_SIDED|95.0|-1.8|12.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||12.2|-1.8|
71018196|NCT02675426|141544048|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|4.98|||<|0.001|TWO_SIDED|95.0|3.54|6.42||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||6.42|3.54|<0.001
71018197|NCT02675426|141544049|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|20.8|||<|0.001|TWO_SIDED|95.0|13.6|28.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||28.1|13.6|<0.001
71018198|NCT02675426|141544049|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|18.4|||<|0.001|TWO_SIDED|95.0|11.2|25.5||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||25.5|11.2|<0.001
71018199|NCT02675426|141544050|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|21.3|||<|0.001|TWO_SIDED|95.0|13.0|29.5||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||29.5|13.0|<0.001
71018200|NCT02675426|141544050|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|23.0|||<|0.001|TWO_SIDED|95.0|14.7|31.3||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||31.3|14.7|<0.001
71018201|NCT02675426|141544051|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-51.01|||<|0.001|TWO_SIDED|95.0|-78.14|-23.87||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-23.87|-78.14|<0.001
71018202|NCT02675426|141544051|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-50.86|||<|0.001|TWO_SIDED|95.0|-78.19|-23.53||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-23.53|-78.19|<0.001
71018203|NCT02675426|141544052|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|4.95|||<|0.001|TWO_SIDED|95.0|3.31|6.6||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||6.60|3.31|<0.001
71018204|NCT02675426|141544052|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|4.78|||<|0.001|TWO_SIDED|95.0|3.12|6.44||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||6.44|3.12|<0.001
71018205|NCT02675426|141544053|SUPERIORITY||Response Rate Difference|23.1|||<|0.001|TWO_SIDED|95.0|15.1|31.0||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||31.0|15.1|<0.001
71018206|NCT02675426|141544053|SUPERIORITY||Response Rate Difference|28.4|||<|0.001|TWO_SIDED|95.0|20.4|36.5||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||36.5|20.4|<0.001
71105458|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
71018207|NCT02675426|141544054|SUPERIORITY||Response Rate Difference|14.9|||<|0.001|TWO_SIDED|95.0|8.7|21.1||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||21.1|8.7|<0.001
71018208|NCT02675426|141544054|SUPERIORITY||Response Rate Difference|20.6|||<|0.001|TWO_SIDED|95.0|14.0|27.2||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||27.2|14.0|<0.001
71018209|NCT02675426|141544055|SUPERIORITY||Response Rate Difference|13.6|||<|0.001|TWO_SIDED|95.0|7.0|20.2||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||20.2|7.0|<0.001
71018210|NCT02675426|141544055|SUPERIORITY||Response Rate Difference|19.7|||<|0.001|TWO_SIDED|95.0|12.7|26.7||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use|Response Rate Difference = Upadacitinib - Placebo|||26.7|12.7|<0.001
71018211|NCT04662086|141544086|OTHER|||||||0.2||||||A p-value of \<0.05 would be considered statistically significant.|Linear mixed-effects regression model|||A generalized linear mixed effects model with parameterization was utilized to capture the difference in change in viral shedding at day 10 between treatment arms. SARS-CoV2 viral RNA CT values were transformed using a standard Reference curve.||||0.20
71018212|NCT04662086|141544087|OTHER||Hazard Ratio (HR)|0.6||||0.07|TWO_SIDED|95.0|0.34|1.04||A p-value of \<0.05 would be considered statistically significant.|Cox proportional hazards model|Two-sided Cox proportional hazards model adjusted for age, sex, and receipt of baseline receipt of monoclonal antibodies.||A two-sided log rank test at the 0.04999 level of significance for the final analysis required 78 events (i.e., sustained symptom resolution) to provide 80% power to detect a hazard ratio of 1.91. Based on previous outpatient COVID-19 trials at Stanford, assumed placebo and treatment arm median time to symptom resolution of 10 and 5 days, respectively, for a total sample size of 120 patients. Participants with missing data lasting through Day 28 were censored on Day 28.||1.04|0.34|0.07
71018213|NCT04662086|141544089|OTHER||Hazard Ratio (HR)|0.62||||0.05|TWO_SIDED|95.0|0.38|1.01|||Linear mixed-effects regression model|||||1.01|0.38|0.05
71105459|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105460|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105461|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71018214|NCT04662086|141544090|OTHER||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.34|1.01||||||||1.01|0.34|
71018215|NCT04662086|141544091|OTHER|||||||0.21||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||Difference in incidence of ED visits||||0.21
71018216|NCT01856686|141544093|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56593|||||||ANCOVA|||Between-Group Comparison||||0.56593
71018217|NCT01856686|141544093|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44929|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.44929
71018218|NCT01856686|141544093|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81844|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.81844
71018219|NCT01856686|141544094|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71152|||||||ANCOVA|||Between-Group Comparison||||0.71152
71018220|NCT01856686|141544094|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27795|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.27795
71018221|NCT01856686|141544094|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47616|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.47616
71018222|NCT01856686|141544095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.10036|||||||ANCOVA|||Between-Group Comparison||||0.10036
71018223|NCT01856686|141544095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0082|||||||Paired t-test|||Within-group changes||||0.00820
71018224|NCT01856686|141544095|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||1.00000
71018225|NCT01856686|141544096|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92193|||||||ANCOVA|||Between-Group Comparison||||0.92193
71018226|NCT01856686|141544096|SUPERIORITY_OR_OTHER_LEGACY|||||||0.50704|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.50704
71018227|NCT01856686|141544096|SUPERIORITY_OR_OTHER_LEGACY|||||||0.42314|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.42314
71018228|NCT01856686|141544097|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08946|||||||ANCOVA|||Between-Group Comparison||||0.08946
71018229|NCT01856686|141544097|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27795|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.27795
71018230|NCT01856686|141544097|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0109|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.01090
71018231|NCT01856686|141544098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.73209|||||||ANCOVA|||Between-Group Comparison||||0.73209
71105462|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71051473|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.9|||<|0.001|TWO_SIDED|95.0|38.76|65.04|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||65.04|38.76|<0.001
71051474|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|42.94|||<|0.001|TWO_SIDED|95.0|29.44|56.44|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.44|29.44|<0.001
71105463|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105464|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.741||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.741
71105465|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.759||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.759
71105466|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.775||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.775
71105467|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.561||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.561
71105468|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.419||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.419
71105469|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.237||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.237
71105470|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.146||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.146
71105471|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.113||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.113
71051475|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.23||||0.048|TWO_SIDED|95.0|0.06|18.4|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.40|0.06|0.048
71105472|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.086||95.0||||"Analyaia at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.086
71105473|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.111||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.111
71105474|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.183||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.183
71051476|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.71|||<|0.001|TWO_SIDED|95.0|45.93|71.49|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.49|45.93|<0.001
71105475|NCT00402987|141718299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.259||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.259
71105476|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105477|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105478|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105479|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105480|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105481|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105482|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
70931883|NCT02307682|141364344|OTHER||Difference in proportions|2.5|||||TWO_SIDED|95.0|-4.0|9.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||9.5|-4.0|
71018232|NCT01856686|141544098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07965|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.07965
71018233|NCT01856686|141544098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61613|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.61613
71018234|NCT01856686|141544099|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33027|||||||ANCOVA|||Between-Group Comparison||||0.33027
71018235|NCT01856686|141544099|SUPERIORITY_OR_OTHER_LEGACY|||||||0.00013|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.00013
71018236|NCT01856686|141544099|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28019|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.28019
71018237|NCT01856686|141544100|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94449|||||||ANCOVA|||Between-Group Comparison||||0.94449
71018238|NCT01856686|141544100|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94574|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.94574
71018239|NCT01856686|141544100|SUPERIORITY_OR_OTHER_LEGACY|||||||0.85428|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.85428
71018240|NCT01856686|141544101|SUPERIORITY_OR_OTHER_LEGACY|||||||0.83929|||||||ANCOVA|||Between-Group Comparison||||0.83929
71051477|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.64||||0.105|TWO_SIDED|95.0|-1.38|14.67|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.67|-1.38|0.105
71051478|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.86|||<|0.001|TWO_SIDED|95.0|7.08|24.63|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||24.63|7.08|<0.001
71051479|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.9|||<|0.001|TWO_SIDED|95.0|38.76|65.04|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||65.04|38.76|<0.001
71051480|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|42.94|||<|0.001|TWO_SIDED|95.0|29.44|56.44|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.44|29.44|<0.001
71051481|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.23||||0.048|TWO_SIDED|95.0|0.06|18.4|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.40|0.06|0.048
71051482|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.71|||<|0.001||95.0|45.93|71.49|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||71.49|45.93|<0.001
71051483|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.64||||0.105|TWO_SIDED|95.0|-1.38|14.67|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||14.67|-1.38|0.105
71051484|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.23|||<|0.001|TWO_SIDED|95.0|6.48|23.97|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.97|6.48|<0.001
71051485|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.9|||<|0.001||95.0|38.76|65.04|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||65.04|38.76|<0.001
71051486|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.61|||<|0.001|TWO_SIDED|95.0|30.15|57.07|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||57.07|30.15|<0.001
71051487|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|8.61||||0.065|TWO_SIDED|95.0|-0.55|17.76|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||17.76|-0.55|0.065
71051488|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.71|||<|0.001||95.0|45.93|71.49|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.49|45.93|<0.001
71105483|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71018241|NCT01856686|141544101|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97213|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.97213
71018242|NCT01856686|141544101|SUPERIORITY_OR_OTHER_LEGACY|||||||0.58323|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.58323
71018243|NCT01856686|141544102|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05158|||||||ANCOVA|||Between-Group Comparison||||0.05158
71018244|NCT01856686|141544102|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94574|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.94574
70931884|NCT02307682|141364344|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-3.5|11.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||11.3|-3.5|
70931885|NCT02307682|141364344|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-5.9|8.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||8.2|-5.9|
71018245|NCT01856686|141544102|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09331|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.09331
70931886|NCT02307682|141364344|OTHER||Difference in proportions|3.9|||||TWO_SIDED|95.0|-3.4|11.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||11.2|-3.4|
70931887|NCT02307682|141364344|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-8.2|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||5.9|-8.2|
70931888|NCT02307682|141364344|OTHER||Difference in proportions|3.6|||||TWO_SIDED|95.0|-3.2|10.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||10.5|-3.2|
71018246|NCT01856686|141544103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17383|||||||ANCOVA|||Between-Group Comparison||||0.17383
71018247|NCT01856686|141544103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.00092|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.00092
71018248|NCT01856686|141544103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15544|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.15544
71018249|NCT01856686|141544104|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39707|||||||ANCOVA|||Between-Group Comparison||||0.39707
71018250|NCT01856686|141544104|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27945|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.27945
71018251|NCT01856686|141544104|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19739|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.19739
71018252|NCT01856686|141544105|SUPERIORITY_OR_OTHER_LEGACY|||||||0.50964|||||||ANCOVA|||Between-Group Comparison||||0.50964
71018253|NCT01856686|141544105|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0071|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.00710
71051489|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.64||||0.105|TWO_SIDED|95.0|-1.38|14.67|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.67|-1.38|0.105
71051490|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.98||||0.002|TWO_SIDED|95.0|5.3|22.67|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||22.67|5.30|0.002
71051491|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.9|||<|0.001|TWO_SIDED|95.0|38.76|65.04|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||65.04|38.76|<0.001
71051492|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|44.89|||<|0.001||95.0|31.51|58.26|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||58.26|31.51|<0.001
71051493|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.36||||0.113|TWO_SIDED|95.0|-1.73|16.45|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.45|-1.73|0.113
71051494|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|56.94|||<|0.001|TWO_SIDED|95.0|43.95|69.94|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||69.94|43.95|<0.001
71051495|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.07||||0.136|TWO_SIDED|95.0|-1.91|14.05|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.05|-1.91|0.136
71051496|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.98||||0.002|TWO_SIDED|95.0|5.3|22.67|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||22.67|5.30|0.002
71051497|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
71051498|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
71051499|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
71051500|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|56.94|||<|0.001|TWO_SIDED|95.0|43.95|69.94|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||69.94|43.95|<0.001
70931889|NCT02307682|141364344|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-7.3|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||6.8|-7.3|
71051501|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.07||||0.136|TWO_SIDED|95.0|-1.91|14.05|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.05|-1.91|0.136
71051502|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.98||||0.002|TWO_SIDED|95.0|5.3|22.67|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||22.67|5.30|0.002
70931890|NCT02307682|141364344|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-5.2|8.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||8.6|-5.2|
71051503|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
71051504|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
71105484|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
70941624|NCT04748445|141383934|OTHER||Slope|-0.1572|STANDARD_ERROR_OF_MEAN|9.127||0.0875|TWO_SIDED|90.0|-0.3084|-0.005942|||Mixed Models Analysis|||EE\_MFCC mean 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.005942|-0.3084|0.0875
71051505|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
71051506|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|56.94|||<|0.001|TWO_SIDED|95.0|43.95|69.94|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||69.94|43.95|<0.001
71051507|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.07||||0.136|TWO_SIDED|95.0|-1.91|14.05|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.05|-1.91|0.136
71051508|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.98||||0.002|TWO_SIDED|95.0|5.3|22.67|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||22.67|5.30|0.002
71051509|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
71051510|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
71105485|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71018254|NCT01856686|141544105|SUPERIORITY_OR_OTHER_LEGACY|||||||0.00595|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.00595
71018255|NCT01856686|141544106|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48336|||||||ANCOVA|||Between-Group Comparison||||0.48336
71018256|NCT01856686|141544106|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08739|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.08739
71018257|NCT01856686|141544106|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37046|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.37046
71018258|NCT01856686|141544108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45013|||||||ANCOVA|||Between-Group Comparison||||0.45013
71018259|NCT01856686|141544108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17374|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.17374
71018260|NCT01856686|141544108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07548|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.07548
71018261|NCT01856686|141544109|SUPERIORITY_OR_OTHER_LEGACY|||||||0.23226|||||||ANCOVA|||Between-Group Comparison||||0.23226
71018262|NCT01856686|141544109|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08812|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.08812
71018263|NCT01856686|141544109|SUPERIORITY_OR_OTHER_LEGACY|||||||0.00776|||||||Pairedt-test|||Within-group comparisons between the baseline and 3 month data||||0.00776
71018264|NCT01856686|141544110|SUPERIORITY_OR_OTHER_LEGACY|||||||0.90843|||||||ANCOVA|||Between-Group Comparison||||0.90843
71018265|NCT01856686|141544110|SUPERIORITY_OR_OTHER_LEGACY|||||||0.00413|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.00413
71018266|NCT01856686|141544110|SUPERIORITY_OR_OTHER_LEGACY|||||||0.00775|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.00775
71018267|NCT02216214|141544174|SUPERIORITY||Least Squares Mean (LSM) Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.05|-0.33||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and baseline value as a covariate.||-0.33|-1.05|<0.001
71018268|NCT02216214|141544175|SUPERIORITY||LSM Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.82|-0.27||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and baseline value as a covariate.||-0.27|-0.82|<0.001
71018269|NCT02216214|141544176|SUPERIORITY||LSM Difference|13.68|STANDARD_ERROR_OF_MEAN|4.45||0.002|TWO_SIDED|95.0|4.95|22.42||P-value compares the Mirabegron group to the placebo group.|stratified rank ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the stratified rank ANCOVA model with treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and baseline value as a covariate.||22.42|4.95|0.002
71018270|NCT02216214|141544177|SUPERIORITY||LSM Difference|-5.15|STANDARD_ERROR_OF_MEAN|1.37|<|0.001|TWO_SIDED|95.0|-7.84|-2.46||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and baseline value as a covariate.||-2.46|-7.84|<0.001
71051511|NCT02912650|141608115|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
71051512|NCT02912650|141608116|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.||||<0.001
71051513|NCT02912650|141608116|SUPERIORITY_OR_OTHER|||||||0.004|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.||||0.004
71051514|NCT02912650|141608116|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.||||<0.001
71018271|NCT02216214|141544178|SUPERIORITY||LSM Difference|2.72|STANDARD_ERROR_OF_MEAN|1.07||0.011|TWO_SIDED|95.0|0.62|4.83||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and baseline value as a covariate.||4.83|0.62|0.011
71018272|NCT02216214|141544179|SUPERIORITY||LSM Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.46|-0.16||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and baseline value as a covariate.||-0.16|-0.46|<0.001
71018273|NCT02216214|141544180|SUPERIORITY||||||<|0.001||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||<0.001
71018274|NCT02216214|141544181|SUPERIORITY||Rate Ratio|0.68|||<|0.001||||||P-value compares the Mirabegron group to the placebo group.|Negative Binomial Regression Model|||The rate ratio for the number of urgency incontinence episodes reported during 3-day diary prior to each visit between mirabegron total group vs placebo group was calculated from a negative binomial regression model including treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and number of valid diary days as the offset variable.||||<0.001
71018275|NCT02216214|141544182|SUPERIORITY||Rate Ratio|0.84||||0.432||||||P-value compares the Mirabegron group to the placebo group.|Negative Binomial Regression Model|||The rate ratio for the number of nocturia episodes reported during 3-day diary prior to each visit between mirabegron total group vs placebo group is calculated from a negative binomial regression model including treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and number of valid diary days as the offset variable.||||0.432
71018276|NCT02216214|141544183|SUPERIORITY|||||||0.317||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||0.317
70931891|NCT02307682|141364344|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-7.8|6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||6.6|-7.8|
70931892|NCT02307682|141364344|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-4.8|10.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||10.0|-4.8|
71018277|NCT02216214|141544184|SUPERIORITY|||||||0.165||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||0.165
70931893|NCT02307682|141364344|OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-4.4|9.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||9.2|-4.4|
70931894|NCT02307682|141364344|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-7.1|7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||7.2|-7.1|
70931895|NCT02307682|141364344|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-7.9|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||6.2|-7.9|
71018278|NCT02216214|141544185|SUPERIORITY||||||<|0.001||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||<0.001
71051515|NCT02912650|141608116|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.||||<0.001
70931896|NCT02307682|141364344|OTHER||Difference in proportions|2.4|||||TWO_SIDED|95.0|-4.5|9.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||9.2|-4.5|
70931897|NCT02307682|141364344|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-6.8|8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||8.1|-6.8|
70931898|NCT02307682|141364344|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-5.8|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||8.4|-5.8|
70931899|NCT02307682|141364344|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-6.1|8.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||8.2|-6.1|
70931900|NCT02307682|141364344|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-8.6|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||5.6|-8.6|
71018279|NCT02216214|141544186|SUPERIORITY|||||||0.019||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Coping Subscale Score||||0.019
71018280|NCT02216214|141544186|SUPERIORITY|||||||0.01||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Concern Subscale Score||||0.010
71018281|NCT02216214|141544186|SUPERIORITY|||||||0.006||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Sleep Subscale Score||||0.006
71018282|NCT02216214|141544186|SUPERIORITY|||||||0.614||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Social Subscale Score||||0.614
71018283|NCT02216214|141544187|SUPERIORITY|||||||0.002||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||0.002
71018284|NCT02216214|141544188|SUPERIORITY|||||||0.755||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||0.755
71051516|NCT02912650|141608116|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.||||<0.001
71105486|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71018285|NCT02216214|141544189|SUPERIORITY||Rate Ratio|0.8||||0.014|TWO_SIDED|95.0|0.67|0.96||P-value compares the Mirabegron group to the placebo group.|Negative Binomial Regression Model|||Week 4: Rate ratio for the number of incontinence episodes reported during 3-day diary prior to each visit between mirabegron group vs placebo group is calculated from a negative binomial regression model including treatment group, sex, age group (\<75, \>=75 years) and country as factors and number of valid diary days as the offset variable.||0.96|0.67|0.014
71051517|NCT02912650|141608116|SUPERIORITY_OR_OTHER|||||||0.003|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.||||0.003
71051518|NCT00922987|141608162|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||||||<0.0001
71105487|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105488|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.017||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.017
71018286|NCT02216214|141544189|SUPERIORITY||Rate Ratio|0.81||||0.043|TWO_SIDED|95.0|0.66|0.99||P-value compares the Mirabegron group to the placebo group.|Negative Binomial Regression Model|||Week 8: Rate ratio for the number of incontinence episodes reported during 3-day diary prior to each visit between mirabegron group vs placebo group is calculated from a negative binomial regression model including treatment group, sex, age group (\<75, \>=75 years) and country as factors and number of valid diary days as the offset variable.||0.99|0.66|0.043
71018287|NCT02216214|141544189|SUPERIORITY||Rate Ratio|0.69||||0.002|TWO_SIDED|95.0|0.54|0.87||P-value compares the Mirabegron group to the placebo group.|Negative Binomial Regression Model|||EOT: Rate ratio for the number of incontinence episodes reported during 3-day diary prior to each visit between mirabegron group vs placebo group is calculated from a negative binomial regression model including treatment group, sex, age group (\<75, \>=75 years) and country as factors and number of valid diary days as the offset variable.||0.87|0.54|0.002
71018288|NCT02216214|141544191|SUPERIORITY||Odds Ratio (OR)|1.5||||0.005||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.005
71018289|NCT02216214|141544192|SUPERIORITY||Odds Ratio (OR)|1.775|||<|0.001||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||<0.001
71018290|NCT02216214|141544193|SUPERIORITY||Odds Ratio (OR)|1.501||||0.012||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.012
71018291|NCT02216214|141544194|SUPERIORITY||Odds Ratio (OR)|1.39||||0.034||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||HRQL Subscale - Coping. Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.034
71018292|NCT02216214|141544194|SUPERIORITY||Odds Ratio (OR)|1.327||||0.07||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||HRQL Subscale - Concern. Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.070
71018293|NCT02216214|141544194|SUPERIORITY||Odds Ratio (OR)|1.452||||0.012||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||HRQL Subscale - Sleep. Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.012
71018294|NCT02216214|141544194|SUPERIORITY||Odds Ratio (OR)|1.116||||0.602||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||HRQL Subscale - Social. Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.602
71018295|NCT02216214|141544195|SUPERIORITY||Odds Ratio (OR)|1.634||||0.001||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.001
71018296|NCT02216214|141544196|SUPERIORITY||Odds Ratio (OR)|1.597||||0.003||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.003
71018297|NCT02216214|141544198|SUPERIORITY|||||||0.471||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||0.471
71018298|NCT00713830|141544200|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.74|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001|TWO_SIDED|95.0|-0.867|-0.621||Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0, \>=8.0%), metformin use (yes, no), country as fixed effects, baseline HbA1c as covariate.|ANCOVA|||To detect a difference of 0.5% (or 0.4%) in change from baseline to Week 24 in HbA1c between lixisenatide and placebo, 570 patients in lixisenatide arm and 285 in placebo arm would provide a power of 99% (or 98%) assuming common standard deviation of 1.3% with a 2-sided test at 5% significance level.||-0.621|-0.867|<0.0001
71018299|NCT02115373|141544255|OTHER||Median|2.07|||||TWO_SIDED|90.0|1.446|7.195|||||TTP in months was calculated for Phase 1b: Tepotinib 300 mg and Phase 1b: Tepotinib 500 mg combined.|||7.195|1.446|
71018300|NCT02115373|141544255|OTHER||Median|3.98|||||TWO_SIDED|90.0|2.858|4.238|||||TTP in months was calculated for Phase 2: Tepotinib 500 mg.|||4.238|2.858|
71018301|NCT02115373|141544256|OTHER||Median|1.51|||||TWO_SIDED|90.0|1.413|3.68|||||PFS time in months was calculated for Phase 1b: Tepotinib 300 mg and Phase 1b: Tepotinib 500 mg combined.|||3.680|1.413|
71018302|NCT02115373|141544256|OTHER||Median|3.22|||||TWO_SIDED|90.0|0.03|16.53|||||PFS time in months was calculated for Phase 2: Tepotinib 500 mg.|||16.53|0.03|
71018303|NCT02115373|141544257|OTHER||Median|1.48|||||TWO_SIDED|90.0|1.413|3.844|||||PFS time in months was calculated for Phase 1b: Tepotinib 300 mg and Phase 1b: Tepotinib 500 mg combined.|||3.844|1.413|
71018304|NCT02115373|141544257|OTHER||Median|3.35|||||TWO_SIDED|90.0|2.76|4.172|||||PFS time in months was was calculated for Phase 2: Tepotinib 500 mg.|||4.172|2.760|
71105489|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.011
71105490|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.009
71105491|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.008
70931901|NCT02307682|141364344|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-7.0|7.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||7.1|-7.0|
70931902|NCT02307682|141364344|OTHER||Difference in proportions|3.4|||||TWO_SIDED|95.0|-3.5|11.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||11.0|-3.5|
70931903|NCT02307682|141364344|OTHER||Difference in proportions|4.0|||||TWO_SIDED|95.0|-3.0|10.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||10.8|-3.0|
70931904|NCT02307682|141364344|OTHER||Difference in proportions|5.5|||||TWO_SIDED|95.0|-1.4|13.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||13.0|-1.4|
70931905|NCT02307682|141364344|OTHER||Difference in proportions|2.7|||||TWO_SIDED|95.0|-4.1|9.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||9.5|-4.1|
70931906|NCT02307682|141364344|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-4.8|9.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||9.7|-4.8|
70931907|NCT02307682|141364344|OTHER||Difference in proportions|5.2|||||TWO_SIDED|95.0|-1.6|12.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||12.3|-1.6|
70931908|NCT02307682|141364344|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-5.4|8.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||8.6|-5.4|
70931909|NCT02307682|141364344|OTHER||Difference in proportions|2.5|||||TWO_SIDED|95.0|-4.8|9.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||9.4|-4.8|
70931910|NCT02307682|141364344|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-5.0|8.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||8.2|-5.0|
71018305|NCT02115373|141544259|OTHER||Median|7.2|||||TWO_SIDED|90.0|3.68|10.119|||||Overall Survival time in months was calculated for Phase 1b: Tepotinib 300 mg and Phase 1b: Tepotinib 500 mg combined.|||10.119|3.680|
71018306|NCT02115373|141544259|OTHER||Median|5.55|||||TWO_SIDED|90.0|5.092|8.181|||||Overall Survival time in months was calculated for Phase 2: Tepotinib 500 mg.|||8.181|5.092|
71018307|NCT03747939|141544280|SUPERIORITY||Adjusted difference in proportions|18.5||||0.0008|TWO_SIDED|95.0|8.9|28.1|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per Interactive Web Response System (IWRS) data, using Cochran-Mantel-Haenszel (CMH) weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||28.1|8.9|0.0008
71018308|NCT03747939|141544281|SUPERIORITY||Adjusted difference in proportions|18.6||||0.0017|TWO_SIDED|95.0|7.0|30.2|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per IWRS data, using CMH weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||30.2|7.0|0.0017
71105492|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.008
71105493|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.008
71105494|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.008
71051519|NCT05091307|141608170|NON_INFERIORITY|The criterion for non-inferiority (NI) was the upper bound of the 2-sided 95% CI for the GMR was below 1.5.|Geometric Mean Ratio|1.28|||||TWO_SIDED|95.0|1.09|1.53|||ANOVA|||A/Victoria (H1N1): Based on analysis of variance (ANOVA) models, CIs around the difference (Group 2 \[control group\] minus Group 1 \[CoAd group\]) was calculated and back-transformed (by exponentiation: 2\^CI) to CIs around a geometric mean ratio (GMR: GMTControl/GMTCoAd).||1.53|1.09|
70931911|NCT02307682|141364344|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-6.9|7.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||7.4|-6.9|
71018309|NCT03747939|141544282|SUPERIORITY||Adjusted difference in proportions|5.1||||0.3539|TWO_SIDED|95.0|-5.8|16.0|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per IWRS data, using CMH weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||16.0|-5.8|0.3539
71018310|NCT03747939|141544283|SUPERIORITY||Adjusted difference in proportions|22.1||||0.0003|TWO_SIDED|95.0|10.4|33.7|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per IWRS data, using CMH weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||33.7|10.4|0.0003
71018311|NCT03747939|141544284|SUPERIORITY||Adjusted difference in proportions|11.8||||0.0286|TWO_SIDED|95.0|1.7|22.0|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per IWRS data, using CMH weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||22.0|1.7|0.0286
71018312|NCT03747939|141544285|SUPERIORITY||Adjusted difference in proportions|16.3||||0.0022|TWO_SIDED|95.0|6.9|25.8|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per IWRS data, using CMH weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||25.8|6.9|0.0022
71018313|NCT03747939|141544286|SUPERIORITY||Difference in LS means|-1.03|||<|0.0001|TWO_SIDED|95.0|-1.48|-0.59|||MMRM||Apremilast - Placebo|Difference in LS means is based MMRM of the change from baseline.||-0.59|-1.48|<0.0001
71018314|NCT03747939|141544287|SUPERIORITY||Adjusted difference in proportions|17.7||||0.0043|TWO_SIDED|95.0|5.7|29.7|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per IWRS data, using CMH weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||29.7|5.7|0.0043
71018315|NCT01215955|141544288|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|||||TWO_SIDED|95.0|-0.15|0.22|||||No imputation was performed. Participants without a 24-week value were handled by the statistical model.|||0.22|-0.15|
71018316|NCT01215955|141544288|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|||||TWO_SIDED|95.0|-0.12|0.24|||||No imputation was performed. Participants without a 24-week value were handled by the statistical model.|||0.24|-0.12|
71018317|NCT01215955|141544289|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.128|TWO_SIDED|95.0|0.52|1.09||P-value is for HbA1c ≤7.0% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|||||1.09|0.520|0.128
71018318|NCT01215955|141544289|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.625|TWO_SIDED|95.0|0.58|1.39||P-value is for HbA1c ≤6.5% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|||||1.39|0.580|0.625
71018319|NCT01215955|141544289|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.162|TWO_SIDED|95.0|0.53|1.11||P-value is for HbA1c ≤7.0% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|||||1.11|0.53|0.162
71018320|NCT01215955|141544289|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.723|TWO_SIDED|95.0|0.61|1.4||P-value is for HbA1c ≤6.5% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Linear|||||1.40|0.61|0.723
71051520|NCT05091307|141608170|NON_INFERIORITY|The criterion for NI was the upper bound of the 2-sided 95% CI for the GMR was below 1.5.|Geometric Mean Ratio|1.23|||||TWO_SIDED|95.0|1.05|1.45|||ANOVA|||A/Cambodia (H3N2): Based on analysis of variance (ANOVA) models, CIs around the difference (Group 2 \[control group\] minus Group 1 \[CoAd group\]) was calculated and back-transformed (by exponentiation: 2\^CI) to CIs around a geometric mean ratio (GMR: GMTControl/GMTCoAd).||1.45|1.05|
71051521|NCT05091307|141608170|NON_INFERIORITY|The criterion for NI was the upper bound of the 2-sided 95% CI for the GMR was below 1.5.|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.84|1.19|||ANOVA|||B/Victoria (B/Victoria): Based on analysis of variance (ANOVA) models, CIs around the difference (Group 2 \[control group\] minus Group 1 \[CoAd group\]) was calculated and back-transformed (by exponentiation: 2\^CI) to CIs around a geometric mean ratio (GMR: GMTControl/GMTCoAd).||1.19|0.84|
71051522|NCT05091307|141608170|NON_INFERIORITY|The criterion for NI was the upper bound of the 2-sided 95% CI for the GMR was below 1.5.|Geometric Mean Ratio|1.03|||||TWO_SIDED|95.0|0.88|1.21|||ANOVA|||B/Phuket (B/Yamagata): Based on analysis of variance (ANOVA) models, CIs around the difference (Group 2 \[control group\] minus Group 1 \[CoAd group\]) was calculated and back-transformed (by exponentiation: 2\^CI) to CIs around a geometric mean ratio (GMR: GMTControl/GMTCoAd).||1.21|0.88|
71051523|NCT05091307|141608171|NON_INFERIORITY|The criterion for NI was the upper bound of the 2-sided 95% CI for the GMR was below 1.5.|Geometric Mean Ratio|1.11|||||TWO_SIDED|95.0|0.97|1.26|||ANOVA|||Based on analysis of variance (ANOVA) models, CIs around the difference (Group 2 \[control group\] minus Group 1 \[CoAd group\]) was calculated and back-transformed (by exponentiation: 2\^CI) to CIs around a geometric mean ratio (GMR: GMTControl/GMTCoAd).||1.26|0.97|
71105495|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.012
71051524|NCT02906930|141608206|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.9||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.9|-1.3|<0.0001
71051525|NCT02906930|141608206|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.6||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 7 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.6|-1.1|<0.0001
71105496|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.904||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.904
71105497|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.891||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.891
71105498|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.929||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.929
71105499|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.994||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.994
70931912|NCT02307682|141364344|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-5.1|8.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||8.5|-5.1|
70931913|NCT02307682|141364344|OTHER||Difference in proportions|3.0|||||TWO_SIDED|95.0|-3.9|10.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||10.1|-3.9|
70931914|NCT02307682|141364344|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-5.0|9.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||9.1|-5.0|
70931915|NCT02307682|141364344|OTHER||Difference in proportions|4.6|||||TWO_SIDED|95.0|-2.5|11.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||11.8|-2.5|
70931916|NCT02307682|141364344|OTHER||Difference in proportions|3.3|||||TWO_SIDED|95.0|-3.4|10.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||10.6|-3.4|
70931917|NCT02307682|141364344|OTHER||Difference in proportions|5.1|||||TWO_SIDED|95.0|-1.6|12.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||12.2|-1.6|
71051526|NCT02906930|141608206|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.4||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 3 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.4|-0.8|<0.0001
71051527|NCT02906930|141608206|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-0.7|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral Semaglutide 3 mg - placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.5|-0.9|<0.0001
71051528|NCT02906930|141608206|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral Semaglutide 7 mg - placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.0|-1.5|<0.0001
70931918|NCT02307682|141364344|OTHER||Difference in proportions|3.9|||||TWO_SIDED|95.0|-3.0|11.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||11.2|-3.0|
70931919|NCT02307682|141364344|OTHER||Difference in proportions|5.6|||||TWO_SIDED|95.0|-1.9|12.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||12.7|-1.9|
70931920|NCT02307682|141364344|OTHER||Difference in proportions|5.7|||||TWO_SIDED|95.0|-1.0|12.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||12.6|-1.0|
71105500|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.933||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.933
71105501|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.876||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.876
71105502|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.622||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.622
70931921|NCT02307682|141364345|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-7.7|6.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||6.0|-7.7|
71018321|NCT01215955|141544290|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.701|TWO_SIDED|95.0|0.52|2.67||P-value is for HbA1c ≤7.0% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|||||2.67|0.520|0.701
71051529|NCT02906930|141608206|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.7|-1.2||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral Semaglutide 14 mg - placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.2|-1.7|<0.0001
71018322|NCT01215955|141544290|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.249|TWO_SIDED|95.0|0.71|3.7||P-value is for HbA1c ≤6.5% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|||||3.70|0.710|0.249
71018323|NCT01215955|141544290|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32||||0.015|TWO_SIDED|95.0|0.13|0.8||P-value is for HbA1c ≤7% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|Included treatment and effects for baseline stratification variables: Baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use.||||0.80|0.13|0.015
71018324|NCT01215955|141544290|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.078|TWO_SIDED|95.0|0.17|1.1||P-value is for HbA1c ≤6.5% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|||||1.10|0.17|0.078
71018325|NCT01215955|141544291|SUPERIORITY_OR_OTHER||LS Mean Differences|0.81||||0.014|TWO_SIDED|95.0|0.17|1.46||No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||1.46|0.17|0.014
71018326|NCT01215955|141544291|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.5||||0.108|TWO_SIDED|95.0|-1.12|0.11||No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||0.11|-1.12|0.108
71018327|NCT01215955|141544292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.182|TWO_SIDED|95.0|0.57|1.11||Comparison is calculated as Q3D versus Q1D.|Regression, Cox|Cox Regression model with effects for treatment and baseline stratification variables (HbA1c, country, sulfonylurea/meglitinide use) was used.||||1.11|0.57|0.182
71018328|NCT01215955|141544292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.46|TWO_SIDED|95.0|0.65|1.22||Comparison is calculated as Q3D versus Q1D.|Regression, Cox|Cox Regression model with effects for treatment and baseline stratification variables (HbA1c, country, sulfonylurea/meglitinide use) was used.||||1.22|0.65|0.460
71018329|NCT01215955|141544293|SUPERIORITY_OR_OTHER||LS Mean Differences|0.29|||||TWO_SIDED|95.0|-0.19|0.77|||||No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|||0.77|-0.19|
71077905|NCT02913105|141664398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.9572|TWO_SIDED|90.0|0.88|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 28||1.12|0.88|0.9572
71018330|NCT01215955|141544293|SUPERIORITY_OR_OTHER||LS Mean Differences|0.81|||||TWO_SIDED|95.0|0.3|1.31|||||No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|||1.31|0.30|
71018331|NCT01215955|141544294|SUPERIORITY_OR_OTHER||LS Mean Differences|0.59||||0.242|TWO_SIDED|95.0|-0.4|1.58||Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||No imputation was performed. Participants without a 24-week value were handled by the statistical model.|||1.58|-0.40|0.242
71018332|NCT01215955|141544294|SUPERIORITY_OR_OTHER||LS Mean Differences|1.13||||0.082|TWO_SIDED|95.0|-0.15|2.41||Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||No imputation was performed. Participants without 24-week values were handled by the statistical model.|||2.41|-0.15|0.082
71018333|NCT01215955|141544295|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.15||||0.723|TWO_SIDED|95.0|-0.95|0.66||Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||No imputation was performed. Participants without a 24-week value were handled by the statistical model|||0.66|-0.95|0.723
71018334|NCT01215955|141544295|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.28||||0.495|TWO_SIDED|95.0|-1.08|0.52||Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||No imputation was performed. Participants without a 24-week value were handled by the statistical model|||0.52|-1.08|0.495
71018335|NCT01215955|141544296|SUPERIORITY_OR_OTHER||LS Mean Difference|3.32||||0.245|TWO_SIDED|95.0|-2.28|8.93||P-value is for Morning Pre-meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||8.93|-2.28|0.245
71018336|NCT01215955|141544296|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.71||||0.842|TWO_SIDED|95.0|-7.71|6.29||P-value is for Morning 2-HR PP. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||6.29|-7.71|0.842
71018337|NCT01215955|141544296|SUPERIORITY_OR_OTHER||LS Mean Difference|1.42||||0.626||95.0|-4.32|7.16||P-value is for Midday Pre-Meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||7.16|-4.32|0.626
71018338|NCT01215955|141544296|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.48||||0.358|TWO_SIDED|95.0|-10.91|3.95||P-value is for Midday 2-Hr PP. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||3.95|-10.91|0.358
71018339|NCT01215955|141544296|SUPERIORITY_OR_OTHER||LS Mean Difference|3.38||||0.322|TWO_SIDED|95.0|-3.32|10.07||P-value is for Evening Pre-meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||10.07|-3.32|0.322
71018340|NCT01215955|141544296|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.25||||0.617|TWO_SIDED|95.0|-11.08|6.58||P-value is for Bed Time. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||6.58|-11.08|0.617
71018341|NCT01215955|141544296|SUPERIORITY_OR_OTHER||LS Mean Difference|2.37||||0.519|TWO_SIDED|95.0|-4.86|9.6||P-value is for 0300 hours. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||9.60|-4.86|0.519
71018342|NCT01215955|141544296|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1||||0.415|TWO_SIDED|95.0|-2.96|7.15||P-value is for Morning Pre-meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||7.15|-2.96|0.415
71018343|NCT01215955|141544296|SUPERIORITY_OR_OTHER||LS Mean Difference|4.38||||0.198|TWO_SIDED|95.0|-2.3|11.06||P-value is for Morning 2-hr PP. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||11.06|-2.30|0.198
71018344|NCT01215955|141544296|SUPERIORITY_OR_OTHER||LS Mean Difference|6.22||||0.045|TWO_SIDED|95.0|0.14|12.29||P-value is for Midday Pre-Meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||12.29|0.14|0.045
71018345|NCT01215955|141544296|SUPERIORITY_OR_OTHER||LS Mean Difference|3.07||||0.426|TWO_SIDED|95.0|-4.5|10.64||P-value is for Midday 2-hr PP. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||10.64|-4.50|0.426
71018346|NCT01215955|141544296|SUPERIORITY_OR_OTHER||LS Mean Difference|5.66||||0.14|TWO_SIDED|95.0|-1.86|13.17||P-value is for Evening Pre-Meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||13.17|-1.86|0.140
71051530|NCT02906930|141608207|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.1|-1.5||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-1.5|-3.1|<0.0001
71077906|NCT02913105|141664398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.98||||0.7372|TWO_SIDED|90.0|0.87|1.1|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 42||1.10|0.87|0.7372
71018347|NCT01215955|141544296|SUPERIORITY_OR_OTHER||LS Mean Difference|11.18||||0.02|TWO_SIDED|95.0|1.74|20.63||P-value is for Bed Time. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||20.63|1.74|0.020
71018348|NCT01215955|141544296|SUPERIORITY_OR_OTHER||LS Mean Difference|9.01||||0.037|TWO_SIDED|95.0|0.53|17.49||P-value is for 0300 hours. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||17.49|0.53|0.037
71077907|NCT02913105|141664398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.04||||0.6015|TWO_SIDED|90.0|0.92|1.17|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 56||1.17|0.92|0.6015
70931922|NCT02307682|141364345|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-5.3|8.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||8.7|-5.3|
70931923|NCT02307682|141364345|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-7.4|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||6.8|-7.4|
71051531|NCT02906930|141608207|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.9||||0.0866|TWO_SIDED|95.0|-1.9|0.1||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 7 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.1|-1.9|0.0866
71051532|NCT02906930|141608207|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.1||||0.8692|TWO_SIDED|95.0|-0.9|0.8||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 3 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.8|-0.9|0.8692
71051533|NCT02906930|141608207|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-0.2||||0.7075|TWO_SIDED|95.0|-1.0|0.6|||MMRM||Oral Semaglutide 3 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||0.6|-1.0|0.7075
71051534|NCT02906930|141608207|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-1.0||||0.0138|TWO_SIDED|95.0|-1.8|-0.2||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral Semaglutide 7 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.2|-1.8|0.0138
70931924|NCT02307682|141364345|OTHER||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-8.9|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||5.3|-8.9|
71051535|NCT02906930|141608207|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.4|-1.8||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral Semaglutide 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.8|-3.4|<0.0001
71051536|NCT02906930|141608230|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.45||||0.0043|TWO_SIDED|95.0|0.26|0.78||Unadjusted two-sided p-value for test of no difference from 1|Regression, Cox||Oral Semaglutide 3 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.78|0.26|0.0043
71105503|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.081||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.081
70851167|NCT00669409|141190514|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-9.1|22.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||22.5|-9.1|
70851168|NCT00669409|141190514|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-31.7|-0.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-0.2|-31.7|
71051537|NCT02906930|141608230|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.33||||0.0002|TWO_SIDED|95.0|0.18|0.59||Unadjusted two-sided p-value for test of no difference from 1|Regression, Cox||Oral Semaglutide 7 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.59|0.18|0.0002
71051538|NCT02906930|141608230|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.33||||0.0002|TWO_SIDED|95.0|0.19|0.6||Unadjusted two-sided p-value for test of no difference from 1|Regression, Cox||Oral Semaglutide 14 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.60|0.19|0.0002
71051539|NCT02906930|141608231|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.48||||0.03|TWO_SIDED|95.0|0.25|0.93||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 3 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.93|0.25|0.0300
71051540|NCT02906930|141608231|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.13||||0.0001|TWO_SIDED|95.0|0.04|0.36||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 7 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.36|0.04|0.0001
71051541|NCT02906930|141608231|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.06||||0.0001|TWO_SIDED|95.0|0.01|0.26||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 14 mg /Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.26|0.01|0.0001
71051542|NCT04796779|141608258|SUPERIORITY||||||<|0.001|||||||Direct likelihood model|The model was adjusted for the baseline value of the metric, age, prior CGM and pump use, and site as a random effect.||||||<0.001
71051543|NCT04796779|141608259|SUPERIORITY||||||<|0.001||||||To preserve the overall type I error for the multiple secondary outcomes, a hierarchical gatekeeping approach was used.|Robust regression using M-estimation|The model was adjusted for baseline value of the metric, age, prior CGM and pump use, and site as a fixed effect.||||||<0.001
71051544|NCT04796779|141608260|SUPERIORITY||||||<|0.001||||||To preserve the overall type I error for the multiple secondary outcomes, a hierarchical gatekeeping approach was used.|Direct likelihood model|The model was adjusted for the baseline value of the metric, age, prior CGM and pump use, and site as a random effect.||||||<0.001
71051545|NCT04796779|141608261|SUPERIORITY||||||<|0.001||||||To preserve the overall type I error for the multiple secondary outcomes, a hierarchical gatekeeping approach was used.|Direct likelihood model|The model was adjusted for the baseline value of the metric, age, prior CGM and pump use, and site as a random effect.||||||<0.001
71051546|NCT04796779|141608262|SUPERIORITY|||||||0.57||||||To preserve the overall type I error for the multiple secondary outcomes, a hierarchical gatekeeping approach was used.|Robust regression using M-estimation|The model was adjusted for the baseline value of the metric, age, prior CGM and pump use, and site as a fixed effect.||||||0.57
71051547|NCT01659866|141608318|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
71051548|NCT00894738|141608363|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED|||||The p-value listed is for DEXA total percent fat and is not adjusted for multiple comparisons. The alpha level was set to 5%.|ANCOVA|||The null hypothesis is that mean DEXA total percent fat is similar between the two groups of interest. The primary statistical model consisted of treatment group as a 2-level factor (AP-Treated Vs Non-AP Treated) and DEXA total percent fat as a covariate. Carotid intima-media thickness (CIMT) was the dependent variable.||||0.49
70931925|NCT02307682|141364345|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-8.1|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||5.9|-8.1|
71051549|NCT00894738|141608364|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The p-value listed is for DEXA total percent fat and is not adjusted for multiple comparisons. The alpha level was set to 5%.|ANCOVA|||The statistical analysis consisted of treatment group as a 2-level factor variable and DEXA total percent fat as a covariate. An interaction term between treatment group and DEXA total percent fat was also generated. Hepatic triglyceride content was the dependent variable. DEXA total percent fat was found to be significant while treatment group and the interaction between treatment group and DEXA total percent fat were not significant.||||<0.0001
71051550|NCT01383135|141608369|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034||||||GraphPad (GraphPad Software, San Diego, Calif) was used for the paired two-sample t test and was performed to compare SUVmax values. P \< .05 was considered to indicate a significant difference|t-test, 2 sided|||Comparison made between baseline tumor values and tumor values 6-weeks post-bevacizumab therapy||||.034
71051551|NCT03397771|141608379|OTHER||Odds Ratio (OR)|1.0||||0.963|TWO_SIDED||||||Regression, Logistic|||||||0.963
71051552|NCT03397771|141608380|NON_INFERIORITY|The analysis was conducted according to the nul hypothesis, assuming no difference between treatment arms||||||0.022|||||||ANCOVA|||||||0.022
71051553|NCT03801265|141608381|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||.770
71105504|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.117||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.117
70931926|NCT02307682|141364345|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-4.8|8.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||8.8|-4.8|
70931927|NCT02307682|141364345|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-9.8|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||4.7|-9.8|
70931928|NCT02307682|141364345|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-5.3|8.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||8.6|-5.3|
70931929|NCT02307682|141364345|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-9.7|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||3.6|-9.7|
70931930|NCT02307682|141364345|OTHER||Difference in proportions|-4.1|||||TWO_SIDED|95.0|-11.4|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||3.3|-11.4|
71051554|NCT03801265|141608382|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.826|||||||Wilcoxon (Mann-Whitney)|||||||.826
71051555|NCT03801265|141608383|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.859|||||||Wilcoxon (Mann-Whitney)|||||||.859
70931931|NCT02307682|141364345|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-7.6|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||6.1|-7.6|
70931932|NCT02307682|141364345|OTHER||Difference in proportions|2.5|||||TWO_SIDED|95.0|-4.4|10.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||10.0|-4.4|
70931933|NCT02307682|141364345|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-7.2|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||6.9|-7.2|
70931934|NCT02307682|141364345|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-6.3|7.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||7.8|-6.3|
71051556|NCT03801265|141608384|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.904|||||||Wilcoxon (Mann-Whitney)|||||||.904
71051557|NCT03801265|141608385|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.122|||||||Wilcoxon (Mann-Whitney)|||||||.122
71051558|NCT03801265|141608386|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.379|||||||Wilcoxon (Mann-Whitney)|||||||.379
71051559|NCT03801265|141608387|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.881|||||||Wilcoxon (Mann-Whitney)|||||||.881
71105505|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.152||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.152
71105506|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.171||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.171
71105507|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.197||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.197
71105508|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.244||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.244
70931935|NCT02307682|141364345|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-4.7|9.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||9.2|-4.7|
70931936|NCT02307682|141364345|OTHER||Difference in proportions|3.1|||||TWO_SIDED|95.0|-3.9|10.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||10.3|-3.9|
71051560|NCT03801265|141608388|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.818|||||||Wilcoxon (Mann-Whitney)|||||||.818
71051561|NCT03801265|141608389|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.678|||||||Wilcoxon (Mann-Whitney)|||||||.678
71051562|NCT03801265|141608390|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||.002
71051563|NCT03801265|141608391|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.007|||||||Chi-squared|||||||.007
71051564|NCT03801265|141608392|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.271|||||||Wilcoxon (Mann-Whitney)|||||||.271
71051565|NCT03801265|141608393|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.81|||||||Wilcoxon (Mann-Whitney)|||||||.810
71051566|NCT03801265|141608394|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.676|||||||Wilcoxon (Mann-Whitney)|||||||.676
71051567|NCT03801265|141608395|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.908|||||||Wilcoxon (Mann-Whitney)|||||||.908
71051568|NCT03801265|141608396|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||.270
71051569|NCT03801265|141608397|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.015|||||||Wilcoxon (Mann-Whitney)|||||||.015
71051570|NCT03801265|141608398|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.203|||||||Wilcoxon (Mann-Whitney)|||||||.203
71051571|NCT03801265|141608399|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.672|||||||Wilcoxon (Mann-Whitney)|||||||.672
71051572|NCT04078126|141608400|OTHER||Mean Difference (Final Values)|-0.017|STANDARD_ERROR_OF_MEAN|0.0179||0.345|TWO_SIDED|95.0|-0.054|0.02|||ANCOVA|||||0.020|-0.054|0.3450
71051573|NCT04078126|141608401|OTHER||Mean Difference (Final Values)|-0.017|STANDARD_ERROR_OF_MEAN|0.0183||0.3675|TWO_SIDED|95.0|-0.054|0.021|||ANCOVA|||||0.021|-0.054|0.3675
71051574|NCT04078126|141608402|OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.0199||0.7563|TWO_SIDED|95.0|-0.047|0.034|||ANCOVA|||||0.034|-0.047|0.7563
71051575|NCT04078126|141608403|OTHER||Mean Difference (Final Values)|-0.032|STANDARD_ERROR_OF_MEAN|0.0521||0.5419|TWO_SIDED|95.0|-0.139|0.075|||ANCOVA|||||0.075|-0.139|0.5419
71051576|NCT04078126|141608404|OTHER||Mean Difference (Final Values)|-3.6|STANDARD_ERROR_OF_MEAN|2.334||0.1337|TWO_SIDED|95.0|-8.39|1.18|||ANCOVA|||||1.18|-8.39|0.1337
71051577|NCT04078126|141608405|OTHER||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|1.269||0.0431|TWO_SIDED|95.0|-5.29|-0.09|||ANCOVA|||||-0.09|-5.29|0.0431
71051578|NCT04078126|141608406|OTHER||Mean Difference (Final Values)|-1.53|STANDARD_ERROR_OF_MEAN|1.667||0.3625|TWO_SIDED|95.0|-4.87|1.81|||ANCOVA|||||1.81|-4.87|0.3625
70931937|NCT02307682|141364345|OTHER||Difference in proportions|-6.0|||||TWO_SIDED|95.0|-12.6|1.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||1.3|-12.6|
70931938|NCT02307682|141364345|OTHER||Difference in proportions|-5.4|||||TWO_SIDED|95.0|-12.7|1.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||1.9|-12.7|
70931939|NCT02307682|141364345|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-8.1|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||5.6|-8.1|
70931940|NCT02307682|141364345|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-6.2|7.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||7.9|-6.2|
71018349|NCT01215955|141544297|SUPERIORITY_OR_OTHER||LS Mean Difference|1.15||||0.543|TWO_SIDED|95.0|-2.55|4.84||P-value is for basal insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||4.84|-2.55|0.543
71018350|NCT01215955|141544297|SUPERIORITY_OR_OTHER||LS Mean Difference|6.72||||0.095|TWO_SIDED|95.0|-1.17|14.6||P-value is for bolus insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||14.60|-1.17|0.095
71051579|NCT04078126|141608407|OTHER||Mean Difference (Final Values)|0.043|STANDARD_ERROR_OF_MEAN|0.0198||0.0375|TWO_SIDED|95.0|0.003|0.084|||ANCOVA|||||0.084|0.003|0.0375
71018351|NCT01215955|141544297|SUPERIORITY_OR_OTHER||LS Mean Difference|8.86||||0.059|TWO_SIDED|95.0|-0.35|18.06||P-value is for total insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||18.06|-0.35|0.059
71051580|NCT04078126|141608408|OTHER||Mean Difference (Final Values)|0.005|STANDARD_ERROR_OF_MEAN|0.0443||0.9089|TWO_SIDED|95.0|-0.086|0.096|||ANCOVA|||||0.096|-0.086|0.9089
70931941|NCT02307682|141364345|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-9.6|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||3.9|-9.6|
70931942|NCT02307682|141364345|OTHER||Difference in proportions|-2.0|||||TWO_SIDED|95.0|-9.1|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||5.4|-9.1|
71018352|NCT01215955|141544297|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09||||0.497|TWO_SIDED|95.0|-2.05|4.23||P-value is for basal insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||4.23|-2.05|0.497
71018353|NCT01215955|141544297|SUPERIORITY_OR_OTHER||LS Mean Difference|5.37||||0.156|TWO_SIDED|95.0|-2.06|12.79||P-value is for bolus insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||12.79|-2.06|0.156
71018354|NCT01215955|141544297|SUPERIORITY_OR_OTHER||LS Mean Difference|6.05||||0.222|TWO_SIDED|95.0|-3.67|15.76||P-value of for total insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||15.76|-3.67|0.222
71018355|NCT01215955|141544298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.442|TWO_SIDED|95.0|-0.02|0.05||P-value is for basal insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|LS Mean Difference|||||0.05|-0.02|0.442
71051581|NCT00886288|141608453|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71051582|NCT01675661|141608459|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.985|TWO_SIDED|95.0|0.63|1.59|||Regression, Logistic|OR=1.00||For the primary outcome measure, a repeated-measures logistic regression model was used to analyze the odds of a negative urine cannabinoid test as an indicator of abstinence across all 12 weeks of treatment. A generalized estimating equations (GEEs) were used to adjust for this correlation with multiple samples per participant. The model for the primary analysis included the main effect of treatment, main effect of time, site effects, effect of smoking tobacco, and timeXtreatment interaction.||1.59|0.63|0.985
71051583|NCT01971970|141608489|EQUIVALENCE|The number of genes with a 1.5 fold change (FDR value ≤ 0.05; paired t-test) from week 0 to week 8 were assessed for pediatric IBD or adult IBD patients.|||||<|0.05|||||||Paired t-test,FDR 1.5fold,FDRvalue≤ 0.05|||The number of genes with a 1.5 fold change (FDR value ≤ 0.05; paired t-test) from week 0 to week 8 were assessed for pediatric IBD or adult IBD patients.||||< 0.05
70851169|NCT00669409|141190514|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-18.5|13.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.2|-18.5|
71051584|NCT01971970|141608490|OTHER|||||||0.2616||||||Kaplan-Meier curve comparing the percentage of children and adults on continued anti-TNF therapy over the course of study duration|gehan-breslow-wilcoxon test|||Kaplan-Meier curves were produced by dividing the population in the following groups i) paediatric versus adult patients.These groups were used to statistically compare the proportions of patients over time regarding continued anti-TNF therapy, reflecting maintenance of response at 12 and 18 months.||||0.2616
71051585|NCT01971970|141608491|OTHER|||||||0.0177||||||Kaplan-Meier curve comparing the percentage of children and adults with therapy intensification over the course of study duration|gehan-breslow-wilcoxon test|||Kaplan-Meier curves were produced by dividing the population in the following groups i) paediatric versus adult patients.These groups were used to statistically compare the proportions of patients over time regarding the escalation of anti-TNF therapy (dose increase above 5 mg/kg and/or interval shortening to less than 8 weeks)||||0.0177
71051586|NCT00655876|141608506|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.47|TWO_SIDED|95.0|0.7|1.16|||Log Rank|||The sample size was based on the primary hypothesis of a 29% reduction in the hazard rate of death with cetuximab, corresponding to an increase in 2-year overall survival (OS) from 41% to 53% and a hazard ratio (λ\[exp\]/λ\[cont\]) of 0.71 in favor of the cetuximab arm. Assuming an exponential distribution and constant hazards, 400 patients were required to reach 281 OS events, with 80% statistical power, a 1-sided α of 0.025, 4.5 years of accrual, 2 years of follow-up, and 4 interim analyses.||1.16|0.70|0.47
71051587|NCT00655876|141608507|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.65|TWO_SIDED|95.0|0.66|1.28|||Log Rank|One-sided significance level = 0.025||||1.28|0.66|0.65
71051588|NCT00655876|141608509|SUPERIORITY|||||||0.66|||||||Fisher Exact|One-sided significance level = 0.025||||||0.66
71051589|NCT00655876|141608510|SUPERIORITY|||||||0.04|||||||Chi-squared|Two-sided significance level = 0.05||6-8 weeks post-treatment||||0.04
70851170|NCT00669409|141190514|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-10.3|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-25.9|5.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.3|-25.9|
71051590|NCT00655876|141608510|SUPERIORITY|||||||0.77|||||||Chi-squared|Two-sided significance level = 0.05||1 year||||0.77
71051591|NCT00655876|141608510|SUPERIORITY|||||||0.17|||||||Chi-squared|Two-sided significance level = 0.05||2 years||||0.17
71051592|NCT01831765|141608512|NON_INFERIORITY_OR_EQUIVALENCE|The assessment was done by comparing the difference of faster aspart vs. NovoRapid®/NovoLog® in change from baseline in HbA1c after 26 weeks of randomised treatment to a non-inferiority limit of 0.4%.|Mean Difference (Net)|-0.15|||||TWO_SIDED|95.0|-0.23|-0.07||||||Change from baseline in HbA1c analysed using a mixed effect model for repeated measurements including visit 14, 18, 22, 26, 30, 34 and 36. The model included treatment, region and strata (combination of bolus adjusting method, basal treatment regimen and continuous glucose monitoring (CGM) and frequently sampled meal test subgroup) as fixed effects, subject as random effect, baseline HbA1c as covariate and interaction between all fixed effects and visit, and between the covariate and visit.||-0.07|-0.23|
71051593|NCT01831765|141608512|NON_INFERIORITY_OR_EQUIVALENCE|The assessment was done by comparing the difference of faster aspart vs. NovoRapid®/NovoLog® in change from baseline in HbA1c after 26 weeks of randomised treatment to a non-inferiority limit of 0.4%.|Mean Difference (Net)|0.04|||||TWO_SIDED|95.0|-0.04|0.12||||||Change from baseline in HbA1c analysed using a mixedeffect model for repeated measurements including visit 14, 18, 22, 26, 30, 34 and 36. The model included treatment, region and strata (combination of bolus adjusting method, basal treatment regimen and continuous glucose monitoring (CGM) and frequently sampled meal test subgroup) as fixed effects, subject as random effect, baseline HbA1c as covariate and interaction between all fixed effects and visit, and between the covariate and visit.||0.12|-0.04|
71051594|NCT02605993|141608549|OTHER||||||<|0.0001|TWO_SIDED|95.0||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|Mixed Model for Repeated Measures (MMRM)|||Statistical Analysis presented is of Cohorts 1 to 4 combined at Day 253. A sample size of 20 participants from the combined cohorts was required to provide approximately 95% power to detect a mean paired difference in LDH from Baseline of -40% at Day 253 for Cohorts 1 to 4, with an estimated standard deviation (SD) of 45%. This was based on a 2-sided paired t-test, with 5% type I error rate. To account for a possible 15% dropout rate, up to 26 participants were enrolled.||||<0.0001
71051595|NCT02605993|141608549|OTHER||||||<|0.0001|TWO_SIDED|95.0||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.|MMRM|||Statistical Analysis presented is of Cohort 4 at Day 281. A sample size of 20 participants from the combined cohorts was required to provide approximately 95% power to detect a mean paired difference in LDH from Baseline of -40% at Day 281 for Cohort 4 only, with an estimated SD of 45%. This was based on a 2-sided paired t-test, with 5% type I error rate. To account for a possible 15% dropout rate, up to 26 participants were enrolled.||||<0.0001
71051596|NCT02605993|141608550|OTHER|||||||0.0214||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|MMRM|||Statistical Analysis presented is of Cohorts 1 to 4 combined at Day 253.||||0.0214
71051597|NCT02605993|141608550|OTHER|||||||0.0313||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.|MMRM|||Statistical Analysis presented is of Cohort 4 at Day 281.||||0.0313
71051598|NCT02605993|141608551|OTHER|||||||0.0625||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|MMRM|||tatistical Analysis presented is of Cohorts 1 to 4 combined at Day 253.||||0.0625
71105509|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.708||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.708
70851171|NCT00669409|141190514|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-23.5|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-44.2|-2.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.7|-44.2|
71105510|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.106||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.106
70931943|NCT02307682|141364345|OTHER||Difference in proportions|-4.6|||||TWO_SIDED|95.0|-11.1|2.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||2.1|-11.1|
71051599|NCT02605993|141608551|OTHER|MMRM||||||0.5||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.|MMRM|||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.||||0.5000
71051600|NCT02605993|141608552|OTHER|||||||0.4871||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|MMRM|||Statistical Analysis presented is of Cohorts 1 to 4 combined at Day 253.||||0.4871
71051601|NCT02605993|141608552|OTHER|||||||0.4688||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.|MMRM|||Statistical Analysis presented is of Cohort 4 at Day 281.||||0.4688
71051602|NCT02605993|141608553|OTHER|||||||0.0023||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|MMRM|||Statistical Analysis presented is of Cohorts 1 to 4 combined at Day 253.||||0.0023
71051603|NCT02605993|141608554|OTHER|||||||0.0029||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|MMRM|||Statistical Analysis presented is of Cohorts 1 to 4 combined at Day 253.||||0.0029
71051604|NCT02605993|141608554|OTHER|||||||0.125||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.|MMRM|||Statistical Analysis presented is of Cohort 4 at Day 281.||||0.1250
71051605|NCT02603393|141608556|NON_INFERIORITY|Non-inferiority will be demonstrated if the 95% confidence interval of the treatment difference lies entirely to the right of (higher than) -50 mL.|Mean Difference (Final Values)|-0.026||||0.0404||95.0|-0.053|0.001||1 sided|Mixed Model for Repeated Measures Analys|||||0.001|-0.053|0.0404
71051606|NCT02603393|141608557|SUPERIORITY||Ratio of rates|1.08||||0.5802||95.0|0.83|1.4||2 sided|Generalized Linear Model Analysis|||||1.40|0.83|0.5802
71051607|NCT02603393|141608558|SUPERIORITY||Ratio of rates|1.08||||0.5651|TWO_SIDED|95.0|0.82|1.43||2-sided|Generalized Linear Model Analysis|||||1.43|0.82|0.5651
71051608|NCT02603393|141608559|SUPERIORITY||Ratio of rates|1.02||||0.9665|TWO_SIDED|95.0|0.44|2.34||2-sided|Generalized Linear Model Analysis|||||2.34|0.44|0.9665
71051609|NCT02603393|141608560|SUPERIORITY||Mean Difference (Final Values)|-0.026||||0.0573||95.0|-0.053|0.001||2-Sided|Mixed Model for Repeated Measures Analys|||||0.001|-0.053|0.0573
71105511|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.14||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.140
71051610|NCT02603393|141608561|SUPERIORITY||Mean Difference (Final Values)|1.8||||0.0022||95.0|0.7|3.0||2-Sided|Mixed Model for Repeated Measures Analys|||||3.0|0.7|0.0022
71051611|NCT02603393|141608562|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.0221|TWO_SIDED|95.0|0.2|2.6||2-Sided|Mixed Model for Repeated measures Analys|||||2.6|0.2|0.0221
71051612|NCT02603393|141608563|SUPERIORITY||Mean Difference (Final Values)|-0.241||||0.1724||95.0|-0.587|0.105|||Mixed Model for Repeated Measures Analys|||||0.105|-0.587|0.1724
71051613|NCT02603393|141608564|SUPERIORITY||Mean Difference (Final Values)|-0.288||||0.1055||95.0|-0.638|0.061||2-Sided|Mixed Model for Repated Measures Analysi|||||0.061|-0.638|0.1055
71051614|NCT02603393|141608565|SUPERIORITY||Mean Difference (Final Values)|0.177||||0.0641||95.0|-0.01|0.365||2-Sided|Linear Mixed Model Analysis|||||0.365|-0.010|0.0641
71051615|NCT02603393|141608566|SUPERIORITY||Mean Difference (Final Values)|0.018||||0.4107|TWO_SIDED|95.0|-0.025|0.061||2-Sided|Mixed Model for Repeated Measures Analys|||||0.061|-0.025|0.4107
71051616|NCT00759187|141608568|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Two way Anova general linear model (subject and treatment as factors)|ANOVA|||||||<0.05
71051617|NCT01974440|141608569|SUPERIORITY||Hazard Ratio (HR)|0.806||||0.0922|TWO_SIDED|95.0|0.626|1.037|||Log Rank|||||1.037|0.626|0.0922
71051618|NCT01974440|141608570|SUPERIORITY||Hazard Ratio (HR)|0.725||||0.4505|TWO_SIDED|95.0|0.312|1.682|||Log Rank|||||1.682|0.312|0.4505
71051619|NCT06354998|141608601|OTHER||Geometric Mean Ratio (GMR)|0.908|||||TWO_SIDED|95.0|0.662|1.245|||||GMR was a secondary endpoint.|GMR (mRNA-1273.815 versus licensed Spikevax) at Day 15 and its 95% CI was calculated based on the t-distribution for the mean difference of log-transformed antibody values and then back transformed to the original scale for presentation.||1.245|0.662|
71051620|NCT01948986|141608610|SUPERIORITY_OR_OTHER||Ratio (Heathy Normal/T2DM Normal)|103.07|||||TWO_SIDED|90.0|80.32|132.27|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||132.27|80.32|
71051621|NCT01948986|141608610|SUPERIORITY_OR_OTHER||Ratio (Mild Renal Impair./Pooled Norm.)|156.34|||||TWO_SIDED|90.0|127.83|191.23|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||191.23|127.83|
71051622|NCT01948986|141608610|SUPERIORITY_OR_OTHER||Ratio (Mod. Renal Impair./Pooled Norm.)|170.04|||||TWO_SIDED|90.0|139.02|207.98|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||207.98|139.02|
71051623|NCT01948986|141608610|SUPERIORITY_OR_OTHER||Ratio (Severe Renal Impair./Pooled Norm.|155.26|||||TWO_SIDED|90.0|124.38|193.8|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||193.80|124.38|
71051624|NCT01948986|141608611|SUPERIORITY_OR_OTHER||Ratio (Heathy Normal/T2DM Normal)|103.42|||||TWO_SIDED|90.0|80.66|132.61|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||132.61|80.66|
71105512|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.188||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.188
71105513|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.239||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.239
71051625|NCT01948986|141608611|SUPERIORITY_OR_OTHER||Ratio (Mild Renal Impair./Pooled Norm.)|151.63|||||TWO_SIDED|90.0|124.05|185.34|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||185.34|124.05|
71051626|NCT01948986|141608611|SUPERIORITY_OR_OTHER||Ratio (Mod. Renal Impair./Pooled Norm.)|168.11|||||TWO_SIDED|90.0|137.53|205.49|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||205.49|137.53|
71051627|NCT01948986|141608611|SUPERIORITY_OR_OTHER||Ratio (Severe Renal Impair./Pooled Norm.|151.8|||||TWO_SIDED|90.0|121.69|189.36|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||189.36|121.69|
71051628|NCT01948986|141608613|SUPERIORITY_OR_OTHER||Ratio (Heathy Normal/T2DM Normal)|101.57|||||TWO_SIDED|90.0|78.83|130.87|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||130.87|78.83|
71051629|NCT01948986|141608613|SUPERIORITY_OR_OTHER||Ratio (Mild Renal Impair./Pooled Norm.)|143.74|||||TWO_SIDED|90.0|117.15|176.37|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||176.37|117.15|
71051630|NCT01948986|141608613|SUPERIORITY_OR_OTHER||Ratio (Mod. Renal Impair./Pooled Norm.)|140.37|||||TWO_SIDED|90.0|114.4|172.23|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||172.23|114.40|
71051631|NCT01948986|141608613|SUPERIORITY_OR_OTHER||Ratio (Severe Renal Impair./Pooled Norm.|90.18|||||TWO_SIDED|90.0|71.99|112.96|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||112.96|71.99|
71051632|NCT01948986|141608620|SUPERIORITY_OR_OTHER||Ratio (Heathy Normal/T2DM Normal)|80.39|||||TWO_SIDED|90.0|59.41|108.76|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||108.76|59.41|
71051633|NCT01948986|141608620|SUPERIORITY_OR_OTHER||Ratio (Mild Renal Impair./Pooled Norm.)|53.46|||||TWO_SIDED|90.0|41.64|68.63|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||68.63|41.64|
71051634|NCT01948986|141608620|SUPERIORITY_OR_OTHER||Ratio (Mod. Renal Impair./Pooled Norm.)|43.45|||||TWO_SIDED|90.0|33.85|55.78|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||55.78|33.85|
71051635|NCT01948986|141608620|SUPERIORITY_OR_OTHER||Ratio (Severe Renal Impair./Pooled Norm.|29.02|||||TWO_SIDED|90.0|22.04|38.21|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||38.21|22.04|
71051636|NCT01948986|141608637|SUPERIORITY_OR_OTHER||Ratio: Mild Ren. Impa./T2DM Norm. Renal|76.73|||||TWO_SIDED|95.0|48.58|121.19|||||Adjusted geometrics mean values were used. The model was an ANOVA model with renal function group as a fixed effect.|||121.19|48.58|
71051637|NCT01948986|141608637|SUPERIORITY_OR_OTHER||Ratio: Mod. Ren. Impa./T2DM Norm. Renal|86.52|||||TWO_SIDED|95.0|54.78|136.65|||||Adjusted geometrics mean values were used. The model was an ANOVA model with renal function group as a fixed effect.|||136.65|54.78|
71051638|NCT01948986|141608637|SUPERIORITY_OR_OTHER||Ratio: Sev. Ren. Impa./T2DM Norm. Renal|72.74|||||TWO_SIDED|95.0|44.63|118.58|||||Adjusted geometrics mean values were used. The model was an ANOVA model with renal function group as a fixed effect.|||118.58|44.63|
71051639|NCT01948986|141608639|SUPERIORITY_OR_OTHER||Ratio (Mild Renal Impair./T2DM Norm. Ren|49.75|||||TWO_SIDED|90.0|27.22|90.93|||||The model was an ANOVA model with renal function group as a fixed effect.|||90.93|27.22|
71051640|NCT01948986|141608639|SUPERIORITY_OR_OTHER||Ratio (Mod. Renal Impair./T2DM Norm. Ren|38.1|||||TWO_SIDED|90.0|20.85|69.64|||||The model was an ANOVA model with renal function group as a fixed effect.|||69.64|20.85|
71051641|NCT01948986|141608639|SUPERIORITY_OR_OTHER||Ratio (Sev. Renal Impair./T2DM Norm. Ren|13.95|||||TWO_SIDED|90.0|7.32|26.58|||||The model was an ANOVA model with renal function group as a fixed effect.|||26.58|7.32|
71051642|NCT02283983|141608706|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71051643|NCT01898650|141608729|SUPERIORITY|||||||0.004||||||no adjustments for multiple comparisons were made. the threshold for significance was set a priori at 0.05.|t-test, 1 sided|||Null hypothesis was that blood flow would be equivalent on the unaffected and affected sides.||||0.004
71051644|NCT01791153|141608730|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|42.0|||<|0.0001|TWO_SIDED|99.5|18.0|66.0|||Cochran-Mantel-Haenszel|||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (less than or equal to \[\</=\] 30 mg/day, greater than \[\>\] 30 mg/day).||66.00|18.00|<0.0001
71051645|NCT01791153|141608730|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|39.06|||<|0.0001|TWO_SIDED|99.5|12.46|65.66|||Cochran-Mantel-Haenszel|||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||65.66|12.46|< 0.0001
71051646|NCT01791153|141608731|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||||< 0.0001
71051647|NCT01791153|141608731|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The tocilizumab group was to be considered as non-inferior to the placebo group if the lower limit of the two-sided 99.5% confidence interval was \>/= -22.5%.|Difference in Response Rates|38.35|||||TWO_SIDED|99.5|17.89|58.81||||||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||58.81|17.89|
71051648|NCT01791153|141608731|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|||||||Cochran-Mantel-Haenszel|||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||||0.0002
71051649|NCT01791153|141608731|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The tocilizumab group was to be considered as non-inferior to the placebo group if the lower limit of the two-sided 99.5% confidence interval was \>/= -22.5%.|Difference in Response Rates|35.41|||||TWO_SIDED|99.5|10.41|60.41||||||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||60.41|10.41|
71105514|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.297||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.297
70931944|NCT02307682|141364345|OTHER||Difference in proportions|-3.5|||||TWO_SIDED|95.0|-10.4|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||3.5|-10.4|
70931945|NCT02307682|141364345|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-8.0|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||5.7|-8.0|
70931946|NCT02307682|141364345|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-9.7|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.8|-9.7|
70931947|NCT02307682|141364345|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-5.5|7.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||7.9|-5.5|
70931948|NCT02307682|141364345|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-7.2|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.5|-7.2|
70931949|NCT02307682|141364345|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-5.8|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||8.4|-5.8|
70931950|NCT02307682|141364345|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-7.2|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||6.9|-7.2|
70931951|NCT02307682|141364345|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-7.9|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.5|-7.9|
71051650|NCT01791153|141608732|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.23|||<|0.0001|TWO_SIDED|99.0|0.11|0.46|||Cox proportional hazards model|||The treatment groups were compared using a Cox proportional hazards model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||0.46|0.11|<0.0001
71051651|NCT01791153|141608732|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.39||||0.0011|TWO_SIDED|99.0|0.18|0.82|||Cox proportional hazards model|||The treatment groups were compared using a Cox proportional hazards model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||0.82|0.18|0.0011
71051652|NCT01791153|141608732|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.28||||0.0001|TWO_SIDED|99.0|0.12|0.66|||Cox proportional hazards model|||The treatment groups were compared using a Cox proportional hazards model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||0.66|0.12|0.0001
70931952|NCT02307682|141364345|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-6.6|7.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||7.9|-6.6|
70931953|NCT02307682|141364345|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-9.4|5.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||5.2|-9.4|
70931954|NCT02307682|141364345|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-10.0|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||4.0|-10.0|
70931955|NCT02307682|141364345|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-6.2|8.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||8.2|-6.2|
71051653|NCT01791153|141608732|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.48||||0.0316|TWO_SIDED|99.0|0.2|1.16|||Cox proportional hazards model|||The treatment groups were compared using a Cox proportional hazards model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||1.16|0.20|0.0316
71051654|NCT01791153|141608733|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren's test|||The treatment groups were compared using a Van Elteren's test stratified by starting prednisone dose (\<=30 mg/day, \> 30 mg/day).||||<0.0001
71051655|NCT01791153|141608733|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren's test|||The treatment groups were compared using a Van Elteren's test stratified by starting prednisone dose (\<=30 mg/day, \> 30 mg/day).||||<0.0001
71051656|NCT01791153|141608733|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||Van Elteren's test|||The treatment groups were compared using a Van Elteren's test stratified by starting prednisone dose (\<=30mg/day, \>30mg/day).||||0.0003
71051657|NCT01791153|141608733|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren's test|||The treatment groups were compared using a Van Elteren's test stratified by starting prednisone dose (\<=30 mg/day, \> 30 mg/day).||||<0.0001
70851172|NCT00669409|141190515|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|11.2|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-4.6|27.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||27.0|-4.6|
71018356|NCT01215955|141544298|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07||||0.037|TWO_SIDED|95.0|0.0|0.14||P-value is for bolus insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||0.14|0.00|0.037
71018357|NCT01215955|141544298|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|||<|0.001|TWO_SIDED|95.0|0.05|0.16||P-value is for total insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||0.16|0.05|<0.001
71018358|NCT01215955|141544298|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.275|TWO_SIDED|95.0|-0.01|0.05||P-value is for basal insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|LS Mean Difference|||||0.05|-0.01|0.275
71018359|NCT01215955|141544298|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.194|TWO_SIDED|95.0|-0.02|0.08||P-value is for bolus insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||0.08|-0.02|0.194
71018360|NCT01215955|141544298|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.245|TWO_SIDED|95.0|-0.04|0.15||P-value is for total insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||0.15|-0.04|0.245
71018361|NCT01215955|141544299|SUPERIORITY_OR_OTHER|||||||0.435||95.0||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic|||||||0.435
71018362|NCT01215955|141544299|SUPERIORITY_OR_OTHER|||||||0.351||95.0||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic|||||||0.351
71018363|NCT01215955|141544300|SUPERIORITY_OR_OTHER|||||||0.802||95.0||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic|||||||0.802
71018364|NCT01215955|141544300|SUPERIORITY_OR_OTHER|||||||0.205||95.0||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic|||||||0.205
71018365|NCT01215955|141544301|SUPERIORITY_OR_OTHER||Q3D vs Q1D Ratio of Negative Binomial|1.06||||0.586|TWO_SIDED|95.0|0.86|1.3||Comparison is calculated as Q3D versus Q1D.|Negative Binomial Regression|||||1.30|0.86|0.586
71018366|NCT01215955|141544301|SUPERIORITY_OR_OTHER||Q3D vs Q1D Ratio Negative Binomial|1.05||||0.689|TWO_SIDED|95.0|0.84|1.3||Comparison is calculated as Q3D versus Q1D.|Negative Binomial|||||1.30|0.84|0.689
71018367|NCT01215955|141544302|SUPERIORITY_OR_OTHER|||||||0.258||95.0||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic|||||||0.258
71018368|NCT01215955|141544302|SUPERIORITY_OR_OTHER|||||||0.856||95.0||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic|||||||0.856
71018369|NCT00396981|141544303|NON_INFERIORITY_OR_EQUIVALENCE|This study used a non-inferiority design to demonstrate that the Matrix Coil is non-inferior to the GDC Coil, with a clinically acceptable non-inferiority margin set at 10%. Non-inferiority was used to establish the baseline estimate, which future superiority studies could be conducted. Non-inferiority was shown with a one-sided 95% CI of the difference less than the pre-specified 10% margin||||||0.76|||||||Log Rank|||Intent-to-Treat, All Subjects (N=626) GDC (N=315) Matrix (N=311) All Subjects (N=626) Subjects Who Met Primary Endpoint 35 (11.1%) 34 (10.9%) 69 (11.0%)||||0.76
71018370|NCT02494583|141544310|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.03918|TWO_SIDED|95.0|0.7|1.02||One-sided p-value based on log-rank test with stratification.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|PFS in CPS ≥1 participants of the pembro combo arm was compared to PFS in CPS ≥1 participants of the SOC arm to address the first primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and fluoropyrimidine treatment.||1.02|0.70|0.03918
71051658|NCT01791153|141608734|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|0.61||||0.8067|TWO_SIDED|99.0|-5.86|7.07|||Repeated measures model|||MCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||7.07|-5.86|0.8067
71051659|NCT01791153|141608734|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|4.44||||0.0252|TWO_SIDED|99.0|-0.69|9.56|||Repeated measures model|||MCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||9.56|-0.69|0.0252
71051660|NCT01791153|141608734|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|-0.56||||0.8374|TWO_SIDED|99.0|-7.64|6.53|||Repeated measures model|||MCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||6.53|-7.64|0.8374
71051661|NCT01791153|141608734|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|3.27||||0.1468|TWO_SIDED|99.0|-2.59|9.14|||Repeated measures model|||MCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||9.14|-2.59|0.1468
71051662|NCT01791153|141608734|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|4.38||||0.057|TWO_SIDED|99.0|-1.58|10.34|||Repeated measures model|||PCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||10.34|-1.58|0.0570
71051663|NCT01791153|141608734|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|5.59||||0.0024|TWO_SIDED|99.0|0.86|10.32|||Repeated measures model|||PCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||10.32|0.86|0.0024
71051664|NCT01791153|141608734|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|3.04||||0.2218|TWO_SIDED|99.0|-3.43|9.51|||Repeated measures model|||PCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||9.51|-3.43|0.2218
71051665|NCT01791153|141608734|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|4.25||||0.0412|TWO_SIDED|99.0|-1.14|9.64|||Repeated measures model|||PCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||9.64|-1.14|0.0412
71051666|NCT01791153|141608735|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|-15.6||||0.0312|TWO_SIDED|99.0|-34.3|3.1|||Repeated measures model|||Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||3.1|-34.3|0.0312
71051667|NCT01791153|141608735|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|-11.8||||0.0476|TWO_SIDED|99.0|-27.2|3.6|||Repeated measures model|||Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||3.6|-27.2|0.0476
71051668|NCT01791153|141608735|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|-21.9||||0.0059|TWO_SIDED|99.0|-42.4|-1.4|||Repeated measures model|||Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||-1.4|-42.4|0.0059
71051669|NCT01791153|141608735|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|-18.2||||0.0081|TWO_SIDED|99.0|-35.8|-0.5|||Repeated measures model|||Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||-0.5|-35.8|0.0081
70931956|NCT02307682|141364345|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-5.5|9.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||9.3|-5.5|
71051670|NCT00975286|141608748|SUPERIORITY_OR_OTHER||[Least squares (LS) mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.074|<|0.0001|TWO_SIDED|95.0|-0.463|-0.171||Statistical testing: 2-sided at significance level=0.05. Analysis of covariance (ANCOVA) included treatment arms; randomization strata of Week -1 HbA1c (\<8.0,\>=8.0%) and TZD use (yes/no); country as fixed effects; baseline HbA1c as covariate.|ANCOVA|||To detect a difference of 0.5% (or 0.4%) in change from baseline to Week 24 in HbA1c between lixisenatide and placebo, 225 patients in each arm would provide a power of 98% (or 90%) assuming common standard deviation of 1.3% with a 2-sided test at 5% significance level.||-0.171|-0.463|<0.0001
71051671|NCT01674647|141608764|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5|||||TWO_SIDED|95.0|0.15|1.73|||no statistical test performed||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.51% (0.20% - 1.17%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 1.02% (0.40% - 2.34%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals||1.73|0.15|
71051672|NCT01674647|141608765|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.21|2.67|||no test performed||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.61% (0.26% - 1.27%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 0.80% (0.27% - 2.00%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals||2.67|0.21|
71051673|NCT01674647|141608766|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.34|||||TWO_SIDED|95.0|0.06|2.0|||no statistical test performed||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.20% (0.04% - 0.71%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 0.61% (0.17% - 1.72%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals||2.00|0.06|
71051674|NCT01674647|141608767|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5|||||TWO_SIDED|95.0|0.16|1.55|||no statistical test performed||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.61% (0.27% - 1.29%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 1.22% (0.53% - 2.51%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals||1.55|0.16|
71051675|NCT01674647|141608772|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.18|5.47|||no statistical test performed||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.41% (0.14% - 1.02%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 0.41% (0.07% - 1.41%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals||5.47|0.18|
71051676|NCT01674647|141608773|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.2|3.49|||no statistical test performed||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.51% (0.20% - 1.17%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 0.61% (0.17% - 1.72%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals||3.49|0.20|
71051677|NCT04156620|141608792|SUPERIORITY||Marginal difference|17.91|||<|0.0001|TWO_SIDED|95.0|10.12|25.71|||Regression, Logistic|||Week 16||25.71|10.12|<0.0001
71051678|NCT04156620|141608793|SUPERIORITY||Marginal difference|20.45|||<|0.0001|TWO_SIDED|95.0|14.45|26.44|||Regression, Logistic|||||26.44|14.45|<0.0001
71051679|NCT04156620|141608794|SUPERIORITY||LS mean change|-1.01|STANDARD_ERROR_OF_MEAN|0.189|<|0.0001|TWO_SIDED|95.0|-1.38|-0.64|||Mixed Models Analysis|||Week 16||-0.64|-1.38|<0.0001
71051680|NCT04156620|141608795|SUPERIORITY||Marginal difference|22.15|||<|0.0001|TWO_SIDED|95.0|14.36|29.95|||Regression, Logistic|||||29.95|14.36|<0.0001
71051681|NCT04156620|141608796|SUPERIORITY||LS mean change|-0.94|STANDARD_ERROR_OF_MEAN|0.194|<|0.0001|TWO_SIDED|95.0|-1.33|-0.56|||Mixed Models Analysis|||Week 16||-0.56|-1.33|<0.0001
71051682|NCT04156620|141608797|SUPERIORITY||LS mean change|3.01|STANDARD_ERROR_OF_MEAN|0.615|<|0.0001|TWO_SIDED|95.0|1.8|4.22|||Mixed Models Analysis|||Week 16||4.22|1.80|<0.0001
71051683|NCT04156620|141608798|SUPERIORITY||LS mean change|-1.77|STANDARD_ERROR_OF_MEAN|0.373|<|0.0001|TWO_SIDED|95.0|-2.51|-1.04|||Mixed Models Analysis|||Week 16||-1.04|-2.51|<0.0001
71051684|NCT04156620|141608799|SUPERIORITY||Relative LS mean change|0.44|||<|0.0001|TWO_SIDED|95.0|0.37|0.51|||Mixed Models Analysis|||Week 16||0.51|0.37|<0.0001
71051685|NCT04156620|141608800|SUPERIORITY||Marginal difference|23.41|||<|0.0001|TWO_SIDED|95.0|15.61|31.66|||Regression, Logistic|||||31.66|15.61|<0.0001
71051686|NCT04156620|141608801|SUPERIORITY||Marginal difference|12.58|||<|0.0001|TWO_SIDED|95.0|7.96|17.19|||Regression, Logistic|||Week 16||17.19|7.96|<0.0001
71051687|NCT04156620|141608802|SUPERIORITY||Marginal difference|10.56|||<|0.0001|TWO_SIDED|95.0|5.64|15.47|||Regression, Logistic|||||15.47|5.64|<0.0001
71051688|NCT04156620|141608803|SUPERIORITY||LS mean change|-0.66|STANDARD_ERROR_OF_MEAN|0.292||0.0234|TWO_SIDED|95.0|-1.24|-0.09|||Regression, Logistic|||||-0.09|-1.24|0.0234
71051689|NCT02980874|141608804|SUPERIORITY||Difference in percentages|-6.1||||0.187|TWO_SIDED|95.0|-15.2|3.0||The a priori threshold for statistical significance was 0.050. Prior to evaluating the results of the CMH test, a Breslow-Day test with Tarone's adjustment was conducted to confirm the homogeneity of the odds ratios between RVO strata.|Cochran-Mantel-Haenszel|The CMH test was stratified by the type of retinal vein occlusion, i.e., branch vs. central.|Estimated value was calculated as the percentage of subjects in the Active arm meeting the primary endpoint minus the percentage of subjects in the Control arm meeting the primary endpoint.|Based on a Pearson chi-square test, a total sample size of approximately 460 subjects provided 90% power to detect a difference of 15% between the Active and Control arms assuming the Control arm showed a proportion of 0.50 at 8 weeks. The primary analysis was a test of superiority of the Active arm over the Control arm, and was based on a Cochran-Mantel-Haenszel chi-square test stratified by type of retinal vein occlusion.||3.0|-15.2|0.187
71051690|NCT01753336|141608811|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.0|STANDARD_DEVIATION|8.94|||TWO_SIDED|95.0|-9.79|-6.28||||||Cycle 1-Day 1 vs Cycle 1-Week 4. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 1 is presented.||-6.28|-9.79|
71051691|NCT01753336|141608811|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.0|STANDARD_DEVIATION|11.68|||TWO_SIDED|95.0|-7.36|-2.68||||||Cycle 1-Day 1 vs Cycle 1-Week 12. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 1 is presented.||-2.68|-7.36|
71051692|NCT01753336|141608811|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.9|STANDARD_DEVIATION|7.29|||TWO_SIDED|95.0|-7.42|-4.47||||||Cycle 2-Day 1 vs Cycle 2-Week 4. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 2 is presented.||-4.47|-7.42|
71051693|NCT01753336|141608811|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_DEVIATION|7.49|||TWO_SIDED|95.0|-3.37|-0.27||||||Cycle 2-Day 1 vs Cycle 2-Week 12. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 2 is presented.||-0.27|-3.37|
71051694|NCT01753336|141608811|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1|STANDARD_DEVIATION|9.03|||TWO_SIDED|95.0|-5.99|-2.2||||||Cycle 3-Day 1 vs Cycle 3-Week 4. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 3 was determined.||-2.20|-5.99|
71105515|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.383||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.383
70931957|NCT02307682|141364345|OTHER||Difference in proportions|2.4|||||TWO_SIDED|95.0|-5.1|9.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||9.6|-5.1|
70931958|NCT02307682|141364345|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-5.0|8.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||8.9|-5.0|
71051695|NCT01753336|141608811|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_DEVIATION|9.42|||TWO_SIDED|95.0|-3.11|0.81||||||Cycle 3-Day 1 vs Cycle 3-Week 12. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 3 was determined.||0.81|-3.11|
71051696|NCT01753336|141608812|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.5|STANDARD_DEVIATION|9.74|||TWO_SIDED|95.0|-13.38|-9.56||||||Pretreatment baseline vs Cycle 1-Week 4. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 4 visit for Treatment Cycle 1 is presented.||-9.56|-13.38|
71051697|NCT01753336|141608812|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.9|STANDARD_DEVIATION|10.89|||TWO_SIDED|95.0|-11.08|-6.71||||||Pretreatment baseline vs Cycle 1-Week 12. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 12 visit for treatment Cycle 1 is presented.||-6.71|-11.08|
71051698|NCT01753336|141608812|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.4|STANDARD_DEVIATION|11.43|||TWO_SIDED|95.0|-16.74|-12.11||||||Pretreatment baseline vs Cycle 2-Week 4. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 4 visit for Treatment Cycle 2 is presented.||-12.11|-16.74|
71051699|NCT01753336|141608812|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.6|STANDARD_DEVIATION|11.33|||TWO_SIDED|95.0|-12.92|-8.22||||||Pretreatment baseline vs Cycle 2-Week 12. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 12 visit for Treatment Cycle 2 is presented.||-8.22|-12.92|
71051700|NCT01753336|141608812|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.6|STANDARD_DEVIATION|12.19|||TWO_SIDED|95.0|-17.18|-12.1||||||Pretreatment baseline vs Cycle 3-Week 4. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 4 visit for Treatment Cycle 3 is presented.||-12.10|-17.18|
71051701|NCT01753336|141608812|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.7|STANDARD_DEVIATION|11.17|||TWO_SIDED|95.0|-14.02|-9.39||||||Pretreatment baseline vs Cycle 3-Week 12. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 12 visit for Treatment Cycle 3 is presented.||-9.39|-14.02|
71051702|NCT01753336|141608814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.5|STANDARD_DEVIATION|4.95|||TWO_SIDED|95.0|-4.46|-2.52||||||Cycle 1-Day 1 vs Cycle 1-Week 4. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 1 was determined.||-2.52|-4.46|
71105516|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.919||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.919
70931959|NCT02307682|141364345|OTHER||Difference in proportions|3.2|||||TWO_SIDED|95.0|-3.9|10.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||10.3|-3.9|
71051703|NCT01753336|141608814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_DEVIATION|5.24|||TWO_SIDED|95.0|-2.81|-0.7||||||Cycle 1-Day 1 vs Cycle 1-Week 12. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 1 was determined.||-0.70|-2.81|
71051704|NCT01753336|141608814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0|STANDARD_DEVIATION|3.77|||TWO_SIDED|95.0|-3.75|-2.23||||||Cycle 2-Day 1 vs Cycle 2-Week 4. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 2 was determined.||-2.23|-3.75|
71051705|NCT01753336|141608814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|3.86|||TWO_SIDED|95.0|-1.33|0.27||||||Cycle 2-Day 1 vs Cycle 2-Week 12. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 2 was determined.||0.27|-1.33|
71051706|NCT01753336|141608814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7|STANDARD_DEVIATION|4.32|||TWO_SIDED|95.0|-3.64|-1.83||||||Cycle 3-Day 1 vs Cycle 3-Week 4. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 3 was determined.||-1.83|-3.64|
71105517|NCT00402987|141718300|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105518|NCT00402987|141718301|SUPERIORITY_OR_OTHER_LEGACY|||||||0.537||95.0||||"Analysis at 15 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.537
70931960|NCT02307682|141364345|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-6.1|8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||8.1|-6.1|
71051707|NCT01753336|141608814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_DEVIATION|4.77|||TWO_SIDED|95.0|-2.0|-0.02||||||Cycle 3-Day 1 vs Cycle 3-Week 12. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 3 was determined.||-0.02|-2.00|
71051708|NCT01753336|141608815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9|STANDARD_DEVIATION|3.86|||TWO_SIDED|95.0|-3.64|-2.12||||||Cycle 1-Day 1 vs Cycle 1-Week 4. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 1 was determined.||-2.12|-3.64|
71051709|NCT01753336|141608815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_DEVIATION|4.82|||TWO_SIDED|95.0|-2.79|-0.86||||||Cycle 1-Day 1 vs Cycle 1-Week 12.The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 1 was determined.||-0.86|-2.79|
71051710|NCT01753336|141608815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7|STANDARD_DEVIATION|3.47|||TWO_SIDED|95.0|-2.44|-1.04||||||Cycle 2-Day 1 vs Cycle 2-Week 4. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 2 was determined.||-1.04|-2.44|
71051711|NCT01753336|141608815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|3.46|||TWO_SIDED|95.0|-1.55|-0.12||||||Cycle 2-Day 1 vs Cycle 2-Week 12. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 2 was determined.||-0.12|-1.55|
70931961|NCT02307682|141364345|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-5.1|8.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||8.9|-5.1|
70931962|NCT02307682|141364345|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-5.9|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||8.4|-5.9|
70931963|NCT02307682|141364345|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-8.5|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||5.8|-8.5|
70931964|NCT02307682|141364345|OTHER||Difference in proportions|-2.5|||||TWO_SIDED|95.0|-9.7|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||4.7|-9.7|
71051712|NCT01753336|141608815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|3.75|||TWO_SIDED|95.0|-1.45|0.12||||||Cycle 3-Day 1 vs Cycle 3-Week 4. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 3 was determined.||0.12|-1.45|
71051713|NCT01753336|141608815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_DEVIATION|3.73|||TWO_SIDED|95.0|-0.85|0.7||||||Cycle 3-Day 1 vs Cycle 3-Week 12.The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 3 was determined.||0.70|-0.85|
70931965|NCT02307682|141364345|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-7.9|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||6.5|-7.9|
70931966|NCT02307682|141364345|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-9.1|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||5.5|-9.1|
71051714|NCT01753336|141608816|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7|STANDARD_DEVIATION|3.74|||TWO_SIDED|95.0|-2.39|-0.92||||||Cycle 1-Day 1 vs Cycle 1-Week 4. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 1 was determined.||-0.92|-2.39|
71051715|NCT01753336|141608816|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4|STANDARD_DEVIATION|3.88|||TWO_SIDED|95.0|-2.22|-0.66||||||Cycle 1-Day 1 vs Cycle 1-Week 12. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 1 was determined.||-0.66|-2.22|
71051716|NCT01753336|141608816|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2|STANDARD_DEVIATION|3.12|||TWO_SIDED|95.0|-1.84|-0.58||||||Cycle 2-Day 1 vs Cycle 2-Week 4.The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 2 was determined.||-0.58|-1.84|
71051717|NCT01753336|141608816|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|3.04|||TWO_SIDED|95.0|-1.08|0.18||||||Cycle 2-Day 1 vs Cycle 2-Week 12. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 2 was determined.||0.18|-1.08|
71051718|NCT01753336|141608816|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|4.2|||TWO_SIDED|95.0|-1.57|0.19||||||Cycle 3-Day 1 vs Cycle 3-Week 4. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 3 was determined.||0.19|-1.57|
71105519|NCT00402987|141718301|SUPERIORITY_OR_OTHER_LEGACY|||||||0.697||95.0||||"Analysis at 30 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.697
71105520|NCT00402987|141718301|SUPERIORITY_OR_OTHER_LEGACY|||||||0.203||95.0||||"Analysis at 45 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.203
71105521|NCT00402987|141718301|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||"Analysis at 60 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.003
71105522|NCT00402987|141718301|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 75 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105523|NCT00402987|141718301|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 90 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105524|NCT00402987|141718301|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
70851173|NCT00669409|141190515|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.2|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-30.0|1.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.5|-30.0|
70931967|NCT02307682|141364345|OTHER||Difference in proportions|4.6|||||TWO_SIDED|95.0|-2.9|11.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||11.2|-2.9|
71105525|NCT00402987|141718301|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105526|NCT00402987|141718301|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105527|NCT00402987|141718301|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105528|NCT00402987|141718301|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105529|NCT00402987|141718301|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105530|NCT00402987|141718302|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 7 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
71105531|NCT00402987|141718302|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||"Analysis at 8 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.005
70851174|NCT00669409|141190515|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-14.3|17.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.3|-14.3|
71105532|NCT00402987|141718302|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046||95.0||||"Analysis at 9 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.046
71105533|NCT00402987|141718302|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046||95.0||||"Analysis at 10 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.046
71105534|NCT00402987|141718302|SUPERIORITY_OR_OTHER_LEGACY|||||||0.111||95.0||||"Analysis at 11 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.111
71105535|NCT00402987|141718302|SUPERIORITY_OR_OTHER_LEGACY|||||||0.226||95.0||||"Analysis at 12 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.226
71105536|NCT00402987|141718302|SUPERIORITY_OR_OTHER_LEGACY|||||||0.537||95.0||||"Analysis at 24 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.537
71105537|NCT00402987|141718303|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.64||||0.01||95.0|1.3|5.5||Treatment as a factor|Regression, Logistic|||||5.5|1.3|0.010
71105538|NCT00402987|141718303|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.07||||0.003||95.0|1.5|6.4||Treatment as a factor|Regression, Logistic|||||6.4|1.5|0.003
71105539|NCT00402987|141718303|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.634||95.0|0.6|2.2||Treatment as a factor|Regression, Logistic|||||2.2|0.6|0.634
71105540|NCT00402987|141718304|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.63||||0.202||95.0|0.8|3.5||Treatment as a factor|Regression, Logistic|||||3.5|0.8|0.202
71105541|NCT00402987|141718304|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.18||||0.077||95.0|0.9|5.1||Treatment as a factor|Regression, Logistic|||||5.1|0.9|0.077
71105542|NCT00402987|141718304|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.95||||0.134||95.0|0.8|4.7||Treatment as a factor|Regression, Logistic|||||4.7|0.8|0.134
71105543|NCT00402987|141718304|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.84||||0.671||95.0|0.4|1.9||Treatment as a factor|Regression, Logistic|||||1.9|0.4|0.671
71105544|NCT00402987|141718304|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.75||||0.484||95.0|0.3|1.7||Treatment as a factor|Regression, Logistic|||||1.7|0.3|0.484
71105545|NCT00402987|141718304|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.814||95.0|0.4|2.8||Treatment as a factor|Regression, Logistic|||||2.8|0.4|0.814
71051719|NCT01753336|141608816|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_DEVIATION|3.78|||TWO_SIDED|95.0|-0.85|0.73||||||Cycle 3-Day 1 vs Cycle 3-Week 12. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 3 was determined.||0.73|-0.85|
71051720|NCT00446199|141608819|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
71051721|NCT00446199|141608819|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
71051722|NCT00446199|141608819|SUPERIORITY_OR_OTHER|||||||0.0005||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||0.0005
71105546|NCT00402987|141718305|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to perceptible pain relief|Log Rank|||For subjects who did not experience perceptible pain relief within 2 hours post-first dose, the time to perceptible pain relief was censored at 2 hours||||<0.05
71105547|NCT00402987|141718305|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to perceptible pain relief|Log Rank|||For subjects who did not experience perceptible pain relief within 2 hours post-first dose, the time to perceptible pain relief was censored at 2 hours||||<0.05
71105548|NCT00402987|141718305|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to perceptible pain relief|Log Rank|||For subjects who did not experience perceptible pain relief within 2 hours post-first dose, the time to perceptible pain relief was censored at 2 hours||||<0.05
70931968|NCT02307682|141364345|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-6.6|8.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||8.0|-6.6|
71051723|NCT00446199|141608820|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/ van Elteren|stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
71051724|NCT00446199|141608820|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
71051725|NCT00446199|141608820|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
71105549|NCT00402987|141718306|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to meaningful pain relief|Log Rank|||For subjects who did not experience meaningful pain relief within 2 hours post-first dose, the time to meaningful pain relief was censored at 2 hours.||||<0.05
71105550|NCT00402987|141718306|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to meaningful pain relief|Log Rank|||For subjects who did not experience meaningful pain relief within 2 hours post-first dose, the time to meaningful pain relief was censored at 2 hours||||<0.05
71105551|NCT00402987|141718307|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to onset of analgesia|Log Rank|||For subjects who did not experience onset of analgesia within 2 hours post-first dose, the time to onset of analgesia was censored at 2 hours||||<0.05
71105552|NCT00402987|141718307|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to onset of analgesia|Log Rank|||For subjects who did not experience onset of analgesia within 2 hours post-first dose, the time to onset of analgesia was censored at 2 hours||||<0.05
71105553|NCT00402987|141718308|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall test of Celecoxib 50mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor).|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||<0.001
71105554|NCT00402987|141718308|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall test of Celecoxib 100mg (pooled) versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor).|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||<0.001
71051726|NCT00446199|141608821|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
71051727|NCT00446199|141608821|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
71051728|NCT00446199|141608821|SUPERIORITY_OR_OTHER|||||||0.0096||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||0.0096
71051729|NCT00446199|141608822|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|Stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
70851175|NCT00669409|141190515|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-21.9|9.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.3|-21.9|
70851176|NCT00669409|141190515|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.8|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-40.5|1.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.0|-40.5|
71051730|NCT00446199|141608822|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|Stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
71051731|NCT00446199|141608822|SUPERIORITY_OR_OTHER|||||||0.0005||95.0||||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|Stratification by center||Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||0.0005
71051732|NCT00446199|141608823|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon/van Elteren|Stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal pH is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
71051733|NCT00446199|141608823|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon/van Elteren|Stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal pH is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
71051734|NCT00446199|141608823|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon/van Elteren|Stratification by center||Comparison between E2 (0.3 mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal pH is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
71051735|NCT00446199|141608824|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal maturation value is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
71051736|NCT00446199|141608824|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon/van Elteren|Stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal maturation value is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
71051737|NCT00446199|141608824|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon/van Elteren|Stratification by center||Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal maturation value is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
71051738|NCT00446199|141608825|SUPERIORITY_OR_OTHER|||||||0.0314||95.0||||no correction for multiplicity|Cochran-Mantel-Haenszel|stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.0314
71051739|NCT00446199|141608825|SUPERIORITY_OR_OTHER|||||||0.878||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.8780
71051740|NCT00446199|141608825|SUPERIORITY_OR_OTHER|||||||0.5908||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.5908
70851177|NCT00669409|141190516|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|10.8|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-5.0|26.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||26.6|-5.0|
70851178|NCT00669409|141190516|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.2|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-30.0|1.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.6|-30.0|
71018371|NCT02494583|141544311|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.04611|TWO_SIDED|95.0|0.7|1.03||One-sided p-value based on log-rank test with stratification.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|OS in CPS ≥1 participants of the pembro combo arm was compared to OS in CPS ≥1 participants of the SOC arm to address the second primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.||1.03|0.70|0.04611
71018372|NCT02494583|141544312|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.15804|TWO_SIDED|95.0|0.62|1.17||One-sided p-value based on log-rank test with stratification.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|OS in CPS ≥10 participants of the pembro combo arm was compared to OS in CPS ≥10 participants of the SOC arm to address the third primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.||1.17|0.62|0.15804
71051741|NCT00446199|141608826|SUPERIORITY_OR_OTHER|||||||0.0027||95.0||||no correction for multiplicity|Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.0027
71051742|NCT00446199|141608826|SUPERIORITY_OR_OTHER|||||||0.4463||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.4463
70851179|NCT00669409|141190516|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-14.6|17.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.0|-14.6|
70851180|NCT00669409|141190516|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.4|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-21.0|10.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.2|-21.0|
70851181|NCT00669409|141190516|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.6|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-35.3|6.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.2|-35.3|
70851182|NCT00669409|141190517|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|10.3|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-5.5|26.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||26.1|-5.5|
70851183|NCT00669409|141190517|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.3|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-27.0|4.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.5|-27.0|
70851184|NCT00669409|141190517|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-13.3|18.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||18.3|-13.3|
70851185|NCT00669409|141190517|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-19.2|11.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.9|-19.2|
70851186|NCT00669409|141190517|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.7|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-34.4|7.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.0|-34.4|
70851187|NCT00669409|141190518|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|11.0|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-4.8|26.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||26.8|-4.8|
70851188|NCT00669409|141190518|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-8.1|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-23.9|7.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.6|-23.9|
70851189|NCT00669409|141190518|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|1.8|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-14.0|17.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.6|-14.0|
70851190|NCT00669409|141190518|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-3.6|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-19.2|12.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.0|-19.2|
70851191|NCT00669409|141190518|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-12.8|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-33.5|8.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.0|-33.5|
70851192|NCT00669409|141190519|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|11.4|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-4.4|27.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||27.2|-4.4|
70851193|NCT00669409|141190519|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-5.4|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-21.2|10.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.3|-21.2|
70851194|NCT00669409|141190519|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|4.6|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-11.2|20.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.4|-11.2|
70851195|NCT00669409|141190519|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-4.7|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-20.3|10.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.9|-20.3|
70851196|NCT00669409|141190519|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-4.1|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-24.9|16.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.6|-24.9|
70931969|NCT02307682|141364346|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-1.4|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||2.2|-1.4|
70931970|NCT02307682|141364346|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-0.5|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||4.0|-0.5|
71018373|NCT02494583|141544313|NON_INFERIORITY|Pre-specified non-inferiority margin: if the upper bound of the confidence interval (based on the alpha level allocated to the analysis) for the hazard ratio (\[HR\], pembro mono arm vs SOC) is \< 1.2, the pembro mono arm could be considered as non-inferior to the SOC arm in terms of OS.|Hazard Ratio (HR)|0.91|||||TWO_SIDED|99.2|0.69|1.18|||||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|OS in CPS ≥1 participants of the pembro mono arm was compared to OS in CPS ≥1 participants of the SOC arm to address the fourth primary hypothesis (non-inferiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.||1.18|0.69|
71018374|NCT02494583|141544313|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.16205|TWO_SIDED|95.0|0.74|1.1||One-sided p-value based on log-rank test with stratification.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|OS in CPS ≥1 participants of the pembro mono arm was compared to OS in CPS ≥1 participants of the SOC arm to address the fifth primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.||1.10|0.74|0.16205
71018375|NCT02494583|141544314|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.01491|TWO_SIDED|95.0|0.49|0.97||One-sided p-value based on log-rank test with stratification.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|OS in CPS ≥10 participants of the pembro mono arm was compared to OS in CPS ≥10 participants of the SOC arm to address the sixth primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.||0.97|0.49|0.01491
71018376|NCT02494583|141544315|OTHER||Difference in ORR Percentage|11.5||||0.00447|TWO_SIDED|95.0|2.9|20.0||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|ORR in CPS ≥1 participants of the pembro combo arm was compared to ORR in CPS ≥1 participants of the SOC arm based on Miettinen \& Nurminen method stratified by geographic region, disease status, and Fluoropyrimidine treatment.||20.0|2.9|0.00447
71018377|NCT02494583|141544317|OTHER||Difference in ORR Percentage|-22.3|||>|0.99999|TWO_SIDED|95.0|-29.6|-14.9||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|ORR in CPS ≥1 participants of the pembro mono arm was compared to ORR in CPS ≥1 participants of the SOC arm based on Miettinen \& Nurminen method stratified by geographic region, disease status, and Fluoropyrimidine treatment.||-14.9|-29.6|>0.99999
71018378|NCT02494583|141544319|OTHER||Hazard Ratio (HR)|1.64||||1|TWO_SIDED|95.0|1.36|1.98||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|PFS in CPS ≥1 participants of the pembro mono arm was compared to PFS in CPS ≥1 participants of the SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and fluoropyrimidine treatment.||1.98|1.36|1.00000
71018379|NCT02494583|141544320|OTHER||Difference in LS Means|-0.16||||0.948|TWO_SIDED|95.0|-5.01|4.69||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|cLDA||Stratified analyses could be based on collapsing strata with insufficient number of participants or events; strata were pooled in some cases based on clinical judgement and actual counts.|Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro mono arm and the SOC arm. Comparison based on constrained longitudinal data analysis (cLDA) model with GHS/QoL score as response variable and treatment by visit interaction and stratification factors (geographic region, disease status, and fluoropyrimidine treatment) as covariates.||4.69|-5.01|0.948
71018380|NCT02494583|141544321|OTHER||Difference in LS Means|1.98||||0.368|TWO_SIDED|95.0|-2.34|6.31||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|cLDA||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro combo arm and the SOC arm. Comparison based on cLDA model with GHS/QoL score as response variable and treatment by visit interaction and stratification factors (geographic region, disease status, and fluoropyrimidine treatment) as covariates.||6.31|-2.34|0.368
71051743|NCT00446199|141608826|SUPERIORITY_OR_OTHER|||||||0.0303||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.0303
71051744|NCT00446199|141608827|SUPERIORITY_OR_OTHER|||||||0.4397||95.0||||no correction for multiplicity|Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.4397
71051745|NCT00446199|141608827|SUPERIORITY_OR_OTHER|||||||0.0132||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.0132
71051746|NCT00446199|141608827|SUPERIORITY_OR_OTHER|||||||0.325||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.3250
71051747|NCT00446199|141608828|SUPERIORITY_OR_OTHER|||||||0.9555||95.0||||no correction for multiplicity|Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.9555
71051748|NCT00446199|141608828|SUPERIORITY_OR_OTHER|||||||0.1743||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.1743
71051749|NCT00446199|141608828|SUPERIORITY_OR_OTHER|||||||0.4395||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.4395
71051750|NCT00446199|141608829|SUPERIORITY_OR_OTHER|||||||0.8966||95.0||||no correction for multiplicity|Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.8966
71051751|NCT00446199|141608829|SUPERIORITY_OR_OTHER|||||||0.7512||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.7512
71051752|NCT00446199|141608829|SUPERIORITY_OR_OTHER|||||||0.8751||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.8751
71051753|NCT00446199|141608830|SUPERIORITY_OR_OTHER|||||||0.1067||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.1067
71051754|NCT00446199|141608830|SUPERIORITY_OR_OTHER|||||||0.6011||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.6011
71051755|NCT00446199|141608830|SUPERIORITY_OR_OTHER|||||||0.4408||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.4408
71051756|NCT00446199|141608831|SUPERIORITY_OR_OTHER|||||||0.0144||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.0144
71051757|NCT00446199|141608831|SUPERIORITY_OR_OTHER|||||||0.5589||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.5589
70931971|NCT02307682|141364346|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-2.6|1.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.5|-2.6|
71051758|NCT00446199|141608831|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.5500
71051759|NCT00446199|141608832|SUPERIORITY_OR_OTHER|||||||0.2179||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.2179
71051760|NCT00446199|141608832|SUPERIORITY_OR_OTHER|||||||0.7749||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.7749
71051761|NCT00446199|141608832|SUPERIORITY_OR_OTHER|||||||0.8307||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.8307
71051762|NCT00446199|141608833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.6|||<|0.0001||95.0|-33.2|-22.0||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-22.0|-33.2|<0.0001
71051763|NCT00446199|141608833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.2|||<|0.0001||95.0|-27.8|-16.6||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-16.6|-27.8|<0.0001
71051764|NCT00446199|141608833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.8||||0.0007||95.0|-15.4|-4.2||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline||-4.2|-15.4|0.0007
71051765|NCT00446199|141608834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.9|||<|0.0001||95.0|-29.9|17.8||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.||17.8|-29.9|<0.0001
71051766|NCT00446199|141608834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.2|||<|0.0001||95.0|-20.2|-8.1||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-8.1|-20.2|<0.0001
71051767|NCT00446199|141608834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6||||0.0054||95.0|-14.6|-2.5||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-2.5|-14.6|0.0054
70931972|NCT02307682|141364346|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-1.7|2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||2.9|-1.7|
70931973|NCT02307682|141364346|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-3.3|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.2|-3.3|
71051768|NCT00446199|141608835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.069|||<|0.0001||95.0|-1.28|-0.859||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-0.859|-1.280|<0.0001
71051769|NCT00446199|141608835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.803|||<|0.0001||95.0|-1.013|-0.593||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-0.593|-1.013|<0.0001
71051770|NCT00446199|141608835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.361||||0.0007||95.0|-0.57|-0.152||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-0.152|-0.570|0.0007
71051771|NCT00446199|141608836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.635|||<|0.0001||95.0|-0.813|-0.458||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|Treatment, Center, and Baseline value used as covariate||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-0.458|-0.813|<0.0001
71051772|NCT00446199|141608836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.382|||<|0.0001||95.0|-0.56|-0.205||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|Treatment, Center, and Baseline value used as covariate||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-0.205|-0.560|<0.0001
71051773|NCT00446199|141608836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.204||||0.0233||95.0|-0.381|-0.028||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|Treatment, Center, and Baseline value used as covariate||Comparison between E2 (0.3) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-0.028|-0.381|0.0233
70851197|NCT00669409|141190520|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-4.2|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-20.7|12.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.3|-20.7|
70851198|NCT00669409|141190520|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-19.3|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-35.6|-3.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.0|-35.6|
71051774|NCT03801382|141608837|EQUIVALENCE|Validity and test-retest reliability were explored|Mean Difference (Final Values)|0.05|||>|0.05|TWO_SIDED||||||t-test, 2 sided||||Validity and test-retest reliability were explored|||>.05
71051775|NCT04188301|141608846|SUPERIORITY||Odds Ratio (OR)|1.41||||0.192|TWO_SIDED|95.0|0.84|2.38||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA for living female O. volvulus worms in nodules after treatment.||2.38|0.84|0.192
71051776|NCT04188301|141608846|SUPERIORITY||Odds Ratio (OR)|1.45||||0.107|TWO_SIDED|95.0|0.92|2.29||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA3 for living female O. volvulus worms in nodules after treatment.||2.29|0.92|0.107
70931974|NCT02307682|141364346|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-3.2|2.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.7|-3.2|
70851199|NCT00669409|141190520|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-4.2|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-20.5|12.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.1|-20.5|
70851200|NCT00669409|141190520|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-15.8|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-31.9|0.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.3|-31.9|
70931975|NCT02307682|141364346|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-3.0|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||2.4|-3.0|
70931976|NCT02307682|141364346|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-2.4|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||3.1|-2.4|
71051777|NCT04188301|141608846|SUPERIORITY|IA vs IDA treatment groups for living female O. volvulus worms in nodules after treatment.|Odds Ratio (OR)|1.44||||0.068|TWO_SIDED|95.0|0.97|2.15||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||||2.15|0.97|0.068
71051778|NCT04188301|141608846|SUPERIORITY||Odds Ratio (OR)|1.03||||0.918|TWO_SIDED|95.0|0.59|1.79||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IDA vs IDA3 for living female O. volvulus worms in nodules after treatment.||1.79|0.59|0.918
71051779|NCT04188301|141608849|SUPERIORITY||Odds Ratio (OR)|1.41||||0.192|TWO_SIDED|95.0|0.84|2.38||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA for living female O. volvulus worms in nodules after treatment.||2.38|0.84|0.192
71051780|NCT04188301|141608849|SUPERIORITY||Odds Ratio (OR)|1.45||||0.107|TWO_SIDED|95.0|0.92|2.29||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA3 for living female O. volvulus worms in nodules after treatment.||2.29|0.92|0.107
71105555|NCT00402987|141718308|SUPERIORITY_OR_OTHER_LEGACY|||||||0.889||95.0||||Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg (pooled) that takes into account the ordered data (categories: excellent, good, fair, poor).|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.889
71105556|NCT00402987|141718309|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 12 hours~Overall test of Celecoxib 50mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||<0.001
71105557|NCT00402987|141718309|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 12 hours~Overall test of Celecoxib 100mg/Placebo versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.002
71105558|NCT00402987|141718309|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||95.0||||Analysis at 12 hours Overall test of Celecoxib 100mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor).|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.015
71105559|NCT00402987|141718309|SUPERIORITY_OR_OTHER_LEGACY|||||||0.411||95.0||||"Analysis at 12 hours~Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg/50mg that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.411
71105560|NCT00402987|141718309|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93||95.0||||"Analysis at 12 hours~Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg/Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.930
71105561|NCT00402987|141718309|SUPERIORITY_OR_OTHER_LEGACY|||||||0.438||95.0||||"Analysis at 12 hours~Overall test of Celecoxib 100mg/Placebo versus Celecoxib 100mg/50mg that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.438
71105562|NCT00402987|141718309|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 24 hours~Overall test of Celecoxib 50mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.002
71105563|NCT00402987|141718309|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||95.0||||"Analysis at 24 hours~Overall test of Celecoxib 100mg/Placebo versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.013
71105564|NCT00402987|141718309|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||95.0||||"Analysis at 24 hours~Overall test of Celecoxib 100mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.015
71105565|NCT00402987|141718309|SUPERIORITY_OR_OTHER_LEGACY|||||||0.748||95.0||||"Analysis at 24 hours~Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg/50mg that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.748
70931977|NCT02307682|141364346|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-2.2|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||2.4|-2.2|
71105566|NCT00402987|141718309|SUPERIORITY_OR_OTHER_LEGACY|||||||0.958||95.0||||"Analysis at 24 hours~Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg/Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.958
71105567|NCT00402987|141718309|SUPERIORITY_OR_OTHER_LEGACY|||||||0.747||95.0||||"Analysis at 24 hours~Overall test of Celecoxib 100mg/Placebo versus Celecoxib 100mg/50mg that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.747
71105568|NCT00402987|141718310|SUPERIORITY_OR_OTHER_LEGACY|||||||0.999||95.0||||"Analysis at 15 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.999
71105569|NCT00402987|141718310|SUPERIORITY_OR_OTHER_LEGACY|||||||0.609||95.0||||"Analysis at 30 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.609
71105570|NCT00402987|141718310|SUPERIORITY_OR_OTHER_LEGACY|||||||0.076||95.0||||"Analysis at 45 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.076
71105571|NCT00402987|141718310|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||"Analysis at 60 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.008
71105572|NCT00402987|141718310|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 75 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105573|NCT00402987|141718310|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 90 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105574|NCT00402987|141718310|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105575|NCT00402987|141718310|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Overall P-value"|Generalized linear model|Continuous data were analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105576|NCT00402987|141718310|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105577|NCT00402987|141718310|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105578|NCT00402987|141718310|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105579|NCT00402987|141718310|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 6 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
71105580|NCT00402987|141718311|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||"Analysis at 7 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.003
71105581|NCT00402987|141718311|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0||||"Analysis at 8 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.009
71105582|NCT00402987|141718311|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043||95.0||||"Analysis at 9 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.043
71105583|NCT00402987|141718311|SUPERIORITY_OR_OTHER_LEGACY|||||||0.032||95.0||||"Analysis at 10 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.032
71105584|NCT00402987|141718311|SUPERIORITY_OR_OTHER_LEGACY|||||||0.029||95.0||||"Analysis at 11 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.029
71105585|NCT00402987|141718311|SUPERIORITY_OR_OTHER_LEGACY|||||||0.066||95.0||||"Analysis at 12 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.066
71105586|NCT00402987|141718311|SUPERIORITY_OR_OTHER_LEGACY|||||||0.482||95.0||||"Analysis at 24 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.482
70931978|NCT02307682|141364346|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-0.3|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||5.3|-0.3|
70931979|NCT02307682|141364346|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-2.6|3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||3.2|-2.6|
70931980|NCT02307682|141364346|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-1.8|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||4.6|-1.8|
70931981|NCT02307682|141364346|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-2.9|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||3.3|-2.9|
71051781|NCT04188301|141608849|SUPERIORITY||Odds Ratio (OR)|1.44||||0.068|TWO_SIDED|95.0|0.97|2.15||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA groups for living female O. volvulus worms in nodules after treatment.||2.15|0.97|0.068
70931982|NCT02307682|141364346|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-2.3|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||4.6|-2.3|
70931983|NCT02307682|141364346|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-2.0|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.1|-2.0|
70931984|NCT02307682|141364346|OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-1.0|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||5.7|-1.0|
70931985|NCT02307682|141364346|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-1.5|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||4.4|-1.5|
71105587|NCT00402987|141718312|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3|||<|0.001||95.0|0.8|1.9||Pairwise comparison. No adjustment made for multiplicity.|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||1.9|0.8|<0.001
71105588|NCT00402987|141718312|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.002||95.0|0.4|1.5||Pairwise comparison. No adjustment made for multiplicity.|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||1.5|0.4|0.002
71105589|NCT00402987|141718312|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.186||95.0|-1.0|0.2||Pairwise comparison. No adjustment made for multiplicity.|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||0.2|-1.0|0.186
71105590|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.961||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.961
71105591|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.985||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.985
71105592|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.975||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.975
70931986|NCT02307682|141364346|OTHER||Difference in proportions|3.1|||||TWO_SIDED|95.0|0.0|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||6.5|0.0|
70931987|NCT02307682|141364346|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-2.1|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||3.9|-2.1|
70931988|NCT02307682|141364346|OTHER||Difference in proportions|2.8|||||TWO_SIDED|95.0|-0.7|6.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||6.3|-0.7|
71105593|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.532||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.532
70931989|NCT02307682|141364346|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-2.2|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.2|-2.2|
70931990|NCT02307682|141364346|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-1.4|5.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||5.2|-1.4|
71018381|NCT02494583|141544322|OTHER||Difference in LS Means|2.35||||0.308|TWO_SIDED|95.0|-2.18|6.89||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|cLDA||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|Change from baseline to Week 18 in EORTC-QLQ-STO22 Pain symptom subscale score was compared between all participants of the pembro mono arm and the SOC arm. Comparison based on cLDA model with GHS/QoL score as response variable and treatment by visit interaction and stratification factors (geographic region, disease status, and fluoropyrimidine treatment) as covariates.||6.89|-2.18|0.308
71018382|NCT02494583|141544323|OTHER||Difference in LS Means|-6.56||||0.001|TWO_SIDED|95.0|-10.55|-2.58||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|cLDA||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|Change from baseline to Week 18 in EORTC-QLQ-STO22 Pain symptom subscale score was compared between all participants of the pembro combo arm and the SOC arm. Comparison based on cLDA model with GHS/QoL score as response variable and treatment by visit interaction and stratification factors (geographic region, disease status, and fluoropyrimidine treatment) as covariates.||-2.58|-10.55|0.001
71018383|NCT02072174|141544326|SUPERIORITY|||||||0.0242|||||||Kruskal-Wallis|||||||0.0242
71018384|NCT02072174|141544327|SUPERIORITY|||||||0.0026|||||||Cochran-Mantel-Haenszel|||patient diary data||||0.0026
71018385|NCT02072174|141544327|SUPERIORITY|||||||0.0127|||||||Cochran-Mantel-Haenszel|||doctor's examination data||||0.0127
71018386|NCT02072174|141544328|SUPERIORITY|||||||0.0394||||||"The p-value associated with treatment factor of variable on day 2, 3, 4 and 5 between Anaferon for Children and Placebo. Model includes treatment, visit, treatment\*visit interaction, Day 1 covariate. Treatment\*visit interaction p-value is 0.3220."|Mixed Models Analysis|||||||0.0394
71051782|NCT04188301|141608849|SUPERIORITY||Odds Ratio (OR)|1.03||||0.918|TWO_SIDED|95.0|0.59|1.79||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IDA vs IDA3 for living female O. volvulus worms in nodules after treatment.||1.79|0.59|0.918
71018387|NCT02072174|141544328|SUPERIORITY|||||||0.322||||||"The p-value associated with treatment\*visit interaction factor of variable on day 2, 3, 4 and 5 between Anaferon for Children and Placebo. Model includes treatment, visit, treatment\*visit interaction, Day 1 covariate."|Mixed Models Analysis|||||||0.3220
71018388|NCT02072174|141544329|SUPERIORITY|||||||0.0043|||||||Cochran-Mantel-Haenszel|||||||0.0043
71018389|NCT02072174|141544330|SUPERIORITY|||||||0.0104||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 2 (patient diary data)||||0.0104
71018390|NCT02072174|141544330|SUPERIORITY|||||||0.0041||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 3 (patient diary data)||||0.0041
71018391|NCT02072174|141544330|SUPERIORITY|||||||0.0484||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 4 (patient diary data)||||0.0484
71018392|NCT02072174|141544330|SUPERIORITY|||||||0.0603||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 5 (patient diary data)||||0.0603
71018393|NCT02072174|141544330|SUPERIORITY|||||||0.0056||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 3 (doctor's examination)||||0.0056
71105594|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.690
71105595|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.82||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.820
71105596|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.180
71018394|NCT02072174|141544330|SUPERIORITY|||||||0.0994||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 5 (doctor's examination)||||0.0994
71018395|NCT02072174|141544331|SUPERIORITY|||||||0.0084|||||||Kruskal-Wallis|||Days 1-7 (patient diary data)||||0.0084
71018396|NCT02072174|141544331|SUPERIORITY|||||||0.0233|||||||Kruskal-Wallis|||Days 1, 3, 5 and 7 (doctor's examination)||||0.0233
71018397|NCT02072174|141544332|SUPERIORITY|||||||0.0721|||||||Mixed Models Analysis|||||||0.0721
71018398|NCT02072174|141544333|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||||||0.0001
71018399|NCT02072174|141544334|SUPERIORITY|||||||0.3383|||||||Fisher Exact|||||||0.3383
71018400|NCT02756078|141544343|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE score.|Posterior Mean Difference|5.0|STANDARD_DEVIATION|1.796|||TWO_SIDED|98.0|1.3|8.73|||Bayesian hierarchical model|A 98% credible interval for the posterior mean difference was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|Mean difference was calculated as Test (senofilcon A) minus Control (samfilcon A)|||8.73|1.30|
71105597|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.344||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.344
71051783|NCT04188301|141608852|SUPERIORITY||Odds Ratio (OR)|1.66||||0.134|TWO_SIDED|95.0|0.85|3.21||Adjusted p values were model-adjusted for repeated measurements per person. Participant level random effects were included in the model to adjust for multiple worms/person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA in fertile female O. volvulus worms in nodules after treatment.||3.21|0.85|0.134
71018401|NCT02756078|141544344|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE score.|Posterior Mean Difference|13.7|STANDARD_DEVIATION|1.701|||TWO_SIDED|95.0|10.34|17.05|||Bayesian hierarchical model|A 95% credible interval for the posterior mean difference was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|Mean difference was calculated as Test (senofilcon A) minus Control (samfilcon A)|||17.05|10.34|
71018402|NCT02756078|141544345|NON_INFERIORITY|A non-inferiority margin of -2 hour was used.|Posterior mean difference|-0.37|STANDARD_DEVIATION|0.313|||TWO_SIDED|95.0|-1.0|0.25|||Bayesian hierarchical model|A 95% credible interval for the posterior mean difference was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|||Mean difference was calculated as senofilcon A minus samfilcon A.|0.25|-1.00|
71018403|NCT02756078|141544346|NON_INFERIORITY|A non-inferiority margin of -2 hour was used.|Posterior mean difference|-0.06|STANDARD_DEVIATION|0.107|||TWO_SIDED|95.0|-0.27|0.16|||Bayesian hierarchical model|A 95% credible interval for the posterior mean difference was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|Mean difference was calculated as senofilcon A minus samfilcon A|||0.16|-0.27|
71018404|NCT02756078|141544347|NON_INFERIORITY|A non-inferiority margin of -2 hour was used.|Posterior mean difference|0.05|STANDARD_DEVIATION|0.261|||TWO_SIDED|95.0|-0.47|0.57|||Bayesian hierarchical model|A 95% credible interval for the posterior mean difference was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|Mean difference was calculated as senofilcon A minus samfilcon A|||0.57|-0.47|
71018405|NCT02756078|141544348|NON_INFERIORITY|A non-inferiority margin of -2 hour was used.|Posterior mean difference|-0.05|STANDARD_DEVIATION|0.159|||TWO_SIDED|95.0|-0.36|0.26|||Bayesian hierarchical model|A 95% credible interval for the posterior mean difference was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|Mean difference was calculated as senofilcon A minus samfilcon A.|||0.26|-0.36|
71018406|NCT02756078|141544349|NON_INFERIORITY|A non-inferiority margin of 0.67 was used.|Posterior odds ratio|1.35|STANDARD_DEVIATION|0.203|||TWO_SIDED|95.0|0.99|1.79|||Bayesian multinomial model|A 95% credible interval for the posterior odds ratio was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|Odds ratio was calculated as senofilcon A over samfilcon A.|||1.79|0.99|
71051784|NCT04188301|141608852|SUPERIORITY||Odds Ratio (OR)|2.23||||0.023|TWO_SIDED|95.0|1.12|4.44||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA3 for fertile female O. volvulus worms in nodules after treatment.||4.44|1.12|0.023
71105598|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.693||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.693
70931991|NCT02307682|141364346|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-3.2|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||3.9|-3.2|
71018407|NCT02180659|141544400|NON_INFERIORITY|"For the primary efficacy variable, a test of non-inferiority of Probuphine (active) versus SL BPN (control) responders was conducted. A non-inferiority margin of 20% was employed to define noninferiority.~A Confidence Interval (CI) for the difference in proportions was calculated, and non-inferiority was established if the lower bound of the 95% CI for the difference of proportions (Probuphine - SL BPN) was greater than -0.20."|Difference in Response Rate|0.088|||<|0.001|TWO_SIDED|95.0|0.009|0.167|||Chi-squared|||||0.167|0.009|<.001
71018408|NCT02180659|141544401|SUPERIORITY|At month 6 comparing those subject with no illicit drug use.||||||0.306|||||||Chi-squared|||||||0.306
71018409|NCT02180659|141544402|SUPERIORITY|||||||0.037|||||||Log Rank|||||||.037
71018410|NCT02180659|141544404|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.832|TWO_SIDED||||||ANOVA|||Comparing change in baseline to week 24 between the two groups.||||0.832
71018411|NCT02180659|141544405|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.922|TWO_SIDED||||||ANOVA|||||||0.922
71018412|NCT02180659|141544406|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.425|TWO_SIDED||||||ANOVA|||||||0.425
71105599|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.039
71018413|NCT02180659|141544407|SUPERIORITY||Median Difference (Final Values)|-1.3||||0.505|TWO_SIDED||||||ANOVA|||Comparing change in baseline to week 24 between the two groups.||||0.505
71018414|NCT03332212|141544430|OTHER||Mean Difference (Final Values)|-0.247|STANDARD_ERROR_OF_MEAN|0.164||0.1418|TWO_SIDED|95.0|-0.582|0.087|||ANOVA|||ANOVA on the PCr/ATP ratio absolute change using treatment (empagliflozin vs. placebo), history of diabetes (yes vs, no) and history of atrial fibrillation (yes vs no) as between subjects factor.||0.087|-0.582|0.1418
71018415|NCT03332212|141544430|OTHER||Mean Difference (Final Values)|-0.159|STANDARD_ERROR_OF_MEAN|0.213||0.465|TWO_SIDED|95.0|-0.604|0.286|||ANOVA|||ANOVA on the PCr/ATP ratio absolute change using treatment (empagliflozin vs. placebo), history of diabetes (yes vs, no) and history of atrial fibrillation (yes vs no) as between subjects factor.||0.286|-0.604|0.4650
71018416|NCT02058368|141544436|SUPERIORITY||Mean Difference (Final Values)|0.79||||0.069|TWO_SIDED|95.0|-0.06|1.65||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg + Tam 0.2 mg versus Placebo + Tam 0.2mg are based on t-tests from the general linear model. Reported means are model based adjusted means.|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 3.|||1.65|-0.06|0.069
70931992|NCT02307682|141364346|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-2.7|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||4.3|-2.7|
70931993|NCT02307682|141364346|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-3.3|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.0|-3.3|
70931994|NCT02307682|141364346|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-2.5|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.8|-2.5|
70931995|NCT02307682|141364346|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-2.4|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||4.6|-2.4|
70931996|NCT02307682|141364346|OTHER||Difference in proportions|2.6|||||TWO_SIDED|95.0|-1.5|6.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.3|-1.5|
70931997|NCT02307682|141364346|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-3.5|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.6|-3.5|
70931998|NCT02307682|141364346|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.9|4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||4.9|-2.9|
70931999|NCT02307682|141364346|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-2.4|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.1|-2.4|
71051785|NCT04188301|141608852|SUPERIORITY||Odds Ratio (OR)|1.32||||0.43|TWO_SIDED|95.0|0.64|2.85||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IDA1 vs IDA3 for fertile female O. volvulus worms in nodules after treatment.||2.85|.64|0.430
71051786|NCT04188301|141608852|SUPERIORITY||Odds Ratio (OR)|1.91||||0.023|TWO_SIDED|95.0|1.09|3.34||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA treatment groups for fertile female O. volvulus worms in nodules after treatment.||3.34|1.09|0.023
70932000|NCT02307682|141364346|OTHER||Difference in proportions|2.8|||||TWO_SIDED|95.0|-1.3|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||6.7|-1.3|
70932001|NCT02307682|141364346|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-3.1|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||4.5|-3.1|
70932002|NCT02307682|141364346|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-2.9|4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||4.9|-2.9|
70932003|NCT02307682|141364346|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.6|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||4.7|-2.6|
70932004|NCT02307682|141364346|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-2.7|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||5.3|-2.7|
70932005|NCT02307682|141364346|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.1|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.2|-3.1|
71051787|NCT01104779|141608853|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.0029|TWO_SIDED|95.0|-11.3|-2.4|||ANCOVA||Cariprazine 3-6 mg/day vs Placebo|||-2.4|-11.3|0.0029
71105600|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.154||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.154
71051788|NCT01104779|141608853|SUPERIORITY||Mean Difference (Final Values)|-9.9|||<|0.0001|TWO_SIDED|95.0|-14.5|-5.3|||ANCOVA||Cariprazine 6-9 mg/day vs Placebo|||-5.3|-14.5|<0.0001
71051789|NCT01104779|141608854|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.0115|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA||Cariprazine 3-6 mg/day vs Placebo|||-0.1|-0.6|0.0115
71051790|NCT01104779|141608854|SUPERIORITY||Mean Difference (Final Values)|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.3|||ANCOVA||Cariprazine 6-9 mg/day vs Placebo|||-0.3|-0.8|<0.0001
71051791|NCT05011123|141608872|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) was \>-5%|Difference in percentage of participants|-1.2|||||TWO_SIDED|95.0|-3.4|1.8|||||95% CI of the difference was calculated from the Wilson score method without continuity correction.|||1.8|-3.4|
71051792|NCT05011123|141608873|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-5%|Difference in percentage of participants|-0.9|||||TWO_SIDED|95.0|-4.0|3.0|||||95% CI of the difference was calculated from the Wilson score method without continuity correction.|||3.0|-4.0|
71051793|NCT04221789|141608885|OTHER|differences in proportions|Risk Ratio (RR)|1.12||||0.049|TWO_SIDED|95.0|1.02|1.2||Statistical significance threshold p \<0.05|Chi-squared|||Ho no difference in treatment success between groups. The study was originally powered to detect a 15% difference between groups||1.20|1.02|0.049
71051794|NCT04221789|141608886|OTHER|comparison of proportions and relative risk with 95% CI|Risk Ratio (RR)|0.7|||<|0.043|TWO_SIDED|95.0|0.5|0.97||statistical significance if p value \<0.05|Chi-squared||intervention / control|Ho No difference between arms. 80% power to detect a 10% difference||0.97|0.50|<0.043
71051795|NCT04732221|141608887|SUPERIORITY||Treatment difference|-9.2||||0.068|TWO_SIDED|95.0|-21.3|2.9||A 1-sided p-value was obtained from fitting a Robust regression estimate based on a Huber-type M estimator including terms for treatment and WHO-FC (Class II and Class III/IV) at baseline|Robust Regression|Missing data at week 12 due to death were imputed using the worst observed value and other missingness were imputed using J2R method|Least Square Mean of the overall treatment difference with 95% confidence interval (CI) was reported|||2.9|-21.3|0.068
71051796|NCT04732221|141608887|SUPERIORITY||Treatment difference|-22.0|||<|0.001|TWO_SIDED|95.0|-33.7|-10.3||based on a Huber-type M estimator including terms for treatment and WHO-FC (Class II and Class III/IV) at baseline|Robust Regression|Missing data at week 12 due to death were imputed using the worst observed value and other missingness were imputed using J2R method|Least Square Mean of the overall treatment difference with 95% confidence interval (CI) was reported|||-10.3|-33.7|<0.001
71051797|NCT04732221|141608887|SUPERIORITY||Treatment difference|-19.9||||0.002|TWO_SIDED|95.0|-33.4|-6.4||A 1-sided p-value was obtained from fitting a Robust regression estimate based on a Huber-type M estimator including terms for treatment and WHO-FC (Class II and Class III/IV) at baseline|Robust Regression|Missing data at week 12 due to death were imputed using the worst observed value and other missingness were imputed using J2R method|Least Square Mean of the overall treatment difference with 95% confidence interval (CI) was reported|||-6.4|-33.4|0.002
71051798|NCT02752906|141608937|NON_INFERIORITY|95% confidence interval (CI) of the difference was calculated from the Wilson Score Method without continuity correction. If the lower limit of the 2-sided 95% CI of the difference between the 2 percentage was \> -10%, the non- inferiority assumption was rejected.|Percentage Difference|5.0|||||TWO_SIDED|95.0|0.735|9.38||||||Serogroup A||9.38|0.735|
71051799|NCT02752906|141608937|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. If the lower limit of the 2-sided 95% CI of the difference between the 2 percentage was \> -10%, the non-inferiority assumption was rejected.|Percentage Difference|5.4|||||TWO_SIDED|95.0|2.16|8.76||||||Serogroup C||8.76|2.16|
71051800|NCT02752906|141608937|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. If the lower limit of the 2-sided 95% CI of the difference between the 2 percentage was \> -10%, the non-inferiority assumption was rejected.|Percentage Difference|1.8|||||TWO_SIDED|95.0|-0.907|4.55||||||Serogroup Y||4.55|-0.907|
71051801|NCT02752906|141608937|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. If the lower limit of the 2-sided 95% CI of the difference between the 2 percentage was \> -10%, the non-inferiority assumption was rejected.|Percentage Difference|7.4|||||TWO_SIDED|95.0|4.3|10.9||||||Serogroup W||10.9|4.30|
71051802|NCT00642694|141608957|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71051803|NCT03688282|141608966|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71105601|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.521||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.521
71051804|NCT02109419|141608972|OTHER||Pearson Test-retest reliability coeff.|0.8|||<|0.0001|TWO_SIDED||||||Pearson Test-retest reliability coeff.|||HHT-D reliability was evaluated via test-retest reliability coefficients. The dataset included participants from all groups.||||<0.0001
71051805|NCT02109419|141608972|OTHER||Pearson test-retest reliability coeff|0.87|||<|0.0001|TWO_SIDED||||||Pearson test-retest reliability coeff|||HHT-G reliability was evaluated via test-retest reliability coefficients. The dataset included participants from all groups.||||<0.0001
71051806|NCT02109419|141608972|OTHER||Pearson correlation coefficient|0.6|||<|0.0001|TWO_SIDED||||||Pearson correlation coefficient|||Validity of the HHT-D was tested by Pearson correlation coefficients between HHT-D and Geriatric Depression Scale (GDS) scores. The dataset included participants from all groups.||||<.0001
71051807|NCT02109419|141608972|OTHER||Pearson correlation coefficient|0.71||||0.0001|TWO_SIDED||||||Pearson correlation coefficient|||Validity of the HHT-G was tested by Pearson correlation coefficients between HHT-G and Mini-Mental State Examination (MMSE) scores. The dataset included participants from all groups.||||0.0001
71051808|NCT02109419|141608972|OTHER||Chronbach's alpha|0.73|||||TWO_SIDED|||||||||Internal consistency reliability of the HHT-D was assessed with Chronbach's alpha. The dataset included participants from all groups.||||
71051809|NCT02109419|141608972|OTHER||Chronbach's alpha|0.7|||||TWO_SIDED|||||||||Internal consistency reliability of the HHT-G was assessed with Chronbach's alpha. The dataset included participants from all groups.||||
71105602|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.006
71051810|NCT03560986|141608987|SUPERIORITY||Mean Difference (Net)|0.43|STANDARD_ERROR_OF_MEAN|0.372||0.2522|TWO_SIDED|95.0|-0.31|1.17||2-sided p-value for testing superiority of neridronic acid 400 mg compared to placebo.|Mixed Models Analysis|The degrees of freedom of the denominator are estimated using the Kenward-Roger approximation.|The primary endpoint estimate was the least squares mean differences of change from baseline in pain NRS (electronic diary) at Week 12 between neridronate and Placebo.|Mixed-effects model for repeated measures (MMRM) defined with baseline pain intensity as covariate, the factors geographic region, week, treatment and treatment-by-week as fixed effects, and an unstructured covariance matrix to model the covariance structure of the repeated measurements.||1.17|-0.31|0.2522
70851201|NCT00669409|141190520|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-35.1|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-56.4|-13.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-13.8|-56.4|
71051811|NCT00593736|141609002|SUPERIORITY_OR_OTHER|||||||0.646||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|Least Squares (LS) means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the analysis of covariance (ANCOVA) model.||||0.646
71051812|NCT00593736|141609002|SUPERIORITY_OR_OTHER|||||||0.084||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.084
71051813|NCT00593736|141609002|SUPERIORITY_OR_OTHER|||||||0.929||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.929
71051814|NCT00593736|141609003|SUPERIORITY_OR_OTHER|||||||0.854||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS Means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.854
71051815|NCT00593736|141609003|SUPERIORITY_OR_OTHER|||||||0.383||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS Means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.383
71051816|NCT00593736|141609003|SUPERIORITY_OR_OTHER|||||||0.883||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS Means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.883
71051817|NCT00593736|141609004|SUPERIORITY_OR_OTHER|||||||0.365||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS Means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.365
71051818|NCT00593736|141609004|SUPERIORITY_OR_OTHER|||||||0.121||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.121
71051819|NCT00593736|141609004|SUPERIORITY_OR_OTHER|||||||0.269||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.269
71051820|NCT00593736|141609005|SUPERIORITY_OR_OTHER|||||||0.92||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.920
71051821|NCT00593736|141609005|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.382
71051822|NCT00593736|141609005|SUPERIORITY_OR_OTHER|||||||0.439||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.439
71051823|NCT00593736|141609006|SUPERIORITY_OR_OTHER|||||||0.973||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.973
71051824|NCT00593736|141609006|SUPERIORITY_OR_OTHER|||||||0.117||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.117
71051825|NCT00593736|141609006|SUPERIORITY_OR_OTHER|||||||0.816||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.816
71051826|NCT00593736|141609007|SUPERIORITY_OR_OTHER|||||||0.661||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.661
71051827|NCT00593736|141609007|SUPERIORITY_OR_OTHER|||||||0.341||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.341
71105603|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.070
70932006|NCT02307682|141364346|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-2.1|6.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||6.0|-2.1|
70932007|NCT02307682|141364346|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-4.8|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||3.1|-4.8|
70932008|NCT02307682|141364346|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-4.6|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||3.9|-4.6|
70932009|NCT02307682|141364346|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-2.6|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||5.4|-2.6|
70932010|NCT02307682|141364346|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.7|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.4|-3.7|
70932011|NCT02307682|141364346|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.7|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||4.4|-3.7|
70932012|NCT02307682|141364346|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-4.1|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||4.2|-4.1|
71051828|NCT00593736|141609007|SUPERIORITY_OR_OTHER|||||||0.853||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.853
71051829|NCT00593736|141609008|SUPERIORITY_OR_OTHER|||||||0.365||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.365
70932013|NCT02307682|141364346|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-2.2|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||5.5|-2.2|
70932014|NCT02307682|141364346|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-3.0|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||5.1|-3.0|
70932015|NCT02307682|141364346|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-2.9|4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.9|-2.9|
70932016|NCT02307682|141364346|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-3.6|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.6|-3.6|
71051830|NCT00593736|141609008|SUPERIORITY_OR_OTHER|||||||0.121||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.121
71051831|NCT00593736|141609008|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.268
71051832|NCT00593736|141609009|SUPERIORITY_OR_OTHER|||||||0.9||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.900
71051833|NCT00593736|141609009|SUPERIORITY_OR_OTHER|||||||0.525||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.525
71051834|NCT00593736|141609009|SUPERIORITY_OR_OTHER|||||||0.418||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.418
71051835|NCT00593736|141609010|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.051
71051836|NCT00593736|141609010|SUPERIORITY_OR_OTHER|||||||0.926||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.926
71051837|NCT00593736|141609010|SUPERIORITY_OR_OTHER|||||||0.166||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.166
71051838|NCT00593736|141609011|SUPERIORITY_OR_OTHER|||||||0.511||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.511
71051839|NCT00593736|141609011|SUPERIORITY_OR_OTHER|||||||0.082||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.082
71051840|NCT00593736|141609011|SUPERIORITY_OR_OTHER|||||||0.188||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.188
71051841|NCT00593736|141609012|SUPERIORITY_OR_OTHER|||||||0.691||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.691
71051842|NCT00593736|141609012|SUPERIORITY_OR_OTHER|||||||0.323||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.323
71051843|NCT00593736|141609012|SUPERIORITY_OR_OTHER|||||||0.324||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.324
71051844|NCT00593736|141609013|SUPERIORITY_OR_OTHER|||||||0.197||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.197
71051845|NCT00593736|141609013|SUPERIORITY_OR_OTHER|||||||0.871||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.871
71051846|NCT00593736|141609013|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.737
71051847|NCT00593736|141609014|SUPERIORITY_OR_OTHER|||||||0.972||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.972
71051848|NCT00593736|141609014|SUPERIORITY_OR_OTHER|||||||0.117||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.117
71051849|NCT00593736|141609014|SUPERIORITY_OR_OTHER|||||||0.811||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.811
71051850|NCT00593736|141609015|SUPERIORITY_OR_OTHER|||||||0.659||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.659
71051851|NCT00593736|141609015|SUPERIORITY_OR_OTHER|||||||0.337||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.337
71051852|NCT00593736|141609015|SUPERIORITY_OR_OTHER|||||||0.853||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.853
71051853|NCT00593736|141609016|SUPERIORITY_OR_OTHER|||||||0.206||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.206
71051854|NCT00593736|141609016|SUPERIORITY_OR_OTHER|||||||0.495||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.495
71051855|NCT00593736|141609016|SUPERIORITY_OR_OTHER|||||||0.8||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.800
71051856|NCT00593736|141609017|SUPERIORITY_OR_OTHER|||||||0.194||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.194
71051857|NCT00593736|141609017|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.134
71051858|NCT00593736|141609017|SUPERIORITY_OR_OTHER|||||||0.13||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.130
71051859|NCT00593736|141609018|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.063
71051860|NCT00593736|141609018|SUPERIORITY_OR_OTHER|||||||0.156||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.156
71051861|NCT00593736|141609018|SUPERIORITY_OR_OTHER|||||||0.521||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.521
71051862|NCT00593736|141609019|SUPERIORITY_OR_OTHER|||||||0.675||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.675
71051863|NCT00593736|141609019|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.566
71051864|NCT00593736|141609019|SUPERIORITY_OR_OTHER|||||||0.205||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.205
71051865|NCT00593736|141609020|SUPERIORITY_OR_OTHER|||||||0.643||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.643
71051866|NCT00593736|141609020|SUPERIORITY_OR_OTHER|||||||0.032||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.032
71051867|NCT00593736|141609020|SUPERIORITY_OR_OTHER|||||||0.875||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.875
70851202|NCT00669409|141190521|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.7|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-21.2|11.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.8|-21.2|
70932017|NCT02307682|141364347|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-3.7|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||2.2|-3.7|
71051868|NCT00593736|141609021|SUPERIORITY_OR_OTHER|||||||0.286||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.286
71051869|NCT00593736|141609021|SUPERIORITY_OR_OTHER|||||||0.318||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.318
71051870|NCT00593736|141609021|SUPERIORITY_OR_OTHER|||||||0.483||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.483
71051871|NCT00593736|141609022|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.040
70932018|NCT02307682|141364347|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-2.6|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.4|-2.6|
70932019|NCT02307682|141364347|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-3.3|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||2.3|-3.3|
71051872|NCT00593736|141609022|SUPERIORITY_OR_OTHER|||||||0.61||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.610
71105604|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.344||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.344
70932020|NCT02307682|141364347|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-3.0|2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||2.9|-3.0|
71051873|NCT00593736|141609022|SUPERIORITY_OR_OTHER|||||||0.368||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.368
71051874|NCT00593736|141609023|SUPERIORITY_OR_OTHER|||||||0.352||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.352
71051875|NCT00593736|141609023|SUPERIORITY_OR_OTHER|||||||0.86||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.860
71051876|NCT00593736|141609023|SUPERIORITY_OR_OTHER|||||||0.297||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.297
71051877|NCT00593736|141609024|SUPERIORITY_OR_OTHER|||||||0.053||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.053
71051878|NCT00593736|141609024|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.837
71051879|NCT00593736|141609024|SUPERIORITY_OR_OTHER|||||||0.783||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.783
71051880|NCT00593736|141609025|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.566
71051881|NCT00593736|141609025|SUPERIORITY_OR_OTHER|||||||0.543||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.543
71051882|NCT00593736|141609025|SUPERIORITY_OR_OTHER|||||||0.847||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.847
71051883|NCT00593736|141609026|SUPERIORITY_OR_OTHER|||||||0.356||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.356
71105605|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
70932021|NCT02307682|141364347|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-4.6|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.4|-4.6|
71051884|NCT00593736|141609026|SUPERIORITY_OR_OTHER|||||||0.964||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.964
71051885|NCT00593736|141609026|SUPERIORITY_OR_OTHER|||||||0.799||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.799
71051886|NCT00593736|141609027|SUPERIORITY_OR_OTHER|||||||0.698||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.698
71051887|NCT00593736|141609027|SUPERIORITY_OR_OTHER|||||||0.385||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.385
71051888|NCT00593736|141609027|SUPERIORITY_OR_OTHER|||||||0.641||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.641
71051889|NCT00593736|141609028|SUPERIORITY_OR_OTHER|||||||0.979||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.979
71051890|NCT00593736|141609028|SUPERIORITY_OR_OTHER|||||||0.194||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.194
71051891|NCT00593736|141609028|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.004
71051892|NCT00593736|141609029|SUPERIORITY_OR_OTHER|||||||0.975||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.975
71051893|NCT00593736|141609029|SUPERIORITY_OR_OTHER|||||||0.639||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.639
71051894|NCT00593736|141609029|SUPERIORITY_OR_OTHER|||||||0.109||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.109
71051895|NCT00593736|141609030|SUPERIORITY_OR_OTHER|||||||0.823||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.823
71051896|NCT00593736|141609030|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.004
71051897|NCT00593736|141609030|SUPERIORITY_OR_OTHER|||||||0.296||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.296
71105606|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.022
71051898|NCT00593736|141609031|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.092
71051899|NCT00593736|141609031|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.025
71105607|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.249||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.249
71051900|NCT00593736|141609031|SUPERIORITY_OR_OTHER|||||||0.732||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.732
71051901|NCT00593736|141609032|SUPERIORITY_OR_OTHER|||||||0.298||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.298
71051902|NCT00593736|141609032|SUPERIORITY_OR_OTHER|||||||0.276||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.276
71051903|NCT00593736|141609032|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.430
71051904|NCT00593736|141609033|SUPERIORITY_OR_OTHER|||||||0.349||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.349
71105608|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105609|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.006
71105610|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.205||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.205
70851203|NCT00669409|141190521|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-33.0|-0.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-0.4|-33.0|
71051905|NCT00593736|141609033|SUPERIORITY_OR_OTHER|||||||0.203||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.203
71051906|NCT00593736|141609033|SUPERIORITY_OR_OTHER|||||||0.444||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.444
71051907|NCT00593736|141609034|SUPERIORITY_OR_OTHER|||||||0.581||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.581
71051908|NCT00593736|141609034|SUPERIORITY_OR_OTHER|||||||0.257||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.257
71051909|NCT00593736|141609034|SUPERIORITY_OR_OTHER|||||||0.688||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.688
71051910|NCT00593736|141609035|SUPERIORITY_OR_OTHER|||||||0.561||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.561
71051911|NCT00593736|141609035|SUPERIORITY_OR_OTHER|||||||0.595||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.595
71051912|NCT00593736|141609035|SUPERIORITY_OR_OTHER|||||||0.795||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.795
71105611|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71051913|NCT00593736|141609036|SUPERIORITY_OR_OTHER|||||||0.655||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.655
71051914|NCT00593736|141609036|SUPERIORITY_OR_OTHER|||||||0.177||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.177
71105612|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.002
71105613|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.186||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.186
71105614|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105615|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105616|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.179||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.179
70851204|NCT00669409|141190521|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-13.5|19.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||19.1|-13.5|
71051915|NCT00593736|141609036|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.044
71018417|NCT02058368|141544436|SUPERIORITY||Mean Difference (Final Values)|0.37||||0.43|TWO_SIDED|95.0|-0.55|1.29||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg + Tam 0.2 mg versus Placebo + Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means.|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 6.|||1.29|-0.55|0.43
71018418|NCT02058368|141544436|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.76|TWO_SIDED|95.0|-1.05|0.77||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg + Tam 0.2 mg versus Placebo + Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means.|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 9.|||0.77|-1.05|0.76
71018419|NCT02058368|141544436|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.41|TWO_SIDED|95.0|-1.27|0.53||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg + Tam 0.2 mg versus Placebo + Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 12.|||0.53|-1.27|0.41
71018420|NCT02058368|141544436|SUPERIORITY||Mean Difference (Final Values)|-0.95||||0.039|TWO_SIDED|95.0|-1.85|-0.05||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg+Tam 0.2 mg versus Placebo+ Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 15.|||-0.05|-1.85|0.039
71018421|NCT02058368|141544436|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.15|TWO_SIDED|95.0|-1.65|0.26||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg+Tam 0.2 mg versus Placebo+ Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 18.|||0.26|-1.65|0.15
71018422|NCT02058368|141544436|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.15|TWO_SIDED|95.0|-1.68|0.25||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg+Tam 0.2 mg versus Placebo+ Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 21.|||0.25|-1.68|0.15
71018423|NCT02058368|141544436|SUPERIORITY||Mean Difference (Final Values)|-1.43||||0.004|TWO_SIDED|95.0|-2.4|-0.46||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg+Tam 0.2 mg versus Placebo+ Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 24.|||-0.46|-2.40|0.004
71018424|NCT02058368|141544437|SUPERIORITY||Mean Difference (Final Values)|-23.0|STANDARD_ERROR_OF_MEAN|1.48|<|0.001|TWO_SIDED|95.0|-25.9|-20.1||Estimates are based on the adjusted means from the general linear model: Log(Post-Baseline Prostate Volume / Baseline Prostate Volume) = Log(Baseline Prostate Volume) + Treatment + Country. P-values are based on t-tests from the general linear model.|General linear model||The adjusted mean estimates, adjusted mean differences, and confidence intervals are expressed in terms of percentage change from Baseline for Month 12.|||-20.1|-25.9|<.001
71018425|NCT02058368|141544437|SUPERIORITY|Estimates are based on the adjusted means from the general linear model: Log(Post-Baseline Prostate Volume / Baseline Prostate Volume) = Log(Baseline Prostate Volume) + Treatment + Country. P-values are based on t-tests from the general linear model.|Mean Difference (Final Values)|-28.4|STANDARD_ERROR_OF_MEAN|1.65|<|0.001|TWO_SIDED|95.0|-31.7|-25.2|||General linear model||The adjusted mean estimates, adjusted mean differences, and confidence intervals are expressed in terms of percentage change from Baseline for Month 24|||-25.2|-31.7|<.001
71018426|NCT02058368|141544438|SUPERIORITY|||||||0.91||||||P-value for IPSS improvement \>= 3 units has been presented for Month 3|Mantel Haenszel|||||||0.91
71018427|NCT02058368|141544438|SUPERIORITY|||||||0.31||||||P-value for IPSS improvement \>= 2 units has been presented for Month 3|Mantel Haenszel|||||||0.31
71018428|NCT02058368|141544438|SUPERIORITY|||||||0.42||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 3|Mantel Haenszel|||||||0.42
71018429|NCT02058368|141544438|SUPERIORITY|||||||0.92||||||P-value for IPSS improvement \>= 3 units has been presented for Month 6|Mantel Haenszel|||||||0.92
71018430|NCT02058368|141544438|SUPERIORITY|||||||0.89||||||P-value for IPSS improvement \>= 2 units has been presented for Month 6|Mantel Haenszel|||||||0.89
71018431|NCT02058368|141544438|SUPERIORITY|||||||0.81||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 6|Mantel Haenszel|||||||0.81
71018432|NCT02058368|141544438|SUPERIORITY|||||||0.08||||||P-value for IPSS improvement \>= 3 units has been presented for Month 9|Mantel Haenszel|||||||0.080
71018433|NCT02058368|141544438|SUPERIORITY|||||||0.42||||||P-value for IPSS improvement \>= 2 units has been presented for Month 9|Mantel Haenszel|||||||0.42
71018434|NCT02058368|141544438|SUPERIORITY|||||||0.06||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 9|Mantel Haenszel|||||||0.060
71018435|NCT02058368|141544438|SUPERIORITY|||||||0.14||||||P-value for IPSS improvement \>= 3 units has been presented for Month 12|Mantel Haenszel|||||||0.14
71018436|NCT02058368|141544438|SUPERIORITY|||||||0.26||||||P-value for IPSS improvement \>= 2 units has been presented for Month 12|Mantel Haenszel|||||||0.26
71018437|NCT02058368|141544438|SUPERIORITY|||||||0.048||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 12|Mantel Haenszel|||||||0.048
71018438|NCT02058368|141544438|SUPERIORITY|||||||0.17||||||P-value for IPSS improvement \>= 3 units has been presented for Month 15|Mantel Haenszel|||||||0.17
71018439|NCT02058368|141544438|SUPERIORITY|||||||0.11||||||P-value for IPSS improvement \>= 2 units has been presented for Month 15|Mantel Haenszel|||||||0.11
71018440|NCT02058368|141544438|SUPERIORITY|||||||0.022||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 15|Mantel Haenszel|||||||0.022
71105617|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105618|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105619|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.259||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.259
71105620|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105621|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105622|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.393||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.393
71105623|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105624|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71018441|NCT02058368|141544438|SUPERIORITY|||||||0.18||||||P-value for IPSS improvement \>= 3 units has been presented for Month 18|Mantel Haenszel|||||||0.18
71105625|NCT00402987|141718313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.512||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.512
71105626|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105627|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105628|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.026
71105629|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.463||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.463
71105630|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.131||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.131
71105631|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.053||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.053
71105632|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105633|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105634|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.020
71105635|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.484||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.484
71105636|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.197||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.197
71018442|NCT02058368|141544438|SUPERIORITY|||||||0.19||||||P-value for IPSS improvement \>= 2 units has been presented for Month 18|Mantel Haenszel|||||||0.19
71018443|NCT02058368|141544438|SUPERIORITY|||||||0.28||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 18|Mantel Haenszel|||||||0.28
71105637|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.086||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.086
71105638|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105639|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71018444|NCT02058368|141544438|SUPERIORITY|||||||0.39||||||P-value for IPSS improvement \>= 3 units has been presented for Month 21|Mantel Haenszel|||||||0.39
71018445|NCT02058368|141544438|SUPERIORITY|||||||0.42||||||P-value for IPSS improvement \>= 2 units has been presented for Month 21|Mantel Haenszel|||||||0.42
71051916|NCT00593736|141609037|SUPERIORITY_OR_OTHER|||||||0.475||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.475
71051917|NCT00593736|141609037|SUPERIORITY_OR_OTHER|||||||0.635||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.635
71051918|NCT00593736|141609037|SUPERIORITY_OR_OTHER|||||||0.782||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.782
71051919|NCT00593736|141609038|SUPERIORITY_OR_OTHER|||||||0.192||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.192
71051920|NCT00593736|141609038|SUPERIORITY_OR_OTHER|||||||0.618||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.618
71051921|NCT00593736|141609038|SUPERIORITY_OR_OTHER|||||||0.152||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.152
71051922|NCT00593736|141609039|SUPERIORITY_OR_OTHER|||||||0.379||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.379
71051923|NCT00593736|141609039|SUPERIORITY_OR_OTHER|||||||0.057||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.057
71018446|NCT02058368|141544438|SUPERIORITY|||||||0.084||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 21|Mantel Haenszel|||||||0.084
71051924|NCT00593736|141609039|SUPERIORITY_OR_OTHER|||||||0.808||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.808
71051925|NCT00593736|141609040|SUPERIORITY_OR_OTHER|||||||0.284||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.284
71051926|NCT00593736|141609040|SUPERIORITY_OR_OTHER|||||||0.344||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.344
71018447|NCT02058368|141544438|SUPERIORITY|||||||0.016||||||P-value for IPSS improvement \>= 3 units has been presented for Month 24|Mantel Haenszel|||||||0.016
71018448|NCT02058368|141544438|SUPERIORITY|||||||0.047||||||P-value for IPSS improvement \>= 2 units has been presented for Month 24|Mantel Haenszel|||||||0.047
71051927|NCT00593736|141609040|SUPERIORITY_OR_OTHER|||||||0.558||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.558
71051928|NCT00593736|141609041|SUPERIORITY_OR_OTHER|||||||0.867||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.867
71105640|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.018
71105641|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.561||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.561
71018449|NCT02058368|141544438|SUPERIORITY|||||||0.007||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 24|Mantel Haenszel|||||||0.007
71018450|NCT02058368|141544439|SUPERIORITY||Mean Difference (Final Values)|0.91|STANDARD_ERROR_OF_MEAN|0.33||0.006|TWO_SIDED|95.0|0.26|1.56||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 6|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||1.56|0.26|0.006
71018451|NCT02058368|141544439|SUPERIORITY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.35||0.005|TWO_SIDED|95.0|0.3|1.69||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 12|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||1.69|0.30|0.005
71051929|NCT00593736|141609041|SUPERIORITY_OR_OTHER|||||||0.244||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.244
71018452|NCT02058368|141544439|SUPERIORITY||Mean Difference (Final Values)|1.46|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|0.63|2.29||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 18|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||2.29|0.63|<.001
71018453|NCT02058368|141544439|SUPERIORITY||Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|0.41||0.001|TWO_SIDED|95.0|0.54|2.15||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 24|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||2.15|0.54|0.001
71018454|NCT02058368|141544440|SUPERIORITY|||||||0.13||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 3 mL/sec for Month 6|Mantel Haenszel|||||||0.13
71018455|NCT02058368|141544440|SUPERIORITY|||||||0.15||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 30 % for Month 6|Mantel Haenszel|||||||0.15
71051930|NCT00593736|141609041|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.620
71051931|NCT00593736|141609042|SUPERIORITY_OR_OTHER|||||||0.206||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.206
71051932|NCT00593736|141609042|SUPERIORITY_OR_OTHER|||||||0.559||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.559
71051933|NCT00593736|141609042|SUPERIORITY_OR_OTHER|||||||0.074||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.074
71051934|NCT00593736|141609043|SUPERIORITY_OR_OTHER|||||||0.796||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.796
71051935|NCT00593736|141609043|SUPERIORITY_OR_OTHER|||||||0.546||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.546
71105642|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.252||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.252
71105643|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.136||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.136
71105644|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71018456|NCT02058368|141544440|SUPERIORITY||||||<|0.001||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 3 mL/sec for Month 12|Mantel Haenszel|||||||<.001
71018457|NCT02058368|141544440|SUPERIORITY|||||||0.003||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 30 % for Month 12|Mantel Haenszel|||||||0.003
71051936|NCT00593736|141609043|SUPERIORITY_OR_OTHER|||||||0.479||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.479
71051937|NCT00593736|141609044|SUPERIORITY_OR_OTHER|||||||0.766||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.766
71051938|NCT00593736|141609044|SUPERIORITY_OR_OTHER|||||||0.912||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.912
71051939|NCT00593736|141609044|SUPERIORITY_OR_OTHER|||||||0.952||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.952
71051940|NCT00593736|141609045|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.722
71105645|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71018458|NCT02058368|141544440|SUPERIORITY|||||||0.002||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 3 mL/sec for Month 18|Mantel Haenszel|||||||0.002
71018459|NCT02058368|141544440|SUPERIORITY|||||||0.009||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 30 % for Month 18|Mantel Haenszel|||||||0.009
71018460|NCT02058368|141544440|SUPERIORITY||||||<|0.001||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 3 mL/sec for Month 24|Mantel Haenszel|||||||<.001
71051941|NCT00593736|141609045|SUPERIORITY_OR_OTHER|||||||0.262||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.262
71051942|NCT00593736|141609045|SUPERIORITY_OR_OTHER|||||||0.717||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.717
71051943|NCT00593736|141609046|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.498
71051944|NCT00593736|141609046|SUPERIORITY_OR_OTHER|||||||0.664||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.664
71051945|NCT00593736|141609046|SUPERIORITY_OR_OTHER|||||||0.428||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.428
71051946|NCT00593736|141609047|SUPERIORITY_OR_OTHER|||||||0.519||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.519
71051947|NCT00593736|141609047|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.179
71051948|NCT00593736|141609047|SUPERIORITY_OR_OTHER|||||||0.935||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.935
71018461|NCT02058368|141544440|SUPERIORITY||||||<|0.001||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 30 % for Month 24|Mantel Haenszel|||||||<.001
71018462|NCT02058368|141544441|SUPERIORITY||Cox Proportional Hazard|0.27||||0.012|TWO_SIDED|95.0|0.09|0.81||Relative Risk (hazard ratio) for Dut+Tam vs. Tam is based on the Cox Proportional Hazards Model with stratification by country.|Log Rank|||||0.81|0.09|0.012
71018463|NCT02058368|141544442|SUPERIORITY||Cox Proportional Hazard|0.15||||0.005|TWO_SIDED|95.0|0.03|0.68||Relative Risk (hazard ratio) for Dut+Tam vs. Tam is based on the Cox Proportional Hazards Model with stratification by country.|Log Rank|||||0.68|0.03|0.005
71018464|NCT02058368|141544443|SUPERIORITY||Cox Proportional Hazard|0.69||||0.68|TWO_SIDED|95.0|0.11|4.11||Relative Risk (hazard ratio) for Dut+Tam vs. Tam is based on the Cox Proportional Hazards Model with stratification by country.|Log Rank|||||4.11|0.11|0.68
71051949|NCT00593736|141609048|SUPERIORITY_OR_OTHER|||||||0.425||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.425
71051950|NCT00593736|141609048|SUPERIORITY_OR_OTHER|||||||0.406||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.406
71051951|NCT00593736|141609048|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.720
71051952|NCT00593736|141609049|SUPERIORITY_OR_OTHER|||||||0.294||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.294
71051953|NCT00593736|141609049|SUPERIORITY_OR_OTHER|||||||0.474||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.474
71018465|NCT02058368|141544444|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.1||0.83|TWO_SIDED|95.0|-0.17|0.21||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value for Month 3|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.21|-0.17|0.83
71051954|NCT00593736|141609049|SUPERIORITY_OR_OTHER|||||||0.999||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.999
71018466|NCT02058368|141544444|SUPERIORITY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.1||0.11|TWO_SIDED|95.0|-0.04|0.36||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value for Month 6|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.36|-0.04|0.11
71018467|NCT02058368|141544444|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.11||0.21|TWO_SIDED|95.0|-0.07|0.34||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value for Month 9|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.34|-0.07|0.21
71018468|NCT02058368|141544444|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.1||0.8|TWO_SIDED|95.0|-0.23|0.18||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value for Month 12|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.18|-0.23|0.80
71018469|NCT02058368|141544444|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.37|TWO_SIDED|95.0|-0.3|0.11||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 15|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.11|-0.30|0.37
71018470|NCT02058368|141544444|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.11||0.44|TWO_SIDED|95.0|-0.3|0.13||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 18|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.13|-0.30|0.44
71018471|NCT02058368|141544444|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.11||0.6|TWO_SIDED|95.0|-0.16|0.28||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 21|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.28|-0.16|0.60
71018472|NCT02058368|141544444|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.11||0.16|TWO_SIDED|95.0|-0.37|0.06||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 24|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.06|-0.37|0.16
71018473|NCT02058368|141544445|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.18||0.17|TWO_SIDED|95.0|-0.11|0.62||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 3|||0.62|-0.11|0.17
71018474|NCT02058368|141544445|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.33|TWO_SIDED|95.0|-0.2|0.59||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 6|||0.59|-0.20|0.33
71051955|NCT00593736|141609050|SUPERIORITY_OR_OTHER|||||||0.655||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.655
71105646|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.018
71018475|NCT02058368|141544445|SUPERIORITY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.2||0.15|TWO_SIDED|95.0|-0.1|0.68||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 9|||0.68|-0.10|0.15
71018476|NCT02058368|141544445|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.21||0.46|TWO_SIDED|95.0|-0.25|0.55||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 12|||0.55|-0.25|0.46
71018477|NCT02058368|141544445|SUPERIORITY||Median Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.21||0.59|TWO_SIDED|95.0|-0.51|0.29||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 15|||0.29|-0.51|0.59
71051956|NCT00593736|141609050|SUPERIORITY_OR_OTHER|||||||0.331||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.331
71105647|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.653||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.653
71105648|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.287||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.287
71105649|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.191||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.191
71105650|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
70851205|NCT00669409|141190521|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.1|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-29.2|3.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.0|-29.2|
71018478|NCT02058368|141544445|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.2||0.56|TWO_SIDED|95.0|-0.52|0.28||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 18|||0.28|-0.52|0.56
71018479|NCT02058368|141544445|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.21||0.51|TWO_SIDED|95.0|-0.56|0.28||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 21|||0.28|-0.56|0.51
71051957|NCT00593736|141609050|SUPERIORITY_OR_OTHER|||||||0.362||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.362
71051958|NCT00593736|141609051|SUPERIORITY_OR_OTHER|||||||0.684||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.684
71051959|NCT00593736|141609051|SUPERIORITY_OR_OTHER|||||||0.399||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.399
71051960|NCT00593736|141609051|SUPERIORITY_OR_OTHER|||||||0.611||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.611
71051961|NCT00593736|141609052|SUPERIORITY_OR_OTHER|||||||0.157||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.157
71051962|NCT00593736|141609052|SUPERIORITY_OR_OTHER|||||||0.463||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.463
71051963|NCT00593736|141609052|SUPERIORITY_OR_OTHER|||||||0.774||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.774
71051964|NCT00593736|141609053|SUPERIORITY_OR_OTHER|||||||0.413||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.413
71018480|NCT02058368|141544445|SUPERIORITY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.21||0.034|TWO_SIDED|95.0|-0.88|-0.03||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 24|||-0.03|-0.88|0.034
71051965|NCT00593736|141609053|SUPERIORITY_OR_OTHER|||||||0.093||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.093
71051966|NCT00593736|141609053|SUPERIORITY_OR_OTHER|||||||0.982||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.982
71105651|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
70851206|NCT00669409|141190521|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.5|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-32.8|9.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.7|-32.8|
71051967|NCT00593736|141609054|SUPERIORITY_OR_OTHER|||||||0.441||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.441
71051968|NCT00593736|141609054|SUPERIORITY_OR_OTHER|||||||0.082||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.082
71051969|NCT00593736|141609054|SUPERIORITY_OR_OTHER|||||||0.549||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.549
71051970|NCT00593736|141609055|SUPERIORITY_OR_OTHER|||||||0.86||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.860
71051971|NCT00593736|141609055|SUPERIORITY_OR_OTHER|||||||0.997||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.997
71018481|NCT02058368|141544446|SUPERIORITY||Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.54|-0.5||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value.P-values for Dut+Tam versus Tam are based on t-tests from the general linear model for Month 12|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam.|||-0.50|-1.54|<.001
71105652|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.018
71105653|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.741||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.741
71105654|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.326||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.326
71105655|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.256||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.256
70851207|NCT00669409|141190522|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-22.9|10.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.1|-22.9|
70851208|NCT00669409|141190522|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.4|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-35.7|-3.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.1|-35.7|
70851209|NCT00669409|141190522|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-15.0|17.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.6|-15.0|
70851210|NCT00669409|141190522|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-27.1|5.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.1|-27.1|
70851211|NCT00669409|141190522|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-26.0|16.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.5|-26.0|
70851212|NCT00669409|141190523|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-21.1|11.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.9|-21.1|
70851213|NCT00669409|141190523|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.6|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-35.9|-3.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.3|-35.9|
70851214|NCT00669409|141190523|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-20.4|12.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.2|-20.4|
70851215|NCT00669409|141190523|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.8|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-30.0|2.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.3|-30.0|
71018482|NCT02058368|141544446|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.27||0.009|TWO_SIDED|95.0|-1.23|-0.18||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model for Month 24|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam.|||-0.18|-1.23|0.009
71018483|NCT02058368|141544451|SUPERIORITY||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-2.1|-1.6||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Baseline Value for Month 6|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam.|||-1.6|-2.1|<.001
71018484|NCT02058368|141544451|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-2.3|-1.9||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Baseline Value for Month 12|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam.|||-1.9|-2.3|<.001
71105656|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105657|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
70932022|NCT02307682|141364347|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-3.5|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||3.6|-3.5|
70932023|NCT02307682|141364347|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-4.2|2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||2.9|-4.2|
71051972|NCT00593736|141609055|SUPERIORITY_OR_OTHER|||||||0.834||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.834
71051973|NCT00593736|141609056|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.837
71051974|NCT00593736|141609056|SUPERIORITY_OR_OTHER|||||||0.321||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.321
71051975|NCT00593736|141609056|SUPERIORITY_OR_OTHER|||||||0.978||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.978
71051976|NCT00593736|141609057|SUPERIORITY_OR_OTHER|||||||0.513||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.513
71051977|NCT00593736|141609057|SUPERIORITY_OR_OTHER|||||||0.751||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.751
71051978|NCT00593736|141609057|SUPERIORITY_OR_OTHER|||||||0.242||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.242
71051979|NCT00593736|141609058|SUPERIORITY_OR_OTHER|||||||0.307||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.307
71051980|NCT00593736|141609058|SUPERIORITY_OR_OTHER|||||||0.765||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.765
71051981|NCT00593736|141609058|SUPERIORITY_OR_OTHER|||||||0.727||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.727
71051982|NCT00593736|141609059|SUPERIORITY_OR_OTHER|||||||0.902||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.902
71051983|NCT00593736|141609059|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.590
71051984|NCT00593736|141609059|SUPERIORITY_OR_OTHER|||||||0.29||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.290
71051985|NCT00593736|141609060|SUPERIORITY_OR_OTHER|||||||0.685||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.685
71051986|NCT00593736|141609060|SUPERIORITY_OR_OTHER|||||||0.214||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.214
71051987|NCT00593736|141609060|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.055
71051988|NCT00593736|141609061|SUPERIORITY_OR_OTHER|||||||0.589||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.589
71051989|NCT00593736|141609061|SUPERIORITY_OR_OTHER|||||||0.156||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.156
71051990|NCT00593736|141609061|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.041
71051991|NCT01783548|141609066|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.66||||0.002|TWO_SIDED|95.0|-1.08|-0.24||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||Based on other studies, the standard deviation for the change from baseline over the first 6 weeks of treatment in the average of AM and PM rTNSS is assumed to be 2.0. Using this standard deviation, 450 subjects aged 6 to 11 years (300 on active treatment of BDP and 150 on placebo) provide approximately 90% power to detect a difference of 0.65 in rTNSS change from baseline between treatment groups with a two-sided alpha level of 0.05.||-0.24|-1.08|0.002
71051992|NCT01783548|141609067|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.58||||0.004|TWO_SIDED|95.0|-0.99|-0.18||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.18|-0.99|0.004
71051993|NCT01783548|141609068|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.62||||0.002|TWO_SIDED|95.0|-1.0|-0.23||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.23|-1.00|0.002
71051994|NCT01783548|141609069|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.54||||0.004|TWO_SIDED|95.0|-0.91|-0.17||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.17|-0.91|0.004
71051995|NCT03493386|141609070|EQUIVALENCE|If the 90% CI of the ratio of geometric mean doesn't fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geometric mean|1.02|||||TWO_SIDED|90.0|0.97|1.07|||||AUC (0-t)|||1.07|0.97|
71051996|NCT03493386|141609070|EQUIVALENCE|If the 90% CI of the ratio of geometric mean doesn't fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geometric mean|1.02|||||TWO_SIDED|90.0|0.97|1.07|||||AUC(0-inf)|||1.07|0.97|
71051997|NCT03493386|141609071|EQUIVALENCE|If the 90% CI of the ratio of geometric mean doesn't fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geometric mean|1.04|||||TWO_SIDED|90.0|0.97|1.12|||||Cmax|||1.12|0.97|
71051998|NCT03493386|141609078|EQUIVALENCE|If the 90% CI of the ratio of geometric mean doesn't fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geometric mean|0.91|||||TWO_SIDED|90.0|0.82|1.01|||||AUC (0-t)|||1.01|0.82|
71051999|NCT03493386|141609078|EQUIVALENCE|If the 90% CI of the ratio of geometric mean doesn't fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geometric mean|0.91|||||TWO_SIDED|90.0|0.82|1.01|||||AUC (0-inf)|||1.01|0.82|
71052000|NCT03493386|141609079|EQUIVALENCE|If the 90% CI of the ratio of geometric mean doesn't fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geomtric mean|0.89||||||90.0|0.73|1.08||||||||1.08|0.73|
71052001|NCT00988442|141609126|SUPERIORITY_OR_OTHER|||||||1||||||Two-sided 5% significance level.|Fisher Exact|||A Fisher's exact test was used to compare the proportion of participants with virologic suppression, defined as HIV-1 RNA less than 200 copies/mL at week 48 between the standard of care and standard of care + enhanced telephone support groups.||||1.000
71105658|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.016||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.016
71105659|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.808||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.808
71052002|NCT00117325|141609180|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.335||||0.05|TWO_SIDED|95.0|-0.67|0.0|||ANCOVA|Analysis of covariance (ANCOVA) method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.||0.00|-0.67|0.050
71105660|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.394||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.394
71105661|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.343||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.343
71105662|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.005
71105663|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.029||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.029
71105664|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.023
71052003|NCT00117325|141609181|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.393||||0.027|TWO_SIDED|95.0|-0.74|-0.05||Week 1-4|ANCOVA|ANCOVA method was used adjusting for baseline iTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.||-0.05|-0.74|0.027
71052004|NCT00117325|141609182|SUPERIORITY_OR_OTHER|||||||0.184|||||||Regression, Logistic|logistic regression adjusting for age, gender, investigator, and treatment.||Placebo versus Fluticasone Furoate 110 mcg QD up to Week 4 analysis.|Effectiveness of study medication for relieving non-allergic rhinitis symptoms over the entire treatment period (Total response) was analyzed.|||0.184
71052005|NCT00117325|141609183|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.348||||0.051|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.||0.00|-0.70|0.051
71052006|NCT00117325|141609184|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.304||||0.076|TWO_SIDED|95.0|-0.64|0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD up to Week 4 analysis||0.03|-0.64|0.076
71105665|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.892||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.892
71105666|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.952||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.952
70851216|NCT00669409|141190523|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-27.5|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-48.8|-6.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-6.2|-48.8|
71105667|NCT00402987|141718314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.948||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.948
71105668|NCT00402987|141718315|SUPERIORITY_OR_OTHER_LEGACY|||||||0.775||95.0||||"Analysis at 15 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.775
71052007|NCT00117325|141609185|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.51||||0.093|TWO_SIDED|95.0|-9.77|0.75|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.||0.75|-9.77|0.093
71052008|NCT00117325|141609186|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.372||||0.023|TWO_SIDED|95.0|-11.8|-0.9|||ANCOVA|ANCOVA method was used adjusting for baseline iTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.||-0.90|-11.8|0.023
71105669|NCT00402987|141718315|SUPERIORITY_OR_OTHER_LEGACY|||||||0.094||95.0||||"Analysis at 30 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.094
71105670|NCT00402987|141718315|SUPERIORITY_OR_OTHER_LEGACY|||||||0.114||95.0||||"Analysis at 45 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.114
71105671|NCT00402987|141718315|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||"Analysis at 60 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.005
71105672|NCT00402987|141718315|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 75 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105673|NCT00402987|141718315|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 90 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71052009|NCT00117325|141609187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.118||||0.061|TWO_SIDED|95.0|-0.24|0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for Rhinorrhea||0.01|-0.24|0.061
71052010|NCT00117325|141609187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.124||||0.061|TWO_SIDED|95.0|-0.25|0.01|||ANCOVA|||Placebo versus Fluticasone Furoate 110 mcg QD for Nasal Congestion||0.01|-0.25|0.061
71052011|NCT00117325|141609187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.095||||0.138|TWO_SIDED|95.0|-0.22|0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for post-nasal drip||0.03|-0.22|0.138
71105674|NCT00402987|141718315|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105675|NCT00402987|141718315|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105676|NCT00402987|141718315|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105677|NCT00402987|141718315|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105678|NCT00402987|141718315|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105679|NCT00402987|141718315|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 6 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
71105680|NCT00402987|141718316|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 7 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
71105681|NCT00402987|141718316|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 8 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.002
71105682|NCT00402987|141718316|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0||||"Analysis at 9 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.007
71105683|NCT00402987|141718316|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||95.0||||"Analysis at 10 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.015
71105684|NCT00402987|141718316|SUPERIORITY_OR_OTHER_LEGACY|||||||0.033||95.0||||"Analysis at 11 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.033
71105685|NCT00402987|141718316|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036||95.0||||"Analysis at 12 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.036
71052012|NCT00117325|141609188|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.113||||0.087|TWO_SIDED|95.0|-0.24|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for Rhinorrhea||0.02|-0.24|0.087
71052013|NCT00117325|141609188|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.164||||0.015|TWO_SIDED|95.0|-0.3|-0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for nasal congestion||-0.03|-0.30|0.015
71052014|NCT00117325|141609188|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.112||||0.106|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for post-nasal drip||0.02|-0.25|0.106
70851217|NCT00669409|141190524|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-19.6|13.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.4|-19.6|
71052015|NCT00117325|141609189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.132||||0.048|TWO_SIDED|95.0|-0.26|0.0|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rhinorrhea||-0.00|-0.26|0.048
71052016|NCT00117325|141609189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.124||||0.076|TWO_SIDED|95.0|-0.26|0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for Nasal congestion||0.01|-0.26|0.076
71052017|NCT00117325|141609189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.093||||0.164|TWO_SIDED|95.0|-0.22|0.04|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg for post-nasal drip||0.04|-0.22|0.164
71052018|NCT00117325|141609190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.096||||0.136|TWO_SIDED|95.0|-0.22|0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for Rhinorrhea||0.03|-0.22|0.136
70851218|NCT00669409|141190524|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.5|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-35.8|-3.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.1|-35.8|
70851219|NCT00669409|141190524|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.1|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-25.4|7.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.2|-25.4|
70851220|NCT00669409|141190524|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.6|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-32.8|-0.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-0.5|-32.8|
70851221|NCT00669409|141190524|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-32.6|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-53.9|-11.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-11.4|-53.9|
70851222|NCT00669409|141190525|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-20.1|12.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.9|-20.1|
70851223|NCT00669409|141190525|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-21.5|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-37.9|-5.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-5.2|-37.9|
71052019|NCT00117325|141609190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.111||||0.1||95.0|-0.24|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for nasal congestion||0.02|-0.24|0.100
71052020|NCT00117325|141609190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.111||||0.1|TWO_SIDED|95.0|-0.24|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for post-nasal drip||0.02|-0.24|0.100
71052021|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.45||||0.011|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 1||-0.10|-0.80|0.011
71052022|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.325||||0.089|TWO_SIDED|95.0|-0.7|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 2||0.05|-0.70|0.089
71052023|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.393||||0.052|TWO_SIDED|95.0|-0.79|0.0|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 3||0.00|-0.79|0.052
70932024|NCT02307682|141364347|OTHER||Difference in proportions|-1.5|||||TWO_SIDED|95.0|-5.0|2.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||2.0|-5.0|
70932025|NCT02307682|141364347|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-4.1|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||2.4|-4.1|
70932026|NCT02307682|141364347|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-2.3|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||4.7|-2.3|
70932027|NCT02307682|141364347|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-3.9|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||3.1|-3.9|
70932028|NCT02307682|141364347|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-1.8|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||6.2|-1.8|
70932029|NCT02307682|141364347|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-3.5|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||4.7|-3.5|
71052024|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.262||||0.187|TWO_SIDED|95.0|-0.65|0.13|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 4||0.13|-0.65|0.187
71052025|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.298||||0.164|TWO_SIDED|95.0|-0.72|0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 5||0.12|-0.72|0.164
71052026|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.573||||0.008|TWO_SIDED|95.0|-1.0|-0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 6||-0.15|-1.00|0.008
70932030|NCT02307682|141364347|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.6|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||4.4|-3.6|
71052027|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.376||||0.082|TWO_SIDED|95.0|-0.8|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 7||0.05|-0.80|0.082
71052028|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.231||||0.296|TWO_SIDED|95.0|-0.67|0.2|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 8||0.20|-0.67|0.296
71105686|NCT00402987|141718316|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0||||"Analysis at 24 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.500
70932031|NCT02307682|141364347|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.2|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.6|-3.2|
70932032|NCT02307682|141364347|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.2|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.5|-3.2|
71052029|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.191||||0.383|TWO_SIDED|95.0|-0.62|0.24|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 9||0.24|-0.62|0.383
71052030|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.464||||0.048|TWO_SIDED|95.0|-0.92|0.0|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 10||-0.00|-0.92|0.048
71052031|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.172||||0.469|TWO_SIDED|95.0|-0.64|0.29|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 11||0.29|-0.64|0.469
71052032|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34||||0.151|TWO_SIDED|95.0|-0.8|0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 12||0.12|-0.80|0.151
71052033|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.344||||0.145|TWO_SIDED|95.0|-0.81|0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 13||0.12|-0.81|0.145
71105687|NCT00402987|141718317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|16.2|||<|0.001||95.0|8.5|23.8||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||23.8|8.5|<0.001
71018485|NCT02058368|141544451|SUPERIORITY||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-3.1|-2.2||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Baseline Value for Month 24|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam.|||-2.2|-3.1|<.001
71105688|NCT00402987|141718317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.2||||0.009||95.0|2.6|17.9||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||17.9|2.6|0.009
71018486|NCT02058368|141544453|SUPERIORITY|||||||0.77||||||P-value for Dut+Tam vs. Tam is based on a van Elteren test with stratification by country for Month 6|Van Elteren test|||||||0.77
71018487|NCT02058368|141544453|SUPERIORITY|||||||0.84||||||P-value for Dut+Tam vs. Tam is based on a van Elteren test with stratification by country for Month 12|Van Elteren test|||||||0.84
71018488|NCT02058368|141544453|SUPERIORITY|||||||0.98||||||P-value for Dut+Tam vs. Tam is based on a van Elteren test with stratification by country for Month 18|Van Elteren test|||||||0.98
71018489|NCT02058368|141544453|SUPERIORITY|||||||0.28||||||P-value for Dut+Tam vs. Tam is based on a van Elteren test with stratification by country for Month 24|Van Elteren test|||||||0.28
71018490|NCT01652872|141544460|OTHER||Treatment Difference|-0.27|||||TWO_SIDED|95.0|-6.39|5.85|||||Difference is fixed dose - titration.|||5.85|-6.39|
71018491|NCT01652872|141544460|OTHER||Risk Ratio (RR)|0.998|||||TWO_SIDED|95.0|0.776|1.285|||Cochran-Mantel-Haenszel|Stratified by RBC transfusion received within 12 months prior to randomization (yes/no) and site practice setting (nephrology/non-nephrology).|A risk ratio \< 1.0 indicates a lower event rate for the fixed dose group relative to Hb-based titration group.|||1.285|0.776|
71018492|NCT01652872|141544461|OTHER|Stratified by RBC transfusion received within 12 months prior to randomization (yes/no) and site practice setting (nephrology/non-nephrology) and accounting for participant exposure time.|Least Squares Mean (LSM) Ratio|1.28|||||TWO_SIDED|95.0|0.81|2.05|||Negative binomial regression model||Least Squares Mean (LSM) ratio is fixed dose relative to titration.|||2.05|0.81|
71018493|NCT01652872|141544462|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.76|1.35|||Cox Proportional Hazard Model|Stratified by RBC transfusion received within 12 months prior to randomization (yes/no) and site practice setting (nephrology/non-nephrology).|Hazard ratio is fixed dose relative to titration.|||1.35|0.76|
71018494|NCT01652872|141544463|OTHER||Median of the difference|-0.34|||||TWO_SIDED|95.0|-0.46|-0.22|||Hodges-Lehmann estimate||Difference is fixed dose - titration.||The 2-sided 95% confidence intervals were obtained using a non-parametric Wilcoxon rank-sum statistic.|-0.22|-0.46|
71018495|NCT01652872|141544464|OTHER||Median of the difference|-22.1|||||TWO_SIDED|95.0|-26.1|-18.1|||Hodges-Lehmann estimate||Difference is fixed dose - titration.||The 2-sided 95% confidence intervals were obtained using a non-parametric Wilcoxon rank-sum statistic.|-18.1|-26.1|
71018496|NCT04529096|141544467|SUPERIORITY||Posterior Mean Difference|0.52|||||TWO_SIDED|95.0|-0.1|1.14|||Bayesian Mixed Model Analysis|||||1.14|-0.10|
71018497|NCT04529096|141544468|SUPERIORITY||Posterior Mean Difference|1.05|||||TWO_SIDED|95.0|-0.46|2.56|||Bayesian Mixed Model Analysis|||||2.56|-0.46|
71105689|NCT00402987|141718317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.9||||0.127||95.0|-13.5|1.7||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||1.7|-13.5|0.127
71018498|NCT04529096|141544469|SUPERIORITY||Posterior Mean Difference|0.16|||||TWO_SIDED|95.0|-0.25|0.58|||Bayesian Mixed Model Analysis|||||0.58|-0.25|
71018499|NCT04529096|141544470|SUPERIORITY||Posterior Mean Difference|0.48|||||TWO_SIDED|95.0|-0.19|1.17|||Bayesian Mixed Model Analysis|||||1.17|-0.19|
71018500|NCT04529096|141544471|SUPERIORITY||Posterior Mean Difference|4.63|||||TWO_SIDED|95.0|-3.51|12.59|||Bayesian Mixed Model Analysis|||||12.59|-3.51|
71018501|NCT04529096|141544472|SUPERIORITY||Posterior Mean Difference|0.05|||||TWO_SIDED|95.0|-0.4|0.51|||Bayesian Mixed Model Analysis|||||0.51|-0.40|
71018502|NCT04529096|141544473|SUPERIORITY||Posterior Mean Difference|-15.18|||||TWO_SIDED|95.0|-206.43|175.8|||Bayesian Mixed Model Analysis|||||175.80|-206.43|
71018503|NCT04529096|141544474|SUPERIORITY||Posterior Mean Difference|-0.05|||||TWO_SIDED|95.0|-0.11|0.01|||Bayesian Mixed Model Analysis|||||0.01|-0.11|
71018504|NCT02392559|141544486|SUPERIORITY||treatment difference|-38.3|STANDARD_ERROR_OF_MEAN|3.66|<|0.0001|TWO_SIDED|95.0|-45.54|-31.06|||repeated measures model||Treatment difference uses placebo as the reference.|||-31.06|-45.54|< 0.0001
71018505|NCT02392559|141544486|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
71018506|NCT02392559|141544487|SUPERIORITY||treatment difference|-42.09|STANDARD_ERROR_OF_MEAN|3.17|<|0.0001|TWO_SIDED|95.0|-48.34|-35.83|||repeated measures model||Treatment difference uses placebo as the reference.|||-35.83|-48.34|< 0.0001
71018507|NCT02392559|141544487|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
71018508|NCT02392559|141544488|SUPERIORITY||treatment difference|-68.6|STANDARD_ERROR_OF_MEAN|7.3|<|0.0001|TWO_SIDED|95.0|-83.1|-54.0||Treatment difference uses placebo as the reference.|repeated measures model|||||-54.0|-83.1|< 0.0001
71105690|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.480
70932033|NCT02307682|141364347|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.6|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||5.3|-2.6|
70851224|NCT00669409|141190525|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-25.7|6.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.9|-25.7|
70932034|NCT02307682|141364347|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-2.1|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||5.9|-2.1|
70851225|NCT00669409|141190525|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.4|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-31.5|0.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.7|-31.5|
71018509|NCT02392559|141544488|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
71105691|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.78||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.780
71105692|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.667||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.667
71105693|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.153||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.153
70851226|NCT00669409|141190525|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-32.5|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-53.7|-11.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-11.2|-53.7|
70851227|NCT00669409|141190526|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-17.0|16.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.0|-17.0|
70851228|NCT00669409|141190526|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-21.3|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-37.6|-4.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-4.9|-37.6|
70851229|NCT00669409|141190526|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-24.1|8.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.5|-24.1|
70932035|NCT02307682|141364347|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-4.3|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||3.9|-4.3|
71105694|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.479||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.479
71105695|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.469||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.469
70851230|NCT00669409|141190526|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.1|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-32.2|0.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.0|-32.2|
71105696|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.062
71105697|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.284||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.284
70851231|NCT00669409|141190526|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-26.8|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-48.1|-5.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-5.5|-48.1|
70851232|NCT00669409|141190527|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-12.8|20.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.2|-12.8|
70851233|NCT00669409|141190527|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.5|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-34.8|-2.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.2|-34.8|
70851234|NCT00669409|141190527|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-21.7|11.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.0|-21.7|
70851235|NCT00669409|141190527|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.0|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-30.1|2.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.1|-30.1|
71052034|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.235||||0.297|TWO_SIDED|95.0|-0.68|0.21|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 14||0.21|-0.68|0.297
71052035|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.38||||0.094|TWO_SIDED|95.0|-0.82|0.07|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 15||0.07|-0.82|0.094
71052036|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.43||||0.064|TWO_SIDED|95.0|-0.89|0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 16||0.03|-0.89|0.064
71052037|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.563||||0.019|TWO_SIDED|95.0|-1.03|-0.09|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 17||-0.09|-1.03|0.019
71052038|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.457||||0.044|TWO_SIDED|95.0|-0.9|-0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 18||-0.01|-0.90|0.044
71052039|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.633||||0.007|TWO_SIDED|95.0|-1.09|-0.17|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 19||-0.17|-1.09|0.007
71052040|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.222||||0.348|TWO_SIDED|95.0|-0.69|0.24|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 20||0.24|-0.69|0.348
71052041|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.281||||0.243|TWO_SIDED|95.0|-0.76|0.19|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 21||0.19|-0.76|0.243
71052042|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.595||||0.014|TWO_SIDED|95.0|-1.07|-0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 22||-0.12|-1.07|0.014
71052043|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.474||||0.055|TWO_SIDED|95.0|-0.96|0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 23||0.01|-0.96|0.055
70851236|NCT00669409|141190527|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-24.8|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-46.0|-3.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.5|-46.0|
70851237|NCT00669409|141190528|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|9.0|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-7.5|25.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||25.5|-7.5|
70851238|NCT00669409|141190528|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.7|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-32.0|0.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.6|-32.0|
70851239|NCT00669409|141190528|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-16.7|15.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||15.9|-16.7|
71052044|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.464||||0.062|TWO_SIDED|95.0|-0.95|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 24||0.02|-0.95|0.062
71052045|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.43||||0.079|TWO_SIDED|95.0|-0.91|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 25||0.05|-0.91|0.079
71052046|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.576||||0.019|TWO_SIDED|95.0|-1.06|-0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 26||-0.10|-1.06|0.019
71052047|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48||||0.056|TWO_SIDED|95.0|-0.97|0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 27||0.01|-0.97|0.056
70932036|NCT02307682|141364347|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-3.6|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||4.8|-3.6|
71105698|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.421||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.421
71105699|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.022
70932037|NCT02307682|141364347|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.7|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.8|-3.7|
71105700|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.171||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.171
71105701|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.354||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.354
71105702|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.005
71105703|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.090
71105704|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.262||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.262
71105705|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
71105706|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.044
71105707|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.194||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.194
71018510|NCT02392559|141544489|SUPERIORITY||treatment difference|-35.04|STANDARD_ERROR_OF_MEAN|3.41|<|0.0001|TWO_SIDED|95.0|-41.79|-28.3|||repeated measures model||Treatment difference uses placebo as the reference.|||-28.30|-41.79|< 0.0001
71018511|NCT02392559|141544489|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
71018512|NCT02392559|141544490|SUPERIORITY||treatment difference|-32.47|STANDARD_ERROR_OF_MEAN|3.21|<|0.0001|TWO_SIDED|95.0|-38.82|-26.13|||repeated measures model||Treatment difference uses placebo as the reference.|||-26.13|-38.82|< 0.0001
71018513|NCT02392559|141544490|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
71018514|NCT02392559|141544491|SUPERIORITY||treatment difference|-30.3|STANDARD_ERROR_OF_MEAN|3.09|<|0.0001|TWO_SIDED|95.0|-36.4|-24.21|||repeated measures model||Treatment difference uses placebo as the reference.|||-24.21|-36.40|< 0.0001
71018515|NCT02392559|141544491|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
71018516|NCT02392559|141544492|SUPERIORITY||treatment difference|-36.38|STANDARD_ERROR_OF_MEAN|3.33|<|0.0001|TWO_SIDED|95.0|-42.97|-29.8|||repeated measures model||Treatment difference uses placebo as the reference.|||-29.80|-42.97|< 0.0001
71018517|NCT02392559|141544492|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
71018518|NCT01966107|141544501|SUPERIORITY||Rate ratio|0.65||||0.006|TWO_SIDED|95.0|0.48|0.89|||Negative Binomial Regression model||||A rate ratio \<1 represents a favorable outcome for aclidinium bromide 400 μg.|0.89|0.48|0.006
71018519|NCT01966107|141544503|NON_INFERIORITY|Estimate of the hazard ratio and its 95% CI for comparing aclidinium bromide 400 μg versus placebo were derived using the Cox proportional hazard model. A hazard ratio \<1 represents a favorable outcome for aclidinium bromide 400 μg.|Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.64|1.23||||||Composite MACE||1.23|0.64|
71018520|NCT00532779|141544504|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.67|||<|0.001||95.0|-4.5|-2.85|||ANCOVA|||||-2.85|-4.50|<0.001
71018521|NCT00532779|141544504|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.81|||<|0.001|TWO_SIDED|95.0|-5.63|-3.99|||ANCOVA|||||-3.99|-5.63|<0.001
71018522|NCT00532779|141544505|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.42|||<|0.001||95.0|2.52|4.63|||Regression, Logistic|||||4.63|2.52|<0.001
71018523|NCT00532779|141544505|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.86|||<|0.001||95.0|3.6|6.57|||Regression, Logistic|||||6.57|3.60|<0.001
71018524|NCT00532779|141544506|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.21|||<|0.001|TWO_SIDED|95.0|2.14|4.81|||Regression, Logistic|||||4.81|2.14|<0.001
70851240|NCT00669409|141190528|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-25.5|6.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.7|-25.5|
70932038|NCT02307682|141364347|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-3.7|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.7|-3.7|
71018525|NCT00532779|141544506|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.19|||<|0.001|TWO_SIDED|95.0|2.82|6.23|||Regression, Logistic|||||6.23|2.82|<0.001
71052048|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.659||||0.018|TWO_SIDED|95.0|-1.2|-0.11|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 28||-0.11|-1.20|0.018
71052049|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.222||||0.194|TWO_SIDED|95.0|-0.56|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 1||0.1|-0.56|0.194
71052050|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.263||||0.134|TWO_SIDED|95.0|-0.61|0.08|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 2||0.08|-0.61|0.134
71052051|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31||||0.091|TWO_SIDED|95.0|-0.67|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 3||0.05|-0.67|0.091
71052052|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.278||||0.131|TWO_SIDED|95.0|-0.64|0.08|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 4||0.08|-0.64|0.131
71052053|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.483|TWO_SIDED|95.0|-0.49|0.23|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 5||0.23|-0.49|0.483
71052054|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.301||||0.137|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 6||0.10|-0.70|0.137
71052055|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.297||||0.142|TWO_SIDED|95.0|-0.69|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 7||0.10|-0.69|0.142
71052056|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.245||||0.22|TWO_SIDED|95.0|-0.64|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 8||0.15|-0.64|0.220
71052057|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.373||||0.081|TWO_SIDED|95.0|-0.79|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 9||0.05|-0.79|0.081
71052058|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.453||||0.034|TWO_SIDED|95.0|-0.87|-0.04|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 10||-0.04|-0.87|0.034
71052059|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.314||||0.15|TWO_SIDED|95.0|-0.74|0.11|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 11||0.11|-0.74|0.150
70851241|NCT00669409|141190528|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-20.8|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-42.0|0.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.5|-42.0|
71018526|NCT00532779|141544507|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.58|||<|0.001|TWO_SIDED|95.0|-3.74|-1.43|||ANCOVA|||||-1.43|-3.74|<0.001
71018527|NCT00532779|141544507|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.78|||<|0.001|TWO_SIDED|95.0|-4.93|-2.64|||ANCOVA|||||-2.64|-4.93|<0.001
71018528|NCT00532779|141544508|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.42|||<|0.001|TWO_SIDED|95.0|2.17|4.66|||ANCOVA|||||4.66|2.17|<0.001
71052060|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.333||||0.111|TWO_SIDED|95.0|-0.74|0.08|||ANCOVA|||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 12||0.08|-0.74|0.111
71052061|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.261|TWO_SIDED|95.0|-0.69|0.19|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 13||0.19|-0.69|0.261
71052062|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.342||||0.123|TWO_SIDED|95.0|-0.78|0.09|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 14||0.09|-0.78|0.123
71052063|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.415||||0.056|TWO_SIDED|95.0|-0.84|0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 15||0.01|-0.84|0.056
71052064|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.566||||0.011|TWO_SIDED|95.0|-1.0|-0.13|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 16||-0.13|-1.00|0.011
71052065|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59||||0.009|TWO_SIDED|95.0|-1.03|-0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 17||-0.15|-1.03|0.009
70932039|NCT02307682|141364347|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-2.2|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||6.1|-2.2|
71018529|NCT00532779|141544508|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.48|||<|0.001|TWO_SIDED|95.0|2.26|4.7|||ANCOVA|||||4.70|2.26|<0.001
71018530|NCT00532779|141544509|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.88|||=|0.046|TWO_SIDED||||||ANCOVA|||||||=0.046
71018531|NCT00532779|141544509|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.61|||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
71018532|NCT00532779|141544510|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.13|||<|0.001|TWO_SIDED|95.0|1.72|4.54|||ANCOVA|||||4.54|1.72|<0.001
71018533|NCT00532779|141544510|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.14|||<|0.001|TWO_SIDED|95.0|2.73|5.56|||ANCOVA|||||5.56|2.73|<0.001
71018534|NCT00532779|141544511|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.36|||=|0.016|TWO_SIDED||||||ANCOVA|||||||=0.016
71018535|NCT00532779|141544511|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.32|||=|0.008|TWO_SIDED||||||ANCOVA|||||||=0.008
71018536|NCT00532779|141544512|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.27|||=|0.063|TWO_SIDED||||||ANCOVA|||||||=0.063
71018537|NCT00532779|141544512|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.57|||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
71018538|NCT00532779|141544513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09|||||TWO_SIDED|95.0|-2.6|0.42||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.42|-2.60|
71018539|NCT00532779|141544513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.94|||=|0.01|TWO_SIDED|95.0|-3.42|-0.46|||ANCOVA|||||-0.46|-3.42|=0.010
71018540|NCT00532779|141544514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.43|||||TWO_SIDED|||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||
71018541|NCT00532779|141544514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.29|||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
71018542|NCT00532779|141544515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.81|||||TWO_SIDED|95.0|-6.68|-0.94||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||-0.94|-6.68|
71018543|NCT00532779|141544515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.84|||<|0.001|TWO_SIDED|95.0|-8.71|-2.98|||ANCOVA|||||-2.98|-8.71|<0.001
71018544|NCT00532779|141544516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39|||||TWO_SIDED|95.0|-3.62|2.84||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||2.84|-3.62|
71018545|NCT00532779|141544516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.13||||0.484|TWO_SIDED|95.0|-4.29|2.04|||ANCOVA|||||2.04|-4.29|0.484
71018546|NCT00532779|141544517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.23|||||TWO_SIDED|95.0|1.16|3.3||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||3.30|1.16|
71018547|NCT00532779|141544517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.83|||||TWO_SIDED|95.0|0.76|2.9||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||2.90|0.76|
71052066|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.301||||0.175|TWO_SIDED|95.0|-0.74|0.13|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 18||0.13|-0.74|0.175
71052067|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.449||||0.039|TWO_SIDED|95.0|-0.87|-0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 19||-0.02|-0.87|0.039
71052068|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.315||||0.152|TWO_SIDED|95.0|-0.75|0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 20||0.12|-0.75|0.152
71052069|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.424||||0.063|TWO_SIDED|95.0|-0.87|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 21||0.02|-0.87|0.063
71052070|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.454||||0.044|TWO_SIDED|95.0|-0.9|-0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 22||-0.01|-0.90|0.044
71052071|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.312||||0.179|TWO_SIDED|95.0|-0.77|0.14|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 23||0.14|-0.77|0.179
70851242|NCT00669409|141190529|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|8.1|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-8.4|24.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||24.6|-8.4|
71052072|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.479||||0.034|TWO_SIDED|95.0|-0.92|-0.04|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 24||-0.04|-0.92|0.034
71052073|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.157||||0.505|TWO_SIDED|95.0|-0.62|0.31|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 25||0.31|-0.62|0.505
71052074|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.317||||0.186|TWO_SIDED|95.0|-0.79|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 26||0.15|-0.79|0.186
71052075|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.283||||0.234|TWO_SIDED|95.0|-0.75|0.18|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 27||0.18|-0.75|0.234
71052076|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.645||||0.017|TWO_SIDED|95.0|-1.17|-0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 28||-0.12|-1.17|0.017
71018548|NCT00532779|141544518|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.96|||||TWO_SIDED|95.0|0.19|1.73||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.73|0.19|
71052077|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32||||0.095|TWO_SIDED|95.0|-0.7|0.06|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 1||0.06|-0.70|0.095
71018549|NCT00532779|141544518|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9|||||TWO_SIDED|95.0|0.13|1.67||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.67|0.13|
71052078|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.231||||0.236|TWO_SIDED|95.0|-0.61|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 2||0.15|-0.61|0.236
70851243|NCT00669409|141190529|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.3|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-32.6|0.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.0|-32.6|
71052079|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.255||||0.205|TWO_SIDED|95.0|-0.65|0.14|||ANCOVA|||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 3||0.14|-0.65|0.205
71052080|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.343||||0.084|TWO_SIDED|95.0|-0.73|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 4||0.05|-0.73|0.084
71052081|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.146||||0.475|TWO_SIDED|95.0|-0.55|0.26|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 5||0.26|-0.55|0.475
71052082|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.296||||0.178|TWO_SIDED|95.0|-0.73|0.14|||ANCOVA|||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 6||0.14|-0.73|0.178
71052083|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.406||||0.071|TWO_SIDED|95.0|-0.85|0.04|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 7||0.04|-0.85|0.071
71052084|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.111||||0.621|TWO_SIDED|95.0|-0.55|0.33|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 8||0.33|-0.55|0.621
71052085|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.206||||0.372|TWO_SIDED|95.0|-0.66|0.25|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 9||0.25|-0.66|0.372
71018550|NCT00532779|141544519|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74|||||TWO_SIDED|95.0|0.19|1.28||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.28|0.19|
71018551|NCT00532779|141544519|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|||||TWO_SIDED|95.0|-0.09|1.0||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.00|-0.09|
71018552|NCT00532779|141544520|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.69|||||TWO_SIDED|95.0|0.14|1.23||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.23|0.14|
71018553|NCT00532779|141544520|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15|||||TWO_SIDED|95.0|-0.4|0.69||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.69|-0.40|
71018554|NCT00532779|141544521|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.53|0.53||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.53|-0.53|
71018555|NCT00532779|141544521|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27|||||TWO_SIDED|95.0|-0.8|0.27||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.27|-0.80|
71018556|NCT00689273|141544522|SUPERIORITY||Least Square (LS) Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.57||0.39|TWO_SIDED|80.0|-1.23|0.24|||Mixed Models Analysis|||Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect. One-sided alpha of 0.1 was used for the analysis.||0.24|-1.23|0.39
71052086|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.452||||0.046|TWO_SIDED|95.0|-0.9|-0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 10||-0.01|-0.90|0.046
71052087|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.302||||0.183|TWO_SIDED|95.0|-0.75|0.14|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 11||0.14|-0.75|0.183
71052088|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.226||||0.32|TWO_SIDED|95.0|-0.67|0.22|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 12||0.22|-0.67|0.320
71052089|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.188||||0.431|TWO_SIDED|95.0|-0.66|0.28|||ANCOVA|||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 13||0.28|-0.66|0.431
71018557|NCT00689273|141544523|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.52||0.63|TWO_SIDED|80.0|-0.92|0.42|||Mixed Models Analysis|||Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.42|-0.92|0.63
71018558|NCT00689273|141544524|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.27||0.54|TWO_SIDED|80.0|-0.51|0.18|||Mixed Models Analysis|||Week 1: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.18|-0.51|0.54
71018559|NCT00689273|141544524|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.28||0.6|TWO_SIDED|80.0|-0.51|0.21|||Mixed Models Analysis|||Week 2: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.21|-0.51|0.60
71018560|NCT00689273|141544525|SUPERIORITY||LS Mean Difference|-1.38|STANDARD_ERROR_OF_MEAN|1.8||0.44|TWO_SIDED|80.0|-3.69|0.94|||Mixed Models Analysis|||Week 1: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.94|-3.69|0.44
71018561|NCT00689273|141544525|SUPERIORITY||LS Mean Difference|-2.42|STANDARD_ERROR_OF_MEAN|2.0||0.23|TWO_SIDED|80.0|-5.0|0.16|||Mixed Models Analysis|||Week 2: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.16|-5.00|0.23
71018562|NCT00689273|141544526|SUPERIORITY||LS Mean Difference|-1.76|STANDARD_ERROR_OF_MEAN|2.46||0.48|TWO_SIDED|80.0|-4.94|1.41|||Mixed Models Analysis|||Week 1: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||1.41|-4.94|0.48
71018563|NCT00689273|141544526|SUPERIORITY||LS Mean Difference|-3.02|STANDARD_ERROR_OF_MEAN|2.79||0.28|TWO_SIDED|80.0|-6.61|0.57|||Mixed Models Analysis|||Week 2: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.57|-6.61|0.28
71052090|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.299||||0.191|TWO_SIDED|95.0|-0.75|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 14||0.15|-0.75|0.191
71052091|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.475||||0.043|TWO_SIDED|95.0|-0.94|-0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 15||-0.02|-0.94|0.043
71052092|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.619||||0.009|TWO_SIDED|95.0|-1.08|-0.16|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 16||-0.16|-1.08|0.009
71052093|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.495||||0.04|TWO_SIDED|95.0|-0.97|-0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 17||-0.02|-0.97|0.040
71052094|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.262||||0.249|TWO_SIDED|95.0|-0.71|0.18|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 18||0.18|-0.71|0.249
71052095|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.536||||0.023|TWO_SIDED|95.0|-1.0|-0.07|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 19||-0.07|-1.00|0.023
71052096|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24||||0.321|TWO_SIDED|95.0|-0.71|0.23|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 20||0.23|-0.71|0.321
71052097|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.568||||0.019|TWO_SIDED|95.0|-1.04|-0.09|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 21||-0.09|-1.04|0.019
71105708|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71052098|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.419||||0.092|TWO_SIDED|95.0|-0.91|0.07|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 22||0.07|-0.91|0.092
71052099|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.206||||0.404|TWO_SIDED|95.0|-0.69|0.28|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 23||0.28|-0.69|0.404
71052100|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.546||||0.027|TWO_SIDED|95.0|-1.03|-0.06|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 24||-0.06|-1.03|0.027
71052101|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.227||||0.357|TWO_SIDED|95.0|-0.71|0.26|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 25||0.26|-0.71|0.357
71052102|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.403||||0.114|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 26||0.10|-0.90|0.114
71052103|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.307||||0.228|TWO_SIDED|95.0|-0.81|0.19|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 27||0.19|-0.81|0.228
71052104|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.725||||0.012|TWO_SIDED|95.0|-1.29|-0.16|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 28||-0.16|-1.29|0.012
71052105|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.093||||0.643|TWO_SIDED|95.0|-0.49|0.3|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 1||0.30|-0.49|0.643
71105709|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.020
71105710|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.148||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.148
71052106|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.279||||0.15|TWO_SIDED|95.0|-0.66|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 2||0.10|-0.66|0.150
71052107|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.291||||0.162|TWO_SIDED|95.0|-0.7|0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 3||0.12|-0.70|0.162
71052108|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.244||||0.242|TWO_SIDED|95.0|-0.65|0.17|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 4||0.17|-0.65|0.242
71105711|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105712|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.009
71018564|NCT00689273|141544527|SUPERIORITY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.91||0.48|TWO_SIDED|80.0|-1.81|0.52|||Mixed Models Analysis|||Week 1: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.52|-1.81|0.48
71018565|NCT00689273|141544527|SUPERIORITY||LS Mean Difference|-1.12|STANDARD_ERROR_OF_MEAN|1.03||0.28|TWO_SIDED|80.0|-2.45|0.2|||Mixed Models Analysis|||Week 2: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.20|-2.45|0.28
71018566|NCT00689273|141544528|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.19||0.28|TWO_SIDED|80.0|-0.46|0.04|||Mixed Models Analysis|||Week 1: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.04|-0.46|0.28
71018567|NCT00689273|141544528|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.28||0.14|TWO_SIDED|80.0|-0.78|-0.06|||Mixed Models Analysis|||Week 2: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.06|-0.78|0.14
71052109|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.223||||0.278|TWO_SIDED|95.0|-0.63|0.18|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 5||0.18|-0.63|0.278
71052110|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.282||||0.2|TWO_SIDED|95.0|-0.71|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 6||0.15|-0.71|0.200
71052111|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.164||||0.456|TWO_SIDED|95.0|-0.6|0.27|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 7||0.27|-0.60|0.456
71052112|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.385||||0.076|TWO_SIDED|95.0|-0.81|0.04|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 8||0.04|-0.81|0.076
71018568|NCT00689273|141544529|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.28||0.55|TWO_SIDED|80.0|-0.52|0.19|||Mixed Models Analysis|||Day 1: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.19|-0.52|0.55
71052113|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.396||||0.084|TWO_SIDED|95.0|-0.85|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 9||0.05|-0.85|0.084
71052114|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.481||||0.04|TWO_SIDED|95.0|-0.94|-0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 10||-0.02|-0.94|0.040
70851244|NCT00669409|141190529|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-17.1|15.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||15.5|-17.1|
71018569|NCT00689273|141544529|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.28||0.11|TWO_SIDED|80.0|-0.81|-0.09|||Mixed Models Analysis|||Day 2: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.09|-0.81|0.11
71018570|NCT00689273|141544529|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.28||0.2|TWO_SIDED|80.0|-0.71|0.0|||Mixed Models Analysis|||Day 3: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.00|-0.71|0.20
71018571|NCT00689273|141544529|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.28||0.23|TWO_SIDED|80.0|-0.69|0.02|||Mixed Models Analysis|||Day 4: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.02|-0.69|0.23
71018572|NCT00689273|141544529|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_DEVIATION|0.28||0.41|TWO_SIDED|80.0|-0.58|0.13|||Mixed Models Analysis|||Day 5: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.13|-0.58|0.41
71018573|NCT00689273|141544529|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.28||0.62|TWO_SIDED|80.0|-0.49|0.22|||Mixed Models Analysis|||Day 6: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.22|-0.49|0.62
71018574|NCT00689273|141544529|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.28||0.49|TWO_SIDED|80.0|-0.55|0.16|||Mixed Models Analysis|||Day 7: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.16|-0.55|0.49
71018575|NCT00689273|141544529|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_DEVIATION|0.28||0.1|TWO_SIDED|80.0|-0.81|-0.1|||Mixed Models Analysis|||Day 8: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.10|-0.81|0.10
71018576|NCT00689273|141544529|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.28||0.24|TWO_SIDED|80.0|-0.69|0.03|||Mixed Models Analysis|||Day 9: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.03|-0.69|0.24
71052115|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.405||||0.09|TWO_SIDED|95.0|-0.87|0.06|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 11||0.06|-0.87|0.090
71052116|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.432||||0.06|TWO_SIDED|95.0|-0.88|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 12||0.02|-0.88|0.060
71052117|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.277||||0.252|TWO_SIDED|95.0|-0.75|0.2|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 13||0.20|-0.75|0.252
71105713|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.127||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.127
71105714|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105715|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
71105716|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.122||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.122
71105717|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71052118|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.229|TWO_SIDED|95.0|-0.79|0.19|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 14||0.19|-0.79|0.229
71105718|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105719|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.164||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.164
71018577|NCT00689273|141544529|SUPERIORITY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.28||0.02|TWO_SIDED|80.0|-1.01|-0.28|||Mixed Models Analysis|||Day 10: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.28|-1.01|0.02
71018578|NCT00689273|141544529|SUPERIORITY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.28||0.04|TWO_SIDED|80.0|-0.93|-0.21|||Mixed Models Analysis|||Day 11: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.21|-0.93|0.04
71018579|NCT00689273|141544529|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.28||0.04|TWO_SIDED|80.0|-0.95|-0.23|||Mixed Models Analysis|||Day 12: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.23|-0.95|0.04
71018580|NCT00689273|141544529|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.28||0.24|TWO_SIDED|80.0|-0.7|0.03|||Mixed Models Analysis|||Day 13: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.03|-0.70|0.24
71018581|NCT00689273|141544529|SUPERIORITY||Slope|-0.45|STANDARD_ERROR_OF_MEAN|0.28||0.11|TWO_SIDED|80.0|-0.82|-0.09|||Mixed Models Analysis|||Day 14: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.09|-0.82|0.11
71018582|NCT00689273|141544530|SUPERIORITY|||||||0.22|||||||Cochran-Mantel-Haenszel|||30% Reduction||||0.22
71018583|NCT00689273|141544530|SUPERIORITY|||||||0.38|||||||Cochran-Mantel-Haenszel|||50% Reduction||||0.38
71018584|NCT00689273|141544531|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.45|TWO_SIDED|80.0|-0.27|0.07|||Mixed Models Analysis|||Week 1: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.07|-0.27|0.45
71018585|NCT00689273|141544531|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.13||0.37|TWO_SIDED|80.0|-0.29|0.05|||Mixed Models Analysis|||Week 2: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.05|-0.29|0.37
71018586|NCT01238172|141544543|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.76|TWO_SIDED|95.0|0.75|1.24|||Log Rank|||||1.24|0.75|0.76
71018587|NCT01238172|141544544|SUPERIORITY||Hazard Ratio (HR)|1.41||||0.71|TWO_SIDED|95.0|0.23|8.41|||Log Rank|||||8.41|0.23|0.71
71018588|NCT01238172|141544545|SUPERIORITY|||||||0.995|||||||Wilcoxon (Mann-Whitney)|||||||0.995
71018589|NCT01238172|141544546|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|Two-sided||||||<0.001
71018590|NCT01556165|141544547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|1.32||0.0254|TWO_SIDED|75.0|-4.53|-1.47||No adjustments for multiple comparisons were made.|ANCOVA|||This study was designed to show a trend, that is, to show a clinical difference in the primary efficacy analysis, at a two-sided significance level of 0.25. Assuming a difference between rasagiline and placebo of a 3-point change in the UPDRS total score and a standard deviation on the change from baseline of 7 points, a sample size of 60 patients per treatment group gave an 88% probability of showing a trend. LOCF (last observation carried forward) was used.||-1.47|-4.53|0.0254
71018591|NCT01556165|141544548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.21||0.0032|TWO_SIDED|95.0|-1.03|-0.21|||ANCOVA|The same ANCOVA methodology as for the primary endpoint was used.||LOCF (last observation carried forward) was used.||-0.21|-1.03|0.0032
71018592|NCT01556165|141544549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.52||0.1963|TWO_SIDED|95.0|-1.7|0.35|||ANCOVA|The same ANCOVA methodology as for the primary endpoint was used.||LOCF (last observation carried forward) was used.||0.35|-1.70|0.1963
71018593|NCT01556165|141544550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71|STANDARD_ERROR_OF_MEAN|0.91||0.0641|TWO_SIDED|95.0|-3.52|0.1|||ANCOVA|The same ANCOVA methodology as for the primary endpoint was used.||LOCF (last observation carried forward) was used.||0.10|-3.52|0.0641
71018594|NCT02787746|141544610|OTHER||Odds Ratio (OR)|0.988||||0.9744|TWO_SIDED|95.0|0.466|2.095|||Regression, Logistic|||Age (\>75y vs ≤75y）||2.095|0.466|0.9744
71018595|NCT02787746|141544610|OTHER||Odds Ratio (OR)|3.42||||0.3288|TWO_SIDED|95.0|0.29|40.354|||Regression, Logistic|||APOE ɛ4 (carrier vs non-carrier)||40.354|0.290|0.3288
71018596|NCT02787746|141544610|OTHER||Odds Ratio (OR)|2.107||||0.5732|TWO_SIDED|95.0|0.158|28.171|||Regression, Logistic|||Concomitant medication：Gastrointestinal drugs||28.171|0.158|0.5732
71018597|NCT02787746|141544610|OTHER||Odds Ratio (OR)|0.976||||0.9694|TWO_SIDED|95.0|0.281|3.387|||Regression, Logistic|||Concomitant medication：Hypoglycemic drugs||3.387|0.281|0.9694
71018598|NCT02787746|141544610|OTHER||Odds Ratio (OR)|2.221||||0.0396|TWO_SIDED|95.0|1.039|4.748|||Regression, Logistic|||Concomitant medication：Cardiovascular and Cerebrovascular drugs||4.748|1.039|0.0396
71018599|NCT02787746|141544610|OTHER||Odds Ratio (OR)|2.056||||0.5889|TWO_SIDED|95.0|0.151|28.074|||Regression, Logistic|||Concomitant medication：Hepatology drugs||28.074|0.151|0.5889
71018600|NCT02787746|141544610|OTHER||Odds Ratio (OR)|1.004||||0.1181|TWO_SIDED|95.0|0.999|1.008|||Regression, Logistic|||Duration of previous donepezil 5mg/d therapy (day)||1.008|0.999|0.1181
71018601|NCT04876482|141544639|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|-10.76|||<|0.05|TWO_SIDED||||||Regression, Linear|||"We hypothesized that the improvements in the AHI would be higher in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).~."||||<0.05
71018602|NCT04876482|141544640|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|2.05|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the upper airway volume would be higher in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
71105720|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Analysis at 5 hours Pairwise comparison. No adjustment made for multiplicity.|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
70851245|NCT00669409|141190529|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-24.4|7.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.8|-24.4|
71018603|NCT04876482|141544641|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|0.275|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the minimal area on the tip of epiglottis would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls)||||<0.05
71018604|NCT04876482|141544642|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|-0.14|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the anteror to posterior distance on the tip of epiglottis would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
71018605|NCT04876482|141544643|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|0.01|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the lateral distance on the tip of epiglottis would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
71018606|NCT04876482|141544644|OTHER|Baseline characteristics among the study groups were compared using Fisher exact test for categorical variables. McNemar chi-square test used for within-group analysis.|Number and percentage|0.05|||<|0.05|TWO_SIDED||||||Fisher Exact|||We hypothesized that TORS followed by OPR would improve upper airway obstruction more compared with TORS alone and conservative treatment (control).||||<0.05
71018607|NCT04876482|141544645|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|2.23|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the jaw opening muscle strength would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
70851246|NCT00669409|141190529|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-38.0|4.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.5|-38.0|
70851247|NCT00669409|141190530|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|8.8|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-7.7|25.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||25.3|-7.7|
71018608|NCT04876482|141544646|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|2.45|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the tongue protrusion muscle strength would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
71018609|NCT04876482|141544647|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|4.81|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the tongue elevation muscle strength would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
71018610|NCT04876482|141544648|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|7.01|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the tongue depression muscle strength would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
71105721|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105722|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.244||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.244
71018611|NCT04876482|141544649|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|3.67|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the tongue lateralization muscle strength would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
71018612|NCT02038959|141544690|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANCOVA|||||||>0.05
71018613|NCT02038959|141544695|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71105723|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105724|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105725|NCT00402987|141718318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.336||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.336
71105726|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71018614|NCT01788163|141544757|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|81.1237||||0.0001||||||Histology: Adenocarcinoma vs Non-adenocarcinoma|Regression stepwise|10% significance level for entry criteria||||||0.0001
71018615|NCT01788163|141544757|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.973||||0.0001||||||Histology: Adenocarcinoma vs Non-adenocarcinoma|Regression stepwise|10% significance level for model entry||||||0.0001
71018616|NCT01788163|141544757|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|7.1526||||0.0075||||||Gender: Male vs. Female|Regression Stepwise|10% significance level for entry criteria||||||0.0075
71018617|NCT01788163|141544757|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.409||||0.0075||||||Gender: Male vs. Female|Regression Stepwise|10% Significance Level for model entry||||||0.0075
71018618|NCT01788163|141544757|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|51.8456||||0.0001||||||Smoking Status: Never-smoker vs. Ever-smoker|Regression Stepwise|10% significance level for entry criteria||||||0.0001
71018619|NCT01788163|141544757|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.515||||0.0001||||||Smoking Status: Never-smoker vs. Ever-smoker|Regression Stepwise|10% Significance Level for model entry||||||0.0001
71105727|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105728|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.090
71105729|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.518||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.518
71105730|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.038
71105731|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.019
71018620|NCT01788163|141544757|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|98.1065||||0.0001||||||Region: Asia Pacific vs. Russia|Regression Stepwise|10% Significance Level for entry criteria||||||0.0001
71018621|NCT01788163|141544757|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.929||||0.0001||||||Region: Asia Pacific vs. Russia|Regression Stepwise|10% Significance Level for model entry||||||0.0001
71105732|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71018622|NCT01788163|141544757|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|2.8589||||0.0909||||||Number of organs with metastasis|Regression Stepwise|10% significance level for entry criteria||||||0.0909
71018623|NCT01788163|141544757|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.086||||0.0909||||||Number of organs with metastasis|Regression Stepwise|10% significance level for model entry||||||0.0909
71018624|NCT01788163|141544760|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|11.106||||0.0009||||||Age: \<=65 vs. \>65|Regression Stepwise|10% Significance Level for entry criteria||||||0.0009
71018625|NCT01788163|141544760|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.561||||0.0009||||||Age: \<=65 vs. \>65|Regression Stepwise|10% Significance Level for model entry||||||0.0009
71018626|NCT01788163|141544760|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|34.1075||||0.0001||||||Number of Organs with Metastisis|Regression Stepwise|10% Significance Level for entry criteria||||||0.0001
71018627|NCT01788163|141544760|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.386||||0.0001||||||Number of Organs with Metastisis|Regression Stepwise|10% significance level for model entry||||||0.0001
71018628|NCT01788163|141544760|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|14.0806||||0.0002||||||Histology: Adenocarcinoma vs. Non-adenocarcinoma|Regression Stepwise|10% Significance Level for entry criteria||||||0.0002
71018629|NCT01788163|141544760|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.955||||0.0002||||||Histology: Adenocarcinoma vs. Non-adenocarcinoma|Regression Stepwise|10% Significance Level for model entry||||||0.0002
71105733|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105734|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.081||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.081
71105735|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.552||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.552
71105736|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.050
71052119|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.373||||0.109|TWO_SIDED|95.0|-0.83|0.08|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 15||0.08|-0.83|0.109
71105737|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.027
71018630|NCT01788163|141544760|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|33.8574||||0.0001||||||Smoking Status: Never-smoker vs. Ever-smoker|Regression Stepwise|10% Significance Level for entry criteria||||||0.0001
71018631|NCT01788163|141544760|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.077||||0.0001||||||Smoking Status: Never-smoker vs. Ever-smoker|Regression Stepwise|10% Significance Level for model entry||||||0.0001
71018632|NCT01788163|141544760|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|21.2537||||0.0001||||||Region: Asia Pacific vs. Russia|Regression Stepwise|10% Significance Level for entry criteria||||||0.0001
71018633|NCT01788163|141544760|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.084||||0.0001||||||Region: Asia Pacific vs. Russia|Regression Stepwise|10% Significance Level for model entry||||||0.0001
71018634|NCT00545441|141544765|NON_INFERIORITY_OR_EQUIVALENCE|Alpha = 0.05 and power = 0.8, a non-inferiority margin of 10%.||||||0.59|TWO_SIDED||||||Fisher Exact|||||||0.59
71052120|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.484|||||TWO_SIDED|95.0|-0.96|-0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 16||-0.01|-0.96|
71105738|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105739|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105740|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.071||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.071
71105741|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.609||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.609
71105742|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.065||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.065
71018635|NCT03610646|141544770|EQUIVALENCE|An equivalence margin of \[-3, 3\] letters was used to demonstrate equivalence for the difference of mean change in BCVA, from baseline to Week 8.|Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|90.0|-1.16|1.24||||||||1.24|-1.16|
71018636|NCT00467038|141544778|SUPERIORITY_OR_OTHER||||||<|0.004|TWO_SIDED||||||t-test, 1 sided|\<0.004 p value was common for all time points.||||||<0.004
71018637|NCT00467038|141544779|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Fisher's LSD post-hoc, trend level|||||||0.08
71018638|NCT04071366|141544801|SUPERIORITY||Difference in CRS rate|-0.39||||0.003|TWO_SIDED|95.0|-0.6463|-0.1363|||One-sided Z-test|||||-0.1363|-0.6463|0.0030
71018639|NCT04071366|141544801|OTHER||Difference in CRS rate|-0.37|||||TWO_SIDED|95.0|-0.6073|-0.1231||||||||-0.1231|-0.6073|
71018640|NCT04071366|141544801|OTHER||Difference in CRS rate|0.03|||||TWO_SIDED|95.0|-0.1778|0.2299||||||||0.2299|-0.1778|
71018641|NCT02499406|141544845|SUPERIORITY||||||>|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired sample t-test|df=14||Null hypothesis is that there is no difference between baseline assessment and this 3-month assessment.||||>0.016
71018642|NCT02499406|141544846|SUPERIORITY||||||<|0.016||||||p value was calculated and found to be below the a priori threshold for significance, which was adjusted to p = .016 for multiple comparisons|paired sample t-test|df=11||Null hypothesis is that there is no difference between baseline assessment and this 6-month assessment.||||<0.016
71018643|NCT02499406|141544847|SUPERIORITY||||||<|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired sample t-test|df=11||Null hypothesis is that there is no difference between baseline assessment and this 9-month assessment.||||<0.016
71018644|NCT02499406|141544848|SUPERIORITY||||||<|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired samples t test|df=14||Null hypothesis is that there is no difference in paired samples between baseline and 3-month assessment||||<0.016
71018645|NCT02499406|141544849|SUPERIORITY||||||<|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired samples t test|df=10||Null hypothesis is no difference between baseline and this 6-month assessment.||||<0.016
71018646|NCT02499406|141544850|SUPERIORITY||||||<|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired samples t test|df=11||Null hypothesis is no difference between baseline and this 9-month assessment.||||<0.016
71018647|NCT02499406|141544851|SUPERIORITY||||||>|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired sample t test|df=14||Null hypothesis is that there is no difference between baseline assessment and this 3-month assessment.||||> 0.016
71052121|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.003|TWO_SIDED|95.0|-1.17|-0.23|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 17||-0.23|-1.17|0.003
71105743|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.042||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.042
71105744|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105745|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105746|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.070
71105747|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.689||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.689
71105748|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.075||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Continuous data were analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.075
71105749|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.059||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.059
71105750|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105751|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
70851248|NCT00669409|141190530|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-12.9|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-29.2|3.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.5|-29.2|
71105752|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.069||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.069
71105753|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.762||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.762
71105754|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.089||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.089
71105755|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.083||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.083
71105756|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105757|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71105758|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.064
71105759|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.841||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.841
71105760|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.110
71105761|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.119||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.119
71105762|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
71105763|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.015
71105764|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.087||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.087
71105765|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.826||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.826
71105766|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.345||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.345
70932040|NCT02307682|141364347|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-2.9|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||5.3|-2.9|
70932041|NCT02307682|141364347|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.5|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.8|-3.5|
71018648|NCT02499406|141544852|SUPERIORITY||||||=|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired sample t-test|df=10||Null hypothesis is that there is no difference between baseline assessment and this 6-month assessment.||||=.016
71052122|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.326||||0.182|TWO_SIDED|95.0|-0.81|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 18||0.15|-0.81|0.182
71052123|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.299||||0.194|TWO_SIDED|95.0|-0.75|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 19||0.15|-0.75|0.194
71052124|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.348||||0.129|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 20||0.10|-0.80|0.129
71052125|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.292||||0.232|TWO_SIDED|95.0|-0.77|0.19|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 21||0.19|-0.77|0.232
71052126|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.499||||0.042|TWO_SIDED|95.0|-0.98|-0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 22||-0.02|-0.98|0.042
71052127|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.356||||0.15|TWO_SIDED|95.0|-0.84|0.13|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 23||0.13|-0.84|0.150
71052128|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.398||||0.09|TWO_SIDED|95.0|-0.86|0.06|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 24||0.06|-0.86|0.090
71052129|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.028||||0.909|TWO_SIDED|95.0|-0.52|0.46|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 25||0.46|-0.52|0.909
71052130|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.233||||0.354|TWO_SIDED|95.0|-0.73|0.26|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 26||0.26|-0.73|0.354
71052131|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29||||0.245|TWO_SIDED|95.0|-0.78|0.2|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 27||0.20|-0.78|0.245
71052132|NCT00117325|141609191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.601||||0.038|TWO_SIDED|95.0|-1.17|-0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 28||-0.03|-1.17|0.038
71105767|NCT00402987|141718319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.530
70932042|NCT02307682|141364347|OTHER||Difference in proportions|3.0|||||TWO_SIDED|95.0|-1.6|7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||7.3|-1.6|
71018649|NCT02499406|141544853|SUPERIORITY||||||<|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired sample t-test|df=11||Null hypothesis is that there is no difference between baseline assessment and this 9-month assessment.||||<0.016
71018650|NCT00663039|141544866|SUPERIORITY|||||||0.758|||||||Wilcoxon (Mann-Whitney)|||Comparison of Overall Affect Scores between Oxytocin and Placebo Arms||||0.758
71052133|NCT02338193|141609216|SUPERIORITY||||||<|0.032|||||||ANOVA|||One Way ANOVA with Bonferroni contrast if p\>0.05||||<0.032
71052134|NCT02338193|141609217|SUPERIORITY||||||<|0.05|||||||ANOVA|One Way ANOVA with Bonferoni contrast test||||||<0.05
71052135|NCT02338193|141609218|SUPERIORITY||||||<|0.01|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.01
71052136|NCT02338193|141609219|SUPERIORITY||||||<|0.012|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.012
71052137|NCT02338193|141609220|SUPERIORITY|||||||0.007|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.007
71052138|NCT02338193|141609221|SUPERIORITY|||||||0.023|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast||||0.023
71052139|NCT02338193|141609222|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast||||>0.05
71052140|NCT02338193|141609223|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast||||>0.05
71052141|NCT02338193|141609224|SUPERIORITY||||||<|0.001|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast||||<0.001
71052142|NCT02338193|141609225|SUPERIORITY||||||<|0.001|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.001
71052143|NCT02338193|141609226|SUPERIORITY||||||<|0.004|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.004
71105768|NCT00402987|141718320|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.73||||0.149||95.0|0.8|3.7|||Regression, Logistic|Treatment as a factor||||3.7|0.8|0.149
71052144|NCT02338193|141609227|SUPERIORITY||||||<|0.02|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.02
70851249|NCT00669409|141190530|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-15.8|16.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.8|-15.8|
70932043|NCT02307682|141364347|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-2.3|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.2|-2.3|
71052145|NCT02338193|141609228|SUPERIORITY||||||<|0.012|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.012
71052146|NCT02338193|141609229|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||>0.05
71052147|NCT02338193|141609230|SUPERIORITY||||||<|0.028|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.028
71052148|NCT02338193|141609231|SUPERIORITY||||||<|0.03|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<.03
71052149|NCT05084716|141609241|SUPERIORITY||Odds Ratio (OR)|5.03|||<|0.0001|TWO_SIDED|95.0|2.08|12.13|||Regression, Logistic|||||12.13|2.08|<.0001
71052150|NCT05084716|141609241|SUPERIORITY||Odds Ratio (OR)|7.6|||<|0.0001|TWO_SIDED|95.0|3.48|16.59|||Regression, Logistic|||||16.59|3.48|<.0001
71052151|NCT05084716|141609242|SUPERIORITY||Odds Ratio (OR)|12.88|||<|0.0001|TWO_SIDED|95.0|5.96|27.85|||Regression, Logistic|||||27.85|5.96|<.0001
71105769|NCT00402987|141718320|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.95||||0.076||95.0|0.9|4.1|||Regression, Logistic|Treatment as a factor||||4.1|0.9|0.076
71105770|NCT00402987|141718320|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.733||95.0|0.6|2.2|||Regression, Logistic|Treatment as a factor||||2.2|0.6|0.733
71105771|NCT00402987|141718321|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.33||||0.03||95.0|1.1|5.0|||Regression, Logistic|Treatment as a factor||||5.0|1.1|0.030
71105772|NCT00402987|141718321|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.33||||0.064||95.0|1.0|5.7|||Regression, Logistic|Treatment as a factor||||5.7|1.0|0.064
71105773|NCT00402987|141718321|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.83||||0.201||95.0|0.7|4.6|||Regression, Logistic|Treatment as a factor||||4.6|0.7|0.201
71105774|NCT00402987|141718321|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.575||95.0|0.5|3.0|||Regression, Logistic|Treatment as a factor||||3.0|0.5|0.575
71052152|NCT05084716|141609242|SUPERIORITY||Odds Ratio (OR)|1.78||||0.001|TWO_SIDED|95.0|1.26|2.52|||Regression, Logistic|||||2.52|1.26|.001
71052153|NCT05084716|141609243|SUPERIORITY||Cohen's d for difference in proportions|1.28|||<|0.0001|TWO_SIDED|||||Odds Ratio is undefined and p-value from Fisher's Exact test is reported because 0% of PrEP users had ≥80% medication coverage pre-intervention.|Fisher Exact|||||||<.0001
71052154|NCT05084716|141609243|SUPERIORITY||Odds Ratio (OR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.16|0.34|||Regression, Logistic|||||0.34|0.16|<.0001
71052155|NCT04380090|141609295|SUPERIORITY||Odds Ratio (OR)|1.37||||0.41|TWO_SIDED|95.0|0.65|2.86|||Regression, Logistic||OR for Propylene Glycol use (vs Docusate Sodium), adjusted for operative time and sex (female vs. male)|||2.86|0.65|0.41
71052156|NCT04380090|141609296|SUPERIORITY||Odds Ratio (OR)|0.79||||0.66|TWO_SIDED|95.0|0.28|2.24|||ordinal regression model||OR for Propylene Glycol use (vs Docusate Sodium), adjusted for operative time and sex (female vs. male)|||2.24|0.28|0.66
71052157|NCT04380090|141609297|SUPERIORITY||Odds Ratio (OR)|1.28||||0.65|TWO_SIDED|95.0|0.45|3.63|||ordinal regression model||OR for Propylene Glycol use (vs Docusate Sodium), adjusted for operative time and sex (female vs. male)|||3.63|0.45|0.65
71052158|NCT04380090|141609298|EQUIVALENCE|Equivalence is defined as a p-value greater or equal to 0.05 (no difference between groups)||||||0.47|||||||Chi-squared|||||||0.47
71052159|NCT04380090|141609299|EQUIVALENCE|Equivalence is defined as a p-value greater or equal to 0.05 (no difference between groups)||||||0.99|||||||Fisher Exact|||||||0.99
71052160|NCT04795908|141609301|NON_INFERIORITY|looking for statistical significant differences between groups||||||0.1997|||||||ANOVA|||||||0.1997
71052161|NCT04795908|141609302|NON_INFERIORITY|looking for statistical significant differences between groups||||||0.076|||||||ANOVA|||||||0.076
71052162|NCT04795908|141609303|NON_INFERIORITY|looking for statistically significant differences between groups||||||0.6228|||||||ANOVA|||||||0.6228
71052163|NCT04795908|141609304|NON_INFERIORITY|looking for statistically significant differences between groups||||||0.8984|||||||ANOVA|||||||0.8984
71052164|NCT04795908|141609305|NON_INFERIORITY|looking for statistically significant differences between groups||||||0.8188|||||||ANOVA|||||||0.8188
71018651|NCT00663039|141544866|SUPERIORITY|||||||0.779|||||||Wilcoxon (Mann-Whitney)|||Comparison of Overall Social Skill scores between Oxytocin and Placebo arms||||0.779
71018652|NCT00663039|141544867|SUPERIORITY|||||||0.578|||||||Wilcoxon (Mann-Whitney)|||Comparison of HVLT Trial 1 scores between Oxytocin and Placebo Arms||||0.578
71018653|NCT00663039|141544867|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Comparison of HVLT Trial 2 scores between Oxytocin and Placebo Arms||||0.28
71018654|NCT00663039|141544867|SUPERIORITY|||||||0.707|||||||Wilcoxon (Mann-Whitney)|||Comparison of HVLT Trial 3 scores between Oxytocin and Placebo Arms||||0.707
71018655|NCT00663039|141544868|SUPERIORITY|||||||0.391|||||||Wilcoxon (Mann-Whitney)|||Comparison of the total amount of money offered during the trust game between the Oxytocin and Placebo arms||||0.391
71052165|NCT04795908|141609306|NON_INFERIORITY|Looking for statistically significant differences between groups||||||0.0288|||||||ANOVA|||||||0.0288
71052166|NCT04795908|141609307|NON_INFERIORITY|looking for statistically significant differences between groups||||||0.0524|||||||ANOVA|||||||0.0524
71052167|NCT02800213|141609317|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||||||0.280
71052168|NCT00536263|141609318|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.008||||0.86|TWO_SIDED|95.0|-0.063|0.079||P-values are unadjusted; Hochberg's adjustment for multiple comparisons was used to maintain the overall 0.05 significance level in test of superiority using the Cochran-Mantel-Haenszel test.|Cochran-Mantel-Haenszel|Stratified by genotype||"Null hypothesis: no difference in the proportion with HBeAg loss.~Based on the targeted sample size, there was 80% statistical power (2-sided 0.05 alpha) to detect a true 36% HBeAg loss rate in this treatment arm versus a true rate of 23% in the control arm."||0.079|-0.063|0.860
71105775|NCT00402987|141718321|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0||||1||95.0|0.4|2.2|||Regression, Logistic|Treatment as a factor||||2.2|0.4|1.000
71105776|NCT00402987|141718321|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.624||95.0|0.5|3.3|||Regression, Logistic|Treatment as a factor||||3.3|0.5|0.624
71105777|NCT00402987|141718322|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.28|||<|0.001||95.0|0.7|1.9||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||1.9|0.7|<0.001
71105778|NCT00402987|141718322|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.88||||0.003||95.0|0.3|1.5||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||1.5|0.3|0.003
71105779|NCT00402987|141718322|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.177||95.0|-1.0|0.2||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||0.2|-1.0|0.177
71105780|NCT00402987|141718322|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.25|||<|0.001||95.0|3.0|7.5||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||7.5|3.0|<0.001
71105781|NCT00402987|141718322|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.54|||<|0.001||95.0|2.3|6.8||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||6.8|2.3|<0.001
71105782|NCT00402987|141718322|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.72||||0.531||95.0|-3.0|1.5||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||1.5|-3.0|0.531
71105783|NCT00402987|141718323|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.07|||<|0.001||95.0|4.4|13.7||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||13.7|4.4|<0.001
71105784|NCT00402987|141718323|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.46|||<|0.001||95.0|4.7|16.2||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||16.2|4.7|<0.001
71018656|NCT00663039|141544869|SUPERIORITY|||||||0.559|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean Target Reaction Time between Oxytocin and Placebo arms.||||0.559
71018657|NCT00663039|141544869|SUPERIORITY|||||||0.858|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean Target Reaction Time between Oxytocin and Placebo arms.||||0.858
71018658|NCT00663039|141544869|SUPERIORITY|||||||0.514|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean False Alarms Reaction Time between Oxytocin and Placebo arms||||0.514
71018659|NCT00663039|141544869|SUPERIORITY|||||||0.088|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean False Alarms Reaction Time between Oxytocin and Placebo arms||||0.088
71018660|NCT00663039|141544870|SUPERIORITY|||||||0.296|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean Target Hits between Oxytocin and Placebo arms.||||0.296
71018661|NCT00663039|141544870|SUPERIORITY|||||||0.136|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean Target Hits between Oxytocin and Placebo arms.||||0.136
71018662|NCT00663039|141544870|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean False Alarms between Oxytocin and Placebo arms.||||0.47
71018663|NCT00663039|141544870|SUPERIORITY|||||||0.702|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean Target Hits between Oxytocin and Placebo arms.||||0.702
71018664|NCT00663039|141544871|SUPERIORITY|||||||0.451|||||||Wilcoxon (Mann-Whitney)|||Comparison of Brief Assessments of Cognition for Schizophrenia scores between the Oxytocin and Placebo arms.||||0.451
71018665|NCT00663039|141544872|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.9
71018666|NCT00663039|141544873|SUPERIORITY|||||||0.946|||||||Wilcoxon (Mann-Whitney)|||Comparison of Reading the Mind in the Eyes total scores between Oxytocin and Placebo arms||||0.946
71018667|NCT00663039|141544874|SUPERIORITY|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||Comparison the Facial Affect Recognition Total scores between Oxytocin and Placebo arms||||0.016
70932044|NCT02307682|141364347|OTHER||Difference in proportions|2.5|||||TWO_SIDED|95.0|-2.2|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.7|-2.2|
70932045|NCT02307682|141364347|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-4.8|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.8|-4.8|
70932046|NCT02307682|141364347|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-3.8|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||5.9|-3.8|
70932047|NCT02307682|141364347|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-3.1|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.7|-3.1|
71018668|NCT00663039|141544874|SUPERIORITY|||||||0.185|||||||Wilcoxon (Mann-Whitney)|||Comparison the Facial Affect Recognition Hits between Oxytocin and Placebo arms||||0.185
71018669|NCT00663039|141544874|SUPERIORITY|||||||0.404|||||||Wilcoxon (Mann-Whitney)|||Comparison the Facial Affect Recognition False Alarms between Oxytocin and Placebo arms||||0.404
71018670|NCT05016765|141544891|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|paired t-test||||||<0.001
71018671|NCT05016765|141544891|OTHER|Pearson correlation test|Pearson's R|0.21||||0.33|TWO_SIDED|95.0|-0.22|0.56|||Regression, Linear|Pearson's R||Correlation of this Outcome measure (change in tic frequency with stimulation during this study) with the change in tic frequency (measured as the number of 10-second tic-free intervals) during active, rhythmic stimulation in the randomized, controlled trial of MNS that all participants had previously completed.||0.56|-0.22|0.33
71018672|NCT05016765|141544892|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Paired Samples Wilcoxon Test||||||<0.001
71018673|NCT05016765|141544892|OTHER|Pearson's R|Pearson's R|0.36||||0.08|TWO_SIDED|95.0|-0.05|0.66|||Regression, Linear|Pearson's R||Correlation of this Outcome measure (change in tic intensity during this study) with change in tic intensity during active, rhythmic stimulation during the randomized, controlled trial that all participants had previously completed.||0.66|-0.05|0.08
71018674|NCT05016765|141544897|OTHER|Traditional comparative||||||0.84|||||||Paired Sample t-Test, 2-Sided|||||||0.84
71018675|NCT00038467|141544921|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||3e-05|TWO_SIDED|95.0|0.58|0.82|||Log Rank|||||0.82|0.58|0.00003
71105785|NCT00402987|141718323|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.96||||0.041||95.0|0.2|11.7||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||11.7|0.2|0.041
71018676|NCT00038467|141544922|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.913||||0.15737|TWO_SIDED|95.0|0.806|1.036|||Log Rank|||||1.036|0.806|0.15737
71018677|NCT00038467|141544924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.43|||<|0.0001|TWO_SIDED|95.0|1.63|3.23|||t-test, 2 sided|||6 months on-treatment (lumbar spine): p-value was estimated using 2-sided t-test.||3.23|1.63|<0.0001
71018678|NCT00038467|141544924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.18||||0.0002|TWO_SIDED|95.0|0.57|1.79|||t-test, 2 sided|||6 months on-treatment (total hip): p-value was estimated using 2-sided t-test.||1.79|0.57|0.0002
71018679|NCT00038467|141544924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.79|||<|0.0001|TWO_SIDED|95.0|1.77|3.81|||t-test, 2 sided|||12 months on-treatment (lumbar spine): p-value was estimated using 2-sided t-test.||3.81|1.77|<0.0001
71018680|NCT00038467|141544924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.79|||<|0.0001|TWO_SIDED|95.0|1.12|2.46|||t-test, 2 sided|||12 months on-treatment (total hip): p-value was estimated using 2-sided t-test.||2.46|1.12|<0.0001
71018681|NCT00038467|141544924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.22|||<|0.0001|TWO_SIDED|95.0|2.1|4.35|||t-test, 2 sided|||24 months on-treatment (lumbar spine): p-value was estimated using 2-sided t-test.||4.35|2.10|<0.0001
71018682|NCT00038467|141544924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|||<|0.0001|TWO_SIDED|95.0|1.1|2.69|||t-test, 2 sided|||24 months on-treatment (total hip): p-value was estimated using 2-sided t-test.||2.69|1.10|<0.0001
71018683|NCT00038467|141544933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.5|TWO_SIDED|95.0|-1.76|0.86|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.86|-1.76|0.500
71018684|NCT00038467|141544933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.009|TWO_SIDED|95.0|-3.67|-0.52|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||-0.52|-3.67|0.009
71018685|NCT00038467|141544933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35||||0.079|TWO_SIDED|95.0|-2.86|0.16|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.16|-2.86|0.079
71018686|NCT00038467|141544933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.729|TWO_SIDED|95.0|-1.24|1.77|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||1.77|-1.24|0.729
71018687|NCT00038467|141544933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84||||0.302|TWO_SIDED|95.0|-2.43|0.75|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.75|-2.43|0.302
71018688|NCT00038467|141544933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.187|TWO_SIDED|95.0|-2.76|0.54|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.54|-2.76|0.187
71018689|NCT00038467|141544934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.26|TWO_SIDED|95.0|-1.8|0.49|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.49|-1.80|0.260
71018690|NCT00038467|141544934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.209|TWO_SIDED|95.0|-2.02|0.44|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||0.44|-2.02|0.209
71018691|NCT00038467|141544934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.698|TWO_SIDED|95.0|-1.38|0.92|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.92|-1.38|0.698
70932048|NCT02307682|141364347|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-2.8|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||6.4|-2.8|
70932049|NCT02307682|141364347|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-3.4|5.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||5.2|-3.4|
70932050|NCT02307682|141364347|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-2.8|6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||6.6|-2.8|
70932051|NCT02307682|141364347|OTHER||Difference in proportions|-1.9|||||TWO_SIDED|95.0|-6.6|2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||2.5|-6.6|
70932052|NCT02307682|141364347|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-6.1|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||3.8|-6.1|
70932053|NCT02307682|141364347|OTHER||Difference in proportions|-1.1|||||TWO_SIDED|95.0|-5.6|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||3.1|-5.6|
71018692|NCT00038467|141544934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83||||0.192|TWO_SIDED|95.0|-0.42|2.09|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||2.09|-0.42|0.192
70932054|NCT02307682|141364347|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-2.9|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||6.9|-2.9|
70932055|NCT02307682|141364347|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-5.8|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||3.1|-5.8|
70932056|NCT02307682|141364347|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-3.2|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.5|-3.2|
71052169|NCT00536263|141609318|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.139|||<|0.001|TWO_SIDED|95.0|0.061|0.217||P-values are unadjusted; Hochberg's adjustment for multiple comparisons was used to maintain the overall 0.05 significance level in test of superiority using the Cochran-Mantel-Haenszel test.|Cochran-Mantel-Haenszel|Stratified by genotype||"Null hypothesis: no difference in the proportion with HBeAg loss.~Based on the targeted sample size, there was 80% statistical power (2-sided 0.05 alpha) to detect a true 36% HBeAg loss rate in this treatment arm versus a true rate of 23% in the control arm."||0.217|0.061|<0.001
70932057|NCT02307682|141364347|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-4.2|5.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||5.0|-4.2|
70932058|NCT02307682|141364347|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-3.2|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||6.7|-3.2|
70932059|NCT02307682|141364347|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-5.8|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||4.2|-5.8|
71018693|NCT00038467|141544934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.813|TWO_SIDED|95.0|-1.46|1.15|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||1.15|-1.46|0.813
71018694|NCT00038467|141544934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.537|TWO_SIDED|95.0|-0.91|1.75|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||1.75|-0.91|0.537
71018695|NCT00038467|141544935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.727|TWO_SIDED|95.0|-3.46|2.42|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||2.42|-3.46|0.727
71018696|NCT00038467|141544935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.08||||0.047|TWO_SIDED|95.0|-6.12|-0.05|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||-0.05|-6.12|0.047
71018697|NCT00038467|141544935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.553|TWO_SIDED|95.0|-3.88|2.08|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||2.08|-3.88|0.553
71052170|NCT00536263|141609318|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority of PEG 1.5 mcg/kg\*24 weeks with respect to PEG 1.5 mcg/kg\*48 weeks was to be concluded if the lower bound of the one-sided 95% confidence interval of the difference of the rates (PEG 1.5 mcg/kg\*24 weeks minus PEG 1.5 mcg/kg\*48 weeks) was greater than the noninferiority margin of -10%.|Pairwise rate difference|-0.132|||||TWO_SIDED|90.0|-0.198|-0.065||||||||-0.065|-0.198|
71018698|NCT00038467|141544935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91||||0.563|TWO_SIDED|95.0|-2.17|3.99|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||3.99|-2.17|0.563
71018699|NCT00038467|141544935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73||||0.643|TWO_SIDED|95.0|-3.83|2.36|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||2.36|-3.83|0.643
71018700|NCT00038467|141544935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.91||||0.126|TWO_SIDED|95.0|-6.63|0.82|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.82|-6.63|0.126
71018701|NCT00038467|141544936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.265|TWO_SIDED|95.0|-0.83|0.23|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.23|-0.83|0.265
71018702|NCT00038467|141544936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.0002|TWO_SIDED|95.0|-1.84|-0.57|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||-0.57|-1.84|0.0002
71018703|NCT00038467|141544936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.132|TWO_SIDED|95.0|-1.0|0.13|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.13|-1.00|0.132
71018704|NCT00038467|141544936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.635|TWO_SIDED|95.0|-0.7|0.43|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||0.43|-0.70|0.635
71018705|NCT00038467|141544936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.449|TWO_SIDED|95.0|-0.75|0.33|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.33|-0.75|0.449
71018706|NCT00038467|141544936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.454|TWO_SIDED|95.0|-0.81|0.36|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.36|-0.81|0.454
71018707|NCT00038467|141544937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.712|TWO_SIDED|95.0|-0.53|0.335|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.335|-0.53|0.712
71018708|NCT00038467|141544937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.899|TWO_SIDED|95.0|-0.65|0.356|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||0.356|-0.65|0.899
71018709|NCT00038467|141544937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.882|TWO_SIDED|95.0|-0.76|0.359|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.359|-0.76|0.882
71018710|NCT00038467|141544937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.604|TWO_SIDED|95.0|-0.54|0.37|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.37|-0.54|0.604
71018711|NCT00038467|141544937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.562|TWO_SIDED|95.0|-1.16|0.454|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.454|-1.16|0.562
71018712|NCT00038467|141544938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.892|TWO_SIDED|95.0|-0.2|0.18|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.18|-0.20|0.892
71018713|NCT00038467|141544938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.881|TWO_SIDED|95.0|-0.21|0.24|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||0.24|-0.21|0.881
71018714|NCT00038467|141544938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.883|TWO_SIDED|95.0|-0.18|0.21|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.21|-0.18|0.883
71018715|NCT00038467|141544938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.604|TWO_SIDED|95.0|-0.16|0.27|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||0.27|-0.16|0.604
71018716|NCT00038467|141544938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.118|TWO_SIDED|95.0|-0.05|0.41|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.41|-0.05|0.118
71018717|NCT00038467|141544938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.307|TWO_SIDED|95.0|-0.11|0.34|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.34|-0.11|0.307
71018718|NCT00038467|141544939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.792|TWO_SIDED|95.0|-0.42|0.56|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.56|-0.42|0.792
71018719|NCT00038467|141544939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.405|TWO_SIDED|95.0|-0.76|0.31|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||0.31|-0.76|0.405
71018720|NCT00038467|141544939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.484|TWO_SIDED|95.0|-0.75|0.36|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.36|-0.75|0.484
71018721|NCT00038467|141544939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.229|TWO_SIDED|95.0|-0.19|0.8|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||0.80|-0.19|0.229
71018722|NCT00038467|141544939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.381|TWO_SIDED|95.0|-0.84|0.32|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.32|-0.84|0.381
71018723|NCT00038467|141544939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.405|TWO_SIDED|95.0|-0.82|0.33|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.33|-0.82|0.405
71018724|NCT00038467|141544940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.648|TWO_SIDED|95.0|-0.77|0.48|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.48|-0.77|0.648
71018725|NCT00038467|141544940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.366|TWO_SIDED|95.0|-1.08|0.4|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||0.40|-1.08|0.366
71018726|NCT00038467|141544940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.062|TWO_SIDED|95.0|-1.33|0.03|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.03|-1.33|0.062
71018727|NCT00038467|141544940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.545|TWO_SIDED|95.0|-0.53|1.0|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||1.00|-0.53|0.545
71018728|NCT00038467|141544940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.932|TWO_SIDED|95.0|-0.77|0.7|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.70|-0.77|0.932
71018729|NCT00038467|141544940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.244|TWO_SIDED|95.0|-1.24|0.32|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.32|-1.24|0.244
71018730|NCT00038467|141544941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.876|TWO_SIDED|95.0|-0.62|0.73|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.73|-0.62|0.876
70851250|NCT00669409|141190530|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-23.6|8.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.6|-23.6|
71018731|NCT00038467|141544941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.195|TWO_SIDED|95.0|-1.25|0.26|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||0.26|-1.25|0.195
71018732|NCT00038467|141544941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.63|TWO_SIDED|95.0|-0.92|0.55|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.55|-0.92|0.630
71018733|NCT00038467|141544941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.53|TWO_SIDED|95.0|-0.5|0.98|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||0.98|-0.50|0.530
71018734|NCT00038467|141544941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.147|TWO_SIDED|95.0|-1.43|0.21|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.21|-1.43|0.147
71018735|NCT00038467|141544941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.389|TWO_SIDED|95.0|-1.18|0.46|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.46|-1.18|0.389
71018736|NCT00038467|141544943|SUPERIORITY_OR_OTHER|||||||0.0174|TWO_SIDED||||||Chi-squared|||6 months: p-value for percentage of participants with an endometrial thickness of \>=5 mm was analyzed using Chi-squared test.||||0.0174
71018737|NCT00038467|141544943|SUPERIORITY_OR_OTHER|||||||0.0059|TWO_SIDED||||||Chi-squared|||12 months: p-value for percentage of participants with an endometrial thickness of \>=5 mm was analyzed using Chi-squared test.||||0.0059
71018738|NCT00038467|141544943|SUPERIORITY_OR_OTHER|||||||0.0037|TWO_SIDED||||||Chi-squared|||24 months: p-value for percentage of participants with an endometrial thickness of \>=5 mm was analyzed using Chi-squared test.||||0.0037
71018739|NCT00038467|141544943|SUPERIORITY_OR_OTHER|||||||0.8084|TWO_SIDED||||||Chi-squared|||12 months post-treatment: p-value for percentage of participants with an endometrial thickness of \>=5 mm was analyzed using Chi-squared test.||||0.8084
71018740|NCT00038467|141544943|SUPERIORITY_OR_OTHER|||||||0.6449|TWO_SIDED||||||Chi-squared|||24 months post-treatment: p-value for percentage of participants with an endometrial thickness of \>=5 mm was analyzed using Chi-squared test.||||0.6449
71018741|NCT01988493|141544951|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|0.46||||0.0087|TWO_SIDED|90.0|0.28|0.76|||Log Rank|||||0.76|0.28|0.0087
71018742|NCT01988493|141544952|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|0.53||||0.0229||90.0|0.33|0.84|||Log Rank|||||0.84|0.33|0.0229
71018743|NCT01988493|141544953|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|0.71||||0.2333||90.0|0.45|1.14|||Log Rank|||||1.14|0.45|0.2333
71018744|NCT01988493|141544954|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|0.45||||0.0059||90.0|0.28|0.73|||Log Rank|||||0.73|0.28|0.0059
71052171|NCT00536263|141609319|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.011||||0.7|TWO_SIDED|95.0|-0.074|0.052|||Cochran-Mantel-Haenszel|Stratified by genotype||||0.052|-0.074|0.700
71052172|NCT00536263|141609319|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.054||||0.125|TWO_SIDED|95.0|-0.014|0.123|||Cochran-Mantel-Haenszel|Stratified by genotype||||0.123|-0.014|0.125
71052173|NCT00536263|141609319|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.065|||||TWO_SIDED|90.0|-0.122|-0.008||||||||-0.008|-0.122|
71052174|NCT00536263|141609320|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.016||||0.598|TWO_SIDED|95.0|-0.078|0.047|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.047|-0.078|0.598
71018745|NCT01988493|141544967|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|1.04||||0.8915||90.0|0.62|1.77|||Log Rank|||||1.77|0.62|0.8915
71018746|NCT01988493|141544968|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.||||||0.0438|||||||Cochran-Mantel-Haenszel|||||||0.0438
71018747|NCT01988493|141544970|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|0.59||||0.0496|TWO_SIDED|90.0|0.38|0.92|||Log Rank|||||0.92|0.38|0.0496
71018748|NCT01988493|141544971|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.||||||0.0527|||||||Cochran-Mantel-Haenszel|||||||0.0527
71018749|NCT01523301|141544973|SUPERIORITY_OR_OTHER||Difference in LS Mean|-1.12|||=|0.1286|TWO_SIDED|95.0|-2.56|0.33||The null hypothesis was assessed with a 2-sided test and not rejected at p≤0.05.|ANCOVA|||The change from Baseline to the end of the Maintenance period in the score of the HAM-D of rotigotine-treated subjects has been compared with those subjects on placebo in the EES. The null hypothesis (H0) was that there was no difference in the change of the HAM-D score between the active treatment and the placebo group. The alternative hypothesis (H1) was that there was a difference in the change of HAM-D score between the rotigotine and the placebo arm.||0.33|-2.56|=0.1286
71018750|NCT01447628|141544982|SUPERIORITY|||||||0.6039|||||||Mixed Models Analysis|||||||0.6039
71018751|NCT01447628|141544983|SUPERIORITY|||||||0.0747|||||||Mixed Models Analysis|||||||0.0747
71052175|NCT00536263|141609320|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.041||||0.24|TWO_SIDED|95.0|-0.027|0.108|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.108|-0.027|0.24
71052176|NCT00536263|141609320|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.056|||||TWO_SIDED|90.0|-0.112|-0.001||||||End of treatment||-0.001|-0.112|
71052177|NCT00536263|141609320|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.006||||0.83|TWO_SIDED|95.0|-0.075|0.063|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.063|-0.075|0.830
71052178|NCT00536263|141609320|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.13||||0.001|TWO_SIDED|95.0|0.053|0.208|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.208|0.053|0.001
70851251|NCT00669409|141190530|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.7|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-37.0|5.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.5|-37.0|
71018752|NCT01447628|141544983|SUPERIORITY|||||||0.799|||||||Mixed Models Analysis|||||||0.7990
71052179|NCT00536263|141609320|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.136||||||90.0|-0.201|-0.071||||||24 weeks after EOT||-0.071|-0.201|
71105786|NCT00402987|141718323|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.39||||0.633||95.0|-7.1|4.3||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||4.3|-7.1|0.633
71105787|NCT00402987|141718323|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.11||||0.284||95.0|-2.6|8.8||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||8.8|-2.6|0.284
71105788|NCT00402987|141718323|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.5||||0.18||95.0|-2.1|11.1||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||11.1|-2.1|0.180
71105789|NCT00402987|141718323|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.57||||0.009||95.0|3.4|23.7||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||23.7|3.4|0.009
71052180|NCT00536263|141609321|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.072||||0.076|TWO_SIDED|95.0|-0.007|0.151|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.151|-0.007|0.076
71052181|NCT00536263|141609321|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.135||||0.001|TWO_SIDED|95.0|0.053|0.216|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.216|0.053|0.001
71052182|NCT00536263|141609321|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.063|||||TWO_SIDED|90.0|-0.135|0.009||||||End of treatment||0.009|-0.135|
71052183|NCT00536263|141609321|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.017||||0.662|TWO_SIDED|95.0|-0.058|0.092|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.092|-0.058|0.662
71052184|NCT00536263|141609321|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.139|||<|0.001|TWO_SIDED|95.0|0.059|0.22|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.220|0.059|<0.001
71052185|NCT00536263|141609321|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.122|||||TWO_SIDED|90.0|-0.191|-0.053||||||24 weeks after EOT||-0.053|-0.191|
71052186|NCT00536263|141609322|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.019||||0.373|TWO_SIDED|95.0|-0.023|0.061|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.061|-0.023|0.373
71052187|NCT00536263|141609322|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.049||||0.04|TWO_SIDED|95.0|0.003|0.096|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.096|0.003|0.040
71052188|NCT00536263|141609322|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.03|||||TWO_SIDED|90.0|-0.072|0.011||||||End of treatment||0.011|-0.072|
71052189|NCT00536263|141609322|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.001||||0.969|TWO_SIDED|95.0|-0.041|0.043|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.043|-0.041|0.969
71052190|NCT00536263|141609322|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.045||||0.074|TWO_SIDED|95.0|-0.004|0.094|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.094|-0.004|0.074
71018753|NCT01447628|141544983|SUPERIORITY|||||||0.2111|||||||Mixed Models Analysis|||This is a combination of the p-values from the separate analyses of each data set.||||0.2111
71018754|NCT01447628|141544984|SUPERIORITY|||||||0.6583|||||||Mixed Models Analysis|||||||0.6583
71018755|NCT01447628|141544984|SUPERIORITY|||||||0.9166|||||||Mixed Models Analysis|||||||0.9166
71018756|NCT01447628|141544984|SUPERIORITY|||||||0.6631|||||||Mixed Models Analysis|||||||0.6631
71018757|NCT01447628|141544985|SUPERIORITY|||||||0.4039|||||||Mixed Models Analysis|||||||0.4039
71018758|NCT01447628|141544985|SUPERIORITY|||||||0.9144|||||||Mixed Models Analysis|||||||0.9144
71018759|NCT01447628|141544985|SUPERIORITY|||||||0.9959|||||||Mixed Models Analysis|||||||0.9959
71018760|NCT01447628|141544986|SUPERIORITY|||||||0.1788|||||||Mixed Models Analysis|||||||0.1788
71052191|NCT00536263|141609322|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.044|||||TWO_SIDED|90.0|-0.085|-0.003||||||24 weeks after EOT||-0.003|-0.085|
71052192|NCT00536263|141609323|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.004||||0.724|TWO_SIDED|95.0|-0.027|0.019|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.019|-0.027|0.724
71052193|NCT00536263|141609323|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.018||||0.243|TWO_SIDED|95.0|-0.012|0.048|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.048|-0.012|0.243
71052194|NCT00536263|141609323|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.022|||||TWO_SIDED|90.0|-0.046|0.002||||||End of treatment||0.002|-0.046|
71052195|NCT00536263|141609323|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.004||||0.724|TWO_SIDED|95.0|-0.027|0.019|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.019|-0.027|0.724
71052196|NCT00536263|141609323|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.018||||0.232|TWO_SIDED|95.0|-0.012|0.048|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.048|-0.012|0.232
71052197|NCT00536263|141609323|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.022|||||TWO_SIDED|90.0|-0.046|0.002||||||24 weeks after EOT||0.002|-0.046|
71052198|NCT00536263|141609324|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.056||||0.219|TWO_SIDED|95.0|-0.033|0.145|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.145|-0.033|0.219
71052199|NCT00536263|141609324|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.126||||0.006|TWO_SIDED|95.0|0.037|0.216|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.216|0.037|0.006
71052200|NCT00536263|141609324|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.071|||||TWO_SIDED|90.0|-0.148|0.006||||||End of treatment||0.006|-0.148|
71052201|NCT00536263|141609324|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.082||||0.067|TWO_SIDED|95.0|-0.004|0.168|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.168|-0.004|0.067
71052202|NCT00536263|141609324|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.18|||<|0.001|TWO_SIDED|95.0|0.092|0.268|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.268|0.092|<0.001
71018761|NCT01447628|141544986|SUPERIORITY|||||||0.7795|||||||Mixed Models Analysis|||||||0.7795
71018762|NCT01447628|141544986|SUPERIORITY|||||||0.414|||||||Mixed Models Analysis|||||||0.414
71018763|NCT01447628|141544987|SUPERIORITY|||||||0.8688|||||||Mixed Models Analysis|||||||0.8688
71018764|NCT01447628|141544987|SUPERIORITY|||||||0.9999|||||||Mixed Models Analysis|||||||0.9999
71018765|NCT01447628|141544987|SUPERIORITY|||||||0.991|||||||Mixed Models Analysis|||||||0.991
71018766|NCT01447628|141544988|SUPERIORITY|||||||0.5465|||||||Mixed Models Analysis|||||||0.5465
71018767|NCT01447628|141544988|SUPERIORITY|||||||0.4298|||||||Mixed Models Analysis|||||||0.4298
71018768|NCT01447628|141544988|SUPERIORITY|||||||0.5451|||||||Mixed Models Analysis|||||||0.5451
71018769|NCT01447628|141544989|SUPERIORITY|||||||0.6241|||||||Mixed Models Analysis|||Note that Endurance CPET was not done in China, hence only European data provided.||||0.6241
71018770|NCT01447628|141544990|SUPERIORITY|||||||0.4758|||||||Mixed Models Analysis|||||||0.4758
70932060|NCT02307682|141364347|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-5.2|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||4.6|-5.2|
71018771|NCT01447628|141544991|SUPERIORITY|||||||0.205|||||||Mixed Models Analysis|||||||0.2050
71018772|NCT01447628|141544991|SUPERIORITY|||||||0.1993|||||||Mixed Models Analysis|||||||0.1993
71018773|NCT01447628|141544991|SUPERIORITY|||||||0.1993|||||||Mixed Models Analysis|||||||0.1993
71018774|NCT01447628|141544992|SUPERIORITY|||||||0.061|||||||Mixed Models Analysis|||||||0.0610
71018775|NCT01447628|141544992|SUPERIORITY|||||||0.0641|||||||Mixed Models Analysis|||||||0.0641
71018776|NCT01447628|141544993|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|||||||0.0003
71018777|NCT01447628|141544993|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||||||0.0001
71018778|NCT01447628|141544993|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71018779|NCT01447628|141544994|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71018780|NCT01447628|141544995|SUPERIORITY|||||||0.8093|||||||Mixed Models Analysis|||||||0.8093
71018781|NCT01447628|141544995|SUPERIORITY|||||||0.63|||||||Mixed Models Analysis|||||||0.6300
71018782|NCT01447628|141544995|SUPERIORITY|||||||0.8533|||||||Mixed Models Analysis|||||||0.8533
71018783|NCT01447628|141544996|SUPERIORITY|||||||0.0725|||||||Mixed Models Analysis|||||||0.0725
71018784|NCT01447628|141544996|SUPERIORITY|||||||0.8572|||||||Mixed Models Analysis|||||||0.8572
71018785|NCT01447628|141544996|SUPERIORITY|||||||0.2348|||||||Mixed Models Analysis|||||||0.2348
71018786|NCT01447628|141544997|SUPERIORITY|||||||0.1115|||||||Mixed Models Analysis|||||||0.1115
71018787|NCT01447628|141544998|SUPERIORITY|||||||0.979|||||||Mixed Models Analysis|||||||0.9790
71018788|NCT01447628|141544999|SUPERIORITY|||||||0.7702|||||||Mixed Models Analysis|||||||0.7702
71018789|NCT01447628|141545000|SUPERIORITY|||||||0.2219|||||||Mixed Models Analysis|||||||0.2219
71018790|NCT01447628|141545001|SUPERIORITY|||||||0.1777|||||||Mixed Models Analysis|||||||0.1777
71018791|NCT01447628|141545001|SUPERIORITY|||||||0.7889|||||||Mixed Models Analysis|||||||0.7889
71018792|NCT01447628|141545001|SUPERIORITY|||||||0.4156|||||||Mixed Models Analysis|||||||0.4156
71018793|NCT01447628|141545002|SUPERIORITY|||||||0.7625|||||||Mixed Models Analysis|||||||0.7625
71018794|NCT01447628|141545002|SUPERIORITY|||||||0.2262|||||||Mixed Models Analysis|||||||0.2262
71018795|NCT01447628|141545002|SUPERIORITY|||||||0.4756|||||||Mixed Models Analysis|||||||0.4756
71018796|NCT01447628|141545003|SUPERIORITY|||||||0.7711|||||||Mixed Models Analysis|||||||0.7711
71018797|NCT01447628|141545003|SUPERIORITY|||||||0.7806|||||||Mixed Models Analysis|||||||0.7806
71018798|NCT01447628|141545003|SUPERIORITY|||||||0.9074|||||||Mixed Models Analysis|||||||0.9074
71018799|NCT01447628|141545004|SUPERIORITY|||||||0.9504|||||||Mixed Models Analysis|||||||0.9504
71018800|NCT01447628|141545004|SUPERIORITY|||||||0.8666|||||||Mixed Models Analysis|||||||0.8666
71018801|NCT01447628|141545004|SUPERIORITY|||||||0.8104|||||||Mixed Models Analysis|||||||0.8104
71018802|NCT01447628|141545005|SUPERIORITY|||||||0.4478|||||||Mixed Models Analysis|||||||0.4478
71018803|NCT01447628|141545006|SUPERIORITY|||||||0.459|||||||Mixed Models Analysis|||||||0.4590
71018804|NCT01447628|141545007|SUPERIORITY|||||||0.8086|||||||Mixed Models Analysis|||||||0.8086
71018805|NCT01447628|141545008|SUPERIORITY|||||||0.6944|||||||Mixed Models Analysis|||||||0.6944
71018806|NCT01447628|141545009|SUPERIORITY|||||||0.585|||||||Mixed Models Analysis|||||||0.585
71018807|NCT01447628|141545010|SUPERIORITY|||||||0.4619|||||||Mixed Models Analysis|||||||0.4619
71018808|NCT01447628|141545011|SUPERIORITY|||||||0.7721|||||||Mixed Models Analysis|||||||0.7721
71018809|NCT01447628|141545012|SUPERIORITY|||||||0.8332|||||||Mixed Models Analysis|||||||0.8332
71018810|NCT01447628|141545013|SUPERIORITY|||||||0.2651|||||||Mixed Models Analysis|||||||0.2651
71018811|NCT00639158|141545023|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The treatment group comparisons for both primary efficacy variables must have demonstrated superiority of ABT-335 + atorvastatin + ezetimibe to declare this arm successful. Thus, no adjustments were made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||A sample size of 212 per arm provided 90% power and \> 99% power with a 2-sided alpha = 0.05 level to detect differences between treatment arms of 6% and 17% in the percent change in HDL-C and TG, respectively, assuming an SD of 19% and 30%, respectively. This sample size provided an overall power of approximately 90% for the 2 primary comparisons. If a loss to follow-up rate of 8% was assumed, the sample size needed to be increased to 230 per arm to maintain the above power.||||< 0.001
71018812|NCT00639158|141545024|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANCOVA|Corresponding baseline lipid value as the covariate and with effect for treatment group.||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.||||0.004
71052203|NCT00536263|141609324|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.098|||||TWO_SIDED|90.0|-0.174|-0.021||||||24 weeks after EOT||-0.021|-0.174|
71052204|NCT00536263|141609325|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.001||||0.995|TWO_SIDED|95.0|-0.039|0.041|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.041|-0.039|0.995
71052205|NCT00536263|141609325|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.054||||0.031|TWO_SIDED|95.0|0.005|0.103|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.103|0.005|0.031
71105790|NCT00402987|141718323|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.15||||0.026||95.0|1.7|26.6||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||26.6|1.7|0.026
71105791|NCT00402987|141718323|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.39||||0.138||95.0|-3.0|21.8||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||21.8|-3.0|0.138
71105792|NCT00402987|141718323|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59||||0.926||95.0|-13.0|11.8||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||11.8|-13.0|0.926
71105793|NCT00402987|141718323|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.18||||0.507||95.0|-8.2|16.6||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||16.6|-8.2|0.507
70851252|NCT00669409|141190531|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|9.0|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-7.4|25.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||25.5|-7.4|
71018813|NCT00639158|141545025|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The treatment group comparisons for both primary efficacy variables must have demonstrated superiority of ABT-335 + atorvastatin + ezetimibe to declare this arm successful. Thus, no adjustments were made for multiple comparisons.|ANCOVA|Corresponding baseline lipid value as the covariate and with effect for treatment group.||A sample size of 212 per arm provided 90% power and \> 99% power with a 2-sided alpha = 0.05 level to detect differences between treatment arms of 6% and 17% in the percent change in HDL-C and TG, respectively, assuming an SD of 19% and 30%, respectively. This sample size provided an overall power of approximately 90% for the 2 primary comparisons. If a loss to follow-up rate of 8% was assumed, the sample size needed to be increased to 230 per arm to maintain the above power.||||< 0.001
71018814|NCT00639158|141545026|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Corresponding baseline lipid value as the covariate and with effect for treatment group.||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.||||< 0.001
71018815|NCT00639158|141545027|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Corresponding lipid value as the covariate and with effect for treatment group.||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.||||< 0.001
71052206|NCT00536263|141609325|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.053|||||TWO_SIDED|90.0|-0.094|-0.012||||||End of treatment||-0.012|-0.094|
71052207|NCT00536263|141609325|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.024||||0.389|TWO_SIDED|95.0|-0.03|0.078|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.078|-0.030|0.389
71105794|NCT00402987|141718323|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.77||||0.513||95.0|-9.6|19.1||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||19.1|-9.6|0.513
71105795|NCT00402987|141718324|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.93||||0.023||95.0|1.2|7.4|||Regression, Logistic|Treatment as a factor||||7.4|1.2|0.023
71105796|NCT00402987|141718324|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.13||||0.015||95.0|1.2|7.9|||Regression, Logistic|Treatment as a factor||||7.9|1.2|0.015
71052208|NCT00536263|141609325|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.121|||<|0.001|TWO_SIDED|95.0|0.058|0.184|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.184|0.058|<0.001
71052209|NCT00536263|141609325|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.097|||||TWO_SIDED|90.0|-0.152|-0.041||||||24 weeks after EOT||-0.041|-0.152|
71052210|NCT00536263|141609326|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.0||||0.991|TWO_SIDED|95.0|-0.012|0.012|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.012|-0.012|0.991
71105797|NCT00402987|141718324|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.07||||0.854||95.0|0.5|2.2|||Regression, Logistic|Treatment as a factor||||2.2|0.5|0.854
71105798|NCT00402987|141718325|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.46||||0.013||95.0|1.3|9.2|||Regression, Logistic|Treatment as a factor||||9.2|1.3|0.013
71105799|NCT00402987|141718325|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.03||||0.003||95.0|1.7|14.5|||Regression, Logistic|Treatment as a factor||||14.5|1.7|0.003
71105800|NCT00402987|141718325|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.99||||0.057||95.0|1.0|9.2|||Regression, Logistic|Treatment as a factor||||9.2|1.0|0.057
71105801|NCT00402987|141718325|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.758||95.0|0.5|2.9|||Regression, Logistic|Treatment as a factor||||2.9|0.5|0.758
71105802|NCT00402987|141718325|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.69||||0.381||95.0|0.3|1.6|||Regression, Logistic|Treatment as a factor||||1.6|0.3|0.381
71105803|NCT00402987|141718325|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.68||||0.313||95.0|0.6|4.6|||Regression, Logistic|Treatment as a factor||||4.6|0.6|0.313
71105804|NCT00402987|141718326|SUPERIORITY_OR_OTHER_LEGACY||NNT at 6 hours|8.2||||||95.0|4.5|46.4||||||NNT is the inverse of the absolute risk reduction at 6 hours||46.4|4.5|
71105805|NCT00402987|141718326|SUPERIORITY_OR_OTHER_LEGACY||NNT at 6 hours|7.5||||||95.0|4.3|32.0||||||NNT is the inverse of the absolute risk reduction at 6 hours||32.0|4.3|
71052211|NCT00536263|141609326|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.013||||0.181|TWO_SIDED|95.0|-0.006|0.033|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.033|-0.006|0.181
71052212|NCT00536263|141609326|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.013|||||TWO_SIDED|90.0|-0.03|0.003||||||End of treatment||0.003|-0.030|
71018816|NCT00639158|141545028|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Corresponding baseline lipid value as the covariate and with effect for treatment group.||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.||||< 0.001
71018817|NCT00639158|141545029|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Corresponding baseline lipid value as the covariate and with effect for treatment group.||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.||||< 0.001
71052213|NCT00536263|141609326|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.0||||0.971|TWO_SIDED|95.0|-0.012|0.012|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.012|-0.012|0.971
71052214|NCT00536263|141609326|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.013||||0.179|TWO_SIDED|95.0|-0.006|0.033|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.033|-0.006|0.179
71052215|NCT00536263|141609326|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.013|||||TWO_SIDED|90.0|-0.03|0.003||||||24 weeks after EOT||0.003|-0.030|
71052216|NCT00536263|141609327|SUPERIORITY_OR_OTHER|||||||0.991|||||||Cochran-Mantel-Haenszel|"Stratified by genotype~Due to zero responses in the 2 arms, pairwise rate difference \& corresponding 95% confidence interval were not applicable."||End of treatment||||0.991
71052217|NCT00536263|141609327|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.004||||0.322|TWO_SIDED|95.0|-0.004|0.013|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.013|-0.004|0.322
71052218|NCT00536263|141609327|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.004|||||TWO_SIDED|90.0|-0.012|0.003||||||End of treatment||0.003|-0.012|
71052219|NCT00536263|141609327|SUPERIORITY_OR_OTHER|||||||0.991||95.0|||||Cochran-Mantel-Haenszel|"Stratified by genotype~Due to zero responses in the 2 arms, pairwise rate difference \& corresponding 95% confidence interval were not applicable."||24 weeks after EOT||||0.991
71052220|NCT00536263|141609327|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.009||||0.157|TWO_SIDED|95.0|-0.003|0.021|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.021|-0.003|0.157
71052221|NCT00536263|141609327|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.009|||||TWO_SIDED|90.0|-0.019|0.001||||||24 weeks after EOT||0.001|-0.019|
71052222|NCT00536263|141609328|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||t-test, 2 sided|comparison of post-treatment versus baseline values||||||0.014
71052223|NCT00536263|141609328|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|comparison of post-treatment versus baseline values||||||<0.001
71052224|NCT00536263|141609328|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|comparison of post-treatment versus baseline values||||||0.010
71052225|NCT00536263|141609328|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.2||||0.631|TWO_SIDED|95.0|-1.2|0.8|||ANCOVA|Treatment group and genotype were the fixed effects and baseline was the covariate.||||0.8|-1.2|0.631
71052226|NCT00536263|141609328|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.3||||0.617|TWO_SIDED|95.0|-1.4|0.8|||ANCOVA|Treatment group and genotype were the fixed effects and baseline was the covariate.||||0.8|-1.4|0.617
71052227|NCT00536263|141609328|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||||1.1|-1.1|
71052228|NCT03118570|141609377|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.644||||||Analysis is based on a log transformed analysis of covariance (ANCOVA) model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.644
71052229|NCT03118570|141609377|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.485||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.485
71052230|NCT03118570|141609377|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.404||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.404
71052231|NCT03118570|141609378|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.006||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.006
71052232|NCT03118570|141609378|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.19||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.190
71052233|NCT03118570|141609378|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.704||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.704
71052234|NCT03118570|141609379|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.011||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.011
71018818|NCT00639158|141545030|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|Rank-sum test||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.||||< 0.001
71052235|NCT03118570|141609379|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.047||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.047
71052236|NCT03118570|141609379|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.756||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.756
71052237|NCT03118570|141609380|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.329||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.329
71052238|NCT03118570|141609380|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.953||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.953
71052239|NCT03118570|141609380|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.795||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.795
71052240|NCT03118570|141609380|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.644||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.644
71052241|NCT03118570|141609380|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.485||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.485
71018819|NCT01787188|141545039|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.84|STANDARD_ERROR_OF_MEAN|3.097||0.0005|TWO_SIDED|95.0|-16.93|-4.75|||Mixed Models Analysis|||||-4.75|-16.93|0.0005
71018820|NCT01787188|141545039|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-8.74|STANDARD_ERROR_OF_MEAN|3.154||0.0059|TWO_SIDED|95.0|-14.94|-2.53|||Mixed Models Analysis|||||-2.53|-14.94|0.0059
71018821|NCT01787188|141545040|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.61|STANDARD_ERROR_OF_MEAN|2.641||0.0003|TWO_SIDED|95.0|-14.8|-4.42|||Mixed Models Analysis|||||-4.42|-14.80|0.0003
71018822|NCT01787188|141545040|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-3.9|STANDARD_ERROR_OF_MEAN|2.696||0.1486|TWO_SIDED|95.0|-9.2|1.4|||Mixed Models Analysis|||||1.40|-9.20|0.1486
71018823|NCT01787188|141545041|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.33|STANDARD_ERROR_OF_MEAN|2.865||0.0004|TWO_SIDED|95.0|-15.97|-4.7|||Mixed Models Analysis|||||-4.70|-15.97|0.0004
71018824|NCT01787188|141545041|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.84|STANDARD_ERROR_OF_MEAN|2.917||0.0008|TWO_SIDED|95.0|-15.58|-4.1|||Mixed Models Analysis|||||-4.10|-15.58|0.0008
71018825|NCT01787188|141545042|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.44|STANDARD_ERROR_OF_MEAN|2.521|<|0.0001|TWO_SIDED|95.0|-15.4|-5.48|||ANCOVA|||||-5.48|-15.40|<0.0001
71018826|NCT01787188|141545042|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-7.82|STANDARD_ERROR_OF_MEAN|2.561||0.0024|TWO_SIDED|95.0|-12.85|-2.78|||ANCOVA|||||-2.78|-12.85|0.0024
71018827|NCT01787188|141545043|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.34|STANDARD_ERROR_OF_MEAN|2.623|<|0.0001|TWO_SIDED|95.0|-15.49|-5.18|||Mixed Models Analysis|||||-5.18|-15.49|<0.0001
71018828|NCT01787188|141545043|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-4.39|STANDARD_ERROR_OF_MEAN|2.662||0.0997|TWO_SIDED|95.0|-9.63|0.84|||Mixed Models Analysis|||||0.84|-9.63|0.0997
71018829|NCT01787188|141545044|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.83|STANDARD_ERROR_OF_MEAN|2.905||0.0008|TWO_SIDED|95.0|-15.54|-4.11|||Mixed Models Analysis|||||-4.11|-15.54|0.0008
71018830|NCT01787188|141545044|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.42|STANDARD_ERROR_OF_MEAN|2.951||0.0015|TWO_SIDED|95.0|-15.22|-3.62|||Mixed Models Analysis|||||-3.62|-15.22|0.0015
71018831|NCT01787188|141545045|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.13|STANDARD_ERROR_OF_MEAN|3.147||0.0014|TWO_SIDED|95.0|-16.32|-3.94|||Mixed Models Analysis|||||-3.94|-16.32|0.0014
71018832|NCT01787188|141545045|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.98|STANDARD_ERROR_OF_MEAN|3.198||0.0019|TWO_SIDED|95.0|-16.27|-3.69|||Mixed Models Analysis|||||-3.69|-16.27|0.0019
71018833|NCT01787188|141545046|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.47|STANDARD_ERROR_OF_MEAN|2.593|<|0.0001|TWO_SIDED|95.0|-15.57|-5.37|||ANCOVA|||||-5.37|-15.57|<0.0001
71052242|NCT03118570|141609380|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.404||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.404
71052243|NCT03118570|141609380|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.827||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.827
71052244|NCT03118570|141609380|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.459||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.459
71105806|NCT00402987|141718327|SUPERIORITY_OR_OTHER_LEGACY||NNT at 12 hours|7.5||||||95.0|4.3|28.7||||||NNT is the inverse of the absolute risk reduction at 12 hours||28.7|4.3|
71018834|NCT01787188|141545046|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-8.16|STANDARD_ERROR_OF_MEAN|2.627||0.002|TWO_SIDED|95.0|-13.33|-2.99|||ANCOVA|||||-2.99|-13.33|0.0020
71018835|NCT01787188|141545047|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.45|STANDARD_ERROR_OF_MEAN|2.686||0.0001|TWO_SIDED|95.0|-15.73|-5.17|||Mixed Models Analysis|||||-5.17|-15.73|0.0001
71018836|NCT01787188|141545047|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-4.41|STANDARD_ERROR_OF_MEAN|2.725||0.1065|TWO_SIDED|95.0|-9.77|0.95|||Mixed Models Analysis|||||0.95|-9.77|0.1065
71018837|NCT01787188|141545048|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.68|STANDARD_ERROR_OF_MEAN|2.961||0.0012|TWO_SIDED|95.0|-15.5|-3.85|||Mixed Models Analysis|||||-3.85|-15.50|0.0012
71018838|NCT01787188|141545048|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.65|STANDARD_ERROR_OF_MEAN|3.006||0.0014|TWO_SIDED|95.0|-15.56|-3.74|||Mixed Models Analysis|||||-3.74|-15.56|0.0014
71018839|NCT01787188|141545049|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.26|STANDARD_ERROR_OF_MEAN|3.194||0.0014|TWO_SIDED|95.0|-16.54|-3.97|||Mixed Models Analysis|||||-3.97|-16.54|0.0014
71018840|NCT01787188|141545049|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.45|STANDARD_ERROR_OF_MEAN|3.24||0.0014|TWO_SIDED|95.0|-16.82|-4.08|||Mixed Models Analysis|||||-4.08|-16.82|0.0014
71052245|NCT03118570|141609380|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.022||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.022
71052246|NCT03118570|141609380|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.821||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.821
71052247|NCT03118570|141609380|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.911||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.911
71052248|NCT03118570|141609380|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.152||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.152
71052249|NCT03118570|141609380|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.668||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.668
71052250|NCT03118570|141609380|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.109||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.109
71052251|NCT03118570|141609380|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.358||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.358
71052252|NCT03118570|141609380|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.742||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.742
71052253|NCT03118570|141609380|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.567||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.567
71052254|NCT03118570|141609380|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.43||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.430
71052255|NCT03118570|141609380|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.634||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.634
71052256|NCT03118570|141609380|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.146||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.146
71052257|NCT03118570|141609380|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.521||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.521
71052258|NCT03118570|141609380|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.991||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.991
71105807|NCT00402987|141718327|SUPERIORITY_OR_OTHER_LEGACY||NNT at 12 hours|5.0||||||95.0|3.0|16.7||||||NNT is the inverse of the absolute risk reduction at 12 hours||16.7|3.0|
71105808|NCT00402987|141718328|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.77|||<|0.001||95.0|1.9|7.6||Analysis for 2 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||7.6|1.9|<0.001
71018841|NCT01787188|141545050|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.52|STANDARD_ERROR_OF_MEAN|2.646|<|0.0001|TWO_SIDED|95.0|-15.72|-5.31|||ANCOVA|||||-5.31|-15.72|<0.0001
71105809|NCT00402987|141718328|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.72||||0.005||95.0|1.3|5.5||Analysis for 2 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||5.5|1.3|0.005
71018842|NCT01787188|141545050|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-8.44|STANDARD_ERROR_OF_MEAN|2.68||0.0018|TWO_SIDED|95.0|-13.71|-3.17|||ANCOVA|||||-3.17|-13.71|0.0018
71018843|NCT01787188|141545051|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.98|STANDARD_ERROR_OF_MEAN|2.831||0.0001|TWO_SIDED|95.0|-16.55|-5.41|||Mixed Models Analysis|||||-5.41|-16.55|0.0001
71018844|NCT01787188|141545051|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-6.02|STANDARD_ERROR_OF_MEAN|2.89||0.0379|TWO_SIDED|95.0|-11.71|-0.34|||Mixed Models Analysis|||||-0.34|-11.71|0.0379
71018845|NCT01787188|141545052|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-12.22|STANDARD_ERROR_OF_MEAN|3.152||0.0001|TWO_SIDED|95.0|-18.42|-6.02|||Mixed Models Analysis|||||-6.02|-18.42|0.0001
71018846|NCT01787188|141545052|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.1|STANDARD_ERROR_OF_MEAN|3.21||0.0049|TWO_SIDED|95.0|-15.41|-2.78|||Mixed Models Analysis|||||-2.78|-15.41|0.0049
71018847|NCT01787188|141545053|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.94|STANDARD_ERROR_OF_MEAN|3.359||0.0012|TWO_SIDED|95.0|-17.55|-4.33|||Mixed Models Analysis|||||-4.33|-17.55|0.0012
71018848|NCT01787188|141545053|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.36|STANDARD_ERROR_OF_MEAN|3.422||0.0066|TWO_SIDED|95.0|-16.09|-2.63|||Mixed Models Analysis|||||-2.63|-16.09|0.0066
71018849|NCT01787188|141545054|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-11.67|STANDARD_ERROR_OF_MEAN|2.751|<|0.0001|TWO_SIDED|95.0|-17.08|-6.26|||ANCOVA|||||-6.26|-17.08|<0.0001
71018850|NCT01787188|141545054|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-8.24|STANDARD_ERROR_OF_MEAN|2.795||0.0034|TWO_SIDED|95.0|-13.74|-2.74|||ANCOVA|||||-2.74|-13.74|0.0034
71052259|NCT03118570|141609380|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.069||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.069
71052260|NCT03118570|141609380|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.625||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.625
71018851|NCT02617446|141545066|SUPERIORITY||Mean Difference (Final Values)|-3.0||||0.029|TWO_SIDED|95.0|-5.68|-0.32||Alpha set at 0.05.|ANOVA|Treatment term included in the model||Null hypothesis: No difference in E/Ea ratio between istaroxime and placebo||-0.32|-5.68|0.029
71018852|NCT02617446|141545066|SUPERIORITY||Mean Difference (Final Values)|-2.08||||0.009|TWO_SIDED|95.0|-3.61|-0.55||Alpha set at 0.05.|ANOVA|Treatment term included in the model||Null hypothesis: No difference in E/Ea ratio between istaroxime and placebo||-0.55|-3.61|0.009
71018853|NCT02617446|141545067|SUPERIORITY||Mean Difference (Final Values)|1.7632||||0.089|TWO_SIDED|95.0|-0.2751|3.8014||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term included in the model||Null hypothesis: No difference in LVEF % between istaroxime and placebo participants.||3.8014|-0.2751|0.089
71018854|NCT02617446|141545067|SUPERIORITY||Mean Difference (Final Values)|0.9848||||0.423|TWO_SIDED|95.0|-1.4668|3.4365||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term included in the model||Null hypothesis: No difference in LVEF % between istaroxime and placebo participants.||3.4365|-1.4668|0.423
71018855|NCT02617446|141545068|SUPERIORITY||Mean Difference (Final Values)|3.684||||0.034|TWO_SIDED|95.0|0.285|7.083||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is in the model.||Null hypothesis: No difference in SVI between istaroxime and placebo participants.||7.083|0.285|0.034
71018856|NCT02617446|141545068|SUPERIORITY||Mean Difference (Final Values)|2.31||||0.09|TWO_SIDED|95.0|-0.373|4.992||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is in the model||Null hypothesis: No difference in E to A ratio between istaroxime and placebo participants.||4.992|-0.373|0.090
71018857|NCT02617446|141545069|SUPERIORITY||Mean Difference (Final Values)|-0.777||||0.042|TWO_SIDED|95.0|-1.522|-0.032||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is included in the model||Null hypothesis: No difference in E to A ratio between istaroxime and placebo participants.||-0.032|-1.522|0.042
71018858|NCT02617446|141545069|SUPERIORITY||Mean Difference (Final Values)|-0.829||||0.029|TWO_SIDED|95.0|-1.568|-0.091||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is in the model||Null hypothesis: No difference in E to A ratio between istaroxime and placebo participants.||-0.091|-1.568|0.029
71018859|NCT02617446|141545070|SUPERIORITY||Mean Difference (Final Values)|-5.368||||0.11|TWO_SIDED|95.0|-11.999|1.262||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is in the model||Null hypothesis: No difference in LVESV between istaroxime and placebo participants.||1.262|-11.999|0.110
71018860|NCT02617446|141545070|SUPERIORITY||Mean Difference (Final Values)|0.439||||0.931|TWO_SIDED|95.0|-9.735|10.614||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is in the model||Null hypothesis: No difference in LVEDV between istaroxime and placebo participants.||10.614|-9.735|0.931
71018861|NCT02617446|141545071|SUPERIORITY||Mean Difference (Final Values)|-1.657||||0.589|TWO_SIDED|95.0|-7.777|4.461||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term in the model||Null hypothesis: No difference in E to A ratio between istaroxime and placebo participants.||4.461|-7.777|0.589
71018862|NCT02617446|141545071|SUPERIORITY||Mean Difference (Final Values)|3.944||||0.424|TWO_SIDED|95.0|-5.886|13.774||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is in the model.||Null hypothesis: No difference in E to A ratio between istaroxime and placebo participants.||13.774|-5.886|0.424
71018863|NCT02617446|141545072|SUPERIORITY|Linear mixed model with treatment, center, timepoint, gender, baseline cTnT value, atrial fibrillation, and treatment\*timepoint interaction included in the model.|Mean Difference (Final Values)|-0.041||||0.987|TWO_SIDED|95.0|-5.216|5.133||Unadjusted alpha of 0.05 is the threshold for statistical significance.|Mixed Models Analysis|Kenward-Roger adjustment used for the degrees of freedom.||Null hypothesis: no difference between treatment groups||5.133|-5.216|0.987
71052261|NCT03118570|141609381|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.615||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.615
71105810|NCT00402987|141718328|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.72||||0.286||95.0|0.4|1.3||Analysis for 2 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||1.3|0.4|0.286
70932061|NCT02307682|141364347|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-5.5|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||4.1|-5.5|
71018864|NCT02617446|141545072|SUPERIORITY|Linear mixed model with treatment, center, timepoint, gender, baseline cTnT value, atrial fibrillation, and treatment\*timepoint interaction included in the model.|Mean Difference (Final Values)|3.015||||0.251|TWO_SIDED|95.0|-2.168|8.198||Unadjusted alpha of 0.05 is the threshold for statistical significance.|Mixed Models Analysis|Kenward-Roger adjustment used for the degrees of freedom.||Null hypothesis: no difference between treatment groups.||8.198|-2.168|0.251
71052262|NCT03118570|141609381|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.376||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.376
71052263|NCT03118570|141609381|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.259||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.259
71018865|NCT00865306|141545112|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|||||||<.05
71018866|NCT00865306|141545113|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Chi-squared|||||||<.01
71018867|NCT00929864|141545130|NON_INFERIORITY_OR_EQUIVALENCE|Analysis tested for non-inferiority. Abatacept will be considered non-inferior to adalimumab if the upper limit of the 95% two-sided CI of difference in ACR20 response rates between the adalimumab arm and the abatacept arm is smaller than or equal to 12%. Estimate and 95% confidence interval (CI) for difference based on minimum risk weights method with randomization stratification of screening Disease Activity Score-28 (DAS28) c-reactive protein (CRP).|Difference from adalimumab at Day 365|1.8|||||TWO_SIDED|95.0|-5.6|9.2|||minimum risk weights method|adjusted for randomization stratification of screening Disease Activity Score-28 (DAS28) c-reactive protein (CRP).||The null and alternative hypotheses are H0: T - C\<= δ vs. Ha:T - C \> δ, where T is the treatment effect of abatacept, C is the effect of active control (adalimumab),and δ is non-inferiority margin. Abatacept is defined as δ non-inferior to adalimumab when H0 is rejected. More specifically, if the lower bound of the 95% two-sided confidence interval for C-T is greater than δ,, then that Abatacept is δ non-inferior to adalimumab can be claimed.||9.2|-5.6|
71018868|NCT00929864|141545131|SUPERIORITY_OR_OTHER||Difference in proportions|-5.37||||0.006|TWO_SIDED|95.0|-9.13|-1.62|||Chi-squared|||Analysis is p-value of difference in proportions. n=number of participants with event, N=number of participants at risk. Proportion = n/N. In order to maintain the overall type I error rate of 0.05 for testing both the primary non-inferiority hypothesis and the key secondary local injection site reaction (LISR) hypothesis, the LISR hypothesis was tested at the 5% significance level only after the primary non-inferiority hypothesis is established at the 5% level.||-1.62|-9.13|0.006
71018869|NCT00929864|141545132|SUPERIORITY_OR_OTHER||Difference from adalimumab|-4.13|||||TWO_SIDED|95.0|-6.55|-1.72||||||Analysis of incidence rate at 24 months. Point estimate and 95% CI. Poisson distribution was used to construct the 95% CIs.||-1.72|-6.55|
71018870|NCT00929864|141545133|SUPERIORITY_OR_OTHER||Difference from adalimumab at Day 365|-1.3|||||TWO_SIDED|95.0|-6.5|3.9|||minimum risk weights method|Adjusted for randomization stratification of screening Disease Activity Score-28 (DAS28) c-reactive protein (CRP).||This analysis is for Day 365.||3.9|-6.5|
71052264|NCT03118570|141609381|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.253||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.253
71052265|NCT03118570|141609382|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.064||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.064
71018871|NCT00929864|141545133|SUPERIORITY_OR_OTHER||Difference from adalimumab at Day 729|0.9|||||TWO_SIDED|95.0|-5.5|7.3|||minimum risk weights method|Adjusted for randomization stratification of screening Disease Activity Score-28 (DAS28) c-reactive protein (CRP).||This analysis is for Day 729.||7.3|-5.5|
71018872|NCT00929864|141545134|SUPERIORITY_OR_OTHER||Difference from adalimumab|0.8|||||TWO_SIDED|95.0|-4.51|6.11||||||Analysis for incidence rate of SAE at 12 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||6.11|-4.51|
71018873|NCT00929864|141545134|SUPERIORITY_OR_OTHER||Difference from adalimumab|-0.67|||||TWO_SIDED|95.0|-3.27|1.94||||||Analysis for incidence rate of Serious Infections and Infestations at 12 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||1.94|-3.27|
71018874|NCT00929864|141545134|SUPERIORITY_OR_OTHER||Difference from adalimumab|0.0|||||TWO_SIDED|95.0|-0.92|0.91||||||Analysis for incidence rate of Opportunistic Infections at 12 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||0.91|-0.92|
71018875|NCT00929864|141545134|SUPERIORITY_OR_OTHER||Difference from adalimumab|-5.32|||||TWO_SIDED|95.0|-12.06|1.41||||||Analysis for incidence rate of discontinuation for any cause at 12 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||1.41|-12.06|
71052266|NCT03118570|141609382|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.019||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.019
71052267|NCT03118570|141609382|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.845||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.845
71052268|NCT03118570|141609382|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.006||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.006
71018876|NCT00929864|141545135|SUPERIORITY_OR_OTHER||Difference from adalimumab|-1.91|||||TWO_SIDED|95.0|-5.43|1.61||||||Analysis for incidence rate of SAE at 24 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||1.61|-5.43|
71018877|NCT00929864|141545135|SUPERIORITY_OR_OTHER||Difference from adalimumab|-1.24|||||TWO_SIDED|95.0|-3.12|0.63||||||Analysis for incidence rate of Serious infections and infestations Adverse Events at 24 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||0.63|-3.12|
71018878|NCT00929864|141545135|SUPERIORITY_OR_OTHER||Difference from adalimumab|-0.52|||||TWO_SIDED|95.0|-1.39|0.36|||minimum risk weights method|||Analysis for incidence rate of opportunistic infections at 24 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||0.36|-1.39|
71018879|NCT00929864|141545135|SUPERIORITY_OR_OTHER||Difference from adalimumab|-3.1|||||TWO_SIDED|95.0|-7.13|0.92||||||Analysis for incidence rate of discontinuations (all cause) at 24 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||0.92|-7.13|
71018880|NCT00929864|141545136|SUPERIORITY_OR_OTHER||Difference from adalimumab|-8.1|||||TWO_SIDED|95.0|-13.9|-2.2||||||Analysis for ANA at Day 365. Point estimate and 95% CI for treatment difference.||-2.2|-13.9|
71018881|NCT00929864|141545136|SUPERIORITY_OR_OTHER||Difference from adalimumab|-8.4|||||TWO_SIDED|95.0|-15.3|-1.5||||||Analysis for ANA at Day 729. Point estimate and 95% CI for treatment difference||-1.5|-15.3|
71018882|NCT00929864|141545136|SUPERIORITY_OR_OTHER||Difference from adalimumab|-9.6|||||TWO_SIDED|95.0|-13.4|-5.7||||||Analysis for dsDNA at Day 365. Point estimate and 95% CI for treatment difference.||-5.7|-13.4|
71018883|NCT00929864|141545136|SUPERIORITY_OR_OTHER||Difference from adalimumab|-12.2|||||TWO_SIDED|95.0|-16.9|-7.6||||||Analysis for dsDNA at Day 729. Point estimate and 95% CI for treatment difference.||-7.6|-16.9|
71018884|NCT03985293|141545163|SUPERIORITY||Difference in LS Mean|-0.47||||0.0071|TWO_SIDED|90.0|-0.76|-0.18|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.18|-0.76|0.0071
71105811|NCT00402987|141718328|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.37||||0.001||95.0|1.6|7.1||Analysis for 6 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||7.1|1.6|0.001
71018885|NCT03985293|141545163|SUPERIORITY||Difference in LS Mean|-0.9|||<|0.0001|TWO_SIDED|90.0|-1.18|-0.62|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.62|-1.18|<.0001
71018886|NCT03985293|141545163|SUPERIORITY||Difference in LS Mean|-1.01|||<|0.0001|TWO_SIDED|90.0|-1.3|-0.73|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.73|-1.30|<.0001
71018887|NCT03985293|141545163|SUPERIORITY||Difference in LS Mean|-0.94|||<|0.0001|TWO_SIDED|90.0|-1.24|-0.65|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.65|-1.24|<.0001
71018888|NCT03985293|141545163|SUPERIORITY||Difference in LS Mean|-1.16|||<|0.0001|TWO_SIDED|90.0|-1.47|-0.86|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.86|-1.47|<.0001
71018889|NCT03985293|141545164|SUPERIORITY||Odds Ratio (OR)|5.11|||||TWO_SIDED|90.0|1.84|14.18|||Regression, Logistic||The Odds ratio model included multiple imputation. PF-06882961 = Test Placebo = Reference|||14.18|1.84|
71018890|NCT03985293|141545164|SUPERIORITY||Odds Ratio (OR)|16.85|||||TWO_SIDED|90.0|6.18|45.93|||Regression, Logistic||The Odds ratio model included multiple imputation. PF-06882961 = Test Placebo = Reference|||45.93|6.18|
71105812|NCT00402987|141718328|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.05||||0.004||95.0|1.4|6.5||Analysis for 6 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||6.5|1.4|0.004
71105813|NCT00402987|141718328|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.9||||0.752||95.0|0.5|1.7||Analysis for 6 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||1.7|0.5|0.752
71105814|NCT00402987|141718328|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.57|||<|0.001||95.0|1.9|10.7||Analysis for 2 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||10.7|1.9|<0.001
71105815|NCT00402987|141718328|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.68||||0.003||95.0|1.6|8.7||Analysis for 2 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||8.7|1.6|0.003
71105816|NCT00402987|141718328|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.81||||0.511||95.0|0.4|1.5||Analysis for 2 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||1.5|0.4|0.511
71018891|NCT03985293|141545164|SUPERIORITY||Odds Ratio (OR)|18.79|||||TWO_SIDED|90.0|7.03|50.21|||Regression, Logistic||The Odds ratio model included multiple imputation. PF-06882961 = Test Placebo = Reference|||50.21|7.03|
71052269|NCT03118570|141609382|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.19||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.190
71052270|NCT03118570|141609382|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.704||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.704
71105817|NCT00402987|141718328|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.05||||0.009||95.0|1.3|7.0||Analysis for 6 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||7.0|1.3|0.009
71105818|NCT00402987|141718328|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.88||||0.014||95.0|1.2|6.7||Analysis for 6 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||6.7|1.2|0.014
71018892|NCT03985293|141545164|SUPERIORITY||Odds Ratio (OR)|23.97|||||TWO_SIDED|90.0|8.66|66.39|||Regression, Logistic||The Odds ratio model included multiple imputation. PF-06882961 = Test Placebo = Reference|||66.39|8.66|
71018893|NCT03985293|141545164|SUPERIORITY||Odds Ratio (OR)|24.46|||||TWO_SIDED|90.0|8.72|68.57|||Regression, Logistic||The Odds ratio model included multiple imputation. PF-06882961 = Test Placebo = Reference|||68.57|8.72|
71018894|NCT03985293|141545165|SUPERIORITY||Difference in LS Mean|-0.09||||0.1578|TWO_SIDED|90.0|-0.19|0.01|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.01|-0.19|0.1578
71018895|NCT03985293|141545165|SUPERIORITY||Difference in LS Mean|-0.22||||0.0003|TWO_SIDED|90.0|-0.32|-0.12|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.12|-0.32|0.0003
71105819|NCT00402987|141718328|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.94||||0.863||95.0|0.5|1.9||Analysis for 6 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||1.9|0.5|0.863
71052271|NCT03118570|141609382|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.002||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.002
71052272|NCT03118570|141609382|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.021||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.021
71052273|NCT03118570|141609382|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.504||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.504
71052274|NCT03118570|141609382|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.462||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.462
71052275|NCT03118570|141609382|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.134||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.134
71052276|NCT03118570|141609382|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.086||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.086
71052277|NCT03118570|141609382|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.199||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.199
71052278|NCT03118570|141609382|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.219||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 8||||0.219
71052279|NCT03118570|141609382|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.112||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.112
71052280|NCT03118570|141609382|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.086||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.086
71052281|NCT03118570|141609382|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.245||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.245
71052282|NCT03118570|141609382|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.232||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.232
71105820|NCT00402987|141718329|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.92||||0.004||95.0|1.4|6.1||12 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||6.1|1.4|0.004
71105821|NCT00402987|141718329|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.37||||0.052||95.0|1.0|5.7||12 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||5.7|1.0|0.052
71052283|NCT03118570|141609382|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.237||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.237
71052284|NCT03118570|141609382|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.088||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.088
71052285|NCT03118570|141609382|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.302||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.302
71052286|NCT03118570|141609382|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.626||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.626
71105822|NCT00402987|141718329|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.13||||0.095||95.0|0.9|5.1||12 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||5.1|0.9|0.095
71105823|NCT00402987|141718329|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.38||||0.431||95.0|0.6|3.0||12 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||3.0|0.6|0.431
71105824|NCT00402987|141718329|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.23||||0.602||95.0|0.6|2.7||12 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||2.7|0.6|0.602
71105825|NCT00402987|141718329|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.814||95.0|0.4|2.8||12 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||2.8|0.4|0.814
71105826|NCT00402987|141718329|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.88||||0.014||95.0|1.2|6.7||12 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||6.7|1.2|0.014
71105827|NCT00402987|141718329|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.23||||0.016||95.0|1.2|8.4||12 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||8.4|1.2|0.016
70932062|NCT02307682|141364347|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-5.3|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||4.4|-5.3|
70932063|NCT02307682|141364347|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-5.7|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.4|-5.7|
70932064|NCT02307682|141364347|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-3.4|7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||7.3|-3.4|
70932065|NCT02307682|141364348|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-2.4|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||5.5|-2.4|
70932066|NCT02307682|141364348|OTHER||Difference in proportions|2.4|||||TWO_SIDED|95.0|-1.8|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||6.8|-1.8|
71052287|NCT03118570|141609382|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.517||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 8||||0.517
70932067|NCT02307682|141364348|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-4.1|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||3.8|-4.1|
70932068|NCT02307682|141364348|OTHER||Difference in proportions|2.7|||||TWO_SIDED|95.0|-1.7|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||6.8|-1.7|
70932069|NCT02307682|141364348|OTHER||Difference in proportions|1.8|||||TWO_SIDED|95.0|-2.3|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||6.5|-2.3|
71105828|NCT00402987|141718329|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.54||||0.063||95.0|0.9|6.8||12 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||6.8|0.9|0.063
71105829|NCT00402987|141718329|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.13||||0.775||95.0|0.5|2.7||12 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||2.7|0.5|0.775
71105830|NCT00402987|141718329|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.89||||0.779||95.0|0.4|2.0||12 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||2.0|0.4|0.779
70932070|NCT02307682|141364348|OTHER||Difference in proportions|3.4|||||TWO_SIDED|95.0|-0.9|7.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||7.9|-0.9|
70932071|NCT02307682|141364348|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-5.4|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||4.0|-5.4|
70932072|NCT02307682|141364348|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-6.2|3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||3.2|-6.2|
70932073|NCT02307682|141364348|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-5.4|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||3.3|-5.4|
70932074|NCT02307682|141364348|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-2.9|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||6.4|-2.9|
71052288|NCT03118570|141609382|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.262||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.262
71052289|NCT03118570|141609383|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||< 0.001
71052290|NCT03118570|141609383|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.004||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.004
70932075|NCT02307682|141364348|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-5.2|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||3.9|-5.2|
71105831|NCT00402987|141718329|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.624||95.0|0.5|3.3||12 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||3.3|0.5|0.624
71105832|NCT00402987|141718330|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Analysis for meaningful Relief at 2 hours|Regression, Logistic|Treatment as a factor||||||0.001
71105833|NCT00402987|141718330|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0||||Analysis for meaningful Relief at 2 hours|Regression, Logistic|Treatment as a factor||||||0.012
71105834|NCT00402987|141718330|SUPERIORITY_OR_OTHER_LEGACY|||||||0.453||95.0||||Analysis for meaningful Relief at 2 hours|Regression, Logistic|Treatment as a factor||||||0.453
71105835|NCT00402987|141718330|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Analysis for meaningful Relief at 6 hours|Regression, Logistic|Treatment as a factor||||||<0.001
71105836|NCT00402987|141718330|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Analysis for meaningful Relief at 6 hours|Regression, Logistic|Treatment as a factor||||||0.001
71105837|NCT00402987|141718330|SUPERIORITY_OR_OTHER_LEGACY|||||||0.814||95.0||||Analysis for meaningful Relief at 6 hours|Regression, Logistic|Treatment as a factor||||||0.814
71105838|NCT00402987|141718330|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024||95.0||||Analysis for Much Improvement at 2 hours|Regression, Logistic|Treatment as a factor||||||0.024
71105839|NCT00402987|141718330|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0||||Analysis for Much Improvement at 2 hours|Regression, Logistic|Treatment as a factor||||||0.022
71105840|NCT00402987|141718330|SUPERIORITY_OR_OTHER_LEGACY|||||||0.966||95.0||||Analysis for Much Improvement at 2 hours|Regression, Logistic|Treatment as a factor||||||0.966
71105841|NCT00402987|141718330|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Analysis for Much Improvement at 6 hours|Regression, Logistic|Treatment as a factor||||||0.001
70932076|NCT02307682|141364348|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-1.4|8.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||8.8|-1.4|
71018896|NCT03985293|141545165|SUPERIORITY||Difference in LS Mean|-0.2||||0.0013|TWO_SIDED|90.0|-0.3|-0.1|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.10|-0.30|0.0013
71018897|NCT03985293|141545165|SUPERIORITY||Difference in LS Mean|-0.24||||0.0001|TWO_SIDED|90.0|-0.34|-0.14|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.14|-0.34|0.0001
71018898|NCT03985293|141545165|SUPERIORITY||Difference in LS Mean|-0.26|||<|0.0001|TWO_SIDED|90.0|-0.36|-0.16|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.16|-0.36|<.0001
71018899|NCT03985293|141545166|SUPERIORITY||Difference in LS Mean|-0.3||||0.0013|TWO_SIDED|90.0|-0.46|-0.15|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.15|-0.46|0.0013
71105842|NCT00402987|141718330|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Analysis for Much Improvement at 6 hours|Regression, Logistic|Treatment as a factor||||||0.001
71105843|NCT00402987|141718330|SUPERIORITY_OR_OTHER_LEGACY|||||||0.798||95.0||||Analysis for Much Improvement at 6 hours|Regression, Logistic|Treatment as a factor||||||0.798
71105844|NCT00402987|141718331|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor||||||<0.001
71105845|NCT00402987|141718331|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor||||||<0.001
71105846|NCT00402987|141718331|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor||||||0.008
71105847|NCT00402987|141718331|SUPERIORITY_OR_OTHER_LEGACY|||||||0.709||95.0||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor||||||0.709
71105848|NCT00402987|141718331|SUPERIORITY_OR_OTHER_LEGACY|||||||0.331||95.0||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor||||||0.331
71105849|NCT00402987|141718331|SUPERIORITY_OR_OTHER_LEGACY|||||||0.246||95.0||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor||||||0.246
71105850|NCT00402987|141718331|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor||||||0.001
71105851|NCT00402987|141718331|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor||||||<0.001
71105852|NCT00402987|141718331|SUPERIORITY_OR_OTHER_LEGACY|||||||0.219||95.0||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor||||||0.219
71105853|NCT00402987|141718331|SUPERIORITY_OR_OTHER_LEGACY|||||||0.095||95.0||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor||||||0.095
71105854|NCT00402987|141718331|SUPERIORITY_OR_OTHER_LEGACY|||||||0.463||95.0||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor||||||0.463
71105855|NCT00402987|141718331|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038||95.0||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor||||||0.038
71105856|NCT00402987|141718332|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||Regression, Logistic|Treatment as a factor||||||0.001
71105857|NCT00402987|141718332|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0|||||Regression, Logistic|Treatment as a factor||||||0.008
71105858|NCT00402987|141718332|SUPERIORITY_OR_OTHER_LEGACY|||||||0.557||95.0|||||Regression, Logistic|Treatment as a factor||||||0.557
71105859|NCT00402987|141718333|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor||||||<0.001
71105860|NCT00402987|141718333|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor||||||0.002
71105861|NCT00402987|141718333|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036||95.0||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor||||||0.036
71105862|NCT00402987|141718333|SUPERIORITY_OR_OTHER_LEGACY|||||||0.339||95.0||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor||||||0.339
71105863|NCT00402987|141718333|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor||||||1.000
70932077|NCT02307682|141364348|OTHER||Difference in proportions|-2.3|||||TWO_SIDED|95.0|-6.8|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.3|-6.8|
70932078|NCT02307682|141364348|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-4.7|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||5.8|-4.7|
70932079|NCT02307682|141364348|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-5.0|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.4|-5.0|
70932080|NCT02307682|141364348|OTHER||Difference in proportions|-1.1|||||TWO_SIDED|95.0|-6.1|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.0|-6.1|
70932081|NCT02307682|141364348|OTHER||Difference in proportions|2.8|||||TWO_SIDED|95.0|-1.8|7.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||7.7|-1.8|
71018900|NCT03985293|141545166|SUPERIORITY||Difference in LS Mean|-0.43|||<|0.0001|TWO_SIDED|90.0|-0.58|-0.28|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.28|-0.58|<.0001
71018901|NCT03985293|141545166|SUPERIORITY||Difference in LS Mean|-0.55|||<|0.0001|TWO_SIDED|90.0|-0.7|-0.4|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.40|-0.70|<.0001
71018902|NCT03985293|141545166|SUPERIORITY||Difference in LS Mean|-0.5|||<|0.0001|TWO_SIDED|90.0|-0.66|-0.35|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.35|-0.66|<.0001
71018903|NCT03985293|141545166|SUPERIORITY||Difference in LS Mean|-0.56|||<|0.0001|TWO_SIDED|90.0|-0.71|-0.41|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.41|-0.71|<.0001
71018904|NCT03985293|141545167|SUPERIORITY||Difference in LS Mean|-0.4||||0.0004|TWO_SIDED|90.0|-0.59|-0.22|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.22|-0.59|0.0004
71105864|NCT00402987|141718333|SUPERIORITY_OR_OTHER_LEGACY|||||||0.401||95.0||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor||||||0.401
71018905|NCT03985293|141545167|SUPERIORITY||Difference in LS Mean|-0.64|||<|0.0001|TWO_SIDED|90.0|-0.81|-0.46|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.46|-0.81|<.0001
71018906|NCT03985293|141545167|SUPERIORITY||Difference in LS Mean|-0.77|||<|0.0001|TWO_SIDED|90.0|-0.95|-0.59|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.59|-0.95|<.0001
71018907|NCT03985293|141545167|SUPERIORITY||Difference in LS Mean|-0.72|||<|0.0001|TWO_SIDED|90.0|-0.91|-0.53|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.53|-0.91|<.0001
71018908|NCT03985293|141545167|SUPERIORITY||Difference in LS Mean|-0.77|||<|0.0001|TWO_SIDED|90.0|-0.95|-0.59|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.59|-0.95|<.0001
71018909|NCT03985293|141545168|SUPERIORITY||Difference in LS Mean|-0.37||||0.0054|TWO_SIDED|90.0|-0.59|-0.15|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.15|-0.59|0.0054
71018910|NCT03985293|141545168|SUPERIORITY||Difference in LS Mean|-0.65|||<|0.0001|TWO_SIDED|90.0|-0.86|-0.44|||Mixed Models Analysis||PF-06882961 = Test Placebo = Reference|||-0.44|-0.86|<.0001
71018911|NCT03985293|141545168|SUPERIORITY||Difference in LS Mean|-0.84|||<|0.0001|TWO_SIDED|90.0|-1.06|-0.63|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.63|-1.06|<.0001
71018912|NCT03985293|141545168|SUPERIORITY||Difference in LS Mean|-0.8|||<|0.0001|TWO_SIDED|90.0|-1.02|-0.57|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.57|-1.02|<.0001
71018913|NCT03985293|141545168|SUPERIORITY||Difference in LS Mean|-0.89|||<|0.0001|TWO_SIDED|90.0|-1.11|-0.67|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.67|-1.11|<.0001
71105865|NCT00402987|141718333|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor||||||0.003
71105866|NCT00402987|141718333|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor||||||0.002
70932082|NCT02307682|141364348|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-2.7|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||6.8|-2.7|
70932083|NCT02307682|141364348|OTHER||Difference in proportions|-1.1|||||TWO_SIDED|95.0|-5.9|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||4.0|-5.9|
71018914|NCT03985293|141545169|SUPERIORITY||Difference in LS Mean|-0.44||||0.0061|TWO_SIDED|90.0|-0.71|-0.18|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.18|-0.71|0.0061
71105867|NCT00402987|141718333|SUPERIORITY_OR_OTHER_LEGACY|||||||0.223||95.0||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor||||||0.223
71105868|NCT00402987|141718333|SUPERIORITY_OR_OTHER_LEGACY|||||||0.198||95.0||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor||||||0.198
71105869|NCT00402987|141718333|SUPERIORITY_OR_OTHER_LEGACY|||||||0.604||95.0||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor||||||0.604
71105870|NCT00402987|141718333|SUPERIORITY_OR_OTHER_LEGACY|||||||0.117||95.0||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor||||||0.117
71105871|NCT00402987|141718336|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||Regression, Logistic|Treatment as a factor||||||0.001
71105872|NCT00402987|141718336|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Regression, Logistic|Treatment as a factor||||||<0.001
71105873|NCT00402987|141718336|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025||95.0|||||Regression, Logistic|Treatment as a factor||||||0.025
71105874|NCT00402987|141718336|SUPERIORITY_OR_OTHER_LEGACY|||||||0.539||95.0|||||Regression, Logistic|Treatment as a factor||||||0.539
71105875|NCT00402987|141718336|SUPERIORITY_OR_OTHER_LEGACY|||||||0.329||95.0|||||Regression, Logistic|Treatment as a factor||||||0.329
71105876|NCT00402987|141718336|SUPERIORITY_OR_OTHER_LEGACY|||||||0.171||95.0|||||Regression, Logistic|Treatment as a factor||||||0.171
71105877|NCT00402987|141718337|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0|||||Regression, Logistic|Treatment as a factor||||||0.007
71105878|NCT00402987|141718337|SUPERIORITY_OR_OTHER_LEGACY|||||||0.244||95.0|||||Regression, Logistic|Treatment as a factor||||||0.244
71105879|NCT00402987|141718337|SUPERIORITY_OR_OTHER_LEGACY|||||||0.096||95.0|||||Regression, Logistic|Treatment as a factor||||||0.096
71105880|NCT00402987|141718337|SUPERIORITY_OR_OTHER_LEGACY|||||||0.579||95.0|||||Regression, Logistic|Treatment as a factor||||||0.579
71105881|NCT00402987|141718337|SUPERIORITY_OR_OTHER_LEGACY|||||||0.277||95.0|||||Regression, Logistic|Treatment as a factor||||||0.277
71105882|NCT00402987|141718337|SUPERIORITY_OR_OTHER_LEGACY|||||||0.649||95.0|||||Regression, Logistic|Treatment as a factor||||||0.649
71105883|NCT00402987|141718338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.4|||<|0.001||95.0|7.5|23.2||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect||||23.2|7.5|<0.001
71105884|NCT00402987|141718338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.4||||0.003||95.0|4.9|24.0||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect||||24.0|4.9|0.003
71018915|NCT03985293|141545169|SUPERIORITY||Difference in LS Mean|-0.79|||<|0.0001|TWO_SIDED|90.0|-1.05|-0.54|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.54|-1.05|<.0001
71105885|NCT00402987|141718338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.2||||0.096||95.0|-1.5|17.8||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect||||17.8|-1.5|0.096
71105886|NCT00402987|141718338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.2||||0.141||95.0|-2.4|16.8||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect||||16.8|-2.4|0.141
71105887|NCT00402987|141718338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.849||95.0|-8.6|10.5||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect||||10.5|-8.6|0.849
71105888|NCT00402987|141718338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.3||||0.266||95.0|-4.8|17.4||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect||||17.4|-4.8|0.266
71105889|NCT00402987|141718338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.3||||0.141||95.0|-5.4|0.8||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect||||0.8|-5.4|0.141
71105890|NCT00402987|141718338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9||||0.312||95.0|-5.7|1.8||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect||||1.8|-5.7|0.312
71105891|NCT00402987|141718338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.724||95.0|-4.5|3.1||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect||||3.1|-4.5|0.724
71105892|NCT00402987|141718338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.398||95.0|-5.4|2.1||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect||||2.1|-5.4|0.398
71105893|NCT00402987|141718338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.846||95.0|-4.1|3.4||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect||||3.4|-4.1|0.846
71105894|NCT00402987|141718338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3||||0.572||95.0|-5.6|3.1||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect||||3.1|-5.6|0.572
71105895|NCT00402987|141718338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.8||||0.014||95.0|1.2|10.4||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect||||10.4|1.2|0.014
71105896|NCT00402987|141718338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6||||0.573||95.0|-4.0|7.2||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect||||7.2|-4.0|0.573
71105897|NCT00402987|141718338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.482||95.0|-7.7|3.6||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect||||3.6|-7.7|0.482
71105898|NCT00402987|141718338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.8||||0.007||95.0|2.2|13.5||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect||||13.5|2.2|0.007
71105899|NCT00402987|141718338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.2||||0.143||95.0|-1.4|9.8||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect||||9.8|-1.4|0.143
71105900|NCT00402987|141718338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.6||||0.273||95.0|-2.9|10.2||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect||||10.2|-2.9|0.273
71105901|NCT00402987|141718338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.0||||0.003||95.0|4.4|21.6||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect||||21.6|4.4|0.003
71105902|NCT00402987|141718338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.7||||0.029||95.0|1.2|22.2||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect||||22.2|1.2|0.029
71105903|NCT00402987|141718338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.2||||0.251||95.0|-4.4|16.8||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect||||16.8|-4.4|0.251
71105904|NCT00402987|141718338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.8||||0.204||95.0|-3.7|17.4||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect||||17.4|-3.7|0.204
71105905|NCT00402987|141718338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3||||0.808||95.0|-9.2|11.8||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect||||11.8|-9.2|0.808
71105906|NCT00402987|141718338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.5||||0.371||95.0|-6.6|17.7||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect||||17.7|-6.6|0.371
71018916|NCT03985293|141545169|SUPERIORITY||Difference in LS Mean|-0.98|||<|0.0001|TWO_SIDED|90.0|-1.24|-0.72|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.72|-1.24|<.0001
71018917|NCT03985293|141545169|SUPERIORITY||Difference in LS Mean|-0.83|||<|0.0001|TWO_SIDED|90.0|-1.1|-0.56|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.56|-1.10|<.0001
71018918|NCT03985293|141545169|SUPERIORITY||Difference in LS Mean|-1.03|||<|0.0001|TWO_SIDED|90.0|-1.3|-0.75|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.75|-1.30|<.0001
71018919|NCT03985293|141545170|SUPERIORITY||Difference in LS Mean|-17.13||||0.0014|TWO_SIDED|90.0|-25.94|-8.33|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-8.33|-25.94|0.0014
71018920|NCT03985293|141545170|SUPERIORITY||Difference in LS Mean|-16.38||||0.0021|TWO_SIDED|90.0|-25.08|-7.67|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|Difference in LS Mean|||-7.67|-25.08|0.0021
71018921|NCT03985293|141545170|SUPERIORITY||Difference in LS Mean|-22.2|||<|0.0001|TWO_SIDED|90.0|-30.88|-13.53|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-13.53|-30.88|<.0001
71018922|NCT03985293|141545170|SUPERIORITY||Difference in LS Mean|-18.59||||0.0006|TWO_SIDED|90.0|-27.43|-9.76|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-9.76|-27.43|0.0006
71018923|NCT03985293|141545170|SUPERIORITY||Difference in LS Mean|-25.33|||<|0.0001|TWO_SIDED|90.0|-34.0|-16.67|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-16.67|-34.00|<.0001
71052291|NCT03118570|141609383|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.08||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.080
71018924|NCT03985293|141545171|SUPERIORITY||Difference in LS Mean|-11.79||||0.0468|TWO_SIDED|90.0|-21.55|-2.04|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-2.04|-21.55|0.0468
71018925|NCT03985293|141545171|SUPERIORITY||Difference in LS Mean|-18.68||||0.0012|TWO_SIDED|90.0|-28.12|-9.25|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-9.25|-28.12|0.0012
71018926|NCT03985293|141545171|SUPERIORITY||Difference in LS Mean|-27.44|||<|0.0001|TWO_SIDED|90.0|-37.03|-17.85|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-17.85|-37.03|<.0001
71018927|NCT03985293|141545171|SUPERIORITY||Difference in LS Mean|-27.36|||<|0.0001|TWO_SIDED|90.0|-37.22|-17.51|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-17.51|-37.22|<.0001
71018928|NCT03985293|141545171|SUPERIORITY||Difference in LS Mean|-28.09|||<|0.0001|TWO_SIDED|90.0|-37.72|-18.45|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-18.45|-37.72|<.0001
71018929|NCT03985293|141545172|SUPERIORITY||Difference in LS Mean|-15.9||||0.0091|TWO_SIDED|90.0|-25.9|-5.9|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-5.90|-25.90|0.0091
71018930|NCT03985293|141545172|SUPERIORITY||Difference in LS Mean|-25.53|||<|0.0001|TWO_SIDED|90.0|-35.18|-15.89|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-15.89|-35.18|<.0001
71105907|NCT00402987|141718339|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||<0.001
71105908|NCT00402987|141718339|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.002
71105909|NCT00402987|141718339|SUPERIORITY_OR_OTHER_LEGACY|||||||0.235||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.235
71018931|NCT03985293|141545172|SUPERIORITY||Difference in LS Mean|-30.01|||<|0.0001|TWO_SIDED|90.0|-39.8|-20.21|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-20.21|-39.80|<.0001
71018932|NCT03985293|141545172|SUPERIORITY||Difference in LS Mean|-27.48|||<|0.0001|TWO_SIDED|90.0|-37.63|-17.33|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-17.33|-37.63|<.0001
71018933|NCT03985293|141545172|SUPERIORITY||Difference in LS Mean|-31.77|||<|0.0001|TWO_SIDED|90.0|-41.77|-21.78|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-21.78|-41.77|<.0001
71018934|NCT03985293|141545173|SUPERIORITY||Difference in LS Mean|-3.63||||0.5449|TWO_SIDED|90.0|-13.51|6.25|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||6.25|-13.51|0.5449
71018935|NCT03985293|141545173|SUPERIORITY||Difference in LS Mean|-17.12||||0.0031|TWO_SIDED|90.0|-26.62|-7.63|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-7.63|-26.62|0.0031
71052292|NCT03118570|141609383|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.031||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.031
71105910|NCT00402987|141718339|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.012
71105911|NCT00402987|141718339|SUPERIORITY_OR_OTHER_LEGACY|||||||0.438||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.438
71105912|NCT00402987|141718339|SUPERIORITY_OR_OTHER_LEGACY|||||||0.067||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.067
71018936|NCT03985293|141545173|SUPERIORITY||Difference in LS Mean|-20.64||||0.0005|TWO_SIDED|90.0|-30.31|-10.96|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-10.96|-30.31|0.0005
71018937|NCT03985293|141545173|SUPERIORITY||Difference in LS Mean|-24.12|||<|0.0001|TWO_SIDED|90.0|-34.2|-14.04|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-14.04|-34.20|<.0001
71052293|NCT03118570|141609384|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.06||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.060
71018938|NCT03985293|141545173|SUPERIORITY||Difference in LS Mean|-25.21|||<|0.0001|TWO_SIDED|90.0|-35.44|-14.97|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-14.97|-35.44|<.0001
71018939|NCT03985293|141545174|SUPERIORITY||Difference in LS Mean|-7.7||||0.294|TWO_SIDED|90.0|-19.78|4.38|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||4.38|-19.78|0.2940
71018940|NCT03985293|141545174|SUPERIORITY||Difference in LS Mean|-23.77||||0.0008|TWO_SIDED|90.0|-35.37|-12.17|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-12.17|-35.37|0.0008
71018941|NCT03985293|141545174|SUPERIORITY||Difference in LS Mean|-33.23|||<|0.0001|TWO_SIDED|90.0|-45.05|-21.4|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-21.40|-45.05|<.0001
71018942|NCT03985293|141545174|SUPERIORITY||Difference in LS Mean|-31.66|||<|0.0001|TWO_SIDED|90.0|-44.14|-19.19|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-19.19|-44.14|<.0001
71018943|NCT03985293|141545174|SUPERIORITY||Difference in LS Mean|-33.59|||<|0.0001|TWO_SIDED|90.0|-46.67|-20.51|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-20.51|-46.67|<.0001
71018944|NCT03985293|141545175|SUPERIORITY||Difference in LS Mean|-14.12||||0.0464|TWO_SIDED|90.0|-25.77|-2.47|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-2.47|-25.77|0.0464
71018945|NCT03985293|141545175|SUPERIORITY||Difference in LS Mean|-25.84||||0.0002|TWO_SIDED|90.0|-37.05|-14.62|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-14.62|-37.05|0.0002
71018946|NCT03985293|141545175|SUPERIORITY||Difference in LS Mean|-31.78|||<|0.0001|TWO_SIDED|90.0|-43.2|-20.35|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-20.35|-43.20|<.0001
71018947|NCT03985293|141545175|SUPERIORITY||Difference in LS Mean|-27.02||||0.0002|TWO_SIDED|90.0|-39.03|-15.01|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-15.01|-39.03|0.0002
71018948|NCT03985293|141545175|SUPERIORITY||Difference in LS Mean|-33.24|||<|0.0001|TWO_SIDED|90.0|-45.63|-20.84|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-20.84|-45.63|<.0001
71018949|NCT03985293|141545176|SUPERIORITY||Difference in LS Mean|0.06||||0.8011|TWO_SIDED|90.0|-0.33|0.44|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.44|-0.33|0.8011
71018950|NCT03985293|141545176|SUPERIORITY||Difference in LS Mean|0.02||||0.9149|TWO_SIDED|90.0|-0.35|0.4|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.40|-0.35|0.9149
71018951|NCT03985293|141545176|SUPERIORITY||Difference in LS Mean|-0.08||||0.7216|TWO_SIDED|90.0|-0.46|0.3|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.30|-0.46|0.7216
71018952|NCT03985293|141545176|SUPERIORITY||Difference in LS Mean|-0.42||||0.0758|TWO_SIDED|90.0|-0.8|-0.03|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.03|-0.80|0.0758
71018953|NCT03985293|141545176|SUPERIORITY||Difference in LS Mean|-0.4||||0.086|TWO_SIDED|90.0|-0.77|-0.02|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.02|-0.77|0.0860
71018954|NCT03985293|141545177|SUPERIORITY||Difference in LS Mean|-0.08||||0.7898|TWO_SIDED|90.0|-0.59|0.42|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.42|-0.59|0.7898
71018955|NCT03985293|141545177|SUPERIORITY||Difference in LS Mean|0.16||||0.5829|TWO_SIDED|90.0|-0.33|0.66|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.66|-0.33|0.5829
71018956|NCT03985293|141545177|SUPERIORITY||Difference in LS Mean|-0.52||||0.0827|TWO_SIDED|90.0|-1.02|-0.03|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.03|-1.02|0.0827
71018957|NCT03985293|141545177|SUPERIORITY||Difference in LS Mean|-0.8||||0.0101|TWO_SIDED|90.0|-1.31|-0.29|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.29|-1.31|0.0101
71018958|NCT03985293|141545177|SUPERIORITY||Difference in LS Mean|-1.09||||0.0004|TWO_SIDED|90.0|-1.59|-0.59|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.59|-1.59|0.0004
71018959|NCT03985293|141545178|SUPERIORITY||Difference in LS Mean|-0.1||||0.7985|TWO_SIDED|90.0|-0.75|0.55|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.55|-0.75|0.7985
71018960|NCT03985293|141545178|SUPERIORITY||Difference in LS Mean|-0.23||||0.5484|TWO_SIDED|90.0|-0.86|0.4|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.40|-0.86|0.5484
71018961|NCT03985293|141545178|SUPERIORITY||Difference in LS Mean|-0.75||||0.0541|TWO_SIDED|90.0|-1.38|-0.11|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.11|-1.38|0.0541
71018962|NCT03985293|141545178|SUPERIORITY||Difference in LS Mean|-1.6|||<|0.0001|TWO_SIDED|90.0|-2.26|-0.95|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.95|-2.26|<.0001
71018963|NCT03985293|141545178|SUPERIORITY||Difference in LS Mean|-2.25|||<|0.0001|TWO_SIDED|90.0|-2.9|-1.6|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-1.60|-2.90|<.0001
71018964|NCT03985293|141545179|SUPERIORITY||Difference in LS Mean|0.31||||0.4692|TWO_SIDED|90.0|-0.4|1.03|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||1.03|-0.40|0.4692
71018965|NCT03985293|141545179|SUPERIORITY||Difference in LS Mean|0.09||||0.8274|TWO_SIDED|90.0|-0.6|0.78|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.78|-0.60|0.8274
71018966|NCT03985293|141545179|SUPERIORITY||Difference in LS Mean|-0.72||||0.0887|TWO_SIDED|90.0|-1.42|-0.02|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.02|-1.42|0.0887
71105913|NCT00402987|141718340|SUPERIORITY_OR_OTHER_LEGACY|||||||0.128||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.128
71105914|NCT00402987|141718340|SUPERIORITY_OR_OTHER_LEGACY|||||||0.123||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.123
71105915|NCT00402987|141718340|SUPERIORITY_OR_OTHER_LEGACY|||||||0.266||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.266
71018967|NCT03985293|141545179|SUPERIORITY||Difference in LS Mean|-1.61||||0.0003|TWO_SIDED|90.0|-2.33|-0.88|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.88|-2.33|0.0003
71018968|NCT03985293|141545179|SUPERIORITY||Difference in LS Mean|-2.95|||<|0.0001|TWO_SIDED|90.0|-3.67|-2.22|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-2.22|-3.67|<.0001
71018969|NCT03985293|141545180|SUPERIORITY||Difference in LS Mean|0.15||||0.7758|TWO_SIDED|90.0|-0.7|0.99|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.99|-0.70|0.7758
71018970|NCT03985293|141545180|SUPERIORITY||Difference in LS Mean|0.23||||0.6367|TWO_SIDED|90.0|-0.58|1.05|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||1.05|-0.58|0.6367
71018971|NCT03985293|141545180|SUPERIORITY||Difference in LS Mean|-0.81||||0.1082|TWO_SIDED|90.0|-1.63|0.02|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.02|-1.63|0.1082
71052294|NCT03118570|141609384|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.015||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.015
71052295|NCT03118570|141609384|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.795||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.795
71052296|NCT03118570|141609384|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.011||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.011
71052297|NCT03118570|141609384|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.047||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.047
71052298|NCT03118570|141609384|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.756||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.756
71105916|NCT00402987|141718340|SUPERIORITY_OR_OTHER_LEGACY|||||||0.849||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.849
71018972|NCT03985293|141545180|SUPERIORITY||Difference in LS Mean|-2.28|||<|0.0001|TWO_SIDED|90.0|-3.14|-1.42|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-1.42|-3.14|<.0001
71018973|NCT03985293|141545180|SUPERIORITY||Difference in LS Mean|-3.57|||<|0.0001|TWO_SIDED|90.0|-4.44|-2.7|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-2.70|-4.44|<.0001
71018974|NCT03985293|141545181|SUPERIORITY||Difference in LS Mean|0.45||||0.4325|TWO_SIDED|90.0|-0.5|1.41|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||1.41|-0.50|0.4325
71018975|NCT03985293|141545181|SUPERIORITY||Difference in LS Mean|0.38||||0.4978|TWO_SIDED|90.0|-0.54|1.3|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||1.30|-0.54|0.4978
71018976|NCT03985293|141545181|SUPERIORITY||Difference in LS Mean|-0.73||||0.197|TWO_SIDED|90.0|-1.66|0.2|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.20|-1.66|0.1970
71018977|NCT03985293|141545181|SUPERIORITY||Difference in LS Mean|-2.04||||0.0006|TWO_SIDED|90.0|-3.01|-1.07|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-1.07|-3.01|0.0006
71018978|NCT03985293|141545181|SUPERIORITY||Difference in LS Mean|-4.17|||<|0.0001|TWO_SIDED|90.0|-5.15|-3.18|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-3.18|-5.15|<.0001
71018979|NCT03302299|141545214|SUPERIORITY||Odds Ratio (OR)|1.59|||<|0.01|TWO_SIDED|95.0|0.94|2.71||global p-value for 3-category alcohol use variable in a multivariable generalized estimating equation logistic regression model of sub-optimal INH adherence.|Regression, Logistic||OR for participants with moderate alcohol use in the prior 3 months, compared to those with no alcohol use in the prior 3 months.|||2.71|0.94|<0.01
71018980|NCT03302299|141545214|SUPERIORITY||Odds Ratio (OR)|2.78|||<|0.01|TWO_SIDED|95.0|1.62|4.76||global p-value for 3-category alcohol use variable in a multivariable generalized estimating equation logistic regression model of sub-optimal INH adherence.|Regression, Logistic||OR is for participants with unhealthy alcohol use in the prior 3 months, compared to those with no alcohol use in the prior 3 months.|||4.76|1.62|<0.01
71018981|NCT00858234|141545222|OTHER|Accumulation Ratio (Day 11 AUC0-24hr/Day 1 AUC0-24hr)|Accumulation ratio|1.08|||||TWO_SIDED|90.0|0.8|1.45|||||Back-transformed least squares mean difference and 90% confidence interval from mixed effects model performed on natural log-transformed values.|||1.45|0.80|
71052299|NCT03118570|141609384|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.006||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.006
71052300|NCT03118570|141609384|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.137||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.137
71052301|NCT03118570|141609384|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.639||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.639
71105917|NCT00402987|141718340|SUPERIORITY_OR_OTHER_LEGACY|||||||0.828||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.828
71105918|NCT00402987|141718340|SUPERIORITY_OR_OTHER_LEGACY|||||||0.741||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.741
70932084|NCT02307682|141364348|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-4.7|4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||4.9|-4.7|
70932085|NCT02307682|141364348|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-5.7|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.5|-5.7|
70932086|NCT02307682|141364348|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-6.5|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||3.3|-6.5|
71018982|NCT04318535|141545223|EQUIVALENCE|Bioequivalence was to be determined if the 90% confidence interval of the geometric least square mean ratio of Cmax falls within the 0.80-1.25 range.|Ratio of geometric least square mean|1.157|||||TWO_SIDED|90.0|1.103|1.213|||||T1 versus R was the primary interest of comparison for this outcome measure.|||1.213|1.103|
71018983|NCT04318535|141545224|EQUIVALENCE|Bioequivalence was to be determined if the 90% confidence interval of the geometric least square mean ratio of AUC(0-t) falls within the 0.80-1.25 range.|Ratio of geometric least square mean|1.032|||||TWO_SIDED|90.0|0.974|1.094|||||T1 versus R was the primary interest of comparison for this outcome measure.|||1.094|0.974|
71018984|NCT04318535|141545225|EQUIVALENCE|Bioequivalence was to be determined if the 90% confidence interval of the geometric least square mean ratio of AUC(0-inf) falls within the 0.80-1.25 range.|Ratio of geometric least square mean|1.03|||||TWO_SIDED|90.0|0.971|1.093|||||T1 versus R was the primary interest of comparison for this outcome measure.|||1.093|0.971|
71018985|NCT00529802|141545317|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9||||0.69|TWO_SIDED|95.0|-9.3|13.23|||t-test, 2 sided|Relative changes in tumor size were log-transformed to satisfy the normality assumption for the t-test.|Mean difference is the difference between Low and High SUV uptake groups in tumor size percent (%) change from baseline, and is reported on the raw scale. Tumor size changes were log-transformed for the t-test.|Relative changes in tumor size were log-transformed to satisfy the normality assumption.||13.23|-9.3|0.69
71018986|NCT00529802|141545318|SUPERIORITY_OR_OTHER||Slope|0.0028|STANDARD_ERROR_OF_MEAN|0.00109||0.013|TWO_SIDED|95.0|0.00063|0.004997|||Regression, Linear|Tumor size change (outcome variable) was log-transformed to satisfy the normality assumption.|Outcome was log(tumor size at 8 weeks/tumor size at baseline), and the predictor was the early change in aveSUVmax \[(aveSUVmax at 2 weeks - aveSUVmax at baseline)/aveSUVmax at baseline\] x 100%.|The relationship between early changes in SUV uptake (from baseline to 2 weeks) and tumor size changes (from baseline to 8 weeks) were examined using linear regression models. Tumor size change was log-transformed to satisfy the normality assumption.||0.004997|0.00063|0.013
71018987|NCT02007369|141545319|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.21||||0.033|TWO_SIDED|95.0|0.05|0.89|||Regression, Logistic|||||0.89|0.05|0.033
71018988|NCT02007369|141545319|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.934|TWO_SIDED|95.0|0.36|3.01|||Regression, Logistic|||||3.01|0.36|0.934
71018989|NCT02007369|141545320|SUPERIORITY_OR_OTHER|||||||0.002|||||||Fisher Exact|||||||0.002
71018990|NCT02007369|141545320|SUPERIORITY_OR_OTHER|||||||0.199|||||||Fisher Exact|||||||0.199
71018991|NCT02007369|141545321|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61||||0.285|TWO_SIDED|95.0|0.25|1.5|||Regression, Logistic|||||1.50|0.25|0.285
71018992|NCT02007369|141545321|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.597|TWO_SIDED|95.0|0.31|1.97|||Regression, Logistic|||||1.97|0.31|0.597
71018993|NCT02007369|141545322|SUPERIORITY_OR_OTHER|||||||0.023|||||||Fisher Exact|||||||0.023
71052302|NCT03118570|141609384|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.325||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.325
71052303|NCT03118570|141609384|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.108||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.108
70932087|NCT02307682|141364348|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-2.7|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||6.9|-2.7|
71018994|NCT02007369|141545322|SUPERIORITY_OR_OTHER|||||||0.527|||||||Fisher Exact|||||||0.527
71018995|NCT02253654|141545383|SUPERIORITY_OR_OTHER||Treatment difference|0.39|STANDARD_ERROR_OF_MEAN|3.53||0.46|ONE_SIDED|97.5|-6.58||||t-test, 1 sided|||The difference between treatment groups for the percent of hemoglobin measurements within 10.0 to 11.0 g/dL during the evaluation period was tested using a 1-sided t-test with a significance level of 0.025.|||-6.58|0.46
71018996|NCT00069160|141545393|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||||||>.05
71018997|NCT02576054|141545417|NON_INFERIORITY|The statistical criterion for success requires that the lower bound of two-sided 95% confidence interval (CI) of GMT ratio between boys enrolled in V501-200 and men enrolled in the Phase III study V501-122 be greater than 0.5% for each HPV type|GMT Ratio|1.25|||<|0.001|TWO_SIDED|95.0|1.0|1.57|||ANOVA|Log-transformed data using an analysis of variance model with a term for age-group|GMT Ratio= GMT PN200 divided by GMT PN122|Anti-HPV 6||1.57|1.00|<0.001
71105919|NCT05528770|141718341|SUPERIORITY||Mean Difference (Final Values)|2.23|STANDARD_DEVIATION|8.98||0.4291|TWO_SIDED|95.0|-3.8|8.3|||t-test, 2 sided|||||8.3|-3.8|0.4291
71105920|NCT03229538|141718356|OTHER||Adjusted Odds Ratio|0.86||||0.14|TWO_SIDED|95.0|0.71|1.05|||Regression, Logistic|||||1.05|0.71|0.14
71105921|NCT03229538|141718356|OTHER||Percent Difference|-0.8|||||TWO_SIDED|95.0|-2.6|0.9|||||Difference = Methylprednisolone - Placebo|Rank = 97||0.9|-2.6|
71105922|NCT03229538|141718356|OTHER||Percent Difference|-1.5|||||TWO_SIDED|95.0|-3.5|0.5|||||Difference = Methylprednisolone - Placebo|Rank \> or = 96||0.5|-3.5|
70932088|NCT02307682|141364348|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-4.3|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||5.4|-4.3|
70932089|NCT02307682|141364348|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-4.6|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||5.3|-4.6|
70932090|NCT02307682|141364348|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-3.9|6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||6.6|-3.9|
70932091|NCT02307682|141364348|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-4.0|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.1|-4.0|
70932092|NCT02307682|141364348|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-3.8|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.2|-3.8|
70932093|NCT02307682|141364348|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-4.5|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||5.6|-4.5|
70932094|NCT02307682|141364348|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-3.8|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||6.8|-3.8|
70932095|NCT02307682|141364348|OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-2.9|7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||7.3|-2.9|
71052304|NCT03118570|141609384|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.078||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.078
71052305|NCT03118570|141609384|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.106||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.106
71052306|NCT03118570|141609384|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.236||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.236
71052307|NCT03118570|141609384|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.164||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.164
71052308|NCT03118570|141609384|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.031||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.031
71105923|NCT03229538|141718356|OTHER||Percent Difference|-2.2|||||TWO_SIDED|95.0|-4.4|0.1|||||Difference = Methylprednisolone - Placebo|Rank \> or = 95||0.1|-4.4|
71052309|NCT03118570|141609384|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.224||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.224
70932096|NCT02307682|141364348|OTHER||Difference in proportions|2.9|||||TWO_SIDED|95.0|-2.8|7.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||7.9|-2.8|
70932097|NCT02307682|141364348|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-5.5|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||4.5|-5.5|
71052310|NCT03118570|141609384|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.291||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.291
71052311|NCT03118570|141609384|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.324||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.324
71105924|NCT03229538|141718356|OTHER||Percent Difference|-0.8|||||TWO_SIDED|95.0|-4.3|2.7|||||Difference = Methylprednisolone - Placebo|Rank \> or = 94||2.7|-4.3|
71105925|NCT03229538|141718356|OTHER||Percent Difference|-3.8|||||TWO_SIDED|95.0|-7.8|0.2|||||Difference = Methylprednisolone - Placebo|Rank \> or = 93||0.2|-7.8|
70932098|NCT02307682|141364348|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-5.1|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||5.3|-5.1|
70932099|NCT02307682|141364348|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-4.3|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||6.7|-4.3|
70932100|NCT02307682|141364348|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-5.2|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||5.6|-5.2|
70932101|NCT02307682|141364348|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-4.6|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||6.4|-4.6|
70932102|NCT02307682|141364348|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-4.7|6.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||6.3|-4.7|
70932103|NCT02307682|141364348|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-4.8|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.2|-4.8|
70932104|NCT02307682|141364348|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-4.8|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.2|-4.8|
70932105|NCT02307682|141364348|OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-3.1|7.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||7.7|-3.1|
71018998|NCT02576054|141545417|NON_INFERIORITY|The statistical criterion for success requires that the lower bound of two-sided 95% confidence interval (CI) of GMT ratio between boys enrolled in V501-200 and men enrolled in the Phase III study V501-122 be greater than 0.5% for each HPV type|GMT Ratio|2.3|||<|0.001|TWO_SIDED|95.0|1.89|2.78|||ANOVA|Log-transformed data using an analysis of variance model with a term for age-group|GMT Ratio = GMT PN200 divided by GMT PN122|Anti-HPV 11||2.78|1.89|<0.001
71018999|NCT02576054|141545417|NON_INFERIORITY|The statistical criterion for success requires that the lower bound of two-sided 95% CI of GMT ratio between boys enrolled in V501-200 and men enrolled in the Phase III study V501-122 be greater than 0.5% for each HPV type|GMT Ratio|1.69|||<|0.001|TWO_SIDED|95.0|1.35|2.11|||ANOVA|Log-transformed data using an analysis of variance model with a term for age-group|GMT Ratio= GMT PN200 divided by GMT PN122|Anti-HPV 16||2.11|1.35|<0.001
70932106|NCT02307682|141364348|OTHER||Difference in proportions|3.3|||||TWO_SIDED|95.0|-2.9|8.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||8.7|-2.9|
71019000|NCT02576054|141545417|NON_INFERIORITY|The statistical criterion for success requires that the lower bound of two-sided 95% CI of GMT ratio between boys enrolled in V501-200 and men enrolled in the Phase III study V501-122 be greater than 0.5% for each HPV type|GMT Ratio|3.05|||<|0.001|TWO_SIDED|95.0|2.33|3.99|||ANOVA|Log-transformed data using an analysis of variance model with a term for age-group|GMT Ratio= GMT PN200 divided by GMT PN122|Anti-HPV 18||3.99|2.33|<0.001
71019001|NCT01190098|141545422|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: there is a non-inferiority region of 4 points.||||||0.027|||||||t-test, 1 sided|||||||0.027
71052312|NCT03118570|141609384|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.188||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.188
70932107|NCT02307682|141364348|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-4.5|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||6.4|-4.5|
71052313|NCT03118570|141609384|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.503||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.503
71019002|NCT01190098|141545423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.7||||0.23|TWO_SIDED||||||t-test, 2 sided|||||||0.23
71019003|NCT01190098|141545424|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.84|TWO_SIDED||||||t-test, 2 sided|||||||0.84
71019004|NCT01190098|141545425|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.37|TWO_SIDED||||||t-test, 2 sided|||||||0.37
71019005|NCT01190098|141545426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.8||||0.33|TWO_SIDED||||||t-test, 2 sided|||||||0.33
71105926|NCT03229538|141718356|OTHER||Percent Difference|-3.4|||||TWO_SIDED|95.0|-7.8|0.9|||||Difference = Methylprednisolone - Placebo|Rank \> or = 92||0.9|-7.8|
71105927|NCT03229538|141718356|OTHER||Percent Difference|-3.1|||||TWO_SIDED|95.0|-7.5|1.3|||||Difference = Methylprednisolone - Placebo|Rank \> or = 91||1.3|-7.5|
71019006|NCT01190098|141545427|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.92|TWO_SIDED||||||t-test, 2 sided|||||||0.92
71019007|NCT01190098|141545428|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.69|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.69
71019008|NCT01190098|141545429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.95|TWO_SIDED||||||t-test, 2 sided|||||||0.95
71019009|NCT02957682|141545430|NON_INFERIORITY|Upper confidence interval (CI) limit was compared to the noninferiority margin, which was 0.2%, and noninferiority was declared if the upper CI limit was below the noninferiority margin.|Least Square (LS) Mean Difference|-0.02||||0.6055|TWO_SIDED|95.0|-0.094|0.055||P-value was taken from mixed-effect model with repeated measures (MMRM) analysis.|Mixed-effect Model Repeated Measures||Model: fixed categorical effects of treatment group, randomization strata as per IVRS, time point, treatment-by-time point, strata-by-time point, continuous fixed covariates of baseline SWMS raw score value, baseline value by time-point interaction.|Change at Week 96||0.055|-0.094|0.6055
71019010|NCT00883740|141545520|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.15|||<|0.0001|TWO_SIDED|95.0|-26.69|-11.61||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||-11.61|-26.69|<0.0001
71019011|NCT00883740|141545521|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.54|||<|0.0001|TWO_SIDED|95.0|-23.29|-11.8||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||-11.80|-23.29|<0.0001
71052314|NCT03118570|141609384|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.385||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.385
71052315|NCT03118570|141609384|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.727||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.727
71052316|NCT03118570|141609384|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.338||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.338
71052317|NCT03118570|141609385|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||< 0.001
71052318|NCT03118570|141609385|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||< 0.001
71052319|NCT03118570|141609385|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||< 0.001
71052320|NCT03118570|141609385|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||< 0.001
71052321|NCT03118570|141609387|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
71052322|NCT03118570|141609387|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
71052323|NCT03118570|141609387|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.08||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||0.080
71052324|NCT03118570|141609387|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.238||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.238
71052325|NCT03118570|141609387|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.238||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.238
71105928|NCT03229538|141718357|SUPERIORITY|It was estimated that 1200 patients (600 per trial group) would provide the trial with more than 90% power to detect superiority of methylprednisolone.|Adjusted Odds Ratio|0.74||||0.428|TWO_SIDED|95.0|0.34|1.57|||Regression, Logistic|||||1.57|0.34|0.428
71105929|NCT03229538|141718358|SUPERIORITY|It was estimated that 1200 patients (600 per trial group) would provide the trial with more than 90% power to detect superiority of methylprednisolone.|Adjusted Odds Ratio|0.83||||0.228|TWO_SIDED|95.0|0.61|1.13|||Regression, Logistic|||||1.13|0.61|0.228
71019012|NCT00883740|141545522|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.81||||0.3841|TWO_SIDED|95.0|-5.92|2.3||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||2.30|-5.92|0.3841
71105930|NCT03229538|141718359|SUPERIORITY|It was estimated that 1200 patients (600 per trial group) would provide the trial with more than 90% power to detect superiority of methylprednisolone over placebo.|Percent Difference|-1.8|||||TWO_SIDED|95.0|-4.0|0.4||||||||0.4|-4.0|
70932108|NCT02307682|141364348|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-4.6|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||6.4|-4.6|
71105931|NCT03229538|141718360|SUPERIORITY|It was estimated that 1200 patients (600 per trial group) would provide the trial with more than 90% power to detect superiority of methylprednisolone over placebo.|Adjusted Odds Ratio|0.79||||0.309|TWO_SIDED|95.0|0.5|1.25|||Regression, Logistic|||||1.25|0.50|0.309
71019013|NCT00883740|141545523|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|25.54|||<|0.0001|TWO_SIDED|95.0|17.48|33.61||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||33.61|17.48|<0.0001
71019014|NCT00883740|141545524|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.42|||<|0.0001|TWO_SIDED|95.0|3.74|7.11||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||7.11|3.74|<0.0001
71019015|NCT00883740|141545525|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.41||||0.0135|TWO_SIDED|95.0|-4.31|-0.51||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||-0.51|-4.31|0.0135
71019016|NCT00883740|141545526|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.53||||0.0008|TWO_SIDED|95.0|-2.41|-0.66||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||-0.66|-2.41|0.0008
71019017|NCT00883740|141545527|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.18||||0.0447|TWO_SIDED|95.0|-14.18|-0.17||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||-0.17|-14.18|0.0447
71019018|NCT00883740|141545528|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.34||||0.3613|TWO_SIDED|95.0|-1.07|0.39||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 1||0.39|-1.07|0.3613
71052326|NCT03118570|141609387|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.035||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.035
71052327|NCT03118570|141609387|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.687||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.687
71052328|NCT03118570|141609387|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.107||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.107
71052329|NCT03118570|141609387|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.128||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.128
71052330|NCT03118570|141609388|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
71052331|NCT03118570|141609388|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
70851253|NCT00669409|141190531|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-10.8|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-27.1|5.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.5|-27.1|
71019019|NCT00883740|141545528|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.0686|TWO_SIDED|95.0|-2.29|0.09||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 2||0.09|-2.29|0.0686
71019020|NCT00883740|141545528|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.44||||0.0009|TWO_SIDED|95.0|-3.85|-1.03||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 3||-1.03|-3.85|0.0009
71052332|NCT03118570|141609388|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.088||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||0.088
71052333|NCT03118570|141609388|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.184||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.184
71052334|NCT03118570|141609388|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.144||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.144
71105932|NCT03229538|141718361|SUPERIORITY|It was estimated that 1200 patients (600 per trial group) would provide the trial with more than 90% power to detect superiority of methylprednisolone over placebo.|Adjusted Odds Ratio|0.91||||0.723|TWO_SIDED|95.0|0.52|1.57|||Regression, Logistic|||||1.57|0.52|0.723
71105933|NCT03229538|141718363|SUPERIORITY||Adjusted Odds Ratio|0.86||||0.256|TWO_SIDED|95.0|0.67|1.11|||Regression, Logistic|||||1.11|0.67|0.256
71019021|NCT00883740|141545528|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.52||||0.0002|TWO_SIDED|95.0|-5.33|-1.71||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 4||-1.71|-5.33|0.0002
71019022|NCT00883740|141545528|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.01||||0.0065|TWO_SIDED|95.0|-5.16|-0.86||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 5||-0.86|-5.16|0.0065
71019023|NCT00883740|141545528|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.89||||0.0024|TWO_SIDED|95.0|-6.36|-1.41||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 6||-1.41|-6.36|0.0024
71019024|NCT00883740|141545528|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.59||||0.0366|TWO_SIDED|95.0|-5.01|-0.16||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 7||-0.16|-5.01|0.0366
71019025|NCT00883740|141545528|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.85||||0.0593|TWO_SIDED|95.0|-5.82|0.11||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 8||0.11|-5.82|0.0593
71019026|NCT00883740|141545529|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.25||||0.1106|TWO_SIDED|95.0|-2.79|0.29||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Quarter 1||0.29|-2.79|0.1106
71019027|NCT00883740|141545529|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.0|||<|0.0001|TWO_SIDED|95.0|-8.49|-3.51||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Quarter 2||-3.51|-8.49|<0.0001
71105934|NCT00862940|141718437|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.04|STANDARD_ERROR_OF_MEAN|1.3||0.9754|TWO_SIDED|95.0|-2.6|2.52|||Mixed Models Analysis|||Linear mixed model relating direct change in brain volume (BBSI) to time and its interaction with treatment group. This model additionally includes a time-by-AChEI group interaction as a fixed effect.||2.52|-2.60|0.9754
71019028|NCT00883740|141545529|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.83||||0.0004|TWO_SIDED|95.0|-10.53|-3.13||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Quarter 3||-3.13|-10.53|0.0004
71019029|NCT00883740|141545529|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.44||||0.0199|TWO_SIDED|95.0|-10.0|-0.88||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Quarter 4||-0.88|-10.00|0.0199
71019030|NCT00883740|141545530|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.14||||0.0024|TWO_SIDED|95.0|0.78|3.5||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||3.50|0.78|0.0024
71019031|NCT00883740|141545531|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.13||||0.0591|TWO_SIDED|95.0|-16.59|0.32||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 5||0.32|-16.59|0.0591
71019032|NCT00883740|141545531|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.81|||<|0.0001|TWO_SIDED|95.0|-27.43|-10.2||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 11||-10.20|-27.43|<0.0001
71019033|NCT00883740|141545532|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.47||||0.1101|TWO_SIDED|95.0|-12.2|1.26||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 5||1.26|-12.20|0.1101
71019034|NCT00883740|141545532|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.39||||0.0002|TWO_SIDED|95.0|-20.36|-6.42||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 11||-6.42|-20.36|0.0002
71105935|NCT00862940|141718438|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.5|STANDARD_ERROR_OF_MEAN|17.52||0.842|TWO_SIDED|95.0|-38.04|31.04|||MMRM|||Mixed model repeated measurements (MMRM) with unstructured covariance including time, time-by-treatment, visit, pre-treatment HCV, and AChEI group.||31.04|-38.04|0.842
71105936|NCT00862940|141718439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68|STANDARD_ERROR_OF_MEAN|0.79||0.034|TWO_SIDED|95.0|0.13|3.23||The p-value represents the difference from placebo for COWAT at Week 52 (MMRM).|MMRM|||||3.23|0.13|0.034
71019035|NCT00883740|141545533|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.91|||<|0.0001|TWO_SIDED|95.0|0.58|1.24||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 1||1.24|0.58|<0.0001
71019036|NCT00883740|141545533|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.14|||<|0.0001|TWO_SIDED|95.0|0.76|1.53||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 2||1.53|0.76|<0.0001
71019037|NCT00883740|141545533|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.87|||<|0.0001|TWO_SIDED|95.0|0.46|1.28||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 3||1.28|0.46|<0.0001
71019038|NCT00883740|141545533|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.89|||<|0.0001|TWO_SIDED|95.0|0.51|1.26||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 4||1.26|0.51|<0.0001
71019039|NCT00883740|141545534|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.66||||0.0001|TWO_SIDED|95.0|-11.44|-3.89||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 1||-3.89|-11.44|0.0001
71019040|NCT00883740|141545534|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.67||||0.0077|TWO_SIDED|95.0|-13.27|-2.07||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 2||-2.07|-13.27|0.0077
71019041|NCT00883740|141545534|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.68||||0.2196|TWO_SIDED|95.0|-14.81|3.44||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 3||3.44|-14.81|0.2196
71019042|NCT00883740|141545534|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.18||||0.0081|TWO_SIDED|95.0|-10.73|-1.64||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 4||-1.64|-10.73|0.0081
71019043|NCT00883740|141545535|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|||<|0.0001|TWO_SIDED|95.0|-1.02|-0.37||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 1||-0.37|-1.02|<0.0001
71019044|NCT00883740|141545535|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.71||||0.0001|TWO_SIDED|95.0|-1.06|-0.36||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 2||-0.36|-1.06|0.0001
71019045|NCT00883740|141545535|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59||||0.0014|TWO_SIDED|95.0|-0.95|-0.24||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 3||-0.24|-0.95|0.0014
71019046|NCT00883740|141545535|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.52||||0.0084|TWO_SIDED|95.0|-0.9|-0.14||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 4||-0.14|-0.90|0.0084
71019047|NCT00883740|141545536|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.27|||<|0.0001|TWO_SIDED|95.0|-27.02|-9.52||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 1||-9.52|-27.02|<0.0001
71052335|NCT03118570|141609388|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.028||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.028
71052336|NCT03118570|141609388|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.694||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.694
71052337|NCT03118570|141609388|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.143||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.143
71052338|NCT03118570|141609388|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.111||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.111
71105937|NCT00862940|141718440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.46||0.602|TWO_SIDED|95.0|-0.67|1.15||The p-value represents the difference from placebo for MMSE at Week 52 (MMRM).|MMRM|||||1.15|-0.67|0.602
70851254|NCT00669409|141190531|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-16.9|15.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||15.7|-16.9|
71019048|NCT00883740|141545536|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.06||||0.0002|TWO_SIDED|95.0|-24.24|-7.87||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 2||-7.87|-24.24|0.0002
71019049|NCT00883740|141545536|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.23||||0.0085|TWO_SIDED|95.0|-23.01|-3.46||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 3||-3.46|-23.01|0.0085
71019050|NCT00883740|141545536|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.25||||0.0102|TWO_SIDED|95.0|-18.01|-2.48||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 4||-2.48|-18.01|0.0102
71052339|NCT03118570|141609389|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
71052340|NCT03118570|141609389|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
70932109|NCT02307682|141364348|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-4.5|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||6.9|-4.5|
70932110|NCT02307682|141364348|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-4.5|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||6.4|-4.5|
71052341|NCT03118570|141609389|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.026||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||0.026
71052342|NCT03118570|141609389|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.007||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.007
71052343|NCT03118570|141609389|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.004||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.004
71052344|NCT03118570|141609389|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.085||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.085
71105938|NCT04533646|141718471|OTHER||Mean Difference (Net)|1.1|||<|0.01|TWO_SIDED||||||Means testing||||comparison of means test was performed|||<0.01
71105939|NCT02581930|141718479|OTHER|Exact binomial test|Probability of response|0.0||||1|ONE_SIDED|||||Significant if p-value is less than 0.1|Exact binomial test, 1-sided||Estimated as proportion of subjects with response|The primary comparison was between the response rate of an ineffective drug, such as investigators' choice chemotherapy (5%), and the response rate of ibrutinib.||||1.00
71105940|NCT02410772|141718513|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavorable status on the control regimen (2HRZE/ 4 HR) and the investigational regimens, Regimen 2 (2HPZ/2HP) and Regimen 3 (2HPZM/2HPM). If the upper bound of the confidence interval is less than , then the non-inferiority of Arm 2 or Arm 3 to Arm 1 with a significance level of 0.05 is established (equivalent to one-sided α=0.025).|Risk Difference (RD)|1.0||||0.05|TWO_SIDED|95.0|-2.6|4.5||For a significance level of 0.05, the statistical test is equivalent to obtaining the two-sided 95% confidence interval for the difference of r\_b-r\_a.|Cochran-Mantel-Haenszel|||For primary efficacy endpoint, unfavorable outcomes for Arm1(control) vs Arm3(2PHZM/2PHM) will be considered first, if non-inferiority criteria are met, then Arm 1 vs Arm 2(2PHZE/2PH) will be compared. The proportion of participants with unfavorable outcome can be estimated as: if r\_a and r\_b are the proportions of unfavorable outcome for the two study arms (a=Arm1 and b = Arm2 or Arm3) and if δ is the non-inferiority margin (=6.6%), statistical hypothesis is H\_0:r\_b-r\_a≥δ vs.H\_1:r\_b-r\_a\<δ||4.5|-2.6|0.05
70932111|NCT02307682|141364348|OTHER||Difference in proportions|2.8|||||TWO_SIDED|95.0|-3.1|8.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||8.7|-3.1|
71052345|NCT03118570|141609389|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.04||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.040
71052346|NCT03118570|141609389|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.061||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.061
71052347|NCT03118570|141609389|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.189||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.189
70851255|NCT00669409|141190531|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-23.9|8.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.4|-23.9|
71052348|NCT03118570|141609390|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
71052349|NCT03118570|141609390|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
71052350|NCT03118570|141609390|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.035||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||0.035
71052351|NCT03118570|141609390|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.003||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.003
71117606|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
71019051|NCT00883740|141545537|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|24.82|||<|0.0001|TWO_SIDED|95.0|13.25|36.4||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 1||36.40|13.25|<0.0001
71019052|NCT00883740|141545537|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29.4|||<|0.0001|TWO_SIDED|95.0|18.59|40.21||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 2||40.21|18.59|<0.0001
71019053|NCT00883740|141545537|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|26.79|||<|0.0001|TWO_SIDED|95.0|15.37|38.21||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 3||38.21|15.37|<0.0001
71019054|NCT00883740|141545537|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|25.44|||<|0.0001|TWO_SIDED|95.0|15.03|35.86||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 4||35.86|15.03|<0.0001
71052352|NCT03118570|141609390|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.003||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.003
71052353|NCT03118570|141609390|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.088||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.088
71052354|NCT03118570|141609390|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.016||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.016
71052355|NCT03118570|141609390|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.068||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.068
71052356|NCT03118570|141609390|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.16||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.160
71052357|NCT03118570|141609391|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.065||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.065
71019055|NCT00390949|141545544|SUPERIORITY||||||<|0.05||||||The p-value reported above is not simply a statement of the threshold for significance used in the study. The p-value for this comparison was calculated at the time of the study and was found to be less than 0.5.|Regression, Logistic|Adjustments for community pair, age-group and value of variable at baseline||||||<0.05
71019056|NCT00390949|141545545|SUPERIORITY||||||<|0.05||||||The p-value reported above is not simply a statement of the threshold for significance used in the study. The p-value for this comparison was calculated at the time of the study and was found to be less than 0.5.|Regression, Logistic|Adjusted for community pair, age-group and value of variable at baseline||||||<0.05
71052358|NCT03118570|141609391|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.405||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.405
71052359|NCT03118570|141609391|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.966||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.966
71052360|NCT03118570|141609391|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.003||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.003
71052361|NCT03118570|141609391|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.229||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.229
71052362|NCT03118570|141609391|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.807||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.807
71052363|NCT03118570|141609391|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.042||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.042
71052364|NCT03118570|141609391|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.283||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.283
70932112|NCT02307682|141364348|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-4.7|7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||7.2|-4.7|
71019057|NCT00390949|141545546|SUPERIORITY||||||<|0.05||||||The p-value reported above is not simply a statement of the threshold for significance used in the study. The p-value for this comparison was calculated at the time of the study and was found to be less than 0.5.|Regression, Logistic|||||||<0.05
71019058|NCT00390949|141545547|SUPERIORITY||||||<|0.05||||||The p-value reported above is not simply a statement of the threshold for significance used in the study. The p-value for this comparison was calculated at the time of the study and was found to be less than 0.5.|Regression, Logistic|Adjusted for community pair, age-group and value at baseline||||||<0.05
71019059|NCT00390949|141545548|SUPERIORITY||||||<|0.05||||||The p-value reported above is not simply a statement of the threshold for significance used in the study. The p-value for this comparison was calculated at the time of the study and was found to be less than 0.5.|Regression, Logistic|Adjusted for community pair and age-group||||||<0.05
70932113|NCT02307682|141364349|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-7.7|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.5|-7.7|
71019060|NCT00390949|141545549|SUPERIORITY||||||<|0.05||||||The p-value reported above is not simply a statement of the threshold for significance used in the study. The p-value for this comparison was calculated at the time of the study and was found to be less than 0.5.|Regression, Logistic|Adjusted for community pair, age-group and value at baseline||||||<0.05
71019061|NCT04840901|141545593|EQUIVALENCE|PK parameters were powered to test equivalence with a power of 90% that the 90% confidence interval (CI) of the geometric mean ratio fall within 0.8 to 1.25 equivalence margin.|Ratio of Geometric LS Mean|1.09|||||TWO_SIDED|90.0|1.03|1.16|||ANCOVA|||||1.16|1.03|
71019062|NCT04840901|141545594|EQUIVALENCE|PK parameters were powered to test equivalence with a power of 90% that the 90% confidence interval (CI) of the geometric mean ratio fall within 0.8 to 1.25 equivalence margin.|Ratio of Geometric LS Mean|1.07|||||TWO_SIDED|90.0|1.02|1.14|||ANCOVA|||||1.14|1.02|
71019063|NCT04840901|141545595|EQUIVALENCE|PK parameters were powered to test equivalence with a power of 90% that the 90% confidence interval (CI) of the geometric mean ratio fall within 0.8 to 1.25 equivalence margin.|Ratio of Geometric LS Mean|1.09|||||TWO_SIDED|90.0|1.03|1.14|||ANCOVA|||||1.14|1.03|
71019064|NCT05354206|141545597|SUPERIORITY||Mean Difference (Final Values)|0.405|STANDARD_DEVIATION|0.285|<|0.05|TWO_SIDED|||||p-values have not been adjusted for multiple comparisons|t-test, 2 sided||Difference of RST from 1 for hip range of motion task without stimulation.|"Reticulospinal tract (RST) contribution computed as RST = (visual - startle)/(visual - auditory) reaction times, where a RST value greater than 1 would indicate a significant contribution of the reticulospinal tract for a given task.~A one sample t-test (or Wilcoxon signed-rank test for non-normally distributed data) was used to test the hypothesis that the RST contribution for a given movement was significantly greater than 1."||||<0.05
71019065|NCT04936334|141545602|SUPERIORITY||McNemar|0.03|||<|0.05|TWO_SIDED||||||McNemar|||||||<0.05
71019066|NCT02209272|141545625|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||||||0.82
71019067|NCT02209272|141545626|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||||||0.21
71019068|NCT02209272|141545627|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||||||0.57
71019069|NCT01336608|141545763|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.01||||0.969|TWO_SIDED|95.0|-0.71|0.74|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)||||0.74|-0.71|0.969
71019070|NCT01336608|141545763|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.22||||0.568|TWO_SIDED|95.0|-0.53|0.96|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)||||0.96|-0.53|0.568
71019071|NCT01336608|141545763|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.2||||0.566|TWO_SIDED|95.0|-0.49|0.89|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)||||0.89|-0.49|0.566
71019072|NCT01336608|141545764|SUPERIORITY_OR_OTHER||Least squares mean difference|0.082||||0.007|TWO_SIDED|95.0|0.023|0.141||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.141|0.023|0.007
71019073|NCT01336608|141545764|SUPERIORITY_OR_OTHER||Least squares mean difference|0.155|||<|0.001|TWO_SIDED|95.0|0.095|0.215||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.215|0.095|<0.001
71019074|NCT01336608|141545764|SUPERIORITY_OR_OTHER||Least squares mean difference|0.074||||0.012|TWO_SIDED|95.0|0.016|0.131||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.131|0.016|0.012
71019075|NCT01336608|141545765|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.72|-0.22||Nominal p-value|ANCOVA|||||-0.22|-0.72|<0.001
71019076|NCT01336608|141545765|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.5|||<|0.001|TWO_SIDED|95.0|-0.76|-0.24||Nominal p-value|ANCOVA|||||-0.24|-0.76|<0.001
71019077|NCT01336608|141545765|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.03||||0.803|TWO_SIDED|95.0|-0.29|0.22|||ANCOVA|||||0.22|-0.29|0.803
71019078|NCT00080288|141545766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|||<|0.0001||95.0|1.67|3.69|||ANCOVA|||Assumption: both primary treatment comparisons would be with a 2 sided test at an alpha level of 0.05.||3.69|1.67|<0.0001
71019079|NCT00080288|141545767|SUPERIORITY_OR_OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|The p value for each treatment group is for the comparison of that treatment group to the placebo treatment group. Adjusted for country.||Assumption: both primary treatment comparisons would be with a 2 sided test at an alpha level of 0.05.||||0.0010
71019080|NCT01143272|141545816|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.94|TWO_SIDED|95.0|0.55|1.9|||Regression, Cox|||||1.90|0.55|0.94
71019081|NCT01143272|141545816|SUPERIORITY_OR_OTHER|||||||0.25|||||||Fisher Exact|||||||0.25
71019082|NCT01143272|141545816|SUPERIORITY_OR_OTHER|||||||0.87|||||||Log Rank|||||||0.87
71019083|NCT01143272|141545818|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.8|TWO_SIDED|95.0|0.49|1.73|||Regression, Cox|||||1.73|0.49|0.80
70932114|NCT02307682|141364349|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-8.5|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||2.8|-8.5|
70932115|NCT02307682|141364349|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-8.9|2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||2.6|-8.9|
71019084|NCT01143272|141545818|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.93|TWO_SIDED|95.0|0.53|2.03||adjusting for age, sex, CRP, leukocyte count, duration of antibiotic treatment, and administration of antibiotics|Regression, Cox|||||2.03|0.53|0.93
71019085|NCT01143272|141545819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.6|TWO_SIDED|95.0|0.96|1.08||Association between initial leukocyte count and incidence of AAD|Regression, Logistic|||||1.08|0.96|0.6
71019086|NCT01143272|141545819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.653|TWO_SIDED|95.0|1.0|1.01||Association between the initial C-reactive protein and incidence of AAD|Regression, Logistic|||||1.01|1.00|0.653
71019087|NCT00545181|141545836|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||Chi-squared, Corrected|||||||0.75
71019088|NCT00149669|141545848|SUPERIORITY||Odds Ratio (OR)|8.67|||<|0.01|TWO_SIDED|95.0|4.24|17.73|||General Estimating Equation (GEE)|||||17.73|4.24|<0.01
71019089|NCT00149669|141545849|SUPERIORITY||Odds Ratio (OR)|0.91||||0.82|TWO_SIDED|95.0|0.43|1.95|||General Estimating Equation (GEE)|||||1.95|.43|0.82
71052365|NCT03118570|141609391|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.536||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.536
71052366|NCT03118570|141609391|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.765||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.765
71052367|NCT03118570|141609391|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.247||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.247
71052368|NCT03118570|141609391|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.05||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.050
71052369|NCT03118570|141609391|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.037||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.037
71052370|NCT03118570|141609391|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.174||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.174
71052371|NCT03118570|141609391|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.558||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.558
71019090|NCT00149669|141545850|SUPERIORITY||Odds Ratio (OR)|0.61|||=|0.19|TWO_SIDED|95.0|0.29|1.26|||General Estimating Equation (GEE)|||||1.26|0.29|=0.19
71019091|NCT02458365|141545855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.51|0.75|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.75|.51|<.0001
71019092|NCT02458365|141545855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55|||<|0.0001|TWO_SIDED|95.0|0.45|0.68|||Regression, Linear|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.68|.45|<.0001
71019093|NCT02458365|141545856|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||<|0.001|TWO_SIDED|95.0|0.57|0.84|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.84|.57|<.001
71019094|NCT02458365|141545856|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.5|0.75|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.75|.50|<.0001
71019095|NCT02458365|141545857|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.43|0.67|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.67|.43|<.0001
71019096|NCT02458365|141545857|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.36|0.56|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.56|.36|<.0001
71052372|NCT03118570|141609391|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.02||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.020
71052373|NCT03118570|141609391|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.346||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.346
71052374|NCT03118570|141609391|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.387||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.387
70851256|NCT00669409|141190531|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.8|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-37.1|5.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.4|-37.1|
71019097|NCT02458365|141545858|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.41|0.62|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.62|.41|<.0001
70851257|NCT00669409|141190532|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|11.4|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-5.1|27.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||27.9|-5.1|
70851258|NCT00669409|141190532|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.1|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-24.4|8.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.2|-24.4|
70851259|NCT00669409|141190532|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-14.2|18.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||18.4|-14.2|
71019098|NCT02458365|141545858|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.35|0.54|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.54|.35|<.0001
71019099|NCT02458365|141545859|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55||||0.001|TWO_SIDED|95.0|0.38|0.78|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.78|.38|.001
71019100|NCT02458365|141545859|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||0.013|TWO_SIDED|95.0|0.4|0.9|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.90|.40|.013
71019101|NCT02458365|141545860|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53|||<|0.001|TWO_SIDED|95.0|0.37|0.76|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.76|.37|<.001
71019102|NCT02458365|141545860|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.54||||0.004|TWO_SIDED|95.0|0.35|0.82|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.82|.35|.004
71019103|NCT02458365|141545861|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53||||0.002|TWO_SIDED|95.0|0.35|0.78|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.78|.35|.002
71019104|NCT02458365|141545861|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5||||0.005|TWO_SIDED|95.0|0.31|0.81|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.81|.31|.005
71019105|NCT02458365|141545862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43|||<|0.0001|TWO_SIDED|95.0|0.29|0.64|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.64|.29|<.0001
71019106|NCT02458365|141545862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.003|TWO_SIDED|95.0|0.29|0.77|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.77|.29|.003
71019107|NCT02413879|141545881|SUPERIORITY||||||<|0.001|||||||McNemar|||||||<0.001
71019108|NCT02413879|141545883|SUPERIORITY||||||<|0.001|||||||McNemar|||||||<0.001
71019109|NCT01227954|141545899|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||To detect a minimum relative 50% improvement leading to an absolute 15% mean relative decline (MRD) in HVLT-R DR, 51 analyzable patients were required to ensure 80% statistical power with 0.05 alpha. Assuming a death rate of 40% before 4 months (based on trial NCT00003563) and a 10% nonevaluable rate, the target sample size was 102. The target MRD was determined from NCT00003563 which demonstrated 30% MRD in HVLT-R DR score from baseline to 4 months, with a standard deviation of 41%.||||<0.001
71019110|NCT01227954|141545902|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with FACT-Br total score (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and recursive partitioning analysis class (RPA) (I vs. II). Explanatory variables are reported separately and only if in the final model (p\< 0.10, except time forced in the model.). Intercept is reported here.||||<0.0001
70932116|NCT02307682|141364349|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-7.7|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||3.6|-7.7|
71019111|NCT01227954|141545902|SUPERIORITY|||||||0.1961|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with FACT-Br total score (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Time is reported here.||||0.1961
71019112|NCT01227954|141545902|SUPERIORITY|||||||0.0715|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with FACT-Br total score (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Primary site (lung) is reported here.||||0.0715
71019113|NCT01227954|141545902|SUPERIORITY|||||||0.0554|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model with FACT-Br total score (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Neurologic status (no symptoms) is reported here.||||0.0554
71019114|NCT01227954|141545903|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with ADL (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Intercept is reported here.||||<0.0001
71019115|NCT01227954|141545903|SUPERIORITY|||||||0.1579|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with ADL (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Time is reported here.||||0.1579
71019116|NCT01227954|141545903|SUPERIORITY|||||||0.0559|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with ADL (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Neurologic function status (some symptoms) is reported here.||||0.0559
71019117|NCT01227954|141545903|SUPERIORITY|||||||0.0749|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with ADL (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Age (\>= 60) is reported here.||||0.0749
71019118|NCT03583931|141545954|SUPERIORITY|||||||0.61|||||||ANOVA|||||||0.61
71019119|NCT03583931|141545955|SUPERIORITY|||||||0.84|||||||ANOVA|||||||0.84
71019120|NCT03583931|141545960|SUPERIORITY|||||||0.48|||||||ANOVA|||||||0.48
71019121|NCT03583931|141545961|SUPERIORITY|||||||0.25|||||||ANOVA|||||||0.25
71019122|NCT03583931|141545962|SUPERIORITY|||||||0.45|||||||ANOVA|||||||0.45
71019123|NCT03583931|141545963|SUPERIORITY|||||||0.87|||||||ANOVA|||||||0.87
71052375|NCT03118570|141609391|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.093||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.093
71019124|NCT02787785|141545965|SUPERIORITY||Cox Proportional Hazard|0.49||||0.354|TWO_SIDED|95.0|0.11|2.2|||Regression, Cox|||||2.20|0.11|0.354
71019125|NCT02787785|141545967|SUPERIORITY||Cox Proportional Hazard|0.37||||0.479|TWO_SIDED|95.0|0.02|5.88|||Regression, Cox|||||5.88|0.02|0.479
71019126|NCT00110084|141545980|SUPERIORITY_OR_OTHER||Proportion of confirmed responses (%)|50.0|||||TWO_SIDED|95.0|36.0|64.0|||||95% Confidence intervals were calculated for the true confirmed response rate using properties of the binomial distribution.|Proportion of confirmed responses was estimated by the number of patients who achieved a confirmed response divided by the total number of assessable patients.||64|36|
71019127|NCT04101721|141545994|NON_INFERIORITY|Non-inferiority margin is 5%|Adjusted difference|1.81|||||TWO_SIDED|95.1|-15.71|19.33||||||Difference with confidence interval (CI) is calculated using Mantel-Haenszel weighting scheme adjusted by baseline ROP status.||19.33|-15.71|
71019128|NCT04101721|141545995|SUPERIORITY||Adjusted difference|-3.66|||||TWO_SIDED|95.1|-19.86|12.54||||||Difference with confidence interval (CI) is calculated using Mantel-Haenszel weighting scheme adjusted by baseline ROP status.||12.54|-19.86|
71019129|NCT04101721|141545996|SUPERIORITY||Adjusted difference|10.1|||||TWO_SIDED|95.1|-9.83|30.02||||||Difference with confidence interval (CI) is calculated using Mantel-Haenszel weighting scheme adjusted by baseline ROP status||30.02|-9.83|
71052376|NCT03118570|141609391|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.156||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.156
71019130|NCT00535301|141546052|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.24|STANDARD_DEVIATION|2.0||0.005|TWO_SIDED|95.0|0.1|0.6|||Chi-squared|||Sample size was calculated based on previously-published anatomic success rates of standard anterior colporrhaphy (50%) and polypropylene mesh-reinforced anterior vaginal repair (85%) (1-10). Assuming a 2-sided hypothesis test with 5% type I error and 80% power, 33 patients in each group would be required to detect an absolute difference of 35% or more in recurrent stage II prolapse. Assuming a 15% drop-out rate, we sought to enroll 76 patients into the clinical trial.||0.6|0.1|0.005
71019131|NCT00535301|141546053|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5
71019132|NCT00535301|141546054|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
71019133|NCT05144477|141546070|OTHER|Proportion of referrals who provided consent and enrolled into the study was calculated.|Proportion|0.64|||||TWO_SIDED|95.0|0.425|0.82||||||||0.820|0.425|
71019134|NCT05144477|141546071|OTHER|Proportion of enrolled participants who remained in the study at 30 days after the end of hospital care was calculated.|Proportion|0.875|||||TWO_SIDED|95.0|0.617|0.985||||||||0.985|0.617|
71019135|NCT05144477|141546072|OTHER|Proportion of participants randomized to the FAID Fear Diary Intervention who wrote in the diary at least twice per week up until the end of hospital care was calculated.|Proportion|0.636|||||TWO_SIDED|95.0|0.308|0.891||||||||0.891|0.308|
71019136|NCT05144477|141546073|OTHER|Proportion of enrolled participants who provided complete data for at least 90% of all study assessments was calculated.|Proportion|0.875|||||TWO_SIDED|95.0|0.617|0.985||||||||0.985|0.617|
71019137|NCT05144477|141546074|OTHER|Proportion of intervention participants who agreed that the ICU diary was acceptable for reducing fear about their loved one's heart was calculated.|Proportion|0.8|||||TWO_SIDED|95.0|0.444|0.975||||||||0.975|0.444|
71019138|NCT05144477|141546075|OTHER|Proportion of intervention participants who agreed that the ICU diary was feasible for reducing fear about their loved one's heart was calculated.|Proportion|0.9|||||TWO_SIDED|95.0|0.555|0.998||||||||0.998|0.555|
71019139|NCT05144477|141546076|OTHER|Proportion of intervention participants who agreed that the ICU diary was appropriate for reducing fear about their loved one's heart was calculated.|Proportion|0.7|||||TWO_SIDED|95.0|0.348|0.933||||||||0.933|0.348|
71019140|NCT05144477|141546077|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.63|TWO_SIDED|95.0|-0.83|1.32|||t-test, 2 sided|||Outcome analysis at the end of hospital care.||1.32|-0.83|.63
71019141|NCT05144477|141546077|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.86|TWO_SIDED|95.0|-0.92|1.08|||t-test, 2 sided|||Outcome analysis for 30 days after the end of hospital care.||1.08|-0.92|.86
71019142|NCT05144477|141546078|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.86|TWO_SIDED|95.0|-1.43|1.21|||t-test, 2 sided|||Outcome analysis for the end of hospital care.||1.21|-1.43|.86
71019143|NCT05144477|141546078|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.75|TWO_SIDED|95.0|-1.1|1.58|||t-test, 2 sided|||Outcome analysis for 30 days after the end of hospital care.||1.58|-1.10|.75
71019144|NCT05144477|141546079|SUPERIORITY||Mean Difference (Final Values)|-8.7||||0.22|TWO_SIDED|95.0|-23.26|5.86|||t-test, 2 sided|||||5.86|-23.26|.22
71019145|NCT05144477|141546079|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)||||χ2(1) = 1.29|||.26
71019146|NCT05144477|141546079|SUPERIORITY|||||||1|||||||Fisher Exact|||A Fisher's Exact Test was conducted to compare the number of participants with a positive screen for PTSD symptoms (score \>=33) to those who did not have a positive screen for PTSD symptoms (score \< 33).||||1.00
71019147|NCT03111407|141546083|EQUIVALENCE|Data analyzed with SAS Enterprise Guided (version 7.15 HF3, SAS lnstitute lnc., Cary, NC). Significance level set with q = 0.05. Continuous data (e.g. age, weight, EQ-5D) were summarized using mean, standard deviation, minimum, median, maximum and number of observations. Comparison between continuous baseline and patient visits were performed using standard statistical tests (e.g., a t-test, Wilcoxon test, or one-way ANOVA (as appropriate) were performed as required to evaluate the difference).||||||0.2342|||||||t-test, 2 sided|||"Hip Knee Angle value 1 year post surgery: Mean+/- SD (N)(Min, Max) 95%C.I (lower, upper)~iAssist group: 179.9 +/-2.9 (44) (171, 185.3)~Conventional group: 178.9 +/-3.9 (26) (167, 185)"||||0.2342
71019148|NCT03111407|141546084|EQUIVALENCE|Data analyzed with SAS Enterprise Guided (version 7.15 HF3, SAS lnstitute lnc., Cary, NC). Significance level set with q = 0.05. Continuous data (e.g. age, weight, EQ-5D) were summarized using mean, standard deviation, minimum, median, maximum and number of observations. Comparison between continuous baseline and patient visits were performed using standard statistical tests (e.g., a t-test, Wilcoxon test, or one-way ANOVA (as appropriate) were performed as required to evaluate the difference).||||||0.4427|||||||t-test, 2 sided|||"Knee Society Score Assessment 1 year post surgery: Mean+/- SD (N)(Min, Max) 95%C.I (lower, upper)~iAssist group: 74.7 +/- 12.5 \[44\] (30.2, 78.0, 89.5), 95% C.I. (70.9, 78.5)~Conventional group: 72.4 +/- 11.6 \[26\] (45.0, 75.2, 90.1), 95% C.I. (67.7, 77.1)"||||0.4427
71019149|NCT03111407|141546085|EQUIVALENCE|Data analyzed with SAS Enterprise Guided (version 7.15 HF3, SAS lnstitute lnc., Cary, NC). Significance level set with q = 0.05. Continuous data (e.g. age, weight, EQ-5D) were summarized using mean, standard deviation, minimum, median, maximum and number of observations. Comparison between continuous baseline and patient visits were performed using standard statistical tests (e.g., a t-test, Wilcoxon test, or one-way ANOVA (as appropriate) were performed as required to evaluate the difference).||||||0.6154|||||||t-test, 2 sided|||Knee Soceity Score Function 1 year post surgery: Mean+/- SD (N)(Min, Max) 95%C.I (lower, upper) iAssist group: 80.5 +/- 13.8 \[44\] (55.0, 80.0, 100.0), 95% C.I. (76.2, 84.7) Conventional group: 78.5 +/- 19.1 \[26\] (40.0, 80.0, 100.0),95% C.I. (70.8, 86.2)||||0.6154
71019150|NCT03111407|141546086|EQUIVALENCE|Data analyzed with SAS Enterprise Guided (version 7.15 HF3, SAS lnstitute lnc., Cary, NC). Significance level set with q = 0.05. Continuous data (e.g. age, weight, EQ-5D) were summarized using mean, standard deviation, minimum, median, maximum and number of observations. Comparison between continuous baseline and patient visits were performed using standard statistical tests (e.g., a t-test, Wilcoxon test, or one-way ANOVA (as appropriate) were performed as required to evaluate the difference).||||||0.4549|||||||t-test, 2 sided|||EQ-5D score 1 year post surgery: Mean+/- SD (N)(Min, Max) 95%C.I (lower, upper) iAssist group: 0.8 +/- 0.2 \[29\] (0.0, 1.0, 1.0), 95% C.I. (0.7, 0.9) Conventional group: 0.8 +/- 0.3 \[20\] (0.1, 0.8, 1.0), 95% C.I. (0.7, 0.9)||||0.4549
71019151|NCT02268045|141546087|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The RR, with the corresponding 95% CI, was calculated for each treatment arm and compared using Fisher's exact test at a one-sided 0.025 type I error rate. A non-inferiority margin of 13% was assumed with ≥ 80% power to detect treatment differences. Non-inferiority was concluded if the one-sided 95% CI was above the -13% margin set for the study.|Percentage difference|0.7|||||ONE_SIDED|95.0|-13.0||||||For the ITT population||||-13|
70932117|NCT02307682|141364349|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-8.9|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.4|-8.9|
70932118|NCT02307682|141364349|OTHER||Difference in proportions|-4.0|||||TWO_SIDED|95.0|-10.0|2.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.0|-10.0|
71052377|NCT03118570|141609391|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.324||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.324
71052378|NCT03118570|141609391|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.92||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.920
71052379|NCT03118570|141609391|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.04||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.040
70932119|NCT02307682|141364349|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-6.3|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||5.5|-6.3|
71117607|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
70932120|NCT02307682|141364349|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-6.2|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||6.4|-6.2|
70932121|NCT02307682|141364349|OTHER||Difference in proportions|-4.0|||||TWO_SIDED|95.0|-10.4|2.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||2.0|-10.4|
70932122|NCT02307682|141364349|OTHER||Difference in proportions|-3.4|||||TWO_SIDED|95.0|-9.4|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||2.8|-9.4|
70932123|NCT02307682|141364349|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-4.6|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||6.9|-4.6|
70932124|NCT02307682|141364349|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-6.6|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||5.7|-6.6|
70932125|NCT02307682|141364349|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-6.5|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||5.7|-6.5|
70932126|NCT02307682|141364349|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-4.9|7.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||7.4|-4.9|
70932127|NCT02307682|141364349|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-3.9|7.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||7.5|-3.9|
70932128|NCT02307682|141364349|OTHER||Difference in proportions|5.1|||||TWO_SIDED|95.0|-1.0|11.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||11.5|-1.0|
71052380|NCT03118570|141609391|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.643||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.643
71052381|NCT03118570|141609392|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.285||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.285
71105941|NCT02410772|141718513|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavorable status on the control regimen (2HRZE/ 4 HR) and the investigational regimens, Regimen 2 (2HPZ/2HP) and Regimen 3 (2HPZM/2HPM). If the upper bound of the confidence interval is less than , then the non-inferiority of Arm 2 or Arm 3 to Arm 1 with a significance level of 0.05 is established (equivalent to one-sided α=0.025).|Risk Difference (RD)|3.0||||0.05|TWO_SIDED|95.0|-0.6|6.6|||Cochran-Mantel-Haenszel|For a significance level of 0.05, the statistical test is equivalent to obtaining the two-sided 95% confidence interval for the difference of r\_b-r\_a.||For primary efficacy endpoint, unfavorable outcomes for Arm1(control) vs Arm3(2PHZM/2PHM) will be considered first, if non-inferiority criteria are met, then Arm 1 vs Arm 2(2PHZE/2PH) will be compared. The proportion of participants with unfavorable outcome can be estimated as: if r\_a and r\_b are the proportions of unfavorable outcome for the two study arms (a=Arm1 and b = Arm2 or Arm3) and if δ is the non-inferiority margin (=6.6%), statistical hypothesis is H\_0:r\_b-r\_a≥δ vs.H\_1:r\_b-r\_a\<δ||6.6|-0.6|0.05
71105942|NCT02410772|141718514|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavorable status on the control regimen (2HRZE/ 4 HR) and the investigational regimens, Regimen 2 (2HPZ/2HP) and Regimen 3 (2HPZM/2HPM). If the upper bound of the confidence interval is less than , then the non-inferiority of Arm 2 or Arm 3 to Arm 1 with a significance level of 0.05 is established (equivalent to one-sided α=0.025).|Risk Difference (RD)|2.0||||0.05|TWO_SIDED|95.0|-1.1|5.1||For a significance level of 0.05, the statistical test is equivalent to obtaining the two-sided 95% confidence interval for the difference of r\_b-r\_a|Cochran-Mantel-Haenszel|||For primary efficacy endpoint, unfavorable outcomes for Arm1(control) vs Arm3(2PHZM/2PHM) will be considered first, if non-inferiority criteria are met, then Arm 1 vs Arm 2(2PHZE/2PH) will be compared. The proportion of participants with unfavorable outcome can be estimated as: if r\_a and r\_b are the proportions of unfavorable outcome for the two study arms (a=Arm1 and b = Arm2 or Arm3) and if δ is the non-inferiority margin (=6.6%), statistical hypothesis is H\_0:r\_b-r\_a≥δ vs.H\_1:r\_b-r\_a\<δ||5.1|-1.1|0.05
71105943|NCT02410772|141718514|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavorable status on the control regimen (2HRZE/ 4 HR) and the investigational regimens, Regimen 2 (2HPZ/2HP) and Regimen 3 (2HPZM/2HPM). If the upper bound of the confidence interval is less than , then the non-inferiority of Arm 2 or Arm 3 to Arm 1 with a significance level of 0.05 is established (equivalent to one-sided α=0.025).|Risk Difference (RD)|4.4||||0.05|TWO_SIDED|95.0|1.2|7.7||For a significance level of 0.05, the statistical test is equivalent to obtaining the two-sided 95% confidence interval for the difference of r\_b-r\_a|Cochran-Mantel-Haenszel|||For primary efficacy endpoint, unfavorable outcomes for Arm1(control) vs Arm3(2PHZM/2PHM) will be considered first, if non-inferiority criteria are met, then Arm 1 vs Arm 2(2PHZE/2PH) will be compared. The proportion of participants with unfavorable outcome can be estimated as: if r\_a and r\_b are the proportions of unfavorable outcome for the two study arms (a=Arm1 and b = Arm2 or Arm3) and if δ is the non-inferiority margin (=6.6%), statistical hypothesis is H\_0:r\_b-r\_a≥δ vs.H\_1:r\_b-r\_a\<δ||7.7|1.2|0.05
71105944|NCT02410772|141718515|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavorable status on the control regimen (2HRZE/ 4 HR) and the investigational regimens, Regimen 2 (2HPZ/2HP) and Regimen 3 (2HPZM/2HPM). If the upper bound of the confidence interval is less than, then the non-inferiority of Arm 2 or Arm 3 to Arm 1 with a significance level of 0.05 is established (equivalent to one-sided α=0.025).|Risk Difference (RD)|-0.6||||0.05|TWO_SIDED|95.0|-4.3|3.2||For a significance level of 0.05, the statistical test is equivalent to obtaining the two-sided 95% confidence interval for the difference of r\_b-r\_a.|Cochran-Mantel-Haenszel|||For primary Safety endpoint, unfavorable outcomes for Arm1(control) vs Arm3(2PHZM/2PHM) will be considered first, if non-inferiority criteria are met, then Arm 1 vs Arm 2(2PHZE/2PH) will be compared. The proportion of participants with unfavorable outcome can be estimated as: if r\_a and r\_b are the proportions of unfavorable outcome for the two study arms (a=Arm1 and b = Arm2 or Arm3) and if δ is the non-inferiority margin (=6.6%), statistical hypothesis is H\_0:r\_b-r\_a≥δ vs.H\_1:r\_b-r\_a\<δ||3.2|-4.3|0.05
71117608|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
70932129|NCT02307682|141364349|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.5|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||3.4|-8.5|
70932130|NCT02307682|141364349|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-6.0|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||6.4|-6.0|
70932131|NCT02307682|141364349|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-5.2|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||6.4|-5.2|
70932132|NCT02307682|141364349|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-7.4|5.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||5.0|-7.4|
70851260|NCT00669409|141190532|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.1|STANDARD_ERROR_OF_MEAN|8.16|||TWO_SIDED|95.0|-24.3|8.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.0|-24.3|
71117609|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
70932133|NCT02307682|141364349|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.8|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||3.5|-8.8|
71019152|NCT02268045|141546087|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The RR, with the corresponding 95% CI, was calculated for each treatment arm and compared using Fisher's exact test at a one-sided 0.025 type I error rate. A non-inferiority margin of 13% was assumed with ≥ 80% power to detect treatment differences. Non-inferiority was concluded if the one-sided 95% CI was above the -13% margin set for the study.|percentage difference|3.0|||||ONE_SIDED|95.0|-13.0||||||For the PP population||||-13|
71019153|NCT02268045|141546088|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%-125%.|ratio RTXM83 to Mabthera|99.2|||||TWO_SIDED|90.0|93.6|105.0|||||For the ratio: RTXM83 represents the numerator and Mabthera the denominator|||105|93.6|
71019154|NCT02268045|141546089|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%-125%.|ratio RTXM83 to Mabthera|103.0|||||TWO_SIDED|90.0|98.5|107.0|||||For the ratio: RTXM83 represents the numerator and Mabthera the denominator|||107|98.5|
71019155|NCT02268045|141546090|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%-125%.|ratio RTXM83 to Mabthera|99.6|||||TWO_SIDED|90.0|93.9|105.0|||||For the ratio: RTXM83 represents the numerator and Mabthera the denominator|||105|93.9|
71019156|NCT02268045|141546091|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%-125%.|ratio RTXM83 to Mabthera|104.0|||||TWO_SIDED|90.0|99.5|109.0|||||For the ratio: RTXM83 represents the numerator and Mabthera the denominator|||109|99.5|
71019157|NCT02268045|141546095|OTHER|||||||0.457|||||||Log Rank|||||||0.4570
71019158|NCT01154673|141546096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.056|TWO_SIDED|95.0|-0.006|0.4||"The estimated difference in mean change from baseline to 48 weeks was calculated as the log DNA copies/106 CD4+ T cells in Intensive HAART minus the log DNA copies/106 CD4+ T cells in Placebo Arm"|Regression, Linear||"The estimated difference in mean change from baseline to 48 weeks was calculated as the log DNA copies/106 CD4+ T cells in Intensive HAART minus the log DNA copies/106 CD4+ T cells in Placebo Arm"|||0.4|-.006|0.056
71019159|NCT01289990|141546098|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.94|-0.64||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||statistical analysis at week 52||-0.64|-0.94|<0.0001
71019160|NCT01289990|141546098|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.91|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-1.06|-0.76||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||statistical analysis at week 52||-0.76|-1.06|<0.0001
71019161|NCT01289990|141546098|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.82|-0.52||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||statistical analysis at week 52||-0.52|-0.82|<0.0001
71019162|NCT01289990|141546098|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.08||0.1245|TWO_SIDED|95.0|-0.27|0.03||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||statistical analysis at week 52||0.03|-0.27|0.1245
71019163|NCT01289990|141546098|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.08||0.0022|TWO_SIDED|95.0|-0.39|-0.09||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||statistical analysis at week 52||-0.09|-0.39|0.0022
71019164|NCT01289990|141546098|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.79|-0.41||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.41|-0.79|<0.0001
71019165|NCT01289990|141546098|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.68|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.87|-0.49||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.49|-0.87|<0.0001
71019166|NCT01289990|141546098|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.62|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.75|-0.48||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.48|-0.75|<0.0001
71019167|NCT01289990|141546098|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.83|-0.55||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.55|-0.83|<0.0001
71019168|NCT01289990|141546098|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.74|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.89|-0.59||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.59|-0.89|<0.0001
71117610|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
71052382|NCT03118570|141609392|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.544||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.544
71019169|NCT01289990|141546098|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.85|-0.55||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.55|-0.85|<0.0001
71019170|NCT01289990|141546099|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.04|-0.61||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.61|-1.04|<0.0001
71052383|NCT03118570|141609392|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.615||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.615
71052384|NCT03118570|141609392|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.179||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.179
71105945|NCT02410772|141718515|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavorable status on the control regimen (2HRZE/ 4 HR) and the investigational regimens, Regimen 2 (2HPZ/2HP) and Regimen 3 (2HPZM/2HPM). If the upper bound of the confidence interval is less than, then the non-inferiority of Arm 2 or Arm 3 to Arm 1 with a significance level of 0.05 is established (equivalent to one-sided α=0.025).|Risk Difference (RD)|-5.1||||0.05|TWO_SIDED|95.0|-8.7|-1.5||For a significance level of 0.05, the statistical test is equivalent to obtaining the two-sided 95% confidence interval for the difference of r\_b-r\_a.|Cochran-Mantel-Haenszel|||For primary Safety endpoint, unfavorable outcomes for Arm1(control) vs Arm3(2PHZM/2PHM) will be considered first, if non-inferiority criteria are met, then Arm 1 vs Arm 2(2PHZE/2PH) will be compared. The proportion of participants with unfavorable outcome can be estimated as: if r\_a and r\_b are the proportions of unfavorable outcome for the two study arms (a=Arm1 and b = Arm2 or Arm3) and if δ is the non-inferiority margin (=6.6%), statistical hypothesis is H\_0:r\_b-r\_a≥δ vs.H\_1:r\_b-r\_a\<δ||-1.5|-8.7|0.05
71105946|NCT02410772|141718520|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|1.09|||||TWO_SIDED|95.0|-2.45|4.63||||||||4.63|-2.45|
71105947|NCT02410772|141718520|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|4.12|||||TWO_SIDED|95.0|0.45|7.79||||||||7.79|0.45|
71019171|NCT01289990|141546099|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.11|-0.69||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.69|-1.11|<0.0001
71019172|NCT01289990|141546099|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.1||0.0322|TWO_SIDED|95.0|-0.41|-0.02||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.02|-0.41|0.0322
71019173|NCT01289990|141546099|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.1||0.0038|TWO_SIDED|95.0|-0.48|-0.09||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.09|-0.48|0.0038
71019174|NCT01289990|141546099|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.83|-0.4||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.40|-0.83|<0.0001
71019175|NCT01289990|141546099|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.62|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.9|-0.33||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.33|-0.90|<0.0001
71019176|NCT01289990|141546099|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.0|-0.44||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.44|-1.00|<0.0001
71019177|NCT01289990|141546099|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.87|-0.47||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.47|-0.87|<0.0001
71019178|NCT01289990|141546099|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.83|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-1.04|-0.63||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.63|-1.04|<0.0001
71019179|NCT01289990|141546099|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.04|-0.57||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.57|-1.04|<0.0001
71052385|NCT03118570|141609392|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.513||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.513
71105948|NCT02410772|141718521|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|1.05|||||TWO_SIDED|95.0|-2.01|4.11||||||||4.11|-2.01|
71105949|NCT02410772|141718521|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066)|Risk Difference (RD)|3.66|||||TWO_SIDED|95.0|0.42|6.9||||||||6.90|0.42|
71019180|NCT01289990|141546099|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.04|-0.56||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.56|-1.04|<0.0001
71019181|NCT01289990|141546100|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.6|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|-6.8|-2.5||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-2.5|-6.8|<0.0001
71019182|NCT01289990|141546100|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.2|STANDARD_ERROR_OF_MEAN|1.1||0.0001|TWO_SIDED|95.0|-6.4|-2.1||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-2.1|-6.4|0.0001
71019183|NCT01289990|141546100|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.4|STANDARD_ERROR_OF_MEAN|1.1||0.2107|TWO_SIDED|95.0|-3.5|0.8||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.8|-3.5|0.2107
71019184|NCT01289990|141546100|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.3|STANDARD_ERROR_OF_MEAN|1.1||0.0033|TWO_SIDED|95.0|-5.4|-1.1||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.1|-5.4|0.0033
71019185|NCT01289990|141546100|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.8|STANDARD_ERROR_OF_MEAN|1.1||0.0105|TWO_SIDED|95.0|-5.0|-0.7||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.7|-5.0|0.0105
71019186|NCT01289990|141546100|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.4|STANDARD_ERROR_OF_MEAN|1.3||0.0543|TWO_SIDED|95.0|-4.9|0.0||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.0|-4.9|0.0543
71019187|NCT01289990|141546100|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.9|STANDARD_ERROR_OF_MEAN|1.2||0.0019|TWO_SIDED|95.0|-6.4|-1.5||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.5|-6.4|0.0019
71019188|NCT01289990|141546100|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.0|STANDARD_ERROR_OF_MEAN|1.0||0.0045|TWO_SIDED|95.0|-5.0|-0.9||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.9|-5.0|0.0045
71019189|NCT01289990|141546100|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.5|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|-6.6|-2.5||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-2.5|-6.6|<0.0001
71019190|NCT01289990|141546100|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.9|STANDARD_ERROR_OF_MEAN|1.0||0.0031|TWO_SIDED|95.0|-4.8|-1.0||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.0|-4.8|0.0031
71019191|NCT01289990|141546100|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.5|STANDARD_ERROR_OF_MEAN|1.0||0.0096|TWO_SIDED|95.0|-4.4|-0.6||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.6|-4.4|0.0096
71052386|NCT03118570|141609392|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.849||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.849
71052387|NCT03118570|141609392|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.037||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.037
71019192|NCT01289990|141546101|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.78|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.94|-0.63||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.63|-0.94|<0.0001
71019193|NCT01289990|141546101|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.89|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-1.04|-0.73||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.73|-1.04|<0.0001
71019194|NCT01289990|141546101|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.82|-0.51||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.51|-0.82|<0.0001
71019195|NCT01289990|141546101|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.08||0.131|TWO_SIDED|95.0|-0.28|0.04||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||0.04|-0.28|0.1310
71019196|NCT01289990|141546101|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.005|TWO_SIDED|95.0|-0.38|-0.07||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.07|-0.38|0.0050
71019197|NCT01289990|141546101|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.79|-0.4||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.40|-0.79|<0.0001
71019198|NCT01289990|141546101|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.88|-0.5||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.50|-0.88|<0.0001
71052388|NCT03118570|141609392|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.88||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.880
71105950|NCT02410772|141718523|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|3.0|||||TWO_SIDED|95.0|-0.6|6.6||||||||6.6|-0.6|
71052389|NCT03118570|141609392|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.153||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.153
71052390|NCT03118570|141609392|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.073||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.073
71019199|NCT01289990|141546101|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.75|-0.46||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.46|-0.75|<0.0001
71019200|NCT01289990|141546101|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.88|-0.58||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.58|-0.88|<0.0001
71019201|NCT01289990|141546101|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.87|-0.56|||ANCOVA|||||-0.56|-0.87|<0.0001
71019202|NCT01289990|141546101|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.85|-0.53||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.53|-0.85|<0.0001
71019203|NCT01289990|141546102|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.4|STANDARD_ERROR_OF_MEAN|1.1||0.0025|TWO_SIDED|95.0|-5.5|-1.2||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.2|-5.5|0.0025
71019204|NCT01289990|141546102|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.4|STANDARD_ERROR_OF_MEAN|1.1||0.0021|TWO_SIDED|95.0|-5.6|-1.2||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.2|-5.6|0.0021
71019205|NCT01289990|141546102|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.4|STANDARD_ERROR_OF_MEAN|1.1||0.7241|TWO_SIDED|95.0|-1.8|2.6||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||2.6|-1.8|0.7241
71019206|NCT01289990|141546102|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.7|STANDARD_ERROR_OF_MEAN|1.1||0.0008|TWO_SIDED|95.0|-5.9|-1.6||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.6|-5.9|0.0008
71019207|NCT01289990|141546102|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.8|STANDARD_ERROR_OF_MEAN|1.1||0.0007|TWO_SIDED|95.0|-6.0|-1.6||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.6|-6.0|0.0007
71019208|NCT01289990|141546102|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.0|STANDARD_ERROR_OF_MEAN|1.2||0.0987|TWO_SIDED|95.0|-4.5|0.4||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.4|-4.5|0.0987
71052391|NCT03118570|141609392|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.007||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.007
71052392|NCT03118570|141609392|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.791||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.791
71052393|NCT03118570|141609392|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.01||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.010
71019209|NCT01289990|141546102|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.7|STANDARD_ERROR_OF_MEAN|1.2||0.0028|TWO_SIDED|95.0|-6.1|-1.3||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.3|-6.1|0.0028
71019210|NCT01289990|141546102|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.4|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|-6.6|-2.3||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-2.3|-6.6|<0.0001
71019211|NCT01289990|141546102|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.7|STANDARD_ERROR_OF_MEAN|1.1||0.0008|TWO_SIDED|95.0|-5.9|-1.5||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.5|-5.9|0.0008
71019212|NCT01289990|141546102|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.2|STANDARD_ERROR_OF_MEAN|1.0||0.0213|TWO_SIDED|95.0|-4.1|-0.3||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.3|-4.1|0.0213
71019213|NCT01289990|141546102|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.1|STANDARD_ERROR_OF_MEAN|1.0||0.0288|TWO_SIDED|95.0|-4.1|-0.2||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.2|-4.1|0.0288
71052394|NCT03118570|141609392|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.553||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.553
71052395|NCT03118570|141609392|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.652||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.652
71105951|NCT02410772|141718523|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|2.29|||||TWO_SIDED|95.0|-1.12|5.7||||||||5.70|-1.12|
71105952|NCT02410772|141718524|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|5.9|||||TWO_SIDED|95.0|2.8|8.9||||||||8.9|2.8|
71105953|NCT02410772|141718524|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|3.4|||||TWO_SIDED|95.0|0.5|6.3||||||||6.3|0.5|
71105954|NCT02369536|141718525|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||ANOVA|||Intention-to-treat-analysis. Differences between basal values in active and control groups and between T1 vsT0 changes in the two groups assessed by ANOVA and Fisher's exact test.||||<0.05
71019214|NCT01289990|141546103|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.7||0.1058|TWO_SIDED|95.0|-2.4|0.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.2|-2.4|0.1058
71019215|NCT01289990|141546103|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.0109|TWO_SIDED|95.0|-3.1|-0.4||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.4|-3.1|0.0109
71019216|NCT01289990|141546103|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.7||0.8259|TWO_SIDED|95.0|-1.5|1.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||1.2|-1.5|0.8259
71019217|NCT01289990|141546103|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.7||0.166|TWO_SIDED|95.0|-2.3|0.4||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.4|-2.3|0.1660
71019218|NCT01289990|141546103|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.7||0.0212|TWO_SIDED|95.0|-2.9|-0.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.2|-2.9|0.0212
71019219|NCT01289990|141546103|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.7||0.0076|TWO_SIDED|95.0|-3.4|-0.5||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.5|-3.4|0.0076
71019220|NCT01289990|141546103|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.7||0.0003|TWO_SIDED|95.0|-4.1|-1.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.2|-4.1|0.0003
71019221|NCT01289990|141546103|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.7||0.017|TWO_SIDED|95.0|-3.2|-0.3||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.3|-3.2|0.0170
71019222|NCT01289990|141546103|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.0236|TWO_SIDED|95.0|-3.1|-0.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.2|-3.1|0.0236
71019223|NCT01289990|141546103|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.2523|TWO_SIDED|95.0|-2.0|0.5||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.5|-2.0|0.2523
71019224|NCT01289990|141546103|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.6||0.3494|TWO_SIDED|95.0|-1.9|0.7||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.7|-1.9|0.3494
71019225|NCT01289990|141546104|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.7||0.1568|TWO_SIDED|95.0|-2.3|0.4||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.4|-2.3|0.1568
71019226|NCT01289990|141546104|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.7||0.1323|TWO_SIDED|95.0|-2.4|0.3||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.3|-2.4|0.1323
71019227|NCT01289990|141546104|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.7||0.4327|TWO_SIDED|95.0|-0.8|1.9||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||1.9|-0.8|0.4327
71019228|NCT01289990|141546104|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.7||0.0289|TWO_SIDED|95.0|-2.8|-0.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.2|-2.8|0.0289
71019229|NCT01289990|141546104|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.7||0.0231|TWO_SIDED|95.0|-2.9|-0.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.2|-2.9|0.0231
71019230|NCT01289990|141546104|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.8||0.0513|TWO_SIDED|95.0|-3.0|0.0||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.0|-3.0|0.0513
71105955|NCT02369536|141718528|SUPERIORITY||||||<|0.05|||||||ANOVA|||Intention-to-treat-analysis. Differences between basal values in active and control groups and between T1 vsT0 changes in the two groups assessed by ANOVA and Fisher's exact test.||||<0.05
71105956|NCT00560417|141718558|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin was prespecified at 0.4%|Mean Difference (Final Values)|0.22|||||TWO_SIDED|95.0|0.06|0.38|||ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group.||||0.38|0.06|
71105957|NCT00560417|141718559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.003|TWO_SIDED|95.0|0.08|0.39||p-value is for 24 weeks.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||0.39|0.08|0.003
70851261|NCT00669409|141190532|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-27.6|14.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||14.9|-27.6|
70851262|NCT00669409|141190533|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-21.6|11.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.8|-21.6|
71019231|NCT01289990|141546104|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.8||0.0038|TWO_SIDED|95.0|-3.7|-0.7||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.7|-3.7|0.0038
71019232|NCT01289990|141546104|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.7||0.0084|TWO_SIDED|95.0|-3.4|-0.5||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.5|-3.4|0.0084
71019233|NCT01289990|141546104|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.7||0.0677|TWO_SIDED|95.0|-2.8|0.1||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.1|-2.8|0.0677
71019234|NCT01289990|141546104|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.7||0.0814|TWO_SIDED|95.0|-2.4|0.1||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.1|-2.4|0.0814
71019235|NCT01289990|141546104|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.7||0.1785|TWO_SIDED|95.0|-2.2|0.4||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.4|-2.2|0.1785
71019236|NCT01289990|141546105|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.22|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-2.75|-1.69||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.69|-2.75|<0.0001
71019237|NCT01289990|141546105|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.14|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-2.66|-1.61||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.61|-2.66|<0.0001
71019238|NCT01289990|141546105|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.62|STANDARD_ERROR_OF_MEAN|0.27||0.0223|TWO_SIDED|95.0|0.09|1.14||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||1.14|0.09|0.0223
71019239|NCT01289990|141546105|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.84|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-3.37|-2.31||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-2.31|-3.37|<0.0001
71019240|NCT01289990|141546105|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.75|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-3.28|-2.22|||ANCOVA|||||-2.22|-3.28|<0.0001
71019241|NCT01289990|141546105|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.09|STANDARD_ERROR_OF_MEAN|0.34|<|0.0001|TWO_SIDED|95.0|-2.76|-1.41||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.41|-2.76|<0.0001
71019242|NCT01289990|141546105|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.99|STANDARD_ERROR_OF_MEAN|0.34|<|0.0001|TWO_SIDED|95.0|-2.66|-1.32||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.32|-2.66|<0.0001
71052396|NCT03118570|141609392|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||< 0.001
71052397|NCT03118570|141609392|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.482||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.482
71019243|NCT01289990|141546105|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.73|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.27|-1.19||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.19|-2.27|<0.0001
71019244|NCT01289990|141546105|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.85|-1.76||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.76|-2.85|<0.0001
71019245|NCT01289990|141546105|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.97|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.48|-1.47||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.47|-2.48|<0.0001
71019246|NCT01289990|141546105|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.01|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.52|-1.5||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.50|-2.52|<0.0001
71019247|NCT01289990|141546106|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.81|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.35|-1.26||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.26|-2.35|<0.0001
71019248|NCT01289990|141546106|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.02|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.56|-1.48||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.48|-2.56|<0.0001
71052398|NCT03118570|141609392|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.685||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.685
71105958|NCT00560417|141718559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.008|TWO_SIDED|95.0|0.06|0.38||p-value is for Endpoint (LOCF)|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||0.38|0.06|0.008
71019249|NCT01289990|141546106|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.54|STANDARD_ERROR_OF_MEAN|0.28||0.0546|TWO_SIDED|95.0|-0.01|1.08||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||1.08|-0.01|0.0546
71019250|NCT01289990|141546106|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.34|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.89|-1.8||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.80|-2.89|<0.0001
71019251|NCT01289990|141546106|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.56|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-3.1|-2.01||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-2.01|-3.10|<0.0001
71019252|NCT01289990|141546106|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.97|STANDARD_ERROR_OF_MEAN|0.37|<|0.0001|TWO_SIDED|95.0|-2.69|-1.24||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.24|-2.69|<0.0001
71019253|NCT01289990|141546106|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.71|STANDARD_ERROR_OF_MEAN|0.37|<|0.0001|TWO_SIDED|95.0|-2.43|-0.99||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.99|-2.43|<0.0001
71019254|NCT01289990|141546106|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.93|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.52|-1.34||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.34|-2.52|<0.0001
71019255|NCT01289990|141546106|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.19|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.79|-1.6||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.60|-2.79|<0.0001
71019256|NCT01289990|141546106|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.81|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-2.34|-1.27||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.27|-2.34|<0.0001
71019257|NCT01289990|141546106|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.64|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-2.18|-1.11||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.11|-2.18|<0.0001
71019258|NCT01289990|141546107|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.5||0.0001|TWO_SIDED|95.0|-3.1|-1.0||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.0|-3.1|0.0001
71019259|NCT01289990|141546107|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.5||0.0015|TWO_SIDED|95.0|-2.8|-0.7||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.7|-2.8|0.0015
71019260|NCT01289990|141546107|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.5||0.5052|TWO_SIDED|95.0|-0.7|1.4||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||1.4|-0.7|0.5052
71052399|NCT03118570|141609392|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.002||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.002
71052400|NCT03118570|141609392|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.672||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.672
71019261|NCT01289990|141546107|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|-3.5|-1.4||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.4|-3.5|<0.0001
71019262|NCT01289990|141546107|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.5||0.0001|TWO_SIDED|95.0|-3.1|-1.0||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.0|-3.1|0.0001
71019263|NCT01289990|141546107|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.5||0.0064|TWO_SIDED|95.0|-2.6|-0.4||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.4|-2.6|0.0064
71019264|NCT01289990|141546107|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.5||0.0642|TWO_SIDED|95.0|-2.1|0.1||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.1|-2.1|0.0642
71019265|NCT01289990|141546107|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.0053|TWO_SIDED|95.0|-1.8|-0.3||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.3|-1.8|0.0053
71019266|NCT01289990|141546107|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-2.3|-0.9|||ANCOVA|||||-0.9|-2.3|<0.0001
71019267|NCT01289990|141546107|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.4||0.001|TWO_SIDED|95.0|-2.1|-0.6||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.6|-2.1|0.0010
71052401|NCT03118570|141609392|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.377||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.377
71019268|NCT01289990|141546107|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.4||0.0015|TWO_SIDED|95.0|-2.1|-0.5||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.5|-2.1|0.0015
71019269|NCT01289990|141546108|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.5||0.0028|TWO_SIDED|95.0|-2.7|-0.6||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.6|-2.7|0.0028
71019270|NCT01289990|141546108|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.5||0.0019|TWO_SIDED|95.0|-2.8|-0.6||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.6|-2.8|0.0019
71019271|NCT01289990|141546108|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.6||0.5044|TWO_SIDED|95.0|-0.7|1.5||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||1.5|-0.7|0.5044
71019272|NCT01289990|141546108|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6||0.0003|TWO_SIDED|95.0|-3.1|-0.9||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.9|-3.1|0.0003
71019273|NCT01289990|141546108|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.6||0.0002|TWO_SIDED|95.0|-3.2|-1.0||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.0|-3.2|0.0002
71019274|NCT01289990|141546108|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.6||0.0109|TWO_SIDED|95.0|-2.5|-0.3||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.3|-2.5|0.0109
71019275|NCT01289990|141546108|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.6||0.1238|TWO_SIDED|95.0|-1.9|0.2||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.2|-1.9|0.1238
71019276|NCT01289990|141546108|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-2.4|-0.8||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.8|-2.4|<0.0001
71019277|NCT01289990|141546108|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.4||0.0076|TWO_SIDED|95.0|-1.9|-0.3||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.3|-1.9|0.0076
71019278|NCT01289990|141546108|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.4||0.0049|TWO_SIDED|95.0|-2.1|-0.4||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.4|-2.1|0.0049
71019279|NCT01289990|141546108|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.0178|TWO_SIDED|95.0|-1.9|-0.2||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.2|-1.9|0.0178
71052402|NCT03118570|141609392|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.015||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.015
71052403|NCT03118570|141609392|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.086||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.086
71019280|NCT01289990|141546109|SUPERIORITY_OR_OTHER||Adjusted mean difference|-32.3|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-37.8|-26.7||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-26.7|-37.8|<0.0001
71019281|NCT01289990|141546109|SUPERIORITY_OR_OTHER||Adjusted mean difference|-37.2|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-42.8|-31.7||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-31.7|-42.8|<0.0001
71019282|NCT01289990|141546109|SUPERIORITY_OR_OTHER||Adjusted mean difference|-17.3|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-22.9|-11.7||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-11.7|-22.9|<0.0001
71019283|NCT01289990|141546109|SUPERIORITY_OR_OTHER||Adjusted mean difference|-15.0|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-20.6|-9.4||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-9.4|-20.6|<0.0001
71019284|NCT01289990|141546109|SUPERIORITY_OR_OTHER||Adjusted mean difference|-19.9|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-25.5|-14.4||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-14.4|-25.5|<0.0001
71019285|NCT01289990|141546109|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.1|STANDARD_ERROR_OF_MEAN|4.0|<|0.0001|TWO_SIDED|95.0|-35.0|-19.2||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-19.2|-35.0|<0.0001
71052404|NCT03118570|141609392|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.712||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.712
71019286|NCT01289990|141546109|SUPERIORITY_OR_OTHER||Adjusted mean difference|-31.0|STANDARD_ERROR_OF_MEAN|4.0|<|0.0001|TWO_SIDED|95.0|-38.9|-23.2||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-23.2|-38.9|<0.0001
71019287|NCT01289990|141546109|SUPERIORITY_OR_OTHER||Adjusted mean difference|-24.3|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|95.0|-29.7|-18.9||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-18.9|-29.7|<0.0001
71019288|NCT01289990|141546109|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.3|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-32.7|-21.9||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-21.9|-32.7|<0.0001
71019289|NCT01289990|141546109|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.8|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-33.6|-22.0||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-22.0|-33.6|<0.0001
71019290|NCT01289990|141546109|SUPERIORITY_OR_OTHER||Adjusted mean difference|-28.7|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|-34.5|-22.8||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-22.8|-34.5|<0.0001
71019291|NCT01289990|141546110|SUPERIORITY_OR_OTHER||Adjusted mean difference|-31.7|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-37.4|-25.9||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-25.9|-37.4|<0.0001
71019292|NCT01289990|141546110|SUPERIORITY_OR_OTHER||Adjusted mean difference|-34.9|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-40.7|-29.1||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-29.1|-40.7|<0.0001
71019293|NCT01289990|141546110|SUPERIORITY_OR_OTHER||Adjusted mean difference|-16.3|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|-22.1|-10.5||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-10.5|-22.1|<0.0001
71019294|NCT01289990|141546110|SUPERIORITY_OR_OTHER||Adjusted mean difference|-15.4|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|-21.2|-9.6||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-9.6|-21.2|<0.0001
71019295|NCT01289990|141546110|SUPERIORITY_OR_OTHER||Adjusted mean difference|-18.7|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|-24.5|-12.8||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-12.8|-24.5|<0.0001
71052405|NCT03118570|141609394|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.045||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lean, Month 6||||0.045
71105959|NCT00560417|141718560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.003|TWO_SIDED|95.0|0.08|0.39||p-value is for 24 Weeks change.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||0.39|0.08|0.003
71019296|NCT01289990|141546110|SUPERIORITY_OR_OTHER||Adjusted mean difference|-23.3|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001|TWO_SIDED|95.0|-31.4|-15.3||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-15.3|-31.4|<0.0001
71019297|NCT01289990|141546110|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.4|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001|TWO_SIDED|95.0|-35.4|-19.4||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-19.4|-35.4|<0.0001
71019298|NCT01289990|141546110|SUPERIORITY_OR_OTHER||Adjusted mean difference|-25.1|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-30.5|-19.6||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-19.6|-30.5|<0.0001
71019299|NCT01289990|141546110|SUPERIORITY_OR_OTHER||Adjusted mean difference|-31.4|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-36.9|-25.9||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-25.9|-36.9|<0.0001
71019300|NCT01289990|141546110|SUPERIORITY_OR_OTHER||Adjusted mean difference|-31.0|STANDARD_ERROR_OF_MEAN|3.1|<|0.0001|TWO_SIDED|95.0|-37.0|-24.9||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-24.9|-37.0|<0.0001
71019301|NCT01289990|141546110|SUPERIORITY_OR_OTHER||Adjusted mean difference|-31.8|STANDARD_ERROR_OF_MEAN|3.1|<|0.0001|TWO_SIDED|95.0|-37.9|-25.7||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-25.7|-37.9|<0.0001
71052406|NCT03118570|141609394|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.101||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lean, Month 6||||0.101
71052407|NCT03118570|141609394|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.482||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lean, Month 6||||0.482
71105960|NCT00560417|141718560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.008|TWO_SIDED|95.0|0.06|0.38||p-value is for Endpoint (LOCF) Change.|ANCOVA|||||0.38|0.06|0.008
71105961|NCT00560417|141718561|SUPERIORITY_OR_OTHER|||||||0.561||95.0||||p-value is for Week 12: HbA1c \<7.0%|Fisher Exact|||||||0.561
71105962|NCT00560417|141718561|SUPERIORITY_OR_OTHER|||||||0.511||95.0||||p-value is for Week 12: HbA1c \<=6.5%|Fisher Exact|||||||0.511
71105963|NCT00560417|141718561|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||p-value is for Week 18: HbA1c \<7.0%|Fisher Exact|||||||0.012
71105964|NCT00560417|141718561|SUPERIORITY_OR_OTHER|||||||0.269||95.0||||p-value is for Week 18: HbA1c \<=6.5%|Fisher Exact|||||||0.269
71019302|NCT01488071|141546126|NON_INFERIORITY_OR_EQUIVALENCE|"Mixed model for repeated measurements (MMRM), using all available data, with a freely varying mean and covariance structures and with treatment, week, and site group as fixed factors and the baseline score as a covariate. The model also included interaction between week and baseline score, as well as interaction between week and treatment.~Non-inferiority, upper limit of Confidence Interval should not exceed 2."|Mean Difference (Final Values)|-2.16|STANDARD_ERROR_OF_MEAN|0.69||0.0018|TWO_SIDED|95.0|-3.51|-0.81||Under established non-inferiority the p-value is not adjusted.|Mixed Models Analysis|MMRM||||-0.81|-3.51|0.0018
70851263|NCT00669409|141190533|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.5|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-36.1|-2.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.9|-36.1|
71019303|NCT01488071|141546127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.03|STANDARD_ERROR_OF_MEAN|0.72||0.0054|TWO_SIDED|95.0|-3.45|-0.6||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.60|-3.45|0.0054
71019304|NCT01488071|141546128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.89|STANDARD_ERROR_OF_MEAN|0.56||0.0008|TWO_SIDED|95.0|-2.98|-0.8||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.80|-2.98|0.0008
71019305|NCT01488071|141546129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|0.57||0.0007|TWO_SIDED|95.0|-3.04|-0.81||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.81|-3.04|0.0007
71019306|NCT01488071|141546130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0023|TWO_SIDED|95.0|-0.48|-0.11||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.11|-0.48|0.0023
71019307|NCT01488071|141546131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.1||0.0075|TWO_SIDED|95.0|-0.47|-0.07||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.07|-0.47|0.0075
71019308|NCT01488071|141546132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.09||0.0048|TWO_SIDED|95.0|-0.42|-0.08||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.08|-0.42|0.0048
71019309|NCT01488071|141546133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.09||0.0055|TWO_SIDED|95.0|-0.42|-0.07||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.07|-0.42|0.0055
71019310|NCT01488071|141546134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.0012|TWO_SIDED|95.0|1.26|2.6||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic|||||2.60|1.26|0.0012
71019311|NCT01488071|141546135|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.0014|TWO_SIDED|95.0|1.26|2.65||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic|||||2.65|1.26|0.0014
71019312|NCT01488071|141546136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72||||0.0054|TWO_SIDED|95.0|1.17|2.52||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic|||||2.52|1.17|0.0054
71019313|NCT01488071|141546137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01||||0.0002|TWO_SIDED|95.0|1.39|2.9||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic|||||2.90|1.39|0.0002
71019314|NCT01488071|141546138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.22|STANDARD_ERROR_OF_MEAN|0.72||0.0021|TWO_SIDED|95.0|-3.63|-0.81||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.81|-3.63|0.0021
71019315|NCT01488071|141546139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75|STANDARD_ERROR_OF_MEAN|0.75||0.0209|TWO_SIDED|95.0|-3.23|-0.27||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.27|-3.23|0.0209
71019316|NCT02720094|141546151|SUPERIORITY||A bias-adjusted hazard ratio|0.34||||0.0005|TWO_SIDED|95.0|0.18|0.62|||Regression, Cox||The bias-adjusted hazard ratio, CI, and p-value account for the group-sequential trial design and the early stopping time.|||0.62|0.18|0.0005
71019317|NCT02720094|141546151|SUPERIORITY||Hazard Ratio (HR)|0.328||||0.0005|TWO_SIDED|95.0|0.18|0.61|||Regression, Cox||The unadjusted hazard ratio is based on a Cox proportional hazards model stratified by region.|||0.61|0.18|0.0005
71019318|NCT02720094|141546153|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.001|TWO_SIDED|95.0|0.1|0.45||The P-Values are two-sided.|Regression, Cox|||The analysis population Injection Step 2 Efficacy consists of the subset of the mITT population who received at least one injection and had at least one HIV test result after the week 5 injection visit.||0.45|0.10|<0.001
71019319|NCT02913261|141546190|SUPERIORITY||Odds Ratio (OR)|2.64|||<|0.0001|TWO_SIDED|95.0|1.65|4.22|||Stratified Cochran-Mantel-Haenszel|||||4.22|1.65|<.0001
71019320|NCT02913261|141546191|SUPERIORITY||Odds Ratio (OR)|2.38||||0.0005|TWO_SIDED|95.0|1.43|3.94|||Stratified Cochran-Mantel-Haenszel|||||3.94|1.43|0.0005
71019321|NCT02913261|141546192|SUPERIORITY||Odds Ratio (OR)|1.98||||0.0029|TWO_SIDED|95.0|1.24|3.17|||Stratified Cochran-Mantel-Haenszel|||||3.17|1.24|0.0029
71019322|NCT02913261|141546204|SUPERIORITY||Odds Ratio (OR)|3.07|||<|0.0001|TWO_SIDED|95.0|1.8|5.25|||Stratified Cochran-Mantel-Haenszel|||||5.25|1.80|<.0001
71019323|NCT02340078|141546217|SUPERIORITY||Subjects % with difference in VAS ≥ 10mm|0.9516|||||TWO_SIDED|95.0|0.87|0.99||||||||0.99|0.87|
71019324|NCT02524665|141546230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.67|STANDARD_DEVIATION|61.97||0.0769||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used|Wilcoxon signed-rank test||Comparison of inflammatory lesion counts between MAXCLARITY II and Murad at Week 8.|||||0.0769
71105965|NCT00560417|141718561|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||p-value is for Week 24: HbA1c \<7.0%|Fisher Exact|||||||0.161
71105966|NCT00560417|141718561|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||p-value is for Week 24: HbA1c \<=6.5%|Fisher Exact|||||||0.071
71105967|NCT00560417|141718561|SUPERIORITY_OR_OTHER|||||||0.177||95.0||||p-value is for Endpoint (LOCF): HbA1c \<7.0%|Fisher Exact|||||||0.177
71105968|NCT00560417|141718561|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||p-value is for Endpoint (LOCF): HbA1c \<=6.5%|Fisher Exact|||||||0.060
71019325|NCT02524665|141546230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.77|STANDARD_DEVIATION|33.73||0.6698||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.|Wilcoxon signed-rank test||Comparison of non-inflammatory lesion counts between MAXCLARITY II and Murad at Week 8.|||||0.6698
71019326|NCT02524665|141546230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.66|STANDARD_DEVIATION|17.59||0.6854||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of total lesion counts between MAXCLARITY II and Murad at Week 8.|||||0.6854
71019327|NCT02524665|141546231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|STANDARD_DEVIATION|74.55||0.5031||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.|Wilcoxon signed-rank test||Comparison of percent change inflammatory lesion counts between MAXCLARITY II and Murad at Week 1.|||||0.5031
71019328|NCT02524665|141546231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.11|STANDARD_DEVIATION|99.76||0.2464||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of percent change inflammatory lesion counts between MAXCLARITY II and Murad at Week 2.|||||0.2464
71019329|NCT02524665|141546231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.03|STANDARD_DEVIATION|65.22||0.8894||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.|Wilcoxon signed-rank test||Comparison of percent change inflammatory lesion counts between MAXCLARITY II and Murad at Week 4.|||||0.8894
71019330|NCT02524665|141546231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.98|STANDARD_ERROR_OF_MEAN|46.04||0.6722||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.|Wilcoxon signed-rank test||Comparison of percent change non-inflammatory lesion counts between MAXCLARITY II and Murad at Week 1.|||||0.6722
71019331|NCT02524665|141546231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.99|STANDARD_DEVIATION|39.59||0.3352||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of percent change non-inflammatory lesion counts between MAXCLARITY II and Murad at Week 2.|||||0.3352
71019332|NCT02524665|141546231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.41|STANDARD_DEVIATION|35.46||0.9323||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.|Wilcoxon signed-rank test||Comparison of percent change non-inflammatory lesion counts between MAXCLARITY II and Murad at Week 4.|||||0.9323
71019333|NCT02524665|141546231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.72|STANDARD_DEVIATION|26.05||0.3513||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of percent change total lesion counts between MAXCLARITY II and Murad at Week 1.|||||0.3513
71019334|NCT02524665|141546231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22|STANDARD_DEVIATION|22.97||0.8199||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of percent change total lesion counts between MAXCLARITY II and Murad at Week 2.|||||0.8199
71019335|NCT02524665|141546231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_DEVIATION|17.83||0.9616||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of percent change total lesion counts between MAXCLARITY II and Murad at Week 4.|||||0.9616
71019336|NCT02524665|141546232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|0.23||1||95.0|||||Wilcoxon signed-rank test||Comparison of ISGA score between MAXCLARITY II and Murad at Week 1|||||1.0000
71019337|NCT02524665|141546232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_DEVIATION|0.66||0.75||95.0|||||Wilcoxon signed-rank test||Comparison of ISGA score between MAXCLARITY II and Murad at Week 2.|||||0.7500
71019338|NCT02524665|141546232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_DEVIATION|0.74||0.7539||95.0|||||Wilcoxon signed-rank test||Comparison of ISGA score between MAXCLARITY II and Murad at Week 4.|||||0.7539
71019339|NCT02524665|141546232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.87||0.3071||95.0|||||Wilcoxon signed-rank test||Comparison of ISGA score between MAXCLARITY II and Murad at Week 8|||||0.3071
71019340|NCT02524665|141546233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_DEVIATION|0.5||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Erythema score between MAXCLARITY II and Murad at Week 1.|||||0.5000
71019341|NCT02524665|141546233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.52||1||95.0|||||Wilcoxon signed-rank test||Comparison of Erythema score between MAXCLARITY II and Murad at Week 2.|||||1.0000
71019342|NCT02524665|141546233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.23||1||95.0|||||Wilcoxon signed-rank test||Comparison of Erythema score between MAXCLARITY II and Murad at Week 4.|||||1.0000
71019343|NCT02524665|141546233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Erythema score between MAXCLARITY II and Murad at Week 8.|||||0
71019344|NCT02524665|141546233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_DEVIATION|0.74||1||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 1.|||||1.0000
71105969|NCT00560417|141718562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.28||||0.179|TWO_SIDED|95.0|-1.97|10.53||p-value is for Endpoint Morning Pre-Meal.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||10.53|-1.97|0.179
71019345|NCT02524665|141546233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 2.|||||0
71019346|NCT02524665|141546233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 4.|||||0
71019347|NCT02524665|141546233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.23||1||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 8.|||||1.0000
71019348|NCT02524665|141546233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_DEVIATION|0.69||1||95.0|||||Wilcoxon signed-rank test||Comparison of Peeling score between MAXCLARITY II and Murad at Week 1.|||||1.0000
71019349|NCT02524665|141546233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Peeling score between MAXCLARITY II and Murad at Week 2.|||||0
71019350|NCT02524665|141546233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Peeling score between MAXCLARITY II and Murad at Week 4.|||||0
71019351|NCT02524665|141546233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.23||1||95.0|||||Wilcoxon signed-rank test||Comparison of Peeling score between MAXCLARITY II and Murad at Week 8.|||||1.0000
71019352|NCT02524665|141546234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_DEVIATION|0.63||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Redness score between MAXCLARITY II and Murad at Week 1.|||||0.5000
71019353|NCT02524665|141546234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_DEVIATION|0.5||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Redness score between MAXCLARITY II and Murad at Week 2.|||||0.5000
71019354|NCT02524665|141546234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_DEVIATION|0.92||1||95.0|||||Wilcoxon signed-rank test||Comparison of Redness score between MAXCLARITY II and Murad at Week 4.|||||1.0000
71019355|NCT02524665|141546234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_DEVIATION|0.69||1||95.0|||||Wilcoxon signed-rank test||Comparison of Redness score between MAXCLARITY II and Murad at Week 8.|||||1.0000
71019356|NCT02524665|141546234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_DEVIATION|0.88||0.8125||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 1.|||||0.8125
70851264|NCT00669409|141190533|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-21.8|11.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.4|-21.8|
71019357|NCT02524665|141546234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_DEVIATION|0.94||0.5742||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 2.|||||0.5742
71019358|NCT02524665|141546234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.93||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 4.|||||0.5000
71019359|NCT02524665|141546234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_DEVIATION|0.82||0.25||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 8.|||||0.2500
71019360|NCT02524665|141546234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.62||1||95.0|||||Wilcoxon signed-rank test||Comparison of Burning score between MAXCLARITY II and Murad at Week 1.|||||1.0000
71019361|NCT02524665|141546234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_DEVIATION|0.74||0.75||95.0|||||Wilcoxon signed-rank test||Comparison of Burning score between MAXCLARITY II and Murad at Week 2.|||||0.7500
71019362|NCT02524665|141546234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_DEVIATION|0.98||0.75||95.0|||||Wilcoxon signed-rank test||Comparison of Burning score between MAXCLARITY II and Murad at Week 4.|||||0.7500
71019363|NCT02524665|141546234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.73||0.25||95.0|||||Wilcoxon signed-rank test||Comparison of Burning score between MAXCLARITY II and Murad at Week 8.|||||0.2500
71019364|NCT02524665|141546234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_DEVIATION|0.54||0.25||95.0|||||Wilcoxon signed-rank test||Comparison of Itching score between MAXCLARITY II and Murad at Week 1.|||||0.2500
71019365|NCT02524665|141546234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_DEVIATION|0.74||0.75||95.0|||||Wilcoxon signed-rank test||Comparison of Itching score between MAXCLARITY II and Murad at Week 2.|||||0.7500
71105970|NCT00560417|141718562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.96|||<|0.001|TWO_SIDED|95.0|5.72|22.19||p-value is for Endpoint Morning Postprandial.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||22.19|5.72|<0.001
71052408|NCT03118570|141609394|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.011||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lean, Month 12||||0.011
71052409|NCT03118570|141609394|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.508||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lean, Month 12||||0.508
71052410|NCT03118570|141609394|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.563||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lean, Month 12||||0.563
71052411|NCT03118570|141609394|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.917||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Fat, Month 6||||0.917
71052412|NCT03118570|141609394|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.789||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Fat, Month 6||||0.789
70932134|NCT02307682|141364349|OTHER||Difference in proportions|-2.2|||||TWO_SIDED|95.0|-8.4|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.2|-8.4|
70932135|NCT02307682|141364349|OTHER||Difference in proportions|-3.5|||||TWO_SIDED|95.0|-9.5|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||2.3|-9.5|
70932136|NCT02307682|141364349|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.6|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||3.6|-8.6|
70932137|NCT02307682|141364349|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.8|3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||3.2|-8.8|
70932138|NCT02307682|141364349|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-6.8|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||6.1|-6.8|
70932139|NCT02307682|141364349|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-5.9|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.1|-5.9|
70932140|NCT02307682|141364349|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-6.6|6.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.0|-6.6|
70932141|NCT02307682|141364349|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-5.7|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||6.4|-5.7|
70932142|NCT02307682|141364349|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-9.0|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.1|-9.0|
70932143|NCT02307682|141364349|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-7.2|5.5||Hypothesis testing not pre-specified.|Regression, Logistic|||Week 64||5.5|-7.2|
70932144|NCT02307682|141364349|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-6.6|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.7|-6.6|
70932145|NCT02307682|141364349|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-4.3|8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||8.3|-4.3|
71052413|NCT03118570|141609394|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.262||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Fat, Month 6||||0.262
71052414|NCT03118570|141609394|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.426||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Fat, Month 12||||0.426
71105971|NCT00560417|141718562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8||||0.325|TWO_SIDED|95.0|-3.79|11.39||p-value is for Endpoint Midday Pre-Meal.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||11.39|-3.79|0.325
71105972|NCT00560417|141718562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.73||||0.051|TWO_SIDED|95.0|-0.04|17.5||p-value is for Endpoint Midday Postprandial.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||17.50|-0.04|0.051
71105973|NCT00560417|141718562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.92||||0.003|TWO_SIDED|95.0|3.66|18.19||p-value is for Endpoint Evening Pre-Meal.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||18.19|3.66|0.003
71105974|NCT00560417|141718562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.19||||0.002|TWO_SIDED|95.0|5.44|22.94||p-value is for Endpoint Evening Postprandial.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||22.94|5.44|0.002
71105975|NCT00560417|141718562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.03||||0.415|TWO_SIDED|95.0|-10.35|4.28||p-value is for Endpoint 0300 Hours.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||4.28|-10.35|0.415
71105976|NCT00560417|141718562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.39||||0.015|TWO_SIDED|95.0|1.46|13.32||p-value is for Endpoint Daily Mean 7-Point Blood Glucose.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||13.32|1.46|0.015
71105977|NCT00560417|141718562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.12||||0.021|TWO_SIDED|95.0|1.1|13.14||p-value is for Endpoint Daily Mean Pre-Meal.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||13.14|1.10|0.021
71105978|NCT00560417|141718562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.97|||<|0.001|TWO_SIDED|95.0|5.01|18.93||p-value is for Endpoint Daily Mean Postprandial.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||18.93|5.01|<0.001
71105979|NCT00560417|141718563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.27||||0.131|TWO_SIDED|95.0|-0.68|5.22||p-value is for Baseline.|ANOVA|Variable = Treatment + Baseline HbA1c Group + Baseline SU Group||||5.22|-0.68|0.131
71105980|NCT00560417|141718563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.99|||<|0.001|TWO_SIDED|95.0|2.82|9.16||p-value is for Endpoint.|ANOVA|Variable = Treatment + Baseline HbA1c Group + Baseline SU Group||||9.16|2.82|<0.001
71105981|NCT00560417|141718564|SUPERIORITY_OR_OTHER|||||||0.826||95.0||||p-value is for all reported hypoglycemic events at endpoint.|Fisher Exact|||||||0.826
71105982|NCT00560417|141718564|SUPERIORITY_OR_OTHER|||||||0.394||95.0||||p-value is for all reported hypoglycemic events overall.|Fisher Exact|||||||0.394
71105983|NCT00560417|141718564|SUPERIORITY_OR_OTHER|||||||0.07||95.0||||p-value is for non-nocturnal hypoglycemic events at endpoint.|Fisher Exact|||||||0.070
71105984|NCT00560417|141718564|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||p-value is for non-nocturnal hypoglycemic events overall.|Fisher Exact|||||||0.133
71105985|NCT00560417|141718564|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||p-value is for nocturnal hypoglycemic events at endpoint.|Fisher Exact|||||||0.013
71105986|NCT00560417|141718564|SUPERIORITY_OR_OTHER|||||||0.061||95.0||||p-value is for nocturnal hypoglycemic events overall.|Fisher Exact|||||||0.061
71105987|NCT00560417|141718564|SUPERIORITY_OR_OTHER|||||||0.248||95.0||||p-value is for severe hypoglycemic events overall.|Fisher Exact|||||||0.248
71105988|NCT00560417|141718565|SUPERIORITY_OR_OTHER|||||||0.628||95.0||||p-value is for All reported episodes rate - Endpoint.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable||||||0.628
71019366|NCT02524665|141546234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_DEVIATION|1.01||0.25||95.0|||||Wilcoxon signed-rank test||Comparison of Itching score between MAXCLARITY II and Murad at Week 4.|||||0.2500
71105989|NCT00560417|141718565|SUPERIORITY_OR_OTHER|||||||0.57||95.0||||p-value is for All reported episodes rate - Overall.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable||||||0.570
71105990|NCT00560417|141718565|SUPERIORITY_OR_OTHER|||||||0.116||95.0||||p-value is for Non-Nocturnal reported episodes rate - Endpoint.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable||||||0.116
71105991|NCT00560417|141718565|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||p-value is for Non-Nocturnal reported episodes rate - Overall.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable||||||0.044
71105992|NCT00560417|141718565|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||p-value is for Nocturnal reported episodes rate - Endpoint.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable||||||0.006
71105993|NCT00560417|141718565|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||p-value is for Nocturnal reported episodes rate - Overall.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable||||||0.004
71105994|NCT00560417|141718566|SUPERIORITY_OR_OTHER|||||||0.343||95.0||||p-value is for endpoint.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group (Type III sums of squares)||||||0.343
71105995|NCT00560417|141718567|SUPERIORITY_OR_OTHER|||||||0.417||95.0||||p-value is for the change in body weight at endpoint in the ILPS treatment group.|t-test, 2 sided|||||||0.417
71105996|NCT00560417|141718567|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||p-value is for the change in body weight at endpoint in the glargine treatment group.|t-test, 2 sided|||||||0.041
71019367|NCT02524665|141546234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_DEVIATION|0.82||0.25||95.0|||||Wilcoxon signed-rank test||Comparison of Itching score between MAXCLARITY II and Murad at Week 8.|||||0.2500
71019368|NCT02524665|141546234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_DEVIATION|0.5||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Scaling score between MAXCLARITY II and Murad at Week 1.|||||0.5000
71019369|NCT02524665|141546234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Scaling score between MAXCLARITY II and Murad at Week 2.|||||0
71019370|NCT02524665|141546234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.93||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Scaling score between MAXCLARITY II and Murad at Week 4.|||||0.5000
71019371|NCT02524665|141546234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_DEVIATION|0.81||1||95.0|||||Wilcoxon signed-rank test||Comparison of Scaling score between MAXCLARITY II and Murad at Week 8.|||||1.0000
71019372|NCT02524665|141546235|SUPERIORITY_OR_OTHER|||||||1||95.0||||Comparison of one or more grade improvement between MAXCLARITY II and Murad at Week 1.|McNemar|||||||1.0000
71019373|NCT02524665|141546235|SUPERIORITY_OR_OTHER|||||||0||95.0||||The value is mentioned as '0', as no P-value generated. Comparison of two or more grade improvement between MAXCLARITY II and Murad at Week 1.|McNemar|||||||0
71019374|NCT02524665|141546235|SUPERIORITY_OR_OTHER|||||||0.5637||95.0||||Comparison of one or more grade improvement between MAXCLARITY II and Murad at Week 2.|McNemar|||||||0.5637
71019375|NCT02524665|141546235|SUPERIORITY_OR_OTHER|||||||1||95.0||||Comparison of two or more grade improvement between MAXCLARITY II and Murad at Week 2.|McNemar|||||||1.0000
71019376|NCT02524665|141546235|SUPERIORITY_OR_OTHER|||||||0.4795||95.0||||Comparison of one or more grade improvement between MAXCLARITY II and Murad at Week 4.|McNemar|||||||0.4795
71052415|NCT03118570|141609394|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.871||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Fat, Month 12||||0.871
71052416|NCT03118570|141609394|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.113||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Fat, Month 12||||0.113
71105997|NCT00560417|141718567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.343|TWO_SIDED|95.0|-1.15|0.4||p-value is for change in body weight at endpoint between ILPS and glargine treatment groups.|ANOVA|||||0.40|-1.15|0.343
71019377|NCT02524665|141546235|SUPERIORITY_OR_OTHER|||||||1||95.0||||Comparison of two or more grade improvement between MAXCLARITY II and Murad at Week 4.|McNemar|||||||1.0000
71019378|NCT02524665|141546235|SUPERIORITY_OR_OTHER|||||||0.3173||95.0||||Comparison of one or more grade improvement between MAXCLARITY II and Murad at Week 8.|McNemar|||||||0.3173
71019379|NCT02524665|141546235|SUPERIORITY_OR_OTHER|||||||0.1573||95.0||||Comparison of two or more grade improvement between MAXCLARITY II and Murad at Week 8.|McNemar|||||||0.1573
71019380|NCT00883129|141546287|SUPERIORITY_OR_OTHER|||||||0.24||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in the FVC %-predicted. Covariates were %-predicted FVC, HRCT-defined extent of lung fibrosis in the lobe of maximum involvement, and terms for time-trend, treatment and treatment-time trend interactions.||||0.24
71019381|NCT00883129|141546287|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||The inferential joint model, as described for the primary analysis, was used to estimate the change from baseline to 24 months for the FVC %-predicted for each treatment arm independently.||||<0.05
71019382|NCT00883129|141546287|SUPERIORITY_OR_OTHER|||||||0.55||||||The threshold for statistical significance was a P-Value of \</=0.05.|Fisher Exact|||Based on the absolute difference between the value of FVC %-predicted at baseline and at 24 months for each subject who returned for a 24-month assessment, a frequency distributions was prepared, stratified by treatment arm, to assess the relative distribution of subjects who either had improvements or worsening in the FVC %-predicted.||||0.55
71019383|NCT00883129|141546288|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in the TLC %-predicted.||||>0.05
71019384|NCT00883129|141546289|SUPERIORITY_OR_OTHER||||||<|0.001||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in the DLCO %-predicted.||||<0.001
71019385|NCT00883129|141546289|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||The inferential joint model, as described for the primary analysis, was used to estimate the change from baseline to 24 months for the DLCO %-predicted for each treatment arm independently.||||>0.05
71052417|NCT03118570|141609395|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 1||||< 0.001
71052418|NCT03118570|141609395|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 1||||< 0.001
71105998|NCT00560417|141718568|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|Variable = Treatment + Baseline HbA1c Group+ Baseline SU Group||||||<0.001
71019386|NCT00883129|141546290|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in the Quantitative Lung Fibrosis Score for the whole lung (QLF-WL).||||>0.05
71019387|NCT00883129|141546291|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in dyspnea as measured by the Transitional Dyspnea Index Score.||||>0.05
71019388|NCT00883129|141546291|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||The inferential joint model, as described for the primary analysis, was used to estimate the change from baseline to 24 months for dyspnea using the Transitional Dyspnea Index Score for each treatment arm independently.||||<0.05
71019389|NCT00883129|141546293|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in modified Rodnan Skin Score (mRSS).||||>0.05
71019390|NCT00883129|141546293|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||The inferential joint model, as described for the primary analysis, was used to estimate the change from baseline to 24 months for the modified Rodnan Skin Score for each treatment arm independently.||||<0.05
71019391|NCT00883129|141546293|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Fisher Exact|||Based on the absolute difference between the value of the mRSS at baseline and at 24 months for each subject who returned for a 24-month assessment, a frequency distributions was prepared, stratified by treatment arm, to assess the relative distribution of subjects who either had improvements or worsening in the mRSS.||||>0.05
71019392|NCT00883129|141546294|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Fisher Exact|The threshold for statistical significance was met only for the frequency of leukopenia and thrombocytopenia, but not for total SAE or death.||Fisher's Exact Test was utilized to compare the number of participants with a protocol-defined adverse event of interest, SAE or death between the MMF and CYC treatment arms.||||<0.05
71019393|NCT00883129|141546295|SUPERIORITY_OR_OTHER|||||||0.019||||||The threshold for statistical significance was a P-Value of \</=0.05.|Log Rank|||A log-rank test was utilized to assess differences between the MMF and CYC treatment arms with respect to the time to withdrawal from study drug or meeting protocol-defined criteria for treatment failure.||||0.019
71019394|NCT03273257|141546296|SUPERIORITY|||||||0.139|||||||2-sample Wilcoxon rank sum test|||The null hypothesis is that there is no difference between the treatment groups in percent change from baseline in PVR immediately before PEA.||||0.139
71052419|NCT03118570|141609395|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.984||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 1||||0.984
71052420|NCT03118570|141609395|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 3||||< 0.001
71105999|NCT02164864|141718574|NON_INFERIORITY|All non-inferiority tests were based on a margin of 1.38.|Hazard Ratio (HR)|0.52|||<|0.0001|TWO_SIDED|95.0|0.42|0.63||P values for noninferiority were calculated at a one-sided alpha level of 0.025|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|A pre-defined hierarchical testing approach was used. This was the first step in hierarchy. The upper bound of the Wald confidence interval (CI) of the HR of Dabigatran Etexilate 110mg vs Warfarin (one-sided 97.5%) was compared with this noninferiority margin for the testing of non-inferiority.||0.63|0.42|<0.0001
71019395|NCT04355767|141546322|SUPERIORITY|||||||||||||||||Analysis is of patients with a disease-progression event. The trial required a sample size of 900 patients to detect an absolute between-group difference of 10 percentage points (the minimum difference that we considered to be clinically important) with a power of 85%.|A Bayesian framework was used to calculate a risk difference of 1.9 percentage points (placebo group minus convalescent-plasma group) with a 95% credible interval of -6.0 to 9.8. The posterior probability of superiority was calculated to be 0.68. Efficacy was defined as a posterior probability of 0.975 or more that the proportion of patients with outcome events was higher in the placebo group.|||
71019396|NCT04355767|141546322|SUPERIORITY||Risk Difference (RD)|2.2|||||TWO_SIDED|95.0|-5.9|10.4|||||Risk difference after adjustment for age, sex, symptom duration.|Analysis is of patients with a disease-progression event.||10.4|-5.9|
71019397|NCT04355767|141546323|SUPERIORITY|||||||||||||||||Analysis is of patients with a disease-progression event.|A Bayesian framework was used to calculate a risk difference of 3.0 percentage points (placebo group minus convalescent-plasma group) with a 95% credible interval of -4.9 to 10.8. The posterior probability of superiority was calculated to be 0.76. Efficacy was defined as a posterior probability of 0.975 or more that the proportion of patients with outcome events was higher in the placebo group.|||
71019398|NCT04355767|141546325|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.69|1.17||||||||1.17|0.69|
71052421|NCT03118570|141609395|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.05||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 3||||0.050
71019399|NCT04355767|141546326|OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.4|1.1||||||||1.1|-0.4|
71019400|NCT02200614|141546332|SUPERIORITY||Hazard Ratio (HR)|0.413|||<|1e-06|TWO_SIDED|95.0|0.341|0.5|||Log Rank||Hazard ratio and 95% Confidence Interval (CI) was based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.500|0.341|<0.000001
71019401|NCT02200614|141546333|SUPERIORITY||Hazard Ratio (HR)|0.706||||0.04521|TWO_SIDED|95.0|0.501|0.994|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.994|0.501|0.045210
71019402|NCT02200614|141546334|SUPERIORITY||Hazard Ratio (HR)|0.647||||8e-06|TWO_SIDED|95.0|0.533|0.785|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.785|0.533|0.000008
71019403|NCT02200614|141546335|SUPERIORITY||Hazard Ratio (HR)|0.433|||<|1e-06|TWO_SIDED|95.0|0.314|0.595|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.595|0.314|<0.000001
71019404|NCT02200614|141546336|SUPERIORITY||Hazard Ratio (HR)|0.428||||0.011262|TWO_SIDED|95.0|0.218|0.842|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.842|0.218|0.011262
71019405|NCT02200614|141546337|SUPERIORITY||Hazard Ratio (HR)|0.685||||0.003048|TWO_SIDED|95.0|0.533|0.881|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.881|0.533|0.003048
71052422|NCT03118570|141609395|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.857||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 3||||0.857
71052423|NCT03118570|141609395|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.001
71052424|NCT03118570|141609395|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.079||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.079
71052425|NCT03118570|141609395|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.912||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.912
71052426|NCT03118570|141609395|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.054||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 9||||0.054
71019406|NCT02200614|141546338|SUPERIORITY||Hazard Ratio (HR)|0.647||||8e-06|TWO_SIDED|95.0|0.533|0.785|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.785|0.533|0.000008
71019407|NCT02200614|141546339|SUPERIORITY||Hazard Ratio (HR)|0.579||||4.4e-05|TWO_SIDED|95.0|0.444|0.755|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.755|0.444|0.000044
71019408|NCT02200614|141546340|SUPERIORITY||Hazard Ratio (HR)|0.484||||0.005294|TWO_SIDED|95.0|0.287|0.815|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.815|0.287|0.005294
71019409|NCT00391092|141546360|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.0775|TWO_SIDED|95.0|0.65|1.02|||Log Rank (unstratified)|||||1.02|0.65|0.0775
71019410|NCT00391092|141546361|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9543|TWO_SIDED|95.0|0.74|1.38|||Log Rank|||||1.38|0.74|0.9543
71019411|NCT00391092|141546362|SUPERIORITY_OR_OTHER||Difference in Response rates|4.43||||0.3492|TWO_SIDED|95.0|-5.2|14.0|||Chi-squared||95% CI for the difference in response rates using Hauck-Anderson method.|||14.0|-5.2|0.3492
71019412|NCT00391092|141546363|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.56|0.98||||||||0.98|0.56|
71019413|NCT00391092|141546364|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.5392|TWO_SIDED|95.0|0.76|1.15|||Log Rank|||||1.15|0.76|0.5392
71052427|NCT03118570|141609395|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.95||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 9||||0.950
71052428|NCT03118570|141609395|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.555||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 9||||0.555
71052429|NCT03118570|141609395|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.221||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.221
71019414|NCT01901146|141546367|EQUIVALENCE|The clinical equivalence between ABP 980 and trastuzumab was first evaluated by comparing the 2-sided 90% CI of the risk difference of pCR between ABP 980 and trastuzumab with a fixed margin of (-13%, 13%).|Risk Difference (RD)|7.3||||0.0508|TWO_SIDED|90.0|1.2|13.4|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||The clinical equivalence between ABP 980 and trastuzumab was first evaluated by comparing the 2-sided 90% confidence interval (CI) of the Risk Difference (RD; ABP 980 - Trastuzumab) of pCR between ABP 980 and trastuzumab with a fixed margin of (-13%, 13%), estimated using a generalized linear model adjusted for stratification factors tumor (T)-stage, nodal status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.||13.4|1.2|0.0508
71019415|NCT01901146|141546367|EQUIVALENCE|If the test of equivalence on the RD of pCR was successful, then equivalence was tested on the risk ratio of pCR at a 2-sided significance level of 0.05 by comparing the 2-sided 90% CI of the RR of pCR between ABP 980 and trastuzumab estimated using a generalized linear model adjusted for stratification factors, with the margin of (0.7586, 1/0.7586). If the test of equivalence on the RD was not successful, the RR of pCR and 90% CI were considered to be descriptive.|Risk Ratio (RR)|1.1877||||0.043|TWO_SIDED|90.0|1.0327|1.366|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||If the test of equivalence on the RD of pCR was successful, then equivalence was tested on the Risk Ratio (RR; ABP 980 / Trastuzumab) of pCR at a 2-sided significance level of 0.05 by comparing the 2-sided 90% CI of the RR of pCR between ABP 980 and trastuzumab, estimated using a generalized linear model adjusted for stratification factors: tumor (T)-stage, nodal status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.||1.3660|1.0327|0.0430
71019416|NCT01901146|141546368|OTHER|Analyses of secondary endpoints were prespecified to be considered descriptive only.|Risk Difference (RD)|6.0||||0.1086|TWO_SIDED|90.0|-0.2|12.2|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||The analysis of risk difference (ABP 980 - Trastuzumab) estimated using a generalized linear model adjusted for the randomization stratification factors T-stage, node status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.||12.2|-0.2|0.1086
71019417|NCT01901146|141546368|OTHER|Analyses of secondary endpoints were prespecified to be considered descriptive only.|Risk Ratio (RR)|1.1463||||0.0807|TWO_SIDED|90.0|1.008|1.3035|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||The analysis of risk ratio (ABP 980 / Trastuzumab) estimated using a generalized linear model adjusted for the randomization stratification factors T-stage, node status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.||1.3035|1.0080|0.0807
71019418|NCT01901146|141546369|OTHER|Analyses of secondary endpoints were prespecified to be considered descriptive only.|Risk Difference (RD)|8.0||||0.0253|TWO_SIDED|90.0|2.1|13.9|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||The analysis of risk difference (ABP 980 - Trastuzumab) estimated using a generalized linear model adjusted for the randomization stratification factors T-stage, node status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.||13.9|2.1|0.0253
71052430|NCT03118570|141609395|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.393||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.393
71052431|NCT03118570|141609395|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.385||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.385
71052432|NCT03118570|141609396|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 1||||< 0.001
71052433|NCT03118570|141609396|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 1||||< 0.001
71052434|NCT03118570|141609396|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 1||||< 0.001
71052435|NCT03118570|141609396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.003||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 3||||0.003
71052436|NCT03118570|141609396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.05||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 3||||0.050
70851265|NCT00669409|141190533|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.2|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-31.6|1.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.2|-31.6|
70932146|NCT02307682|141364349|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-6.3|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||6.1|-6.3|
71052437|NCT03118570|141609396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.006||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 3||||0.006
71052438|NCT03118570|141609396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.519||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.519
71019419|NCT01901146|141546369|OTHER|Analyses of secondary endpoints were prespecified to be considered descriptive only.|Risk Ratio (RR)|1.2746||||0.0245|TWO_SIDED|90.0|1.0673|1.5222|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||The analysis of risk ratio (ABP 980 / Trastuzumab) estimated using a generalized linear model adjusted for the randomization stratification factors T-stage, node status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.||1.5222|1.0673|0.0245
71019420|NCT00297492|141546370|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||Statistical significance was determined by a two-sided p value less than 0.05.|Chi-squared|Degrees of freedom = 2||"Null hypothesis: prolonged abstinence from smoking is the same for the three groups at 6 month follow-up~Sample size was based on an assumption of 6 month abstinence of 25% in the gradual group, 15% in the abrupt group, and 10% in the minimal group. Sample sizes of 300, 300, and 150 for gradual, abrupt, and minimal provides 97% to detect a difference between the groups, with 2-sided alpha = 0.05."||||0.30
71019421|NCT00297492|141546370|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59|||||TWO_SIDED|95.0|0.28|1.22|||||The reported odds ratio represents the odds of 6 month prolonged abstinence in the gradual reduction group divided by the odds of 6 month prolonged abstinence in the abrupt cessation group.|||1.22|0.28|
71019422|NCT02414854|141546371|SUPERIORITY|Hierarchical testing procedure was used to control type I error rate at 0.05 level. The procedure included the 2 primary outcome measures and the first 13 secondary outcome measures reported and considered 2 pair-wise comparisons: Dupilumab 200 mg q2w vs Placebo (for Dupilumab 200 mg) q2w and Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w. Testing order is specified in analysis description.|Relative risk|0.54|||<|0.0001|TWO_SIDED|95.0|0.43|0.68||Hierarchical testing sequence performed continued only when previous outcome measures was statistically significant at 0.05. Threshold for significance at 0.05 level.|Negative binomial regression model||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 1 of testing order.||0.68|0.43|<0.0001
71019423|NCT02414854|141546371|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|Relative risk|0.523|||<|0.0001|TWO_SIDED|95.0|0.413|0.662||Threshold for significance at 0.05 level.|Negative binomial regression model||Dupilumab 200 mg q2w vs Placebo (for Dupilumab 200 mg) q2w|Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 3 of testing order.||0.662|0.413|<0.0001
71052439|NCT03118570|141609396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.226||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.226
71052440|NCT03118570|141609396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.19||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.190
71052441|NCT03118570|141609396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.388||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 9||||0.388
71052442|NCT03118570|141609396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.109||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 9||||0.109
71052443|NCT03118570|141609396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.204||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 9||||0.204
71052444|NCT03118570|141609396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.119||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.119
71052445|NCT03118570|141609396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.925||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.925
71052446|NCT03118570|141609396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.204||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.204
70851266|NCT00669409|141190533|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-40.8|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-62.6|-19.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-19.0|-62.6|
71052447|NCT03118570|141609397|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.588||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.588
71052448|NCT03118570|141609397|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.697||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.697
71052449|NCT03118570|141609397|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.283||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.283
71019424|NCT02414854|141546372|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|Least Square (LS) Mean Difference|0.13|||<|0.0001|TWO_SIDED|95.0|0.08|0.18||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using mixed-effect model with repeated measures (MMRM) model with change from baseline in FEV1 values up to Week 12 as response variable; and treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value and baseline-by-visit interaction as covariates. Here, it is test no. 2 of testing order.||0.18|0.08|<0.0001
71019425|NCT02414854|141546372|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|LS Mean Difference|0.14|||<|0.0001|TWO_SIDED|95.0|0.08|0.19||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 200 mg q2w vs Placebo (for Dupilumab 200 mg) q2w|Analysis was performed using MMRM model with change from baseline in FEV1 values up to Week 12 as response variable; and treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value and baseline-by-visit interaction as covariates. Here, it is test no. 4 of testing order.||0.19|0.08|<0.0001
71019426|NCT02414854|141546373|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|LS Mean Difference|9.41|||<|0.0001|TWO_SIDED|95.0|5.74|13.07||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis performed using MMRM model(n=954 for 300 vs placebo)with percent change from baseline in FEV1 values up to Week 12 as response variable; \& treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value \& baseline-by-visit interaction as covariates. Hierarchical testing procedure used to control type I error \& handle multiple secondary endpoint analyses. Here, it is test no. 5 of testing order.||13.07|5.74|<0.0001
71019427|NCT02414854|141546374|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|Relative risk|0.402|||<|0.0001|TWO_SIDED|95.0|0.307|0.526||Threshold for significance at 0.05 level.|Negative binomial regression model||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 6 of testing order.||0.526|0.307|<0.0001
71019428|NCT02414854|141546375|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|LS Mean Difference|0.15|||<|0.0001|TWO_SIDED|95.0|0.09|0.21||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using MMRM model with change from baseline in FEV1 values up to Week 12 as response variable; and treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value and baseline-by-visit interaction as covariates. Here, it is test no. 7 of testing order.||0.21|0.09|<0.0001
71019429|NCT02414854|141546376|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|Relative risk|0.326|||<|0.0001|TWO_SIDED|95.0|0.234|0.454||Threshold for significance at 0.05 level.|Negative binomial regression model||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 8 of testing order.||0.454|0.234|<0.0001
71019430|NCT02414854|141546377|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|LS Mean Difference|0.24|||<|0.0001|TWO_SIDED|95.0|0.16|0.32||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using MMRM model with change from baseline in FEV1 values up to Week 12 as response variable; and treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value and baseline-by-visit interaction as covariates. Here, it is test no. 9 of testing order.||0.32|0.16|<0.0001
71019431|NCT02414854|141546378|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|Relative risk|0.834||||0.2599|TWO_SIDED|95.0|0.608|1.144||Threshold for significance at 0.05 level.|Negative binomial regression model||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 10 of testing order.||1.144|0.608|0.2599
71052450|NCT03118570|141609397|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.354||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.354
71052451|NCT03118570|141609397|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.43||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.430
71052452|NCT03118570|141609397|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.091||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.091
71019432|NCT00606801|141546410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.006
71117611|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
71019433|NCT00606801|141546411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.04
71019434|NCT00606801|141546412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.02
71019435|NCT00606801|141546413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.03
71019436|NCT00606801|141546414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.5
71019437|NCT00606801|141546415|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.7
71019438|NCT00606801|141546416|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.3
71019439|NCT00606801|141546417|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.3
71019440|NCT00606801|141546418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.3
71019441|NCT00606801|141546419|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.9
71019442|NCT00606801|141546420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.8
71019443|NCT00606801|141546421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.5
71019444|NCT00606801|141546422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.01
70932147|NCT02307682|141364349|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-7.2|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||5.6|-7.2|
70932148|NCT02307682|141364349|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-8.5|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||4.3|-8.5|
70932149|NCT02307682|141364349|OTHER||Difference in proportions|4.0|||||TWO_SIDED|95.0|-2.4|10.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||10.2|-2.4|
70932150|NCT02307682|141364349|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-5.1|7.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||7.8|-5.1|
70932151|NCT02307682|141364349|OTHER||Difference in proportions|3.9|||||TWO_SIDED|95.0|-2.5|9.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||9.6|-2.5|
70932152|NCT02307682|141364349|OTHER||Difference in proportions|2.4|||||TWO_SIDED|95.0|-3.5|9.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||9.0|-3.5|
70932153|NCT02307682|141364349|OTHER||Difference in proportions|3.3|||||TWO_SIDED|95.0|-3.0|9.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||9.0|-3.0|
70932154|NCT02307682|141364349|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-5.8|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||6.4|-5.8|
70932155|NCT02307682|141364349|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-6.6|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||6.5|-6.6|
70932156|NCT02307682|141364349|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-6.0|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||6.1|-6.0|
70932157|NCT02307682|141364349|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-2.8|9.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||9.5|-2.8|
70932158|NCT02307682|141364349|OTHER||Difference in proportions|1.8|||||TWO_SIDED|95.0|-4.3|8.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||8.0|-4.3|
70932159|NCT02307682|141364349|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-4.7|7.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||7.8|-4.7|
70932160|NCT02307682|141364349|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-3.8|9.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||9.0|-3.8|
70932161|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-7.9|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-24.2|8.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4||8.4|-24.2|
70932162|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-16.5|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-31.9|-1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4||-1.1|-31.9|
70932163|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-13.7|STANDARD_ERROR_OF_MEAN|8.51|||TWO_SIDED|95.0|-30.4|3.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 8||3.0|-30.4|
71019445|NCT00606801|141546423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.60
71106000|NCT02164864|141718574|NON_INFERIORITY|All non-inferiority tests were based on a margin of 1.38.|Hazard Ratio (HR)|0.72|||<|0.0001|TWO_SIDED|95.0|0.58|0.88||P-values for non-inferiority were calculated at a one-sided alpha level of 0.025|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|A pre-defined hierarchical testing approach was used. This was the second step in hierarchy. The upper bound of the Wald confidence interval (CI) of the HR of Dabigatran Etexilate 150mg vs Warfarin (one-sided 97.5%) was compared with this noninferiority margin for the testing of non-inferiority||0.88|0.58|<.0001
70932164|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-19.0|STANDARD_ERROR_OF_MEAN|8.16|||TWO_SIDED|95.0|-35.0|-2.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8||-2.9|-35.0|
71106001|NCT02164864|141718574|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.42|0.63||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|A pre-defined hierarchical testing approach was used. This was the fourth step in hierarchy.||0.63|0.42|<0.001
71106002|NCT02164864|141718574|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.002|TWO_SIDED|95.0|0.58|0.88||unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded|Regression, Cox|Wald 2-sided p-value from (unstratified) Cox proportional hazards model||A pre-defined hierarchical testing approach was used. This was the sixth step in hierarchy.|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|0.88|0.58|0.0020
71106003|NCT02164864|141718575|OTHER||Hazard Ratio (HR)|0.99||||0.9862|TWO_SIDED|95.0|0.25|3.95||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||3.95|0.25|0.9862
71106004|NCT02164864|141718575|OTHER|Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Hazard Ratio (HR)|1.59||||0.5277|TWO_SIDED|95.0|0.38|6.64|||Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||6.64|0.38|0.5277
71106005|NCT02164864|141718576|OTHER||Hazard Ratio (HR)|1.06||||0.8853|TWO_SIDED|95.0|0.5|2.25||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.25|0.50|0.8853
71106006|NCT02164864|141718576|OTHER||Hazard Ratio (HR)|0.49||||0.238|TWO_SIDED|95.0|0.15|1.61||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.61|0.15|0.2380
71106007|NCT02164864|141718577|OTHER||Hazard Ratio (HR)|1.17||||0.5252|TWO_SIDED|95.0|0.72|1.88||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.88|0.72|0.5252
70932165|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-19.7|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-36.3|-3.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12||-3.1|-36.3|
71106008|NCT02164864|141718577|OTHER||Hazard Ratio (HR)|0.84||||0.567|TWO_SIDED|95.0|0.47|1.51||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.51|0.47|0.5670
71106009|NCT02164864|141718578|OTHER||Hazard Ratio (HR)|1.12||||0.5579|TWO_SIDED|95.0|0.76|1.65||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.65|0.76|0.5579
71106010|NCT02164864|141718578|OTHER||Hazard Ratio (HR)|0.83||||0.4414|TWO_SIDED|95.0|0.51|1.34||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.34|0.51|0.4414
70851267|NCT00669409|141190534|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-20.9|12.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.5|-20.9|
70851268|NCT00669409|141190534|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.9|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-32.6|0.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.7|-32.6|
70932166|NCT02307682|141364350|OTHER||Least Squares Mean Difference|-24.5|STANDARD_ERROR_OF_MEAN|8.24|||TWO_SIDED|95.0|-40.7|-8.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||-8.3|-40.7|
71019446|NCT00606801|141546424|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.50
71019447|NCT02016755|141546442|SUPERIORITY|||||||0.331|||||||t-test, 2 sided|||Overall (LOCF)||||0.331
71019448|NCT02016755|141546442|SUPERIORITY|||||||0.362|||||||t-test, 2 sided|||Activity (LOCF)||||0.362
71019449|NCT02016755|141546442|SUPERIORITY|||||||0.159|||||||t-test, 2 sided|||Emotional (LOCF)||||0.159
71019450|NCT02016755|141546442|SUPERIORITY|||||||0.468|||||||t-test, 2 sided|||Pain (LOCF)||||0.468
71019451|NCT02016755|141546442|SUPERIORITY|||||||0.197|||||||t-test, 2 sided|||Social (LOCF)||||0.197
71019452|NCT02016755|141546442|SUPERIORITY|||||||0.448|||||||t-test, 2 sided|||Symptom (LOCF)||||0.448
70932167|NCT02307682|141364350|SUPERIORITY||Least Squares Mean Difference|-19.9|STANDARD_ERROR_OF_MEAN|9.24||0.0159|TWO_SIDED|95.0|-38.0|-1.7||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 16||-1.7|-38.0|0.0159
70932168|NCT02307682|141364350|SUPERIORITY||Least Squares Mean Difference|-27.8|STANDARD_ERROR_OF_MEAN|8.8||0.0008|TWO_SIDED|95.0|-45.1|-10.5||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16||-10.5|-45.1|0.0008
70932169|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|5.2|STANDARD_ERROR_OF_MEAN|8.69|||TWO_SIDED|95.0|-11.8|22.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 20||22.3|-11.8|
70932170|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|8.8|||TWO_SIDED|95.0|-14.1|20.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20||20.5|-14.1|
70932171|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-25.8|STANDARD_ERROR_OF_MEAN|9.44|||TWO_SIDED|95.0|-44.3|-7.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 24||-7.2|-44.3|
70932172|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-29.6|STANDARD_ERROR_OF_MEAN|9.13|||TWO_SIDED|95.0|-47.5|-11.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||-11.6|-47.5|
70932173|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-11.6|STANDARD_ERROR_OF_MEAN|8.96|||TWO_SIDED|95.0|-29.2|5.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 28||5.9|-29.2|
71019453|NCT02016755|141546443|SUPERIORITY|||||||0.939|||||||t-test, 2 sided|||Change from Baseline at Month 3||||0.939
71019454|NCT02016755|141546443|SUPERIORITY|||||||0.508|||||||t-test, 2 sided|||Change from Baseline at Month 6||||0.508
71019455|NCT02016755|141546443|SUPERIORITY|||||||0.474|||||||t-test, 2 sided|||Change from Baseline at Month 9||||0.474
71019456|NCT02016755|141546443|SUPERIORITY|||||||0.361|||||||t-test, 2 sided|||Change from Baseline at Month 12||||0.361
71019457|NCT02016755|141546443|SUPERIORITY|||||||0.258|||||||t-test, 2 sided|||Change from Baseline at Month 15||||0.258
71019458|NCT02016755|141546443|SUPERIORITY|||||||0.059|||||||t-test, 2 sided|||Change from baseline at Month 18||||0.059
71019459|NCT02016755|141546443|SUPERIORITY|||||||0.023|||||||t-test, 2 sided|||Change from Baseline at LOCF||||0.023
71019460|NCT02016755|141546444|SUPERIORITY|||||||0.655|||||||t-test, 2 sided|||Change from Baseline at Month 3 (Dorsalis pedis)||||0.655
71019461|NCT02016755|141546444|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||Change from Baseline at Month 6 (Dorsalis pedis)||||0.310
71019462|NCT02016755|141546444|SUPERIORITY|||||||0.348|||||||t-test, 2 sided|||Change from Baseline at Month 9 (Dorsalis pedis)||||0.348
71019463|NCT02016755|141546444|SUPERIORITY|||||||0.501|||||||t-test, 2 sided|||Change from Baseline at Month 12 (Dorsalis pedis)||||0.501
71019464|NCT02016755|141546444|SUPERIORITY|||||||0.536|||||||t-test, 2 sided|||Change from Baseline at Month 15 (Dorsalis pedis)||||0.536
71019465|NCT02016755|141546444|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||Change from Baseline at Month 18 (Dorsalis pedis)||||0.140
71019466|NCT02016755|141546444|SUPERIORITY|||||||0.018|||||||t-test, 2 sided|||Change from Baseline at LOCF (Dorsalis pedis)||||0.018
71019467|NCT02016755|141546444|SUPERIORITY|||||||0.716|||||||t-test, 2 sided|||Change from baseline at Month 3 (Posterior tibial)||||0.716
71019468|NCT02016755|141546444|SUPERIORITY|||||||0.641|||||||t-test, 2 sided|||Change from baseline at Month 6 (Posterior tibial)||||0.641
70932174|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-12.1|STANDARD_ERROR_OF_MEAN|8.98|||TWO_SIDED|95.0|-29.8|5.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28||5.5|-29.8|
71106011|NCT02164864|141718579|OTHER|Wald 2-sided p-value from (stratified) Cox proportional hazards model|Hazard Ratio (HR)|1.51||||0.0861|TWO_SIDED|95.0|0.94|2.41|||Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.41|0.94|0.0861
70932175|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-20.1|STANDARD_ERROR_OF_MEAN|9.91|||TWO_SIDED|95.0|-39.6|-0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 32||-0.7|-39.6|
70932176|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-23.2|STANDARD_ERROR_OF_MEAN|9.64|||TWO_SIDED|95.0|-42.1|-4.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32||-4.2|-42.1|
70932177|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-17.4|STANDARD_ERROR_OF_MEAN|9.24|||TWO_SIDED|95.0|-35.5|0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 36||0.7|-35.5|
70932178|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-19.6|STANDARD_ERROR_OF_MEAN|9.14|||TWO_SIDED|95.0|-37.6|-1.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36||-1.7|-37.6|
70932179|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-27.3|STANDARD_ERROR_OF_MEAN|9.83|||TWO_SIDED|95.0|-46.6|-8.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 40||-8.0|-46.6|
70932180|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-29.5|STANDARD_ERROR_OF_MEAN|9.5|||TWO_SIDED|95.0|-48.2|-10.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40||-10.9|-48.2|
70932181|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-9.3|STANDARD_ERROR_OF_MEAN|9.27|||TWO_SIDED|95.0|-27.5|8.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 44||8.9|-27.5|
70932182|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-11.4|STANDARD_ERROR_OF_MEAN|9.64|||TWO_SIDED|95.0|-30.3|7.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44||7.5|-30.3|
70932183|NCT02307682|141364350|SUPERIORITY||Least Squares Mean Difference|-23.9|STANDARD_ERROR_OF_MEAN|9.79||0.0075|TWO_SIDED|95.0|-43.1|-4.6||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 48||-4.6|-43.1|0.0075
71019469|NCT02016755|141546444|SUPERIORITY|||||||0.514|||||||t-test, 2 sided|||Change from baseline at Month 9 (Posterior tibial)||||0.514
71019470|NCT02016755|141546444|SUPERIORITY|||||||0.808|||||||t-test, 2 sided|||Change from baseline at Month 12 (Posterior tibial)||||0.808
71019471|NCT02016755|141546444|SUPERIORITY|||||||0.396|||||||t-test, 2 sided|||Change from baseline at Month 15 (Posterior tibial)||||0.396
71019472|NCT02016755|141546444|SUPERIORITY|||||||0.162|||||||t-test, 2 sided|||Change from baseline at Month 18 (Posterior tibial)||||0.162
71019473|NCT02016755|141546444|SUPERIORITY|||||||0.259|||||||t-test, 2 sided|||Change from baseline at LOCF (Posterior tibial)||||0.259
71019474|NCT02016755|141546445|SUPERIORITY|||||||0.671|||||||t-test, 2 sided|||Change from Baseline at Month 3||||0.671
71019475|NCT02016755|141546445|SUPERIORITY|||||||0.925|||||||t-test, 2 sided|||Change from Baseline at Month 6||||0.925
71019476|NCT02016755|141546445|SUPERIORITY|||||||0.514|||||||t-test, 2 sided|||Change from Baseline at Month 9||||0.514
71019477|NCT02016755|141546445|SUPERIORITY|||||||0.302|||||||t-test, 2 sided|||Change from Baseline at Month 12||||0.302
71019478|NCT02016755|141546445|SUPERIORITY|||||||0.373|||||||t-test, 2 sided|||Change from Baseline at Month 15||||0.373
71019479|NCT02016755|141546445|SUPERIORITY|||||||0.505|||||||t-test, 2 sided|||Change from Baseline at Month 18||||0.505
71019480|NCT02016755|141546445|SUPERIORITY|||||||0.135|||||||t-test, 2 sided|||Change from Baseline at LOCF||||0.135
71019481|NCT02016755|141546445|SUPERIORITY|||||||0.175|||||||t-test, 2 sided|||Change from baseline at month 3 (Left)||||0.175
71019482|NCT02016755|141546445|SUPERIORITY|||||||0.393|||||||t-test, 2 sided|||Change from baseline at month 6 (Left)||||0.393
71019483|NCT02016755|141546445|SUPERIORITY|||||||0.928|||||||t-test, 2 sided|||Change from baseline at month 9 (Left)||||0.928
71019484|NCT02016755|141546445|SUPERIORITY|||||||0.429|||||||t-test, 2 sided|||Change from baseline at month 12 (Left)||||0.429
71019485|NCT02016755|141546445|SUPERIORITY|||||||0.907|||||||t-test, 2 sided|||Change from baseline at month 15 (Left)||||0.907
71019486|NCT02016755|141546445|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||Change from baseline at month 18 (Left)||||0.300
71019487|NCT02016755|141546445|SUPERIORITY|||||||0.214|||||||t-test, 2 sided|||Change from baseline at LOCF (Left)||||0.214
71019488|NCT02016755|141546446|SUPERIORITY|||||||0.655|||||||t-test, 2 sided|||Change from Baseline at Month 3||||0.655
71019489|NCT02016755|141546446|SUPERIORITY|||||||0.226|||||||t-test, 2 sided|||Change from Baseline at Month 6||||0.226
70932184|NCT02307682|141364350|SUPERIORITY||Least Squares Mean Difference|-29.0|STANDARD_ERROR_OF_MEAN|9.47||0.0012|TWO_SIDED|95.0|-47.6|-10.4||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||-10.4|-47.6|0.0012
70932185|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-15.6|STANDARD_ERROR_OF_MEAN|9.17|||TWO_SIDED|95.0|-33.6|2.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 52||2.4|-33.6|
70932186|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-15.1|STANDARD_ERROR_OF_MEAN|9.35|||TWO_SIDED|95.0|-33.4|3.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52||3.3|-33.4|
70932187|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-20.0|STANDARD_ERROR_OF_MEAN|9.62|||TWO_SIDED|95.0|-38.9|-1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 56||-1.1|-38.9|
70932188|NCT02307682|141364350|OTHER||Least Squares Mean Difference|-20.0|STANDARD_ERROR_OF_MEAN|9.86|||TWO_SIDED|95.0|-39.4|-0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56||-0.7|-39.4|
70932189|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-18.8|STANDARD_ERROR_OF_MEAN|9.3|||TWO_SIDED|95.0|-37.0|-0.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 60||-0.5|-37.0|
70932190|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-12.7|STANDARD_ERROR_OF_MEAN|9.56|||TWO_SIDED|95.0|-31.4|6.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60||6.1|-31.4|
70932191|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-27.2|STANDARD_ERROR_OF_MEAN|9.96|||TWO_SIDED|95.0|-46.7|-7.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 64||-7.6|-46.7|
70932192|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-22.5|STANDARD_ERROR_OF_MEAN|9.73|||TWO_SIDED|95.0|-41.6|-3.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64||-3.4|-41.6|
70932193|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-14.9|STANDARD_ERROR_OF_MEAN|9.6|||TWO_SIDED|95.0|-33.8|3.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 68||3.9|-33.8|
70932194|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-13.2|STANDARD_ERROR_OF_MEAN|9.88|||TWO_SIDED|95.0|-32.6|6.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68||6.2|-32.6|
70932195|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-29.9|STANDARD_ERROR_OF_MEAN|9.89|||TWO_SIDED|95.0|-49.3|-10.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 72||-10.5|-49.3|
70932196|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-26.4|STANDARD_ERROR_OF_MEAN|9.99|||TWO_SIDED|95.0|-46.0|-6.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||-6.8|-46.0|
70932197|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-19.3|STANDARD_ERROR_OF_MEAN|9.62|||TWO_SIDED|95.0|-38.2|-0.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 76||-0.4|-38.2|
70932198|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-15.7|STANDARD_ERROR_OF_MEAN|9.84|||TWO_SIDED|95.0|-35.0|3.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76||3.7|-35.0|
70932199|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-24.8|STANDARD_ERROR_OF_MEAN|10.34|||TWO_SIDED|95.0|-45.0|-4.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 80||-4.5|-45.0|
70932200|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-23.7|STANDARD_ERROR_OF_MEAN|10.32|||TWO_SIDED|95.0|-43.9|-3.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80||-3.4|-43.9|
70932201|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-19.5|STANDARD_ERROR_OF_MEAN|9.65|||TWO_SIDED|95.0|-38.4|-0.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 84||-0.5|-38.4|
71019490|NCT02016755|141546446|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||Change from Baseline at Month 9||||0.380
71106012|NCT02164864|141718579|OTHER||Hazard Ratio (HR)|1.16||||0.6144|TWO_SIDED|95.0|0.66|2.04||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.04|0.66|0.6144
71106013|NCT02164864|141718580|OTHER||Hazard Ratio (HR)|1.3||||0.4803|TWO_SIDED|95.0|0.63|2.67||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.67|0.63|0.4803
71106014|NCT02164864|141718580|OTHER||Hazard Ratio (HR)|1.09||||0.8537|TWO_SIDED|95.0|0.42|2.83||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.83|0.42|0.8537
70932202|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-11.8|STANDARD_ERROR_OF_MEAN|10.05|||TWO_SIDED|95.0|-31.5|8.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84||8.0|-31.5|
70932203|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-27.3|STANDARD_ERROR_OF_MEAN|10.16|||TWO_SIDED|95.0|-47.3|-7.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 88||-7.4|-47.3|
70932204|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-24.2|STANDARD_ERROR_OF_MEAN|10.22|||TWO_SIDED|95.0|-44.3|-4.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88||-4.2|-44.3|
70932205|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-15.1|STANDARD_ERROR_OF_MEAN|9.7|||TWO_SIDED|95.0|-34.2|3.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 92||3.9|-34.2|
70932206|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-12.5|STANDARD_ERROR_OF_MEAN|9.99|||TWO_SIDED|95.0|-32.1|7.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92||7.1|-32.1|
70932207|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-30.9|STANDARD_ERROR_OF_MEAN|10.0|||TWO_SIDED|95.0|-50.6|-11.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 96||-11.3|-50.6|
70932208|NCT02307682|141364350|OTHER|Treatment difference|Least Squares Mean Difference|-26.0|STANDARD_ERROR_OF_MEAN|10.28|||TWO_SIDED|95.0|-46.2|-5.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||-5.9|-46.2|
70932209|NCT02307682|141364351|SUPERIORITY||Least Squares Mean Difference|-19.5|STANDARD_ERROR_OF_MEAN|9.29||0.0183|TWO_SIDED|95.0|-37.7|-1.2||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|||-1.2|-37.7|0.0183
71106015|NCT02164864|141718581|OTHER||Hazard Ratio (HR)|0.94||||0.9388|TWO_SIDED|95.0|0.19|4.66||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||4.66|0.19|0.9388
70932210|NCT02307682|141364351|SUPERIORITY||Least Squares Mean Difference|-22.4|STANDARD_ERROR_OF_MEAN|9.19||0.0075|TWO_SIDED|95.0|-40.4|-4.4||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||-4.4|-40.4|0.0075
71106016|NCT02164864|141718581|OTHER||Hazard Ratio (HR)|0.3||||0.303|TWO_SIDED|95.0|0.03|2.93||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.93|0.03|0.3030
70932211|NCT02307682|141364352|OTHER|Treatment difference|Least Squares Mean Difference|-23.2|STANDARD_ERROR_OF_MEAN|9.76|||TWO_SIDED|95.0|-42.4|-4.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|||-4.1|-42.4|
70932212|NCT02307682|141364352|OTHER|Treatment difference|Least Squares Mean Difference|-18.6|STANDARD_ERROR_OF_MEAN|10.0|||TWO_SIDED|95.0|-38.3|1.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||1.0|-38.3|
70932213|NCT02307682|141364353|OTHER|Treatment difference|Least Squares Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|8.5|||TWO_SIDED|95.0|-32.6|0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4 to Week 48||0.7|-32.6|
71019491|NCT02016755|141546446|SUPERIORITY|||||||0.187|||||||t-test, 2 sided|||Change from Baseline at Month 12||||0.187
71019492|NCT02016755|141546446|SUPERIORITY|||||||0.203|||||||t-test, 2 sided|||Change from Baseline at Month 15||||0.203
70932214|NCT02307682|141364353|OTHER|Treatment difference|Least Squares Mean Difference|-19.9|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-36.5|-3.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 48||-3.3|-36.5|
70932215|NCT02307682|141364353|OTHER|Treatment difference|Least Squares Mean Difference|-18.9|STANDARD_ERROR_OF_MEAN|8.87|||TWO_SIDED|95.0|-36.4|-1.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4 to Week 96||-1.5|-36.4|
70932216|NCT02307682|141364353|OTHER|Treatment difference|Least Squares Mean Difference|-19.3|STANDARD_ERROR_OF_MEAN|8.93|||TWO_SIDED|95.0|-36.9|-1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 96||-1.8|-36.9|
70932217|NCT02307682|141364354|OTHER|Treatment difference|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|-0.8|0.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12||0.1|-0.8|
70932218|NCT02307682|141364354|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-1.0|-0.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||-0.2|-1.0|
71019493|NCT02016755|141546446|SUPERIORITY|||||||0.074|||||||t-test, 2 sided|||Change from Baseline at Month 18||||0.074
71019494|NCT02016755|141546446|SUPERIORITY|||||||0.038|||||||t-test, 2 sided|||Change from Baseline at LOCF||||0.038
71019495|NCT02016755|141546447|SUPERIORITY|||||||0.246|||||||t-test, 2 sided|||Change from Baseline at Month 3||||0.246
71019496|NCT02016755|141546447|SUPERIORITY|||||||0.474|||||||t-test, 2 sided|||Change from Baseline at Month 6||||0.474
71019497|NCT02016755|141546447|SUPERIORITY|||||||0.395|||||||t-test, 2 sided|||Change from Baseline at Month 9||||0.395
71019498|NCT02016755|141546447|SUPERIORITY|||||||0.22|||||||t-test, 2 sided|||Change from Baseline at Month 12||||0.220
70932219|NCT02307682|141364354|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|-1.1|-0.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 48||-0.2|-1.1|
70932220|NCT02307682|141364354|OTHER|Treatment difference|Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-0.9|0.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||0.0|-0.9|
71019499|NCT02016755|141546447|SUPERIORITY|||||||0.454|||||||t-test, 2 sided|||Change from Baseline at Month 15||||0.454
71019500|NCT02016755|141546447|SUPERIORITY|||||||0.167|||||||t-test, 2 sided|||Change from Baseline at Month 18||||0.167
71019501|NCT02016755|141546447|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|||Change from Baseline at LOCF||||0.015
71019502|NCT02533505|141546468|SUPERIORITY||Mean Difference (Final Values)|10.114||||0.007|TWO_SIDED|95.0|2.943|17.286||All p-values ≤ 0.05 after rounding will be considered statistically significant.|Mixed Models Analysis|||||17.286|2.943|0.007
71052453|NCT03118570|141609398|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.527||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.527
70851269|NCT00669409|141190534|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-13.2|20.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.1|-13.2|
71019503|NCT02533505|141546469|SUPERIORITY||Mean Difference (Final Values)|0.087||||0.111|TWO_SIDED|95.0|-0.021|0.196|||Mixed Models Analysis|||||0.196|-0.021|0.111
71019504|NCT02533505|141546470|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.609|TWO_SIDED|95.0|-1.018|1.719|||Mixed Models Analysis|||ΔHR||1.719|-1.018|0.609
71019505|NCT02533505|141546471|SUPERIORITY||Mean Difference (Final Values)|0.191|||<|0.001|TWO_SIDED|95.0|0.15|0.233|||Mixed Models Analysis|||ΔFEV1||0.233|0.150|<0.001
71019506|NCT02533505|141546471|SUPERIORITY||Mean Difference (Final Values)|0.312|||<|0.001|TWO_SIDED|95.0|0.236|0.388|||Mixed Models Analysis|||ΔFVC||0.388|0.236|<0.001
71019507|NCT02533505|141546471|SUPERIORITY||Mean Difference (Final Values)|0.28|||<|0.001|TWO_SIDED|95.0|0.218|0.342|||Mixed Models Analysis|||ΔIC||0.342|0.218|<0.001
71019508|NCT02533505|141546472|SUPERIORITY||Mean Difference (Final Values)|23.315||||0.021|TWO_SIDED|95.0|3.723|42.907|||Mixed Models Analysis|||ΔVT/Ti||42.907|3.723|0.021
71019509|NCT02533505|141546473|SUPERIORITY||Mean Difference (Final Values)|-0.204||||0.106|TWO_SIDED|95.0|-0.454|0.045|||Mixed Models Analysis|||||0.045|-0.454|0.106
71019510|NCT02533505|141546474|SUPERIORITY||Mean Difference (Final Values)|10.245||||0.011|TWO_SIDED|95.0|2.469|18.021|||Mixed Models Analysis|||ΔVCO2||18.021|2.469|0.011
71019511|NCT02533505|141546475|SUPERIORITY||Mean Difference (Final Values)|0.242||||0.333|TWO_SIDED|95.0|-0.255|0.738|||Mixed Models Analysis|||ΔSaO2||0.738|-0.255|0.333
71019512|NCT02533505|141546476|SUPERIORITY||Mean Difference (Final Values)|0.237||||0.484|TWO_SIDED|95.0|-0.439|0.913|||Mixed Models Analysis|||ΔRR||0.913|-0.439|0.484
71019513|NCT02533505|141546477|SUPERIORITY||Mean Difference (Final Values)|0.016||||0.113|TWO_SIDED|95.0|-0.004|0.036|||Mixed Models Analysis|||ΔTi/Ttot||0.036|-0.004|0.113
71019514|NCT02533505|141546478|SUPERIORITY||Mean Difference (Final Values)|57.624|||<|0.001|TWO_SIDED|95.0|29.701|85.546|||Mixed Models Analysis|||ΔVt||85.546|29.701|<0.001
71019515|NCT02533505|141546479|SUPERIORITY||Mean Difference (Final Values)|862.157|||<|0.001|TWO_SIDED|95.0|439.817|1284.496|||Mixed Models Analysis|||ΔVe||1284.496|439.817|<0.001
71019516|NCT02533505|141546480|SUPERIORITY||Mean Difference (Final Values)|0.019||||0.007|TWO_SIDED|95.0|0.005|0.033|||Mixed Models Analysis|||ΔFEV1/FVC||0.033|0.005|0.007
70932221|NCT02307682|141364354|OTHER|Treatment difference|Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-1.3|-0.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 96||-0.3|-1.3|
71019517|NCT00337129|141546481|SUPERIORITY_OR_OTHER||Response probability|0.05|||||TWO_SIDED|95.0|0.01|0.17|||two-stage binomial|||Null hypothesis: response probability \< 5%; alternative hypothesis: response probability \> 20%. A two-stage design was used. If no responses among the first 20 patients, the study would be terminated with the conclusion that E7389 is inactive. However, if at least one response was seen then an additional 20 patients would be accrued. Five or more responses out of 40 would be considered evidence that E7389 warranted further study. This design had a significance level of 5% and a power of 92%.||0.17|0.01|
71019518|NCT01467570|141546502|NON_INFERIORITY_OR_EQUIVALENCE|The differences between study groups were considered significant when the p value was \<0.05 or when the 95% CI for RD or MD did not include 0 (equivalent to p \< 0.05).||||||0.28|||||||t-test, 1 sided|||||||0.28
71052454|NCT03118570|141609398|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.738||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.738
70932222|NCT02307682|141364354|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|-1.1|-0.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||-0.3|-1.1|
71052455|NCT03118570|141609398|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.465||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.465
71052456|NCT03118570|141609398|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.068||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.068
71052457|NCT03118570|141609398|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.328||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.328
71052458|NCT03118570|141609398|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.277||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.277
71052459|NCT03118570|141609399|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.092||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.092
71052460|NCT03118570|141609399|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.31||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.310
71052461|NCT03118570|141609399|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.304||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.304
70932223|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|7.1|STANDARD_ERROR_OF_MEAN|5.31|||TWO_SIDED|95.0|-3.3|17.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4||17.5|-3.3|
71052462|NCT03118570|141609399|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.155||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.155
71052463|NCT03118570|141609399|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.392||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.392
71019519|NCT01222715|141546517|SUPERIORITY_OR_OTHER|||||||0.0124|TWO_SIDED|95.0|||||Log Rank|||The event free survival distributions of patients in Regimen A and Regimen B were compared using the log-rank test.||||0.0124
71052464|NCT03118570|141609399|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.464||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.464
71052465|NCT03118570|141609400|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.15||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.150
71052466|NCT03118570|141609400|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.468||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.468
71052467|NCT03118570|141609400|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.8||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.800
71052468|NCT03118570|141609400|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.563||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.563
70932224|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|5.37|||TWO_SIDED|95.0|-10.2|10.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4||10.9|-10.2|
70932225|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|5.35|||TWO_SIDED|95.0|-8.4|12.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 8||12.6|-8.4|
70932226|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|5.52|||TWO_SIDED|95.0|-12.5|9.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8||9.2|-12.5|
70932227|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|5.38|||TWO_SIDED|95.0|-11.2|10.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12||10.0|-11.2|
71019520|NCT03372369|141546526|SUPERIORITY||||||<|0.0001||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the contraceptive knowledge score for the CDC poster between baseline and followup is 0.||||<0.0001
71106017|NCT02164864|141718582|OTHER||Hazard Ratio (HR)|1.86||||0.1546|TWO_SIDED|95.0|0.79|4.4||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||4.40|0.79|0.1546
71106018|NCT02164864|141718582|OTHER||Hazard Ratio (HR)|0.99||||0.9789|TWO_SIDED|95.0|0.35|2.81||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.81|0.35|0.9789
70932228|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|5.55|||TWO_SIDED|95.0|-13.9|7.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||7.9|-13.9|
70932229|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|5.73|||TWO_SIDED|95.0|-11.1|11.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 16||11.4|-11.1|
71019521|NCT03372369|141546526|SUPERIORITY||||||<|0.0001||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the contraceptive knowledge score for the patient-centered poster between baseline and followup is 0.||||<0.0001
71019522|NCT03372369|141546526|SUPERIORITY||||||<|0.0001||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the patient-centered poster does not produce a larger increase in the contraceptive knowledge score between baseline and followup than the CDC poster.||||<0.0001
71019523|NCT03372369|141546527|SUPERIORITY||||||<|0.001||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the effective contraception preference score for the CDC poster between baseline and followup is 0.||||<0.001
71019524|NCT03372369|141546527|SUPERIORITY||||||<|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the effective contraception preference score for the patient-centered poster between baseline and followup is 0.||||<0.01
71019525|NCT03372369|141546527|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the patient-centered poster does not produce a larger increase in the effective contraception preference score between baseline and followup than the CDC poster.||||>0.01
71019526|NCT03372369|141546528|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the perceived pregnancy risk score for the CDC poster between baseline and followup is 0.||||>0.01
71019527|NCT03372369|141546528|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the perceived pregnancy risk score for the patient-centered poster between baseline and followup is 0.||||>0.01
71019528|NCT03372369|141546528|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the patient-centered poster does not produce a larger increase in the perceived pregnancy risk score between baseline and followup than the CDC poster.||||>0.01
70932230|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|5.76|||TWO_SIDED|95.0|-16.1|6.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16||6.5|-16.1|
71052469|NCT03118570|141609400|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.839||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.839
71052470|NCT03118570|141609400|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.186||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.186
71052471|NCT03118570|141609401|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.278||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.278
71052472|NCT03118570|141609401|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.292||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.292
71052473|NCT03118570|141609401|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.115||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.115
71052474|NCT03118570|141609401|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.356||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.356
71052475|NCT03118570|141609401|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.205||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.205
71052476|NCT03118570|141609401|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.078||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.078
71106019|NCT02164864|141718583|OTHER||Hazard Ratio (HR)|1.34||||0.0484|TWO_SIDED|95.0|1.0|1.79||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.79|1.00|0.0484
71106020|NCT02164864|141718583|OTHER||Hazard Ratio (HR)|1.03||||0.8903|TWO_SIDED|95.0|0.71|1.47||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.47|0.71|0.8903
71106021|NCT02164864|141718584|NON_INFERIORITY|All non-inferiority tests were based on a margin of 1.38.|Hazard Ratio (HR)|1.17||||0.1128|TWO_SIDED|95.0|0.9|1.53||P values for noninferiority were calculated at a one-sided alpha level of 0.025|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|The upper bound of the Wald confidence interval (CI) of the HR of All Dabigatran Etexilate (110mg and 150 mg) vs Warfarin (one-sided 97.5%) was compared with this noninferiority margin for the testing of non-inferiority|A pre-defined hierarchical testing approach was used. This was the fifth step in hierarchy.||1.53|0.90|0.1128
71106022|NCT02164864|141718584|OTHER||Hazard Ratio (HR)|1.3||||0.072|TWO_SIDED|95.0|0.98|1.73||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.73|0.98|0.0720
71106023|NCT02164864|141718584|OTHER||Hazard Ratio (HR)|0.97||||0.875|TWO_SIDED|95.0|0.68|1.39||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.39|0.68|0.8750
70851270|NCT00669409|141190534|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-28.4|4.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.5|-28.4|
71052477|NCT03118570|141609402|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.037||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.037
71052478|NCT03118570|141609402|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.342||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.342
71052479|NCT03118570|141609402|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.515||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.515
71052480|NCT03118570|141609402|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.786||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.786
71052481|NCT03118570|141609402|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.212||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.212
70932231|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|9.3|STANDARD_ERROR_OF_MEAN|5.56|||TWO_SIDED|95.0|-1.6|20.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 20||20.3|-1.6|
70932232|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|5.58|||TWO_SIDED|95.0|-3.4|18.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20||18.5|-3.4|
70932233|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|5.68|||TWO_SIDED|95.0|-14.7|7.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 24||7.6|-14.7|
70932234|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|5.92|||TWO_SIDED|95.0|-17.9|5.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||5.3|-17.9|
71019529|NCT03372369|141546529|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the accuracy of perceived pregnancy risk score for the CDC poster between baseline and followup is 0.||||>0.01
71019530|NCT03372369|141546529|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the accuracy of perceived pregnancy risk score for the patient-centered poster between baseline and followup is 0.||||>0.01
71019531|NCT03372369|141546529|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the patient-centered poster does not produce a larger increase in the accuracy of perceived pregnancy risk score between baseline and followup than the CDC poster.||||>0.01
71019532|NCT02239601|141546530|OTHER||Odds Ratio (OR)|0.41||||0.053|TWO_SIDED|95.0|0.17|1.01|||Mixed Models Analysis|||||1.01|0.17|0.053
71052482|NCT03118570|141609402|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.655||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.655
71052483|NCT03970837|141609405|SUPERIORITY||Odds Ratio (OR)|2.57|||<|0.0001|TWO_SIDED|95.0|1.87|3.53|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 90mg dose of GSK3196165 and placebo in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 90mg dose of GSK3196165 differs from placebo in the proportion of participants achieving ACR20 response at Week 12.||3.53|1.87|<0.0001
70932235|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|5.51|||TWO_SIDED|95.0|-8.8|12.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 28||12.9|-8.8|
70932236|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|5.73|||TWO_SIDED|95.0|-8.7|13.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28||13.8|-8.7|
70932237|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|5.73|||TWO_SIDED|95.0|-8.4|14.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 32||14.1|-8.4|
70932238|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|5.92|||TWO_SIDED|95.0|-11.7|11.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32||11.5|-11.7|
71019533|NCT04682639|141546537|OTHER||LS mean difference|-18.54||||0.0103|TWO_SIDED|95.0|-32.6|-4.49|||ANCOVA||Estimates were from ANCOVA model for rank score of percent change from baseline in esophageal PEC.|||-4.49|-32.60|0.0103
71019534|NCT04682639|141546537|OTHER||LS mean difference|-7.53||||0.2861|TWO_SIDED|95.0|-21.48|6.42|||ANCOVA||Estimates were from ANCOVA model for rank score of percent change from baseline in esophageal PEC.|||6.42|-21.48|0.2861
71019535|NCT04682639|141546538|OTHER||LS mean difference|2.38||||0.4894|TWO_SIDED|95.0|-4.43|9.19|||Linear mixed effects model|||||9.19|-4.43|0.4894
71019536|NCT04682639|141546538|OTHER||LS mean difference|4.7||||0.1671|TWO_SIDED|95.0|-2.0|11.41|||Linear mixed effects model|||||11.41|-2.00|0.1671
71019537|NCT04682639|141546539|OTHER||LS mean difference|-54.53||||0.0565|TWO_SIDED|95.0|-110.59|1.54|||ANCOVA|||||1.54|-110.59|0.0565
71019538|NCT04682639|141546539|OTHER||LS mean difference|-13.95||||0.6193|TWO_SIDED|95.0|-69.61|41.71|||ANCOVA|||||41.71|-69.61|0.6193
71019539|NCT04682639|141546540|OTHER||Adjusted difference from placebo|21.9||||0.0007|TWO_SIDED|95.0|9.23|34.57|||Mantel Haenszel|||||34.57|9.23|0.0007
71019540|NCT04682639|141546540|OTHER||Adjusted difference from placebo|13.85||||0.0121|TWO_SIDED|95.0|3.03|24.66|||Mantel Haenszel|||||24.66|3.03|0.0121
71019541|NCT04682639|141546541|OTHER||Adjusted difference from placebo|12.15||||0.0173|TWO_SIDED|95.0|2.15|22.16|||Mantel Haenszel|||||22.16|2.15|0.0173
71019542|NCT04682639|141546541|OTHER||Adjusted difference from placebo|8.37||||0.059|TWO_SIDED|95.0|-0.32|17.07|||Mantel Haenszel|||||17.07|-0.32|0.0590
71106024|NCT02164864|141718585|OTHER||Hazard Ratio (HR)|1.09||||0.608|TWO_SIDED|95.0|0.79|1.51||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.51|0.79|0.6080
71106025|NCT02164864|141718585|OTHER||Hazard Ratio (HR)|0.96||||0.8348|TWO_SIDED|95.0|0.65|1.41||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.41|0.65|0.8348
71106026|NCT02164864|141718586|NON_INFERIORITY|All non-inferiority tests were based on a margin of 1.38.|Hazard Ratio (HR)|1.04||||0.0047|TWO_SIDED|95.0|0.84|1.29||P values for noninferiority were calculated at a one-sided alpha level of 0.025|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|The upper bound of the Wald confidence interval (CI) of the HR of All Dabigatran Etexilate (110mg and 150 mg) vs Warfarin (one-sided 97.5%) was compared with this noninferiority margin for the testing of non-inferiority|A pre-defined hierarchical testing approach was used. This was the third step in hierarchy.||1.29|0.84|0.0047
71106027|NCT02164864|141718586|OTHER||Hazard Ratio (HR)|1.13||||0.3002|TWO_SIDED|95.0|0.9|1.43||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.43|0.90|0.3002
70932239|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-8.8|13.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 36||13.6|-8.8|
70932240|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|5.89|||TWO_SIDED|95.0|-12.2|10.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36||10.9|-12.2|
70932241|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|5.71|||TWO_SIDED|95.0|-10.7|11.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 40||11.7|-10.7|
71106028|NCT02164864|141718586|OTHER||Hazard Ratio (HR)|0.89||||0.4432|TWO_SIDED|95.0|0.67|1.19||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.19|0.67|0.4432
71106029|NCT04358406|141718589|SUPERIORITY||||||>|0.05|||||||Cochran-Mantel-Haenszel|||||||>0.05
70932242|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|5.83|||TWO_SIDED|95.0|-15.0|7.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40||7.8|-15.0|
70932243|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|4.9|STANDARD_ERROR_OF_MEAN|5.62|||TWO_SIDED|95.0|-6.1|15.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 44||15.9|-6.1|
70932244|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|5.87|||TWO_SIDED|95.0|-10.0|13.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44||13.1|-10.0|
70932245|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|5.76|||TWO_SIDED|95.0|-10.5|12.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 48||12.1|-10.5|
70932246|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|5.93|||TWO_SIDED|95.0|-12.2|11.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||11.1|-12.2|
70932247|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|5.77|||TWO_SIDED|95.0|-9.5|13.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 52||13.2|-9.5|
70932248|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|6.04|||TWO_SIDED|95.0|-10.6|13.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52||13.1|-10.6|
71019543|NCT03870737|141546545|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Time: F = 24.81, df = 1/40.||Outcomes fitted via a mixed effects model with time as predictor.||||<.0001
71106030|NCT04358406|141718589|SUPERIORITY||||||>|0.1|||||||Chi-squared|||||||>0.1
71106031|NCT01668004|141718603|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|||Treatment comparison of uveitis occurrence rate assessed 1 year before initial anti-TNF/GLM treatment and 1 year after start of GLM treatment. Number of subjects included in analysis: N=93.||||1.0000
71106032|NCT01668004|141718604|SUPERIORITY_OR_OTHER||Treatment Ratio|4.5|||<|0.0001|TWO_SIDED|95.0|3.86|5.25|||Generalized estimating equation|||Treatment difference (expressed as ratio) in uveitis incidence rate assessed 1 year before initial anti-TNF/GLM treatment and 1 year after start of GLM treatment. Number of subjects included in analysis: N=92.||5.25|3.86|<0.0001
71106033|NCT02448381|141718620|SUPERIORITY|||||||0.04|||||||Regression, Logistic|||||||0.04
71019544|NCT03870737|141546547|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|Time: F = 5.78, df = 1/39.||Outcome was fitted using a mixed model with time as predictor.||||.02
71019545|NCT03870737|141546548|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|Time: F = 14.28, df = 1/39.||Outcome was fitted using a mixed model with time as predictor.||||.0005
71019546|NCT03870737|141546549|SUPERIORITY|||||||0.67|||||||Mixed Models Analysis|Time: F = .19, df = 1/39.||Outcome was fitted using a mixed model with time as predictor.||||.67
71019547|NCT03870737|141546550|SUPERIORITY|||||||0.76|||||||Mixed Models Analysis|Time: F = .08, df = 1/39.||Outcome was fitted using a mixed model with time as predictor.||||.76
71019548|NCT03870737|141546551|SUPERIORITY|||||||0.8|||||||Mixed Models Analysis|Time: F = .06, df = 1/39.||Outcome was fitted using a mixed model with time as predictor.||||.80
71019549|NCT02320838|141546570|OTHER||||||<|0.001||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||<0.001
71052484|NCT03970837|141609405|SUPERIORITY||Odds Ratio (OR)|2.55|||<|0.0001|TWO_SIDED|95.0|1.85|3.5|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 150mg dose of GSK3196165 and placebo in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 150mg dose of GSK3196165 differs from placebo in the proportion of participants achieving ACR20 response at Week 12.||3.50|1.85|<0.0001
71052485|NCT03970837|141609405|SUPERIORITY||Odds Ratio (OR)|5.38|||<|0.0001|TWO_SIDED|95.0|3.66|7.9|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 05mg dose of Tofacitinib and placebo in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 05mg dose of Tofacitinib differs from placebo in the proportion of participants achieving ACR20 response at Week 12.||7.90|3.66|<0.0001
71052486|NCT03970837|141609405|SUPERIORITY||Odds Ratio (OR)|0.48|||<|0.0001|TWO_SIDED|95.0|0.34|0.66|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 90 mg dose of GSK3196165 and 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 90 mg dose of GSK3196165 differs from 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12.||0.66|0.34|<0.0001
71106034|NCT02448381|141718621|SUPERIORITY||||||<|0.0001|||||||Regression, Logistic|||||||<0.0001
71019550|NCT02320838|141546571|OTHER|||||||0.04||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.04
71019551|NCT02320838|141546572|OTHER|||||||0.9||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.9
71019552|NCT02320838|141546573|OTHER|||||||0.001||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.001
71019553|NCT02320838|141546574|OTHER|||||||0.003||||||A priori threshold for statistical significance. p\<0.05|t-test, 2 sided|||||||0.003
71019554|NCT02320838|141546575|OTHER|||||||0.023||||||A priori threshold for statistical significance. p\<0.05|Chi-squared|||||||0.023
71019555|NCT02320838|141546576|OTHER|||||||0.003||||||A priori threshold for statistical significance. p\<0,05|t-test, 2 sided|||||||0.003
71019556|NCT02320838|141546577|OTHER|||||||0.8||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.8
71019557|NCT02320838|141546578|OTHER|||||||0.02||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.02
71019558|NCT02320838|141546579|OTHER|||||||0.4||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.4
71019559|NCT02320838|141546580|OTHER|||||||0.8|||||||ANOVA|||||||0.8
71019560|NCT02320838|141546581|OTHER|||||||1||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||1.0
71019561|NCT02320838|141546582|OTHER|||||||0.4||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.4
71019562|NCT02320838|141546583|OTHER|||||||0.1||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.1
71019563|NCT02320838|141546584|OTHER|||||||0.9||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.9
71019564|NCT02320838|141546585|OTHER|||||||0.9||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.9
71019565|NCT02320838|141546586|OTHER|||||||0.5||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.5
71019566|NCT02320838|141546587|OTHER|||||||0.6||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.6
71019567|NCT02320838|141546588|OTHER|||||||0.1||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.1
71019568|NCT02320838|141546589|OTHER|||||||0.2||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.2
71019569|NCT02320838|141546590|OTHER|||||||1||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||1.0
71019570|NCT03964220|141546611|OTHER||Hazard Ratio (HR)|0.65||||0.044|TWO_SIDED|95.0|0.427|0.99|||Regression, Cox|||The time to first exacerbation was analysis using Cox Proportional Hazards model with group status as the only independent variable assessing the risk of exacerbation across Tio and NonTio groups.||0.990|0.427|0.044
71019571|NCT03964220|141546612|OTHER||||||<|0.0001|||||||Negative binomial regression|||Analysis for the rate of exacerbation between Tio and NonTio groups within 6 months of follow-up.||||< 0.0001
71019572|NCT03964220|141546612|OTHER||||||<|0.0001|||||||Negative binomial regression|||Analysis for the rate of exacerbation between Tio and NonTio groups within 1 year of follow-up.||||< 0.0001
71019573|NCT00589693|141546630|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority will be established if the lower limit of the 2-sided 95% Confidence Interval (CI) of the difference in clinical cure rate (doripenem minus imipenem-cilastatin) is greater than 15%|Difference of 2 binomial proportions|-11.2|||||TWO_SIDED|95.0|-26.3|3.8|||Normal approximation of 2 proportions|||Null Hypothesis: The clinical cure rate of doripenem assessed at the EOT visit is more than 15% inferior to that of imipenem-cilastatin||3.8|-26.3|
71019574|NCT00589693|141546631|SUPERIORITY_OR_OTHER||Difference of 2 binomial proportions|-18.8|||||TWO_SIDED|95.0|-57.2|19.5|||Normal approximation of 2 proportions|||||19.5|-57.2|
71106035|NCT02448381|141718622|SUPERIORITY|||||||0.046|||||||McNemar|||||||0.046
71106036|NCT02448381|141718623|SUPERIORITY||||||=|0.0009|||||||Fisher Exact|||||||=0.0009
71106037|NCT02448381|141718624|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
70932249|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|5.87|||TWO_SIDED|95.0|-10.6|12.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 56||12.4|-10.6|
71019575|NCT00589693|141546632|SUPERIORITY_OR_OTHER||Difference of 2 binomial proportions|-5.6|||||TWO_SIDED|95.0|-23.0|11.7|||Normal approximation of 2 proportions|||||11.7|-23.0|
71019576|NCT00589693|141546633|SUPERIORITY_OR_OTHER|||||||0.14|||||||Fisher Exact|||||||0.14
71019577|NCT00589693|141546634|SUPERIORITY_OR_OTHER||Difference of 2 binomial proportions|6.7|||||TWO_SIDED|95.0|-5.0|18.5|||Normal approximation of 2 proportions|||||18.5|-5.0|
71019578|NCT01682512|141546635|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence for the change in DAS28 (ESR) was evaluated based on the two-sided 90% Confidence Interval (CI) for the treatment difference with respect to the mean change in the DAS28(ESR) score compared to baseline. Null hypothesis of non-equivalence was to be rejected if the 90% CI is fully contained within the interval of \[-0.5, 0.5\].|Adjusted mean difference|-0.4|||||TWO_SIDED|90.0|-0.83|-0.03||Model analyzed was: DAS28(ESR) change from Baseline at Week 24 = overall mean + treatment + DAS28(ESR) Baseline score + visit + visit by treatment interaction + baseline-by-visit interaction + random error.|Mixed Models Analysis|A restricted maximum likelihood (REML)-based Mixed-Effect Model Repeated Measure (MMRM) approach was used.|Adjusted mean difference was calculated as: BI 695500 - Rituxan®|||-0.03|-0.83|
71019579|NCT01682512|141546636|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|102.35|STANDARD_ERROR_OF_MEAN|107.7|||TWO_SIDED|90.0|90.5|115.76|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-tz)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error|The similarity of AUC(o- tz) was compared between treatment groups BI 695500 and Rituxan.||115.76|90.50|
71019580|NCT01682512|141546636|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|88.21|STANDARD_ERROR_OF_MEAN|107.5|||TWO_SIDED|90.0|78.24|99.46|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-tz)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error|The similarity of AUC(o- tz) was compared between treatment groups BI 695500 and MabThera.||99.46|78.24|
71019581|NCT01682512|141546636|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|86.18|STANDARD_ERROR_OF_MEAN|107.449|||TWO_SIDED|90.0|76.5|97.09|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-tz)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error|The similarity of AUC(o- tz) was compared between treatment groups Rituxan and MabThera.||97.09|76.50|
71019582|NCT01682512|141546637|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|102.46|STANDARD_ERROR_OF_MEAN|107.939|||TWO_SIDED|90.0|90.26|116.3|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf pred)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error|The similarity of AUC(o-inf pred) was compared between treatment groups BI 695500 and Rituxan.||116.30|90.26|
71052487|NCT03970837|141609405|SUPERIORITY||Odds Ratio (OR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.34|0.66|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 150mg dose of GSK3196165 and 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 150mg dose of GSK3196165 differs from 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12.||0.66|0.34|<0.0001
71052488|NCT03970837|141609409|NON_INFERIORITY|Non-inferiority over tofacitinib on ACR20 was concluded if the lower limit of the multiplicity corrected 95% Confidence Interval (CI) in the difference in proportions (GSK3196165 minus tofacitinib) was greater than -12%|Difference in Percentage|-14.7|||||TWO_SIDED|95.0|-21.3|-8.1|||Regression, Logistic|Difference in proportion and 95% CI are generated from logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||||-8.1|-21.3|
71052489|NCT03970837|141609409|NON_INFERIORITY|Non-inferiority over tofacitinib on ACR20 was concluded if the lower limit of the multiplicity corrected 95% Confidence Interval (CI) in the difference in proportions (GSK3196165 minus tofacitinib) was greater than -12%|Difference in Percentage|-17.2|||||TWO_SIDED|95.0|-23.9|-10.6|||Regression, Logistic|Difference in proportion and 95% CI are generated from logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||||-10.6|-23.9|
71106038|NCT02735200|141718627|SUPERIORITY||Mean Difference (Final Values)|1.67||||0.9|TWO_SIDED|||||the p value correspond to the pretreatment time frame.|t-test, 2 sided|||||||0.9
71106039|NCT02735200|141718627|SUPERIORITY||Mean Difference (Final Values)|26.66|||<|0.001|TWO_SIDED|||||p value corresponds to the post treatment time frame.|t-test, 2 sided|||||||<0.001
71106040|NCT01164007|141718646|SUPERIORITY_OR_OTHER|||||||0.071|||||||One-sample exact binomial test|||The observed percentage of participants with CR or PR was compared with the expected proportion under the null hypothesis (0.10) and analyzed for statistical significance using a one-sample exact binomial test.||||0.071
71106041|NCT01816295|141718662|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71019583|NCT01682512|141546637|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|86.0|STANDARD_ERROR_OF_MEAN|107.404|||TWO_SIDED|90.0|76.38|96.82|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf pred)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error|The similarity of AUC(o-inf pred) was compared between treatment groups BI 695500 and MabThera.||96.82|76.38|
71019584|NCT01682512|141546637|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|83.93|STANDARD_ERROR_OF_MEAN|107.386|||TWO_SIDED|90.0|74.57|94.47|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf pred)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error|The similarity of AUC(o-inf pred) was compared between treatment groups Rituxan and MabThera.||94.47|74.57|
71019585|NCT01682512|141546638|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|95.87|STANDARD_ERROR_OF_MEAN|106.608|||TWO_SIDED|90.0|86.21|106.62|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-336)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error|The similarity of AUC(0-336) was compared between treatment groups BI 695500 and Rituxan.||106.62|86.21|
71019586|NCT01682512|141546638|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|89.46|STANDARD_ERROR_OF_MEAN|106.775|||TWO_SIDED|90.0|80.23|99.74|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-336)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error|The similarity of AUC(0-336) was compared between treatment groups BI 695500 and MabThera.||99.74|80.23|
71019587|NCT01682512|141546638|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|93.31|STANDARD_ERROR_OF_MEAN|105.7|||TWO_SIDED|90.0|85.11|102.29|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-336)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error|The similarity of AUC(0-336) was compared between treatment groups Rituxan and MabThera.||102.29|85.11|
71019588|NCT01682512|141546639|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|93.97|STANDARD_ERROR_OF_MEAN|105.995|||TWO_SIDED|90.0|85.32|103.5|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(Cmax)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error|The similarity of observed Cmax was compared between treatment groups BI 695500 and Rituxan.||103.50|85.32|
71019589|NCT01682512|141546639|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|89.3|STANDARD_ERROR_OF_MEAN|105.657|||TWO_SIDED|90.0|81.51|97.83|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(Cmax)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error|The similarity of observed Cmax was compared between treatment groups BI 695500 and MabThera.||97.83|81.51|
71019590|NCT01682512|141546639|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|95.02|STANDARD_ERROR_OF_MEAN|105.744|||TWO_SIDED|90.0|86.62|104.25|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(Cmax)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error|The similarity of observed Cmax was compared between treatment groups Rituxan and MabThera.||104.25|86.62|
71019591|NCT01682512|141546641|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|104.49|STANDARD_ERROR_OF_MEAN|108.044|||TWO_SIDED|90.0|91.92|118.78|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf, ppk)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error|The similarity of AUC(0-inf, ppk) was compared between treatment groups BI 695500 and Rituxan.||118.78|91.92|
71019592|NCT01682512|141546641|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|91.39|STANDARD_ERROR_OF_MEAN|107.253|||TWO_SIDED|90.0|81.38|102.64|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf, ppk)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error|The similarity of AUC(0-inf, ppk) was compared between treatment groups BI 695500 and MabThera.||102.64|81.38|
71019593|NCT01682512|141546641|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|87.47|STANDARD_ERROR_OF_MEAN|107.896|||TWO_SIDED|90.0|77.12|99.21|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf, ppk)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error|The similarity of AUC(0-inf, ppk) was compared between treatment groups Rituxan and MabThera.||99.21|77.12|
71019594|NCT00054275|141546642|SUPERIORITY_OR_OTHER||proportion of pts with partial response|0.39||||0.95|TWO_SIDED|95.0|0.23|0.58|||confidence interval for partial response|Confidence interval for partial response rate using Wilson's Method||||0.58|0.23|0.95
71019595|NCT02572427|141546662|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|TWO_SIDED||||||t-test, 2 sided|||||||0.039
71106042|NCT01816295|141718663|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.1|STANDARD_ERROR_OF_MEAN|1.42|<|0.001|TWO_SIDED|99.5|1.05|9.07|||ANCOVA|||||9.07|1.05|<0.001
71019596|NCT02572427|141546663|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
71106043|NCT01816295|141718664|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9|STANDARD_ERROR_OF_MEAN|1.25||0.019|TWO_SIDED|99.5|-0.59|6.45|||ANCOVA|||||6.45|-0.59|0.019
71106044|NCT01816295|141718665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.34||0.442|TWO_SIDED|95.0|-0.94|0.41|||ANCOVA|||Change from Baseline to Week 12||0.41|-0.94|0.442
71019597|NCT04333199|141546664|SUPERIORITY||Odds Ratio (OR)|2.9903891|||<|0.001|TWO_SIDED|95.0|2.2805876|3.9211066||We used an a priori threshold of p \< .05.|Regression, Logistic|||||3.9211066|2.2805876|<0.001
71019598|NCT04333199|141546665|SUPERIORITY||Odds Ratio (OR)|1.1781659||||0.154|TWO_SIDED|95.0|0.9404654|1.4759445||We used an a priori threshold of p \< .05.|Regression, Logistic|||||1.4759445|0.9404654|0.154
71019599|NCT04333199|141546666|SUPERIORITY||Odds Ratio (OR)|0.9575636||||0.571|TWO_SIDED|95.0|0.8242111|1.1124918||We used an a priori threshold of p \< .05.|Regression, Logistic|||||1.1124918|0.8242111|0.571
71019600|NCT04333199|141546667|SUPERIORITY||Odds Ratio (OR)|1.8562672|||<|0.001|TWO_SIDED|95.0|1.5692523|2.1957769||We used an a priori threshold of p \< .05.|Regression, Logistic|||||2.1957769|1.5692523|<0.001
71019601|NCT04333199|141546669|SUPERIORITY||Odds Ratio (OR)|1.8542767|||<|0.001|TWO_SIDED|95.0|1.5220654|2.2589975||We used an a priori threshold of p \< .05.|Regression, Logistic|||||2.2589975|1.5220654|<0.001
71019602|NCT01032330|141546803|SUPERIORITY||Risk Difference (RD)|0.054||||0.004|ONE_SIDED|95.0|0.02||||One-sided Barnard's Test||||||0.020|0.004
71106045|NCT01816295|141718665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.39||0.905|TWO_SIDED|95.0|-0.82|0.72|||ANCOVA|||Change from Baseline to Week 36||0.72|-0.82|0.905
71019603|NCT01032330|141546804|OTHER||cumulative probability|0.15|||||TWO_SIDED|95.0|0.1|0.22|||||Kaplan-Meier estimate of cumulative probability of deterioration by 3 years|||.22|.10|
71019604|NCT01032330|141546805|SUPERIORITY||Risk Difference (RD)|0.024||||0.27|TWO_SIDED|95.0|-0.038|0.094|||One-sided Barnard's Test|||||0.094|-0.038|0.27
71019605|NCT01032330|141546807|OTHER||||||<|0.001|||||||ANCOVA|||P-value for the change between baseline and 3 years. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||<.001
71019606|NCT01032330|141546808|OTHER|||||||0.38|||||||ANCOVA|||Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome; P values for comparisons of binary outcomes are from logistic regression models adjusting for the baseline level of the outcome.||||0.38
71019607|NCT01032330|141546809|OTHER||||||<|0.001|||||||ANCOVA|||P-value for the change between baseline and 3 years. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||<.001
70932250|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|6.08|||TWO_SIDED|95.0|-10.4|13.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56||13.5|-10.4|
70932251|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|5.89|||TWO_SIDED|95.0|-11.9|11.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 60||11.2|-11.9|
71052490|NCT04874636|141609619|SUPERIORITY||Posterior Mean Difference|0.08|||||TWO_SIDED|95.0|-0.59|0.75|||||Posterior mean difference with 95% credible interval is reported.|||0.75|-0.59|
71052491|NCT04874636|141609620|SUPERIORITY||Posterior Mean Difference|0.49|||||TWO_SIDED|95.0|-1.02|2.0|||||Posterior mean difference with 95% credible interval is reported.|||2.00|-1.02|
71052492|NCT04874636|141609621|SUPERIORITY||Posterior Mean Difference|0.14|||||TWO_SIDED|95.0|-0.27|0.55|||||Posterior mean difference with 95% credible interval is reported.|||0.55|-0.27|
71052493|NCT04874636|141609622|SUPERIORITY||Posterior Mean Difference|0.29|||||TWO_SIDED|95.0|-0.43|1.02|||||Posterior mean difference with 95% credible interval is reported.|||1.02|-0.43|
71052494|NCT04874636|141609623|SUPERIORITY||Posterior Mean Difference|7.9|||||TWO_SIDED|95.0|-0.32|16.14|||||Posterior mean difference with 95% credible interval is reported.|||16.14|-0.32|
71052495|NCT04874636|141609624|SUPERIORITY||Posterior Mean Difference|-0.17|||||TWO_SIDED|95.0|-0.65|0.3|||||Posterior mean difference with 95% credible interval is reported.|||0.30|-0.65|
71052496|NCT04874636|141609625|SUPERIORITY||Posterior Mean Difference|-34.98|||||TWO_SIDED|95.0|-176.34|106.69|||||Posterior mean difference with 95% credible interval is reported.|||106.69|-176.34|
71052497|NCT04874636|141609626|SUPERIORITY||Posterior Mean Difference|0.0|||||TWO_SIDED|95.0|-0.1|0.09|||||Posterior mean difference with 95% credible interval is reported.|||0.09|-0.10|
71052498|NCT00786994|141609645|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Mantel Haenszel|||A vs C/D||||0.60
71052499|NCT00786994|141609645|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Mantel Haenszel|||B vs. C/D||||0.83
71106046|NCT01259011|141718697|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9|||<|0.05|TWO_SIDED|95.0|1.1|3.3|||Mixed Models Analysis|||||3.3|1.1|<.05
70932252|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|6.17|||TWO_SIDED|95.0|-9.7|14.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60||14.6|-9.7|
70932253|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|5.87|||TWO_SIDED|95.0|-11.7|11.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 64||11.3|-11.7|
70932254|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|6.09|||TWO_SIDED|95.0|-12.2|11.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64||11.7|-12.2|
70932255|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|2.3|STANDARD_ERROR_OF_MEAN|5.91|||TWO_SIDED|95.0|-9.3|13.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 68||13.9|-9.3|
70932256|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|6.08|||TWO_SIDED|95.0|-9.8|14.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68||14.0|-9.8|
71052500|NCT02213510|141609665|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71052501|NCT02213510|141609666|SUPERIORITY_OR_OTHER|||||||0.655|TWO_SIDED||||||t-test, 2 sided|||||||0.655
71052502|NCT02213510|141609667|SUPERIORITY_OR_OTHER|||||||0.811|TWO_SIDED||||||t-test, 2 sided|||||||0.811
71106047|NCT01259011|141718698|SUPERIORITY||Slope|-1.2||||0.12|TWO_SIDED|95.0|-2.8|0.3||HADS-anxiety|Regression, Linear|||||0.3|-2.8|0.12
71106048|NCT01259011|141718698|SUPERIORITY||Slope|-2.2|||<|0.05|TWO_SIDED|95.0|-4.2|-0.3||HADS-depression|Regression, Linear|||||-0.3|-4.2|<0.05
71052503|NCT02213510|141609668|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||t-test, 2 sided|||||||1.00
71052504|NCT02213510|141609669|SUPERIORITY_OR_OTHER|||||||0.462|TWO_SIDED||||||t-test, 2 sided|||||||0.462
71052505|NCT02213510|141609670|SUPERIORITY_OR_OTHER|||||||0.646|TWO_SIDED||||||t-test, 2 sided|||||||0.646
71052506|NCT02213510|141609671|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||t-test, 2 sided|||||||0.510
71052507|NCT02213510|141609672|SUPERIORITY_OR_OTHER|||||||0.651|TWO_SIDED||||||t-test, 2 sided|||||||0.651
71052508|NCT02213510|141609673|SUPERIORITY_OR_OTHER|||||||0.588|TWO_SIDED||||||t-test, 2 sided|||||||0.588
71052509|NCT02213510|141609674|SUPERIORITY_OR_OTHER|||||||0.858|TWO_SIDED||||||t-test, 2 sided|||||||0.858
71052510|NCT02213510|141609675|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||t-test, 2 sided|||||||1.00
71052511|NCT05958888|141609683|SUPERIORITY||Mean Difference (Final Values)|0.99|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||<0.001
71052512|NCT05958888|141609683|SUPERIORITY||Mean Difference (Final Values)|1.39|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome.The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||<0.001
71106049|NCT01259011|141718699|SUPERIORITY||Slope|-4.0||||0.21|TWO_SIDED|95.0|-10.2|2.2|||Regression, Linear|||||2.2|-10.2|0.21
71106050|NCT03510273|141718715|OTHER|"Type of statistical test: Independence~Description: Adequacy of baseline image"||||||0.396|||||||Fisher Exact|||||||0.396
71106051|NCT03510273|141718715|OTHER|"Type of statistical test: Independence~Description: Squamous columnar junction visibility"||||||0.351|||||||Fisher Exact|||||||0.351
70932257|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|5.91|||TWO_SIDED|95.0|-14.5|8.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 72||8.7|-14.5|
70932258|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|6.06|||TWO_SIDED|95.0|-13.7|10.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||10.1|-13.7|
70932259|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|6.05|||TWO_SIDED|95.0|-10.0|13.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 76||13.7|-10.0|
70932260|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|6.13|||TWO_SIDED|95.0|-12.2|11.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76||11.8|-12.2|
71019608|NCT01032330|141546810|OTHER|||||||0.09|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.09
71019609|NCT01032330|141546810|OTHER|||||||0.02|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.02
71019610|NCT01032330|141546811|OTHER||||||<|0.001|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||<.001
71019611|NCT01032330|141546811|OTHER|||||||0.33|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.33
71019612|NCT01032330|141546812|OTHER|||||||0.013|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.013
71019613|NCT01032330|141546812|OTHER|||||||0.26|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.26
71019614|NCT01032330|141546813|OTHER|||||||0.42|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.42
71019615|NCT01032330|141546813|OTHER|||||||0.61|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.61
71019616|NCT01032330|141546814|OTHER|||||||0.012|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.012
71019617|NCT01032330|141546814|OTHER|||||||0.02|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.02
71019618|NCT01032330|141546815|OTHER|||||||0.002|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||.002
71019619|NCT01032330|141546815|OTHER|||||||0.01|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.01
71019620|NCT01032330|141546816|OTHER|||||||0.11|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.11
71019621|NCT01032330|141546816|OTHER|||||||0.1|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.10
71019622|NCT01032330|141546817|OTHER|||||||0.6|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.60
71019623|NCT01032330|141546817|OTHER|||||||0.09|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.09
71019624|NCT01155284|141546818|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED|||||The p value between treatment groups of C-peptide log (AUC+1) with covariate analysis adjusted for age, sex, baseline C-peptide concentration and duration of diabetes.|ANCOVA|||||||0.81
71019625|NCT01155284|141546819|SUPERIORITY_OR_OTHER|||||||0.869|TWO_SIDED||||||ANCOVA|||||||0.869
71019626|NCT01766310|141546820|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.68|STANDARD_DEVIATION|1.3||0.05|TWO_SIDED|95.0|-0.09|1.44|||t-test, 2 sided|||||1.44|-0.09|0.05
71019627|NCT01556490|141546830|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.4552|TWO_SIDED|95.0|0.89|1.31|||Log Rank|||||1.31|0.89|0.4552
71019628|NCT01556490|141546831|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0626|TWO_SIDED|95.0|0.61|1.01|||Log Rank|||||1.01|0.61|0.0626
71019629|NCT01556490|141546832|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0227|TWO_SIDED|95.0|0.59|0.96|||Log Rank|||||.96|.59|0.0227
71019630|NCT01556490|141546833|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0043|TWO_SIDED|95.0|0.52|0.89|||Log Rank|||||.89|.52|0.0043
70932261|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|6.05|||TWO_SIDED|95.0|-9.1|14.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 80||14.7|-9.1|
70932262|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|6.01|||TWO_SIDED|95.0|-11.3|12.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80||12.3|-11.3|
70932263|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|5.95|||TWO_SIDED|95.0|-11.9|11.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 84||11.5|-11.9|
70932264|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|6.04|||TWO_SIDED|95.0|-12.0|11.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84||11.7|-12.0|
70932265|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|5.86|||TWO_SIDED|95.0|-13.2|9.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 88||9.8|-13.2|
71019631|NCT01556490|141546834|SUPERIORITY||Mean Difference (Final Values)|15.5||||0.0001|TWO_SIDED|95.0|8.6|22.3|||2 sided calculated using continuity|2 sided calculated using continuity adjusted Wald Approach||||22.3|8.6|0.0001
71019632|NCT02328404|141546836|SUPERIORITY_OR_OTHER|||||||0.001|||||||Chi-squared|Fisher Exact test was used||The participants in the treatment and placebo groups will be classified into two categories of prognosis (improved and not improved) and will be analyzed using Chi-square test, if Chi-square is higher than 3.84 (df=1) it will be statistically significant (p-value\</= 0.05)||||0.001
71019633|NCT02328404|141546837|SUPERIORITY_OR_OTHER||||||<|0||||||A P-value \< 0.05 would be considered statistically significant.|t-test, 2 sided|||Both arms where evaluated at which paired t-test for the mean difference in the two arm was calculated . where the serum 25-OH Vit D3 was measured at 0 day time and after the end of the study. after that a paired t-test where applied for the difference for the 25-OH VitD3 levels between the two time points||||<0.000
71019634|NCT02328404|141546838|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||t-test, 2 sided|||||||0.67
71019635|NCT02328404|141546839|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||t-test, 2 sided|||||||0.51
70932266|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|6.0|||TWO_SIDED|95.0|-12.6|11.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88||11.0|-12.6|
70932267|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|5.87|||TWO_SIDED|95.0|-9.8|13.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 92||13.3|-9.8|
71019636|NCT02328404|141546840|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||t-test, 2 sided|||||||0.08
71019637|NCT02328404|141546841|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||||||0.01
71019638|NCT02328404|141546842|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Chi-squared|||||||0.001
71019639|NCT02328404|141546843|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||t-test, 2 sided|||||||0.89
71052513|NCT05958888|141609683|SUPERIORITY||Mean Difference (Final Values)|1.62|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||<.001
71052514|NCT05958888|141609683|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.1|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||.10
71052515|NCT05958888|141609683|SUPERIORITY||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.2||0.01|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||.01
71019640|NCT02328404|141546844|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||t-test, 2 sided|||||||0.60
71019641|NCT02328404|141546845|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||||||0.01
71019642|NCT02328404|141546846|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||t-test, 2 sided|||||||0.35
71052516|NCT05958888|141609683|SUPERIORITY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.2||0.25|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.25
71052517|NCT05958888|141609684|SUPERIORITY||Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||<.001
71052518|NCT05958888|141609684|SUPERIORITY||Mean Difference (Final Values)|6.0|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||<.001
71052519|NCT05958888|141609684|SUPERIORITY||Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||<.001
71019643|NCT02328404|141546847|SUPERIORITY_OR_OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.65
71019644|NCT02328404|141546848|SUPERIORITY_OR_OTHER|||||||0.25|||||||t-test, 2 sided|||||||0.25
71019645|NCT02328404|141546849|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.04
71019646|NCT02328404|141546850|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.02
71019647|NCT02618772|141546851|SUPERIORITY_OR_OTHER|||||||0.026|||||||t-test, 2 sided|||||||0.026
71019648|NCT02618772|141546852|SUPERIORITY_OR_OTHER|||||||0.036|||||||t-test, 2 sided|||||||0.036
71019649|NCT02618772|141546853|SUPERIORITY_OR_OTHER|||||||0.151||||||This is in reference to the baseline measure.|t-test, 2 sided|||||||0.151
71052520|NCT05958888|141609684|SUPERIORITY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.85||0.12|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||.12
71052521|NCT05958888|141609684|SUPERIORITY||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||<.001
71106052|NCT03510273|141718715|OTHER|"Type of statistical test: Independence~Description: Visible abnormal areas"||||||0.774|||||||Fisher Exact|||||||0.774
71106053|NCT03510273|141718715|OTHER|"Type of statistical test: Independence~Description: Location of the lesion"||||||1|||||||Fisher Exact|||||||1
70932268|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|6.09|||TWO_SIDED|95.0|-11.1|12.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92||12.8|-11.1|
71019650|NCT02618772|141546853|SUPERIORITY_OR_OTHER|||||||0.02||||||This is in reference to the intervention measure.|t-test, 2 sided|||||||0.020
71019651|NCT02618772|141546853|SUPERIORITY_OR_OTHER|||||||0.198||||||This is in reference to the lidocaine measure.|t-test, 2 sided|||||||0.198
71019652|NCT02618772|141546853|SUPERIORITY_OR_OTHER|||||||0.006||||||This is in reference to the difference between the suturing and baseline measures.|t-test, 2 sided|||||||0.006
71019653|NCT02618772|141546854|SUPERIORITY_OR_OTHER|||||||0.185||||||This is in reference to the baseline measure.|t-test, 2 sided|||||||0.185
71019654|NCT02618772|141546854|SUPERIORITY_OR_OTHER|||||||0.011||||||This is in reference to the intervention measure.|t-test, 2 sided|||||||0.011
71019655|NCT02618772|141546854|SUPERIORITY_OR_OTHER|||||||0.191||||||This is in reference to the lidocaine measure.|t-test, 2 sided|||||||0.191
71019656|NCT02618772|141546854|SUPERIORITY_OR_OTHER|||||||0.008||||||This is in reference to the difference between the suturing and baseline measures.|t-test, 2 sided|||||||0.008
71019657|NCT02618772|141546855|SUPERIORITY_OR_OTHER|||||||0.004||||||This p value is a t-test of the Post STAI minus Pre STAI variable.|t-test, 2 sided|||||||0.004
71019658|NCT02618772|141546856|SUPERIORITY_OR_OTHER|||||||0.015||||||This p value is in reference to the t-test performed for STAI Post Minus STAI Pre.|t-test, 2 sided|||||||0.015
71019659|NCT02618772|141546857|SUPERIORITY_OR_OTHER|||||||0.08|||||||t-test, 2 sided|||||||0.080
71019660|NCT02618772|141546858|SUPERIORITY_OR_OTHER|||||||0.086|||||||t-test, 2 sided|||||||0.086
71019661|NCT02618772|141546859|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71019662|NCT02618772|141546860|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71019663|NCT04529499|141546868|SUPERIORITY|||||||0.67|||||||Log Rank|||||||0.67
71019664|NCT04529499|141546868|SUPERIORITY||Cox Proportional Hazard|0.991|||||TWO_SIDED|95.0|0.767|1.28|||||Favipiravir + supportive care in numerator and Placebo+ Supportive care in denominator for CPH ratio analysis|||1.280|0.767|
71019665|NCT04529499|141546869|SUPERIORITY|||||||0.34|||||||Fisher Exact|||||||0.34
71019666|NCT01039584|141546886|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The primary efficacy measure was the proportion of subjects with therapeutic cure at Visit 3/Test-of-Cure. Therapeutic cure was defined as having both a mycological cure and a clinical cure.|Yates continuity correction|1.5|||||TWO_SIDED|90.0|-9.1|12.3|||Wald's method|||||12.3|-9.1|
71019667|NCT01039584|141546887|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The efficacy measure was the proportion of subjects with clinicl cure at Visit 3/Test-of-Cure.|Yates continuity correction|1.5|||||TWO_SIDED|90.0|-7.3|12.8|||Wald's method|||||12.8|-7.3|
71019668|NCT01039584|141546888|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The efficacy measure was the proportion of subjects with mycological cure at Visit 3/Test-of-Cure|Yates continuity correction|1.5||||0.05|TWO_SIDED|90.0|-11.7|9.4|||Wald's method|||||9.4|-11.7|0.05
71019669|NCT01494649|141546889|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1||||0.2294|TWO_SIDED|95.0|-0.26|0.06||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|The model included treatment as a fixed factor and basline Schiff score as a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favoured stannous fluoride toothpaste.|Null hypothesis is no difference between treatments. Tests were 2-sided.||0.06|-0.26|0.2294
71019670|NCT01494649|141546890|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.12||||0.1792||95.0|-0.3|0.06||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment was a fixed factor and baseline Schiff Sensitivity Score was a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favored stannous fluoride toothpaste.|Null hypothesis was no difference between treatments. Tests were 2-sided.||0.06|-0.30|0.1792
71019671|NCT01494649|141546891|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.52|||<|0.0001|TWO_SIDED|95.0|-0.74|-0.3||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment was a fixed factor and baseline Schiff Sensitivity Score was a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favored stannous fluoride toothpaste.|Null hypothesis was no difference between treatments. Tests were 2-sided.||-0.30|-0.74|<0.0001
71106054|NCT03510273|141718715|OTHER|"Type of statistical test: Independence~Description: Mosaic of the worst lesion"||||||0.36|||||||Fisher Exact|||||||0.36
71019672|NCT01494649|141546892|SUPERIORITY_OR_OTHER||Mean adjusted difference|-0.08||||0.9445|TWO_SIDED|95.0|-2.49|2.32||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment was a fixed factor and baseline Tactile Threshold score was a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favored stannous fluoride toothpaste.|Null hypothesis was no difference between treatments. Tests were 2-sided.||2.32|-2.49|0.9445
71019673|NCT01494649|141546893|SUPERIORITY_OR_OTHER||Adjusted mean|-2.07||||0.22|TWO_SIDED|95.0|-5.38|1.25||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment was a fixed factor and baseline tactile threshold score was a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favored stannous fluoride toothpaste.|Null hypothesis was no difference between treatments. Tests were 2-sided.||1.25|-5.38|0.220
71019674|NCT01494649|141546894|SUPERIORITY_OR_OTHER||Mean adjusted difference|8.69||||0.0004|TWO_SIDED|95.0|3.96|13.43||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment was a fixed factor and baseline tactile threshold score was a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favored stannous fluoride toothpaste.|Null hypothesis was no difference between treatments. Tests were 2-sided.||13.43|3.96|0.0004
71019675|NCT03467971|141546895|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|175.6652|||||TWO_SIDED|90.0|153.779|200.6664||||||Statistical Analysis for Metformin||200.6664|153.7790|
71019676|NCT03467971|141546895|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|104.457|||||TWO_SIDED|90.0|97.766|111.606||||||Statistical Analysis for Gliclazide||111.6060|97.7660|
71019677|NCT03467971|141546896|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|180.7734|||||TWO_SIDED|90.0|157.0135|208.1287||||||Statistical Analysis for Metformin||208.1287|157.0135|
71019678|NCT03467971|141546896|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|105.0818|||||TWO_SIDED|90.0|98.0047|112.6699||||||Statistical Analysis for Gliclazide||112.6699|98.0047|
71019679|NCT03467971|141546897|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|127.7779|||||TWO_SIDED|90.0|110.2732|148.0612||||||Statistical Analysis for Metformin||148.0612|110.2732|
71019680|NCT03467971|141546897|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|105.4183|||||TWO_SIDED|90.0|94.5723|117.5081||||||Statistical Analysis for Gliclazide||117.5081|94.5723|
71019681|NCT01236053|141546908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.0002|TWO_SIDED|95.0|1.07|1.24|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)"|||1.24|1.07|0.0002
71019682|NCT01236053|141546908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.0976|TWO_SIDED|95.0|0.99|1.15|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.15|0.99|0.0976
71019683|NCT01236053|141546908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29|||<|0.0001|TWO_SIDED|95.0|1.23|1.36|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)"|||1.36|1.23|<0.0001
71019684|NCT01236053|141546908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19|||<|0.0001|TWO_SIDED|95.0|1.13|1.26|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.26|1.13|<0.0001
71019685|NCT01236053|141546909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.1468|TWO_SIDED|95.0|0.97|1.23|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.23|0.97|0.1468
71019686|NCT01236053|141546909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.8545|TWO_SIDED|95.0|0.9|1.14|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.14|0.90|0.8545
71019687|NCT01236053|141546909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37|||<|0.0001|TWO_SIDED|95.0|1.27|1.48|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.48|1.27|<0.0001
71019688|NCT01236053|141546909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27|||<|0.0001|TWO_SIDED|95.0|1.18|1.37|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.37|1.18|<0.0001
71019689|NCT01236053|141546909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.0033|TWO_SIDED|95.0|1.07|1.43|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.43|1.07|0.0033
71019690|NCT01236053|141546909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.0474|TWO_SIDED|95.0|1.0|1.33|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.33|1.00|0.0474
71019691|NCT01236053|141546909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29|||<|0.0001|TWO_SIDED|95.0|1.16|1.43|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.43|1.16|<0.0001
71019692|NCT01236053|141546909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.0008|TWO_SIDED|95.0|1.08|1.32|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.32|1.08|0.0008
71019693|NCT01236053|141546909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.019|TWO_SIDED|95.0|1.03|1.33|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.33|1.03|0.0190
71019694|NCT01236053|141546909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.3366|TWO_SIDED|95.0|0.94|1.21|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.21|0.94|0.3366
71052522|NCT05958888|141609684|SUPERIORITY||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.85||0.04|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.04
71052523|NCT05958888|141609685|SUPERIORITY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.19||0.01|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||.01
71052524|NCT05958888|141609685|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.19||0.23|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||.23
71019695|NCT01236053|141546909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.0001|TWO_SIDED|95.0|1.09|1.31|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.31|1.09|0.0001
71019696|NCT01236053|141546909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.0464|TWO_SIDED|95.0|1.0|1.2|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.20|1.00|0.0464
71019697|NCT01236053|141546910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.1194|TWO_SIDED|95.0|0.97|1.26|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.26|0.97|0.1194
71052525|NCT05958888|141609685|SUPERIORITY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.19||0.01|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||.01
71052526|NCT05958888|141609685|SUPERIORITY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.19||0.58|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||.58
71052527|NCT05958888|141609685|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.19||0.85|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||.85
71052528|NCT05958888|141609685|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.19||0.58|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.58
71106055|NCT03510273|141718715|OTHER|"Type of Statistical Test: Independence~Description: Acetowhite changes"||||||0.881|||||||Fisher Exact|||||||0.881
71106056|NCT03510273|141718715|OTHER|"Type of Statistical Test: Independence~Description: Border of the worst lesion"||||||0.829|||||||Fisher Exact|||||||0.829
71106057|NCT03510273|141718715|OTHER|"Type of Statistical Test: Independence~Description: Possible diagnosis"||||||1|||||||Fisher Exact|||||||1
71106058|NCT03510273|141718715|OTHER|"Type of Statistical Test: Independence~Description: Baseline histology"||||||1|||||||Fisher Exact|||||||1
71106059|NCT03510273|141718715|OTHER|"Type of Statistical Test: Independence~Description: Size of the worst lesion (% coverage)"||||||0.493|||||||Fisher Exact|||||||0.493
71019698|NCT01236053|141546910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.7004|TWO_SIDED|95.0|0.9|1.17|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.17|0.90|0.7004
71019699|NCT01236053|141546910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37|||<|0.0001|TWO_SIDED|95.0|1.26|1.49|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.49|1.26|<0.0001
71019700|NCT01236053|141546910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26|||<|0.0001|TWO_SIDED|95.0|1.16|1.38|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.38|1.16|<0.0001
71019701|NCT01236053|141546910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.0134|TWO_SIDED|95.0|1.03|1.34|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.34|1.03|0.0134
71052529|NCT05958888|141609686|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.1|>|0.99|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||>.99
71052530|NCT05958888|141609686|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.1|>|0.99|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||>.99
71019702|NCT01236053|141546910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.1592|TWO_SIDED|95.0|0.96|1.25|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.25|0.96|0.1592
71019703|NCT01236053|141546910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35|||<|0.0001|TWO_SIDED|95.0|1.24|1.47|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.47|1.24|<0.0001
71019704|NCT01236053|141546910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25|||<|0.0001|TWO_SIDED|95.0|1.14|1.36|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.36|1.14|<0.0001
71019705|NCT01236053|141546910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.0131|TWO_SIDED|95.0|1.03|1.33|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.33|1.03|0.0131
71019706|NCT01236053|141546910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.2731|TWO_SIDED|95.0|0.95|1.22|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.22|0.95|0.2731
71019707|NCT01236053|141546910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.0012|TWO_SIDED|95.0|1.06|1.28|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.28|1.06|0.0012
71019708|NCT01236053|141546910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.1477|TWO_SIDED|95.0|0.98|1.17|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.17|0.98|0.1477
71019709|NCT01236053|141546911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.0369|TWO_SIDED|95.0|1.01|1.41|||Conditional Logistic Regression||"Comparison: \> 1 year (with 2 year lag) and Never (with 2 year lag)."|||1.41|1.01|0.0369
71019710|NCT01236053|141546911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.3132|TWO_SIDED|95.0|0.92|1.29|||Conditional Logistic Regression||"Comparison: \> 1 year (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.29|0.92|0.3132
71019711|NCT01236053|141546911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.0762|TWO_SIDED|95.0|0.99|1.26|||Conditional Logistic Regression||"Comparison: \> 1 year (without 2 year lag) and Never (without 2 year lag)."|||1.26|0.99|0.0762
71019712|NCT01236053|141546911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.7243|TWO_SIDED|95.0|0.91|1.15|||Conditional Logistic Regression||"Comparison: \> 1 year (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.15|0.91|0.7243
71019713|NCT01236053|141546911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.0775|TWO_SIDED|95.0|0.97|1.65|||Conditional Logistic Regression||"Comparison: \> 2 years (with 2 year lag) and Never (with 2 year lag)."|||1.65|0.97|0.0775
71019714|NCT01236053|141546911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.2649|TWO_SIDED|95.0|0.89|1.52|||Conditional Logistic Regression||"Comparison: \> 2 years (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.52|0.89|0.2649
71019715|NCT01236053|141546911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.0257|TWO_SIDED|95.0|1.02|1.43|||Conditional Logistic Regression||"Comparison: \> 2 years (without 2 year lag) and Never (without 2 year lag)."|||1.43|1.02|0.0257
71106060|NCT01276106|141718716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.175||0.044|TWO_SIDED|95.0|-0.7|-0.01||No adjustments for multiple comparisons were made and a value of p\<0.05 was considered statistically significant.|ANCOVA|||Change from baseline in HbA1c was analyzed using an analysis of covariance model with change in HbA1c as the dependent variable, treatment as a fixed effect, and baseline HbA1c as a covariate.||-0.01|-0.70|0.044
71019716|NCT01236053|141546911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.254|TWO_SIDED|95.0|0.93|1.3|||Conditional Logistic Regression||"Comparison: \> 2 years (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.30|0.93|0.2540
71019717|NCT01236053|141546911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.5141|TWO_SIDED|95.0|0.76|1.75|||Conditional Logistic Regression||"Comparison: \> 3 years (with 2 year lag) and Never (with 2 year lag)."|||1.75|0.76|0.5141
71019718|NCT01236053|141546911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.8208|TWO_SIDED|95.0|0.69|1.6|||Conditional Logistic Regression||"Comparison: \> 3 years (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.60|0.69|0.8208
71019719|NCT01236053|141546911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.0562|TWO_SIDED|95.0|0.99|1.62|||Conditional Logistic Regression||"Comparison: \> 3 years (without 2 year lag) and Never (without 2 year lag)."|||1.62|0.99|0.0562
71019720|NCT01236053|141546911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.2596|TWO_SIDED|95.0|0.9|1.47|||Conditional Logistic Regression||"Comparison: \> 3 years (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.47|0.90|0.2596
71019721|NCT01236053|141546912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.0709|TWO_SIDED|95.0|0.99|1.28|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.28|0.99|0.0709
71019722|NCT01236053|141546912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.4996|TWO_SIDED|95.0|0.92|1.19|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.19|0.92|0.4996
71019723|NCT01236053|141546912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34|||<|0.0001|TWO_SIDED|95.0|1.23|1.45|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.45|1.23|<0.0001
71019724|NCT01236053|141546912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24|||<|0.0001|TWO_SIDED|95.0|1.14|1.35|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.35|1.14|<0.0001
71019725|NCT01236053|141546912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.0062|TWO_SIDED|95.0|1.05|1.36|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.36|1.05|0.0062
71019726|NCT01236053|141546912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.1144|TWO_SIDED|95.0|0.98|1.26|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.26|0.98|0.1144
71019727|NCT01236053|141546912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42|||<|0.0001|TWO_SIDED|95.0|1.3|1.55|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.55|1.30|<0.0001
71019728|NCT01236053|141546912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31|||<|0.0001|TWO_SIDED|95.0|1.2|1.43|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.43|1.20|<0.0001
71019729|NCT01236053|141546912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.0469|TWO_SIDED|95.0|1.0|1.29|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.29|1.00|0.0469
71019730|NCT01236053|141546912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.5169|TWO_SIDED|95.0|0.92|1.19|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.19|0.92|0.5169
71019731|NCT01236053|141546912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13||||0.0103|TWO_SIDED|95.0|1.03|1.24|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.24|1.03|0.0103
71019732|NCT01236053|141546912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.4182|TWO_SIDED|95.0|0.95|1.14|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.14|0.95|0.4182
71019733|NCT01236053|141546913|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|0.65||||0.3597|TWO_SIDED|95.0|0.26|1.62|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||1.62|0.26|0.3597
71052531|NCT05958888|141609686|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.47|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||.47
71019734|NCT01236053|141546913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.54||||0.1845|TWO_SIDED|95.0|0.21|1.34|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||1.34|0.21|0.1845
71019735|NCT01236053|141546913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.9142|TWO_SIDED|95.0|0.58|1.84|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||1.84|0.58|0.9142
71019736|NCT01236053|141546913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.6524|TWO_SIDED|95.0|0.49|1.57|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||1.57|0.49|0.6524
71019737|NCT01236053|141546914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53||||0.2875|TWO_SIDED|95.0|0.17|1.7|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.70|0.17|0.2875
71019738|NCT01236053|141546914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.2042|TWO_SIDED|95.0|0.15|1.51|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||1.51|0.15|0.2042
71019739|NCT01236053|141546914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.4733|TWO_SIDED|95.0|0.38|8.06|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||8.06|0.38|0.4733
71019740|NCT01236053|141546914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.7867|TWO_SIDED|95.0|0.26|5.85|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||5.85|0.26|0.7867
71019741|NCT01236053|141546914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.53||||0.0049|TWO_SIDED|95.0|1.47|8.5|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||8.50|1.47|0.0049
71019742|NCT01236053|141546914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.87||||0.0218|TWO_SIDED|95.0|1.17|7.08|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||7.08|1.17|0.0218
71019743|NCT01236053|141546914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.849|TWO_SIDED|95.0|0.27|2.92|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.92|0.27|0.8490
71019744|NCT01236053|141546914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.6263|TWO_SIDED|95.0|0.22|2.46|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||2.46|0.22|0.6263
71052532|NCT05958888|141609686|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.1|>|0.99|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||>.99
71052533|NCT05958888|141609686|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.1||0.45|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||.45
70932269|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|5.91|||TWO_SIDED|95.0|-15.6|7.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 96||7.6|-15.6|
70932270|NCT02307682|141364355|OTHER|Treatment difference|Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|6.07|||TWO_SIDED|95.0|-15.8|8.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||8.0|-15.8|
71019745|NCT01236053|141546914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61||||0.4122|TWO_SIDED|95.0|0.19|1.97|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.97|0.19|0.4122
71019746|NCT01236053|141546914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.51||||0.2642|TWO_SIDED|95.0|0.16|1.66|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||1.66|0.16|0.2642
71019747|NCT01236053|141546915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.7891|TWO_SIDED|95.0|0.31|2.43|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||2.43|0.31|0.7891
71019748|NCT01236053|141546915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.6216|TWO_SIDED|95.0|0.27|2.17|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||2.17|0.27|0.6216
71019749|NCT01236053|141546915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.6893|TWO_SIDED|95.0|0.31|5.96|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||5.96|0.31|0.6893
71019750|NCT01236053|141546915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.9273|TWO_SIDED|95.0|0.24|4.84|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||4.84|0.24|0.9273
71019751|NCT01236053|141546915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.598|TWO_SIDED|95.0|0.47|3.78|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.78|0.47|0.5980
71019752|NCT01236053|141546915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.8572|TWO_SIDED|95.0|0.38|3.18|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||3.18|0.38|0.8572
71019753|NCT01236053|141546915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.7807|TWO_SIDED|95.0|0.26|2.77|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.77|0.26|0.7807
71019754|NCT01236053|141546915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.5579|TWO_SIDED|95.0|0.21|2.32|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||2.32|0.21|0.5579
71019755|NCT01236053|141546915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.9932|TWO_SIDED|95.0|0.4|2.53|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.53|0.40|0.9932
71019756|NCT01236053|141546915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.6901|TWO_SIDED|95.0|0.32|2.11|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||2.11|0.32|0.6901
71019757|NCT01236053|141546917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62||||0.431|TWO_SIDED|95.0|0.19|2.01|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||2.01|0.19|0.4310
71052534|NCT05958888|141609686|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.1||0.7|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.70
71106061|NCT01276106|141718716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.176||0.0979|TWO_SIDED|95.0|-0.64|0.05||No adjustments for multiple comparisons were made and a value of p\<0.05 was considered statistically significant.|ANCOVA|||Change from baseline in HbA1c was analyzed using an analysis of covariance model with change in HbA1c as the dependent variable, treatment as a fixed effect, and baseline HbA1c as a covariate.||0.05|-0.64|0.0979
71019758|NCT01236053|141546917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55||||0.3226|TWO_SIDED|95.0|0.17|1.79|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||1.79|0.17|0.3226
71019759|NCT01236053|141546917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.6206|TWO_SIDED|95.0|0.4|4.59|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||4.59|0.40|0.6206
71052535|NCT05958888|141609687|SUPERIORITY||Mean Difference (Final Values)|0.89|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||<.001
70932271|NCT02307682|141364356|OTHER||Difference in proportions|-9.4|||||TWO_SIDED|95.0|-16.4|-3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||-3.3|-16.4|
71019760|NCT01236053|141546917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.8557|TWO_SIDED|95.0|0.33|3.84|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||3.84|0.33|0.8557
71019761|NCT01236053|141546917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.1498|TWO_SIDED|95.0|0.79|4.62|||Unadjusted Odds Ratio||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||4.62|0.79|0.1498
71019762|NCT01236053|141546917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.2645|TWO_SIDED|95.0|0.68|4.07|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||4.07|0.68|0.2645
71019763|NCT01236053|141546917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.5728|TWO_SIDED|95.0|0.16|2.79|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.79|0.16|0.5728
71019764|NCT01236053|141546917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52||||0.3727|TWO_SIDED|95.0|0.12|2.21|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||2.21|0.12|0.3727
71019765|NCT01236053|141546917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.7743|TWO_SIDED|95.0|0.31|2.4|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.40|0.31|0.7743
71106062|NCT01276106|141718716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.174||0.2643|TWO_SIDED|95.0|-0.54|0.15||No adjustments for multiple comparisons were made and a value of p\<0.05 was considered statistically significant.|ANCOVA|||Change from baseline in HbA1c was analyzed using an analysis of covariance model with change in HbA1c as the dependent variable, treatment as a fixed effect, and baseline HbA1c as a covariate.||0.15|-0.54|0.2643
70932272|NCT02307682|141364356|OTHER||Difference in proportions|-14.2|||||TWO_SIDED|95.0|-21.3|-7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||-7.3|-21.3|
71019766|NCT01236053|141546917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.4775|TWO_SIDED|95.0|0.24|1.94|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||1.94|0.24|0.4775
71019767|NCT01236053|141546918|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.33||||0.0032|TWO_SIDED|95.0|1.95|27.56|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||27.56|1.95|0.0032
71019768|NCT01236053|141546918|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.39||||0.1251|TWO_SIDED|95.0|0.71|16.17|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||16.17|0.71|0.1251
71019769|NCT01236053|141546918|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.22||||0.0261|TWO_SIDED|95.0|1.15|9.01|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||9.01|1.15|0.0261
71019770|NCT01236053|141546918|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.16||||0.209|TWO_SIDED|95.0|0.65|7.17|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||7.17|0.65|0.2090
71019771|NCT01236053|141546919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.0||||0.0144|TWO_SIDED|95.0|1.81|220.5|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||220.5|1.81|0.0144
71019772|NCT01236053|141546919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.47||||0.0158|TWO_SIDED|95.0|1.78|258.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||258.8|1.78|0.0158
71052536|NCT05958888|141609687|SUPERIORITY||Mean Difference (Final Values)|1.76|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||<.001
71052537|NCT05958888|141609687|SUPERIORITY||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||<.001
71052538|NCT05958888|141609687|SUPERIORITY||Mean Difference (Final Values)|0.87|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||<.001
71052539|NCT05958888|141609687|SUPERIORITY||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||<.001
71052540|NCT05958888|141609687|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.17||0.72|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.72
71106063|NCT00867035|141718728|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||Rosenberg scores compared baseline to 1 hour by Mann-Whitney U test.||||<0.001
70932273|NCT02307682|141364356|OTHER||Difference in proportions|-8.4|||||TWO_SIDED|95.0|-14.6|-2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||-2.2|-14.6|
71019773|NCT01236053|141546919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.86||||0.0524|TWO_SIDED|95.0|0.99|15.14|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||15.14|0.99|0.0524
71019774|NCT01236053|141546919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.21||||0.0269|TWO_SIDED|95.0|1.21|22.51|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||22.51|1.21|0.0269
71019775|NCT01236053|141546919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0||||0.1888|TWO_SIDED|95.0|0.45|55.14|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||55.14|0.45|0.1888
71019776|NCT01236053|141546919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.999|TWO_SIDED|95.0|0.03|32.21|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||32.21|0.03|0.9990
71019777|NCT01236053|141546919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.75||||0.2885|TWO_SIDED|95.0|0.33|43.08|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||43.08|0.33|0.2885
71019778|NCT01236053|141546919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.9608|TWO_SIDED|95.0|0.06|13.87|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||13.87|0.06|0.9608
71019779|NCT01236053|141546919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.33||||0.0944|TWO_SIDED|95.0|0.78|24.07|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||24.07|0.78|0.0944
71019780|NCT01236053|141546919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.9253|TWO_SIDED|95.0|0.1|7.82|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||7.82|0.10|0.9253
71019781|NCT01236053|141546920|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.0||||0.0144|TWO_SIDED|95.0|1.81|220.5|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||220.5|1.81|0.0144
71019782|NCT01236053|141546920|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.47||||0.0158|TWO_SIDED|95.0|1.78|258.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||258.8|1.78|0.0158
71019783|NCT01236053|141546920|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.0||||0.0141|TWO_SIDED|95.0|1.43|25.11|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||25.11|1.43|0.0141
71019784|NCT01236053|141546920|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.56||||0.0063|TWO_SIDED|95.0|1.83|40.02|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||40.02|1.83|0.0063
71019785|NCT01236053|141546920|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0||||0.1888|TWO_SIDED|95.0|0.45|55.14|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||55.14|0.45|0.1888
71019786|NCT01236053|141546920|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.999|TWO_SIDED|95.0|0.03|32.21|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||32.21|0.03|0.9990
71019787|NCT01236053|141546920|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.75||||0.2885|TWO_SIDED|95.0|0.33|43.08|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||43.08|0.33|0.2885
71052541|NCT05958888|141609688|SUPERIORITY||Mean Difference (Final Values)|1.73|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||<.001
71052542|NCT05958888|141609688|SUPERIORITY||Mean Difference (Final Values)|2.39|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||<.001
71019788|NCT01236053|141546920|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.9608|TWO_SIDED|95.0|0.06|13.87|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||13.87|0.06|0.9608
71019789|NCT01236053|141546920|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.33||||0.0944|TWO_SIDED|95.0|0.78|24.07|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||24.07|0.78|0.0944
71019790|NCT01236053|141546920|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.9381||95.0|0.11|7.97|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||7.97|0.11|0.9381
71052543|NCT05958888|141609688|SUPERIORITY||Mean Difference (Final Values)|2.11|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||<.001
71052544|NCT05958888|141609688|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||<.001
70851271|NCT00669409|141190534|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-17.0|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-38.8|4.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.8|-38.8|
70932274|NCT02307682|141364356|OTHER||Difference in proportions|-15.0|||||TWO_SIDED|95.0|-20.9|-9.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||-9.5|-20.9|
70932275|NCT02307682|141364356|OTHER||Difference in proportions|-8.1|||||TWO_SIDED|95.0|-13.8|-2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-2.4|-13.8|
71019791|NCT01236053|141546922|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.0||||0.0144|TWO_SIDED|95.0|1.81|220.5|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||220.5|1.81|0.0144
71019792|NCT01236053|141546922|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.55||||0.0157|TWO_SIDED|95.0|1.78|260.2|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||260.2|1.78|0.0157
71019793|NCT01236053|141546922|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.86||||0.0524|TWO_SIDED|95.0|0.99|15.14|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||15.14|0.99|0.0524
71052545|NCT05958888|141609688|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.14||0.01|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||.01
71052546|NCT05958888|141609688|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.14||0.04|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.04
71052547|NCT05958888|141609689|SUPERIORITY||Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||<.001
71052548|NCT05958888|141609689|SUPERIORITY||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||<.001
71052549|NCT05958888|141609689|SUPERIORITY||Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||<.001
71052550|NCT05958888|141609689|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.15||0.43|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||.43
71052551|NCT05958888|141609689|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.15||0.81|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||.81
71052552|NCT05958888|141609689|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.81|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.81
71052553|NCT03244644|141609695|SUPERIORITY||Treatment Difference|13.1|||||TWO_SIDED|95.0|2.3|24.0|||||The Bayesian posterior probability of superiority was 0.99136. This value exceeded the pre-specified threshold of 0.9750338 (nominal 0.025 one-sided level).|A hierarchical, closed-testing procedure (Bayesian hierarchical model) was utilized for the primary endpoint. The Bayesian hierarchical model formally incorporated data from the previous Phase 2B study (NCT02299570) of RBX2660. This analysis tested the hypothesis that the response rate of RBX2660 was superior to Placebo and was performed at the nominal 0.00125 and 0.025 one-sided levels.||24.0|2.3|
70932276|NCT02307682|141364356|OTHER||Difference in proportions|-14.0|||||TWO_SIDED|95.0|-18.9|-8.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-8.7|-18.9|
70932277|NCT02307682|141364356|OTHER||Difference in proportions|-10.4|||||TWO_SIDED|95.0|-16.8|-3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-3.7|-16.8|
70932278|NCT02307682|141364356|OTHER||Difference in proportions|-19.7|||||TWO_SIDED|95.0|-25.8|-13.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-13.4|-25.8|
71019794|NCT01236053|141546922|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.8||||0.0333|TWO_SIDED|95.0|1.13|20.31|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||20.31|1.13|0.0333
71019795|NCT01236053|141546922|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.34||||0.2966|TWO_SIDED|95.0|0.35|32.06|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||32.06|0.35|0.2966
71106064|NCT00867035|141718728|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||mann whitney u to compare rosenberg score baseline to 1 hour||||<.001
71106065|NCT00867035|141718728|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||baseline to 2 hours||||<0.001
71106066|NCT00867035|141718728|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||baseline to 4 hours||||<0.001
71106067|NCT00867035|141718728|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||baseline to 1 week||||<0.001
71106068|NCT00867035|141718728|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||baseline to 2 hours||||<0.01
71019796|NCT01236053|141546922|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62||||0.751|TWO_SIDED|95.0|0.03|12.31|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||12.31|0.03|0.7510
71019797|NCT01236053|141546922|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.71||||0.1868|TWO_SIDED|95.0|0.4|113.4|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||113.4|0.40|0.1868
71019798|NCT01236053|141546922|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.7558|TWO_SIDED|95.0|0.07|40.61|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||40.61|0.07|0.7558
71106069|NCT00867035|141718728|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||baseline to 4 hours||||<0.01
71106070|NCT00867035|141718728|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||baseline to 1 week||||<0.05
71106071|NCT00867035|141718729|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of H2S in mouth air at 1 hour analyzed between groups.||||>0.05
70851272|NCT00669409|141190535|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-22.2|11.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.2|-22.2|
71019799|NCT01236053|141546922|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.33||||0.0944|TWO_SIDED|95.0|0.78|24.07|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||24.07|0.78|0.0944
70851273|NCT00669409|141190535|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.5|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-36.1|-2.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.9|-36.1|
71019800|NCT01236053|141546922|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.9244|TWO_SIDED|95.0|0.1|7.81|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||7.81|0.10|0.9244
71019801|NCT01236053|141546923|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.0963|TWO_SIDED|95.0|0.96|1.7|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||1.70|0.96|0.0963
71019802|NCT01236053|141546923|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.671|TWO_SIDED|95.0|0.69|1.27|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.27|0.69|0.6710
71106072|NCT00867035|141718730|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of H2S in mouth air at 2 hours analyzed between groups. Each time point was compared between groups by Students t test.||||>0.05
71106073|NCT00867035|141718731|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of H2S in mouth air at 4 hours analyzed between groups||||>0.05
71106074|NCT00867035|141718732|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of H2S in mouth air at 1 week analyzed between groups. Each time point was compared between groups by Students t test.||||>0.05
71106075|NCT00867035|141718733|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of MM in mouth air at 1 hour analyzed between groups||||>0.05
71106076|NCT00867035|141718734|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of MM in mouth air at 2 hours analyzed between groups. Each time point was compared between groups by Students t test||||>0.05
71106077|NCT00867035|141718735|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of MM in mouth air at 4 hours analyzed between groups. Each time point was compared between groups by Students t test.||||>0.05
71106078|NCT00867035|141718736|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrtations of MM in mouth air at 1 week analyzed between groups. Each time point was compared between groups by Students t test||||>0.05
71106079|NCT00867035|141718737|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Counts of colony forming units from swab of 1square centimeter area on tongue at 1 week cultured on anaerobe plates for 1 week analyzed between groups||||>0.05
71106080|NCT00867035|141718738|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Percentage of black colonies out of Total Viable Count cultured on anaerobe agar with lead acetate. Black colonies are those producing sulfides (H2S, MM)and creating black lead sulfide. Analyzed between groups. Groups compared at baseline and 1 week.||||>0.05
71106081|NCT00404248|141718747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.9|ONE_SIDED||||||t-test, 2 sided|||||||0.9
71106082|NCT00404248|141718748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.4||||0.6|TWO_SIDED||||||t-test, 2 sided|||||||0.6
71106083|NCT00404248|141718749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4||||0.8|TWO_SIDED||||||t-test, 2 sided|||||||0.8
71106084|NCT04066829|141718791|OTHER||Difference in Differences|-29.2|||||TWO_SIDED|95.0|-42.2|-11.8||||||Pre and post difference in the treatment group as compared to the control group. A log transformation was used.||-11.8|-42.2|
71106085|NCT00285779|141718856|SUPERIORITY_OR_OTHER|||||||0.0978|TWO_SIDED||||||Fisher Exact|||||||0.0978
71106086|NCT00285779|141718857|OTHER||||||>|0.9999|||||||Fisher Exact|||||||>0.9999
71106087|NCT00285779|141718858|OTHER|||||||0.031|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.031
71106088|NCT00285779|141718858|OTHER|||||||0.34|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.34
71106089|NCT00285779|141718858|OTHER|||||||0.13|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.13
71106090|NCT00285779|141718858|OTHER|||||||0.22|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.22
71106091|NCT00285779|141718859|OTHER||||||>|0.9999|||||||Wilcoxon Paired|||Week 12 versus baseline||||>0.9999
71052554|NCT03244644|141609696|SUPERIORITY|||||||0.156||||||P-value for secondary outcome evaluated from baseline through 6 months|Chi-squared|||||||0.156
71052555|NCT01007942|141609736|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0067|TWO_SIDED|95.0|0.65|0.95|||Log Rank|||||0.95|0.65|0.0067
71052556|NCT04040322|141609787|SUPERIORITY||Least squares mean difference in change|-1.26||||0.421|TWO_SIDED|95.0|-4.34|1.82||Threshold for statistical significance was p \< 0.05|ANCOVA|||||1.82|-4.34|0.4210
71052557|NCT03056157|141609791|SUPERIORITY||Slope|-0.236||||0.03|TWO_SIDED|95.0|-3.34|-0.18|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores, t(1519 )= -2.19, d = 0.15.||-0.18|-3.34|0.03
71019803|NCT01236053|141546923|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84|||<|0.0001|TWO_SIDED|95.0|1.54|2.2|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||2.20|1.54|<0.0001
71019804|NCT01236053|141546923|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5|||<|0.0001|TWO_SIDED|95.0|1.24|1.81|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.81|1.24|<0.0001
71019805|NCT01236053|141546924|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.1184|TWO_SIDED|95.0|0.92|2.18|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||2.18|0.92|0.1184
71019806|NCT01236053|141546924|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.8016|TWO_SIDED|95.0|0.59|1.5|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.50|0.59|0.8016
71019807|NCT01236053|141546924|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.27|||<|0.0001|TWO_SIDED|95.0|1.77|2.91|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||2.91|1.77|<0.0001
71052558|NCT03056157|141609791|SUPERIORITY||Slope|-8.97|||<|0.001|TWO_SIDED|95.0|-10.12|-6.11|||Mixed Models Analysis|||In a mixed model analysis of intent-to- treat data for SDS scores, t(160)= -15.74, d = 2.97.||-6.11|-10.12|<.001
71052559|NCT03056157|141609791|SUPERIORITY||Slope|-6.62|||<|0.001|TWO_SIDED|95.0|-8.35|-6.11|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores, t(160) = -12.72, d = 1.86.||-6.11|-8.35|<0.001
71052560|NCT03056157|141609791|SUPERIORITY||Slope|-0.65||||0.49|TWO_SIDED|95.0|-2.13|0.86|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores, t(1510) = -0.90, d = 0.05.||0.86|-2.13|0.49
71052561|NCT03056157|141609791|SUPERIORITY||Slope|1.1|||<|0.001|TWO_SIDED|95.0|0.06|2.17|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores, t(1510) = 2.11, d = 0.11.||2.17|0.06|<0.001
71052562|NCT03056157|141609791|SUPERIORITY||Slope|1.75|||<|0.001|TWO_SIDED|95.0|0.75|2.81|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores, t(1510) = 3.45, d = 0.18||2.81|0.75|<0.001
71052563|NCT03056157|141609792|SUPERIORITY||Odds Ratio (OR)|2.35||||0.03|TWO_SIDED|95.0|1.01|5.56|||Fisher Exact|||Odds ratio comparison of the proportions of participants who experienced probable recovery in SDS from baseline to post-treatment in AD-MIL versus PCT.||5.56|1.01|0.03
71019808|NCT01236053|141546924|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.97|||<|0.0001|TWO_SIDED|95.0|1.51|2.58|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.58|1.51|<0.0001
71019809|NCT01236053|141546924|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.6105|TWO_SIDED|95.0|0.65|2.08|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.08|0.65|0.6105
71019810|NCT01236053|141546924|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.6797|TWO_SIDED|95.0|0.62|2.09|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.09|0.62|0.6797
71019811|NCT01236053|141546924|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.0103|TWO_SIDED|95.0|1.12|2.39|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.39|1.12|0.0103
71019812|NCT01236053|141546924|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.1629|TWO_SIDED|95.0|0.89|2.0|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.00|0.89|0.1629
71019813|NCT01236053|141546924|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.4713|TWO_SIDED|95.0|0.73|1.97|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.97|0.73|0.4713
71019814|NCT01236053|141546924|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.4505|TWO_SIDED|95.0|0.49|1.38|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.38|0.49|0.4505
71052564|NCT03056157|141609792|SUPERIORITY||Odds Ratio (OR)|0.0||||0.01|TWO_SIDED|95.0|0.0|0.71|||Fisher Exact|||Odds ratio comparison of the proportion of participants who experienced improvement from baseline to post-treatment in SDS in AD-MIL versus PCT.||0.71|0|0.01
71052565|NCT03056157|141609792|SUPERIORITY||Odds Ratio (OR)|0.82||||0.69|TWO_SIDED|95.0|0.35|1.87|||Fisher Exact|||Odds ratio comparison of the proportion of participants who experienced no change in SDS from baseline to post-treatment in AD-MIL versus PCT.||1.87|0.35|.69
71052566|NCT03056157|141609792|SUPERIORITY||Odds Ratio (OR)|0.0||||0.5|TWO_SIDED|0.0|0.0|5.83|||Fisher Exact|||Odds ratio comparison of the proportion of participants who experienced deterioration in SDS from baseline to post-treatment in AD-MIL versus PCT.||5.83|0|0.50
71052567|NCT03056157|141609793|SUPERIORITY||Slope|-3.39||||0.35|TWO_SIDED|95.0|-10.57|3.79|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for B-IPF scores, t(326) = -0.93, d = 0.10.||3.79|-10.57|0.35
71052568|NCT03056157|141609793|SUPERIORITY||Slope|-8.64||||0.001|TWO_SIDED|95.0|-13.83|-3.44|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for BIPF scores, t(116) = -3.27, d = 0.61.||-3.44|-13.83|0.001
71052569|NCT03056157|141609793|SUPERIORITY||Slope|-5.25||||0.04|TWO_SIDED|95.0|-10.21|-0.29|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for B-IPF scores, t(116) = -2.08, d = 0.39.||-0.29|-10.21|0.04
71106092|NCT00285779|141718859|OTHER||||||>|0.9999|||||||Wilcoxon Paired|||Week 24 versus baseline||||>0.9999
71019815|NCT01236053|141546924|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.0284|TWO_SIDED|95.0|1.04|2.01|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.01|1.04|0.0284
71019816|NCT01236053|141546924|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.6262|TWO_SIDED|95.0|0.77|1.54|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.54|0.77|0.6262
71019817|NCT01236053|141546925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.0798|TWO_SIDED|95.0|0.95|2.41|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||2.41|0.95|0.0798
71019818|NCT01236053|141546925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.8357|TWO_SIDED|95.0|0.64|1.73|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.73|0.64|0.8357
71019819|NCT01236053|141546925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.29|||<|0.0001|TWO_SIDED|95.0|1.75|3.01|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||3.01|1.75|<0.0001
71019820|NCT01236053|141546925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05|||<|0.0001|TWO_SIDED|95.0|1.53|2.76|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.76|1.53|<0.0001
71019821|NCT01236053|141546925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.7794|TWO_SIDED|95.0|0.63|1.85|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.85|0.63|0.7794
71019822|NCT01236053|141546925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.8075|TWO_SIDED|95.0|0.52|1.66|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.66|0.52|0.8075
71019823|NCT01236053|141546925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.0001|TWO_SIDED|95.0|1.35|2.52|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.52|1.35|0.0001
71019824|NCT01236053|141546925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.0161|TWO_SIDED|95.0|1.08|2.12|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.12|1.08|0.0161
71019825|NCT01236053|141546925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.3972|TWO_SIDED|95.0|0.76|2.0|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.00|0.76|0.3972
71019826|NCT01236053|141546925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.495|TWO_SIDED|95.0|0.5|1.39|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.39|0.50|0.4950
71019827|NCT01236053|141546925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.0601|TWO_SIDED|95.0|0.99|1.94|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.94|0.99|0.0601
71019828|NCT01236053|141546925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.9286|TWO_SIDED|95.0|0.71|1.45|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.45|0.71|0.9286
71019829|NCT01236053|141546926|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.5394|TWO_SIDED|95.0|0.63|2.39|||Conditional Logistic Regression||"Comparison: \> 1 year (with 2 year lag) and Never (with 2 year lag)."|||2.39|0.63|0.5394
71019830|NCT01236053|141546926|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.507|TWO_SIDED|95.0|0.39|1.58|||Conditional Logistic Regression||"Comparison: \> 1 year (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.58|0.39|0.5070
71019831|NCT01236053|141546926|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.5426|TWO_SIDED|95.0|0.73|1.83|||Conditional Logistic Regression||"Comparison: \> 1 year (without 2 year lag) and Never (without 2 year lag)."|||1.83|0.73|0.5426
71019832|NCT01236053|141546926|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.515|TWO_SIDED|95.0|0.52|1.38|||Conditional Logistic Regression||"Comparison: \> 1 year (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.38|0.52|0.5150
71019833|NCT01236053|141546926|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.435|TWO_SIDED|95.0|0.53|4.42|||Conditional Logistic Regression||"Comparison: \> 2 years (with 2 year lag) and Never (with 2 year lag)."|||4.42|0.53|0.4350
71019834|NCT01236053|141546926|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13||||0.8276|TWO_SIDED|95.0|0.37|3.43|||Conditional Logistic Regression||"Comparison: \> 2 years (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||3.43|0.37|0.8276
71019835|NCT01236053|141546926|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.4022|TWO_SIDED|95.0|0.69|2.5|||Conditional Logistic Regression||"Comparison: \> 2 years (without 2 year lag) and Never (without 2 year lag)."|||2.50|0.69|0.4022
71019836|NCT01236053|141546926|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.8681|TWO_SIDED|95.0|0.48|1.86|||Conditional Logistic Regression||"Comparison: \> 2 years (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.86|0.48|0.8681
71019837|NCT01236053|141546926|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.6326|TWO_SIDED|95.0|0.2|13.86|||Conditional Logistic Regression||"Comparison: \> 3 years (with 2 year lag) and Never (with 2 year lag)."|||13.86|0.20|0.6326
71019838|NCT01236053|141546926|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87||||0.577|TWO_SIDED|95.0|0.21|16.86|||Conditional Logistic Regression||"Comparison: \> 3 years (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||16.86|0.21|0.5770
71019839|NCT01236053|141546926|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.8087|TWO_SIDED|95.0|0.4|3.21|||Conditional Logistic Regression||"Comparison: \> 3 years (without 2 year lag) and Never (without 2 year lag)."|||3.21|0.40|0.8087
71052570|NCT03056157|141609793|SUPERIORITY||Slope|-5.17||||0.08|TWO_SIDED|95.0|-10.86|0.52|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for B-IPF scores, t(326) = -1.79, d = 0.20.||0.52|-10.86|0.08
71052571|NCT03056157|141609793|SUPERIORITY||Slope|-5.64||||0.007|TWO_SIDED|95.0|-9.72|-1.57|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for B-IPF scores, t(326) = -2.72, d = 0.30.||-1.57|-9.72|0.007
71052572|NCT03056157|141609793|SUPERIORITY||Slope|-0.47||||0.82|TWO_SIDED|95.0|-4.44|3.5|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for B-IPF scores, t(326) = -0.23, d = 0.03.||3.50|-4.44|0.82
71052573|NCT03056157|141609794|SUPERIORITY||Slope|-0.6||||0.75|TWO_SIDED|95.0|-4.68|3.36|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores for the COVID-19 cohort, t(373) = -0.32, d = 0.03.||3.36|-4.68|0.75
71052574|NCT03056157|141609794|SUPERIORITY||Slope|-9.12|||<|0.001|TWO_SIDED|95.0|-12.12|-6.12|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores for the COVID-19 cohort, t(37) = -6.01, d = 1.97.||-6.12|-12.12|<0.001
71052575|NCT03056157|141609794|SUPERIORITY||Slope|-8.72|||<|0.001|TWO_SIDED|95.0|-11.16|-5.76|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores for the COVID-19 cohort, t(37) = -6.11, d = 2.01.||-5.76|-11.16|<0.001
71052576|NCT03056157|141609794|SUPERIORITY||Slope|-2.28||||0.56|TWO_SIDED|95.0|-10.08|5.52|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores for the COVID-19 cohort, t(373) = -0.59, d = 0.06.||5.52|-10.08|0.56
71052577|NCT03056157|141609794|SUPERIORITY||Slope|4.2||||0.22|TWO_SIDED|95.0|-0.24|10.92|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores for the COVID-19 cohort, t(373) = 1.25, d = 0.13.||10.92|-0.24|0.22
71052578|NCT03056157|141609794|SUPERIORITY||Slope|6.6||||0.002|TWO_SIDED|95.0|2.52|10.69|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores for the COVID-19 cohort, t(373) = 3.18, d = 0.33.||10.69|2.52|0.002
71106093|NCT00285779|141718860|OTHER|||||||0.25|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.25
71106094|NCT00285779|141718860|OTHER||||||>|0.9999|||||||Wilcoxon Paired|||Week 12 versus baseline||||>0.9999
71106095|NCT00285779|141718860|OTHER|||||||0.063|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.063
70851274|NCT00669409|141190535|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-15.6|17.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.7|-15.6|
71052579|NCT03056157|141609795|SUPERIORITY||Slope|0.48||||0.92|TWO_SIDED|95.0|-9.6|10.69|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores for the COVID-19 cohort, t(367) = 0.10, d = 0.01.||10.69|-9.60|0.92
70932279|NCT02307682|141364356|OTHER||Difference in proportions|4.1|||||TWO_SIDED|95.0|-2.0|9.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||9.9|-2.0|
71052580|NCT03056157|141609795|SUPERIORITY||Slope|-16.08|||<|0.001|TWO_SIDED|95.0|-23.64|-8.52|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores for the COVID-19 cohort, t(37) = -4.23, d = 1.39.||-8.52|-23.64|<0.001
71106096|NCT00285779|141718860|OTHER||||||>|0.9999|||||||Wilcoxon Paired|||Week 24 versus baseline||||>0.9999
71106097|NCT00285779|141718861|OTHER|||||||0.063|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.063
71052581|NCT03056157|141609795|SUPERIORITY||Slope|-16.56|||<|0.001|TWO_SIDED|95.0|-23.4|-9.72|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores for the COVID-19 cohort, t(37) = -4.77, d = 1.57.||-9.72|-23.40|<0.001
71052582|NCT03056157|141609795|SUPERIORITY||Slope|-26.28||||0.002|TWO_SIDED|95.0|-42.6|-9.84|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores for the COVID-19 cohort, t(367) = -3.15, d = 0.33.||-9.84|-42.60|0.002
71052583|NCT03056157|141609795|SUPERIORITY||Slope|-18.72||||0.01|TWO_SIDED|95.0|-32.4|-4.92|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores for the COVID-19 cohort, t(37) = -2.67, d = 0.28.||-4.92|-32.40|0.01
71052584|NCT03056157|141609795|SUPERIORITY||Slope|-5.25||||0.04|TWO_SIDED|95.0|-10.21|-0.29|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for B- IPF scores, the Pre-Post PCT Time slope was -5.25 \[95% CI = -10.21, -0.29\], p-value = 0.04, t(116) = -2.08, d = 0.39.||-0.29|-10.21|0.04
71052585|NCT03056157|141609796|SUPERIORITY||Slope|-6.38||||0.1|TWO_SIDED|95.0|-13.97|1.22|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores for the COVID-19 cohort, t(49) = -1.69, d = 0.48.||1.22|-13.97|0.10
71052586|NCT03056157|141609796|SUPERIORITY||Slope|-13.29|||<|0.001|TWO_SIDED|95.0|-18.96|-7.62|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores for the COVID-19 cohort, t(32) = -4.71, d = 1.67.||-7.62|-18.96|<0.001
71106098|NCT00285779|141718861|OTHER|||||||0.25|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.25
71106099|NCT00285779|141718861|OTHER|||||||0.031|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.031
71052587|NCT03056157|141609796|SUPERIORITY||Slope|-6.92||||0.001|TWO_SIDED|95.0|-11.96|-1.87|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores for the COVID-19 cohort, t(32) = -2.75, d = 0.97.||-1.87|-11.96|0.001
71106100|NCT00285779|141718861|OTHER|||||||0.32|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.32
71106101|NCT00285779|141718862|OTHER|||||||0.094|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.094
71106102|NCT00285779|141718862|OTHER|||||||0.25|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.25
71106103|NCT00285779|141718862|OTHER|||||||0.13|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.13
71106104|NCT00285779|141718862|OTHER|||||||0.13|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.13
71106105|NCT00285779|141718863|OTHER|||||||0.63|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.63
71106106|NCT00285779|141718863|OTHER|||||||0.38|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.38
71106107|NCT00285779|141718863|OTHER|||||||0.38|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.38
71106108|NCT00285779|141718863|OTHER|||||||0.5|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.50
71106109|NCT00285779|141718864|OTHER|||||||0.031|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.031
71106110|NCT00285779|141718864|OTHER|||||||0.094|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.094
71052588|NCT03056157|141609796|SUPERIORITY||Slope|5.22||||0.34|TWO_SIDED|95.0|-5.6|16.05|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores for the COVID-19 cohort, t(49) = 0.97, d = 0.28.||16.05|-5.60|0.34
71052589|NCT03056157|141609796|SUPERIORITY||Slope|5.93||||0.17|TWO_SIDED|95.0|-2.55|14.41|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores for the COVID-19 cohort, t(49) = 1.40, d = 0.40.||14.41|-2.55|0.17
71052590|NCT03056157|141609796|SUPERIORITY||Slope|0.7||||0.83|TWO_SIDED|95.0|-6.04|7.44|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores for the COVID-19 cohort, t(49) = 0.21, d = 0.06.||7.44|-6.04|0.83
71052591|NCT03056157|141609797|SUPERIORITY||Slope|0.6||||0.76|TWO_SIDED|95.0|-3.12|4.2|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores for the COVID-19 cohort, t(373) = 0.30, d = 0.03.||4.20|-3.12|0.76
71019840|NCT01236053|141546926|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.8497|TWO_SIDED|95.0|0.31|2.64|||Conditional Logistic Regression||"Comparison: \> 3 years (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.64|0.31|0.8497
71019841|NCT01236053|141546927|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.1528|TWO_SIDED|95.0|0.88|2.24|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||2.24|0.88|0.1528
71019842|NCT01236053|141546927|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.9625|TWO_SIDED|95.0|0.62|1.65|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.65|0.62|0.9625
71019843|NCT01236053|141546927|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96|||<|0.0001|TWO_SIDED|95.0|1.48|2.59|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||2.59|1.48|<0.0001
71052592|NCT03056157|141609797|SUPERIORITY||Slope|-3.12||||0.002|TWO_SIDED|95.0|-6.96|-1.56|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores for the COVID-19 cohort, t(37) = -3.14, d = 1.03.||-1.56|-6.96|0.002
71052593|NCT03056157|141609797|SUPERIORITY||Slope|-4.92|||<|0.001|TWO_SIDED|95.0|-7.32|-2.4|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores for the COVID-19 cohort, t(37) = -3.88, d = 1.27.||-2.40|-7.32|<0.001
71052594|NCT03056157|141609797|SUPERIORITY||Slope|-4.8||||0.13|TWO_SIDED|95.0|-11.16|1.44|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores for the COVID-19 cohort, t(373) = -1.50, d = 0.16.||1.44|-11.16|0.13
71052595|NCT03056157|141609797|SUPERIORITY||Slope|-2.4||||0.38|TWO_SIDED|95.0|-7.68|3.0|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores for the COVID-19 cohort, t(373) = -0.87, d = 0.09.||3.00|-7.68|0.38
71052596|NCT03056157|141609797|SUPERIORITY||Slope|2.4||||0.26|TWO_SIDED|95.0|-0.96|5.88|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores for the COVID-19 cohort, t(373) = 1.42, d = 0.15.||5.88|-0.96|0.26
71052597|NCT03056157|141609798|SUPERIORITY||Slope|-6.65|||<|0.001|TWO_SIDED|95.0|-10.23|-3.07|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores, t(348) = -3.65, d = 0.39.||-3.07|-10.23|<0.001
71052598|NCT03056157|141609798|SUPERIORITY||Slope|-11.88|||<|0.001|TWO_SIDED|95.0|-14.43|-9.32|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores, t(131) = -9.14, d = 1.60.||-9.32|-14.43|<0.001
71052599|NCT03056157|141609798|SUPERIORITY||Slope|-5.23|||<|0.001|TWO_SIDED|95.0|-7.74|-2.72|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores, t(131) = -4.10, d = 0.72.||-2.72|-7.74|<0.001
71052600|NCT03056157|141609798|SUPERIORITY||Slope|1.36||||0.39|TWO_SIDED|95.0|-1.73|4.45|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores, t(348) = 0.87, d = 0.09.||4.45|-1.73|0.39
71052601|NCT03056157|141609798|SUPERIORITY||Slope|0.08||||0.94|TWO_SIDED|95.0|-2.1|2.26|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores, t(348) = 0.07, d = 0.001.||2.26|-2.10|0.94
71052602|NCT03056157|141609798|SUPERIORITY||Slope|-1.28||||0.25|TWO_SIDED|95.0|-3.48|0.91|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores, t(348) = -1.15, d = 0.12.||0.91|-3.48|0.25
71052603|NCT03056157|141609799|SUPERIORITY||Odds Ratio (OR)|6.44||||0.01|TWO_SIDED|95.0|1.29|63.18|||Fisher Exact|||Odds ratio comparison of the proportions of participants who experienced probable recovery in CAPS-5 from baseline to post-treatment in AD-MIL versus PCT.||63.18|1.29|0.01
71052604|NCT03056157|141609799|SUPERIORITY||Odds Ratio (OR)|1.51||||0.4|TWO_SIDED|95.0|0.61|3.75|||Fisher Exact|||Odds ratio comparison of the proportions of participants who experienced improvement in CAPS-5 from baseline to post-treatment in AD-MIL versus PCT.||3.75|0.61|0.40
71052605|NCT03056157|141609799|SUPERIORITY||Odds Ratio (OR)|0.78||||0.58|TWO_SIDED|95.0|0.36|1.7|||Fisher Exact|||Odds ratio comparison of the proportions of participants who experienced no change in CAPS-5 from baseline to post-treatment in AD-MIL versus PCT.||1.70|0.36|0.58
71052606|NCT03056157|141609799|SUPERIORITY||Odds Ratio (OR)|0.15||||0.06|TWO_SIDED|95.0|0.003|1.2|||Fisher Exact|||Odds ratio comparison of the proportions of participants who experienced deterioration in CAPS-5 from baseline to post-treatment in AD-MIL versus PCT.||1.20|0.003|0.06
71052607|NCT03056157|141609800|SUPERIORITY||Odds Ratio (OR)|0.49||||0.07|TWO_SIDED|95.0|0.22|1.06|||Fisher Exact|||Odds ratio comparison of the proportions of participants with a PTSD Diagnosis in CAPS-5 at post-treatment in AD-MIL versus PCT.||1.06|0.22|0.07
71052608|NCT03056157|141609800|SUPERIORITY||Odds Ratio (OR)|0.66||||0.33|TWO_SIDED|95.0|0.28|1.56|||Fisher Exact|||Odds ratio comparison of the proportions of participants with PTSD Diagnosis in CAPS-5 at 3MFU in AD-MIL versus PCT.||1.56|0.28|0.33
71052609|NCT03056157|141609800|SUPERIORITY||Odds Ratio (OR)|0.42||||0.05|TWO_SIDED|95.0|0.15|1.08|||Fisher Exact|||Odds ratio comparison of the proportions of participants with PTSD Diagnosis in CAPS-5 at 6MFU in AD-MIL versus PCT.||1.08|0.15|0.05
71052610|NCT03056157|141609801|SUPERIORITY||Slope|-4.63||||0.003|TWO_SIDED|95.0|-7.16|-2.1|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores, t(1542) = -3.01, d = 0.13.||-2.10|-7.16|.003
71052611|NCT03056157|141609801|SUPERIORITY||Slope|-12.62|||<|0.001|TWO_SIDED|95.0|-14.43|-10.8|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores, t(161) = -11.50, d = 1.81.||-10.80|-14.43|<0.001
71106111|NCT00285779|141718864|OTHER|||||||0.039|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.039
70932280|NCT02307682|141364356|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-4.3|7.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||7.9|-4.3|
70932281|NCT02307682|141364356|OTHER||Difference in proportions|-12.7|||||TWO_SIDED|95.0|-19.1|-6.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-6.0|-19.1|
70932282|NCT02307682|141364356|OTHER||Difference in proportions|-23.4|||||TWO_SIDED|95.0|-29.7|-17.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-17.6|-29.7|
70932283|NCT02307682|141364356|OTHER||Difference in proportions|-2.8|||||TWO_SIDED|95.0|-8.7|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||3.4|-8.7|
70932284|NCT02307682|141364356|OTHER||Difference in proportions|-5.1|||||TWO_SIDED|95.0|-11.2|0.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||0.4|-11.2|
71019844|NCT01236053|141546927|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.0006|TWO_SIDED|95.0|1.25|2.29|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.29|1.25|0.0006
71019845|NCT01236053|141546927|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.3515|TWO_SIDED|95.0|0.76|2.16|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.16|0.76|0.3515
71019846|NCT01236053|141546927|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.9069|TWO_SIDED|95.0|0.59|1.82|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.82|0.59|0.9069
71019847|NCT01236053|141546927|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39|||<|0.0001|TWO_SIDED|95.0|1.78|3.21|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.21|1.78|<0.0001
71019848|NCT01236053|141546927|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04|||<|0.0001|TWO_SIDED|95.0|1.48|2.81|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.81|1.48|<0.0001
71019849|NCT01236053|141546927|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.5948|TWO_SIDED|95.0|0.7|1.88|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.88|0.70|0.5948
71019850|NCT01236053|141546927|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.3984|TWO_SIDED|95.0|0.47|1.35|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.35|0.47|0.3984
70932285|NCT02307682|141364356|OTHER||Difference in proportions|-7.7|||||TWO_SIDED|95.0|-14.3|-1.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||-1.0|-14.3|
70932286|NCT02307682|141364356|OTHER||Difference in proportions|-12.4|||||TWO_SIDED|95.0|-19.3|-6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||-6.2|-19.3|
70932287|NCT02307682|141364356|OTHER||Difference in proportions|-7.8|||||TWO_SIDED|95.0|-13.2|-2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-2.2|-13.2|
70932288|NCT02307682|141364356|OTHER||Difference in proportions|-10.3|||||TWO_SIDED|95.0|-15.9|-4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-4.9|-15.9|
70932289|NCT02307682|141364356|OTHER||Difference in proportions|-5.6|||||TWO_SIDED|95.0|-11.5|0.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||0.9|-11.5|
71019851|NCT01236053|141546927|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.1872|TWO_SIDED|95.0|0.89|1.79|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.79|0.89|0.1872
71019852|NCT01236053|141546927|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.6772|TWO_SIDED|95.0|0.64|1.34|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.34|0.64|0.6772
71019853|NCT01236053|141546928|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.4933|TWO_SIDED|95.0|0.07|3.72|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||3.72|0.07|0.4933
71052612|NCT03056157|141609801|SUPERIORITY||Slope|-7.89|||<|0.001|TWO_SIDED|95.0|-9.77|-6.2|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores, t(161) = -7.40, d = 1.16.||-6.20|-9.77|<0.001
71052613|NCT03056157|141609801|SUPERIORITY||Slope|-0.75||||0.65|TWO_SIDED|95.0|-4.01|2.52|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores, t(1542) = -0.45, d = 0.02.||2.52|-4.01|0.65
71052614|NCT03056157|141609801|SUPERIORITY||Slope|2.3||||0.05|TWO_SIDED|95.0|-0.03|4.63|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores, t(1542) = 1.94, d = 0.10.||4.63|-0.03|0.05
71052615|NCT03056157|141609801|SUPERIORITY||Slope|3.04||||0.001|TWO_SIDED|95.0|0.75|5.34|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores, t(1542) = 2.61, d = 0.13.||5.34|0.75|0.001
71052616|NCT03056157|141609802|SUPERIORITY||Odds Ratio (OR)|2.39||||0.04|TWO_SIDED|95.0|1.01|5.84|||Fisher Exact|||Odds ratio comparison of the proportions of participants experiencing probable recovery in PCL-5 at post-treatment in AD-MIL versus PCT.||5.84|1.01|0.04
71052617|NCT03056157|141609802|SUPERIORITY||Odds Ratio (OR)|0.7||||0.49|TWO_SIDED|95.0|0.25|1.95|||Fisher Exact|||Odds ratio comparison of the proportions of participants experiencing improvement in PCL-5 at post-treatment in AD-MIL versus PCT.||1.95|0.25|0.49
71052618|NCT03056157|141609802|SUPERIORITY||Odds Ratio (OR)|0.58||||0.18|TWO_SIDED|95.0|0.25|1.32|||Fisher Exact|||Odds ratio comparison of the proportions of participants experiencing no change in PCL-5 at post-treatment in AD-MIL versus PCT.||1.32|0.25|0.18
71106112|NCT00285779|141718864|OTHER|||||||0.19|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.19
71106113|NCT00285779|141718865|OTHER|||||||0.26|||||||Paired t test|||Week 12 versus baseline||||0.26
71106114|NCT00285779|141718865|OTHER|||||||0.55|||||||Paired t test|||Week 12 versus baseline||||0.55
71106115|NCT00285779|141718865|OTHER|||||||0.18|||||||Paired t test|||Week 24 versus baseline||||0.18
71019854|NCT01236053|141546928|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.4147|TWO_SIDED|95.0|0.06|3.27|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||3.27|0.06|0.4147
71106116|NCT00285779|141718865|OTHER|||||||0.13|||||||Paired t test|||Week 24 versus baseline||||0.13
71019855|NCT01236053|141546929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.8257|TWO_SIDED|95.0|0.15|10.38|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||10.38|0.15|0.8257
71106117|NCT00285779|141718866|OTHER|||||||0.51|||||||Paired t test|||Week 12 versus baseline||||0.51
71106118|NCT00285779|141718866|OTHER|||||||0.47|||||||Paired t test|||Week 24 versus baseline||||0.47
71106119|NCT00285779|141718866|OTHER|||||||0.087|||||||Paired t test|||Week 24 versus baseline||||0.087
71019856|NCT01236053|141546929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.9467|TWO_SIDED|95.0|0.13|9.02|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||9.02|0.13|0.9467
71019857|NCT01236053|141546929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.9859|TWO_SIDED|95.0|0.0|0.0|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||0.00|0.00|0.9859
71019858|NCT01236053|141546929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.9857|TWO_SIDED|95.0|0.0|0.0|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||0.00|0.00|0.9857
71019859|NCT01236053|141546929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.986|TWO_SIDED|95.0|0.0|0.0|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||0.00|0.00|0.9860
71019860|NCT01236053|141546929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.9858|TWO_SIDED|95.0|0.0|0.0|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||0.00|0.00|0.9858
71019861|NCT01236053|141546929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.9798|TWO_SIDED|95.0|0.0|0.0|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||0.00|0.00|0.9798
71052619|NCT03056157|141609803|SUPERIORITY||Slope|-0.99||||0.14|TWO_SIDED|95.0|-2.29|0.34|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores, t(1550) = -1.46, d = 0.07||0.34|-2.29|0.14
71052620|NCT03056157|141609803|SUPERIORITY||Slope|-5.87|||<|0.001|TWO_SIDED|95.0|-6.8|-4.9|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores, t(161) = -12.41, d = 1.96.||-4.90|-6.80|<0.001
71052621|NCT03056157|141609803|SUPERIORITY||Slope|-4.89|||<|0.001|TWO_SIDED|95.0|-5.82|-3.94|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores, t(161) = -10.29, d = 1.62.||-3.94|-5.82|<0.001
71052622|NCT03056157|141609803|SUPERIORITY||Slope|0.02||||0.68|TWO_SIDED|95.0|-0.99|1.53|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores, t(1550) = 0.42, d = 0.02.||1.53|-0.99|0.68
71052623|NCT03056157|141609803|SUPERIORITY||Slope|1.36||||0.003|TWO_SIDED|95.0|0.48|2.24|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores, t(1550) = 3.02, d = 0.15.||2.24|0.48|0.003
71052624|NCT03056157|141609803|SUPERIORITY||Slope|1.09||||0.02|TWO_SIDED|95.0|0.19|1.99|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores, t(1550) = 2.37, d = 0.12.||1.99|0.19|0.02
71052625|NCT03056157|141609804|SUPERIORITY||Slope|-0.2||||0.18|TWO_SIDED|95.0|-0.49|0.09|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Justification scores, t(314) = -1.35, d = 0.15.||0.09|-0.49|0.18
71106120|NCT00285779|141718866|OTHER|||||||0.86|||||||Paired t test|||Week 24 versus baseline||||0.86
71106121|NCT00285779|141718867|OTHER|||||||0.033|||||||Paired t test|||Week 12 versus baseline||||0.033
71106122|NCT00285779|141718867|OTHER|||||||0.069|||||||Paired t test|||Week 12 versus baseline||||0.069
71106123|NCT00285779|141718867|OTHER|||||||0.015|||||||Paired t test|||Week 24 versus baseline||||0.015
71106124|NCT00285779|141718867|OTHER|||||||0.026|||||||Paired t test|||Week 24 versus baseline||||0.026
71106125|NCT01576783|141718888|OTHER|The reported p-value is for the comparison of the change in Linoleic acid (18:2n-6) mol% between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|-2.2|||<|0.001|TWO_SIDED|95.0|-3.4|0.9||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||0.9|-3.4|<0.001
70932290|NCT02307682|141364356|OTHER||Difference in proportions|-11.4|||||TWO_SIDED|95.0|-17.7|-5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-5.6|-17.7|
70932291|NCT02307682|141364356|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-5.1|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||6.7|-5.1|
70932292|NCT02307682|141364356|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-8.7|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||2.4|-8.7|
70932293|NCT02307682|141364356|OTHER||Difference in proportions|-11.6|||||TWO_SIDED|95.0|-17.8|-5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-5.5|-17.8|
70932294|NCT02307682|141364356|OTHER||Difference in proportions|-15.6|||||TWO_SIDED|95.0|-21.2|-9.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-9.7|-21.2|
70932295|NCT02307682|141364356|OTHER||Difference in proportions|-2.6|||||TWO_SIDED|95.0|-8.0|3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||3.0|-8.0|
71019862|NCT01236053|141546929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.9796|TWO_SIDED|95.0|0.0|0.0|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||0.00|0.00|0.9796
71019863|NCT01236053|141546930|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.6252|TWO_SIDED|95.0|0.2|14.84|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||14.84|0.20|0.6252
71019864|NCT01236053|141546930|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.7208|TWO_SIDED|95.0|0.17|13.28|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||13.28|0.17|0.7208
71019865|NCT01236053|141546932|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.9141|TWO_SIDED|95.0|0.14|9.03|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||9.03|0.14|0.9141
71019866|NCT01236053|141546932|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.9613|TWO_SIDED|95.0|0.12|7.78|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||7.78|0.12|0.9613
70932296|NCT02307682|141364356|OTHER||Difference in proportions|-8.6|||||TWO_SIDED|95.0|-13.7|-3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||-3.4|-13.7|
71019867|NCT01236053|141546933|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.0323|TWO_SIDED|95.0|1.02|1.57|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||1.57|1.02|0.0323
71019868|NCT01236053|141546933|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.0682|TWO_SIDED|95.0|0.99|1.52|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.52|0.99|0.0682
70932297|NCT02307682|141364356|OTHER||Difference in proportions|-6.9|||||TWO_SIDED|95.0|-12.6|-0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||-0.7|-12.6|
71019869|NCT01236053|141546933|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.0326|TWO_SIDED|95.0|1.01|1.4|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||1.40|1.01|0.0326
71019870|NCT01236053|141546933|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.0699|TWO_SIDED|95.0|0.99|1.36|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.36|0.99|0.0699
71019871|NCT01236053|141546934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.2893|TWO_SIDED|95.0|0.86|1.69|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.69|0.86|0.2893
71019872|NCT01236053|141546934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.4301|TWO_SIDED|95.0|0.82|1.61|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.61|0.82|0.4301
71019873|NCT01236053|141546934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.0806|TWO_SIDED|95.0|0.97|1.58|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.58|0.97|0.0806
71019874|NCT01236053|141546934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.1226|TWO_SIDED|95.0|0.95|1.55|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.55|0.95|0.1226
70932298|NCT02307682|141364356|OTHER||Difference in proportions|-9.6|||||TWO_SIDED|95.0|-16.0|-3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||-3.8|-16.0|
70932299|NCT02307682|141364356|OTHER||Difference in proportions|-4.5|||||TWO_SIDED|95.0|-9.9|0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||0.7|-9.9|
70932300|NCT02307682|141364356|OTHER||Difference in proportions|-8.5|||||TWO_SIDED|95.0|-13.9|-3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||-3.4|-13.9|
70932301|NCT02307682|141364356|OTHER||Difference in proportions|-7.4|||||TWO_SIDED|95.0|-13.1|-1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-1.2|-13.1|
70932302|NCT02307682|141364356|OTHER||Difference in proportions|-12.0|||||TWO_SIDED|95.0|-17.8|-6.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-6.0|-17.8|
70932303|NCT02307682|141364356|OTHER||Difference in proportions|2.7|||||TWO_SIDED|95.0|-2.5|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||8.4|-2.5|
70932304|NCT02307682|141364356|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-6.7|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||3.7|-6.7|
70932305|NCT02307682|141364356|OTHER||Difference in proportions|-7.5|||||TWO_SIDED|95.0|-12.8|-1.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-1.6|-12.8|
70932306|NCT02307682|141364356|OTHER||Difference in proportions|-12.5|||||TWO_SIDED|95.0|-18.2|-7.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-7.0|-18.2|
71019875|NCT01236053|141546934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.3502|TWO_SIDED|95.0|0.8|1.89|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.89|0.80|0.3502
70932307|NCT02307682|141364356|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-7.0|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.5|-7.0|
70932308|NCT02307682|141364356|OTHER||Difference in proportions|-5.9|||||TWO_SIDED|95.0|-11.4|-0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||-0.7|-11.4|
71106126|NCT01576783|141718888|OTHER|The reported p-value is for the comparison of the change in Arachidonic acid (20:4n-6) mol% between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|2.2|||<|0.001|TWO_SIDED|95.0|1.7|2.8||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||2.8|1.7|<0.001
70932309|NCT02307682|141364356|OTHER||Difference in proportions|-6.1|||||TWO_SIDED|95.0|-11.8|-0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||-0.1|-11.8|
71019876|NCT01236053|141546934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.4654|TWO_SIDED|95.0|0.76|1.81|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.81|0.76|0.4654
71019877|NCT01236053|141546934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.3987|TWO_SIDED|95.0|0.59|1.23|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.23|0.59|0.3987
71106127|NCT01576783|141718888|OTHER|The reported p-value is for the comparison of the change in Total n-6 mol% between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|0.4||||0.61|TWO_SIDED|95.0|-1.0|1.7||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||1.7|-1.0|0.61
70932310|NCT02307682|141364356|OTHER||Difference in proportions|-11.7|||||TWO_SIDED|95.0|-17.0|-6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||-6.4|-17.0|
70932311|NCT02307682|141364356|OTHER||Difference in proportions|-5.1|||||TWO_SIDED|95.0|-10.1|0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||0.1|-10.1|
71019878|NCT01236053|141546934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.3349|TWO_SIDED|95.0|0.58|1.2|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.20|0.58|0.3349
71019879|NCT01236053|141546934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.0827|TWO_SIDED|95.0|0.96|1.98|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.98|0.96|0.0827
71019880|NCT01236053|141546934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.0932|TWO_SIDED|95.0|0.95|1.96|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.96|0.95|0.0932
71019881|NCT01236053|141546934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.013|TWO_SIDED|95.0|1.07|1.8|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.80|1.07|0.0130
71019882|NCT01236053|141546934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.0241|TWO_SIDED|95.0|1.04|1.75|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.75|1.04|0.0241
71019883|NCT01236053|141546935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.5043|TWO_SIDED|95.0|0.77|1.68|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.68|0.77|0.5043
71106128|NCT01576783|141718888|OTHER|The reported p-value is for the comparison of the change in α-linolenic acid (18:3n-3) between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|0.0||||0.4|TWO_SIDED|95.0|-0.1|0.1||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||0.1|-0.1|0.40
71106129|NCT01576783|141718888|OTHER|The reported p-value is for the comparison of the change in Eicosapentaenoic acid (20:5n-3) between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|0.0||||0.12|TWO_SIDED|95.0|0.0|0.1||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||0.1|0.0|0.12
71106130|NCT01576783|141718888|OTHER|The reported p-value is for the comparison of the change in Docosapentaenoic acid (22:5n-3) between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.1|0.0||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||0.0|-0.1|<0.001
71106131|NCT01576783|141718888|OTHER|The reported p-value is for the comparison of the change in Docosahexaenoic acid (22:6n-3) between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|1.2|||<|0.001|TWO_SIDED|95.0|1.0|1.5||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||1.5|1.0|<0.001
71106132|NCT01576783|141718888|OTHER|The reported p-value is for the comparison of the change in Total n-3 between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|1.2|||<|0.001|TWO_SIDED|95.0|0.9|1.4||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||1.4|0.9|<0.001
71106133|NCT01576783|141718889|OTHER|The reported p-value is for the comparison of the change in n-6:n-3 ratio between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|-4.6|||<|0.001|TWO_SIDED|95.0|-5.5|-3.7||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||-3.7|-5.5|<0.001
71019884|NCT01236053|141546935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.7129|TWO_SIDED|95.0|0.73|1.59|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.59|0.73|0.7129
71019885|NCT01236053|141546935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.2055|TWO_SIDED|95.0|0.91|1.57|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.57|0.91|0.2055
71019886|NCT01236053|141546935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.3005|TWO_SIDED|95.0|0.88|1.52|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.52|0.88|0.3005
70851275|NCT00669409|141190535|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.6|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-28.0|4.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.8|-28.0|
71019887|NCT01236053|141546935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.2849|TWO_SIDED|95.0|0.84|1.77|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.77|0.84|0.2849
70851276|NCT00669409|141190535|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-30.1|13.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.5|-30.1|
71019888|NCT01236053|141546935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.365|TWO_SIDED|95.0|0.82|1.72|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.72|0.82|0.3650
71019889|NCT01236053|141546935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.7559|TWO_SIDED|95.0|0.78|1.4|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.40|0.78|0.7559
71019890|NCT01236053|141546935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.852|TWO_SIDED|95.0|0.77|1.37|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.37|0.77|0.8520
71019891|NCT01236053|141546935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.0459|TWO_SIDED|95.0|1.01|2.06|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.06|1.01|0.0459
71019892|NCT01236053|141546935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.0542|TWO_SIDED|95.0|0.99|2.04|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||2.04|0.99|0.0542
71019893|NCT01236053|141546935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.0312|TWO_SIDED|95.0|1.03|1.74|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.74|1.03|0.0312
71019894|NCT01236053|141546935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.0508|TWO_SIDED|95.0|1.0|1.7|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.70|1.00|0.0508
71019895|NCT01236053|141546936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.0892|TWO_SIDED|95.0|0.94|2.42|||Conditional Logistic Regression||"Comparison: \> 1 year (with 2 year lag) and Never (with 2 year lag)."|||2.42|0.94|0.0892
70851277|NCT00669409|141190536|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-20.6|12.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.8|-20.6|
71019896|NCT01236053|141546936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.1043|TWO_SIDED|95.0|0.92|2.39|||Conditional Logistic Regression||"Comparison: \> 1 year (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||2.39|0.92|0.1043
71019897|NCT01236053|141546936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.0101|TWO_SIDED|95.0|1.1|2.06|||Conditional Logistic Regression||"Comparison: \> 1 year (without 2 year lag) and Never (without 2 year lag)."|||2.06|1.10|0.0101
71019898|NCT01236053|141546936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.0186|TWO_SIDED|95.0|1.07|2.0|||Conditional Logistic Regression||"Comparison: \> 1 year (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||2.00|1.07|0.0186
71019899|NCT01236053|141546936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.69||||0.1458|TWO_SIDED|95.0|0.83|3.43|||Conditional Logistic Regression||"Comparison: \> 2 years (with 2 year lag) and Never (with 2 year lag)."|||3.43|0.83|0.1458
71019900|NCT01236053|141546936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.1859|TWO_SIDED|95.0|0.79|3.29|||Conditional Logistic Regression||"Comparison: \> 2 years (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||3.29|0.79|0.1859
71019901|NCT01236053|141546936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.0122|TWO_SIDED|95.0|1.13|2.72|||Conditional Logistic Regression||"Comparison: \> 2 years (without 2 year lag) and Never (without 2 year lag)."|||2.72|1.13|0.0122
71019902|NCT01236053|141546936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72||||0.0162|TWO_SIDED|95.0|1.1|2.67|||Conditional Logistic Regression||"Comparison: \> 2 years (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||2.67|1.10|0.0162
71019903|NCT01236053|141546936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.7573|TWO_SIDED|95.0|0.19|3.36|||Conditional Logistic Regression||"Comparison: \> 3 years (with 2 year lag) and Never (with 2 year lag)."|||3.36|0.19|0.7573
71019904|NCT01236053|141546936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.7088|TWO_SIDED|95.0|0.18|3.21|||Conditional Logistic Regression||"Comparison: \> 3 years (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||3.21|0.18|0.7088
71019905|NCT01236053|141546936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.0787|TWO_SIDED|95.0|0.93|3.64|||Conditional Logistic Regression||"Comparison: \> 3 years (without 2 year lag) and Never (without 2 year lag)."|||3.64|0.93|0.0787
70851278|NCT00669409|141190536|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.0|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-35.6|-2.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.3|-35.6|
70851279|NCT00669409|141190536|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-19.6|13.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.7|-19.6|
71106134|NCT01576783|141718892|OTHER|The reported p-value is for the comparison of the change in Effortful Control Composite scores between groups (DHA+AA vs. Placebo).||||||0.13||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||||||.13
71106135|NCT01576783|141718892|OTHER|The reported p-value is for the comparison of the change in Activity Level Composite scores between groups (DHA+AA vs. Placebo).||||||0.76||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||||||.76
71106136|NCT01576783|141718893|OTHER|The reported p-value is for the comparison of the change in Cognitive Composite scores between groups (DHA+AA vs. Placebo).||||||0.66||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||A sample of 448 was planned to achieve \>80% power to detect a 4.2-point difference (0.27-standard deviation (SD)) in Bayley-III cognitive composite scores with 10% loss to follow-up.The investigational product manufacturer discontinued production once 377 were enrolled, thereby capping enrollment. That sample provided 80% power to detect a 0.29-SD difference in Bayley-III scores.||||.66
71106137|NCT01576783|141718893|OTHER|The reported p-value is for the comparison of the change in Language Composite scores between groups (DHA+AA vs. Placebo).||||||0.55||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||A sample of 448 was planned to achieve \>80% power to detect a 4.2-point difference (0.27-standard deviation (SD)) in Bayley-III cognitive composite scores with 10% loss to follow-up.The investigational product manufacturer discontinued production once 377 were enrolled, thereby capping enrollment. That sample provided 80% power to detect a 0.29-SD difference in Bayley-III scores.||||.55
71106138|NCT01576783|141718893|OTHER|The reported p-value is for the comparison of the change in Motor Composite scores between groups (DHA+AA vs. Placebo).||||||0.88||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||A sample of 448 was planned to achieve \>80% power to detect a 4.2-point difference (0.27-standard deviation (SD)) in Bayley-III cognitive composite scores with 10% loss to follow-up.The investigational product manufacturer discontinued production once 377 were enrolled, thereby capping enrollment. That sample provided 80% power to detect a 0.29-SD difference in Bayley-III scores.||||.88
71106139|NCT01576783|141718894|OTHER|The reported p-value is for the comparison of the change in Nocturnal Sleep Duration between groups (DHA+AA vs. Placebo).||||||0.11||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||||||.11
71106140|NCT01576783|141718894|OTHER|The reported p-value is for the comparison of the change in daytime sleep duration between groups (DHA+AA vs. Placebo).||||||0.47||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||||||0.47
70851280|NCT00669409|141190536|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.5|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-30.9|1.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.9|-30.9|
71019906|NCT01236053|141546936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.0873|TWO_SIDED|95.0|0.92|3.58|||Conditional Logistic Regression||"Comparison: \> 3 years (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||3.58|0.92|0.0873
71019907|NCT01236053|141546937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.4233|TWO_SIDED|95.0|0.8|1.7|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.70|0.80|0.4233
71019908|NCT01236053|141546937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.5908|TWO_SIDED|95.0|0.76|1.62|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.62|0.76|0.5908
71019909|NCT01236053|141546937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.054|TWO_SIDED|95.0|1.0|1.67|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.67|1.00|0.0540
71019910|NCT01236053|141546937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.0939|TWO_SIDED|95.0|0.96|1.62|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.62|0.96|0.0939
71106141|NCT01576783|141718894|OTHER|The reported p-value is for the comparison of the change in total sleep duration between groups (DHA+AA vs. Placebo).||||||0.32||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||||||0.32
70851281|NCT00669409|141190536|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-29.4|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-51.2|-7.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-7.6|-51.2|
71019911|NCT01236053|141546937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.214|TWO_SIDED|95.0|0.87|1.87|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.87|0.87|0.2140
71019912|NCT01236053|141546937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.294|TWO_SIDED|95.0|0.84|1.8|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.80|0.84|0.2940
71019913|NCT01236053|141546937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.8352|TWO_SIDED|95.0|0.71|1.32|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.32|0.71|0.8352
71019914|NCT01236053|141546937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.7809|TWO_SIDED|95.0|0.7|1.31|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.31|0.70|0.7809
71019915|NCT01236053|141546937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.0921|TWO_SIDED|95.0|0.95|1.94|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.94|0.95|0.0921
71019916|NCT01236053|141546937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.1091|TWO_SIDED|95.0|0.94|1.92|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.92|0.94|0.1091
71019917|NCT01236053|141546937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.0564|TWO_SIDED|95.0|0.99|1.68|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.68|0.99|0.0564
71106142|NCT01576783|141718895|OTHER|The reported p-value is for the comparison of the change in weight-for-age z scores between groups (DHA+AA vs. Placebo).||||||0.99||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.||||||0.99
71106143|NCT01576783|141718895|OTHER|The reported p-value is for the comparison of the change in length-for-age z scores between groups (DHA+AA vs. Placebo).||||||0.27||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.||||||0.27
71106144|NCT01576783|141718895|OTHER|The reported p-value is for the comparison of the change in head circumference-for-age z scores between groups (DHA+AA vs. Placebo).||||||0.39||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.||||||0.39
71106145|NCT01576783|141718895|OTHER|The reported p-value is for the comparison of the change in mid upper arm circumference-for-age z scores between groups (DHA+AA vs. Placebo).||||||0.25||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.||||||0.25
71106146|NCT01576783|141718895|OTHER|The reported p-value is for the comparison of the change in triceps skinfold-for-age z scores between groups (DHA+AA vs. Placebo).||||||0.85||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.||||||0.85
71106147|NCT01576783|141718895|OTHER|The reported p-value is for the comparison of the change in subscapular skinfold-for-age z scores between groups (DHA+AA vs. Placebo).||||||0.82||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.||||||0.82
71019918|NCT01236053|141546937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.0939|TWO_SIDED|95.0|0.96|1.63|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.63|0.96|0.0939
71019919|NCT01236053|141546938|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.58||||0.3082|TWO_SIDED|95.0|0.31|41.71|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||41.71|0.31|0.3082
71106148|NCT01576783|141718896|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.42||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.42
71106149|NCT01576783|141718896|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.68||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.68
71106150|NCT01576783|141718896|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.78||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.78
71106151|NCT01576783|141718896|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.32||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.32
71106152|NCT01576783|141718896|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.97||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.97
71106153|NCT01576783|141718896|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.62||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.62
71106154|NCT01576783|141718896|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.69||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.69
71106155|NCT01576783|141718897|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.22||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.22
71019920|NCT01236053|141546938|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9||||0.3999|TWO_SIDED|95.0|0.24|34.69|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||34.69|0.24|0.3999
70932312|NCT02307682|141364356|OTHER||Difference in proportions|-5.1|||||TWO_SIDED|95.0|-10.0|0.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||-0.0|-10.0|
70932313|NCT02307682|141364356|OTHER||Difference in proportions|-5.7|||||TWO_SIDED|95.0|-11.7|0.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||0.5|-11.7|
70932314|NCT02307682|141364356|OTHER||Difference in proportions|-11.7|||||TWO_SIDED|95.0|-17.3|-6.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||-6.3|-17.3|
70932315|NCT02307682|141364356|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-4.0|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||6.5|-4.0|
70932316|NCT02307682|141364356|OTHER||Difference in proportions|-5.0|||||TWO_SIDED|95.0|-9.7|-0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||-0.3|-9.7|
71019921|NCT01236053|141546938|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.7509|TWO_SIDED|95.0|0.16|12.52|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||12.52|0.16|0.7509
71019922|NCT01236053|141546938|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.6303|TWO_SIDED|95.0|0.18|17.07|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||17.07|0.18|0.6303
71019923|NCT01236053|141546939|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.32||||0.2038|TWO_SIDED|95.0|0.37|108.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||108.8|0.37|0.2038
71019924|NCT01236053|141546939|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.63||||0.2866|TWO_SIDED|95.0|0.28|77.51|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||77.51|0.28|0.2866
71019925|NCT01236053|141546939|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.32||||0.2038|TWO_SIDED|95.0|0.37|108.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||108.8|0.37|0.2038
71019926|NCT01236053|141546939|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.4||||0.1118|TWO_SIDED|95.0|0.5|839.0|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||839.0|0.50|0.1118
71019927|NCT01236053|141546940|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.32||||0.2038|TWO_SIDED|95.0|0.37|108.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||108.8|0.37|0.2038
71106156|NCT01576783|141718898|OTHER|The reported p-value is for the comparison of the change in Nocturnal Sleep Duration between groups (DHA+AA vs. Placebo).||||||0.23||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|||||||0.23
71106157|NCT01576783|141718898|OTHER|The reported p-value is for the comparison of the change in Daytime Sleep Duration between groups (DHA+AA vs. Placebo).||||||0.07||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|||||||0.07
70932317|NCT02307682|141364356|OTHER||Difference in proportions|-5.5|||||TWO_SIDED|95.0|-11.4|-0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||-0.1|-11.4|
71019928|NCT01236053|141546940|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.63||||0.2866|TWO_SIDED|95.0|0.28|77.51|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||77.51|0.28|0.2866
70932318|NCT02307682|141364356|OTHER||Difference in proportions|-11.1|||||TWO_SIDED|95.0|-16.4|-6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||-6.2|-16.4|
71019929|NCT01236053|141546940|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.32||||0.2038|TWO_SIDED|95.0|0.37|108.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||108.8|0.37|0.2038
71019930|NCT01236053|141546940|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.4||||0.1118|TWO_SIDED|95.0|0.5|839.0|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||839.0|0.50|0.1118
71019931|NCT01236053|141546942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.32||||0.2038|TWO_SIDED|95.0|0.37|108.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||108.8|0.37|0.2038
71019932|NCT01236053|141546942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.63||||0.2866|TWO_SIDED|95.0|0.28|77.51|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||77.51|0.28|0.2866
71019933|NCT01236053|141546942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.32||||0.2038|TWO_SIDED|95.0|0.37|108.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||108.8|0.37|0.2038
71019934|NCT01236053|141546942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.4||||0.1118|TWO_SIDED|95.0|0.5|839.0|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||839.0|0.5|0.1118
71019935|NCT01236053|141546943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.9614|TWO_SIDED|95.0|0.58|1.69|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||1.69|0.58|0.9614
71019936|NCT01236053|141546943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.5179|TWO_SIDED|95.0|0.49|1.44|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.44|0.49|0.5179
71052626|NCT03056157|141609804|SUPERIORITY||Slope|-0.26||||0.02|TWO_SIDED|95.0|-0.47|-0.05|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Justification scores, t(113) = -2.44, d = 0.46.||-0.05|-0.47|0.02
71052627|NCT03056157|141609804|SUPERIORITY||Slope|-0.06||||0.62|TWO_SIDED|95.0|-0.26|0.14|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Justification scores, t(113) = -0.69, d = 0.12.||0.14|-0.26|0.62
71052628|NCT03056157|141609804|SUPERIORITY||Slope|0.16||||0.18|TWO_SIDED|95.0|-0.07|0.39|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Justification scores, t(314) = 1.34, d = 0.15.||0.39|-0.07|0.18
71052629|NCT03056157|141609804|SUPERIORITY||Slope|0.13||||0.14|TWO_SIDED|95.0|-0.04|0.3|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Justification scores, t(113) = 1.49, d = 0.28.||0.30|-0.04|0.14
71052630|NCT03056157|141609804|SUPERIORITY||Slope|-0.03||||0.71|TWO_SIDED|95.0|-0.19|0.13|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Justification scores, t(113) = -0.38, d = 0.07.||0.13|-0.19|0.71
71052631|NCT03056157|141609805|SUPERIORITY||Slope|-0.47|||<|0.001|TWO_SIDED|95.0|-0.74|-0.2|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Hindsight-Bias scores, t(314) = -3.41, d = 0.39.||-0.20|-0.74|<0.001
71106158|NCT01576783|141718898|OTHER|The reported p-value is for the comparison of the change in Total Sleep Duration between groups (DHA+AA vs. Placebo).||||||0.06||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|||||||0.06
71019937|NCT01236053|141546943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.8856|TWO_SIDED|95.0|0.71|1.48|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||1.48|0.71|0.8856
71019938|NCT01236053|141546943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.5078|TWO_SIDED|95.0|0.61|1.28|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.28|0.61|0.5078
71052632|NCT03056157|141609805|SUPERIORITY||Slope|-0.64|||<|0.001|TWO_SIDED|95.0|-0.83|-0.44|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Hindsight-Bias scores, t(113) = -6.41, d = 1.20.||-0.44|-0.83|<0.001
71052633|NCT03056157|141609805|SUPERIORITY||Slope|-0.17||||0.07|TWO_SIDED|95.0|-0.36|0.02|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Hindsight-Bias scores, t(113) = -1.83, d = 0.34.||0.02|-0.36|0.07
71052634|NCT03056157|141609805|SUPERIORITY||Slope|0.35||||0.002|TWO_SIDED|95.0|0.13|0.57|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Hindsight-Bias scores, t(314) = 3.13, d = 0.06.||0.57|0.13|0.002
71052635|NCT03056157|141609805|SUPERIORITY||Slope|0.18||||0.03|TWO_SIDED|95.0|0.02|0.34|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Hindsight-Bias scores, t(113) = 2.21, d = 0.42.||0.34|0.02|0.03
71052636|NCT03056157|141609805|SUPERIORITY||Slope|-0.17||||0.03|TWO_SIDED|95.0|-0.32|-0.02|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Hindsight-Bias scores, t(113) = -2.22, d = 0.42.||-0.02|-0.32|0.03
71052637|NCT03056157|141609806|SUPERIORITY||Slope|0.32||||0.01|TWO_SIDED|95.0|0.06|0.57|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Wrongdoing scores, t(314) = 2.46, d = 0.28.||0.57|0.06|0.01
71106159|NCT01576783|141718899|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.51||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.51
71019939|NCT01236053|141546944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.6888|TWO_SIDED|95.0|0.36|1.95|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.95|0.36|0.6888
71052638|NCT03056157|141609806|SUPERIORITY||Slope|0.001||||0.95|TWO_SIDED|95.0|-0.17|0.18|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for RGI Wrongdoing scores, t(113) = 0.06, d = 0.01.||0.18|-0.17|0.95
71019940|NCT01236053|141546944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.5024|TWO_SIDED|95.0|0.32|1.75|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.75|0.32|0.5024
71019941|NCT01236053|141546944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.6164|TWO_SIDED|95.0|0.49|1.53|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.53|0.49|0.6164
71052639|NCT03056157|141609806|SUPERIORITY||Slope|-0.31||||0.01|TWO_SIDED|95.0|-0.5|-0.13|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for RGI Wrongdoing scores, t(113) = -3.32, d = 0.62.||-0.13|-0.50|0.01
71052640|NCT03056157|141609806|SUPERIORITY||Slope|-0.21||||0.04|TWO_SIDED|95.0|-0.41|-0.01|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Wrongdoing scores, t(314) = -2.02, d = 0.23.||-0.01|-0.41|0.04
71052641|NCT03056157|141609806|SUPERIORITY||Slope|-0.16||||0.03|TWO_SIDED|95.0|-0.3|-0.02|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Wrongdoing scores, t(113) = -2.18, d = 0.03.||-0.02|-0.30|0.03
71052642|NCT03056157|141609806|SUPERIORITY||Slope|0.05||||0.48|TWO_SIDED|95.0|-0.09|0.2|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for RGI Wrongdoing scores, t(113) = 0.70, d = 0.13.||0.20|-0.09|0.48
71019942|NCT01236053|141546944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.4002|TWO_SIDED|95.0|0.44|1.39|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.39|0.44|0.4002
71019943|NCT01236053|141546944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.7329|TWO_SIDED|95.0|0.25|2.66|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.66|0.25|0.7329
71019944|NCT01236053|141546944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.5731|TWO_SIDED|95.0|0.22|2.33|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.33|0.22|0.5731
71019945|NCT01236053|141546944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.3762|TWO_SIDED|95.0|0.69|2.63|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.63|0.69|0.3762
71019946|NCT01236053|141546944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.582|TWO_SIDED|95.0|0.62|2.36|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.36|0.62|0.5820
71019947|NCT01236053|141546944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.4782|TWO_SIDED|95.0|0.58|3.23|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||3.23|0.58|0.4782
71019948|NCT01236053|141546944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.8998|TWO_SIDED|95.0|0.44|2.52|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.52|0.44|0.8998
71106160|NCT01576783|141718900|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.09||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups. Model controlled for baseline scores.||||||0.09
70932319|NCT02307682|141364357|OTHER||Difference in proportions|-2.0|||||TWO_SIDED|95.0|-7.9|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.6|-7.9|
71019949|NCT01236053|141546944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.9308|TWO_SIDED|95.0|0.53|1.99|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.99|0.53|0.9308
71019950|NCT01236053|141546944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.5125|TWO_SIDED|95.0|0.41|1.56|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.56|0.41|0.5125
71019951|NCT01236053|141546945|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.8655|TWO_SIDED|95.0|0.37|2.33|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||2.33|0.37|0.8655
71019952|NCT01236053|141546945|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.6482|TWO_SIDED|95.0|0.32|2.05|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.05|0.32|0.6482
71019953|NCT01236053|141546945|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.9003|TWO_SIDED|95.0|0.53|1.76|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.76|0.53|0.9003
71019954|NCT01236053|141546945|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.6|TWO_SIDED|95.0|0.46|1.56|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.56|0.46|0.6000
71019955|NCT01236053|141546945|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.567|TWO_SIDED|95.0|0.27|2.06|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.06|0.27|0.5670
71019956|NCT01236053|141546945|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.4353|TWO_SIDED|95.0|0.24|1.85|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.85|0.24|0.4353
71019957|NCT01236053|141546945|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.8922|TWO_SIDED|95.0|0.56|1.95|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.95|0.56|0.8922
71052643|NCT03056157|141609807|SUPERIORITY||Slope|0.7||||0.45|TWO_SIDED|95.0|-1.12|2.52|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRSI scores, t(317) = 0.76, d = 0.09.||2.52|-1.12|0.45
71052644|NCT03056157|141609807|SUPERIORITY||Slope|-1.2||||0.08|TWO_SIDED|95.0|-2.52|0.12|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRSI scores, t(113) = -1.79, d = 0.34.||0.12|-2.52|0.08
71052645|NCT03056157|141609807|SUPERIORITY||Slope|-1.91||||0.003|TWO_SIDED|95.0|-3.15|-0.66|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRSI scores, t(113) = -3.00, d = 0.56.||-0.66|-3.15|0.003
71019958|NCT01236053|141546945|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.8591|TWO_SIDED|95.0|0.5|1.77|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.77|0.50|0.8591
71019959|NCT01236053|141546945|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.4779|TWO_SIDED|95.0|0.58|3.23|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||3.23|0.58|0.4779
71019960|NCT01236053|141546945|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.8994|TWO_SIDED|95.0|0.44|2.52|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.52|0.44|0.8994
71019961|NCT01236053|141546945|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.78|TWO_SIDED|95.0|0.57|2.12|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.12|0.57|0.7800
71052646|NCT03056157|141609807|SUPERIORITY||standardized effect size of the slope|-0.29||||0.7|TWO_SIDED|95.0|-1.75|1.17|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRSI scores, t(317) = -0.39, d = 0.04.||1.17|-1.75|0.70
71106161|NCT01576783|141718901|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.29||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups. Model controlled for baseline scores.||||||0.29
71106162|NCT01576783|141718901|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.11||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups. Model controlled for baseline scores.||||||0.11
71106163|NCT01576783|141718901|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.23||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.23
71106164|NCT01576783|141718901|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.29||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.29
71106165|NCT01576783|141718901|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.06||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.06
71019962|NCT01236053|141546945|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.6577|TWO_SIDED|95.0|0.44|1.67|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.67|0.44|0.6577
71019963|NCT01236053|141546947|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.8111|TWO_SIDED|95.0|0.48|2.59|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||2.59|0.48|0.8111
71019964|NCT01236053|141546947|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.9104|TWO_SIDED|95.0|0.45|2.46|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.46|0.45|0.9104
71019965|NCT01236053|141546947|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.5592|TWO_SIDED|95.0|0.68|2.07|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||2.07|0.68|0.5592
71019966|NCT01236053|141546947|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.8521|TWO_SIDED|95.0|0.6|1.85|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.85|0.60|0.8521
71019967|NCT01236053|141546947|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.5529|TWO_SIDED|95.0|0.26|2.04|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.04|0.26|0.5529
71019968|NCT01236053|141546947|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.6||||0.3275|TWO_SIDED|95.0|0.21|1.68|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.68|0.21|0.3275
71019969|NCT01236053|141546947|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.73|TWO_SIDED|95.0|0.46|1.72|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.72|0.46|0.7300
71019970|NCT01236053|141546947|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.4831|TWO_SIDED|95.0|0.41|1.53|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.53|0.41|0.4831
71019971|NCT01236053|141546947|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.7693|TWO_SIDED|95.0|0.45|2.92|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.92|0.45|0.7693
71019972|NCT01236053|141546947|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.8189|TWO_SIDED|95.0|0.35|2.3|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.30|0.35|0.8189
71019973|NCT01236053|141546947|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.98|TWO_SIDED|95.0|0.5|1.98|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.98|0.50|0.9800
71019974|NCT01236053|141546947|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.4944|TWO_SIDED|95.0|0.39|1.58|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.58|0.39|0.4944
71019975|NCT01236053|141546948|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.0||||0.0144|TWO_SIDED|95.0|1.81|220.5|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||220.5|1.81|0.0144
71019976|NCT01236053|141546948|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.79||||0.0743|TWO_SIDED|95.0|0.79|147.0|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||147.0|0.79|0.0743
71019977|NCT01236053|141546949|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|10.0||||0.1035|TWO_SIDED|95.0|0.63|159.9|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||159.9|0.63|0.1035
71019978|NCT01236053|141546949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1||||0.3799|TWO_SIDED|95.0|0.18|95.82|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||95.82|0.18|0.3799
71019979|NCT01236053|141546950|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.0||||0.1035|TWO_SIDED|95.0|0.63|159.9|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||159.9|0.63|0.1035
70932320|NCT02307682|141364357|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-4.1|7.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||7.4|-4.1|
71019980|NCT01236053|141546950|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1||||0.3799|TWO_SIDED|95.0|0.18|95.82|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||95.82|0.18|0.3799
70932321|NCT02307682|141364357|OTHER||Difference in proportions|-4.5|||||TWO_SIDED|95.0|-10.0|1.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.3|-10.0|
70932322|NCT02307682|141364357|OTHER||Difference in proportions|-1.5|||||TWO_SIDED|95.0|-7.7|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||4.5|-7.7|
71019981|NCT01236053|141546952|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.0||||0.1035|TWO_SIDED|95.0|0.63|159.9|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||159.9|0.63|0.1035
71019982|NCT01236053|141546952|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1||||0.3799|TWO_SIDED|95.0|0.18|95.82|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||95.82|0.18|0.3799
71019983|NCT01236053|141546953|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01||||0.0066|TWO_SIDED|95.0|1.21|3.32|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||3.32|1.21|0.0066
71019984|NCT01236053|141546953|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.0494|TWO_SIDED|95.0|1.0|2.82|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.82|1.00|0.0494
70932323|NCT02307682|141364357|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-7.6|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.3|-7.6|
70932324|NCT02307682|141364357|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-5.4|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||5.8|-5.4|
70932325|NCT02307682|141364357|OTHER||Difference in proportions|-2.5|||||TWO_SIDED|95.0|-8.3|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||3.6|-8.3|
71019985|NCT01236053|141546953|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93||||0.0006|TWO_SIDED|95.0|1.33|2.82|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||2.82|1.33|0.0006
71052647|NCT03056157|141609807|SUPERIORITY||Slope|-0.59||||0.27|TWO_SIDED|95.0|-1.64|0.46|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRSI scores, t(317) = -1.11, d = 0.12.||0.46|-1.64|0.27
70932326|NCT02307682|141364357|OTHER||Difference in proportions|-4.3|||||TWO_SIDED|95.0|-10.0|1.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||1.9|-10.0|
71019986|NCT01236053|141546953|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63||||0.0138|TWO_SIDED|95.0|1.11|2.41|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.41|1.11|0.0138
71019987|NCT01236053|141546954|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.29||||0.0006|TWO_SIDED|95.0|1.66|6.53|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||6.53|1.66|0.0006
71019988|NCT01236053|141546954|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.01||||0.002|TWO_SIDED|95.0|1.5|6.05|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||6.05|1.50|0.0020
71019989|NCT01236053|141546954|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.49||||0.0013|TWO_SIDED|95.0|1.43|4.34|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||4.34|1.43|0.0013
71019990|NCT01236053|141546954|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.16||||0.008|TWO_SIDED|95.0|1.22|3.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||3.80|1.22|0.0080
71019991|NCT01236053|141546954|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.8165|TWO_SIDED|95.0|0.2|3.61|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||3.61|0.20|0.8165
71052648|NCT03056157|141609807|SUPERIORITY||Slope|-0.29||||0.57|TWO_SIDED|95.0|-1.32|0.72|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRSI scores, t(317) = -0.57, d = 0.06.||0.72|-1.32|0.57
71052649|NCT03056157|141609808|SUPERIORITY||Slope|3.41||||0.02|TWO_SIDED|95.0|0.56|6.25|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SOS-10 scores, t(326) = 2.35, d = 0.26.||6.25|0.56|0.02
71052650|NCT03056157|141609808|SUPERIORITY||Slope|6.84|||<|0.001|TWO_SIDED|95.0|4.78|8.9|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SOS-10 scores, t(116) = -6.53, d = 1.21.||8.90|4.78|<0.001
70851282|NCT00669409|141190537|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-16.3|17.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.1|-16.3|
71019992|NCT01236053|141546954|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.6624|TWO_SIDED|95.0|0.17|3.12|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||3.12|0.17|0.6624
71019993|NCT01236053|141546954|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.6316|TWO_SIDED|95.0|0.45|3.68|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.68|0.45|0.6316
71019994|NCT01236053|141546954|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.906|TWO_SIDED|95.0|0.35|3.22|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||3.22|0.35|0.9060
71019995|NCT01236053|141546954|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.3731|TWO_SIDED|95.0|0.61|3.74|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||3.74|0.61|0.3731
71019996|NCT01236053|141546954|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.8266|TWO_SIDED|95.0|0.43|2.87|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.87|0.43|0.8266
71019997|NCT01236053|141546954|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.0712|TWO_SIDED|95.0|0.95|3.13|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||3.13|0.95|0.0712
71019998|NCT01236053|141546954|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.2674|TWO_SIDED|95.0|0.77|2.6|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.60|0.77|0.2674
71019999|NCT01236053|141546955|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.61||||0.0005|TWO_SIDED|95.0|1.75|7.46|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||7.46|1.75|0.0005
71020000|NCT01236053|141546955|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.25||||0.0019|TWO_SIDED|95.0|1.55|6.83|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||6.83|1.55|0.0019
71020001|NCT01236053|141546955|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.51||||0.0024|TWO_SIDED|95.0|1.39|4.55|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||4.55|1.39|0.0024
71052651|NCT03056157|141609808|SUPERIORITY||Slope|3.43||||0.001|TWO_SIDED|95.0|1.47|5.4|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SOS-10 scores, t(116) = 3.44, d = 0.64.||5.40|1.47|0.001
71052652|NCT03056157|141609808|SUPERIORITY||Slope|0.76||||0.51|TWO_SIDED|95.0|-1.5|3.03|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SOS-10 scores, t(326) = 0.66, d = 0.07.||3.03|-1.50|0.51
71052653|NCT03056157|141609808|SUPERIORITY||Slope|-0.27||||0.75|TWO_SIDED|95.0|-1.89|1.35|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SOS-10 scores, t(326) = -0.32, d = 0.04.||1.35|-1.89|0.75
70851283|NCT00669409|141190537|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.8|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-35.4|-2.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.2|-35.4|
70851284|NCT00669409|141190537|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-24.1|9.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.1|-24.1|
71020002|NCT01236053|141546955|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.18||||0.0115|TWO_SIDED|95.0|1.19|4.0|||Wilcoxon (Mann-Whitney)||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||4.00|1.19|0.0115
71020003|NCT01236053|141546955|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.6281|TWO_SIDED|95.0|0.17|2.96|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.96|0.17|0.6281
71020004|NCT01236053|141546955|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61||||0.5103|TWO_SIDED|95.0|0.14|2.62|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.62|0.14|0.5103
71020005|NCT01236053|141546955|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.15||||0.7733|TWO_SIDED|95.0|0.45|2.9|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.90|0.45|0.7733
71020006|NCT01236053|141546955|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.837|TWO_SIDED|95.0|0.43|2.81|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.81|0.43|0.8370
71020007|NCT01236053|141546955|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.198|TWO_SIDED|95.0|0.75|4.1|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||4.10|0.75|0.1980
71020008|NCT01236053|141546955|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.5391|TWO_SIDED|95.0|0.54|3.21|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||3.21|0.54|0.5391
71052654|NCT03056157|141609808|SUPERIORITY||Slope|-1.03||||0.2|TWO_SIDED|95.0|-2.61|0.55|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SOS-10 scores, t(326) = -1.28, d = 0.14.||0.55|-2.61|0.20
71052655|NCT03056157|141609809|SUPERIORITY||Slope|0.26||||0.004|TWO_SIDED|95.0|0.08|0.43|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(319) = 2.93, d = 0.33.||0.43|0.08|0.004
71052656|NCT03056157|141609809|SUPERIORITY||Slope|0.35|||<|0.001|TWO_SIDED|95.0|0.23|0.48|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(114) = 5.56, d = 1.04.||0.48|0.23|<0.001
71020009|NCT01236053|141546955|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.97||||0.0224|TWO_SIDED|95.0|1.1|3.53|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||3.53|1.10|0.0224
71020010|NCT01236053|141546955|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.1815|TWO_SIDED|95.0|0.82|2.77|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.77|0.82|0.1815
71020011|NCT01236053|141546957|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38||||0.0248|TWO_SIDED|95.0|1.12|5.09|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||5.09|1.12|0.0248
71020012|NCT01236053|141546957|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.16||||0.052|TWO_SIDED|95.0|0.99|4.7|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||4.70|0.99|0.0520
71020013|NCT01236053|141546957|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.33||||0.0046|TWO_SIDED|95.0|1.3|4.2|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||4.20|1.30|0.0046
71020014|NCT01236053|141546957|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05||||0.0193|TWO_SIDED|95.0|1.12|3.72|||Wilcoxon (Mann-Whitney)||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||3.72|1.12|0.0193
71020015|NCT01236053|141546957|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.75||||0.0309|TWO_SIDED|95.0|1.1|6.88|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||6.88|1.10|0.0309
71020016|NCT01236053|141546957|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.11||||0.1285|TWO_SIDED|95.0|0.81|5.51|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||5.51|0.81|0.1285
71020017|NCT01236053|141546957|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.1257|TWO_SIDED|95.0|0.85|3.83|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.83|0.85|0.1257
71020018|NCT01236053|141546957|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.2944|TWO_SIDED|95.0|0.7|3.31|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||3.31|0.70|0.2944
71020019|NCT01236053|141546957|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.7032|TWO_SIDED|95.0|0.45|3.21|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||3.21|0.45|0.7032
71020020|NCT01236053|141546957|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.9922|TWO_SIDED|95.0|0.37|2.69|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.69|0.37|0.9922
71020021|NCT01236053|141546957|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.1227|TWO_SIDED|95.0|0.87|3.16|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||3.16|0.87|0.1227
71106166|NCT01576783|141718901|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.14||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.14
71020022|NCT01236053|141546957|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.3809|TWO_SIDED|95.0|0.69|2.61|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.61|0.69|0.3809
71020023|NCT01236053|141546958|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.1757|TWO_SIDED|95.0|0.8|3.34|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||3.34|0.80|0.1757
71020024|NCT01236053|141546958|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.4405|TWO_SIDED|95.0|0.64|2.75|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||2.75|0.64|0.4405
71020025|NCT01236053|141546958|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.442|TWO_SIDED|95.0|0.71|2.16|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||2.16|0.71|0.4420
71020026|NCT01236053|141546958|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.9034|TWO_SIDED|95.0|0.59|1.82|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||1.82|0.59|0.9034
71020027|NCT01236053|141546959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.2395|TWO_SIDED|95.0|0.65|5.6|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||5.60|0.65|0.2395
71020028|NCT01236053|141546959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.3764|TWO_SIDED|95.0|0.55|4.93|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||4.93|0.55|0.3764
71020029|NCT01236053|141546959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.7599|TWO_SIDED|95.0|0.48|2.71|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||2.71|0.48|0.7599
71020030|NCT01236053|141546959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.9502|TWO_SIDED|95.0|0.43|2.46|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||2.46|0.43|0.9502
71020031|NCT01236053|141546959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.7164|TWO_SIDED|95.0|0.3|5.75|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||5.75|0.30|0.7164
71106167|NCT01576783|141718901|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.13||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.13
71106168|NCT01576783|141718901|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.16||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.16
71106169|NCT01576783|141718902|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.98|||||||Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.98
71106170|NCT01576783|141718902|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.67||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.67
70851285|NCT00669409|141190537|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.5|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-31.9|0.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.9|-31.9|
70851286|NCT00669409|141190537|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-31.3|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-53.1|-9.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-9.5|-53.1|
70851287|NCT00669409|141190538|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-16.9|16.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.5|-16.9|
70851288|NCT00669409|141190538|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-20.0|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-36.7|-3.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.4|-36.7|
70851289|NCT00669409|141190538|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-24.2|9.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.0|-24.2|
70851290|NCT00669409|141190538|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.4|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-29.8|3.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.0|-29.8|
71020032|NCT01236053|141546959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.9345|TWO_SIDED|95.0|0.24|4.73|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||4.73|0.24|0.9345
70851291|NCT00669409|141190538|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-33.8|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-55.6|-12.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-12.0|-55.6|
70851292|NCT00669409|141190539|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-12.9|20.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.4|-12.9|
70851293|NCT00669409|141190539|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.9|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-36.5|-3.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.3|-36.5|
71020033|NCT01236053|141546959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.8833|TWO_SIDED|95.0|0.28|3.02|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.02|0.28|0.8833
71020034|NCT01236053|141546959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.6178|TWO_SIDED|95.0|0.22|2.46|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||2.46|0.22|0.6178
71020035|NCT01236053|141546959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.4556|TWO_SIDED|95.0|0.46|5.53|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||5.53|0.46|0.4556
71020036|NCT01236053|141546959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.7478|TWO_SIDED|95.0|0.35|4.29|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||4.29|0.35|0.7478
71020037|NCT01236053|141546959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.235|TWO_SIDED|95.0|0.71|4.13|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||4.13|0.71|0.2350
71020038|NCT01236053|141546959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.5428|TWO_SIDED|95.0|0.54|3.24|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.24|0.54|0.5428
71020039|NCT01236053|141546960|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9||||0.3123|TWO_SIDED|95.0|0.55|6.59|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||6.59|0.55|0.3123
71020040|NCT01236053|141546960|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.3951|TWO_SIDED|95.0|0.49|6.15|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||6.15|0.49|0.3951
71052657|NCT03056157|141609809|SUPERIORITY||Slope|0.1||||0.11|TWO_SIDED|95.0|-0.02|0.22|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(114) = 1.61, d = 0.30.||0.22|-0.02|0.11
71052658|NCT03056157|141609809|SUPERIORITY||Slope|0.007||||0.92|TWO_SIDED|95.0|-0.13|0.15|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(319) = 0.10, d = 0.10.||0.15|-0.13|0.92
71052659|NCT03056157|141609809|SUPERIORITY||Slope|0.02||||0.75|TWO_SIDED|95.0|-0.08|0.12|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(319) = 0.31, d = 0.03.||0.12|-0.08|0.75
71052660|NCT03056157|141609809|SUPERIORITY||Slope|0.01||||0.86|TWO_SIDED|95.0|-0.09|0.11|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(319) = 0.18, d = 0.02.||0.11|-0.09|0.86
71020041|NCT01236053|141546960|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.4388|TWO_SIDED|95.0|0.56|3.75|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||3.75|0.56|0.4388
71020042|NCT01236053|141546960|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.5535|TWO_SIDED|95.0|0.51|3.47|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.47|0.51|0.5535
71020043|NCT01236053|141546960|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.6332|TWO_SIDED|95.0|0.4|4.48|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||4.48|0.40|0.6332
71020044|NCT01236053|141546960|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.8743|TWO_SIDED|95.0|0.32|3.75|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.75|0.32|0.8743
71020045|NCT01236053|141546960|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.6132|TWO_SIDED|95.0|0.27|2.15|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.15|0.27|0.6132
71020046|NCT01236053|141546960|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.63||||0.3821|TWO_SIDED|95.0|0.22|1.78|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||1.78|0.22|0.3821
71020047|NCT01236053|141546960|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.3591|TWO_SIDED|95.0|0.51|6.28|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||6.28|0.51|0.3591
71020048|NCT01236053|141546960|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.6899|TWO_SIDED|95.0|0.37|4.58|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||4.58|0.37|0.6899
71020049|NCT01236053|141546960|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.78||||0.2031|TWO_SIDED|95.0|0.73|4.3|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||4.30|0.73|0.2031
71020050|NCT01236053|141546960|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.4932|TWO_SIDED|95.0|0.56|3.37|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.37|0.56|0.4932
71020051|NCT01236053|141546962|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.64||||0.0843|TWO_SIDED|95.0|0.88|7.96|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||7.96|0.88|0.0843
71020052|NCT01236053|141546962|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.71||||0.081|TWO_SIDED|95.0|0.88|8.28|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||8.28|0.88|0.0810
71020053|NCT01236053|141546962|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43||||0.4583|TWO_SIDED|95.0|0.55|3.7|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||3.70|0.55|0.4583
71020054|NCT01236053|141546962|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43||||0.4622|TWO_SIDED|95.0|0.55|3.73|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.73|0.55|0.4622
71020055|NCT01236053|141546962|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.5512|TWO_SIDED|95.0|0.43|4.95|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||4.95|0.43|0.5512
71052661|NCT03056157|141609810|SUPERIORITY||Slope|-2.56||||0.15|TWO_SIDED|95.0|-6.1|0.97|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DAR scores, t(325) = -1.43, d = 0.16.||0.97|-6.10|0.15
71052662|NCT03056157|141609810|SUPERIORITY||Slope|-5.28|||<|0.001|TWO_SIDED|95.0|-7.83|-2.73|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DAR scores, t(116) = -4.07, d = 0.76||-2.73|-7.83|<0.001
71052663|NCT03056157|141609810|SUPERIORITY||Slope|-2.71||||0.03|TWO_SIDED|95.0|-5.16|-0.28|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DAR scores, t(116) = -2.19, d = 0.41.||-0.28|-5.16|0.03
71052664|NCT03056157|141609810|SUPERIORITY||Slope|-1.38||||0.33|TWO_SIDED|95.0|-4.17|1.42|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DAR scores, t(325) = -0.97, d = 0.11.||1.42|-4.17|0.33
71052665|NCT03056157|141609810|SUPERIORITY||Slope|-1.54||||0.13|TWO_SIDED|95.0|-3.54|0.46|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DAR scores, t(325) = -1.51, d = 0.17.||0.46|-3.54|0.13
71052666|NCT03056157|141609810|SUPERIORITY||Slope|-0.17||||0.87|TWO_SIDED|95.0|-2.12|1.79|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DAR scores, t(325) = -0.17, d = 0.02.||1.79|-2.12|0.87
71020056|NCT01236053|141546962|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.9277|TWO_SIDED|95.0|0.31|3.67|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.67|0.31|0.9277
71020057|NCT01236053|141546962|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.6402|TWO_SIDED|95.0|0.51|2.95|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.95|0.51|0.6402
71020058|NCT01236053|141546962|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.9256|TWO_SIDED|95.0|0.4|2.32|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||2.32|0.40|0.9256
71020059|NCT01236053|141546962|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.9514|TWO_SIDED|95.0|0.24|4.5|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||4.50|0.24|0.9514
71020060|NCT01236053|141546962|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.7543|TWO_SIDED|95.0|0.18|3.44|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.44|0.18|0.7543
71020061|NCT01236053|141546962|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.8781|TWO_SIDED|95.0|0.38|3.07|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||3.07|0.38|0.8781
71020062|NCT01236053|141546962|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.7429|TWO_SIDED|95.0|0.29|2.4|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||2.40|0.29|0.7429
71020063|NCT01311505|141546964|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|98.9|||||TWO_SIDED|90.0|92.98|105.2||||||20 participants (10 per sequence) provided at least 98% power that 90% confidence interval (CI) for ratio of test to reference for AUC(0-t) of rifampicin lie within acceptance region of 80%-125%. Intra-participant coefficient of variation (CV) estimate of approximately 13.48% for AUC(0-t) was used for this power calculation. Natural log transformed AUC(0-t) was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as random effect.||105.20|92.98|
71020064|NCT01311505|141546965|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|98.24|||||TWO_SIDED|90.0|87.77|109.97||||||20 participants (10 per sequence) provided at least 94% power that 90% CI for ratio of test to reference for Cmax of rifampicin lie within acceptance region of 80%-125%. Intra-participant CV estimate of approximately 16.43% for Cmax was used for this power calculation. Natural log transformed Cmax was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as random effect.||109.97|87.77|
71020065|NCT01311505|141546967|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|100.25|||||TWO_SIDED|90.0|94.44|106.41||||||Natural log transformed AUC(0-∞) of rifampicin was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||106.41|94.44|
71020066|NCT00759759|141546996|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|90.46||||||90.0|82.9|98.7|||ANOVA|||ANOVA of ln-transformed plasma morphine Cmax||98.7|82.9|
71020067|NCT00759759|141546998|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA performed on the ratio of geometric means|mean ratio|101.1||||||90.0|96.9|105.4|||ANOVA|||Statistical analysis of ln-transformed plasma morphine AUClast||105.4|96.9|
71020068|NCT00759759|141546999|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|101.3||||||90.0|96.2|106.7|||ANOVA|||||106.7|96.2|
71020069|NCT00301873|141547011|SUPERIORITY_OR_OTHER||Slope|-0.107|STANDARD_ERROR_OF_MEAN|0.0855||0.2212||95.0||||The p-value is a test of whether the slope of the regression line is non-zero.|Regression, Linear|The linear regression assesses the relationship between baseline baseline steroid use and BMD change at 6 months (outcome).||59 patients were accrued to the study. The 27 patients with follow-up at 6 months are included in an analysis to assess the association between baseline steroid use and bone mass density at 6 months using linear regression.||||.2212
71020070|NCT00301873|141547011|SUPERIORITY_OR_OTHER||Slope|0.2357|STANDARD_ERROR_OF_MEAN|0.1091||0.0413||95.0||||this p-value is at test of whether the slope of the regression line is non-zero.|Regression, Linear|The linear regression assesses the relationship between anticonvulsant use and BMD change at 6 months (outcome).||59 patients were accrued to the study. The 27 patients with follow-up at 6 months are included in an analysis to assess the association between baseline anticonvulsant use and bone mass density at 6 months using linear regression||||.0413
71020071|NCT00301873|141547011|SUPERIORITY_OR_OTHER||Slope|-0.232|STANDARD_ERROR_OF_MEAN|0.1029||0.0418||95.0||||this p-value is at test of whether the slope of the regression line is non-zero.|Regression, Linear|The linear regression assesses the relationship between baseline steroid use and BMD change at 12 months (outcome).||59 patients were accrued to the study. The 19 patients with follow-up at 12 months are included in an analysis to assess the association between baseline steroid use and bone mass density at 12 months using linear regression||||.0418
71106171|NCT01576783|141718903|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.047||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.047
71106172|NCT01576783|141718904|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.2||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups. Model controlled for baseline scores.||||||0.20
71052667|NCT03056157|141609811|SUPERIORITY||Slope|-0.37||||0.04|TWO_SIDED|95.0|-0.72|-0.01|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Psychological Aggression scores, t(319) = -2.03, d = 0.23.||-0.01|-0.72|0.04
71052668|NCT03056157|141609811|SUPERIORITY||Slope|-0.83|||<|0.001|TWO_SIDED|95.0|-1.09|-0.58|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Psychological Aggression scores, t(116)= -6.40, d = 1.19.||-0.58|-1.09|<0.001
71052669|NCT03056157|141609811|SUPERIORITY||Slope|-0.47||||0.002|TWO_SIDED|95.0|-0.71|-0.22|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Psychological Aggression scores, t(116) = -3.78, d = 0.70.||-0.22|-0.71|0.002
71052670|NCT03056157|141609811|SUPERIORITY||Slope|-0.08||||0.58|TWO_SIDED|95.0|-0.37|0.21|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Psychological Aggression scores, t(319) = -0.56, d = 0.06.||0.21|-0.37|0.58
71052671|NCT03056157|141609811|SUPERIORITY||Slope|-0.1||||0.34|TWO_SIDED|95.0|-0.31|0.11|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Psychological Aggression scores, t(319) = -0.96, d = 0.11.||0.11|-0.31|0.34
71052672|NCT03056157|141609811|SUPERIORITY||Slope|-0.02||||0.85|TWO_SIDED|95.0|-0.22|0.18|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Psychological Aggression scores, t(319) = -0.19, d = 0.02.||0.18|-0.22|0.85
71052673|NCT03056157|141609812|SUPERIORITY|We log-transformed CTS2 scores because they were heavily positively skewed in conjunction with zero-inflation.|Slope|-0.23||||0.07|TWO_SIDED|95.0|-0.48|0.02|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Physical Assault scores, t(319)= -1.82, d = 0.20.||0.02|-0.48|0.07
71020072|NCT00301873|141547011|SUPERIORITY_OR_OTHER||Slope|0.2123|STANDARD_ERROR_OF_MEAN|0.1209||0.1026||95.0||||the p-value is a test of whether the slope ofl the regression line is non-zero.|Regression, Linear|The linear regression assesses the relationship between anticonvulsant use and BMD change at 12 months.||59 patients were accrued to the study. The 19 patients with follow-up at 12 months are included in an analysis to assess the association between baseline anti-convulsant use and bone mass density at 12 months using linear regression||||.1026
71020073|NCT01211613|141547017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|STANDARD_DEVIATION|14.0||0.009|TWO_SIDED|95.0||||The p value above relates to the comparison of differences in baseline/4-week Oswestry change scores between manual and mechanical manipulation methods (primary hypothesis). A priori threshold for statistical significance was set at p \< 0.05.|Regression, Linear|Linear regression model was adjusted for these covariates: baseline Oswestry score, age, and treatment expectancy.||||||0.009
71020074|NCT01211613|141547018|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||The p value above relates to the comparison of differences in baseline/4-week Numeric pain change scores between manual and mechanical manipulation methods (secondary hypothesis). A priori threshold for statistical significance was set at p \< 0.05.|Regression, Linear|Linear regression model was adjusted for these covariates: baseline Numeric pain score, age, and treatment expectancy.||||||0.002
71020075|NCT03853213|141547019|SUPERIORITY||Mean difference (in change score)|2.54||||0.698|TWO_SIDED|95.0|-11.62|16.71|||t-test, 2 sided|The p-value is adjusted using the Satterthwaite correction due to unequal variances between the two groups.|A higher value of the estimation parameter of mean difference in change score indicates a greater reduction in the measure for the intervention group relative to the attention control group.|||16.71|-11.62|0.698
71020076|NCT03853213|141547020|SUPERIORITY||Mean Difference (Final Values)|-3.88||||0.123|TWO_SIDED|95.0|-9.0|1.24|||t-test, 2 sided||A lower value of the estimation parameter of mean difference indicates lower extent of medication nonadherence for the intervention relative to the control group.|Note that the measure of extent of medication nonadherence used the older 5-item version of the scale rather than the newer 3-item version of the scale because the IRB modification to change the measure took effect after the majority of participants who provided data for Visit 2 had completed the measure.||1.24|-9.00|0.123
71020077|NCT03853213|141547021|SUPERIORITY||Mean difference (in change score)|66.29||||0.965|TWO_SIDED|95.0|-3081.7|3214.3|||t-test, 2 sided|||||3214.3|-3081.7|0.965
71052674|NCT03056157|141609812|SUPERIORITY||Slope|-0.13||||0.17|TWO_SIDED|95.0|-0.31|-0.05|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Physical Assault scores, t(116) = -1.39, d = 0.16.||-0.05|-0.31|0.17
71052675|NCT03056157|141609812|SUPERIORITY||Slope|0.1||||0.24|TWO_SIDED|95.0|-0.07|0.27|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Physical Assault scores, t(116) = 1.18, d = 0.13.||0.27|-0.07|0.24
71052676|NCT03056157|141609812|SUPERIORITY||Slope|0.11||||0.71|TWO_SIDED|95.0|-0.23|0.15|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Physical Assault scores, t(319) = -0.37, d = 0.04.||0.15|-0.23|0.71
71052677|NCT03056157|141609812|SUPERIORITY||Slope|-0.07||||0.32|TWO_SIDED|95.0|-0.21|0.07|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Physical Assault scores, t(319) = -1.00, d = 0.11.||0.07|-0.21|0.32
71052678|NCT03056157|141609812|SUPERIORITY||Slope|-0.04||||0.61|TWO_SIDED|95.0|-0.17|0.1|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Physical Assault scores, t(319) = -0.51, d = 0.06.||0.10|-0.17|0.61
71052679|NCT03056157|141609813|SUPERIORITY||Slope|-0.07||||0.74|TWO_SIDED|95.0|-0.5|0.36|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DSI-SS scores, t(318) = -0.33, d = 0.04||0.36|-0.50|0.74
71052680|NCT03056157|141609813|SUPERIORITY||Slope|-0.12||||0.44|TWO_SIDED|95.0|-0.43|0.19|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DSI-SS scores, t(114) = -0.77, d = 0.14.||0.19|-0.43|0.44
71052681|NCT03056157|141609813|SUPERIORITY||Slope|-0.06||||0.74|TWO_SIDED|95.0|-0.35|0.24|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DSI-SS scores, t(114) = -0.34, d = 0.06.||0.24|-0.35|0.74
71052682|NCT03056157|141609813|SUPERIORITY||Slope|-0.1||||0.57|TWO_SIDED|95.0|-0.45|0.25|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DSI-SS scores, t(114) = -0.57, d = 0.11.||0.25|-0.45|0.57
71052683|NCT03056157|141609813|SUPERIORITY||Slope|-0.03||||0.82|TWO_SIDED|95.0|-0.28|0.22|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DSI-SS scores, t(114) = -0.23, d = 0.04.||0.22|-0.28|0.82
70851294|NCT00669409|141190539|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-23.3|10.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.0|-23.3|
71052684|NCT03056157|141609813|SUPERIORITY||Slope|0.07||||0.57|TWO_SIDED|95.0|-0.17|0.31|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DSI-SS scores, t(114) = 0.58, d = 0.11.||0.31|-0.17|0.57
71052685|NCT03056157|141609814|SUPERIORITY||Slope|-1.1||||0.16|TWO_SIDED|95.0|-2.63|0.43|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for QDS scores, t(316) = -1.42, d = 0.16.||0.43|-2.63|0.16
70851295|NCT00669409|141190539|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.8|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-31.2|1.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.6|-31.2|
70851296|NCT00669409|141190539|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-28.2|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-50.0|-6.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-6.4|-50.0|
70932327|NCT02307682|141364357|OTHER||Difference in proportions|10.6|||||TWO_SIDED|95.0|5.0|16.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||16.2|5.0|
71052686|NCT03056157|141609814|SUPERIORITY||Slope|-0.76||||0.18|TWO_SIDED|95.0|-1.87|0.35|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for QDS scores, t(114)= -1.35, d = 0.25.||0.35|-1.87|0.18
71052687|NCT03056157|141609814|SUPERIORITY||Slope|0.34||||0.53|TWO_SIDED|95.0|-0.71|1.39|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for QDS scores, t(114) = 0.63, d = 0.12.||1.39|-0.71|0.53
71052688|NCT03056157|141609814|SUPERIORITY||Slope|-0.6||||0.37|TWO_SIDED|95.0|-1.93|0.73|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for QDS scores, t(316) = -0.89, d = 0.12.||0.73|-1.93|.37
71052689|NCT03056157|141609814|SUPERIORITY||Slope|-0.04||||0.94|TWO_SIDED|95.0|-1.0|0.92|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for QDS scores, t(114) = -0.08, d = 0.02.||0.92|-1.00|0.94
71052690|NCT03056157|141609814|SUPERIORITY||Slope|0.57||||0.23|TWO_SIDED|95.0|-0.35|1.48|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for QDS scores, t(114) = 1.21, d = 0.23.||1.48|-0.35|0.23
71052691|NCT03056157|141609815|SUPERIORITY||Slope|3.98||||0.01|TWO_SIDED|95.0|0.83|7.13|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(316) = 2.49, d = 0.28.||7.13|0.83|0.01
71052692|NCT03056157|141609815|SUPERIORITY||Slope|4.84|||<|0.001|TWO_SIDED|95.0|2.55|7.13|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(114) = 4.16, d = 0.78.||7.13|2.55|<0.001
71052693|NCT03056157|141609815|SUPERIORITY||Slope|0.85||||0.44|TWO_SIDED|95.0|-1.31|3.02|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(114) = 0.78, d = 0.15.||3.02|-1.31|0.44
71052694|NCT03056157|141609815|SUPERIORITY||Slope|0.21||||0.88|TWO_SIDED|95.0|-2.32|2.75|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(316) = 0.17, d = 0.02.||2.75|-2.32|0.88
71052695|NCT03056157|141609815|SUPERIORITY||Slope|0.55||||0.55|TWO_SIDED|95.0|-1.27|2.37|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(316) = 0.60, d = 0.07.||2.37|-1.27|0.55
71052696|NCT03056157|141609815|SUPERIORITY||Slope|0.38||||0.7|TWO_SIDED|95.0|-1.42|2.1|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(316) = 0.38, d = 0.04.||2.10|-1.42|0.70
71052697|NCT03056157|141609816|SUPERIORITY||Slope|-0.04||||0.8|TWO_SIDED|95.0|-0.32|0.25|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCBSC scores, t(318) = -0.25, d = 0.03.||0.25|-0.32|0.80
70851297|NCT00669409|141190540|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|7.3|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-9.4|24.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||24.0|-9.4|
71052698|NCT03056157|141609816|SUPERIORITY||Slope|0.04||||0.57|TWO_SIDED|95.0|-0.09|0.16|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCBSC scores, t(115) = 0.57, d = 0.11.||0.16|-0.09|0.57
71052699|NCT03056157|141609816|SUPERIORITY||Slope|-0.01||||0.82|TWO_SIDED|95.0|-0.14|0.11|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCBSC scores, t(115) = -0.23, d = 0.04.||0.11|-0.14|0.82
71052700|NCT03056157|141609816|SUPERIORITY||Slope|0.05||||0.57|TWO_SIDED|95.0|-0.13|0.23|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCBSC scores, t(320) = 0.57, d = 0.06.||0.23|-0.13|0.57
71052701|NCT03056157|141609817|SUPERIORITY||Slope|3.91||||0.002|TWO_SIDED|95.0|1.48|6.35|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for VLQ scores, t(408) = 3.16, d = 0.32.||6.35|1.48|0.002
71052702|NCT03056157|141609817|SUPERIORITY||Slope|4.16|||<|0.001|TWO_SIDED|95.0|2.41|5.92|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for VLQ scores, t(121) = 4.66, d = 0.85.||5.92|2.41|<0.001
71052703|NCT03056157|141609817|SUPERIORITY||Slope|0.25||||0.78|TWO_SIDED|95.0|-1.44|1.94|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for VLQ scores, t(121) = 0.63, d = 0.11.||1.94|-1.44|0.78
71052704|NCT03056157|141609817|SUPERIORITY||Slope|-0.05||||0.73|TWO_SIDED|95.0|-0.34|0.24|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for VLQ scores, t(408) = -0.34, d = 0.01.||0.24|-0.34|0.73
71052705|NCT03056157|141609817|SUPERIORITY||Slope|0.06||||0.58|TWO_SIDED|95.0|-0.15|0.27|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for VLQ scores, t(408) = 0.56, d = 0.06.||0.27|-0.15|0.58
71052706|NCT03056157|141609817|SUPERIORITY||Slope|0.11||||0.28|TWO_SIDED|95.0|-0.1|0.31|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for VLQ scores, t(408) = 1.07, d = 0.11.||0.31|-0.10|0.28
71052707|NCT00806286|141609818|SUPERIORITY||Mean Difference (Final Values)|-23.2|||<|0.0001|TWO_SIDED|||||Two-sided p-value is calculated by dividing the square of the treatment group difference on the log-log scale by the standard error of the difference and referring the result to the standard normal distribution.|Z-test||The estimated value represents the difference in treatments (%).|||||<0.0001
71052708|NCT00806286|141609818|SUPERIORITY||Cox Proportional Hazard|1.579||||0.0499|TWO_SIDED|95.0|1.0|2.5|||Regression, Cox|||||2.5|1.0|0.0499
71052709|NCT00806286|141609819|SUPERIORITY|Two-sided p-value is calculated by dividing the square of the treatment group difference on the log-log scale by the standard error of the difference and referring the result to the standard normal distribution.|Mean Difference (Final Values)|-25.5|||<|0.0001|TWO_SIDED||||||Z-test||The estimated value represents the difference in treatments (%).|||||<0.0001
71052710|NCT03469336|141609828|OTHER|Ratio|Mean Ratio (Test/Reference)|1.0109|STANDARD_ERROR_OF_MEAN|0.732||0.9883|TWO_SIDED|95.0|0.2364|4.3226|||Mixed Models Analysis|||The efficacy assessment of PF-06763809 was performed for the change from baseline in log of the psoriatic skin infiltrate thickness/EPB on Day 19 using a longitudinal analysis of covariance model, with treatment, visit, treatment by visit interaction as main effects and the log of the psoriatic skin infiltrate thickness/EPB at baseline as covariate.||4.3226|0.2364|0.9883
71052711|NCT03469336|141609828|OTHER|Ratio|Mean Ratio (Test/Reference)|0.9979|STANDARD_ERROR_OF_MEAN|0.732||0.9977|TWO_SIDED|95.0|0.2334|4.2671|||Mixed Models Analysis|||The efficacy assessment of PF-06763809 was performed for the change from baseline in log of the psoriatic skin infiltrate thickness/EPB on Day 19 using a longitudinal analysis of covariance model, with treatment, visit, treatment by visit interaction as main effects and the log of the psoriatic skin infiltrate thickness/EPB at baseline as covariate.||4.2671|0.2334|0.9977
71106173|NCT01576783|141718905|OTHER|Results are the comparison of proportion of those with a developmental condition between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).|Odds Ratio (OR)|1.63|||||TWO_SIDED|95.0|0.8|3.32||||||||3.32|0.80|
71106174|NCT01576783|141718906|OTHER|Results are the comparison of proportion of those with a behavioral condition between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).|Odds Ratio (OR)|4.5|||||TWO_SIDED|95.0|0.52|39.15||||||||39.15|0.52|
71106175|NCT02180828|141718942|NON_INFERIORITY_OR_EQUIVALENCE|Yes||||||0.925|||||||Chi-squared|||||||0.925
71052712|NCT03469336|141609828|OTHER|Ratio|Mean Ratio (Test/Reference)|1.1382|STANDARD_ERROR_OF_MEAN|0.732||0.86|TWO_SIDED|95.0|0.2662|4.867|||Mixed Models Analysis|||The efficacy assessment of PF-06763809 was performed for the change from baseline in log of the psoriatic skin infiltrate thickness/EPB on Day 19 using a longitudinal analysis of covariance model, with treatment, visit, treatment by visit interaction as main effects and the log of the psoriatic skin infiltrate thickness/EPB at baseline as covariate.||4.8670|0.2662|0.8600
71052713|NCT03469336|141609833|OTHER|Ratio|Mean Ratio (Test/Reference)|0.9979|STANDARD_ERROR_OF_MEAN|0.071||0.9763|TWO_SIDED|95.0|0.8588|1.1594|||Mixed Models Analysis|||To evaluate the AUC of psoriatic skin infiltrate thickness/EPB for PF-06763809 compared to vehicle.||1.1594|0.8588|0.9763
71020078|NCT03853213|141547022|SUPERIORITY||Mean difference (in change score)|-6.17||||0.29|TWO_SIDED|95.0|-18.15|5.81|||t-test, 2 sided||A higher value of the estimation parameter of mean difference in change score indicates a greater increase in context sensitivity for the intervention group relative to the attention control group.|||5.81|-18.15|0.290
71020079|NCT03853213|141547023|SUPERIORITY||Mean difference (in change score)|-5.07||||0.434|TWO_SIDED|95.0|-18.51|8.38|||t-test, 2 sided||A higher value of the estimation parameter of mean difference in change score indicates a greater increase in future time perspective for the intervention group relative to the attention control group.|||8.38|-18.51|0.434
71052714|NCT03469336|141609833|OTHER|Ratio|Mean Ratio (Test/Reference)|0.9664|STANDARD_ERROR_OF_MEAN|0.051||0.5081|TWO_SIDED|95.0|0.8686|1.0752|||Mixed Models Analysis|||To evaluate the AUC of psoriatic skin infiltrate thickness/EPB for PF-06763809 compared to vehicle.||1.0752|0.8686|0.5081
71052715|NCT03469336|141609833|OTHER|Ratio|Mean Ratio (Test/Reference)|1.1155|STANDARD_ERROR_OF_MEAN|0.044||0.0249|TWO_SIDED|95.0|1.0157|1.2252|||Mixed Models Analysis|||To evaluate the AUC of psoriatic skin infiltrate thickness/EPB for PF-06763809 compared to vehicle.||1.2252|1.0157|0.0249
71020080|NCT03853213|141547024|SUPERIORITY||Mean Difference (Final Values)|17.05||||0.293|TWO_SIDED|95.0|-19.07|53.17|||t-test, 2 sided||A higher value of the estimation parameter of mean difference indicates a lower extent of objectively measured medication adherence for the intervention relative to the control group.|||53.17|-19.07|0.293
71020081|NCT02239692|141547038|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is assessed by examining whether the upper limit of the 95% confidence interval is less than the specified non-inferiority margin of 1.5 points.|Adjusted estimated mean difference|-3.93|||<|0.0001|TWO_SIDED|95.0|-4.99|-2.87||p-value corresponds to a two-sided test of superiority.|ANCOVA|ANCOVA with treatment, country and time of colonoscopy (AM/PM) as factors.|Treatment difference in mean total Ottawa Scale score was calculated as PICOPREP tailored dosing schedule minus PICOPREP day-before dosing schedule.|Null hypothesis was no treatment difference between the two dosing schedules.||-2.87|-4.99|<0.0001
71020082|NCT02239692|141547039|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is assessed by examining whether the upper limit of the 95% confidence interval is less than the specified non-inferiority margin of 1.5 points.|Adjusted estimated mean difference|-4.38|||<|0.0001|TWO_SIDED|95.0|-5.34|-3.41||p-value corresponds to a two-sided test of superiority.|ANCOVA|ANCOVA with treatment, country and time of colonoscopy (AM/PM) as factors.|Treatment difference in mean total Ottawa Scale score was calculated as PICOPREP tailored dosing schedule minus PICOPREP day-before dosing schedule.|Null hypothesis was no treatment difference between the two dosing schedules.||-3.41|-5.34|<0.0001
71020083|NCT02239692|141547040|SUPERIORITY_OR_OTHER||Adjusted estimated odds ratio|9.18|||<|0.0001|TWO_SIDED|95.0|4.36|19.32||p-value corresponds to a two-sided test of superiority.|Regression, Logistic|Logistic regression with the failure/success status as dependent variable, and treatment, country and timing of colonoscopy as factors.|The estimated odds ratio compares the odds of being a responder in the PICOPREP tailored dosing schedule vs. the PICOPREP day-before dosing schedule.|Null hypothesis was no treatment difference between the two dosing schedules.||19.32|4.36|<0.0001
71052716|NCT03469336|141609834|OTHER|Ratio|Mean Ratio (Test/Reference)|0.7946|STANDARD_ERROR_OF_MEAN|0.732||0.754|TWO_SIDED|95.0|0.1858|3.3977|||Mixed Models Analysis|||The effect of PF-06763809 compared to calcipotriene/calcipotriol solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.||3.3977|0.1858|0.7540
71106176|NCT02180828|141718943|NON_INFERIORITY_OR_EQUIVALENCE|Yes||||||0.298|||||||Chi-squared|||||||0.298
71106177|NCT02180828|141718944|NON_INFERIORITY_OR_EQUIVALENCE|90% power and a two-sided alpha level of 0.05||||||0.147|||||||Chi-squared|||||||0.147
71106178|NCT02180828|141718945|NON_INFERIORITY_OR_EQUIVALENCE|Yes||||||0.147|||||||Chi-squared|||||||0.147
71052717|NCT03469336|141609834|OTHER|Ratio|Mean Ratio (Test/Reference)|0.7844|STANDARD_ERROR_OF_MEAN|0.732||0.7407|TWO_SIDED|95.0|0.1834|3.354|||Mixed Models Analysis|||The effect of PF-06763809 compared to calcipotriene/calcipotriol solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.||3.3540|0.1834|0.7407
71052718|NCT03469336|141609834|OTHER|Ratio|Mean Ratio (Test/Reference)|0.8946|STANDARD_ERROR_OF_MEAN|0.732||0.8793|TWO_SIDED|95.0|0.2092|3.8256|||Mixed Models Analysis|||The effect of PF-06763809 compared to calcipotriene/calcipotriol solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.||3.8256|0.2092|0.8793
71052719|NCT03469336|141609835|OTHER|Ratio|Mean Ratio (Test/Reference)|1.081321|STANDARD_ERROR_OF_MEAN|0.732|<|0.0001|TWO_SIDED|95.0|0.25287|4.623941|||Mixed Models Analysis|||The effect of PF-06763809 compared to betamethasone solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.||4.623941|0.25287|<0.0001
71106179|NCT02180828|141718946|SUPERIORITY_OR_OTHER|||||||0.01|||||||Chi-squared|||||||0.010
71106180|NCT02180828|141718947|SUPERIORITY_OR_OTHER|||||||0.002|||||||Chi-squared|||||||0.002
71106181|NCT02180828|141718948|SUPERIORITY_OR_OTHER|||||||0.658|||||||Chi-squared|||||||0.658
71106182|NCT02180828|141718949|SUPERIORITY_OR_OTHER|||||||0.123|||||||Chi-squared|||||||0.123
71106183|NCT02180828|141718950|SUPERIORITY_OR_OTHER|||||||0.274|||||||Chi-squared|||||||0.274
71106184|NCT01276704|141718951|SUPERIORITY|||||||0.72||||||a priori threshold for statistical significance: \< 0.05|Wilcoxon (Mann-Whitney)|||83% power to detect an absolute 2.5% reduction in Ki-67 for the treatment group compared with no reduction in the control group.||||0.72
71106185|NCT01276704|141718952|SUPERIORITY|||||||0.018||||||No adjustment for multiple comparisons. Standard threshold of P\<0.05|Wilcoxon (Mann-Whitney)|||||||0.018
71106186|NCT01276704|141718953|SUPERIORITY|||||||0.036||||||No adjustment for multiple comparisons. Standard threshold of P \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.036
71106187|NCT03801525|141718959|SUPERIORITY||Hazard Ratio (HR)|0.778||||0.696|TWO_SIDED|95.0|0.219|2.755|||Log Rank|||||2.755|0.219|0.6960
71020084|NCT02437890|141547064|SUPERIORITY||||||=|0.526||||||Threshold for statistical significance: p = 0.05|Multiple Contrast Test|||"A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.~Model tested: linear model"||||= 0.526
71020085|NCT02437890|141547064|SUPERIORITY||||||=|0.504||||||Threshold for statistical significance: p = 0.05|Multiple Contrast Test|||"A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.~Model tested: Emax model"||||= 0.504
71020086|NCT02437890|141547064|SUPERIORITY||||||=|0.548||||||Threshold for statistical significance: p = 0.05|Multiple Contrast Test|||"A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.~Model tested: logistic model"||||= 0.548
71020087|NCT02437890|141547064|SUPERIORITY||||||=|0.985||||||Threshold for statistical significance: p = 0.05|Multiple Contrast Test|||"A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.~Model tested: 1st Beta model"||||= 0.985
71020088|NCT02437890|141547064|SUPERIORITY||||||=|0.524||||||Threshold for statistical significance: p = 0.05|Multiple Contrast Test|||"A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.~Model tested: 2nd Beta model"||||= 0.524
71020089|NCT02625207|141547135|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|116.73||||0.1318|TWO_SIDED|90.0|98.55|138.26|||Mixed Models Analysis|||||138.26|98.55|0.1318
71020090|NCT02625207|141547135|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|85.85||||0.1369|TWO_SIDED|90.0|72.48|101.68|||Mixed Models Analysis|||||101.68|72.48|0.1369
71020091|NCT02625207|141547135|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|63.38|||<|0.0001|TWO_SIDED|90.0|53.51|75.07|||Mixed Models Analysis|||||75.07|53.51|< 0.0001
71020092|NCT02625207|141547135|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|73.83||||0.0036|TWO_SIDED|90.0|62.57|87.13|||Mixed Models Analysis|||||87.13|62.57|0.0036
71052720|NCT03469336|141609835|OTHER|Ratio|Mean Ratio (Test/Reference)|1.067453|STANDARD_ERROR_OF_MEAN|0.732|<|0.0001|TWO_SIDED|95.0|0.249631|4.564555|||Mixed Models Analysis|||The effect of PF-06763809 compared to betamethasone solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.||4.564555|0.249631|<0.0001
71052721|NCT03469336|141609835|OTHER|Ratio|Mean Ratio (Test/Reference)|1.217483|STANDARD_ERROR_OF_MEAN|0.732|<|0.0001|TWO_SIDED|95.0|0.284708|5.206258|||Mixed Models Analysis|||The effect of PF-06763809 compared to betamethasone solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.||5.206258|0.284708|<0.0001
71020093|NCT02625207|141547135|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean ratio|73.99||||0.0038|TWO_SIDED|90.0|62.7|87.31|||Mixed Models Analysis|||||87.31|62.70|0.0038
71020094|NCT02625207|141547136|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|82.59||||0.0531|TWO_SIDED|90.0|70.33|96.98|||Mixed Models Analysis|||||96.98|70.33|0.0531
71020095|NCT02625207|141547137|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|137.07||||0.0106|TWO_SIDED|90.0|112.4|167.15|||Mixed Models Analysis|||Statistical analysis of PF -6857639 was estimated and reported.||167.15|112.40|0.0106
71020096|NCT02625207|141547137|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|164.06||||0.0001|TWO_SIDED|90.0|134.54|200.06|||Mixed Models Analysis|||Statistical analysis of PF -6857639 was estimated and reported.||200.06|134.54|0.0001
71020097|NCT02625207|141547137|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|198.49|||<|0.0001|TWO_SIDED|90.0|162.77|242.05|||Mixed Models Analysis|||Statistical analysis of PF -6857639 was estimated and reported.||242.05|162.77|< 0.0001
71020098|NCT02625207|141547137|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|120.99||||0.1061|TWO_SIDED|90.0|99.65|146.9|||Mixed Models Analysis|||Statistical analysis of PF -6857639 was estimated and reported.||146.90|99.65|0.1061
71020099|NCT02625207|141547137|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|272.07|||<|0.0001|TWO_SIDED|90.0|224.08|330.33|||Mixed Models Analysis|||Statistical analysis of PF -6857639 was estimated and reported.||330.33|224.08|<0.0001
71020100|NCT02625207|141547137|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|110.22||||0.3081|TWO_SIDED|90.0|94.05|129.18|||Mixed Models Analysis|||Statistical analysis of PF -6857640 was estimated and reported.||129.18|94.05|0.3081
71020101|NCT02625207|141547137|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|101.71||||0.8583|TWO_SIDED|90.0|86.79|119.2|||Mixed Models Analysis|||Statistical analysis of PF -6857640 was estimated and reported.||119.20|86.79|0.8583
71020102|NCT02625207|141547137|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|108.52||||0.3913|TWO_SIDED|90.0|92.6|127.17|||Mixed Models Analysis|||Statistical analysis of PF -6857640 was estimated and reported.||127.17|92.60|0.3913
71020103|NCT02625207|141547137|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|106.69||||0.4866|TWO_SIDED|90.0|91.36|124.6|||Mixed Models Analysis|||Statistical analysis of PF -6857640 was estimated and reported.||124.60|91.36|0.4866
71052722|NCT00289536|141609937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1662|||||||ANOVA|Repeated measures ANOVA with dose as fixed effect||Null Hypothesis: The mean log initial recovery will be the same in each dose group.||||0.1662
71106188|NCT03801525|141718966|SUPERIORITY||Hazard Ratio (HR)|0.201||||0.1038|TWO_SIDED|95.0|0.023|1.721|||Log Rank|||||1.721|0.023|0.1038
71106189|NCT01440764|141719111|SUPERIORITY|||||||0.99||||||a priori threshold for significance was 0.05. Not corrected for multiple comparisons. This p-value describes the a priori analysis of comparing the furosemide test result to the saline test result.|t-test, 2 sided|||||||0.99
71106190|NCT01440764|141719111|SUPERIORITY|||||||0.32||||||a priori threshold for significance was 0.05. Not corrected for multiple comparisons. Thes p-value describes the a priori analysis of comparing the response to furosemide to the mean response to saline.|t-test, 2 sided|||||||0.32
71106191|NCT01440764|141719113|SUPERIORITY|||||||0.0006||||||a priori threshold for statistical significance was 0.05. Not adjusted for multiple comparisons.|t-test, 2 sided|||||||.0006
71106192|NCT01440764|141719113|SUPERIORITY||||||=|1e-05||||||a priori threshold for statistical significance was 0.05. Not adjusted for multiple comparisons.|t-test, 2 sided|||||||=.00001
71106193|NCT01440764|141719113|SUPERIORITY|||||||2e-07||||||a priori threshold for significance was 0.05. Not adjusted for multiple comparisons.|t-test, 2 sided|||||||.0000002
71106194|NCT00320606|141719114|OTHER||95% confidence interval using an exact b|0.6|||||TWO_SIDED|95.0|0.4|0.8|||||Proportion Success|The proportion of participants in whom immunosuppression withdrawal was attempted who are successfully withdrawn from immunosuppression are descriptively summarized with 95% confidence intervals using an exact binomial method||0.8|0.4|
71020104|NCT02625207|141547137|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|119.61||||0.059|TWO_SIDED|90.0|102.42|139.69|||Mixed Models Analysis|||Statistical analysis of PF -6857640 was estimated and reported.||139.69|102.42|0.0590
71020105|NCT02625207|141547137|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|99.7||||0.9816|TWO_SIDED|90.0|80.47|123.53|||Mixed Models Analysis|||Statistical analysis of PF -06927572 was estimated and reported.||123.53|80.47|0.9816
71020106|NCT02625207|141547137|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|105.12||||0.6974|TWO_SIDED|90.0|84.84|130.24|||Mixed Models Analysis|||Statistical analysis of PF -06927572 was estimated and reported.||130.24|84.84|0.6974
71020107|NCT02625207|141547137|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|101.03||||0.9363|TWO_SIDED|90.0|81.54|125.18|||Mixed Models Analysis|||Statistical analysis of PF -06927572 was estimated and reported.||125.18|81.54|0.9363
71020108|NCT02625207|141547137|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|96.11||||0.752|TWO_SIDED|90.0|77.94|118.52|||Mixed Models Analysis|||Statistical analysis of PF -06927572 was estimated and reported.||118.52|77.94|0.7520
71020109|NCT02625207|141547137|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|100.73||||0.9536|TWO_SIDED|90.0|81.69|124.22|||Mixed Models Analysis|||Statistical analysis of PF -06927572 was estimated and reported.||124.22|81.69|0.9536
71020110|NCT02625207|141547137|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|97.6||||0.8241|TWO_SIDED|90.0|81.28|117.18|||Mixed Models Analysis|||Statistical analysis of PF -06927573 was estimated and reported.||117.18|81.28|0.8241
71106195|NCT00320606|141719115|OTHER||Binomial Proportion|0.0|||||TWO_SIDED|95.0|0.0|0.1684|||||95% Confidence Interval Exact Binomial|The proportion of participants in whom immunosuppression (IS) withdrawal was attempted who are successfully withdrawn from immunosuppression and experience death or graft loss are descriptively summarized with 95% confidence intervals using an exact binomial method.||0.1684|0.0|
71106196|NCT02621892|141719257|SUPERIORITY||Risk Difference (RD)|8.31|||<|0.02|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.02
71106197|NCT02621892|141719259|SUPERIORITY||Risk Difference (RD)|10.86|||<|0.008|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.008
71020111|NCT02625207|141547137|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|118.5||||0.1261|TWO_SIDED|90.0|98.69|142.28|||Mixed Models Analysis|||Statistical analysis of PF -06927573 was estimated and reported.||142.28|98.69|0.1261
71020112|NCT02625207|141547137|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|99.6||||0.9708|TWO_SIDED|90.0|82.95|119.59|||Mixed Models Analysis|||Statistical analysis of PF -06927573 was estimated and reported.||119.59|82.95|0.9708
71020113|NCT02625207|141547137|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|84.05||||0.1099|TWO_SIDED|90.0|70.29|100.52|||Mixed Models Analysis|||Statistical analysis of PF -06927573 was estimated and reported.||100.52|70.29|0.1099
71052723|NCT00289536|141609938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0965||||||No adjustments were made for multiple comparisons.|ANOVA|Repeated measures ANOVA with dose as fixed effect||Null Hypothesis: The mean log AUC/dose will be the same in each dose group.||||0.0965
71052724|NCT00289536|141609939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5057|||||||ANOVA|Repeated measures ANOVA with dose as fixed effect||Null Hypothesis: The mean terminal half-life will be the same in each dose group.||||0.5057
71052725|NCT00289536|141609947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7048||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: Relationship of initial recovery to pre-infusion level of VWF:Rco with dose groups combined.||||0.7048
71052726|NCT00289536|141609947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0322||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: relationship of AUC/Dose to pre-infusion level of VWF:Rco with dose groups combined.||||.0322
71106198|NCT02621892|141719260|SUPERIORITY||Risk Difference (RD)|10.34|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71106199|NCT02621892|141719261|SUPERIORITY||Risk Difference (RD)|11.92|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71106200|NCT02621892|141719262|SUPERIORITY||Risk Difference (RD)|10.9|||<|0.003|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.003
71020114|NCT02625207|141547137|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|97.21||||0.7913|TWO_SIDED|90.0|81.29|116.25|||Mixed Models Analysis|||Statistical analysis of PF -06927573 was estimated and reported.||116.25|81.29|0.7913
71020115|NCT02625207|141547138|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|116.65||||0.1338|TWO_SIDED|90.0|98.47|138.18|||Mixed Models Analysis|||||138.18|98.47|0.1338
71020116|NCT02625207|141547138|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|85.84||||0.137|TWO_SIDED|90.0|72.46|101.68|||Mixed Models Analysis|||||101.68|72.46|0.1370
71052727|NCT00289536|141609947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: relationship of terminal half-life to pre-infusion level of VWF:Rco with dose groups combined.||||0.0056
71052728|NCT00289536|141609948|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3696||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: relationship of initial recovery to pre-infusion level of VWF:Ag with dose groups combined.||||0.3696
71106201|NCT03781479|141719263|OTHER||Mean Difference (Net)|0.792||||0.0083|TWO_SIDED|95.0|0.22|1.37|||Mixed Models Analysis||Results show the LSMeans for the estimated difference between treatments along with a 95% confidence interval for this difference.|A mixed effects liner model was fit with the HFMSE change from baseline (CFB) scores at Day 28 as a response and treatment, sequence, and treatment by sequence as fixed effect terms and patient as a random effect.||1.37|0.22|0.0083
71106202|NCT02921256|141719264|SUPERIORITY|||||||0.69|||||||Regression, Linear|||||||0.69
71052729|NCT00289536|141609948|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: relationship of AUC/Dose to pre-infusion level of VWF:Ag with dose groups combined.||||0.0001
71020117|NCT02625207|141547138|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|63.34|||<|0.0001|TWO_SIDED|90.0|53.47|75.04|||Mixed Models Analysis|||||75.04|53.47|< 0.0001
71052730|NCT00289536|141609948|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: relationship of terminal half-life to pre-infusion level of VWF:Ag with dose groups combined.||||<0.0001
71052731|NCT00265395|141609986|SUPERIORITY_OR_OTHER||SVR Rate Difference|-4.9||||0.6445||95.0|-20.4|10.6|||Asymptotic Z-test|||||10.6|-20.4|0.6445
71052732|NCT00271154|141609987|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||Null hypothesis: mean 12-month change in LVESVi in group 1 = mean 12-month change in LVESVi in group 2.||||<0.0001
71052733|NCT00271154|141609988|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Chi-squared|||Null hypothesis: Percentage worsened in CRT OFF group = Percentage worsened in CRT ON group||||0.10
71052734|NCT03055650|141610011|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.05.||Change from Baseline in Meibomian Gland Secretion Total Score at Week 1||||<0.0001
71052735|NCT03055650|141610011|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.05.||Change from Baseline in Meibomian Gland Secretion Total Score at Month 1||||<0.0001
71052736|NCT03055650|141610012|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.05.||Change From Baseline in Tear Break-Up Time (TBUT) at Week 1||||<0.0001
71052737|NCT03055650|141610012|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.05.||Change From Baseline in Tear Break-Up Time (TBUT) at Month 1||||<0.0001
71020118|NCT02625207|141547138|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean ratio|73.79||||0.0036|TWO_SIDED|90.0|62.53|87.09|||Mixed Models Analysis|||||87.09|62.53|0.0036
71020119|NCT02625207|141547138|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|73.89||||0.0037|TWO_SIDED|90.0|62.61|87.2|||Mixed Models Analysis|||||87.20|62.61|0.0037
71020120|NCT02625207|141547139|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|82.42||||0.0507|TWO_SIDED|90.0|70.2|96.77|||Mixed Models Analysis|||||96.77|70.20|0.0507
71020121|NCT02625207|141547140|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|118.19||||0.1997|TWO_SIDED|90.0|95.26|146.63|||Mixed Models Analysis|||||146.63|95.26|0.1997
71020122|NCT02625207|141547140|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|87.28||||0.2947|TWO_SIDED|90.0|70.34|108.28|||Mixed Models Analysis|||||108.28|70.34|0.2947
71020123|NCT02625207|141547140|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|61.23||||0.0004|TWO_SIDED|90.0|49.35|75.97|||Mixed Models Analysis|||||75.97|49.35|0.0004
71020124|NCT02625207|141547140|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|70.16||||0.0071|TWO_SIDED|90.0|56.81|86.63|||Mixed Models Analysis|||||86.63|56.81|0.0071
71020125|NCT02625207|141547140|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|72.37||||0.0135|TWO_SIDED|90.0|58.6|89.36|||Mixed Models Analysis|||||89.36|58.60|0.0135
71020126|NCT02625207|141547141|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|68.32||||0.0505|TWO_SIDED|90.0|49.81|93.71|||Mixed Models Analysis|||||93.71|49.81|0.0505
71020127|NCT02625207|141547142|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|94.83||||0.6761|TWO_SIDED|90.0|76.7|117.24|||Mixed Models Analysis|||||117.24|76.70|0.6761
71020128|NCT02625207|141547142|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|105.43||||0.6771||90.0|85.28|130.35|||Mixed Models Analysis|||||130.35|85.28|0.6771
71020129|NCT02625207|141547142|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|75.74||||0.0331|TWO_SIDED|90.0|61.26|93.64|||Mixed Models Analysis|||||93.64|61.26|0.0331
71020130|NCT02625207|141547142|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|71.84||||0.0104|TWO_SIDED|90.0|58.38|88.4|||Mixed Models Analysis|||||88.40|58.38|0.0104
71020131|NCT02625207|141547142|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|71.82||||0.0104|TWO_SIDED|90.0|58.37|88.39|||Mixed Models Analysis|||||88.39|58.37|0.0104
71020132|NCT02625207|141547143|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|99.62||||0.9713|TWO_SIDED|90.0|83.07|119.45|||Mixed Models Analysis|||||119.45|83.07|0.9713
71020133|NCT01160198|141547170|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Paired t-test|||Baseline Hb vs. Hb at Week 8 for Ferrous bisglycinate chelate 60 mg 1 once-daily||||<0.0001
71020134|NCT01160198|141547170|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Paired t-test|||Baseline Hb vs. Hb at Week 8 for Ferrous bisglycinate chelate 60 mg 1 twice-daily||||<0.0001
71020135|NCT01160198|141547172|SUPERIORITY_OR_OTHER|||||||0.788|||||||Chi-squared|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous bisglycinate chelate 60 mg 1 twice-daily||||0.788
71020136|NCT01160198|141547172|SUPERIORITY_OR_OTHER|||||||0.911|||||||Chi-squared|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous ascorbate 100mg 1 once-daily||||0.911
71020137|NCT01160198|141547172|SUPERIORITY_OR_OTHER|||||||0.7|||||||Chi-squared|||Ferrous bisglycinate chelate 60 mg 1 twice-daily vs. Ferrous ascorbate 100mg 1 once-daily||||0.700
71020138|NCT01160198|141547173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-0.29|0.17|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous bisglycinate chelate 60 mg 1 twice-daily at Week 2||0.17|-0.29|1
71020139|NCT01160198|141547173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||1||95.0|-0.57|0.31|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous bisglycinate chelate 60 mg 1 twice-daily at Week 4||0.31|-0.57|1
71020140|NCT01160198|141547173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-0.75|0.46|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous bisglycinate chelate 60 mg 1 twice-daily at Week 6||0.46|-0.75|1
70932328|NCT02307682|141364357|OTHER||Difference in proportions|10.0|||||TWO_SIDED|95.0|4.7|15.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||15.4|4.7|
70932329|NCT02307682|141364357|OTHER||Difference in proportions|-4.0|||||TWO_SIDED|95.0|-9.8|1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||1.7|-9.8|
70932330|NCT02307682|141364357|OTHER||Difference in proportions|-9.0|||||TWO_SIDED|95.0|-14.9|-3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-3.0|-14.9|
70932331|NCT02307682|141364357|OTHER||Difference in proportions|2.9|||||TWO_SIDED|95.0|-2.1|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||8.4|-2.1|
70932332|NCT02307682|141364357|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-6.3|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||5.1|-6.3|
71106203|NCT02921256|141719264|SUPERIORITY|||||||0.26|||||||Regression, Linear|||||||0.26
71106204|NCT04211363|141719290|SUPERIORITY||Odds Ratio (OR)|20.69|||<|0.0001|TWO_SIDED|95.0|7.58|56.48|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data..|IGA Success Odds Ratio||56.48|7.58|<0.0001
70932333|NCT02307682|141364357|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-5.8|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||6.1|-5.8|
70932334|NCT02307682|141364357|OTHER||Difference in proportions|-2.5|||||TWO_SIDED|95.0|-8.4|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||3.5|-8.4|
70932335|NCT02307682|141364357|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-6.4|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||4.4|-6.4|
70932336|NCT02307682|141364357|OTHER||Difference in proportions|-2.3|||||TWO_SIDED|95.0|-7.8|3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||3.0|-7.8|
71020141|NCT01160198|141547173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||1|TWO_SIDED|95.0|-1.05|0.53|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous bisglycinate chelate 60 mg 1 twice-daily at Week 8||0.53|-1.05|1
71020142|NCT01160198|141547173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.49|TWO_SIDED|95.0|-0.35|0.09|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous ascorbate 100mg 1 once-daily at Week 2||0.09|-0.35|0.490
71020143|NCT01160198|141547173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||1|TWO_SIDED|95.0|-0.58|0.29|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 4||0.29|-0.58|1
71052738|NCT03055650|141610013|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.025.||Change From Baseline in Standard Patient Evaluation of Eye Dryness (SPEED) Total Score at Week 1||||<0.0001
71052739|NCT03055650|141610013|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.025.||Change From Baseline in Standard Patient Evaluation of Eye Dryness (SPEED) Total Score at Month 1||||<0.0001
71052740|NCT03055650|141610014|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.025.||||||<0.0001
71020144|NCT01160198|141547173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-0.68|0.51|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 6||0.51|-0.68|1
71020145|NCT01160198|141547173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-0.84|0.72|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 8||0.72|-0.84|1
71077908|NCT02913105|141664398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.7261|TWO_SIDED|90.0|0.89|1.19|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 84||1.19|0.89|0.7261
71106205|NCT04211363|141719291|SUPERIORITY||Hazard Ratio (HR)|3.867|||<|0.0001|TWO_SIDED|95.0|2.795|5.351|||Log Rank|Unstratified log-rank test|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization.|Time to PASI-50||5.351|2.795|<0.0001
71106206|NCT04211363|141719292|SUPERIORITY||Odds Ratio (OR)|12.0|||<|0.0001|TWO_SIDED|95.0|5.15|27.93|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|PASI-75 at Week 8 Odds Ratio||27.93|5.15|<0.0001
70932337|NCT02307682|141364357|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-9.6|1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||1.7|-9.6|
70932338|NCT02307682|141364357|OTHER||Difference in proportions|-4.6|||||TWO_SIDED|95.0|-10.2|1.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||1.9|-10.2|
71106207|NCT04211363|141719293|SUPERIORITY||Odds Ratio (OR)|17.9|||<|0.0001|TWO_SIDED|95.0|4.38|73.09|||Cochran-Mantel-Haenszel|Stratified by study site, baseline IGA score, and baseline intertriginous involvement with multiple imputation of missing data.|Cochran-Mantel-Haenszel stratified by study site, baseline IGA score, and baseline intertriginous involvement with multiple imputation of missing data.|PASI-90 at Week 8 Odds Ratio||73.09|4.38|<0.0001
71106208|NCT04211363|141719294|SUPERIORITY||Odds Ratio (OR)|17.94|||<|0.0001|TWO_SIDED|95.0|2.33|138.2|||Cochran-Mantel-Haenszel|Stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|I-IGA Success at Week 8 Odds Ratio||138.20|2.33|<0.0001
71106209|NCT04211363|141719295|SUPERIORITY||Odds Ratio (OR)|29.36||||0.003|TWO_SIDED|95.0|2.99|288.36|||Cochran-Mantel-Haenszel|Stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|I-IGA Clear at Week 8 Odds Ratio||288.36|2.99|0.003
70932339|NCT02307682|141364357|OTHER||Difference in proportions|4.6|||||TWO_SIDED|95.0|-1.0|9.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||9.9|-1.0|
71020146|NCT01160198|141547173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-0.29|0.15|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 twice-daily vs. Ferrous ascorbate 100mg 1 once-daily at Week 2||0.15|-0.29|1
71020147|NCT01160198|141547173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-0.45|0.42|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 twice-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 4||0.42|-0.45|1
71020148|NCT01160198|141547173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||1|TWO_SIDED|95.0|-0.53|0.65|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 twice-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 6||0.65|-0.53|1
71020149|NCT01160198|141547173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||1|TWO_SIDED|95.0|-0.58|0.98|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 twice-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 8||0.98|-0.58|1
71020150|NCT03555890|141547199|EQUIVALENCE|If the 90 percent (%) confidence interval of the geometric mean ratio (Levocetirizine ODT/ Levocetirizine IRT) was within the acceptable range of 0.80 to 1.25 then Levocetirizine ODT was to be considered bioequivalent to the Levocetirizine IRT.|Ratio of geometric mean|0.975|||||TWO_SIDED|90.0|0.948|1.003||||||||1.003|0.948|
71020151|NCT03555890|141547200|EQUIVALENCE|If the 90 percent (%) confidence interval of the geometric mean ratio (Levocetirizine ODT/ Levocetirizine IRT) was within the acceptable range of 0.80 to 1.25 then Levocetirizine ODT was to be considered bioequivalent to the Levocetirizine IRT.|Ratio of geometric mean|0.978|||||TWO_SIDED|90.0|0.958|0.998||||||||0.998|0.958|
71020152|NCT03555890|141547201|EQUIVALENCE|If the 90 percent (%) confidence interval of the geometric mean ratio (Levocetirizine ODT/ Levocetirizine IRT) was within the acceptable range of 0.80 to 1.25 then Levocetirizine ODT was to be considered bioequivalent to the Levocetirizine IRT.|Ratio of geometric mean|0.934|||||TWO_SIDED|90.0|0.875|0.998||||||||0.998|0.875|
71020153|NCT03555890|141547202|EQUIVALENCE|If the 90 percent (%) confidence interval of the geometric mean ratio (Levocetirizine ODT/ Levocetirizine IRT) was within the acceptable range of 0.80 to 1.25 then Levocetirizine ODT was to be considered bioequivalent to the Levocetirizine IRT.|Ratio of geometric mean|0.857|||||TWO_SIDED|90.0|0.815|0.902||||||||0.902|0.815|
71020154|NCT01818414|141547263|SUPERIORITY_OR_OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
71020155|NCT01818414|141547264|SUPERIORITY_OR_OTHER|||||||0.052|||||||t-test, 2 sided|||||||0.052
71020156|NCT00450177|141547279|OTHER|||||||0.03|||||||Chi-squared|||||||0.03
71020157|NCT02613416|141547285|OTHER|||||||0.026||||||The p value was calculated.|Blyth-Still Casella Confidence Interval|||The primary hypothesis for this early phase study was that at least 30% of women would experience a \>5% relative decrease in their breast density after 6 months of treatment with denosumab 120 mg subcutaneous dose once a month.||||0.026
71020158|NCT00763269|141547287|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71020159|NCT00763269|141547288|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71020160|NCT00763269|141547289|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71020161|NCT00763269|141547290|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71020162|NCT01398982|141547291|NON_INFERIORITY_OR_EQUIVALENCE|Based on our published prospective, nonrandomized study using TAP block in abdominally-based autologous tissue breast reconstruction, 40 patients per group would achieve 85% power to detect a 65% reduction in mean total opioid consumption between the control and study groups (significance level alpha = 0.05; using a two-sided Wilcoxon rank-sum test).||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.02
71052741|NCT04135196|141610044|OTHER|||||||0.119|||||||Regression, Linear|||"The power analysis for the overall study was based on 12-month change in UD iBMC. The power calculation, based on pilot data, determined that 20 participants per group would have 80% power to detect a 1.0±1.1% change.~The null hypothesis was that change in UD iBMC was not proportional to strain magnitude. Raw change in iBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group."|"Overall model fit: R\^2=0.101, F=2.244, df1=2, df2=40, p=0.119~Contrast between the low strain magnitude group and the control group: B=0.015, Std. Error of estimate of B=0.007, Beta=0.374, t=2.114, p=0.041, 95% CI of B: \[0.001, 0.030\]~Contrast between the high strain magnitude group and the control group: B=0.009, Std. Error of estimate of B=0.007, Beta=0.221, t=1.247, p=0.220, 95% CI of B: \[-0.005, 0.022\]"|||0.119
71052742|NCT04135196|141610044|OTHER||||||<|0.01|||||||Regression, Linear|||The null hypothesis was that change in UD iBMC was not proportional to strain rate. Raw change in iBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.438, F=12.836, df1=2, df2=33, p=\<0.001~Contrast between the low strain rate group and the control group: B=0.036, Std. Error of estimate of B=0.009, Beta=0.599, t=4.050, p=\<0.001, 95% CI of B: \[0.018, 0.055\]~Contrast between the high strain rate group and the control group: B=0.041, Std. Error of estimate of B=0.009, Beta=0.678, t=4.589, p=\<0.001, 95% CI of B: \[0.023, 0.060\]"|||<0.01
71052743|NCT04135196|141610045|OTHER|||||||0.809|||||||Regression, Linear|||The null hypothesis was that change in UD cBMC was not proportional to strain magnitude. Raw change in cBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.011, F=0.213, df1=2, df2=40, p=0.809~Contrast between the low strain magnitude group and the control group: B=0.001, Std. Error of estimate of B=0.006, Beta=0.039, t=0.209, p=0.836, 95% CI of B: \[-0.012, 0.014\]~Contrast between the high strain magnitude group and the control group: B=-0.002, Std. Error of estimate of B=0.006, Beta=-0.077, t=-0.412, p=0.682, 95% CI of B: \[-0.015, 0.010\]"|||0.809
71052744|NCT04135196|141610045|OTHER|||||||0.155|||||||Regression, Linear|||The null hypothesis was that change in UD cBMC was not proportional to strain rate. Raw change in cBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.107, F=1.971, df1=2, df2=33, p=0.155~Contrast between the low strain rate group and the control group: B=0.012, Std. Error of estimate of B=0.008, Beta=0.284, t=1.526, p=0.137, 95% CI of B: \[-0.004, 0.027\]~Contrast between the high strain rate group and the control group: B=0.014, Std. Error of estimate of B=0.008, Beta=0.342, t=1.837, p=0.075, 95% CI of B: \[-0.002, 0.030\]"|||0.155
71052745|NCT04135196|141610046|OTHER|||||||0.991|||||||Regression, Linear|||The null hypothesis was that change in UD ecBMC was not proportional to strain magnitude. Raw change in ecBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=\<0.001, F=0.009, df1=2, df2=40, p=0.991~Contrast between the low strain magnitude group and the control group: B=0.001, Std. Error of estimate of B=0.009, Beta=0.025, t=0.133, p=0.894, 95% CI of B: \[-0.016, 0.018\]~Contrast between the high strain magnitude group and the control group: B=0.001, Std. Error of estimate of B=0.008, Beta=0.012, t=0.063, p=0.950, 95% CI of B: \[-0.016, 0.017\]"|||0.991
71106210|NCT04211363|141719296|SUPERIORITY||Odds Ratio (OR)|1.76||||0.1197|TWO_SIDED|95.0|0.98|3.19|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|WI-NRS Success at Week 2 Odds Ratio||3.19|0.98|0.1197
71106211|NCT04211363|141719296|SUPERIORITY||Odds Ratio (OR)|4.36|||<|0.0001|TWO_SIDED|95.0|2.31|8.26|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|WI-NRS Success at Week 4 Odds Ratio||8.26|2.31|<0.0001
71106212|NCT04211363|141719296|SUPERIORITY||Odds Ratio (OR)|7.84|||<|0.0001|TWO_SIDED|95.0|3.85|15.94|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|WI-NRS at Week 8 Odds Ratio||15.94|3.85|<0.0001
71106213|NCT04211363|141719297|SUPERIORITY||Mean Difference (Final Values)|-25.83|||<|0.0001|TWO_SIDED|95.0|-31.7|-20.0|||ANCOVA|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|Comparison of change from baseline in PSD score at Week 4||-20.0|-31.7|<0.0001
71106214|NCT04211363|141719297|SUPERIORITY||Mean Difference (Final Values)|-30.9|||<|0.0001|TWO_SIDED|95.0|-37.2|-24.6|||ANCOVA|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|Comparison of change from baseline in PSD score at Week 8||-24.6|-37.2|<0.0001
70932340|NCT02307682|141364357|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-3.3|7.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||7.5|-3.3|
70932341|NCT02307682|141364357|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-6.2|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||5.1|-6.2|
71106215|NCT03097289|141719298|NON_INFERIORITY|"The acceptance criterion for the recovery (%) of platelets is the demonstration of non-inferiority by the rejection of the Null Hypothesis (H0) defined by the following hypotheses: Null Hypothesis H0: μd ≤ 0 where μd=μT-0.66\*μC Alternate Hypothesis H1: μd \>~Let Xi = (XTi-0.66\*XCi) be a difference if recovery for patient i. The sample mean and standard deviations of these observed differences will be used to construct the lower limit of a 1-sided 97.5% confidence interval."|Mean Difference (Final Values)|8.18|||||ONE_SIDED|97.5|4.03||||||||||4.03|
71106216|NCT03097289|141719299|NON_INFERIORITY|"The acceptance criterion for the survival (days) of platelets is the demonstration of non inferiority by the rejection of the null hypothesis (H0) defined by the following hypotheses:~Null Hypothesis H0: μd ≤ 0 where μd = μT-0.58 × μC Alternate Hypothesis H1: μd \> 0"|Mean Difference (Final Values)|0.8|||||ONE_SIDED|97.5|0.39||||||||||0.39|
71106217|NCT01911260|141719304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_DEVIATION|2.0|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|In intragroup of supplementation (zinc or placebo) we used the t-test for dependent samples in order to compare growth over time.||"Null Hypothesis: There isn't difference in the HAZ mean difference between children with Growth Deficit who received zinc amino acid or placebo.~We attributed α=0.05, β=0.20, and power=0.80."||||<0.05
71106218|NCT01911260|141719304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_DEVIATION|2.0|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|In intragroup of supplementation (zinc or placebo) we used the t-test for dependent samples in order to compare growth over time.||"Null Hypothesis: There isn't difference in the HAZ mean difference between children with Normal Height who received zinc amino acid or placebo.~We attributed α=0.05, β=0.20, and power=0.80."||||<0.05
71106219|NCT01734902|141719309|EQUIVALENCE|The statistical model, analysis of variance (ANOVA) on the logarithmic scale includes effects: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subject within sequences' was considered as random, whereas the other effects were considered as fixed.|Adjusted gMean ratio T/R (%)|86.97|STANDARD_ERROR_OF_MEAN|35.6|||TWO_SIDED|90.0|74.046|102.151|||||Standard error of the mean is actually intra-individual geometric coefficient variance \[%\]. Statistical analysis is based on PKS which includes 27 subjects.|||102.151|74.046|
70932342|NCT02307682|141364357|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-6.4|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||5.5|-6.4|
70932343|NCT02307682|141364357|OTHER||Difference in proportions|3.3|||||TWO_SIDED|95.0|-2.2|8.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||8.7|-2.2|
70932344|NCT02307682|141364357|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-3.2|7.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||7.4|-3.2|
70932345|NCT02307682|141364357|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-3.5|8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||8.1|-3.5|
70932346|NCT02307682|141364357|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-5.8|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||5.8|-5.8|
70932347|NCT02307682|141364357|OTHER||Difference in proportions|-1.5|||||TWO_SIDED|95.0|-6.6|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.8|-6.6|
70932348|NCT02307682|141364357|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-5.8|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||5.1|-5.8|
70932349|NCT02307682|141364357|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-6.4|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.1|-6.4|
70932350|NCT02307682|141364357|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-8.7|2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||2.6|-8.7|
70932351|NCT02307682|141364357|OTHER||Difference in proportions|5.5|||||TWO_SIDED|95.0|0.3|10.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||10.7|0.3|
71052746|NCT04135196|141610046|OTHER|||||||0.018|||||||Regression, Linear|||The null hypothesis was that change in UD ecBMC was not proportional to strain rate. Raw change in ecBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.216, F=4.548, df1=2, df2=33, p=0.018~Contrast between the low strain rate group and the control group: B=0.029, Std. Error of estimate of B=0.011, Beta=0.455, t=2.607, p=0.014, 95% CI of B: \[0.006, 0.052\]~Contrast between the high strain rate group and the control group: B=0.029, Std. Error of estimate of B=0.011, Beta=0.447, t=2.563, p=0.015, 95% CI of B: \[0.006, 0.052\]"|||0.018
71052747|NCT04135196|141610047|OTHER|||||||0.153|||||||Regression, Linear|||The null hypothesis was that change in UD tBMC was not proportional to strain magnitude. Raw change in tBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.090, F=1.968, df1=2, df2=40, p=0.153~Contrast between the low strain magnitude group and the control group: B=0.007, Std. Error of estimate of B=0.003, Beta=0.352, t=1.973, p=0.055, 95% CI of B: \[0.000, 0.013\]~Contrast between the high strain magnitude group and the control group: B=0.003, Std. Error of estimate of B=0.003, Beta=0.156, t=0.874, p=0.387, 95% CI of B: \[-0.004, 0.009\]"|||0.153
71052748|NCT04135196|141610047|OTHER|||||||0.001|||||||Regression, Linear|||The null hypothesis was that change in UD tBMC was not proportional to strain rate. Raw change in tBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.331, F=8.152, df1=2, df2=33, p=0.001~Contrast between the low strain rate group and the control group: B=0.012, Std. Error of estimate of B=0.004, Beta=0.473, t=2.930, p=0.006, 95% CI of B: \[0.004, 0.020\]~Contrast between the high strain rate group and the control group: B=0.016, Std. Error of estimate of B=0.004, Beta=0.617, t=3.828, p=0.001, 95% CI of B: \[0.008, 0.025\]"|||0.001
71052749|NCT04135196|141610048|OTHER|||||||0.84|||||||Regression, Linear|||The null hypothesis was that change in UD iBMD was not proportional to strain magnitude. Raw change in iBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.009, F=0.176, df1=2, df2=40, p=0.840~Contrast between the low strain magnitude group and the control group: B=0.001, Std. Error of estimate of B=0.001, Beta=0.091, t=0.489, p=0.628, 95% CI of B: \[-0.002, 0.003\]~Contrast between the high strain magnitude group and the control group: B=0.001, Std. Error of estimate of B=0.001, Beta=0.101, t=0.544, p=0.589, 95% CI of B: \[-0.002, 0.003\]"|||0.840
71079501|NCT00482170|141666455|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32|||<|0.001|TWO_SIDED|95.0|0.22|0.46||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.46|0.22|<0.001
71020163|NCT02609178|141547313|NON_INFERIORITY_OR_EQUIVALENCE|Using G\*power 3.1.7, setting α at 0.05, (1- β) at 0.8, the number of the subjects enrolled could reach the actual power as 0.8.||||||0.003||||||Alpha value was set at 0.05.|ANOVA|||||||0.003
71020164|NCT02609178|141547313|NON_INFERIORITY_OR_EQUIVALENCE|stated above in statistical analysis 1||||||0.366||||||Alpha value was set at 0.05.|Tukey's multiple comparison test|||||||0.366
71020165|NCT02609178|141547313|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.002||||||Alpha value was set at 0.05.|Tukey's multiple comparison test|||||||0.002
71020166|NCT02609178|141547313|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.054||||||Alpha value was set at 0.05.|Tukey's multiple comparison test|||||||0.054
71020167|NCT02609178|141547314|NON_INFERIORITY_OR_EQUIVALENCE|Using G\*power 3.1.7, setting α at 0.05, (1- β) at 0.8, the number of the subjects enrolled could reach the actual power as 0.8.||||||0.006||||||alpha value was set at 0.05|Kruskal-Wallis|||||||0.006
71020168|NCT02609178|141547314|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistic analysis 1.||||||0.739||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.739
71020169|NCT02609178|141547314|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.03||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.03
71020170|NCT02609178|141547314|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.009||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.009
71020171|NCT02609178|141547315|NON_INFERIORITY_OR_EQUIVALENCE|Using G\*power 3.1.7, setting α at 0.05, (1- β) at 0.8, the number of the subjects enrolled could reach the actual power as 0.8.||||||0.001||||||alpha value was set at 0.05|Kruskal-Wallis|||||||0.001
71020172|NCT02609178|141547315|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.579||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.579
71020173|NCT02609178|141547315|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.001||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.001
71020174|NCT02609178|141547315|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.002||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.002
71020175|NCT02609178|141547316|NON_INFERIORITY_OR_EQUIVALENCE|Using G\*power 3.1.7, setting α at 0.05, (1- β) at 0.8, the number of the subjects enrolled could reach the actual power as 0.8.||||||0.007||||||alpha value was set at 0.05|ANOVA|||||||0.007
71020176|NCT02609178|141547316|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.308||||||Alpha value was set at 0.05.|Tukey's multiple comparison test|||||||0.308
71020177|NCT02609178|141547316|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.005||||||Alpha value was set at 0.05.|Tukey's multiple comparison test|||||||0.005
71106220|NCT01734902|141719310|EQUIVALENCE|The statistical model, analysis of variance (ANOVA) on the logarithmic scale includes effects: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subject within sequences' was considered as random, whereas the other effects were considered as fixed.|Adjusted gMean ratio T/R (%)|89.05|STANDARD_ERROR_OF_MEAN|31.2|||TWO_SIDED|90.0|77.26|102.62|||||Standard error of the mean is actually intra-individual geometric coefficient variance \[%\]. Statistical analysis is based on PKS which includes 27 subjects.|||102.62|77.26|
71106221|NCT01734902|141719311|EQUIVALENCE|The statistical model, analysis of variance (ANOVA) on the logarithmic scale includes effects: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subject within sequences' was considered as random, whereas the other effects were considered as fixed.|Adjusted gMean ratio T/R [%]|90.03|STANDARD_ERROR_OF_MEAN|29.3|||TWO_SIDED|90.0|78.78|102.88|||||Standard error of the mean is actually intra-individual geometric coefficient variance \[%\]. Statistical analysis is based on PKS which includes 27 subjects.|||102.88|78.78|
71106222|NCT01959932|141719312|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|8.38|||<|0.001|TWO_SIDED|95.0|6.89|10.2||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||10.20|6.89|<0.001
71020178|NCT02609178|141547316|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.141||||||Alpha value was set at 0.05.|Tukey's multiple comparison test|||||||0.141
71020179|NCT01128153|141547317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.099|<|0.0001|TWO_SIDED|95.0|-0.86|-0.47|||ANCOVA||Adjusted mean treatment difference from the ANCOVA model (Saxagliptin - Placebo)|||-0.47|-0.86|<0.0001
71020180|NCT01128153|141547318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.74|STANDARD_ERROR_OF_MEAN|7.667||0.0301|TWO_SIDED|95.0|-31.85|-1.62|||ANCOVA||Adjusted mean treatment difference from the ANCOVA model (Saxagliptin - Placebo)|||-1.62|-31.85|0.0301
71020181|NCT01128153|141547319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.426||0.0301|TWO_SIDED|95.0|-1.77|-0.09|||ANCOVA||Adjusted mean treatment difference from the ANCOVA model (Saxagliptin - Placebo)|||-0.09|-1.77|0.0301
71020182|NCT01128153|141547320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|4.595||0.0868|TWO_SIDED|95.0|-16.96|1.15|||ANCOVA||Adjusted mean treatment difference from the ANCOVA model (Saxagliptin - Placebo)|||1.15|-16.96|0.0868
71020183|NCT01128153|141547321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.255||0.0868|TWO_SIDED|95.0|-0.94|0.06|||ANCOVA||Adjusted mean treatment difference from the ANCOVA model (Saxagliptin - Placebo)|||0.06|-0.94|0.0868
71020184|NCT01128153|141547322|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.006|||<|0.0001|TWO_SIDED|95.0|3.852|21.05|||ANCOVA||Estimated Odds Ratio from the logistic regression model (Saxa/Placebo)|||21.05|3.852|<0.0001
71020185|NCT01347879|141547346|SUPERIORITY_OR_OTHER||Difference in least square means|-7.35||||0.006|TWO_SIDED|95.0|-12.5|-2.2|||ANCOVA|Lesion count at baseline and center as covariates||||-2.2|-12.5|0.006
71020186|NCT01347879|141547347|SUPERIORITY_OR_OTHER||Difference in least square means|-0.6||||0.8527|TWO_SIDED|95.0|-6.6|5.5|||ANCOVA|Lesion count at baseline and center as covariates||||5.5|-6.6|0.8527
71020187|NCT01347879|141547348|SUPERIORITY_OR_OTHER||Difference in least square means|-20.0||||0.0032|TWO_SIDED|95.0|-33.2|-6.8|||ANCOVA|Lesion count at baseline and center as covariates||||-6.8|-33.2|0.0032
71020188|NCT01347879|141547349|SUPERIORITY_OR_OTHER|||||||0.0125||95.0|||||Regression, Logistic|||||||0.0125
71020189|NCT01347879|141547354|SUPERIORITY_OR_OTHER||Difference in least square means|-2.56||||0.7161|TWO_SIDED|95.0|-16.5|11.3|||ANCOVA|Lesion count at baseline and center as covariate||||11.3|-16.5|0.7161
71020190|NCT00068770|141547360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5|STANDARD_DEVIATION|1.0||0.82|TWO_SIDED|95.0|1.5|5.5||not adjusted|t-test, 2 sided|||two independent group comparisons||5.5|1.5|0.82
71020191|NCT00068770|141547361|NON_INFERIORITY_OR_EQUIVALENCE|equivalence analysis|Hazard Ratio (HR)|2.7|STANDARD_DEVIATION|1.8||0.11|TWO_SIDED|95.0|1.1|6.3|||Log Rank|||||6.3|1.1|0.11
71020192|NCT00996918|141547364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.39|TWO_SIDED|95.0|-4.29|1.68|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 13.~Results are from a restricted maximum likelihood (REML)-based mixed model for repeated measures (MMRM) with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.68|-4.29|0.390
71020193|NCT00996918|141547364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.264|TWO_SIDED|95.0|-1.37|4.97|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 13.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.97|-1.37|0.264
71020194|NCT00996918|141547364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51||||0.357|TWO_SIDED|95.0|-4.74|1.72|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.72|-4.74|0.357
71020195|NCT00996918|141547364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.981|TWO_SIDED|95.0|-3.5|3.42|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.42|-3.50|0.981
71106223|NCT01959932|141719313|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS mean ratio|41.63|||<|0.001|TWO_SIDED|95.0|37.75|45.91||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on 3-HPMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||45.91|37.75|<0.001
71106224|NCT01959932|141719314|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|5.99|||<|0.001|TWO_SIDED|95.0|5.21|6.87||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on S-PMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||6.87|5.21|<0.001
71020196|NCT00996918|141547364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95||||0.584|TWO_SIDED|95.0|-4.37|2.47|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 39.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.47|-4.37|0.584
71020197|NCT00996918|141547364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.58||||0.392|TWO_SIDED|95.0|-2.05|5.2|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 39.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.20|-2.05|0.392
71020198|NCT00996918|141547364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05||||0.345|TWO_SIDED|95.0|-6.34|2.24|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.24|-6.34|0.345
71020199|NCT00996918|141547364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.922|TWO_SIDED|95.0|-4.73|4.28|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.28|-4.73|0.922
71020200|NCT00996918|141547364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.44||||0.384|TWO_SIDED|95.0|-7.97|3.1|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.10|-7.97|0.384
71020201|NCT00996918|141547364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.961|TWO_SIDED|95.0|-6.08|5.78|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.78|-6.08|0.961
71020202|NCT00996918|141547365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.837|TWO_SIDED|95.0|-1.91|2.35|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 13.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.35|-1.91|0.837
71020203|NCT00996918|141547365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.14||||0.064|TWO_SIDED|95.0|-0.13|4.41|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 13.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.41|-0.13|0.064
71020204|NCT00996918|141547365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.99|TWO_SIDED|95.0|-2.32|2.35|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.35|-2.32|0.990
71020205|NCT00996918|141547365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.817|TWO_SIDED|95.0|-2.22|2.82|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.82|-2.22|0.817
71020206|NCT00996918|141547365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.697|TWO_SIDED|95.0|-2.04|3.05|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 39.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.05|-2.04|0.697
71020207|NCT00996918|141547365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.93||||0.158|TWO_SIDED|95.0|-0.76|4.63|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 39.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.63|-0.76|0.158
71020208|NCT00996918|141547365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.829|TWO_SIDED|95.0|-4.06|3.26|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.26|-4.06|0.829
71020209|NCT00996918|141547365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.95|TWO_SIDED|95.0|-3.69|3.93|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.93|-3.69|0.950
71020210|NCT00996918|141547365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.816|TWO_SIDED|95.0|-5.35|4.23|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.23|-5.35|0.816
71020211|NCT00996918|141547365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82||||0.751|TWO_SIDED|95.0|-4.32|5.96|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.96|-4.32|0.751
71020212|NCT00996918|141547366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.967|TWO_SIDED|95.0|-7.22|7.53|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 13.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||7.53|-7.22|0.967
71020213|NCT00996918|141547366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.13||||0.593|TWO_SIDED|95.0|-5.72|9.98|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 13.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||9.98|-5.72|0.593
71020214|NCT00996918|141547366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.968|TWO_SIDED|95.0|-7.32|7.62|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||7.62|-7.32|0.968
71052750|NCT04135196|141610048|OTHER||||||<|0.001|||||||Regression, Linear|||The null hypothesis was that change in UD iBMD was not proportional to strain rate. Raw change in iBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.563, F=21.225, df1=2, df2=33, p=\<0.001~Contrast between the low strain rate group and the control group: B=0.009, Std. Error of estimate of B=0.002, Beta=0.739, t=5.669, p=\<0.001, 95% CI of B: \[0.005, 0.012\]~Contrast between the high strain rate group and the control group: B=0.008, Std. Error of estimate of B=0.002, Beta=0.716, t=5.495, p=\<0.001, 95% CI of B: \[0.005, 0.012\]"|||<0.001
71020215|NCT00996918|141547366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.92||||0.473|TWO_SIDED|95.0|-10.92|5.08|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.08|-10.92|0.473
71020216|NCT00996918|141547366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.95||||0.63|TWO_SIDED|95.0|-9.91|6.02|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 39.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||6.02|-9.91|0.630
71052751|NCT04135196|141610049|OTHER|||||||0.202|||||||Regression, Linear|||The null hypothesis was that change in UD cBMD was not proportional to strain magnitude. Raw change in cBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.077, F=1.665, df1=2, df2=40, p=0.202~Contrast between the low strain magnitude group and the control group: B=-0.005, Std. Error of estimate of B=0.003, Beta=-0.303, t=-1.689, p=0.099, 95% CI of B: \[-0.012, 0.001\]~Contrast between the high strain magnitude group and the control group: B=-0.004, Std. Error of estimate of B=0.003, Beta=-0.266, t=-1.484, p=0.146, 95% CI of B: \[-0.010, 0.002\]"|||0.202
71052752|NCT04135196|141610049|OTHER|||||||0.381|||||||Regression, Linear|||The null hypothesis was that change in UD cBMD was not proportional to strain rate. Raw change in cBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.057, F=0.995, df1=2, df2=33, p=0.381~Contrast between the low strain rate group and the control group: B=0.004, Std. Error of estimate of B=0.003, Beta=0.254, t=1.327, p=0.194, 95% CI of B: \[-0.002, 0.011\]~Contrast between the high strain rate group and the control group: B=0.001, Std. Error of estimate of B=0.003, Beta=0.038, t=0.200, p=0.843, 95% CI of B: \[-0.006, 0.008\]"|||0.381
71052753|NCT04135196|141610050|OTHER|||||||0.697|||||||Regression, Linear|||The null hypothesis was that change in UD ecBMD was not proportional to strain magnitude. Raw change in ecBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.018, F=0.365, df1=2, df2=40, p=0.697~Contrast between the low strain magnitude group and the control group: B=-0.004, Std. Error of estimate of B=0.004, Beta=-0.158, t=-0.854, p=0.398, 95% CI of B: \[-0.012, 0.005\]~Contrast between the high strain magnitude group and the control group: B=-0.002, Std. Error of estimate of B=0.004, Beta=-0.078, t=-0.423, p=0.675, 95% CI of B: \[-0.010, 0.006\]"|||0.697
71052754|NCT04135196|141610050|OTHER|||||||0.018|||||||Regression, Linear|||The null hypothesis was that change in UD ecBMD was not proportional to strain rate. Raw change in ecBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.215, F=4.516, df1=2, df2=33, p=0.018~Contrast between the low strain rate group and the control group: B=0.014, Std. Error of estimate of B=0.005, Beta=0.484, t=2.773, p=0.009, 95% CI of B: \[0.004, 0.0524\]~Contrast between the high strain rate group and the control group: B=0.012, Std. Error of estimate of B=0.005, Beta=0.406, t=2.325, p=0.026, 95% CI of B: \[0.001, 0.022\]"|||0.018
71052755|NCT04135196|141610051|OTHER|||||||0.073|||||||Regression, Linear|||The null hypothesis was that change in UD tBMD was not proportional to strain magnitude. Raw change in tBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.123, F=2.799, df1=2, df2=40, p=0.073~Contrast between the low strain magnitude group and the control group: B=0.003, Std. Error of estimate of B=0.001, Beta=0.413, t=2.361, p=0.023, 95% CI of B: \[0.000, 0.006\]~Contrast between the high strain magnitude group and the control group: B=0.002, Std. Error of estimate of B=0.001, Beta=0.198, t=1.129, p=0.265, 95% CI of B: \[-0.001, 0.004\]"|||0.073
71052756|NCT04135196|141610051|OTHER||||||<|0.001|||||||Regression, Linear|||The null hypothesis was that change in UD tBMD was not proportional to strain rate. Raw change in tBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.480, F=15.256, df1=2, df2=33, p=\<0.001~Contrast between the low strain rate group and the control group: B=0.008, Std. Error of estimate of B=0.002, Beta=0.590, t=4.153, p=\<0.001, 95% CI of B: \[0.004, 0.012\]~Contrast between the high strain rate group and the control group: B=0.001, Std. Error of estimate of B=0.002, Beta=0.734, t=5.164, p=\<0.001, 95% CI of B: \[0.006, 0.014\]"|||<0.001
71020217|NCT00996918|141547366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.53||||0.293|TWO_SIDED|95.0|-13.02|3.95|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 39.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.95|-13.02|0.293
71020218|NCT00996918|141547366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.53||||0.733|TWO_SIDED|95.0|-7.28|10.33|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||10.33|-7.28|0.733
71020219|NCT00996918|141547366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.81||||0.55|TWO_SIDED|95.0|-12.06|6.45|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||6.45|-12.06|0.550
71020220|NCT00996918|141547366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73||||0.902|TWO_SIDED|95.0|-11.04|12.5|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||12.50|-11.04|0.902
71020221|NCT00996918|141547366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.07||||0.43|TWO_SIDED|95.0|-17.75|7.61|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||7.61|-17.75|0.430
71052757|NCT04135196|141610052|OTHER|||||||0.101|||||||Regression, Linear|||The null hypothesis was that change in UD iBV was not proportional to strain magnitude. Raw change in iBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.108, F=2.428, df1=2, df2=40, p=0.101~Contrast between the low strain magnitude group and the control group: B=0.053, Std. Error of estimate of B=0.024, Beta=0.388, t=2.200, p=0.034, 95% CI of B: \[0.004, 0.101\]~Contrast between the high strain magnitude group and the control group: B=0.029, Std. Error of estimate of B=0.022, Beta=0.226, t=1.280, p=0.208, 95% CI of B: \[-0.017, 0.074\]"|||0.101
71052758|NCT04135196|141610052|OTHER|||||||0.344|||||||Regression, Linear|||The null hypothesis was that change in UD iBV was not proportional to strain rate. Raw change in iBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.063, F=01.103, df1=2, df2=33, p=0.344~Contrast between the low strain rate group and the control group: B=0.015, Std. Error of estimate of B=0.025, Beta=0.113, t=0.595, p=0.556, 95% CI of B: \[-0.036, 0.065\]~Contrast between the high strain rate group and the control group: B=0.038, Std. Error of estimate of B=0.025, Beta=0.283, t=1.481, p=0.148, 95% CI of B: \[-0.014, 0.089\]"|||0.344
70932352|NCT02307682|141364357|OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-3.2|7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||7.2|-3.2|
70932353|NCT02307682|141364357|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-6.1|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||4.7|-6.1|
70932354|NCT02307682|141364357|OTHER||Difference in proportions|-3.4|||||TWO_SIDED|95.0|-9.0|1.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||1.9|-9.0|
70932355|NCT02307682|141364357|OTHER||Difference in proportions|3.1|||||TWO_SIDED|95.0|-1.9|8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||8.1|-1.9|
70932356|NCT02307682|141364357|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-3.9|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||6.4|-3.9|
71052759|NCT04135196|141610053|OTHER|||||||0.676|||||||Regression, Linear|||The null hypothesis was that change in UD cBV was not proportional to strain magnitude. Raw change in cBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.019, F=0.395, df1=2, df2=40, p=0.676~Contrast between the low strain magnitude group and the control group: B=0.012, Std. Error of estimate of B=0.015, Beta=0.146, t=0.787, p=0.436, 95% CI of B: \[-0.019, 0.042\]~Contrast between the high strain magnitude group and the control group: B=0.001, Std. Error of estimate of B=0.014, Beta=0.013, t=0.070, p=0.945, 95% CI of B: \[-0.028, 0.029\]"|||0.676
71052760|NCT04135196|141610053|OTHER|||||||0.289|||||||Regression, Linear|||The null hypothesis was that change in UD cBV was not proportional to strain rate. Raw change in cBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|Overall model fit: R\^2=0.072, F=1.288, df1=2, df2=33, p=0.289 Contrast between the low strain rate group and the control group: B=0.014, Std. Error of estimate of B=0.018, Beta=0.154, t=0.814, p=0.422, 95% CI of B: \[-0.022, 0.051\] Contrast between the high strain rate group and the control group: B=0.029, Std. Error of estimate of B=0.018, Beta=0.304, t=1.604, p=0.118, 95% CI of B: \[-0.008, 0.066\]|||0.289
71079502|NCT00482170|141666455|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.38|||<|0.001|TWO_SIDED|95.0|0.26|0.56||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.56|0.26|<0.001
71079503|NCT00482170|141666455|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41|||<|0.001|TWO_SIDED|95.0|0.28|0.58||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||0.58|0.28|<0.001
71079504|NCT00482170|141666456|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.47|TWO_SIDED|95.0|0.6|1.26||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the first injection: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.26|0.60|0.470
71079505|NCT00482170|141666456|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.325|TWO_SIDED|95.0|0.57|1.2||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.20|0.57|0.325
71117612|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
71052761|NCT04135196|141610054|OTHER|||||||0.096|||||||Regression, Linear|||The null hypothesis was that change in UD ecBV was not proportional to strain magnitude. Raw change in ecBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.111, F=2.491, df1=2, df2=40, p=0.096~Contrast between the low strain magnitude group and the control group: B=0.026, Std. Error of estimate of B=0.012, Beta=0.391, t=2.222, p=0.032, 95% CI of B: \[0.032, 0.049\]~Contrast between the high strain magnitude group and the control group: B=0.015, Std. Error of estimate of B=0.011, Beta=0.240, t=1.362, p=0.181, 95% CI of B: \[-0.007, 0.037\]"|||0.096
71077909|NCT02913105|141664398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.9892|TWO_SIDED|90.0|0.87|1.15|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 112 (EOS)||1.15|0.87|0.9892
70932357|NCT02307682|141364357|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-4.7|6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.6|-4.7|
71077910|NCT02913105|141664399|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.91||||0.0005|TWO_SIDED|90.0|0.87|0.95|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 7||0.95|0.87|0.0005
71077911|NCT02913105|141664399|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.89||||0.0005|TWO_SIDED|90.0|0.84|0.94|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 14||0.94|0.84|0.0005
71077912|NCT02913105|141664399|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.91||||0.0062|TWO_SIDED|90.0|0.86|0.96|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 28||0.96|0.86|0.0062
71077913|NCT02913105|141664399|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.1214|TWO_SIDED|90.0|0.89|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 42||1.00|0.89|0.1214
71077914|NCT02913105|141664399|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.9||||0.0043|TWO_SIDED|90.0|0.84|0.95|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 56||0.95|0.84|0.0043
71077915|NCT02913105|141664399|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.95||||0.2615|TWO_SIDED|90.0|0.89|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 84||1.02|0.89|0.2615
71077916|NCT02913105|141664399|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.1331|TWO_SIDED|90.0|0.88|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 112 (EOS)||1.01|0.88|0.1331
71077917|NCT02913105|141664399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.85|||<|0.0001|TWO_SIDED|90.0|0.81|0.89|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 7||0.89|0.81|<.0001
71020222|NCT00996918|141547367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.683|TWO_SIDED|95.0|-6.01|3.95|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 13.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.95|-6.01|0.683
71020223|NCT00996918|141547367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.69||||0.177|TWO_SIDED|95.0|-1.68|9.06|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 13.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||9.06|-1.68|0.177
71052762|NCT04135196|141610054|OTHER|||||||0.344|||||||Regression, Linear|||The null hypothesis was that change in UD ecBV was not proportional to strain rate. Raw change in ecBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.063, F=1.103, df1=2, df2=33, p=0.344~Contrast between the low strain rate group and the control group: B=0.014, Std. Error of estimate of B=0.015, Beta=0.113, t=0.595, p=0.556, 95% CI of B: \[-0.036, 0.065\]~Contrast between the high strain rate group and the control group: B=0.038, Std. Error of estimate of B=0.025, Beta=0.283, t=1.481, p=0.148, 95% CI of B: \[-0.014, 0.089\]"|||0.344
71052763|NCT04135196|141610055|OTHER|||||||0.332|||||||Regression, Linear|||The null hypothesis was that change in UD tBV was not proportional to strain magnitude. Raw change in tBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.054, F=1.132, df1=2, df2=40, p=0.332~Contrast between the low strain magnitude group and the control group: B=0.016, Std. Error of estimate of B=0.011, Beta=0.271, t=1.493, p=0.143, 95% CI of B: \[-0.006, 0.039\]~Contrast between the high strain magnitude group and the control group: B=0.007, Std. Error of estimate of B=0.010, Beta=0.115, t=635, p=0.529, 95% CI of B: \[-0.014, 0.028\]"|||0.332
71052764|NCT04135196|141610055|OTHER|||||||0.399|||||||Regression, Linear|||The null hypothesis was that change in UD tBV was not proportional to strain rate. Raw change in tBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.054, F=0.946, df1=2, df2=33, p=0.399~Contrast between the low strain rate group and the control group: B=0.008, Std. Error of estimate of B=0.012, Beta=0.119, t=0.619, p=0.540, 95% CI of B: \[-0.017, 0.032\]~Contrast between the high strain rate group and the control group: B=0.017, Std. Error of estimate of B=0.012, Beta=0.264, t=1.375, p=0.178, 95% CI of B: \[-0.008, 0.042\]"|||0.399
71052765|NCT04135196|141610056|OTHER|||||||||||||||||The null hypothesis was that change in cortical thickness was not proportional to strain magnitude. At each time point, raw change relative to baseline was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"At each time point, the overall fit of the linear regression model was assessed with an F-test of overall significance. Additionally, the significance of each coefficient representing contrasts between each experimental group and the control group was assessed using t-tests.~There were no significant relationships found between change in cortical thickness and strain magnitude group at any time point (p\>0.05)."|||
71052766|NCT04135196|141610056|OTHER|||||||||||||||||The null hypothesis was that change in cortical thickness was not proportional to strain rate. At each time point, raw change relative to baseline was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"At each time point, the overall fit of the linear regression model was assessed with an F-test of overall significance. Additionally, the significance of each coefficient representing contrasts between each experimental group and the control group was assessed using t-tests.~At 3 months, there was a significant overall linear relationship between change in cortical thickness and strain rate group. Additionally, the coefficient representing the contrast between the control group and the high strain rate group was also significant. All other comparisons were not statistically significant (p\>0.05).~Stats for 3 months:~Overall model fit: R\^2=0.258, F=4.519, df1=2, df2=26, p=0.021~Contrast between the high strain rate group and the control group: B=0.036, Std. Error of estimate of B=0.012, Beta=0.574, t=2.967, p=0.006, 95% CI of B: \[0.011, 0.061\]"|||
71052767|NCT04135196|141610057|OTHER|||||||||||||||||The null hypothesis was that change in bone volume fraction (BV/TV) was not proportional to strain magnitude. At each time point, raw change relative to baseline was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"At each time point, the overall fit of the linear regression model was assessed with an F-test of overall significance. Additionally, the significance of each coefficient representing contrasts between each experimental group and the control group was assessed using t-tests.~At 9 months, there was a significant overall linear relationship between change in BV/TV and strain magnitude group. Additionally, the coefficient representing the contrast between the control group and the low strain magnitude group was also significant. All other comparisons were not statistically significant (p\>0.05).~Stats for 9 months:~Overall model fit: R\^2=0.240, F=5.057, df1=2, df2=32, p=0.012~Contrast between the low strain magnitude group and the control group: B=0.003, Std. Error of estimate of B=0.001, Beta=0.562, t=3.180, p=0.003, 95% CI of B: \[0.001, 0.006\]"|||
71052768|NCT04135196|141610057|OTHER||||||>|0.05|||||||Regression, Linear|||The null hypothesis was that change in bone volume fraction (BV/TV) was not proportional to strain rate. At each time point, raw change relative to baseline was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|At each time point, the overall fit of the linear regression model was assessed with an F-test of overall significance. Additionally, the significance of each coefficient representing contrasts between each experimental group and the control group was assessed using t-tests.|||>0.05
71052769|NCT03316378|141610083|SUPERIORITY||Mean Difference (Final Values)|73.8||||0.44|TWO_SIDED|||||Adjusted for multiple comparisons|ANOVA|||Specific Aim 1: Between groups||||0.44
71020224|NCT00996918|141547367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89||||0.734|TWO_SIDED|95.0|-6.03|4.25|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.25|-6.03|0.734
71020225|NCT00996918|141547367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.595|TWO_SIDED|95.0|-7.06|4.05|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.05|-7.06|0.595
71020226|NCT00996918|141547367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35||||0.409|TWO_SIDED|95.0|-7.95|3.24|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 39.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.24|-7.95|0.409
71020227|NCT00996918|141547367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.74||||0.368|TWO_SIDED|95.0|-8.73|3.24|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 39.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.24|-8.73|0.368
71020228|NCT00996918|141547367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.44||||0.458|TWO_SIDED|95.0|-4.01|8.89|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||8.89|-4.01|0.458
71020229|NCT00996918|141547367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04||||0.76|TWO_SIDED|95.0|-7.77|5.68|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.68|-7.77|0.760
71020230|NCT00996918|141547367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.09||||0.597|TWO_SIDED|95.0|-5.67|9.86|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||9.86|-5.67|0.597
71052770|NCT03316378|141610083|SUPERIORITY||Mean Difference (Final Values)|31.7||||0.08|TWO_SIDED|||||P-value adjusted for multiple comparisons|ANOVA|||Specific Aim 2: Effect of time||||0.08
71052771|NCT03316378|141610084|SUPERIORITY||Mean Difference (Final Values)|6.9|||<|0.001|TWO_SIDED|||||P-value adjusted for multiple comparisons|ANOVA|||Specific Aim 1: Between groups||||<0.001
71052772|NCT03316378|141610084|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.012|TWO_SIDED|||||P-value adjusted for multiple comparisons|ANOVA|||Specific Aim 2: Effect of time||||0.012
71052773|NCT03316378|141610085|SUPERIORITY||Mean Difference (Final Values)|0.15||||1|TWO_SIDED|||||P-value adjusted for multiple comparisons|ANOVA|||Specific Aim 1: Between groups||||1.0
71052774|NCT03316378|141610085|SUPERIORITY||Mean Difference (Final Values)|0.05||||1|TWO_SIDED|||||P-value adjusted for multiple comparisons|ANOVA|||Specific Aim 2: Effect of time||||1.0
71052775|NCT01629966|141610118|SUPERIORITY||Least Squares Mean Difference|-1.27||||0.083|TWO_SIDED|95.0|-2.71|0.17|||MMRM|||||0.17|-2.71|0.0830
71052776|NCT01629966|141610118|SUPERIORITY||Least Squares Mean Difference|-1.8||||0.0156|TWO_SIDED|95.0|-3.26|-0.34|||MMRM|||||-0.34|-3.26|0.0156
71052777|NCT01629966|141610119|SUPERIORITY||Least Squares Mean Difference|-1.37||||0.0536|TWO_SIDED|95.0|-2.75|0.02|||MMRM|||||0.02|-2.75|0.0536
71052778|NCT01629966|141610119|SUPERIORITY||Least Squares Mean Difference|-1.52||||0.0349|TWO_SIDED|95.0|-2.94|-0.11|||MMRM|||||-0.11|-2.94|0.0349
71052779|NCT04568031|141610135|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71052780|NCT04568031|141610135|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71052781|NCT04568031|141610140|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71052782|NCT04568031|141610140|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71052783|NCT04568031|141610143|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71052784|NCT04568031|141610143|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71052785|NCT04430855|141610147|SUPERIORITY||Response Rate Difference|13.3||||0.018|TWO_SIDED|95.0|-0.6|27.2|||Chi-squared||Response rate difference compared to historical placebo = upadacitinib 30 mg - historical placebo|The primary analysis compared the percentage of participants in the upadacitinib 30 mg treatment group who achieved HiSCR response to that of a prespecified, single historical placebo rate (25%). The historical placebo rate of 25% was assumed based on the corresponding response rates of placebo participants satisfying the same key eligibility criteria from the 2 adalimumab HS Phase 3 studies, Study M11-313 (NCT01468207) and Study M11-810 (NCT01468233).||27.2|-0.6|0.018
71020231|NCT00996918|141547367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.87||||0.501|TWO_SIDED|95.0|-11.24|5.5|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.50|-11.24|0.501
71020232|NCT00996918|141547368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.183|TWO_SIDED|95.0|-8.91|1.71|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.71|-8.91|0.183
70932358|NCT02307682|141364357|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-5.2|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.1|-5.2|
71020233|NCT00996918|141547368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.92|TWO_SIDED|95.0|-5.92|5.35|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.35|-5.92|0.920
71052786|NCT04430855|141610147|SUPERIORITY||Adjusted Response Rate Difference|9.2||||0.142|TWO_SIDED|95.0|-7.6|25.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline Hurley Stage \[Stage \< III, Stage III\] and prior TNF use \[Yes or No\])|Response rate difference = upadacitinib 30 mg - placebo (in-trial + synthetic)|As a supplemental analysis, the percentage of participants who achieved HiSCR at Week 12 was further analyzed by comparing upadacitinib with in-trial placebo participants combined with subjects with historical placebo HiSCR data pre-selected using propensity score matching from adalimumab studies M11-313 and M11-810 and risankizumab study M16-833 (NCT03926169), whose study populations, entry criteria and study designs were similar to this study. The placebo in-trial + synthetic HiSCR was 29.2%.||25.9|-7.6|0.142
71052787|NCT04430855|141610147|SUPERIORITY||Adjusted Response Rate Difference|14.7||||0.087|TWO_SIDED|95.0|-6.6|36.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline Hurley Stage \[Stage \< III, Stage III\] and prior TNF use \[Yes or No\])|Response rate difference = upadacitinib 30 mg - placebo|As an additional supplemental analysis, the percentage of participants who achieved HiSCR at Week 12 was also analyzed by comparing upadacitinib 30 mg with in-trial placebo participants.||36.0|-6.6|0.087
71052788|NCT04430855|141610148|SUPERIORITY||Response Rate Difference|13.9||||0.028|TWO_SIDED|95.0|-2.5|30.3|||Chi-squared||Response rate difference compared to historical placebo (upadacitinib 30 mg - historical placebo)|The primary analysis compared the percentage of participants in the upadacitinib 30 mg treatment group who achieved NRS30 response to that of a prespecified, single historical placebo rate (22.5%). The historical placebo rate of 22.5% was assumed based on the corresponding response rates of placebo participants satisfying the same key eligibility criteria from the 2 adalimumab HS Phase 3 studies, Study M11-313 (NCT01468207) and Study M11-810 (NCT01468233).||30.3|-2.5|0.028
71052789|NCT04430855|141610148|SUPERIORITY||Adjusted Response Rate Difference|4.5||||0.323|TWO_SIDED|95.0|-14.6|23.5||Cochran-Mantel-Haenszel test adjusted for strata (Baseline Hurley Stage \[Stage \< III, Stage III\] and prior TNF use \[Yes or No\])|Cochran-Mantel-Haenszel||Response rate difference = upadacitinib 30 mg - placebo (in-trial + synthetic)|As a supplemental analysis, the percentage of participants who achieved NRS30 at Week 12 was further analyzed by comparing upadacitinib with in-trial placebo participants combined with subjects with historical placebo NRS30 data pre-selected using propensity score matching from adalimumab studies M11-313 and M11-810 and risankizumab study M16-833 (NCT03926169), whose study populations, entry criteria and study designs were similar to this study. The placebo in-trial + synthetic NRS30 was 31.3%.||23.5|-14.6|0.323
71052790|NCT04430855|141610148|SUPERIORITY||Adjusted Response Rate Difference|2.2||||0.421|TWO_SIDED|95.0|-19.6|24.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline Hurley Stage \[Stage \< III, Stage III\] and prior TNF use \[Yes or No\])|Response rate difference = upadacitinib 30 mg - placebo|As an additional supplemental analysis, the percentage of participants who achieved NRS30 at Week 12 was also analyzed by comparing upadacitinib 30 mg with in-trial placebo participants.||24.0|-19.6|0.421
71052791|NCT00390221|141610149|SUPERIORITY_OR_OTHER||Rate Ratio|0.461|||<|0.0001|TWO_SIDED|95.0|0.318|0.668||adjusted for the number of relapses in the 1 year prior to study entry, baseline Expanded Disability Status Scale (\<=2.5 vs \> 2.5), and age (\<=35 vs \>35)|Negative Binomial Regression|||||0.668|0.318|<0.0001
71052792|NCT00390221|141610149|SUPERIORITY_OR_OTHER||Rate Ratio|0.503||||0.0002|TWO_SIDED|95.0|0.352|0.721||adjusted for the number of relapses in the 1 year prior to study entry, baseline Expanded Disability Status Scale (\<=2.5 vs \> 2.5), and age (\<=35 vs \>35)|Negative Binomial Regression|||||0.721|0.352|0.0002
71052793|NCT00390221|141610150|SUPERIORITY_OR_OTHER||Percent Reduction|78.44|||<|0.0001|TWO_SIDED|95.0|65.97|86.35|||Negative Binomial Regression|adjusted for the baseline number of Gd-enhancing lesions||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||86.35|65.97|<0.0001
71052794|NCT00390221|141610150|SUPERIORITY_OR_OTHER||Percent Reduction|69.47|||<|0.0001|TWO_SIDED|95.0|52.4|80.41|||Negative Binomial Regression|adjusted for the baseline number of Gd-enhancing lesions||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||80.41|52.40|<0.0001
71052795|NCT00390221|141610151|SUPERIORITY_OR_OTHER||Percent Reduction|78.73|||<|0.0001|TWO_SIDED|95.0|71.33|84.22|||Negative Binomial Regression|adjusted for baseline number of T2 lesions||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||84.22|71.33|<0.0001
71052796|NCT00390221|141610151|SUPERIORITY_OR_OTHER||Percent Reduction|70.23|||<|0.0001|TWO_SIDED|95.0|59.94|77.88|||Negative Binomial Regression|adjusted for baseline number of T2 lesions||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||77.88|59.94|<0.0001
71052797|NCT00390221|141610152|SUPERIORITY_OR_OTHER||Hazard Ratio|0.49||||0.0003|TWO_SIDED|95.0|0.33|0.72||Covariates included were number of relapses in the 1 year prior to study entry (p=0.001), baseline Expanded Disability Status Scale (\<=2.5 versus \>2.5, p=0.449), and age (\<=35 versus \>35, p=0.026).|Cox Proportional Hazard|||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||0.72|0.33|0.0003
71052798|NCT00390221|141610152|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.3|0.67||Covariates included were number of relapses in the 1 year prior to study entry (p=0.001), baseline Expanded Disability Status Scale (\<=2.5 versus \>2.5, p=0.449), and age (\<=35 versus \>35, p=0.026).|Cox Proportional Hazard|||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||0.67|0.30|<0.0001
71052799|NCT00390221|141610153|SUPERIORITY_OR_OTHER||Relative Mean Change|-1.93||||0.1284|TWO_SIDED|95.0|-4.42|0.56||Analysis of variance for difference between treatment groups, controlling for baseline score.|Analysis of Variance|||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||0.56|-4.42|0.1284
71052800|NCT00390221|141610153|SUPERIORITY_OR_OTHER||Relative Mean Change|-4.27||||0.0008|TWO_SIDED|95.0|-6.76|-1.78|||Analysis of Variance|Analysis of variance for difference between treatment groups, controlling for baseline score.||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||-1.78|-6.76|0.0008
71052801|NCT04682730|141610225|SUPERIORITY||Odds Ratio (OR)|0.8|STANDARD_ERROR_OF_MEAN|0.13||0.18|TWO_SIDED|95.0|0.58|1.11|||Mixed Models Analysis|||||1.11|0.58|0.18
71052802|NCT04682730|141610227|OTHER|single intervention group across 16 clinics|mean total program costs in 2021 dollars|7845.0|STANDARD_DEVIATION|2.0|||TWO_SIDED|95.0|6378.0|9312.0|||||An opportunity cost approach was used. Costs estimated: Develop workbook- guideline, EHR data analyses, survey, evidence review- \& print; facilitator training/delivery/program tailoring; staff time; implemented strategies; dental sealant placements.|Mean Total Program costs per clinic for the KPNW Dental system.||9312|6378|
71052803|NCT04682730|141610231|OTHER|single intervention group across 16 clinics|mean total costs/per clinic per sealant|1321.0|STANDARD_DEVIATION|1245.0|||TWO_SIDED|95.0|845.0|3208.0|||||Total cost per sealant calculated as quotient of total intervention costs ($125,521) \& total sealants placed (95), is = to mean cost/sealant across each clinic ($7845/5.938).|Mean Total Program costs per sealant per clinic for the KPNW Dental system.||3208|845|
71052804|NCT04682730|141610233|OTHER|descriptive analysis|percentage|100.0|||||TWO_SIDED||||||||||89/89 treatment plans completed by the end of the period.|||
71052805|NCT03258853|141610251|SUPERIORITY|||||||0.001|||||||paired 2-sided t-test|||||||0.001
71052806|NCT03258853|141610252|SUPERIORITY|||||||1||||||Secondary outcomes were adjusted for multiple comparisons|Wilcoxon signed rank test|||||||1.0
71052807|NCT03258853|141610253|SUPERIORITY|||||||0.04||||||Secondary outcomes are adjusted for multiple comparisons|paired 2-sided t-test|||||||0.04
71052808|NCT03258853|141610254|SUPERIORITY|||||||1||||||Adjusted for multiple comparisons|Wicoxon signed rank test|||||||1.0
71052809|NCT03258853|141610255|SUPERIORITY|||||||0.014||||||Adjusted for multiple comparisons|Wilcoxon signed rank test|||||||0.014
71052810|NCT03258853|141610256|SUPERIORITY|||||||0.014||||||Adjusted for multiple comparisons|Wilcoxon signed rank test|||||||0.014
71052811|NCT03258853|141610257|SUPERIORITY|||||||0.14||||||Adjusted for multiple comparisons|Wilcoxon signed rank test|||||||0.14
70932359|NCT02307682|141364357|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-3.3|7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||7.3|-3.3|
70932360|NCT02307682|141364357|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-5.7|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.8|-5.7|
71020234|NCT00996918|141547368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.99||||0.133|TWO_SIDED|95.0|-11.52|1.53|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.53|-11.52|0.133
71020235|NCT00996918|141547368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.34||||0.505|TWO_SIDED|95.0|-4.55|9.22|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||9.22|-4.55|0.505
71020236|NCT00996918|141547368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.86||||0.003|TWO_SIDED|95.0|-21.46|-4.25|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||-4.25|-21.46|0.003
71020237|NCT00996918|141547368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.47||||0.76|TWO_SIDED|95.0|-7.95|10.88|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||10.88|-7.95|0.760
71020238|NCT00996918|141547369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.08||||0.373|TWO_SIDED|95.0|-6.68|2.52|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.52|-6.68|0.373
71020239|NCT00996918|141547369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.677|TWO_SIDED|95.0|-5.92|3.86|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.86|-5.92|0.677
71020240|NCT00996918|141547369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.28|TWO_SIDED|95.0|-9.61|2.8|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.80|-9.61|0.280
71020241|NCT00996918|141547369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.95|TWO_SIDED|95.0|-6.34|6.76|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||6.76|-6.34|0.950
71020242|NCT00996918|141547369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.06||||0.13|TWO_SIDED|95.0|-23.16|3.05|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.05|-23.16|0.130
71020243|NCT00996918|141547369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.48||||0.732|TWO_SIDED|95.0|-11.97|16.94|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||16.94|-11.97|0.732
71052812|NCT03258853|141610258|SUPERIORITY|||||||1||||||Adjusted for multiple comparisons|Wilcoxon signed rank test|||||||1.0
71052813|NCT03258853|141610259|SUPERIORITY|||||||0.01|||||||Wilcoxon signed rank test|||||||0.01
71052814|NCT03258853|141610260|SUPERIORITY|||||||0.08|||||||McNemar|||||||0.08
70932361|NCT02307682|141364357|OTHER||Difference in proportions|3.9|||||TWO_SIDED|95.0|-1.7|9.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||9.7|-1.7|
70932362|NCT02307682|141364357|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-5.3|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||5.6|-5.3|
70932363|NCT02307682|141364357|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-1.3|8.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||8.9|-1.3|
70932364|NCT02307682|141364357|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-4.3|6.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||6.0|-4.3|
70932365|NCT02307682|141364357|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-6.4|5.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||5.2|-6.4|
70932366|NCT02307682|141364357|OTHER||Difference in proportions|-4.9|||||TWO_SIDED|95.0|-10.8|0.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||0.9|-10.8|
70932367|NCT02307682|141364358|OTHER||Difference in proportions|-2.3|||||TWO_SIDED|95.0|-7.7|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.6|-7.7|
70932368|NCT02307682|141364358|OTHER||Difference in proportions|-5.7|||||TWO_SIDED|95.0|-11.4|0.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||0.4|-11.4|
70932369|NCT02307682|141364358|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-9.3|1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.2|-9.3|
70932370|NCT02307682|141364358|OTHER||Difference in proportions|-4.4|||||TWO_SIDED|95.0|-9.8|1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.2|-9.8|
70932371|NCT02307682|141364358|OTHER||Difference in proportions|-6.5|||||TWO_SIDED|95.0|-11.5|-1.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-1.5|-11.5|
70932372|NCT02307682|141364358|OTHER||Difference in proportions|-7.6|||||TWO_SIDED|95.0|-12.8|-2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-2.3|-12.8|
70932373|NCT02307682|141364358|OTHER||Difference in proportions|-6.5|||||TWO_SIDED|95.0|-11.8|-1.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-1.1|-11.8|
70932374|NCT02307682|141364358|OTHER||Difference in proportions|-8.6|||||TWO_SIDED|95.0|-14.4|-2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-2.9|-14.4|
70932375|NCT02307682|141364358|OTHER||Difference in proportions|2.7|||||TWO_SIDED|95.0|-2.8|8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||8.3|-2.8|
71052815|NCT03258853|141610261|SUPERIORITY|||||||0.56|||||||McNemar|||||||0.56
71052816|NCT03258853|141610262|SUPERIORITY|||||||0.56|||||||McNemar|||||||0.56
71052817|NCT03258853|141610263|SUPERIORITY|||||||0.15|||||||McNemar|||||||0.15
71052818|NCT03564444|141610291|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-6.7|1.9||||||||1.9|-6.7|
71052819|NCT01540773|141610304|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
71052820|NCT01540773|141610305|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
71052821|NCT03753763|141610308|SUPERIORITY||Least square mean difference|0.1||||0.9697|TWO_SIDED|95.0|-6.3|6.5|||Mixed Models Analysis|A mixed-model repeated measures (MMRM) was used to analyze the change in anterior and lateral displacement from baseline||The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate.||6.5|-6.3|0.9697
71052822|NCT03753763|141610309|SUPERIORITY||least square mean difference|0.5||||0.7751|TWO_SIDED|95.0|-3.1|4.1||A mixed-model repeated measures (MMRM) was used to analyze the change in anterior and lateral displacement from baseline.|Mixed Models Analysis|||The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate||4.1|-3.1|0.7751
71052823|NCT03753763|141610310|SUPERIORITY||least square mean difference|0.2||||0.9076|TWO_SIDED|95.0|-3.3|3.7|||Mixed Models Analysis|A mixed-model repeated measures (MMRM) was used to analyze the change in from baseline in UMSARS Part II||The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate.||3.7|-3.3|0.9076
71052824|NCT03753763|141610311|SUPERIORITY||least square mean difference|-1.1||||0.5386|TWO_SIDED|95.0|-4.8|2.6|||Mixed Models Analysis|A mixed-model repeated measures (MMRM) was used to analyze the change in from baseline in UMSARS Part II.||The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate.||2.6|-4.8|0.5386
71052825|NCT03753763|141610312|SUPERIORITY||Least square mean difference|6.0||||0.3364|TWO_SIDED|95.0|-6.5|18.6|||Mixed Models Analysis|A mixed-model repeated measures (MMRM) was used to analyze the change in from baseline in MSA-QoL scale.||The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate.||18.6|-6.5|0.3364
71052826|NCT03753763|141610313|SUPERIORITY||Least square mean difference|0.2||||0.7574|TWO_SIDED|95.0|-1.1|1.5|||ANCOVA|||The ANCOVA included change from baseline as the response variable, treatment group as a factor, and baseline score as a covariate||1.5|-1.1|0.7574
71052827|NCT03753763|141610314|SUPERIORITY||Least square mean difference|0.8||||0.6393|TWO_SIDED|95.0|-2.5|4.0|||Mixed Models Analysis|A mixed-model repeated measures (MMRM) was used to analyze the change from baseline in UDRS.||The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate.||4.0|-2.5|0.6393
71052828|NCT03433755|141610317|SUPERIORITY||Treatment difference|-70.73|STANDARD_ERROR_OF_MEAN|3.65|<|0.0001|TWO_SIDED|95.0|-77.98|-63.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-63.48|-77.98|< 0.0001
71052829|NCT03433755|141610317|SUPERIORITY||Treatment difference|-69.74|STANDARD_ERROR_OF_MEAN|3.41|<|0.0001|TWO_SIDED|95.0|-76.51|-62.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-62.97|-76.51|< 0.0001
71052830|NCT03433755|141610318|SUPERIORITY||Treatment difference|-70.87|STANDARD_ERROR_OF_MEAN|4.33|<|0.0001|TWO_SIDED|95.0|-79.47|-62.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-62.27|-79.47|< 0.0001
71052831|NCT03433755|141610318|SUPERIORITY||Treatment difference|-65.81|STANDARD_ERROR_OF_MEAN|4.11|<|0.0001|TWO_SIDED|95.0|-73.97|-57.66||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-57.66|-73.97|< 0.0001
71052832|NCT03433755|141610319|SUPERIORITY||Treatment difference|-76.5|STANDARD_ERROR_OF_MEAN|5.1|<|0.0001|TWO_SIDED|95.0|-86.6|-66.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-66.4|-86.6|< 0.0001
71052833|NCT03433755|141610319|SUPERIORITY||Treatment difference|-77.2|STANDARD_ERROR_OF_MEAN|5.3|<|0.0001|TWO_SIDED|95.0|-87.7|-66.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-66.7|-87.7|< 0.0001
71052834|NCT03433755|141610320|SUPERIORITY||Treatment difference|-75.9|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001|TWO_SIDED|95.0|-87.1|-64.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-64.7|-87.1|< 0.0001
71052835|NCT03433755|141610320|SUPERIORITY||Treatment difference|-73.0|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001|TWO_SIDED|95.0|-84.1|-61.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-61.8|-84.1|< 0.0001
71052836|NCT03433755|141610321|SUPERIORITY||Treatment difference|-61.2|STANDARD_ERROR_OF_MEAN|3.44|<|0.0001|TWO_SIDED|95.0|-68.04|-54.37||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-54.37|-68.04|< 0.0001
70932376|NCT02307682|141364358|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-3.4|7.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||7.5|-3.4|
70932377|NCT02307682|141364358|OTHER||Difference in proportions|-4.6|||||TWO_SIDED|95.0|-9.7|0.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||0.9|-9.7|
71052837|NCT03433755|141610321|SUPERIORITY||Treatment difference|-62.15|STANDARD_ERROR_OF_MEAN|2.94|<|0.0001|TWO_SIDED|95.0|-67.97|-56.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-56.32|-67.97|< 0.0001
71052838|NCT03433755|141610322|SUPERIORITY||Treatment difference|-61.45|STANDARD_ERROR_OF_MEAN|3.93|<|0.0001|TWO_SIDED|95.0|-69.25|-53.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-53.65|-69.25|< 0.0001
70932378|NCT02307682|141364358|OTHER||Difference in proportions|-7.1|||||TWO_SIDED|95.0|-12.3|-1.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-1.3|-12.3|
70932379|NCT02307682|141364358|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-4.2|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||6.2|-4.2|
71052839|NCT03433755|141610322|SUPERIORITY||Treatment difference|-56.65|STANDARD_ERROR_OF_MEAN|3.54|<|0.0001|TWO_SIDED|95.0|-63.66|-49.63||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-49.63|-63.66|< 0.0001
71052840|NCT03433755|141610323|SUPERIORITY||Treatment Difference|-56.26|STANDARD_ERROR_OF_MEAN|3.12|<|0.0001|TWO_SIDED|95.0|-62.44|-50.07||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-50.07|-62.44|< 0.0001
71052841|NCT03433755|141610323|SUPERIORITY||Treatment Difference|-57.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|95.0|-62.35|-51.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-51.65|-62.35|< 0.0001
71052842|NCT03433755|141610324|SUPERIORITY||Treatment difference|-55.69|STANDARD_ERROR_OF_MEAN|3.67|<|0.0001|TWO_SIDED|95.0|-62.98|-48.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-48.41|-62.98|< 0.0001
71052843|NCT03433755|141610324|SUPERIORITY||Treatment difference|-51.21|STANDARD_ERROR_OF_MEAN|3.45|<|0.0001|TWO_SIDED|95.0|-58.06|-44.37||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-44.37|-58.06|< 0.0001
71052844|NCT03433755|141610325|SUPERIORITY||Treatment difference|-42.74|STANDARD_ERROR_OF_MEAN|2.68|<|0.0001|TWO_SIDED|95.0|-48.06|-37.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-37.41|-48.06|< 0.0001
71052845|NCT03433755|141610325|SUPERIORITY||Treatment difference|-44.3|STANDARD_ERROR_OF_MEAN|2.38|<|0.0001|TWO_SIDED|95.0|-49.02|-39.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-39.58|-49.02|< 0.0001
71052846|NCT03433755|141610326|SUPERIORITY||Treatment difference|-43.05|STANDARD_ERROR_OF_MEAN|3.05|<|0.0001|TWO_SIDED|95.0|-49.09|-37.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-37.00|-49.09|< 0.0001
71052847|NCT03433755|141610326|SUPERIORITY||Treatment difference|-40.42|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-45.98|-34.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-34.87|-45.98|< 0.0001
71052848|NCT03433755|141610327|SUPERIORITY||Treatment difference|87.2|||<|0.0001|TWO_SIDED|95.0|72.6|92.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||92.8|72.6|< 0.0001
70932380|NCT02307682|141364358|OTHER||Difference in proportions|-3.2|||||TWO_SIDED|95.0|-8.4|1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||1.7|-8.4|
70932381|NCT02307682|141364358|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-6.2|5.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||5.2|-6.2|
70932382|NCT02307682|141364358|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-7.5|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||3.4|-7.5|
71052849|NCT03433755|141610327|SUPERIORITY||Treatment difference|91.5|||<|0.0001|TWO_SIDED|95.0|76.9|96.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab QM - Placebo QM|||96.1|76.9|< 0.0001
71052850|NCT03433755|141610328|SUPERIORITY||Treatment difference|90.6|||<|0.0001|TWO_SIDED|95.0|76.6|95.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||95.6|76.6|< 0.0001
71052851|NCT03433755|141610328|SUPERIORITY||Treatment difference|85.7|||<|0.0001|TWO_SIDED|95.0|68.2|91.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab QM - Placebo QM|||91.9|68.2|< 0.0001
71052852|NCT03433755|141610329|SUPERIORITY||Treatment difference|87.0|||<|0.0001|TWO_SIDED|95.0|73.3|93.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||93.0|73.3|< 0.0001
71052853|NCT03433755|141610329|SUPERIORITY||Treatment difference|88.7|||<|0.0001|TWO_SIDED|95.0|73.5|94.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab QM - Placebo QM|||94.0|73.5|< 0.0001
71052854|NCT03433755|141610330|SUPERIORITY||Treatment difference|82.8|||<|0.0001|TWO_SIDED|95.0|67.8|90.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||90.1|67.8|< 0.0001
71117613|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
71052855|NCT03433755|141610330|SUPERIORITY||Treatment difference|82.7|||<|0.0001|TWO_SIDED|95.0|64.8|89.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab QM - Placebo QM|||89.7|64.8|< 0.0001
71052856|NCT03433755|141610331|SUPERIORITY||Treatment difference|-48.45|STANDARD_ERROR_OF_MEAN|4.71|<|0.0001|TWO_SIDED|95.0|-57.78|-39.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-39.11|-57.78|< 0.0001
71052857|NCT03433755|141610331|SUPERIORITY||Treatment difference|-40.43|STANDARD_ERROR_OF_MEAN|4.13|<|0.0001|TWO_SIDED|95.0|-48.62|-32.24||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-32.24|-48.62|< 0.0001
71052858|NCT03433755|141610332|SUPERIORITY||Treatment difference|-44.7|STANDARD_ERROR_OF_MEAN|5.07|<|0.0001|TWO_SIDED|95.0|-54.76|-34.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-34.65|-54.76|< 0.0001
71052859|NCT03433755|141610332|SUPERIORITY||Treatment difference|-38.26|STANDARD_ERROR_OF_MEAN|5.88|<|0.0001|TWO_SIDED|95.0|-49.94|-26.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-26.59|-49.94|< 0.0001
71052860|NCT03433755|141610333|SUPERIORITY||Treatment difference|-15.09|STANDARD_ERROR_OF_MEAN|4.71||0.008|TWO_SIDED|95.0|-24.44|-5.75||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-5.75|-24.44|0.008
71052861|NCT03433755|141610333|SUPERIORITY||Treatment difference|-19.67|STANDARD_ERROR_OF_MEAN|4.35|<|0.0001|TWO_SIDED|95.0|-28.3|-11.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-11.05|-28.30|< 0.0001
70932383|NCT02307682|141364358|OTHER||Difference in proportions|-4.5|||||TWO_SIDED|95.0|-9.5|0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||0.7|-9.5|
71052862|NCT03433755|141610334|SUPERIORITY||Treatment difference|-17.56|STANDARD_ERROR_OF_MEAN|5.98||0.008|TWO_SIDED|95.0|-29.42|-5.69||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-5.69|-29.42|0.008
71052863|NCT03433755|141610334|SUPERIORITY||Treatment difference|-12.35|STANDARD_ERROR_OF_MEAN|5.38|<|0.0001|TWO_SIDED|95.0|-23.04|-1.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-1.67|-23.04|< 0.0001
71052864|NCT03433755|141610335|SUPERIORITY||Treatment difference|8.44|STANDARD_ERROR_OF_MEAN|2.56||0.008|TWO_SIDED|95.0|3.35|13.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||13.52|3.35|0.008
71052865|NCT03433755|141610335|SUPERIORITY||Treatment difference|6.8|STANDARD_ERROR_OF_MEAN|2.37||0.017|TWO_SIDED|95.0|2.1|11.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||11.50|2.10|0.017
71052866|NCT03433755|141610336|SUPERIORITY||Treatment difference|7.94|STANDARD_ERROR_OF_MEAN|2.91||0.008|TWO_SIDED|95.0|2.18|13.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||13.71|2.18|0.008
71052867|NCT03433755|141610336|SUPERIORITY||Treatment difference|6.17|STANDARD_ERROR_OF_MEAN|0.036||0.017|TWO_SIDED|95.0|0.42|11.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||11.92|0.42|0.017
71052868|NCT03433755|141610337|SUPERIORITY||Treatment difference|-22.96|STANDARD_ERROR_OF_MEAN|4.44||0.0002|TWO_SIDED|95.0|-33.12|-12.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-12.81|-33.12|0.0002
71052869|NCT03433755|141610337|SUPERIORITY||Treatment difference|-27.81|STANDARD_ERROR_OF_MEAN|4.44|<|0.0001|TWO_SIDED|95.0|-36.6|-19.02||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-19.02|-36.60|< 0.0001
71052870|NCT03433755|141610338|SUPERIORITY||Treatment difference|-21.78|STANDARD_ERROR_OF_MEAN|6.32||0.0002|TWO_SIDED|95.0|-34.31|-9.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-9.25|-34.31|0.0002
71106225|NCT01959932|141719315|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|23.45|||<|0.001|TWO_SIDED|95.0|22.0|24.99||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on COHb levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||24.99|22.00|<0.001
71106226|NCT00758563|141719316|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.05
71106227|NCT00060944|141719317|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.734||||0.0302|TWO_SIDED|95.0|0.554|0.974|||Log Rank|||||0.974|0.554|0.0302
71052871|NCT03433755|141610338|SUPERIORITY||Treatment difference|-15.74|STANDARD_ERROR_OF_MEAN|5.33|<|0.0001|TWO_SIDED|95.0|-26.31|-5.18||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-5.18|-26.31|< 0.0001
71052872|NCT00006721|141610355|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79||||0.11|TWO_SIDED|95.0|0.6|1.05|||Regression, Cox|adjusting for the stratification factor (serum beta-2 microglobulin level)|CHOP + Tositumomab versus CHOP + Rituximab|||1.05|0.6|0.11
71052873|NCT00006721|141610359|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.55||||0.08|TWO_SIDED|95.0|0.95|2.54|||Regression, Cox|adjusting for the stratification factor (serum beta-2 microglobulin level)|CHOP + Tositumomab versus CHOP + Rituximab|||2.54|0.95|0.08
71052874|NCT02081209|141610363|OTHER||sucess percentage|82.4|||||TWO_SIDED|95.0|76.4|87.3||||||||87.3|76.4|
71052875|NCT02081209|141610363|OTHER||sucess percentage|77.4|||||TWO_SIDED|95.0|68.1|85.1||||||||85.1|68.1|
71052876|NCT02081209|141610363|OTHER||sucess percentage|79.2|||||TWO_SIDED|95.0|65.0|89.5||||||||89.5|65.0|
70851298|NCT00669409|141190540|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-17.8|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-34.4|-1.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-1.2|-34.4|
71020244|NCT00996918|141547370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.938|TWO_SIDED|95.0|-1.12|1.21|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 6.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.21|-1.12|0.938
71020245|NCT00996918|141547370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.753|TWO_SIDED|95.0|-1.43|1.04|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 6.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.04|-1.43|0.753
71020246|NCT00996918|141547370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.809|TWO_SIDED|95.0|-1.04|1.33|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 19.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.33|-1.04|0.809
71020247|NCT00996918|141547370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.421|TWO_SIDED|95.0|-1.8|0.75|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 19.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||0.75|-1.80|0.421
71020248|NCT00996918|141547370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.535|TWO_SIDED|95.0|-0.85|1.63|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 32.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.63|-0.85|0.535
71020249|NCT00996918|141547370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.445|TWO_SIDED|95.0|-0.82|1.86|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 32.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.86|-0.82|0.445
71020250|NCT00996918|141547370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73||||0.309|TWO_SIDED|95.0|-0.67|2.12|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 45.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.12|-0.67|0.309
71020251|NCT00996918|141547370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.872|TWO_SIDED|95.0|-1.34|1.57|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 45.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.57|-1.34|0.872
71020252|NCT00996918|141547370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.52||||0.004|TWO_SIDED|95.0|0.79|4.26|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.26|0.79|0.004
71020253|NCT00996918|141547370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.09||||0.026|TWO_SIDED|95.0|0.25|3.93|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.93|0.25|0.026
71020254|NCT00996918|141547371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.504|TWO_SIDED|95.0|-0.77|1.57|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 6.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.57|-0.77|0.504
71052877|NCT02081209|141610363|OTHER||sucess percentage|94.0|||||TWO_SIDED|95.0|84.6|98.8||||||||98.8|84.6|
71052878|NCT02081209|141610364|OTHER||Mean Difference (Net)|2.3|STANDARD_DEVIATION|1.9|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71052879|NCT02081209|141610364|OTHER||Mean Difference (Net)|1.3|||||TWO_SIDED|95.0|0.5|2.1||||||||2.1|0.5|
71052880|NCT02081209|141610364|OTHER||Mean Difference (Net)|3.0|||||TWO_SIDED|95.0|2.0|4.1||||||||4.1|2.0|
71052881|NCT02081209|141610365|OTHER||||||||||||||||||Data from the 16-week follow-up questionnaire were tabulated for all subjects with completed questionnaires.. All confidence intervals were calculated at 95%. Alpha was calculated to be 0.05, critical probability (p\*) was calculated to be 0.975. Assuming normal distribution of survey recipients, a standard deviation of 1.96 is used to calculate the standard margin of error.|||
70851299|NCT00669409|141190540|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-20.0|13.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.2|-20.0|
71106228|NCT00060944|141719320|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.755||||0.0418|TWO_SIDED|95.0|0.574|0.992|||Log Rank|||||0.992|0.574|0.0418
71106229|NCT00060944|141719321|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.843||||0.192|TWO_SIDED|95.0|0.653|1.09|||Log Rank|||||1.090|0.653|0.1920
71106230|NCT01138514|141719322|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|provides 85% power of success|equivalence ratio|98.77||||0.05|TWO_SIDED|90.0|95.2|102.5|||Fieller's method|||||102.5|95.2|0.05
71106231|NCT01138514|141719323|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|provides 85% power of success|equivalence ratio|100.27||||0.05|TWO_SIDED|90.0|95.6|105.2|||Fieller's method|||||105.2|95.6|0.05
71052882|NCT05205772|141610366|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
71052883|NCT05205772|141610366|OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
71052884|NCT05205772|141610366|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
71052885|NCT05205772|141610366|SUPERIORITY|||||||0.98|||||||ANOVA|||||||0.98
71052886|NCT05205772|141610366|SUPERIORITY|||||||0.41|||||||ANOVA|||||||0.41
71052887|NCT05205772|141610366|SUPERIORITY|||||||0.63|||||||ANOVA|||||||0.63
71052888|NCT05205772|141610367|OTHER|||||||0.38||||||Adjusted for age.|Regression, Linear|||||||0.38
71106232|NCT01138514|141719324|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"Clinical success was defined as a score of clear (0) or almost clear (1) on Investigators Global Assessment (IGA) at Visit 4/Week 10"|equivalence difference|1.6||||0.05|TWO_SIDED|90.0|-4.2|7.4|||Wald's method Yates' continuity correct|||||7.4|-4.2|0.05
71052889|NCT05205772|141610368|OTHER|||||||0.67||||||Adjusted for age.|Regression, Linear|||||||0.67
71052890|NCT05205772|141610369|OTHER|||||||0.156|||||||Regression, Linear|||||||0.156
71052891|NCT06378749|141610374|OTHER|||||||0.029|||||||t-test, 2 sided|||||||.029
71052892|NCT06378749|141610375|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71052893|NCT06378749|141610376|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71052894|NCT06378749|141610377|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71052895|NCT06378749|141610378|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71052896|NCT05538065|141610379|SUPERIORITY||Risk Ratio (RR)|1.4||||0.002|TWO_SIDED|95.0|1.1|1.78||Adjusted for multiple comparisons|Regression, Logistic|||Outcomes were evaluated using generalized estimating equations with a log link and binary errors, adjusting for provider-level clustering and Holm-Bonferroni multiple comparisons.||1.78|1.10|0.002
71052897|NCT05538065|141610379|SUPERIORITY||Risk Ratio (RR)|1.26||||0.039|TWO_SIDED|95.0|1.01|1.57||Adjusted for multiple comparisons|Regression, Logistic|||Outcomes were evaluated using generalized estimating equations with a log link and binary errors, adjusting for provider-level clustering and Holm-Bonferroni multiple comparisons.||1.57|1.01|0.039
71052898|NCT05538065|141610380|SUPERIORITY||Mean Difference (Final Values)|29.0||||0.386|TWO_SIDED|95.0|-36.6|94.6||Adjusted for multiple testing|Regression, Linear|||Outcomes were evaluated using generalized estimating equations with an identity link and normally-distributed errors, adjusting for provider-level clustering and Holm-Bonferroni multiple comparisons.||94.6|-36.6|0.386
71052899|NCT05538065|141610380|SUPERIORITY||Mean Difference (Final Values)|38.1||||272|TWO_SIDED|95.0|-29.9|106.1||Adjusted for multiple comparisons|Regression, Linear|||Outcomes were evaluated using generalized estimating equations with an identity link and normally-distributed errors, adjusting for provider-level clustering and Holm-Bonferroni multiple comparisons.||106.1|-29.9|272
71052900|NCT05538065|141610381|SUPERIORITY||Mean Difference (Final Values)|-13.8||||0.657|TWO_SIDED|95.0|-74.5|47.0||Adjusted for multiple testing|Regression, Linear|||Outcomes were evaluated using generalized estimating equations with an identity link and normally-distributed errors, adjusting for provider-level clustering and Holm-Bonferroni multiple comparisons.||47.0|-74.5|0.657
71106233|NCT03110562|141719369|SUPERIORITY||Hazard Ratio (HR)|0.702||||0.0075|TWO_SIDED|95.0|0.5279|0.9335||One Sided P-value|Stratified Log-rank Test|Stratified for prior PI therapies, number of prior of anti-MM regimens and R-ISS Stage at screening.|Based on stratified Cox Proportional Hazard model with Efron's Method of handling ties.|||0.9335|0.5279|0.0075
71106234|NCT03110562|141719370|SUPERIORITY||Odds Ratio (OR)|1.9626||||0.0012|TWO_SIDED|95.0|1.2641|3.0471||One Sided P-value|Cochran-Mantel-Haenszel|Analysis using Cochran-Mantel-Haenszel test stratified by region, prior PI therapies, number of prior anti-MM regimens, and R-ISS stage at screening.||||3.0471|1.2641|0.0012
71106235|NCT03110562|141719371|SUPERIORITY||Odds Ratio (OR)|1.6594||||0.0082|TWO_SIDED|95.0|1.0993|2.5049||One Sided P-value|Cochran-Mantel-Haenszel|Analysis using Cochran-Mantel-Haenszel test stratified by region, prior PI therapies, number of prior anti-MM regimens, and R-ISS stage at screening.||||2.5049|1.0993|0.0082
71106236|NCT03110562|141719372|SUPERIORITY||Odds Ratio (OR)|0.5042||||0.0013|TWO_SIDED|95.0|0.3216|0.7906||One Sided P-value|Cochran-Mantel-Haenszel||Stratified by Prior PI therapies (Yes or No), Number of prior anti-MM regimens (1 or \>1), and R-ISS stage at study entry (R-ISS Stage III versus R-ISS Stage I or II).|||0.7906|0.3216|0.0013
71106237|NCT03110562|141719373|SUPERIORITY||Hazard Ratio (HR)|0.8764||||0.2152|TWO_SIDED|95.0|0.6313|1.2168||One Sided P-value|Stratified log-rank test|Stratified for prior PI therapies, number of prior anti-MM regimens and R-ISS Stage at screening.|Based on stratified Cox Proportional Hazard model with Efron's Method of handling ties.|||1.2168|0.6313|0.2152
70851300|NCT00669409|141190540|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.5|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-29.9|2.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.9|-29.9|
71052901|NCT05538065|141610381|SUPERIORITY||Mean Difference (Final Values)|15.1||||0.696|TWO_SIDED|95.0|-60.7|91.0|||Regression, Linear|Adjusted for multiple testing||Outcomes were evaluated using generalized estimating equations with an identity link and normally-distributed errors, adjusting for provider-level clustering and Holm-Bonferroni multiple comparisons.||91.0|-60.7|0.696
70851301|NCT00669409|141190540|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-28.5|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-50.3|-6.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-6.7|-50.3|
70851302|NCT00669409|141190541|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|12.4|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-4.3|29.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||29.1|-4.3|
71052902|NCT00191113|141610382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|||<|0.001||95.0|0.7|1.1|||ANCOVA|Model includes baseline height SDS, baseline age, treatment, and interactions. Age and interaction terms removed when not significant.|"Effect direction is As-Randomized Humatrope minus As-Randomized Control"|This component of the primary analysis is inferential i.e. to ascertain definitively whether Humatrope treatment affects change in Height SDS (NCHS). Null hypothesis is no effect of Humatrope treatment.||1.1|0.7|<0.001
71052903|NCT00191113|141610383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|||<|0.001||95.0|0.9|1.2|||ANCOVA|Model includes baseline height SDS, baseline age, treatment, and interactions. Age and interactions terms removed when not significant.|"Effect direction is As-Treated Growth Hormone minus As-Treated No Growth Hormone"|Estimation analysis of the magnitude of effect of treatment with growth hormone upon Final Height. Null hypothesis is no effect of growth hormone upon attained height standard deviation score (National Center for Health Statistics).||1.2|0.9|<0.001
71052904|NCT00191113|141610384|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|||<|0.001||95.0|0.9|1.3|||ANCOVA|||||1.3|0.9|<0.001
71052905|NCT00191113|141610385|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.9|||<|0.001||95.0|5.7|8.1|||ANCOVA|||||8.1|5.7|<0.001
71052906|NCT00191113|141610386|SUPERIORITY_OR_OTHER||||||>|0.999||95.0|||||Fisher Exact|||||||>0.999
71052907|NCT00191113|141610387|SUPERIORITY_OR_OTHER|||||||0.744||95.0|||||Fisher Exact|||||||0.744
71052908|NCT00191113|141610388|SUPERIORITY_OR_OTHER|||||||0.073||95.0|||||Fisher Exact|||||||0.073
71052909|NCT00191113|141610389|SUPERIORITY_OR_OTHER||||||>|0.999||95.0|||||Fisher Exact|||Comparison of proportion of patients with any category of hearing loss between As-Treated Growth Hormone group and As-Treated No Growth Hormone.||||>0.999
71052910|NCT00191113|141610390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.492||||0.419||95.0|-8.631|3.646|||ANOVA||Direction of estimated treatment effect is Humatrope minus Control|||3.646|-8.631|0.419
71052911|NCT00191113|141610392|SUPERIORITY_OR_OTHER|||||||0.545||95.0|||||Fisher Exact|||||||0.545
71052912|NCT00191113|141610394|SUPERIORITY_OR_OTHER||||||>|0.999||95.0|||||Fisher Exact|||||||>0.999
71052913|NCT00191113|141610396|SUPERIORITY_OR_OTHER||||||>|0.999||95.0|||||Fisher Exact|||||||>0.999
71052914|NCT00191113|141610397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007||||0.945||95.0|-0.199|0.186|||ANOVA||Direction of estimated treatment effect is Humatrope minus Control|||0.186|-0.199|0.945
71052915|NCT00191113|141610399|SUPERIORITY_OR_OTHER|||||||||95.0||||P-value cannot be computed since no patients had abnormal result in either comparison group.|Fisher Exact|||||||
70851303|NCT00669409|141190541|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.8|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-31.4|1.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.9|-31.4|
71052916|NCT03786718|141610438|OTHER||||||<|0.001|||||||One sample median test|||Due to nonnormality, we used nonparametric tests to analyze the data. This analysis is a one sample median test of participants' median SUS score compared to the threshold score of 68 indicative of 'above average' usability.||||<0.001
71052917|NCT03786718|141610442|OTHER|||||||0.77|||||||Wilcoxon Signed Rank Sum test|||||||0.77
71052918|NCT03786718|141610443|OTHER|||||||0.02|||||||Wilcoxon Signed Rank Sum test|||Analysis for pre-post change in General Diet sub-scale score||||0.02
71052919|NCT03786718|141610443|OTHER|||||||0.13|||||||Wilcoxon Signed Rank Sum test|||Analysis for pre-post change in Specific Diet sub-scale score||||0.13
71052920|NCT03786718|141610443|OTHER|||||||0.35|||||||Wilcoxon Signed Rank Sum test|||Analysis for pre-post change in Exercise sub-scale score||||0.35
71052921|NCT03786718|141610443|OTHER|||||||0.67|||||||Wilcoxon Signed Rank Sum test|||Analysis for pre-post change in Blood-glucose Testing sub-scale score||||0.67
71052922|NCT03786718|141610443|OTHER|||||||0.65|||||||Wilcoxon Signed Rank Sum test|||Analysis for pre-post change in Foot Care sub-scale score||||0.65
71052923|NCT03786718|141610444|OTHER|||||||0.001|||||||Wilcoxon Signed Rank Sum test|||||||0.001
71052924|NCT03786718|141610445|OTHER|||||||0.86|||||||Wilcoxon Signed Rank Sum test|||||||0.86
71052925|NCT03786718|141610446|OTHER|||||||0.3|||||||McNemar|||Analysis for pre-post change in knowledge of definition of A1C||||0.30
71052926|NCT03786718|141610446|OTHER|||||||1|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for hemoglobin A1c.||||1.00
71052927|NCT03786718|141610446|OTHER|||||||0.63|||||||McNemar|||Analysis for pre-post change in knowledge of definition of systolic blood pressure||||0.63
71052928|NCT03786718|141610446|OTHER|||||||0.02|||||||McNemar|||Analysis of pre-post change in knowledge of goal range for systolic blood pressure||||0.02
71052929|NCT03786718|141610446|OTHER|||||||0.55|||||||McNemar|||Analysis of pre-post change in knowledge of definition of LDL cholesterol||||0.55
71052930|NCT03786718|141610446|OTHER|||||||0.0009|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for LDL cholesterol||||0.0009
71052931|NCT03786718|141610446|OTHER|||||||1|||||||McNemar|||Analysis of pre-post change in knowledge of definition of flu vaccine||||1.00
71052932|NCT03786718|141610446|OTHER|||||||1|||||||McNemar|||Analysis of pre-post change in knowledge of recommended frequency of flu vaccination||||1.00
71052933|NCT03786718|141610447|OTHER|||||||0.15|||||||Wilcoxon Signed Rank Sum test|||||||0.15
71052934|NCT03786718|141610448|OTHER|||||||0.23|||||||McNemar|||Analysis of pre-post change in interest in information about how my diabetes health data compares to other patients like me (i.e., social comparison information)||||0.23
71052935|NCT03786718|141610448|OTHER|||||||1|||||||McNemar|||Analysis of pre-post change in interest in information about how their diabetes health data compares to the goal range (i.e., goal-based comparison information)||||1.00
71052936|NCT03786718|141610448|OTHER|||||||0.51|||||||McNemar|||Analysis of pre-post change in agreement with statement: 'Information about how my diabetes health data compares to other patients like me \[social comparison information\] is useful.'||||0.51
70932384|NCT02307682|141364358|OTHER||Difference in proportions|-5.4|||||TWO_SIDED|95.0|-10.6|-0.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-0.6|-10.6|
71020255|NCT00996918|141547371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.592|TWO_SIDED|95.0|-1.58|0.9|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 6.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||0.90|-1.58|0.592
70932385|NCT02307682|141364358|OTHER||Difference in proportions|-4.6|||||TWO_SIDED|95.0|-10.2|1.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||1.3|-10.2|
71020256|NCT00996918|141547371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.441|TWO_SIDED|95.0|-0.72|1.65|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 19.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.65|-0.72|0.441
71020257|NCT00996918|141547371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.288|TWO_SIDED|95.0|-1.97|0.59|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 19.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||0.59|-1.97|0.288
71020258|NCT00996918|141547371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.303|TWO_SIDED|95.0|-0.59|1.9|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 32.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.90|-0.59|0.303
71020259|NCT00996918|141547371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.713|TWO_SIDED|95.0|-1.09|1.6|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 32.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.60|-1.09|0.713
71020260|NCT00996918|141547371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93||||0.198|TWO_SIDED|95.0|-0.49|2.34|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 45.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.34|-0.49|0.198
71020261|NCT00996918|141547371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.756|TWO_SIDED|95.0|-1.7|1.24|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 45.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.24|-1.70|0.756
71020262|NCT00996918|141547371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.45||||0.006|TWO_SIDED|95.0|0.69|4.22|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.22|0.69|0.006
71020263|NCT00996918|141547371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.75||||0.066|TWO_SIDED|95.0|-0.12|3.62|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.62|-0.12|0.066
71020264|NCT00854607|141547387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.166|TWO_SIDED|90.0|-0.2|0.77||One-Sided P-value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.77|-0.20|0.166
71020265|NCT00854607|141547388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.269|TWO_SIDED|90.0|-0.65|0.3||One-Sided P-value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.30|-0.65|0.269
71020266|NCT00854607|141547389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.101|TWO_SIDED|90.0|-0.06|0.44||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.44|-0.06|0.101
71020267|NCT00854607|141547390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.457|TWO_SIDED|90.0|-0.42|0.47||One-Sided P-Value|t-test, 1 sided|||Mean Difference Between Non-Responders and Responders||0.47|-0.42|0.457
71020268|NCT00854607|141547391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.168|TWO_SIDED|90.0|-0.87|0.23||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.23|-0.87|0.168
71020269|NCT00854607|141547392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.127|TWO_SIDED|90.0|-0.09|0.46||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.46|-0.09|0.127
71020270|NCT00854607|141547393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.054|TWO_SIDED|90.0|-0.01|0.96||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.96|-0.01|0.054
71106238|NCT05788991|141719397|NON_INFERIORITY|Difference of proportions between groups (with 95% CI) and a non inferiority margin of 15 percentage points, assuming a 1-sided α = .025 and 80% power|Farrington-Manning test|-0.5|||<|0.025|ONE_SIDED|95.0|-10.8|||1 sided alpha|Farrington-Manning test|||The outcome measure of the primary objective was a noninferiority margin of 15 percentage points in the absolute difference in clinical cure rates between dequalinium chloride and metronidazole 7 to 11 days after start of treatment.|||-10.8|<.025
71106239|NCT05270863|141719404|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<.001
71106240|NCT04464473|141719405|SUPERIORITY|||||||0.5736|||||||ANOVA|The main effect of visit (Baseline, FPl-TMS, MFG-TMS, S1-TMS) on the overall magnitude of MFG efferent connectivity||||||0.5736
71020271|NCT00854607|141547394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.285|TWO_SIDED|90.0|-0.41|0.83||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.83|-0.41|0.285
71020272|NCT00854607|141547395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.159|TWO_SIDED|90.0|-0.27|1.08||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||1.08|-0.27|0.159
71052937|NCT03786718|141610448|OTHER|||||||0.63|||||||McNemar|||Analysis of pre-post change in agreement with statement: 'Information about how my diabetes health data compares to the goals range \[goal-based comparison information\] is useful.||||0.63
71052938|NCT03786718|141610449|OTHER|||||||0.01|||||||Wilcoxon Signed Rank Sum test|||||||0.01
71052939|NCT00368979|141610450|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.003||95.0|-2.7|-0.5|||ANCOVA|||||-0.5|-2.7|0.003
71052940|NCT00945100|141610458|SUPERIORITY_OR_OTHER||Risk difference (unadjusted)|22.0||||0.003|TWO_SIDED|95.0|8.0|35.0|||Regression, Logistic|The logistic regression model included amblyopic eye visual acuity at randomization as an adjustment covariate.||||35|8|0.003
71106241|NCT04464473|141719405|SUPERIORITY|||||||0.304|||||||ANOVA|Interaction of visit (Baseline, FPl-TMS, MFG-TMS, S1-TMS) and subsystem (Temporal, Contextual Control) on the magnitude of MFG efferent connectivity||||||0.304
71106242|NCT04464473|141719405|SUPERIORITY|||||||0.0545|||||||ANOVA|The main effect of visit (Baseline, FPl-TMS, MFG-TMS, S1-TMS) on the overall magnitude of FPl efferent connectivity||||||0.0545
71052941|NCT00945100|141610459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5||||0.01|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|The ANCOVA model included interocular difference at randomization as an adjustment covariate.||||1.0|0.1|0.01
71052942|NCT00945100|141610461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.002|TWO_SIDED|95.0|0.3|1.0|||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||The primary analysis was a treatment group comparison of the masked 10-week amblyopic eye visual acuity using an analysis of covariance (ANCOVA) model, adjusting for visual acuity at randomization. The analysis was a 2-sided test for efficacy to test the null hypothesis of no treatment difference, assuming 90% power and a type I error rate of 5%.||1.0|0.3|0.002
71052943|NCT00945100|141610465|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||The treatment effect within gender was assessed by including an interaction term between treatment group and gender in the ANCOVA model, adjusting for amblyopic eye visual acuity at randomization and main effects corresponding to the interaction term.||||0.04
71052944|NCT00945100|141610465|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||The treatment effect within race/ethnicity was assessed by including an interaction term between treatment group and race/ethnicity in the ANCOVA model, adjusting for amblyopic eye visual acuity at randomization and main effects corresponding to the interaction term.||||0.89
71052945|NCT00945100|141610465|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||The treatment effect within age at randomization was assessed by including an interaction term between treatment group and age in the ANCOVA model, adjusting for amblyopic eye visual acuity at randomization and main effects corresponding to the interaction term.||||0.49
71052946|NCT00945100|141610465|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||ANCOVA|||The treatment effect within amblyopic eye visual acuity at randomization was assessed by including an interaction term between treatment group and visual acuity in the ANCOVA model, adjusting for the main effects corresponding to the interaction term.||||0.37
71020273|NCT00854607|141547396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.071|TWO_SIDED|90.0|-0.02|0.32||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.32|-0.02|0.071
71020274|NCT00854607|141547397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.078|TWO_SIDED|90.0|-0.03|0.38||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.38|-0.03|0.078
71106243|NCT04464473|141719405|SUPERIORITY|||||||0.1134|||||||ANOVA|Interaction of visit (Baseline, FPl-TMS, MFG-TMS, S1-TMS) and Subsystem on the magnitude of FPl efferent connectivity||||||0.1134
71106244|NCT04464473|141719405|SUPERIORITY|||||||0.4326|||||||ANOVA|The main effect of intervention (FPl-TMS, MFG-TMS, S1-TMS) on the overall magnitude of MFG efferent connectivity||||||0.4326
71106245|NCT04464473|141719405|SUPERIORITY|||||||0.2546|||||||ANOVA|The interaction of intervention (FPl-TMS, MFG-TMS, S1-TMS) and subsystem (Temporal, Contextual Control) on the magnitude of MFG efferent connectivity||||||0.2546
71106246|NCT04464473|141719405|SUPERIORITY|||||||0.0645|||||||ANOVA|The main effect of intervention (FPl-TMS, MFG-TMS, S1-TMS) on the overall magnitude of FPl efferent connectivity||||||0.0645
71106247|NCT04464473|141719405|SUPERIORITY|||||||0.2033|||||||ANOVA|Interaction of intervention (FPl-TMS, MFG-TMS, S1-TMS) and Subsystem on the magnitude of FPl efferent connectivity||||||0.2033
71106248|NCT04464473|141719406|SUPERIORITY|||||||0.8152|||||||ANOVA|Main effect of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) on overall BOLD actviation.||||||0.8152
71106249|NCT04464473|141719406|SUPERIORITY|||||||0.0085|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and subsystem (temporal, contextual, sensorimotor control) on overall BOLD activation.||||||0.0085
71106250|NCT04464473|141719406|SUPERIORITY|||||||0.1551|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and temporal control on BOLD activation||||||0.1551
70932386|NCT02307682|141364358|OTHER||Difference in proportions|-6.3|||||TWO_SIDED|95.0|-12.2|-0.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-0.8|-12.2|
70932387|NCT02307682|141364358|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-6.6|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.3|-6.6|
71020275|NCT00854607|141547398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.109|TWO_SIDED|90.0|-0.13|0.91||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.91|-0.13|0.109
71020276|NCT00854607|141547399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65||||0.03|TWO_SIDED|90.0|0.09|1.22||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||1.22|0.09|0.030
71020277|NCT00854607|141547400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.293|TWO_SIDED|90.0|-0.63|0.32||One-Sided P-value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.32|-0.63|0.293
71020278|NCT00854607|141547401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.213|TWO_SIDED|90.0|-0.83|0.29||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.29|-0.83|0.213
71020279|NCT00190684|141547404|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for systolic BP|Wilcoxon signed-rank test|Change = endpoint-baseline||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71020280|NCT00190684|141547404|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for diastolic BP|Wilcoxon sign-rank test|Change = endpoint-baseline||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71020281|NCT00190684|141547405|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for pulse|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71020282|NCT00190684|141547406|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for weight|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71020283|NCT00190684|141547407|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for height|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71020284|NCT00190684|141547408|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for weight 0 to 25th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71020285|NCT00190684|141547408|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for weight 25th to 50th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71020286|NCT00190684|141547408|SUPERIORITY_OR_OTHER|||||||0.644||95.0||||p-value is for weight 50th to 75th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.644
71020287|NCT00190684|141547408|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for weight 75th to 100th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71020288|NCT00190684|141547408|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for height 0 to 25th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71020289|NCT00190684|141547408|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||p-value is for height 25th to 50th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.001
71020290|NCT00190684|141547408|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||p-value is for height 50th to 75th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.044
71020291|NCT00190684|141547408|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for height 75th to 100th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71020292|NCT00190684|141547408|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for BMI 0 to 25th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71020293|NCT00190684|141547408|SUPERIORITY_OR_OTHER|||||||0.032||95.0||||p-value is for BMI 25th to 50th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.032
71020294|NCT00190684|141547408|SUPERIORITY_OR_OTHER|||||||0.351||95.0||||p-value is for BMI 50th to 75th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.351
71020295|NCT00190684|141547408|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for BMI 75th to 100th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71020296|NCT00190684|141547409|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for RR interval|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71020297|NCT00190684|141547409|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for QRS Interval|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71020298|NCT00190684|141547409|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for QT Bazett Correction|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71020299|NCT00190684|141547409|SUPERIORITY_OR_OTHER|||||||0.31||95.0||||p-value is for QT Data Correction|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.310
71052947|NCT00945100|141610465|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||The treatment effect within cause of amblyopia was assessed by including an interaction term between treatment group and amblyopia cause in the ANCOVA model, adjusting for amblyopic eye visual acuity at randomization and main effects corresponding to the interaction term.||||0.50
71106251|NCT04464473|141719406|SUPERIORITY|||||||0.6431|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and contextual control on BOLD activation||||||0.6431
71020300|NCT00190684|141547409|SUPERIORITY_OR_OTHER|||||||0.632||95.0||||p-value is for QT Fridericia Correction|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.632
71020301|NCT00190684|141547410|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for HR.|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71020302|NCT00190684|141547412|SUPERIORITY_OR_OTHER||||||p<|0||95.0||||p-value is for Total Score|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||p<0.001
71020303|NCT00190684|141547412|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Inattentive Subscale Score|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71020304|NCT00190684|141547412|SUPERIORITY_OR_OTHER||||||p<|0||95.0||||p-value is for Hyperactive Subscale Score|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||p<0.001
71020305|NCT00190684|141547413|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for CGI ADHD Severity within group|Wilcoxon signed-rank test|This test is for a significance of a location shift from zero of the change from baseline within a treatment group.||||||<0.001
71020306|NCT00190684|141547414|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for CPRS ADHD Index Subscale within group|Wilcoxon signed-rank test|This test is for a significance of a location shift from zero of the change from baseline within a treatment group.||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71020307|NCT00190684|141547414|SUPERIORITY_OR_OTHER||||||p<|0||95.0||||p-value is for CPRS Cognitive Subscale|Wilcoxon signed-rank test|This test is for a significance of a location shift from zero of the change from baseline within a treatment group.||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||p<0.001
71052948|NCT00945100|141610467|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|0.04|1.0|||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||||1.0|0.04|
71052949|NCT00945100|141610475|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fisher's exact test was used to compare the proportion of participants in each treatment group with a loss of 2 or more lines in the better of the initial test and retest (if indicated) fellow eye visual acuities at the 10-week exam.||||>0.99
71052950|NCT00945100|141610477|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Fisher Exact|||Fisher's exact test was used to compare the proportion of participants in each treatment group with a loss of 2 or more lines in the better of the initial test and retest (if indicated) fellow eye visual acuities at the final exam.||||0.12
71020308|NCT00190684|141547414|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||p-value is for CPRS Hyperactive Subscale|Wilcoxon signed-rank test|This test is for a significance of a location shift from zero of the change from baseline within a treatment group.||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.026
71020309|NCT00190684|141547414|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for CPRS Oppositional Subscale|Wilcoxon signed-rank test|This test is for a significance of a location shift from zero of the change from baseline within a treatment group.||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71020310|NCT00123487|141547427|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the QD schedule relative to the BID schedule was claimed if the lower bound of the 95% CI for difference (QD - BD) was ≥ -12%.|Percent Difference|0.2|||||TWO_SIDED|95.0|-7.8|8.1||||||Primary endpoint was to be assessed at 6-Months: Assuming a 45% MaHR rate in the 70 mg BID participants, the primary efficacy analysis required a total of 540 participants, approximately 270 in each dosing schedule, giving at least 80% power to deduce non-inferiority of the QD schedule relative to the BID schedule if the lower bound of the 95% CI for the difference in MaHR rates (MaHRRQD - MaHRRBID) is greater than -12%.||8.1|-7.8|
71052951|NCT00945100|141610481|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||Wilcoxon (Mann-Whitney)|||An Exact Wilcoxon rank sum test was used for the difference between treatment groups in the distribution of levels of change in Randot Preschool Stereoacuity from randomization to 10 weeks.||||0.28
71106252|NCT04464473|141719406|SUPERIORITY|||||||0.2447|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), temporal control, and contextual control on BOLD activation||||||0.2447
71106253|NCT04464473|141719406|SUPERIORITY|||||||0.0002|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), temporal control, and subsystem (temporal, contextual, sensorimotor) on BOLD activation||||||0.0002
71106254|NCT04464473|141719406|SUPERIORITY|||||||0.1339|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), contextual control, and subsystem on BOLD activation||||||0.1339
70932388|NCT02307682|141364358|OTHER||Difference in proportions|-4.7|||||TWO_SIDED|95.0|-10.0|0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||0.1|-10.0|
70932389|NCT02307682|141364358|OTHER||Difference in proportions|-4.0|||||TWO_SIDED|95.0|-9.4|1.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||1.4|-9.4|
70932390|NCT02307682|141364358|OTHER||Difference in proportions|-8.1|||||TWO_SIDED|95.0|-13.6|-2.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-2.7|-13.6|
70932391|NCT02307682|141364358|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-5.1|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.5|-5.1|
70932392|NCT02307682|141364358|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-6.2|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||2.8|-6.2|
70932393|NCT02307682|141364358|OTHER||Difference in proportions|-4.2|||||TWO_SIDED|95.0|-9.4|1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||1.2|-9.4|
70932394|NCT02307682|141364358|OTHER||Difference in proportions|-6.2|||||TWO_SIDED|95.0|-11.5|-0.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||-0.8|-11.5|
70932395|NCT02307682|141364358|OTHER||Difference in proportions|-2.3|||||TWO_SIDED|95.0|-7.3|3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.0|-7.3|
70932396|NCT02307682|141364358|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-7.9|2.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||2.1|-7.9|
71052952|NCT00945100|141610484|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||Wilcoxon (Mann-Whitney)|||An Exact Wilcoxon rank sum test was used for the difference between treatment groups in the distribution of levels of change in Randot Preschool Stereoacuity from randomization to 10 weeks.||||0.45
71052953|NCT01781481|141610485|SUPERIORITY_OR_OTHER||Inter-rater reliability|0.87|||||TWO_SIDED||||||||Inter rater reliability for a subset of 40 patients whose Pediatric INTERMED was scored by two trained raters. The median inter-rater reliability coefficient was .87.|||||
71052954|NCT01781481|141610485|SUPERIORITY_OR_OTHER||Cronbach's Alpha|0.91|||||TWO_SIDED||||||||Overall internal consistency of the overall Pediatric INTERMED scale (34 items).|||||
71052955|NCT01781481|141610486|SUPERIORITY_OR_OTHER||||||<|0.05||||||Correlation between the biological and psychological domain scores on the Pediatric INTERMED. The threshold for significance is p\< .05.|Pearson Correlation Coefficients|||||||<0.05
71052956|NCT01781481|141610486|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between the Biological and Social domain scores on the Pediatric INTERMED.||||<0.01
71052957|NCT01781481|141610486|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between the Biological and Family/Caregiver Pediatric INTERMED domain scores.||||<0.01
71052958|NCT01781481|141610486|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Biological and Health Service Pediatric INTERMED domain scores.||||<0.01
71106255|NCT04464473|141719406|SUPERIORITY|||||||0.1315|||||||ANOVA|Interaction of visit, temporal control, contextual control, and subsystem on BOLD activation||||||0.1315
71020311|NCT03672396|141547453|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|0.13||||0.378|TWO_SIDED|95.0|-0.2|0.4|||t-test, 2 sided|||||0.4|-0.2|0.378
71020312|NCT03672396|141547454|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|0.35||||0.586|TWO_SIDED|95.0|-1.0|1.7|||t-test, 2 sided|||||1.7|-1.0|0.586
71020313|NCT03672396|141547455|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-0.25||||0.252|TWO_SIDED|95.0|-0.7|0.2|||t-test, 2 sided|||||0.2|-0.7|0.252
71020314|NCT03672396|141547456|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-16.3||||0.111|TWO_SIDED|95.0|-36.9|4.3|||t-test, 2 sided|Mean difference calculated as Post - Pre.||||4.3|-36.9|0.111
71020315|NCT03672396|141547457|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|1.4||||0.579|TWO_SIDED|95.0|-4.3|7.2|||t-test, 2 sided|||||7.2|-4.3|0.579
71106256|NCT04464473|141719406|SUPERIORITY|||||||0.6836|||||||ANOVA|The main effect of intervention arm (FPl-TMS, MFG-TMS, S1-TMS) on overall BOLD activation.||||||0.6836
71020316|NCT03672396|141547458|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-0.1||||0.948|TWO_SIDED|95.0|-3.9|3.7|||t-test, 2 sided|||||3.7|-3.9|0.948
71020317|NCT03672396|141547459|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-0.2||||0.594|TWO_SIDED|95.0|-1.1|0.7|||t-test, 2 sided|||||0.7|-1.1|0.594
71020318|NCT03672396|141547460|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-0.8||||0.274|TWO_SIDED|95.0|-2.3|0.7|||t-test, 2 sided|||||0.7|-2.3|0.274
71020319|NCT03672396|141547461|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|1.89||||0.013|TWO_SIDED|95.0|0.48|3.29|||t-test, 2 sided|||||3.29|0.48|0.013
71020320|NCT03672396|141547462|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|4.16||||0.369|TWO_SIDED|95.0|-5.54|13.85|||t-test, 2 sided|||||13.85|-5.54|0.369
71020321|NCT03672396|141547463|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-0.4||||0.945|TWO_SIDED|95.0|-13.5|12.7|||t-test, 2 sided|||||12.7|-13.5|0.945
71020322|NCT03672396|141547464|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|1.3||||0.42|TWO_SIDED|95.0|-2.0|4.6|||t-test, 2 sided|||||4.6|-2.0|0.420
71020323|NCT03672396|141547465|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-0.6||||0.941|TWO_SIDED|95.0|-16.9|15.8|||t-test, 2 sided|||||15.8|-16.9|0.941
71020324|NCT03672396|141547466|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|2.3||||0.203|TWO_SIDED|95.0|-1.4|5.9|||t-test, 2 sided|||||5.9|-1.4|0.203
71020325|NCT03672396|141547467|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|1.3||||0.057|TWO_SIDED|95.0|-0.04|2.6|||t-test, 2 sided|||||2.6|-0.04|0.057
71052959|NCT01781481|141610486|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Psychology and Social Pediatric INTERMED domain scores.||||<0.01
70851304|NCT00669409|141190541|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-14.6|18.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||18.6|-14.6|
71020326|NCT03672396|141547468|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|0.1||||0.809|TWO_SIDED|95.0|-1.0|1.3|||t-test, 2 sided|||||1.3|-1.0|0.809
71020327|NCT03672396|141547469|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|0.4||||0.191|TWO_SIDED|95.0|-0.3|1.1|||t-test, 2 sided|||||1.1|-0.3|0.191
71020328|NCT03672396|141547470|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|0.5||||0.237|TWO_SIDED|95.0|-0.3|1.3|||t-test, 2 sided|||||1.3|-0.3|0.237
71020329|NCT00500656|141547471|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|3.475|||<|0.001|TWO_SIDED|95.0|1.901|6.355|||The Wilcoxon version of the log rank|The median time to onset was calculated using Kaplan Meier methodology. The Wilcoxon version of the log rank test of SAS was used||||6.355|1.901|< 0.001
70851305|NCT00669409|141190541|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.6|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-25.0|7.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.8|-25.0|
70851306|NCT00669409|141190541|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-23.1|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-44.9|-1.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-1.3|-44.9|
71020330|NCT00500656|141547472|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||The Wilcoxon version of the log rank|The median time to almost complete symptom relief was calculated using Kaplan Meier methodology.The Wilcoxon version of the log rank test SAS was used||||||< 0.001
71020331|NCT00563524|141547508|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5237|||||||ANCOVA|||Baseline: Analysis of covariance (ANCOVA) with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.5237
71020332|NCT00563524|141547508|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8463|||||||ANCOVA|||Day 14: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.8463
71020333|NCT00563524|141547508|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4596|||||||ANCOVA|||Day 28: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.4596
71020334|NCT00563524|141547508|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6345|||||||ANCOVA|||Day 42: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.6345
71020335|NCT00563524|141547508|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6235|||||||ANCOVA|||Day 56: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.6235
71020336|NCT00563524|141547509|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3833|||||||ANCOVA|||Baseline: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.3833
71020337|NCT00563524|141547509|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4909|||||||ANCOVA|||Day 14: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.4909
71052960|NCT01781481|141610486|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||||||<0.01
71052961|NCT01781481|141610486|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological and Health Service Pediatric INTERMED domain scores.||||<0.01
71052962|NCT01781481|141610486|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Social and Family/Caregiver Pediatric INTERMED domain scores.||||<0.01
71052963|NCT01781481|141610486|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Social and Health Service Pediatric INTERMED domain scores.||||<0.01
71020338|NCT00563524|141547509|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22|||||||ANCOVA|||Day 28: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.2200
71020339|NCT00563524|141547509|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4183|||||||ANCOVA|||Day 42: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.4183
71020340|NCT00563524|141547509|SUPERIORITY_OR_OTHER_LEGACY|||||||0.465|||||||ANCOVA|||Day 56: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.4650
71020341|NCT00563524|141547510|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7051|||||||ANCOVA|||Baseline: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.7051
71020342|NCT00563524|141547510|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1072|||||||ANCOVA|||Day 14: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.1072
71020343|NCT00563524|141547510|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||ANCOVA|||Day 28: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.0020
71020344|NCT00563524|141547510|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0079|||||||ANCOVA|||Day 42: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.0079
71020345|NCT00563524|141547510|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0308|||||||ANCOVA|||Day 56: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.0308
71020346|NCT03231709|141547570|OTHER|||||||0.0141|||||||Mainland-Gart Test|||||||0.0141
71020347|NCT01875991|141547575|SUPERIORITY_OR_OTHER|||||||0.501|||||||Van Elteren test|P-value for 'All subjects' from Van Elteren test adjusting for strata (RA or PsO)||||||0.501
71020348|NCT04991311|141547620|SUPERIORITY||Mean Difference (Final Values)|398.4|STANDARD_DEVIATION|581.6|=|0.0585|TWO_SIDED|95.0|-17.6|814.4|||Paired t-test (2-sided, alpha=0.05)|||The participants in both comparison groups are the same.||814.4|-17.6|= 0.0585
71020349|NCT00755937|141547647|SUPERIORITY_OR_OTHER||Percentage (no inferential test)|66.3||||||||||There were no comparisons between groups as this was a single-arm observational study.||||||||
71020350|NCT00755937|141547648|SUPERIORITY_OR_OTHER||percentage (no inferential test)|72.5||||||||||There were no comparisons between groups as this was a single-arm observational study.||||||||
71020351|NCT00755937|141547649|SUPERIORITY_OR_OTHER||Percentage (no inferential test)|72.1||||||||||There were no comparisons between groups as this was a single-arm observational study.||||||||
71020352|NCT00755937|141547650|SUPERIORITY_OR_OTHER||Percentage (no inferential test)|60.3||||||||||There were no comparisons between groups as this was a single-arm observational study.||||||||
71020353|NCT00755937|141547651|SUPERIORITY_OR_OTHER||Percentage (no inferential test)|64.8||||||||||There were no comparisons between groups as this was a single-arm observational study.||||||||
71020354|NCT00755937|141547652|SUPERIORITY_OR_OTHER||Percentage (no inferential test)|72.1||||||||||There were no comparisons between groups as this was a single-arm observational study.||||||||
71020355|NCT01676311|141547654|SUPERIORITY|||||||0.38||||||For each permutation of the data, relevant result was saved and the corresponding p-value represents the proportion of results at least as extreme as observed in the original data.|Regression, Linear|||Regression analysis was run incorporating group, CVLT-II-total learning score at baseline and week 12, and covariates (Beck Depression Index \[BDI\], time post-injury, British Columbia Postconcussion Symptom Inventory \[BC-PSI\]). Regression analyses were repeated, permuting data observations for each outcome. The BDI and BC-PSI are covariates in the regression model and not pre-specified Primary and Secondary Outcome Measures.||||0.38
70932397|NCT02307682|141364358|OTHER||Difference in proportions|-5.2|||||TWO_SIDED|95.0|-10.5|0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||0.7|-10.5|
71020356|NCT01676311|141547654|SUPERIORITY|||||||0.38||||||For each permutation of the data, relevant result was saved and the corresponding p-value represents the proportion of results at least as extreme as observed in the original data.|Regression, Linear|||Regression analysis was run incorporating group (Huperzine A, placebo), baseline CVLT-II-short delay free recall (SDFR) score, outcome (CVLT-II-SDFR at week 12) and covariates (Beck Depression Index, time post-injury, British Columbia Postconcussion Symptom Inventory). Regression analyses were repeated, permuting data observations for each outcome i.e. we permuted the labels (Huperzine A or placebo) among the data observations and re-ran the regression.||||0.38
71020357|NCT01676311|141547654|SUPERIORITY|||||||0.42||||||For each permutation of the data, relevant result was saved and the corresponding p-value represents the proportion of results at least as extreme as observed in the original data.|Regression, Linear|||Regression analysis was run incorporating group (Huperzine A, placebo), baseline CVLT-II-long delay free recall (LDFR) score, outcome (CVLT-II-LDFR at week 12) and covariates (Beck Depression Index, time post-injury, British Columbia Postconcussion Symptom Inventory). Regression analyses were repeated, permuting data observations for each outcome i.e. we permuted the labels (Huperzine A or placebo) among the data observations and re-ran the regression.||||0.42
71020358|NCT01676311|141547657|SUPERIORITY|||||||0.48||||||A chi-square test with factors of group (Huperzine A, placebo) and occurrence of seizure (yes, no) was performed. A permutation test was the used to assess the effect of Huperzine A on the prevalence of seizures.|Chi-squared test and permutation test|||||||0.48
71020359|NCT01676311|141547658|SUPERIORITY|||||||0.44||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of behavioral side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of behavioral side effects.|Chi-squared test and permutation test|||Behavioral side effects statistical analysis||||0.44
71052964|NCT01781481|141610486|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Family/Caregiver and Health Service Pediatric INTERMED domain scores.||||<0.01
71052965|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and IBD Disease Severity at Diagnosis||||>0.05
71052966|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and IBD Disease Severity (at time of Study Participation).||||<0.01
71052967|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Functional Disability Index (child rating).||||<0.01
71052968|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Functional Disability Index (parent rating).||||<0.01
71052969|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Impact Quality of Life: General Well Being scale.||||<0.01
71052970|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Number of Surgeries.||||>0.05
71052971|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Number of Courses of Prednisone.||||>0.05
71052972|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Use of Immunomodulators.||||>0.05
71020360|NCT01676311|141547658|SUPERIORITY|||||||0.81||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of cardiac-respiratory side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects.|Chi-squared test and permutation test|||Cardiac-respiratory side effects statistical analysis||||0.81
71020361|NCT01676311|141547658|SUPERIORITY|||||||0.81||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of dermatological side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of dermatological side effects.|Chi-squared test and permutation test|||Dermatological side effects statistical analysis||||0.81
71052973|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Use of ant-TNFa medications.||||>0.05
71052974|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Disease Severity at Diagnosis.||||>0.05
71052975|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Disease Severity at time of study participation (Pediatric INTERMED interview).||||>0.05
71052976|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Functional Disability Index (Child Report)||||>0.05
71052977|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Functional Disability Index (Parent)||||<0.01
71020362|NCT01676311|141547658|SUPERIORITY|||||||0.73||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of gastrointestinal side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects.|Chi-squared test and permutation test|||Gastrointestinal side effects statistical analysis||||0.73
71020363|NCT01676311|141547658|SUPERIORITY|||||||0.54||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of genitourinary/neurological side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects|Chi-squared test and permutation test|||Genitourinary/neurological side effects statistical analysis||||0.54
71020364|NCT01676311|141547658|SUPERIORITY|||||||0.27||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of hematological side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects.|Chi-squared test and permutation test|||Hematological side effects statistical analysis||||0.27
71020365|NCT01676311|141547658|SUPERIORITY|||||||0.41||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of musculoskeletal side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects.|Chi-squared test and permutation test|||Musculoskeletal side effects statistical analysis||||0.41
71020366|NCT01676311|141547658|SUPERIORITY|||||||1||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of neurological side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects.|Chi-squared test and permutation test|||Neurological side effects statistical analysis||||1.00
71020367|NCT01223196|141547666|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Mann-Whitney test was used to test differences in M/I. Statistical Analysis applies to (M/I) between Pioglitazone and Placebo after 6 months.||Mann-Whitney test was used to test differences in whole body insulin sensitivity (M/I) between groups. Treatment-induced changes were examined by Wilcoxon's rank test. Data were analyzed using SPSS 20 (Statistical Package for Social Sciences 20), Chicago, IL, USA).||||0.04
71020368|NCT01223196|141547666|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Wilcoxon (Mann-Whitney)|Mann-Whitney test was used to test differences in whole body insulin sensitivity (M/I) between groups.||||||0.05
71020369|NCT01223196|141547667|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Mann-Whitney test was used to test differences in TACE activity in skeletal muscle between groups.||Mann-Whitney test was used to test differences in TACE activity in skeletal muscle between groups. Treatment-induced changes were examined by Wilcoxon's rank test. Data were analyzed using SPSS 20 (Statistical Package for Social Sciences, Chicago, IL, USA).||||<0.05
71020370|NCT01223196|141547667|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|Statistical Analysis applies toTNF (Tumor Necrosis Factor) alpha converting enzyme (TACE) activity between Pioglitazone and Placebo after 6 months.||Statistical analysis 2 also used 2-sided t-test similar to Statistical analysis -1||||<0.05
70851307|NCT00669409|141190542|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|11.6|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-5.1|28.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||28.3|-5.1|
70851308|NCT00669409|141190542|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.5|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-32.1|1.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.1|-32.1|
70851309|NCT00669409|141190542|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-13.5|19.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||19.7|-13.5|
71020371|NCT01223196|141547668|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Mann-Whitney test was used to test differences in Heamoglobin A1c between groups.||Mann-Whitney test was used to test differences Haemoglobin A1C between groups. Treatment-induced changes were examined by Wilcoxon's rank test. Data were analyzed using SPSS 20 (Statistical Package for Social Sciences, Chicago, IL, USA).||||<0.05
71020372|NCT00323271|141547669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.108||||0.911|TWO_SIDED|95.0|-2.106|1.888|||t-test, 2 sided|||||1.888|-2.106|.911
71052978|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Impact Quality of Life: General Well-Being.||||>0.05
71052979|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Number of Surgeries.||||>0.05
71052980|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Number of Courses of Prednisone.||||>0.05
71052981|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\< 0.05.|Spearman Correlation Coefficent|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Use of Immunomodulators (azathioprine or methotrexate)||||<0.05
70851310|NCT00669409|141190542|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-23.1|9.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.7|-23.1|
70851311|NCT00669409|141190542|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.9|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-40.7|2.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.9|-40.7|
70851312|NCT00669409|141190543|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|12.3|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-4.4|29.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||29.0|-4.4|
70851313|NCT00669409|141190543|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.2|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-27.8|5.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.4|-27.8|
70851314|NCT00669409|141190543|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-13.2|20.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.1|-13.2|
70851315|NCT00669409|141190543|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-23.9|9.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.0|-23.9|
71052982|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and use of anti-TNFa medications.||||>0.05
71052983|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Disease Severity at Diagnosis."||||>0.05
71052984|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current Biological) and IBD Disease Severity at time of study participation."||||<0.01
71052985|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current Biological) and Functional Disability Index (child rating)."||||<0.01
70851316|NCT00669409|141190543|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.6|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-40.4|3.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.2|-40.4|
70851317|NCT00669409|141190544|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|11.2|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-5.5|27.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||27.9|-5.5|
70851318|NCT00669409|141190544|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.6|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-26.3|7.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.0|-26.3|
70851319|NCT00669409|141190544|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-14.7|18.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||18.5|-14.7|
70851320|NCT00669409|141190544|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-23.6|9.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.2|-23.6|
70851321|NCT00669409|141190544|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-20.4|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-42.2|1.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.4|-42.2|
70851322|NCT00669409|141190545|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|13.5|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-3.2|30.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||30.2|-3.2|
71052986|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current Biological) and Functional Disability Index (Parent Rating)"||||<0.01
71052987|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current Biological) and Impact Quality of Life: General Well-Being Scale"||||<0.01
71052988|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Number of Surgeries"||||>0.05
71052989|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Number of Courses of Prednisone."||||>0.05
70932398|NCT02307682|141364358|OTHER||Difference in proportions|-7.1|||||TWO_SIDED|95.0|-12.5|-1.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-1.8|-12.5|
70932399|NCT02307682|141364358|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-6.0|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||4.0|-6.0|
71106257|NCT04464473|141719406|SUPERIORITY|||||||0.2146|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and subsystem (temporal, contextual, sensorimotor control) on overall BOLD activation.||||||0.2146
70932400|NCT02307682|141364358|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-6.3|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||3.9|-6.3|
70932401|NCT02307682|141364358|OTHER||Difference in proportions|-5.4|||||TWO_SIDED|95.0|-10.1|-0.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-0.4|-10.1|
70932402|NCT02307682|141364358|OTHER||Difference in proportions|-7.3|||||TWO_SIDED|95.0|-12.2|-2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-2.3|-12.2|
70932403|NCT02307682|141364358|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-5.2|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.3|-5.2|
70932404|NCT02307682|141364358|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-5.8|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||3.5|-5.8|
70932405|NCT02307682|141364358|OTHER||Difference in proportions|-3.4|||||TWO_SIDED|95.0|-8.4|1.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||1.8|-8.4|
70932406|NCT02307682|141364358|OTHER||Difference in proportions|-3.3|||||TWO_SIDED|95.0|-8.5|1.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||1.5|-8.5|
70932407|NCT02307682|141364358|OTHER||Difference in proportions|-4.7|||||TWO_SIDED|95.0|-9.8|0.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||0.2|-9.8|
70932408|NCT02307682|141364358|OTHER||Difference in proportions|-5.4|||||TWO_SIDED|95.0|-10.4|-0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||-0.7|-10.4|
70932409|NCT02307682|141364358|OTHER||Difference in proportions|-2.2|||||TWO_SIDED|95.0|-7.4|3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.0|-7.4|
70932410|NCT02307682|141364358|OTHER||Difference in proportions|-6.0|||||TWO_SIDED|95.0|-11.0|-1.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||-1.1|-11.0|
70932411|NCT02307682|141364358|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-4.9|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||5.1|-4.9|
70932412|NCT02307682|141364358|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-7.6|1.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||1.4|-7.6|
71052990|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Use of Immunomodulators."||||>0.05
71052991|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Use of anti-TNFa Medications."||||>0.05
71106258|NCT04464473|141719406|SUPERIORITY|||||||0.1541|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and temporal control on BOLD activation||||||0.1541
71106259|NCT04464473|141719406|SUPERIORITY|||||||0.6657|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and contextual control on BOLD activation||||||0.6657
71020373|NCT00323271|141547670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.644||||0.32|TWO_SIDED|95.0|-1.058|2.345||Multiple imputation used to account for missing variables; pre-treatment rating and years of MS pain were covariates|ANCOVA|||||2.345|-1.058|0.320
71020374|NCT05180630|141547680|OTHER|||||||0.012||||||When p-value is adjusted for multiple comparisons, the level of statistical significance must be \</= to 0.01666667 (.05/3). Comparisons were total mean scores for Open dome condition, Vented dome condition, and Custom earmolds with dynamic venting|ANOVA|||Treatment order was not analyzed. A repeated measures ANOVA was performed to compare the effect of the coupling conditions on sound quality ratings for streamed music, but there was no analysis between groups.||||0.012
71020375|NCT05180630|141547681|OTHER|||||||0.154||||||When p-value is adjusted for multiple comparisons, the level of statistical significance must be \</= to 0.01666667 (.05/3).|ANOVA|||Treatment order was not analyzed. A repeated measures ANOVA was performed to compare the effect of the coupling conditions on sound quality ratings for own voice, but there was no analysis between groups.||||0.154
71020376|NCT03496207|141547722|SUPERIORITY||Difference in Least Squares Means|-151.1|STANDARD_ERROR_OF_MEAN|49.53||0.003|TWO_SIDED|95.0|-249.59|-52.63|||ANCOVA|ANCOVA was used to compare change from baseline values with randomization stratification factor (WHO functional class) and baseline PVR as covariate.||Analysis based on calculated LS means.||-52.63|-249.59|0.0030
71020377|NCT03496207|141547722|SUPERIORITY||Difference in Least Squares Means|-269.4|STANDARD_ERROR_OF_MEAN|48.48|<|0.0001|TWO_SIDED|95.0|-365.81|-173.03|||ANCOVA|ANCOVA was used to compare change from baseline values with randomization stratification factor (WHO functional class) and baseline PVR as covariate.||Analysis based on calculated LS means.||-173.03|-365.81|<.0001
71020378|NCT03496207|141547723|SUPERIORITY||Difference in Least Squares Means|-13.9|STANDARD_ERROR_OF_MEAN|50.95||0.7851|TWO_SIDED|95.0|-113.85|86.06|||ANCOVA|ANCOVA was used to compare change from baseline values with randomization stratification factor (WHO functional class) and baseline PVR as covariate.||Analysis based on calculated LS means.||86.06|-113.85|0.7851
71020379|NCT03496207|141547724|SUPERIORITY||Multiple Imputation Mean Difference|-223.2|STANDARD_ERROR_OF_MEAN|57.45|<|0.0001|TWO_SIDED|95.0|-335.83|-110.49||Comparison of baseline and final value|ANCOVA||Standard multiple imputations are done with imputed values that are within the range of the minimum and maximum observed values using linear regression including baseline measurements.|||-110.49|-335.83|<.0001
71020380|NCT02164539|141547745|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.103||||0.024|TWO_SIDED|95.0|0.014|0.193|||Final step dose response model|||||0.193|0.014|0.024
71052992|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05. The P-Value indicated above was found for all the correlations which were examined.|Spearman Correlation Coefficient|||"Correlations between Pediatric INTERMED Diagnostic Dilemma Item (Historical Biological) and Functional Disability Index (Parent) and each of the following variables: Disease Severity at Diagnosis, Disease Severity at Interview, Functional Disability Index - Child, Functional Disability Index- Parent, Impact Quality of Life: General Well Being, Number of Surgeries, Number of Courses of Prednisone, Use of Immunomodulators, Use of Anti-TNFa Medications."||||>0.05
71052993|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and IBD Disease Severity at Diagnosis."||||>0.05
71020381|NCT02164539|141547745|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.103||||0.024|TWO_SIDED|95.0|0.014|0.193|||Final step dose response model|||||0.193|0.014|0.024
71020382|NCT02164539|141547745|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.103||||0.024|TWO_SIDED|95.0|0.014|0.193|||Final step dose response model|||||0.193|0.014|0.024
71020383|NCT02164539|141547745|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.103||||0.024|TWO_SIDED|95.0|0.014|0.193|||Final step dose response model|||||0.193|0.014|0.024
71020384|NCT02164539|141547745|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.073||||0.152|TWO_SIDED|95.0|-0.027|0.172|||Final dose response model|||||0.172|-0.027|0.152
71020385|NCT02164539|141547746|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.01|TWO_SIDED|95.0|-1.7|-0.2|||ANCOVA|||||-0.2|-1.7|0.010
71020386|NCT02164539|141547746|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1||||0.004|TWO_SIDED|95.0|-1.9|-0.4|||ANCOVA||Statistical analysis presented for daily rescue medication use.|||-0.4|-1.9|0.004
71020387|NCT02164539|141547746|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.083|TWO_SIDED|95.0|-1.4|0.1|||ANCOVA||Statistical analysis presented for daily rescue medication use.|||0.1|-1.4|0.083
71020388|NCT02164539|141547746|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.014|TWO_SIDED|95.0|-1.5|-0.2|||ANCOVA||Statistical analysis presented for daily rescue medication use.|||-0.2|-1.5|0.014
71020389|NCT02164539|141547746|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.031|TWO_SIDED|95.0|-1.4|-0.1|||ANCOVA||Statistical analysis presented for daily rescue medication use.|||-0.1|-1.4|0.031
71020390|NCT02164539|141547747|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.1|||<|0.001|TWO_SIDED|95.0|-4.6|-1.7|||ANCOVA|||||-1.7|-4.6|<0.001
71020391|NCT02164539|141547747|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0|||<|0.001|TWO_SIDED|95.0|-4.5|-1.6|||ANCOVA|||||-1.6|-4.5|<0.001
71106260|NCT04464473|141719406|SUPERIORITY|||||||0.5619|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), temporal control, and contextual control on BOLD activation||||||0.5619
71020392|NCT02164539|141547747|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.007|TWO_SIDED|95.0|-3.4|-0.6|||ANCOVA|||||-0.6|-3.4|0.007
71020393|NCT02164539|141547747|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.002|TWO_SIDED|95.0|-3.2|-0.7|||ANCOVA|||||-0.7|-3.2|0.002
71020394|NCT02164539|141547747|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.009|TWO_SIDED|95.0|-2.9|-0.4|||ANCOVA|||||-0.4|-2.9|0.009
71020395|NCT02164539|141547748|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.1||||0.004||95.0|5.9|30.3|||ANCOVA|||||30.3|5.9|0.004
71020396|NCT02164539|141547748|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.8|||<|0.001|TWO_SIDED|95.0|9.4|34.1|||ANCOVA|||||34.1|9.4|<0.001
71020397|NCT02164539|141547748|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.7||||0.001|TWO_SIDED|95.0|7.7|31.7|||ANCOVA|||||31.7|7.7|0.001
71020398|NCT02164539|141547748|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.8|||<|0.001|TWO_SIDED|95.0|14.1|35.4|||ANCOVA|||||35.4|14.1|<0.001
71020399|NCT02164539|141547748|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.5|||<|0.001|TWO_SIDED|95.0|8.0|29.1|||ANCOVA|||||29.1|8.0|<0.001
71020400|NCT02164539|141547749|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.045||||0.264|TWO_SIDED|95.0|-0.034|0.125|||ANCOVA|||||0.125|-0.034|0.264
71020401|NCT02164539|141547749|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.328|TWO_SIDED|95.0|-0.041|0.121|||ANCOVA|||||0.121|-0.041|0.328
71020402|NCT02164539|141547749|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.025||||0.534|TWO_SIDED|95.0|-0.054|0.103|||ANCOVA|||||0.103|-0.054|0.534
71020403|NCT02164539|141547749|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.005||||0.895|TWO_SIDED|95.0|-0.065|0.075|||ANCOVA|||||0.075|-0.065|0.895
71020404|NCT02164539|141547749|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.076||||0.031|TWO_SIDED|95.0|0.007|0.146|||ANCOVA|||||0.146|0.007|0.031
71020405|NCT02164539|141547750|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.088||||0.019|TWO_SIDED|95.0|-0.162|-0.014|||ANCOVA|||||-0.014|-0.162|0.019
71020406|NCT02164539|141547750|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.091||||0.017|TWO_SIDED|95.0|-0.165|-0.016|||ANCOVA|||||-0.016|-0.165|0.017
71020407|NCT02164539|141547750|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.089||||0.017|TWO_SIDED|95.0|-0.162|-0.016|||ANCOVA|||||-0.016|-0.162|0.017
71020408|NCT02164539|141547750|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.066|TWO_SIDED|95.0|-0.124|0.004|||ANCOVA|||||0.004|-0.124|0.066
71020409|NCT02164539|141547750|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.163|||<|0.001|TWO_SIDED|95.0|-0.227|-0.099|||ANCOVA|||||-0.099|-0.227|<0.001
71052994|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and IBD Disease Severity at time of study participation."||||<0.05
71020410|NCT01255722|141547751|NON_INFERIORITY_OR_EQUIVALENCE|The clinical non-inferiority margin was set to -10% maximum difference with the best comparator (i.e. iopromide).|Mean Difference (Final Values)|-0.033||||0.05|TWO_SIDED|95.0|-0.088|0.021|||Chi-squared|||Iobitridol was compared to the best of the two comparators. The two-sided 95% confidence interval (CI) of the difference between both proportions (Iobitridol - Comparator) was computed and the lower limit of the CI compared to the clinical non-inferiority limit in the study. The non-inferiority of iobitridol over the best comparator was established if the lower limit of the two-sided 95% CI was equal to or higher than the clinical non-inferiority limit.||0.021|-0.088|0.05
71020411|NCT01255722|141547752|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Fisher Exact|||||||0.750
71020412|NCT01255722|141547754|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Fisher Exact|||||||0.001
71020413|NCT01255722|141547755|SUPERIORITY_OR_OTHER|||||||0.109|TWO_SIDED||||||Fisher Exact|||||||0.109
71020414|NCT01255722|141547756|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Fisher Exact|||||||0.09
71020415|NCT02139306|141547852|SUPERIORITY||Mean Difference (Net)|0.597|STANDARD_ERROR_OF_MEAN|0.957||0.5336|TWO_SIDED|95.0|-1.2881|2.4813|||Mixed-model, repeated-measures|||||2.4813|-1.2881|0.5336
71020416|NCT02139306|141547853|SUPERIORITY||Rate ratio|0.8567|STANDARD_ERROR_OF_MEAN|0.1577||0.4008|TWO_SIDED|95.0|0.5973|1.2288|||Negative binomial regression|||||1.2288|0.5973|0.4008
71020417|NCT02139306|141547854|SUPERIORITY||Mean Difference (Net)|0.272|STANDARD_ERROR_OF_MEAN|1.93||0.8881|TWO_SIDED|95.0|-3.5292|4.0731|||Mixed-model, repeated measures|||||4.0731|-3.5292|0.8881
71020418|NCT02139306|141547855|SUPERIORITY||Mean Difference (Net)|-0.065|STANDARD_ERROR_OF_MEAN|0.1312||0.6208|TWO_SIDED|95.0|-0.3233|0.1934|||Mixed-model, repeated measures|||||0.1934|-0.3233|0.6208
71020419|NCT03909971|141547864|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71020420|NCT04583592|141547898|SUPERIORITY|||||||0.787||||||\<0.05|Chi-squared|||||||0.787
71020421|NCT03033069|141547926|SUPERIORITY||Least Squares (LS ) Mean Difference|-5.99|||=|0.0021|TWO_SIDED|95.0|-9.79|-2.19|||Mixed Model Repeated Measures (MMRM)|||MMRM analysis with an unstructured (UN) variance covariance structure was performed. The model included fixed class-effect terms for treatment, trial site, type of trauma (combat related Yes/No), visit week, and an interaction term of treatment by visit week and included the interaction term of baseline values of CAPS-5 total score by visit week as a covariate.||-2.19|-9.79|=0.0021
71020422|NCT03033069|141547926|SUPERIORITY||LS Mean Difference|-1.74|||=|0.3868|TWO_SIDED|95.0|-5.7|2.22|||MMRM|||MMRM analysis with an UN variance covariance structure was performed. The model included fixed class-effect terms for treatment, trial site, type of trauma (combat related Yes/No), visit week, and an interaction term of treatment by visit week and included the interaction term of baseline values of CAPS-5 total score by visit week as a covariate.||2.22|-5.70|=0.3868
71020423|NCT03033069|141547926|SUPERIORITY||LS Mean Difference|-0.91|||=|0.6399|TWO_SIDED|95.0|-4.74|2.92|||MMRM|||MMRM analysis with an UN variance covariance structure was performed. The model included fixed class-effect terms for treatment, trial site, type of trauma (combat related Yes/No), visit week, and an interaction term of treatment by visit week and included the interaction term of baseline values of CAPS-5 total score by visit week as a covariate.||2.92|-4.74|=0.6399
71020424|NCT03033069|141547926|SUPERIORITY||LS Mean Difference|-5.08|||=|0.0106|TWO_SIDED|95.0|-8.96|-1.2|||MMRM|||MMRM analysis with an UN variance covariance structure was performed. The model included fixed class-effect terms for treatment, trial site, type of trauma (combat related Yes/No), visit week, and an interaction term of treatment by visit week and included the interaction term of baseline values of CAPS-5 total score by visit week as a covariate.||-1.20|-8.96|=0.0106
71020425|NCT03033069|141547926|SUPERIORITY||LS Mean Difference|-4.24|||=|0.0384|TWO_SIDED|95.0|-8.26|-0.23|||MMRM|||MMRM analysis with an UN variance covariance structure was performed. The model included fixed class-effect terms for treatment, trial site, type of trauma (combat related Yes/No), visit week, and an interaction term of treatment by visit week and included the interaction term of baseline values of CAPS-5 total score by visit week as a covariate.||-0.23|-8.26|=0.0384
71020426|NCT00430638|141547927|SUPERIORITY_OR_OTHER||||||<|0.0001||||||No multiplicity adjustments|ANCOVA|The ANCOVA model included randomized treatment and baseline cuff blood pressure stage as factors and study baseline systolic BP value as a covariate.||Null hypothesis: For the entire efficacy population, Olmesartan had the same effect on change from baseline in systolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
71020427|NCT00430638|141547928|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|The ANCOVA Model included randomized treatment and baseline cuff BP stage as factors and study baseline diastolic BP as a covariate.||Null hypothesis: For the entire efficacy population, Olmesartan had the same effect on change from baseline in diastolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
71020428|NCT00430638|141547929|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (male systolic blood pressure (SBP)): For the male efficacy population, Olmesartan had the same effect on change from baseline in systolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
71020429|NCT00430638|141547929|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Males - diastolic blood pressure (DBP)): For the male efficacy population, Olmesartan had the same effect on change from baseline in diastolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
71020430|NCT00430638|141547930|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Systolic blood pressure (SBP) - females): For the female efficacy population, Olmesartan had the same effect on change from baseline in systolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
70932413|NCT02307682|141364358|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-5.3|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||5.1|-5.3|
71020431|NCT00430638|141547930|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) - females): For the female efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
71020432|NCT00430638|141547931|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis(Systolic blood pressure (SBP) - less than 65 years of age): For the efficacy population \< 65 years of age, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
71020433|NCT00430638|141547931|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) - less than 65 years of age): For the efficacy population \< 65 years of age, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
71020434|NCT00430638|141547932|SUPERIORITY_OR_OTHER|||||||0.0125||95.0|||||ANCOVA|||Null hypothesis (Systolic blood pressure (SBP) - \> or equal to 65 years old): For the efficacy population \> or = to 65 years of age, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||0.0125
71020435|NCT00430638|141547932|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) \> or equal to 65): For the efficacy population \> or = to 65 years of age, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||0.0006
71020436|NCT00430638|141547933|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Systolic blood pressure (SBP) - Black participants): For the Black efficacy population, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
71020437|NCT00430638|141547933|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) - Black participants): For the Black efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
71020438|NCT00430638|141547934|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis(Systolic blood pressure (SBP) - non-Black participants): For the Non-Black efficacy population, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
71020439|NCT00430638|141547934|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis(Diastolic blood pressure (DBP) - non-Black participants): For the Non-Black efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
71020440|NCT00430638|141547935|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis(Systolic blood pressure (SBP) - Stage 1 hypertensive participants): For the Stage 1 efficacy population, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
71020441|NCT00430638|141547935|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) - Stage 1 hypertensive participants): For the Stage 1 efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
71020442|NCT00430638|141547936|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Systolic blood pressure (SBP) - Stage 2 hypertensive participants): For the Stage 2 efficacy population, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
71020443|NCT00430638|141547936|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) - Stage 2 hypertensive participants): For the Stage 2 efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
70932414|NCT02307682|141364358|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-8.5|0.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||0.8|-8.5|
70932415|NCT02307682|141364359|OTHER||Difference in proportions|-6.7|||||TWO_SIDED|95.0|-14.1|0.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||0.2|-14.1|
70932416|NCT02307682|141364359|OTHER||Difference in proportions|-7.4|||||TWO_SIDED|95.0|-15.3|-0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||-0.3|-15.3|
70932417|NCT02307682|141364359|OTHER||Difference in proportions|-9.3|||||TWO_SIDED|95.0|-16.6|-2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||-2.2|-16.6|
71020444|NCT00802529|141547953|SUPERIORITY_OR_OTHER|||||||0.271||||||P-value for Drug x Time interaction.|ANOVA|Time: 2 degrees of freedom (Baseline vs 18-24 months) Drug: 2 degrees of freedom (Gentamicin vs steroid)||||||0.271
71020445|NCT00802529|141547954|SUPERIORITY_OR_OTHER|||||||0.964||||||P-value for Drug x Time interaction.|ANOVA|Time: 6 degrees of freedom (Baseline, 1, 2, 6, 12, 18 and 24 months) Drug: 2 degrees of freedom (Gentamicin vs steroid)||||||0.964
71020446|NCT00802529|141547955|SUPERIORITY_OR_OTHER|||||||0.128||||||P-value for Drug x Time interaction.|ANOVA|Time: 5 degrees of freedom (Baseline, 1, 2, 6, 12 and 24 months) Drug: 2 degrees of freedom (Gentamicin vs steroid)||||||0.128
71020447|NCT01791127|141547970|SUPERIORITY|The primary endpoint 1 hypothesis was evaluated by performing an exact, binomial test comparing a binomial proportion (AEFR at 12 months) to 94.0%, with Type I error (alpha) or 0.025 and power of 80%.|||||<|0.0001|||||||Exact, binomial|||||||<0.0001
71020448|NCT01791127|141547971|SUPERIORITY||||||<|0.0001|||||||Exact, binomial|||The primary endpoint 2 hypothesis was evaluated by performing an exact, binomial test comparing a binomial proportion (AEFR at 12 months) to 94.0%, with Type I error (alpha) or 0.025 and power of 80%.||||<0.0001
71020449|NCT01791127|141547972|SUPERIORITY||||||<|0.0001|||||||Exact, binomial|||The primary endpoint 3 hypothesis was evaluated by performing an exact, binomial test comparing a binomial proportion (successful sensing and pacing rate at 12 months) to 97.0%, with Type I error (alpha) or 0.025 and power of 80%.||||<0.0001
71052995|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Functional Disability Index (Child Rating)"||||<0.05
70932418|NCT02307682|141364359|OTHER||Difference in proportions|-12.1|||||TWO_SIDED|95.0|-19.7|-5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||-5.4|-19.7|
70932419|NCT02307682|141364359|OTHER||Difference in proportions|-8.2|||||TWO_SIDED|95.0|-14.8|-1.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-1.6|-14.8|
70932420|NCT02307682|141364359|OTHER||Difference in proportions|-10.2|||||TWO_SIDED|95.0|-17.4|-3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-3.9|-17.4|
70932421|NCT02307682|141364359|SUPERIORITY||Difference in proportions|-10.2||||0.003|TWO_SIDED|95.0|-17.3|-2.5||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-2.5|-17.3|0.0030
70932422|NCT02307682|141364359|SUPERIORITY||Difference in proportions|-18.2|||<|0.0001|TWO_SIDED|95.0|-25.3|-10.9||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-10.9|-25.3|<0.0001
70932423|NCT02307682|141364359|OTHER||Difference in proportions|12.0|||||TWO_SIDED|95.0|5.2|19.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||19.0|5.2|
70932424|NCT02307682|141364359|OTHER||Difference in proportions|11.1|||||TWO_SIDED|95.0|3.8|18.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||18.2|3.8|
70932425|NCT02307682|141364359|OTHER||Difference in proportions|-10.6|||||TWO_SIDED|95.0|-17.7|-3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-3.1|-17.7|
71020450|NCT01791127|141547973|SUPERIORITY|||||||||||||||||The primary endpoint 4 hypothesis was evaluated by performing an exact, binomial test comparing a binomial proportion (AEFR at 5 years) to 92.5%, with Type I error (alpha) or 0.025 and power of 80%.|On April 15, 2019, BIOTRONIK received FDA approval to transition the ongoing SIELLO Post Approval Registry to a new EP PASSION real-world data methodology. As of study closure, the number of subjects with complete data required to perform the hypothesis test was not met. Therefore, this outcome measure was not analyzed.|||
71020451|NCT03471182|141548011|SUPERIORITY|||||||0.035||||||Primary hypothesis of a group difference (i.e., CUD vs HHC-PET participants) in mGluR5 availability was assessed as the significance level of the fixed-effect of group at a threshold of p\<0.05.|Mixed Models Analysis|||Outcome Measure Data were tested using a single linear mixed effects model. The 9 regions of interest (i.e., all 9 Rows of the Outcome Measure Data) were included in the model as a within-subjects factor for the fixed-effect of region. Group (i.e., CUD, HHC-PET) was included in the model as a between-subjects factor for the fixed-effect of group. The model also included the region-by-group interaction term and a factor to model the random-effect of participant.||||0.035
71052996|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Functional Disability Index (parent rating)."||||>0.05
71052997|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Impact Quality of LIfe: General Well-Being Scale"||||<0.01
70932426|NCT02307682|141364359|OTHER||Difference in proportions|-23.2|||||TWO_SIDED|95.0|-30.5|-16.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-16.1|-30.5|
70932427|NCT02307682|141364359|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-4.8|9.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||9.0|-4.8|
71052998|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Number of Surgeries."||||>0.05
71052999|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Number of Courses of Prednisone."||||>0.05
71053000|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Use of Immunomodulators. ."||||>0.05
71106261|NCT04464473|141719406|SUPERIORITY|||||||0.5148|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), temporal control, and subsystem (temporal, contextual, sensorimotor) on BOLD activation||||||0.5148
70932428|NCT02307682|141364359|OTHER||Difference in proportions|-3.9|||||TWO_SIDED|95.0|-11.8|2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.5|-11.8|
71106262|NCT04464473|141719406|SUPERIORITY|||||||0.5428|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), contextual control, and subsystem (temporal, contextual, sensorimotor) on BOLD activation||||||0.5428
71020452|NCT03471182|141548012|SUPERIORITY|Outcome Measure Data were tested using a single linear mixed effects model. The 4 brain networks of interest (i.e., all 4 Rows of the Outcome Measure Data) were included in the model as a within-subjects factor for the fixed-effect of network. Group (i.e., CUD, HC-MRI) was included in the model as a between-subjects factor for the fixed-effect of group. The model also included the network-by-group interaction term and a factor to model the random-effect of participant.||||||0.024||||||Primary hypothesis of group differences (i.e., CUD vs HC-MRI participants) in functional brain network engagement was assessed as the significance level of the fixed-effect of group at a threshold of p\<0.05.|Mixed Models Analysis|||||||0.024
71020453|NCT03471182|141548013|SUPERIORITY|||||||0.87||||||Primary hypothesis of group differences (i.e., CUD vs HC-MRI participants) in fALFF was assessed as the significance level of the fixed-effect of group at a threshold of p\<0.05.|Mixed Models Analysis|||Outcome Measure Data were tested using a single linear mixed effects model. The 5 brain networks of interest (i.e., all 5 Rows of the Outcome Measure Data) were included in the model as a within-subjects factor for the fixed-effect of network. Group (i.e., CUD, HC-MRI) was included in the model as a between-subjects factor for the fixed-effect of group. The model also included the network-by-group interaction term and a factor to model the random-effect of participant.||||0.870
71020454|NCT04440163|141548015|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was greater than (\>) minus (-)10 percent (%), the non-inferiority was concluded.|Difference in percentage of participants|2.5|||||TWO_SIDED|95.0|-0.2|6.0|||Based on Miettinen and Nurminen method.|||MenA||6.0|-0.2|
71020455|NCT04440163|141548015|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|41.0|||||TWO_SIDED|95.0|34.4|47.5||||||MenC||47.5|34.4|
71020456|NCT04440163|141548015|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|24.3|||||TWO_SIDED|95.0|18.8|30.4||||||MenW||30.4|18.8|
71020457|NCT04440163|141548015|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|23.8|||||TWO_SIDED|95.0|18.0|30.1||||||MenY||30.1|18.0|
71020458|NCT04440163|141548016|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|-3.2|||||TWO_SIDED|95.0|-6.5|0.5||||||MenA||0.5|-6.5|
71020459|NCT04440163|141548016|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|-0.9|||||TWO_SIDED|95.0|-4.6|3.3||||||MenC||3.3|-4.6|
71020460|NCT04440163|141548016|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|0.7|||||TWO_SIDED|95.0|-2.2|4.3||||||MenW||4.3|-2.2|
71020461|NCT04440163|141548016|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|-0.7|||||TWO_SIDED|95.0|-4.6|3.8||||||MenY||3.8|-4.6|
71053001|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Use of anti-TNFa Medications"||||>0.05
71053002|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Disease Severity at Diagnosis."||||>0.05
71053003|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Disease Severity at time of study participation (Pediatric INTERMED interview)."||||>0.05
71053004|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Functional Disability Index (Child Rating)."||||>0.05
71053005|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Functional Disability Index (Parent Rating)"||||>0.05
71053006|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Impact Quality of Life: General Well-Being"||||>0.05
71106263|NCT04464473|141719406|SUPERIORITY|||||||0.1249|||||||ANOVA|Interaction of intervention, temporal control, contextual control, and subsystem on BOLD activation||||||0.1249
71106264|NCT04464473|141719407|SUPERIORITY|||||||0.9504|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and temporal control on error rate||||||0.9504
70932429|NCT02307682|141364359|OTHER||Difference in proportions|-4.5|||||TWO_SIDED|95.0|-12.0|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||3.1|-12.0|
70932430|NCT02307682|141364359|OTHER||Difference in proportions|-10.3|||||TWO_SIDED|95.0|-18.0|-3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||-3.2|-18.0|
70932431|NCT02307682|141364359|OTHER||Difference in proportions|-5.9|||||TWO_SIDED|95.0|-12.5|0.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||0.8|-12.5|
70932432|NCT02307682|141364359|OTHER||Difference in proportions|-9.2|||||TWO_SIDED|95.0|-16.2|-2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-2.4|-16.2|
70932433|NCT02307682|141364359|OTHER||Difference in proportions|-8.2|||||TWO_SIDED|95.0|-15.7|-0.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-0.6|-15.7|
70932434|NCT02307682|141364359|OTHER||Difference in proportions|-13.0|||||TWO_SIDED|95.0|-20.5|-5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-5.5|-20.5|
70932435|NCT02307682|141364359|OTHER||Difference in proportions|6.0|||||TWO_SIDED|95.0|-0.8|13.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||13.0|-0.8|
70932436|NCT02307682|141364359|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-7.5|6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||6.6|-7.5|
70932437|NCT02307682|141364359|SUPERIORITY||Difference in proportions|-10.5||||0.002|TWO_SIDED|95.0|-17.4|-3.3||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-3.3|-17.4|0.0020
70932438|NCT02307682|141364359|SUPERIORITY||Difference in proportions|-13.5||||0.0001|TWO_SIDED|95.0|-20.7|-6.1||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-6.1|-20.7|0.0001
70932439|NCT02307682|141364359|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-5.4|8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||8.1|-5.4|
71020462|NCT04440163|141548017|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|9.6|||||TWO_SIDED|95.0|4.2|15.2||||||||15.2|4.2|
71020463|NCT04440163|141548018|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|4.0|||||TWO_SIDED|95.0|-0.7|8.9||||||A22||8.9|-0.7|
71020464|NCT04440163|141548018|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|1.4|||||TWO_SIDED|95.0|-1.0|4.3||||||A56||4.3|-1.0|
71020465|NCT04440163|141548018|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|10.9|||||TWO_SIDED|95.0|5.2|16.6||||||B24||16.6|5.2|
71020466|NCT04440163|141548018|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage|7.3|||||TWO_SIDED|95.0|2.9|11.9||||||B44||11.9|2.9|
71020467|NCT04440163|141548050|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|1.7|||||TWO_SIDED|95.0|-1.0|5.3||||||MenA||5.3|-1.0|
71053007|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Number of Surgeries."||||>0.05
71053008|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Number of Courses of Prednisone since diagnosis."||||<0.05
71053009|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significiance is p\<0.01.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Use of Immunomodulators (azathioprine or methotrexate)."||||<0.01
71053010|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||<|0.01||||||The Threshold for significance is p\<0.05)|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Use of ant-TNFa Medications (infliximab or adalimumab)."||||<0.01
71053011|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Disease Severity at diagnosis."||||>0.05
71053012|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Disease Severity at study participation."||||<0.05
71053013|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Functional Disability Index (Child Rating)."||||<0.01
71053014|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.01.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Functional Disability Index (parent rating)."||||<0.01
71053015|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Impact Quality of Life: General Well Being Scale."||||<0.05
71053016|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Number of Surgeries."||||>0.05
71053017|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Number of Courses of Prednisone."||||>0.05
71053018|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Use of Immunomodulators (azathioprine or methotrexate)."||||<0.05
71106265|NCT04464473|141719407|SUPERIORITY|||||||0.7318|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), and temporal control on error rate||||||0.7318
71053019|NCT01781481|141610500|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Use of anti-TNFa Medications."||||>0.05
71053020|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Internalizing Problems (Child Behaviour Checklist).||||<0.01
71053021|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Externalizing Problems (Child Behaviour Checklist).||||<0.01
71053022|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Children's Depression Inventory: Total Score||||<0.01
71053023|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Multidimensional Anxiety Scale for Children: Total Score.||||<0.05
71053024|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Impact Quality of Life: Emotional Scale||||<0.01
71053025|NCT01781481|141610501|SUPERIORITY_OR_OTHER|||||||0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Social Competence Scale (Child Behaviour Checklist).||||0.01
71053026|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Activities Competence Scale (Child Behaviour Checklist).||||<0.05
71053027|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Academic Competence Scale (Child Behaviour Checklist).||||<0.01
71053028|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Impact Quality of Life: Social Scale||||<0.01
71053029|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Pediatric Inventory for Parents: Difficulty Score (parenting stress).||||<0.05
71053030|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Family Inventory of Life Events (family stress measure).||||<0.01
71053031|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Family Inventory of Resources for Management (family resources measure).||||<0.01
71106266|NCT04464473|141719407|SUPERIORITY|||||||0.8424|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and temporal control on error rate||||||0.8424
71106267|NCT04464473|141719407|SUPERIORITY|||||||0.7652|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), and temporal control on error rate||||||0.7652
71106268|NCT04464473|141719408|SUPERIORITY|||||||0.0266|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and contextual control on error rate||||||0.0266
71020468|NCT04440163|141548050|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|10.5|||||TWO_SIDED|95.0|3.0|17.9||||||MenC||17.9|3.0|
71106269|NCT04464473|141719408|SUPERIORITY|||||||0.2386|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return) and contextual control on error rate||||||0.2386
71020469|NCT04440163|141548050|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|6.3|||||TWO_SIDED|95.0|-0.1|13.1||||||MenW||13.1|-0.1|
71020470|NCT04440163|141548050|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|11.4|||||TWO_SIDED|95.0|5.0|18.2||||||MenY||18.2|5.0|
71053032|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Internalizing Problems (Child Behaviour Checklist).||||<0.01
71053033|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Externalizing Problems (Child Behaviour Checklist).||||<0.01
71053034|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Children's Depression Inventory: Total Score||||<0.01
71053035|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Multidimensional Anxiety Scale for Children: Total Score.||||<0.05
71053036|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Impact Quality of Life: Emotional Scale||||<0.01
71053037|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Social Competence Scale (Child Behaviour Checklist).||||<0.01
71053038|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Activities Competence Scale (Child Behaviour Checklist).||||<0.01
71106270|NCT04464473|141719408|SUPERIORITY|||||||0.4211|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and contextual control on error rate||||||0.4211
71020471|NCT04440163|141548051|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|-2.2|||||TWO_SIDED|95.0|-5.2|1.4||||||MenA||1.4|-5.2|
71106271|NCT04464473|141719408|SUPERIORITY|||||||0.7503|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return) and contextual control on error rate||||||0.7503
71106272|NCT04464473|141719409|SUPERIORITY|||||||0.0091|||||||ANOVA|Interaction of Visit (Baseline, MFG-cTBS, FPl-cTBS, S1), Temporal Control, and Contextual Control on error rate||||||0.0091
71053039|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Academic Competence Scale (Child Behaviour Checklist).||||<0.01
71053040|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Impact Quality of Life: Social Scale||||<0.01
71053041|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Pediatric Inventory for Parents: Difficulty Score (parenting stress).||||<0.01
71053042|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Family Inventory of Life Events (family stress measure).||||<0.01
71053043|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Family Inventory of Resources for Management (family resources measure).||||<0.01
71106273|NCT04464473|141719409|SUPERIORITY|||||||0.0045|||||||ANOVA|Interaction of Visit (Baseline, MFG-cTBS, FPl-cTBS, S1), phase (sub-task, return), Temporal Control, and Contextual Control on error rate||||||0.0045
71106274|NCT04464473|141719409|SUPERIORITY|||||||0.1082|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1), Temporal Control, and Contextual Control on error rate||||||0.1082
71106275|NCT04464473|141719409|SUPERIORITY|||||||0.0659|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1), phase (sub-task, return), Temporal Control, and Contextual Control on error rate||||||0.0659
71106276|NCT04464473|141719410|SUPERIORITY|||||||0.0211|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and temporal control in reaction time||||||0.0211
70932440|NCT02307682|141364359|OTHER||Difference in proportions|-4.9|||||TWO_SIDED|95.0|-11.8|1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||1.2|-11.8|
70932441|NCT02307682|141364359|OTHER||Difference in proportions|-3.2|||||TWO_SIDED|95.0|-10.3|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||3.7|-10.3|
71020472|NCT04440163|141548051|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|-1.3|||||TWO_SIDED|95.0|-4.9|2.9||||||MenC||2.9|-4.9|
71020473|NCT04440163|141548051|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|1.0|||||TWO_SIDED|95.0|-1.6|4.6||||||MenW||4.6|-1.6|
71053044|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Internalizing Problems (Child Behaviour Checklist).||||<0.01
71053045|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Externalizing Problems (Child Behaviour Checklist).||||<0.01
71053046|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Children's Depression Inventory: Total Score||||<0.01
71053047|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Multidimensional Anxiety Scale for Children: Total Score.||||>0.05
71053048|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Impact Quality of Life: Emotional Scale||||<0.01
71053049|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Social Competence Scale (Child Behaviour Checklist).||||<0.01
71053050|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Activities Competence Scale (Child Behaviour Checklist).||||<0.01
71053051|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Academic Competence Scale (Child Behaviour Checklist).||||<0.01
71053052|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Impact Quality of Life: Social Scale||||<0.01
71053053|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Pediatric Inventory for Parents: Difficulty Score (parenting stress).||||<0.01
71053054|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Family Inventory of Life Events (family stress measure).||||<0.01
71053055|NCT01781481|141610501|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Family Inventory of Resources for Management (family resources measure).||||<0.01
71053056|NCT01781481|141610502|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.33|||||TWO_SIDED|95.0|2.02|34.47||||||||34.47|2.02|
71053057|NCT01781481|141610503|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.52|||||TWO_SIDED|95.0|1.7|43.02||||||||43.02|1.70|
71020474|NCT04440163|141548051|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|0.6|||||TWO_SIDED|95.0|-3.0|5.0||||||MenY||5.0|-3.0|
71020475|NCT02229487|141548052|OTHER|||||||0.209|||||||Wilcoxon (Mann-Whitney)|||||||0.209
71053058|NCT01781481|141610504|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.27|||||TWO_SIDED|95.0|2.17|24.36||||||||24.36|2.17|
71053059|NCT01781481|141610505|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.79|||||TWO_SIDED|95.0|5.0|122.84||||||||122.84|5.00|
71053060|NCT01781481|141610506|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Number of Hospital Services involved in the child's care.||||<0.01
71053061|NCT01781481|141610506|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Number of Inpatient Hospitalizations since IBD diagnosis.||||<0.01
71053062|NCT01781481|141610506|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Number of Surgeries since IBD diagnosis.||||<0.01
71053063|NCT01781481|141610506|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Family Financial Well Being||||<0.01
71020476|NCT01954082|141548056|SUPERIORITY||Risk Ratio (RR)|1.41||||0.0095|TWO_SIDED|95.0|1.08|1.83||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson|Model adjusted for strata defined by center and gestational age.|In the risk ratio, the numerator represents the Inositol arm and the denominator represents the placebo arm. (RR\>1 implies that the risk of mortality and/or severe ROP is greater in the Inositol group compared to the Placebo group).|The null hypothesis is there is no treatment effect on the development of severe ROP and mortality.||1.83|1.08|0.0095
71020477|NCT01954082|141548057|SUPERIORITY||Risk Ratio (RR)|1.03||||0.6599|TWO_SIDED|95.0|0.91|1.16||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.|In the risk ratio, the numerator represents the Inositol arm and the denominator represents the placebo arm. (RR\>1 implies that the risk of BPD is greater in the Inositol group compared to the Placebo group).|The null hypothesis is there is no treatment effect on the incidence of BPD.||1.16|0.91|0.6599
71020478|NCT01954082|141548058|SUPERIORITY||Risk Ratio (RR)|1.05||||0.3883|TWO_SIDED|95.0|0.94|1.17||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.||The null hypothesis is there is no treatment effect on the incidence of BPD or on mortality due to BDP.||1.17|0.94|0.3883
71020479|NCT01954082|141548059|SUPERIORITY||Risk Ratio (RR)|1.53||||0.0306|TWO_SIDED|95.0|1.03|2.25||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.|In the risk ratio, the numerator represents the Inositol arm and the denominator represents the placebo arm. (RR\>1 implies that the risk of mortality prior to ROP endpoint is greater in the Inositol group compared to the Placebo group).|The null hypothesis is there is no treatment effect on survival to ROP endpoint.||2.25|1.03|0.0306
71020480|NCT01954082|141548060|SUPERIORITY||Risk Ratio (RR)|1.02||||0.7464|TWO_SIDED|95.0|0.91|1.14||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.||The null hypothesis is there is no treatment effect on the incidence of ROP||1.14|0.91|0.7464
71020481|NCT01954082|141548061|SUPERIORITY||Risk Ratio (RR)|0.98||||0.7598|TWO_SIDED|95.0|0.83|1.14||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.|In the risk ratio, the numerator represents the Inositol arm and the denominator represents the placebo arm. (RR\>1 implies that the risk of Type 2 ROP or more severe ROP is greater in the Inositol group compared to the Placebo group).|The null hypothesis is there is no treatment effect on the incidence of Type 2 ROP or more severe ROP.||1.14|0.83|0.7598
71106277|NCT04464473|141719410|SUPERIORITY|||||||0.4964|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), and temporal control in reaction time||||||0.4964
70932442|NCT02307682|141364359|OTHER||Difference in proportions|-6.9|||||TWO_SIDED|95.0|-14.1|0.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||0.4|-14.1|
71020482|NCT01954082|141548062|SUPERIORITY||Risk Ratio (RR)|1.04||||0.8133|TWO_SIDED|95.0|0.74|1.48||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.|In the risk ratio, the numerator represents the Inositol arm and the denominator represents the placebo arm. (RR\>1 implies that the risk of severe IVH is greater in the Inositol group compared to the Placebo group).|The null hypothesis is there is no treatment effect on the incidence severe IVH.||1.48|0.74|0.8133
71020483|NCT01453374|141548085|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Fisher Exact|||||||>0.05
71020484|NCT01453374|141548086|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Fisher Exact|||||||>0.05
71020485|NCT01453374|141548087|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Fisher Exact|||||||<0.05
71020486|NCT01453374|141548093|SUPERIORITY_OR_OTHER||||||<|0.1|TWO_SIDED||||||Fisher Exact|||||||<0.10
71053064|NCT01781481|141610506|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Access to Health Care Item (historical/health system) and Number of Hospital Services Involved in the Child's Care."||||>0.05
71053065|NCT01781481|141610506|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Access to Health Care Item (historical/health system) and Number of Hospitalizations since Child's IBD Diagnosis."||||<0.01
71053066|NCT01781481|141610506|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Access to Health Care Item (historical/health system) and Number of Surgeries since Diagnosis."||||<0.01
71053067|NCT01781481|141610506|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Access to Health Care Item (historical/health system) and Family Financial Well-Being."||||<0.01
71053068|NCT01781481|141610506|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Treatment Experience Item (historical/health system) and Number of Hospital Services Involved in the Child's Care."||||<0.01
71053069|NCT01781481|141610506|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Treatment Experience Item (historical/health system) and Number of Hospitalizations since Child's IBD Diagnosis."||||>0.05
71053070|NCT01781481|141610506|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Treatment Experience Item (historical/health system) and Number of Surgeries since child's diagnosis."||||>0.05
71053071|NCT01781481|141610506|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Treatment Experience Item (historical/health system) and Family Financial Well-Being."||||>0.05
71053072|NCT01781481|141610506|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Organization of Care Item (current/health system) and Number of Hospital Services Involved in the Child's Care."||||<0.01
70932443|NCT02307682|141364359|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-10.1|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.3|-10.1|
70932444|NCT02307682|141364359|OTHER||Difference in proportions|-7.1|||||TWO_SIDED|95.0|-14.0|-0.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||-0.6|-14.0|
70932445|NCT02307682|141364359|OTHER||Difference in proportions|-7.6|||||TWO_SIDED|95.0|-14.7|-0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-0.1|-14.7|
70932446|NCT02307682|141364359|OTHER||Difference in proportions|-12.1|||||TWO_SIDED|95.0|-19.5|-5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-5.4|-19.5|
70932447|NCT02307682|141364359|OTHER||Difference in proportions|7.2|||||TWO_SIDED|95.0|0.3|13.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||13.5|0.3|
71053073|NCT01781481|141610506|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Organization of Care Item (current/health system) and Number of Hospitalizations since IBD Diagnosis."||||>0.05
71053074|NCT01781481|141610506|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Organization of Care Item (current/health system) and Number of Surgeries since Child's IBD Diagnosis."||||>0.05
71053075|NCT01781481|141610506|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Organization of Care Item (current/health system) and Family Financial Well-Being."||||<0.01
70932448|NCT02307682|141364359|OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-4.9|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||8.4|-4.9|
70932449|NCT02307682|141364359|OTHER||Difference in proportions|-8.9|||||TWO_SIDED|95.0|-15.7|-1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-1.7|-15.7|
71053076|NCT01781481|141610506|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Coordination of Care Item (current/health system) and Number of Hospital Services Involved in the Child's Care."||||<0.01
71053077|NCT01781481|141610506|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Coordination of Care Item (current/health system) and Number of Hospitalizations since Child's IBD Diagnosis."||||>0.05
71053078|NCT01781481|141610506|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Coordination of Care Item (current/health system) and Number of Surgeries Child's IBD Diagnosis."||||>0.05
71053079|NCT01781481|141610506|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Coordination of Care Item (current/health system) and Family Financial Well Being."||||>0.05
71053080|NCT01781481|141610506|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Health System Impediments Item (vulnerability/health system) and Number of Hospital Services Involved in the Child's Care."||||>0.05
71053081|NCT01781481|141610506|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Health System Impediments Item (vulnerability/health system) and Number of Hospitalizations since Child's IBD Diagnosis. Services Involved in the Child's Care."||||<0.01
71053082|NCT01781481|141610506|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Health System Impediments Item (vulnerability/health system) and Number of Surgeries since Child's IBD Diagnosis."||||>0.05
71053083|NCT01781481|141610506|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Health System Impediments Item (vulnerability/health system) and Family Financial Well-Being."||||<0.01
71053084|NCT01781481|141610507|SUPERIORITY_OR_OTHER||Rsquare change statistic|0.08|||<|0.01|TWO_SIDED|||||p\<0.05 Threshold for statistical significance|Regression, Linear|||A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of hospital services involved in child's care. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.||||<0.01
71106278|NCT04464473|141719410|SUPERIORITY|||||||0.3129|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and temporal control in reaction time||||||0.3129
71106279|NCT04464473|141719410|SUPERIORITY|||||||0.5439|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), and temporal control in reaction time||||||0.5439
71106280|NCT04464473|141719411|SUPERIORITY|||||||0.0344|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and contextual control in reaction time||||||0.0344
71106281|NCT04464473|141719411|SUPERIORITY|||||||0.5113|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), and contextual control in reaction time||||||0.5113
71106282|NCT04464473|141719411|SUPERIORITY|||||||0.0301|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and contextual control in reaction time||||||0.0301
71106283|NCT04464473|141719411|SUPERIORITY|||||||0.6931|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), and contextual control in reaction time||||||0.6931
71106284|NCT04464473|141719412|SUPERIORITY|||||||0.0189|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), temporal control, and contextual control on reaction time||||||0.0189
71106285|NCT04464473|141719412|SUPERIORITY|||||||0.0763|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), temporal control, and contextual control on reaction time||||||0.0763
71106286|NCT04464473|141719412|SUPERIORITY|||||||0.9701|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), temporal control, and contextual control on reaction time||||||0.9701
71106287|NCT04464473|141719412|SUPERIORITY|||||||0.3826|||||||ANOVA|Interaction of intervention(MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), temporal control, and contextual control on reaction time||||||0.3826
71106288|NCT01334918|141719415|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Predefined noninferiority criterion: If the lower boundary of the 95% CI was within 0.15 of 0.78, MDCT would be determined to be noninferior to SPECT.|Agreement rate|0.87|STANDARD_ERROR_OF_MEAN|0.051|||TWO_SIDED|95.0|0.77|0.97||||||Analysis of agreement rate based on participants with 0 -1 and ≥ 2 reversible defects according to SPECT. Agreement is defined as the proportion of participants who had the same status from SPECT and MDCT, averaged across those with 2 or more reversible defects and those without, where SPECT is the reference standard.||0.97|0.77|
71106289|NCT01334918|141719420|SUPERIORITY_OR_OTHER_LEGACY||Specificity|0.95|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|95.0|0.9|0.99||||||Analysis of specificity based on participants with no fixed defects according to SPECT. Specificity is defined as a proportion of true negatives that are correctly identified, using SPECT as the reference standard.||0.99|0.90|
71106290|NCT01334918|141719420|SUPERIORITY_OR_OTHER_LEGACY||Sensitivity|0.77|STANDARD_ERROR_OF_MEAN|0.117|||TWO_SIDED|95.0|0.54|1.0||||||Analysis of sensitivity based on participants with ≥ 1 fixed defect according to SPECT. Sensitivity is the proportion of true positives that are correctly identified using SPECT as the reference standard.||1.00|0.54|
71106291|NCT01409096|141719470|SUPERIORITY_OR_OTHER|||||||0.9084|TWO_SIDED||||||ANCOVA|||Baseline HRSD scores used as covariate.||||0.9084
71106292|NCT01409096|141719471|SUPERIORITY_OR_OTHER|||||||0.5187|TWO_SIDED||||||ANCOVA|||Baseline IDS-SR used as a covariate.||||0.5187
71106293|NCT01409096|141719472|SUPERIORITY_OR_OTHER|||||||0.606|TWO_SIDED||||||ANOVA|||Baseline YMRS used as a covariate.||||0.6060
71106294|NCT01409096|141719473|SUPERIORITY_OR_OTHER|||||||0.511|TWO_SIDED||||||ANCOVA|||Baseline HRSA used as a covariate.||||0.5110
71106295|NCT00949533|141719488|SUPERIORITY_OR_OTHER|||||||0.825|||||||Pearson Chi-Square|||||||0.825
71106296|NCT00949533|141719489|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||> 0.05
71106297|NCT00949533|141719490|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||Cough: statistical difference between 2 groups was based on chi-squared test.||||1.000
71106298|NCT00949533|141719490|SUPERIORITY_OR_OTHER|||||||0.284|||||||Chi-squared|||Rhinorrhea: statistical difference between 2 groups was based on chi-squared test.||||0.284
71106299|NCT00949533|141719490|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Sore throat: statistical difference between 2 groups was based on fisher-exact test.||||1.000
71106300|NCT00949533|141719490|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Shortness of breath: statistical difference between 2 groups was based on fisher-exact test.||||1.000
71106301|NCT00949533|141719490|SUPERIORITY_OR_OTHER|||||||0.487|||||||Fisher Exact|||Diarrhea: statistical difference between 2 groups was based on fisher-exact test.||||0.487
71106302|NCT00949533|141719490|SUPERIORITY_OR_OTHER|||||||0.593|||||||Fisher Exact|||Headache: statistical difference between 2 groups was based on fisher-exact test.||||0.593
71106303|NCT00949533|141719490|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Conjunctivitis: statistical difference between 2 groups was based on fisher-exact test.||||1.000
71106304|NCT00949533|141719490|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Vomiting: statistical difference between 2 groups was based on fisher-exact test.||||1.000
71106305|NCT00949533|141719490|SUPERIORITY_OR_OTHER|||||||0.106|||||||Fisher Exact|||Other: statistical difference between 2 groups was based on fisher-exact test.||||0.106
71106306|NCT00557193|141719493|SUPERIORITY||Hazard Ratio (HR)|1.107||||0.672|ONE_SIDED|85.0||1.403||A priori significance level threshold of alpha=0.15|Log Rank||Arm C is the numerator and Arm B is the denominator of the estimated hazard ratio|A one-sided log rank test will be used for testing whether the EFS in Arm C (chemo+lest) at DL2 is greater than the EFS in Arm B (chemo). This is equivalent to testing the null hypothesis of hazard ratio (HR)=1 versus the alternative of HR\<1.||1.403||0.672
71106307|NCT00976456|141719506|NON_INFERIORITY_OR_EQUIVALENCE|The estimation was that in the pemetrexed-carboplatin plus bevacizumab Arm the median PFS will be 5.5 months. A median PFS of 4 months (5.5 - 27%) had been regarded non-inferior. Assuming the accrual period of 24 months and the whole study duration of 42 months, 246 patients had to be recruited. According to the fact, that the required statistical power of 80% will be reached by occurrence of altogether 227 events, the final analysis was done at this time point.|Hazard Ratio (HR)|1.29||||0.0583|TWO_SIDED|95.0|0.989|1.682|||Wilcoxon (Mann-Whitney)|||||1.682|0.989|0.0583
71106308|NCT00976456|141719507|NON_INFERIORITY_OR_EQUIVALENCE|The estimation was that in the pemetrexed-carboplatin plus bevacizumab Arm the median PFS will be 5.5 months. A median PFS of 4 months (5.5 - 27%) had been regarded non-inferior. Assuming the accrual period of 24 months and the whole study duration of 42 months, 246 patients had to be recruited. According to the fact, that the required statistical power of 80% will be reached by occurrence of altogether 227 events, the final analysis was done at this time Point.|Hazard Ratio (HR)|1.091||||0.3869|TWO_SIDED|95.0|0.794|1.499|||Wilcoxon (Mann-Whitney)|||||1.499|0.794|0.3869
71106309|NCT02037529|141719510|SUPERIORITY|||||||0.5623|||||||Log Rank|||||||0.5623
71106310|NCT02037529|141719515|SUPERIORITY|||||||0.984|||||||Log Rank|||||||0.9840
70932450|NCT02307682|141364359|OTHER||Difference in proportions|-12.5|||||TWO_SIDED|95.0|-19.8|-5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-5.6|-19.8|
71053085|NCT01781481|141610508|SUPERIORITY_OR_OTHER||R2Change|0.05|||<|0.01|TWO_SIDED|||||Threshold for statistical significance is p\<0.01|Regression, Linear|||A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of calls to the IBD Nurse. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.||||<0.01
71053086|NCT01781481|141610509|SUPERIORITY_OR_OTHER||Rsquare change statistic|0.05|||<|0.01|TWO_SIDED|||||p\<.05 threshold for statistical significance|Regression, Linear|Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.||A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of extra appointments with the IBD team. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3).||||<0.01
71053087|NCT01781481|141610510|SUPERIORITY_OR_OTHER||R2Change|0.03|||<|0.05|TWO_SIDED|||||Threshold for statistical significance is p \<0.05.|Regression, Linear|||A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of ER Visits. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.||||<0.05
71053088|NCT01781481|141610511|SUPERIORITY_OR_OTHER||R2Change|0.07|||<|0.01|TWO_SIDED||||||Regression, Linear|||A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of hospital services involved in child's care. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.||||<0.01
71053089|NCT04086407|141610512|OTHER||||||<|0.05|||||||t-test, 2 sided||||All statistical tests were completed with a significance of p \< 0.05 and 95% confidence intervals. Sample sets were statistically compared and analyzed by using two-tailed, unpaired Student t test analyses of means.|||<.05
71053090|NCT04086407|141610513|OTHER||||||<|0.05|||||||t-test, 2 sided||||All statistical tests were completed with a significance of p \< 0.05 and 95% confidence intervals. Sample sets were statistically compared and analyzed by using two-tailed, unpaired Student t test analyses of means.|||<.05
71053091|NCT04086407|141610514|OTHER||||||||||||||||||All statistical tests were completed with a significance of p \< 0.05 and 95% confidence intervals. Sample sets were statistically compared and analyzed by using two-tailed, unpaired Student t test analyses of means.|||
71053092|NCT04086407|141610515|OTHER||||||<|0.05|||||||t-test, 2 sided||||All statistical tests were completed with a significance of p \< 0.05 and 95% confidence intervals. Sample sets were statistically compared and analyzed by using two-tailed, unpaired Student t test analyses of means.|||<.05
71053093|NCT02684630|141610516|OTHER|A procedure is a success if the donor's post-procedure platelet count is ≥ 100,000 platelets/μL, lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple sample proportion|1.0|STANDARD_DEVIATION|0.0|||ONE_SIDED|95.0|0.951||||||Estimated proportion is 100%. Hence standard deviation is estimated as 0.|"Sample Size Determination:~Up to 160 participants were to be enrolled in this study to ensure 60 evaluable single platelet product collections and 60 evaluable double platelet product collections. This number was chosen to meet the FDA requirements of 95% of postprocedure participant platelet count of ≥ 100,000 platelets/μL with 95% confidence."|||0.951|
71053094|NCT02684630|141610517|OTHER|A procedure is a success if the donor's post-procedure platelet count is ≥ 100,000 platelets/μL, lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple sample proportion|1.0|STANDARD_DEVIATION|0.0|||ONE_SIDED|95.0|0.951||||||Estimated proportion is 100%. Hence standard deviation is estimated as 0.|"Sample Size Determination:~Up to 160 participants were to be enrolled in this study to ensure 60 evaluable single platelet product collections and 60 evaluable double platelet product collections. This number was chosen to meet the FDA requirements of 95% of postprocedure participant platelet count of ≥ 100,000 platelets/μL with 95% confidence."|||0.951|
71053095|NCT02885181|141610552|SUPERIORITY||Least Squares (LS) Means of Differences|0.01||||0.978|TWO_SIDED|95.0||0.76|||Cochran-Mantel-Haenszel|||||0.76|- 0.74|0.978
71053096|NCT02885181|141610552|SUPERIORITY||LS Means of Differences|0.4||||0.3|TWO_SIDED|95.0||1.16|||Cochran-Mantel-Haenszel|||||1.16|- 0.36|0.300
71053097|NCT02885181|141610552|SUPERIORITY||LS Means of Differences|0.0||||0.002|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||- 0.43|- 1.92|0.002
71053098|NCT02885181|141610553|SUPERIORITY||Difference in Response Rates|-5.9||||0.66|TWO_SIDED|95.0|-36.0|24.0|||Cochran-Mantel-Haenszel|||||24.0|-36.0|0.660
71053099|NCT02885181|141610553|SUPERIORITY||Difference in Response Rates|-15.9||||0.277|TWO_SIDED|95.0|-44.7|13.8|||Cochran-Mantel-Haenszel|||||13.8|-44.7|0.277
71053100|NCT02885181|141610553|SUPERIORITY||Difference in Response Rates|40.0||||0.009|TWO_SIDED|95.0|10.7|65.6|||Cochran-Mantel-Haenszel|||||65.6|10.7|0.009
71053101|NCT02885181|141610554|SUPERIORITY||Difference in Response Rates|-2.7||||0.853|TWO_SIDED|95.0|-32.0|27.5|||Cochran-Mantel-Haenszel|||||27.5|-32.0|0.853
71053102|NCT02885181|141610554|SUPERIORITY||Difference in Response Rates|-2.7||||0.852|TWO_SIDED|95.0|-32.0|27.5|||Cochran-Mantel-Haenszel|||||27.5|-32.0|0.852
71053103|NCT02885181|141610554|SUPERIORITY||Difference in Response Rates|24.9||||0.092|TWO_SIDED|95.0|-6.6|51.5|||Cochran-Mantel-Haenszel|||||51.5|-6.6|0.092
71053104|NCT02885181|141610555|SUPERIORITY||Difference in Response Rates|-8.6||||0.36|TWO_SIDED|95.0|-37.9|22.5|||Cochran-Mantel-Haenszel|||||22.5|-37.9|0.360
71053105|NCT02885181|141610555|SUPERIORITY||Difference in Response Rates|1.4||||0.896|TWO_SIDED|95.0|-28.0|31.7|||Cochran-Mantel-Haenszel|||||31.7|-28.0|0.896
71053106|NCT02885181|141610555|SUPERIORITY||Difference in Response Rates|24.5||||0.072|TWO_SIDED|95.0|-6.6|50.1|||Cochran-Mantel-Haenszel|||||50.1|-6.6|0.072
70932451|NCT02307682|141364359|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-5.9|7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||7.2|-5.9|
70932452|NCT02307682|141364359|OTHER||Difference in proportions|-3.4|||||TWO_SIDED|95.0|-9.8|2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||2.6|-9.8|
70932453|NCT02307682|141364359|OTHER||Difference in proportions|-4.4|||||TWO_SIDED|95.0|-11.2|2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||2.5|-11.2|
70932454|NCT02307682|141364359|OTHER||Difference in proportions|-8.1|||||TWO_SIDED|95.0|-15.3|-1.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||-1.0|-15.3|
70932455|NCT02307682|141364359|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-8.9|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.6|-8.9|
70932456|NCT02307682|141364359|OTHER||Difference in proportions|-4.5|||||TWO_SIDED|95.0|-11.2|1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||1.7|-11.2|
70932457|NCT02307682|141364359|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-10.8|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.7|-10.8|
70932458|NCT02307682|141364359|OTHER||Difference in proportions|-10.3|||||TWO_SIDED|95.0|-17.3|-3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||-3.5|-17.3|
70932459|NCT02307682|141364359|OTHER||Difference in proportions|4.1|||||TWO_SIDED|95.0|-2.3|11.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||11.0|-2.3|
70932460|NCT02307682|141364359|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-9.8|2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||2.6|-9.8|
70932461|NCT02307682|141364359|OTHER||Difference in proportions|-6.4|||||TWO_SIDED|95.0|-13.2|0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||0.7|-13.2|
70932462|NCT02307682|141364359|OTHER||Difference in proportions|-12.9|||||TWO_SIDED|95.0|-19.7|-6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||-6.6|-19.7|
70932463|NCT02307682|141364360|SUPERIORITY|||||||0.0574||||||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|Cochran-Mantel-Haenszel|CMH-test row mean score (scores=table) stratified by age categories (\<75, ≥75 years) and baseline fluid status)||||||0.0574
70932464|NCT02307682|141364360|SUPERIORITY|||||||0.0012||||||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|Cochran-Mantel-Haenszel|CMH-test row mean score (scores=table) stratified by age categories (\<75, ≥75 years) and baseline fluid status)||||||0.0012
70932465|NCT02307682|141364361|SUPERIORITY||difference in proportions|-6.5||||0.0331|TWO_SIDED|95.0|-13.2|0.3||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for age categories (\<75, \>=75 years) and treatment as fixed effect factors. 95% CI for the treatment difference estimated using bootstrap method.|||0.3|-13.2|0.0331
70932466|NCT02307682|141364361|SUPERIORITY||difference in proportions|-10.5||||0.0013|TWO_SIDED|95.0|-17.1|-3.5||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for age categories (\<75, \>=75 years) and treatment as fixed effect factors. 95% CI for the treatment difference estimated using bootstrap method.|||-3.5|-17.1|0.0013
71053107|NCT02885181|141610556|SUPERIORITY||LS Means of Differences|-0.12||||0.528|TWO_SIDED|95.0|-0.49|0.25|||Cochran-Mantel-Haenszel|||||0.25|-0.49|0.528
71053108|NCT02885181|141610556|SUPERIORITY||LS Means of Differences|0.2||||0.293|TWO_SIDED|95.0|-0.17|0.57|||Cochran-Mantel-Haenszel|||||0.57|-0.17|0.293
71053109|NCT02885181|141610556|SUPERIORITY||LS Means of Differences|-0.33||||0.072|TWO_SIDED|95.0|-0.7|0.03|||Cochran-Mantel-Haenszel|||||0.03|-0.70|0.072
71053110|NCT00123474|141610573|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the QD schedule relative to the BID schedule was deduced if the lower bound of the 95% confidence interval (CI) for the MCyRRQD minus MCyRRBID difference was greater than or equal to -15%.|Risk Difference (RD)|2.8|||||TWO_SIDED|95.0|-6.0|11.6||||||6 Month Analysis||11.6|-6.0|
71106311|NCT02037529|141719516|SUPERIORITY|||||||0.5968|||||||Log Rank|||||||0.5968
71020487|NCT01029769|141548095|OTHER|"a logistic regression model with remission as the dependent variable and switch of treatment (yes/no) and PANSS-total score at visit 3 as independent variables was used. Multiple imputation (based upon 20 imputations, primary analysis), last observation carried forward and completers only analyses were performed."|||||=|0.01||||||Multiple imputation was performed separately for the switch and non-switch arms and the imputation model included the PANSS total score from all visits from phase II baseline (visit 2) onwards, remission at visit 7 and phase I arm allocation|Regression, Logistic|||Irrespective of the initially assigned antipsychotic treatment in period 1 of the trial (2-week-phase), the patients showing little improvement over the two weeks of treatment in period 1 now switched from the initial treatment in period 2 of the trial (6-week-phase) were grouped together as well as the patients non-switched from their initial treatment.||||=0.01
71020488|NCT00709735|141548098|SUPERIORITY||Mean Difference (Final Values)|-13.0|||||TWO_SIDED|95.0|-30.0|4.0|||||Non-Reactivation Propranolol (NRP) - Reactivation Propranolol (RP)|||4.0|-30.0|
71020489|NCT00709735|141548099|SUPERIORITY||Mean Difference (Final Values)|-12.7|||||TWO_SIDED|95.0|-27.4|1.9|||||Non-Reactivation Propranolol (NRP) - Reactivation Propranolol (RP)|||1.9|-27.4|
70932467|NCT02307682|141364362|OTHER|Treatment difference|Least squares mean difference|0.9|||||TWO_SIDED|95.0|-0.5|2.3||Hypothesis testing not pre-specified|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 24||2.3|-0.5|
70932468|NCT02307682|141364362|OTHER|Treatment difference|Least squares mean difference|0.63|||||TWO_SIDED|95.0|-0.9|2.1||Hypothesis testing not pre-specified|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||2.1|-0.9|
71020490|NCT00666718|141548100|NON_INFERIORITY_OR_EQUIVALENCE|"Assuming a drop-out rate after randomization of approximately 15%, the remaining 160 patients in each treatment group should allow confirmation of noninferiority with no true treatment difference and a noninferiority limit of 0.4% using the upper limit of a 2-sided 95% confidence interval (insulin lispro protamine suspension + insulin lispro minus insulin glargine+insulin lispro) at a significance level of 0.025 with 90% power."|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.11|0.31|||ANCOVA|||||0.31|-0.11|
71020491|NCT00666718|141548101|SUPERIORITY_OR_OTHER|||||||0.458||95.0||||p-value is for Week 12 Change.|Mixed Models Analysis|Change from baseline=Treatment+country+baseline HbA1c+week+treatment\*country+treatment\*week+baseline HbA1c\*treatment (unstructured covariance used).||||||0.4580
71053111|NCT00123474|141610574|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the QD schedule relative to the BID schedule was deduced if the lower bound of the 95% CI for the MCyRRQD minus MCyRRBID difference was greater than or equal to -15%.|Risk Difference (RD)|1.9|||||TWO_SIDED|95.0|-6.8|10.6||||||||10.6|-6.8|
71053112|NCT00123474|141610574|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of 100 mg total daily dose relative to 140 mg total daily dose was deduced if the lower bound of the 95% CI for the difference was greater than or equal to -15%.|Risk Difference (RD)|-0.2|||||TWO_SIDED|95.0|-8.9|8.5||||||||8.5|-8.9|
71020492|NCT00666718|141548101|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||p-value is for Week 24 Change.|Mixed Models Analysis|Change from baseline=Treatment+country+baseline HbA1c+week+treatment\*country+treatment\*week+baseline HbA1c\*treatment (unstructured covariance used).||||||0.1070
71020493|NCT00666718|141548102|SUPERIORITY_OR_OTHER|||||||0.1333||95.0||||p-value is for HbA1c \<7.0%.|Fisher Exact|||||||0.1333
71020494|NCT00666718|141548102|SUPERIORITY_OR_OTHER|||||||0.1213||95.0||||p-value is for HbA1c \<=6.5%|Fisher Exact|||||||0.1213
71020495|NCT00666718|141548103|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37|||||TWO_SIDED|95.0|-0.43|1.17|||Mixed Models Analysis|Morning Pre-Meal measurement = Treatment+country+week+treatment\*country + treatment\*week (unstructured covariance was used)||||1.17|-0.43|
71020496|NCT00666718|141548103|SUPERIORITY_OR_OTHER||LS Mean Difference|0.26|||||TWO_SIDED|95.0|-0.66|1.19|||Mixed Models Analysis|Morning Postprandial measurement = Treatment +country+week+treatment\*country + treatment\*week (unstructured covariance was used)||||1.19|-0.66|
71020497|NCT00666718|141548103|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|||||TWO_SIDED|95.0|-1.15|0.57|||Mixed Models Analysis|Midday Pre-Meal measurement = Treatment +country + week +treatment\*country + treatment\*week (unstructured covariance was used).||||0.57|-1.15|
71053113|NCT00123474|141610585|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the QD schedule relative to the BID schedule was deduced if the lower bound of the 95% CI for the MCyRRQD minus MCyRRBID difference was greater than or equal to -15%.|Risk Difference (RD)|1.8|||||TWO_SIDED|95.0|-11.7|15.3||||||6 Month Analysis||15.3|-11.7|
71053114|NCT00123474|141610585|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of 100 mg QD Total Daily Dose relative to 140 mg QD Total Daily Dose was deduced if the lower bound of the 95% CI difference was greater than or equal to -15%.|Risk Difference (RD)|4.2|||||TWO_SIDED|95.0|-9.3|17.6||||||6 Month Analysis||17.6|-9.3|
71053115|NCT00123474|141610585|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the QD schedule relative to the BID schedule was deduced if the lower bound of the 95% CI for the MCyRRQD minus MCyRRBID difference was greater than or equal to -15%.|Risk Difference (RD)|1.4|||||TWO_SIDED|95.0|-11.2|14.1||||||24 Month Analysis||14.1|-11.2|
70932469|NCT02307682|141364362|OTHER|Treatment difference|Least squares mean difference|-0.2|||||TWO_SIDED|95.0|-1.8|1.4||Hypothesis testing not pre-specified.|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 48||1.4|-1.8|
70932470|NCT02307682|141364362|OTHER|Treatment difference|Least squares mean difference|-0.26|||||TWO_SIDED|95.0|-1.9|1.4||Hypothesis testing not pre-specified.|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||1.4|-1.9|
71020498|NCT00666718|141548103|SUPERIORITY_OR_OTHER||LS Mean Difference|0.47|||||TWO_SIDED|95.0|-0.46|1.4|||Mixed Models Analysis|Midday Postprandial measurement = Treatment+country+week+treatment\*country + treatment\*week (unstructured covariance was used).||||1.40|-0.46|
71020499|NCT00666718|141548103|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05|||||TWO_SIDED|95.0|-0.93|0.83|||Mixed Models Analysis|Evening Pre-Meal measurement = Treatment +country+week+treatment\*country + treatment\*week (unstructured covariance was used).||||0.83|-0.93|
71053116|NCT00123474|141610585|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of 100 mg QD Total Daily Dose relative to 140 mg QD Total Daily Dose was deduced if the lower bound of the 95% CI difference was greater than or equal to -15%.|Risk Difference (RD)|1.4|||||TWO_SIDED|95.0|-11.2|14.1||||||24 Month Analysis||14.1|-11.2|
71053117|NCT01059344|141610595|SUPERIORITY_OR_OTHER|||||||0.069|||||||Chi-squared|||||||0.069
71053118|NCT01059344|141610596|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71053119|NCT01059344|141610597|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71053120|NCT01059344|141610598|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.010
71053121|NCT01059344|141610599|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71020500|NCT00666718|141548103|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46|||||TWO_SIDED|95.0|-0.41|1.34|||Mixed Models Analysis|Evening Postprandial measurement = Treatment+country+week +treatment\*country + treatment\*week (unstructured covariance was used).||||1.34|-0.41|
71020501|NCT00666718|141548103|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14|||||TWO_SIDED|95.0|-0.67|0.96|||Mixed Models Analysis|0300 Hours measurement = Treatment+country+week+treatment\*country+treatment\*week (unstructured covariance was used).||||0.96|-0.67|
71020502|NCT00666718|141548104|SUPERIORITY_OR_OTHER|||||||0.5568||95.0||||p-value is for Fasting.|ANCOVA|Glycemic variability = Treatment+country grouping (Mediterranean, rest of Europe)+treatment\*country (Mediterranean, rest of Europe)||||||0.5568
71020503|NCT00666718|141548104|SUPERIORITY_OR_OTHER|||||||0.7523||95.0||||p-value is for Post-breakfast.|ANCOVA|Glycemic variability = Treatment+country grouping (Mediterranean, rest of Europe)+treatment\*country (Mediterranean, rest of Europe)||||||0.7523
71020504|NCT00666718|141548104|SUPERIORITY_OR_OTHER|||||||0.6448||95.0||||p-value is for Post-lunch.|ANCOVA|Glycemic variability = Treatment+country grouping (Mediterranean, rest of Europe)+treatment\*country (Mediterranean, rest of Europe)||||||0.6448
71020505|NCT00666718|141548104|SUPERIORITY_OR_OTHER|||||||0.9122||95.0||||p-value is for Post-dinner.|ANCOVA|Glycemic variability = Treatment+country grouping (Mediterranean, rest of Europe)+ treatment\*country (Mediterranean, rest of Europe)||||||0.9122
71020506|NCT00666718|141548105|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.53|||||TWO_SIDED|95.0|-1.19|0.12|||Mixed Models Analysis|Hypoglycemia rate per 30 days = Treatment+Country+Week+Treatment\*Country+Treatment\*Week (unstructured covariance structure was used)||||0.12|-1.19|
71020507|NCT00666718|141548105|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|||||TWO_SIDED|95.0|-0.2|0.11|||Mixed Models Analysis|Hypoglycemia rate per 30 days = Treatment+Country+Week+Treatment\*Country+Treatment\*Week (unstructured covariance structure was used)||||0.11|-0.20|
71020508|NCT00666718|141548105|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.45|||||TWO_SIDED|95.0|-1.06|0.16|||Mixed Models Analysis|Hypoglycemia rate per 30 days = Treatment+Country+Week+Treatment\*Country+Treatment\*Week (unstructured covariance structure was used)||||0.16|-1.06|
71020509|NCT00666718|141548105|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|||||TWO_SIDED|95.0|-0.86|0.06|||Mixed Models Analysis|Hypoglycemia rate per 30 days = Treatment+Country+Week+Treatment\*Country+Treatment\*Week (unstructured covariance structure was used)||||0.06|-0.86|
71020510|NCT00666718|141548105|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.14|0.12|||Mixed Models Analysis|Hypoglycemia rate per 30 days=Treatment+Country+Week+Treatment\*Country+Treatment\*Week (unstructured covariance structure was used)||||0.12|-0.14|
71020511|NCT00666718|141548106|SUPERIORITY_OR_OTHER|||||||0.1701||95.0||||p-value is for \>=1 hypoglycemic episode.|Fisher Exact|||||||0.1701
71020512|NCT00666718|141548106|SUPERIORITY_OR_OTHER|||||||0.1727||95.0||||p-value is for \>=1 nocturnal hypoglycemic episode.|Fisher Exact|||||||0.1727
71053122|NCT01059344|141610600|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71053123|NCT01059344|141610601|SUPERIORITY|||||||0.011|||||||Chi-squared|||||||0.011
71053124|NCT04420273|141610673|OTHER||||||<|0.001|||||||McNemar|McNemar's chi-square with continuity correction||1-month survey||||<0.001
71053125|NCT04420273|141610673|OTHER||||||<|0.001|||||||McNemar|McNemar's chi-square with continuity correction||2- months||||<0.001
71053126|NCT04420273|141610673|OTHER||||||<|0.001|||||||McNemar|McNemar's chi-square with continuity correction||3-months||||<0.001
71053127|NCT04420273|141610674|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
71053128|NCT04420273|141610675|OTHER||||||<|0.1|||||||Chi-squared|||||||< 0.1
71053129|NCT04420273|141610676|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
71053130|NCT04420273|141610677|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
71053131|NCT04420273|141610678|OTHER|||||||0.459|||||||Chi-squared|||||||0.459
71053132|NCT04420273|141610678|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71053133|NCT04420273|141610679|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
71053134|NCT02994940|141610691|SUPERIORITY||Hodges Lehman estimator|21.3||||0.127|TWO_SIDED|95.0|-2.5|44.2|||Wilcoxon (Mann-Whitney)|||||44.2|-2.5|0.127
71053135|NCT02994940|141610692|SUPERIORITY|||||||0.851|||||||Chi-squared|||||||0.851
71053136|NCT02994940|141610693|SUPERIORITY||Hodges Lehman estimator|2.0||||0.109|TWO_SIDED|95.0|-1.0|6.0|||Wilcoxon (Mann-Whitney)|||||6.0|-1.0|0.109
71053137|NCT02994940|141610694|SUPERIORITY||Hodges Lehman estimator|7.0||||0.0001|TWO_SIDED|95.0|4.0|8.0|||Wilcoxon (Mann-Whitney)|||||8.0|4.0|0.0001
71053138|NCT03233230|141610695|SUPERIORITY||Odds Ratio (OR)|1.48||||0.1746|TWO_SIDED|95.0|0.84|2.61|||Regression, Logistic|||||2.61|0.84|0.1746
71053139|NCT03233230|141610695|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8283|TWO_SIDED|95.0|0.61|1.87|||Regression, Logistic|||||1.87|0.61|0.8283
71020513|NCT00666718|141548106|SUPERIORITY_OR_OTHER|||||||0.2094||95.0||||p-value is for \>=1 non-nocturnal hypoglycemic episode.|Fisher Exact|||||||0.2094
71020514|NCT00666718|141548106|SUPERIORITY_OR_OTHER|||||||0.623||95.0||||p-value is for \>=1 severe hypoglycemic episode.|Fisher Exact|||||||0.6230
71020515|NCT00666718|141548108|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.16|||||TWO_SIDED|95.0|-0.86|0.55|||ANCOVA|weight change from baseline = Treatment + country + baseline Hb1Ac + baseline weight + treatment\*HbA1c baseline value||||0.55|-0.86|
71020516|NCT00666718|141548109|SUPERIORITY_OR_OTHER||LS Mean Difference|2.18|||||TWO_SIDED|95.0|-8.33|12.68|||Mixed Models Analysis|Total daily insulin dose=Treatment+country+week+treatment\*country+ treatment\*week (unstructured covariance was used).||||12.68|-8.33|
71020517|NCT00810615|141548127|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANCOVA|A repeated measures model was designed so as to incorporate the adjust for the repeated (dependent) measures within individuals over time.||ANCOVA, baseline measurement was considered as a covariate and group (sham or 2.4 ATA), treatment (15 treatments, 30 treatments, and 6 weeks) as well as the interaction between group and treatment were considered as the independent variables.||||0.05
71020518|NCT00810615|141548139|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5455||||||||||||||Relative Risk of Improvement in 2.4 ATA group vs. Sham in subjects with one significant event (blast or impact resulting in concussion symptoms) per Concussion History. PCL-M with significant improvement defined as a score decrease 10 or more.||||
71020519|NCT00810615|141548140|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||||||||||||Relative Risk of Improvement in 2.4 ATA group vs. Sham in subjects with two significant events (blast or impact resulting in concussion symptoms) per Concussion History. PCL-M with significant improvement defined as a score decrease 10 or more.||||
71020520|NCT00810615|141548141|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1111||||||||||||||Relative Risk of Improvement in 2.4 ATA group vs. Sham in subjects with three significant events (blast or impact resulting in concussion symptoms) per Concussion History. PCL-M with significant improvement defined as a score decrease 10 or more.||||
71020521|NCT00810615|141548142|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||||||||||||Relative Risk of Improvement in 2.4 ATA group vs. Sham in subjects with four or more significant events (blast or impact resulting in concussion symptoms) per Concussion History. PCL-M with significant improvement defined as a score decrease 10 or more.||||
71020522|NCT02567266|141548149|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.338|TWO_SIDED|95.0|-0.58|0.2||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-I at Post-Treatment||.20|-.58|.338
71020523|NCT02567266|141548149|SUPERIORITY||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.2||0.425|TWO_SIDED|95.0|-0.24|0.57||Threshold: p \<.05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-I at Post Treatment||0.57|-0.24|0.425
71020524|NCT02567266|141548149|SUPERIORITY||Mean Difference (Net)|-0.36|STANDARD_ERROR_OF_MEAN|0.21||0.09|TWO_SIDED|95.0|-0.77|0.06||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-I at Post||0.06|-0.77|0.09
71020525|NCT02567266|141548149|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.2||0.126|TWO_SIDED|95.0|-0.72|0.09||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-I at Follow-Up||0.09|-0.72|0.126
71020526|NCT02567266|141548149|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.21||0.28|TWO_SIDED|95.0|-0.65|0.19||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-I at Follow-Up||0.19|-0.65|0.28
71020527|NCT02567266|141548149|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.21||0.697|TWO_SIDED|95.0|-0.51|0.34||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-I at Follow-Up||0.34|-0.51|0.697
71020528|NCT02567266|141548150|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.26||0.779|TWO_SIDED|95.0|-0.6|0.45||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-S at Follow-Up||0.45|-0.6|0.779
71020529|NCT02567266|141548150|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.27||0.66|TWO_SIDED|95.0|-0.42|0.67||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-S at Follow-Up||0.67|-0.42|0.66
71020530|NCT02567266|141548150|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.629|TWO_SIDED|95.0|-0.51|0.31||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-S at Post||0.31|-0.51|0.629
71020531|NCT02567266|141548150|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.2||0.938|TWO_SIDED|95.0|-0.41|0.38||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-S at Post||0.38|-0.41|0.938
71020532|NCT02567266|141548150|SUPERIORITY||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.21||0.68|TWO_SIDED|95.0|-0.32|0.49||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-S at Post||0.49|-0.32|0.68
71020533|NCT02567266|141548150|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.479|TWO_SIDED|95.0|-0.75|0.35||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-S at Follow-Up||0.35|-0.75|0.479
71020534|NCT02567266|141548151|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|1.58||0.852|TWO_SIDED|95.0|-2.85|3.45||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGAS at Post||3.45|-2.85|0.852
71020535|NCT02567266|141548151|SUPERIORITY||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|1.62||0.917|TWO_SIDED|95.0|-3.41|3.07||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGAS at Post||3.07|-3.41|0.917
71020536|NCT02567266|141548151|SUPERIORITY||Mean Difference (Net)|0.47|STANDARD_ERROR_OF_MEAN|1.66||0.778|TWO_SIDED|95.0|-2.81|3.74||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGAS at Post||3.74|-2.81|0.778
71020537|NCT02567266|141548151|SUPERIORITY||Mean Difference (Net)|0.95|STANDARD_ERROR_OF_MEAN|2.12||0.66|TWO_SIDED|95.0|-3.3|5.19||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGAS at Follow-Up||5.19|-3.3|0.66
71020538|NCT02567266|141548151|SUPERIORITY||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|2.19||0.935|TWO_SIDED|95.0|-4.55|4.19||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGAS at Follow-Up||4.19|-4.55|0.935
71020539|NCT02567266|141548151|SUPERIORITY||Mean Difference (Net)|1.13|STANDARD_ERROR_OF_MEAN|2.21||0.615|TWO_SIDED|95.0|-3.29|5.55||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGAS at Follow-Up||5.55|-3.29|0.615
71020540|NCT02643966|141548152|OTHER|We compared DBT cancer yield per 1,000 for first observer (usual care) vs DBT and WBUS cancer yield per 1,000 for first observer for Year/Screen 1.|simple proportions|1.3||||0.005|TWO_SIDED|95.0|0.3|2.1||The threshold for statistical significance was p = 0.05|nonparametric bootstrap approach|The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units||The primary unit of analysis was the screening examination. A sample size of 16,700 screens (6,200 women, estimating 8%-10% loss to follow-up each year) was expected to provide 82% power to identify an added cancer detection rate (CDR) from US of 1.1/1,000. Screens were included for analysis if the patient was diagnosed with breast cancer or at least 10.5-month imaging or clinical follow-up (ie, at end of study participation) showed no evidence of breast cancer.||2.1|0.3|0.005
71020541|NCT02643966|141548152|OTHER|We compared DBT cancer yield per 1,000 for first observer (usual care) vs DBT and WBUS cancer yield per 1,000 for first observer for Years/Screens 2 \& 3.|simple proportions|1.0|||<|0.001|TWO_SIDED|95.0|0.4|1.5||The threshold for statistical significance was p = 0.05|nonparametric bootstrap approach|The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units||The primary unit of analysis was the screening examination. A sample size of 16,700 screens (6,200 women, estimating 8%-10% loss to follow-up each year) was expected to provide 82% power to identify an added cancer detection rate (CDR) from US of 1.1/1,000. Screens were included for analysis if the patient was diagnosed with breast cancer or at least 10.5-month imaging or clinical follow-up (ie, at end of study participation) showed no evidence of breast cancer.||1.5|0.4|<0.001
71020542|NCT02643966|141548153|OTHER|We compared DBT true positive findings for first observer (usual care) vs DBT and WBUS true positive findings for first observer for Year/Screen 1.|simple proportions|17.8||||0.005|TWO_SIDED|95.0|4.4|31.1||The threshold for statistical significance was p = 0.05|nonparametric bootstrap approach|The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units||The primary unit of analysis was the screening examination. A sample size of 16,700 screens (6,200 women, estimating 8%-10% loss to follow-up each year) was expected to provide 82% power to identify an added cancer detection rate (CDR) from US of 1.1/1,000. Screens were included for analysis if the patient was diagnosed with breast cancer or at least 10.5-month imaging or clinical follow-up (ie, at end of study participation) showed no evidence of breast cancer.||31.1|4.4|0.005
71020543|NCT02643966|141548153|OTHER|We compared DBT true positive findings for first observer (usual care) vs DBT and WBUS true positive findings for first observer for Years/Screens 2 and 3.|simple proportions|13.5|||<|0.001|TWO_SIDED|95.0|4.9|22.3||The threshold for statistical significance was p = 0.05|nonparametric bootstrap approach|The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units||The primary unit of analysis was the screening examination. A sample size of 16,700 screens (6,200 women, estimating 8%-10% loss to follow-up each year) was expected to provide 82% power to identify an added CDR from US of 1.1/1,000.Screens were included for analysis if the patient was diagnosed with breast cancer or at least 10.5-month imaging or clinical follow-up (ie, at end of study participation) showed no evidence of breast cancer.||22.3|4.9|< 0.001
71020544|NCT02643966|141548155|OTHER|We compared DBT false positive findings for first observer (usual care) vs DBT and WBUS false positive findings for first observer for Year/Screen 1.|Slope|4.5|||<|0.001|TWO_SIDED|95.0|3.8|5.1||The threshold for statistical significance was p = 0.05|nonparametric bootstrap approach|The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units||||5.1|3.8|< 0.001
71020545|NCT02643966|141548155|OTHER|We compared DBT false positive findings for first observer (usual care) vs DBT and WBUS false positive findings for first observer for Years/Screens 2 \& 3.|simple proportions|3.7|||<|0.001|TWO_SIDED|95.0|3.3|4.1||The threshold for statistical significance was p = 0.05|nonparametric bootstrap approach|The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units||||4.1|3.3|< 0.001
71053140|NCT03233230|141610695|SUPERIORITY||Odds Ratio (OR)|1.55||||0.1298|TWO_SIDED|95.0|0.88|2.74|||Regression, Logistic|||||2.74|0.88|0.1298
71053141|NCT03233230|141610696|SUPERIORITY||Response rate difference|0.13||||0.0077|TWO_SIDED|95.0|0.04|0.23|||Cochran-Mantel-Haenszel|||||0.23|0.04|0.0077
71053142|NCT03233230|141610696|SUPERIORITY||Response rate difference|0.17||||0.0013|TWO_SIDED|95.0|0.07|0.27|||Cochran-Mantel-Haenszel|||||0.27|0.07|0.0013
71053143|NCT03233230|141610696|SUPERIORITY||Response rate difference|0.13||||0.008|TWO_SIDED|95.0|0.04|0.23|||Cochran-Mantel-Haenszel|||||0.23|0.04|0.0080
71053144|NCT03233230|141610697|SUPERIORITY||Response rate difference|0.09||||0.0056|TWO_SIDED|95.0|0.03|0.17|||Cochran-Mantel-Haenszel|||||0.17|0.03|0.0056
71053145|NCT03233230|141610697|SUPERIORITY||Response rate difference|0.09||||0.005|TWO_SIDED|95.0|0.03|0.17|||Cochran-Mantel-Haenszel|||||0.17|0.03|0.0050
71053146|NCT03233230|141610697|SUPERIORITY||Response rate difference|0.09||||0.0053|TWO_SIDED|95.0|0.03|0.17|||Cochran-Mantel-Haenszel|||||0.17|0.03|0.0053
71053147|NCT03233230|141610698|SUPERIORITY||Response rate difference|0.09||||0.1419|TWO_SIDED|95.0|-0.03|0.21|||Cochran-Mantel-Haenszel|||||0.21|-0.03|0.1419
71020546|NCT03611751|141548209|SUPERIORITY||Odds Ratio (OR)|10.55|||<|0.0001|TWO_SIDED|95.0|6.54|17.0|||Cochran-Mantel-Haenszel|||||17.00|6.54|<0.0001
71020547|NCT03611751|141548210|SUPERIORITY||Odds Ratio (OR)|10.49|||<|0.0001|TWO_SIDED|95.0|6.65|16.55|||Cochran-Mantel-Haenszel|||||16.55|6.65|<0.0001
71020548|NCT03611751|141548211|SUPERIORITY||Odds Ratio (OR)|11.42|||<|0.0001|TWO_SIDED|95.0|5.45|23.93|||Cochran-Mantel-Haenszel|||||23.93|5.45|<0.0001
71020549|NCT03611751|141548211|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0046|TWO_SIDED|95.0|1.18|2.56|||Cochran-Mantel-Haenszel|||||2.56|1.18|0.0046
71020550|NCT03611751|141548212|SUPERIORITY||Odds Ratio (OR)|9.21|||<|0.001|TWO_SIDED|95.0|2.89|29.4|||Cochran-Mantel-Haenszel|||||29.40|2.89|<0.001
71020551|NCT03611751|141548212|SUPERIORITY||Odds Ratio (OR)|2.55||||0.0051|TWO_SIDED|95.0|1.3|5.0|||Cochran-Mantel-Haenszel|||||5.00|1.30|0.0051
71020552|NCT03611751|141548213|SUPERIORITY||Odds Ratio (OR)|14.44|||<|0.0001|TWO_SIDED|95.0|4.62|45.11|||Cochran-Mantel-Haenszel|||||45.11|4.62|<0.0001
70851323|NCT00669409|141190545|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-23.3|9.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.9|-23.3|
70851324|NCT00669409|141190545|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|5.1|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-11.5|21.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||21.7|-11.5|
70851325|NCT00669409|141190545|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|8.31|||TWO_SIDED|95.0|-24.1|8.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.8|-24.1|
71020553|NCT03611751|141548213|SUPERIORITY||Odds Ratio (OR)|2.85||||0.0002|TWO_SIDED|95.0|1.61|5.03|||Cochran-Mantel-Haenszel|||||5.03|1.61|0.0002
71020554|NCT03611751|141548214|SUPERIORITY||Mean Difference (Net)|-23.6|STANDARD_ERROR_OF_MEAN|1.67|<|0.0001|TWO_SIDED|95.0|-26.9|-20.3|||ANCOVA|||||-20.3|-26.9|<0.0001
71020555|NCT03611751|141548214|SUPERIORITY||Mean Difference (Net)|-7.2|STANDARD_ERROR_OF_MEAN|1.68|<|0.0001|TWO_SIDED|95.0|-10.5|-3.9|||ANCOVA|||||-3.9|-10.5|<0.0001
71020556|NCT03611751|141548215|SUPERIORITY||Odds Ratio (OR)|6.4||||0.0005|TWO_SIDED|95.0|1.94|21.15|||Cochran-Mantel-Haenszel|||||21.15|1.94|0.0005
71020557|NCT03611751|141548215|SUPERIORITY||Odds Ratio (OR)|1.82||||0.0928|TWO_SIDED|95.0|0.89|3.71|||Cochran-Mantel-Haenszel|||||3.71|0.89|0.0928
71020558|NCT03611751|141548216|SUPERIORITY||Odds Ratio (OR)|6.85|||<|0.0001|TWO_SIDED|95.0|4.34|10.81|||Cochran-Mantel-Haenszel|||||10.81|4.34|<0.0001
71020559|NCT03611751|141548216|SUPERIORITY||Odds Ratio (OR)|2.63|||<|0.0001|TWO_SIDED|95.0|1.77|3.91|||Cochran-Mantel-Haenszel|||||3.91|1.77|<0.0001
71020560|NCT03611751|141548217|SUPERIORITY||Odds Ratio (OR)|5.38|||<|0.0001|TWO_SIDED|95.0|3.42|8.47|||Cochran-Mantel-Haenszel|||||8.47|3.42|<0.0001
71020561|NCT03611751|141548218|SUPERIORITY||Odds Ratio (OR)|3.21||||0.0621|TWO_SIDED|95.0|0.88|11.79|||Cochran-Mantel-Haenszel|||||11.79|0.88|0.0621
71020562|NCT03611751|141548219|SUPERIORITY||Odds Ratio (OR)|0.64||||0.6692|TWO_SIDED|95.0|0.06|7.46|||Cochran-Mantel-Haenszel|||||7.46|0.06|0.6692
71020563|NCT03611751|141548219|SUPERIORITY||Odds Ratio (OR)|0.32||||0.3793|TWO_SIDED|95.0|0.02|5.56|||Cochran-Mantel-Haenszel|||||5.56|0.02|0.3793
71020564|NCT03611751|141548220|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0004|TWO_SIDED|95.0|1.29|2.41|||Cochran-Mantel-Haenszel|||||2.41|1.29|0.0004
71020565|NCT03611751|141548221|SUPERIORITY||Odds Ratio (OR)|2.01|||<|0.0001|TWO_SIDED|95.0|1.45|2.78|||Cochran-Mantel-Haenszel|||||2.78|1.45|<0.0001
71020566|NCT03611751|141548222|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||<0.0001
71020567|NCT03611751|141548223|SUPERIORITY||Odds Ratio (OR)|2.47|||<|0.0001|TWO_SIDED|95.0|1.78|3.43|||Cochran-Mantel-Haenszel|||||3.43|1.78|<0.0001
71020568|NCT03611751|141548224|SUPERIORITY||Odds Ratio (OR)|2.44|||<|0.0001|TWO_SIDED|95.0|1.78|3.36|||Cochran-Mantel-Haenszel|||||3.36|1.78|<0.0001
71020569|NCT03611751|141548225|SUPERIORITY||Odds Ratio (OR)|2.07||||0.0001|TWO_SIDED|95.0|1.43|3.01|||Cochran-Mantel-Haenszel|||||3.01|1.43|0.0001
71020570|NCT02441179|141548226|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Kruskal-Wallis|||||||0.006
71020571|NCT02441179|141548227|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Kruskal-Wallis|||||||0.012
71020572|NCT02441179|141548228|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Kruskal-Wallis|||||||0.16
71020573|NCT02441179|141548229|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Chi-squared|||||||0.57
71020574|NCT02441179|141548230|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||Chi-squared|||||||0.14
71020575|NCT02441179|141548231|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.43
71020576|NCT02441179|141548232|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.55
71020577|NCT03056001|141548259|OTHER|Estimation only.|Rate|0.0333|||||TWO_SIDED|95.0|0.0008|0.1722|||||Confidence interval estimated using the Clopper Pearson method.|The reported severe or life-threatening adverse event rate with weekly doxorubicin and dacarbazine was 0.55. If it became evident that the rate of severe or life-threatening toxicity convincingly exceeded 0.55, the study would have been halted. Convincing evidence of exceeding 0.55 was based on Bayesian methods and continuous monitoring, where the stopping rule would have held enrollment if the posterior probability at any point exceeded 0.75 or higher.||0.1722|0.0008|
71020578|NCT03056001|141548260|OTHER|Estimation only|Median|1.3|||||TWO_SIDED|95.0|0.8|2.1|||||The Kaplan Meier method was used to estimate the median OS (in years) for the population. The Greenwood method was used to estimate the confidence limits of the median overall survival.|||2.1|0.8|
71020579|NCT03056001|141548261|OTHER|Estimation only|Median|5.7|||||TWO_SIDED|95.0|4.1|8.3|||||The Kaplan Meier method was used to estimate the median PFS (in months) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||8.3|4.1|
71020580|NCT03056001|141548262|OTHER|Estimation only.|Rate|0.367|||||TWO_SIDED|95.0|0.199|0.561|||||Confidence interval estimated using the Clopper Pearson method.|||0.561|0.199|
71020581|NCT03056001|141548263|OTHER|Estimation only|Median|8.0|||||TWO_SIDED|95.0|2.8|34.6|||||The Kaplan Meier method was used to estimate the median DoR (in months) for the population. The Greenwood method was used to estimate the confidence limits of the median duration of response.|||34.6|2.8|
71020582|NCT03162354|141548319|OTHER||Odds Ratio (OR)|0.64||||0.11|TWO_SIDED|95.0|0.37|1.11||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|We powered this hypothesis to detect a 17% increase (from 73% to 90%) in higher risk patients evaluated thoroughly for abuse at intervention sites, compared to baseline in prior PediBIRN studies. Generalized linear mixed-effects models were adopted to analyze 1,000 Monte Carlo datasets from simulation. For the target sample size of 304 higher risk patients (152 in each arm), the proportion of simulated datasets that yielded a statistically significant result for the primary hypothesis was 95.7%.||1.11|0.37|0.11
71020583|NCT03162354|141548320|OTHER||Odds Ratio (OR)|0.69||||0.49|TWO_SIDED|95.0|0.24|1.98||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||1.98|0.24|0.49
71020584|NCT03162354|141548321|OTHER||Odds Ratio (OR)|1.88||||0.22|TWO_SIDED|95.0|0.69|5.13||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||5.13|0.69|0.22
71020585|NCT03162354|141548322|OTHER||Odds Ratio (OR)|0.48||||0.01|TWO_SIDED|95.0|0.27|0.85||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||0.85|0.27|0.01
71020586|NCT03162354|141548323|OTHER||Odds Ratio (OR)|1.09||||0.84|TWO_SIDED|95.0|0.46|2.6||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||2.60|0.46|0.84
71020587|NCT03162354|141548324|OTHER||Odds Ratio (OR)|1.84||||0.05|TWO_SIDED|95.0|1.0|3.38||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||3.38|1.00|0.05
71020588|NCT03162354|141548325|OTHER||Odds Ratio (OR)|1.22||||0.71|TWO_SIDED|95.0|0.43|3.49||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||3.49|0.43|0.71
71020589|NCT03162354|141548326|OTHER||Odds Ratio (OR)|1.04||||0.86|TWO_SIDED|95.0|0.7|1.53||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||1.53|0.70|0.86
71020590|NCT03162354|141548327|OTHER||Odds Ratio (OR)|2.02||||0.01|TWO_SIDED|95.0|1.16|3.52||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from baseline prior studies to the cluster randomized trial|||3.52|1.16|0.01
71020591|NCT03162354|141548328|OTHER||Odds Ratio (OR)|0.42|||<|0.001|TWO_SIDED|95.0|0.26|0.67||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from baseline in prior studies to the cluster randomized trial.|||0.67|0.26|<.001
71020592|NCT03162354|141548329|OTHER||Odds Ratio (OR)|0.46||||0.14|TWO_SIDED|95.0|0.16|1.31||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from baseline in prior PediBIRN studies to the clinical trial.|||1.31|0.16|0.14
71020593|NCT03162354|141548331|OTHER||Odds Ratio (OR)|0.74||||0.57|TWO_SIDED|95.0|0.27|2.05||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||2.05|0.27|0.57
71020594|NCT03162354|141548332|OTHER||Odds Ratio (OR)|0.63||||0.04|TWO_SIDED|95.0|0.4|0.99||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||0.99|0.40|0.04
71020595|NCT00446134|141548334|NON_INFERIORITY_OR_EQUIVALENCE|The study will have 70% to detect non-inferiority of taribavirin versus ribavirin using a non-inferiority margin of 12%.|Other|12.75|STANDARD_DEVIATION|5.0||0.167|TWO_SIDED|95.0|-3.65|29.15|||Fisher Exact|||||29.15|-3.65|0.167
71020596|NCT00446134|141548334|NON_INFERIORITY_OR_EQUIVALENCE|The study will have 70% to detect non-inferiority of taribavirin versus ribavirin using a non-inferiority margin of 12%.|Difference of Proportion|5.71|STANDARD_DEVIATION|5.0||0.611|TWO_SIDED|95.0|-10.76|22.19|||Fisher Exact|||||22.19|-10.76|0.611
71020597|NCT00446134|141548334|NON_INFERIORITY_OR_EQUIVALENCE|The study will have 70% to detect non-inferiority of taribavirin versus ribavirin using a non-inferiority margin of 12%.|Difference of Proportion|2.98|STANDARD_DEVIATION|5.0||0.736|TWO_SIDED|95.0|-13.67|19.63|||Fisher Exact|||||19.63|-13.67|0.736
71020598|NCT00446134|141548334|NON_INFERIORITY_OR_EQUIVALENCE|The study will have 70% to detect non-inferiority of taribavirin versus taribavirin using a non-inferiority margin of 12%.|Difference of Proportion|7.04|STANDARD_DEVIATION|5.0||0.485|TWO_SIDED|95.0|-9.28|23.35|||Fisher Exact|||||23.35|-9.28|0.485
71020599|NCT00446134|141548334|NON_INFERIORITY_OR_EQUIVALENCE|The study will have 70% to detect non-inferiority of taribavirin versus taribavirin using a non-inferiority margin of 12%.|Difference of Proportion|9.77|STANDARD_DEVIATION|5.0||0.295|TWO_SIDED|95.0|-6.72|26.26|||Fisher Exact|||||26.26|-6.72|0.295
71020600|NCT00446134|141548334|NON_INFERIORITY_OR_EQUIVALENCE|The study will have 70% to detect non-inferiority of taribavirin versus taribavirin using a non-inferiority margin of 12%.|Difference of Proportion|2.73|STANDARD_DEVIATION|5.0||0.864|TWO_SIDED|95.0|-13.84|19.3|||Fisher Exact|||||19.3|-13.84|0.864
71020601|NCT00446134|141548335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.4|STANDARD_DEVIATION|5.0||0.0304|TWO_SIDED|95.0|2.31|30.57|||Chi-squared|||||30.57|2.31|0.0304
71020602|NCT00446134|141548335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.1|STANDARD_DEVIATION|5.0||0.0293|TWO_SIDED|95.0|3.22|31.06|||Chi-squared|||||31.06|3.22|0.0293
71020603|NCT00446134|141548335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9|STANDARD_DEVIATION|5.0||0.5816|TWO_SIDED|95.0|-10.41|20.24|||Chi-squared|||||20.24|-10.41|0.5816
71020604|NCT00446134|141548336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.22|STANDARD_DEVIATION|5.0||0.9999|TWO_SIDED|95.0|-13.78|16.22|||Fisher Exact|||||16.22|-13.78|0.9999
71020605|NCT00446134|141548336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|5.0||0.9999|TWO_SIDED|95.0|-14.73|14.73|||Fisher Exact|||||14.73|-14.73|0.9999
71020606|NCT00446134|141548336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_DEVIATION|5.0||0.9999|TWO_SIDED|95.0|-14.11|15.71|||Fisher Exact|||||15.71|-14.11|0.9999
71020607|NCT00446134|141548336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.22|STANDARD_DEVIATION|5.0||0.9999|TWO_SIDED|95.0|-13.78|16.22|||Fisher Exact|||||16.22|-13.78|0.9999
71020608|NCT00446134|141548336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42|STANDARD_DEVIATION|5.0||0.9999|TWO_SIDED|95.0|-14.76|15.59|||Fisher Exact|||||15.59|-14.76|0.9999
71020609|NCT00446134|141548336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_DEVIATION|5.0||0.9999|TWO_SIDED|95.0|-15.71|14.11|||Fisher Exact|||||14.11|-15.71|0.9999
71020610|NCT00295620|141548358|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.425|TWO_SIDED|95.0|0.79|1.11|||Log Rank|||Arm A: Anastrozole for 2 yerars Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of a DFS event||1.11|0.79|0.425
71020611|NCT00295620|141548359|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.867|TWO_SIDED|95.0|0.83|1.25|||Log Rank|||Arm A: Anastrozole for 2 yerars Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of a death event||1.25|0.83|0.867
71020612|NCT00295620|141548360|SUPERIORITY||Hazard Ratio (HR)|1.35||||0.052|TWO_SIDED|95.0|1.0|1.84|||Log Rank|||Arm A: Anastrozole for 2 yerars Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of a fracture||1.84|1.00|0.052
71020613|NCT00295620|141548361|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.678|TWO_SIDED|95.0|0.81|1.38|||Log Rank|||Arm A: Anastrozole for 2 yerars Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of the occurrence of secondary carcinoma||1.38|0.81|0.678
71020614|NCT00295620|141548362|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.531|TWO_SIDED|95.0|0.75|1.77|||Log Rank|||Arm A: Anastrozole for 2 years Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of the occurrence of contralateral mammacarcinoma||1.77|0.75|0.531
71020615|NCT04179474|141548363|EQUIVALENCE|"No effect of co-administration with erenumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with erenumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%."|Ratio of Geometric Mean Percentage|105.55|||||TWO_SIDED|90.0|96.21|115.79|||||Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Erenumab/Ubrogepant Alone \* 100|A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means.||115.79|96.21|
71053148|NCT03233230|141610698|SUPERIORITY||Response rate difference|0.07||||0.2202|TWO_SIDED|95.0|-0.05|0.19|||Cochran-Mantel-Haenszel|||||0.19|-0.05|0.2202
71053149|NCT03233230|141610698|SUPERIORITY||Response rate difference|0.07||||0.2328|TWO_SIDED|95.0|-0.05|0.19|||Cochran-Mantel-Haenszel|||||0.19|-0.05|0.2328
71053150|NCT03233230|141610699|SUPERIORITY||Response rate difference|0.06||||0.1232|TWO_SIDED|95.0|-0.02|0.15|||Cochran-Mantel-Haenszel|||||0.15|-0.02|0.1232
71053151|NCT03233230|141610699|SUPERIORITY||Response rate difference|0.05||||0.1725|TWO_SIDED|95.0|-0.03|0.14|||Cochran-Mantel-Haenszel|||||0.14|-0.03|0.1725
71053152|NCT03233230|141610699|SUPERIORITY||Response rate difference|0.05||||0.1795|TWO_SIDED|95.0|-0.03|0.13|||Cochran-Mantel-Haenszel|||||0.13|-0.03|0.1795
71053153|NCT03233230|141610707|SUPERIORITY||Response rate difference|0.0|||||TWO_SIDED|95.0|-0.04|0.04||||||||0.04|-0.04|
71053154|NCT03233230|141610707|SUPERIORITY||Response rate difference|0.01|||||TWO_SIDED|95.0|-0.03|0.06||||||||0.06|-0.03|
71053155|NCT03233230|141610707|SUPERIORITY||Response rate difference|0.03|||||TWO_SIDED|95.0|-0.01|0.09||||||||0.09|-0.01|
71053156|NCT03233230|141610708|SUPERIORITY||Response rate difference|0.03|||||TWO_SIDED|95.0|-0.02|0.09||||||||0.09|-0.02|
71053157|NCT03233230|141610708|SUPERIORITY||Response rate difference|0.05|||||TWO_SIDED|95.0|0.0|0.12||||||||0.12|-0.00|
71053158|NCT03233230|141610708|SUPERIORITY||Response rate difference|0.02|||||TWO_SIDED|95.0|-0.03|0.08||||||||0.08|-0.03|
71053159|NCT03233230|141610709|SUPERIORITY||Response rate difference|0.03|||||TWO_SIDED|95.0|-0.01|0.09||||||||0.09|-0.01|
71053160|NCT03233230|141610709|SUPERIORITY||Response rate difference|0.04|||||TWO_SIDED|95.0|0.0|0.1||||||||0.10|0.00|
71053161|NCT03233230|141610709|SUPERIORITY||Response rate difference|0.03|||||TWO_SIDED|95.0|-0.01|0.09||||||||0.09|-0.01|
71053162|NCT03233230|141610710|SUPERIORITY||Response rate difference|0.11|||||TWO_SIDED|95.0|-0.03|0.24||||||||0.24|-0.03|
71053163|NCT03233230|141610710|SUPERIORITY||Response rate difference|0.12|||||TWO_SIDED|95.0|-0.02|0.25||||||||0.25|-0.02|
71053164|NCT03233230|141610710|SUPERIORITY||Response rate difference|0.18|||||TWO_SIDED|95.0|0.05|0.31||||||||0.31|0.05|
71053165|NCT00392236|141610749|SUPERIORITY_OR_OTHER|||||||0.083|||||||ANOVA|||||||0.083
71053166|NCT03275064|141610824|SUPERIORITY||Mean Difference (Net)|0.48|||||TWO_SIDED|90.0|-30.73|31.69|||Mixed Models Analysis|||Week 16||31.69|-30.73|
71053167|NCT03275064|141610824|SUPERIORITY||Mean Difference (Net)|3.68|||||TWO_SIDED|90.0|-27.04|34.4|||Mixed Models Analysis|||Week 28||34.40|-27.04|
71053168|NCT03275064|141610825|SUPERIORITY||Mean Difference (Final Values)|1.69|||||TWO_SIDED|90.0|-27.7|31.08|||Mixed Models Analysis|||Week 16||31.08|-27.70|
71053169|NCT03275064|141610825|SUPERIORITY||Mean Difference (Net)|5.97|||||TWO_SIDED|90.0|-23.03|34.97|||Mixed Models Analysis|||Week 28||34.97|-23.03|
71053170|NCT03275064|141610826|SUPERIORITY||Mean Difference (Net)|0.88|||||TWO_SIDED|90.0|-47.27|49.04|||Mixed Models Analysis|||Week 16||49.04|-47.27|
71053171|NCT03275064|141610826|SUPERIORITY||Mean Difference (Net)|2.27|||||TWO_SIDED|90.0|-43.11|47.65|||Mixed Models Analysis|||Week 28||47.65|-43.11|
71053172|NCT03275064|141610827|SUPERIORITY|Week 29|Mean Difference (Net)|200.18||||0.0131|TWO_SIDED|90.0|54.53|345.83|||Mixed Models Analysis|||||345.83|54.53|0.0131
71053173|NCT03275064|141610827|SUPERIORITY||Mean Difference (Net)|141.87||||0.0544|TWO_SIDED|90.0|-3.83|287.56|||Mixed Models Analysis|||Week 29||287.56|-3.83|0.0544
71053174|NCT03275064|141610827|SUPERIORITY||Mean Difference (Net)|228.27||||0.0067|TWO_SIDED|90.0|80.87|375.67|||Mixed Models Analysis|||Week 53||375.67|80.87|0.0067
71053175|NCT03275064|141610827|SUPERIORITY||Mean Difference (Net)|116.21||||0.0931|TWO_SIDED|90.0|-29.52|261.94|||Mixed Models Analysis|||Week 53||261.94|-29.52|0.0931
71053176|NCT03275064|141610828|SUPERIORITY||Mean Difference (Net)|0.05||||0.0574|TWO_SIDED|90.0|0.0|0.1|||Mixed Models Analysis|||Week 29||0.10|-0.00|0.0574
71053177|NCT03275064|141610828|SUPERIORITY||Mean Difference (Net)|0.06||||0.0248|TWO_SIDED|90.0|0.01|0.11|||Mixed Models Analysis|||Week 29||0.11|0.01|0.0248
71053178|NCT03275064|141610828|SUPERIORITY||Mean Difference (Net)|0.01||||0.3864|TWO_SIDED|90.0|-0.05|0.07|||Mixed Models Analysis|||Week 53||0.07|-0.05|0.3864
70932471|NCT02307682|141364362|OTHER|Treatment difference|Least squares mean difference|0.18|||||TWO_SIDED|95.0|-1.6|1.9||Hypothesis testing not pre-specified.|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 72||1.9|-1.6|
71106312|NCT00718315|141719524|SUPERIORITY_OR_OTHER|||||||0.481||||||Test for Binomial Ratio, where H0: P \>=61%; Ha: P \< 61% (One-tailed Test)|t-test, 1 sided|||||||0.481
70932472|NCT02307682|141364362|OTHER|Treatment difference|Least squares mean difference|-0.12|||||TWO_SIDED|95.0|-1.9|1.7||Hypothesis testing not pre-specified|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||1.7|-1.9|
70932473|NCT02307682|141364362|OTHER|Treatment difference|Least squares mean difference|0.75|||||TWO_SIDED|95.0|-1.2|2.7||Hypothesis testing not pre-specified|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 96||2.7|-1.2|
70932474|NCT02307682|141364362|OTHER|Treatment difference|Least squares mean difference|1.05|||||TWO_SIDED|95.0|-0.9|3.0||Hypothesis testing not pre-specified.|ANCOVA|nalyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||3.0|-0.9|
71106313|NCT00718315|141719524|SUPERIORITY_OR_OTHER|||||||0.933||||||Test for Binomial Ratio, where H0: P \>=61%; Ha: P \< 61% (One-tailed Test)|t-test, 1 sided|||||||0.933
70932475|NCT05630833|141364366|OTHER||Lower 10th percentile (%)|48.2|||||||||||||Lower 10th percentile of therapeutic successes was calculated from the predictive distribution.|As defined in Statistical Analysis Plan, consistency with the global studies is demonstrated if the success criterion for gepotidacin is set to require a therapeutic response rate greater than lower 10th percentile value of the predictive distribution.||||
70932476|NCT03905694|141364401|OTHER|Not applied|Least Squares (LS) Mean|-71.97|||||TWO_SIDED|95.0|-77.52|-66.42|||Mixed model for repeated measures (MMRM)|||Mixed-effect Model Repeated Measures (MMRM) includes scheduled visits (months 3, 4, 5, and 6) and baseline spot urinary oxalate:creatine ratio as fixed effects. Autoregressive (1) was used to model the within-patient error.||-66.42|-77.52|
70932477|NCT04551066|141364478|SUPERIORITY||Odds Ratio (OR)|1.47||||0.2019|TWO_SIDED|95.0|0.81|2.65||calculated from Cochran Mantel-Haenszel test stratified by Baseline platelet count ≥100 x 10\^9/Liters versus 50 to \<100 x 10\^9/Liters inclusive|Cochran-Mantel-Haenszel|||||2.65|0.81|0.2019
70932478|NCT04551066|141364479|SUPERIORITY||Odds Ratio (OR)|0.83||||0.5356|TWO_SIDED|95.0|0.46|1.5||calculated from Cochran Mantel-Haenszel test stratified by Baseline platelet count ≥100 x 10\^9/Liters versus 50 to \<100 x 10\^9/Liters inclusive|Cochran-Mantel-Haenszel|||||1.50|0.46|0.5356
70932479|NCT04551066|141364481|SUPERIORITY|||||||0.9354||||||calculated from log-rank test stratified by Baseline platelet count ≥100 × 10\^9/Liters versus 50 to \<100 × 10\^9/Liters inclusive|Log Rank|||||||0.9354
70932480|NCT04551066|141364485|SUPERIORITY|||||||0.0945||||||calculated from log-rank test stratified by Baseline platelet count ≥100 × 10\^9/Liters versus 50 to \<100 × 10\^9/Liters inclusive|Log Rank|||||||0.0945
70932481|NCT02760654|141364527|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
70932482|NCT02760654|141364528|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
70932483|NCT02760654|141364529|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
70932484|NCT02760654|141364530|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
71053179|NCT03275064|141610828|SUPERIORITY||Mean Difference (Net)|0.02||||0.329|TWO_SIDED|90.0|-0.05|0.08|||Mixed Models Analysis|||Week 53||0.08|-0.05|0.3290
71053180|NCT03275064|141610829|SUPERIORITY||Mean Difference (Net)|4.75||||0.6184|TWO_SIDED|90.0|-21.36|30.85|||Mixed Models Analysis|||Week 16||30.85|-21.36|0.6184
71053181|NCT03275064|141610829|OTHER||Mean Difference (Net)|-7.32||||0.3194|TWO_SIDED|90.0|-33.16|18.53|||Mixed Models Analysis|||Week 28||18.53|-33.16|0.3194
71053182|NCT03275064|141610830|SUPERIORITY||Mean Difference (Net)|3.38|||||TWO_SIDED|90.0|-1.72|8.47|||Mixed Models Analysis|||Week 29||8.47|-1.72|
71053183|NCT03275064|141610830|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|90.0|-5.22|5.01|||Mixed Models Analysis|||Week 29||5.01|-5.22|
71053184|NCT03275064|141610830|SUPERIORITY||Mean Difference (Net)|-1.14|||||TWO_SIDED|90.0|-6.42|4.15|||Mixed Models Analysis|||Week 53||4.15|-6.42|
71053185|NCT03275064|141610830|SUPERIORITY||Mean Difference (Net)|-7.44|||||TWO_SIDED|90.0|-12.68|-2.2|||Mixed Models Analysis|||Week 53||-2.20|-12.68|
71053186|NCT03275064|141610831|SUPERIORITY||Mean Difference (Net)|2.09|||||TWO_SIDED|90.0|-3.49|7.66|||Mixed Models Analysis|||Week 29||7.66|-3.49|
71053187|NCT03275064|141610831|SUPERIORITY||Mean Difference (Net)|0.82|||||TWO_SIDED|90.0|-4.82|6.45|||Mixed Models Analysis|||Week 29||6.45|-4.82|
71053188|NCT03275064|141610831|SUPERIORITY||Mean Difference (Net)|2.29|||||TWO_SIDED|90.0|-3.54|8.11|||Mixed Models Analysis|||Week 53||8.11|-3.54|
71053189|NCT03275064|141610831|SUPERIORITY||Mean Difference (Net)|-5.96|||||TWO_SIDED|90.0|-11.81|-0.1|||Mixed Models Analysis|||Week 53||-0.10|-11.81|
71053190|NCT03275064|141610832|SUPERIORITY||Mean Difference (Net)|3.47|||||TWO_SIDED|90.0|-2.21|9.15|||Mixed Models Analysis|||Week 29||9.15|-2.21|
71053191|NCT03275064|141610832|SUPERIORITY||Mean Difference (Net)|-0.63|||||TWO_SIDED|90.0|-6.31|5.04|||Mixed Models Analysis|||Week 29||5.04|-6.31|
71053192|NCT03275064|141610832|SUPERIORITY||Mean Difference (Net)|-2.63|||||TWO_SIDED|90.0|-8.07|2.82|||Mixed Models Analysis|||Week 53||2.82|-8.07|
71053193|NCT03275064|141610832|SUPERIORITY||Mean Difference (Net)|-8.16|||||TWO_SIDED|90.0|-13.61|-2.72|||Mixed Models Analysis|||Week 53||-2.72|-13.61|
71106314|NCT00718315|141719524|SUPERIORITY_OR_OTHER|||||||0.986||||||Test for Binomial Ratio, where H0: P \>=61%; Ha: P \< 61% (One-tailed Test)|t-test, 1 sided|||||||0.986
71020616|NCT04179474|141548364|EQUIVALENCE|"No effect of co-administration with galcanezumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with galcanezumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%."|Ratio of Geometric Mean Percentage|105.03|||||TWO_SIDED|90.0|89.55|123.19|||||Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Galcanezumab/Ubrogepant Alone \* 100|A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means.||123.19|89.55|
71106315|NCT00718315|141719526|SUPERIORITY_OR_OTHER|||||||0.095|||||||Log Rank|||||||0.095
71020617|NCT04179474|141548365|EQUIVALENCE|"No effect of co-administration with erenumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with erenumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%."|Ratio of Geometric Mean Percentage|105.38|||||TWO_SIDED|90.0|96.19|115.45|||||Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Erenumab/Ubrogepant Alone \* 100|A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means.||115.45|96.19|
71106316|NCT00718315|141719527|SUPERIORITY_OR_OTHER|||||||0.199|||||||Chi-squared|||||||0.199
71106317|NCT00718315|141719528|SUPERIORITY_OR_OTHER|||||||0.108|||||||Chi-squared|||||||0.108
71106318|NCT00718315|141719529|SUPERIORITY_OR_OTHER|||||||0.179|||||||Chi-squared|||||||0.179
71106319|NCT00718315|141719530|SUPERIORITY_OR_OTHER|||||||0.066|||||||Kruskal-Wallis|||||||0.066
71106320|NCT00718315|141719531|SUPERIORITY_OR_OTHER|||||||0.087|||||||Kruskal-Wallis|||||||0.087
71053194|NCT04159935|141610844|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.400
71053195|NCT04159935|141610845|OTHER|||||||0.057|||||||Wilcoxon (Mann-Whitney)|||||||0.057
71053196|NCT04159935|141610846|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
71106321|NCT00718315|141719532|SUPERIORITY_OR_OTHER|||||||0.308|||||||Kruskal-Wallis|||||||0.308
71106322|NCT01170663|141719533|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.807||||0.0169|TWO_SIDED|95.0|0.678|0.962|||Stratified Log Rank Test|Adjusted for stratification factors: geographic region, time-to-progression from start of first-line therapy and disease measurability.||||0.962|0.678|0.0169
71106323|NCT01170663|141719534|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.635|||<|0.0001|TWO_SIDED|95.0|0.536|0.752|||Stratified Log Rank Test|Adjusted for stratification factors: geographic region, time-to-progression from start of first-line therapy and disease measurability.||||0.752|0.536|<0.0001
71106324|NCT01170663|141719535|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.596|||<|0.0001|TWO_SIDED|95.0|0.494|0.72|||Stratified Log Rank Test|Adjusted for stratification factors: geographic region, time-to-progression from start of first-line therapy and disease measurability.||||0.720|0.494|<0.0001
71106325|NCT01170663|141719537|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.14||||0.0001|TWO_SIDED|95.0|1.45|3.16|||Cochran-Mantel-Haenszel|Adjusted for stratification factors: geographic region, time-to-progression from the start of first-line therapy and disease measurability.||||3.16|1.45|0.0001
71106326|NCT01170663|141719545|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3973||||||Analysis of covariance (ANCOVA) included treatment group, randomization stratification factors and baseline value of Global Health Status scale.|ANCOVA|||||||0.3973
71106327|NCT01128569|141719574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|||||TWO_SIDED|95.0|0.087|0.237||||||||0.237|0.087|
71106328|NCT01128569|141719574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|||||TWO_SIDED|95.0|0.069|0.222||||||||0.222|0.069|
70851326|NCT00669409|141190545|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.8|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-31.6|12.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.0|-31.6|
70932485|NCT02760654|141364531|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
71053197|NCT04159935|141610848|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.400
71053198|NCT04159935|141610849|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.400
71053199|NCT04159935|141610850|OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.500
71053200|NCT04159935|141610851|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
71053201|NCT04159935|141610852|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.400
71053202|NCT04159935|141610854|OTHER|||||||0.343|||||||Wilcoxon (Mann-Whitney)|||||||0.343
71053203|NCT04159935|141610855|OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.700
71053204|NCT04159935|141610856|OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.500
71106329|NCT01128569|141719574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.017|||||TWO_SIDED|95.0|-0.091|0.057||||||||0.057|-0.091|
71106330|NCT02519842|141719579|OTHER||Mean Difference (Final Values)|9.8|||||TWO_SIDED|95.0|-7.6|27.9|||||Mean difference in percentage of participants who experienced at least 1 tier 2 AE and received fosaprepitant regimen compared with participants who received control regimen.|||27.9|-7.6|
71106331|NCT02519842|141719580|OTHER||Mean Difference (Final Values)|5.4|||||TWO_SIDED|95.0|-5.1|17.8|||||Mean difference in percentage of participants who discontinued due to an AE and received fosaprepitant regimen compared with participants who received control regimen.|||17.8|-5.1|
71106332|NCT01977222|141719663|OTHER|||||||0.1673|||||||t-test, 2 sided|||||||0.1673
71106333|NCT01977222|141719664|OTHER|||||||0.5745|||||||t-test, 2 sided|||||||0.5745
71106334|NCT01977222|141719665|OTHER|||||||0.511|||||||t-test, 2 sided|||||||.511
71106335|NCT01977222|141719666|OTHER|||||||0.776|||||||t-test, 2 sided|||||||0.776
71106336|NCT01977222|141719667|OTHER|||||||0.5374|||||||t-test, 2 sided|||||||0.5374
71106337|NCT01977222|141719668|OTHER|||||||0.3385|||||||t-test, 2 sided|||||||0.3385
71106338|NCT01977222|141719669|OTHER|||||||0.0189|||||||t-test, 2 sided|||||||0.0189
71106339|NCT01977222|141719670|OTHER|||||||0.1183|||||||t-test, 2 sided|||||||0.1183
71106340|NCT01605669|141719683|SUPERIORITY_OR_OTHER||Percentage Sensitivity|85.7||||||95.0||||||||||||
71106341|NCT01605669|141719683|SUPERIORITY_OR_OTHER||Percent Specificity|72.4||||||95.0||||||||||||
71106342|NCT01605669|141719683|SUPERIORITY_OR_OTHER||Percent Error Rate|25.0||||||95.0|||||||Error rate of 9/36 is equal to total of false positives plus false negatives over the total of participants analyzed.|||||
71053205|NCT00724048|141610867|SUPERIORITY||Mean Difference (Final Values)|-1.17||||0.078|TWO_SIDED|95.0|-2.47|0.13|||ANCOVA|||The ANCOVA model included a term for treatment, as well as covariates for baseline mMS, and age at entry to the study.||0.13|-2.47|0.078
71020618|NCT04179474|141548366|EQUIVALENCE|"No effect of co-administration with galcanezumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with galcanezumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%."|Ratio of Geometric Mean Percentage|104.76|||||TWO_SIDED|90.0|89.68|122.38|||||Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Galcanezumab/Ubrogepant Alone \* 100|A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means.||122.38|89.68|
71053206|NCT00724048|141610867|SUPERIORITY||Mean Difference (Final Values)|-1.19||||0.084|TWO_SIDED|95.0|-2.53|0.16||Hypothesis testing was completed only if ACR16 45 mg BID (90 mg) vs. placebo was significant.|ANCOVA|||The ANCOVA model included a term for treatment, as well as covariates for baseline mMS, and age at entry to the study.||0.16|-2.53|0.084
71053207|NCT00724048|141610867|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.982|TWO_SIDED|95.0|-1.35|1.32||Hypothesis testing was completed only if ACR16 22.5 mg BID (45 mg) vs. placebo was significant.|ANCOVA|||The ANCOVA model included a term for treatment, as well as covariates for baseline mMS, and age at entry to the study.||1.32|-1.35|0.982
71053208|NCT03923530|141610874|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.12
70932486|NCT02760654|141364532|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
71020619|NCT04179474|141548367|EQUIVALENCE|"No effect of co-administration with erenumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with erenumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%."|Ratio of Geometric Mean Percentage|103.86|||||TWO_SIDED|90.0|93.01|115.98|||||Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Erenumab/Ubrogepant Alone \* 100|A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means||115.98|93.01|
71020620|NCT04179474|141548368|EQUIVALENCE|"No effect of co-administration with galcanezumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with galcanezumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%."|Ratio of Geometric Mean Percentage|99.55|||||TWO_SIDED|90.0|82.27|120.45|||||Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Galcanezumab/Ubrogepant Alone \* 100|A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means.||120.45|82.27|
71020621|NCT02556632|141548384|OTHER|||||||0.9306|||||||ANOVA|||||||0.9306
71020622|NCT02556632|141548385|OTHER|||||||0.8048|||||||Fisher Exact|||||||0.8048
71020623|NCT02556632|141548386|OTHER|||||||0.8591|||||||ANOVA|||||||0.8591
71020624|NCT01164137|141548404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.87|TWO_SIDED|95.0|-0.98|0.84|||t-test, 2 sided|||||.84|-.98|.87
71020625|NCT01164137|141548405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.32|TWO_SIDED|95.0|-0.62|1.88|||t-test, 2 sided|||||1.88|-.62|.32
71020626|NCT01164137|141548406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21||||0.18|TWO_SIDED|95.0|-0.57|3.01|||t-test, 2 sided|||||3.01|-.57|.18
71020627|NCT01164137|141548407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.71||||0.11|TWO_SIDED|95.0|-0.39|3.81|||t-test, 2 sided|||||3.81|-.39|.11
71020628|NCT01164137|141548408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.85||||0.13|TWO_SIDED|95.0|-0.56|4.27|||t-test, 2 sided|||||4.27|-.56|.13
70932487|NCT02760654|141364533|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
70932488|NCT02760654|141364534|EQUIVALENCE|Descriptive statistics (Mean, SD) were calculated for the 7 items of the Adapted Acceptability E-Scale|Calculated Mean and Standard Deviation|0.05|||||TWO_SIDED|||||||||||||
70932489|NCT02760654|141364535|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
70932490|NCT02760654|141364536|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
71020629|NCT04523831|141548409|SUPERIORITY||Cox Proportional Hazard|0.53|||<|0.03|TWO_SIDED|95.0|0.3|0.96|||Regression, Linear|||||0.96|0.30|<0.03
71020630|NCT04523831|141548410|SUPERIORITY||Cox Proportional Hazard|0.51|||<|0.004|TWO_SIDED|95.0|0.32|0.8|||Regression, Logistic|||||0.80|0.32|<0.004
71020631|NCT04523831|141548411|SUPERIORITY||Cox Proportional Hazard|0.45|||<|0.013|TWO_SIDED|95.0|0.23|0.85|||Regression, Logistic|||||0.85|0.23|<0.013
71020632|NCT04523831|141548412|SUPERIORITY||Cox Proportional Hazard|0.58|||<|0.001|TWO_SIDED|95.0|0.44|0.81|||Regression, Logistic|||||0.81|0.44|<0.001
71020633|NCT02367781|141548425|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.639|||<|0.0001|TWO_SIDED|95.0|0.536|0.763|||Log Rank|||||0.763|0.536|<.0001
71020634|NCT02367781|141548426|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.788||||0.0298|TWO_SIDED|95.0|0.636|0.977|||Log Rank|||||0.977|0.636|0.0298
71020635|NCT02367781|141548427|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.647|||<|0.0001|TWO_SIDED|95.0|0.545|0.768|||Log Rank|||ITT Population||0.768|0.545|<0.0001
71020636|NCT02367781|141548427|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.561|||<|0.0001|TWO_SIDED|95.0|0.432|0.728|||Log Rank|||TC1/2/3 or IC1/2/3-WT ITT Population||0.728|0.432|<0.0001
71053209|NCT03923530|141610875|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.49
71053210|NCT03923530|141610876|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.03
71053211|NCT03923530|141610877|SUPERIORITY|||||||0.27|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.27
71053212|NCT03923530|141610878|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.18
71053213|NCT03923530|141610879|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.8
71053214|NCT03923530|141610880|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.76
71079506|NCT00482170|141666456|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.197|TWO_SIDED|95.0|0.55|1.13||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.13|0.55|0.197
71053215|NCT00911807|141610881|SUPERIORITY_OR_OTHER||Mean Square (Factor Treatment)|19.59||||0.6348||||||ANCOVA F-test. The study was designed to show significant differences in each of the two primary variables. No adjustment for multiple testing was needed and all tests were done with retention of the full two-sided alpha-level of 0.05.|ANCOVA|ANCOVA with the week 28 ADAS-cog+ change score as dependent variable and the ADAS-cog+ baseline score as a covariate.||The null-hypothesis stated no differences between the three treatment groups regarding the mean change from baseline in ADAS-cog+ at week 28. A sample size of approximately 60 evaluable patients per treatment arm was estimated to allow for the detection of a significant group difference of two points in ADAS-cog+ week 28 change score (standard deviation \[SD\] 3.3) between the three groups with a power of \> 80% and a probability level of alpha = 0.05 (two-sided).||||0.6348
71053216|NCT00911807|141610881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63||||0.583||95.0|-2.891|1.63||No adjustment for multiple testing was needed and all tests were done with retention of the full two-sided alpha-level of 0.05.|t-test, 2 sided|Comparisons between all pair of means were performed with two-sample t-tests within the ANCOVA model.||Multiple testing of individual null hypotheses that control for the overall significance level alpha = 0.05 were performed by using the 'closed testing procedure'||1.630|-2.891|0.5830
71053217|NCT00911807|141610881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.3434||95.0|-3.324|1.163||No adjustment for multiple testing was needed and all tests were done with retention of the full two-sided alpha-level of 0.05.|t-test, 2 sided|Comparisons between all pair of means were performed with two-sample t-tests within the ANCOVA model.||Multiple testing of individual null hypotheses that control for the overall significance level alpha = 0.05 were performed by using the 'closed testing procedure'.||1.163|-3.324|0.3434
71020637|NCT02367781|141548427|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.549|||<|0.0001|TWO_SIDED|95.0|0.425|0.708|||Log Rank|||TC1/2/3 or IC1/2/3 ITT Population||0.708|0.425|<0.0001
71020638|NCT02367781|141548428|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.837||||0.0732|TWO_SIDED|95.0|0.689|1.017|||Log Rank|||||1.017|0.689|0.0732
71020639|NCT02367781|141548429|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.752||||0.083|TWO_SIDED|95.0|0.545|1.039|||Log Rank|||TC1/2/3 or IC1/2/3 ITT Population||1.039|0.545|0.0830
71020640|NCT02367781|141548429|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.746||||0.0813|TWO_SIDED|95.0|0.536|1.038|||Log Rank|||TC1/2/3 or IC1/2/3 WT ITT Population||1.038|0.536|0.0813
71020641|NCT02367781|141548430|SUPERIORITY|Stratified Analysis|Difference in Response Rate|19.21|||<|0.0001|TWO_SIDED|95.0|11.05|27.37|||Cochran-Mantel-Haenszel||Wald with Continuity Correction|||27.37|11.05|<.0001
71079507|NCT00482170|141666456|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.212|TWO_SIDED|95.0|0.56|1.14||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.14|0.56|0.212
71020642|NCT02367781|141548431|SUPERIORITY|Unstratified Analysis|Difference in Response Rate|16.89|||<|0.0001|TWO_SIDED|95.0|8.9|24.88|||Cochran-Mantel-Haenszel||Wald with Continuity Correction|ITT Population||24.88|8.90|<.0001
71020643|NCT02367781|141548431|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.22|||||TWO_SIDED|95.0|1.38|3.56||||||TC1/2/3 or IC1/2/3 ITT WT Population||3.56|1.38|
71020644|NCT02367781|141548431|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.21||||0.0007|TWO_SIDED|95.0|1.39|3.51|||Cochran-Mantel-Haenszel|||TC1/2/3 or IC1/2/3 ITT Population||3.51|1.39|0.0007
71020645|NCT02367781|141548432|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.614||||0.0002|TWO_SIDED|95.0|0.473|0.797|||Log Rank|||ITT Population||0.797|0.473|0.0002
71020646|NCT02367781|141548432|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.6||||0.0002|TWO_SIDED|95.0|0.458|0.785|||Log Rank|||ITT-WT Population||0.785|0.458|0.0002
71020647|NCT02367781|141548432|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.548||||0.0011|TWO_SIDED|95.0|0.379|0.791|||Log Rank|||TC1/2/3 or IC1/2/3 ITT Population||0.791|0.379|0.0011
71020648|NCT02367781|141548432|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.551||||0.0014|TWO_SIDED|95.0|0.381|0.798|||Log Rank|||TC1/2/3 or IC1/2/3 ITT WT Population||0.798|0.381|0.0014
71020649|NCT02367781|141548433|SUPERIORITY||Difference in Event Free Rate|7.46||||0.0647|TWO_SIDED|95.0|-0.45|15.37|||Z-test|||Event Free Rate (%) at Year 1 ITT WT Population||15.37|-0.45|0.0647
71020650|NCT02367781|141548433|SUPERIORITY||Difference in Event Free Rate|8.07||||0.0516|TWO_SIDED|95.0|-0.06|16.19|||Z-test|||Event Free Rate (%) at Year 2 ITT WT Population||16.19|-0.06|0.0516
71020651|NCT02367781|141548433|SUPERIORITY||Difference in Event Free Rate|7.19||||0.0683|TWO_SIDED|95.0|-0.54|14.91|||Z-test|||Event Free Rate (%) at Year 1 ITT Population||14.91|-0.54|0.0683
71020652|NCT02367781|141548433|SUPERIORITY||Difference in Event Free Rate|7.53||||0.0625|TWO_SIDED|95.0|-0.39|15.44|||Z-test|||Event Free Rate (%) at Year 2 ITT Population||15.44|-0.39|0.0625
71020653|NCT02367781|141548434|SUPERIORITY||Difference in Event Free Rate|6.69||||0.2385|TWO_SIDED|95.0|-4.44|17.83|||Z-test|||Event Free Rate (%) at Year 1 TC1/2/3 or IC1/2/3 ITT||17.83|-4.44|0.2385
71020654|NCT02367781|141548434|SUPERIORITY||Difference in Event Free Rate|8.64||||0.271|TWO_SIDED|95.0|-6.75|24.03|||Z-test|||Event Free Rate (%) at Year 2 TC1/2/3 or IC1/2/3 ITT||24.03|-6.75|0.2710
71020655|NCT02367781|141548434|SUPERIORITY||Difference in Event Free Rate|6.34||||0.2733|TWO_SIDED|95.0|-5.0|17.67|||Z-test|||Event Free Rate (%) Year 1 TC1/2/3 or IC1/2/3 ITT WT||17.67|-5.00|0.2733
71020656|NCT02367781|141548434|SUPERIORITY||Difference in Event Free Rate|8.69||||0.2909|TWO_SIDED|95.0|-7.44|24.81|||Z-test|||Event Free Rate (%) Year 2 TC1/2/3 or IC1/2/3 ITT WT||24.81|-7.44|0.2909
71020657|NCT02367781|141548435|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.893||||0.3342|TWO_SIDED|95.0|0.711|1.123|||Log Rank|||||1.123|0.711|0.3342
71079508|NCT00482170|141666457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.35||0.515|TWO_SIDED|95.0|-0.91|0.46||Statistical testing, 2-sided, was done at 5% significance level.|ANOVA|||Baseline- after the training: Mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an auto-regressive correlation structure was used to calculate 95% CI.||0.46|-0.91|0.515
71079509|NCT00482170|141666457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.34||0.842|TWO_SIDED|95.0|-0.74|0.6||Statistical testing, 2-sided, was done at 5% significance level.|ANOVA|||Week 4: Mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an unstructured correlation was used for the analysis.||0.60|-0.74|0.842
71020658|NCT02623426|141548443|SUPERIORITY||Ratio of the proportion of baseline|1.36|||<|0.001|TWO_SIDED|95.0|1.19|1.56||A Bonferroni correction was used to adjust for the co-primary hypotheses;a two-sided type I error rate of 0.05/2 = 0.025 was used to determine statistical significance for the two pairwise comparisons (Ozurdex vs Methotrexate and Ozurdex vs Lucentis)|mixed effects model||The treatment effect is the ratio of the proportions of baseline retinal thickness (Methotrexate/Ozurdex). Values greater than 1 indicate less reduction in retinal thickness in the Methotrexate treated group compared to Ozurdex|A sample size of 240 was calculated to provide 91% power to detect a 25% reduction for Ozurdex, a 38% reduction for Methotrexate and Lucentis assuming a standard deviation of 0.33, 25% with bilateral disease, between-eye correlation of 0.4, 10% loss to follow-up, and a two-sided type 1 error rate of 0.025 for each pairwise comparison.||1.56|1.19|<0.001
71020659|NCT02623426|141548443|SUPERIORITY||Ratio of the proportion of BL|1.22||||0.012|TWO_SIDED|95.0|1.04|1.43||A Bonferroni correction was used to adjust for the co-primary hypotheses;a two-sided type I error rate of 0.05/2 = 0.025 was used to determine statistical significance for the two pairwise comparisons (Ozurdex vs Methotrexate and Ozurdex vs Lucentis)|mixed effects model||The treatment effect is the ratio of the proportions of baseline retinal thickness (Lucentis/Ozurdex) at 12 weeks. Values greater than 1 indicate less reduction in retinal thickness in the Lucentis treated group compared to Ozurdex|A sample size of 240 was calculated to provide 91% power to detect a 25% reduction for Ozurdex, a 38% reduction for methotrexate and Lucentis assuming a standard deviation of 0.33, 25% with bilateral disease, between-eye correlation of 0.4, 10% loss to follow-up, and a two-sided type 1 error rate of 0.025 for each pairwise comparison.||1.43|1.04|0.012
71020660|NCT01142466|141548468|SUPERIORITY_OR_OTHER|||||||0.1384|||||||Log Rank|||Two-sided log rank test with alpha equal to 0.05 was used as the appropriate nonparametric method to compare the two groups.||||0.1384
71020661|NCT01142466|141548469|SUPERIORITY_OR_OTHER|||||||0.2635||95.0|||||Fisher Exact|||||||0.2635
71020662|NCT00681824|141548475|SUPERIORITY_OR_OTHER|||||||0.7159||95.0|||||likelihood ratio of chi squared test|||||||0.7159
71020663|NCT03712137|141548523|SUPERIORITY||Responder Rate Difference|30.9||||0.0001|TWO_SIDED|95.0|15.33|46.54|||Multiple Imputation|The procedure used to perform Multiple Imputation is PROC MIANALYZE in SAS with normal approximation||||46.54|15.33|0.0001
71020664|NCT03712137|141548526|SUPERIORITY||Mean Difference (Final Values)|45.9|||<|0.0001|TWO_SIDED|95.0|40.45|51.28|||Paired T-test|||||51.28|40.45|<0.0001
71053218|NCT00911807|141610881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.6962||95.0|-2.719|1.819||No adjustment for multiple testing was needed and all tests were done with retention of the full two-sided alpha-level of 0.05.|t-test, 2 sided|Comparisons between all pair of means were performed with two-sample t-tests within the ANCOVA model.||Multiple testing of individual null hypotheses that control for the overall significance level alpha = 0.05 were performed by using the 'closed testing procedure'.||1.819|-2.719|0.6962
71053219|NCT01672970|141610919|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical analysis at Month 3||||0.000
71053220|NCT01672970|141610919|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6||||0.000
71053221|NCT01672970|141610920|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3||||0.001
71053222|NCT01672970|141610920|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6||||0.005
71053223|NCT01672970|141610921|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3||||0.000
71053224|NCT01672970|141610921|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6||||0.000
71053225|NCT01672970|141610922|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3||||0.000
71053226|NCT01672970|141610922|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.001
71053227|NCT01672970|141610925|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 3||||0.000
71053228|NCT01672970|141610925|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 6||||0.000
71053229|NCT01672970|141610926|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 3||||0.000
71053230|NCT01672970|141610926|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 6||||0.000
71053231|NCT01672970|141610931|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 3||||0.000
71053232|NCT01672970|141610931|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 6||||0.000
71053233|NCT01672970|141610932|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 3||||0.000
71053234|NCT01672970|141610932|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 6||||0.000
71053235|NCT01672970|141610933|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 3||||0.000
71053236|NCT01672970|141610933|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 6||||0.000
71053237|NCT01672970|141610934|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3||||0.000
71053238|NCT01672970|141610934|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6||||0.000
71053239|NCT01672970|141610935|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3||||0.000
71053240|NCT01672970|141610935|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6||||0.000
71053241|NCT01672970|141610936|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3||||0.000
71053242|NCT01672970|141610936|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6||||0.000
71053243|NCT01997229|141610937|SUPERIORITY||Mean Difference (Net)|-11.7||||0.0698|TWO_SIDED|95.0|-24.33|0.96|||ANCOVA|||||0.96|-24.33|0.0698
71053244|NCT02304991|141610938|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||Intent to treat; participants not completing the DBPCFC considered to have challenge score of zero||||0.002
70932491|NCT00945321|141364546|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|0.93||||0.001|TWO_SIDED|95.0|0.84|1.02||Hochberg's step-up procedure was applied to preserve the overall alpha level for the primary hypothesis that involved comparison at two oral dose levels.|two one-sided tests|The P-value obtained was the maximum of two P-values from two one-sided tests (GMR (Oral/IV) ≤0.80 vs. GMR\>0.80 and GMR≥1.25 vs. GMR\<1.25).||||1.02|0.84|0.001
70932492|NCT00945321|141364546|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.96|1.15||Hochberg's step-up procedure was applied to preserve the overall alpha level for the primary hypothesis that involved comparison at two oral dose levels|two one-sided tests|The P-value obtained was the maximum of two P-values from two one-sided tests (GMR (Oral/IV) ≤0.80 vs. GMR\>0.80 and GMR≥1.25 vs. GMR\<1.25).||||1.15|0.96|<0.001
70932493|NCT00945321|141364546|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.47|||||TWO_SIDED|90.0|1.23|1.76||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.76|1.23|
70932494|NCT00945321|141364546|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.08|||||TWO_SIDED|90.0|0.88|1.32||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.32|0.88|
70932495|NCT00945321|141364546|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.22|||||TWO_SIDED|90.0|1.01|1.46||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.46|1.01|
70932496|NCT00945321|141364546|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.43|||||TWO_SIDED|90.0|1.16|1.75||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.75|1.16|
70932497|NCT00945321|141364547|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.33|||||TWO_SIDED|90.0|1.13|1.56||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.56|1.13|
70932498|NCT00945321|141364547|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.04|||||TWO_SIDED|95.0|0.86|1.25||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.25|0.86|
70932499|NCT00945321|141364547|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.14|||||TWO_SIDED|90.0|0.96|1.34||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.34|0.96|
70932500|NCT00945321|141364547|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.4|||||TWO_SIDED|90.0|1.16|1.68||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.68|1.16|
70932501|NCT02866942|141364572|OTHER|||||||0.26|||||||McNemar|||||||0.26
70932502|NCT02568215|141364607|OTHER||Prevention Efficacy (PE)|8.8||||0.7|TWO_SIDED|95.0|-45.1|42.6||The threshold for statistical significance was p = 0.05.|wald|||The primary PE analysis tests the null hypothesis PE equal to zero versus the alternative hypothesis PE not equal to zero using a 2-sided alpha equal 0.05 level Wald test of the equality of log cumulative hazard functions at the week 80 visit for the pooled VRC01 group versus the placebo group.||42.6|-45.1|0.70
70932503|NCT02568215|141364607|OTHER||Prevention Efficacy (PE)|-9.3|||||TWO_SIDED|95.0|-85.3|35.5||||||A secondary analysis assesses the overall PE of the low-dose VRC01 group versus the placebo group.||35.5|-85.3|
70932504|NCT02568215|141364607|OTHER||Prevention Efficacy (PE)|27.0|||||TWO_SIDED|95.0|-30.7|59.3||||||A secondary analysis assesses the overall PE of the high-dose VRC01 group versus the placebo group.||59.3|-30.7|
71020665|NCT00782275|141548665|SUPERIORITY|||||||0.081|||||||exact binomial test|||The regimen was evaluated against an historical control with null and alternative 4-month PFS rates of 50% and 70%, respectively. With the final sample size of 40 eligible patients and using the same operating characteristics (alpha and beta 10%), the decision rule changes such that if 25 or more patients of 40 are alive and progression-free at 4 months then this regimen is considered promising.||||0.081
71020666|NCT00417027|141548698|SUPERIORITY_OR_OTHER||||||>|0.05||||||Bonferroni corrected for 6 comparisons|Wilcoxon (Mann-Whitney)|||||||>0.05
70932505|NCT02568215|141364609|OTHER||Prevention Efficacy (PE)|78.6|||||TWO_SIDED|95.0|17.3|94.4||||||PE against IC80 of least sensitive variant less than 1||94.4|17.3|
70932506|NCT02568215|141364609|OTHER||Prevention Efficacy (PE)|7.4|||||TWO_SIDED|95.0|-187.5|70.2||||||PE against IC80 of least sensitive variant 1-3||70.2|-187.5|
71020667|NCT00417027|141548698|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Bonferroni corrected for 6 comparisons|Wilcoxon (Mann-Whitney)|||||||0.005
71053245|NCT02304991|141610939|SUPERIORITY|||||||0.0005|||||||t-test, 2 sided|||Intent to treat; participants not completing the DBPCFC considered to have challenge score of zero||||0.0005
71020668|NCT00417027|141548698|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||Bonferroni corrected for 6 comparisons|Wilcoxon (Mann-Whitney)|||||||0.02
71020669|NCT00417027|141548699|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||Kruskal-Wallis|||||||0.54
71020670|NCT00417027|141548700|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Kruskal-Wallis|||||||0.32
71053246|NCT02304991|141610940|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||0.007
71020671|NCT00417027|141548701|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Kruskal-Wallis|||||||0.69
71053247|NCT02304991|141610941|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||Per protocol analysis of patients with available samples.||||0.01
71053248|NCT02304991|141610942|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Per protocol analysis of patients with available samples.||||<0.0001
70932507|NCT02568215|141364609|OTHER||Prevention Efficacy (PE)|-1.9|||||TWO_SIDED|95.0|-83.1|43.3||||||PE against IC80 of least sensitive variant \> 3||43.3|-83.1|
71020672|NCT00417027|141548702|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||Analysis applies to all rows.|Chi-squared, Corrected|||Analysis apply to all rows. Only 1 comparison was made between the groups in distribution of number of bolus doses.||||0.72
70932508|NCT00246805|141364615|SUPERIORITY_OR_OTHER||Proportions|48.0|||<|0.0001|TWO_SIDED|95.0|36.0|61.0|||Z-test for proportions|||VRS ON vs. VRS OFF||61|36|<0.0001
71020673|NCT00417027|141548703|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||Kruskal-Wallis|||||||0.41
71020674|NCT00417027|141548704|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Kruskal-Wallis|||||||0.85
71020675|NCT00386100|141548747|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49|||<|0.0001|TWO_SIDED|95.0|-0.669|-0.305||No adjustment for multiple comparisons|ANCOVA|ANCOVA with terms for treatment, region, gender, and baseline value with LOCF from Week 32 for withdrawn participants or missing values|AVM mean change from baseline minus MET mean change from baseline based on ANCOVA model|||-0.305|-0.669|<0.0001
71020676|NCT00386100|141548748|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.69|-0.3||No adjustment for multiple comparisons|Repeated measures analysis|Repeated measures analysis with terms for baseline, region, treatment, gender, time, and treatment by time interaction|AVM mean change from baseline minus MET mean change from baseline based on repeated measures analysis model|||-0.30|-0.69|<0.0001
71020677|NCT00386100|141548749|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.0046|TWO_SIDED|95.0|1.18|2.46||Hb1AC \<= 6.5%|Regression, Logistic|Logistic reggression with terms for treatment, region, gender, and baseline Hb1AC with LOCF from Week 32.|Odds of having an HbA1c \<= 6.5% at Week 80 on Avandamet compared to Metformin.|||2.46|1.18|0.0046
71020678|NCT00386100|141548749|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.59|||<|0.0001|TWO_SIDED|95.0|1.75|3.81||Hb1AC \< 7%|Regression, Logistic|Logistic reggression with terms for treatment, region, gender, and baseline Hb1AC with LOCF from Week 32|Odds of having an HbA1c \<7% at Week 80 on Avandamet compared to Metformin|||3.81|1.75|<0.0001
71053249|NCT02304991|141610943|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.3
71053250|NCT01770392|141610986|SUPERIORITY_OR_OTHER||Geometric Mean Ratio in percentage|50.12|STANDARD_DEVIATION|12.7||1|TWO_SIDED|90.0|47.155|53.275||p-value for ratio outside interval 0.8 - 1.25|ANOVA|"The model includes fixed effect for treatment and effect subjects was considered as random"|"The standard deviation is actually the geometric coefficient of variation (in %).~The ratio has been calculated as (nintedanib+ rifampicin) divided by nintedanib (in %)"|||53.275|47.155|1.0000
71020679|NCT00386100|141548750|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.15|||<|0.0001||95.0|-1.54|-0.77|||Repeated measures analysis|Terms for baseline, region, treatment, pre-screening Hb1Ac strata, gender, time, and treatment by time interaction|AVM mean change from baseline minus MET mean change from baseline based on repeated measures analysis model|||-0.77|-1.54|<0.0001
71020680|NCT00386100|141548751|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.07|||<|0.001|TWO_SIDED|95.0|-1.425|-0.71||No adjustment for multiple comparisons|ANCOVA|Terms for treatment, region, gender, pre-screening Hb1Ac strata, and baseline with LOCF from Week 32 for withdrawn participants or missing values|AVM mean change from baseline minus MET mean change from baseline based on ANCOVA model|||-0.710|-1.425|<0.001
71020681|NCT00386100|141548752|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.47|||<|0.0001|TWO_SIDED|95.0|2.94|6.81||FPG \<=6.1 mmol/l|Regression, Logistic|Terms for treatment, region, gender, pre-screening Hb1Ac strata, and baseline with LOCF from Week 32.|Odds of having an FPG \<=6.1 mmol/l at Week 80 on Avandamet compared to Metformin|||6.81|2.94|<0.0001
71020682|NCT00386100|141548752|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.33|||<|0.0001|TWO_SIDED|95.0|2.25|4.92||FPG \<=7 mmol/l|Regression, Logistic|Terms for treatment, region, gender, pre-screening Hb1Ac, and baseline with LOCF from Week 32.|Odds of having an FPG \<=7 mmol/l at Week 80 on Avandamet compared to Metformin|||4.92|2.25|<0.0001
71020683|NCT00386100|141548753|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.45|0.74|||Regression, Cox|Cox proportional hazard regression with terms for treatment, region, baseline Hb1Ac strata, and gender||||0.74|0.45|<0.0001
71020684|NCT00386100|141548754|SUPERIORITY_OR_OTHER||Percent difference from metformin|5.97||||0.0006|TWO_SIDED|95.0|2.522|9.526||Total cholesterol. No adjustment for multiple comparisons. Log transformed|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||9.526|2.522|0.0006
71020685|NCT00386100|141548754|SUPERIORITY_OR_OTHER||Percent difference from metformin|8.71||||0.056|TWO_SIDED|95.0|2.486|15.304||LDL cholesterol. No adjustment for multiple comparisons. Log transformed|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||15.304|2.486|0.056
71020686|NCT00386100|141548754|SUPERIORITY_OR_OTHER||Percent difference from metformin|2.58||||0.072|TWO_SIDED|95.0|-0.232|5.47||HDL cholesterol. No adjustment for multiple comparison. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||5.470|-0.232|0.072
71020687|NCT00386100|141548754|SUPERIORITY_OR_OTHER||Percent difference from metformin|0.743||||0.835|TWO_SIDED|95.0|-6.056|8.035||Triglycerides. No adjustment for multiple comparisons. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||8.035|-6.056|0.835
71053251|NCT01770392|141610987|SUPERIORITY_OR_OTHER||Geometric Mean Ratio in percentage|59.76|STANDARD_DEVIATION|21.9||1|TWO_SIDED|90.0|53.829|66.348||p-value for ratio outside interval 0.8 - 1.25|ANOVA|"The model includes fixed effect for treatment and effect subjects was considered as random"|"The standard deviation is actually the geometric coefficient of variation (in %).~The ratio has been calculated as (nintedanib+ rifampicin) divided by nintedanib (in %)."|||66.348|53.829|1.0000
70932509|NCT00174252|141364631|SUPERIORITY_OR_OTHER||Percentage|86.0|||||TWO_SIDED|95.0|74.2|93.7|||||95% CI was estimated using the F-distribution.|"Applies to no."||93.7|74.2|
71020688|NCT00386100|141548755|SUPERIORITY_OR_OTHER||Percent difference from metformin|102.24|||<|0.0001|TWO_SIDED|95.0|79.23|128.19||No adjustment for multiple comparisons. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||128.19|79.23|<0.0001
70932510|NCT00174252|141364631|SUPERIORITY_OR_OTHER||Percentage|14.0||||||95.0|6.3|25.8|||||95% confidence interval (CI) was estimated using the F-distribution.|"Applies to yes."||25.8|6.3|
71020689|NCT00386100|141548756|SUPERIORITY_OR_OTHER||Percent difference from metformin|-8.2||||0.138|TWO_SIDED|95.0|-18.04|2.82||No adjustment for multiple comparisons. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||2.82|-18.04|0.1380
71020690|NCT00386100|141548757|SUPERIORITY_OR_OTHER||Percent difference from metformin|-11.308||||0.0342|TWO_SIDED|95.0|-20.617|-0.899||No adjustment for multiple comparisons. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||-0.899|-20.617|0.0342
71053252|NCT01770392|141610988|SUPERIORITY_OR_OTHER||Geometric Mean Ratio in percentage|49.98|STANDARD_DEVIATION|13.3||1|TWO_SIDED|90.0|46.886|53.286||p-value for ratio outside interval 0.8 - 1.25|ANOVA|"The model includes fixed effect for treatment and effect subjects was considered as random"|"The standard deviation is actually the geometric coefficient of variation (in %).~The ratio has been calculated as (nintedanib+ rifampicin) divided by nintedanib (in %)."|||53.286|46.886|1.0000
71053253|NCT01193127|141611014|SUPERIORITY_OR_OTHER||least-squares mean difference|0.9|STANDARD_ERROR_OF_MEAN|0.1||0||95.0|0.6|1.1||Repeated measures model includes treatment (OMS302, ketorolac tromethamine, and vehicle), time-point and LOCS II grade as covariates|repeated measures model|All data time points collected used in the analysis.|OMS302 - Vehicle (BSS)|||1.1|0.6|0.0000
71053254|NCT01193127|141611014|SUPERIORITY_OR_OTHER||least-squares mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.1||0||95.0|0.5|0.9||Repeated measures model includes treatment (OMS302, ketorolac tromethamine, and vehicle), time-point and LOCS II grade as covariates.|repeated measures model|OMS302 - ketorolac tromethamine||||0.9|0.5|0.0000
71053255|NCT01193127|141611015|SUPERIORITY_OR_OTHER||least-squares mean difference|-4.6|STANDARD_ERROR_OF_MEAN|2.2||0.0421||95.0|-8.9|-0.2||Repeated measures model includes treatment (OMS302, PE and vehicle), time point and LOCS II grade as covariates|repeated measures model||OMS302 - Vehicle (BSS)|||-0.2|-8.9|0.0421
71053256|NCT01193127|141611015|SUPERIORITY_OR_OTHER||least-squares mean difference|-5.9|STANDARD_ERROR_OF_MEAN|2.2||0.0093||95.0|-10.3|-1.5||Repeated measures model includes treatment (OMS302, PE and vehicle), time point and LOCS II grade as covariates.|repeated measures model||OMS302 - PE|||-1.5|-10.3|0.0093
71053257|NCT01193127|141611016|SUPERIORITY_OR_OTHER|||||||0.63||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.630
71053258|NCT01193127|141611016|SUPERIORITY_OR_OTHER|||||||0.769||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.769
71053259|NCT01193127|141611016|SUPERIORITY_OR_OTHER|||||||0.025||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.025
71053260|NCT01193127|141611017|SUPERIORITY_OR_OTHER|||||||0.229||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.229
71053261|NCT01193127|141611017|SUPERIORITY_OR_OTHER|||||||0.162||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.162
71053262|NCT01193127|141611017|SUPERIORITY_OR_OTHER|||||||0.226||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.226
71053263|NCT01193127|141611018|SUPERIORITY_OR_OTHER|||||||0.177||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.177
71053264|NCT01193127|141611018|SUPERIORITY_OR_OTHER|||||||0.051||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.051
71053265|NCT01193127|141611018|SUPERIORITY_OR_OTHER|||||||0.497||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.497
71020691|NCT00386100|141548758|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-33.7||||0.0042|TWO_SIDED|95.0|-56.666|-0.99||No adjustment for multiple comparisons.|ANCOVA|ANCOVA with terms for treatment, region, gender, pre-screening HbA1c strata, and baseline.|AVM mean change from baseline minus MET mean change from baseline based on ANCOVA model|||-0.99|-56.666|0.0042
71053266|NCT01193127|141611019|SUPERIORITY_OR_OTHER|||||||0.48||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.480
71053267|NCT01193127|141611019|SUPERIORITY_OR_OTHER|||||||0.09||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.090
71053268|NCT01193127|141611019|SUPERIORITY_OR_OTHER|||||||0.439||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.439
71053269|NCT01193127|141611020|SUPERIORITY_OR_OTHER|||||||0.812||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.812
71053270|NCT01193127|141611020|SUPERIORITY_OR_OTHER|||||||0.48||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.480
71053271|NCT01193127|141611020|SUPERIORITY_OR_OTHER|||||||0.16||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.160
71106343|NCT00945659|141719684|SUPERIORITY||Mean Difference (Net)|-0.003|STANDARD_DEVIATION|0.2||0.86|TWO_SIDED|95.0|-0.43|0.36|||Generalized Estimating Equation|||||0.36|-0.43|0.86
70932511|NCT00174252|141364645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35||||0.002||95.0|||||ANCOVA|Adjusted for height SD at baseline.||||||0.002
71106344|NCT00945659|141719684|SUPERIORITY||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|0.19||0.03|TWO_SIDED|95.0|-0.78|-0.04|||Generalized Estimating Equation|||||-0.04|-0.78|0.03
71020692|NCT00386100|141548759|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.229||||0.0006|TWO_SIDED|95.0|-0.359|-0.099||No adjustment for multiple comparisons.|ANCOVA|ANCOVA with terms for treatment, region, gender, pre-screening HbA1c strata, and baseline|AVM mean change from baseline minus MET mean change from baseline based on ANCOVA model|||-0.099|-0.359|0.0006
71020693|NCT00386100|141548760|SUPERIORITY_OR_OTHER||Percent difference from metformin|2.4||||0.7148|TWO_SIDED|95.0|-9.87|16.34||HOMA-B. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||16.34|-9.87|0.7148
71020694|NCT00386100|141548760|SUPERIORITY_OR_OTHER||percent difference from metformin|31.14|||<|0.001|TWO_SIDED|95.0|14.82|49.78||HOMA-S. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||49.78|14.82|<0.001
71020695|NCT00386100|141548761|SUPERIORITY_OR_OTHER||Mean Difference (Net)|80.85||||0.319|TWO_SIDED|95.0|-79.035|240.744|||Repeated measures analysis|Repeated measures analysis with terms for baseline, region, treatment, gender, pre-screening Hb1AC, time, and treatment by time interaction||||240.744|-79.035|0.319
71020696|NCT00386100|141548763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2||||0.0012|TWO_SIDED|95.0|-3.5|-0.9||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.9|-3.5|0.0012
71020697|NCT00386100|141548763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.0031|TWO_SIDED|95.0|-2.7|-0.6||Overall population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.6|-2.7|0.0031
71020698|NCT00386100|141548763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1||||0.0308|TWO_SIDED|95.0|-2.0|-0.1||Overall population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.1|-2.0|0.0308
71053272|NCT01193127|141611021|SUPERIORITY_OR_OTHER|||||||0.085||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.085
71053273|NCT01193127|141611021|SUPERIORITY_OR_OTHER|||||||0.742||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.742
71020699|NCT00386100|141548763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.0954|TWO_SIDED|95.0|-3.7|0.3||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.3|-3.7|0.0954
71020700|NCT00386100|141548763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9||||0.0015|TWO_SIDED|95.0|-4.7|-1.2||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-1.2|-4.7|0.0015
71020701|NCT00386100|141548763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3||||0.0045|TWO_SIDED|95.0|-3.9|-0.7||Female population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.7|-3.9|0.0045
71020702|NCT00386100|141548763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2||||0.0005|TWO_SIDED|95.0|-3.3|-1.0||Female population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-1.0|-3.3|0.0005
71020703|NCT00386100|141548763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.2363|TWO_SIDED|95.0|-4.6|1.2||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.2|-4.6|0.2363
71020704|NCT00386100|141548763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3||||0.0161|TWO_SIDED|95.0|-5.9|-0.6||Postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.6|-5.9|0.0161
71053274|NCT01193127|141611021|SUPERIORITY_OR_OTHER|||||||0.021||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.021
71053275|NCT01193127|141611022|SUPERIORITY_OR_OTHER|||||||0.081||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.081
71053276|NCT01193127|141611022|SUPERIORITY_OR_OTHER|||||||0.202||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.202
71106345|NCT00945659|141719685|SUPERIORITY||Mean Difference (Net)|-10.05|STANDARD_DEVIATION|4.72||0.03|TWO_SIDED|95.0|-19.3|-0.81|||Generalized Estimating Equation|||||-0.81|-19.30|0.03
71106346|NCT00945659|141719685|SUPERIORITY||Mean Difference (Net)|-0.82|STANDARD_DEVIATION|5.47||0.88|TWO_SIDED|95.0|-11.54|9.9|||Generalized Estimating Equation|||||9.9|-11.54|0.88
71106347|NCT00945659|141719686|SUPERIORITY||Generalized Estimating Equation|-3.45|STANDARD_DEVIATION|4.98||0.49|TWO_SIDED|95.0|-13.21|6.32|||Generalized Estimating Equation|||||6.32|-13.21|0.49
70932512|NCT00174252|141364646|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35||||0.023||95.0||||Bilateral test multiple comparison threshold for statistical significance = 0.05|ANCOVA|Adjusted for height SD at baseline.||||||0.023
70932513|NCT00174252|141364647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.708||95.0|||||ANCOVA|Adjusted for height SD at baseline.||||||0.708
70932514|NCT00174252|141364648|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59||||0.325||95.0|||||ANCOVA|Adjusted for height SD at baseline.||||||0.325
70932515|NCT03170882|141364656|SUPERIORITY||Hazard Ratio (HR)|0.847|||=|0.477|TWO_SIDED|95.0|0.535|1.341|||Log Rank||HR obtained by unadjusted Cox's proportional hazard regression model stratified by age,international staging system(ISS),prior lines of therapy. HR\<1 was deemed to indicate better PFS in Ixazomib+Dexamethasone arm over Pomalidomide+Dexamethasone arm.|||1.341|0.535|=0.477
70932516|NCT03170882|141364657|SUPERIORITY||Hazard Ratio (HR)|1.427|||=|0.265|TWO_SIDED|95.0|0.761|2.677|||Log Rank||HR obtained by unadjusted Cox's proportional hazard regression model stratified by age, ISS and prior lines of therapy. HR \<1 was deemed to indicate longer survival time in Ixazomib + Dexamethasone arm as compared to Pomalidomide + Dexamethasone arm.|||2.677|0.761|=0.265
70932517|NCT03170882|141364658|SUPERIORITY||Odds Ratio (OR)|0.9|||=|0.634|TWO_SIDED|95.0|0.43|1.9|||Cochran-Mantel-Haenszel||OR was based on logistic regression model with treatment group as categorical predictor variable and age, ISS and prior lines of therapy. OR \>1 was deemed to indicate better response in Ixazomib+Dexamethasone arm over Pomalidomide+Dexamethasone arm.|||1.90|0.43|=0.634
70932518|NCT03170882|141364660|SUPERIORITY||Hazard Ratio (HR)|0.556|||||TWO_SIDED|95.0|0.288|1.073|||||HR was obtained by unadjusted Cox's proportional hazard regression model stratified by age, ISS, prior lines of therapy. HR \>1 was deemed to indicate quicker response time in Ixazomib + Dexamethasone arm over Pomalidomide + Dexamethasone arm.|||1.073|0.288|
70932519|NCT03170882|141364661|SUPERIORITY||Hazard Ratio (HR)|0.83|||=|0.459|TWO_SIDED|95.0|0.506|1.361|||Log Rank||HR: obtained by unadjusted Cox's proportional hazard regression model stratified by age,ISS,prior lines of therapy. HR\<1 was deemed to indicate better disease progression prevention in Ixazomib+Dexamethasone arm over Pomalidomide+Dexamethasone arm.|||1.361|0.506|=0.459
70932520|NCT03802994|141364669|EQUIVALENCE|Differences between groups were compared using the paired t test|||||<|0.05|TWO_SIDED|80.0|||||t-test, 2 sided|||Differences between groups were compared using the paired t test||||<0.05
71053277|NCT01193127|141611022|SUPERIORITY_OR_OTHER|||||||0.606||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.606
71053278|NCT01193127|141611023|SUPERIORITY_OR_OTHER|||||||0.893||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.893
71053279|NCT01193127|141611023|SUPERIORITY_OR_OTHER|||||||0.553||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.553
71053280|NCT01193127|141611023|SUPERIORITY_OR_OTHER|||||||0.412||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.412
71053281|NCT01193127|141611024|SUPERIORITY_OR_OTHER|||||||0.186||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.186
71053282|NCT01193127|141611024|SUPERIORITY_OR_OTHER|||||||0.191||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.191
70932521|NCT03802994|141364669|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70932522|NCT03802994|141364669|SUPERIORITY||||||<|0.05|TWO_SIDED|80.0|||||t-test, 2 sided|||||||<0.05
70932523|NCT03802994|141364670|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70932524|NCT03802994|141364670|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70932525|NCT03802994|141364671|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70932526|NCT03802994|141364672|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70932527|NCT02392234|141364687|SUPERIORITY||Least Squares (LS) Mean Difference|4.7|||<|0.0001|TWO_SIDED|95.0|3.7|5.8|||Linear Mixed Effects Model|||||5.8|3.7|< 0.0001
70932528|NCT02392234|141364687|SUPERIORITY||LS Mean Difference|6.8|||<|0.0001|TWO_SIDED|95.0|5.7|7.8|||Linear Mixed Effects Model|||||7.8|5.7|< 0.0001
70932529|NCT02392234|141364688|SUPERIORITY||LS Mean Difference|9.7|||<|0.0001|TWO_SIDED|95.0|7.2|12.2|||Linear Mixed Effects Model|||||12.2|7.2|<0.0001
70932530|NCT02392234|141364688|SUPERIORITY||LS Mean Difference|11.1|||<|0.0001|TWO_SIDED|95.0|8.7|13.6|||Linear Mixed Effects Model|||||13.6|8.7|<0.0001
70932531|NCT02392234|141364690|SUPERIORITY||LS Mean Difference|8.1|||<|0.0001|TWO_SIDED|95.0|6.3|9.9|||Linear Mixed Effects Model|||||9.9|6.3|<0.0001
70932532|NCT02392234|141364690|SUPERIORITY||LS Mean Difference|11.4|||<|0.0001|TWO_SIDED|95.0|9.6|13.2|||Linear Mixed Effects Model|||||13.2|9.6|<0.0001
70932533|NCT02392234|141364691|SUPERIORITY||LS Mean Difference|-4.5|||<|0.0001|TWO_SIDED|95.0|-6.7|-2.3|||Linear Mixed Effects Model|||||-2.3|-6.7|<0.0001
70932534|NCT02392234|141364691|SUPERIORITY||LS Mean Difference|-9.5|||<|0.0001|TWO_SIDED|95.0|-11.7|-7.3|||Linear Mixed Effects Model|||||-7.3|-11.7|<0.0001
70932535|NCT02029235|141364694|OTHER|||||||0.24|||||||t-test, 2 sided|||"Null hypothesis: No difference between groups~Power analysis: A sample size of 16 in each group had an 80% power to detect a difference in means of 10 mm."||||0.24
70932536|NCT02029235|141364695|OTHER|||||||0.06|||||||t-test, 2 sided|||Null hypothesis: No difference between groups||||0.06
70932537|NCT04066075|141364702|SUPERIORITY|||||||0.73||||||The p-value represents the difference between telerehabilitation and usual care.|Multilevel linear regression model|||Multilevel modeling in linear regression analyses accounted for within-patient correlations for the 3 assessments at baseline, 1-month and 4-months. Rasch analysis using the method of successive dichotomizations was applied to estimate person measures. Power calculation: a matched pairs t-test revealed 18 subjects per group would detect a within-subject mean improvement of 0.14-logits with 0.17-logits standard deviation for the differences, 0.80 power and 0.05 type 1 error probability.||||0.73
70932538|NCT01855750|141364740|SUPERIORITY||Hazard Ratio (HR)|0.922||||0.5167|TWO_SIDED|95.0|0.72|1.18|||Log Rank|||||1.180|0.720|0.5167
71020705|NCT00386100|141548763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6||||0.0338|TWO_SIDED|95.0|-4.9|-0.2||Postmenopausal female population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.2|-4.9|0.0338
71020706|NCT00386100|141548763|SUPERIORITY_OR_OTHER||Median Difference (Net)|-2.6||||0.002|TWO_SIDED|95.0|-4.1|-1.0||Postmenopausal female population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-1.0|-4.1|0.0020
71020707|NCT00386100|141548764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.0005|TWO_SIDED|95.0|-2.3|-0.7||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.7|-2.3|0.0005
71020708|NCT00386100|141548764|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.0||||0.011|TWO_SIDED|95.0|-1.7|-0.2||Overall population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.2|-1.7|0.0110
71020709|NCT00386100|141548764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.0618|TWO_SIDED|95.0|-1.1|0.0||Overall population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.0|-1.1|0.0618
71020710|NCT00386100|141548764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.011|TWO_SIDED|95.0|-2.3|-0.3||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.3|-2.3|0.0110
71020711|NCT00386100|141548764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.0272|TWO_SIDED|95.0|-1.9|-0.1||Male population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.1|-1.9|0.0272
71020712|NCT00386100|141548764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.0337|TWO_SIDED|95.0|-1.6|-0.1||Male population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.1|-1.6|0.0337
71020713|NCT00386100|141548764|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.7||||0.0152|TWO_SIDED|95.0|-3.1|-0.3||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.3|-3.1|0.0152
70932539|NCT01855750|141364741|SUPERIORITY||Hazard Ratio (HR)|0.949||||0.7311|TWO_SIDED|95.0|0.704|1.279|||Log Rank|||||1.279|0.704|0.7311
71020714|NCT00386100|141548764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.057|TWO_SIDED|95.0|-2.4|0.0||Female population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.0|-2.4|0.0570
71020715|NCT00386100|141548764|SUPERIORITY_OR_OTHER||Median Difference (Net)|-2.2||||0.0296|TWO_SIDED|95.0|-4.3|-0.2||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.2|-4.3|0.0296
71020716|NCT00386100|141548764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4||||0.0155|TWO_SIDED|95.0|-4.4|-0.5||Premenopausal female population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.5|-4.4|0.0155
71020717|NCT00386100|141548764|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.4||||0.587|TWO_SIDED|95.0|-1.7|1.0||Premenopausal female population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.0|-1.7|0.5870
71020718|NCT00386100|141548764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.1854|TWO_SIDED|95.0|-3.6|0.7||Postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.7|-3.6|0.1854
71020719|NCT00386100|141548765|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.9||||0.0038|TWO_SIDED|95.0|-3.2|-0.6||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.6|-3.2|0.0038
71053283|NCT01193127|141611024|SUPERIORITY_OR_OTHER|||||||0.167||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.167
71053284|NCT01193127|141611025|SUPERIORITY_OR_OTHER|||||||0.663||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.663
71106348|NCT00945659|141719686|SUPERIORITY||Mean Difference (Net)|2.53|STANDARD_DEVIATION|5.76||0.66|TWO_SIDED|95.0|||||Generalized Estimating Equation|||||||0.66
70932540|NCT01855750|141364742|SUPERIORITY||Hazard Ratio (HR)|0.917||||0.5027|TWO_SIDED|95.0|0.71|1.183|||Log Rank|||||1.183|0.710|0.5027
70932541|NCT01855750|141364743|SUPERIORITY||Odds Ratio (OR)|0.967||||0.8229|TWO_SIDED|95.0|0.722|1.296|||Cochran-Mantel-Haenszel (CMH) Chi-square|||||1.296|0.722|0.8229
70932542|NCT01855750|141364744|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.8549|TWO_SIDED|95.0|0.754|1.407|||Log Rank|||||1.407|0.754|0.8549
70932543|NCT01855750|141364745|SUPERIORITY||Hazard Ratio (HR)|1.358||||0.0021|TWO_SIDED|95.0|1.115|1.654|||Log Rank|||||1.654|1.115|0.0021
70932544|NCT05890794|141364771|OTHER|The difference in dose group means (0.8 mg/kg - 3.2 mg/kg) was calculated.|Mean Difference (Final Values)|40.85||||0.0005|TWO_SIDED|95.0|22.842|58.858||Significant test: 2-sided; significance level 5%.|t-test, 2 sided|A 2-sided t-test was carried out to determine whether there is a difference in means between the 0.8 mg/kg and 3.2 mg/kg dose groups.||Analysis of the difference in relative maximum change from baseline between dose groups of ilofotase alfa by a 2-sided t-test for PPi.||58.858|22.842|0.0005
70932545|NCT05890794|141364771|OTHER|The difference between LS Means of change from baseline between dose groups was calculated. The analysis was performed using an MMRM model with fixed effects for baseline value, dose group, timepoint, interaction between dose group and timepoint, as well as random effects for patient and error|Difference in LS Means|-11.17|STANDARD_ERROR_OF_MEAN|2.681|<|0.0001|TWO_SIDED|95.0|-16.52|-5.82||Significant test: 2-sided; significance level 5%.|Mixed Models Analysis|||Analysis of the difference in relative maximum change from baseline (LS Means) between dose groups of ilofotase alfa by a mixed model repeated measures (MMRM) analysis for PPi.||-5.82|-16.52|<0.0001
71053285|NCT01193127|141611025|SUPERIORITY_OR_OTHER|||||||0.326||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.326
71053286|NCT01193127|141611025|SUPERIORITY_OR_OTHER|||||||0.045||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.045
70932546|NCT05890794|141364772|OTHER|The difference in dose group means (0.8 mg/kg - 3.2 mg/kg) was calculated.|Mean Difference (Final Values)|30.89|||<|0.0001|TWO_SIDED|95.0|20.831|40.941||Significant test: 2-sided; significance level 5%.|t-test, 2 sided|A 2-sided t-test was carried out to determine whether there is a difference in means between the 0.8 mg/kg and 3.2 mg/kg dose groups.||Analysis of the difference in relative maximum change from baseline between dose groups of ilofotase alfa by a 2-sided t-test for PLP.||40.941|20.831|<0.0001
70932547|NCT05890794|141364772|OTHER|The difference between LS Means of change from baseline between dose groups was calculated. The analysis was performed using an MMRM model with fixed effects for baseline value, dose group, timepoint, interaction between dose group and timepoint, as well as random effects for patient and error.|Difference in LS Means|-22.51|STANDARD_ERROR_OF_MEAN|6.289||0.0024|TWO_SIDED|95.0|-35.81|-9.2||Significant test: two-sided; significance level 5%.|Mixed Models Analysis|||Analysis of the difference in relative maximum change from baseline (LS Means) between dose groups of ilofotase alfa by an MMRM analysis for PLP.||-9.20|-35.81|0.0024
70932548|NCT05890794|141364773|OTHER|The difference in dose group means (0.8 mg/kg - 3.2 mg/kg) was calculated.|Mean Difference (Final Values)|-4335.66||||0.0019|TWO_SIDED|95.0|-6652.753|-2018.576||Significant test: 2-sided; significance level 5%.|t-test, 2 sided|A 2-sided t-test was carried out to determine whether there is a difference in means between the 0.8 mg/kg and 3.2 mg/kg dose groups.||Analysis of the difference in relative maximum change from baseline between dose groups of ilofotase alfa by a 2-sided t-test for ALP activity.||-2018.576|-6652.753|0.0019
71020720|NCT00386100|141548765|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.0134|TWO_SIDED|95.0|-2.7|-0.3||Overall population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.3|-2.7|0.0134
71020721|NCT00386100|141548765|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.7||||0.0967|TWO_SIDED|95.0|-1.5|0.1||Overall population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.1|-1.5|0.0967
71020722|NCT00386100|141548765|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.0512|TWO_SIDED|95.0|-3.0|0.0||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.0|-3.0|0.0512
71020723|NCT00386100|141548765|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4||||0.033|TWO_SIDED|95.0|-4.6|-0.2||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.2|-4.6|0.0330
71020724|NCT00386100|141548765|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8||||0.0547|TWO_SIDED|95.0|-3.7|0.0||Female population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.0|-3.7|0.0547
71053287|NCT01193127|141611026|SUPERIORITY_OR_OTHER|||||||0.106||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.106
71053288|NCT01193127|141611026|SUPERIORITY_OR_OTHER|||||||0.519||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.519
71053289|NCT01193127|141611026|SUPERIORITY_OR_OTHER|||||||0.039||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.039
70932549|NCT05890794|141364774|OTHER|The difference in dose group means (0.8 mg/kg - 3.2 mg/kg) was calculated.|Mean Difference (Final Values)|23.25||||0.0693|TWO_SIDED|95.0|-2.319|48.812||Significant test: 2-sided; significance level 5%.|t-test, 2 sided|A 2-sided t-test was carried out to determine whether there is a difference in means between the 0.8 mg/kg and 3.2 mg/kg dose groups.||Analysis of the difference in relative maximum change from baseline between dose groups of ilofotase alfa by a 2-sided t-test for urine PEA.||48.812|-2.319|0.0693
70932550|NCT05890794|141364774|OTHER|The difference between LS Means of change from baseline between dose groups was calculated. The analysis was performed using an MMRM model with fixed effects for baseline value, dose group, timepoint, interaction between dose group and timepoint, as well as random effects for patient and error.|Difference in LS Means|-8.76|STANDARD_ERROR_OF_MEAN|22.986||0.7086|TWO_SIDED|95.0|-57.88|40.35||Significant test: 2-sided; significance level 5%.|Mixed Models Analysis|||Analysis of the difference in relative maximum change from baseline (LS Means) between dose groups of ilofotase alfa by an MMRM analysis for urine PEA.||40.35|-57.88|0.7086
71020725|NCT00386100|141548765|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.1||||0.0613|TWO_SIDED|95.0|-6.3|0.2||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.2|-6.3|0.0613
71020726|NCT00386100|141548765|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.5||||0.1369|TWO_SIDED|95.0|-3.9|1.7||Postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.7|-3.9|0.1369
71020727|NCT00386100|141548766|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.7||||0.126|TWO_SIDED|95.0|-1.7|0.2||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.2|-1.7|0.1260
71020728|NCT00386100|141548766|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.7||||0.3117|TWO_SIDED|95.0|-2.2|0.7||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.7|-2.2|0.3117
71020729|NCT00386100|141548766|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.1776|TWO_SIDED|95.0|-2.2|0.4||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.4|-2.2|0.1776
71020730|NCT00386100|141548766|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.2||||0.2259|TWO_SIDED|95.0|-3.2|0.8||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.8|-3.2|0.2259
71020731|NCT00386100|141548766|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.384|TWO_SIDED|95.0|-2.8|1.1||postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.1|-2.8|0.3840
70932551|NCT05890794|141364775|OTHER|The difference in dose group means (0.8 mg/kg - 3.2 mg/kg) was calculated.|Mean Difference (Final Values)|187.43||||0.0199|TWO_SIDED|95.0|36.516|338.344||Significant test: 2-sided; significance level 5%.|t-test, 2 sided|A 2-sided t-test was carried out to determine whether there is a difference in means between the 0.8 mg/kg and 3.2 mg/kg dose groups.||Analysis of the difference in relative maximum change from baseline between dose groups of ilofotase alfa by a 2-sided t-test for PL.||338.344|36.516|0.0199
70932552|NCT05890794|141364775|OTHER|The difference between LS Means of change from baseline between dose groups was calculated. The analysis was performed using an MMRM model with fixed effects for baseline value, dose group, timepoint, interaction between dose group and timepoint, as well as random effects for patient and error.|Difference in LS Means|-12.51|STANDARD_ERROR_OF_MEAN|9.767||0.2034|TWO_SIDED|95.0|-31.92|6.89||Significant test: 2-sided; significance level 5%|Mixed Models Analysis|||Analysis of the difference in relative maximum change from baseline (LS Means) between dose groups of ilofotase alfa by an MMRM analysis for PL.||6.89|-31.92|0.2034
70932553|NCT05890794|141364776|OTHER|The difference in dose group means (0.8 mg/kg - 3.2 mg/kg) was calculated.|Mean Difference (Final Values)|-0.89||||0.5195|TWO_SIDED|95.0|-3.868|2.084||Significant test: 2-sided; significance level 5%.|t-test, 2 sided|A 2-sided t-test was carried out to determine whether there is a difference in means between the 0.8 mg/kg and 3.2 mg/kg dose groups.||Analysis of the difference in fold change from baseline between dose groups of ilofotase alfa by a 2-sided t-test for PL/PLP ratio.||2.084|-3.868|0.5195
70932554|NCT05890794|141364776|OTHER|The difference between LS Means of fold change from baseline between dose groups was calculated. The analysis was performed using an MMRM model with fixed effects for baseline value, dose group, timepoint, interaction between dose group and timepoint, as well as random effects for patient and error.|Difference in LS Means|1.01|STANDARD_ERROR_OF_MEAN|0.161|<|0.0001|TWO_SIDED|95.0|0.69|1.33||Significant test: 2-sided; significance level 5%.|Mixed Models Analysis|||Analysis of the difference in fold change form baseline (LS Means) between dose levels of ilofotase alfa by an MMRM analysis for PL/PLP ratio.||1.33|0.69|<0.0001
70932555|NCT03516942|141364815|EQUIVALENCE|No margin of equivalence|Slope|0.0||||0.74|TWO_SIDED|95.0|-0.1|0.2||P value: For the categorical variable with more than 2 levels, this is the p value from the overall test of the null hypothesis that all estimates are equal against the alternative that at least one is different.|Regression, Linear|||"Age covariate effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equal"||0.2|-0.1|0.74
70941625|NCT04748445|141383934|OTHER||Slope|1.248|STANDARD_ERROR_OF_MEAN|7.598||0.1029|TWO_SIDED|90.0|-1.072|2.507|||Mixed Models Analysis|||EE\_MFCC mean 07 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and estimated value it was 10\^-1. For dispersion value it was 10\^-2 and for lower limit it was 10\^-3).||2.507|-1.072|0.1029
71020732|NCT00386100|141548767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.6102|TWO_SIDED|95.0|-1.9|1.1||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.1|-1.9|0.6102
71020733|NCT00386100|141548767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.3445|TWO_SIDED|95.0|-2.9|1.0||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.0|-2.9|0.3445
71020734|NCT00386100|141548767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.9735|TWO_SIDED|95.0|-2.4|2.3||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||2.3|-2.4|0.9735
71020735|NCT00386100|141548767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4||||0.4861|TWO_SIDED|95.0|-5.8|2.9||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||2.9|-5.8|0.4861
71020736|NCT00386100|141548767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.877|TWO_SIDED|95.0|-3.5|4.0||Postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||4.0|-3.5|0.8770
71020737|NCT00386100|141548768|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.2||||0.7015|TWO_SIDED|95.0|-1.5|1.0||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.0|-1.5|0.7015
71020738|NCT00386100|141548768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.6767|TWO_SIDED|95.0|-0.7|1.0||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.0|-0.7|0.6767
71020739|NCT00386100|141548768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.4199|TWO_SIDED|95.0|-3.4|1.5||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.5|-3.4|0.4199
71020740|NCT00386100|141548768|SUPERIORITY_OR_OTHER||Median Difference (Net)|-5.5||||0.2526|TWO_SIDED|95.0|-16.4|5.4||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||5.4|-16.4|0.2526
71106349|NCT00945659|141719687|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_DEVIATION|0.86||0.64|TWO_SIDED|95.0|-1.29|2.08|||Generalized Estimating Equation|||||2.08|-1.29|0.64
71020741|NCT00386100|141548768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.4153|TWO_SIDED|95.0|-1.8|0.8||postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.8|-1.8|0.4153
71020742|NCT00386100|141548769|SUPERIORITY_OR_OTHER||Percent difference from metformin|0.168||||0.7895|TWO_SIDED|95.0|-1.066|1.417||Overall population, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||1.417|-1.066|0.7895
71020743|NCT00386100|141548769|SUPERIORITY_OR_OTHER||Percent difference from metformin|0.745||||0.4155|TWO_SIDED|95.0|-1.064|2.587||Males, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||2.587|-1.064|0.4155
71020744|NCT00386100|141548769|SUPERIORITY_OR_OTHER||Percent difference from metformin|-0.452||||0.6223|TWO_SIDED|95.0|-2.253|1.382||Females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||1.382|-2.253|0.6223
71020745|NCT00386100|141548769|SUPERIORITY_OR_OTHER||Percent difference from metformin|-0.638||||0.5908|TWO_SIDED|95.0|-3.043|1.826||Premenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||1.826|-3.043|0.5908
71106350|NCT00945659|141719687|SUPERIORITY||Mean Difference (Net)|-0.41|STANDARD_DEVIATION|0.92||0.65|TWO_SIDED|95.0|-2.22|1.39|||Generalized Estimating Equation|||||1.39|-2.22|0.65
70941626|NCT04748445|141383934|OTHER||Slope|-1.054|STANDARD_ERROR_OF_MEAN|7.218||0.1468|TWO_SIDED|90.0|-2.25|1.423|||Mixed Models Analysis|||EE\_MFCC mean 08 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit and estimated value it was 10\^-1. For upper limit and dispersion value it was 10\^-2).||1.423|-2.250|0.1468
71106351|NCT00945659|141719688|SUPERIORITY||Mean Difference (Net)|0.71|STANDARD_DEVIATION|63.4||0.99|TWO_SIDED|95.0|-123.56|124.97|||Generalized Estimating Equation|||||124.97|-123.56|0.99
71106352|NCT00945659|141719688|SUPERIORITY||Mean Difference (Net)|-1.22|STANDARD_DEVIATION|13.81||0.93|TWO_SIDED|95.0|-28.26|25.83|||Generalized Estimating Equation|||||25.83|-28.26|0.93
71053290|NCT01193127|141611027|SUPERIORITY_OR_OTHER|||||||0.1||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.100
71053291|NCT01193127|141611027|SUPERIORITY_OR_OTHER|||||||0.029||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.029
71053292|NCT01193127|141611027|SUPERIORITY_OR_OTHER|||||||0.525||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.525
71053293|NCT01193127|141611028|SUPERIORITY_OR_OTHER|||||||0.642||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.642
71053294|NCT01193127|141611028|SUPERIORITY_OR_OTHER|||||||0.442||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.442
70941627|NCT04748445|141383934|OTHER||Slope|0.05944|STANDARD_ERROR_OF_MEAN|6.536||0.3649|TWO_SIDED|90.0|-0.04887|0.1678|||Mixed Models Analysis|||EE\_MFCC mean 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1678|-0.04887|0.3649
71020746|NCT00386100|141548769|SUPERIORITY_OR_OTHER||Percent difference from metformin|-0.155||||0.9154|TWO_SIDED|95.0|-3.037|2.814||Postmenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||2.814|-3.037|0.9154
71020747|NCT00386100|141548770|SUPERIORITY_OR_OTHER||Percent difference from metformin|1.467||||0.8682|TWO_SIDED|95.0|-14.785|20.818||Overall population, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||20.818|-14.785|0.8682
71053295|NCT01193127|141611028|SUPERIORITY_OR_OTHER|||||||0.467||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.467
71053296|NCT01193127|141611029|SUPERIORITY_OR_OTHER|||||||0.695||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.695
71053297|NCT01193127|141611029|SUPERIORITY_OR_OTHER|||||||0.355||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.355
71053298|NCT01193127|141611029|SUPERIORITY_OR_OTHER|||||||0.369||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.369
71053299|NCT01193127|141611030|SUPERIORITY_OR_OTHER|||||||0.124||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.124
71053300|NCT01193127|141611030|SUPERIORITY_OR_OTHER|||||||0.298||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.298
71053301|NCT01193127|141611030|SUPERIORITY_OR_OTHER|||||||0.291||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.291
70941628|NCT04748445|141383934|OTHER||Slope|-0.03115|STANDARD_ERROR_OF_MEAN|6.007||0.605|TWO_SIDED|90.0|-0.1307|0.06839|||Mixed Models Analysis|||EE\_MFCC mean 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.06839|-0.1307|0.6050
71020748|NCT00386100|141548770|SUPERIORITY_OR_OTHER||Percent difference from metformin|0.328||||0.974|TWO_SIDED|95.0|-18.308|23.214||Males, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||23.214|-18.308|0.9740
71053302|NCT01193127|141611031|SUPERIORITY_OR_OTHER|||||||0.825||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.825
71053303|NCT01193127|141611031|SUPERIORITY_OR_OTHER|||||||0.211||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.211
71053304|NCT01193127|141611031|SUPERIORITY_OR_OTHER|||||||0.589||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.589
71053305|NCT01193127|141611032|SUPERIORITY_OR_OTHER|||||||0.401||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.401
71053306|NCT01193127|141611032|SUPERIORITY_OR_OTHER|||||||0.2||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Chi-squared, Corrected|||||||0.200
71053307|NCT01193127|141611032|SUPERIORITY_OR_OTHER|||||||0.478||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.478
71053308|NCT01193127|141611033|SUPERIORITY_OR_OTHER|||||||0.758||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.758
71053309|NCT01193127|141611033|SUPERIORITY_OR_OTHER|||||||0.521||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.521
71020749|NCT00386100|141548770|SUPERIORITY_OR_OTHER||Percent difference from metformin|2.986||||0.8378|TWO_SIDED|95.0|-22.997|37.735||Females, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||37.735|-22.997|0.8378
71053310|NCT01193127|141611033|SUPERIORITY_OR_OTHER|||||||0.432||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.432
71053311|NCT01193127|141611034|SUPERIORITY_OR_OTHER|||||||0.148||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.148
71020750|NCT00386100|141548770|SUPERIORITY_OR_OTHER||Percent difference from metformin|8.19||||0.7889|TWO_SIDED|95.0|-43.839|108.422||Pre-menopausal females, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||108.422|-43.839|0.7889
71020751|NCT00386100|141548770|SUPERIORITY_OR_OTHER||Percent difference from metformin|3.344||||0.88|TWO_SIDED|95.0|-34.853|63.935||Postmenopausal females, Week 80. Log transformed.|ANCOVA|.Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||63.935|-34.853|0.8800
71020752|NCT00386100|141548771|SUPERIORITY_OR_OTHER||Percent difference from metformin|1.2168||||0.9069|TWO_SIDED|95.0|-17.6057|24.3392||Overall population, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||24.3392|-17.6057|0.9069
71020753|NCT00386100|141548771|SUPERIORITY_OR_OTHER||Percent difference from metformin|-10.1648||||0.5118|TWO_SIDED|95.0|-35.6298|25.3742||Males, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||25.3742|-35.6298|0.5118
71020754|NCT00386100|141548771|SUPERIORITY_OR_OTHER||Percent difference from metformin|8.8777||||0.5816|TWO_SIDED|95.0|-20.2636|48.6692||Females, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||48.6692|-20.2636|0.5816
71020755|NCT00386100|141548771|SUPERIORITY_OR_OTHER||Percent difference from metformin|-1.0031||||0.9587|TWO_SIDED|95.0|-35.928|52.959||Pre-menopausal females, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||52.9590|-35.9280|0.9587
71020756|NCT00386100|141548771|SUPERIORITY_OR_OTHER||Percent difference from metformin|4.7614||||0.8337|TWO_SIDED|95.0|-34.4741|67.4901||Postmenopausal females, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||67.4901|-34.4741|0.8337
71020757|NCT00386100|141548772|SUPERIORITY_OR_OTHER||Percent difference from metformin|7.527||||0.7041|TWO_SIDED|95.0|-26.773|57.892||Females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||57.892|-26.773|0.7041
71020758|NCT00386100|141548772|SUPERIORITY_OR_OTHER||Percent difference from metformin|30.211||||0.6403|TWO_SIDED|95.0|-61.586|341.371||Pre-menopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||341.371|-61.586|0.6403
71053312|NCT01193127|141611034|SUPERIORITY_OR_OTHER|||||||0.156||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.156
71053313|NCT01193127|141611034|SUPERIORITY_OR_OTHER|||||||0.381||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.381
71053314|NCT01193127|141611035|SUPERIORITY_OR_OTHER|||||||0.646||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.646
71053315|NCT01193127|141611035|SUPERIORITY_OR_OTHER|||||||0.95||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.950
71053316|NCT01193127|141611035|SUPERIORITY_OR_OTHER|||||||0.16||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.160
71106353|NCT00945659|141719689|SUPERIORITY||Mean Difference (Net)|1.17|STANDARD_DEVIATION|1.47||0.43|TWO_SIDED|95.0|-1.7|4.04|||Generalized Estimating Equation|||||4.04|-1.70|0.43
71106354|NCT00945659|141719689|SUPERIORITY||Mean Difference (Net)|-2.59|STANDARD_DEVIATION|1.87||0.08|TWO_SIDED|95.0|-5.5|0.32|||Generalized Estimating Equation|||||0.32|-5.50|0.08
71106355|NCT00945659|141719690|SUPERIORITY||Mean Difference (Net)|1.32|STANDARD_DEVIATION|1.66||0.43|TWO_SIDED|95.0|-1.94|4.56|||Generalized Estimating Equation|||||4.56|-1.94|0.43
71106356|NCT00945659|141719690|SUPERIORITY||Mean Difference (Net)|-3.71|STANDARD_DEVIATION|1.36||0.007|TWO_SIDED|95.0|-6.38|-1.04|||Generalized Estimating Equation|||||-1.04|-6.38|.007
71106357|NCT00945659|141719691|SUPERIORITY||Mean Difference (Net)|0.39|STANDARD_DEVIATION|1.23||0.75|TWO_SIDED|95.0|-2.02|2.79|||Generalized Estimating Equation|||||2.79|-2.02|0.75
71106358|NCT00945659|141719691|SUPERIORITY||Mean Difference (Net)|-0.39|STANDARD_DEVIATION|1.38||0.78|TWO_SIDED|95.0|-3.09|2.32|||Generalized Estimating Equation|||||2.32|-3.09|0.78
71106359|NCT00945659|141719692|SUPERIORITY||Mean Difference (Net)|0.72|STANDARD_DEVIATION|1.31||0.58|TWO_SIDED|95.0|-1.86|3.29|||Generalized Estimating Equation|||||3.29|-1.86|0.58
71106360|NCT00945659|141719692|SUPERIORITY||Mean Difference (Net)|-0.93|STANDARD_DEVIATION|1.14||0.41|TWO_SIDED|95.0|-3.17|1.3|||Generalized Estimating Equation|||||1.3|-3.17|0.41
71106361|NCT00945659|141719693|SUPERIORITY||Mean Difference (Net)|1.95|STANDARD_DEVIATION|2.66||0.46|TWO_SIDED|95.0|-3.26|7.15|||Generalized Estimating Equation|||||7.15|-3.26|0.46
71106362|NCT00945659|141719693|SUPERIORITY||Mean Difference (Net)|-3.01|STANDARD_DEVIATION|2.54||0.24|TWO_SIDED|95.0|-7.99|1.96|||Generalized Estimating Equation|||||1.96|-7.99|0.24
71106363|NCT00945659|141719694|SUPERIORITY||Mean Difference (Net)|0.31|STANDARD_DEVIATION|3.37||0.93|TWO_SIDED|95.0|-6.33|6.91|||Generalized Estimating Equation|||||6.91|-6.33|0.93
71106364|NCT00945659|141719694|SUPERIORITY||Mean Difference (Net)|-2.21|STANDARD_DEVIATION|2.95||0.45|TWO_SIDED|95.0|-8.01|3.57|||Generalized Estimating Equation|||||3.57|-8.01|0.45
71106365|NCT00945659|141719695|SUPERIORITY||Mean Difference (Net)|-0.77|STANDARD_DEVIATION|3.26||0.81|TWO_SIDED|95.0|-7.15|5.62|||Generalized Estimating Equestion|||||5.62|-7.15|0.81
70941629|NCT04748445|141383934|OTHER||Slope|-0.01908|STANDARD_ERROR_OF_MEAN|5.932||0.7483|TWO_SIDED|90.0|-0.1174|0.07922|||Mixed Models Analysis|||EE\_MFCC mean 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.07922|-0.1174|0.7483
71106366|NCT00945659|141719695|SUPERIORITY||Mean Difference (Net)|0.99|STANDARD_DEVIATION|2.63||0.72|TWO_SIDED|95.0|-4.11|6.08|||Generalized Estimating Equation|||||6.08|-4.11|0.72
71106367|NCT00945659|141719696|SUPERIORITY||Mean Difference (Net)|0.99|STANDARD_DEVIATION|2.6||0.71|TWO_SIDED|95.0|-4.11|6.08|||Generalized Estimating Equation|||||6.08|-4.11|0.71
71106368|NCT00945659|141719696|SUPERIORITY||Mean Difference (Net)|-1.16|STANDARD_DEVIATION|2.85||0.68|TWO_SIDED|95.0|-6.74|4.43|||Generalized Estimating Equation|||||4.43|-6.74|0.68
71106369|NCT04562116|141719697|OTHER||Ratio|94.59||||0.5789|TWO_SIDED|90.0|79.57|112.45||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Caffeine||112.45|79.57|0.5789
71106370|NCT04562116|141719697|OTHER||Ratio|99.34||||0.9468|TWO_SIDED|90.0|83.66|117.96||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Metoprolol Tartrate||117.96|83.66|0.9468
71106371|NCT04562116|141719697|OTHER||Ratio|107.81||||0.1364|TWO_SIDED|90.0|99.14|117.24||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Midazolam||117.24|99.14|0.1364
71106372|NCT04562116|141719697|OTHER||Ratio|92.13||||0.1915|TWO_SIDED|90.0|82.85|102.44||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Omeprazole||102.44|82.85|0.1915
71106373|NCT04562116|141719697|OTHER||Ratio|101.67||||0.5059|TWO_SIDED|90.0|97.41|106.12||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Warfarin Sodium||106.12|97.41|0.5059
71106374|NCT04562116|141719698|OTHER||Ratio|95.82||||0.6665|TWO_SIDED|90.0|80.72|113.75||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Caffeine||113.75|80.72|0.6665
71106375|NCT04562116|141719698|OTHER||Ratio|99.15||||0.9316|TWO_SIDED|90.0|83.43|117.83||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Metoprolol Tartrate||117.83|83.43|0.9316
71106376|NCT04562116|141719698|OTHER||Ratio|107.75||||0.1371|TWO_SIDED|90.0|99.12|117.13||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Midazolam||117.13|99.12|0.1371
71106377|NCT04562116|141719698|OTHER||Ratio|88.66||||0.0962|TWO_SIDED|90.0|78.72|99.85||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Omeprazole||99.85|78.72|0.0962
70851327|NCT00669409|141190546|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.2|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-24.7|6.4||||||Change at Week 1, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.4|-24.7|
71106378|NCT04562116|141719698|OTHER||Ratio|100.81||||0.6807|TWO_SIDED|90.0|97.45|104.29||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Warfarin Sodium||104.29|97.45|0.6807
71106379|NCT04562116|141719699|OTHER||Ratio|91.22||||0.3431|TWO_SIDED|90.0|77.3|107.63||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Caffeine||107.63|77.30|0.3431
71106380|NCT04562116|141719699|OTHER||Ratio|91.05||||0.4277|TWO_SIDED|90.0|74.33|111.53||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Metoprolol Tartrate||111.53|74.33|0.4277
71106381|NCT04562116|141719699|OTHER||Ratio|94.79||||0.4963|TWO_SIDED|90.0|82.8|108.52||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Midazolam||108.52|82.80|0.4963
71106382|NCT04562116|141719699|OTHER||Ratio|88.24||||0.1931|TWO_SIDED|90.0|75.08|103.7||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Omeprazole||103.70|75.08|0.1931
71106383|NCT04562116|141719699|OTHER||Ratio|92.94||||0.296|TWO_SIDED|90.0|82.51|104.69||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Warfarin Sodium||104.69|82.51|0.2960
71106384|NCT00934921|141719710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|97.1||||||90.0|91.2|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|91.2|
71106385|NCT00934921|141719711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|95.2||||||90.0|88.8|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102|88.8|
71020759|NCT00386100|141548772|SUPERIORITY_OR_OTHER||Percent difference from metformin|1.929||||0.8474|TWO_SIDED|95.0|-17.015|25.198||Postmenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|.Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||25.198|-17.015|0.8474
71020760|NCT00386100|141548773|SUPERIORITY_OR_OTHER||Percent difference from metformin|5.7||||0.486|TWO_SIDED|95.0|-9.6|23.6||Overall, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||23.6|-9.6|0.4860
71020761|NCT00386100|141548773|SUPERIORITY_OR_OTHER||Percent difference from metformin|12.3||||0.3791|TWO_SIDED|95.0|-13.7|46.1||Males, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||46.1|-13.7|0.3791
71053317|NCT01193127|141611036|SUPERIORITY_OR_OTHER|||||||1||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||1.000
71020762|NCT00386100|141548773|SUPERIORITY_OR_OTHER||Percent difference from metformin|4.0||||0.7065|TWO_SIDED|95.0|-15.3|27.6||Females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||27.6|-15.3|0.7065
71053318|NCT01193127|141611036|SUPERIORITY_OR_OTHER|||||||0.667||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.667
71053319|NCT01193127|141611036|SUPERIORITY_OR_OTHER|||||||0.303||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.303
70851328|NCT00669409|141190546|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-20.4|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-36.0|-4.9||||||Change at Week 1, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-4.9|-36.0|
71053320|NCT01193127|141611037|SUPERIORITY_OR_OTHER|||||||0.789||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.789
70932556|NCT03516942|141364815|EQUIVALENCE|No margin of equivalence|Slope|-0.4|||<|0.001|TWO_SIDED|95.0|-0.6|-0.3||P value: For the categorical variable with more than 2 levels, this is the p value from the overall test of the null hypothesis that all estimates are equal against the alternative that at least one is different.|Regression, Linear|||"Baseline COST effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equal"||-0.3|-0.6|<0.001
71020763|NCT00386100|141548773|SUPERIORITY_OR_OTHER||Percent difference from metformin|32.1||||0.1381|TWO_SIDED|95.0|-9.5|92.7||Pre-menopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||92.7|-9.5|0.1381
71020764|NCT00386100|141548773|SUPERIORITY_OR_OTHER||Percent difference from metformin|-4.3||||0.7195|TWO_SIDED|95.0|-25.4|22.7||Postmenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|.Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||22.7|-25.4|0.7195
71020765|NCT00386100|141548774|SUPERIORITY_OR_OTHER||Percent difference from metformin|-3.0||||0.5595|TWO_SIDED|95.0|-12.3|7.4||Overall, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||7.4|-12.3|0.5595
71020766|NCT00386100|141548774|SUPERIORITY_OR_OTHER||Percent difference from metformin|1.0||||0.9125|TWO_SIDED|95.0|-15.3|20.4||Males, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||20.4|-15.3|0.9125
71020767|NCT00386100|141548774|SUPERIORITY_OR_OTHER||Percent difference from metformin|-0.8||||0.9122|TWO_SIDED|95.0|-14.0|14.5||Females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||14.5|-14.0|0.9122
71106386|NCT00934921|141719712|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|95.9||||||90.0|89.5|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|89.5|
71020768|NCT00386100|141548774|SUPERIORITY_OR_OTHER||Percent difference from metformin|4.6||||0.7435|TWO_SIDED|95.0|-21.2|38.7||Pre-menopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||38.7|-21.2|0.7435
71020769|NCT00386100|141548774|SUPERIORITY_OR_OTHER||Percent difference from metformin|-7.5||||0.3897|TWO_SIDED|95.0|-23.0|11.0||Postmenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|.Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||11.0|-23.0|0.3897
71020770|NCT00386100|141548775|SUPERIORITY_OR_OTHER||Percent difference from metformin|-2.83||||0.5176|TWO_SIDED|95.0|-10.97|6.06||Overall, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||6.06|-10.97|0.5176
71020771|NCT00386100|141548775|SUPERIORITY_OR_OTHER||Percent difference from metformin|-6.26||||0.362|TWO_SIDED|95.0|-18.62|7.97||Males, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||7.97|-18.62|0.3620
71020772|NCT00386100|141548775|SUPERIORITY_OR_OTHER||Percent difference from metformin|0.72||||0.9115|TWO_SIDED|95.0|-11.39|14.48||Females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||14.48|-11.39|0.9115
71020773|NCT00386100|141548775|SUPERIORITY_OR_OTHER||Percent difference from metformin|-13.51||||0.1956|TWO_SIDED|95.0|-30.35|8.31||Pre-menopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||8.31|-30.35|0.1956
71020774|NCT00386100|141548775|SUPERIORITY_OR_OTHER||Percent difference from metformin|3.75||||0.6749|TWO_SIDED|95.0|-13.09|23.85||Postmenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|.Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||23.85|-13.09|0.6749
71106387|NCT00833521|141719734|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|91.1||||||90.0|86.3|96.1|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||96.1|86.3|
71106388|NCT00833521|141719735|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|97.0||||||90.0|91.0|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|91.0|
70851329|NCT00669409|141190546|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|7.92|||TWO_SIDED|95.0|-19.9|11.4||||||Change at Week 1, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.4|-19.9|
70932557|NCT03516942|141364815|EQUIVALENCE|No margin of equivalence||||||0.002||||||This is the p value of the null hypothesis that COST estimates for all cancer types (Colon cancer, Rectal cancer and Rectosigmoid) are equal against the alternative that at least one is different.|Regression, Linear|||"Cancer type (Colon cancer, Rectal cancer and Rectosigmoid) effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equal"||||0.002
71053321|NCT01193127|141611037|SUPERIORITY_OR_OTHER|||||||0.977||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.977
71053322|NCT01193127|141611037|SUPERIORITY_OR_OTHER|||||||0.336||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.336
71053323|NCT01193127|141611038|SUPERIORITY_OR_OTHER|||||||0.632||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.632
70932558|NCT03516942|141364815|EQUIVALENCE|No margin of equivalence|Slope|0.3||||0.03|TWO_SIDED|95.0|0.0|0.6|||Regression, Linear|||"FACT-G7 effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equal"||0.6|0.0|0.03
70932559|NCT03516942|141364815|EQUIVALENCE|No margin of equivalence|Slope|1.6||||0.13|TWO_SIDED|95.0|-0.5|3.7|||Regression, Linear|||"Gender effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equal"||3.7|-0.5|0.13
71053324|NCT01193127|141611038|SUPERIORITY_OR_OTHER|||||||0.778||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.778
71053325|NCT01193127|141611038|SUPERIORITY_OR_OTHER|||||||0.336||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.336
71053326|NCT01193127|141611039|SUPERIORITY_OR_OTHER|||||||0.528||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.528
71053327|NCT01193127|141611039|SUPERIORITY_OR_OTHER|||||||0.362||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.362
71053328|NCT01193127|141611039|SUPERIORITY_OR_OTHER|||||||0.353||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.353
71053329|NCT01193127|141611040|SUPERIORITY_OR_OTHER|||||||0.463||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.463
71053330|NCT01193127|141611040|SUPERIORITY_OR_OTHER|||||||0.406||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.406
71053331|NCT01193127|141611040|SUPERIORITY_OR_OTHER|||||||0.245||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.245
71053332|NCT01193127|141611041|SUPERIORITY_OR_OTHER|||||||0.945||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.945
71053333|NCT01193127|141611041|SUPERIORITY_OR_OTHER|||||||0.438||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.438
71053334|NCT01193127|141611041|SUPERIORITY_OR_OTHER|||||||0.596||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.596
71053335|NCT01193127|141611042|SUPERIORITY_OR_OTHER|||||||0.811||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.811
71053336|NCT01193127|141611042|SUPERIORITY_OR_OTHER|||||||0.552||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.552
71053337|NCT01193127|141611042|SUPERIORITY_OR_OTHER|||||||0.549||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.549
71053338|NCT01193127|141611043|SUPERIORITY_OR_OTHER|||||||0.173||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.173
71053339|NCT01193127|141611043|SUPERIORITY_OR_OTHER|||||||0.362||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.362
71053340|NCT01193127|141611043|SUPERIORITY_OR_OTHER|||||||0.559|||||||Cochran-Mantel-Haenszel|||||||0.559
71053341|NCT01193127|141611044|SUPERIORITY_OR_OTHER|||||||0.681||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.681
71053342|NCT01193127|141611044|SUPERIORITY_OR_OTHER|||||||0.429||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.429
70932560|NCT03516942|141364815|EQUIVALENCE|No margin of equivalence||||||0.91||||||This is the p value of the null hypothesis that COST estimates for all RACES (White, Black, other) are equal against the alternative that at least one is different.|Regression, Linear|||"RACE (White. Black Other) effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equal"||||0.91
70932561|NCT03516942|141364815|EQUIVALENCE|No margin of equivalence|Slope|0.0|||>|0.99|TWO_SIDED|95.0|-0.3|0.3|||Regression, Linear|||"Neighborhood Deprivation (NDI) effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Higher NDI = greater neighborhood deprivation"||0.3|-0.3|>0.99
70932562|NCT03516942|141364817|EQUIVALENCE|no margin||||||0.4142||||||alpha=0.05|McNemar|||Work Time Missed from Baseline to 6 Months||||0.4142
70932563|NCT03516942|141364817|EQUIVALENCE|no margin||||||0.1797|||||||McNemar|||Impairment of Activities at Work from Baseline to 6 Months||||0.1797
71020775|NCT02020785|141548776|SUPERIORITY|Main analyses were intention-to-treat using mixed effects models allowing intercepts to vary for each individual. Carryover effects were examined by using treatment by assignment-order interaction terms. Pre-specified sensitivity analyses were conducted excluding patients who were non-compliant, prior to data analysis: 1st, noncompliance based on missing product pickups and follow-up visits; 2nd, suspected poor compliance (\< 250 mg difference between the higher and lower period).\]|Mean Difference (Final Values)|0.143||||0.05|TWO_SIDED|95.0|-0.025|0.34||For each outcome, a p value \< 0.05 was considered statistically significant without adjustment for multiple comparisons.|Mixed Models Analysis||Estimate (14.3%, 95% CI: -2.5%, 34.0%) is the estimated difference between end of higher phosphorus period and end of lower phosphorus period from mixed effects analyses for log-transformed 24-hour urine albumin excretion|Sample size for this study was calculated using the xsampsi module in STATA, based on a previous study with repeat 24-hour urine collections (standard deviation, 1.04). At an α level of 0.05, we anticipated that a sample size of 30 participants with mean albuminuria of 100 mg/d would result in \>80% power to detect a 13% difference in log- transformed albuminuria between the higher and lower phosphorus additive periods.||0.34|-0.025|0.05
71020776|NCT02020785|141548777|SUPERIORITY||Mean Difference (Final Values)|0.034||||0.05|TWO_SIDED|95.0|-0.059|0.136||For each outcome, a p value \< 0.05 was considered statistically significant without adjustment for multiple comparisons.|Mixed Models Analysis||Estimate (3.4%, 95% CI: -5.9%, 13.6%) is the estimated difference between end of higher phosphorus period and end of lower phosphorus period from mixed effects analyses for log-transformed fibroblast growth factor 23|||0.136|-0.059|0.05
71020777|NCT02020785|141548778|SUPERIORITY||mean difference (during each period)|-1.1||||0.05|TWO_SIDED|95.0|-4.1|1.9||For each outcome, a p value \< 0.05 was considered statistically significant without adjustment for multiple comparisons.|Mixed Models Analysis|||||1.9|-4.1|0.05
71020778|NCT02020785|141548779|SUPERIORITY||mean difference (during each period)|-0.8||||0.05|TWO_SIDED|95.0|-2.7|1.0||For each outcome, a p value \< 0.05 was considered statistically significant without adjustment for multiple comparisons.|Mixed Models Analysis|||||1.0|-2.7|0.05
71020779|NCT02328807|141548780|OTHER||Negative biopsy rate at 6 months after R|0.667|||||TWO_SIDED|95.0|0.223|0.957|||||Two-sided exact confidence interval was calculated using Clopper-Pearson method.|This trail is a single cohort study and no statistical hypothesis test for the primary outcome was planned.||0.957|0.223|
71020780|NCT00701935|141548808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|4.432||0.8252|TWO_SIDED|95.0|-9.92|7.95||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline abdominal visceral fat.||"The power calculation is based on a two-sided t-test and significance level of 0.05.~Hypotheses for sample size:~Power: 80% Drop-out rate: 20% Difference in the percentage change in abdominal visceral fat from baseline to 6 months between exenatide and placebo: 10% Common standard deviation: 15%~94 patients are needed to attain the 37 patients randomized and analyzed in each group."||7.95|-9.92|0.8252
71020781|NCT00701935|141548809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.07|STANDARD_ERROR_OF_MEAN|3.193||0.5207|TWO_SIDED|95.0|-8.53|4.39||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline total abdominal fat.||||4.39|-8.53|0.5207
71020782|NCT00701935|141548810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.71|STANDARD_ERROR_OF_MEAN|2.687||0.1755|TWO_SIDED|95.0|-9.15|1.73||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline subcutaneous abdominal fat.||||1.73|-9.15|0.1755
71053343|NCT01193127|141611044|SUPERIORITY_OR_OTHER|||||||0.306||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.306
71053344|NCT01193127|141611045|SUPERIORITY_OR_OTHER|||||||0.226||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.226
71053345|NCT01193127|141611045|SUPERIORITY_OR_OTHER|||||||0.602||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.602
71053346|NCT01193127|141611045|SUPERIORITY_OR_OTHER|||||||0.29|||||||Cochran-Mantel-Haenszel|||||||0.290
71053347|NCT01193127|141611046|SUPERIORITY_OR_OTHER|||||||0.244||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.244
70932564|NCT03516942|141364817|EQUIVALENCE|no margin||||||0.8415|||||||McNemar|||Overall Work Impairment from Baseline to 6 Months||||0.8415
70932565|NCT03516942|141364817|EQUIVALENCE|no margin||||||0.6831|||||||McNemar|||Impairment of Activities Outside of Work from Baseline to 6 Months||||0.6831
70932566|NCT03516942|141364817|EQUIVALENCE|no margin|||||<|0.0001|||||||McNemar|||Work Time Missed from Baseline to 12 Months||||<.0001
70932567|NCT03516942|141364817|EQUIVALENCE|no margin||||||0.0455|||||||McNemar|||Impairment of Activities at Work from Baseline to 12 Months||||0.0455
71053348|NCT01193127|141611046|SUPERIORITY_OR_OTHER|||||||0.122||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.122
70932568|NCT03516942|141364817|EQUIVALENCE|no margin|||||<|0.0001|||||||McNemar|||Overall Work Impairment from Baseline to 12 Months||||<.0001
70932569|NCT03516942|141364817|EQUIVALENCE|no margin||||||0.0164|||||||McNemar|||3 Impairment of Activities Outside of Work from Baseline to 12 Months||||0.0164
70932570|NCT03516942|141364817|EQUIVALENCE|nomargin||||||0.0027|||||||McNemar|||Work Time Missed from Baseline to 24 Months||||0.0027
71053349|NCT01193127|141611046|SUPERIORITY_OR_OTHER|||||||0.79||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.790
71053350|NCT01193127|141611047|SUPERIORITY_OR_OTHER|||||||0.752||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.752
71053351|NCT01193127|141611047|SUPERIORITY_OR_OTHER|||||||0.355||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.355
71053352|NCT01193127|141611047|SUPERIORITY_OR_OTHER|||||||0.292||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.292
71053353|NCT01193127|141611048|SUPERIORITY_OR_OTHER|||||||0.228||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.228
71053354|NCT01193127|141611048|SUPERIORITY_OR_OTHER|||||||0.564||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.564
71053355|NCT01193127|141611048|SUPERIORITY_OR_OTHER|||||||0.755||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.755
71053356|NCT01193127|141611049|SUPERIORITY_OR_OTHER|||||||0.018||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.018
71106389|NCT00833521|141719736|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|96.8||||||90.0|90.7|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|90.7|
71106390|NCT04549454|141719741|SUPERIORITY||Mean Difference (Final Values)|-0.011|STANDARD_ERROR_OF_MEAN|0.598||0.985|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on weekly drinks. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 1-month follow-up in the Intervention Arm versus the Control Arm.||||.985
71106391|NCT04549454|141719742|SUPERIORITY||Mean Difference (Final Values)|0.244|STANDARD_ERROR_OF_MEAN|0.618||0.694|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on weekly drinks. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 6-month follow-up in the Intervention Arm versus the Control Arm.||||.694
70851330|NCT00669409|141190546|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.7|STANDARD_ERROR_OF_MEAN|7.73|||TWO_SIDED|95.0|-30.9|-0.4||||||Change at Week 1, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-0.4|-30.9|
70932571|NCT03516942|141364817|EQUIVALENCE|no margin||||||0.0124|||||||McNemar|||Impairment of Activities at Work from Baseline to 24 Months||||0.0124
70932572|NCT03516942|141364817|EQUIVALENCE|no margin|||||<|0.0001|||||||McNemar|||Overall Work Impairment from Baseline to 24 Months||||<.0001
70932573|NCT03516942|141364817|EQUIVALENCE|no margin||||||0.0011|||||||McNemar|||Impairment of Activities Outside of Work from Baseline to 24 Months||||0.0011
70932574|NCT03516942|141364823|EQUIVALENCE|no equivalence margin was assumed||||||0.017|||||||McNemar|||the McNemar test was used to compare the results assuming a null of no difference.||||0.017
71053357|NCT01193127|141611049|SUPERIORITY_OR_OTHER|||||||0.292||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.292
71053358|NCT01193127|141611049|SUPERIORITY_OR_OTHER|||||||0.298||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.298
71053359|NCT01193127|141611050|SUPERIORITY_OR_OTHER|||||||0.271||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.271
71053360|NCT01193127|141611050|SUPERIORITY_OR_OTHER|||||||0.345||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.345
71053361|NCT01193127|141611050|SUPERIORITY_OR_OTHER|||||||0.096||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.096
71053362|NCT01193127|141611051|SUPERIORITY_OR_OTHER|||||||0.32||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.320
71053363|NCT01193127|141611051|SUPERIORITY_OR_OTHER|||||||0.39||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.390
71053364|NCT01193127|141611051|SUPERIORITY_OR_OTHER|||||||0.23||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.230
71053365|NCT01193127|141611052|SUPERIORITY_OR_OTHER|||||||0.778||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.778
71053366|NCT01193127|141611052|SUPERIORITY_OR_OTHER|||||||0.348||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.348
71053367|NCT01193127|141611052|SUPERIORITY_OR_OTHER|||||||0.477||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.477
71053368|NCT01193127|141611053|SUPERIORITY_OR_OTHER|||||||0.374||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.374
71053369|NCT01193127|141611053|SUPERIORITY_OR_OTHER|||||||0.265||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.265
71053370|NCT01193127|141611053|SUPERIORITY_OR_OTHER|||||||0.555||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.555
71053371|NCT01193127|141611054|SUPERIORITY_OR_OTHER|||||||0.031||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.031
71053372|NCT01193127|141611054|SUPERIORITY_OR_OTHER|||||||0.059||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.059
71053373|NCT01193127|141611054|SUPERIORITY_OR_OTHER|||||||0.472||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.472
71053374|NCT01193127|141611055|SUPERIORITY_OR_OTHER|||||||0.476||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.476
71053375|NCT01193127|141611055|SUPERIORITY_OR_OTHER|||||||0.169||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.169
71053376|NCT01193127|141611055|SUPERIORITY_OR_OTHER|||||||0.31||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.310
71053377|NCT01193127|141611056|SUPERIORITY_OR_OTHER|||||||0.075||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.075
71106392|NCT04549454|141719743|SUPERIORITY||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.327||0.889|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on consequences. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in consequences from baseline to the 1-month follow-up in the Intervention Arm versus the Control Arm.||||.889
71106393|NCT04549454|141719744|SUPERIORITY||Mean Difference (Final Values)|-0.186|STANDARD_ERROR_OF_MEAN|0.338||0.582|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on consequences. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in consequences from baseline to the 6-month follow-up in the Intervention Arm versus the Control Arm.||||.582
71106394|NCT04549454|141719745|SUPERIORITY||Mean Difference (Final Values)|-0.265|STANDARD_ERROR_OF_MEAN|0.414||0.523|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on peak drinks. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in peak drinks from baseline to the 1-month follow-up in the Intervention Arm versus the Control Arm.||||.523
71053378|NCT01193127|141611056|SUPERIORITY_OR_OTHER|||||||0.005||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.005
71053379|NCT01193127|141611056|SUPERIORITY_OR_OTHER|||||||0.078||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.078
71053380|NCT01193127|141611057|SUPERIORITY_OR_OTHER|||||||0.226||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.226
71053381|NCT01193127|141611057|SUPERIORITY_OR_OTHER|||||||0.357||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.357
71053382|NCT01193127|141611057|SUPERIORITY_OR_OTHER|||||||0.291||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.291
71053383|NCT01193127|141611058|SUPERIORITY_OR_OTHER|||||||0.172||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.172
71053384|NCT01193127|141611058|SUPERIORITY_OR_OTHER|||||||0.547||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.547
71106395|NCT04549454|141719746|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.427||0.981|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on peak drinks. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in peak drinks from baseline to the 6-month follow-up in the Intervention Arm versus the Control Arm.||||.981
71053385|NCT01193127|141611058|SUPERIORITY_OR_OTHER|||||||0.921||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wicoxon rank-sum test|||||||0.921
71053386|NCT01193127|141611059|SUPERIORITY_OR_OTHER|||||||0.701||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.701
71053387|NCT01193127|141611059|SUPERIORITY_OR_OTHER|||||||0.089||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.089
71053388|NCT01193127|141611059|SUPERIORITY_OR_OTHER|||||||0.095||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.095
71053389|NCT01193127|141611060|SUPERIORITY_OR_OTHER|||||||0.086||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.086
71053390|NCT01193127|141611060|SUPERIORITY_OR_OTHER|||||||0.092||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wicoxon rank-sum test|||||||0.092
71053391|NCT01193127|141611060|SUPERIORITY_OR_OTHER|||||||0.12||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.120
71053392|NCT01193127|141611061|SUPERIORITY_OR_OTHER|||||||0.626||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.626
71053393|NCT01193127|141611061|SUPERIORITY_OR_OTHER|||||||0.736||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.736
71053394|NCT01193127|141611061|SUPERIORITY_OR_OTHER|||||||0.725||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.725
71053395|NCT01193127|141611062|SUPERIORITY_OR_OTHER|||||||0.22||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.220
71106396|NCT04549454|141719747|SUPERIORITY||Median Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.327||0.889|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on HED. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in HED from baseline to the 1-month follow-up in the Intervention Arm versus the Control Arm.||||.889
71106397|NCT04549454|141719748|SUPERIORITY||Mean Difference (Final Values)|-0.186|STANDARD_ERROR_OF_MEAN|0.338||0.582|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on HED. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in HED from baseline to the 6-month follow-up in the Intervention Arm versus the Control Arm.||||.582
71106398|NCT01405196|141719767|SUPERIORITY||Odds Ratio (OR)|2.23||||0.076|TWO_SIDED|90.0|0.89|5.62||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||Point estimates of the Odds ratio (ORs) as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||5.62|0.89|0.076
70851331|NCT00669409|141190546|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-29.1|STANDARD_ERROR_OF_MEAN|10.25|||TWO_SIDED|95.0|-49.4|-8.9||||||Change at Week 1, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-8.9|-49.4|
71053396|NCT01193127|141611062|SUPERIORITY_OR_OTHER|||||||0.903||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.903
71053397|NCT01193127|141611062|SUPERIORITY_OR_OTHER|||||||0.463||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.463
71053398|NCT01193127|141611063|SUPERIORITY_OR_OTHER|||||||0.675||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.675
71053399|NCT01193127|141611063|SUPERIORITY_OR_OTHER|||||||0.825||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|WIlcoxon rank-sum test|||||||0.825
71053400|NCT01193127|141611063|SUPERIORITY_OR_OTHER|||||||0.668||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.668
71053401|NCT01193127|141611064|SUPERIORITY_OR_OTHER|||||||0.2066||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.2066
71053402|NCT01193127|141611064|SUPERIORITY_OR_OTHER|||||||0.2066||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.2066
71053403|NCT01193127|141611064|SUPERIORITY_OR_OTHER|||||||0.5263||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.5263
71053404|NCT01193127|141611065|SUPERIORITY_OR_OTHER|||||||0.4222||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.4222
71053405|NCT01193127|141611065|SUPERIORITY_OR_OTHER|||||||0.2712||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.2712
71053406|NCT01193127|141611065|SUPERIORITY_OR_OTHER|||||||0.8819||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.8819
71053407|NCT01193127|141611066|SUPERIORITY_OR_OTHER|||||||0.051||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.0510
71053408|NCT01193127|141611066|SUPERIORITY_OR_OTHER|||||||0.8084||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.8084
71053409|NCT01193127|141611066|SUPERIORITY_OR_OTHER|||||||0.1495||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.1495
71053410|NCT01193127|141611067|SUPERIORITY_OR_OTHER|||||||0.4099||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.4099
71053411|NCT01193127|141611067|SUPERIORITY_OR_OTHER|||||||0.6499||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.6499
71053412|NCT01193127|141611067|SUPERIORITY_OR_OTHER|||||||0.0765||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.0765
71053413|NCT01193127|141611068|SUPERIORITY_OR_OTHER|||||||0.0688||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.0688
71053414|NCT01193127|141611068|SUPERIORITY_OR_OTHER|||||||0.0314||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.0314
71053415|NCT01193127|141611068|SUPERIORITY_OR_OTHER|||||||0.0775||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.0775
71053416|NCT01193127|141611069|SUPERIORITY_OR_OTHER|||||||0.5369||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.5369
71053417|NCT01193127|141611069|SUPERIORITY_OR_OTHER|||||||0.3763||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.3763
71053418|NCT01193127|141611069|SUPERIORITY_OR_OTHER|||||||0.6144||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.6144
71053419|NCT01193127|141611070|SUPERIORITY_OR_OTHER|||||||0.1374||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.1374
71053420|NCT01193127|141611070|SUPERIORITY_OR_OTHER|||||||0.9146||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.9146
71053421|NCT01193127|141611070|SUPERIORITY_OR_OTHER|||||||0.7599||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.7599
71053422|NCT01193127|141611071|SUPERIORITY_OR_OTHER|||||||0.317||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.317
71053423|NCT01193127|141611071|SUPERIORITY_OR_OTHER|||||||0.317||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.317
71053424|NCT01193127|141611071|SUPERIORITY_OR_OTHER|||||||1||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||1.000
71053425|NCT01193127|141611072|SUPERIORITY_OR_OTHER|||||||0.559||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.559
71106399|NCT01405196|141719767|SUPERIORITY||Odds Ratio (OR)|0.96||||0.528|TWO_SIDED|90.0|0.38|2.41||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.41|0.38|0.528
71053426|NCT01193127|141611072|SUPERIORITY_OR_OTHER|||||||0.647||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.647
71053427|NCT01193127|141611072|SUPERIORITY_OR_OTHER|||||||0.559||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.559
71053428|NCT01193127|141611073|SUPERIORITY_OR_OTHER|||||||0.317||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.317
71053429|NCT01193127|141611073|SUPERIORITY_OR_OTHER|||||||0.335||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.335
71053430|NCT01193127|141611073|SUPERIORITY_OR_OTHER|||||||0.317||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.317
71053431|NCT01193127|141611074|SUPERIORITY_OR_OTHER|||||||1||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||1.000
71053432|NCT01193127|141611074|SUPERIORITY_OR_OTHER|||||||0.559||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.559
71053433|NCT01193127|141611074|SUPERIORITY_OR_OTHER|||||||1||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||1.000
71053434|NCT01193127|141611075|SUPERIORITY_OR_OTHER|||||||0.824||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.824
71053435|NCT01193127|141611075|SUPERIORITY_OR_OTHER|||||||0.476||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.476
71053436|NCT01193127|141611075|SUPERIORITY_OR_OTHER|||||||0.281||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.281
71106400|NCT01405196|141719768|SUPERIORITY||Odds Ratio (OR)|2.77|||||TWO_SIDED|90.0|0.62|12.4||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||12.40|0.62|
70932575|NCT00490139|141364827|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.048|TWO_SIDED|95.0|0.71|1.0|||Log Rank|Stratification was by chemotherapy timing, hormone receptor status, and axillary lymph node status.|The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.00|0.71|0.048
71106401|NCT01405196|141719768|SUPERIORITY||Odds Ratio (OR)|1.54|||||TWO_SIDED|90.0|0.31|7.71||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||7.71|0.31|
70941630|NCT04748445|141383934|OTHER||Slope|-6.574|STANDARD_ERROR_OF_MEAN|5.105||0.9897|TWO_SIDED|90.0|-8.526|8.394|||Mixed Models Analysis|||EE\_MFCC mean 12 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-2. For estimated value it was 10\^-4).||8.394|-8.526|0.9897
71053437|NCT01193127|141611076|SUPERIORITY_OR_OTHER|||||||0.842||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.842
71053438|NCT01193127|141611076|SUPERIORITY_OR_OTHER|||||||0.619||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.619
71053439|NCT01193127|141611076|SUPERIORITY_OR_OTHER|||||||0.711||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.711
71053440|NCT01193127|141611077|SUPERIORITY_OR_OTHER|||||||0.773||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.773
71053441|NCT01193127|141611077|SUPERIORITY_OR_OTHER|||||||0.592||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.592
71053442|NCT01193127|141611077|SUPERIORITY_OR_OTHER|||||||0.787||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.787
71053443|NCT01193127|141611078|SUPERIORITY_OR_OTHER|||||||0.695||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.695
71053444|NCT01193127|141611078|SUPERIORITY_OR_OTHER|||||||0.166||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.166
71053445|NCT01193127|141611078|SUPERIORITY_OR_OTHER|||||||0.987||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.987
71053446|NCT01193127|141611079|SUPERIORITY_OR_OTHER|||||||0.134||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.134
71053447|NCT01193127|141611079|SUPERIORITY_OR_OTHER|||||||0.71||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.710
71106402|NCT01405196|141719768|SUPERIORITY||Odds Ratio (OR)|1.03|||||TWO_SIDED|90.0|0.4|2.67||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.67|0.40|
71053448|NCT01193127|141611079|SUPERIORITY_OR_OTHER|||||||0.31||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.310
71053449|NCT01193127|141611080|SUPERIORITY_OR_OTHER|||||||0.086||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.086
71053450|NCT01193127|141611080|SUPERIORITY_OR_OTHER|||||||0.183||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.183
71053451|NCT01193127|141611080|SUPERIORITY_OR_OTHER|||||||0.029||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.029
71053452|NCT01193127|141611081|SUPERIORITY_OR_OTHER|||||||0.206||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.206
71053453|NCT01193127|141611081|SUPERIORITY_OR_OTHER|||||||0.021||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.021
71053454|NCT01193127|141611081|SUPERIORITY_OR_OTHER|||||||0.026||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.026
71053455|NCT01193127|141611082|SUPERIORITY_OR_OTHER|||||||0.822||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.822
71053456|NCT01193127|141611082|SUPERIORITY_OR_OTHER|||||||0.424||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.424
71053457|NCT01193127|141611082|SUPERIORITY_OR_OTHER|||||||0.695||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.695
71053458|NCT01193127|141611083|SUPERIORITY_OR_OTHER|||||||0.489||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.489
71053459|NCT01193127|141611083|SUPERIORITY_OR_OTHER|||||||0.459||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.459
71053460|NCT01193127|141611083|SUPERIORITY_OR_OTHER|||||||0.99||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.990
71053461|NCT01193127|141611085|SUPERIORITY_OR_OTHER|||||||0.4575||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.4575
71053462|NCT01193127|141611085|SUPERIORITY_OR_OTHER|||||||0.8318||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.8318
71053463|NCT01193127|141611085|SUPERIORITY_OR_OTHER|||||||0.8946||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.8946
71053464|NCT01193127|141611086|SUPERIORITY_OR_OTHER|||||||0.157||||||Ocular pain medications will be identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 will be presented. Treatment comparisons will be performed using methodology 1.|Cochran-Mantel-Haenszel|||||||0.1570
71053465|NCT01193127|141611086|SUPERIORITY_OR_OTHER|||||||0.0839||||||Ocular pain medications will be identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 will be presented. Treatment comparisons will be performed using methodology 1.|Cochran-Mantel-Haenszel|||||||0.0839
71106403|NCT01405196|141719768|SUPERIORITY||Odds Ratio (OR)|0.77|||||TWO_SIDED|90.0|0.29|2.05||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.05|0.29|
71106404|NCT01405196|141719768|SUPERIORITY||Odds Ratio (OR)|0.89|||||TWO_SIDED|90.0|0.35|2.24||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.24|0.35|
71106405|NCT01405196|141719768|SUPERIORITY||Odds Ratio (OR)|0.44|||||TWO_SIDED|90.0|0.16|1.16||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.16|0.16|
71053466|NCT01193127|141611086|SUPERIORITY_OR_OTHER|||||||0.092||||||Ocular pain medications will be identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 will be presented. Treatment comparisons will be performed using methodology 1.|Cochran-Mantel-Haenszel|||||||0.0920
71053467|NCT01193127|141611087|SUPERIORITY_OR_OTHER|||||||0.711||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.711
71053468|NCT01193127|141611087|SUPERIORITY_OR_OTHER|||||||0.253||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.253
71053469|NCT01193127|141611087|SUPERIORITY_OR_OTHER|||||||0.104||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.104
71053470|NCT03246646|141611090|SUPERIORITY||Z test of proportions|0.66|||>|0.05|ONE_SIDED||||||Z test of independent proportions|||||||>.05
71053471|NCT02569112|141611091|SUPERIORITY|A significant improvement in skin laxity reduction is defined as a mean average increase in grade of 1 as per the GAIS.|||||<|0.01|||||||Wilcoxon (Mann-Whitney)|Used Wilcoxon Matched-Pairs Signed-Ranks test||The null hypothesis was that the addition of the multipolar radiofrequency with varipulse technology treatment to the cryolipolysis treatment would not show visual improvement.||||<0.01
71053472|NCT02352779|141611092|OTHER||Mean Difference (Final Values)|0.6763|STANDARD_ERROR_OF_MEAN|0.4843||0.1666|TWO_SIDED||||||ANCOVA|Based on a contrast using the three-arm ANCOVA.||BFI-SF||||0.1666
71053473|NCT02352779|141611092|OTHER||Mean Difference (Final Values)|0.6936|STANDARD_ERROR_OF_MEAN|0.4567||0.1329|TWO_SIDED||||||ANCOVA|Based on a contrast using the three-arm ANCOVA.||BFI-SF||||0.1329
71053474|NCT02352779|141611092|OTHER||Mean Difference (Final Values)|0.0831|STANDARD_ERROR_OF_MEAN|3.8065||0.9826|TWO_SIDED||||||ANCOVA|Based on a contrast using the three-arm ANCOVA.||MFSI-SF||||0.9826
71053475|NCT02352779|141611092|OTHER||Mean Difference (Final Values)|2.9898|STANDARD_ERROR_OF_MEAN|3.5448||0.4016|TWO_SIDED||||||ANCOVA|Based on a contrast using the three-arm ANCOVA.||MFSI-SF||||0.4016
71053476|NCT01398943|141611093|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71020783|NCT00701935|141548811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|STANDARD_ERROR_OF_MEAN|0.155|<|0.0001|TWO_SIDED|95.0|-1.19|-0.57||p-values were not adjusted for multiple comparisons.|ANCOVA|ANCOVA analysis included the following factors: treatment, gender, investigator and baseline HbA1c||||-0.57|-1.19|<0.0001
71020784|NCT00701935|141548813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39|STANDARD_ERROR_OF_MEAN|0.491||0.0073|TWO_SIDED|95.0|-2.38|-0.4||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline fasting plasma glucose.||||-0.40|-2.38|0.0073
71020785|NCT00701935|141548814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.21|STANDARD_ERROR_OF_MEAN|0.725||0.0035|TWO_SIDED|95.0|-3.66|-0.76||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline body weight.||||-0.76|-3.66|0.0035
71020786|NCT00701935|141548817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.248||0.4145|TWO_SIDED|95.0|-0.71|0.3||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline total cholesterol||||0.30|-0.71|0.4145
71020787|NCT00701935|141548818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.279||0.4007|TWO_SIDED|95.0|-0.8|0.33||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline triglycerides||||0.33|-0.80|0.4007
71020788|NCT00701935|141548819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.048||0.7915|TWO_SIDED|95.0|-0.08|0.11||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline HDL cholesterol||||0.11|-0.08|0.7915
71020789|NCT00701935|141548820|SUPERIORITY_OR_OTHER||Ratio|3.28|STANDARD_ERROR_OF_MEAN|2.63||0.1388|TWO_SIDED|95.0|0.68|15.77||p-values were not adjusted for multiple comparisons.|Regression, Linear|Generalized linear model was used with the assumption of an underlying Poisson distribution and the logarithm of exposure (years) as offset variable.||Event rate per subject year was calculated for each subject : (number of events observed from a subject/exposure from a subject)\*365.25 where exposure = last post-baseline visit date - baseline visit date.||15.77|0.68|0.1388
71020790|NCT01783483|141548851|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Comparison of mean CT scan scores.||||<0.0001
71053477|NCT01398943|141611093|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
70932576|NCT00490139|141364827|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.96||||0.61|TWO_SIDED|95.0|0.81|1.13|||Log Rank|Stratification was by chemotherapy timing, hormone receptor status, and axillary lymph node status.|The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.13|0.81|0.610
71020791|NCT01783483|141548852|SUPERIORITY_OR_OTHER|||||||0.0007|||||||t-test, 2 sided|||||||0.0007
71020792|NCT01783483|141548853|SUPERIORITY_OR_OTHER|||||||0.0539|||||||t-test, 2 sided|||At Rest||||0.0539
71020793|NCT01783483|141548853|SUPERIORITY_OR_OTHER|||||||0.0015|||||||t-test, 2 sided|||After Forced Coughing||||0.0015
71020794|NCT01783483|141548854|SUPERIORITY_OR_OTHER|||||||0.2125|||||||t-test, 2 sided|||At Rest||||0.2125
71020795|NCT01783483|141548854|SUPERIORITY_OR_OTHER|||||||0.0014|||||||t-test, 2 sided|||After Forced Coughing||||0.0014
71020796|NCT01783483|141548855|SUPERIORITY_OR_OTHER|||||||0.0049|||||||t-test, 2 sided|||At Rest||||0.0049
71020797|NCT01783483|141548855|SUPERIORITY_OR_OTHER|||||||0.0183|||||||t-test, 2 sided|||After Forced Coughing||||0.0183
71020798|NCT01783483|141548856|SUPERIORITY_OR_OTHER|||||||0.6653|||||||t-test, 2 sided|||At Rest||||0.6653
71020799|NCT01783483|141548856|SUPERIORITY_OR_OTHER|||||||0.2295|||||||t-test, 2 sided|||After Forced Coughing||||0.2295
71020800|NCT01783483|141548858|SUPERIORITY_OR_OTHER|||||||0.37|||||||t-test, 2 sided|||Index (Day 0 to Hospital Discharge)||||0.370
71020801|NCT01783483|141548859|SUPERIORITY_OR_OTHER|||||||0.778|||||||t-test, 2 sided|||From Hospital Discharge to 3-week||||0.778
71020802|NCT01783483|141548860|SUPERIORITY_OR_OTHER|||||||0.055|||||||t-test, 2 sided|||From 3-week to 6-week post-op||||0.055
71020803|NCT01783483|141548862|SUPERIORITY_OR_OTHER|||||||0.113|||||||t-test, 2 sided|||From 3 month to 6-month post op||||0.113
71020804|NCT03398928|141548863|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71020805|NCT03398928|141548864|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
71020806|NCT03398928|141548867|SUPERIORITY|||||||0.002||||||The statistical analysis applies to all the rows|Chi-squared|||||||0.002
71020807|NCT03398928|141548868|SUPERIORITY|||||||0.253|||||||Wilcoxon (Mann-Whitney)|||||||0.253
71020808|NCT00370396|141548883|NON_INFERIORITY_OR_EQUIVALENCE|Standardized asymptotic 95% confidence interval (CI) for the difference \[Synflorix-Synflorix minus Prevenar-Prevenar\] in terms of percentages of subjects reporting rectal fever \>39.0°C was computed.|Difference in percentage|-4.43|||||TWO_SIDED|95.0|-11.85|-0.21||||||Analysis aimed at demonstrating the non-inferiority of Synflorix™ vs Prevenar™ vaccine, both co-administered with Infanrix hexa™ vaccine, in terms of post-immunization febrile reactions with rectal fever \> 39.0°C.||-0.21|-11.85|
71020809|NCT03567239|141548975|OTHER|"The PIADS is broken into 3 subgroups - Competence, Adaptability, and Self-Esteem. The minimum possible score is -3 and the maximum possible score is 3 for each subgroup - with positive 3 being the best. The 7-Point Likert scale was used in response to the question The device provided increased my ability to … in relation to the custom need they had. A response of 1 = Strongly disagree and 7 = strongly agree."|||||||||||||||||Median values: Overall = 2.42, Competence = 2.58, Adaptability = 2.33, Self-Esteem = 2.00, Likert = 7|||
71020810|NCT03567239|141548976|OTHER|||||||||||||||||The NASA Task Load Index ranges from 1 to 21 with the lower the score the better.|Median vales: Overall = 4.83, Mental demand = 11, Physical demand = 4, Temporal demand = 6, Performance = 3, Effort = 3, Frustration = 5.|||
71053478|NCT01398943|141611094|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71053479|NCT01398943|141611094|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
71077918|NCT02913105|141664399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.88||||0.0001|TWO_SIDED|90.0|0.83|0.93|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 14||0.93|0.83|0.0001
71053480|NCT01565850|141611100|NON_INFERIORITY_OR_EQUIVALENCE|A total sample size of 150 HIV-1 infected participants, randomized in a 2:1 ratio to 2 groups, would achieve 56% power to evaluate noninferiority with respect to the response rate of HIV-1 RNA \< 50 copies/mL at Week 24 if a response rate of 0.88 for both arms, a noninferiority margin of 0.12, and the significance level of the test at a one-sided 0.025 level were assumed.|Difference in proportions|3.3||||0.64|TWO_SIDED|95.0|-11.4|18.1||The p-value for the superiority test comparing the percentages of virologic success was from the Cochran-Mantel-Haenszel test stratified by baseline HIV-1 RNA and race strata.|Cochran-Mantel-Haenszel||The difference in percentages of virologic success and its 95% confidence interval (CI) were calculated based on baseline HIV-1 RNA and race stratum-adjusted Mantel-Haenszel proportion.|The null hypothesis was that the D/C/F/TAF group is at least 12% worse than the DRV+COBI+FTC/TDF group with respect to the percentage of participants achieving HIV-1 RNA \< 50 copies/mL (response rate as defined by the snapshot analysis algorithm) at Week 24; the alternative hypothesis was that the response rate in the D/C/F/TAF group is less than 12% worse than that in the DRV+COBI +FTC/TDF group.||18.1|-11.4|0.64
71053481|NCT01565850|141611101|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the D/C/F/TAF group is at least 12% worse than the DRV+COBI+FTC/TDF group with respect to the percentage of participants achieving HIV-1 RNA \< 50 copies/mL (response rate as defined by the snapshot analysis algorithm) at Week 48; the alternative hypothesis was that the response rate in the D/C/F/TAF group is less than 12% worse than that in the DRV+COBI +FTC/TDF group.|Difference in proportions|-6.2||||0.35|TWO_SIDED|95.0|-19.9|7.4||The p-value for the superiority test comparing the percentages of virologic success was from the Cochran-Mantel-Haenszel test stratified by baseline HIV-1 RNA and race strata.|Cochran-Mantel-Haenszel||The difference in percentages of virologic success and its 95% CI were calculated based on baseline HIV-1 RNA and race stratum-adjusted Mantel-Haenszel proportion.|||7.4|-19.9|0.35
71053482|NCT01565850|141611102|SUPERIORITY_OR_OTHER||Difference in LSM|0.04||||0.67|TWO_SIDED|95.0|-0.14|0.21||The p-value, difference in least squares mean (LSM), and its 95% CI were from ANOVA model with baseline HIV-1 RNA level (≤ 100,000 or \> 100,000 copies/mL) and race (Black or non-Black) as fixed effects in the model.|ANOVA|||||0.21|-0.14|0.67
71053483|NCT01565850|141611103|SUPERIORITY_OR_OTHER||Difference in LSM|0.06||||0.5|TWO_SIDED|95.0|-0.11|0.23||The p-value, difference in LSM, and its 95% CI were from ANOVA model with baseline HIV-1 RNA level (≤ 100,000 or \> 100,000 copies/mL) and race (Black or non-Black) as fixed effects in the model.|ANOVA|||||0.23|-0.11|0.50
71106406|NCT01405196|141719768|SUPERIORITY||Odds Ratio (OR)|1.62|||||TWO_SIDED|90.0|0.64|4.09||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||4.09|0.64|
71106407|NCT01405196|141719768|SUPERIORITY||Odds Ratio (OR)|0.69|||||TWO_SIDED|90.0|0.27|1.77||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.77|0.27|
71106408|NCT01405196|141719768|SUPERIORITY||Odds Ratio (OR)|1.95|||||TWO_SIDED|90.0|0.78|4.84||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||4.84|0.78|
70851332|NCT00669409|141190546|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-16.9|14.3||||||Change at Week 1, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||14.3|-16.9|
70851333|NCT00669409|141190546|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.9|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-29.5|1.7||||||Change at Week 1, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.7|-29.5|
70851334|NCT00669409|141190546|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|8.06|||TWO_SIDED|95.0|-15.4|16.5||||||Change at Week 1, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.5|-15.4|
70932577|NCT00490139|141364828|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.887|||||TWO_SIDED|95.0|0.77|1.02|||||The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.02|0.77|
70932578|NCT00490139|141364828|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.914|||||TWO_SIDED|95.0|0.8|1.05|||||The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.05|0.80|
71106409|NCT01405196|141719768|SUPERIORITY||Odds Ratio (OR)|0.94|||||TWO_SIDED|90.0|0.38|2.32||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.32|0.38|
71106410|NCT01405196|141719769|SUPERIORITY||Odds Ratio (OR)|1.05|||||TWO_SIDED|90.0|0.28|3.88||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||3.88|0.28|
71106411|NCT01405196|141719769|SUPERIORITY||Odds Ratio (OR)|0.75|||||TWO_SIDED|90.0|0.19|3.01||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||3.01|0.19|
71106412|NCT01405196|141719769|SUPERIORITY||Odds Ratio (OR)|0.72|||||TWO_SIDED|90.0|0.28|1.85||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.85|0.28|
71106413|NCT01405196|141719769|SUPERIORITY||Odds Ratio (OR)|0.8|||||TWO_SIDED|90.0|0.32|2.02||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.02|0.32|
70932579|NCT00490139|141364829|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8||||0.078|TWO_SIDED|95.0|0.62|1.03|||Log Rank|Stratification was by chemotherapy timing, hormone receptor status, and axillary lymph node status.|The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.03|0.62|0.078
71020811|NCT03567239|141548977|OTHER|Median QUEST scores: Overall = 4.33, Device = 4.38, Services = 4.25.||||||||||||||||The QUEST (Quebec User Evaluation of Satisfaction with Assistive Technology) evaluates a patient's satisfaction with various assistive technologies. It has two subgroups, Device and Service on a scale of 1-5 with 5 being the best score.|Median QUEST scores: Overall = 4.33, Device = 4.38, Services = 4.25.|||
71020812|NCT04542330|141548980|SUPERIORITY||||||<|0.05|||||||Andersen-Gill Cox|||Acute infection was analysed as recurrent events using an Andersen-Gill Cox proportional hazards regression model with time since inclusion as underlying time scale. The analysis was done for the composite outcome and for all subcomponents separately, presenting Hazard Ratios (HR) with 95% Confidence Intervals (CI) for each. For all recurrent outcomes, a wash-out period of 14 days was used to define new events.||||< 0.05
71020813|NCT04542330|141548981|SUPERIORITY||||||<|0.05|||||||Regression, Cox|||Verified SARS-CoV-2 infection (first event) and all-cause hospitalisation (first event) was analysed using standard Cox proportional hazards models, but otherwise as described for primary outcome.||||< 0.05
71020814|NCT04542330|141548982|SUPERIORITY||||||<|0.05|||||||Andersen-Gill Cox|||The secondary outcome, self-reported respiratory symptoms, was analysed the same way as the primary outcome (recurrent events).||||< 0.05
71020815|NCT04542330|141548983|SUPERIORITY||||||<|0.05|||||||Regression, Cox|||Verified SARS-CoV-2 infection (first event) and all-cause hospitalisation (first event) was analysed using standard Cox proportional hazards models, but otherwise as described for the primary outcome.||||< 0.05
71020816|NCT02176642|141548984|NON_INFERIORITY|We estimated that women in the placebo group would have mean reduction of 3 UUI episodes per day. Assuming 50% improvement in UUI episodes per day is a clinically significant improvement, we estimated the experimental group would have a mean reduction of 4.5 UUI episodes per day with a SD of 1.5 UUI episodes per day. To detect such a difference with 80% power and alpha 0.05, we would need 88 participants for our analysis. To allow for a 12% dropout rate, our goal was to enroll 100 women.||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
71020817|NCT02176642|141548985|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
71020818|NCT02176642|141548986|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
71020819|NCT02176642|141548987|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.26
71020820|NCT02176642|141548988|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
71053484|NCT01565850|141611104|SUPERIORITY_OR_OTHER||Difference in LSM|45.0||||0.11|TWO_SIDED|95.0|-10.0|101.0||The p-value, difference in LSM, and its 95% CI were from ANOVA model with baseline HIV-1 RNA level (≤ 100,000 or \> 100,000 copies/mL) and race (Black or non-Black) as fixed effects in the model.|ANOVA|||||101|-10|0.11
71020821|NCT02176642|141548989|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71020822|NCT02176642|141548990|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||||||0.44
71020823|NCT02176642|141548991|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
71020824|NCT02176642|141548992|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||||||0.94
71020825|NCT02989610|141548994|SUPERIORITY|Superiority hypothesis was that 95% lower confidence bound on proportion exceeded a threshold of 60%.|||||<|0.0001|||||||Clopper-Pearson method|||Proportion with wider therapeutic window using directional stimulation was compared to a performance goal of 60%.||||<0.0001
71020826|NCT02989610|141548995|NON_INFERIORITY|Non-inferiority hypothesis was that 95% lower confidence bound on proportion exceeded a threshold of 40%.|||||<|0.0001|||||||Clopper-Pearson method|||Proportion with wider therapeutic window using directional stimulation was compared to a performance goal of 60%.||||<0.0001
71020827|NCT02989610|141548996|SUPERIORITY|||||||1|||||||t-test, 1 sided|Paired t-test.||"Comparison of UPDRS part III on medication from 3 months using omnidirectional stimulation to 6 months using directional stimulation.~The p-value presented is calculated and does not represent the threshold. The statistical test used for this endpoint is single sided, and the observed difference was in the opposite direction of the tested difference, leading to a p-value that is equivalent to 1 within the significance of the statistical software used."||||1.0000
71020828|NCT01083901|141548998|SUPERIORITY_OR_OTHER|||||||0.38|||||||ANCOVA|Changes from baseline to 16 weeks were regressed on the baseline measurement.||The null hypothesis was that the changes in total body fat-free mass in response to resistance exercise training would not be different among the groups. The expected difference in fat-free mass between the Acetaminophen and Placebo groups was 1.8 +/- 1.0% with a 3.6 +/1 1.0% increase in fat-free mass in the Placebo group. The study was designed to achieve 96% power at the 0.05 level with 10 men in the acetaminophen and placebo groups.||||0.38
71020829|NCT01083901|141548999|SUPERIORITY_OR_OTHER|||||||0.23|||||||ANCOVA|The change in fat mass was regressed on the baseline measure.||||||0.23
71020830|NCT01083901|141549000|SUPERIORITY_OR_OTHER|||||||0.3|||||||ANCOVA|Change in strength was regressed on baseline measures.||||||0.30
71020831|NCT01083901|141549001|SUPERIORITY_OR_OTHER|||||||0.37|||||||ANCOVA|Changes in strength were regressed on the baseline measure.||||||0.37
71020832|NCT04508621|141549021|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.115|TWO_SIDED|95.0|-0.6|0.1|||Mixed Model Repeated Measures|Multiple imputation used for missing data.|Treatment difference = TNX-102 SL - Placebo|||0.1|-0.6|0.115
71020833|NCT04508621|141549022|SUPERIORITY|Patients with missing data considered non-responders.|Difference in Proportions|8.0||||0.038|TWO_SIDED|95.0|0.5|15.5|||Pearson Chi-Squared|||||15.5|0.5|0.038
71020834|NCT04508621|141549023|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.55||0.03|TWO_SIDED|95.0|-6.4|-0.3|||Mixed Model Repeated Measures|Multiple imputation used for missing data.|Treatment difference = TNX-102 SL - Placebo|||-0.3|-6.4|0.030
71053485|NCT01565850|141611105|SUPERIORITY_OR_OTHER||Difference in LSM|18.0||||0.5|TWO_SIDED|95.0|-35.0|72.0||The p-value, difference in LSM, and its 95% CI were from ANOVA model with baseline HIV-1 RNA level (≤ 100,000 or \> 100,000 copies/mL) and race (Black or non-Black) as fixed effects in the model.|ANOVA|||||72|-35|0.50
71053486|NCT03611543|141611117|SUPERIORITY||||||<|0.0001||||||Information related to the INVESTIGATIONAL group.|Wilcoxon Rank-Sum test|||||||<0.0001
70851335|NCT00669409|141190546|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.8|STANDARD_ERROR_OF_MEAN|7.83|||TWO_SIDED|95.0|-27.3|3.7||||||Change at Week 1, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.7|-27.3|
71020835|NCT04508621|141549024|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.46||0.797|TWO_SIDED|95.0|-3.2|2.5|||Mixed Model Repeated Measures|Multiple imputation used for missing data.|Treatment Difference = TNX-102 SL - Placebo|||2.5|-3.2|0.797
71020836|NCT04508621|141549025|SUPERIORITY||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.8||0.004|TWO_SIDED|95.0|-3.8|-0.7|||Mixed Model Repeated Measures|Multiple imputation used for missing data.|Treatment Difference = TNX-102 SL - Placebo|||-0.7|-3.8|0.004
71020837|NCT04508621|141549026|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.74||0.101|TWO_SIDED|95.0|-2.7|0.2|||Mixed Model Repeated Measures|Multiple imputation used for missing data.|Treatment Difference = TNX-102 SL - Placebo|||0.2|-2.7|0.101
71020838|NCT04508621|141549027|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.094|TWO_SIDED|95.0|-0.6|0.0|||Mixed Model Repeated Measures|Multiple imputation used for missing data.|Treatment Difference = TNX-102 SL - Placebo|||0.0|-0.6|0.094
71020839|NCT01625286|141549061|SUPERIORITY|A hazard ratio \< 1 favours AZD5363|Hazard Ratio (HR)|0.8||||0.308|TWO_SIDED|80.0|0.6|1.06||2-sided p-value|Regression, Cox|Cox PH model including treatment and PIK3CA status as factors/covariates||||1.06|0.60|0.308
71020840|NCT01625286|141549062|SUPERIORITY||Mean Difference (Final Values)|-8.9||||0.081|TWO_SIDED|80.0|-17.1|-0.8||1-sided p-value|ANCOVA|||||-0.8|-17.1|0.081
71020841|NCT01625286|141549068|SUPERIORITY||Odds Ratio (OR)|1.53||||0.139|TWO_SIDED|80.0|0.93|2.54||1-sided p-value|Regression, Logistic|including treatment and PIK3CA status as factors/covariates||||2.54|0.93|0.139
71020842|NCT01625286|141549069|SUPERIORITY|A hazard ratio \< 1 favours AZD5363|Hazard Ratio (HR)|0.77||||0.482|TWO_SIDED|80.0|0.48|1.24||2-sided p-value|Log Rank|Cox PH model including treatment and PIK3CA status as factors/covariates||||1.24|0.48|0.482
71053487|NCT04994483|141611147|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.4308|TWO_SIDED|95.0|-1.37|0.59|||Mixed Models Analysis|||||0.59|-1.37|0.4308
71053488|NCT04994483|141611148|SUPERIORITY||Mean Difference (Final Values)|0.51||||0.4034|TWO_SIDED|95.0|-0.68|1.7|||Mixed Models Analysis|||||1.70|-0.68|0.4034
71053489|NCT03589768|141611159|OTHER|N/A, Only risk difference estimated and 95% CI reported.|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-11.9|10.3|||||Difference is calculated as the proportion in the BOOSTRIX group minus the proportion in the Td group.|||10.3|-11.9|
71053490|NCT03589768|141611160|SUPERIORITY||Risk Difference (RD)|4.62||||0.559|TWO_SIDED|95.0|-6.25|15.5|||Fisher Exact||Difference is calculated as the proportion in the BOOSTRIX group minus the proportion in the Td group.|||15.5|-6.25|0.559
71053491|NCT03589768|141611161|OTHER|Only risk difference estimated and 95% CI reported.|Risk Difference (RD)|1.2|||||TWO_SIDED|95.0|-9.3|9.8|||||||Difference is calculated as the proportion in the BOOSTRIX group minus the proportion in the Td group.|9.8|-9.3|
70851336|NCT00669409|141190546|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-22.7|STANDARD_ERROR_OF_MEAN|10.3|||TWO_SIDED|95.0|-43.1|-2.4||||||Change at Week 1, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.4|-43.1|
71020843|NCT00828516|141549099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51|STANDARD_DEVIATION|0.96|<|0.001||95.0||||This was not adjusted for multiple comparisons|t-test, 2 sided||"MYMOP uses a 7-point scale, from 0 to 6, with 0 as good as it can be, and 6 as bad as it can be. Higher values represent a worse outcome."|There will be no improvement in MYMOP profile score after 6 acupuncture treatments.||||<0.001
71053492|NCT03589768|141611162|SUPERIORITY||Risk Difference (RD)|6.06||||0.29|TWO_SIDED|95.0|-3.82|15.9|||Fisher Exact||||Difference is calculated as the proportion in the BOOSTRIX group minus the proportion in the Td group.|15.9|-3.82|0.290
71053493|NCT03589768|141611164|OTHER|Only risk difference estimated and 95% CI reported.|Risk Difference (RD)|1.5|||||TWO_SIDED|95.0|-6.4|7.3|||||||Difference is calculated as the proportion in the BOOSTRIX group minus the proportion in the Td group.|7.3|-6.4|
71053494|NCT03589768|141611165|SUPERIORITY||Ratio|7.0|||<|0.0001|TWO_SIDED|95.0|4.6|10.7|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for birth day timepoint|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|10.7|4.6|<0.0001
71053495|NCT03589768|141611165|SUPERIORITY||Ratio|4.8|||<|0.0001|TWO_SIDED|95.0|3.2|7.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for Prior to receipt of first dose of DTwP (approximately 6 weeks of age) timepoint|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|7.3|3.2|<0.0001
71053496|NCT03589768|141611165|SUPERIORITY||Ratio|2.9|||<|0.0001|TWO_SIDED|95.0|1.8|4.8|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for One month after receipt of first dose of DTwP (approximately 10 weeks of age) timepoint|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|4.8|1.8|<0.0001
71053497|NCT03589768|141611165|SUPERIORITY||Ratio|0.3||||0.0068|TWO_SIDED|95.0|0.1|0.7|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for One month after receipt of last dose of DTwP (approximately 18 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|0.7|0.1|0.0068
71020844|NCT00828516|141549100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32|STANDARD_DEVIATION|0.94|<|0.001||95.0||||There will be no improvement in MYMOP profile score after 12 treatments|t-test, 2 sided||"MYMOP uses a 7-point scale, from 0 to 6, with 0 as good as it can be, and 6 as bad as it can be. Higher values represent a worse outcome."|||||<0.001
71020845|NCT05003167|141549123|SUPERIORITY||F|8.48||||0.001|TWO_SIDED|95.0|||||ANOVA|||A mixed model ANOVA with session (pre-post-training) as a main effect and participant as a random factor was run via SAS 9.4. Alpha was set at .05.||||.001
71020846|NCT05003167|141549125|SUPERIORITY||F|2.29||||0.113|TWO_SIDED|95.0|||||ANOVA|df = 2,44||A mixed model ANOVA with session (pre-post-training) as a main effect and participant as a random factor was run via SAS 9.4. Alpha was set at .05.||||.113
71020847|NCT05003167|141549126|SUPERIORITY||F|3.17||||0.052|TWO_SIDED|95.0|||||ANOVA|||A mixed model ANOVA with session (pre-post-training) as a main effect and participant as a random factor was run via SAS 9.4. Alpha was set at .05.||||.052
71020848|NCT05003167|141549127|SUPERIORITY||F|0.07||||0.931|TWO_SIDED|95.0|||||ANOVA|||"A mixed model ANOVA with session (pre-post-training) as a main effect and participant as a random factor was run via SAS 9.4. Alpha was set at .05.~Results here are for percent of breaths at major boundaries."||||.931
71020849|NCT05003167|141549127|SUPERIORITY||F|0.23||||0.164|TWO_SIDED|95.0|||||ANOVA|||A mixed model ANOVA with session (pre-post-training) as a main effect and participant as a random factor was run via SAS 9.4. Alpha was set at .05. Results reflect percent of breaths at boundaries unrelated to syntax.||||0.164
71020850|NCT02842086|141549135|NON_INFERIORITY|Noninferiority of DVY to TVD was to be concluded if the upper bound of the 2-sided 95.003% CI of the rate ratio (DVY group over TVD group) in the HIV infection incidence rate was less than 1.62.|Rate Ratio|0.468|||||TWO_SIDED|95.003|0.191|1.149||||||Noninferiority was assessed using a 95.003% confidence interval (CI) constructed using a generalized model associated with a Poisson distribution and logarithmic link with the treatment group being the main effect and with a noninferiority margin of 1.62.||1.149|0.191|
71053498|NCT03589768|141611165|SUPERIORITY||Ratio|0.3||||0.0003|TWO_SIDED|95.0|0.1|0.5|||t-test, 2 sided|Test compares differences in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months of age time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|0.5|0.1|0.0003
71053499|NCT03589768|141611166|SUPERIORITY||Ratio|0.9||||0.7102|TWO_SIDED|95.0|0.7|1.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for pre-vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.3|0.7|0.7102
71053500|NCT03589768|141611166|SUPERIORITY||Ratio|8.7|||<|0.0001|TWO_SIDED|95.0|6.2|12.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|12.0|6.2|<0.0001
71053501|NCT03589768|141611166|SUPERIORITY||Ratio|4.7|||<|0.0001|TWO_SIDED|95.0|3.3|6.6|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|6.6|3.3|<0.0001
71053502|NCT03589768|141611166|SUPERIORITY||Ratio|3.3|||<|0.0001|TWO_SIDED|95.0|2.1|5.2|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months after delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|5.2|2.1|<0.0001
71106414|NCT01405196|141719769|SUPERIORITY||Odds Ratio (OR)|0.75|||||TWO_SIDED|90.0|0.3|1.83||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.83|0.30|
71106415|NCT01405196|141719769|SUPERIORITY||Odds Ratio (OR)|0.45|||||TWO_SIDED|90.0|0.18|1.13||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.13|0.18|
71106416|NCT01405196|141719769|SUPERIORITY||Odds Ratio (OR)|1.45|||||TWO_SIDED|90.0|0.58|3.6||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||3.60|0.58|
71106417|NCT01405196|141719769|SUPERIORITY||Odds Ratio (OR)|0.74|||||TWO_SIDED|90.0|0.3|1.84||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.84|0.30|
71106418|NCT01405196|141719769|SUPERIORITY||Odds Ratio (OR)|1.78|||||TWO_SIDED|90.0|0.72|4.37||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||4.37|0.72|
71053503|NCT03589768|141611167|SUPERIORITY||Ratio|1.1||||0.7039|TWO_SIDED|95.0|0.8|1.4|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for pre-vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.4|0.8|0.7039
71053504|NCT03589768|141611167|SUPERIORITY||Ratio|18.5|||<|0.0001|TWO_SIDED|95.0|14.0|24.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|24.3|14.0|<0.0001
71053505|NCT03589768|141611167|SUPERIORITY||Ratio|10.5|||<|0.0001|TWO_SIDED|95.0|8.1|13.7|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|13.7|8.1|<0.0001
71020851|NCT02842086|141549136|SUPERIORITY||Difference in least squares mean (LSM)|1.142|||<|0.0001|TWO_SIDED|95.0|0.628|1.655|||ANOVA|||Hip BMD results were compared between the 2 treatment groups using analysis of variance (ANOVA), which included baseline TVD for pre-exposure prophylaxis (PrEP) and treatment as fixed effects.||1.655|0.628|<0.0001
71020852|NCT02842086|141549137|SUPERIORITY||Difference in LSM|1.567|||<|0.0001|TWO_SIDED|95.0|0.913|2.22|||ANOVA|||Spine BMD results were compared between the 2 treatment groups using ANOVA, which included baseline TVD for PrEP and treatment as fixed effects.||2.220|0.913|<0.0001
71020853|NCT02842086|141549138|SUPERIORITY||||||<|0.0001||||||P-values were from the Van Elteren test stratified by baseline TVD for PrEP.|Van Elteren test|||||||<0.0001
71020854|NCT02842086|141549139|SUPERIORITY||||||<|0.0001||||||P-values were from the Van Elteren test stratified by baseline TVD for PrEP.|Van Elteren test|||||||<0.0001
71020855|NCT02842086|141549140|SUPERIORITY|||||||0.0048||||||P-value for difference between treatment groups in distributions of UPCR ≤ 200 mg/g versus \> 200 mg/g was from the rank analysis of covariance adjusting for baseline category and baseline TVD for PrEP.|Rank analysis of covariance|||||||0.0048
71020856|NCT02842086|141549141|SUPERIORITY||Difference in LSM|-0.02|||<|0.0001|TWO_SIDED|95.0|-0.02|-0.01|||ANCOVA|||Results were compared between the 2 treatment groups using the analysis of covariance (ANCOVA) model including baseline TVD for PrEP and treatment as fixed effects and baseline serum creatinine as a covariate.||-0.01|-0.02|<0.0001
71020857|NCT02842086|141549142|NON_INFERIORITY|Noninferiority of DVY to TVD was to be concluded if the upper bound of the 2-sided 95.003% CI of the rate ratio (DVY group over TVD group) in the HIV infection incidence rate was less than 1.62.|Rate Ratio|0.536|||||TWO_SIDED|95.003|0.227|1.264||||||Noninferiority was assessed using a 95.003% CI constructed using a generalized model associated with a Poisson distribution and logarithmic link with the treatment group being the main effect and with a noninferiority margin of 1.62.||1.264|0.227|
71020858|NCT02842086|141549143|SUPERIORITY||Difference in LSM|1.567|||<|0.0001|TWO_SIDED|95.0|0.896|2.237|||ANOVA|||Hip BMD results were compared between the 2 treatment groups using ANOVA, which included baseline TVD for PrEP and treatment as fixed effects.||2.237|0.896|<0.0001
71020859|NCT02842086|141549144|SUPERIORITY||Difference in LSM|2.253|||<|0.0001|TWO_SIDED|95.0|1.437|3.069|||ANOVA|||Spine BMD results were compared between the 2 treatment groups using ANOVA, which included baseline TVD for PrEP and treatment as fixed effects.||3.069|1.437|<0.0001
71020860|NCT02842086|141549145|SUPERIORITY||||||<|0.0001||||||P-values were from the Van Elteren test stratified by baseline TVD for PrEP.|Van Elteren test|||||||<0.0001
71020861|NCT02842086|141549146|SUPERIORITY||||||<|0.0001||||||P-values were from the Van Elteren test stratified by baseline TVD for PrEP.|Van Elteren test|||||||<0.0001
71020862|NCT02842086|141549147|SUPERIORITY|||||||0.2163||||||P-value for difference between treatment groups in distributions of UPCR ≤ 200 mg/g versus \> 200 mg/g was from the rank analysis of covariance adjusting for baseline category and baseline TVD for PrEP.|Rank analysis of covariance|||||||0.2163
71020863|NCT02842086|141549148|SUPERIORITY||Difference in LSM|-0.02|||<|0.0001|TWO_SIDED|95.0|-0.02|-0.01|||ANCOVA|||Results were compared between the 2 treatment groups using the ANCOVA model including baseline TVD for PrEP and treatment as fixed effects and baseline serum creatinine as a covariate.||-0.01|-0.02|<0.0001
71020864|NCT03751124|141549151|OTHER|Chi-square test was used for the comparison between relugolix plus E2/NETA group and placebo group.|Treatment difference|63.36|||<|0.0001|TWO_SIDED|95.0|52.85|73.86||P-value was based on the stratified test statistics via log-log transformation of the difference in survival curve at a fixed time point stratified by pivotal study baseline MBL volume and duration of prior exposure to relugolix.|Log-Log transformation|Log-Log transformation of survival curve based on stratified Kaplan-Meier analysis|The 95% confidence interval (CI) of treatment difference was calculated via linear transformation of the difference in survival function with pooled variance.|The primary efficacy analysis was the comparison of the relugolix plus E2/NETA group with the placebo group with respect to responder rate.||73.86|52.85|<0.0001
71020865|NCT03751124|141549152|OTHER|Stratified log-rank test was used for the comparison between relugolix plus E2/NETA group and placebo group.|Hazard Ratio (HR)|0.13|||<|0.0001|TWO_SIDED|95.0|0.08|0.2||P-value for comparison of relugolix plus E2/NETA to placebo was based on the stratified log-rank test.|Log Rank||Hazard ratio (95% CI) of relugolix plus E2/NETA to placebo was based on a proportional hazard model stratified by pivotal study baseline MBL volume (\<225 mL or ≥225 mL) and duration of prior exposure to relugolix (28 weeks or 52 weeks).|||0.20|0.08|<0.0001
71053506|NCT03589768|141611167|SUPERIORITY||Ratio|7.4|||<|0.0001|TWO_SIDED|95.0|5.0|11.1|||t-test, 2 sided|Difference in log values back transformed into ratio.||Statistical analysis for 6 months after delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|11.1|5.0|<0.0001
71053507|NCT03589768|141611168|SUPERIORITY||Ratio|1.2||||0.2897|TWO_SIDED|95.0|0.8|1.8|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for pre-vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.8|0.8|0.2897
71053508|NCT03589768|141611168|SUPERIORITY||Ratio|54.2|||<|0.0001|TWO_SIDED|95.0|35.6|82.4|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|82.4|35.6|<0.0001
71020866|NCT03751124|141549153|OTHER|Chi-square test was used for the comparison between relugolix plus E2/NETA group and placebo group.|Treatment difference|58.04|||<|0.0001|TWO_SIDED|95.0|46.97|69.11||P-value was based on the stratified test statistics via log-log transformation of the difference in survival curve at a fixed time point stratified by pivotal study baseline MBL volume and duration of prior exposure to relugolix.|Log-Log transformation|Log-Log transformation of survival curve based on stratified Kaplan-Meier analysis|The 95% CI of treatment difference was calculated via linear transformation of the difference in survival function with pooled variance.|||69.11|46.97|<0.0001
71020867|NCT03751124|141549154|SUPERIORITY||Treatment difference|44.12|||<|0.0001|TWO_SIDED|95.0|33.13|55.11||P-value for difference between relugolix plus E2/NETA and placebo is based on Cochran-Mantel-Haenszel test stratified by pivotal study baseline MBL volume (\<225 mL or ≥225 mL) and duration of prior exposure to relugolix (28 weeks or 52 weeks).|Cochran-Mantel-Haenszel||Treatment difference is relugolix plus E2/NETA minus placebo. 95% CI for difference is based on the normal approximation.|||55.11|33.13|<0.0001
71020868|NCT05166421|141549208|OTHER||Geometric mean ratio|0.938|||||TWO_SIDED|90.0|0.8458|1.0403||||||Statistical Comparison of AUCinf of AZD7442||1.0403|0.8458|
71020869|NCT05166421|141549208|OTHER||Geometric mean ratio|0.9968|||||TWO_SIDED|90.0|0.898|1.1066||||||Statistical Comparison of AUCinf of AZD7442||1.1066|0.8980|
71053509|NCT03589768|141611168|SUPERIORITY||Ratio|32.0|||<|0.0001|TWO_SIDED|95.0|20.6|49.7|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|49.7|20.6|<0.0001
71053510|NCT03589768|141611168|SUPERIORITY||Ratio|18.9|||<|0.0001|TWO_SIDED|95.0|10.4|34.2|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months after delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|34.2|10.4|<0.0001
71053511|NCT03589768|141611169|SUPERIORITY||Ratio|1.0||||0.837|TWO_SIDED|95.0|0.6|1.5|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for pre-vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.5|0.6|0.8370
71053512|NCT03589768|141611169|SUPERIORITY||Ratio|0.6|||<|0.0001|TWO_SIDED|95.0|0.5|0.8|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|0.8|0.5|<0.0001
71053513|NCT03589768|141611169|SUPERIORITY||Ratio|0.7||||0.005|TWO_SIDED|95.0|0.6|0.9|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|0.9|0.6|0.0050
71053514|NCT03589768|141611169|SUPERIORITY||Ratio|0.8||||0.0689|TWO_SIDED|95.0|0.6|1.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months after delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.0|0.6|0.0689
71053515|NCT03589768|141611170|SUPERIORITY||Ratio|1.0||||0.8361|TWO_SIDED|95.0|0.7|1.6|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for pre-vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.6|0.7|0.8361
71053516|NCT03589768|141611170|SUPERIORITY||Ratio|0.9||||0.5136|TWO_SIDED|95.0|0.6|1.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.3|0.6|0.5136
71053517|NCT03589768|141611170|SUPERIORITY||Ratio|0.9||||0.4237|TWO_SIDED|95.0|0.6|1.2|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.2|0.6|0.4237
71053518|NCT03589768|141611170|SUPERIORITY||Ratio|0.7||||0.1607|TWO_SIDED|95.0|0.4|1.2|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months after delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.2|0.4|0.1607
71053519|NCT03589768|141611171|SUPERIORITY||Ratio|13.7|||<|0.0001|TWO_SIDED|95.0|10.2|18.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for birth time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|18.3|10.2|<0.0001
71053520|NCT03589768|141611171|SUPERIORITY||Ratio|10.8|||<|0.0001|TWO_SIDED|95.0|8.0|14.5|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for prior to receipt of first dose of DTwP (approximately 6 weeks of age)|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|14.5|8.0|<0.0001
71053521|NCT03589768|141611171|SUPERIORITY||Ratio|10.2|||<|0.0001|TWO_SIDED|95.0|6.9|15.2|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio. Test compares difference in log values.|Statistical analysis for one month after receipt of first dose of DTwP (approximately 10 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|15.2|6.9|<0.0001
71053522|NCT03589768|141611171|SUPERIORITY||Ratio|2.1||||0.0002|TWO_SIDED|95.0|1.4|3.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of last dose of DTwP (approximately 18 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|3.0|1.4|0.0002
71053523|NCT03589768|141611171|SUPERIORITY||Ratio|1.2||||0.4828|TWO_SIDED|95.0|0.8|1.7|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months of age time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.7|0.8|0.4828
71020870|NCT05166421|141549208|OTHER||Geometric mean ratio|1.0627|||||TWO_SIDED|90.0|0.9579|1.179||||||Statistical Comparison of AUCinf of AZD7442||1.1790|0.9579|
71020871|NCT05166421|141549208|OTHER||Geometric mean ratio|0.8992|||||TWO_SIDED|90.0|0.8107|0.9974||||||Statistical Comparison of AUCinf of AZD8895||0.9974|0.8107|
71020872|NCT05166421|141549208|OTHER||Geometric mean ratio|0.9826|||||TWO_SIDED|90.0|0.8854|1.0905||||||Statistical Comparison of AUCinf of AZD8895||1.0905|0.8854|
71020873|NCT05166421|141549208|OTHER||Geometric mean ratio|1.0928|||||TWO_SIDED|90.0|0.9853|1.212||||||Statistical Comparison of AUCinf of AZD8895||1.2120|0.9853|
71053524|NCT03589768|141611172|SUPERIORITY||Ratio|46.4|||<|0.0001|TWO_SIDED|95.0|26.6|81.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for birth time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|81.0|26.6|<0.0001
71053525|NCT03589768|141611172|SUPERIORITY||Ratio|39.5|||<|0.0001|TWO_SIDED|95.0|24.0|65.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for prior to receipt of first dose of DTwP (approximately 6 weeks of age)|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|65.0|24.0|<0.0001
71053526|NCT03589768|141611172|SUPERIORITY||Ratio|10.4|||<|0.0001|TWO_SIDED|95.0|6.1|17.9|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of first dose of DTwP (approximately 10 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|17.9|6.1|<0.0001
71053527|NCT03589768|141611172|SUPERIORITY||Ratio|0.6||||0.0746|TWO_SIDED|95.0|0.3|1.1|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of last dose of DTwP (approximately 18 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.1|0.3|0.0746
71053528|NCT03589768|141611172|SUPERIORITY||Ratio|0.7||||0.1532|TWO_SIDED|95.0|0.5|1.1|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months of age time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.1|0.5|0.1532
71053529|NCT03589768|141611173|SUPERIORITY||Ratio|0.7||||0.0022|TWO_SIDED|95.0|0.6|0.9|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for birth time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|0.9|0.6|0.0022
71053530|NCT03589768|141611173|SUPERIORITY||Ratio|0.7||||0.0008|TWO_SIDED|95.0|0.5|0.8|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for prior to receipt of first dose of DTwP (approximately 6 weeks of age)|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|0.8|0.5|0.0008
71020874|NCT05166421|141549208|OTHER||Geometric mean ratio|1.0039|||||TWO_SIDED|90.0|0.9029|1.1161||||||Statistical Comparison of AUCinf of AZD1061||1.1161|0.9029|
71053531|NCT03589768|141611173|SUPERIORITY||Ratio|0.7||||0.0261|TWO_SIDED|95.0|0.5|1.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of first dose of DTwP (approximately 10 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.0|0.5|0.0261
71053532|NCT03589768|141611173|SUPERIORITY||Ratio|0.6||||0.0532|TWO_SIDED|95.0|0.3|1.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of last dose of DTwP (approximately 18 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.0|0.3|0.0532
71106419|NCT01405196|141719769|SUPERIORITY||Odds Ratio (OR)|1.21|||||TWO_SIDED|90.0|0.5|2.92||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.92|0.50|
71106420|NCT01405196|141719769|SUPERIORITY||Odds Ratio (OR)|2.22|||||TWO_SIDED|90.0|0.89|5.55||||||Week 24: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||5.55|0.89|
71106421|NCT01405196|141719769|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|90.0|0.4|2.46||||||Week 24: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.46|0.40|
71106422|NCT01405196|141719770|SUPERIORITY||Odds Ratio (OR)|1.34|||||TWO_SIDED|90.0|0.53|3.35||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||3.35|0.53|
71020875|NCT05166421|141549208|OTHER||Geometric mean ratio|1.0336|||||TWO_SIDED|90.0|0.9288|1.1503||||||Statistical Comparison of AUCinf of AZD1061||1.1503|0.9288|
71106423|NCT01405196|141719770|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|90.0|0.41|2.65||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.65|0.41|
71020876|NCT05166421|141549208|OTHER||Geometric mean ratio|1.0296|||||TWO_SIDED|90.0|0.9258|1.1451||||||Statistical Comparison of AUCinf of AZD1061||1.1451|0.9258|
71020877|NCT05166421|141549209|OTHER||Geometric mean ratio|0.9418|||||TWO_SIDED|90.0|0.8512|1.0421||||||Statistical Comparison of AUClast of AZD7442||1.0421|0.8512|
71020878|NCT05166421|141549209|OTHER||Geometric mean ratio|0.9973|||||TWO_SIDED|90.0|0.9004|1.1046||||||Statistical Comparison of AUClast of AZD7442||1.1046|0.9004|
71020879|NCT05166421|141549209|OTHER||Geometric mean ratio|1.0589|||||TWO_SIDED|90.0|0.9559|1.173||||||Statistical Comparison of AUClast of AZD7442||1.1730|0.9559|
71020880|NCT05166421|141549209|OTHER||Geometric mean ratio|0.8812|||||TWO_SIDED|90.0|0.7933|0.9788||||||Statistical Comparison of AUClast of AZD8895||0.9788|0.7933|
71020881|NCT05166421|141549209|OTHER||Geometric mean ratio|0.96|||||TWO_SIDED|90.0|0.8633|1.0674||||||Statistical Comparison of AUClast of AZD8895||1.0674|0.8633|
70932580|NCT00490139|141364829|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.433|TWO_SIDED|95.0|0.71|1.16|||Log Rank|Stratification was by chemotherapy timing, hormone receptor status, and axillary lymph node status.|The estimate of the treatment hazard ratio (tras followed by lap versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.16|0.71|0.433
70932581|NCT00490139|141364830|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.853|||||TWO_SIDED|95.0|0.7|1.03|||||The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.03|0.70|
70932582|NCT00490139|141364830|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.863|||||TWO_SIDED|95.0|0.71|1.04|||||The estimate of the treatment hazard ratio (tras followed by lap versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.04|0.71|
70932583|NCT00490139|141364831|SUPERIORITY_OR_OTHER_LEGACY|Time to recurrence was analyzed using competing risks methodology with death (without event) as a competing risk.|Hazard Ratio (HR)|0.811|||||TWO_SIDED|95.0|0.68|0.96||||||||0.96|0.68|
70932584|NCT00490139|141364831|SUPERIORITY_OR_OTHER_LEGACY|Time to recurrence was analyzed using competing risks methodology with death (without event) as a competing risk.|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.79|1.1||||||||1.10|0.79|
70932585|NCT00490139|141364832|SUPERIORITY_OR_OTHER_LEGACY|Time to distant recurrence was analyzed using competing risks methodology with death (without event) as a competing risk.|Hazard Ratio (HR)|0.852|||||TWO_SIDED|95.0|0.71|1.02||||||||1.02|0.71|
70932586|NCT00490139|141364832|SUPERIORITY_OR_OTHER_LEGACY|Time to distant recurrence was analyzed using competing risks methodology with death (without event) as a competing risk.|Hazard Ratio (HR)|0.968|||||TWO_SIDED|95.0|0.81|1.16||||||||1.16|0.81|
70932587|NCT00490139|141364833|SUPERIORITY_OR_OTHER_LEGACY|Time to CNS recurrence was analyzed using competing risks methodology with death (without event) as a competing risk.|Hazard Ratio (HR)|0.986|||||TWO_SIDED|95.0|0.74|1.31||||||||1.31|0.74|
70932588|NCT00490139|141364833|SUPERIORITY_OR_OTHER_LEGACY|Time to CNS recurrence was analyzed using competing risks methodology with death (without event) as a competing risk.|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.74|1.31||||||||1.31|0.74|
70932589|NCT03301467|141364836|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.967|TWO_SIDED|95.0|-1.9|1.8|||ANCOVA|||||1.8|-1.9|0.9670
70932590|NCT03301467|141364837|SUPERIORITY||Mean Difference (Final Values)|1.02||||0.3083|TWO_SIDED||||||Van Elteren's Test||"Test for normality showed that mean change and mean percent change were not normally distributed. As per SAP, Van Elteren's test was then applied to test mean percent change.~SAP=Statistical Analysis Protocol"|||||0.3083
70932591|NCT03301467|141364838|SUPERIORITY|||||||0.4591|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel chi square general association statistic||||||0.4591
70932592|NCT03301467|141364839|SUPERIORITY|||||||0.3106|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel chi square general association statistic||||||0.3106
70932593|NCT03301467|141364840|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.3368|TWO_SIDED|95.0|-1.5|0.5|||ANCOVA|||||0.5|-1.5|0.3368
70932594|NCT03301467|141364841|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.0401|TWO_SIDED|95.0|-1.7|0.0|||ANCOVA|||||-0.0|-1.7|0.0401
70932595|NCT03301467|141364842|SUPERIORITY||Mean Difference (Final Values)|10.84||||0.0534|TWO_SIDED|95.0|-0.16|21.85|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||||21.85|-0.16|0.0534
70932596|NCT03301467|141364843|SUPERIORITY||Mean Difference (Final Values)|10.67||||0.0221|TWO_SIDED|95.0|1.56|19.78|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||||19.78|1.56|0.0221
70932597|NCT03301467|141364844|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.2638|TWO_SIDED|95.0|-3.08|11.08|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||||11.08|-3.08|0.2638
71020882|NCT05166421|141549209|OTHER||Geometric mean ratio|1.0894|||||TWO_SIDED|90.0|0.9796|1.2116||||||Statistical Comparison of AUClast of AZD8895||1.2116|0.9796|
71020883|NCT05166421|141549209|OTHER||Geometric mean ratio|1.0065|||||TWO_SIDED|90.0|0.9061|1.118||||||Statistical Comparison of AUClast of AZD1061||1.1180|0.9061|
71020884|NCT05166421|141549209|OTHER||Geometric mean ratio|1.0293|||||TWO_SIDED|90.0|0.9257|1.1446||||||Statistical Comparison of AUClast of AZD1061||1.1446|0.9257|
71020885|NCT05166421|141549209|OTHER||Geometric mean ratio|1.0227|||||TWO_SIDED|90.0|0.9196|1.1373||||||Statistical Comparison of AUClast of AZD1061||1.1373|0.9196|
71020886|NCT05166421|141549210|OTHER||Geometric mean ratio|1.0308|||||TWO_SIDED|90.0|0.9451|1.1243||||||Statistical Comparison of Cmax of AZD7442||1.1243|0.9451|
71020887|NCT05166421|141549210|OTHER||Geometric mean ratio|0.993|||||TWO_SIDED|90.0|0.9112|1.0822||||||Statistical Comparison of Cmax of AZD7442||1.0822|0.9112|
71020888|NCT05166421|141549210|OTHER||Geometric mean ratio|0.9634|||||TWO_SIDED|90.0|0.8833|1.0507||||||Statistical Comparison of Cmax of AZD7442||1.0507|0.8833|
71020889|NCT05166421|141549210|OTHER||Geometric mean ratio|0.9701|||||TWO_SIDED|90.0|0.8894|1.0582||||||Statistical Comparison of Cmax of AZD8895||1.0582|0.8894|
71020890|NCT05166421|141549210|OTHER||Geometric mean ratio|0.9629|||||TWO_SIDED|90.0|0.8835|1.0494||||||Statistical Comparison of Cmax of AZD8895||1.0494|0.8835|
71020891|NCT05166421|141549210|OTHER||Geometric mean ratio|0.9926|||||TWO_SIDED|90.0|0.91|1.0826||||||Statistical Comparison of Cmax of AZD8895||1.0826|0.9100|
71020892|NCT05166421|141549210|OTHER||Geometric mean ratio|1.0976|||||TWO_SIDED|90.0|0.9992|1.2057||||||Statistical Comparison of Cmax of AZD1061||1.2057|0.9992|
71020893|NCT05166421|141549210|OTHER||Geometric mean ratio|1.0195|||||TWO_SIDED|90.0|0.929|1.119||||||Statistical Comparison of Cmax of AZD1061||1.1190|0.9290|
71020894|NCT05166421|141549210|OTHER||Geometric mean ratio|0.9289|||||TWO_SIDED|90.0|0.8457|1.0203||||||Statistical Comparison of Cmax of AZD1061||1.0203|0.8457|
71020895|NCT03958071|141549222|OTHER||Absolute standardized differences (ASD)|-0.1027||||0.281|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||0.2810
71020896|NCT03958071|141549222|OTHER||Absolute standardized differences (ASD)|-0.078||||0.1421|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||0.1421
70932598|NCT03301467|141364845|SUPERIORITY||Mean Difference (Final Values)|3.82||||0.2069|TWO_SIDED|95.0|-2.14|9.77|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||||9.77|-2.14|0.2069
71020897|NCT03958071|141549222|OTHER||Absolute standardized differences (ASD)|0.0159||||0.0048|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||0.0048
71020898|NCT03958071|141549224|OTHER||Absolute standardized differences (ASD)|0.0214||||0.7681|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||0.7681
71020899|NCT03958071|141549224|OTHER||Absolute standardized differences (ASD)|0.371|||<|0.0001|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||<.0001
71020900|NCT03958071|141549224|OTHER||Absolute standardized differences (ASD)|0.349|||<|0.0001|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||<.0001
71020901|NCT03958071|141549225|OTHER||Absolute standardized differences (ASD)|-0.1257||||0.1659|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||0.1659
71020902|NCT03958071|141549225|OTHER||Absolute standardized differences (ASD)|0.1566||||0.0112|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||0.0112
71020903|NCT03958071|141549225|OTHER||Absolute standardized differences (ASD)|0.3019|||<|0.0001|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||<.0001
71020904|NCT03958071|141549226|OTHER||Absolute standardized differences (ASD)|-0.0209||||0.326|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||0.3260
71020905|NCT03958071|141549226|OTHER||Absolute standardized differences (ASD)|-0.2694|||<|0.0001|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||<.0001
71053533|NCT03589768|141611173|SUPERIORITY||Ratio|0.9||||0.5587|TWO_SIDED|95.0|0.5|1.4|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months of age time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.4|0.5|0.5587
71053534|NCT03589768|141611174|SUPERIORITY||Ratio|0.9||||0.5056|TWO_SIDED|95.0|0.6|1.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for birth time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.3|0.6|0.5056
71020906|NCT03958071|141549226|OTHER||Absolute standardized differences (ASD)|-0.2352|||<|0.0001|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||<.0001
71053535|NCT03589768|141611174|SUPERIORITY||Ratio|1.0||||0.9466|TWO_SIDED|95.0|0.7|1.5|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for prior to receipt of first dose of DTwP (approximately 6 weeks of age)|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.5|0.7|0.9466
71053536|NCT03589768|141611174|SUPERIORITY||Ratio|1.1||||0.6911|TWO_SIDED|95.0|0.6|2.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of first dose of DTwP (approximately 10 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|2.0|0.6|0.6911
71053537|NCT03589768|141611174|SUPERIORITY||Ratio|0.6||||0.0952|TWO_SIDED|95.0|0.3|1.1|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of last dose of DTwP (approximately 18 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.1|0.3|0.0952
71053538|NCT03589768|141611174|SUPERIORITY||Ratio|1.2||||0.4134|TWO_SIDED|95.0|0.8|2.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months of age time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|2.0|0.8|0.4134
71020907|NCT03958071|141549227|OTHER||Absolute standardized differences (ASD)|0.09||||0.2042|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||0.2042
71020908|NCT03958071|141549227|OTHER||Absolute standardized differences (ASD)|0.21|||<|0.0001|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||<.0001
71020909|NCT03958071|141549227|OTHER||Absolute standardized differences (ASD)|0.11||||0.02|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||0.02
71053539|NCT03589768|141611175|SUPERIORITY||Ratio|1.6||||0.0859|TWO_SIDED|95.0|0.9|2.6|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for birth time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|2.6|0.9|0.0859
71020910|NCT03958071|141549228|OTHER||Absolute standardized differences (ASD)|0.0241||||0.7395|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||0.7395
71020911|NCT03958071|141549228|OTHER||Absolute standardized differences (ASD)|0.1644||||0.0017|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||0.0017
71020912|NCT03958071|141549228|OTHER||Absolute standardized differences (ASD)|0.1403||||0.0034|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||0.0034
71020913|NCT04084028|141549238|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|||||||0.91
71020914|NCT04084028|141549239|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
71020915|NCT04084028|141549240|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|||||||0.91
71020916|NCT04084028|141549241|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|||||||.19
71020917|NCT04084028|141549242|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||||||.77
71020918|NCT04084028|141549243|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|||||||.06
71106424|NCT01405196|141719770|SUPERIORITY||Odds Ratio (OR)|0.81|||||TWO_SIDED|90.0|0.33|1.96||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.96|0.33|
71106425|NCT01405196|141719770|SUPERIORITY||Odds Ratio (OR)|0.93|||||TWO_SIDED|90.0|0.39|2.23||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.23|0.39|
71106426|NCT01405196|141719770|SUPERIORITY||Odds Ratio (OR)|1.01|||||TWO_SIDED|90.0|0.42|2.45||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.45|0.42|
71106427|NCT01405196|141719770|SUPERIORITY||Odds Ratio (OR)|1.31|||||TWO_SIDED|90.0|0.55|3.1||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||3.10|0.55|
71106428|NCT01405196|141719770|SUPERIORITY||Odds Ratio (OR)|2.36|||||TWO_SIDED|90.0|0.95|5.88||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||5.88|0.95|
71106429|NCT01405196|141719770|SUPERIORITY||Odds Ratio (OR)|1.82|||||TWO_SIDED|90.0|0.74|4.46||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||4.46|0.74|
71106430|NCT01405196|141719770|SUPERIORITY||Odds Ratio (OR)|2.8|||||TWO_SIDED|90.0|1.1|7.12||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||7.12|1.10|
71106431|NCT01405196|141719770|SUPERIORITY||Odds Ratio (OR)|1.67|||||TWO_SIDED|90.0|0.66|4.21||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||4.21|0.66|
71106432|NCT01405196|141719770|SUPERIORITY||Odds Ratio (OR)|2.95|||||TWO_SIDED|90.0|1.18|7.41||||||Week 24: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||7.41|1.18|
71106433|NCT01405196|141719770|SUPERIORITY||Odds Ratio (OR)|2.03|||||TWO_SIDED|90.0|0.82|5.06||||||Week 24: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||5.06|0.82|
71106434|NCT01405196|141719771|SUPERIORITY||Odds Ratio (OR)|1.59||||0.205|TWO_SIDED|90.0|0.63|4.02||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||\>=4 points reduction in SLEDAI score: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||4.02|0.63|0.205
71106435|NCT01405196|141719771|SUPERIORITY||Odds Ratio (OR)|0.84||||0.625|TWO_SIDED|90.0|0.34|2.08||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||\>=4 points reduction in SLEDAI score: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.08|0.34|0.625
71106436|NCT01405196|141719771|SUPERIORITY||Odds Ratio (OR)|2.81||||0.198|TWO_SIDED|90.0|0.38|20.65||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||No worsening in PhGA: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||20.65|0.38|0.198
71106437|NCT01405196|141719771|SUPERIORITY||Odds Ratio (OR)|2.88||||0.192|TWO_SIDED|90.0|0.39|21.3||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||No worsening in PhGA: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||21.30|0.39|0.192
71020919|NCT03053622|141549262|OTHER||Ratio of Geometric Least Squares Means|0.996|||||TWO_SIDED|90.0|0.807|1.23||||||||1.23|0.807|
71020920|NCT03053622|141549262|OTHER||Ratio of Geometric Least Squares Means|0.729|||||TWO_SIDED|90.0|0.591|0.898||||||||0.898|0.591|
71020921|NCT03053622|141549262|OTHER||Ratio of Geometric Least Squares Means|0.422|||||TWO_SIDED|90.0|0.343|0.518||||||||0.518|0.343|
71020922|NCT03053622|141549262|OTHER||Ratio of Geometric Least Squares Means|0.307|||||TWO_SIDED|90.0|0.249|0.379||||||||0.379|0.249|
71106438|NCT01405196|141719783|SUPERIORITY||LS mean difference|-5.41|||||TWO_SIDED|90.0|-12.3|1.49||||||Week 2: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||1.49|-12.30|
71106439|NCT01405196|141719783|SUPERIORITY||LS Mean difference|-1.39|||||TWO_SIDED|90.0|-8.21|5.42||||||Week 4: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||5.42|-8.21|
71106440|NCT01405196|141719783|SUPERIORITY||LS Mean difference|1.3|||||TWO_SIDED|90.0|-5.71|8.32||||||Week 6: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||8.32|-5.71|
71020923|NCT03053622|141549263|OTHER||Ratio of Geometric Least Squares Means|0.986|||||TWO_SIDED|90.0|0.81|1.2||||||||1.20|0.810|
71020924|NCT03053622|141549263|OTHER||Ratio of Geometric Least Squares Means|0.753|||||TWO_SIDED|90.0|0.619|0.916||||||||0.916|0.619|
71020925|NCT03053622|141549264|OTHER||Median Difference (Final Values)|0.28|||||TWO_SIDED|90.0|-0.1|48.4||||||||48.40|-0.10|
71020926|NCT03053622|141549264|OTHER||Median Difference (Final Values)|0.25|||||TWO_SIDED|90.0|-0.25|23.97|||||"In this outcome, the median difference is not calculated by subtracting two observations, it is derived by Hodges-Lehmann approach to estimating location shift. This method will give the value of 0.25."|||23.97|-0.25|
71020927|NCT02595528|141549339|SUPERIORITY||Least Squares (LS)|-2.5543||||0.0029|||||||Mixed model for repeated measures|||AGN-190584 Quadratic||||0.0029
70932599|NCT03301467|141364846|SUPERIORITY||LSM UPCR Ratio|0.98||||0.9284|TWO_SIDED|95.0|0.67|1.45|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.|LSM UPCR Ratio Week 26 vs Baseline, Avacopan:Placebo|||1.45|0.67|0.9284
71020928|NCT02595528|141549339|SUPERIORITY||Least Squares (LS)|6.6961|||<|0.0001|||||||Mixed model for repeated measures|||AGN-190584 Linear||||<0.0001
71020929|NCT02595528|141549339|SUPERIORITY||Least Squares (LS)|-69.89||||0.4126|||||||Mixed model for repeated measures|||AGN-199201 Quadratic||||0.4126
71020930|NCT02595528|141549339|SUPERIORITY||Least Squares (LS)|10.5017||||0.3752|||||||Mixed model for repeated measures|||AGN-199201 Linear||||0.3752
71020931|NCT00948025|141549340|OTHER|Mann-Whitney U test was used to derive p-values.||||||0.0433||||||"1. a priori threshold for statistical significance set at p\<0.05.~2. the p-value was not adjusted for multiple comparisons."|Wilcoxon (Mann-Whitney)|||"1. P-value comparing static 2-point discrimination per visit derived from mixed linear modeling of longitudinal data.~2. P-Value is based on Mann-Whitney U test."||||0.0433
71020932|NCT02292433|141549382|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.96|STANDARD_ERROR_OF_MEAN|4.841||0.0032|TWO_SIDED|90.0|-28.93|-10.98|||Mixed Models Analysis|||Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-10.98|-28.93|0.0032
71020933|NCT02292433|141549382|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.06|STANDARD_ERROR_OF_MEAN|3.172|<|0.0001|TWO_SIDED|90.0|-46.77|-35.35|||Mixed Models Analysis|||Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-35.35|-46.77|<0.0001
71020934|NCT02292433|141549383|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.18|STANDARD_ERROR_OF_MEAN|2.851||0.0006|TWO_SIDED|90.0|-17.16|-7.21|||Mixed Models Analysis|||Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-7.21|-17.16|0.0006
71053540|NCT03589768|141611175|SUPERIORITY||Ratio|1.4||||0.204|TWO_SIDED|95.0|0.8|2.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for prior to receipt of first dose of DTwP (approximately 6 weeks of age)|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|2.3|0.8|0.2040
71053541|NCT03589768|141611175|SUPERIORITY||Ratio|1.6||||0.0763|TWO_SIDED|95.0|1.0|2.7|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of first dose of DTwP (approximately 10 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|2.7|1.0|0.0763
71053542|NCT03589768|141611175|SUPERIORITY||Ratio|0.5||||0.0836|TWO_SIDED|95.0|0.2|1.1|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of last dose of DTwP (approximately 18 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.1|0.2|0.0836
71053543|NCT03589768|141611175|SUPERIORITY||Ratio|0.6||||0.0672|TWO_SIDED|95.0|0.3|1.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months of age time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.0|0.3|0.0672
71053544|NCT00792935|141611223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|4.4||0.847|TWO_SIDED|95.0|-7.9|9.6|||Constrained longitudinal analysis|||Using a standard deviation of 23.5 mg/dL, a sample size of at least 65 participants per treatment group would be required to have an 80% power to detect a true difference of 12.5 mg/dL between MK-0941 and glimepiride as measured by change from baseline in 24-hour WMG at Week 6.||9.6|-7.9|0.847
71053545|NCT00792935|141611224|SUPERIORITY_OR_OTHER||Proportions|-7.7||||0.361|TWO_SIDED|95.0|-23.6|8.7|||Miettinen & Nurminen method.||The estimated value represents the difference in percentages, MK-0941 minus Glimepiride.|||8.7|-23.6|0.361
71053546|NCT04663295|141611239|SUPERIORITY||Mean Difference (Net)|5.6|||<|0.001|TWO_SIDED|95.0|3.3|7.9||One-sided test at significant level of 0.025.|Wilcoxon (Mann-Whitney)|Wilcoxon Signed rank test comparing baseline and study period.||||7.9|3.3|<0.001
71020935|NCT02292433|141549383|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.81|STANDARD_ERROR_OF_MEAN|2.821|<|0.0001|TWO_SIDED|90.0|-30.73|-20.88|||Mixed Models Analysis|||Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-20.88|-30.73|<0.0001
71020936|NCT02292433|141549384|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.521|STANDARD_ERROR_OF_MEAN|0.7237||0.0447|TWO_SIDED|90.0|-2.752|-0.29|||Mixed Models Analysis|||Analysis for pre-breakfast. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-0.290|-2.752|0.0447
71020937|NCT02292433|141549384|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.949|STANDARD_ERROR_OF_MEAN|0.7249||0.0119|TWO_SIDED|90.0|-3.183|-0.716|||Mixed Models Analysis|||Analysis for pre-breakfast. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-0.716|-3.183|0.0119
71053547|NCT03954834|141611249|SUPERIORITY||LS Mean Difference|-1.91|||<|0.001|TWO_SIDED|95.0|-2.18|-1.63|||Mixed Models Analysis|||||-1.63|-2.18|<0.001
71053548|NCT03954834|141611249|SUPERIORITY||LS Mean Difference|-1.93|||<|0.001|TWO_SIDED|95.0|-2.21|-1.65|||Mixed Models Analysis|||||-1.65|-2.21|<0.001
71053549|NCT03954834|141611249|SUPERIORITY||LS Mean Difference|-2.11|||<|0.001|TWO_SIDED|95.0|-2.39|-1.83|||Mixed Models Analysis|||||-1.83|-2.39|<0.001
71053550|NCT03954834|141611250|SUPERIORITY||LS Mean Difference|-6.3|||<|0.001|TWO_SIDED|95.0|-7.8|-4.7|||Mixed Models Analysis|||||-4.7|-7.8|<0.001
71053551|NCT03954834|141611250|SUPERIORITY||LS Mean Difference|-7.1|||<|0.001|TWO_SIDED|95.0|-8.6|-5.5|||Mixed Models Analysis|||||-5.5|-8.6|<0.001
71020938|NCT02292433|141549384|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.967|STANDARD_ERROR_OF_MEAN|2.3324||0.6873|TWO_SIDED|90.0|-5.195|3.261|||Mixed Models Analysis|||Analysis for pre-lunch. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||3.261|-5.195|0.6873
71053552|NCT03954834|141611250|SUPERIORITY||LS Mean Difference|-8.8|||<|0.001|TWO_SIDED|95.0|-10.3|-7.2|||Mixed Models Analysis|||||-7.2|-10.3|<0.001
71053553|NCT03954834|141611251|SUPERIORITY||Odds Ratio (OR)|49.0|||<|0.001|TWO_SIDED|95.0|21.12|113.67|||Regression, Logistic|||||113.67|21.12|<0.001
71053554|NCT03954834|141611251|SUPERIORITY||Odds Ratio (OR)|80.39|||<|0.001|TWO_SIDED|95.0|31.8|203.19|||Regression, Logistic|||||203.19|31.80|<0.001
71053555|NCT03954834|141611251|SUPERIORITY||Odds Ratio (OR)|52.95|||<|0.001|TWO_SIDED|95.0|22.3|125.73|||Regression, Logistic|||||125.73|22.30|<0.001
71053556|NCT03954834|141611252|SUPERIORITY||LS Mean Difference|-1.5||||0.776|TWO_SIDED|95.0|-11.9|8.9|||Mixed Models Analysis|||||8.9|-11.9|0.776
71053557|NCT03954834|141611252|SUPERIORITY||LS Mean Difference|-2.6||||0.622|TWO_SIDED|95.0|-13.0|7.8|||Mixed Models Analysis|||||7.8|-13.0|0.622
71106441|NCT01405196|141719783|SUPERIORITY||LS Mean difference|4.67|||||TWO_SIDED|90.0|-2.22|11.57||||||Week 8: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||11.57|-2.22|
71106442|NCT01405196|141719783|SUPERIORITY||LS Mean difference|-3.98|||||TWO_SIDED|90.0|-11.04|3.07||||||Week 12: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||3.07|-11.04|
71053558|NCT03954834|141611252|SUPERIORITY||LS Mean Difference|-0.6||||0.908|TWO_SIDED|95.0|-11.1|9.8|||Mixed Models Analysis|||||9.8|-11.1|0.908
71053559|NCT03954834|141611253|SUPERIORITY||Odds Ratio (OR)|40.28|||<|0.001|TWO_SIDED|95.0|7.74|209.71|||Regression, Logistic|||||209.71|7.74|<0.001
71053560|NCT03954834|141611253|SUPERIORITY||Odds Ratio (OR)|34.12|||<|0.001|TWO_SIDED|95.0|6.53|178.19|||Regression, Logistic|||||178.19|6.53|<0.001
71053561|NCT03954834|141611253|SUPERIORITY||Odds Ratio (OR)|85.13|||<|0.001|TWO_SIDED|95.0|16.36|443.13|||Regression, Logistic|||||443.13|16.36|<0.001
71053562|NCT03954834|141611254|SUPERIORITY||LS Mean Difference|-37.7|||<|0.001|TWO_SIDED|95.0|-44.1|-31.2|||Mixed Models Analysis|||Morning Premeal - Fasting||-31.2|-44.1|<0.001
71053563|NCT03954834|141611254|SUPERIORITY||LS Mean Difference|-38.6|||<|0.001|TWO_SIDED|95.0|-45.1|-32.2|||Mixed Models Analysis|||Morning Premeal - Fasting||-32.2|-45.1|<0.001
71053564|NCT03954834|141611254|SUPERIORITY||LS Mean Difference|-36.5|||<|0.001|TWO_SIDED|95.0|-43.1|-29.8|||Mixed Models Analysis|||Morning Premeal - Fasting||-29.8|-43.1|<0.001
71053565|NCT03954834|141611254|SUPERIORITY||LS Mean Difference|-57.9|||<|0.001|TWO_SIDED|95.0|-68.4|-47.4|||Mixed Models Analysis|||Morning 2-hour Postmeal||-47.4|-68.4|<0.001
71053566|NCT03954834|141611254|SUPERIORITY||LS Mean Difference|-49.7|||<|0.001|TWO_SIDED|95.0|-60.3|-39.2|||Mixed Models Analysis|||Morning 2-hour Postmeal||-39.2|-60.3|<0.001
71053567|NCT03954834|141611254|SUPERIORITY||LS Mean Difference|-57.3|||<|0.001|TWO_SIDED|95.0|-68.1|-46.4|||Mixed Models Analysis|||Morning 2-hour Postmeal||-46.4|-68.1|<0.001
71053568|NCT03954834|141611254|SUPERIORITY||LS Mean Difference|-40.9|||<|0.001|TWO_SIDED|95.0|-49.6|-32.2|||Mixed Models Analysis|||Midday Premeal||-32.2|-49.6|<0.001
71053569|NCT03954834|141611254|SUPERIORITY||LS Mean Difference|-39.9|||<|0.001|TWO_SIDED|95.0|-48.6|-31.2|||Mixed Models Analysis|||Midday Premeal||-31.2|-48.6|<0.001
71053570|NCT03954834|141611254|SUPERIORITY||LS Mean Difference|-40.0|||<|0.001|TWO_SIDED|95.0|-49.0|-31.1|||Mixed Models Analysis|||Midday Premeal||-31.1|-49.0|<0.001
71053571|NCT03954834|141611254|SUPERIORITY||LS Mean Difference|-51.4|||<|0.001|TWO_SIDED|95.0|-62.5|-40.4|||Mixed Models Analysis|||Midday 2-hour Postmeal||-40.4|-62.5|<0.001
71053572|NCT03954834|141611254|SUPERIORITY||LS Mean Difference|-47.3|||<|0.001|TWO_SIDED|95.0|-58.4|-36.2|||Mixed Models Analysis|||Midday 2-hour Postmeal||-36.2|-58.4|<0.001
71053573|NCT03954834|141611254|SUPERIORITY||LS Mean Difference|-50.7|||<|0.001|TWO_SIDED|95.0|-62.1|-39.3|||Mixed Models Analysis|||Midday 2-hour Postmeal||-39.3|-62.1|<0.001
71053574|NCT03954834|141611254|SUPERIORITY||LS Mean Difference|-39.0|||<|0.001|TWO_SIDED|95.0|-47.6|-30.4|||Mixed Models Analysis|||Evening Premeal||-30.4|-47.6|<0.001
71053575|NCT03954834|141611254|SUPERIORITY||LS Mean Difference|-39.2|||<|0.001|TWO_SIDED|95.0|-47.9|-30.6|||Mixed Models Analysis|||Evening Premeal||-30.6|-47.9|<0.001
71053576|NCT03954834|141611254|SUPERIORITY||LS Mean Difference|-36.4|||<|0.001|TWO_SIDED|95.0|-45.3|-27.5|||Mixed Models Analysis|||Evening Premeal||-27.5|-45.3|<0.001
71053577|NCT03954834|141611254|SUPERIORITY||LS Mean Difference|-51.7|||<|0.001|TWO_SIDED|95.0|-63.2|-40.1|||Mixed Models Analysis|||Evening 2-hour Postmeal||-40.1|-63.2|<0.001
71053578|NCT03954834|141611254|SUPERIORITY||LS Mean Difference|-52.5|||<|0.001|TWO_SIDED|95.0|-64.1|-40.9|||Mixed Models Analysis|||Evening 2-hour Postmeal||-40.9|-64.1|<0.001
71053579|NCT03954834|141611254|SUPERIORITY||LS Mean Difference|-53.2|||<|0.001|TWO_SIDED|95.0|-65.1|-41.3|||Mixed Models Analysis|||Evening 2-hour Postmeal||-41.3|-65.1|<0.001
71053580|NCT03954834|141611254|SUPERIORITY||LS Mean Difference|-48.0|||<|0.001|TWO_SIDED|95.0|-58.6|-37.4|||Mixed Models Analysis|||Bedtime||-37.4|-58.6|<0.001
71053581|NCT03954834|141611254|SUPERIORITY||LS Mean Difference|-50.7|||<|0.001|TWO_SIDED|95.0|-61.3|-40.1|||Mixed Models Analysis|||Bedtime||-40.1|-61.3|<0.001
71053582|NCT03954834|141611254|SUPERIORITY||LS Mean Difference|-51.7|||<|0.001|TWO_SIDED|95.0|-62.6|-40.9|||Mixed Models Analysis|||||-40.9|-62.6|<0.001
71053583|NCT03954834|141611255|SUPERIORITY||Odds Ratio (OR)|12.4|||<|0.001|TWO_SIDED|95.0|6.43|23.94|||Regression, Logistic|||||23.94|6.43|<0.001
71053584|NCT03954834|141611255|SUPERIORITY||Odds Ratio (OR)|21.13|||<|0.001|TWO_SIDED|95.0|10.59|42.18|||Regression, Logistic|||||42.18|10.59|<0.001
71053585|NCT03954834|141611255|SUPERIORITY||Odds Ratio (OR)|20.1|||<|0.001|TWO_SIDED|95.0|10.09|40.04|||Regression, Logistic|||||40.04|10.09|<0.001
71053586|NCT01404923|141611280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4||||0.0008|TWO_SIDED||||||ANCOVA|||||||0.0008
71053587|NCT01284361|141611282|SUPERIORITY_OR_OTHER||Proportion|91.5|||||TWO_SIDED|95.0|84.5|97.5|||||Seventy five of the 82 subjects (91.5%) preferred the longer commercially available catheter over the experimental 30 cm catheter.|The sample size of 81 subjects provides a 10.8% margin of error.||97.5|84.5|
71020939|NCT02292433|141549384|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.439|STANDARD_ERROR_OF_MEAN|0.9533||0.0659|TWO_SIDED|90.0|-4.502|-0.377|||Mixed Models Analysis|||Analysis for pre-lunch. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-0.377|-4.502|0.0659
71020940|NCT02292433|141549384|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.358|STANDARD_ERROR_OF_MEAN|1.5994||0.4031|TWO_SIDED|90.0|-4.079|1.363|||Mixed Models Analysis|||Analysis for pre-dinner. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||1.363|-4.079|0.4031
71020941|NCT02292433|141549384|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.766|STANDARD_ERROR_OF_MEAN|1.5951||0.0254|TWO_SIDED|90.0|-6.479|-1.052|||Mixed Models Analysis|||Analysis for pre-dinner. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-1.052|-6.479|0.0254
71020942|NCT02292433|141549385|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.069||0.0067|TWO_SIDED|90.0|-0.33|-0.09|||Mixed Models Analysis|||Analysis for pre-breakfast. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-0.09|-0.33|0.0067
71020943|NCT02292433|141549385|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.071||0.0282|TWO_SIDED|90.0|-0.29|-0.05|||Mixed Models Analysis|||Analysis for pre-breakfast. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-0.05|-0.29|0.0282
71020944|NCT02292433|141549385|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.118||0.7877|TWO_SIDED|90.0|-0.18|0.25|||Mixed Models Analysis|||Analysis for pre-lunch. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||0.25|-0.18|0.7877
71020945|NCT02292433|141549385|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.156||0.5064|TWO_SIDED|90.0|-0.17|0.39|||Mixed Models Analysis|||Analysis for pre-lunch. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||0.39|-0.17|0.5064
71020946|NCT02292433|141549385|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.293||0.4072|TWO_SIDED|90.0|-0.75|0.25|||Mixed Models Analysis|||Analysis for pre-dinner. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||0.25|-0.75|0.4072
71020947|NCT02292433|141549385|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.295||0.1422|TWO_SIDED|90.0|-0.95|0.06|||Mixed Models Analysis|||Analysis for pre-dinner. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||0.06|-0.95|0.1422
71020948|NCT03101293|141549386|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as fixed effects and participant nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates of the food effect and 90% confidence intervals (CIs).|LS Mean Ratio|1.343||||0.0058|TWO_SIDED|90.0|1.146|1.574|||ANOVA|||||1.574|1.146|0.0058
71020949|NCT03101293|141549387|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as fixed effects and participant nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates of the food effect and 90% CIs.|LS Mean Ratio|1.121||||0.1763|TWO_SIDED|90.0|0.969|1.298|||ANOVA|||||1.298|0.969|0.1763
71020950|NCT03101293|141549388|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as fixed effects and participant nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates of the food effect and 90% CIs.|LS Mean Ratio|1.154||||0.2745|TWO_SIDED|90.0|0.929|1.433|||ANOVA|||||1.433|0.929|0.2745
71020951|NCT03182920|141549412|SUPERIORITY||Ratio of geometric least squares means|1.21|||||TWO_SIDED|90.0|0.962|1.52||||||||1.52|0.962|
71053588|NCT00325195|141611305|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
71053589|NCT00325195|141611305|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
71053590|NCT00325195|141611306|SUPERIORITY_OR_OTHER||||||<|0.002||95.0|||||Fisher Exact|||||||<0.002
71106443|NCT01405196|141719783|SUPERIORITY||LS Mean difference|-2.89|||||TWO_SIDED|90.0|-9.87|4.1||||||Week 16: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||4.10|-9.87|
71053591|NCT00325195|141611306|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Fisher Exact|||||||0.200
71053592|NCT00325195|141611307|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Fisher Exact|||% of pegloticase q2 participants reporting flares compared to placebo pts during Months 4-6 treatment period||||0.007
71053593|NCT00325195|141611307|SUPERIORITY_OR_OTHER|||||||0.321||95.0|||||Fisher Exact|||% of pegloticase q4 participants reporting flares compared to placebo pts during Months 4-6 treatment period||||0.321
71106444|NCT01405196|141719783|SUPERIORITY||LS Mean difference|-6.21|||||TWO_SIDED|90.0|-13.37|0.94||||||Week 20: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||0.94|-13.37|
71053594|NCT00325195|141611308|SUPERIORITY_OR_OTHER|||||||0.166||95.0|||||t-test, 2 sided|||||||0.166
71053595|NCT00325195|141611308|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||t-test, 2 sided|||||||0.170
71053596|NCT00325195|141611309|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||t-test, 2 sided|||||||0.008
71053597|NCT00325195|141611309|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||t-test, 2 sided|||||||0.024
71053598|NCT04715932|141611331|SUPERIORITY||Odds Ratio (OR)|1.49||||0.3849|TWO_SIDED|95.0|0.6|3.69|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression).||||3.69|0.60|0.3849
71053599|NCT04715932|141611332|SUPERIORITY||Odds Ratio (OR)|1.43||||0.3139|TWO_SIDED|95.0|0.71|2.88|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.88|0.71|0.3139
71053600|NCT04715932|141611333|SUPERIORITY||Odds Ratio (OR)|1.18||||0.5886|TWO_SIDED|95.0|0.65|2.14|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.14|0.65|0.5886
71020952|NCT03182920|141549413|SUPERIORITY||Ratio of geometric least squares means|1.26|||||TWO_SIDED|90.0|1.03|1.55||||||||1.55|1.03|
71106445|NCT01405196|141719783|SUPERIORITY||LS Mean difference|1.98|||||TWO_SIDED|90.0|-5.17|9.13||||||Week 24: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||9.13|-5.17|
71106446|NCT01405196|141719783|SUPERIORITY||LS Mean difference|2.07|||||TWO_SIDED|90.0|-4.7|8.84||||||Week 2: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||8.84|-4.70|
71020953|NCT01430182|141549466|SUPERIORITY_OR_OTHER|||||||0.37|||||||t-test, 1 sided|unpaired||||||0.37
71020954|NCT03137082|141549483|SUPERIORITY||||||<|0.03|||||||Mixed Models Analysis|||||||<0.03
71020955|NCT03137082|141549484|SUPERIORITY|||||||0.1|||||||Mixed Models Analysis|||||||0.1
71020956|NCT03137082|141549486|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
71020957|NCT03137082|141549487|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
71020958|NCT03137082|141549488|SUPERIORITY|||||||0.5|||||||Mixed Models Analysis|||||||0.5
71020959|NCT03137082|141549489|SUPERIORITY||||||<|0.03|||||||Mixed Models Analysis|||||||<.03
71020960|NCT03137082|141549490|SUPERIORITY|||||||0.1|||||||Mixed Models Analysis|||||||0.1
71020961|NCT03137082|141549491|SUPERIORITY||||||<|0.3|||||||Mixed Models Analysis|||||||<0.3
71020962|NCT03137082|141549492|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||0.04
71020963|NCT03137082|141549493|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||||||0.4
71020964|NCT03137082|141549494|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||0.08
71020965|NCT03137082|141549495|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.2
71020966|NCT01017029|141549505|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.482||||0.1043|TWO_SIDED|95.0|0.922|2.383|||Regression, Cox|||||2.383|0.922|0.1043
71020967|NCT01017029|141549507|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.847||||0.0398|TWO_SIDED|95.0|1.029|3.315|||Regression, Cox|||||3.315|1.029|0.0398
71020968|NCT01017029|141549509|SUPERIORITY_OR_OTHER|||||||0.0234|||||||Fisher Exact|||CMV infections||||0.0234
71020969|NCT01017029|141549510|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.403||||0.1966|TWO_SIDED|95.0|0.839|2.347|||Regression, Cox|||||2.347|0.839|0.1966
71020970|NCT02660385|141549536|SUPERIORITY||Effect Size|-0.6||||0.0002|TWO_SIDED||||||Generalized Linear Mixed Model (GLMM)|GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.||||||0.0002
71020971|NCT02660385|141549537|SUPERIORITY|||||||0.0723||||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.0723
71020972|NCT02660385|141549538|SUPERIORITY||effect size|0.42||||0.011|TWO_SIDED||||||GLMM|GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.||||||0.0110
71020973|NCT02660385|141549539|SUPERIORITY||effect size|-0.7|||<|0.0001|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||<0.0001
71020974|NCT02660385|141549540|SUPERIORITY||effect size|-0.12||||0.4356|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.4356
71020975|NCT02660385|141549541|SUPERIORITY|||||||0.0148||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0148
71020976|NCT02660385|141549542|SUPERIORITY|||||||0.013||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0130
71020977|NCT02660385|141549543|SUPERIORITY|||||||0.013||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0130
71020978|NCT02660385|141549544|SUPERIORITY|||||||0.013||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0130
71020979|NCT02660385|141549545|SUPERIORITY|||||||0.6358||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.6358
71020980|NCT02660385|141549546|SUPERIORITY||effect size|0.35||||0.0318|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.0318
71020981|NCT02660385|141549547|SUPERIORITY|||||||0.2722||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.2722
71020982|NCT02660385|141549548|SUPERIORITY||effect size|-0.27||||0.0954|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.0954
71020983|NCT02660385|141549549|SUPERIORITY|||||||0.4222||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.4222
71020984|NCT02660385|141549550|SUPERIORITY||effect size|0.09||||0.5781|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.5781
71020985|NCT02660385|141549551|SUPERIORITY|||||||0.1238||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.1238
71020986|NCT02660385|141549552|SUPERIORITY||effect size|-0.3||||0.0558|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.0558
71020987|NCT02660385|141549553|SUPERIORITY|||||||0.023||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0230
71020988|NCT02660385|141549554|SUPERIORITY||effect size|0.06||||0.4597|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.4597
71020989|NCT02660385|141549555|SUPERIORITY|||||||0.1943||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.1943
71020990|NCT02660385|141549556|SUPERIORITY||effect size|-0.23||||0.0027|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.0027
71020991|NCT02660385|141549557|SUPERIORITY|||||||0.0792||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0792
71020992|NCT02660385|141549558|SUPERIORITY||effect size|0.13||||0.0656|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.0656
71020993|NCT02660385|141549559|SUPERIORITY|||||||0.2174||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.2174
71020994|NCT02660385|141549560|SUPERIORITY||effect size|0.07||||0.7028|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.7028
71020995|NCT02660385|141549561|SUPERIORITY|||||||0.0509||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0509
71020996|NCT02660385|141549562|SUPERIORITY||Mean Difference (Final Values)|275.0|STANDARD_ERROR_OF_MEAN|1525.0||0.955|TWO_SIDED|95.0|-3288.0|2739.0|||t-test, 2 sided|||||2739|-3288|0.955
71020997|NCT02660385|141549563|SUPERIORITY|||||||0.013||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0130
71020998|NCT02660385|141549564|SUPERIORITY||effect size|-0.05||||0.7496|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.7496
71020999|NCT02660385|141549565|SUPERIORITY||effect size|0.06||||0.3821|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.3821
71021000|NCT02660385|141549566|SUPERIORITY|||||||0.7204||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.7204
71021001|NCT02981602|141549620|OTHER|||||||0.116||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.116
71021002|NCT02981602|141549620|OTHER||||||<|0.001||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||<0.001
71021003|NCT02981602|141549620|OTHER|||||||0.573||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.573
71021004|NCT02981602|141549621|OTHER|||||||0.609||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.609
71021005|NCT02981602|141549621|OTHER|||||||0.141||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.141
71021006|NCT02981602|141549622|OTHER|Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group||||||0.245|||||||ANCOVA|||||||0.245
71021007|NCT02981602|141549622|OTHER|||||||0.001||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.001
71021008|NCT02981602|141549622|OTHER|||||||0.762||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.762
71021009|NCT02981602|141549623|OTHER|||||||0.141||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.141
71021010|NCT02981602|141549623|OTHER|||||||0.081||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.081
71021011|NCT02981602|141549623|OTHER|||||||0.616||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.616
71021012|NCT02981602|141549626|OTHER|||||||0.763||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.763
71021013|NCT02981602|141549626|OTHER|||||||0.804||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.804
71021014|NCT02981602|141549627|OTHER|||||||0.372||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.372
71106447|NCT01405196|141719783|SUPERIORITY||LS Mean difference|-2.81|||||TWO_SIDED|90.0|-9.62|4.0||||||Week 4: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||4.00|-9.62|
71106448|NCT01405196|141719783|SUPERIORITY||LS Mean difference|3.97|||||TWO_SIDED|90.0|-2.95|10.9||||||Week 6: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||10.90|-2.95|
71021015|NCT02981602|141549627|OTHER|||||||0.954||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.954
71021016|NCT00423488|141549636|SUPERIORITY_OR_OTHER_LEGACY||least-squares means|-11.5||||0.005||95.0|-19.4|-3.5|||ANOVA|The analysis of variance (ANOVA) model included term of treatment effect. If more than one basal value was available, the latest was used.||||-3.5|-19.4|0.005
71021017|NCT01749033|141549654|SUPERIORITY_OR_OTHER_LEGACY|||||||0.76|||||||Chi-squared|||We planned a sample size of 429 to achieve a 80% power to detect an effect size difference of w=0.15 using 2 degrees of freedom chi-square test with a significance level (alpha) of .05.||||.76
71021018|NCT01749033|141549656|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.05|TWO_SIDED||||||Chi-squared||The reported p value was calculated.|We planned a sample size of 429 to achieve a 80% power to detect an effect size difference of w=0.15 using 2 degrees of freedom chi-square test with a significance level (alpha) of .05.||||.05
71021019|NCT00725725|141549689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5299||||0.3934|TWO_SIDED|95.0|-2.0781|5.138|||Mixed Models Analysis|||||5.1380|-2.0781|0.3934
71021020|NCT00725725|141549689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2667||||0.3515|TWO_SIDED|95.0|-1.4665|4.0|||Mixed Models Analysis|||||4.0000|-1.4665|0.3515
71021021|NCT00725725|141549690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8246||||0.3597|TWO_SIDED|95.0|-5.8307|2.1815|||Mixed Models Analysis|||||2.1815|-5.8307|0.3597
71021022|NCT00725725|141549690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4414||||0.777|TWO_SIDED|95.0|-3.5952|2.7124|||Mixed Models Analysis|||||2.7124|-3.5952|0.7770
71021023|NCT00725725|141549691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3356||||0.2683|TWO_SIDED|95.0|-1.8933|6.5644|||Mixed Models Analysis|||||6.5644|-1.8933|0.2683
71021024|NCT00725725|141549691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1317||||0.0844|TWO_SIDED|95.0|-0.4518|6.7152|||Mixed Models Analysis|||||6.7152|-0.4518|0.0844
71021025|NCT00725725|141549695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3456||||0.8894|TWO_SIDED|95.0|-4.6211|5.3124|||Mixed Models Analysis|||||5.3124|-4.6211|0.8894
71021026|NCT00725725|141549695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0417||||0.3765|TWO_SIDED|95.0|-2.5526|6.636|||Mixed Models Analysis|||||6.6360|-2.5526|0.3765
71021027|NCT00725725|141549696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2502||||0.8073|TWO_SIDED|95.0|-11.4963|8.9958|||Mixed Models Analysis|||||8.9958|-11.4963|0.8073
71021028|NCT00725725|141549696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0291||||0.661|TWO_SIDED|95.0|-7.2132|11.2714|||Mixed Models Analysis|||||11.2714|-7.2132|0.6610
71021029|NCT00725725|141549697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7296||||0.7895|TWO_SIDED|95.0|-4.7291|6.1883|||Mixed Models Analysis|||||6.1883|-4.7291|0.7895
71021030|NCT00725725|141549697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.526||||0.5488|TWO_SIDED|95.0|-3.5495|6.6015|||Mixed Models Analysis|||||6.6015|-3.5495|0.5488
71021031|NCT00725725|141549698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2766||||0.6516|TWO_SIDED|95.0|-6.9269|4.3738|||Mixed Models Analysis|||||4.3738|-6.9269|0.6516
71021032|NCT00725725|141549698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1867||||0.0256|TWO_SIDED|95.0|-11.5864|-0.7869|||Mixed Models Analysis|||||-0.7869|-11.5864|0.0256
71021033|NCT02450760|141549707|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
71021034|NCT02450760|141549708|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||||||0.95
71021035|NCT02450760|141549712|SUPERIORITY|||||||0.15|||||||Chi-squared|||||||0.15
71021036|NCT02450760|141549713|SUPERIORITY|||||||0.83|||||||Chi-squared|||||||0.83
71021037|NCT02450760|141549714|SUPERIORITY|||||||0.26|||||||Chi-squared|||||||0.26
71021038|NCT00581386|141549717|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.125||||0.013||95.0|1.27|7.67|||Regression, Logistic|Logistic regression Number of obs = 217, LR chi2(2)=10.89, Prob\>chi2=0.0043,Log likelihood = -112.87788, Pseudo R2=0.0460|this is a simple odds ratio|||7.67|1.27|0.013
71021039|NCT00581386|141549717|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.81||||0.003||95.0|1.57|9.29|||Odds ratio|||||9.29|1.57|0.003
71021040|NCT00581386|141549718|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.006||||0.006||95.0|||||t-test, 2 sided|||||||0.006
71021041|NCT00581386|141549719|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.088||||0.003||95.0|1.728|14.99|||Regression, Logistic|||||14.99|1.728|0.003
71021042|NCT00581386|141549719|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.22||||0.0004||95.0|2.419|21.527|||Regression, Logistic|||||21.527|2.419|0.0004
71021043|NCT01355523|141549721|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Chi-squared|||||||0.008
71021044|NCT01355523|141549721|SUPERIORITY_OR_OTHER||Number need to treat|2.95|||||TWO_SIDED|95.0|1.703|11.024||||||||11.024|1.703|
71021045|NCT01355523|141549721|SUPERIORITY_OR_OTHER||Relative Risk|0.25|||||TWO_SIDED|95.0|0.076|0.797||||||||0.797|0.076|
71021046|NCT01355523|141549722|SUPERIORITY_OR_OTHER|||||||0.125||95.0|||||Fisher Exact|||||||0.125
71021047|NCT01355523|141549723|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||Fisher Exact|||||||0.460
71021048|NCT01355523|141549724|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Chi-squared|||||||0.002
71021049|NCT01355523|141549725|SUPERIORITY_OR_OTHER|||||||0.264||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.264
71021050|NCT01355523|141549726|SUPERIORITY_OR_OTHER|||||||0.351||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.351
71021051|NCT01355523|141549727|SUPERIORITY_OR_OTHER|||||||0.446||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.446
71021052|NCT01355523|141549728|SUPERIORITY_OR_OTHER|||||||0.122||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.122
71021053|NCT01355523|141549729|SUPERIORITY_OR_OTHER|||||||0.907||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.907
71021054|NCT01355523|141549730|SUPERIORITY_OR_OTHER|||||||0.555||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.555
71021055|NCT01355523|141549731|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.930
71021056|NCT01355523|141549732|SUPERIORITY_OR_OTHER|||||||0.386||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.386
70932600|NCT03301467|141364847|SUPERIORITY||LSM UPCR Ratio|0.86||||0.3778|TWO_SIDED|95.0|0.6|1.21|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.|LSM UPCR Ratio Week 26 vs Baseline, Avacopan:Placebo|||1.21|0.60|0.3778
71053601|NCT04715932|141611334|SUPERIORITY||Odds Ratio (OR)|0.69||||0.2328|TWO_SIDED|95.0|0.38|1.27|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.27|0.38|0.2328
71053602|NCT04715932|141611335|SUPERIORITY||Rate Ratio|1.14||||0.156|TWO_SIDED|95.0|0.95|1.37|||Mixed Models Analysis|Generalized linear mixed model (repeated poisson regression).||||1.37|0.95|0.1560
71053603|NCT04715932|141611336|SUPERIORITY||Rate Ratio|1.06||||0.6233|TWO_SIDED|95.0|0.84|1.33|||Mixed Models Analysis|Generalized linear mixed model (repeated poisson regression)||||1.33|0.84|0.6233
71053604|NCT04715932|141611337|SUPERIORITY||Rate Ratio|1.03||||0.829|TWO_SIDED|95.0|0.78|1.37|||Mixed Models Analysis|Generalized linear mixed model (repeated poisson regression)||||1.37|0.78|0.8290
71053605|NCT04715932|141611338|SUPERIORITY||Rate Ratio|0.98||||0.9222|TWO_SIDED|95.0|0.69|1.4|||Mixed Models Analysis|Generalized linear mixed model (repeated poisson regression)||||1.40|0.69|0.9222
71053606|NCT04715932|141611339|SUPERIORITY|||||||0.8834|||||||Log Rank|||||||0.8834
71053607|NCT04715932|141611340|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9416|TWO_SIDED|95.0|0.59|1.77|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.77|0.59|0.9416
71053608|NCT04715932|141611341|SUPERIORITY||Odds Ratio (OR)|0.87||||0.6296|TWO_SIDED|95.0|0.49|1.55|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.55|0.49|0.6296
71053609|NCT04715932|141611342|SUPERIORITY||Odds Ratio (OR)|0.75||||0.3711|TWO_SIDED|95.0|0.41|1.4|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.40|0.41|0.3711
71106449|NCT01405196|141719783|SUPERIORITY||LS Mean difference|2.56|||||TWO_SIDED|90.0|-4.29|9.4||||||Week 8: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||9.40|-4.29|
71106450|NCT01405196|141719783|SUPERIORITY||LS Mean difference|3.14|||||TWO_SIDED|90.0|-3.67|9.94||||||Week 12: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||9.94|-3.67|
71021057|NCT01355523|141549733|SUPERIORITY_OR_OTHER|||||||0.241||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.241
71106451|NCT01405196|141719783|SUPERIORITY||LS Mean difference|-4.94|||||TWO_SIDED|90.0|-11.91|2.03||||||Week 16: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||2.03|-11.91|
71021058|NCT01355523|141549734|SUPERIORITY_OR_OTHER|||||||0.339||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.339
71021059|NCT01355523|141549735|SUPERIORITY_OR_OTHER|||||||0.578||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.578
71021060|NCT01355523|141549736|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||||||1.000
71021061|NCT01406873|141549756|SUPERIORITY||||||<|0.01|||||||ANCOVA|||||||<0.01
71053610|NCT04715932|141611343|SUPERIORITY||Odds Ratio (OR)|0.82||||0.5696|TWO_SIDED|95.0|0.42|1.61|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.61|0.42|0.5696
71053611|NCT04715932|141611344|SUPERIORITY||Odds Ratio (OR)|0.83||||0.7583|TWO_SIDED|95.0|0.26|2.67|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.67|0.26|0.7583
71053612|NCT04715932|141611345|SUPERIORITY||Odds Ratio (OR)|0.84||||0.8091|TWO_SIDED|95.0|0.2|3.58|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.58|0.20|0.8091
71053613|NCT04715932|141611346|SUPERIORITY||Odds Ratio (OR)|1.67||||0.5591|TWO_SIDED|95.0|0.3|9.42|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||9.42|0.30|0.5591
71053614|NCT04715932|141611347|SUPERIORITY|||||||0.9983|||||||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||||0.9983
71053615|NCT04715932|141611348|SUPERIORITY||Odds Ratio (OR)|1.6||||0.1068|TWO_SIDED|95.0|0.9|2.82|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.82|0.90|0.1068
71053616|NCT04715932|141611349|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8382|TWO_SIDED|95.0|0.57|1.98|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.98|0.57|0.8382
71053617|NCT04715932|141611350|SUPERIORITY||Odds Ratio (OR)|1.22||||0.5912|TWO_SIDED|95.0|0.59|2.51|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.51|0.59|0.5912
71053618|NCT04715932|141611352|SUPERIORITY||Odds Ratio (OR)|0.78||||0.3686|TWO_SIDED|95.0|0.45|1.35|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.35|0.45|0.3686
71053619|NCT04715932|141611353|SUPERIORITY||Odds Ratio (OR)|1.05||||0.8711|TWO_SIDED|95.0|0.59|1.86|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.86|0.59|0.8711
71053620|NCT04715932|141611354|SUPERIORITY||Odds Ratio (OR)|1.03||||0.9124|TWO_SIDED|95.0|0.57|1.87|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.87|0.57|0.9124
71053621|NCT04715932|141611355|SUPERIORITY||Odds Ratio (OR)|0.7||||0.2952|TWO_SIDED|95.0|0.36|1.37|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.37|0.36|0.2952
71053622|NCT04715932|141611356|SUPERIORITY||Odds Ratio (OR)|1.2||||0.5894|TWO_SIDED|95.0|0.62|2.34|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.34|0.62|0.5894
71053623|NCT04715932|141611357|SUPERIORITY||Odds Ratio (OR)|1.14||||0.7887|TWO_SIDED|95.0|0.45|2.89|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.89|0.45|0.7887
71053624|NCT04715932|141611358|SUPERIORITY||Odds Ratio (OR)|0.73||||0.6348|TWO_SIDED|95.0|0.2|2.7|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.70|0.20|0.6348
71053625|NCT04715932|141611359|SUPERIORITY||Odds Ratio (OR)|0.39||||0.4257|TWO_SIDED|95.0|0.04|3.92|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.92|0.04|0.4257
71053626|NCT04715932|141611360|SUPERIORITY||Odds Ratio (OR)|1.66||||0.1113|TWO_SIDED|95.0|0.89|3.11|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.11|0.89|0.1113
71053627|NCT04715932|141611361|SUPERIORITY||Odds Ratio (OR)|1.57||||0.2613|TWO_SIDED|95.0|0.71|3.47|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.47|0.71|0.2613
70932601|NCT03301467|141364848|SUPERIORITY||LSM MCP-1 Ratio|0.76||||0.081|TWO_SIDED|95.0|0.55|1.04|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.|LSM MCP-1 Ratio Week 26 vs Baseline, Avacopan:Placebo|||1.04|0.55|0.0810
70932602|NCT03301467|141364849|SUPERIORITY||LSM MCP-1 Ratio|0.87||||0.3233|TWO_SIDED|95.0|0.66|1.15|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.|LSM MCP-1 Ratio Week 26 vs Baseline, Avacopan:Placebo|||1.15|0.66|0.3233
70932603|NCT03301467|141364850|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.6025|TWO_SIDED|95.0|-4.6|7.9|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||EQ-5D-5L VAS Score||7.9|-4.6|0.6025
70932604|NCT03301467|141364850|SUPERIORITY||Mean Difference (Final Values)|-0.0422||||0.1797|TWO_SIDED|95.0|-0.1043|0.0198|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||EQ-5D-5L Index Score||0.0198|-0.1043|0.1797
70932605|NCT03301467|141364851|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.4898|TWO_SIDED|95.0|-7.9|3.8|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||EQ-5D-5L VAS Score||3.8|-7.9|0.4898
71053628|NCT04715932|141611362|SUPERIORITY||Odds Ratio (OR)|0.82||||0.7273|TWO_SIDED|95.0|0.27|2.49|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.49|0.27|0.7273
71053629|NCT04715932|141611363|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8909|TWO_SIDED|95.0|0.19|4.19|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||4.19|0.19|0.8909
71053630|NCT04715932|141611364|SUPERIORITY||Odds Ratio (OR)|1.52||||0.1438|TWO_SIDED|95.0|0.87|2.67|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.67|0.87|0.1438
70932606|NCT03301467|141364851|SUPERIORITY||Mean Difference (Final Values)|-0.0199||||0.4826|TWO_SIDED|95.0|-0.0757|0.036|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||EQ-5D-5L Index Score||0.0360|-0.0757|0.4826
70932607|NCT03301467|141364852|SUPERIORITY||Mean Difference (Final Values)|0.4019||||0.8161|TWO_SIDED|95.0|-3.0402|3.844|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||SF-36v2: Physical Component Score||3.8440|-3.0402|0.8161
70932608|NCT03301467|141364852|SUPERIORITY||Mean Difference (Final Values)|0.0052||||0.9982|TWO_SIDED|95.0|-4.5994|4.6099|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||SF-36v2: Mental Component Score||4.6099|-4.5994|0.9982
70932609|NCT03301467|141364853|SUPERIORITY||Mean Difference (Final Values)|-0.1518||||0.9242|TWO_SIDED|95.0|-3.3192|3.0156|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||SF-36v2: Physical Component Score||3.0156|-3.3192|0.9242
70932610|NCT03301467|141364853|SUPERIORITY||Mean Difference (Final Values)|1.0283||||0.6534|TWO_SIDED|95.0|-3.4972|5.5537|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||SF-36v2: Mental Component Score||5.5537|-3.4972|0.6534
70932611|NCT02798471|141364856|NON_INFERIORITY|The edoxaban-to-comparator hazard ratio will be computed with 95% confidence interval (CI) (two-sided) based on this model. Edoxaban will be considered non-inferior to comparator if the upper limit of the 95% CI is ≤1.5.|Hazard Ratio (HR)|1.01||||0.9694|TWO_SIDED|95.0|0.594|1.719|||Regression, Cox|||Statistical analysis for the composite primary efficacy endpoint||1.719|0.594|0.9694
70932612|NCT05293717|141364871|OTHER|This is an open-label study. No power calculation was performed.|||||<|0.001|||||||ANOVA|||||||<0.001
70932613|NCT00712179|141364892|SUPERIORITY_OR_OTHER|||||||0.981|||||||Mixed Models Analysis|||Null Hypothesis: Walking at different speeds with 15% body weight support will have no effect on EMG pattern.||||0.981
70932614|NCT00712179|141364892|SUPERIORITY_OR_OTHER|||||||0.84|||||||Mixed Models Analysis|||Null Hypothesis: Walking at self selected speed at 0%, 15% and 30% of body weight support will have no effect on EMG pattern||||0.84
70932615|NCT00712179|141364892|SUPERIORITY_OR_OTHER|||||||0.16|||||||Mixed Models Analysis|||Null Hypothesis: Walking at different speeds with 30% body weight support will have no effect on EMG pattern.||||0.16
70932616|NCT00712179|141364892|SUPERIORITY_OR_OTHER|||||||0.073|||||||Mixed Models Analysis|||Null Hypothesis: Walking at fastest comfortable speeds with different amount of body weight supports will not affect the EMG pattern.||||0.073
70932617|NCT00712179|141364892|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Null Hypothesis: Modification of non-paretic leg loading and movement by the therapist will have no effect on EMG pattern of paretic leg.||||<0.001
71021062|NCT02290028|141549822|SUPERIORITY||||||<|0.0001|||||||Exact, binomial|||Primary endpoint 1 was evaluated by performing an exact, binomial test comparing the observed proportion (overall complication-free rate at 6 months) to the performance goal of 90.0%, with Type I error (alpha) of 0.025 and power of 80%. The lower, two-sided 95% confidence bound for the overall complication-free rate must be greater than 90.0%.||||<0.0001
71021063|NCT02290028|141549823|SUPERIORITY||||||=|0.002|||||||Exact, binomial|||Primary endpoint 2 was evaluated by performing an exact, binomial test comparing an observed proportion (rate of acceptable LV pacing thresholds at the permanently programmed pacing vector at 3 months) to 88%, with Type I error (alpha) of 0.025 and power of 80%. The lower, two-sided 95% confidence bound for the percentage of subjects with an acceptable LV pacing threshold in the permanently programmed pacing vector must be greater than 88.0%.||||=0.002
71053631|NCT04715932|141611365|SUPERIORITY||Odds Ratio (OR)|1.38||||0.344|TWO_SIDED|95.0|0.71|2.68|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.68|0.71|0.3440
71053632|NCT04715932|141611366|SUPERIORITY||Odds Ratio (OR)|1.22||||0.5968|TWO_SIDED|95.0|0.58|2.56|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.56|0.58|0.5968
71053633|NCT04715932|141611367|SUPERIORITY||Odds Ratio (OR)|1.52||||0.362|TWO_SIDED|95.0|0.62|3.76|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.76|0.62|0.3620
71053634|NCT04715932|141611368|SUPERIORITY||Odds Ratio (OR)|1.97||||0.0875|TWO_SIDED|95.0|0.91|4.27|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||4.27|0.91|0.0875
71053635|NCT04715932|141611369|SUPERIORITY||Odds Ratio (OR)|0.91||||0.8397|TWO_SIDED|95.0|0.36|2.32|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.32|0.36|0.8397
71053636|NCT04715932|141611370|SUPERIORITY||Odds Ratio (OR)|1.36||||0.6265|TWO_SIDED|95.0|0.4|4.65|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||4.65|0.40|0.6265
71053637|NCT04715932|141611371|SUPERIORITY||Odds Ratio (OR)|1.21||||0.8528|TWO_SIDED|95.0|0.16|8.91|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||8.91|0.16|0.8528
71053638|NCT04715932|141611372|SUPERIORITY||Odds Ratio (OR)|1.34||||0.2983|TWO_SIDED|95.0|0.77|2.35|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.35|0.77|0.2983
71053639|NCT04715932|141611373|SUPERIORITY||Odds Ratio (OR)|1.19||||0.5611|TWO_SIDED|95.0|0.66|2.16|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.16|0.66|0.5611
71053640|NCT04715932|141611374|SUPERIORITY||Odds Ratio (OR)|1.29||||0.4643|TWO_SIDED|95.0|0.65|2.58|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.58|0.65|0.4643
71053641|NCT04715932|141611375|SUPERIORITY||Odds Ratio (OR)|1.38||||0.5063|TWO_SIDED|95.0|0.53|3.62|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.62|0.53|0.5063
71053642|NCT04715932|141611376|SUPERIORITY||Odds Ratio (OR)|1.41||||0.2292|TWO_SIDED|95.0|0.8|2.47|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.47|0.80|0.2292
71053643|NCT04715932|141611377|SUPERIORITY||Odds Ratio (OR)|1.16||||0.6097|TWO_SIDED|95.0|0.65|2.07|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.07|0.65|0.6097
71053644|NCT04715932|141611378|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8389|TWO_SIDED|95.0|0.54|2.16|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.16|0.54|0.8389
71053645|NCT04715932|141611379|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9764|TWO_SIDED|95.0|0.45|2.17|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.17|0.45|0.9764
71106452|NCT01405196|141719783|SUPERIORITY||LS Mean difference|-2.64|||||TWO_SIDED|90.0|-9.61|4.32||||||Week 20: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||4.32|-9.61|
71053646|NCT04715932|141611380|SUPERIORITY||Odds Ratio (OR)|0.8||||0.4403|TWO_SIDED|95.0|0.46|1.4|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.40|0.46|0.4403
71053647|NCT04715932|141611381|SUPERIORITY||Odds Ratio (OR)|0.79||||0.5112|TWO_SIDED|95.0|0.39|1.6|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.60|0.39|0.5112
71053648|NCT04715932|141611382|SUPERIORITY||Odds Ratio (OR)|1.04||||0.9306|TWO_SIDED|95.0|0.46|2.36|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.36|0.46|0.9306
71053649|NCT04715932|141611383|SUPERIORITY||Odds Ratio (OR)|0.73||||0.6046|TWO_SIDED|95.0|0.23|2.36|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.36|0.23|0.6046
71053650|NCT04715932|141611384|SUPERIORITY||Odds Ratio (OR)|1.15||||0.6963|TWO_SIDED|95.0|0.57|2.34|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.34|0.57|0.6963
71106453|NCT01405196|141719783|SUPERIORITY||LS Mean difference|2.66|||||TWO_SIDED|90.0|-4.48|9.8||||||Week 24: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||9.80|-4.48|
71021064|NCT02290028|141549824|SUPERIORITY|||||||||||||||||Primary endpoint 3 will be evaluated by performing an exact, binomial test comparing the observed proportion (overall complication-free rate at 5 years) to the performance goal of 92.5%, with Type I error (alpha) of 0.025 and power of 80%. The lower, two-sided 95% confidence bound for the overall complication-free rate must be greater than 92.5%|On September 24, 2019, BIOTRONIK received FDA approval to transition the ongoing Sentus Post Approval Registry to a new EP PASSION real-world data methodology. As of study closure, the number of subjects with complete data required to perform the hypothesis test was not met. Therefore, this outcome measure was not analyzed.|||
71021065|NCT03202511|141549833|EQUIVALENCE|0.8 to 1.25 equivalence margin was used.|Geometric Mean Ratio|1.61|||||TWO_SIDED|90.0|1.47|1.77||||||||1.77|1.47|
71021066|NCT03202511|141549834|EQUIVALENCE|80 to 125% equivalence margin was used.|Geometric Mean Ratio|77.4|||||TWO_SIDED|90.0|61.4|97.6||||||||97.6|61.4|
71021067|NCT00289731|141549843|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two treatment groups (Twinrix Group minus Engerix-B+Havrix Group), in terms of seropositivity rates for anti-HAV antibody, being - 10%.|Difference in seropositivity rate|-1.66|||||TWO_SIDED|95.0|-5.34|1.48||||||Difference in seropositivity rates against hepatitis A virus (HAV) antigen: To demonstrate that the immunogenicity of Twinrix vaccine (Twinrix Group) administered at Months 0, 1 and 6 was non-inferior to that of separately administered monovalent vaccines Engerix-B at Months 0, 1 and 6 and Havrix at Months 0 and 6 (Engerix-B+Havrix Group), in terms of anti-HAV seropositivity rates, at Month 7.||1.48|-5.34|
71021068|NCT00289731|141549843|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two treatment groups (Twinrix Group minus HB VAX PRO+Vaqta Group), in terms of seropositivity rates for anti-HAV antibody, being - 10%.|Difference in seropositivity rate|-1.63|||||TWO_SIDED|95.0|-5.31|1.6||||||Difference in seropositivity rates against hepatitis A virus (HAV) antigen: To demonstrate that the immunogenicity of Twinrix vaccine (Twinrix Group) administered at Months 0, 1 and 6 was non-inferior to that of separately administered monovalent vaccines HB VAX PRO at Months 0, 1 and 6 and Vaqta at Months 0 and 6 (HB VAX PRO+Vaqta Group), in terms of anti-HAV seropositivity rates, at Month 7.||1.60|-5.31|
71053651|NCT04715932|141611385|SUPERIORITY||Odds Ratio (OR)|0.65||||0.425|TWO_SIDED|95.0|0.22|1.88|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.88|0.22|0.4250
71053652|NCT04715932|141611386|SUPERIORITY||Odds Ratio (OR)|1.12||||0.8797|TWO_SIDED|95.0|0.27|4.65|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||4.65|0.27|0.8797
71053653|NCT04715932|141611387|SUPERIORITY||Odds Ratio (OR)|3.71||||0.2634|TWO_SIDED|95.0|0.37|37.03|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||37.03|0.37|0.2634
71053654|NCT04715932|141611388|SUPERIORITY||Odds Ratio (OR)|1.5||||0.271|TWO_SIDED|95.0|0.73|3.06|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.06|0.73|0.2710
71053655|NCT04715932|141611389|SUPERIORITY||Odds Ratio (OR)|1.82||||0.1748|TWO_SIDED|95.0|0.77|4.3|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||4.30|0.77|0.1748
71053656|NCT04715932|141611390|SUPERIORITY||Odds Ratio (OR)|1.12||||0.8513|TWO_SIDED|95.0|0.34|3.63|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.63|0.34|0.8513
71053657|NCT04715932|141611391|SUPERIORITY||Odds Ratio (OR)|1.21||||0.7906|TWO_SIDED|95.0|0.29|5.07|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||5.07|0.29|0.7906
71053658|NCT02740699|141611439|SUPERIORITY|||||||0.0256|||||||Wilcoxon Signed Rank Tests|||||||0.0256
71053659|NCT02740699|141611440|SUPERIORITY|||||||0.0254|||||||Wilcoxon Signed Rank Tests|||||||0.0254
71053660|NCT02740699|141611441|SUPERIORITY|||||||0.58|||||||Regression, Linear|||||||0.58
71053661|NCT02740699|141611442|SUPERIORITY|||||||0.06|||||||Regression, Linear|||||||0.06
71021069|NCT00289731|141549844|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two treatment groups (Twinrix Group minus Engerix-B+Havrix Group), in terms of seroprotection rates for anti-HBs antibody, being - 10%.|Difference in seroprotection rate|12.04|||||TWO_SIDED|95.0|4.97|19.35||||||Difference in seroprotection rates against hepatitis B surface (HBs) antigen: To demonstrate that the immunogenicity of Twinrix vaccine (Twinrix Group) administered at Months 0, 1 and 6 was non-inferior to that of separately administered monovalent vaccines Engerix-B at Months 0, 1 and 6 and Havrix at Months 0 and 6 (Engerix-B+Havrix Group), in terms of anti-HBs seroprotection rates, at Month 7.||19.35|4.97|
71053662|NCT02740699|141611443|SUPERIORITY|||||||0.69|||||||Regression, Linear|||||||0.69
71053663|NCT02740699|141611444|SUPERIORITY|||||||0.006|||||||Regression, Linear|||||||0.006
71053664|NCT03783039|141611447|NON_INFERIORITY|10% margin|Risk Difference (RD)|0.0605|||<|0.0001|ONE_SIDED|97.5|-0.0189|||Testing whether the group difference in proportion of successes is \>-0.1 (Test Group - Control Group)|Farrington-Manning method||||||-0.0189|<0.0001
71053665|NCT03783039|141611448|OTHER||Difference in proportion of successes|0.0992|||||TWO_SIDED|95.0|0.0078|0.1906|||Farrington-Manning Method|Difference in proportion of successes (Test Group - Control Group)||||0.1906|0.0078|
71053666|NCT03783039|141611449|OTHER||Difference in proportion of successes|0.0275|||||TWO_SIDED|95.0|-0.0312|0.0863|||Farrington-Manning Method|Difference in proportion of successes (Test Group - Control Group)||||0.0863|-0.0312|
71053667|NCT00918138|141611461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|STANDARD_ERROR_OF_MEAN|7.01||0.1278|TWO_SIDED|95.0|-24.8|3.2||Comparison between saxagliptin 5 mg + metformin 1500 mg and metformin 2000 mg significant at alpha =0.05 according to sequential testing procedure|ANCOVA|Change from baseline to week 4 was analyzed with ANCOVA including treatment group, baseline value and country in the model|Estimate = adjusted mean change for saxagliptin 5 mg + metformin 1500 mg - adjusted mean change for metformin 2000 mg|With at least 36 participants per treatment group (72 total), there is 90% power to detect a difference of 18 mg/dL between the two treatment groups. Assuming approximately 20% of participants will discontinue without any valid post-randomization assessment at Week 4, a total of 90 participants (45 participants per treatment group) needed to be randomized.||3.2|-24.8|0.1278
71053668|NCT00918138|141611462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.1|STANDARD_ERROR_OF_MEAN|11.8|||TWO_SIDED|95.0|-54.6|-7.7||Comparison between saxagliptin 5 mg + metformin 1500 mg and metformin 2000 mg significant at alpha =0.05 according to sequential testing procedure.|ANCOVA|Change from baseline to week 4 was analyzed with ANCOVA including treatment group, baseline value and country in the model|Estimate = adjusted mean change for saxagliptin 5 mg + metformin 1500 mg - adjusted mean change for metformin 2000 mg.|||-7.7|-54.6|
71053669|NCT00918138|141611463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7|STANDARD_ERROR_OF_MEAN|7.18|||TWO_SIDED|95.0|-20.0|8.5||Comparison between saxagliptin 5 mg + metformin 1500 mg and metformin 2000 mg significant at alpha =0.05 according to sequential testing procedure.|ANCOVA|Change from baseline to week 4 was analyzed with ANCOVA including treatment group, baseline value and country in the model.|Estimate = adjusted mean change for saxagliptin 5 mg + metformin 1500 mg - adjusted mean change for metformin 2000 mg|||8.5|-20.0|
71053670|NCT01955837|141611468|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.035|TWO_SIDED|95.0|0.62|0.99|||Log Rank|||||0.99|0.62|0.035
71053671|NCT01955837|141611469|SUPERIORITY||Hazard Ratio (HR)|0.43|||<|0.001|TWO_SIDED|95.0|0.34|0.54|||Log Rank|||||0.54|0.34|<0.001
71053672|NCT01955837|141611470|SUPERIORITY||Hazard Ratio (HR)|0.46|||<|0.001|TWO_SIDED|95.0|0.37|0.58|||Log Rank|||||0.58|0.37|<0.001
71053673|NCT01955837|141611471|SUPERIORITY||Difference in ORR|1.1||||0.554|TWO_SIDED|95.0|-0.1|2.4|||Fisher Exact|||||2.4|-0.1|0.554
71053674|NCT01955837|141611472|SUPERIORITY||Difference in DCR|29.4|||<|0.001|TWO_SIDED|95.0|20.9|38.0|||Fisher Exact|||||38.0|20.9|<0.001
71053675|NCT01955837|141611473|SUPERIORITY||Odds Ratio (OR)|29.4|||<|0.001|TWO_SIDED|95.0|20.9|38.0|||Fisher Exact|||||38.0|20.9|<0.001
71053676|NCT01955837|141611476|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.083|TWO_SIDED|95.0|0.57|1.04|||Log Rank|||||1.04|0.57|0.083
71053677|NCT01955837|141611477|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.228|TWO_SIDED|95.0|0.57|1.2|||Log Rank|||||1.20|0.57|0.228
70932618|NCT00712179|141364892|SUPERIORITY_OR_OTHER|||||||0.94|||||||Mixed Models Analysis|||Null Hypothesis: Modification of paretic leg loading and movement by the therapist will have significant effect on EMG pattern of non-paretic leg.||||0.94
70932619|NCT00065182|141364893|SUPERIORITY||Hazard Ratio (HR)|1.007||||0.946|TWO_SIDED|95.0|0.813|1.248|||Log Rank||Unadjusted hazard ratio.|||1.248|0.813|0.9460
70932620|NCT00065182|141364893|SUPERIORITY||Hazard Ratio (HR)|0.977|||||TWO_SIDED|95.0|0.788|1.21|||||Adjusted hazard ratio.|||1.210|0.788|
70932621|NCT00366249|141364934|NON_INFERIORITY_OR_EQUIVALENCE|Statistical analysis tested for non-inferiority. Non-inferiority margin is -10%.|Mehrotra and Railker|-5.5||||||95.0|-11.0|0.1|||||Adjusted for Perfusion, Extent, Depth/tissue loss, Infection, and Sensation (PEDIS) score|Analysis provided for Cure||0.1|-11.0|
70932622|NCT00366249|141364936|NON_INFERIORITY_OR_EQUIVALENCE|Statistical analysis tested for non-inferiority. Non-inferiority margin is -10%.|Mehrotra and Railkar|-6.7||||||95.0|-12.3|-1.1|||||Adjusted for PEDIS score|Analysis provided for Cure||-1.1|-12.3|
70932623|NCT00366249|141364938|NON_INFERIORITY_OR_EQUIVALENCE|Statistical analysis tested for non-inferiority. Non-inferiority margin is -10%.|Mehrotra and Railkar|-6.3||||||95.0|-13.6|1.0|||||Adjusted for PEDIS score|||1.0|-13.6|
70932624|NCT01185600|141364961|SUPERIORITY_OR_OTHER|||||||0.142|||||||Fisher Exact|||||||0.142
71021070|NCT00289731|141549844|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two treatment groups (Twinrix Group minus HB VAX PRO+Vaqta Group), in terms of seroprotection rates for anti-HBs antibody, being - 15%.|Difference in seroprotection rates|20.69|||||TWO_SIDED|95.0|12.92|28.62||||||Difference in seropositivity rates against hepatitis B surface (HBs) antigen: To demonstrate that the immunogenicity of Twinrix vaccine (Twinrix Group) administered at Months 0, 1 and 6 was non-inferior to that of separately administered monovalent vaccines HB VAX PRO at Months 0, 1 and 6 and Vaqta at Months 0 and 6 (HB VAX PRO+Vaqta Group), in terms of anti-HBs seroprotection rates, at Month 7.||28.62|12.92|
70932625|NCT01185600|141364962|SUPERIORITY_OR_OTHER|||||||0.0391|||||||Fisher Exact|||||||0.0391
71021071|NCT04378010|141549873|OTHER||LS mean difference|1.88|STANDARD_ERROR_OF_MEAN|1.788||0.454|TWO_SIDED|95.0|-3.479|7.239|||Mixed model repeated measures|||||7.239|-3.479|0.454
71021072|NCT04378010|141549873|OTHER||LS mean difference|-0.439|STANDARD_ERROR_OF_MEAN|1.553||0.848|TWO_SIDED|95.0|-5.458|4.579|||Mixed model repeated measures|||||4.579|-5.458|0.848
71021073|NCT04378010|141549884|OTHER||LS mean difference|-11.718|STANDARD_ERROR_OF_MEAN|7.052||0.114|TWO_SIDED|95.0|-26.342|2.906|||ANCOVA|||||2.906|-26.342|0.114
70932626|NCT01185600|141364963|SUPERIORITY_OR_OTHER|||||||0.372|||||||Fisher Exact|||||||0.372
70932627|NCT01185600|141364964|SUPERIORITY_OR_OTHER|||||||0.1007|||||||t-test, 2 sided|||||||0.1007
70932628|NCT01185600|141364965|SUPERIORITY_OR_OTHER|||||||0.0964|||||||t-test, 2 sided|||||||0.0964
70932629|NCT01185600|141364966|SUPERIORITY_OR_OTHER|||||||0.1739|||||||t-test, 2 sided|||||||0.1739
71021074|NCT04378010|141549884|OTHER||LS mean difference|-11.261|STANDARD_ERROR_OF_MEAN|6.879||0.099|TWO_SIDED|95.0|-24.723|2.2|||ANCOVA|||||2.200|-24.723|0.099
71021075|NCT04378010|141549885|OTHER||LS mean difference|1.05|STANDARD_ERROR_OF_MEAN|0.331||0.003|TWO_SIDED|95.0|0.365|1.736|||ANCOVA|||||1.736|0.365|0.003
71021076|NCT04378010|141549885|OTHER||LS mean difference|0.591|STANDARD_ERROR_OF_MEAN|0.315||0.064|TWO_SIDED|95.0|-0.035|1.216|||ANCOVA|||||1.216|-0.035|0.064
71021077|NCT04378010|141549889|OTHER||LS mean difference|12.986|STANDARD_ERROR_OF_MEAN|5.472||0.04|TWO_SIDED|95.0|0.608|25.363|||Mixed model repeated measures|||||25.363|0.608|0.040
71106454|NCT01405196|141719784|SUPERIORITY||LS mean difference|3.63||||||90.0|-2.56|9.83||||||Week 4: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||9.83|-2.56|
70932630|NCT01185600|141364967|SUPERIORITY_OR_OTHER|||||||0.7205|||||||t-test, 1 sided|||||||0.7205
70932631|NCT01185600|141364968|SUPERIORITY_OR_OTHER||Negative Binomial|1.64||||0.0176|TWO_SIDED|95.0|1.06|2.55|||t-test, 2 sided||"Using Negative Binomial Regression the following ratio and corresponding 95% CI were obtained:~(# of AE's, Unwashed Group / (# of AE's, Washed Group) = 1.64 95% C.I. = \[1.06 - 2.55\]"|||2.55|1.06|0.0176
71021078|NCT04378010|141549889|OTHER||LS mean difference|7.211|STANDARD_ERROR_OF_MEAN|5.724||0.242|TWO_SIDED|95.0|-4.997|19.418|||Mixed model repeated measures|||||19.418|-4.997|0.242
71021079|NCT00747747|141549920|SUPERIORITY_OR_OTHER||Frequency|0.0|||<|0.05|||||||Chi-squared|||Null hypothesis: no difference among groups.||||<0.05
71021080|NCT00747747|141549925|SUPERIORITY_OR_OTHER||Frequency|0.0|||<|0.05|||||||Chi-squared|||Null hypotheis: no difference among the groups.||||<0.05
71021081|NCT02314520|141549940|SUPERIORITY|||||||0.271||||||0.05 is the threshold for significance for this primary outcome.|Fisher Exact|||||||0.271
71021082|NCT00467818|141549944|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||t-test, 2 sided|||||||1.0
71021083|NCT00467818|141549945|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.1|TWO_SIDED||||||Mixed Models Analysis|||||||0.10
71021084|NCT00467818|141549947|SUPERIORITY||Mean Difference (Final Values)|0.5|||<|0.5|TWO_SIDED||||||Mixed Models Analysis|||||||<0.5
71021085|NCT00467818|141549948|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.5|TWO_SIDED||||||Mixed Models Analysis|||||||0.5
71021086|NCT02143947|141549962|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||Mixed Models Analysis|||||||> .10
71021087|NCT02143947|141549963|SUPERIORITY_OR_OTHER||||||=|0.036|TWO_SIDED||||||Mixed Models Analysis|||||||= .036
70932632|NCT02941549|141364969|SUPERIORITY||LS Mean Difference|-6.9||||0.5946|TWO_SIDED|95.0|-34.5|20.7|||ANCOVA|||||20.7|-34.5|0.5946
70932633|NCT02941549|141364969|SUPERIORITY||LS Mean Difference|-10.1||||0.7309|TWO_SIDED|95.0|-36.9|16.8|||ANCOVA|||||16.8|-36.9|0.7309
70932634|NCT02941549|141364970|SUPERIORITY||LS Mean Difference|-1.308||||0.0763|TWO_SIDED|95.0|-2.11|-0.51|||ANCOVA|||||-0.51|-2.11|0.0763
70932635|NCT02941549|141364970|SUPERIORITY||LS Mean Difference|-0.727||||0.0058|TWO_SIDED|95.0|-1.554|0.1|||ANCOVA|||||0.100|-1.554|0.0058
70932636|NCT03577106|141365015|OTHER||||||<|0.005||||||t(20)=3.3, p\<0.005|paired t-test|||Mean difference using a paired t-test||||<0.005
70932637|NCT03601715|141365019|SUPERIORITY||||||<|0.05||||||Bonferroni post-hoc tests.|ANOVA|||Based on a pilot test with eight subjects, we calculated that we would need 18 subjects to give 90% power to detect the most efficient arrangement with a α level of .05. Considering losses to follow up , we increased the sample size by 10%.|Effect size was calculated through partial eta squared and correlated using Cohen index (.1 to .3 as small, .3 to .5 as medium, and over .5 as large).|||<0.05
70932638|NCT03601715|141365020|SUPERIORITY||||||<|0.05||||||Bonferroni post-hoc tests.|ANOVA|||Based on a pilot test with eight subjects, we calculated that we would need 18 subjects to give 90% power to detect the most efficient arrangement with a α level of .05. Considering losses to follow up , we increased the sample size by 10%.|Effect size was calculated through partial eta squared and correlated using Cohen index (.1 to .3 as small, .3 to .5 as medium, and over .5 as large).|||<0.05
70941631|NCT04748445|141383934|OTHER||Slope|5.026|STANDARD_ERROR_OF_MEAN|5.176||0.9228|TWO_SIDED|90.0|-8.074|9.08|||Mixed Models Analysis|||EE\_MFCC mean 13 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-2. For estimated value it was 10\^-3).||9.080|-8.074|0.9228
71106455|NCT01405196|141719784|SUPERIORITY||LS mean difference|-2.02||||||90.0|-8.21|4.18||||||Week 8: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||4.18|-8.21|
71106456|NCT01405196|141719784|SUPERIORITY||LS mean difference|2.62|||||TWO_SIDED|90.0|-3.57|8.82||||||Week 12: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||8.82|-3.57|
71106457|NCT01405196|141719784|SUPERIORITY||LS mean difference|1.69|||||TWO_SIDED|90.0|-4.51|7.88||||||Week 16: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||7.88|-4.51|
71106458|NCT01405196|141719784|SUPERIORITY||LS mean difference|4.59|||||TWO_SIDED|90.0|-1.61|10.79||||||Week 20: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||10.79|-1.61|
71106459|NCT01405196|141719784|SUPERIORITY||LS mean difference|3.95||||||90.0|-2.24|10.15||||||Week 24: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||10.15|-2.24|
71106460|NCT01405196|141719784|SUPERIORITY||LS mean difference|1.92||||||90.0|-4.17|8.01||||||Week 4: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||8.01|-4.17|
71106461|NCT01405196|141719784|SUPERIORITY||LS mean difference|-4.2||||||90.0|-10.25|1.85||||||Week 8: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||1.85|-10.25|
71106462|NCT01405196|141719784|SUPERIORITY||LS mean difference|1.5|||||TWO_SIDED|90.0|-4.56|7.55||||||Week 16: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||7.55|-4.56|
71106463|NCT01405196|141719784|SUPERIORITY||LS mean difference|0.1|||||TWO_SIDED|90.0|-5.96|6.15||||||Week 20: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||6.15|-5.96|
71106464|NCT01405196|141719784|SUPERIORITY||LS mean difference|-0.34|||||TWO_SIDED|90.0|-6.39|5.71||||||Week 24: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||5.71|-6.39|
71106465|NCT01405196|141719784|SUPERIORITY||LS mean difference|-2.34|||||TWO_SIDED|90.0|-8.39|3.71||||||Week 12: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||3.71|-8.39|
71106466|NCT01405196|141719786|SUPERIORITY||LS mean difference|0.53|||||TWO_SIDED|90.0|-2.53|3.59||||||MCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.59|-2.53|
70932639|NCT03601715|141365021|SUPERIORITY||||||<|0.05||||||Bonferroni post-hoc tests.|ANOVA|||Based on a pilot test with eight subjects, we calculated that we would need 18 subjects to give 90% power to detect the most efficient arrangement with a α level of .05. Considering losses to follow up , we increased the sample size by 10%.|Effect size was calculated through partial eta squared and correlated using Cohen index (.1 to .3 as small, .3 to .5 as medium, and over .5 as large).|||<0.05
70932640|NCT00918333|141365024|SUPERIORITY_OR_OTHER_LEGACY||Maximum Tolerated Dose (mg)|40.0|||||TWO_SIDED|||||||||||||
71053678|NCT01955837|141611478|SUPERIORITY||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.32|0.59||||||||0.59|0.32|
71053679|NCT01955837|141611479|SUPERIORITY||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.31|0.65||||||||0.65|0.31|
71053680|NCT00552578|141611480|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.17||||0.523||95.0|0.0098|2.8215|||Fisher Exact|||Intent to treat||2.8215|0.0098|0.523
71053681|NCT00552578|141611482|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||No adjustment|Fisher Exact|||Fisher exact test was used and tested the hypothesis that neither group would be more likely to complete the study protocol.||||0.015
71053682|NCT04228783|141611491|EQUIVALENCE|An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.|Ratio of GMCs|0.9|||||TWO_SIDED|95.0|0.8|1.1||||||||1.1|0.8|
71053683|NCT04228783|141611491|EQUIVALENCE|An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.|Ratio of GMCs|0.9|||||TWO_SIDED|95.0|0.8|1.1||||||||1.1|0.8|
70932641|NCT01500200|141365055|SUPERIORITY|||||||0.014||||||Hypothesis tests were two-sided with an alpha of 0.5.|Mixed Models Analysis|ALKS 5461 was compared to PBO using stage-specific MMRM for change from Baseline. Model-derived estimates were combined using pre-specified weights.||Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified weights (0.6/0.4 for Stage 1/Stage 2). Within each stage ALKS 5461 2mg/2mg was compared to placebo (i.e., ALKS 5461 2mg/2mg S1 vs Placebo S1; and ALKS 5461 2mg/2mg S2 vs Placebo S2.||||0.014
71053684|NCT04228783|141611491|EQUIVALENCE|An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.|Ratio of GMCs|1.0|||||TWO_SIDED|95.0|0.9|1.2||||||||1.2|0.9|
71053685|NCT04228783|141611492|EQUIVALENCE|An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.|Ratio of GMCs|1.0|||||TWO_SIDED|95.0|0.8|1.2||||||||1.2|0.8|
71053686|NCT04228783|141611492|EQUIVALENCE|An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.|Ratio of GMCs|1.0|||||TWO_SIDED|95.0|0.8|1.3||||||||1.3|0.8|
71053687|NCT04228783|141611492|EQUIVALENCE|An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.|Ratio of GMCs|1.0|||||TWO_SIDED|95.0|0.8|1.3||||||||1.3|0.8|
71053688|NCT00626392|141611497|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||No adjustments were made for multiple comparisons. P-values \<= 0.05 were reported as statistically significant.|Cochran-Mantel-Haenszel|||||||0.010
71053689|NCT03151811|141611505|SUPERIORITY|||||||0.0311|||||||Log Rank|||||||0.0311
71053690|NCT01739348|141611513|SUPERIORITY||Difference in Least Squares Mean|0.2||||0.6287|TWO_SIDED|97.51|-0.9|1.3|||Longitudinal ANCOVA|||||1.3|-0.9|0.6287
71053691|NCT01739348|141611513|SUPERIORITY||Difference in Least Squares Mean|0.4||||0.4625|TWO_SIDED|97.51|-0.8|1.5|||Longitudinal ANCOVA|||||1.5|-0.8|0.4625
71053692|NCT01739348|141611514|SUPERIORITY||Difference in Least Squares Means|0.5||||0.4925|TWO_SIDED|97.51|-1.1|2.1|||Longitudinal ANCOVA|||||2.1|-1.1|0.4925
71053693|NCT01739348|141611514|SUPERIORITY||Difference in Least Squares Means|0.7||||0.3221|TWO_SIDED|97.51|-0.9|2.3|||Longitudinal ANCOVA|||||2.3|-0.9|0.3221
71053694|NCT01739348|141611521|SUPERIORITY||Difference in Least Squares Means|0.0||||0.8426|TWO_SIDED|97.51|-0.4|0.3|||Longitudinal ANCOVA|||||0.3|-0.4|0.8426
71053695|NCT01739348|141611521|SUPERIORITY||Difference in Least Squares Means|0.0||||0.8264|TWO_SIDED|97.51|-0.3|0.4|||Longitudinal ANCOVA|||||0.4|-0.3|0.8264
71053696|NCT01739348|141611522|SUPERIORITY||Difference in Least Squares Means|-0.6||||0.0005|TWO_SIDED|97.51|-1.0|-0.2|||Longitudinal ANCOVA|||||-0.2|-1.0|0.0005
71053697|NCT01739348|141611522|SUPERIORITY||Difference in Least Squares Means|-0.7||||0.0002|TWO_SIDED|97.51|-1.1|-0.3|||Longitudinal ANCOVA|||||-0.3|-1.1|0.0002
71053698|NCT01739348|141611523|SUPERIORITY||Ratio of Fold Change from Baseline|0.95||||0.2138|TWO_SIDED|95.0|0.87|1.04|||Longitudinal ANCOVA|||||1.04|0.87|0.2138
71053699|NCT01739348|141611523|SUPERIORITY||Ratio of Fold Change from Baseline|0.97||||0.433|TWO_SIDED|95.0|0.9|1.05|||Longitudinal ANCOVA|||||1.05|0.90|0.4330
71053700|NCT01739348|141611524|SUPERIORITY||Difference in Least Squares Means|-0.03||||0.0066|TWO_SIDED|95.0|-0.05|0.0|||Longitudinal ANCOVA|||||0.00|-0.05|0.0066
71053701|NCT01739348|141611524|SUPERIORITY||Difference in Least Squares Means|-0.04|||<|0.0001|TWO_SIDED|95.0|-0.06|-0.02|||Longitudinal ANCOVA|||||-0.02|-0.06|<0.0001
71053702|NCT01739348|141611526|SUPERIORITY||Difference in Least Squares Means|0.7||||0.2949|TWO_SIDED|95.0|-0.6|2.1|||Longitudinal ANCOVA|||||2.1|-0.6|0.2949
71053703|NCT01739348|141611526|SUPERIORITY||Difference in Least Squares Means|1.1||||0.1372|TWO_SIDED|95.0|-0.4|2.6|||Longitudinal ANCOVA|||||2.6|-0.4|0.1372
71053704|NCT01739348|141611527|SUPERIORITY||Difference in Least Squares Means|0.2||||0.4721|TWO_SIDED|95.0|-0.3|0.7|||Longitudinal ANCOVA|||||0.7|-0.3|0.4721
71053705|NCT01739348|141611527|SUPERIORITY||Difference in Least Squares Means|0.5||||0.0599|TWO_SIDED|95.0|0.0|1.0|||Longitudinal ANCOVA|||||1.0|0.0|0.0599
71053706|NCT01447420|141611531|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||Chi-squared|Participants without measurement at the end of the 24 week untreated follow-up period were considered as non-responders.||IL28B Genotypes (CC, CT or TT)||||0.0007
71053707|NCT01447420|141611534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68|||||TWO_SIDED|95.0|0.69|4.14|||||Odds Ratio for SVR estimated from the logistic regression model.|Anemia after the first month of treatment vs No anemia||4.14|0.69|
71053708|NCT01447420|141611534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86|||||TWO_SIDED|95.0|0.28|2.59|||||Odds Ratio for SVR estimated from the logistic regression model.|Anemia in the first month of treatment vs No anemia||2.59|0.28|
71053709|NCT01447420|141611534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.45|||||TWO_SIDED|95.0|2.27|13.12|||||Odds Ratio for SVR estimated from the logistic regression model.|IL28B - CC vs CT||13.12|2.27|
71053710|NCT01447420|141611534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.03|||||TWO_SIDED|95.0|1.19|13.61|||||Odds Ratio for SVR estimated from the logistic regression model.|IL28B - CC vs TT||13.61|1.19|
71053711|NCT04562155|141611536|SUPERIORITY||||||=|0.0345||||||Adjusted p-value|MCP-Mod method|||Detection of dose-response: Emax model (ED50=30) Dose response relationship was assessed using the MCP-Mod method combining multiple comparison procedures (MCP) principles with modeling techniques. A generalized MCP approach (with adjustment for baseline cough count and geographic region) was applied to calculate the adjusted one-sided p-values of the contrast test. Pre-specified overall Type one error at alpha level of 0.1 (one-sided).||||= 0.0345
71053712|NCT04562155|141611536|SUPERIORITY||||||=|0.0376||||||Adjusted p-value|MCP-Mod method|||Detection of dose-response: Emax model (ED50=50) Dose response relationship was assessed using the MCP-Mod method combining multiple comparison procedures (MCP) principles with modeling techniques. A generalized MCP approach (with adjustment for baseline cough count and geographic region) was applied to calculate the adjusted one-sided p-values of the contrast test. Pre-specified overall Type one error at alpha level of 0.1 (one-sided).||||= 0.0376
71053713|NCT04562155|141611536|SUPERIORITY||||||=|0.0319||||||Adjusted p-value|MCP-Mod method|||Detection of dose-response: sigm. Emax model (ED50=30, h=3) sigm = sigmoidal h = hill parameter Dose response relationship was assessed using the MCP-Mod method combining multiple comparison procedures (MCP) principles with modeling techniques. A generalized MCP approach (with adjustment for baseline cough count and geographic region) was applied to calculate the adjusted one-sided p-values of the contrast test. Pre-specified overall Type one error at alpha level of 0.1 (one-sided).||||= 0.0319
71053714|NCT04562155|141611536|SUPERIORITY||||||=|0.0603||||||Adjusted p-value|MCP-Mod method|||Detection of dose-response: sigm. Emax model (ED50=60, h=5) sigm = sigmoidal h = hill parameter Dose response relationship was assessed using the MCP-Mod method combining multiple comparison procedures (MCP) principles with modeling techniques. A generalized MCP approach (with adjustment for baseline cough count and geographic region) was applied to calculate the adjusted one-sided p-values of the contrast test. Pre-specified overall Type one error at alpha level of 0.1 (one-sided).||||= 0.0603
71053715|NCT01158573|141611581|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Hypothesis that leptin levels in OA is not different from the other 3 groups.|ANOVA|||||||<0.0001
71053716|NCT01158573|141611582|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANOVA|||||||0.002
71053717|NCT01158573|141611583|SUPERIORITY_OR_OTHER|||||||0.725|||||||ANOVA|||||||0.725
71053718|NCT01158573|141611584|SUPERIORITY_OR_OTHER|||||||0.16|||||||ANOVA|||||||0.16
71053719|NCT00073021|141611628|SUPERIORITY_OR_OTHER||Difference in Success Rates|12.543||||0.0357|TWO_SIDED|95.0|0.96|24.12|||Chi-squared|||It was assumed that true rate of improvement for 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with 2-sided test, type I error of 0.05 (alpha = 0.05), and power of 80%, 120 patients with moderately active ulcerative colitis were required per group to complete the study.||24.12|0.96|0.0357
71053720|NCT00073021|141611629|SUPERIORITY_OR_OTHER||Difference Between Means|-0.5||||0.1594|TWO_SIDED|95.0|-1.28|0.21|||ANOVA|||||0.21|-1.28|0.1594
71053721|NCT00073021|141611629|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Compared to baseline|t-test, 2 sided|The 2-sample t-test will be used to examine the treatment effect.||||||<0.0001
71053722|NCT00073021|141611629|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Compared to baseline|t-test, 2 sided|Teh 2-sample t-test will be used to examine the treatment effect.||||||<0.0001
71053723|NCT00073021|141611630|SUPERIORITY_OR_OTHER||Difference in Success Rates|3.75||||0.5774|TWO_SIDED|95.0|-9.43|16.93|||Chi-squared|||||16.93|-9.43|0.5774
71053724|NCT00073021|141611631|SUPERIORITY_OR_OTHER||Difference in Success Rates|6.19||||0.2991|TWO_SIDED|95.0|-5.47|17.86|||Chi-squared|||||17.86|-5.47|0.2991
71053725|NCT00073021|141611632|SUPERIORITY_OR_OTHER||Difference in Success Rates|2.74||||0.6543|TWO_SIDED|95.0|-9.25|14.73|||Chi-squared|||||14.73|-9.25|0.6543
71053726|NCT00073021|141611633|SUPERIORITY_OR_OTHER||Difference in Success Rates|1.05||||0.8542|TWO_SIDED|95.0|-10.19|12.29|||Chi-squared|||||12.29|-10.19|0.8542
71053727|NCT00073021|141611634|SUPERIORITY_OR_OTHER||Difference in Success Rates|-0.96||||0.8859|TWO_SIDED|95.0|-14.09|12.17|||Chi-squared|||||12.17|-14.09|0.8859
71053728|NCT00073021|141611635|SUPERIORITY_OR_OTHER||Difference in Success Rates|9.73||||0.0758|TWO_SIDED|95.0|-0.94|20.4|||Chi-squared|||||20.40|-0.94|0.0758
71053729|NCT00073021|141611636|SUPERIORITY_OR_OTHER|||||||0.8308||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8308
71053730|NCT00073021|141611636|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||Compared to baseline|t-test, 2 sided|||||||<0.0001
71053731|NCT00073021|141611636|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Compared to baseline.|t-test, 2 sided|||||||<0.0001
71053732|NCT00073021|141611637|SUPERIORITY_OR_OTHER|||||||0.534||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5340
71053733|NCT00073021|141611637|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Compared to baseline|t-test, 2 sided|||||||<0.0001
71053734|NCT00073021|141611637|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Compared to baseline|t-test, 2 sided|||||||<0.0001
71053735|NCT00073021|141611638|SUPERIORITY_OR_OTHER||Difference in Success Rates|11.1||||0.0966|TWO_SIDED|95.0|-1.87|24.14|||Chi-squared|||||24.14|-1.87|0.0966
71053736|NCT00073021|141611639|SUPERIORITY_OR_OTHER||Difference in Success Rates|9.75||||0.1173|TWO_SIDED|95.0|-2.39|21.89|||Chi-squared|||||21.89|-2.39|0.1173
71053737|NCT02304458|141611664|OTHER|Maximum Tolerate Dose Level was determined by the rolling-6 design.|Maximum Tolerate Dose Level|3.0|||||TWO_SIDED||||||||Maximum Tolerate Dose Level is 3 mg/kg Nivolumab|||||
71053738|NCT02823652|141611678|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<.0001
71053739|NCT02823652|141611679|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||0.035
71053740|NCT02823652|141611680|SUPERIORITY|||||||0.312|||||||t-test, 2 sided|||||||0.312
71053741|NCT02823652|141611681|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
71053742|NCT02022748|141611696|OTHER||Ratio of Geometric Least Square Means|151.13|||||TWO_SIDED|90.0|112.03|203.86|||||Treatment H is the reference treatment.|||203.86|112.03|
71053743|NCT02022748|141611696|OTHER||Ratio of Geometric Least Square Means|161.38|||||TWO_SIDED|90.0|122.52|212.58|||||Treatment H is the reference treatment.|||212.58|122.52|
71106467|NCT01405196|141719786|SUPERIORITY||LS mean difference|-0.48|||||TWO_SIDED|90.0|-3.54|2.58||||||MCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.58|-3.54|
71106468|NCT01405196|141719786|SUPERIORITY||LS mean difference|1.28|||||TWO_SIDED|90.0|-1.78|4.34||||||MCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.34|-1.78|
71053744|NCT02022748|141611696|OTHER||Ratio of Geometric Least Square Means|90.1|||||TWO_SIDED|90.0|78.07|103.98|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment B is the reference treatment.|||103.98|78.07|
71053745|NCT02022748|141611697|OTHER||Ratio of Geometric Least Square Means|117.09|||||TWO_SIDED|90.0|84.51|162.22|||||Treatment H is the reference treatment.|||162.22|84.51|
71053746|NCT02022748|141611697|OTHER||Ratio of Geometric Least Square Means|136.27|||||TWO_SIDED|90.0|95.38|194.7|||||Treatment H is the reference treatment.|||194.70|95.38|
71053747|NCT02022748|141611697|OTHER||Ratio of Geometric Least Square Means|82.29|||||TWO_SIDED|90.0|68.43|98.96|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment B is the reference treatment.|||98.96|68.43|
71053748|NCT02022748|141611698|OTHER||Ratio of Geometric Least Square Means|137.75|||||TWO_SIDED|90.0|105.7|179.52|||||Treatment H is the reference treatment.|||179.52|105.70|
71053749|NCT02022748|141611698|OTHER||Ratio of Geometric Least Square Means|148.76|||||TWO_SIDED|90.0|115.07|192.32|||||Treatment H is the reference treatment.|||192.32|115.07|
71053750|NCT02022748|141611698|OTHER||Ratio of Geometric Least Square Means|90.35|||||TWO_SIDED|90.0|77.55|105.27|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment B is the reference treatment.|||105.27|77.55|
71053751|NCT02022748|141611699|OTHER||Ratio of Geometric Least Square Means|112.73|||||TWO_SIDED|90.0|88.61|143.42|||||Treatment H is the reference treatment.|||143.42|88.61|
71053752|NCT02022748|141611699|OTHER||Ratio of Geometric Least Square Means|114.37|||||TWO_SIDED|90.0|91.19|143.45|||||Treatment H is the reference treatment.|||143.45|91.19|
71053753|NCT02022748|141611699|OTHER||Ratio of Geometric Least Square Means|93.13|||||TWO_SIDED|90.0|80.31|108.0|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment B is the reference treatment.|||108.00|80.31|
71053754|NCT02022748|141611700|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|||||TWO_SIDED|90.0|-0.97|0.75|||||Treatment A - Treatment H.|||0.75|-0.97|
71053755|NCT02022748|141611700|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|||||TWO_SIDED|90.0|-0.96|1.52|||||Treatment B - Treatment H.|||1.52|-0.96|
71053756|NCT02022748|141611700|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-0.36|||||TWO_SIDED|90.0|-1.73|1.02|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment A - Treatment B.|||1.02|-1.73|
71053757|NCT02022748|141611701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.07|||||TWO_SIDED|90.0|-2.62|0.48|||||Treatment A - Treatment H.|||0.48|-2.62|
71053758|NCT02022748|141611701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.05|||||TWO_SIDED|90.0|-2.46|0.37|||||Treatment B - Treatment H.|||0.37|-2.46|
71053759|NCT02022748|141611701|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-0.5|||||TWO_SIDED|90.0|-1.27|0.27|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment A - Treatment B.|||0.27|-1.27|
71053760|NCT00372411|141611726|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.17||||0.08|TWO_SIDED|95.0|-0.23|4.58||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses|ANCOVA|Analysis is of change at 12 weeks minus baseline adjusted for the study site as a fixed effect, the Comorbidity Disease Index, and baseline FM value.||Because randomization to usual care was stopped after 15 months as specified by the protocol, comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||4.58|-0.23|0.08
71053761|NCT00372411|141611726|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.88||||0.02|TWO_SIDED|95.0|0.57|5.18||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||5.18|0.57|0.02
71053762|NCT00372411|141611726|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.92|TWO_SIDED|95.0|-2.94|2.65||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses|ANCOVA|Analysis is of change at 12 weeks minus baseline adjusted for the study site as a fixed effect, the Comorbidity Disease Index, and baseline FM value.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||2.65|-2.94|0.92
71053763|NCT00372411|141611726|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.58||||0.63|TWO_SIDED|95.0|-2.97|1.81||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||1.81|-2.97|0.63
71079510|NCT00482170|141666457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.33||0.928|TWO_SIDED|95.0|-0.67|0.61||Statistical testing, 2-sided, was done at 5% significance level.|ANOVA|||Week 12: Mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an unstructured correlation was used for the analysis.||0.61|-0.67|0.928
71021088|NCT02143947|141549964|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||Mixed Models Analysis|||||||> .10
71021089|NCT02143947|141549965|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||< .05
71021090|NCT01244815|141549966|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares (LS) Means|-3.2||||0.008|TWO_SIDED|95.0|-5.6|-0.8||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|Mixed Model for Repeated Measures (MMRM)|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.8|-5.6|0.008
71053764|NCT00372411|141611727|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.64||||0.009|TWO_SIDED|95.0|2.03|13.24||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses|ANCOVA|Analysis is change at 12 weeks minus baseline, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline SIS value.||Because randomization to usual care was stopped after 15 months as specified by the protocol, comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||13.24|2.03|0.009
71106469|NCT01405196|141719786|SUPERIORITY||LS mean difference|1.78|||||TWO_SIDED|90.0|-1.28|4.84||||||MCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.84|-1.28|
71106470|NCT01405196|141719786|SUPERIORITY||LS mean difference|1.2|||||TWO_SIDED|90.0|-1.86|4.26||||||MCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.26|-1.86|
71106471|NCT01405196|141719786|SUPERIORITY||LS mean difference|0.09|||||TWO_SIDED|90.0|-2.98|3.15||||||MCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.15|-2.98|
71053765|NCT00372411|141611727|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.95||||0.04|TWO_SIDED|95.0|0.34|11.56||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||11.56|0.34|0.04
71053766|NCT00372411|141611727|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.54||||0.81|TWO_SIDED|95.0|-3.87|4.94||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis is change at 12 weeks minus baseline, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline SIS value.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||4.94|-3.87|0.81
71053767|NCT00372411|141611727|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.19||||0.55|TWO_SIDED|95.0|-2.74|5.12||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||5.12|-2.74|0.55
71053768|NCT00372411|141611728|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.41||||0.22|TWO_SIDED|95.0|-11.52|2.7||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis is change at 12 weeks minus baseline adjusted for the study site as a fixed effect, the Comorbidity Disease Index, and baseline WMFT value.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||2.70|-11.52|0.22
71053769|NCT00372411|141611728|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.1||||0.005|TWO_SIDED|95.0|-13.61|-2.6||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||-2.60|-13.61|0.005
71053770|NCT00372411|141611728|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.93||||0.82|TWO_SIDED|95.0|-7.03|8.89||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis is change at 12 weeks minus baseline adjusted for the study site as a fixed effect, the Comorbidity Disease Index, and baseline WMFT value.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||8.89|-7.03|0.82
71053771|NCT00372411|141611728|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.13||||0.55|TWO_SIDED|95.0|-9.2|4.93||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||4.93|-9.20|0.55
71106472|NCT01405196|141719786|SUPERIORITY||LS mean difference|0.0|||||TWO_SIDED|90.0|-3.03|3.03||||||MCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.03|-3.03|
71106473|NCT01405196|141719786|SUPERIORITY||LS mean difference|-0.09|||||TWO_SIDED|90.0|-3.09|2.92||||||MCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.92|-3.09|
71021091|NCT01244815|141549966|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-5.3|||<|0.001|TWO_SIDED|95.0|-7.7|-2.9||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-2.9|-7.7|<0.001
71053772|NCT00372411|141611729|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.81||||0.08|TWO_SIDED|95.0|-1.73|0.11||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis of covariance at 12 weeks, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline value of the outcome.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||0.11|-1.73|0.08
70932642|NCT01500200|141365055|SUPERIORITY|||||||0.699||||||Hypothesis tests were two-sided with an alpha of 0.05.|Mixed Models Analysis|ALKS 5461 was compared to PBO using stage-specific MMRM for change from Baseline. Model-derived estimates were combined using pre-specified weights.||Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified weights (0.6/0.4 for Stage 1/Stage 2). Within each stage ALKS 5461 8mg/8mg was compared to placebo (i.e., ALKS 5461 8mg/8mg S1 vs Placebo S1; and ALKS 5461 8mg/8mg S2 vs Placebo S2.||||0.699
71106474|NCT01405196|141719786|SUPERIORITY||LS mean difference|-0.02|||||TWO_SIDED|90.0|-3.03|2.99||||||MCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.99|-3.03|
70932643|NCT03066609|141365105|SUPERIORITY||Odds Ratio (OR)|153.94|||<|0.0001|TWO_SIDED|95.0|54.02|438.67|||Regression, Logistic|||PASI 75||438.67|54.02|<0.0001
70932644|NCT03066609|141365105|SUPERIORITY||Odds Ratio (OR)|557.98|||<|0.0001|TWO_SIDED|95.0|187.2|1663.4|||Regression, Logistic|||PASI 75||1663.4|187.2|<0.0001
70932645|NCT03066609|141365106|SUPERIORITY||Odds Ratio (OR)|75.82|||<|0.0001|TWO_SIDED|95.0|25.81|222.72|||Regression, Logistic|||IGA||222.72|25.81|<0.0001
70932646|NCT03066609|141365106|SUPERIORITY||Odds Ratio (OR)|149.71|||<|0.0001|TWO_SIDED|95.0|51.83|432.42|||Regression, Logistic|||IGA||432.42|51.83|<0.0001
70932647|NCT03066609|141365107|SUPERIORITY||Odds Ratio (OR)|114.85|||<|0.0001|TWO_SIDED|95.0|26.94|489.59|||Regression, Logistic|||PASI 90||489.59|26.94|<0.0001
70932648|NCT03066609|141365107|SUPERIORITY||Odds Ratio (OR)|246.12|||<|0.0001|TWO_SIDED|95.0|58.41|1037.1|||Regression, Logistic|||PASI 90||1037.1|58.41|<0.0001
70932649|NCT01499849|141365141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9|||<|0.001|TWO_SIDED|95.0|1.3|2.7||To control for multiplicity, analyses were performed hierarchically. For the CR delayed the threshold for statistical significance was 0.05; no further adjustment for multiplicity were required for the primary endpoint.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.7|1.3|<0.001
70932650|NCT01499849|141365142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.005|TWO_SIDED|95.0|1.2|2.8||To control for multiplicity, analyses were performed hierarchically. CR-acute was tested only if the result for the primary endpoint, CR delayed, was statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.8|1.2|0.005
70932651|NCT01499849|141365143|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.001|TWO_SIDED|95.0|1.3|2.6||To control for multiplicity, analyses were performed hierarchically. CR overall was tested only if both CR delayed and CR acute were statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.6|1.3|0.001
70932652|NCT00811941|141365146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|STANDARD_ERROR_OF_MEAN|0.62||0.16|TWO_SIDED|95.0|-2.1|0.35|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 110 participants in the placebo group and 320 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. Null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-13); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."||0.35|-2.10|0.160
70932653|NCT00811941|141365147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47|STANDARD_ERROR_OF_MEAN|2.9||0.232|TWO_SIDED|95.0|-9.17|2.23|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 110 participants in the placebo group and 320 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. The null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-13); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."||2.23|-9.17|0.232
70932654|NCT00811941|141365148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.689|TWO_SIDED|95.0|0.59|1.41|||Adjusted Odds Ratio (OR) response|||The analysis of RSDRL used a logistic regression (LREG) model, with country, sex, Baseline DRL, and treatment as fixed effects, and missing values were imputed using individual-patient predicted values of TAC derived from the MMRM model.||1.41|0.59|0.689
70932655|NCT00811941|141365149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.09||0.046|TWO_SIDED|95.0|-0.37|0.0|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 104 participants in the placebo group and 306 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model; an unstructured covariance matrix was used.||-0.00|-0.37|0.046
70941632|NCT04748445|141383934|OTHER||Slope|0.08365|STANDARD_ERROR_OF_MEAN|2.873||0.0043|TWO_SIDED|90.0|0.03604|0.1313|||Mixed Models Analysis|||EE\_MFCC std 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1313|0.03604|0.0043
71106475|NCT01405196|141719786|SUPERIORITY||LS mean difference|-0.16|||||TWO_SIDED|90.0|-3.17|2.85||||||MCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.85|-3.17|
71106476|NCT01405196|141719786|SUPERIORITY||LS mean difference|-1.58|||||TWO_SIDED|90.0|-4.58|1.43||||||MCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||1.43|-4.58|
71053773|NCT00372411|141611729|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.84||||0.03|TWO_SIDED|95.0|-1.62|-0.06||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis of covariance at 12 weeks, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline value of the outcome.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||-0.06|-1.62|0.03
71021092|NCT01244815|141549966|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-6.2|||<|0.001|TWO_SIDED|95.0|-8.6|-3.8||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-3.8|-8.6|<0.001
71053774|NCT00372411|141611730|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.95|TWO_SIDED|95.0|-0.25|0.26||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis of covariance at 12 weeks, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline value of the outcome.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||0.26|-0.25|0.95
71053775|NCT00372411|141611730|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19||||0.1|TWO_SIDED|95.0|-0.42|0.04||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis of covariance at 12 weeks, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline value of the outcome.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||0.04|-0.42|0.10
71053776|NCT00631657|141611731|SUPERIORITY_OR_OTHER||Difference in Least Squares (LS) Means|48.7|||<|0.0001|TWO_SIDED|95.0|35.0|62.5|||ANCOVA||ANCOVA performed with fixed effects for treatment and (pooled) center as factors and baseline TST as covariate.|||62.5|35.0|<0.0001
71021093|NCT01244815|141549966|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-4.92|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 1 (Placebo\<2.5 mg=5.0 mg=10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 1. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||<0.0001
71021094|NCT01244815|141549966|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-4.87|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 2 (Placebo=2.5 mg\<5.0 mg=10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 2. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||<0.0001
71053777|NCT00631657|141611734|SUPERIORITY_OR_OTHER||Difference in LS Means|-4.9||||0.2145|TWO_SIDED|95.0|-12.6|2.8|||ANCOVA||ANCOVA performed with fixed effects for treatment and (pooled) center as factors and baseline SL as covariate.|||2.8|-12.6|0.2145
71053778|NCT00631657|141611735|SUPERIORITY_OR_OTHER||Difference in LS Means|-25.0|||<|0.0001|TWO_SIDED|95.0|-34.5|-15.4|||ANCOVA||ANCOVA performed with fixed effects for treatment and (pooled) center as factors and baseline WASO as covariate.|||-15.4|-34.5|<0.0001
71053779|NCT00699374|141611748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||0.9993|TWO_SIDED|95.0|1.14|1.5||One-sided p-value based on stratified log-rank test controlling the effects of geographic region, prior transarterial chemoembolization (TACE) and tumor invasion condition.|Log Rank|||||1.50|1.14|0.9993
71053780|NCT00699374|141611749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.8857|TWO_SIDED|95.0|0.99|1.3||One-sided p-value based on stratified log-rank test controlling the effects of geographic region, prior TACE, and tumor invasion condition|Log Rank|||||1.30|0.99|0.8857
71053781|NCT00699374|141611750|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.8459|TWO_SIDED|95.0|0.98|1.31||One-sided p-value based on stratified log-rank test controlling the effects of geographic region, prior TACE and tumor invasion condition|Log Rank|||||1.31|0.98|0.8459
71053782|NCT01853930|141611752|SUPERIORITY|The purpose of the superiority test is to show if laboratory based training is superior to an independent home-based training option.||||||0.876|||||||t-test, 2 sided|t= -0.157 df= 30||||||0.876
71077919|NCT02913105|141664399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.83|||<|0.0001|TWO_SIDED|90.0|0.79|0.88|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 28||0.88|0.79|<.0001
71077920|NCT02913105|141664399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.86||||0.0002|TWO_SIDED|90.0|0.81|0.92|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 42||0.92|0.81|0.0002
71077921|NCT02913105|141664399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.82|||<|0.0001|TWO_SIDED|90.0|0.77|0.88|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 56||0.88|0.77|<.0001
70932656|NCT00811941|141365150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.11||0.217|TWO_SIDED|95.0|-0.36|0.08|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 104 participants in the placebo group and 306 participants in the nalmefene group.|MMRM model with the Baseline CGI-S score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline CGI-S score-by-time and treatment by- time interactions were also included in the model. An unstructured covariance matrix was used.||0.08|-0.36|0.217
70932657|NCT00811941|141365151|SUPERIORITY_OR_OTHER||Ratio to placebo|0.93||||0.273|TWO_SIDED|95.0|0.83|1.05|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 108 participants in the placebo group and 319 participants in the nalmefene group.|Log-transformed GGT values were analysed using an MMRM model with the logtransformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time interaction and treatment-by-time interaction were included in the model. An unstructured covariance matrix was used.||1.05|0.83|0.273
70932658|NCT00811941|141365152|SUPERIORITY_OR_OTHER||Ratio to placebo|0.99||||0.916|TWO_SIDED|95.0|0.9|1.1|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 108 participants in the placebo group and 318 participants in the nalmefene group.|Log-transformed ALAT values were analysed using an MMRM model with the logtransformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time and treatment-by-time interactions were included in the model. An unstructured covariance matrix was used.||1.10|0.90|0.916
70941633|NCT04748445|141383934|OTHER||Slope|0.02906|STANDARD_ERROR_OF_MEAN|1.181||0.0153|TWO_SIDED|90.0|0.009486|0.04863|||Mixed Models Analysis|||EE\_MFCC std 02 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.04863|0.009486|0.0153
71053783|NCT04540406|141611755|OTHER|We employed covariate-adjusted Principal Coordinates Analysis and a subject-stratified PERMANOVA test to assess the overall gut microbiota structural change. These tests are generally neither superiority, non-inferiority, nor equivalence tests. Instead, they are used to detect and evaluate overall differences in the microbial community structure between groups or conditions.||||||||||||||||PCoA (Principal Coordinates Analysis) + PERMANOVA (Permutational Multivariate Analysis of Variance) are exploratory multivariate techniques commonly used in microbiome research to assess and visualize differences in community composition. The null hypothesis for PERMANOVA is that there are no differences in the centroids (multivariate means) of the groups being compared. The microbial communities in different groups or conditions are not significantly different from each other.|To assess the overall structural changes in gut microbiota, we employed covariate-adjusted Principal Coordinates Analysis (PCoA) and a subject-stratified PERMANOVA test. PCoA, an exploratory multivariate technique, helps visualize and interpret patterns in complex microbiome data by reducing dimensionality, with the first principal coordinate (PC1) capturing the largest variation among samples. PERMANOVA, which does not rely on standard parametric assumptions, was used to determine if there are statistically significant differences in the overall composition of microbial communities between groups based on a chosen distance metric. Our analysis aimed to explore whether microbial community compositions differed significantly between Day 0 and Day 28 within the Treatment group, accounting for inter-individual variability. Similarly, we investigated if such differences existed over the same time points in the Control group. The unit of measure was distance metrics.|||
71053784|NCT04091659|141611768|EQUIVALENCE|To determine if the two training approaches were comparable to one another a margin of +/- 1 was used in differences of both OOKS and OOAS scale scores based on previously established literature. An equivalence test of differences using two one-sided tests on data from a cluster-randomized design was conducted using structural equation modeling. Sample sizes of 35 and 57 in group two, obtained by sampling 9 clusters, achieve 85% power to detect equivalence. The significance level is 0.05.|Mean Difference (Final Values)|-0.18||||0.65|TWO_SIDED|95.0|-0.85|0.49|||SEM||||The control group, standard education was the reference for this model.|0.49|-0.85|0.65
71053785|NCT04091659|141611769|EQUIVALENCE|To determine if the two training approaches were comparable to one another a margin of +/- 1 was used in differences of both OOKS and OOAS scale scores based on previously established literature. An equivalence test of differences using two one-sided tests on data from a cluster-randomized design was conducted using structural equation modeling. Sample sizes of 35 and 57 in group two, obtained by sampling 9 clusters, achieve 85% power to detect equivalence. The significance level is 0.05.|Mean Difference (Final Values)|0.26||||0.02|TWO_SIDED|95.0|0.02|0.5|||SEM||The control group, standard education, was the reference|||0.50|0.02|0.02
71053786|NCT01243112|141611772|SUPERIORITY_OR_OTHER|||||||0.359||95.0|||||ANOVA|||Null Hypothesis is that no difference would be measured between treatment arms.||||0.359
71053787|NCT01243112|141611773|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||ANOVA|||||||0.490
71053788|NCT01081834|141611774|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.091|<|0.001|TWO_SIDED|95.0|-1.088|-0.729|||ANCOVA|||||-0.729|-1.088|<0.001
71053789|NCT01081834|141611774|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.16|STANDARD_ERROR_OF_MEAN|0.091|<|0.001|TWO_SIDED|95.0|-1.342|-0.985|||ANCOVA|||||-0.985|-1.342|<0.001
71053790|NCT01081834|141611776|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.34|||<|0.001|TWO_SIDED|95.0|3.1|9.23|||Regression, Logistic|||||9.23|3.10|<0.001
71053791|NCT01081834|141611776|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.61|||<|0.001|TWO_SIDED|95.0|8.14|26.25|||Regression, Logistic|||||26.25|8.14|<0.001
71053792|NCT01081834|141611777|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-35.5|STANDARD_ERROR_OF_MEAN|3.42|<|0.001|TWO_SIDED|95.0|-42.22|-28.78|||ANCOVA|||||-28.78|-42.22|<0.001
71053793|NCT01081834|141611777|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-43.4|STANDARD_ERROR_OF_MEAN|3.402|<|0.001|TWO_SIDED|95.0|-50.06|-36.69|||ANCOVA|||||-36.69|-50.06|<0.001
71053794|NCT01081834|141611778|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-49.1|STANDARD_ERROR_OF_MEAN|5.629|<|0.001|TWO_SIDED|95.0|-59.12|-36.99|||ANCOVA|||||-36.99|-59.12|<0.001
71021095|NCT01244815|141549966|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-3.4||||0.0021||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 3 (Placebo=2.5 mg=5.0 mg\<10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 3. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||0.0021
71021096|NCT01244815|141549966|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-5.28|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 4 (Placebo\<2.5 mg\<5.0 mg\<10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 4. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||<0.0001
71021097|NCT01244815|141549966|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-4.64|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 5 (Placebo=2.5 mg\<5.0 mg\<10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 5. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||<0.0001
71053795|NCT01081834|141611778|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-64.0|STANDARD_ERROR_OF_MEAN|5.616|<|0.001|TWO_SIDED|95.0|-75.02|-52.94|||ANCOVA|||||-52.94|-75.02|<0.001
71106477|NCT01405196|141719786|SUPERIORITY||LS mean difference|-0.71|||||TWO_SIDED|90.0|-3.72|2.3||||||MCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.30|-3.72|
71053796|NCT01081834|141611779|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.9|-1.6|||ANCOVA|||||-1.6|-2.9|<0.001
71053797|NCT01081834|141611779|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-4.0|-2.6|||ANCOVA|||||-2.6|-4.0|<0.001
71053798|NCT01081834|141611780|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.71|STANDARD_ERROR_OF_MEAN|1.093|<|0.001|TWO_SIDED|95.0|-5.86|-1.568|||ANCOVA|||||-1.568|-5.860|<0.001
71053799|NCT01081834|141611780|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-5.42|STANDARD_ERROR_OF_MEAN|1.088|<|0.001|TWO_SIDED|95.0|-7.556|-3.28|||ANCOVA|||||-3.280|-7.556|<0.001
71053800|NCT01081834|141611781|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|4.8||0.267|TWO_SIDED|95.0|-14.8|4.1|||ANCOVA|||||4.1|-14.8|0.267
71053801|NCT01081834|141611781|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-10.2|STANDARD_ERROR_OF_MEAN|4.8||0.034|TWO_SIDED|95.0|-19.6|-0.8|||ANCOVA|||||-0.8|-19.6|0.034
71053802|NCT01081834|141611782|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|1.9|<|0.001|TWO_SIDED|95.0|2.9|10.6|||ANCOVA|||||10.6|2.9|<0.001
71053803|NCT01081834|141611782|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|1.9||0.002|TWO_SIDED|95.0|2.2|9.9|||ANCOVA|||||9.9|2.2|0.002
71053804|NCT03149445|141611794|SUPERIORITY||LS Mean Difference|-5.4||||0.1045|TWO_SIDED|95.0|-12.3|1.5||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||1.5|-12.3|0.1045
71053805|NCT03149445|141611794|SUPERIORITY||LS Mean Difference|0.7||||0.7422|TWO_SIDED|95.0|-4.0|5.3||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||5.3|-4.0|0.7422
71053806|NCT03149445|141611794|SUPERIORITY||LS Mean Difference|5.6||||0.046|TWO_SIDED|95.0|0.1|11.0||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||11.0|0.1|0.0460
71053807|NCT03149445|141611794|SUPERIORITY||LS Mean Difference|4.3||||0.3847|TWO_SIDED|95.0|-9.2|17.8||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||17.8|-9.2|0.3847
71053808|NCT03149445|141611795|SUPERIORITY||LS Mean Difference|-6.2||||0.1326|TWO_SIDED|95.0|-14.9|2.5||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||2.5|-14.9|0.1326
71053809|NCT03149445|141611795|SUPERIORITY||LS Mean Difference|1.2||||0.5148|TWO_SIDED|95.0|-2.9|5.3||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||5.3|-2.9|0.5148
71053810|NCT03149445|141611795|SUPERIORITY||LS Mean Difference|4.5||||0.0605|TWO_SIDED|95.0|-0.3|9.4||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||9.4|-0.3|0.0605
71053811|NCT03149445|141611795|SUPERIORITY||LS Mean Difference|2.6||||0.5198|TWO_SIDED|95.0|-8.8|14.0||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||14.0|-8.8|0.5198
71053812|NCT03149445|141611796|SUPERIORITY||LS Mean Difference|-8.1||||0.0058|TWO_SIDED|95.0|-12.5|-3.6||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||-3.6|-12.5|0.0058
71053813|NCT03149445|141611796|SUPERIORITY||LS Mean Difference|2.1||||0.5142|TWO_SIDED|95.0|-5.3|9.5||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||9.5|-5.3|0.5142
71053814|NCT03149445|141611796|SUPERIORITY||LS Mean Difference|3.1||||0.3794|TWO_SIDED|95.0|-5.1|11.3||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||11.3|-5.1|0.3794
71053815|NCT03149445|141611796|SUPERIORITY||LS Mean Difference|1.0||||0.685|TWO_SIDED|95.0|-6.1|8.1||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||8.1|-6.1|0.6850
71053816|NCT02699060|141611816|SUPERIORITY||Median Difference (Net)|-1.76|STANDARD_DEVIATION|0.8||0.002|TWO_SIDED||||||Mixed Models Analysis|||||||0.002
71106478|NCT01405196|141719786|SUPERIORITY||LS mean difference|2.67|||||TWO_SIDED|90.0|0.14|5.2||||||PCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.20|0.14|
71106479|NCT01405196|141719786|SUPERIORITY||LS mean difference|3.36|||||TWO_SIDED|90.0|0.84|5.89||||||PCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.89|0.84|
70932659|NCT00811941|141365153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.57|STANDARD_ERROR_OF_MEAN|0.65||0.017|TWO_SIDED|95.0|-2.85|-0.29|||Adjusted change from Baseline - Month 13||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 97 participants in the placebo group and 258 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-13); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used.||-0.29|-2.85|0.017
71021098|NCT01244815|141549966|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-5.07|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 6 (Placebo\<2.5 mg=5.0 mg\<10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 6. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||<0.0001
71053817|NCT04916444|141611817|SUPERIORITY|||||||0.691|||||||ANOVA|Two-way repeated measures ANOVA||Null hypothesis is that there was no interaction between the intervention and time factors on the TWSTRS scores.||||0.691
71053818|NCT04916444|141611818|SUPERIORITY|||||||0.816|||||||ANOVA|Two-way repeated measures ANOVA||Null hypothesis is that there was no interaction between the intervention and time factors on the BDI scores.||||0.816
71053819|NCT04916444|141611819|SUPERIORITY|||||||0.167|||||||ANOVA|Two-way repeated measures ANOVA||Null hypothesis is that there was no interaction between the intervention and time factors on the time to complete the TMT-A task.||||0.167
71053820|NCT04916444|141611820|SUPERIORITY|||||||0.507|||||||ANOVA|Two-way repeated measures ANOVA||Null hypothesis is that there was no interaction between the intervention and time factors on the time to complete the TMT-A task.||||0.507
71053821|NCT04916444|141611821|SUPERIORITY|||||||0.056|||||||ANOVA|Two-way repeated measures ANOVA||||||0.056
71053822|NCT04916444|141611822|SUPERIORITY|||||||0.646|||||||ANOVA|Two-way repeated measures ANOVA||||||0.646
71053823|NCT01442688|141611838|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric mean ratio|1.02|||||TWO_SIDED|90.0|0.995|1.04|||ANOVA|||||1.04|0.995|
71053824|NCT01442688|141611839|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric mean ratio|0.991|||||TWO_SIDED|90.0|0.94|1.04|||ANOVA|||||1.04|0.940|
71053825|NCT02737748|141611899|OTHER|||||||0.2217|||||||Cochran-Mantel-Haenszel|||||||0.2217
71053826|NCT02737748|141611900|OTHER|||||||0.0324|||||||Cochran-Mantel-Haenszel|||||||0.0324
71053827|NCT02737748|141611901|OTHER|||||||0.3975|||||||Log Rank|||||||0.3975
71053828|NCT00423319|141611952|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.36|||<|0.0001|TWO_SIDED|95.0|0.22|0.54||Statistically significant at the 1-sided 0.025 level|Farrington-Manning test||Apixaban-enoxaparin|||0.54|0.22|<0.0001
71053829|NCT00423319|141611952|SUPERIORITY_OR_OTHER||Risk Difference|-2.47|||<|0.0001|TWO_SIDED|95.0|-3.54|1.5||Statistically significant at the 1-sided 0.025 level|Farrington-Manning test||Apixaban-enoxaparin|||1.50|-3.54|<0.0001
71053830|NCT00423319|141611953|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.4|||<|0.0001|TWO_SIDED|95.0|0.15|0.8||Statistically significant at the 1-sided 0.025 level|Farrington-Manning test||Apixaban-enoxaparin|||0.80|0.15|<0.0001
71053831|NCT00423319|141611953|SUPERIORITY_OR_OTHER||Risk difference|-0.68||||0.0054|TWO_SIDED|95.0|-1.27|-0.17||Statistically significant at the 1-sided 0.025 level|Chi-squared||Apixaban-enoxaparin|||-0.17|-1.27|0.0054
71053832|NCT00423319|141611955|SUPERIORITY_OR_OTHER||Difference in event rates|0.15||||0.54|TWO_SIDED|95.0|-0.33|0.64||2-sided P-Value|Chi-squared||Major bleeding. Apixaban-enoxaparin|||0.64|-0.33|0.54
71053833|NCT00423319|141611955|SUPERIORITY_OR_OTHER||Difference in event rates|-0.44||||0.43|TWO_SIDED|95.0|-1.53|0.66||2-sided P-Value|Chi-squared||CRNM. Apixaban-enoxaparin|||0.66|-1.53|0.43
71053834|NCT00423319|141611955|SUPERIORITY_OR_OTHER||Difference in event rates|-0.21||||0.72|TWO_SIDED|95.0|-1.38|0.95||2-sided P-Value|Chi-squared||Major or CRNM. Apixaban-enoxaparin|||0.95|-1.38|0.72
71053835|NCT00423319|141611955|SUPERIORITY_OR_OTHER||Difference in event rate|-0.85||||0.34|TWO_SIDED|95.0|-2.61|0.9||2-sided P-Value|Chi-squared||Any bleeding. Apixaban-enoxaparin|||0.90|-2.61|0.34
71053836|NCT00423319|141611965|SUPERIORITY_OR_OTHER||Difference in event rates|-0.04|||||TWO_SIDED|95.0|-0.34|0.26|||||Apixaban-enoxaparin. MI/stroke|||0.26|-0.34|
71053837|NCT00423319|141611965|SUPERIORITY_OR_OTHER||Difference in event rates|0.07|||||TWO_SIDED|95.0|-0.17|0.34|||||Apixaban-enoxaparin. MI|||0.34|-0.17|
71053838|NCT00423319|141611965|SUPERIORITY_OR_OTHER||Difference in event rates|-0.11|||||TWO_SIDED|95.0|-0.35|0.07|||||Apixaban-enoxaparin. Stroke|||0.07|-0.35|
71053839|NCT00423319|141611965|SUPERIORITY_OR_OTHER||Difference in event rates|-0.04|||||TWO_SIDED|95.0|-0.26|0.17|||||Apixaban-enoxaparin. Thrombocytopenia|||0.17|-0.26|
71053840|NCT01584843|141611966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.83||||0.091|TWO_SIDED|95.0|-21.81|2.14||LSD=Least Significant Difference|Fisher LSD method|||||2.14|-21.81|0.091
71053841|NCT01584843|141611966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.08||||0.338|TWO_SIDED|95.0|-20.39|8.23|||Fisher LSD method|||||8.23|-20.39|0.338
71053842|NCT01584843|141611966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75||||0.524|TWO_SIDED|95.0|-9.83|17.33|||Fisher LSD method|||||17.33|-9.83|0.524
70941634|NCT04748445|141383934|OTHER||Slope|3.96|STANDARD_ERROR_OF_MEAN|1.447||0.0071|TWO_SIDED|90.0|1.563|6.357|||Mixed Models Analysis|||EE\_MFCC std 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||6.357|1.563|0.0071
71021099|NCT01244815|141549966|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-5.49|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 7 (Placebo\<2.5 mg\<5.0 mg=10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 7. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||<0.0001
71021100|NCT01244815|141549967|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.6|||<|0.001|TWO_SIDED|95.0|-0.9|-0.3||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.3|-0.9|<0.001
71021101|NCT01244815|141549967|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.7|||<|0.001|TWO_SIDED|95.0|-0.9|-0.4||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.4|-0.9|<0.001
71021102|NCT01244815|141549967|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.7|||<|0.001|TWO_SIDED|95.0|-1.0|-0.4||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.4|-1.0|<0.001
71021103|NCT01244815|141549968|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.0||||0.018|TWO_SIDED|95.0|1.2|7.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 4 (LOCF)||7.6|1.2|0.018
71021104|NCT01244815|141549968|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.4||||0.008|TWO_SIDED|95.0|1.4|8.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 4 (LOCF)||8.6|1.4|0.008
71021105|NCT01244815|141549968|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.1||||0.129|TWO_SIDED|95.0|0.8|5.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 4 (LOCF)||5.6|0.8|0.129
71021106|NCT01244815|141549968|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.9||||0.003|TWO_SIDED|95.0|1.4|5.9||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 7 (LOCF)||5.9|1.4|0.003
71053843|NCT01584843|141611966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.85||||0.031|TWO_SIDED|95.0|-24.46|-1.24|||Fisher LSD method|||||-1.24|-24.46|0.031
71021107|NCT01244815|141549968|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.8||||0.005|TWO_SIDED|95.0|1.4|5.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 7 (LOCF)||5.6|1.4|0.005
71021108|NCT01244815|141549968|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.6|||<|0.001|TWO_SIDED|95.0|1.8|7.3||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 7 (LOCF)||7.3|1.8|<0.001
71053844|NCT01584843|141611966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.72||||0.005|TWO_SIDED|95.0|-28.06|-5.38|||Fisher LSD method|||||-5.38|-28.06|0.005
71053845|NCT01584843|141611966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.87||||0.49|TWO_SIDED|95.0|-15.21|7.47|||Fisher LSD method|||||7.47|-15.21|0.490
71053846|NCT00311402|141611983|NON_INFERIORITY_OR_EQUIVALENCE|The non-event rates after 1 year in the Aggrenox group and ASA group are estimated at 94.0% and 91.5%, respectively. The non-inferiority margin was set to 2%. Under these conditions, 500 patients per group were supposed to be enough to detect the non-inferiority of Aggrenox with over 80% power.|Cox Proportional Hazard|1.47||||0.097||95.0|0.93|2.31|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||2.31|0.93|0.097
71053847|NCT00311402|141611984|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.79||||0.223||95.0|0.7|4.54|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||4.54|0.70|0.223
71053848|NCT00311402|141611985|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.0||||0.998|ONE_SIDED|95.0|0.0||||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.|||0|0.998
70932660|NCT00811941|141365154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.47|STANDARD_ERROR_OF_MEAN|3.07||0.036|TWO_SIDED|95.0|-12.53|-0.42|||Adjusted change from Baseline - Month 13||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 97 participants in the placebo group and 258 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-13); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used.||-0.42|-12.53|0.036
70932661|NCT00811941|141365155|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.976|TWO_SIDED|95.0|0.67|1.52|||Adjusted Odds Ratio (OR) response|||The analysis of RSDRL used a logistic regression (LREG) model, with country, sex, Baseline DRL, and treatment as fixed effects, and missing values were imputed using individual-patient predicted values of TAC derived from the MMRM model.||1.52|0.67|0.976
70932662|NCT00811941|141365156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.056|TWO_SIDED|95.0|-0.44|0.01|||Adjusted change from Baseline to Week 52||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 95 participants in the placebo group and 258 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model; an unstructured covariance matrix was used.||0.01|-0.44|0.056
71021109|NCT01244815|141549968|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.2||||0.018|TWO_SIDED|95.0|1.1|4.1||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 14 (LOCF)||4.1|1.1|0.018
71021110|NCT01244815|141549968|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.1|||<|0.001|TWO_SIDED|95.0|2.2|7.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 14 (LOCF)||7.6|2.2|<0.001
71021111|NCT01244815|141549968|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.1|||<|0.001|TWO_SIDED|95.0|2.2|7.6|||Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 14 (LOCF)||7.6|2.2|<0.001
71053849|NCT00311402|141611986|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.02||||0.977||95.0|0.21|5.07|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||5.07|0.21|0.977
71053850|NCT00311402|141611987|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.58||||0.192||95.0|0.26|1.31|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||1.31|0.26|0.192
70932663|NCT00811941|141365157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.12||0.029||95.0|-0.5|-0.03|||Adjusted change from Baseline to Week 52||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 95 participants in the placebo group and 258 participants in the nalmefene group.|MMRM model with the Baseline CGI-S score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline CGI-S score-by-time and treatment by- time interactions were also included in the model. An unstructured covariance matrix was used.||-0.03|-0.50|0.029
70932664|NCT00811941|141365158|SUPERIORITY_OR_OTHER||Ratio to placebo|0.78||||0.001|TWO_SIDED|95.0|0.67|0.9|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 98 participants in the placebo group and 259 participants in the nalmefene group.|Log-transformed GGT values were analysed using an MMRM model with the logtransformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time interaction and treatment-by-time interaction were included in the model. An unstructured covariance matrix was used.||0.90|0.67|0.001
70932665|NCT00811941|141365159|SUPERIORITY_OR_OTHER||Ratio to placebo|0.88||||0.037|TWO_SIDED|95.0|0.79|0.99|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 97 participants in the placebo group and 259 participants in the nalmefene group.|Log-transformed GGT values were analysed using an MMRM model with the logtransformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time interaction and treatment-by-time interaction were included in the model. An unstructured covariance matrix was used.||0.99|0.79|0.037
70932666|NCT00622700|141365174|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.574||||0.0087|TWO_SIDED|95.0|0.379|0.869||P value was derived using Wald chi-squared test in the Cox proportional hazard model.|Wald chi-squared|||A step-down hierarchical testing procedure, starting with the test of teriflunomide 14 mg versus placebo was used. Time to conversion to CDMS was analyzed using the Cox proportional hazard model with treatment, region, and baseline monofocal/multifocal status as covariates.||0.869|0.379|0.0087
70932667|NCT00622700|141365174|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.628||||0.0271|TWO_SIDED|95.0|0.416|0.949||P value was derived using Wald chi-squared test in the Cox proportional hazard model.|Wald chi-squared|||A step-down hierarchical testing procedure was used. The second step was the test of teriflunomide 7 mg versus placebo for time to conversion to CDMS. Time to conversion to CDMS was analyzed using the Cox proportional hazard model with treatment, region, and baseline monofocal/multifocal status as covariates.||0.949|0.416|0.0271
70932668|NCT00622700|141365175|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.651||||0.0003|TWO_SIDED|95.0|0.515|0.822||P value was derived using Wald chi-squared test in the Cox proportional hazard model.|Wald chi-squared|||A step-down hierarchical testing procedure was used. The third step was the test of teriflunomide 14 mg versus placebo for time to conversion to DMS. This was analyzed using the Cox proportional hazard model with treatment, region, and baseline monofocal/multifocal status as covariates.||0.822|0.515|0.0003
71053851|NCT00311402|141611988|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.88||||0.215||95.0|0.69|5.07|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||5.07|0.69|0.215
70851337|NCT00669409|141190546|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-33.2|-0.3||||||Change at Week 1, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-0.3|-33.2|
70932669|NCT00622700|141365175|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.686||||0.002|TWO_SIDED|95.0|0.54|0.871||P value was derived using Wald chi-squared test in the Cox proportional hazard model.|Wald chi-squared|||A step-down hierarchical testing procedure was used. The fourth step was the test of teriflunomide 7 mg versus placebo for time to conversion to DMS. This was analyzed using the Cox proportional hazard model with treatment, region, and baseline monofocal/multifocal status as covariates.||0.871|0.540|0.0020
70932670|NCT03611556|141365195|SUPERIORITY||Rate difference|-8.0||||0.3614|TWO_SIDED|95.0|-27.6|12.1||Nominal P-value for comparison of treatment groups obtained from Cochran-Mantel-Haenszel-test was stratified by cluster of differentiation 73 (CD73) level.|Cochran-Mantel-Haenszel||||80% Confidence Interval 2-Sided: -20.9 to 5.2|12.1|-27.6|0.3614
71053852|NCT00311402|141611989|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.16||||0.443||95.0|0.79|1.69|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||1.69|0.79|0.443
71053853|NCT00311402|141611990|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.52||||0.043||95.0|1.01|2.29|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||2.29|1.01|0.043
71053854|NCT00311402|141611991|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.04||||0.919||95.0|0.48|2.25|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||2.25|0.48|0.919
71053855|NCT00311402|141611992|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.34||||0.101||95.0|0.94|1.91|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||1.91|0.94|0.101
71053856|NCT02640053|141611993|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.26
71053857|NCT02640053|141611994|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
71053858|NCT02640053|141611995|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
71053859|NCT02640053|141611996|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
71053860|NCT02640053|141611997|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
71053861|NCT02640053|141611998|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
71053862|NCT02640053|141611999|SUPERIORITY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||||||0.62
71053863|NCT02640053|141612000|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||||||0.67
71053864|NCT02036775|141612008|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the area under the curve (AUCss 0-24) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|110.68|STANDARD_DEVIATION|20.42|||TWO_SIDED|90.0|99.84|122.69|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||122.69|99.84|
71053865|NCT02036775|141612008|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the area under the curve (AUCss 0-24) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|103.39|STANDARD_DEVIATION|13.52|||TWO_SIDED|90.0|96.54|110.74|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||110.74|96.54|
71053866|NCT02036775|141612008|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the area under the curve (AUCss 0-24) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|106.93|STANDARD_DEVIATION|12.65|||TWO_SIDED|90.0|100.29|114.02|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||114.02|100.29|
71053867|NCT02036775|141612009|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the peak concentration (Cmax ss) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|84.72|STANDARD_DEVIATION|19.01|||TWO_SIDED|90.0|76.96|93.25|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||93.25|76.96|
71053868|NCT02036775|141612009|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the peak concentration (Cmax ss) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|103.87|STANDARD_DEVIATION|17.19|||TWO_SIDED|90.0|95.22|113.31|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||113.31|95.22|
71053869|NCT02036775|141612009|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the peak concentration (Cmax ss) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|80.94|STANDARD_DEVIATION|17.95|||TWO_SIDED|90.0|73.92|88.62|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||88.62|73.92|
70851338|NCT00669409|141190546|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-27.2|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-43.7|-10.8||||||Change at Week 1, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-10.8|-43.7|
71021112|NCT01244815|141549968|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.042|TWO_SIDED|95.0|1.0|3.4||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 21 (LOCF)||3.4|1.0|0.042
71021113|NCT01244815|141549968|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.2|||<|0.001|TWO_SIDED|95.0|1.7|5.8||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 21 (LOCF)||5.8|1.7|<0.001
71021114|NCT01244815|141549968|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.9|||<|0.001||95.0|1.6|5.3||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 21 (LOCF)||5.3|1.6|<0.001
71021115|NCT01244815|141549969|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25||||0.014|TWO_SIDED|95.0|-0.45|-0.05|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.05|-0.45|0.014
71021116|NCT01244815|141549969|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.17||||0.107|TWO_SIDED|95.0|-0.37|0.04|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.04|-0.37|0.107
71021117|NCT01244815|141549969|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.21||||0.039|TWO_SIDED|95.0|-0.42|-0.01|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.01|-0.42|0.039
71021118|NCT01244815|141549970|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.33||||0.006|TWO_SIDED|95.0|-0.56|-0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.10|-0.56|0.006
71021119|NCT01244815|141549970|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.35||||0.003|TWO_SIDED|95.0|-0.59|-0.12|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.12|-0.59|0.003
71021120|NCT01244815|141549970|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.44|||<|0.001|TWO_SIDED|95.0|-0.67|-0.21|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.21|-0.67|<0.001
71021121|NCT01244815|141549971|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.34||||0.011|TWO_SIDED|95.0|-0.61|-0.08|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.08|-0.61|0.011
71021122|NCT01244815|141549971|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.63|||<|0.001|TWO_SIDED|95.0|-0.89|-0.36|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.36|-0.89|<0.001
71079511|NCT00482170|141666457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.32||0.974|TWO_SIDED|95.0|-0.62|0.64||Statistical testing, 2-sided, was done at 5% significance level.|ANOVA|||Last observation: ANOVA method was used for the analysis.||0.64|-0.62|0.974
70851339|NCT00669409|141190546|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-23.4|9.9||||||Change at Week 1, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.9|-23.4|
70851340|NCT00669409|141190546|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.4|STANDARD_ERROR_OF_MEAN|8.22|||TWO_SIDED|95.0|-35.6|-3.2||||||Change at Week 1, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.2|-35.6|
71021123|NCT01244815|141549971|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.61|||<|0.001|TWO_SIDED|95.0|-0.88|-0.35|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.35|-0.88|<0.001
71021124|NCT01244815|141549972|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.61|||<|0.001|TWO_SIDED|95.0|-0.9|-0.32|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.32|-0.90|<0.001
70851341|NCT00669409|141190546|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-24.4|STANDARD_ERROR_OF_MEAN|10.86|||TWO_SIDED|95.0|-45.8|-2.9||||||Change at Week 1, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.9|-45.8|
70851342|NCT00669409|141190547|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-18.5|12.6||||||Change at Week 2, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.6|-18.5|
71021125|NCT01244815|141549972|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.75|||<|0.001|TWO_SIDED|95.0|-1.04|-0.46|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.46|-1.04|<0.001
71021126|NCT01244815|141549972|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.74|||<|0.001|TWO_SIDED|95.0|-1.03|-0.45|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.45|-1.03|<0.001
71021127|NCT01244815|141549973|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.07||||0.536|TWO_SIDED|95.0|-0.28|0.15|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.15|-0.28|0.536
71021128|NCT01244815|141549973|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.811|TWO_SIDED|95.0|-0.24|0.19|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.19|-0.24|0.811
71021129|NCT01244815|141549973|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.07||||0.556|TWO_SIDED|95.0|-0.15|0.28|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.28|-0.15|0.556
71021130|NCT01244815|141549974|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.21||||0.053|TWO_SIDED|95.0|-0.42|0.0|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.00|-0.42|0.053
71021131|NCT01244815|141549974|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.18||||0.094|TWO_SIDED|95.0|-0.4|0.03|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.03|-0.40|0.094
71021132|NCT01244815|141549974|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.15||||0.178|TWO_SIDED|95.0|-0.36|0.07|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.07|-0.36|0.178
71021133|NCT01244815|141549975|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.08||||0.506|TWO_SIDED|95.0|-0.33|0.16|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.16|-0.33|0.506
71021134|NCT01244815|141549975|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.19||||0.131|TWO_SIDED|95.0|-0.43|0.06|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.06|-0.43|0.131
71021135|NCT01244815|141549975|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.16||||0.211|TWO_SIDED|95.0|-0.4|0.09|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.09|-0.40|0.211
71053870|NCT02036775|141612010|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the dose-adjusted total exposure (AUCss 0-24 norm) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|88.54|STANDARD_DEVIATION|20.42|||TWO_SIDED|90.0|79.87|98.15|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||98.15|79.87|
71079512|NCT00482170|141666458|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated using ANOVA.||||0.030
71079513|NCT00482170|141666458|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated using ANOVA.||||0.010
70851343|NCT00669409|141190547|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.7|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-30.3|0.8||||||Change at Week 2, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.8|-30.3|
70851344|NCT00669409|141190547|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|12.4|STANDARD_ERROR_OF_MEAN|7.92|||TWO_SIDED|95.0|-3.2|28.1||||||Change at Week 2, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||28.1|-3.2|
71053871|NCT02036775|141612010|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the dose-adjusted total exposure (AUCss 0-24 norm) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|103.39|STANDARD_DEVIATION|13.52|||TWO_SIDED|90.0|96.54|110.74|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||110.74|96.54|
71053872|NCT02036775|141612010|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the dose-adjusted total exposure (AUCss 0-24 norm) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|85.55|STANDARD_DEVIATION|12.65|||TWO_SIDED|90.0|80.23|91.22|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||91.22|80.23|
71053873|NCT02036775|141612011|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the rate of absorption at steady state (Cmax ss/AUCss 0-24) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|76.55|STANDARD_DEVIATION|14.55|||TWO_SIDED|90.0|71.1|82.4|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||82.40|71.10|
71053874|NCT02036775|141612011|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the rate of absorption at steady state (Cmax ss/AUCss 0-24) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|100.46|STANDARD_DEVIATION|11.65|||TWO_SIDED|90.0|94.69|106.58|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||106.58|94.69|
71053875|NCT02036775|141612011|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the rate of absorption at steady state (Cmax ss/AUCss 0-24) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|75.69|STANDARD_DEVIATION|15.64|||TWO_SIDED|90.0|69.92|81.93|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||81.93|69.92|
71053876|NCT00678886|141612019|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.813|TWO_SIDED|95.0|-0.06|0.08|||Mixed effects repeated measures model|||Mixed meal-stimulated C-peptide AUC, Placebo Vs Otelixizumab at Month 12||0.08|-0.06|0.813
70932671|NCT03611556|141365195|SUPERIORITY||Rate difference|3.8||||0.6503|TWO_SIDED|95.0|-13.2|20.7||Nominal P-value for comparison of treatment groups obtained from Cochran-Mantel-Haenszel-test was stratified by CD73 level.|Cochran-Mantel-Haenszel||||80% Confidence Interval 2-Sided: -7.4 to 15.0|20.7|-13.2|0.6503
71053877|NCT00678886|141612020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.737|TWO_SIDED|95.0|0.47|1.7|||Hochberg adjusted|||Percentage of responders, Placebo Vs Otelixizumab at Week 12||1.70|0.47|0.737
71053878|NCT00678886|141612020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.737|TWO_SIDED|95.0|0.42|1.39|||Hochberg adjusted|||Percentage of responders, Placebo Vs Otelixizumab at Month 6||1.39|0.42|0.737
71053879|NCT00678886|141612020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.481|TWO_SIDED|95.0|0.45|1.46|||Hochberg adjusted|||Percentage of responders, Placebo Vs Otelixizumab at Month 12||1.46|0.45|0.481
71053880|NCT00678886|141612021|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.281|TWO_SIDED|95.0|-0.07|0.01|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||Mean insulin use, Placebo Vs Otelixizumab at Week 12||0.01|-0.07|0.281
71053881|NCT00678886|141612021|SUPERIORITY||Mean Difference (Net)|0.0||||0.969|TWO_SIDED|95.0|-0.05|0.05|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||Mean insulin use, Placebo Vs Otelixizumab at Month 6||0.05|-0.05|0.969
71053882|NCT00678886|141612021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.272|TWO_SIDED|95.0|-0.08|0.02|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||Mean insulin use, Placebo Vs Otelixizumab at Month 12||0.02|-0.08|0.272
71053883|NCT00678886|141612022|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.18||||0.289|TWO_SIDED|95.0|-0.16|0.52|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||HbA1c levels, Placebo Vs Otelixizumab at Month 12||0.52|-0.16|0.289
71053884|NCT00678886|141612022|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.538|TWO_SIDED|95.0|-0.15|0.49|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||HbA1c levels, Placebo Vs Otelixizumab at Month 6||0.49|-0.15|0.538
71053885|NCT00678886|141612022|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.538|TWO_SIDED|95.0|-0.19|0.36|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||HbA1c levels, Placebo Vs Otelixizumab at Week 12||0.36|-0.19|0.538
71053886|NCT00678886|141612031|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.12||||0.54|TWO_SIDED|95.0|-0.88|3.11|||Mixed effects repeated measures model|||ADRR, Placebo Vs Otelixizumab at Week 12||3.11|-0.88|0.540
71053887|NCT00678886|141612031|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.83||||0.546|TWO_SIDED|95.0|-1.89|3.56|||Mixed effects repeated measures model|||ADRR, Placebo Vs Otelixizumab at Month 6||3.56|-1.89|0.546
71053888|NCT00678886|141612031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93||||0.462|TWO_SIDED|95.0|-1.56|3.42|||Mixed effects repeated measures model|||ADRR, Placebo Vs Otelixizumab at Month 12||3.42|-1.56|0.462
71053889|NCT00678886|141612032|SUPERIORITY_OR_OTHER|||||||0.957|||||||Hochberg-adjusted|||Composite Rank Summary for HbA1c and Exogenous Insulin Use, Placebo Vs Otelixizumab at Month 6||||0.957
71053890|NCT00678886|141612032|SUPERIORITY_OR_OTHER|||||||0.957|||||||Hochberg-adjusted|||Composite Rank Summary for HbA1c and Exogenous Insulin Use, Placebo Vs Otelixizumab at Month 12||||0.957
71053891|NCT00678886|141612033|SUPERIORITY_OR_OTHER|||||||0.653|||||||Hochberg-adjusted|||Composite Rank Summary for C-Peptide AUC, HbA1c and Exogenous Insulin Use, Placebo Vs Otelixizumab at Month 6||||0.653
70932672|NCT03611556|141365202|SUPERIORITY||Hazard Ratio (HR)|1.26|||||TWO_SIDED|95.0|0.79|1.983|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model stratified by CD73 level with ties handled by the Efron method.|||1.983|0.790|
71053892|NCT00678886|141612033|SUPERIORITY_OR_OTHER|||||||0.653|||||||Hochberg-adjusted|||Composite Rank Summary for C-Peptide AUC, HbA1c and Exogenous Insulin Use, Placebo Vs Otelixizumab at Month 12||||0.653
71053893|NCT00206323|141612039|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0259|||||||t-test, 2 sided|||"Primary variable change of TTS/YGTSS at the BSL to Day 70. Changes of YGTSS compared using analysis of covariance with score at day 1 as a covariate. Groups compared for incidence of AE's and of AESI based on Fisher's Exact Test. All tests were two-sided at the 5% level of significance.~The Total Tic Score is a summation of the Total Motor Tic and Total Phonic Tic Scores. The Overall Impairment Rating is rated on a 50-point scale anchored by 0 (No impairment) and 50 (Severe impairment)"||||0.0259
71053894|NCT01943994|141612048|SUPERIORITY||Odds Ratio (OR)|6.12||||0.003|TWO_SIDED|95.0|1.99|23.26|||Regression, Logistic|||||23.26|1.99|0.003
71053895|NCT02288182|141612102|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Student's t-test comparing the group means was planned and performed (successfully). However, due to some outliers, the central tendencies have been reported as medians (instead of arithmetic means). Therefore an additional non-parameteric test (Mann-Whitney U-test) was performed.||||0.001
71053896|NCT00620659|141612122|SUPERIORITY_OR_OTHER|||||||0.615||95.0|||||Mixed Models Analysis|The mixed model included terms for period and treatment.||||||0.615
71053897|NCT00620659|141612123|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 1.5 minutes. If the lower bound of the one-sided 95% confidence interval for MK0249 minus modafinil 200 mg was greater than -1.5 minutes, non-inferiority would be established.|Difference in Least Squares Mean|-4.11|||||TWO_SIDED|90.0|-5.92|-2.3||||||||-2.30|-5.92|
71053898|NCT00620659|141612124|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 1.5 minutes. If the lower bound of the one-sided 95% confidence interval for MK0249 minus modafinil 200 mg was greater than -1.5 minutes, non-inferiority would be established.|Difference in Least Squares Mean|-3.8|||||TWO_SIDED|90.0|-5.23|-2.38||||||||-2.38|-5.23|
71053899|NCT00620659|141612125|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||Mixed Models Analysis|The mixed model included terms for period and treatment.||||||0.079
71053900|NCT00620659|141612126|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Mixed Models Analysis|The mixed model included terms for period and treatment.||||||0.003
71053901|NCT02056392|141612137|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-0.2|||||TWO_SIDED|90.0|-1.8|1.5|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||1.5|-1.8|
71053902|NCT02056392|141612137|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|6.1|||||TWO_SIDED|90.0|4.4|7.7|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||7.7|4.4|
71053903|NCT02056392|141612138|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|90.0|-2.0|1.3|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||1.3|-2.0|
71053904|NCT02056392|141612138|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|9.2|||||TWO_SIDED|90.0|7.6|10.8|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||10.8|7.6|
71053905|NCT02056392|141612139|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|0.9|||||TWO_SIDED|90.0|-0.7|2.5|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||2.5|-0.7|
71053906|NCT02056392|141612139|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|9.9|||||TWO_SIDED|90.0|8.3|11.5|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||11.5|8.3|
70932673|NCT03611556|141365202|SUPERIORITY||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.498|1.131|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model stratified by CD73 level with ties handled by the Efron method.|||1.131|0.498|
71021136|NCT01244815|141549976|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.23||||0.079|TWO_SIDED|95.0|-0.49|0.03|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.03|-0.49|0.079
71106480|NCT01405196|141719786|SUPERIORITY||LS mean difference|3.23|||||TWO_SIDED|90.0|0.7|5.76||||||PCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.76|0.70|
71021137|NCT01244815|141549976|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.34||||0.01|TWO_SIDED|95.0|-0.6|-0.08|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.08|-0.60|0.010
71021138|NCT01244815|141549976|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.2||||0.139|TWO_SIDED|95.0|-0.46|0.06|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.06|-0.46|0.139
71021139|NCT01244815|141549977|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.61||||0.004|TWO_SIDED|95.0|-4.38|-0.83|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.83|-4.38|0.004
71021140|NCT01244815|141549977|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.17||||0.017|TWO_SIDED|95.0|-3.95|-0.39|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.39|-3.95|0.017
71021141|NCT01244815|141549977|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.16||||0.017|TWO_SIDED|95.0|-3.93|-0.38|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.38|-3.93|0.017
71021142|NCT01244815|141549978|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.79||||0.395|TWO_SIDED|95.0|-2.62|1.04|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||1.04|-2.62|0.395
71021143|NCT01244815|141549978|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.44||||0.009|TWO_SIDED|95.0|-4.26|-0.63|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.63|-4.26|0.009
71021144|NCT01244815|141549978|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.44||||0.121|TWO_SIDED|95.0|-3.27|0.38|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.38|-3.27|0.121
71021145|NCT01244815|141549979|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.44||||0.135|TWO_SIDED|95.0|-3.33|0.45|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.45|-3.33|0.135
71021146|NCT01244815|141549979|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.19||||0.023|TWO_SIDED|95.0|-4.08|-0.3|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.30|-4.08|0.023
71021147|NCT01244815|141549979|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.28||||0.189|TWO_SIDED|95.0|-3.2|0.63|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.63|-3.20|0.189
71021148|NCT01244815|141549980|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|4.29||||0.002|TWO_SIDED|95.0|1.56|7.02|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||7.02|1.56|0.002
71021149|NCT01244815|141549980|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|6.95|||<|0.001|TWO_SIDED|95.0|4.22|9.68|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||9.68|4.22|<0.001
71106481|NCT01405196|141719786|SUPERIORITY||LS mean difference|3.77|||||TWO_SIDED|90.0|1.24|6.3||||||PCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||6.30|1.24|
71106482|NCT01405196|141719786|SUPERIORITY||LS mean difference|3.1|||||TWO_SIDED|90.0|0.57|5.63||||||PCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.63|0.57|
71053907|NCT02056392|141612140|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|0.4|||||TWO_SIDED|90.0|-1.2|2.0|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||2.0|-1.2|
71053908|NCT02056392|141612140|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|10.1|||||TWO_SIDED|90.0|8.5|11.8|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||11.8|8.5|
71053909|NCT02056392|141612141|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-0.2|||||TWO_SIDED|90.0|-1.8|1.5|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||1.5|-1.8|
71053910|NCT02056392|141612141|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|11.9||||||90.0|10.3|13.6|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||13.6|10.3|
71053911|NCT02056392|141612142|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-1.5|||||TWO_SIDED|90.0|-3.1|0.2|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||0.2|-3.1|
71053912|NCT02056392|141612142|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|10.8|||||TWO_SIDED|90.0|9.2|12.5|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||12.5|9.2|
71053913|NCT02056392|141612143|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-1.8|||||TWO_SIDED|90.0|-3.4|-0.1|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||-0.1|-3.4|
71053914|NCT02056392|141612143|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|8.8|||||TWO_SIDED|90.0|7.1|10.4|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||10.4|7.1|
71053915|NCT02056392|141612144|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-1.3|||||TWO_SIDED|90.0|-2.9|0.4|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||0.4|-2.9|
71053916|NCT02056392|141612144|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|8.9|||||TWO_SIDED|90.0|7.2|10.5|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||10.5|7.2|
71053917|NCT02056392|141612145|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-4.7|||||TWO_SIDED|90.0|-6.4|-3.1|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||-3.1|-6.4|
71053918|NCT02056392|141612145|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|7.6|||||TWO_SIDED|90.0|6.0|9.3|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||9.3|6.0|
71053919|NCT02056392|141612146|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-2.5|||||TWO_SIDED|90.0|-4.1|-0.9|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||-0.9|-4.1|
71079514|NCT00482170|141666459|SUPERIORITY_OR_OTHER|||||||0.984||95.0|||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.984
71021150|NCT01244815|141549980|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|5.11|||<|0.001|TWO_SIDED|95.0|2.31|7.91|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||7.91|2.31|<0.001
71021151|NCT01244815|141549981|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|2.24||||0.05|TWO_SIDED|95.0|0.0|4.48|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||4.48|-0.00|0.050
71021152|NCT01244815|141549981|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|1.35||||0.239|TWO_SIDED|95.0|-0.9|3.59|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||3.59|-0.90|0.239
71021153|NCT01244815|141549981|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|2.78||||0.018|TWO_SIDED|95.0|0.48|5.08|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||5.08|0.48|0.018
71053920|NCT02056392|141612146|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|4.0|||||TWO_SIDED|90.0|2.4|5.7|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||5.7|2.4|
71053921|NCT03867097|141612180|SUPERIORITY||LS mean difference in change|-0.77|STANDARD_ERROR_OF_MEAN|4.047||0.8498|TWO_SIDED|95.0|-9.04|7.49|||ANCOVA||The Shapiro-Wilk normality test of residuals indicated that the data did not have a normal distribution (p-value 0.0108).|"Treatment comparison of change versus placebo. LS mean difference in change. When a subject had no RP attacks in the past 24 hours, the frequency was considered as zero for that day.~The LS means, SEs, CIs, and p-values came from an ANCOVA model with randomized treatment group and use of phosphodiesterase inhibitors at screening (yes, no) as factors and baseline as a covariate."||7.49|-9.04|0.8498
71053922|NCT03867097|141612180|SUPERIORITY||Median Difference (Final Values)|-0.24||||0.9729|TWO_SIDED|95.0|-9.97|9.32|||Wilcoxon (Mann-Whitney)|||"Change in the Weekly Frequency of Symptomatic Raynaud's Phenomenon Attacks From Baseline to the Double-Blind Endpoint Using Nonparametric Analysis - Modified Intent-to-Treat Population.~Treatment comparison of change versus placebo."||9.32|-9.97|0.9729
71053923|NCT01372774|141612181|SUPERIORITY||Hazard Ratio (HR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.35|0.63|||Log Rank|||||0.63|0.35|<0.0001
71053924|NCT01372774|141612182|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.7|TWO_SIDED|95.0|0.76|1.5|||Log Rank|||||1.50|0.76|0.70
71053925|NCT01372774|141612183|SUPERIORITY|||||||0.00068||||||Intracranial Brain Control Rates estimated via 1-Cumulative Incidence Rate from Competing Risk survival analysis of time to the specific recurrence type. Deaths without recurrence are censored at time of death.|Gray's K-sample|||||||0.00068
71053926|NCT01372774|141612185|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||0.31
71053927|NCT00324649|141612203|SUPERIORITY_OR_OTHER|||||||0.0014||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.0014
71021154|NCT01244815|141549982|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.39||||0.001|TWO_SIDED|95.0|0.15|0.62|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||0.62|0.15|0.001
71021155|NCT01244815|141549982|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.18||||0.135|TWO_SIDED|95.0|-0.06|0.41|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||0.41|-0.06|0.135
71021156|NCT01244815|141549982|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.25||||0.044|TWO_SIDED|95.0|0.01|0.49|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||0.49|0.01|0.044
71021157|NCT03547531|141550016|OTHER||||||>|0.05|||||||t-test, 2 sided|independent t-test||Null hypothesis: the mean of plaque index between groups are not different|the statistical analysis used in this study is independent t-test|||>0.05
71021158|NCT03547531|141550017|OTHER|this data is analyzed using independent t-test|||||>|0.05|||||||t-test, 2 sided|||null hypotesis: there is no difference of mean of gingival index between groups|this data is analyzed using independent t-test|||>0.05
71021159|NCT03547531|141550018|OTHER|this data is analyzed using independent t-test|||||<|0.05|||||||t-test, 2 sided|||null hypotesis: there is no difference of mean of plaque index between groups|this data is analyzed using independent t-test|||<0.05
71021160|NCT03547531|141550019|OTHER|this data is analyzed using independent t-test|||||<|0.05|||||||t-test, 2 sided|||null hypotesis: there is no difference of mean of gingival index between groups|this data is analyzed using independent t-test|||<0.05
71021161|NCT02117479|141550026|OTHER||Hazard Ratio (HR)|0.969|||||TWO_SIDED|95.0|0.747|1.256||||||||1.256|0.747|
71021162|NCT02117479|141550027|OTHER||Hazard Ratio (HR)|1.056|||||TWO_SIDED|95.0|0.827|1.348||||||||1.348|0.827|
71021163|NCT02444182|141550032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|STANDARD_DEVIATION|0.21||0.015|TWO_SIDED||||||paired t-test|||Null hypothesis was no difference in Gingival index between probiotics and control groups||||0.015
71021164|NCT02444182|141550033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_DEVIATION|0.09||0.909|TWO_SIDED||||||paired t-test|||Null hypothesis was no difference in plaque index between probiotics and control groups||||0.909
71021165|NCT01507831|141550060|SUPERIORITY_OR_OTHER||LS Mean Difference|-61.9|||<|0.0001|TWO_SIDED|95.0|-64.3|-59.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-59.4|-64.3|<0.0001
71021166|NCT01507831|141550061|SUPERIORITY_OR_OTHER||LS Mean Difference|-63.5|||<|0.0001|TWO_SIDED|95.0|-65.9|-61.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|A hierarchial testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchial testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-61.2|-65.9|<0.0001
71106483|NCT01405196|141719786|SUPERIORITY||LS mean difference|3.03||||||90.0|0.5|5.56||||||PCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.56|0.50|
71106484|NCT01405196|141719786|SUPERIORITY||LS mean difference|1.96|||||TWO_SIDED|90.0|-0.53|4.46||||||PCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.46|-0.53|
71106485|NCT01405196|141719786|SUPERIORITY||LS mean difference|2.68||||||90.0|0.2|5.17||||||PCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.17|0.20|
71106486|NCT01405196|141719786|SUPERIORITY||LS mean difference|1.84|||||TWO_SIDED|90.0|-0.65|4.32||||||PCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.32|-0.65|
71106487|NCT01405196|141719786|SUPERIORITY||LS mean difference|2.01|||||TWO_SIDED|90.0|-0.47|4.5||||||PCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.50|-0.47|
71079515|NCT00482170|141666459|SUPERIORITY_OR_OTHER|||||||0.549||95.0|||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.549
71079516|NCT00482170|141666460|SUPERIORITY_OR_OTHER|||||||0.158||95.0|||||Fisher Exact|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.158
71079517|NCT00482170|141666460|SUPERIORITY_OR_OTHER|||||||0.808||95.0|||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.808
71079518|NCT00482170|141666461|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Kruskal-Wallis|||p-value for statistical difference between categories, very satisfied: HAD-A, satisfied: HAD-A and less satisfied: HAD-A, in the etanercept 50 mg auto-injector group was calculated.||||0.029
71079519|NCT00482170|141666461|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Kruskal-Wallis|||p-value for statistical difference between categories, very satisfied: HAD-A, satisfied: HAD-A and less satisfied: HAD-A, in the etanercept 50 mg prefilled syringe group was calculated.||||0.005
71079520|NCT00482170|141666461|SUPERIORITY_OR_OTHER|||||||0.411||95.0|||||Kruskal-Wallis|||p-value for statistical difference between categories, very satisfied: HAD-D, satisfied: HAD-D and less satisfied: HAD-D, in the etanercept 50 mg auto-injector group was calculated.||||0.411
71079521|NCT00482170|141666461|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Kruskal-Wallis|||p-value for statistical difference between categories, very satisfied: HAD-D, satisfied: HAD-D and less satisfied: HAD-D, in the etanercept 50 mg prefilled syringe group was calculated.||||0.005
71079522|NCT00482170|141666462|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.039
71079523|NCT00482170|141666462|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.006
71079524|NCT00482170|141666463|SUPERIORITY_OR_OTHER|||||||0.752||95.0|||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.752
71079525|NCT00482170|141666463|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.700
71079526|NCT00482170|141666464|SUPERIORITY_OR_OTHER|||||||0.697||95.0|||||Fisher Exact|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.697
71079527|NCT00482170|141666464|SUPERIORITY_OR_OTHER|||||||0.159||95.0|||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.159
71079528|NCT00482170|141666465|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.004
71079529|NCT00482170|141666465|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.024
71079530|NCT00482170|141666466|SUPERIORITY_OR_OTHER|||||||0.652||95.0|||||Kruskal-Wallis|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.652
71079531|NCT00482170|141666466|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||Kruskal-Wallis|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.024
71079532|NCT00482170|141666467|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.560
71079533|NCT00482170|141666467|SUPERIORITY_OR_OTHER|||||||0.474||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.474
71079534|NCT00482170|141666468|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.023
71079535|NCT00482170|141666468|SUPERIORITY_OR_OTHER|||||||0.089||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.089
71079536|NCT00482170|141666469|SUPERIORITY_OR_OTHER|||||||0.494||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.494
71079537|NCT00482170|141666469|SUPERIORITY_OR_OTHER|||||||0.782||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.782
71079538|NCT00482170|141666470|SUPERIORITY_OR_OTHER|||||||0.444||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.444
71079539|NCT00482170|141666470|SUPERIORITY_OR_OTHER|||||||0.947||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.947
71079540|NCT00482170|141666471|SUPERIORITY_OR_OTHER|||||||0.787||95.0|||||Chi-squared|||p-value for statistical difference between categories, very satisfied: tobacco usage- yes, very satisfied: tobacco usage- no, satisfied: tobacco usage- yes, satisfied: tobacco usage- no, less satisfied: tobacco usage- yes and less satisfied: tobacco usage- no, in the etanercept 50 mg auto-injector group was calculated.||||0.787
71053928|NCT00324649|141612204|SUPERIORITY_OR_OTHER|||||||0.9713||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.9713
71053929|NCT00324649|141612205|SUPERIORITY_OR_OTHER|||||||0.9725||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.9725
71021167|NCT01507831|141550062|SUPERIORITY_OR_OTHER||LS Mean Difference|-64.8|||<|0.0001|TWO_SIDED|95.0|-67.2|-62.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-62.4|-67.2|<0.0001
71053930|NCT00324649|141612206|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.0078
71021168|NCT01507831|141550063|SUPERIORITY_OR_OTHER||LS Mean Difference|-65.5|||<|0.0001|TWO_SIDED|95.0|-67.9|-63.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-63.2|-67.9|<0.0001
71021169|NCT01507831|141550064|SUPERIORITY_OR_OTHER||LS Mean Difference|-61.3|||<|0.0001|TWO_SIDED|95.0|-64.0|-58.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-58.5|-64.0|<0.0001
71021170|NCT01507831|141550065|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.0|||<|0.0001|TWO_SIDED|95.0|-56.3|-51.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-51.7|-56.3|<0.0001
71021171|NCT01507831|141550066|SUPERIORITY_OR_OTHER||LS Mean Difference|-55.5|||<|0.0001|TWO_SIDED|95.0|-57.7|-53.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-53.2|-57.7|<0.0001
71021172|NCT01507831|141550067|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.3|||<|0.0001|TWO_SIDED|95.0|-54.4|-50.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-50.2|-54.4|<0.0001
71021173|NCT01507831|141550068|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.7|||<|0.0001|TWO_SIDED|95.0|-55.7|-51.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-51.6|-55.7|<0.0001
71021174|NCT01507831|141550069|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.5|||<|0.0001|TWO_SIDED|95.0|-39.1|-35.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-35.9|-39.1|<0.0001
71021175|NCT01507831|141550070|SUPERIORITY_OR_OTHER||LS Mean Difference|-56.0|||<|0.0001|TWO_SIDED|95.0|-58.3|-53.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-53.7|-58.3|<0.0001
71021176|NCT01507831|141550071|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.6|||<|0.0001|TWO_SIDED|95.0|-56.6|-52.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-52.6|-56.6|<0.0001
71021177|NCT01507831|141550072|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.0|||<|0.0001|TWO_SIDED|95.0|-40.4|-37.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-37.5|-40.4|<0.0001
71021178|NCT01507831|141550073|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|71.5|||<|0.0001|TWO_SIDED|95.0|51.6|99.1||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||99.1|51.6|<0.0001
71021179|NCT01507831|141550074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|93.4|||<|0.0001|TWO_SIDED|95.0|66.1|132.0||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||132.0|66.1|<0.0001
71021180|NCT01507831|141550075|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|74.6|||<|0.0001|TWO_SIDED|95.0|53.3|104.4||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||104.4|53.3|<0.0001
71021181|NCT01507831|141550076|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|97.3|||<|0.0001|TWO_SIDED|95.0|68.2|138.9||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||138.9|68.2|<0.0001
71021182|NCT01507831|141550077|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-25.6|||<|0.0001|TWO_SIDED|95.0|-28.1|-23.1||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-23.1|-28.1|<0.0001
70932674|NCT03611556|141365204|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.726|1.837|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model stratified by CD73 level with ties handled by the Efron method.|||1.837|0.726|
71053931|NCT00324649|141612207|SUPERIORITY_OR_OTHER|||||||0.6984||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: percentages of days with compliance in the two treatment groups are equal. Alternative Hypothesis: percentages of days with compliance in the two treatment groups are different (two sided).||||0.6984
71053932|NCT00324649|141612208|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.3||||0.1165||95.0|-0.9|29.4||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.|The difference is for Truvada minus zidovudine/lamivudine. The 95% confidence interval on the mean difference between treatment groups is based on the normal approximation.|"Null Hypothesis: treatment is not associated with the observed virologic response.~Alternative Hypothesis: treatment is associated with the observed virologic response."||29.4|-0.9|0.1165
71053933|NCT00324649|141612211|SUPERIORITY_OR_OTHER|||||||0.0789||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.0789
71053934|NCT00324649|141612212|SUPERIORITY_OR_OTHER|||||||0.9633||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.9633
71053935|NCT00324649|141612213|SUPERIORITY_OR_OTHER|||||||0.9686||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.9686
71053936|NCT00324649|141612214|SUPERIORITY_OR_OTHER|||||||0.6638||95.0||||No adjustments for multiple comparisons were performed.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.6638
71053937|NCT00324649|141612215|SUPERIORITY_OR_OTHER|||||||0.2907||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.2907
71053938|NCT00324649|141612216|SUPERIORITY_OR_OTHER|||||||0.0072||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.0072
71053939|NCT00324649|141612217|SUPERIORITY_OR_OTHER|||||||0.0006||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.0006
71053940|NCT00324649|141612218|SUPERIORITY_OR_OTHER|||||||0.1785||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.1785
71053941|NCT03839823|141612230|SUPERIORITY||Hazard Ratio (HR)|0.611||||0.003|TWO_SIDED|95.0|0.429|0.87|||one-sided stratified logrank test|||||0.870|0.429|0.003
71053942|NCT03839823|141612231|SUPERIORITY||Hazard Ratio (HR)|0.497||||||95.0|0.363|0.68||||||||0.680|0.363|
71053943|NCT03839823|141612232|SUPERIORITY|||||||0.02|||||||Cochran-Mantel-Haenszel|||||||0.020
71053944|NCT03839823|141612233|SUPERIORITY|||||||0.255|||||||Cochran-Mantel-Haenszel|||||||0.255
71053945|NCT03839823|141612234|SUPERIORITY|||||||0.116|||||||Cochran-Mantel-Haenszel|||||||0.116
71053946|NCT03839823|141612235|SUPERIORITY||Hazard Ratio (HR)|0.762|||||TWO_SIDED|95.0|0.546|1.064||||||||1.064|0.546|
71053947|NCT01517373|141612244|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.145||0.4468|TWO_SIDED|80.0|-0.21|0.17||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Treatment difference and 80 percent (%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment,duration of type 2 diabetes mellitus (T2DM),time and treatment-by-time interaction as fixed effects,baseline as the covariate,time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||0.17|-0.21|0.4468
71053948|NCT01517373|141612244|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.146||0.0218|TWO_SIDED|80.0|-0.48|-0.11||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||-0.11|-0.48|0.0218
71079541|NCT00482170|141666471|SUPERIORITY_OR_OTHER|||||||0.379||95.0|||||Chi-squared|||p-value for statistical difference between categories, very satisfied: tobacco usage- yes, very satisfied: tobacco usage- no, satisfied: tobacco usage- yes, satisfied: tobacco usage- no, less satisfied: tobacco usage- yes and less satisfied: tobacco usage- no, in the etanercept 50 mg prefilled syringe group was calculated.||||0.379
70932675|NCT03611556|141365204|SUPERIORITY||Hazard Ratio (HR)|0.719|||||TWO_SIDED|95.0|0.468|1.105|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model stratified by CD73 level with ties handled by the Efron method.|||1.105|0.468|
70932676|NCT03611556|141365208|SUPERIORITY||Rate difference|-1.7|||||TWO_SIDED|95.0|-25.2|21.9||||||||21.9|-25.2|
70932677|NCT03611556|141365208|SUPERIORITY||Rate difference|7.5|||||TWO_SIDED|95.0|-12.6|27.0||||||||27.0|-12.6|
70932678|NCT03611556|141365208|SUPERIORITY||Rate difference|-25.6|||||TWO_SIDED|95.0|-58.3|13.9||||||||13.9|-58.3|
71053949|NCT01517373|141612244|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.144||0.0006|TWO_SIDED|80.0|-0.65|-0.28||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||-0.28|-0.65|0.0006
71053950|NCT01517373|141612244|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.144|<|0.0001|TWO_SIDED|80.0|-1.02|-0.65||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||-0.65|-1.02|<0.0001
71053951|NCT01517373|141612245|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.087||0.6112|TWO_SIDED|80.0|-0.09|0.14||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.14|-0.09|0.6112
71053952|NCT01517373|141612245|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.088||0.055|TWO_SIDED|80.0|-0.25|-0.03||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.03|-0.25|0.0550
71053953|NCT01517373|141612245|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.086||0.0032|TWO_SIDED|80.0|-0.35|-0.13||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80%CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.13|-0.35|0.0032
71106488|NCT01405196|141719786|SUPERIORITY||LS mean difference|2.34|||||TWO_SIDED|90.0|-0.15|4.82||||||PCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.82|-0.15|
71106489|NCT01405196|141719786|SUPERIORITY||LS mean difference|2.59|||||TWO_SIDED|90.0|0.11|5.08||||||PCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.08|0.11|
71106490|NCT01405196|141719787|SUPERIORITY||LS mean difference|0.47||||||90.0|-6.33|7.27||||||Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||7.27|-6.33|
70932679|NCT03611556|141365208|SUPERIORITY||Rate difference|-6.9|||||TWO_SIDED|95.0|-39.1|26.6||||||||26.6|-39.1|
71053954|NCT01517373|141612245|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.086|<|0.0001|TWO_SIDED|80.0|-0.55|-0.33||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.33|-0.55|<0.0001
71053955|NCT01517373|141612245|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.101||0.6146|TWO_SIDED|80.0|-0.1|0.16||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.16|-0.10|0.6146
71106491|NCT01405196|141719787|SUPERIORITY||LS mean difference|3.92||||||90.0|-2.88|10.72||||||Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||10.72|-2.88|
71106492|NCT01405196|141719787|SUPERIORITY||LS mean difference|3.55|||||TWO_SIDED|90.0|-3.25|10.36||||||Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||10.36|-3.25|
71106493|NCT01405196|141719787|SUPERIORITY||LS mean difference|7.85|||||TWO_SIDED|90.0|1.05|14.66||||||Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||14.66|1.05|
70932680|NCT03611556|141365209|SUPERIORITY||Hazard Ratio (HR)|1.173|||||TWO_SIDED|95.0|0.676|1.985|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||1.985|0.676|
70932681|NCT03611556|141365209|SUPERIORITY||Hazard Ratio (HR)|0.605|||||TWO_SIDED|95.0|0.377|0.968|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||0.968|0.377|
70932682|NCT03611556|141365209|SUPERIORITY||Hazard Ratio (HR)|1.549|||||TWO_SIDED|95.0|0.622|3.917|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||3.917|0.622|
70932683|NCT03611556|141365209|SUPERIORITY||Hazard Ratio (HR)|1.472|||||TWO_SIDED|95.0|0.638|3.576|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||3.576|0.638|
70932684|NCT03611556|141365211|SUPERIORITY||Hazard Ratio (HR)|1.004|||||TWO_SIDED|95.0|0.584|1.693|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||1.693|0.584|
71021183|NCT01507831|141550078|SUPERIORITY_OR_OTHER||LS Mean Difference|4.6|||<|0.0001|TWO_SIDED|95.0|3.3|5.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.9|3.3|<0.0001
71021184|NCT01507831|141550079|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.3|||<|0.0001|TWO_SIDED|95.0|-20.1|-14.6||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-14.6|-20.1|<0.0001
71021185|NCT01507831|141550080|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|||<|0.0001|TWO_SIDED|95.0|1.6|4.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||4.2|1.6|<0.0001
71021186|NCT01507831|141550081|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-25.1|||<|0.0001|TWO_SIDED|95.0|-27.4|-22.7||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-22.7|-27.4|<0.0001
71053956|NCT01517373|141612245|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.101||0.2606|TWO_SIDED|80.0|-0.19|0.06||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.06|-0.19|0.2606
71021187|NCT01507831|141550082|SUPERIORITY_OR_OTHER||LS Mean Difference|5.6|||<|0.0001|TWO_SIDED|95.0|4.3|6.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||6.8|4.3|<0.0001
71021188|NCT01507831|141550083|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.9|||<|0.0001|TWO_SIDED|95.0|-20.5|-15.3||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-15.3|-20.5|<0.0001
71021189|NCT01507831|141550084|SUPERIORITY_OR_OTHER||LS Mean Difference|4.0|||<|0.0001|TWO_SIDED|95.0|2.8|5.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.2|2.8|<0.0001
71053957|NCT01517373|141612245|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.099||0.0006|TWO_SIDED|80.0|-0.45|-0.2||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.20|-0.45|0.0006
71021190|NCT00363129|141550110|SUPERIORITY_OR_OTHER|||||||0.43|||||||Chi-squared|||||||0.43
71021191|NCT00363129|141550111|SUPERIORITY_OR_OTHER|||||||0.49|||||||Fisher Exact|||||||0.49
71021192|NCT00363129|141550112|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
71021193|NCT02713243|141550117|SUPERIORITY||Mean Difference (Net)|4.04||||0.01|TWO_SIDED|95.0|0.98|7.11|||Mixed Models Analysis|||Week 1 (Period 1 \& 2)||7.11|0.98|0.01
71053958|NCT01517373|141612245|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|80.0|-0.7|-0.44||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.44|-0.70|<0.0001
71053959|NCT01517373|141612245|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.118||0.6618|TWO_SIDED|80.0|-0.1|0.2||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.20|-0.10|0.6618
71053960|NCT01517373|141612245|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.119||0.0878|TWO_SIDED|80.0|-0.31|-0.01||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.01|-0.31|0.0878
71053961|NCT01517373|141612245|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.117||0.0022|TWO_SIDED|80.0|-0.49|-0.19||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.19|-0.49|0.0022
71053962|NCT01517373|141612245|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.117|<|0.0001|TWO_SIDED|80.0|-0.81|-0.51||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.51|-0.81|<0.0001
71053963|NCT01517373|141612246|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.09|STANDARD_ERROR_OF_MEAN|5.222||0.3446|TWO_SIDED|80.0|-8.8|4.62||P-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||4.62|-8.80|0.3446
71053964|NCT01517373|141612246|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.12|STANDARD_ERROR_OF_MEAN|5.21||0.1204|TWO_SIDED|80.0|-12.81|0.57||P-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.57|-12.81|0.1204
71053965|NCT01517373|141612246|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.74|STANDARD_ERROR_OF_MEAN|5.166||0.0041|TWO_SIDED|80.0|-20.37|-7.1||P-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-7.10|-20.37|0.0041
71053966|NCT01517373|141612246|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.34|STANDARD_ERROR_OF_MEAN|5.192|<|0.0001|TWO_SIDED|80.0|-28.01|-14.67||P-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-14.67|-28.01|<0.0001
71053967|NCT01517373|141612246|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.14|STANDARD_ERROR_OF_MEAN|5.191||0.1616|TWO_SIDED|80.0|-11.8|1.53||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.53|-11.80|0.1616
71053968|NCT01517373|141612246|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.45|STANDARD_ERROR_OF_MEAN|5.219||0.1974|TWO_SIDED|80.0|-11.15|2.26||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.26|-11.15|0.1974
71053969|NCT01517373|141612246|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.62|STANDARD_ERROR_OF_MEAN|5.14||0.0122|TWO_SIDED|80.0|-18.22|-5.02||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-5.02|-18.22|0.0122
71053970|NCT01517373|141612246|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.79|STANDARD_ERROR_OF_MEAN|5.129|<|0.0001|TWO_SIDED|80.0|-31.37|-18.2||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-18.20|-31.37|<0.0001
71053971|NCT01517373|141612246|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.97|STANDARD_ERROR_OF_MEAN|5.674||0.3645|TWO_SIDED|80.0|-9.26|5.32||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||5.32|-9.26|0.3645
71106494|NCT01405196|141719787|SUPERIORITY||LS mean difference|7.12|||||TWO_SIDED|90.0|0.32|13.92||||||Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||13.92|0.32|
71106495|NCT01405196|141719787|SUPERIORITY||LS mean difference|4.33|||||TWO_SIDED|90.0|-2.47|11.13||||||Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||11.13|-2.47|
71106496|NCT01405196|141719787|SUPERIORITY||LS mean difference|1.33|||||TWO_SIDED|90.0|-5.4|8.05||||||Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||8.05|-5.40|
71106497|NCT01405196|141719787|SUPERIORITY||LS mean difference|3.93|||||TWO_SIDED|90.0|-2.75|10.62||||||Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||10.62|-2.75|
71106498|NCT01405196|141719787|SUPERIORITY||LS mean difference|-0.78|||||TWO_SIDED|90.0|-7.47|5.91||||||Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.91|-7.47|
70932685|NCT03611556|141365211|SUPERIORITY||Hazard Ratio (HR)|0.598|||||TWO_SIDED|95.0|0.366|0.973|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||0.973|0.366|
70932686|NCT03611556|141365211|SUPERIORITY||Hazard Ratio (HR)|1.933|||||TWO_SIDED|95.0|0.716|5.437|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||5.437|0.716|
70932687|NCT03611556|141365211|SUPERIORITY||Hazard Ratio (HR)|1.374|||||TWO_SIDED|95.0|0.55|3.707|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||3.707|0.550|
70932688|NCT03762850|141365249|OTHER||Geometric Mean Ratio|0.59|||<|0.0001|TWO_SIDED|95.0|0.51|0.69|||Mixed Models Analysis|||||0.69|0.51|<0.0001
70932689|NCT03762850|141365250|OTHER||Slope difference|1.0|STANDARD_ERROR_OF_MEAN|0.5||0.0582|TWO_SIDED|95.0|-0.03|1.94|||Mixed Models Analysis|||||1.94|-0.03|0.0582
71053972|NCT01517373|141612246|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.93|STANDARD_ERROR_OF_MEAN|5.676||0.3672|TWO_SIDED|80.0|-9.22|5.36||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||5.36|-9.22|0.3672
71053973|NCT01517373|141612246|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|5.598||0.0906|TWO_SIDED|80.0|-14.69|-0.31||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.31|-14.69|0.0906
71053974|NCT01517373|141612246|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.69|STANDARD_ERROR_OF_MEAN|5.624||0.0003|TWO_SIDED|80.0|-26.91|-12.46||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-12.46|-26.91|0.0003
71053975|NCT01517373|141612246|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.18|STANDARD_ERROR_OF_MEAN|5.534||0.1748|TWO_SIDED|80.0|-12.29|1.93||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.93|-12.29|0.1748
71053976|NCT01517373|141612246|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.54|STANDARD_ERROR_OF_MEAN|5.566||0.0297|TWO_SIDED|80.0|-17.69|-3.38||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-3.38|-17.69|0.0297
71053977|NCT01517373|141612246|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.44|STANDARD_ERROR_OF_MEAN|5.469||0.0118|TWO_SIDED|80.0|-19.47|-5.41||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-5.41|-19.47|0.0118
71053978|NCT01517373|141612246|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.0|STANDARD_ERROR_OF_MEAN|5.48|<|0.0001|TWO_SIDED|80.0|-34.04|-19.96||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-19.96|-34.04|<0.0001
71053979|NCT01517373|141612246|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.03|STANDARD_ERROR_OF_MEAN|6.281||0.1012|TWO_SIDED|80.0|-16.1|0.04||P-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.04|-16.10|0.1012
71053980|NCT01517373|141612246|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.99|STANDARD_ERROR_OF_MEAN|6.287||0.0409|TWO_SIDED|80.0|-19.07|-2.91|||t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-2.91|-19.07|0.0409
71053981|NCT01517373|141612246|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.87|STANDARD_ERROR_OF_MEAN|6.232||0.0089|TWO_SIDED|80.0|-22.88|-6.86|||t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-6.86|-22.88|0.0089
71053982|NCT01517373|141612246|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.93|STANDARD_ERROR_OF_MEAN|6.233|<|0.0001|TWO_SIDED|80.0|-33.93|-17.92||P-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-17.92|-33.93|<0.0001
71053983|NCT01517373|141612254|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.196||0.0898|TWO_SIDED|80.0|0.08|0.59||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80 percent(%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, duration of type 2 diabetes mellitus (T2DM), time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.59|0.08|0.0898
71021194|NCT02713243|141550117|SUPERIORITY||Mean Difference (Net)|1.31||||0.401|TWO_SIDED|95.0|-1.77|4.38|||Mixed Models Analysis|||Week 2 (Period 1 \& 2)||4.38|-1.77|0.401
71021195|NCT02713243|141550117|SUPERIORITY||Mean Difference (Net)|2.67||||0.019|TWO_SIDED|95.0|0.46|4.89|||Mixed Models Analysis|||Week 1\&2 (Period 1 \& 2)||4.89|0.46|0.019
71021196|NCT02713243|141550122|SUPERIORITY||Mean Difference (Net)|0.12||||0.533|TWO_SIDED|95.0|-0.27|0.52|||Mixed Models Analysis|||Week 1 (Period 1 \& 2)||0.52|-0.27|0.533
71021197|NCT02713243|141550122|SUPERIORITY||Mean Difference (Net)|-0.09||||0.64|TWO_SIDED|95.0|-0.49|0.3|||Mixed Models Analysis|||Week 2 (Period 1 \& 2)||0.30|-0.49|0.640
71021198|NCT02713243|141550122|SUPERIORITY||Mean Difference (Net)|0.02||||0.916|TWO_SIDED|95.0|-0.27|0.3|||Mixed Models Analysis|||Week 1\&2 (Period 1 \& 2)||0.30|-0.27|0.916
71021199|NCT03125915|141550124|SUPERIORITY||Beta|-3.62||||0.03|TWO_SIDED|95.0|-6.78|-0.46||A multi-level latent growth curve (LGC) with a intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-leve latent growth curve||For 1-Month Follow-Up, substance use module (SUM) among those who did not view CT Video|||-0.46|-6.78|.03
71021200|NCT03125915|141550124|SUPERIORITY||Beta|-1.67||||0.18|TWO_SIDED|95.0|-4.1|0.76||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow-up, effect of SUM among those who did view the CT video.|||0.76|-4.10|.18
71021201|NCT03125915|141550124|SUPERIORITY||Beta|-0.35||||0.75|TWO_SIDED|95.0|-2.5|1.8||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow up, effect of CT video among those who completed the SUM.|||1.80|-2.50|0.75
71021202|NCT03125915|141550124|SUPERIORITY||Beta|-2.3||||0.14|TWO_SIDED|95.0|-5.37|0.77||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-Month follow up, effect of CT video among those who did not complete SUM.|||0.77|-5.37|0.14
71021203|NCT03125915|141550124|SUPERIORITY||Beta|-2.79||||0.013|TWO_SIDED|95.0|-5.0|-0.58||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-Month follow up, effect of SUM among those who viewed the CT video.|||-0.58|-5.00|0.013
71021204|NCT03125915|141550124|SUPERIORITY||Beta|-2.09||||0.1|TWO_SIDED|95.0|-4.56|0.38||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-Month follow up, effect of SUM among those who did not view CT video|||0.38|-4.56|0.10
71021205|NCT03125915|141550124|SUPERIORITY||Beta|0.4||||0.78|TWO_SIDED|95.0|-2.35|3.16||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effect of CT Video among those who completed the SUM|A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.||3.16|-2.35|0.78
71021206|NCT03125915|141550124|SUPERIORITY||Beta|-0.3||||0.75|TWO_SIDED|95.0|-2.12|1.53||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effect of CT video among those who did not complete SUM.|||1.53|-2.12|0.75
71021207|NCT03125915|141550124|SUPERIORITY||Beta|-3.93||||0.014|TWO_SIDED|95.0|-7.06|-0.81||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effects of SUM among those who viewed the CT video.|||-0.81|-7.06|0.014
71021208|NCT03125915|141550124|SUPERIORITY||Beta|-0.57||||0.67|TWO_SIDED|95.0|-3.16|2.03||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow up, effect of SUM among those who did not view CT video.|||2.03|-3.16|0.67
71021209|NCT03125915|141550124|SUPERIORITY||Beta|-0.24||||0.83|TWO_SIDED|95.0|-2.39|1.91||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow up, effect of CT video among those who completed the SUM.|||1.91|-2.39|0.83
71021210|NCT03125915|141550124|SUPERIORITY||Beta|3.13||||0.05|TWO_SIDED|95.0|-0.004|6.25||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effects of CT video among those who did not complete SUM.|||6.25|-0.004|0.05
71053984|NCT01517373|141612254|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.195||0.0555|TWO_SIDED|80.0|0.12|0.62||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.62|0.12|0.0555
71053985|NCT01517373|141612254|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.193||0.0585|TWO_SIDED|80.0|0.12|0.61||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.61|0.12|0.0585
71053986|NCT01517373|141612254|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.194||0.0454|TWO_SIDED|80.0|0.14|0.64||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.64|0.14|0.0454
71021211|NCT03125915|141550125|SUPERIORITY||Beta|0.05||||0.9|TWO_SIDED|95.0|-2.3|2.41||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effect of SUM on the latent intercept factor among those who did not view CT videos|||2.41|-2.30|0.90
71021212|NCT03125915|141550125|SUPERIORITY||Beta|0.26||||0.78|TWO_SIDED|95.0|-2.23|2.75||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effects of CT video on the latent intercept factor among those who did not view SUM.|||2.75|-2.23|0.78
71021213|NCT03125915|141550125|SUPERIORITY||Beta|-1.18||||0.53|TWO_SIDED|95.0|-4.86|2.51||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effects of the interaction between SUM and CT video on the latent intercept.|||2.51|-4.86|0.53
71021214|NCT03125915|141550125|SUPERIORITY||Beta|1.83||||0.14|TWO_SIDED|95.0|-0.62|4.29||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effect of SUM on the latent slope factor among those who did not view CT Videos.|||4.29|-0.62|0.14
71021215|NCT03125915|141550125|SUPERIORITY||Beta|0.35||||0.76|TWO_SIDED|95.0|-2.02|2.72||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effects of CT Video on latent slope factor among those who did not complete the SUM.|||2.72|-2.02|0.76
71021216|NCT03125915|141550125|SUPERIORITY||Beta|-1.28||||0.45|TWO_SIDED|95.0|-4.62|2.06||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effects of the interaction between SUM and CT videos in the prediction of the latent slope factor.|||2.06|-4.62|0.45
71021217|NCT03125915|141550126|SUPERIORITY||Beta|-0.75||||0.02|TWO_SIDED|95.0|-1.39|-0.11||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow-up, effect of SUM among those who viewed CT videos.|||-0.11|-1.39|0.02
71053987|NCT01517373|141612254|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.235||0.2819|TWO_SIDED|80.0|-0.05|0.55||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.55|-0.05|0.2819
71053988|NCT01517373|141612254|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|0.235||0.0319|TWO_SIDED|80.0|0.2|0.81||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.81|0.20|0.0319
71106499|NCT01405196|141719787|SUPERIORITY||LS mean difference|3.67||||||90.0|-3.02|10.35||||||Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||10.35|-3.02|
71106500|NCT01405196|141719787|SUPERIORITY||LS mean difference|2.99|||||TWO_SIDED|90.0|-3.7|9.68||||||Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||9.68|-3.70|
70932690|NCT03762850|141365251|OTHER||Slope difference|1.1|STANDARD_ERROR_OF_MEAN|0.52||0.0369|TWO_SIDED|95.0|0.07|2.12|||Mixed Models Analysis|||||2.12|0.07|0.0369
70932691|NCT02036970|141365278|SUPERIORITY||Mean Difference (Net)|-1.74||||0.8133|TWO_SIDED|95.0|-16.22|12.74||The p-value comparison is for the difference in the change in 6WMD from baseline at Week 16 for bardoxolone methyl relative to placebo in participants with pulmonary arterial hypertension (PAH).|Mixed Models Analysis||Mean difference (Net) = Bardoxolone methyl - Placebo.|Overall treatment effect in participants with PAH. Mean overall treatment effect across all visits for change from baseline in 6MWD was estimated and compared with placebo through 16 weeks of treatment using mixed-model repeated measures (MMRM), with treatment group, visit, and the interaction between treatment and visit as fixed factors. A compound symmetry covariance matrix was assumed. Data from Wks 4, 8, 12, and 16 used in the model with the change from baseline at Wk16 as primary endpoint.||12.74|-16.22|0.8133
70941635|NCT04748445|141383934|OTHER||Slope|2.816|STANDARD_ERROR_OF_MEAN|1.026||0.007|TWO_SIDED|90.0|1.115|4.516|||Mixed Models Analysis|||EE\_MFCC std 04 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||4.516|1.115|0.0070
71021218|NCT03125915|141550126|SUPERIORITY||Beta|-0.49||||0.1|TWO_SIDED|95.0|-1.07|0.09||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow-up, effect of SUM among those who did not view CT videos.|||0.09|-1.07|0.10
71021219|NCT03125915|141550126|SUPERIORITY||Beta|-0.15||||0.63|TWO_SIDED|95.0|-0.77|0.47||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow-up, effects of CT video among those who completed SUM.|||0.47|-0.77|0.63
71021220|NCT03125915|141550126|SUPERIORITY||Beta|-0.41||||0.19|TWO_SIDED|95.0|-1.01|0.2||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow-up, effects of CT video among those who did not complete SUM.|||0.20|-1.01|0.19
71021221|NCT03125915|141550126|SUPERIORITY||Beta|-0.64||||0.01|TWO_SIDED|95.0|-1.13|-0.15||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effect of SUM among those who completed the CT video.|||-0.15|-1.13|0.01
71021222|NCT03125915|141550126|SUPERIORITY||Beta|-0.49||||0.12|TWO_SIDED|95.0|-1.11|0.12||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effects of SUM among those who did not complete CT video.|||0.12|-1.11|0.12
71106501|NCT01405196|141719787|SUPERIORITY||LS mean difference|1.44|||||TWO_SIDED|90.0|-5.24|8.13||||||Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||8.13|-5.24|
71106502|NCT01405196|141719788|SUPERIORITY||LS mean difference|0.53|||||TWO_SIDED|90.0|-2.53|3.59||||||MCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.59|-2.53|
70851345|NCT00669409|141190547|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|7.73|||TWO_SIDED|95.0|-23.1|7.4||||||Change at Week 2, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.4|-23.1|
71106503|NCT01405196|141719788|SUPERIORITY||LS mean difference|-0.48|||||TWO_SIDED|90.0|-3.54|2.58||||||MCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.58|-3.54|
70941636|NCT04748445|141383934|OTHER||Slope|0.007814|STANDARD_ERROR_OF_MEAN|1.034||0.4513|TWO_SIDED|90.0|-0.009323|0.02495|||Mixed Models Analysis|||EE\_MFCC std 05 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.02495|-0.009323|0.4513
71021223|NCT03125915|141550126|SUPERIORITY||Beta|-0.34||||0.23|TWO_SIDED|95.0|-0.89|0.21||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effects of CT video among those who completed SUM.|||0.21|-0.89|0.23
71021224|NCT03125915|141550126|SUPERIORITY||Beta|-0.19||||0.51|TWO_SIDED|95.0|-0.76|0.38||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effect of CT video among those who did not complete SUM.|||0.38|-0.76|0.51
71106504|NCT01405196|141719788|SUPERIORITY||LS mean difference|1.28|||||TWO_SIDED|90.0|-1.78|4.34||||||MCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.34|-1.78|
71106505|NCT01405196|141719788|SUPERIORITY||LS mean difference|1.78|||||TWO_SIDED|90.0|-1.28|4.84||||||MCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.84|-1.28|
71106506|NCT01405196|141719788|SUPERIORITY||LS mean difference|1.2|||||TWO_SIDED|90.0|-1.86|4.26||||||MCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.26|-1.86|
71106507|NCT01405196|141719788|SUPERIORITY||LS mean difference|0.09|||||TWO_SIDED|90.0|-2.98|3.15||||||MCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.15|-2.98|
71106508|NCT01405196|141719788|SUPERIORITY||LS mean difference|0.0|||||TWO_SIDED|90.0|-3.03|3.03||||||MCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.03|-3.03|
70851346|NCT00669409|141190547|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|10.25|||TWO_SIDED|95.0|-23.3|17.2||||||Change at Week 2, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.2|-23.3|
70932692|NCT02036970|141365278|SUPERIORITY||Mean Difference (Net)|-3.17||||0.759|TWO_SIDED|95.0|-23.54|17.2||The p-value comparison is for the difference in the change in 6WMD from baseline at Week 16 for bardoxolone methyl relative to placebo in participants with pulmonary hypertension (PH)|Mixed Models Analysis||Mean difference (Net) = Bardoxolone methyl - Placebo.|Overall treatment effect in participants with PH. Mean overall treatment effect across all visits for change from baseline in 6MWD was estimated \& compared with placebo through 16 wks of treatment using mixed-model repeated measures (MMRM), with treatment group, visit, and the interaction between treatment \& visit as fixed factors. Compound symmetry covariance matrix was assumed. Data from Wks 4, 8, 12, and 16 were used in the model with the change from baseline at Wk 16 as the primary endpoint||17.20|-23.54|0.759
70932693|NCT00979459|141365279|NON_INFERIORITY_OR_EQUIVALENCE|Administration of a single dose of two 40 mg MK-1006 FCT is similar to a single dose of four 20 mg MK-1006 DFC will be satisfied if the 90% confidence interval for the AUC(0 to infinity) geometric mean ratio (FCT/DCF) is contained within (0.70, 1.43).|Geometric mean ratio|0.93|||||TWO_SIDED|90.0|0.86|0.99||||||||0.99|0.86|
70932694|NCT00979459|141365280|NON_INFERIORITY_OR_EQUIVALENCE|Administration of a single dose of two 40 mg MK-1006 FCT is similar to a single dose of four 20 mg MK-1006 DFC will be satisfied if the 90% confidence interval for the Cmax geometric mean ratio (FCT/DCF) is contained within (0.70, 1.43).|Geometric mean ratio|1.07|||||TWO_SIDED|90.0|0.92|1.24||||||||1.24|0.92|
70932695|NCT02298842|141365283|NON_INFERIORITY|The sample size of 60 was chosen to meet the FDA pH requirements that the lower 95% confidence limit on the proportion of platelet test units with pH\> 6.2 will be at least 95%. This will be achieved if zero failures (pH\<=6.2) is seen.|Simple sample proportion|100.0|STANDARD_DEVIATION|0.0|||ONE_SIDED|95.0|95.1||||Exact Binomial Confidence Interval||Estimated proportion is 100%. Hence standard deviation is estimated as 0.|"A success is defined as pH22°C at Day 5 and Day 7 being at least 6.2. A one-sided 95% lower confidence limit will be used to assess the proportion of successes at Day 5 and Day 7. If the lower limit of the one-sided 95% confidence interval exceeds 0.95, the Test product will meet the FDA acceptance criteria."|||95.1|
71021225|NCT03125915|141550126|SUPERIORITY||Beta|-0.79||||0.003|TWO_SIDED|95.0|-1.32|-0.27||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effects of SUM among those who viewed CT videos.|||-0.27|-1.32|0.003
71021226|NCT03125915|141550126|SUPERIORITY||Beta|-0.25||||0.49|TWO_SIDED|95.0|-0.96|0.46||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effect of SUM among those who did not view the CT video.|||0.46|-0.96|0.49
71021227|NCT03125915|141550126|SUPERIORITY||Beta|-0.53||||0.1|TWO_SIDED|95.0|-1.16|0.11||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effect of CT video among those who completed SUM.|||0.11|-1.16|0.10
71021228|NCT03125915|141550126|SUPERIORITY||Beta|-0.02||||0.96|TWO_SIDED|95.0|-0.6|0.64||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effect of CT video among those who did not complete SUM.|||0.64|-0.60|0.96
71053989|NCT01517373|141612254|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.231||0.1835|TWO_SIDED|80.0|0.01|0.6||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.60|0.01|0.1835
71053990|NCT01517373|141612254|SUPERIORITY_OR_OTHER||LS Mean Difference|0.93|STANDARD_ERROR_OF_MEAN|0.231||0.0001|TWO_SIDED|80.0|0.63|1.22||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.22|0.63|0.0001
71053991|NCT01517373|141612254|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.266||0.9689|TWO_SIDED|80.0|-0.35|0.33||P-value was 2-sided.|t-test, 2 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.33|-0.35|0.9689
71053992|NCT01517373|141612254|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.265||0.2221|TWO_SIDED|80.0|-0.02|0.67||P-value was 2-sided.|t-test, 2 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.67|-0.02|0.2221
71021229|NCT02517099|141550141|SUPERIORITY||Median Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.384||0.05|TWO_SIDED|95.0|1.591|8.8|||Wilcoxon (Mann-Whitney)|||||8.80|1.591|0.05
71053993|NCT01517373|141612254|SUPERIORITY_OR_OTHER||LS Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|0.261||0.2774|TWO_SIDED|80.0|-0.05|0.62||P-value was 2-sided.|t-test, 2 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.62|-0.05|0.2774
71053994|NCT01517373|141612254|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|STANDARD_ERROR_OF_MEAN|0.263|<|0.0001|TWO_SIDED|80.0|0.76|1.43||P-value was 2-sided.|t-test, 2 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.43|0.76|<0.0001
71106509|NCT01405196|141719788|SUPERIORITY||LS mean difference|-0.09|||||TWO_SIDED|90.0|-3.09|2.92||||||MCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.92|-3.09|
71021230|NCT01123980|141550145|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered to be confirmed if the upper bound of the two-sided 95% confidence interval (CI) was below or equal to 0.4% or equivalent if the p-value for the one-sided test of H0: D \> 0.4% against HA: D =\< 0.4%, was less than or equal to 2.5%, where D is the mean treatment difference (investigational product minus comparator). Furthermore, superiority of BIAsp 30 OD over insulin glargine OD was shown if the upper limit of the 95% CI for the difference is lower than 0%|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.07|<|0.001||95.0|-0.25|0.02||The p-values correspond to one-sided hypotheses of either non-inferiority or superiority, statistical significance level is 2.5%.|ANCOVA|The estimates are from a normal linear regression model with treatment, country and previous OADs as factors and baseline HbA1c as a covariate||H0: The mean treatment difference (BIAsp 30 minus insulin glargine) \> 0.4%. HA: The mean treatment difference (BIAsp 30 minus insulin glargine) =\< 0.4%. Sample size was calculated to achieve a power of at least 90%, assuming an equal change in HbA1c and a common standard deviation of 1.25%||0.02|-0.25|< 0.001
71021231|NCT01123980|141550146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|||<|0.001||95.0|-0.24|0.19||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Before breakfast|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||0.19|-0.24|<0.001
71021232|NCT01123980|141550146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|||<|0.001||95.0|-0.45|0.58||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Two hours after breakfast|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||0.58|-0.45|<0.001
71021233|NCT01123980|141550146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||<|0.001||95.0|-0.31|0.58||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Before lunch|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||0.58|-0.31|<0.001
71021234|NCT01123980|141550146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|||<|0.001||95.0|-0.26|0.82||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Two hours after lunch|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||0.82|-0.26|<0.001
71021235|NCT01123980|141550146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64|||<|0.001||95.0|0.22|1.06||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Before dinner|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||1.06|0.22|<0.001
71021236|NCT01123980|141550146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51|||<|0.001||95.0|-2.03|-1.0||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Two hours after dinner|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||-1.00|-2.03|<0.001
71021237|NCT01123980|141550146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25|||<|0.001||95.0|-1.73|-0.78||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Bedtime|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||-0.78|-1.73|<0.001
71021238|NCT01123980|141550146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||<|0.001||95.0|-0.81|-0.13||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||02 - 04 a.m.|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||-0.13|-0.81|<0.001
71021239|NCT01123980|141550146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||<|0.001||95.0|-0.06|0.4||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Before breakfast the following day|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||0.40|-0.06|<0.001
71021240|NCT01123980|141550147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8583||95.0|0.64|1.46|||Regression, Logistic||The odds ratio and 95% confidence interval is for the HbA1c less than 7% treatment target were included.|The responder analysis was based on logistic regression model using treatment, country and previous OAD therapy (with or without a third OAD) as factors and baseline HbA1c as covariate.||1.46|0.64|0.8583
71053995|NCT01517373|141612254|SUPERIORITY_OR_OTHER||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.314||0.0667|TWO_SIDED|80.0|0.17|0.98||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.98|0.17|0.0667
71053996|NCT01517373|141612254|SUPERIORITY_OR_OTHER||LS Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|0.314||0.0133|TWO_SIDED|80.0|0.38|1.19||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.19|0.38|0.0133
71053997|NCT01517373|141612254|SUPERIORITY_OR_OTHER||LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.308||0.026|TWO_SIDED|80.0|0.29|1.08||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.08|0.29|0.0260
71053998|NCT01517373|141612254|SUPERIORITY_OR_OTHER||LS Mean Difference|1.63|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|80.0|1.23|2.02||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.02|1.23|<0.0001
70932696|NCT02298842|141365284|NON_INFERIORITY|The sample size of 60 was chosen to meet the FDA pH requirements that the lower 95% confidence limit on the proportion of platelet test units with pH\> 6.2 will be at least 95%. This will be achieved if zero failures (pH\<=6.2) is seen.|Simple sample proportion|100.0|STANDARD_DEVIATION|0.0|||ONE_SIDED|95.0|95.1||||Exact Bionomial Confidence Interval||Estimated proportion is 100%. Hence standard deviation is estimated as 0.|"A success is defined as pH22°C at Day 5 and Day 7 being at least 6.2. A one-sided 95% lower confidence limit will be used to assess the proportion of successes at Day 5 and Day 7. If the lower limit of the one-sided 95% confidence interval exceeds 0.95, the Test product will meet the FDA acceptance criteria."|||95.1|
70932697|NCT02298842|141365285|NON_INFERIORITY|If the 97.5% upper limit of the confidence interval is less than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|15.099|STANDARD_DEVIATION|5.6367|||ONE_SIDED|97.5||16.738|||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that P-selectin's mean difference, Test - 1.25 \* Control, is greater than or equal to 0, and the alternative is that the mean difference is less than 0.||16.738||
70932698|NCT02298842|141365286|NON_INFERIORITY|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Median Difference (Final Values)|-0.418|STANDARD_DEVIATION|4.5531|||ONE_SIDED|97.5|-1.544||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that ESC's mean difference, Test - 0.8 \* Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|||-1.544|
70932699|NCT02298842|141365287|NON_INFERIORITY|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|-0.667|STANDARD_DEVIATION|6.7882|||ONE_SIDED|97.5|-2.499||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that HSR's mean difference, Test - 0.8 \* Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|||-2.499|
71053999|NCT01517373|141612254|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.374||0.0335|TWO_SIDED|80.0|0.32|1.28||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.28|0.32|0.0335
71054000|NCT01517373|141612254|SUPERIORITY_OR_OTHER||LS Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.373||0.1557|TWO_SIDED|80.0|0.05|1.01||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.01|0.05|0.1557
71054001|NCT01517373|141612254|SUPERIORITY_OR_OTHER||LS Mean Difference|0.92|STANDARD_ERROR_OF_MEAN|0.368||0.0132|TWO_SIDED|80.0|0.45|1.39||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.39|0.45|0.0132
71054002|NCT01517373|141612254|SUPERIORITY_OR_OTHER||LS Mean Difference|2.68|STANDARD_ERROR_OF_MEAN|0.37|<|0.0001|TWO_SIDED|80.0|2.2|3.15||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||3.15|2.20|<0.0001
71054003|NCT01517373|141612254|SUPERIORITY_OR_OTHER||LS Mean Difference|0.96|STANDARD_ERROR_OF_MEAN|0.394||0.0158|TWO_SIDED|80.0|0.45|1.46||P-value was 2-sided.|t-test, 2 sided|||Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.46|0.45|0.0158
71054004|NCT01517373|141612254|SUPERIORITY_OR_OTHER||LS Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|0.392||0.2132|TWO_SIDED|80.0|-0.01|0.99||P-value was 2-sided.|t-test, 2 sided|||Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.99|-0.01|0.2132
71054005|NCT01517373|141612254|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86|STANDARD_ERROR_OF_MEAN|0.387||0.0263|TWO_SIDED|80.0|0.37|1.36||P-value was 2-sided.|t-test, 2 sided|||Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.36|0.37|0.0263
71054006|NCT01517373|141612254|SUPERIORITY_OR_OTHER||LS Mean Difference|2.62|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|80.0|2.12|3.12||P-value was 2-sided.|t-test, 2 sided|||Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||3.12|2.12|<0.0001
71054007|NCT00790335|141612315|SUPERIORITY||Risk Ratio (RR)|0.96||||0.56|TWO_SIDED|95.0|0.82|1.11|||Cochran-Mantel-Haenszel|Adjusted for extent of DVT and for clinical center|Numerator: PCDT Arm; Denominator: Control Arm. Primary outcome = no statistically significant difference between the two arms.|||1.11|0.82|0.56
71054008|NCT00790335|141612316|SUPERIORITY||Risk Ratio (RR)|0.58||||0.38|TWO_SIDED|95.0|0.17|1.98|||Cochran-Mantel-Haenszel|Adjusted by extent of thrombus and clinical center|Numerator: PCDT Arm; Denominator: Control Arm. No statistically significant difference was seen.|||1.98|0.17|0.38
71021241|NCT01123980|141550148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.8013||95.0|0.64|1.79|||Regression, Logistic||The odds ratio and 95% confidence interval is for the HbA1c below or equal to 6.5% treatment target were included.|The responder analysis was based on logistic regression model using treatment, country and previous OAD therapy (with or without a third OAD) as factors and baseline HbA1c as covariate.||1.79|0.64|0.8013
71021242|NCT02094937|141550168|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.31|2.49||||||||2.49|0.31|
71021243|NCT02094937|141550168|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.28|2.19||||||||2.19|0.28|
71021244|NCT02094937|141550169|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93|||||TWO_SIDED|95.0|0.9|4.12||||||||4.12|0.90|
71021245|NCT02094937|141550169|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45|||||TWO_SIDED|95.0|0.66|3.2||||||||3.20|0.66|
71021246|NCT01133392|141550176|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.99|||||TWO_SIDED|90.0|0.948|1.034||||||||1.034|0.948|
71021247|NCT01133392|141550177|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.933|||||TWO_SIDED|90.0|0.897|0.972||||||||0.972|0.897|
71021248|NCT01133392|141550178|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|1.005|||||TWO_SIDED|90.0|0.958|1.054||||||||1.054|0.958|
71021249|NCT01133392|141550179|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.1|||||TWO_SIDED|90.0|-0.4|0.5||||||||0.500|-0.400|
71054009|NCT00790335|141612317|SUPERIORITY||Risk Ratio (RR)|0.94||||0.39|TWO_SIDED|95.0|0.8|1.09|||Cochran-Mantel-Haenszel|Adjusted for thrombus extent and clinical center|No statistically significant difference was seen.|||1.09|0.80|0.39
71021250|NCT01133392|141550180|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|1.014|||||TWO_SIDED|90.0|0.961|1.07||||||||1.070|0.961|
71021251|NCT05788237|141550192|OTHER||GMR|0.84|||||TWO_SIDED|95.0|0.662|1.062||||||GMR for RSV A: RSVpreF + qIRV combination to RSVpreF alone.||1.062|0.662|
71021252|NCT05788237|141550192|OTHER||GMR|0.79|||||TWO_SIDED|95.0|0.614|1.013||||||GMR for RSV B: RSVpreF + qIRV combination to RSVpreF alone.||1.013|0.614|
71021253|NCT05788237|141550193|OTHER||GMR|0.81|||||TWO_SIDED|95.0|0.632|1.044||||||GMR for HAI: H1N1 A/Wisconsin: RSVpreF + qIRV combination to RSVpreF alone.||1.044|0.632|
71021254|NCT05788237|141550193|OTHER||Geometric Mean Ratio|0.74|||||TWO_SIDED|95.0|0.567|0.957||||||GMR for HAI: H3N2 A/Darwin: RSVpreF + qIRV combination to RSVpreF alone.||0.957|0.567|
71021255|NCT05788237|141550193|OTHER||GMR|0.94|||||TWO_SIDED|95.0|0.741|1.181||||||GMR for HAI: B/Austria: RSVpreF + qIRV combination to RSVpreF alone.||1.181|0.741|
71021256|NCT05788237|141550193|OTHER||GMR|0.91|||||TWO_SIDED|95.0|0.707|1.174||||||GMR for HAI: B/Phuket: RSVpreF + qIRV combination to RSVpreF alone.||1.174|0.707|
71021257|NCT05788237|141550194|OTHER||Geometric Mean Ratio|1.05|||||TWO_SIDED|95.0|0.82|1.339||||||GMR for RSV A: RSVpreF + qIRV 1.0 mL (Group 1) combination to RSVpreF + qIRV 0.5 mL (Group 2)||1.339|0.820|
71021258|NCT05788237|141550194|OTHER||Geometric Mean Ratio|1.06|||||TWO_SIDED|95.0|0.833|1.352||||||GMR for RSV B: RSVpreF + qIRV 1.0 mL (Group 1) to RSVpreF + qIRV 0.5 mL (Group 2)||1.352|0.833|
71021259|NCT05788237|141550195|OTHER||GMR|1.19|||||TWO_SIDED|95.0|0.875|1.614||||||GMR for HAI: H1N1 A/Sydney: RSVpreF + qIRV 1.0 mL (Group 1) to RSVpreF + qIRV 0.5 mL (Group 2)||1.614|0.875|
71021260|NCT05788237|141550195|OTHER||Geometric Mean Ratio|1.13|||||TWO_SIDED|95.0|0.867|1.473||||||GMR for HAI: H3N2 A/Darwin: RSVpreF + qIRV 1.0 mL (Group 1) to RSVpreF + qIRV 0.5 mL (Group 2)||1.473|0.867|
71021261|NCT05788237|141550195|OTHER||Geometric Mean Ratio|1.08|||||TWO_SIDED|95.0|0.849|1.383||||||GMR for HAI: B/Austria: RSVpreF + qIRV 1.0 mL (Group 1) to RSVpreF + qIRV 0.5 mL (Group 2)||1.383|0.849|
71021262|NCT05788237|141550195|OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.866|1.392||||||GMR for HAI: B/Phuket: RSVpreF + qIRV 1.0 mL (Group 1) to RSVpreF + qIRV 0.5 mL (Group 2)||1.392|0.866|
71021263|NCT00207714|141550211|SUPERIORITY_OR_OTHER|||||||0.01||||||A positive test is concluded if there is a significant difference between combined golimumab and placebo groups and at least one of the pair-wise comparisons at 0.05 level.|Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Week 16 between combined golimumab groups and Placebo +MTX group. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25 % response in Placebo +MTX.||||0.010
71021264|NCT00207714|141550211|SUPERIORITY_OR_OTHER|||||||0.056|||||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 16 between golimumab 50 mg every 4 weeks and Placebo + MTX. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25% response in placebo.||||0.056
71021265|NCT00207714|141550211|SUPERIORITY_OR_OTHER|||||||0.281|||||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 16 between Golimumab 50 mg every 2 or 4 Weeks and Placebo + MTX. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25% response in placebo.||||0.281
70932700|NCT02298842|141365288|NON_INFERIORITY|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|46.1|STANDARD_DEVIATION|23.056|||ONE_SIDED|97.5|40.02||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that Morphology's mean difference, Test - 0.8 \* Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|||40.020|
70932701|NCT02298842|141365289|NON_INFERIORITY|Lower value is considered to indicate better platelet quality. If the 97.5% upper limit of the confidence interval is less than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|12.314|STANDARD_DEVIATION|6.0422|||ONE_SIDED|97.5||13.981|||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that P-selection's mean difference, Test - 1.25 \* Control, is greater or equal to 0, and the alternative is that the mean difference is less than 0.||13.981||
70932702|NCT02298842|141365290|NON_INFERIORITY|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|-3.042|STANDARD_DEVIATION|5.422|||ONE_SIDED|97.5|-4.407||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that ESC's mean difference, Test - 0.8 \* Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|||-4.407|
70932703|NCT02298842|141365291|NON_INFERIORITY|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|-2.389|STANDARD_DEVIATION|9.0544|||ONE_SIDED|97.5|-4.915||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that HSR's mean difference, Test - 0.8 \* Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|||-4.915|
70932704|NCT02298842|141365292|NON_INFERIORITY|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|43.8|STANDARD_DEVIATION|26.05|||ONE_SIDED|97.5|36.821||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that Morphology's mean difference, Test - 0.8 \* Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|||36.821|
71021266|NCT00207714|141550211|SUPERIORITY_OR_OTHER|||||||0.119|||||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 16 between Golimumab 100 mg every 4 weeks and Placebo + MTX. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25% response in placebo.||||0.119
71021267|NCT00207714|141550211|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 16 between Golimumab 100 mg every 2 or 4 Weeks and Placebo + MTX. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25% response in placebo.||||<0.001
71021268|NCT00207714|141550212|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA on van der Waerden normal scores.|||No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX and combined golimumab groups.||||0.001
70932705|NCT04503681|141365321|SUPERIORITY||Median Difference (Final Values)|0.0||||0.473|TWO_SIDED|95.0|-1.1|1.1|||Wilcoxon (Mann-Whitney)|||||1.1|-1.1|0.473
70932706|NCT04503681|141365322|SUPERIORITY||Median Difference (Final Values)|0.0||||0.338|TWO_SIDED|95.0|-0.8|0.8|||Wilcoxon (Mann-Whitney)|||||0.8|-0.8|0.338
70932707|NCT03849937|141365344|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
70932708|NCT03849937|141365344|SUPERIORITY|||||||0.091||||||Time 1 to Time 2|t-test, 2 sided|||||||.091
70932709|NCT03849937|141365344|SUPERIORITY||||||<|0.001||||||Time 2 to Time 3|t-test, 2 sided|||||||<.001
70932710|NCT03849937|141365345|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Effective Communication||||<.001
71054010|NCT00790335|141612318|SUPERIORITY||Risk Ratio (RR)|0.73||||0.04|TWO_SIDED|95.0|0.54|0.98|||Cochran-Mantel-Haenszel|Adjusted by extent of DVT and clinical center|Numerator: PCDT Arm; Denominator: Control Arm|||0.98|0.54|0.04
71054011|NCT00790335|141612319|SUPERIORITY||Risk Ratio (RR)|6.18||||0.049|TWO_SIDED|95.0|0.78|49.2|||Cochran-Mantel-Haenszel||Numerator: PCDT Arm; Denominator: Control Arm. More major bleeding was observed in the PCDT Arm.|||49.2|0.78|0.049
71054012|NCT00790335|141612320|SUPERIORITY||Risk Ratio (RR)|1.52||||0.23|TWO_SIDED|95.0|0.76|3.01|||Cochran-Mantel-Haenszel||Numerator: PCDT Arm; Denominator: Control Arm|||3.01|0.76|0.23
71054013|NCT00790335|141612321|SUPERIORITY||Risk Ratio (RR)|2.64||||0.03|TWO_SIDED|95.0|1.04|6.68|||Cochran-Mantel-Haenszel||Numerator = PCDT Arm; Denominator = Control Arm. Bleeding was more frequent in the PCDT Arm.|||6.68|1.04|0.03
70932711|NCT03849937|141365345|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Appropriate Communication||||<.001
71054014|NCT00790335|141612322|SUPERIORITY||Risk Ratio (RR)|1.26||||0.25|TWO_SIDED|95.0|0.85|1.89|||Cochran-Mantel-Haenszel||Numerator: PCDT Arm; Denominator: Control Arm|||1.89|0.85|0.25
70932712|NCT03849937|141365345|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Recognizes elderspeak||||<.001
70932713|NCT03849937|141365345|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Recognizes person-centered communication||||<.001
71021269|NCT00207714|141550212|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA on van der Waerden normal scores.|||No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX and Golimumab 50 mg every 4 weeks||||0.006
71054015|NCT00790335|141612323|SUPERIORITY||Risk Ratio (RR)|1.53||||0.5|TWO_SIDED|95.0|0.44|5.28|||Cochran-Mantel-Haenszel||Numerator = PCDT Arm; Denominator = Control Arm|||5.28|0.44|0.50
71054016|NCT00790335|141612324|SUPERIORITY||Risk Ratio (RR)|1.47||||0.09|TWO_SIDED|95.0|0.94|2.29|||Cochran-Mantel-Haenszel||Numerator: PCDT Arm; Denominator: Control Arm|||2.29|0.94|0.09
71054017|NCT00790335|141612326|SUPERIORITY||Risk Ratio (RR)|0.89||||0.83|TWO_SIDED|95.0|0.33|2.44|||Cochran-Mantel-Haenszel|||||2.44|0.33|0.83
71054018|NCT00790335|141612327|SUPERIORITY||Mean Difference (Net)|-1.22|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||< 0.001
71054019|NCT00790335|141612328|SUPERIORITY||Mean Difference (Net)|-1.17|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||< 0.001
71054020|NCT00790335|141612329|SUPERIORITY||Mean Difference (Net)|-1.12|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||< 0.001
71054021|NCT00790335|141612330|SUPERIORITY||Mean Difference (Net)|-1.06|STANDARD_ERROR_OF_MEAN|0.38||0.005|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||0.005
71054022|NCT00790335|141612331|SUPERIORITY||Mean Difference (Net)|-0.95|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||< 0.001
71054023|NCT00790335|141612332|SUPERIORITY||Mean Difference (Net)|-0.56|STANDARD_ERROR_OF_MEAN|0.23||0.01|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||0.01
71054024|NCT00790335|141612333|SUPERIORITY||Mean Difference (Net)|-1.06|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||< 0.001
71054025|NCT00790335|141612334|SUPERIORITY||Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|0.26||0.03|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||0.03
71054026|NCT00790335|141612335|SUPERIORITY||Mean Difference (Net)|1.13|STANDARD_ERROR_OF_MEAN|1.26||0.37|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center|No significant difference was seen in the degree of change from baseline to 24 months between the two treatment arms.|||||0.37
71106510|NCT01405196|141719788|SUPERIORITY||LS mean difference|-0.02|||||TWO_SIDED|90.0|-3.03|2.99||||||MCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.99|-3.03|
71054027|NCT00790335|141612336|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|1.16||0.99|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center|No difference was observed in the degree of change from baseline to 24 months in the two treatment groups.|||||0.99
71054028|NCT00790335|141612337|SUPERIORITY||Mean Difference (Net)|4.2|STANDARD_ERROR_OF_MEAN|2.39||0.08|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center|No significant difference in the change from baseline to 24 months between the two treatment arms.|||||0.08
71054029|NCT00790335|141612338|SUPERIORITY||Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.14||0.02|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center||||||0.02
71054030|NCT00790335|141612339|SUPERIORITY||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|0.15||0.03|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center||||||0.03
71054031|NCT00790335|141612340|SUPERIORITY||Mean Difference (Net)|-0.53|STANDARD_ERROR_OF_MEAN|0.23||0.02|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center||||||0.02
71054032|NCT00790335|141612341|SUPERIORITY||Mean Difference (Net)|-0.46|STANDARD_ERROR_OF_MEAN|0.23||0.05|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center||||||0.05
71054033|NCT04516759|141612347|SUPERIORITY||Risk Ratio (RR)|1.09||||0.1854|TWO_SIDED|95.0|0.9|1.32|||Chi-squared|Chi-squared test on the one-sided significance level of 2.5%||||1.32|0.9|0.1854
71054034|NCT04516759|141612348|OTHER|||||||0.0286||||||Baseline p-value|Wilcoxon (Mann-Whitney)|one-side significance level of 2.5%||||||0.0286
71054035|NCT04516759|141612348|OTHER|||||||0.0786||||||Day 7 p-value|Wilcoxon (Mann-Whitney)|one-side significance level of 2.5%||||||0.0786
71054036|NCT04516759|141612348|OTHER|||||||0.2169||||||Day 14 p-value|Wilcoxon (Mann-Whitney)|one-side significance level of 2.5%||||||0.2169
71054037|NCT04516759|141612348|OTHER|||||||0.186||||||Day 21 p-value|Wilcoxon (Mann-Whitney)|one-sided significance level of 2.5%||||||0.1860
71054038|NCT04516759|141612348|OTHER|||||||0.2256||||||Study Drug Discontinuation (SDD) p-value|Wilcoxon (Mann-Whitney)|one-sided significance level of 2.5%||||||0.2256
71054039|NCT04516759|141612349|OTHER|||||||0.4006||||||Increase in Diabetic Medication needed equal or more than 3 days|Fisher Exact|||||||0.4006
71054040|NCT04516759|141612349|OTHER|||||||0.7482||||||Diabetic Medication is stable/reduced equal or more than 3 days|Fisher Exact|||||||0.7482
71054041|NCT04516759|141612349|OTHER|||||||0.6949||||||Increase in Diabetic Medication needed at any time during the study|Fisher Exact|||||||0.6949
71054042|NCT04516759|141612349|OTHER|||||||0.5521||||||Diabetic Medication is stable/reduced at any time during the study|Fisher Exact|||||||0.5521
71054043|NCT04516759|141612350|OTHER|||||||0.5875|||||||Fisher Exact|||||||0.5875
71054044|NCT04516759|141612351|OTHER|||||||0.1129|||||||Fisher Exact|||||||0.1129
71054045|NCT04516759|141612352|SUPERIORITY|||||||0.1556|||||||Log Rank|||||||0.1556
71054046|NCT04516759|141612353|OTHER||Risk Ratio (RR)|0.41||||0.0903|TWO_SIDED|95.0|0.13|1.26|||Fisher Exact|The p-value is assessed by means of an Fisher's exact test on the one-sided significance level of 2.5%||||1.26|0.13|0.0903
70932714|NCT05405244|141365382|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||Snack intake||||0.45
70932715|NCT05405244|141365382|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||Milkshake intake||||0.28
70932716|NCT05405244|141365383|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||Pleasantness||||0.89
70932717|NCT05405244|141365383|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Desire to consume||||<0.001
70932718|NCT04191824|141365444|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.7769|TWO_SIDED|95.0|-2.7|2.1||In order to maintain an overall alpha of 0.05 and account for two interim analyses, a two-sided alpha of 0.0492 was used for assessing the statistical significance in the final analysis of this primary endpoint.|t-test, 2 sided|||||2.1|-2.7|0.7769
71021270|NCT00207714|141550212|SUPERIORITY_OR_OTHER|||||||0.095|||||||ANOVA on van der Waerden normal scores.|||No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX and Golimumab 50 mg every 2 or 4 Weeks||||0.095
70932719|NCT04191824|141365445|SUPERIORITY||Risk Difference (RD)|0.106|||<|0.0001|TWO_SIDED|95.0|0.061|0.151|||Chi-squared|||||0.151|0.061|<0.0001
70932720|NCT04191824|141365446|SUPERIORITY||Risk Difference (RD)|0.057||||0.0753|TWO_SIDED|95.0|-0.006|0.12|||Chi-squared|||||0.120|-0.006|0.0753
70932721|NCT04191824|141365447|SUPERIORITY||Risk Difference (RD)|0.002||||0.8044|TWO_SIDED|95.0|-0.013|0.016|||Chi-squared|||||0.016|-0.013|0.8044
70932722|NCT04191824|141365448|SUPERIORITY||Risk Difference (RD)|-0.052||||0.057|TWO_SIDED|95.0|-0.105|0.002|||Chi-squared|||||0.002|-0.105|0.0570
70932723|NCT04191824|141365449|SUPERIORITY||Risk Difference (RD)|0.045||||0.0012|TWO_SIDED|95.0|0.018|0.072|||Chi-squared|||||0.072|0.018|0.0012
70932724|NCT04191824|141365450|SUPERIORITY||Risk Difference (RD)|-0.006||||0.8483|TWO_SIDED|95.0|-0.066|0.055|||Chi-squared|||||0.055|-0.066|0.8483
70932725|NCT02646618|141365469|NON_INFERIORITY|We set δ=2% as a relative margin to the 5% weight loss as clinically meaningful cut point and because 2% is not so small a difference in average weight loss between study conditions that we would have to recruit a prohibitively large sample.|Mean Difference (Net)|2.0||||0.0038|TWO_SIDED|95.0|0.6|3.3|||Mixed Models Analysis|||||3.3|0.6|0.0038
71021271|NCT00207714|141550212|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANOVA on van der Waerden normal scores.|ANOVA on van der Waerden normal scores||No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX Golibumab 100 mg every 4 weeks||||0.010
70932726|NCT02646618|141365470|NON_INFERIORITY|We set δ=2% as a relative margin to the 5% weight loss as clinically meaningful cut point and because 2% is not so small a difference in average weight loss between study conditions that we would have to recruit a prohibitively large sample.|Mean Difference (Net)|1.2||||0.1485|TWO_SIDED|95.0|-0.4|2.8|||Mixed Models Analysis|||||2.8|-0.4|0.1485
70932727|NCT02646618|141365472|SUPERIORITY|||||||0.248|||||||t-test, 2 sided|||||||0.2480
70932728|NCT02646618|141365477|NON_INFERIORITY|For secondary noninferiority outcomes, we used 90% power to calculate noninferiority margins given N=131 per arm, setting alpha=.05 and using observed SDs from the literature. For change in energy (kcal/day) intake, the study is powered at 90% to detect whether the Get Social condition is not inferior to the Traditional condition with a noninferiority margin of 182 kcal/day (SD=500 kcal/day)|Mean Difference (Net)|93.0||||0.2025|TWO_SIDED|95.0|-50.0|237.0|||Mixed Models Analysis|||||237|-50|0.2025
70941637|NCT04748445|141383934|OTHER||Slope|1.151|STANDARD_ERROR_OF_MEAN|8.443||0.1753|TWO_SIDED|90.0|-2.483|2.55|||Mixed Models Analysis|||EE\_MFCC std 06 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and estimated value it was 10\^-2. For lower limit and dispersion value it was 10\^-3).||2.550|-2.483|0.1753
71021272|NCT00207714|141550212|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on van der Waerden normal scores.|||No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX Golimumab 100 mg every 2 or 4 Weeks||||<0.001
71054047|NCT04516759|141612354|OTHER|||||||0.6144|||||||Fisher Exact|One-sided significance level of 2.5%||||||0.6144
71054048|NCT04516759|141612355|OTHER|||||||0.0105|||||||Fisher Exact|one-sided significance level of 2.5%||||||0.0105
71054049|NCT04516759|141612356|OTHER|||||||0.062|||||||Fisher Exact|one-sided significance level of 2.5%||||||0.062
71054050|NCT04005352|141612357|SUPERIORITY||||||<|0.0001|ONE_SIDED|||||with significance level of 0.025|Wilcoxon (Mann-Whitney)|||||||<0.0001
71054051|NCT04005352|141612358|NON_INFERIORITY|4 letter margin (1-sided)|Difference|0.1|STANDARD_ERROR_OF_MEAN|0.73|<|0.0001|TWO_SIDED|95.0|-1.3|1.5|||ANOVA|||||1.5|-1.3|<0.0001
71054052|NCT04005352|141612359|SUPERIORITY||||||<|0.0001|ONE_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71054053|NCT04005352|141612360|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71054054|NCT04005352|141612361|SUPERIORITY|Week 14|Odds Ratio (OR)|1.6||||0.051|TWO_SIDED|95.0|0.9|2.7|||likelihood ratio test|Assessed at one-sided 0.025 significance level||||2.7|0.9|0.0510
71054055|NCT04005352|141612361|SUPERIORITY|Week 16|Odds Ratio (OR)|2.6|||<|0.0001|TWO_SIDED|95.0|1.7|3.9|||likelihood ratio test|Assessed at one-sided 0.025 significance level||||3.9|1.7|<0.0001
71054056|NCT04005352|141612364|SUPERIORITY||Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.84||0.8137|TWO_SIDED|95.0|-1.9|1.5||p-value for treatment difference|ANOVA|||||1.5|-1.9|0.8137
71054057|NCT04005352|141612365|SUPERIORITY|Week 32|Odds Ratio (OR)|1.0||||0.4106|TWO_SIDED|95.0|0.7|1.3|||likelihood ratio test|adjusting for baseline BCVA categories (\<55, 55-\<73, ≥73 letters).||||1.3|0.7|0.4106
71054058|NCT04005352|141612365|SUPERIORITY|Week 64|Odds Ratio (OR)|1.0||||0.4667|TWO_SIDED|95.0|0.7|1.4|||likelihood ratio test|adjusting for baseline BCVA categories (\<55, 55-\<73, ≥73 letters).||||1.4|0.7|0.4667
71054059|NCT04005352|141612366|SUPERIORITY|Week 32|Odds Ratio (OR)|1.1||||0.2397|TWO_SIDED|95.0|0.8|1.7|||likelihood ratio test|assessed at the 0.025 significance level||||1.7|0.8|0.2397
71021273|NCT02580318|141550216|OTHER||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (poor effort)|t-test, 2 sided|||this p value is calculated for poor effort||||<0.0001
71021274|NCT02580318|141550216|OTHER||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (hyperventilation - immediate)|t-test, 2 sided|||p value calculated for hyperventilation (immediate)||||<0.0001
71021275|NCT02580318|141550216|OTHER||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (5 minutes after hyperventilation)|t-test, 2 sided|||p value calculated for hyperventilation (after 5 minutes)||||<0.0001
71021276|NCT02580318|141550216|OTHER||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (10 minutes after hyperventilation)|t-test, 2 sided|||p value calculated for hyperventilation (after 10 minutes)||||<0.0001
71021277|NCT02580318|141550216|OTHER||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (immediately after drinking water)|t-test, 2 sided|||p value calculated for drinking water (immediate)||||<0.0001
71021278|NCT02580318|141550216|OTHER||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (5 minutes after drinking water)|t-test, 2 sided|||p value calculated for drinking water (5 minutes)||||<0.0001
71021279|NCT01735877|141550224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|1.52||0.77|||||||t-test, 2 sided|||At Baseline||||0.77
71021280|NCT01735877|141550224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.12|||<|0.0001|TWO_SIDED|95.0|11.02|17.25|||ANCOVA|||Mean Change from baseline to 1 month||17.25|11.02|<0.0001
71021281|NCT01735877|141550224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.56|||<|0.0001|TWO_SIDED|95.0|18.65|26.48|||ANCOVA|||Baseline to 3 month||26.48|18.65|<0.0001
71021282|NCT01735877|141550224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.28|||<|0.0001|TWO_SIDED|95.0|18.94|27.62|||ANCOVA|||Baseline to 6 month||27.62|18.94|<0.0001
71021283|NCT01735877|141550225|SUPERIORITY_OR_OTHER|||||||0.99|||||||Chi-squared|||At Baseline||||0.99
71021284|NCT01735877|141550225|SUPERIORITY_OR_OTHER|||||||0.99|||||||Chi-squared|||At 1 month||||0.99
71021285|NCT01735877|141550225|SUPERIORITY_OR_OTHER|||||||0.03|||||||Chi-squared|||At 3 months||||0.03
71021286|NCT01735877|141550225|SUPERIORITY_OR_OTHER|||||||0.004|||||||Chi-squared|||At 6 months||||0.004
71021287|NCT01735877|141550226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51|STANDARD_ERROR_OF_MEAN|3.25||0.64|||||||t-test, 2 sided|||At Baseline||||0.64
71021288|NCT01735877|141550226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.92||||0.002|TWO_SIDED|95.0|2.24|9.6|||ANCOVA|||Mean change from baseline to 1 month||9.60|2.24|0.002
71021289|NCT01735877|141550226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.71||||0.005|TWO_SIDED|95.0|2.8|14.63|||ANCOVA|||Mean change from baseline to 3 month||14.63|2.80|0.005
71021290|NCT01735877|141550226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.63||||0.006|TWO_SIDED|95.0|2.67|14.6|||ANCOVA|||Mean change from baseline to 6 month||14.60|2.67|0.006
71054060|NCT04005352|141612366|SUPERIORITY|Week 64|Odds Ratio (OR)|1.2||||0.115|TWO_SIDED|95.0|0.9|1.8|||likelihood ratio test|assessed at the 0.025 significance level||||1.8|0.9|0.1150
71021291|NCT01735877|141550227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.24||0.99|||||||t-test, 2 sided|||Baseline||||0.99
71021292|NCT01735877|141550227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.68|||<|0.0001|TWO_SIDED|95.0|2.93|4.42|||ANCOVA|||Mean change from baseline to 1 month||4.42|2.93|<0.0001
71021293|NCT01735877|141550227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.41|||<|0.0001|TWO_SIDED|95.0|2.61|4.21|||ANCOVA|||Mean change from baseline to 3 month||4.21|2.61|<0.0001
71021294|NCT01735877|141550227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.21|||<|0.0001|TWO_SIDED|95.0|2.4|4.02|||ANCOVA|||Mean change from baseline to 6 month||4.02|2.40|<0.0001
71021295|NCT01735877|141550228|SUPERIORITY_OR_OTHER|||||||0.99|||||||Chi-squared|||At Baseline||||0.99
71021296|NCT01735877|141550228|SUPERIORITY_OR_OTHER|||||||0.99|||||||Chi-squared|||At month 1||||0.99
71021297|NCT01735877|141550228|SUPERIORITY_OR_OTHER|||||||0.04|||||||Chi-squared|||At month 3||||0.04
71021298|NCT01735877|141550228|SUPERIORITY_OR_OTHER|||||||0.01|||||||Chi-squared|||At month 6||||0.01
71021299|NCT02082912|141550238|SUPERIORITY||F statistic|0.216||||0.651|TWO_SIDED||||||ANOVA|||Values represent the time x treatment group interaction.||||0.651
71021300|NCT02082912|141550239|SUPERIORITY||F statistic|0.633||||0.447|TWO_SIDED||||||ANOVA|||Values represent the time x treatment group interaction.||||0.447
71021301|NCT02082912|141550240|SUPERIORITY||F statistic|0.557||||0.471|TWO_SIDED||||||ANOVA|||Values represent the time x treatment group interaction.||||0.471
71021302|NCT04126733|141550274|EQUIVALENCE|H0: ORR ≤ 5% versus H1: ORR \>5% The hypothesis was tested by a one-sided exact binomial test, assuming a background response rate for the combination to be at most 5%.|Rate|7.1||||0.2721||95.0|2.4|15.9||The target response rate for the combination treatment was 17%. Using a one-sided exact binomial test at a type-I error of at most 2.5% at least 8 responders out of the 70 patients were needed to achieve significance.|Exact Binomial Test|||||15.9|2.4|0.2721
71021303|NCT02629133|141550288|SUPERIORITY|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||||||0.560
71021304|NCT02629133|141550288|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Differences between conditions in the change in % heavy drinking/using days from baseline to 6 months||||0.760
71021305|NCT02629133|141550289|SUPERIORITY|||||||0.026|||||||Wilcoxon (Mann-Whitney)|||||||0.026
71021306|NCT02629133|141550289|SUPERIORITY|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||Distributions were badly skewed, and the sample was too small for ZINB or other analyses. Therefore, we analyzed differences between conditions in changes in services/day over time (i.e., from baseline to 6 month post-shelter follow-up) using the Mann-Whitney U.||||0.029
71021307|NCT02629133|141550290|SUPERIORITY||Mean Difference (Final Values)|4.5||||0.325|TWO_SIDED|95.0|-4.5|13.5||We used hierarchical linear modeling (HLM) to predict 3-mo and 6-mo post-shelter scores from treatment condition, using baseline score as a covariate.|Mixed Models Analysis|||||13.5|-4.5|0.325
71054061|NCT04005352|141612367|SUPERIORITY|Weeks 28 and 32|Difference|-26.9|STANDARD_ERROR_OF_MEAN|9.87||0.0066|TWO_SIDED|95.0|-46.3|-7.5|||ANOVA|||||-7.5|-46.3|0.0066
71021308|NCT02629133|141550291|SUPERIORITY||Mean Difference (Final Values)|1.19||||0.192|TWO_SIDED|95.0|-0.61|2.98||We used HLM to predict Cyber-Stalking Scores across 3 and 6 month post shelter follow-up points from treatment condition, using baseline score as a covariate.|Mixed Models Analysis||Higher scores represent more cyber-stalking over follow-up.|||2.98|-0.61|0.192
71021309|NCT02629133|141550292|SUPERIORITY||Mean Difference (Final Values)|-1.43||||0.119|TWO_SIDED|95.0|-3.24|0.38||We conducted HLM predicting SBC Total scores at 3 and 6 months post-shelter release from treatment condition, using baseline SBC score as a covariate.|Mixed Models Analysis||Higher is better (reflecting more safety behaviors used).|||0.38|-3.24|0.119
71021310|NCT02354976|141550305|OTHER||Geometric mean ratio for difference|0.92||||0.407|TWO_SIDED|95.0|0.76|1.12|||Mixed Models Analysis|||||1.12|0.76|0.407
71054062|NCT04005352|141612367|SUPERIORITY|Weeks 60 and 64|Difference|-15.4|STANDARD_ERROR_OF_MEAN|11.26||0.1714|TWO_SIDED|95.0|-37.6|6.7|||ANOVA|||||6.7|-37.6|0.1714
71054063|NCT04005352|141612370|SUPERIORITY|Week 32|LS Mean Difference|0.37||||0.193|TWO_SIDED|95.0|-0.2|0.9|||ANCOVA|||||0.9|-0.2|0.193
71054064|NCT04005352|141612370|SUPERIORITY|Week 64|LS Mean Difference|-2.0||||0.052|TWO_SIDED|95.0|-3.9|0.0|||ANCOVA|||||0.0|-3.9|0.052
71054065|NCT04005352|141612371|SUPERIORITY|Week 32|LS Mean Difference|2.16||||0.081|TWO_SIDED|95.0|-0.3|4.6|||ANCOVA|||||4.6|-0.3|0.081
71054066|NCT04005352|141612371|SUPERIORITY|Week 64|LS Mean Difference|-0.7||||0.59|TWO_SIDED|95.0|-3.2|1.8|||ANCOVA|||||1.8|-3.2|0.590
71054067|NCT04005352|141612372|SUPERIORITY|Week 32|LS Mean Difference|0.77||||0.558|TWO_SIDED|95.0|-1.8|3.4|||ANCOVA|||||3.4|-1.8|0.558
71021311|NCT02354976|141550306|OTHER||Geometric mean ratio for difference|0.84||||0.077|TWO_SIDED|95.0|0.7|1.02|||Mixed Models Analysis|||||1.02|0.70|0.077
71021312|NCT03726437|141550307|SUPERIORITY|Analyses were performed to determine whether RealConsent was superior to Stress and Mood Management in reducing incidence of sexual violence victimization.|Risk Ratio (RR)|0.48||||0.0002|TWO_SIDED|95.0|0.33|0.69|||Mixed Models Analysis|Models adjusted for fixed effects.||||.69|.33|.0002
71021313|NCT03726437|141550307|SUPERIORITY||Odds Ratio (OR)|0.77||||0.31|TWO_SIDED|95.0|0.47|1.28|||Mixed Models Analysis|Models adjusted for fixed effects.||||1.28|.47|.31
71021314|NCT03726437|141550308|SUPERIORITY||Adjusted OR|1.17||||0.03|TWO_SIDED|95.0|0.12|1.22|||Mixed Models Analysis|Model adjusted for fixed effects.||||1.22|0.12|.03
71054068|NCT04005352|141612372|SUPERIORITY|Week 64|LS Mean Difference|-1.9||||0.138|TWO_SIDED|95.0|-4.5|0.6|||ANCOVA|||||0.6|-4.5|0.138
71054069|NCT04005352|141612373|SUPERIORITY|Week 32|LS Mean Difference|1.6||||0.287|TWO_SIDED|95.0|-1.4|4.6|||ANCOVA|||||4.6|-1.4|0.287
71054070|NCT04005352|141612373|SUPERIORITY|Week 64|LS Mean Difference|-3.0||||0.07|TWO_SIDED|95.0|-6.2|0.2|||ANCOVA|||||0.2|-6.2|0.070
71054071|NCT04005352|141612374|SUPERIORITY|Week 32|LS Mean Difference|-0.71||||0.602|TWO_SIDED|95.0|-3.4|2.0|||ANCOVA|||||2.0|-3.4|0.602
71054072|NCT04005352|141612374|SUPERIORITY|Week 64|LS Mean Difference|-2.5||||0.086|TWO_SIDED|95.0|-5.3|0.4|||ANCOVA|||||0.4|-5.3|0.086
71054073|NCT04005352|141612375|SUPERIORITY|Week 32|LS Mean Difference|1.55||||0.174|TWO_SIDED|95.0|-0.7|3.8|||ANCOVA|||||3.8|-0.7|0.174
71054074|NCT04005352|141612375|SUPERIORITY|Week 64|LS Mean Difference|-1.5||||0.21|TWO_SIDED|95.0|-3.8|0.8|||ANCOVA|||||0.8|-3.8|0.210
71054075|NCT04005352|141612376|SUPERIORITY|Week 32|LS Mean Difference|-0.96||||0.499|TWO_SIDED|95.0|-3.8|1.8|||ANCOVA|||||1.8|-3.8|0.499
71054076|NCT04005352|141612376|SUPERIORITY|Week 64|LS Mean Difference|-2.3||||0.147|TWO_SIDED|95.0|-5.4|0.8|||ANCOVA|||||0.8|-5.4|0.147
71054077|NCT04005352|141612377|SUPERIORITY|Week 32|LS Mean Difference|0.88||||0.643|TWO_SIDED|95.0|-2.8|4.6|||ANCOVA|||||4.6|-2.8|0.643
71054078|NCT04005352|141612377|SUPERIORITY|Week 64|LS Mean Difference|-1.3||||0.507|TWO_SIDED|95.0|-5.0|2.5|||ANCOVA|||||2.5|-5.0|0.507
71054079|NCT04005352|141612378|SUPERIORITY|Week 32|LS Mean Difference|0.49||||0.7|TWO_SIDED|95.0|-2.0|3.0|||ANCOVA|||||3.0|-2.0|0.700
71054080|NCT04005352|141612378|SUPERIORITY|Week 64|LS Mean Difference|-2.9||||0.07|TWO_SIDED|95.0|-6.0|0.2|||ANCOVA|||||0.2|-6.0|0.070
71054081|NCT04005352|141612379|SUPERIORITY|Week 32|LS Mean Difference|0.73||||0.741|TWO_SIDED|95.0|-3.6|5.1|||ANCOVA|||||5.1|-3.6|0.741
71054082|NCT04005352|141612379|SUPERIORITY|Week 64|LS Mean Difference|-1.7||||0.494|TWO_SIDED|95.0|-6.6|3.2|||ANCOVA|||||3.2|-6.6|0.494
71054083|NCT04005352|141612380|SUPERIORITY|Week 32|LS Mean Difference|1.76||||0.054|TWO_SIDED|95.0|0.0|3.5|||ANCOVA|||||3.5|-0.0|0.054
71054084|NCT04005352|141612380|SUPERIORITY|Week 64|LS Mean Difference|-1.1||||0.331|TWO_SIDED|95.0|-3.4|1.2|||ANCOVA|||||1.2|-3.4|0.331
71054085|NCT04005352|141612381|SUPERIORITY|Week 32|LS Mean Difference|1.24||||0.394|TWO_SIDED|95.0|-1.6|4.1|||ANCOVA|||||4.1|-1.6|0.394
71054086|NCT04005352|141612381|SUPERIORITY|Week 64|LS Mean Difference|-0.5||||0.728|TWO_SIDED|95.0|-3.6|2.5|||ANCOVA|||||2.5|-3.6|0.728
71079542|NCT00482170|141666471|SUPERIORITY_OR_OTHER|||||||0.098||95.0|||||Chi-squared|||p-value for statistical difference between categories, very satisfied: alcohol usage- yes, very satisfied: alcohol usage- no, satisfied: alcohol usage- yes, satisfied: alcohol usage- no, less satisfied: alcohol usage- yes and less satisfied: alcohol usage- no, in the etanercept 50 mg auto-injector group was calculated.||||0.098
71021315|NCT03726437|141550309|SUPERIORITY||Adjusted OR|-0.5|||<|0.05|TWO_SIDED|95.0|-1.27|0.27|||Mixed Models Analysis|Model adjusted for fixed effects.||||0.27|-1.27|<.05
71021316|NCT03726437|141550310|SUPERIORITY||Incidence rate ratio|0.81||||0.02|TWO_SIDED|95.0|0.67|0.97|||Mixed Models Analysis|Model adjusted for fixed effects.||||.97|.67|.02
71021317|NCT03726437|141550311|SUPERIORITY||Incidence rate ratio|1.05||||0.43|TWO_SIDED|95.0|0.92|1.2|||Mixed Models Analysis|Model adjusted for fixed effects.||||1.20|.92|.43
71106511|NCT01405196|141719788|SUPERIORITY||LS mean difference|-0.16|||||TWO_SIDED|90.0|-3.17|2.85||||||MCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.85|-3.17|
71021318|NCT03726437|141550312|SUPERIORITY||Adjusted OR|1.72||||0.006|TWO_SIDED|95.0|1.17|2.55|||Mixed Models Analysis|Model adjusted for fixed effects.||||2.55|1.17|.006
71021319|NCT03118765|141550322|OTHER|ANOVA|LS mean ratio (%)|29.4|||||TWO_SIDED|90.0|21.14|41.0|||||Relative Bioavailability (%) based on CmaxSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on CmaxSS was tested and the estimated treatment ratios for the treatment comparisons was presented.||41.00|21.14|
71021320|NCT03118765|141550322|OTHER|ANOVA|LS mean ratio (%)|57.0|||||TWO_SIDED|90.0|41.37|78.46|||||Relative Bioavailability (%) based on CmaxSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on CmaxSS was tested and the estimated treatment ratios for the treatment comparisons was presented.||78.46|41.37|
71021321|NCT03118765|141550322|OTHER|ANOVA|LS mean ratio (%)|155.8|||||TWO_SIDED|90.0|111.88|216.99|||||Relative Bioavailability (%) based on CmaxSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on CmaxSS was tested and the estimated treatment ratios for the treatment comparisons was presented.||216.99|111.88|
71021322|NCT03118765|141550323|OTHER|ANOVA|LS mean ratio (%)|39.7|||||TWO_SIDED|90.0|29.79|52.87|||||Relative Bioavailability (%) based on AUC0-tauSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on AUC0-tauSS was tested and the estimated treatment ratios for the treatment comparisons was presented.||52.87|29.79|
71021323|NCT03118765|141550323|OTHER|ANOVA|LS mean ratio (%)|85.2|||||TWO_SIDED|90.0|64.43|112.64|||||Relative Bioavailability (%) based on AUC0-tauSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on AUC0-tauSS was tested and the estimated treatment ratios for the treatment comparisons was presented.||112.64|64.43|
71021324|NCT03118765|141550323|OTHER|ANOVA|LS mean ratio (%)|211.5|||||TWO_SIDED|90.0|158.8|281.8|||||Relative Bioavailability (%) based on AUC0-tauSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on AUC0-tauSS was tested and the estimated treatment ratios for the treatment comparisons was presented.||281.80|158.80|
71021325|NCT03118765|141550324|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.228|TWO_SIDED|95.0|-0.04|0.17|||MMRM|||GSP 304 vs Placebo comparison for change from baseline in trough FEV1 was tested at 0.05 significance level.||0.17|-0.04|0.228
71021326|NCT03118765|141550324|SUPERIORITY||Mean Difference (Net)|0.02||||0.655|TWO_SIDED|95.0|-0.08|0.13|||MMRM|||GSP 304 vs Placebo comparison for change from baseline in trough FEV1 was tested at 0.05 significance level.||0.13|-0.08|0.655
71021327|NCT03118765|141550324|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.894|TWO_SIDED|95.0|-0.1|0.11|||MMRM|||GSP 304 vs Placebo comparison for change from baseline in trough FEV1 was tested at 0.05 significance level.||0.11|-0.10|0.894
71021328|NCT03118765|141550324|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.26|TWO_SIDED|95.0|-0.04|0.16|||MMRM|||SPIRIVA RESPIMAT 5 μg vs Placebo comparison for change from baseline in trough FEV1 was tested at 0.05 significance level.||0.16|-0.04|0.260
71021329|NCT03118765|141550325|OTHER||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 1 for GSP304 10 μg was (Geo mean: 108200 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 120300 pg).|||
71021330|NCT03118765|141550325|OTHER||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 1 for GSP304 20 μg was (Geo mean: 263100 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 120300 pg).|||
71021331|NCT03118765|141550325|OTHER||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 1 for GSP304 40 μg was (Geo mean: 438300 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 120300 pg).|||
71021332|NCT03118765|141550326|OTHER||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 21 for GSP304 10 μg was (Geo mean: 293700 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 620200 pg).|||
71021333|NCT03118765|141550326|OTHER||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 21 for GSP304 20 μg was (Geo mean: 436500 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 620200 pg).|||
71021334|NCT03118765|141550326|OTHER||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 21 for GSP304 40 μg was (Geo mean: 1249000 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 620200 pg).|||
71021335|NCT03118765|141550327|OTHER||||||||||||||||||For GSP304 10 μg, the geometric mean Fe (%) eliminated in urine was 1.082% on Day 1 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 2.407% on Day 1|||
71021336|NCT03118765|141550327|OTHER||||||||||||||||||For GSP304 20 μg, the geometric mean Fe (%) eliminated in urine was 1.316% on Day 1 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 2.407% on Day 1|||
71021337|NCT03118765|141550327|OTHER||||||||||||||||||For GSP304 40 μg, the geometric mean Fe (%) eliminated in urine was 1.096% on Day 1 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 2.407% on Day 1|||
71021338|NCT03118765|141550328|OTHER||||||||||||||||||For GSP304 10 μg, the geometric mean Fe (%) eliminated in urine was 2.937% on Day 21 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 12.4% on Day 21|||
71021339|NCT03118765|141550328|OTHER||||||||||||||||||For GSP304 20 μg, the geometric mean Fe (%) eliminated in urine was 2.183% on Day 21 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 12.4% on Day 21|||
71021340|NCT03118765|141550328|OTHER||||||||||||||||||For GSP304 40 μg, the geometric mean Fe (%) eliminated in urine was 3.123% on Day 21 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 12.4% on Day 21|||
71021341|NCT03118765|141550329|OTHER||||||||||||||||||For GSP304 10 μg, geometric mean Cmax of tiotropium was 2.191 pg/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean Cmax of tiotropium was 7.327 pg/mL on Day 1.|||
71106512|NCT01405196|141719788|SUPERIORITY||LS mean difference|-1.58|||||TWO_SIDED|90.0|-4.58|1.43||||||MCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||1.43|-4.58|
71106513|NCT01405196|141719788|SUPERIORITY||LS mean difference|-0.71|||||TWO_SIDED|90.0|-3.72|2.3||||||MCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.30|-3.72|
71106514|NCT01405196|141719788|SUPERIORITY||LS mean difference|2.67|||||TWO_SIDED|90.0|0.14|5.2||||||PCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.20|0.14|
70932729|NCT02646618|141365478|NON_INFERIORITY|For secondary noninferiority outcomes, we used 90% power to calculate noninferiority margins given N=131 per arm, setting alpha=.05 and using observed SDs from the literature. For change in energy (kcal/day) intake, the study is powered at 90% to detect whether the Get Social condition is not inferior to the Traditional condition with a noninferiority margin of 182 kcal/day (SD=500 kcal/day)|Mean Difference (Net)|-75.0||||0.3323|TWO_SIDED|95.0|-226.0|77.0|||Mixed Models Analysis|||||77|-226|0.3323
70932730|NCT02646618|141365480|NON_INFERIORITY|For secondary noninferiority outcomes, we used 90% power to calculate noninferiority margins given N=131 per arm, setting alpha=.05 and using observed SDs from the literature. For change in moderate to vigorous intensity physical activity minutes per day at 12 months, the noninferiority margin is 9.2 min/day(SD=25 min/day). However, we could not analyze the data in that manner and used the test described above.||||||0.3905|||||||Generalized estimating equation|||We examined the proportion of participants engaging in 150+ minutes/week of moderate/vigorous intensity physical activity (MVPA) using generalized estimating equations with a logit link function and incorporating repeated measures over time. For participants missing MVPA at either follow-up timepoint, we used a baseline observation carried forward approach to impute their activity level (150+ vs \<150 MVPA mins/week) at that timepoint.||||0.3905
70941638|NCT04748445|141383934|OTHER||Slope|2.528|STANDARD_ERROR_OF_MEAN|8.228||0.0026|TWO_SIDED|90.0|1.164|3.891|||Mixed Models Analysis|||EE\_MFCC std 07 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and estimated value it was 10\^-2. For dispersion it was 10\^-3).||3.891|1.164|0.0026
71021342|NCT03118765|141550329|OTHER||||||||||||||||||For GSP304 20 μg, geometric mean Cmax of tiotropium was 4.796 pg/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean Cmax of tiotropium was 7.327 pg/mL on Day 1.|||
71021343|NCT03118765|141550329|OTHER||||||||||||||||||For GSP304 40 μg, geometric mean Cmax of tiotropium was 10.2 pg/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean Cmax of tiotropium was 7.327 pg/mL on Day 1.|||
71021344|NCT03118765|141550330|OTHER||||||||||||||||||For GSP304 10 μg, geometric mean AUC0-tau of tiotropium was 8.597 pg\*h/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean AUC0-tau of tiotropium was 19.59 pg\*h/mL on Day 1.|||
71021345|NCT03118765|141550330|OTHER||||||||||||||||||For GSP304 20 μg, geometric mean AUC0-tau of tiotropium was 18.00 pg\*h/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean AUC0-tau of tiotropium was 19.59 pg\*h/mL on Day 1.|||
71021346|NCT03118765|141550330|OTHER||||||||||||||||||For GSP304 40 μg, geometric mean AUC0-tau of tiotropium was 42.69 pg\*h/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean AUC0-tau of tiotropium was 19.59 pg\*h/mL on Day 1.|||
71021347|NCT03118765|141550333|OTHER||||||||||||||||||For GSP304 10 μg, the geometric mean CavSS was 0.9536 pg/mL on Day 21 and for SPIRIVA RESPIMAT 5 μg, the CavSS was 2.403 pg/mL on Day 21|||
71021348|NCT03118765|141550333|OTHER||||||||||||||||||For GSP304 20 μg, the geometric mean CavSS was 1.998 pg/mL on Day 21 and for SPIRIVA RESPIMAT 5 μg, the CavSS was 2.403 pg/mL on Day 21|||
71021349|NCT03118765|141550333|OTHER||||||||||||||||||For GSP304 40 μg, the geometric mean CavSS was 5.083 pg/mL on Day 21 and for SPIRIVA RESPIMAT 5 μg, the CavSS was 2.403 pg/mL on Day 21|||
71021350|NCT03118765|141550334|OTHER||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on AUC of 2.617 for GSP304 10 μg and 2.815 for SPIRIVA RESPIMAT 5 μg.|||
71021351|NCT03118765|141550334|OTHER||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on AUC of 2.522 for GSP304 20 μg and 2.815 for SPIRIVA RESPIMAT 5 μg.|||
71021352|NCT03118765|141550334|OTHER||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on AUC of 2.926 for GSP304 40 μg and 2.815 for SPIRIVA RESPIMAT 5 μg.|||
71021353|NCT03118765|141550335|OTHER||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on Cmax of 1.944 for GSP304 10 μg and 1.929 for SPIRIVA RESPIMAT 5 μg.|||
71021354|NCT03118765|141550335|OTHER||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on Cmax of 1.808 for GSP304 20 μg and 1.929 for SPIRIVA RESPIMAT 5 μg.|||
71021355|NCT03118765|141550335|OTHER||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on Cmax of 2.125 for GSP304 40 μg and 1.929 for SPIRIVA RESPIMAT 5 μg.|||
71077922|NCT02913105|141664399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.84||||0.0002|TWO_SIDED|90.0|0.78|0.9|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 84||0.90|0.78|0.0002
71077923|NCT02913105|141664399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.95||||0.228|TWO_SIDED|90.0|0.89|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 112 (EOS)||1.02|0.89|0.2280
71106515|NCT01405196|141719788|SUPERIORITY||LS mean difference|3.36|||||TWO_SIDED|90.0|0.84|5.89||||||PCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.89|0.84|
71106516|NCT01405196|141719788|SUPERIORITY||LS mean difference|3.23|||||TWO_SIDED|90.0|0.7|5.76||||||PCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.76|0.70|
71106517|NCT01405196|141719788|SUPERIORITY||LS mean difference|3.77|||||TWO_SIDED|90.0|1.24|6.3||||||PCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||6.30|1.24|
71106518|NCT01405196|141719788|SUPERIORITY||LS mean difference|3.1|||||TWO_SIDED|90.0|0.57|5.63||||||PCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.63|0.57|
71106519|NCT01405196|141719788|SUPERIORITY||LS mean difference|3.03||||||90.0|0.5|5.56||||||PCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.56|0.50|
71106520|NCT01405196|141719788|SUPERIORITY||LS mean difference|1.96|||||TWO_SIDED|90.0|-0.53|4.46||||||PCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.46|-0.53|
71021356|NCT03118765|141550336|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.004|TWO_SIDED|95.0|0.04|0.21|||Mixed Models Analysis|||||0.21|0.04|0.004
71021357|NCT03118765|141550336|SUPERIORITY||Mean Difference (Final Values)|0.17|||<|0.001|TWO_SIDED|95.0|0.08|0.26|||Mixed Models Analysis|||||0.26|0.08|<0.001
71106521|NCT01405196|141719788|SUPERIORITY||LS mean difference|2.68||||||90.0|0.2|5.17||||||PCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.17|0.20|
71021358|NCT03118765|141550336|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.007|TWO_SIDED|95.0|0.03|0.21|||Mixed Models Analysis|||||0.21|0.03|0.007
71021359|NCT03118765|141550336|SUPERIORITY||Mean Difference (Final Values)|0.17|||<|0.001|TWO_SIDED|95.0|0.08|0.26|||Mixed Models Analysis|||||0.26|0.08|<0.001
71021360|NCT03118765|141550337|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.001|TWO_SIDED|95.0|0.08|0.28|||Mixed Models Analysis|||||0.28|0.08|0.001
71021361|NCT03118765|141550337|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.005|TWO_SIDED|95.0|0.05|0.25|||Mixed Models Analysis|||||0.25|0.05|0.005
71021362|NCT03118765|141550337|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.032|TWO_SIDED|95.0|0.01|0.21|||Mixed Models Analysis|||||0.21|0.01|0.032
71021363|NCT03118765|141550337|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.001|TWO_SIDED|95.0|0.07|0.27|||Mixed Models Analysis|||||0.27|0.07|0.001
71021364|NCT03118765|141550338|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.166|TWO_SIDED|95.0|-0.04|0.21|||Mixed Models Analysis|||||0.21|-0.04|0.166
71021365|NCT03118765|141550338|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.182|TWO_SIDED|95.0|-0.04|0.21|||Mixed Models Analysis|||||0.21|-0.04|0.182
71021366|NCT03118765|141550338|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.401|TWO_SIDED|95.0|-0.07|0.17|||Mixed Models Analysis|||||0.17|-0.07|0.401
71106522|NCT01405196|141719788|SUPERIORITY||LS mean difference|1.84|||||TWO_SIDED|90.0|-0.65|4.32||||||PCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.32|-0.65|
71106523|NCT01405196|141719788|SUPERIORITY||LS mean difference|2.01|||||TWO_SIDED|90.0|-0.47|4.5||||||PCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.50|-0.47|
71021367|NCT03118765|141550338|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.574|TWO_SIDED|95.0|-0.09|0.16|||Mixed Models Analysis|||||0.16|-0.09|0.574
71021368|NCT03118765|141550339|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.493|TWO_SIDED|95.0|-0.1|0.21|||Mixed Models Analysis|||||0.21|-0.10|0.493
71021369|NCT03118765|141550339|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.864|TWO_SIDED|95.0|-0.17|0.14|||Mixed Models Analysis|||||0.14|-0.17|0.864
71021370|NCT03118765|141550339|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.978|TWO_SIDED|95.0|-0.16|0.15|||Mixed Models Analysis|||||0.15|-0.16|0.978
71021371|NCT03118765|141550339|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.5|TWO_SIDED|95.0|-0.1|0.2|||Mixed Models Analysis|||||0.20|-0.10|0.500
71021372|NCT03118765|141550340|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.003|TWO_SIDED|95.0|0.04|0.2|||Mixed Models Analysis|||||0.20|0.04|0.003
71021373|NCT03118765|141550340|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.001|TWO_SIDED|95.0|0.06|0.22|||Mixed Models Analysis|||||0.22|0.06|0.001
71021374|NCT03118765|141550340|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.001|TWO_SIDED|95.0|0.06|0.21|||Mixed Models Analysis|||||0.21|0.06|0.001
71021375|NCT03118765|141550340|SUPERIORITY||Mean Difference (Final Values)|0.16|||<|0.001|TWO_SIDED|95.0|0.08|0.23|||Mixed Models Analysis|||||0.23|0.08|<0.001
71021376|NCT03118765|141550341|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.002|TWO_SIDED|95.0|0.06|0.24|||Mixed Models Analysis|||||0.24|0.06|0.002
71021377|NCT03118765|141550341|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.061|TWO_SIDED|95.0|0.0|0.18|||Mixed Models Analysis|||||0.18|-0.00|0.061
71021378|NCT03118765|141550341|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.14|TWO_SIDED|95.0|-0.02|0.16|||Mixed Models Analysis|||||0.16|-0.02|0.140
71021379|NCT03118765|141550341|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.002|TWO_SIDED|95.0|0.06|0.24|||Mixed Models Analysis|||||0.24|0.06|0.002
71021380|NCT00947518|141550347|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.99
71021381|NCT00947518|141550348|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANOVA|||||||0.46
71021382|NCT00947518|141550349|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
71021383|NCT00947518|141550350|SUPERIORITY||||||<|0.05|||||||Chi-squared||||For comparison of categorical variables among the three groups, Chi2 test followed by Bonferroni's correction was used.|||<0.05
71021384|NCT02766400|141550402|SUPERIORITY_OR_OTHER_LEGACY||Cohen's d effect size at 12 months|0.53|||<|0.001|TWO_SIDED|95.0|-0.12|1.19||a priori threshold was set at p\<0.05|Linear mixed models|F(4,150)=5.11|Effect size was calculated using mean change scores (baseline to month 12) and standard error of change (baseline to month 12) for each group.|All analyses were performed using the intent-to-treat principle so that comparisons were made according to the assigned intervention group regardless of study completion.||1.19|-0.12|<0.001
71106524|NCT01405196|141719788|SUPERIORITY||LS mean difference|2.34|||||TWO_SIDED|90.0|-0.15|4.82||||||PCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.82|-0.15|
71106525|NCT01405196|141719788|SUPERIORITY||LS mean difference|2.59|||||TWO_SIDED|90.0|0.11|5.08||||||PCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.08|0.11|
71106526|NCT01405196|141719790|SUPERIORITY||LS mean difference|2.08|||||TWO_SIDED|90.0|-1.26|5.42||||||Week 4: Analysis was done using the ANCOVA model; CI parameter being the Least Square (LS) mean difference from that model.||5.42|-1.26|
71106527|NCT01405196|141719790|SUPERIORITY||LS mean difference|1.95|||||TWO_SIDED|90.0|-1.38|5.29||||||Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.29|-1.38|
71106528|NCT01405196|141719790|SUPERIORITY||LS mean difference|2.81|||||TWO_SIDED|90.0|-0.53|6.15||||||Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||6.15|-0.53|
71021385|NCT00204932|141550403|NON_INFERIORITY_OR_EQUIVALENCE|Power analysis was based on test-retest variance of body fat mass measure by DEXA|||||<|0.05||95.0|||||ANOVA|||Analysis of variance to test CLA not equal to placebo||||<0.05
71021386|NCT00204932|141550403|SUPERIORITY||||||<|0.05|||||||ANOVA|||Pre- post treatment comparison o fat oxidation found that fat oxidation increased in CLA (4 +/- 8 g) and decreased in placebo (-7 +/- 11 g) groups during sleep. after 6 mo of supplementation.||||<0.05
71021387|NCT03593772|141550405|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.04819|STANDARD_ERROR_OF_MEAN|0.02482||0.0535|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total POQ Score as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.0535
71021388|NCT03593772|141550405|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00163|STANDARD_ERROR_OF_MEAN|0.001826||0.3729|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Pain Rating as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.3729
71021389|NCT03593772|141550405|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00593|STANDARD_ERROR_OF_MEAN|0.007228||0.4124|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Mobility as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.4124
71021390|NCT03593772|141550405|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00432|STANDARD_ERROR_OF_MEAN|0.009334||0.6442|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Activities of Daily Living as outcome variable. Linear mixed models were constructed with fixed effects terms for treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test if the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.6442
71021391|NCT03593772|141550405|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00898|STANDARD_ERROR_OF_MEAN|0.006436||0.1641|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Vitality as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.1641
71021392|NCT03593772|141550405|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.01952|STANDARD_ERROR_OF_MEAN|0.009846||0.0487|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Neg. Affect as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.0487
71021393|NCT03593772|141550405|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.0066|STANDARD_ERROR_OF_MEAN|0.004644||0.1554|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Fear as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.1554
71079543|NCT00482170|141666471|SUPERIORITY_OR_OTHER|||||||0.166||95.0|||||Chi-squared|||p-value for statistical difference between categories, very satisfied: alcohol usage- yes, very satisfied: alcohol usage- no, satisfied: alcohol usage- yes, satisfied: alcohol usage- no, less satisfied: alcohol usage- yes and less satisfied: alcohol usage- no, in the etanercept 50 mg prefilled syringe group was calculated.||||0.166
71079544|NCT00482170|141666472|SUPERIORITY_OR_OTHER|||||||0.535||95.0|||||Fisher Exact|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.535
71079545|NCT04333225|141666494|OTHER|Other: estimating risk reduction|Risk Ratio (RR)|2.0718||||0.0112|TWO_SIDED|95.0|1.15|3.72|||Chi-squared|||||3.72|1.15|0.0112
71079546|NCT04333225|141666495|OTHER|Other: Estimating hazard ratio|Hazard Ratio (HR)|0.35||||0.0105|TWO_SIDED|95.0|0.17|0.75|||Log Rank|||||0.75|0.17|0.0105
71079547|NCT00822328|141666512|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||Bacterial colonies were counted for study group and placebo group on week 0, 1, 2, 3, 4, 5, 6. Significant differences between both experimental groups at the same time were determined with one-way ANOVA (significance level p = 0.05).||||<0.05
70941639|NCT04748445|141383934|OTHER||Slope|0.01755|STANDARD_ERROR_OF_MEAN|7.204||0.0162|TWO_SIDED|90.0|0.005616|0.02949|||Mixed Models Analysis|||EE\_MFCC std 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.02949|0.005616|0.0162
71021394|NCT03593772|141550406|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00113|STANDARD_ERROR_OF_MEAN|0.000863||0.1924|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Pain as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1924
71021395|NCT03593772|141550406|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.0019|STANDARD_ERROR_OF_MEAN|0.001152||0.1002|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Stress as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1002
71021396|NCT03593772|141550406|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000343|STANDARD_ERROR_OF_MEAN|0.000996||0.7311|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Tension as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7311
71021397|NCT03593772|141550407|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00241|STANDARD_ERROR_OF_MEAN|0.001716||0.1622|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Pain as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1622
71021398|NCT03593772|141550407|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00235|STANDARD_ERROR_OF_MEAN|0.002052||0.254|TWO_SIDED||||||Mixed Models Analysis|||Analysis performed on Pain Interference with Activity as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.2540
71106529|NCT01405196|141719790|SUPERIORITY||LS mean difference|3.88|||||TWO_SIDED|90.0|0.54|7.22||||||Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||7.22|0.54|
71021399|NCT03593772|141550407|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00612|STANDARD_ERROR_OF_MEAN|0.002297||0.0082|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Pain Interference with Sleep as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0082
71021400|NCT03593772|141550407|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00636|STANDARD_ERROR_OF_MEAN|0.002378||0.0079|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Pain Interference with Mood as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0079
71021401|NCT03593772|141550407|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00334|STANDARD_ERROR_OF_MEAN|0.002367||0.1588|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Pain Interference with Stress as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1588
71106530|NCT01405196|141719790|SUPERIORITY||LS mean difference|1.95|||||TWO_SIDED|90.0|-1.39|5.29||||||Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.29|-1.39|
71106531|NCT01405196|141719790|SUPERIORITY||LS mean difference|1.69|||||TWO_SIDED|90.0|-1.65|5.03||||||Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.03|-1.65|
71106532|NCT01405196|141719790|SUPERIORITY||LS mean difference|1.69|||||TWO_SIDED|90.0|-1.61|4.99||||||Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.99|-1.61|
71106533|NCT01405196|141719790|SUPERIORITY||LS mean difference|0.97|||||TWO_SIDED|90.0|-2.31|4.26||||||Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.26|-2.31|
71106534|NCT01405196|141719790|SUPERIORITY||LS mean difference|1.33|||||TWO_SIDED|90.0|-1.96|4.61||||||Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.61|-1.96|
71106535|NCT01405196|141719790|SUPERIORITY||LS mean difference|3.6|||||TWO_SIDED|90.0|0.32|6.89||||||Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||6.89|0.32|
70932731|NCT02646618|141365481|NON_INFERIORITY|For secondary noninferiority outcomes, we used 90% power to calculate noninferiority margins given N=131 per arm, setting alpha=.05 and using observed SDs from the literature. For change in moderate to vigorous intensity physical activity minutes per day at 12 months, the noninferiority margin is 9.2 min/day(SD=25 min/day). However, we could not analyze the data in that manner and used the test described above.||||||0.4741|||||||Generalized estimating equation|||We examined the proportion of participants engaging in 150+ minutes/week of moderate/vigorous intensity physical activity (MVPA) using generalized estimating equations with a logit link function and incorporating repeated measures over time. For participants missing MVPA at either follow-up timepoint, we used a baseline observation carried forward approach to impute their activity level (150+ vs \<150 MVPA mins/week) at that timepoint.||||0.4741
70932732|NCT02397096|141365549|NON_INFERIORITY|Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) once daily (QD) ISG is concluded to be non-inferior to baseline regimen DSG if the lower bound of the 95% CI for the difference in percent response is above -8 percentage points.|Treatment Difference|-3.784|||||TWO_SIDED|95.0|-7.877|0.31|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.||Superiority of an immediate switch to DOR/3TC/TDF over continuation of the baseline regimen was defined by a lower bound of the two-sided 95% CI for the difference in response rates being greater than zero (contingent upon satisfying the multiplicity criteria).|0.310|-7.877|
70932733|NCT02397096|141365550|OTHER||Treatment Difference|-14.65|||<|0.0001|TWO_SIDED|95.0|-18.92|-10.38|||ANCOVA||95% CIs and 2-sided p-values were calculated from an ANCOVA model with terms for baseline lipid level, use of lipid-lowering therapy at Study Day 1 and treatment.|||-10.38|-18.92|<0.0001
70932734|NCT02397096|141365551|OTHER||Treatment Difference|-23.03|||<|0.0001|TWO_SIDED|95.0|-28.0|-18.05|||ANCOVA||95% CIs and 2-sided p-values were calculated from an ANCOVA model with terms for baseline lipid level, use of lipid-lowering therapy at Study Day 1 and treatment.|||-18.05|-28.00|<0.0001
70932735|NCT02397096|141365552|NON_INFERIORITY|DOR/3TC/TDF QD ISG is concluded to be non-inferior to baseline regimen DSG if the lower bound of the 95% CI for the difference in percent response is above -8 percentage points.|Treatment Difference|-0.877|||||TWO_SIDED|95.0|-4.706|2.952|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.||Superiority of an immediate switch to DOR/3TC/TDF over continuation of the baseline regimen was defined by a lower bound of the two-sided 95% CI for the difference in response rates being greater than zero (contingent upon satisfying the multiplicity criteria).|2.952|-4.706|
70932736|NCT02397096|141365553|OTHER||Mean Difference (Final Values)|-4.0|||||TWO_SIDED|95.0|-31.6|23.5|||||95% CIs were calculated based on t-distribution.|||23.5|-31.6|
71021402|NCT03593772|141550408|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00974|STANDARD_ERROR_OF_MEAN|0.01379||0.4808|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PCL-5 Total Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.4808
71021403|NCT03593772|141550409|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00033|STANDARD_ERROR_OF_MEAN|0.00856||0.9692|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Physical Health Domain Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.9692
70932737|NCT02397096|141365554|SUPERIORITY||Mean Difference (Final Values)|-12.8|||||TWO_SIDED|95.0|-41.1|15.4|||||95% Confidence Intervals were based on t-distribution.|||15.4|-41.1|
70932738|NCT02397096|141365555|OTHER||Treatment Difference|-3.556|||||TWO_SIDED|95.0|-7.977|0.864|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||0.864|-7.977|
71021404|NCT03593772|141550409|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.01738|STANDARD_ERROR_OF_MEAN|0.007848||0.0277|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Mental Health Domain Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0277
70932739|NCT02397096|141365556|OTHER||Treatment Difference|-0.427|||||TWO_SIDED|95.0|-4.591|3.738|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||3.738|-4.591|
70932740|NCT02397096|141365557|NON_INFERIORITY|DOR/3TC/TDF QD ISG is concluded to be non-inferior to baseline regimen DSG if the lower bound of the 95% CI for the difference in percent response is above -4 percentage points.|Treatment Difference|-0.232|||||TWO_SIDED|95.0|-2.529|2.064|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||2.064|-2.529|
70932741|NCT05580003|141365569|OTHER||Ratio of Adjusted Geometric Means|101.29|||||TWO_SIDED|90.0|95.71|107.18|||||A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.|AUCinf||107.18|95.71|
70932742|NCT05580003|141365569|OTHER||Ratio of Adjusted Geometric Means|102.74|||||TWO_SIDED|90.0|97.28|108.5|||||A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.|AUCinf||108.50|97.28|
71106536|NCT01405196|141719790|SUPERIORITY||LS mean difference|0.91|||||TWO_SIDED|90.0|-2.38|4.19||||||Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.19|-2.38|
71054087|NCT06017479|141612384|OTHER|"Chi-square test as the study used chi-square analysis to compare the incidence of UTIs between the groups (p = 0.660) For this non-inferiority analysis, the study demonstrated that the odds ratio (OR) between the two groups was 0.8 (95% CI: 0.4-1.95), indicating no significant difference. Further details are provided in the study's discussion section."|Odds Ratio (OR)|0.8|STANDARD_DEVIATION|18.125||0.66|TWO_SIDED|95.0|0.4|1.95||The p-value was not adjusted for multiple comparisons as there were no multiple outcome measures being compared in this analysis. The significance threshold (alpha) was set at 0.05.|Chi-squared||"The standard deviations (SD) for the groups are as follows:~For the group receiving 3g fosfomycin: 19.08 For the group receiving 500mg levofloxacin: 17.17"|This randomized controlled trial compared the incidence of UTI between two groups: patients receiving a single dose of 500 mg levofloxacin and patients receiving a single dose of 3 g fosfomycin one hour before a urodynamic study. The null hypothesis is that there is no significant difference in UTI incidence between the two groups. The power calculation was based on a sample size of 126 patients.|A chi-square test was performed to compare the incidence of UTIs between the two groups: patients receiving a single dose of 500 mg levofloxacin and those receiving a single dose of 3 g fosfomycin, both administered one hour before the urodynamic study (UDS). The result showed no statistically significant difference between the two groups (p = 0.660). An odds ratio was also calculated (OR = 0.8, 95% CI: 0.4-1.95), indicating a slightly lower likelihood of UTI in the fosfomycin group, but the difference was not significant.|1.95|0.4|0.660
71054088|NCT04058067|141612385|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|1.2||0.013|TWO_SIDED|95.0|-3.7|1.1|||ANOVA|||||1.1|-3.7|0.013
71054089|NCT04058067|141612386|SUPERIORITY||LS mean difference|-1.9|STANDARD_ERROR_OF_MEAN|1.15||0.035|TWO_SIDED|95.0|-4.2|0.4|||ANOVA|||||0.4|-4.2|0.035
71054090|NCT04058067|141612388|SUPERIORITY||Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|-3.0|0.8|||ANOVA|||||0.8|-3.0|
71054091|NCT04058067|141612389|SUPERIORITY||Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|95.0|-4.0|0.2|||ANOVA|||||0.2|-4.0|
71054092|NCT04058067|141612390|SUPERIORITY||Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|95.0|-4.3|0.2|||ANOVA|||||0.2|-4.3|
71054093|NCT04058067|141612393|SUPERIORITY||DIfference|-3.0|||||TWO_SIDED|95.0|-13.7|6.7|||Regression, Logistic|||Proportion of subjects with ≥5 letters gain from baseline or reached BCVA of ≥84 letters at Week 52||6.7|-13.7|
71054094|NCT04058067|141612393|SUPERIORITY||Difference|-2.6|||||TWO_SIDED|95.0|-14.7|9.4|||Regression, Logistic|||Proportion of subjects with ≥10 letters gain from baseline or reached BCVA of ≥84 letters at Week 52||9.4|-14.7|
71054095|NCT04058067|141612393|SUPERIORITY||Difference|-3.8|||||TWO_SIDED|95.0|-15.5|6.9|||Regression, Logistic|||Proportion of subjects with ≥15 letters gain from baseline or reached BCVA of ≥84 letters at Week 52||6.9|-15.5|
71054096|NCT04058067|141612397|SUPERIORITY||DIfference|0.1|||||TWO_SIDED|95.0|-4.2|4.4|||Regression, Logistic|||Proportion of subjects with ≥5 letters loss from baseline at Week 52||4.4|-4.2|
71054097|NCT04058067|141612397|SUPERIORITY||Difference|0.8|||||TWO_SIDED|95.0|-1.6|3.8|||Regression, Logistic|||Proportion of subjects with ≥10 letters loss from baseline at Week 52||3.8|-1.6|
71054098|NCT04058067|141612397|SUPERIORITY||Difference|0.0|||||TWO_SIDED|95.0|-2.2|2.3|||Regression, Logistic|||Proportion of subjects with ≥15 letters loss from baseline at Week 52||2.3|-2.2|
71054099|NCT04058067|141612398|OTHER|Descriptive, Week 4|Difference - %|0.4|||||TWO_SIDED|95.0|-7.9|8.6|||Clopper-Pearson exact method|||Week 4||8.6|-7.9|
71054100|NCT04058067|141612398|OTHER|Descriptive, Week 6|Difference - %|-5.1|||||TWO_SIDED|95.0|-14.3|2.9|||Clopper-Pearson exact method|||Week 6||2.9|-14.3|
71054101|NCT04058067|141612398|OTHER|Descriptive, Week 8|Difference - %|-4.0||||||95.0|-13.3|4.4|||Clopper-Pearson exact method|||Week 8||4.4|-13.3|
71054102|NCT04058067|141612398|OTHER|Descriptive, Week 12|Difference - %|-7.0|||||TWO_SIDED|95.0|-16.4|2.3|||Clopper-Pearson exact method|||Week 12||2.3|-16.4|
71054103|NCT04058067|141612398|OTHER|Descriptive, Week 16|Difference - %|-9.8|||||TWO_SIDED|95.0|-19.2|0.0|||Clopper-Pearson exact method|||Week 16||-0.0|-19.2|
71054104|NCT04058067|141612398|OTHER|Descriptive, Week 18|Difference - %|-9.8|||||TWO_SIDED|95.0|-19.0|0.0|||Clopper-Pearson exact method|||Week 18||-0.0|-19.0|
71054105|NCT04058067|141612398|OTHER|Descriptive, Week 20|Difference - %|-5.7|||||TWO_SIDED|95.0|-15.8|3.9|||Clopper-Pearson exact method|||Week 20||3.9|-15.8|
71054106|NCT04058067|141612398|OTHER|Descriptive, Week 24|Difference - %|-13.4|||||TWO_SIDED|95.0|-23.9|-3.1|||Clopper-Pearson exact method|||Week 24||-3.1|-23.9|
71054107|NCT04058067|141612398|OTHER|Descriptive, Week 28|Difference - %|-12.4|||||TWO_SIDED|95.0|-22.0|-2.1|||Clopper-Pearson exact method|||Week 28||-2.1|-22.0|
71054108|NCT04058067|141612398|OTHER|Descriptive, Week 32|Difference - %|-15.4|||||TWO_SIDED|95.0|-26.0|-4.8|||Clopper-Pearson exact method|||Week 32||-4.8|-26.0|
71021405|NCT03593772|141550410|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00188|STANDARD_ERROR_OF_MEAN|0.003253||0.5642|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total PSQI Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.5642
71021406|NCT03593772|141550410|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00092|STANDARD_ERROR_OF_MEAN|0.00079||0.2438|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Subjective Sleep Quality Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.2438
71021407|NCT03593772|141550410|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000304|STANDARD_ERROR_OF_MEAN|0.000885||0.7317|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Sleep latency Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7317
71021408|NCT03593772|141550410|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00062|STANDARD_ERROR_OF_MEAN|0.001327||0.6393|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Sleep duration Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.6393
71021409|NCT03593772|141550410|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00112|STANDARD_ERROR_OF_MEAN|0.000873||0.1995|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Sleep efficiency Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1995
71021410|NCT03593772|141550410|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00072|STANDARD_ERROR_OF_MEAN|0.000675||0.2886|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Sleep disturbance Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.2886
71021411|NCT03593772|141550410|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.002048|STANDARD_ERROR_OF_MEAN|0.001356||0.1323|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Use of sleep medication Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1323
71021412|NCT03593772|141550410|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000209|STANDARD_ERROR_OF_MEAN|0.000793||0.7923|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Daytime dysfunction Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7923
71021413|NCT03593772|141550411|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00046|STANDARD_ERROR_OF_MEAN|0.001074||0.6679|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on COS Total Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.6679
71054109|NCT04058067|141612398|OTHER|Descriptive, Week 36|Difference - %|-18.8|||||TWO_SIDED|95.0|-29.5|-8.9|||Clopper-Pearson exact method.|||Week 36||-8.9|-29.5|
71054110|NCT04058067|141612398|OTHER|Descriptive, Week 40|Difference - %|-18.4|||||TWO_SIDED|95.0|-28.7|-8.6|||Clopper-Pearson exact method|||Week 40||-8.6|-28.7|
71054111|NCT04058067|141612398|OTHER|Descriptive, Week 44|Difference - %|-14.9|||||TWO_SIDED|95.0|-25.6|-4.4|||Clopper-Pearson exact method|||Week 44||-4.4|-25.6|
71021414|NCT03593772|141550411|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001083|STANDARD_ERROR_OF_MEAN|0.000769||0.1607|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on COS Total Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1607
71021415|NCT03593772|141550411|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000984|STANDARD_ERROR_OF_MEAN|0.00064||0.126|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS- Total as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1260
70932743|NCT05580003|141365569|OTHER||Ratio of Adjusted Geometric Means|97.83|||||TWO_SIDED|90.0|91.32|104.8|||||A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.|AUClast||104.80|91.32|
71021416|NCT03593772|141550411|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000909|STANDARD_ERROR_OF_MEAN|0.000933||0.3311|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Self-Kindness Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.3311
70932744|NCT05580003|141365569|OTHER||Ratio of Adjusted Geometric Means|102.41|||||TWO_SIDED|90.0|95.6|109.7|||||A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.|AUClast||109.70|95.60|
70932745|NCT05580003|141365570|OTHER||Ratio of Adjusted Geometric Means|67.18|||||TWO_SIDED|90.0|58.13|77.65|||||A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.|||77.65|58.13|
71021417|NCT03593772|141550411|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001041|STANDARD_ERROR_OF_MEAN|0.000887||0.2416|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Self-Judgment Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.2416
71021418|NCT03593772|141550411|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00087|STANDARD_ERROR_OF_MEAN|0.001016||0.3903|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Common Humanity Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.3903
71021419|NCT03593772|141550411|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001186|STANDARD_ERROR_OF_MEAN|0.00095||0.2131|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Isolation Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.2131
71054112|NCT04058067|141612398|OTHER|Descriptive, Week 48|Difference - %|-13.3|||||TWO_SIDED|95.0|-23.6|-3.4|||Clopper-Pearson exact method|||Week 48||-3.4|-23.6|
71054113|NCT04058067|141612398|OTHER|Descriptive, Week 52|Difference - %|-12.6|||||TWO_SIDED|95.0|-23.5|-2.9|||Clopper-Pearson exact method|||Week 52||-2.9|-23.5|
71054114|NCT04058067|141612399|SUPERIORITY||Difference|-1.3|||||TWO_SIDED|95.0|-13.6|11.2|||Clopper-Pearson exact method|||||11.2|-13.6|
71054115|NCT04058067|141612401|SUPERIORITY||Difference|-10.2|STANDARD_ERROR_OF_MEAN|13.79|||TWO_SIDED|95.0|-37.3|17.0|||ANOVA|||||17.0|-37.3|
71054116|NCT04058067|141612402|SUPERIORITY||Difference|-2.5|STANDARD_ERROR_OF_MEAN|12.34|||TWO_SIDED|95.0|-26.8|21.9|||ANOVA|||||21.9|-26.8|
71054117|NCT04058067|141612403|SUPERIORITY||Difference|-8.5|STANDARD_ERROR_OF_MEAN|11.03|||TWO_SIDED|95.0|-30.3|13.2|||ANOVA|||||13.2|-30.3|
71054118|NCT04058067|141612404|SUPERIORITY||Difference - %|5.3|||||TWO_SIDED|95.0|-3.3|13.5|||Clopper-Pearson exact method|||Week 4||13.5|-3.3|
71054119|NCT04058067|141612404|SUPERIORITY||Difference - %|10.8|||||TWO_SIDED|95.0|1.4|20.6|||Clopper-Pearson exact method|||Week 6||20.6|1.4|
71054120|NCT04058067|141612404|SUPERIORITY||Difference - %|14.1|||||TWO_SIDED|95.0|3.9|25.3|||Clopper-Pearson exact method|||Week 8||25.3|3.9|
71054121|NCT04058067|141612404|SUPERIORITY||Difference - %|14.1|||||TWO_SIDED|95.0|2.8|24.9|||Clopper-Pearson exact method||Proportion estimates (%) = 39.3|Week 12||24.9|2.8|
71054122|NCT04058067|141612404|SUPERIORITY||Difference - %|16.8||||||95.0|5.1|28.6|||Clopper-Pearson exact method|||Week 16||28.6|5.1|
71054123|NCT04058067|141612404|SUPERIORITY||Difference - %|15.4|||||TWO_SIDED|95.0|3.1|26.6|||Clopper-Pearson exact method|||Week 18||26.6|3.1|
70932746|NCT05580003|141365570|OTHER||Ratio of Adjusted Geometric Means|74.12|||||TWO_SIDED|90.0|64.14|85.67|||||A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.|||85.67|64.14|
70932747|NCT05580003|141365606|OTHER||Ratio of Adjusted Geometric Means|72.87|||||TWO_SIDED|90.0|60.98|87.09|||||A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages|AUCinf||87.09|60.98|
70932748|NCT05580003|141365606|OTHER||Ratio of Adjusted Geometric Means|76.45|||||TWO_SIDED|90.0|68.35|85.52|||||A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages|AUCinf||85.52|68.35|
71021420|NCT03593772|141550411|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001485|STANDARD_ERROR_OF_MEAN|0.000933||0.113|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Mindfulness Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1130
71021421|NCT03593772|141550411|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001983|STANDARD_ERROR_OF_MEAN|0.000939||0.0358|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Over-identification Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0358
71021422|NCT03593772|141550411|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00019|STANDARD_ERROR_OF_MEAN|0.000495||0.7027|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS- Total Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7027
71021423|NCT03593772|141550411|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000761|STANDARD_ERROR_OF_MEAN|0.00073||0.2979|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Self-Kindness Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.2979
71021424|NCT03593772|141550411|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00063|STANDARD_ERROR_OF_MEAN|0.000798||0.4278|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Self-Judgment Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.4278
71054124|NCT04058067|141612404|SUPERIORITY||Difference - %|15.7|||||TWO_SIDED|95.0|3.5|27.1|||Clopper-Pearson exact method|||Week 20||27.1|3.5|
71054125|NCT04058067|141612404|SUPERIORITY||Difference - %|19.1|||||TWO_SIDED|95.0|7.2|30.2|||Clopper-Pearson exact method|||Week 24||30.2|7.2|
71054126|NCT04058067|141612404|SUPERIORITY||Difference - %|16.4|||||TWO_SIDED|95.0|4.9|27.9|||Clopper-Pearson exact method|||Week 28||27.9|4.9|
70932749|NCT05580003|141365606|OTHER||Ratio of Adjusted Geometric Means|73.52|||||TWO_SIDED|90.0|65.7|82.27|||||A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages|AUClast||82.27|65.70|
70932750|NCT05580003|141365606|OTHER||Ratio of Adjusted Geometric Means|75.16|||||TWO_SIDED|90.0|66.36|85.13|||||A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages|AUClast||85.13|66.36|
71054127|NCT04058067|141612404|SUPERIORITY||Difference - %|12.1|||||TWO_SIDED|95.0|0.4|24.4|||Clopper-Pearson exact method|||Week 32||24.4|0.4|
71054128|NCT04058067|141612404|SUPERIORITY||Difference - %|6.0|||||TWO_SIDED|95.0|-5.9|18.0|||Clopper-Pearson exact method|||Week 36||18.0|-5.9|
71054129|NCT04058067|141612404|SUPERIORITY||Difference - %|15.2|||||TWO_SIDED|95.0|3.3|26.1|||Clopper-Pearson exact method|||Week 40||26.1|3.3|
71054130|NCT04058067|141612404|SUPERIORITY||Difference - %|13.2|||||TWO_SIDED|95.0|1.9|25.7|||Clopper-Pearson exact method|||Week 44||25.7|1.9|
71054131|NCT04058067|141612404|SUPERIORITY||Difference - %|11.9|||||TWO_SIDED|95.0|-0.8|23.6|||Clopper-Pearson exact method|||Week 48||23.6|-0.8|
71054132|NCT04058067|141612404|SUPERIORITY||Difference - %|17.9|||||TWO_SIDED|95.0|5.8|30.5|||Clopper-Pearson exact method|||Week 52||30.5|5.8|
71054133|NCT04058067|141612405|SUPERIORITY||Difference|0.9|||||TWO_SIDED|95.0|0.8|3.6|||Clopper-Pearson exact method|||||3.6|0.8|
71054134|NCT04058067|141612406|SUPERIORITY||Difference|-4.3|||||TWO_SIDED|95.0|-13.2|4.6|||Clopper-Pearson exact method|||||4.6|-13.2|
71054135|NCT04058067|141612407|SUPERIORITY||Difference|1.0|||||TWO_SIDED|95.0|-10.5|12.4|||Clopper-Pearson exact method|||||12.4|-10.5|
71106537|NCT01405196|141719790|SUPERIORITY||LS mean difference|0.6|||||TWO_SIDED|90.0|-2.68|3.88||||||Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.88|-2.68|
71106538|NCT01729039|141719791|SUPERIORITY|||||||0.356||||||Main effect of time (baseline to post-PT) alpha = .05|ANOVA|||||||.356
71106539|NCT01729039|141719791|SUPERIORITY|||||||0.84||||||Interaction of Time by Group (GS vs. CON) alpha = .05|ANOVA|||||||.840
71106540|NCT01729039|141719792|SUPERIORITY|||||||0.17||||||Main effect of Time (baseline to post-PT) Alpha=.05|ANOVA|||||||.170
71106541|NCT01729039|141719792|SUPERIORITY|||||||0.297||||||Interaction of Time by Group (GS vs. CON) alpha = .05|ANOVA|||||||.297
71106542|NCT01729039|141719793|SUPERIORITY||||||<|0.001|||||||ANOVA|Main effect of Time (baseline to post-PT) alpha = .05||||||<.001
71106543|NCT01729039|141719793|SUPERIORITY|||||||0.817||||||Interaction of Time by Group (GS vs. CON) alpha = .05|ANOVA|||||||.817
70932751|NCT05580003|141365607|OTHER||Ratio of Adjusted Geometric Means|76.72|||||TWO_SIDED|90.0|60.21|97.75|||||A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages|||97.75|60.21|
71106544|NCT01729039|141719794|SUPERIORITY|||||||0.005||||||Main effect of Time (baseline to post-PT) alpha = .05|ANOVA|||||||.005
71106545|NCT01729039|141719794|SUPERIORITY|||||||0.172||||||Interaction of Time by Group (GS vs. CON) alpha = .05|ANOVA|||||||.172
71106546|NCT01729039|141719795|SUPERIORITY|||||||0.009||||||Main effect of time (baseline to post-PT) alpha = .05|ANOVA|||||||.009
71106547|NCT01729039|141719795|SUPERIORITY|||||||0.146||||||Interaction of Time by Grou (GS vs. CON) alpha = .05|ANOVA|||||||.146
71106548|NCT01585025|141719814|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||Paired comparison of fasting FGF19 at baseline on day 0 and on day 14 of OCA treatment||||0.007
71106549|NCT01585025|141719814|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Paired comparison of fasting FGF19 at baseline on day 0 and on day 14 of OCA treatment||||0.11
71106550|NCT01585025|141719814|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Paired comparison of fasting FGF19 at baseline on day 0 and on day 14 of OCA treatment||||0.12
71106551|NCT01585025|141719815|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Change in FGF19 AUC||||0.72
71106552|NCT01585025|141719815|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Change in FGF19 AUC||||0.51
71106553|NCT01585025|141719815|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Change in FGF19 AUC||||0.13
71106554|NCT01585025|141719816|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Change in fasting C4||||0.03
71106555|NCT01585025|141719816|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Change in fasting C4||||0.11
71106556|NCT01585025|141719816|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Change in fasting C4||||0.02
71106557|NCT01585025|141719817|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Change in bile acid 6h AUC||||0.02
71106558|NCT01585025|141719817|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Change in bile acid 6h AUC||||0.04
71106559|NCT01585025|141719817|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Change in bile acid 6h AUC||||0.02
71106560|NCT01585025|141719818|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in number of stools per week||||0.03
71106561|NCT01585025|141719818|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in number of stools per week||||0.17
71106562|NCT01585025|141719818|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in number of stools per week||||0.31
71106563|NCT01585025|141719819|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Change in median stool form||||0.05
71106564|NCT01585025|141719819|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Change in median stool form||||0.04
71106565|NCT01585025|141719819|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Change in median stool form||||0.74
71106566|NCT01585025|141719820|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||Paired difference in weekly index score||||0.005
71106567|NCT01585025|141719820|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Paired difference in weekly index score||||0.03
71106568|NCT01585025|141719820|SUPERIORITY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||Paired difference in weekly index score||||0.61
71106569|NCT00582907|141719821|SUPERIORITY_OR_OTHER||Risk Ratio, log|-1.7|STANDARD_DEVIATION|0.78||0.027|TWO_SIDED|95.0|-3.4|-0.1|||Signed rank|||Based upon FMF colchicine controlled studies showing an \~80% decrease in attacks, we estimated, based on baseline attacks every 4 weeks, there would be a difference of 0.5 attacks per month between rilonacept and placebo. With a two-sided 5% significance level and power of 80% we aimed for 14 evaluable participants who completed at least 2 treatment courses. The null hypothesis is that there would be no significant differences in the number of attacks between use of rilonacept and placebo.||-0.1|-3.4|0.027
71106570|NCT00582907|141719821|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59|STANDARD_DEVIATION|0.12||||95.0|0.39|0.85|||Bayesian modeling||Attacks while receiving rilonacept is the numerator and attacks while receiving placebo is the denominator. In Bayesian statistics credible interval equals confidence interval.|This analysis was done by Bayesian Statistics using a non-informative (neutral) prior (log normal distribution mean 9 \[SD 10\]). The null hypothesis was that the rilonacept/placebo FMF odds ratio of attacks was 1.||0.85|0.39|
71106571|NCT00582907|141719822|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0|STANDARD_DEVIATION|1.26||0.047|TWO_SIDED|95.0|-4.0|0.0|||Signed rank|||Null hypothesis: There were no significant differences between rilonacept and placebo in the occurence of injection site reactions. No power calculations for this outcome.||0|-4|0.047
71106572|NCT00582907|141719822|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.13|TWO_SIDED|95.0|-0.56|0.17|||Signed rank|||Null hypothesis: There were no significant differences between rilonacept and placebo in the occurence of infections. No power calculations for this outcome.||0.17|-0.56|0.13
71106573|NCT00582907|141719823|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2|STANDARD_DEVIATION|0.5||0.32||95.0|-2.4|0.5|||Signed rank|||Null hypothesis: There were no significant differences in the length of attacks during rilonacept vs. placebo treatment courses. Since this was a secondary outcome there were no power calculations performed.||0.5|-2.4|0.32
71106574|NCT00582907|141719824|SUPERIORITY_OR_OTHER||Differences in percent of courses|29.0||||0.004||95.0|||||McNemar|||Null hypothesis: There are no significant differences in the number of treatment courses without attacks between rilonacept and placebo. As a secondary measure there were no power calculations.||||0.004
71021425|NCT03593772|141550411|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.0000074|STANDARD_ERROR_OF_MEAN|0.000877||0.9933|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Common Humanity Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.9933
70932752|NCT05580003|141365607|OTHER||Ratio of Adjusted Geometric Means|70.92|||||TWO_SIDED|90.0|53.7|93.67|||||A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages|||93.67|53.70|
71021426|NCT03593772|141550411|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00115|STANDARD_ERROR_OF_MEAN|0.000816||0.1589|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Isolation Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1589
71021427|NCT03593772|141550411|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000109|STANDARD_ERROR_OF_MEAN|0.000767||0.8875|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Mindfulness Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.8875
71021428|NCT03593772|141550411|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00032|STANDARD_ERROR_OF_MEAN|0.00078||0.6859|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Over-identification Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.6859
71021429|NCT03593772|141550412|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.01408|STANDARD_ERROR_OF_MEAN|0.01085||0.1959|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on BDI total score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1959
71021430|NCT03593772|141550413|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00788|STANDARD_ERROR_OF_MEAN|0.005845||0.1792|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Perceived Stress Scale Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1792
71021431|NCT03593772|141550414|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.00132|STANDARD_ERROR_OF_MEAN|0.01039||0.8991|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total RDAS as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.8991
71021432|NCT03593772|141550414|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.002105|STANDARD_ERROR_OF_MEAN|0.002349||0.3711|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Decision Making Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.3711
71054136|NCT04058067|141612412|OTHER|Descriptive, Week 28|Difference - %|-2.4|||||TWO_SIDED|95.0|-13.9|8.8|||Clopper-Pearson exact method|||Week 28||8.8|-13.9|
71054137|NCT04058067|141612412|OTHER|Descriptive, Week 52|Difference - %|-2.8|||||TWO_SIDED|95.0|-14.1|9.0|||Clopper-Pearson exact method|||Week 52||9.0|-14.1|
71054138|NCT04058067|141612414|OTHER|Descriptive, Week 28|Difference - %|4.2|||||TWO_SIDED|95.0|-4.1|12.6|||Clopper-Pearson exact method|||Week 28||12.6|-4.1|
71054139|NCT04058067|141612414|OTHER|Descriptive, Week 52|Difference - %|-0.5|||||TWO_SIDED|95.0|-10.5|9.3|||Clopper-Pearson exact method|||Week 52||9.3|-10.5|
71054140|NCT04058067|141612416|OTHER|Descriptive, Week 28|Difference - %|0.8|||||TWO_SIDED|95.0|0.7|2.9|||Clopper-Pearson exact method|||Week 28||2.9|0.7|
70932753|NCT03333109|141365669|SUPERIORITY||Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|0.34||0.002|TWO_SIDED|95.0|-1.77|-0.42|||Mixed Models Analysis|||||-0.42|-1.77|0.002
70932754|NCT03333109|141365669|SUPERIORITY||Median Difference (Final Values)|-1.69|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-2.45|-0.93|||Mixed Models Analysis|||||-0.93|-2.45|<0.001
70932755|NCT03333109|141365670|SUPERIORITY||Odds Ratio (OR)|1.52||||0.007|TWO_SIDED|95.0|1.12|2.07|||Cochran-Mantel-Haenszel|Haenszel (CMH) test adjusted for stratification factor after missing data were imputed as non-response (NRI).||||2.07|1.12|0.007
70932756|NCT03333109|141365670|SUPERIORITY||Odds Ratio (OR)|2.21|||<|0.001|TWO_SIDED|95.0|1.55|3.15|||Cochran-Mantel-Haenszel|Haenszel (CMH) test adjusted for stratification factor after missing data were imputed as non-response (NRI).||||3.15|1.55|<0.001
70932757|NCT03333109|141365671|SUPERIORITY||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-2.07|-0.64|||Mixed Models Analysis|||||-0.64|-2.07|<0.001
70932758|NCT03333109|141365671|SUPERIORITY||Mean Difference (Net)|-1.9|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-2.71|-1.09|||Mixed Models Analysis|||||-1.09|-2.71|<0.001
70932759|NCT03333109|141365672|SUPERIORITY||Mean Difference (Final Values)|-1.77|STANDARD_ERROR_OF_MEAN|0.62||0.004|TWO_SIDED|95.0|-2.99|-0.56|||Mixed Models Analysis|||||-0.56|-2.99|0.004
71021433|NCT03593772|141550414|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001864|STANDARD_ERROR_OF_MEAN|0.002348||0.428|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Values Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.4280
71021434|NCT03593772|141550414|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00007|STANDARD_ERROR_OF_MEAN|0.003205||0.9831|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Affection Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.9831
71021435|NCT03593772|141550414|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.003052|STANDARD_ERROR_OF_MEAN|0.006364||0.632|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total Consensus Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.6320
71021436|NCT03593772|141550414|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.00007|STANDARD_ERROR_OF_MEAN|0.002259||0.9755|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Stability Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.9755
71054141|NCT04058067|141612418|OTHER|Descriptive, Week 28|Difference - %|0.8|||||TWO_SIDED|95.0|0.7|2.9|||Clopper-Pearson exact method|||Week 28||2.9|0.7|
70932760|NCT03333109|141365672|SUPERIORITY||Mean Difference (Final Values)|-2.71|STANDARD_ERROR_OF_MEAN|0.69|<|0.001|TWO_SIDED|95.0|-4.07|-1.36|||Mixed Models Analysis|||||-1.36|-4.07|<0.001
70932761|NCT01447706|141365693|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.37||||0.007|TWO_SIDED|95.0|0.18|0.76|||Log Rank|||||0.76|0.18|0.007
71054142|NCT04058067|141612419|SUPERIORITY||LS mean difference|-0.9||||||95.0|-4.1|2.3|||ANCOVA|||Week 28||2.3|-4.1|
70932762|NCT01447706|141365693|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.8||||0.023|TWO_SIDED|95.0|1.08|2.98|||Log Rank|||||2.98|1.08|0.023
70932763|NCT00918203|141365694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.2133|TWO_SIDED|95.0|0.86|1.93|||Log Rank|||||1.93|0.86|0.2133
70932764|NCT00918203|141365697|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.8731|TWO_SIDED|95.0|0.68|1.57|||Log Rank|||||1.57|0.68|0.8731
70932765|NCT00918203|141365698|SUPERIORITY_OR_OTHER|||||||0.4721|||||||Fisher Exact|||||||0.4721
70932766|NCT05485805|141365785|OTHER||Geometric LS means|-5.95|||=|0.004|TWO_SIDED|95.0|-9.946|-1.954|||ANCOVA|||||-1.954|-9.946|= 0.004
70932767|NCT05485805|141365785|OTHER||Geometric LS means|6.161|||=|0.003|TWO_SIDED|95.0|2.161|10.161|||ANCOVA|||||10.161|2.161|= 0.003
70932768|NCT05485805|141365785|OTHER||Geometric LS means|25.936|||<|0.001|TWO_SIDED|95.0|20.317|31.556|||ANCOVA|||||31.556|20.317|< 0.001
70932769|NCT05485805|141365785|OTHER||Geometric LS means|-3.476|||=|0.325|TWO_SIDED|95.0|-10.41|3.457|||ANCOVA|||||3.457|-10.41|= 0.325
70932770|NCT05485805|141365785|OTHER||Geometric LS means|0.211|||=|0.918|TWO_SIDED|95.0|-3.798|4.22|||ANCOVA|||||4.22|-3.798|= 0.918
70932771|NCT05485805|141365785|OTHER||Geometric LS means|32.097|||<|0.001|TWO_SIDED|95.0|26.484|37.71|||ANCOVA|||||37.71|26.484|< 0.001
70932772|NCT05485805|141365785|OTHER||Geometric LS means|22.46|||<|0.001|TWO_SIDED|95.0|16.753|28.166|||ANCOVA|||||28.166|16.753|< 0.001
70932773|NCT05485805|141365785|OTHER||Geometric LS means|26.147|||<|0.001|TWO_SIDED|95.0|20.529|31.765|||ANCOVA|||||31.765|20.529|< 0.001
70932774|NCT05485805|141365785|OTHER||Geometric LS means|28.62|||<|0.001|TWO_SIDED|95.0|22.921|34.32|||ANCOVA|||||34.32|22.921|< 0.001
70932775|NCT05485805|141365785|OTHER||Geometric LS means|22.671|||<|0.001|TWO_SIDED|95.0|16.966|28.375|||ANCOVA|||||28.375|16.966|< 0.001
70932776|NCT05485805|141365786|OTHER||Geometric LS means|-1.602|||<|0.001|TWO_SIDED|95.0|-2.548|-0.656|||ANCOVA|||0-2 hours post-dose||-0.656|-2.548|< 0.001
70932777|NCT05485805|141365786|OTHER||Geometric LS means|0.976|||=|0.043|TWO_SIDED|95.0|0.029|1.923|||ANCOVA|||0-2 hours post-dose||1.923|0.029|= 0.043
70932778|NCT05485805|141365786|OTHER||Geometric LS means|6.097|||<|0.001|TWO_SIDED|95.0|4.766|7.427|||ANCOVA|||0-2 hours post-dose||7.427|4.766|< 0.001
70932779|NCT05485805|141365786|OTHER||Geometric LS means|0.31|||=|0.711|TWO_SIDED|95.0|-1.332|1.951|||ANCOVA|||0-2 hours post-dose||1.951|-1.332|= 0.711
71021437|NCT03593772|141550414|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.00056|STANDARD_ERROR_OF_MEAN|0.001818||0.7584|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Conflict Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7584
71021438|NCT03593772|141550414|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000297|STANDARD_ERROR_OF_MEAN|0.003444||0.9313|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total Satisfaction Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.9313
71021439|NCT03593772|141550414|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00129|STANDARD_ERROR_OF_MEAN|0.002097||0.5401|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Activities Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.5401
71021440|NCT03593772|141550414|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.00018|STANDARD_ERROR_OF_MEAN|0.002471||0.9421|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Discussion Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.9421
71021441|NCT03593772|141550414|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00151|STANDARD_ERROR_OF_MEAN|0.003983||0.7042|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total Cohesion Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7042
71021442|NCT03593772|141550414|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.02128|STANDARD_ERROR_OF_MEAN|0.008331||0.0114|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total RDAS Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0114
71021443|NCT03593772|141550414|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.002587|STANDARD_ERROR_OF_MEAN|0.001727||0.1358|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Decision Making Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1358
70851347|NCT00669409|141190547|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-14.9|16.3||||||Change at Week 2, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.3|-14.9|
71021444|NCT03593772|141550414|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001402|STANDARD_ERROR_OF_MEAN|0.001796||0.4354|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Values Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.4354
71021445|NCT03593772|141550414|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.005759|STANDARD_ERROR_OF_MEAN|0.002113||0.007|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on AffectionSubdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0070
71054143|NCT04058067|141612419|SUPERIORITY||LS mean difference|0.1|||||TWO_SIDED|95.0|-3.1|3.3|||ANCOVA|||Week 52||3.3|-3.1|
71054144|NCT05005312|141612446|OTHER|The ratio and 90% CI were expressed as percentages|Ratio of Adjusted Geometric Means|101.96|||||TWO_SIDED|90.0|74.2|140.11|||ANOVA|||||140.11|74.20|
70932780|NCT05485805|141365786|OTHER||Geometric LS means|-0.626|||=|0.196|TWO_SIDED|95.0|-1.575|0.323|||ANCOVA|||0-2 hours post-dose||0.323|-1.575|= 0.196
71054145|NCT05005312|141612447|OTHER|The ratio and 90% CI were expressed as percentages|Ratio of Adjusted Geometric Means|99.29|||||TWO_SIDED|90.0|70.81|139.21|||ANOVA|||||139.21|70.81|
71054146|NCT05005312|141612448|OTHER|The ratio and 90% CI were expressed as percentages|Ratio of Adjusted Geometric Means|98.78|||||TWO_SIDED|90.0|70.65|138.12|||ANOVA|||||138.12|70.65|
71054147|NCT02704403|141612459|SUPERIORITY||Mean Difference (Net)|0.043||||0.0659|TWO_SIDED|95.0|-0.003|0.09|||Regression, Logistic|test is 2-sided, alpha=0.01||The null hypothesis was that there was no difference in response rates between the elafibranor and placebo treatment groups. The alternative hypothesis was that there was a difference in the response rates between the elafibranor and placebo treatment groups.||0.090|-0.003|0.0659
71054148|NCT02704403|141612460|SUPERIORITY||Cox Proportional Hazard|0.95|||||TWO_SIDED|95.0|0.619|1.457|||||No formal test due to the early termination of the study.|||1.457|0.619|
71106575|NCT00582907|141719825|SUPERIORITY_OR_OTHER||Difference in percent of courses|40.0||||0.006||95.0|||||McNemar|||Null hypothesis: There are no significant differences in the number of treatment courses attaining at least a 50% decrease in attacks when compared to baseline between rilonacept and placebo courses.Since this was a secondary measure there were no power calculations.||||0.006
71106576|NCT00582907|141719826|SUPERIORITY_OR_OTHER||Log Rank|0.009||||0.009||95.0|||||Kaplan-Meier survival analysis|||Null hypothesis: There were no significant differences between rilonacept and placebo in the number of days from the start of the treatment course until the development of the a second attack.||||0.009
71106577|NCT00582907|141719827|SUPERIORITY_OR_OTHER||Median Difference (Net)|6.5||||0.156|TWO_SIDED|95.0|-0.5|12.5|||Signed Rank|||Null hypothesis: There are no significant differences in the erythrocyte sedimentation rate between rilonacept and placebo. As a secondary measure there were no power calculations.||12.5|-0.5|0.156
71106578|NCT00582907|141719828|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.04||||0.22|TWO_SIDED|95.0|-0.03|0.29|||Signed Rank|||Null hypothesis: There are no differences in the C-reactive protein levels between the treatment courses. Since this was a secondary outcome measure no power calculations were performed.||0.29|-0.03|0.22
71106579|NCT00582907|141719829|SUPERIORITY_OR_OTHER||Median Difference (Net)|29.4||||0.078|TWO_SIDED|95.0|0.4|78.1|||Signed Rank|||Null hypothesis: There were no differences between the platelet count between the rilonacept and placebo courses. Since this was a secondary outcome no power calculations were performed.||78.1|0.4|0.078
70932781|NCT05485805|141365786|OTHER||Geometric LS means|7.073|||<|0.001|TWO_SIDED|95.0|5.744|8.402|||ANCOVA|||0-2 hours post-dose||8.402|5.744|< 0.001
71054149|NCT00176423|141612479|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71054150|NCT00176423|141612480|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
71054151|NCT00176423|141612481|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
71054152|NCT00176423|141612482|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
71054153|NCT05502081|141612483|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054154|NCT05502081|141612483|SUPERIORITY|||||||0.176|||||||Kruskal-Wallis|||||||0.176
71054155|NCT05502081|141612483|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054156|NCT05502081|141612483|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054157|NCT05502081|141612484|SUPERIORITY|||||||0.011|||||||Kruskal-Wallis|||||||0.011
71054158|NCT05502081|141612484|SUPERIORITY|||||||0.021|||||||Kruskal-Wallis|||||||0.021
71054159|NCT05502081|141612484|SUPERIORITY|||||||0.42|||||||Kruskal-Wallis|||||||0.42
71054160|NCT05502081|141612484|SUPERIORITY|||||||0.007|||||||Kruskal-Wallis|||||||0.007
71054161|NCT05502081|141612485|SUPERIORITY|||||||0.99|||||||Kruskal-Wallis|||||||0.99
71054162|NCT05502081|141612486|SUPERIORITY|||||||0.005|||||||Kruskal-Wallis|||||||0.005
71054163|NCT05502081|141612486|SUPERIORITY|||||||0.99|||||||Kruskal-Wallis|||||||0.99
71054164|NCT05502081|141612486|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
71054165|NCT05502081|141612486|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
71054166|NCT05502081|141612487|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054167|NCT05502081|141612487|SUPERIORITY|||||||0.119|||||||Kruskal-Wallis|||||||0.119
71054168|NCT05502081|141612487|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054169|NCT05502081|141612487|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054170|NCT05502081|141612488|SUPERIORITY|||||||0.933|||||||Kruskal-Wallis|||||||0.933
71054171|NCT05502081|141612489|SUPERIORITY|||||||0.011|||||||Kruskal-Wallis|||||||0.011
71106580|NCT00582907|141719830|SUPERIORITY_OR_OTHER||Median Difference (Net)|108.0||||0.063|TWO_SIDED|95.0|6.5|139.5|||Signed Rank|||Null hypothesis: There are no differences between the treatment arms in the fibrinogen level. Since this was a secondary outcome no power calculations were performed.||139.5|6.5|0.063
70932782|NCT05485805|141365786|OTHER||Geometric LS means|6.406|||<|0.001|TWO_SIDED|95.0|5.055|7.757|||ANCOVA|||0-2 hours post-dose||7.757|5.055|< 0.001
71054172|NCT05502081|141612489|SUPERIORITY|||||||0.054|||||||Kruskal-Wallis|||||||0.054
71054173|NCT05502081|141612489|SUPERIORITY|||||||0.185|||||||Kruskal-Wallis|||||||0.185
71054174|NCT05502081|141612489|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
71054175|NCT05502081|141612490|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054176|NCT05502081|141612490|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
71054177|NCT05502081|141612490|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054178|NCT05502081|141612490|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054179|NCT05502081|141612491|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054180|NCT05502081|141612491|SUPERIORITY|||||||0.758|||||||Kruskal-Wallis|||||||0.758
71054181|NCT05502081|141612491|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054182|NCT05502081|141612491|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054183|NCT05502081|141612492|SUPERIORITY|||||||0.412|||||||Kruskal-Wallis|||||||0.412
71054184|NCT05502081|141612493|SUPERIORITY|||||||0.106|||||||Kruskal-Wallis|||||||0.106
71054185|NCT05502081|141612494|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||||||0.01
71021446|NCT03593772|141550414|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.01037|STANDARD_ERROR_OF_MEAN|0.004485||0.0217|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total Consensus Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0217
71021447|NCT03593772|141550414|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00039|STANDARD_ERROR_OF_MEAN|0.001461||0.7881|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Stability Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7881
71021448|NCT03593772|141550414|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.004717|STANDARD_ERROR_OF_MEAN|0.00141||0.001|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Conflict Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0010
71021449|NCT03593772|141550414|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.004393|STANDARD_ERROR_OF_MEAN|0.002415||0.0693|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total Satisfaction Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0693
71021450|NCT03593772|141550414|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.002959|STANDARD_ERROR_OF_MEAN|0.001887||0.1184|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Activities Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1184
71021451|NCT03593772|141550414|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.003436|STANDARD_ERROR_OF_MEAN|0.002262||0.1301|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Discussion Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1301
71021452|NCT03593772|141550414|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.006022|STANDARD_ERROR_OF_MEAN|0.003697||0.1049|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total Cohesion Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1049
71021453|NCT01989195|141550421|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
71021454|NCT02731833|141550433|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.505|-0.3|||ANCOVA|Change from baseline in Schiff Sensitivity Score as response, treatment as factor and baseline Schiff sensitivity score as a covariate.|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|Statistical analyses was conducted under the null hypothesis (H0) of no difference between treatments versus the alternate hypothesis (H1) of a difference between treatments.||-0.300|-0.505|<0.0001
71021455|NCT02795780|141550477|OTHER|||||||0.0166||||||No adjustments for multiplicity. No a priori threshold defined.|ANCOVA|Adjusted for baseline SUVr, age, and diagnosis group (AD/MCI)||Test of whether difference in least squares mean change is 0||||0.0166
71021456|NCT02795780|141550477|OTHER|||||||0.0108||||||No adjustments for multiplicity. No a priori threshold defined.|ANCOVA|Adjusted for baseline SUVr, age, and diagnosis group (AD/MCI)||Test of whether difference in least squares mean change is 0||||0.0108
71021457|NCT01010230|141550526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24||||0.69|TWO_SIDED|95.0|-5.59|3.11||The threshold for significance was established a priori at alpha=0.05.|ANOVA|BMC was normalized for height and adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8% we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||3.11|-5.59|0.69
71054186|NCT05502081|141612494|SUPERIORITY|||||||0.06|||||||Kruskal-Wallis|||||||0.06
70932783|NCT05485805|141365786|OTHER||Geometric LS means|5.471|||<|0.001|TWO_SIDED|95.0|4.141|6.801|||ANCOVA|||0-2 hours post-dose||6.801|4.141|< 0.001
70932784|NCT05485805|141365786|OTHER||Geometric LS means|7.383|||<|0.001|TWO_SIDED|95.0|6.033|8.732|||ANCOVA|||0-2 hours post-dose||8.732|6.033|< 0.001
70932785|NCT05485805|141365786|OTHER||Geometric LS means|5.78|||<|0.001|TWO_SIDED|95.0|4.43|7.131|||ANCOVA|||0-2 hours post-dose||7.131|4.43|< 0.001
71054187|NCT05502081|141612494|SUPERIORITY|||||||0.156|||||||Kruskal-Wallis|||||||0.156
71054188|NCT05502081|141612494|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
71054189|NCT05502081|141612495|SUPERIORITY|||||||0.219|||||||Kruskal-Wallis|||||||0.219
71054190|NCT05502081|141612496|SUPERIORITY|||||||0.298|||||||Kruskal-Wallis|||||||0.298
71054191|NCT05502081|141612497|SUPERIORITY|||||||0.015|||||||Kruskal-Wallis|||||||0.015
71054192|NCT05502081|141612497|SUPERIORITY|||||||0.232|||||||Kruskal-Wallis|||||||0.232
71054193|NCT05502081|141612497|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
71054194|NCT05502081|141612497|SUPERIORITY|||||||0.054|||||||Kruskal-Wallis|||||||0.054
71054195|NCT05502081|141612498|SUPERIORITY|||||||0.68|||||||Kruskal-Wallis|||||||0.68
71054196|NCT05502081|141612498|SUPERIORITY|||||||0.232|||||||Kruskal-Wallis|||||||0.232
71054197|NCT05502081|141612498|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
71054198|NCT05502081|141612498|SUPERIORITY|||||||0.054|||||||Kruskal-Wallis|||||||0.054
71054199|NCT05502081|141612499|SUPERIORITY|||||||0.002|||||||Kruskal-Wallis|||||||0.002
71054200|NCT05502081|141612499|SUPERIORITY|||||||0.557|||||||Kruskal-Wallis|||||||0.557
71054201|NCT05502081|141612499|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
71054202|NCT05502081|141612499|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
71054203|NCT05502081|141612500|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054204|NCT05502081|141612500|SUPERIORITY|||||||0.51|||||||Kruskal-Wallis|||||||0.51
71054205|NCT05502081|141612500|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054206|NCT05502081|141612500|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054207|NCT05502081|141612501|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054208|NCT05502081|141612501|SUPERIORITY|||||||0.891|||||||Kruskal-Wallis|||||||0.891
71054209|NCT05502081|141612501|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054210|NCT05502081|141612501|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054211|NCT05502081|141612502|SUPERIORITY|||||||0.516|||||||Kruskal-Wallis|||||||0.516
71054212|NCT05502081|141612503|SUPERIORITY|||||||0.264|||||||Wilcoxon (Mann-Whitney)|||||||0.264
71054213|NCT05502081|141612504|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054214|NCT05502081|141612504|SUPERIORITY|||||||0.256|||||||Kruskal-Wallis|||||||0.256
71054215|NCT05502081|141612504|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054216|NCT05502081|141612504|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054217|NCT05502081|141612505|SUPERIORITY|||||||0.008|||||||Kruskal-Wallis|||||||0.008
71054218|NCT05502081|141612505|SUPERIORITY|||||||0.797|||||||Kruskal-Wallis|||||||0.797
71054219|NCT05502081|141612505|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
71054220|NCT05502081|141612505|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
71054221|NCT05502081|141612506|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
71054222|NCT05502081|141612507|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054223|NCT05502081|141612507|SUPERIORITY|||||||0.982|||||||Kruskal-Wallis|||||||0.982
71054224|NCT05502081|141612507|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054225|NCT05502081|141612507|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054226|NCT05502081|141612508|SUPERIORITY|||||||0.015|||||||Kruskal-Wallis|||||||0.015
71054227|NCT05502081|141612508|SUPERIORITY|||||||0.136|||||||Kruskal-Wallis|||||||0.136
71054228|NCT05502081|141612508|SUPERIORITY|||||||0.062|||||||Kruskal-Wallis|||||||0.062
71054229|NCT05502081|141612508|SUPERIORITY|||||||0.005|||||||Kruskal-Wallis|||||||0.005
71054230|NCT05502081|141612509|SUPERIORITY|||||||0.136|||||||Wilcoxon (Mann-Whitney)|||||||0.136
71054231|NCT05502081|141612510|SUPERIORITY|||||||0.687|||||||Kruskal-Wallis|||||||0.687
71054232|NCT05502081|141612511|SUPERIORITY|||||||0.278|||||||Kruskal-Wallis|||||||0.278
71054233|NCT05502081|141612512|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||||||0.99
71054234|NCT05502081|141612513|SUPERIORITY|||||||0.574|||||||Kruskal-Wallis|||||||0.574
71054235|NCT05502081|141612514|SUPERIORITY|||||||0.017|||||||Kruskal-Wallis|||||||0.017
71054236|NCT05502081|141612514|SUPERIORITY|||||||0.017|||||||Kruskal-Wallis|||||||0.017
71054237|NCT05502081|141612514|SUPERIORITY|||||||0.041|||||||Kruskal-Wallis|||||||0.041
71054238|NCT05502081|141612514|SUPERIORITY|||||||0.616|||||||Kruskal-Wallis|||||||0.616
71054239|NCT05502081|141612515|SUPERIORITY|||||||0.99|||||||Kruskal-Wallis|||||||0.99
71054240|NCT05502081|141612516|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054241|NCT05502081|141612516|SUPERIORITY|||||||0.208|||||||Kruskal-Wallis|||||||0.208
71054242|NCT05502081|141612516|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054243|NCT05502081|141612516|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
71054244|NCT05502081|141612517|SUPERIORITY|||||||0.088|||||||Kruskal-Wallis|||||||0.088
71054245|NCT05502081|141612518|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
71054246|NCT05502081|141612519|SUPERIORITY|||||||0.006|||||||Kruskal-Wallis|||||||0.006
71054247|NCT05502081|141612519|SUPERIORITY|||||||0.151|||||||Kruskal-Wallis|||||||0.151
71054248|NCT05502081|141612519|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
71054249|NCT05502081|141612519|SUPERIORITY|||||||0.035|||||||Kruskal-Wallis|||||||0.035
71054250|NCT05502081|141612520|SUPERIORITY|||||||0.037|||||||Kruskal-Wallis|||||||0.037
71054251|NCT05502081|141612520|SUPERIORITY|||||||0.997|||||||Kruskal-Wallis|||||||0.997
71054252|NCT05502081|141612520|SUPERIORITY|||||||0.016|||||||Kruskal-Wallis|||||||0.016
71054253|NCT05502081|141612520|SUPERIORITY|||||||0.014|||||||Kruskal-Wallis|||||||0.014
71054254|NCT05502081|141612521|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
71054255|NCT05502081|141612522|SUPERIORITY|||||||0.047|||||||Kruskal-Wallis|||||||0.047
71054256|NCT05502081|141612522|SUPERIORITY|||||||0.04|||||||Kruskal-Wallis|||||||0.04
71054257|NCT05502081|141612522|SUPERIORITY|||||||0.036|||||||Kruskal-Wallis|||||||0.036
71054258|NCT05502081|141612522|SUPERIORITY|||||||0.67|||||||Kruskal-Wallis|||||||0.67
71054259|NCT05502081|141612523|SUPERIORITY|||||||0.015|||||||Kruskal-Wallis|||||||0.015
71021458|NCT01010230|141550527|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|0.18||||0.18|TWO_SIDED|95.0|0.0|0.35||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.||0.35|0.00|0.18
71021459|NCT01010230|141550528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.16||||0.85|TWO_SIDED|95.0|-6.93|9.25||The threshold for significance was established a priori at alpha=0.05|ANOVA|BMC was normalized for height and adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8% we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||9.25|-6.93|0.85
71021460|NCT01010230|141550529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.19||||0.12|TWO_SIDED|95.0|0.43|5.95||The threshold for significance was established a priori at alpha=0.05.|ANOVA|Adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||5.95|0.43|0.12
71021461|NCT01010230|141550530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.97|TWO_SIDED|95.0|-4.24|4.05||The threshold for significance was established a priori at alpha=0.05.|ANOVA|Adjusted for sex and tanner stage (from general linear model).||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||4.05|-4.24|0.97
71021462|NCT01010230|141550531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.91|TWO_SIDED|95.0|-4.05|4.68||The threshold for significance was established a priori at alpha=0.05.|ANOVA|Adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||4.68|-4.05|0.91
70851348|NCT00669409|141190547|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.9|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-25.5|5.7||||||Change at Week 2, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.7|-25.5|
70851349|NCT00669409|141190547|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|12.5|STANDARD_ERROR_OF_MEAN|8.06|||TWO_SIDED|95.0|-3.4|28.5||||||Change at Week 2, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||28.5|-3.4|
70851350|NCT00669409|141190547|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|7.83|||TWO_SIDED|95.0|-21.9|9.0||||||Change at Week 2, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.0|-21.9|
70851351|NCT00669409|141190547|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|10.3|||TWO_SIDED|95.0|-25.2|15.5||||||Change at Week 2, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||15.5|-25.2|
70851352|NCT00669409|141190547|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-21.4|11.5||||||Change at Week 2, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.5|-21.4|
70851353|NCT00669409|141190547|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.8|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-30.3|2.7||||||Change at Week 2, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.7|-30.3|
71054260|NCT05502081|141612523|SUPERIORITY|||||||0.027|||||||Kruskal-Wallis|||||||0.027
71054261|NCT05502081|141612523|SUPERIORITY|||||||0.008|||||||Kruskal-Wallis|||||||0.008
71054262|NCT05502081|141612523|SUPERIORITY|||||||0.38|||||||Kruskal-Wallis|||||||0.38
71054263|NCT05502081|141612524|SUPERIORITY|||||||0.814|||||||Kruskal-Wallis|||||||0.814
70851354|NCT00669409|141190547|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|16.1|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-0.6|32.7||||||Change at Week 2, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||32.7|-0.6|
70851355|NCT00669409|141190547|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|8.22|||TWO_SIDED|95.0|-22.9|9.5||||||Change at Week 2, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.5|-22.9|
70851356|NCT00669409|141190547|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|10.86|||TWO_SIDED|95.0|-25.5|17.4||||||Change at Week 2, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.4|-25.5|
70851357|NCT00669409|141190548|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.3|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-22.9|8.2||||||Change at Week 4, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.2|-22.9|
70851358|NCT00669409|141190548|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.9|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-34.4|-3.3||||||Change at Week 4, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.3|-34.4|
70851359|NCT00669409|141190548|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.6|STANDARD_ERROR_OF_MEAN|7.92|||TWO_SIDED|95.0|-25.2|6.1||||||Change at Week 4, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.1|-25.2|
70851360|NCT00669409|141190548|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.5|STANDARD_ERROR_OF_MEAN|7.73|||TWO_SIDED|95.0|-30.8|-0.2||||||Change at Week 4, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-0.2|-30.8|
70932786|NCT05485805|141365787|OTHER||Geometric LS means|-0.586|||<|0.001|TWO_SIDED|95.0|-0.903|-0.269|||ANCOVA|||0-2 hours post-dose||-0.269|-0.903|< 0.001
70932787|NCT05485805|141365787|OTHER||Geometric LS means|0.454|||=|0.005|TWO_SIDED|95.0|0.136|0.771|||ANCOVA|||0-2 hours post-dose||0.771|0.136|= 0.005
70932788|NCT05485805|141365787|OTHER||Geometric LS means|2.369|||<|0.001|TWO_SIDED|95.0|1.923|2.815|||ANCOVA|||0-2 hours post-dose||2.815|1.923|< 0.001
70932789|NCT05485805|141365787|OTHER||Geometric LS means|-0.169|||=|0.548|TWO_SIDED|95.0|-0.719|0.382|||ANCOVA|||0-2 hours post-dose||0.382|-0.719|= 0.548
71021463|NCT01010230|141550532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29||||0.4|TWO_SIDED|95.0|-0.69|3.11||The threshold for significance was established a priori at alpha=0.05.|ANOVA|Adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||3.11|-0.69|0.40
71021464|NCT01010230|141550533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.67||||0.73|TWO_SIDED|95.0|-2.02|3.33||The threshold for significance was established a priori at alpha=0.05.|ANOVA|Adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||3.33|-2.02|0.73
71021465|NCT01010230|141550534|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|0.2||||0.08|TWO_SIDED|95.0|0.06|0.34||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.||0.34|0.06|0.08
70932790|NCT05485805|141365787|OTHER||Geometric LS means|-0.132|||=|0.415|TWO_SIDED|95.0|-0.451|0.186|||ANCOVA|||0-2 hours post-dose||0.186|-0.451|= 0.415
70932791|NCT05485805|141365787|OTHER||Geometric LS means|2.823|||<|0.001|TWO_SIDED|95.0|2.377|3.268|||ANCOVA|||0-2 hours post-dose||3.268|2.377|< 0.001
70932792|NCT05485805|141365787|OTHER||Geometric LS means|2.201|||<|0.001|TWO_SIDED|95.0|1.748|2.654|||ANCOVA|||0-2 hours post-dose||2.654|1.748|< 0.001
70932793|NCT05485805|141365787|OTHER||Geometric LS means|2.237|||<|0.001|TWO_SIDED|95.0|1.791|2.683|||ANCOVA|||0-2 hours post-dose||2.683|1.791|< 0.001
70932794|NCT05485805|141365787|OTHER||Geometric LS means|2.654|||<|0.001|TWO_SIDED|95.0|2.202|3.106|||ANCOVA|||0-2 hours post-dose||3.106|2.202|< 0.001
71021466|NCT01010230|141550535|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|0.13||||0.17|TWO_SIDED|95.0|0.0|0.26||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.||0.26|0.00|0.17
71021467|NCT01010230|141550536|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|0.08||||0.38|TWO_SIDED|95.0|-0.04|0.2||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.||0.20|-0.04|0.38
71054264|NCT05502081|141612525|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
70932795|NCT05485805|141365787|OTHER||Geometric LS means|2.068|||<|0.001|TWO_SIDED|95.0|1.615|2.521|||ANCOVA|||0-2 hours post-dose||2.521|1.615|< 0.001
70932796|NCT05485805|141365787|OTHER||Geometric LS means|-1.338|||<|0.001|TWO_SIDED|95.0|-2.133|-0.542|||ANCOVA|||0-4 hours post-dose||-0.542|-2.133|< 0.001
71054265|NCT05502081|141612526|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054266|NCT05502081|141612526|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054267|NCT05502081|141612526|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
70932797|NCT05485805|141365787|OTHER||Geometric LS means|1.016|||=|0.012|TWO_SIDED|95.0|0.22|1.813|||ANCOVA|||0-4 hours post-dose||1.813|0.22|= 0.012
70932798|NCT05485805|141365787|OTHER||Geometric LS means|5.982|||<|0.001|TWO_SIDED|95.0|4.864|7.101|||ANCOVA|||0-4 hours post-dose||7.101|4.864|< 0.001
70932799|NCT05485805|141365787|OTHER||Geometric LS means|-1.048|||=|0.136|TWO_SIDED|95.0|-2.428|0.332|||ANCOVA|||0-4 hours post-dose||0.332|-2.428|= 0.136
70932800|NCT05485805|141365787|OTHER||Geometric LS means|-0.321|||=|0.43|TWO_SIDED|95.0|-1.119|0.477|||ANCOVA|||0-4 hours post-dose||0.477|-1.119|= 0.43
70932801|NCT05485805|141365787|OTHER||Geometric LS means|6.999|||<|0.001|TWO_SIDED|95.0|5.881|8.116|||ANCOVA|||0-4 hours post-dose||8.116|5.881|< 0.001
70932802|NCT05485805|141365787|OTHER||Geometric LS means|4.934|||<|0.001|TWO_SIDED|95.0|3.798|6.07|||ANCOVA|||0-4 hours post-dose||6.07|3.798|< 0.001
70932803|NCT05485805|141365787|OTHER||Geometric LS means|5.661|||<|0.001|TWO_SIDED|95.0|4.543|6.779|||ANCOVA|||0-4 hours post-dose||6.779|4.543|< 0.001
70932804|NCT05485805|141365787|OTHER||Geometric LS means|5.951|||<|0.001|TWO_SIDED|95.0|4.816|7.085|||ANCOVA|||0-4 hours post-dose||7.085|4.816|< 0.001
70932805|NCT05485805|141365787|OTHER||Geometric LS means|4.613|||<|0.001|TWO_SIDED|95.0|3.478|5.749|||ANCOVA|||0-4 hours post-dose||5.749|3.478|< 0.001
70932806|NCT05485805|141365787|OTHER||Geometric LS means|-1.963|||=|0.003|TWO_SIDED|95.0|-3.254|-0.673|||ANCOVA|||0-6 hours post-dose||-0.673|-3.254|= 0.003
70932807|NCT05485805|141365787|OTHER||Geometric LS means|1.641|||=|0.013|TWO_SIDED|95.0|0.35|2.933|||ANCOVA|||0-6 hours post-dose||2.933|0.35|= 0.013
70932808|NCT05485805|141365787|OTHER||Geometric LS means|9.191|||<|0.001|TWO_SIDED|95.0|7.377|11.006|||ANCOVA|||0-6 hours post-dose||11.006|7.377|< 0.001
71054268|NCT05502081|141612526|SUPERIORITY|||||||0.971|||||||Kruskal-Wallis|||||||0.971
71054269|NCT05502081|141612527|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
71054270|NCT05502081|141612527|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
70932809|NCT05485805|141365787|OTHER||Geometric LS means|-1.642|||=|0.15|TWO_SIDED|95.0|-3.881|0.597|||ANCOVA|||0-6 hours post-dose||0.597|-3.881|= 0.15
71054271|NCT05502081|141612528|SUPERIORITY|||||||0.007|||||||Kruskal-Wallis|||||||0.007
71021468|NCT01010230|141550537|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|-0.02||||0.88|TWO_SIDED|95.0|-0.22|0.18||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.||0.18|-0.22|0.88
71021469|NCT01010230|141550538|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|0.28||||0.06|TWO_SIDED|95.0|0.09|0.46||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.||0.46|0.09|0.06
71021470|NCT00530439|141550545|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.014
71021471|NCT01529749|141550553|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
71021472|NCT01529749|141550554|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
71021473|NCT01529749|141550555|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
71021474|NCT01529749|141550556|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
71021475|NCT01529749|141550557|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
71021476|NCT01529749|141550558|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
71021477|NCT01529749|141550559|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
71054272|NCT05502081|141612528|SUPERIORITY|||||||0.017|||||||Kruskal-Wallis|||||||0.017
71021478|NCT01529749|141550560|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
71021479|NCT01529749|141550561|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||||||0.01
71021480|NCT01529749|141550562|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
71021481|NCT01529749|141550563|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
71021482|NCT01529749|141550564|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
71021483|NCT01529749|141550565|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
71021484|NCT01529749|141550566|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
71021485|NCT01529749|141550567|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
71021486|NCT01529749|141550568|SUPERIORITY|||||||0.49|||||||Chi-squared, Corrected|||||||0.49
71021487|NCT01529749|141550569|SUPERIORITY|||||||0.02|||||||Kruskal-Wallis|||||||0.02
71021488|NCT01335399|141550608|SUPERIORITY|||||||0.4358|||||||Stratified Log Rank|||||||0.4358
71021489|NCT01335399|141550608|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.71|0.77|1.12|||||E-Ld/Ld. Calculated using Cox proportional hazards modeling|||1.12|0.77|
71021490|NCT01335399|141550609|SUPERIORITY||CMH ESTIMATE OF COMMON ODDS RATIO|1.26||||0.2232|TWO_SIDED|95.0|0.87|1.82|||CMH ESTIMATE OF COMMON ODDS RATIO|||||1.82|0.87|0.2232
71021491|NCT01335399|141550610|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.8932|TWO_SIDED|95.0|0.82|1.19|||Stratified log rank test||Stratified by stage of disease (International Staging System 1 - 2 vs 3), age (\<75 years old vs \>= 75 years old) and ECOG performance status (0 vs 1 - 2) at randomization.|||1.19|0.82|0.8932
71021492|NCT01335399|141550612|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.4358|TWO_SIDED|95.0|0.78|1.12|||Hazard Ratio|||||1.12|0.78|0.4358
71021493|NCT02464059|141550615|SUPERIORITY||Mean Difference (Final Values)|-65.5|STANDARD_DEVIATION|207.8||0.21|TWO_SIDED|95.0|-172.4|41.3||P-value is not adjusted for multiple comparisons. A priori threshold for significance is p\<0.05.|t-test, 2 sided|||||41.3|-172.4|0.21
71021494|NCT02464059|141550616|SUPERIORITY||Mean Difference (Final Values)|-0.55|STANDARD_DEVIATION|12.6||0.86|TWO_SIDED|95.0|-7.02|5.91||P-value is not adjusted for multiple comparisons. A priori threshold for significance is p\<0.05.|t-test, 2 sided|||||5.91|-7.02|0.86
71021495|NCT03990389|141550626|SUPERIORITY|||||||0.0618||||||Three degrees of freedom for the interaction test|Mixed Models Analysis|||||||0.0618
71021496|NCT03990389|141550626|SUPERIORITY||estimated treatment effect at month 1|-2.29|STANDARD_ERROR_OF_MEAN|1.8||0.63|TWO_SIDED|||||Bonferroni correction for 3 times points|Mixed Models Analysis|||||||0.63
71021497|NCT03990389|141550626|SUPERIORITY||estimated treatment effect at month 2|-5.19|STANDARD_ERROR_OF_MEAN|1.9||0.018|TWO_SIDED|||||Bonferroni correction for 3 times points|Mixed Models Analysis|||||||0.018
71021498|NCT03990389|141550626|SUPERIORITY||estimated treatment effect at month 3|-3.3|STANDARD_ERROR_OF_MEAN|1.9||0.234|TWO_SIDED|||||Bonferroni correction for 3 times points|Mixed Models Analysis|||||||0.234
71021499|NCT03990389|141550627|OTHER|||||||0.116|||||||t-test, 2 sided|||||||0.116
71021500|NCT00331773|141550699|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This trial was designed to establish with 90% power and a two-sided significance level of 0.05 that Arm 2 (Hypofractionated 3D-CRT) results in a 5-year DFS that is not lower than Arm 1 by more than 7.65% (hazard ratio \[HR\] , 1.52). Patients analyzed according to assignment, with time-to event duration originating at random assignment. DFS distributions calculated using the Kaplan-Meier method. Treatment efficacy for DFS was tested by comparing cause-specific hazards with the log-rank statistic.|Hazard Ratio (HR)|0.85|||<|0.001|TWO_SIDED|95.0|0.64|1.14|||Log Rank||Reference arm = Conventional 3D-CRT|||1.14|0.64|<0.001
71054273|NCT05502081|141612528|SUPERIORITY|||||||0.452|||||||Kruskal-Wallis|||||||0.452
71054274|NCT05502081|141612528|SUPERIORITY|||||||0.237|||||||Kruskal-Wallis|||||||0.237
71054275|NCT05502081|141612529|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
71054276|NCT05502081|141612530|SUPERIORITY|||||||0.015|||||||Kruskal-Wallis|||||||0.015
71054277|NCT05502081|141612530|SUPERIORITY|||||||0.223|||||||Kruskal-Wallis|||||||0.223
71054278|NCT05502081|141612530|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
71054279|NCT05502081|141612530|SUPERIORITY|||||||0.05|||||||Kruskal-Wallis|||||||0.05
71054280|NCT05502081|141612531|SUPERIORITY|||||||0.423|||||||Kruskal-Wallis|||||||0.423
71054281|NCT05502081|141612532|SUPERIORITY|||||||0.429|||||||Wilcoxon (Mann-Whitney)|||||||0.429
71054282|NCT05502081|141612533|SUPERIORITY|||||||0.089|||||||Kruskal-Wallis|||||||0.089
71054283|NCT05502081|141612534|SUPERIORITY|||||||0.222|||||||Kruskal-Wallis|||||||0.222
71054284|NCT05502081|141612535|SUPERIORITY|||||||0.252|||||||Kruskal-Wallis|||||||0.252
71054285|NCT05502081|141612536|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
71054286|NCT05502081|141612537|SUPERIORITY|||||||0.007|||||||Kruskal-Wallis|||||||0.007
71054287|NCT05502081|141612537|SUPERIORITY|||||||0.382|||||||Kruskal-Wallis|||||||0.382
71054288|NCT05502081|141612537|SUPERIORITY|||||||0.017|||||||Kruskal-Wallis|||||||0.017
71054289|NCT05502081|141612537|SUPERIORITY|||||||0.002|||||||Kruskal-Wallis|||||||0.002
71054290|NCT05502081|141612538|SUPERIORITY|||||||0.457|||||||Kruskal-Wallis|||||||0.457
71054291|NCT05502081|141612539|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
71054292|NCT05502081|141612540|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||||||0.01
71054293|NCT05502081|141612540|SUPERIORITY|||||||0.605|||||||Kruskal-Wallis|||||||0.605
71054294|NCT05502081|141612540|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
71054295|NCT05502081|141612540|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||||||0.01
71054296|NCT05502081|141612541|SUPERIORITY|||||||0.293|||||||Kruskal-Wallis|||||||0.293
71054297|NCT05502081|141612542|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
71054298|NCT05502081|141612543|SUPERIORITY|||||||0.36|||||||Kruskal-Wallis|||||||0.36
71054299|NCT05502081|141612544|SUPERIORITY|||||||0.404|||||||Kruskal-Wallis|||||||0.404
71054300|NCT05502081|141612545|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054301|NCT05502081|141612545|SUPERIORITY|||||||0.234|||||||Kruskal-Wallis|||||||0.234
71054302|NCT05502081|141612545|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054303|NCT05502081|141612545|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054304|NCT05502081|141612546|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054305|NCT05502081|141612546|SUPERIORITY|||||||0.223|||||||Kruskal-Wallis|||||||0.223
71054306|NCT05502081|141612546|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054307|NCT05502081|141612546|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054308|NCT05502081|141612547|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054309|NCT05502081|141612547|SUPERIORITY|||||||0.002|||||||Kruskal-Wallis|||||||0.002
71054310|NCT05502081|141612547|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054311|NCT05502081|141612547|SUPERIORITY|||||||0.213|||||||Kruskal-Wallis|||||||0.213
71054312|NCT05502081|141612548|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054313|NCT05502081|141612548|SUPERIORITY|||||||0.478|||||||Kruskal-Wallis|||||||0.478
71054314|NCT05502081|141612548|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054315|NCT05502081|141612548|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054316|NCT05502081|141612549|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054317|NCT05502081|141612549|SUPERIORITY|||||||0.413|||||||Kruskal-Wallis|||||||0.413
71054318|NCT05502081|141612549|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054319|NCT05502081|141612549|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054320|NCT05502081|141612550|SUPERIORITY|||||||0.005|||||||Kruskal-Wallis|||||||0.005
71054321|NCT05502081|141612550|SUPERIORITY|||||||0.155|||||||Kruskal-Wallis|||||||0.155
71054322|NCT05502081|141612550|SUPERIORITY|||||||0.022|||||||Kruskal-Wallis|||||||0.022
71054323|NCT05502081|141612550|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
71054324|NCT05502081|141612551|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
71054325|NCT05502081|141612552|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054326|NCT05502081|141612552|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
71054327|NCT05502081|141612552|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71054328|NCT05502081|141612552|SUPERIORITY|||||||0.011|||||||Kruskal-Wallis|||||||0.011
71054329|NCT05502081|141612553|SUPERIORITY|||||||0.189|||||||Kruskal-Wallis|||||||0.189
71054330|NCT05502081|141612554|SUPERIORITY|||||||0.414|||||||Wilcoxon (Mann-Whitney)|||||||0.414
71054331|NCT02695537|141612572|OTHER|Single group.|||||<|0.0001||||||P-value reported above is the global test for change in seizure frequency over a 12-month period.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test with Bonferonni multiple comparison correction was used as a post-hoc analysis to indicate direction of change.||Null hypothesis is that there was no change in seizure frequency between any two assessment time points during this period of analysis. Alternative hypothesis is that there were two or more assessment time points for which change in seizure frequency was different from zero.|Generalized least squares statistical techniques were used for modeling longitudinal data after normality of seizure frequency outcome measures were achieved through log-transformations methods. The following baseline clinical variables were adjusted for: AEDs, AEDs tried, epileptic surgery, and gender. Reported results were geometric least squares mean and its associated 95% Confidence Interval. Percentage reduction in seizure frequency relative to baseline were obtained by subtracting from 1 and then multiplying by 100 at all post-baseline timepoints.|||<0.0001
71079548|NCT00822328|141666514|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||Bacterial colonies were counted for study group and placebo group on week 0, 1, 2, 3, 4, 5, 6. Significant differences between both experimental groups at the same time were determined with one-way ANOVA (significance level p = 0.05).||||<0.05
71079549|NCT04399538|141666518|SUPERIORITY||Difference in least square (LS) mean|-52.36|||<|0.0001||80.0|-60.07|-43.17|||ANCOVA|||Natural log-transformed individual relative change (RC) from baseline to Week 6 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline % liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale.||-43.17|-60.07|<0.0001
71079550|NCT04399538|141666518|SUPERIORITY||Difference in LS mean|-56.58|||<|0.0001||80.0|-63.88|-47.8|||ANCOVA|||Natural log-transformed individual relative change (RC) from baseline to Week 6 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline % liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale.||-47.80|-63.88|<0.0001
71021501|NCT00331773|141550702|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Patients who died without biochemical failure were considered as competing risk at the time of death. Patients alive without biochemical failure at last follow-up were censored at that date. Estimates were calculated using cumulative risk and non-inferiority was assessed against a HR of 1.67. The log-rank test was used with a two-sided p-value of 0.05.|Hazard Ratio (HR)|0.77|||<|0.001|TWO_SIDED|95.0|0.51|1.17|||Log Rank||Reference arm = Conventional 3D-CRT|||1.17|0.51|< 0.001
71021502|NCT00331773|141550703|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was assessed against a HR of 1.54, translated from a 5% difference in overall survival with 90% overall survival in the Conventional 3D-CRT arm. The log-rank test was used with a two-sided p-value of 0.05.|Hazard Ratio (HR)|0.95||||0.008|TWO_SIDED|95.0|0.64|1.41|||Log Rank||Reference arm = Conventional 3D-CRT|||1.41|0.64|0.008
71021503|NCT00331773|141550704|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.03||||0.85|TWO_SIDED|95.0|0.73|1.46||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Acute GI toxicity rates were tabulated and dichotomized as \< grade 2 vs ≥ grade 2. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% confidence intervals (CIs) were computed.||1.46|0.73|0.85
71021504|NCT00331773|141550704|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.31||||0.72|TWO_SIDED|95.0|0.29|5.81||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Acute GI toxicity rates were tabulated and dichotomized as \< grade 3 vs ≥ grade 3. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||5.81|0.29|0.72
71021505|NCT00331773|141550704|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.99||||0.95|TWO_SIDED|95.0|0.82|1.21||2-sided|Regression, Logistic||Reference Arm = Conventional 3D-CRT|Acute GU toxicity rates were tabulated and dichotomized as \< grade 2 vs ≥ grade 2. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||1.21|0.82|0.95
71021506|NCT00331773|141550704|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.36||||0.39|TWO_SIDED|95.0|0.67|2.74||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Acute GU toxicity rates were tabulated and dichotomized as \< grade 3 vs ≥ grade 3. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||2.74|0.67|0.39
71021507|NCT00331773|141550704|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.59||||0.005|TWO_SIDED|95.0|1.22|2.06||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Late GI toxicity rates were tabulated and dichotomized as \< grade 2 vs ≥ grade 2. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||2.06|1.22|0.005
71021508|NCT00331773|141550704|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.55||||0.19|TWO_SIDED|95.0|0.8|2.99||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Late GI toxicity rates were tabulated and dichotomized as \< grade 3 vs ≥ grade 3. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||2.99|0.80|0.19
71021509|NCT00331773|141550704|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.31||||0.009|TWO_SIDED|95.0|1.07|1.61||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Late GU toxicity rates were tabulated and dichotomized as \< grade 2 vs ≥ grade 2. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||1.61|1.07|0.009
71021510|NCT00331773|141550704|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.56||||0.22|TWO_SIDED|95.0|0.76|3.18||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Late GU toxicity rates were tabulated and dichotomized as \< grade 3 vs ≥ grade 3. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||3.18|0.76|0.22
71077924|NCT02913105|141664399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.93||||0.009|TWO_SIDED|90.0|0.89|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 7||0.97|0.89|0.0090
71021511|NCT00331773|141550705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||EPIC Bowel Domain at 6 months||||0.72
71021512|NCT00331773|141550705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.056|||||||Wilcoxon (Mann-Whitney)|||EPIC Urinary Domain at 6 months||||0.056
71021513|NCT00331773|141550705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||EPIC Sexual Domain at 6 months||||0.99
71021514|NCT00331773|141550705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||EPIC Hormonal Domain at 6 months||||0.49
71021515|NCT00331773|141550705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0037|||||||Wilcoxon (Mann-Whitney)|||EPIC Bowel Domain at 12 months||||0.0037
71021516|NCT00331773|141550705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062|||||||Wilcoxon (Mann-Whitney)|||EPIC Urinary Domain at 12 months||||0.062
71021517|NCT00331773|141550705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||EPIC Sexual Domain at 12 months||||0.94
71021518|NCT00331773|141550705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93|||||||Wilcoxon (Mann-Whitney)|||EPIC Hormonal Domain at 12 months||||0.93
71021519|NCT00331773|141550705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||EPIC Bowel Domain at 24 months||||0.12
71021520|NCT00331773|141550705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||EPIC Urinary Domain at 24 months||||0.81
71021521|NCT00331773|141550705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||EPIC Sexual Domain at 24 months||||0.69
71021522|NCT00331773|141550705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||EPIC Hormonal Domain at 24 months||||0.68
71021523|NCT00331773|141550705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.071|||||||Wilcoxon (Mann-Whitney)|||EPIC Bowel Domain at 60 months||||0.071
71021524|NCT00331773|141550705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||EPIC Urinary Domain at 60 months||||0.047
71106581|NCT00582907|141719831|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.5|TWO_SIDED|95.0|-4.0|0.0|||Signed Rank|||Null hypothesis: There are no differences between the treatment arms in the serum amyloid A levels. Since this was a secondary outcome no power calculations were performed.||0|-4|0.50
70932810|NCT05485805|141365787|OTHER||Geometric LS means|-0.322|||=|0.625|TWO_SIDED|95.0|-1.617|0.972|||ANCOVA|||0-6 hours post-dose||0.972|-1.617|= 0.625
70932811|NCT05485805|141365787|OTHER||Geometric LS means|10.833|||<|0.001|TWO_SIDED|95.0|9.02|12.645|||ANCOVA|||0-6 hours post-dose||12.645|9.02|< 0.001
70932812|NCT05485805|141365787|OTHER||Geometric LS means|7.55|||<|0.001|TWO_SIDED|95.0|5.707|9.392|||ANCOVA|||0-6 hours post-dose||9.392|5.707|< 0.001
70932813|NCT05485805|141365787|OTHER||Geometric LS means|8.869|||<|0.001|TWO_SIDED|95.0|7.055|10.683|||ANCOVA|||0-6 hours post-dose||10.683|7.055|< 0.001
70932814|NCT05485805|141365787|OTHER||Geometric LS means|9.191|||<|0.001|TWO_SIDED|95.0|7.351|11.031|||ANCOVA|||0-6 hours post-dose||11.031|7.351|< 0.001
70932815|NCT05485805|141365787|OTHER||Geometric LS means|7.228|||<|0.001|TWO_SIDED|95.0|5.386|9.07|||ANCOVA|||0-6 hours post-dose||9.07|5.386|< 0.001
71021525|NCT00331773|141550705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||EPIC Sexual Domain at 60 months||||0.4
71021526|NCT00331773|141550705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||EPIC Hormonal Domain at 60 months||||0.91
71021527|NCT00331773|141550707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||The distribution of HSCL-25 at 6 months was calculated, and Wilcoxon test statistics were used to test the null hypothesis that responses are the same across the two treatment arms versus the alternative hypothesis that they are different. Significance level = 0.0125, two-sided test.||||0.55
71021528|NCT00331773|141550707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||The distribution of HSCL-25 at 12 months was calculated, and Wilcoxon test statistics were used to test the null hypothesis that responses are the same across the two treatment arms versus the alternative hypothesis that they are different. Significance level = 0.0125, two-sided test.||||0.29
71021529|NCT00331773|141550707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||The distribution of HSCL-25 at 24 months was calculated, and Wilcoxon test statistics were used to test the null hypothesis that responses are the same across the two treatment arms versus the alternative hypothesis that they are different. Significance level = 0.0125, two-sided test.||||0.23
71054332|NCT02695537|141612573|OTHER|Single group.|||||<|0.0001||||||P-value reported above is the global test for change in seizure severity scores over a 12-month period.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test with Bonferonni multiple comparison correction was used as a post-hoc analysis to indicate direction of change.||Null hypothesis is that there was no change in seizure severity scores between any two assessment time points during this period of analysis. Alternative hypothesis is that there were two or more assessment time points for which change in seizure severity scores was different from zero.|Generalized least squares statistical techniques were used for modeling longitudinal data after normality of seizure severity score outcome measures were achieved through log-transformations methods. The following baseline clinical variables were adjusted for: AEDs, AEDs tried, epileptic surgery, and gender. Reported results were geometric least squares mean and its associated 95% Confidence Interval. Percentage reduction in seizure severity relative to baseline were obtained by subtracting from 1 and then multiplying by 100 at all post-baseline timepoints.|||<0.0001
71054333|NCT01755767|141612577|SUPERIORITY|||||||0.8006|||||||Log Rank|Stratified log rank between treatment arms adjusted for stratification factors: vascular invasion, extra-hepatic spread, and alpha fetoprotein level.||||||0.8006
71054334|NCT01755767|141612577|SUPERIORITY||Hazard Ratio (HR)|0.9682||||0.8061|TWO_SIDED|95.0|0.7483|1.2529|||Regression, Cox|Stratified Cox Regression between treatment arms adjusted for factors: vascular invasion, extra-hepatic spread, and alpha fetoprotein level.||||1.2529|0.7483|0.8061
70932816|NCT05485805|141365787|OTHER||Geometric LS means|-2.398|||=|0.009|TWO_SIDED|95.0|-4.185|-0.61|||ANCOVA|||0-8 hours post-dose||-0.61|-4.185|= 0.009
71021530|NCT00331773|141550707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||The distribution of HSCL-25 at 60 months (5 years) was calculated, and Wilcoxon test statistics were used to test the null hypothesis that responses are the same across the two treatment arms versus the alternative hypothesis that they are different. Significance level = 0.0125, two-sided test.||||0.028
71021531|NCT00331773|141550708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.037|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level = 0.05||Baseline VAS score||||0.037
71021532|NCT00331773|141550708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||Baseline index score||||0.12
71021533|NCT00331773|141550708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||6-month VAS score||||0.70
71021534|NCT00331773|141550708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||6-month index score||||0.20
71021535|NCT00331773|141550708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||12-month VAS score||||0.31
71021536|NCT00331773|141550708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||12-month index score||||0.19
71021537|NCT00331773|141550708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||24-month VAS score||||0.86
71054335|NCT01755767|141612579|SUPERIORITY|||||||0.7509|||||||Log Rank|Stratified log rank between treatment arms adjusted for stratification factors: vascular invasion, extra-hepatic spread, and alpha fetoprotein level.||||||0.7509
70932817|NCT05485805|141365787|OTHER||Geometric LS means|2.4|||=|0.009|TWO_SIDED|95.0|0.61|4.189|||ANCOVA|||0-8 hours post-dose||4.189|0.61|= 0.009
70932818|NCT05485805|141365787|OTHER||Geometric LS means|11.898|||<|0.001|TWO_SIDED|95.0|9.384|14.412|||ANCOVA|||0-8 hours post-dose||14.412|9.384|< 0.001
70932819|NCT05485805|141365787|OTHER||Geometric LS means|-2.225|||=|0.159|TWO_SIDED|95.0|-5.327|0.877|||ANCOVA|||0-8 hours post-dose||0.877|-5.327|= 0.159
70932820|NCT05485805|141365787|OTHER||Geometric LS means|0.002|||=|0.998|TWO_SIDED|95.0|-1.792|1.795|||ANCOVA|||0-8 hours post-dose||1.795|-1.792|= 0.998
70932821|NCT05485805|141365787|OTHER||Geometric LS means|14.298|||<|0.001|TWO_SIDED|95.0|11.787|16.809|||ANCOVA|||0-8 hours post-dose||16.809|11.787|< 0.001
70932822|NCT05485805|141365787|OTHER||Geometric LS means|9.673|||<|0.001|TWO_SIDED|95.0|7.12|12.226|||ANCOVA|||0-8 hours post-dose||12.226|7.12|< 0.001
70932823|NCT05485805|141365787|OTHER||Geometric LS means|11.9|||<|0.001|TWO_SIDED|95.0|9.387|14.413|||ANCOVA|||0-8 hours post-dose||14.413|9.387|< 0.001
70932824|NCT05485805|141365787|OTHER||Geometric LS means|12.073|||<|0.001|TWO_SIDED|95.0|9.523|14.623|||ANCOVA|||0-8 hours post-dose||14.623|9.523|< 0.001
70932825|NCT05485805|141365787|OTHER||Geometric LS means|9.675|||<|0.001|TWO_SIDED|95.0|7.123|12.227|||ANCOVA|||0-8 hours post-dose||12.227|7.123|< 0.001
70932826|NCT05485805|141365787|OTHER||Geometric LS means|-2.949|||=|0.043|TWO_SIDED|95.0|-5.803|-0.095|||ANCOVA|||0-12 hours post-dose||-0.095|-5.803|= 0.043
71021538|NCT00331773|141550708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||24-month index score||||0.45
71021539|NCT00331773|141550708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||60-month VAS score||||0.39
71021540|NCT00331773|141550708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||60-month index score||||0.56
71021541|NCT00830063|141550720|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.24|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.76|-0.72||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Least square (LS) mean was estimated from the corresponding analysis of covariance (ANCOVA) model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95 percent (%) confidence interval (CI) was calculated on LS mean difference.||-0.72|-1.76|<0.001
71021542|NCT00830063|141550720|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.52|-0.49||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.49|-1.52|<0.001
71054336|NCT01755767|141612579|SUPERIORITY||Hazard Ratio (HR)|0.9557||||0.716|TWO_SIDED|95.0|0.7487|1.22|||Regression, Cox|Stratified Cox regression between treatment arms adjusted for factors: vascular invasion, extra-hepatic spread, and alpha fetoprotein level.||||1.2200|0.7487|0.7160
71054337|NCT03464630|141612582|SUPERIORITY|||||||0.503||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.503
71054338|NCT03464630|141612583|SUPERIORITY||||||<|0.001||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||<0.001
71054339|NCT03464630|141612584|SUPERIORITY|||||||0.059||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.059
71021543|NCT00830063|141550720|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.26||0.007|TWO_SIDED|95.0|-1.23|-0.2||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.20|-1.23|0.007
71021544|NCT00830063|141550720|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.26||0.068|TWO_SIDED|95.0|-0.99|0.03||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.03|-0.99|0.068
71021545|NCT00830063|141550721|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.25|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.73|-0.77||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.77|-1.73|<0.001
71021546|NCT00830063|141550721|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.03|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.51|-0.55||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.55|-1.51|<0.001
71054340|NCT03464630|141612585|SUPERIORITY|||||||0.702||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.702
71054341|NCT03464630|141612586|SUPERIORITY|||||||0.08||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.08
71054342|NCT03464630|141612587|SUPERIORITY|||||||0.09||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.09
71054343|NCT03464630|141612588|SUPERIORITY|||||||0.898||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.898
71054344|NCT03464630|141612589|SUPERIORITY|||||||0.349||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.349
71054345|NCT03464630|141612590|SUPERIORITY||||||<|0.001||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||<0.001
71054346|NCT00191165|141612591|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.45||||0.34||95.0|-0.5|1.4|||ANOVA||Mean Difference = High Dose - Label Dose|||1.40|-0.50|0.340
71054347|NCT00191165|141612592|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.388||95.0|-0.21|0.53||P-value for 12-Month Height SDS Change|ANOVA||Mean Difference = High Dose - Label Dose|||0.53|-0.21|0.388
71054348|NCT00191165|141612592|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.49||||0.061||95.0|-0.02|0.99||P-value for 24-Month Height SDS Change|ANOVA||Mean Difference = High Dose - Label Dose|||0.99|-0.02|0.061
71054349|NCT00191165|141612593|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.13||||0.088||95.0|-0.18|2.44|||ANOVA||Mean Difference = High Dose - Label Dose|||2.44|-0.18|0.088
71054350|NCT00998309|141612612|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the participatns of responders."||||=0.001
70932827|NCT05485805|141365787|OTHER||Geometric LS means|3.694|||=|0.011|TWO_SIDED|95.0|0.837|6.55|||ANCOVA|||0-12 hours post-dose||6.55|0.837|= 0.011
70932828|NCT05485805|141365787|OTHER||Geometric LS means|16.504|||<|0.001|TWO_SIDED|95.0|12.49|20.517|||ANCOVA|||0-12 hours post-dose||20.517|12.49|< 0.001
70932829|NCT05485805|141365787|OTHER||Geometric LS means|-3.437|||=|0.173|TWO_SIDED|95.0|-8.389|1.515|||ANCOVA|||0-12 hours post-dose||1.515|-8.389|= 0.173
70932830|NCT05485805|141365787|OTHER||Geometric LS means|0.744|||=|0.61|TWO_SIDED|95.0|-2.119|3.608|||ANCOVA|||0-12 hours post-dose||3.608|-2.119|= 0.61
70932831|NCT05485805|141365787|OTHER||Geometric LS means|20.197|||<|0.001|TWO_SIDED|95.0|16.189|24.206|||ANCOVA|||0-12 hours post-dose||24.206|16.189|< 0.001
71054351|NCT00998309|141612613|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years  in the participatns of responders."||||=1.000
71021547|NCT00830063|141550721|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.24||0.002|TWO_SIDED|95.0|-1.24|-0.28||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.28|-1.24|0.002
71021548|NCT00830063|141550721|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.24||0.03|TWO_SIDED|95.0|-1.01|-0.05||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.05|-1.01|0.030
71021549|NCT00830063|141550722|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.5|-0.16||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.16|-0.50|<0.001
71021550|NCT00830063|141550722|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.09||0.014|TWO_SIDED|95.0|-0.39|-0.04||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.04|-0.39|0.014
71021551|NCT00830063|141550722|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.09||0.026|TWO_SIDED|95.0|-0.36|-0.02||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.02|-0.36|0.026
71021552|NCT00830063|141550722|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.09||0.349|TWO_SIDED|95.0|-0.25|0.09||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.09|-0.25|0.349
71021553|NCT00830063|141550723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.24||0.355|TWO_SIDED|95.0|-0.69|0.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.25|-0.69|0.355
71021554|NCT00830063|141550723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.24||0.017|TWO_SIDED|95.0|-1.04|-0.1||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.10|-1.04|0.017
71021555|NCT00830063|141550723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.56|STANDARD_ERROR_OF_MEAN|0.24||0.02|TWO_SIDED|95.0|0.09|1.03||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||1.03|0.09|0.020
71021556|NCT00830063|141550723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.24||0.388|TWO_SIDED|95.0|-0.26|0.67||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.67|-0.26|0.388
71021557|NCT00830063|141550723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.18|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.65|-0.7||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.70|-1.65|<0.001
71021558|NCT00830063|141550723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.07|-1.13||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.13|-2.07|<0.001
71021559|NCT00830063|141550723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.24||0.274|TWO_SIDED|95.0|-0.73|0.21||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.21|-0.73|0.274
71021560|NCT00830063|141550723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.24||0.004|TWO_SIDED|95.0|-1.16|-0.22||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.22|-1.16|0.004
71021561|NCT00830063|141550723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.25|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.74|-0.75||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.75|-1.74|<0.001
71021562|NCT00830063|141550723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-2.0|-1.01||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.01|-2.00|<0.001
71021563|NCT00830063|141550723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.25||0.051|TWO_SIDED|95.0|-0.99|0.0||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.00|-0.99|0.051
70932832|NCT05485805|141365787|OTHER||Geometric LS means|13.067|||<|0.001|TWO_SIDED|95.0|8.992|17.143|||ANCOVA|||0-12 hours post-dose||17.143|8.992|< 0.001
71021564|NCT00830063|141550723|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.75|STANDARD_ERROR_OF_MEAN|0.25||0.003|TWO_SIDED|95.0|-1.24|-0.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.25|-1.24|0.003
71021565|NCT00830063|141550723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.59|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.12|-1.07||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference||-1.07|-2.12|<0.001
71021566|NCT00830063|141550723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.37|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.9|-0.85||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference||-0.85|-1.90|<0.001
71021567|NCT00830063|141550723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.89|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.42|-0.37||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.37|-1.42|<0.001
71021568|NCT00830063|141550723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.27||0.012|TWO_SIDED|95.0|-1.19|-0.15||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.15|-1.19|0.012
71021569|NCT00830063|141550724|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.24||0.355|TWO_SIDED|95.0|-0.69|0.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.25|-0.69|0.355
71021570|NCT00830063|141550724|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.24||0.017|TWO_SIDED|95.0|-1.04|-0.1||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.10|-1.04|0.017
71054352|NCT00998309|141612614|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was type of infection. The null hypothesis is there is no difference amang Skin and Soft Tissue Infection, Sexual Transmitted Infection, and Dental and Oral Surgery Infection in the participatns of responders."||||<0.001
71021571|NCT00830063|141550724|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.56|STANDARD_ERROR_OF_MEAN|0.24||0.02|TWO_SIDED|95.0|0.09|1.03||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||1.03|0.09|0.020
71021572|NCT00830063|141550724|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.24||0.388|TWO_SIDED|95.0|-0.26|0.67||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.67|-0.26|0.388
71106582|NCT00582907|141719832|SUPERIORITY_OR_OTHER||Median Difference (Net)|-6.5||||0.021|TWO_SIDED|95.0|-11.1|-2.3|||Signed rank|||Null hypothesis: There are no significant differences in the physical health-related quality of life between rilonacept and placebo. As a secondary measure there were no power calculations.||-2.3|-11.1|0.021
71021573|NCT00830063|141550724|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.98|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.45|-0.52||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.52|-1.45|<0.001
70932833|NCT05485805|141365787|OTHER||Geometric LS means|17.248|||<|0.001|TWO_SIDED|95.0|13.236|21.261|||ANCOVA|||0-12 hours post-dose||21.261|13.236|< 0.001
71021574|NCT00830063|141550724|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.56|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.02|-1.1||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.10|-2.02|<0.001
71021575|NCT00830063|141550724|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.24||0.361|TWO_SIDED|95.0|-0.68|0.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.25|-0.68|0.361
71021576|NCT00830063|141550724|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.25|-0.33||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.33|-1.25|<0.001
71021577|NCT00830063|141550724|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.06|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.54|-0.59||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.59|-1.54|<0.001
71021578|NCT00830063|141550724|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.57|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.04|-1.09||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.09|-2.04|<0.001
71021579|NCT00830063|141550724|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.24||0.063|TWO_SIDED|95.0|-0.93|0.02||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.02|-0.93|0.063
71021580|NCT00830063|141550724|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.96|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.43|-0.48||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.48|-1.43|<0.001
71021581|NCT00830063|141550724|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.7|-0.71||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.71|-1.70|<0.001
71021582|NCT00830063|141550724|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.35|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.85|-0.86||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.86|-1.85|<0.001
71021583|NCT00830063|141550724|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.25||0.006|TWO_SIDED|95.0|-1.19|-0.21||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.21|-1.19|0.006
71021584|NCT00830063|141550724|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.85|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.34|-0.36||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.36|-1.34|<0.001
71021585|NCT00830063|141550725|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.24||0.355|TWO_SIDED|95.0|-0.69|0.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.25|-0.69|0.355
71106583|NCT00582907|141719832|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.2||||0.42|TWO_SIDED|95.0|-6.8|3.9|||Signed Rank|||||3.9|-6.8|0.42
71106584|NCT00582907|141719833|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.5||||0.136|TWO_SIDED|95.0|-2.3|9.8|||Signed rank|||Null hypothesis: There are no significant differences in the FMF Armenian Evaluation (severity) Score between rilonacept and placebo. As a secondary measure there were no power calculations.||9.8|-2.3|0.136
71106585|NCT00582907|141719834|SUPERIORITY_OR_OTHER||Median Difference (Net)|-5.0||||0.089|TWO_SIDED|95.0|-15.0|-1.0|||Signed rank|||Null hypothesis: There are no significant differences in the proportion of time participants were treated with rilonacept and placebo. As a secondary measure there were no power calculations.||-1|-15|0.089
71054353|NCT00998309|141612615|SUPERIORITY_OR_OTHER||||||=|0.556|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Infection severity. The null hypothesis is there is no difference amang mild infection, moderate infection, and severe infection in the participatns of responders."||||=0.556
71054354|NCT00998309|141612616|SUPERIORITY_OR_OTHER||||||=|0.074|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was hepatic dysfunction. The null hypothesis is there is no difference between with and without hepatic dysfunction in the participatns of responders."||||=0.074
71054355|NCT00998309|141612617|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal dysfunction. The null hypothesis is there is no difference between with and without Renal dysfunction in the participatns of responders."||||=1.000
71054356|NCT00998309|141612618|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Past medical history. The null hypothesis is there is no difference between with and without past medical history in the participatns of responders."||||=1.000
71054357|NCT00998309|141612619|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was complications. The null hypothesis is there is no difference between with and without complications  in the participatns of responders."||||=1.000
71054358|NCT00998309|141612620|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was previous antibiotic treatment history. The null hypothesis is there is no difference between with and without previous antibiotic treatment history in the participatns of responders."||||=1.000
71054359|NCT00998309|141612621|SUPERIORITY_OR_OTHER||||||=|0.47|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was comcomittant drugs. The null hypothesis is there is no difference between with and without comcomittant drugs in the participatns of responders."||||=0.470
71054360|NCT00998309|141612622|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was non-drug therapy. The null hypothesis is there is no difference between with and without non-drug therapy in the participatns of responders."||||=1.000
71021586|NCT00830063|141550725|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.24||0.017|TWO_SIDED|95.0|-1.04|-0.1||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.10|-1.04|0.017
71021587|NCT00830063|141550725|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.56|STANDARD_ERROR_OF_MEAN|0.24||0.02|TWO_SIDED|95.0|0.09|1.03||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||1.03|0.09|0.020
71021588|NCT00830063|141550725|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.24||0.388|TWO_SIDED|95.0|-0.26|0.67||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.67|-0.26|0.388
71054361|NCT00998309|141612625|SUPERIORITY_OR_OTHER||||||=|0.657|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.657
71054362|NCT00998309|141612626|SUPERIORITY_OR_OTHER||||||=|0.145|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years or \>=65 in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.145
71054363|NCT00998309|141612627|SUPERIORITY_OR_OTHER||||||=|0.005|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Type of Infection. The null hypothesis is there is no difference amang Skin and Soft Tissue Infection, Sexual Transmitted Infection, and Dental or Oral Surgery Infection in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.005
71054364|NCT00998309|141612628|SUPERIORITY_OR_OTHER||||||=|0.213|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Infection severity. The null hypothesis is there is no difference amang mild infection, moderate infection, or severe infection in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.213
71054365|NCT00998309|141612629|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with and without Hepatic Dysfunction in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=1.000
70932834|NCT05485805|141365787|OTHER||Geometric LS means|16.761|||<|0.001|TWO_SIDED|95.0|12.69|20.831|||ANCOVA|||0-12 hours post-dose||20.831|12.69|< 0.001
71054366|NCT00998309|141612630|SUPERIORITY_OR_OTHER||||||=|0.116|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without Renal Dysfunction in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.116
71054367|NCT00998309|141612631|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Past Medical History. The null hypothesis is there is no difference between with and without Past Medical History in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||<0.001
71054368|NCT00998309|141612632|SUPERIORITY_OR_OTHER||||||=|0.645|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was complications. The null hypothesis is there is no difference between with and without complications in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.645
71054369|NCT00998309|141612633|SUPERIORITY_OR_OTHER||||||=|0.679|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was previous antibiotic treatment history (PATH). The null hypothesis is there is no difference between with and without previous antibiotic treatment history (PTH) in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.679
71054370|NCT00998309|141612634|SUPERIORITY_OR_OTHER||||||=|0.234|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was comcomittant drugs. The null hypothesis is there is no difference between with and without comcomittant drugs in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.234
71054371|NCT00998309|141612635|SUPERIORITY_OR_OTHER||||||=|0.039|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was non-drug therapy. The null hypothesis is there is no difference between with and without non-drug therapy in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.039
71106586|NCT01453166|141719835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|120.0|STANDARD_DEVIATION|19.0|<|0.05||95.0|100.0|140.0|||ANOVA|||"The absolute changes has been assessed by ANOVA, in which the homogeneity of variance was assessed and the Brown-Forsythe correction was used when necessary. In cases of statistically significant differences between groups, we used multiple comparisons with Bonferroni adjustment to locate the differences. Was considered statistically significant p values \<0.05. All analyzes were performed following the principle of intention to treat."||140|100|<0.05
71106587|NCT01453166|141719836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|78.0|STANDARD_DEVIATION|15.0||0.05||95.0|66.0|95.0|||ANOVA|||||95|66|0.05
71106588|NCT01453166|141719837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|170.0|STANDARD_DEVIATION|39.0||0.05||95.0|140.0|220.0|||ANOVA|||"The absolute changes has been assessed by ANOVA, in which the homogeneity of variance was assessed and the Brown-Forsythe correction was used when necessary. In cases of statistically significant differences between groups, we used multiple comparisons with Bonferroni adjustment to locate the differences. Was considered statistically significant p values \<0.05. All analyzes were performed following the principle of intention to treat."||220|140|0.05
71106589|NCT01453166|141719838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|100.0|STANDARD_DEVIATION|12.0||0.05||95.0|88.0|112.0|||ANOVA|||"The absolute changes has been assessed by ANOVA, in which the homogeneity of variance was assessed and the Brown-Forsythe correction was used when necessary. In cases of statistically significant differences between groups, we used multiple comparisons with Bonferroni adjustment to locate the differences. Was considered statistically significant p values \<0.05. All analyzes were performed following the principle of intention to treat."||112|88|0.05
71106590|NCT01453166|141719839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|100.0|STANDARD_DEVIATION|30.0||0.05||95.0|77.0|137.0|||ANOVA|||"The absolute changes has been assessed by ANOVA, in which the homogeneity of variance was assessed and the Brown-Forsythe correction was used when necessary. In cases of statistically significant differences between groups, we used multiple comparisons with Bonferroni adjustment to locate the differences. Was considered statistically significant p values \<0.05. All analyzes were performed following the principle of intention to treat."||137|77|0.05
71106591|NCT01155050|141719850|SUPERIORITY|||||||0.296|||||||ANOVA|||The null hypothesis is that there are no differences in the outcome across groups.||||.296
71106592|NCT01155050|141719851|SUPERIORITY|||||||0.787|||||||ANOVA|||The null hypothesis is that there are no differences in the outcome across groups.||||.787
71106593|NCT01155050|141719852|SUPERIORITY|||||||0.34|||||||ANOVA|||The null hypothesis is that there are no differences in the outcome across groups.||||.340
71106594|NCT01155050|141719853|SUPERIORITY|||||||0.502|||||||ANOVA|||The null hypothesis is that there are no differences in the outcome across groups.||||.502
71106595|NCT01155050|141719854|SUPERIORITY|||||||0.86|||||||ANOVA|||The null hypothesis is that the outcome does not differ across the four groups.||||.860
71106596|NCT01155050|141719855|SUPERIORITY|||||||0.634|||||||ANOVA|||The null hypothesis is that the outcome does not differ across the four groups.||||.634
71106597|NCT01155050|141719856|SUPERIORITY|||||||0.879|||||||ANOVA|||The null hypothesis is that there is no difference in the outcome across the four treatment groups.||||.879
71106598|NCT01959529|141719862|NON_INFERIORITY|Non-inferiority of IDeg to IGlar was considered confirmed if the upper limit of the two-sided 95% confidence interval for the HR was below 1.3 or equivalent if the p-value for the one-sided test of null hypothesis (H0): HR≥1.3 against the alternative hypothesis (Ha): HR\<1.3 was less than 2.5%.|Hazard Ratio (HR)|0.908|||<|0.001|TWO_SIDED|95.0|0.781|1.055||p value : Refers to one-sided test of HR \>= 1.3 (against Ha: HR\<1.3).|Regression, Cox|||The hazard ratio (HR) (IDeg vs IGlar) was based on Cox regression with investigational medicinal product as only factor for primary analysis.||1.055|0.781|<0.001
71106599|NCT01959529|141719863|SUPERIORITY||Rate ratio|0.601|||<|0.001|TWO_SIDED|95.0|0.476|0.759||p-value : Refers to one-sided test of RR \>= 1.0 (against Ha: RR\<1.0)|Negative binomial regression|The model included treatment (IDeg vs IGlar) as a fixed factor and was fitted using the FAS.||Superiority was considered confirmed if the upper limit of the two-sided 95% confidence interval for the rate ratio (RR) was below 1.0 or equivalent if the p-value for the one-sided test of H0: RR ≥1.0 against Ha: RR \<1.0, was less than 2.5%||0.759|0.476|<0.001
71106600|NCT01959529|141719864|SUPERIORITY||Odds Ratio (OR)|0.729|||<|0.001|TWO_SIDED|95.0|0.6|0.866||p-value: Refers to one-sided test of OR \>= 1.0 (against Ha: OR\<1.0)|Regression, Logistic|The model was logistic regression with log-link function.The model included treatment (IDeg vs IGlar) as a fixed factor and was fitted using the FAS||Superiority of IDeg to IGlar was considered confirmed if the upper limit of the two-sided 95% confidence interval for the odds ratio (OR) was below 1.0 or equivalent if the p-value for the one-sided test of H0: OR ≥1.0 against Ha: OR\<1.0, was less than 2.5%.||0.866|0.600|<0.001
71106601|NCT00652834|141719866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.05|TWO_SIDED|95.0||||The p value is only for GSRS score comparison only.|t-test, 2 sided||The GSRS range is 1-7|"The results of the initial SBCE exams were evaluated by a visually challenged GI specialist who gave us a descriptive report. By the end of the study, we submitted the final reports to the same specialist and asked his impression on the significant changes observed in patients' exams for each GI segment (stomach and small bowel).~There were no comparison groups. Each patient is their own control. Given that this is a pilot study there is no power calculation."||||0.05
71106602|NCT00854360|141719907|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.26||0.255|TWO_SIDED|95.0|-0.8|0.21||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.21|-0.80|0.255
71106603|NCT00854360|141719907|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.25||0.257|TWO_SIDED|95.0|-0.78|0.21||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.21|-0.78|0.257
71054372|NCT00998309|141612636|SUPERIORITY_OR_OTHER||||||=|0.605|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Pregnancy in Female. The null hypothesis is there is no difference between with and without Pregnancy in the Incidence Rate of Treatment Related Adverse Events (TRAEs) in Female."||||=0.605
70851361|NCT00669409|141190548|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-27.9|STANDARD_ERROR_OF_MEAN|10.25|||TWO_SIDED|95.0|-48.1|-7.6||||||Change at Week 4, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-7.6|-48.1|
70851362|NCT00669409|141190548|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-21.3|9.9||||||Change at Week 4, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.9|-21.3|
70932835|NCT05485805|141365787|OTHER||Geometric LS means|13.812|||<|0.001|TWO_SIDED|95.0|9.738|17.886|||ANCOVA|||0-12 hours post-dose||17.886|9.738|< 0.001
71054373|NCT00555152|141612649|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1
71054374|NCT02348723|141612669|SUPERIORITY_OR_OTHER||Risk Difference (RD) %|-5.3||||0.0009|TWO_SIDED|95.0|-8.4|-2.2|||Chi-squared|||The risk difference between dabigatran etexilate vs. warfarin, its 2-sided 95% CI, and corresponding p-value are presented.||-2.2|-8.4|0.0009
71054375|NCT01330420|141612676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon signed-ranked test|||Due to the small sample size, the Wilcoxon signed-ranked test, a non-parametric statistical test, was used to detect outcome measure changes from pre-intervention to post-intervention||||<.001
71054376|NCT01330420|141612677|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon signed-ranked test|||Due to the small sample size, the Wilcoxon signed-ranked test, a non-parametric statistical test, was used to detect outcome measure changes from pre-intervention to post-intervention||||<.001
71054377|NCT01330420|141612678|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon signed-ranked test|||Due to the small sample size, the Wilcoxon signed-ranked test, a non-parametric statistical test, was used to detect outcome measure changes from pre-intervention to post-intervention||||<.01
71054378|NCT01330420|141612680|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon signed-ranked test|||Due to the small sample size, the Wilcoxon signed-ranked test, a non-parametric statistical test, was used to detect outcome measure changes from pre-intervention to post-intervention||||<.01
71054379|NCT01197755|141612700|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.17||||0.004|TWO_SIDED|95.0|0.05|0.28||Week 24|Mantel Haenszel|Treatment difference in proportion of responders at Week 24 with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.28|0.05|0.004
71054380|NCT01197755|141612700|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.07||||0.168|TWO_SIDED|95.0|-0.03|0.18||Week 24|Mantel Haenszel|Treatment difference in proportion of responders at Week 24 with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.18|-0.03|0.168
71054381|NCT01197755|141612701|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.22|||<|0.001|TWO_SIDED|95.0|0.16|0.29|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.29|0.16|<0.001
71054382|NCT01197755|141612702|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.1||||0.014|TWO_SIDED|95.0|0.02|0.19|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.19|0.02|0.014
71054383|NCT01197755|141612702|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.05||||0.18|TWO_SIDED|95.0|-0.02|0.12||Nominal p-value presented for Group B comparison. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (primary variable comparison of Group B versus Group C was non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.12|-0.02|0.180
71054384|NCT01197755|141612703|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.12|||<|0.001|TWO_SIDED|95.0|0.06|0.19|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.19|0.06|<0.001
71106604|NCT00854360|141719907|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.25||0.013|TWO_SIDED|95.0|-1.13|-0.13||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||-0.13|-1.13|0.013
71106605|NCT00854360|141719908|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.25||0.278|TWO_SIDED|95.0|-0.77|0.22||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.22|-0.77|0.278
71106606|NCT00854360|141719908|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.25||0.385|TWO_SIDED|95.0|-0.7|0.27||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.27|-0.70|0.385
71106607|NCT00854360|141719908|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.25||0.016|TWO_SIDED|95.0|-1.09|-0.11||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated Measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||-0.11|-1.09|0.016
71106608|NCT00854360|141719909|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.26||0.082|TWO_SIDED|95.0|-0.95|0.06||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.06|-0.95|0.082
71106609|NCT00854360|141719909|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.25||0.114|TWO_SIDED|95.0|-0.9|0.1||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.10|-0.90|0.114
71106610|NCT00854360|141719909|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.26||0.001|TWO_SIDED|95.0|-1.33|-0.33||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||-0.33|-1.33|0.001
71106611|NCT00854360|141719910|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.23||0.747|TWO_SIDED|95.0|-0.52|0.37||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|ANCOVA|Results obtained from ANCOVA with treatment, baseline and center in the model.||A priori threshold for statistical significance is p\<0.05.||0.37|-0.52|0.747
71106612|NCT00854360|141719910|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.21||0.605|TWO_SIDED|95.0|-0.53|0.31||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|ANCOVA|Results obtained from ANCOVA with treatment, baseline and center in the model.||A priori threshold for statistical significance is p\<0.05.||0.31|-0.53|0.605
71106613|NCT00854360|141719910|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.23||0.083|TWO_SIDED|95.0|-0.84|0.05||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|ANCOVA|Results obtained from ANCOVA with treatment, baseline and center in the model.||A priori threshold for statistical significance is p\<0.05.||0.05|-0.84|0.083
70851363|NCT00669409|141190548|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-17.0|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-32.6|-1.4||||||Change at Week 4, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-1.4|-32.6|
70932836|NCT05485805|141365787|OTHER||Geometric LS means|-2.312|||=|0.473|TWO_SIDED|95.0|-8.635|4.011|||ANCOVA|||0-24 hours post-dose||4.011|-8.635|= 0.473
71054385|NCT01197755|141612703|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.0||||0.891|TWO_SIDED|95.0|-0.04|0.04||Nominal p-value presented for Group B comparison. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (primary variable comparison of Group B versus Group C was non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.04|-0.04|0.891
71054386|NCT01197755|141612704|SUPERIORITY_OR_OTHER||Treatment difference|||||0.01||||||Nominal p-value presented for treatment comparison. ACRn was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-values are estimated using the Van Elteren test stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||||0.010
71054387|NCT01197755|141612704|SUPERIORITY_OR_OTHER|||||||0.019||||||Nominal p-value presented for treatment comparison. ACRn was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-values are estimated using the Van Elteren test stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||||0.019
71054388|NCT01197755|141612705|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1||||0.023|TWO_SIDED|95.0|1.21|13.91|||Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||13.91|1.21|0.023
71054389|NCT01197755|141612705|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3||||0.197|TWO_SIDED|95.0|0.65|8.23||Nominal p-value presented for Group B comparison. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (primary variable comparison of Group B versus Group C was non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||8.23|0.65|0.197
71054390|NCT01197755|141612706|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1||||0.005|TWO_SIDED|95.0|1.54|10.92|||Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||10.92|1.54|0.005
71054391|NCT01197755|141612706|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.7||||0.002|TWO_SIDED|95.0|1.79|12.3||Nominal p-value presented for Group B comparison. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (primary variable comparison of Group B versus Group C was non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||12.30|1.79|0.002
71054392|NCT01197755|141612707|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.27|||<|0.001|TWO_SIDED|95.0|1.86|5.76||Nominal p value only. This was not included in the pre-defined multiplicity testing procedure.|Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data||5.76|1.86|<0.001
71054393|NCT01197755|141612707|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.89||||0.028|TWO_SIDED|95.0|1.07|3.31||Nominal p-value only. This was not included in the pre-defined multiplicity testing procedure.|Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data||3.31|1.07|0.028
71054394|NCT01197755|141612708|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4||||0.004|TWO_SIDED|95.0|1.33|4.45|||Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using logistic regression with treatment and pooled country as factors|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||4.45|1.33|0.004
70932837|NCT05485805|141365787|OTHER||Geometric LS means|27.08|||<|0.001|TWO_SIDED|95.0|18.188|35.973|||ANCOVA|||0-24 hours post-dose||35.973|18.188|< 0.001
71106614|NCT00854360|141719911|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.23||0.989|TWO_SIDED|95.0|-0.45|0.46||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.46|-0.45|0.989
71106615|NCT00854360|141719911|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.23||0.808|TWO_SIDED|95.0|-0.39|0.5||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.50|-0.39|0.808
71106616|NCT00854360|141719911|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.23||0.195|TWO_SIDED|95.0|-0.74|0.15||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.15|-0.74|0.195
71106617|NCT00854360|141719912|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.31||0.903|TWO_SIDED|95.0|-0.64|0.57||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.57|-0.64|0.903
71106618|NCT00854360|141719912|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.31||0.952|TWO_SIDED|95.0|-0.58|0.62||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.62|-0.58|0.952
71106619|NCT00854360|141719912|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.187|TWO_SIDED|95.0|-0.99|0.19||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.19|-0.99|0.187
71106620|NCT02441218|141719913|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82|||<|0.0001|TWO_SIDED|95.0|0.75|0.9|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.90|0.75|<0.0001
71106621|NCT02441218|141719914|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.128|TWO_SIDED|95.0|0.8|1.03|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||1.03|0.80|0.128
71106622|NCT02441218|141719915|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74|||<|0.0001|TWO_SIDED|95.0|0.66|0.83|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.83|0.66|< 0.0001
71106623|NCT02441218|141719916|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.092|TWO_SIDED|95.0|0.8|1.02|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||1.02|0.80|0.092
71106624|NCT02441218|141719917|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.014|TWO_SIDED|95.0|0.58|0.94|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.94|0.58|0.0140
70851364|NCT00669409|141190548|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|8.06|||TWO_SIDED|95.0|-24.3|7.5||||||Change at Week 4, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.5|-24.3|
71106625|NCT02441218|141719918|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.89||||0.0027|TWO_SIDED|95.0|0.82|0.96|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.96|0.82|0.0027
71106626|NCT02441218|141719919|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85||||0.0002|TWO_SIDED|95.0|0.78|0.92|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.92|0.78|0.0002
71106627|NCT02441218|141719920|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.0013|TWO_SIDED|95.0|0.81|0.95|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.95|0.81|0.0013
71106628|NCT02441218|141719921|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.0002|TWO_SIDED|95.0|0.77|0.92|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.92|0.77|0.0002
71106629|NCT02441218|141719922|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82|||<|0.0001|TWO_SIDED|95.0|0.74|0.89|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate. P-value: Wald test|||0.89|0.74|< 0.0001
71021589|NCT00830063|141550725|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.18|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.65|-0.7||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.70|-1.65|<0.001
71021590|NCT00830063|141550725|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.07|-1.13||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference||-1.13|-2.07|<0.001
71021591|NCT00830063|141550725|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.24||0.274|TWO_SIDED|95.0|-0.73|0.21||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.21|-0.73|0.274
71021592|NCT00830063|141550725|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.24||0.004|TWO_SIDED|95.0|-1.16|-0.22||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.22|-1.16|0.004
71021593|NCT00830063|141550725|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.25|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.74|-0.75||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.75|-1.74|<0.001
71021594|NCT00830063|141550725|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-2.0|-1.01||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.01|-2.00|<0.001
71021595|NCT00830063|141550725|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.25||0.051|TWO_SIDED|95.0|-0.99|0.0||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.00|-0.99|0.051
71021596|NCT00830063|141550725|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.75|STANDARD_ERROR_OF_MEAN|0.25||0.003|TWO_SIDED|95.0|-1.24|-0.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.25|-1.24|0.003
71021597|NCT00830063|141550725|SUPERIORITY_OR_OTHER_LEGACY||-1.59|-1.59|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.12|-1.07||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.07|-2.12|<0.001
71021598|NCT00830063|141550725|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.37|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.9|-0.85||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.85|-1.90|<0.001
71021599|NCT00830063|141550725|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.89|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.42|-0.37||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.37|-1.42|<0.001
71021600|NCT00830063|141550725|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.27||0.012|TWO_SIDED|95.0|-1.19|-0.15||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.15|-1.19|0.012
71021601|NCT00830063|141550726|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.23||0.026|TWO_SIDED|95.0|-0.96|-0.06||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.06|-0.96|0.026
71021602|NCT00830063|141550726|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.32|-0.43||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.43|-1.32|<0.001
71021603|NCT00830063|141550726|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.22|STANDARD_ERROR_OF_MEAN|0.23||0.333|TWO_SIDED|95.0|-0.23|0.67||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.67|-0.23|0.333
71106630|NCT00806585|141719953|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.1||||0.253|TWO_SIDED|95.0|-3.1|0.8|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||0.8|-3.1|0.253
71021604|NCT00830063|141550726|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.23||0.527|TWO_SIDED|95.0|-0.59|0.3||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.30|-0.59|0.527
71021605|NCT00830063|141550726|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.03|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.48|-0.57||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.57|-1.48|<0.001
71106631|NCT00806585|141719953|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.1||||0.919|TWO_SIDED|95.0|-2.1|1.9|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||1.9|-2.1|0.919
71106632|NCT00806585|141719953|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.2||||0.829|TWO_SIDED|95.0|-2.2|1.8|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||1.8|-2.2|0.829
71021606|NCT00830063|141550726|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.71|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-2.16|-1.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.25|-2.16|<0.001
71021607|NCT00830063|141550726|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.23||0.574|TWO_SIDED|95.0|-0.58|0.32||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.32|-0.58|0.574
71021608|NCT00830063|141550726|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.81|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.26|-0.36||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.36|-1.26|<0.001
71021609|NCT00830063|141550726|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.13|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.6|-0.67||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.67|-1.60|<0.001
71021610|NCT00830063|141550726|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.64|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.1|-1.17||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.17|-2.10|<0.001
71021611|NCT00830063|141550726|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.24||0.055|TWO_SIDED|95.0|-0.92|0.01||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.01|-0.92|0.055
71021612|NCT00830063|141550726|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.96|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.42|-0.49||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.49|-1.42|<0.001
71021613|NCT00830063|141550726|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.27|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.75|-0.79||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.79|-1.75|<0.001
71054395|NCT01197755|141612708|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.186|TWO_SIDED|95.0|0.82|2.79||Nominal p-value presented for Group B comparison. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (primary variable comparison of Group B versus Group C was non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using logistic regression with treatment and pooled country as factors|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.79|0.82|0.186
71054396|NCT01197755|141612709|SUPERIORITY_OR_OTHER|||||||0.729||||||Nominal p-value only. This was not included in the pre-defined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|ANCOVA|This was performed on the ranks of the change from baseline, by pooled country, including a term for the ranks of the baseline score as covariate.||||||0.729
71054397|NCT01197755|141612709|SUPERIORITY_OR_OTHER|||||||0.019||||||Nominal p-value only. This was not included in the pre-defined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|ANCOVA|This was performed on the ranks of the change from baseline, by pooled country, including a term for the ranks of the baseline score as covariate.||||||0.019
71054398|NCT01197755|141612710|SUPERIORITY_OR_OTHER||Treatment difference|2.6||||0.009||95.0|0.65|4.56|||ANCOVA|Improvement from baseline, including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||4.56|0.65|0.009
71054399|NCT01197755|141612710|SUPERIORITY_OR_OTHER||Treatment difference|1.53||||0.118|TWO_SIDED|95.0|-0.39|3.44|||ANCOVA|Improvement from baseline, including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.44|-0.39|0.118
71021614|NCT00830063|141550726|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.47|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.95|-0.99||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.99|-1.95|<0.001
71021615|NCT00830063|141550726|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.24||0.006|TWO_SIDED|95.0|-1.15|-0.19||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.19|-1.15|0.006
71021616|NCT00830063|141550726|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.34|-0.39||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.39|-1.34|<0.001
71021617|NCT00830063|141550727|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.045|TWO_SIDED|95.0|-0.32|0.0||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.00|-0.32|0.045
71054400|NCT01197755|141612711|SUPERIORITY_OR_OTHER||Treatment difference|0.67||||0.487||95.0|-1.23|2.58|||ANCOVA|Improvement from baseline, including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.58|-1.23|0.487
71054401|NCT01197755|141612711|SUPERIORITY_OR_OTHER||Treatment difference|0.62||||0.516|TWO_SIDED|95.0|-1.26|2.51|||ANCOVA|Improvement from baseline, including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.51|-1.26|0.516
71054402|NCT00371397|141612726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.75||||0.009||95.0|||||Regression, Logistic|||hsCRP dichotomized as undetectable/detectable. Logistic regression w/generalized estimating equations(GEE)s to determine odds ratio. Assessed hsCRP at baseline at each of the three visits; 43% of the values (n = 65) were below the assay's detectable lower bound of .3 mg/dL, and thus hsCRP was dichotomized as undetectable/detectable.||||.009
71054403|NCT01284621|141612740|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by empa alone|Geometric mean ratio|96.55|STANDARD_DEVIATION|7.1|||TWO_SIDED|90.0|93.05|100.18|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||100.18|93.05|
71054404|NCT01284621|141612741|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by empa alone|Geometric mean ratio|104.47|STANDARD_DEVIATION|13.1|||TWO_SIDED|90.0|97.65|111.77|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|||111.77|97.65|
71054405|NCT01284621|141612742|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by ramipril alone|Geometric mean ratio|108.14|STANDARD_DEVIATION|14.0|||TWO_SIDED|90.0|100.51|116.35|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|||116.35|100.51|
70932838|NCT05485805|141365787|OTHER||Geometric LS means|-6.928|||=|0.215|TWO_SIDED|95.0|-17.9|4.044|||ANCOVA|||0-24 hours post-dose||4.044|-17.9|= 0.215
71021618|NCT00830063|141550727|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.03|TWO_SIDED|95.0|-0.33|-0.02||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.02|-0.33|0.030
71054406|NCT01284621|141612743|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by ramipril alone.|Geometric mean ratio|103.61|STANDARD_DEVIATION|28.0|||TWO_SIDED|90.0|89.73|119.64|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|||119.64|89.73|
71054407|NCT01284621|141612744|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by ramipril alone|Geometric mean ratio|98.67|STANDARD_DEVIATION|5.2|||TWO_SIDED|90.0|96.0|101.42|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|||101.42|96.00|
71021619|NCT00830063|141550727|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.08||0.027|TWO_SIDED|95.0|0.02|0.34||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.34|0.02|0.027
70932839|NCT05485805|141365787|OTHER||Geometric LS means|2.468|||=|0.445|TWO_SIDED|95.0|-3.876|8.813|||ANCOVA|||0-24 hours post-dose||8.813|-3.876|= 0.445
71054408|NCT01284621|141612745|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by ramipril alone.|Geometric mean ratio|98.29|STANDARD_DEVIATION|11.3|||TWO_SIDED|90.0|92.67|104.25|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|||104.25|92.67|
71054409|NCT02968849|141612768|OTHER||Hazard Ratio (HR)|1.02||||0.84|TWO_SIDED|95.0|0.81|1.3|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.30|0.81|0.84
71054410|NCT02968849|141612768|OTHER||Hazard Ratio (HR)|1.03||||0.83|TWO_SIDED|95.0|0.81|1.31|||Wald||The hazard ratio was estimated using Nelson-Aalen cumulative hazard estimates. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator..|||1.31|0.81|0.83
71054411|NCT02968849|141612779|OTHER||Hazard Ratio (HR)|1.05||||0.66|TWO_SIDED|95.0|0.85|1.28|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.28|0.85|0.66
71054412|NCT02968849|141612779|OTHER||Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.81|1.23|||Wald||The hazard ratio was estimated using Nelson-Aalen cumulative hazard estimates. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator..|||1.23|0.81|0.98
71054413|NCT02968849|141612781|OTHER||Hazard Ratio (HR)|1.15||||0.39|TWO_SIDED|95.0|0.84|1.58|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.58|0.84|0.39
71054414|NCT02968849|141612781|OTHER||Hazard Ratio (HR)|1.12||||0.5|TWO_SIDED|95.0|0.81|1.54|||Wald||The hazard ratio was estimated using Nelson-Aalen cumulative hazard estimates. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator..|||1.54|0.81|0.50
71054415|NCT02968849|141612792|OTHER||Hazard Ratio (HR)|1.03||||0.82|TWO_SIDED|95.0|0.8|1.33|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.33|0.80|0.82
71054416|NCT02968849|141612793|OTHER||Hazard Ratio (HR)|0.99||||0.98|TWO_SIDED|95.0|0.5|1.98|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.98|0.50|0.98
71054417|NCT02968849|141612794|OTHER||Hazard Ratio (HR)|1.08||||0.6|TWO_SIDED|95.0|0.8|1.47|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.47|0.80|0.60
71054418|NCT02968849|141612795|OTHER||Hazard Ratio (HR)|0.92||||0.71|TWO_SIDED|95.0|0.58|1.46|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.46|0.58|0.71
71106633|NCT00806585|141719953|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.1||||0.074|TWO_SIDED|95.0|-4.5|0.2|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||0.2|-4.5|0.074
71054419|NCT03395405|141612809|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.459|TWO_SIDED|95.0|0.33|1.64||No adjustment for multiple comparisons was made. The a priori threshold for statistical significant is 0.05.|Likelihood Ratio Test|The null hypothesis is that there is no difference in time until clinical resolution between study arms, with a two-sided alternative.|HR estimated from a Cox model|The null hypothesis is that there is no difference in time until clinical resolution between study arms, with a two-sided alternative.||1.64|0.33|0.459
71054420|NCT03395405|141612811|SUPERIORITY|||||||0.735||||||No adjustment for multiple comparisons was made. The a priori threshold for statistical significant is 0.05.|ANCOVA|Titer values were log-transformed||Includes participants in the Norovirus GII subgroup. The null hypothesis is that there is no difference in time until clinical resolution between study arms, with a two-sided alternative.||||0.735
71054421|NCT03395405|141612815|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.873|TWO_SIDED|95.0|0.19|4.06||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Likelihood Ratio Test|||Includes participants in the Norovirus GII subgroup. The null hypothesis is that there is no difference in time until first negative viral load between study arms, with a two-sided alternative.||4.06|0.19|0.873
71054422|NCT00461253|141612816|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a prevalence of current Mirena use among fertile women of 8% in Finland and 2% in Germany, it was estimated that 3,500 cases and 14,000 controls would be needed to exclude a 1.5-fold breast cancer risk for Mirena users compared with users of copper IUDs.|Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.88|1.12|||||Breast cancer OR for ever use of LNG-IUD vs. Cu-IUD; adjusted for BMI, family history of breast cancer, age at first birth, age at menarche and physical activity (primary analysis)|In this matched case-control study, conditional logistic regression was used to investigate the relationship between a woman being a breast cancer case or a control (dichotomous dependent variable), and a set of actual or potential prognostic factors (covariates) for breast cancer (incl. the use of Mirena). Conditional logistic regression uses a maximum likelihood approach for estimating the covariates; data are stratified and the likelihoods are computed relative to each stratum.||1.12|0.88|
71054423|NCT00461253|141612816|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a prevalence of current Mirena use among fertile women of 8% in Finland and 2% in Germany, it was estimated that 3,500 cases and 14,000 controls would be needed to exclude a 1.5-fold breast cancer risk for Mirena users compared with users of copper IUDs.|Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.93|1.17|||||Breast cancer OR for ever use of LNG-IUD vs. Cu-IUD, crude|In this matched case-control study, conditional logistic regression was used to investigate the relationship between a woman being a breast cancer case or a control (dichotomous dependent variable), and a set of actual or potential prognostic factors (covariates) for breast cancer (incl. the use of Mirena). Conditional logistic regression uses a maximum likelihood approach for estimating the covariates; data are stratified and the likelihoods are computed relative to each stratum.||1.17|0.93|
71054424|NCT00461253|141612816|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a prevalence of current Mirena use among fertile women of 8% in Finland and 2% in Germany, it was estimated that 3,500 cases and 14,000 controls would be needed to exclude a 1.5-fold breast cancer risk for Mirena users compared with users of copper IUDs.|Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.52|1.39|||||"Breast cancer OR for current use of LNG-IUD vs. Cu-IUD at time of breast cancer diagnosis; adjusted for BMI, family history of breast cancer, age at first birth, age at first menarche, physical activity (primary analysis)"|In this matched case-control study, conditional logistic regression was used to investigate the relationship between a woman being a breast cancer case or a control (dichotomous dependent variable), and a set of actual or potential prognostic factors (covariates) for breast cancer (incl. the use of Mirena). Conditional logistic regression uses a maximum likelihood approach for estimating the covariates; data are stratified and the likelihoods are computed relative to each stratum.||1.39|0.52|
71054425|NCT00461253|141612816|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a prevalence of current Mirena use among fertile women of 8% in Finland and 2% in Germany, it was estimated that 3,500 cases and 14,000 controls would be needed to exclude a 1.5-fold breast cancer risk for Mirena users compared with users of copper IUDs.|Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.58|1.41|||||"Breast cancer OR for current use of LNG-IUD vs. Cu-IUD at time of breast cancer diagnosis, crude"|In this matched case-control study, conditional logistic regression was used to investigate the relationship between a woman being a breast cancer case or a control (dichotomous dependent variable), and a set of actual or potential prognostic factors (covariates) for breast cancer (incl. the use of Mirena). Conditional logistic regression uses a maximum likelihood approach for estimating the covariates; data are stratified and the likelihoods are computed relative to each stratum.||1.41|0.58|
71054426|NCT04036799|141612822|OTHER|Categorical variables were summarized using frequencies and proportions.|Cumulative proportion of events at 5 yrs|9.1|||||TWO_SIDED|95.0||||||||||||
71054427|NCT04240392|141612823|SUPERIORITY||Odds Ratio (OR)|1.369||||0.534|TWO_SIDED|95.0|0.462|4.055|||Mixed Models Analysis|Generalized Linear Mixed Model||||4.055|0.462|0.5340
71054428|NCT04240392|141612824|SUPERIORITY||Odds Ratio (OR)|0.803||||0.6|TWO_SIDED|95.0|0.326|1.979|||Mixed Models Analysis|Generalized Linear Mixed Model||At delivery||1.979|0.326|0.600
71054429|NCT04240392|141612824|SUPERIORITY||Odds Ratio (OR)|0.709||||0.471|TWO_SIDED|95.0|0.254|1.975|||Mixed Models Analysis|Generalized Linear Mixed Model||At 3 months post partum||1.975|0.254|0.471
71054430|NCT04240392|141612825|SUPERIORITY||Beta-coefficient|1.53||||0.518|TWO_SIDED|95.0|-3.13|6.19|||Mixed Models Analysis|Repeated Measures Linear Mixed Model|Beta-coefficient for treatment for time interaction term|At week 36||6.19|-3.13|0.518
71106634|NCT00806585|141719953|SUPERIORITY_OR_OTHER||Difference in least squares means|1.0||||0.393|TWO_SIDED|95.0|-1.3|3.3|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||3.3|-1.3|0.393
71054431|NCT04240392|141612825|SUPERIORITY||Beta-coefficient|0.32||||0.893|TWO_SIDED|95.0|-4.41|5.06|||Mixed Models Analysis|Repeated Measures Linear Mixed Model|Beta-coefficient for treatment for time interaction term|At 3 months post partum||5.06|-4.41|0.893
71054432|NCT05307510|141612826|SUPERIORITY|Statistical analysis is under powered. N is too low.||||||0.135||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Pain at rest||||0.135
71054433|NCT05307510|141612826|SUPERIORITY|Statistical analysis is underpowered. N is too low||||||0.716||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Pain at Night||||.716
71054434|NCT05307510|141612826|SUPERIORITY|Statistical Analysis underpowered. N is too small.||||||0.509||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Pain in use||||.509
71054435|NCT05307510|141612827|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
71054436|NCT05307510|141612828|SUPERIORITY|Statistical analysis is underpowered. N is too low.||||||0.635||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Palmar abduction of surgical hand||||.635
71054437|NCT05307510|141612828|SUPERIORITY|Statistical analysis is underpowered. N is too low.|Mean Difference (Net)|-3.1||||0.521|TWO_SIDED|95.0|-13.6|7.4|||t-test, 2 sided|||Radial Abduction Surgical Hand||7.4|-13.6|.521
71054438|NCT05307510|141612829|SUPERIORITY|Statistical analysis is underpowered. N is too low.|Mean Difference (Net)|7.42||||0.495|TWO_SIDED|95.0|-16.16|32.0|||t-test, 2 sided|||||32.0|-16.16|.495
71054439|NCT05307510|141612830|SUPERIORITY|Statistical analysis is underpowered. N is too low.||||||0.953||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Buttoning Buttons||||.953
71054440|NCT05307510|141612830|SUPERIORITY|Statistical analysis is underpowered. N is too low.||||||0.947||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Lacing and tying a shoe||||.947
71054441|NCT05307510|141612830|SUPERIORITY|Statistical analysis is underpowered. N is too low.||||||0.828||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Opening and closing safety pins||||.828
71054442|NCT05307510|141612830|SUPERIORITY|Statistical analysis is underpowered. N is too low.||||||0.169||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Managing coins||||.169
71054443|NCT05307510|141612831|SUPERIORITY|Statistical analysis underpowered. N too small.||||||0.917||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||||||.917
71054444|NCT05307510|141612831|SUPERIORITY|Statistical analysis is underpowered. N is too small||||||0.837||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||||||.837
71054445|NCT01555671|141612839|OTHER||Mean Difference (Net)|30.0||||0.029|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.029
71054446|NCT03047330|141612842|SUPERIORITY|||||||0.22|||||||Mixed Models Analysis|||||||0.22
71054447|NCT03047330|141612842|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
71054448|NCT03047330|141612843|SUPERIORITY|||||||0.048|||||||Mixed Models Analysis|||||||0.048
71054449|NCT03047330|141612843|SUPERIORITY|||||||0.58|||||||Mixed Models Analysis|||||||0.58
71054450|NCT00000378|141612848|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||actual calculation|Regression, Logistic|||logistic regression and mixed effects model||||<0.05
71054451|NCT04684238|141612866|OTHER|Least square means of the difference between the treatment groups, including a 2-sided 95% confidence interval was reported in the statistical analysis. The noninferiority criterion was a relative difference of less than 15% between treatment groups.|Least square means|6.57|||||TWO_SIDED|95.0|-8.99|22.13||Noninferiority was defined as the entire 95% CI for the difference being above the noninferiority margin for the relative difference of -15%. Testing the hypothesis of no difference between isoflurane and midazolam.|Mixed Models Analysis|||||22.13|-8.99|
71054452|NCT04684238|141612867|NON_INFERIORITY|The non-inferiority margin was set to a relative difference of -15%.|Least square means|5.34|||||TWO_SIDED|95.0|-10.48|21.17||Testing the hypothesis of no difference between isoflurane and midazolam.||||||21.17|-10.48|
71054453|NCT04684238|141612868|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.0004|TWO_SIDED|95.0|-3.8|-1.1|||ANCOVA|||||-1.1|-3.8|0.0004
71054454|NCT04684238|141612869|SUPERIORITY|Results display comparison between isoflurane and midazolam and are based on an analysis of variance model with treatment group as fixed effect and baseline opioid dose as covariate.|Mean Difference (Final Values)|-0.77||||0.096|TWO_SIDED|95.0|-1.69|0.14|||ANCOVA|||||0.14|-1.69|0.096
71054455|NCT04684238|141612870|SUPERIORITY||Hazard Ratio (HR)|3.3||||0.0021|TWO_SIDED|95.0|1.54|7.07|||Regression, Cox|||Time to extubation||7.07|1.54|0.0021
71054456|NCT04684238|141612871|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.636|TWO_SIDED|95.0|-0.15|0.25|||ANOVA|||Spontaneous breathing efforts. Results display a comparison between isoflurane and midazolam and are based on a mixed effects analysis of variance model with treatment group as fixed effect.||0.25|-0.15|0.636
71054457|NCT04684238|141612872|SUPERIORITY|Results display comparison between isoflurane and midazolam and are based on a Wilcoxon ranksum test.||||||0.55|||||||Wilcoxon (Mann-Whitney)|||Need for inotropic/vasopressor agent at ≤24 hours.||||0.55
71054458|NCT04684238|141612872|SUPERIORITY|||||||0.637|||||||Wilcoxon (Mann-Whitney)|||Need for inotropic/vasopressor agent at \>24 hours.||||0.637
71054459|NCT01988129|141612880|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||t-test, 2 sided|||Analysis for 'sick' days||||0.66
71054460|NCT01988129|141612880|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||t-test, 2 sided|||Analysis for 'disability/injury' days||||0.033
71054461|NCT01988129|141612880|SUPERIORITY_OR_OTHER|||||||0.003|||||||Mixed Models Analysis|Mixed model analysis with nested random effects for possible station-level and station-pairing correlation (3-level hierarchical linear model)||Mixed model analysis was conducted for 'disability/injury' days||||0.003
71054462|NCT01988129|141612881|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||t-test, 2 sided|||||||0.87
71054463|NCT01988129|141612882|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.31|TWO_SIDED|95.0|0.6|0.98|||t-test, 2 sided||The Odds Ratio analyses compared the odds of reporting at least one injury during the study between those who did (n=560) and did not (n=629) attend the education sessions, regardless of station assignment (intervention or control).|||0.98|0.60|0.31
71021620|NCT00830063|141550727|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.08||0.04|TWO_SIDED|95.0|0.01|0.32||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.32|0.01|0.040
71021621|NCT00830063|141550727|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.66|-0.35||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.35|-0.66|<0.001
71021622|NCT00830063|141550727|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.72|-0.41||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.41|-0.72|<0.001
71021623|NCT00830063|141550727|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.041|TWO_SIDED|95.0|-0.32|-0.01||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.01|-0.32|0.041
71021624|NCT00830063|141550727|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.006|TWO_SIDED|95.0|-0.38|-0.06||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.06|-0.38|0.006
71021625|NCT00830063|141550727|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.6|-0.27||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.27|-0.60|<0.001
71021626|NCT00830063|141550727|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.62|-0.29||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.29|-0.62|<0.001
71021627|NCT00830063|141550727|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.011|TWO_SIDED|95.0|-0.38|-0.05||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.05|-0.38|0.011
71021628|NCT00830063|141550727|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.08||0.006|TWO_SIDED|95.0|-0.4|-0.07||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.07|-0.40|0.006
70851365|NCT00669409|141190548|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.8|STANDARD_ERROR_OF_MEAN|7.83|||TWO_SIDED|95.0|-32.2|-1.3||||||Change at Week 4, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-1.3|-32.2|
71021629|NCT00830063|141550727|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.6|-0.26||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.26|-0.60|<0.001
70932840|NCT05485805|141365787|OTHER||Geometric LS means|20.152|||<|0.001|TWO_SIDED|95.0|11.122|29.183|||ANCOVA|||0-24 hours post-dose||29.183|11.122|< 0.001
71021630|NCT00830063|141550727|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.48|-0.14||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference||-0.14|-0.48|<0.001
71021631|NCT00830063|141550727|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.08||0.003|TWO_SIDED|95.0|-0.42|-0.09||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.09|-0.42|0.003
71021632|NCT00830063|141550727|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.08||0.105|TWO_SIDED|95.0|-0.3|0.03||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.03|-0.30|0.105
71021633|NCT00830063|141550728|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.045|TWO_SIDED|95.0|-0.32|0.0||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.00|-0.32|0.045
71021634|NCT00830063|141550728|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.03|TWO_SIDED|95.0|-0.33|-0.02||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.02|-0.33|0.030
71021635|NCT00830063|141550728|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.08||0.027|TWO_SIDED|95.0|0.02|0.34||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.34|0.02|0.027
71021636|NCT00830063|141550728|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.08||0.04|TWO_SIDED|95.0|0.01|0.32||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.32|0.01|0.040
71021637|NCT00830063|141550728|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.64|-0.32||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.32|-0.64|<0.001
71021638|NCT00830063|141550728|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.74|-0.42||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.42|-0.74|<0.001
71021639|NCT00830063|141550728|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.08||0.094|TWO_SIDED|95.0|-0.3|0.02||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.02|-0.30|0.094
71021640|NCT00830063|141550728|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.08||0.003|TWO_SIDED|95.0|-0.4|-0.08||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.08|-0.40|0.003
71021641|NCT00830063|141550728|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.57|-0.23||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.23|-0.57|<0.001
71054464|NCT01988129|141612883|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Paired t-test|||Of the 100 participants who completed both the pre- and post-study survey (see Patient Flow), only 62 completed answered the question about sleep duration at both time points||||0.22
71054465|NCT01988129|141612884|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||paired t-test|||||||0.65
71054466|NCT01988129|141612885|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||paired t-test|||||||0.71
71054467|NCT01988129|141612887|SUPERIORITY_OR_OTHER||Percentage of firefighters screened|41.5|||||TWO_SIDED|||||||||This analysis describes the prevalence of the risk of any sleep disorders; there is no comparison group||||
71054468|NCT01988129|141612887|SUPERIORITY_OR_OTHER||Percentage of firefighters screene|31.3|||||TWO_SIDED|||||||||This analysis describes the prevalence of the risk of obstructive sleep apnea only; there is no comparison group||||
70932841|NCT05485805|141365787|OTHER||Geometric LS means|24.933|||<|0.001|TWO_SIDED|95.0|15.914|33.952|||ANCOVA|||0-24 hours post-dose||33.952|15.914|< 0.001
71021642|NCT00830063|141550728|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.68|-0.35||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.35|-0.68|<0.001
71021643|NCT00830063|141550728|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.032|TWO_SIDED|95.0|-0.35|-0.02||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.02|-0.35|0.032
71021644|NCT00830063|141550728|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.46|-0.13||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.13|-0.46|<0.001
71021645|NCT00830063|141550728|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.54|-0.21||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.21|-0.54|<0.001
70932842|NCT05485805|141365787|OTHER||Geometric LS means|22.621|||<|0.001|TWO_SIDED|95.0|13.594|31.648|||ANCOVA|||0-24 hours post-dose||31.648|13.594|< 0.001
70932843|NCT05485805|141365788|OTHER||||||=|0.963|||||||ANCOVA|||||||= 0.963
71054469|NCT01988129|141612887|SUPERIORITY_OR_OTHER||Percentage of firefighters screene|7.7|||||TWO_SIDED|||||||||This analysis describes the prevalence of the risk of insomnia; there is no comparison group||||
71054470|NCT01988129|141612887|SUPERIORITY_OR_OTHER||Percentage of firefighters screene|3.5|||||TWO_SIDED|||||||||This analysis describes the prevalence of the risk of restless legs syndrome only; there is no comparison group||||
71054471|NCT01988129|141612887|SUPERIORITY_OR_OTHER||Percentage of firefighters screene|9.3|||||TWO_SIDED|||||||||This analysis describes the prevalence of the risk of shiftwork disorder only; there is no comparison group||||
71054472|NCT01988129|141612888|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||paired t-test|||||||0.31
71054473|NCT01988129|141612889|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Paired t-test, 2-sided|||Sleeping while stopped in traffic||||0.16
71054474|NCT01988129|141612890|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Paired t-test, 2-sided|||||||0.46
71054475|NCT02585934|141612892|SUPERIORITY||least square mean difference|-0.36||||0.2249|TWO_SIDED|95.0|-0.95|0.22||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||0.22|-0.95|0.2249
70932844|NCT05485805|141365788|OTHER||||||=|0.118|||||||ANCOVA|||||||= 0.118
70932845|NCT05485805|141365788|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
71054476|NCT02585934|141612893|SUPERIORITY||least square mean difference|-0.09||||0.826|TWO_SIDED|95.0|-0.9|0.72||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||0.72|-0.90|0.8260
71054477|NCT02585934|141612894|SUPERIORITY||least square mean difference|-0.12||||0.0234|TWO_SIDED|95.0|-0.22|-0.02||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||-0.02|-0.22|0.0234
71054478|NCT02585934|141612895|SUPERIORITY||least square mean difference|0.12||||0.2096|TWO_SIDED|95.0|-0.07|0.32||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||0.32|-0.07|0.2096
71054479|NCT02585934|141612896|SUPERIORITY||least square mean difference|-0.14||||0.765|TWO_SIDED|95.0|-1.09|0.8||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||0.80|-1.09|0.7650
71054480|NCT02585934|141612897|SUPERIORITY||least square mean difference|-0.38||||0.2472|TWO_SIDED|95.0|-1.03|0.27||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||0.27|-1.03|0.2472
71054481|NCT04713553|141612899|EQUIVALENCE|Equivalence was to be achieved if the 2-sided 95% confidence interval (CI) for GMR falls within the interval (0.67, 1.5).|Geometric mean ratio|1.01|||||TWO_SIDED|95.0|0.91|1.13|||||GMRs and corresponding 2-sided 95% CIs were calculated by exponentiating difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of age and vaccine group.|||1.13|0.91|
71054482|NCT04713553|141612899|EQUIVALENCE|Equivalence was to be achieved if the 2-sided 95% CI for GMR falls within the interval (0.67, 1.5).|Geometric mean ratio|0.93|||||TWO_SIDED|95.0|0.83|1.04|||||GMRs and corresponding 2-sided 95% CIs were calculated by exponentiating difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of age and vaccine group.|||1.04|0.83|
71054483|NCT04713553|141612899|EQUIVALENCE|Equivalence was to be achieved if the 2-sided 95% CI for GMR falls within the interval (0.67, 1.5).|Geometric mean ratio|0.92|||||TWO_SIDED|95.0|0.82|1.03|||||GMRs and corresponding 2-sided 95% CIs were calculated by exponentiating difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of age and vaccine group.|||1.03|0.82|
71054484|NCT04713553|141612900|EQUIVALENCE|Equivalence was to be achieved if the 2-sided 95% CI for GMR falls within the interval (0.67, 1.5).|Geometric mean ratio|0.95|||||TWO_SIDED|95.0|0.84|1.07|||||GMRs and corresponding 2-sided 95% CIs were calculated by exponentiating difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of age and vaccine group.|||1.07|0.84|
71054485|NCT04713553|141612901|NON_INFERIORITY|Noninferiority of the 20 mcg dose to the corresponding 30 mcg dose was said to be achieved if the lower limit of the 2-sided 95% CI for the GMR is \>0.67.|Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.84|1.02|||||GMRs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of age and vaccine group|||1.02|0.84|
71054486|NCT00110136|141612975|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81|STANDARD_DEVIATION|2.02||0.2629|TWO_SIDED|95.0|-2.36|0.74||Paired t-test; no adjustments for multiple comparisons|paired t-test||The difference is post minus pre so negative values represents fewer hot flashes after treatment.|Analysis of the change in hot flash frequency from baseline to four weeks; null hypothesis is no change.||0.74|-2.36|0.2629
71054487|NCT00110136|141612976|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.37|STANDARD_DEVIATION|7.91||0.1365|TWO_SIDED|95.0|-10.45|1.72||Paired t-test; unadjusted for multiple comparisons.|paired t-test||Difference in hot flash score is post minus pre so a negative value represents a decrease in the frequency and/or severity of the hot flashes.|Assessment of the change in the hot flash score over time||1.72|-10.45|0.1365
71106635|NCT00806585|141719953|SUPERIORITY_OR_OTHER||Difference in least squares means|2.0||||0.088|TWO_SIDED|95.0|-0.3|4.4|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||4.4|-0.3|0.088
71106636|NCT00806585|141719953|SUPERIORITY_OR_OTHER||Difference in least squares means|1.9||||0.108|TWO_SIDED|95.0|-0.4|4.3|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||4.3|-0.4|0.108
70932846|NCT05485805|141365788|OTHER||||||=|0.244|||||||ANCOVA|||||||= 0.244
70932847|NCT05485805|141365788|OTHER||||||=|0.139|||||||ANCOVA|||||||= 0.139
70932848|NCT05485805|141365788|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
70932849|NCT05485805|141365788|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
70932850|NCT05485805|141365788|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
70932851|NCT05485805|141365788|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
70932852|NCT05485805|141365788|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
70932853|NCT05485805|141365790|OTHER||||||=|0.647|||||||ANCOVA|||||||= 0.647
70932854|NCT05485805|141365790|OTHER||||||=|0.714|||||||ANCOVA|||||||= 0.714
70932855|NCT05485805|141365790|OTHER||||||=|0.065|||||||ANCOVA|||||||= 0.065
71054488|NCT00110136|141612978|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.54|STANDARD_DEVIATION|7.0||0.832|TWO_SIDED|95.0|-4.84|5.92||Paired t-test; unadjusted for multiple comparisons.|paired t-test||This is the change in MCS from baseline to four weeks (post minus pre) so values greater than zero reflect improvement in QOL.|Assess the change in MCS from baseline to four weeks in patients receiving St. John's wort.||5.92|-4.84|0.8320
70932856|NCT05485805|141365790|OTHER||||||=|0.742|||||||ANCOVA|||||||= 0.742
70932857|NCT05485805|141365790|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
70932858|NCT05485805|141365790|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
70932859|NCT05485805|141365790|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
70932860|NCT05485805|141365790|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
70932861|NCT05485805|141365790|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
70932862|NCT05485805|141365791|OTHER||||||=|0.162|||||||ANCOVA|||||||= 0.162
70932863|NCT05485805|141365791|OTHER||||||=|0.319|||||||ANCOVA|||||||= 0.319
70932864|NCT05485805|141365791|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
70932865|NCT05485805|141365791|OTHER||||||=|0.343|||||||ANCOVA|||||||= 0.343
70932866|NCT05485805|141365791|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
70932867|NCT05485805|141365791|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
70932868|NCT05485805|141365791|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
70932869|NCT05485805|141365791|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
70932870|NCT05485805|141365791|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
70932871|NCT05485805|141365792|OTHER||||||=|0.162|||||||ANCOVA|||||||= 0.162
70932872|NCT05485805|141365792|OTHER||||||=|0.319|||||||ANCOVA|||||||= 0.319
70932873|NCT05485805|141365792|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
70932874|NCT05485805|141365792|OTHER||||||=|0.343|||||||ANCOVA|||||||= 0.343
70932875|NCT05485805|141365792|OTHER||||||=|0.772|||||||ANCOVA|||||||= 0.772
70932876|NCT05485805|141365792|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
70932877|NCT05485805|141365792|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
70932878|NCT05485805|141365792|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
70932879|NCT05485805|141365792|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
70932880|NCT05485805|141365792|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
70932881|NCT05485805|141365795|OTHER||geometric LS mean square|-0.14|||=|0.334|TWO_SIDED|95.0|-0.44|0.15|||ANCOVA|||||0.15|-0.44|= 0.334
70932882|NCT05485805|141365795|OTHER||geometric LS mean square|0.04|||=|0.783|TWO_SIDED|95.0|-0.25|0.33|||ANCOVA|||||0.33|-0.25|= 0.783
70932883|NCT05485805|141365795|OTHER||geometric LS mean square|-0.08|||=|0.687|TWO_SIDED|95.0|-0.5|0.33|||ANCOVA|||||0.33|-0.5|= 0.687
70932884|NCT05485805|141365795|OTHER||geometric LS mean square|-0.02|||=|0.927|TWO_SIDED|95.0|-0.53|0.49|||ANCOVA|||||0.49|-0.53|= 0.927
70932885|NCT05485805|141365795|OTHER||geometric LS mean square|-0.1|||=|0.492|TWO_SIDED|95.0|-0.4|0.19|||ANCOVA|||||0.19|-0.4|= 0.492
70932886|NCT05485805|141365795|OTHER||geometric LS mean square|-0.04|||=|0.836|TWO_SIDED|95.0|-0.46|0.37|||ANCOVA|||||0.37|-0.46|= 0.836
70932887|NCT05485805|141365795|OTHER||geometric LS mean square|-0.11|||=|0.611|TWO_SIDED|95.0|-0.53|0.31|||ANCOVA|||||0.31|-0.53|= 0.611
70932888|NCT05485805|141365795|OTHER||geometric LS mean square|-0.19|||=|0.371|TWO_SIDED|95.0|-0.6|0.22|||ANCOVA|||||0.22|-0.6|= 0.371
70932889|NCT05485805|141365795|OTHER||geometric LS mean square|-0.07|||=|0.752|TWO_SIDED|95.0|-0.49|0.35|||ANCOVA|||||0.35|-0.49|= 0.752
70932890|NCT05485805|141365795|OTHER||geometric LS mean square|-0.21|||=|0.321|TWO_SIDED|95.0|-0.63|0.21|||ANCOVA|||||0.21|-0.63|= 0.321
70932891|NCT01586104|141365803|OTHER|With 20 patients, there is 80% power to detect a difference of 100% with Standard lung RT versus 93% with IMRT assuming a standard deviation of 8 (as seen for the whole heart), a one tailed test and a Bonferroni correction for 4 statistical tests so that each test is done at p\<0.0125.|||||<|0.0125||||||The reported p value was calculated. The statistical analysis performed is attached to the outcome measure reported.|Bonferroni corrected at p<0.0125|||Feasibility will be defined as an enrolled patient receiving the IMRT treatment as planned. It is expected that the treatment will be feasible in at least 90% of patients. If the treatment is feasible in 16 or more out of 20 patients, then the treatment will be declared feasible. If the true feasibility rate is 90%, then there is a 4.3% chance that 15 or fewer feasible patients will be observed.|Lung-metastases-free survival will be estimated using Kaplan-Meier survival curves (minimum period of six months).|||<0.0125
70932892|NCT04218357|141365806|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||GEE|Generalized Estimating Equation with standard errors, and an unstructured correlation matrix with medication and time as within-subject factors.||All outcomes were assessed in real-time in the laboratory testing probenecid compared to placebo condition during the alcohol administration procedure.||||0.05
71054489|NCT00110136|141612979|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|7.43||0.9995|TWO_SIDED|95.0|-5.71|5.71||Paired t-test on the change in PCS from baseline to four weeks; unadjusted for multiple comparisons.|paired t-test||This is the change in PCS from baseline to four weeks (post minus pre), so positive numbers represent improvement in QOL.|Assess the change in PCS from baseline to four weeks; null hypothesis is no change.||5.71|-5.71|0.9995
71054490|NCT00110136|141612980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.35|STANDARD_DEVIATION|7.12||0.1042|TWO_SIDED|95.0|-1.12|9.822||Paired t-test; unadjusted for multiple comparisons.|paired t-test||This is the change in mood from baseline to four weeks (post minus pre). Mood is scored so that higher numbers represent better mood so positive changes represent an improvement in mood.|Assess the change in mood from baseline to four weeks. Null hypothesis is no change.||9.822|-1.12|0.1042
71079551|NCT04399538|141666518|SUPERIORITY||Difference in LS mean|-58.8|||<|0.0001||80.0|-65.66|-50.57|||ANCOVA|||Natural log-transformed individual relative change (RC) from baseline to Week 6 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline % liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. Relative change was converted to percent change as follows: Percent change = 100\*(RC-1). 80% CI was calculated based on difference in LS mean between groups.||-50.57|-65.66|<0.0001
71054491|NCT00537303|141612983|NON_INFERIORITY_OR_EQUIVALENCE|The two treatments are declared equivalent if the 95% Confidence Interval for the estimated difference in means between the two treatment groups is included in the interval from -0.4 to 0.4 for both the full analysis set and the per protocol set|Mean Difference (Final Values)|0.06||||0.606||95.0|-0.17|0.29||P-value for test of difference between treatments.|ANCOVA|Regimen, country and previous oral antidiabetic drug (OAD) use as factors and baseline HbA1c as covariate.||Equivalence analysis with a null hypothesis stating that there is a difference between Advanced and Basic treatment groups of more than 0.4%.||0.29|-0.17|0.606
71054492|NCT00537303|141612984|NON_INFERIORITY_OR_EQUIVALENCE|The two treatments are declared equivalent if the 95% Confidence Interval for the estimated difference in means between the two treatment groups is included in the interval from -0.4 to 0.4 for both the Full Analysis Set and the Per Protocol set.|Mean Difference (Final Values)|0.03||||0.816||95.0|-0.21|0.26||P-value for test of difference between treatments.|ANCOVA|||Equivalence analysis with a null hypothesis stating that there is a difference between Advanced and Basic treatment groups of more than 0.4%.||0.26|-0.21|0.816
71054493|NCT04314648|141613018|SUPERIORITY||Odds Ratio (OR)|6.26|||<|0.001|TWO_SIDED|95.0|2.38|16.48|||Regression, Logistic|||||16.48|2.38|<.001
71054494|NCT04314648|141613019|SUPERIORITY||Odds Ratio, log|5.76|||<|0.01|TWO_SIDED|95.0|1.86|17.86|||Regression, Logistic|||||17.86|1.86|<.01
71054495|NCT04314648|141613020|SUPERIORITY||Odds Ratio (OR)|0.74||||0.64|TWO_SIDED|95.0|0.21|2.64|||Regression, Logistic||Main effects of the intervention on this outcome were compared between arms by fitting follow-up values to a logistic regression model, adjusted for baseline use.|||2.64|.21|.64
71054496|NCT04314648|141613021|SUPERIORITY||Odds Ratio (OR)|2.67||||0.35|TWO_SIDED|95.0|0.35|20.51|||Regression, Logistic||Main effects of the intervention on this outcome were compared between arms by fitting follow-up values to a logistic regression model, adjusted for baseline use.|||20.51|.35|.35
71054497|NCT04314648|141613022|SUPERIORITY||Mean Difference (Net)|-1.85|STANDARD_ERROR_OF_MEAN|2.32||0.43|TWO_SIDED||||||Regression, Linear||Main effects of the intervention on this outcome were compared between arms by fitting follow-up values to a linear regression model, adjusted for baseline use.|||||.43
71106637|NCT00806585|141719954|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.9||||0.543|TWO_SIDED|95.0|-4.0|2.1|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||2.1|-4.0|0.543
71054498|NCT04314648|141613023|SUPERIORITY||Mean Difference (Net)|2.35|STANDARD_ERROR_OF_MEAN|3.0||0.44|TWO_SIDED||||||Regression, Linear||Main effects of the intervention on this outcome were compared between arms by fitting follow-up values to a liner regression model, adjusted for baseline use.|||||.44
71054499|NCT04314648|141613024|SUPERIORITY||Odds Ratio (OR)|1.19||||0.77|TWO_SIDED|95.0|0.39|3.62|||Regression, Logistic|||||3.62|.39|.77
71054500|NCT00492024|141613034|SUPERIORITY_OR_OTHER|||||||0.189||95.0||||P-value is adjusted for study center; p-value applies to percentage of subjects with success (clinical cure)|Cochran-Mantel-Haenszel|Adjusted for study center||Null hypothesis is that the success rate for moxifloxacin = the success rate for placebo||||0.189
71054501|NCT00492024|141613039|SUPERIORITY_OR_OTHER|||||||0.075||95.0||||p-value adjusted for study center; p-value applies to percentage of subjects with success (clinical cure)|Cochran-Mantel-Haenszel|adjusted for study center||Null hypothesis is that the success rate for moxifloxacin = the success rate for placebo||||0.075
71054502|NCT00936897|141613070|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4|||<|0.0001|TWO_SIDED|95.0|1.0|1.8|||ANCOVA||Denosumab - Ibandronate|||1.8|1.0|<0.0001
71054503|NCT00936897|141613071|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71054504|NCT00936897|141613072|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2|||<|0.0001|TWO_SIDED|95.0|0.7|1.7|||ANCOVA||Denosumab - Ibandronate|||1.7|0.7|<0.0001
71054505|NCT00936897|141613073|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|||<|0.0001|TWO_SIDED|95.0|1.5|2.5|||ANCOVA||Denosumab - Ibandronate|||2.5|1.5|<0.0001
71054506|NCT03257865|141613079|SUPERIORITY||Treatment difference|-1.62|||=|0.1011|TWO_SIDED|95.0|-3.56|0.32|||mixed-effect model repeated measure||"Comparison between treatment groups was carried out using MMRM, with study center, treatment group, visit, and treatment group-by-visit interaction as factor and baseline-by-visit interaction as a covariate. An unstructured covariance was used."|||0.32|-3.56|=0.1011
71054507|NCT02792699|141613085|OTHER||Geometric LS Mean|152371.4|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
71054508|NCT02792699|141613085|OTHER||LS Geometric Mean|159236.0|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
71054509|NCT02792699|141613085|OTHER||LS Geometric Mean|172213.2|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
71054510|NCT02792699|141613085|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[US\]) for AUCinf was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9569|||||TWO_SIDED|90.0|0.887|1.0323||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0323|0.8870|
71054511|NCT02792699|141613085|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[EU\]) for AUCinf was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.8848|||||TWO_SIDED|90.0|0.8204|0.9542||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||0.9542|0.8204|
71079552|NCT04399538|141666518|SUPERIORITY||Difference in LS mean|-45.8||||0.0003||80.0|-55.86|-33.46|||ANCOVA|||Natural log-transformed individual relative change (RC) from baseline to Week 6 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline % liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale.||-33.46|-55.86|0.0003
71054512|NCT02792699|141613085|EQUIVALENCE|PK similarity between the test (rituximab \[US\]) and reference (rituximab \[EU\]) for AUCinf was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9246|||||TWO_SIDED|90.0|0.8575|0.997||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||0.9970|0.8575|
71054513|NCT02792699|141613086|OTHER||Geometric LS Mean|368.43|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
71054514|NCT02792699|141613086|OTHER||LS Geometric Mean|374.44|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
71054515|NCT02792699|141613086|OTHER||LS Geometric Mean|393.29|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
71054516|NCT02792699|141613086|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[US\]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.984|||||TWO_SIDED|90.0|0.9356|1.0348||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0348|0.9356|
71054517|NCT02792699|141613086|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[EU\]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9368|||||TWO_SIDED|90.0|0.8912|0.9848||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||0.9848|0.8912|
71054518|NCT02792699|141613086|EQUIVALENCE|PK similarity between the test (rituximab \[US\]) and reference (rituximab \[EU\]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9521|||||TWO_SIDED|90.0|0.9055|1.001||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0010|0.9055|
71054519|NCT02792699|141613087|OTHER||Geometric LS Mean|42203.8|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
71054520|NCT02792699|141613087|OTHER||LS Geometric Mean|43378.8|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
71054521|NCT02792699|141613087|OTHER||LS Geometric Mean|44925.3|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
71054522|NCT02792699|141613087|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[US\]) for AUC0-14day was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9729|||||TWO_SIDED|90.0|0.9174|1.0318||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0318|0.9174|
71054523|NCT02792699|141613087|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[EU\]) for AUC0-14day was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9394|||||TWO_SIDED|90.0|0.8863|0.9958||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||0.9958|0.8863|
71054524|NCT02792699|141613087|EQUIVALENCE|PK similarity between the test (rituximab \[US\]) and reference (rituximab \[EU\]) for AUC0-14day was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9656|||||TWO_SIDED|90.0|0.9104|1.024||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0240|0.9104|
71054525|NCT02792699|141613088|OTHER||Geometric LS Mean|149590.5|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
71054526|NCT02792699|141613088|OTHER||LS Geometric Mean|155778.7|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
71054527|NCT02792699|141613088|OTHER||LS Geometric Mean|166811.0|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
71054528|NCT02792699|141613088|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[US\]) for AUC0-12wk was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9603|||||TWO_SIDED|90.0|0.895|1.0303||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0303|0.8950|
71106638|NCT00806585|141719954|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.8||||0.246|TWO_SIDED|95.0|-4.9|1.3|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||1.3|-4.9|0.246
70932893|NCT04701203|141365870|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||For the primary efficacy endpoint, the Cochran-Mantel Haenszel test stratified by etiology of hypoparathyroidism (postsurgical or other) was used to compare the proportion of participants meeting the composite primary endpoint in the TransCon PTH versus placebo groups. Participants without week 26 albumin-adjusted serum calcium or with \>25% (ie, \>7 days) missing diary data of active vitamin D or elemental calcium during the 4 weeks before week 26 were considered non-responders.||||<0.0001
70932894|NCT04701203|141365871|SUPERIORITY||||||=|0.0038|||||||t-test, 2 sided|||ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.||||= 0.0038
71021646|NCT00830063|141550728|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.52|-0.19||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.19|-0.52|<0.001
71021647|NCT00830063|141550728|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.08||0.012|TWO_SIDED|95.0|-0.38|-0.05||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.05|-0.38|0.012
71021648|NCT00830063|141550728|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.021|TWO_SIDED|95.0|-0.36|-0.03||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.03|-0.36|0.021
71021649|NCT00661674|141550772|SUPERIORITY_OR_OTHER|||||||0.0001||||||p-value represents comparison between OOWS scores at T=180 and the baseline measurements at T=-30.|Friedman Test|||"Null Hypothesis: There will be no difference in OOWS scores when comparing treatment groups (Palonosetron \& Palonosetron + Hydroxyzine) with placebo.~Analysis of the data obtained in our prior study indicated that analysis of 10 individuals would provide 90% power to detect a treatment effect. Therefore, we examined the effect of three different pretreatments on naloxone-induced opiate withdrawal signs in 10 healthy individuals."||||0.0001
71021650|NCT00661674|141550773|SUPERIORITY_OR_OTHER|||||||0.2244||||||p-value represents comparison between SOWS scores at T=180 and the baseline measurements at T=-30.|Friedman Test|||"Null Hypothesis: There will be no difference in SOWS scores when comparing the 2 treatment groups (Palonosetron \& Palonosetron + Hydroxyzine) with placebo.~Analysis of the data obtained in our prior study indicated that analysis of 10 individuals would provide 90% power to detect a treatment effect. Therefore, we examined the effect of three different pretreatments on naloxone-induced opiate withdrawal signs in 10 healthy individuals."||||0.2244
71021651|NCT01872689|141550774|SUPERIORITY||Median Difference (Final Values)|0.98111|STANDARD_ERROR_OF_MEAN|1.31064||0.4555|TWO_SIDED|95.0|-1.61|3.57|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||3.57|-1.61|0.4555
71021652|NCT01872689|141550774|SUPERIORITY||Mean Difference (Final Values)|0.49998|STANDARD_ERROR_OF_MEAN|0.84946||0.5566|TWO_SIDED|95.0|-1.17|2.17|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||2.17|-1.17|0.5566
71021653|NCT01872689|141550775|SUPERIORITY||Median Difference (Final Values)|21.93023|STANDARD_ERROR_OF_MEAN|21.62248||0.3129|TWO_SIDED|95.0|-20.97|64.83|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||64.83|-20.97|0.3129
71021654|NCT01872689|141550775|SUPERIORITY||Mean Difference (Final Values)|-21.4127|STANDARD_ERROR_OF_MEAN|16.8016||0.2036|TWO_SIDED|95.0|-54.5|11.67|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||11.67|-54.50|0.2036
71021655|NCT01872689|141550777|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.4299|TWO_SIDED|95.0|0.44|1.41|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.41|0.44|0.4299
71106639|NCT00806585|141719954|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.4||||0.821|TWO_SIDED|95.0|-3.5|2.7|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||2.7|-3.5|0.821
71106640|NCT00806585|141719954|SUPERIORITY_OR_OTHER||Difference in least squares means|-7.0|||<|0.001|TWO_SIDED|95.0|-10.7|-3.3|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||-3.3|-10.7|<0.001
71106641|NCT00806585|141719954|SUPERIORITY_OR_OTHER||Difference in least squares means|6.1||||0.001|TWO_SIDED|95.0|2.4|9.8|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||9.8|2.4|0.001
71021656|NCT01872689|141550777|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.3751|TWO_SIDED|95.0|0.56|1.24|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.24|0.56|0.3751
71021657|NCT01872689|141550778|SUPERIORITY||Median Difference (Final Values)|0.54171|STANDARD_ERROR_OF_MEAN|1.05201||0.6075|TWO_SIDED|95.0|-1.54|2.62|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||2.62|-1.54|0.6075
70932895|NCT04701203|141365872|SUPERIORITY||||||=|0.0055|||||||t-test, 2 sided|||ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.||||= 0.0055
71054529|NCT02792699|141613088|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[EU\]) for AUC0-12wk was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.8968|||||TWO_SIDED|90.0|0.8363|0.9616||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||0.9616|0.8363|
71054530|NCT02792699|141613088|EQUIVALENCE|PK similarity between the test (rituximab \[US\]) and reference (rituximab \[EU\]) for AUC0-12wk was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9339|||||TWO_SIDED|90.0|0.8707|1.0016||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0016|0.8707|
71054531|NCT02792699|141613089|OTHER||Geometric LS Mean|304.04|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
71054532|NCT02792699|141613089|OTHER||LS Geometric Mean|305.8|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
71054533|NCT02792699|141613089|OTHER||LS Geometric Mean|320.87|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
71054534|NCT02792699|141613089|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[US\]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9942|||||TWO_SIDED|90.0|0.9461|1.0448||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0448|0.9461|
71106642|NCT00806585|141719954|SUPERIORITY_OR_OTHER||Difference in least squares means|5.2||||0.006|TWO_SIDED|95.0|1.5|8.9|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||8.9|1.5|0.006
70932896|NCT04701203|141365873|SUPERIORITY||||||=|0.0046|||||||t-test, 2 sided|||ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.||||= 0.0046
71054535|NCT02792699|141613089|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[EU\]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9475|||||TWO_SIDED|90.0|0.9021|0.9953||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||0.9953|0.9021|
71054536|NCT02792699|141613089|EQUIVALENCE|PK similarity between the test (rituximab \[US\]) and reference (rituximab \[EU\]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9531|||||TWO_SIDED|90.0|0.907|1.0015||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0015|0.9070|
71054537|NCT02792699|141613098|EQUIVALENCE|Clinical equivalence was tested by comparing the 2-sided 90% CI of the change from baseline at week 24 of DAS28-CRP between ABP 798 and rituximab with an equivalence margin of (-0.6, 0.6).|LS Mean Difference|0.02|||||TWO_SIDED|90.0|-0.225|0.264||||||If PK similarity was established between rituximab (US) and rituximab (EU), the 2 rituximab arms were to be combined into a single reference group for the primary assessment of clinical equivalence of DAS28-CRP change from baseline at week 24 using a repeated measures analysis with DAS28-CRP change from baseline as the response and the stratification variables, visit, treatment, treatment-by-visit interaction and baseline DAS28-CRP as predictors, and unstructured covariance matrix in the model.||0.264|-0.225|
71054538|NCT02792699|141613098|OTHER||LS Mean Difference|-0.07|||||TWO_SIDED|90.0|-0.353|0.213||||||||0.213|-0.353|
71054539|NCT02792699|141613098|OTHER||LS Mean Difference|0.11|||||TWO_SIDED|90.0|-0.171|0.392||||||||0.392|-0.171|
71054540|NCT02792699|141613099|OTHER||LS Mean Difference|0.064|||||TWO_SIDED|90.0|-0.203|0.33||||||Analysis of change from baseline at week 8, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.330|-0.203|
71054541|NCT02792699|141613099|OTHER||LS Mean Difference|-0.147|||||TWO_SIDED|90.0|-0.411|0.117||||||Analysis of change from baseline at week 8, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.117|-0.411|
71054542|NCT02792699|141613099|OTHER||LS Mean Difference|0.502|||||TWO_SIDED|90.0|0.233|0.772||||||Analysis of change from baseline at week 12, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.772|0.233|
71106643|NCT00806585|141719954|SUPERIORITY_OR_OTHER||Difference in least squares means|6.7|||<|0.001|TWO_SIDED|95.0|3.0|10.4|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||10.4|3.0|<0.001
70932897|NCT04701203|141365874|SUPERIORITY||||||=|0.0061|||||||t-test, 2 sided|||ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.||||= 0.0061
71106644|NCT00806585|141719955|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.4||||0.684|TWO_SIDED|95.0|-8.3|5.5|||ANCOVA|Fixed effects for treatment baseline, stratification, time, interaction of time by stratification and treatments factors and a random subject effect||||5.5|-8.3|0.684
71106645|NCT00806585|141719955|SUPERIORITY_OR_OTHER||Difference in least squares means|1.8||||0.597|TWO_SIDED|95.0|-5.0|8.7|||ANCOVA|Fixed effects for treatment baseline, stratification, time, interaction of time by stratification and treatments factors and a random subject effect||||8.7|-5.0|0.597
71106646|NCT00806585|141719955|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.9||||0.793|TWO_SIDED|95.0|-7.6|5.8|||ANCOVA|Fixed effects for treatment baseline, stratification, time, interaction of time by stratification and treatments factors and a random subject effect||||5.8|-7.6|0.793
71106647|NCT00806585|141719955|SUPERIORITY_OR_OTHER||Difference in least squares means|0.8||||0.854|TWO_SIDED|95.0|-7.6|9.2|||ANCOVA|Fixed effects for treatment baseline, stratification, time, interaction of time by stratification and treatments factors and a random subject effect||||9.2|-7.6|0.854
71106648|NCT00806585|141719956|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.9||||0.006|TWO_SIDED|95.0|-3.2|-0.5|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||-0.5|-3.2|0.006
71106649|NCT00806585|141719956|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.0||||0.004|TWO_SIDED|95.0|-3.3|-0.6|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||-0.6|-3.3|0.004
71106650|NCT00806585|141719956|SUPERIORITY_OR_OTHER||Diffference in least squares means|-1.3||||0.066|TWO_SIDED|95.0|-2.6|0.1|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||0.1|-2.6|0.066
71106651|NCT00806585|141719956|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.2||||0.008|TWO_SIDED|95.0|-3.7|-0.6|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||-0.6|-3.7|0.008
71106652|NCT00806585|141719957|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.18||||0.152|TWO_SIDED|95.0|-0.44|0.07|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||0.07|-0.44|0.152
71106653|NCT00806585|141719957|SUPERIORITY_OR_OTHER||Difference in least sqaures means|-0.28||||0.035|TWO_SIDED|95.0|-0.54|-0.02|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||-0.02|-0.54|0.035
70932898|NCT04701203|141365875|SUPERIORITY||||||=|0.0347|||||||t-test, 2 sided|||ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.||||= 0.0347
70932899|NCT06140290|141365876|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the reference treatment, while Etrasimod 2mg (Treatment G) without practice session was the test treatment.|Ratio of Adjusted Geometric Means|108.32|||||TWO_SIDED|90.0|101.2|115.94|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using a mixed effect model, with treatment as a fixed effect and participant as a random effect.||115.94|101.20|
71106654|NCT00806585|141719957|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.22||||0.095|TWO_SIDED|95.0|-0.48|0.04|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||0.04|-0.48|0.095
71106655|NCT00806585|141719957|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.32||||0.045|TWO_SIDED|95.0|-0.63|-0.01|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||-0.01|-0.63|0.045
71106656|NCT00474903|141719958|SUPERIORITY_OR_OTHER|||||||0.0955|||||||Wilcoxon (Mann-Whitney)|||||||0.0955
71106657|NCT00474903|141719958|SUPERIORITY_OR_OTHER|||||||0.0204|||||||Wilcoxon (Mann-Whitney)|||||||0.0204
71106658|NCT03435380|141719972|SUPERIORITY||Risk Ratio (RR)|2.37||||0.019|TWO_SIDED|95.0|1.11|5.07|||Mantel Haenszel|Stratified by age at consent (25-39 vs \>=40), diagnosis (Hodgkin lymphoma vs other) and previous breast imaging exam (either mammogram or breast MRI).||||5.07|1.11|0.019
71106659|NCT03435380|141719972|SUPERIORITY||Risk Ratio (RR)|1.96||||0.092|TWO_SIDED|95.0|0.87|4.38|||Mantel Haenszel|Stratified by age at consent (25-39 vs \>=40), diagnosis (Hodgkin lymphoma vs other) and previous breast imaging exam (either mammogram or breast MRI).||||4.38|0.87|0.092
71106660|NCT01103414|141719988|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.1|STANDARD_ERROR_OF_MEAN|6.77||0.1819|TWO_SIDED|95.0|-22.4|4.3|||ANCOVA|||||4.3|-22.4|0.1819
71106661|NCT01103414|141719988|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-18.4|STANDARD_ERROR_OF_MEAN|6.59||0.0057|TWO_SIDED|95.0|-31.4|-5.4|||ANCOVA|||||-5.4|-31.4|0.0057
71106662|NCT01103414|141719988|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.9|STANDARD_ERROR_OF_MEAN|6.8|<|0.0001|TWO_SIDED|95.0|-42.3|-15.6|||ANCOVA|||||-15.6|-42.3|<0.0001
71106663|NCT01103414|141719988|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-31.0|STANDARD_ERROR_OF_MEAN|6.5|<|0.0001|TWO_SIDED|95.0|-43.8|-18.2|||ANCOVA|||||-18.2|-43.8|<0.0001
71106664|NCT01103414|141719989|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39|STANDARD_ERROR_OF_MEAN|0.175||0.0273|TWO_SIDED|95.0|-0.73|-0.04|||ANCOVA|||||-0.04|-0.73|0.0273
71054543|NCT02792699|141613099|OTHER||LS Mean Difference|0.27|||||TWO_SIDED|90.0|0.0|0.539||||||Analysis of change from baseline at week 12, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.539|0.000|
71054544|NCT02792699|141613099|OTHER||LS Mean Difference|0.255|||||TWO_SIDED|90.0|-0.04|0.55||||||Analysis of change from baseline at week 40, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.550|-0.040|
71021658|NCT01872689|141550778|SUPERIORITY||Mean Difference (Final Values)|0.18203|STANDARD_ERROR_OF_MEAN|0.65206||0.7803|TWO_SIDED|95.0|-1.1|1.47|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||1.47|-1.10|0.7803
71021659|NCT01872689|141550780|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0972|TWO_SIDED|95.0|0.39|1.09|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.09|0.39|0.0972
71021660|NCT01872689|141550780|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9344|TWO_SIDED|95.0|0.72|1.42|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.42|0.72|0.9344
71021661|NCT01872689|141550781|SUPERIORITY||Median Difference (Final Values)|28.12302|STANDARD_ERROR_OF_MEAN|49.47253||0.5707|TWO_SIDED|95.0|-69.8|126.04|||Mixed Models Analysis||Mean Difference = Lebrikizumab - Placebo|Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||126.04|-69.80|0.5707
71021662|NCT01872689|141550781|SUPERIORITY||Mean Difference (Final Values)|21.72972|STANDARD_ERROR_OF_MEAN|31.68767||0.4934|TWO_SIDED|95.0|-40.65|84.11|||Mixed Models Analysis||Mean Difference = Lebrikizumab - Placebo|Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||84.11|-40.65|0.4934
71021663|NCT01872689|141550782|SUPERIORITY||Median Difference (Final Values)|-2.10204|STANDARD_ERROR_OF_MEAN|2.41325||0.3854|TWO_SIDED|95.0|-6.88|2.68|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||2.68|-6.88|0.3854
71021664|NCT01872689|141550782|SUPERIORITY||Mean Difference (Final Values)|-0.16313|STANDARD_ERROR_OF_MEAN|1.37698||0.9057|TWO_SIDED|95.0|-2.87|2.55|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||2.55|-2.87|0.9057
71021665|NCT01872689|141550784|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.4433|TWO_SIDED|95.0|0.54|1.31|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.31|0.54|0.4433
71021666|NCT01872689|141550786|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.9366|TWO_SIDED|95.0|0.21|5.3|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||5.30|0.21|0.9366
71021667|NCT01872689|141550786|SUPERIORITY||Hazard Ratio (HR)|0.45||||0.1346|TWO_SIDED|95.0|0.16|1.31|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.31|0.16|0.1346
71021668|NCT01872689|141550788|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.6815|TWO_SIDED|95.0|0.52|1.54|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.54|0.52|0.6815
71021669|NCT01872689|141550790|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.5685|TWO_SIDED|95.0|0.23|2.26|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||2.26|0.23|0.5685
71021670|NCT01872689|141550790|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.1976|TWO_SIDED|95.0|0.37|1.23|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.23|0.37|0.1976
71021671|NCT03944707|141550902|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_DEVIATION|0.0698||0.6643|TWO_SIDED|80.0|-0.06|0.119||Probability LOU064 better than placebo|Bayesian model for repeated measures||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|||0.119|-0.060|0.6643
71021672|NCT03944707|141550906|SUPERIORITY||Median Difference (Net)|-0.09|STANDARD_DEVIATION|0.21||0.6609|TWO_SIDED|80.0|-0.35|0.18||Probability LOU064 better than placebo|Bayesian model for repeated measures||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|||0.18|-0.35|0.6609
71021673|NCT03944707|141550907|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_DEVIATION|7.13||0.5107|TWO_SIDED|80.0|-9.0|9.1||Probability LOU064 better than placebo|Bayesian model for repeated measures||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|Change from baseline in mean morning PEF||9.1|-9.0|0.5107
71021674|NCT03944707|141550907|SUPERIORITY||Mean Difference (Net)|-3.4|STANDARD_DEVIATION|9.15||0.3611|TWO_SIDED|80.0|-15.2|8.1||Probability LOU064 better than placebo|Bayesian model for repeated measures||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|Change from baseline in mean evening PEF||8.1|-15.2|0.3611
71054545|NCT02792699|141613099|OTHER||LS Mean Difference|0.16|||||TWO_SIDED|90.0|-0.135|0.455||||||Analysis of change from baseline at week 40, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.455|-0.135|
71054546|NCT02792699|141613099|OTHER||LS Mean Difference|0.262|||||TWO_SIDED|90.0|-0.04|0.564||||||Analysis of change from baseline at week 48, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.564|-0.040|
71106665|NCT01103414|141719989|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.79|STANDARD_ERROR_OF_MEAN|0.171|<|0.0001|TWO_SIDED|95.0|-1.13|-0.45|||ANCOVA|||||-0.45|-1.13|<0.0001
71106666|NCT01103414|141719989|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.86|STANDARD_ERROR_OF_MEAN|0.176|<|0.0001|TWO_SIDED|95.0|-1.21|-0.52|||ANCOVA|||||-0.52|-1.21|<0.0001
71106667|NCT01103414|141719989|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.98|STANDARD_ERROR_OF_MEAN|0.169|<|0.0001|TWO_SIDED|95.0|-1.32|-0.65|||ANCOVA|||||-0.65|-1.32|<0.0001
71021675|NCT03944707|141550908|SUPERIORITY||Mean Difference (Net)|-0.133|STANDARD_DEVIATION|0.1588||0.8022|TWO_SIDED|80.0|-0.336|0.071||Probability LOU064 better than placebo|Bayesian model||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|||0.071|-0.336|0.8022
71021676|NCT03944707|141550909|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_DEVIATION|0.1573||0.6312|TWO_SIDED|80.0|-0.251|0.149||Probability LOU064 better than placebo|Bayesian model for repeated measures||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|Change from baseline in daytime asthma symptom score||0.149|-0.251|0.6312
71021677|NCT03944707|141550909|SUPERIORITY||Mean Difference (Net)|0.075|STANDARD_DEVIATION|0.0819||0.1752|TWO_SIDED|80.0|-0.028|0.18||Probability LOU064 better than placebo|Bayesian model for repeated measures||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|Change from baseline in nighttime asthma symptom score||0.180|-0.028|0.1752
71054547|NCT02792699|141613099|OTHER||LS Mean Difference|0.08|||||TWO_SIDED|90.0|-0.216|0.376||||||Analysis of change from baseline at week 48, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.376|-0.216|
71054548|NCT02792699|141613100|OTHER||Risk Ratio (RR)|0.9339|||||TWO_SIDED|90.0|0.7696|1.1332||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.1332|0.7696|
71054549|NCT02792699|141613100|OTHER||Risk Difference (RD)|-0.036|||||TWO_SIDED|90.0|-0.1495|0.0775||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0775|-0.1495|
71054550|NCT02792699|141613100|OTHER||Risk Ratio (RR)|1.0392|||||TWO_SIDED|90.0|0.8436|1.2801||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.2801|0.8436|
71054551|NCT02792699|141613100|OTHER||Risk Difference (RD)|0.0246|||||TWO_SIDED|90.0|-0.091|0.1402||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1402|-0.0910|
71106668|NCT02319486|141720003|SUPERIORITY_OR_OTHER||Probability of Event-Free Survival ，pEFS|0.32||||0.034|TWO_SIDED|||||stage 2 vs stage 3|pEFS||over all pEFS|||||0.034
71106669|NCT02493764|141720012|NON_INFERIORITY|Non-inferiority was declared when the upper bound of the 2-sided 95% confidence interval (CI) for the difference in mortality (IMI/REL minus PIP/TAZ) was \< 10 percentage points.|Adjusted difference in ACM|-5.3|||<|0.001|TWO_SIDED|95.0|-11.9|1.2|||t-test, 1 sided|A one-sided alpha level of 0.025 was used to declare significance.|Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in all-cause mortality||1.2|-11.9|<0.001
71021678|NCT01965535|141550934|SUPERIORITY_OR_OTHER||difference in proportions|1.4|||||TWO_SIDED|95.0|-5.9|8.6|||||The 2-sided 95% confidence interval (CI) on the difference in SVR12 rates between the 2 treatment groups was constructed based on stratum-adjusted Mantel-Haenszel (MH) proportions.|A sample size of 75 subjects in each treatment group would provide 80% power to detect a difference of 15% in SVR12 rates (80% vs 95%) between the 2 treatment groups.||8.6|-5.9|
71054552|NCT02792699|141613100|OTHER||Risk Ratio (RR)|0.878|||||TWO_SIDED|90.0|0.7573|1.0179||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0179|0.7573|
71054553|NCT02792699|141613100|OTHER||Risk Difference (RD)|-0.0794|||||TWO_SIDED|90.0|-0.1834|0.0247||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0247|-0.1834|
71054554|NCT02792699|141613100|OTHER||Risk Ratio (RR)|1.0426|||||TWO_SIDED|90.0|0.877|1.2394||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.2394|0.8770|
71054555|NCT02792699|141613100|OTHER||Risk Difference (RD)|0.0348|||||TWO_SIDED|90.0|-0.0758|0.1454||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1454|-0.0758|
71054556|NCT02792699|141613100|OTHER||Risk Ratio (RR)|1.0102|||||TWO_SIDED|90.0|0.8743|1.1671||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.1671|0.8743|
71054557|NCT02792699|141613100|OTHER||Risk Difference (RD)|0.0199|||||TWO_SIDED|90.0|-0.0835|0.1234||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1234|-0.0835|
71054558|NCT02792699|141613100|OTHER||Risk Ratio (RR)|1.0793|||||TWO_SIDED|90.0|0.9244|1.2601||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.2601|0.9244|
70932900|NCT06140290|141365877|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the reference treatment, while Etrasimod 2mg (Treatment G) without practice session was the test treatment.|Ratio of Adjusted Geometric Means|120.41|||||TWO_SIDED|90.0|108.02|134.22|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using a mixed effect model, with treatment as a fixed effect and participant as a random effect.||134.22|108.02|
70941640|NCT04748445|141383934|OTHER||Slope|2.673|STANDARD_ERROR_OF_MEAN|5.892|<|0.0001|TWO_SIDED|90.0|1.697|3.65|||Mixed Models Analysis|||EE\_MFCC std 09 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and estimated value it was 10\^-2. For dispersion value it was 10\^-3).||3.650|1.697|<.0001
71021679|NCT00986154|141550966|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed to accumulate approximately 220 Overall primary efficacy events in the mITT (modified Intent to Treat) Analysis Set. Assuming equal efficacy (Hazard Ratio = 1.00), a total of 220 events gave a power of 85% to demonstrate that (LMW) heparin/edoxaban was non-inferior to the comparator, considering a relative non-inferiority margin of 1.5 (two sided α=0.05).|Hazard Ratio (HR)|0.89|||<|0.0001|TWO_SIDED|95.0|0.703|1.128|||Regression, Cox||Time to 1st event analyzed by Cox proportional hazards with terms treatment group, randomization stratification factors: Presenting Diagnosis (PE with/without DVT, DVT only); Baseline risk factors (temp factors; all others); Need for reduced dose|(LMW) heparin/edoxaban will be non-inferior to (LMW) heparin/warfarin in preventing recurrence of acute, symptomatic VTE following initial index event. (LMW) Heparin/edoxaban was considered non-inferior to the standard therapy (\[LMW\] heparin/warfarin) if the upper limit of the two-sided 95% confidence interval (CI) for the Hazard Ratio (\[LMW\] heparin/edoxaban to standard therapy) was less than 1.5. Events included in Overall study period if occurred on or after randomization date up to Day 365.||1.128|.703|<0.0001
71021680|NCT00986154|141550967|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9933|TWO_SIDED|95.0|0.832|1.2|||Regression, Cox||Time to 1st event analyzed by Cox proportional hazards with terms treatment group, randomization stratification factors: Presenting Diagnosis (PE with/without DVT, DVT only); Baseline risk factors (temp factors; all others); Need for reduced dose.|||1.200|.832|.9933
71021681|NCT00986154|141550968|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.004|TWO_SIDED|95.0|0.705|0.936|||Regression, Cox||Time to 1st event analyzed by Cox proportional hazards with terms treatment group, randomization stratification factors: Presenting Diagnosis (PE with/without DVT, DVT only); Baseline risk factors (temp factors; all others); Need for reduced dose|"Safety Analysis set includes all randomized subjects who received at least one dose of study drug.~Null hypothesis (LMW) heparin/edoxaban will be comparable to (LMW) heparin/warfarin in preventing recurrence of major or clinically relevant non-major bleeding."||.936|.705|.0040
71021682|NCT00068445|141550976|SUPERIORITY|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||||||0.56
71021683|NCT00068445|141550977|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
71021684|NCT00068445|141550978|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
71021685|NCT00068445|141550979|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||||||0.34
71021686|NCT00068445|141550980|SUPERIORITY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
71021687|NCT00068445|141550981|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
71021688|NCT00068445|141550982|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
71021689|NCT00068445|141550983|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
71021690|NCT00068445|141550984|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
71021691|NCT00068445|141550985|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
71021692|NCT01493531|141550986|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.32|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|0.23|0.41|||Cochran-Mantel-Haenszel|||||0.41|0.23|<0.0001
71021693|NCT01493531|141550986|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.43|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|0.34|0.52|||Cochran-Mantel-Haenszel|||||0.52|0.34|<0.0001
71021694|NCT01493531|141550987|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88||||0.5716|TWO_SIDED|95.0|0.57|1.37|||Negative Binomial Regression|||||1.37|0.57|0.5716
71021695|NCT01493531|141550987|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.93||||0.7454|TWO_SIDED|95.0|0.6|1.45|||Negative Binomial Regression|||||1.45|0.60|0.7454
71021696|NCT01493531|141550988|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.02||||0.8466|TWO_SIDED|95.0|-0.24|0.2|||Cochran-Mantel-Haenszel|||||0.2|-0.24|0.8466
71021697|NCT01493531|141550988|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.06||||0.6301|TWO_SIDED|95.0|-0.29|0.17|||Cochran-Mantel-Haenszel|||||0.17|-0.29|0.6301
71021698|NCT01946282|141550989|EQUIVALENCE|Assuming a FIT return rate of 29% for the outreach only group at an a=0.05, we estimated more than 90% power to detect an absolute difference greater than 5% when using a chi-square test of proportions to compare patients who received any incentive ($5 or $10) compared with patients who received outreach only.||||||0.59|||||||Chi-squared|||||||0.59
71021699|NCT01946282|141550989|EQUIVALENCE|Assuming a FIT return rate of 29% for the outreach only group at an a=0.05, we estimated more than 90% power to detect an absolute difference greater than 5% when using a chi-square test of proportions to compare patients who received any incentive ($5 or $10) compared with patients who received outreach only.||||||0.75|||||||Chi-squared|||||||.75
71021700|NCT01946282|141550989|EQUIVALENCE|Assuming a FIT return rate of 29% for the outreach only group at an a=0.05, we estimated more than 90% power to detect an absolute difference greater than 5% when using a chi-square test of proportions to compare patients who received any incentive ($5 or $10) compared with patients who received outreach only.||||||0.08|||||||Chi-squared|||||||.080
71021701|NCT01946282|141550990|EQUIVALENCE|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.||||||0.07|||||||Chi-squared|||||||0.070
71021702|NCT01946282|141550990|EQUIVALENCE|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.||||||0.8|||||||Chi-squared|||||||0.80
71021703|NCT01946282|141550990|EQUIVALENCE|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.||||||0.6|||||||Chi-squared|||||||0.60
70941641|NCT04748445|141383934|OTHER||Slope|0.01394|STANDARD_ERROR_OF_MEAN|5.642||0.0148|TWO_SIDED|90.0|0.004595|0.02329|||Mixed Models Analysis|||EE\_MFCC std 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.02329|0.004595|0.0148
70941642|NCT04748445|141383934|OTHER||Slope|0.01547|STANDARD_ERROR_OF_MEAN|6.666||0.0219|TWO_SIDED|90.0|0.004425|0.02652|||Mixed Models Analysis|||EE\_MFCC std 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.02652|0.004425|0.0219
71021704|NCT01946282|141550990|EQUIVALENCE|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.||||||0.31|||||||Chi-squared|||||||0.31
71021705|NCT01946282|141550990|EQUIVALENCE|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.||||||0.82|||||||Chi-squared|||||||0.82
71021706|NCT01946282|141550990|EQUIVALENCE|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.||||||0.033|||||||Chi-squared|||||||0.033
71054559|NCT02792699|141613100|OTHER||Risk Difference (RD)|0.0561|||||TWO_SIDED|90.0|-0.0493|0.1615||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1615|-0.0493|
71054560|NCT02792699|141613100|OTHER||Risk Ratio (RR)|0.8848|||||TWO_SIDED|90.0|0.7759|1.0091||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0091|0.7759|
71054561|NCT02792699|141613100|OTHER||Risk Difference (RD)|-0.0776|||||TWO_SIDED|90.0|-0.1789|0.0237||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0237|-0.1789|
71054562|NCT02792699|141613100|OTHER||Risk Ratio (RR)|0.9982|||||TWO_SIDED|90.0|0.8585|1.1605||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.1605|0.8585|
71054563|NCT02792699|141613100|OTHER||Risk Difference (RD)|0.0008|||||TWO_SIDED|90.0|-0.1038|0.1054||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1054|-0.1038|
71054564|NCT02792699|141613100|OTHER||Risk Ratio (RR)|0.7862|||||TWO_SIDED|90.0|0.6722|0.9196||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.9196|0.6722|
71054565|NCT02792699|141613100|OTHER||Risk Difference (RD)|-0.2004|||||TWO_SIDED|90.0|-0.3066|-0.0941||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||-0.0941|-0.3066|
71054566|NCT02792699|141613100|OTHER||Risk Ratio (RR)|0.8804|||||TWO_SIDED|90.0|0.7587|1.0215||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0215|0.7587|
71054567|NCT02792699|141613100|OTHER||Risk Difference (RD)|-0.1037|||||TWO_SIDED|90.0|-0.2066|-0.0007||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||-0.0007|-0.2066|
71054568|NCT02792699|141613101|OTHER||Risk Ratio (RR)|0.9256|||||TWO_SIDED|90.0|0.64|1.3388||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.3388|0.6400|
71054569|NCT02792699|141613101|OTHER||Risk Difference (RD)|-0.0181|||||TWO_SIDED|90.0|-0.1209|0.0847||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0847|-0.1209|
71054570|NCT02792699|141613101|OTHER||Risk Ratio (RR)|1.0868|||||TWO_SIDED|90.0|0.7328|1.6119||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.6119|0.7328|
71054571|NCT02792699|141613101|OTHER||Risk Difference (RD)|0.0201|||||TWO_SIDED|90.0|-0.0803|0.1205||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1205|-0.0803|
70932901|NCT06140290|141365878|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the reference treatment, while Etrasimod 2mg (Treatment G) without practice session was the test treatment.|Ratio of Adjusted Geometric Means|115.29|||||TWO_SIDED|90.0|105.17|126.38|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using a mixed effect model, with treatment as a fixed effect and participant as a random effect.||126.38|105.17|
70932902|NCT06140290|141365879|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the reference treatment, while Etrasimod 2mg (Treatment G) without practice session was the test treatment.|Ratio of Adjusted Geometric Means|106.75|||||TWO_SIDED|90.0|99.33|114.73|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using a mixed effect model, with treatment as a fixed effect and participant as a random effect.||114.73|99.33|
70941643|NCT04748445|141383934|OTHER||Slope|1.118|STANDARD_ERROR_OF_MEAN|6.122||0.0703|TWO_SIDED|90.0|1.032|2.132|||Mixed Models Analysis|||EE\_MFCC std 12 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and estimated value it was 10\^-2. For lower limit and dispersion value it was 10\^-3).||2.132|1.032|0.0703
71021707|NCT01946282|141550990|EQUIVALENCE|We estimated needing 545 observations per incentive group to achieve power necessary to detect at least a 10% absolute difference in FIT return rate between patients who received the $5 incentive versus patients who received the $10 incentive, with assumed rates of 45% in the $5 incentive group and 53% in the $10 incentive group, a=0.05, and power=90%.||||||0.033|||||||Chi-squared|||||||0.033
71021708|NCT01946282|141550990|EQUIVALENCE||||||>|0.99|||||||Chi-squared|||||||>0.99
71021709|NCT01946282|141550990|EQUIVALENCE|||||||0.184|||||||Chi-squared|||||||0.184
71021710|NCT01205529|141551000|SUPERIORITY||Odds Ratio (OR)|0.0||||1|TWO_SIDED||||||Regression, Logistic||0 participants with rare SCN5A non-synonymous variants met the primary outcome for ST-segment elevation.||Given the very small number of outcomes (N=4) and the small number of participants with the primary determinant (N=2), a Fisher's Exact Test is the appropriate test and it yields a P-value=1.000.|||1.0
71021711|NCT02059187|141551013|NON_INFERIORITY_OR_EQUIVALENCE|MK-1293 was to be considered non-inferior to Lantus in type 2 diabetes mellitus (T2DM) if the upper bound of the two-sided 95% confidence interval (CI) for the between-treatment difference (MK-1293 minus Lantus) in least-squares (LS) means was below 0.4% based on a cLDA model.|Difference in least squares means|0.03|||||TWO_SIDED|95.0|-0.12|0.18||||||||0.18|-0.12|
71021712|NCT02059187|141551014|SUPERIORITY_OR_OTHER||Difference in percentage|5.7|||||TWO_SIDED|95.0|-2.3|13.7||||||||13.7|-2.3|
71021713|NCT02059187|141551016|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-8.5|8.5||||||||8.5|-8.5|
71021714|NCT02059187|141551017|SUPERIORITY_OR_OTHER||Difference in percent|6.8|||||TWO_SIDED|95.0|-0.6|14.2||||||||14.2|-0.6|
71021715|NCT02059187|141551018|SUPERIORITY_OR_OTHER||Difference in LS means|1.4|||||TWO_SIDED|95.0|-2.2|4.9||||||||4.9|-2.2|
71021716|NCT02059187|141551019|SUPERIORITY_OR_OTHER||Dofference in LS means|0.01|||||TWO_SIDED|95.0|-0.02|0.05||||||||0.05|-0.02|
71021717|NCT02059187|141551020|SUPERIORITY_OR_OTHER||Difference in LS means|3.5|||||TWO_SIDED|95.0|-3.7|10.7||||||||10.7|-3.7|
71021718|NCT02059187|141551021|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.4|||||TWO_SIDED|95.0|-11.3|4.4||||||||4.4|-11.3|
71021719|NCT02059187|141551022|SUPERIORITY_OR_OTHER||Adjusted difference in percent|2.8|||||TWO_SIDED|95.0|-6.1|11.6|||||Calculated via Miettinen and Nurminen method, stratified by prior insulin status.|||11.6|-6.1|
71021720|NCT02059187|141551023|SUPERIORITY_OR_OTHER||Adjusted difference in percent|-0.9|||||TWO_SIDED|95.0|-8.3|6.5|||||Calculated via Miettinen and Nurminen method, stratified by prior insulin status.|||6.5|-8.3|
71021721|NCT03070431|141551024|SUPERIORITY|It was assumed that radiotherapy with 5x4 Gy results in 6-month LPFS of 67% and an increase by 20% is clinically relevant when using 5x5 Gy. For comparison of 5x5 Gy and a historical control (5x4 Gy), it was assumed that it can be performed with a simple Pearson-Chi-Square test (2-sided significance level of 5%, power of 79%) if 40 patients treated with 5x5 Gy and 400 patients of the control group qualified for Propensity-Score adjusted comparison, assuming 6-month LPFS rates of 87% and 67%.|Risk Difference (RD)|20.0|||<|0.05|TWO_SIDED||||||Cochran-Mantel-Haenszel|||historical control group treated with 5 x 4 Gy|"In a prospective study, 6-month LPFS rates were 86% after longer-course (mainly 3Gyx10) and 67% after short-course radiotherapy (mainly 4Gyx5) \[Rades D, et al., Int J Radiat Oncol Biol Phys 2009;73:228-34.\]. For sample size calculations, it was assumed that conventional radiotherapy with 4Gyx5 results in 6-month LPFS of 67% and that an increase by 20% is clinically relevant and realistic with 5Gyx5. A sample size of 40 eligible patients was required for the phase 2 trial assuming that that 6-month LPFS would be 87% and estimated with a precision of +/-20% expressed as the half length of the associated two-sided confidence interval (95%), and power of \>=80%.~For comparison of phase 2 cohort and historical control group, it was assumed that this could be performed with a simple Pearson-Chi-Square test using a two-sided significance level of 5% (10%) and a power of 79% (86%) if 40 patients received 5Gyx5 and N=400 of the control group qualified for Propensity-Score adjusted comparison."|||<0.05
71021722|NCT01889862|141551034|SUPERIORITY||Mean Difference (Net)|-973.02|||<|0.0001|TWO_SIDED|95.0|-1204.19|-741.85||Based on Mixed-Effect Model Repeated Measure (MMRM) model with change from baseline as the response variable, and treatment, visit and treatment by visit interaction and baseline blood phe concentration as factors.|ANCOVA|||Change in blood Phe concentration during Part 2 in subjects previously exposed to BMN165 who self administer BMN165 20mg/day compared with those who self administer matching placebo.||-741.85|-1204.19|<0.0001
71021723|NCT01889862|141551034|SUPERIORITY||Mean Difference (Net)|-588.5|||<|0.0001|TWO_SIDED|95.0|-830.07|-346.94||Based on Mixed-Effect Model Repeated Measure (MMRM) model with change from baseline as the response variable, and treatment, visit and treatment by visit interaction and baseline blood phe concentration as factors.|ANCOVA|||Change in blood Phe concentration during Part 2 in subjects previously exposed to BMN165 who self administer BMN165 40mg/day compared with those who self administer matching placebo.||-346.94|-830.07|<0.0001
71021724|NCT00845026|141551040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.184||95.0||||No adjustments were made for multiplicity. All treatment comparisons were evaluated based on a two-sided significance level of 0.05.|Log Rank|||||||0.184
70941644|NCT04748445|141383934|OTHER||Slope|0.0116|STANDARD_ERROR_OF_MEAN|5.226||0.0282|TWO_SIDED|90.0|0.00294|0.02026|||Mixed Models Analysis|||EE\_MFCC std 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.02026|0.002940|0.0282
71054572|NCT02792699|141613101|OTHER||Risk Ratio (RR)|0.7095|||||TWO_SIDED|90.0|0.5387|0.9346||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.9346|0.5387|
71054573|NCT02792699|141613101|OTHER||Risk Difference (RD)|-0.1109|||||TWO_SIDED|90.0|-0.2231|0.0013||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0013|-0.2231|
71054574|NCT02792699|141613101|OTHER||Risk Ratio (RR)|1.0882|||||TWO_SIDED|90.0|0.7829|1.5127||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.5127|0.7829|
71054575|NCT02792699|141613101|OTHER||Risk Difference (RD)|0.0441|||||TWO_SIDED|90.0|-0.0626|0.1508||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1508|-0.0626|
71054576|NCT02792699|141613101|OTHER||Risk Ratio (RR)|0.9612|||||TWO_SIDED|90.0|0.7273|1.2705||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.2705|0.7273|
71054577|NCT02792699|141613101|OTHER||Risk Difference (RD)|0.002|||||TWO_SIDED|90.0|-0.1081|0.1122||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1122|-0.1081|
71054578|NCT02792699|141613101|OTHER||Risk Ratio (RR)|1.0029|||||TWO_SIDED|90.0|0.756|1.3305||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.3305|0.7560|
71054579|NCT02792699|141613101|OTHER||Risk Difference (RD)|0.0039|||||TWO_SIDED|90.0|-0.1056|0.1135||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1135|-0.1056|
71054580|NCT02792699|141613101|OTHER||Risk Ratio (RR)|0.8373|||||TWO_SIDED|90.0|0.6797|1.0316||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0316|0.6797|
71054581|NCT02792699|141613101|OTHER||Risk Difference (RD)|-0.0863|||||TWO_SIDED|90.0|-0.2029|0.0302||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0302|-0.2029|
71054582|NCT02792699|141613101|OTHER||Risk Ratio (RR)|1.1191|||||TWO_SIDED|90.0|0.878|1.4264||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.4264|0.8780|
71054583|NCT02792699|141613101|OTHER||Risk Difference (RD)|0.0288|||||TWO_SIDED|90.0|-0.0827|0.1402||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1402|-0.0827|
71054584|NCT02792699|141613101|OTHER||Risk Ratio (RR)|0.8376|||||TWO_SIDED|90.0|0.6807|1.0307||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0307|0.6807|
71054585|NCT02792699|141613101|OTHER||Risk Difference (RD)|-0.0781|||||TWO_SIDED|90.0|-0.2014|0.0452||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0452|-0.2014|
71054586|NCT02792699|141613101|OTHER||Risk Ratio (RR)|1.0548|||||TWO_SIDED|90.0|0.8351|1.3321||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.3321|0.8351|
71054587|NCT02792699|141613101|OTHER||Risk Difference (RD)|0.0141|||||TWO_SIDED|90.0|-0.1021|0.1303||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1303|-0.1021|
71054588|NCT02792699|141613102|OTHER||Risk Ratio (RR)|0.5926|||||TWO_SIDED|90.0|0.2818|1.2462||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.2462|0.2818|
71054589|NCT02792699|141613102|OTHER||Risk Difference (RD)|-0.0574|||||TWO_SIDED|90.0|-0.1285|0.0136||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0136|-0.1285|
71054590|NCT02792699|141613102|OTHER||Risk Ratio (RR)|0.7476|||||TWO_SIDED|90.0|0.3383|1.6519||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.6519|0.3383|
71106670|NCT02493764|141720013|NON_INFERIORITY|Non-inferiority was declared when the lower bound of the 2-sided 95% CI for the difference in FCR (IMI/REL minus PIP/TAZ) was \> 12.5 percentage points.|Adjusted difference in FCR|5.0|||<|0.001|TWO_SIDED|95.0|-3.2|13.2|||t-test, 1 sided|A one-sided alpha level of 0.025 was used to declare significance.|Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in FCR||13.2|-3.2|<0.001
71106671|NCT02493764|141720014|OTHER|Difference in % with AE vs PIP/TAZ|Difference in % with AE|-1.7|||||TWO_SIDED|95.0|-7.7|4.3||||||||4.3|-7.7|
71106672|NCT02493764|141720015|OTHER|Difference in % discontinuing vs PIP/TAZ|Difference in % discontinuing|-2.5|||||TWO_SIDED|95.0|-7.1|1.8||||||||1.8|-7.1|
71106673|NCT02493764|141720016|OTHER||Adjusted difference in ACM|-3.5|||||TWO_SIDED|95.0|-10.9|3.6|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in all-cause mortality||3.6|-10.9|
71106674|NCT02493764|141720017|NON_INFERIORITY|Non-inferiority was declared when the upper bound of the 2-sided 95% CI for the difference in mortality (IMI/REL minus PIP/TAZ) was ≥ 10 percentage points.|Adjusted difference in ACM|-4.6|||||TWO_SIDED|95.0|-11.0|1.7|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in all-cause mortality||1.7|-11.0|
71106675|NCT02493764|141720018|OTHER|Adjusted difference in ACM|Adjusted difference in ACM|-3.1|||||TWO_SIDED|95.0|-10.2|3.8|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in all-cause mortality||3.8|-10.2|
71106676|NCT02493764|141720019|OTHER|Difference in FCR|Adjusted difference in FCR|-1.7|||||TWO_SIDED|95.0|-11.3|7.8|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||7.8|-11.3|
71106677|NCT02493764|141720020|OTHER|Difference in FCR|Adjusted difference in FCR|-2.2|||||TWO_SIDED|95.0|-9.8|5.5|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||5.5|-9.8|
71106678|NCT02493764|141720021|OTHER|Difference in favorable clinical response|Adjusted difference in FCR|6.6|||||TWO_SIDED|95.0|-4.6|18.4|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||18.4|-4.6|
71106679|NCT02493764|141720022|OTHER|Difference in FCR|Adjusted difference in FCR|-0.4|||||TWO_SIDED|95.0|-8.1|7.4|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||7.4|-8.1|
71106680|NCT02493764|141720023|OTHER|Difference in FCR|Adjusted difference in FCR|-3.4|||||TWO_SIDED|95.0|-14.3|7.5|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||7.5|-14.3|
71106681|NCT02493764|141720024|OTHER|Difference in FCR|Adjusted difference in FCR|-3.7|||||TWO_SIDED|95.0|-13.6|6.4|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||6.4|-13.6|
71106682|NCT02493764|141720025|OTHER|Difference in FCR|Adjusted difference in FCR|3.5|||||TWO_SIDED|95.0|-4.6|11.6|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||11.6|-4.6|
71106683|NCT02493764|141720026|OTHER|Difference in FCR|Adjusted difference in FCR|0.5|||||TWO_SIDED|95.0|-6.3|7.4|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||7.4|-6.3|
71106684|NCT02493764|141720027|OTHER|Difference in FCR|Adjusted difference in FCR|3.4|||||TWO_SIDED|95.0|-7.1|14.2|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||14.2|-7.1|
71106685|NCT02493764|141720028|OTHER|Difference in FCR|Adjusted difference in FCR|4.4|||||TWO_SIDED|95.0|-3.1|12.0|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||12.0|-3.1|
71106686|NCT02493764|141720029|OTHER|Difference in FCR|Adjusted difference in FCR|1.1|||||TWO_SIDED|95.0|-7.2|9.4|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||9.4|-7.2|
71106687|NCT02493764|141720030|OTHER|Difference in FMR|Adjusted difference in FMR|9.7|||||TWO_SIDED|95.0|1.6|17.9|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable microbiological response||17.9|1.6|
71106688|NCT02493764|141720031|OTHER|Difference in FMR|Adjusted difference in FMR|6.2|||||TWO_SIDED|95.0|-2.7|15.0|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable microbiological response||15.0|-2.7|
71106689|NCT02493764|141720032|OTHER|Difference in FMR|Adjusted difference in FMR|2.5|||||TWO_SIDED|95.0|-5.5|11.0|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable microbiological response||11.0|-5.5|
71106690|NCT02493764|141720033|OTHER|Difference in FMR|Adjusted difference in FMR|4.7|||||TWO_SIDED|95.0|-4.0|14.1|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable microbiological response||14.1|-4.0|
71106691|NCT00859833|141720034|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation for equivalence: SD for adenosine = 0.59, SD for regadenoson = 0.92, true difference between groups = 0.19. With n=28, DOF = 46. Power for equivalence (with alpha = 0.05) = 0.98585.|Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|0.7||0.3617|TWO_SIDED|95.0|-0.6041|0.2241|||t-test, 2 sided|||Null hypothesis is that myocardial perfusion reserve (MPR) is not different when measured with adenosine or regadenoson in patients across a broad range of body sizes.||0.2241|-0.6041|0.3617
71106692|NCT03218917|141720035|SUPERIORITY||||||=|0.014||||||P-value is one-sided for superiority.|Stratified Log-rank test|Stratified by Pseudomonas aeruginosa (Pa) colonization status and maintenance antibiotic use at Baseline.||||||= 0.014
71106693|NCT03218917|141720035|SUPERIORITY||||||=|0.022||||||P-value is one-sided for superiority.|Stratified Log-rank test|Stratified by colonization status and maintenance antibiotic use at Baseline.||||||= 0.022
71106694|NCT01561976|141720046|OTHER||Ratio|108.94||||0.1413|TWO_SIDED|95.0|101.01|117.5|||ANOVA||Ratio= METLEAD ForteSR-Fed/METLEAD ForteSR-Fasting|||117.50|101.01|0.1413
71106695|NCT01561976|141720046|OTHER||Ratio|107.24||||0.1413|TWO_SIDED|95.0|99.37|115.73|||ANOVA||Ratio= METLEAD G2 Forte/METLEAD ForteSR-Fasting|||115.73|99.37|0.1413
71106696|NCT01561976|141720047|OTHER||Ratio|116.5||||0.0171|TWO_SIDED|95.0|106.91|126.95|||ANOVA||Ratio= METLEAD ForteSR-Fed/METLEAD ForteSR-Fasting|||126.95|106.91|0.0171
71106697|NCT01561976|141720047|OTHER||Ratio|107.24||||0.0171|TWO_SIDED|95.0|98.35|116.94|||ANOVA||Ratio= METLEAD G2 Forte/METLEAD ForteSR-Fasting|||116.94|98.35|0.0171
71054591|NCT02792699|141613102|OTHER||Risk Difference (RD)|-0.0327|||||TWO_SIDED|90.0|-0.0962|0.0308||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0308|-0.0962|
71054592|NCT02792699|141613102|OTHER||Risk Ratio (RR)|0.6346|||||TWO_SIDED|90.0|0.3704|1.0872||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0872|0.3704|
71054593|NCT02792699|141613102|OTHER||Risk Difference (RD)|-0.0569|||||TWO_SIDED|90.0|-0.1448|0.031||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0310|-0.1448|
71054594|NCT02792699|141613102|OTHER||Risk Ratio (RR)|0.7857|||||TWO_SIDED|90.0|0.445|1.3874||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.3874|0.4450|
71054595|NCT02792699|141613102|OTHER||Risk Difference (RD)|-0.0417|||||TWO_SIDED|90.0|-1237.0|0.0403||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0403|-1237|
71054596|NCT02792699|141613102|OTHER||Risk Ratio (RR)|0.9254|||||TWO_SIDED|90.0|0.5772|1.4838||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.4838|0.5772|
71054597|NCT02792699|141613102|OTHER||Risk Difference (RD)|0.0156|||||TWO_SIDED|90.0|-0.078|0.1092||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1092|-0.0780|
71054598|NCT02792699|141613102|OTHER||Risk Ratio (RR)|1.112|||||TWO_SIDED|90.0|0.6722|1.8398||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.8398|0.6722|
71054599|NCT02792699|141613102|OTHER||Risk Difference (RD)|0.0244|||||TWO_SIDED|90.0|-0.063|0.1119||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1119|-0.0630|
71054600|NCT02792699|141613102|OTHER||Risk Ratio (RR)|0.9798|||||TWO_SIDED|90.0|0.6675|1.4384||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.4384|0.6675|
71054601|NCT02792699|141613102|OTHER||Risk Difference (RD)|0.0375|||||TWO_SIDED|90.0|-0.0707|0.1456||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1456|-0.0707|
71054602|NCT02792699|141613102|OTHER||Risk Ratio (RR)|1.1831|||||TWO_SIDED|90.0|0.7833|1.787||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.7870|0.7833|
71054603|NCT02792699|141613102|OTHER||Risk Difference (RD)|0.0752|||||TWO_SIDED|90.0|-0.0297|0.1802||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1802|-0.0297|
71054604|NCT02792699|141613102|OTHER||Risk Ratio (RR)|0.7027|||||TWO_SIDED|90.0|0.493|1.0017||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0017|0.4930|
71054605|NCT02792699|141613102|OTHER||Risk Difference (RD)|-0.0908|||||TWO_SIDED|90.0|-0.211|0.0294||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0294|-0.2110|
71054606|NCT02792699|141613102|OTHER||Risk Ratio (RR)|1.1449|||||TWO_SIDED|90.0|0.7601|1.7246||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.7246|0.7601|
71054607|NCT02792699|141613102|OTHER||Risk Difference (RD)|0.0277|||||TWO_SIDED|90.0|-0.0804|0.1357||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1357|-0.0804|
71054608|NCT02792699|141613103|OTHER||LS Mean Difference|-1.999|||||TWO_SIDED|90.0|-7.673|3.675||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||3.675|-7.673|
71106698|NCT01561976|141720048|OTHER||Ratio|116.87||||0.0169|TWO_SIDED|95.0|107.07|127.57|||ANOVA||Ratio= METLEAD ForteSR-Fed/METLEAD ForteSR-Fasting|||127.57|107.07|0.0169
71106699|NCT01561976|141720048|OTHER||Ratio|107.38||||0.0169|TWO_SIDED|95.0|98.3|117.29|||ANOVA||Ratio= METLEAD G2 Forte/METLEAD ForteSR-Fasting|||117.29|98.30|0.0169
71117614|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
71054609|NCT02792699|141613103|OTHER||LS Mean Difference|0.544|||||TWO_SIDED|90.0|-5.185|6.274||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 8, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||6.274|-5.185|
71054610|NCT02792699|141613103|OTHER||LS Mean Difference|-8.224|||||TWO_SIDED|90.0|-14.102|-2.346||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||-2.346|-14.102|
71021725|NCT03276962|141551100|SUPERIORITY||Incremental vaccine efficacy|-21.0||||0.154|TWO_SIDED|95.0|-57.0|7.0|||Regression, Cox|The 95% Confidence Interval of the incremental vaccine efficacy estimates was calculated from Cox regression model.||To demonstrate the superiority of a 3-dose schedule of GSK Biologicals' malaria vaccine RTS,S/AS01E with a fractional third dose at Month 2 (Fx012-14-mFxD Group) compared to a standard schedule of RTS,S/AS01E with 3 full doses (R012-20 + R012-14 Group) in terms of vaccine efficacy against clinical malaria (primary case definition) over 12 months post-Dose 3.||7|-57|0.154
71021726|NCT02278952|141551159|OTHER|Generalized estimating equation-adjusted linear models||||||0.33|||||||GEE-adjusted models|||||||0.33
71021727|NCT02278952|141551160|OTHER|Generalized estimating equation-adjusted linear model|||||<|0.0001|||||||GEE-adjusted linear model|||||||< 0.0001
71021728|NCT02278952|141551161|OTHER|Generalized estimating equation-adjusted linear models||||||0.049|||||||GEE-adjusted linear models|||||||0.049
71021729|NCT02278952|141551162|OTHER|Generalized estimating equation-adjusted linear models||||||0.114|||||||GEE-adjusted linear models|||||||0.114
71021730|NCT02278952|141551163|OTHER|Generalized estimating equation-adjusted linear models||||||0.47|||||||GEE-adjusted linear models|||P-value of tacrolimus dose||||0.470
71021731|NCT02278952|141551163|OTHER|Generalized estimating equation-adjusted linear models||||||0.037|||||||GEE-adjusted linear models|||P-value of Prednisone dose||||0.037
71021732|NCT02278952|141551163|OTHER|Generalized-estimating equation-adjusted linear models||||||0.456|||||||GEE-adjusted linear models|||P-value of mycophenolate mofetil dose||||0.456
71021733|NCT01963676|141551168|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||There was no adjustment because we just performed one comparison|t-test, 2 sided|Difference from Day 5 to Baseline was compared between the sham and the tDCS group using an unpaired t-test. Degrees of freedom: df = 24||"The null hypothesis was that there is no difference between the changes in the AHRS score from baseline to 5 days between the groups:~H0: μ1 = μ2 μ1: mean(difference 5 days-baseline) for tDCS group (n=13) μ2: mean(difference 5 days-baseline) for sham group (n=13)"||||0.48
71021734|NCT01963676|141551169|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED|||||There was no adjustment because we just performed one comparison|t-test, 2 sided|Difference from 1 Month to Baseline was compared between the sham and the tDCS group using an unpaired t-test. Degrees of freedom: df = 24||"The null hypothesis was that there is no difference between the AHRS score changes from baseline to 1month between the groups:~H0: μ1 = μ2 μ1: mean(difference 1 month-baseline) for tDCS group (n=13) μ2: mean(difference 1 month-baseline) for sham group (n=13)"||||0.86
71021735|NCT01246973|141551170|SUPERIORITY_OR_OTHER|||||||0.6555|TWO_SIDED||||||F-test|||||||0.6555
71021736|NCT01246973|141551171|SUPERIORITY_OR_OTHER|||||||0.3504|TWO_SIDED||||||Chi-squared|||||||0.3504
71021737|NCT00766506|141551172|SUPERIORITY_OR_OTHER||Least square mean difference|-2.23|||<|0.001|TWO_SIDED|95.0|-2.55|-1.91|||ANCOVA|P-value was calculated from analysis of covariance (ANCOVA), with centre, surgery type and treatment included as covariates in the analysis.|Least square mean difference = Least square mean value for Fentanyl IONSYS group minus Least square mean value for Morphine IV PCA group|||-1.91|-2.55|<0.001
71021738|NCT00766506|141551173|SUPERIORITY_OR_OTHER|||||||0.219|||||||ANCOVA|P-value was calculated from ANCOVA, with centre, surgery type and treatment included as covariates in the analysis.||At Hour 24||||0.219
71021739|NCT00766506|141551173|SUPERIORITY_OR_OTHER|||||||0.299|||||||ANCOVA|P-value was calculated from ANCOVA, with centre, surgery type and treatment included as covariates in the analysis.||At Hour 48||||0.299
71021740|NCT00766506|141551173|SUPERIORITY_OR_OTHER|||||||0.136|||||||ANCOVA|P-value was calculated from ANCOVA, with centre, surgery type and treatment included as covariates in the analysis.||At study discontinuation or withdrawal||||0.136
71021741|NCT00766506|141551174|SUPERIORITY_OR_OTHER||Least square mean difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.74|-0.3|||ANCOVA|P-value was calculated from ANCOVA, with centre, surgery type and treatment included as covariates in the analysis.|Least square mean difference = Least square mean value for Fentanyl IONSYS group minus Least square mean value for Morphine IV PCA group|||-0.30|-0.74|<0.001
71021742|NCT00766506|141551175|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.131|TWO_SIDED|95.0|0.84|3.92|||Mantel Haenszel|P-value was calculated from a Mantel-Haenszel Chi-Squared test.||||3.92|0.84|0.131
71021743|NCT00766506|141551176|SUPERIORITY_OR_OTHER|||||||0.342|||||||Log Rank|P-value was calculated from a log-rank test stratified for surgery type.||||||0.342
71021744|NCT00766506|141551177|SUPERIORITY_OR_OTHER|||||||0.836|||||||Log Rank|P-value was calculated from a log-rank test stratified for surgery type.||||||0.836
71021745|NCT00766506|141551178|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0||||0.029|TWO_SIDED|95.0|1.04|24.03|||Chi-squared|||||24.03|1.04|0.029
71021746|NCT00766506|141551180|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.23|TWO_SIDED|95.0|0.74|3.53|||Chi-squared|||Paracetamol: P-value was calculated using Chi-squared test.||3.53|0.74|0.230
71021747|NCT00766506|141551180|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72||||0.163|TWO_SIDED|95.0|0.8|3.7|||Chi-squared|||NSAID's: P-value was calculated using Chi-squared test.||3.70|0.80|0.163
71021748|NCT02496221|141551182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0021||||0.1229|TWO_SIDED|95.0|-20.5781|2.5739|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect||||2.5739|-20.5781|0.1229
71021749|NCT02496221|141551183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-545.9585||||0.1291|TWO_SIDED|95.0|-1260.0|168.0858|||Mixed Models Analysis|||||168.0858|-1260.00|0.1291
71021750|NCT02496221|141551185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2992||||0.0317|TWO_SIDED|95.0|-31.0762|-1.5223|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect||||-1.5223|-31.0762|0.0317
71021751|NCT02496221|141551186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|252.6099||||0.0291|TWO_SIDED|95.0|29.5081|475.7117|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect||||475.7117|29.5081|0.0291
71021752|NCT02496221|141551187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3748||||0.7961|TWO_SIDED|95.0|-3.4109|2.6614|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect||||2.6614|-3.4109|0.7961
71021753|NCT02496221|141551189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001526||||0.9424|TWO_SIDED|95.0|-0.045665|0.048717|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect||||0.048717|-0.045665|0.9424
71021754|NCT02496221|141551190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01456||||0.0733|TWO_SIDED|95.0|-0.030666|0.001554|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect||||0.001554|-0.030666|0.0733
71021755|NCT01893983|141551201|EQUIVALENCE|Compare whether 2 groups had any difference in risk/hazard of mental health engagement at any time during follow-up.|Cox Proportional Hazard|1.13||||0.66|TWO_SIDED|95.0|0.81|1.58||P value 0.05 is the threshold for statistical significance|Regression, Cox|Adjusted for site, mental health treatment history and mental health symptom severity at baseline, baseline amphetamine and opioid scores.|The referral alone arm is the reference group (denominator), and the motivational coaching arm is the numerator.|Compare 2 groups in regard to time to first mental health treatment using Cox proportional hazards regression.||1.58|0.81|0.660
71054611|NCT02792699|141613103|OTHER||LS Mean Difference|-2.06|||||TWO_SIDED|90.0|-8.052|3.933||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 12, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||3.933|-8.052|
71054612|NCT02792699|141613103|OTHER||LS Mean Difference|-1.32|||||TWO_SIDED|90.0|-7.62|4.979||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||4.979|-7.620|
70941645|NCT04748445|141383934|OTHER||Slope|0.04771|STANDARD_ERROR_OF_MEAN|3.351||0.157|TWO_SIDED|90.0|-0.007823|0.1032|||Mixed Models Analysis|||EE\_SNR (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1032|-0.007823|0.1570
71021756|NCT01120600|141551205|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|5.59|||<|0.001|TWO_SIDED|95.0|4.48|6.7|||cLDA|||A constrained full likelihood longitudinal data analysis (cLDA) method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||6.7|4.48|< 0.001
71021757|NCT01120600|141551206|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.02|||<|0.001|TWO_SIDED|95.0|1.27|2.77|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||2.77|1.27|< 0.001
71021758|NCT01120600|141551207|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.69|||=|0.008|TWO_SIDED|95.0|0.45|2.93|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||2.93|0.45|= 0.008
71021759|NCT01120600|141551208|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.12|||<|0.001|TWO_SIDED|95.0|0.93|3.3|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||3.3|0.93|< 0.001
71021760|NCT01120600|141551209|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-76.58|||<|0.001|TWO_SIDED|95.0|-92.56|-60.61|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||-60.61|-92.56|< 0.001
71054613|NCT02792699|141613103|OTHER||LS Mean Difference|0.73|||||TWO_SIDED|90.0|-5.691|7.15||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 24, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||7.150|-5.691|
71054614|NCT02792699|141613103|OTHER||LS Mean Difference|-2.207|||||TWO_SIDED|90.0|-8.562|1.417||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||1.417|-8.562|
71054615|NCT02792699|141613103|OTHER||LS Mean Difference|-0.036|||||TWO_SIDED|90.0|-6.497|6.424||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 40, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||6.424|-6.497|
71054616|NCT02792699|141613103|OTHER||LS Mean Difference|-6.629|||||TWO_SIDED|90.0|-13.455|0.197||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.197|-13.455|
70851366|NCT00669409|141190548|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-27.5|STANDARD_ERROR_OF_MEAN|10.3|||TWO_SIDED|95.0|-47.8|-7.1||||||Change at Week 4, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-7.1|-47.8|
71054617|NCT02792699|141613103|OTHER||LS Mean Difference|-3.096|||||TWO_SIDED|90.0|-9.883|3.691||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 48, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||3.691|-9.883|
71054618|NCT02792699|141613104|OTHER||Risk Difference (RD)|-0.0245|||||TWO_SIDED|90.0|-0.1083|0.0593|||||Based on a generalized linear model adjusted for geographic region, seropositivity and prior biologic use as covariates in the model.|||0.0593|-0.1083|
71054619|NCT02792699|141613104|OTHER||Risk Difference (RD)|0.0187|||||TWO_SIDED|90.0|-0.061|0.0984|||||Based on a generalized linear model adjusted for geographic region, seropositivity and prior biologic use as covariates in the model.|||0.0984|-0.0610|
71054620|NCT00875797|141613125|NON_INFERIORITY_OR_EQUIVALENCE|t-test||||||0.05|TWO_SIDED|95.0||||p\<0.05|t-test, 2 sided|||||||0.05
70851367|NCT00669409|141190548|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-25.5|7.4||||||Change at Week 4, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.4|-25.5|
71054621|NCT00875797|141613126|NON_INFERIORITY_OR_EQUIVALENCE|χ2 test|percentage of infection|20.0|STANDARD_DEVIATION|10.0||0.05|TWO_SIDED|95.0||||p\<0.05|Chi-squared|2 degrees of freedom||||||0.05
71054622|NCT00875797|141613127|SUPERIORITY_OR_OTHER||percentage of survivers|80.0|||<|0.05||95.0||||p\<0.05|Chi-squared, Corrected|2-degrees of freedom||Chi-square||||<0.05
71054623|NCT04558918|141613129|SUPERIORITY||Odds Ratio (OR)|338.25|||<|0.0001|TWO_SIDED|95.0|25.07|4564.14||two sided unadjusted p-value|Regression, Logistic|Logistic regression model using Firth||||4564.14|25.07|<0.0001
71054624|NCT04558918|141613129|SUPERIORITY||Difference in marginal proportion|80.2|||||TWO_SIDED|95.0|71.2|87.6||||||||87.6|71.2|
71054625|NCT04558918|141613130|SUPERIORITY||Odds Ratio (OR)|495.74|||<|0.0001|TWO_SIDED|95.0|24.41|10066.53||two sided unadjusted p-value|Regression, Logistic|Logistic regression model using Firth||||10066.53|24.41|<0.0001
71054626|NCT04558918|141613130|SUPERIORITY||Diff. in marginal proportion|67.0|||||TWO_SIDED|95.0|56.4|76.9||||||||76.9|56.4|
71054627|NCT04558918|141613133|OTHER||Adjusted mean difference|-0.01|||||TWO_SIDED|95.0|-0.53|0.51||||||||0.51|-0.53|
71054628|NCT04558918|141613134|OTHER||Adjusted mean difference|-1.17|||||TWO_SIDED|95.0|-4.01|1.68||||||||1.68|-4.01|
71054629|NCT04558918|141613135|SUPERIORITY||Odds Ratio (OR)|108.41|||<|0.0001|TWO_SIDED|95.0|17.25|681.24||two sided unadjusted p-value|Conditional logistic regression|||||681.24|17.25|<0.0001
71054630|NCT04558918|141613135|SUPERIORITY||Diff. in marginal proportion|68.9|||||TWO_SIDED|95.0|51.4|83.9||||||logistic regression model||83.9|51.4|
71054631|NCT04558918|141613136|SUPERIORITY||Adjusted mean diff.|3.66|||<|0.0001|TWO_SIDED|95.0|3.2|4.12||two sided unadjusted p-value|Mixed Model of Repeated Measures (MMRM)|||||4.12|3.20|<0.0001
71054632|NCT04558918|141613137|SUPERIORITY||Mean Difference (Net)|8.29|||<|0.0001|TWO_SIDED|95.0|5.28|11.29||two sided unadjusted p-value|Mixed Model of Repeated Measures (MMRM)|||||11.29|5.28|<0.0001
71054633|NCT04558918|141613138|SUPERIORITY||Mean Difference (Net)|-116.15|||<|0.0001|TWO_SIDED|95.0|-132.04|-100.26||two sided unadjusted p-value|Mixed Model of Repeated Measures (MMRM)|||||-100.26|-132.04|<0.0001
71054634|NCT04558918|141613139|SUPERIORITY||Geometric mean ratio|0.99||||0.8361|TWO_SIDED|95.0|0.89|1.1||two sided unadjusted p-value|Mixed Model of Repeated Measures (MMRM)|||||1.10|0.89|0.8361
71054635|NCT04558918|141613140|SUPERIORITY||Rate ratio|0.1||||0.01183|TWO_SIDED|95.0|0.02|0.61||two sided unadjusted p-value|Negative binomial model|||||0.61|0.02|0.01183
71054636|NCT04558918|141613140|SUPERIORITY||Rate difference|-0.6|||||TWO_SIDED|95.0|-1.24|0.04||||||||0.04|-1.24|
71054637|NCT04558918|141613141|SUPERIORITY||rate difference|0.03||||0.31731|TWO_SIDED|95.0|-0.03|0.1||two sided unadjusted p-value|Poisson model|||||0.10|-0.03|0.31731
71054638|NCT04558918|141613142|OTHER||Adjusted mean difference|1.69|||||TWO_SIDED|95.0|-16.86|20.23||||||||20.23|-16.86|
71054639|NCT04558918|141613143|OTHER||Geometric mean ratio|1.12|||||TWO_SIDED|95.0|0.97|1.3||||||||1.30|0.97|
71054640|NCT01338870|141613146|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.145||0.7606|TWO_SIDED|80.0|-0.08|0.29|||Mixed Models Analysis|||Treatment difference and 80% confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||0.29|-0.08|0.7606
70932903|NCT06140290|141365880|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|91.8|||||TWO_SIDED|90.0|77.76|108.38|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA (Analysis of variance) model with treatment as a fixed effect.||108.38|77.76|
71021761|NCT01120600|141551210|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-68.08|||<|0.001|TWO_SIDED|95.0|-78.1|-58.06|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||-58.06|-78.1|< 0.001
71021762|NCT01120600|141551211|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-7.94|||=|0.019|TWO_SIDED|95.0|-14.58|-1.31|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||-1.31|-14.58|= 0.019
71021763|NCT01120600|141551212|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-16.0|||=|0.001|TWO_SIDED|95.0|-25.74|-6.27|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||-6.27|-25.74|= 0.001
71021764|NCT03877237|141551229|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|4.23||||0.02164|TWO_SIDED|95.0|0.96|8.22||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate.|Rank ANCOVA|Model includes baseline rank of outcome variable as a covariate, treatment group as a factor, and is stratified by T2DM status at randomization.||"For the primary efficacy endpoint KCCQ-TSS, the following hypothesis was tested using the significance level 0.04990~* H0: m(r(A)) = m(r(C)) versus~* H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in the primary efficacy endpoint, KCCQ-TSS, from baseline to week 16, among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively."||8.22|0.96|0.02164
71021765|NCT03877237|141551230|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|4.17||||0.05842|TWO_SIDED|95.0|0.03|8.33||KCCQ-PLS was tested at the alpha level of 0.04990 because KCCQ-TSS had a statistically significant p-value, in accordance with the pre-specified testing strategy.|Rank ANCOVA|Model includes baseline rank of outcome variable as a covariate, treatment group as a factor, and is stratified by T2DM status at randomization.||"For the primary efficacy endpoint KCCQ-PLS, the following hypothesis was tested at significant level of 0.04990~* H0: m(r(A)) = m(r(C)) versus~* H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in the primary efficacy endpoint, KCCQ-PLS, from baseline to week 16, among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively."||8.33|0.03|0.05842
71054641|NCT01338870|141613146|SUPERIORITY_OR_OTHER||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.142||0.0266|TWO_SIDED|80.0|-0.46|-0.09|||Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.09|-0.46|0.0266
71054642|NCT01338870|141613146|SUPERIORITY_OR_OTHER||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.141||0.044|TWO_SIDED|80.0|-0.42|-0.06|||Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.06|-0.42|0.0440
71054643|NCT01338870|141613146|SUPERIORITY_OR_OTHER||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.137||0.0001|TWO_SIDED|80.0|-0.71|-0.36|||Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.36|-0.71|0.0001
71054644|NCT01338870|141613146|SUPERIORITY_OR_OTHER||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.139||0.0013|TWO_SIDED|80.0|-0.6|-0.25|||Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.25|-0.60|0.0013
71054645|NCT01338870|141613147|SUPERIORITY_OR_OTHER||LS mean difference|-5.21|STANDARD_ERROR_OF_MEAN|5.7||0.3611|TWO_SIDED|95.0|-16.4|5.98|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||5.98|-16.40|0.3611
71054646|NCT01338870|141613147|SUPERIORITY_OR_OTHER||LS mean difference|-9.45|STANDARD_ERROR_OF_MEAN|5.686||0.0969|TWO_SIDED|95.0|-20.61|1.71|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.71|-20.61|0.0969
71054647|NCT01338870|141613147|SUPERIORITY_OR_OTHER||LS mean difference|-8.1|STANDARD_ERROR_OF_MEAN|5.71||0.1566|TWO_SIDED|95.0|-19.3|3.11|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||3.11|-19.30|0.1566
71106700|NCT00427193|141720070|OTHER||difference in mean change|0.02|STANDARD_DEVIATION|0.02||0.7|TWO_SIDED|95.0|-0.019|0.059||Type I error was controlled using a hierarchical gatekeeping strategy.|Mixed Models Analysis|||All analysis under intention-to-treat. All observations were included The primary analytic was a repeated measures analysis. The dependent variable was the change from baseline 12 \& 14mos., with treatment, time, and the treatment × time interaction as independent variables. Site, sex, BMI stratum, and the baseline value of the outcome were included as covariates. The predicted mean changes ± standard errors are the adjusted values from the contrasts of the multiple timepoints.||0.059|-0.019|0.70
70932904|NCT06140290|141365880|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment G) without practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|102.71|||||TWO_SIDED|90.0|86.33|122.19|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||122.19|86.33|
70932905|NCT06140290|141365881|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|86.34|||||TWO_SIDED|90.0|69.42|107.37|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||107.37|69.42|
70941646|NCT04748445|141383934|OTHER||Slope|0.0008053|STANDARD_ERROR_OF_MEAN|9.807||0.4131|TWO_SIDED|90.0|-0.0008199|0.002431|||Mixed Models Analysis|||EE\_Shimmer Local dB (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.002431|-0.0008199|0.4131
71054648|NCT01338870|141613147|SUPERIORITY_OR_OTHER||LS mean difference|-15.92|STANDARD_ERROR_OF_MEAN|5.678||0.0052|TWO_SIDED|95.0|-27.06|-4.77|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-4.77|-27.06|0.0052
71054649|NCT01338870|141613147|SUPERIORITY_OR_OTHER||LS mean difference|-21.09|STANDARD_ERROR_OF_MEAN|5.712||0.0002|TWO_SIDED|95.0|-32.3|-9.88|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-9.88|-32.30|0.0002
71054650|NCT01338870|141613147|SUPERIORITY_OR_OTHER||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|5.852||0.9893|TWO_SIDED|95.0|-11.41|11.56|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||11.56|-11.41|0.9893
71054651|NCT01338870|141613147|SUPERIORITY_OR_OTHER||LS mean difference|-4.14|STANDARD_ERROR_OF_MEAN|5.814||0.4767|TWO_SIDED|95.0|-15.55|7.27|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||7.27|-15.55|0.4767
71054652|NCT01338870|141613147|SUPERIORITY_OR_OTHER||LS mean difference|-2.87|STANDARD_ERROR_OF_MEAN|5.816||0.6222|TWO_SIDED|95.0|-14.28|8.55|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||8.55|-14.28|0.6222
71054653|NCT01338870|141613147|SUPERIORITY_OR_OTHER||LS mean difference|-13.88|STANDARD_ERROR_OF_MEAN|5.744||0.0159|TWO_SIDED|95.0|-25.16|-2.61|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-2.61|-25.16|0.0159
71054654|NCT01338870|141613147|SUPERIORITY_OR_OTHER||LS mean difference|-18.69|STANDARD_ERROR_OF_MEAN|5.735||0.0012|TWO_SIDED|95.0|-29.95|-7.44|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-7.44|-29.95|0.0012
71054655|NCT01338870|141613147|SUPERIORITY_OR_OTHER||LS mean difference|3.86|STANDARD_ERROR_OF_MEAN|5.895||0.5125|TWO_SIDED|95.0|-7.71|15.43|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||15.43|-7.71|0.5125
71054656|NCT01338870|141613147|SUPERIORITY_OR_OTHER||LS mean difference|-8.47|STANDARD_ERROR_OF_MEAN|5.815||0.1455|TWO_SIDED|95.0|-19.89|2.94|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.94|-19.89|0.1455
71054657|NCT01338870|141613147|SUPERIORITY_OR_OTHER||LS mean difference|0.94|STANDARD_ERROR_OF_MEAN|5.794||0.8712|TWO_SIDED|95.0|-10.43|12.31|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||12.31|-10.43|0.8712
71054658|NCT01338870|141613147|SUPERIORITY_OR_OTHER||LS mean difference|-19.57|STANDARD_ERROR_OF_MEAN|5.707||0.0006|TWO_SIDED|95.0|-30.77|-8.36|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-8.36|-30.77|0.0006
71054659|NCT01338870|141613147|SUPERIORITY_OR_OTHER||LS mean difference|-19.08|STANDARD_ERROR_OF_MEAN|5.696||0.0008|TWO_SIDED|95.0|-30.26|-7.9|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-7.90|-30.26|0.0008
71054660|NCT01338870|141613147|SUPERIORITY_OR_OTHER||LS mean difference|6.99|STANDARD_ERROR_OF_MEAN|6.055||0.2488|TWO_SIDED|95.0|-4.9|18.87|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||18.87|-4.90|0.2488
71106701|NCT00427193|141720071|OTHER||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.02||0.84|TWO_SIDED|95.0|-0.0092|0.069|||Mixed Models Analysis|||||0.069|-0.0092|0.84
71106702|NCT00427193|141720072|OTHER||Mean Difference (Net)|-82.0|STANDARD_ERROR_OF_MEAN|11.12|<|0.001|TWO_SIDED|95.0|-103.8|-60.2|||Mixed Models Analysis|||||-60.2|-103.8|<0.001
71021766|NCT03877237|141551231|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|3.2||||0.68626|TWO_SIDED|95.0|-6.5|13.0||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate.|Rank ANCOVA|Model includes baseline rank of outcome variable as a covariate, treatment group as a factor, and is stratified by T2DM status at randomization.||"For the primary efficacy endpoint 6MWD, the following hypothesis was tested using the significance level 0.00010:~H0: m(r(A)) = m(r(C)) versus H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in the primary efficacy endpoint, 6MWD, from baseline to week 16, among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively."||13.0|-6.5|0.68626
71021767|NCT03877237|141551232|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|-0.16||||0.19748|TWO_SIDED|95.0|-0.55|0.22||Total time spent in LVPA was not tested for statistical significance and the p-value is considered nominal because the test for 6MWD was not statistically significant.|Rank ANCOVA|Model includes baseline rank of outcome variable as a covariate, treatment group as a factor, and is stratified by T2DM status at randomization.||"For the secondary efficacy endpoint, total time spent in LVPA, the testing hypothesis is~* H0: m(r(A)) = m(r(C)) versus~* H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in secondary efficacy endpoint, total time spent in LVPA, from baseline to End of study among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively."||0.22|-0.55|0.19748
71021768|NCT00382291|141551244|SUPERIORITY_OR_OTHER|||||||0.2106||95.0|||||Kruskal-Wallis|||Data were analyzed using two-sided Kruskal-Wallis test with level of significance = .05. Null hypothesis was that there were no group differences. The maximum CGI-SA obtained over course of study was the outcome measure.||||.2106
71021769|NCT00382291|141551245|SUPERIORITY_OR_OTHER|||||||0.8831|TWO_SIDED|95.0|||||ANCOVA|||Data were analyzed using ANCOVA modeling with two-sided testing and level of significance = .05. The dependent variable was last measured CY-BOCS score, the independent variable was randomized group assignment and the covariate was the CY-BOCS score at baseline. The null hypothesis was that there were no group differences.||||.8831
71021770|NCT00265083|141551253|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The positive test is defined if the comparison between combined golimumab and placebo is significant (p-value \<0.05), and at least one of the pair-wise comparisons is also significant (p-value \<0.05).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (\<=1.5mg/dL, \>1.5mg/dL)||Null hypothesis: No difference in ASAS 20 response comparing Groups I vs II and Groups I vs III. The sample size of 75 patients (pts) in placebo and 135 pts per active group will provide \>=99% power to detect a difference in ASAS 20 response between treatment groups at alpha=0.05, assuming 50% of pts with screening CRP\<1.5mg/dL, and the difference in ASAS 20 response of 10-27.5% in pts with screening CRP\<1.5mg/dL and 32.5-45% in pts with screening CRP\>=1.5mg/dL, between Groups I vs II or III.||||<0.001
71021771|NCT00265083|141551253|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (\<=1.5mg/dL, \>1.5mg/dL)||||||<0.001
71021772|NCT00265083|141551253|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (\<=1.5mg/dL, \>1.5mg/dL)||||||<0.001
71021773|NCT00265083|141551254|SUPERIORITY_OR_OTHER||||||<|0.001||||||The positive test is defined if the comparison between combined golimumab and placebo is significant (p-value \<0.05), and at least one of the pair-wise comparisons is also significant (p-value \<0.05).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (\<=1.5mg/dL, \>1.5mg/dL)||Null hypothesis: No difference in ASAS 20 response comparing Groups I vs. II and Groups I vs. III.||||<0.001
71021774|NCT00265083|141551254|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (\<=1.5mg/dL, \>1.5mg/dL)||Null hypothesis: no difference in ASAS 20 response between Group II and Group I.||||<0.001
71021775|NCT00265083|141551254|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (\<=1.5mg/dL, \>1.5mg/dL)||Null hypothesis: no difference in ASAS 20 response between Group III and Group I.||||<0.001
71106703|NCT00427193|141720073|OTHER||Mean Difference (Final Values)|-64.0|STANDARD_DEVIATION|13.5|<|0.0001|TWO_SIDED|95.0|-90.5|-37.5|||Mixed Models Analysis|||||-37.5|-90.5|<0.0001
71021776|NCT00265083|141551255|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The positive test is defined if the comparison between combined golimumab and placebo is significant (p-value \<0.05), and at least one of the pair-wise comparisons is also significant (p-value \<0.05).|ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: No difference in change from baseline in BASFI comparing Groups I vs. II and Groups I vs. III.||||<0.001
71021777|NCT00265083|141551255|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: no difference in BASFI between Group II and Group I.||||<0.001
71054661|NCT01338870|141613147|SUPERIORITY_OR_OTHER||LS mean difference|-7.56|STANDARD_ERROR_OF_MEAN|6.004||0.2084|TWO_SIDED|95.0|-19.34|4.23|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||4.23|-19.34|0.2084
71106704|NCT00427193|141720074|OTHER||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.1||0.82|TWO_SIDED|95.0|-0.16|0.23|||Mixed Models Analysis|||||0.23|-0.16|0.82
71054662|NCT01338870|141613147|SUPERIORITY_OR_OTHER||LS mean difference|0.71|STANDARD_ERROR_OF_MEAN|5.971||0.9053|TWO_SIDED|95.0|-11.01|12.43|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||12.43|-11.01|0.9053
71054663|NCT01338870|141613147|SUPERIORITY_OR_OTHER||LS mean difference|-15.3|STANDARD_ERROR_OF_MEAN|5.853||0.0091|TWO_SIDED|95.0|-26.79|-3.81|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-3.81|-26.79|0.0091
71054664|NCT01338870|141613147|SUPERIORITY_OR_OTHER||LS mean difference|-18.62|STANDARD_ERROR_OF_MEAN|5.875||0.0016|TWO_SIDED|95.0|-30.15|-7.09|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-7.09|-30.15|0.0016
71054665|NCT01338870|141613147|SUPERIORITY_OR_OTHER||LS mean difference|6.5|STANDARD_ERROR_OF_MEAN|6.217||0.2963|TWO_SIDED|95.0|-5.71|18.7|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||18.70|-5.71|0.2963
71054666|NCT01338870|141613147|SUPERIORITY_OR_OTHER||LS mean difference|-9.71|STANDARD_ERROR_OF_MEAN|6.17||0.1159|TWO_SIDED|95.0|-21.82|2.4|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.40|-21.82|0.1159
71054667|NCT01338870|141613147|SUPERIORITY_OR_OTHER||LS mean difference|4.7|STANDARD_ERROR_OF_MEAN|6.103||0.4413|TWO_SIDED|95.0|-7.28|16.68|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||16.68|-7.28|0.4413
71054668|NCT01338870|141613147|SUPERIORITY_OR_OTHER||LS mean difference|-15.3|STANDARD_ERROR_OF_MEAN|5.918||0.0099|TWO_SIDED|95.0|-26.91|-3.68|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-3.68|-26.91|0.0099
71054669|NCT01338870|141613147|SUPERIORITY_OR_OTHER||LS mean difference|-14.95|STANDARD_ERROR_OF_MEAN|5.981||0.0126|TWO_SIDED|95.0|-26.69|-3.21|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-3.21|-26.69|0.0126
71054670|NCT01338870|141613148|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.058||0.1797|TWO_SIDED|80.0|-0.13|0.02|||Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||0.02|-0.13|0.1797
71054671|NCT01338870|141613148|SUPERIORITY_OR_OTHER||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.058||0.0234|TWO_SIDED|95.0|-0.19|-0.04|||Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.04|-0.19|0.0234
71054672|NCT01338870|141613148|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.058||0.04|TWO_SIDED|80.0|-0.18|-0.03|||Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.03|-0.18|0.0400
71021778|NCT00265083|141551255|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: no difference in BASFI between Group III and Group I.||||<0.001
71021779|NCT00265083|141551256|SUPERIORITY_OR_OTHER|||||||0.288||95.0||||The positive test is defined if the comparison between combined golimumab and placebo is significant at the 0.05, and at least one of the pair-wise comparisons is also significant at the 0.05.|ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: No difference in change from baseline in BASMI comparing Groups I vs. II and Groups I vs. III.||||0.288
71021780|NCT00265083|141551256|SUPERIORITY_OR_OTHER|||||||0.444||95.0|||||ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: no difference in BASMI between Group II and Group I.||||0.444
71021781|NCT00265083|141551256|SUPERIORITY_OR_OTHER|||||||0.247||95.0|||||ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: no difference in BASMI between Group III and Group I.||||0.247
71021782|NCT01314703|141551297|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.85|STANDARD_ERROR_OF_MEAN|0.089|||TWO_SIDED|95.0|2.66|3.02|||ANOVA||ChloraPrep 10 minute abdomen|Hypothesis: ChloraPrep will exceed 3 log 10 reduction for the groin at 10 minutes and 2 log 10 reduction for the abdomen at 10 minutes. The 70% Isopropyl Alcohol was used as a positive control. All calculations were performed after taking the base-10 logarithm of the original values. The model was a mixed model Analysis of Variance (ANOVA).||3.02|2.66|
71021783|NCT01314703|141551297|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.038|STANDARD_ERROR_OF_MEAN|0.149|||TWO_SIDED|95.0|3.74|4.33|||ANOVA||ChloraPrep 10 minute groin|Hypothesis: ChloraPrep will exceed 3 log 10 reduction for the groin at 10 minutes and 2 log 10 reduction for the abdomen at 10 minutes. The 70% Isopropyl Alcohol was used as a positive control. All calculations were performed after taking the base-10 logarithm of the original values. The model was a mixed model Analysis of Variance (ANOVA).||4.33|3.74|
71054673|NCT01338870|141613148|SUPERIORITY_OR_OTHER||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.057||0.1568|TWO_SIDED|80.0|-0.13|0.02|||Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||0.02|-0.13|0.1568
71054674|NCT01338870|141613148|SUPERIORITY_OR_OTHER||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.058||0.001|TWO_SIDED|80.0|-0.25|-0.11|||Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.11|-0.25|0.0010
71054675|NCT01338870|141613148|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.0695|TWO_SIDED|80.0|-0.19|-0.01|||Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.01|-0.19|0.0695
70851368|NCT00669409|141190548|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.7|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-36.1|-3.2||||||Change at Week 4, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.2|-36.1|
71021784|NCT01314703|141551297|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.53|STANDARD_ERROR_OF_MEAN|0.089|||TWO_SIDED|95.0|2.36|2.7|||ANOVA||70%Isopropyl Alcohol 10 minute abdomen|Hypothesis: ChloraPrep will exceed 3 log 10 reduction for the groin at 10 minutes and 2 log 10 reduction for the abdomen at 10 minutes. The 70% Isopropyl Alcohol was used as a positive control. All calculations were performed after taking the base-10 logarithm of the original values. The model was a mixed model Analysis of Variance (ANOVA).||2.70|2.36|
71021785|NCT01314703|141551297|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.53|STANDARD_ERROR_OF_MEAN|0.149|||TWO_SIDED|95.0|3.24|3.82|||ANOVA||70% Isopropyl Alcohol 10 minute groin|Hypothesis: ChloraPrep will exceed 3 log 10 reduction for the groin at 10 minutes and 2 log 10 reduction for the abdomen at 10 minutes. The 70% Isopropyl Alcohol was used as a positive control. All calculations were performed after taking the base-10 logarithm of the original values. The model was a mixed model Analysis of Variance (ANOVA).||3.82|3.24|
71021786|NCT02499354|141551327|SUPERIORITY|||||||0.2742|||||||t-test, 1 sided|||||||0.2742
71021787|NCT02499354|141551328|SUPERIORITY|||||||0.55|||||||Chi-squared|||||||0.55
71021788|NCT00919802|141551381|OTHER|||||||0.688|||||||t-test, 2 sided|||Global Response Assessment (GRA) scores were obtained 6 and 24 hours post oxytocin or saline administration.||||0.688
71021789|NCT00919802|141551382|OTHER|paired t-test comparison of change in VAR from baseline 6 hours after drug; a change in VAR score was calculated for each subject for each arm and compared using a paired t-test||||||0.7252|||||||t-test, 2 sided|||||||0.7252
71054676|NCT01338870|141613148|SUPERIORITY_OR_OTHER||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.069||0.0636|TWO_SIDED|80.0|-0.2|-0.02|||Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.02|-0.20|0.0636
71054677|NCT01338870|141613148|SUPERIORITY_OR_OTHER||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.069||0.0512|TWO_SIDED|80.0|-0.2|-0.02|||Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.02|-0.20|0.0512
71054678|NCT01338870|141613148|SUPERIORITY_OR_OTHER||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.068||0.0051|TWO_SIDED|80.0|-0.26|-0.09|||Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.09|-0.26|0.0051
71054679|NCT01338870|141613148|SUPERIORITY_OR_OTHER||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.069||0.0009|TWO_SIDED|80.0|-0.3|-0.13|||Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.13|-0.30|0.0009
71054680|NCT01338870|141613148|SUPERIORITY_OR_OTHER||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.094||0.2392|TWO_SIDED|80.0|-0.19|0.05|||Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||0.05|-0.19|0.2392
71054681|NCT01338870|141613148|SUPERIORITY_OR_OTHER||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.091||0.0308|TWO_SIDED|80.0|-0.29|-0.05|||Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.05|-0.29|0.0308
71054682|NCT01338870|141613148|SUPERIORITY_OR_OTHER||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.091||0.0019|TWO_SIDED|80.0|-0.38|-0.15|||Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.15|-0.38|0.0019
70941647|NCT04748445|141383934|OTHER||Slope|-0.03945|STANDARD_ERROR_OF_MEAN|1.892||0.0391|TWO_SIDED|90.0|-0.0708|-0.008096|||Mixed Models Analysis|||EE\_Spectral Flatness (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.008096|-0.07080|0.0391
71054683|NCT01338870|141613148|SUPERIORITY_OR_OTHER||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.089||0.0034|TWO_SIDED|80.0|-0.36|-0.13|||Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.13|-0.36|0.0034
71054684|NCT01338870|141613148|SUPERIORITY_OR_OTHER||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.09||0.0002|TWO_SIDED|80.0|-0.44|-0.21|||Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.21|-0.44|0.0002
71054685|NCT01338870|141613148|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.126||0.7854|TWO_SIDED|80.0|-0.06|0.26|||Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||0.26|-0.06|0.7854
71054686|NCT01338870|141613148|SUPERIORITY_OR_OTHER||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.123||0.0778|TWO_SIDED|80.0|-0.33|-0.02|||Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.02|-0.33|0.0778
71054687|NCT01338870|141613148|SUPERIORITY_OR_OTHER||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.122||0.0065|TWO_SIDED|80.0|-0.46|-0.15|||Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.15|-0.46|0.0065
71054688|NCT01338870|141613148|SUPERIORITY_OR_OTHER||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.119||0.0011|TWO_SIDED|80.0|-0.52|-0.21|||Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.21|-0.52|0.0011
71054689|NCT01338870|141613148|SUPERIORITY_OR_OTHER||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.121||0.0013|TWO_SIDED|80.0|-0.52|-0.21|||Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.21|-0.52|0.0013
71054690|NCT01338870|141613150|SUPERIORITY_OR_OTHER||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.272||0.5636|TWO_SIDED|95.0|-0.69|0.38|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.38|-0.69|0.5636
71054691|NCT01338870|141613150|SUPERIORITY_OR_OTHER||LS mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.271||0.4889|TWO_SIDED|95.0|-0.35|0.72|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.72|-0.35|0.4889
71021790|NCT01455545|141551392|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.999||||0.967|TWO_SIDED|95.0|0.962|1.037|||Regression, Logistic|||Ho = no differences in ASK-20 results between both groups H1= there are differences between both groups. Comparison of two means. Unilateral test. (1-alpha)=95%. Statistic power: 90%. Precision: 10. S square: 256. Sample size: 44. Sample size adjusted to losses: 46 patients.||1.037|0.962|0.967
71021791|NCT01455545|141551393|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.001||||0.861|TWO_SIDED|95.0|0.985|1.018|||Regression, Logistic|||||1.018|0.985|0.861
71021792|NCT01455545|141551394|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.625||||0.252|TWO_SIDED|95.0|0.706|3.739|||Chi-squared|||Ho = no differences in gender results between both groups H1= there are differences between both groups. Cross tab Chi square||3.739|0.706|0.252
71021793|NCT01455545|141551395|SUPERIORITY_OR_OTHER|||||||0.217||95.0|||||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Chi - square||||0.217
71021794|NCT01455545|141551396|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.643|TWO_SIDED|95.0|0.376|1.829|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi square||1.829|0.376|0.643
71021795|NCT01455545|141551397|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.556||||0.155|TWO_SIDED|95.0|0.247|1.253|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi squared test.||1.253|0.247|0.155
71021796|NCT01455545|141551398|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.19||||0.107|TWO_SIDED|95.0|0.02|1.763|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi squared test.||1.763|0.020|0.107
71021797|NCT01455545|141551399|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.849||||0.196|TWO_SIDED|95.0|1.541|2.219|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi squared test.||2.219|1.541|0.196
71021798|NCT01455545|141551400|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.135||||0.15|TWO_SIDED|95.0|0.618|15.91|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi squared test.||15.91|0.618|0.150
71054692|NCT01338870|141613150|SUPERIORITY_OR_OTHER||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.272||0.5849|TWO_SIDED|95.0|-0.68|0.39|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.39|-0.68|0.5849
71021799|NCT01455545|141551401|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.096||||0.822|TWO_SIDED|95.0|0.492|2.441|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Comparison of two proportions. Unilateral test. (1-alpha)=95%. Proportion: 90%. Precision: 10%. Sample size: 35. Sample size adjusted to losses: 41 patients.||2.441|0.492|0.822
71021800|NCT01455545|141551402|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
71021801|NCT01455545|141551402|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.038||||0.005|TWO_SIDED|95.0|1.012|1.065|||Regression, Logistic|||||1.065|1.012|0.005
71054693|NCT01338870|141613150|SUPERIORITY_OR_OTHER||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.268||0.5104|TWO_SIDED|95.0|-0.7|0.35|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.35|-0.70|0.5104
71054694|NCT01338870|141613150|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.269||0.264|TWO_SIDED|95.0|-0.83|0.23|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.23|-0.83|0.2640
70851369|NCT00669409|141190548|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.4|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-22.1|11.3||||||Change at Week 4, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.3|-22.1|
70851370|NCT00669409|141190548|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.7|STANDARD_ERROR_OF_MEAN|8.22|||TWO_SIDED|95.0|-30.9|1.6||||||Change at Week 4, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.6|-30.9|
71021802|NCT01455545|141551403|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.35||||0.013|TWO_SIDED|95.0|0.153|0.799|||Regression, Logistic|||Ho = no differences between both groups H1= there are differences between both groups.||0.799|0.153|0.013
71021803|NCT00106028|141551404|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.438||||0.0625|TWO_SIDED|95.0|-0.235|9.111|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||9.111|-0.235|0.0625
71054695|NCT01338870|141613150|SUPERIORITY_OR_OTHER||LS mean difference|-0.71|STANDARD_ERROR_OF_MEAN|0.357||0.0464|TWO_SIDED|95.0|-1.42|-0.01|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.01|-1.42|0.0464
71054696|NCT01338870|141613150|SUPERIORITY_OR_OTHER||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.353||0.7107|TWO_SIDED|95.0|-0.83|0.56|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.56|-0.83|0.7107
71054697|NCT01338870|141613150|SUPERIORITY_OR_OTHER||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.352||0.1564|TWO_SIDED|95.0|-1.19|0.19|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.19|-1.19|0.1564
71054698|NCT01338870|141613150|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.345||0.3834|TWO_SIDED|95.0|-0.98|0.38|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.38|-0.98|0.3834
71054699|NCT01338870|141613150|SUPERIORITY_OR_OTHER||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.346||0.1279|TWO_SIDED|95.0|-1.21|0.15|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.15|-1.21|0.1279
71054700|NCT01338870|141613150|SUPERIORITY_OR_OTHER||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.339||0.252|TWO_SIDED|95.0|-1.06|0.28|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.28|-1.06|0.2520
71054701|NCT01338870|141613150|SUPERIORITY_OR_OTHER||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.336||0.2772|TWO_SIDED|95.0|-0.3|1.03|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.03|-0.30|0.2772
71054702|NCT01338870|141613150|SUPERIORITY_OR_OTHER||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.335||0.7038|TWO_SIDED|95.0|-0.79|0.53|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.53|-0.79|0.7038
71054703|NCT01338870|141613150|SUPERIORITY_OR_OTHER||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.329||0.2031|TWO_SIDED|95.0|-1.07|0.23|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.23|-1.07|0.2031
71054704|NCT01338870|141613150|SUPERIORITY_OR_OTHER||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.33||0.6948|TWO_SIDED|95.0|-0.78|0.52|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.52|-0.78|0.6948
71054705|NCT01338870|141613150|SUPERIORITY_OR_OTHER||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.421||0.5691|TWO_SIDED|95.0|-1.07|0.59|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.59|-1.07|0.5691
71054706|NCT01338870|141613150|SUPERIORITY_OR_OTHER||LS mean difference|0.39|STANDARD_ERROR_OF_MEAN|0.415||0.3447|TWO_SIDED|95.0|-0.42|1.21|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.21|-0.42|0.3447
71054707|NCT01338870|141613150|SUPERIORITY_OR_OTHER||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.413||0.5769|TWO_SIDED|95.0|-1.04|0.58|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.58|-1.04|0.5769
71054708|NCT01338870|141613150|SUPERIORITY_OR_OTHER||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.402||0.3599|TWO_SIDED|95.0|-1.16|0.42|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.42|-1.16|0.3599
71054709|NCT01338870|141613150|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.407||0.46|TWO_SIDED|95.0|-1.1|0.5|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.50|-1.10|0.4600
71054710|NCT01338870|141613150|SUPERIORITY_OR_OTHER||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.504||0.4253|TWO_SIDED|95.0|-1.39|0.59|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.59|-1.39|0.4253
70941648|NCT04748445|141383934|OTHER||Slope|-0.07075|STANDARD_ERROR_OF_MEAN|8.409||0.4018|TWO_SIDED|90.0|-0.2101|0.0686|||Mixed Models Analysis|||EE\_Third Octave Band (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.06860|-0.2101|0.4018
71106705|NCT00427193|141720075|OTHER||Mean Difference (Net)|-5.9|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-6.5|-5.3|||Mixed Models Analysis|||Difference in change in Fat Mass between prescribed 25% Caloric Restriction (CR) and Ad Libitum (AL) at 12 and 24 months as measured by dual X-ray absorptiometry (DXA) using the Hologic 4500A, Delphi W or Discovery A, by a standardized protocol according to a standardized protocol. Fat Mass (FM) and Fat Free Mass (FFM) were determined for the whole body.||-5.3|-6.5|<0.001
70851371|NCT00669409|141190548|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-23.0|STANDARD_ERROR_OF_MEAN|10.86|||TWO_SIDED|95.0|-44.4|-1.5||||||Change at Week 4, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-1.5|-44.4|
70851372|NCT00669409|141190549|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-12.2|18.8||||||Change at Week 8, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||18.8|-12.2|
70851373|NCT00669409|141190549|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.4|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-27.0|4.1||||||Change at Week 8, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.1|-27.0|
70851374|NCT00669409|141190549|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|7.92|||TWO_SIDED|95.0|-17.4|13.9||||||Change at Week 8, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.9|-17.4|
70851375|NCT00669409|141190549|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|7.73|||TWO_SIDED|95.0|-24.8|5.8||||||Change at Week 8, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.8|-24.8|
70851376|NCT00669409|141190549|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.0|STANDARD_ERROR_OF_MEAN|10.25|||TWO_SIDED|95.0|-39.2|1.3||||||Change at Week 8, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.3|-39.2|
70851377|NCT00669409|141190549|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-10.6|20.6||||||Change at Week 8, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.6|-10.6|
70851378|NCT00669409|141190549|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-24.0|7.1||||||Change at Week 8, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.1|-24.0|
70851379|NCT00669409|141190549|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|8.06|||TWO_SIDED|95.0|-17.1|14.8||||||Change at Week 8, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||14.8|-17.1|
70851380|NCT00669409|141190549|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.2|STANDARD_ERROR_OF_MEAN|7.83|||TWO_SIDED|95.0|-24.6|6.3||||||Change at Week 8, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.3|-24.6|
70851381|NCT00669409|141190549|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-17.8|STANDARD_ERROR_OF_MEAN|10.3|||TWO_SIDED|95.0|-38.2|2.5||||||Change at Week 8, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.5|-38.2|
70851382|NCT00669409|141190549|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-18.3|14.6||||||Change at Week 8, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||14.6|-18.3|
70851383|NCT00669409|141190549|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-20.1|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-36.5|-3.6||||||Change at Week 8, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.6|-36.5|
70851384|NCT00669409|141190549|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-19.5|13.9||||||Change at Week 8, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.9|-19.5|
70851385|NCT00669409|141190549|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-10.9|STANDARD_ERROR_OF_MEAN|8.22|||TWO_SIDED|95.0|-27.1|5.4||||||Change at Week 8, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.4|-27.1|
70851386|NCT00669409|141190549|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-10.5|STANDARD_ERROR_OF_MEAN|10.86|||TWO_SIDED|95.0|-32.0|10.9||||||Change at Week 8, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.9|-32.0|
70851387|NCT00669409|141190550|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|13.0|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-2.5|28.6||||||Change at Week 13, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||28.6|-2.5|
70851388|NCT00669409|141190550|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-21.0|10.0||||||Change at Week 13, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.0|-21.0|
70851389|NCT00669409|141190550|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|7.92|||TWO_SIDED|95.0|-10.4|20.9||||||Change at Week 13, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.9|-10.4|
71106706|NCT00427193|141720076|OTHER||Mean Difference (Net)|-5.9|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-6.4|-5.3|||Mixed Models Analysis|||Comparison of change in FM in 2 groups over at 24 mos, controlling for site, sex, BMI group, and baseline FM. A repeated measures Mixed Model was employed for the analysis. For any outcome, Type I error was controlled using a hierarchical gatekeeping strategy testing, first, the GroupXTime interaction, and, if non-significant, the main effects of these two factors. Bonferroni corrections were employed for non-significant effects. All tests were at p\<0.05||-5.3|-6.4|<0.0001
71106707|NCT01463527|141720077|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.31|||||TWO_SIDED|95.0|0.17|0.57||||||Odds of intervention in capnography open group as compared to capnography blind group after adjusting of age and length of sedation.||0.57|0.17|
71106708|NCT01463527|141720078|SUPERIORITY|||||||0.3|||||||GEE (Generalized Estimating Equation)|||||||0.30
71106709|NCT05136170|141720079|SUPERIORITY|The following null hypothesis was defined on this endpoint: the proportion of patients reaching a value of Schirmer I test (without anaesthesia) \>10mm/5min at week 4 in cenegermin (rhNGF) was lower or equal than control. The null hypothesis was rejected if the associated primary analysis p-value was lower than 0.025.|Odds Ratio (OR)|8.498||||0.002|TWO_SIDED|95.0|2.165|33.356||P-value of treatment variable from logistic regression model on proportion of patients reaching a value of Schirmer I test (without anesthesia) \>10mm/5min|Regression, Logistic|||Analysis was based on logistic regression model with multiple imputation (MI) under a missing not at random (MNAR) mechanism using retrieve dropouts with proportion of patients reaching a value of Schirmer I test \> 10 mm/5 min at Week 4 as dependent variable, treatment, gender, age class and baseline Schirmer I test value as qualitative independent variables. Site was considered as random effects that vary randomly among patients.||33.356|2.165|0.002
71106710|NCT05136170|141720080|SUPERIORITY|The following null hypothesis is defined on this endpoint: the change from baseline (reduction) in the global SANDE score at week 12 in cenegermin is lower or equal than control. The null hypothesis is rejected if the associated primary analysis p-value is lower than 0.025.|Adjusted means difference|0.59||||0.89|TWO_SIDED|95.0|-7.801|8.981||P-value of adjusted means difference between treatments from the ANCOVA model on change from baseline in the global SANDE score.|ANCOVA|||Analysis was based on ANCOVA model with multiple imputation (MI) under a missing not at random (MNAR) mechanism using retrieve dropouts with change from baseline in the global SANDE score at Week 12 as dependent variable, treatment, gender, age class and baseline global SANDE score as qualitative independent variables. Site was considered as random effects that vary randomly among patients.||8.981|-7.801|0.890
71106711|NCT05136170|141720081|SUPERIORITY|Analysis was based on logistic regression model with multiple imputation (MI) under missing not at random (MNAR) using retrieve dropouts with proportion of patients reaching a value of Schirmer I test \>10 mm/5 min at Week 8 as dependent variable, treatment, gender, age class and baseline Schirmer I test value as qualitative independent variables. Site was considered as random effects that vary randomly among patients.|Odds Ratio (OR)|6.648||||0.022|TWO_SIDED|95.0|1.307|33.808|||Regression, Logistic|||This key secondary endpoint was analyzed by means of a logistic regression model with proportion of patients reaching a value of Schirmer I test \>10mm/5min at Week 8 as dependent variable, treatment, gender, age class and baseline Schirmer I test value as fixed effects and site as random effect.||33.808|1.307|0.022
71106712|NCT05136170|141720082|SUPERIORITY||Adjusted means difference|0.221||||0.962|TWO_SIDED|95.0|-8.934|9.377||P-value of adjusted means difference between treatments from the ANCOVA model on change from baseline in SANDE score for severity at Week 12.|ANCOVA|||Analysis was based on ANCOVA model with multiple imputation (MI) under missing not at random (MNAR) using retrieve dropouts with change from baseline in the severity SANDE score at Week 12 as dependent variable, treatment, gender, age class and baseline severity SANDE score as qualitative independent variables.Site was considered as random effects that vary randomly among patients.||9.377|-8.934|0.962
71106713|NCT05136170|141720083|SUPERIORITY||Adjusted means difference|0.164||||0.973|TWO_SIDED|95.0|-9.221|9.549||P-value of adjusted means difference between treatments from the ANCOVA model on change from baseline in SANDE score for frequency at Week 12.|ANCOVA|||Analysis was based on ANCOVA model with multiple imputation (MI) under missing not at random (MNAR) using retrieve dropouts with change from baseline in the frequency SANDE score at Week 12 as dependent variable, treatment, gender, age class and baseline frequency SANDE score as qualitative independent variables. Site was considered as random effects that vary randomly among patients.||9.549|-9.221|0.973
70932906|NCT06140290|141365881|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment G) without practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|97.98|||||TWO_SIDED|90.0|76.99|124.7|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||124.70|76.99|
71117615|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
71117616|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
71117617|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
71021804|NCT00106028|141551405|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.537||||0.6103|TWO_SIDED|95.0|-4.424|7.497|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||7.497|-4.424|0.6103
71021805|NCT00106028|141551406|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.554||||0.0808||95.0|-0.193|3.301|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||3.301|-0.193|0.0808
71021806|NCT00106028|141551407|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.498||||0.6466|TWO_SIDED|95.0|-1.648|2.644|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||2.644|-1.648|0.6466
71021807|NCT00106028|141551408|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.465||||0.7391|TWO_SIDED|95.0|-3.224|2.294|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||2.294|-3.224|0.7391
71021808|NCT00106028|141551409|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.333|||<|0.0001||95.0|5.258|15.408|||ANCOVA|LS Means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||15.408|5.258|<0.0001
71021809|NCT00106028|141551410|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.04||||1789|TWO_SIDED|95.0|-2.807|14.887|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||14.887|-2.807|01789
71021810|NCT00106028|141551411|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28||||0.9646|TWO_SIDED|95.0|-12.196|12.755|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||12.755|-12.196|0.9646
71021811|NCT00106028|141551412|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.494||||0.003||95.0|1.912|9.077|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||9.077|1.912|0.0030
71106714|NCT05136170|141720084|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|2.378||||0.52|TWO_SIDED|95.0|-4.869|9.625||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Daily Activities) at Week 4|Mixed Model for Repeated Measures|||QoL (Daily Activities) - Week 4||9.625|-4.869|0.52
71106715|NCT05136170|141720084|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|7.11||||0.073|TWO_SIDED|95.0|-0.653|14.873||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Daily Activities) at Week 12.|Mixed Model for Repeated Measures|||QoL (Daily Activities) - Week 12||14.873|-0.653|0.073
70932907|NCT06140290|141365882|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|88.72|||||TWO_SIDED|90.0|73.1|107.68|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||107.68|73.10|
70932908|NCT06140290|141365882|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment G) without practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|97.54|||||TWO_SIDED|90.0|78.74|120.83|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||120.83|78.74|
70932909|NCT06140290|141365883|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|94.14|||||TWO_SIDED|90.0|79.01|112.17|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||112.17|79.01|
70932910|NCT06140290|141365883|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment G) without practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|103.36|||||TWO_SIDED|90.0|86.04|124.16|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||124.16|86.04|
70932911|NCT02722434|141365898|SUPERIORITY|||||||0.1228|||||||Chi-squared|||||||0.1228
70932912|NCT02722434|141365899|SUPERIORITY|||||||0.004|||||||Fisher Exact|||||||0.004
70932913|NCT02722434|141365900|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||Sensory Subscale||||0.79
70932914|NCT02722434|141365900|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||Motor Subscale||||0.43
70932915|NCT02722434|141365900|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||Autonomic Subscale||||0.97
70932916|NCT00786864|141365915|SUPERIORITY_OR_OTHER||||||p=|0||95.0|||||ANCOVA|||||||p=0.001
70932917|NCT00786864|141365916|SUPERIORITY_OR_OTHER||||||p<|0||95.0|||||ANCOVA|||||||p<0.001
70932918|NCT00786864|141365917|SUPERIORITY_OR_OTHER||||||p<|0||95.0|||||ANCOVA|||||||p<0.001
71054711|NCT01338870|141613150|SUPERIORITY_OR_OTHER||LS mean difference|0.39|STANDARD_ERROR_OF_MEAN|0.497||0.4349|TWO_SIDED|95.0|-0.59|1.37|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.37|-0.59|0.4349
70932919|NCT00786864|141365918|SUPERIORITY_OR_OTHER||||||p<|0||95.0|||||ANCOVA|||||||p<0.01
70932920|NCT03442777|141365938|SUPERIORITY||Risk Ratio (RR)|0.64||||0.04|TWO_SIDED|95.0|0.41|0.99||controlled for type of ward (ICU/Non-ICU)|Cochran-Mantel-Haenszel|||||0.99|0.41|0.04
70932921|NCT04732000|141365958|OTHER||Median Difference (Final Values)|-0.1373||||0.549|TWO_SIDED|||||The a priori threshold for statistical significance is \< 0.05.|Mann Whitney test, 2-sided|||||||0.5490
70932922|NCT01767467|141365975|NON_INFERIORITY|The objective was met if the lower limit of the 95% CI of the Geometric Mean (GM) ratio (GSK1437173A vaccine over placebo) for anti-gE ELISA antibody concentrations at Month 2 was greater than (\>) 3.|Adjusted Geometric Mean Concentration|29.75|||<|0.0001|TWO_SIDED|95.0|21.09|41.96||The p-value is relative to the null hypothesis Ho: Vaccine / Placebo = 1|Repeated measurement model|||The objective aimed to evaluate anti-gE humoral immune responses at Month 2 following a two-dose administration of the GSK1437173A vaccine, as compared to placebo, in subjects with haematologic malignancies excluding subjects with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia.||41.96|21.09|<0.0001
70932923|NCT01787032|141365999|SUPERIORITY_OR_OTHER||Ratio|373.66|STANDARD_DEVIATION|13.2|||TWO_SIDED|90.0|346.029|403.507|||ANOVA|A bioequivalence acceptance range was not specified and no hypothesis was tested as the main focus was on estimation.|ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.|||403.507|346.029|
70932924|NCT01787032|141365999|SUPERIORITY_OR_OTHER||Ratio|266.94|STANDARD_DEVIATION|16.0|||TWO_SIDED|90.0|243.267|292.914|||ANOVA|A bioequivalence acceptance range was not specified and no hypothesis was tested as the main focus was on estimation.|ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.|||292.914|243.267|
70932925|NCT01787032|141366000|SUPERIORITY_OR_OTHER||Ratio|261.34|STANDARD_DEVIATION|37.3|||TWO_SIDED|90.0|211.692|322.633|||ANOVA|A bioequivalence acceptance range was not specified and no hypothesis was tested as the main focus was on estimation|ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.|||322.633|211.692|
70941649|NCT04748445|141383934|OTHER||Slope|1.658|STANDARD_ERROR_OF_MEAN|3.607||0.6466|TWO_SIDED|90.0|-4.319|7.635|||Mixed Models Analysis|||EE\_VLHR (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||7.635|-4.319|0.6466
71054712|NCT01338870|141613150|SUPERIORITY_OR_OTHER||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.492||0.6697|TWO_SIDED|95.0|-1.18|0.76|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.76|-1.18|0.6697
71021812|NCT00106028|141551413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.473||||0.6106|TWO_SIDED|95.0|-4.245|7.192|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||7.192|-4.245|0.6106
71021813|NCT00106028|141551414|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.315||||0.9372|TWO_SIDED|95.0|-7.598|8.229|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||8.229|-7.598|0.9372
71021814|NCT00106028|141551415|SUPERIORITY_OR_OTHER||Mean Difference (Net)|31.675|||<|0.0001||95.0|21.051|42.3|||ANCOVA|LS means and p-value are from ANCOVA model adjusted for baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||42.300|21.051|<0.0001
71021815|NCT00106028|141551416|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.029||||0.0793|TWO_SIDED|95.0|-1.667|29.726|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||29.726|-1.667|0.0793
71021816|NCT00106028|141551417|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.567|||<|0.0001||95.0|5.59|11.545|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||11.545|5.590|<0.0001
71021817|NCT00106028|141551418|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.315||||0.4575|TWO_SIDED|95.0|-10.477|23.107|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||23.107|-10.477|0.4575
71021818|NCT00106028|141551419|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.594||||0.0172||95.0|6.801|68.386|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||68.386|6.801|0.0172
71021819|NCT00106028|141551420|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.492||||0.9786|TWO_SIDED|95.0|-36.807|35.824|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||35.824|-36.807|0.9786
71054713|NCT01338870|141613150|SUPERIORITY_OR_OTHER||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.476||0.5501|TWO_SIDED|95.0|-1.22|0.65|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.65|-1.22|0.5501
71054714|NCT01338870|141613150|SUPERIORITY_OR_OTHER||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.484||0.4081|TWO_SIDED|95.0|-1.35|0.55|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.55|-1.35|0.4081
71054715|NCT02871492|141613155|SUPERIORITY|||||||0.4294|||||||Cochran-Mantel-Haenszel|||||||0.4294
71054716|NCT02256436|141613171|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98||||0.41648|TWO_SIDED|95.0|0.81|1.19||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||PFS - All Participants||1.19|0.81|0.41648
71054717|NCT02256436|141613172|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.00224|TWO_SIDED|95.0|0.59|0.91||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||OS - All Participants (Note: ECOG PS=Eastern Cooperative Oncology Group Performance Status)||0.91|0.59|0.00224
71054718|NCT02256436|141613173|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.26443|TWO_SIDED|95.0|0.68|1.24||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||PFS - PD-L1 positive participants||1.24|0.68|0.26443
71054719|NCT02256436|141613174|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.61||||0.00239|TWO_SIDED|95.0|0.43|0.86||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||OS - PD-L1 positive participants||0.86|0.43|0.00239
71054720|NCT02256436|141613175|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.89||||0.23958|TWO_SIDED|95.0|0.61|1.28||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||PFS - Strongly PD-L1 positive participants||1.28|0.61|0.23958
71106716|NCT05136170|141720084|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|-4.166||||0.317|TWO_SIDED|95.0|-12.322|3.989||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Feelings) at Week 4.|Mixed Model for Repeated Measures|||QoL (Feelings) - Week 4||3.989|-12.322|0.317
70851390|NCT00669409|141190550|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|7.73|||TWO_SIDED|95.0|-23.1|7.5||||||Change at Week 13, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.5|-23.1|
70851391|NCT00669409|141190550|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|10.25|||TWO_SIDED|95.0|-29.7|10.8||||||Change at Week 13, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.8|-29.7|
70851392|NCT00669409|141190550|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|14.3|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-1.3|29.8||||||Change at Week 13, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||29.8|-1.3|
71054721|NCT02256436|141613176|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57||||0.00483|TWO_SIDED|95.0|0.37|0.88||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||OS - Strongly PD-L1 positive participants||0.88|0.37|0.00483
71054722|NCT02256436|141613179|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|17.2||||0.00061|TWO_SIDED|95.0|6.8|29.4||One-sided p-value for testing H0: difference in %=0; H1: difference in %\>0|Miettinen & Nurminen method|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||ORR per RECIST 1.1 - Strongly PD-L1 Positive Participants||29.4|6.8|0.00061
71054723|NCT02256436|141613180|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|15.6||||0.00049|TWO_SIDED|95.0|6.5|25.7||One-sided p-value for testing H0: difference in %=0; H1: difference in %\>0|Miettinen & Nurminen method|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||ORR per RECIST 1.1 - PD-L1 Positive Participants||25.7|6.5|0.00049
71021820|NCT00106028|141551421|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.64||||0.5971|TWO_SIDED|95.0|-40.952|23.672|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||23.672|-40.952|0.5971
71021821|NCT00106028|141551422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.014||||0.4154||95.0|-1.442|3.47|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||3.470|-1.442|0.4154
71021822|NCT00106028|141551423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.884||||0.6404|TWO_SIDED|95.0|-2.855|4.623|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||4.623|-2.855|0.6404
71021823|NCT00106028|141551424|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.66||||0.4978|TWO_SIDED|95.0|-6.499|3.179|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||3.179|-6.499|0.4978
71021824|NCT00106028|141551425|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.534||||0.027||95.0|0.41|6.658|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||6.658|0.410|0.0270
71021825|NCT00106028|141551426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.065||||0.5925|TWO_SIDED|95.0|-2.868|4.998|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||4.998|-2.868|0.5925
71021826|NCT00106028|141551427|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.193||||0.684|TWO_SIDED|95.0|-4.604|6.991|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||6.991|-4.604|0.6840
71021827|NCT00106028|141551428|SUPERIORITY_OR_OTHER|||||||0.068||95.0|||||Fisher Exact|||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||||0.0680
71021828|NCT00106028|141551429|SUPERIORITY_OR_OTHER|||||||0.4121||95.0|||||Fisher Exact|||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||||0.4121
71054724|NCT02256436|141613181|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|10.0||||0.00068|TWO_SIDED|95.0|3.9|16.2||One-sided p-value for testing H0: difference in %=0; H1: difference in %\>0|Miettinen & Nurminen method|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||ORR per RECIST 1.1 - All Participants||16.2|3.9|0.00068
71054725|NCT02256436|141613182|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.07066|TWO_SIDED|95.0|0.53|1.11||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||PFS per mRECIST - Strongly PD-L1 Positive Participants||1.11|0.53|0.07066
71117618|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
70851393|NCT00669409|141190550|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-19.2|12.0||||||Change at Week 13, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.0|-19.2|
70851394|NCT00669409|141190550|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|6.8|STANDARD_ERROR_OF_MEAN|8.06|||TWO_SIDED|95.0|-9.1|22.8||||||Change at Week 13, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||22.8|-9.1|
70851395|NCT00669409|141190550|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-10.3|STANDARD_ERROR_OF_MEAN|7.83|||TWO_SIDED|95.0|-25.8|5.1||||||Change at Week 13, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.1|-25.8|
70851396|NCT00669409|141190550|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|10.3|||TWO_SIDED|95.0|-28.8|12.0||||||Change at Week 13, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.0|-28.8|
70851397|NCT00669409|141190550|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-9.5|23.4||||||Change at Week 13, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||23.4|-9.5|
70851398|NCT00669409|141190550|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-22.4|10.6||||||Change at Week 13, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.6|-22.4|
70851399|NCT00669409|141190550|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|12.2|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-4.5|28.9||||||Change at Week 13, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||28.9|-4.5|
70851400|NCT00669409|141190550|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|8.22|||TWO_SIDED|95.0|-25.2|7.2||||||Change at Week 13, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.2|-25.2|
70851401|NCT00669409|141190550|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|10.86|||TWO_SIDED|95.0|-22.4|20.5||||||Change at Week 13, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.5|-22.4|
70851402|NCT03583385|141190578|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|% Ratio of Geometric Means|103.42|||||TWO_SIDED|90.0|95.18|112.37||||||||112.37|95.18|
70851403|NCT03583385|141190579|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|% Ratio of Geometric Means|106.78|||||TWO_SIDED|90.0|98.99|115.19||||||||115.19|98.99|
70851404|NCT02191865|141190609|SUPERIORITY_OR_OTHER||ratio of the geometric means|215.39|STANDARD_DEVIATION|73.5|||TWO_SIDED|90.0|120.71|384.32|||ANOVA|Fixed effect: 'hepatic status'; indicated whether a subject with hepatic impairment or a healthy subject , Random effect: 'matched pair'.|Ratio of Child Pugh A (Test): Healthy Child Pugh A (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of AUC (0-inf) was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.||384.32|120.71|
70851405|NCT02191865|141190609|SUPERIORITY_OR_OTHER||Ratio of geometric means|867.13|STANDARD_DEVIATION|45.9|||TWO_SIDED|90.0|572.93|1312.41|||ANOVA|Fixed effect: 'hepatic status'; indicated whether a subject with hepatic impairment or a healthy subject , Random effect: 'matched pair'.|Ratio of Child Pugh B (Test): Healthy Child Pugh B (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of AUC (0-inf) was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.||1312.41|572.93|
70851406|NCT02191865|141190610|SUPERIORITY_OR_OTHER||ratio of the geometric means|221.76|STANDARD_DEVIATION|61.4|||TWO_SIDED|90.0|134.73|365.01|||ANOVA|Fixed effect: 'hepatic status'; indicated whether a subject with hepatic impairment or a healthy subject , Random effect: 'matched pair'.|Ratio of Child Pugh A (Test): Healthy Child Pugh A (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of Cmax was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.||365.01|134.73|
70854124|NCT01425463|141196323|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of the investigational drug (Ferrous (II) Glycine Sulphate Complex) to the reference drug (Polyferose) was concluded if the lower limit of the two-sided 95 % confidence interval was greater than -7.0 g/L.|LS-Mean of ANCOVA|-2.19|||||TWO_SIDED|95.0|-8.47|4.09||||||||4.09|-8.47|
71021829|NCT00106028|141551430|SUPERIORITY_OR_OTHER|||||||0.3658||95.0|||||Savage Exact Test|||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||||0.3658
71021830|NCT00106028|141551431|SUPERIORITY_OR_OTHER|||||||0.3408||95.0|||||Savage Exact Test|||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||||0.3408
71054726|NCT02256436|141613183|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.08745|TWO_SIDED|95.0|0.6|1.1||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||PFS per mRECIST - PD-L1 Positive Participants||1.10|0.60|0.08745
70932926|NCT01787032|141366000|SUPERIORITY_OR_OTHER||Ratio|213.39|STANDARD_DEVIATION|34.1|||TWO_SIDED|90.0|175.783|259.051|||ANOVA|A bioequivalence acceptance range was not specified and no hypothesis was tested as the main focus was on estimation.|ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.|||259.051|175.783|
70932927|NCT01787032|141366001|SUPERIORITY_OR_OTHER||Ratio|372.88|STANDARD_DEVIATION|13.1|||TWO_SIDED|90.0|345.456|402.477|||ANOVA|A bioequivalence acceptance range was not specified and no hypothesis was tested as the main focus was on estimation.|ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.|||402.477|345.456|
71021831|NCT00106028|141551434|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.534||||0.0253||95.0|0.31|0.922||All Fractures|Cox proportional hazards|Hazard Ratio and 95% CI based on Cox proportional hazards model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.922|0.310|0.0253
71021832|NCT00106028|141551434|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.534||||0.0253|TWO_SIDED|95.0|0.31|0.922||All Non-Vertebral Fractures|Cox Proportional Hazard|Hazard Ratio and 95% CI based on Cox proportional hazards model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.922|0.310|0.0253
71021833|NCT00106028|141551434|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.487||||0.0501|TWO_SIDED|95.0|0.25|0.95||Long Bone Non-Vertebral Fracture|Cox Proportional Hazards|Hazard Ratio and 95% CI based on Cox proportional hazards model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.950|0.250|0.0501
71021834|NCT00106028|141551434|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.608||||0.2141|TWO_SIDED|95.0|0.262|1.41||Other Non-Vertebral Fracture|Cox Proportional Hazard|Hazard Ratio and 95% CI based on Cox proportional hazards model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||1.410|0.262|0.2141
71021835|NCT00106028|141551435|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.584||||0.0416||95.0|0.348|0.98||All Fractures|Wald test|Hazard Ratio and 95% CI based on Anderson-Gill mean intensity model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.980|0.348|0.0416
71021836|NCT00106028|141551435|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.584||||0.0416|TWO_SIDED|95.0|0.348|0.98||Non-Vertebral Fracture|Wald Test|Hazard Ratio and 95% CI based on Anderson-Gill mean intensity model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.980|0.348|0.0416
71054727|NCT02256436|141613184|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.05328|TWO_SIDED|95.0|0.71|1.04||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||PFS per mRECIST - All Participants||1.04|0.71|0.05328
71054728|NCT02256436|141613185|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|21.5||||9e-05|TWO_SIDED|95.0|10.1|34.2||One-sided p-value for testing H0: difference in %=0; H1: difference in %\>0|Miettinen & Nurminen method|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||ORR per mRECIST - Strongly PD-L1 Positive Participants||34.2|10.1|0.00009
71054729|NCT02256436|141613186|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|21.0||||2e-05|TWO_SIDED|95.0|11.1|31.5||One-sided p-value for testing H0: difference in %=0; H1: difference in %\>0|Miettinen & Nurminen method|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||ORR per mRECIST - PD-L1 Positive Participants||31.5|11.1|0.00002
71054730|NCT02256436|141613187|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|13.8||||1e-05|TWO_SIDED|95.0|7.4|20.3||One-sided p-value for testing H0: difference in %=0; H1: difference in %\>0|Miettinen & Nurminen method|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||ORR per mRECIST - All Participants||20.3|7.4|0.00001
71054731|NCT01292226|141613223|SUPERIORITY_OR_OTHER|||||||0.4505||||||Free MPA, time 0 \[trough\]|ANOVA|Analysis of variance (ANOVA)||||||0.4505
71054732|NCT01292226|141613223|SUPERIORITY_OR_OTHER|||||||0.7322||||||Free MPA, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.7322
70932928|NCT01787032|141366001|SUPERIORITY_OR_OTHER||Ratio|266.56|STANDARD_DEVIATION|16.0|||TWO_SIDED|90.0|242.955|292.456|||ANOVA|A bioequivalence acceptance range was not specified and no hypothesis was tested as the main focus was on estimation.|ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.|||292.456|242.955|
71054733|NCT01292226|141613223|SUPERIORITY_OR_OTHER|||||||0.6798||||||Total MPA, time 0 \[trough\]|ANOVA|||||||0.6798
71054734|NCT01292226|141613223|SUPERIORITY_OR_OTHER|||||||0.541||||||Total MPA, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.5410
71054735|NCT01292226|141613224|SUPERIORITY_OR_OTHER|||||||0.3892||||||Free MPA, time 0 \[trough\]|ANOVA|||||||0.3892
71054736|NCT01292226|141613224|SUPERIORITY_OR_OTHER|||||||0.6564||||||Total MPA, time 0 \[trough\]|ANOVA|||||||0.6564
70932929|NCT02195232|141366028|OTHER|||||||0.92|||||||t-test, 2 sided|||||||0.92
70932930|NCT04035447|141366050|SUPERIORITY|||||||0.519|||||||t-test, 2 sided|||Satisfaction with Therapy (ST)||||0.519
70932931|NCT04035447|141366050|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||Satisfaction with Therapist (SWT)||||0.150
70932932|NCT04035447|141366050|SUPERIORITY|||||||0.309|||||||t-test, 2 sided|||Global Improvement (Item 13)||||0.309
71054737|NCT01292226|141613224|SUPERIORITY_OR_OTHER|||||||0.7772||||||Free MPA, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.7772
71054738|NCT01292226|141613224|SUPERIORITY_OR_OTHER|||||||0.0958||||||Total MPA, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.0958
71054739|NCT01292226|141613225|SUPERIORITY_OR_OTHER|||||||0.5796||||||Time 0 \[trough\]|ANOVA|||||||0.5796
71054740|NCT01292226|141613225|SUPERIORITY_OR_OTHER|||||||0.3428||||||Time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.3428
70932933|NCT04035447|141366052|SUPERIORITY|||||||0.696|||||||t-test, 2 sided|||||||0.696
71054741|NCT01292226|141613226|SUPERIORITY_OR_OTHER|||||||0.9372||||||Free MPA, time 0 \[trough\]|ANOVA|||||||0.9372
71054742|NCT01292226|141613226|SUPERIORITY_OR_OTHER|||||||0.9904||||||Total MPA, time 0 \[trough\]|ANOVA|||||||0.9904
71054743|NCT01292226|141613226|SUPERIORITY_OR_OTHER|||||||0.3658||||||Free MPA, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.3658
71054744|NCT01292226|141613226|SUPERIORITY_OR_OTHER|||||||0.2987||||||Total MPA, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.2987
71054745|NCT01292226|141613227|SUPERIORITY_OR_OTHER|||||||0.7455||||||time 0 \[trough\]|ANOVA|||||||0.7455
71054746|NCT01292226|141613227|SUPERIORITY_OR_OTHER|||||||0.8504||||||Time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.8504
71054747|NCT01292226|141613228|SUPERIORITY_OR_OTHER|||||||0.6847||||||IMPDH I, time 0 \[trough\]|ANOVA|||||||0.6847
71054748|NCT01292226|141613228|SUPERIORITY_OR_OTHER|||||||0.3184||||||IMPDH I, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.3184
71054749|NCT01292226|141613228|SUPERIORITY_OR_OTHER|||||||0.3862||||||IMPDH II, time 0 \[trough\]|ANOVA|||||||0.3862
71054750|NCT01292226|141613228|SUPERIORITY_OR_OTHER|||||||0.904||||||IMPDH II, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.9040
71054751|NCT01292226|141613228|SUPERIORITY_OR_OTHER|||||||0.0907||||||IMPDH activity, time 0 \[trough\]|ANOVA|||||||0.0907
71054752|NCT01292226|141613228|SUPERIORITY_OR_OTHER|||||||0.963||||||IMPDH activity, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.9630
71054753|NCT01292226|141613229|SUPERIORITY_OR_OTHER|||||||0.413||||||IMPDH I|ANOVA|||||||0.4130
71054754|NCT01292226|141613229|SUPERIORITY_OR_OTHER|||||||0.3823||||||IMPDH II|ANOVA|||||||0.3823
71054755|NCT01292226|141613230|SUPERIORITY_OR_OTHER|||||||0.0316||||||IMPDH I|ANOVA|||||||0.0316
71054756|NCT01292226|141613230|SUPERIORITY_OR_OTHER|||||||0.944||||||IMPDH II|ANOVA|||||||0.9440
71054757|NCT01292226|141613231|SUPERIORITY_OR_OTHER|||||||0.1328||||||IMPDH I|ANOVA|||||||0.1328
71054758|NCT01292226|141613231|SUPERIORITY_OR_OTHER|||||||0.576||||||IMPDH II|ANOVA|||||||0.5760
71054759|NCT01292226|141613232|SUPERIORITY_OR_OTHER|||||||0.7332||||||Free MPA|ANOVA|||||||0.7332
71054760|NCT01292226|141613232|SUPERIORITY_OR_OTHER|||||||0.2681||||||Total MPA|ANOVA|||||||0.2681
71054761|NCT01292226|141613232|SUPERIORITY_OR_OTHER|||||||0.7087||||||AUC MPA|ANOVA|||||||0.7087
71054762|NCT01292226|141613233|SUPERIORITY_OR_OTHER|||||||0.9432||||||Free MPA|ANOVA|||||||0.9432
71054763|NCT01292226|141613233|SUPERIORITY_OR_OTHER|||||||0.5177||||||Total MPA|ANOVA|||||||0.5177
71054764|NCT01292226|141613233|SUPERIORITY_OR_OTHER|||||||0.6398||||||AUC MPA|ANOVA|||||||0.6398
71054765|NCT01292226|141613234|SUPERIORITY_OR_OTHER|||||||0.0656||||||Free MPA|ANOVA|||||||0.0656
71054766|NCT01292226|141613234|SUPERIORITY_OR_OTHER|||||||0.0131||||||Total MPA|ANOVA|||||||0.0131
71054767|NCT01292226|141613234|SUPERIORITY_OR_OTHER|||||||0.0515||||||AUC MPA|ANOVA|||||||0.0515
71054768|NCT01844505|141613235|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|99.5|0.43|0.76|||Stratified Log Rank test||Stratified Cox proportional hazard model. Ratio of Nivolumab over Ipimlimumab.|||0.76|0.43|<0.0001
71054769|NCT01844505|141613235|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|99.5|0.31|0.57|||Stratified Log Rank test||Stratified Cox proportional hazard model. Ratio of Nivolumab+Ipilimumab over Ipilimumab.|||0.57|0.31|<0.0001
71054770|NCT01844505|141613236|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|98.0|0.5|0.78|||Log Rank|Log-rank Test stratified by PD-L1 status, BRAF status, and M stage at screening as entered into the Interactive Voice Response System (IVRS).|Stratified Cox proportional hazard model. Ratio of Nivolumab over Ipilimumab|||0.78|0.50|<0.0001
71054771|NCT01844505|141613236|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.55|||<|0.0001|TWO_SIDED|98.0|0.42|0.72|||Log Rank|Log-rank Test stratified by PD-L1 status, BRAF status, and M stage at screening as entered into the IVRS.|Stratified Cox proportional hazard model. Ratio of Nivolumab+Ipilimumab over Ipilimumab.|||0.72|0.42|<0.0001
71054772|NCT01844505|141613239|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.65|0.96|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab + Ipilimumab over Nivolumab.|||0.96|0.65|
71054773|NCT01844505|141613240|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.69|1.05|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab + Ipilimumab over Nivolumab.|||1.05|0.69|
70932934|NCT04035447|141366053|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||0.350
70932935|NCT04035447|141366054|SUPERIORITY|||||||0.274|||||||Fisher Exact|||Outcomes were compared at post-intervention visit: 3-month (A2) for intervention participants, 9-month (A4) for waitlist control participants.||||0.274
70932936|NCT04035447|141366055|SUPERIORITY|||||||0.6|||||||Fisher Exact|||Outcomes were compared at post-intervention visit: 3-month (A2) for intervention participants, 9-month (A4) for waitlist control participants.||||0.600
70932937|NCT04035447|141366056|SUPERIORITY||Mean Difference (Net)|1.5|STANDARD_DEVIATION|8.4||0.1848|||||||Wilcoxon (Mann-Whitney)|Effect size (Hedges' g) of 0.18||||||0.1848
70932938|NCT04035447|141366057|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_DEVIATION|8.4||0.6153|||||||Wilcoxon (Mann-Whitney)|Effect size (Hedges' g) of 0.07||||||0.6153
70932939|NCT04035447|141366058|SUPERIORITY||Mean Difference (Net)|4.6|STANDARD_DEVIATION|16.1||0.0563|||||||Wilcoxon (Mann-Whitney)|Effect size (Hedges' g) of 0.28||||||0.0563
70932940|NCT04035447|141366059|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_DEVIATION|1.8||0.0265|||||||Wilcoxon (Mann-Whitney)|Effect size (Hedges' g) of 0.31||||||0.0265
71054774|NCT01844505|141613241|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.59|||<|0.0001|TWO_SIDED|95.0|2.49|5.16|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel Test Stratified by PD-L1 Status, BRAF Status and M stage at screening as entered into the IVRS. Ratio of Nivolumab over Ipilimumab.|||5.16|2.49|<0.0001
71054775|NCT01844505|141613241|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.35|||<|0.0001|TWO_SIDED|95.0|4.38|9.22|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel Test Stratified by PD-L1 Status, BRAF Status and M stage at screening as entered into the IVRS. Ratio of Nivolumab + Ipilimumab over Ipilimumab.|||9.22|4.38|<0.0001
71054776|NCT01844505|141613241|SUPERIORITY_OR_OTHER_LEGACY||Difference of Objective Response Rates|26.0|||||TWO_SIDED|95.0|19.1|32.8|||||Difference in ORR and corresponding 95% CI is based on Cochran-Mantel-Haenszel (CMH) method of weighting, adjusting for PD-L1 Status, BRAF Mutation Status and M-stage at screening as entered into the IVRS. Difference of Nivolumab - Ipilimumab.|||32.8|19.1|
71054777|NCT01844505|141613241|SUPERIORITY_OR_OTHER_LEGACY||Difference of Objective Response Rates|39.0|||||TWO_SIDED|95.0|32.2|45.9|||||Difference in ORR and corresponding 95% CI is based on CMH method of weighting, adjusting for PD-L1 Status, BRAF Mutation Status and M-stage at screening as entered into the IVRS. Difference of Nivolumab and Ipilimumab - Ipilimumab.|||45.9|32.2|
71054778|NCT01844505|141613241|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.75|||||TWO_SIDED|95.0|1.26|2.42|||||Cochran-Mantel-Haenszel Test Stratified by PD-L1 Status, BRAF Status and M stage at screening as entered into the IVRS. Ratio of Nivolumab + Ipilimumab over Nivolumab|||2.42|1.26|
70932941|NCT04035447|141366059|SUPERIORITY||Mean Difference (Net)|0.5|STANDARD_DEVIATION|2.6||0.2084|||||||Wilcoxon (Mann-Whitney)|Effect size (Hedges' g) of 0.18||||||0.2084
70932942|NCT04035447|141366060|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_DEVIATION|9.4||0.3512|||||||Wilcoxon (Mann-Whitney)|Effect size (Hedges' g) of -0.13||||||0.3512
70932943|NCT02130557|141366082|SUPERIORITY||Odds Ratio (OR)|1.547||||0.01|TWO_SIDED|95.0|1.072|2.233||1-sided p-value based on CMH test for general association between treatment and response with stratification by sokal risk group (low, intermediate, high) and region (1-3) at time of randomization. Statistical significance threshold: 1-sided 0.025.|Cochran-Mantel-Haenszel||95% Confidence Interval (CI) for the odds ratio adjusted for sokal risk group and region are based on Mantel-Haenszel confidence limits.|A total sample size of 500 Ph+ participants is required for the study to provide \>= 90% power to detect at least 15% difference (assuming 25% in the imatinib vs 40% in the bosutinib arm) in the MMR rates at 12 months (48 weeks) with a 1-sided alpha of 2.5%, and 2 interim futility analyses at 33% and 66% of patients with adequate follow-up with early stopping for futility only (non-binding, O'Brien-Fleming analog beta spending function).||2.233|1.072|0.0100
70932944|NCT02130557|141366083|SUPERIORITY||Odds Ratio (OR)|1.418||||0.0303|TWO_SIDED|95.0|0.986|2.037||1-sided p-value based on CMH test for general association between treatment and response with stratification by sokal risk group (low, intermediate, high) and region (1-3) at time of randomization. Statistical significance threshold: 1-sided 0.0125.|Cochran-Mantel-Haenszel||95% CI for the odds ratio adjusted for sokal risk group and region are based on Mantel-Haenszel confidence limits.|If the primary analysis was significant, each member of the short-term family (CCyR by Month 12, MMR by Month 18) was tested via Bonferroni's procedure at the 1-sided level of 0.0125.||2.037|0.986|0.0303
71054779|NCT01844505|141613241|SUPERIORITY_OR_OTHER_LEGACY||Difference of Objective Response Rates|13.2|||||TWO_SIDED|95.0|5.7|20.7|||||Difference in ORR and corresponding 95% CI is based on CMH method of weighting, adjusting for PD-L1 Status, BRAF Mutation Status and M-stage at screening as entered into the IVRS. Difference of Nivolumab and Ipilimumab - Nivolumab.|||20.7|5.7|
71054780|NCT01844505|141613242|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.46|0.85|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \< 1%|||0.85|0.46|
71054781|NCT01844505|141613242|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.39|||||TWO_SIDED|95.0|0.28|0.54|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \< 1%|||0.54|0.28|
71054782|NCT01844505|141613242|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.45|0.87|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \< 1%|||0.87|0.45|
71054783|NCT01844505|141613242|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.34|0.59|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \>= 1%|||0.59|0.34|
71054784|NCT01844505|141613242|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.3|0.53|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \>= 1%|||0.53|0.30|
71054785|NCT01844505|141613242|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.66|1.21|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \>= 1%|||1.21|0.66|
71054786|NCT01844505|141613242|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.45|0.71|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \< 5%|||0.71|0.45|
71054787|NCT01844505|141613242|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.42|||||TWO_SIDED|95.0|0.33|0.53|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \< 5%|||0.53|0.33|
71054788|NCT01844505|141613242|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.57|0.94|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \< 5%|||0.94|0.57|
71054789|NCT01844505|141613242|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.27|0.6|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \>= 5%|||0.60|0.27|
71054790|NCT01844505|141613242|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.35|||||TWO_SIDED|95.0|0.22|0.54|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \>= 5%|||0.54|0.22|
71054791|NCT01844505|141613242|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.54|1.38|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \>= 5%|||1.38|0.54|
71054792|NCT01844505|141613242|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.43|0.67|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \< 10%|||0.67|0.43|
71054793|NCT01844505|141613242|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.43|||||TWO_SIDED|95.0|0.34|0.54|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \< 10%|||0.54|0.34|
71054794|NCT01844505|141613242|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.63|1.01|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \< 10%|||1.01|0.63|
71054795|NCT01844505|141613242|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.28|0.73|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \>= 10%|||0.73|0.28|
71054796|NCT01844505|141613242|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.28|||||TWO_SIDED|95.0|0.16|0.49|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \>= 10%|||0.49|0.16|
71054797|NCT01844505|141613242|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.34|1.09|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \>= 10%|||1.09|0.34|
71054798|NCT01844505|141613242|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.49|1.52|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression not evaluable at baseline|||1.52|0.49|
71054799|NCT01844505|141613242|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.3|0.89|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression not evaluable at baseline|||0.89|0.30|
71054800|NCT01844505|141613242|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.33|1.09|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression not evaluable at baseline|||1.09|0.33|
71054801|NCT01844505|141613243|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.57|1.05|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \< 1%|||1.05|0.57|
71054802|NCT01844505|141613243|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.43|0.81|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \< 1%|||0.81|0.43|
71054803|NCT01844505|141613243|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||||95.0|0.55|1.04|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \< 1%|||1.04|0.55|
71054804|NCT01844505|141613243|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.52|||||TWO_SIDED|95.0|0.39|0.68|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \>= 1%|||0.68|0.39|
71054805|NCT01844505|141613243|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.5|||||TWO_SIDED|95.0|0.38|0.67|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \>= 1%|||0.67|0.38|
71054806|NCT01844505|141613243|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.72|1.31|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \>= 1%|||1.31|0.72|
71054807|NCT01844505|141613243|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.49|0.78|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \< 5%|||0.78|0.49|
71054808|NCT01844505|141613243|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.52|||||TWO_SIDED|95.0|0.41|0.66|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \< 5%|||0.66|0.41|
71054809|NCT01844505|141613243|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.66|1.08|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \< 5%|||1.08|0.66|
71054810|NCT01844505|141613243|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.41|0.91|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \>= 5%|||0.91|0.41|
71054811|NCT01844505|141613243|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.38|0.91|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \>= 5%|||0.91|0.38|
71054812|NCT01844505|141613243|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.62|1.53|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \>= 5%|||1.53|0.62|
71054813|NCT01844505|141613243|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.48|0.75|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \< 10%|||0.75|0.48|
71054814|NCT01844505|141613243|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.43|0.68|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \< 10%|||0.68|0.43|
71054815|NCT01844505|141613243|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.71|1.14|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \< 10%|||1.14|0.71|
71054816|NCT01844505|141613243|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.44|1.1|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \>= 10%|||1.10|0.44|
71054817|NCT01844505|141613243|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.32|0.91|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \>= 10%|||0.91|0.32|
71054818|NCT01844505|141613243|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.45|1.32|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \>= 10%|||1.32|0.45|
71054819|NCT01844505|141613243|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.37|1.34|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression not evaluable at baseline|||1.34|0.37|
71054820|NCT01844505|141613243|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.48|||||TWO_SIDED|95.0|0.26|0.91|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression not evaluable at baseline|||0.91|0.26|
70932945|NCT02130557|141366084|SUPERIORITY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.49|2.44|||||Hazard ratio (95% CIs) are based on the treatment effect (Bosutinib compared with Imatinib) in a stratified (by Sokal risk group at randomization and region) Cox proportional hazards model for the hazard of the respective event.|The medians have not been reached in either arm, as such, the premature estimated hazard ratio is provided.||2.44|0.49|
70932946|NCT02130557|141366085|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0037|TWO_SIDED|95.0|1.16|2.61||1-sided p-value based on CMH test for general association between treatment and response with stratification by sokal risk group (low, intermediate, high) and region (1-3) at time of randomization. Statistical significance threshold: 1-sided 0.0125.|Cochran-Mantel-Haenszel||95% CI for the odds ratio adjusted for sokal risk group and region are based on Mantel-Haenszel confidence limits.|If the primary analysis was significant, each member of the short-term family (CCyR by Month 12, MMR by Month 18) was tested via Bonferroni's procedure at the 1-sided level of 0.0125.||2.610|1.160|0.0037
70932947|NCT02130557|141366086|SUPERIORITY||Hazard Ratio (HR)|0.39|||||TWO_SIDED|95.0|0.14|1.13|||||Hazard ratio (95% CIs) are based on the treatment effect (Bosutinib compared with Imatinib) in a stratified (by Sokal risk group at randomization and region) Cox proportional hazards model for the hazard of the respective event.|The medians have not been reached in either arm, as such, the premature estimated hazard ratio is provided.||1.13|0.14|
70932948|NCT02130557|141366087|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.0749|TWO_SIDED|95.0|0.35|1.17||1-sided p-value based on Gray's test for comparing cumulative incidence function between treatment arms stratified by sokal risk group (low, intermediate, high) and region (1-3). Statistical significance threshold: 1-sided 0.0125.|Gray's test||The hazard ratio (95% CIs) are based on the proportional subdistribution hazards model stratified by Sokal risk group and region.|If each member of the short-term family (CCyR by Month 12, MMR by Month 18) was significant, EFS and OS were tested sequentially via the Holm's testing procedure at the 1-sided family wise level of 0.025. If one member of the short-term family was significant, EFS and OS were tested sequentially at 1-sided 0.0125.||1.17|0.35|0.0749
70932949|NCT02130557|141366088|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.2827|TWO_SIDED|95.0|0.37|1.73||1-sided p-value based on log-rank test for comparing survival curves between treatment arms stratified by sokal risk group and region. OS was not tested as EFS was not significant.|Log Rank||The hazard ratio (95% CIs) are based on the treatment effect (Bosutinib compared with Imatinib) in a stratified (by Sokal risk group at randomization and region) Cox proportional hazards model for the hazard of the respective event.|If each member of the short-term family (CCyR by Month 12, MMR by Month 18) was significant, EFS and OS were tested sequentially via the Holm's testing procedure at the 1-sided family wise level of 0.025. If one member of the short-term family was significant, EFS and OS were tested sequentially at 1-sided 0.0125.||1.73|0.37|0.2827
70932950|NCT03044158|141366116|SUPERIORITY||Rate Ratio (adjusted)|1.56|||||TWO_SIDED|95.0|1.21|2.01||||||||2.01|1.21|
71106717|NCT05136170|141720084|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixedmodel for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall"|LS means difference|1.058||||0.792|TWO_SIDED|95.0|-6.786|8.901||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Feelings) at Week 12.|Mixed Model for Repeated Measures|||QoL (Feelings) - Week 12||8.901|-6.786|0.792
71106718|NCT05136170|141720084|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM). Analyses included the fixed, categorical effects of treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall. Missing data will be imputed according to the questionnaire manuals"|LS means difference|-3.907||||0.488|TWO_SIDED|95.0|-14.948|7.135||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Work) at Week 4.|Mixed Model for Repeated Measures|||QoL (Work) - Week 4||7.135|-14.948|0.488
71106719|NCT05136170|141720084|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|-0.284||||0.954|TWO_SIDED|95.0|-9.998|9.431||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Work) at Week 12.|Mixed Model for Repeated Measures|||QoL (Work) - Week 12||9.431|-9.998|0.954
70932951|NCT03044158|141366117|SUPERIORITY||Rate Ratio (adjusted)|1.28|||||TWO_SIDED|95.0|0.99|1.66||||||||1.66|0.99|
70932952|NCT03044158|141366118|SUPERIORITY||Geometric Mean Ratio (adjusted)|0.49|||||TWO_SIDED|95.0|0.39|0.62||||||||0.62|0.39|
70932953|NCT03044158|141366119|SUPERIORITY||Rate Ratio (adjusted)|1.48|||||TWO_SIDED|95.0|1.04|2.12||||||||2.12|1.04|
70932954|NCT03044158|141366120|SUPERIORITY||Geometric Mean Ratio (adjusted)|0.35|||||TWO_SIDED|95.0|0.21|0.56||||||||0.56|0.21|
70932955|NCT03044158|141366121|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.44|1.35||||||||1.35|0.44|
70932956|NCT05613907|141366130|SUPERIORITY||Mean Difference (Net)|-21.6|STANDARD_ERROR_OF_MEAN|5.885||0.005|TWO_SIDED|95.0|-37.05|-6.15|||ANOVA|||||-6.150|-37.050|0.005
70932957|NCT05613907|141366130|SUPERIORITY||Mean Difference (Net)|-17.8|STANDARD_ERROR_OF_MEAN|6.512||0.04|TWO_SIDED|95.0|-34.895|-0.705|||ANOVA|||||-0.705|-34.895|0.040
70932958|NCT05613907|141366130|SUPERIORITY||Mean Difference (Net)|3.8|STANDARD_ERROR_OF_MEAN|3.668||0.94|TWO_SIDED|95.0|-5.829|13.429|||ANOVA|||||13.429|-5.829|0.940
70932959|NCT05613907|141366131|SUPERIORITY||Z statistic|-0.862||||0.388|TWO_SIDED||||||Wilcoxon Signed Ranks|||The null hypothesis is that there will be no significant difference in the EuroQol 5-D domains at 1 year compared to baseline.||||0.388
70932960|NCT05613907|141366132|SUPERIORITY||Z statistic|-0.033||||0.974|TWO_SIDED||||||Wilcoxon signed rank|||The null hypothesis is that there will be no statistical difference in patient self-reported ability to perform basic self-care||||0.974
70932961|NCT05613907|141366133|SUPERIORITY||Z statistic|-1.564||||0.118|TWO_SIDED||||||Wilcoxon signed rank|||The null hypothesis is no improvement in ability to perform usual activities at 1 year.||||0.118
71021837|NCT00106028|141551435|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.543||||0.0799|TWO_SIDED|95.0|0.274|1.076||Long Bone Non-Vertebral Fracture|Wald Test|Hazard Ratio and 95% CI based on Anderson-Gill mean intensity model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||1.076|0.274|0.0799
71021838|NCT00106028|141551435|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.682||||0.682|TWO_SIDED|95.0|0.304|1.532||Other Non-Vertebral Fracture|Wald Test|Hazard Ratio and 95% CI based on Anderson-Gill mean intensity model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||1.532|0.304|0.682
71021839|NCT00106028|141551436|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.678||||0.0318||95.0|-22.325|-1.031|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||-1.031|-22.325|0.0318
71054821|NCT01844505|141613243|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.34|1.39|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression not evaluable at baseline|||1.39|0.34|
71054822|NCT00468650|141613250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.96|STANDARD_DEVIATION|5.19|<|0.001||95.0|10.0|11.93||"Statistical significance will be declared if the p-value is \<0.05.~Change from Baseline: Week 6 (LOCF) minus Baseline"|t-test, 2 sided|single sample t-test||Primary hypothesis to be tested is whether there is a significant improvement in the IIEF EF domain at the end of the 100 mg period, as compared to the baseline (Week 0) score. Sample size (N=115) provides more than 90% power to detect a change from baseline of 10 in the primary efficacy variable, assuming a standard deviation of 9, using the two-sided, single-sample t-test with significance level (alpha) of 0.05.||11.93|10.00|<0.001
71054823|NCT00468650|141613251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.14|STANDARD_DEVIATION|5.21|<|0.001||95.0|6.17|8.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||8.11|6.17|<0.001
71054824|NCT00468650|141613251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.57|STANDARD_DEVIATION|5.43|<|0.001||95.0|9.56|11.59||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||11.59|9.56|<0.001
71054825|NCT00468650|141613251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.93|STANDARD_DEVIATION|5.26|<|0.001||95.0|9.93|11.92||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||11.92|9.93|<0.001
71054826|NCT00468650|141613251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.95|STANDARD_DEVIATION|5.21|<|0.001||95.0|9.97|11.92||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 endpoint minus baseline||11.92|9.97|<0.001
71054827|NCT00468650|141613252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.48|STANDARD_DEVIATION|3.97|<|0.001||95.0|2.74|4.23||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||4.23|2.74|<0.001
71054828|NCT00468650|141613252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.88|STANDARD_DEVIATION|4.38|<|0.001||95.0|3.05|4.71||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2 For the secondary outcome, the change in IIEF-EF domain from the end of 50 mg period (Week 2) to the end of 100 mg period (Week 6), the sample size (N=115) provides more than 80% power to detect a mean change of 1.75 points, assuming a standard deviation of 6, using the two-sided, single sample t-test with significance level (alpha) of 0.05||4.71|3.05|<0.001
71054829|NCT00468650|141613252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.86|STANDARD_DEVIATION|4.35|<|0.001||95.0|3.04|4.67||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2 For the secondary outcome, the change in IIEF-EF domain from the end of 50 mg period (Week 2) to the end of 100 mg period (Week 6), the sample size (N=115) provides more than 80% power to detect a mean change of 1.75 points, assuming a standard deviation of 6, using the two-sided, single sample t-test with significance level (alpha) of 0.05||4.67|3.04|<0.001
71054830|NCT00468650|141613252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.86|STANDARD_DEVIATION|4.35|<|0.001||95.0|3.04|4.67||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2 For the secondary outcome, the change in IIEF-EF domain from the end of 50 mg period (Week 2) to the end of 100 mg period (Week 6), the sample size (N=115) provides more than 80% power to detect a mean change of 1.75 points, assuming a standard deviation of 6, using the two-sided, single sample t-test with significance level (alpha) of 0.05||4.67|3.04|<0.001
71054831|NCT00468650|141613253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.89|STANDARD_DEVIATION|2.4|<|0.001||95.0|1.45|2.34||p-value not adjusted for multiple comparisons. Threshold for significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||2.34|1.45|<0.001
71054832|NCT00468650|141613253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.46|STANDARD_DEVIATION|2.32|<|0.001||95.0|2.02|2.89||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||2.89|2.02|<0.001
71054833|NCT00468650|141613253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.59|STANDARD_DEVIATION|2.44|<|0.001||95.0|2.13|3.05||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||3.05|2.13|<0.001
71054834|NCT00468650|141613253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.63|STANDARD_DEVIATION|2.45|<|0.001||95.0|2.17|3.08||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||3.08|2.17|<0.001
71054835|NCT00468650|141613253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.59|STANDARD_DEVIATION|2.42|<|0.001||95.0|2.14|3.04||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||3.04|2.14|<0.001
71054836|NCT00468650|141613254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.61|STANDARD_DEVIATION|1.51|<|0.001||95.0|0.32|0.89||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||0.89|0.32|<0.001
71054837|NCT00468650|141613254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.75|STANDARD_DEVIATION|1.46|<|0.001||95.0|0.47|1.02||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||1.02|0.47|<0.001
71054838|NCT00468650|141613254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.74|STANDARD_DEVIATION|1.45|<|0.001||95.0|0.47|1.01||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||1.01|0.47|<0.001
71054839|NCT00468650|141613254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.74|STANDARD_DEVIATION|1.45|<|0.001||95.0|0.47|1.01||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||1.01|0.47|<0.001
71054840|NCT00468650|141613255|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.43|STANDARD_DEVIATION|1.87|<|0.001||95.0|1.09|1.78||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||1.78|1.09|<0.001
71054841|NCT00468650|141613255|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.0|STANDARD_DEVIATION|1.86|<|0.001||95.0|1.65|2.35||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||2.35|1.65|<0.001
71054842|NCT00468650|141613255|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.25|STANDARD_DEVIATION|1.91|<|0.001||95.0|1.89|2.62||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||2.62|1.89|<0.001
70932962|NCT05613907|141366134|SUPERIORITY||Z statistic|-2.364||||0.018|TWO_SIDED||||||Wilcoxon signed rank|||||||0.018
71106720|NCT05136170|141720084|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEl module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|-0.049||||0.99|TWO_SIDED|95.0|-7.658|7.559||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL DE Treatment Satisfaction \& Bother module (Satisfaction with Treatment Effectiveness) at Week 4.|Mixed Model for Repeated Measures|||TS (Treatment - in general) - Week 4||7.559|-7.658|0.99
71106721|NCT05136170|141720084|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM)adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|1.976||||0.582|TWO_SIDED|95.0|-5.065|9.017||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL DE Treatment Satisfaction \& Bother module (Satisfaction with Treatment Effectiveness) at Week 12.|Mixed Model for Repeated Measures|||TS (Treatment - in general) - Week 12||9.017|-5.065|0.582
71106722|NCT05136170|141720084|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|5.232||||0.125|TWO_SIDED|95.0|-1.457|11.922||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL DE Symptom Bother Module at Week 4.|Mixed Model for Repeated Measures|||Symptom - Bother - Week 4||11.922|-1.457|0.125
71106723|NCT05136170|141720084|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|-0.156||||0.964|TWO_SIDED|95.0|-6.912|6.6||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL DE Symptom Bother Module at Week 12.|Mixed Model for Repeated Measures|||Symptom - Bother - Week 12||6.6|-6.912|0.964
71106724|NCT05136170|141720085|SUPERIORITY||LS means difference|0.795||||0.102|TWO_SIDED|95.0|-0.157|1.748||P-value of LS means difference between treatments from the MMRM on change from baseline at Week 4.|Mixed Model for Repeated Measures|||"Analysis was based on MMRM with Multiple Imputation under missing not at random using retrieve dropouts with change from baseline in TFBUT at each timepoint adjusting by gender, age class, TFBUT scale baseline value, treatment, visit, and treatment by visit interaction. Patient was considered as a random effect and the covariance matrix used was unstructured.~Herein analysis for Week 4 was reported."||1.748|-0.157|0.102
71106725|NCT05136170|141720085|SUPERIORITY||LS means difference|-0.051||||0.923|TWO_SIDED|95.0|-1.094|0.991||P-value of LS means difference between treatments from the MMRM on change from baseline at Week 8.|Mixed Model for Repeated Measures|||"Analysis was based on MMRM with Multiple Imputation under missing not at random using retrieve dropouts with change from baseline in TFBUT at each timepoint adjusting by gender, age class, TFBUT scale baseline value, treatment, visit, and treatment by visit interaction. Patient was considered as a random effect and the covariance matrix used was unstructured.~Herein analysis for Week 8 was reported."||0.991|-1.094|0.923
71106726|NCT05136170|141720085|SUPERIORITY||LS means difference|0.136||||0.787|TWO_SIDED|95.0|-0.849|1.12||P-value of LS means difference between treatments from the MMRM on change from baseline at Week 12|Mixed Model for Repeated Measures|||"Analysis was based on MMRM with Multiple Imputation under missing not at random using retrieve dropouts with change from baseline in TFBUT at each timepoint adjusting by gender, age class, TFBUT scale baseline value, treatment, visit, and treatment by visit interaction. Patient was considered as a random effect and the covariance matrix used was unstructured.~Herein analysis for Week 12 was reported."||1.12|-0.849|0.787
71106727|NCT05136170|141720086|SUPERIORITY||||||<|0.001||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 4 (Visit 3) was reported.||||<0.001
71106728|NCT05136170|141720086|SUPERIORITY||||||<|0.001||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 8 (Visit 4) was reported.||||<0.001
70932963|NCT05613907|141366135|SUPERIORITY||Z statistic|-1.311||||0.19|TWO_SIDED|||||The null hypothesis is that there will be no difference in anxiety and/or depression compared to the initial visit.|Wilcoxon signed rank|||||||0.190
71106729|NCT05136170|141720086|SUPERIORITY|||||||0.014||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 12 (Visit 5) was reported.||||0.014
71106730|NCT05136170|141720086|SUPERIORITY|||||||0.095||||||Not statistically significant result. p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 16 (Visit 6) was reported.||||0.095
71106731|NCT05136170|141720087|SUPERIORITY|||||||0.02||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 4 (Visit 3) was reported.||||0.02
71106732|NCT05136170|141720087|SUPERIORITY|||||||0.328||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 8 (Visit 4) was reported.||||0.328
71106733|NCT05136170|141720087|SUPERIORITY|||||||0.287||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 12 (Visit 5) was reported.||||0.287
70932964|NCT05613907|141366136|SUPERIORITY||Mean Difference (Net)|-26.846|STANDARD_ERROR_OF_MEAN|8.604||0.027|TWO_SIDED|95.0|-50.762|-2.39|||ANOVA|||||-2.390|-50.762|0.027
70932965|NCT05613907|141366136|SUPERIORITY||Mean Difference (Net)|-27.615|STANDARD_ERROR_OF_MEAN|8.715||0.024|TWO_SIDED|95.0|-51.837|-3.394|||ANOVA|||||-3.394|-51.837|0.024
70932966|NCT05613907|141366136|SUPERIORITY||Mean Difference (Net)|-0.769|STANDARD_ERROR_OF_MEAN|4.535||1|TWO_SIDED|95.0|-13.374|11.836|||ANOVA|||||11.836|-13.374|1.000
71106734|NCT05136170|141720087|SUPERIORITY|||||||0.777||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 16 (Visit 6) was reported.||||0.777
71106735|NCT05136170|141720088|SUPERIORITY|||||||0.126||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 4 (Visit 3) was reported.||||0.126
71106736|NCT05136170|141720088|SUPERIORITY|||||||0.968||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Week 8 (Visit 4) was reported.||||0.968
71106737|NCT05136170|141720088|SUPERIORITY|||||||0.613||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Week 12 (Visit 5) was reported.||||0.613
71106738|NCT05136170|141720088|SUPERIORITY|||||||0.805||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Week 16 (Visit 6) was reported.||||0.805
70932967|NCT05613907|141366137|SUPERIORITY||Mean Difference (Net)|-14.27|STANDARD_ERROR_OF_MEAN|4.052||0.048|TWO_SIDED|95.0|-37.05|-6.15|||ANOVA|||||-6.150|-37.050|0.048
70932968|NCT05613907|141366137|SUPERIORITY||Median Difference (Final Values)|-3.12|STANDARD_ERROR_OF_MEAN|3.751||1|TWO_SIDED|95.0|-12.893|13.751|||ANOVA|||||13.751|-12.893|1.000
70932969|NCT05613907|141366137|SUPERIORITY||Mean Difference (Net)|12.26|STANDARD_ERROR_OF_MEAN|5.186||0.163|TWO_SIDED|95.0|-4.762|29.333|||ANOVA|||||29.333|-4.762|0.163
70932970|NCT01958021|141366208|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.556||||3.29e-06|TWO_SIDED|95.0|0.429|0.72|||Log Rank|||||0.720|0.429|0.00000329
70932971|NCT01958021|141366209|SUPERIORITY||Hazard Ratio (HR)|0.765||||0.004|TWO_SIDED|95.0|0.628|0.932|||Log Rank|||||0.932|0.628|0.004
70932972|NCT01958021|141366210|SUPERIORITY_OR_OTHER_LEGACY|||||||0.000155|||||||Cochran-Mantel-Haenszel|||||||0.000155
70932973|NCT01958021|141366211|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||Cochran-Mantel-Haenszel|||||||0.018
71106739|NCT05136170|141720089|SUPERIORITY|||||||0.543||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Global score - Week 8 (Visit 4) was reported.||||0.543
71106740|NCT05136170|141720089|SUPERIORITY|||||||0.677||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Global score - Week 12 (Visit 5) was reported.||||0.677
71106741|NCT05136170|141720089|SUPERIORITY|||||||0.914||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Global score - Week 16 (Visit 6) was reported.||||0.914
71106742|NCT05136170|141720089|SUPERIORITY|||||||0.874||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Severity - Week 8 (Visit 4) was reported.||||0.874
71106743|NCT05136170|141720089|SUPERIORITY|||||||0.945||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Severity - Week 12 (Visit 5) was reported.||||0.945
71106744|NCT05136170|141720089|SUPERIORITY|||||||0.727||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Severity - Week 16 (Visit 6) was reported.||||0.727
71106745|NCT05136170|141720089|SUPERIORITY|||||||0.342||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Frequency - Week 8 (Visit 4) was reported.||||0.342
71106746|NCT05136170|141720089|SUPERIORITY|||||||0.821||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Frequency - Week 12 (Visit 5) was reported.||||0.821
70932974|NCT04640974|141366216|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
70932975|NCT04640974|141366217|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
70932976|NCT04640974|141366218|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
70932977|NCT04484623|141366221|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.37|0.73||P-Value presented to 3 decimal places from one-sided stratified Log-Rank test adjusting for the number of lines of prior therapy (1 vs. 2/3 vs. \>=4) and prior bortezomib (yes or no) according to IVRS strata.|Log Rank||Hazard ratio was estimated using a Cox Proportional Hazards model stratified by the number of lines of prior therapy (1 vs. 2/3 vs. \>=4) and prior bortezomib (yes or no) according to IVRS strata with a covariate of treatment.|||0.73|0.37|<0.001
70932978|NCT04649047|141366250|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|-2.92||||0.036|TWO_SIDED|95.0|-5.6|-0.23|||t-test, 2 sided|||||-0.23|-5.6|0.036
70932979|NCT04649047|141366251|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|-0.56||||-0.77|TWO_SIDED|95.0|-1.02|-0.1|||t-test, 2 sided|||||-0.10|-1.02|-0.77
70932980|NCT04649047|141366252|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|-3.42||||-0.51|TWO_SIDED|95.0|-7.69|0.85|||t-test, 2 sided|||||0.85|-7.69|-0.51
71106747|NCT05136170|141720089|SUPERIORITY|||||||0.926||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Frequency - Week 16 (Visit 6) was reported.||||0.926
71106748|NCT05136170|141720090|SUPERIORITY|||||||0.0344||||||p-value corresponds to Chi-square test of the comparisons between Cenegermin and Vehicle in all patients.|Chi-squared|||Herein analysis for Worsening in symptom scores (SANDE global score) - Week 4 (Visit 3) was reported.||||0.0344
71106749|NCT05136170|141720090|SUPERIORITY|||||||1||||||p-value corresponds to a Fisher's exact test of the comparisons between Cenegermin and Vehicle in all patients.|Fisher Exact|||Herein analysis for NEI score \>= 50% - Week 4 (Visit 3) was reported.||||1
71106750|NCT05136170|141720090|SUPERIORITY|||||||0.0235||||||p-value corresponds to Chi-square test of the comparisons between Cenegermin and Vehicle in all patients.|Chi-squared|||Herein analysis for Worsening in symptom scores and/or NEI score \>= 50 - Week 4 (Visit 3) was reported.||||0.0235
71106751|NCT05136170|141720091|SUPERIORITY|||||||0.888||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for QoL (Impact on Daily Activities) - Week 4 (Visit 3) was reported.||||0.888
71106752|NCT05136170|141720091|SUPERIORITY|||||||0.651||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for QoL (Impact on Daily Activities) - Week 8 (Visit 4) was reported.||||0.651
70932981|NCT04649047|141366253|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|0.85||||0.49|TWO_SIDED|95.0|-0.32|2.03|||t-test, 2 sided|||||2.03|-0.32|0.49
71106753|NCT05136170|141720091|SUPERIORITY|||||||0.267||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Impact on Daily Activities) - Week 12 (Visit 5) was reported.||||0.267
71106754|NCT05136170|141720091|SUPERIORITY|||||||0.459||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Impact on Daily Activities) - Week 16 (Visit 6) was reported.||||0.459
71106755|NCT05136170|141720091|SUPERIORITY|||||||0.192||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for QoL (Emotional Impact due to Dry Eye) - Week 4 was reported.||||0.192
71106756|NCT05136170|141720091|SUPERIORITY|||||||0.568||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for QoL (Emotional Impact due to Dry Eye) - Week 8 was reported.||||0.568
71106757|NCT05136170|141720091|SUPERIORITY|||||||0.871||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Emotional Impact due to Dry Eye) - Week 12 was reported.||||0.871
71106758|NCT05136170|141720091|SUPERIORITY|||||||0.85||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for QoL (Emotional Impact due to Dry Eye) - Week 16 was reported.||||0.85
71106759|NCT05136170|141720091|SUPERIORITY|||||||0.364||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Impact on Work due to Dry Eye) - Week 4 was reported.||||0.364
71106760|NCT05136170|141720091|SUPERIORITY|||||||0.646||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Impact on Work due to Dry Eye) - Week 8 was reported.||||0.646
71106761|NCT05136170|141720091|SUPERIORITY|||||||0.739||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Impact on Work due to Dry Eye) - Week 12 was reported.||||0.739
71106762|NCT05136170|141720091|SUPERIORITY|||||||0.664||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Impact on Work due to Dry Eye) - Week 16 was reported.||||0.664
71106763|NCT05136170|141720091|SUPERIORITY|||||||0.846||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for TS (Satisfaction with Effectiveness) - Week 4 was reported.||||0.846
71106764|NCT05136170|141720091|SUPERIORITY|||||||0.248||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for TS (Satisfaction with Effectiveness) - Week 8 was reported.||||0.248
70932982|NCT04649047|141366254|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|-8.54||||-0.48|TWO_SIDED|95.0|-19.9|2.82|||t-test, 2 sided|||||2.82|-19.9|-0.48
71106765|NCT05136170|141720091|SUPERIORITY|||||||0.341||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for TS (Satisfaction with Effectiveness) - Week 12 was reported.||||0.341
70932983|NCT04649047|141366255|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|64.46||||0.13|TWO_SIDED|95.0|-256.0|384.7|||t-test, 2 sided|||||384.7|-256|0.13
71054843|NCT00468650|141613255|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.26|STANDARD_DEVIATION|1.94|<|0.001||95.0|1.9|2.62||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||2.62|1.90|<0.001
71054844|NCT00468650|141613255|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.28|STANDARD_DEVIATION|1.93|<|0.001||95.0|1.91|2.64||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||2.64|1.91|<0.001
71106766|NCT05136170|141720091|SUPERIORITY|||||||0.413||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients|t-test, 2 sided|||Herein analysis for TS (Satisfaction with Effectiveness) - Week 16 was reported.||||0.413
71054845|NCT00468650|141613256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.55|STANDARD_DEVIATION|1.41|<|0.001||95.0|0.29|0.82||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||0.82|0.29|<0.001
71054846|NCT00468650|141613256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.81|STANDARD_DEVIATION|1.47|<|0.001||95.0|0.53|1.09||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||1.09|0.53|<0.001
71054847|NCT00468650|141613256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.83|STANDARD_DEVIATION|1.49|<|0.001||95.0|0.55|1.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||1.11|0.55|<0.001
71054848|NCT00468650|141613256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.83|STANDARD_DEVIATION|1.49|<|0.001||95.0|0.55|1.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||1.11|0.55|<0.001
71054849|NCT00468650|141613257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.18|STANDARD_DEVIATION|2.42|<|0.001||95.0|2.73|3.63||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||3.63|2.73|<0.001
71054850|NCT00468650|141613257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.38|STANDARD_DEVIATION|2.39|<|0.001||95.0|3.94|4.83||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||4.83|3.94|<0.001
71054851|NCT00468650|141613257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.73|STANDARD_DEVIATION|2.53|<|0.001||95.0|4.25|5.21||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||5.21|4.25|<0.001
71054852|NCT00468650|141613257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.7|STANDARD_DEVIATION|2.52|<|0.001||95.0|4.23|5.17||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||5.17|4.23|<0.001
71054853|NCT00468650|141613257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.72|STANDARD_DEVIATION|2.52|<|0.001||95.0|4.25|5.19||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||5.19|4.25|<0.001
71054854|NCT00468650|141613258|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.2|STANDARD_DEVIATION|2.1|<|0.001||95.0|0.8|1.59||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||1.59|0.80|<0.001
71054855|NCT00468650|141613258|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.54|STANDARD_DEVIATION|2.2|<|0.001||95.0|1.12|1.95||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||1.95|1.12|<0.001
71054856|NCT00468650|141613258|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.54|STANDARD_DEVIATION|2.19|<|0.001||95.0|1.13|1.95||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||1.95|1.13|<0.001
71054857|NCT00468650|141613258|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.54|STANDARD_DEVIATION|2.19|<|0.001||95.0|1.13|1.95||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||1.95|1.13|<0.001
71054858|NCT00468650|141613259|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.73|STANDARD_DEVIATION|2.38|<|0.001||95.0|2.28|3.17||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||3.17|2.28|<0.001
71054859|NCT00468650|141613259|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.67|STANDARD_DEVIATION|2.49|<|0.001||95.0|3.2|4.14||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||4.14|3.20|<0.001
71054860|NCT00468650|141613259|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.92|STANDARD_DEVIATION|2.52|<|0.001||95.0|3.44|4.4||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||4.40|3.44|<0.001
71054861|NCT00468650|141613259|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.91|STANDARD_DEVIATION|2.53|<|0.001||95.0|3.44|4.38||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||4.38|3.44|<0.001
71054862|NCT00468650|141613259|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.89|STANDARD_DEVIATION|2.53|<|0.001||95.0|3.42|4.37||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||4.37|3.42|<0.001
71054863|NCT00468650|141613260|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.97|STANDARD_DEVIATION|1.88|<|0.001||95.0|0.62|1.32||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||1.32|0.62|<0.001
71106767|NCT05136170|141720091|SUPERIORITY|||||||0.927||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for TS (Treatment Bother/Inconvenience) - Week 4 was reported.||||0.927
70932984|NCT04649047|141366256|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|3.5||||0.88|TWO_SIDED|95.0|0.98|6.02|||t-test, 2 sided|||||6.02|0.98|0.88
71106768|NCT05136170|141720091|SUPERIORITY|||||||0.914||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for TS (Treatment Bother/Inconvenience) - Week 8 was reported.||||0.914
71106769|NCT05136170|141720091|SUPERIORITY|||||||0.564||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for TS (Treatment Bother/Inconvenience) - Week 12 was reported.||||0.564
71106770|NCT05136170|141720091|SUPERIORITY|||||||0.489||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for TS (Treatment Bother/Inconvenience) - Week 16 was reported.||||0.489
71106771|NCT05136170|141720091|SUPERIORITY|||||||0.082||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Symptom-Bother - Week 4||||0.082
71106772|NCT05136170|141720091|SUPERIORITY|||||||0.848||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Symptom-Bother - Week 8 was reported.||||0.848
71106773|NCT05136170|141720091|SUPERIORITY|||||||0.805||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Symptom-Bother - Week 12 was reported.||||0.805
71106774|NCT05136170|141720091|SUPERIORITY|||||||0.833||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Symptom-Bother - Week 16 was reported.||||0.833
71106775|NCT05136170|141720094|SUPERIORITY||||||<|0.001||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||||||<0.001
71106776|NCT05136170|141720095|SUPERIORITY|||||||0.046||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||||||0.046
71106777|NCT05136170|141720096|SUPERIORITY|||||||0.34||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||||||0.34
71106778|NCT05136170|141720097|SUPERIORITY|||||||0.017||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Global Score - Week 2 was reported||||0.017
71106779|NCT05136170|141720097|SUPERIORITY|||||||0.339||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Global Score - Week 4 was reported||||0.339
71106780|NCT05136170|141720097|SUPERIORITY|||||||0.004||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Severity - Week 2 was reported.||||0.004
71106781|NCT05136170|141720097|SUPERIORITY|||||||0.292||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Severity - Week 4 was reported.||||0.292
70932985|NCT04649047|141366257|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|2.67||||0.61|TWO_SIDED|95.0|-0.1|4.94|||t-test, 2 sided|||||4.94|-0.10|0.61
70932986|NCT04649047|141366258|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|4.5||||0.78|TWO_SIDED|95.0|0.82|8.18|||t-test, 2 sided|||||8.18|0.82|0.78
70932987|NCT04649047|141366259|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|3.42||||0.58|TWO_SIDED|95.0|-0.32|7.16|||t-test, 2 sided|||||7.16|-0.32|0.58
70932988|NCT04649047|141366260|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|2.42||||0.61|TWO_SIDED|95.0|-0.1|4.94|||t-test, 2 sided|||||4.94|-0.10|0.61
71106782|NCT05136170|141720097|SUPERIORITY|||||||0.09||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Frequency - Week 2 was reported.||||0.09
71106783|NCT05136170|141720097|SUPERIORITY|||||||0.54||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Frequency - Week 4 was reported.||||0.54
71106784|NCT05136170|141720098|SUPERIORITY|||||||0.0064||||||p-value corresponds to Chi-square test of the comparisons between Cenegermin and Vehicle in all patients.|Chi-squared|||Herein analysis for Worsening in symptom scores (SANDE global score) was reported.||||0.0064
71106785|NCT05136170|141720098|SUPERIORITY|||||||1||||||p-value corresponds to a Fisher's exact test of the comparisons between Cenegermin and Vehicle in all patients.|Fisher Exact|||Herein analysis for NEI score \>= 50% was reported.||||1
71106786|NCT05136170|141720098|SUPERIORITY|||||||0.0034||||||p-value corresponds to Chi-square test of the comparisons between Cenegermin and Vehicle in all patients.|Chi-squared|||Herein analysis for Worsening in symptom scores and/or NEI score \>= 50 was reported.||||0.0034
71106787|NCT05136170|141720099|SUPERIORITY||||||<|0.001||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||||||<0.001
71106788|NCT01788943|141720101|OTHER|||||||0.037|||||||ANOVA|||||||0.037
71106789|NCT01788943|141720102|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
71054864|NCT00468650|141613260|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.21|STANDARD_DEVIATION|1.92|<|0.001||95.0|0.85|1.57||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||1.57|0.85|<0.001
71054865|NCT00468650|141613260|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.2|STANDARD_DEVIATION|1.9|<|0.001||95.0|0.84|1.55||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||1.55|0.84|<0.001
71054866|NCT00468650|141613260|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.2|STANDARD_DEVIATION|1.9|<|0.001||95.0|0.84|1.55||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||1.55|0.84|<0.001
71054867|NCT00468650|141613261|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|32.71|STANDARD_DEVIATION|25.36|<|0.001||95.0|27.98|37.43||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||37.43|27.98|<0.001
71054868|NCT00468650|141613261|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|46.21|STANDARD_DEVIATION|26.27|<|0.001||95.0|41.29|51.12||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||51.12|41.29|<0.001
71054869|NCT00468650|141613261|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|45.53|STANDARD_DEVIATION|26.96|<|0.001||95.0|40.44|50.63||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||50.63|40.44|<0.001
71106790|NCT04846231|141720149|SUPERIORITY||Mean Difference (Net)|35.22|||<|0.001|TWO_SIDED|95.0|29.13|41.32|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05. This belongs to the primary endpoint.||41.32|29.13|<0.001
70932989|NCT04649047|141366261|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|3.83||||0.46|TWO_SIDED|95.0|-1.5|9.16|||t-test, 2 sided|||||9.16|-1.50|0.46
71054870|NCT00468650|141613261|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|45.28|STANDARD_DEVIATION|27.01|<|0.001||95.0|40.25|50.31||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||50.31|40.25|<0.001
71054871|NCT00468650|141613261|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|45.05|STANDARD_DEVIATION|27.02|<|0.001||95.0|39.99|50.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||50.11|39.99|<0.001
71054872|NCT00468650|141613262|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.84|STANDARD_DEVIATION|21.1|<|0.001||95.0|9.89|17.79||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||17.79|9.89|<0.001
71054873|NCT00468650|141613262|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.07|STANDARD_DEVIATION|24.25|<|0.001||95.0|8.49|17.65||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||17.65|8.49|<0.001
71054874|NCT00468650|141613262|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|12.69|STANDARD_DEVIATION|24.26|<|0.001||95.0|8.14|17.23||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||17.23|8.14|<0.001
71054875|NCT00468650|141613262|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|12.69|STANDARD_DEVIATION|24.26|<|0.001||95.0|8.14|17.23||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||17.23|8.14|<0.001
71054876|NCT00468650|141613263|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.41|STANDARD_DEVIATION|4.4|<|0.001||95.0|4.59|6.23||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||6.23|4.59|<0.001
71054877|NCT00468650|141613263|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|8.85|STANDARD_DEVIATION|4.96|<|0.001||95.0|7.92|9.78||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||9.78|7.92|<0.001
71054878|NCT00468650|141613263|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.21|STANDARD_DEVIATION|5.19|<|0.001||95.0|8.23|10.19||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||10.19|8.23|<0.001
71054879|NCT00468650|141613263|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.28|STANDARD_DEVIATION|5.14|<|0.001||95.0|8.32|10.24||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||10.24|8.32|<0.001
71054880|NCT00468650|141613263|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.25|STANDARD_DEVIATION|5.15|<|0.001||95.0|8.28|10.22||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||10.22|8.28|<0.001
71054881|NCT00468650|141613264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.51|STANDARD_DEVIATION|3.89|<|0.001||95.0|2.78|4.24||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||4.24|2.78|<0.001
71054882|NCT00468650|141613264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.91|STANDARD_DEVIATION|4.41|<|0.001||95.0|3.08|4.74||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||4.74|3.08|<0.001
71106791|NCT04846231|141720149|SUPERIORITY||Mean Difference (Net)|34.43|||<|0.001|TWO_SIDED|95.0|28.28|40.58|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.||40.58|28.28|<0.001
71054883|NCT00468650|141613264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.91|STANDARD_DEVIATION|4.38|<|0.001||95.0|3.09|4.73||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||4.73|3.09|<0.001
71054884|NCT00468650|141613264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.91|STANDARD_DEVIATION|4.38|<|0.001||95.0|3.09|4.73||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||4.73|3.09|<0.001
71054885|NCT00468650|141613265|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.68|STANDARD_DEVIATION|4.86|<|0.001||95.0|5.77|7.59||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||7.59|5.77|<0.001
71054886|NCT00468650|141613265|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.94|STANDARD_DEVIATION|5.21|<|0.001||95.0|8.96|10.91||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||10.91|8.96|<0.001
71054887|NCT00468650|141613265|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.59|STANDARD_DEVIATION|5.08|<|0.001||95.0|9.62|11.56||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||11.56|9.62|<0.001
71054888|NCT00468650|141613265|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.63|STANDARD_DEVIATION|5.03|<|0.001||95.0|9.68|11.58||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||11.58|9.68|<0.001
71054889|NCT00468650|141613265|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.64|STANDARD_DEVIATION|5.06|<|0.001||95.0|9.68|11.59||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||11.59|9.68|<0.001
71054890|NCT00468650|141613266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.29|STANDARD_DEVIATION|4.1|<|0.001||95.0|2.52|4.05||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||4.05|2.52|<0.001
71054891|NCT00468650|141613266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.03|STANDARD_DEVIATION|5.09|<|0.001||95.0|3.06|5.0||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||5.00|3.06|<0.001
71054892|NCT00468650|141613266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.01|STANDARD_DEVIATION|5.04|<|0.001||95.0|3.06|4.96||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||4.96|3.06|<0.001
71054893|NCT00468650|141613266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.01|STANDARD_DEVIATION|5.04|<|0.001||95.0|3.06|4.96||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||4.96|3.06|<0.001
71054894|NCT00468650|141613267|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.79|STANDARD_DEVIATION|2.44|<|0.001||95.0|2.33|3.24||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||3.24|2.33|<0.001
71054895|NCT00468650|141613267|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.23|STANDARD_DEVIATION|2.56|<|0.001||95.0|3.74|4.71||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||4.71|3.74|<0.001
71054896|NCT00468650|141613267|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.74|STANDARD_DEVIATION|2.84|<|0.001||95.0|4.2|5.28||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||5.28|4.20|<0.001
71054897|NCT00468650|141613267|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.78|STANDARD_DEVIATION|2.81|<|0.001||95.0|4.25|5.31||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||5.31|4.25|<0.001
71054898|NCT00468650|141613267|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.76|STANDARD_DEVIATION|2.82|<|0.001||95.0|4.23|5.3||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||5.30|4.23|<0.001
71054899|NCT00468650|141613268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.49|STANDARD_DEVIATION|1.91|<|0.001||95.0|1.13|1.85||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||1.85|1.13|<0.001
71054900|NCT00468650|141613268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.96|STANDARD_DEVIATION|2.08|<|0.001||95.0|1.57|2.36||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||2.36|1.57|<0.001
71054901|NCT00468650|141613268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.98|STANDARD_DEVIATION|2.07|<|0.001||95.0|1.59|2.37||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||2.37|1.59|<0.001
71106792|NCT04846231|141720149|SUPERIORITY||Mean Difference (Net)|38.27|||<|0.001|TWO_SIDED|95.0|32.2|44.34|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.||44.34|32.20|<0.001
71054902|NCT00468650|141613268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.98|STANDARD_DEVIATION|2.07|<|0.001||95.0|1.59|2.37||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||2.37|1.59|<0.001
71054903|NCT00468650|141613269|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|8.84|STANDARD_DEVIATION|28.7||0.0016||95.0|3.42|14.26||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||14.26|3.42|0.0016
71054904|NCT00468650|141613269|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.18|STANDARD_DEVIATION|27.51|<|0.001||95.0|4.93|15.43||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||15.43|4.93|<0.001
70932990|NCT04649047|141366262|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|4.08||||0.71|TWO_SIDED|95.0|0.43|7.73|||t-test, 2 sided|||||7.73|0.43|0.71
70932991|NCT04649047|141366263|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|-3.67||||-0.52|TWO_SIDED|95.0|-8.12|0.79|||t-test, 2 sided|||||0.79|-8.12|-0.52
70932992|NCT05037513|141366274|SUPERIORITY||Odds Ratio (OR)|7.06|||<|0.05|TWO_SIDED|95.0|0.8|62.2|||Regression, Logistic|||||62.2|0.8|<0.05
71106793|NCT04846231|141720149|SUPERIORITY||Mean Difference (Net)|42.98|||<|0.001|TWO_SIDED|95.0|37.02|48.95|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.||48.95|37.02|<0.001
71106794|NCT04846231|141720149|SUPERIORITY||Mean Difference (Final Values)|36.57|||<|0.001|TWO_SIDED|95.0|30.61|42.54|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.||42.54|30.61|<0.001
71106795|NCT04846231|141720149|SUPERIORITY||Mean Difference (Net)|33.49|||<|0.001|TWO_SIDED|95.0|27.42|39.55|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.||39.55|27.42|<0.001
71106796|NCT04846231|141720149|SUPERIORITY||Mean Difference (Net)|31.31|||<|0.001|TWO_SIDED|95.0|25.16|37.47|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.||37.47|25.16|<0.001
71106797|NCT04846231|141720151|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
71106798|NCT01448616|141720160|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.86||||0.086|TWO_SIDED|95.0|0.71|1.01||ITT|Poisson GLME|||For intent to treat analysis, difference between lead-in and treatment phase (within arm comparison)||1.01|0.71|0.086
70932993|NCT05037513|141366275|SUPERIORITY||Odds Ratio (OR)|7.06|||<|0.05|TWO_SIDED|95.0|0.8|62.2|||Regression, Logistic|||||62.2|0.8|<0.05
71106799|NCT01448616|141720160|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.94||||0.54|TWO_SIDED|95.0|0.75|1.16||For intent to treat analysis, difference between lead-in and treatment phase (within arm comparison)|Poisson GLME|||For intent to treat analysis, difference between lead-in and treatment phase (within arm comparison)||1.16|0.75|0.54
70932994|NCT05886777|141366282|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A and B as measured by NT: H0: ln(μ1)- ln(μ4) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, ln(μ1), ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 1, 4, respectively.|Geometric mean ratio|0.99|||||TWO_SIDED|97.5|0.782|1.249|||||GMRs and 2-sided confidence intervals (CIs) were calculated by exponentiating mean differences of logarithms of titers (Intervention Group \[Group 1\] minus Reference Group \[Group 4\]) and corresponding CIs (based on the Student t distribution).|||1.249|0.782|
70932995|NCT05886777|141366283|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A and B as measured by NT: H0: ln(μ1)- ln(μ4) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, ln(μ1), ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 1, 4, respectively.|Geometric mean ratio|0.9|||||TWO_SIDED|97.5|0.697|1.162|||||GMRs and 2-sided CIs were calculated by exponentiating mean differences of the logarithms of titers (Intervention Group \[Group 1\] minus Reference Group \[Group 4\]) and corresponding CIs (based on the Student t distribution).|||1.162|0.697|
70932996|NCT05886777|141366284|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 was evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT: H0: ln(μ1)- ln(μ3) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 1, 3, respectively.|Geometric mean ratio|0.84|||||TWO_SIDED|97.5|0.605|1.168|||||GMRs and 2-sided CIs were calculated by exponentiating mean differences of the logarithms of titers (Intervention Group \[Group 1\] minus Reference Group \[Group 3\]) and corresponding CIs (based on the Student t distribution).|||1.168|0.605|
71106800|NCT01448616|141720160|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.9||||0.47|TWO_SIDED|95.0|0.67|1.22|||Poisson GLME|||For intent to treat analysis, difference between lead-in and treatment phase (within arm comparison)||1.22|0.67|0.47
71106801|NCT01448616|141720161|SUPERIORITY_OR_OTHER_LEGACY||Change in log copies|-0.16||||0.18|TWO_SIDED|95.0|-0.4|0.07|||Linear Mixed Effects Model|||Intent to treat analysis||0.07|-0.40|0.18
71106802|NCT01448616|141720161|SUPERIORITY_OR_OTHER_LEGACY||Change in log copies|-0.5||||0.008|TWO_SIDED|95.0|-0.86|-0.13|||Linear Mixed Effects Model|||Intent to treat analysis||-0.13|-0.86|0.008
71106803|NCT01448616|141720161|SUPERIORITY_OR_OTHER_LEGACY||Change in log copies|0.16||||0.45|TWO_SIDED|95.0|-0.27|0.6|||Linear Mixed Effects Model|||Intent to treat analysis||0.60|-0.27|0.45
71106804|NCT01448616|141720162|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.98||||0.9|TWO_SIDED|95.0|0.7|1.37|||Poisson GLME|||Intent to treat analysis||1.37|0.70|0.90
71106805|NCT01448616|141720162|SUPERIORITY||Risk Ratio (RR)|0.8||||0.25|TWO_SIDED|95.0|0.54|1.18|||Poisson GLM|||Intent to treat||1.18|0.54|0.25
71021840|NCT00106028|141551437|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.067||||0.9907|TWO_SIDED|95.0|-11.401|11.536|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||11.536|-11.401|0.9907
71021841|NCT00106028|141551438|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.686||||0.3826|TWO_SIDED|95.0|-15.276|5.903|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||5.903|-15.276|0.3826
71021842|NCT00106028|141551439|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.629|||<|0.0001||95.0|-38.089|-15.169|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||-15.169|-38.089|<0.0001
71021843|NCT00106028|141551440|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.04||||0.3075|TWO_SIDED|95.0|-8.433|26.512|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||26.512|-8.433|0.3075
71021844|NCT00106028|141551441|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.039||||0.3998|TWO_SIDED|95.0|-16.849|6.772|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||6.772|-16.849|0.3998
71021845|NCT00106028|141551442|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.352||||0.1592||95.0|-0.845|0.14|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.140|-0.845|0.1592
71021846|NCT00106028|141551443|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.127||||0.2917||95.0|-0.111|0.365|||ANOVA|LS means and p-value are from ANOVA model with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.365|-0.111|0.2917
71021847|NCT00106028|141551444|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.007||||0.9622||95.0|-0.304|0.319|||ANOVA|LS mean and p-value are from ANOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.319|-0.304|0.9622
71054905|NCT00468650|141613269|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|12.29|STANDARD_DEVIATION|28.88|<|0.001||95.0|6.7|17.88||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||17.88|6.70|<0.001
71054906|NCT00468650|141613269|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|11.96|STANDARD_DEVIATION|28.33|<|0.001||95.0|6.61|17.32||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||17.32|6.61|<0.001
71054907|NCT00468650|141613269|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|11.95|STANDARD_DEVIATION|28.55|<|0.001||95.0|6.51|17.4||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||17.40|6.51|<0.001
71054908|NCT00468650|141613270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.37|STANDARD_DEVIATION|14.85||0.3324||95.0|-1.42|4.17||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||4.17|-1.42|0.3324
71054909|NCT00468650|141613270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.12|STANDARD_DEVIATION|14.26||0.0249||95.0|0.4|5.84||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||5.84|0.40|0.0249
71106806|NCT01448616|141720162|SUPERIORITY||Risk Ratio (RR)|0.95||||0.82|TWO_SIDED|95.0|0.57|1.57|||Poisson GLM|||||1.57|0.57|0.82
71106807|NCT01448616|141720163|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.74||||0.01|TWO_SIDED|95.0|0.59|0.92|||Poisson GLME|||Intent to Treat||0.92|0.59|0.010
71106808|NCT01448616|141720163|SUPERIORITY||Risk Ratio (RR)|1.3||||0.09|TWO_SIDED|95.0|0.9|1.76|||Poisson GLM|||||1.76|0.9|0.09
71106809|NCT01448616|141720163|SUPERIORITY||Risk Ratio (RR)|0.9||||0.47|TWO_SIDED|95.0|0.67|1.22|||Poisson GLM|||Intent to treat analysis||1.22|0.67|0.47
71106810|NCT01991860|141720164|SUPERIORITY|||||||0.033||||||2-sided|Chi-squared, Corrected|Yates's continuity correction||||||0.033
71106811|NCT01991860|141720165|SUPERIORITY|||||||0.16|||||||Chi-squared, Corrected|Yates's continuity correction||||||0.16
71106812|NCT01991860|141720166|SUPERIORITY|||||||0.68|||||||Chi-squared, Corrected|Yates's continuity correction||||||0.68
71106813|NCT01991860|141720167|SUPERIORITY|||||||0.026|||||||Chi-squared, Corrected|Yates's continuity correction||||||0.026
71106814|NCT01991860|141720168|SUPERIORITY|||||||0.086|||||||Chi-squared, Corrected|Yates's continuity correction||||||0.086
71106815|NCT01991860|141720169|SUPERIORITY|||||||0.074|||||||Chi-squared, Corrected|Yates's continuity correction||||||0.074
71106816|NCT01991860|141720170|SUPERIORITY|||||||0.15|||||||Chi-squared, Corrected|Yates's continuity correction||||||0.15
71106817|NCT00485173|141720178|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.|||||<|0.001||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||<0.001
71106818|NCT00485173|141720178|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||<0.001
70941650|NCT04748445|141383934|OTHER||Slope|1.172|STANDARD_ERROR_OF_MEAN|1.423||0.4118|TWO_SIDED|90.0|-1.186|3.53|||Mixed Models Analysis|||MM\_Cepstral Peak Prominence (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||3.530|-1.186|0.4118
71106819|NCT00485173|141720179|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.|||||<|0.001||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||<0.001
71106820|NCT00485173|141720179|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||0.002
71106821|NCT00485173|141720180|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||0.002
71106822|NCT00485173|141720181|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.|||||<|0.001||95.0||||P-value was one-sided from random sampling, based on covariance matrix produced by logistic regression using propensity score as a covariate.|Regression, Logistic|||||||<0.001
71106823|NCT00485173|141720181|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||0.011
71106824|NCT00485173|141720182|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||0.063
71106825|NCT00485173|141720183|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.|||||<|0.001||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||<0.001
71106826|NCT00485173|141720183|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||<0.001
71106827|NCT00485173|141720184|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||0.031
71106828|NCT00485173|141720185|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.||||||0.001||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||0.001
71106829|NCT00485173|141720185|SUPERIORITY_OR_OTHER|||||||0.414||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||0.414
71106830|NCT00485173|141720186|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||0.030
71106831|NCT00485173|141720187|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.|||||<|0.001||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||<0.001
71106832|NCT00485173|141720187|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||0.017
71106833|NCT00485173|141720188|SUPERIORITY_OR_OTHER|||||||0.189||95.0||||P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||0.189
71106834|NCT00485173|141720189|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.||||||0.003||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||0.003
71106835|NCT00485173|141720189|SUPERIORITY_OR_OTHER|||||||0.466||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||0.466
71106836|NCT00485173|141720190|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.|||||<|0.001||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||<0.001
71106837|NCT00485173|141720190|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||0.133
71106838|NCT00485173|141720191|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was two-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||<0.001
71106839|NCT00485173|141720192|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was two-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||<0.001
71106840|NCT00485173|141720193|SUPERIORITY_OR_OTHER|||||||0.341||95.0||||P-value was two-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||0.341
71106841|NCT00485173|141720194|SUPERIORITY_OR_OTHER|||||||0.479||95.0||||P-value was two-sided, obtained from Cox regression and adjusted with propensity scores.|Regression, Cox|||||||0.479
71106842|NCT00485173|141720195|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was from logistic regression model by using propensity score and any ossification 'Yes/No' at preop as the covariates.|Regression, Logistic|||Statistical analysis at 24 months postoperation.||||<0.001
71106843|NCT00829998|141720201|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|97.4||||||90.0|89.4|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106|89.4|
71106844|NCT00829998|141720202|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|102.0||||||90.0|97.1|107.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107|97.1|
71106845|NCT00829998|141720203|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|102.0||||||90.0|97.1|107.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107|97.1|
71106846|NCT00834197|141720204|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.59||||||90.0|95.76|105.65|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||105.65|95.76|
70932997|NCT05886777|141366285|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 was evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT: H0: ln(μ1)- ln(μ3) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 1, 3, respectively.|Geometric mean ratio|0.79|||||TWO_SIDED|97.5|0.618|1.014|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 1\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.014|0.618|
71106847|NCT00834197|141720205|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.17||||||90.0|94.82|101.65|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101.65|94.82|
71106848|NCT00834197|141720206|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.25||||||90.0|95.22|101.39|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101.39|95.22|
71106849|NCT04712669|141720207|SUPERIORITY||Mean Difference (Final Values)|57.27|STANDARD_ERROR_OF_MEAN|24.773||0.0208|TWO_SIDED|95.0|8.716|105.824||LSM, SE, CIs for each treatment group; LSM Diff, SE, CIs, and p-value are estimated using an ANCOVA model incl. factors for treatment group and randomization strata with associated baseline value as a covariate.|ANCOVA|H0: The mean change from baseline in PVR at Week 24 is equal between placebo and rodatristat ethyl.||||105.824|8.716|0.0208
71106850|NCT04712669|141720207|SUPERIORITY||Mean Difference (Final Values)|58.406|STANDARD_ERROR_OF_MEAN|24.558||0.0174|TWO_SIDED|95.0|10.272|106.54||LSM, SE, CIs for each treatment group; LSM Diff, SE, CIs, and p-value are estimated using an ANCOVA model incl. factors for treatment group and randomization strata with associated baseline value as a covariate.|ANCOVA|H0: The mean change from baseline in PVR at Week 24 is equal between placebo and rodatristat ethyl.||||106.54|10.272|0.0174
71106851|NCT04712669|141720208|SUPERIORITY|||||||0.573||||||P-value based on ordinal logistic regression with treatment group and randomization stratification strata as factors at alpha=0.05.|Regression, Logistic|H0: The distribution of change from baseline in WHO FC at Week 24 is equal between placebo and rodatristat ethyl.||||||0.573
71106852|NCT04712669|141720208|SUPERIORITY|||||||0.9911||||||P-value based on ordinal logistic regression with treatment group and randomization stratification strata as factors at alpha=0.05.|Regression, Logistic|H0: The distribution of change from baseline in WHO FC at Week 24 is equal between placebo and rodatristat ethyl.||||||0.9911
71106853|NCT04712669|141720209|SUPERIORITY||Median Difference (Final Values)|-33.61|STANDARD_ERROR_OF_MEAN|18.121||0.0636|TWO_SIDED|95.0|-69.13|1.91||p-value (alpha=0.05) is estimated using the aligned rank stratified Wilcoxon test with the randomization stratification factors as strata.|Wilcoxon (Mann-Whitney)|H0: The distribution of change from baseline at Week 24 in 6MWT distance (meters) is equal between placebo and rodatristat ethyl.||||1.91|-69.13|0.0636
71106854|NCT04712669|141720209|SUPERIORITY||Median Difference (Final Values)|-19.05|STANDARD_ERROR_OF_MEAN|13.469||0.1573|TWO_SIDED|95.0|-45.45|7.35||p-value (alpha=0.05) is estimated using the aligned rank stratified Wilcoxon test with the randomization stratification factors as strata.|Wilcoxon (Mann-Whitney)|H0: The distribution of change from baseline at Week 24 in 6MWT distance (meters) is equal between placebo and rodatristat ethyl.||||7.35|-45.45|0.1573
71054910|NCT00468650|141613270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.98|STANDARD_DEVIATION|13.95||0.0249||95.0|0.37|5.58||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||5.58|0.37|0.0249
71054911|NCT00468650|141613270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.04|STANDARD_DEVIATION|14.07||0.0249||95.0|0.39|5.68||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||5.68|0.39|0.0249
71054912|NCT00468650|141613271|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|15.37|STANDARD_DEVIATION|30.51|<|0.001||95.0|9.38|21.36||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||21.36|9.38|<0.001
71054913|NCT00468650|141613271|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|17.15|STANDARD_DEVIATION|32.22|<|0.001||95.0|10.76|23.55||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||23.55|10.76|<0.001
71054914|NCT00468650|141613271|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|18.22|STANDARD_DEVIATION|32.44|<|0.001||95.0|11.68|24.76||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||24.76|11.68|<0.001
71054915|NCT00468650|141613271|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|17.33|STANDARD_DEVIATION|31.87|<|0.001||95.0|11.07|23.59||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||23.59|11.07|<0.001
71054916|NCT00468650|141613271|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|17.68|STANDARD_DEVIATION|32.1|<|0.001||95.0|11.31|24.04||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||24.04|11.31|<0.001
71054917|NCT00468650|141613272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.46|STANDARD_DEVIATION|9.41||0.1061||95.0|-0.32|3.24||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||3.24|-0.32|0.1061
71054918|NCT00468650|141613272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.18|STANDARD_DEVIATION|12.33||0.3237||95.0|-1.18|3.54||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||3.54|-1.18|0.3237
71054919|NCT00468650|141613272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.13|STANDARD_DEVIATION|12.05||0.3236||95.0|-1.13|3.38||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||3.38|-1.13|0.3236
71054920|NCT00468650|141613272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.15|STANDARD_DEVIATION|12.16||0.3236||95.0|-1.15|3.45||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||3.45|-1.15|0.3236
71054921|NCT00468650|141613273|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|56.96|STANDARD_DEVIATION|38.93|<|0.001||95.0|49.31|64.6||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||64.60|49.31|<0.001
71054922|NCT00468650|141613273|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|70.78|STANDARD_DEVIATION|35.46|<|0.001||95.0|63.74|77.81||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||77.81|63.74|<0.001
71054923|NCT00468650|141613273|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|71.23|STANDARD_DEVIATION|35.79|<|0.001||95.0|64.02|78.45||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||78.45|64.02|<0.001
71054924|NCT00468650|141613273|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|72.15|STANDARD_DEVIATION|35.41|<|0.001||95.0|65.2|79.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||79.11|65.20|<0.001
71054925|NCT00468650|141613273|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|71.6|STANDARD_DEVIATION|35.55|<|0.001||95.0|64.54|78.65||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||78.65|64.54|<0.001
71054926|NCT00468650|141613274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.56|STANDARD_DEVIATION|30.89|<|0.001||95.0|7.72|19.4||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||19.40|7.72|<0.001
71054927|NCT00468650|141613274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.25|STANDARD_DEVIATION|31.31|<|0.001||95.0|8.25|20.25||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||20.25|8.25|<0.001
71054928|NCT00468650|141613274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.51|STANDARD_DEVIATION|31.77|<|0.001||95.0|8.56|20.46||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||20.46|8.56|<0.001
71054929|NCT00468650|141613274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.77|STANDARD_DEVIATION|32.0|<|0.001||95.0|8.72|20.82||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||20.82|8.72|<0.001
71054930|NCT00468650|141613275|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|58.58|STANDARD_DEVIATION|41.24|<|0.001||95.0|50.48|66.68||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||66.68|50.48|<0.001
70932998|NCT05886777|141366286|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 1,5, respectively.|Geometric mean ratio|1.06|||||TWO_SIDED|97.5|0.785|1.423|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 1\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||1.423|0.785|
70932999|NCT05886777|141366287|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 1,5, respectively.|Geometric mean ratio|1.13|||||TWO_SIDED|97.5|0.909|1.402|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 1\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||1.402|0.909|
70933000|NCT05886777|141366288|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 1,5, respectively.|Geometric mean ratio|1.05|||||TWO_SIDED|97.5|0.773|1.434|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 1\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||1.434|0.773|
70933001|NCT05886777|141366289|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 1,5, respectively.|Geometric mean ratio|1.11|||||TWO_SIDED|97.5|0.807|1.515|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 1\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||1.515|0.807|
71054931|NCT00468650|141613275|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|76.29|STANDARD_DEVIATION|37.21|<|0.001||95.0|68.9|83.67||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||83.67|68.90|<0.001
71054932|NCT00468650|141613275|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|77.69|STANDARD_DEVIATION|37.26|<|0.001||95.0|70.18|85.21||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||85.21|70.18|<0.001
71054933|NCT00468650|141613275|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|78.79|STANDARD_DEVIATION|36.65|<|0.001||95.0|71.59|85.99||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||85.99|71.59|<0.001
71054934|NCT00468650|141613275|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|78.36|STANDARD_DEVIATION|36.89|<|0.001||95.0|71.04|85.68||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||85.68|71.04|<0.001
71054935|NCT00468650|141613276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|17.9|STANDARD_DEVIATION|36.63|<|0.001||95.0|10.98|24.83||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||24.83|10.98|<0.001
71054936|NCT00468650|141613276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|19.5|STANDARD_DEVIATION|36.84|<|0.001||95.0|12.44|26.56||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||26.56|12.44|<0.001
71054937|NCT00468650|141613276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|19.52|STANDARD_DEVIATION|36.99|<|0.001||95.0|12.59|26.45||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||26.45|12.59|<0.001
71054938|NCT00468650|141613276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|19.88|STANDARD_DEVIATION|37.23|<|0.001||95.0|12.84|26.91||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||26.91|12.84|<0.001
71106855|NCT04712669|141720210|SUPERIORITY||Mean Difference (Final Values)|1125.9|STANDARD_ERROR_OF_MEAN|351.28||0.0014|TWO_SIDED|95.0|437.39|1814.39|||Mixed Models Analysis|H0: The mean change from baseline at Week 24 in NT-proBNP is equal between placebo and rodatristat ethyl.|Estimates from a REML MMRM with baseline covariate, fixed effects, and unstructured covariance.|||1814.39|437.39|0.0014
71106856|NCT04712669|141720210|SUPERIORITY||Mean Difference (Final Values)|866.3|STANDARD_ERROR_OF_MEAN|306.56||0.0047|TWO_SIDED|95.0|265.41|1467.16|||Mixed Models Analysis|H0: The mean change from baseline at Week 24 in NT-proBNP is equal between placebo and rodatristat ethyl.|Estimates from a REML MMRM with baseline covariate, fixed effects, and unstructured covariance.|||1467.16|265.41|0.0047
71106857|NCT01819272|141720211|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-9.0||||0.067|TWO_SIDED|95.0|-21.0|1.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||1.0|-21.0|0.0670
71054939|NCT00468650|141613277|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|57.34|STANDARD_DEVIATION|42.6|<|0.001||95.0|48.93|65.75||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||65.75|48.93|<0.001
71054940|NCT00468650|141613277|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|70.72|STANDARD_DEVIATION|40.3|<|0.001||95.0|62.72|78.71||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||78.71|62.72|<0.001
71054941|NCT00468650|141613277|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|70.63|STANDARD_DEVIATION|40.78|<|0.001||95.0|62.41|78.85||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||78.85|62.41|<0.001
71054942|NCT00468650|141613277|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|72.07|STANDARD_DEVIATION|40.27|<|0.001||95.0|64.16|79.98||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||79.98|64.16|<0.001
71054943|NCT00468650|141613277|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|71.51|STANDARD_DEVIATION|40.48|<|0.001||95.0|63.48|79.55||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||79.55|63.48|<0.001
71054944|NCT00468650|141613278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.1|STANDARD_DEVIATION|29.11|<|0.001||95.0|7.58|18.63||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||18.63|7.58|<0.001
71054945|NCT00468650|141613278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.11|STANDARD_DEVIATION|32.53|<|0.001||95.0|7.84|20.37||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||20.37|7.84|<0.001
71054946|NCT00468650|141613278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.47|STANDARD_DEVIATION|31.92|<|0.001||95.0|7.47|19.47||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||19.47|7.47|<0.001
71054947|NCT00468650|141613278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.72|STANDARD_DEVIATION|32.16|<|0.001||95.0|7.61|19.82||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||19.82|7.61|<0.001
71054948|NCT00468650|141613279|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|56.96|STANDARD_DEVIATION|38.93|<|0.001||95.0|49.31|64.6||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||64.60|49.31|<0.001
71054949|NCT00468650|141613279|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|70.78|STANDARD_DEVIATION|35.46|<|0.001||95.0|63.74|77.81||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||77.81|63.74|<0.001
71054950|NCT00468650|141613279|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|71.23|STANDARD_DEVIATION|35.79|<|0.001||95.0|64.02|78.45||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||78.45|64.02|<0.001
70941651|NCT04748445|141383934|OTHER||Slope|-1.282|STANDARD_ERROR_OF_MEAN|1.965||0.9481|TWO_SIDED|90.0|-3.385|3.129|||Mixed Models Analysis|||MM\_Harmonicity (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-2. For estimated value it was 10\^-3).||3.129|-3.385|0.9481
71054951|NCT00468650|141613279|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|72.15|STANDARD_DEVIATION|35.41|<|0.001||95.0|65.2|79.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||79.11|65.20|<0.001
71054952|NCT00468650|141613279|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|71.6|STANDARD_DEVIATION|35.55|<|0.001||95.0|64.54|78.65||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||78.65|64.54|<0.001
71054953|NCT00468650|141613280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.56|STANDARD_DEVIATION|30.89|<|0.001||95.0|7.72|19.4||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||19.40|7.72|<0.001
71054954|NCT00468650|141613280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.25|STANDARD_DEVIATION|31.31|<|0.001||95.0|8.25|20.25||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||20.25|8.25|<0.001
71054955|NCT00468650|141613280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.51|STANDARD_DEVIATION|31.77|<|0.001||95.0|8.56|20.46||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||20.46|8.56|<0.001
71054956|NCT00468650|141613280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.77|STANDARD_DEVIATION|32.0|<|0.001||95.0|8.72|20.82||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||20.82|8.72|<0.001
71054957|NCT00468650|141613281|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-12.58|STANDARD_DEVIATION|37.77||0.001||95.0|-19.96|-5.2||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||-5.20|-19.96|0.0010
71054958|NCT00468650|141613281|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-20.55|STANDARD_DEVIATION|35.04|<|0.001||95.0|-27.47|-13.64||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||-13.64|-27.47|<0.001
71054959|NCT00468650|141613281|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-22.53|STANDARD_DEVIATION|36.64|<|0.001||95.0|-29.88|-15.18||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||-15.18|-29.88|<0.001
71054960|NCT00468650|141613281|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-21.44|STANDARD_DEVIATION|36.06|<|0.001||95.0|-28.49|-14.39||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||-14.39|-28.49|<0.001
71054961|NCT00468650|141613281|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-21.86|STANDARD_DEVIATION|36.29|<|0.001||95.0|-29.03|-14.7||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||-14.70|-29.03|<0.001
71054962|NCT00468650|141613282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.79|STANDARD_DEVIATION|22.58||0.0021||95.0|-11.06|-2.52||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||-2.52|-11.06|0.0021
71054963|NCT00468650|141613282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.85|STANDARD_DEVIATION|23.02||0.0027||95.0|-11.26|-2.43||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||-2.43|-11.26|0.0027
71054964|NCT00468650|141613282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.43|STANDARD_DEVIATION|24.2||0.0015||95.0|-11.97|-2.9||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||-2.90|-11.97|0.0015
71054965|NCT00468650|141613282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.57|STANDARD_DEVIATION|24.4||0.0015||95.0|-12.18|-2.96||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||-2.96|-12.18|0.0015
71054966|NCT00468650|141613283|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-9.87|STANDARD_DEVIATION|34.44||0.0045||95.0|-16.6|-3.14||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||-3.14|-16.60|0.0045
71054967|NCT00468650|141613283|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-11.74|STANDARD_DEVIATION|32.8|<|0.001||95.0|-18.22|-5.27||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||-5.27|-18.22|<0.001
71054968|NCT00468650|141613283|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-12.78|STANDARD_DEVIATION|33.56|<|0.001||95.0|-19.51|-6.05||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||-6.05|-19.51|<0.001
71106858|NCT01819272|141720211|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-14.0||||0.0057|TWO_SIDED|95.0|-22.0|-4.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-4.0|-22.0|0.0057
71106859|NCT01819272|141720211|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-12.0||||0.1095|TWO_SIDED|95.0|-25.0|3.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||3.0|-25.0|0.1095
71106860|NCT01819272|141720211|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-12.0||||0.0097|TWO_SIDED|95.0|-23.0|-3.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-3.0|-23.0|0.0097
71106861|NCT01819272|141720211|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-28.0|||<|0.0001|TWO_SIDED|95.0|-42.0|-17.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-17.0|-42.0|<0.0001
71054969|NCT00468650|141613283|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-13.13|STANDARD_DEVIATION|33.94|<|0.001||95.0|-19.76|-6.5||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||-6.50|-19.76|<0.001
71054970|NCT00468650|141613283|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-12.4|STANDARD_DEVIATION|33.13|<|0.001||95.0|-18.94|-5.86||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||-5.86|-18.94|<0.001
71054971|NCT00468650|141613284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.39|STANDARD_DEVIATION|22.0||0.2567||95.0|-6.55|1.77||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||1.77|-6.55|0.2567
71054972|NCT00468650|141613284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.91|STANDARD_DEVIATION|20.73||0.3435||95.0|-5.88|2.07||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||2.07|-5.88|0.3435
71054973|NCT00468650|141613284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.71|STANDARD_DEVIATION|22.28||0.2||95.0|-6.89|1.46||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||1.46|-6.89|0.2000
71054974|NCT00468650|141613284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.76|STANDARD_DEVIATION|22.48||0.2||95.0|-7.01|1.48||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||1.48|-7.01|0.2000
71054975|NCT00468650|141613285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-10.82|STANDARD_DEVIATION|56.75||0.0558||95.0|-21.91|0.27||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||0.27|-21.91|0.0558
71054976|NCT00468650|141613285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-29.16|STANDARD_DEVIATION|59.81|<|0.001||95.0|-40.96|-17.35||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||-17.35|-40.96|<0.001
71054977|NCT00468650|141613285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-30.79|STANDARD_DEVIATION|60.9|<|0.001||95.0|-43.0|-18.58||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||-18.58|-43.00|<0.001
71054978|NCT00468650|141613285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-30.27|STANDARD_DEVIATION|61.7|<|0.001||95.0|-42.33|-18.21||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||-18.21|-42.33|<0.001
71054979|NCT00468650|141613285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-30.87|STANDARD_DEVIATION|60.54|<|0.001||95.0|-42.82|-18.92||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||-18.92|-42.82|<0.001
71054980|NCT00468650|141613286|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|-18.36|STANDARD_DEVIATION|46.03|<|0.001||95.0|-27.05|-9.66||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||-9.66|-27.05|<0.001
71054981|NCT00468650|141613286|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-22.16|STANDARD_DEVIATION|45.24|<|0.001||95.0|-30.84|-13.49||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||-13.49|-30.84|<0.001
71054982|NCT00468650|141613286|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-20.28|STANDARD_DEVIATION|45.86|<|0.001||95.0|-28.87|-11.69||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||-11.69|-28.87|<0.001
71106862|NCT01819272|141720212|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-106.0||||0.0226|TWO_SIDED|95.0|-208.0|-16.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-16.00|-208.0|0.0226
71021848|NCT00106028|141551445|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.009||||0.9596|TWO_SIDED|95.0|-0.336|0.354|||ANOVA|LS means and p-value are from ANOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.354|-0.336|0.9596
71054983|NCT00468650|141613286|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-20.65|STANDARD_DEVIATION|46.2|<|0.001||95.0|-29.38|-11.92||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||-11.92|-29.38|<0.001
71106863|NCT01819272|141720212|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-106.0||||0.0068|TWO_SIDED|95.0|-180.0|-32.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-32.00|-180.0|0.0068
71021849|NCT00106028|141551446|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.107||||0.34||95.0|-0.114|0.328|||ANOVA|LS means and p-value are from ANOVA model with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.328|-0.114|0.3400
71021850|NCT00106028|141551447|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.029||||0.6218|TWO_SIDED|95.0|-0.084|0.142|||ANOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.142|-0.084|0.6218
71021851|NCT04428502|141551474|EQUIVALENCE|Hypothesis tested was to evaluate that there is no difference in response between ACCP positive and ACCP negative PsA participants who were treated with etanercept.||||||0.6|||||||Student's t-test|||At Month 1: P-value \<0.05 was considered statistically significant, without multiplicity adjustment.||||0.6
71021852|NCT04428502|141551474|EQUIVALENCE|Hypothesis tested was to evaluate that there is no difference in response between ACCP positive and ACCP negative PsA participants who were treated with etanercept.||||||0.007|||||||Student's t-test|||At Month 6: P-value \<0.05 was considered statistically significant, without multiplicity adjustment.||||0.007
71021853|NCT04428502|141551474|EQUIVALENCE|Hypothesis tested was to evaluate that there is no difference in response between ACCP positive and ACCP negative PsA participants who were treated with etanercept.||||||0.004|||||||Student's t-test|||At Month 12: P-value \<0.05 was considered statistically significant, without multiplicity adjustment.||||0.004
71021854|NCT03550794|141551477|OTHER||Mean Difference (Final Values)|-0.57||||0.07|TWO_SIDED|95.0|-1.18|0.04||"Mixed model controlling for repeated measures within patients used to get a mean difference in creatinine between the thiamine and placebo groups at 72 hours.~Missing creatinine imputed using a penalty (20pc increase) as described in SAP."|Mixed Models Analysis|P-value is for the comparison at 72 hours from the mixed model (i.e, not a global p-value)||||0.04|-1.18|0.07
71021855|NCT03550794|141551478|OTHER||Odds Ratio (OR)|0.58||||0.34|TWO_SIDED|95.0|0.18|1.74||P-value from odds ratio from logistic regression model controlling for site, with outcome of receiving renal replacement therapy.|Regression, Logistic|||||1.74|0.18|0.34
71021856|NCT03550794|141551479|OTHER||Median Difference (Final Values)|22.0||||0.002|TWO_SIDED|95.0|7.4|36.6||P-value from quantile regression model controlling for site.|Quantile regression|||||36.6|7.4|0.002
71021857|NCT03550794|141551480|OTHER||Hazard Ratio (HR)|0.62||||0.14|TWO_SIDED|95.0|0.32|1.18||P-value from Cox proportional hazards model adjusting for site.|Regression, Cox|||||1.18|0.32|0.14
71021858|NCT03550794|141551481|OTHER||Odds Ratio (OR)|0.43||||0.07|TWO_SIDED|95.0|0.17|1.06||P-value from logistic regression model controlling for site|Regression, Logistic|||||1.06|0.17|0.07
71021859|NCT03550794|141551482|OTHER||Mean Difference (Final Values)|0.96||||0.79|TWO_SIDED|95.0|0.71|1.3||"Mixed model controlling for repeated measures within patients used to get a mean difference in lactate between the thiamine and placebo groups at 72 hours.~Missing lactate imputed using a penalty (20pc increase) as described in SAP."|Mixed Models Analysis|P-value is for the comparison at 72 hours from the mixed model (i.e, not a global p-value)||||1.30|0.71|0.79
71021860|NCT03550794|141551484|OTHER||Mean Difference (Final Values)|-1.53||||0.16|TWO_SIDED|95.0|-3.63|0.58||"Mixed model controlling for repeated measures within patients used to get a mean difference in SOFA scores between the thiamine and placebo groups at 72 hours.~Missing SOFA imputed using a penalty (20pc increase) as described in SAP."|Mixed Models Analysis|P-value is for the comparison at 72 hours from the mixed model (i.e, not a global p-value)||||0.58|-3.63|0.16
71021861|NCT00449930|141551486|NON_INFERIORITY_OR_EQUIVALENCE|The pre-specified non-inferiority margin was 0.4%; i.e., non-inferiority required that the upper boundary of the 95% confidence interval for the treatment difference (sitagliptin minus metformin) to be less than 0.4%.|Mean Difference (Net)|0.14|STANDARD_DEVIATION|0.57||||95.0|0.06|0.21|||||Based on an analysis of covariance (ANCOVA) model with terms for treatment group and baseline value.|||0.21|0.06|
71021862|NCT00449930|141551487|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-7.3|||<|0.001||95.0|-10.6|-4.2|||Fisher Exact||"Difference (sitagliptin minus metformin) in the percentage of patients with diarrhea.~Wilson Score method was used for the 95% Confidence Interval (CI)."|||-4.2|-10.6|<0.001
71021863|NCT00449930|141551488|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.9||||0.032||95.0|-3.9|-0.2|||Fisher Exact||"Difference (sitagliptin minus metformin) in the percentage of patients with nausea.~Wilson Score method was used for the 95% CI."|||-0.2|-3.9|0.032
71054984|NCT00468650|141613287|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|33.27|STANDARD_DEVIATION|41.43|<|0.001||95.0|25.17|41.36||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||41.36|25.17|<0.001
71106864|NCT01819272|141720212|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-152.0||||0.0071|TWO_SIDED|95.0|-252.0|-42.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-42.00|-252.0|0.0071
70933002|NCT05886777|141366290|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A, RSV B as measured by NT:H0: ln(μ2)- ln(μ4) \<=ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 2, 4, respectively.|Geometric mean ratio|1.0|||||TWO_SIDED|97.5|0.769|1.288|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 2\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).|||1.288|0.769|
70933003|NCT05886777|141366291|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A, RSV B as measured by NT:H0: ln(μ2)- ln(μ4) \<=ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 2, 4, respectively.|Geometric mean ratio|1.09|||||TWO_SIDED|97.5|0.836|1.429|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 2\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).|||1.429|0.836|
70933004|NCT05886777|141366292|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 will be evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT:H0: ln(μ2)- ln(μ3) \<= ln(0.5)where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 2,3, respectively.|Geometric mean ratio|0.84|||||TWO_SIDED|97.5|0.594|1.19|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 2\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.190|0.594|
70933005|NCT05886777|141366293|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 will be evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT:H0: ln(μ2)- ln(μ3) \<= ln(0.5)where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 2,3, respectively.|Geometric mean ratio|0.84|||||TWO_SIDED|97.5|0.632|1.125|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 2\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.125|0.632|
70933006|NCT05886777|141366294|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A and B as measured by NT: H0: ln(μ1)- ln(μ4) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, ln(μ1), ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 7, 4, respectively.|Geometric mean ratio|1.42|||||TWO_SIDED|97.5|1.123|1.801|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).|||1.801|1.123|
70933007|NCT05886777|141366295|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A and B as measured by NT: H0: ln(μ1)- ln(μ4) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, ln(μ1), ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 7, 4, respectively.|Geometric mean ratio|1.27|||||TWO_SIDED|97.5|0.977|1.651|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).|||1.651|0.977|
70933008|NCT05886777|141366296|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 will be evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT:H0: ln(μ2)- ln(μ3) \<= ln(0.5)where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 7,3, respectively.|Geometric mean ratio|0.86|||||TWO_SIDED|97.5|0.61|1.208|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.208|0.610|
70933009|NCT05886777|141366297|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 was evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT: H0: ln(μ1)- ln(μ3) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 7, 3, respectively.|Geometric mean ratio|1.01|||||TWO_SIDED|97.5|0.764|1.34|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.340|0.764|
70933010|NCT05886777|141366298|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 7,5, respectively.|Geometric mean ratio|2.49|||||TWO_SIDED|97.5|1.914|3.232|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||3.232|1.914|
71106865|NCT01819272|141720212|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-101.0||||0.0405|TWO_SIDED|95.0|-208.0|-4.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-4.00|-208.0|0.0405
71106866|NCT01819272|141720212|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-224.0|||<|0.0001|TWO_SIDED|95.0|-334.0|-118.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-118.0|-334.0|<.0001
71106867|NCT01819272|141720213|SUPERIORITY_OR_OTHER||LS Mean|-0.48||||0.01|TWO_SIDED|95.0|-0.85|-0.12|||ANCOVA|Factor for treatment and baseline HbA1c as a covariate||||-0.12|-0.85|0.0100
71106868|NCT01819272|141720213|SUPERIORITY_OR_OTHER||LS Mean|-0.45||||0.0153|TWO_SIDED|95.0|-0.81|-0.09|||ANCOVA|Factor for treatment and baseline HbA1c as a covariate||||-0.09|-0.81|0.0153
70933011|NCT05886777|141366299|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 7,5, respectively.|Geometric mean ratio|1.3|||||TWO_SIDED|97.5|1.049|1.612|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||1.612|1.049|
70933012|NCT05886777|141366300|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 7,5, respectively.|Geometric mean ratio|1.58|||||TWO_SIDED|97.5|1.155|2.165|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||2.165|1.155|
70933013|NCT05886777|141366301|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 7,5, respectively.|Geometric mean ratio|3.49|||||TWO_SIDED|97.5|2.64|4.604|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||4.604|2.640|
70933014|NCT05886777|141366302|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A and B as measured by NT: H0: ln(μ1)- ln(μ4) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, ln(μ1), ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 6, 4, respectively.|Geometric mean ratio|1.43|||||TWO_SIDED|97.5|1.131|1.808|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 6\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).|||1.808|1.131|
70933015|NCT05886777|141366303|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A and B as measured by NT: H0: ln(μ1)- ln(μ4) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, ln(μ1), ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 6, 4, respectively.|Geometric mean ratio|1.37|||||TWO_SIDED|97.5|1.06|1.773|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 6\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).|||1.773|1.060|
70933016|NCT05886777|141366304|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 will be evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT:H0: ln(μ2)- ln(μ3) \<= ln(0.5)where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 6,3, respectively.|Geometric mean ratio|0.94|||||TWO_SIDED|97.5|0.673|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 6\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.300|0.673|
70941652|NCT04748445|141383934|OTHER||Slope|0.9159|STANDARD_ERROR_OF_MEAN|2.641||0.0007|TWO_SIDED|90.0|0.4783|1.354|||Mixed Models Analysis|||MM\_MFCC mean 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||1.354|0.4783|0.0007
71054985|NCT00468650|141613287|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|61.45|STANDARD_DEVIATION|44.77|<|0.001||95.0|52.61|70.29||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||70.29|52.61|<0.001
71054986|NCT00468650|141613287|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|66.1|STANDARD_DEVIATION|45.15|<|0.001||95.0|57.05|75.16||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||75.16|57.05|<0.001
71054987|NCT00468650|141613287|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|64.84|STANDARD_DEVIATION|45.7|<|0.001||95.0|55.91|73.77||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||73.77|55.91|<0.001
71054988|NCT00468650|141613287|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|65.13|STANDARD_DEVIATION|45.56|<|0.001||95.0|56.14|74.12||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||74.12|56.14|<0.001
71054989|NCT00468650|141613288|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|27.53|STANDARD_DEVIATION|40.19|<|0.001||95.0|19.94|35.13||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||35.13|19.94|<0.001
71054990|NCT00468650|141613288|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|30.92|STANDARD_DEVIATION|41.9|<|0.001||95.0|22.89|38.95||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||38.95|22.89|<0.001
71054991|NCT00468650|141613288|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|30.43|STANDARD_DEVIATION|41.88|<|0.001||95.0|22.59|38.27||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||38.27|22.59|<0.001
71054992|NCT00468650|141613288|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|30.98|STANDARD_DEVIATION|42.06|<|0.001||95.0|23.04|38.93||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||38.93|23.04|<0.001
71054993|NCT00468650|141613289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|22.45|STANDARD_DEVIATION|46.1|<|0.001||95.0|13.44|31.46||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||31.46|13.44|<0.001
71106869|NCT01819272|141720213|SUPERIORITY_OR_OTHER||LS Mean|-0.35||||0.0611|TWO_SIDED|95.0|-0.71|0.02|||ANCOVA|Factor for treatment and baseline HbA1c as a covariate||||0.02|-0.71|0.0611
71054994|NCT00468650|141613289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|32.3|STANDARD_DEVIATION|42.15|<|0.001||95.0|23.97|40.62||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||40.62|23.97|<0.001
71054995|NCT00468650|141613289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|35.31|STANDARD_DEVIATION|43.52|<|0.001||95.0|26.59|44.04||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||44.04|26.59|<0.001
71054996|NCT00468650|141613289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|34.57|STANDARD_DEVIATION|43.48|<|0.001||95.0|26.07|43.07||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||43.07|26.07|<0.001
71054997|NCT00468650|141613289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|34.26|STANDARD_DEVIATION|43.29|<|0.001||95.0|25.72|42.81||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||42.81|25.72|<0.001
71054998|NCT00468650|141613290|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.18|STANDARD_DEVIATION|29.45||0.0014||95.0|3.61|14.74||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||14.74|3.61|0.0014
71054999|NCT00468650|141613290|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|8.75|STANDARD_DEVIATION|29.26||0.0025||95.0|3.15|14.36||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||14.36|3.15|0.0025
71055000|NCT00468650|141613290|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.15|STANDARD_DEVIATION|31.11|<|0.001||95.0|4.32|15.97||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||15.97|4.32|<0.001
71106870|NCT01819272|141720213|SUPERIORITY_OR_OTHER||LS Mean|-0.45||||0.0188|TWO_SIDED|95.0|-0.83|-0.08|||ANCOVA|Factor for treatment and baseline HbA1c as acovariate||||-0.08|-0.83|0.0188
70933017|NCT05886777|141366305|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 will be evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT:H0: ln(μ2)- ln(μ3) \<= ln(0.5)where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 6,3, respectively.|Geometric mean ratio|0.97|||||TWO_SIDED|97.5|0.74|1.281|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 6\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.281|0.740|
71055001|NCT00468650|141613290|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.33|STANDARD_DEVIATION|31.36|<|0.001||95.0|4.41|16.26||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||16.26|4.41|<0.001
71106871|NCT01819272|141720213|SUPERIORITY_OR_OTHER||LS Mean|-0.67||||0.0006|TWO_SIDED|95.0|-1.04|-0.29|||ANCOVA|Factor for treatment and baseline HbA1c as a covariate||||-0.29|-1.04|0.0006
71106872|NCT01246960|141720234|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.886|TWO_SIDED|95.0|0.69|1.37|||Stratified Log Rank|||||1.37|0.69|0.886
71055002|NCT03201965|141613317|SUPERIORITY||Odds Ratio (OR)|5.13|||<|0.0001|TWO_SIDED|95.0|3.22|8.16|||Cochran-Mantel-Haenszel|||||8.16|3.22|<0.0001
71055003|NCT03322930|141613329|OTHER||||||<|0.05||||||calculated from data|t-test, 2 sided||||mean sensitivity for group; Coefficient of Repeatability for multiple tests per patient|||<0.05
71055004|NCT01687244|141613330|SUPERIORITY_OR_OTHER||HGRF survival at 12 months|33.3|||||TWO_SIDED|90.0|16.8|53.6||Not applicable: the primary analysis was a calculation of a confidence interval||||The primary efficacy endpoint was the incidence of high-grade recurrence-free survival at 12 months. The proportion of patients achieving high-grade recurrence-free survival at 12 months was reported for each dose group, together with an exact 90% confidence interval for the proportion||53.6|16.8|
71055005|NCT01687244|141613330|SUPERIORITY_OR_OTHER||HGRF survival at 12 months|36.8|||||TWO_SIDED|90.0|18.8|58.2|||||The proportion of subjects achieving high-grade recurrence-free survival at 12 months|The primary efficacy endpoint was the incidence of high-grade recurrence-free survival at 12 months. The proportion of patients achieving high-grade recurrence-free survival at 12 months was reported for each dose group, together with an exact 90% confidence interval for the proportion.||58.2|18.8|
71055006|NCT02373189|141613343|SUPERIORITY|||||||0.05||||||The P-value indicated above is calculated.|paired t-test|means at pre and post treatment were compared within subject.||||||0.05
71055007|NCT02373189|141613344|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
71106873|NCT01246960|141720235|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.712|TWO_SIDED|95.0|0.73|1.58|||Stratified Log Rank|||||1.58|0.73|0.712
71106874|NCT01246960|141720238|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.516|TWO_SIDED|95.0|0.59|1.3|||Stratified Log Rank|||||1.30|0.59|0.516
71106875|NCT03376516|141720283|OTHER|||||||0.9593||||||P-Value for patients aged 1-\<6 years (N=5)|ANOVA|||||||0.9593
71106876|NCT03376516|141720283|OTHER|||||||0.3752||||||P-Value for patients aged 6-\<12 years (N=5)|ANOVA|||||||0.3752
71106877|NCT03376516|141720283|OTHER|||||||0.8273||||||P-Value for total PK population (N=10)|ANOVA|||||||0.8273
71106878|NCT03376516|141720284|OTHER|P-Value for patients aged 1-\<6 years (N=5)||||||0.8536|||||||ANOVA|||||||0.8536
71106879|NCT03376516|141720284|OTHER|||||||0.9791||||||P-Value for patients aged 6-\<12 years (N=5)|ANOVA|||||||0.9791
70933018|NCT02232737|141366337|SUPERIORITY||Mean Difference (Net)|-5.33|STANDARD_ERROR_OF_MEAN|1.06|<|0.0001|TWO_SIDED|95.0|-7.41|-3.26||The p-value is Bonferroni-corrected for multiple comparisons with a priori threshold of significance P \< 0.0167|ANCOVA||Group difference = 0.12 mg nicotine - 0.8 mg nicotine|The statistical analysis method was ANCOVA, in order to test for statistically significant differences between group means, while controlling for covariates of interest. It was calculated that 207 subjects per group would be required to have at least 90% power to detect a mean difference of 4.52 CPD between the 0.8 mg and 0.12 mg groups at week 12, with significance level alpha of 0.0167. The significance level reflects the Bonferroni correction needed for testing of all pairwise comparisons.||-3.26|-7.41|<0.0001
70933019|NCT02232737|141366337|SUPERIORITY||Mean Difference (Net)|-7.54|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|-9.51|-5.57||The p-value is Bonferroni-corrected for multiple comparisons with a priori threshold of significance P \< 0.0167|ANCOVA||Group difference = 0.03 mg nicotine - 0.8 mg nicotine|The statistical analysis method was ANCOVA, in order to test for statistically significant differences between group means, while controlling for covariates of interest. It was calculated that 207 subjects per group would be required to have at least 90% power to detect a mean difference of 4.52 CPD between the 0.8 mg and 0.12 mg groups at week 12, with significance level alpha of 0.0167. The significance level reflects the Bonferroni correction needed for testing of all pairwise comparisons.||-5.57|-9.51|<0.0001
70933020|NCT01478594|141366434|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.091||||0.706|TWO_SIDED|95.0|0.693|1.718|||Log Rank|Stratification factors were LDH status (\< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).|HR presented for the stratified analysis, which was based on the Cox proportional hazards model. Assuming proportional hazards, an HR \< 1 indicates a reduction in the HR in favor of tivozanib.|An interim futility analysis was to be performed when approximately 83 PFS events (50% of the total PFS events) were observed. The Lans DeMets beta spending function with an O'Brien-Fleming boundary was used to derive the futility boundary. If the hazard ratio (HR) for PFS was greater than 1.0581, enrollment was to be stopped. With this futility stopping rule, the adjusted study power was 78.6%.||1.718|0.693|0.706
70933021|NCT01478594|141366436|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.116||||0.754|TWO_SIDED|95.0|0.561|2.218|||Log Rank|Stratification factors were LDH status (\< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).|HR presented for the stratified analysis, which was based on the Cox proportional hazards model. Assuming proportional hazards, an HR \< 1 indicates a reduction in the HR in favor of tivozanib.|||2.218|0.561|0.754
70933022|NCT01478594|141366437|SUPERIORITY_OR_OTHER|||||||0.718|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratification factors were LDH status (\< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).||||||0.718
70933023|NCT01478594|141366438|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.389||||0.437|TWO_SIDED|95.0|0.604|3.194|||Log Rank|Stratification factors were LDH status (\< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).|HR presented for the stratified analysis, which was based on the Cox proportional hazards model. Assuming proportional hazards, an HR \< 1 indicates a reduction in the HR in favor of tivozanib.|||3.194|0.604|0.437
70933024|NCT01478594|141366439|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.006||||0.967|TWO_SIDED|95.0|0.746|1.358|||Log Rank|Stratification factors were LDH status (\< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).|HR presented for the stratified analysis, which was based on the Cox proportional hazards model. Assuming proportional hazards, an HR \< 1 indicates a reduction in the HR in favor of tivozanib.|||1.358|0.746|0.967
70933025|NCT01478594|141366442|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.331|||||TWO_SIDED|95.0|0.746|2.375|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.375|0.746|
71055008|NCT03344861|141613345|OTHER|No comparator arm.|Clopper-Pearson (binomial proportion)|0.05|||<|0.05|TWO_SIDED||||||exact Clopper-Pearson binomial method|One-sided 95% upper confidence limit for the event percentage was calculated using exact (Clopper-Pearson) method for binomial proportion.|One-sided 95% upper confidence limit for the event percentage was calculated using exact (Clopper-Pearson) method for binomial proportion|Adverse events will be listed, coded by MedDRA, by system organ class and preferred term.||||<0.05
71055009|NCT03344861|141613370|OTHER||||||<|0.05|||||||exact Clopper-Pearson binomial method|One-sided 95% upper confidence limit for the event percentage, calculated using exact (Clopper-Pearson) method for binomial proportion.||"All adverse event terms are coded using MedDRA Dictionary version 21.1. NCS (Non-Clinical Significant) events were not included in the summary because their CTCAE grade and relationship were not collected. Subjects are counted once within each system organ class and each preferred term. An AE is defined as treatment related if its relationship to the study drug is recorded as reasonable possibility on the CRF (Case Report Form)."||||<0.05
71055010|NCT02151877|141613371|OTHER||||||>|0.05||||||This test applies to the first marker, cardiac troponin I.|t-test, 2 sided|||Null: mean cardiac troponin I changes in the NO group = mean cardiac troponin I changes in the control||||>0.05
71055011|NCT02151877|141613372|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Null: NO group fluid balances are the same as the control||||>0.05
71055012|NCT00758680|141613378|SUPERIORITY_OR_OTHER||LS Mean Difference on Last Dosing Day|37.63||||0.015|TWO_SIDED|95.0|12.58|62.68|||Mixed Effect Model|||||62.68|12.58|0.015
71055013|NCT00758680|141613378|SUPERIORITY_OR_OTHER||LS Mean Difference on Last Dosing Day|92.3|||<|0.001|TWO_SIDED|95.0|67.56|117.04|||Mixed Effect Model|||||117.04|67.56|<0.001
71055014|NCT00574912|141613382|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71055015|NCT01282723|141613383|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.0093|TWO_SIDED|95.0|1.1|1.95|||Mixed Models Analysis|||"Estimation of Odds Ratio of True Positive Fraction between SureCALL® and TOCO~Null hypothesis: There is no difference between the True Positive Fraction of SureCALL® and of TOCO or the SureCALL® is significantly greater than TOCO.~Alternative hypothesis: There is a difference between the True Positive Fraction of SureCALL® and of TOCO and the TOCO is significantly greater than SureCALL®."||1.95|1.10|0.0093
71106880|NCT03376516|141720284|OTHER|||||||0.9791||||||P-Value for total PK population (N=10)|ANOVA|||||||0.9791
71106881|NCT03376516|141720286|OTHER||Pearson-Copper|0.0|||||TWO_SIDED|95.0|0.0|30.85||||||||30.85|0|
71106882|NCT00370292|141720308|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 1 Hour Post-Dose (1 hour across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
71106883|NCT00370292|141720308|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 2 Hours Post-Dose (2 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
70933026|NCT01478594|141366442|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.575|||||TWO_SIDED|95.0|0.285|1.16|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.160|0.285|
70933027|NCT01478594|141366443|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.608|||||TWO_SIDED|95.0|0.635|4.073|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||4.073|0.635|
71106884|NCT00370292|141720308|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-value for 4 Hours Post-Dose (4 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||0.030
71106885|NCT00370292|141720308|SUPERIORITY_OR_OTHER|||||||0.166||95.0||||P-value for 6 Hours Post-Dose (6 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||0.166
71106886|NCT00370292|141720308|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 24 Hours Post-Dose (24 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
71106887|NCT00370292|141720308|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 48 Hours Post-Dose (48 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
71106888|NCT00370292|141720310|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 1 Hour Post-Dose (1 hour across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
71106889|NCT00370292|141720310|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 2 Hours Post-Dose (2 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
71106890|NCT00370292|141720310|SUPERIORITY_OR_OTHER|||||||0.333||95.0||||P-value for 4 Hours Post-Dose (4 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||0.333
71106891|NCT00370292|141720310|SUPERIORITY_OR_OTHER|||||||0.849||95.0||||P-value for 6 Hours Post-Dose (6 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||0.849
71106892|NCT00370292|141720310|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 24 Hours Post-Dose (24 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
71106893|NCT00370292|141720310|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 48 Hours Post-Dose (48 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
70933028|NCT01478594|141366443|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.755|||||TWO_SIDED|95.0|0.375|1.521|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.521|0.375|
71106894|NCT00508521|141720314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.75|STANDARD_ERROR_OF_MEAN|0.47871||0.0001|TWO_SIDED|95.0|-22.27348|-19.22652|||t-test, 2 sided|||This was a feasibility study. Pre and post treatment analysis was performed for the study participants.||-19.22652|-22.27348|.0001
71106895|NCT01622296|141720315|SUPERIORITY_OR_OTHER|||||||0.23||||||Significant at p\<0.05|t-test, 2 sided|||Inferior Alveolar nerve injection - H(0): Lidocaine VAS score = Buffered Lidocaine VAS score. Based on data from medial trials of buffered anesthetic, a power calculation for sample size indicated that 20 subjects would provide a 90% change of detecting an effect size of 0.83 (a change of 0.83 standard deviations)||||0.23
71106896|NCT01622296|141720315|SUPERIORITY_OR_OTHER|||||||0.57||||||Significant at p\<0.05|t-test, 2 sided|||Long buccal nerve injection - H(0): Lidocaine VAS score = Buffered Lidocaine VAS score. Based on data from medial trials of buffered anesthetic, a power calculation for sample size indicated that 20 subjects would provide a 90% change of detecting an effect size of 0.83 (a change of 0.83 standard deviations)||||0.57
71106897|NCT00372957|141720326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1|||||TWO_SIDED|95.0|-2.28|-1.93|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7||-1.93|-2.28|
71106898|NCT00372957|141720326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.16|||||TWO_SIDED|95.0|-2.33|-1.98|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7||-1.98|-2.33|
71106899|NCT00372957|141720326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98|||||TWO_SIDED|95.0|-2.15|-1.82|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7||-1.82|-2.15|
71106900|NCT00372957|141720326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.12|||||TWO_SIDED|95.0|-2.28|-1.95|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7||-1.95|-2.28|
71106901|NCT00372957|141720327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.87|||||TWO_SIDED|95.0|2.33|5.41|||Double-delta analysis||he point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7||5.41|2.33|
71106902|NCT00372957|141720327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.21|||||TWO_SIDED|95.0|3.7|6.73|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7||6.73|3.70|
71021864|NCT00449930|141551489|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.7||||0.103||95.0|-4.0|0.3|||Fisher Exact||"Difference (sitagliptin minus metformin) in the percentage of patients with abdominal pain.~Wilson Score method was used for the 95% CI."|||0.3|-4.0|0.103
71106903|NCT00372957|141720327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.22|||||TWO_SIDED|95.0|1.9|4.54|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7||4.54|1.90|
71106904|NCT00372957|141720327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.39|||||TWO_SIDED|95.0|3.1|5.68|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7||5.68|3.10|
70933029|NCT01478594|141366444|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.877|||||TWO_SIDED|95.0|0.366|2.1|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.100|0.366|
71106905|NCT00372957|141720328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.56|||||TWO_SIDED|95.0|-6.0|2.89|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7||2.89|-6.00|
71106906|NCT00372957|141720328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21|||||TWO_SIDED|95.0|-3.3|5.72|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7||5.72|-3.30|
71106907|NCT00372957|141720328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35|||||TWO_SIDED|95.0|-5.2|2.5|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7||2.50|-5.20|
71106908|NCT00372957|141720328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.48|||||TWO_SIDED|95.0|-2.47|5.43|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7||5.43|-2.47|
71106909|NCT00372957|141720329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1|||||TWO_SIDED|95.0|-20.4|4.2|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7||4.2|-20.4|
71106910|NCT00372957|141720329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2|||||TWO_SIDED|95.0|-28.4|-3.9|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7||-3.9|-28.4|
71106911|NCT00372957|141720329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9|||||TWO_SIDED|95.0|-23.1|1.4|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7||1.4|-23.1|
71106912|NCT00372957|141720329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.6|||||TWO_SIDED|95.0|-27.9|-3.3|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7||-3.3|-27.9|
71106913|NCT00372957|141720330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|||||TWO_SIDED|95.0|-0.64|1.16|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7||1.16|-0.64|
70933030|NCT01478594|141366444|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.275|||||TWO_SIDED|95.0|0.614|2.646|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.646|0.614|
70933031|NCT01478594|141366445|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.721|||||TWO_SIDED|95.0|0.345|1.507|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.507|0.345|
71021865|NCT00449930|141551490|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.0||||||95.0|-2.4|0.2|||||"Difference (sitagliptin minus metformin) in the percentage of patients with vomiting.~Wilson Score method was used for the 95% CI."|||0.2|-2.4|
71106914|NCT00372957|141720330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43|||||TWO_SIDED|95.0|-0.47|1.32|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7||1.32|-0.47|
71106915|NCT00372957|141720330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|||||TWO_SIDED|95.0|-0.37|1.07|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7||1.07|-0.37|
71106916|NCT00372957|141720330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48|||||TWO_SIDED|95.0|-0.24|1.21|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7||1.21|-0.24|
71106917|NCT00372957|141720331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.9|||||TWO_SIDED|95.0|-40.7|0.9|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7||0.9|-40.7|
71106918|NCT00372957|141720331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|||||TWO_SIDED|95.0|-29.8|11.7|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7||11.7|-29.8|
71106919|NCT00372957|141720331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.9|||||TWO_SIDED|95.0|-33.2|1.4|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7||1.4|-33.2|
71106920|NCT00372957|141720331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.2|||||TWO_SIDED|95.0|-23.4|11.1|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7||11.1|-23.4|
71106921|NCT04778592|141720333|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.291||0.4549|TWO_SIDED|95.0|-0.36|0.79|||Mixed Models Analysis|||||0.79|-0.36|0.4549
71106922|NCT02431325|141720365|SUPERIORITY|||||||0.01|||||||ANCOVA|||||||0.01
71106923|NCT02431325|141720366|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
71106924|NCT02431325|141720367|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||||||0.87
71106925|NCT02431325|141720368|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||0.047
71106926|NCT02431325|141720369|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70933032|NCT01478594|141366445|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.597|||||TWO_SIDED|95.0|0.672|3.795|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||3.795|0.672|
70933033|NCT01478594|141366446|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.627|||||TWO_SIDED|95.0|0.58|4.564|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||4.564|0.580|
70933034|NCT01478594|141366446|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.779|||||TWO_SIDED|95.0|0.397|1.531|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.531|0.397|
71021866|NCT01864525|141551491|SUPERIORITY|||||||0.0216||||||Statistical results for Magnitude of acoustic amplitude tremor. A priori significance threshold was set at P\<0.05 for each of the two hypothesis-driven acoustic variables.|Mixed Models Analysis|This statistical test did not use the baseline scores as a covariate when comparing post-test scores between placebo and octanoic acid conditions.||Separate measures for magnitude of amplitude tremor and magnitude of frequency tremor were analyzed as these variables can respond differently to treatment and may be differentially affected in essential voice tremor. Statistical modeling tested for post-treatment drug differences, with testing session as a repeated factor. Models were run with and without inclusion of baseline averages as a covariate per recommendations for cross-over treatment studies (Fleiss, Wallenstein \& Rosenfeld, 1985).||||0.0216
71021867|NCT01864525|141551491|SUPERIORITY|||||||0.0499||||||Statistical results for Magnitude of acoustic amplitude tremor. A priori significance threshold was set at P\<0.05 for each of the two hypothesis-driven acoustic variables.|Mixed Models Analysis|This statistical test used the baseline scores as a covariate when comparing post-test scores between placebo and octanoic acid conditions.||Separate measures for magnitude of amplitude tremor and magnitude of frequency tremor were analyzed as these variables can respond differently to treatment and may be differentially affected in essential voice tremor. Statistical modeling tested for post-treatment drug differences, with testing session as a repeated factor. Models were run with and without inclusion of baseline averages as a covariate per recommendations for cross-over treatment studies (Fleiss, Wallenstein \& Rosenfeld, 1985).||||0.0499
71055016|NCT01282723|141613383|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.3204|TWO_SIDED|95.0|0.61|1.17|||Mixed Models Analysis|||"Estimation of Odds Ratio of False Positive Fraction between SureCALL® and TOCO~Null hypothesis: There is no difference between the False Positive Fraction of SureCALL® and of TOCO or the SureCALL® is significantly less than TOCO.~Alternative hypothesis: There is a difference between the False Positive Fraction of SureCALL® and of TOCO and the TOCO is significantly less than SureCALL®."||1.17|0.61|0.3204
71055017|NCT03400943|141613520|SUPERIORITY||Risk Difference (RD)|0.56|||<|0.0001|TWO_SIDED|95.0|0.33|0.78|||Cochran-Mantel-Haenszel||Number of subjects per treatment: 41 (Vilaprisan) / 20 (Placebo).|Vilaprisan (A1) and Vilaprisan+Placebo (B2) combined vs. Placebo+Vilaprisan (B1) in treatment period 1||0.78|0.33|<.0001
71055018|NCT02563106|141613527|OTHER|The analysis of the primary endpoint was based on the mITT analysis set. Per-protocol and worse case analyses were performed as sensitivity analyses.The P-value was based on a one-sided z-test for the comparison of the treatment difference between the SYN-004 group and the Placebo group.|Relative Risk Reduction (%)|71.4||||0.045|TWO_SIDED|95.0|-35.9|94.0||Study was designed to provide 80% power to detect treatment effect with one-sided alpha = 0.05 on the primary endpoint. Based on the pre-specified z-test the one-sided P=0.045.|z-test|1-sided P=0.045.|Relative Risk Reduction in SYN-004 group compared to Placebo group.|The Modified Intent-to-Treat (mITT) analysis set included randomized subjects who received at least 1 dose of study drug. Number of subjects with CDI, imputing early termination without CDI as not being treatment failures.||94.0|-35.9|0.045
71055019|NCT02784444|141613549|SUPERIORITY||Odds Ratio (OR)|0.89||||0.747|TWO_SIDED|95.0|0.44|1.81||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||1.81|0.44|0.747
71055020|NCT02784444|141613549|SUPERIORITY||Odds Ratio (OR)|1.22||||0.575|TWO_SIDED|95.0|0.6|2.48||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||2.48|0.60|0.575
71055021|NCT02784444|141613549|SUPERIORITY||Odds Ratio (OR)|1.64||||0.158|TWO_SIDED|95.0|0.83|3.27||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||3.27|0.83|0.158
71106927|NCT02431325|141720370|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
71106928|NCT02431325|141720371|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||0.68
71106929|NCT02431325|141720372|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||||||0.49
71106930|NCT02431325|141720373|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
71106931|NCT02431325|141720374|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
71106932|NCT02431325|141720375|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
71106933|NCT02431325|141720376|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
71106934|NCT02431325|141720377|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||||||0.34
71106935|NCT02431325|141720378|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||||||0.33
71106936|NCT02431325|141720379|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
71106937|NCT02431325|141720380|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.51
71106938|NCT02431325|141720381|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||||||0.93
71106939|NCT02431325|141720382|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Change from baseline at week 24||||0.09
70933035|NCT01478594|141366447|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.946|||||TWO_SIDED|95.0|0.636|5.956|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||5.956|0.636|
70933036|NCT01478594|141366447|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.806|||||TWO_SIDED|95.0|0.422|1.538|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.538|0.422|
70933037|NCT01478594|141366448|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.776|||||TWO_SIDED|95.0|0.303|1.991|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.991|0.303|
70933038|NCT01478594|141366448|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.241|||||TWO_SIDED|95.0|0.615|2.501|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.501|0.615|
70933039|NCT01478594|141366449|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.343|2.63|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.630|0.343|
70933040|NCT01478594|141366449|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.983|||||TWO_SIDED|95.0|0.503|1.918|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.918|0.503|
70933041|NCT01478594|141366450|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.226|||||TWO_SIDED|95.0|0.468|3.214|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||3.214|0.468|
70933042|NCT01478594|141366450|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.232|||||TWO_SIDED|95.0|0.447|3.396|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||3.396|0.447|
70933043|NCT01478594|141366451|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.803|||||TWO_SIDED|95.0|0.307|2.1|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.100|0.307|
70933044|NCT01478594|141366451|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.505|||||TWO_SIDED|95.0|0.585|3.873|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||3.873|0.585|
70933045|NCT01478594|141366452|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.921|||||TWO_SIDED|95.0|0.356|2.385|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.385|0.356|
70933046|NCT01478594|141366452|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22|||||TWO_SIDED|95.0|0.462|3.22|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||3.220|0.462|
70933047|NCT01478594|141366453|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.915|||||TWO_SIDED|95.0|0.334|2.512|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.512|0.334|
71055022|NCT02784444|141613550|SUPERIORITY||Odds Ratio (OR)|1.09||||0.828|TWO_SIDED|95.0|0.49|2.42||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||2.42|0.49|0.828
70933048|NCT01478594|141366453|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.384|||||TWO_SIDED|95.0|0.554|3.455|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||3.455|0.554|
70933049|NCT01478594|141366454|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.538|||||TWO_SIDED|95.0|0.548|4.32|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||4.320|0.548|
70933050|NCT01478594|141366454|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.744|||||TWO_SIDED|95.0|0.299|1.85|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.850|0.299|
70933051|NCT02927249|141366455|SUPERIORITY||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.91|1.56||||||||1.56|0.91|
70933052|NCT02927249|141366456|SUPERIORITY||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.74|1.69||||||||1.69|0.74|
71106940|NCT02431325|141720382|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Change from baseline at week 12||||0.25
71106941|NCT02431325|141720383|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.51
71106942|NCT02431325|141720384|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
71106943|NCT00744861|141720385|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9905|||||||Cochran-Mantel-Haenszel|site stratified||||||0.9905
71106944|NCT02347605|141720397|SUPERIORITY|||||||0.25||||||Adjusted for treatment order, session, room sequence|Mixed Models Analysis|||||||0.25
71106945|NCT02347605|141720398|SUPERIORITY|||||||0.18||||||Adjusted for treatment order, session, room sequence|Mixed Models Analysis|||||||0.18
71021868|NCT01864525|141551491|SUPERIORITY|||||||0.0339||||||Statistical results for Magnitude of acoustic frequency tremor. A priori significance threshold was set at P\<0.05 for each of the two hypothesis-driven acoustic variables.|Mixed Models Analysis|This statistical test did not use the baseline scores as a covariate when comparing post-test scores between placebo and octanoic acid conditions.||Separate measures for magnitude of amplitude tremor and magnitude of frequency tremor were analyzed as these variables can respond differently to treatment and may be differentially affected in essential voice tremor. Statistical modeling tested for post-treatment drug differences, with testing session as a repeated factor. Models were run with and without inclusion of baseline averages as a covariate per recommendations for cross-over treatment studies (Fleiss, Wallenstein \& Rosenfeld, 1985).||||0.0339
71021869|NCT01864525|141551491|SUPERIORITY|||||||0.045||||||Statistical results for Magnitude of acoustic frequency tremor. A priori significance threshold was set at P\<0.05 for each of the two hypothesis-driven acoustic variables.|Mixed Models Analysis|This statistical test used the baseline scores as a covariate when comparing post-test scores between placebo and octanoic acid conditions.||Separate measures for magnitude of amplitude tremor and magnitude of frequency tremor were analyzed as these variables can respond differently to treatment and may be differentially affected in essential voice tremor. Statistical modeling tested for post-treatment drug differences, with testing session as a repeated factor. Models were run with and without inclusion of baseline averages as a covariate per recommendations for cross-over treatment studies (Fleiss, Wallenstein \& Rosenfeld, 1985).||||0.0450
70933053|NCT02927249|141366457|SUPERIORITY||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.83|1.52||||||||1.52|0.83|
70933054|NCT01536093|141366495|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||||||0.006
70933055|NCT01536093|141366496|SUPERIORITY_OR_OTHER|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||||||0.043
70933056|NCT01536093|141366497|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
70933057|NCT01536093|141366498|SUPERIORITY_OR_OTHER|||||||0.038|||||||Wilcoxon (Mann-Whitney)|||||||0.038
70933058|NCT01536093|141366499|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.010
71055023|NCT02784444|141613550|SUPERIORITY||Odds Ratio (OR)|1.5||||0.299|TWO_SIDED|95.0|0.7|3.21||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||3.21|0.70|0.299
71055024|NCT02784444|141613550|SUPERIORITY||Odds Ratio (OR)|1.82||||0.116|TWO_SIDED|95.0|0.86|3.82||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||3.82|0.86|0.116
71055025|NCT02784444|141613551|SUPERIORITY||Odds Ratio (OR)|1.19||||0.657|TWO_SIDED|95.0|0.55|2.55||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||2.55|0.55|0.657
71055026|NCT02784444|141613551|SUPERIORITY||Odds Ratio (OR)|1.45||||0.332|TWO_SIDED|95.0|0.69|3.06||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||3.06|0.69|0.332
71055027|NCT02784444|141613551|SUPERIORITY||Odds Ratio (OR)|1.51||||0.27|TWO_SIDED|95.0|0.72|3.16||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||3.16|0.72|0.270
70933059|NCT01536093|141366500|SUPERIORITY_OR_OTHER|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
70933060|NCT01759862|141366520|SUPERIORITY|Our calculations showed that by enrolling 50 patients we will be able to detect a 25cc/min absolute difference in eGFR between the two arms with power above 80%, and a two-sided Type I probability error of \<0.05.||||||0.32|||||||t-test, 2 sided|||Intention to treat analysis||||0.32
70933061|NCT01759862|141366521|SUPERIORITY|Enrolling 25 patients in each group will allow us to detect a difference of 200ng/mg cr in urinary NGAL levels between the two groups with a power of 80% and a two-sided type I probability error of 0.05.||||||0.95|||||||Kruskal-Wallis|||||||0.95
70933062|NCT01759862|141366522|SUPERIORITY|||||||0.67|||||||Chi-squared|||||||0.67
70933063|NCT00731614|141366523|SUPERIORITY_OR_OTHER_LEGACY|||||||0.322|||||||Repeated Measure ANOVA|||Conducted a repeated measures ANOVA comparing CBT+mirror retraining with Supportive Therapy across 11 time points. The primary hypothesis was a group by time interaction. Due to missing data, a total of 9 and 14 participants, respectively could be included in analyses.||||.322
70933064|NCT03387189|141366534|SUPERIORITY|Alpha - 0.05|Odds Ratio (OR)|0.39||||0.031|TWO_SIDED|95.0|0.17|0.91|||Regression, Logistic|Adjusted for length of second stage cesarean section, fetal station, delivery method, use of instrumentation , parity, and gestational age|Y = Intervention + Time + Intervention\*Time + Covariates. Provided estimation parameter is the OR from the interaction term and can be interpreted as the differential change in odds of outcome from pre to post period associated with the intervention.|||0.91|0.17|0.031
70933065|NCT03387189|141366535|SUPERIORITY|Alpha - 0.05|Odds Ratio (OR)|1.46||||0.465|TWO_SIDED|95.0|0.53|4.03|||Regression, Logistic|Adjusted for length of second stage cesarean section, fetal station, delivery method, use of instrumentation , parity, and gestational age|Y = Intervention + Time + Intervention\*Time + Covariates. Provided estimation parameter is the OR from the interaction term and can be interpreted as the differential change in odds of outcome from pre to post period associated with the intervention.|||4.03|0.53|0.465
70933066|NCT03387189|141366536|SUPERIORITY|alpha - 0.05|Mean Difference (Final Values)|-11.4||||0.01|TWO_SIDED|95.0|-20.4|-2.5|||t-test, 2 sided|||||-2.5|-20.4|0.01
70933067|NCT03387189|141366537|SUPERIORITY|Alpha - 0.05|Mean Difference (Final Values)|-1.0||||0.75|TWO_SIDED|95.0|-76.0|5.5|||t-test, 2 sided|||||5.5|-76.0|0.75
71021870|NCT01864525|141551492|SUPERIORITY|||||||0.7172||||||A priori significance was set at P\<0.05 for this hypothesis-driven auditory-perceptual variable. Main effect for drug is given above. For the main task effect, P=0.9602. For the interaction effect of drug\*task, P=0.1699.|Mixed Models Analysis|||Statistical modeling tested for main effects of auditory-perceptual ratings for drug and task (sustained vowel and sentence-level ratings), and interaction effects of these variables. The summed scores, averaged across all participants, are provided separately for the sustained vowel and sentence-level ratings. Values range from 0 (no difference between baseline and post-test) to 3 (all three raters indicated that post-test sample was better (less tremor severity).||||0.7172
71021871|NCT02295280|141551510|SUPERIORITY|||||||0.14||||||Reduction in pain scores by at least 2 units six hours post administration|Mann Whitney U test|Mann Whitney U test used for analysis of this continuous variable as data were not normally distributed. Outcome was comparable at the 6-hour mark.||A sample size calculation of 35 patients in each group was based on an estimated reduction in headache pain score by at least two points, with an a of 0.05 and power of 90%, which is similar to estimates reported in prior studies in non-pregnant patients and felt to be a clinically significant decrease. Statistical analyses were performed using chi-square, Fisher's exact test for categorical variables, the independent Student's t-test and Kolmogorov-Smirnov for continuous variables.||||0.14
71021872|NCT03001011|141551511|SUPERIORITY||Median difference (Renvela - Placebo)|-0.21|||<|0.0001|TWO_SIDED|||||Threshold for statistical significance at 0.05.|Wilcoxon rank sum test||Renvela Vs. Placebo|A hierarchical testing procedure was used to control type I error \& handle multiple secondary endpoint analyses. Testing was then performed sequentially in order outcome measures (OM) are reported. The hierarchical testing sequence continued only when previous OM was statistically significant at 0.05 level.||||<0.0001
71021873|NCT00065065|141551535|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0||||0.005||95.0|1.5|10.5|||Regression, Logistic|||||10.5|1.5|.005
71021874|NCT01241565|141551538|SUPERIORITY_OR_OTHER||Rate of incidence of PAL|10.6|||||TWO_SIDED|95.0|3.9|21.3|||||Incidence of Prolonged Air Leak (PAL) is estimated at between 5-10% in literature. PAL of 10%of evaluable cases was used to determine study success.|||21.3|3.9|
71021875|NCT04128696|141551592|SUPERIORITY||Hazard Ratio (HR)|1.51||||0.973|TWO_SIDED|95.0|0.99|2.29||Nominal p-value was calculated based on the one-sided log-rank test, stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||2.29|0.99|0.973
71021876|NCT04128696|141551593|SUPERIORITY||Hazard Ratio (HR)|4.44|||>|0.999|TWO_SIDED|95.0|2.01|9.82||Nominal p-value was calculated based on the one-sided log-rank test, stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||9.82|2.01|>0.999
71021877|NCT04128696|141551594|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.989|TWO_SIDED|95.0|1.05|1.86||Nominal p-value was calculated based on the log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||1.86|1.05|0.989
71021878|NCT04128696|141551595|SUPERIORITY||Hazard Ratio (HR)|1.48||||0.996|TWO_SIDED|95.0|1.1|1.99||Nominal p-value was calculated based on the log-rank test, stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the cox regression model with Efron's method of tie handling, a treatment covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx)||1.99|1.10|0.996
71021879|NCT04128696|141551596|SUPERIORITY||Hazard Ratio (HR)|1.55|||||TWO_SIDED|95.0|0.98|2.43|||Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx)||2.43|0.98|
71021880|NCT04128696|141551597|SUPERIORITY||Hazard Ratio (HR)|1.59|||||TWO_SIDED|95.0|1.0|2.53|||Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||2.53|1.00|
71021881|NCT04128696|141551602|OTHER||Difference in Percentage|-5.3|||||TWO_SIDED|95.0|-14.6|4.0||||||The comparison between the treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||4.0|-14.6|
71021882|NCT04128696|141551603|OTHER||Difference in Percentage|-13.3|||||TWO_SIDED|95.0|-27.8|1.5||||||The comparison between the treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||1.5|-27.8|
71055028|NCT02784444|141613552|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.392|TWO_SIDED|95.0|-0.7|0.3||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.3|-0.7|0.392
70933068|NCT03387189|141366538|SUPERIORITY|Alpha - 0.05|Mean Difference (Final Values)|-0.5||||0.02|TWO_SIDED|95.0|-1.0|-0.1|||t-test, 2 sided|||||-0.1|-1.0|0.02
70933069|NCT03387189|141366541|SUPERIORITY|Alpha - 0.05|Risk Difference (RD)|0.116||||0.1|TWO_SIDED|95.0|-0.01|0.24|||Fisher Exact|||||0.24|-0.01|0.10
70933070|NCT03387189|141366543|SUPERIORITY|Alpha - 0.05|Risk Difference (RD)|0.028||||0.81|TWO_SIDED|95.0|-0.12|17.8|||Fisher Exact|||||17.8|-0.12|0.81
70933071|NCT03387189|141366544|SUPERIORITY|Alpha - 0.05|Risk Ratio (RR)|0.01||||1|TWO_SIDED|95.0|-0.11|0.13|||Fisher Exact|||||0.13|-0.11|1.0
70933072|NCT02628626|141366573|SUPERIORITY|||||||0.85|||||||ANCOVA|||||||0.85
70933073|NCT02628626|141366574|SUPERIORITY|||||||0.24|||||||ANCOVA|||Approximately 4 weeks||||0.24
70933074|NCT02628626|141366575|SUPERIORITY|||||||0.44|||||||ANCOVA|||Approximately 4 weeks||||0.44
70933075|NCT02628626|141366576|SUPERIORITY|||||||0.35|||||||ANCOVA|||||||0.35
70933076|NCT02628626|141366577|SUPERIORITY|||||||0.56|||||||ANCOVA|||Approximately 4 weeks||||0.56
70933077|NCT02628626|141366578|SUPERIORITY|||||||0.55|||||||ANCOVA|||||||0.55
70933078|NCT02628626|141366579|SUPERIORITY|||||||0.11|||||||ANCOVA|||Small (staining only)||||0.11
71055029|NCT02784444|141613552|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.023|TWO_SIDED|95.0|-1.1|-0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||-0.1|-1.1|0.023
70933079|NCT02628626|141366579|SUPERIORITY|||||||0.06|||||||ANCOVA|||Moderate (requires change of underwear)||||0.06
70933080|NCT02628626|141366579|SUPERIORITY|||||||0.36|||||||ANCOVA|||Large (requires complete change of clothes)||||0.36
70933081|NCT02628626|141366580|SUPERIORITY|||||||0.18|||||||ANCOVA|||||||0.18
70933082|NCT02628626|141366581|SUPERIORITY|||||||0.04|||||||ANCOVA|||||||0.04
70933083|NCT02628626|141366582|SUPERIORITY|||||||0.29|||||||ANCOVA|||||||0.29
70933084|NCT02628626|141366583|SUPERIORITY|||||||0.39|||||||ANCOVA|||||||0.39
70933085|NCT02628626|141366584|SUPERIORITY|||||||0.07|||||||ANCOVA|||||||0.07
70933086|NCT02628626|141366585|SUPERIORITY|approximately 4 weeks post-treatment||||||0.12|||||||ANCOVA|||||||0.12
70933087|NCT02628626|141366586|SUPERIORITY|||||||0.67|||||||ANCOVA|||Lifestyle Score||||0.67
70933088|NCT02628626|141366586|SUPERIORITY|||||||0.8|||||||ANCOVA|||Coping Score||||0.80
70933089|NCT02628626|141366586|SUPERIORITY|||||||0.49|||||||ANCOVA|||Depression Score||||0.49
70933090|NCT02628626|141366586|SUPERIORITY|||||||0.6|||||||ANCOVA|||Embarrassment Score||||0.60
70933091|NCT02628626|141366587|SUPERIORITY|||||||0.78|||||||ANCOVA|||Approximately 4 weeks post-treatment||||0.78
70933092|NCT02063659|141366625|SUPERIORITY||Hodges-Lehman estimator of difference|-53.955|||<|0.001|TWO_SIDED|95.0|-84.955|-25.119|||Wilcoxon rank sum|||The primary analysis used a blocked 2-sample Wilcoxon rank sum statistic stratified by the u5-HIAA at randomization.|Mean difference is calculated as LX1606-Placebo.|-25.119|-84.955|< 0.001
70933093|NCT02063659|141366625|SUPERIORITY||Hodges-Lehman estimator of difference|-89.662|||<|0.001|TWO_SIDED|95.0|-113.104|-63.863|||Wilcoxon rank sum|||The primary analysis used a blocked 2-sample Wilcoxon rank sum statistic stratified by the u5-HIAA at randomization.|Mean difference is calculated as LX1606-Placebo.|-63.863|-113.104|< 0.001
70933094|NCT01532999|141366633|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks. Data structure involved repeated measures over time nested within participant, who in turn, was nested within a therapy group. Models included a random intercept, a random slope, and fixed effects for treatment condition, time, and the stratification variable (site). Rejection of the null hypothesis of no treatment effect if this interaction was statistically significant (two-tailed α = .05).||||0.5
70933095|NCT01532999|141366634|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks.||||0.57
70933096|NCT01532999|141366636|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks.||||0.4
70933097|NCT01532999|141366637|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks.||||0.8
70933098|NCT01532999|141366638|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks.||||0.4
70933099|NCT01532999|141366639|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks.||||0.35
70933100|NCT01532999|141366640|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Regression, Logistic|||Mixed effects logistic regression analysis.||||0.3
70933101|NCT01532999|141366641|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||Regression, Logistic|||Mixed effects logistic regression analysis.||||0.7
70933102|NCT05251363|141366675|SUPERIORITY||||||<|0.0001|||||||Exact binomial test|||Ho: SADE-free rate ≤ 87.5% Ha: SADE-free rate \> 87.5% Used an exact binomial test comparing the observed proportion (overall SADE-free rate through 3 months) to the performance goal of 87.5%. The lower, two-sided 95% confidence bound for the overall SADE-free rate must be greater than 87.5% to reject the null hypothesis (Ho), which would demonstrate evidence that the SADE-free rate is significantly higher than 87.5%.||||<0.0001
70933103|NCT05251363|141366676|SUPERIORITY||||||<|0.0001|||||||Exact binomial test|||H0: Implant Success Rate ≤ 80% Ha: Implant Success Rate \> 80% Used an exact binomial test comparing the observed proportion (implant success rate) to the performance goal of 80%. The lower, two-sided 95% confidence bound for the overall implant success rate must be greater than 80% to reject the null hypothesis (Ho), which would demonstrate evidence that the rate of successful Solia S LBBA implants is significantly higher than 80.0%.||||< 0.0001
70933104|NCT05251363|141366677|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||H0: Improvement in QOL Physical Function Scale ≤ 2.8 Ha: Improvement in QOL Physical Function Scale \> 2.8 Exact one-sample t-test comparing mean improvement in QOL from baseline to 12-mo post-implant to a goal of +2.8. The lower, two-sided 95% confidence bound for the improvement in QOL must be \> +2.8 to reject H0.||||<0.001
70933105|NCT01093612|141366689|OTHER||||||<|0.001|||||||Wilcoxon rank-sum|||||||<0.001
70933106|NCT01093612|141366690|OTHER||||||<|0.001|||||||Wilcoxon rank-sum|||||||<0.001
70933107|NCT03835754|141366691|OTHER|Confidence internal is 88.8%, upper bound limit 99.2%|Clopper Pearson exact confidence interva|96.0|||||TWO_SIDED|95.0|88.8|99.2||||||||99.2|88.8|
70933108|NCT02921555|141366698|SUPERIORITY||Mean Difference (Final Values)|16.2||||0.05|TWO_SIDED|95.0|||||Chi-squared|||||||0.05
70933109|NCT02921555|141366698|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
70933110|NCT05080777|141366763|EQUIVALENCE|Group, Time, and Group x Time effect tests were performed using MLM.||||||0.295||||||.P-value shown is based on the Group x Time F statistic used in multilevel modeling (MLM)|Multilevel modeling (MLM)|||Null hypothesis was that there would be no group differences, no time differences, and no group x time differences, in changes over time between the two treatment groups. Because this was a pilot and feasibility study, no power calculations were conducted.||||0.295
70933111|NCT05080777|141366764|EQUIVALENCE|Group, time, and group x time effect tests were performed using multilevel modeling (MLM).||||||0.57||||||P-value shown is based on the group x time F statistic used in MLM.|MLM|||Null hypothesis was that there would be no group differences, no time differences, and no group x time differences, in changes over time between the two treatment groups. Because this was a pilot and feasibility study, no power calculations were conducted.||||0.570
71021883|NCT04128696|141551604|OTHER||Difference in Percentage|-11.8|||||TWO_SIDED|95.0|-22.4|-1.1||||||The comparison between treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||-1.1|-22.4|
71021884|NCT04128696|141551605|OTHER||Difference in Percentage|-18.0|||||TWO_SIDED|95.0|-33.7|-1.4||||||The comparison between treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||-1.4|-33.7|
71021885|NCT04128696|141551614|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.783|TWO_SIDED|95.0|0.78|1.77||Nominal p-value was calculated based on the one-sided log-rank test, stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||1.77|0.78|0.783
71021886|NCT04128696|141551615|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.5|TWO_SIDED|95.0|0.5|2.0||Nominal p-value was calculated based on the log-rank test, stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the cox regression model with Efron's method of tie handling, a treatment covariate and stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||2.00|0.50|0.500
71055030|NCT02784444|141613552|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.028|TWO_SIDED|95.0|-1.0|-0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||-0.1|-1.0|0.028
71055031|NCT02784444|141613553|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.224|TWO_SIDED|95.0|-0.4|0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline steatosis.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.1|-0.4|0.224
71055032|NCT02784444|141613553|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.096|TWO_SIDED|95.0|-0.4|0.0||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline steatosis.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.0|-0.4|0.096
70933112|NCT05080777|141366765|EQUIVALENCE|Group, time, and time x group effect tests were performed using multilevel modeling (MLM).||||||0.461||||||P-value shown is based on the group x time F statistic used in MLM.|MLM|||Null hypothesis was that there would be no group differences, no time differences, and no group x time differences, in changes over time between the two treatment groups. Because this was a pilot and feasibility study, no power calculations were conducted.||||0.461
70933113|NCT00092534|141366852|SUPERIORITY_OR_OTHER_LEGACY||Percent relative risk reduction|96.6||||||95.0|88.2|99.6|||||Confidence Interval (CI) based on binomial tail probabilities and not from a dispersion parameter|||99.6|88.2|
70933114|NCT04001829|141366879|SUPERIORITY|||||||0.27|||||||Fisher Exact|||||||0.27
70933115|NCT04001829|141366880|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.96
70933116|NCT04001829|141366881|SUPERIORITY|||||||0.004|||||||Fisher Exact|||||||0.004
70933117|NCT04001829|141366882|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
70933118|NCT04001829|141366883|SUPERIORITY|||||||0.019|||||||Fisher Exact|||||||0.019
70933119|NCT04001829|141366884|SUPERIORITY|||||||0.47|||||||Fisher Exact|||||||0.47
70933120|NCT03678688|141366885|SUPERIORITY||EBA Ratio|0.689|||||TWO_SIDED|95.0|0.485|0.939|||||The confidence interval for the EBA ratio is estimated using Fieller's method.|||0.939|0.485|
71021887|NCT04128696|141551616|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.329|TWO_SIDED|95.0|0.62|1.34||Nominal p-value was calculated based on the one-sided log-rank test, stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||1.34|0.62|0.329
70933121|NCT03678688|141366885|SUPERIORITY||EBA Ratio|0.689|||||TWO_SIDED|95.0|0.467|0.911|||||The confidence interval for the EBA ratio is estimated using Taylor's method.|||0.911|0.467|
70933122|NCT03678688|141366885|SUPERIORITY||EBA Ratio|0.759|||||TWO_SIDED|95.0|0.517|1.051|||||The confidence interval for the EBA ratio is estimated using Fieller's method.|||1.051|0.517|
70933123|NCT03678688|141366885|SUPERIORITY||EBA Ratio|0.759|||||TWO_SIDED|95.0|0.497|1.02|||||The confidence interval for the EBA ratio is estimated using Taylor's method.|||1.020|0.497|
70933124|NCT03678688|141366885|SUPERIORITY||EBA Ratio|0.745|||||TWO_SIDED|95.0|0.567|0.973|||||The confidence interval for the EBA ratio is estimated using Fieller's method.|||0.973|0.567|
70933125|NCT03678688|141366885|SUPERIORITY||EBA Ratio|0.745|||||TWO_SIDED|95.0|0.547|0.943|||||The confidence interval for the EBA ratio is estimated using Taylor's method.|||0.943|0.547|
71055033|NCT02784444|141613553|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.007|TWO_SIDED|95.0|-0.6|-0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline steatosis.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||-0.1|-0.6|0.007
71055034|NCT02784444|141613554|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.488|TWO_SIDED|95.0|-0.1|0.2||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline inflammation.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.2|-0.1|0.488
70933126|NCT03678688|141366885|SUPERIORITY||EBA Ratio|0.605|||||TWO_SIDED|95.0|0.353|0.896|||||The confidence interval for the EBA ratio is estimated using Fieller's method.|||0.896|0.353|
70933127|NCT03678688|141366885|SUPERIORITY||EBA Ratio|0.605|||||TWO_SIDED|95.0|0.338|0.871|||||The confidence interval for the EBA ratio is estimated using Taylor's method.|||0.871|0.338|
70933128|NCT03678688|141366925|SUPERIORITY||EBA Ratio|1.256|||||TWO_SIDED|95.0|0.626|3.175|||||The confidence interval for the EBA ratio is estimated using Fieller's method.|||3.175|0.626|
70933129|NCT03678688|141366925|SUPERIORITY||EBA Ratio|1.256|||||TWO_SIDED|95.0|0.362|2.151|||||The confidence interval for the EBA ratio is estimated using Taylor's method.|||2.151|0.362|
70933130|NCT03678688|141366925|SUPERIORITY||EBA Ratio|1.385|||||TWO_SIDED|95.0|0.736|2.656|||||The confidence interval for the EBA ratio is estimated using Fieller's method.|||2.656|0.736|
70933131|NCT03678688|141366925|SUPERIORITY||EBA Ratio|1.385|||||TWO_SIDED|95.0|0.564|2.206|||||The confidence interval for the EBA ratio is estimated using Taylor's method.|||2.206|0.564|
70933132|NCT02949297|141366992|OTHER|One-sided Clopper-Pearson 95% confidence interval|Clopper-Pearson|80.0|||||ONE_SIDED|95.0||95.0|||||One-sided Clopper-Pearson 95% confidence interval|||95||
70933133|NCT00458783|141367007|SUPERIORITY||Odds Ratio (OR)|0.77||||0.08|TWO_SIDED|95.0|0.5|1.2|||generalized estimating equation (GEE)|Generalized estimating equation (GEE) distinct-effects model||||1.2|0.50|0.08
71055035|NCT02784444|141613554|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.291|TWO_SIDED|95.0|-0.3|0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline inflammation.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.1|-0.3|0.291
71055036|NCT02784444|141613554|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.595|TWO_SIDED|95.0|-0.2|0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline inflammation.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.1|-0.2|0.595
70933134|NCT00458783|141367008|SUPERIORITY||Odds Ratio, log|0.64|||||TWO_SIDED|95.0|0.25|1.6||||||||1.6|0.25|
70933135|NCT00458783|141367009|SUPERIORITY||Odds Ratio, log|0.72|||||TWO_SIDED|95.0|0.26|2.0||||||||2.0|0.26|
70933136|NCT00458783|141367010|SUPERIORITY||Odds Ratio, log|0.9|||||TWO_SIDED|95.0|0.59|1.4||||||||1.4|0.59|
70933137|NCT00458783|141367011|SUPERIORITY||Odds Ratio, log|0.86|||||TWO_SIDED|95.0|0.43|1.8||||||||1.8|0.43|
70933138|NCT00458783|141367012|SUPERIORITY||Risk Ratio, log|0.81|||||TWO_SIDED|95.0|0.24|2.8||||||||2.8|0.24|
70933139|NCT00458783|141367013|SUPERIORITY||Odds Ratio, log|1.1|||||TWO_SIDED|95.0|0.8|1.5||||||||1.5|0.80|
70933140|NCT00458783|141367014|SUPERIORITY||Odds Ratio, log|0.43|||||TWO_SIDED|95.0|0.16|1.1||||||||1.1|0.16|
70933141|NCT00458783|141367015|SUPERIORITY||Odds Ratio, log|0.82|||||TWO_SIDED|95.0|0.39|1.7||||||||1.7|0.39|
70933142|NCT00458783|141367016|SUPERIORITY||Odds Ratio, log|0.82|||||TWO_SIDED|95.0|0.5|1.3||||||||1.3|0.50|
70933143|NCT00458783|141367017|SUPERIORITY||Odds Ratio, log|0.76|||||TWO_SIDED|95.0|0.18|3.2||||||||3.2|0.18|
70933144|NCT00458783|141367018|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.9|TWO_SIDED|95.0|0.94|1.29|||Regression, Cox||The 95%CI is interim adjusted.|||1.29|0.94|0.9
70933145|NCT00458783|141367019|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.07|TWO_SIDED|95.0|0.85|1.18|||Regression, Cox||The 95%CI is interim adjusted.|||1.18|0.85|0.07
70933146|NCT01737398|141367020|OTHER||Least Square Mean Difference|-19.73||||4e-08|TWO_SIDED|95.0|-26.43|-13.03|||MMRM|||||-13.03|-26.43|0.00000004
70933147|NCT01737398|141367021|OTHER||Least Square Mean Difference|-11.68||||0.0006|TWO_SIDED|95.0|-18.29|-5.06|||MMRM|||||-5.06|-18.29|0.0006
70933148|NCT06307457|141367041|OTHER|||||||0.031|||||||Log Rank|||Statistical data for this outcome measure is provided combined for all age groups.||||0.031
70933149|NCT06307457|141367042|OTHER|||||||0.012|||||||Log Rank|||Statistical data for this outcome measure is provided combined for all age groups.||||0.012
70933150|NCT06307457|141367043|OTHER|||||||0.061|||||||Log Rank|||Statistical data for this outcome measure is provided combined for all CCI scores.||||0.061
70933151|NCT06307457|141367044|OTHER|||||||0.08|||||||Log Rank|||Statistical data for this outcome measure is provided combined for all CCI scores.||||0.080
70933152|NCT06307457|141367045|OTHER|||||||0.2|||||||Log Rank|||Statistical data for this outcome measure is provided combined for all number of comorbidities.||||0.2
70933153|NCT06307457|141367046|OTHER|||||||0.093|||||||Log Rank|||Statistical data for this outcome measure is provided combined for all number of comorbidities.||||0.093
70933154|NCT06307457|141367047|OTHER||||||>|0.9|||||||Log Rank|||Statistical data for participants with cardiac disease comorbidity reported.||||>0.9
71055037|NCT02784444|141613555|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.416|TWO_SIDED|95.0|-0.4|0.2||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline ballooning.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.2|-0.4|0.416
71055038|NCT02784444|141613555|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.056|TWO_SIDED|95.0|-0.5|0.0||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline ballooning.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.0|-0.5|0.056
71055039|NCT02784444|141613555|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.22|TWO_SIDED|95.0|-0.4|0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline ballooning.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.1|-0.4|0.220
71055040|NCT02784444|141613556|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.928|TWO_SIDED|95.0|-0.3|0.3||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 vs. F2/F3, and baseline CRN fibrosis staging score.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.3|-0.3|0.928
71055041|NCT02784444|141613556|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.244|TWO_SIDED|95.0|-0.5|0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 vs. F2/F3, and baseline CRN fibrosis staging score.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.1|-0.5|0.244
71055042|NCT02784444|141613556|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.228|TWO_SIDED|95.0|-0.5|0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 vs. F2/F3, and baseline CRN fibrosis staging score.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.1|-0.5|0.228
71055043|NCT04746794|141613593|SUPERIORITY|||||||0.0074|||||||Chi-squared|||||||0.0074
71055044|NCT04746794|141613594|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71055045|NCT04040192|141613600|OTHER|||||||0.0034||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||||||0.0034
71055046|NCT04040192|141613602|OTHER|Analysis of covariance (ANCOVA) model included fixed effects of treatment group, age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Least square mean difference|34.59|STANDARD_ERROR_OF_MEAN|16.274||0.0346|TWO_SIDED|95.0|2.53|66.64|||ANCOVA|||||66.64|2.53|0.0346
71055047|NCT04040192|141613603|OTHER||Median Difference (Final Values)|-0.5||||0.0042|TWO_SIDED|95.0|-1.0|0.0||p-value was estimated by Wilcoxon rank sum test stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Wilcoxon (Mann-Whitney)||Median difference and 95%CI were estimated using Hodges-Lehmann method.|||0.00|-1.00|0.0042
71055048|NCT04040192|141613604|OTHER|||||||0.6815||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||Baseline PP NRS \>=3 and \>=3 point reduction in PP NRS||||0.6815
70933155|NCT06307457|141367047|OTHER|||||||0.9|||||||Log Rank|||Statistical data for participants with vascular disease comorbidity reported.||||0.9
71021888|NCT04128696|141551617|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.608|TWO_SIDED|95.0|0.6|2.0||Nominal p-value was calculated based on the one-sided log-rank test, stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||2.00|0.60|0.608
71021889|NCT00951899|141551621|SUPERIORITY_OR_OTHER|||||||0.0006||95.0||||A P value \< 0.05 was considered statistically significant|t-test, 2 sided|||Comparison of mean total GLP-1 concentration from baseline to 12 weeks in Colesevelam subjects||||0.0006
71021890|NCT00951899|141551621|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||t-test, 2 sided|||Comparison of mean total GLP-1 concentration from baseline to 12 weeks in Placebo subjects||||0.30
71021891|NCT02557672|141551648|SUPERIORITY||Ratio of the Geometric Means|0.98||||0.84|TWO_SIDED|95.0|0.81|1.19|||Regression, Linear|||||1.19|0.81|0.84
71021892|NCT02557672|141551649|SUPERIORITY||Odds Ratio (OR)|0.49||||0.09|TWO_SIDED|95.0|0.22|1.11|||Regression, Logistic|||||1.11|0.22|0.09
71021893|NCT02557672|141551650|SUPERIORITY||Odds Ratio, log|0.76||||0.51|TWO_SIDED|95.0|0.33|1.73|||Regression, Logistic|||||1.73|0.33|0.51
71021894|NCT02557672|141551651|SUPERIORITY||Odds Ratio (OR)|1.39||||0.53|TWO_SIDED|95.0|0.51|3.79|||Regression, Logistic|||||3.79|0.51|0.53
71021895|NCT02557672|141551652|SUPERIORITY||Odds Ratio (OR)|0.52||||0.39|TWO_SIDED|95.0|0.12|2.3|||Regression, Logistic|||||2.30|0.12|0.39
70933156|NCT06307457|141367047|OTHER|||||||0.4|||||||Log Rank|||Statistical data for participants with metabolic disease comorbidity reported.||||0.4
71021896|NCT03705169|141551654|EQUIVALENCE|Confidence Interval (CI) on Geometric Mean Ratio.|Geometric Mean Ratio|3.2|||||TWO_SIDED|95.0|1.9|5.3|||||The ratios of the geometric means (Arm A/Arm C) and the corresponding 95% CI were obtained by exponentiating the least squares mean difference and its 95% CI of the natural log-transformed data.|As dose-normalized AUC 0-12WK values were considered, participants were pooled within Arm (i.e., Arm A participants receiving 1, 3, 10, or 30 mg/kg were pooled and Arm C participants 0.3 or 1.0 mg/kg were pooled).|No comparisons were done with Arm B participants, as only two participants in that arm had available measurements such that AUC 0-12WK could be estimated.|5.3|1.9|
71021897|NCT03705169|141551655|OTHER||Mean|-0.18||||0.26|TWO_SIDED|95.0|-0.53|0.18||Under the null hypothesis, it was assumed there was no change in HIV-1 RNA (log10 copies/mL) from baseline to Day 7 of SAR441236 monotherapy for viremic participants with HIV (Arm B cohorts).|t-test, 2 sided|||Arm B participants were pooled across doses for analysis.||0.18|-0.53|0.26
71021898|NCT03705169|141551657|OTHER||Mean|-0.02||||0.78|TWO_SIDED|95.0|-0.24|0.19||Under the null hypothesis, it was assumed there was no change in HIV-1 RNA (log10 copies/mL) from baseline to Day 14 of SAR441236 monotherapy for viremic participants with HIV (Arm B cohorts).|t-test, 2 sided|||Arm B participants were pooled across doses for analysis.||0.19|-0.24|0.78
70933157|NCT06307457|141367048|OTHER|||||||0.7|||||||Log Rank|||Statistical data for participants cardiac disease comorbidity reported.||||0.7
70933158|NCT06307457|141367048|OTHER|||||||0.3|||||||Log Rank|||Statistical data for participants with vascular disease comorbidity reported.||||0.3
71021899|NCT01681771|141551710|SUPERIORITY|||||||0.21|||||||ANCOVA|ANCOVA analysis comparing PHQ-9 mean values at 9 weeks follow-up between the I-CBT and discussion group and adjusting for PHQ-9 values baseline||||||0.21
71021900|NCT03154333|141551711|OTHER||Risk Ratio (RR)|1.01||||0.9666|TWO_SIDED|95.0|0.63|1.62|||Cochran-Mantel-Haenszel|Log transformation normalized the Risk Ratio (RR) estimates; the Standard Error (SE) of the estimate was obtained from confidence limits for the RR.||||1.62|0.63|0.9666
71021901|NCT03154333|141551712|OTHER||Risk Ratio (RR)|1.53||||0.2861|TWO_SIDED|95.0|0.41|3.28|||Cochran-Mantel-Haenszel|Log transformation normalized the Risk Ratio (RR) estimates; the Standard Error (SE) of the estimate was obtained from confidence limits for the RR.||||3.28|0.41|0.2861
71021902|NCT00361257|141551713|SUPERIORITY_OR_OTHER||Slope|0.064|STANDARD_ERROR_OF_MEAN|0.164||0.651|TWO_SIDED|95.0|-0.258|0.386||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratification variables, the CNS penetration score, and the baseline NPZ-8 score.|The total number used for the statistical analysis was 107 (52 in the minocycline arm and 55 in the placebo arm).|The null hypothesis was that the 24-week change of NPZ-8 in the minocycline group was the same as the one in the placebo group.||0.386|-0.258|0.651
71021903|NCT00361257|141551714|SUPERIORITY_OR_OTHER||Slope|0.091|STANDARD_ERROR_OF_MEAN|0.116||0.434|TWO_SIDED|95.0|-0.14|0.323||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratification variables, the CNS penetration score, and the baseline GDS score.||The null hypothesis was that the 24-week changes in Global Deficit Score (GDS) between the minocycline and placebo groups are the same.||0.323|-0.140|0.434
71021904|NCT00361257|141551715|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.569|STANDARD_DEVIATION|0.469||0.337|TWO_SIDED|95.0|0.625|3.936||The p-value was not adjusted for multiple comparisons.|Regression, Cumulative Logistic|The model was adjusted for the stratification variables and the CNS penetration score.||The null hypothesis is that the 24 week changes of participants' clinical status in the minocycline group were the same as the ones in the placebo group based on ICGIS.||3.936|0.625|0.337
71021905|NCT00361257|141551716|SUPERIORITY_OR_OTHER||Slope|0.502|STANDARD_ERROR_OF_MEAN|0.428||0.243|TWO_SIDED|95.0|-0.349|1.354||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the CNS penetration score, and the baseline cognitive gross motor function domain score.||The null hypothesis is that the 24 week change in the cognitive gross motor function domain score in the minocycline group is the same as the one in the placebo group.||1.354|-0.349|0.243
70933159|NCT06307457|141367048|OTHER|||||||0.7|||||||Log Rank|||Statistical data for participants with metabolic disease comorbidity reported.||||0.7
71021906|NCT00361257|141551717|SUPERIORITY_OR_OTHER||Slope|0.293|STANDARD_ERROR_OF_MEAN|0.153||0.059|TWO_SIDED|95.0|-0.011|0.596||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the CNS penetration score, and the baseline fine motor function domain score.||The null hypothesis was that the 24 week change in fine motor function domain score in the minocycline group was the same as the one in the placebo group.||0.596|-0.011|0.059
71021907|NCT00361257|141551718|SUPERIORITY_OR_OTHER||Slope|-0.083|STANDARD_ERROR_OF_MEAN|0.147||0.572|TWO_SIDED|95.0|-0.375|0.209||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratified variables, the baseline CNS penetration score, and the baseline psychomotor function domain score.||The null hypothesis was that the 24 change of psychomotor function domain score in the minocycline group is the same as in the placebo group.||0.209|-0.375|0.572
71021908|NCT00361257|141551719|SUPERIORITY_OR_OTHER||Slope|-0.086|STANDARD_ERROR_OF_MEAN|0.182||0.637|TWO_SIDED|95.0|-0.449|0.276||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the CNS penetration score, and the baseline fine motor/nonverbal function domain score.||The null hypothesis was that the 24 week change of fine motor/nonverbal function domain score in the minocycline group was the same as in the placebo group.||0.276|-0.449|0.637
71021909|NCT00361257|141551720|SUPERIORITY_OR_OTHER||Slope|-0.074|STANDARD_ERROR_OF_MEAN|0.236||0.754|TWO_SIDED|95.0|-0.544|0.396||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the CNS penetration score, and the baseline information processing function domain score.||The null hypothesis was that the 24 week change of information processing function domain score in the minocycline group was the same as the one in the placebo group.||0.396|-0.544|0.754
71021910|NCT00361257|141551721|SUPERIORITY_OR_OTHER||Slope|0.145|STANDARD_ERROR_OF_MEAN|0.207||0.484|TWO_SIDED|95.0|-0.266|0.558||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline verbal memory domain score.||The null hypothesis was that the 24 week change of verbal memory domain score in the minocycline group was the same as the one in the placebo group.||0.558|-0.266|0.484
71021911|NCT00361257|141551722|SUPERIORITY_OR_OTHER||Slope|-0.126|STANDARD_ERROR_OF_MEAN|0.172||0.467|TWO_SIDED|95.0|-0.467|0.216||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline frontal systems function domain score.||The null hypothesis was that the 24 week change of frontal systems function domain score in the minocycline group was the same as the one in the placebo group.||0.216|-0.467|0.467
71021912|NCT00361257|141551723|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.476|STANDARD_DEVIATION|1.048||0.234|TWO_SIDED|95.0|0.575|10.668||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the CNS penetration score. The stratification variables could not be included in the model since the model fit was poor.||"The null hypothesis was that the proportion of being better at 24 weeks in minocycline group was the same as in the placebo group."||10.668|0.575|0.234
71021913|NCT00361257|141551724|SUPERIORITY_OR_OTHER||Slope|19.09|STANDARD_ERROR_OF_MEAN|33.75||0.574|TWO_SIDED|95.0|-48.26|86.44||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratification variables, the baseline CNS score, and the baseline CD4 cell count.||The null hypothesis was that the 24 week change in CD4 cell counts in the minocycline group was the same as the one in the placebo group.||86.44|-48.26|0.574
71021914|NCT00361257|141551725|SUPERIORITY_OR_OTHER||Slope|40.43|STANDARD_ERROR_OF_MEAN|59.91||0.502|TWO_SIDED|95.0|-79.12|159.97||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline CD8 cell counts.||The null hypothesis was that the 24 week change in CD8 cell count in the minocycline group was the same as the one in the placebo group.||159.97|-79.12|0.502
71021915|NCT00361257|141551726|SUPERIORITY_OR_OTHER|||||||0.967||95.0|||||Log Rank|||The null hypothesis was that the time to Grade 2 or higher toxicity and/or signs and symptoms in the minocycline group was the same as the one in the placebo group.||||0.967
71055049|NCT04040192|141613604|OTHER|||||||0.1518||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||Baseline PP NRS \>=4 and \>=4 point reduction in PP NRS||||0.1518
71055050|NCT04040192|141613605|OTHER|||||||0.1933||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization|Log Rank|||||||0.1933
71055051|NCT04040192|141613606|OTHER|p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization||||||0.3778|||||||Log Rank|||Baseline ORIS Scale \>=3 and \>=3 point reduction||||0.3778
71055052|NCT04040192|141613606|OTHER|p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization||||||0.487|||||||Log Rank|||Baseline ORIS Scale \>=4 and \>=4 point reduction||||0.4870
71055053|NCT04040192|141613607|OTHER|||||||0.1159||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||||||0.1159
71055054|NCT04040192|141613608|OTHER|||||||0.6973||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||DLQI for participants \>=16 years of age||||0.6973
70933160|NCT06307457|141367049|OTHER|||||||0.005|||||||Log Rank|||Statistical data for this outcome measure is provided combined for visceral disease status.||||0.005
70933161|NCT06307457|141367050|OTHER|||||||0.005|||||||Log Rank|||Statistical data for this outcome measure is provided combined for visceral disease status.||||0.005
70933162|NCT06307457|141367051|OTHER|||||||0.14|||||||Log Rank|||Statistical data for this outcome measure is provided combined for bone disease status.||||0.14
70933163|NCT06307457|141367052|OTHER|||||||0.2|||||||Log Rank|||Statistical data for this outcome measure is provided combined for bone disease status.||||0.2
70933164|NCT06307457|141367053|OTHER|||||||0.047|||||||Log Rank|||Statistical data for this outcome measure is provided combined for endocrine status.||||0.047
70933165|NCT06307457|141367054|OTHER|||||||0.041|||||||Log Rank|||Statistical data for this outcome measure is provided combined for endocrine status.||||0.041
70933166|NCT02962284|141367056|SUPERIORITY||||||>|0.1|||||||ANCOVA|||||||>0.1
70933167|NCT00357994|141367063|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-1.91|STANDARD_ERROR_OF_MEAN|0.57||0.0015|TWO_SIDED|95.0|-3.05|-0.76||Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline and the natural logarithm of the mean daily dose of rescue medication on valid symptom diary days as covariates.|ANCOVA|||||-0.76|-3.05|0.0015
70933168|NCT00357994|141367064|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|1.86|STANDARD_ERROR_OF_MEAN|0.65||0.0059|TWO_SIDED|95.0|0.56|3.17|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||3.17|0.56|0.0059
70933169|NCT00357994|141367065|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-7.0|STANDARD_ERROR_OF_MEAN|2.8||0.0155|TWO_SIDED|95.0|-12.6|-1.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||-1.4|-12.6|0.0155
70933170|NCT00357994|141367066|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0258|TWO_SIDED|95.0|-1.4|-0.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the baseline CGI-S as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||-0.1|-1.4|0.0258
71021916|NCT00361257|141551728|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.071|STANDARD_ERROR_OF_MEAN|0.497||0.89|TWO_SIDED|95.0|0.405|2.837||The p-value was not adjusted for multiple comparisons.|Regression, Logistic|The model was adjusted for the stratification variables and the baseline CNS penetration score.||The null hypothesis was that the proportion of participants who got better at week 24 compared to baseline in the minocycline group was the same as the one in the placebo group.||2.837|0.405|0.890
71055055|NCT04040192|141613608|OTHER|||||||0.7456||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||Children's DLQI: participants 4-\<16 yrs of age||||0.7456
71055056|NCT04040192|141613609|OTHER|||||||0.0513||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||POEM||||0.0513
71055057|NCT04040192|141613609|OTHER|||||||0.0217||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||Proxy POEM||||0.0217
71055058|NCT03200912|141613702|EQUIVALENCE|Primary Efficacy Endpoint - AK Complete Clearance Rates at Day 57 (PP and mITT Populations)|Mean Difference (Net)|2.29|||||TWO_SIDED|90.0|-7.55|12.14||||||||12.14|-7.55|
70933171|NCT00357994|141367067|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-3.0|STANDARD_ERROR_OF_MEAN|1.1||0.0086|TWO_SIDED|95.0|-5.3|-0.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||-0.8|-5.3|0.0086
70933172|NCT00357994|141367068|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|1.4|STANDARD_ERROR_OF_MEAN|2.1||0.502|TWO_SIDED|95.0|-2.8|5.6|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||5.6|-2.8|0.5020
70933173|NCT00357994|141367069|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|0.07|STANDARD_ERROR_OF_MEAN|0.038||0.067|TWO_SIDED|95.0|-0.005|0.146|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding Baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||0.146|-0.005|0.0670
70933174|NCT00357994|141367070|SUPERIORITY_OR_OTHER||Treament Difference (LS Mean)|-4.5|STANDARD_ERROR_OF_MEAN|3.1||0.1501|TWO_SIDED|95.0|-10.7|1.7|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||1.7|-10.7|0.1501
71077925|NCT02913105|141664399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.98||||0.6237|TWO_SIDED|90.0|0.93|1.04|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 14||1.04|0.93|0.6237
70933175|NCT00357994|141367071|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-0.08|STANDARD_ERROR_OF_MEAN|0.45||0.8574|TWO_SIDED|95.0|-0.98|0.82|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||0.82|-0.98|0.8574
71021917|NCT00361257|141551729|SUPERIORITY_OR_OTHER||Slope|-0.405|STANDARD_ERROR_OF_MEAN|0.391||0.304|TWO_SIDED|95.0|-1.182|0.373||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline medication management score.||The null hypothesis was that the 24 change of medication management test score in the minocycline group was the same as the one in the placebo group.||0.373|-1.182|0.304
71021918|NCT00361257|141551734|SUPERIORITY_OR_OTHER||Slope|-0.097|STANDARD_ERROR_OF_MEAN|0.146||0.506|TWO_SIDED|95.0|-0.388|0.193||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline alternate psychomotor function score.||The null hypothesis was that the 24 week change in alternate psychomotor function score in the minocycline group was the same as the one in the placebo group.||0.193|-0.388|0.506
71021919|NCT00361257|141551735|SUPERIORITY_OR_OTHER||Slope|0.146|STANDARD_ERROR_OF_MEAN|0.207||0.484|TWO_SIDED|95.0|-0.266|0.558||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratification variables, baseline CNS penetration score, and the baseline alternate verbal memory score.||The null hypothesis was that the 24 week change in the alternate verbal memory score in the minocycline group was the same as the one in the placebo group.||0.558|-0.266|0.484
71021920|NCT00361257|141551736|SUPERIORITY_OR_OTHER||Slope|0.055|STANDARD_ERROR_OF_MEAN|0.137||0.69|TWO_SIDED|95.0|-0.217|0.327||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratification variables, baseline CNS penetration score, and the baseline alternate frontal systems score.||The null hypothesis was the 24 week change of alternate frontal systems score in the minocycline group was the same as the one in the placebo group.||0.327|-0.217|0.690
71021921|NCT02919475|141551740|SUPERIORITY|||||||0.842|||||||Fisher Exact|||||||0.842
71021922|NCT02919475|141551740|SUPERIORITY|||||||0.841|||||||Fisher Exact|||||||0.841
71021923|NCT02919475|141551740|SUPERIORITY|||||||0.842|||||||Fisher Exact|||||||0.842
71021924|NCT02919475|141551740|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
71021925|NCT02919475|141551741|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
71021926|NCT02919475|141551741|SUPERIORITY|||||||0.832|||||||Fisher Exact|||||||0.832
71021927|NCT02919475|141551741|SUPERIORITY|||||||0.682|||||||Fisher Exact|||||||0.682
71021928|NCT02919475|141551741|SUPERIORITY|||||||0.665|||||||Fisher Exact|||||||0.665
71021929|NCT02919475|141551742|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
71055059|NCT01955083|141613707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.0|STANDARD_DEVIATION|16.0|<|0.05|TWO_SIDED|95.0|-14.4|48.4|||Wilcoxon (Mann-Whitney)|||We hypothesized that pillar implant provide a better efficacy in the treatment of snoring than radiofrequency surgery. The sample size was estimated using the primary outcome effects (VAS) in two previously published studies (Friedman 2008; Fang 2004). Using a two-tailed Wilcoxon signed-rank test (normal parent distribution; effect size, 1.0; type I error, 0.05; power, 80%), we got a sample size of 11. For considering a 20% drop-out rate, we needed at least 14 participants.||48.4|-14.4|<0.05
71055060|NCT01955083|141613708|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71021930|NCT02919475|141551742|SUPERIORITY|||||||0.627|||||||Fisher Exact|||||||0.627
71055061|NCT01955083|141613709|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71021931|NCT02919475|141551742|SUPERIORITY|||||||0.794|||||||Fisher Exact|||||||0.794
71021932|NCT02919475|141551742|SUPERIORITY|||||||0.453|||||||Fisher Exact|||||||0.453
71021933|NCT02919475|141551743|SUPERIORITY|||||||0.113|||||||Fisher Exact|||||||0.113
71021934|NCT02919475|141551743|SUPERIORITY|||||||0.024|||||||Fisher Exact|||||||0.024
71021935|NCT02919475|141551743|SUPERIORITY|||||||0.056|||||||Fisher Exact|||||||0.056
71021936|NCT02919475|141551743|SUPERIORITY|||||||0.035|||||||Fisher Exact|||||||0.035
71021937|NCT00775983|141551760|NON_INFERIORITY_OR_EQUIVALENCE|Power: We assumed a standard deviation of five minutes based on historical clinic data for surgical abortions during this gestational duration range, a non-inferiority margin of five minutes, and a 10% potential attrition rate to power the study for a non-inferiority hypothesis. Thirty participants in each arm gave us 95% power to conclude non-inferiority of same day Dilapan-S compared to overnight laminaria with respect to procedure time of surgical abortions between 14-18 weeks gestation.|Mean Difference (Final Values)|2.1|||||TWO_SIDED|97.5|-0.3|4.5|||t-test, 2 sided|||Null Hypothesis: A surgical abortion performed between 14-18 weeks gestation performed after the cervix has been prepared with same-day Dilapan-S is inferior with respect to procedure time, which is specifically outside a five minute margin of non-inferiority, when compared to procedures during the same gestational duration range performed after the cervix has been prepared overnight with laminaria.||4.5|-0.3|
71021938|NCT01663714|141551787|SUPERIORITY_OR_OTHER||percentage of participants|100.0|||||TWO_SIDED|95.0|100.0|100.0|||||The estimated value represents the percentage of participants with unconfirmed response.|||100|100|
71021939|NCT01663714|141551788|SUPERIORITY_OR_OTHER||percentage of participants|100.0|||||TWO_SIDED|95.0|100.0|100.0|||||The estimated value represents the percentage of participants with confirmed response.|||100|100|
71055062|NCT01955083|141613710|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71055063|NCT01955083|141613711|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71055064|NCT01955083|141613712|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71055065|NCT01955083|141613713|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71055066|NCT01955083|141613714|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71106946|NCT03710889|141720458|OTHER|Within treatment paired t-tests were used to compare the differences in dynamic indices between Baseline and Month 3 using the Bone-Biopsy Population. If the normality assumption is not satisfied at the 0.01 significance level and visual inspection of the data deems it necessary, Wilcoxon signed-rank test is used. No adjustments for multiplicity were made. A 2-sided p-value \<0.05 was considered statistically significant.|||||<|0.0001|||||||Paired t-test, 2 sided|||||||<0.0001
70933176|NCT00357994|141367072|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-10.4|STANDARD_ERROR_OF_MEAN|4.3||0.0184|TWO_SIDED|95.0|-19.1|-1.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-1.8|-19.1|0.0184
71021940|NCT00597584|141551809|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 95% confidence interval for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ -1.0 g/dL.|Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.078|||TWO_SIDED|95.0|-0.05|0.26|||ANOVA|The ANOVA cell means model was used to estimate primary efficacy endpoint within the specified cells formed by the combination of treatment and strata||The sample size for this study has been determined based on a two group evaluation of non-inferiority using the t-distribution (one-sided significance level 0.025) with a non inferiority margin of -1.0 g/dL. A sample size of approximately 750 (peginesatide group of 500 and epoetin group of 250) provided at least 99% power for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a standard deviation of 1.5 g/dL.||0.26|-0.05|
71106947|NCT04881760|141720465|SUPERIORITY||LS Mean difference (Final Values)|-5.64|||<|0.001|TWO_SIDED|95.0|-7.34|-3.94|||Mixed Models Analysis|||||-3.94|-7.34|<0.001
71106948|NCT04881760|141720465|SUPERIORITY||LS Mean difference (Final Values)|-10.45|||<|0.001|TWO_SIDED|95.0|-12.21|-8.7|||Mixed Models Analysis|||||-8.70|-12.21|<0.001
71106949|NCT04881760|141720465|SUPERIORITY||LS Mean difference (Final Values)|-12.25|||<|0.001|TWO_SIDED|95.0|-14.42|-10.08|||Mixed Models Analysis|||||-10.08|-14.42|<0.001
71106950|NCT04881760|141720465|SUPERIORITY||LS Mean difference (Final Values)|-15.1|||<|0.001|TWO_SIDED|95.0|-16.9|-13.3|||Mixed Models Analysis|||||-13.30|-16.90|<0.001
71106951|NCT04881760|141720465|SUPERIORITY||LS Mean difference (Final Values)|-16.72|||<|0.001|TWO_SIDED|95.0|-18.86|-14.58|||Mixed Models Analysis|||||-14.58|-18.86|<0.001
71106952|NCT04881760|141720465|SUPERIORITY||LS Mean difference (Final Values)|-15.85|||<|0.001|TWO_SIDED|95.0|-17.57|-14.13|||Mixed Models Analysis|||||-14.13|-17.57|<0.001
71106953|NCT04881760|141720466|SUPERIORITY||LS Mean difference (Final Values)|-6.57|||<|0.001|TWO_SIDED|95.0|-8.94|-4.2|||Mixed Models Analysis|||||-4.20|-8.94|<0.001
71106954|NCT04881760|141720466|SUPERIORITY||LS Mean difference (Final Values)|-14.21|||<|0.001|TWO_SIDED|95.0|-17.64|-10.78|||Mixed Models Analysis|||||-10.78|-17.64|<0.001
71106955|NCT04881760|141720466|SUPERIORITY||LS Mean difference (Final Values)|-15.72|||<|0.001|TWO_SIDED|95.0|-19.05|-12.4|||Mixed Models Analysis|||||-12.40|-19.05|<0.001
71106956|NCT04881760|141720466|SUPERIORITY||LS Mean difference (Final Values)|-19.62|||<|0.001|TWO_SIDED|95.0|-22.73|-16.51|||Mixed Models Analysis|||||-16.51|-22.73|<0.001
71106957|NCT04881760|141720466|SUPERIORITY||LS Mean difference (Final Values)|-21.78|||<|0.001|TWO_SIDED|95.0|-25.05|-18.51|||Mixed Models Analysis|||||-18.51|-25.05|<0.001
70933177|NCT00357994|141367073|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-11.6|STANDARD_ERROR_OF_MEAN|4.5||0.0129|TWO_SIDED|95.0|-20.6|-2.5|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-2.5|-20.6|0.0129
71021941|NCT00597584|141551810|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.5|1.24|||Cochran-Mantel-Haenszel|||||1.24|0.50|
71106958|NCT04881760|141720466|SUPERIORITY||LS Mean difference (Final Values)|-22.11|||<|0.001|TWO_SIDED|95.0|-24.92|-19.31|||Mixed Models Analysis|||||-19.31|-24.92|<0.001
71106959|NCT04881760|141720467|SUPERIORITY||Risk Difference (RD)|33.0|||<|0.001|TWO_SIDED|95.0|17.0|49.0|||Regression, Logistic|||||49|17|<0.001
71106960|NCT04881760|141720467|SUPERIORITY||Risk Difference (RD)|61.0|||<|0.001|TWO_SIDED|95.0|45.0|77.0|||Regression, Logistic|||||77|45|<0.001
71106961|NCT04881760|141720467|SUPERIORITY||Risk Difference (RD)|68.0|||<|0.001|TWO_SIDED|95.0|54.0|81.0|||Regression, Logistic|||||81|54|<0.001
71106962|NCT04881760|141720467|SUPERIORITY||Risk Difference (RD)|74.0|||<|0.001|TWO_SIDED|95.0|63.0|85.0|||Regression, Logistic|||||85|63|<0.001
71106963|NCT04881760|141720467|SUPERIORITY||Risk Difference (RD)|74.0|||<|0.001|TWO_SIDED|95.0|63.0|85.0|||Regression, Logistic|||||85|63|<0.001
71106964|NCT04881760|141720467|SUPERIORITY||Risk Difference (RD)|71.0|||<|0.001|TWO_SIDED|95.0|59.0|82.0|||Regression, Logistic|||||82|59|<0.001
71021942|NCT00597584|141551811|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.87|1.07|||Cochran-Mantel-Haenszel|||||1.07|0.87|
71106965|NCT04881760|141720468|SUPERIORITY||Risk Difference (RD)|37.0|||<|0.001|TWO_SIDED|95.0|20.0|54.0|||Regression, Logistic|||||54|20|<0.001
71106966|NCT04881760|141720468|SUPERIORITY||Risk Difference (RD)|60.0|||<|0.001|TWO_SIDED|95.0|44.0|76.0|||Regression, Logistic|||||76|44|<0.001
71106967|NCT04881760|141720468|SUPERIORITY||Risk Difference (RD)|70.0|||<|0.001|TWO_SIDED|95.0|57.0|83.0|||Regression, Logistic|||||83|57|<0.001
71106968|NCT04881760|141720468|SUPERIORITY||Risk Difference (RD)|73.0|||<|0.001|TWO_SIDED|95.0|62.0|84.0|||Regression, Logistic|||||84|62|<0.001
71106969|NCT04881760|141720468|SUPERIORITY||Risk Difference (RD)|73.0|||<|0.001|TWO_SIDED|95.0|62.0|84.0|||Regression, Logistic|||||84|62|<0.001
71106970|NCT04881760|141720468|SUPERIORITY||Risk Difference (RD)|73.0|||<|0.001|TWO_SIDED|95.0|67.0|84.0|||Regression, Logistic|||||84|67|<0.001
71106971|NCT04881760|141720469|SUPERIORITY||Risk Difference (RD)|22.0|||<|0.001|TWO_SIDED|95.0|11.0|33.0|||Regression, Logistic|||||33|11|<0.001
71106972|NCT04881760|141720469|SUPERIORITY||Risk Difference (RD)|56.0|||<|0.001|TWO_SIDED|95.0|38.0|73.0|||Regression, Logistic|||||73|38|<0.001
71106973|NCT04881760|141720469|SUPERIORITY||Risk Difference (RD)|69.0|||<|0.001|TWO_SIDED|95.0|53.0|85.0|||Regression, Logistic|||||85|53|<0.001
71106974|NCT04881760|141720469|SUPERIORITY||Risk Difference (RD)|80.0|||<|0.001|TWO_SIDED|95.0|66.0|93.0|||Regression, Logistic|||||93|66|<0.001
71106975|NCT04881760|141720469|SUPERIORITY||Risk Difference (RD)|91.0|||<|0.001|TWO_SIDED|95.0|83.0|100.0|||Regression, Logistic|||||100|83|<0.001
71106976|NCT04881760|141720469|SUPERIORITY||Risk Difference (RD)|87.0|||<|0.001|TWO_SIDED|95.0|78.0|96.0|||Regression, Logistic|||||96|78|<0.001
71106977|NCT04881760|141720470|SUPERIORITY||Risk Difference (RD)|18.0||||0.008|TWO_SIDED|95.0|5.0|31.0|||Regression, Logistic|||||31|5|0.008
71106978|NCT04881760|141720470|SUPERIORITY||Risk Difference (RD)|64.0|||<|0.001|TWO_SIDED|95.0|48.0|81.0|||Regression, Logistic|||||81|48|<0.001
71106979|NCT04881760|141720470|SUPERIORITY||Risk Difference (RD)|67.0|||<|0.001|TWO_SIDED|95.0|51.0|84.0|||Regression, Logistic|||||84|51|<0.001
70933178|NCT00357994|141367074|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-2.2|STANDARD_ERROR_OF_MEAN|3.4||0.5246|TWO_SIDED|95.0|-9.0|4.6|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||4.6|-9.0|0.5246
70933179|NCT00357994|141367075|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-4.5|STANDARD_ERROR_OF_MEAN|3.8||0.2423|TWO_SIDED|95.0|-12.0|3.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||3.1|-12.0|0.2423
70933180|NCT00357994|141367076|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-3.8|STANDARD_ERROR_OF_MEAN|3.1||0.2243|TWO_SIDED|95.0|-9.9|2.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||2.4|-9.9|0.2243
70933181|NCT00357994|141367077|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-4.0|STANDARD_ERROR_OF_MEAN|3.4||0.2407|TWO_SIDED|95.0|-10.8|2.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||2.8|-10.8|0.2407
70933182|NCT00357994|141367078|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-13.8|STANDARD_ERROR_OF_MEAN|3.5||0.0002|TWO_SIDED|95.0|-20.8|-6.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-6.8|-20.8|0.0002
71106980|NCT04881760|141720470|SUPERIORITY||Risk Difference (RD)|81.0|||<|0.001|TWO_SIDED|95.0|69.0|94.0|||Regression, Logistic|||||94|69|<0.001
70933183|NCT00357994|141367079|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-3.3|STANDARD_ERROR_OF_MEAN|5.1||0.5213|TWO_SIDED|95.0|-13.6|6.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||6.9|-13.6|0.5213
70933184|NCT00357994|141367080|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3741|TWO_SIDED|95.0|-0.4|0.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||0.9|-0.4|0.3741
70933185|NCT00357994|141367081|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-1.2|STANDARD_ERROR_OF_MEAN|0.6||0.0361|TWO_SIDED|95.0|-2.4|-0.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-0.1|-2.4|0.0361
70933186|NCT00357994|141367082|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-0.4|STANDARD_ERROR_OF_MEAN|0.4||0.3578|TWO_SIDED|95.0|-1.1|0.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||0.4|-1.1|0.3578
70933187|NCT00357994|141367083|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-1.5|STANDARD_ERROR_OF_MEAN|2.9||0.6088|TWO_SIDED|95.0|-7.4|4.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||4.4|-7.4|0.6088
70933188|NCT00357994|141367084|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|11.4|STANDARD_ERROR_OF_MEAN|3.7||0.0033|TWO_SIDED|95.0|4.0|18.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||18.9|4.0|0.0033
70933189|NCT01354444|141367087|OTHER||Coefficient|1.48||||0.565|TWO_SIDED|95.0|-3.796|6.761|||Regression, Linear|||This analysis compares immediate recall before and after 6 months between the treatment and placebo group.||6.761|-3.796|0.565
70933190|NCT01354444|141367088|OTHER|||||||0.481|||||||Rank sum test|||This analysis compares the change in total Tau between the treatment and placebo group from baseline to 6 months later.||||0.481
70933191|NCT01354444|141367088|OTHER|||||||0.0562|||||||Rank sum test|||This analysis compares the change in Abeta42 between the treatment and placebo group from baseline to 6 months later.||||0.0562
70933192|NCT01354444|141367088|OTHER|||||||0.314|||||||Rank sum test|||This analysis compares the change in p-tau between the treatment and placebo group from baseline to 6 months later.||||0.314
70933193|NCT01354444|141367088|OTHER|||||||0.438|||||||Rank sum test|||This analysis compares the change in oligomeric Abeta between the treatment and placebo group from baseline to 6 months later.||||0.438
71106981|NCT04881760|141720470|SUPERIORITY||Risk Difference (RD)|82.0|||<|0.001|TWO_SIDED|95.0|71.0|94.0|||Regression, Logistic|||||94|71|<0.001
71106982|NCT04881760|141720470|SUPERIORITY||Risk Difference (RD)|84.0|||<|0.001|TWO_SIDED|95.0|74.0|94.0|||Regression, Logistic|||||94|74|<0.001
71106983|NCT04881760|141720471|SUPERIORITY||Risk Difference (RD)|9.0||||0.029|TWO_SIDED|95.0|1.0|17.0|||Regression, Logistic|||||17|1|0.029
71106984|NCT04881760|141720471|SUPERIORITY||Risk Difference (RD)|27.0|||<|0.001|TWO_SIDED|95.0|11.0|43.0|||Regression, Logistic|||||43|11|<0.001
70933194|NCT00982072|141367090|OTHER|||||||0.12|||||||Fisher Exact|||||||0.12
71106985|NCT04881760|141720471|SUPERIORITY||Risk Difference (RD)|43.0|||<|0.001|TWO_SIDED|95.0|26.0|60.0|||Regression, Logistic|||||60|26|<0.001
71106986|NCT04881760|141720471|SUPERIORITY||Risk Difference (RD)|49.0|||<|0.001|TWO_SIDED|95.0|33.0|66.0|||Regression, Logistic|||||66|33|<0.001
71106987|NCT04881760|141720471|SUPERIORITY||Risk Difference (RD)|67.0|||<|0.001|TWO_SIDED|95.0|51.0|83.0|||Regression, Logistic|||||83|51|<0.001
71106988|NCT04881760|141720471|SUPERIORITY||Risk Difference (RD)|68.0|||<|0.001|TWO_SIDED|95.0|56.0|80.0|||Regression, Logistic|||||80|56|<0.001
71106989|NCT04881760|141720472|SUPERIORITY||Risk Difference (RD)|15.0||||0.002|TWO_SIDED|95.0|6.0|24.0|||Regression, Logistic|||||24|6|0.002
71106990|NCT04881760|141720472|SUPERIORITY||Risk Difference (RD)|53.0|||<|0.001|TWO_SIDED|95.0|36.0|70.0|||Regression, Logistic|||||70|36|<0.001
71106991|NCT04881760|141720472|SUPERIORITY||Risk Difference (RD)|63.0|||<|0.001|TWO_SIDED|95.0|47.0|79.0|||Regression, Logistic|||||79|47|<0.001
71106992|NCT04881760|141720472|SUPERIORITY||Risk Difference (RD)|71.0|||<|0.001|TWO_SIDED|95.0|55.0|87.0|||Regression, Logistic|||||87|55|<0.001
71106993|NCT04881760|141720472|SUPERIORITY||Risk Difference (RD)|75.0|||<|0.001|TWO_SIDED|95.0|62.0|89.0|||Regression, Logistic|||||89|62|<0.001
71055067|NCT01955083|141613715|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71055068|NCT01955083|141613716|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71055069|NCT01955083|141613717|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71055070|NCT01955083|141613718|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71055071|NCT01955083|141613719|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher Exact|||||||<0.05
71055072|NCT02472223|141613757|SUPERIORITY||Median Difference (Final Values)|90.0||||0.02|TWO_SIDED|||||p-value is not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||0.02
71055073|NCT01758588|141613777|OTHER||||||||||||||||||A statistical comparison and analysis of the clinical improvement (CI) proportions cannot be made because the sample size (n=5 in treatment arm, n=3 in observation arm) is too small|||
71055074|NCT03185013|141613801|SUPERIORITY|Superiority was concluded if the one-sided p-value was \<0.025 and the corresponding lower bound of the 95% CI exceeded zero (0).|Difference in percentage|11.4||||0.029|TWO_SIDED|95.0|-0.4|21.2|||Miettinen and Nurminen method|||||21.2|-0.4|0.029
71055075|NCT03185013|141613803|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in percentage|12.8|||||TWO_SIDED|95.0|-0.6|24.5||||||||24.5|-0.6|
71055076|NCT03185013|141613804|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in percentage|18.2|||||TWO_SIDED|95.0|5.1|29.4||||||||29.4|5.1|
71055077|NCT03185013|141613805|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in percentage|13.5|||||TWO_SIDED|95.0|1.7|23.5||||||||23.5|1.7|
71055078|NCT03185013|141613806|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in percentage|11.8|||||TWO_SIDED|95.0|1.5|20.3||||||||20.3|1.5|
71055079|NCT03185013|141613807|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in percentage|-1.7|||||TWO_SIDED|95.0|-11.5|10.3||||||||10.3|-11.5|
71055080|NCT03185013|141613808|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in percentage|10.8|||||TWO_SIDED|95.0|-0.5|20.1||||||||20.1|-0.5|
71055081|NCT03185013|141613809|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Location shift|224.0|||||TWO_SIDED|95.0|24.0|224.0||||||Week 15: HPV-16 E7||224.0|24.0|
71055082|NCT03185013|141613809|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Location shift|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Week 36: HPV-16 E7||0.0|0.0|
71055083|NCT03185013|141613809|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Location Shift|2024.0|||||TWO_SIDED|95.0|2000.0|6050.0||||||Week 15: HPV-18 E7||6050.0|2000.0|
71055084|NCT03185013|141613809|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Location Shift|224.0|||||TWO_SIDED|95.0|74.0|674.0||||||Week 36: HPV-18 E7||674.0|74.0|
71055085|NCT03185013|141613810|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Location shift|11.67|||||TWO_SIDED|95.0|8.33|20.0||||||HPV-16 E6: Week 15||20.00|8.33|
71055086|NCT03185013|141613810|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|8.33|||||TWO_SIDED|95.0|3.33|11.67||||||HPV-16 E6: Week 36||11.67|3.33|
71055087|NCT03185013|141613810|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|10.83|||||TWO_SIDED|95.0|5.0|15.0||||||HPV-16 E7: Week 15||15.00|5.00|
71055088|NCT03185013|141613810|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|7.5|||||TWO_SIDED|95.0|1.67|10.0||||||HPV-16 E7: Week 36||10.00|1.67|
71055089|NCT03185013|141613810|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|50.83|||||TWO_SIDED|95.0|31.67|66.67||||||HPV-18 E6: Week 15||66.67|31.67|
71055090|NCT03185013|141613810|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|38.33|||||TWO_SIDED|95.0|18.33|51.67||||||HPV-18 E6: Week 36||51.67|18.33|
71055091|NCT03185013|141613810|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|14.17|||||TWO_SIDED|95.0|6.67|18.33||||||HPV-18 E7: Week 15||18.33|6.67|
71055092|NCT03185013|141613810|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|10.0|||||TWO_SIDED|95.0|5.0|15.0||||||HPV-18 E7: Week 36||15.00|5.00|
71055093|NCT03185013|141613811|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|0.025|||||TWO_SIDED|95.0|0.002|0.046||||||Parameter: CD8+CD137+Perforin+||0.046|0.002|
71055094|NCT03185013|141613811|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|0.011|||||TWO_SIDED|95.0|0.0|0.014||||||Parameter: CD8+CD38+Perforin+||0.014|0.000|
71055095|NCT03185013|141613811|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|0.044|||||TWO_SIDED|95.0|0.017|0.058||||||Parameter: CD8+CD69+Perforin+||0.058|0.017|
71055096|NCT00673387|141613848|SUPERIORITY_OR_OTHER||||||<|0.0001||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion.|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||<0.0001
71055097|NCT00673387|141613848|SUPERIORITY_OR_OTHER|||||||0.0002||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.0002
71106994|NCT04881760|141720472|SUPERIORITY||Risk Difference (RD)|82.0|||<|0.001|TWO_SIDED|95.0|71.0|92.0|||Regression, Logistic|||||92|71|<0.001
71106995|NCT04881760|141720473|SUPERIORITY||LS Mean difference (Final Values)|-6.46|||<|0.001|TWO_SIDED|95.0|-8.36|-4.56|||Mixed Models Analysis|||||-4.56|-8.36|<0.001
71106996|NCT04881760|141720473|SUPERIORITY||LS Mean difference (Final Values)|-11.32|||<|0.001|TWO_SIDED|95.0|-13.34|-9.3|||Mixed Models Analysis|||||-9.30|-13.34|<0.001
71106997|NCT04881760|141720473|SUPERIORITY||LS Mean difference (Final Values)|-13.52|||<|0.001|TWO_SIDED|95.0|-15.99|-11.05|||Mixed Models Analysis|||||-11.05|-15.99|<0.001
71106998|NCT04881760|141720473|SUPERIORITY||LS Mean difference (Final Values)|-16.43|||<|0.001|TWO_SIDED|95.0|-18.41|-14.45|||Mixed Models Analysis|||||-14.45|-18.41|<0.001
71106999|NCT04881760|141720473|SUPERIORITY||LS Mean difference (Final Values)|-18.48|||<|0.001|TWO_SIDED|95.0|-20.93|-16.04|||Mixed Models Analysis|||||-16.04|-20.93|<0.001
71107000|NCT04881760|141720473|SUPERIORITY||LS Mean difference (Final Values)|-17.26|||<|0.001|TWO_SIDED|95.0|-19.11|-15.4|||Mixed Models Analysis|||||-15.40|-19.11|<0.001
71107001|NCT04881760|141720474|SUPERIORITY||LS Mean difference (Final Values)|-7.53|||<|0.001|TWO_SIDED|95.0|-10.18|-4.88|||Mixed Models Analysis|||||-4.88|-10.18|<0.001
70933195|NCT04162210|141367095|OTHER||Stratified Hazard Ratio (HR)|1.03||||0.558|TWO_SIDED|95.0|0.72|1.47|||Log Rank|One-sided p-value from stratified log-rank test were adjusted for previous treatment with anti-CD38, ISS staging and number of prior lines of therapy.|HR was estimated using the Cox Proportional Hazards. HR stratified log-rank test were adjusted for previous treatment with anti-CD38, international staging system (ISS) staging and number of prior lines of therapy.|||1.47|0.72|0.558
70933196|NCT03244800|141367130|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
71021943|NCT00660790|141551812|OTHER|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||The paired student's t-test or the Wilcoxon signed-rank test was used to compare the measurements before and after multifactorial treatment, as appropriate, depending on the distribution of the data.||||0.021
71107002|NCT04881760|141720474|SUPERIORITY||LS Mean difference (Final Values)|-15.48|||<|0.001|TWO_SIDED|95.0|-19.35|-11.6|||Mixed Models Analysis|||||-11.60|-19.35|<0.001
71107003|NCT04881760|141720474|SUPERIORITY||LS Mean difference (Final Values)|-17.29|||<|0.001|TWO_SIDED|95.0|-21.19|-13.39|||Mixed Models Analysis|||||-13.39|-21.19|<0.001
71107004|NCT04881760|141720474|SUPERIORITY||LS Mean difference (Final Values)|-21.69|||<|0.001|TWO_SIDED|95.0|-25.25|-18.12|||Mixed Models Analysis|||||-18.12|-25.25|<0.001
71107005|NCT04881760|141720474|SUPERIORITY||LS Mean difference (Final Values)|-24.04|||<|0.001|TWO_SIDED|95.0|-27.72|-20.36|||Mixed Models Analysis|||||-20.36|-27.72|<0.001
71107006|NCT04881760|141720474|SUPERIORITY||LS Mean difference (Final Values)|-24.34|||<|0.001|TWO_SIDED|95.0|-27.4|-21.27|||Mixed Models Analysis|||||-21.27|-27.40|<0.001
71107007|NCT04881760|141720475|SUPERIORITY||LS Mean difference (Final Values)|-2.15|||<|0.001|TWO_SIDED|95.0|-2.8|-1.5|||Mixed Models Analysis|||||-1.50|-2.80|<0.001
70933197|NCT03244800|141367131|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
70933198|NCT03244800|141367132|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
70933199|NCT03244800|141367133|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
70933200|NCT03244800|141367134|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
70933201|NCT03244800|141367135|SUPERIORITY||Odds Ratio (OR)|10.76||||0.04|TWO_SIDED|90.0|1.61|72.03|||Regression, Logistic|||||72.03|1.61|0.040
71107008|NCT04881760|141720475|SUPERIORITY||LS Mean difference (Final Values)|-3.98|||<|0.001|TWO_SIDED|95.0|-4.66|-3.29|||Mixed Models Analysis|||||-3.29|-4.66|<0.001
71107009|NCT04881760|141720475|SUPERIORITY||LS Mean difference (Final Values)|-4.64|||<|0.001|TWO_SIDED|95.0|-5.46|-3.82|||Mixed Models Analysis|||||-3.82|-5.46|<0.001
71107010|NCT04881760|141720475|SUPERIORITY||LS Mean difference (Final Values)|-5.66|||<|0.001|TWO_SIDED|95.0|-6.34|-4.99|||Mixed Models Analysis|||||-4.99|-6.34|<0.001
71107011|NCT04881760|141720475|SUPERIORITY||LS Mean difference (Final Values)|-6.35|||<|0.001|TWO_SIDED|95.0|-7.17|-5.53|||Mixed Models Analysis|||||-5.53|-7.17|<0.001
71107012|NCT04881760|141720475|SUPERIORITY||LS Mean difference (Final Values)|-5.95|||<|0.001|TWO_SIDED|95.0|-6.59|-5.32|||Mixed Models Analysis|||||-5.32|-6.59|<0.001
71107013|NCT04881760|141720476|SUPERIORITY||LS Mean difference (Final Values)|-2.5|||<|0.001|TWO_SIDED|95.0|-3.42|-1.57|||Mixed Models Analysis|||||-1.57|-3.42|<0.001
71107014|NCT04881760|141720476|SUPERIORITY||LS Mean difference (Final Values)|-5.42|||<|0.001|TWO_SIDED|95.0|-6.81|-4.03|||Mixed Models Analysis|||||-4.03|-6.81|<0.001
71107015|NCT04881760|141720476|SUPERIORITY||LS Mean difference (Final Values)|-5.95|||<|0.001|TWO_SIDED|95.0|-7.23|-4.67|||Mixed Models Analysis|||||-4.67|-7.23|<0.001
71107016|NCT04881760|141720476|SUPERIORITY||LS Mean difference (Final Values)|-7.4|||<|0.001|TWO_SIDED|95.0|-8.62|-6.18|||Mixed Models Analysis|||||-6.18|-8.62|<0.001
71107017|NCT04881760|141720476|SUPERIORITY||LS Mean difference (Final Values)|-8.3|||<|0.001|TWO_SIDED|95.0|-9.55|-7.05|||Mixed Models Analysis|||||-7.05|-9.55|<0.001
71107018|NCT04881760|141720476|SUPERIORITY||LS Mean difference (Final Values)|-8.42|||<|0.001|TWO_SIDED|95.0|-9.49|-7.35|||Mixed Models Analysis|||||-7.35|-9.49|<0.001
71107019|NCT04881760|141720477|SUPERIORITY||LS Mean difference (Final Values)|-2.82||||0.022|TWO_SIDED|95.0|-5.23|-0.41|||Mixed Models Analysis|||||-0.41|-5.23|0.022
71107020|NCT04881760|141720477|SUPERIORITY||LS Mean difference (Final Values)|-7.73|||<|0.001|TWO_SIDED|95.0|-10.32|-5.13|||Mixed Models Analysis|||||-5.13|-10.32|<0.001
71107021|NCT04881760|141720477|SUPERIORITY||LS Mean difference (Final Values)|-9.95|||<|0.001|TWO_SIDED|95.0|-12.47|-7.43|||Mixed Models Analysis|||||-7.43|-12.47|<0.001
71107022|NCT04881760|141720477|SUPERIORITY||LS Mean difference (Final Values)|-11.14|||<|0.001|TWO_SIDED|95.0|-13.72|-8.56|||Mixed Models Analysis|||||-8.56|-13.72|<0.001
71107023|NCT04881760|141720477|SUPERIORITY||LS Mean difference (Final Values)|-12.38|||<|0.001|TWO_SIDED|95.0|-14.87|-9.9|||Mixed Models Analysis|||||-9.90|-14.87|<0.001
71021944|NCT03840811|141551814|OTHER|||||||0.23|||||||Sign test|||To assess whether the fitness of a given mutant is different than that of wild-type, the ratio of colony-forming units of the mutant strain was compared to those of the WT strain at the time of treatment and in the inoculum using a Wilcoxon Signed-Rank Test with a significance level of 0.025. CIs of participants in Mixed FA1090 + FA7537 group were compared to mean = 1.||||0.230
71021945|NCT03840811|141551815|OTHER||Risk Difference (RD)|-0.14||||0.54|TWO_SIDED|95.0|-0.58|0.34||One-sided Fisher's Exact Test with alpha=0.025|Fisher Exact|||||0.34|-0.58|0.54
71021946|NCT01625845|141551823|SUPERIORITY_OR_OTHER|||||||0.474|TWO_SIDED|95.0|||||ANCOVA|||||||.474
71021947|NCT01625845|141551824|SUPERIORITY_OR_OTHER|||||||0.068|TWO_SIDED|95.0|||||ANCOVA|||||||.068
71021948|NCT01625845|141551825|SUPERIORITY_OR_OTHER|||||||0.296|TWO_SIDED|95.0|||||ANCOVA|||||||.296
71021949|NCT01625845|141551826|SUPERIORITY_OR_OTHER|||||||0.203|TWO_SIDED|95.0|||||ANCOVA|||||||.203
71021950|NCT01625845|141551827|SUPERIORITY_OR_OTHER|||||||0.906|TWO_SIDED||||||ANCOVA|||||||.906
71021951|NCT01625845|141551828|SUPERIORITY_OR_OTHER|||||||0.869|TWO_SIDED|95.0|||||ANCOVA|||||||.869
71021952|NCT01625845|141551829|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|95.0|||||ANCOVA|||||||.026
71021953|NCT01294592|141551847|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.8|-1.7||Month 1|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.7|-2.8|<0.001
71021954|NCT01294592|141551847|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.7|-1.5||Month 3|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.5|-2.7|<0.001
71055098|NCT00673387|141613848|SUPERIORITY_OR_OTHER|||||||0.0004||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.0004
71055099|NCT00673387|141613848|SUPERIORITY_OR_OTHER||||||<|0.0001||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||||||<0.0001
71055100|NCT00673387|141613848|SUPERIORITY_OR_OTHER|||||||0.0001||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||||||0.0001
71055101|NCT00673387|141613848|SUPERIORITY_OR_OTHER|||||||0.251||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.2510
71055102|NCT00673387|141613848|SUPERIORITY_OR_OTHER|||||||0.3433||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.3433
71055103|NCT00673387|141613848|SUPERIORITY_OR_OTHER|||||||0.4503||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.4503
71055104|NCT00673387|141613848|SUPERIORITY_OR_OTHER|||||||0.2122||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.2122
71055105|NCT00673387|141613848|SUPERIORITY_OR_OTHER|||||||0.2232||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.2232
71055106|NCT00673387|141613848|SUPERIORITY_OR_OTHER|||||||0.4207||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion.|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.4207
71107024|NCT04881760|141720477|SUPERIORITY||LS Mean difference (Final Values)|-11.73|||<|0.001|TWO_SIDED|95.0|-14.04|-9.43|||Mixed Models Analysis|||||-9.43|-14.04|<0.001
71107025|NCT04881760|141720478|SUPERIORITY||LS Mean difference (Final Values)|-3.84||||0.01|TWO_SIDED|95.0|-6.77|-0.91|||Mixed Models Analysis|||||-0.91|-6.77|0.010
71107026|NCT04881760|141720478|SUPERIORITY||LS Mean difference (Final Values)|-11.94|||<|0.001|TWO_SIDED|95.0|-15.54|-8.33|||Mixed Models Analysis|||||-8.33|-15.54|<0.001
71107027|NCT04881760|141720478|SUPERIORITY||LS Mean difference (Final Values)|-12.22|||<|0.001|TWO_SIDED|95.0|-16.11|-8.33|||Mixed Models Analysis|||||-8.33|-16.11|<0.001
70933202|NCT03542305|141367230|OTHER||Ratio (%) of Adjusted Geometric Means|104.25|||||TWO_SIDED|90.0|79.73|136.31|||ANOVA|The natural log transformed parameter was used.|Normal renal function was the reference group. Mild renal impairment was test group. The estimate was derived from ratio (%) of adjusted geometric means of Test and Reference.|||136.31|79.73|
71107028|NCT04881760|141720478|SUPERIORITY||LS Mean difference (Final Values)|-15.88|||<|0.001|TWO_SIDED|95.0|-19.33|-12.43|||Mixed Models Analysis|||||-12.43|-19.33|<0.001
71107029|NCT04881760|141720478|SUPERIORITY||LS Mean difference (Final Values)|-15.85|||<|0.001|TWO_SIDED|95.0|-19.39|-12.31|||Mixed Models Analysis|||||-12.31|-19.39|<0.001
71107030|NCT04881760|141720478|SUPERIORITY||LS Mean difference (Final Values)|-16.95|||<|0.001|TWO_SIDED|95.0|-20.13|-13.78|||Mixed Models Analysis|||||-13.78|-20.13|<0.001
71107031|NCT01538199|141720491|SUPERIORITY_OR_OTHER|||||||0.04||||||a priori threshold for statistical significance: p≤0.05|t-test, 1 sided|We used a modified intent-to-treat approach with LOCF and unpaired Student's t-test (one-way), comparing the change in total severity score.||||||0.04
71107032|NCT01538199|141720491|SUPERIORITY_OR_OTHER|||||||0.08||||||a priori threshold for statistical significance: p≤0.05|t-test, 2 sided|Modified intent-to-treat approach with lost observation carried forward (LOCF) and a two-tailed t-test to compare the change in total severity score.||||||0.08
71107033|NCT01538199|141720491|SUPERIORITY_OR_OTHER|||||||0.01||||||a priori threshold for statistical significance: p≤0.05|t-test, 1 sided|One-tailed t-test to compare the change in total severity score for treatment completers.||This analysis includes only treatment completers (participants who who were followed for the entire 8-week study period and who received a clinical assessment immediately after).||||0.01
71107034|NCT01538199|141720491|SUPERIORITY_OR_OTHER|||||||0.02||||||a priori threshold for statistical significance: p≤0.05|t-test, 2 sided|Two-tailed t-test to compare the change in total severity score for treatment completers.||This analysis includes only treatment completers (participants who who were followed for the entire 8-week study period and who received a clinical assessment immediately after).||||0.02
71107035|NCT01538199|141720491|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||By means of a paired t-test we tested the significance of the change in the mean HAM-D17 total score (from baseline) to week 8. Although the primary comparison was with the last assessment (week 8). A last observation carried forward (LOCF) was also performed to account for one missing value at week 8.||||0.004
71107036|NCT01538199|141720494|SUPERIORITY_OR_OTHER|||||||0.18||||||a priori threshold for statistical significance: p≤0.05|t-test, 1 sided|Last observation carried forward (LOCF), one tailed t-test to compare change in QIDS score.||||||0.18
71107037|NCT01538199|141720494|SUPERIORITY_OR_OTHER|||||||0.01||||||a priori threshold for statistical significance: p≤0.05|t-test, 1 sided|One-tailed t-test to measure the change in QIDS score for treatment completers.||This analysis includes only treatment completers (participants who who were followed for the entire 8-week study period and who received a clinical assessment immediately after). One treatment completer in Group 1 was excluded because they consistently skipped several answers across self-rated scales for the duration of the study.||||0.01
70933203|NCT03542305|141367230|OTHER||Ratio (%) of Adjusted Geometric Means|118.75|||||TWO_SIDED|90.0|91.43|154.24|||ANOVA|The natural log transformed parameter was used.|Normal renal function was the reference group. Moderate renal impairment was test group. The estimate was derived from ratio (%) of adjusted geometric means of Test and Reference.|||154.24|91.43|
71107038|NCT01538199|141720494|SUPERIORITY_OR_OTHER|||||||0.02||||||a priori threshold for statistical significance: p≤0.05|t-test, 2 sided|Two-tailed t-test measuring change in QIDS score for treatment completers.||This analysis includes only treatment completers (participants who who were followed for the entire 8-week study period and who received a clinical assessment immediately after). One treatment completer in Group 1 was excluded because they consistently skipped several answers across self-rated scales for the duration of the study.||||0.02
71107039|NCT00271544|141720540|SUPERIORITY_OR_OTHER||One sample proportion|0.955||||||95.0|0.92|0.955|||||1-side 95% confidence limit lower bound|||0.955|0.92|
71107040|NCT00271544|141720541|SUPERIORITY_OR_OTHER||One sample proportion|0.96||||||95.0|0.932|0.989||||||||0.989|0.932|
71107041|NCT00271544|141720542|SUPERIORITY_OR_OTHER||One sample mean|1.1|STANDARD_DEVIATION|0.9||||95.0|1.1|1.2|||||1-side 95% confidence limit upper bound|||1.2|1.1|
71107042|NCT00271544|141720543|SUPERIORITY_OR_OTHER||One sample mean|1.9|STANDARD_DEVIATION|2.0||||97.5|1.9|2.2|||||1-sided 97.5% confidence limit upper bound|||2.2|1.9|
71107043|NCT00271544|141720544|SUPERIORITY_OR_OTHER||One sample proportion|0.989||||||95.0|0.974|1.0||||||||1|0.974|
71107044|NCT00271544|141720545|SUPERIORITY_OR_OTHER||One sample proportion|0.973||||||95.0|0.95|0.996||||||||0.996|0.950|
71107045|NCT00271544|141720546|SUPERIORITY_OR_OTHER||One sample proportion|0.973||||||95.0|0.95|0.996||||||||0.996|0.950|
71107046|NCT03358030|141720560|OTHER||||||<|0.05|||||||ANOVA|||Day 12 through Day 260||||<0.05
71107047|NCT03358030|141720560|OTHER||||||<|0.05|||||||ANOVA|||Day 15 through Day 232||||<0.05
71107048|NCT03358030|141720561|OTHER||||||<|0.05|||||||Wilcoxon Rank Sum Test|Wilcoxon Rank Sum Test based on t approximation||Day 15 through Day 176||||< 0.05
71107049|NCT03358030|141720561|OTHER||||||<|0.05|||||||Wilcoxon Rank Sum Test|Wilcoxon Rank Sum Test based on t approximation||Day 12 through Day 176||||< 0.05
71107050|NCT00829244|141720566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.8||0.037|TWO_SIDED|95.0|-3.3|-0.1|||ANOVA|||The null hypothesis was that the difference between the mean number of oocytes \[CONSORT calculator dosing - Standard dosing\] was less than or equal to \[=\<\] (-3). The alternate hypothesis was that the difference was greater than \[\>\] (-3).||-0.1|-3.3|0.037
71107051|NCT00829244|141720567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-511.37|STANDARD_ERROR_OF_MEAN|64.52|<|0.001|TWO_SIDED|95.0|-638.78|-383.96|||ANOVA|||||-383.96|-638.78|<0.001
70933204|NCT03542305|141367230|OTHER||Ratio (%) of Adjusted Geometric Means|141.14|||||TWO_SIDED|90.0|97.82|203.66|||ANOVA|The natural log transformed parameter was used.|Normal renal function was the reference group. Severe renal impairment was test group. The estimate was derived from ratio (%) of adjusted geometric means of Test and Reference.|||203.66|97.82|
71055107|NCT00673387|141613848|SUPERIORITY_OR_OTHER|||||||0.5375||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion.|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%||||0.5375
71055108|NCT00673387|141613848|SUPERIORITY_OR_OTHER|||||||0.6633||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%||||0.6633
71055109|NCT00673387|141613848|SUPERIORITY_OR_OTHER|||||||0.3667||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.3667
71055110|NCT00673387|141613848|SUPERIORITY_OR_OTHER|||||||0.372||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion.|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.3720
71055111|NCT00673387|141613852|SUPERIORITY_OR_OTHER|||||||0.0404|||||||t-test, 2 sided|||Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate||||0.0404
71055112|NCT00673387|141613852|SUPERIORITY_OR_OTHER|||||||0.0265|||||||t-test, 2 sided|||Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate.||||0.0265
71055113|NCT00673387|141613852|SUPERIORITY_OR_OTHER|||||||0.1357|||||||t-test, 2 sided|||Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate.||||0.1357
71055114|NCT00673387|141613852|SUPERIORITY_OR_OTHER|||||||0.0409|||||||t-test, 2 sided|||Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate.||||0.0409
71055115|NCT00673387|141613852|SUPERIORITY_OR_OTHER|||||||0.0082|||||||t-test, 2 sided|||Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate.||||0.0082
71055116|NCT00673387|141613856|SUPERIORITY_OR_OTHER|||||||0.0464|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0464
71055117|NCT00673387|141613856|SUPERIORITY_OR_OTHER|||||||0.0647|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0647
71055118|NCT00673387|141613856|SUPERIORITY_OR_OTHER|||||||0.069|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0690
71107052|NCT00829244|141720568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-45.6|STANDARD_ERROR_OF_MEAN|4.12|<|0.001|TWO_SIDED|95.0|-53.75|-37.46|||ANOVA|||||-37.46|-53.75|<0.001
71107053|NCT00829244|141720569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.933|TWO_SIDED|95.0|-0.4|0.5|||ANOVA|||||0.5|-0.4|0.933
71107054|NCT00829244|141720571|SUPERIORITY_OR_OTHER||Percent difference|3.6|||||TWO_SIDED|95.0|-11.0|18.2||||||||18.2|-11.0|
71107055|NCT00829244|141720573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|6.6||0.926|TWO_SIDED|95.0|-12.3|13.6|||ANOVA|||||13.6|-12.3|0.926
71107056|NCT00829244|141720575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.78||0.235|TWO_SIDED|95.0|-0.61|2.47|||ANOVA|||||2.47|-0.61|0.235
71055119|NCT00673387|141613856|SUPERIORITY_OR_OTHER|||||||0.3717|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.3717
71107057|NCT00829244|141720576|SUPERIORITY_OR_OTHER||Percent difference|0.6|||||TWO_SIDED|95.0|-13.5|14.6||||||||14.6|-13.5|
71055120|NCT00673387|141613856|SUPERIORITY_OR_OTHER|||||||0.0327|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0327
71107058|NCT02297412|141720618|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0186|||||||Wilcoxon (Mann-Whitney)|||||||0.0186
71107059|NCT02297412|141720619|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1146|||||||Wilcoxon (Mann-Whitney)|||||||0.1146
71021955|NCT01294592|141551847|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.1|-0.9||Month 6|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-0.9|-2.1|<0.001
71021956|NCT01294592|141551847|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.2|-1.0||Month 9|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.0|-2.2|<0.001
71021957|NCT01294592|141551847|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.32|<|0.001|TWO_SIDED|95.0|-2.2|-1.0||Month 12|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.0|-2.2|<0.001
71021958|NCT01294592|141551847|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-2.3|-1.0||Month 15|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.0|-2.3|<0.001
71021959|NCT01294592|141551847|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.35|<|0.001|TWO_SIDED|95.0|-2.4|-1.0||Month 18|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.0|-2.4|<0.001
71021960|NCT01294592|141551847|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-2.5|-1.2||Month 21|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.2|-2.5|<0.001
71021961|NCT01294592|141551847|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-2.5|-1.2||Month 24|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.2|-2.5|<0.001
71021962|NCT03549130|141551861|SUPERIORITY||Least Square (LS) mean difference|-0.77||||0.2446|TWO_SIDED|95.0|-2.06|0.53||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep problems.||0.53|-2.06|0.2446
71021963|NCT03549130|141551861|SUPERIORITY||LS mean difference|-1.8||||0.0333|TWO_SIDED|95.0|-3.45|-0.14||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep Time Problems.||-0.14|-3.45|0.0333
71021964|NCT03549130|141551861|SUPERIORITY||LS mean difference|-1.63||||0.0345|TWO_SIDED|95.0|-3.13|-0.12||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Symptoms on Waking in the Morning.||-0.12|-3.13|0.0345
71021965|NCT03549130|141551861|SUPERIORITY||LS mean difference|-0.71||||0.1711|TWO_SIDED|95.0|-1.72|0.31||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Practical Problems.||0.31|-1.72|0.1711
71021966|NCT03549130|141551862|SUPERIORITY||LS mean difference|-0.47||||0.5063|TWO_SIDED|95.0|-1.85|0.92||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep problems.||0.92|-1.85|0.5063
71055121|NCT00673387|141613857|SUPERIORITY_OR_OTHER|||||||0.0049|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0049
71055122|NCT00673387|141613857|SUPERIORITY_OR_OTHER|||||||0.0047|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0047
71055123|NCT00673387|141613857|SUPERIORITY_OR_OTHER|||||||0.0046|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0046
71055124|NCT00673387|141613857|SUPERIORITY_OR_OTHER|||||||0.0257|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0257
71055125|NCT00673387|141613857|SUPERIORITY_OR_OTHER|||||||0.0014|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0014
71055126|NCT00673387|141613858|SUPERIORITY_OR_OTHER|||||||0.0222|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0222
71055127|NCT00673387|141613858|SUPERIORITY_OR_OTHER|||||||0.0128|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0128
71055128|NCT00673387|141613858|SUPERIORITY_OR_OTHER|||||||0.0122|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0122
71055129|NCT00673387|141613858|SUPERIORITY_OR_OTHER|||||||0.0073|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0073
71055130|NCT00673387|141613858|SUPERIORITY_OR_OTHER|||||||0.0034|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0034
71055131|NCT00960115|141613876|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.953||||0.828|TWO_SIDED|95.0|0.614|1.479||This trial was not powered to demonstrate statistical significance of treatment differences with respect to a statistical test, i.e., the p value being lower than a significance level of alpha (α) = 0.05.|Log Rank||Cox proportional hazards regression model|||1.479|0.614|0.828
71055132|NCT04428333|141613880|SUPERIORITY|Other|Hazard Ratio (HR)|2.16||||0.74|TWO_SIDED|95.0|0.2|23.87||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and Human Papilloma Virus (HPV) status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||23.87|0.20|0.740
71055133|NCT04428333|141613881|SUPERIORITY|Other|Hazard Ratio (HR)|2.16||||0.74|TWO_SIDED|95.0|0.2|23.87||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS ≥ 20 vs 1≤ CPS\<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||23.87|0.20|0.740
71055134|NCT04428333|141613882|SUPERIORITY|Other|Hazard Ratio (HR)|0.7||||0.284|TWO_SIDED|95.0|0.2|2.43||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||2.43|0.20|0.284
71055135|NCT04428333|141613883|SUPERIORITY|Other|Hazard Ratio (HR)|0.7||||0.284|TWO_SIDED|95.0|0.2|2.43||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS≥20 vs 1≤CPS\<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||2.43|0.20|0.284
71055136|NCT04428333|141613886|OTHER||Difference in Percentage|-4.8|||||TWO_SIDED|95.0|-20.8|11.3||||||The comparison between treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||11.3|-20.8|
71055137|NCT04428333|141613887|OTHER||Difference in Percentage|-5.1|||||TWO_SIDED|95.0|-21.4|11.3||||||The comparison between treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included PD-L1 expression (CPS≥20 vs 1≤CPS\<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||11.3|-21.4|
71055138|NCT04428333|141613888|OTHER||Difference in Percentage|-4.8|||||TWO_SIDED|95.0|-22.2|13.1||||||The comparison between treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||13.1|-22.2|
71055139|NCT04428333|141613889|OTHER||Difference in Percentage|-5.1|||||TWO_SIDED|95.0|-22.8|13.3||||||The comparison between treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||13.3|-22.8|
71077926|NCT02913105|141664399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.91||||0.008|TWO_SIDED|90.0|0.87|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 28||0.97|0.87|0.0080
71107060|NCT02297412|141720620|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0243|||||||Wilcoxon (Mann-Whitney)|||||||0.0243
71117619|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
71055140|NCT04428333|141613906|SUPERIORITY|Other|Hazard Ratio (HR)|0.85||||0.329|TWO_SIDED|95.0|0.42|1.71||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||1.71|0.42|0.329
71055141|NCT04428333|141613907|SUPERIORITY|Other|Hazard Ratio (HR)|0.82||||0.302|TWO_SIDED|95.0|0.4|1.69||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS≥20 vs 1≤CPS\<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||1.69|0.40|0.302
71055142|NCT04428333|141613908|SUPERIORITY|Other|Hazard Ratio (HR)|0.96||||0.472|TWO_SIDED|95.0|0.44|2.11||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||2.11|0.44|0.472
71055143|NCT04428333|141613909|SUPERIORITY|Other|Hazard Ratio (HR)|0.83||||0.335|TWO_SIDED|95.0|0.36|1.9||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS≥20 vs 1≤CPS\<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||1.90|0.36|0.335
71055144|NCT00319982|141613919|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED|||||Adjusted for age, sex, genotype, family relations, and baseline value. p\<0.05 considered statistically significant.|Generalized estimating equation|Generalized estimating equation approach accounting for an exchangeable correlation structure within families||Change in E' Velocity comparing baseline and final study visits||||0.75
71055145|NCT00319982|141613920|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Fisher Exact|||Adverse Events||||0.99
71055146|NCT00319982|141613921|SUPERIORITY_OR_OTHER||||||>|0.06|TWO_SIDED|||||Adjusted for age, sex, genotype, family relations, and baseline value. p\<0.05 considered statistically significant.|Generalized Estimating Equation|Generalized estimating equation approach accounting for an exchangeable correlation structure within families||||||>0.06
71055147|NCT00319982|141613922|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Adjusted for age, sex, genotype, family relations, and baseline value|Generalized Estimating Equation|Generalized estimating equation approach accounting for an exchangeable correlation structure within families||Change in LV End-Diastolic Diameter z-score from baseline to final visit||||<0.001
71055148|NCT00319982|141613924|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Percentage adherent to study medication||||0.08
71055149|NCT00319982|141613925|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED|||||Adjusted for age, sex, genotype, family relations, and baseline value|Generalized estimating equation|Generalized estimating equation approach accounting for an exchangeable correlation structure within families||||||0.15
71055150|NCT01094886|141613926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|0.5||0.008|TWO_SIDED|95.0|-0.05|0.34|||t-test, 2 sided|||||0.34|-0.05|.008
71055151|NCT01094886|141613927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91|STANDARD_DEVIATION|-1.1||0.111|TWO_SIDED|95.0|-2.048|0.219|||t-test, 2 sided|||||0.219|-2.048|0.111
71055152|NCT01094886|141613928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_DEVIATION|6.977||0.87|TWO_SIDED|95.0|-2.77|2.35|||t-test, 2 sided|||||2.35|-2.77|0.87
71055153|NCT01094886|141613929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.13|STANDARD_DEVIATION|36.316|<|0.001|TWO_SIDED|95.0|-48.01|-22.26|||t-test, 2 sided|||||-22.26|-48.01|<0.001
71055154|NCT03480386|141613932|SUPERIORITY|||||||0.0788|||||||t-test, 2 sided|||Daily Light Physical Activity||||0.0788
71055155|NCT03480386|141613932|SUPERIORITY|||||||0.0742|||||||t-test, 2 sided|||Daily Moderate Physical Activity||||0.0742
71055156|NCT03480386|141613933|SUPERIORITY|||||||0.0113|||||||t-test, 2 sided|||||||0.0113
71055157|NCT03480386|141613934|SUPERIORITY|||||||0.0021|||||||t-test, 2 sided|||||||0.0021
71055158|NCT03480386|141613935|SUPERIORITY|||||||0.2216|||||||t-test, 2 sided|||||||0.2216
71055159|NCT03480386|141613936|SUPERIORITY|||||||0.4762|||||||t-test, 2 sided|||||||0.4762
71055160|NCT03480386|141613937|SUPERIORITY|||||||0.0068|||||||t-test, 2 sided|||||||0.0068
71055161|NCT03480386|141613938|SUPERIORITY|||||||0.1548|||||||t-test, 2 sided|||||||0.1548
71055162|NCT02629354|141613971|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|113.77|||||TWO_SIDED|90.0|98.99|130.75|||ANOVA||Analysis of variance (ANOVA) with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% confidence interval (CI) was provided.||130.75|98.99|
70851407|NCT02191865|141190610|SUPERIORITY_OR_OTHER||Ratio of geometric means|761.01|STANDARD_DEVIATION|69.1|||TWO_SIDED|90.0|439.01|1319.18|||ANOVA|Fixed effect: 'hepatic status'; indicated whether a subject with hepatic impairment or a healthy subject , Random effect: 'matched pair'.|Ratio of Child Pugh B (Test): Healthy Child Pugh B (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of Cmax was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.||1319.18|439.01|
71021967|NCT03549130|141551862|SUPERIORITY||LS mean difference|-0.97||||0.2496|TWO_SIDED|95.0|-2.64|0.69||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep time problems.||0.69|-2.64|0.2496
71021968|NCT03549130|141551862|SUPERIORITY||LS mean difference|-0.71||||0.3325|TWO_SIDED|95.0|-2.16|0.74||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for symptoms on waking in the morning.||0.74|-2.16|0.3325
70851408|NCT02191865|141190611|SUPERIORITY_OR_OTHER||ratio of the geometric means|216.79|STANDARD_DEVIATION|75.0|||TWO_SIDED|90.0|120.37|390.45|||ANOVA|Fixed effect: 'hepatic status'; indicated whether a subject with hepatic impairment or a healthy subject , Random effect: 'matched pair'.|Ratio of Child Pugh A (Test): Healthy Child Pugh A (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of AUC (0-tz) was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.||390.45|120.37|
71055163|NCT02629354|141613972|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|110.16|||||TWO_SIDED|90.0|96.32|125.97|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||125.97|96.32|
71055164|NCT02629354|141613973|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|112.69|||||TWO_SIDED|90.0|98.49|128.94|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||128.94|98.49|
71055165|NCT02629354|141613974|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|97.36|||||TWO_SIDED|90.0|94.61|100.19|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||100.19|94.61|
71055166|NCT02629354|141613975|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|96.47|||||TWO_SIDED|90.0|93.74|99.28|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||99.28|93.74|
71055167|NCT02629354|141613976|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|97.55|||||TWO_SIDED|90.0|92.57|102.8|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||102.80|92.57|
71055168|NCT02629354|141613977|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|97.57|||||TWO_SIDED|90.0|94.5|100.73|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||100.73|94.50|
71055169|NCT02629354|141613978|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|97.21|||||TWO_SIDED|90.0|92.22|102.46|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||102.46|92.22|
71055170|NCT02629354|141613979|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|96.83|||||TWO_SIDED|90.0|93.75|100.01|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||100.01|93.75|
71055171|NCT04308226|141614027|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71055172|NCT04308226|141614029|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
71055173|NCT03610516|141614031|OTHER|A repeated measures mixed model was fitted with factors for treatment group (CFZ533 or placebo) and visit.|Ratio of geometric means CFZ533/placebo|0.579||||0.0788|TWO_SIDED|95.0|0.267|1.256||one-sided p-value|Repeated measures Mixed Model|||||1.256|0.267|0.0788
71021969|NCT03549130|141551862|SUPERIORITY||LS mean difference|-0.81||||0.1088|TWO_SIDED|95.0|-1.81|0.18||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for practical problems.||0.18|-1.81|0.1088
71055174|NCT01328379|141614042|SUPERIORITY_OR_OTHER||least squares mean|0.054|STANDARD_ERROR_OF_MEAN|0.0724||0.457|TWO_SIDED|95.0|-0.088|0.196||To demonstrate study sensitivity with respect to efficacy and maintain an overall alpha level ≤ 0.05, a stepwise procedure was performed.|ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in walking speed at Approximately CmaxSS at Visit 3||0.196|-0.088|0.457
71107061|NCT02031302|141720621|OTHER|One-sided Clopper-Pearson 98.699% upper bound|||||<|0.0001||||||The proportion of patients who experience an event through 30 days post-procedure out of the patients who have either had an event within 30 days post-procedure or who were event-free with last follow-up at least 23 days post-procedure.|Chi-squared|||Note: the 95% CI is from Clopper-Pearson Exact Method. The analysis was only done for the Lotus valve arm as the Lotus with Depth Guard arm has not sufficient power for this statistical analysis.|One-sided Clopper-Pearson 98.699% upper bound: 4.11% Performance goal is 14%|||<.0001
71107062|NCT03950856|141720641|OTHER||Difference in Percentage|1.3||||0.538|TWO_SIDED|95.0|-3.3|4.8|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Injection site erythema: V114 Combined Lots - Prevnar 13™||4.8|-3.3|0.538
71107063|NCT03950856|141720641|OTHER||Difference in Percentage|14.6|||<|0.001|TWO_SIDED|95.0|7.9|21.4|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Injection site pain: V114 Combined Lots - Prevnar 13™||21.4|7.9|<0.001
71107064|NCT03950856|141720641|OTHER||Difference in Percentage|1.0||||0.686|TWO_SIDED|95.0|-4.3|5.3|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Injection site swelling: V114 Combined Lots - Prevnar 13™||5.3|-4.3|0.686
71021970|NCT03549130|141551863|SUPERIORITY||LS mean difference|-0.25||||0.2513|TWO_SIDED|95.0|-0.68|0.18||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for feel tired and unrefreshed.||0.18|-0.68|0.2513
71107065|NCT03950856|141720643|OTHER||Difference in Percentage|2.0||||0.272|TWO_SIDED|95.0|-1.9|4.7|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Arthralgia: V114 Combined Lots - Prevnar 13™||4.7|-1.9|0.272
71021971|NCT03549130|141551863|SUPERIORITY||LS mean difference|-0.37||||0.0743|TWO_SIDED|95.0|-0.78|0.04||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for nasal congestion or stuffy nose.||0.04|-0.78|0.0743
71055175|NCT01328379|141614042|SUPERIORITY_OR_OTHER||least squares mean|0.118|STANDARD_ERROR_OF_MEAN|0.0732||0.107|TWO_SIDED|95.0|-0.026|0.262|||ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in walking speed at Approximately CmaxSS at Visit 3||0.262|-0.026|0.107
71107066|NCT03950856|141720643|OTHER||Difference in Percentage|-0.7||||0.812|TWO_SIDED|95.0|-6.7|4.5|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Fatigue: V114 Combined Lots - Prevnar 13™||4.5|-6.7|0.812
70933205|NCT03542305|141367231|OTHER||Ratio (%) of Adjusted Geometric Means|100.53|||||TWO_SIDED|90.0|66.48|152.02|||ANOVA|The natural log transformed parameter was used.|Normal renal function was the reference group. Mild renal impairment was test group. The estimate was derived from ratio (%) of adjusted geometric means of Test and Reference.|||152.02|66.48|
71055176|NCT01328379|141614042|SUPERIORITY_OR_OTHER||least squares mean|0.064|STANDARD_ERROR_OF_MEAN|0.0724||0.375|TWO_SIDED|95.0|-0.078|0.207|||ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in walking speed at Approximately CmaxSS at Visit 3||0.207|-0.078|0.375
71055177|NCT01328379|141614043|SUPERIORITY_OR_OTHER||Least Squares Mean|-0.014|STANDARD_ERROR_OF_MEAN|0.0666||0.832|TWO_SIDED|95.0|-0.145|0.117||To demonstrate study sensitivity with respect to efficacy and maintain an overall alpha level ≤ 0.05, a stepwise procedure was performed.|ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in walking speed at Approximately CminSS at Visit 3||0.117|-0.145|0.832
71107067|NCT03950856|141720643|OTHER||Difference in Percentage|0.2||||0.947|TWO_SIDED|95.0|-5.6|5.0|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Headache: V114 Combined Lots - Prevnar 13™||5.0|-5.6|0.947
71107068|NCT03950856|141720643|OTHER||Difference in Percentage|5.2||||0.091|TWO_SIDED|95.0|-0.9|10.4|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Myalgia: V114 Combined Lots - Prevnar 13™||10.4|-0.9|0.091
71107069|NCT03950856|141720645|OTHER||Miettinen & Nurminen|0.0|||||TWO_SIDED|95.0|-1.6|0.2|||||V114 Combined Lots minus Prevnar 13™|V114 Combined Lots - Prevnar 13™||0.2|-1.6|
71107070|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.99|||<|0.001|TWO_SIDED|95.0|0.83|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 1: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.18|0.83|<0.001
71021972|NCT03549130|141551863|SUPERIORITY||LS mean difference|-0.55||||0.0158|TWO_SIDED|95.0|-0.99|-0.1||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for congestion in sinuses.||-0.10|-0.99|0.0158
71021973|NCT03549130|141551863|SUPERIORITY||LS mean difference|-0.47||||0.0489|TWO_SIDED|95.0|-0.94|0.0||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for time to clear nighttime drainage after waking up.||0.00|-0.94|0.0489
71021974|NCT03549130|141551864|SUPERIORITY||LS mean difference|-0.19||||0.3034|TWO_SIDED|95.0|-0.57|0.18||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for feel tired and unrefreshed.||0.18|-0.57|0.3034
71021975|NCT03549130|141551864|SUPERIORITY||LS mean difference|-0.15||||0.4891|TWO_SIDED|95.0|-0.57|0.27||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for nasal congestion or stuffy nose.||0.27|-0.57|0.4891
71021976|NCT03549130|141551864|SUPERIORITY||LS mean difference|-0.01||||0.9498|TWO_SIDED|95.0|-0.43|0.4||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for congestion in sinuses.||0.40|-0.43|0.9498
71021977|NCT03549130|141551864|SUPERIORITY||LS mean difference|-0.36||||0.1235|TWO_SIDED|95.0|-0.83|0.1||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for time to clear nighttime drainage after waking up.||0.10|-0.83|0.1235
71021978|NCT03549130|141551865|SUPERIORITY|||||||0.8498||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep problems.||||0.8498
71021979|NCT03549130|141551865|SUPERIORITY|||||||0.4652||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep problems.||||0.4652
71021980|NCT03549130|141551865|SUPERIORITY|||||||0.439||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep time problems.||||0.4390
71021981|NCT03549130|141551865|SUPERIORITY|||||||0.2997||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep time problems.||||0.2997
71107071|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.87|1.24||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 1: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.24|0.87|<0.001
71107072|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.88|1.25||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 1: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.25|0.88|<0.001
71107073|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.85|||<|0.001|TWO_SIDED|95.0|0.75|0.97||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 3: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|0.97|0.75|<0.001
71107074|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.92|||<|0.001|TWO_SIDED|95.0|0.81|1.05||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 3: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.05|0.81|<0.001
71107075|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.95|1.23||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 3: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.23|0.95|<0.001
71021982|NCT03549130|141551865|SUPERIORITY|||||||0.1116||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in symptoms on waking in AM.||||0.1116
71021983|NCT03549130|141551865|SUPERIORITY|||||||0.5101||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in symptoms on waking in AM.||||0.5101
71021984|NCT03549130|141551865|SUPERIORITY|||||||0.474||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in practical problems.||||0.4740
71021985|NCT03549130|141551865|SUPERIORITY|||||||0.2787||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in practical problems.||||0.2787
71021986|NCT03549130|141551866|SUPERIORITY|||||||0.5958||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep problems.||||0.5958
71021987|NCT03549130|141551866|SUPERIORITY|||||||0.7296||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep problems.||||0.7296
71021988|NCT03549130|141551866|SUPERIORITY|||||||0.7171||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep time problems.||||0.7171
71021989|NCT03549130|141551866|SUPERIORITY|||||||0.403||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep time problems.||||0.4030
71021990|NCT03549130|141551866|SUPERIORITY|||||||0.4741||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in symptoms on waking in AM.||||0.4741
71021991|NCT03549130|141551866|SUPERIORITY|||||||0.5591||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in symptoms on waking in AM.||||0.5591
71021992|NCT03549130|141551866|SUPERIORITY|||||||0.8285||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in practical problems.||||0.8285
71021993|NCT03549130|141551866|SUPERIORITY|||||||0.3487||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in practical problems.||||0.3487
71107076|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.82|||<|0.001|TWO_SIDED|95.0|0.7|0.97||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 4: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|0.97|0.70|<0.001
71107077|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.85|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 4: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.18|0.85|<0.001
71021994|NCT00623623|141551873|OTHER||Relative risk|0.86||||0.195|TWO_SIDED|95.0|0.68|1.08|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.08|0.68|0.195
71021995|NCT00623623|141551874|OTHER||Relative risk|1.03||||0.904|TWO_SIDED|95.0|0.68|1.55|||modified Poisson regression|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.55|0.68|0.904
71021996|NCT00623623|141551875|OTHER||Relative risk|0.97||||0.905|TWO_SIDED|95.0|0.6|1.58|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.58|0.60|0.905
71021997|NCT00623623|141551876|SUPERIORITY_OR_OTHER||Relative risk|0.73||||0.12|TWO_SIDED|95.0|0.49|1.08|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.08|0.49|0.120
71021998|NCT00623623|141551877|OTHER||Relative risk|0.79||||0.17|TWO_SIDED|95.0|0.57|1.11|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.11|0.57|0.170
71021999|NCT00623623|141551878|OTHER||Relative risk|1.1||||0.758|TWO_SIDED|95.0|0.61|1.97|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.97|0.61|0.758
71022000|NCT00623623|141551879|OTHER||Relative risk|1.1||||0.663|TWO_SIDED|95.0|0.73|1.66|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.66|0.73|0.663
71022001|NCT00623623|141551880|OTHER||Relative risk|1.72||||0.148|TWO_SIDED|95.0|0.82|3.6|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||3.60|0.82|0.148
71022002|NCT00623623|141551881|OTHER||Relative risk|0.5||||0.572|TWO_SIDED|95.0|0.05|5.52|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||5.52|0.05|0.572
71022003|NCT00623623|141551882|OTHER||Relative risk|0.81||||0.207|TWO_SIDED|95.0|0.58|1.13|||modified Poission Regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.13|0.58|0.207
71022004|NCT00623623|141551883|OTHER||Relative risk|0.81||||0.1|TWO_SIDED|95.0|0.63|1.04|||modified Poission Regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.04|0.63|0.100
71055178|NCT01328379|141614043|SUPERIORITY_OR_OTHER||Least Squares Mean|0.093|STANDARD_ERROR_OF_MEAN|0.0674||0.167|TWO_SIDED|95.0|-0.039|0.226|||ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in walking speed at Approximately CminSS at Visit 3||0.226|-0.039|0.167
71055179|NCT01328379|141614043|SUPERIORITY_OR_OTHER||Least Squares Mean|0.107|STANDARD_ERROR_OF_MEAN|0.0666||0.108|TWO_SIDED|95.0|-0.024|0.238|||ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in walking speed at Approximately CminSS at Visit 3||0.238|-0.024|0.108
71055180|NCT01328379|141614044|SUPERIORITY_OR_OTHER||Lease Squares Mean|-0.4|STANDARD_ERROR_OF_MEAN|2.367||0.866|TWO_SIDED|95.0|-5.05|4.25|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in MSWS-12 at visit 3||4.25|-5.05|0.866
71055181|NCT01328379|141614044|SUPERIORITY_OR_OTHER||Least Squares Mean|-2.56|STANDARD_ERROR_OF_MEAN|2.393||0.286|TWO_SIDED|95.0|-7.26|2.15|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in MSWS-12 at visit 3||2.15|-7.26|0.286
71055182|NCT01328379|141614044|SUPERIORITY_OR_OTHER||Least Squares Mean|-2.16|STANDARD_ERROR_OF_MEAN|2.366||0.362|TWO_SIDED|95.0|-6.81|2.49|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in MSWS-12 at visit 3||2.49|-6.81|0.362
71055183|NCT01328379|141614045|SUPERIORITY_OR_OTHER||Least Squares Mean|0.84|STANDARD_ERROR_OF_MEAN|2.237||0.708|TWO_SIDED|95.0|-3.56|5.24|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in MSWS-12 at visit 2||5.24|-3.56|0.708
71055184|NCT01328379|141614045|SUPERIORITY_OR_OTHER||Least Squares Mean|-0.38|STANDARD_ERROR_OF_MEAN|2.258||0.868|TWO_SIDED|95.0|-4.81|4.06|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in MSWS-12 at visit 2||4.06|-4.81|0.868
71055185|NCT01328379|141614045|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.21|STANDARD_ERROR_OF_MEAN|2.236||0.588|TWO_SIDED|95.0|-5.61|3.18|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in MSWS-12 at visit 2||3.18|-5.61|0.588
71055186|NCT01328379|141614046|SUPERIORITY_OR_OTHER||Least Squares Mean|35.4|STANDARD_ERROR_OF_MEAN|34.57||0.308|TWO_SIDED|95.0|-33.0|103.7|||ANOVA|Change from Baseline in Six-Minute Walk Distance as dependent variable and Baseline Six-Minute Walk Distance and Treatment as independent variables.||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in Six-Minute Walk Distance at visit 2||103.7|-33.0|0.308
71055187|NCT01328379|141614046|SUPERIORITY_OR_OTHER||Least Squares Mean|87.1|STANDARD_ERROR_OF_MEAN|34.9||0.014|TWO_SIDED|95.0|18.2|156.1|||ANOVA|Change from Baseline in Six-Minute Walk Distance as dependent variable and Baseline Six-Minute Walk Distance and Treatment as independent variables.||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in Six-Minute Walk Distance at visit 2||156.1|18.2|0.014
71055188|NCT01328379|141614046|SUPERIORITY_OR_OTHER||Least Squares Mean|51.7|STANDARD_ERROR_OF_MEAN|34.21||0.133|TWO_SIDED|95.0|-15.9|119.3|||ANOVA|Change from Baseline in Six-Minute Walk Distance as dependent variable and Baseline Six-Minute Walk Distance and Treatment as independent variables.||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in Six-Minute Walk Distance at visit 2||119.3|-15.9|0.133
71055189|NCT01328379|141614047|SUPERIORITY_OR_OTHER||Least Squares Mean|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.32|TWO_SIDED|95.0|0.0|0.1|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in Average EQ-5D score at Visit 3||0.1|-0.0|0.320
71107078|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.21|||<|0.001|TWO_SIDED|95.0|1.03|1.43||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 4: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.43|1.03|<0.001
71107079|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.84|||<|0.001|TWO_SIDED|95.0|0.7|1.02||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 5: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.02|0.70|<0.001
71107080|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.83|1.2||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 5: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.20|0.83|<0.001
71022005|NCT00623623|141551884|OTHER||Relative Risk|0.91||||0.511|TWO_SIDED|95.0|0.67|1.22|||modified Poission Regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.22|0.67|0.511
70933206|NCT03542305|141367231|OTHER||Slope|88.87|||||TWO_SIDED|90.0|64.18|123.06|||ANOVA|The natural log transformed parameter was used.|Normal renal function was the reference group. Moderate renal impairment was test group. The estimate was derived from ratio (%) of adjusted geometric means of Test and Reference.|||123.06|64.18|
70933207|NCT03542305|141367231|OTHER||Ratio (%) of Adjusted Geometric Means|92.32|||||TWO_SIDED|90.0|56.58|150.63|||ANOVA|The natural log transformed parameter was used.|Normal renal function was the reference group. Severe renal impairment was test group. The estimate was derived from ratio (%) of adjusted geometric means of Test and Reference.|||150.63|56.58|
70933208|NCT00857766|141367242|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.42||||0.065||95.0|-0.88|0.03|||ANCOVA||LS mean difference is calculated as FSC 250/50 minus Placebo and is adjusted for treatment, investigator, sex, smoking status, age, body mass index (BMI), waist circumference, treatment by sex interaction, age by BMI interaction, and baseline value.|||0.03|-0.88|0.065
70933209|NCT00857766|141367243|SUPERIORITY_OR_OTHER||Least squares analysis|-0.6|STANDARD_ERROR_OF_MEAN|0.86||0.469||95.0|-2.3|1.1|||ANCOVA|||||1.1|-2.3|0.469
71022006|NCT00623623|141551885|OTHER||Relative Risk|1.75||||0.369|TWO_SIDED|95.0|0.52|5.97|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||5.97|0.52|0.369
71022007|NCT00623623|141551886|OTHER||Relative Risk|4.99||||0.168|TWO_SIDED|95.0|0.51|49.08|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||49.08|0.51|0.168
71022008|NCT00623623|141551887|OTHER||Relative Risk|8.02||||0.049|TWO_SIDED|95.0|1.0|63.97|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||63.97|1.00|0.049
71022009|NCT00623623|141551888|OTHER||Relative Risk|4.51||||0.054|TWO_SIDED|95.0|0.98|20.82|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||20.82|0.98|0.054
71022010|NCT00623623|141551889|OTHER||Relative Risk|2.0||||0.324|TWO_SIDED|95.0|0.5|7.99|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||7.99|0.50|0.324
71022011|NCT00623623|141551890|OTHER||Relative Risk|3.01||||0.032|TWO_SIDED|95.0|1.1|8.24|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||8.24|1.10|0.032
71022012|NCT00623623|141551891|OTHER||Relative Risk|1.36||||0.111|TWO_SIDED|95.0|0.93|1.97|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.97|0.93|0.111
71022013|NCT00623623|141551892|OTHER||Relative Risk|1.08||||0.397|TWO_SIDED|95.0|0.91|1.28|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.28|0.91|0.397
71055190|NCT01328379|141614047|SUPERIORITY_OR_OTHER||Least Squares Mean|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.734|TWO_SIDED|95.0|-0.1|0.0|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in Average EQ-5D score at Visit 3||0.0|-0.1|0.734
71055191|NCT01328379|141614047|SUPERIORITY_OR_OTHER||Least Squares Mean|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.185|TWO_SIDED|95.0|-0.1|0.0|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in Average EQ-5D score at Visit 3||0.0|-0.1|0.185
71055192|NCT01328379|141614048|SUPERIORITY_OR_OTHER||Least Squares Mean|-3.4|STANDARD_ERROR_OF_MEAN|1.79||0.055|TWO_SIDED|95.0|-7.0|0.1|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in EQ-5D VAS score at Visit 3||0.1|-7.0|0.055
71055193|NCT01328379|141614048|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.2|STANDARD_ERROR_OF_MEAN|1.83||0.53|TWO_SIDED|95.0|-4.7|2.4|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in EQ-5D VAS score at Visit 3||2.4|-4.7|0.530
71055194|NCT01328379|141614048|SUPERIORITY_OR_OTHER||Least Squares Mean|2.3|STANDARD_ERROR_OF_MEAN|1.8||0.203|TWO_SIDED|95.0|-1.2|5.8|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in EQ-5D VAS score at Visit 3||5.8|-1.2|0.203
70933210|NCT00857766|141367244|SUPERIORITY_OR_OTHER||Least squares analysis|127.0|STANDARD_ERROR_OF_MEAN|35.5|<|0.001||95.0|57.0|197.0|||ANCOVA|||||197|57|<0.001
70933211|NCT01367236|141367288|SUPERIORITY|||||||0.68|||||||Regression, Linear|||24 weeks||||0.68
71022014|NCT00623623|141551893|OTHER||Relative Risk|1.13||||0.107|TWO_SIDED|95.0|0.97|1.31|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.31|0.97|0.107
71022015|NCT00623623|141551894|OTHER||Relative Risk|0.84||||0.471|TWO_SIDED|95.0|0.53|1.34|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.34|0.53|0.471
71055195|NCT00660907|141614049|NON_INFERIORITY_OR_EQUIVALENCE|non-inferior margin delta = 0.35|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0569|<|0.0001|TWO_SIDED|95.0|-0.11|0.11||Significant at alpha=0.025 (1-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|ANCOVA|with treatment group as effect and baseline value as covariate||The null hypothesis is given as H0: mean(treat) minus mean(reference) \>= delta versus the alternative HA: mean(treat) minus mean(reference) \< delta (with alpha = 0.025, one-sided)||0.11|-0.11|<0.0001
71022016|NCT00623623|141551895|SUPERIORITY||Relative Risk|0.35||||0.003|TWO_SIDED|95.0|0.17|0.71|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||0.71|0.17|0.003
71022017|NCT00623623|141551896|OTHER||Relative risk|1.17||||0.451|TWO_SIDED|95.0|0.78|1.73|||modified Poisson regression model|modified Poisson regression model with robust error variance||||1.73|0.78|0.451
71022018|NCT00623623|141551897|OTHER||Relative Risk|0.87||||0.22|TWO_SIDED|95.0|0.69|1.09|||modified Poisson regression model|modified Poisson regression model with robust error variance||||1.09|0.69|0.220
71022019|NCT01078623|141551898|SUPERIORITY_OR_OTHER||Least squares mean difference|0.221|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.174|0.268|||Mixed Models Analysis|Treatment and period as fixed effects, subject as random effect, and baseline values at each period as a covariate||||0.268|0.174|<0.0001
71022020|NCT01078623|141551898|SUPERIORITY_OR_OTHER||Least squares mean difference|0.234|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.186|0.281|||Mixed Models Analysis|Treatment and period as fixed effects, subject as random effect, and baseline values at each period as a covariate||||0.281|0.186|<0.0001
71022021|NCT02186808|141551901|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71022022|NCT00950833|141551922|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 1.|GMC ratio for anti-1|6.17|||||TWO_SIDED|95.0|5.03|7.58|||ANOVA|||To demonstrate the immunological memory induced for anti-pneumococcal serotype 1 following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||7.58|5.03|
70933212|NCT01367236|141367288|SUPERIORITY|||||||0.43|||||||Regression, Linear|||48 weeks||||0.43
70933213|NCT01367236|141367289|SUPERIORITY|||||||0.0009|||||||Regression, Linear|||||||0.0009
70933214|NCT02350634|141367298|OTHER||Correlation coefficient|0.429|||<|0.001|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||<0.001
70933215|NCT02350634|141367299|OTHER||Correlation coefficient|0.681|||<|0.001|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||<0.001
70933216|NCT02350634|141367300|OTHER||Correlation coefficient|0.644||||0.00278|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||0.00278
71022023|NCT00950833|141551922|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled SynflorixI+II Group over Synflorix Group) was higher than 1 for pneumococcal serotype 4.|GMC ratio for anti-4|2.86|||||TWO_SIDED|95.0|2.38|3.45|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 4 induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||3.45|2.38|
71022024|NCT00950833|141551922|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 5.|GMC ratio for anti-5|13.47|||||TWO_SIDED|95.0|10.96|16.55|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 5 induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||16.55|10.96|
70933217|NCT02350634|141367301|OTHER||Correlation coefficient|0.437||||0.12|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||0.12
71055196|NCT00660907|141614050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.65|STANDARD_ERROR_OF_MEAN|0.2483|<|0.0001|TWO_SIDED|95.0|-5.14|-4.17||Significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group as effect and baseline value as covariate||H0: mean(treat) minus mean(reference) = 0 versus the alternative HA: mean(treat) minus mean(reference) =/= 0||-4.17|-5.14|<0.0001
71107081|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.18|||<|0.001|TWO_SIDED|95.0|0.98|1.42||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 5: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.42|0.98|<0.001
71107082|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.82|1.12||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 6A: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.12|0.82|<0.001
71107083|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.95|||<|0.001|TWO_SIDED|95.0|0.82|1.12||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 6A: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.12|0.82|<0.001
71107084|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.99|||<|0.001|TWO_SIDED|95.0|0.85|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 6A: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.16|0.85|<0.001
71107085|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.82|1.12||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 6B: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.12|0.82|<0.001
71107086|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.86|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 6B: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.18|0.86|<0.001
71107087|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.9|1.23||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 6B: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.23|0.90|<0.001
71107088|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.82|||<|0.001|TWO_SIDED|95.0|0.72|0.93||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 7F: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|0.93|0.72|<0.001
71107089|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.89|||<|0.001|TWO_SIDED|95.0|0.79|1.01||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 7F: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.01|0.79|<0.001
71107090|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.96|1.24||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 7F: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.24|0.96|<0.001
71107091|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.88|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 9V: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.16|0.88|<0.001
71107092|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.98|||<|0.001|TWO_SIDED|95.0|0.85|1.12||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 9V: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.12|0.85|<0.001
71107093|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.84|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 9V: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.11|0.84|<0.001
71107094|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.81|1.1||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 14: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.10|0.81|<0.001
70933218|NCT02350634|141367302|OTHER||Correlation coefficient|0.324||||0.0712|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||0.0712
71055197|NCT00660907|141614051|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-37.2|STANDARD_ERROR_OF_MEAN|2.578|<|0.0001|TWO_SIDED|95.0|-42.3|-32.2||Significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(reference) = 0 versus the alternative HA: proportion(treat) minus proportion(reference) =/= 0||-32.2|-42.3|<0.0001
71055198|NCT00660907|141614052|SUPERIORITY_OR_OTHER||Risk Difference (RD)|30.8|STANDARD_ERROR_OF_MEAN|2.48|<|0.0001|TWO_SIDED|95.0|26.0|35.7||Significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(reference) = 0 versus the alternative HA: proportion(treat) minus proportion(reference) =/= 0||35.7|26.0|<0.0001
71055199|NCT00618332|141614072|SUPERIORITY_OR_OTHER|||||||0.372||95.0|||||t-test, 2 sided|||||||0.372
71055200|NCT00618332|141614073|SUPERIORITY_OR_OTHER|||||||0.775||95.0|||||t-test, 2 sided|||||||0.775
71055201|NCT00618332|141614074|SUPERIORITY_OR_OTHER|||||||0.737||95.0|||||t-test, 2 sided|||||||0.737
71055202|NCT00618332|141614075|SUPERIORITY_OR_OTHER|||||||0.117||95.0|||||t-test, 2 sided|||||||0.117
71055203|NCT00618332|141614076|SUPERIORITY_OR_OTHER|||||||0.676||95.0|||||t-test, 2 sided|||||||0.676
71055204|NCT00618332|141614077|SUPERIORITY_OR_OTHER|||||||0.795||95.0|||||t-test, 2 sided|||||||0.795
71055205|NCT00618332|141614078|SUPERIORITY_OR_OTHER|||||||0.638||95.0|||||t-test, 2 sided|||||||0.638
71055206|NCT00618332|141614079|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||t-test, 2 sided|||||||0.800
71055207|NCT00618332|141614080|SUPERIORITY_OR_OTHER|||||||0.968||95.0|||||t-test, 2 sided|||||||0.968
71055208|NCT05773794|141614091|SUPERIORITY|||||||0.968|||||||t-test, 2 sided|||||||0.968
71055209|NCT05773794|141614091|SUPERIORITY|||||||0.366|||||||t-test, 2 sided|||||||0.366
71055210|NCT05773794|141614091|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71055211|NCT05773794|141614092|SUPERIORITY|||||||0.016|||||||t-test, 2 sided|||||||0.016
71055212|NCT05773794|141614092|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
71055213|NCT05773794|141614092|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||||||0.59
71055214|NCT05773794|141614093|SUPERIORITY|||||||0.0196|||||||t-test, 2 sided|||||||0.0196
70933219|NCT02350634|141367303|OTHER||Correlation coefficient|0.564||||0.0958|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||0.0958
70933220|NCT02350634|141367304|OTHER||Correlation coefficient|-0.189||||0.558|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||0.558
70933221|NCT04241848|141367310|SUPERIORITY||||||=|0.007|||||||ANOVA|||Within-group comparison of Five Times Sit to Stand Test (5xSTS), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.007
70933222|NCT04241848|141367310|SUPERIORITY||||||=|0.24|||||||ANOVA|||Within-group comparison of Five Times Sit to Stand Test (5xSTS), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.240
70933223|NCT04241848|141367310|SUPERIORITY||||||=|0.04|||||||t-test, 2 sided|||Within-group comparison of Five Times Sit to Stand Test (5xSTS), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||=0.04
71022025|NCT00950833|141551922|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 6B.|GMC ratio for anti-6B|28.81|||||TWO_SIDED|95.0|22.54|36.81|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 6B induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||36.81|22.54|
71055215|NCT05773794|141614093|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71055216|NCT05773794|141614093|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71055217|NCT02932306|141614125|SUPERIORITY||||||<|0.001||||||Threshold for significance at 0.05.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) with factors of treatment group and analysis center and the respective baseline lesion count as a covariate.||||<0.001
71055218|NCT02932306|141614126|SUPERIORITY||||||<|0.001||||||Threshold for significance at 0.05.|ANCOVA|||Analysis was performed using ANCOVA with factors of treatment group and analysis center and the respective baseline lesion count as a covariate.||||<0.001
70933224|NCT04241848|141367313|SUPERIORITY|||||||0.129|||||||ANOVA|||Within-group comparison of Six Minute Walk Test (6MWT), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.129
70933225|NCT04241848|141367313|SUPERIORITY|||||||0.25|||||||ANOVA|||Within-group comparison of Six Minute Walk Test (6MWT), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.250
70933226|NCT04241848|141367313|SUPERIORITY||||||=|0.073|||||||t-test, 2 sided|||Within-group comparison of Six Minute Walk Test (6MWT), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||=0.073
70933227|NCT04241848|141367314|SUPERIORITY||||||=|0.091|||||||ANOVA|||Within-group comparison of Ten Meter Walk Test (10MWT), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.091
71055219|NCT02932306|141614127|SUPERIORITY||||||<|0.001||||||Threshold for significance at 0.05.|Regression, Logistic|||Analysis was performed using a logistic regression test (using Firth's Penalized Likelihood) with factors of treatment group and analysis center.||||<0.001
71055220|NCT00843479|141614157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
70933228|NCT04241848|141367314|SUPERIORITY|||||||0.296|||||||ANOVA|||Within-group comparison of Ten Meter Walk Test (10MWT), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.296
70933229|NCT04241848|141367314|SUPERIORITY|||||||0.427|||||||t-test, 2 sided|||Within-group comparison of Ten Meter Walk Test (10MWT), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||0.427
70933230|NCT04241848|141367315|SUPERIORITY|||||||0.063|||||||ANOVA|||Within-group comparison of Timed Up and Go (TUG) Test, from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.063
70933231|NCT04241848|141367315|SUPERIORITY|||||||0.447|||||||ANOVA|||Within-group comparison of Timed Up and Go (TUG) Test, from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.447
70933232|NCT04241848|141367315|SUPERIORITY|||||||0.096|||||||t-test, 2 sided|||Within-group comparison of Timed Up and Go (TUG) Test, from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||0.096
70933233|NCT04241848|141367316|SUPERIORITY|||||||0.035|||||||ANOVA|||Within-group comparison of Step Length of Paretic (Pa) Lower Extremities (LE), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.035
70933234|NCT04241848|141367316|SUPERIORITY||||||=|0.677|||||||ANOVA|||Within-group comparison of Step Length of Paretic (Pa) Lower Extremities (LE), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.677
70933235|NCT04241848|141367316|SUPERIORITY||||||=|0.022|||||||t-test, 2 sided|||Within-group comparison of Step Length of Paretic (Pa) Lower Extremities (LE), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||=0.022
70933236|NCT04241848|141367317|SUPERIORITY||||||=|0.098|||||||ANOVA|||Within-group comparison of Step lengths of the non-paretic (NP) Lower Extremities (LE), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.098
71055221|NCT00843479|141614158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25||||0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.001
71055222|NCT00843479|141614159|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.01
71055223|NCT00843479|141614160|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||||||>0.05
71055224|NCT00843479|141614161|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||||||>0.05
71055225|NCT00843479|141614162|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||||||>0.05
71055226|NCT01386983|141614163|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|3.406||||0.0128|TWO_SIDED|95.0|1.297|8.941|||Regression, Cox|||||8.941|1.297|0.0128
71022026|NCT00950833|141551922|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 7F.|GMC ratio for anti-7F|4.75|||||TWO_SIDED|95.0|3.9|5.78|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 7F induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||5.78|3.9|
71022027|NCT00950833|141551922|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 9V.|GMC ratio for anti-9V|14.1|||||TWO_SIDED|95.0|11.21|17.75|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 9V induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||17.75|11.21|
71055227|NCT01386983|141614164|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Generalized linear model|Gamma distribution with log-link function was used.||||||0.0002
71055228|NCT03207243|141614184|OTHER||Median Rate Ratio|0.82|||||TWO_SIDED|95.0|0.66|0.99|||||Median rate ratio (Placebo - GSK3772847) and its 95% Credible Interval has been presented|||0.99|0.66|
71055229|NCT03207243|141614189|OTHER||Median Rate Ratio|0.71|||||TWO_SIDED|95.0|0.44|1.01|||||Median rate ratio (Placebo - GSK3772847) and its 95% Credible Interval has been presented|||1.01|0.44|
71055230|NCT03207243|141614190|OTHER|||||||0.044|||||||Log Rank|||||||0.044
71055231|NCT03207243|141614234|OTHER||Percent change|-93.4|||<|0.001|TWO_SIDED|95.0|-94.9|-91.7||Week 4|mixed model repeated measures analysis|||||-91.7|-94.9|<0.001
71055232|NCT03207243|141614234|OTHER||Percent change|-92.9|||<|0.001|TWO_SIDED|95.0|-94.8|-90.3||Week 8|mixed model repeated measures analysis|||||-90.3|-94.8|<0.001
71055233|NCT03207243|141614234|OTHER||Percent change|-93.2|||<|0.001|TWO_SIDED|95.0|-95.4|-90.0||Week 12|mixed model repeated measures analysis|||||-90.0|-95.4|<0.001
71055234|NCT03207243|141614234|OTHER||Percent change|-93.3|||<|0.001|TWO_SIDED|95.0|-95.3|-90.4||Week 16|mixed model repeated measures analysis|||||-90.4|-95.3|<0.001
71055235|NCT03207243|141614235|OTHER||Percent change|2300.4|||<|0.001|TWO_SIDED|95.0|1833.9|2879.3||Week 4|mixed model repeated measures analysis|||||2879.3|1833.9|<0.001
71055236|NCT03207243|141614235|OTHER||Percent change|2507.7|||<|0.001|TWO_SIDED|95.0|1924.2|3259.4||Week 8|mixed model repeated measures analysis|||||3259.4|1924.2|<0.001
71055237|NCT03207243|141614235|OTHER||Percent change|2162.2|||<|0.001|TWO_SIDED|95.0|1489.1|3120.3||Week 12|mixed model repeated measures analysis|||||3120.3|1489.1|<0.001
71055238|NCT03207243|141614235|OTHER||Percent change|2663.0|||<|0.001|TWO_SIDED|95.0|1994.6|3544.8||Week 16|mixed model repeated measures analysis|||||3544.8|1994.6|<0.001
71055239|NCT04623086|141614240|OTHER|Comparison of two groups|Mean Difference (Net)|8.1||||0.14|TWO_SIDED||||||t-test, 2 sided|||For our power calculations, we assumed the true change in TIR to be 0% for the bridging group and 15% for the direct-conversion group, and we assumed a common standard deviation of 15% (meaning the distributions of change in TIR are separated by 1 standard-deviation unit), and thereby obtained that 20 patients in each group would provide 87% power to observe a statistically significant (at the two-sided level of .05) difference in mean change of TIR.||||0.14
71055240|NCT04623086|141614241|OTHER|Comparison of two groups|Mean Difference (Net)|4.1||||0.11|TWO_SIDED||||||t-test, 2 sided|||||||0.11
71055241|NCT04623086|141614242|OTHER|Comparison of two groups|Mean Difference (Net)|12.1||||0.29|TWO_SIDED||||||t-test, 2 sided|||||||0.29
71055242|NCT04623086|141614243|OTHER|Comparison of two groups|Mean Difference (Net)|-11.9||||0.015|TWO_SIDED||||||t-test, 2 sided|||||||0.015
71055243|NCT04623086|141614244|OTHER||Mean Difference (Net)|0.3||||0.88|TWO_SIDED||||||t-test, 2 sided|||||||0.88
71055244|NCT04623086|141614245|OTHER|Comparison of two groups|Mean Difference (Net)|2.6||||0.031|TWO_SIDED||||||t-test, 2 sided|||||||0.031
71055245|NCT04623086|141614246|OTHER|Comparison of two groups|Mean Difference (Net)|1.1||||0.27|TWO_SIDED||||||t-test, 2 sided|||||||0.27
71055246|NCT04623086|141614247|OTHER|Comparison of two groups|Mean Difference (Net)|0.0|||>|0.99|TWO_SIDED||||||t-test, 2 sided|||||||>0.99
71055247|NCT00715624|141614248|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.096||0.0002|TWO_SIDED|95.0|-0.55|-0.174||Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0, \>=8.0%), metformin use (yes, no), country as fixed effects, baseline HbA1c as covariate.|ANCOVA|To control type I error, a step-down procedure described by Hochberg and Tomhane was applied.||To detect a difference of 0.5% (or 0.4%) in change from baseline to Week 24 in HbA1c between lixisenatide and placebo, 300 patients in lixisenatide arm and 150 in placebo arm would provide a power of 96% (or 86%) assuming common standard deviation of 1.3% with a 2-sided test at 5% significance level.||-0.174|-0.550|0.0002
71055248|NCT03421730|141614295|OTHER||Geometric mean ratio (%)|8.69|||||TWO_SIDED||||||||A: n=6; D: n=5||The intra-subject coefficient of variation was 25.33%.|||
71055249|NCT03421730|141614295|OTHER||Geometric mean ratio (%)|28.18|||||TWO_SIDED||||||||B: n=6, D: n=5||The intra-subject coefficient of variation was 25.33%.|||
71055250|NCT03421730|141614295|OTHER||Geometric mean ratio (%)|59.51|||||TWO_SIDED||||||||C: n=6, D: n=5||The intra-subject coefficient of variation was 25.33%.|||
71055251|NCT03421730|141614296|OTHER||Geometric mean ratio (%)|13.35|||||TWO_SIDED||||||||A: n=4, D: n=4||The intra-subject coefficient of variation was 22.05%.|||
71055252|NCT03421730|141614296|OTHER||Geometric mean ratio (%)|35.97|||||TWO_SIDED||||||||B: n=4, D: n=4||The intra-subject coefficient of variation was 22.05%|||
71055253|NCT03421730|141614296|OTHER||Geometric mean ratio (%)|76.98|||||TWO_SIDED||||||||C: n=4, D: n=4||The intra-subject coefficient of variation was 22.05%|||
71055254|NCT03421730|141614297|OTHER||Geometric mean ratio (%)|9.55|||||TWO_SIDED||||||||A: n=6, D: n=5||The intra-subject coefficient of variation was 33.04%.|||
71055255|NCT03421730|141614297|OTHER||Geometric mean ratio (%)|32.42|||||TWO_SIDED||||||||B: n=6, D: n=5||The intra-subject coefficient of variation was 33.04%.|||
71055256|NCT03421730|141614297|OTHER||Geometric mean ratio (%)|59.75|||||TWO_SIDED||||||||C: n=6, D: n=5||The intra-subject coefficient of variation was 33.04%.|||
70933237|NCT04241848|141367317|SUPERIORITY|||||||0.666|||||||ANOVA|||Within-group comparison of Step lengths of the non-paretic (NP) Lower Extremities (LE), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.666
71055257|NCT00118534|141614315|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.09||||0.007|TWO_SIDED|95.0|1.22|3.59|||Regression, Logistic|||The target sample size (n=1400)was designed to have 90% power to detect the difference between 6% and 11% prolonged abstinence rates in SCC and IC, respectively, using a 2-sided .05 level Chi-square test. Final enrollment was 943. The recruitment period was not extended because the achieved sample size provided 78% power to detect the hypothesized prolonged abstinence rates, and the study continued to the end of planned follow-up.||3.59|1.22|0.007
71055258|NCT00118534|141614316|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.43|||<|0.001|TWO_SIDED|95.0|1.58|3.74|||Regression, Logistic|||||3.74|1.58|<0.001
71055259|NCT01590797|141614361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.001|TWO_SIDED|95.0|-0.5|-0.19|||Robust Regression|Robust regression using M-estimation with terms for treatment and the metformin stratum and type of insulin, and baseline A1C (%) as a covariate.||||-0.19|-0.50|<0.001
71055260|NCT01590797|141614362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.002|TWO_SIDED|95.0|-0.61|-0.14|||Robust Regression|Robust regression using M-estimation with terms for treatment and type of insulin, and baseline A1C (%) as a covariate.||||-0.14|-0.61|0.002
71055261|NCT01590797|141614363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.5|||<|0.001|TWO_SIDED|95.0|-38.4|-14.7|||ANCOVA|ANCOVA model with terms for treatment and the metformin stratum and type of insulin, and baseline 2-hr Post- Meal Glucose (mg/dL) as a covariate.||||-14.7|-38.4|<0.001
71055262|NCT02687217|141614421|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
71055263|NCT02687217|141614422|SUPERIORITY_OR_OTHER|||||||0.5|||||||Chi-squared|||||||0.5
71055264|NCT02687217|141614423|SUPERIORITY_OR_OTHER|||||||0.5|||||||Chi-squared|||||||0.5
71055265|NCT03898908|141614443|SUPERIORITY|||||||0.015||||||pValues below 0.05 are considered statistically significant|Wilcoxon (Mann-Whitney)|||Comparison between baseline and Week 8||||0.015
71055266|NCT03898908|141614444|SUPERIORITY|||||||0.754||||||pValues below 0.05 are considered statistically significant|Wilcoxon (Mann-Whitney)|||Comparison between baseline and W24||||0.754
71055267|NCT02639052|141614446|SUPERIORITY_OR_OTHER|||||||0.9704||||||Significance defined a priori as p\<0.05. P-values not adjusted for multiple comparisons.|ANOVA with Repeated Measures|||Baseline assessment of itch VAS after itch induction but prior to Botox or saline application. Analyzed using ANOVA with repeated measures to compare main effects of treatment (Botox vs saline) and time, and interaction effect between treatment and time.||||0.9704
71055268|NCT02639052|141614447|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Statistical significance defined a priori as p\<0.05. P-values have not been adjusted for multiple comparisons.|ANOVA with Repeated Measures|||1 week (Visit 2) was the first assessment of itch VAS after itch induction after Botox or saline application. Analyzed using ANOVA with repeated measures to compare main effects of treatment (Botox vs saline) and time, and interaction effect between treatment and time.||||<0.0001
71055269|NCT02639052|141614448|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Statistically significant difference in mean itch VAS between the two treatments (Botox mean=2.45 versus saline mean=3.20, p\<0.0001). Statistical significance defined a priori as p\<0.05. P-values have not been adjusted for multiple comparisons.|ANOVA with Repeated Measures|||1 month (Visit 3) was the second assessment of itch VAS after itch induction after Botox or saline application. Analyzed using ANOVA with repeated measures to compare main effects of treatment (Botox vs saline) and time, and interaction effect between treatment and time.||||<0.0001
71055270|NCT02639052|141614449|SUPERIORITY_OR_OTHER|||||||0.0004||||||Statistical significance defined a priori as p\<0.05. P-values have not been adjusted for multiple comparisons.|ANOVA with Repeated Measures|Analyzed using ANOVA with repeated measures to compare treatment (Botox vs saline), time, and interaction effect between treatment \& time||3 months (Visit 4) was the third assessment of itch VAS after itch induction after Botox or saline application. Analyzed using ANOVA with repeated measures to compare main effects of treatment (Botox vs saline) and time, and interaction effect between treatment and time.||||0.0004
71055271|NCT02639052|141614450|SUPERIORITY_OR_OTHER|||||||0.1306||||||Statistical significance defined a priori as p\<0.05.|ANOVA with Repeated Measures|||Analyzed using ANOVA with repeated measures to compare main effects of treatment (Botox vs saline) and visit, and interaction effect between treatment and visit.||||0.1306
71055272|NCT02730351|141614451|OTHER||Mean Difference (Final Values)|-1.69||||0.109|TWO_SIDED|95.0|-3.76|0.39||Mixed model repeated measures analysis adjusted for fixed effects of treatment, sex, age, treatment period, smoking history, period Baseline FEV1 and the mean of the two period Baseline FEV1 values. Subject is fitted as a random effect.|Mixed Models Analysis|||||0.39|-3.76|0.109
71055273|NCT02730351|141614452|OTHER||Mean Difference (Final Values)|-2.15||||0.051|TWO_SIDED|95.0|-4.31|0.01||Mixed model repeated measures analysis adjusted for fixed effects of treatment, sex, age, treatment period, smoking history, period Baseline FEV1 and the mean of the two period Baseline FEV1 values. Subject is fitted as a random effect.|Mixed Models Analysis|||||0.01|-4.31|0.051
71055274|NCT02730351|141614453|OTHER||Odds Ratio (OR)|1.34||||0.266|TWO_SIDED|95.0|0.8|2.26||Repeated measures logistic regression model with parameters estimated using the Generalized Estimating Equation method. Covariates of treatment, sex, age, treatment period, and period baseline FEV1 were included.|Regression, Logistic||12 hrs: modeling the odds of having FEV1 \>/=95% of pre exercise FEV1 at each of the two time points.|||2.26|0.80|0.266
71055275|NCT02730351|141614453|OTHER||Odds Ratio (OR)|1.37||||0.322|TWO_SIDED|95.0|0.73|2.58||Repeated measures logistic regression model with parameters estimated using the Generalized Estimating Equation method|Regression, Logistic||23 hrs: modeling the odds of having FEV1 \>/=95% of pre exercise FEV1 at each of the two time points.|||2.58|0.73|0.322
70933238|NCT04241848|141367317|SUPERIORITY||||||=|0.007|||||||t-test, 2 sided|||Within-group comparison of Step lengths of the non-paretic (NP) Lower Extremities (LE), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||=0.007
70933239|NCT04241848|141367318|SUPERIORITY||||||=|0.001|||||||ANOVA|||Within-group comparison of the Stair Climb Power Test (SCPT), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.001
71022028|NCT00950833|141551922|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 14.|GMC ratio for anti-14|22.92|||||TWO_SIDED|95.0|17.51|30.0|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 14 induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||30|17.51|
71055276|NCT02730351|141614454|OTHER||Mean Difference (Final Values)|-0.65||||0.342|TWO_SIDED|95.0|-2.01|0.71||Mixed model repeated measures analysis adjusted for fixed effects of treatment, sex, age, treatment period, smoking history, period Baseline FEV1 and the mean of the two period Baseline FEV1 values. Subject is fitted as a random effect.|Mixed Models Analysis||12 hrs post-dose|||0.71|-2.01|0.342
71055277|NCT02730351|141614454|OTHER||Mean Difference (Final Values)|-1.75||||0.041|TWO_SIDED|95.0|-3.42|-0.07||Mixed model repeated measures analysis adjusted for fixed effects of treatment, sex, age, treatment period, smoking history, period Baseline FEV1 and the mean of the two period Baseline FEV1 values.|Mixed Models Analysis||23 hrs post-dose|||-0.07|-3.42|0.041
70933240|NCT04241848|141367318|SUPERIORITY||||||=|0.009|||||||ANOVA|||Within-group comparison of the Stair Climb Power Test (SCPT), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.009
71055278|NCT00838435|141614455|OTHER|Coefficient estimates from a random coefficient model and associated p-values.|Slope|-0.5768|||||TWO_SIDED|95.0|-1.6004|0.4468|||||The slope shown above is based on a 2-year window.|A random coefficient model was used to calculate the slope (per year) of FSIQ over the entire study period. Factors in the model included visit and testing sequence, with change in FSIQ score as the dependent variable. Random terms include both intercept and visit. The treatment was considered successful if the lower 95% confidence limit of the mean change excluded a decline of greater than 5 points over a 2-year window.||0.4468|-1.6004|
71055279|NCT04853992|141614520|SUPERIORITY||Mean Difference (Net)|-0.58|STANDARD_ERROR_OF_MEAN|0.5||0.277|TWO_SIDED|95.0|-1.69|0.53|||Mixed Models Analysis|||The primary endpoint, change from baseline in post-provocation Urticaria Activity Score (UASprovo) to the end of the treatment period, was compared between treatments with the null hypothesis that they are equal against the alternative that they are different. The primary efficacy endpoint was analysed using a linear mixed model, containing treatment, period and carryover effects, the factor site and additionally the value of UASprovo at baseline as a covariate.||0.53|-1.69|0.277
71055280|NCT03582826|141614525|SUPERIORITY|Paired Wilcoxon Signed-Rank Tests|Median Difference (Final Values)|79.0||||0.02|TWO_SIDED|95.0|26.0|163.0||Original p-value for dermatological bacteria was 6e-05. It was adjusted first by applying centered log-ratio (CLR) transformation approach then by false discovery rate (FDR) correction for multiple comparisons by using Benjamini-Hochberg Procedure.|Wilcoxon (Mann-Whitney)|||||163|26|0.02
71055281|NCT02105974|141614563|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.034||||0.001|TWO_SIDED|95.0|0.014|0.055|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)||||0.055|0.014|0.001
71055282|NCT02105974|141614564|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.62||||0.084|TWO_SIDED|95.0|-0.35|5.59|||ANCOVA|||||5.59|-0.35|0.084
71055283|NCT02105974|141614565|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.43|0.78||Nominal p-value|Regression, Cox|||||0.78|0.43|<0.001
71055284|NCT02203331|141614578|SUPERIORITY_OR_OTHER_LEGACY||Emax|0.1483|STANDARD_ERROR_OF_MEAN|0.2925||0.3875|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.3875
71055285|NCT02203331|141614578|SUPERIORITY_OR_OTHER_LEGACY||Linear|0.2484|STANDARD_ERROR_OF_MEAN|0.2975||0.2676|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.2676
71055286|NCT02203331|141614578|SUPERIORITY_OR_OTHER_LEGACY||Sigmoidal Emax 1|0.1995|STANDARD_ERROR_OF_MEAN|0.2922||0.3211|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.3211
71055287|NCT02203331|141614578|SUPERIORITY_OR_OTHER_LEGACY||Sigmoidal Emax 2|0.3467|STANDARD_ERROR_OF_MEAN|0.2994||0.1721|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.1721
71055288|NCT02203331|141614579|SUPERIORITY_OR_OTHER_LEGACY||Emax|0.2736|STANDARD_ERROR_OF_MEAN|0.2878||0.231|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.231
71055289|NCT02203331|141614579|SUPERIORITY_OR_OTHER_LEGACY||Linear|0.3234|STANDARD_ERROR_OF_MEAN|0.2927||0.1865|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.1865
71055290|NCT02203331|141614579|SUPERIORITY_OR_OTHER_LEGACY||Sigmoidal Emax 1|0.3081|STANDARD_ERROR_OF_MEAN|0.2875||0.1955|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.1955
71055291|NCT02203331|141614579|SUPERIORITY_OR_OTHER_LEGACY||Sigmoidal Emax 2|0.3781|STANDARD_ERROR_OF_MEAN|0.2944||0.1416|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.1416
71055292|NCT02203331|141614580|SUPERIORITY_OR_OTHER_LEGACY||Emax|0.0081|STANDARD_ERROR_OF_MEAN|0.2832||0.5794|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.5794
71055293|NCT02203331|141614580|SUPERIORITY_OR_OTHER_LEGACY||Linear|0.1148|STANDARD_ERROR_OF_MEAN|0.288||0.4301|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.4301
71055294|NCT02203331|141614580|SUPERIORITY_OR_OTHER_LEGACY||Sigmoidal Emax 1|0.0401|STANDARD_ERROR_OF_MEAN|0.2829||0.5337|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.5337
71055295|NCT02203331|141614580|SUPERIORITY_OR_OTHER_LEGACY||Sigmoidal Emax 2|0.1835|STANDARD_ERROR_OF_MEAN|0.2899||0.3396|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.3396
71107095|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.15|||<|0.001|TWO_SIDED|95.0|0.99|1.34||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 14: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.34|0.99|<0.001
71107096|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.22|||<|0.001|TWO_SIDED|95.0|1.05|1.43||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 14: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.43|1.05|<0.001
71107097|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.1|||<|0.001|TWO_SIDED|95.0|0.96|1.26||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 18C: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.26|0.96|<0.001
71107098|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.15|||<|0.001|TWO_SIDED|95.0|1.0|1.31||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 18C: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.31|1.00|<0.001
71022029|NCT00950833|141551922|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 18C.|GMC ratio for anti-18C|10.01|||||TWO_SIDED|95.0|7.95|12.61|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 18C induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||12.61|7.95|
71107099|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.91|1.19||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 18C: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.19|0.91|<0.001
71107100|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.9|||<|0.001|TWO_SIDED|95.0|0.79|1.02||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 19A: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.02|0.79|<0.001
71022030|NCT00950833|141551922|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 19F.|GMC ratio for anti-19F|9.25|||||TWO_SIDED|95.0|7.29|11.74|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 19F induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||11.74|7.29|
71022031|NCT00950833|141551922|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 23F.|GMC ratio for anti-23F|36.52|||||TWO_SIDED|95.0|27.59|48.34|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 23F induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||48.34|27.59|
71107101|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.85|1.1||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 19A: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.10|0.85|<0.001
71022032|NCT04132232|141551949|SUPERIORITY|||||||0.06|||||||Chi-squared|||||||0.06
71022033|NCT00368537|141551950|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|0.0||||||95.0|-8.7|8.6|||||Confidence interval calculated using asymptotic method corrected for continuity. Difference= Tigecycline minus Ampicillin-Sulbactam or Amoxicillin-Clavulanate.|||8.6|-8.7|
71022034|NCT00368537|141551951|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|2.2||||||95.0|-9.6|14.0|||||Confidence interval calculated using asymptotic method corrected for continuity. Difference= Tigecycline minus Ampicillin-Sulbactam or Amoxicillin-Clavulanate.|||14.0|-9.6|
71022035|NCT00368537|141551952|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|2.4||||||95.0|-9.6|14.4|||||Confidence interval calculated using asymptotic method corrected for continuity. Difference= Tigecycline minus Ampicillin-Sulbactam or Amoxicillin-Clavulanate.|Group comparison of eradication + presumed eradication||14.4|-9.6|
71107102|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.95|1.22||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 19A: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.22|0.95|<0.001
71107103|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.92|||<|0.001|TWO_SIDED|95.0|0.81|1.05||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 19F: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.05|0.81|<0.001
71055296|NCT02091466|141614585|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|||Analysis of covariance for repeated measures (ANCOVA), adjusted for baseline values, compared tympanic temperatures between the groups. Statistical significance was established at p \< 0.05, and the statistical analysis was performed using SPSS (Statistical Package for the Social Sciences) software version 20.||||<0.05
71055297|NCT01056289|141614605|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: absolute difference between the 2 discontinuation regimens in DESS total scores was \>2.5. Alternative hypothesis: absolute difference was ≤2.5; tested by calculating 95% 2-sided confidence intervals (CIs) on the mean difference between the 2 regimens. If absolute values of both confidence limits were ≤2.5, then the regimens were declared equivalent.|Mean Difference (Final Values)|1.16|||||TWO_SIDED|95.0|-0.51|2.83|||ANCOVA|||Difference: Placebo versus DVS SR 50 mg||2.83|-0.51|
70933241|NCT04241848|141367318|SUPERIORITY|||||||0.018|||||||t-test, 2 sided|||Within-group comparison of the Stair Climb Power Test (SCPT), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||0.018
71055298|NCT01056289|141614605|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: absolute difference between the 2 discontinuation regimens in DESS total scores was \>2.5. Alternative hypothesis: absolute difference was ≤2.5; tested by calculating 95% 2-sided confidence intervals (CIs) on the mean difference between the 2 regimens. If absolute values of both confidence limits were ≤2.5, then the regimens were declared equivalent.|Mean Difference (Final Values)|0.66|||||TWO_SIDED|95.0|-1.03|2.35|||ANCOVA|||Difference: DVS SR 25 mg versus DVS SR 50 mg||2.35|-1.03|
71107104|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.82|1.07||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 19F: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.07|0.82|<0.001
70933242|NCT05325294|141367348|NON_INFERIORITY|The overall mean change in HbA1c from baseline to end of 3-month study period. The mean change will be estimated and compared to a threshold of -0.38% with a margin of 0.4%.|Mean difference from baseline to exit|-0.1||||0.133|TWO_SIDED|95.0|-0.2|0.1|||t-test, 1 sided||This is one arm study, the differences of HbA1c from baseline to exit were summarized for this endpoint|||0.1|-0.2|0.133
71022036|NCT00368537|141551954|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.2||||0.444||95.0|-4.4|2.0|||Fisher Exact|2-sided||Intensive care unit||2.0|-4.4|0.444
71022037|NCT01368276|141551969|SUPERIORITY_OR_OTHER||Treatment Difference|-42.9||||0.2645|TWO_SIDED|||||Descriptive|Fisher Exact||Talimogene laherparepvec - GM-CSF|||||0.2645
71022038|NCT01368276|141551970|SUPERIORITY_OR_OTHER||Treatment Difference|-1.2||||1|TWO_SIDED|95.0|-57.3|54.9||Descriptive|Fisher Exact||Talimogene laherparepvec - GM-CSF|||54.9|-57.3|1.0000
71022039|NCT01427920|141551971|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for subject-driven vs. investigator driven titration would be concluded if the upper bound of the two-sided 95% CI was below or equal to 0.4%.|Estimated treatment difference, Mean|0.25||||||95.0|0.04|0.46|||Regression, Linear|Model includes treatment, strata and region as factors and relevant baseline HbA1c as covariate.||FAS||0.46|0.04|
71055299|NCT01056289|141614605|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: absolute difference between the 2 discontinuation regimens in DESS total scores was \>2.5. Alternative hypothesis: absolute difference was ≤2.5; tested by calculating 95% 2-sided confidence intervals (CIs) on the mean difference between the 2 regimens. If absolute values of both confidence limits were ≤2.5, then the regimens were declared equivalent.|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-0.88|1.89|||ANCOVA|||Difference: Placebo versus DVS SR 25 mg||1.89|-0.88|
71107105|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.89|1.15||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 19F: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.15|0.89|<0.001
70933243|NCT05325294|141367348|NON_INFERIORITY|The overall mean change in HbA1c from baseline to end of 3-month study period. The mean change will be estimated and compared to a threshold of -0.5% with a margin of 0.4%.|Mean difference from baseline to exit|-0.4|||<|0.001|TWO_SIDED|95.0|-0.6|-0.3|||Wilcoxon (Mann-Whitney)||This is one arm study, the differences of HbA1c from baseline to exit were summarized for this endpoint|||-0.3|-0.6|<0.001
70933244|NCT05325294|141367349|NON_INFERIORITY|The mean % of time in range (TIR 70-180 mg/dL) will be estimated and compared to a threshold of 65.3% with a margin of -7.5% and a significance level of 0.025 (one-sided).|Mean of Final Value|68.6|||<|0.001|TWO_SIDED|95.0|66.6|70.7|||t-test, 1 sided||This is one arm study, the Percent of Time in Range (TIR70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||70.7|66.6|<0.001
70933245|NCT05325294|141367349|NON_INFERIORITY|The mean % of time in range (TIR 70-180 mg/dL) will be estimated and compared to a threshold of 73.7% with a margin of -7.5% and a significance level of 0.025 (one-sided).|Mean of Final Value|77.6|||<|0.001|TWO_SIDED|95.0|75.7|79.4|||t-test, 1 sided||This is one arm study, the Percent of Time in Range (TIR70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||79.4|75.7|<0.001
70933246|NCT05325294|141367350|NON_INFERIORITY|The mean % of time in hypoglycemia (\< 54 mg/dL) will be estimated and compared to a threshold of 0.71% with a margin of 2% and a significance level of 0.025 (one-sided).|Mean of Final Value|0.4|||<|0.001|TWO_SIDED|95.0|0.3|0.5|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Hypoglycemia (\< 54 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||0.5|0.3|<0.001
70933247|NCT05325294|141367350|NON_INFERIORITY|The mean % of time in hypoglycemia (\< 54 mg/dL) will be estimated and compared to a threshold of 0.86% with a margin of 2% and a significance level of 0.025 (one-sided).|Mean of Final Value|0.2|||<|0.001|TWO_SIDED|95.0|0.2|0.3|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Hypoglycemia (\< 54 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||0.3|0.2|<0.001
70933248|NCT05325294|141367351|SUPERIORITY|The mean % of time in range (TIR 70-180 mg/dL) will be estimated and compared to a threshold of 65.3% and a significance level of 0.025 (one-sided).|Mean of Final Value|68.6|||<|0.001|TWO_SIDED|95.0|66.6|70.7|||t-test, 1 sided||This is one arm study, the Percent of Time in Range (TIR70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||70.7|66.6|<0.001
71055300|NCT01917916|141614609|OTHER||Slope|2.4386|STANDARD_ERROR_OF_MEAN|0.3417|||TWO_SIDED|95.0|1.7504|3.1267|||||Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is actually standard error of slope.|Dose proportionality was explored using the power model. Dose proportionality of BI 655064 was to be assessed based on the exposure parameter Cmax, determined for the 4 subcutaneous dose levels. This analysis is for the overall population.||3.1267|1.7504|
71107106|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.92|||<|0.001|TWO_SIDED|95.0|0.77|1.1||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 23F: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.10|0.77|<0.001
71107107|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.87|1.24||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 23F: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.24|0.87|<0.001
70933249|NCT05325294|141367351|SUPERIORITY|The mean % of time in range (TIR 70-180 mg/dL) will be estimated and compared to a threshold of 73.7% and a significance level of 0.025 (one-sided).|Mean of Final Value|77.6|||<|0.001|TWO_SIDED|95.0|75.7|79.4|||t-test, 1 sided||This is one arm study, the Percent of Time in Range (TIR70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||79.4|75.7|<0.001
70933250|NCT00705406|141367443|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.927||||0.222|TWO_SIDED|95.0|0.723|1.188|||Wilcoxon-Gehan test statistic|P-value is from a Wilcoxon-Gehan test statistic controlling for smoking status and hemisphere of enrollment.|Hazard Ratio and corresponding 95% CI are based the Cox Regression Model including parameters for treatment, controlling for smoking status and hemisphere of enrollment.|||1.188|0.723|0.222
70933251|NCT00705406|141367444|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||van Elteren test|P-value for comparisons at all time points. P-value was based on the van Elteren test controlling for smoking status and hemisphere of enrollment.||||||>0.05
70933252|NCT00705406|141367445|SUPERIORITY_OR_OTHER|||||||0.421|TWO_SIDED||||||van Elteren test|P-value is based on van Elteren test controlling for smoking status and hemisphere of enrollment.||||||0.421
70933253|NCT00705406|141367446|SUPERIORITY_OR_OTHER|||||||0.885|TWO_SIDED||||||Wilcoxon-Gehan test statistic|P-values are from a Wilcoxon-Gehan test statistic controlling for smoking status and hemisphere of enrollment.||||||0.885
70933254|NCT00705406|141367447|SUPERIORITY_OR_OTHER|||||||0.306|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value is based on the Cochran-Mantel-Haenszel general association test controlling for smoking status and hemisphere of enrollment.||||||0.306
70933255|NCT01079806|141367452|SUPERIORITY||Difference estimate|20.2||||0.0049|TWO_SIDED|95.0|9.1|31.4|||Normal approximation||Difference estimate is stratified by age randomization strata, using Cochran-Mantel-Haenszel weighting.|||31.4|9.1|0.0049
70933256|NCT01079806|141367453|SUPERIORITY||Difference estimate|41.8|||<|0.0001|TWO_SIDED|95.0|29.4|54.2|||Normal approximation||Difference estimate is stratified by age randomization strata, using Cochran-Mantel-Haenszel weighting.|||54.2|29.4|<0.0001
70933257|NCT01079806|141367454|SUPERIORITY||Difference estimate|45.2|||<|0.0001||95.0|29.2|61.2|||Normal approximation||Difference estimate is stratified by age randomization strata, using Cochran-Mantel-Haenszel weighting.|||61.2|29.2|<0.0001
70933258|NCT01079806|141367455|SUPERIORITY||Difference estimate|38.2|||<|0.0001|TWO_SIDED|95.0|25.9|50.5|||Normal approximation||Difference estimate is stratified by age randomization strata, using Cochran-Mantel-Haenszel weighting.|||50.5|25.9|<0.0001
70933259|NCT01079806|141367456|SUPERIORITY||Difference estimate|12.1||||0.11|TWO_SIDED|95.0|-1.5|25.7|||Normal approximation||Difference estimate is stratified by age randomization strata, using Cochran-Mantel-Haenszel weighting.|||25.7|-1.5|0.11
71022040|NCT01427920|141551972|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for subject-driven vs. investigator driven titration would be concluded if the upper bound of the two-sided 95% CI was below or equal to 0.4%.|Estimated treatment difference, Mean|0.26||||||95.0|0.05|0.48|||Regression, Linear|Model includes treatment, strata and region as factors and relevant baseline HbA1c as covariate.||PP||0.48|0.05|
71022041|NCT01427920|141551973|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|0.13||||0.659||95.0|-0.44|0.69|||Regression, Linear|Model includes treatment, strata and region as factors and relevant baseline FPG as covariate.||H0: D = 0.0% against HA: D ≠ 0.0%, where D is the mean treatment difference (subject-driven titration minus investigator-driven titration).||0.69|-0.44|0.659
71022042|NCT01202994|141552004|OTHER||correlation coefficient|-0.45|||<|0.05|TWO_SIDED|||||This is a calculated p-value.|correlation|||The primary analysis is to examine the correlation between the practice effect z-score (presented in the Secondary Outcome section) and the standardized uptake value of flutemetamol (presented in the Outcome module).||||<0.05
71022043|NCT00837577|141552015|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.92|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-1.09|-0.75||Adjusted for other prior antihyperglycemic medications (absence, presence).|Longitudinal data analysis (LDA)|LDA model included both baseline and post-baseline measurements as response variables. P-value calculated using least squares mean.||||-0.75|-1.09|<.001
71022044|NCT00837577|141552016|SUPERIORITY_OR_OTHER||Least squares mean difference|-51.3|STANDARD_ERROR_OF_MEAN|5.6|<|0.001|TWO_SIDED|95.0|-62.3|-40.2||Adjusted for other prior antihyperglycemic medications (absence, presence).|Longitudinal data analysis (LDA)|LDA model included both baseline and post-baseline measurements as response variables. P-value calculated using least squares mean.||||-40.2|-62.3|<.001
71022045|NCT00837577|141552017|SUPERIORITY_OR_OTHER||Least squares mean difference|-22.5|STANDARD_ERROR_OF_MEAN|3.8|<|0.001|TWO_SIDED|95.0|-30.0|-15.0||Adjusted for other prior antihyperglycemic medications (absence, presence).|Longitudinal data analysis (LDA)|LDA model included both baseline and post-baseline measurements as response variables. P-value calculated using least squares mean.||||-15.0|-30.0|<.001
71022046|NCT00272961|141552021|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|8.37|STANDARD_ERROR_OF_MEAN|6.19||0.185|TWO_SIDED|95.0|-4.21|20.96|||ANCOVA|||Sitting SBP: p-value was obtained using an Analysis of Co-variance (ANCOVA) model on the maximum increase observed with baseline value as a covariate.||20.96|-4.21|0.185
71022047|NCT00272961|141552021|SUPERIORITY_OR_OTHER||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|5.59||0.97|TWO_SIDED|95.0|-11.16|11.59|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||11.59|-11.16|0.970
71022048|NCT00272961|141552021|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|5.71||0.994|TWO_SIDED|95.0|-11.66|11.57|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||11.57|-11.66|0.994
71022049|NCT00272961|141552021|SUPERIORITY_OR_OTHER||LS Mean Difference|1.01|STANDARD_ERROR_OF_MEAN|5.72||0.861|TWO_SIDED|95.0|-10.62|12.64|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||12.64|-10.62|0.861
71055301|NCT01917916|141614610|OTHER||Slope|2.6033|STANDARD_ERROR_OF_MEAN|0.2499|||TWO_SIDED|95.0|2.0993|3.1073|||||Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is actually standard error of slope.|Dose proportionality was explored using the power model. Dose proportionality of BI 655064 was to be assessed based on the exposure parameter AUC0-∞, determined for the 4 subcutaneous dose levels. This analysis is for the overall population.||3.1073|2.0993|
71022050|NCT00272961|141552021|SUPERIORITY_OR_OTHER||LS Mean Difference|6.1|STANDARD_ERROR_OF_MEAN|4.9||0.221|TWO_SIDED|95.0|-3.79|15.99|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||15.99|-3.79|0.221
71022051|NCT00272961|141552021|SUPERIORITY_OR_OTHER||LS Mean Difference|0.68|STANDARD_ERROR_OF_MEAN|4.49||0.88|TWO_SIDED|95.0|-8.37|9.73|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||9.73|-8.37|0.880
71022052|NCT00272961|141552021|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|4.56||0.9|TWO_SIDED|95.0|-9.78|8.63|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||8.63|-9.78|0.900
71022053|NCT00272961|141552021|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.71|STANDARD_ERROR_OF_MEAN|4.56||0.218|TWO_SIDED|95.0|-14.91|3.5|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||3.50|-14.91|0.218
71022054|NCT00272961|141552021|SUPERIORITY_OR_OTHER||LS Mean Difference|5.62|STANDARD_ERROR_OF_MEAN|2.68||0.044|TWO_SIDED|95.0|0.17|11.08|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||11.08|0.17|0.044
71055302|NCT01917916|141614611|OTHER||Slope|3.1291|STANDARD_ERROR_OF_MEAN|0.392|||TWO_SIDED|95.0|2.3395|3.9187|||||Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is actually standard error of slope.|Dose proportionality was explored using the power model. Dose proportionality of BI 655064 was to be assessed based on the exposure parameter AUC0-tz, determined for the 4 subcutaneous dose levels. This analysis is for the overall population.||3.9187|2.3395|
71055303|NCT02618759|141614625|SUPERIORITY|||||||0.0745|||||||Cochran-Mantel-Haenszel|||||||0.0745
71055304|NCT02618759|141614626|SUPERIORITY|||||||0.231|||||||Cochran-Mantel-Haenszel|||||||0.2310
71055305|NCT02618759|141614627|SUPERIORITY|||||||0.1059|||||||Cochran-Mantel-Haenszel|||||||0.1059
71055306|NCT02618759|141614628|SUPERIORITY|||||||0.6962|||||||Cochran-Mantel-Haenszel|||||||0.6962
71055307|NCT02618759|141614629|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||||||1.0000
71022055|NCT00272961|141552021|SUPERIORITY_OR_OTHER||LS Mean Difference|1.43|STANDARD_ERROR_OF_MEAN|2.41||0.557|TWO_SIDED|95.0|-3.47|6.33|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||6.33|-3.47|0.557
71055308|NCT02618759|141614630|SUPERIORITY|||||||0.1044|||||||Cochran-Mantel-Haenszel|||||||0.1044
71055309|NCT03323437|141614638|OTHER|two way anova|||||<|0.01|||||||ANOVA|||||||<0.01
71055310|NCT03323437|141614639|OTHER|two way anova||||||0.68|||||||ANOVA|||||||.68
71055311|NCT03323437|141614640|OTHER|two way anova||||||0.03|||||||ANOVA|||||||.03
71055312|NCT03323437|141614641|OTHER|two way anova||||||0.01|||||||ANOVA|||||||.01
71022056|NCT00272961|141552021|SUPERIORITY_OR_OTHER||LS Mean Difference|6.37|STANDARD_ERROR_OF_MEAN|2.5||0.016|TWO_SIDED|95.0|1.28|11.45|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||11.45|1.28|0.016
71022057|NCT00272961|141552021|SUPERIORITY_OR_OTHER||LS Mean Difference|0.99|STANDARD_ERROR_OF_MEAN|2.5||0.695|TWO_SIDED|95.0|-4.09|6.07|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||6.07|-4.09|0.695
71022058|NCT00272961|141552021|SUPERIORITY_OR_OTHER||LS Mean Difference|4.8|STANDARD_ERROR_OF_MEAN|2.56||0.067|TWO_SIDED|95.0|-0.36|9.95|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||9.95|-0.36|0.067
71022059|NCT00272961|141552021|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|2.36||0.737|TWO_SIDED|95.0|-3.96|5.55|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||5.55|-3.96|0.737
71022060|NCT00272961|141552021|SUPERIORITY_OR_OTHER||LS Mean Difference|5.64|STANDARD_ERROR_OF_MEAN|2.4||0.023|TWO_SIDED|95.0|0.8|10.47|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||10.47|0.80|0.023
71055313|NCT03323437|141614642|OTHER|two sided t test||||||0.59|||||||t-test, 2 sided|||||||.59
71055314|NCT03323437|141614643|OTHER|two sided t test||||||0.45|||||||t-test, 2 sided|||||||.45
71055315|NCT03323437|141614644|OTHER|two way anova||||||0.32|||||||ANOVA|||||||.32
71022061|NCT00272961|141552021|SUPERIORITY_OR_OTHER||LS Mean Difference|1.65|STANDARD_ERROR_OF_MEAN|2.4||0.495|TWO_SIDED|95.0|-3.2|6.5|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||6.50|-3.20|0.495
71055316|NCT03323437|141614645|OTHER|two way anova||||||0.6|||||||ANOVA|||||||.60
70933260|NCT03732807|141367467|SUPERIORITY||Estimate of difference|29.11|||<|1e-06|TWO_SIDED|95.0|21.17|37.91|||Miettinen and Nurminen method|||||37.91|21.17|<0.000001
70933261|NCT03732807|141367467|SUPERIORITY||Estimate of difference|20.78|||<|1e-06|TWO_SIDED|95.0|13.65|29.18|||Miettinen and Nurminen method|||||29.18|13.65|<0.000001
71022062|NCT00272961|141552022|SUPERIORITY_OR_OTHER||LS Mean Difference|232.59|STANDARD_ERROR_OF_MEAN|201.83||0.2577|TWO_SIDED|95.0|-178.5|643.7|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||643.7|-178.5|0.2577
71022063|NCT00272961|141552022|SUPERIORITY_OR_OTHER||LS Mean Difference|103.67|STANDARD_ERROR_OF_MEAN|173.86||0.5552|TWO_SIDED|95.0|-250.5|457.8|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||457.8|-250.5|0.5552
71022064|NCT00272961|141552022|SUPERIORITY_OR_OTHER||LS Mean Difference|41.26|STANDARD_ERROR_OF_MEAN|177.26||0.8174|TWO_SIDED|95.0|-319.8|402.3|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||402.3|-319.8|0.8174
71022065|NCT00272961|141552022|SUPERIORITY_OR_OTHER||LS Mean Difference|166.4|STANDARD_ERROR_OF_MEAN|177.55||0.3557|TWO_SIDED|95.0|-195.3|528.1|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||528.1|-195.3|0.3557
71055317|NCT03323437|141614646|OTHER|two way anova||||||0.34|||||||ANOVA|||||||.34
70933262|NCT03732807|141367467|SUPERIORITY||Estimate of difference|21.85|||<|1e-06|TWO_SIDED|95.0|14.65|30.23|||Miettinen and Nurminen method|||||30.23|14.65|<0.000001
70933263|NCT03732807|141367467|SUPERIORITY||Estimate of difference|12.75||||0.000154|TWO_SIDED|95.0|6.69|20.36|||Miettinen and Nurminen method|||||20.36|6.69|0.000154
71022066|NCT00272961|141552022|SUPERIORITY_OR_OTHER||LS Mean Difference|163.04|STANDARD_ERROR_OF_MEAN|130.15||0.2172|TWO_SIDED|95.0|-99.6|425.7|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||425.7|-99.6|0.2172
71022067|NCT00272961|141552022|SUPERIORITY_OR_OTHER||LS Mean Difference|115.35|STANDARD_ERROR_OF_MEAN|116.03||0.3258|TWO_SIDED|95.0|-118.8|349.5|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||349.5|-118.8|0.3258
71055318|NCT03323437|141614647|OTHER|two way anova||||||0.35|||||||ANOVA|||||||.35
71055319|NCT03323437|141614648|OTHER|fisher's exact||||||0.66|||||||Fisher Exact|||||||.66
71055320|NCT03323437|141614649|OTHER|two sided t test||||||0.04|||||||t-test, 2 sided|||||||.04
71055321|NCT03323437|141614650|OTHER|fisher's exact test||||||1|||||||Fisher Exact|||||||1
71055322|NCT00605540|141614651|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Wilcoxon (Mann-Whitney)|||All data were analyzed using SigmaStat 3.2 (Inc., USA) software. Mean ± SD or median interquartile range (25-75%) was used depending on the data distribution. Wilcoxon test was applied to compare the characteristics at baseline to those observed after 3 years.||||0.09
71055323|NCT00049530|141614660|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||bionomial proportion test|||It is of interest to test the null hypothesis of 10% plasma b-FGF response rate versus the alternative hypothesis of 30% response rate. Based on the sample size of 30 eligible patients, there will be 84% power to detect this 20% difference in b-FGF response rates. This was based on a two-sided type I error of .05, using the one-sample binomial test.||||<0.001
71055324|NCT02383810|141614664|SUPERIORITY|The overall hypothesis system was represented by the following pool of partial hypothesis systems: Hok: πGi = πGj i = 1 to 3, and j = 2 to 4, and k = 1 to 6, and i ≠ j HAk: πGi ≠πGj i = 1 to 3, and j = 2 to 4, and k = 1 to 6, and i ≠ j where πG is the probability of absence of Grade ≥2 CID for the Group. Each Ho involved 2 groups.|||||<|0.1||||||Overall alpha level 0.10 was maintained by correction for multiplicity according to Hommel's procedure.|Chi-squared|||Overall null hypothesis: All elsiglutide dose groups had equal proportion of subjects with max Grade≥2 diarrhea and this was equal to the one in the placebo group. This includes 6 individual hypotheses (i.e., 3 to compare each dose group vs. placebo and 3 to compare dose groups vs. each other). Raw p-values from Chi square tests were corrected for multiplicity according to the Hommel's procedure. Each of 6 hypotheses was then evaluated based on corrected p-value at alpha 0.10 (two-sided).||||<0.1
70933264|NCT03732807|141367468|SUPERIORITY||Estimate of difference|19.75|||<|1e-06|TWO_SIDED|95.0|11.91|27.59|||Miettinen and Nurminen method|||A generalized linear mixed effect model without imputation using observed data up to Week 24 was used as the imputation model. A single complete imputed data set for Week 24 was analyzed using the Miettinen and Nurminen method as the analysis model.||27.59|11.91|<0.000001
71055325|NCT01696058|141614698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.078|0.135|||Mixed Model Repeated Measure|||Results are from an mixed model repeated measure (MMRM) model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (566), Tio+Olo 5ug (563).||0.135|0.078|<.0001
70933265|NCT03732807|141367468|SUPERIORITY||Estimate of difference|11.33||||0.000526||95.0|4.93|17.74|||Miettinen and Nurminen method|||A generalized linear mixed effect model without imputation using observed data up to Week 24 was used as the imputation model. A single complete imputed data set for Week 24 was analyzed using the Miettinen and Nurminen method as the analysis model.||17.74|4.93|0.000526
70933266|NCT03732807|141367468|SUPERIORITY||Estimate of difference|11.88||||0.000311||95.0|5.42|18.33|||Miettinen and Nurminen method|||A generalized linear mixed effect model without imputation using observed data up to Week 24 was used as the imputation model. A single complete imputed data set for Week 24 was analyzed using the Miettinen and Nurminen method as the analysis model.||18.33|5.42|0.000311
70933267|NCT03732807|141367468|SUPERIORITY||Estimate of difference|9.09||||0.002922||95.0|3.1|15.07|||Miettinen and Nurminen method|||A generalized linear mixed effect model without imputation using observed data up to Week 24 was used as the imputation model. A single complete imputed data set for Week 24 was analyzed using the Miettinen and Nurminen method as the analysis model.||15.07|3.10|0.002922
70933268|NCT03732807|141367469|SUPERIORITY||Estimate of difference|20.24|||<|1e-06||95.0|13.23|28.49|||Miettinen and Nurminen method|||||28.49|13.23|<0.000001
70933269|NCT03732807|141367469|SUPERIORITY||Estimate of difference|11.68||||0.000337||95.0|5.82|19.07|||Miettinen and Nurminen method|||||19.07|5.82|0.000337
70933270|NCT03732807|141367469|SUPERIORITY||Estimate of difference|12.17||||0.000228||95.0|6.27|19.53|||Miettinen and Nurminen method|||||19.53|6.27|0.000228
70933271|NCT03732807|141367469|SUPERIORITY||Estimate of difference|9.39||||0.001875|TWO_SIDED|95.0|3.86|16.46|||Miettinen and Nurminen method|||||16.46|3.86|0.001875
70933272|NCT03732807|141367470|SUPERIORITY||Estimate of difference|42.96|||<|1e-06|TWO_SIDED|95.0|31.68|54.25|||Miettinen and Nurminen method|||||54.25|31.68|<0.000001
70933273|NCT03732807|141367470|SUPERIORITY||Estimate of difference|36.18|||<|1e-06|TWO_SIDED|95.0|25.22|47.14|||Miettinen and Nurminen method|||||47.14|25.22|<0.000001
70933274|NCT03732807|141367470|SUPERIORITY||Estimate of difference|39.96|||<|1e-06|TWO_SIDED|95.0|28.85|51.06|||Miettinen and Nurminen method|||||51.06|28.85|<0.000001
70933275|NCT03732807|141367470|SUPERIORITY||Estimate of difference|32.72|||<|1e-06|TWO_SIDED|95.0|21.95|43.5|||Miettinen and Nurminen method|||||43.50|21.95|<0.000001
70933276|NCT00683800|141367510|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.89|||<|0.001|TWO_SIDED|95.0|-3.8|-1.98|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided).||-1.98|-3.80|<0.001
70933277|NCT00683800|141367511|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.79|||<|0.001|TWO_SIDED|95.0|-3.77|-1.82|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided).||-1.82|-3.77|<0.001
70933278|NCT00683800|141367512|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.28|||<|0.001|TWO_SIDED|95.0|-0.4|-0.16|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided).||-0.16|-0.40|<0.001
70933279|NCT00683800|141367513|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.44|-0.18|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided).||-0.18|-0.44|<0.001
70933280|NCT00683800|141367514|SUPERIORITY_OR_OTHER||Wald Formula|-1.07|||||TWO_SIDED|90.0|-2.86|0.72|||||The 90% CI for excess risk was obtained using the Wald Formula.|Excess risk of DVS SR 100 mg over placebo per 1000 woman-years of exposure, defined as the difference in the exposure adjusted rates between the treatment groups, was obtained.||0.72|-2.86|
70933281|NCT00683800|141367515|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||The proportion of participants achieving a response as defined by minimal clinically important difference (MCID) at week 12 was compared between DVS and placebo treatment groups with a Cochran-Mantel-Haenszel test.||||<0.001
70933282|NCT00683800|141367516|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.47|||<|0.001|TWO_SIDED|95.0|2.24|5.36|||Regression, Logistic|||The proportion of participants achieving at least 50% hot flush reduction from baseline at 4-week was compared between DVS and placebo treatment groups with a logistic regression model with treatment as factor and baseline value as a covariate.||5.36|2.24|<0.001
70933283|NCT00683800|141367516|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.67|||<|0.001|TWO_SIDED|95.0|1.75|4.1|||Regression, Logistic|||The proportion of participants achieving at least 50% hot flush reduction from baseline at 12-week was compared between DVS and placebo treatment groups with a logistic regression model with treatment as factor and baseline value as a covariate.||4.10|1.75|<0.001
70933284|NCT00683800|141367517|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.39|||<|0.001|TWO_SIDED|95.0|2.47|7.81|||Regression, Logistic|||The proportion of participants achieving at least 75% hot flush reduction from baseline at 4-week was compared between DVS and placebo treatment groups with a logistic regression model with treatment as factor and baseline value as a covariate.||7.81|2.47|<0.001
70933285|NCT00683800|141367517|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.16|||<|0.001|TWO_SIDED|95.0|1.96|5.09|||Regression, Logistic|||The proportion of participants achieving at least 75% hot flush reduction from baseline at 12-week was compared between DVS and placebo treatment groups with a logistic regression model with treatment as factor and baseline value as a covariate.||5.09|1.96|<0.001
71022068|NCT00272961|141552022|SUPERIORITY_OR_OTHER||LS Mean Difference|24.67|STANDARD_ERROR_OF_MEAN|117.88||0.8352|TWO_SIDED|95.0|-213.2|262.6|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||262.6|-213.2|0.8352
71022069|NCT00272961|141552022|SUPERIORITY_OR_OTHER||LS Mean Difference|50.59|STANDARD_ERROR_OF_MEAN|117.93||0.6701|TWO_SIDED|95.0|-187.4|288.6|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||288.6|-187.4|0.6701
71022070|NCT00272961|141552022|SUPERIORITY_OR_OTHER||LS Mean Difference|225.57|STANDARD_ERROR_OF_MEAN|108.95||0.0466|TWO_SIDED|95.0|3.6|447.5|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||447.5|3.6|0.0466
71022071|NCT00272961|141552022|SUPERIORITY_OR_OTHER||LS Mean Difference|114.77|STANDARD_ERROR_OF_MEAN|93.2637||0.2274|TWO_SIDED|95.0|-75.2|304.8|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||304.8|-75.2|0.2274
71022072|NCT00272961|141552022|SUPERIORITY_OR_OTHER||LS Mean Difference|224.89|STANDARD_ERROR_OF_MEAN|96.9259||0.0269|TWO_SIDED|95.0|27.5|422.3|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||422.3|27.5|0.0269
71022073|NCT00272961|141552022|SUPERIORITY_OR_OTHER||LS Mean Difference|133.22|STANDARD_ERROR_OF_MEAN|96.7383||0.178|TWO_SIDED|95.0|-63.8|330.3|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||330.3|-63.8|0.1780
71022074|NCT00272961|141552022|SUPERIORITY_OR_OTHER||LS Mean Difference|240.64|STANDARD_ERROR_OF_MEAN|114.32||0.0413|TWO_SIDED|95.0|9.9|471.4|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||471.4|9.9|0.0413
71055326|NCT01696058|141614699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.013||0.0029|TWO_SIDED|95.0|0.014|0.065|||Mixed Model Repeated Measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (555), Tio+Olo 5ug (550).||0.065|0.014|0.0029
71055327|NCT01696058|141614700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.854|STANDARD_ERROR_OF_MEAN|0.461|<|0.0001|TWO_SIDED|95.0|-2.757|-0.951|||ANCOVA|||"Results are from ANCOVA model. Fixed effects include study, treatment and baseline.~Number of patients contributing to models: Tio+Placebo (1055), Tio+Olo 5ug (1039)."||-0.951|-2.757|<.0001
71055328|NCT01696058|141614701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.071|0.129|||Mixed Model Repeated Measure|||"Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used.~Number of patients contributing to models: Tio+Placebo (566), Tio+Olo 5ug (563)."||0.129|0.071|<.0001
71055329|NCT01696058|141614702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.072|0.164|||Mixed Model Repeated Measure|||"Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used.~Number of patients contributing to models: Tio+Placebo (566), Tio+Olo 5ug (563)."||0.164|0.072|<.0001
70933286|NCT00683800|141367518|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Log Rank|||A log-rank test was used to compare the treatment groups.||||<0.001
71022075|NCT00272961|141552022|SUPERIORITY_OR_OTHER||LS Mean Difference|157.99|STANDARD_ERROR_OF_MEAN|102.21||0.1297|TWO_SIDED|95.0|-48.3|364.3|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||364.3|-48.3|0.1297
71022076|NCT00272961|141552022|SUPERIORITY_OR_OTHER||LS Mean Difference|254.9|STANDARD_ERROR_OF_MEAN|104.0||0.0185|TWO_SIDED|95.0|45.0|464.8|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||464.8|45.0|0.0185
71022077|NCT00272961|141552022|SUPERIORITY_OR_OTHER||LS Mean Difference|157.66|STANDARD_ERROR_OF_MEAN|104.33||0.1382|TWO_SIDED|95.0|-52.9|368.2|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||368.2|-52.9|0.1382
71022078|NCT00272961|141552027|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86|STANDARD_ERROR_OF_MEAN|3.0||0.7758|TWO_SIDED|95.0|-5.31|7.03|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||7.03|-5.31|0.7758
71022079|NCT00272961|141552027|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|2.45||0.888|TWO_SIDED|95.0|-5.4|4.71|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||4.71|-5.40|0.8880
71022080|NCT00272961|141552027|SUPERIORITY_OR_OTHER||LS Mean Difference|1.86|STANDARD_ERROR_OF_MEAN|2.46||0.4573|TWO_SIDED|95.0|-3.21|6.93|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||6.93|-3.21|0.4573
71022081|NCT00272961|141552027|SUPERIORITY_OR_OTHER||LS Mean Difference|2.17|STANDARD_ERROR_OF_MEAN|2.78||0.4424|TWO_SIDED|95.0|-3.56|7.91|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||7.91|-3.56|0.4424
71022082|NCT00272961|141552027|SUPERIORITY_OR_OTHER||LS Mean Difference|3.18|STANDARD_ERROR_OF_MEAN|3.32||0.347|TWO_SIDED|95.0|-3.65|10.01|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||10.01|-3.65|0.3470
70933287|NCT00683800|141367519|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.04|||<|0.001|TWO_SIDED|95.0|-3.07|-1.0|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided). (At month 6)||-1.00|-3.07|<0.001
70933288|NCT00683800|141367519|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.81|||<|0.001|TWO_SIDED|95.0|-4.12|-1.51|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided). (At month 12)||-1.51|-4.12|<0.001
70933289|NCT00683800|141367520|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.31||||0.002|TWO_SIDED|95.0|-0.51|-0.12|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided). (At month 6)||-0.12|-0.51|0.002
70933290|NCT00683800|141367520|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.33||||0.003|TWO_SIDED|95.0|-0.54|-0.11|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided). (At month 12)||-0.11|-0.54|0.003
70933291|NCT00683800|141367521|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.34|||<|0.001|TWO_SIDED|95.0|-3.05|-1.64|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Total score was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-1.64|-3.05|<0.001
71022083|NCT00272961|141552027|SUPERIORITY_OR_OTHER||LS Mean Difference|1.34|STANDARD_ERROR_OF_MEAN|2.72||0.6249|TWO_SIDED|95.0|-4.25|6.94|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||6.94|-4.25|0.6249
70933292|NCT00683800|141367521|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-0.99|-0.51|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Anxiety scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.51|-0.99|<0.001
70933293|NCT00683800|141367521|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.67|||<|0.001|TWO_SIDED|95.0|-0.89|-0.45|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Depression scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.45|-0.89|<0.001
71022084|NCT00272961|141552027|SUPERIORITY_OR_OTHER||LS Mean Difference|3.92|STANDARD_ERROR_OF_MEAN|2.73||0.1625|TWO_SIDED|95.0|-1.69|9.54|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||9.54|-1.69|0.1625
71055330|NCT01696058|141614703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.057|0.152|||Mixed Model Repeated Measure|||"Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used.~Number of patients contributing to models: Tio+Placebo (566), Tio+Olo 5ug (563)."||0.152|0.057|<.0001
71055331|NCT01696058|141614704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.034|STANDARD_ERROR_OF_MEAN|0.022||0.1156|TWO_SIDED|95.0|-0.008|0.076|||Mixed Model Repeated Measure|||"Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used.~Number of patients contributing to models: Tio+Placebo (555), Tio+Olo 5ug (550)."||0.076|-0.008|0.1156
71055332|NCT01696058|141614705|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|7.237|STANDARD_ERROR_OF_MEAN|2.145||0.0008|TWO_SIDED|95.0|3.028|11.446|||ANCOVA|||"Week 12: Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (552)."||11.446|3.028|0.0008
71055333|NCT01696058|141614706|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|-0.568|STANDARD_ERROR_OF_MEAN|0.118|<|0.0001|TWO_SIDED|95.0|-0.8|-0.336|||ANCOVA|||"Week 12 - Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)."||-0.336|-0.800|<.0001
71107108|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.13|||<|0.001|TWO_SIDED|95.0|0.95|1.35||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 23F: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.35|0.95|<0.001
70933294|NCT00683800|141367521|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05||||0.162|TWO_SIDED|95.0|-0.13|0.02|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Sexual Dysfunction scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||0.02|-0.13|0.162
70933295|NCT00683800|141367521|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.42|||<|0.001|TWO_SIDED|95.0|-1.84|-1.0|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Psychological scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 was outcome variable, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-1.00|-1.84|<0.001
71022085|NCT00272961|141552027|SUPERIORITY_OR_OTHER||LS Mean Difference|0.97|STANDARD_ERROR_OF_MEAN|3.08||0.7556|TWO_SIDED|95.0|-5.38|7.31|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||7.31|-5.38|0.7556
71022086|NCT00272961|141552028|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.99|STANDARD_ERROR_OF_MEAN|1.59||0.0714|TWO_SIDED|95.0|-6.25|0.28|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||0.28|-6.25|0.0714
71022087|NCT00272961|141552028|SUPERIORITY_OR_OTHER||LS Mean Difference|0.47|STANDARD_ERROR_OF_MEAN|1.34||0.7269|TWO_SIDED|95.0|-2.29|3.24|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||3.24|-2.29|0.7269
71022088|NCT00272961|141552028|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|1.36||0.8656|TWO_SIDED|95.0|-2.58|3.04|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||3.04|-2.58|0.8656
71022089|NCT00272961|141552028|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|1.4||0.7113|TWO_SIDED|95.0|-3.41|2.36|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||2.36|-3.41|0.7113
71022090|NCT00272961|141552028|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.77|STANDARD_ERROR_OF_MEAN|2.21||0.2204|TWO_SIDED|95.0|-7.32|1.77|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||1.77|-7.32|0.2204
71022091|NCT00272961|141552028|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|1.87||0.5298|TWO_SIDED|95.0|-5.04|2.66|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||2.66|-5.04|0.5298
71022092|NCT00272961|141552028|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.95|STANDARD_ERROR_OF_MEAN|1.9||0.3135|TWO_SIDED|95.0|-5.86|1.96|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||1.96|-5.86|0.3135
70933296|NCT00683800|141367521|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.22||||0.066|TWO_SIDED|95.0|-0.46|0.01|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Somatic scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||0.01|-0.46|0.066
71022093|NCT00272961|141552028|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.08|STANDARD_ERROR_OF_MEAN|1.95||0.2962|TWO_SIDED|95.0|-6.09|1.93|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||1.93|-6.09|0.2962
71022094|NCT00272961|141552029|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.74|STANDARD_ERROR_OF_MEAN|5.39||0.4933|TWO_SIDED|95.0|-14.84|7.35|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||7.35|-14.84|0.4933
71022095|NCT00272961|141552029|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.85|STANDARD_ERROR_OF_MEAN|4.57||0.408|TWO_SIDED|95.0|-13.26|5.57|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||5.57|-13.26|0.4080
71022096|NCT00272961|141552029|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.47|STANDARD_ERROR_OF_MEAN|4.56||0.5936|TWO_SIDED|95.0|-11.86|6.93|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||6.93|-11.86|0.5936
71022097|NCT00272961|141552029|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|4.79||0.7883|TWO_SIDED|95.0|-11.17|8.57|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||8.57|-11.17|0.7883
71022098|NCT00272961|141552029|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.93|STANDARD_ERROR_OF_MEAN|5.12||0.5719|TWO_SIDED|95.0|-13.46|7.6|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||7.60|-13.46|0.5719
71055334|NCT01696058|141614707|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 1|-0.09|STANDARD_ERROR_OF_MEAN|0.045||0.0467|TWO_SIDED|95.0|-0.178|-0.001|||ANCOVA|||"Week 12 - Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)."||-0.001|-0.178|0.0467
71055335|NCT01696058|141614708|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|-0.483|STANDARD_ERROR_OF_MEAN|0.094|<|0.0001|TWO_SIDED|95.0|-0.668|-0.298|||ANCOVA|||"Week 12 - Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)."||-0.298|-0.668|<.0001
71055336|NCT01934335|141614709|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.51
71022099|NCT00272961|141552029|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.21|STANDARD_ERROR_OF_MEAN|4.33||0.3401|TWO_SIDED|95.0|-13.11|4.7|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||4.70|-13.11|0.3401
71055337|NCT01934335|141614710|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||0.35
71055338|NCT01934335|141614711|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||||||0.43
71055339|NCT05384171|141614715|SUPERIORITY||Partial Eta Squared (effect size)|0.02||||0.617|TWO_SIDED||||||ANCOVA|||||||.617
71055340|NCT05384171|141614717|SUPERIORITY||Partial Eta Squared (effect size)|0.089||||0.214|TWO_SIDED||||||ANCOVA|||Null hypothesis: Intervention and active control group intention follow-up means are equal when controlling for covariates (i.e., baseline intention scores and age)||||.214
71022100|NCT00272961|141552029|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|4.34||0.6329|TWO_SIDED|95.0|-11.01|6.82|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||6.82|-11.01|0.6329
71055341|NCT05384171|141614717|SUPERIORITY||Partial Eta Squared (effect size)|0.001||||0.894|TWO_SIDED||||||ANCOVA|||Null hypothesis: Intervention and active control group attitude follow-up means are equal when controlling for covariates (i.e., baseline attitude scores and age)||||.894
71055342|NCT05384171|141614717|SUPERIORITY||Partial Eta Squared (Effect Size)|0.053||||0.359|TWO_SIDED||||||ANCOVA|||Null hypothesis: Intervention and active control group social norms follow-up means are equal when controlling for covariates (i.e., baseline social norms scores and age)||||.359
71055343|NCT05384171|141614717|SUPERIORITY||Partial Eta Squared (Effect Size)|0.058||||0.322|TWO_SIDED||||||ANCOVA|||Null hypothesis: Intervention and active control group perceived behavioral control follow-up means are equal when controlling for covariates (i.e., baseline perceived behavioral control scores and age)||||.322
70933297|NCT00683800|141367521|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.64|||<|0.001|TWO_SIDED|95.0|-0.79|-0.5|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Vasomotor scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.50|-0.79|<0.001
70933298|NCT00683800|141367522|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.87|||<|0.001|TWO_SIDED|95.0|-2.57|-1.18|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Total score was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-1.18|-2.57|<0.001
70933299|NCT00683800|141367522|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.65|||<|0.001|TWO_SIDED|95.0|-0.9|-0.41|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Anxiety scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.41|-0.90|<0.001
70933300|NCT00683800|141367522|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.58|||<|0.001|TWO_SIDED|95.0|-0.8|-0.37|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Depression scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.37|-0.80|<0.001
70933301|NCT00683800|141367522|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.04||||0.282|TWO_SIDED|95.0|-0.13|0.04|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Sexual Dysfunction scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||0.04|-0.13|0.282
70933302|NCT00683800|141367522|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.24|||<|0.001|TWO_SIDED|95.0|-1.66|-0.82|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Psychological scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.82|-1.66|<0.001
70933303|NCT00683800|141367522|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.17||||0.14|TWO_SIDED|95.0|-0.41|0.06|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Somatic scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||0.06|-0.41|0.140
71022101|NCT00272961|141552029|SUPERIORITY_OR_OTHER||LS Mean Difference|3.83|STANDARD_ERROR_OF_MEAN|4.51||0.4037|TWO_SIDED|95.0|-5.45|13.11|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||13.11|-5.45|0.4037
71022102|NCT00272961|141552030|SUPERIORITY_OR_OTHER||LS Mean Difference|1.21|STANDARD_ERROR_OF_MEAN|4.08||0.7685|TWO_SIDED|95.0|-7.19|9.62|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||9.62|-7.19|0.7685
71022103|NCT00272961|141552030|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.88|STANDARD_ERROR_OF_MEAN|3.49||0.1739|TWO_SIDED|95.0|-12.07|2.3|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||2.30|-12.07|0.1739
71022104|NCT00272961|141552030|SUPERIORITY_OR_OTHER||LS Mean Difference|2.71|STANDARD_ERROR_OF_MEAN|3.61||0.4612|TWO_SIDED|95.0|-4.74|10.15|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||10.15|-4.74|0.4612
70933304|NCT00683800|141367522|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.41|||<|0.001|TWO_SIDED|95.0|-0.56|-0.26|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Vasomotor scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.26|-0.56|<0.001
71022105|NCT00272961|141552030|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|3.67||0.7172|TWO_SIDED|95.0|-8.9|6.21|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||6.21|-8.90|0.7172
71022106|NCT00272961|141552030|SUPERIORITY_OR_OTHER||LS Mean Difference|3.45|STANDARD_ERROR_OF_MEAN|4.12||0.4098|TWO_SIDED|95.0|-5.01|11.91|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||11.91|-5.01|0.4098
71055344|NCT05384171|141614718|SUPERIORITY||Partial Eta Squared (effect size)|0.001||||0.891|TWO_SIDED||||||ANCOVA|||||||.891
71055345|NCT00106964|141614720|SUPERIORITY_OR_OTHER|||||||0.044|||||||Chi-squared|||||||0.0440
71055346|NCT00106964|141614720|SUPERIORITY_OR_OTHER|||||||0.0157|||||||Chi-squared|||||||0.0157
71055347|NCT00106964|141614724|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.5822||95.0|||||Regression, Cox|||||||0.5822
71055348|NCT00106964|141614724|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.8698||95.0|||||Regression, Cox|||||||0.8698
71055349|NCT00106964|141614725|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.29||||0.0853|TWO_SIDED|95.0|0.07|1.19|||Regression, Logistic||Adjusted odds ratio (OR) Odds ratio depends on CD4 count resulting from interaction. For example, OR=0.29 for CD4 count = 0; OR= 2.91 for CD4 count = 460 (median CD4 count for the evaluable study population).|||1.19|0.07|0.0853
71022107|NCT00272961|141552030|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.38|STANDARD_ERROR_OF_MEAN|3.48||0.6943|TWO_SIDED|95.0|-8.54|5.78|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||5.78|-8.54|0.6943
71022108|NCT00272961|141552030|SUPERIORITY_OR_OTHER||LS Mean Difference|4.78|STANDARD_ERROR_OF_MEAN|3.67||0.2042|TWO_SIDED|95.0|-2.76|12.31|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||12.31|-2.76|0.2042
71022109|NCT00272961|141552030|SUPERIORITY_OR_OTHER||LS Mean Difference|1.07|STANDARD_ERROR_OF_MEAN|3.77||0.7791|TWO_SIDED|95.0|-6.69|8.83|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||8.83|-6.69|0.7791
71022110|NCT02065791|141552031|SUPERIORITY||Hazard Ratio (HR)|0.7|||<|0.0001|TWO_SIDED|95.0|0.59|0.82|||Cox Proportional Hazard|||Comparison for canagliflozin versus placebo is reported here.||0.82|0.59|< 0.0001
71022111|NCT02065791|141552032|SUPERIORITY||Hazard Ratio (HR)|0.69|||=|0.0001|TWO_SIDED|95.0|0.57|0.83|||Cox proportional hazard|||Comparison for canagliflozin versus placebo is reported here.||0.83|0.57|=0.0001
71055350|NCT00106964|141614725|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.99||||0.0244|TWO_SIDED|95.0|1.09|3.63|||Regression, Logistic||Adjusted odds ratio|||3.63|1.09|0.0244
71055351|NCT00168818|141614733|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 7.7%. This results from the null-hypotheses of non-inferiority testing, where the rate difference has to be below 7.7%. Non-inferiority can only be shown with CI.|Risk Difference (Percentage)|-0.7||||0.5648||95.0|-2.9|1.6||p-value is for superiority testing|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||1.6|-2.9|0.5648
71107109|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.95|||<|0.001|TWO_SIDED|95.0|0.81|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 22F: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.11|0.81|<0.001
71107110|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.98|||<|0.001|TWO_SIDED|95.0|0.84|1.14||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 22F: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.14|0.84|<0.001
71107111|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.88|1.21||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 22F: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.21|0.88|<0.001
70933305|NCT00683800|141367523|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.71|||<|0.001|TWO_SIDED|95.0|-2.42|-1.0|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Total score was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-1.00|-2.42|<0.001
71022112|NCT02065791|141552033|SUPERIORITY||Hazard Ratio (HR)|0.8|||=|0.0121|TWO_SIDED|95.0|0.67|0.95|||Cox proportional hazard|||Comparison for canagliflozin versus placebo is reported here.||0.95|0.67|=0.0121
71022113|NCT02065791|141552034|SUPERIORITY||Hazard Ratio (HR)|0.61|||=|0.0003|TWO_SIDED|95.0|0.47|0.8|||Cox proportional hazards|||Comparison for canagliflozin versus placebo is reported here.||0.80|0.47|=0.0003
71022114|NCT02065791|141552035|SUPERIORITY||Hazard Ratio (HR)|0.66|||<|0.0001|TWO_SIDED|95.0|0.53|0.81|||Cox proportional hazards|||Comparison for canagliflozin versus placebo is reported here.||0.81|0.53|<0.0001
71022115|NCT02065791|141552036|SUPERIORITY||Hazard Ratio (HR)|0.78|||=|0.0502|TWO_SIDED|95.0|0.61|1.0|||Cox proportional hazards|||Comparison for canagliflozin versus placebo is reported here.||1.00|0.61|=0.0502
71022116|NCT02065791|141552037|SUPERIORITY||Hazard Ratio (HR)|0.83|||=|0.0727|TWO_SIDED|95.0|0.68|1.02|||Cox proportional hazard|||Comparison for canagliflozin versus placebo is reported here.||1.02|0.68|= 0.0727
71022117|NCT02065791|141552038|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0001|TWO_SIDED|95.0|0.63|0.86|||Cox proportional hazards|||Comparison for canagliflozin versus placebo is reported here.||0.86|0.63|0.0001
71022118|NCT01890785|141552039|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.708|||||TWO_SIDED|90.0|0.655|0.766||||||||0.766|0.655|
71022119|NCT01890785|141552039|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.918|||||TWO_SIDED|90.0|0.849|0.992||||||||0.992|0.849|
71022120|NCT01890785|141552040|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.641|||||TWO_SIDED|90.0|0.582|0.707||||||||0.707|0.582|
71022121|NCT01890785|141552040|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.828|||||TWO_SIDED|90.0|0.752|0.912||||||||0.912|0.752|
71022122|NCT01890785|141552041|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.97|||||TWO_SIDED|90.0|0.937|1.004||||||||1.004|0.937|
71107112|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.86|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 33F: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.16|0.86|<0.001
71022123|NCT01890785|141552041|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.944|||||TWO_SIDED|90.0|0.912|0.977||||||||0.977|0.912|
71022124|NCT01890785|141552042|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.971|||||TWO_SIDED|90.0|0.945|0.998||||||||0.998|0.945|
71022125|NCT01890785|141552042|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.97|||||TWO_SIDED|90.0|0.944|0.997||||||||0.997|0.944|
71022126|NCT00575328|141552046|SUPERIORITY|Analysis is a test of statistical significance to evaluate whether the results are consistent with the assumption of there being no difference in the clinical improvement (i.e. change in ASEX score) of the two treatments (null hypothesis).|Mean Difference (Final Values)|1.8|STANDARD_DEVIATION|3.3||0.62|TWO_SIDED|95.0|-8.7|12.3||No adjustment for multiple comparisons. P value for significance set a priori at P\<0.05.|t-test, 2 sided|||Null hypothesis: There will be no difference in clinical improvement (i.e. change in ASEX score) between treatment arms. No formal power analysis was carried out, given the small study sample.|The analysis is not truly informative, since the analyzable sample (n=6) was too small. Results should be viewed with caution.|12.3|-8.7|0.62
71022127|NCT00575328|141552047|SUPERIORITY|Analysis is a test of statistical significance to evaluate whether the results are consistent with the assumption of there being no difference in the clinical improvement (i.e. change in MGH-SD score) of the two treatments (null hypothesis).|Mean Difference (Final Values)|3.6|STANDARD_DEVIATION|4.5||0.38|TWO_SIDED|95.0|-6.7|13.97||No adjustment for multiple comparisons. P value for significance set a priori at P\<0.05.|t-test, 2 sided|||Null hypothesis: There will be no difference in clinical improvement (i.e. change in MGH-SD score) between treatment arms. No formal power analysis was carried out, given the small study sample.|Analysis was not truly informative since the analyzable sample (n=6) was too small. Results should be interpreted with caution.|13.97|-6.7|0.38
71022128|NCT00397839|141552059|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.58|||<|0.001||95.0|1.41|3.76|||ANCOVA|||||3.76|1.41|<0.001
71022129|NCT00397839|141552060|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.86||||0.118||95.0|-0.22|1.94|||ANCOVA|||||1.94|-0.22|0.118
71022130|NCT00397839|141552061|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.13|||<|0.001||95.0|1.34|2.92|||ANCOVA|||Total Hip subgroup||2.92|1.34|<0.001
71022131|NCT00397839|141552061|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.43||||0.012||95.0|0.32|2.55|||ANCOVA|||Femoral Neckm subgroup||2.55|0.32|0.012
71022132|NCT00397839|141552061|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.72||||0.004||95.0|0.56|2.88|||ANCOVA|||Trochanter subgroup||2.88|0.56|0.004
71022133|NCT00397839|141552062|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.75|||<|0.001||95.0|1.11|2.4|||ANCOVA|||Total Hip subgroup||2.40|1.11|<0.001
71022134|NCT00397839|141552062|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.18||||0.031||95.0|0.11|2.25|||ANCOVA|||Femoral Neck subgroup||2.25|0.11|0.031
71022135|NCT00397839|141552062|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.18||||0.031||95.0|0.11|2.25|||ANCOVA|||Trochanter subgroup||2.25|0.11|0.031
71022136|NCT00397839|141552063|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.91||||0.362||95.0|0.73|1.13|||Cochran-Mantel-Haenszel||Relative risk|Total Spine BMD at Month 6||1.13|0.73|0.362
71022137|NCT00397839|141552063|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.85||||0.044||95.0|0.72|1.01|||Cochran-Mantel-Haenszel||Relative risk|Total Spine BMD at Month 12||1.01|0.72|0.044
71022138|NCT00397839|141552063|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|||<|0.001||95.0|0.3|0.72|||Cochran-Mantel-Haenszel||Relative risk|Total Hip BMD at Month 6||0.72|0.30|<0.001
71022139|NCT00397839|141552063|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.57|||<|0.001||95.0|0.41|0.8|||Cochran-Mantel-Haenszel||Relative risk|Total Hip BMD at Month 12||0.80|0.41|<0.001
71022140|NCT00397839|141552063|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41|||<|0.001||95.0|0.23|0.72|||Cochran-Mantel-Haenszel||Relative risk|Both Total Hip and Total Spine BMD at Month 6||0.72|0.23|<0.001
71022141|NCT00397839|141552063|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|||<|0.001||95.0|0.33|0.75|||Cochran-Mantel-Haenszel||Relative risk|Both Total Hip and Total Spine BMD||0.75|0.33|<0.001
71022142|NCT02522949|141552082|SUPERIORITY|||||||0.7146|||||||ANCOVA|||Oropharyngeal||||0.7146
71022143|NCT02522949|141552082|SUPERIORITY|||||||0.3543|||||||ANCOVA|||Nasal||||0.3543
71022144|NCT02522949|141552090|OTHER|||||||0.0232|||||||Exact Wilcoxon rank sum test|||||||0.0232
71022145|NCT02191579|141552110|SUPERIORITY||Odds Ratio (OR)|4.94|||<|0.001|TWO_SIDED|95.0|2.681|9.085||Odds ratio, 95% CI, and p-value were estimated using a logistic regression model adjusted by baseline headache days.|Regression, Logistic|||||9.085|2.681|<0.001
71055352|NCT00168818|141614733|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 7.7%. This results from the null-hypotheses of non-inferiority testing, where the rate difference has to be below 7.7%. Non-inferiority can only be shown with CI.|Risk Difference (Percentage)|1.9||||0.1339||95.0|-0.6|4.4||p-value is for superiority testing|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||4.4|-0.6|0.1339
71055353|NCT00168818|141614734|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.8||||0.3256||95.0|-2.5|0.8|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||0.8|-2.5|0.3256
71055354|NCT00168818|141614734|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.4||||0.7052||95.0|-1.5|2.2|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||2.2|-1.5|0.7052
71055355|NCT00168818|141614735|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-1.1||||0.1863||95.0|-2.7|0.5|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||0.5|-2.7|0.1863
71022146|NCT02191579|141552111|SUPERIORITY||Mean Difference (Net)|-6.199|||<|0.001|TWO_SIDED|95.0|-7.936|-4.462||Estimated mean difference, 95% CI, and p-value were assessed using analysis of covariance adjusting for baseline headache days.|ANCOVA|||||-4.462|-7.936|<0.001
71022147|NCT02191579|141552112|SUPERIORITY||Median Difference (Net)|-4.248|||<|0.001||95.0|-5.766|-2.731||Estimated mean difference, 95% CI, and p-value for Week 30 were assessed using analysis of covariance adjusting for baseline headache days.|ANCOVA|||||-2.731|-5.766|<0.001
71022148|NCT02191579|141552113|SUPERIORITY||Odds Ratio (OR)|4.05|||<|0.001||95.0|2.014|8.157||Odds ratio, 95% CI, and p-value for the Week 29-32 interval were estimated using a logistic regression model adjusted by baseline headache days.|Regression, Logistic|||||8.157|2.014|<0.001
71022149|NCT01364259|141552186|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.175|TWO_SIDED||||||Fisher Exact||Our odds ratio is equal to 0\*5/9\*2 because we have a zero cell in the two by two table. Hence the OR = 0.|||||0.175
71055356|NCT00168818|141614735|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.3||||0.702||95.0|-1.4|2.1|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||2.1|-1.4|0.7020
70933306|NCT00683800|141367523|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.56|||<|0.001|TWO_SIDED|95.0|-0.81|-0.3|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Anxiety scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.30|-0.81|<0.001
71055357|NCT00168818|141614736|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-1.1||||0.3173||95.0|-3.3|1.1|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||1.1|-3.3|0.3173
71055358|NCT00168818|141614736|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|1.9||||0.1274||95.0|-0.5|4.3|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||4.3|-0.5|0.1274
71055359|NCT00168818|141614737|SUPERIORITY_OR_OTHER|||||||0.0694||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.0694
71055360|NCT00168818|141614737|SUPERIORITY_OR_OTHER|||||||0.0212||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.0212
71055361|NCT00168818|141614738|SUPERIORITY_OR_OTHER|||||||0.5062||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.5062
71055362|NCT00168818|141614738|SUPERIORITY_OR_OTHER|||||||0.3717||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.3717
71055363|NCT00168818|141614739|SUPERIORITY_OR_OTHER|||||||0.124||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.1240
71055364|NCT00168818|141614739|SUPERIORITY_OR_OTHER|||||||0.2497||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.2497
71055365|NCT00168818|141614741|SUPERIORITY_OR_OTHER|||||||0.4352||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.4352
70933307|NCT00683800|141367523|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.62|||<|0.001|TWO_SIDED|95.0|-0.83|-0.4|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Depression scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.40|-0.83|<0.001
71055366|NCT00168818|141614741|SUPERIORITY_OR_OTHER|||||||0.6037||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.6037
71055367|NCT02309138|141614748|SUPERIORITY||Risk Ratio (RR)|0.903||||0.668|TWO_SIDED|97.5|0.538|1.516||Each co-primary hypothesis was tested at the 2.5% significance level.|Regression, Logistic|In the ITT, logistic regression was used to quantify the probability of large-for-gestational age as a function of the study arm and clinic type.|A relative risk \< 1 represents a benefit in the direction of the IADPSG group, while a value \> 1 represents a benefit towards the CC group.|Co-primary hypotheses #1: women diagnosed using the IADPSG criteria will have lower rates of large-for-gestational age infants compared to those diagnosed using the Carpenter-Coustan criteria.||1.516|0.538|0.668
71055368|NCT02309138|141614748|SUPERIORITY||Risk Ratio (RR)|0.853||||0.853|TWO_SIDED|97.5|0.493|1.475||Each co-primary hypothesis was tested at the 2.5% significance level.|Regression, Logistic|In the ITT, logistic regression was used to quantify the probability of large-for-gestational age as a function of the study arm and clinic type.||"Co-primary hypothesis #2: women classified as no gestational diabetes by the IADPSG criteria will have lower rates of large-for-gestational age infants compared to those classified in the Carpenter-Coustan criteria."||1.475|0.493|0.853
71055369|NCT02309138|141614749|SUPERIORITY||Risk Ratio (RR)|1.046||||0.6669|TWO_SIDED|95.0|0.847|1.291|||Regression, Logistic|||||1.291|0.847|0.6669
71055370|NCT02309138|141614749|SUPERIORITY||Risk Ratio (RR)|1.033||||0.8394|TWO_SIDED|95.0|0.816|1.307|||Regression, Logistic|||||1.307|0.816|0.8394
71055371|NCT02309138|141614750|SUPERIORITY||Risk Ratio (RR)|0.987||||0.9335|TWO_SIDED|95.0|0.74|1.318|||Regression, Logistic|||||1.318|0.740|0.9335
71055372|NCT02309138|141614750|SUPERIORITY||Risk Ratio (RR)|1.022||||0.926|TWO_SIDED|95.0|0.742|1.407|||Regression, Logistic|||||1.407|0.742|0.9260
71055373|NCT02309138|141614751|SUPERIORITY||Risk Ratio (RR)|1.4||||0.0322|TWO_SIDED|95.0|1.027|1.909|||Regression, Logistic|||||1.909|1.027|0.0322
71055374|NCT02309138|141614751|SUPERIORITY||Risk Ratio (RR)|1.233||||0.2643|TWO_SIDED|95.0|0.864|1.76|||Regression, Logistic|||||1.760|0.864|0.2643
71055375|NCT01559389|141614767|SUPERIORITY||Mean Difference (Final Values)|-0.51|STANDARD_DEVIATION|2.5||0.16|TWO_SIDED|95.0|-1.23|0.21||P-values less than 0.05 were considered statistically significant.|t-test, 2 sided|The method was a paired t-test||The null hypothesis is that there is no difference in the overall GRISS score between females with UUI and their male partners||0.21|-1.23|.16
71055376|NCT01559389|141614768|SUPERIORITY||z-score|2.97||||0.003|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Exact test|The z-score is a standardized Wilcoxon statistic. In this study, z-scores with an absolute value exceeding 1.96 indicate a significant difference in the GRISS change score between responders and non-responders of solifenacin treatment|The null hypothesis is that there is no difference in the overall GRISS change score between those who respond and do not respond to treatment with solifenacin.||||.003
71055377|NCT01559389|141614769|SUPERIORITY||z-score|0.89||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The z-score is a standardized Wilcoxon statistic. In this study, z-scores with an absolute value exceeding 1.96 indicate a significant difference in the GRISS change score between the two groups|The null hypothesis is that there is no difference in the overall GRISS change score between male partners of female participants who respond to solifenacin and male partners of female participants who do not respond to solifenacin||||.37
71055378|NCT01346293|141614770|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% Confidence intervals (CIs) of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for Anti-Pertussis toxoid antigen between groups were \> -10%.|Mean Difference (Final Values)|5.4|||||TWO_SIDED|95.0|0.7|10.2||||||Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.||10.2|0.7|
70933308|NCT00683800|141367523|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.08||||0.082|TWO_SIDED|95.0|-0.17|0.01|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Sexual Dysfunction scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||0.01|-0.17|0.082
71022150|NCT02046369|141552215|SUPERIORITY|The primary efficacy endpoint (the change from baseline in CDRS-R total score at Week 6)will be analyzed using a likelihood-based mixed model for repeated measures (MMRM).The response (dependent) variable is the change from baseline in CDRS-R total score assessed weekly (Weeks 1 to 6).The MMRM model includes fixed effects terms for treatment, visit (as a categorical variable), pooled country, age stratum (stratification factor, CDRS-R total score at baseline, and treatment-by-visit interaction.|LS mean differnce (SE)|-5.7|STANDARD_ERROR_OF_MEAN|1.39|<|0.0001|TWO_SIDED|95.0|-8.4|-3.0|||LS mean differnece (SE)|||A mean difference in change from Baseline in CDRS-R total score of 5.0 units was assumed for the lurasidone 20-80 mg/day arm over the placebo arm, and a common standard deviation of 14.2 units (effect size=0.35), a sample size of 145 subjects per treatment arm was calculated to yield a power of 85%. With an expected attrition rate of 15%, approximately 170 subjects per treatment arm (340 in total) were to be randomized in a 1:1 ratio .||-3.0|-8.4|<0.0001
71022151|NCT02046369|141552216|SUPERIORITY||LS mean differnce (SE)|-1.1|STANDARD_ERROR_OF_MEAN|0.54||0.0385|TWO_SIDED|95.0|-2.2|-0.1|||LS mean differnece (SE)|||LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||-0.1|-2.2|0.0385
71055379|NCT01346293|141614770|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for Anti-Filamentous Haemagglutinin between groups were \> -10%.|Mean Difference (Final Values)|7.4|||||TWO_SIDED|95.0|2.5|21.5||||||Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.||21.5|2.5|
71055380|NCT01346293|141614770|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for the Pertactin antigens between groups were \> -10%.|Mean Difference (Final Values)|3.7|||||TWO_SIDED|3.7|-0.2|7.9||||||Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.||7.9|-0.2|
71055381|NCT01346293|141614770|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for Fimbriae types 2 and 3 antigens between groups were \> -10%.|Mean Difference (Final Values)|4.8|||||TWO_SIDED|95.0|0.9|9.1||||||Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.||9.1|0.9|
71055382|NCT01346293|141614771|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL®) in post-vaccination GMCs for the Pertussis Toxoid antigens between groups were \> 2/3.|Mean Difference (Final Values)|1.97|||||TWO_SIDED|95.0|1.68|2.31||||||Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each Pertussis antigen and their 2-sided 95% Confidence Intervals.||2.31|1.68|
71055383|NCT01346293|141614771|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL®) in post-vaccination GMCs for the Filamentous Haemagglutinin antigens between groups were \> 2/3.|Mean Difference (Final Values)|1.56|||||TWO_SIDED|95.0|1.3|1.88||||||Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each pertussis antigen and their 2-sided 95% Confidence Intervals.||1.88|1.30|
71055384|NCT01346293|141614771|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL®) in post-vaccination GMCs for the Pertactin antigens between groups were \> 2/3.|Mean Difference (Final Values)|1.51|||||TWO_SIDED|95.0|1.27|1.79||||||Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each pertussis antigen and their 2-sided 95% Confidence Intervals.||1.79|1.27|
70941653|NCT04748445|141383934|OTHER||Slope|-2.18|STANDARD_ERROR_OF_MEAN|1.894||0.2519|TWO_SIDED|90.0|-5.319|9.585|||Mixed Models Analysis|||MM\_MFCC mean 02 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit, estimated value and dispersion value it was 10\^-1. For upper limit it was 10\^-2).||9.585|-5.319|0.2519
71055385|NCT01346293|141614771|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL® ) in post-vaccination GMCs for the Fimbriae types 2 and 3 antigens between groups were \> 2/3.|Mean Difference (Final Values)|1.33|||||TWO_SIDED|95.0|1.12|1.6||||||Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each pertussis antigen and their 2-sided 95% Confidence Intervals.||1.60|1.12|
71055386|NCT01798316|141614816|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
71055387|NCT04693416|141614824|OTHER|||||||0.252|||||||t-test, 2 sided|||Pre/post scores within arm||||0.252
71055388|NCT04693416|141614825|OTHER|||||||0.546|||||||t-test, 2 sided|||Pre/post score within arm||||0.546
71055389|NCT04693416|141614826|OTHER|||||||0.005|||||||t-test, 2 sided|||Pre/post scores within arm||||0.005
71055390|NCT04693416|141614827|OTHER|||||||0.188|||||||t-test, 2 sided|||Pre/post scores within arm||||0.188
71055391|NCT04693416|141614828|OTHER|||||||0.049|||||||t-test, 2 sided|||Pre/post score within arm||||0.049
71055392|NCT04693416|141614829|OTHER|||||||0.036|||||||t-test, 2 sided|||Pre/post scores within arm||||0.036
71055393|NCT00474266|141614831|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥-10%.|Difference in percentage|2.2|||||TWO_SIDED|95.0|0.29|6.78||||||||6.78|0.29|
71055394|NCT00474266|141614831|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥ -10%|Difference in percentage|0.28|||||TWO_SIDED|95.0|-0.78|1.58||||||||1.58|-0.78|
70933309|NCT00683800|141367523|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.18|||<|0.001|TWO_SIDED|95.0|-1.61|-0.75|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Psychological scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.75|-1.61|<0.001
70933310|NCT00683800|141367523|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.02||||0.865|TWO_SIDED|95.0|-0.25|0.21|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Somatic scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||0.21|-0.25|0.865
70933311|NCT00683800|141367523|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.45|||<|0.001|TWO_SIDED|95.0|-0.61|-0.29|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Vasomotor scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.29|-0.61|<0.001
70933312|NCT00683800|141367524|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
70933313|NCT00683800|141367525|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
70933314|NCT00683800|141367526|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
71022152|NCT02046369|141552217|SUPERIORITY||LS mean differnce (SE)|3.9|STANDARD_ERROR_OF_MEAN|1.35||0.0044|TWO_SIDED|95.0|1.2|6.5|||LS mean differnece (SE)|||LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||6.5|1.2|0.0044
71022153|NCT02046369|141552218|SUPERIORITY||LS mean differnce (SE)|4.7|STANDARD_ERROR_OF_MEAN|1.19|<|0.0001|TWO_SIDED|95.0|2.4|7.0|||LS mean differnece (SE)|||LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||7.0|2.4|<0.0001
71022154|NCT02046369|141552219|SUPERIORITY||LS mean differnce (SE)|-0.7|STANDARD_ERROR_OF_MEAN|0.77||0.3715|TWO_SIDED|95.0|-2.2|0.8|||ANCOVA|||LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||0.8|-2.2|0.3715
71022155|NCT02046369|141552220|SUPERIORITY||LS mean differnce (SE)|-0.44|STANDARD_ERROR_OF_MEAN|0.112|<|0.0001|TWO_SIDED|95.0|-0.66|-0.22||LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).|LS mean differnece (SE)|||||-0.22|-0.66|<0.0001
71022156|NCT00420290|141552238|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||0.031 is the upper level of significance|ANCOVA|||Using data from 128 CHD patients, CRP data were highly skewed, and data were log transformed to achieve normality. With 14 pts in each group (total of 28), it was predicted the minimum detectable difference between control and intervention would be 15% (1.22 for control group and 1.00 for the intervention group), with an 80% power and an alpha of 0.05 using t test approach. Thus, planned sample size was 30 to complete the study.||||0.008
71022157|NCT00420290|141552239|SUPERIORITY_OR_OTHER|||||||0.03|||||||ANCOVA|||||||0.03
71022158|NCT00420290|141552240|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71022159|NCT00420290|141552241|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71022160|NCT00420290|141552242|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
70933315|NCT00683800|141367527|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
70933316|NCT00683800|141367528|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
71022161|NCT02092961|141552243|SUPERIORITY_OR_OTHER||Treatment difference|-1.75||||0.022|TWO_SIDED|90.0|-2.75|-0.42||A negative value for change from baseline in OMERACT RAMRIS synovitis score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|6 weeks||-0.42|-2.75|0.022
71022162|NCT02092961|141552243|SUPERIORITY_OR_OTHER||Treatment difference|0.5||||0.402|TWO_SIDED|90.0|-1.0|2.0||A negative value for change from baseline in OMERACT RAMRIS synovitis score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|24 weeks||2.00|-1.00|0.402
70933317|NCT00683800|141367529|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
71055395|NCT00474266|141614831|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥ -10%.|Difference in percentage|0.28|||||TWO_SIDED|95.0|-0.79|1.58||||||||1.58|-0.79|
71055396|NCT00474266|141614831|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥ -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.06|1.07||||||||1.07|-1.06|
71055397|NCT00474266|141614832|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥ -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.06|3.17||||||||3.17|-1.06|
71055398|NCT00474266|141614833|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥-10%.|Difference in percentage|4.06|||||TWO_SIDED|95.0|-2.82|12.46||||||||12.46|-2.82|
71107113|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.91|1.22||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 33F: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.22|0.91|<0.001
70933318|NCT00683800|141367530|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
70933319|NCT00683800|141367531|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
70933320|NCT00683800|141367532|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
70933321|NCT00683800|141367533|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
70933322|NCT00683800|141367534|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
70933323|NCT00683800|141367535|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
70933324|NCT00683800|141367536|SUPERIORITY_OR_OTHER||Wald Formula|1.11|||||TWO_SIDED|90.0|-0.68|2.9|||||The 90% CI for excess risk is obtained using the Wald Formula.|Excess risk over placebo of DVS SR 100 mg per 1000 woman-years of exposure, defined as the difference in the exposure adjusted rates between the treatment groups, was obtained.||2.9|-0.68|
70933325|NCT00683800|141367538|SUPERIORITY_OR_OTHER||Wald Formula|2.31|||||TWO_SIDED|90.0|-2.08|6.71|||||The 90% CI for excess risk is obtained using the Wald Formula.|Excess risk over placebo of DVS SR 100 mg per 1000 woman-years of exposure, defined as the difference in the exposure adjusted rates between the treatment groups, was obtained.||6.71|-2.08|
71022163|NCT02092961|141552244|SUPERIORITY_OR_OTHER||Treatment difference|0.0||||0.746|TWO_SIDED|90.0|-1.0|0.5||A negative value for change from baseline in OMERACT RAMRIS osteitis score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|6 weeks||0.50|-1.00|0.746
71022164|NCT02092961|141552244|SUPERIORITY_OR_OTHER||Treatment difference|1.0||||0.413|TWO_SIDED|90.0|-1.5|3.5||A negative value for change from baseline in OMERACT RAMRIS synovitis score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|24 weeks||3.50|-1.50|0.413
71022165|NCT02092961|141552245|SUPERIORITY_OR_OTHER||Treatment difference|0.0||||0.491|TWO_SIDED|90.0|0.0|0.0||A negative value for change from baseline in JSN score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|6 weeks||0.00|0.00|0.491
70933326|NCT00683800|141367539|SUPERIORITY_OR_OTHER||Wald Formula|0.08|||||TWO_SIDED|90.0|-3.51|3.67|||||The 90% CI for excess risk is obtained using the Wald Formula.|Excess risk over placebo of DVS SR 100 mg per 1000 woman-years of exposure, defined as the difference in the exposure adjusted rates between the treatment groups, was obtained.||3.67|-3.51|
70933327|NCT00229970|141367540|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09||||0.022||95.0|0.01|0.16|||ANCOVA|The model included a factor for treatment and using the baseline Forced Expiratory Volume in One Second (FEV1) as a covariate.||||0.16|0.01|0.022
70933328|NCT00229970|141367540|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17|||<|0.001||95.0|0.09|0.24|||ANCOVA|The model included a factor for treatment and using the baseline Forced Expiratory Volume in One Second (FEV1) as a covariate.||||0.24|0.09|<0.001
70933329|NCT01700205|141367541|OTHER|A priori power analyses determined that a sample size of 94 is required to detect a difference of 0.67 with 90% power and a 5% type 1 error rate. We conducted an intention-to-treat (ITT) analyses on the 113 infants using separate generalized estimating equations that included treatment group (CMF, EHF), time (infant age), and group × time interaction for each type of Z score (0.5-12.5 mos).|Slope|-0.018|||<|0.05|TWO_SIDED|95.0|-0.0363|-0.0002|||Generalized Estimating Equation|GEE analysis conducted with group (CMF, EHF), time (infant age, 0.5-12.5 months) and their interaction.||||-0.0002|-0.0363|<0.05
70933330|NCT01700205|141367542|OTHER|A priori power analyses determined that a sample size of 94 is required to detect a difference of 0.67 with 90% power and a 5% type 1 error rate. We conducted an intention-to-treat (ITT) analyses on the 113 infants using separate generalized estimating equations that included treatment group (CMF, EHF), time (infant age), and group × time interaction for each type of Z score (0.5-12.5 mos). We provide below the parameter estimates for WLZ scores only.|Slope|-0.023||||0.001|TWO_SIDED|95.0|-0.0362|-0.0093|||Generalized Estimating Equations|GEE analysis conducted on each type of Z score separately with group (CMF, EHF), time (infant age; 0.5-12.5 months) and their interaction.||||-0.0093|-0.0362|0.001
71055399|NCT00474266|141614834|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥ -10%|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.06|3.18||||||||3.18|-1.06|
70851409|NCT02191865|141190611|SUPERIORITY_OR_OTHER||Ratio of geometric means|870.74|STANDARD_DEVIATION|45.7|||TWO_SIDED|90.0|576.36|1315.49|||ANOVA|Fixed effect: 'hepatic status'; indicated whether a subject with hepatic impairment or a healthy subject , Random effect: 'matched pair'.|Ratio of Child Pugh B (Test): Healthy Child Pugh B (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of AUC (0-tz) was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.||1315.49|576.36|
70851410|NCT04693234|141190613|SUPERIORITY|||||||0.0054|||||||Binomial Exact Test|The p-value was calculated from the binomial exact test of tislelizumab combined with ociperlimab versus historical rate of 0.15.||||||0.0054
70851411|NCT04693234|141190614|SUPERIORITY|||||||0.0127|||||||Binomial Exact Test|The p-value was calculated from the binomial exact test of tislelizumab combined with ociperlimab versus historical rate of 0.15.||||||0.0127
71055400|NCT00474266|141614835|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥-10%.|Difference in percentage|3.36|||||TWO_SIDED|95.0|-0.28|9.5||||||||9.5|-0.28|
71055401|NCT01695863|141614858|SUPERIORITY||Mean Difference (Final Values)|0.54|||<|0.0001|TWO_SIDED|95.0|0.269|0.816|||t-test, 2 sided|||Right Colon||0.816|0.269|<0.0001
71055402|NCT01695863|141614858|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.005|TWO_SIDED|95.0|0.122|0.655|||t-test, 2 sided|||Transverse Colon||0.655|0.122|0.005
71055403|NCT01695863|141614858|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.08|TWO_SIDED|95.0|-0.029|0.484|||t-test, 2 sided|||Left Colon||0.484|-0.029|0.08
71055404|NCT01695863|141614859|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.093|TWO_SIDED||||||t-test, 2 sided|||Calcium||||0.093
71055405|NCT01695863|141614859|SUPERIORITY||Mean Difference (Final Values)|2.03||||0.801|TWO_SIDED||||||t-test, 2 sided|||Glucose||||0.801
71055406|NCT01695863|141614859|SUPERIORITY||Mean Difference (Final Values)|-0.44||||0.599|TWO_SIDED||||||t-test, 2 sided|||Blood Urea Nitrogen||||0.599
71055407|NCT01695863|141614859|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.696|TWO_SIDED||||||t-test, 2 sided|||Creatinine||||0.696
71055408|NCT01695863|141614859|SUPERIORITY||Mean Difference (Final Values)|-1.19||||0.042|TWO_SIDED||||||t-test, 2 sided|||Sodium||||.042
71055409|NCT01695863|141614859|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.596|TWO_SIDED||||||t-test, 2 sided|||Potassium||||0.596
71055410|NCT01695863|141614859|SUPERIORITY||Mean Difference (Final Values)|-0.98||||0.107|TWO_SIDED||||||t-test, 2 sided|||Chloride||||0.107
71055411|NCT01695863|141614859|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.351|TWO_SIDED||||||t-test, 2 sided|||Bicarbonate||||0.351
71055412|NCT01695863|141614860|SUPERIORITY||Mean Difference (Final Values)|-0.0438||||0.772|TWO_SIDED||||||t-test, 2 sided|||Nausea||||0.772
71055413|NCT01695863|141614860|SUPERIORITY||Mean Difference (Final Values)|-0.2821||||0.028|TWO_SIDED||||||t-test, 2 sided|||Vomiting||||0.028
71055414|NCT01695863|141614860|SUPERIORITY||Mean Difference (Final Values)|-0.2102||||0.235|TWO_SIDED||||||t-test, 2 sided|||Bloating||||0.235
71055415|NCT01695863|141614860|SUPERIORITY||Mean Difference (Final Values)|-0.0547||||0.707|TWO_SIDED||||||t-test, 2 sided|||Abdominal pain or cramping||||0.707
71055416|NCT01695863|141614860|SUPERIORITY||Mean Difference (Final Values)|-0.0269||||0.773|TWO_SIDED||||||t-test, 2 sided|||Ability to complete entire prep||||0.773
71055417|NCT01695863|141614860|SUPERIORITY||Mean Difference (Final Values)|0.0498||||0.766|TWO_SIDED||||||t-test, 2 sided|||Difficulty/Inconvenience in completing prep||||0.766
71055418|NCT03095638|141614867|OTHER||Ratio|1.0084|||||TWO_SIDED|90.0|0.8626|1.1789||||||||1.1789|0.8626|
71055419|NCT03095638|141614868|OTHER||Ratio|1.0121|||||TWO_SIDED|90.0|0.8648|1.1845||||||||1.1845|0.8648|
71055420|NCT03095638|141614869|OTHER||Ration|1.0329|||||TWO_SIDED|90.0|0.8623|1.2373||||||||1.2373|0.8623|
71055421|NCT03095638|141614870|OTHER||Ratio|1.6242|||||TWO_SIDED|90.0|1.4986|1.7604||||||||1.7604|1.4986|
71055422|NCT03095638|141614870|OTHER||Ratio|1.5448|||||TWO_SIDED|90.0|1.4253|1.6743||||||||1.6743|1.4253|
71055423|NCT03095638|141614871|OTHER||Ratio|1.6292|||||TWO_SIDED|90.0|1.503|1.7661||||||||1.7661|1.5030|
71055424|NCT03095638|141614871|OTHER||Ratio|1.5519|||||TWO_SIDED|90.0|1.4317|1.6822||||||||1.6822|1.4317|
71055425|NCT03095638|141614872|OTHER||Ratio|1.7933|||||TWO_SIDED|90.0|1.6226|1.9819||||||||1.9819|1.6226|
71055426|NCT03095638|141614872|OTHER||Ratio|1.7974|||||TWO_SIDED|90.0|1.6263|1.9865||||||||1.9865|1.6263|
71055427|NCT04080544|141614942|OTHER|Null-hypothesis significance testing|Slope|-1.42|STANDARD_ERROR_OF_MEAN|0.81||0.081|TWO_SIDED|95.0|-3.03|0.18||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to episodic memory.||0.18|-3.03|.081
71055428|NCT04080544|141614942|OTHER|Null-hypothesis significance test|Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.13||0.604|TWO_SIDED|95.0|-0.32|0.19||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the interaction of temporal tau SUVR and amyloid SUVR in prediction of episodic memory.||0.19|-0.32|.604
71022166|NCT02092961|141552245|SUPERIORITY_OR_OTHER||Treatment difference|0.0||||0.341|TWO_SIDED|90.0|0.0|0.0||A negative value for change from baseline in JSN score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|24 weeks||0.00|0.00|0.341
71022167|NCT02092961|141552246|SUPERIORITY_OR_OTHER||Treatment difference|0.0||||0.366|TWO_SIDED|90.0|-0.5|0.0||A negative value for change from baseline in OMERACT RAMRIS erosions score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|6 weeks||0.00|-0.50|0.366
71022168|NCT02092961|141552246|SUPERIORITY_OR_OTHER||Treatment difference|1.25||||0.053|TWO_SIDED|90.0|0.5|2.5||A negative value for change from baseline in OMERACT RAMRIS erosions score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|24 weeks||2.50|0.50|0.053
71022169|NCT02092961|141552247|SUPERIORITY_OR_OTHER||Least Square Mean Treatment Difference|0.89||||0.006|TWO_SIDED|90.0|0.36|1.41|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and DMARD naivety (DMARD naive vs DMARD-IR/intolerant) as factors.||Change from baseline at Week 6. Nonresponder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data. Patients who prematurely withdrew due to project closure have no imputation applied.||1.41|0.36|0.006
71107114|NCT03950856|141720646|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.9|1.22||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 33F: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.22|0.90|<0.001
70933331|NCT01700205|141367543|OTHER|A priori power analyses determined that a sample size of 94 is required to detect a difference of 0.67 with 90% power and a 5% type 1 error rate. We conducted an intention-to-treat (ITT) analyses on the 113 infants using separate generalized estimating equations that included treatment group (CMF, EHF), time (infant age), and group × time interaction for each type of Z score (0.5-12.5 mos).|Slope|-0.02||||0.32|TWO_SIDED|95.0|-0.058|0.019|||Generalized Estimating Equation|GEE analysis conducted with group (CMF, EHF), time (infant age, 0.5-12.5 months) and their interaction||||0.019|-0.058|0.32
70933332|NCT01700205|141367544|OTHER|ANOVA with group (CMF, EHF) as between-subjects factor were conducted on intent-to-treat sample|||||<|0.05|||||||Repeated Measures ANOVA|We conducted a ANOVA with group (CMF, EHF) as between-subject factor.||ANOVAs were conducted with group (CMF, EHF) as the between-subjects factor.||||<0.05
70933333|NCT01700205|141367545|OTHER|ANOVA was conducted with group (CMF, EHF) as between-subjects factor on the intent-to-treat sample.||||||0.72|||||||Repeated Measure ANOVA|ANOVA was conducted with group (CMF, EHF) as between-subjects factor on the intent-to-treat sample.||Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor||||0.72
70933334|NCT01700205|141367546|OTHER|Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample||||||0.72|||||||Repeated Measure ANOVA|Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample||Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample||||0.72
71107115|NCT03950856|141720647|OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.84|1.1|||||Lot 1 divided by Lot 2|Serotype 1: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.10|0.84|
71107116|NCT03950856|141720647|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.89|1.17|||||Lot 1 divided by Lot 3|Serotype 1: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.17|0.89|
70851412|NCT04643158|141190634|SUPERIORITY||Least Square Mean Difference|0.0236||||0.828|TWO_SIDED|95.0|-0.1934|0.2406|||Mixed Models Analysis|||||0.2406|-0.1934|0.828
70851413|NCT04643158|141190634|SUPERIORITY||Least Square Mean Difference|0.196||||0.035|TWO_SIDED|95.0|0.0143|0.3778|||Mixed Models Analysis|||||0.3778|0.0143|0.035
70933335|NCT01700205|141367547|OTHER|Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample||||||0.02|||||||Repeated Measure ANOVA|Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample||Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample||||0.02
70933336|NCT03758742|141367568|SUPERIORITY||||||<|0.0001|||||||Binomial Test|||||||<0.0001
70933337|NCT03229408|141367602|SUPERIORITY||||||<|0.004|||||||Unpaired t-test, 2-Sided|||||||<0.004
70933338|NCT03229408|141367603|SUPERIORITY||||||<|0.03|||||||Unpaired T-test, 2-Sided|||||||<0.03
70933339|NCT03229408|141367604|SUPERIORITY|||||||0.18|||||||Unpaired t-test, 2-Sided|||||||0.180
70933340|NCT03229408|141367605|SUPERIORITY||||||<|0.002|||||||Unpaired T-test, 2-Sided|||||||<0.002
70933341|NCT03229408|141367606|SUPERIORITY||||||<|0.04|||||||Unpaired t-test, 2-Sided|||||||<0.04
70933342|NCT03229408|141367607|SUPERIORITY||||||<|0.003|||||||Unpaired t-test, 2-Sided|||||||<0.003
70933343|NCT03229408|141367608|SUPERIORITY||||||<|0.0004|||||||Unpaired t-test, 2-Sided|||||||<0.0004
70933344|NCT03229408|141367609|SUPERIORITY||||||<|0.007|||||||Unpaired t-test, 2-Sided|||||||<0.007
71022170|NCT02092961|141552247|SUPERIORITY_OR_OTHER||Least Square Mean Treatment Difference|-0.34||||0.496|TWO_SIDED|90.0|-1.16|0.49|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and DMARD naivety (DMARD naive vs DMARD-IR/intolerant) as factors.||Change from baseline at Week 24. Nonresponder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data. Patients who prematurely withdrew due to project closure have no imputation applied.||0.49|-1.16|0.496
71022171|NCT01928446|141552275|SUPERIORITY||Cox Proportional Hazard|1.1||||0.61|TWO_SIDED|95.0|0.77|1.55|||Log Rank|||Model1 - Treatment only: unadjusted for other covariates||1.55|0.77|0.61
71022172|NCT01928446|141552275|SUPERIORITY||Cox Proportional Hazard|1.08||||0.67|TWO_SIDED|95.0|0.76|1.53|||Log Rank|||Model2 - Treatment only: unadjusted with Site as random Effect||1.53|0.76|0.67
71022173|NCT01928446|141552276|SUPERIORITY||Cox Proportional Hazard|1.49||||0.37|TWO_SIDED|95.0|0.61|3.64|||Log Rank|||||3.64|0.61|0.37
71022174|NCT01928446|141552277|SUPERIORITY||Cox Proportional Hazard|1.14||||0.77|TWO_SIDED|95.0|0.48|2.69|||Log Rank|||Model 5: Non-fatal self-directed violence subgroup||2.69|0.48|0.77
71022175|NCT01928446|141552277|SUPERIORITY||Cox Proportional Hazard|1.61||||0.22|TWO_SIDED|95.0|0.75|3.43|||Log Rank|||Model 6: Interrupted self-directed violence subgroup||3.43|0.75|0.22
71022176|NCT01928446|141552277|SUPERIORITY||Cox Proportional Hazard|0.92||||0.71|TWO_SIDED|95.0|0.58|1.45|||Log Rank|||Model 7: Hospitalization to prevent suicide||1.45|0.58|0.71
71022177|NCT00740727|141552280|SUPERIORITY_OR_OTHER||% of subjects with infusion pain|11.1||||||95.0|1.4|34.7|||95% binomial exact confidence interval|||This analysis reports the number of subjects (of 18 possible) who experienced pain, during EASI placement or infusion, at the a priori-defined level of at least 3 on a 10-point pain scale.||34.7|1.4|
71022178|NCT00740727|141552281|SUPERIORITY_OR_OTHER||% subjects with next-day EASI site pain|0.0||||||97.5|0.0|18.5|||binomial exact confidence interval|Because the point estimate was zero, the statistical software (STATA version 10MP) reports a one-sided 97.5% confidence interval.||This analysis reports the number of subjects (of 18 possible) who experienced pain, as assessed on next-day follow-up (24 hours after EASI infusion), at the a priori-defined level of at least 3 on a 10-point pain scale.||18.5|0|
71022179|NCT04364165|141552282|SUPERIORITY||Odds Ratio (OR)|2.0||||0.01|TWO_SIDED|95.0|1.44|2.78|||Regression, Logistic|||||2.78|1.44|.01
71022180|NCT04364165|141552283|SUPERIORITY||Odds Ratio (OR)|1.44||||0.41|TWO_SIDED|95.0|0.36|5.78|||Regression, Logistic|||||5.78|0.36|.41
71022181|NCT01042977|141552342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.0489|<|0.0001|TWO_SIDED|95.0|-0.5|-0.3||Significant at alpha=0.025 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|ANCOVA|with treatment group and stratum as effects and baseline value as covariate for each endpoint|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.30|-0.50|<0.0001
71022182|NCT01042977|141552343|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.0|||<|0.0001|TWO_SIDED|95.0|4.3|9.8||Significant at alpha=0.025 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|Cochran-Mantel-Haenszel|with age-by-insulin use-by-time from most recent qualifying CV event as stratum||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||9.8|4.3|<0.0001
71022183|NCT01042977|141552344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|0.1957|<|0.0001|TWO_SIDED|95.0|-2.31|-1.54||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.54|-2.31|<0.0001
71055429|NCT04080544|141614943|OTHER|Null-hypothesis significance test|Slope|1.77|STANDARD_ERROR_OF_MEAN|0.81||0.033|TWO_SIDED|95.0|0.15|3.39||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for baseline age, sex, and years of education.||Regression testing the relationship between amyloid accumulation (annualized change score for amyloid SUVR) to temporal tau SUVR.||3.39|0.15|.033
71055430|NCT04080544|141614944|OTHER|Null-hypothesis significance testing|Slope|0.272|STANDARD_ERROR_OF_MEAN|0.7||0.699|TWO_SIDED|95.0|-1.12|1.66||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to speed of processing.||1.66|-1.12|.699
70851414|NCT04643158|141190654|SUPERIORITY||Geometric Least Square Mean Ratio|-38.31||||0.202|TWO_SIDED|95.0|-71.11|31.72|||Mixed Models Analysis||Analyses were done on the natural log scale and the results were back-transformed to linear scale.|||31.72|-71.11|0.202
71055431|NCT04080544|141614944|OTHER|Null-hypothesis significance test|Slope|0.16|STANDARD_ERROR_OF_MEAN|0.11||0.154|TWO_SIDED|95.0|-0.06|0.38||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the interaction of temporal tau SUVR and amyloid SUVR in the prediction of speed of processing.||0.38|-0.06|.154
71055432|NCT04080544|141614945|OTHER|Null-hypothesis significance testing|Slope|-1.11|STANDARD_ERROR_OF_MEAN|0.74||0.137|TWO_SIDED|95.0|-2.58|0.36||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to reasoning function.||0.36|-2.58|.137
71022184|NCT01042977|141552345|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.6|STANDARD_ERROR_OF_MEAN|2.149|<|0.0001|TWO_SIDED|95.0|9.4|17.8||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline total body weight and age stratum||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||17.8|9.4|<0.0001
71055433|NCT04080544|141614945|OTHER|Null-hypothesis significance test|Slope|0.11|STANDARD_ERROR_OF_MEAN|0.13||0.428|TWO_SIDED|95.0|-0.16|0.37||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the interaction of temporal tau SUVR and amyloid SUVR in prediction of reasoning.||0.37|-0.16|.428
70851415|NCT04643158|141190654|SUPERIORITY||Geometric Least Square Mean Ratio|-15.43||||0.596|TWO_SIDED|95.0|-55.57|60.96|||Mixed Models Analysis||Analyses were done on the natural log scale and the results were back-transformed to linear scale.|||60.96|-55.57|0.596
70933345|NCT04200664|141367617|OTHER|Kendall tau b correlation analysis test was performed between the number of cognitive domains affected and the both ears 3-frequency pure tone average (at 0.5/1/2kHz) or both ears 4-frequency pure tone average (at 0.5/1/2/4kHz).|Kendall Tau-b|0.462||||0.176|TWO_SIDED||||||Kendall tau-b|Kendall tau b non-parametric correlation analysis was performed.||||||0.176
70933346|NCT00291694|141367647|SUPERIORITY_OR_OTHER|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||||||0.71
70933347|NCT00291694|141367648|SUPERIORITY_OR_OTHER|||||||0.053||||||Not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||Difference between groups, two-sided. Endpoint not specifically powered for effect.||||0.053
70933348|NCT00291694|141367649|SUPERIORITY_OR_OTHER|||||||0.37||||||Not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||0.37
70933349|NCT00291694|141367650|SUPERIORITY_OR_OTHER|||||||0.39||||||Not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||0.39
70933350|NCT00291694|141367651|SUPERIORITY_OR_OTHER|||||||0.37||||||Not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||0.37
71022185|NCT01042977|141552346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.71|STANDARD_ERROR_OF_MEAN|0.7977||0.0007|TWO_SIDED|95.0|-4.28|-1.15||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.15|-4.28|0.0007
71022186|NCT01042977|141552347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.02|STANDARD_ERROR_OF_MEAN|0.7983||0.0002|TWO_SIDED|95.0|-4.59|-1.46||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.46|-4.59|0.0002
71107117|NCT03950856|141720647|OTHER||GMC Ratio|1.06|||||TWO_SIDED|95.0|0.92|1.21|||||Lot 2 divided by Lot 3|Serotype 1: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.21|0.92|
70933351|NCT01706159|141367665|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.16||||0.3056||90.0|0.01|3.05||p-value was not adjusted for multiple comparisons.|Regression, Logistic|||A sample size of 90 subjects, with a 2:1 (active:placebo) randomization ratio, would ensure 80% power to detect a difference between active treatment and placebo at Week 8 with a 2-sided significance level of 10% based on a Fisher's exact test.||3.05|0.01|0.3056
70933352|NCT03775486|141367689|OTHER||Hazard Ratio (HR)|0.76||||0.074|TWO_SIDED|95.0|0.57|1.02|||Log Rank|||||1.02|0.57|0.074
70933353|NCT03775486|141367689|OTHER||Median|7.2|||||TWO_SIDED|95.0|5.3|7.9||||||Median progression-free survival (months)||7.9|5.3|
70933354|NCT03775486|141367689|OTHER||Median|5.3|||||TWO_SIDED|95.0|3.7|5.8||||||Median progression-free survival (months)||5.8|3.7|
70933355|NCT03775486|141367690|OTHER||Hazard Ratio (HR)|0.9||||0.604|TWO_SIDED|95.0|0.59|1.36|||Log Rank|||||1.36|0.59|0.604
70933356|NCT03775486|141367690|OTHER||Median|17.4|||||TWO_SIDED|95.0|14.1||NA = insufficient number of participants with events|||||Median overall survival (months)|||14.1|
70933357|NCT03775486|141367690|OTHER||Median overall survival (months)|11.8|||||TWO_SIDED|95.0|11.8||NA = insufficient number of participants with events||||The CI lower limit is included as the estimated value as there was an insufficient number of participants with events to calculate a median value|Median overall survival (months)|||11.8|
70933358|NCT03775486|141367692|OTHER|Median duration of response (months)|Median duration of response|6.5|||||TWO_SIDED|95.0|6.5||NA = insufficient number of participants with events||||The CI lower limit is included as the estimated value as there was an insufficient number of participants with events to calculate a median value||||6.5|
70933359|NCT03775486|141367692|OTHER|Median duration of response (months)|Median duration of response|3.8|||||TWO_SIDED|95.0|3.8||NA = insufficient number of participants with events||||The CI lower limit is included as the estimated value as there was an insufficient number of participants with events to calculate a median value||||3.8|
70933360|NCT03775486|141367693|OTHER||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.07|2.0||||||||2.00|0.07|
70933361|NCT03775486|141367693|OTHER||Median (months)|3.7|||||TWO_SIDED|95.0|1.7||NA = insufficient number of participants with events|||||Median progression-free survival (months)|||1.7|
70933362|NCT03775486|141367693|OTHER||Median (months)|3.7|||||TWO_SIDED|95.0|1.2|16.6||||||Median progression-free survival (months)||16.6|1.2|
70933363|NCT03775486|141367695|OTHER||Estimated difference in adjusted mean|-0.51|||||TWO_SIDED|95.0|-4.47|3.46||||||EORTC QLQ-LC13: Dyspnoea Estimated difference in adjusted mean change from baseline.||3.46|-4.47|
70933364|NCT03775486|141367695|OTHER||Estimated difference in adjusted mean|0.95|||||TWO_SIDED|95.0|-4.81|6.71||||||EORTC QLQ-LC13: Coughing Estimated difference in adjusted mean change from baseline.||6.71|-4.81|
70933365|NCT03775486|141367695|OTHER||Estimated difference in adjusted mean|-2.26|||||TWO_SIDED|95.0|-6.39|1.88||||||EORTC QLQ-LC13: Pain in chest Estimated difference in adjusted mean change from baseline.||1.88|-6.39|
70933366|NCT03775486|141367697|OTHER||Estimated difference in adjusted mean|1.64|||||TWO_SIDED|95.0|-2.2|5.47||||||EORTC QLQ-C30: Fatigue Estimated difference in adjusted mean change from baseline.||5.47|-2.20|
70933367|NCT03775486|141367697|OTHER||Estimated difference in adjusted mean|3.22|||||TWO_SIDED|95.0|-1.46|7.9||||||EORTC QLQ-C30: Appetite loss Estimated difference in adjusted mean change from baseline.||7.90|-1.46|
70933368|NCT05256797|141367755|SUPERIORITY||Cox Proportional Hazard|0.69|||||TWO_SIDED|95.0|0.66|0.71||||||Hazard ratio||0.71|0.66|
70933369|NCT04172675|141367816|SUPERIORITY||Hazard Ratio (HR)|0.28|||=|0.0007|TWO_SIDED|95.0|0.13|0.61|||Unstratified Log rank||Hazard ratio and 95% CI were estimated using a Cox proportional hazards regression model.|||0.61|0.13|=0.0007
70933370|NCT05349721|141367831|OTHER||Treatment Difference|6.86||||0.516|TWO_SIDED|95.0|-13.86|27.59|||ANCOVA|Estimates were derived from the ANCOVA model (following multiple imputation), where participant ranks served as the response variable.||||27.59|-13.86|0.516
70933371|NCT03070392|141367845|SUPERIORITY||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.37|0.71|||Log Rank|||||0.71|0.37|<0.0001
71022187|NCT01042977|141552348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|0.9746||0.0004|TWO_SIDED|95.0|-5.35|-1.53||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.53|-5.35|0.0004
71022188|NCT04356573|141552356|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
71022189|NCT01577537|141552359|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71022190|NCT02008721|141552373|SUPERIORITY|||||||0.51|||||||Mixed Models Analysis|||"Power calculation: 80% power, 5% P-level, 50% effect size, i.e. an expected mean yearly UMSARS-ME increase of 3,9 under verum treatment compared to 7.8 ± 6.8 (mean ± standard deviation) under Placebo treatment.~We used a linear mixed-effects model to test the primary hypothesis-ie, to compare differences in the change in motor examination scores on UMSARS between baseline and week 52 between the study groups."||||0.51
71022191|NCT02008721|141552374|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||"Power calculation: 80% power, 5% P-level, 50% effect size, i.e. an expected mean yearly UMSARS-ME increase of 3,9 under verum treatment compared to 7.8 ± 6.8 (mean ± standard deviation) under Placebo treatment.~We used a linear mixed-effects model to test the primary hypothesis-ie, to compare differences in the change in motor examination scores on UMSARS between baseline and week 52 between the study groups."||||0.82
71022192|NCT02008721|141552375|SUPERIORITY|||||||0.99|||||||Mixed Models Analysis|||"Power calculation: 80% power, 5% P-level, 50% effect size. We used a linear mixed-effects model to test the primary hypothesis-ie, to compare differences in the change in UMSARS total score between baseline and week 52 between the study groups.~We did a post-hoc power calculation based on the mean change in motor examination scores on UMSARS and SDs in the placebo group of the per-protocol study completer set to test the assumptions of our initial power calculation."||||0.99
71055434|NCT04080544|141614946|OTHER|Null-hypothesis significance test|Slope|-0.7|STANDARD_ERROR_OF_MEAN|0.78||0.376|TWO_SIDED|95.0|-2.25|0.86||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to working memory.||0.86|-2.25|.376
71055435|NCT04080544|141614946|OTHER|Null-hypothesis significance test|Slope|0.27|STANDARD_ERROR_OF_MEAN|0.13||0.039|TWO_SIDED|95.0|0.01|0.53||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the interaction of temporal tau SUVR and amyloid SUVR in prediction of working memory.||0.53|0.01|.039
71107118|NCT03950856|141720647|OTHER||GMC Ratio|0.85|||||TWO_SIDED|95.0|0.77|0.95|||||Lot 1 divided by Lot 2|Serotype 3: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|0.95|0.77|
71022193|NCT02008721|141552376|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||"Power calculation: 80% power, 5% P-level, 50% effect size. We used a linear mixed-effects model to test the primary hypothesis-ie, to compare differences in the change in UMSARS total score between baseline and week 52 between the study groups.~We did a post-hoc power calculation based on the mean change in motor examination scores on UMSARS and SDs in the placebo group of the per-protocol study completer set to test the assumptions of our initial power calculation."||||0.43
71022194|NCT00711867|141552400|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was defined as -0.5 C.|Mean Difference (Final Values)|-0.34||||||95.0|-0.55|-0.14|||t-test, 2 sided|||H0: Mu\_VH - Mu\_BH \<= -0.5 C.||-0.14|-0.55|
71055436|NCT04080544|141614946|OTHER|Null-hypothesis significance test|Slope|-0.47|STANDARD_ERROR_OF_MEAN|0.27||0.091|TWO_SIDED|||||A priori threshold was two-sided 0.017 after Bonferroni correction for multiple comparisons (3 post hoc tests).|sim_slopes (R interactions package)|||Post hoc simple slopes test of the amyloid x tau interaction (Statistical Analysis #2) at 1SD below the mean for amyloid||||.091
70933372|NCT03070392|141367847|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0139|TWO_SIDED|95.0|0.58|0.94|||Log Rank|||||0.94|0.58|0.0139
71055437|NCT04080544|141614946|OTHER|Null-hypothesis significance test|Slope|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.296|TWO_SIDED|||||A priori threshold was two-sided 0.017 after Bonferroni correction for multiple comparisons (3 post hoc tests).|sim_slopes (R interactions package)|||Post hoc simple slopes test of the amyloid x tau interaction (Statistical Analysis #2) at the mean for amyloid SUVR||||.296
71055438|NCT04080544|141614946|OTHER|Null-hypothesis significance test|Slope|0.07|STANDARD_ERROR_OF_MEAN|0.17||0.695|TWO_SIDED|||||A priori threshold was two-sided 0.017 after Bonferroni correction for multiple comparisons (3 post hoc tests).|sim_slopes (R interactions package)|||Post hoc simple slopes test of the amyloid x tau interaction (Statistical Analysis #2) at 1SD above the mean for amyloid SUVR||||.695
71055439|NCT04080544|141614947|OTHER|Null-hypothesis significance test|Slope|0.002|STANDARD_ERROR_OF_MEAN|0.001||0.012|TWO_SIDED|95.0|0.0004|0.004||A prior threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(linear) to inferior temporal SUVR.||0.004|0.0004|.012
71107119|NCT03950856|141720647|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.91|1.13|||||Lot 1 divided by Lot 3|Serotype 3: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.13|0.91|
71107120|NCT03950856|141720647|OTHER||GMC Ratio|1.18|||||TWO_SIDED|95.0|1.06|1.32|||||Lot 2 divided by Lot 3|Serotype 3: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.32|1.06|
70933373|NCT03861052|141367863|SUPERIORITY||Least Squares Mean Difference|-1.09|||<|0.001|TWO_SIDED|95.0|-1.27|-0.9|||Mixed Models Analysis|||||-0.90|-1.27|<0.001
71022195|NCT04133519|141552401|SUPERIORITY||Odds Ratio (OR)|1.16||||0.5352|TWO_SIDED|95.0|0.73|1.84||P value from Cochran-Mantel-Haenszel testing of H0: OR=1; H1: OR≠1 adjusting for IBS subtype and gender|Cochran-Mantel-Haenszel|||P value from Cochran-Mantel-Haenszel testing of H0: OR=1; H1: OR≠1 adjusting for IBS subtype and gender||1.84|0.73|0.5352
71022196|NCT04133519|141552401|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0232|TWO_SIDED|95.0|1.08|2.87|||Cochran-Mantel-Haenszel||Odds ratio reflects the odds of the number of GDH responders being greater than the number of MR responders for abdominal pain intensity.|The final 4 weeks of the on-treatment period (weeks 9-12) was a pre-specified period for analysis of the primary endpoint measure of abdominal pain due to IBS. An abdominal pain intensity responder was defined as a participant whose daily abdominal pain intensity averaged over the last 4 weeks of phase s (weeks 9 through 12) was at least 30% reduced compared with the daily abdominal pain intensity averaged over the 4 weeks of phase 1.||2.87|1.08|0.0232
71022197|NCT04133519|141552401|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0254|TWO_SIDED|95.0|1.07|2.89||P-value from Cochran-Mantel-Haenszel Test testing H0: OR=1; H1: OR\<\>1 adjusting for IBS subtype and gender|Cochran-Mantel-Haenszel||Odds ratio reflects the odds of GDH being superior to MR.|"Abdominal pain scores were averaged each week on treatment (1-12) and compared with the average baseline abdominal pain score. Participants that recorded a \> 30% decrease in abdominal pain in at least half the weeks on treatment were considered responders.~This analysis was specified in FDA Guidance for Industry, Irritable Bowel Syndrome - Clinical Evaluation of Drugs for Treatment, May 2012. Both the analysis period and the responder threshold (30%) are specified by the FDA Guidance."|Among all subjects, 64.0% reported Adequate Relief and 67.7% reported overall satisfaction with Regulora.|2.89|1.07|0.0254
70851416|NCT03462511|141190706|SUPERIORITY||Mean Difference (Net)|2.4||||0.067|TWO_SIDED|||||Independent variables: study month, study group, their interactions and a person-level random intercept to incorporate clustering.|Regression, Linear|||Based on estimated effect size from our prior feasibility trial, the target enrollment was 87 dyads plus additional 20% to account for attrition before Month 6 or blood transfusions or acute illness rendering HbF levels inaccurate.||||0.067
71022198|NCT04133519|141552402|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.8115|TWO_SIDED|95.0|-0.434|0.554|||ANOVA|||The least square (LS) mean difference between the GDH and MR groups using an analysis of variance (ANOVA) model||0.554|-0.434|0.8115
71055440|NCT04080544|141614947|OTHER|Null-hypothesis significance test|Slope|-0.000005|STANDARD_ERROR_OF_MEAN|0.00004||0.905|TWO_SIDED|95.0|-0.000009|0.00008||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(quadratic) to inferior temporal SUVR.||0.00008|-0.000009|.905
71055441|NCT04080544|141614947|OTHER|Null-hypothesis significance test|Slope|0.002|STANDARD_ERROR_OF_MEAN|0.001||0.006|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(growth model) to inferior temporal SUVR. Growth modeling was performed using SPSS curve estimation.||||.006
71055442|NCT04080544|141614947|OTHER|Null-hypothesis significance test|Slope|0.002|STANDARD_ERROR_OF_MEAN|0.001||0.018|TWO_SIDED|95.0|0.0003|0.003||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(linear) to middle temporal gyrus SUVR.||0.003|0.0003|.018
71055443|NCT04080544|141614947|OTHER|Null-hypothesis significance test|Slope|-0.00002|STANDARD_ERROR_OF_MEAN|0.00004||0.579|TWO_SIDED|95.0|-0.0001|0.00006||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustment for multiple comparisons.||Regression testing the relationship of age(quadratic) to middle temporal SUVR.||0.00006|-0.0001|.579
71055444|NCT04080544|141614947|OTHER|Null-hypothesis significance test|Slope|0.002|STANDARD_ERROR_OF_MEAN|0.001||0.008|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(growth model) to middle temporal SUVR. Growth modeling was performed using SPSS curve estimation.||||.008
71055445|NCT04080544|141614947|OTHER|Null-hypothesis significance test|Slope|0.00006|STANDARD_ERROR_OF_MEAN|0.0004||0.897|TWO_SIDED|95.0|-0.001|0.001||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age to superior temporal SUVR.||0.001|-0.001|.897
71055446|NCT04080544|141614947|OTHER|Null-hypothesis significance test|Slope|-0.00002|STANDARD_ERROR_OF_MEAN|0.00003||0.539|TWO_SIDED|95.0|-0.00007|0.00003||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(quadratic) to superior temporal SUVR.||0.00003|-0.00007|.539
71055447|NCT04080544|141614947|OTHER|Null-hypothesis significance test|Slope|-0.00001|STANDARD_ERROR_OF_MEAN|0.0004||0.973|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(growth model) to superior temporal SUVR. Growth modeling was performed using SPSS curve estimation.||||.973
71055448|NCT04080544|141614947|OTHER|Null-hypothesis significance test|Slope|0.001|STANDARD_ERROR_OF_MEAN|0.001||0.2|TWO_SIDED|95.0|-0.001|0.003||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(linear) to entorhinal SUVR.||0.003|-0.001|.200
71055449|NCT04080544|141614947|OTHER|Null-hypothesis significance test|Slope|0.00005|STANDARD_ERROR_OF_MEAN|0.00005||0.346|TWO_SIDED|95.0|-0.00005|0.0001||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(quadratic) to entorhinal SUVR.||0.0001|-0.00005|.346
71055450|NCT04080544|141614947|OTHER|Null-hypothesis significance test|Slope|0.001|STANDARD_ERROR_OF_MEAN|0.001||0.283|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing relationship of age(growth model) to entorhinal SUVR. Growth modeling was performed using SPSS curve estimation.||||.283
71055451|NCT04080544|141614947|OTHER|Null-hypothesis significance test|Slope|0.002|STANDARD_ERROR_OF_MEAN|0.001||0.011|TWO_SIDED|95.0|0.0004|0.003||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(linear) to parahippocampal SUVR.||0.003|0.0004|.011
71055452|NCT04080544|141614947|OTHER|Null-hypothesis significance test|Slope|0.00002|STANDARD_ERROR_OF_MEAN|0.00003||0.536|TWO_SIDED|95.0|-0.00004|0.00009||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(quadratic) to parahippocampal SUVR.||0.00009|-0.00004|.536
71107121|NCT03950856|141720647|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.72|0.94|||||Lot 1 divided by Lot 2|Serotype 4: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|0.94|0.72|
70933374|NCT03861052|141367863|SUPERIORITY||Least Squares Mean Difference|-1.27|||<|0.001|TWO_SIDED|95.0|-1.45|-1.08|||Mixed Models Analysis|||||-1.08|-1.45|<0.001
70933375|NCT03861052|141367863|SUPERIORITY||Least Squares Mean Difference|-1.53|||<|0.001|TWO_SIDED|95.0|-1.71|-1.35|||Mixed Models Analysis|||||-1.35|-1.71|<0.001
71022199|NCT04133519|141552403|SUPERIORITY||Mean Difference (Final Values)|0.044||||0.7564|TWO_SIDED|95.0|-0.236|0.325|||ANOVA|||Average abdominal pain frequency at Week 13-16 will be statistically compared between GDH and comparator using an ANOVA model adjusted for gender and IBS subtype. The daily pain frequency measurement was derived from the daily pain intensity measurement. Days where severity was \>0 were considered a day with pain and were recorded as positive. Days with a score of 0 were days without pain. Mean represents the mean number of days in each time period with abdominal pain.||0.325|-0.236|0.7564
70933376|NCT03861052|141367864|SUPERIORITY||Odds Ratio (OR)|9.89|||<|0.001|TWO_SIDED|95.0|4.53|21.55|||Regression, Logistic|||||21.55|4.53|<0.001
70933377|NCT03861052|141367864|SUPERIORITY||Odds Ratio (OR)|20.57|||<|0.001|TWO_SIDED|95.0|7.73|54.71|||Regression, Logistic|||||54.71|7.73|<0.001
71022200|NCT04133519|141552404|SUPERIORITY||Odds Ratio (OR)|1.17||||0.4753|TWO_SIDED|95.0|0.76|1.81||P-value from Cochran-Mantel-Haenszel Test testing H0: OR=1; H1: OR\<\>1 adjusting for IBS subtype and gender|Cochran-Mantel-Haenszel||GDH:MR Relative Risk|A Stool Consistency Responder is defined as a \>=30% improvement in the proportion of Bristol Stool Form Scale (BSFS) scores that fall within Group 2 (normal stools)||1.81|0.76|0.4753
71022201|NCT04133519|141552405|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.6793|TWO_SIDED|95.0|-0.301|0.46|||Mixed Models Analysis|||"The analysis is based on the mixed model repeated measures (MMRM) analysis of variance model for IBS-C participants:~parameter = treatment + timepoint + treatment\*timepoint + gender + subject error + random Means are the mean daily number of bowel movements for a 24-hour period."||0.460|-0.301|0.6793
71022202|NCT04133519|141552405|SUPERIORITY||Mean Difference (Final Values)|0.173||||0.9468|TWO_SIDED|95.0|-4.904|5.249|||Mixed Models Analysis|||"The analysis is based on the mixed model repeated measures (MMRM) analysis of variance model for IBS-D participants:~parameter = treatment + timepoint + treatment\*timepoint + gender + subject error + random Means are the mean daily number of bowel movements for a 24-hour period."||5.249|-4.904|0.9468
71022203|NCT04133519|141552406|SUPERIORITY||Median Difference (Final Values)|-1.602||||0.5015|TWO_SIDED|95.0|-6.282|3.077|||Mixed Models Analysis|||"The analysis is based on the mixed model repeated measures (MMRM) analysis of variance model:~parameter = treatment + timepoint + treatment\*timepoint + gender + subject error + random The unstructured covariance matrix was used to model the within-participant correlation. The model-based least square (LS) means and LS mean differences (GDH minus comparator) and associated 95% CIs for each week and overall were estimated."||3.077|-6.282|0.5015
71022204|NCT04133519|141552407|SUPERIORITY||Mean Difference (Final Values)|4.586||||0.2117|TWO_SIDED|95.0|-2.619|11.79|||Mixed Models Analysis|||"Percent Overall Work Impairment Due to IBS defined as the percent time missed by not showing up for work, plus the percent time missed while working, and calculated as: Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\]."||11.790|-2.619|0.2117
71022205|NCT04133519|141552408|SUPERIORITY||Mean Difference (Net)|2.372||||0.3676|TWO_SIDED|95.0|-2.793|7.537|||Mixed Models Analysis|||The analysis is based on the mixed model repeated measures (MMRM) analysis of variance model: parameter = treatment + timepoint + treatment\*timepoint + gender + subject error + random||7.537|-2.793|0.3676
71022206|NCT00475852|141552409|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.7||||0.313|TWO_SIDED|95.0|-2.1|0.7|||Cochran-Mantel-Haenszel|Stratified by geographical region.||||0.7|-2.1|0.313
71022207|NCT00475852|141552410|SUPERIORITY_OR_OTHER|||||||0.03|||||||Van Elteren test|Controlled for region.||||||0.030
71022208|NCT00475852|141552411|SUPERIORITY_OR_OTHER|||||||0.007|||||||Van Elteren test|Controlled for region.||||||0.007
71022209|NCT00475852|141552412|SUPERIORITY_OR_OTHER|||||||0.318|||||||Van Elteren test|Controlled for region.||||||0.318
71022210|NCT00475852|141552413|SUPERIORITY_OR_OTHER|||||||0.018|||||||Van Elteren test|Controlled for region.||||||0.018
71022211|NCT00475852|141552414|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.5||||0.295|TWO_SIDED|95.0|-1.5|0.5|||Cochran-Mantel-Haenszel|Controlled for region.||||0.5|-1.5|0.295
71022212|NCT00475852|141552415|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.17||0.16|||||||ANOVA|Controlled for region.|This analysis excluded subjects who were lost to follow-up, or withdrawal of consent before Day 30, or whose Day 30 visit occurred prior to Day 30.|||||0.160
71022213|NCT00475852|141552416|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.9||||0.238|TWO_SIDED|95.0|-2.4|0.6|||Cochran-Mantel-Haenszel|Controlled for region.|For subjects with a Day 30 visit prior to Day 30, information from their Day 180 visit, if available, was used to impute the mortality and rehospitalization status at Day 30.|||0.6|-2.4|0.238
70933378|NCT03861052|141367864|SUPERIORITY||Odds Ratio (OR)|85.31|||<|0.001|TWO_SIDED|95.0|15.8|460.58|||Regression, Logistic|||||460.58|15.80|<0.001
71022214|NCT00475852|141552420|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.109|TWO_SIDED|95.0|0.98|1.21|||Cochran-Mantel-Haenszel|Controlled for region.||||1.21|0.98|0.109
71022215|NCT02273206|141552431|SUPERIORITY|||||||0.2562|||||||Chi-squared|p\<0.05||Colorectal Cancer Screening Intervention Arm Difference||||0.2562
71022216|NCT02273206|141552431|SUPERIORITY|||||||0.9795|||||||Chi-squared|p\<0.05||Breast Cancer Screening Intervention Arm Difference||||0.9795
71022217|NCT02273206|141552431|SUPERIORITY|||||||0.3917|||||||Chi-squared|p\<0.05||Cervical Cancer Screening Intervention Arm Difference||||0.3917
71022218|NCT02273206|141552432|SUPERIORITY|Test the coefficient for intervention|Odds Ratio (OR)|1.346||||0.0677|TWO_SIDED|95.0|0.979|1.851||Treatment Group (CCI vs PCM)|Regression, Logistic|p\<0.05|In the logistic regression model, adjustments were made for PHQ9 at baseline, improvement of depression by one level, baseline colorectal cancer up to date status, age, and income.|||1.851|0.979|0.0677
71107122|NCT03950856|141720647|OTHER||GMC Ratio|1.07|||||TWO_SIDED|95.0|0.94|1.23|||||Lot 1 divided by Lot 3|Serotype 4: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.23|0.94|
70933379|NCT03861052|141367865|SUPERIORITY||Least Squares Mean Difference|-25.9|||<|0.001|TWO_SIDED|95.0|-30.7|-21.1|||Mixed Models Analysis|||||-21.1|-30.7|<0.001
70933380|NCT03861052|141367865|SUPERIORITY||Least Squares Mean Difference|-32.7|||<|0.001|TWO_SIDED|95.0|-37.5|-27.8|||Mixed Models Analysis|||||-27.8|-37.5|<0.001
70933381|NCT03861052|141367865|SUPERIORITY||Least Squares Mean Difference|-35.7|||<|0.001|TWO_SIDED|95.0|-40.6|30.9|||Mixed Models Analysis|||||30.9|-40.6|<0.001
71055453|NCT04080544|141614947|OTHER|Null-hypothesis significance test|Slope|0.001|STANDARD_ERROR_OF_MEAN|0.001||0.013|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(growth model) to parahippocampal SUVR. Growth modeling was performed using SPSS curve estimation.||||.013
71055454|NCT04080544|141614947|OTHER|Null-hypothesis significance test|Slope|0.002|STANDARD_ERROR_OF_MEAN|0.0005|<|0.001|TWO_SIDED|95.0|0.001|0.003||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(linear) to fusiform SUVR.||0.003|0.001|<.001
71055455|NCT04080544|141614947|OTHER|Null-hypothesis significance test|Slope|0.00001|STANDARD_ERROR_OF_MEAN|0.00003||0.692|TWO_SIDED|95.0|-0.00004|0.00006||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(quadratic) to fusiform SUVR.||0.00006|-0.00004|.692
71055456|NCT04080544|141614947|OTHER|Null-hypothesis significance test|Slope|0.001|STANDARD_ERROR_OF_MEAN|0.0004|<|0.001|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(growth model) to fusiform SUVR. Growth modeling was performed using SPSS curve estimation.||||<.001
71055457|NCT04080544|141614948|OTHER|Null-hypothesis significance testing|Slope|0.18|STANDARD_ERROR_OF_MEAN|0.18||0.331|TWO_SIDED|95.0|-0.18|0.53||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to inferior temporal gyrus cortical thickness.||0.53|-0.18|.331
71055458|NCT04080544|141614948|OTHER|Null-hypothesis significance testing|Slope|0.07|STANDARD_ERROR_OF_MEAN|0.16||0.636|TWO_SIDED|95.0|-0.24|0.39||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education||Regression testing the relationship between temporal tau SUVR to middle temporal gyrus cortical thickness.||0.39|-0.24|.636
71055459|NCT04080544|141614948|OTHER|Null-hypothesis significance testing|Slope|0.38|STANDARD_ERROR_OF_MEAN|0.16||0.024|TWO_SIDED|95.0|0.05|0.7||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship between temporal tau SUVR to superior temporal gyrus cortical thickness.||0.70|0.05|.024
71055460|NCT04080544|141614948|OTHER|Null-hypothesis significance testing|Slope|-0.27|STANDARD_ERROR_OF_MEAN|0.23||0.235|TWO_SIDED|95.0|-0.73|0.18||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship between temporal tau SUVR to parahippocampal gyrus cortical thickness.||0.18|-0.73|.235
71055461|NCT04080544|141614948|OTHER|Null-hypothesis significance testing|Slope|0.19|STANDARD_ERROR_OF_MEAN|0.41||0.639|TWO_SIDED|95.0|-0.63|1.01||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship between temporal tau SUVR to entorhinal gyrus cortical thickness.||1.01|-0.63|.639
71055462|NCT04080544|141614948|OTHER|Null-hypothesis significance test|Slope|0.19|STANDARD_ERROR_OF_MEAN|0.16||0.252|TWO_SIDED|95.0|-0.13|0.5||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to fusiform gyrus cortical thickness.||0.50|-0.13|.252
71055463|NCT04080544|141614949|OTHER|Null-hypothesis significance test|Slope|-233.74|STANDARD_ERROR_OF_MEAN|469.31||0.619|TWO_SIDED|95.0|-1163.28|695.79||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to hippocampal volume.||695.79|-1163.28|.619
71055464|NCT04080544|141614950|OTHER|Null-hypothesis significance test|Slope|9260.01|STANDARD_ERROR_OF_MEAN|3836.92||0.017|TWO_SIDED|95.0|1660.52|16859.51||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to volume of white matter hypointensities.||16859.51|1660.52|.017
71055465|NCT04080544|141614951|OTHER|Null-hypothesis significance test|Slope|0.29|STANDARD_ERROR_OF_MEAN|0.35||0.411|TWO_SIDED|95.0|-0.41|0.99||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to activation of inferior frontal gyrus (beta) on the semantic judgment fMRI task.||0.99|-0.41|.411
71055466|NCT04080544|141614951|OTHER|Null-hypothesis significance test|Slope|0.24|STANDARD_ERROR_OF_MEAN|0.29||0.412|TWO_SIDED|95.0|-0.34|0.81||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to middle temporal gyrus activation (beta) on the semantic judgment fMRI task.||0.81|-0.34|.412
71055467|NCT04080544|141614951|OTHER|Null-hypothesis significance test|Slope|0.31|STANDARD_ERROR_OF_MEAN|0.4||0.438|TWO_SIDED|95.0|-0.48|1.09||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to precuneus gyrus activation (beta) on the semantic judgment fMRI task.||1.09|-0.48|.438
71055468|NCT04080544|141614952|OTHER|Null-hypothesis significance test|Slope|-1.13|STANDARD_ERROR_OF_MEAN|0.5||0.026|TWO_SIDED|95.0|-2.12|-0.14||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to resting-state system segregation.||-0.14|-2.12|.026
71055469|NCT00469911|141615006|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70933382|NCT03861052|141367866|SUPERIORITY||Least Squares Mean Difference|-17.3|||<|0.001|TWO_SIDED|95.0|-21.4|-13.2|||ANCOVA|||||-13.2|-21.4|<0.001
70851417|NCT03462511|141190707|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||We compared the difference in proportion of days covered by hydroxyurea at two timepoints: (1) from the year prior to study entry to 6 months (the end of the active intervention phase of the trial) and (2) from 6 months to 12 months (the sustainability phase of the trial).||||0.60
70933383|NCT03861052|141367866|SUPERIORITY||Least Squares Mean Difference|-22.0|||<|0.001|TWO_SIDED|95.0|-26.1|-17.9|||ANCOVA|||||-17.9|-26.1|<0.001
71022219|NCT02273206|141552433|SUPERIORITY|Test the coefficient for intervention|Odds Ratio (OR)|1.031||||0.8501|TWO_SIDED|95.0|0.753|1.41||Treatment Group (CCI vs PCM)|Regression, Logistic|p\<0.05|In the logistic regression model, adjustments were made for PHQ9 at baseline, improvement of depression by one level, baseline breast cancer up to date status, age, and income|||1.410|0.753|0.8501
71107123|NCT03950856|141720647|OTHER||GMC Ratio|1.31|||||TWO_SIDED|95.0|1.14|1.5||||P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 4: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.50|1.14|
71107124|NCT03950856|141720647|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.72|0.95|||||Lot 1 divided by Lot 2|Serotype 5: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|0.95|0.72|
70933384|NCT03861052|141367866|SUPERIORITY||Least Squares Mean Difference|-26.4|||<|0.001|TWO_SIDED|95.0|-30.5|-22.2|||ANCOVA|||||-22.2|-30.5|<0.001
71022220|NCT02273206|141552434|SUPERIORITY|Test the coefficient for intervention|Odds Ratio (OR)|0.876||||0.4432|TWO_SIDED|95.0|0.625|1.228||Treatment Group(CCI vs PCM)|Regression, Logistic|p\<0.05|In the logistic regression model, adjustments were made for PHQ9 at baseline, improvement of depression by one level, baseline cervical cancer up to date status, age, and income.|||1.228|0.625|0.4432
71022221|NCT02273206|141552435|SUPERIORITY|||||||0.39|||||||Two-sample t-test|p\<0.05||PHQ9 Intervention Arm Difference between baseline and 12-month follow up||||0.39
71022222|NCT02273206|141552436|SUPERIORITY|||||||0.6|||||||Chi-squared|||The Hopkins Symptom Checklist (SCL-20) at baseline.||||0.60
71022223|NCT02273206|141552436|SUPERIORITY|||||||0.86|||||||Chi-squared|||The Hopkins Symptom Checklist (SCL-20) at 6 Months||||0.86
71022224|NCT02273206|141552437|SUPERIORITY|||||||0.6|||||||Chi-squared|||The Hopkins Symptom Checklist (SCL-20) at Baseline.||||0.60
71022225|NCT02273206|141552437|SUPERIORITY|||||||0.23|||||||Chi-squared|||The Hopkins Symptom Checklist (SCL-20) at 12 months.||||0.23
71022226|NCT02273206|141552438|SUPERIORITY|||||||0.4483|||||||Chi-squared|p\<0.05||Colorectal Cancer Screening Intervention Arm Difference at 12 Months||||0.4483
70933385|NCT03861052|141367867|SUPERIORITY||Least Squares Mean Difference|-5.2|||<|0.001|TWO_SIDED|95.0|-6.4|-4.1|||Mixed Models Analysis|||||-4.1|-6.4|<0.001
71022227|NCT02273206|141552438|SUPERIORITY|||||||0.1706|||||||Chi-squared|p\<0.05||Cervical Cancer Screening Intervention Arm Difference at 12 Months||||0.1706
71022228|NCT02273206|141552438|SUPERIORITY|||||||0.3568|||||||Chi-squared|p\<0.05||Breast Cancer Screening Intervention Arm Difference at 12 Months||||0.3568
71022229|NCT02273206|141552439|SUPERIORITY|||||||0.85|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Visits at baseline.||||0.85
70933386|NCT03861052|141367867|SUPERIORITY||Least Squares Mean Difference|-7.9|||<|0.001|TWO_SIDED|95.0|-9.1|-6.8|||Mixed Models Analysis|||||-6.8|-9.1|<0.001
71022230|NCT02273206|141552439|SUPERIORITY|||||||0.23|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Visits at 6 months.||||0.23
71022231|NCT02273206|141552439|SUPERIORITY|||||||0.98|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Visits at 12 months.||||0.98
71022232|NCT02273206|141552439|SUPERIORITY|||||||0.57|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Prescriptions at baseline.||||0.57
71022233|NCT02273206|141552439|SUPERIORITY|||||||0.92|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Prescriptions at 6 months.||||0.92
71022234|NCT02273206|141552439|SUPERIORITY|||||||0.99|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Prescriptions at 12 months.||||0.99
71022235|NCT02273206|141552440|SUPERIORITY|||||||0.2|||||||Chi-squared|||Satisfaction with decision to participate in colorectal cancer screening at baseline.||||0.20
71107125|NCT03950856|141720647|OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.84|1.11|||||Lot 1 divided by Lot 3|Serotype 5: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.11|0.84|
71107126|NCT03950856|141720647|OTHER||GMC Ratio|1.17|||||TWO_SIDED|95.0|1.02|1.35|||||Lot 2 divided by Lot 3|Serotype 5: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.35|1.02|
71107127|NCT03950856|141720647|OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.78|1.07|||||Lot 1 divided by Lot 2|Serotype 6A: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.07|0.78|
71107128|NCT03950856|141720647|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.85|1.16|||||Lot 1 divided by Lot 3|Serotype 6A: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.16|0.85|
71107129|NCT03950856|141720647|OTHER||GMC Ratio|1.08|||||TWO_SIDED|95.0|0.93|1.27|||||Lot 2 divided by Lot 3|Serotype 6A: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.27|0.93|
71022236|NCT02273206|141552440|SUPERIORITY|||||||0.17|||||||Chi-squared|||Satisfaction with decision to participate in colorectal cancer screening at 6 months.||||0.17
71107130|NCT03950856|141720647|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.82|1.11|||||Lot 1 divided by Lot 2|Serotype 6B: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.11|0.82|
71107131|NCT03950856|141720647|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.9|1.22|||||Lot 1 divided by Lot 3|Serotype 6B: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.22|0.90|
71107132|NCT03950856|141720647|OTHER||GMC Ratio|1.1|||||TWO_SIDED|95.0|0.94|1.28|||||Lot 2 divided by Lot 3|Serotype 6B: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.28|0.94|
71107133|NCT03950856|141720647|OTHER||GMC Ratio|0.8|||||TWO_SIDED|95.0|0.7|0.92|||||Lot 1 divided by Lot 2|Serotype 7F: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|0.92|0.70|
71107134|NCT03950856|141720647|OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.84|1.1|||||Lot 1 divided by Lot 3|Serotype 7F: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.10|0.84|
71107135|NCT03950856|141720647|OTHER||GMC Ratio|1.2|||||TWO_SIDED|95.0|1.04|1.37|||||Lot 2 divided by Lot 3|Serotype 7F: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.37|1.04|
71107136|NCT03950856|141720647|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.83|1.08|||l||Lot 1 divided by Lot 2|Serotype 9V: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.08|0.83|
71107137|NCT03950856|141720647|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.87|1.13|||||Lot 1 divided by Lot 3|Serotype 9V: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.13|0.87|
71107138|NCT03950856|141720647|OTHER||GMC Ratio|1.04|||||TWO_SIDED|95.0|0.91|1.19|||||Lot 2 divided by Lot 3|Serotype 9V: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.19|0.91|
71022237|NCT02273206|141552440|SUPERIORITY|||||||0.69|||||||Chi-squared|||Satisfaction with decision to participate in colorectal cancer screening at 12 months.||||0.69
71107139|NCT03950856|141720647|OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.75|1.0|||||Lot 1 divided by Lot 2|Serotype 14: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.00|0.75|
71022238|NCT02273206|141552440|SUPERIORITY|||||||0.72|||||||Chi-squared|||Satisfaction with decision to participate in breast cancer screening at baseline.||||0.72
71022239|NCT02273206|141552440|SUPERIORITY|||||||0.72|||||||Chi-squared|||Satisfaction with decision to participate in breast cancer screening at 6 months.||||0.72
71022240|NCT02273206|141552440|SUPERIORITY|||||||0.87|||||||Chi-squared|||Satisfaction with decision to participate in breast cancer screening at 12 months.||||0.87
71022241|NCT02273206|141552440|SUPERIORITY|||||||0.65|||||||Chi-squared|||Satisfaction with decision to participate in cervical cancer screening at baseline.||||0.65
71022242|NCT02273206|141552440|SUPERIORITY|||||||0.82|||||||Chi-squared|||Satisfaction with decision to participate in cervical cancer screening at 6 months.||||0.82
71107140|NCT03950856|141720647|OTHER||GMC Ratio|1.13|||||TWO_SIDED|95.0|0.98|1.31|||||Lot 1 divided by Lot 3|Serotype 14: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.31|0.98|
71107141|NCT03950856|141720647|OTHER||GMC Ratio|1.31|||||TWO_SIDED|95.0|1.14|1.52|||||Lot 2 divided by Lot 3|Serotype 14: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.52|1.14|
71107142|NCT03950856|141720647|OTHER||GMC Ratio|1.19|||||TWO_SIDED|95.0|1.04|1.36|||||Lot 1 divided by Lot 2|Serotype 18C: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.36|1.04|
71107143|NCT03950856|141720647|OTHER||GMC Ratio|1.32|||||TWO_SIDED|95.0|1.15|1.51|||||Lot 1 divided by Lot 3|Serotype 18C: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.51|1.15|
71107144|NCT03950856|141720647|OTHER||GMC Ratio|1.11|||||TWO_SIDED|95.0|0.97|1.27|||||Lot 2 divided by Lot 3|Serotype 18C: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.27|0.97|
71107145|NCT03950856|141720647|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.78|1.02|||||Lot 1 divided by Lot 2|Serotype 19A: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.02|0.78|
71107146|NCT03950856|141720647|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.86|1.11|||||Lot 1 divided by Lot 3|Serotype 19A: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.11|0.86|
71107147|NCT03950856|141720647|OTHER||GMC Ratio|1.1|||||TWO_SIDED|95.0|0.96|1.25|||||Lot 2 divided by Lot 3|Serotype 19A: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.25|0.96|
71107148|NCT03950856|141720647|OTHER||GMC Ratio|0.87|||||TWO_SIDED|95.0|0.76|1.0|||||Lot 1 divided by Lot 2|Serotype 19F: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.00|0.76|
71107149|NCT03950856|141720647|OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.8|1.05|||||Lot 1 divided by Lot 3|Serotype 19F: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.05|0.80|
71107150|NCT03950856|141720647|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.92|1.21|||||Lot 2 divided by Lot 3|Serotype 19F: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.21|0.92|
71107151|NCT03950856|141720647|OTHER||GMC Ratio|0.93|||||TWO_SIDED|95.0|0.8|1.07|||||Lot 1 divided by Lot 2|Serotype 23F: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.07|0.80|
71107152|NCT03950856|141720647|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.86|1.15|||||Lot 1 divided by Lot 3|Serotype 23F: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.15|0.86|
71107153|NCT03950856|141720647|OTHER||GMC Ratio|1.07|||||TWO_SIDED|95.0|0.93|1.24|||||Lot 2 divided by Lot 3|Serotype 23F: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.24|0.93|
71107154|NCT03950856|141720647|OTHER||GMC Ratio|0.93|||||TWO_SIDED|95.0|0.81|1.08|||||Lot 1 divided by Lot 2|Serotype 22F: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.08|0.81|
71107155|NCT03950856|141720647|OTHER||GMC Ratio|1.08|||||TWO_SIDED|95.0|0.93|1.26|||||Lot 1 divided by Lot 3|Serotype 22F: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.26|0.93|
71107156|NCT03950856|141720647|OTHER||GMC Ratio|1.16|||||TWO_SIDED|95.0|1.0|1.35|||||Lot 2 divided by Lot 3|Serotype 22F: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.35|1.00|
71022243|NCT02273206|141552440|SUPERIORITY|||||||0.92|||||||Chi-squared|||Satisfaction with decision to participate in cervical cancer screening at 12 months.||||0.92
71022244|NCT02273206|141552440|SUPERIORITY|||||||0.56|||||||Chi-squared|||Satisfaction with decision to participate in Mental Health Care at 12 months.||||0.56
71022245|NCT02273206|141552441|SUPERIORITY|||||||0.17|||||||Chi-squared|||Physician Recommendation of Colorectal Cancer Screening at baseline.||||0.17
70851418|NCT03462511|141190708|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||We hypothesized that, compared to the control group, generic quality of life (QOL) for youth in the intervention group would improve from baseline to 9 months.||||<0.001
71022246|NCT02273206|141552441|SUPERIORITY|||||||0.38|||||||Chi-squared|||Physician Recommendation of Colorectal Cancer Screening at 6 months.||||0.38
71022247|NCT02273206|141552441|SUPERIORITY|||||||0.07|||||||Chi-squared|||Physician Recommendation of Colorectal Cancer Screening at 12 months.||||0.07
71022248|NCT02273206|141552441|SUPERIORITY|||||||0.99|||||||Chi-squared|||Physician Recommendation of Breast Cancer Screening at baseline.||||0.99
71022249|NCT02273206|141552441|SUPERIORITY|||||||0.15|||||||Chi-squared|||Physician Recommendation of Breast Cancer Screening at 6 months.||||0.15
71022250|NCT02273206|141552441|SUPERIORITY|||||||0.55|||||||Chi-squared|||Physician Recommendation of Breast Cancer Screening at 12 months.||||0.55
71022251|NCT02273206|141552441|SUPERIORITY|||||||0.34|||||||Chi-squared|||Physician Recommendation of Cervical Cancer Screening at baseline.||||0.34
71022252|NCT02273206|141552441|SUPERIORITY|||||||0.31|||||||Chi-squared|||Physician Recommendation of Cervical Cancer Screening at 6 months. .||||0.31
71022253|NCT02273206|141552441|SUPERIORITY|||||||0.39|||||||Chi-squared|||Physician Recommendation of Cervical Cancer Screening at 12 months.||||0.39
71022254|NCT02273206|141552441|SUPERIORITY|||||||0.87|||||||Chi-squared|||Physician Recommendation of Mental Health Care at baseline.||||0.87
71022255|NCT02273206|141552441|SUPERIORITY|||||||0.83|||||||Chi-squared|||Physician Recommendation of Mental Health Care at 6 months.||||0.83
71107157|NCT03950856|141720647|OTHER||GMC Ratio|0.91|||||TWO_SIDED|95.0|0.79|1.06|||||Lot 1 divided by Lot 2|Serotype 33F: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.06|0.79|
70851419|NCT03462511|141190708|NON_INFERIORITY|30% of the standard deviation was used as the non-inferiority margin. For this test generic quality of life (QOL) scores for months 4-9 (efficacy period) were compared to months \>9 (sustainability period).||||||0.04|||||||Regression, Linear|||We hypothesized that the improvement in quality of life experienced by the intervention group would be sustained from month 9 to month 12.||||0.04
70851420|NCT03462511|141190709|SUPERIORITY|||||||0.47|||||||Regression, Linear|||We hypothesized that, compared to the control group, sickle cell disease specific quality of life (SC-QOL) for youth in the intervention group would improve from baseline to 9 months.||||0.47
70851421|NCT03462511|141190709|NON_INFERIORITY|30% of the standard deviation was used as the non-inferiority margin. For this test sickle cell disease specific quality of life (SC-QOL) scores for months 4-9 (efficacy period) were compared to months \>9 (sustainability period).||||||0.045|||||||Regression, Linear|||We hypothesized that the improvement in sickle cell disease specific quality of life (SC-QOL) experienced by the intervention group would be sustained from month 9 to month 12.||||0.045
70851422|NCT03462511|141190710|SUPERIORITY|||||||0.002|||||||Regression, Linear|||We hypothesized that, compared to the control group, responsibility for self-management concordance for youth-caregiver dyads in the intervention group would improve from baseline to 6 months.||||0.002
70933387|NCT03861052|141367867|SUPERIORITY||Least Squares Mean Difference|-10.1|||<|0.001|TWO_SIDED|95.0|-11.3|-9.0|||Mixed Models Analysis|||||-9.0|-11.3|<0.001
70933388|NCT03861052|141367868|SUPERIORITY||Odds Ratio (OR)|14.44|||<|0.001|TWO_SIDED|95.0|7.88|26.46|||Regression, Logistic|||||26.46|7.88|<0.001
71022256|NCT02273206|141552441|SUPERIORITY|||||||0.36|||||||Chi-squared|||Physician Recommendation of Mental Health Care at 12 months.||||0.36
71022257|NCT02273206|141552442|SUPERIORITY|||||||0.95|||||||Chi-squared|||Generalized Anxiety Disorder scale at baseline. Coding of the measure was based on Spitzer, R.L., Kroenke, K., Williams, J.B., \& Lowe, B. (2006).||||0.95
71022258|NCT02273206|141552442|SUPERIORITY|||||||0.08|||||||Chi-squared|||Generalized Anxiety Disorder scale score at 6 months. Coding of the measure was based on Spitzer, R.L., Kroenke, K., Williams, J.B., \& Lowe, B. (2006).||||0.08
71022259|NCT02273206|141552442|SUPERIORITY|||||||0.27|||||||Chi-squared|||Generalized Anxiety Disorder scale score at 12 months. Coding of the measure was based on Spitzer, R.L., Kroenke, K., Williams, J.B., \& Lowe, B. (2006).||||0.27
71022260|NCT02273206|141552443|SUPERIORITY|||||||0.54|||||||Chi-squared|||Medical Outcomes Study Health Survey at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.54
71022261|NCT02273206|141552443|SUPERIORITY|||||||0.68|||||||Chi-squared|||Medical Outcomes Study Health Survey at 6 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.68
71022262|NCT02273206|141552443|SUPERIORITY|||||||0.68|||||||Chi-squared|||Medical Outcomes Study Health Survey at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.68
71022263|NCT02273206|141552444|SUPERIORITY|||||||0.74|||||||Chi-squared|||Colorectal Cancer Screening attitudes at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.74
70851423|NCT03462511|141190710|NON_INFERIORITY|50% of the standard deviation was used as the non-inferiority margin. For this test youth caregiver concordance for self-management responsibility scores for months 0-6 (efficacy period) were compared to months 6-12 (sustainability period).||||||0.23|||||||Regression, Linear|||We hypothesized that the improvement in concordance between youth and caregivers for self-management responsibility experienced by the intervention group would be sustained from month 6 to month 12.||||0.23
71022264|NCT02273206|141552444|SUPERIORITY|||||||0.86|||||||Chi-squared|||Colorectal Cancer Screening attitudes at 6 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.86
71022265|NCT02273206|141552444|SUPERIORITY|||||||0.79|||||||Chi-squared|||Colorectal Cancer Screening attitudes at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.79
71022266|NCT02273206|141552444|SUPERIORITY|||||||0.91|||||||Chi-squared|||Breast Cancer Screening attitudes at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.91
71055470|NCT01908907|141615010|SUPERIORITY_OR_OTHER||Median Difference (Net)|13.5|STANDARD_ERROR_OF_MEAN|6.5||0.07|TWO_SIDED|95.0|0.2|28.7|||Regression, Linear|Outcome was transformed using a natural logarithm transformation. Models included gestational age group since the randomization was blocked.|Since analyzed on the log scale, estimates provide are % change rather than absolute change between group.|All analyses used the intent-to-treat study population. A linear mixed model was used to assess differences in time to full feeds, days on study drug, and gestational age at discharge. These models included a random effect for multiples, which was maintained in the model after testing. Fixed effects included treatment and GA group for time to full feeds and days on study drug and treatment effect for gestational age at discharge.||28.7|0.2|0.07
71055471|NCT01908907|141615011|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.016|STANDARD_ERROR_OF_MEAN|0.008||0.048|TWO_SIDED||||||Regression, Linear|This is a complex regression model including linear and quadratic growth and interactions as specified above.||Linear mixed models were used to explore growth over time (weight, length and head circumference). These models included a random effect for intercepts and slopes to account for subject specific growth over time as well as a random effect for possible correlation between twins and triplets present in the data set. Fixed effects included both a linear and quadratic time effect, GA at birth, treatment group, full feeds (yes/no), and interactions. Non-significant interactions were eliminated.||||0.048
71055472|NCT00761657|141615019|OTHER|||||||0.2073||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.2073
71055473|NCT00761657|141615019|OTHER|||||||0.0046||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.0046
71055474|NCT00761657|141615019|OTHER|||||||0.086||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.0860
71055475|NCT00761657|141615019|OTHER|||||||0.4005||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.4005
71055476|NCT00761657|141615019|OTHER||||||<|0.0001||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is presented for Day 26-29 timepoint. P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||<0.0001
71055477|NCT00761657|141615019|OTHER||||||<|0.0001||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||<0.0001
71055478|NCT00761657|141615019|OTHER||||||<|0.0001||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||<0.0001
71107158|NCT03950856|141720647|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.9|1.22|||||Lot 1 divided by Lot 3|Serotype 33F: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.22|0.90|
70933389|NCT03861052|141367868|SUPERIORITY||Odds Ratio (OR)|44.96|||<|0.001|TWO_SIDED|95.0|23.12|87.45|||Regression, Logistic|||||87.45|23.12|<0.001
71055479|NCT00761657|141615019|OTHER||||||<|0.0001|||||||t-test, 2 sided|Threshold for significance at 0.05 level.||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||<0.0001
71055480|NCT00761657|141615020|OTHER|||||||0.0507||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.0507
71055481|NCT00761657|141615020|OTHER|||||||0.4502||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.4502
71055482|NCT00761657|141615020|OTHER|Threshold for significance at 0.05 level.||||||0.1603|||||||t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.1603
71055483|NCT00761657|141615020|OTHER|||||||0.9816||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.9816
71055484|NCT00761657|141615020|OTHER|||||||0.0139||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.0139
71055485|NCT00761657|141615020|OTHER||||||<|0.0001||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||<0.0001
71107159|NCT03950856|141720647|OTHER||GMC Ratio|1.15|||||TWO_SIDED|95.0|0.99|1.34|||||Lot 2 divided by Lot 3|Serotype 33F: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.34|0.99|
70933390|NCT03861052|141367868|SUPERIORITY||Odds Ratio (OR)|82.67|||<|0.001|TWO_SIDED|95.0|39.84|171.52|||Regression, Logistic|||||171.52|39.84|<0.001
70933391|NCT03861052|141367869|SUPERIORITY||Least Squares Mean Difference|-2.47|STANDARD_ERROR_OF_MEAN|0.61|<|0.001|TWO_SIDED|95.0|-3.67|-1.28|||Mixed Models Analysis|||||-1.28|-3.67|<0.001
71055486|NCT00761657|141615020|OTHER|||||||0.0001||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.0001
71107160|NCT03950856|141720648|OTHER||GMC Ratio|0.75|||||TWO_SIDED|95.0|0.62|0.91|||||V114 Combined Lots divided by Prevnar 13™|Serotype 1: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|0.91|0.62|
71107161|NCT03950856|141720648|OTHER||GMC Ratio|1.39|||||TWO_SIDED|95.0|1.2|1.61|||||V114 Combined Lots divided by Prevnar 13™|Serotype 3: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.61|1.20|
70933392|NCT03861052|141367869|SUPERIORITY||Least Squares Mean Difference|-3.27|STANDARD_ERROR_OF_MEAN|0.592|<|0.001|TWO_SIDED|95.0|-4.43|-2.11|||Mixed Models Analysis|||||-2.11|-4.43|<0.001
70933393|NCT03861052|141367869|SUPERIORITY||Least Squares Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.587|<|0.001|TWO_SIDED|95.0|-4.55|-2.25|||Mixed Models Analysis|||||-2.25|-4.55|<0.001
70933394|NCT03861052|141367870|SUPERIORITY||Least Squares Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.069|<|0.001|TWO_SIDED|95.0|-0.4|-0.13|||Mixed Models Analysis|||||-0.13|-0.40|<0.001
70933395|NCT03861052|141367870|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.067|<|0.001|TWO_SIDED|95.0|-0.53|-0.27|||Mixed Models Analysis|||||-0.27|-0.53|<0.001
70933396|NCT03861052|141367870|SUPERIORITY||Least Squares Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.067|<|0.001|TWO_SIDED|95.0|-0.51|-0.25|||Mixed Models Analysis|||||-0.25|-0.51|<0.001
70933397|NCT03861052|141367871|SUPERIORITY||Least Squares Mean Difference|16.1|STANDARD_ERROR_OF_MEAN|2.72|<|0.001|TWO_SIDED|95.0|10.7|21.4|||Mixed Models Analysis|||||21.4|10.7|<0.001
70933398|NCT03861052|141367871|SUPERIORITY||Least Squares Mean Difference|20.6|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|14.9|26.3|||Mixed Models Analysis|||||26.3|14.9|<0.001
70933399|NCT03861052|141367871|SUPERIORITY||Least Squares Mean Difference|23.9|STANDARD_ERROR_OF_MEAN|2.95|<|0.001|TWO_SIDED|95.0|18.1|29.7|||Mixed Models Analysis|||||29.7|18.1|<0.001
71022267|NCT02273206|141552444|SUPERIORITY|||||||0.71|||||||Chi-squared|||Breast Cancer Screening attitudes at 6 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.71
70933400|NCT03861052|141367872|SUPERIORITY||Least Squares Mean Difference|19.9|STANDARD_ERROR_OF_MEAN|4.22|<|0.001|TWO_SIDED|95.0|11.7|28.2|||Mixed Models Analysis|||||28.2|11.7|<0.001
71022268|NCT02273206|141552444|SUPERIORITY|||||||0.77|||||||Chi-squared|||Breast Cancer Screening attitudes at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.77
71022269|NCT02273206|141552444|SUPERIORITY|||||||0.64|||||||Chi-squared|||Cervical Cancer Screening attitudes at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.64
70933401|NCT03861052|141367872|SUPERIORITY||Least Squares Mean Difference|27.0|STANDARD_ERROR_OF_MEAN|4.59|<|0.001|TWO_SIDED|95.0|18.0|36.0|||Mixed Models Analysis|||||36.0|18.0|<0.001
70933402|NCT03861052|141367872|SUPERIORITY||Least Squares Mean Difference|31.2|STANDARD_ERROR_OF_MEAN|4.68|<|0.001|TWO_SIDED|95.0|22.0|40.4|||Mixed Models Analysis|||||40.4|22.0|<0.001
70933403|NCT03137459|141367884|SUPERIORITY||Risk Difference (RD)|0.059|||||TWO_SIDED|95.0|0.014|0.105|||||Analysis performed using GEE to account for clustering of participants within practices.|||.105|.014|
70933404|NCT03137459|141367884|SUPERIORITY||Odds Ratio (OR)|1.83|||||TWO_SIDED|95.0|1.14|2.93|||||Determined using mixed effects models, accounting for clustering of participants in practices and adjusting for unbalanced covariates: education, employment, stage of change for each ACP behavior|||2.93|1.14|
70933405|NCT03137459|141367885|SUPERIORITY||Risk Difference (RD)|0.082|||||TWO_SIDED|95.0|0.014|0.15|||||Adjusted for clustering|||.150|.014|
70933406|NCT03137459|141367885|SUPERIORITY||Odds Ratio (OR)|1.39|||||TWO_SIDED|95.0|0.96|2.0|||||Accounting for clustering and adjusted for covariates as described in primary outcome|||2.0|.96|
70933407|NCT03137459|141367886|SUPERIORITY||Risk Difference (RD)|0.133|||||TWO_SIDED|95.0|0.066|0.201|||||Accounting for clustering|||.201|.066|
70933408|NCT03137459|141367886|SUPERIORITY||Odds Ratio (OR)|1.73|||||TWO_SIDED|95.0|1.22|2.47|||||Accounting for clustering and adjusted for covariates as presenting for primary outcome|||2.47|1.22|
70933409|NCT03137459|141367887|SUPERIORITY||Risk Difference (RD)|0.07|||||TWO_SIDED|95.0|-0.05|0.188||||||||.188|-.05|
70933410|NCT03137459|141367887|SUPERIORITY||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.72|1.85|||||Accounting for clustering and adjusting for covariates as described for primary outcome|||1.85|.72|
70933411|NCT04921358|141367909|OTHER||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.75|1.39|||||Hazard ratio and 95% confidence intervals (CIs) were estimated using a Cox regression model stratified by histological subtype (nonsquamous vs squamous), race (Asian vs Non-Asian) and PD-L1 expression (\<1% Tumor Cells (TC) vs \>=1% TC).|||1.39|0.75|
70933412|NCT04921358|141367910|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.62|1.07|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by histological subtype (nonsquamous vs squamous), race (Asian vs Non-Asian) and PD-L1 expression (\<1% TC vs \>=1% TC).|||1.07|0.62|
70933413|NCT04921358|141367911|OTHER||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.5|0.83|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by histological subtype (nonsquamous vs squamous), race (Asian vs Non-Asian) and PD-L1 expression (\<1% TC vs \>=1% TC).|||0.83|0.50|
70933414|NCT05646719|141367926|SUPERIORITY||Odds Ratio (OR)|2.27|||<|0.01|TWO_SIDED|95.0|1.23|4.2|||t-test, 2 sided|||||4.20|1.23|<0.01
70933415|NCT05646719|141367926|SUPERIORITY||Odds Ratio (OR)|1.44|||||TWO_SIDED|95.0||||||||||||
70933416|NCT02372799|141367927|SUPERIORITY||LSMD|-0.4||||0.7662|TWO_SIDED|95.0|-3.08|2.27|||MMRM|||||2.27|-3.08|0.7662
71022270|NCT02273206|141552444|SUPERIORITY|||||||0.11|||||||Chi-squared|||Cervical Cancer Screening attitudes at 6 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.11
71022271|NCT02273206|141552444|SUPERIORITY|||||||1|||||||Chi-squared|||Cervical Cancer Screening attitudes at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||1.00
71022272|NCT02273206|141552446|SUPERIORITY|||||||0.56|||||||Chi-squared|||Satisfaction with decision to participate in Mental Health Care at 12 months. Recoding of the continuous measure was based on quartiles.||||0.56
71022273|NCT02273206|141552447|SUPERIORITY|||||||0.18|||||||Chi-squared|||Devaluation-Discrimination Scale Score at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.18
71022274|NCT02273206|141552447|SUPERIORITY|||||||0.32|||||||Chi-squared|||Devaluation-Discrimination Scale score at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.32
71107162|NCT03950856|141720648|OTHER||GMC Ratio|0.79|||||TWO_SIDED|95.0|0.66|0.94|||||V114 Combined Lots divided by Prevnar 13™|Serotype 4: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|0.94|0.66|
71107163|NCT03950856|141720648|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.74|1.07|||||V114 Combined Lots divided by Prevnar 13™|Serotype 5: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.07|0.74|
71107164|NCT03950856|141720648|OTHER||GMC Ratio|1.16|||||TWO_SIDED|95.0|0.95|1.43|||||V114 Combined Lots divided by Prevnar 13™|Serotype 6A: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.43|0.95|
71107165|NCT03950856|141720648|OTHER||GMC Ratio|1.5|||||TWO_SIDED|95.0|1.21|1.86|||||V114 Combined Lots divided by Prevnar 13™|Serotype 6B: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.86|1.21|
71107166|NCT03950856|141720648|OTHER||GMC Ratio|0.87|||||TWO_SIDED|95.0|0.73|1.04|||||V114 Combined Lots divided by Prevnar 13™|Serotype 7F: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.04|0.73|
71107167|NCT03950856|141720648|OTHER||GMC Ratio|0.87|||||TWO_SIDED|95.0|0.72|1.04|||||V114 Combined Lots divided by Prevnar 13™|Serotype 9V: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.04|0.72|
71107168|NCT03950856|141720648|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.82|1.2|||||V114 Combined Lots divided by Prevnar 13™|Serotype 14: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.20|0.82|
71107169|NCT03950856|141720648|OTHER||GMC Ratio|1.26|||||TWO_SIDED|95.0|1.05|1.51|||||V114 Combined Lots divided by Prevnar 13™|Serotype 18C: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.51|1.05|
71107170|NCT03950856|141720648|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.82|1.15|||||V114 Combined Lots divided by Prevnar 13™|Serotype 19A: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.15|0.82|
71022275|NCT02273206|141552448|SUPERIORITY|||||||0.5|||||||Chi-squared|||Ambulatory Care Experiences - Shared Decision Making at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.50
71107171|NCT03950856|141720648|OTHER||GMC Ratio|1.03|||||TWO_SIDED|95.0|0.86|1.23|||||V114 Combined Lots divided by Prevnar 13™|Serotype 19F: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.23|0.86|
71107172|NCT03950856|141720648|OTHER||GMC Ratio|1.26|||||TWO_SIDED|95.0|1.03|1.54|||||V114 Combined Lots divided by Prevnar 13™|Serotype 23F: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.54|1.03|
71107173|NCT03950856|141720648|OTHER||GMC Ratio|12.21|||||TWO_SIDED|95.0|10.11|14.74|||||V114 Combined Lots divided by Prevnar 13™|Serotype 22F: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|14.74|10.11|
71107174|NCT03950856|141720648|OTHER||GMC Ratio|9.42|||||TWO_SIDED|95.0|7.96|11.13|||||V114 Combined Lots divided by Prevnar 13™|Serotype 33F: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|11.13|7.96|
71022276|NCT02273206|141552448|SUPERIORITY|||||||0.51|||||||Chi-squared|||Ambulatory Care Experiences - Shared Decision Making at six months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.51
71107175|NCT03802396|141720719|OTHER|||||||0.025|||||||Wilcoxon (Mann-Whitney)|||||||0.025
71107176|NCT03802396|141720720|OTHER|||||||0.116|||||||Wilcoxon (Mann-Whitney)|||Baseline to 24 hours||||0.116
71107177|NCT03802396|141720720|OTHER|||||||0.388|||||||Wilcoxon (Mann-Whitney)|||Baseline to 6 weeks||||0.388
71107178|NCT03802396|141720721|OTHER|||||||0.569|||||||Wilcoxon (Mann-Whitney)|||Baseline to 24 hours||||0.569
71107179|NCT03802396|141720721|OTHER|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||Baseline to 6 weeks||||0.047
71107180|NCT03802396|141720722|OTHER|||||||0.498|||||||Wilcoxon (Mann-Whitney)|||Baseline to 24 hours||||0.498
71107181|NCT03802396|141720722|OTHER|||||||0.745|||||||Wilcoxon (Mann-Whitney)|||Baseline to 6 weeks||||0.745
70933417|NCT02372799|141367927|SUPERIORITY||LSMD|-2.39||||0.1433|TWO_SIDED|95.0|-5.6|0.81|||MMRM|||||0.81|-5.60|0.1433
71022277|NCT02273206|141552448|SUPERIORITY|||||||0.02|||||||Chi-squared|||Ambulatory Care Experiences - Shared Decision Making at twelve months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.02
71107182|NCT03802396|141720723|OTHER|||||||0.177|||||||Wilcoxon (Mann-Whitney)|||Baseline to 24 hours||||0.177
70933418|NCT02372799|141367928|SUPERIORITY||LSMD|-0.04||||0.7387|TWO_SIDED|95.0|-0.31|0.22|||MMRM|||||0.22|-0.31|0.7387
70933419|NCT02372799|141367928|SUPERIORITY||LSMD|-0.2||||0.2158|TWO_SIDED|95.0|-0.52|0.12|||MMRM|||||0.12|-0.52|0.2158
71107183|NCT03802396|141720723|OTHER|||||||0.478|||||||Wilcoxon (Mann-Whitney)|||Baseline to 6 weeks||||0.478
71107184|NCT03802396|141720724|OTHER|||||||0.803|||||||t-test, 2 sided|||||||0.803
71107185|NCT03802396|141720726|OTHER||Risk Ratio (RR)|0.73||||0.286|TWO_SIDED|95.0|0.41|1.3|||Chi-squared|||||1.30|0.41|0.286
71107186|NCT03802396|141720727|OTHER|||||||0.189|||||||Wilcoxon (Mann-Whitney)|||||||0.189
71107187|NCT00163293|141720728|SUPERIORITY_OR_OTHER|||||||0.6625||95.0|||||Log Rank|||||||0.6625
71107188|NCT00163293|141720728|SUPERIORITY_OR_OTHER|||||||0.7303||95.0|||||Log Rank|||||||0.7303
71107189|NCT00163293|141720729|SUPERIORITY_OR_OTHER|||||||0.1291||95.0|||||Wald Chi-square|zero inflated Poisson model: adjustment for centre and age \[yrs\] (zero model), treatment and race (Poisson model)||||||0.1291
71107190|NCT00163293|141720729|SUPERIORITY_OR_OTHER|||||||0.0145||95.0|||||Wald Chi-square|zero inflated Poisson model: adjustment for centre and age \[yrs\] (zero model), treatment and race (Poisson model)||||||0.0145
71107191|NCT00163293|141720731|SUPERIORITY_OR_OTHER|||||||0.4754|||||||Kruskal-Wallis|||||||0.4754
71107192|NCT00163293|141720731|SUPERIORITY_OR_OTHER|||||||0.6844|||||||Kruskal-Wallis|||||||0.6844
71107193|NCT03366454|141720776|OTHER||AUC|0.6692|STANDARD_ERROR_OF_MEAN|0.05322||0.0048|TWO_SIDED|95.0|0.5649|0.7735|||ROC Curve Analysis|||ROC curve analysis was performed to evaluate outcome. The Area Under the Curve (AUC) was calculated along with a 95% confidence interval and statistical significance (p-value)||0.7735|0.5649|0.0048
71107194|NCT03366454|141720776|OTHER||AUC|0.6892|STANDARD_ERROR_OF_MEAN|0.05213||0.0029|TWO_SIDED|95.0|0.587|0.7914|||ROC Curve Analysis|||ROC curve analysis was performed to evaluate outcome. The Area Under the Curve (AUC) was calculated along with a 95% confidence interval and statistical significance (p-value).||0.7914|0.5870|0.0029
70851424|NCT03495856|141190734|OTHER|within-group paired t-test|Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|0.37||0.05|TWO_SIDED|95.0|-1.55|0.0||The a priori threshold for statistical significance was p less than or equal to 0.05. That calculated p-value in the statistical hypothesis test was equal to 0.05.|t-test, 2 sided|||||0.00|-1.55|0.05
70933420|NCT03926026|141367952|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.0471|TWO_SIDED|95.0|-1.5|0.0|||t-test, 2 sided|||||0|-1.5|0.0471
71022278|NCT02273206|141552448|SUPERIORITY|||||||0.91|||||||Chi-squared|||Ambulatory Care Experiences - Access at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.91
70851425|NCT03495856|141190735|OTHER|within-group paired t-test|Mean Difference (Final Values)|-3.67|STANDARD_ERROR_OF_MEAN|1.42||0.017|TWO_SIDED|95.0|-6.63|-0.71|||t-test, 2 sided|||||-0.71|-6.63|0.017
71022279|NCT02273206|141552448|SUPERIORITY|||||||0.69|||||||Chi-squared|||Ambulatory Care Experiences - Access at six months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.69
71022280|NCT02273206|141552448|SUPERIORITY|||||||0.63|||||||Chi-squared|||Ambulatory Care Experiences - Access at twelve months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.63
71022281|NCT02273206|141552448|SUPERIORITY|||||||0.55|||||||Chi-squared|||Ambulatory Care Experiences - Care Coordination at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.55
71022282|NCT02273206|141552448|SUPERIORITY|||||||0.34|||||||Chi-squared|||Ambulatory Care Experiences - Care Coordination at six months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.34
71022283|NCT02273206|141552448|SUPERIORITY|||||||0.19|||||||Chi-squared|||Ambulatory Care Experiences - Care Coordination at twelve months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.19
71022284|NCT02273206|141552448|SUPERIORITY|||||||0.47|||||||Chi-squared|||Ambulatory Care Experiences - Quality at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.47
71022285|NCT02273206|141552448|SUPERIORITY|||||||0.38|||||||Chi-squared|||Ambulatory Care Experiences - Quality at six months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.38
71022286|NCT02273206|141552448|SUPERIORITY|||||||0.98|||||||Chi-squared|||Ambulatory Care Experiences - Quality at twelve months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.98
71022287|NCT02273206|141552449|SUPERIORITY|||||||0.78|||||||Chi-squared|||Medication Adherence at baseline. Coding of the measure was based on Morisky et al. (2008).||||0.78
71022288|NCT02273206|141552449|SUPERIORITY|||||||0.2|||||||Chi-squared|||Medication Adherence at 6 months. Coding of the measure was based on Morisky et al. (2008).||||0.20
71022289|NCT02273206|141552449|SUPERIORITY|||||||0.77|||||||Chi-squared|||Medication Adherence at 12 Months. Coding of the measure was based on Morisky et al. (2008).||||0.77
71022290|NCT02273206|141552450|SUPERIORITY|||||||0.7|||||||Chi-squared|||Self-efficacy at baseline.Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.70
71022291|NCT02273206|141552450|SUPERIORITY|||||||0.89|||||||Chi-squared|||Self-efficacy at 6 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.89
71022292|NCT02273206|141552450|SUPERIORITY|||||||0.95|||||||Chi-squared|||Self-efficacy at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.95
71022293|NCT00373685|141552452|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|TWO_SIDED|||||Life Table Extension of Cochran-Mantel-Haenszel (CMH) Test|Life Table Extension of CMH Test|||||||0.0003
71022294|NCT00373685|141552453|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0035|TWO_SIDED||||||Life Table Extension of CMH Test|||||||0.0035
71022295|NCT00373685|141552454|SUPERIORITY_OR_OTHER_LEGACY|||||||0.614|TWO_SIDED||||||Life Table Extension of CMH Test|||||||0.6140
71022296|NCT00373685|141552456|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||P-value associated with Overall (LOCF)|ANCOVA|||||||<0.0001
71022297|NCT00373685|141552458|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||P-value associated with Overall (LOCF)|ANCOVA|||||||<0.0001
71022298|NCT00373685|141552459|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0023|TWO_SIDED|||||P-value associated with Overall (LOCF)|Cochran-Mantel-Haenszel|||||||0.0023
71022299|NCT00373685|141552460|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1008|TWO_SIDED||||||Chi-squared|||Baseline||||0.1008
71022300|NCT00373685|141552460|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 8||||<0.0001
71022301|NCT00373685|141552460|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 16||||<0.0001
71022302|NCT00373685|141552460|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005|TWO_SIDED||||||Chi-squared|||Week 24 or ET||||0.0005
71022303|NCT00373685|141552460|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 24/LOCF||||<0.0001
71022304|NCT00373685|141552461|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6562|TWO_SIDED||||||Chi-squared|||Baseline||||0.6562
71022305|NCT00373685|141552461|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 8||||<0.0001
71022306|NCT00373685|141552461|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 16||||<0.0001
71022307|NCT00373685|141552461|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0245|TWO_SIDED||||||Chi-squared|||Week 24 or ET||||0.0245
71022308|NCT00373685|141552461|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0074|TWO_SIDED||||||Chi-squared|||Week 24/LOCF||||0.0074
71022309|NCT00373685|141552462|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4074|TWO_SIDED||||||Chi-squared|||Baseline||||0.4074
71022310|NCT00373685|141552462|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 8||||<0.0001
71022311|NCT00373685|141552462|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 16||||<0.0001
71022312|NCT00373685|141552462|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0127|TWO_SIDED||||||Chi-squared|||Week 24 or ET||||0.0127
71022313|NCT00373685|141552462|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019|TWO_SIDED||||||Chi-squared|||Week 24/LOCF||||0.0019
71022314|NCT00373685|141552463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2699|TWO_SIDED||||||Chi-squared|||Baseline||||0.2699
71022315|NCT00373685|141552463|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 8||||<0.0001
71022316|NCT00373685|141552463|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 16||||<0.0001
71022317|NCT00373685|141552463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0027|TWO_SIDED||||||Chi-squared|||Week 24 or ET||||0.0027
71107195|NCT03366454|141720777|OTHER||AUC|0.644|STANDARD_ERROR_OF_MEAN|0.05635||0.0233|TWO_SIDED|95.0|0.5335|0.7544|||ROC Curve Analysis||The optimal cutoff value for NLR was determined as 1.335 using the Youden Index.|ROC curve analysis was performed to evaluate outcome. The Area Under the Curve (AUC) was calculated along with a 95% confidence interval and statistical significance (p-value).||0.7544|0.5335|0.0233
71107196|NCT03366454|141720778|OTHER||AUC|0.6884|STANDARD_ERROR_OF_MEAN|0.04709||0.0018|TWO_SIDED|95.0|0.5962|0.7807|||ROC Curve Analysis||The optimal cut-off value for CRP was determined as 5.70 using the Youden Index.|ROC curve analysis was performed to evaluate outcome. The Area Under the Curve (AUC) was calculated along with a 95% confidence interval and statistical significance (p-value)||0.7807|0.5962|0.0018
71107197|NCT03366454|141720779|OTHER||AUC|0.7063|STANDARD_ERROR_OF_MEAN|0.04857||0.0007|TWO_SIDED|95.0|0.6111|0.8015|||ROC Curve Analysis||The optimal cutoff value for PCT was determined as 0.141 using the Youden Index.|ROC curve analysis was performed to evaluate outcome. The Area Under the Curve (AUC) was calculated along with a 95% confidence interval and statistical significance (p-value).||0.8015|0.6111|0.0007
71107198|NCT01732536|141720799|SUPERIORITY|||||||0.1365|||||||ANCOVA|Based on between group comparison using ANCOVA model with baseline as a covariate and site and treatment as fixed effects||||||0.1365
71107199|NCT01732536|141720799|SUPERIORITY|||||||0.0505||||||Based on between group comparison using ANCOVA model with baseline as a covariate and site and treatment as fixed effects|ANCOVA|||The change from baseline to Day 90 in Nasal Obstruction/Congestion score in the subset of participants with higher polyp burden at baseline (grade 2 or higher polyps on each side; N=67).||||0.0505
71107200|NCT01732536|141720800|SUPERIORITY|||||||0.0985|||||||ANCOVA|Based on ANCOVA model with baseline as a covariate, site and treatment as fixed effect||||||0.0985
71107201|NCT01732536|141720800|SUPERIORITY|||||||0.049|||||||ANOVA|Based on ANCOVA model with baseline as a covariate, site and treatment as fixed effect||Bilateral polyp grade change in a subset of 67 patients with higher polyp burden at baseline (grade 2 or higher on each side confirmed by the independent panel)||||0.0490
70851426|NCT03495856|141190736|OTHER|Within-group paired t-test|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.7||0.938|TWO_SIDED|95.0|-1.39|1.5|||t-test, 2 sided|||||1.50|-1.39|0.938
71022318|NCT00373685|141552463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|TWO_SIDED||||||Chi-squared|||Week 24/LOCF||||0.0001
71022319|NCT00362401|141552473|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||The comparison of the three valve groups with respect to the objective sound measures was made by the one-way ANOVA method. The null hypothesis is that there is no difference on intensity of heart valve sounds among the three groups.||||<0.05
71107202|NCT01732536|141720801|SUPERIORITY|||||||0.0099|||||||ANCOVA|||||||0.0099
71107203|NCT01732536|141720802|SUPERIORITY|||||||0.0162||||||P-value for change from baseline to 90 days not adjusted for multiplicity|ANCOVA|ANCOVA model with baseline as a covariate and site and treatment as fixed effects||||||0.0162
71107204|NCT01732536|141720802|SUPERIORITY|||||||0.0175||||||P-value for change from baseline to 6 months not adjusted for multiplicity|ANCOVA|ANCOVA model with baseline as a covariate and site and treatment as fixed effects||||||0.0175
71107205|NCT01732536|141720803|SUPERIORITY|||||||0.0209||||||P-value not adjusted for multiplicity.|ANCOVA|Based on between arm comparison using ANCOVA model with baseline as a covariate and site and treatment as fixed effects||||||0.0209
71107206|NCT03235050|141720834|SUPERIORITY||LS Mean Difference|-0.83|||<|0.001|TWO_SIDED|95.0|-1.06|-0.59|||ANCOVA|||||-0.59|-1.06|<0.001
71107207|NCT03235050|141720834|SUPERIORITY||LS Mean Difference|-1.04|||<|0.001|TWO_SIDED|95.0|-1.23|-0.85|||ANCOVA|||||-0.85|-1.23|<0.001
71107208|NCT03235050|141720834|SUPERIORITY||LS Mean Difference|-0.91|||<|0.001|TWO_SIDED|95.0|-1.11|-0.72|||ANCOVA|||||-0.72|-1.11|<0.001
70851427|NCT03495856|141190737|OTHER|Within-group paired t-test|Mean Difference (Final Values)|-3.34|STANDARD_ERROR_OF_MEAN|1.05||0.005|TWO_SIDED|95.0|-5.53|-1.15||The a priori threshold for statistical significance was p less than or equal to 0.05.|t-test, 2 sided|||||-1.15|-5.53|0.005
71022320|NCT00769015|141552482|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.54||||0.067|TWO_SIDED|95.0|0.27|1.06||Mantel-Haenszel chi-square test. The p-value refers to the overall test of between group differences in rates of depression.|Mantel Haenszel|||||1.06|.27|.067
71022321|NCT00769015|141552483|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.81||||0.75|TWO_SIDED|95.0|-5.92|4.3|||Linear Mixed effects model|||||4.30|-5.92|.75
71022322|NCT00769015|141552484|SUPERIORITY_OR_OTHER||Change in least squares mean|3.47||||0.68|TWO_SIDED|95.0|-12.22|5.29|||Mixed Models Analysis|||||5.29|-12.22|.68
71107209|NCT03235050|141720835|SUPERIORITY||LS Mean Difference|-2.0|||<|0.001|TWO_SIDED|95.0|-3.08|-0.91|||ANCOVA|||||-0.91|-3.08|<0.001
71107210|NCT03235050|141720835|SUPERIORITY||LS Mean Difference|-2.76|||<|0.001|TWO_SIDED|95.0|-3.65|-1.87|||ANCOVA|||||-1.87|-3.65|<0.001
71107211|NCT03235050|141720835|SUPERIORITY||LS Mean Difference|-3.62|||<|0.001|TWO_SIDED|95.0|-4.51|-2.73|||ANCOVA|||||-2.73|-4.51|<0.001
71107212|NCT03235050|141720836|SUPERIORITY||LS Mean Difference|-0.66|||<|0.001|TWO_SIDED|95.0|-0.92|-0.4|||ANCOVA|||Week 26||-0.40|-0.92|<0.001
71107213|NCT03235050|141720836|SUPERIORITY||LS Mean Difference|-0.81|||<|0.001|TWO_SIDED|95.0|-1.03|-0.6|||ANCOVA|||Week 26||-0.60|-1.03|<0.001
71107214|NCT03235050|141720836|SUPERIORITY||LS Mean Difference|-0.72|||<|0.001|TWO_SIDED|95.0|-0.94|-0.51|||ANCOVA|||Week 26||-0.51|-0.94|<0.001
71107215|NCT03235050|141720836|SUPERIORITY||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.8|-0.24|||ANCOVA|||Week 54||-0.24|-0.80|<0.001
71107216|NCT03235050|141720836|SUPERIORITY||LS Mean Difference|-0.63|||<|0.001|TWO_SIDED|95.0|-0.86|-0.39|||ANCOVA|||Week 54||-0.39|-0.86|<0.001
71107217|NCT03235050|141720836|SUPERIORITY||LS Mean Difference|-0.57|||<|0.001|TWO_SIDED|95.0|-0.8|-0.34|||ANCOVA|||Week 54||-0.34|-0.80|<0.001
71107218|NCT03235050|141720837|SUPERIORITY||Odds Ratio, log|6.67|||<|0.001|TWO_SIDED|92.0|3.34|13.3|||Regression, Logistic|||Week 14||13.30|3.34|<0.001
71107219|NCT03235050|141720837|SUPERIORITY||Odds Ratio, log|9.95|||<|0.001|TWO_SIDED|95.0|5.39|18.36|||Regression, Logistic|||Week 14||18.36|5.39|<0.001
71107220|NCT03235050|141720837|SUPERIORITY||Odds Ratio, log|8.52|||<|0.001|TWO_SIDED|95.0|4.65|15.61|||Regression, Logistic|||Week 14||15.61|4.65|<0.001
71107221|NCT03235050|141720837|SUPERIORITY||Odds Ratio, log|3.74|||<|0.001|TWO_SIDED|95.0|1.98|7.03|||Regression, Logistic|||Week 26||7.03|1.98|<0.001
71107222|NCT03235050|141720837|SUPERIORITY||Odds Ratio, log|5.4|||<|0.001|TWO_SIDED|95.0|3.13|9.34|||Regression, Logistic|||Week 26||9.34|3.13|<0.001
71107223|NCT03235050|141720837|SUPERIORITY||Odds Ratio, log|5.2|||<|0.001|TWO_SIDED|95.0|3.02|8.97|||Regression, Logistic|||Week 26||8.97|3.02|<0.001
70933421|NCT02824198|141367956|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval (CI) of the Geometric mean of titer ratios (GMTRs) (booster vs post-dose 3) was greater than (\>) 1/2 for each serotype.|Geometric mean of titer ratio|1.34|||||TWO_SIDED|95.0|0.998|1.79||||||Dengue Virus Serotype 1||1.79|0.998|
71022323|NCT00769015|141552485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.42||||0.34|TWO_SIDED|95.0|-2.58|7.41|||Least squares mean|||||7.41|-2.58|.34
71107224|NCT03235050|141720837|SUPERIORITY||Odds Ratio, log|4.94|||<|0.001|TWO_SIDED|95.0|2.61|9.36|||Regression, Logistic|||Week 54||9.36|2.61|<0.001
71107225|NCT03235050|141720837|SUPERIORITY||Odds Ratio, log|4.55|||<|0.001|TWO_SIDED|95.0|2.62|7.89|||Regression, Logistic|||Week 54||7.89|2.62|<0.001
71107226|NCT03235050|141720837|SUPERIORITY||Odds Ratio, log|4.34|||<|0.001|TWO_SIDED|95.0|2.51|7.51|||Regression, Logistic|||Week 54||7.51|2.51|<0.001
71107227|NCT03235050|141720838|SUPERIORITY||LS Mean Difference|-2.09|||<|0.001|TWO_SIDED|95.0|-3.32|-0.85|||ANCOVA|||Week 26||-0.85|-3.32|<0.001
71107228|NCT03235050|141720838|SUPERIORITY||LS Mean Difference|-2.8|||<|0.001|TWO_SIDED|95.0|-3.82|-1.79|||ANCOVA|||Week 26||-1.79|-3.82|<0.001
71107229|NCT03235050|141720838|SUPERIORITY||LS Mean Difference|-3.46|||<|0.001|TWO_SIDED|95.0|-4.48|-2.44|||ANCOVA|||Week 26||-2.44|-4.48|<0.001
71107230|NCT03235050|141720838|SUPERIORITY||LS Mean Difference|-2.43|||<|0.001|TWO_SIDED|95.0|-3.86|-1.0|||ANCOVA|||Week 54||-1.00|-3.86|<0.001
71107231|NCT03235050|141720838|SUPERIORITY||LS Mean Difference|-2.24|||<|0.001|TWO_SIDED|95.0|-3.41|-1.06|||ANCOVA|||Week 54||-1.06|-3.41|<0.001
71107232|NCT03235050|141720838|SUPERIORITY||LS Mean Difference|-3.32|||<|0.001|TWO_SIDED|95.0|-4.49|-2.14|||ANCOVA|||Week 54||-2.14|-4.49|<0.001
70933422|NCT02824198|141367956|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was \> 1/2 for each serotype.|Geometric mean of titer ratio|0.603|||||TWO_SIDED|95.0|0.439|0.829||||||Dengue Virus Serotype 2||0.829|0.439|
71022324|NCT00769015|141552486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.02||||0.68|TWO_SIDED|95.0|-9.8|5.76|||Least squares mean|||||5.76|-9.80|.68
71107233|NCT03235050|141720839|SUPERIORITY||LS Mean Difference|-1.95|||<|0.001|TWO_SIDED|95.0|-3.03|-0.87|||ANCOVA|||Week 14||-0.87|-3.03|<0.001
71107234|NCT03235050|141720839|SUPERIORITY||LS Mean Difference|-2.75|||<|0.001|TWO_SIDED|95.0|-3.63|-1.86|||ANCOVA|||Week 14||-1.86|-3.63|<0.001
71107235|NCT03235050|141720839|SUPERIORITY||LS Mean Difference|-3.71|||<|0.001|TWO_SIDED|95.0|-4.6|-2.82|||ANCOVA|||Week 14||-2.82|-4.60|<0.001
71107236|NCT03235050|141720839|SUPERIORITY||LS Mean Difference|-2.01||||0.002|TWO_SIDED|95.0|-3.27|-0.74|||ANCOVA|||Week 26||-0.74|-3.27|0.002
71107237|NCT03235050|141720839|SUPERIORITY||LS Mean Difference|-2.74|||<|0.001|TWO_SIDED|95.0|-3.78|-1.71|||ANCOVA|||Week 26||-1.71|-3.78|<0.001
71107238|NCT03235050|141720839|SUPERIORITY||LS Mean Difference|-3.55|||<|0.001|TWO_SIDED|95.0|-4.59|-2.52|||ANCOVA|||Week 26||-2.52|-4.59|<0.001
71107239|NCT03235050|141720839|SUPERIORITY||LS Mean Difference|-2.27||||0.003|TWO_SIDED|95.0|-3.74|-0.79|||ANCOVA|||Week 54||-0.79|-3.74|0.003
71107240|NCT03235050|141720839|SUPERIORITY||LS Mean Difference|-2.16|||<|0.001|TWO_SIDED|95.0|-3.37|-0.95|||ANCOVA|||Week 54||-0.95|-3.37|<0.001
71107241|NCT03235050|141720839|SUPERIORITY||LS Mean Difference|-3.42|||<|0.001|TWO_SIDED|95.0|-4.63|-2.2|||ANCOVA|||Week 54||-2.20|-4.63|<0.001
71107242|NCT03235050|141720840|SUPERIORITY||LS Mean Difference|0.7||||0.211|TWO_SIDED|95.0|-0.39|1.79|||ANCOVA|||Percent change at Week 14||1.79|-0.39|0.211
71107243|NCT03235050|141720840|SUPERIORITY||LS Mean Difference|-0.07||||0.881|TWO_SIDED|95.0|-0.96|0.83|||ANCOVA|||Percent change at Week 14||0.83|-0.96|0.881
71022325|NCT00769015|141552487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39||||0.68|TWO_SIDED|95.0|-4.04|6.82|||Least squares mean|||||6.82|-4.04|.68
71022326|NCT00769015|141552488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.62||||0.68|TWO_SIDED|95.0|-5.94|9.17|||Least squares mean|||||9.17|-5.94|.68
71107244|NCT03235050|141720840|SUPERIORITY||LS Mean Difference|-0.93||||0.042|TWO_SIDED|95.0|-1.82|-0.04|||ANCOVA|||Percent change at Week 14||-0.04|-1.82|0.042
70933423|NCT02824198|141367956|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was \> 1/2 for each serotype.|Geometric mean of titer ratio|0.979|||||TWO_SIDED|95.0|0.746|1.28||||||Dengue Virus Serotype 3||1.28|0.746|
71107245|NCT03235050|141720840|SUPERIORITY||LS Mean Difference|0.9||||0.158|TWO_SIDED|95.0|-0.35|2.14|||ANCOVA|||Percent change at Week 26||2.14|-0.35|0.158
71107246|NCT03235050|141720840|SUPERIORITY||LS Mean Difference|0.18||||0.734|TWO_SIDED|95.0|-0.85|1.2|||ANCOVA|||Percent change at Week 26||1.20|-0.85|0.734
71107247|NCT03235050|141720840|SUPERIORITY||LS Mean Difference|-0.48||||0.357|TWO_SIDED|95.0|-1.51|0.54|||ANCOVA|||Percent change at Week 26||0.54|-1.51|0.357
71107248|NCT03235050|141720840|SUPERIORITY||LS Mean Difference|-0.07||||0.921|TWO_SIDED|95.0|-1.51|1.37|||ANCOVA|||Percent change at Week 54||1.37|-1.51|0.921
71107249|NCT03235050|141720840|SUPERIORITY||LS Mean Difference|0.12||||0.847|TWO_SIDED|95.0|-1.07|1.3|||ANCOVA|||Percent change at Week 54||1.30|-1.07|0.847
71107250|NCT03235050|141720840|SUPERIORITY||LS Mean Difference|-0.96||||0.112|TWO_SIDED|95.0|-2.15|0.22|||ANCOVA|||Percent change at Week 54||0.22|-2.15|0.112
71107251|NCT03235050|141720841|SUPERIORITY||LS Mean Difference|0.59||||0.284|TWO_SIDED|95.0|-0.49|1.68|||ANCOVA|||Absolute change at Week 14||1.68|-0.49|0.284
71107252|NCT03235050|141720841|SUPERIORITY||LS Mean Difference|-0.2||||0.658|TWO_SIDED|95.0|-1.09|0.69|||ANCOVA|||Absolute change at Week 14||0.69|-1.09|0.658
71107253|NCT03235050|141720841|SUPERIORITY||LS Mean Difference|-1.17||||0.01|TWO_SIDED|95.0|-2.06|-0.27|||ANCOVA|||Absolute change at Week 14||-0.27|-2.06|0.010
71107254|NCT03235050|141720841|SUPERIORITY||LS Mean Difference|0.7||||0.279|TWO_SIDED|95.0|-0.57|1.97|||ANCOVA|||Absolute change at Week 26||1.97|-0.57|0.279
71107255|NCT03235050|141720841|SUPERIORITY||LS Mean Difference|-0.04||||0.94|TWO_SIDED|95.0|-1.08|1.0|||ANCOVA|||Absolute change at Week 26||1.00|-1.08|0.940
70933424|NCT02824198|141367956|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was \> 1/2 for each serotype.|Geometric mean of titer ratio|1.27|||||TWO_SIDED|95.0|0.918|1.75||||||Dengue Virus Serotype 4||1.75|0.918|
70933425|NCT01613417|141367997|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation was based on primary endpoint. 185 patients were deemed necessary for the lower limit of the observed 2-sided 95% confidence interval for the difference to exceed -5% with 85% power.|Percentage PH better minus GV better|0.5||||0.8516|TWO_SIDED|95.0|-4.6|5.6||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)||Difference in percentage ProHance better minus percentage Gadovist/Gadavist better (%)|||5.6|-4.6|0.8516
71022327|NCT04288115|141552568|NON_INFERIORITY|An one-sided α-level of 0.05 will be used to determine the statistical significance of the non-inferiority test.|Difference in Group Means|-5.3||||0.0913|TWO_SIDED|90.0|-16.1|5.4||Group differences.|Welch's two-sample t-test|A one-sided p-value \< 0.05 indicates the discontinuation mean falls within the non-inferiority limit.|Differences reported as the sham discontinuation mean minus the real discontinuation mean.|A one-sided t-test will be used to determine whether the mean Hypothyroid Symptoms score for the real discontinuation group is no more than 14 points worse than the score of the sham discontinuation group at 6 months.||5.4|-16.1|0.0913
71055487|NCT00761657|141615020|OTHER||||||<|0.0001||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||<0.0001
71055488|NCT00270855|141615040|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group (i.e, baseline vs. post-intervention in ARE)||||>0.05
71055489|NCT00270855|141615040|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group (i.e, baseline vs. post-intervention in FESLCE)||||>0.05
71055490|NCT00270855|141615041|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
71055491|NCT00270855|141615041|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
71055492|NCT00270855|141615042|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.||||||0.519|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group.||||0.519
71055493|NCT00270855|141615042|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
71055494|NCT00270855|141615043|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.||||||0.615|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||0.615
71055495|NCT00270855|141615043|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
71055496|NCT00270855|141615044|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
71055497|NCT00270855|141615044|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
71055498|NCT00270855|141615045|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
71055499|NCT00270855|141615046|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
71055500|NCT00270855|141615047|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
71055501|NCT00270855|141615048|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
71055502|NCT00270855|141615049|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
71055503|NCT00270855|141615050|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
71055504|NCT00270855|141615050|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
71055505|NCT00270855|141615051|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
71055506|NCT00270855|141615051|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
71055507|NCT00270855|141615052|NON_INFERIORITY_OR_EQUIVALENCE|Wilcoxon signed-rank test was performed|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
71107256|NCT03235050|141720841|SUPERIORITY||LS Mean Difference|-0.85||||0.11|TWO_SIDED|95.0|-1.89|0.19|||ANCOVA|||Absolute change at Week 26||0.19|-1.89|0.110
71107257|NCT03235050|141720841|SUPERIORITY||LS Mean Difference|-0.26||||0.73|TWO_SIDED|95.0|-1.74|1.22|||ANCOVA|||Absolute change at Week 54||1.22|-1.74|0.730
71107258|NCT03235050|141720841|SUPERIORITY||LS Mean Difference|-0.15||||0.804|TWO_SIDED|95.0|-1.38|1.07|||ANCOVA|||Absolute change at Week 54||1.07|-1.38|0.804
71107259|NCT03235050|141720841|SUPERIORITY||LS Mean Difference|-1.41||||0.023|TWO_SIDED|95.0|-2.63|-0.19|||ANCOVA|||Absolute change at Week 54||-0.19|-2.63|0.023
71107260|NCT03235050|141720842|SUPERIORITY||Odds Ratio, log|8.37|||<|0.001|TWO_SIDED|95.0|2.38|29.43|||Regression, Logistic|||weight loss \>=5% at Week 14||29.43|2.38|<0.001
71107261|NCT03235050|141720842|SUPERIORITY||Odds Ratio, log|12.46|||<|0.001|TWO_SIDED|95.0|3.82|40.64|||Regression, Logistic|||weight loss \>=5% at Week 14||40.64|3.82|<0.001
71107262|NCT03235050|141720842|SUPERIORITY||Odds Ratio, log|21.26|||<|0.001|TWO_SIDED|95.0|6.55|68.97|||Regression, Logistic|||weight loss \>=5% at Week 14||68.97|6.55|<0.001
71107263|NCT03235050|141720842|SUPERIORITY||Odds Ratio, log|3.68|||<|0.001|TWO_SIDED|95.0|1.72|7.89|||Regression, Logistic|||weight loss \>=5% at Week 26||7.89|1.72|<0.001
71107264|NCT03235050|141720842|SUPERIORITY||Odds Ratio, log|3.95|||<|0.001|TWO_SIDED|95.0|2.0|7.78|||Regression, Logistic|||weight loss \>=5% at Week 26||7.78|2.00|<0.001
71107265|NCT03235050|141720842|SUPERIORITY||Odds Ratio, log|7.28|||<|0.001|TWO_SIDED|95.0|3.72|14.24|||Regression, Logistic|||weight loss \>=5% at Week 26||14.24|3.72|<0.001
71107266|NCT03235050|141720842|SUPERIORITY||Odds Ratio, log|3.71|||<|0.001|TWO_SIDED|95.0|1.84|7.45|||Regression, Logistic|||weight loss \>=5% at Week 54||7.45|1.84|<0.001
71107267|NCT03235050|141720842|SUPERIORITY||Odds Ratio, log|2.73||||0.002|TWO_SIDED|95.0|1.46|5.09|||Regression, Logistic|||weight loss \>=5% at Week 54||5.09|1.46|0.002
71107268|NCT03235050|141720842|SUPERIORITY||Odds Ratio, log|4.48|||<|0.001|TWO_SIDED|95.0|2.42|8.3|||ANCOVA|||weight loss \>=5% at Week 54||8.30|2.42|<0.001
71107269|NCT03235050|141720842|SUPERIORITY||Odds Ratio, log|8.47||||0.048|TWO_SIDED|95.0|1.02|70.17|||Regression, Logistic|||weight loss \>=10% at Week 26||70.17|1.02|0.048
71107270|NCT03235050|141720842|SUPERIORITY||Odds Ratio, log|13.81||||0.01|TWO_SIDED|95.0|1.85|102.91|||Regression, Logistic|||weight loss \>=10% at Week 26||102.91|1.85|0.010
71107271|NCT03235050|141720842|SUPERIORITY||Odds Ratio, log|13.09||||0.012|TWO_SIDED|95.0|1.75|97.68|||Regression, Logistic|||weight loss \>=10% at Week 26||97.68|1.75|0.012
71107272|NCT03235050|141720842|SUPERIORITY||Odds Ratio, log|6.92||||0.013|TWO_SIDED|95.0|1.49|32.07|||Regression, Logistic|||weight loss \>=10% at Week 54||32.07|1.49|0.013
71107273|NCT03235050|141720842|SUPERIORITY||Odds Ratio, log|4.98||||0.032|TWO_SIDED|95.0|1.15|21.6|||Regression, Logistic|||weight loss \>=10% at Week 54||21.60|1.15|0.032
71107274|NCT03235050|141720842|SUPERIORITY||Odds Ratio, log|7.91||||0.005|TWO_SIDED|95.0|1.86|33.64|||Regression, Logistic|||weight loss \>=10% at Week 54||33.64|1.86|0.005
71107275|NCT03235050|141720843|SUPERIORITY||Odds Ratio, log|0.09||||0.024|TWO_SIDED|95.0|0.01|0.73|||Regression, Logistic|||received rescue medication at 14 wks||0.73|0.01|0.024
71107276|NCT03235050|141720843|SUPERIORITY||Odds Ratio, log|0.11|||<|0.001|TWO_SIDED|95.0|0.03|0.4|||Regression, Logistic|||received rescue medication at 14 wks||0.40|0.03|<0.001
71107277|NCT03235050|141720843|SUPERIORITY||Odds Ratio, log|0.07|||<|0.001|TWO_SIDED|95.0|0.02|0.33|||Regression, Logistic|||received rescue medication at 14 wks||0.33|0.02|<0.001
71107278|NCT03235050|141720843|SUPERIORITY||Odds Ratio, log|0.14||||0.002|TWO_SIDED|95.0|0.04|0.48|||Regression, Logistic|||received rescue medication at 26 wks||0.48|0.04|0.002
71107279|NCT03235050|141720843|SUPERIORITY||Odds Ratio, log|0.14|||<|0.001|TWO_SIDED|95.0|0.06|0.34|||Regression, Logistic|||received rescue medication at 26 wks||0.34|0.06|<0.001
71107280|NCT03235050|141720843|SUPERIORITY||Odds Ratio, log|0.11|||<|0.001|TWO_SIDED|95.0|0.04|0.28|||Regression, Logistic|||received rescue medication at 26 wks||0.28|0.04|<0.001
71107281|NCT03235050|141720843|SUPERIORITY||Odds Ratio, log|0.24|||<|0.001|TWO_SIDED|95.0|0.11|0.53|||Regression, Logistic|||received rescue medication at 54 wks||0.53|0.11|<0.001
71107282|NCT03235050|141720843|SUPERIORITY||Odds Ratio, log|0.24|||<|0.001|TWO_SIDED|95.0|0.13|0.44|||Regression, Logistic|||received rescue medication at 54 wks||0.44|0.13|<0.001
71107283|NCT03235050|141720843|SUPERIORITY||Odds Ratio, log|0.22|||<|0.001|TWO_SIDED|95.0|0.12|0.41|||Regression, Logistic|||received rescue medication at 54 wks||0.41|0.12|<0.001
71107284|NCT03235050|141720843|SUPERIORITY||Odds Ratio, log|0.22||||0.216|TWO_SIDED|95.0|0.02|2.43|||Regression, Logistic|||discontinued IP at 14 wks||2.43|0.02|0.216
71107285|NCT03235050|141720843|SUPERIORITY||Odds Ratio, log|0.28||||0.253|TWO_SIDED|95.0|0.03|2.52|||Regression, Logistic|||discontinued IP at 26 wks||2.52|0.03|0.253
71107286|NCT03235050|141720843|SUPERIORITY||Odds Ratio, log|0.21||||0.079|TWO_SIDED|95.0|0.04|1.19|||Regression, Logistic|||discontinued IP at 26 wks||1.19|0.04|0.079
71107287|NCT03235050|141720843|SUPERIORITY||Odds Ratio, log|0.27||||0.252|TWO_SIDED|95.0|0.03|2.5|||Regression, Logistic|||discontinued IP at 54 wks||2.50|0.03|0.252
71107288|NCT03235050|141720843|SUPERIORITY||Odds Ratio, log|0.32||||0.143|TWO_SIDED|95.0|0.07|1.47|||Regression, Logistic|||discontinued IP at 54 wks||1.47|0.07|0.143
71107289|NCT03545672|141720847|SUPERIORITY|||||||0.001||||||The threshold for statistical significance was p=0.05|Chi-squared|||||||0.001
71107290|NCT03545672|141720848|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71117620|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
71117621|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
70851428|NCT03495856|141190738|OTHER|Within-group paired t-test|Mean Difference (Final Values)|-2.21|STANDARD_ERROR_OF_MEAN|1.38||0.124|TWO_SIDED|95.0|-5.09|0.66|||t-test, 2 sided|||||0.66|-5.09|0.124
70851429|NCT03495856|141190739|OTHER|Within-group paired t-test|Mean Difference (Final Values)|-4.69|STANDARD_ERROR_OF_MEAN|1.26||0.001|TWO_SIDED|95.0|-7.3|-2.07|||t-test, 2 sided|||||-2.07|-7.30|0.001
70851430|NCT03495856|141190740|OTHER|Within-group paired t-test|Mean Difference (Final Values)|-1.27|STANDARD_ERROR_OF_MEAN|0.5||0.018|TWO_SIDED|95.0|-2.31|-0.24|||t-test, 2 sided|||||-0.24|-2.31|0.018
70851431|NCT03495856|141190741|OTHER|Within-group paired t-test|Mean Difference (Final Values)|2.79|STANDARD_ERROR_OF_MEAN|1.07||0.016|TWO_SIDED|95.0|0.58|5.01|||t-test, 2 sided|||||5.01|0.58|0.016
70941654|NCT04748445|141383934|OTHER||Slope|1.821|STANDARD_ERROR_OF_MEAN|1.028||0.0791|TWO_SIDED|90.0|1.166|3.524|||Mixed Models Analysis|||MM\_MFCC mean 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-1. For lower limit it was 10\^-2).||3.524|1.166|0.0791
71055508|NCT00270855|141615052|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
71055509|NCT00270855|141615053|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
71055510|NCT00270855|141615053|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
70851432|NCT03495856|141190742|OTHER|Within-group paired t-test|Mean Difference (Final Values)|-4.96|STANDARD_ERROR_OF_MEAN|1.41||0.002|TWO_SIDED|95.0|-7.88|-2.03|||t-test, 2 sided|||||-2.03|-7.88|0.002
71055511|NCT00270855|141615054|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
71055512|NCT00270855|141615054|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
71055513|NCT00270855|141615055|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
71055514|NCT00270855|141615055|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
71055515|NCT00270855|141615056|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
71055516|NCT00270855|141615056|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
71055517|NCT00270855|141615057|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
71055518|NCT00270855|141615058|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
71055519|NCT00270855|141615059|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
71055520|NCT00270855|141615060|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
71055521|NCT00270855|141615061|OTHER|A Mann-Whitney U test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
71055522|NCT00270855|141615062|NON_INFERIORITY_OR_EQUIVALENCE|We used a Mann-Whitney U test.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||we evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
71055523|NCT00270855|141615063|NON_INFERIORITY_OR_EQUIVALENCE|A mann-whitney u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
71055524|NCT00270855|141615064|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
71055525|NCT00270855|141615064|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
71055526|NCT00270855|141615065|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney U test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
71055527|NCT02152605|141615078|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.03|||<|0.001|TWO_SIDED|95.0|-6.28|-1.79|||Mixed Models Analysis|||||-1.79|-6.28|<0.001
70851433|NCT03495856|141190743|OTHER|Within-group paired t-test|Mean Difference (Final Values)|13.27|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|8.47|18.07|||t-test, 2 sided|||||18.07|8.47|<0.001
70851434|NCT03495856|141190744|OTHER|Within-group paired t-test|Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|1.96||0.001|TWO_SIDED|95.0|3.92|12.08|||t-test, 2 sided|||||12.08|3.92|0.001
70851435|NCT00435045|141190745|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the non-HDL-C response was assessed by calculating the 2-sided 90% and 95% confidence intervals (CIs)for each difference in response based on comparing the effects of increases in atorvastatin dose on the percent changes from baseline to the end of each atorvastatin period, a repeated-ANOVA model was used.||||||0.0002||95.0|||||ANOVA|||||||0.0002
70933426|NCT01613417|141367997|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation was based on primary endpoint. 185 patients were deemed necessary for the lower limit of the observed 2-sided 95% confidence interval for the difference to exceed -5% with 85% power.|Percentage PH better minus GV better|0.0||||1|TWO_SIDED|95.0|-3.8|3.8||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)||Difference in percentage ProHance better minus percentage Gadovist/Gadavist better (%)|||3.8|-3.8|1.0
70933427|NCT01613417|141367997|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation was based on primary endpoint. 185 patients were deemed necessary for the lower limit of the observed 2-sided 95% confidence interval for the difference to exceed -5% with 85% power.|Percentage PH better minus GV better|0.5||||1|TWO_SIDED|95.0|-0.5|1.5||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)||Difference in percentage ProHance better minus percentage Gadovist/Gadavist better (%)|||1.5|-0.5|1.0
71055528|NCT02152605|141615079|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.122|||<|0.001|TWO_SIDED|95.0|0.071|0.172|||Mixed Models Analysis|||||0.172|0.071|<0.001
71055529|NCT02152605|141615080|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.7|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4|||Mixed Models Analysis|||||-0.4|-1.1|<0.001
71055530|NCT03151408|141615081|SUPERIORITY|||||||0.8275||||||P-value stratified by cytogenetic risk factor and ECOG performance status|Log Rank|||||||0.8275
71055531|NCT03151408|141615082|OTHER|||||||0.1244|||||||Cochran-Mantel-Haenszel|||||||0.1244
71055532|NCT03151408|141615083|OTHER|||||||0.143|||||||Cochran-Mantel-Haenszel|||||||0.1430
71055533|NCT03151408|141615084|SUPERIORITY|||||||0.9977|||||||Cochran-Mantel-Haenszel|||||||0.9977
71055534|NCT03151408|141615085|OTHER|||||||0.9959|||||||Cochran-Mantel-Haenszel|||||||0.9959
71055535|NCT03151408|141615086|OTHER|||||||0.3502|||||||Cochran-Mantel-Haenszel|||||||0.3502
71055536|NCT03151408|141615087|OTHER|||||||0.0502|||||||Log Rank|||||||0.0502
71055537|NCT03151408|141615089|OTHER|||||||0.4656|||||||Log Rank|||||||0.4656
71055538|NCT03151408|141615090|OTHER|||||||0.7063|||||||Log Rank|||||||0.7063
71055539|NCT03151408|141615091|OTHER|||||||0.0592|||||||Log Rank|||||||0.0592
71055540|NCT03151408|141615092|OTHER|||||||0.3835|||||||Log Rank|||||||0.3835
71055541|NCT03151408|141615093|OTHER|||||||0.7099|||||||Cochran-Mantel-Haenszel|||||||0.7099
71055542|NCT01235195|141615120|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of adjusted means|104.86|||||TWO_SIDED|90.0|100.12|109.83|||||Reference treatment=Sertraline hydrochloride 50 mg hard gelatin capsule. Test treatment=sertraline hydrochloride 50 mg film-coated tablet.|Natural log-transformed AUC (0-72) analyzed using a mixed effect model with sequence, period, treatment as fixed effects; subject within sequence as a random effect. Estimates of adjusted mean differences (Test minus Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model. Adjusted mean differences and 90% CIs for differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test divided by Reference) and 90% CIs for the ratios.||109.83|100.12|
71055543|NCT01235195|141615121|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of adjusted means|105.34|||||TWO_SIDED|90.0|98.46|112.69|||||Reference treatment=Sertraline hydrochloride 50 mg hard gelatin capsule. Test treatment=sertraline hydrochloride 50 mg film-coated tablet.|Natural log-transformed Cmax analyzed using a mixed effect model with sequence, period, treatment as fixed effects; subject within sequence as a random effect. Estimates of adjusted mean differences (Test minus Reference) and corresponding 90% CIs were obtained from the model. Adjusted mean differences and 90% CIs for differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test divided by Reference) and 90% CIs for the ratios.||112.69|98.46|
71055544|NCT01235195|141615123|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of adjusted means|106.1|||||TWO_SIDED|90.0|100.16|112.39|||||Reference treatment=Sertraline hydrochloride 50 mg hard gelatin capsule. Test treatment=sertraline hydrochloride 50 mg film-coated tablet.|Natural log-transformed AUC (0-∞) analyzed using a mixed effect model with sequence, period, treatment as fixed effects; subject within sequence as a random effect. Estimates of adjusted mean differences (Test minus Reference) and corresponding 90% CIs were obtained from the model. Adjusted mean differences and 90% CIs for differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test divided by Reference) and 90% CIs for the ratios.||112.39|100.16|
71055545|NCT01473524|141615126|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) General Association test stratified by randomization strata factor.||H0: The response rates are equal between placebo and 10 mg OCA. H1: The response rates are different between placebo and 10 mg OCA.||||<0.0001
71055546|NCT01473524|141615128|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) General Association test stratified by randomization strata factor.||H0: The response rates are equal between placebo and 10 mg OCA. H1: The response rates are different between placebo and 10 mg OCA.||||<0.0001
71055547|NCT01473524|141615129|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) General Association test stratified by randomization strata factor.||H0: The response rates are equal between placebo and 5-10 mg OCA. H1: The response rates are different between placebo and 5-10 mg OCA.||||<0.0001
71055548|NCT01473524|141615130|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) General Association test stratified by randomization strata factor.||H0: The response rates are equal between placebo and 5-10 mg OCA. H1: The response rates are different between placebo and 5-10 mg OCA.||||<0.0001
71055549|NCT01473524|141615131|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
71055550|NCT01473524|141615131|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
71055551|NCT01473524|141615132|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004|||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||0.0004
71055552|NCT01473524|141615132|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
71055553|NCT01473524|141615133|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
70933428|NCT01613417|141367998|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
70933429|NCT01613417|141367998|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
70933430|NCT01613417|141367998|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
70933431|NCT01613417|141367999|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
70933432|NCT01613417|141367999|SUPERIORITY_OR_OTHER|||||||0.6875|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||0.6875
70933433|NCT01613417|141367999|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
70933434|NCT01613417|141368000|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
70933435|NCT01613417|141368000|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
70933436|NCT01613417|141368000|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
70933437|NCT01613417|141368001|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
70933438|NCT01613417|141368001|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
70933439|NCT01613417|141368001|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
70933440|NCT01613417|141368002|SUPERIORITY_OR_OTHER|||||||0.2758|TWO_SIDED||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect||||||0.2758
70933441|NCT01613417|141368002|SUPERIORITY_OR_OTHER|||||||0.0676|TWO_SIDED||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect||||||0.0676
70933442|NCT01613417|141368002|SUPERIORITY_OR_OTHER|||||||0.5267|TWO_SIDED||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect||||||0.5267
70933443|NCT01613417|141368003|SUPERIORITY_OR_OTHER|||||||0.6201|TWO_SIDED||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||0.6201
70933444|NCT01613417|141368003|SUPERIORITY_OR_OTHER|||||||0.4514|TWO_SIDED||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||0.4514
70933445|NCT01613417|141368003|SUPERIORITY_OR_OTHER|||||||0.7722|TWO_SIDED||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||0.7722
70933446|NCT01613417|141368004|SUPERIORITY_OR_OTHER|||||||0.3173|TWO_SIDED||||||McNemar|||||||0.3173
70933447|NCT01613417|141368004|SUPERIORITY_OR_OTHER|||||||0.5637|TWO_SIDED||||||McNemar|||||||0.5637
70933448|NCT01613417|141368004|SUPERIORITY_OR_OTHER|||||||0.0455|TWO_SIDED||||||McNemar|||||||0.0455
70933449|NCT01613417|141368005|SUPERIORITY_OR_OTHER|||||||0.6949|TWO_SIDED||||||McNemar|||McNemar test of difference (ProHance minus Gadovist/Gadavist) in accuracy for tumor characterization||||0.6949
70933450|NCT01613417|141368005|SUPERIORITY_OR_OTHER|||||||0.1317|TWO_SIDED||||||McNemar|||McNemar test of difference (ProHance minus Gadovist/Gadavist) in accuracy for tumor characterization||||0.1317
71022328|NCT04288115|141552568|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical difference.|Difference in Group Means|0.8||||0.8793|TWO_SIDED|95.0|-9.4|10.9||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates the real discontinuation mean and the sham discontinuation mean are different. Adjusted for gender and baseline HSSs.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline hypothyroid symptom scores.|Analysis of 6-week outcome||10.9|-9.4|0.8793
71022329|NCT04288115|141552568|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|-2.3||||0.686|TWO_SIDED|95.0|-14.0|9.3||Group differences.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline HSS.|Differences are reported as sham discontinuation mean minus real discontinuation mean. These differences have been adjusted for gender and baseline hypothyroid symptom scores.|Analysis of 6-month outcome||9.3|-14.0|0.6860
71022330|NCT04288115|141552569|NON_INFERIORITY|A one-sided α-level of 0.05 will be used to determine the statistical significance of the non-inferiority test.|Difference in Group Means|5.2||||0.0036|TWO_SIDED|90.0|-6.2|16.6||Group differences.|Welch's two-sample t-test|A one-sided p-value \< 0.05 indicates the discontinuation mean falls within the non-inferiority limit.|Differences reported as the sham discontinuation mean minus the real discontinuation mean.|A one-sided t-test will be used to determine whether the mean Tiredness score for the real discontinuation group is no more than 14 points worse than the score of the sham discontinuation group at 6 months.||16.6|-6.2|0.0036
71022331|NCT04288115|141552569|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|2.3||||0.7104|TWO_SIDED|95.0|-10.1|14.7||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline score.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These mean differences have been adjusted for gender and baseline tiredness score.|Analysis of 6-week outcome||14.7|-10.1|0.7104
71022332|NCT04288115|141552569|OTHER|A two-sided α-level of 0.05 will be used to determine statistical significance.|Difference in Group Means|5.4||||0.3381|TWO_SIDED|95.0|-5.9|16.7||Group differences.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline score.|Differences reported as sham discontinuation mean minus real discontinuation mean. These differences have been adjusted for gender and baseline tiredness scores.|Analysis of 6-month outcome||16.7|-5.9|0.3381
71055554|NCT01473524|141615133|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
71107291|NCT02415556|141720853|OTHER|"A spatial power variance-covariance structure was used to model within-subject correlated measurements where the number of days from the baseline visit was used as the power of the autoregressive correlation coefficient. Each efficacy and safety outcome variable was modeled separately.~The independent variables included: 4 treatment groups, TIMEG (baseline, on-treatment and post-treatment period), TIMEG \* treatment group.; an average number of treatment days; subjects as random effects."|Mean Difference (Final Values)|6.52||||0.025|TWO_SIDED|95.0|0.81|12.23||Mixed model p-value represents on-treatment difference between between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||12.23|0.81|0.025
71107292|NCT02415556|141720853|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|5.28||||0.051|TWO_SIDED|95.0|-0.03|10.6||Mixed model p-value represents on-treatment difference between between Control - Insulin vs. Control - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||10.60|-0.03|0.051
71107293|NCT02415556|141720854|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|8.31||||0.007|TWO_SIDED|95.0|2.33|14.29||Mixed model p-value represents on-treatment difference between between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||14.29|2.33|0.007
71107294|NCT02415556|141720854|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|2.71||||0.342|TWO_SIDED|95.0|-2.9|8.32||Mixed model p-value represents on-treatment difference between between Control - Insulin vs. Control - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||8.32|-2.90|0.342
71107295|NCT02415556|141720855|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|-0.37||||0.144|TWO_SIDED|95.0|-0.87|0.13||Mixed model p-value represents on-treatment difference between between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||0.13|-0.87|0.144
71117622|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
70933451|NCT01613417|141368005|SUPERIORITY_OR_OTHER|||||||0.0124|TWO_SIDED||||||McNemar|||McNemar test of difference (ProHance minus Gadovist/Gadavist) in accuracy for tumor characterization||||0.0124
70933452|NCT00790699|141368007|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||RM-ANOVA|||The results were evaluated to determine if any statistically significant changes in any of these measures between the first and final visit occurred and if these changes were associated with membership in the treatment or control group.||||>.05
71022333|NCT04288115|141552570|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|-0.02||||0.4684|TWO_SIDED|95.0|-0.076|0.036||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline score.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline EQ-5D Descriptive scores.|Analysis of 6-week EQ-5D Descriptive score outcome.||0.036|-0.076|0.4684
71022334|NCT04288115|141552570|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|0.003||||0.9585|TWO_SIDED|95.0|-0.102|0.107||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline score.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline EQ-5D Descriptive scores.|Analysis of 6-month EQ-5D Descriptive score outcome.||0.107|-0.102|0.9585
71022335|NCT04288115|141552570|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|7.0||||0.0643|TWO_SIDED|95.0|-0.4|14.4||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline score.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline EQ-5D VAS scores.|Analysis of 6-week EQ-5D VAS score outcome.||14.4|-0.4|0.0643
71022336|NCT04288115|141552570|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|-6.2||||0.1742|TWO_SIDED|95.0|-15.3|2.9||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline scores.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline EQ-5D VAS scores.|Analysis of 6-month EQ-5D VAS score outcome.||2.9|-15.3|0.1742
71022337|NCT04288115|141552571|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|-12.0||||0.1695|TWO_SIDED|95.0|-29.3|5.3||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline value.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline total cholesterol value.|Analysis of 6-month total cholesterol outcome.||5.3|-29.3|0.1695
71022338|NCT04288115|141552571|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|-6.8||||0.3805|TWO_SIDED|95.0|-22.2|8.6||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline value.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline LDL values.|Analysis of 6-month LDL outcome.||8.6|-22.2|0.3805
71022339|NCT04288115|141552571|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|1.7||||0.5724|TWO_SIDED|95.0|-4.44|7.9||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline value.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline HDL values.|Analysis of 6-month HDL outcome.||7.9|-4.44|0.5724
71022340|NCT04288115|141552571|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|-17.8||||0.3939|TWO_SIDED|95.0|-59.4|23.9||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline value.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline triglyceride values.|Analysis of 6-month triglyceride outcome.||23.9|-59.4|0.3939
71022341|NCT00529568|141552643|SUPERIORITY_OR_OTHER||Percentage difference in SVR|6.0||||0.0202|TWO_SIDED|95.0|1.2|10.9||Stratified Cochran-Mantel-Haenszel (CMH) chi-square test adjusted for the randomization strata|Cochran-Mantel-Haenszel||The estimated value reflects the percentage of participants with SVR in the eltrombopag group minus the percentage of participants with SVR in the placebo group. Adjusted for the actual strata: HCV genotype, baseline platelet count, and HCV RNA.|||10.9|1.2|0.0202
71022342|NCT00931385|141552666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.113|0.183|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.183|0.113|<0.0001
71022343|NCT00931385|141552666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.113|0.183|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.183|0.113|<0.0001
71022344|NCT00931385|141552666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.106|0.177|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.177|0.106|<0.0001
71055555|NCT01473524|141615134|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
71022345|NCT00931385|141552667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.109|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.073|0.146|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.146|0.073|<0.0001
71022346|NCT00931385|141552667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.091|0.164|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.164|0.091|<0.0001
70933453|NCT00734578|141368079|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-4.5||||0.002||95.0|-7.5|-1.4||Both SPD503 groups were compared with placebo using Dunnett's adjustment. Each treatment comparison was evaluated at the 0.05 significance level (Dunnett's adjusted).|ANCOVA|||The null hypothesis stated that there was no difference between SPD503 AM or placebo and that there was no difference between SPD503 PM or placebo. 90% power was needed to detect an effect size of at least 0.4 between either SPD503 group and placebo.||-1.4|-7.5|0.002
71107296|NCT02415556|141720855|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|-0.64||||0.008|TWO_SIDED|95.0|-1.11|-0.16||Mixed model p-value represents on-treatment difference between between Control - Insulin vs. Control - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||-0.16|-1.11|0.008
71107297|NCT02415556|141720856|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|0.35||||0.149|TWO_SIDED|95.0|-0.13|0.83||Mixed model p-value represents on-treatment difference between between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||0.83|-0.13|0.149
71117623|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
70941655|NCT04748445|141383934|OTHER||Slope|-0.2064|STANDARD_ERROR_OF_MEAN|8.474||0.0163|TWO_SIDED|90.0|-0.3468|-0.06599|||Mixed Models Analysis|||MM\_MFCC mean 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.06599|-0.3468|0.0163
71022347|NCT00931385|141552667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.135|0.209|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.209|0.135|<0.0001
71022348|NCT00931385|141552668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.094|0.163|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.163|0.094|<0.0001
71022349|NCT00931385|141552668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.103|0.172|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.172|0.103|<0.0001
71022350|NCT00931385|141552668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.122|0.191|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.191|0.122|<0.0001
71022351|NCT00931385|141552669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.126|0.201|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.201|0.126|<0.0001
71022352|NCT00931385|141552669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.127|0.202|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.202|0.127|<0.0001
71022353|NCT00931385|141552669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.16|0.236|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.236|0.160|<0.0001
71022354|NCT00931385|141552670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.135|0.214|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.214|0.135|<0.0001
71022355|NCT00931385|141552670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.127|0.206|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.206|0.127|<0.0001
71022356|NCT00931385|141552670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.178|0.257|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.257|0.178|<0.0001
71022357|NCT00931385|141552671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.064|0.147|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.147|0.064|<0.0001
71107298|NCT02415556|141720856|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|0.35||||0.134|TWO_SIDED|95.0|-0.11|0.8||Mixed model p-value represents on-treatment difference between between Control - Insulin vs. Control - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||0.80|-0.11|0.134
71107299|NCT02415556|141720857|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|10.29||||0.03|TWO_SIDED|95.0|1.0|19.58|||Mixed Models Analysis|||||19.58|1.00|0.030
71107300|NCT02415556|141720857|OTHER|See primary aims.|Mean Difference (Final Values)|2.21||||0.607|TWO_SIDED|95.0|-6.22|10.63||See primary aims.|Mixed Models Analysis|||See primary aims.||10.63|-6.22|0.607
71107301|NCT02415556|141720858|OTHER|See primary aims.|Mean Difference (Final Values)|-2.1||||0.576|TWO_SIDED|95.0|-9.5|5.29||See primary aims.|Mixed Models Analysis|||See primary aims.||5.29|-9.50|0.576
71107302|NCT02415556|141720858|OTHER|See primary aims.|Mean Difference (Final Values)|-0.86||||0.802|TWO_SIDED|95.0|-7.58|5.87||See primary aims.|Mixed Models Analysis|||See primary aims.||5.87|-7.58|0.802
70933454|NCT00734578|141368079|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-5.3|||<|0.001||95.0|-8.3|-2.3||Both SPD503 groups were compared with placebo using Dunnett's adjustment. Each treatment comparison was evaluated at the 0.05 significance level (Dunnett's adjusted).|ANCOVA|||The null hypothesis stated that there was no difference between SPD503 AM or placebo and that there was no difference between SPD503 PM or placebo. 90% power was needed to detect an effect size of at least 0.4 between either SPD503 group and placebo.||-2.3|-8.3|<0.001
70933455|NCT00734578|141368080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||0.024
70933456|NCT00734578|141368080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||0.003
71107303|NCT02415556|141720859|EQUIVALENCE|CBF and vasoreactivity maps were analyzed on a voxel-by-voxel basis using Statistical non-Parametric Mapping (SnPM, http://www.sph.umich.edu/ni-stat/SnPM/), voxel-level threshold p \< 0.005.||||||0.03|||||||Voxel-Based Morphometry|||||||0.03
71107304|NCT01621178|141720862|NON_INFERIORITY|Non-Inferiority to Glargine with a 0.4% margin|Mean Difference (Final Values)|-0.05|||<|0.001|TWO_SIDED|95.0|-0.26|0.15|||Mixed Models Analysis|||Week 26||0.15|-0.26|<0.001
71107305|NCT01621178|141720862|NON_INFERIORITY|Non-Inferiority to Glargine with a 0.4% margin|Mean Difference (Final Values)|0.02|||<|0.001|TWO_SIDED|95.0|-0.18|0.22|||Mixed Models Analysis|||Week 26||0.22|-0.18|<0.001
71107306|NCT02465931|141720900|OTHER|||||||0.89|||||||t-test, 1 sided|||||||0.89
71107307|NCT02896257|141720902|SUPERIORITY||Odds Ratio (OR)|3.66|||<|0.001|TWO_SIDED|95.0|2.5|5.38|||Regression, Logistic|Mixed-random effects for provider clustering and adjusting for smoking status. Multiple imputation by chained equations for missing smoking status.||||5.38|2.50|<0.001
71107308|NCT02896257|141720903|SUPERIORITY||Odds Ratio (OR)|0.8||||0.47|TWO_SIDED|95.0|0.44|1.47|||Regression, Logistic|Mixed-random effects for provider clustering and adjusting for smoking status. Multiple imputation by chained equations for missing smoking status.||||1.47|0.44|0.47
70933457|NCT00734578|141368081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||0.013
70933458|NCT00734578|141368081|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||<0.001
70933459|NCT00734578|141368082|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-1.7||||0.019||95.0|-3.2|-0.3||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-0.3|-3.2|0.019
70933460|NCT00734578|141368082|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-2.6|||<|0.001||95.0|-4.0|-1.1||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-1.1|-4.0|<0.001
70933461|NCT00734578|141368083|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-2.4||||0.002||95.0|-4.0|-0.9||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-0.9|-4.0|0.002
70933462|NCT00734578|141368083|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-3.0|||<|0.001||95.0|-4.5|-1.5||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-1.5|-4.5|<0.001
71107309|NCT02896257|141720904|SUPERIORITY||Odds Ratio (OR)|0.63||||0.42|TWO_SIDED|95.0|0.2|1.96|||Regression, Logistic|Mixed-random effects for provider clustering and adjusting for smoking status. Multiple imputation by chained equations for missing smoking status.||||1.96|0.20|0.42
71107310|NCT00492557|141720910|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given virus subtype was demonstrated if the lower bound of the 2-sided, 95% confidence interval (CI), computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC+TIV - TIV alone) was greater than -0.10.|Percent Difference|1.7|||||TWO_SIDED|95.0|-3.1|6.5||||||Influenza virus subtype: A/H1N1. Primary null hypothesis for each of the influenza virus subtypes is: proportion of participants achieving a 4-fold increase in titer when 13vPnC+TIV were administered concomitantly, minus the proportion of participants achieving a 4-fold increase in titer when TIV was administered alone (with placebo) \<= -0.10.||6.5|-3.1|
71107311|NCT00492557|141720910|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given virus subtype was demonstrated if the lower bound of the 2-sided, 95% CI, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC+TIV - TIV alone) was greater than -0.10.|Percent Difference|-4.6|||||TWO_SIDED|95.0|-10.4|1.3||||||Influenza virus subtype: A/H3N2. Primary null hypothesis for each of the influenza virus subtypes is: proportion of participants achieving a 4-fold increase in titer when 13vPnC+TIV were administered concomitantly, minus the proportion of participants achieving a 4-fold increase in titer when TIV was administered alone (with placebo) \<= -0.10.||1.3|-10.4|
71107312|NCT00492557|141720910|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given virus subtype was demonstrated if the lower bound of the 2-sided, 95% CI, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC+TIV - TIV alone) was greater than -0.10.|Percent Difference|-1.8|||||TWO_SIDED|95.0|-7.8|4.1||||||Influenza virus subtype: B. Primary null hypothesis for each of the influenza virus subtypes is: proportion of participants achieving a 4-fold increase in titer when 13vPnC+TIV were administered concomitantly, minus the proportion of participants achieving a 4-fold increase in titer when TIV was administered alone (with placebo) \<= -0.10.||4.1|-7.8|
71107313|NCT00492557|141720911|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.79|||||TWO_SIDED|95.0|0.6|1.04|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 1. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.04|0.60|
71107314|NCT00492557|141720911|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.94|||||TWO_SIDED|95.0|0.78|1.13|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 3. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.13|0.78|
71107315|NCT00492557|141720911|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.66|||||TWO_SIDED|95.0|0.51|0.87|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 4. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.87|0.51|
71107316|NCT00492557|141720911|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.69|||||TWO_SIDED|95.0|0.55|0.86|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 5. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.86|0.55|
71107317|NCT00492557|141720911|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.76|||||TWO_SIDED|95.0|0.61|0.94|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 6A. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.94|0.61|
70933463|NCT00734578|141368084|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||<0.001
71107318|NCT00492557|141720911|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.97|||||TWO_SIDED|95.0|0.75|1.25|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 6B. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.25|0.75|
71107319|NCT00492557|141720911|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.84|||||TWO_SIDED|95.0|0.67|1.07|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 7F. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.07|0.67|
71107320|NCT00492557|141720911|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.8|||||TWO_SIDED|95.0|0.63|1.02|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 9V. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.02|0.63|
70933464|NCT00734578|141368084|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||<0.001
70933465|NCT00734578|141368085|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-2.4||||0.001||95.0|-3.9|-0.9||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-0.9|-3.9|0.001
70933466|NCT00734578|141368085|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-2.2||||0.003||95.0|-3.6|-0.7||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-0.7|-3.6|0.003
71107321|NCT00492557|141720911|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.72|||||TWO_SIDED|95.0|0.53|0.97|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 14. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.97|0.53|
71107322|NCT00492557|141720911|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.8|||||TWO_SIDED|95.0|0.64|1.01|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 18C. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.01|0.64|
71107323|NCT00492557|141720911|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.7|||||TWO_SIDED|95.0|0.56|0.87|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 19A. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.87|0.56|
71107324|NCT00492557|141720911|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.65|||||TWO_SIDED|95.0|0.49|0.85|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 19F. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.85|0.49|
71107325|NCT00492557|141720911|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.95|||||TWO_SIDED|95.0|0.71|1.27|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 23F. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.27|0.71|
71107326|NCT00492557|141720914|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.68|1.24|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 1. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.24|0.68|
71107327|NCT00492557|141720914|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.69|1.2|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 3. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.20|0.69|
71107328|NCT00492557|141720914|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.47|0.95|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 4. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.95|0.47|
71107329|NCT00492557|141720914|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.77|1.6|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 5. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.60|0.77|
71107330|NCT00492557|141720914|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.54|1.08|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 6A. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.08|0.54|
70933467|NCT00734578|141368086|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-5.1|||<|0.001||95.0|-8.0|-2.2||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-2.2|-8.0|<0.001
70933468|NCT00734578|141368086|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-4.7||||0.002||95.0|-7.6|-1.7||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-1.7|-7.6|0.002
70933469|NCT00734578|141368087|SUPERIORITY_OR_OTHER_LEGACY|||||||0.971||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||0.971
71022358|NCT00931385|141552671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.072|0.155|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.155|0.072|<0.0001
71022359|NCT00931385|141552671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.092|0.175|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.175|0.092|<0.0001
71022360|NCT00931385|141552672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.167|0.284|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.284|0.167|<0.0001
71022361|NCT00931385|141552672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.229|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.17|0.287|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.287|0.170|<0.0001
71022362|NCT00931385|141552672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.144|0.262|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.262|0.144|<0.0001
71022363|NCT00931385|141552673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.087|0.207|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.207|0.087|<0.0001
71022364|NCT00931385|141552673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.112|0.231|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.231|0.112|<0.0001
71022365|NCT00931385|141552673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.191|0.311|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.311|0.191|<0.0001
71022366|NCT00931385|141552674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.132|0.241|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.241|0.132|<0.0001
71022367|NCT00931385|141552674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.145|0.254|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.254|0.145|<0.0001
71022368|NCT00931385|141552674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.227|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.172|0.282|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.282|0.172|<0.0001
71022369|NCT00931385|141552675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.261|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.191|0.33|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.330|0.191|<0.0001
71022370|NCT00931385|141552675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.252|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.183|0.322|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.322|0.183|<0.0001
71022371|NCT00931385|141552675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.302|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.232|0.372|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.372|0.232|<0.0001
71022372|NCT00931385|141552676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.087|0.221|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.221|0.087|<0.0001
71022373|NCT00931385|141552676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.086|0.221|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.221|0.086|<0.0001
71022374|NCT00931385|141552676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.115|0.25|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.250|0.115|<0.0001
71022375|NCT04444752|141552702|SUPERIORITY|Pairwise comparisons for each CBP-201 group vs placebo were performed and a serial gate-keeping procedure was used for multiplicity adjustment. Each CBP-201 group was compared to placebo group in order from highest dose (300 mg Q2W) to the lowest dose frequency (300 mg Q4W), until statistical signficance at p=0.05 level was not achieved.|Mean Difference (Final Values)|23.36|STANDARD_ERROR_OF_MEAN|6.794||0.0007|TWO_SIDED|||||Adjusted for multiplicity using a serial gatekeeping procedure at the 5% in descending order: 1. 300 mg dose Q2W 2. 150 mg dose Q2W 3. 300 mg dose Q4W vs placebo|ANCOVA|The data were analyzed using an ANCOVA model adjusted for treatment, baseline vIGA (moderate, severe), and baseline EASI.||"The primary efficacy analysis includes comparison of percentage reduction in EASI from baseline to Week 16 for CBP-201 300 mg Q2W regimen vs placebo.~The sample size of the study was determined based on power calculations for the primary endpoint in patients receiving CBP-201 300 mg Q2W.~Null hypothesis: CBP-201 300 Q2W is not superior to placebo in terms of percent reduction in EASI Score from Baseline to Week 16."||||0.0007
71055556|NCT01473524|141615134|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
70933470|NCT00734578|141368087|SUPERIORITY_OR_OTHER_LEGACY|||||||0.502||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||0.502
70933471|NCT04652726|141368105|SUPERIORITY||LS Mean|-28.54|||<|0.0001|TWO_SIDED|95.0|-35.81|-21.27|||ANCOVA|||||-21.27|-35.81|<.0001
70933472|NCT04652726|141368106|SUPERIORITY||LS Mean|-29.3|||<|0.0001|TWO_SIDED|95.0|-36.24|-22.36|||MMRM|||||-22.36|-36.24|<.0001
71022376|NCT04444752|141552702|SUPERIORITY|Pairwise comparisons for each CBP-201 group vs placebo were performed and a serial gatekeeping procedure was used for multiplicity adjustment. Each CBP-201 group was compared with the placebo group in order from the highest dose (300 mg Q2W) to the lowest dose frequency (300 mg Q4W), until statistical significance at 0.05 level was not achieved.|Mean Difference (Final Values)|17.89|STANDARD_ERROR_OF_MEAN|6.537||0.0067|TWO_SIDED|||||Adjusted for multiplicity using a serial gatekeeping procedure at the 5% in descending order: 1. 300 mg dose Q2W 2. 150 mg Q2W 3. 300 mg Q4W vs placebo.|ANCOVA|The data were analyzed using an ANCOVA model with terms for treatment, baseline vIGA (moderate, severe), and baseline EASI.||"The sample size of the study was determined based on power calculations for the primary endpoint in patients receiving CBP-201 300 mg Q2W.~Null hypothesis: CBP-201 150 Q2W is not superior to placebo in terms of percent reduction in EASI Score from Baseline to Week 16."||||0.0067
71022377|NCT04444752|141552702|SUPERIORITY|Pairwise comparisons for each CBP-201 group vs placebo were performed and a serial gatekeeping procedure was used for multiplicity adjustment. Each CBP-201 group was compared with placebo in order from highest dose (300 mg Q2W) to the lowest dose frequency (300 mg Q4W), until statistical significance at the 0.05 level was not achieved.|Mean Difference (Final Values)|23.83|STANDARD_ERROR_OF_MEAN|6.575||0.0004|TWO_SIDED|||||Adjusted for mulitplicity using a serial gatekeeping procedure at the 5% in descending order: 1. 300 mg dose Q2W 2. 150 mg Q2W 3. 300 mg Q4W vs placebo.|ANCOVA|The data were anlayzed using an ANCOVA model with terms for treatment, baseline vIGA (moderate, severe), and baseline EASI||"The efficacy analysis includes comparing percentage reduction in EASI from baseline to Week 16 for CBP-201 300 mg Q4W regimen vs placebo.~The sample size of the study was determined based on power calculations for the primary endpoint in patients receiving CBP-201 300 mg Q2W.~Null hypothesis: CBP-201 300 Q4W is not superior to placebo in terms of percent reduction in EASI Score from Baseline to Week 16."||||0.0004
71022378|NCT04444752|141552703|SUPERIORITY|The secondary efficacy analysis includes comparison of the number of patients achieving a vIGA score of 0/1 (clear/almost clear) at Week 16 for each CBP-201 300 mg Q2W vs placebo.|Difference in vIGA Response Rate|28.1||||0.0089|TWO_SIDED|||||There were no adjustments for multiple comparisons. For IGA response, counts, percentage, and 95% CIs obtained using the Clopper-Pearson method and were presented for pairwise comparisons for each CBP-201 group vs. placebo.|Chi-squared|||Null hypothesis: CBP-201 300 Q2W is not superior to placebo in terms of the number of patients achieving a vIGA score of 0/1 (clear/almost clear) at Week 16.||||0.0089
71022379|NCT02270983|141552704|SUPERIORITY||Least squares mean difference|1.325|STANDARD_ERROR_OF_MEAN|0.45||0.0035|TWO_SIDED|95.0|0.439|2.211|||ANCOVA|||||2.211|0.439|0.0035
71022380|NCT02270983|141552704|SUPERIORITY||Least squares mean difference|1.908|STANDARD_ERROR_OF_MEAN|0.451|<|0.0001|TWO_SIDED|95.0|1.021|2.796|||ANCOVA|||||2.796|1.021|<0.0001
71022381|NCT02270983|141552705|SUPERIORITY||Cox Proportional Hazard|1.28||||0.1429|TWO_SIDED|95.0|0.92|1.77|||Log Rank|||||1.77|0.92|0.1429
71022382|NCT02270983|141552705|SUPERIORITY||Cox Proportional Hazard|1.43||||0.0287|TWO_SIDED|95.0|1.04|1.97|||Log Rank|||||1.97|1.04|0.0287
71022383|NCT02270983|141552706|SUPERIORITY||Odds Ratio (OR)|1.37||||0.3332|TWO_SIDED|95.0|0.73|2.58|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel tests comparing specified treatment groups, controlling for geographic region.||||2.58|0.73|0.3332
71022384|NCT02270983|141552706|SUPERIORITY||Odds Ratio (OR)|1.92||||0.0506|TWO_SIDED|95.0|1.0|3.68|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel tests comparing specified treatment groups, controlling for geographic region.||||3.68|1.00|0.0506
71022385|NCT02270983|141552707|SUPERIORITY||Least squares mean difference|0.751|STANDARD_ERROR_OF_MEAN|0.217||0.0007|TWO_SIDED|95.0|0.324|1.178|||ANCOVA|||||1.178|0.324|0.0007
71022386|NCT02270983|141552707|SUPERIORITY||Least squares mean difference|0.987|STANDARD_ERROR_OF_MEAN|0.217|<|0.0001|TWO_SIDED|95.0|0.558|1.416|||ANCOVA|||||1.416|0.558|<0.0001
71055557|NCT01473524|141615135|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||0.0003
71022387|NCT02270983|141552708|SUPERIORITY||Least squares mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.145||0.0017|TWO_SIDED|95.0|-0.746|-0.174|||ANCOVA|||||-0.174|-0.746|0.0017
71055558|NCT01473524|141615135|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor||||||<0.0001
71055559|NCT01473524|141615136|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
71055560|NCT01473524|141615136|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
71055561|NCT01544179|141615139|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.273|TWO_SIDED|95.0|0.65|1.13|||Cox Proportional Hazards|||||1.13|0.65|0.273
71055562|NCT01544179|141615142|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.62||||0.029|TWO_SIDED|95.0|1.05|2.52|||Cox Proportional Hazards|||||2.52|1.05|0.029
70933473|NCT04652726|141368107|SUPERIORITY||LS Mean|-49.99|||<|0.0001|TWO_SIDED|95.0|-63.18|-36.81|||ANCOVA|||||-36.81|-63.18|<.0001
70933474|NCT04652726|141368108|SUPERIORITY||LS Mean|-25.7|||<|0.0001|TWO_SIDED|95.0|-31.68|-19.73|||ANCOVA|||||-19.73|-31.68|<.0001
70933475|NCT04652726|141368109|SUPERIORITY||LS Mean|-6.18||||0.1419|TWO_SIDED|95.0|-17.48|5.12|||ANCOVA|||||5.12|-17.48|0.1419
70933476|NCT04652726|141368110|SUPERIORITY||LS Mean|-26.8|||<|0.0001|TWO_SIDED|95.0|-33.63|-19.97|||ANCOVA|||||-19.97|-33.63|<.0001
70933477|NCT04652726|141368111|SUPERIORITY||LS Mean|-19.2|||<|0.0001|TWO_SIDED|95.0|-24.65|-13.75|||ANCOVA|||||-13.75|-24.65|<.0001
71022388|NCT02270983|141552708|SUPERIORITY||Least squares mean difference|-0.669|STANDARD_ERROR_OF_MEAN|0.146|<|0.0001|TWO_SIDED|95.0|-0.957|-0.382|||ANCOVA|||||-0.382|-0.957|<0.0001
71055563|NCT01544179|141615143|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.92||||0.76|TWO_SIDED|95.0|0.55|1.55|||Regression, Logistic|||||1.55|0.55|0.760
70933478|NCT03274076|141368148|SUPERIORITY||Rate ratio|1.25|||||TWO_SIDED|90.0|0.19|8.33|||||Tofacitinib represents the numerator, and placebo represents the denominator.|H0: Rate of grade 3 (severe) or higher adverse events that occur throughout week 48 in Placebo = Rate of grade 3 (severe) or higher adverse events that occur throughout week 48 in Tofacitinib.||8.33|0.19|
71022389|NCT02270983|141552709|SUPERIORITY||Least squares mean difference|0.033|STANDARD_ERROR_OF_MEAN|0.205||0.872|TWO_SIDED|95.0|-0.371|0.437|||ANCOVA|||||0.437|-0.371|0.8720
71022390|NCT02270983|141552709|SUPERIORITY||Least squares mean difference|-0.607|STANDARD_ERROR_OF_MEAN|0.205||0.0034|TWO_SIDED|95.0|-1.011|-0.203|||ANCOVA|||||-0.203|-1.011|0.0034
71022391|NCT01706198|141552768|OTHER||Adjusted Odds Ratio|2.0|||<|0.001|TWO_SIDED|95.0|1.7|2.34||The analysis method was logistic regression adjusted for randomized treatment, asthma maintenance therapy (AMT) at Baseline per randomization stratification, Baseline ACT total score, Baseline ACT total score squared, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care has been presented.|||2.34|1.70|<0.001
71022392|NCT01706198|141552769|OTHER||Adjusted Odds Ratio|1.92|||<|0.001|TWO_SIDED|95.0|1.67|2.2||Logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, Baseline ACT total score squared, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care for Week 12 has been presented.|||2.20|1.67|<0.001
71022393|NCT01706198|141552769|OTHER||Adjusted Odds Ratio|1.66|||<|0.001|TWO_SIDED|95.0|1.45|1.91||Logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, Baseline ACT total score squared, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care for Week 40 has been presented.|||1.91|1.45|<0.001
71022394|NCT01706198|141552769|OTHER||Adjusted Odds Ratio|1.76|||<|0.001|TWO_SIDED|95.0|1.54|2.02||Logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, Baseline ACT total score squared, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care for Week 52 has been presented.|||2.02|1.54|<0.001
71022395|NCT01706198|141552770|OTHER||Adjusted Odds Ratio|2.09|||<|0.001|TWO_SIDED|95.0|1.82|2.4||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 12 has been presented.|||2.40|1.82|<0.001
71055564|NCT01544179|141615144|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.39||||0.308|TWO_SIDED|95.0|0.74|2.62|||Regression, Logistic|||||2.62|0.74|0.308
70933479|NCT03274076|141368149|SUPERIORITY||Rate ratio|0.65|||||TWO_SIDED|90.0|0.25|1.71|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of grade 2 (moderate) or higher adverse events that occur throughout week 12 in Placebo = Rate of grade 2 (moderate) or higher adverse events that occur throughout week 12 in Tofacitinib||1.71|0.25|
70933480|NCT03274076|141368149|SUPERIORITY||Rate ratio|0.53|||||TWO_SIDED|90.0|0.26|1.07|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of grade 2 (moderate) or higher adverse events that occur throughout week 24 in Placebo = Rate of grade 2 (moderate) or higher adverse events that occur throughout week 24 in Tofacitinib||1.07|0.26|
71055565|NCT01544179|141615145|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.92||||0.77|TWO_SIDED|95.0|0.53|1.59|||Regression, Logistic|||||1.59|0.53|0.770
71055566|NCT01544179|141615146|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.507|TWO_SIDED|95.0|0.68|1.21|||Cox Proportional Hazards|||||1.21|0.68|0.507
71055567|NCT01544179|141615147|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.91||||0.725|TWO_SIDED|95.0|0.54|1.53|||Regression, Logistic|||||1.53|0.54|0.725
71055568|NCT01544179|141615148|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92||||0.575|TWO_SIDED|95.0|0.69|1.23|||Cox Proportional Hazards|||||1.23|0.69|0.575
71055569|NCT01544179|141615149|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01||||0.959|TWO_SIDED|95.0|0.61|1.68|||Regression, Logistic|||||1.68|0.61|0.959
71055570|NCT01544179|141615150|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.89||||0.437|TWO_SIDED|95.0|0.66|1.2|||Cox Proportional Hazards|||||1.20|0.66|0.437
71055571|NCT03857750|141615207|OTHER||Mean Difference (Final Values)|82.0|||<|0.001|TWO_SIDED|95.0|40.0|124.0|||t-test, 2 sided|||Comparing onset time of rocuronium||124|40|<0.001
71055572|NCT03857750|141615207|OTHER||Odds|19.48|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon Mann-Whitney odd||95 % confidence interval is 7.63 to infinity|82||||<0.001
71055573|NCT03857750|141615209|OTHER||Mean Difference (Final Values)|31.0|||<|0.001|TWO_SIDED|95.0|14.0|48.0|||t-test, 2 sided|||Comparing duration of action of rocuronium||48|14|<0.001
71055574|NCT03857750|141615209|OTHER||Odds|6.35||||0.001|TWO_SIDED||||||Wilcoxon Mann-Whitney odd||95% Confidence interval is 2.59 to infinity.|Comparing duration of action of rocuronium||||0.001
71055575|NCT01994291|141615218|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was to be declared if the lower limit of the confidence interval for the mean difference at Week 12 is greater than -3.0 letters.|Difference in LS means|-2.32|STANDARD_ERROR_OF_MEAN|1.52||0.1271|TWO_SIDED|80.0|-4.27|-0.37|||Mixed Models Analysis|||The null hypothesis was that the difference, in the mean change from baseline in BCVA in the PF-04634817 group,and the control group is less than or equal to -3 letters.||-0.37|-4.27|0.1271
71055576|NCT01994291|141615218|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was to be declared if the lower limit of the confidence interval for the mean difference at Week 12 is greater than -3.0 letters.|Difference in LS means|-2.48|STANDARD_ERROR_OF_MEAN|1.36||0.0699|TWO_SIDED|80.0|-4.24|-0.73|||Mixed Models Analysis|||The null hypothesis was that the difference, in the mean change from baseline in BCVA in the PF-04634817 group,and the control group is less than or equal to -3 letters.||-0.73|-4.24|0.0699
71055577|NCT01994291|141615218|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was to be declared if the lower limit of the confidence interval for the mean difference at Week 12 is greater than -3.0 letters.|Difference in LS means|-2.41|STANDARD_ERROR_OF_MEAN|1.17||0.0399|TWO_SIDED|80.0|-3.91|-0.91|||Mixed Models Analysis|||The null hypothesis was that the difference, in the mean change from baseline in BCVA in the PF-04634817 group,and the control group is less than or equal to -3 letters.||-0.91|-3.91|0.0399
71055578|NCT01994291|141615219|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1416||||0.0218|TWO_SIDED|80.0|-0.2483|-0.0467|||Barnard test|||||-0.0467|-0.2483|0.0218
71055579|NCT01994291|141615219|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.0442||||0.4209|TWO_SIDED|80.0|-0.1217|0.0261|||Barnard test.|||baseline in BCVA in the PF-04634817 group,and the control group is less than or equal to -3 letters.||0.0261|-0.1217|0.4209
71055580|NCT01994291|141615219|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.0849||||0.0778|TWO_SIDED|80.0|-0.1516|-0.0168|||Barnard test.|||||-0.0168|-0.1516|0.0778
71055581|NCT01994291|141615220|SUPERIORITY_OR_OTHER||Difference in LS means|114.07|STANDARD_ERROR_OF_MEAN|19.84|<|0.0001|TWO_SIDED|80.0|88.56|139.59|||Mixed Models Analysis|||||139.59|88.56|<0.0001
71055582|NCT01994291|141615220|SUPERIORITY_OR_OTHER||Difference in LS means|65.81|STANDARD_ERROR_OF_MEAN|18.36||0.0004|TWO_SIDED|80.0|42.2|89.43|||Mixed Models Analysis|||||89.43|42.20|0.0004
71055583|NCT01994291|141615220|SUPERIORITY_OR_OTHER||Difference in LS means|87.32|STANDARD_ERROR_OF_MEAN|15.44|<|0.0001|TWO_SIDED|80.0|67.45|107.19|||Mixed Models Analysis|||||107.19|67.45|<0.0001
71055584|NCT01994291|141615221|SUPERIORITY_OR_OTHER||Difference in LS means|7.98|STANDARD_ERROR_OF_MEAN|1.44|<|0.0001|TWO_SIDED|80.0|6.13|9.83|||ANCOVA|||||9.83|6.13|<0.0001
71055585|NCT01994291|141615221|SUPERIORITY_OR_OTHER||Difference in LS means|6.34|STANDARD_ERROR_OF_MEAN|1.28|<|0.0001|TWO_SIDED|80.0|4.7|7.98|||ANCOVA|||||7.98|4.70|<0.0001
71055586|NCT01994291|141615221|SUPERIORITY_OR_OTHER||Difference in LS means|7.07|STANDARD_ERROR_OF_MEAN|1.09|<|0.0001|TWO_SIDED|80.0|5.66|8.48|||ANCOVA|||||8.48|5.66|<0.0001
71055587|NCT01994291|141615222|SUPERIORITY_OR_OTHER||Difference in LS means|0.34|STANDARD_ERROR_OF_MEAN|0.17||0.0423|TWO_SIDED|80.0|0.13|0.55|||ANCOVA|||||0.55|0.13|0.0423
71055588|NCT01994291|141615222|SUPERIORITY_OR_OTHER||Difference in LS means|0.55|STANDARD_ERROR_OF_MEAN|0.15||0.0004|TWO_SIDED|80.0|0.36|0.75|||ANCOVA|||||0.75|0.36|0.0004
71055589|NCT01994291|141615222|SUPERIORITY_OR_OTHER||Difference in LS means|0.46|STANDARD_ERROR_OF_MEAN|0.13||0.0004|TWO_SIDED|80.0|0.3|0.63|||ANCOVA|||||0.63|0.30|0.0004
71055590|NCT00856375|141615237|OTHER|Hazard Ratio and 95% CI from univariate Cox regression model|Hazard Ratio (HR)|0.645|||=|0.07|TWO_SIDED|95.0|0.4|1.041|||Log Rank|||||1.041|0.4|= 0.07
71055591|NCT00856375|141615238|OTHER|Hazard ratio and 95% CI from univariate Cox regression model.|Hazard Ratio (HR)|0.91|||=|0.706|TWO_SIDED|95.0|0.557|1.486|||Log Rank|||||1.486|0.557|= 0.706
71055592|NCT00856375|141615239|OTHER|ORR 95% CI based on Exact (Clopper-Pearson) confidence limits. Odds ratio 95% CI based on asymptotic confidence limits.|Odds Ratio (OR)|2.054|||=|0.676|TWO_SIDED|95.0|0.355|11.9|||Fisher Exact|||||11.9|0.355|= 0.676
71055593|NCT00856375|141615240|SUPERIORITY||||||=|0.018|||||||Log Rank|||||||= 0.018
71055594|NCT02922738|141615253|SUPERIORITY||Cox Proportional Hazard|0.92||||0.54|TWO_SIDED|95.0|0.7|1.21|||Regression, Cox|||||1.21|0.70|0.54
71055595|NCT02922738|141615254|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
70933481|NCT03274076|141368149|SUPERIORITY||Rate ratio|0.85|||||TWO_SIDED|90.0|0.49|1.49|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of grade 2 (moderate) or higher adverse events that occur throughout week 36 in Placebo = Rate of grade 2 (moderate) or higher adverse events that occur throughout week 36 in Tofacitinib||1.49|0.49|
70933482|NCT03274076|141368149|SUPERIORITY||Rate ratio|0.89|||||TWO_SIDED|90.0|0.52|1.52|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of grade 2 (moderate) or higher adverse events that occur throughout week 48 in Placebo = Rate of grade 2 (moderate) or higher adverse events that occur throughout week 48 in Tofacitinib||1.52|0.52|
71055596|NCT03201445|141615266|OTHER||Difference in Percentage|-7.8|||||TWO_SIDED|95.0|-16.3|0.7|||||Difference in percentage and 95% confidence interval (CI) was based on a stratified Mantel-Haenszel test.|||0.7|-16.3|
71055597|NCT03201445|141615268|OTHER||Median Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-2.1|1.8|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||1.8|-2.1|
71055598|NCT03201445|141615270|OTHER||Median Difference (Final Values)|5.7|||||TWO_SIDED|95.0|-13.4|24.7|||||Difference in medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||24.7|-13.4|
71055599|NCT03201445|141615272|OTHER||Median Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.8|4.9|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||4.9|-2.8|
71055600|NCT03201445|141615274|OTHER||Median Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.1|0.3|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||0.3|-0.1|
71055601|NCT03201445|141615276|OTHER||Median Difference (Final Values)|2.0|||||TWO_SIDED|95.0|0.0|4.0|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||4|0|
71055602|NCT03203564|141615307|OTHER||Mean Difference (Final Values)|7.4|||||TWO_SIDED|90.0|0.68|14.12|||||Parameter estimate is done for Placebo-corrected change-from baseline QTcF (ΔΔQTcF) for Modufolin 500 mg/m2 at end of infusion.|"The primary analysis of QTcF was based on a linear mixed-effects model with change-from-baseline QTcF as the dependent variable, time (categorical), treatment, and time-by-treatment interaction as fixed effects, and baseline QTcF as a covariate. The least-squares (LS) mean and 2-sided 90 % CIs have been calculated for the contrast Modufolin® versus placebo at each dose of Modufolin® and each post-dose time point."||14.12|0.68|
71055603|NCT04630158|141615338|SUPERIORITY||Least Square (LS) mean difference|1.6|STANDARD_ERROR_OF_MEAN|5.1||0.93|TWO_SIDED|95.0|-8.5|11.7||Reporting the adjusted p-value derived based on Dunett procedure.|Mixed Models Analysis|mixed-model repeated measures (MMRM) analysis||||11.7|-8.5|0.930
71055604|NCT04630158|141615338|SUPERIORITY||Least Square (LS) mean difference|3.7|STANDARD_ERROR_OF_MEAN|5.11||0.699|TWO_SIDED|95.0|-6.4|13.8||Reporting the adjusted p-value derived based on Dunett procedure.|Mixed Models Analysis|mixed-model repeated measures (MMRM) analysis||||13.8|-6.4|0.699
71107331|NCT00492557|141720914|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.55|1.09|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 6B. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.09|0.55|
71055605|NCT05162014|141615355|OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.76|1.02|||Regression, Cox|Cox proportional hazards regression models based on time-to-first acute pancreatitis used to estimate the hazard ratios.||||1.02|0.76|
71055606|NCT03485365|141615383|OTHER|Bayesian Repeated Measures Model|Median Difference (Net)|-1.18|STANDARD_DEVIATION|0.494|||TWO_SIDED|95.0|-2.15|-0.2|||||Posterior median difference (GSK3858279 - Placebo) and 95% credible interval is presented.|||-0.20|-2.15|
71055607|NCT03485365|141615384|OTHER|Bayesian Repeated Measures Model|Median Difference (Net)|-1.09|STANDARD_DEVIATION|0.612|||TWO_SIDED|95.0|-2.29|0.12|||||Posterior median difference (GSK3858279 - Placebo) and 95% credible interval is presented.|||0.12|-2.29|
71055608|NCT03496610|141615467|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum test performed given non-normal distribution of data by Shapiro Wilks Test. Null hypothesis is that there is no difference in oral morphine equivalent consumption between the two groups in the first 24hrs after surgery. Original sample size calculation based on α=0.05, β=0.8, difference in means=2, and effect size of 1.0.||||0.81
71055609|NCT03496610|141615468|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum test performed with α=0.05. The null hypothesis is that there is no difference between the two groups in pain on postoperative day 7.||||0.40
71055610|NCT03496610|141615469|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum test performed with α=0.05. The null hypothesis is that there is no difference in bloating severity between the two groups.||||0.74
71055611|NCT03496610|141615470|OTHER|||||||0.38|||||||Chi-squared|Degrees of freedom = 1||Compared using the Likelihood ratio test with α=0.05. The null hypothesis was that there is no difference between the groups.||||0.38
71055612|NCT02714426|141615486|OTHER|||||||0.024||||||A priori threshold for statistical significance was set at p \< .05. No adjustment was made for multiple comparisons. The critical effect of interest evaluated here was the Linear Occasion (1-14) x Group (Brain Health vs. Mindfulness) interaction.|Mixed Models Analysis|F(1,33) = 5.57, p = .024, no adjustments.||Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. First-order Autoregressive was best (which specifies homogeneous variance over time but allows one correlation between occasions).||||.024
71107332|NCT00492557|141720914|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.47|1.12|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 7F. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.12|0.47|
71107333|NCT00492557|141720914|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.42|1.03|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 9V. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.03|0.42|
71107334|NCT00492557|141720914|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.65|1.24|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 14. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.24|0.65|
71107335|NCT00492557|141720914|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.59|1.14|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 18C. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.14|0.59|
71107336|NCT00492557|141720914|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.61|1.12|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 19A. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.12|0.61|
71107337|NCT00492557|141720914|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.57|1.16|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 19F. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.16|0.57|
71107338|NCT00492557|141720914|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.54|1.27|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 23F. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.27|0.54|
71107339|NCT04102007|141720917|OTHER|There is no statistical test for this study|Proportion of sPGA 0/1 @ WK 16|57.4|||||TWO_SIDED|95.0|51.1|63.4|||Other|There is no test of hypothesis for this study.|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||63.4|51.1|
71107340|NCT04102007|141720918|OTHER|There is no statistical test for this study|Proportion of sPGA 0 @ WK 16|20.5|||||TWO_SIDED|95.0|15.4|26.0|||Other|There is no test of hypothesis for this study|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||26.0|15.4|
71055613|NCT02714426|141615487|OTHER|||||||0.333||||||A priori threshold for statistical significance was set at p \< .05. No adjustment was made for multiple comparisons. The critical effect of interest evaluated here was the Linear Occasion (1-14) x Group (Brain Health vs. Mindfulness) interaction.|Mixed Models Analysis|F(1,34) = 0.96, p = .333, no adjustments.||Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. Diagonal repeated covariance was best (heterogeneous variance over time, and no residual cross-time covariances).||||0.333
71055614|NCT02714426|141615489|OTHER|||||||0.001||||||A priori threshold for statistical significance was set at p \< .05. No adjustment was made for multiple comparisons. The critical effect of interest evaluated here was the Linear Occasion (1-8) x Group (Brain Health vs. Mindfulness) interaction.|Mixed Models Analysis|F(1,31.069) = 15.046, p = .001, no adjustments.||Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. Diagonal repeated covariance was best (heterogeneous variance over time, and no residual cross-time covariances).||||0.001
71055615|NCT02714426|141615490|OTHER|||||||0.448||||||A priori threshold for statistical significance was set at p \< .05. No adjustment was made for multiple comparisons. The critical effect of interest evaluated here was the Linear Occasion (1-14) x Group (Brain Health vs. Mindfulness) interaction.|Mixed Models Analysis|F(1,34) = 0.589, p = .0.448, no adjustments.||Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. Diagonal repeated covariance was best (heterogeneous variance over time, and no residual cross-time covariances).||||0.448
70933483|NCT03274076|141368150|SUPERIORITY||Rate ratio|3.85|||||TWO_SIDED|90.0|0.68|21.77|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of adverse events of special interest throughout week 36 in Placebo = Rate of adverse events of special interest throughout week 36 in Tofacitinib||21.77|0.68|
70933484|NCT03274076|141368150|SUPERIORITY||Rate ratio|1.87|||||TWO_SIDED|90.0|0.5169|6.7652|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of adverse events of special interest throughout week 48 in Placebo = Rate of adverse events of special interest throughout week 48 in Tofacitinib||6.7652|0.5169|
70933485|NCT03274076|141368151|SUPERIORITY|||||||0.1978|||||||Exact Wilcoxon|||H0: The absolute change in mRSS from week 0 to week 12 in placebo = The absolute change in mRSS from week 0 to week 12 in Tofacitinib.||||0.1978
70933486|NCT03274076|141368151|SUPERIORITY|||||||0.4665|||||||Exact Wilcoxon|||H0: The absolute change in mRSS from week 0 to week 24 in placebo = The absolute change in mRSS from week 0 to week 24 in Tofacitinib.||||0.4665
70933487|NCT03274076|141368151|SUPERIORITY|||||||0.3063|||||||Exact Wilcoxon|||H0: The absolute change in mRSS from week 0 to week 36 in placebo = The absolute change in mRSS from week 0 to week 36 in Tofacitinib.||||0.3063
70933488|NCT03274076|141368151|SUPERIORITY|||||||0.6|||||||Exact Wilcoxon|||H0: The absolute change in mRSS from week 0 to week 48 in placebo = The absolute change in mRSS from week 0 to week 48 in Tofacitinib.||||0.6000
70933489|NCT03274076|141368152|SUPERIORITY|||||||0.4535|||||||Exact Wilcoxon|||H0: The CRISS score at week 12 in placebo = The CRISS score at week 12 in Tofacitinib.||||0.4535
70933490|NCT03274076|141368152|SUPERIORITY|||||||0.8392|||||||Exact Wilcoxon|||H0: The CRISS score at week 24 in placebo = The CRISS score at week 24 in Tofacitinib.||||0.8392
71055616|NCT02714426|141615491|OTHER|||||||0.439||||||A priori threshold for statistical significance was set at p \< .05. No adjustment was made for multiple comparisons. The critical effect of interest evaluated here was the Linear Occasion (1-14) x Group (Brain Health vs. Mindfulness) interaction.|Mixed Models Analysis|F(1,31) = 0.616, p = 0.439, no adjustments.||Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. Diagonal repeated covariance was best (heterogeneous variance over time, and no residual cross-time covariances).||||0.439
71055617|NCT01727726|141615492|OTHER||Mean Difference (Final Values)|-1.48||||0.0078|TWO_SIDED|95.0|-2.56|-0.39|||Cochran-Mantel-Haenszel|Mixed-model repeated measures (MMRM)||||-0.39|-2.56|0.0078
71055618|NCT01727726|141615492|OTHER||Mean Difference (Final Values)|-0.3||||0.6642|TWO_SIDED|95.0|-1.63|1.04|||Cochran-Mantel-Haenszel|Mixed-model repeated measures (MMRM)||||1.04|-1.63|0.6642
71107341|NCT04102007|141720919|OTHER|There is no statistical test for this study|Proportion of DLQI 0 or 1 @ WK 16|40.2|||||TWO_SIDED|95.0|34.2|46.4|||Other|There is no test of hypothesis for this study.|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||46.4|34.2|
71107342|NCT04102007|141720920|OTHER|There is no statistical test for this study|Proportion of PSS 0 @ WK 16|20.9|||||TWO_SIDED|95.0|16.3|26.4|||Other|There is no test of hypothesis for this study|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||26.4|16.3|
70933491|NCT03274076|141368152|SUPERIORITY|||||||0.9212|||||||Exact Wilcoxon|||H0: The CRISS score at week 48 in placebo = The CRISS score at week 48 in Tofacitinib.||||0.9212
70933492|NCT00975585|141368153|NON_INFERIORITY_OR_EQUIVALENCE|Margin = 0.5|Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|97.46|-0.058|0.031|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis is adjusted for lens type, site, lens type by site interaction as fixed effects, subject and eye nested within subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses have non-inferior (less than or equal to) average corneal staining than lotrafilcon B after two weeks of wear.||0.031|-0.058|
70933493|NCT00975585|141368154|NON_INFERIORITY_OR_EQUIVALENCE|Margin = 0.25|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.005|||TWO_SIDED|97.46|-0.021|-0.01|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by site interaction as fixed effects, subject and eye nested within subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses are non-inferior (less than or equal to)in visual acuity to lotrafilcon B contact lenses after two weeks of wear.||-0.010|-0.021|
70933494|NCT00975585|141368155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.402|STANDARD_ERROR_OF_MEAN|0.127|||TWO_SIDED|97.46|0.117|0.402|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by site interaction as fixed effects, subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses have a higher rating of overall comfort than lotrafilcon B after two weeks of wear.||0.402|0.117|
70933495|NCT00975585|141368156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|97.46|-0.218|0.098|||Mixed Models Analysis||The mean difference is lotrafilcon B at 2 weeks minus lotrafilcon B at 4 weeks. Analysis adjusted for duration of wear, stie, duration of wear by site interaction as fixed effects, subject as random effects.|The alternative hypothesis is that lotrafilcon B contact lenses have a lower rating of overall comfort after 4 weeks of wear compared to after 2 weeks of wear.||0.098|-0.218|
70933496|NCT00975585|141368157|NON_INFERIORITY_OR_EQUIVALENCE|Margin = 0.5|Mean Difference (Final Values)|-0.123|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|98.2|-0.123|-0.051|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by site interaction as fixed effects, subject and eye nested within subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses are non-inferior in limbal redness 5 to lotrafilcon B contact lenses after two weeks of wear.||-0.051|-0.123|
70941656|NCT04748445|141383934|OTHER||Slope|-1.265|STANDARD_ERROR_OF_MEAN|9.67||0.1932|TWO_SIDED|90.0|-2.867|3.375|||Mixed Models Analysis|||MM\_MFCC mean 05 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and dispersion value it was 10\^-2. For lower limit and estimated value it was 10\^-1).||3.375|-2.867|0.1932
71107343|NCT04102007|141720921|OTHER|There is no statistical test for this study|Proportion of sPGA 0/1 @ WK 52|62.3|||||TWO_SIDED|95.0|56.0|68.1|||Other|There is no test of hypothesis for this study|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||68.1|56.0|
71107344|NCT04102007|141720922|OTHER|There is no statistical test for this study|Proportion of sPGA 0 @ WK 52|27.1|||||TWO_SIDED|95.0|21.9|33.0|||Other|There is no test of hypothesis for this study|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||33.0|21.9|
71107345|NCT04102007|141720923|OTHER|There is no statistical test for this study|Proportion of DLQI 0 or 1 @ WK 52|47.2|||||TWO_SIDED|95.0|41.0|53.4|||Other|There is no test of hypothesis for this study.|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||53.4|41.0|
71107346|NCT04102007|141720924|OTHER|There is no statistical test for this study|Proportion of PSS 0 @ WK 52|27.5|||||TWO_SIDED|95.0|22.3|33.4|||Other|There is no test of hypothesis for this study|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||33.4|22.3|
71107347|NCT00565409|141720999|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.36|||<|0.0001|TWO_SIDED|95.0|3.2|9.0||P-value from Cochran-Mantel-Haenszel(CMH) test of general association, testing treatment effect on response. P-value and Odds Ratio (OR) stratified by geographic region.|Cochran-Mantel-Haenszel|Loss of efficacy (LOE) imputation defined as LOE drop-outs were treated as non-responders/all other participants had LOCF applied as primary analysis.||Sample size estimated based on moderate/severe rheumatoid arthritis(RA) trial. Study design included only moderate RA participants, thus a low disease activity estimate of 85% (ETN+MTX) vs 70% (MTX only) assumed, required 175 randomized participants in 3 treatments for a 90% power and Type I error of 0.05 to reject the null hypothesis of no ETN+MTX vs MTX only differences. More participants qualified for Period 2 than expected, Period 2 sample size roughly 15% larger than protocol-specified.||9.0|3.2|<0.0001
71055619|NCT01727726|141615493|OTHER||Mean Difference (Final Values)|-0.23||||0.1334|TWO_SIDED|95.0|-0.52|0.07|||MMRM|Mixed-model repeated measures (MMRM)||||0.07|-0.52|0.1334
71055620|NCT01727726|141615493|OTHER||Mean Difference (Final Values)|0.42||||0.0237|TWO_SIDED|95.0|0.06|0.78|||MMRM|Mixed-model repeated measures (MMRM)||||0.78|0.06|0.0237
71055621|NCT01727726|141615494|OTHER||Mean Difference (Final Values)|-1.53||||0.0001|TWO_SIDED|95.0|-2.29|-0.76|||MMRM|Mixed-model repeated measures (MMRM)||Phase B week 2||-0.76|-2.29|0.0001
71055622|NCT01727726|141615494|OTHER||Mean Difference (Final Values)|-1.22||||0.0103|TWO_SIDED|95.0|-2.15|-0.29|||MMRM|Mixed-model repeated measures (MMRM)||Phase B Week 2||-0.29|-2.15|0.0103
71055623|NCT01727726|141615494|OTHER||Mean Difference (Final Values)|-1.17||||0.0185|TWO_SIDED|95.0|-2.15|-0.2|||MMRM|Mixed-model repeated measures (MMRM)||Phase B week 4||-0.20|-2.15|0.0185
71055624|NCT01727726|141615494|OTHER||Mean Difference (Final Values)|-0.08||||0.8949|TWO_SIDED|95.0|-1.27|1.11|||MMRM|Mixed-model repeated measures (MMRM)||Phase B Week 4||1.11|-1.27|0.8949
71055625|NCT01727726|141615495|OTHER||Mean Difference (Final Values)|-0.15||||0.035|TWO_SIDED|95.0|-0.29|-0.01|||Cochran-Mantel-Haenszel|||CGI-Severity of Illness Scale Score||-0.01|-0.29|0.0350
71055626|NCT01727726|141615495|OTHER||Mean Difference (Final Values)|-0.05||||0.5601|TWO_SIDED|95.0|-0.22|0.12|||Cochran-Mantel-Haenszel|||CGI-Severity of Illness Scale Score||0.12|-0.22|0.5601
71055627|NCT01727726|141615495|OTHER||Mean Difference (Final Values)|-0.19||||0.0146|TWO_SIDED|95.0|-0.35|-0.04|||Cochran-Mantel-Haenszel|||CGI-Improvement Scale Score||-0.04|-0.35|0.0146
71055628|NCT01727726|141615495|OTHER||Mean Difference (Final Values)|-0.04||||0.7127|TWO_SIDED|95.0|-0.23|0.15|||Cochran-Mantel-Haenszel|||CGI-Improvement Scale Score||0.15|-0.23|0.7127
71055629|NCT01727726|141615496|OTHER||Ratio of response rate|1.49||||0.2242|TWO_SIDED|95.0|0.78|2.84|||Cochran-Mantel-Haenszel|||Phase B Week 6||2.84|0.78|0.2242
71055630|NCT01727726|141615496|OTHER||Ratio of Response Rate|1.26||||0.5998|TWO_SIDED|95.0|0.53|2.98|||Cochran-Mantel-Haenszel|||Phase B Week 6||2.98|0.53|0.5998
71055631|NCT01727726|141615497|OTHER||Ratio of Response Rate|1.52||||0.3321|TWO_SIDED|95.0|0.66|3.49|||Cochran-Mantel-Haenszel|||Phase B Week 6||3.49|0.66|0.3321
71055632|NCT01727726|141615497|OTHER||Ratio of Response Rate|0.51||||0.3917|TWO_SIDED|95.0|0.11|2.46|||Cochran-Mantel-Haenszel|||Phase B Week 6||2.46|0.11|0.3917
71055633|NCT01727726|141615498|OTHER||Ratio of Response Rate|1.35||||0.0032|TWO_SIDED|95.0|1.1|1.66|||Cochran-Mantel-Haenszel|||Phase B Week 6||1.66|1.10|0.0032
71055634|NCT01727726|141615498|OTHER||Ratio of Response Rate|1.24||||0.0898|TWO_SIDED|95.0|0.98|1.59|||Cochran-Mantel-Haenszel|||Phase B Week 6||1.59|0.98|0.0898
71055635|NCT01727726|141615500|OTHER||Mean Difference (Final Values)|0.16||||0.448|TWO_SIDED|95.0|-0.25|0.56|||MMRM|Mixed-model repeated measures (MMRM)||Work/School Score||0.56|-0.25|0.4480
71055636|NCT01727726|141615500|OTHER||Mean Difference (Final Values)|0.52||||0.038|TWO_SIDED|95.0|0.03|1.02|||MMRM|Mixed-model repeated measures (MMRM)||Work/School Score||1.02|0.03|0.0380
71055637|NCT01727726|141615500|OTHER||Mean Difference (Final Values)|-0.34||||0.0436|TWO_SIDED|95.0|-0.66|-0.01|||MMRM|Mixed-model repeated measures (MMRM)||Social Life Score||-0.01|-0.66|0.0436
71055638|NCT01727726|141615500|OTHER||Mean Difference (Final Values)|0.43||||0.035|TWO_SIDED|95.0|0.03|0.84|||MMRM|Mixed-model repeated measures (MMRM)||Social Life Score||0.84|0.03|0.0350
71055639|NCT01727726|141615500|OTHER||Mean Difference (Final Values)|-0.35||||0.0424|TWO_SIDED|95.0|-0.69|-0.01|||MMRM|Mixed-model repeated measures (MMRM)||Family Life Score||-0.01|-0.69|0.0424
71055640|NCT01727726|141615500|OTHER||Mean Difference (Final Values)|0.33||||0.123|TWO_SIDED|95.0|-0.09|0.75|||MMRM|Mixed-model repeated measures (MMRM)||Family Life Score||0.75|-0.09|0.1230
71055641|NCT04762277|141615501|OTHER||Mean Difference (Net)|-4.1|||||TWO_SIDED|95.0|-31.7|23.4|||||Difference of Least Squares Means was calculated as: Spesolimab-Placebo.|MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to TNFi-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit. The unstructured covariance structure was used to model the within patient measurements. To estimate denominator degrees of freedom the Kenward-Roger approximation was used.||23.4|-31.7|
70933497|NCT00975585|141368158|NON_INFERIORITY_OR_EQUIVALENCE|Margin = 0.5|Mean Difference (Final Values)|-0.068|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|98.2|-0.068|0.008|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by site interaction as fixed effects, subject and eye nested within subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses are non-inferior in bulbar redness to lotrafilcon B contact lenses after two weeks of wear.||0.008|-0.068|
70933498|NCT00975585|141368159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.411|STANDARD_ERROR_OF_MEAN|0.124|||TWO_SIDED|98.2|-0.411|-0.117|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by stie interaction as fixed effects, subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses have less frequency of dryness than lotrafilcon B contact lenes after two weeks of wear.||-0.117|-0.411|
70933499|NCT00853580|141368211|SUPERIORITY|||||||0.51|||||||ANCOVA|||||||0.51
70933500|NCT00853580|141368212|SUPERIORITY|||||||0.33|||||||ANCOVA|||||||0.33
70933501|NCT00853580|141368213|SUPERIORITY|||||||0.86|||||||ANCOVA|||||||0.86
70933502|NCT00853580|141368214|SUPERIORITY|||||||0.04|||||||ANCOVA|||||||0.04
71055642|NCT04762277|141615502|OTHER||Mean Difference (Net)|-96.6|||||TWO_SIDED|95.0|-154.5|-38.8|||||Difference of Least Squares Means was calculated as: Spesolimab-Placebo.|MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to TNFi-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit. The unstructured covariance structure was used to model the within patient measurements. To estimate denominator degrees of freedom the Kenward-Roger approximation was used.||-38.8|-154.5|
71055643|NCT04762277|141615503|OTHER||Risk Difference (RD)|0.138|||||TWO_SIDED|95.0|-0.129|0.339|||||Risk difference was calculated as: Spesolimab - Placebo. 95% Confidence Interval (CI) for treatment difference is calculated by Chan and Zhang method.|The difference in the proportion of patients with a response between Spesolimab and placebo was analysed using a logistic regression model. The model included treatment and stratification factor (tumor necrosis factor inhibitor (TNFi)-naive population versus TNFi-failure population) as two categorical variables.||0.339|-0.129|
70933503|NCT00853580|141368215|SUPERIORITY|||||||0.33|||||||ANCOVA|||||||0.33
70933504|NCT00853580|141368216|SUPERIORITY|||||||0.99|||||||ANCOVA|||||||0.99
70933505|NCT00853580|141368217|SUPERIORITY|||||||0.9|||||||ANCOVA|||||||0.90
70933506|NCT00853580|141368218|SUPERIORITY|||||||0.37|||||||ANCOVA|||||||0.37
70933507|NCT00853580|141368219|SUPERIORITY|||||||0.49|||||||ANCOVA|||||||0.49
70933508|NCT00853580|141368220|SUPERIORITY|||||||0.86|||||||ANCOVA|||||||0.86
70933509|NCT00853580|141368221|SUPERIORITY|||||||0.09|||||||ANCOVA|||||||0.09
70933510|NCT00853580|141368222|SUPERIORITY|||||||0.37|||||||ANCOVA|||||||0.37
70933511|NCT00853580|141368223|SUPERIORITY|||||||0.18|||||||ANCOVA|||||||0.18
70933512|NCT00853580|141368224|SUPERIORITY|||||||0.88|||||||ANCOVA|||||||0.88
70933513|NCT00853580|141368225|SUPERIORITY|||||||0.25|||||||ANCOVA|||||||0.25
70933514|NCT00853580|141368226|SUPERIORITY|||||||0.2|||||||ANCOVA|||||||0.20
70933515|NCT00853580|141368227|SUPERIORITY|||||||0.5|||||||ANCOVA|||||||0.50
71022396|NCT01706198|141552770|OTHER||Adjusted Odds Ratio|1.96|||<|0.001|TWO_SIDED|95.0|1.7|2.25||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 24 has been presented.|||2.25|1.70|<0.001
71022397|NCT01706198|141552770|OTHER||Adjusted Odds Ratio|1.79|||<|0.001|TWO_SIDED|95.0|1.56|2.06||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 40 has been presented.|||2.06|1.56|<0.001
71022398|NCT01706198|141552770|OTHER||Adjusted Odds Ratio|1.95|||<|0.001|TWO_SIDED|95.0|1.69|2.24||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 52 has been presented.|||2.24|1.69|<0.001
71022399|NCT01706198|141552771|OTHER||Adjusted Odds Ratio|2.28|||<|0.001|TWO_SIDED|95.0|1.98|2.62||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 12 has been presented.|||2.62|1.98|<0.001
70933516|NCT00853580|141368228|SUPERIORITY|||||||0.33|||||||ANCOVA|||||||0.33
70933517|NCT00853580|141368229|SUPERIORITY|||||||0.3|||||||ANCOVA|||||||0.30
70933518|NCT00853580|141368230|SUPERIORITY|||||||0.73|||||||ANCOVA|||||||0.73
70933519|NCT01968967|141368235|SUPERIORITY_OR_OTHER||LS Mean Difference|-56.2|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-58.3|-54.0|||MMRM|||Least square (LS) mean difference and associated 95 percent (%) confidence interval (CI), and p-value were derived from mixed effect model repeat measurement (MMRM) model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-54.0|-58.3|<0.001
70933520|NCT01968967|141368236|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.0|STANDARD_ERROR_OF_MEAN|0.76|<|0.001|TWO_SIDED|95.0|-36.5|-33.5|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-33.5|-36.5|<0.001
70933521|NCT01968967|141368236|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.6|STANDARD_ERROR_OF_MEAN|0.89|||TWO_SIDED|95.0|-33.3|-29.8||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-29.8|-33.3|
71055644|NCT04762277|141615504|OTHER||Mean Difference (Net)|-13.9|||||TWO_SIDED|95.0|-25.6|-2.3|||||Difference of Least Squares Means was calculated as: Spesolimab-Placebo.|MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to TNFi-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit. The unstructured covariance structure was used to model the within patient measurements. To estimate denominator degrees of freedom the Kenward-Roger approximation was used.||-2.3|-25.6|
71055645|NCT04762277|141615505|OTHER||Mean Difference (Net)|-19.8|||||TWO_SIDED|95.0|-36.9|-2.7|||||Difference of Least Squares Means was calculated as : Spesolimab- Placebo.|MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to TNFi-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit. The unstructured covariance structure was used to model the within patient measurements. To estimate denominator degrees of freedom the Kenward-Roger approximation was used.||-2.7|-36.9|
71055646|NCT04762277|141615506|OTHER||Risk Difference (RD)|0.057|||||TWO_SIDED|95.0|-0.132|0.186|||||Risk difference was calculated as: Spesolimab-Placebo. 95% Confidence Interval (CI) for treatment difference is calculated by Chan and Zhang method.|The difference in the proportion of patients with a response between Spesolimab and placebo was analysed using a logistic regression model. The model included treatment and stratification factor (tumor necrosis factor inhibitor (TNFi)-naive population versus TNFi-failure population) as two categorical variables.||0.186|-0.132|
71055647|NCT04762277|141615507|OTHER||Risk Difference (RD)|0.17|||||TWO_SIDED|95.0|-0.067|0.338|||||Risk Difference was calculated as: Spesolimab - Placebo. 95% Confidence Interval (CI) for treatment difference was calculated by Chan and Zhang method.|The difference in the proportion of patients with a response between Spesolimab and placebo was analysed using a logistic regression model. The model included treatment and stratification factor (tumor necrosis factor inhibitor (TNFi)-naive population versus TNFi-failure population) as two categorical variables.||0.338|-0.067|
71055648|NCT04762277|141615508|OTHER||Risk Difference (RD)|0.183|||||TWO_SIDED|95.0|-0.079|0.375|||||Risk Difference was calculated as: Spesolimab - Placebo. 95% Confidence Interval (CI) for treatment difference was calculated by Chan and Zhang method.|The difference in the proportion of patients with a response between Spesolimab and placebo was analysed using a logistic regression model. The model included treatment and stratification factor (tumor necrosis factor inhibitor (TNFi)-naive population versus TNFi-failure population) as two categorical variables.||0.375|-0.079|
71055649|NCT04762277|141615509|OTHER||Risk Difference (RD)|-0.091|||||TWO_SIDED|95.0|-0.331|0.089|||||Risk Difference was calculated as: Spesolimab - Placebo. 95% Confidence Interval (CI) for treatment difference was calculated by Chan and Zhang method.|The difference in the proportion of patients with a response between Spesolimab and placebo was analysed using a logistic regression model. The model included treatment and stratification factor (tumor necrosis factor inhibitor (TNFi)-naive population versus TNFi-failure population) as two categorical variables.||0.089|-0.331|
71055650|NCT04762277|141615510|OTHER||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-4.4|4.3|||||Difference of Least Squares Means was calculated as: Spesolimab-Placebo.|MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to TNFi-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit. The unstructured covariance structure was used to model the within patient measurements. To estimate denominator degrees of freedom the Kenward-Roger approximation was used.||4.3|-4.4|
71055651|NCT04762277|141615511|OTHER||Mean Difference (Net)|-1.3|||||TWO_SIDED|95.0|-9.5|6.9|||||Difference of Least Squares Means was calculated as: Spesolimab-Placebo.|MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to TNFi-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit. The unstructured covariance structure was used to model the within patient measurements. To estimate denominator degrees of freedom the Kenward-Roger approximation was used.||6.9|-9.5|
71055652|NCT00642278|141615517|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|-0.747|-0.148||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.148|-0.747|<0.001
71055653|NCT00642278|141615517|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|-0.804|-0.207||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.207|-0.804|<0.001
71055654|NCT00642278|141615517|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|-0.841|-0.244||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.244|-0.841|<0.001
71055655|NCT00642278|141615517|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.117|<|0.001|TWO_SIDED|95.0|-1.006|-0.405||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.405|-1.006|<0.001
71055656|NCT00642278|141615517|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|-1.029|-0.432||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.432|-1.029|<0.001
71055657|NCT00642278|141615517|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|-0.862|-0.265||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.265|-0.862|<0.001
71055658|NCT00642278|141615518|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.27||0.001|TWO_SIDED|95.0|-1.39|-0.34|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.34|-1.39|0.001
71055659|NCT00642278|141615518|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.98|-0.92|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.92|-1.98|<0.001
70933522|NCT01968967|141368236|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.7|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|-26.6|-22.8||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-22.8|-26.6|
70933523|NCT01968967|141368237|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.8|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-52.9|-48.8|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-48.8|-52.9|<0.001
71055660|NCT00642278|141615518|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.33|-1.27|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-1.27|-2.33|<0.001
71055661|NCT00642278|141615518|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.32|-1.26|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-1.26|-2.32|<0.001
71055662|NCT00642278|141615518|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.25|-1.19|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-1.19|-2.25|<0.001
71055663|NCT00642278|141615518|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.51|-0.46|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.46|-1.51|<0.001
71055664|NCT00642278|141615520|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|36.1|STANDARD_ERROR_OF_MEAN|5.1|<|0.001|TWO_SIDED|95.0|26.07|46.13|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||46.13|26.07|<0.001
71055665|NCT00642278|141615520|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|49.3|STANDARD_ERROR_OF_MEAN|5.13|<|0.001|TWO_SIDED|95.0|39.17|59.34|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||59.34|39.17|<0.001
71055666|NCT00642278|141615520|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|48.2|STANDARD_ERROR_OF_MEAN|5.2|<|0.001|TWO_SIDED|95.0|37.98|58.42|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||58.42|37.98|<0.001
71055667|NCT00642278|141615520|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|49.0|STANDARD_ERROR_OF_MEAN|5.11|<|0.001|TWO_SIDED|95.0|38.91|59.01|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||59.01|38.91|<0.001
71055668|NCT00642278|141615520|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|60.3|STANDARD_ERROR_OF_MEAN|5.13|<|0.001|TWO_SIDED|95.0|50.17|70.35|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||70.35|50.17|<0.001
71055669|NCT00642278|141615520|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|5.09||0.513|TWO_SIDED|95.0|-13.33|6.67|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||6.67|-13.33|0.513
71055670|NCT00642278|141615522|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.5||0.009|TWO_SIDED|95.0|-2.2|-0.3|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.3|-2.2|0.009
71055671|NCT00642278|141615522|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.5||0.002|TWO_SIDED|95.0|-2.5|-0.6|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.6|-2.5|0.002
71055672|NCT00642278|141615522|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-2.6|-0.7|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and mixed meal tolerance test.||||-0.7|-2.6|<0.001
71055673|NCT00642278|141615522|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.3|-1.4|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-1.4|-3.3|<0.001
71055674|NCT00642278|141615522|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.3|-1.4|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-1.4|-3.3|<0.001
71055675|NCT00642278|141615522|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.5||0.371|TWO_SIDED|95.0|-0.5|1.4|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||1.4|-0.5|0.371
71055676|NCT03713619|141615528|SUPERIORITY||Odds Ratio, log|1.75||||0.007|TWO_SIDED|95.0|1.12|2.73|||Regression, Logistic|||Logistic regression analysis of HiSCR50 response at Week 16 (multiple imputation)||2.73|1.12|0.0070
71055677|NCT03713619|141615528|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0418|TWO_SIDED|95.0|0.95|2.32|||Regression, Logistic|||Logistic regression analysis of HiSCR50 response at Week 16 (multiple imputation)||2.32|0.95|0.0418
71055678|NCT03713619|141615529|SUPERIORITY||Least square Mean Difference|-23.05|||<|0.0001|TWO_SIDED|95.0|-33.9|-12.21|||ANCOVA|||Analysis of covariance of percentage change from baseline in AN count at Week 16 (multiple imputation)||-12.21|-33.90|<0.0001
71055679|NCT03713619|141615529|SUPERIORITY||Least Square Mean difference|-18.46||||0.0004|TWO_SIDED|95.0|-29.32|-7.6|||ANCOVA|||Analysis of covariance of percentage change from baseline in AN count at Week 16 (multiple imputation)||-7.60|-29.32|0.0004
70933524|NCT01968967|141368237|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.1|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|95.0|-48.5|-43.8||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-43.8|-48.5|
70941657|NCT04748445|141383934|OTHER||Slope|0.02851|STANDARD_ERROR_OF_MEAN|9.96||0.7752|TWO_SIDED|90.0|-0.1365|0.1936|||Mixed Models Analysis|||MM\_MFCC mean 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1936|-0.1365|0.7752
71055680|NCT03713619|141615530|SUPERIORITY||Odds Ratio, log|0.42||||0.001|TWO_SIDED|95.0|0.25|0.73|||Regression, Logistic|||Logistic regression analysis of Flare over 16 weeks (multiple imputation)||0.73|0.25|0.0010
71055681|NCT03713619|141615530|SUPERIORITY||Odds Ratio (OR)|0.71||||0.0926|TWO_SIDED|95.0|0.43|1.17|||Regression, Logistic|||Logistic regression analysis of Flare over 16 weeks (multiple imputation)||1.17|0.43|0.0926
71055682|NCT03713619|141615531|SUPERIORITY||Odds Ratio (OR)|1.84||||0.0248|TWO_SIDED|95.0|1.0|3.4|||Regression, Logistic|||Logistic regression analysis of skin pain/NRS30 response at Week 16 (pooled data, multiple imputation)||3.40|1.00|0.0248
71055683|NCT03713619|141615531|SUPERIORITY||Odds Ratio, log|1.77||||0.0044|TWO_SIDED|95.0|1.15|2.0|||Regression, Logistic|||Logistic regression analysis of skin pain/NRS30 response at Week 16 (pooled data, multiple imputation)||2.0|1.15|0.0044
71055684|NCT06281171|141615532|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||||||<.001
71055685|NCT06281171|141615533|SUPERIORITY|||||||0.996|||||||t-test, 2 sided|||||||.996
71055686|NCT06281171|141615534|SUPERIORITY|||||||0.782|||||||t-test, 2 sided|||||||.782
71055687|NCT06281171|141615535|SUPERIORITY|||||||0.54|||||||Regression, Linear|||||||0.54
71055688|NCT06281171|141615536|SUPERIORITY|||||||0.03|||||||Regression, Linear|||||||0.03
71055689|NCT06281171|141615537|SUPERIORITY|||||||0.3|||||||Regression, Linear|||||||0.30
71055690|NCT06281171|141615538|SUPERIORITY|||||||0.06|||||||Regression, Linear|||||||0.06
71055691|NCT02552212|141615539|OTHER||Odds Ratio (OR)|15.231|||<|0.001|TWO_SIDED|95.0|7.336|31.623|||Regression, Logistic|||Odds ratio: CZP/Placebo and p-value were calculated using logistic regression with factors for treatment, region and Magnetic Resonance Imaging/C- Reactive Protein (MRI/CRP) classification.||31.623|7.336|<0.001
71055692|NCT02552212|141615540|OTHER||Odds Ratio (OR)|7.436|||<|0.001|TWO_SIDED|95.0|4.127|13.401|||Regression, Logistic|||Odds ratio: CZP/Placebo and p-value were calculated using logistic regression with factors for treatment, region and MRI/CRP classification.||13.401|4.127|<0.001
71055693|NCT02552212|141615550|OTHER||Odds Ratio (OR)|7.359|||<|0.001|TWO_SIDED|95.0|4.286|12.636|||Regression, Logistic|||Odds ratio: CZP/Placebo and p-value were calculated using logistic regression with factors for treatment, region MRI/CRP classification.||12.636|4.286|<0.001
71055694|NCT02552212|141615551|OTHER||Difference|-1.696|||<|0.001|TWO_SIDED|95.0|-2.11|-1.282|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-1.282|-2.110|<0.001
71055695|NCT02552212|141615552|OTHER||Difference|-1.585|||<|0.0001|TWO_SIDED|95.0|-2.132|-1.038|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-1.038|-2.132|<0.0001
71055696|NCT02552212|141615553|OTHER||Difference|-1.819|||<|0.001|TWO_SIDED|95.0|-2.25|-1.388|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-1.388|-2.250|<0.001
71055697|NCT02552212|141615554|OTHER||Difference|-1.29|||<|0.001|TWO_SIDED|95.0|-1.909|-0.672|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-0.672|-1.909|<0.001
71055698|NCT02552212|141615555|OTHER||Difference|-4.8687|||<|0.001|TWO_SIDED|95.0|-6.4014|-3.336|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-3.3360|-6.4014|<0.001
71055699|NCT02552212|141615556|OTHER||Odds Ratio (OR)|6.223|||<|0.001|TWO_SIDED|95.0|3.8|10.191|||Regression, Logistic|||Odds ratio: CZP/Placebo and p-value were calculated using logistic regression with factors for treatment, region and MRI/CRP classification.||10.191|3.800|<0.001
71055700|NCT02552212|141615557|OTHER||Difference|-0.183|||<|0.001|TWO_SIDED|95.0|-0.25|-0.117|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-0.117|-0.250|<0.001
71055701|NCT02552212|141615565|OTHER||Difference|-1.9|||<|0.001|TWO_SIDED|95.0|-2.62|-1.18|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-1.18|-2.62|<0.001
71055702|NCT02552212|141615566|OTHER||Odds Ratio (OR)|0.484|||=|0.247|TWO_SIDED|95.0|0.142|1.653|||Regression, Logistic|||Odds ratio: CZP/PBO and p-value were calculated using logistic regression with factors for treatment, region and MRI/CRP classification.||1.653|0.142|=0.247
71055703|NCT03020589|141615570|SUPERIORITY||Risk Ratio (RR)|1.27||||0.58|TWO_SIDED|95.0|0.67|2.05|||Fisher Exact|||||2.05|0.67|0.58
71055704|NCT03020589|141615571|SUPERIORITY||Risk Ratio (RR)|1.26||||0.46|TWO_SIDED|95.0|0.72|2.02|||Fisher Exact|||||2.02|0.72|0.46
71055705|NCT00197496|141615607|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.3|||<|0.05|TWO_SIDED|95.0|-72.1|19.6|||Regression, Linear|||||19.6|-72.1|<0.05
71055706|NCT00197496|141615610|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.8||||0.4|TWO_SIDED|95.0|-3.6|9.2|||Regression, Linear|||||9.2|-3.6|0.40
71055707|NCT00213135|141615679|SUPERIORITY_OR_OTHER||Relative Risk|0.43|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|0.35|0.54|||Wald Chi-square test|||||0.54|0.35|<0.001
71055708|NCT00213135|141615679|SUPERIORITY_OR_OTHER||Relative Risk|0.43|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|0.34|0.54|||Wald Chi-square test|||||0.54|0.34|<0.001
71055709|NCT02500043|141615718|OTHER||Hazard Ratio (HR)|0.6917||||0.0003|TWO_SIDED|95.0|0.5597|0.8548||One-sided P-Value.|Log Rank|||TAS-102+BSC and Placebo+BSC were compared using the stratified log-rank test using the 3 randomization stratification factors (region, ECOG performance status, and prior treatment with ramucirumab). The hazard ratio was estimated using a stratified Cox's proportional hazard (CPH) model and survival was summarized using Kaplan Meier estimates.||0.8548|0.5597|0.0003
71055710|NCT02500043|141615719|OTHER||Hazard Ratio (HR)|0.5723|||||TWO_SIDED|95.0|0.4674|0.7008||||||TAS-102+BSC and Placebo+BSC were compared using the stratified log-rank test using the 3 randomization stratification factors (region, ECOG performance status, and prior treatment with ramucirumab). The hazard ratio was estimated using a stratified CPH model and survival was summarized using Kaplan Meier estimates.||0.7008|0.4674|
70933525|NCT01968967|141368237|SUPERIORITY_OR_OTHER||LS Mean Difference|-36.1|STANDARD_ERROR_OF_MEAN|1.28|||TWO_SIDED|95.0|-38.6|-33.6||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-33.6|-38.6|
71022400|NCT01706198|141552771|OTHER||Adjusted Odds Ratio|2.09|||<|0.001|TWO_SIDED|95.0|1.81|2.41||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 24 has been presented.|||2.41|1.81|<0.001
71022401|NCT01706198|141552771|OTHER||Adjusted Odds Ratio|1.76|||<|0.001|TWO_SIDED|95.0|1.53|2.02||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 40 has been presented.|||2.02|1.53|<0.001
71022402|NCT01706198|141552771|OTHER||Adjusted Odds Ratio|1.91|||<|0.001|TWO_SIDED|95.0|1.66|2.21||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 52 has been presented.|||2.21|1.66|<0.001
71022403|NCT01706198|141552772|OTHER||Mean Difference (Net)|1.54|||<|0.001|TWO_SIDED|95.0|1.3|1.77||MMRM adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, randomized treatment-by-Baseline ACT total score interaction, gender, age, visit and randomized treatment by visit interaction.|Mixed Model Repeated Measures (MMRM)||Treatment difference of FF/VI versus Usual Care at Week 12 has been presented.|||1.77|1.30|<0.001
71022404|NCT01706198|141552772|OTHER||Mean Difference (Net)|1.5|||<|0.001|TWO_SIDED|95.0|1.25|1.76||MMRM adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, randomized treatment-by-Baseline ACT total score interaction, gender, age, visit and randomized treatment by visit interaction.|MMRM||Treatment difference of FF/VI versus Usual Care at Week 24 has been presented.|||1.76|1.25|<0.001
71022405|NCT01706198|141552772|OTHER||Mean Difference (Net)|1.37|||<|0.001|TWO_SIDED|95.0|1.11|1.63||MMRM adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, randomized treatment-by-Baseline ACT total score interaction, gender, age, visit and randomized treatment by visit interaction.|MMRM||Treatment difference of FF/VI versus Usual Care at Week 40 has been presented.|||1.63|1.11|<0.001
71022406|NCT01706198|141552772|OTHER||Mean Difference (Net)|1.5|||<|0.001|TWO_SIDED|95.0|1.24|1.76||MMRM adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, randomized treatment-by-Baseline ACT total score interaction, gender, age, visit and randomized treatment by visit interaction.|MMRM||Treatment difference of FF/VI versus Usual Care at Week 52 has been presented.|||1.76|1.24|<0.001
71022407|NCT01706198|141552774|OTHER||Ratio|1.03||||0.786|TWO_SIDED|95.0|0.83|1.28||GLM assuming negative binomial distribution (NBD) adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age|Generalized Linear Model (GLM)||Ratio comparing FF/VI with Usual Care has been presented.|||1.28|0.83|0.786
71055711|NCT03301649|141615736|EQUIVALENCE|Therapeutic equivalence was demonstrated if 90% CI of percentage difference between generic ivermectin lotion and sklice (ivermectin) lotion group was within the range (-20%, +20%).|Difference in percentage of participants|1.9|||||TWO_SIDED|90.0|-3.9|7.8||||||If the 90% confidence interval (CI) for the absolute difference between the percentage of participants who were considered a treatment success in the generic ivermectin lotion and sklice (ivermectin) lotion was contained within the range (-20%, +20%) then therapeutic equivalence of the generic ivermectin lotion and sklice (ivermectin) lotion was considered to have been demonstrated.||7.8|-3.9|
71055712|NCT03301649|141615737|SUPERIORITY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using Cochran- Mantel-Haenszel test, stratified by clinical site in mITT population (using last observation carried forward \[LOCF\] method).||||<0.0001
71055713|NCT03301649|141615737|SUPERIORITY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using Cochran- Mantel-Haenszel test, stratified by clinical site in mITT population (using LOCF method).||||<0.0001
71055714|NCT03301649|141615738|EQUIVALENCE|Therapeutic equivalence was demonstrated if 90% CI of percentage difference between generic ivermectin lotion and sklice (ivermectin) lotion group was within the range (-20%, +20%).|Difference in percentage of participants|0.9|||||TWO_SIDED|90.0|-2.6|4.5||||||If the 90% CI for the absolute difference between the percentage of participants who were considered a treatment success in the generic ivermectin lotion and sklice (ivermectin) lotion was contained within the range (-20%, +20%) then therapeutic equivalence of the generic ivermectin lotion and sklice (ivermectin) lotion was considered to have been demonstrated.||4.5|-2.6|
71055715|NCT03301649|141615739|SUPERIORITY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using Cochran- Mantel-Haenszel test, stratified by clinical site in mITT population (using LOCF method).||||<0.0001
71055716|NCT03301649|141615739|SUPERIORITY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using Cochran- Mantel-Haenszel test, stratified by clinical site in mITT population (using LOCF method).||||<0.0001
71055717|NCT01564537|141615740|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.742||||0.012|TWO_SIDED|95.0|0.587|0.939|||Log Rank||HR is estimated from Cox Regression.|||0.939|0.587|0.012
71055718|NCT01564537|141615741|SUPERIORITY||Hazard Ratio (HR)|0.939|||=|0.495|TWO_SIDED|95.0|0.784|1.125|||Log Rank||HR:estimated from Cox Regression with stratification factors: prior therapies, proteasome inhibitor, and ISS Stage at Screening with treatment as factor in model. \<1 hazard ratio for treatment=better prevention of death in drug arm vs control.|||1.125|0.784|=0.495
71022408|NCT01706198|141552775|OTHER||Ratio|1.02||||0.461|TWO_SIDED|95.0|0.97|1.08||GLM assuming NBD adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age|Generalized Linear Model (GLM)||Ratio comparing FF/VI with Usual Care has been presented.|||1.08|0.97|0.461
70933526|NCT01968967|141368238|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.1|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-52.1|-48.0|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-48.0|-52.1|<0.001
70933527|NCT01968967|141368238|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.5|STANDARD_ERROR_OF_MEAN|1.22|||TWO_SIDED|95.0|-47.9|-43.1||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-43.1|-47.9|
70933528|NCT01968967|141368238|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.9|STANDARD_ERROR_OF_MEAN|1.33|||TWO_SIDED|95.0|-38.5|-33.3||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-33.3|-38.5|
70933529|NCT01968967|141368239|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.7|STANDARD_ERROR_OF_MEAN|1.29|<|0.001|TWO_SIDED|95.0|-60.2|-55.2|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-55.2|-60.2|<0.001
70933530|NCT01968967|141368239|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.1|STANDARD_ERROR_OF_MEAN|1.55|||TWO_SIDED|95.0|-56.1|-50.0||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-50.0|-56.1|
70933531|NCT01968967|141368239|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.8|STANDARD_ERROR_OF_MEAN|1.7|||TWO_SIDED|95.0|-46.2|-39.5||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-39.5|-46.2|
70933532|NCT01968967|141368240|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.8|STANDARD_ERROR_OF_MEAN|2.09|<|0.001|TWO_SIDED|95.0|-55.9|-47.7|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-47.7|-55.9|<0.001
70933533|NCT01968967|141368240|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.0|STANDARD_ERROR_OF_MEAN|2.61|||TWO_SIDED|95.0|-49.1|-38.8||||||Week 24: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-38.8|-49.1|
70933534|NCT01968967|141368240|SUPERIORITY_OR_OTHER||LS Mean Difference|-34.6|STANDARD_ERROR_OF_MEAN|2.83|||TWO_SIDED|95.0|-40.2|-29.0||||||Week 52: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-29.0|-40.2|
70933535|NCT01968967|141368241|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.5|STANDARD_ERROR_OF_MEAN|3.04|<|0.001|TWO_SIDED|95.0|-34.4|-22.5|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-22.5|-34.4|<0.001
70933536|NCT01968967|141368241|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.1|STANDARD_ERROR_OF_MEAN|4.86|||TWO_SIDED|95.0|-40.6|-21.5||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-21.5|-40.6|
70933537|NCT01968967|141368241|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.3|STANDARD_ERROR_OF_MEAN|5.89|||TWO_SIDED|95.0|-36.8|-13.7||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-13.7|-36.8|
71107348|NCT00565409|141720999|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.3805|TWO_SIDED|95.0|0.7|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|LOE imputation defined as LOE drop-outs were treated as non-responders and all other participants had LOCF applied as primary analysis.||||2.0|0.7|0.3805
70933538|NCT01968967|141368242|SUPERIORITY_OR_OTHER||LS Mean Difference|5.8|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|4.5|7.0|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||7.0|4.5|<0.001
70933539|NCT01968967|141368242|SUPERIORITY_OR_OTHER||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|95.0|4.2|6.8||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||6.8|4.2|
70933540|NCT01968967|141368242|SUPERIORITY_OR_OTHER||LS Mean Difference|5.2|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|3.7|6.7||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||6.7|3.7|
70933541|NCT01968967|141368243|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.7|STANDARD_ERROR_OF_MEAN|1.34|||TWO_SIDED|95.0|-53.3|-48.0||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-48.0|-53.3|
70933542|NCT01968967|141368243|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.7|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|95.0|-43.5|-37.8||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-37.8|-43.5|
70933543|NCT01968967|141368244|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.6|STANDARD_ERROR_OF_MEAN|1.73|||TWO_SIDED|95.0|-20.0|-13.2||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-13.2|-20.0|
70933544|NCT01968967|141368244|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|2.05|||TWO_SIDED|95.0|-20.7|-12.6||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-12.6|-20.7|
70933545|NCT01968967|141368244|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.8|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|-16.5|-9.0||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-9.0|-16.5|
71022409|NCT01706198|141552777|OTHER||Ratio|0.99||||0.822|TWO_SIDED|95.0|0.91|1.08||GLM assuming NBD adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age|Generalized Linear Model (GLM)||Ratio comparing FF/VI with Usual Care has been presented.|||1.08|0.91|0.822
71022410|NCT01706198|141552778|OTHER||Ratio|1.1|||<|0.001|TWO_SIDED|95.0|1.05|1.15||GLM assuming NBD adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age|Generalized Linear Model (GLM)||Ratio comparing FF/VI with Usual Care has been presented.|||1.15|1.05|<0.001
71022411|NCT01706198|141552780|OTHER||Ratio|0.98||||0.697|TWO_SIDED|95.0|0.88|1.09||GLM assuming NBD adjusted for randomized treatment; asthma maintenance therapy and ACT total score at Baseline per randomization stratification; number of severe asthma exacerbations in previous year prior to randomization categorized; gender \& age|Generalized Linear Model (GLM)||Ratio comparing FF/VI with Usual Care has been presented.|||1.09|0.88|0.697
71022412|NCT01706198|141552781|OTHER||Hazard Ratio (HR)|0.96||||0.504|TWO_SIDED|95.0|0.86|1.07||Cox proportional hazards model with randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age as covariates|Cox proportional hazards model||A hazard ratio \<1 indicated a lower risk with FF/VI compared with Usual Care|||1.07|0.86|0.504
71022413|NCT01706198|141552782|OTHER||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.1|-0.5||ANCOVA adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender,age \& number of salbutamol inhalers in year prior to randomization|ANCOVA||Difference of FF/VI versus Usual Care has been presented.|||-0.5|-1.1|<0.001
71055719|NCT01564537|141615742|SUPERIORITY||Hazard Ratio (HR)|0.916|||=|0.764|TWO_SIDED|95.0|0.516|1.626|||Log Rank||HR:estimated from Cox Regression with stratification factors: prior therapies, proteasome inhibitor, and ISS Stage at Screening with treatment as factor in model. \<1 hazard ratio for treatment=better prevention of death in drug arm vs control.|||1.626|0.516|=0.764
71055720|NCT01564537|141615754|SUPERIORITY||Odds Ratio (OR)|1.3|||=|0.332|TWO_SIDED|95.0|0.69|2.45||P-value is from Cochran-Mantel-Haenszel stratified by: prior therapies (1, 2 or 3), proteasome inhibitor (exposed, naïve), and ISS Stage at Screening (I or II, III).|Cochran-Mantel-Haenszel||Odds ratio is from logistic regression model with prognostic factors: prior therapies (1, 2 or 3), proteasome inhibitor (exposed, naïve),and ISS Stage at Screening (I or II, III). Odds ratio \> 1 favors Ixazomib.|||2.45|0.69|=0.332
71055721|NCT01635218|141615755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.05|TWO_SIDED|95.0|3.1|7.0||The ANOVA result (p\<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA|||||7.0|3.1|<0.05
71055722|NCT01635218|141615755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|0.81|<|0.05|TWO_SIDED|95.0|1.31|5.25||The ANOVA result (p\<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA|||||5.25|1.31|<0.05
71022414|NCT01706198|141552783|OTHER||Hazard Ratio (HR)|1.23|||<|0.001|TWO_SIDED|95.0|1.09|1.38||Cox proportional hazards model with randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age as covariates|Cox proportional hazards model||Hazard ratio for FF/VI versus Usual Care has been presented|||1.38|1.09|<0.001
71022415|NCT01706198|141552784|OTHER||Adjusted Odds Ratio|1.79|||<|0.001|TWO_SIDED|95.0|1.55|2.06||Logistic regression adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender, age and Baseline score.|Regression, Logistic||Adjusted odds ratio of FF/VI with Usual Care has been presented.|||2.06|1.55|<0.001
71055723|NCT01635218|141615756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4|STANDARD_ERROR_OF_MEAN|1.71||0.14|TWO_SIDED|95.0|-0.73|7.61||The statistical significant ANOVA result (p\<0.05) suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA|||||7.61|-0.73|0.14
71055724|NCT01635218|141615756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.28|STANDARD_ERROR_OF_MEAN|1.73||0.99|TWO_SIDED|95.0|-2.93|5.5||The ANOVA result (p\<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA|||||5.5|-2.93|0.99
70933546|NCT01968967|141368245|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|2.4|4.3||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||4.3|2.4|
71107349|NCT00565409|141720999|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.81|||<|0.0001|TWO_SIDED|95.0|3.0|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|LOE imputation defined as LOE drop-outs were treated as non-responders and all other participants had LOCF applied as primary analysis.||||7.6|3.0|<0.0001
71107350|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.11||||0.0853|TWO_SIDED|95.0|0.5|21.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Low Disease Activity||21.4|0.5|0.0853
70933547|NCT01968967|141368245|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|95.0|2.5|4.5||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||4.5|2.5|
70933548|NCT01968967|141368245|SUPERIORITY_OR_OTHER||LS Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|95.0|2.7|4.9||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||4.9|2.7|
71055725|NCT01635218|141615757|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.11|||<|0.05|TWO_SIDED|95.0|0.03|0.34|||Chi-squared|||||0.34|0.03|<0.05
71055726|NCT01635218|141615757|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.19|||<|0.05|TWO_SIDED|95.0|0.06|0.56|||Chi-squared|||||0.56|0.06|<0.05
71055727|NCT01635218|141615758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|2.42||0.002|TWO_SIDED|95.0|2.72|14.52||The ANOVA result (p\<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA|||||14.52|2.72|0.002
71055728|NCT01635218|141615758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6|STANDARD_ERROR_OF_MEAN|2.37||0.424|TWO_SIDED|95.0|-2.33|9.6||The ANOVA result (p\<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA|||||9.6|-2.33|0.424
71055729|NCT01635218|141615759|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.26||||0.1||95.0|0.05|1.32|||Chi-squared|||||1.32|0.05|0.10
71055730|NCT01635218|141615759|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||0.11|TWO_SIDED|95.0|0.05|1.39|||Chi-squared|||||1.39|0.05|0.11
71055731|NCT03262038|141615772|SUPERIORITY|||||||0.412|||||||Chi-squared|||||||.412
71055732|NCT03262038|141615773|SUPERIORITY|||||||0.633|||||||Chi-squared|||||||.633
71055733|NCT03262038|141615774|SUPERIORITY|||||||0.007|||||||Chi-squared|||||||.007
71055734|NCT03262038|141615775|SUPERIORITY|||||||0.634|||||||Chi-squared|||||||.634
71055735|NCT00094861|141615780|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.8553||||0.355||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants with no assessments were assumed as having grade ≥ 2 dysphagia in hypothesis testing.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.3550
71055736|NCT00094861|141615781|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.9936||||0.3189||95.0||||Generalized Cochran-Mantel-Haenszel test for mean score difference using modified ridit score.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.3189
71055737|NCT00094861|141615782|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.437||||0.5086||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants with no assessments were assumed as having grade 5 dysphagia in hypothesis testing.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.5086
71055738|NCT00094861|141615783|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.46||||0.4976||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants with no assessments were assumed as having grade ≥ 3 dysphagia in hypothesis testing.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.4976
71055739|NCT00094861|141615784|SUPERIORITY_OR_OTHER||Chi-Square Statistic|-2.5325||||0.1115||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants who never received radiotherapy were assumed to have unplanned breaks.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.1115
71055740|NCT00094861|141615785|SUPERIORITY_OR_OTHER||Chi-Square Statistic|3.4812||||0.0621|TWO_SIDED|||||Generalized Cochran-Mantel-Haenszel (CMH) test for mean score difference using modified ridit score. Participants without any ECOG assessment post baseline were assumed to have ECOG status of 5 in the CMH test.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.0621
71055741|NCT00094861|141615786|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.0294||||0.8639||95.0||||Generalized Cochran-Mantel-Haenszel test for general association.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.8639
71055742|NCT00094861|141615787|SUPERIORITY_OR_OTHER||Chi-Square Statistic|3.1414||||0.1996||||||Generalized Cochran-Mantel-Haenszel test for mean score difference using modified ridit score.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.1996
71107351|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8491|TWO_SIDED|95.0|0.2|4.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Low Disease Activity||4.8|0.2|0.8491
71107352|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.97||||0.1278|TWO_SIDED|95.0|0.4|42.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Low Disease Activity||42.5|0.4|0.1278
71107353|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.63|||<|0.0001|TWO_SIDED|95.0|2.1|6.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Low Disease Activity||6.4|2.1|<0.0001
71107354|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43||||0.3027|TWO_SIDED|95.0|0.8|2.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Low Disease Activity||2.7|0.8|0.3027
71107355|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.51|||<|0.0001|TWO_SIDED|95.0|1.5|4.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Low Disease Activity||4.2|1.5|<0.0001
71107356|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.55|||<|0.0001|TWO_SIDED|95.0|2.7|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Low Disease Activity||7.6|2.7|<0.0001
71107357|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.5871|TWO_SIDED|95.0|0.7|2.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Low Disease Activity||2.1|0.7|0.5871
71107358|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.76|||<|0.0001|TWO_SIDED|95.0|2.3|6.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Low Disease Activity||6.1|2.3|<0.0001
71107359|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.52|||<|0.0001|TWO_SIDED|95.0|3.9|11.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Low Disease Activity||11.0|3.9|<0.0001
71107360|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.6716|TWO_SIDED|95.0|0.6|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Low Disease Activity||2.0|0.6|0.6716
71107361|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.4|||<|0.0001|TWO_SIDED|95.0|3.4|8.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Low Disease Activity||8.6|3.4|<0.0001
70933549|NCT01968967|141368246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|95.0|-0.9|1.4||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||1.4|-0.9|
71107362|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.62|||<|0.0001|TWO_SIDED|95.0|2.8|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Low Disease Activity||7.6|2.8|<0.0001
71107363|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.9399|TWO_SIDED|95.0|0.5|1.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Low Disease Activity||1.5|0.5|0.9399
71107364|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.78|||<|0.0001|TWO_SIDED|95.0|3.0|7.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Low Disease Activity||7.7|3.0|<0.0001
71107365|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.25|||<|0.0001|TWO_SIDED|95.0|3.7|10.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Low Disease Activity||10.5|3.7|<0.0001
70933550|NCT01968967|141368246|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-0.1|2.3||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||2.3|-0.1|
71107366|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.6692|TWO_SIDED|95.0|0.6|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Low Disease Activity||1.9|0.6|0.6692
71107367|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.46|||<|0.0001|TWO_SIDED|95.0|3.4|8.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Low Disease Activity||8.7|3.4|<0.0001
71107368|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.74|||<|0.0001|TWO_SIDED|95.0|3.4|9.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80 Low Disease Activity||9.8|3.4|<0.0001
71107369|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.4326|TWO_SIDED|95.0|0.7|2.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80 Low Disease Activity||2.1|0.7|0.4326
71055743|NCT02549027|141615792|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.24|||||TWO_SIDED|90.0|0.12|0.47|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% confidence interval (CI) were computed and back-transformed to obtain the 90% CI interval for LPS treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing LPS was supported if the CI lies below 1 for at least one dose.||0.47|0.12|
70933551|NCT01968967|141368246|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|0.3|2.7||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||2.7|0.3|
71055744|NCT02549027|141615792|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.21|||||TWO_SIDED|90.0|0.1|0.41|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for LPS treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing LPS was supported if the CI lies below 1 for at least one dose.||0.41|0.10|
71055745|NCT02549027|141615792|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.15|||||TWO_SIDED|90.0|0.08|0.3|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for LPS treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing LPS was supported if the CI lies below 1 for at least one dose.||0.30|0.08|
71055746|NCT02549027|141615793|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.05|||||TWO_SIDED|90.0|0.02|0.11|||||Ratio is MK-6096/placebo|Mean log treatment difference of MK-6096 versus placebo (MK-6096 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for LPS treatment ratio.||0.11|0.02|
71055747|NCT02549027|141615796|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.85|||||TWO_SIDED|90.0|0.67|1.07|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for WASO treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing WASO was supported if the CI lies below 1 for at least one dose.||1.07|0.67|
71055748|NCT02549027|141615796|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.68|||||TWO_SIDED|90.0|0.54|0.86|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for WASO treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing WASO was supported if the CI lies below 1 for at least one dose.||0.86|0.54|
71055749|NCT02549027|141615796|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.75|||||TWO_SIDED|90.0|0.6|0.95|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for WASO treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing WASO was supported if the CI lies below 1 for at least one dose.||0.95|0.60|
71055750|NCT02549027|141615797|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.63|||||TWO_SIDED|90.0|0.5|0.79|||||Ratio is MK-6096/placebo|Mean log treatment difference of MK-6096 versus placebo (MK-6096 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for WASO treatment ratio.||0.79|0.50|
71055751|NCT02549027|141615798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.59|||||TWO_SIDED|90.0|-12.01|17.2|||||Difference is MK-1064 - placebo|Analysis used a step-up approach. Mean treatment difference in change from baseline of the lowest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed. If the CI lies completely below 25 milliseconds, testing continued to the next higher MK-1064 dose. The hypothesis that at least one dose of MK-1064 does not produce psychomotor impairment versus placebo as assessed by CRT will be supported if the CI lies below 25 milliseconds for at least one dose.||17.20|-12.01|
71055752|NCT02549027|141615798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.28|||||TWO_SIDED|90.0|-9.33|19.88|||||Difference is MK-1064 - placebo|Analysis used a step-up approach. Mean treatment difference in change from baseline of the lowest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed. If the CI lies completely below 25 milliseconds, testing continued to the next higher MK-1064 dose. The hypothesis that at least one dose of MK-1064 does not produce psychomotor impairment versus placebo as assessed by CRT will be supported if the CI lies below 25 milliseconds for at least one dose.||19.88|-9.33|
71055753|NCT02549027|141615798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.38|||||TWO_SIDED|90.0|-8.23|20.98|||||Difference is MK-1064 - placebo|Analysis used a step-up approach. Mean treatment difference in change from baseline of the lowest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed. If the CI lies completely below 25 milliseconds, testing continued to the next higher MK-1064 dose. The hypothesis that at least one dose of MK-1064 does not produce psychomotor impairment versus placebo as assessed by CRT will be supported if the CI lies below 25 milliseconds for at least one dose.||20.98|-8.23|
71055754|NCT02549027|141615799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.3|||||TWO_SIDED|90.0|-7.1|25.7|||||Difference is MK-6096 - placebo|Mean treatment difference in change from baseline of MK-6096 versus placebo (MK-6096 - placebo) and 90% CI were computed.||25.70|-7.10|
71055755|NCT01421511|141615805|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the early clinical response rates at 48 to 72 Hours after the first infusion of study drug using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10%.|Risk Difference (RD)|2.6|||||TWO_SIDED|95.0|-3.0|8.2|||||Risk difference corresponds to the tedizolid responder rate minus the linezolid responder rate.|||8.2|-3.0|
71107370|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.12|||<|0.0001|TWO_SIDED|95.0|3.2|8.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80 Low Disease Activity||8.2|3.2|<0.0001
70933552|NCT01968967|141368247|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.6|STANDARD_ERROR_OF_MEAN|1.73|||TWO_SIDED|95.0|-20.0|-13.2||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-13.2|-20.0|
70933553|NCT01968967|141368247|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|2.05|||TWO_SIDED|95.0|-20.7|-12.6||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-12.6|-20.7|
70933554|NCT01968967|141368247|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.8|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|-16.5|-9.0||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-9.0|-16.5|
70933555|NCT01968967|141368248|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.4|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|-63.1|-57.6||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-57.6|-63.1|
70933556|NCT01968967|141368249|SUPERIORITY_OR_OTHER||LS Mean Difference|-62.8|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-68.3|-57.3||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-57.3|-68.3|
70933557|NCT01968967|141368250|SUPERIORITY_OR_OTHER||LS Mean Difference|-61.0|STANDARD_ERROR_OF_MEAN|1.27|||TWO_SIDED|95.0|-63.5|-58.5||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-58.5|-63.5|
71022416|NCT01706198|141552785|OTHER||Adjusted Odds Ratio|1.51|||<|0.001|TWO_SIDED|95.0|1.31|1.73||Logistic regression adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender, age and Baseline score.|Regression, Logistic||Adjusted odds ratio of FF/VI versus Usual Care has been presented.|||1.73|1.31|<0.001
71022417|NCT01706198|141552786|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the two-sided 95% confidence interval for the incidence ratio is less than 2.|Incidence ratio|1.4|||||TWO_SIDED|95.0|0.8|2.7|||||Incidence ratio was calculated as percentage of participants who had at least one SAE of pneumonia in the FF/VI group divided by the percentage of participants who had at least one SAE of pneumonia in the Usual Care group.|||2.7|0.8|
71022418|NCT01706198|141552787|OTHER||Hazard Ratio (HR)|1.45||||0.255|TWO_SIDED|95.0|0.77|2.74||Cox proportional hazards model with randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age as covariates.|Cox proportional hazards model||Hazard ratio for FF/VI versus Usual Care has been presented.|||2.74|0.77|0.255
71022419|NCT01473758|141552806|SUPERIORITY_OR_OTHER||LS Mean Difference|1.404|STANDARD_ERROR_OF_MEAN|3.07||0.6491|TWO_SIDED|95.0|-4.731|7.538||The model contains neutrophil count at Baseline and treatment as independent variables, fixed effects.|ANCOVA|||||7.538|-4.731|0.6491
71022420|NCT01473758|141552807|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.412|STANDARD_ERROR_OF_MEAN|2.687||0.8786|TWO_SIDED|95.0|-5.766|4.943||The model contains neutrophil count at Baseline and treatment as independent variables, fixed effects.|ANCOVA|||||4.943|-5.766|0.8786
71022421|NCT01677910|141552864|SUPERIORITY||Mean Difference (Net)|-0.81|||<|0.001|TWO_SIDED|95.0|-1.283|-0.337|||Wilcoxon rank sum||Mean difference is calculated as LX1606-Placebo|Primary analysis used a blocked 2-sample Wilcoxon rank sum statistic stratified by the urinary 5-HIAA stratification at randomization.||-0.337|-1.283|< 0.001
71107371|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.68|||<|0.0001|TWO_SIDED|95.0|2.8|7.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Low Disease Activity||7.8|2.8|<0.0001
71022422|NCT01677910|141552864|SUPERIORITY||Mean Difference (Net)|-0.833|||<|0.001|TWO_SIDED|95.0|-1.292|-0.374|||Wilcoxon rank sum||Mean difference is calculated as LX1606-Placebo|Primary analysis used a blocked 2-sample Wilcoxon rank sum statistic stratified by the urinary 5-HIAA stratification at randomization.||-0.374|-1.292|< 0.001
71022423|NCT04229303|141552871|OTHER||Slope|0.62|||<|0.0001|TWO_SIDED|90.0|0.424|0.821|||General power constant model|||Statistics for Voriconazole AUC0-t||0.821|0.424|<0.0001
71022424|NCT04229303|141552871|OTHER||Slope|1.21||||0.0363|TWO_SIDED|90.0|1.05|1.362|||General power linear model|||Statistics for Voriconazole AUC0-t||1.362|1.050|0.0363
71022425|NCT04229303|141552871|OTHER||Geometric mean difference|13.48|||<|0.0001|TWO_SIDED|90.0|10.096|17.994|||ANOVA|||Statistics for Voriconazole AUC0-t, 40mg vs 5mg||17.994|10.096|<0.0001
71022426|NCT04229303|141552871|OTHER||Slope|1.85|||<|0.0001|TWO_SIDED|90.0|1.728|1.963|||General power constant model|||Statistics for N-oxide Voriconazole AUC0-t||1.963|1.728|<0.0001
71022427|NCT04229303|141552871|OTHER||Slope|0.87||||0.0201|TWO_SIDED|90.0|0.789|0.96|||General power linear model|||Statistics for N-oxide Voriconazole AUC0-t||0.960|0.789|0.0201
71022428|NCT04229303|141552871|OTHER||Geometric mean difference|6.16|||<|0.0001|TWO_SIDED|90.0|5.253|7.217|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-t, 40mg vs 5mg||7.217|5.253|<0.0001
71022429|NCT04229303|141552871|OTHER||Slope|0.81|||<|0.0001|TWO_SIDED|90.0|0.661|0.958|||General power constant model|||Statistics for Voriconazole AUC0-inf||0.958|0.661|<0.0001
71022430|NCT04229303|141552871|OTHER||Slope|1.12||||0.1278|TWO_SIDED|90.0|0.99|1.245|||General power linear model|||Statistics for Voriconazole AUC0-inf||1.245|0.990|0.1278
71022431|NCT04229303|141552871|OTHER||Geometric mean difference|9.43|||<|0.0001|TWO_SIDED|90.0|6.834|13.012|||ANOVA|||Statistics for Voriconazole AUC0-inf, 40mg vs 5mg||13.012|6.834|<0.0001
71022432|NCT04229303|141552871|OTHER||Slope|1.98|||<|0.0001|TWO_SIDED|90.0|1.86|2.106|||General power constant model|||Statistics for N-oxide Voriconazole AUC0-inf||2.106|1.860|<0.0001
71107372|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.6064|TWO_SIDED|95.0|0.6|1.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Low Disease Activity||1.8|0.6|0.6064
71107373|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.68|||<|0.0001|TWO_SIDED|95.0|3.0|7.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Low Disease Activity||7.4|3.0|<0.0001
71107374|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.4626|TWO_SIDED|95.0|0.5|3.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Remission||3.3|0.5|0.4626
71107375|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.2886|TWO_SIDED|95.0|0.6|3.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Remission||3.3|0.6|0.2886
71107376|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.7779|TWO_SIDED|95.0|0.4|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Remission||1.9|0.4|0.7779
71022433|NCT04229303|141552871|OTHER||Slope|0.79||||0.0082|TWO_SIDED|90.0|0.67|0.912|||General power linear model|||Statistics for N-oxide Voriconazole AUC0-inf||0.912|0.670|0.0082
71022434|NCT04229303|141552871|OTHER||Geometric mean difference|5.86|||<|0.0001|TWO_SIDED|90.0|4.627|7.421|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-inf, 40mg vs 5mg||7.421|4.627|<0.0001
71022435|NCT04229303|141552872|OTHER||Slope|0.12||||0.2575|TWO_SIDED|90.0|-0.06|0.308|||General power constant model|||Statistics for Voriconazole Cmax||0.308|-0.060|0.2575
71022436|NCT04229303|141552872|OTHER||Slope|1.17||||0.0491|TWO_SIDED|90.0|1.03|1.316|||General power linear model|||Statistics for Voriconazole Cmax||1.316|1.030|0.0491
71022437|NCT04229303|141552872|OTHER||Geometric mean difference|11.17|||<|0.0001|TWO_SIDED|90.0|8.435|14.803|||ANOVA|||Statistics for Voriconazole Cmax, 40mg vs 5mg||14.803|8.435|<0.0001
71022438|NCT04229303|141552872|OTHER||Slope|1.25|||<|0.0001|TWO_SIDED|90.0|1.135|1.363|||General power constant model|||Statistics for N-oxide Voriconazole Cmax||1.363|1.135|<0.0001
71022439|NCT04229303|141552872|OTHER||Slope|0.74||||0.0003|TWO_SIDED|90.0|0.634|0.843|||General power linear model|||Statistics for N-oxide Voriconazole Cmax||0.843|0.634|0.0003
71022440|NCT04229303|141552872|OTHER||Geometric mean difference|4.97|||<|0.0001|TWO_SIDED|90.0|3.946|6.254|||ANOVA|||Statistics for N-oxide Voriconazole Cmax, 40mg vs 5mg||6.254|3.946|<0.0001
71022441|NCT04229303|141552879|OTHER||Slope|2.0||||0.0004|TWO_SIDED|90.0|1.528|2.617|||ANOVA|||Statistics for Voriconazole AUC0-t Day 1||2.617|1.528|0.0004
71022442|NCT04229303|141552879|OTHER||Slope|4.73|||<|0.0001|TWO_SIDED|90.0|3.612|6.187|||ANOVA|||Statistics for Voriconazole AUC0-t Day 1||6.187|3.612|<0.0001
71022443|NCT04229303|141552879|OTHER||Slope|2.81|||<|0.0001|TWO_SIDED|90.0|2.017|3.925|||ANOVA|||Statistics for Voriconazole AUC0-t day 10||3.925|2.017|<0.0001
71022444|NCT04229303|141552879|OTHER||Slope|5.28|||<|0.0001|TWO_SIDED|90.0|3.783|7.361|||ANOVA|||Statistics for Voriconazole AUC0-t Day 10||7.361|3.783|<0.0001
71022445|NCT04229303|141552879|OTHER||Slope|1.97|||<|0.0001|TWO_SIDED|90.0|1.615|2.396|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-t Day 1||2.396|1.615|<0.0001
71022446|NCT04229303|141552879|OTHER||Slope|5.09|||<|0.0001|TWO_SIDED|90.0|4.178|6.196|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-t Day 1||6.196|4.178|<0.0001
71022447|NCT04229303|141552879|OTHER||Slope|2.45||||0.0002|TWO_SIDED|90.0|1.791|3.349|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-t Day 10||3.349|1.791|0.0002
71022448|NCT04229303|141552879|OTHER||Slope|4.6|||<|0.0001|TWO_SIDED|90.0|3.365|6.294|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-t Day 10||6.294|3.365|<0.0001
71022449|NCT04229303|141552879|OTHER||Slope|1.99||||0.0005|TWO_SIDED|90.0|1.524|2.602|||ANOVA|||Statistics for Voriconazole AUC0-inf Day 1||2.602|1.524|0.0005
71022450|NCT04229303|141552879|OTHER||Slope|4.58|||<|0.0001|TWO_SIDED|90.0|3.505|5.984|||ANOVA|||Statistics for Voriconazole AUC0-inf Day 1||5.984|3.505|<0.0001
71022451|NCT04229303|141552879|OTHER||Slope|2.65||||0.0003|TWO_SIDED|90.0|1.851|3.781|||ANOVA|||Statistics for Voriconazole AUC0-inf Day 10||3.781|1.851|0.0003
71022452|NCT04229303|141552879|OTHER||Slope|5.04|||<|0.0001|TWO_SIDED|90.0|3.587|7.088|||ANOVA|||Statistics for Voriconazole AUC0-inf Day 10||7.088|3.587|<0.0001
71022453|NCT04229303|141552879|OTHER||Slope|1.93|||<|0.0001|TWO_SIDED|90.0|1.569|2.384|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-inf Day 1||2.384|1.569|<0.0001
71022454|NCT04229303|141552879|OTHER||Slope|4.56|||<|0.0001|TWO_SIDED|90.0|3.608|5.759|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-inf Day 1||5.759|3.608|<0.0001
71022455|NCT04229303|141552879|OTHER||Slope|2.4||||0.0007|TWO_SIDED|90.0|1.694|3.402|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-inf Day 10||3.402|1.694|0.0007
71022456|NCT04229303|141552879|OTHER||Slope|4.22|||<|0.0001|TWO_SIDED|90.0|2.975|5.974|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-inf Day 10||5.974|2.975|<0.0001
71022457|NCT04229303|141552880|OTHER||Slope|2.03||||0.0003|TWO_SIDED|90.0|1.562|2.65|||ANOVA|||Statistics for Voriconazole Cmax Day 1||2.650|1.562|0.0003
71022458|NCT04229303|141552880|OTHER||Slope|4.87|||<|0.0001|TWO_SIDED|90.0|3.74|6.345|||ANOVA|||Statistics for Voriconazole Cmax Day 1||6.345|3.740|<0.0001
71022459|NCT04229303|141552880|OTHER||Slope|2.67|||<|0.0001|TWO_SIDED|90.0|2.081|3.429|||ANOVA|||Statistics for Voriconazole Cmax Day 10||3.429|2.081|<0.0001
71022460|NCT04229303|141552880|OTHER||Slope|5.97|||<|0.0001|TWO_SIDED|90.0|4.647|7.658|||ANOVA|||Statistics for Voriconazole Cmax Day 10||7.658|4.647|<0.0001
71022461|NCT04229303|141552880|OTHER||Slope|2.02|||<|0.0001|TWO_SIDED|90.0|1.688|2.406|||ANOVA|||Statistics for N-oxide Voriconazole Cmax Day 1||2.406|1.688|<0.0001
71022462|NCT04229303|141552880|OTHER||Slope|4.73|||<|0.0001|TWO_SIDED|90.0|3.964|5.65|||ANOVA|||Statistics for N-oxide Voriconazole Cmax Day 1||5.650|3.964|<0.0001
71022463|NCT04229303|141552880|OTHER||Slope|2.12|||<|0.0001|TWO_SIDED|90.0|1.655|2.711|||ANOVA|||Statistics for N-oxide Voriconazole Cmax Day 10||2.711|1.655|<0.0001
71022464|NCT04229303|141552880|OTHER||Slope|4.01|||<|0.0001|TWO_SIDED|90.0|3.135|5.135|||ANOVA|||Statistics for N-oxide Voriconazole Cmax day 10||5.135|3.135|<0.0001
71022465|NCT04229303|141552901|OTHER||Geometric mean ratio|0.13|||||TWO_SIDED|90.0|0.107|0.146||||||Part 3 - ZP-059 20mg: Oral Voriconazole (200mg VFEND)||0.146|0.107|
70851436|NCT00312195|141190770|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.79|STANDARD_ERROR_OF_MEAN|0.2544||0.0217|TWO_SIDED|95.0|1.09|2.95||P value is from a logistic regression analysis with terms for treatment effect, country and pain site (hip, knee, back and other).|Regression, Logistic||Primary variable was defined as: ratio of the probability of having ineffective treatment divided by the probability of having effective treatment.|H0: the odds of ineffective treatment is the same for subjects receiving placebo as for those receiving BTDS versus the alternative H1: the odds of ineffective treatment is different for subjects receiving placebo from those receiving BTDS.||2.95|1.09|.0217
70851437|NCT01015638|141190783|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Kruskal-Wallis|||||||>0.05
71055756|NCT01421511|141615806|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the programmatic clinical response at the EOT visit using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-6.1|4.1||Hierarchical testing procedure of Westfall and Krishen used to control for inflation of the overall type I error rate. If NI is declared for the primary, NI will be tested for the secondary outcomes in this order: Secondary Outcomes Measures 2 to 5.|||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|||4.1|-6.1|
70851438|NCT01015638|141190784|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Dunn's Multiple Comparisons Test|||||||>0.05
71055757|NCT01421511|141615807|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the Investigator's assessment of clinical response at the EOT Visit using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-4.1|||||TWO_SIDED|95.0|-8.8|0.3|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|||0.3|-8.8|
71055758|NCT01421511|141615808|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the clinical success rate based on the Investigator's assessment of clinical response at the PTE Visit using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-4.8|5.3|||||Risk difference corresponds to the tedizolid clinical success rate minus the linezolid clinical success rate.|||5.3|-4.8|
71107377|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.94|||<|0.0001|TWO_SIDED|95.0|1.8|4.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Remission||4.7|1.8|<0.0001
71107378|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.2091|TWO_SIDED|95.0|0.8|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Remission||2.0|0.8|0.2091
70851439|NCT01015638|141190785|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Kruskal-Wallis|||||||>0.05
70851440|NCT01015638|141190786|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Tukey-Kramer Multiple Comparisons Test|||||||> 0.05
70851441|NCT05871450|141190890|SUPERIORITY|||||||0.05|||||||Regression, Linear|||||||0.05
71107379|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.31|||<|0.0001|TWO_SIDED|95.0|1.5|3.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Remission||3.6|1.5|<0.0001
71107380|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.33|||<|0.0001|TWO_SIDED|95.0|2.1|5.2||p-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Remission||5.2|2.1|<0.0001
71107381|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.5351|TWO_SIDED|95.0|0.7|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Remission||1.7|0.7|0.5351
71022466|NCT04229303|141552901|OTHER||Geometric mean ratio|2.1|||||TWO_SIDED|90.0|1.545|2.853||||||ZP-059 20mg: Part 3 / Part 1||2.853|1.545|
71107382|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.12|||<|0.0001|TWO_SIDED|95.0|2.0|4.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Remission||4.8|2.0|<0.0001
71107383|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.09|||<|0.0001|TWO_SIDED|95.0|2.6|6.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Remission||6.5|2.6|<0.0001
71022467|NCT04229303|141552901|OTHER||Geometric mean ratio|2.63|||||TWO_SIDED|90.0|1.953|3.544||||||ZP-059 20mg: Part 3 / Part 2 Day 1||3.544|1.953|
71107384|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.4574|TWO_SIDED|95.0|0.5|1.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Remission||1.3|0.5|0.4574
71022468|NCT04229303|141552901|OTHER||Geometric mean ratio|1.87|||||TWO_SIDED|90.0|1.386|2.52||||||ZP-059 20mg: Part 3 / Part 2 Day 10||2.520|1.386|
71022469|NCT04229303|141552902|OTHER||Geometric mean ratio|0.07|||||TWO_SIDED|90.0|0.059|0.075||||||Part 3 ZP-059 20mg: Oral Voriconazole (200mg VFEND®)||0.075|0.059|
71022470|NCT04229303|141552902|OTHER||Geometric mean ratio|1.27|||||TWO_SIDED|90.0|0.85|1.891||||||ZP-059 20mg: Part 3 / Part 1||1.891|0.850|
71022471|NCT04229303|141552902|OTHER||Geometric mean ratio|2.63|||||TWO_SIDED|90.0|1.953|3.544||||||ZP-059 20mg: Part 3 / Part 2 Day 1||3.544|1.953|
71022472|NCT04229303|141552902|OTHER||Geometric mean ratio|1.87|||||TWO_SIDED|90.0|1.386|2.52||||||ZP-059 20mg: Part 3 / Part 2 Day 10||2.520|1.386|
71022473|NCT02763579|141552903|SUPERIORITY||Stratified Hazard Ratio|0.77||||0.017|TWO_SIDED|95.0|0.62|0.96|||Log Rank|||||0.96|0.62|0.0170
71022474|NCT02763579|141552904|SUPERIORITY||Stratified Hazard Ratio|0.7||||0.0069|TWO_SIDED|95.0|0.54|0.91|||Log Rank|||||0.91|0.54|0.0069
71022475|NCT02763579|141552905|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.55|1.37||||||||1.37|0.55|
70933558|NCT01968967|141368251|SUPERIORITY_OR_OTHER||LS Mean Difference|-63.7|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|95.0|-66.6|-60.9||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-60.9|-66.6|
71022476|NCT02763579|141552906|SUPERIORITY||Hazard Ratio (HR)|0.715||||0.0063|TWO_SIDED|95.0|0.562|0.911|||Log Rank|||||0.911|0.562|0.0063
71022477|NCT02763579|141552907|SUPERIORITY||Difference in Event Free Rate|8.47||||0.0593|TWO_SIDED|95.0|-0.33|17.27|||Z-test|||PFS Rate at 6 months||17.27|-0.33|0.0593
71022478|NCT02763579|141552907|SUPERIORITY||Difference in Event Free Rate|7.27||||0.0133|TWO_SIDED|95.0|1.52|13.02|||Z-test|||PFS Rate at 1 year||13.02|1.52|0.0133
71022479|NCT02763579|141552908|SUPERIORITY||Difference in Event Free Rate|13.46||||0.0095|TWO_SIDED|95.0|3.29|23.64|||Z-test|||OS Rate at 1 year||23.64|3.29|0.0095
71022480|NCT02763579|141552909|SUPERIORITY|Stratified analysis. Stratification factors: Sex (male vs female) and ECOG (0 vs 1).|Hazard Ratio (HR)|1.221||||0.3604|TWO_SIDED|95.0|0.795|1.874|||Log Rank|||Cough||1.874|0.795|0.3604
71022481|NCT02763579|141552909|SUPERIORITY|Stratified analysis. Stratification factors: Sex (male vs female) and ECOG (0 vs 1).|Hazard Ratio (HR)|1.058||||0.7712|TWO_SIDED|95.0|0.722|1.553|||Log Rank|||Pain in Chest||1.553|0.722|0.7712
71022482|NCT02763579|141552909|SUPERIORITY|Stratified analysis. Stratification factors: Sex (male vs female) and ECOG (0 vs 1).|Hazard Ratio (HR)|1.077||||0.6922|TWO_SIDED|95.0|0.747|1.552|||Log Rank|||Pain in Arm or Shoulder||1.552|0.747|0.6922
71022483|NCT02763579|141552909|SUPERIORITY|Stratified analysis. Stratification factors: Sex (male vs female) and ECOG (0 vs 1).|Hazard Ratio (HR)|0.748||||0.065|TWO_SIDED|95.0|0.549|1.019|||Log Rank|||Dyspnea||1.019|0.549|0.0650
71022484|NCT00606684|141552916|SUPERIORITY_OR_OTHER||Least squares mean difference|0.092|||<|0.001|TWO_SIDED|95.0|0.039|0.144|||ANCOVA|||||0.144|0.039|<0.001
71022485|NCT00606684|141552916|SUPERIORITY_OR_OTHER||Least squares mean difference|0.098|||<|0.001|TWO_SIDED|95.0|0.046|0.15|||ANCOVA|||||0.150|0.046|<0.001
71022486|NCT00606684|141552916|SUPERIORITY_OR_OTHER||Least squares mean difference|0.11|||<|0.001|TWO_SIDED|95.0|0.057|0.162|||ANCOVA|||||0.162|0.057|<0.001
71022487|NCT00606684|141552916|SUPERIORITY_OR_OTHER||Least squares mean difference|0.137|||<|0.001|TWO_SIDED|95.0|0.085|0.19|||ANCOVA|||||0.190|0.085|<0.001
71022488|NCT00606684|141552916|SUPERIORITY_OR_OTHER||Least squares mean difference|0.165|||<|0.001|TWO_SIDED|95.0|0.112|0.217|||ANCOVA|||||0.217|0.112|<0.001
71022489|NCT02144259|141552920|SUPERIORITY_OR_OTHER||||||<|0.05|||||||GEE|||Because the expected amount of postpartum weight loss in non-breastfeeding women is not documented in the literature, we chose a sample size that would enable us to detect a one standard deviation difference in weight loss between the 3 groups at the primary 6 month endpoint. We used generalized estimating equations (GEEs) to test differences among all 3 groups over all the study periods.||||<0.05
71022490|NCT02144259|141552922|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
71022491|NCT04169282|141552943|SUPERIORITY|||||||0.108|||||||t-test, 1 sided|paired t-test for normally distributed and transformed data or Wilcoxon's Signed Rank test for non-parametric paired data||||||0.108
71022492|NCT04169282|141552944|SUPERIORITY|||||||0.003|||||||t-test, 1 sided|paired t-test for normally distributed and transformed data or Wilcoxon's Signed Rank test for non-parametric paired data||||||0.003
71022493|NCT04169282|141552945|SUPERIORITY|||||||0.025|||||||t-test, 1 sided|paired t-test for normally distributed and transformed data or Wilcoxon's Signed Rank test for non-parametric paired data||||||0.025
71022494|NCT00621686|141552952|SUPERIORITY_OR_OTHER|||||||0.069|||||||Log Rank|||||||0.069
71022495|NCT01170364|141552967|SUPERIORITY||||||<|0.004|||||||paired sample t-test, two tailed|||||||<0.004
71022496|NCT01381900|141552968|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|95.0|-0.644|-0.367|||ANCOVA|||||-0.367|-0.644|<0.001
71022497|NCT01381900|141552968|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|95.0|-0.731|-0.453|||ANCOVA|||||-0.453|-0.731|<0.001
71022498|NCT01381900|141552969|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.173|<|0.001|TWO_SIDED|95.0|-1.375|-0.694|||ANCOVA|||||-0.694|-1.375|<0.001
71022499|NCT01381900|141552969|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.43|STANDARD_ERROR_OF_MEAN|0.173|<|0.001|TWO_SIDED|95.0|-1.769|-1.089|||ANCOVA|||||-1.089|-1.769|<0.001
71022500|NCT01381900|141552970|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.7|-1.6|||ANCOVA|||||-1.6|-2.7|<0.001
71022501|NCT01381900|141552970|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.9|-1.8|||ANCOVA|||||-1.8|-2.9|<0.001
71022502|NCT01381900|141552971|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.26|||||TWO_SIDED|95.0|2.09|5.09|||Regression, Logistic|||||5.09|2.09|
71022503|NCT01381900|141552971|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.99|||||TWO_SIDED|95.0|2.55|6.27|||Regression, Logistic|||||6.27|2.55|
71022504|NCT01381900|141552972|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.55|||||TWO_SIDED|95.0|1.45|4.48|||Regression, Logistic|||||4.48|1.45|
71022505|NCT01381900|141552972|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.29|||||TWO_SIDED|95.0|1.88|5.75|||Regression, Logistic|||||5.75|1.88|
71055759|NCT01421511|141615809|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the clinical success rate based on the Investigator's assessment of clinical response at the PTE Visit using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-3.7|||||TWO_SIDED|95.0|-7.7|0.2|||||Risk difference corresponds to the tedizolid clinical success rate minus the linezolid clinical success rate.|||0.2|-7.7|
71055760|NCT01421511|141615810|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.2|||||TWO_SIDED|95.0|-3.3|5.6|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the Investigator's assessment of clinical response at the 48-72 Hour Visit using the method of Miettinen and Nurminen without stratification.||5.6|-3.3|
71022506|NCT03341273|141552975|NON_INFERIORITY|The non-inferiority margin is 12.5%. Non-inferiority of placebo is concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical improvement is greater than -12.5%.|Risk Difference (RD)|-6.0|||||TWO_SIDED|95.0|-15.0|2.0||The null hypothesis was evaluated using a non-inferiority test and non-inferiority of placebo was concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical improvement was greater than -12.5%.|||Multiple imputation with a linear model to impute missing clinical values of improvement. The study day that D5V occurred on was included as a covariate in the final model and the estimates for risk difference assume that study day of D5V is 5.|Null Hypothesis: Proportion in placebo - Proportion in azithromycin = -12.5%||2|-15|
71022507|NCT03341273|141552976|NON_INFERIORITY|The non-inferiority margin is 12.5%. Non-inferiority of placebo is concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical improvement is greater than -12.5%.|Risk Difference (RD)|-4.0|||||TWO_SIDED|95.0|-12.0|3.0||The null hypothesis was evaluated using a non-inferiority test and non-inferiority of placebo was concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical improvement was greater than -12.5%.|||Multiple imputation with a linear model to impute missing clinical values of improvement. The study day that D11V occurred on was included as a covariate in the final model and the estimates for risk difference assume that study day of D11V is 11.|Null Hypothesis: Proportion in placebo - Proportion in azithromycin = -12.5%||3|-12|
71022508|NCT03341273|141552977|NON_INFERIORITY|The non-inferiority margin is 12.5%. Non-inferiority of placebo is concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical improvement is greater than -12.5%.|Risk Difference (RD)|-7.0|||||TWO_SIDED|95.0|-13.0|0.0||The null hypothesis was evaluated using a non-inferiority test and non-inferiority of placebo was concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical improvement was greater than -12.5%.|||Multiple imputation with a linear model to impute missing clinical values of improvement. The study day that D11V occurred on was included as a covariate in the final model and the estimates for risk difference assume that study day of D28V is 28.|Null Hypothesis: Proportion in placebo - Proportion in azithromycin = -12.5%||0|-13|
71022509|NCT03341273|141552978|SUPERIORITY|DOOR is a composite endpoint created using clinical outcomes from Day 1 through Day 5 Visit. It is based on adequate clinical improvement at Day 5 Visit and solicited events from Day 1 through Day 5 Visit.|Pr(Higher DOOR in Placebo at Day 5 Visit|0.63|||<|0.001|TWO_SIDED|95.0|0.57|0.68||Missing DOOR values at Day 5 Visit were first imputed using linear regression using baseline covariates and available DOOR components as covariates.|Wilcoxon (Mann-Whitney)|The Mann-Whitney test was run on the multiple imputed datasets to generate estimates of DOOR probability and p-value||Null: The sum of the probability that a participant assigned to placebo will have a higher DOOR at Day 5 visit than if assigned to the Azithromycin plus one-half the probability of equal DOORs at Day 5 Visit is 50% (i.e., no difference in DOOR at Day 5 Visit).||0.68|0.57|<0.001
71022510|NCT01717456|141553009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|STANDARD_DEVIATION|6.72||0.05|TWO_SIDED|95.0||||No adjustment for multiple comparisons.|t-test, 2 sided|||||||.05
71022511|NCT03751020|141553043|SUPERIORITY||Mean Difference (Net)|-6.34|||<|0.01|TWO_SIDED|95.0|-11.03|-1.64|||Mixed Models Analysis|||The primary comparison was between EW and control to test the interaction between treatment and time.||-1.64|-11.03|<0.01
71022512|NCT03751020|141553044|SUPERIORITY||Mean Difference (Net)|-0.33||||0.03|TWO_SIDED|95.0|-0.62|-0.03|||Mixed Models Analysis|||The primary comparison was between EW and control to test the interaction between treatment and time.||-0.03|-0.62|0.03
71022513|NCT03751020|141553045|SUPERIORITY||Mean Difference (Net)|-4.03||||0.07|TWO_SIDED|95.0|-8.55|0.47|||Mixed Models Analysis|||The primary comparison was between EW and control to test the interaction between treatment and time.||0.47|-8.55|0.07
71022514|NCT03751020|141553046|SUPERIORITY||Mean Difference (Net)|1.12||||0.73|TWO_SIDED|95.0|-6.48|8.77|||Mixed Models Analysis|||The primary comparison was between EW and control to test the interaction between treatment and time.||8.77|-6.48|0.73
71022515|NCT03751020|141553047|SUPERIORITY||Mean Difference (Net)|-1.28||||0.1|TWO_SIDED|95.0|-2.8|0.24|||Mixed Models Analysis|||The primary comparison was between EW and control to test the interaction between treatment and time.||0.24|-2.80|0.10
71022516|NCT03751020|141553048|SUPERIORITY||Mean Difference (Net)|0.09||||0.76|TWO_SIDED|95.0|-1.19|1.57|||Mixed Models Analysis|||The primary comparison was between EW and control to test the interaction between treatment and time.||1.57|-1.19|0.76
71022517|NCT00033631|141553073|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.83|1.2||Two-sided test, significance level = 0.05|Log Rank||Reference level = 70.2 Gy arm|The original target sample size was 1520 patients with a requirement of 715 deaths to test the hypothesis of overall survival (OS) efficacy of the 79.2 Gy arm. The trial was designed to detect a hazard ratio (HR) of 1.30 (standard/high-dose) with 90% statistical power at a one-sided significance level of 0.025.||1.2|0.83|0.98
71022518|NCT00033631|141553074|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.5|0.7||Two-sided significance level = 0.05|Gray's test|Reference arm is 70.2 Gy arm||||0.70|0.50|<0.0001
71022519|NCT00033631|141553075|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.66||||0.14|TWO_SIDED|95.0|0.38|1.15|||Gray's test|Two-sided significance level = 0.05|Reference level is 70.2 Gy arm|||1.15|0.38|0.14
71022520|NCT00033631|141553076|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.41||||0.0001|TWO_SIDED|95.0|0.25|0.66|||Gray's test|Two-sided significance level = 0.05|Reference level = 70.2 Gy arm|||0.66|0.25|0.0001
71022521|NCT00033631|141553077|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.65||||0.051|TWO_SIDED|95.0|0.42|1.01||Two-sided significance level = 0.05|Gray's test||Reference level is the 70.2 Gy level|||1.01|0.42|0.051
71022522|NCT00033631|141553078|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||Two-sided significance level = 0.05|Chi-squared|||||||0.29
71022523|NCT00033631|141553079|SUPERIORITY|||||||0.0513|||||||Chi-squared|Two-sided significance level = 0.05||With an expected percentage of erectile disfunction (ED) at 12 months of 29%, a two-sided significance level of 0.05, and 688 patients per arm provides 90% statistical power to detect a reduction in ED to 19%. This calculation assumes 26% ED at baseline and 80% compliance at 12 months. Only participants with baseline ED are analyzed.||||0.0513
71022524|NCT00033631|141553080|SUPERIORITY|||||||0.59|||||||Chi-squared|Two-sided significance level = 0.05||||||0.59
71022525|NCT00528879|141553084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.1014||0.0002||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA|||||||0.0002
71055761|NCT01421511|141615811|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.9|||||TWO_SIDED|95.0|-3.2|4.9|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the Investigator's assessment of clinical response at the Day 7 Visit using the method of Miettinen and Nurminen without stratification.||4.9|-3.2|
71055762|NCT01775189|141615861|SUPERIORITY_OR_OTHER||Least Squares (LS) mean Difference|9.5||||0.0001|TWO_SIDED|95.0|4.8|14.2||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||14.2|4.8|0.0001
71055763|NCT01775189|141615861|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.3|||<|0.0001|TWO_SIDED|95.0|-37.0|-27.6||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-27.6|-37.0|<0.0001
71055764|NCT01775189|141615861|SUPERIORITY_OR_OTHER||LS Mean Difference|9.1||||0.0002|TWO_SIDED|95.0|4.5|13.8||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.8|4.5|0.0002
71055765|NCT01775189|141615861|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.8806|TWO_SIDED|95.0|-5.0|4.3||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.3|-5.0|0.8806
71055766|NCT01775189|141615861|SUPERIORITY_OR_OTHER||LS Mean Difference|41.4|||<|0.0001|TWO_SIDED|95.0|36.8|46.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||46.1|36.8|<0.0001
71055767|NCT01775189|141615861|SUPERIORITY_OR_OTHER||LS Mean Difference|41.8|||<|0.0001|TWO_SIDED|95.0|37.1|46.4||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||46.4|37.1|<0.0001
71055768|NCT01775189|141615862|SUPERIORITY_OR_OTHER||LS Mean Difference|6.6||||0.2176|TWO_SIDED|95.0|-4.0|17.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||17.1|-4.0|0.2176
71055769|NCT01775189|141615862|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.6|||<|0.0001|TWO_SIDED|95.0|-65.1|-44.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-44.1|-65.1|<0.0001
71055770|NCT01775189|141615862|SUPERIORITY_OR_OTHER||LS Mean Difference|5.0||||0.3502|TWO_SIDED|95.0|-5.6|15.5||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||15.5|-5.6|0.3502
71107385|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.04|||<|0.0001|TWO_SIDED|95.0|3.2|8.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Remission||8.0|3.2|<0.0001
71107386|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.19|||<|0.0001|TWO_SIDED|95.0|2.7|6.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Remission||6.6|2.7|<0.0001
71107387|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.5229|TWO_SIDED|95.0|0.7|1.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Remission||1.8|0.7|0.5229
71107388|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.84|||<|0.0001|TWO_SIDED|95.0|2.5|6.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Remission||6.0|2.5|<0.0001
71107389|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.36|||<|0.0001|TWO_SIDED|95.0|3.3|8.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Remission||8.6|3.3|<0.0001
71055771|NCT01775189|141615862|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6||||0.7624|TWO_SIDED|95.0|-12.1|8.9||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||8.9|-12.1|0.7624
71107390|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.6464|TWO_SIDED|95.0|0.7|1.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Remission||1.8|0.7|0.6464
70933559|NCT01968967|141368252|SUPERIORITY_OR_OTHER||LS Mean Difference|-66.4|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|95.0|-69.3|-63.6||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-63.6|-69.3|
70933560|NCT01968967|141368253|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.8|STANDARD_ERROR_OF_MEAN|0.97|||TWO_SIDED|95.0|-47.7|-43.9||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-43.9|-47.7|
70933561|NCT01968967|141368254|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.6|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-11.8|-9.3||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-9.3|-11.8|
70933562|NCT01968967|141368255|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|2.1|3.3||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||3.3|2.1|
70933563|NCT01968967|141368256|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-1.6|-1.5||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-1.5|-1.6|
70933564|NCT01968967|141368256|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-1.5|-1.3||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-1.3|-1.5|
70933565|NCT01968967|141368256|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-1.2|-1.0||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-1.0|-1.2|
70933566|NCT01968967|141368257|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.3|-0.3||||||Week 12: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.3|-0.3|
70933567|NCT01968967|141368257|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.3|-0.3||||||Week 24: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.3|-0.3|
70933568|NCT01968967|141368257|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.3|-0.2||||||Week 52: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.2|-0.3|
70933569|NCT01968967|141368258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|27.0|||||TWO_SIDED|95.0|19.21|38.02||||||Week 12: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||38.02|19.21|
71055772|NCT01775189|141615862|SUPERIORITY_OR_OTHER||LS Mean Difference|59.6|||<|0.0001|TWO_SIDED|95.0|49.0|70.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||70.1|49.0|<0.0001
70933570|NCT01968967|141368258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.9|||||TWO_SIDED|95.0|9.84|16.86||||||Week 24: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||16.86|9.84|
71055773|NCT01775189|141615862|SUPERIORITY_OR_OTHER||LS Mean Difference|61.2|||<|0.0001|TWO_SIDED|95.0|50.6|71.7||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||71.7|50.6|<0.0001
71055774|NCT01775189|141615863|SUPERIORITY_OR_OTHER||LS Mean Difference|24.5|||<|0.0001|TWO_SIDED|95.0|13.8|35.3||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||35.3|13.8|<0.0001
71055775|NCT01775189|141615863|SUPERIORITY_OR_OTHER||LS Mean Difference|-61.7|||<|0.0001|TWO_SIDED|95.0|-72.6|-50.9||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-50.9|-72.6|<0.0001
70933571|NCT01968967|141368258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.3|||||TWO_SIDED|95.0|4.99|8.06||||||Week 52: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||8.06|4.99|
71055776|NCT01775189|141615863|SUPERIORITY_OR_OTHER||LS Mean Difference|18.2||||0.0012|TWO_SIDED|95.0|7.4|29.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||29.1|7.4|0.0012
71055777|NCT01775189|141615863|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.3||||0.2507|TWO_SIDED|95.0|-17.2|4.5||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.5|-17.2|0.2507
71055778|NCT01775189|141615863|SUPERIORITY_OR_OTHER||LS Mean Difference|79.9|||<|0.0001|TWO_SIDED|95.0|69.2|90.7||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||90.7|69.2|<0.0001
71055779|NCT01775189|141615863|SUPERIORITY_OR_OTHER||LS Mean Difference|86.3|||<|0.0001|TWO_SIDED|95.0|75.4|97.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||97.1|75.4|<0.0001
71055780|NCT01775189|141615864|SUPERIORITY_OR_OTHER||LS Mean Difference|26.9||||0.0015|TWO_SIDED|95.0|10.6|43.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||43.1|10.6|0.0015
71055781|NCT01775189|141615864|SUPERIORITY_OR_OTHER||LS Mean Difference|-109.3|||<|0.0001|TWO_SIDED|95.0|-125.7|-93.0||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-93.0|-125.7|<0.0001
71055782|NCT01775189|141615864|SUPERIORITY_OR_OTHER||LS Mean Difference|21.4||||0.0109|TWO_SIDED|95.0|5.1|37.8||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||37.8|5.1|0.0109
71055783|NCT01775189|141615864|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.4||||0.5117|TWO_SIDED|95.0|-21.8|10.9||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||10.9|-21.8|0.5117
71055784|NCT01775189|141615864|SUPERIORITY_OR_OTHER||LS Mean Difference|130.8|||<|0.0001|TWO_SIDED|95.0|114.5|147.0||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||147.0|114.5|<0.0001
71055785|NCT01775189|141615864|SUPERIORITY_OR_OTHER||LS Mean Difference|136.2|||<|0.0001|TWO_SIDED|95.0|119.8|152.5||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||152.5|119.8|<0.0001
71055786|NCT00741286|141615931|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||A linear mixed model for a repeated measures covariance pattern model with unstructured covariances within subjects was used. Two fixed effects were included: 1 between-subjects treatment effect (group: cilostazol, control) and 1 within-subject time effect (time: baseline, 14 days, 90 days). A possible difference in treatment across 14- and 90-day follow-up was analyzed by time x treatment interactions.||||<0.05
71107391|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.79|||<|0.0001|TWO_SIDED|95.0|3.0|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Remission||7.6|3.0|<0.0001
71055787|NCT00741286|141615931|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||To determine between-group differences of changes in the PIs at 14 and 90 days from the baseline study.||||<0.05
71055788|NCT00741286|141615932|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
71055789|NCT02597127|141615945|SUPERIORITY|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 200 mg (Single-Dose) Inclisiran group versus Placebo (Single-Dose).|t-test, 1 sided|||||||<0.0001
71107392|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.96|||<|0.0001|TWO_SIDED|95.0|3.1|7.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80 Remission||7.9|3.1|<0.0001
71107393|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13||||0.5499|TWO_SIDED|95.0|0.7|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80 Remission||1.7|0.7|0.5499
71107394|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.11|||<|0.0001|TWO_SIDED|95.0|2.6|6.4|||Cochran-Mantel-Haenszel|||Week 80 Remission||6.4|2.6|<0.0001
71107395|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.41|||<|0.0001|TWO_SIDED|95.0|2.8|7.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Remission||7.0|2.8|<0.0001
70933572|NCT01968967|141368259|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|86.5|||||TWO_SIDED|95.0|61.74|121.25||||||Week 12: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||121.25|61.74|
70933573|NCT01968967|141368259|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|35.9|||||TWO_SIDED|95.0|26.83|47.96||||||Week 24: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||47.96|26.83|
71022526|NCT00528879|141553084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.1016|<|0.0001||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA|||||||<0.0001
71022527|NCT00528879|141553084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.1021|<|0.0001||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA|||||||<0.0001
71022528|NCT00528879|141553085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.8|STANDARD_ERROR_OF_MEAN|3.774|<|0.0019||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0019
71022529|NCT00528879|141553085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.5|STANDARD_ERROR_OF_MEAN|3.781|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
71022530|NCT00528879|141553085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.5|STANDARD_ERROR_OF_MEAN|3.819|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
71022531|NCT00528879|141553086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32|STANDARD_ERROR_OF_MEAN|0.3344|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
71022532|NCT00528879|141553086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.16|STANDARD_ERROR_OF_MEAN|0.3344|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
71022533|NCT00528879|141553086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.97|STANDARD_ERROR_OF_MEAN|0.3365|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
71022534|NCT00528879|141553087|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|7.1||||0.1775||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|Modified logistic regression|||||||0.1775
71022535|NCT00528879|141553087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7||||0.0275||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|Modified logistic regression|||||||0.0275
71055790|NCT02597127|141615945|SUPERIORITY|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 300 mg (Single-Dose) Inclisiran group versus Placebo (Single-Dose).|t-test, 1 sided|||||||<0.0001
71055791|NCT02597127|141615945|SUPERIORITY|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 500 mg (Single-Dose) Inclisiran group versus Placebo (Single-Dose).|t-test, 1 sided|||||||<0.0001
71022536|NCT00528879|141553087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.7||||0.0062||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|Modified logistic regression|||||||0.0062
71022537|NCT00528879|141553088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.3515||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.|ANCOVA|||||||
71022538|NCT00528879|141553088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.3022||0.0068||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||0.0068
71022539|NCT00528879|141553088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.3535||0.029||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||0.0290
71022540|NCT00528879|141553089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|0.3681||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.|ANCOVA|||||||
71022541|NCT00528879|141553089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.19|STANDARD_ERROR_OF_MEAN|0.3745|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
71022542|NCT00528879|141553089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.08|STANDARD_ERROR_OF_MEAN|0.3791|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
71022543|NCT00528879|141553096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.1109||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.|ANCOVA|||||||
71022544|NCT00528879|141553096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1129||0.0004||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||0.0004
71022545|NCT00528879|141553096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.1146|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
71022546|NCT00528879|141553097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.1|STANDARD_ERROR_OF_MEAN|2.769||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.|ANCOVA|||||||
71022547|NCT00528879|141553097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.1|STANDARD_ERROR_OF_MEAN|2.762|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
71022548|NCT00528879|141553097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.7|STANDARD_ERROR_OF_MEAN|2.808|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
71022549|NCT00528879|141553098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.9||||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.|Modified logistic regression|||||||
71022550|NCT00528879|141553098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.8627|||||||Modified logistic regression|||||||0.8627
71022551|NCT00528879|141553098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.3||||0.0149||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|Modified logistic regression|||||||0.0149
71022552|NCT00078819|141553099|SUPERIORITY|The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician's global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test stratified by age group||||||<0.0001
71107396|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.1109|TWO_SIDED|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Remission||1.9|0.8|0.1109
71107397|NCT00565409|141721001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.85|||<|0.0001|TWO_SIDED|95.0|2.5|6.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Remission||6.0|2.5|<0.0001
71107398|NCT00565409|141721003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.4|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 40||-0.4|-0.7|<0.0001
71107399|NCT00565409|141721003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9344|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 40||0.2|-0.2|0.9344
71055792|NCT02597127|141615945|SUPERIORITY|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 100 mg Double-Dose) Inclisiran group versus Placebo (Double-Dose).|t-test, 1 sided|||||||<0.0001
71055793|NCT02597127|141615945|SUPERIORITY|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 200 mg Double-Dose) Inclisiran group versus Placebo (Double-Dose).|t-test, 1 sided|||||||<0.0001
71055794|NCT02597127|141615945|SUPERIORITY|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 300 mg Double-Dose) Inclisiran group versus Placebo (Double-Dose).|t-test, 1 sided|||||||<0.0001
71055795|NCT00811928|141615955|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the 95% Confidence Interval for the difference in incidence defined as (# of participants affected with proven or probable IFI/ # of participants in the FAS population at risk)\*100% (posaconazole minus fluconazole) had to be \< 4 in order to be considered non-inferior. IFI occurred: proven+probable|Difference for the incidence|-5.88|||||TWO_SIDED|95.0|-12.21|0.25|||||Posaconazole minus fluconazole|||0.25|-12.21|
71055796|NCT00811928|141615956|SUPERIORITY_OR_OTHER||Percentage of Participants|4.27|||||TWO_SIDED|95.0|1.4|9.7|||||IFI Incidence for the Posaconazole group = (# of participants affected with proven or probable IFI/ # of participants in the FAS population at risk)\*100%|||9.7|1.4|
71055797|NCT00811928|141615956|SUPERIORITY_OR_OTHER||Percentage of Participants|13.68|||||TWO_SIDED|95.0|8.0|21.3|||||IFI Incidence for the Fluconazole group = (# of participants affected with proven or probable IFI/ # of participants in the FAS population at risk)\*100%|||21.3|8.0|
71107400|NCT00565409|141721003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.4|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 40||-0.4|-0.7|<0.0001
71107401|NCT00565409|141721003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 48||-0.7|-1.0|<0.0001
71107402|NCT00565409|141721003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.6173|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 48||0.2|-0.1|0.6173
71107403|NCT00565409|141721003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 48||-0.7|-1.1|<0.0001
71107404|NCT00565409|141721003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 56||-0.7|-1.1|<0.0001
71022553|NCT00078819|141553100|SUPERIORITY|The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician's global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test stratified by age group||||||<0.0001
71055798|NCT00811928|141615959|SUPERIORITY_OR_OTHER||Percentage of Participants|31.62|||||TWO_SIDED|95.0|23.3|40.9|||||IFI Incidence for the Posaconazole group = (# of participants affected with proven or probable IFI/ # of participants in the FAS population at risk)\*100%.|||40.9|23.3|
71055799|NCT00811928|141615959|SUPERIORITY_OR_OTHER||Percentage of Participants|41.88|||||TWO_SIDED|95.0|32.8|51.4|||||IFI Incidence for the Fluconazole group = (# of participants affected with proven or probable IFI/ # of participants in the FAS population at risk)\*100%|||51.4|32.8|
71055800|NCT00811928|141615960|SUPERIORITY_OR_OTHER||Percentage of Participants|2.56|||||TWO_SIDED|95.0|0.5|7.3|||||All-Cause Mortality Rate is the percentage of participants with mortality from any cause.|||7.3|0.5|
71022554|NCT00078819|141553101|SUPERIORITY|The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician's global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test stratified by age group||||||<0.0001
71022555|NCT00078819|141553102|SUPERIORITY|The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician's global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.|||||<|0.0001|||||||Van Elteren test|Two-sided van Elteren's test stratified by age group||||||<0.0001
71022556|NCT00078819|141553103|SUPERIORITY|The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician's global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test stratified by age group||||||<0.0001
71022557|NCT00323609|141553106|SUPERIORITY_OR_OTHER|||||||0.214||95.0|||||Fisher Exact|||||||0.214
71022558|NCT00323609|141553107|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 7 days.||||0.430
71022559|NCT00323609|141553107|SUPERIORITY_OR_OTHER|||||||0.655||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 30 days.||||0.655
71022560|NCT00323609|141553107|SUPERIORITY_OR_OTHER|||||||0.756||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.756
71022561|NCT00323609|141553107|SUPERIORITY_OR_OTHER|||||||0.503||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.503
71022562|NCT00323609|141553107|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.837
71022563|NCT00323609|141553108|SUPERIORITY_OR_OTHER|||||||0.785||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 30 days||||0.785
71022564|NCT00323609|141553108|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.393
71055801|NCT00811928|141615960|SUPERIORITY_OR_OTHER||Percentage of Participants|5.98|||||TWO_SIDED|95.0|2.4|11.9|||||All-Cause Mortality Rate is the percentage of participants with mortality from any cause.|||11.9|2.4|
71055802|NCT01120704|141615983|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.906||||0.045|TWO_SIDED|95.0|0.822|0.998|||Regression, Cox|||The Cox regression model effects consisted of five treatment effects, 10 two-way treatment interactions, 10 three-way treatment interactions, and two covariates : two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||.998|.822|.045
71022565|NCT00323609|141553108|SUPERIORITY_OR_OTHER|||||||0.875||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 12 months||||0.875
71022566|NCT00323609|141553108|SUPERIORITY_OR_OTHER|||||||0.833||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.833
71022567|NCT00323609|141553109|SUPERIORITY_OR_OTHER|||||||0.18||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 PCS result at 30 days.||||0.180
71022568|NCT00323609|141553109|SUPERIORITY_OR_OTHER|||||||0.822||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 PCS result at 3 months||||0.822
71022569|NCT00323609|141553109|SUPERIORITY_OR_OTHER|||||||0.291||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 PCS result at 12 months||||0.291
71022570|NCT00323609|141553109|SUPERIORITY_OR_OTHER|||||||0.996||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 PCS result at 24 months||||0.996
71022571|NCT00323609|141553109|SUPERIORITY_OR_OTHER|||||||0.983||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 MCS result at 30 days||||0.983
71022572|NCT00323609|141553109|SUPERIORITY_OR_OTHER|||||||0.576||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 MCS result at 3 months||||0.576
71022573|NCT00323609|141553109|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 MCS result at 12 months||||0.393
71022574|NCT00323609|141553109|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 MCS result at 24 months||||0.722
71022575|NCT00323609|141553110|SUPERIORITY_OR_OTHER|||||||0.318||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 30 days.||||0.318
71022576|NCT00323609|141553110|SUPERIORITY_OR_OTHER|||||||0.523||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.523
71022577|NCT00323609|141553110|SUPERIORITY_OR_OTHER|||||||0.634||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.634
71022578|NCT00323609|141553110|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.457
71022579|NCT00323609|141553111|SUPERIORITY_OR_OTHER|||||||0.818||95.0|||||Fisher Exact|||||||0.818
71055803|NCT01120704|141615983|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.982||||0.705|TWO_SIDED|95.0|0.892|1.081|||Regression, Cox|||The Cox regression model effects consisted of five treatment effects, 10 two-way treatment interactions, 10 three-way treatment interactions, and two covariates : two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.081|.892|.705
71055804|NCT01120704|141615983|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.044||||0.382|TWO_SIDED|95.0|0.948|1.149|||Regression, Cox|||The Cox regression model effects consisted of five treatment effects, 10 two-way treatment interactions, 10 three-way treatment interactions, and two covariates : two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.149|.948|.382
71055805|NCT01120704|141615983|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.954||||0.339|TWO_SIDED|95.0|0.867|1.05|||Regression, Cox|||The Cox regression model effects consisted of five treatment effects, 10 two-way treatment interactions, 10 three-way treatment interactions, and two covariates : two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.050|.867|.339
71055806|NCT01120704|141615983|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.945||||0.248|TWO_SIDED|95.0|0.858|1.04|||Regression, Cox|||||1.040|.858|.248
71055807|NCT01120704|141615984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.402||||0.011|TWO_SIDED|95.0|1.08|1.821|||Regression, Logistic|||The logistic regression model effects consisted of five treatment main effects and all treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., 8 Weeks of Nicotine Patch and Nicotine Gum vs. 26 Weeks of Nicotine Patch and Nicotine Gum) would result in significantly higher abstinence at 52 weeks after target quit day.||1.821|1.080|.011
71055808|NCT01120704|141615984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.008||||0.956|TWO_SIDED|95.0|0.769|1.321|||Regression, Logistic|||The logistic regression model effects consisted of five treatment main effects and all treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Maintenance Counseling vs. Maintenance Counseling) would result in significantly higher abstinence at 52 weeks after target quit day.||1.321|.769|.956
71055809|NCT01120704|141615984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.018||||0.885|TWO_SIDED|95.0|0.797|1.301|||Regression, Logistic|||The logistic regression model effects consisted of five treatment main effects and all treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Cognitive Medication Adherence Counseling vs. Cognitive Medication Adherence Counseling) would result in significantly higher abstinence at 52 weeks after target quit day.||1.301|.797|.885
71107405|NCT00565409|141721003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.5136|TWO_SIDED|95.0|-0.1|0.3|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 56||0.3|-0.1|0.5136
71107406|NCT00565409|141721003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 56||-0.8|-1.2|<0.0001
71107407|NCT00565409|141721003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 64||-0.7|-1.1|<0.0001
71107408|NCT00565409|141721003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.4868|TWO_SIDED|95.0|-0.1|0.3|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 64||0.3|-0.1|0.4868
71107409|NCT00565409|141721003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 64||-0.7|-1.1|<0.0001
71107410|NCT00565409|141721003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 72||-0.8|-1.3|<0.0001
71107411|NCT00565409|141721003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.7847|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 72||0.2|-0.2|0.7847
71107412|NCT00565409|141721003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 72||-0.8|-1.2|<0.0001
71107413|NCT00565409|141721003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 80||-0.8|-1.2|<0.0001
71107414|NCT00565409|141721003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.981|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 80||0.2|-0.2|0.9810
71107415|NCT00565409|141721003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 80||-0.8|-1.2|<0.0001
71107416|NCT00565409|141721003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 88||-0.8|-1.3|<0.0001
71107417|NCT00565409|141721003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3562|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 88||0.1|-0.3|0.3562
71022580|NCT00323609|141553112|SUPERIORITY_OR_OTHER|||||||0.226||95.0|||||Fisher Exact|||||||0.226
71022581|NCT00323609|141553113|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
71022582|NCT00323609|141553114|SUPERIORITY_OR_OTHER|||||||0.112||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at pre-discharge.||||0.112
71022583|NCT00323609|141553114|SUPERIORITY_OR_OTHER|||||||0.364||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.364
71022584|NCT00323609|141553114|SUPERIORITY_OR_OTHER|||||||0.185||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.185
71055810|NCT01120704|141615984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.852||||0.205|TWO_SIDED|95.0|0.664|1.092|||Regression, Logistic|||The logistic regression model effects consisted of five treatment main effects and all treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., Electronic Medication Monitoring Device Without Feedback vs. Electronic Medication Monitoring Device Plus Feedback) would result in significantly higher abstinence at 52 weeks after target quit day.||1.092|.664|.205
71055811|NCT01120704|141615984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.514|TWO_SIDED|95.0|0.842|1.411|||Regression, Logistic|||The logistic regression model effects consisted of five treatment main effects and all treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Automated Adherence Prompting Phone Calls vs. Automated Adherence Prompting Phone Calls) would result in significantly higher abstinence at 52 weeks after target quit day.||1.411|.842|.514
71055812|NCT04181723|141615989|SUPERIORITY||LSM difference|-3.1|STANDARD_ERROR_OF_MEAN|1.3||0.0175|TWO_SIDED|95.0|-5.7|-0.6|||Mixed-effects model for repeated measure|||||-0.6|-5.7|0.0175
71055813|NCT04181723|141615990|SUPERIORITY||LSM difference|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.003|TWO_SIDED|95.0|-0.5|-0.1|||Mixed-effects model for repeated measure|||||-0.1|-0.5|0.0030
71055814|NCT04181723|141615991|SUPERIORITY||LSM difference|1.0|STANDARD_ERROR_OF_MEAN|0.37||0.0064|TWO_SIDED|95.0|0.3|1.7|||Mixed-effects model for repeated measure|||||1.7|0.3|0.0064
71055815|NCT04181723|141615992|SUPERIORITY||LSM difference|-4.5|STANDARD_ERROR_OF_MEAN|4.67||0.3376|TWO_SIDED|95.0|-13.8|4.8|||ANCOVA|||||4.8|-13.8|0.3376
71055816|NCT04181723|141615993|SUPERIORITY||LSM difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.3649|TWO_SIDED|95.0|-0.3|0.1|||Mixed-effects model for repeated measure|||||0.1|-0.3|0.3649
71107418|NCT00565409|141721003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 88||-0.7|-1.2|<0.0001
71107419|NCT00565409|141721004|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Week 88 censored data was censored at 372 days.|Log Rank|||Imputation of failure defined as participants who did not reach the endpoint and discontinued due to lack of efficacy, with reason of unsatisfactory response-efficacy, adverse event, other or protocol violation were set to an event at time of discontinuation.||||<0.0001
71055817|NCT04181723|141615994|SUPERIORITY||LSM difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.2114|TWO_SIDED|95.0|-0.3|0.1|||Mixed-effects model for repeated measure|||||0.1|-0.3|0.2114
71055818|NCT04181723|141615995|SUPERIORITY||LSM difference|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.0257|TWO_SIDED|95.0|-0.6|0.0|||Mixed-effects model for repeated measure|||||0.0|-0.6|0.0257
71055819|NCT04181723|141615996|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.9799|TWO_SIDED|95.0|-0.2|0.2|||Mixed-effects model for repeated measure|||||0.2|-0.2|0.9799
71055820|NCT04181723|141615997|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.5304|TWO_SIDED|95.0|-0.1|0.1|||Mixed-effects model for repeated measure|||||0.1|-0.1|0.5304
71055821|NCT04181723|141615998|SUPERIORITY||LSM difference|-0.8|STANDARD_ERROR_OF_MEAN|1.4||0.5855|TWO_SIDED|95.0|-3.5|2.0|||ANCOVA|||||2.0|-3.5|0.5855
71055822|NCT04181723|141615999|SUPERIORITY||LSM difference|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.2507|TWO_SIDED|95.0|-0.1|0.4|||Mixed-effects model for repeated measure|||||0.4|-0.1|0.2507
71107420|NCT00565409|141721004|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Week 88 censored data was censored at 372 days.|Log Rank|||Imputation of failure defined as participants who did not reach the endpoint and discontinued due to lack of efficacy, with reason of unsatisfactory response-efficacy, adverse event, other or protocol violation were set to an event at time of discontinuation.||||<0.0001
70851442|NCT05487196|141190891|NON_INFERIORITY|The noninferiority margin δ was set as the median of fentanyl group + 30 representing a 1-point pain numeric rating scale difference per unit time across the 30-minute initiation period. A conventional 1-sided 95% confidence interval (CI) was constructed using normal distribution assumptions. Analysis was by intent to treat. Comparisons of PI-AUC30 between the three agents were made by one-way ANOVA.||||||0.226|||||||ANOVA|||||||0.226
70851443|NCT05487196|141190892|SUPERIORITY|||||||0.16|||||||ANOVA|||||||0.16
71055823|NCT03332979|141616000|OTHER|Multivariable regression analysis will be used to enable us to explore the impact of modifiable factors reflecting preparation for end of life on the MMCGI-SF.|||||<|0.05|||||||Regression, Linear||||Multivariable regression will be used to explore preparation for end of life on the MMCGI-SF. The analyses will use the MMCGI-SF as the dependent variable with five predictor variables (dementia knowledge \[DKAS\], Social support \[HLQ1\], Communication with healthcare professionals \[HLW4\], advance decisions and knowledge of end of life wishes of person with dementia. There will also be 10 confounders included in the model (gender of caregiver, living arrangement of person with dementia \[at home of a care home\], aged of person with dementia, dementia severity \[CDR\], change in closeness, religiosity \[DURAL\], deprivation and relationship of the carer to the person with dementia).|||<0.05
71055824|NCT05147324|141616008|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.70
71055825|NCT05147324|141616009|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.70
71055826|NCT05147324|141616017|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
71055827|NCT00205803|141616071|SUPERIORITY_OR_OTHER||Difference|-2.26|||||TWO_SIDED|95.0|-8.08|2.33||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.33|-8.08|
71055828|NCT00205803|141616071|SUPERIORITY_OR_OTHER||Difference|-0.49|||||TWO_SIDED|95.0|-9.93|8.65||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||8.65|-9.93|
70851444|NCT05487196|141190893|SUPERIORITY|||||||0.03|||||||ANOVA|||||||0.03
71055829|NCT00205803|141616071|SUPERIORITY_OR_OTHER||Difference|-2.27|||||TWO_SIDED|95.0|-8.07|2.26||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.26|-8.07|
71055830|NCT00205803|141616071|SUPERIORITY_OR_OTHER||Difference|0.68||||||95.0|-4.96|6.16||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||6.16|-4.96|
71055831|NCT00205803|141616071|SUPERIORITY_OR_OTHER||Difference|-2.25||||||95.0|-8.18|2.36||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.36|-8.18|
71107421|NCT00565409|141721004|SUPERIORITY_OR_OTHER|||||||0.8622|TWO_SIDED|||||Week 88 censored data was censored at 372 days.|Log Rank|||Imputation of failure defined as participants who did not reach the endpoint and discontinued due to lack of efficacy, with reason of unsatisfactory response-efficacy, adverse event, other or protocol violation were set to an event at time of discontinuation.||||0.8622
71107422|NCT00565409|141721005|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Week 88 censored data was censored at 372 days.|Log Rank|||||||<0.0001
70851445|NCT05487196|141190894|SUPERIORITY|||||||0.07|||||||ANOVA|||||||0.07
70851446|NCT05487196|141190895|SUPERIORITY|||||||0.22|||||||ANOVA|||||||0.22
70851447|NCT05487196|141190896|SUPERIORITY|||||||0.28|||||||Fisher Exact|||||||0.28
70851448|NCT05487196|141190897|SUPERIORITY|||||||0.83|||||||Fisher Exact|||||||0.83
70851449|NCT05487196|141190898|SUPERIORITY|||||||0.01|||||||Fisher Exact|||||||0.01
70851450|NCT05487196|141190899|SUPERIORITY|||||||0.36|||||||Fisher Exact|||||||0.36
70851451|NCT05487196|141190900|SUPERIORITY|||||||0.36|||||||Fisher Exact|||||||0.36
70851452|NCT05487196|141190901|SUPERIORITY|||||||0.54|||||||Fisher Exact|||||||0.54
71055832|NCT00205803|141616071|SUPERIORITY_OR_OTHER||Difference|0.7||||||95.0|-4.84|6.32||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||6.32|-4.84|
71055833|NCT00205803|141616071|SUPERIORITY_OR_OTHER||Difference|-0.69||||||95.0|-7.75|5.86||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||5.86|-7.75|
71055834|NCT00205803|141616071|SUPERIORITY_OR_OTHER||Difference|72.87||||||95.0|63.32|81.07||||||For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||81.07|63.32|
71055835|NCT00205803|141616071|SUPERIORITY_OR_OTHER||Difference|84.92||||||95.0|76.73|91.05||||||For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||91.05|76.73|
71055836|NCT00205803|141616071|SUPERIORITY_OR_OTHER||Difference|57.94||||||95.0|48.01|67.42||||||For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||67.42|48.01|
71055837|NCT00205803|141616071|SUPERIORITY_OR_OTHER||Difference|62.81||||||95.0|52.33|72.2||||||For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||72.20|52.33|
71055838|NCT00205803|141616071|SUPERIORITY_OR_OTHER||Difference|92.27||||||95.0|85.26|96.54||||||For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||96.54|85.26|
71055839|NCT00205803|141616071|SUPERIORITY_OR_OTHER||Difference|5.61||||||95.0|1.23|11.86||||||For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||11.86|1.23|
71055840|NCT00205803|141616072|SUPERIORITY_OR_OTHER||Difference|-1.5||||||95.0|-7.9|3.6||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.6|-7.9|
71055841|NCT00205803|141616072|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-4.6|4.0||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.0|-4.6|
71055842|NCT00205803|141616072|SUPERIORITY_OR_OTHER||Difference|-1.3||||||95.0|-6.9|2.8||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.8|-6.9|
71055843|NCT00205803|141616072|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-4.6|4.0||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.0|-4.6|
71055844|NCT00205803|141616072|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-4.7|3.9||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.9|-4.7|
71055845|NCT00205803|141616072|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-4.6|4.0||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.0|-4.6|
71107423|NCT00565409|141721005|SUPERIORITY_OR_OTHER|||||||0.9841|TWO_SIDED|||||Week 88 censored data was censored at 372 days.|Log Rank|||||||0.9841
71107424|NCT00565409|141721005|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Week 88 censored data was censored at 372 days.|Log Rank|||||||<0.0001
71107425|NCT00565409|141721009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.5|-1.1|<0.0001
71107426|NCT00565409|141721009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.8015|TWO_SIDED|95.0|-0.3|0.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||0.3|-0.3|0.8015
70851453|NCT05487196|141190902|SUPERIORITY|||||||0.58|||||||Kruskal-Wallis|||||||0.58
71022585|NCT00323609|141553114|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.100
71022586|NCT00323609|141553115|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at pre-discharge.||||0.005
71022587|NCT00323609|141553115|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.382
71022588|NCT00323609|141553115|SUPERIORITY_OR_OTHER|||||||0.196||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.196
71055846|NCT00205803|141616072|SUPERIORITY_OR_OTHER||Difference|2.2||||||95.0|-2.6|7.7||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||7.7|-2.6|
71107427|NCT00565409|141721009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.5|-1.1|<0.0001
70851454|NCT05487196|141190903|SUPERIORITY|||||||0.98|||||||Kruskal-Wallis|||||||0.98
70851455|NCT03009396|141190926|SUPERIORITY|||||||0.2112|||||||Log Rank|||||||0.2112
70851456|NCT03009396|141190927|SUPERIORITY|||||||0.0356|||||||Log Rank|||||||0.0356
70851457|NCT03009396|141190928|SUPERIORITY|||||||0.0514|||||||Log Rank|||||||0.0514
70851458|NCT03009396|141190929|SUPERIORITY|||||||0.1259|||||||Log Rank|||||||0.1259
70851459|NCT03009396|141190930|SUPERIORITY|||||||0.4114|||||||Fisher Exact|||||||0.4114
70851460|NCT02872285|141190934|SUPERIORITY||Mean Difference (Final Values)|-12.8||||0.2205|TWO_SIDED|95.0|-33.793|8.199||ANCOVA was used to compare mean percent change in PASI score between baseline and Week 12 between LYC-30937 and placebo treatment groups with treatment as a factor and baseline as a covariate.|ANCOVA|||Subjects included in this analysis had to have both a baseline and Week 12 PASI scores.||8.199|-33.793|0.2205
70851461|NCT02872285|141190935|SUPERIORITY|||||||0.4712|||||||Chi-squared|2-sided p-value.||||||0.4712
70851462|NCT02872285|141190936|SUPERIORITY||Mean Difference (Final Values)|-5.34||||0.6695|TWO_SIDED|95.0|-30.87|20.18|||ANCOVA|||||20.18|-30.87|0.6695
70851463|NCT02872285|141190937|SUPERIORITY|||||||0.4712||||||2-sided p-value|Chi-squared|||||||0.4712
70851464|NCT02872285|141190938|SUPERIORITY|||||||0.4712||||||2-sided p-value|Chi-squared|||||||0.4712
70851465|NCT05477108|141190939|EQUIVALENCE|For Cmax, the intra-participant CV% in Treatment B (reference arm) was 42.91. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.1028 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|104.24|||||TWO_SIDED|90.0|95.78|113.44|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Budesonide Pharmacokinetic Parameters (US approach)||113.44|95.78|
70851466|NCT05477108|141190939|EQUIVALENCE|For Cmax, the intra-participant CV% in Treatment B (reference arm) was 40.85. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.0831 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|93.45|||||TWO_SIDED|90.0|84.31|103.58|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Glycopyrronium Pharmacokinetic Parameters (US approach)||103.58|84.31|
70851467|NCT05477108|141190939|EQUIVALENCE|For Cmax, the intra-participant CV% in Treatment B (reference arm) was 40.66. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.0971 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|100.14|||||TWO_SIDED|90.0|91.9|109.11|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Formoterol Pharmacokinetic Parameters (US approach)||109.11|91.90|
70933574|NCT01968967|141368259|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|25.5|||||TWO_SIDED|95.0|18.9|34.47||||||Week 52: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||34.47|18.90|
71022589|NCT00323609|141553115|SUPERIORITY_OR_OTHER|||||||0.281||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.281
71022590|NCT00323609|141553116|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at pre-discharge.||||0.033
71022591|NCT00323609|141553116|SUPERIORITY_OR_OTHER|||||||0.981||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.981
71022592|NCT00323609|141553116|SUPERIORITY_OR_OTHER|||||||0.631||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.631
71055847|NCT00205803|141616072|SUPERIORITY_OR_OTHER||Difference|97.8||||||95.0|92.3|99.7||||||For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||99.7|92.3|
71055848|NCT00205803|141616072|SUPERIORITY_OR_OTHER||Difference|83.6||||||95.0|73.2|90.8||||||For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||90.8|73.2|
71107428|NCT00565409|141721009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-0.7|-1.5|<0.0001
71107429|NCT00565409|141721009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.8534|TWO_SIDED|95.0|-0.4|0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||0.4|-0.4|0.8534
71107430|NCT00565409|141721009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-0.8|-1.6|<0.0001
71107431|NCT00565409|141721009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-0.8|-1.7|<0.0001
71107432|NCT00565409|141721009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.9074|TWO_SIDED|95.0|-0.4|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||0.5|-0.4|0.9074
71107433|NCT00565409|141721009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-0.8|-1.7|<0.0001
71107434|NCT00565409|141721009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28|||<|0.0001|TWO_SIDED|95.0|-1.8|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-0.8|-1.8|<0.0001
71107435|NCT00565409|141721009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.9229|TWO_SIDED|95.0|-0.4|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||0.5|-0.4|0.9229
71107436|NCT00565409|141721009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.8|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-0.8|-1.8|<0.0001
71107437|NCT00565409|141721009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.44|||<|0.0001|TWO_SIDED|95.0|-1.9|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-1.0|-1.9|<0.0001
70933575|NCT00176202|141368276|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared|||||||<0.01
70933576|NCT00176202|141368276|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared|||||||<0.01
71107438|NCT00565409|141721009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.9279|TWO_SIDED|95.0|-0.5|0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||0.4|-0.5|0.9279
71107439|NCT00565409|141721009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.42|||<|0.0001|TWO_SIDED|95.0|-1.9|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-1.0|-1.9|<0.0001
71107440|NCT00565409|141721009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.58|||<|0.0001|TWO_SIDED|95.0|-2.1|-1.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.1|-2.1|<0.0001
71107441|NCT00565409|141721009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.7695|TWO_SIDED|95.0|-0.6|0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||0.4|-0.6|0.7695
71107442|NCT00565409|141721009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|||<|0.0001|TWO_SIDED|95.0|-2.0|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.0|-2.0|<0.0001
71107443|NCT00565409|141721009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75|||<|0.0001|TWO_SIDED|95.0|-2.3|-1.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-1.2|-2.3|<0.0001
70933577|NCT00176202|141368277|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared|||||||<.01
70933578|NCT00176202|141368277|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Chi-squared|||||||0.01
70933579|NCT00176202|141368278|SUPERIORITY_OR_OTHER||effect size|-1.59|||<|0.01|TWO_SIDED|||||In case of both risperidone and divalproex sodium.|Chi-squared|||||||<0.01
70933580|NCT00176202|141368278|SUPERIORITY_OR_OTHER||Effect size|-1.33|||<|0.01|TWO_SIDED||||||Chi-squared|||||||<0.01
70933581|NCT00176202|141368279|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared|||baseline is compared to LOCF to determine the p value.||||<0.01
70933582|NCT00176202|141368279|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared|||||||<0.01
70933583|NCT06193590|141368298|SUPERIORITY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||||||0.21
71107444|NCT00565409|141721009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.2182|TWO_SIDED|95.0|-0.8|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||0.2|-0.8|0.2182
71107445|NCT00565409|141721009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.44|||<|0.0001|TWO_SIDED|95.0|-1.9|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-0.9|-1.9|<0.0001
71107446|NCT00565409|141721012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86||||0.0003|TWO_SIDED|95.0|-1.3|-0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.4|-1.3|0.0003
70933584|NCT06193590|141368299|SUPERIORITY|||||||0.1|||||||Fisher Exact|||||||0.1
70933585|NCT06193590|141368301|SUPERIORITY|||||||0.001|||||||Fisher Exact|||||||0.001
70933586|NCT03683576|141368311|SUPERIORITY||Odds Ratio (OR)|0.674||||0.1425|TWO_SIDED|95.0|0.398|1.142|||Regression, Logistic||GB001 20 mg vs. Placebo|||1.142|0.398|0.1425
70933587|NCT03683576|141368311|SUPERIORITY||Odds Ratio (OR)|0.677||||0.1482|TWO_SIDED|95.0|0.399|1.149|||Regression, Logistic||GB001 40 mg vs. Placebo|||1.149|0.399|0.1482
70933588|NCT03683576|141368311|SUPERIORITY||Odds Ratio (OR)|0.651||||0.1086|TWO_SIDED|95.0|0.385|1.1|||Regression, Logistic||GB001 60 mg vs. Placebo|||1.100|0.385|0.1086
70933589|NCT03683576|141368312|SUPERIORITY||Mean Difference (Net)|-0.15||||0.1647|TWO_SIDED|95.0|-0.36|0.06|||ANCOVA||GB001 20 mg vs. Placebo|||0.06|-0.36|0.1647
70933590|NCT03683576|141368312|SUPERIORITY||Mean Difference (Net)|-0.15||||0.1737|TWO_SIDED|95.0|-0.37|0.07|||ANCOVA||GB001 40 mg vs. Placebo|||0.07|-0.37|0.1737
70933591|NCT03683576|141368312|SUPERIORITY||Mean Difference (Net)|-0.19||||0.0879|TWO_SIDED|95.0|-0.4|0.03|||ANCOVA||GB001 60 mg vs. Placebo|||0.03|-0.40|0.0879
70933592|NCT03683576|141368313|SUPERIORITY||Mean Difference (Net)|0.016||||0.7718|TWO_SIDED|95.0|-0.091|0.123|||ANCOVA||GB001 20 mg vs. Placebo|||0.123|-0.091|0.7718
70933593|NCT03683576|141368313|SUPERIORITY||Mean Difference (Net)|0.041||||0.4562|TWO_SIDED|95.0|-0.067|0.149|||ANCOVA||GB001 40 mg vs. Placebo|||0.149|-0.067|0.4562
70933594|NCT03683576|141368313|SUPERIORITY||Mean Difference (Net)|0.075||||0.1631|TWO_SIDED|95.0|-0.03|0.18|||ANCOVA||GB001 60 mg vs. Placebo|||0.180|-0.030|0.1631
70933595|NCT03683576|141368314|SUPERIORITY||Hazard Ratio (HR)|0.719||||0.0466|TWO_SIDED|95.0|0.519|0.995|||Regression, Cox||GB001 20 mg vs. Placebo|||0.995|0.519|0.0466
71107447|NCT00565409|141721012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.6088|TWO_SIDED|95.0|-0.3|0.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||0.6|-0.3|0.6088
71107448|NCT00565409|141721012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.5|-1.4|<0.0001
70933596|NCT03683576|141368314|SUPERIORITY||Hazard Ratio (HR)|0.773||||0.1222|TWO_SIDED|95.0|0.558|1.071|||Regression, Cox||GB001 40 mg vs. Placebo|||1.071|0.558|0.1222
70933597|NCT03683576|141368314|SUPERIORITY||Hazard Ratio (HR)|0.698||||0.0304|TWO_SIDED|95.0|0.505|0.967|||Regression, Cox||GB001 60 mg vs. Placebo|||0.967|0.505|0.0304
70933598|NCT03683576|141368315|SUPERIORITY||Rate ratio|0.797||||0.3382|TWO_SIDED|95.0|0.501|1.268|||Negative binomial regression model||GB001 20 mg vs. Placebo|||1.268|0.501|0.3382
70933599|NCT03683576|141368315|SUPERIORITY||Rate ratio|0.748||||0.2248|TWO_SIDED|95.0|0.469|1.195|||Negative binomial regression model||GB001 40 mg vs. Placebo|||1.195|0.469|0.2248
70933600|NCT03683576|141368315|SUPERIORITY||Rate ratio|0.889||||0.609|TWO_SIDED|95.0|0.565|1.397|||Negative binomial regression model||GB001 60 mg vs. Placebo|||1.397|0.565|0.6090
70933601|NCT03683576|141368316|SUPERIORITY||Mean Difference (Net)|-0.023||||0.6645|TWO_SIDED|95.0|-0.127|0.081|||ANCOVA||GB001 20 mg vs. Placebo|||0.081|-0.127|0.6645
70933602|NCT03683576|141368316|SUPERIORITY||Mean Difference (Net)|0.035||||0.5288|TWO_SIDED|95.0|-0.074|0.144|||ANCOVA||GB001 40 mg vs. Placebo|||0.144|-0.074|0.5288
70933603|NCT03683576|141368316|SUPERIORITY||Mean Difference (Net)|0.079||||0.1362|TWO_SIDED|95.0|-0.025|0.182|||ANCOVA||GB001 60 mg vs. Placebo|||0.182|-0.025|0.1362
70933604|NCT03683576|141368317|SUPERIORITY||Mean Difference (Net)|6.122||||0.3957|TWO_SIDED|95.0|-8.007|20.251|||ANCOVA||GB001 20 mg vs. Placebo|||20.251|-8.007|0.3957
70933605|NCT03683576|141368317|SUPERIORITY||Mean Difference (Net)|13.948||||0.0598|TWO_SIDED|95.0|-0.578|28.474|||ANCOVA||GB001 40 mg vs. Placebo|||28.474|-0.578|0.0598
70933606|NCT03683576|141368317|SUPERIORITY||Mean Difference (Net)|5.588||||0.4376|TWO_SIDED|95.0|-8.522|19.698|||ANCOVA||GB001 60 mg vs. Placebo|||19.698|-8.522|0.4376
70933607|NCT03499964|141368342|SUPERIORITY||||||<|0.0001|||||||Chi-squared, Corrected|||||||<0.0001
70933608|NCT03499964|141368344|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
70933609|NCT02909959|141368346|EQUIVALENCE|Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96\*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.|Mean Difference (Final Values)|2.96|STANDARD_ERROR_OF_MEAN|3.03||0.331|TWO_SIDED|||||The test was considered statistically significant if the p-value \< 0.05.|Mixed Models Analysis|Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.|This analysis compares LS Mean Sulforaphane - LS Mean Placebo.|The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.||||0.331
70933610|NCT02909959|141368347|EQUIVALENCE|Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96\*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|2.99||0.98|TWO_SIDED|||||The test was considered statistically significant if the p-value \< 0.05.|Mixed Models Analysis|Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.|This analysis compares LS Mean Sulforaphane - LS Mean Placebo.|The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.||||0.98
70933611|NCT02909959|141368348|EQUIVALENCE|Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96\*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.|Mean Difference (Final Values)|-0.774|STANDARD_ERROR_OF_MEAN|2.99||0.797|TWO_SIDED|||||The test was considered statistically significant if the p-value \< 0.05.|Mixed Models Analysis|Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.|This analysis compares LS Mean Sulforaphane - LS Mean Placebo.|The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.||||0.797
71022593|NCT00323609|141553116|SUPERIORITY_OR_OTHER|||||||0.79||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.790
70933612|NCT02909959|141368349|EQUIVALENCE|Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96\*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.|Mean Difference (Final Values)|2.32|STANDARD_ERROR_OF_MEAN|3.01||0.442|TWO_SIDED|||||The test was considered statistically significant if the p-value \< 0.05.|Mixed Models Analysis|Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.|This analysis compares LS Mean Sulforaphane - LS Mean Placebo.|The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.||||0.442
70933613|NCT02909959|141368350|EQUIVALENCE|Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96\*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.|Mean Difference (Final Values)|2.72|STANDARD_ERROR_OF_MEAN|3.05||0.373|TWO_SIDED|||||The test was considered statistically significant if the p-value \< 0.05.|Mixed Models Analysis|Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.|This analysis compares LS Mean Sulforaphane - LS Mean Placebo.|The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.||||0.373
70933614|NCT03739866|141368396|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70933615|NCT03739866|141368396|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70933616|NCT03739866|141368396|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71055849|NCT00205803|141616072|SUPERIORITY_OR_OTHER||Difference|29.5||||||95.0|19.7|40.9||||||For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||40.9|19.7|
71055850|NCT00205803|141616072|SUPERIORITY_OR_OTHER||Difference|12.0||||||95.0|5.9|20.4||||||For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||20.4|5.9|
71055851|NCT00205803|141616072|SUPERIORITY_OR_OTHER||Difference|94.1||||||95.0|86.8|98.1||||||For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||98.1|86.8|
71055852|NCT00205803|141616072|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-4.6|4.0||||||For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.0|-4.6|
71055853|NCT00205803|141616073|SUPERIORITY_OR_OTHER||Ratio|0.76||||||95.0|0.59|0.96||||||For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated||0.96|0.59|
71055854|NCT00205803|141616073|SUPERIORITY_OR_OTHER||Ratio|0.96||||||95.0|0.62|1.48||||||For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated||1.48|0.62|
71055855|NCT00205803|141616073|SUPERIORITY_OR_OTHER||Difference|0.85||||||95.0|0.69|1.05||||||For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated||1.05|0.69|
71055856|NCT00205803|141616073|SUPERIORITY_OR_OTHER||Ratio|0.82||||||95.0|0.6|1.11||||||For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated||1.11|0.60|
71055857|NCT00205803|141616073|SUPERIORITY_OR_OTHER||Ratio|0.62||||||95.0|0.49|0.79||||||For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated||0.79|0.49|
71055858|NCT00205803|141616073|SUPERIORITY_OR_OTHER||Ratio|0.86||||||95.0|0.67|1.09||||||For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated||1.09|0.67|
71055859|NCT00205803|141616073|SUPERIORITY_OR_OTHER||Ratio|0.77||||||95.0|0.59|1.0||||||For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated||1.00|0.59|
71055860|NCT00205803|141616073|SUPERIORITY_OR_OTHER||Ratio|39.78||||||95.0|27.47|57.63||||||For serotype 1 the GMC ratio (13vPnC/7vPnC) was calculated||57.63|27.47|
71055861|NCT00205803|141616073|SUPERIORITY_OR_OTHER||Ratio|15.56||||||95.0|11.63|20.81||||||For serotype 3 the GMC ratio (13vPnC/7vPnC) was calculated||20.81|11.63|
71055862|NCT00205803|141616073|SUPERIORITY_OR_OTHER||Ratio|8.67||||||95.0|6.65|11.29||||||For serotype 5 the GMC ratio (13vPnC/7vPnC) was calculated||11.29|6.65|
71055863|NCT00205803|141616073|SUPERIORITY_OR_OTHER||Ratio|9.6||||||95.0|7.07|13.04||||||For serotype 6A the GMC ratio (13vPnC/7vPnC) was calculated||13.04|7.07|
71055864|NCT00205803|141616073|SUPERIORITY_OR_OTHER||Ratio|26.78||||||95.0|20.97|34.22||||||For serotype 7F the GMC ratio (13vPnC/7vPnC) was calculated||34.22|20.97|
71055865|NCT00205803|141616073|SUPERIORITY_OR_OTHER||Ratio|1.71||||||95.0|1.36|2.16||||||For serotype 19A the GMC ratio (13vPnC/7vPnC) was calculated||2.16|1.36|
71055866|NCT00205803|141616075|SUPERIORITY_OR_OTHER||Difference|3.08||||||95.0|-7.22|13.73||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated||13.73|-7.22|
71055867|NCT00205803|141616075|SUPERIORITY_OR_OTHER||Difference|7.02||||||95.0|-7.28|21.14||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated||21.14|-7.28|
71055868|NCT00205803|141616075|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-9.38|7.73||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL and 0.1 IU/mL thresholds was calculated||7.73|-9.38|
71055869|NCT00205803|141616075|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-9.38|7.73||||||For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL and 0.1 IU/mL thresholds was calculated||7.73|-9.38|
71055870|NCT00205803|141616075|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-5.97|5.68||||||For Polio Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated||5.68|-5.97|
70933617|NCT03739866|141368396|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71055871|NCT00205803|141616075|SUPERIORITY_OR_OTHER||Difference|-1.64||||||95.0|-8.8|4.24||||||For Polio Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated||4.24|-8.80|
70851468|NCT05477108|141190939|EQUIVALENCE|For Cmax, the analysis was conducted using an analysis of variance including fixed effects for treatment, sequence, period and subject within sequence. The PK parameter was log-transformed prior to analysis. The intra-participant CV% in Treatment B (reference arm) was 42.66. Bioequivalence was concluded since the 90% CI for the geometric mean ratio were within the expanded equivalence limits of 73.29% to 136.44% and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|103.12|||||TWO_SIDED|90.0|94.44|112.6|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Budesonide Pharmacokinetic Parameters (EU approach)||112.60|94.44|
70851469|NCT05477108|141190939|EQUIVALENCE|For Cmax, the analysis was conducted using an analysis of variance including fixed effects for treatment, sequence, period and subject within sequence. The PK parameter was log-transformed prior to analysis. The intra-participant CV% in Treatment B (reference arm) was 40.75. Bioequivalence was concluded since the 90% CI for the geometric mean ratio were within the expanded equivalence limits of 74.24% to 134.70% and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|93.39|||||TWO_SIDED|90.0|85.29|102.26|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Glycopyrronium Pharmacokinetic Parameters (EU approach)||102.26|85.29|
70851470|NCT05477108|141190939|EQUIVALENCE|For Cmax, the analysis was conducted using an analysis of variance including fixed effects for treatment, sequence, period and subject within sequence. The PK parameter was log-transformed prior to analysis. The intra-participant CV% in Treatment B (reference arm) was 40.81. Bioequivalence was concluded since the 90% CI for the geometric mean ratio were within the expanded equivalence limits of 74.21% to 134.75% and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|99.7|||||TWO_SIDED|90.0|91.44|108.71|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Formoterol Pharmacokinetic Parameters (EU approach)||108.71|91.44|
70851471|NCT05477108|141190940|EQUIVALENCE|For AUCinf, the intra-participant CV% in Treatment B (reference arm) was 34.29. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.0593 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|107.76|||||TWO_SIDED|90.0|100.35|115.72|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Budesonide Pharmacokinetic Parameters (US approach)||115.72|100.35|
70851472|NCT05477108|141190940|EQUIVALENCE|For AUCinf, the intra-participant CV% in Treatment B (reference arm) was 86.08. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.2925 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Ratio Mean (%)|112.22|||||TWO_SIDED|90.0|92.27|136.49|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Glycopyrronium Pharmacokinetic Parameters (US approach)||136.49|92.27|
70851473|NCT05477108|141190940|EQUIVALENCE|For AUCinf, the intra-participant CV% in Treatment B (reference arm) was 47.07. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.1250 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|101.45|||||TWO_SIDED|90.0|91.76|112.15|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Formoterol Pharmacokinetic Parameters (US approach)||112.15|91.76|
70851474|NCT05477108|141190941|EQUIVALENCE|For AUClast, the intra-participant CV% in Treatment B (reference arm) was 35.68. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.0668 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|106.87|||||TWO_SIDED|90.0|99.3|115.01|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Budesonide Pharmacokinetic Parameters (US approach)||115.01|99.30|
71055872|NCT00205803|141616075|SUPERIORITY_OR_OTHER||Difference|-1.64||||||95.0|-8.8|4.21||||||For Polio Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated||4.21|-8.80|
71055873|NCT00205803|141616075|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-9.38|7.73||||||For Hepatitis b the difference in percentage between the two groups (13vPnC - 7vPnC) at 10 mIU/mL threshold was calculated||7.73|-9.38|
70933618|NCT03739866|141368396|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71055874|NCT00205803|141616075|SUPERIORITY_OR_OTHER||Difference|-1.74||||||95.0|-11.0|6.99||||||For Pertussis - FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 82.00 EU/MI threshold was calculated||6.99|-11.00|
70941658|NCT04748445|141383934|OTHER||Slope|1.209|STANDARD_ERROR_OF_MEAN|7.569||0.1126|TWO_SIDED|90.0|-4.48|2.464|||Mixed Models Analysis|||MM\_MFCC mean 07 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and estimated value it was 10\^-1. For lower limit it was 10\^-3. For dispersion value it was 10\^-2).||2.464|-4.480|0.1126
71055875|NCT00205803|141616075|SUPERIORITY_OR_OTHER||Difference|-6.36||||||95.0|-17.03|3.16||||||For Pertussis - PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 43.00 EU/mL threshold was calculated||3.16|-17.03|
71055876|NCT00205803|141616075|SUPERIORITY_OR_OTHER||Difference|1.33||||||95.0|-6.79|9.68||||||For Pertussis - Pertactin the difference in percentage between the two groups (13vPnC - 7vPnC) at 18.00 EU/mL threshold was calculated||9.68|-6.79|
71055877|NCT00205803|141616076|SUPERIORITY_OR_OTHER||Ratio|1.21|||||TWO_SIDED|95.0|0.69|2.14||||||||2.14|0.69|
71055878|NCT00205803|141616077|SUPERIORITY_OR_OTHER||Ratio|0.97|||||TWO_SIDED|95.0|0.63|1.48||||||||1.48|0.63|
71055879|NCT00205803|141616078|SUPERIORITY_OR_OTHER||Ratio|0.83|||||TWO_SIDED|95.0|0.57|1.21||||||||1.21|0.57|
71055880|NCT00205803|141616079|SUPERIORITY_OR_OTHER||Ratio|1.01|||||TWO_SIDED|95.0|0.66|1.53||||||Polio Type 1||1.53|0.66|
71055881|NCT00205803|141616079|SUPERIORITY_OR_OTHER||Ratio|0.91|||||TWO_SIDED|95.0|0.56|1.49||||||Polio Type 2||1.49|0.56|
71055882|NCT00205803|141616079|SUPERIORITY_OR_OTHER||Ratio|1.12|||||TWO_SIDED|95.0|0.69|1.84||||||Polio Type 3||1.84|0.69|
71055883|NCT00205803|141616080|SUPERIORITY_OR_OTHER||Ratio|0.92|||||TWO_SIDED|95.0|0.74|1.15||||||Pertussis - FHA||1.15|0.74|
71055884|NCT00205803|141616080|SUPERIORITY_OR_OTHER||Ratio|1.02|||||TWO_SIDED|95.0|0.83|1.25||||||Pertussis - PT||1.25|0.83|
70933619|NCT01728324|141368410|SUPERIORITY_OR_OTHER||Adjusted response rate|81.1|||<|0.0001|TWO_SIDED|95.0|76.34|85.87|||z-test|A stratified one sample z-test with 50% reference for PegIFN-ineligible and 71% for PegIFN-eligible patients was performed.|The adjusted response rate was tested against the historical control SVR rate of 68% (95% Confidence Interval (CI): 76.3, 85.9).|The proportion of patients achieving SVR12 achieved with 24 weeks of treatment with DBV/FDV/RBV in cirrhotic and non-cirrhotic patients was compared to an acceptable minimum SVR rate achieved with an approved direct acting anti-viral (DAA) in combination with PegIFN from historical data. The acceptable minimum SVR rate was an average of 71% (reference for PegIFN-eligible) and 50% (for PegIFN-ineligible patients), weighted by the sample size in each stratum.||85.87|76.34|<0.0001
70941659|NCT04748445|141383934|OTHER||Slope|-0.2215|STANDARD_ERROR_OF_MEAN|8.498||0.0102|TWO_SIDED|90.0|-0.3624|-0.08072|||Mixed Models Analysis|||MM\_MFCC mean 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.08072|-0.3624|0.0102
71022594|NCT00323609|141553117|SUPERIORITY_OR_OTHER|||||||0.663||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at pre-discharge.||||0.663
71107449|NCT00565409|141721012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.02|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-1.4|-2.6|<0.0001
71107450|NCT00565409|141721012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.9048|TWO_SIDED|95.0|-0.5|0.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANOVA|||Week 48||0.6|-0.5|0.9048
71107451|NCT00565409|141721012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-1.5|-2.6|<0.0001
71107452|NCT00565409|141721012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-1.5|-2.6|<0.0001
71107453|NCT00565409|141721012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.8437|TWO_SIDED|95.0|-0.6|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||0.5|-0.6|0.8437
71107454|NCT00565409|141721012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-1.4|-2.6|<0.0001
71107455|NCT00565409|141721012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-1.4|-2.6|<0.0001
71107456|NCT00565409|141721012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.8587|TWO_SIDED|95.0|-0.6|0.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||0.7|-0.6|0.8587
71107457|NCT00565409|141721012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.03|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-1.4|-2.6|<0.0001
71107458|NCT00565409|141721012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.38|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-1.8|-3.0|<0.0001
71107459|NCT00565409|141721012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.6323|TWO_SIDED|95.0|-0.8|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||0.5|-0.8|0.6323
71107460|NCT00565409|141721012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.23|||<|0.0001|TWO_SIDED|95.0|-2.9|-1.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-1.6|-2.9|<0.0001
71107461|NCT00565409|141721012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.28|||<|0.0001|TWO_SIDED|95.0|-2.9|-1.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.6|-2.9|<0.0001
71107462|NCT00565409|141721012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.6558|TWO_SIDED|95.0|-0.8|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||0.5|-0.8|0.6558
71107463|NCT00565409|141721012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.14|||<|0.0001|TWO_SIDED|95.0|-2.8|-1.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.5|-2.8|<0.0001
71107464|NCT00565409|141721012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.41|||<|0.0001|TWO_SIDED|95.0|-3.1|-1.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-1.7|-3.1|<0.0001
71107465|NCT00565409|141721012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.8688|TWO_SIDED|95.0|-0.7|0.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||0.6|-0.7|0.8688
70933620|NCT01728324|141368410|SUPERIORITY_OR_OTHER||Adjusted response rate|75.89||||0.002|TWO_SIDED|95.0|70.63|81.14|||z-test|A stratified one sample z-test with 50% reference for PegIFN-ineligible and 71% for PegIFN-eligible patients was performed.||The proportion of patients achieving SVR12 achieved with 16 weeks of treatment of non-cirrhotic and 24 weeks of treatment of cirrhotic patients was compared to an acceptable minimum SVR rate achieved with an approved direct acting anti-viral (DAA) in combination with PegIFN from historical data. The acceptable minimum SVR rate was an average of 71% (reference for PegIFN-eligible) and 50% (for PegIFN-ineligible patients), weighted by the sample size in each stratum.||81.14|70.63|0.0020
71055885|NCT00205803|141616080|SUPERIORITY_OR_OTHER||Ratio|1.04|||||TWO_SIDED|95.0|0.76|1.44||||||Pertussis - Pertactin||1.44|0.76|
71055886|NCT01175031|141616152|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||signed-rank tests|||||||0.003
71055887|NCT00555360|141616156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|STANDARD_DEVIATION|2.0||0.975|TWO_SIDED|95.0|-4.62|4.77|||Regression, Logistic|||||4.77|-4.62|.975
71055888|NCT00555360|141616157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.87|STANDARD_DEVIATION|1.7||0.349|TWO_SIDED|95.0|-5.78|2.05|||Regression, Logistic|||||2.05|-5.78|.349
71055889|NCT00555360|141616158|SUPERIORITY_OR_OTHER||Difference in Percent|14.0|STANDARD_DEVIATION|6.0||0.007|TWO_SIDED|95.0|3.9|24.2|||Regression, Logistic|||||24.2|3.9|.007
71055890|NCT03301623|141616159|SUPERIORITY||Mean Difference (Net)|-0.69||||0.541|TWO_SIDED|95.0|-2.9|1.52|||Mixed Models Analysis|Test is on interaction term between time (pre/post intervention) and treatment group (CDSvsPEAT) dummy variables in the regression model.|The interaction term describes the effect of PEAT in the post period.|"Question: Which communication strategy used during the clinical encounter is more effective in reducing pain interference over time for patients with chronic pain who were taking opioids at baseline?~Regression model includes a fixed effect for time and an interaction effect between pre/post intervention and intervention arm dummy variables. Analysis is clustered at the participant level."||1.52|-2.9|.541
71055891|NCT03301623|141616160|SUPERIORITY||Odds Ratio (OR)|2.96||||0.019|TWO_SIDED|95.0|1.2|7.31|||Regression, Logistic|There were 69 providers with at least one CG-CAHPS response.|The interaction term describes the change in the PEAT group's scores in the post period.|"Question: Which communication strategy used during the clinical encounter is more effective in improving how satisfied patients feel over time after communicating with their physician about chronic pain treatment risks and benefits?~Regression model includes a fixed effect for time and an interaction effect between pre/post intervention and intervention arm dummy variables. Analysis is clustered at the PCP level."||7.31|1.20|.019
71055892|NCT03301623|141616161|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.719|TWO_SIDED|95.0|-2.73|1.88|||Mixed Models Analysis||The interaction term describes the effect of PEAT in the post period.|"Question: Which communication strategy used during the clinical encounter is more effective in improving physical function over time for patients with chronic pain who were taking opioids at baseline?~Regression model includes a fixed effect for time and an interaction effect between pre/post intervention and intervention arm dummy variables. Analysis is clustered at the participant level."||1.88|-2.73|.719
70851475|NCT05477108|141190941|EQUIVALENCE|For AUClast, the intra-participant CV% in Treatment B (reference arm) was 74.17. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.2735 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|102.02|||||TWO_SIDED|90.0|89.12|116.79|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Glycopyrronium Pharmacokinetic Parameters (US approach)||116.79|89.12|
71055893|NCT03301623|141616162|SUPERIORITY||Odds Ratio (OR)|1.63||||0.01|TWO_SIDED|95.0|1.13|2.36|||Mixed Models Analysis||The interaction term describes the effect of PEAT in the post period.|"Question: Which communication strategy used during the clinical encounter is more effective in reducing opioid prescriptions of more than 90 morphine milligrams equivalent (MME) over time for patients with chronic pain who were taking opioids at baseline?~Regression model includes a fixed effect for time and an interaction effect between pre/post intervention and intervention arm dummy variables. Analysis is clustered at the PCP level."||2.36|1.13|.010
71055894|NCT03301623|141616163|SUPERIORITY||Odds Ratio (OR)|0.76||||0.51|TWO_SIDED|95.0|0.34|1.71|||Mixed Models Analysis||The interaction term describes the effect of PEAT in the post period.|Question: Which communication strategy used during the clinical encounter is more effective in reducing co-prescription of opioids and benzodiazepines over time for patients with chronic pain who were taking opioids at baseline?||1.71|.34|.510
71055895|NCT03301623|141616164|SUPERIORITY||Odds Ratio (OR)|1.34||||0.26|TWO_SIDED|95.0|0.76|2.34|||Regression, Logistic|We employed robust standard errors clustered at the participant level. Time was controlled for using a fixed effect.|The interaction term describes the effect of PEAT in the post period.|PHQ-9 was categorized by assigning scores of 0, 1, 2, and 3 to the response categories (not at all: several days, more than half the days, nearly every day, respectively) and then summing. Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively. The analysis was conducted as a multilevel ordered logistic regression.||2.34|.76|.260
71107466|NCT00565409|141721012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-1.7|-3.0|<0.0001
71107467|NCT00565409|141721015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.5|-1.0|<0.0001
71107468|NCT00565409|141721015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9636|TWO_SIDED|95.0|-0.2|0.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||0.3|-0.2|0.9636
71107469|NCT00565409|141721015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.5|-1.0|<0.0001
70851476|NCT05477108|141190941|EQUIVALENCE|For AUClast, the intra-participant CV% in Treatment B (reference arm) was 66.88. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.2210 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|107.76|||||TWO_SIDED|90.0|94.91|122.36|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Formoterol Pharmacokinetic Parameters (US approach)||122.36|94.91|
70933621|NCT01728324|141368411|SUPERIORITY_OR_OTHER||SVR12 Rates difference|6.4||||0.0532|TWO_SIDED|95.0|-1.4|14.2|||Koch's method|Adjusted for PegIFN eligibility using Koch's method, with continuity correction.||Koch's stratum-adjusted Mantel Haenszel methods were used to compare durations, adjusting for stratification factors.||14.2|-1.4|0.0532
71107470|NCT00565409|141721015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-0.8|-1.4|<0.0001
71107471|NCT00565409|141721015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.4605|TWO_SIDED|95.0|-0.2|0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||0.4|-0.2|0.4605
71107472|NCT00565409|141721015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-0.9|-1.5|<0.0001
71107473|NCT00565409|141721015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-0.8|-1.4|<0.0001
71107474|NCT00565409|141721015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.8404|TWO_SIDED|95.0|-0.3|0.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||0.3|-0.3|0.8404
71022595|NCT00323609|141553117|SUPERIORITY_OR_OTHER|||||||0.933||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.933
71022596|NCT00323609|141553117|SUPERIORITY_OR_OTHER|||||||0.089||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.089
71022597|NCT00323609|141553117|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.036
71022598|NCT00323609|141553118|SUPERIORITY_OR_OTHER|||||||0.472||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at pre-discharge.||||0.472
71022599|NCT00323609|141553118|SUPERIORITY_OR_OTHER|||||||0.745||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.745
71022600|NCT00323609|141553118|SUPERIORITY_OR_OTHER|||||||0.565||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.565
71022601|NCT00323609|141553118|SUPERIORITY_OR_OTHER|||||||0.687||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.687
71022602|NCT00267293|141553123|NON_INFERIORITY_OR_EQUIVALENCE|Power for 80%|||||<|0.001||||||comparision of mean temperatures from repeated exposure. At hour 6 temperature|Mixed Models Analysis|||Power for 80%||||<0.001
71022603|NCT00267293|141553123|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Binary outcome \<38C and \>=38C|Chi-squared|||||||<.0001
71022604|NCT00950599|141553124|SUPERIORITY_OR_OTHER|||||||0.9888||95.0||||A significance level of alpha = 0.05 was used for the trend test.|Kruskal-Wallis|ANCOVA Model: post-pre=pre treatment.||A test for log-linear trend across saxagliptin doses was performed using a linear contrast among the saxagliptin doses from an analysis of covariance (ANCOVA) model. The ANCOVA model was the same model used for the first secondary endpoint.||||0.9888
71022605|NCT00950599|141553125|SUPERIORITY_OR_OTHER|||||||0.9888||95.0||||Positive efficacy trend among doses of saxagliptin by assessing the adjusted mean change from baseline in A1C in the 0-40 mg cohort.|ANCOVA|ANCOVA Model: post-pre=pretreatment. Contrast Coefficients: -2, -1, 0, 1 2.||||||0.9888
71022606|NCT03803085|141553230|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||||||0.02
71022607|NCT03803085|141553231|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
71022608|NCT03803085|141553232|SUPERIORITY|||||||0.06||||||p\<0.05 was considered significant.|Mixed Models Analysis|||||||0.06
70933622|NCT01728324|141368412|SUPERIORITY_OR_OTHER||SVR4 Rates difference|3.6||||0.1671|TWO_SIDED|95.0|-3.7|10.9|||Koch´s method|Adjusted for PegIFN eligibility using Koch´s method, with continuity correction.||Koch's stratum-adjusted Mantel Haenszel methods were used to compare durations, adjusting for stratification factors.||10.9|-3.7|0.1671
70933623|NCT01728324|141368413|SUPERIORITY_OR_OTHER||SVR24 Rates difference|-6.9||||0.0447|TWO_SIDED|95.0|-14.8|1.1|||Koch´s method|Adjusted for PegIFN eligibility using Koch´s method, with continuity correction.||Koch's stratum-adjusted Mantel Haenszel methods were used to compare durations, adjusting for stratification factors.||1.1|-14.8|0.0447
70933624|NCT01335867|141368415|SUPERIORITY|||||||0.14|||||||Chi-squared|||||||.14
70933625|NCT01335867|141368417|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||.24
71055896|NCT00658021|141616165|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.363||0.444|TWO_SIDED|95.0|-1.01|0.45|||Mixed Models Analysis|||Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline HbA1c, background diabetes therapy strata, week of visit, baseline HbA1c-by-visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix.||0.45|-1.01|0.444
71055897|NCT00658021|141616167|SUPERIORITY|||||||0.562|||||||Cochran-Mantel-Haenszel|||"Treatment difference in HbA1c \< 7% at Week 28:~Treatment group comparison is based on CMH test stratified by screening HbA1c and background diabetes therapy strata. P-value is from the general association statistics."||||0.562
71055898|NCT00658021|141616167|SUPERIORITY|||||||0.621|||||||Cochran-Mantel-Haenszel|||"Treatment difference in HbA1c \<= 6.5% at Week 28:~Treatment group comparison is based on CMH test stratified by screening HbA1c and background diabetes therapy strata. P-value is from the general association statistics."||||0.621
71055899|NCT00658021|141616167|SUPERIORITY|||||||0.229|||||||Cochran-Mantel-Haenszel|||"Treatment difference in HbA1c \< 6.5% at Week 28:~Treatment group comparison is based on CMH test stratified by screening HbA1c and background diabetes therapy strata. P-value is from the general association statistics."||||0.229
71055900|NCT00658021|141616168|SUPERIORITY||LS Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.327||0.005|TWO_SIDED|95.0|-1.58|-0.28|||Mixed Models Analysis|||"Treatment difference in body weight at Week 4:~Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline body weight, screening HbA1c strata, background diabetes therapy strata, week of visit, baseline body weight-by visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix."||-0.28|-1.58|0.005
71055901|NCT00658021|141616168|SUPERIORITY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.669||0.314|TWO_SIDED|95.0|-2.0|0.65|||Mixed Models Analysis|||"Treatment difference in body weight at Week 12:~Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline body weight, screening HbA1c strata, background diabetes therapy strata, week of visit, baseline body weight-by visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix."||0.65|-2.00|0.314
71107475|NCT00565409|141721015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-0.9|-1.4|<0.0001
70933626|NCT01335867|141368418|SUPERIORITY|||||||0.2|||||||Chi-squared|||||||.20
70933627|NCT01335867|141368419|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||||||.64
70933628|NCT03057600|141368420|SUPERIORITY|||||||0.2252|||||||exact one-sample binomial tests|||||||0.2252
70933629|NCT03057600|141368420|SUPERIORITY|||||||0.9437|||||||exact one-sample binomial tests|||||||0.9437
70933630|NCT03057600|141368420|SUPERIORITY|||||||0.5797|||||||exact one-sample binomial tests|||||||0.5797
70933631|NCT03057600|141368420|SUPERIORITY|||||||0.0243|||||||exact one-sample binomial tests|||||||0.0243
70933632|NCT03335488|141368445|SUPERIORITY||Odds Ratio (OR)|1.1||||1|TWO_SIDED|95.0|0.0|28.1|||Fisher Exact|||||28.1|0.0|1.0000
70933633|NCT03335488|141368447|SUPERIORITY|||||||0.8464|||||||Wilcoxon rank sum test|||Initial Treatment Period Week 1||||0.8464
70933634|NCT03335488|141368447|SUPERIORITY|||||||0.104|||||||Wilcoxon rank sum test|||Initial Treatment Period Week 2||||0.1040
70933635|NCT03335488|141368447|SUPERIORITY|||||||0.0979|||||||Wilcoxon rank sum test|||Initial Treatment Period Week 3||||0.0979
70933636|NCT03335488|141368447|SUPERIORITY|||||||0.9808|||||||Wilcoxon rank sum test|||End of Initial Treatment Period Week 4 - 0 Hr||||0.9808
70933637|NCT03335488|141368447|SUPERIORITY|||||||0.8329|||||||Wilcoxon rank sum test|||End of Initial Treatment Period Week 4 - 4 Hr||||0.8329
70933638|NCT03335488|141368447|SUPERIORITY|||||||0.2544|||||||Wilcoxon rank sum test|||End of Initial Treatment Period Week 4 - 8 Hr||||0.2544
71055902|NCT00658021|141616168|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.94||0.692|TWO_SIDED|95.0|-2.24|1.5|||Mixed Models Analysis|||"Treatment difference in body weight at Week 20:~Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline body weight, screening HbA1c strata, background diabetes therapy strata, week of visit, baseline body weight-by visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix."||1.50|-2.24|0.692
71055903|NCT00658021|141616168|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|1.065||0.679|TWO_SIDED|95.0|-2.56|1.68|||Mixed Models Analysis|||"Treatment difference in body weight at Week 28:~Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline body weight, screening HbA1c strata, background diabetes therapy strata, week of visit, baseline body weight-by visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix."||1.68|-2.56|0.679
71055904|NCT00658021|141616169|SUPERIORITY||LS Mean Difference|-0.281|STANDARD_ERROR_OF_MEAN|0.68||0.679|TWO_SIDED|95.0|-1.614|1.052|||ANCOVA|||Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline fasting serum glucose, screening HbA1c strata and background diabetes therapy strata as fixed effects.||1.052|-1.614|0.679
71107476|NCT00565409|141721015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-0.8|-1.4|<0.0001
71107477|NCT00565409|141721015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.3118|TWO_SIDED|95.0|-0.1|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||0.5|-0.1|0.3118
71107478|NCT00565409|141721015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-1.0|-1.6|<0.0001
71107479|NCT00565409|141721015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-0.9|-1.6|<0.0001
70933639|NCT03335488|141368448|SUPERIORITY|||||||0.8579||||||P-value is from a t-test comparing log-transformed RAVICTI vs NaPBA values.|t-test|||||||0.8579
71055905|NCT00658021|141616170|SUPERIORITY||LS Mean Difference|0.189|STANDARD_ERROR_OF_MEAN|0.5151||0.714|TWO_SIDED|95.0|-0.821|1.199|||ANCOVA|||Treatment difference for pre-meal SMBG: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline SMBG measure, screening HbA1c strata and background diabetes therapy strata as fixed effects.||1.199|-0.821|0.714
71055906|NCT00658021|141616170|SUPERIORITY||LS Mean Difference|0.513|STANDARD_ERROR_OF_MEAN|0.5245||0.329|TWO_SIDED|95.0|-0.516|1.541|||ANCOVA|||Treatment difference for post-meal SMBG: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline SMBG measure, screening HbA1c strata and background diabetes therapy strata as fixed effects.||1.541|-0.516|0.329
71055907|NCT00658021|141616170|SUPERIORITY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.4015||0.601|TWO_SIDED|95.0|-0.577|0.997|||ANCOVA|||Treatment difference for post-prandial excursion SMBG: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline SMBG measure, screening HbA1c strata and background diabetes therapy strata as fixed effects.||0.997|-0.577|0.601
71055908|NCT00658021|141616170|SUPERIORITY||LS Mean Difference|0.316|STANDARD_ERROR_OF_MEAN|0.4749||0.505|TWO_SIDED|95.0|-0.615|1.248|||ANCOVA|||Treatment difference for overall SMBG: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline SMBG measure, screening HbA1c strata and background diabetes therapy strata as fixed effects.||1.248|-0.615|0.505
71055909|NCT00658021|141616171|SUPERIORITY||LS Mean Difference|-10.82|STANDARD_ERROR_OF_MEAN|43.187||0.802|TWO_SIDED|95.0|-95.48|73.84|||ANCOVA|||Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline fasting serum insulin, screening HbA1c strata and background diabetes therapy strata as fixed effects.||73.84|-95.48|0.802
71055910|NCT00658021|141616172|SUPERIORITY||LS Mean Difference|-3.84|STANDARD_ERROR_OF_MEAN|18.542||0.836|TWO_SIDED|95.0|-40.19|32.51|||ANCOVA|||Treatment difference for HOMA-B: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline %HOMA-B, screening HbA1c strata and background diabetes therapy strata as fixed effects.||32.51|-40.19|0.836
71055911|NCT00658021|141616172|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|3.846||0.941|TWO_SIDED|95.0|-7.82|7.26|||ANCOVA|||Treatment difference for HOMA-S: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline %HOMA-S, screening HbA1c strata and background diabetes therapy strata as fixed effects.||7.26|-7.82|0.941
71055912|NCT02092467|141616175|NON_INFERIORITY|Hazard ratio (95% CI) was based on a univariate Cox proportional hazard model with treatment \[All Tofacitinib (ie, tofacitinib 5 mg BID and tofacitinib 10 mg BID combined) and TNFi\] as covariate.|Hazard Ratio (HR)|1.48|||||TWO_SIDED|95.0|1.04|2.09|||||Primary comparison. Non-inferiority was to be claimed between All Tofacitinib and TNFi if the upper limit of the 95% CI for HR was \< 1.8 (non-inferiority criterion).|All Tofacitinib versus TNFi||2.09|1.04|
71055913|NCT02092467|141616175|NON_INFERIORITY|Hazard ratio (95% CI) was based on a univariate cox proportional hazard model with treatment (tofacitinib 5 mg BID, tofacitinib 10 mg BID and TNFi) as covariate.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.7|1.43|||||Secondary comparison. Non-inferiority was to be claimed between tofacitinib 10 mg BID and tofacitinib 5 mg BID if the upper limit of the 95% CI for HR was \< 2.0 (non-inferiority criterion).|Tofacitinib 10 mg BID versus Tofacitinib 5 mg BID||1.43|0.70|
71055914|NCT02092467|141616175|OTHER|Hazard ratio (95% CI) was based on a univariate cox proportional hazard model with treatment (tofacitinib 5 mg BID, tofacitinib 10 mg BID and TNFi) as covariate.|Hazard Ratio (HR)|1.47|||||TWO_SIDED|95.0|1.0|2.18|||||Supportive analysis to the primary comparison between All Tofacitinib vs TNFi.|Tofacitinib 5 mg BID versus TNFi||2.18|1.00|
71107480|NCT00565409|141721015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.61|TWO_SIDED|95.0|-0.2|0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||0.4|-0.2|0.6100
71107481|NCT00565409|141721015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-1.0|-1.6|<0.0001
71107482|NCT00565409|141721015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.0|-1.6|<0.0001
71107483|NCT00565409|141721015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.6552|TWO_SIDED|95.0|-0.4|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||0.2|-0.4|0.6552
70933640|NCT03335488|141368449|SUPERIORITY|||||||0.7155||||||P-value is from a t-test comparing log-transformed RAVICTI vs NaPBA values.|t-test|||||||0.7155
71055915|NCT02092467|141616175|OTHER|Hazard ratio (95% CI) was based on a univariate cox proportional hazard model with treatment (tofacitinib 5 mg BID, tofacitinib 10 mg BID and TNFi) as covariate.|Hazard Ratio (HR)|1.48|||||TWO_SIDED|95.0|1.0|2.19|||||Supportive analysis to the primary comparison between All Tofacitinib vs TNFi.|Tofacitinib 10 mg BID versus TNFi||2.19|1.00|
70933641|NCT01953692|141368457|SUPERIORITY||||||>|0.9999||||||one-sided p value|exact binomial distribution|||Comparison to a fixed efficacy target of 10%. H0: p ≤ 0.10 versus H1: p \> 0.10||||>0.9999
71055916|NCT02092467|141616176|NON_INFERIORITY|Hazard ratio (95% CI) was based on a univariate Cox proportional hazard model with treatment \[All Tofacitinib (ie, tofacitinib 5 mg BID and tofacitinib 10 mg BID combined) and TNFi\] as covariate.|Hazard Ratio (HR)|1.33|||||TWO_SIDED|95.0|0.91|1.94|||||Primary comparison. Non-inferiority was to be claimed between All Tofacitinib and TNFi if the upper limit of the 95% CI for HR was \< 1.8 (non-inferiority criterion).|All Tofacitinib versus TNFi||1.94|0.91|
71055917|NCT02092467|141616176|NON_INFERIORITY|Hazard ratio (95% CI) was based on a univariate cox proportional hazard model with treatment (tofacitinib 5 mg BID, tofacitinib 10 mg BID and TNFi) as covariate.|Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.77|1.71|||||Secondary Comparison. Non-inferiority was to be claimed between tofacitinib 10 mg BID and tofacitinib 5 mg BID if the upper limit of the 95% CI for HR was \<2.0 (non-inferiority criterion).|Tofacitinib 10 mg BID versus Tofacitinib 5 mg BID||1.71|0.77|
71055918|NCT02092467|141616176|OTHER|Hazard ratio (95% CI) was based on a univariate cox proportional hazard model with treatment (tofacitinib 5 mg BID, tofacitinib 10 mg BID and TNFi) as covariate.|Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|0.81|1.91|||||Supportive analysis to the primary comparison between All Tofacitinib vs TNFi.|Tofacitinib 5 mg BID versus TNFi||1.91|0.81|
71055919|NCT02092467|141616176|OTHER|Hazard ratio (95% CI) was based on a univariate cox proportional hazard model with treatment (tofacitinib 5 mg BID, tofacitinib 10 mg BID and TNFi) as covariate.|Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|0.94|2.18|||||Supportive analysis to the primary comparison between All Tofacitinib vs TNFi.|Tofacitinib 10 mg BID versus TNFi||2.18|0.94|
71055920|NCT01595386|141616199|NON_INFERIORITY_OR_EQUIVALENCE|Study sample size was powered to detect a 60% difference in LCOS between groups at α 0.05 and β 0.70, assuming the prevalence of LCOS after neonatal bypass of 65% (based on retrospective data of patients who died, required rescue steroids, ECMO, or epinephrine \> 0.1 μg/kg/min).||||||0.049|TWO_SIDED|||||A p-value of \<0.05 represents the threshold for statistical significance.|t-test, 2 sided|||||||0.049
71055921|NCT01595386|141616200|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.44|TWO_SIDED|95.0|||||Chi-squared|||||||0.44
71055922|NCT01595386|141616201|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.62|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.62
71055923|NCT01595386|141616202|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic|||||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
71055924|NCT01595386|141616202|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic|||||<|0.01|TWO_SIDED|95.0||||interleukin-6 at 12, 24, and 48 hour. A p-value of \<0.05 is the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||<0.01
71107484|NCT00565409|141721015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.27|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.0|-1.6|<0.0001
70933642|NCT01953692|141368458|SUPERIORITY||||||>|0.9999||||||one-sided p-value|exact binomial distribution|||Comparison to a fixed efficacy target of 25%. H0: p ≤ 0.25 versus H1: p \> 0.25||||>0.9999
71055925|NCT01595386|141616202|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic|||||<|0.01|TWO_SIDED|95.0||||TNF-alpha at 12, 24, and 48 hours.A p-value of \<0.05 is the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||<0.01
71055926|NCT01595386|141616202|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic|||||<|0.05|TWO_SIDED|95.0||||Interleukin1-beta at 24 and 48 hours.A p-value of \<0.05 is the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||<0.05
71055927|NCT01595386|141616202|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic|||||<|0.05|TWO_SIDED|95.0||||Interleukin-8 at 24 and 48 hours.A p-value of \<0.05 is the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||<0.05
71055928|NCT01595386|141616202|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic||||||0.03|TWO_SIDED|95.0||||IL-10 at 4 hours.A p-value of \<0.05 is the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.03
71055929|NCT01595386|141616203|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.|||||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
71055930|NCT01595386|141616204|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.04|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.04
70933643|NCT01953692|141368459|SUPERIORITY|||||||0.0306||||||one-sided p-value|exact binomial distribution|||Comparison to a fixed efficacy target of 10%. H0: p ≤ 0.10 versus H1: p \> 0.10||||0.0306
71055931|NCT01595386|141616205|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.03|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
71055932|NCT01595386|141616206|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.7|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7
71055933|NCT01595386|141616207|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.76|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.76
71107485|NCT00565409|141721015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.43|||<|0.0001|TWO_SIDED|95.0|-1.8|-1.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-1.1|-1.8|<0.0001
71107486|NCT00565409|141721015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.4753|TWO_SIDED|95.0|-0.4|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||0.2|-0.4|0.4753
71022609|NCT01684722|141553243|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.25|TWO_SIDED|95.0|-0.7|2.5|||Mixed Models Analysis|||||2.5|-0.7|0.25
71055934|NCT01595386|141616208|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.23|TWO_SIDED|95.0|||||Fisher Exact|||||||0.23
71055935|NCT01595386|141616209|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.|||||<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||||||<0.05
71055936|NCT01595386|141616209|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic|||||<|0.001|TWO_SIDED|95.0||||post-operative cortisol.A p-value of \<0.05 is the threshold for statistical significance.|Fisher Exact|||||||<0.001
71055937|NCT01595386|141616209|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic||||||0.004|TWO_SIDED|95.0||||Adrenal Insufficiency after bypass.A p-value of \<0.05 is the threshold for statistical significance.|Fisher Exact|||||||0.004
71055938|NCT01595386|141616209|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic||||||0.02|TWO_SIDED|95.0||||Development of Low cardiac output syndrome in subjects with Adrenal Insufficiency.A p-value of \<0.05 is the threshold for statistical significance.|Fisher Exact|||||||0.02
71055939|NCT02952898|141616217|SUPERIORITY||||||<|0.0001|||||||Chi-squared, Corrected|||Two-sided, continuity-corrected Chi-square tests was used to evaluate the superiority of GDC 695 gel's complete clearance proportion over that of the Vehicle treatment in the mITT population using LOCF.||||<0.0001
71022610|NCT01684722|141553243|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.27|TWO_SIDED|95.0|-0.7|2.6|||Mixed Models Analysis|||||2.6|-0.7|0.27
71022611|NCT01684722|141553244|SUPERIORITY||Ratio of change from baseline, active to|0.99||||0.9|TWO_SIDED|95.0|0.84|1.17|||Mixed Models Analysis|||||1.17|0.84|0.90
71022612|NCT01684722|141553244|SUPERIORITY||Ratio of change from baseline, active to|0.96||||0.64|TWO_SIDED|95.0|0.81|1.14|||Mixed Models Analysis|||||1.14|0.81|0.64
71022613|NCT02345486|141553251|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.001|TWO_SIDED|95.0|0.66|0.74|||Wilcoxon (Mann-Whitney)||"reported mean difference is a difference in proportions."|||0.74|0.66|0.001
71022614|NCT03979677|141553286|OTHER|HDI and DHI analyzed using linear mixed-effects models with two within-participant factors, Intervention (pre-intervention, post-intervention) and Inventory (DHI, HDI). All models included participant as a random factor. Models constructed using lmer function of the lme package in R and analyzed using anova function in base R. Significant main effects and interactions were evaluated using emmeans . Pairwise comparisons were adjusted to account for false-discovery rates.|||||<|0.0001||||||Multiple comparisons were adjusted.|linear mixed-effects models|||||||<.0001
71022615|NCT03979677|141553287|OTHER|HDI and DHI analyzed using linear mixed-effects models with two within-participant factors, Intervention (pre-intervention, post-intervention) and Inventory (DHI, HDI). All models included participant as a random factor. Models constructed using lmer function of the lme package in R and analyzed using anova function in base R. Significant main effects and interactions were evaluated using emmeans . Pairwise comparisons were adjusted to account for false-discovery rates.|||||<|0.0001||||||Point change in DHI was tests.|linear mixed-effects models|||||||<.0001
71022616|NCT03063632|141553290|OTHER|||||||||||||||||Per Global Response Score used in Mycosis Fungoides and Sezary Syndrome, Response is assessed by the standard response criteria: Complete Response (CR), complete disappearance of all clinical evidence of disease where all categories (i.e., skin, lymph nodes, viscera, blood) have complete response/noninvolved; Partial Response (PR), regression of measurable disease; Stable Disease (SD), failure to attain CR, PR, or PD.|Simple statistics. Non-responders excluded from analysis.|||
71022617|NCT03063632|141553291|OTHER||||||||||||||||||Kaplan-Meier method|||
71022618|NCT03063632|141553292|OTHER|||||||||||||||||Progression is assessed by the standard response criteria used in Mycosis Fungoides and Sezary Syndrome (skin, lymph nodes, viscera, blood, global). Per Global Response Score, progression is defined as Progressive Disease (PD) in any category (i.e., skin, lymph nodes, viscera, blood).|Kaplan-Meier method|||
71022619|NCT03063632|141553293|OTHER||||||||||||||||||Kaplan-Meier method|||
71022620|NCT03063632|141553294|OTHER||||||||||||||||||Binomial distribution|||
71022621|NCT02741271|141553298|SUPERIORITY||LSM Difference|5.21|||<|0.001|TWO_SIDED|95.0|3.21|7.2|||cLDA with multiple imputation|Primary Analysis Method, using the constrained Longitudinal Data Analysis (cLDA) model for missing data|Between-Treatment Difference|||7.20|3.21|<0.001
71022622|NCT02741271|141553301|SUPERIORITY||LSM Difference|6.05|||<|0.001|TWO_SIDED|95.0|3.53|8.56|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 4 hr Post-Dose|||8.56|3.53|<0.001
71022623|NCT02741271|141553301|SUPERIORITY||LSM Difference|7.04|||<|0.001|TWO_SIDED|95.0|4.74|9.35|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 2 hr Post-Dose|||9.35|4.74|<0.001
71022624|NCT02741271|141553301|SUPERIORITY||LSM Difference|6.19|||<|0.001|TWO_SIDED|95.0|4.09|8.28|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 60 min Post-Dose|||8.28|4.09|<0.001
71022625|NCT02741271|141553301|SUPERIORITY||LSM Difference|6.89|||<|0.001|TWO_SIDED|95.0|5.1|8.67|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 30 min Post-Dose|||8.67|5.10|<0.001
71022626|NCT02741271|141553301|SUPERIORITY||LSM Difference|6.64|||<|0.001|TWO_SIDED|95.0|4.89|8.39|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 15 min Post-Dose|||8.39|4.89|<0.001
71022627|NCT02741271|141553301|SUPERIORITY||LSM Difference|4.2|||<|0.001|TWO_SIDED|95.0|2.5|5.91|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 5 min Post-Dose|||5.91|2.50|<0.001
71022628|NCT02741271|141553302|SUPERIORITY||LSM Difference|6.32|||<|0.001|TWO_SIDED|95.0|4.36|8.27|||cLDA|Secondary Outcome Measure on Day 1|Between-Treatment Difference at 4 hr Post-Dose|||8.27|4.36|<0.001
71022629|NCT02741271|141553302|SUPERIORITY||LSM Difference|3.33||||0.026|TWO_SIDED|95.0|0.41|6.26|||cLDA|Secondary Outcome Measure at Week 12|Between-Treatment Difference at 4 hr Post-Dose|||6.26|0.41|0.026
71022630|NCT02741271|141553303|SUPERIORITY||LSM Difference|1.63||||0.197|TWO_SIDED|95.0|-0.85|4.11|||cLDA|Secondary Outcome Measure|Between-Treatment Difference|||4.11|-0.85|0.197
70933644|NCT01953692|141368460|SUPERIORITY|||||||0.7696||||||one-sided p-value|exact binomial distribution|||Comparison to a fixed efficacy target of 25%. H0: p ≤ 0.25 versus H1: p \> 0.25||||0.7696
70933645|NCT02233998|141368529|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.234|STANDARD_ERROR_OF_MEAN|0.0162|<|0.001|TWO_SIDED|95.0|-0.266|-0.202||Per statistical analysis plan, Hochberg's method at significance level 0.05 was applied to jointly evaluate Whole Mouth Mean MGI at Wk 3 and Whole Mouth Mean PI at Wk 3 for both Listerine rinses vs control. Family-wise error controlled at 0.05.|ANCOVA|Terms included treatment with baseline whole mouth mean modified gingival index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.202|-0.266|<0.001
70941660|NCT04748445|141383934|OTHER||Slope|0.0556|STANDARD_ERROR_OF_MEAN|7.072||0.4332|TWO_SIDED|90.0|-0.06159|0.1728|||Mixed Models Analysis|||MM\_MFCC mean 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1728|-0.06159|0.4332
71022631|NCT02570165|141553313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|191.1|||||TWO_SIDED|95.0|101.07|284.26|||||The 95% Bayesian credible interval for the mean difference between batefenterol 37.5 µg dose and placebo (batefenterol 37.5 µg minus placebo) was estimated.|||284.26|101.07|
71022632|NCT02570165|141553313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|231.6|||||TWO_SIDED|95.0|149.31|310.02|||||The 95% Bayesian credible interval for differences between each individual batefenterol 75 µg dose and placebo was estimated.|||310.02|149.31|
70941661|NCT04748445|141383934|OTHER||Slope|0.01214|STANDARD_ERROR_OF_MEAN|6.19||0.8448|TWO_SIDED|90.0|-0.09044|0.1147|||Mixed Models Analysis|||MM\_MFCC mean 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1147|-0.09044|0.8448
71022633|NCT02570165|141553313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|261.8|||||TWO_SIDED|95.0|189.85|332.25|||||The 95% Bayesian credible interval for differences between each individual batefenterol 150 µg dose and placebo was estimated.|||332.25|189.85|
71022634|NCT02570165|141553313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|281.4|||||TWO_SIDED|95.0|212.35|351.3|||||The 95% Bayesian credible interval for differences between each individual batefenterol 300 µg dose and placebo was estimated.|||351.30|212.35|
71022635|NCT02570165|141553313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|292.8|||||TWO_SIDED|95.0|223.02|364.42|||||The 95% Bayesian credible interval for differences between each individual batefenterol 600 µg dose and placebo was estimated.|||364.42|223.02|
71022636|NCT02570165|141553314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|182.2|||||TWO_SIDED|95.0|99.8|264.6|||||The 95% confidence interval for the difference between 37.5 µg Batefenterol and Placebo was estimated.|||264.60|99.80|
71022637|NCT02570165|141553314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|196.6|||||TWO_SIDED|95.0|128.4|264.8|||||The 95% confidence interval for the difference between 75 µg Batefenterol and Placebo was estimated.|||264.80|128.40|
70851477|NCT05477108|141190941|EQUIVALENCE|For AUClast, the analysis was conducted using an analysis of variance including fixed effects for treatment, sequence, period and subject within sequence. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since the 90% CI for the geometric mean ratio were fully contained within the predefined equivalence limits of 80% to 125%.|Geometric Mean ratio (%)|106.1|||||TWO_SIDED|90.0|98.39|114.41|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Budesonide Pharmacokinetic Parameters (EU approach)||114.41|98.39|
70933646|NCT02233998|141368529|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.197|STANDARD_ERROR_OF_MEAN|0.0161|<|0.001|TWO_SIDED|95.0|-0.228|-0.165||Per statistical analysis plan, Hochberg's method at significance level 0.05 was applied to jointly evaluate Whole Mouth Mean MGI at Wk 3 and Whole Mouth Mean PI at Wk 3 for both Listerine rinses vs control. Family-wise error controlled at 0.05.|ANCOVA|Terms included treatment with baseline whole mouth mean modified gingival index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.165|-0.228|<0.001
70933647|NCT02233998|141368530|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.469|STANDARD_ERROR_OF_MEAN|0.0286|<|0.001|TWO_SIDED|95.0|-0.526|-0.413||Per statistical analysis plan, Hochberg's method at significance level 0.05 was applied to jointly evaluate Whole Mouth Mean MGI at Wk 3 and Whole Mouth Mean PI at Wk 3 for both Listerine rinses vs control. Family-wise error controlled at 0.05.|ANCOVA|Terms included treatment with baseline whole mouth mean plaque index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.413|-0.526|<0.001
70933648|NCT02233998|141368530|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.379|STANDARD_ERROR_OF_MEAN|0.0286|<|0.001|TWO_SIDED|95.0|-0.435|-0.322||Per statistical analysis plan, Hochberg's method at significance level 0.05 was applied to jointly evaluate Whole Mouth Mean MGI at Wk 3 and Whole Mouth Mean PI at Wk 3 for both Listerine rinses vs control. Family-wise error controlled at 0.05.|ANCOVA|Terms included treatment with baseline whole mouth mean plaque index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.322|-0.435|<0.001
70933649|NCT02233998|141368531|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.006|<|0.001|TWO_SIDED|95.0|-0.042|-0.019||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment with baseline whole mouth mean gingival bleeding index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.019|-0.042|<0.001
70933650|NCT02233998|141368531|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.026|STANDARD_ERROR_OF_MEAN|0.0059|<|0.001|TWO_SIDED|95.0|-0.038|-0.014||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment with baseline whole mouth mean gingival bleeding index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.014|-0.038|<0.001
70933651|NCT02233998|141368532|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|23.24|||<|0.001|TWO_SIDED|95.0|20.75|25.85||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||25.85|20.75|<0.001
70933652|NCT02233998|141368532|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|19.444|||<|0.001|TWO_SIDED|95.0|17.09|22.22||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||22.22|17.09|<0.001
70941662|NCT04748445|141383934|OTHER||Slope|-0.1106|STANDARD_ERROR_OF_MEAN|4.852||0.0244|TWO_SIDED|90.0|-0.191|-0.03016|||Mixed Models Analysis|||MM\_MFCC mean 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.03016|-0.1910|0.0244
71055940|NCT02952898|141616217|SUPERIORITY||||||<|0.0001|||||||Chi-squared, Corrected|||Two-sided, continuity-corrected Chi-square tests was used to evaluate the superiority of Diclofenac sodium gel's complete clearance proportion over that of the Vehicle treatment in the mITT population using LOCF.||||<0.0001
71055941|NCT04400682|141616224|EQUIVALENCE|0.80-1.25 margins for equivalence|Mean ratio|1.015||||0|TWO_SIDED|90.0|0.9897|1.041|||ANOVA||||Ln(AUClast) : 0.989- 1.0410|1.0410|0.9897|0.0000
71055942|NCT04400682|141616225|EQUIVALENCE|0.80 - 1.25 equivalence margin is required.|Mean ratio|1.0361||||0.0033|TWO_SIDED|90.0|0.9294|1.1551|||ANOVA||||Ln(Cmax) : 0.9294 - 1.1551|1.1551|0.9294|0.0033
71055943|NCT04400682|141616226|EQUIVALENCE|0.80 - 1.25 equivalence margin is not required.|Mean ratio|1.0108||||0|TWO_SIDED|90.0|0.9856|1.0366|||ANOVA||||Ln(Cmax) : 0.9856 - 1.0366|1.0366|0.9856|0.0000
71055944|NCT02293863|141616230|OTHER||Hazard Ratio (HR)|1.08||||0.605|TWO_SIDED|80.0|0.83|1.4|||Wilcoxon (Mann-Whitney)|||||1.40|0.83|0.6050
71055945|NCT02293863|141616230|OTHER||Hazard Ratio (HR)|1.13||||0.2028|TWO_SIDED|80.0|0.85|1.51|||Wilcoxon (Mann-Whitney)|||||1.51|0.85|0.2028
71055946|NCT02293863|141616232|OTHER||Difference in event rates|10.19||||0.1905|TWO_SIDED|80.0|-0.15|20.52|||Cochran-Mantel-Haenszel|||||20.52|-0.15|0.1905
71055947|NCT02293863|141616232|OTHER||Difference in event rates|7.91||||0.3168|TWO_SIDED|80.0|-2.64|18.47|||Cochran-Mantel-Haenszel|||||18.47|-2.64|0.3168
71055948|NCT02293863|141616233|OTHER||Difference in event rates|-7.92||||0.6043|TWO_SIDED|80.0|-27.5|11.66|||Cochran-Mantel-Haenszel|||||11.66|-27.50|0.6043
71055949|NCT02293863|141616233|OTHER||Difference in event rates|-14.58||||0.3865|TWO_SIDED|80.0|-36.13|6.97|||Cochran-Mantel-Haenszel|||||6.97|-36.13|0.3865
71055950|NCT02293863|141616234|OTHER||Difference in event rates|1.99||||0.5379|TWO_SIDED|80.0|-5.57|9.56|||Cochran-Mantel-Haenszel|||Day 14||9.56|-5.57|0.5379
71055951|NCT02293863|141616234|OTHER||Difference in event rates|4.97||||0.2189|TWO_SIDED|80.0|-3.12|13.05|||Cochran-Mantel-Haenszel|||Day 14||13.05|-3.12|0.2189
71055952|NCT02293863|141616234|OTHER||Difference in event rates|2.14||||0.6594|TWO_SIDED|80.0|-6.04|10.31|||Cochran-Mantel-Haenszel|||Day 30||10.31|-6.04|0.6594
70941663|NCT04748445|141383934|OTHER||Slope|-0.04884|STANDARD_ERROR_OF_MEAN|4.827||0.3136|TWO_SIDED|90.0|-0.1288|0.03115|||Mixed Models Analysis|||MM\_MFCC mean 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.03115|-0.1288|0.3136
71055953|NCT02293863|141616234|OTHER||Difference in event rates|3.54||||0.5013|TWO_SIDED|80.0|-5.24|12.31|||Cochran-Mantel-Haenszel|||Day 30||12.31|-5.24|0.5013
71055954|NCT02293863|141616234|OTHER||Difference in event rates|2.21||||0.6849|TWO_SIDED|80.0|-6.28|10.69|||Cochran-Mantel-Haenszel|||Day 60||10.69|-6.28|0.6849
71055955|NCT02293863|141616234|OTHER||Difference in event rates|1.68||||0.7633|TWO_SIDED|80.0|-7.38|10.74|||Cochran-Mantel-Haenszel|||Day 60||10.74|-7.38|0.7633
71055956|NCT02293863|141616235|OTHER||Mean Difference (Final Values)|-3.73||||0.2407|TWO_SIDED|80.0|-6.41|-1.06|||ANOVA|||||-1.06|-6.41|0.2407
71055957|NCT02293863|141616235|OTHER||Mean Difference (Final Values)|-0.7||||0.8339|TWO_SIDED|80.0|-3.49|2.1|||ANOVA|||||2.10|-3.49|0.8339
71055958|NCT02293863|141616236|OTHER||Mean Difference (Final Values)|-0.33||||0.279|TWO_SIDED|80.0|-0.6|-0.07|||ANOVA|||||-0.07|-0.60|0.2790
71055959|NCT02293863|141616236|OTHER||Mean Difference (Final Values)|-0.42||||0.1909|TWO_SIDED|80.0|-0.7|-0.15|||ANOVA|||||-0.15|-0.70|0.1909
71055960|NCT02293863|141616237|OTHER||Hazard Ratio (HR)|1.01||||0.7413|TWO_SIDED|80.0|0.77|1.32|||Wilcoxon (Mann-Whitney)|||||1.32|0.77|0.7413
71055961|NCT02293863|141616237|OTHER||Hazard Ratio (HR)|1.32||||0.4763|TWO_SIDED|80.0|0.99|1.77|||Wilcoxon (Mann-Whitney)|||||1.77|0.99|0.4763
71055962|NCT02293863|141616238|OTHER||Hazard Ratio (HR)|1.01||||0.8806|TWO_SIDED|80.0|0.78|1.32|||Wilcoxon (Mann-Whitney)|||||1.32|0.78|0.8806
71055963|NCT02293863|141616238|OTHER||Hazard Ratio (HR)|1.05||||0.5447|TWO_SIDED|80.0|0.8|1.38|||Wilcoxon (Mann-Whitney)|||||1.38|0.80|0.5447
71055964|NCT02293863|141616239|OTHER||Hazard Ratio (HR)|0.7||||0.4171|TWO_SIDED|80.0|0.47|1.03|||Wilcoxon (Mann-Whitney)|||||1.03|0.47|0.4171
71055965|NCT02293863|141616239|OTHER||Hazard Ratio (HR)|0.9||||0.8322|TWO_SIDED|80.0|0.61|1.34|||Wilcoxon (Mann-Whitney)|||||1.34|0.61|0.8322
71055966|NCT02293863|141616240|OTHER||Difference in event rates|-1.42||||0.824|TWO_SIDED|80.0|-10.61|7.76|||Cochran-Mantel-Haenszel|||||7.76|-10.61|0.8240
71055967|NCT02293863|141616240|OTHER||Difference in event rates|-1.6||||0.8111|TWO_SIDED|80.0|-11.48|8.28|||Cochran-Mantel-Haenszel|||||8.28|-11.48|0.8111
71055968|NCT02293863|141616241|OTHER||Difference in event rates|2.42||||0.7219|TWO_SIDED|80.0|-6.96|11.8|||Cochran-Mantel-Haenszel|||||11.80|-6.96|0.7219
71055969|NCT02293863|141616241|OTHER||Difference in event rates|0.67||||0.9225|TWO_SIDED|80.0|-9.29|10.64|||Cochran-Mantel-Haenszel|||||10.64|-9.29|0.9225
71055970|NCT02293863|141616242|OTHER||Difference in event rates|1.99||||0.5379|TWO_SIDED|80.0|-5.57|9.56|||Cochran-Mantel-Haenszel|||||9.56|-5.57|0.5379
71055971|NCT02293863|141616242|OTHER||Difference in event rates|-1.85||||0.3667|TWO_SIDED|80.0|-9.88|6.18|||Cochran-Mantel-Haenszel|||||6.18|-9.88|0.3667
71055972|NCT02293863|141616243|OTHER||Hazard Ratio (HR)|0.66||||0.7827|TWO_SIDED|80.0|0.41|1.07|||Wilcoxon (Mann-Whitney)|||||1.07|0.41|0.7827
71055973|NCT02293863|141616243|OTHER||Hazard Ratio (HR)|0.58||||0.2522|TWO_SIDED|80.0|0.36|0.96|||Wilcoxon (Mann-Whitney)|||||0.96|0.36|0.2522
71055974|NCT03462459|141616249|EQUIVALENCE|Proportional tests (Chi-squared) compared the episodes of C. difficile. Log-rank tests (Kaplan-Meier) were conducted to compare the non-recurrence proportions within the eight-week period. Multivariate Cox proportional hazard regression determined if treatment, age, and number of previous C. difficile episodes were predictors of recurrence.|See comments|-0.11||||0.22|TWO_SIDED|95.0|-35.1|8.0|||Chi-squared||Proportional tests compared episodes of C. difficile recurrence in eight weeks (vancomycin vs. placebo) using Chi-squared test. Log-rank tests compared the non-recurrence proportions within 8 weeks with the Kaplan-Meier method.||"Statistical analyses are primarily reported for the population who were randomized in the study (as randomized). The secondary statistical analyses are reported for the population who completed all three visits (as completed treatment). Proportional tests were conducted to compare the episodes of C. difficile recurrence in eight weeks following the completion of the study intervention in patients receiving vancomycin versus placebo using the Chi-squared test. Log-rank tests were conducted to compare the non-recurrence proportions within the eight-week period in patients receiving vancomycin versus placebo with the Kaplan-Meier method. A nonparametric Wilcoxon rank sum test was used to compare distributions of the number of days to the first recurrence of CDI after starting oral vancomycin or placebo. The significance level was set to be ≤0.05. All statistical analyses were conducted in R statistical software (version 4.4.0; R Core Team, 2024)"|8.0|-35.1|0.22
71055975|NCT03462459|141616251|EQUIVALENCE|Proportional difference tests comparing the proportion of patients with VRE colonization at Visit 3, compared to baseline. Significance level was set to 0.10.||||||0.1|||||||Proportional difference test|||||||0.10
71055976|NCT03452137|141616291|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.6804|TWO_SIDED|95.0|0.7|1.26|||Log Rank||HR was estimated by Cox regression.|Stratified Analysis: The stratification factors were response to definitive local therapy, human papillomavirus (HPV) status and type of definitive local therapy as per interactive voice or web-based response system (IxRS).||1.26|0.70|0.6804
71055977|NCT03452137|141616292|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.8371|TWO_SIDED|95.0|0.68|1.36|||Log Rank||HR was estimated by Cox regression.|Stratified Analysis: The stratification factors were response to definitive local therapy, HPV status and type of definitive local therapy as per interactive voice or web-based response system (IxRS).||1.36|0.68|0.8371
71055978|NCT03452137|141616293|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.9115|TWO_SIDED|95.0|0.73|1.32|||Log Rank||HR was estimated by Cox regression|Stratified Analysis: The stratification factors were response to definitive local therapy, HPV status and type of definitive local therapy as per interactive voice or web-based response system (IxRS).||1.32|0.73|0.9115
71055979|NCT03452137|141616294|SUPERIORITY||Difference in Event Free Rate|-0.67||||0.8816|TWO_SIDED|95.0|-9.45|8.11|||Z test|||Difference in EFS Event-Free Rates at 1 year||8.11|-9.45|0.8816
71055980|NCT03452137|141616294|SUPERIORITY||Difference in Event Free Rate|0.46||||0.9234|TWO_SIDED|95.0|-8.86|9.78|||Z test|||Difference in EFS Event-Free Rates at 2 years||9.78|-8.86|0.9234
71055981|NCT03452137|141616294|SUPERIORITY||Difference in Event Free Rate|1.19||||0.809|TWO_SIDED|95.0|-8.49|10.88|||Z test|||Difference in EFS Event-Free Rates at 3 years||10.88|-8.49|0.8090
71055982|NCT03452137|141616294|SUPERIORITY||Difference in Event Free Rate|0.01||||0.9985|TWO_SIDED|95.0|-10.17|10.19|||Z test|||Difference in EFS Event-Free Rates at 4 years||10.19|-10.17|0.9985
70933653|NCT02233998|141368533|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|19.048|||<|0.001|TWO_SIDED|95.0|15.94|21.73||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||21.73|15.94|<0.001
70933654|NCT02233998|141368533|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|15.939|||<|0.001|TWO_SIDED|95.0|12.5|18.67||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||18.67|12.50|<0.001
71055983|NCT03452137|141616295|SUPERIORITY||Difference in Event Free Rate|5.17||||0.2393|TWO_SIDED|95.0|-3.44|13.79|||Z test|||Difference in EFS Event-Free Rates at 1 year||13.79|-3.44|0.2393
71055984|NCT03452137|141616295|SUPERIORITY||Difference in Event Free Rate|3.61||||0.4472|TWO_SIDED|95.0|-5.69|12.9|||Z test|||Difference in EFS Event-Free Rates at 2 years||12.90|-5.69|0.4472
71055985|NCT03452137|141616295|SUPERIORITY||Difference in Event Free Rate|3.14||||0.5222|TWO_SIDED|95.0|-6.49|12.77|||Z test|||Difference in EFS Event-Free Rates at 3 years||12.77|-6.49|0.5222
71055986|NCT03452137|141616295|SUPERIORITY||Difference in Event Free Rate|1.31||||0.7967|TWO_SIDED|95.0|-8.64|11.26|||Z test|||Difference in EFS Event-Free Rates at 4 years||11.26|-8.64|0.7967
71055987|NCT03452137|141616296|SUPERIORITY||Difference in Event Free Rate|2.77||||0.4819|TWO_SIDED|95.0|-4.95|10.49|||Z test|||Difference in OS Event-Free Rates at 2 years||10.49|-4.95|0.4819
71055988|NCT03452137|141616296|SUPERIORITY||Difference in Event Free Rate|-1.25||||0.7783|TWO_SIDED|95.0|-9.97|7.47|||Z test|||Difference in OS Event-Free Rates at 3 years||7.47|-9.97|0.7783
71055989|NCT03452137|141616296|SUPERIORITY||Difference in Event Free Rate|-1.07||||0.8924|TWO_SIDED|95.0|-16.56|14.42|||Z test|||Difference in OS Event-Free Rates at 5 years||14.42|-16.56|0.8924
71055990|NCT00261443|141616302|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.544||||0.014|TWO_SIDED|95.0|0.332|0.893||Stratified Log-rank Test, controlling for type of mood stabilizer and type of mood episode|Stratified Log-rank Test||Cox proportional hazards model, with type of mood stabilizer and type of index mood episode as stratification factors, and treatment group as covariate.|||0.893|0.332|0.014
71055991|NCT00261443|141616303|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.01||||0.911|TWO_SIDED|95.0|-0.16|0.15||ANOVA model, controlling for treatment, mood stabilizer, and index mood episode used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value used for mean change from baseline.|ANOVA/ANCOVA|Means, difference in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Baseline Comparison||0.15|-0.16|0.911
71055992|NCT00261443|141616303|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.04||||0.557|TWO_SIDED|95.0|-0.09|0.18||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.18|-0.09|0.557
71055993|NCT00261443|141616303|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.04||||0.596|TWO_SIDED|95.0|-0.18|0.1||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.10|-0.18|0.596
71055994|NCT00261443|141616303|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.05||||0.522|TWO_SIDED|95.0|-0.22|0.11||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.11|-0.22|0.522
71055995|NCT00261443|141616303|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.13||||0.142|TWO_SIDED|95.0|-0.3|0.04||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.04|-0.30|0.142
71055996|NCT00261443|141616303|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.16||||0.092|TWO_SIDED|95.0|-0.35|0.03||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.03|-0.35|0.092
71055997|NCT00261443|141616303|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.2||||0.039|TWO_SIDED|95.0|-0.4|-0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||-0.01|-0.40|0.039
70851478|NCT05477108|141190941|EQUIVALENCE|For AUClast, the analysis was conducted using an analysis of variance including fixed effects for treatment, sequence, period and subject within sequence. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since the 90% CI for the geometric mean ratio were fully contained within the predefined equivalence limits of 80% to 125%.|Geometric Mean Ratio (%)|97.02|||||TWO_SIDED|90.0|84.18|111.82|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Glycopyrronium Pharmacokinetic Parameters (EU approach)||111.82|84.18|
70851479|NCT05477108|141190941|EQUIVALENCE|For AUClast, the analysis was conducted using an analysis of variance including fixed effects for treatment, sequence, period and subject within sequence. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since the 90% CI for the geometric mean ratio were fully contained within the predefined equivalence limits of 80% to 125%.|Geometric Mean Ratio (%)|105.74|||||TWO_SIDED|90.0|92.59|120.75|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Formoterol Pharmacokinetic Parameters (EU approach)||120.75|92.59|
70933655|NCT02233998|141368534|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|2.05|||<|0.001|TWO_SIDED|95.0|1.3|2.78||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||2.78|1.30|<0.001
70933656|NCT02233998|141368534|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|1.19|||<|0.001|TWO_SIDED|95.0|0.93|2.06||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||2.06|0.93|<0.001
71055998|NCT00261443|141616303|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.21||||0.05|TWO_SIDED|95.0|-0.43|0.0||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||0.00|-0.43|0.050
71055999|NCT00261443|141616303|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.19||||0.064|TWO_SIDED|95.0|-0.4|0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||0.01|-0.40|0.064
70933657|NCT02233998|141368535|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|1.316||||0.016|TWO_SIDED|95.0|0.0|2.78||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||2.78|0.00|0.016
70933658|NCT02233998|141368535|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|0.926||||0.197|TWO_SIDED|95.0|-0.16|1.85||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||1.85|-0.16|0.197
71056000|NCT00261443|141616303|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.25||||0.017|TWO_SIDED|95.0|-0.46|-0.05||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||-0.05|-0.46|0.017
71056001|NCT00261443|141616303|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.22||||0.039|TWO_SIDED|95.0|-0.43|-0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||-0.01|-0.43|0.039
71056002|NCT00261443|141616303|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.27||||0.015|TWO_SIDED|95.0|-0.48|-0.05||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||-0.05|-0.48|0.015
71056003|NCT00261443|141616303|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.009|TWO_SIDED|95.0|-0.5|-0.07||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||-0.07|-0.50|0.009
71056004|NCT00261443|141616303|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.28||||0.013|TWO_SIDED|95.0|-0.5|-0.06||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||-0.06|-0.50|0.013
71056005|NCT00261443|141616304|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.348||||0.013|TWO_SIDED|95.0|0.146|0.829||Stratified Log-rank Test, controlling for type of mood stabilizer and type of index mood episode.|Stratified Log-rank Test||Cox proportional hazards model, with type of mood stabilizer and type of index mood episode as stratification factors, and treatment group as covariate.|||0.829|0.146|0.013
71107487|NCT00565409|141721015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-1.0|-1.6|<0.0001
71107488|NCT00565409|141721018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.6|-1.2|<0.0001
71107489|NCT00565409|141721018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.7427|TWO_SIDED|95.0|-0.4|0.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||0.3|-0.4|0.7427
71107490|NCT00565409|141721018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.5|-1.1|<0.0001
71107491|NCT00565409|141721018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.7|-1.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-1.1|-1.7|<0.0001
71107492|NCT00565409|141721018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.3129|TWO_SIDED|95.0|-0.5|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||0.2|-0.5|0.3129
71107493|NCT00565409|141721018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.23|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-0.9|-1.6|<0.0001
71107494|NCT00565409|141721018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-0.9|-1.6|<0.0001
71107495|NCT00565409|141721018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.4645|TWO_SIDED|95.0|-0.5|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||0.2|-0.5|0.4645
71107496|NCT00565409|141721018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-0.8|-1.5|<0.0001
71107497|NCT00565409|141721018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-0.9|-1.7|<0.0001
71107498|NCT00565409|141721018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.3793|TWO_SIDED|95.0|-0.5|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||0.2|-0.5|0.3793
71107499|NCT00565409|141721018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-0.8|-1.5|<0.0001
70933659|NCT02233998|141368536|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|23.214|||<|0.001|TWO_SIDED|95.0|18.21|28.77||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||28.77|18.21|<0.001
70933660|NCT02233998|141368536|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|18.59|||<|0.001|TWO_SIDED|95.0|13.69|23.81||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||23.81|13.69|<0.001
71107500|NCT00565409|141721018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.0|-1.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-1.2|-2.0|<0.0001
71107501|NCT00565409|141721018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.0816|TWO_SIDED|95.0|-0.7|0.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||0.0|-0.7|0.0816
71107502|NCT00565409|141721018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-0.9|-1.6|<0.0001
71107503|NCT00565409|141721018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|||<|0.0001|TWO_SIDED|95.0|-1.9|-1.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.2|-1.9|<0.0001
70851480|NCT02660983|141190949|SUPERIORITY||Difference in least square (LS) means|-0.58||||0.3455|TWO_SIDED|95.0|-1.79|0.63|||ANCOVA|||||0.63|-1.79|0.3455
71056006|NCT00261443|141616305|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.733||||0.384|TWO_SIDED|95.0|0.364|1.479||Stratified Log-rank Test P-value for Equality of Survival Curves|Stratified Log-rank Test||Cox proportional hazards model, with type of mood stabilizer and type of index mood episode as stratification factors, and treatment group as covariate.|||1.479|0.364|0.384
71056007|NCT00261443|141616307|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.02||||0.955|TWO_SIDED|95.0|-0.73|0.77||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Baseline Comparison||0.77|-0.73|0.955
71056008|NCT00261443|141616307|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.06||||0.895|TWO_SIDED|95.0|-0.83|0.95||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.95|-0.83|0.895
71022638|NCT02570165|141553314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|204.6|||||TWO_SIDED|95.0|137.2|272.1|||||The 95% confidence interval for the difference between 150 µg Batefenterol and Placebo was estimated.|||272.10|137.20|
71022639|NCT02570165|141553314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|208.9|||||TWO_SIDED|95.0|138.7|279.2|||||The 95% confidence interval for the difference between 300 µg Batefenterol and Placebo was estimated.|||279.20|138.70|
71022640|NCT02570165|141553314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|211.1|||||TWO_SIDED|95.0|138.6|283.7|||||The 95% confidence interval for the difference between 600 µg Batefenterol and Placebo was estimated.|||283.70|138.60|
71022641|NCT05478603|141553324|OTHER||Ratio of adjusted geometric means|94.88|||||TWO_SIDED|90.0|70.86|127.04|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||127.04|70.86|
71022642|NCT05478603|141553324|OTHER||Ratio of adjusted geometric means|99.75|||||TWO_SIDED|90.0|74.5|133.56|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||133.56|74.50|
71022643|NCT05478603|141553324|OTHER||Ratio of adjusted geometric means|68.7|||||TWO_SIDED|90.0|51.31|91.98|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||91.98|51.31|
71022644|NCT05478603|141553325|OTHER||Ratio of adjusted geometric means|101.87|||||TWO_SIDED|90.0|59.74|173.71|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||173.71|59.74|
71022645|NCT05478603|141553325|OTHER||Ratio of adjusted geometric means|156.07|||||TWO_SIDED|90.0|91.53|266.14|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||266.14|91.53|
71022646|NCT05478603|141553325|OTHER||Ratio of adjusted geometric means|96.48|||||TWO_SIDED|90.0|56.58|164.51|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||164.51|56.58|
71022647|NCT05478603|141553326|OTHER||Ratio of adjusted geometric means|102.21|||||TWO_SIDED|90.0|59.91|174.39|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||174.39|59.91|
71022648|NCT05478603|141553326|OTHER||Ratio of adjusted geometric means|152.91|||||TWO_SIDED|90.0|89.62|260.9|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||260.90|89.62|
71022649|NCT05478603|141553326|OTHER||Ratio of adjusted geometric means|97.08|||||TWO_SIDED|90.0|56.9|165.65|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||165.65|56.90|
71107504|NCT00565409|141721018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.0256|TWO_SIDED|95.0|-0.8|-0.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-0.1|-0.8|0.0256
71107505|NCT00565409|141721018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-0.8|-1.5|<0.0001
70851481|NCT02660983|141190950|SUPERIORITY||Difference in LS means|-0.12||||0.257|TWO_SIDED|95.0|-0.32|0.09|||ANCOVA||LS mean of Donepezil group - LS mean of Placebo (when the difference of LS mean scores were less than 0, considered as demonstrated hypothesis), analyzed with ANCOVA model with baseline (CIBIS) as covariate and treatment as main effect.|||0.09|-0.32|0.2570
71107506|NCT00565409|141721018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|||<|0.0001|TWO_SIDED|95.0|-1.9|-1.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-1.2|-1.9|<0.0001
70851482|NCT02660983|141190951|SUPERIORITY||Difference in LS means|0.65||||0.0396|TWO_SIDED|95.0|0.03|1.26|||ANCOVA|||||1.26|0.03|0.0396
70851483|NCT02660983|141190952|SUPERIORITY||Difference in LS means|-7.73||||0.2213|TWO_SIDED|95.0|-20.13|4.68|||ANCOVA|||Part A||4.68|-20.13|0.2213
70933661|NCT02233998|141368537|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|19.048|||<|0.001|TWO_SIDED|95.0|15.94|21.73||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||21.73|15.94|<0.001
70933662|NCT02233998|141368537|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|15.939|||<|0.001|TWO_SIDED|95.0|12.5|18.67||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||18.67|12.50|<0.001
70933663|NCT00853593|141368549|SUPERIORITY_OR_OTHER||One sample proportion|0.951|||||ONE_SIDED|95.0|0.906||||||The Model 4396 lead will be considered safe if the proportion of subjects free of Model 4396 lead-related complications at one month post-implant is greater than 80% (i.e. the one sided 95% lower confidence bound must be at least 80%).||||.906|
71107507|NCT00565409|141721018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.1158|TWO_SIDED|95.0|-0.7|0.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||0.1|-0.7|0.1158
70851484|NCT02660983|141190952|SUPERIORITY||Difference in LS means|-14.88||||0.0551|TWO_SIDED|95.0|-30.1|0.33|||ANCOVA|||Part B||0.33|-30.10|0.0551
70851485|NCT03376295|141190957|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.9|1.2|||Cox proportional hazards model||The hazard ratio (HR) is adjusted HR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score.|The Cox proportional hazard regression model was used to perform for moderate/severe exacerbation that assesses the effect of current use of LABA-TIO combination versus the LABA-ICS combination on the risk of a first COPD exacerbation.||1.20|0.90|
70851486|NCT03376295|141190957|OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.65|1.36|||Cox proportional hazards model||HR presented is adjusted HR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score.|The Cox proportional hazard regression model was used to perform for severe exacerbation that assesses the effect of current use of LABA-TIO combination versus the LABA-ICS combination on the risk of a first COPD exacerbation.||1.36|0.65|
70933664|NCT00853593|141368550|SUPERIORITY_OR_OTHER||One sample mean|1.6|STANDARD_DEVIATION|1.4|||ONE_SIDED|95.0||1.8||||||||1.8||
70933665|NCT00853593|141368551|SUPERIORITY_OR_OTHER||One sample mean|2.3|STANDARD_DEVIATION|2.0|||ONE_SIDED|97.5||2.7||||||||2.7||
70851487|NCT03376295|141190958|OTHER||Rate ratio (RR)|1.07|||||TWO_SIDED|95.0|0.92|1.25|||Negative binomial model||The rate ratio (RR) (LABA-TIO combination versus the LABA-ICS combination) is adjusted RR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score.|Moderate/severe exacerbation||1.25|0.92|
70933666|NCT00853593|141368552|SUPERIORITY_OR_OTHER||One sample proportion|0.927|||||TWO_SIDED|95.0|0.887|0.967||||||||.967|.887|
70933667|NCT00853593|141368553|SUPERIORITY_OR_OTHER||One sample proportion|0.969|||||TWO_SIDED|95.0|0.944|0.993||||||||.993|.944|
70933668|NCT00853593|141368554|SUPERIORITY_OR_OTHER||One sample proportion|0.959|||||TWO_SIDED|95.0|0.93|0.987||||||||.987|.930|
70933669|NCT00853593|141368555|SUPERIORITY_OR_OTHER||One sample proportion|0.948|||||TWO_SIDED|95.0|0.917|0.979||||||||.979|.917|
70933670|NCT00853593|141368561|SUPERIORITY_OR_OTHER||One sample mean|2.4|STANDARD_DEVIATION|1.9|||ONE_SIDED|95.0||2.7||||||||2.7||
71107508|NCT00565409|141721018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-0.9|-1.6|<0.0001
71107509|NCT00565409|141721021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.67||||0.0214|TWO_SIDED|95.0|-77.1|-6.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-6.2|-77.1|0.0214
71107510|NCT00565409|141721021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.57||||0.5544|TWO_SIDED|95.0|-45.6|24.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||24.5|-45.6|0.5544
71107511|NCT00565409|141721021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.1||||0.0826|TWO_SIDED|95.0|-66.2|4.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||4.0|-66.2|0.0826
70933671|NCT05966155|141368578|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.677|TWO_SIDED|95.0|-1.54|1.0|||t-test, 2 sided|||||1.00|-1.54|0.677
70933672|NCT05966155|141368579|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.1264|TWO_SIDED|95.0|-1.4|0.2|||t-test, 2 sided|||||0.2|-1.4|0.1264
71056009|NCT00261443|141616307|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.69||||0.144|TWO_SIDED|95.0|-1.61|0.24||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.24|-1.61|0.144
71056010|NCT00261443|141616307|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.1||||0.047|TWO_SIDED|95.0|-2.19|-0.01||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||-0.01|-2.19|0.047
71056011|NCT00261443|141616307|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.39||||0.017|TWO_SIDED|95.0|-2.52|-0.25||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||-0.25|-2.52|0.017
71056012|NCT00261443|141616307|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.91||||0.003|TWO_SIDED|95.0|-3.15|-0.68||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||-0.68|-3.15|0.003
71056013|NCT00261443|141616307|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.18|||<|0.001|TWO_SIDED|95.0|-3.47|-0.89||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||-0.89|-3.47|<0.001
71056014|NCT00261443|141616307|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.62|||<|0.001|TWO_SIDED|95.0|-4.06|-1.19||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||-1.19|-4.06|<0.001
71056015|NCT00261443|141616307|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.33|||<|0.001|TWO_SIDED|95.0|-3.7|-0.95||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||-0.95|-3.70|<0.001
71056016|NCT00261443|141616307|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.78|||<|0.001|TWO_SIDED|95.0|-4.19|-1.37||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||-1.37|-4.19|<0.001
71056017|NCT00261443|141616307|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.71|||<|0.001|TWO_SIDED|95.0|-4.13|-1.29||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||-1.29|-4.13|<0.001
71056018|NCT00261443|141616307|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.92|||<|0.001|TWO_SIDED|95.0|-4.38|-1.46||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||-1.46|-4.38|<0.001
71056019|NCT00261443|141616307|SUPERIORITY_OR_OTHER_LEGACY||Difference|-3.08|||<|0.001|TWO_SIDED|95.0|-4.59|-1.57||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||-1.57|-4.59|<0.001
70933673|NCT05966155|141368580|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.3692|TWO_SIDED|95.0|-0.4|1.1|||t-test, 2 sided||The by-group means and the estimated mean difference are independently rounded to the nearest tenth. As a result, the mean difference it not exactly equivalent to the difference in the two reported means.|||1.1|-0.4|0.3692
70933674|NCT05966155|141368581|SUPERIORITY|||||||0.8492|||||||Chi-squared|||||||0.8492
70933675|NCT05966155|141368582|SUPERIORITY|||||||0.0246|||||||Chi-squared|||||||0.0246
70933676|NCT05966155|141368583|SUPERIORITY|||||||0.0111|||||||Chi-squared|||||||0.0111
70933677|NCT05966155|141368584|SUPERIORITY|||||||0.0776|||||||Chi-squared|||||||0.0776
70933678|NCT05966155|141368585|SUPERIORITY|||||||0.0014|||||||Chi-squared|||||||0.0014
71107512|NCT00565409|141721021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-80.05||||0.0001|TWO_SIDED|95.0|-120.3|-39.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-39.8|-120.3|0.0001
71107513|NCT00565409|141721021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.18||||0.0344|TWO_SIDED|95.0|-83.2|-3.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-3.2|-83.2|0.0344
71107514|NCT00565409|141721021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.87||||0.0721|TWO_SIDED|95.0|-77.1|3.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||3.3|-77.1|0.0721
71107515|NCT00565409|141721021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-89.19|||<|0.0001|TWO_SIDED|95.0|-128.7|-49.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-49.7|-128.7|<0.0001
70933679|NCT04119063|141368592|OTHER|Paired t-tests comparing change in % difference following high vs low frequency gait training.||||||0.204|||||||t-test, 2 sided|||||||0.204
71056020|NCT00261443|141616307|SUPERIORITY_OR_OTHER_LEGACY||Difference|-3.04|||<|0.001|TWO_SIDED|95.0|-4.55|-1.54||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||-1.54|-4.55|<0.001
71056021|NCT00261443|141616309|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.2||||0.59|TWO_SIDED|95.0|-0.54|0.94||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Baseline Comparison||0.94|-0.54|0.590
71107516|NCT00565409|141721021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.14||||0.191|TWO_SIDED|95.0|-65.4|13.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||13.1|-65.4|0.1910
70933680|NCT04119063|141368593|OTHER|Paired t-test||||||0.049|||||||t-test, 2 sided|||||||0.049
71056022|NCT00261443|141616309|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.5||||0.371|TWO_SIDED|95.0|-1.59|0.6||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.60|-1.59|0.371
71056023|NCT00261443|141616309|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.04||||0.113|TWO_SIDED|95.0|-2.33|0.25||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.25|-2.33|0.113
71056024|NCT00261443|141616309|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.0||||0.128|TWO_SIDED|95.0|-2.28|0.29||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.29|-2.28|0.128
71056025|NCT00261443|141616309|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.85||||0.205|TWO_SIDED|95.0|-2.16|0.47||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.47|-2.16|0.205
71056026|NCT00261443|141616309|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.13||||0.125|TWO_SIDED|95.0|-2.59|0.32||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.32|-2.59|0.125
71107517|NCT00565409|141721021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-63.05||||0.0018|TWO_SIDED|95.0|-102.5|-23.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-23.6|-102.5|0.0018
70933681|NCT04119063|141368594|OTHER|Paired t-tests comparing change in % difference following high vs low frequency gait training.||||||0.039|||||||t-test, 2 sided|||||||0.039
70933682|NCT04119063|141368595|OTHER|Paired t-tests comparing change in % difference following high vs low frequency gait training.||||||0.242|||||||t-test, 2 sided|||||||0.242
70933683|NCT04119063|141368596|OTHER|Paired t-tests comparing change in % difference following high vs low frequency gait training.||||||0.014|||||||t-test, 2 sided|||||||.014
71107518|NCT00565409|141721021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-84.36||||0.0002|TWO_SIDED|95.0|-129.1|-39.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-39.6|-129.1|0.0002
71107519|NCT00565409|141721021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.85||||0.935|TWO_SIDED|95.0|-46.3|42.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||42.6|-46.3|0.9350
71107520|NCT00565409|141721021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-82.52||||0.0003|TWO_SIDED|95.0|-127.2|-37.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-37.8|-127.2|0.0003
70851488|NCT03376295|141190958|OTHER||Rate ratio (RR)|0.85|||||TWO_SIDED|95.0|0.55|1.33|||Negative binomial model||The RR (LABA-TIO combination versus the LABA-ICS combination) is adjusted RR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score.|Severe exacerbation||1.33|0.55|
70851489|NCT03376295|141190959|OTHER||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.42|1.05|||Cox proportional hazards model||The HR is adjusted HR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score|The cox proportional hazard regression model was used to perform an as-treated analysis that assesses the effect of current use of LABA-TIO combination versus the LABA-ICS combination on the risk of a first COPD exacerbation.||1.05|0.42|
70851490|NCT03376295|141190959|OTHER||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.48|0.92|||Cox proportional hazards model||The HR is adjusted HR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score|The Cox proportional hazard regression model was used to perform an on-treatment analysis that assesses the effect of current use of LABA-TIO combination versus the LABA-ICS combination on the risk of a first COPD exacerbation.||0.92|0.48|
70851491|NCT04303195|141190960|SUPERIORITY||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.479||0.135|TWO_SIDED|95.0|-1.67|0.23||The threshold for statistical significance was p = 0.05.|ANOVA|||||0.23|-1.67|0.1350
70933684|NCT03102034|141368627|OTHER||% vaccine recipients with solicited AEs|76.0|||||TWO_SIDED|90.0|56.0|90.0|||||Confidence intervals were Exact Clopper-Pearson.|||90|56|
71056027|NCT00261443|141616309|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.43||||0.061|TWO_SIDED|95.0|-2.92|0.06||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||0.06|-2.92|0.061
70851492|NCT04303195|141190960|SUPERIORITY||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.493||0.0997|TWO_SIDED|95.0|-1.79|0.16||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.16|-1.79|0.0997
71056028|NCT00261443|141616309|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.51||||0.06|TWO_SIDED|95.0|-3.07|0.06||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||0.06|-3.07|0.060
71056029|NCT00261443|141616309|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.62||||0.046|TWO_SIDED|95.0|-3.21|-0.03||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||-0.03|-3.21|0.046
71056030|NCT00261443|141616309|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.15||||0.164|TWO_SIDED|95.0|-2.77|0.47||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||0.47|-2.77|0.164
71056031|NCT00261443|141616309|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.53||||0.066|TWO_SIDED|95.0|-3.16|0.1||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||0.10|-3.16|0.066
71107521|NCT00565409|141721021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-108.73|||<|0.0001|TWO_SIDED|95.0|-157.0|-60.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-60.4|-157.0|<0.0001
70851493|NCT04303195|141190960|SUPERIORITY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.492||0.2195|TWO_SIDED|95.0|-1.58|0.37||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.37|-1.58|0.2195
70851494|NCT04303195|141190961|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.498||0.7944|TWO_SIDED|95.0|-1.11|0.85||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.85|-1.11|0.7944
70851495|NCT04303195|141190961|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.51||0.4956|TWO_SIDED|95.0|-1.36|0.66||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.66|-1.36|0.4956
70933685|NCT03102034|141368627|OTHER||% placebo recipients with solicited AEs|18.0|||||TWO_SIDED|90.0|3.0|47.0|||||Confidence intervals were Exact Clopper-Pearson.|||47|3|
70933686|NCT03102034|141368628|OTHER||% vaccinees with unsolicited AEs|24.0|||||TWO_SIDED|90.0|10.0|44.0|||||Confidence intervals were Exact Clopper-Pearson.|||44|10|
70933687|NCT03102034|141368628|OTHER||% placebo with unsolicited AEs|9.0|||||TWO_SIDED|90.0|0.0|36.0|||||Confidence intervals were Exact Clopper-Pearson.|||36|0|
70851496|NCT04303195|141190961|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.511||0.626|TWO_SIDED|95.0|-0.76|1.26||The threshold for statistical significance was p = 0.05.|ANCOVA|||||1.26|-0.76|0.6260
70851497|NCT04303195|141190962|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.543||0.8866|TWO_SIDED|95.0|-1.15|1.0||The threshold for statistical significance was p = 0.05.|ANCOVA|||||1.00|-1.15|0.8866
70851498|NCT04303195|141190962|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.558||0.8699|TWO_SIDED|95.0|-1.19|1.01||The threshold for statistical significance was p = 0.05.|ANCOVA|||||1.01|-1.19|0.8699
70933688|NCT03102034|141368633|SUPERIORITY||||||<|0.001||||||Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Fisher Exact|||||||<0.001
70933689|NCT03102034|141368634|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance is 0.05.|Log Rank|||||||<0.001
70933690|NCT02222493|141368639|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence test|Proportion Difference|-2.39|||||TWO_SIDED|95.0|-9.92|5.11||||||Score statistic method||5.11|-9.92|
71107522|NCT00565409|141721021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.2||||0.6764|TWO_SIDED|95.0|-58.2|37.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||37.8|-58.2|0.6764
71107523|NCT00565409|141721021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-98.53|||<|0.0001|TWO_SIDED|95.0|-146.7|-50.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-50.3|-146.7|<0.0001
71107524|NCT00565409|141721021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-115.48|||<|0.0001|TWO_SIDED|95.0|-157.7|-73.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-73.3|-157.7|<0.0001
71107525|NCT00565409|141721021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.69||||0.5219|TWO_SIDED|95.0|-55.6|28.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||28.3|-55.6|0.5219
71107526|NCT00565409|141721021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-101.8|||<|0.0001|TWO_SIDED|95.0|-144.0|-59.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-59.6|-144.0|<0.0001
71107527|NCT00565409|141721021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-71.6||||0.002|TWO_SIDED|95.0|-116.9|-26.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-26.3|-116.9|0.0020
71107528|NCT00565409|141721021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.3||||0.5917|TWO_SIDED|95.0|-32.7|57.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||57.3|-32.7|0.5917
71107529|NCT00565409|141721021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-83.91||||0.0003|TWO_SIDED|95.0|-129.2|-38.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-38.7|-129.2|0.0003
71107530|NCT00565409|141721024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.79|||<|0.0001|TWO_SIDED|95.0|-11.9|-5.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-5.7|-11.9|<0.0001
70933691|NCT02222493|141368639|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence test|Proportion Difference|-2.39|||||TWO_SIDED|90.0|-8.75|4.02||||||Score statistic method||4.02|-8.75|
70933692|NCT01701401|141368737|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF 12 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
70851499|NCT04303195|141190962|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.556||0.7297|TWO_SIDED|95.0|-0.91|1.29||The threshold for statistical significance was p = 0.05.|ANCOVA|||||1.29|-0.91|0.7297
70933693|NCT01701401|141368737|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF+RBV 12 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
70933694|NCT01701401|141368737|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF 24 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
70933695|NCT01701401|141368737|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF+RBV 24 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
70933696|NCT01000805|141368834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|||<|0.001|TWO_SIDED|95.0|-0.9|-0.33||This p-value is for the main effect of treatment.|Mixed Models Analysis|||||-0.33|-0.90|<0.001
70933697|NCT01000805|141368835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.04|||<|0.001|TWO_SIDED|95.0|-5.83|-2.24|||Mixed Models Analysis|||||-2.24|-5.83|<0.001
70933698|NCT01000805|141368836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.112|TWO_SIDED|95.0|-1.03|0.11||This is the p-value for the Disrupt Work/School Work score.|Mixed Models Analysis|||||0.11|-1.03|0.112
70933699|NCT01000805|141368836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73||||0.005|TWO_SIDED|95.0|-1.24|-0.22||This the p-value for the Disrupt Social Life/Leisure score.|Mixed Models Analysis|||||-0.22|-1.24|0.005
71107531|NCT00565409|141721024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.55||||0.1033|TWO_SIDED|95.0|-5.6|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||0.5|-5.6|0.1033
71107532|NCT00565409|141721024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.23|||<|0.0001|TWO_SIDED|95.0|-9.3|-3.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-3.1|-9.3|<0.0001
71107533|NCT00565409|141721024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.09|||<|0.0001|TWO_SIDED|95.0|-15.4|-8.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-8.8|-15.4|<0.0001
70933700|NCT01000805|141368836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.04|TWO_SIDED|95.0|-1.04|-0.02||This is the p-value for the Disrupt Family Life/Home score.|Mixed Models Analysis|||||-0.02|-1.04|0.040
70933701|NCT01000805|141368836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75||||0.019|TWO_SIDED|95.0|-3.2|-0.29||P-value for the SDS Total score. First gated secondary outcome measure. Gatekeeper strategy controlled experiment-wise type I error for 5 secondary outcomes with stepwise comparisons of treatments until outcome failed to be significant (p\>0.05).|Mixed Models Analysis|||||-0.29|-3.20|0.019
71107534|NCT00565409|141721024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.6802|TWO_SIDED|95.0|-4.0|2.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||2.6|-4.0|0.6802
71107535|NCT00565409|141721024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.39|||<|0.0001|TWO_SIDED|95.0|-14.7|-8.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-8.1|-14.7|<0.0001
71107536|NCT00565409|141721024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.09|||<|0.0001|TWO_SIDED|95.0|-15.6|-8.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-8.6|-15.6|<0.0001
71107537|NCT00565409|141721024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36||||0.4404|TWO_SIDED|95.0|-4.8|2.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||2.1|-4.8|0.4404
71107538|NCT00565409|141721024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.73|||<|0.0001|TWO_SIDED|95.0|-14.2|-7.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-7.2|-14.2|<0.0001
71107539|NCT00565409|141721024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.83|||<|0.0001|TWO_SIDED|95.0|-16.2|-9.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-9.4|-16.2|<0.0001
70933702|NCT01000805|141368837|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||This is the second gated secondary outcome measure. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|Cochran-Mantel-Haenszel|||||||0.001
70933703|NCT01000805|141368838|SUPERIORITY_OR_OTHER|||||||0.0082||95.0||||This is the third gated secondary outcome measure. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|Cochran-Mantel-Haenszel|||||||0.0082
71107540|NCT00565409|141721024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32||||0.4437|TWO_SIDED|95.0|-4.7|2.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||2.1|-4.7|0.4437
71107541|NCT00565409|141721024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.51|||<|0.0001|TWO_SIDED|95.0|-14.9|-8.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-8.1|-14.9|<0.0001
71107542|NCT00565409|141721024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.79|||<|0.0001|TWO_SIDED|95.0|-18.5|-11.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-11.1|-18.5|<0.0001
71107543|NCT00565409|141721024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.12||||0.096|TWO_SIDED|95.0|-6.8|0.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||0.6|-6.8|0.0960
71107544|NCT00565409|141721024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.67|||<|0.0001|TWO_SIDED|95.0|-15.4|-8.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-8.0|-15.4|<0.0001
71107545|NCT00565409|141721024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.56|||<|0.0001|TWO_SIDED|95.0|-18.1|-11.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-11.0|-18.1|<0.0001
71107546|NCT00565409|141721024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88||||0.2948|TWO_SIDED|95.0|-5.4|1.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||1.6|-5.4|0.2948
71107547|NCT00565409|141721024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.68|||<|0.0001|TWO_SIDED|95.0|-16.2|-9.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-9.1|-16.2|<0.0001
71107548|NCT00565409|141721024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.16|||<|0.0001|TWO_SIDED|95.0|-16.9|-9.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-9.5|-16.9|<0.0001
71107549|NCT00565409|141721024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33||||0.213|TWO_SIDED|95.0|-6.0|1.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||1.3|-6.0|0.2130
70851500|NCT04303195|141190963|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.409||0.9034|TWO_SIDED|95.0|-0.76|0.86||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.86|-0.76|0.9034
71107550|NCT00565409|141721024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.83|||<|0.0001|TWO_SIDED|95.0|-14.5|-7.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-7.1|-14.5|<0.0001
71107551|NCT00565409|141721027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.55|||<|0.0001|TWO_SIDED|95.0|-11.8|-5.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-5.3|-11.8|<0.0001
70933704|NCT01000805|141368839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.66|||<|0.001|TWO_SIDED|95.0|-5.2|-2.11||This is the fourth gated secondary outcome measure. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|Mixed Models Analysis|||||-2.11|-5.20|<0.001
70933705|NCT01000805|141368840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.19||||0.001|TWO_SIDED|95.0|-3.5|-0.89||This is the fifth gated secondary outcome measure. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|Mixed Models Analysis|||||-0.89|-3.50|0.001
70933706|NCT01000805|141368841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|||<|0.001|TWO_SIDED|95.0|-0.97|-0.32||This is the p-value for the main effect of treatment for the BPI Severity for Worst Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.32|-0.97|<0.001
71107552|NCT00565409|141721027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.8033|TWO_SIDED|95.0|-3.6|2.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||2.8|-3.6|0.8033
71107553|NCT00565409|141721027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.14|||<|0.0001|TWO_SIDED|95.0|-11.3|-4.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-4.9|-11.3|<0.0001
71107554|NCT00565409|141721027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.61|||<|0.0001|TWO_SIDED|95.0|-17.2|-10.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-10.0|-17.2|<0.0001
70851501|NCT04303195|141190963|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.33||0.9742|TWO_SIDED|95.0|-0.68|0.63||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.63|-0.68|0.9742
70933707|NCT01000805|141368841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|||<|0.001|TWO_SIDED|95.0|-0.9|-0.34||This is the p-value for main effect of treatment for the BPI Severity for Least Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.34|-0.90|<0.001
70933708|NCT01000805|141368841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|||<|0.001|TWO_SIDED|95.0|-0.9|-0.33||This is the p-value for the main effect of treatment for the BPI Severity for Average Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.33|-0.90|<0.001
71056032|NCT00261443|141616309|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.57||||0.066|TWO_SIDED|95.0|-3.24|0.1||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||0.10|-3.24|0.066
71056033|NCT00261443|141616309|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.08||||0.014|TWO_SIDED|95.0|-3.73|-0.43||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||-0.43|-3.73|0.014
71056034|NCT00261443|141616309|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.01||||0.019|TWO_SIDED|95.0|-3.68|-0.34||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||-0.34|-3.68|0.019
71056035|NCT00261443|141616311|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.05||||0.597|TWO_SIDED|95.0|-0.13|0.22||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Baseline Comparison||0.22|-0.13|0.597
71056036|NCT00261443|141616311|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.02||||0.838|TWO_SIDED|95.0|-0.17|0.21||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.21|-0.17|0.838
71056037|NCT00261443|141616311|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.11||||0.291|TWO_SIDED|95.0|-0.32|0.1||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.10|-0.32|0.291
71056038|NCT00261443|141616311|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.14||||0.219|TWO_SIDED|95.0|-0.37|0.08||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.08|-0.37|0.219
71056039|NCT00261443|141616311|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.18||||0.133|TWO_SIDED|95.0|-0.41|0.05||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.05|-0.41|0.133
71056040|NCT00261443|141616311|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.21||||0.092|TWO_SIDED|95.0|-0.46|0.04||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.04|-0.46|0.092
71056041|NCT00261443|141616311|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.31||||0.018|TWO_SIDED|95.0|-0.56|-0.05||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||-0.05|-0.56|0.018
71056042|NCT00261443|141616311|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.029|TWO_SIDED|95.0|-0.56|-0.03||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||-0.03|-0.56|0.029
71056043|NCT00261443|141616311|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.31||||0.024|TWO_SIDED|95.0|-0.57|-0.04||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||-0.04|-0.57|0.024
70851502|NCT04303195|141190963|SUPERIORITY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.417||0.2235|TWO_SIDED|95.0|-0.31|1.33||The threshold for statistical significance was p = 0.05.|ANCOVA|||||1.33|-0.31|0.2235
70851503|NCT04303195|141190964|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.118||0.3567|TWO_SIDED|95.0|-0.34|0.12||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.12|-0.34|0.3567
70851504|NCT04303195|141190964|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.12||0.1129|TWO_SIDED|95.0|-0.43|0.05||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.05|-0.43|0.1129
71056044|NCT00261443|141616311|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.035|TWO_SIDED|95.0|-0.56|-0.02||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||-0.02|-0.56|0.035
70851505|NCT04303195|141190964|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.12||0.459|TWO_SIDED|95.0|-0.33|0.15||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.15|-0.33|0.4590
70851506|NCT04303195|141190965|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.485||0.525|TWO_SIDED|95.0|-1.27|0.65||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.65|-1.27|0.5250
70851507|NCT04303195|141190965|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.498||0.3991|TWO_SIDED|95.0|-1.41|0.56||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.56|-1.41|0.3991
70851508|NCT04303195|141190965|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.497||0.9006|TWO_SIDED|95.0|-1.05|0.92||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.92|-1.05|0.9006
70851509|NCT04303195|141190966|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.444||0.6009|TWO_SIDED|95.0|-1.11|0.64||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.64|-1.11|0.6009
70851510|NCT04303195|141190966|SUPERIORITY||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.454||0.4654|TWO_SIDED|95.0|-1.23|0.56||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.56|-1.23|0.4654
71056045|NCT00261443|141616311|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.038|TWO_SIDED|95.0|-0.56|-0.02||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||-0.02|-0.56|0.038
71056046|NCT00261443|141616311|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.34||||0.015|TWO_SIDED|95.0|-0.62|-0.07||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||-0.07|-0.62|0.015
71056047|NCT00261443|141616311|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.39||||0.006|TWO_SIDED|95.0|-0.67|-0.12||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||-0.12|-0.67|0.006
71056048|NCT00261443|141616311|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.35||||0.015|TWO_SIDED|95.0|-0.62|-0.07||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||-0.07|-0.62|0.015
71056049|NCT00261443|141616313|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.04||||0.588|TWO_SIDED|95.0|-0.09|0.16||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Baseline Comparison||0.16|-0.09|0.588
71107555|NCT00565409|141721027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.783|TWO_SIDED|95.0|-4.1|3.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||3.1|-4.1|0.7830
70851511|NCT04303195|141190966|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.455||0.8842|TWO_SIDED|95.0|-0.83|0.97||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.97|-0.83|0.8842
70851512|NCT01065454|141190967|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-2.71||||0.1044|TWO_SIDED|95.0|-5.99|0.057||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA|||||0.057|-5.99|0.1044
70851513|NCT01065454|141190967|SUPERIORITY_OR_OTHER_LEGACY||LSMEANS Difference|-1.38||||0.5292|TWO_SIDED|95.0|-5.71|2.94||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA|||||2.94|-5.71|0.5292
70851514|NCT01065454|141190967|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-4.51||||0.0278|TWO_SIDED|95.0|-8.52|-0.5||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA|||||-0.50|-8.52|0.0278
70851515|NCT01065454|141190967|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|1.8||||0.3821|TWO_SIDED|95.0|-2.25|5.84||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA|||||5.84|-2.25|0.3821
70851516|NCT01065454|141190967|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|3.13||||0.2084|TWO_SIDED|95.0|-1.76|8.02||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA|||||8.02|-1.76|0.2084
70851517|NCT01065454|141190967|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-1.33||||0.5442|TWO_SIDED|95.0|-5.66|3.0||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA|||||3.00|-5.66|0.5442
70851518|NCT01065454|141190968|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|1.87|||||TWO_SIDED|95.0|-0.83|4.56||||||||4.56|-0.83|
70851519|NCT01065454|141190968|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.2|||||TWO_SIDED|95.0|-3.12|3.51||||||||3.51|-3.12|
70851520|NCT01065454|141190968|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.23|||||TWO_SIDED|95.0|-3.31|3.77||||||||3.77|-3.31|
70851521|NCT01065454|141190969|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-46.59|||||TWO_SIDED|95.0|-89.4|-3.8||||||||-3.8|-89.4|
70851522|NCT01065454|141190969|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-32.26|||||TWO_SIDED|95.0|-84.9|20.4||||||||20.4|-84.9|
70933709|NCT01000805|141368841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|||<|0.001|TWO_SIDED|95.0|-1.06|-0.42||This is the p-value for the main effect of treatment for the BPI Severity for Pain Right Now score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.42|-1.06|<0.001
70933710|NCT01000805|141368841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|||<|0.001|TWO_SIDED|95.0|-1.03|-0.33||This is the p-value for the main effect of treatment for the BPI Pain Interference with General Activity score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.33|-1.03|<0.001
70933711|NCT01000805|141368841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|||<|0.001|TWO_SIDED|95.0|-1.09|-0.37||This is the p-value for the main effect of treatment for the BPI Pain Interference with Mood score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.37|-1.09|<0.001
70933712|NCT01000805|141368841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.009|TWO_SIDED|95.0|-0.79|-0.11||This is the p-value for the main effect of treatment for the BPI Pain Interference with Walking Ability score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.11|-0.79|0.009
70933713|NCT01000805|141368841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.002|TWO_SIDED|95.0|-0.91|-0.21||This is the p-value for the main effect of treatment for the BPI Pain Interference with Normal Work score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.21|-0.91|0.002
70933714|NCT01000805|141368841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.06|-0.35||This is the p-value for the main effect of treatment for the BPI Pain Interference with Relations with Others score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.35|-1.06|<0.001
70933715|NCT01000805|141368841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.042|TWO_SIDED|95.0|-0.76|-0.01||This is the p-value for the main effect of treatment for the BPI Pain Interference with Sleep score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.01|-0.76|0.042
70933716|NCT01000805|141368841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|||<|0.001|TWO_SIDED|95.0|-1.03|-0.31||This is the p-value for the main effect of treatment for the BPI Pain Interference with Enjoyment of Life score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.31|-1.03|<0.001
71056050|NCT00261443|141616313|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.01||||0.922|TWO_SIDED|95.0|-0.18|0.16||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.16|-0.18|0.922
71056051|NCT00261443|141616313|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.11||||0.266|TWO_SIDED|95.0|-0.3|0.08||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.08|-0.30|0.266
70933717|NCT01000805|141368841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.001|TWO_SIDED|95.0|-0.88|-0.25||This is the p-value for the main effect of treatment for the BPI Mean Pain Interference score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.25|-0.88|<0.001
70933718|NCT01000805|141368842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|||<|0.001|TWO_SIDED|95.0|-0.71|-0.26||P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.26|-0.71|<0.001
70933719|NCT01000805|141368843|SUPERIORITY_OR_OTHER|||||||0.293||95.0||||This is the p-value for suicidal ideation. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.293
70933720|NCT01000805|141368844|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.033
70933721|NCT01000805|141368845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.92|||<|0.001|TWO_SIDED|95.0|1.34|4.51||This is the p-value for the Change from Baseline at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||4.51|1.34|<0.001
70933722|NCT01000805|141368845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4||||0.001|TWO_SIDED|95.0|0.97|3.83||This is the p-value for the Change up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||3.83|0.97|0.001
70933723|NCT01000805|141368846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9||||0.083|TWO_SIDED|95.0|-0.25|4.04||This is the p-value for the Change from Baseline in SBP at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||4.04|-0.25|0.083
70933724|NCT01000805|141368846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.513|TWO_SIDED|95.0|-0.95|1.9||This is the p-value for the Change from Baseline in DBP at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||1.90|-0.95|0.513
70933725|NCT01000805|141368846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.53||||0.124|TWO_SIDED|95.0|-0.42|3.47||This is the p-value for the Change from Baseline in SBP up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||3.47|-0.42|0.124
70933726|NCT01000805|141368846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.638|TWO_SIDED|95.0|-0.98|1.6||This is the p-value for the Change from Baseline in DBP up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||1.60|-0.98|0.638
70933727|NCT01000805|141368847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|||<|0.001|TWO_SIDED|95.0|-1.37|-0.54||This is the p-value for the Change from Baseline at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.54|-1.37|<0.001
70933728|NCT01000805|141368847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|||<|0.001|TWO_SIDED|95.0|-1.24|-0.51||This is the p-value for the Change from Baseline up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||-0.51|-1.24|<0.001
70933729|NCT00989196|141368848|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For the comparison of the PK profile of Human-cl rhFVIII with Kogenate, the 90% confidence intervals for the ratio or log-ratio of Human-cl rhFVIII over Kogenate for selected, dose independent or dose adjusted, PK parameters will be presented. In addition a formal statistical procedure will test whether the ratio of mean AUCs is within a 80 to 125% range to show bioequivalence.|Ratio|0.98|||||TWO_SIDED|90.0|0.874|1.107||||||||1.107|0.874|
70933730|NCT02409680|141368857|SUPERIORITY||Risk Ratio (RR)|0.89||||0.012|TWO_SIDED|95.0|0.81|0.98||A-priori threshold for statistical significance at 0.05 was specified.|Cochran-Mantel-Haenszel|||The null hypothesis is there is no treatment effect on preterm delivery.||0.98|0.81|0.012
70851523|NCT01065454|141190969|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-26.52|||||TWO_SIDED|95.0|-83.0|30.0||||||||30.0|-83.0|
70933731|NCT02409680|141368858|SUPERIORITY||Risk Ratio (RR)|1.08||||0.299|TWO_SIDED|95.0|0.94|1.25|||Cochran-Mantel-Haenszel|||||1.25|0.94|0.299
70851524|NCT01065454|141190970|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-89.17|||||TWO_SIDED|95.0|-172.9|5.5||||||||5.5|-172.9|
70851525|NCT01065454|141190970|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-58.22|||||TWO_SIDED|95.0|-162.1|45.6||||||||45.6|-162.1|
70851526|NCT01065454|141190970|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-43.22|||||TWO_SIDED|95.0|-153.7|67.1||||||||67.1|-153.7|
70933732|NCT02409680|141368859|SUPERIORITY||Risk Ratio (RR)|0.95||||0.171|TWO_SIDED|95.0|0.9|1.01|||Cochran-Mantel-Haenszel|||||1.01|0.90|0.171
70933733|NCT02409680|141368860|SUPERIORITY||Risk Ratio (RR)|0.86||||0.048|TWO_SIDED|95.0|0.73|1.0|||Cochran-Mantel-Haenszel|||||1.00|0.73|0.048
70933734|NCT02409680|141368861|SUPERIORITY||Risk Ratio (RR)|0.87||||0.125|TWO_SIDED|95.0|0.73|1.04|||Cochran-Mantel-Haenszel|||||1.04|0.73|0.125
70933735|NCT02409680|141368862|SUPERIORITY||Risk Ratio (RR)|1.03||||0.9|TWO_SIDED|95.0|0.6|1.79|||Cochran-Mantel-Haenszel|||||1.79|0.60|0.900
70933736|NCT02409680|141368863|SUPERIORITY||Risk Ratio (RR)|1.25||||0.274|TWO_SIDED|95.0|0.84|1.86|||Cochran-Mantel-Haenszel|||||1.86|0.84|0.274
70933737|NCT02409680|141368864|SUPERIORITY||Risk Ratio (RR)|0.75||||0.512|TWO_SIDED|95.0|0.32|1.78|||Cochran-Mantel-Haenszel|||||1.78|0.32|0.512
70933738|NCT02409680|141368865|SUPERIORITY||Risk Ratio (RR)|0.77||||0.331|TWO_SIDED|95.0|0.45|1.31|||Cochran-Mantel-Haenszel|||||1.31|0.45|0.331
70933739|NCT02409680|141368867|SUPERIORITY||Risk Ratio (RR)|0.38||||0.015|TWO_SIDED|95.0|0.17|0.85|||Cochran-Mantel-Haenszel|||||0.85|0.17|0.015
70851527|NCT01065454|141190971|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-239.31|||||TWO_SIDED|95.0|-363.4|-115.3||||||||-115.3|-363.4|
70851528|NCT01065454|141190971|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-120.89|||||TWO_SIDED|95.0|-274.4|32.6||||||||32.6|-274.4|
70851529|NCT01065454|141190971|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-25.54|||||TWO_SIDED|95.0|-189.3|138.2||||||||138.2|-189.3|
70851530|NCT01065454|141190972|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-446.49|||||TWO_SIDED|95.0|-687.4|-205.6||||||||-205.6|-687.4|
70851531|NCT01065454|141190972|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-231.57|||||TWO_SIDED|95.0|-530.4|67.2||||||||67.2|-530.4|
70851532|NCT01065454|141190972|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-34.97|||||TWO_SIDED|95.0|-353.7|283.7||||||||283.7|-353.7|
70851533|NCT01065454|141190973|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-1.27|||||TWO_SIDED|95.0|-3.1|0.5||||||||0.5|-3.1|
70851534|NCT01065454|141190973|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.88|||||TWO_SIDED|95.0|-3.1|1.3||||||||1.3|-3.1|
70851535|NCT01065454|141190973|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.84|||||TWO_SIDED|95.0|-3.2|1.5||||||||1.5|-3.2|
70851536|NCT01065454|141190974|SUPERIORITY_OR_OTHER_LEGACY||LSS-MEANS Difference|-2.07|||||TWO_SIDED|95.0|-5.0|0.8||||||||0.8|-5.0|
70851537|NCT01065454|141190974|SUPERIORITY_OR_OTHER_LEGACY||LS_MEANS|1.39|||||TWO_SIDED|95.0|-2.1|4.9||||||||4.9|-2.1|
70851538|NCT01065454|141190974|SUPERIORITY_OR_OTHER_LEGACY||LS_MEANS Difference|-1.13|||||TWO_SIDED|95.0|-4.9|2.7||||||||2.7|-4.9|
70851539|NCT01065454|141190975|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.28|||||TWO_SIDED|95.0|-0.58|1.14||||||||1.14|-0.58|
70851540|NCT01065454|141190975|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.82|||||TWO_SIDED|95.0|-0.23|1.87||||||||1.87|-0.23|
70851541|NCT01065454|141190975|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.03|||||TWO_SIDED|95.0|-1.11|1.06||||||||1.06|-1.11|
70851542|NCT01065454|141190976|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-3.84|||||TWO_SIDED|95.0|-8.76|1.09||||||||1.09|-8.76|
70851543|NCT01065454|141190976|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANs Difference|-0.02|||||TWO_SIDED|95.0|-6.05|6.01||||||||6.01|-6.05|
70851544|NCT01065454|141190976|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-2.43|||||TWO_SIDED|95.0|-8.93|4.06||||||||4.06|-8.93|
70933740|NCT02409680|141368868|SUPERIORITY||Risk Ratio (RR)|0.75||||0.039|TWO_SIDED|95.0|0.61|0.93|||Cochran-Mantel-Haenszel|||||0.93|0.61|0.039
70933741|NCT02409680|141368869|SUPERIORITY||Risk Ratio (RR)|0.93||||0.073|TWO_SIDED|95.0|0.87|1.01|||Cochran-Mantel-Haenszel|||||1.01|0.87|0.073
70933742|NCT02409680|141368870|SUPERIORITY||Risk Ratio (RR)|0.87||||0.084|TWO_SIDED|95.0|0.57|1.33|||Cochran-Mantel-Haenszel|||||1.33|0.57|0.084
70933743|NCT02409680|141368871|SUPERIORITY||Risk Ratio (RR)|0.86||||0.039|TWO_SIDED|95.0|0.73|1.0|||Cochran-Mantel-Haenszel|||||1.00|0.73|0.039
70933744|NCT02409680|141368872|SUPERIORITY||Risk Ratio (RR)|0.88||||0.261|TWO_SIDED|95.0|0.7|1.1|||Cochran-Mantel-Haenszel|||||1.10|0.70|0.261
70933745|NCT02409680|141368873|SUPERIORITY||Risk Ratio (RR)|0.85||||0.141|TWO_SIDED|95.0|0.68|1.06|||Cochran-Mantel-Haenszel|||||1.06|0.68|0.141
70933746|NCT02409680|141368874|SUPERIORITY||Risk Ratio (RR)|1.4||||0.157|TWO_SIDED|95.0|0.88|2.23|||Cochran-Mantel-Haenszel|||||2.23|0.88|0.157
70933747|NCT05200416|141368904|SUPERIORITY||Mean Difference (Final Values)|11.42|||<|0.001|TWO_SIDED|95.0|7.83|15.01|||Mixed Models Analysis|||||15.01|7.83|<0.001
70933748|NCT05200416|141368905|SUPERIORITY||Mean Difference (Final Values)|-4.16||||0.001|TWO_SIDED|95.0|-6.69|-1.63|||Mixed Models Analysis|||||-1.63|-6.69|0.001
71107556|NCT00565409|141721027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.11|||<|0.0001|TWO_SIDED|95.0|-16.7|-9.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-9.5|-16.7|<0.0001
71107557|NCT00565409|141721027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.53|||<|0.0001|TWO_SIDED|95.0|-16.1|-8.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-8.9|-16.1|<0.0001
71107558|NCT00565409|141721027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02||||0.5732|TWO_SIDED|95.0|-4.6|2.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization|ANCOVA|||Week 56||2.5|-4.6|0.5732
71107559|NCT00565409|141721027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.5|||<|0.0001|TWO_SIDED|95.0|-15.1|-7.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-7.9|-15.1|<0.0001
71107560|NCT00565409|141721027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.88|||<|0.0001|TWO_SIDED|95.0|-17.6|-10.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-10.2|-17.6|<0.0001
71107561|NCT00565409|141721027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.94||||0.2972|TWO_SIDED|95.0|-5.6|1.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||1.7|-5.6|0.2972
71107562|NCT00565409|141721027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.94|||<|0.0001|TWO_SIDED|95.0|-15.6|-8.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-8.3|-15.6|<0.0001
70941664|NCT04748445|141383934|OTHER||Slope|0.036|STANDARD_ERROR_OF_MEAN|5.634||0.524|TWO_SIDED|90.0|-0.05736|0.1294|||Mixed Models Analysis|||MM\_MFCC mean 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1294|-0.05736|0.5240
71107563|NCT00565409|141721027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.64|||<|0.0001|TWO_SIDED|95.0|-19.4|-11.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-11.8|-19.4|<0.0001
71107564|NCT00565409|141721027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.1477|TWO_SIDED|95.0|-6.6|1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||1.0|-6.6|0.1477
71107565|NCT00565409|141721027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.85|||<|0.0001|TWO_SIDED|95.0|-16.6|-9.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-9.0|-16.6|<0.0001
71107566|NCT00565409|141721027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.87|||<|0.0001|TWO_SIDED|95.0|-18.6|-11.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-11.1|-18.6|<0.0001
71107567|NCT00565409|141721027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.56||||0.1808|TWO_SIDED|95.0|-6.3|1.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||1.2|-6.3|0.1808
71107568|NCT00565409|141721027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.31|||<|0.0001|TWO_SIDED|95.0|-16.1|-8.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-8.5|-16.1|<0.0001
71107569|NCT00565409|141721027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.7|||<|0.0001|TWO_SIDED|95.0|-18.5|-10.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-10.9|-18.5|<0.0001
71107570|NCT00565409|141721027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.44||||0.2077|TWO_SIDED|95.0|-6.2|1.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||1.4|-6.2|0.2077
71107571|NCT00565409|141721027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.26|||<|0.0001|TWO_SIDED|95.0|-16.1|-8.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-8.5|-16.1|<0.0001
70933749|NCT05986617|141368906|SUPERIORITY|||||||0.06429||||||2-tail t-test with non-equivalent variances|t-test, 2 sided|||Power calculation: 2 factor (group, time) ANOVA design with a group\*time interaction term to estimate the proposed sample size. Using a Cohen's effect size estimate for 2 groups with 5 time-points, a sample size of 40 per group will provide \>90% to detect a moderate effect size (0.25) for group, for time and for the group\*time interaction.||||.06429
70933750|NCT03789656|141368909|OTHER|||||||0.6285|||||||Wilcoxon Signed Rank test|||The primary efficacy endpoint was completed with the Efficacy Analysis Set (EAS), which included all treated subjects in Group 1. The median (Interquartile range) for change from baseline in IGF-1xULN to Week 13/EoT and p-value from the Wilcoxon signed rank test were presented. Baseline was defined as the mean of all IGF-1xULN values prior to first dose. Last on treatment assessment was used for EoT if subject discontinued before Week 13.||||0.6285
70933751|NCT03789656|141368910|OTHER|||||||0.3877|||||||exact binomial test assuming the null pr|Null proportion = 0.5||||||0.3877
70933752|NCT06214052|141368940|OTHER||Emax|-2.69|STANDARD_ERROR_OF_MEAN|5.0||||||||||||||||
70933753|NCT06214052|141368940|OTHER||EC50|1.88|STANDARD_ERROR_OF_MEAN|26.0||||||||||||||||
70933754|NCT02434328|141368945|NON_INFERIORITY|The noninferiority margin was 4 letters.|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.86|<|0.0001|TWO_SIDED|95.0|-2.4|1.0||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||1.0|-2.4|<0.0001
70933755|NCT02434328|141368946|NON_INFERIORITY|The non-inferiority margin was 4 letters.|Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.82||0.0003|TWO_SIDED|95.0|-2.8|0.5||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||0.5|-2.8|0.0003
70933756|NCT02434328|141368951|OTHER|Treatment difference|Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-2.0|0.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4||0.0|-2.0|
70851545|NCT01065454|141190977|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.51|||||TWO_SIDED|95.0|-0.21|1.24||||||||1.24|-0.21|
70933757|NCT02434328|141368951|OTHER|Treatment difference|Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-2.2|0.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8||0.2|-2.2|
70933758|NCT02434328|141368951|OTHER|Treatment difference|Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.71|||TWO_SIDED|95.0|-2.4|0.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||0.4|-2.4|
70933759|NCT02434328|141368951|OTHER|Treatment difference|Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-2.3|0.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16||0.6|-2.3|
70933760|NCT02434328|141368951|OTHER|Treatment difference|Least Squares Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-3.0|0.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20||0.0|-3.0|
70933761|NCT02434328|141368951|OTHER|Treatment difference|Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.79|||TWO_SIDED|95.0|-2.5|0.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||0.6|-2.5|
70851546|NCT01065454|141190977|SUPERIORITY_OR_OTHER_LEGACY||LS_MEANS Difference|0.81|||||TWO_SIDED|95.0|-0.07|1.69||||||||1.69|-0.07|
70933762|NCT02434328|141368951|OTHER|Treatment difference|Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|95.0|-2.7|0.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28||0.5|-2.7|
70933763|NCT02434328|141368951|OTHER|Treatment difference|Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.81|||TWO_SIDED|95.0|-2.5|0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32||0.7|-2.5|
71056052|NCT00261443|141616313|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.14||||0.159|TWO_SIDED|95.0|-0.34|0.06||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.06|-0.34|0.159
71056053|NCT00261443|141616313|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.11||||0.305|TWO_SIDED|95.0|-0.31|0.1||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.10|-0.31|0.305
71056054|NCT00261443|141616313|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.13||||0.251|TWO_SIDED|95.0|-0.35|0.09||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.09|-0.35|0.251
71107572|NCT00565409|141721028|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0001
70933764|NCT02434328|141368951|OTHER|Treatment difference|Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|95.0|-2.9|0.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36||0.4|-2.9|
70933765|NCT02434328|141368951|OTHER|Treatment difference|Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|95.0|-2.9|0.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40||0.5|-2.9|
70933766|NCT02434328|141368951|OTHER|Treatment difference|Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|95.0|-3.2|0.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44||0.1|-3.2|
70933767|NCT02434328|141368951|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|95.0|-2.4|1.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||1.0|-2.4|
70851547|NCT01065454|141190977|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.2|||||TWO_SIDED|95.0|-0.74|1.15||||||||1.15|-0.74|
70851548|NCT01065454|141190978|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-5.06|||||TWO_SIDED|95.0|-17.33|7.22||||||||7.22|-17.33|
71056055|NCT00261443|141616313|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.17||||0.135|TWO_SIDED|95.0|-0.4|0.05||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||0.05|-0.40|0.135
70851549|NCT01065454|141190978|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.28|||||TWO_SIDED|95.0|-14.55|15.11||||||||15.11|-14.55|
70851550|NCT01065454|141190978|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-5.18|||||TWO_SIDED|95.0|-21.05|10.69||||||||10.69|-21.05|
70851551|NCT01065454|141190979|SUPERIORITY_OR_OTHER_LEGACY||LS_MEANS Difference|-4.27|||||TWO_SIDED|95.0|-21.13|12.6||||||||12.60|-21.13|
70851552|NCT01065454|141190979|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|2.78|||||TWO_SIDED|95.0|-17.59|23.16||||||||23.16|-17.59|
70933768|NCT02434328|141368951|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-2.5|1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52||1.1|-2.5|
70933769|NCT02434328|141368951|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.92|||TWO_SIDED|95.0|-2.5|1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56||1.1|-2.5|
70933770|NCT02434328|141368951|OTHER|Treatment difference|Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.93|||TWO_SIDED|95.0|-2.7|1.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60||1.0|-2.7|
70933771|NCT02434328|141368951|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.95|||TWO_SIDED|95.0|-2.5|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64||1.2|-2.5|
70851553|NCT01065454|141190979|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-4.61|||||TWO_SIDED|95.0|-26.43|17.2||||||||17.20|-26.43|
70851554|NCT01065454|141190980|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|5.29|||||TWO_SIDED|95.0|-7.38|17.95||||||||17.95|-7.38|
70851555|NCT01065454|141190980|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|6.47|||||TWO_SIDED|95.0|-9.79|22.73||||||||22.73|-9.79|
70851556|NCT01065454|141190980|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|10.35|||||TWO_SIDED|95.0|-6.14|26.84||||||||26.84|-6.14|
70851557|NCT01065454|141190981|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.15|||||TWO_SIDED|95.0|-0.55|0.24||||||||0.24|-0.55|
70851558|NCT01065454|141190981|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.17|||||TWO_SIDED|95.0|-0.34|0.67||||||||0.67|-0.34|
70851559|NCT01065454|141190981|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.06|||||TWO_SIDED|95.0|-0.45|0.56||||||||0.56|-0.45|
70851560|NCT01065454|141190982|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|10.17|||||TWO_SIDED|95.0|-18.48|38.81||||||||38.81|-18.48|
70851561|NCT01065454|141190982|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|7.92|||||TWO_SIDED|95.0|-26.76|42.59||||||||42.59|-26.76|
70851562|NCT01065454|141190982|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-6.15|||||TWO_SIDED|95.0|-44.08|31.78||||||||31.78|-44.08|
70851563|NCT01065454|141190984|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.62|||||TWO_SIDED|95.0|-13.36|14.61||||||||14.61|-13.36|
70851564|NCT01065454|141190984|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-9.46|||||TWO_SIDED|95.0|-24.32|5.39||||||||5.39|-24.32|
70851565|NCT01065454|141190984|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-6.07|||||TWO_SIDED|95.0|-22.26|10.13||||||||10.13|-22.26|
70851566|NCT01065454|141190986|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.03|||||TWO_SIDED|95.0|-0.04|0.1||||||||0.10|-0.04|
70851567|NCT01065454|141190986|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.01|||||TWO_SIDED|95.0|-0.07|0.09||||||||0.09|-0.07|
70851568|NCT01065454|141190986|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.02|||||TWO_SIDED|95.0|-0.07|0.11||||||||0.11|-0.07|
70851569|NCT01065454|141190987|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-6.8|||||TWO_SIDED|95.0|-12.81|-0.78||||||||-0.78|-12.81|
70851570|NCT01065454|141190987|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-6.81|||||TWO_SIDED|95.0|-13.96|0.35||||||||0.35|-13.96|
70851571|NCT01065454|141190987|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-7.5|||||TWO_SIDED|95.0|-15.29|0.28||||||||0.28|-15.29|
70851572|NCT01065454|141190988|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-24.62|||||TWO_SIDED|95.0|-117.58|68.33||||||||68.33|-117.58|
71107573|NCT00565409|141721029|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.8974|TWO_SIDED|95.0|0.5|2.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||2.5|0.5|0.8974
70851573|NCT01065454|141190988|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-53.29|||||TWO_SIDED|95.0|-162.46|55.88||||||||55.88|-162.46|
70851574|NCT01065454|141190988|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-8.36|||||TWO_SIDED|95.0|-135.78|119.06||||||||119.06|-135.78|
70851575|NCT01065454|141190989|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-407.34|||||TWO_SIDED|95.0|-1055.23|240.54||||||||240.54|-1055.23|
70851576|NCT01065454|141190989|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-447.26|||||TWO_SIDED|95.0|-1212.74|318.22||||||||318.22|-1212.74|
70851577|NCT01065454|141190989|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-517.48|||||TWO_SIDED|95.0|-1369.48|334.53||||||||334.53|-1369.48|
70851578|NCT01065454|141190990|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.01||||||||0.01|-0.01|
70851579|NCT01065454|141190990|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.01|||||TWO_SIDED|95.0|-0.02|0.0||||||||0.00|-0.02|
70851580|NCT01065454|141190990|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.01|||||TWO_SIDED|95.0|-0.02|0.01||||||||0.01|-0.02|
70851581|NCT01065454|141190991|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.0|||||TWO_SIDED|95.0|-0.04|0.03||||||||0.03|-0.04|
70851582|NCT01065454|141190991|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.0|||||TWO_SIDED|95.0|-0.04|0.05||||||||0.05|-0.04|
70851583|NCT01065454|141190991|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.02|||||TWO_SIDED|95.0|-0.07|0.03||||||||0.03|-0.07|
70851584|NCT01065454|141190992|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANSA Difference|-14.13|||||TWO_SIDED|95.0|-30.79|2.53||||||||2.53|-30.79|
70851585|NCT01065454|141190992|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-12.73|||||TWO_SIDED|95.0|-32.89|7.43||||||||7.43|-32.89|
70851586|NCT01065454|141190992|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-18.27|||||TWO_SIDED|95.0|-41.53|5.0||||||||5.00|-41.53|
70851587|NCT05688670|141190995|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.001|TWO_SIDED|95.0|-0.59|-0.18|||t-test, 2 sided|||||-0.18|-0.59|0.001
70851588|NCT05688670|141190996|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.41|TWO_SIDED|95.0|-0.2|0.08|||t-test, 2 sided|||12-24 hour postoperative opioid use||0.08|-0.20|0.41
70851589|NCT05688670|141190996|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.14|TWO_SIDED|95.0|-0.37|0.06|||t-test, 2 sided|||24-48 hour postoperative opioid use||0.06|-0.37|0.14
70851590|NCT05688670|141190996|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.16|TWO_SIDED|95.0|-0.52|0.09|||t-test, 2 sided|||12-48 hours hours after surgery||0.09|-0.52|0.16
70851591|NCT05688670|141190997|SUPERIORITY||Mean Difference (Final Values)|-0.64||||0.004|TWO_SIDED|95.0|-1.02|-0.22|||t-test, 2 sided|||||-0.22|-1.02|0.004
70851592|NCT05688670|141190998|SUPERIORITY||Mean Difference (Final Values)|-49.5||||0.002|TWO_SIDED|95.0|-78.9|-20.1|||t-test, 2 sided|||||-20.1|-78.9|0.002
70851593|NCT03425253|141191000|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Investigator: Both Sides of Face, Last Treatment||||<0.001
70851594|NCT03425253|141191000|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Investigator: Right Side of Face, Last Treatment||||<0.001
70851595|NCT03425253|141191000|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Investigator: Left Side of Face, Last Treatment||||<0.001
70851596|NCT03425253|141191000|OTHER|||||||0.018||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Independent Reviewer: Both Sides of Face, Last Treatment||||0.018
70851597|NCT03425253|141191000|OTHER|||||||0.301||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Independent Reviewer: Right Side of Face, Last Treatment||||0.301
70851598|NCT03425253|141191000|OTHER|||||||0.011||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Independent Reviewer: Left Side of Face, Last Treatment||||0.011
70851599|NCT03425253|141191001|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||||||<0.001
70851600|NCT03425253|141191002|OTHER|||||||0.597||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||||||0.597
70851601|NCT03425253|141191003|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||||||<0.001
70851602|NCT03425253|141191004|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||||||<0.001
70851603|NCT03425253|141191005|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||||||<0.001
70851604|NCT03425253|141191006|OTHER|||||||0.003||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||||||0.003
71022650|NCT05478603|141553327|OTHER||Ratio of adjusted geometric means|93.29|||||TWO_SIDED|90.0|64.61|134.69|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||134.69|64.61|
70851605|NCT03425253|141191007|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Both Side of the Face, End of Study||||<0.001
70851606|NCT03425253|141191007|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Right Side of the Face, End of study||||<0.001
70851607|NCT03425253|141191007|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Left Side of the Face, End of Study||||<0.001
70851608|NCT03844945|141191016|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70851609|NCT01043939|141191022|SUPERIORITY_OR_OTHER||Difference of least square means|-0.16||||0.25|TWO_SIDED|95.0|-0.42|0.11||24 participants required to achieve 80% power to detect mean difference of 0.3 in RH-PAT index score between juice groups, assuming standard deviation of the difference was 0.25, using a two-sided significance level of 0.05|Mixed Models Analysis|Mixed effects ANCOVA model with baseline included as a covariate, subject as a random effect; juice, period \& group as fixed effects.|The a priori threshold for statistical significance was 0.05.|||0.11|-0.42|0.25
71107574|NCT00565409|141721029|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.1105|TWO_SIDED|95.0|0.8|3.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||3.7|0.8|0.1105
70851610|NCT01043939|141191023|SUPERIORITY_OR_OTHER||Difference of least square means|3.09||||0.29|TWO_SIDED|95.0|-2.73|8.91|||Mixed Models Analysis|Mixed effects ANCOVA model with baseline included as a covariate, subject as a random effect; juice, period \& group as fixed effects.||||8.91|-2.73|0.29
71056056|NCT00261443|141616313|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.22||||0.073|TWO_SIDED|95.0|-0.46|0.02||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||0.02|-0.46|0.073
71056057|NCT00261443|141616313|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.26||||0.034|TWO_SIDED|95.0|-0.5|-0.02||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||-0.02|-0.50|0.034
71056058|NCT00261443|141616313|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.17||||0.174|TWO_SIDED|95.0|-0.41|0.07||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||0.07|-0.41|0.174
70933772|NCT02434328|141368951|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|-2.5|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68||1.2|-2.5|
71056059|NCT00261443|141616313|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.19||||0.132|TWO_SIDED|95.0|-0.43|0.06||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||0.06|-0.43|0.132
71056060|NCT00261443|141616313|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.18||||0.152|TWO_SIDED|95.0|-0.42|0.07||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||0.07|-0.42|0.152
71056061|NCT00261443|141616313|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.23||||0.06|TWO_SIDED|95.0|-0.48|0.01||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||0.01|-0.48|0.060
71056062|NCT00261443|141616313|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.22||||0.085|TWO_SIDED|95.0|-0.46|0.03||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||0.03|-0.46|0.085
71056063|NCT00261443|141616316|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.04||||0.774|TWO_SIDED|95.0|-0.25|0.33||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.33|-0.25|0.774
70933773|NCT02434328|141368951|OTHER|Treatment difference|Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|95.0|-2.8|1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||1.1|-2.8|
71056064|NCT00261443|141616316|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.19||||0.213|TWO_SIDED|95.0|-0.49|0.11||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.11|-0.49|0.213
70851611|NCT01043939|141191024|SUPERIORITY_OR_OTHER||Ratio of means|0.92||||0.15|TWO_SIDED|95.0|0.82|1.03|||Mixed Models Analysis|Mixed effects ANCOVA model with baseline included as a covariate, subject as a random effect; juice, period \& group as fixed effects.|MPO was log transformed prior to analyses; the difference of log-transformed least square means (95% CI) were back-transformed to obtain the ratio of the means (95% CI).|||1.03|0.82|0.15
70941665|NCT04748445|141383934|OTHER||Slope|2.909|STANDARD_ERROR_OF_MEAN|3.096||0.3493|TWO_SIDED|90.0|-2.222|8.039|||Mixed Models Analysis|||MM\_MFCC std 01 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||8.039|-2.222|0.3493
70851612|NCT01043939|141191025|SUPERIORITY_OR_OTHER||Ratio of means|1.34||||0.37|TWO_SIDED|95.0|0.69|2.62|||Mixed Models Analysis|Mixed effects ANCOVA model with baseline included as a covariate, subject as a random effect; juice, period \& group as fixed effects.|hs-CRP was log transformed prior to analyses; the difference of log-transformed least square means (95% CI) were back-transformed to obtain the ratio of the means (95% CI).|||2.62|0.69|0.37
70851613|NCT00265148|141191056|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1334||||0.1695|TWO_SIDED|95.0|-0.0583|0.3251|||Mixed model for repeated measures|||For Grey matter||0.3251|-0.0583|0.1695
70851614|NCT00265148|141191056|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.175||||0.1057|TWO_SIDED|95.0|-0.038|0.388|||Mixed model for repeated measures|||For posterior cingulate Gyrus||0.3880|-0.0380|0.1057
70851615|NCT00265148|141191056|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1426||||0.1833|TWO_SIDED|95.0|-0.0691|0.3543|||Mixed model for repeated measures|||For Frontal lobe||0.3543|-0.0691|0.1833
70933774|NCT02434328|141368951|OTHER|Treatment difference|Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|95.0|-2.5|1.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76||1.4|-2.5|
71022651|NCT05478603|141553327|OTHER||Ratio of adjusted geometric means|106.68|||||TWO_SIDED|90.0|73.89|154.03|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||154.03|73.89|
71022652|NCT05478603|141553327|OTHER||Ratio of adjusted geometric means|246.28|||||TWO_SIDED|90.0|170.57|355.58|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||355.58|170.57|
71022653|NCT05478603|141553328|OTHER||Ratio of adjusted geometric means|88.5|||||TWO_SIDED|90.0|64.13|122.12|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||122.12|64.13|
71022654|NCT05478603|141553328|OTHER||Ratio of adjusted geometric means|106.4|||||TWO_SIDED|90.0|77.11|146.83|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||146.83|77.11|
71022655|NCT05478603|141553328|OTHER||Ratio of adjusted geometric means|169.19|||||TWO_SIDED|90.0|122.61|233.47|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||233.47|122.61|
71022656|NCT05478603|141553329|OTHER||Ratio of adjusted geometric means|95.12|||||TWO_SIDED|90.0|52.6|172.03|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||172.03|52.60|
71107575|NCT00565409|141721029|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.19|TWO_SIDED|95.0|0.3|1.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||1.4|0.3|0.1900
70851616|NCT00265148|141191056|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1366||||0.1644|TWO_SIDED|95.0|-0.0574|0.3307|||Mixed model for repeated measures|||For parietal lobe||0.3307|-0.0574|0.1644
70851617|NCT00265148|141191056|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1259||||0.1509|TWO_SIDED|95.0|-0.0471|0.2989|||Mixed model for repeated measures|||For Posterior temporal lobe||0.2989|-0.0471|0.1509
70851618|NCT00265148|141191056|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1339||||0.2041|TWO_SIDED|95.0|-0.0747|0.3424|||Mixed model for repeated measures|||For cerebellum||0.3424|-0.0747|0.2041
70851619|NCT00265148|141191056|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1094||||0.1445|TWO_SIDED|95.0|-0.0385|0.2572|||Mixed model for repeated measures|||For medial temporal lobe||0.2572|-0.0385|0.1445
70851620|NCT00265148|141191057|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1211||||0.2251|TWO_SIDED|95.0|-0.0763|0.3185|||Mixed model for repeated measures|||At Month 1||0.3185|-0.0763|0.2251
70851621|NCT00265148|141191057|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0893||||0.2497|TWO_SIDED|95.0|-0.0643|0.243|||Mixed model for repeated measures|||For Month 6||0.2430|-0.0643|0.2497
70851622|NCT00265148|141191058|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.11||||0.7618|TWO_SIDED|95.0|-0.59|0.8|||Repeated measure mixed model|||For BSR test , Month 1||0.80|-0.59|0.7618
70851623|NCT00265148|141191058|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.06||||0.835|TWO_SIDED|95.0|-0.53|0.66|||Repeated measure mixed model|||For BSR test, Month 6||0.66|-0.53|0.8350
70851624|NCT00265148|141191058|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.14||||0.6735|TWO_SIDED|95.0|-0.78|0.51|||Repeated measure mixed model|||For BSR test, Month 12||0.51|-0.78|0.6735
70851625|NCT00265148|141191059|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.07||||0.7045|TWO_SIDED|95.0|-0.44|0.3|||Repetaed measure mixed model|||For Month 1||0.30|-0.44|0.7045
70933775|NCT02434328|141368951|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-2.1|1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80||1.8|-2.1|
70933776|NCT02434328|141368951|OTHER|Treatment difference|Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-2.9|1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84||1.1|-2.9|
70933777|NCT02434328|141368951|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-2.6|1.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88||1.3|-2.6|
70933778|NCT02434328|141368951|OTHER|Treatment difference|Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|95.0|-2.4|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92||1.6|-2.4|
70933779|NCT02434328|141368951|OTHER|Treatment difference|Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|95.0|-2.5|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||1.6|-2.5|
70933780|NCT02434328|141368952|OTHER|Treatment difference|Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-2.4|0.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 48||0.3|-2.4|
70933781|NCT02434328|141368952|OTHER|Treatment difference|Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|95.0|-2.4|0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 96||0.7|-2.4|
71056065|NCT00261443|141616316|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.12||||0.465|TWO_SIDED|95.0|-0.43|0.2||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.20|-0.43|0.465
70933782|NCT02434328|141368953|OTHER|Treatment difference|Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|95.0|-2.5|0.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12 to Week 48||0.4|-2.5|
70933783|NCT02434328|141368953|OTHER|Treatment difference|Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|95.0|-2.4|0.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.||Week 12 to Week 96|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|0.8|-2.4|
71056066|NCT00261443|141616316|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.068|TWO_SIDED|95.0|-0.59|0.02||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.02|-0.59|0.068
71056067|NCT00261443|141616316|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.27||||0.095|TWO_SIDED|95.0|-0.58|0.05||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.05|-0.58|0.095
71056068|NCT00261443|141616316|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.082|TWO_SIDED|95.0|-0.62|0.04||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||0.04|-0.62|0.082
71056069|NCT00261443|141616316|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.36||||0.033|TWO_SIDED|95.0|-0.69|-0.03||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||-0.03|-0.69|0.033
71056070|NCT00261443|141616316|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.31||||0.062|TWO_SIDED|95.0|-0.64|0.02||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||0.02|-0.64|0.062
71107576|NCT00565409|141721029|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.18|||<|0.0001|TWO_SIDED|95.0|2.3|7.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||7.5|2.3|<0.0001
70851626|NCT00265148|141191059|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.04||||0.8181|TWO_SIDED|95.0|-0.4|0.32|||Repeated measure mixed model|||For Month 6||0.32|-0.40|0.8181
71056071|NCT00261443|141616316|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.43||||0.011|TWO_SIDED|95.0|-0.76|-0.1||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||-0.10|-0.76|0.011
70933784|NCT02434328|141368954|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-2.5|1.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||1.4|-2.5|
71056072|NCT00261443|141616316|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.37||||0.027|TWO_SIDED|95.0|-0.7|-0.04||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||-0.04|-0.70|0.027
71056073|NCT00261443|141616316|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.37||||0.029|TWO_SIDED|95.0|-0.71|-0.04||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||-0.04|-0.71|0.029
71056074|NCT00261443|141616316|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.4||||0.022|TWO_SIDED|95.0|-0.74|-0.06||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||-0.06|-0.74|0.022
71056075|NCT00261443|141616316|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.4||||0.023|TWO_SIDED|95.0|-0.75|-0.06||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||-0.06|-0.75|0.023
71056076|NCT00261443|141616318|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.09||||0.486|TWO_SIDED|95.0|-0.17|0.36||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.36|-0.17|0.486
71056077|NCT00261443|141616318|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.04||||0.793|TWO_SIDED|95.0|-0.3|0.23||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.23|-0.30|0.793
71056078|NCT00261443|141616318|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.06||||0.665|TWO_SIDED|95.0|-0.34|0.22||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.22|-0.34|0.665
71056079|NCT00261443|141616318|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.07||||0.65|TWO_SIDED|95.0|-0.35|0.22||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.22|-0.35|0.650
71056080|NCT00261443|141616318|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.06||||0.705|TWO_SIDED|95.0|-0.34|0.23||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.23|-0.34|0.705
71056081|NCT00261443|141616318|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.08||||0.572|TWO_SIDED|95.0|-0.38|0.21||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||0.21|-0.38|0.572
71056082|NCT00261443|141616318|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.12||||0.418|TWO_SIDED|95.0|-0.43|0.18||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||0.18|-0.43|0.418
71056083|NCT00261443|141616318|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.2||||0.185|TWO_SIDED|95.0|-0.51|0.1||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||0.10|-0.51|0.185
71107577|NCT00565409|141721029|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.4032|TWO_SIDED|95.0|0.6|2.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||2.4|0.6|0.4032
71107578|NCT00565409|141721029|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.23|||<|0.0001|TWO_SIDED|95.0|2.4|7.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||7.5|2.4|<0.0001
71107579|NCT00565409|141721029|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.92|||<|0.0001|TWO_SIDED|95.0|2.1|7.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||7.2|2.1|<0.0001
70941666|NCT04748445|141383934|OTHER||Slope|1.72|STANDARD_ERROR_OF_MEAN|2.595||0.5087|TWO_SIDED|90.0|-2.58|6.019|||Mixed Models Analysis|||MM\_MFCC std 02 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||6.019|-2.580|0.5087
71107580|NCT00565409|141721029|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9||||0.0272|TWO_SIDED|95.0|1.0|3.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||3.6|1.0|0.0272
71107581|NCT00565409|141721029|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.34||||0.0004|TWO_SIDED|95.0|1.4|4.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||4.0|1.4|0.0004
71107582|NCT00565409|141721030|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 4||||<0.0001
71107583|NCT00565409|141721030|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8||||<0.0001
71107584|NCT00565409|141721030|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||<0.0001
71107585|NCT00565409|141721030|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20||||<0.0001
71107586|NCT00565409|141721030|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||<0.0001
71107587|NCT00565409|141721030|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 36||||<0.0001
71107588|NCT00565409|141721031|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.29||||0.1718|TWO_SIDED|95.0|0.5|10.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||10.7|0.5|0.1718
71107589|NCT00565409|141721031|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.8303|TWO_SIDED|95.0|0.2|7.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||7.3|0.2|0.8303
70851627|NCT00265148|141191059|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.09||||0.7688|TWO_SIDED|95.0|-0.71|0.53|||Repeated measure mixed model|||AT Month 12||0.53|-0.71|0.7688
71107590|NCT00565409|141721031|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.27||||0.213|TWO_SIDED|95.0|0.5|10.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||10.1|0.5|0.2130
71107591|NCT00565409|141721031|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1|||<|0.0001|TWO_SIDED|95.0|2.1|8.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||8.2|2.1|<0.0001
71107592|NCT00565409|141721031|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.4337|TWO_SIDED|95.0|0.3|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||2.0|0.3|0.4337
71107593|NCT00565409|141721031|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.14|||<|0.0001|TWO_SIDED|95.0|2.5|10.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||10.8|2.5|<0.0001
71107594|NCT00565409|141721031|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.61|||<|0.0001|TWO_SIDED|95.0|3.0|10.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||10.5|3.0|<0.0001
71107595|NCT00565409|141721031|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.8973|TWO_SIDED|95.0|0.4|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||1.9|0.4|0.8973
71107596|NCT00565409|141721031|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.33|||<|0.0001|TWO_SIDED|95.0|2.8|10.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||10.1|2.8|<0.0001
71107597|NCT00565409|141721031|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.0001|TWO_SIDED|95.0|2.4|8.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||8.1|2.4|<0.0001
71107598|NCT00565409|141721031|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.5708|TWO_SIDED|95.0|0.4|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||1.7|0.4|0.5708
71107599|NCT00565409|141721031|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.58|||<|0.0001|TWO_SIDED|95.0|3.0|10.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||10.3|3.0|<0.0001
71107600|NCT00565409|141721031|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.29|||<|0.0001|TWO_SIDED|95.0|3.3|12.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||12.0|3.3|<0.0001
71107601|NCT00565409|141721031|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.8842|TWO_SIDED|95.0|0.4|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||2.0|0.4|0.8842
71107602|NCT00565409|141721031|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.92|||<|0.0001|TWO_SIDED|95.0|3.2|10.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||10.8|3.2|<0.0001
71022657|NCT05478603|141553329|OTHER||Ratio of adjusted geometric means|166.77|||||TWO_SIDED|90.0|92.21|301.62|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||301.62|92.21|
71022658|NCT05478603|141553329|OTHER||Ratio of adjusted geometric means|237.76|||||TWO_SIDED|90.0|131.46|430.0|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||430.00|131.46|
71022659|NCT05478603|141553330|OTHER||Ratio of adjusted geometric means|95.34|||||TWO_SIDED|90.0|52.67|172.59|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||172.59|52.67|
71022660|NCT05478603|141553330|OTHER||Ratio of adjusted geometric means|163.09|||||TWO_SIDED|90.0|90.1|295.22|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||295.22|90.10|
71056084|NCT00261443|141616318|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.1||||0.536|TWO_SIDED|95.0|-0.41|0.21||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||0.21|-0.41|0.536
71107603|NCT00565409|141721031|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.39|||<|0.0001|TWO_SIDED|95.0|3.8|14.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||14.4|3.8|<0.0001
71107604|NCT00565409|141721031|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.1608|TWO_SIDED|95.0|0.6|3.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||3.1|0.6|0.1608
71107605|NCT00565409|141721031|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.92|||<|0.0001|TWO_SIDED|95.0|2.9|8.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||8.4|2.9|<0.0001
70933785|NCT02434328|141368955|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-5.1|2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||2.9|-5.1|
70933786|NCT02434328|141368955|OTHER||Difference in proportions|-4.3|||||TWO_SIDED|95.0|-9.5|1.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.0|-9.5|
70933787|NCT02434328|141368955|OTHER||Difference in proportions|-5.0|||||TWO_SIDED|95.0|-10.5|0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||0.3|-10.5|
70933788|NCT02434328|141368955|OTHER||Difference in proportions|-2.3|||||TWO_SIDED|95.0|-8.4|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||3.7|-8.4|
71107606|NCT00565409|141721031|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.44|||<|0.0001|TWO_SIDED|95.0|3.4|12.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||12.4|3.4|<0.0001
71107607|NCT00565409|141721031|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.2825|TWO_SIDED|95.0|0.6|2.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||2.7|0.6|0.2825
71107608|NCT00565409|141721031|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.59|||<|0.0001|TWO_SIDED|95.0|2.7|7.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||7.8|2.7|<0.0001
71107609|NCT00565409|141721031|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.81|||<|0.0001|TWO_SIDED|95.0|2.7|8.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||8.7|2.7|<0.0001
71107610|NCT00565409|141721031|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.4471|TWO_SIDED|95.0|0.5|2.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||2.1|0.5|0.4471
71107611|NCT00565409|141721031|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.19|||<|0.0001|TWO_SIDED|95.0|2.5|7.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||7.0|2.5|<0.0001
71107612|NCT00565409|141721032|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4||||<0.0001
70933789|NCT02434328|141368955|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-8.8|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||2.8|-8.8|
71022661|NCT05478603|141553330|OTHER||Ratio of adjusted geometric means|239.47|||||TWO_SIDED|90.0|132.29|433.47|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||433.47|132.29|
71022662|NCT03182686|141553341|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"H0:π ≤ π0 versus HA:π \> π0~Where π0 is the hypothesized clinically significant value for the proportion of responders. The value will be 30% in this study. This test will be tested using an exact binomial test. That is, given the sample size of n, the number of responders X, and the value of π0 =0.30, then probability that X or more events would be observed will be calculated as the p-value. Since this is a one-sided test, the alpha level will be 0.025."||||<0.0001
71022663|NCT00185211|141553368|SUPERIORITY_OR_OTHER|||||||0.0027||95.0||||A 2-sided error level of 0.0253 was used for analyses at month 36 and 60 in order to keep the study-wise error level at 0.05. A conditional sequential testing approach was used for the family of null hypotheses of the primary efficacy variables.|Log Rank|||"The null hypothesis for comparison of initial IFNB-1b versus initial placebo treatment was:~H0: The survival functions (i.e., the probability that time to CDMS is ≥ t) are identical for both treatment arms for all points in time t\>0.~The two-sided alternative hypothesis was:~H1: The survival functions (i.e., the probability that time to CDMS is ≥ t) are not identical for both treatment arms for some points in time t\>0."||||0.0027
71056085|NCT00261443|141616318|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.07||||0.637|TWO_SIDED|95.0|-0.39|0.24||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||0.24|-0.39|0.637
71056086|NCT00261443|141616318|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.03||||0.875|TWO_SIDED|95.0|-0.34|0.29||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||0.29|-0.34|0.875
71107613|NCT00565409|141721032|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8||||<0.0001
71107614|NCT00565409|141721032|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||<0.0001
71107615|NCT00565409|141721032|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20||||<0.0001
71107616|NCT00565409|141721032|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||<0.0001
71107617|NCT00565409|141721032|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 36||||<0.0001
71107618|NCT00565409|141721033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.6006|TWO_SIDED|95.0|0.4|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||1.6|0.4|0.6006
71107619|NCT00565409|141721033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.4967|TWO_SIDED|95.0|0.6|2.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||2.1|0.6|0.4967
71107620|NCT00565409|141721033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.3648|TWO_SIDED|95.0|0.4|1.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||1.5|0.4|0.3648
71107621|NCT00565409|141721033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.98||||0.0024|TWO_SIDED|95.0|1.2|3.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||3.2|1.2|0.0024
71107622|NCT00565409|141721033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.8308||95.0|0.6|||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||1.|0.6|0.8308
71107623|NCT00565409|141721033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13||||0.0008|TWO_SIDED|95.0|1.3|3.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||3.4|1.3|0.0008
71107624|NCT00565409|141721033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.25|||<|0.0001|TWO_SIDED|95.0|2.0|5.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||5.2|2.0|<0.0001
71107625|NCT00565409|141721033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.7374|TWO_SIDED|95.0|0.7|1.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||1.8|0.7|0.7374
71107626|NCT00565409|141721033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.04|||<|0.0001|TWO_SIDED|95.0|1.9|4.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||4.8|1.9|<0.0001
71107627|NCT00565409|141721033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.0001|TWO_SIDED|95.0|1.9|4.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||4.8|1.9|<0.0001
71107628|NCT00565409|141721033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.9599|TWO_SIDED|95.0|0.6|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||1.7|0.6|0.9599
70933790|NCT02434328|141368955|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-5.2|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||6.7|-5.2|
70933791|NCT02434328|141368955|OTHER||Difference in proportions|-3.7|||||TWO_SIDED|95.0|-9.9|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.3|-9.9|
70933792|NCT02434328|141368955|OTHER||Difference in proportions|-3.6|||||TWO_SIDED|95.0|-10.5|2.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||2.7|-10.5|
70933793|NCT02434328|141368955|OTHER||Difference in proportions|-4.9|||||TWO_SIDED|95.0|-11.6|1.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||1.3|-11.6|
70933794|NCT02434328|141368955|OTHER||Difference in proportions|-4.7|||||TWO_SIDED|95.0|-11.5|1.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||1.9|-11.5|
70933795|NCT02434328|141368955|OTHER||Difference in proportions|-4.6|||||TWO_SIDED|95.0|-11.3|1.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||1.8|-11.3|
70933796|NCT02434328|141368955|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-7.1|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||5.8|-7.1|
70933797|NCT02434328|141368955|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-7.0|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||5.5|-7.0|
70933798|NCT02434328|141368955|OTHER||Difference in proportions|-1.1|||||TWO_SIDED|95.0|-7.7|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||5.4|-7.7|
71022664|NCT00185211|141553368|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.663||||0.0028||97.47|0.488|0.902|||Regression, Cox|covariate adjustment: steroid use during first event, onset of disease, categorized number of T2 lesions at screening|The direction of comparison is initial IFNB-1b (numerator) versus initial placebo (denominator), i.e. the Hazard Ratio represents the relative risk of initial IFNB-1b treatment compared to initial placebo treatment.|Time to CDMS was modelled by a Cox proportional hazards regression model with the following covariates: treatment group, steroid use during first event (yes vs. no), onset of disease (monofocal vs. multifocal) and number of T2 lesions at screening (categories: 2-4, 5-8 and at least 9 T2 lesions). The null hypothesis was: Initial IFNB-1b and initial placebo do not differ with regard to the hazard for CDMS, i.e. hazard ratio = 1.||0.902|0.488|0.0028
70933799|NCT02434328|141368955|OTHER||Difference in proportions|-2.2|||||TWO_SIDED|95.0|-8.3|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||4.2|-8.3|
70933800|NCT02434328|141368955|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-7.9|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.4|-7.9|
71022665|NCT00185211|141553369|SUPERIORITY_OR_OTHER|||||||0.1768||95.0||||A 2-sided error level of 0.0253 was used for analyses at month 36 and 60 in order to keep the study-wise error level at 0.05. A conditional sequential testing approach was used for the family of null hypotheses of the primary efficacy variables.|Log Rank|||The null hypothesis for comparison of initial IFNB-1b versus initial placebo treatment was: H0: The survival functions (i.e., the probability that time to confirmed EDSS progression is ≥ t) are not identical for both treatment arms for some points in time t\>0. The two-sided alternative hypothesis was: H1: The survival functions (i.e., the probability that time to confirmed EDSS progression is ≥ t) are identical for both treatment arms for some points in time t\>0.||||0.1768
71022666|NCT00185211|141553369|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.764||||0.1604||97.47|0.497|1.174|||Regression, Cox|The variable used as additional covariate adjustment was volume of T2 lesions on screening MRI.|The direction of comparison is initial IFNB-1b (numerator) versus initial placebo (denominator), i.e. the Hazard Ratio represents the relative risk of initial IFNB-1b treatment compared to initial placebo treatment.|Time to confirmed EDSS progression was modelled by a Cox proportional hazards regression model with the following covariates: treatment group and volume of T2 lesions on screening MRI. The null hypothesis was: Initial IFNB-1b and initial placebo do not differ with regard to the hazard for confirmed EDSS progression, i.e. hazard ratio = 1.||1.174|0.497|0.1604
71107629|NCT00565409|141721033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.98|||<|0.0001|TWO_SIDED|95.0|1.9|4.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||4.6|1.9|<0.0001
70933801|NCT02434328|141368955|OTHER||Difference in proportions|-3.5|||||TWO_SIDED|95.0|-9.9|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||3.1|-9.9|
70933802|NCT02434328|141368955|OTHER||Difference in proportions|-4.1|||||TWO_SIDED|95.0|-10.2|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||2.3|-10.2|
71022667|NCT00185211|141553370|SUPERIORITY_OR_OTHER|||||||0.888||95.0||||A 2-sided error level of 0.0253 was used for analyses at month 36 and 60 in order to keep the study-wise error level at 0.05. A conditional sequential testing approach was used for the family of null hypotheses of the primary efficacy variables.|non-parametric ANCOVA|Variable used as covariate: FAMS TOI measured at baseline||"The null hypothesis H0: The distribution of FAMS TOI at month 60, adjusted for baseline FAMS TOI, is identical for both treatment arms was tested against the alternative hypothesis HA: The distribution of FAMS TOI at month 60, adjusted for baseline FAMS TOI, is not the same in the two treatment arms using a non-parametric analysis of covariance (ANCOVA)."||||0.8880
71022668|NCT00185211|141553370|SUPERIORITY_OR_OTHER|||||||0.3832||95.0|||||ANCOVA|Variable used as covariate: FAMS TOI measured at baseline||"The null hypothesis H0: The mean FAMS TOI at month 60, adjusted for baseline FAMS TOI, is identical for both treatment arms was tested against the alternative hypothesis HA: The mean FAMS TOI at month 60, adjusted for baseline FAMS TOI, is not the same in the two treatment arms using a parametric analysis of covariance (ANCOVA)."||||0.3832
71022669|NCT00185211|141553371|SUPERIORITY_OR_OTHER|||||||6e-06||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|Log Rank|||"The null hypothesis for comparison of initial IFNB-1b versus initial placebo treatment was:~H0: The survival functions (i.e., the probability that time to McDonald MS is ≥ t) are identical for both treatment arms for all points in time t\>0.~The two-sided alternative hypothesis was:~H1: The survival functions (i.e., the probability that time to McDonald MS is ≥ t) are not identical for both treatment arms for some points in time t\>0."||||0.000006
71022670|NCT00185211|141553371|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.583|||<|1e-06||95.0|0.474|0.718|||Regression, Cox|covariate adjustment: steroid use during first event, onset of disease, categorized number of T2 lesions at screening|The direction of comparison is initial IFNB-1b versus initial placebo, i.e. the Hazard Ratio represents the relative risk of initial IFNB-1b treatment compared to initial placebo treatment.|Time to McDonald MS was modelled by a Cox proportional hazards regression model with the following covariates: treatment group, steroid use during first event (yes vs. no), onset of disease (monofocal vs. multifocal) and number of T2 lesions at screening (categories: 2-4, 5-8 and at least 9 T2 lesions). The null hypothesis was: Initial IFNB-1b and initial placebo do not differ with regard to the hazard for McDonald MS, i.e. hazard ratio = 1.||0.718|0.474|< 0.000001
71056087|NCT00261443|141616318|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.14||||0.378|TWO_SIDED|95.0|-0.46|0.17||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||0.17|-0.46|0.378
71056088|NCT00261443|141616318|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.12||||0.474|TWO_SIDED|95.0|-0.43|0.2||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||0.20|-0.43|0.474
71056089|NCT00261443|141616320|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.1||||0.488|TWO_SIDED|95.0|-0.19|0.4||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.40|-0.19|0.488
71056090|NCT00261443|141616320|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.15||||0.349|TWO_SIDED|95.0|-0.46|0.16||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.16|-0.46|0.349
71056091|NCT00261443|141616320|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.07||||0.653|TWO_SIDED|95.0|-0.39|0.25||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.25|-0.39|0.653
71056092|NCT00261443|141616320|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.24||||0.141|TWO_SIDED|95.0|-0.56|0.08||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.08|-0.56|0.141
71056093|NCT00261443|141616320|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.22||||0.196|TWO_SIDED|95.0|-0.54|0.11||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.11|-0.54|0.196
70933803|NCT02434328|141368955|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.8|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.0|-8.8|
70933804|NCT02434328|141368955|OTHER||Difference in proportions|-2.6|||||TWO_SIDED|95.0|-9.0|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||3.5|-9.0|
70933805|NCT02434328|141368955|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-9.9|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||2.8|-9.9|
71056094|NCT00261443|141616320|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.088|TWO_SIDED|95.0|-0.62|0.04||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||0.04|-0.62|0.088
71056095|NCT00261443|141616320|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.34||||0.047|TWO_SIDED|95.0|-0.68|-0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||-0.01|-0.68|0.047
71056096|NCT00261443|141616320|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.33||||0.057|TWO_SIDED|95.0|-0.67|0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||0.01|-0.67|0.057
71056097|NCT00261443|141616320|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.33||||0.063|TWO_SIDED|95.0|-0.68|0.02||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||0.02|-0.68|0.063
71056098|NCT00261443|141616320|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.3||||0.091|TWO_SIDED|95.0|-0.65|0.05||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||0.05|-0.65|0.091
71056099|NCT00261443|141616320|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.105|TWO_SIDED|95.0|-0.64|0.06||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||0.06|-0.64|0.105
71056100|NCT00261443|141616320|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.36||||0.047|TWO_SIDED|95.0|-0.72|-0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||-0.01|-0.72|0.047
71056101|NCT00261443|141616320|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.33||||0.073|TWO_SIDED|95.0|-0.69|0.03||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||0.03|-0.69|0.073
71056102|NCT00261443|141616321|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.0||||0.91|TWO_SIDED|95.0|0.92|1.08||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 4||1.08|0.92|0.910
71056103|NCT00261443|141616321|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.04||||0.3|TWO_SIDED|95.0|0.97|1.11||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 8||1.11|0.97|0.300
71056104|NCT00261443|141616321|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.01||||0.744|TWO_SIDED|95.0|0.95|1.08||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 12||1.08|0.95|0.744
71107630|NCT00565409|141721033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.59|||<|0.0001|TWO_SIDED|95.0|2.3|5.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||5.7|2.3|<0.0001
71107631|NCT00565409|141721033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.4509|TWO_SIDED|95.0|0.8|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||2.0|0.8|0.4509
70933806|NCT02434328|141368955|OTHER||Difference in proportions|-5.8|||||TWO_SIDED|95.0|-11.8|0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||0.3|-11.8|
70933807|NCT02434328|141368955|OTHER||Difference in proportions|-1.7|||||TWO_SIDED|95.0|-7.9|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||4.5|-7.9|
71056105|NCT00261443|141616321|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.09||||0.015|TWO_SIDED|95.0|1.02|1.17||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 16||1.17|1.02|0.015
71056106|NCT00261443|141616321|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.05||||0.264|TWO_SIDED|95.0|0.97|1.14||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 20||1.14|0.97|0.264
71056107|NCT00261443|141616321|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.05||||0.09|TWO_SIDED|95.0|0.99|1.11||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 24||1.11|0.99|0.090
71056108|NCT00261443|141616321|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.08||||0.056|TWO_SIDED|95.0|1.0|1.17||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 28||1.17|1.00|0.056
71056109|NCT00261443|141616321|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|0.99||||0.756|TWO_SIDED|95.0|0.93|1.05||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 32||1.05|0.93|0.756
71056110|NCT00261443|141616321|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.05||||0.177|TWO_SIDED|95.0|0.98|1.13||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 36||1.13|0.98|0.177
71056111|NCT00261443|141616321|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.07||||0.021|TWO_SIDED|95.0|1.01|1.13||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 40||1.13|1.01|0.021
71056112|NCT00261443|141616321|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.06||||0.216|TWO_SIDED|95.0|0.96|1.16||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 44||1.16|0.96|0.216
71056113|NCT00261443|141616321|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.07||||0.017|TWO_SIDED|95.0|1.01|1.15||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 48||1.15|1.01|0.017
71056114|NCT00261443|141616321|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.06||||0.083|TWO_SIDED|95.0|0.99|1.13||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 52||1.13|0.99|0.083
71056115|NCT00261443|141616322|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.78||||0.132|TWO_SIDED|95.0|0.56|1.08|||Stratified Log Rank Test|Stratified Log Rank Test p-value for equality of survival curves.||||1.08|0.56|0.132
71056116|NCT00261443|141616363|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.640
71056117|NCT00261443|141616363|SUPERIORITY_OR_OTHER_LEGACY|||||||0.423||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.423
71056118|NCT00261443|141616363|SUPERIORITY_OR_OTHER_LEGACY|||||||0.297||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.297
71056119|NCT00261443|141616363|SUPERIORITY_OR_OTHER_LEGACY|||||||0.707||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.707
71056120|NCT00261443|141616364|SUPERIORITY_OR_OTHER_LEGACY|||||||0.656||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.656
71056121|NCT00261443|141616364|SUPERIORITY_OR_OTHER_LEGACY|||||||0.045||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.045
71056122|NCT00261443|141616364|SUPERIORITY_OR_OTHER_LEGACY|||||||0.532||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.532
71056123|NCT00261443|141616364|SUPERIORITY_OR_OTHER_LEGACY|||||||0.578||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.578
71056124|NCT00261443|141616365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.619||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.619
71056125|NCT00261443|141616365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.868||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.868
71056126|NCT00261443|141616365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.284||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.284
71022671|NCT00185211|141553372|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.797||||0.1265||95.0|0.595|1.066||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|Andersen-Gill Model|Covariate adjustment: steroid use during first event, onset of disease, categorized number of T2 lesions at screening|The direction of comparison is initial IFNB-1b (numerator) versus initial placebo (denominator), i.e. the Hazard Ratio represents the relative risk of initial IFNB-1b treatment compared to initial placebo treatment.|The time to recurrent relapses was modelled by an extension of Cox's PH regression model (Andersen-Gill Model) for recurrent events with the following covariates: treatment group, steroid use during first event (yes vs. no), onset of disease (monofocal vs. multifocal) and number of T2 lesions at screening (2-4, 5-8 and at least 9 T2 lesions). The null hypothesis was: Initial IFNB-1b and initial placebo do not differ with regard to the hazard for recurrent relapses, i.e. hazard ratio = 1.||1.066|0.595|0.1265
71022672|NCT00185211|141553373|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7971||||0.0141||95.0|0.665|0.9554||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|generalized linear Poisson regression|covariate adjustment: steroid use during first event, onset of disease, categorized number of T2 lesions at screening|The direction of comparison is initial IFNB-1b (numerator) versus initial placebo (denominator), i.e. the Risk Ratio represents the relative risk of initial IFNB-1b treatment compared to initial placebo treatment.|Relapse rate was analyzed by a generalized linear Poisson regression model with individual relapse counts as dependent variable, covariates: treatment arm, steroid use during first event, onset of disease and categorized number of T2 lesions at screening and offset variable natural log of time (in years) as difference between last clinical visit and baseline visit. The treatment effect on the relapse rate was of primary interest.||0.9554|0.6650|0.0141
71022673|NCT00185211|141553374|SUPERIORITY_OR_OTHER|||||||0.6078||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|non-parametric ANCOVA|Variable used as covariate: MSFC Z-scores measured at baseline||"The null hypothesis H0: The distribution of MSFC Z-scores at month 60 adjusted for baseline MSFC Z-score is identical for both treatment arms was tested against the alternative hypothesis HA: The distribution of MSFC Z-scores at month 60 adjusted for baseline MSFC Z-score is not the same in the two treatment groups based on a non-parametric analysis of covariance (ANCOVA)."||||0.6078
71022674|NCT00185211|141553374|SUPERIORITY_OR_OTHER|||||||0.8245||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|ANCOVA|Variable used as covariate: MSFC Z-scores measured at baseline||"The null hypothesis H0: The mean MSFC Z-scores at month 60 adjusted for baseline MSFC Z-score are identical for both treatment arms was tested against the alternative hypothesis HA: The mean MSFC Z-scores at month 60 adjusted for baseline MSFC Z-score are not the same in the two treatment groups based on a non-parametric analysis of covariance (ANCOVA)."||||0.8245
71022675|NCT00185211|141553375|SUPERIORITY_OR_OTHER|||||||0.0062||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|non-parametric ANCOVA|Variable used as covariate: number of Gd-enhancing lesions on T1 at screening||"The null hypothesis H0: The distribution of the cumulative number of newly active lesions at month 60 adjusted for the number of Gadolinium (Gd)-enhancing lesions on T1 at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a non-parametric analysis of covariance (ANCOVA)."||||0.0062
71022676|NCT00185211|141553375|SUPERIORITY_OR_OTHER||Relative effect size|0.7351||||0.0435||95.0|0.5436|0.994||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|generalized linear model|Distribution: negative binomial distribution; covariate: number of Gd-enhancing lesions on T1 at screening|The direction of comparison is initial IFNB-1b versus initial placebo.|Assuming that the cumulative number of newly active lesions at month 60 follows a negative binomial distribution, a generalized linear model (logarithmic link function, covariate: number of Gd-enhancing lesions on T1 at BENEFIT screening) was set up in order to analyze the treatment effect on that MRI outcome.||0.9940|0.5436|0.0435
71022677|NCT00185211|141553376|SUPERIORITY_OR_OTHER|||||||0.7801||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|non-parametric ANCOVA|Variable used as covariate: T2 lesion volume at screening||"The null hypothesis H0: The distribution of the absolute change of T2 lesion volume at month 60 adjusted for the T2 lesion volume at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a non-parametric analysis of covariance (ANCOVA)."||||0.7801
71022678|NCT00185211|141553376|SUPERIORITY_OR_OTHER|||||||0.9408||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|ANCOVA|Variable used as covariate: T2 lesion volume at screening||"The null hypothesis H0: The mean absolute change of T2 lesion volume at month 60 adjusted for the T2 lesion volume at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a parametric analysis of covariance (ANCOVA)."||||0.9408
71022679|NCT00185211|141553377|SUPERIORITY_OR_OTHER|||||||0.6619||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|non-parametric ANCOVA|Variable used as covariate: Volume of black holes at screening||"The null hypothesis H0: The distribution of the absolute change of volume of black holes at month 60 adjusted for the volume of black holes at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a non-parametric analysis of covariance (ANCOVA)."||||0.6619
71022680|NCT00185211|141553377|SUPERIORITY_OR_OTHER|||||||0.8558||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|ANCOVA|Variable used as covariate: Volume of black holes at screening||"The null hypothesis H0: The mean absolute change of volume of black holes at month 60 adjusted for the volume of black holes at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a parametric analysis of covariance (ANCOVA)."||||0.8558
71056127|NCT00261443|141616365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.481||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.481
71056128|NCT00261443|141616366|SUPERIORITY_OR_OTHER_LEGACY|||||||0.184||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.184
71022681|NCT00185211|141553378|SUPERIORITY_OR_OTHER|||||||0.1208||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|non-parametric ANCOVA|Variable used as covariate: Brain volume at screening||"The null hypothesis H0: The distribution of the percentage change of brain volume at month 60 adjusted for the brain volume at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a non-parametric analysis of covariance (ANCOVA)."||||0.1208
71022682|NCT00185211|141553378|SUPERIORITY_OR_OTHER|||||||0.0719||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|ANCOVA|Variable used as covariate: Brain volume at screening||"The null hypothesis H0: The mean percentage change of brain volume at month 60 adjusted for the brain volume at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a parametric analysis of covariance (ANCOVA)."||||0.0719
70933808|NCT02434328|141368955|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.8|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.1|-8.8|
71022683|NCT02544633|141553416|SUPERIORITY|An exact test for single proportion (two-sided a=5%) will be performed to test H0: ORR \<=20% against H1: ORR \>20%.|Objective response rate|10.7||||0.94|TWO_SIDED|95.0|2.27|28.23|||exact test|||||28.23|2.27|0.94
71022684|NCT02544633|141553416|SUPERIORITY||Objective response rate|15.0||||0.79|TWO_SIDED|95.0|3.21|37.89|||exact test|||||37.89|3.21|0.79
71022685|NCT02544633|141553416|SUPERIORITY||Objective response rate|25.0||||0.47|TWO_SIDED|95.0|3.19|65.09|||Exact Test|||||65.09|3.19|0.47
71022686|NCT02544633|141553416|SUPERIORITY||Objective response rate|0.0|||>|0.999|TWO_SIDED|95.0|0.0|26.46|||Exact test|||||26.46|0.00|>0.999
71022687|NCT02257632|141553443|SUPERIORITY||Mean Difference (Final Values)|-14.98|||<|0.0001|TWO_SIDED|95.0|-19.64|-10.32||missing Baseline VEGF-A level covariate values were imputed by the mean value of non-missing Baseline VEGF-A level from all other patients|ANCOVA|including treatment group and center as fixed effect factors and Baseline VEGF-A as a covariate||||-10.32|-19.64|<0.0001
71022688|NCT02257632|141553444|SUPERIORITY||Mean Difference (Final Values)|-11.46|||<|0.0001|TWO_SIDED|95.0|-15.98|-6.94||missing Baseline VEGF-A level covariate values were imputed by the mean value of non-missing Baseline VEGF-A level from all the patients with values|ANCOVA|including treatment group and center as fixed effect factors and Baseline VEGF-A as a covariate||||-6.94|-15.98|< 0.0001
71022689|NCT00936884|141553458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|83.6|||<|0.0001|TWO_SIDED|97.5|6.5|1074.7||Comparison of the MNTX group and the placebo group in the proportion of subjects having a RFBM within 4 hours after the first injection was performed by using a 2-sided Cochran-Mantel-Haenszel Chi square test at the alpha level of 0.025.|Chi-squared|||||1074.7|6.50|<0.0001
71022690|NCT00936884|141553459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|56.64|||<|0.0001|TWO_SIDED|97.5|40.62|72.66||Comparison of the MNTX group and the placebo group was based on ANOVA model with the proportion of injections resulting in RFBM within 4 hours during the double-blind period as the dependent variable and the treatment group as the fixed effect. .|ANOVA||Estimated value is the difference in least squared means for MNTX vs. placebo (MNTX minus placebo). Based on the ANOVA model, there is 97.5% confidence that the difference between MNTX and placebo falls between the lower and upper limits presented.|||72.66|40.62|<0.0001
71022691|NCT00936884|141553460|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|23.38|||<|0.0001|TWO_SIDED|97.5|10.91|50.14||Comparison of the MNTX group and the placebo group in the proportion of subjects having a RFBM within 4 hours after each injection was performed by using a 2-sided Cochran-Mantel-Haenszel Chi square test at the alpha level of 0.025.|Chi-squared|||||50.14|10.91|< 0.0001
71022692|NCT01859390|141553494|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.46|TWO_SIDED|95.0|-0.49|0.22|||t-test, 2 sided|||Two-sample T-test||0.22|-0.49|0.460
71022693|NCT01859390|141553494|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.325|TWO_SIDED|95.0|-0.513|0.173|||Regression, Linear||"Regression Model predictors include: AquADEKs-2 arm, Age \>=18 years, Sex, Screening FEV1%Predicted \>70%, Chronic use of Inhaled Antibiotics and Azithromycin.~The estimated value is the mean difference between groups for 16 week change in log10 MPO."|||0.173|-0.513|0.325
71022694|NCT01859390|141553495|SUPERIORITY||Difference in Proportions-SAE incidence|-12.9||||0.302|TWO_SIDED|95.0|-32.1|7.8|||Fisher Exact|||||7.8|-32.1|0.302
71022695|NCT01859390|141553496|SUPERIORITY||Rate Ratio|0.94||||0.486|TWO_SIDED|95.0|0.78|1.13|||Poisson Model|||Rate Ratio for Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks in the AquADEKs-2 group was 642 and in the Control group was 639.||1.13|0.78|0.486
71022696|NCT01859390|141553496|SUPERIORITY|Rate Ratio for Serious Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks in the AquADEKs-2 group was 642 and in the Control group was 639.|Rate Ratio|0.74||||0.269|TWO_SIDED|95.0|0.43|1.26|||Poisson Regression|||||1.26|0.43|0.269
71022697|NCT01859390|141553497|SUPERIORITY|Two sample T-test|Median Difference (Final Values)|1.43||||0.4463|TWO_SIDED|95.0|-2.3|5.16|||t-test, 2 sided|||||5.16|-2.30|0.4463
71022698|NCT01859390|141553498|SUPERIORITY||Median Difference (Final Values)|0.04||||0.8623|TWO_SIDED|95.0|-0.37|0.44|||t-test, 2 sided|||||0.44|-0.37|0.8623
71022699|NCT01859390|141553499|SUPERIORITY||Cox Proportional Hazard|0.536||||0.0534|TWO_SIDED|95.0|0.284|1.009||Not adjusted for multiple comparisons. Alpha at 0.05.|Regression, Cox||"Cox model parameters include: AquADEKs-2 arm, Age \>=18 years, Sex, Screening FEV1 % Predicted \>70%, Chronic use of Inhaled Antibiotics and Azithromycin.~The parameter of interest is the Hazard Ratio comparing the AquADEKs-2 arm to the control arm."|||1.009|0.284|0.0534
71022700|NCT01859390|141553500|SUPERIORITY||Rate Ratio|0.72||||0.1731|TWO_SIDED|95.0|0.44|1.16|||Poisson Model|||Rate Ratio for PEx calculated using Poisson Regression with an offset for the log of follow-up time in months. The total number of follow-up months in the AquADEKs-2 group was 148 and in the Control group was 147.||1.16|0.44|0.1731
71022701|NCT01859390|141553501|SUPERIORITY|Difference in Proportions|Mean Difference (Final Values)|-14.8||||0.2363|TWO_SIDED|95.0|-35.1|7.4||Not adjusted for multiple comparisons. Alpha at 0.05.|Fisher Exact|||||7.4|-35.1|0.2363
71022702|NCT01859390|141553502|SUPERIORITY|Difference in Proportions|Median Difference (Final Values)|-15.7||||0.19|TWO_SIDED|95.0|-34.5|4.8|||Fisher Exact|||||4.8|-34.5|0.1900
70933809|NCT02434328|141368956|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-7.6|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.8|-7.6|
70933810|NCT02434328|141368956|OTHER||Difference in proportions|-6.0|||||TWO_SIDED|95.0|-13.0|0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||0.1|-13.0|
70933811|NCT02434328|141368956|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-10.1|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.4|-10.1|
70933812|NCT02434328|141368956|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-7.3|6.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||6.3|-7.3|
71022703|NCT01275313|141553515|EQUIVALENCE|Power calculation: To determine a difference of 20% in the control group and 10% in the treatment group with 80% power, 440 participants would be needed.||||||0.77|||||||Chi-squared, Corrected|||Null hypothesis: At-risk nursing home residents provided with an individually-configured manual lightweight wheelchair and skin protection cushion have the same incidence of pressure injury development compared to individuals using a facility-provided manual wheelchair modified with a skin protection cushion and related adjustments.||||0.77
70933813|NCT02434328|141368956|OTHER||Difference in proportions|-4.6|||||TWO_SIDED|95.0|-11.2|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||2.2|-11.2|
70933814|NCT02434328|141368956|OTHER||Difference in proportions|-3.7|||||TWO_SIDED|95.0|-10.7|3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||3.0|-10.7|
70933815|NCT02434328|141368956|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-9.6|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||4.0|-9.6|
71022704|NCT02965820|141553528|SUPERIORITY||||||=|0.003|||||||Mixed Models Analysis|||||||=0.0030
71022705|NCT01967888|141553529|SUPERIORITY||t-test|-1.2||||0.542|TWO_SIDED|95.0|-14.3|0.0|||Cochran-Mantel-Haenszel|||||000|-14.3|0.542
71056129|NCT00261443|141616366|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.073
71056130|NCT00261443|141616366|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.020
71056131|NCT00261443|141616366|SUPERIORITY_OR_OTHER_LEGACY|||||||0.206||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.206
71056132|NCT00261443|141616367|SUPERIORITY_OR_OTHER_LEGACY|||||||0.142||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.142
71056133|NCT00261443|141616367|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.110
71056134|NCT00261443|141616367|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.022
71056135|NCT00261443|141616367|SUPERIORITY_OR_OTHER_LEGACY|||||||0.542||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.542
71022706|NCT01967888|141553530|SUPERIORITY||least square mean difference|-0.1601778||||0.092|TWO_SIDED|95.0|-0.317803|-0.0025525|||t-test, 2 sided|||||-0.0025525|-0.3178030|0.092
71022707|NCT01967888|141553531|SUPERIORITY||least square mean difference|-0.1178242||||0.161|TWO_SIDED|95.0|-0.287431|0.0517825|||t-test, 2 sided|||||0.0517825|-0.2874310|0.161
71022708|NCT01967888|141553532|SUPERIORITY||least square mean difference|0.0136||||0.846|TWO_SIDED|95.0|-0.0508|0.0781|||t-test, 2 sided|||||0.0781|-0.0508|0.846
71056136|NCT00261443|141616368|SUPERIORITY_OR_OTHER_LEGACY|||||||0.916||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.916
71056137|NCT00261443|141616368|SUPERIORITY_OR_OTHER_LEGACY|||||||0.707||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.707
71056138|NCT00261443|141616368|SUPERIORITY_OR_OTHER_LEGACY|||||||0.665||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.665
71056139|NCT00261443|141616368|SUPERIORITY_OR_OTHER_LEGACY|||||||0.757||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.757
71056140|NCT00261443|141616369|SUPERIORITY_OR_OTHER_LEGACY|||||||0.871||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.871
71056141|NCT00261443|141616369|SUPERIORITY_OR_OTHER_LEGACY|||||||0.362||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.362
71056142|NCT00261443|141616369|SUPERIORITY_OR_OTHER_LEGACY|||||||0.295||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.295
71056143|NCT00261443|141616369|SUPERIORITY_OR_OTHER_LEGACY|||||||0.519||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.519
71056144|NCT00261443|141616370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.935||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.935
71056145|NCT00261443|141616370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.174||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.174
71056146|NCT00261443|141616370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.527||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.527
71022709|NCT01967888|141553533|SUPERIORITY||least square mean difference|-0.025||||0.817|TWO_SIDED|95.0|-0.0939|0.0689|||t-test, 2 sided|||||0.0689|-0.0939|0.817
71022710|NCT01967888|141553534|SUPERIORITY||least square mean difference|-9.4641||||0.57|TWO_SIDED|95.0|-42.49|23.5618|||Mixed Models Analysis|||||23.5618|-42.4900|0.570
71022711|NCT01967888|141553535|SUPERIORITY||least square mean difference|-22.9454|||=|0.074|TWO_SIDED|95.0|-48.1826|2.2918|||Mixed Models Analysis|||||2.2918|-48.1826|=0.074
71022712|NCT01967888|141553536|SUPERIORITY||least square mean difference|-0.2074|||=|0.358|TWO_SIDED|95.0|-0.6538|0.2389|||Mixed Models Analysis|||||0.2389|-0.6538|=0.358
71022713|NCT01967888|141553537|SUPERIORITY||least square mean difference|-0.277|||=|0.288|TWO_SIDED|95.0|-0.7936|0.2396|||Mixed Models Analysis|||||0.2396|-0.7936|=0.288
71022714|NCT01967888|141553538|SUPERIORITY||least square mean difference|0.09716|||=|0.98|TWO_SIDED|95.0|-7.41834|7.61266|||Mixed Models Analysis|||||7.61266|-7.41834|=0.980
71022715|NCT01967888|141553539|SUPERIORITY||least square mean difference|1.07617|||=|0.785|TWO_SIDED|95.0|-6.76562|8.91796|||Mixed Models Analysis|||||8.91796|-6.76562|=0.785
71022716|NCT01967888|141553540|SUPERIORITY|||||||0.176|||||||Wilcoxon (Mann-Whitney)|||||||0.176
71022717|NCT01967888|141553541|SUPERIORITY|||||||0.403|||||||Wilcoxon (Mann-Whitney)|||||||0.403
71022718|NCT01967888|141553542|SUPERIORITY||Treatment effect|2.1||||0.842|TWO_SIDED|95.0|-18.2|22.33|||Chi-squared|||||22.33|-18.20|0.842
71022719|NCT01967888|141553543|SUPERIORITY||Hazard Ratio (HR)|3.21||||0.339|TWO_SIDED|95.0|0.29|34.97|||Anderson-Gill model|||||34.97|0.29|0.339
71022720|NCT01967888|141553544|SUPERIORITY||Treatment effect|5.0||||0.64|TWO_SIDED|95.0|-15.91|25.93|||Chi-squared|||||25.93|-15.91|0.640
71022721|NCT01967888|141553550|SUPERIORITY|||||||0.448|||||||Wilcoxon rank-sum test|||||||0.448
71022722|NCT01967888|141553551|SUPERIORITY|||||||0.91|||||||Wilcoxon rank-sum test|||||||0.910
71022723|NCT01967888|141553552|SUPERIORITY|||||||1|||||||Wilcoxon rank-sum test|||||||1.000
71056147|NCT00261443|141616370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.753||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.753
71056148|NCT00261443|141616371|SUPERIORITY_OR_OTHER_LEGACY|||||||0.85||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.850
71022724|NCT01967888|141553557|SUPERIORITY||least square mean difference|31.3491|||=|0.5018|TWO_SIDED|95.0|-60.998|123.7|||Mixed Models Analysis|||||123.70|-60.9980|=0.5018
71022725|NCT01967888|141553558|SUPERIORITY||Least square mean difference|23.5454|||=|0.4537|TWO_SIDED|95.0|-38.6619|85.7528|||Mixed Models Analysis|||||85.7528|-38.6619|=0.4537
71022726|NCT01859325|141553607|SUPERIORITY||Median Difference (Final Values)|-0.36||||0.406|TWO_SIDED|95.0|-1.41|0.67|||Wilcoxon (Mann-Whitney)|||Samples size based on published data on populations of early treated patients undergoing ART interruption. The power based on a 2-sample t-test with a 2-tailed alpha of .05 and a total sample size of 30 is approximately 91% to detect a 1.25 log10 reduction in the rebound plasma viremia between vaccine and placebo groups.||0.67|-1.41|0.406
71056149|NCT00261443|141616371|SUPERIORITY_OR_OTHER_LEGACY|||||||0.709||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.709
71056150|NCT00261443|141616371|SUPERIORITY_OR_OTHER_LEGACY|||||||0.326||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.326
71022727|NCT03840135|141553618|SUPERIORITY||Mean Difference (Final Values)|-0.22|||<|0.05|TWO_SIDED|95.0|-0.6|0.16|||t-test, 2 sided|||The value of δ = -0.52 days was considered as the boundary of superiority. The end of the fever period is considered to have an axillary body temperature of ≤36.9 ° C in two consecutive measurements (morning-evening / evening-morning).||0.16|-0.6|<0.05
71022728|NCT03840135|141553619|SUPERIORITY||||||<|0.05|||||||χ2 Pearson criterion|||||||<0.05
71056151|NCT00261443|141616371|SUPERIORITY_OR_OTHER_LEGACY|||||||0.201||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.201
71056152|NCT00261443|141616372|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.47||||0.491|TWO_SIDED|95.0|-0.87|1.81||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 (LOCF) Treatment Difference||1.81|-0.87|0.491
71056153|NCT00261443|141616372|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04||||0.945|TWO_SIDED|95.0|-1.21|1.12||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value Treatment Difference||1.12|-1.21|0.945
71056154|NCT00261443|141616373|SUPERIORITY_OR_OTHER_LEGACY|||||||0.279||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 12 Treatment Comparison||||0.279
71022729|NCT03840135|141553620|SUPERIORITY||||||<|0.05|||||||χ2 Pearson criterion|||||||<0.05
71022730|NCT03840135|141553621|SUPERIORITY||||||<|0.05|||||||χ2 Pearson criterion|||||||<0.05
71022731|NCT03840135|141553622|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71022732|NCT03840135|141553623|SUPERIORITY||||||<|0.05|||||||χ2 Pearson criterion|||||||<0.05
71022733|NCT03840135|141553624|SUPERIORITY||||||<|0.05|||||||χ2 Pearson criterion|||||||<0.05
71022734|NCT03840135|141553627|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
71022735|NCT03840135|141553628|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
71022736|NCT01827371|141553636|NON_INFERIORITY_OR_EQUIVALENCE|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|1.32|||||TWO_SIDED|98.33|0.72|1.93||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm B)) ≥ 1 or GMT(Arm A)/GMT (Arm B) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm B)) \< 1 or GMT(Arm A)/GMT(Arm B) \< 2.~Sample Size: The SD for log2 PRNT based on a prior study was\~1.9. The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used. Power=80%"||1.93|0.72|
71022737|NCT01827371|141553636|NON_INFERIORITY_OR_EQUIVALENCE|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|0.86|||||TWO_SIDED|98.33|0.26|1.47||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm C)) ≥ 1 or GMT(Arm A)/GMT (Arm C) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm C)) \< 1 or GMT(Arm A)/GMT(Arm C) \< 2.~Sample Size: The SD for log2 PRNT based on a prior study was\~1.9. The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used. Power=80%"||1.47|0.26|
71022738|NCT01827371|141553636|NON_INFERIORITY_OR_EQUIVALENCE|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|0.41|||||TWO_SIDED|98.33|-0.17|1.0007||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm D)) ≥ 1 or GMT(Arm A)/GMT (Arm D) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm D)) \< 1 or GMT(Arm A)/GMT(Arm D) \< 2.~Sample Size: The SD for log2 PRNT based on a prior study was\~1.9. The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used. Power=80%"||1.0007|-0.17|
71022739|NCT01827371|141553637|SUPERIORITY_OR_OTHER|||||||0.4782|TWO_SIDED|||||alpha= 5%|Fisher Exact|||"Hypothesis:~H0: Pr('Pain at Injection Site ' Arm A) = Pr('Pain at Injection Site ' Arm D) H1: Pr('Pain at Injection Site ' Arm A) not = Pr('Pain at Injection Site ' Arm D)"||||0.4782
70933816|NCT02434328|141368956|OTHER||Difference in proportions|-2.6|||||TWO_SIDED|95.0|-9.4|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.5|-9.4|
70933817|NCT02434328|141368956|OTHER||Difference in proportions|-5.4|||||TWO_SIDED|95.0|-12.1|1.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||1.1|-12.1|
70933818|NCT02434328|141368956|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-9.9|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||3.5|-9.9|
70941667|NCT04748445|141383934|OTHER||Slope|0.004403|STANDARD_ERROR_OF_MEAN|1.503||0.7701|TWO_SIDED|90.0|-0.02051|0.02931|||Mixed Models Analysis|||MM\_MFCC std 03 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.02931|-0.02051|0.7701
71022740|NCT01827371|141553637|SUPERIORITY_OR_OTHER|||||||0.1704|TWO_SIDED|||||alpha= 5%|Fisher Exact|||"Hypothesis:~H0: Pr('Itchiness at Injection Site' Arm A) = Pr('Itchiness at Injection Site' Arm D) H1: Pr('Itchiness at Injection Site' Arm A) not = Pr('Itchiness at Injection Site' Arm D)"||||0.1704
71022741|NCT01827371|141553637|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||alpha= 5%|Fisher Exact|||"Hypothesis:~H0: Pr('Underarm pain' Arm A) = Pr('Underarm pain' Arm D) H1: Pr('Underarm pain' Arm A) not = Pr('Underarm pain' Arm D)"||||1.000
71022742|NCT01827371|141553637|SUPERIORITY_OR_OTHER|||||||0.6171|TWO_SIDED|||||alpha= 5%|Fisher Exact|||"Hypothesis:~H0: Pr('Underarm swelling' Arm A) = Pr('Underarm swelling' Arm D) H1: Pr('Underarm swelling' Arm A) not = Pr('Underarm swelling' Arm D)"||||0.6171
71022743|NCT01827371|141553637|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||alpha=5%|Fisher Exact|||"Hypothesis:~H0: Pr('Redness at Injection Site' Arm A) = Pr('Redness at Injection Site' Arm D) H1: Pr('Redness at Injection Site' Arm A) not = Pr('Redness at Injection Site' Arm D)"||||<0.0001
71022744|NCT01827371|141553637|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||alpha=5%|Fisher Exact|||"Hypothesis:~H0: Pr('Swelling at Injection Site' Arm A) = Pr('Swelling at Injection Site' Arm D) H1: Pr('Swelling at Injection Site' Arm A) not = Pr('Swelling at Injection Site' Arm D)"||||0.0050
71022745|NCT01827371|141553637|SUPERIORITY_OR_OTHER|||||||0.0012|TWO_SIDED|||||alpha=5%|Fisher Exact|||"Hypothesis:~H0: Pr('Any Solicited Local Reaction' Arm A) = Pr('Any Solicited Local Reaction' Arm D) H1: Pr('Any Solicited Local Reaction' Arm A) not = Pr('Any Solicited Local Reaction' Arm D)"||||0.0012
71022746|NCT01827371|141553638|NON_INFERIORITY_OR_EQUIVALENCE|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|0.76|||||TWO_SIDED|98.33|0.37|1.15||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm B)) ≥ 1 or GMT(Arm A)/GMT (Arm B) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm B)) \< 1 or GMT(Arm A)/GMT(Arm B) \< 2.~The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used."||1.15|0.37|
71056155|NCT00261443|141616373|SUPERIORITY_OR_OTHER_LEGACY|||||||0.247||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 24 Treatment Comparison||||0.247
71056156|NCT00261443|141616373|SUPERIORITY_OR_OTHER_LEGACY|||||||0.329||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 36 Treatment Comparison||||0.329
71056157|NCT00261443|141616373|SUPERIORITY_OR_OTHER_LEGACY|||||||0.928||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 52 Treatment Comparison||||0.928
70933819|NCT02434328|141368956|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-10.3|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.2|-10.3|
70933820|NCT02434328|141368956|OTHER||Difference in proportions|-1.9|||||TWO_SIDED|95.0|-8.7|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||4.7|-8.7|
71022747|NCT01827371|141553638|NON_INFERIORITY_OR_EQUIVALENCE|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|0.3|||||TWO_SIDED|98.33|-0.06|0.67||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm C)) ≥ 1 or GMT(Arm A)/GMT (Arm C) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm C)) \< 1 or GMT(Arm A)/GMT(Arm C) \< 2.~The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used."||0.67|-0.06|
71022748|NCT01827371|141553638|NON_INFERIORITY_OR_EQUIVALENCE|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|-0.1|||||TWO_SIDED|98.33|-0.5|0.3||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm D)) ≥ 1 or GMT(Arm A)/GMT (Arm D) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm D)) \< 1 or GMT(Arm A)/GMT(Arm D) \< 2.~The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used."||0.30|-0.50|
71022749|NCT01361607|141553641|SUPERIORITY||Median Difference (Final Values)|-1.84||||0.2735|TWO_SIDED|95.0|-6.19|1.5|||Wilcoxon (Mann-Whitney)|||||1.50|-6.19|0.2735
71022750|NCT01809314|141553652|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||The difference between Baseline and Month 4 was analyzed using the Wilcoxon signed-rank test.||||<0.0001
71022751|NCT01809314|141553653|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon signed-rank test|||Overall (all categories combined) change from Baseline in ECOG performance status at Month 4 was analyzed using Wilcoxon signed-rank test.||||0.001
71022752|NCT00219557|141553660|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.758||||0.1026|TWO_SIDED|95.0|0.49|1.17||One-sided log-rank test at alpha = 0.1 significance level was used.|Log Rank|||Differences in OS between treatment arms was analyzed by the stratified log-rank test where the stratification factors are Eastern Cooperative Oncology Group (ECOG) performance status (less than or equal to 1 or 2) and extent of disease (locally advanced or metastatic).||1.170|0.490|0.1026
71022753|NCT00219557|141553671|SUPERIORITY_OR_OTHER||Difference in response rate|4.3||||0.661|TWO_SIDED|95.0|-4.0|12.7|||Fisher Exact|||Difference in percent of participants with overall response expressed as response rate, was used for calculation of 95% confidence interval (CI).||12.7|-4.0|0.661
71056158|NCT00261443|141616373|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.17||||0.584|TWO_SIDED|95.0|0.66|2.09||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 52 (LOCF) Treatment Comparison||2.09|0.66|0.584
71056159|NCT00261443|141616373|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.26||||0.369|TWO_SIDED|95.0|0.76|2.08||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||"At Any Time Treatment Comparison"||2.08|0.76|0.369
71056160|NCT00261443|141616374|SUPERIORITY_OR_OTHER_LEGACY|||||||0.685||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 12 Treatment Comparison||||0.685
71022754|NCT00219557|141553673|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9648||||0.4466|TWO_SIDED|95.0|0.54|1.73||One-sided log-rank test at alpha = 0.1 significance level was used.|Log Rank|||Differences in PFS between treatment arms was analyzed by the stratified log-rank test where the stratification factors are ECOG performance status (less than equal to 1 or 2) and extent of disease (locally advanced or metastatic).||1.7300|0.5400|0.4466
71022755|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.44|||||TWO_SIDED|95.0|-19.06|2.19||||||For change in global QoL at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||2.19|-19.06|
71022756|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.02|||||TWO_SIDED|95.0|-15.4|3.36||||||For change in physical functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||3.36|-15.4|
71022757|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.32|||||TWO_SIDED|95.0|-23.77|5.12||||||For change in role functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||5.12|-23.77|
71022758|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.73|||||TWO_SIDED|95.0|-15.25|5.79||||||For change in emotional functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||5.79|-15.25|
71022759|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.11|||||TWO_SIDED|95.0|-15.83|5.61||||||For change in cognitive functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||5.61|-15.83|
71056161|NCT00261443|141616374|SUPERIORITY_OR_OTHER_LEGACY|||||||0.792||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 24 Treatment Comparison||||0.792
71056162|NCT00261443|141616374|SUPERIORITY_OR_OTHER_LEGACY|||||||0.805||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 36 Treatment Comparison||||0.805
71056163|NCT00261443|141616374|SUPERIORITY_OR_OTHER_LEGACY|||||||0.533||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 52 Treatment Comparison||||0.533
71056164|NCT00261443|141616374|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.78||||0.545|TWO_SIDED|95.0|0.35|1.74||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 52 (LOCF) Treatment Comparison||1.74|0.35|0.545
71056165|NCT00261443|141616374|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.01||||0.987|TWO_SIDED|95.0|0.54|1.86||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||"At Any Time Treatment Comparison"||1.86|0.54|0.987
71056166|NCT00261443|141616375|SUPERIORITY_OR_OTHER_LEGACY|||||||0.646||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Treatment Comparison Baseline||||0.646
71056167|NCT00261443|141616375|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Week 12 Treatment Comparison||||0.006
71056168|NCT00261443|141616375|SUPERIORITY_OR_OTHER_LEGACY|||||||0.485||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Week 24 Treatment Comparison||||0.485
71056169|NCT00261443|141616375|SUPERIORITY_OR_OTHER_LEGACY|||||||0.325||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Week 36 Treatment Comparison||||0.325
71056170|NCT00261443|141616375|SUPERIORITY_OR_OTHER_LEGACY|||||||0.374||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Week 52 Treatment Comparison||||0.374
71056171|NCT00261443|141616375|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Week 52 (LOCF) Treatment Comparison||||0.064
71056172|NCT00261443|141616375|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Highest Value Treatment Comparison||||0.310
71056173|NCT00261443|141616375|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Lowest Value Treatment Comparison||||0.046
71056174|NCT00261443|141616377|SUPERIORITY_OR_OTHER_LEGACY|||||||0.331||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline ALP||||0.331
71056175|NCT00261443|141616377|SUPERIORITY_OR_OTHER_LEGACY|||||||0.353||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in ALP at Week 52 (LOCF)||||0.353
71056176|NCT00261443|141616377|SUPERIORITY_OR_OTHER_LEGACY|||||||0.298||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison ALP Highest Change Value During Phase 3||||0.298
71056177|NCT00261443|141616378|SUPERIORITY_OR_OTHER_LEGACY|||||||0.111||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline ALT||||0.111
71056178|NCT00261443|141616378|SUPERIORITY_OR_OTHER_LEGACY|||||||0.948||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change in ALT at Week 52 (LOCF)||||0.948
71056179|NCT00261443|141616378|SUPERIORITY_OR_OTHER_LEGACY|||||||0.559||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison ALT Highest Change Value During Phase 3||||0.559
71056180|NCT00261443|141616379|SUPERIORITY_OR_OTHER_LEGACY|||||||0.077||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline AST||||0.077
71056181|NCT00261443|141616379|SUPERIORITY_OR_OTHER_LEGACY|||||||0.255||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change in AST at Week 52 (LOCF)||||0.255
71056182|NCT00261443|141616379|SUPERIORITY_OR_OTHER_LEGACY|||||||0.918||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison AST Highest Change Value During Phase 3||||0.918
71056183|NCT00261443|141616380|SUPERIORITY_OR_OTHER_LEGACY|||||||0.118||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline BUN||||0.118
71056184|NCT00261443|141616380|SUPERIORITY_OR_OTHER_LEGACY|||||||0.532||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in BUN at Week 52 (LOCF)||||0.532
71056185|NCT00261443|141616380|SUPERIORITY_OR_OTHER_LEGACY|||||||0.169||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison BUN Highest Value of Change During Phase 3||||0.169
71056186|NCT00261443|141616381|SUPERIORITY_OR_OTHER_LEGACY|||||||0.878||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Total Cholesterol (fasting)||||0.878
71056187|NCT00261443|141616381|SUPERIORITY_OR_OTHER_LEGACY|||||||0.544||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Total Cholesterol (fasting) at Week 52 (LOCF)||||0.544
71056188|NCT00261443|141616381|SUPERIORITY_OR_OTHER_LEGACY|||||||0.658||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Total Cholesterol (fasting) in Phase 3||||0.658
71056189|NCT00261443|141616382|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Creatine Kinase||||0.043
71056190|NCT00261443|141616382|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from baseline in Creatine Kinase at Week 52 (LOCF)||||0.019
71056191|NCT00261443|141616382|SUPERIORITY_OR_OTHER_LEGACY|||||||0.176||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Creatine Kinase During Phase 3||||0.176
70933821|NCT02434328|141368956|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-8.0|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||5.7|-8.0|
70933822|NCT02434328|141368956|OTHER||Difference in proportions|-2.8|||||TWO_SIDED|95.0|-9.8|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||4.3|-9.8|
71107632|NCT00565409|141721033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.96|||<|0.0001|TWO_SIDED|95.0|1.9|4.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||4.6|1.9|<0.0001
70933823|NCT02434328|141368956|OTHER|Hypothesis testing not pre-specified.|Difference in proportions|-2.8|||||TWO_SIDED|95.0|-9.6|4.2|||Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||4.2|-9.6|
70933824|NCT02434328|141368956|OTHER||Difference in proportions|-1.7|||||TWO_SIDED|95.0|-8.8|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.4|-8.8|
71107633|NCT00565409|141721033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.28|||<|0.0001|TWO_SIDED|95.0|2.6|7.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||7.0|2.6|<0.0001
71107634|NCT00565409|141721033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.3037|TWO_SIDED|95.0|0.7|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||2.0|0.7|0.3037
71107635|NCT00565409|141721033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.27|||<|0.0001|TWO_SIDED|95.0|2.1|5.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||5.1|2.1|<0.0001
71107636|NCT00565409|141721033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.41|||<|0.0001|TWO_SIDED|95.0|2.7|7.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||7.2|2.7|<0.0001
71107637|NCT00565409|141721033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13||||0.6076|TWO_SIDED|95.0|0.7|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||1.9|0.7|0.6076
71107638|NCT00565409|141721033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.8|||<|0.0001|TWO_SIDED|95.0|2.4|6.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||6.0|2.4|<0.0001
71107639|NCT00565409|141721033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.85|||<|0.0001|TWO_SIDED|95.0|1.8|4.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||4.6|1.8|<0.0001
71107640|NCT00565409|141721033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.7837|TWO_SIDED|95.0|0.6|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||1.6|0.6|0.7837
70933825|NCT02434328|141368956|OTHER||Difference in proportions|-1.7|||||TWO_SIDED|95.0|-8.4|5.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||5.0|-8.4|
71107641|NCT00565409|141721033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.0001|TWO_SIDED|95.0|2.0|4.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||4.7|2.0|<0.0001
71107642|NCT00565409|141721034|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4||||<0.0001
71107643|NCT00565409|141721034|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 8||||<0.0001
71107644|NCT00565409|141721034|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 12||||<0.0001
71107645|NCT00565409|141721034|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 20||||<0.0001
71107646|NCT00565409|141721034|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 28||||<0.0001
71107647|NCT00565409|141721034|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 36||||<0.0001
71107648|NCT00565409|141721035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.5263|TWO_SIDED|95.0|0.7|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||2.0|0.7|0.5263
71107649|NCT00565409|141721035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.1055|TWO_SIDED|95.0|0.9|2.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||2.3|0.9|0.1055
71107650|NCT00565409|141721035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.4348|TWO_SIDED|95.0|0.5|1.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||1.4|0.5|0.4348
71022760|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.33|||||TWO_SIDED|95.0|-18.72|12.06||||||For change in social functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||12.06|-18.72|
71056192|NCT00261443|141616383|SUPERIORITY_OR_OTHER_LEGACY|||||||0.105||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Creatinine||||0.105
70933826|NCT02434328|141368956|OTHER||Difference in proportions|-3.6|||||TWO_SIDED|95.0|-10.4|2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||2.9|-10.4|
70933827|NCT02434328|141368956|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-6.5|7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||7.2|-6.5|
70933828|NCT02434328|141368956|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-7.5|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.1|-7.5|
70933829|NCT02434328|141368956|OTHER||Difference in proportions|-3.5|||||TWO_SIDED|95.0|-10.4|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||3.1|-10.4|
71056193|NCT00261443|141616383|SUPERIORITY_OR_OTHER_LEGACY|||||||0.634||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Creatinine at Week 52 (LOCF)||||0.634
71056194|NCT00261443|141616383|SUPERIORITY_OR_OTHER_LEGACY|||||||0.958||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Creatinine During Phase 3||||0.958
71056195|NCT00261443|141616384|SUPERIORITY_OR_OTHER_LEGACY|||||||0.507||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Eosinophils (relative)||||0.507
71056196|NCT00261443|141616384|SUPERIORITY_OR_OTHER_LEGACY|||||||0.834||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Eosinophils (relative) at Week 52 (LOCF)||||0.834
70933830|NCT02434328|141368956|OTHER||Difference in proportions|-2.5|||||TWO_SIDED|95.0|-9.6|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.9|-9.6|
70933831|NCT02434328|141368956|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-5.0|8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||8.3|-5.0|
70941668|NCT04748445|141383934|OTHER||Slope|0.007542|STANDARD_ERROR_OF_MEAN|1.639||0.6461|TWO_SIDED|90.0|-0.01961|0.0347|||Mixed Models Analysis|||MM\_MFCC std 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.03470|-0.01961|0.6461
71022761|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.41|||||TWO_SIDED|95.0|-1.62|22.44||||||For change in fatigue at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||22.44|-1.62|
71022762|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3|||||TWO_SIDED|95.0|-16.55|7.96||||||For change in nausea and vomiting at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||7.96|-16.55|
71022763|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.37|||||TWO_SIDED|95.0|-7.57|22.32||||||For change in pain at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||22.32|-7.57|
71022764|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.51|||||TWO_SIDED|95.0|-1.28|26.3||||||For change in dyspnea at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||26.30|-1.28|
71022765|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.9|||||TWO_SIDED|95.0|-5.7|25.49||||||For change in insomnia at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||25.49|-5.70|
71022766|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.63|||||TWO_SIDED|95.0|-4.81|32.07||||||For change in appetite loss at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||32.07|-4.81|
71022767|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.67|||||TWO_SIDED|95.0|-11.62|20.96||||||For change in constipation at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||20.96|-11.62|
71022768|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28|||||TWO_SIDED|95.0|-15.1|12.54||||||For change in diarrhea at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||12.54|-15.1|
71022769|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.43|||||TWO_SIDED|95.0|-4.67|15.53||||||For change in financial difficulties at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||15.53|-4.67|
71022770|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.83|||||TWO_SIDED|95.0|-32.34|0.67||||||For change in global QoL at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||0.67|-32.34|
71022771|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.58|||||TWO_SIDED|95.0|-24.12|0.96||||||For change in physical functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||0.96|-24.12|
71022772|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.65|||||TWO_SIDED|95.0|-35.47|-1.83||||||For change in role functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||-1.83|-35.47|
70933832|NCT02434328|141368956|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-7.0|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||6.8|-7.0|
70933833|NCT02434328|141368957|OTHER||Difference in proportions|-3.5|||||TWO_SIDED|95.0|-10.4|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.6|-10.4|
70933834|NCT02434328|141368957|OTHER||Difference in proportions|-3.2|||||TWO_SIDED|95.0|-10.2|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||3.7|-10.2|
70933835|NCT02434328|141368957|OTHER||Difference in proportions|-3.7|||||TWO_SIDED|95.0|-10.7|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||3.3|-10.7|
70933836|NCT02434328|141368957|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-8.4|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||5.7|-8.4|
70933837|NCT02434328|141368957|OTHER||Difference in proportions|-5.3|||||TWO_SIDED|95.0|-12.3|1.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||1.5|-12.3|
70933838|NCT02434328|141368957|OTHER||Difference in proportions|-3.2|||||TWO_SIDED|95.0|-9.9|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||3.7|-9.9|
70933839|NCT02434328|141368957|OTHER||Difference in proportions|-5.9|||||TWO_SIDED|95.0|-12.8|0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||0.7|-12.8|
70933840|NCT02434328|141368957|OTHER||Difference in proportions|-1.9|||||TWO_SIDED|95.0|-8.2|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.8|-8.2|
70933841|NCT02434328|141368957|OTHER||Difference in proportions|-2.3|||||TWO_SIDED|95.0|-9.2|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||4.2|-9.2|
70933842|NCT02434328|141368957|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-8.2|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||5.6|-8.2|
70933843|NCT02434328|141368957|OTHER||Difference in proportions|-1.5|||||TWO_SIDED|95.0|-8.5|5.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||5.0|-8.5|
70851628|NCT00265148|141191059|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.07||||0.681|TWO_SIDED|95.0|-0.4|0.26|||Repeated measure mixed model|||Overall||0.26|-0.40|0.6810
71022773|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.92|||||TWO_SIDED|95.0|-29.16|1.32||||||For change in emotional functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||1.32|-29.16|
70851629|NCT00265148|141191063|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.2||||0.8593|TWO_SIDED|95.0|-2.38|1.99|||Repeated measure mixed model|||At Month 1||1.99|-2.38|0.8593
70933844|NCT02434328|141368957|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-7.4|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||6.2|-7.4|
70933845|NCT02434328|141368957|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-9.8|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.0|-9.8|
70933846|NCT02434328|141368957|OTHER||Difference in proportions|-1.7|||||TWO_SIDED|95.0|-8.6|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||4.8|-8.6|
71022774|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.1|||||TWO_SIDED|95.0|-20.97|6.77||||||For change in cognitive functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||6.77|-20.97|
71022775|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.62|||||TWO_SIDED|95.0|-28.28|9.04||||||For change in social functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||9.04|-28.28|
70933847|NCT02434328|141368957|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-7.8|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||6.1|-7.8|
70933848|NCT02434328|141368957|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-4.5|9.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||9.2|-4.5|
70933849|NCT02434328|141368957|OTHER||Difference in proportions|-1.5|||||TWO_SIDED|95.0|-8.6|4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||4.9|-8.6|
70933850|NCT02434328|141368957|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-5.8|7.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||7.5|-5.8|
70933851|NCT02434328|141368957|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-5.1|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||8.4|-5.1|
70933852|NCT02434328|141368957|OTHER||Difference in proportions|4.2|||||TWO_SIDED|95.0|-2.8|10.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||10.9|-2.8|
70933853|NCT02434328|141368957|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-9.3|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.1|-9.3|
70933854|NCT02434328|141368957|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-6.1|7.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||7.7|-6.1|
70933855|NCT02434328|141368957|OTHER||Difference in proportions|3.7|||||TWO_SIDED|95.0|-3.0|10.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||10.4|-3.0|
70933856|NCT02434328|141368957|OTHER||Difference in proportions|3.1|||||TWO_SIDED|95.0|-3.9|10.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||10.0|-3.9|
71107651|NCT00565409|141721035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.16||||0.0003|TWO_SIDED|95.0|1.4|3.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||3.3|1.4|0.0003
71107652|NCT00565409|141721035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.5511|TWO_SIDED|95.0|0.7|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||1.7|0.7|0.5511
70933857|NCT02434328|141368958|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.6|1.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||1.4|-1.6|
70933858|NCT02434328|141368958|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-2.3|1.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.1|-2.3|
70933859|NCT02434328|141368958|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.9|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2 mg) was estimated using a bootstrap method.|Week 12||2.2|-1.9|
70933860|NCT02434328|141368958|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-2.1|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||2.3|-2.1|
71107653|NCT00565409|141721035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92||||0.0013|TWO_SIDED|95.0|1.3|2.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||2.9|1.3|0.0013
71107654|NCT00565409|141721035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.79|||<|0.0001|TWO_SIDED|95.0|1.8|4.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||4.3|1.8|<0.0001
70933861|NCT02434328|141368958|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-2.0|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||3.3|-2.0|
70933862|NCT02434328|141368958|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-3.0|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||2.2|-3.0|
70933863|NCT02434328|141368958|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-3.0|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.3|-3.0|
71022776|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.14|||||TWO_SIDED|95.0|-1.27|33.54||||||For change in fatigue at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||33.54|-1.27|
71022777|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|||||TWO_SIDED|95.0|-18.78|15.18||||||For change in nausea and vomiting at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||15.18|-18.78|
71107655|NCT00565409|141721035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.9225|TWO_SIDED|95.0|0.6|1.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||1.5|0.6|0.9225
71107656|NCT00565409|141721035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.95|||<|0.0001|TWO_SIDED|95.0|1.9|4.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||4.5|1.9|<0.0001
71107657|NCT00565409|141721035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.2|||<|0.0001|TWO_SIDED|95.0|2.7|6.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||6.6|2.7|<0.0001
71107658|NCT00565409|141721035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.2454|TWO_SIDED|95.0|0.9|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||2.0|0.9|0.2454
71107659|NCT00565409|141721035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.15|||<|0.0001|TWO_SIDED|95.0|2.0|4.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||4.9|2.0|<0.0001
70851630|NCT00265148|141191063|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.44||||0.3201|TWO_SIDED|95.0|-1.43|4.32|||Repeated measure mixed model|||At Month 6||4.32|-1.43|0.3201
70851631|NCT00265148|141191063|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.18||||0.2627|TWO_SIDED|95.0|-1.68|6.04|||Repeated measure mixed model|||At Month 12||6.04|-1.68|0.2627
70933864|NCT02434328|141368958|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-3.2|2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||2.5|-3.2|
71022778|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.59|||||TWO_SIDED|95.0|-3.22|36.39||||||For change in pain at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||36.39|-3.22|
71022779|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.39|||||TWO_SIDED|95.0|-5.68|26.47||||||For change in dyspnea at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||26.47|-5.68|
71022780|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.59|||||TWO_SIDED|95.0|-20.19|23.36||||||For change in insomnia at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||23.36|-20.19|
71107660|NCT00565409|141721035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.83|||<|0.0001|TWO_SIDED|95.0|2.4|6.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||6.0|2.4|<0.0001
71107661|NCT00565409|141721035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.4919|TWO_SIDED|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||1.9|0.8|0.4919
71107662|NCT00565409|141721035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.16|||<|0.0001|TWO_SIDED|95.0|2.0|4.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||4.9|2.0|<0.0001
70933865|NCT02434328|141368958|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-2.3|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||3.3|-2.3|
70933866|NCT02434328|141368958|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-1.7|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||4.6|-1.7|
71022781|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.24|||||TWO_SIDED|95.0|-7.62|40.1||||||For change in appetite loss at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||40.1|-7.62|
71107663|NCT00565409|141721035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.8|||<|0.0001|TWO_SIDED|95.0|3.0|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||7.6|3.0|<0.0001
71107664|NCT00565409|141721035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.0658|TWO_SIDED|95.0|1.0|2.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||2.3|1.0|0.0658
71022782|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.76|||||TWO_SIDED|95.0|-17.49|23.02||||||For change in constipation at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||23.02|-17.49|
71022783|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.87|||||TWO_SIDED|95.0|-16.29|22.03||||||For change in diarrhea at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||22.03|-16.29|
71022784|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.56|||||TWO_SIDED|95.0|-9.81|20.92||||||For change in financial difficulties at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||20.92|-9.81|
71022785|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.97|||||TWO_SIDED|95.0|-19.52|7.57||||||For change in global QoL at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||7.57|-19.52|
71022786|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.64|||||TWO_SIDED|95.0|-19.75|8.46||||||For change in physical functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||8.46|-19.75|
71022787|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.53|||||TWO_SIDED|95.0|-39.11|4.05||||||For change in role functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||4.05|-39.11|
71022788|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.25|||||TWO_SIDED|95.0|-26.5|2.0||||||For change in emotional functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||2.00|-26.5|
71107665|NCT00565409|141721035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.0001|TWO_SIDED|95.0|2.0|4.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||4.7|2.0|<0.0001
71022789|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.99|||||TWO_SIDED|95.0|-23.13|9.15||||||For change in cognitive functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||9.15|-23.13|
71022790|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.09|||||TWO_SIDED|95.0|-30.48|16.31||||||For change in social functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||16.31|-30.48|
71022791|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.88|||||TWO_SIDED|95.0|-5.86|27.63||||||For change in fatigue at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||27.63|-5.86|
71022792|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.1|||||TWO_SIDED|95.0|-24.11|1.91||||||For change in nausea and vomiting at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||1.91|-24.11|
71022793|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.13|||||TWO_SIDED|95.0|-24.26|14.0||||||For change in pain at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||14.00|-24.26|
71022794|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.13|||||TWO_SIDED|95.0|-14.18|24.44||||||For change in dyspnea at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||24.44|-14.18|
71022795|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.33|||||TWO_SIDED|95.0|-26.25|13.59||||||For change in insomnia at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||13.59|-26.25|
71022796|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.03|||||TWO_SIDED|95.0|-15.26|33.32||||||For change in appetite loss at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||33.32|-15.26|
71022797|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|||||TWO_SIDED|95.0|-25.71|26.82||||||For change in constipation at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||26.82|-25.71|
71022798|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.97|||||TWO_SIDED|95.0|-24.07|28.01||||||For change in diarrhea at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||28.01|-24.07|
71022799|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.48|||||TWO_SIDED|95.0|-5.89|24.86||||||For change in financial difficulties at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||24.86|-5.89|
71022800|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.01|||||TWO_SIDED|95.0|-43.19|3.17||||||For change in global QoL at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||3.17|-43.19|
71022801|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.57|||||TWO_SIDED|95.0|-27.24|10.1||||||For change in physical functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||10.10|-27.24|
71107666|NCT00565409|141721035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.32|||<|0.0001|TWO_SIDED|95.0|2.7|6.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||6.8|2.7|<0.0001
70933867|NCT02434328|141368958|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-2.7|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||3.4|-2.7|
70933868|NCT02434328|141368958|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-3.9|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||2.2|-3.9|
70933869|NCT02434328|141368958|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-4.3|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||2.3|-4.3|
70933870|NCT02434328|141368958|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-2.8|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||3.9|-2.8|
70933871|NCT02434328|141368958|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-2.5|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||4.2|-2.5|
70933872|NCT02434328|141368958|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-2.7|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||4.5|-2.7|
70933873|NCT02434328|141368958|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-4.2|2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||2.6|-4.2|
70933874|NCT02434328|141368958|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-2.5|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||4.5|-2.5|
70933875|NCT02434328|141368958|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-2.5|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.4|-2.5|
71107667|NCT00565409|141721035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.4014|TWO_SIDED|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||1.9|0.8|0.4014
71107668|NCT00565409|141721035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.54|||<|0.0001|TWO_SIDED|95.0|2.3|5.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||5.5|2.3|<0.0001
70933876|NCT02434328|141368958|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-2.4|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||4.6|-2.4|
70933877|NCT02434328|141368958|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-3.1|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.1|-3.1|
70933878|NCT02434328|141368958|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-3.5|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.6|-3.5|
71107669|NCT00565409|141721035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.53|||<|0.0001|TWO_SIDED|95.0|2.9|7.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||7.2|2.9|<0.0001
71107670|NCT00565409|141721035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.2824|TWO_SIDED|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||1.9|0.8|0.2824
70933879|NCT02434328|141368958|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-3.8|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||3.3|-3.8|
70933880|NCT02434328|141368958|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-3.8|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||3.3|-3.8|
71107671|NCT00565409|141721035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.83|||<|0.0001|TWO_SIDED|95.0|2.5|5.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||5.9|2.5|<0.0001
71107672|NCT00565409|141721036|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4||||<0.0001
70933881|NCT02434328|141368959|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-2.6|1.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||1.6|-2.6|
70933882|NCT02434328|141368959|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-2.2|2.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||2.1|-2.2|
70933883|NCT02434328|141368959|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-2.8|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.2|-2.8|
71022802|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.07|||||TWO_SIDED|95.0|-41.1|8.96||||||For change in role functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||8.96|-41.10|
71056197|NCT00261443|141616384|SUPERIORITY_OR_OTHER_LEGACY|||||||0.511||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Eosinophils (relative) During Phase 3||||0.511
71056198|NCT00261443|141616385|SUPERIORITY_OR_OTHER_LEGACY|||||||0.741||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Glucose (fasting)||||0.741
71056199|NCT00261443|141616385|SUPERIORITY_OR_OTHER_LEGACY|||||||0.962||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Glucose (fasting) at Week 52 (LOCF)||||0.962
71056200|NCT00261443|141616385|SUPERIORITY_OR_OTHER_LEGACY|||||||0.592||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Change Value in Glucose (fasting) During Phase 3||||0.592
71056201|NCT00261443|141616386|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Hemoglobin||||0.080
71056202|NCT00261443|141616386|SUPERIORITY_OR_OTHER_LEGACY|||||||0.868||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Hemoglobin at Week 52 (LOCF)||||0.868
71056203|NCT00261443|141616386|SUPERIORITY_OR_OTHER_LEGACY|||||||0.299||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Change Value in Hemoglobin During Phase 3||||0.299
71056204|NCT00261443|141616387|SUPERIORITY_OR_OTHER_LEGACY|||||||0.187||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Hematocrit||||0.187
71056205|NCT00261443|141616387|SUPERIORITY_OR_OTHER_LEGACY|||||||0.377||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Hematocrit During Week 52 (LOCF)||||0.377
71107673|NCT00565409|141721036|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8||||<0.0001
71022803|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.11|||||TWO_SIDED|95.0|-42.72|-5.5||||||For change in emotional functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||-5.50|-42.72|
71022804|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.52|||||TWO_SIDED|95.0|-29.66|10.61||||||For change in cognitive functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||10.61|-29.66|
71022805|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.24|||||TWO_SIDED|95.0|-47.93|7.46||||||For change in social functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||7.46|-47.93|
71056206|NCT00261443|141616387|SUPERIORITY_OR_OTHER_LEGACY|||||||0.494||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Value of Change in Hematocrit During Phase 3||||0.494
71056207|NCT00261443|141616388|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline HDL Cholesterol (fasting)||||0.180
71056208|NCT00261443|141616388|SUPERIORITY_OR_OTHER_LEGACY|||||||0.95||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in HDL Cholesterol (fasting) at Week 52 (LOCF)||||0.950
71056209|NCT00261443|141616388|SUPERIORITY_OR_OTHER_LEGACY|||||||0.342||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Value of Change in HDL Cholesterol (fasting) During Phase 3||||0.342
71056210|NCT00261443|141616389|SUPERIORITY_OR_OTHER_LEGACY|||||||0.349||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline HOMA2-Percent Beta||||0.349
71056211|NCT00261443|141616389|SUPERIORITY_OR_OTHER_LEGACY|||||||0.624||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in HOMA2-Percent Beta at Week 52 (LOCF)||||0.624
71056212|NCT00261443|141616389|SUPERIORITY_OR_OTHER_LEGACY|||||||0.329||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value in HOMA2-Percent Beta During Phase 3||||0.329
71056213|NCT00261443|141616390|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline HOMA2-IR||||0.550
71056214|NCT00261443|141616390|SUPERIORITY_OR_OTHER_LEGACY|||||||0.554||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in HOMA2-IR at Week 52 (LOCF)||||0.554
71056215|NCT00261443|141616390|SUPERIORITY_OR_OTHER_LEGACY|||||||0.87||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in HOMA2-IR, Phase 3 Safety Sample||||0.870
71056216|NCT00261443|141616391|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Lactate Dehydrogenase||||0.004
71107674|NCT00565409|141721036|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||<0.0001
71107675|NCT00565409|141721036|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20||||<0.0001
71107676|NCT00565409|141721036|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||<0.0001
71107677|NCT00565409|141721036|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||week 36||||<0.0001
71107678|NCT00565409|141721037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.0575|TWO_SIDED|95.0|1.0|2.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||2.3|1.0|0.0575
71107679|NCT00565409|141721037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.063|TWO_SIDED|95.0|1.0|2.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||2.3|1.0|0.0630
71107680|NCT00565409|141721037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.916|TWO_SIDED|95.0|0.7|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||1.6|0.7|0.9160
71107681|NCT00565409|141721037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.76||||0.0147|TWO_SIDED|95.0|1.0|3.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||3.0|1.0|0.0147
71107682|NCT00565409|141721037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.8675|TWO_SIDED|95.0|0.6|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||1.6|0.6|0.8675
71107683|NCT00565409|141721037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77||||0.0174|TWO_SIDED|95.0|1.1|3.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||3.0|1.1|0.0174
70933884|NCT02434328|141368959|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-4.4|1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||1.7|-4.4|
70933885|NCT02434328|141368959|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-1.7|4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||4.9|-1.7|
71107684|NCT00565409|141721037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.24|||<|0.0001|TWO_SIDED|95.0|1.9|5.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||5.7|1.9|<0.0001
71107685|NCT00565409|141721037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.4941|TWO_SIDED|95.0|0.5|1.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||1.3|0.5|0.4941
71107686|NCT00565409|141721037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.01|||<|0.0001|TWO_SIDED|95.0|2.3|7.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||7.0|2.3|<0.0001
71107687|NCT00565409|141721037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.4|||<|0.0001|TWO_SIDED|95.0|2.0|5.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||5.9|2.0|<0.0001
71107688|NCT00565409|141721037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.8185|TWO_SIDED|95.0|0.6|1.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||1.5|0.6|0.8185
71107689|NCT00565409|141721037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.66|||<|0.0001|TWO_SIDED|95.0|2.1|6.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||6.4|2.1|<0.0001
71107690|NCT00565409|141721037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.78|||<|0.0001|TWO_SIDED|95.0|2.2|6.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||6.6|2.2|<0.0001
71107691|NCT00565409|141721037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.4254|TWO_SIDED|95.0|0.7|1.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||1.8|0.7|0.4254
70851632|NCT00265148|141191063|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.14||||0.3633|TWO_SIDED|95.0|-1.35|3.64|||Repeated measure mixed model|||For overall period||3.64|-1.35|0.3633
71107692|NCT00565409|141721037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.38|||<|0.0001|TWO_SIDED|95.0|1.9|5.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||5.9|1.9|<0.0001
71107693|NCT00565409|141721037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.26|||<|0.0001|TWO_SIDED|95.0|1.8|5.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||5.8|1.8|<0.0001
71107694|NCT00565409|141721037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.8766|TWO_SIDED|95.0|0.7|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||1.6|0.7|0.8766
71107695|NCT00565409|141721037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.67|||<|0.0001|TWO_SIDED|95.0|2.1|6.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||6.4|2.1|<0.0001
71107696|NCT00565409|141721037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.53|||<|0.0001|TWO_SIDED|95.0|2.0|6.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||6.4|2.0|<0.0001
71107697|NCT00565409|141721037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.3535|TWO_SIDED|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||1.9|0.8|0.3535
70933886|NCT02434328|141368959|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-3.9|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||2.8|-3.9|
70933887|NCT02434328|141368959|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-3.2|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||3.8|-3.2|
71056217|NCT00261443|141616391|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Lactate Dehydrogenase||||0.034
71056218|NCT00261443|141616391|SUPERIORITY_OR_OTHER_LEGACY|||||||0.091||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Lactate Dehydrogenase During Phase 3||||0.091
71056219|NCT00261443|141616392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.808||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline LDL Cholesterol (fasting)||||0.808
71056220|NCT00261443|141616392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.507||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)||||0.507
71056221|NCT00261443|141616392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.948||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Change Value in LDL Cholesterol (fasting)||||0.948
71107698|NCT00565409|141721037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.44|||<|0.0001|TWO_SIDED|95.0|1.9|6.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||6.1|1.9|<0.0001
71107699|NCT00565409|141721037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.45|||<|0.0001|TWO_SIDED|95.0|2.0|6.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||6.1|2.0|<0.0001
71107700|NCT00565409|141721037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.3231|TWO_SIDED|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||1.9|0.8|0.3231
71107701|NCT00565409|141721037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.23|||<|0.0001|TWO_SIDED|95.0|1.9|5.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||5.6|1.9|<0.0001
71107702|NCT00565409|141721038|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4||||<0.0001
70933888|NCT02434328|141368959|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-3.8|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||3.5|-3.8|
70933889|NCT02434328|141368959|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-3.0|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||4.2|-3.0|
70933890|NCT02434328|141368959|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.4|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||5.1|-2.4|
71056222|NCT00261443|141616393|SUPERIORITY_OR_OTHER_LEGACY|||||||0.967||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Neutrophils (relative)||||0.967
71056223|NCT00261443|141616393|SUPERIORITY_OR_OTHER_LEGACY|||||||0.486||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison in change from Baseline in Neutrophils (relative) at Week 52 (LOCF)||||0.486
71056224|NCT00261443|141616393|SUPERIORITY_OR_OTHER_LEGACY|||||||0.323||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Neutrophils (relative), Phase 3 Safety Sample||||0.323
71056225|NCT00261443|141616394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.663||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline in Platelet Count||||0.663
71056226|NCT00261443|141616394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.322||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)||||0.322
71056227|NCT00261443|141616394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.358||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Platelet Count, Phase 3 Safety Sample||||0.358
71056228|NCT00261443|141616394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.541||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Value of Change in Platelet Count, Phase 3 Safety Sample||||0.541
71056229|NCT00261443|141616395|SUPERIORITY_OR_OTHER_LEGACY|||||||0.412||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Prolactin||||0.412
71107703|NCT00565409|141721038|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8||||<0.0001
71107704|NCT00565409|141721038|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||<0.0001
71107705|NCT00565409|141721038|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 20||||<0.0001
71107706|NCT00565409|141721038|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||<0.0001
70851633|NCT00265148|141191064|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.11||||0.5647|TWO_SIDED|95.0|-0.48|0.26|||Repetaed measure mixed model|||For overall period||0.26|-0.48|0.5647
71107707|NCT00565409|141721038|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 36||||<0.0001
71022806|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.0|||||TWO_SIDED|95.0|3.23|46.77||||||For change in fatigue at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||46.77|3.23|
71022807|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.25|||||TWO_SIDED|95.0|-13.49|25.99||||||For change in nausea and vomiting at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||25.99|-13.49|
71022808|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.64|||||TWO_SIDED|95.0|-7.12|46.41||||||For change in pain at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||46.41|-7.12|
71107708|NCT00565409|141721039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.14||||0.0089|TWO_SIDED|95.0|0.9|5.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||5.2|0.9|0.0089
71022809|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.02|||||TWO_SIDED|95.0|0.38|43.66||||||For change in dyspnea at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||43.66|0.38|
71022810|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.12|||||TWO_SIDED|95.0|-18.49|38.73||||||For change in insomnia at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||38.73|-18.49|
71022811|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.83|||||TWO_SIDED|95.0|-13.98|55.65||||||For change in appetite loss at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||55.65|-13.98|
71022812|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.9|||||TWO_SIDED|95.0|-19.02|42.83||||||For change in constipation at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||42.83|-19.02|
71022813|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.9|||||TWO_SIDED|95.0|-16.13|39.94||||||For change in diarrhea at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||39.94|-16.13|
71022814|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-23.38|23.38||||||For change in financial difficulties at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||23.38|-23.38|
71022815|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.66|||||TWO_SIDED|95.0|-34.53|17.21||||||For change in global QoL at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups||17.21|-34.53|
71022816|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.98|||||TWO_SIDED|95.0|-52.01|26.04||||||For change in physical functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||26.04|-52.01|
71107709|NCT00565409|141721039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.6932|TWO_SIDED|95.0|0.5|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||1.7|0.5|0.6932
71022817|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.32|||||TWO_SIDED|95.0|-71.87|19.24||||||For change in role functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||19.24|-71.87|
71022818|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.14|||||TWO_SIDED|95.0|-26.59|14.31||||||For change in emotional functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||14.31|-26.59|
71022819|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.99|||||TWO_SIDED|95.0|-35.46|11.48||||||For change in cognitive functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||11.48|-35.46|
71022820|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.04|||||TWO_SIDED|95.0|-20.97|49.04||||||For change in social functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||49.04|-20.97|
71022821|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.39|||||TWO_SIDED|95.0|-15.83|62.61||||||For change in fatigue at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||62.61|-15.83|
71022822|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.95|||||TWO_SIDED|95.0|-30.84|38.73||||||For change in nausea and vomiting at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||38.73|-30.84|
71022823|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.56|||||TWO_SIDED|95.0|-13.08|62.2||||||For change in pain at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||62.20|-13.08|
71022824|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.85|||||TWO_SIDED|95.0|-38.65|34.94||||||For change in dyspnea at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||34.94|-38.65|
71022825|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.65|||||TWO_SIDED|95.0|-37.43|56.73||||||For change in insomnia at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||56.73|-37.43|
71022826|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.16|||||TWO_SIDED|95.0|-71.22|97.54||||||For change in appetite loss at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||97.54|-71.22|
71022827|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.81|||||TWO_SIDED|95.0|-22.61|68.22||||||For change in constipation at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||68.22|-22.61|
71022828|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75|||||TWO_SIDED|95.0|-39.1|35.59||||||For change in diarrhea at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||35.59|-39.10|
71022829|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.98|||||TWO_SIDED|95.0|1.09|46.86||||||For change in financial difficulties at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||46.86|1.09|
71022830|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.04|||||TWO_SIDED|95.0|-39.03|63.11||||||For change in global QoL at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||63.11|-39.03|
71022831|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.89|||||TWO_SIDED|95.0|-20.74|58.52||||||For change in physical functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||58.52|-20.74|
71107710|NCT00565409|141721039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.76||||0.0019|TWO_SIDED|95.0|1.2|6.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||6.1|1.2|0.0019
71056230|NCT00261443|141616395|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline at Week 52 (LOCF)||||<0.001
71056231|NCT00261443|141616395|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Prolactin, Phase 3 Safety Sample||||0.004
71056232|NCT00261443|141616396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Total Bilirubin||||0.630
71056233|NCT00261443|141616396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.675||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)||||0.675
71056234|NCT00261443|141616396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.592||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Total Bilirubin, Phase 3 Safety Sample||||0.592
71056235|NCT00261443|141616397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.273||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Triglycerides (fasting)||||0.273
71056236|NCT00261443|141616397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.489||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)||||0.489
71056237|NCT00261443|141616397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.415||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Triglycerides (fasting), Phase 3 Safety Sample||||0.415
71056238|NCT00261443|141616398|SUPERIORITY_OR_OTHER_LEGACY|||||||0.189||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Uric Acid||||0.189
71056239|NCT00261443|141616398|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)||||0.350
71056240|NCT00261443|141616398|SUPERIORITY_OR_OTHER_LEGACY|||||||0.799||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Uric Acid, Phase 3 Safety Sample||||0.799
71056241|NCT00261443|141616399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.124||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Leukocytes||||0.124
71056242|NCT00261443|141616399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.295||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)||||0.295
71056243|NCT00261443|141616399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.735||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Highest Value of Change in Leukocytes, Phase 3||||0.735
70851634|NCT00265148|141191064|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.9935|TWO_SIDED|95.0|-0.46|0.46|||Repeated measure mixed model|||For Month 1||0.46|-0.46|0.9935
71056244|NCT00261443|141616399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.505||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Lowest Value of Change in Leukocytes, Phase 3||||0.505
71056245|NCT00261443|141616401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.213||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline QTc Bazett||||0.213
71056246|NCT00261443|141616401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.708||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in QTc Bazett at Week 52 (LOCF)||||0.708
70851635|NCT00265148|141191064|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.22||||0.3794|TWO_SIDED|95.0|-0.72|0.28|||Repeated measure mixed model|||At Month 6||0.28|-0.72|0.3794
70851636|NCT00265148|141191064|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.7357|TWO_SIDED|95.0|-0.7|0.49|||Repeated measure mixed model|||At Month 12||0.49|-0.70|0.7357
71056247|NCT00261443|141616401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.107||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in QTc Bazett, Phase 3||||0.107
71056248|NCT00261443|141616402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.205||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline QTc (0.33)||||0.205
71056249|NCT00261443|141616402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.669||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in QTc (0.33) at Week 52 (LOCF)||||0.669
71056250|NCT00261443|141616402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.072||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in QTc (0.33), Phase 3||||0.072
71056251|NCT00261443|141616403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline PR||||0.012
71056252|NCT00261443|141616403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in PR at Week 52 (LOCF)||||0.027
71056253|NCT00261443|141616403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.128||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in PR, Phase 3||||0.128
71056254|NCT00261443|141616404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.571||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline RR||||0.571
71056255|NCT00261443|141616404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.353||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in RR at Week 52 (LOCF)||||0.353
71056256|NCT00261443|141616404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.204||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in RR, Phase 3 Safety Sample||||0.204
71056257|NCT00261443|141616404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.435||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Value of Change in Prolactin, Phase 3 Safety Sample||||0.435
71056258|NCT00261443|141616405|SUPERIORITY_OR_OTHER_LEGACY|||||||0.826||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline QRS||||0.826
71056259|NCT00261443|141616405|SUPERIORITY_OR_OTHER_LEGACY|||||||0.545||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in QRS at Week 52 (LOCF)||||0.545
71107711|NCT00565409|141721039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.0797|TWO_SIDED|95.0|0.6|3.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||3.6|0.6|0.0797
71107712|NCT00565409|141721039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.8103|TWO_SIDED|95.0|0.4|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||1.9|0.4|0.8103
71107713|NCT00565409|141721039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87||||0.0903|TWO_SIDED|95.0|0.8|4.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||4.5|0.8|0.0903
71107714|NCT00565409|141721039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.02||||0.0035|TWO_SIDED|95.0|1.2|7.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||7.8|1.2|0.0035
71107715|NCT00565409|141721039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.977|TWO_SIDED|95.0|0.5|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||2.0|0.5|0.9770
71107716|NCT00565409|141721039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.29||||0.0036|TWO_SIDED|95.0|1.3|8.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||8.3|1.3|0.0036
71107717|NCT00565409|141721039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.8||||0.0038|TWO_SIDED|95.0|1.0|7.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||7.7|1.0|0.0038
71107718|NCT00565409|141721039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9055|TWO_SIDED|95.0|0.5|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||2.0|0.5|0.9055
71107719|NCT00565409|141721039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.36||||0.002|TWO_SIDED|95.0|1.2|9.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||9.8|1.2|0.0020
71107720|NCT00565409|141721039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.35||||0.002|TWO_SIDED|95.0|1.3|8.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||8.8|1.3|0.0020
71107721|NCT00565409|141721039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.5763|TWO_SIDED|95.0|0.4|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||1.7|0.4|0.5763
71107722|NCT00565409|141721039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.93||||0.0002|TWO_SIDED|95.0|1.5|10.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||10.0|1.5|0.0002
71107723|NCT00565409|141721039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.21||||0.0004|TWO_SIDED|95.0|1.2|8.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||8.8|1.2|0.0004
71107724|NCT00565409|141721039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.4828|TWO_SIDED|95.0|0.4|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||1.6|0.4|0.4828
71107725|NCT00565409|141721039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.52|||<|0.0001|TWO_SIDED|95.0|1.4|9.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||9.0|1.4|<0.0001
71107726|NCT00565409|141721039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.28||||0.0002|TWO_SIDED|95.0|1.4|7.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||7.8|1.4|0.0002
71107727|NCT00565409|141721039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.8553|TWO_SIDED|95.0|0.6|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||1.9|0.6|0.8553
71107728|NCT00565409|141721039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.56||||0.0003|TWO_SIDED|95.0|1.5|8.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||8.7|1.5|0.0003
71022832|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-48.33|||||TWO_SIDED|95.0|-111.94|15.28||||||For change in role functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||15.28|-111.94|
71107729|NCT00565409|141721039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.53|||<|0.0001|TWO_SIDED|95.0|1.6|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||7.6|1.6|<0.0001
71107730|NCT00565409|141721039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.5025|TWO_SIDED|95.0|0.6|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||2.0|0.6|0.5025
71107731|NCT00565409|141721039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.62||||0.0001|TWO_SIDED|95.0|1.6|8.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||8.1|1.6|0.0001
71107732|NCT01918189|141721102|OTHER|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the primary measure of pain interference (i.e., WHYMPI-Interference Scale) at 10 weeks post-baseline.||||||0.008||||||a priori threshold for statistical significance is p \<0.05|Regression, Logistic|||||||0.008
70933891|NCT02434328|141368959|OTHER||Difference in proportions|2.5|||||TWO_SIDED|95.0|-1.1|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||6.5|-1.1|
70933892|NCT02434328|141368959|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-4.0|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||3.3|-4.0|
71022833|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|||||TWO_SIDED|95.0|-22.59|20.74||||||For change in emotional functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||20.74|-22.59|
71022834|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.22|||||TWO_SIDED|95.0|-24.98|39.43||||||For change in cognitive functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||39.43|-24.98|
71022835|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|||||TWO_SIDED|95.0|-57.71|77.71||||||For change in social functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||77.71|-57.71|
71022836|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.04|||||TWO_SIDED|95.0|-58.87|24.79||||||For change in fatigue at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||24.79|-58.87|
71022837|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.0|||||TWO_SIDED|95.0|-43.1|13.1||||||For change in nausea and vomiting at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||13.10|-43.10|
71022838|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.78|||||TWO_SIDED|95.0|-41.75|57.3||||||For change in pain at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||57.30|-41.75|
71022839|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.67|||||TWO_SIDED|95.0|-53.79|20.46||||||For change in dyspnea at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||20.46|-53.79|
71022840|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.11|||||TWO_SIDED|95.0|-73.14|30.92||||||For change in insomnia at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||30.92|-73.14|
71022841|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.22|||||TWO_SIDED|95.0|-115.58|51.13||||||For change in appetite loss at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||51.13|-115.58|
71022842|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.33|||||TWO_SIDED|95.0|-18.6|125.26||||||For change in constipation at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||125.26|-18.60|
70851637|NCT00265148|141191067|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4971.6||||0.6299|TWO_SIDED|95.0|-255515.6|15572.4|||Repeated measure mixed model|Arithmetic means have been presented; however, statistical analysis is based upon the least square (LS) means||At Month 6||15572.4|-255515.6|0.6299
71022843|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.33|||||TWO_SIDED|95.0|-34.92|41.58||||||For change in diarrhea at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||41.58|-34.92|
71022844|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.67|||||TWO_SIDED|95.0|-34.3|20.96||||||For change in financial difficulties at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||20.96|-34.3|
71022845|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.83|||||TWO_SIDED|95.0|-58.94|100.6||||||For change in global QoL at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||100.60|-58.94|
71022846|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.33|||||TWO_SIDED|95.0|-44.54|63.2||||||For change in physical functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||63.20|-44.54|
71022847|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.0|||||TWO_SIDED|95.0|-35.3|75.3||||||For change in role functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||75.30|-35.30|
71022848|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5|||||TWO_SIDED|95.0|-51.66|36.66||||||For change in emotional functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||36.66|-51.66|
71022849|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.67|||||TWO_SIDED|95.0|-36.06|69.39||||||For change in cognitive functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||69.39|-36.06|
70851638|NCT00265148|141191067|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|12223.0||||0.2184|TWO_SIDED|95.0|-7450.6|31896.5|||Repeated measure mixed model|||At Month 12||31896.5|-7450.6|0.2184
70851639|NCT00265148|141191068|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.6||||0.0129|TWO_SIDED|95.0|-1.0|-0.1|||Repeated measure mixed model|||For Month 6||-0.1|-1.0|0.0129
71022850|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|||||TWO_SIDED|95.0|-76.36|86.36||||||For change in social functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||86.36|-76.36|
71022851|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.78|||||TWO_SIDED|95.0|-77.63|42.08||||||For change in fatigue at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||42.08|-77.63|
71022852|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.67|||||TWO_SIDED|95.0|-62.33|28.99||||||For change in nausea and vomiting at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||28.99|-62.33|
71022853|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.33|||||TWO_SIDED|95.0|-79.59|96.26||||||For change in pain at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||96.26|-79.59|
71022854|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.52|||||TWO_SIDED|95.0|-89.98|52.94||||||For change in dyspnea at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||52.94|-89.98|
71022855|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.0|||||TWO_SIDED|95.0|-133.08|93.08||||||For change in insomnia at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||93.08|-133.08|
71107733|NCT01918189|141721103|OTHER|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the primary measure of pain intensity at 10 weeks post-baseline.|Mean Difference (Final Values)|0.05||||0.27|TWO_SIDED|95.0||||a priori threshold for statistical significance is p\<0.05|Regression, Logistic|||||||0.27
71107734|NCT01918189|141721104|OTHER|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the measure of mood symptoms at 10 weeks post-baseline.|Mean Difference (Net)|0.05||||0.02|TWO_SIDED|95.0||||a priori threshold for statistical significance is p\<0.05|Regression, Logistic|||||||0.02
71107735|NCT01918189|141721105|OTHER|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the measure of mood symptoms at 10 weeks post-baseline.|Mean Difference (Net)|0.05||||0.48|TWO_SIDED|||||a priori threshold for statistical significance is p\<0.05|Regression, Logistic|||||||0.48
71107736|NCT01918189|141721106|OTHER|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the measure of sleep at 10 weeks post-baseline.|Mean Difference (Net)|0.05||||0.18|TWO_SIDED|95.0||||a priori threshold for statistical significance is p\<0.05|Regression, Logistic|||||||0.18
71107737|NCT01918189|141721107|OTHER|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the measure of depression symptoms at 10 weeks post-baseline.|Mean Difference (Final Values)|0.05||||0.03|TWO_SIDED|95.0||||a priori threshold for statistical significance is p\<0.05|Regression, Logistic|||||||0.03
71107738|NCT01657305|141721108|SUPERIORITY_OR_OTHER||||||<|0.0001||||||2-sided, significance level = 0.05|t-test, 2 sided|||"All participants received both treatments and treatments were intra-individually compared.~Hypotheses tested: H0: δ = 0 and H1: δ ≠ 0 with δ being the difference in time to wound closure between treatments.~Negative values for the intra-individual time difference indicate faster healing of the Oleogel-S10-treated wound half.~For right-censored observations (no wound closure observed in blinded photo evaluation), wound closure was conservatively calculated as +1 day after the last photo."||||<0.0001
71107739|NCT01657305|141721112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_DEVIATION|13.4|<|0.0001|TWO_SIDED|95.0|6.0|11.2||Day 7|t-test, 2 sided||Difference in degree of epithelialization \[%\] (Oleogel-S10 minus standard of care)|||11.2|6.0|<0.0001
71107740|NCT01657305|141721112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.1|STANDARD_DEVIATION|17.0|<|0.0001|TWO_SIDED|95.0|6.9|13.4||Day 10|t-test, 2 sided||Difference in degree of epithelialization \[%\] (Oleogel-S10 minus standard of care)|||13.4|6.9|<0.0001
71107741|NCT01657305|141721112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9|STANDARD_DEVIATION|17.0|<|0.0001|TWO_SIDED|95.0|4.6|11.1||Day 14|t-test, 2 sided||Difference in degree of epithelialization \[%\] (Oleogel-S10 minus standard of care)|||11.1|4.6|<0.0001
70851640|NCT00265148|141191068|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.2||||0.5607|TWO_SIDED|95.0|-1.0|0.6|||Repeated measure mixed model|||For Month 12||0.6|-1.0|0.5607
71107742|NCT01657305|141721112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.4|STANDARD_DEVIATION|18.3|<|0.0001|TWO_SIDED|95.0|3.9|10.9||Day 18|t-test, 2 sided||Difference in degree of epithelialization \[%\] (Oleogel-S10 minus standard of care)|||10.9|3.9|<0.0001
71107743|NCT01657305|141721112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4|STANDARD_DEVIATION|14.1|<|0.0001|TWO_SIDED|95.0|3.7|9.1||Day 21|t-test, 2 sided||Difference in degree of epithelialization \[%\] (Oleogel-S10 minus standard of care)|||9.1|3.7|<0.0001
71107744|NCT01657305|141721112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|STANDARD_DEVIATION|12.9|=|0.0021|TWO_SIDED|95.0|1.5|6.4||Day 28|t-test, 2 sided||Difference in degree of epithelialization \[%\] (Oleogel-S10 minus standard of care)|||6.4|1.5|=0.0021
71107745|NCT01180127|141721143|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Repeated measures ANOVA|||Repeated measures ANOVA for the interaction of time (baseline vs 12 week) and flavanol group.||||.0001
71107746|NCT01180127|141721144|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED|||||The ANCOVA model included a main effect for both flavanol and exercise, so this p-value is for the effect of flavanol on Modbent controlling for baseline Modbent and exercise|ANCOVA|||ANCOVA used to test main effect of flavanol||||0.038
71107747|NCT01180127|141721144|SUPERIORITY_OR_OTHER|||||||0.815|TWO_SIDED|||||The ANCOVA included both a main effect for flavanol and exercise, so this p-value is for the test of exercise controlling for baseline Modbent and flavanol|ANCOVA|||ANCOVA used to test main effect of exercise||||0.815
71107748|NCT01180127|141721145|SUPERIORITY_OR_OTHER|||||||0.853|TWO_SIDED||||||ANCOVA|||ANCOVA for testing main effect of flavanol||||0.853
71107749|NCT01180127|141721145|SUPERIORITY_OR_OTHER|||||||0.581|TWO_SIDED||||||ANCOVA|||ANCOVA for testing main effect of exercise||||0.581
70851641|NCT00265148|141191080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1154||||0.28|TWO_SIDED|95.0|-0.0967|0.3275|||Repeated measure mixed model|||For Grey matter, APOE Epsilon-4 status positive||0.3275|-0.0967|0.2800
71107750|NCT01180127|141721146|SUPERIORITY_OR_OTHER|||||||0.237|TWO_SIDED||||||ANCOVA|||ANCOVA was used to test for an exercise effect.||||0.237
71117624|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
71107751|NCT00518180|141721153|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given concomitantly with HPV and Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup I minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-2.0|||||TWO_SIDED|95.0|-6.0|3.0||||||Immune response to Men A when MenACWY is administered concomitantly with Tdap and HPV, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||3|-6|
71107752|NCT00518180|141721153|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given concomitantly with HPV and Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup I minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-1.0|||||TWO_SIDED|95.0|-6.0|3.0||||||Immune response to Men C when MenACWY is administered concomitantly with Tdap and HPV, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||3|-6|
71107753|NCT00518180|141721153|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given concomitantly with HPV and Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup I minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-4.0|||||TWO_SIDED|95.0|-9.0|1.0||||||Immune response to Men W when MenACWY is administered concomitantly with Tdap and HPV, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||1|-9|
71107754|NCT00518180|141721153|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given concomitantly with HPV and Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup I minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|0.0|||||TWO_SIDED|95.0|-4.0|5.0||||||Immune response to Men Y when MenACWY is administered concomitantly with Tdap and HPV, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||5|-4|
70933893|NCT02434328|141368959|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-2.8|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.7|-2.8|
71056260|NCT00261443|141616405|SUPERIORITY_OR_OTHER_LEGACY|||||||0.372||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in QRS, Phase 3||||0.372
71056261|NCT00261443|141616406|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.235|TWO_SIDED|95.0|-0.07|0.27||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference||0.27|-0.07|0.235
71056262|NCT00261443|141616406|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36||||0.012|TWO_SIDED|95.0|0.08|0.64||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value in Change Treatment Difference||0.64|0.08|0.012
71056263|NCT00261443|141616407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.587||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Heart Rate||||0.587
71022856|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.67|||||TWO_SIDED|95.0|-151.27|77.94||||||For change in appetite loss at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||77.94|-151.27|
71022857|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.33|||||TWO_SIDED|95.0|-72.58|65.91||||||For change in constipation at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||65.91|-72.58|
71022858|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|73.33|||||TWO_SIDED|95.0|-16.45|163.12||||||For change in diarrhea at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||163.12|-16.45|
71022859|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.33|||||TWO_SIDED|95.0|-48.23|41.56||||||For change in financial difficulties at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||41.56|-48.23|
71022860|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.62|||||TWO_SIDED|95.0|-74.75|106.0||||||For change in global QoL at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||106.00|-74.75|
71022861|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.33|||||TWO_SIDED|95.0|-17.22|83.89||||||For change in physical functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||83.89|-17.22|
71022862|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.17|||||TWO_SIDED|95.0|-58.04|66.37||||||For change in role functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||66.37|-58.04|
71022863|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.21|||||TWO_SIDED|95.0|-28.19|38.61||||||For change in emotional functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||38.61|-28.19|
71056264|NCT00261443|141616407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.386||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in Heart Rate at Week 52 (LOCF)||||0.386
71056265|NCT00261443|141616407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.405||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Heart Rate, Phase 3||||0.405
71056266|NCT00261443|141616407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.253||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Value of Change in Heart Rate, Phase 3||||0.253
71056267|NCT00261443|141616408|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06||||0.514|TWO_SIDED|95.0|-0.12|0.23||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference||0.23|-0.12|0.514
71056268|NCT00261443|141616408|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12||||0.362|TWO_SIDED|95.0|-0.14|0.38||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value of Change Treatment Difference||0.38|-0.14|0.362
71056269|NCT00261443|141616409|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.904|TWO_SIDED|95.0|-0.04|0.04||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference||0.04|-0.04|0.904
71056270|NCT00261443|141616409|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04||||0.222|TWO_SIDED|95.0|-0.03|0.11||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value of Change Treatment Difference||0.11|-0.03|0.222
71056271|NCT00261443|141616410|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.808|TWO_SIDED|95.0|-0.03|0.04||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference||0.04|-0.03|0.808
71056272|NCT00261443|141616410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.771||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value of Change Treatment Difference||||0.771
71056273|NCT00261443|141616411|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01||||0.576|TWO_SIDED|95.0|-0.05|0.03||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference||0.03|-0.05|0.576
71056274|NCT00261443|141616411|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.636|TWO_SIDED|95.0|-0.05|0.08||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value treatment Difference||0.08|-0.05|0.636
70933894|NCT02434328|141368959|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.8|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||5.5|-2.8|
71056275|NCT00261443|141616412|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01||||0.774|TWO_SIDED|95.0|-0.06|0.08||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference||0.08|-0.06|0.774
71056276|NCT00261443|141616412|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.04||||0.444|TWO_SIDED|95.0|-0.06|0.14||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value of Change, Treatment Difference||0.14|-0.06|0.444
71056277|NCT02755649|141616426|SUPERIORITY||Difference in Percentages|29.5|||<|0.0001|TWO_SIDED|95.0|16.87|42.05||Threshold for significance at 0.05 level. P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by disease severity (IGA 3 vs IGA 4) and prior Cyclosporine A (CSA) use (Yes, No).|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across 2 dose regimens. Difference is Dupilumab minus placebo. Confidence Interval (CI) calculated using normal approximation. Participants with missing values at Week 16 were categorized as non-responders at Week 16. Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated.||42.05|16.87|< 0.0001
71056278|NCT02755649|141616426|SUPERIORITY||difference in percentages|33.0|||<|0.0001|TWO_SIDED|95.0|20.41|45.57||Threshold for significance at 0.05 level. P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by disease severity (IGA 3 vs IGA 4) and prior Cyclosporine A (CSA) use (Yes, No).|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across 2 dose regimens. Difference is Dupilumab minus placebo. Confidence Interval (CI) calculated using normal approximation. Participants with missing values at Week 16 were categorized as non-responders at Week 16. Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated.||45.57|20.41|< 0.0001
70933895|NCT02434328|141368959|OTHER||Difference of proportions|1.0|||||TWO_SIDED|95.0|-2.6|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||4.7|-2.6|
70933896|NCT02434328|141368959|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-4.0|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||4.3|-4.0|
70933897|NCT02434328|141368959|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-4.2|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||3.6|-4.2|
70933898|NCT02434328|141368959|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-4.0|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||3.7|-4.0|
70933899|NCT02434328|141368959|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-3.5|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.7|-3.5|
70933900|NCT02434328|141368959|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-4.5|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||3.4|-4.5|
71056279|NCT02755649|141616427|SUPERIORITY||Least square (LS) mean difference|-31.6|||<|0.0001|TWO_SIDED|95.0|-38.85|-24.3||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach to control Type-1 error rate at 0.05 across 2 dose regimens.CI w/p-value based on treatment difference(dupilumab vs placebo) of LS mean percent change using multiple imputation (MI) w/ANCOVA model w/baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use\[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI||-24.3|-38.85|< 0.0001
71056280|NCT02755649|141616427|SUPERIORITY||LS Mean Difference|-33.1|||<|0.0001|TWO_SIDED|95.0|-40.42|-25.88||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors. Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue \& then imputed by MI.||-25.88|-40.42|< 0.0001
71077927|NCT02913105|141664399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.91||||0.0105|TWO_SIDED|90.0|0.86|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 42||0.97|0.86|0.0105
70933901|NCT02434328|141368959|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-3.6|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.5|-3.6|
70933902|NCT02434328|141368959|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-4.5|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.6|-4.5|
70933903|NCT02434328|141368959|OTHER||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-5.7|2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||2.6|-5.7|
71077928|NCT02913105|141664399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.92||||0.0217|TWO_SIDED|90.0|0.86|0.98|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 56||0.98|0.86|0.0217
71077929|NCT02913105|141664399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.88||||0.0031|TWO_SIDED|90.0|0.82|0.94|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 84||0.94|0.82|0.0031
70933904|NCT02434328|141368959|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-4.9|3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||3.2|-4.9|
70933905|NCT02434328|141368960|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-3.5|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.5|-3.5|
70933906|NCT02434328|141368960|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-4.4|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||3.4|-4.4|
70933907|NCT02434328|141368960|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-5.0|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||3.1|-5.0|
71056281|NCT02755649|141616428|SUPERIORITY||LS mean difference|-26.2|||<|0.0001|TWO_SIDED|95.0|-35.07|-17.41||Threshold for significance at 0.05 level.|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI||-17.41|-35.07|< 0.0001
71056282|NCT02755649|141616428|SUPERIORITY||LS Mean Difference]|-28.5|||<|0.0001|TWO_SIDED|95.0|-37.34|-19.68||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-19.68|-37.34|< 0.0001
71056283|NCT02755649|141616429|SUPERIORITY||LS Mean Difference|-28.7|||<|0.0001|TWO_SIDED|95.0|-35.56|-21.93||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-21.93|-35.56|< 0.0001
71056284|NCT02755649|141616429|SUPERIORITY||LS Mean Difference|-32.9|||<|0.0001|TWO_SIDED|95.0|-39.7|-26.06||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-26.06|-39.7|< 0.0001
71077930|NCT02913105|141664399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.01||||0.774|TWO_SIDED|90.0|0.95|1.07|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 112 (EOS)||1.07|0.95|0.7740
70933908|NCT02434328|141368960|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-1.9|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||6.2|-1.9|
70933909|NCT02434328|141368960|OTHER||Difference in proportions|3.7|||||TWO_SIDED|95.0|-0.4|7.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||7.8|-0.4|
70933910|NCT02434328|141368960|OTHER||Difference in proportions|3.1|||||TWO_SIDED|95.0|-1.3|7.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Number of subjects with \>=5 letter loss from baseline in BCVA (letters read) at each post-baseline visit - Week 24||7.8|-1.3|
70933911|NCT02434328|141368960|OTHER||Difference in proportions|2.6|||||TWO_SIDED|95.0|-1.7|7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||7.3|-1.7|
70933912|NCT02434328|141368960|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-3.2|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||5.9|-3.2|
70933913|NCT02434328|141368960|OTHER||Difference in proportions|3.4|||||TWO_SIDED|95.0|-0.7|8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||8.3|-0.7|
70933914|NCT02434328|141368960|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-3.8|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||5.6|-3.8|
70933915|NCT02434328|141368960|OTHER||Difference in proportions|2.9|||||TWO_SIDED|95.0|-1.4|7.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||7.0|-1.4|
71056285|NCT02755649|141616430|SUPERIORITY||difference in percentages|26.1|||<|0.0001|TWO_SIDED|95.0|13.89|38.39||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||38.39|13.89|< 0.0001
71056286|NCT02755649|141616430|SUPERIORITY||difference in percentages|31.5|||<|0.0001|TWO_SIDED|95.0|19.08|43.83||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||43.83|19.08|< 0.0001
71056287|NCT02755649|141616431|SUPERIORITY||LS Mean Difference|-17.95|||<|0.0001|TWO_SIDED|95.0|-22.706|-13.197||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value is based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment,randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors. Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI||-13.197|-22.706|< 0.0001
71056288|NCT02755649|141616431|SUPERIORITY||LS Mean Difference|-19.66|||<|0.0001|TWO_SIDED|95.0|-24.431|-14.895||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-14.895|-24.431|< 0.0001
71056289|NCT02755649|141616432|SUPERIORITY||Difference in Percentages|25.2|||<|0.0001|TWO_SIDED|95.0|13.99|36.41||Threshold for significance at 0.05 level|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||36.41|13.99|< 0.0001
71056290|NCT02755649|141616432|SUPERIORITY||Difference in Percentages|26.3|||<|0.0001|TWO_SIDED|95.0|14.95|37.65||Threshold for significance at 0.05 level|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||37.65|14.95|< 0.0001
71056291|NCT02755649|141616433|SUPERIORITY||LS Mean Difference|-4.3|||<|0.0001|TWO_SIDED|95.0|-5.6|-3.04||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-3.04|-5.6|< 0.0001
71107755|NCT00518180|141721153|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given after Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup III minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|5.0|||||TWO_SIDED|95.0|1.0|10.0||||||Immune response to Men A when MenACWY is administered 1 month after Tdap, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||10|1|
70851642|NCT00265148|141191080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1337||||0.4159||95.0|-0.1931|0.4605|||Repeated measure mixed model|||For Grey matter, APOE Epsilon-4 status negative||0.4605|-0.1931|0.4159
70933916|NCT02434328|141368960|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-5.1|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||3.7|-5.1|
70851643|NCT00265148|141191080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1491||||0.2158|TWO_SIDED|95.0|-0.0897|0.3878|||Repeated measure mixed model|||For posterior cingulate gyrus, APOE Epsilon-4 status positive||0.3878|-0.0897|0.2158
70851644|NCT00265148|141191080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.2346||||0.2087|TWO_SIDED|95.0|-0.135|0.6042|||Repeated measure mixed model|||For posterior cingulate gyrus, APOE Epsilon-4 status negative||0.6042|-0.1350|0.2087
70933917|NCT02434328|141368960|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-2.5|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||6.7|-2.5|
70933918|NCT02434328|141368960|OTHER||Difference in proportions|1.8|||||TWO_SIDED|95.0|-2.8|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.4|-2.8|
70933919|NCT02434328|141368960|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-3.6|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||5.8|-3.6|
70933920|NCT02434328|141368960|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-4.0|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.4|-4.0|
70933921|NCT02434328|141368960|OTHER||Difference in proportions|1.8|||||TWO_SIDED|95.0|-2.8|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||6.4|-2.8|
70933922|NCT02434328|141368960|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-4.3|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||5.7|-4.3|
71056292|NCT02755649|141616433|SUPERIORITY||LS Mean Difference|-5.0|||<|0.0001|TWO_SIDED|95.0|-6.31|-3.74||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\])as fixed factors. Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-3.74|-6.31|< 0.0001
71077931|NCT02913105|141664399|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.95||||0.1783|TWO_SIDED|90.0|0.89|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 7||1.01|0.89|0.1783
70933923|NCT02434328|141368960|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-4.4|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||5.8|-4.4|
70933924|NCT02434328|141368960|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-6.0|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||3.6|-6.0|
70933925|NCT02434328|141368960|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-5.2|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.5|-5.2|
70933926|NCT02434328|141368960|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-5.7|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.6|-5.7|
70933927|NCT02434328|141368960|OTHER||Difference in proportions|-1.5|||||TWO_SIDED|95.0|-6.5|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||3.4|-6.5|
70933928|NCT02434328|141368960|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-5.1|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.8|-5.1|
71077932|NCT02913105|141664399|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.91||||0.0219|TWO_SIDED|90.0|0.84|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 14||0.97|0.84|0.0219
71077933|NCT02913105|141664399|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.92||||0.0719|TWO_SIDED|90.0|0.85|0.99|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 28||0.99|0.85|0.0719
70933929|NCT02434328|141368961|OTHER||Difference in proportions|-4.0|||||TWO_SIDED|95.0|-9.2|1.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||1.6|-9.2|
71107756|NCT00518180|141721153|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given after Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup III minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-1.0|||||TWO_SIDED|95.0|-6.0|4.0||||||Immune response to Men C when MenACWY is administered 1 month after Tdap, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||4|-6|
70851645|NCT00265148|141191080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1233||||0.3064|TWO_SIDED|95.0|-0.1162|0.3628|||Repeated measure mixed model|||For Frontal lobe, APOE Epsilon-4 status positive||0.3628|-0.1162|0.3064
70851646|NCT00265148|141191080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1734||||0.35|TWO_SIDED|95.0|-0.1952|0.542|||Repeated measure mixed model|||For Frontal lobe APOE Epsilon-4 status negative||0.5420|-0.1952|0.3500
70851647|NCT00265148|141191080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.13||||0.2487|TWO_SIDED|95.0|-0.0937|0.3538|||Repeated measure mixed model|||For parietal lobe, APOE Epsilon-4 status positive||0.3538|-0.0937|0.2487
70851648|NCT00265148|141191080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1038||||0.5521|TWO_SIDED|95.0|-0.244|0.4516|||Repeated measure mixed model|||For parietal lobe, APOE Epsilon-4 status negative||0.4516|-0.2440|0.5521
71022864|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.25|||||TWO_SIDED|95.0|-40.94|103.44||||||For change in cognitive functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||103.44|-40.94|
70851649|NCT00265148|141191080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1384||||0.176|TWO_SIDED|95.0|-0.064|0.3409|||Repeated measure mixed model|||For posterior temporal lobe, APOE Epsilon-4 status positive||0.3409|-0.0640|0.1760
70851650|NCT00265148|141191080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0837||||0.5952|TWO_SIDED|95.0|-0.2303|0.3978|||Repeated measure mixed model|||For posterior temporal lobe, APOE Epsilon-4 status negative||0.3978|-0.2303|0.5952
70851651|NCT00265148|141191080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0847||||0.4025|TWO_SIDED|95.0|-0.1169|0.2863|||Repeated measure mixed model|||For Cerebellum, APOE Epsilon-4 status positive||0.2863|-0.1169|0.4025
70851652|NCT00265148|141191080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1536||||0.3081|TWO_SIDED|95.0|-0.1458|0.453|||Repeated measure mixed model95|||For Cerebellum, APOE Epsilon-4 status negative||0.4530|-0.1458|0.3081
71022865|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.08|||||TWO_SIDED|95.0|-91.02|145.18||||||For change in social functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||145.18|-91.02|
71022866|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.28|||||TWO_SIDED|95.0|-99.46|68.9||||||For change in fatigue at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||68.90|-99.46|
71022867|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.0|||||TWO_SIDED|95.0|-69.69|19.69||||||For change in nausea and vomiting at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||19.69|-69.69|
71022868|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-77.4|77.4||||||For change in pain at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||77.40|-77.40|
71022869|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.29|||||TWO_SIDED|95.0|-82.89|54.32||||||For change in dyspnea at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||54.32|-82.89|
71022870|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.17|||||TWO_SIDED|95.0|-87.02|78.69||||||For change in insomnia at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||78.69|-87.02|
71022871|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.0|||||TWO_SIDED|95.0|-184.57|134.57||||||For change in appetite loss at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||134.57|-184.57|
71022872|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.33|||||TWO_SIDED|95.0|-105.73|89.06||||||For change in constipation at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||89.06|-105.73|
71022873|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|79.17|||||TWO_SIDED|95.0|-29.72|188.06||||||For change in diarrhea at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||188.06|-29.72|
71022874|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.17|||||TWO_SIDED|95.0|-57.74|49.41||||||For change in financial difficulties at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||49.41|-57.74|
71022875|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.67|||||TWO_SIDED|95.0|-39.62|72.95||||||For change in global QoL at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||72.95|-39.62|
71022876|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.62|||||TWO_SIDED|95.0|-6.42|61.66||||||For change in physical functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||61.66|-6.42|
71022877|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.19|||||TWO_SIDED|95.0|-29.28|81.66||||||For change in role functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||81.66|-29.28|
71022878|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.57|||||TWO_SIDED|95.0|-63.74|56.6||||||For change in emotional functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||56.6|-63.74|
71022879|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.81|||||TWO_SIDED|95.0|-31.66|79.28||||||For change in cognitive functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||79.28|-31.66|
71022880|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.57|||||TWO_SIDED|95.0|-53.82|110.96||||||For change in social functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||110.96|-53.82|
70933930|NCT02434328|141368961|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-8.1|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||3.7|-8.1|
70933931|NCT02434328|141368961|OTHER||Difference in proportions|-2.5|||||TWO_SIDED|95.0|-8.4|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||3.5|-8.4|
70933932|NCT02434328|141368961|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-5.4|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||6.7|-5.4|
70933933|NCT02434328|141368961|OTHER||Difference in proportions|-2.2|||||TWO_SIDED|95.0|-8.2|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||4.0|-8.2|
70933934|NCT02434328|141368961|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-9.0|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||3.3|-9.0|
71022881|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.16|||||TWO_SIDED|95.0|-94.53|34.21||||||For change in fatigue at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||34.21|-94.53|
71022882|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.67|||||TWO_SIDED|95.0|-83.26|49.93||||||For change in nausea and vomiting at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||49.93|-83.26|
71022883|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.76|||||TWO_SIDED|95.0|-97.98|88.45||||||For change in pain at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||88.45|-97.98|
71022884|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.11|||||TWO_SIDED|95.0|-86.68|64.46||||||For change in dyspnea at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||64.46|-86.68|
71022885|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.76|||||TWO_SIDED|95.0|-55.41|64.93||||||For change in insomnia at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||64.93|-55.41|
71022886|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.52|||||TWO_SIDED|95.0|-129.86|110.82||||||For change in appetite loss at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||110.82|-129.86|
71022887|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.05|||||TWO_SIDED|95.0|-117.92|79.82||||||For change in constipation at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||79.82|-117.92|
71022888|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|76.19|||||TWO_SIDED|95.0|-6.75|159.13||||||For change in diarrhea at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||159.13|-6.75|
71022889|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.76|||||TWO_SIDED|95.0|-64.93|55.41||||||For change in financial difficulties at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||55.41|-64.93|
71022890|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.56|||||TWO_SIDED|95.0|-271.74|260.62||||||For change in global QoL at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||260.62|-271.74|
71022891|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.56|||||TWO_SIDED|95.0|-166.87|197.98||||||For change in physical functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||197.98|-166.87|
71022892|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.78|||||TWO_SIDED|95.0|-238.4|293.96||||||For change in role functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||293.96|-238.4|
71022893|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.67|||||TWO_SIDED|95.0|-275.22|241.89||||||For change in emotional functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||241.89|-275.22|
71022894|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.56|||||TWO_SIDED|95.0|-307.94|319.05||||||For change in cognitive functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||319.05|-307.94|
71022895|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.78|||||TWO_SIDED|95.0|-238.4|293.96||||||For change in social functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||293.96|-238.40|
71022896|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.81|||||TWO_SIDED|95.0|-215.01|244.64||||||For change in fatigue at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||244.64|-215.01|
71022897|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.11|||||TWO_SIDED|95.0|-302.38|324.6||||||For change in nausea and vomiting at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||324.60|-302.38|
71022898|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.89|||||TWO_SIDED|95.0|-305.85|383.63||||||For change in pain at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||383.63|-305.85|
71022899|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.11|||||TWO_SIDED|95.0|-355.85|333.63||||||For change in dyspnea at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||333.63|-355.85|
71022900|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.22|||||TWO_SIDED|95.0|-322.52|366.97||||||For change in insomnia at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||366.97|-322.52|
71022901|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|44.44|||||TWO_SIDED|95.0|-208.53|297.42||||||For change in appetite loss at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||297.42|-208.53|
71022902|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-165.61|165.61||||||For change in constipation at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||165.61|-165.61|
70851653|NCT00265148|141191080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0839||||0.2964|TWO_SIDED|95.0|-0.0758|0.2436|||Repeated measure mixed model|||For medial temporal lobe, APOE Epsilon-4 status positive||0.2436|-0.0758|0.2964
70851654|NCT00265148|141191080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1536||||0.2101|TWO_SIDED|95.0|-0.0892|0.3963|||Repeated measure mixed model|||For medial temporal lobe, APOE Epsilon-4 status negative||0.3963|-0.0892|0.2101
70851655|NCT01068964|141191104|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 1.5 mmHg was used. That is, if the upper limit of the 95% confidence interval for the difference in the mean diurnal IOP change between the two groups (Group 1 minus Group 2) is less than 1.5 mm Hg, then the null hypothesis will be rejected. The study had an 85% power.|Mean Difference (Final Values)|-0.556|||||TWO_SIDED|95.0|-1.68|0.57||||||A non-inferiority test was performed for comparing the change from baseline in mean diurnal IOP at Week 4 between treatment groups. The null hypothesis was that the mean diurnal IOP change at Week 4 for Group 1 was at least 1.5 mmHg greater than that for Group 2. The hypothesis was tested using a confidence interval approach based on a 2-way analysis of variance (ANOVA) model including factors for treatment and investigator.||0.57|-1.68|
70851656|NCT03630770|141191112|OTHER||Rate Ratio|0.98||||0.9|TWO_SIDED|95.0|0.55|1.7||p-values underwent generalized estimating equations adjustment for multiple measures per individuals within time.|Negative binomial regression|||Stool fungal counts (cfu/g) were compared between groups using negative binomial regression within time period (before, during, after). Rate ratio was calculated to reflect the direction and magnitude of change in stool colony counts between time periods (before v. during supplementation) for the control group.||1.7|0.55|0.9
70851657|NCT03630770|141191112|OTHER||Rate Ratio|8.1|||<|0.001|TWO_SIDED|95.0|2.6|25.0||p-values underwent generalized estimating equations adjustment for multiple measures per individuals within time.|Negative binomial regression|||Stool fungal counts (cfu/g) were compared between groups using negative binomial regression within time period (before, during, after). Rate ratio was calculated to reflect the direction and magnitude of change in stool colony counts between time periods (during v. after supplementation) for the control group.||25|2.6|<0.001
70851658|NCT03630770|141191112|OTHER||Rate Ratio|0.15||||0.02|TWO_SIDED|95.0|0.03|0.75||p-values underwent generalized estimating equations adjustment for multiple measures per individuals within time.|Negative binomial regression|||Stool fungal counts (cfu/g) were compared between groups using negative binomial regression within time period (before, during, after). Rate ratio was calculated to reflect the direction and magnitude of change in stool colony counts between time periods (before v. during supplementation) for the MCT group.||0.75|0.03|0.02
70851659|NCT03630770|141191112|OTHER||Rate Ratio|61.0|||<|0.001|TWO_SIDED|95.0|6.9|533.0||p-values underwent generalized estimating equations adjustment for multiple measures per individuals within time.|Negative binomial regression|||Stool fungal counts (cfu/g) were compared between groups using negative binomial regression within time period (before, during, after). Rate ratio was calculated to reflect the direction and magnitude of change in stool colony counts between time periods (during v. after supplementation) for the MCT group.||533|6.9|<0.001
70851660|NCT01523275|141191113|EQUIVALENCE|Analysis of 44 subjects (22 in each arm) would provide 90% power to detect a difference in the time interval to reoperation of 6 months between the two treatment arms, at an alpha level of 0.05. This difference of 6 months is clinically meaningful and is smaller than previous case series studies would suggest. However, due to poor patient accrual, the study was closed prior to reaching the desired study size.||||||0.95|||||||t-test, 2 sided|||||||0.95
70851661|NCT01523275|141191114|EQUIVALENCE|A difference of 6 months to symptom progression is clinically meaningful.||||||0.52|||||||t-test, 2 sided|||||||0.52
70851662|NCT01523275|141191115|EQUIVALENCE|0.5 liters per second is clinically significant.||||||0.64|||||||t-test, 2 sided|||||||0.64
71022903|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|77.78|||||TWO_SIDED|95.0|-17.84|173.39||||||For change in diarrhea at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||173.39|-17.84|
71022904|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.11|||||TWO_SIDED|95.0|-106.73|84.5||||||For change in financial difficulties at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||84.5|-106.73|
71022905|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-54.17|||||TWO_SIDED|95.0|-512.66|404.33||||||For change in global QoL at EoS, mean change difference was used to compare the two treatment groups.||404.33|-512.66|
71022906|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-70.0|||||TWO_SIDED|95.0|-143.36|3.36||||||For change in physical functioning at EoS, mean change difference was used to compare the two treatment groups.||3.36|-143.36|
71022907|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.33|||||TWO_SIDED|95.0|-400.13|333.46||||||For change in role functioning at EoS, mean change difference was used to compare the two treatment groups.||333.46|-400.13|
71022908|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.67|||||TWO_SIDED|95.0|-591.86|508.53||||||For change in emotional functioning at EoS, mean change difference was used to compare the two treatment groups.||508.53|-591.86|
70851663|NCT00689117|141191118|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||Inflammatory lesion count|Ranked ANCOVA|||||||0.063
70851664|NCT00689117|141191118|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Inflammatory lesion count|Ranked ANCOVA|||||||0.003
70851665|NCT00689117|141191118|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Inflammatory lesion count|Ranked ANCOVA|||||||<0.001
70851666|NCT00689117|141191118|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||Non-inflammatory lesion count|Ranked ANCOVA|||||||0.004
70851667|NCT00689117|141191118|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||Non-inflammatory lesion count|Ranked ANCOVA|||||||0.550
70851668|NCT00689117|141191118|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Non-inflammatory lesion count|Ranked ANCOVA|||||||<0.001
70851669|NCT00689117|141191118|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total lesion count|Ranked ANCOVA|||||||<0.001
71107757|NCT00518180|141721153|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given after Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup III minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-16.0|||||TWO_SIDED|95.0|-21.0|-10.0||||||Immune response to Men W when MenACWY is administered 1 month after Tdap, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||-10|-21|
71056293|NCT02755649|141616434|SUPERIORITY||LS Mean Difference|-7.1|||<|0.0001|TWO_SIDED|95.0|-8.78|-5.47||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\])as fixed factors. Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-5.47|-8.78|< 0.0001
71056294|NCT02755649|141616434|SUPERIORITY||LS Mean Difference|-7.6|||<|0.0001|TWO_SIDED|95.0|-9.29|-5.97||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\])as fixed factors. Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-5.97|-9.29|< 0.0001
71056295|NCT02755649|141616435|SUPERIORITY||Difference in Percentages|30.1|||=|0.0002|TWO_SIDED|95.0|14.63|45.64||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||45.64|14.63|= 0.0002
71056296|NCT02755649|141616435|SUPERIORITY||Difference in Percentages|31.6|||=|0.0001|TWO_SIDED|95.0|16.11|47.05||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||47.05|16.11|= 0.0001
71056297|NCT02755649|141616436|SUPERIORITY||LS Mean Difference|-7.6|||=|0.0003|TWO_SIDED|95.0|-11.64|-3.51||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-3.51|-11.64|= 0.0003
71056298|NCT02755649|141616436|SUPERIORITY||LS Mean Difference|-10.1|||<|0.0001|TWO_SIDED|95.0|-14.15|-5.95||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-5.95|-14.15|< 0.0001
71056299|NCT02755649|141616437|SUPERIORITY||LS Mean Difference|-2.9|||=|0.0001|TWO_SIDED|95.0|-4.41|-1.43||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-1.43|-4.41|= 0.0001
71056300|NCT02755649|141616437|SUPERIORITY||LS Mean Difference|-3.9|||<|0.0001|TWO_SIDED|95.0|-5.38|-2.4||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-2.4|-5.38|< 0.0001
71056301|NCT02755649|141616438|SUPERIORITY||Difference in Percentages|29.5|||<|0.0001|TWO_SIDED|95.0|17.1|41.96||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||41.96|17.1|< 0.0001
71107758|NCT00518180|141721153|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given after Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup III minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-4.0|||||TWO_SIDED|95.0|-9.0|1.0||||||Immune response to Men Y when MenACWY is administered 1 month after Tdap, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||1|-9|
70933935|NCT02434328|141368961|OTHER||Difference in proportions|-3.2|||||TWO_SIDED|95.0|-9.3|2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.5|-9.3|
70933936|NCT02434328|141368961|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-9.6|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||2.8|-9.6|
71056302|NCT02755649|141616438|SUPERIORITY||Difference in Percentages|40.4|||<|0.0001|TWO_SIDED|95.0|28.24|52.61||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||52.61|28.24|< 0.0001
71056303|NCT02755649|141616439|SUPERIORITY||LS Mean Difference|-24.3|||<|0.0001|TWO_SIDED|95.0|-31.63|-16.88||Threshold for significance at 0.05 level.|ANCOVA|||A hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab group vs. placebo)of LS mean percent change using MI with ANCOVA with baseline measurement as covariate \& treatment,randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use\[Yes,No\])as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-16.88|-31.63|< 0.0001
71056304|NCT02755649|141616439|SUPERIORITY||LS Mean Difference|-26.2|||<|0.0001|TWO_SIDED|95.0|-33.49|-18.86||Threshold for significance at 0.05 level.|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata (disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-18.86|-33.49|< 0.0001
71056305|NCT02755649|141616440|SUPERIORITY||LS Mean Difference|-9.7|||=|0.0017|TWO_SIDED|95.0|-15.8|-3.66||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens. CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-3.66|-15.8|= 0.0017
71056306|NCT02755649|141616440|SUPERIORITY||LS Mean Difference|-7.2|||=|0.0214|TWO_SIDED|95.0|-13.31|-1.06||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-1.06|-13.31|= 0.0214
71056307|NCT02755649|141616441|SUPERIORITY||Difference in Percentages|-4.7|||=|0.1486|TWO_SIDED|95.0|-10.97|1.58|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||1.58|-10.97|= 0.1486
71056308|NCT02755649|141616441|SUPERIORITY||Difference in Percentages|-6.5|||=|0.0319|TWO_SIDED|95.0|-12.27|-0.65|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||-0.65|-12.27|= 0.0319
71056309|NCT02755649|141616442|SUPERIORITY||difference in percentages|0.0|||=|0.9829|TWO_SIDED|95.0|-3.6|3.53|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||3.53|-3.6|= 0.9829
71056310|NCT02755649|141616442|SUPERIORITY||difference in percentages|0.0|||=|1|TWO_SIDED|95.0|-3.6|3.63|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||3.63|-3.6|= 1
70933937|NCT02434328|141368961|OTHER||Difference in proportions|-3.7|||||TWO_SIDED|95.0|-9.6|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||2.2|-9.6|
70851670|NCT00689117|141191118|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||Total lesion count|Ranked ANCOVA|||||||0.016
70933938|NCT02434328|141368961|OTHER||Difference in proportions|-1.7|||||TWO_SIDED|95.0|-7.6|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||4.2|-7.6|
70933939|NCT02434328|141368961|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-7.5|5.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||5.0|-7.5|
70933940|NCT02434328|141368961|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-5.4|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||6.1|-5.4|
71056311|NCT02755649|141616443|SUPERIORITY||difference in percentages|0.9|||=|0.5619|TWO_SIDED|95.0|-2.19|3.97|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||3.97|-2.19|= 0.5619
71056312|NCT02755649|141616443|SUPERIORITY||difference in percentages|-0.9|||=|0.3241|TWO_SIDED|95.0|-2.73|0.88|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||0.88|-2.73|= 0.3241
71056313|NCT02755649|141616444|SUPERIORITY||difference in percentages|-0.4|||=|0.9518|TWO_SIDED|95.0|-12.6|11.9|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||11.9|-12.6|= 0.9518
71056314|NCT02755649|141616444|SUPERIORITY||difference in percentages|2.5|||=|0.6833|TWO_SIDED|95.0|-9.64|14.68|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||14.68|-9.64|= 0.6833
71056315|NCT02657928|141616454|SUPERIORITY|||||||0.5004|||||||Log Rank|||||||0.5004
71056316|NCT02657928|141616455|SUPERIORITY|||||||0.9127|||||||Log Rank|||||||0.9127
71056317|NCT02119819|141616467|SUPERIORITY||Posterior Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.16||0.459|TWO_SIDED|90.0|-1.05|-0.52|||Bayesian|||||-0.52|-1.05|0.459
71056318|NCT02119819|141616467|SUPERIORITY||Posterior Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.16||0.511|TWO_SIDED|90.0|-1.07|-0.54|||Bayesian|||||-0.54|-1.07|0.511
71056319|NCT02119819|141616467|SUPERIORITY||Posterior Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.16||0.988|TWO_SIDED|90.0|-1.41|-0.89|||Bayesian|||||-0.89|-1.41|0.988
71056320|NCT02119819|141616467|SUPERIORITY||Posterior Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.16||0.934|TWO_SIDED|90.0|-1.3|-0.78|||Bayesian|||||-0.78|-1.30|0.934
71056321|NCT02119819|141616467|SUPERIORITY||Posterior Mean Difference|0.35|STANDARD_ERROR_OF_MEAN|0.16||0.373|TWO_SIDED|90.0|0.08|0.61|||Bayesian|||||0.61|0.08|0.373
71056322|NCT02119819|141616467|SUPERIORITY||Posterior Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.16||0.433|TWO_SIDED|90.0|0.07|0.59|||Bayesian|||||0.59|0.07|0.433
71056323|NCT02119819|141616467|SUPERIORITY||Posterior Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.16||0.978|TWO_SIDED|90.0|-0.28|0.24|||Bayesian|||||0.24|-0.28|0.978
71056324|NCT02119819|141616467|SUPERIORITY||Posterior Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.16||0.904|TWO_SIDED|90.0|-0.17|0.35|||Bayesian|||||0.35|-0.17|0.904
71056325|NCT01917214|141616501|SUPERIORITY_OR_OTHER|||||||0.0308|||||||Log Rank|||||||0.0308
71056326|NCT00926783|141616505|SUPERIORITY_OR_OTHER|||||||0.048||||||The p-value was based on Fisher's exact test. There were no adjustments for multiple comparisons.|Fisher Exact|||The null hypothesis is that rates of free from atrial arrhythmia for the two arms, Targeted and Generalized, are the same. The alternative hypothesis is that the rates are not the same. Due to the lack of literature data comparing these endpoints between two randomization groups, the sample size is not statistically powered to support statistical inferences.||||0.048
71056327|NCT00926783|141616506|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||The null hypothesis is that the total RF delivery times for both arms are equal. The alternative hypothesis is that the total RF delivery times are not equal. Due to the lack of literature data comparing these endpoints between two randomization groups, the sample size is not statistically powered to support statistical inferences.||||0.002
71056328|NCT01191944|141616522|NON_INFERIORITY_OR_EQUIVALENCE|pre-specified non-inferiority (NI) margin of -4 points|Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.9192|<|0.0001||95.0|-1.047|2.566||one-sided test relative to NI margin of -4|ANCOVA|adjusted for treatment, centre and baseline|Pramipexole IR minus Pramipexole ER, Pramipexole ER non inferior to Pramipexole IR if lower limit of confidence interval (CI) for the mean difference is higher than NI margin.|The null hypothesis (H0) states that the mean change from baseline to Week 18 (or last observation carried forward \[LOCF\]) in the UPDRS II+III score for the treatment group pramipexole ER is inferior to the mean change for the treatment group pramipexole IR.||2.566|-1.047|<0.0001
71056329|NCT01191944|141616523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|2.1836||0.8261|TWO_SIDED|95.0|-4.787|3.826|||ANCOVA|||||3.826|-4.787|0.8261
71056330|NCT01191944|141616524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.3274||0.8698|TWO_SIDED|95.0|-0.699|0.592|||ANCOVA|||||0.592|-0.699|0.8698
71056331|NCT01191944|141616525|SUPERIORITY_OR_OTHER|||||||0.7902||95.0|||||Cochran-Mantel-Haenszel|||||||0.7902
71056332|NCT01191944|141616526|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.763|STANDARD_ERROR_OF_MEAN|2.7845||0.3223|TWO_SIDED|95.0|-8.255|2.729|||ANCOVA|||||2.729|-8.255|0.3223
71056333|NCT01191944|141616527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.51|STANDARD_ERROR_OF_MEAN|1.5581||0.0254|TWO_SIDED|95.0|0.437|6.583|||ANCOVA|||||6.583|0.437|0.0254
71056334|NCT01191944|141616528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.621|STANDARD_ERROR_OF_MEAN|2.2658||0.7843|TWO_SIDED|95.0|-3.848|5.09|||ANCOVA|||||5.090|-3.848|0.7843
71056335|NCT01191944|141616529|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.369|STANDARD_ERROR_OF_MEAN|0.4901||0.4529|TWO_SIDED|95.0|-0.598|1.335|||ANCOVA|||||1.335|-0.598|0.4529
71056336|NCT01191944|141616530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.4437||0.2338|TWO_SIDED|95.0|-1.405|0.345|||ANCOVA|||||0.345|-1.405|0.2338
71056337|NCT01191944|141616531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.562|STANDARD_ERROR_OF_MEAN|0.2509||0.0263|TWO_SIDED|95.0|0.067|1.057|||ANCOVA|||||1.057|0.067|0.0263
71056338|NCT01191944|141616532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.3727||0.9337|TWO_SIDED|95.0|-0.704|0.766|||ANCOVA|||||0.766|-0.704|0.9337
71056339|NCT01191944|141616533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.0798||0.6995|TWO_SIDED|95.0|-0.127|0.188|||ANCOVA|||||0.188|-0.127|0.6995
71056340|NCT01191944|141616534|SUPERIORITY_OR_OTHER|||||||0.317||95.0|||||Cochran-Mantel-Haenszel|||||||0.3170
71056341|NCT01191944|141616535|SUPERIORITY_OR_OTHER|||||||0.4756||95.0|||||Cochran-Mantel-Haenszel|||||||0.4756
71056342|NCT01191944|141616536|SUPERIORITY_OR_OTHER|||||||0.1051||95.0|||||Cochran-Mantel-Haenszel|||||||0.1051
71107759|NCT00518180|141721154|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority of the immune response to Tdap when administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone, was demonstrated for the diphteria and tetanus antigens if the lower limits of the two-sided 95% CIs around the difference in the percentages of subjects with ELISA anti-D toxin ≥ 1.0 IU/mL \[Group I minus Group III\] were greater than -10%.|Vaccine Group differences (%)|2.0|||||TWO_SIDED|95.0|1.0|4.0||||||Non inferiority of the immune response to diphteria antigen, when Tdap is administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||4|1|
71056343|NCT01191944|141616537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.3138||0.6237|TWO_SIDED|95.0|-0.463|0.771|||ANCOVA|||||0.771|-0.463|0.6237
71056344|NCT01191944|141616539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.628|STANDARD_ERROR_OF_MEAN|0.7088||0.376|TWO_SIDED|95.0|-0.765|2.021|||ANCOVA|||||2.021|-0.765|0.3760
71056345|NCT02814890|141616542|OTHER|difference test||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Sample size: Based on our previous data, pain score at rest 48 hours postoperatively when using ropivacaine only was of 2.8 with a standard deviation of 1.4. Assuming a decrease of pain score by 1.1 being clinically significant, twenty six patents in each group would be required for a study power of 80% (α=0.05,β=0.2). Considering possible dropouts, we aimed at recruiting 30 patients in each group with a total of 60 patients.||||0.001
71056346|NCT02814890|141616543|OTHER|difference test|Kendall's tau-b correlation coefficient|0.47|||||TWO_SIDED|||||||||||||
71056347|NCT02814890|141616545|SUPERIORITY||Risk Ratio (RR)|0.64|||>|0.05|TWO_SIDED||||||Fisher Exact|||||||>0.05
71056348|NCT00469144|141616561|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||100 Days, Between Arms: Participants in CR||||0.9
71056349|NCT00469144|141616561|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||100 Days, Between Arms: Participants not in CR||||0.4
71056350|NCT00469144|141616561|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||1 Year, Between Arms: Participants in CR||||0.7
71056351|NCT00469144|141616561|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||1 Year, Between Arms: Participants not in CR||||0.05
71056352|NCT00000620|141616575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.12|TWO_SIDED|95.0|0.81|1.03||P-value presented is not adjusted for multiple comparisons. A priori significance level was 0.05.|Regression, Cox|||Adjustment performed for the following pre-specified factors: sub-trial assignment (Blood Pressure Trial or Lipid Trial), assignment to intensive BP group in BP Trial, assignment to fenofibrate group in Lipid Trial, the seven clinical center networks, and presence of clinical cardiovascular disease at baseline.||1.03|0.81|0.12
71056353|NCT00000620|141616576|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.02|TWO_SIDED|95.0|1.03|1.38||P-value presented is not adjusted for multiple comparisons. A priori significance level was 0.05.|Regression, Cox|||Adjustment performed for the following pre-specified factors: sub-trial assignment (Blood Pressure Trial or Lipid Trial), assignment to intensive BP group in BP Trial, assignment to fenofibrate group in Lipid Trial, the seven clinical center networks, and presence of clinical cardiovascular disease at baseline.||1.38|1.03|0.02
71056354|NCT00000620|141616577|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.2|TWO_SIDED|95.0|0.73|1.06||P-value is adjusted for interim monitoring. A priori significance level was 0.05.|Regression, Cox|Adjustment for the seven clinical center networks and presence of clinical cardiovascular disease at baseline as pre-specified in the study protocol.||Recruitment for the Blood PressureTrial was designed to enroll 4200 participant to have 94% power to detect a 20% reduction in the rate of MCE for patients in the intensive-therapy group as compared with the standard-therapy group, assuming a two-sided alpha level of 0.05, a primary-outcome rate of 4% per year in the standard-therapy group, and a planned average follow-up of approximately 5.6 years.||1.06|0.73|0.20
71056355|NCT00000620|141616578|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59||||0.01|TWO_SIDED|95.0|0.39|0.89||P-value presented is not adjusted for multiple comparisons. A priori significance level was 0.05.|Regression, Cox|Adjustment for the seven clinical center networks and presence of clinical cardiovascular disease at baseline as pre-specified in the study protocol.||||0.89|0.39|0.01
70933941|NCT02434328|141368961|OTHER||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-7.7|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.5|-7.7|
70933942|NCT02434328|141368961|OTHER||Difference in proportions|-1.9|||||TWO_SIDED|95.0|-7.7|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||4.0|-7.7|
70933943|NCT02434328|141368961|OTHER||Difference in proportions|-4.7|||||TWO_SIDED|95.0|-10.8|1.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||1.4|-10.8|
70933944|NCT02434328|141368961|OTHER||Difference in proportions|-2.8|||||TWO_SIDED|95.0|-8.9|3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||3.2|-8.9|
70933945|NCT02434328|141368961|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-9.5|2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||2.9|-9.5|
70933946|NCT02434328|141368961|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-7.9|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||4.5|-7.9|
71107760|NCT00518180|141721154|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority of the immune response to Tdap when administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone, was demonstrated for the diphteria and tetanus antigens if the lower limits of the two-sided 95% CIs around the difference in the percentages of subjects with ELISA anti-D toxin ≥ 1.0 IU/mL \[Group I minus Group III\] were greater than -10%.|Vaccine Group differences (%)|0.0|||||TWO_SIDED|95.0|-1.0|1.0||||||Non inferiority of the immune response to tetanus antigen, when Tdap is administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||1|-1|
71107761|NCT00518180|141721163|NON_INFERIORITY_OR_EQUIVALENCE|Tdap concomitant with MenACWY a was considered non inferior to Tdap alone if, for PT, FHA and pertactin, the lower limit of the two-sided 95% CI for the ratio of the GMCs (GMC Group I / GMC Group III) at 1 month after vaccination was \> 0.67.|Vaccine Group Ratio|0.8|||||TWO_SIDED|95.0|0.72|0.9||||||Non inferiority of the immune response to Tdap is administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone, for PT antigen. Method: ANCOVA. Parameter estimate: Vaccine Group Ratio.||0.9|0.72|
70933947|NCT02434328|141368961|OTHER||Difference in proportions|-2.0|||||TWO_SIDED|95.0|-8.1|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.1|-8.1|
71107762|NCT00518180|141721163|NON_INFERIORITY_OR_EQUIVALENCE|Tdap concomitant with MenACWY a was considered non inferior to Tdap alone if, for PT, FHA and pertactin, the lower limit of the two-sided 95% CI for the ratio of the GMCs (GMC Group I / GMC Group III) at 1 month after vaccination was \> 0.67.|Vaccine Group Ratio|0.68|||||TWO_SIDED|95.0|0.58|0.81||||||Non inferiority of the immune response to Tdap when administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone, for PRN antigen. Method: ANCOVA. Parameter estimate: Vaccine Group Ratio.||0.81|0.58|
71107763|NCT00518180|141721163|NON_INFERIORITY_OR_EQUIVALENCE|Tdap concomitant with MenACWY a was considered non inferior to Tdap alone if, for PT, FHA and pertactin, the lower limit of the two-sided 95% CI for the ratio of the GMCs (GMC Group I / GMC Group III) at 1 month after vaccination was \> 0.67.|Vaccine Group Ratio|0.67|||||TWO_SIDED|95.0|0.58|0.76||||||Non inferiority of the immune response to Tdap when administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alon, for FHA antigen. Method: ANCOVA. Parameter estimate: Vaccine Group Ratio.||0.76|0.58|
70933948|NCT02434328|141368961|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-5.6|6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.6|-5.6|
70933949|NCT02434328|141368961|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.3|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||3.8|-8.3|
71107764|NCT03060902|141721166|SUPERIORITY||F|10.16||||0.002|TWO_SIDED||||||ANOVA|||||||.002
71107765|NCT02972996|141721196|OTHER|||||||0.56|||||||ANCOVA|||Values are least-squares means ± SEs (adjusted for the baseline values) from ANCOVA linear mixed model that included covariates of age, baseline (pretreatment values), BMI and weight.||||0.56
70933950|NCT02434328|141368961|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-7.4|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||4.5|-7.4|
71107766|NCT02972996|141721197|OTHER|||||||0.03|||||||ANCOVA|||||||0.03
71107767|NCT03961308|141721215|OTHER|Geometric least-squares means (LSMs) were calculated by exponentiating the LSMs derived from analysis of covariance (ANCOVA) with weight as a covariate. Confidence intervals (CIs) were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|1.0734|||||TWO_SIDED|90.0|0.9963|1.1565||||||||1.1565|0.9963|
71107768|NCT03961308|141721216|OTHER|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|1.0824|||||TWO_SIDED|90.0|1.0169|1.1521||||||||1.1521|1.0169|
71107769|NCT03961308|141721217|OTHER|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|1.0465|||||TWO_SIDED|90.0|0.9935|1.1023||||||||1.1023|0.9935|
71107770|NCT01174563|141721231|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.005|TWO_SIDED|95.0|0.41|0.83|||Log Rank|||||0.83|0.41|0.005
71107771|NCT01347060|141721242|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.0051|TWO_SIDED|95.0|0.68|0.93||The P-value relates to differences in combined inpatient/emergency department.|Regression, Cox|Adjusted for baseline differences||||0.93|0.68|0.0051
70933951|NCT02434328|141368961|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-6.5|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||5.8|-6.5|
70933952|NCT02434328|141368961|OTHER||Difference in proportions|-2.0|||||TWO_SIDED|95.0|-8.1|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.1|-8.1|
70933953|NCT02434328|141368962|OTHER|Treatment difference|Least Squares Mean Difference|-17.7|STANDARD_ERROR_OF_MEAN|7.57|||TWO_SIDED|95.0|-32.6|-2.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4||-2.9|-32.6|
70933954|NCT02434328|141368962|OTHER|Treatment difference|Least Squares Mean Difference|-29.5|STANDARD_ERROR_OF_MEAN|8.18|||TWO_SIDED|95.0|-45.6|-13.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8||-13.4|-45.6|
70933955|NCT02434328|141368962|OTHER|Treatment difference|Least Squares Mean Difference|-30.3|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-46.9|-13.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||-13.7|-46.9|
70933956|NCT02434328|141368962|OTHER|Treatment difference|Least Squares Mean Difference|-40.2|STANDARD_ERROR_OF_MEAN|9.51|||TWO_SIDED|95.0|-58.9|-21.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16||-21.6|-58.9|
71107772|NCT01347060|141721243|SUPERIORITY_OR_OTHER||Mean Difference (Net)|883.23||||0.001|TWO_SIDED|95.0|731.66|1041.69||The P-value is on the adjusted difference in total asthma costs.|Regression, Linear|Generalized Linear Model with a log-link and a gamma distribution adjusting for differences at baseline||||1041.69|731.66|0.001
71107773|NCT01347060|141721244|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71107774|NCT01542788|141721251|SUPERIORITY_OR_OTHER||Proportion difference|77.3|||<|0.001|TWO_SIDED|95.0|71.0|83.6||P-value is from the Cochran-Mantel-Haenszel test stratified by presence or absence of cirrhosis for the superiority of SOF+RBV over placebo.|Cochran-Mantel-Haenszel||The difference in proportions between treatment groups and associated 95% confidence interval (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions.|A sample size of 180 subjects in the active group and 60 in the placebo group would provide 99% power to detect a difference between group SVR12 rates of 40% using a 2-sided continuity-corrected chi-square test at significance level of 0.05.||83.6|71.0|< 0.001
71107775|NCT01542788|141721253|SUPERIORITY_OR_OTHER||Proportion difference|82.7|||||TWO_SIDED|95.0|76.8|88.5|||||The difference in proportions between treatment groups and associated 95% CI are calculated based on stratum-adjusted Mantel-Haenszel proportions.|||88.5|76.8|
71107776|NCT01542788|141721254|SUPERIORITY_OR_OTHER||Proportion difference|77.3|||<|0.001|TWO_SIDED|95.0|71.0|83.6||P-value is from the Cochran-Mantel-Haenszel test stratified by randomization stratification factor for the superiority of SOF+RBV over placebo.|Cochran-Mantel-Haenszel||The difference in proportions between treatment groups and associated 95% CI are calculated based on stratum-adjusted Mantel-Haenszel proportions.|||83.6|71.0|< 0.001
70851671|NCT00689117|141191118|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total lesion count|Ranked ANCOVA|||||||<0.001
71107777|NCT04704193|141721261|OTHER|This arm includes descriptive statistics only.|count with proportion|0.955|||||TWO_SIDED|95.0|0.888|0.987||||||"Descriptive statistics only/proportion reported good or excellent~Q1a. Genetic testing is a blood test that looks for mutations in genes that can increase cancer risk"||.987|.888|
71107778|NCT04704193|141721261|OTHER|This arm includes descriptive statistics only.|count with proportion|0.931|||||TWO_SIDED|95.0|0.856|0.974||||||"Descriptive statistics only/proportion reported good or excellent~Q1b. Genetic test results may help guide my treatment options"||.974|.856|
71107779|NCT04704193|141721261|OTHER|This arm includes descriptive statistics only.|count with proportion|0.943|||||TWO_SIDED|95.0|0.872|0.981||||||"Descriptive statistics only/proportion reported good or excellent~Q1c. Genetic test results may help me understand the future risks of other cancers"||.981|.872|
70933957|NCT02434328|141368962|OTHER|Treatment difference|Least Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|9.12|||TWO_SIDED|95.0|-20.9|15.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20||15.0|-20.9|
70933958|NCT02434328|141368962|OTHER|Treatment difference|Least Squares Mean Difference|-47.8|STANDARD_ERROR_OF_MEAN|9.42|||TWO_SIDED|95.0|-66.3|-29.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||-29.3|-66.3|
70933959|NCT02434328|141368962|OTHER|Treatment difference|Least Squares Mean Difference|-23.7|STANDARD_ERROR_OF_MEAN|9.34|||TWO_SIDED|95.0|-42.0|-5.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28||-5.4|-42.0|
70933960|NCT02434328|141368962|OTHER|Treatment difference|Least Squares Mean Difference|-33.7|STANDARD_ERROR_OF_MEAN|9.54|||TWO_SIDED|95.0|-52.4|-15.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32||-15.0|-52.4|
70933961|NCT02434328|141368962|OTHER|Treatment difference|Least Squares Mean Difference|-30.4|STANDARD_ERROR_OF_MEAN|8.94|||TWO_SIDED|95.0|-48.0|-12.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36||-12.9|-48.0|
70933962|NCT02434328|141368962|OTHER|Treatment difference|Least Squares Mean Difference|-44.7|STANDARD_ERROR_OF_MEAN|9.57|||TWO_SIDED|95.0|-63.5|-25.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40||-25.9|-63.5|
70933963|NCT02434328|141368962|OTHER|Treatment difference|Least Squares Mean Difference|-19.2|STANDARD_ERROR_OF_MEAN|9.24|||TWO_SIDED|95.0|-37.3|-1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44||-1.1|-37.3|
70933964|NCT02434328|141368962|OTHER|Treatment difference|Least Squares Mean Difference|-49.9|STANDARD_ERROR_OF_MEAN|9.68|||TWO_SIDED|95.0|-68.9|-30.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||-30.9|-68.9|
70933965|NCT02434328|141368962|OTHER|Treatment difference|Least Squares Mean Difference|-28.1|STANDARD_ERROR_OF_MEAN|9.01|||TWO_SIDED|95.0|-45.8|-10.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52||-10.4|-45.8|
70933966|NCT02434328|141368962|OTHER|Treatment difference|Least Squares Mean Difference|-43.1|STANDARD_ERROR_OF_MEAN|9.86|||TWO_SIDED|95.0|-62.4|-23.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56||-23.7|-62.4|
70933967|NCT02434328|141368962|OTHER|Treatment difference|Least Squares Mean Difference|-31.1|STANDARD_ERROR_OF_MEAN|9.34|||TWO_SIDED|95.0|-49.5|-12.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60||-12.8|-49.5|
70933968|NCT02434328|141368962|OTHER|Treatment difference|Least Squares Mean Difference|-45.8|STANDARD_ERROR_OF_MEAN|9.7|||TWO_SIDED|95.0|-64.9|-26.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64||-26.8|-64.9|
70933969|NCT02434328|141368962|OTHER|Treatment difference|Least Squares Mean Difference|-23.7|STANDARD_ERROR_OF_MEAN|9.31|||TWO_SIDED|95.0|-42.0|-5.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68||-5.4|-42.0|
70933970|NCT02434328|141368962|OTHER|Treatment difference|Least Squares Mean Difference|-47.3|STANDARD_ERROR_OF_MEAN|9.69|||TWO_SIDED|95.0|-66.4|-28.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||-28.3|-66.4|
70851672|NCT00689117|141191119|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Data based on Data on File documenting FDA reanalysis request|Cochran-Mantel-Haenszel|||||||0.001
70933971|NCT02434328|141368962|OTHER|Treatment difference|Least Squares Mean Difference|-28.0|STANDARD_ERROR_OF_MEAN|9.43|||TWO_SIDED|95.0|-46.5|-9.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76||-9.5|-46.5|
70933972|NCT02434328|141368962|OTHER|Treatment difference|Least Squares Mean Difference|-40.9|STANDARD_ERROR_OF_MEAN|9.94|||TWO_SIDED|95.0|-60.4|-21.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80||-21.4|-60.4|
70933973|NCT02434328|141368962|OTHER|Treatment difference|Least Squares Mean Difference|-31.0|STANDARD_ERROR_OF_MEAN|9.48|||TWO_SIDED|95.0|-49.6|-12.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84||-12.4|-49.6|
71022909|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-66.67|||||TWO_SIDED|95.0|-66.67|-66.67||||||For change in cognitive functioning at EoS, mean change difference was used to compare the two treatment groups.||-66.67|-66.67|
70851673|NCT00689117|141191119|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Data based on Data on File documenting FDA reanalysis request|Cochran-Mantel-Haenszel|||||||<0.001
70851674|NCT00689117|141191119|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Data based on Data on File documenting FDA reanalysis request|Cochran-Mantel-Haenszel|||||||<0.001
71107780|NCT04704193|141721261|OTHER|This arm includes descriptive statistics only.|count with proportion|0.851|||||TWO_SIDED|95.0|0.758|0.918||||||"Descriptive statistics only/proportion reported good or excellent~Q1d. Genetic test results may increase stress to me and my family members"||.918|.758|
71022910|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-83.33|||||TWO_SIDED|95.0|-450.13|283.46||||||For change in social functioning at EoS, mean change difference was used to compare the two treatment groups.||283.46|-450.13|
70851675|NCT00689117|141191120|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||Inflammatory lesion count|Ranked ANCOVA|||||||0.065
70851676|NCT00689117|141191120|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Inflammatory lesion count|Ranked ANCOVA|||||||0.002
70851677|NCT00689117|141191120|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Inflammatory lesion count|Ranked ANCOVA|||||||<0.001
71022911|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|66.67|||||TWO_SIDED|95.0|-177.86|311.2||||||For change in fatigue at EoS, mean change difference was used to compare the two treatment groups.||311.2|-177.86|
71022912|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.33|||||TWO_SIDED|95.0|-333.46|400.13||||||For change in nausea and vomiting at EoS, mean change difference was used to compare the two treatment groups.||400.13|-333.46|
71022913|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.0|||||TWO_SIDED|95.0|-1258.79|1308.79||||||For change in pain at EoS, mean change difference was used to compare the two treatment groups.||1308.79|-1258.79|
71022914|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|83.33|||||TWO_SIDED|95.0|-283.46|450.13||||||For change in dyspnea at EoS, mean change difference was used to compare the two treatment groups.||450.13|-283.46|
71022915|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.33|||||TWO_SIDED|95.0|-700.26|766.93||||||For change in insomnia at EoS, mean change difference was used to compare the two treatment groups.||766.93|-700.26|
71022916|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.0|||||TWO_SIDED|95.0|-1050.39|1150.39||||||For change in appetite loss at EoS, mean change difference was used to compare the two treatment groups.||1150.39|-1050.39|
71022917|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.67|||||TWO_SIDED|95.0|-1850.65|1817.32||||||For change in constipation at EoS, mean change difference was used to compare the two treatment groups.||1817.32|-1850.65|
71022918|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.33|||||TWO_SIDED|95.0|-700.26|766.93||||||For change in diarrhea at EoS, mean change difference was used to compare the two treatment groups.||766.93|-700.26|
71022919|NCT00219557|141553675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.67|||||TWO_SIDED|95.0|-383.46|350.13||||||For change in financial difficulties at EoS, mean change difference was used to compare the two treatment groups.||350.13|-383.46|
71022920|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.59|||||TWO_SIDED|95.0|-10.11|15.29||||||For change in pancreatic pain at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||15.29|-10.11|
71022921|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.41|||||TWO_SIDED|95.0|-13.39|20.2||||||For change in eating related items at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||20.20|-13.39|
71022922|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.7|||||TWO_SIDED|95.0|5.96|33.43||||||For change in altered bowel habits at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||33.43|5.96|
71022923|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.7|||||TWO_SIDED|95.0|0.93|24.47||||||For change in jaundice at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||24.47|0.93|
71022924|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.1|||||TWO_SIDED|95.0|1.28|28.91||||||For change in body image at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||28.91|1.28|
71022925|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.36|||||TWO_SIDED|95.0|-14.59|23.3||||||For change in health care satisfaction at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||23.30|-14.59|
71022926|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.19|||||TWO_SIDED|95.0|-37.53|-4.85||||||For change in sexual functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||-4.85|-37.53|
71022927|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.82|||||TWO_SIDED|95.0|-25.04|9.4||||||For change in ascites at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||9.40|-25.04|
71022928|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.95|||||TWO_SIDED|95.0|-9.59|21.5||||||For change in indigestion at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||21.50|-9.59|
71022929|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.39|||||TWO_SIDED|95.0|-1.61|30.4||||||For change in flatulence at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||30.40|-1.61|
71022930|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.5|||||TWO_SIDED|95.0|2.78|22.22||||||For change in cachexia at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||22.22|2.78|
71022931|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.88|||||TWO_SIDED|95.0|1.36|20.39||||||For change in side effects at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||20.39|1.36|
71022932|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33|||||TWO_SIDED|95.0|-16.36|11.71||||||For change in fear of future health at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||11.71|-16.36|
71022933|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.21|||||TWO_SIDED|95.0|-11.78|24.2||||||For change in ability to plan future at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||24.20|-11.78|
71022934|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.87|||||TWO_SIDED|95.0|0.79|28.94||||||For change in pancreatic pain at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||28.94|0.79|
71022935|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.49|||||TWO_SIDED|95.0|-7.45|34.42||||||For change in eating related items at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||34.42|-7.45|
71056356|NCT00000620|141616579|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.32|TWO_SIDED|95.0|0.79|1.08||P-value is adjusted for interim monitoring. A priori significance level was 0.05.|Regression, Cox|Adjustment for the seven clinical center networks and presence of clinical cardiovascular disease at baseline as pre-specified in the study protocol.||Recruitment for the Glycemia Trial was designed to enroll 5800 participant to have 87% power to detect a 20% reduction in the rate of MCE for patients in the fenofibrate group as compared with the placebo group, assuming a two-sided alpha level of 0.05, a primary-outcome rate of 2.4% per year in the placebo group, and a planned average follow-up of approximately 5.6 years.||1.08|0.79|0.32
71056357|NCT00000620|141616580|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.3|TWO_SIDED|95.0|0.85|1.05||P-value presented is not adjusted for multiple comparisons. A priori significance level was 0.05.|Regression, Cox|Adjustment for the seven clinical center networks and presence of clinical cardiovascular disease at baseline as pre-specified in the study protocol.||||1.05|0.85|0.30
71056358|NCT02318303|141616585|SUPERIORITY||Mean Difference (Final Values)|-1.1087|||<|0.0001|TWO_SIDED|97.5|-1.669|-0.5485|||ANCOVA|||||-0.5485|-1.6690|<0.0001
71056359|NCT02318303|141616585|SUPERIORITY||Mean Difference (Final Values)|-1.1703|||<|0.0001|TWO_SIDED|97.5|-1.7315|-0.609|||ANCOVA|||||-0.6090|-1.7315|<0.0001
71056360|NCT02318303|141616585|SUPERIORITY||Mean Difference (Final Values)|-0.7718||||0.002|TWO_SIDED|95.0|-1.2616|-0.282|||ANCOVA|||||-0.2820|-1.2616|0.0020
71056361|NCT02318303|141616585|SUPERIORITY||Mean Difference (Final Values)|-0.3563||||0.1524|TWO_SIDED|95.0|-0.8445|0.1319|||ANCOVA|||||0.1319|-0.8445|0.1524
71056362|NCT02318303|141616585|SUPERIORITY||Mean Difference (Final Values)|-0.4918||||0.0488|TWO_SIDED|95.0|-0.981|-0.0025|||ANCOVA|||||-0.0025|-0.9810|0.0488
70851678|NCT00689117|141191120|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Non-inflammatory lesion count|Ranked ANCOVA|||||||<0.001
70851679|NCT00689117|141191120|SUPERIORITY_OR_OTHER|||||||0.284||95.0||||Non-inflammatory lesion count|Ranked ANCOVA|||||||0.284
70851680|NCT00689117|141191120|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Non-inflammatory lesion count|Ranked ANCOVA|||||||<0.001
71056363|NCT02318303|141616585|SUPERIORITY||Mean Difference (Final Values)|-0.7133||||0.0043|TWO_SIDED|95.0|-1.2031|-0.2235|||ANCOVA|||||-0.2235|-1.2031|0.0043
71056364|NCT00314951|141616592|NON_INFERIORITY_OR_EQUIVALENCE|The point estimate of the difference and the 2-sided 95% confidence interval (CI) for the difference between treatment groups were computed. If the lower limit of the CI was greater than -10%, the clinical non-inferiority of fidaxomicin was demonstrated. CIs for the difference of cure rates were calculated using the method recommended by Agresti and Caffo.|Risk Difference (RD)|2.6|||||TWO_SIDED|95.0|-2.9|8.0||||||H0: C(fidaxomicin) - C(Vancomycin) \<= -10% Power calculation is based on cure rate of 85% in both treatment groups, non-inferiority margin of 10%, 2.5% (1-sided) type I error rate with approximately 90% power gives a total of 530 subjects.||8.0|-2.9|
71056365|NCT00314951|141616593|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-9.4||||0.008|TWO_SIDED|95.0|-16.2|-2.5|||Chi-squared|||||-2.5|-16.2|0.008
71056366|NCT00314951|141616594|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.2||||0.007|TWO_SIDED|95.0|2.8|17.5|||Chi-squared|||||17.5|2.8|0.007
71056367|NCT02728843|141616627|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
71056368|NCT02728843|141616628|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
71056369|NCT02728843|141616629|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
71056370|NCT02728843|141616630|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
71056371|NCT02728843|141616631|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
71056372|NCT02728843|141616632|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
71056373|NCT02728843|141616633|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
71056374|NCT04123561|141616698|SUPERIORITY|"The primary efficacy endpoint is defined as the change from Injection 1 Baseline in WOMAC Pain on a normalized scale of 0-4 at Week 12 between the randomized TLC599 12mg and Placebo groups.~The least-squares mean, alongside its corresponding 95% confidence interval, was used to estimate the treatment difference between TLC599 and Placebo, utilizing two-sided p-values."|Least Squares Mean Difference (LSMD)|-0.171|STANDARD_ERROR_OF_MEAN|0.0819||0.0372|TWO_SIDED|95.0|-0.331|-0.01|||ANCOVA|Parameters estimated via REML using the Newton-Raphson algorithm, and the Kenward-Roger method calculates denominator degrees of freedom.||||-0.010|-0.331|0.0372
71077934|NCT02913105|141664399|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.93||||0.2199|TWO_SIDED|90.0|0.85|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 42||1.02|0.85|0.2199
71077935|NCT02913105|141664399|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.4928|TWO_SIDED|90.0|0.87|1.06|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 56||1.06|0.87|0.4928
71107781|NCT04704193|141721261|OTHER|This arm includes descriptive statistics only.|count with proportion|0.931|||||TWO_SIDED|95.0|0.856|0.974||||||"Descriptive statistics only/proportion reported good or excellent~Q1e. There are 3 gene panel options that include either a small, medium, or large number of genes"||.974|.856|
71107782|NCT04704193|141721261|OTHER|This arm includes descriptive statistics only.|count with proportion|0.919|||||TWO_SIDED|95.0|0.839|0.967||||||"Descriptive statistics only/proportion reported good or excellent~Q1f. Gene test results may come back as positive, negative or uncertain"||.967|.839|
71107783|NCT04704193|141721262|OTHER|Summary statistics only|Mean|13.7|STANDARD_DEVIATION|5.6|||TWO_SIDED|||||||||||||
71107784|NCT00542178|141721263|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.003|TWO_SIDED|95.0|0.51|0.87|||Regression, Logistic|Comparisons made using likelihood-ratio tests from logistic-regression models with adjustment for same study-design factors used in ACCORD analysis||Our recruitment goal for the ACCORD Eye study was set in order to achieve a statistical power of 88% to detect a 15% relative reduction with intensive glycemic control as compared with standard glycemic control||0.87|0.51|0.003
70933974|NCT02434328|141368962|OTHER|Treatment difference|Least Squares Mean Difference|-42.6|STANDARD_ERROR_OF_MEAN|9.84|||TWO_SIDED|95.0|-61.9|-23.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88||-23.3|-61.9|
70933975|NCT02434328|141368962|OTHER|Treatment difference|Least Squares Mean Difference|-29.1|STANDARD_ERROR_OF_MEAN|9.56|||TWO_SIDED|95.0|-47.9|-10.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92||-10.3|-47.9|
70933976|NCT02434328|141368962|OTHER|Treatment difference|Least Squares Mean Difference|-42.6|STANDARD_ERROR_OF_MEAN|9.87|||TWO_SIDED|95.0|-62.0|-23.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||-23.3|-62.0|
70933977|NCT02434328|141368963|OTHER|Treatment difference|Least Squares Mean Difference|-36.1|STANDARD_ERROR_OF_MEAN|9.13|||TWO_SIDED|95.0|-54.0|-18.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||-18.1|-54.0|
70933978|NCT02434328|141368964|OTHER|Treatment difference|Least Squares Mean Difference|-36.3|STANDARD_ERROR_OF_MEAN|9.56|||TWO_SIDED|95.0|-55.1|-17.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||-17.6|-55.1|
70933979|NCT02434328|141368965|OTHER|Treatment difference|Least Squares Mean Difference|-30.8|STANDARD_ERROR_OF_MEAN|8.53|||TWO_SIDED|95.0|-47.6|-14.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 48||-14.1|-47.6|
70933980|NCT02434328|141368965|OTHER|Treatment difference|Least Squares Mean Difference|-33.5|STANDARD_ERROR_OF_MEAN|8.84|||TWO_SIDED|95.0|-50.8|-16.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 96||-16.1|-50.8|
71022936|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.86|||||TWO_SIDED|95.0|0.17|37.55||||||For change in altered bowel habits at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||37.55|0.17|
71022937|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.57|||||TWO_SIDED|95.0|0.66|22.48||||||For change in jaundice at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||22.48|0.66|
71022938|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.72|||||TWO_SIDED|95.0|0.49|36.95||||||For change in body image at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||36.95|0.49|
71056375|NCT02089659|141616855|OTHER||Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.72|1.35|||||Moderate hepatic insufficiency / Healthy controls|||1.35|0.72|
71056376|NCT02089659|141616856|OTHER||Geometric Mean Ratio|0.9|||||TWO_SIDED|90.0|0.66|1.24|||||Moderate hepatic insufficiency / Healthy controls|||1.24|0.66|
71056377|NCT02089659|141616857|OTHER||Geometric Mean Ratio|0.93|||||TWO_SIDED|90.0|0.74|1.18|||||Moderate hepatic insufficiency / Healthy controls|||1.18|0.74|
71056378|NCT02089659|141616858|OTHER||Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.74|1.33|||||Moderate hepatic insufficiency / Healthy controls|||1.33|0.74|
71056379|NCT02045147|141616880|OTHER||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|3.82||0.463|TWO_SIDED|95.0|-4.98|10.65|||t-test, 2 sided|||||10.65|-4.98|0.463
71022939|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.61|||||TWO_SIDED|95.0|-32.4|11.17||||||For change in health care satisfaction at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||11.17|-32.40|
71022940|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32|||||TWO_SIDED|95.0|-14.63|17.27||||||For change in sexual functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||17.27|-14.63|
71056380|NCT02045147|141616880|OTHER||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|3.4||0.634|TWO_SIDED|95.0|-5.23|8.49|||t-test, 2 sided|||||8.49|-5.23|0.634
70851681|NCT00689117|141191120|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total lesion count|Ranked ANCOVA|||||||<0.001
70933981|NCT02434328|141368966|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|0.0|0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||0.7|0.0|
71056381|NCT02045147|141616880|OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|4.15||0.259|TWO_SIDED|95.0|-3.74|13.32|||t-test, 2 sided|||||13.32|-3.74|0.259
71056382|NCT02045147|141616880|OTHER||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|2.5||0.472|TWO_SIDED|95.0|-3.21|6.84|||t-test, 2 sided|||||6.84|-3.21|0.472
71056383|NCT02045147|141616881|OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|3.15||0.532|TWO_SIDED|95.0|-8.5|4.5|||t-test, 2 sided|||||4.5|-8.5|0.532
71056384|NCT02045147|141616881|OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|2.9||0.574|TWO_SIDED|95.0|-7.5|4.2|||t-test, 2 sided|||||4.2|-7.5|0.574
71056385|NCT02045147|141616881|OTHER||Mean Difference (Final Values)|-4.5|STANDARD_ERROR_OF_MEAN|3.8||0.254|TWO_SIDED|95.0|-12.3|3.4|||t-test, 2 sided|||||3.4|-12.3|0.254
71056386|NCT02045147|141616881|OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|2.7||0.759|TWO_SIDED|95.0|-6.3|4.6|||t-test, 2 sided|||||4.6|-6.3|0.759
71056387|NCT02045147|141616882|OTHER||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|3.6||0.153|TWO_SIDED|95.0|-2.1|12.7|||t-test, 2 sided|||||12.7|-2.1|0.153
71056388|NCT02045147|141616882|OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|3.3||0.729|TWO_SIDED|95.0|-7.9|5.5|||t-test, 2 sided|||||5.5|-7.9|0.729
71056389|NCT02045147|141616882|OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|3.5||0.886|TWO_SIDED|95.0|-6.6|7.6|||t-test, 2 sided|||||7.6|-6.6|0.886
70851682|NCT00689117|141191120|SUPERIORITY_OR_OTHER|||||||0.028||95.0||||Total lesion count|Ranked ANCOVA|||||||0.028
71056390|NCT02045147|141616882|OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|3.1||0.446|TWO_SIDED|95.0|-8.7|3.9|||t-test, 2 sided|||||3.9|-8.7|0.446
71056391|NCT02045147|141616883|OTHER||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|4.1||0.521|TWO_SIDED|95.0|-5.7|11.1|||t-test, 2 sided|||||11.1|-5.7|0.521
70851683|NCT00689117|141191120|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total lesion count|Ranked ANCOVA|||||||<0.001
70851684|NCT00689117|141191121|SUPERIORITY_OR_OTHER|||||||0.671||95.0|||||Cochran-Mantel-Haenszel|||||||0.671
70851685|NCT00689117|141191121|SUPERIORITY_OR_OTHER|||||||0.919||95.0|||||Cochran-Mantel-Haenszel|||||||0.919
70851686|NCT00689117|141191121|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Cochran-Mantel-Haenszel|||||||0.002
70851687|NCT00689117|141191122|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Cochran-Mantel-Haenszel|||||||0.002
71056392|NCT02045147|141616883|OTHER||Mean Difference (Final Values)|4.2|STANDARD_ERROR_OF_MEAN|2.7||0.146|TWO_SIDED|95.0|-1.5|9.5|||t-test, 2 sided|||||9.5|-1.5|0.146
71056393|NCT02045147|141616883|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|4.3||0.926|TWO_SIDED|95.0|-8.5|9.3|||t-test, 2 sided|||||9.3|-8.5|0.926
71056394|NCT02045147|141616883|OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|2.4||0.526|TWO_SIDED|95.0|-6.4|3.3|||t-test, 2 sided|||||3.3|-6.4|0.526
71056395|NCT02045147|141616884|OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|3.9||0.776|TWO_SIDED|95.0|-9.2|6.9|||t-test, 2 sided|||||6.9|-9.2|0.776
71056396|NCT02045147|141616884|OTHER||Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|3.3||0.135|TWO_SIDED|95.0|-1.6|11.7|||t-test, 2 sided|||||11.7|-1.6|0.135
71056397|NCT02045147|141616884|OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|4.1||0.556|TWO_SIDED|95.0|-10.9|6.0|||t-test, 2 sided|||||6.0|-10.9|0.556
71056398|NCT02045147|141616884|OTHER||Mean Difference (Final Values)|2.5|STANDARD_ERROR_OF_MEAN|2.7||0.361|TWO_SIDED|95.0|-2.9|7.9|||t-test, 2 sided|||||7.9|-2.9|0.361
71056399|NCT02045147|141616885|OTHER||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|4.4||0.564|TWO_SIDED|95.0|-6.4|11.6|||t-test, 2 sided|||||11.6|-6.4|0.564
71056400|NCT02045147|141616885|OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|3.1||0.307|TWO_SIDED|95.0|-3.0|9.3|||t-test, 2 sided|||||9.3|-3.0|0.307
71056401|NCT02045147|141616885|OTHER||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|3.8||0.768|TWO_SIDED|95.0|-6.7|8.9|||t-test, 2 sided|||||8.9|-6.7|0.768
71056402|NCT02045147|141616885|OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|2.4||0.785|TWO_SIDED|95.0|-4.2|5.5|||t-test, 2 sided|||||5.5|-4.2|0.785
71056403|NCT02045147|141616886|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|3.5||0.917|TWO_SIDED|95.0|-7.5|6.8|||t-test, 2 sided|||||6.8|-7.5|0.917
71056404|NCT02045147|141616886|OTHER||Mean Difference (Final Values)|4.6|STANDARD_ERROR_OF_MEAN|3.3||0.181|TWO_SIDED|95.0|-2.2|11.3|||t-test, 2 sided|||||11.3|-2.2|0.181
71056405|NCT02045147|141616886|OTHER||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|3.6||0.772|TWO_SIDED|95.0|-6.3|8.3|||t-test, 2 sided|||||8.3|-6.3|0.772
71056406|NCT02045147|141616886|OTHER||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|2.8||0.526|TWO_SIDED|95.0|-3.8|7.3|||t-test, 2 sided|||||7.3|-3.8|0.526
71056407|NCT02045147|141616887|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.42||0.872|TWO_SIDED|95.0|-0.8|0.9|||t-test, 2 sided|||||.9|-.8|0.872
71056408|NCT02045147|141616887|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.387|TWO_SIDED|95.0|-0.87|0.34|||t-test, 2 sided|||||.34|-.87|0.387
71056409|NCT02045147|141616887|OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.38||0.916|TWO_SIDED|95.0|-0.37|0.81|||t-test, 2 sided|||||.81|-.37|0.916
71056410|NCT02045147|141616887|OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.28||0.189|TWO_SIDED|95.0|-0.19|0.94|||t-test, 2 sided|||||.94|-.19|0.189
71056411|NCT02045147|141616888|OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.627|TWO_SIDED|95.0|-0.21|0.13|||t-test, 2 sided|||||.13|-.21|0.627
71056412|NCT02045147|141616888|OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.84|TWO_SIDED|95.0|-0.11|0.09|||t-test, 2 sided|||||.09|-.11|0.840
71056413|NCT02045147|141616888|OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.05||0.049|TWO_SIDED|95.0|-0.22|0.0|||t-test, 2 sided|||||-.00|-.22|0.049
71056414|NCT02045147|141616888|OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.952|TWO_SIDED|95.0|-0.06|0.06|||t-test, 2 sided|||||.06|-.06|0.952
71056415|NCT02045147|141616889|OTHER||Mean Difference (Final Values)|6.9||||0.436|TWO_SIDED|95.0|-11.07|25.0|||t-test, 2 sided|||||25.00|-11.07|.436
71056416|NCT02045147|141616889|OTHER||Mean Difference (Final Values)|-11.8|STANDARD_ERROR_OF_MEAN|6.71||0.088|TWO_SIDED|95.0|-25.24|1.8|||t-test, 2 sided|||||1.80|-25.24|.088
71056417|NCT02045147|141616889|OTHER||Median Difference (Final Values)|-10.5|STANDARD_ERROR_OF_MEAN|7.45||0.169|TWO_SIDED|95.0|-25.86|4.77|||t-test, 2 sided|||||4.77|-25.86|0.169
71056418|NCT02045147|141616889|OTHER||Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|4.52||0.416|TWO_SIDED|95.0|-12.79|5.37|||t-test, 2 sided|||||5.37|-12.79|0.416
71056419|NCT00264550|141616890|SUPERIORITY_OR_OTHER||||||<|0.001||||||The positive test is defined if the comparison between combined golimumab+MTX and Group 1 is significant at the 0.05, and at least one of the pair-wise comparisons is also significant at the 0.05.|Chi-squared|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups I vs III and Groups I vs IV at 0.05 level of significance. Assuming greater than 90 % power, ACR 20 response for Group I, Group III and Group IV (120, 80, and 80 participants, respectively) as 35 % for Group I and 55 % for Groups III and IV.||||<0.001
71056420|NCT00264550|141616890|SUPERIORITY_OR_OTHER|||||||0.001|||||||Chi-squared|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups I vs III and Groups I vs IV at 0.05 level of significance. Samples of sizes 120, 80, 80 patients in Group I, III, and IV provide \>90% power assuming 35% response in Group I and 55% ACR 20 response in golimumab groups(III \& IV).||||0.001
71056421|NCT00264550|141616890|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups I vs III and Groups I vs IV at 0.05 level of significance. Samples of sizes 120, 80, 80 patients in Group I, III, and IV provide \>90% power assuming 35% response in Group I and 55% ACR 20 response in golimumab groups(III \& IV).||||<0.001
71056422|NCT00264550|141616890|SUPERIORITY_OR_OTHER|||||||0.059||||||This null hypothesis is tested only if a positive test for null hypothesis Statistical Analysis 1.|Chi-squared|||Null hypothesis: No difference between Group II and Group I with respect of ACR 20 at Wk 14. Superiority of golimumab alone vs MTX alone will be demonstrated if 2-sided test is significant. Sample of 120 patients in each Group I \& II provides \>85% power assuming 35% ACR 20 response in Group I and 55% ACR 20 in Group II.||||0.059
71056423|NCT00264550|141616891|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71056424|NCT00264550|141616891|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||||||0.001
71056425|NCT00264550|141616891|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
70851688|NCT00689117|141191122|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
71056426|NCT00264550|141616891|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Chi-squared|||||||0.035
71056427|NCT00264550|141616892|SUPERIORITY_OR_OTHER||||||<|0.001||||||The positive test is defined if the comparison between combined golimumab+MTX and Group I is significant at the 0.05, and at least one of the pair-wise comparisons is also significant at the 0.05.|ANOVA on van der Waerden normal scores.|||Null hypothesis: No difference in HAQ response at Wk 24 comparing Groups I and Combined Golimumab + Methotrexate (MTX) at 0.05 level of significance.||||<0.001
71056428|NCT00264550|141616892|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on van der Waerden normal scores.|||Null hypothesis: No difference in HAQ response at Wk 24 comparing Groups I and III at 0.05 level of significance.||||<0.001
71056429|NCT00264550|141616892|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on van der Waerden normal scores.|||Null hypothesis: No difference in HAQ response at Wk 24 comparing Groups I and IV at 0.05 level of significance.||||<0.001
71056430|NCT00264550|141616892|SUPERIORITY_OR_OTHER|||||||0.24|||||||ANOVA on van der Waerden normal scores.|||Null hypothesis: No difference in HAQ response at Wk 24 comparing Groups I and II at 0.05 level of significance.||||0.240
71056431|NCT00264550|141616893|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71056432|NCT00264550|141616893|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71056433|NCT00264550|141616893|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71056434|NCT00264550|141616893|SUPERIORITY_OR_OTHER|||||||0.187||95.0|||||Chi-squared|||||||0.187
71056435|NCT00264550|141616894|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden noramal|||||||<0.001
71056436|NCT00264550|141616894|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|||||||<0.001
71056437|NCT00264550|141616894|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|||||||<0.001
71056438|NCT00264550|141616894|SUPERIORITY_OR_OTHER|||||||0.097||95.0|||||ANOVA on van der Waerden normal scores|||||||0.097
71056439|NCT00264550|141616895|SUPERIORITY_OR_OTHER|||||||0.551|||||||ANOVA on van der Waerden normal|||||||0.551
71056440|NCT00264550|141616895|SUPERIORITY_OR_OTHER|||||||0.953|||||||ANOVA on van der Waerden normal scores|||||||0.953
71056441|NCT00264550|141616895|SUPERIORITY_OR_OTHER|||||||0.293|||||||ANOVA on van der waerden normal scores|||||||0.293
71056442|NCT00264550|141616895|SUPERIORITY_OR_OTHER|||||||0.361|||||||ANOVA on van der Waerden normal scores|||||||0.361
71056443|NCT00696787|141616915|SUPERIORITY_OR_OTHER||Adjusted mean|-0.38||||0.471|TWO_SIDED|95.0|-1.42|0.66|||ANCOVA|||||0.66|-1.42|0.471
71056444|NCT00696787|141616915|SUPERIORITY_OR_OTHER||Adjusted mean|-0.28||||0.604|TWO_SIDED|95.0|-1.33|0.77|||ANCOVA|||||0.77|-1.33|0.604
71056445|NCT00696787|141616916|SUPERIORITY_OR_OTHER||Adjusted mean|-0.35||||0.51|TWO_SIDED|95.0|-1.42|0.71|||ANCOVA|||||0.71|-1.42|0.510
71056446|NCT00696787|141616916|SUPERIORITY_OR_OTHER||Adjusted mean|-0.55||||0.317|TWO_SIDED|95.0|-1.64|0.54|||ANCOVA|||||0.54|-1.64|0.317
71056447|NCT01549405|141616918|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mann-Whitney U test|||||||0.002
71056448|NCT01549405|141616919|SUPERIORITY_OR_OTHER||Mean Difference (Net)|122.1|STANDARD_DEVIATION|58.0||0|TWO_SIDED|95.0|52.98|132.4|||t-test, 2 sided|||||132.4|52.98|0.000
70933982|NCT02434328|141368966|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-0.1|0.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||0.6|-0.1|
71056449|NCT00603837|141616934|SUPERIORITY_OR_OTHER|||||||0.445||95.0|||||t-test, 1 sided|||||||0.445
71056450|NCT03578549|141616936|OTHER||Correlation Coefficient|0.01||||0.92|TWO_SIDED||||||ANOVA|||||||0.92
71056451|NCT04414345|141616959|SUPERIORITY||Disease Rate Ratio|0.98|STANDARD_DEVIATION|0.1|||TWO_SIDED|95.0|0.797|1.188||Posterior probability that the disease rate ratio (DRR) is less than 1 (i.e. CNM-Au8 slowed progression) was 0.59059. NOTE: p-value is not provided for Bayesian model.|Bayesian shared-parameter model|A Bayesian shared-parameter model of change in disease severity as measured by ALSFRS-R total score and mortality.|"DDR \<1 imply slowing of disease progression by CNM-Au8 relative to placebo. Note: reported Confidence Interval is actually a Bayesian credible interval."||"The DRR parameter for active treatment represents the relative change to the rate of decline of ALSFRS-R and the rate of mortality of treated participant relative to a placebo participant. The estimated DRR can also be interpreted as the average rate of decline in function and mortality.~The model includes covariates for baseline use of edaravone, baseline use of riluzole, months since onset of symptoms, and pre-baseline slope of ALSFRS-R, and random effects for regimen and participant-specific slopes."|1.188|0.797|
71056452|NCT04414345|141616961|SUPERIORITY||Mean Difference (Net)|-0.78|STANDARD_ERROR_OF_MEAN|1.766||0.657|TWO_SIDED|95.0|-4.25|2.68|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|CNM-Au8 24-week change from baseline relative to placebo 24-week change from baseline.|||2.68|-4.25|0.6570
71056453|NCT04414345|141616962|SUPERIORITY||Mean Difference (Net)|-3.1|STANDARD_ERROR_OF_MEAN|3.403||0.3621|TWO_SIDED|95.0|-9.78|3.58|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|CNM-Au8 24-week change from baseline relative to placebo 24-week change from baseline.|||3.58|-9.78|0.3621
71107785|NCT00542178|141721263|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.29|TWO_SIDED|95.0|0.84|1.79|||Regression, Logistic|Comparisons made using likelihood-ratio tests from logistic-regression models with adjustment for same study-design factors used in ACCORD analysis||Our recruitment goal for the ACCORD Eye study was set in order to achieve a statistical power of 80% to detect a 20% relative reduction with intensive blood pressure control as compared with standard blood pressure control||1.79|0.84|0.29
71107786|NCT00542178|141721263|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||0.006|TWO_SIDED|95.0|0.42|0.87|||Regression, Logistic|Comparisons made using likelihood-ratio tests from logistic-regression models with adjustment for same study-design factors used in ACCORD analysis||Our recruitment goal for the ACCORD Eye study was set in order to achieve a statistical power of 91% to detect a 20% relative reduction with lipid control with a statin and fenofibrate as compared with lipid control with a statin alone||0.87|0.42|0.006
71107787|NCT00542178|141721264|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.997||||0.96|TWO_SIDED|95.0|0.901|1.104|||Regression, Cox|||||1.104|0.901|0.96
71107788|NCT00542178|141721264|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.952||||0.5|TWO_SIDED|95.0|0.825|1.099|||Regression, Cox|||||1.099|0.825|0.50
71056454|NCT04414345|141616963|SUPERIORITY|||||||0.7398|||||||Log Rank|||||||0.7398
71056455|NCT02052011|141616969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27|||||TWO_SIDED|95.0|-0.08|0.62||||||||0.62|-0.08|
71056456|NCT01851330|141616970|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF 8 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
71056457|NCT01851330|141616970|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF+RBV 8 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
71056458|NCT01851330|141616970|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF 12 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
71056459|NCT01851330|141616970|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority would be demonstrated if the lower bound of the confidence interval (CI) for the difference between groups was greater than -12%.|Difference in proportions|-3.2|||||TWO_SIDED|97.5|-8.3|1.8|||||Difference in proportions between treatment groups and associated confidence interval (CI) were calculated based on stratum-adjusted Mantel-Haenszel proportions.|||1.8|-8.3|
71107789|NCT00542178|141721264|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.08|TWO_SIDED|95.0|0.762|1.016|||Regression, Cox|||||1.016|0.762|0.08
71107790|NCT00542178|141721265|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.884||||0.0355|TWO_SIDED|95.0|0.788|0.992|||Regression, Cox|||||0.992|0.788|0.0355
71107791|NCT00542178|141721265|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.891||||0.17|TWO_SIDED|95.0|0.755|1.051|||Regression, Cox|||||1.051|0.755|0.17
70851689|NCT00689117|141191122|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
71022941|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.54|||||TWO_SIDED|95.0|-14.7|17.78||||||For change in ascites at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||17.78|-14.70|
71022942|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.05|||||TWO_SIDED|95.0|-10.65|32.75||||||For change in indigestion at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||32.75|-10.65|
71022943|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4|||||TWO_SIDED|95.0|-17.33|24.13||||||For change in flatulence at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||24.13|-17.33|
71056460|NCT01851330|141616970|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority would be demonstrated if the lower bound of the CI for the difference between groups was greater than -12%.|Difference in proportions|-2.3|||||TWO_SIDED|97.5|-7.2|2.5|||||Difference in proportions between treatment groups and associated confidence interval (CI) were calculated based on stratum-adjusted Mantel-Haenszel proportions.|||2.5|-7.2|
70851690|NCT01086358|141191130|SUPERIORITY||Mean Difference (Final Values)|-1.71||||0.007|TWO_SIDED|95.0|-2.92|-0.49|||Mixed Models Analysis|As noted above, results are adjusted for study period and treatment order||Analysis is a superiority comparison based on the use of linear mixed effect model with subject as a random effect, with treatment as the primary fixed effect and including study period and treatment order as other fixed effects.||-0.49|-2.92|0.007
70851691|NCT01086358|141191131|SUPERIORITY||Mean Difference (Final Values)|-1.03||||0.01|TWO_SIDED|95.0|-1.79|-0.27|||Mixed Models Analysis|As noted above, results are adjusted for study period and treatment order||Analysis is a superiority comparison based on the use of linear mixed effect model with subject as a random effect, with treatment as the primary fixed effect and including study period and treatment order as other fixed effects.||-0.27|-1.79|0.010
70851692|NCT01086358|141191132|SUPERIORITY||Mean Difference (Final Values)|-0.68||||0.059|TWO_SIDED|95.0|-1.39|0.03|||Mixed Models Analysis|As noted above, results are adjusted for study period and treatment order.||Analysis is a superiority comparison based on the use of linear mixed effect model with subject as a random effect, with treatment as the primary fixed effect and including study period and treatment order as other fixed effects.||0.03|-1.39|0.059
70851693|NCT01086358|141191133|SUPERIORITY||Odds Ratio (OR)|2.89||||0.016|TWO_SIDED|95.0|1.22|6.84|||Regression, Logistic|As noted above, results are adjusted for study period and treatment order.||Logistic regression models with generalized estimating equations were used. In these models, a logit link function was used for a favorable response (yes/no) with treatment as the primary fixed effect and including study period and treatment order as other fixed effects..||6.84|1.22|0.016
70851694|NCT04975230|141191134|OTHER||Cohen's D|0.17|STANDARD_ERROR_OF_MEAN|0.17||0.0227|TWO_SIDED|95.0|-0.37|0.78|||Mixed Models Analysis|||||0.78|-0.37|0.0227
70851695|NCT02471612|141191158|SUPERIORITY_OR_OTHER_LEGACY|||||||0.665||||||Comparing the sensitivity of APACHE-II and P-POSSUM|McNemar|||"Area under the curve (AUC) is used to measure the size of the prediction composed by the graphic display between the 'sensitivity' and the '1-specificity' relationship. AUC can range from 0.5 to 1.0 and a result of 1.0 indicates a perfect discriminatory ability. An AUC value \> 0.8 is considered good, a range between 0.60-0.80 is considered as moderate, and an AUC value \< 0.60 is regarded as poor."||||0.665
70851696|NCT03116152|141191254|SUPERIORITY||Hazard Ratio (HR)|0.701||||0.032|TWO_SIDED|95.0|0.504|0.972|||Log Rank|||||0.972|0.504|0.032
70851697|NCT03116152|141191255|SUPERIORITY||Hazard Ratio (HR)|1.002||||0.979|TWO_SIDED|95.0|0.722|1.391|||Log Rank|||||1.391|0.722|0.979
70851698|NCT03116152|141191256|SUPERIORITY||Difference in Percentages|6.3|||||TWO_SIDED|95.0|-2.2|15.4||||||||15.4|-2.2|
70851699|NCT03116152|141191257|SUPERIORITY|||||||0.345|||||||Log Rank|||||||0.345
71056461|NCT01851330|141616970|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority would be demonstrated if the lower bound of the CI for the difference between groups was greater than -12%.|Difference in proportions|0.9|||||TWO_SIDED|95.0|-3.9|5.7|||||Difference in proportions between treatment groups and associated confidence interval (CI) were calculated based on stratum-adjusted Mantel-Haenszel proportions.|||5.7|-3.9|
71056462|NCT02960490|141616984|SUPERIORITY||Difference from Placebo|-4.7||||0.621|TWO_SIDED|95.0|-25.85|16.46|||Regression, Logistic|||||16.46|-25.85|0.621
71056463|NCT02667067|141617005|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<.001
71056464|NCT02368314|141617021|SUPERIORITY_OR_OTHER|||||||0.226|||||||Fisher Exact|||||||0.226
71056465|NCT01333397|141617040|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||ILA - Dysport NG 20 U Vs Placebo||||<0.0001
70851700|NCT02448641|141191267|SUPERIORITY||Odds Ratio (OR)|1.33||||0.6743|TWO_SIDED|95.0|0.35|5.09||GLMM: Generalized Linear Mixed Model|Mixed Models Analysis|A GLMM with FMMS responder as outcome, treatment, visit, treatment-visit interaction, pooled site, Baseline FMMS and Baseline mRS scores as covariates||Combined SB623 Implant Vs Sham Surgery group at Month 6||5.09|0.35|0.6743
70851701|NCT02448641|141191268|SUPERIORITY||Odds Ratio (OR)|0.43||||0.1|TWO_SIDED|95.0|0.15|1.18||GLMM: Generalized Linear Mixed Model|Mixed Models Analysis|A GLMM with mRS responder as outcome, treatment, visit, treatment-visit interaction, pooled site and Baseline mRS scores as covariates||Combined SB623 Implant Vs Sham Surgery group at Month 6||1.18|0.15|0.1000
70851702|NCT02448641|141191271|SUPERIORITY||Mean Difference (Net)|-0.36||||0.7788|TWO_SIDED|95.0|-2.9|2.17||Combined SB623 vs. Sham at month 6 MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|MMRM included treatment, visit, pooled site, corresponding Baseline sub-domain T-score, Baseline mRS score, and the treatment-by-visit interaction|LSMD (Least square mean difference) (SE): -0.36 (1.283)|Statistical analysis: NeuroQOL score for the Upper Extremity Function (Represents Mean Change from Baseline in T-Scores at Month 6)||2.17|-2.90|0.7788
70933983|NCT02434328|141368966|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|0.0|0.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||0.6|0.0|
71022944|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.27|||||TWO_SIDED|95.0|-4.4|22.93||||||For change in cachexia at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||22.93|-4.40|
71022945|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.19|||||TWO_SIDED|95.0|2.99|35.39||||||For change in side effects at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||35.39|2.99|
70933984|NCT02434328|141368967|OTHER|Treatment difference|Least Squares Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|4.8|||TWO_SIDED|95.0|-11.6|7.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4||7.3|-11.6|
71107792|NCT00542178|141721265|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.015||||0.86|TWO_SIDED|95.0|0.865|1.19|||Regression, Cox|||||1.190|0.865|0.86
71107793|NCT00542178|141721266|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.069|TWO_SIDED|95.0|0.71|1.69|||Regression, Logistic|||||1.69|0.71|0.069
71107794|NCT00542178|141721266|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.63|TWO_SIDED|95.0|0.44|1.63|||Regression, Logistic|||||1.63|0.44|0.63
71107795|NCT00542178|141721266|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.78|TWO_SIDED|95.0|0.6|1.96|||Regression, Logistic|||||1.96|0.60|0.78
70933985|NCT02434328|141368967|OTHER|Treatment difference|Least Squares Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|4.98|||TWO_SIDED|95.0|-13.6|6.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8||6.0|-13.6|
71022946|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63|||||TWO_SIDED|95.0|-23.7|22.43||||||For change in fear of future health at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||22.43|-23.70|
71022947|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.51|||||TWO_SIDED|95.0|-3.1|46.12||||||For change in ability to plan future at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||46.12|-3.10|
71022948|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.19|||||TWO_SIDED|95.0|-21.57|13.19||||||For change in pancreatic pain at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||13.19|-21.57|
71022949|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.6|||||TWO_SIDED|95.0|-32.86|7.66||||||For change in eating related items at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||7.66|-32.86|
71022950|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.25|||||TWO_SIDED|95.0|-10.33|34.82||||||For change in altered bowel habits at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||34.82|-10.33|
71022951|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.84|||||TWO_SIDED|95.0|-0.18|25.85||||||For change in jaundice at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||25.85|-0.18|
71022952|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.85|||||TWO_SIDED|95.0|-16.45|24.14||||||For change in body image at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||24.14|-16.45|
71022953|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.05|||||TWO_SIDED|95.0|-23.23|37.34||||||For change in health care satisfaction at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||37.34|-23.23|
71022954|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.53|||||TWO_SIDED|95.0|-26.55|21.5||||||For change in sexual functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||21.50|-26.55|
71022955|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.46|||||TWO_SIDED|95.0|-27.48|8.56||||||For change in ascites at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||8.56|-27.48|
71022956|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.96|||||TWO_SIDED|95.0|-30.62|16.7||||||For change in indigestion at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||16.70|-30.62|
71022957|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.71|||||TWO_SIDED|95.0|-20.37|27.8||||||For change in flatulence at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||27.80|-20.37|
71022958|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.04|||||TWO_SIDED|95.0|-5.73|31.81||||||For change in cachexia at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||31.81|-5.73|
71022959|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.12|||||TWO_SIDED|95.0|-3.23|33.46||||||For change in side effects at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||33.46|-3.23|
71022960|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.91|||||TWO_SIDED|95.0|-36.18|20.37||||||For change in fear of future health at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||20.37|-36.18|
71022961|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.38|||||TWO_SIDED|95.0|-20.24|51.01||||||For change in ability to plan future at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||51.01|-20.24|
71022962|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.25|||||TWO_SIDED|95.0|-10.09|32.59||||||For change in pancreatic pain at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||32.59|-10.09|
71022963|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.41|||||TWO_SIDED|95.0|-25.22|40.03||||||For change in eating related items at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||40.03|-25.22|
71022964|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.28|||||TWO_SIDED|95.0|4.23|52.32||||||For change in altered bowel habits at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||52.32|4.23|
71022965|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.22|||||TWO_SIDED|95.0|5.09|43.34||||||For change in jaundice at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||43.34|5.09|
71022966|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.11|||||TWO_SIDED|95.0|-0.16|50.38||||||For change in body image at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||50.38|-0.16|
71022967|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.07|||||TWO_SIDED|95.0|-47.95|27.8||||||For change in health care satisfaction at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||27.80|-47.95|
71022968|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.61|||||TWO_SIDED|95.0|-21.78|14.57||||||For change in sexual functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||14.57|-21.78|
70933986|NCT02434328|141368967|OTHER|Treatment difference|Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|4.98|||TWO_SIDED|95.0|-14.3|5.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||5.3|-14.3|
70933987|NCT02434328|141368967|OTHER|Treatment difference|Least Squares Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|5.12|||TWO_SIDED|95.0|-13.7|6.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16||6.4|-13.7|
70933988|NCT02434328|141368967|OTHER|Treatment difference|Least Squares Mean Difference|4.6|STANDARD_ERROR_OF_MEAN|5.11|||TWO_SIDED|95.0|-5.5|14.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20||14.6|-5.5|
70933989|NCT02434328|141368967|OTHER|Treatment difference|Least Squares Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|5.35|||TWO_SIDED|95.0|-16.3|4.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||4.7|-16.3|
71022969|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.98|||||TWO_SIDED|95.0|-17.02|28.99||||||For change in ascites at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||28.99|-17.02|
71022970|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.08|||||TWO_SIDED|95.0|-5.39|49.55||||||For change in indigestion at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||49.55|-5.39|
71022971|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.78|||||TWO_SIDED|95.0|-15.33|34.89||||||For change in flatulence at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||34.89|-15.33|
71022972|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.81|||||TWO_SIDED|95.0|-10.43|42.06||||||For change in cachexia at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||42.06|-10.43|
71022973|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.77|||||TWO_SIDED|95.0|1.11|42.43||||||For change in side effects at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||42.43|1.11|
71022974|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.81|||||TWO_SIDED|95.0|-41.91|12.28||||||For change in fear of future health at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||12.28|-41.91|
71022975|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.11|||||TWO_SIDED|95.0|1.6|60.62||||||For change in ability to plan future at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||60.62|1.60|
71022976|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.74|||||TWO_SIDED|95.0|-20.62|38.1||||||For change in pancreatic pain at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||38.10|-20.62|
71056466|NCT01333397|141617040|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||ILA - Dysport NG 50 U Vs Placebo||||<0.0001
70933990|NCT02434328|141368967|OTHER|Treatment difference|Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|5.13|||TWO_SIDED|95.0|-13.1|7.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28||7.0|-13.1|
71022977|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.24|||||TWO_SIDED|95.0|-68.52|42.05||||||For change in eating related items at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||42.05|-68.52|
71022978|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.06|||||TWO_SIDED|95.0|-7.93|52.05||||||For change in altered bowel habits at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||52.05|-7.93|
71022979|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.63|||||TWO_SIDED|95.0|-5.64|42.89||||||For change in jaundice at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||42.89|-5.64|
71056467|NCT01333397|141617040|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||ILA - Dysport NG 75 U Vs Placebo||||<0.0001
71022980|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.96|||||TWO_SIDED|95.0|-9.93|57.84||||||For change in body image at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||57.84|-9.93|
71022981|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.54|||||TWO_SIDED|95.0|-32.7|59.78||||||For change in health care satisfaction at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||59.78|-32.70|
71022982|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.14|||||TWO_SIDED|95.0|-29.46|55.74||||||For change in sexual functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||55.74|-29.46|
71022983|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.37|||||TWO_SIDED|95.0|-24.04|36.79||||||For change in ascites at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||36.79|-24.04|
71022984|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.59|||||TWO_SIDED|95.0|-17.94|59.12||||||For change in indigestion at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||59.12|-17.94|
71022985|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.29|||||TWO_SIDED|95.0|-20.12|40.71||||||For change in flatulence at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||40.71|-20.12|
71056468|NCT01333397|141617040|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||SSA - Dysport NG 20 U Vs Placebo||||<0.0001
71056469|NCT01333397|141617040|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||SSA - Dysport NG 50 U Vs Placebo||||<0.0001
71056470|NCT01333397|141617040|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||SSA - Dysport NG 75 U Vs Placebo||||<0.0001
71056471|NCT04411914|141617105|SUPERIORITY|||||||0.0009|||||||Spearman Correlation Coefficient|||||||0.0009
71056472|NCT04411914|141617106|OTHER|||||||0.0053|||||||Spearman Correlation Coefficient|"Spearman Correlation Coefficient, N=9 Prob \> \|r\| under H0: Rho=0"||||||0.0053
71107796|NCT03449576|141721267|SUPERIORITY||Slope|5.3846|STANDARD_ERROR_OF_MEAN|6.5525||0.4154|TWO_SIDED|||||This P value is the interaction term between Visit and Treatment.|Regression, Linear||This is the beta value for the interaction term between Visit and Treatment.|Test of prediction of dependent variable -- the CAPS score-- with the interaction between Visit (pre/post) and treatment type (TMT vs. EXP+EDU), as well as independent variable, age||||0.4154
71107797|NCT03449576|141721268|SUPERIORITY||Slope|0.267397|STANDARD_ERROR_OF_MEAN|0.362521||0.4636|TWO_SIDED|||||This P value is the interaction term between Visit and Treatment.|Regression, Linear||This is the beta value for the interaction term between Visit and Treatment.|Test of prediction of dependent variable -- the SAS-SR score-- with the interaction between Visit (pre/post) and Treatment type (TMT vs. EXP+EDU), as well as independent variable, age||||0.4636
71107798|NCT03449576|141721269|SUPERIORITY||Slope|2.3355|STANDARD_ERROR_OF_MEAN|6.8791||0.735129|TWO_SIDED|||||This P value is the interaction term between Visit and Treatment.|Regression, Linear||This is the beta value for the interaction term between Visit and Treatment.|Test of prediction of dependent variable -- the PCL score-- with the interaction between Visit (pre/post) and treatment type (TMT vs. EXP+EDU), as well as independent variable, age||||0.735129
71107799|NCT03449576|141721270|SUPERIORITY||Slope|-2.64908|STANDARD_ERROR_OF_MEAN|4.76601||0.58|TWO_SIDED|||||This P value is the interaction term between Visit and Treatment.|Regression, Linear||This is the beta value for the interaction term between Visit and Treatment.|Test of prediction of dependent variable -- the AQ score-- with the interaction between Visit (pre/post) and treatment type (TMT vs. EXP+EDU), as well as independent variable, age||||0.580
71107800|NCT03449576|141721271|SUPERIORITY||Slope|1.3946|STANDARD_ERROR_OF_MEAN|5.7193||0.808|TWO_SIDED|||||This P value is the interaction term between Visit and Treatment.|Regression, Linear||This is the beta value for the interaction term between Visit and Treatment.|Test of prediction of dependent variable -- the ITS score-- with the interaction between Visit (pre/post) and treatment type (TMT vs. EXP+EDU), as well as independent variable, age||||0.808
71107801|NCT02777086|141721288|SUPERIORITY||||||<|0.001|||||||ANCOVA|||3-month outcome measures were compared between the StaySafe and Comparison groups controlling for the baseline measure using generalized linear models.||||<.001
71107802|NCT02122380|141721334|SUPERIORITY|||||||0.918|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of mean growth hormone (GH) levels between sitagliptin and placebo. The test was performed with a significance level of 0.05 (two sided). A sample size of 16 participants was needed to provide 93% power to detect a difference in GH means of 0.5 mcg/L.||||0.918
71107803|NCT02122380|141721335|SUPERIORITY|||||||0.054|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of early insulin secretion between sitagliptin and placebo. The test was performed with a significance level of 0.05 (two sided).||||0.054
71107804|NCT02122380|141721336|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in blood glucose levels between sitagliptin and placebo. The test was performed with a significance level of 0.05 (two sided).||||0.009
71107805|NCT02122380|141721337|SUPERIORITY|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in the mass of visceral adipose tissue after sitagliptin vs. placebo. The test was performed with a significance level of 0.05 (two sided).||||0.022
71107806|NCT02122380|141721338|SUPERIORITY|||||||0.943|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in vascular function between sitagliptin and placebo treatments. The test was performed with a significance level of 0.05 (two sided).||||0.943
71107807|NCT00272792|141721339|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 1 sided|||Compared Week 10 to Baseline.||||<0.001
71107808|NCT00272792|141721339|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||t-test, 1 sided|||Compared Week 10 to Baseline.||||0.027
70933991|NCT02434328|141368967|OTHER|Treatment difference|Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|5.37|||TWO_SIDED|95.0|-12.6|8.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32||8.5|-12.6|
70933992|NCT02434328|141368967|OTHER|Treatment difference|Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|5.15|||TWO_SIDED|95.0|-15.2|5.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36||5.1|-15.2|
70933993|NCT02434328|141368967|OTHER|Treatment difference|Least Squares Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|-17.0|3.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40||3.8|-17.0|
70933994|NCT02434328|141368967|OTHER|Treatment difference|Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|5.42|||TWO_SIDED|95.0|-13.4|7.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44||7.9|-13.4|
70933995|NCT02434328|141368967|OTHER|Treatment difference|Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.0|-17.6|3.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||3.7|-17.6|
70933996|NCT02434328|141368967|OTHER|Treatment difference|Least Squares Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|5.19|||TWO_SIDED|95.0|-12.9|7.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52||7.5|-12.9|
70933997|NCT02434328|141368967|OTHER|Treatment difference|Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|5.31|||TWO_SIDED|95.0|-15.4|5.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56||5.4|-15.4|
70933998|NCT02434328|141368967|OTHER|Treatment difference|Least Squares Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|5.15|||TWO_SIDED|95.0|-14.3|5.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60||5.9|-14.3|
70933999|NCT02434328|141368967|OTHER|Treatment difference|Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|5.24|||TWO_SIDED|95.0|-14.2|6.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64||6.4|-14.2|
70934000|NCT02434328|141368967|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|5.17|||TWO_SIDED|95.0|-10.7|9.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68||9.6|-10.7|
70934001|NCT02434328|141368967|OTHER|Treatment difference|Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|5.24|||TWO_SIDED|95.0|-14.8|5.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||5.7|-14.8|
70934002|NCT02434328|141368967|OTHER|Treatment difference|Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|5.23|||TWO_SIDED|95.0|-13.1|7.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76||7.4|-13.1|
70934003|NCT02434328|141368967|OTHER|Treatment difference|Least Squares Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|5.33|||TWO_SIDED|95.0|-14.1|6.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80||6.8|-14.1|
71056473|NCT01778634|141617110|SUPERIORITY||Odds Ratio (OR)|7.51|||<|0.0001|TWO_SIDED|95.0|2.53|22.27|||Cochran-Mantel-Haenszel|||||22.27|2.53|<0.0001
71056474|NCT01778634|141617111|SUPERIORITY||Risk Difference (RD)|0.11||||0.28|TWO_SIDED|95.0|-0.08|0.29|||Generalized Estimating Equations||Generalized Estimating Equations with an identity link|||0.29|-0.08|0.28
71022986|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.74|||||TWO_SIDED|95.0|-8.22|59.69||||||For change in cachexia at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||59.69|-8.22|
71022987|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.56|||||TWO_SIDED|95.0|5.32|71.81||||||For change in side effects at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||71.81|5.32|
71056475|NCT01778634|141617112|SUPERIORITY|P values are based on GEE to account for twins||||||0.11|||||||GEE|||||||0.11
71056476|NCT01778634|141617113|SUPERIORITY|P values are based on GEE to account for twins. The counts provided refer to to the numbers actually observed. The analysis to determine the p value accounted for the missing 11 patients using multiple imputation.||||||0.62|||||||GEE with multiple imputation|||||||0.62
71022988|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.44|||||TWO_SIDED|95.0|-53.14|44.25||||||For change in fear of future health at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||44.25|-53.14|
71022989|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.17|||||TWO_SIDED|95.0|-69.9|61.57||||||For change in ability to plan future at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||61.57|-69.90|
71056477|NCT01778634|141617114|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
70934004|NCT02434328|141368967|OTHER|Treatment difference|Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|-13.5|7.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84||7.3|-13.5|
71056478|NCT01778634|141617115|SUPERIORITY|||||||0.88||||||To include non-survivors as bad values of this outcome we imputed a high value for the participants who died. Note, because we analyzed the data using a nonparametric test, the actual value doesn't affect the analysis, only the rank of the value.|Wilcoxon (Mann-Whitney)|||||||0.88
71056479|NCT01778634|141617116|SUPERIORITY||Median Difference (Final Values)|5.0||||0.94|TWO_SIDED|95.0|-15.0|26.0||To include non-survivors as bad values of this outcome we imputed a high value for the participants who died. Note, because we analyzed the data using a nonparametric test, the actual value doesn't affect the analysis, only the rank of the value.|Wilcoxon test after multiple outputation||Bootstrap|||26|-15|0.94
71056480|NCT01778634|141617117|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
71107809|NCT00272792|141721340|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Longitudinal Model|Longitudinal model with blood Phe measurements as the response variable and treatment group, visit, and baseline blood Phe level as covariates.||||||0.009
71107810|NCT02921789|141721341|SUPERIORITY||Difference|-12.7||||0.3705|TWO_SIDED|95.0|-34.5|9.0||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||||9.0|-34.5|0.3705
71107811|NCT02921789|141721342|SUPERIORITY||Difference|-12.7||||0.3705|TWO_SIDED|95.0|-34.5|9.0||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 6||9.0|-34.5|0.3705
71107812|NCT02921789|141721342|SUPERIORITY||Difference|-12.4||||0.389|TWO_SIDED|95.0|-35.8|11.0||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 12||11.0|-35.8|0.3890
71107813|NCT02921789|141721343|SUPERIORITY||Difference|6.9||||0.752|TWO_SIDED|95.0|-15.3|29.2||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 3||29.2|-15.3|0.7520
71107814|NCT02921789|141721343|SUPERIORITY||Difference|6.9||||0.752||95.0|-15.3|29.2||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 6||29.2|-15.3|0.7520
71107815|NCT02921789|141721343|SUPERIORITY||Difference|5.0||||0.7597|TWO_SIDED|95.0|-18.9|29.0||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 12||29.0|-18.9|0.7597
71107816|NCT02921789|141721344|SUPERIORITY||Difference|-0.3||||1||95.0|-24.9|24.3||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||||24.3|-24.9|1.0
71056481|NCT01778634|141617118|SUPERIORITY||Odds Ratio (OR)|1.07||||0.88|TWO_SIDED|95.0|0.44|2.63|||Cochran-Mantel-Haenszel|||||2.63|0.44|0.88
71056482|NCT01778634|141617119|SUPERIORITY|||||||0.18|||||||Generalized Estimating Equations|||||||0.18
71056483|NCT01778634|141617121|SUPERIORITY|||||||0.05|||||||Generalized Estimating Equation|||||||0.05
71056484|NCT01778634|141617122|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71056485|NCT01778634|141617123|SUPERIORITY|||||||0.18|||||||Generalized Estimating Equations|||||||0.18
71056486|NCT01778634|141617124|SUPERIORITY|||||||0.091|||||||Fisher Exact|||||||0.091
71056487|NCT01778634|141617125|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71056488|NCT01778634|141617126|SUPERIORITY|||||||0.33|||||||Generalized Estimating Equations|||||||0.33
71056489|NCT01778634|141617127|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71107817|NCT02921789|141721345|SUPERIORITY||Difference|-3.9||||1||95.0|-30.2|22.4||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 3||22.4|-30.2|1.0
71107818|NCT02921789|141721345|SUPERIORITY||Difference|-6.2||||0.772||95.0|-31.7|19.3||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 6||19.3|-31.7|0.7720
71107819|NCT02921789|141721345|SUPERIORITY||Difference|-7.5||||0.772||95.0|-32.6|17.6||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 12||17.6|-32.6|0.7720
71107820|NCT01766102|141721354|OTHER|||||||0.716|||||||t-test, 2 sided|||H0: Procedure time is not significantly different based on mammography type used||||0.716
71107821|NCT01766102|141721354|OTHER|||||||0.676|||||||t-test, 2 sided|||H0: Operating room time is not significantly different based on mammography type used||||0.676
71107822|NCT03423602|141721358|NON_INFERIORITY|Based on a Meta-Analysis of a focused systematic literature review from a comparable patient population, the estimated major vascular access site complication rate or PGsafety for the conservative Random Effect Model is 0.125 with a 95% Confidence Interval of 0.09 to 0.17. Given that the upper bound was 0.17 this justified the use of 0.13 as a valid PGsafety plus a non-inferiority margin of 0.04 yielding an overall non-inferiority limit (NLs) of 0.17 for Safety. Study power is greater than 90%|Wilson's exact test|0.0487|||<|0.0001|ONE_SIDED|95.0||0.0487|||Wilson's exact test|All 75 enrolled subjects, regardless of their enrolment status at 1-month post implantation, including all reported safety data where included.||"The test for non-inferiority for safety was based on a one-sided test (at the 0.025 significance level) for a binomial proportion with hypotheses:~H0s: Psafety ≥ NLs versus H1s: Psafety \< NLs Where: Psafety is the actual proportion of device related major vascular access site complications within the study population; and NLs is the non-inferiority limit for proportion of expected major vascular access site complications associated with cut-down and suture closure."||0.0487||<.0001
71117625|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
71107823|NCT04790786|141721408|EQUIVALENCE|Equivalence between two arms was defined as 95% posterior probability the odds ratio is within a given bound.||||||||||||Equivalence between two arms was defined as 95% posterior probability the odds ratio is within a given bound based on Bayesian probability.|Bayesian cumulative logistic model|Bayesian cumulative logistic model, Equivalence between two arms was defined as 95% posterior probability the odds ratio is within a given bound.||The primary analysis model was a Bayesian cumulative logistic model that adjusted for treatment location (infusion center or ED), age (\<30, 30-39, 40-49, 50-59, 60-69, 70-79, and ≥ 80 years), sex, and time (2-week epochs). Comparisons between individual mAb were based on the relative odds ratio between a given two arms for the primary outcome. An odds ratio for an arm to a comparator \>1 implies improved outcomes. A sliding scale with different levels of equivalence bounds was pre-defined|Equivalence between two arms was defined as 95% posterior probability the odds ratio is within a given bound.|||
71107824|NCT01493089|141721428|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.097||||0.563||95.0|||||Regression, Cox|||||||0.563
71056490|NCT00863772|141617180|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.37||0.434|TWO_SIDED|95.0|-0.44|1.01|||ANCOVA|||Analysis of co-variance (ANCOVA) model was used with treatment as main effect, baseline value as a covariate, and study site as a random effect.||1.01|-0.44|0.434
71056491|NCT00863772|141617180|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.37||0.883|TWO_SIDED|95.0|-0.68|0.79|||ANCOVA|||ANCOVA model was used with treatment as main effect, baseline value as a covariate, and study site as a random effect.||0.79|-0.68|0.883
71056492|NCT00863772|141617181|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.37||0.72|TWO_SIDED|95.0|-0.59|0.86|||ANCOVA|||Analysis of co-variance (ANCOVA) model was used with treatment as main effect, baseline value as a covariate, and study site as a random effect.||0.86|-0.59|0.720
71056493|NCT00863772|141617181|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.37||0.985|TWO_SIDED|95.0|-0.73|0.74|||ANCOVA|||ANCOVA model was used with treatment as main effect, baseline value as a covariate, and study site as a random effect.||0.74|-0.73|0.985
71056494|NCT01307748|141617264|OTHER|||||||0.005||||||The p value was adjusted for multiple comparisons using false discovery rate.|ANCOVA|Repeated-measures ANOVA with time (stress, post-stress) as a within factor and aroma (lavender, coconut, water) as a between-group factor was used.||The null hypothesis stated that there were no differences between the groups in cortisol level trajectory over time.||||.005
71056495|NCT01307748|141617266|OTHER|||||||0.01||||||P value was adjusted for multiple comparisons using false discovery rate|ANCOVA|A 3 (lavender, coconut, water) by 2 ( prime, no prime) Analysis of Covariance (ANCOVA), with years of education as a covariate was used.||||||.01
71056496|NCT00351533|141617275|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.37
71056497|NCT00351533|141617276|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.04
71056498|NCT00351533|141617277|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.16
71056499|NCT00351533|141617278|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.79
71056500|NCT00351533|141617279|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.34
71056501|NCT00351533|141617280|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||t-test, 2 sided|||||||0.26
71056502|NCT00351533|141617281|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||t-test, 2 sided|||||||0.06
71056503|NCT00351533|141617282|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.89
71056504|NCT00351533|141617283|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
71056505|NCT00351533|141617284|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.27
71056506|NCT00351533|141617285|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.20
71056507|NCT00351533|141617286|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.11
71107825|NCT01493089|141721429|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.903||||0.712||95.0|||||Regression, Cox|||||||0.712
71056508|NCT00351533|141617287|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||t-test, 2 sided|||||||0.56
71056509|NCT00351533|141617288|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||t-test, 2 sided|||||||0.69
71056510|NCT00351533|141617289|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||t-test, 2 sided|||||||0.66
71056511|NCT00351533|141617290|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||t-test, 2 sided|||||||0.27
71056512|NCT00351533|141617291|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Chi-squared|||||||0.65
71056513|NCT00351533|141617292|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||Chi-squared|||||||0.49
71056514|NCT00351533|141617293|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.55
71056515|NCT00351533|141617294|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.38
71056516|NCT00351533|141617295|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.84
71056517|NCT00351533|141617296|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.74
71056518|NCT00351533|141617297|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.84
71056519|NCT00351533|141617298|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.71
71056520|NCT00351533|141617299|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.08
71056521|NCT00351533|141617300|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.86
71056522|NCT00351533|141617301|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.89
71056523|NCT00351533|141617302|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.34
71056524|NCT00315731|141617308|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of AUC values after dosimetric dose of fission-derived 131I-tositumomab with historical data from tellurium-derived 131I-tositumomab|Ratio of AUC(0-120)|0.97|||||TWO_SIDED|90.0|0.85|1.12|||||Ratio of AUC(0-120) is the ratio of AUC(0-120) values following infusion of fission-derived 131I-tositumomab to those following infusion of tellurium-derived 131I-tositumomab.|||1.12|0.85|
71107826|NCT01493089|141721430|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.457|TWO_SIDED|95.0|||||Regression, Cox|||||||0.457
71107827|NCT01493089|141721431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8||||0.625||95.0|-9.7|15.3|||Regression, Cox|||Sustained partial response||15.3|-9.7|0.625
70934005|NCT02434328|141368967|OTHER|Treatment difference|Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|5.39|||TWO_SIDED|95.0|-14.6|6.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88||6.5|-14.6|
70934006|NCT02434328|141368967|OTHER|Treatment difference|Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|5.25|||TWO_SIDED|95.0|-12.6|8.0|||ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92||8.0|-12.6|
70934007|NCT02434328|141368967|OTHER|Treatment difference|Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|5.42|||TWO_SIDED|95.0|-13.6|7.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||7.7|-13.6|
70934008|NCT02434328|141368968|OTHER||Difference in proportions|-6.6|||||TWO_SIDED|95.0|-13.2|-0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||-0.3|-13.2|
70934009|NCT02434328|141368968|OTHER||Difference in proportions|-8.5|||||TWO_SIDED|95.0|-13.8|-3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||-3.0|-13.8|
70934010|NCT02434328|141368968|OTHER||Difference in proportions|-6.9|||||TWO_SIDED|95.0|-12.2|-1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-1.7|-12.2|
70934011|NCT02434328|141368968|OTHER||Difference in proportions|-14.2|||||TWO_SIDED|95.0|-20.8|-8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-8.3|-20.8|
70934012|NCT02434328|141368968|OTHER||Difference in proportions|3.1|||||TWO_SIDED|95.0|-2.9|9.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||9.6|-2.9|
70934013|NCT02434328|141368968|OTHER||Difference in proportions|-19.2|||||TWO_SIDED|95.0|-25.5|-13.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-13.0|-25.5|
70934014|NCT02434328|141368968|OTHER||Difference in proportions|-5.9|||||TWO_SIDED|95.0|-11.6|-0.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||-0.4|-11.6|
70934015|NCT02434328|141368968|OTHER||Difference in proportions|-9.8|||||TWO_SIDED|95.0|-16.5|-3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||-3.5|-16.5|
70934016|NCT02434328|141368968|OTHER||Difference in proportions|-8.0|||||TWO_SIDED|95.0|-13.6|-2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-2.5|-13.6|
70934017|NCT02434328|141368968|OTHER||Difference in proportions|-15.4|||||TWO_SIDED|95.0|-21.5|-9.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-9.4|-21.5|
70934018|NCT02434328|141368968|OTHER||Difference in proportions|2.5|||||TWO_SIDED|95.0|-3.2|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||8.4|-3.2|
70934019|NCT02434328|141368968|OTHER||Difference in proportions|-15.9|||||TWO_SIDED|95.0|-22.4|-10.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-10.4|-22.4|
70934020|NCT02434328|141368968|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-8.5|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||3.1|-8.5|
70934021|NCT02434328|141368968|OTHER||Difference in proportions|-9.0|||||TWO_SIDED|95.0|-15.7|-2.9|||Regression, Logistic|Hypothesis testing not pre-specified.|Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||-2.9|-15.7|
71107828|NCT01493089|141721431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.755|TWO_SIDED|95.0|-15.0|10.6|||Regression, Cox|||Sustained response||10.6|-15.0|0.755
71022990|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.96|||||TWO_SIDED|95.0|-24.52|50.45||||||For change in pancreatic pain at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||50.45|-24.52|
71022991|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.15|||||TWO_SIDED|95.0|-76.41|30.11||||||For change in eating related items at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||30.11|-76.41|
71022992|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.44|||||TWO_SIDED|95.0|-71.89|33.0||||||For change in altered bowel habits at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||33.00|-71.89|
71022993|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.22|||||TWO_SIDED|95.0|7.31|87.13||||||For change in jaundice at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||87.13|7.31|
70934022|NCT02434328|141368968|OTHER||Difference in proportions|-3.9|||||TWO_SIDED|95.0|-9.8|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||2.2|-9.8|
71022994|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.67|||||TWO_SIDED|95.0|-36.0|119.34||||||For change in body image at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||119.34|-36.00|
71022995|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.89|||||TWO_SIDED|95.0|-5.05|82.83||||||For change in health care satisfaction at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||82.83|-5.05|
71022996|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.14|||||TWO_SIDED|95.0|-2.09|66.37||||||For change in sexual functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||66.37|-2.09|
71022997|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.41|||||TWO_SIDED|95.0|-44.46|29.64||||||For change in indigestion at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||29.64|-44.46|
71022998|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.96|||||TWO_SIDED|95.0|-40.45|66.37||||||For change in flatulence at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||66.37|-40.45|
71022999|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.89|||||TWO_SIDED|95.0|-32.71|60.49||||||For change in cachexia at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||60.49|-32.71|
71023000|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.86|||||TWO_SIDED|95.0|-16.16|77.89||||||For change in side effects at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||77.89|-16.16|
71056525|NCT00315731|141617309|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of AUC values after dosimetric dose of fission-derived 131I-tositumomab with historical data from tellurium-derived 131I-tositumomab|Ratio of AUC(0-168)|0.96|||||TWO_SIDED|90.0|0.83|1.11|||||Ratio of AUC(0-168) is the ratio of AUC(0-168) values following infusion of fission-derived 131I-tositumomab to those following infusion of tellurium-derived 131I-tositumomab.|||1.11|0.83|
71056526|NCT00315731|141617310|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of AUC values after dosimetric dose of fission-derived 131I-tositumomab with historical data from tellurium-derived 131I-tositumomab|Ratio of AUC(0 to infinity)|0.93|||||TWO_SIDED|90.0|0.78|1.1||||||||1.10|0.78|
71056527|NCT00315731|141617311|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of AUC values after dosimetric dose of fission-derived 131I-tositumomab with historical data from tellurium-derived 131I-tositumomab|Ratio of Cmax|0.98|||||TWO_SIDED|90.0|0.87|1.11||||||||1.11|0.87|
71056528|NCT04614246|141617319|OTHER||LS-Mean|-1.63|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|80.0|-2.13|-1.14|||Mixed Models Analysis|||80% confidence interval (CI) for change in mean worst EAPP from baseline to Week 12||-1.14|-2.13|
71056529|NCT04614246|141617319|OTHER||LS-Mean|-2.13|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|80.0|-2.66|-1.61|||Mixed Models Analysis|||80% confidence interval (CI) for change in mean worst EAPP from baseline to Week 12||-1.61|-2.66|
71056530|NCT04614246|141617319|OTHER||LS-Mean|-1.96|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|80.0|-2.48|-1.43|||Mixed Models Analysis|||80% confidence interval (CI) for change in mean worst EAPP from baseline to Week 12||-1.43|-2.48|
71056531|NCT04614246|141617319|OTHER||LS-Mean|-1.94|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|80.0|-2.44|-1.45|||Mixed Models Analysis|||80% confidence interval (CI) for change in mean worst EAPP from baseline to Week 12||-1.45|-2.44|
71023001|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.83|||||TWO_SIDED|95.0|-44.95|86.62||||||For change in fear of future health at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||86.62|-44.95|
71023002|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.52|||||TWO_SIDED|95.0|-115.22|78.19||||||For change in ability to plan future at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||78.19|-115.22|
71023003|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.46|||||TWO_SIDED|95.0|-39.71|86.63||||||For change in pancreatic pain at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||86.63|-39.71|
71023004|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.96|||||TWO_SIDED|95.0|-130.69|104.76||||||For change in eating related items at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||104.76|-130.69|
71023005|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|48.15|||||TWO_SIDED|95.0|-7.12|103.42||||||For change in altered bowel habits at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||103.42|-7.12|
71023006|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|92.59|||||TWO_SIDED|95.0|63.16|122.02||||||For change in jaundice at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||122.02|63.16|
71023007|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.56|||||TWO_SIDED|95.0|-85.03|96.14||||||For change in body image at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||96.14|-85.03|
71023008|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.04|||||TWO_SIDED|95.0|-29.46|103.54||||||For change in health care satisfaction at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||103.54|-29.46|
71023009|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.14|||||TWO_SIDED|95.0|-41.45|27.16||||||For change in sexual functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||27.16|-41.45|
71023010|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7|||||TWO_SIDED|95.0|-67.04|59.64||||||For change in ascites at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||59.64|-67.04|
71023011|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.41|||||TWO_SIDED|95.0|-104.79|89.97||||||For change in indigestion at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||89.97|-104.79|
71023012|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.22|||||TWO_SIDED|95.0|-58.8|103.25||||||For change in flatulence at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||103.25|-58.80|
71023013|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.78|||||TWO_SIDED|95.0|-36.28|91.83||||||For change in cachexia at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||91.83|-36.28|
71023014|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.11|||||TWO_SIDED|95.0|-74.3|96.52||||||For change in side effects at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||96.52|-74.30|
71023015|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.17|||||TWO_SIDED|95.0|-142.55|84.21||||||For change in fear of future health at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||84.21|-142.55|
70851703|NCT02448641|141191271|SUPERIORITY||Mean Difference (Net)|0.58||||0.5347|TWO_SIDED|95.0|-1.26|2.43||Combined SB623 vs. Sham at month 6 MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|MMRM included treatment, visit, pooled site, corresponding Baseline sub-domain T-score, Baseline mRS score, and the treatment-by-visit interaction|LSMD (Least square mean difference) (SE): 0.58 (0.934)|Statistical Analysis: NeuroQOL score for Lower Extremity Function (Represents Mean Change from Baseline in T-Scores at Month 6)||2.43|-1.26|0.5347
70851704|NCT02448641|141191273|SUPERIORITY||Mean Difference (Net)|1.2||||0.2959|TWO_SIDED|95.0|-1.1|3.6||MMRM: Mixed effect Model Repeat Measurement|Mixed Models Analysis|MMRM included treatment, visit, pooled site, corresponding Baseline sub-domain T-score, Baseline mRS score, and the treatment-by-visit interaction|LSMD (Least square mean difference) (SE): 1.2 (1.18)|"Change from Baseline at Month 6~Between-group Effect size is calculated as the LS mean difference divided by the model estimate of the pooled SD, obtained from the square root of the diagonal element, associated with the analysis visit summarized, from the covariance matrix."||3.6|-1.1|0.2959
71023016|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-55.56|||||TWO_SIDED|95.0|-212.46|101.35||||||For change in ability to plan future at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||101.35|-212.46|
71023017|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.67|||||TWO_SIDED|95.0|-62.93|96.26||||||For change in pancreatic pain at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||96.26|-62.93|
71023018|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.29|||||TWO_SIDED|95.0|-87.74|116.31||||||For change in eating related items at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||116.31|-87.74|
71023019|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|73.81|||||TWO_SIDED|95.0|7.9|139.72||||||For change in altered bowel habits at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||139.72|7.90|
71056532|NCT04614246|141617320|OTHER|mixed model repeated measures|Difference of least square-mean|0.29|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-0.77|1.35||||||Difference of least square-mean (95% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS||1.35|-0.77|
71056533|NCT04614246|141617320|OTHER|mixed model repeated measures (MMRM)|Difference of least square-mean|-0.18|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|95.0|-1.27|0.91||||||Difference of least square-mean (95% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS||0.91|-1.27|
71056534|NCT04614246|141617320|OTHER|mixed model repeated measures (MMRM)|Difference of least square-mean|-0.08|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|98.0|-1.17|1.02||||||Difference of least square-mean (95% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS||1.02|-1.17|
71056535|NCT04614246|141617320|OTHER|mixed model repeated measures (MMRM)|Difference of least square-mean|0.29|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|80.0|-0.4|0.98||||||Difference of least square-mean (80% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS||0.98|-0.4|
71056536|NCT04614246|141617320|OTHER|mixed model repeated measures (MMRM)|Difference of least square-mean|-0.18|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|80.0|-0.89|0.53||||||Difference of least square-mean (80% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS||0.53|-0.89|
71056537|NCT04614246|141617320|OTHER|mixed model repeated measures (MMRM)|Difference of least square-mean|-0.08|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|80.0|-0.79|0.64||||||Difference of least square-mean (80% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS||0.64|-0.79|
71056538|NCT00602641|141617443|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Presuming the control over the experimental arm (MPT-T/mPR-R), the inferiority of mPR-R was defined as a PFS treatment hazard ratio (HR) of less than or equal to 0.82 corresponding to median PFS on the mPR-R arm of 20.5 months (mos) vs. 25 mos on the MPT-T arm. With 304 patients and 221 PFS events, there was 86% power to detect non-inferiority of mPR-R at a 1-sided 0.05 significance level assuming a superiority alternative of HR=1.2 corresponding to median PFS on the mPR-R arm of 30 mos.|Hazard Ratio (HR)|0.84|||||TWO_SIDED|90.0|0.67|1.045|||||Analysis based on stratified cox regression by ISS stage (I-II vs. III) and age (\< 65y vs. ≥ 65y). The fact that the lower-bound was less than 0.82 and the upper bound was above 1.0 indicates that results were inconclusive for the primary objective.|Since mPR-R was expected to be considerably less toxic and to confer slightly longer PFS, a non-inferiority design with superiority alternative was used.||1.045|0.67|
71023020|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|76.19|||||TWO_SIDED|95.0|33.64|118.74||||||For change in jaundice at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||118.74|33.64|
71023021|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.57|||||TWO_SIDED|95.0|-64.64|121.79||||||For change in body image at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||121.79|-64.64|
71023022|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.71|||||TWO_SIDED|95.0|-28.11|99.53||||||For change in health care satisfaction at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||99.53|-28.11|
71023023|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.33|||||TWO_SIDED|95.0|-104.01|77.34||||||For change in sexual functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||77.34|-104.01|
71023024|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.44|||||TWO_SIDED|95.0|-140.03|51.14||||||For change in ascites at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||51.14|-140.03|
71023025|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.76|||||TWO_SIDED|95.0|-88.45|97.98||||||For change in indigestion at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||97.98|-88.45|
71023026|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.29|||||TWO_SIDED|95.0|-54.32|82.89||||||For change in flatulence at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||82.89|-54.32|
71023027|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.81|||||TWO_SIDED|95.0|-66.45|114.07||||||For change in cachexia at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||114.07|-66.45|
71023028|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.75|||||TWO_SIDED|95.0|-56.14|119.63||||||For change in side effects at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||119.63|-56.14|
70934023|NCT02434328|141368968|OTHER||Difference in proportions|-15.1|||||TWO_SIDED|95.0|-21.3|-8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-8.4|-21.3|
71023029|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.0|||||TWO_SIDED|95.0|-163.35|63.35||||||For change in fear of future health at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||63.35|-163.35|
71023030|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.29|||||TWO_SIDED|95.0|-125.23|96.66||||||For change in ability to plan future at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||96.66|-125.23|
71023031|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.0|||||TWO_SIDED|95.0|-45.18|95.18||||||For change in pancreatic pain at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||95.18|-45.18|
71023032|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.0|||||TWO_SIDED|95.0|-45.18|95.18||||||For change in eating related items at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||95.18|-45.18|
71056539|NCT00602641|141617444|SUPERIORITY_OR_OTHER_LEGACY|||||||0.476|TWO_SIDED||||||Log Rank|Analysis was based on stratified cox regression by ISS stage (I-II vs. III) and age (\< 65y vs. ≥ 65y).||||||0.476
71056540|NCT00602641|141617445|SUPERIORITY_OR_OTHER_LEGACY|||||||0.204|TWO_SIDED||||||Fisher Exact|||||||0.204
71023033|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|77.78|||||TWO_SIDED|95.0|14.55|141.0||||||For change in altered bowel habits at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||141.00|14.55|
71023034|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|86.11|||||TWO_SIDED|95.0|40.61|131.61||||||For change in jaundice at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||131.61|40.61|
71023035|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.0|||||TWO_SIDED|95.0|-56.48|106.48||||||For change in body image at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||106.48|-56.48|
71023036|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.22|||||TWO_SIDED|95.0|-37.69|132.13||||||For change in health care satisfaction at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||132.13|-37.69|
71023037|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.0|||||TWO_SIDED|95.0|-70.68|110.68||||||For change in sexual functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||110.68|-70.68|
71023038|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.33|||||TWO_SIDED|95.0|-91.87|25.2||||||For change in ascites at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||25.20|-91.87|
71023039|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.78|||||TWO_SIDED|95.0|-41.89|97.45||||||For change in indigestion at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||97.45|-41.89|
71023040|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.67|||||TWO_SIDED|95.0|-34.03|67.36||||||For change in flatulence at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||67.36|-34.03|
71056541|NCT00602641|141617446|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.007
71056542|NCT00070499|141617461|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073||95.0|||||Fisher Exact|||||||0.073
71056543|NCT00070499|141617461|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||95.0|||||Fisher Exact|||||||0.31
71056544|NCT00070499|141617463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||95.0|||||Log Rank|||Log-rank test of overall survival||||0.29
71056545|NCT00070499|141617463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0|||||Log Rank|||Log-rank test of overall survival||||0.55
71023041|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.33|||||TWO_SIDED|95.0|-100.19|116.86||||||For change in cachexia at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||116.86|-100.19|
71023042|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.93|||||TWO_SIDED|95.0|-53.73|105.58||||||For change in side effects at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||105.58|-53.73|
71023043|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-117.07|117.07||||||For change in ability to plan future at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||117.07|-117.07|
71023044|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.89|||||TWO_SIDED|95.0|-221.53|249.31||||||For change in pancreatic pain at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||249.31|-221.53|
71056546|NCT00070499|141617464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.074||95.0|||||Log Rank|||Log-rank test of relapse-free survival||||0.074
71023045|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.56|||||TWO_SIDED|95.0|-260.62|271.74||||||For change in eating related items at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||271.74|-260.62|
71023046|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|66.67|||||TWO_SIDED|95.0|-152.41|285.75||||||For change in altered bowel habits at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||285.75|-152.41|
71023047|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|100.0|||||TWO_SIDED|95.0|-119.08|319.08||||||For change in jaundice at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||319.08|-119.08|
71023048|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.33|||||TWO_SIDED|95.0|-185.75|252.41||||||For change in body image at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||252.41|-185.75|
71023049|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|44.44|||||TWO_SIDED|95.0|-82.04|170.93||||||For change in health care satisfaction at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||170.93|-82.04|
71023050|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-733.59|733.59||||||For change in sexual functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||733.59|-733.59|
71023051|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.11|||||TWO_SIDED|95.0|-202.34|180.12||||||For change in ascites at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||180.12|-202.34|
71023052|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.11|||||TWO_SIDED|95.0|-84.5|106.73||||||For change in indigestion at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||106.73|-84.50|
71023053|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.11|||||TWO_SIDED|95.0|-84.5|106.73||||||For change in flatulence at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||106.73|-84.50|
71023054|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.89|||||TWO_SIDED|95.0|-87.6|165.37||||||For change in cachexia at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||165.37|-87.60|
71023055|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|44.44|||||TWO_SIDED|95.0|-208.53|297.42||||||For change in side effects at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||297.42|-208.53|
70934024|NCT02434328|141368968|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-6.1|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||6.2|-6.1|
71023056|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.22|||||TWO_SIDED|95.0|-275.19|230.75||||||For change in ability to plan future at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||230.75|-275.19|
71023057|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|58.33|||||TWO_SIDED|95.0|-491.86|608.53||||||For change in pancreatic pain at EoS, mean change difference was used to compare the two treatment groups.||608.53|-491.86|
71023058|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.0|||||TWO_SIDED|95.0|-1258.79|1308.79||||||For change in eating related items at EoS, mean change difference was used to compare the two treatment groups.||1308.79|-1258.79|
71023059|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|83.33|||||TWO_SIDED|95.0|-283.46|450.13||||||For change in altered bowel habits at EoS, mean change difference was used to compare the two treatment groups.||450.13|-283.46|
71023060|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.33|||||TWO_SIDED|95.0|-175.06|191.73||||||For change in jaundice at EoS, mean change difference was used to compare the two treatment groups.||191.73|-175.06|
71023061|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-733.59|733.59||||||For change in ascites at EoS, mean change difference was used to compare the two treatment groups.||733.59|-733.59|
71023062|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-733.59|733.59||||||For change in indigestion at EoS, mean change difference was used to compare the two treatment groups.||733.59|-733.59|
71023063|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|83.33|||||TWO_SIDED|95.0|-283.46|450.13||||||For change in flatulence at EoS, mean change difference was used to compare the two treatment groups.||450.13|-283.46|
71023064|NCT00219557|141553676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.56|||||TWO_SIDED|95.0|-1375.5|1436.61||||||For change in side effects at EoS, mean change difference was used to compare the two treatment groups.||1436.61|-1375.5|
71056547|NCT00070499|141617464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||95.0|||||Log Rank|||Log-rank test of relapse-free survival||||0.29
71056548|NCT01371747|141617517|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
71056549|NCT01371747|141617517|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-Value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
71056550|NCT01371747|141617517|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
71056551|NCT01371747|141617517|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
71056552|NCT01371747|141617517|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
71107829|NCT01493089|141721431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8||||0.194|TWO_SIDED|95.0|-3.6|17.2|||Regression, Cox|||Sustained total relief||17.2|-3.6|0.194
71107830|NCT01493089|141721432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.501|TWO_SIDED|95.0|-15.0|7.0|||Regression, Cox|||Sustained partial response||7.0|-15.0|0.501
71107831|NCT01493089|141721432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7||||0.518|TWO_SIDED|95.0|-17.6|8.2|||Regression, Cox|||Sustained response||8.2|-17.6|0.518
71107832|NCT01493089|141721432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.794|TWO_SIDED|95.0|-11.2|13.1|||Regression, Cox|||Sustained total relief||13.1|-11.2|0.794
71107833|NCT01493089|141721433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4||||0.494|TWO_SIDED|95.0|-6.3|11.2|||Regression, Cox|||Sustained partial response||11.2|-6.3|0.494
71107834|NCT01493089|141721433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.751|TWO_SIDED|95.0|-14.7|9.1|||Regression, Cox|||Sustained response||9.1|-14.7|0.751
71107835|NCT01493089|141721433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.69|TWO_SIDED|95.0|-16.4|9.6|||Regression, Cox|||Sustained total relief||9.6|-16.4|0.690
70934025|NCT02434328|141368968|OTHER||Difference in proportions|-16.6|||||TWO_SIDED|95.0|-22.6|-10.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-10.5|-22.6|
71023065|NCT00479401|141553740|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority hypothesis comparing pramipexole ER to pramipexole IR was to be tested using a non-inferiority margin of -3 points. The primary efficacy endpoint in UPDRS part II+III was the change from baseline (week 0) to week 33 on the UPDRS Parts II+III score combined. The statistical model was analysis of covariance, controlling for baseline UPDRS Part II+III. Fixed terms in the model were treatment, country, and UPDRS Part II+III score at baseline.|Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-2.2|1.7|||ANCOVA|Null hypothesis was tested using an analysis of covariance model with α = 0.05 in full analysis set with last observation carried forward.|PPX ER non-inferior to PPX IR, if the lower limit of the confidence interval for the difference is higher than the non-inferiority margin of -3|A non-inferiority hypothesis (H0: μER - μIR \< -3 vs. H1: μER - μIR ≥ -3) comparing pramipexole ER to pramipexole IR was tested using a non-inferiority margin of -3 points.||1.7|-2.2|
71023066|NCT02868281|141553765|OTHER||Odds Ratio (OR)|7.87||||0.027|TWO_SIDED|95.0|1.29|48.11|||Mixed effect logistic regression||The model included treatment, Baseline ACT total score, Baseline ACT total score squared, center, type of Baseline controller, gender and age, with the center as a random factor.|||48.11|1.29|0.027
71056553|NCT01371747|141617517|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
71056554|NCT01371747|141617518|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-Value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
71056555|NCT01371747|141617518|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-Value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
71056556|NCT01371747|141617518|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
71056557|NCT01371747|141617518|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
71056558|NCT01371747|141617518|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
71056559|NCT01371747|141617518|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
71107836|NCT03012334|141721434|NON_INFERIORITY|Doses of lasmiditan were considered non-inferior to placebo if the upper 95% confidence limit on the difference in Standard Deviation of Lateral Position (SDLP) between that dose and placebo was less than 4.4 cm and lower doses also did not exceed the non-inferiority (NI) margin.|LS Mean|9.86|||<|0.001|TWO_SIDED|95.0|7.39|12.33||P-value is obtained from mixed effect model for testing difference versus placebo equals to zero.|Mixed Models Analysis|||||12.33|7.39|<.001
71107837|NCT03012334|141721434|NON_INFERIORITY|Doses of lasmiditan were considered non-inferior to placebo if the upper 95% confidence limit on the difference in SDLP between that dose and placebo was less than 4.4 cm and lower doses also did not exceed the non-inferiority (NI) margin.|LS Mean|15.35|||<|0.001|TWO_SIDED|95.0|12.87|17.82||P-value is obtained from mixed effect model for testing difference versus placebo equals to zero.|Mixed Models Analysis|||||17.82|12.87|<0.001
71107838|NCT03012334|141721434|NON_INFERIORITY|Doses of lasmiditan were considered non-inferior to placebo if the upper 95% confidence limit on the difference in SDLP between that dose and placebo was less than 4.4 cm and lower doses also did not exceed the non-inferiority (NI) margin.|LS Mean|21.06|||<|0.001|TWO_SIDED|95.0|18.6|23.52||P-value is obtained from mixed effect model for testing difference versus placebo equals to zero.|Mixed Models Analysis|||||23.52|18.60|<0.001
71107839|NCT03012334|141721434|SUPERIORITY||LS Mean|22.71|||<|0.001|TWO_SIDED|95.0|20.23|25.18|||Mixed Models Analysis|||||25.18|20.23|<0.001
71107840|NCT03012334|141721434|SUPERIORITY||LS Mean|-12.85|||<|0.001|TWO_SIDED|95.0|-15.32|-10.38|||Mixed Models Analysis|||||-10.38|-15.32|<0.001
71107841|NCT03012334|141721434|SUPERIORITY||LS Mean|-7.36|||<|0.001|TWO_SIDED|95.0|-9.84|-4.88|||Mixed Models Analysis|||||-4.88|-9.84|<0.001
71107842|NCT03012334|141721434|SUPERIORITY||LS Mean|-1.65||||0.19|TWO_SIDED|95.0|-4.11|0.82|||Mixed Models Analysis|||||0.82|-4.11|0.19
71107843|NCT03012334|141721435|SUPERIORITY||LS Mean|1.6|||<|0.0001|TWO_SIDED|95.0|1.1744|2.0335|||Mixed Models Analysis|||||2.0335|1.1744|<0.0001
71107844|NCT03012334|141721435|SUPERIORITY||LS Mean|2.3|||<|0.0001|TWO_SIDED|95.0|1.8306|2.6926|||Mixed Models Analysis|||||2.6926|1.8306|<.0001
71107845|NCT03012334|141721435|SUPERIORITY||LS Mean|2.9|||<|0.0001|TWO_SIDED|95.0|2.4239|3.28|||Mixed Models Analysis|||||3.2800|2.4239|<0.0001
71107846|NCT03012334|141721435|SUPERIORITY||LS Mean|3.4|||<|0.0001|TWO_SIDED|95.0|2.9568|3.8193|||Mixed Models Analysis|||||3.8193|2.9568|<0.0001
71107847|NCT03012334|141721435|SUPERIORITY||LS Mean|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.2137|-1.3546|||Mixed Models Analysis|||||-1.3546|-2.2137|<0.0001
71023067|NCT02868281|141553766|OTHER||Difference in Least Squares Mean|-0.1||||0.222|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model Repeat Measures||Weeks 1-4. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.0|-0.2|0.222
71023068|NCT02868281|141553766|OTHER||Difference in Least Squares Mean|-0.1||||0.156|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model Repeat Measures||Weeks 5-8. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.0|-0.2|0.156
71023069|NCT02868281|141553766|OTHER||Difference in Least Squares Mean|-0.1||||0.245|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model Repeat Measures||Weeks 9-12. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.0|-0.2|0.245
71023070|NCT02868281|141553766|OTHER||Difference in Least Squares Mean|-0.1||||0.057|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model Repeat Measures||Weeks 13-16. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.0|-0.2|0.057
71023071|NCT02868281|141553766|OTHER||Difference in Least Squares Mean|-0.1||||0.151|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model Repeat Measures||Weeks 17-20. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.0|-0.2|0.151
70934026|NCT02434328|141368968|OTHER||Difference in proportions|-1.1|||||TWO_SIDED|95.0|-7.0|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||5.1|-7.0|
71023072|NCT02868281|141553766|OTHER||Difference in Least Squares Mean|-0.1||||0.114|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model Repeat Measures||Weeks 21-24. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.0|-0.2|0.114
71023073|NCT02868281|141553767|OTHER||Difference in Least Squares Mean|-0.05||||0.487|TWO_SIDED|95.0|-0.18|0.09|||Mixed Model Repeat Measures||Weeks 1-4. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.09|-0.18|0.487
71023074|NCT02868281|141553767|OTHER||Difference in Least Squares Mean|-0.04||||0.546|TWO_SIDED|95.0|-0.16|0.09|||Mixed Model Repeat Measures||Weeks 5-8. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.09|-0.16|0.546
71023075|NCT02868281|141553767|OTHER||Difference in Least Squares Mean|-0.06||||0.314|TWO_SIDED|95.0|-0.17|0.06|||Mixed Model Repeat Measures||Weeks 9-12. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.06|-0.17|0.314
70934027|NCT02434328|141368968|OTHER||Difference in proportions|-11.0|||||TWO_SIDED|95.0|-17.4|-5.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||-5.0|-17.4|
70934028|NCT02434328|141368968|OTHER||Difference in proportions|-5.3|||||TWO_SIDED|95.0|-11.3|0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||0.7|-11.3|
70934029|NCT02434328|141368968|OTHER||Difference in proportions|-12.0|||||TWO_SIDED|95.0|-18.9|-5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||-5.9|-18.9|
70934030|NCT02434328|141368968|OTHER||Difference in proportions|-5.5|||||TWO_SIDED|95.0|-11.4|0.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||0.0|-11.4|
70934031|NCT02434328|141368968|OTHER||Difference in proportions|-14.5|||||TWO_SIDED|95.0|-20.3|-8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||-8.3|-20.3|
70934032|NCT02434328|141368969|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-2.5|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||5.4|-2.5|
70934033|NCT02434328|141368969|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-6.1|1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.7|-6.1|
70934034|NCT02434328|141368969|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-5.3|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.2|-5.3|
70934035|NCT02434328|141368969|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-4.5|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||4.4|-4.5|
70934036|NCT02434328|141368969|OTHER||Difference in proportions|8.2|||||TWO_SIDED|95.0|3.9|12.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||12.8|3.9|
70934037|NCT02434328|141368969|OTHER||Difference in proportions|-3.2|||||TWO_SIDED|95.0|-7.9|1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||1.2|-7.9|
70934038|NCT02434328|141368969|OTHER||Difference in proportions|2.8|||||TWO_SIDED|95.0|-1.0|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||6.4|-1.0|
70934039|NCT02434328|141368969|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-5.5|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.0|-5.5|
71056560|NCT01371747|141617519|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-Value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
70934040|NCT02434328|141368969|OTHER||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-5.6|1.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||1.8|-5.6|
70934041|NCT02434328|141368969|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-6.0|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||3.1|-6.0|
71056561|NCT01371747|141617519|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-Value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
71056562|NCT01371747|141617519|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
71056563|NCT01371747|141617519|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
71056564|NCT01371747|141617519|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
71056565|NCT01371747|141617519|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
70934042|NCT02434328|141368969|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-0.5|8.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||8.0|-0.5|
70934043|NCT02434328|141368969|OTHER||Difference in proportions|-2.0|||||TWO_SIDED|95.0|-6.2|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||2.2|-6.2|
70934044|NCT02434328|141368969|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.5|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||5.1|-2.5|
70934045|NCT02434328|141368969|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-5.9|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||3.1|-5.9|
70851705|NCT02448641|141191274|SUPERIORITY||Odds Ratio (OR)|1.36||||0.6854|TWO_SIDED|95.0|0.31|5.92||GLMM: Generalized Linear Mixed Model|Mixed Models Analysis|A GLMM with FMMS responder as outcome, treatment, visit, treatment-visit interaction, pooled site, Baseline FMMS and Baseline mRS scores as covariates||Combined SB623 Implant Vs Sham Surgery group at Month 6||5.92|0.31|0.6854
70934046|NCT02434328|141368969|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-4.4|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.4|-4.4|
70934047|NCT02434328|141368969|OTHER||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-6.2|2.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||2.1|-6.2|
70934048|NCT02434328|141368969|OTHER||Difference in proportions|2.6|||||TWO_SIDED|95.0|-1.2|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||6.5|-1.2|
71023076|NCT02868281|141553767|OTHER||Difference in Least Squares Mean|-0.07||||0.197|TWO_SIDED|95.0|-0.19|0.04|||Mixed Model Repeat Measures||Weeks 13-16. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.04|-0.19|0.197
71023077|NCT02868281|141553767|OTHER||Difference in Least Squares Mean|-0.06||||0.282|TWO_SIDED|95.0|-0.17|0.06|||Mixed Model Repeat Measures||Weeks 17-20. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.06|-0.17|0.282
71023078|NCT02868281|141553767|OTHER||Difference in Least Squares Mean|-0.03||||0.543|TWO_SIDED|95.0|-0.15|0.08|||Mixed Model Repeat Measures||Weeks 21-24. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.08|-0.15|0.543
71023079|NCT02868281|141553768|OTHER||Difference in Least Squares Mean|0.06||||0.273|TWO_SIDED|95.0|-0.059|0.18|||Mixed Model Repeat Measures||The model included covariates of treatment, center, Baseline FEV1, type of Baseline controller, gender and age, with the center as a random factor.|||0.180|-0.059|0.273
71023080|NCT02868281|141553769|OTHER||Difference in Least Squares Mean|-12.0||||0.367|TWO_SIDED|95.0|-40.3|16.3|||Mixed Model Repeat Measures||Weeks 1-4. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||16.3|-40.3|0.367
71023081|NCT02868281|141553769|OTHER||Difference in Least Squares Mean|-7.2||||0.587|TWO_SIDED|95.0|-35.5|21.2|||Mixed Model Repeat Measures||Weeks 5-8. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||21.2|-35.5|0.587
71056566|NCT01371747|141617520|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.54|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
71056567|NCT01371747|141617520|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.44|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
71056568|NCT01371747|141617520|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.5|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
71056569|NCT01371747|141617520|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.0|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
71056570|NCT01371747|141617520|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.96|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
71056571|NCT01371747|141617520|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.17|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
71056572|NCT01371747|141617521|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.36|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
70934049|NCT02434328|141368969|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-4.2|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||4.3|-4.2|
71056573|NCT01371747|141617521|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.22|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
71056574|NCT01371747|141617521|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.3|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
71023082|NCT02868281|141553769|OTHER||Difference in Least Squares Mean|-4.7||||0.721|TWO_SIDED|95.0|-33.1|23.7|||Mixed Model Repeat Measures||Weeks 9-12. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||23.7|-33.1|0.721
71023083|NCT02868281|141553769|OTHER||Difference in Least Squares Mean|-3.3||||0.801|TWO_SIDED|95.0|-31.7|25.1|||Mixed Model Repeat Measures||Weeks 13-16. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||25.1|-31.7|0.801
71023084|NCT02868281|141553769|OTHER||Difference in Least Squares Mean|-5.0||||0.704|TWO_SIDED|95.0|-33.3|23.4|||Mixed Model Repeat Measures||Weeks 17-20. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||23.4|-33.3|0.704
71023085|NCT02868281|141553769|OTHER||Difference in Least Squares Mean|-4.0||||0.762|TWO_SIDED|95.0|-32.4|24.5|||Mixed Model Repeat Measures||Weeks 21-24. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||24.5|-32.4|0.762
71023086|NCT02868281|141553770|OTHER||Difference in Least Squares Mean|-12.8||||0.354|TWO_SIDED|95.0|-42.1|16.5|||Mixed Model Repeat Measures||Weeks 1-4. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||16.5|-42.1|0.354
70934050|NCT02434328|141368969|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-3.5|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.2|-3.5|
70934051|NCT02434328|141368969|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-4.8|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||4.3|-4.8|
70934052|NCT02434328|141368969|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-3.3|5.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||5.2|-3.3|
70934053|NCT02434328|141368969|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-4.5|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.9|-4.5|
71023087|NCT02868281|141553770|OTHER||Difference in Least Squares Mean|-8.4||||0.538|TWO_SIDED|95.0|-37.8|21.0|||Mixed Model Repeat Measures||Weeks 5-8. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||21.0|-37.8|0.538
71023088|NCT02868281|141553770|OTHER||Difference in Least Squares Mean|-5.0||||0.716|TWO_SIDED|95.0|-34.4|24.5|||Mixed Model Repeat Measures||Weeks 9-12. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||24.5|-34.4|0.716
71023089|NCT02868281|141553770|OTHER||Difference in Least Squares Mean|-3.1||||0.822|TWO_SIDED|95.0|-32.5|26.3|||Mixed Model Repeat Measures||Weeks 13-16. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||26.3|-32.5|0.822
71023090|NCT02868281|141553770|OTHER||Difference in Least Squares Mean|-4.0||||0.767|TWO_SIDED|95.0|-33.4|25.4|||Mixed Model Repeat Measures||Weeks 17-20. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||25.4|-33.4|0.767
71023091|NCT02868281|141553770|OTHER||Difference in Least Squares Mean|-3.8||||0.779|TWO_SIDED|95.0|-33.4|25.7|||Mixed Model Repeat Measures||Weeks 21-24. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||25.7|-33.4|0.779
71056575|NCT01371747|141617521|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.41|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
71056576|NCT01371747|141617521|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.39|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
71056577|NCT01371747|141617521|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.58|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
71023092|NCT02868281|141553771|OTHER||Difference in Least Squares Mean|0.3||||0.059|TWO_SIDED|95.0|0.0|0.6|||Mixed Model Repeat Measures||The model included covariates of treatment, center, Baseline AQLQ(S) score, type of Baseline controller, gender and age, with the center as a random factor.|||0.6|-0.0|0.059
71023093|NCT02868281|141553772|OTHER||Hazard Ratio (HR)|1.843||||0.01|TWO_SIDED|95.0|1.16|2.926|||Cox proportional hazards model||The model included treatment, Baseline ACT total score, center, type of Baseline controller, gender and age as covariates.|||2.926|1.160|0.010
71023094|NCT02868281|141553773|OTHER||Rate Ratio|1.09||||0.897|TWO_SIDED|95.0|0.32|3.73|||Generalised linear model||The model included treatment, Baseline ACT total score, type of Baseline controller, gender and age as covariates.|||3.73|0.32|0.897
71056578|NCT01371747|141617522|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|100.0|||||TWO_SIDED|95.0|94.3|100.0|||||2-sided 95% exact binomial CI|||100.0|94.3|
71056579|NCT01371747|141617522|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|100.0|||||TWO_SIDED|95.0|94.5|100.0|||||2-sided 95% exact binomial CI|||100|94.5|
71056580|NCT01371747|141617522|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|98.4|||||TWO_SIDED|95.0|91.6|100.0|||||2-sided 95% exact binomial CI|||100|91.6|
71107848|NCT03012334|141721435|SUPERIORITY||LS Mean|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.5574|-0.6956|||Mixed Models Analysis|||||-0.6956|-1.5574|<0.0001
71023095|NCT03124381|141553792|NON_INFERIORITY|Non-inferiority concluded if the upper bound of the two-sided 95% confidence interval (based on ANCOVA) is less than 15 percentage points. Terms for treatment, gender, center as factors and baseline as covariate.|Mean Difference (Net)|3.19|STANDARD_ERROR_OF_MEAN|5.164|||TWO_SIDED|95.0|-7.04|13.42||||||Non-inferiority test performed after significance vs. baseline confirmed for each cell. The null hypothesis for the non-inferiority test was H0: A-B≥15%, where A and B are the mean percent change at Week 12 of global face total acne lesion count of the Gel-Cream + Acne Mask cell and Acne Mask cell, respectively.||13.42|-7.04|
71023096|NCT03124381|141553792|SUPERIORITY|Superiority concluded if the upper bound of the two-sided 95% confidence interval of the treatment difference is less than 0. Terms for treatment, gender, and center as factors and baseline score as covariate.|Mean Difference (Net)|3.19|STANDARD_ERROR_OF_MEAN|5.164||0.538|TWO_SIDED|95.0|-7.04|13.42|||ANCOVA|||Superiority test performed after non-inferiority confirmed as described above. The null hypothesis for the superiority test was H0: A-B = 0, where A and B are the mean percent change at Week 12 of global face total acne lesion count of the Acne Mask and the Gel-Cream + Acne Mask cell, respectively.||13.42|-7.04|0.538
71023097|NCT00291330|141553842|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin was set up to 2.75 for the HR analysis|Hazard Ratio (HR)|1.05|||<|0.0001||95.0|0.65|1.7||Non-inferiority P-Value. Two Statistical analyses performed on primary endpoint. Both non inferiority for the risk difference and for the hazard ratio analyses to be reached in order to conclude positively on the primary endpoint.|Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the primary endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.70|0.65|<0.0001
71056581|NCT01371747|141617522|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|91.7|||||TWO_SIDED|95.0|73.0|99.0|||||2-sided 95% exact binomial CI|||99|73|
71056582|NCT01371747|141617522|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|95.8|||||TWO_SIDED|95.0|78.9|99.9|||||2-sided 95% exact binomial CI|||99.9|78.9|
71056583|NCT01371747|141617522|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|95.5|||||TWO_SIDED|95.0|77.2|99.9|||||2-sided 95% exact binomial CI|||99.9|77.2|
71056584|NCT01371747|141617523|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|95.2|||||TWO_SIDED|95.0|86.7|99.0|||||2-sided 95% exact binomial CI|||99.0|86.7|
71056585|NCT01371747|141617523|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|90.8|||||TWO_SIDED|95.0|81.0|96.5|||||2-sided 95% exact binomial CI|||96.5|81.0|
71056586|NCT01371747|141617523|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|81.3|||||TWO_SIDED|95.0|69.5|89.9|||||2-sided 95% exact binomial CI|||89.9|69.5|
71056587|NCT01371747|141617523|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|79.2|||||TWO_SIDED|95.0|57.8|92.9|||||2-sided 95% exact binomial CI|||92.9|57.8|
71056588|NCT01371747|141617523|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|91.7|||||TWO_SIDED|95.0|73.0|99.0|||||2-sided 95% exact binomial CI|||99|73|
71056589|NCT01371747|141617523|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|77.3|||||TWO_SIDED|95.0|54.6|92.2|||||2-sided 95% exact binomial CI|||92.2|54.6|
71056590|NCT01371747|141617525|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|86.3|||||TWO_SIDED|95.0|73.7|94.3|||||2-sided 95% exact binomial CI|||94.3|73.7|
71056591|NCT01371747|141617525|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|81.6|||||TWO_SIDED|95.0|68.0|91.2|||||2-sided 95% exact binomial CI|||91.2|68.0|
71056592|NCT01371747|141617525|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|88.9|||||TWO_SIDED|95.0|75.9|96.3|||||2-sided 95% exact binomial CI|||96.3|75.9|
71056593|NCT01371747|141617525|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|86.7|||||TWO_SIDED|95.0|59.5|98.3|||||2-sided 95% exact binomial CI|||98.3|59.5|
71056594|NCT01371747|141617525|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|89.5|||||TWO_SIDED|95.0|66.9|98.7|||||2-sided 95% exact binomial CI|||98.7|66.9|
71056595|NCT01371747|141617525|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|93.3|||||TWO_SIDED|95.0|68.1|99.8|||||2-sided 95% exact binomial CI|||99.8|68.1|
71056596|NCT03092219|141617526|SUPERIORITY|||||||0.0001|TWO_SIDED|95.0|||||Fisher Exact|For this outcome measure, missing data were imputed using a LOCF (Last Observation Carried Forward) method.||||||0.0001
71056597|NCT01403051|141617567|SUPERIORITY_OR_OTHER|||||||0.001||||||2-sided test with type I error rate of 5%, not adjusted for multiple comparisons.|Stratified Wilcoxon rank sum test|Stratified Wilcoxon rank sum test for differences between the two treatment groups, stratified by the screening 25-OH vitamin (\<=20 vs. \>20 ng/mL)||The study was sized to have 80% power to detect a 2 % difference in BMD of the hip from baseline to week 48.||||0.001
71056598|NCT01701011|141617584|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||IBM SPSS Statistics 20 was used to perform the statistical analysis. A mixed model for repeated measures was used to examine the differences between the three groups over time for the primary outcome, anxiety. All models were estimated by the method of restricted maximum likelihood (REML) and the Compound Symmetry covariance structure was chosen for the repeated measures. The analysiswas performed according to the intention to treat.||||<0.05
71056599|NCT01701011|141617584|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||To test the difference in psychological well-being between three groups with a power of 95%,a ¼ 0.05 and a medium effect size ( f ¼ 0.25), a total of 297 participants were required (99 patients per group). Taking into account a 20% attrition rate, at least 124 women had to be recruited in each group.||||<0.05
71056600|NCT01701011|141617585|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||IBM SPSS Statistics 20 was used to perform the statistical analysis. A mixed model for repeated measures was used to examine the differences between the three groups over time for the secondary outcome, depression. All models were estimated by the method of restricted maximum likelihood (REML) and the Compound Symmetry covariance structure was chosen for the repeated measures. The analysiswas performed according to the intention to treat.||||<0.05
71056601|NCT00976911|141617628|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|15.7|||||TWO_SIDED|95.0|6.5|24.8||||||||24.8|6.5|
71056602|NCT00976911|141617628|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||Pearson's chi-square|unstratified analysis||||||0.0010
71023098|NCT00291330|141553842|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin was set up to 3.6% for the risk difference based on KM estimates|Risk Difference (Percentage)|0.4|||<|0.0001||95.0|-0.8|1.5||Non-inferiority P-Value. Two Statistical analyses performed on primary endpoint. Both non inferiority for the risk difference and for the hazard ratio analyses to be reached in order to conclude positively on the primary endpoint.|Kaplan Meier weighted estimates|||Risk difference vs. Warfarin for Proportion of patients with VTE or death related to VTE at 6 months. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.50|-0.80|<0.0001
71023099|NCT00291330|141553842|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||||95.0|0.65|1.84|||Regression, Cox|Patients without events are censored at day 180||Hazard ratio vs. Warfarin (events occurring between randomisation and the day 180). The time to first occurrence of the primary endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.84|0.65|
71056603|NCT00976911|141617628|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007|TWO_SIDED|||||Stratified analysis: The strata were chemotherapy selected (paclitaxel, PLD, or topotecan), prior anti-angiogenic therapy (yes or no), and platinum-free interval (\<3 or 3-6 months).|Cochran-Mantel-Haenszel|||||||0.0007
71056604|NCT00976911|141617629|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.45||||0.0202|TWO_SIDED|95.0|0.225|0.9||Unstratified analysis|Log Rank||Hazard ratio was estimated by unstratified Cox regression model.|||0.900|0.225|0.0202
71056605|NCT00976911|141617629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0081|TWO_SIDED||||||Peto-Peto-Prentice|||||||0.0081
71056606|NCT00976911|141617631|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.379|||<|0.0001|TWO_SIDED|95.0|0.296|0.485|||Log Rank||Stratified analysis:Strata were chemotherapy selected (paclitaxel, PLD, or topotecan), prior anti-angiogenic therapy (yes or no), and platinum-free interval (less than \[\<\] 3 or 3-6 months). Cox regression model was used to determine the hazard ratio.|||0.485|0.296|<0.0001
71056607|NCT00976911|141617631|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.366|0.577|||Log Rank|Unstratified analysis||||0.577|0.366|<0.0001
71056608|NCT00976911|141617631|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Peto-Peto-Prentice|Unstratified analysis||||||<0.0001
71056609|NCT00976911|141617631|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Peto-Peto-Prentice|Stratified analysis:Strata were chemotherapy selected, prior anti-angiogenic therapy, and platinum-free interval.||||||<0.0001
71056610|NCT00976911|141617632|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.833||||0.136|TWO_SIDED|95.0|0.655|1.059||Unstratified analysis|Log Rank|||||1.059|0.655|0.1360
71056611|NCT00976911|141617632|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0715|TWO_SIDED|||||Unstratified analysis|Peto-Peto-Prentice|||||||0.0715
71056612|NCT00976911|141617632|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.2711|TWO_SIDED|95.0|0.678|1.116||Stratified analysis: The strata were chemotherapy selected (paclitaxel, PLD, or topotecan), prior anti-angiogenic therapy (yes or no), and platinum-free interval (\<3 or 3-6 months).|Log Rank|||||1.116|0.678|0.2711
71056613|NCT00976911|141617632|SUPERIORITY_OR_OTHER_LEGACY|||||||0.089|TWO_SIDED|||||Stratified analysis: The strata were chemotherapy selected (paclitaxel, PLD, or topotecan), prior anti-angiogenic therapy (yes or no), and platinum-free interval (\<3 or 3-6 months).|Peto-Peto-Prentice|||||||0.0890
71056614|NCT00976911|141617633|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|8.8||||0.1859|TWO_SIDED|95.0|-3.8|21.4|||Fisher Exact||95% CI was approximated with Hauck-Anderson continuity correction.|Comparison of responders at baseline versus Week 8/9||21.4|-3.8|0.1859
71056615|NCT00976911|141617633|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|3.5||||0.8309|TWO_SIDED|95.0|-14.0|20.9|||Fisher Exact||95% CI was approximated with Hauck-Anderson continuity correction.|Comparison of responders at baseline versus at Week 16/18||20.9|-14|0.8309
71056616|NCT00976911|141617633|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|9.3||||0.579|TWO_SIDED|95.0|-15.0|34.1|||Fisher Exact||95% CI was approximated with Hauck-Anderson continuity correction.|Comparison of responders at baseline versus at Week 24||34.1|-15|0.5790
71056617|NCT00976911|141617633|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|-4.8||||0.7339|TWO_SIDED|95.0|-40.0|30.6|||Fisher Exact||95% CI was approximated with Hauck-Anderson continuity correction.|Comparison of responders at baseline versus at Week 30||30.6|-40|0.7339
71056618|NCT00447876|141617706|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|0.2|||=|0.182|TWO_SIDED|95.0|-0.06|0.46|||Fisher Exact|||The responders rate at Week 6 was compared between treatment groups by a two-sided Fisher exact test.||0.46|-0.06|=0.182
71056619|NCT00447876|141617707|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.222|||||||Cochran-Mantel-Haenszel|||Gerbershagen's Global scores were compared at Week 18 using a Cochran-Mantel-Haenszel analysis of variance statistic with adjustment to the baseline score.||||=0.222
71056620|NCT00447876|141617709|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.837|||=|0.423|TWO_SIDED|95.0|-30.94|13.266|||ANCOVA|||SPID was compared between the two treatment groups using a fixed effect analysis of covariance (ANCOVA) taking into account the SPID value as dependent variable, the baseline pain intensity as co-variable, and the treatment group as explicative variable.||13.266|-30.940|=0.423
71056621|NCT00447876|141617711|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.173|||=|0.682|TWO_SIDED|95.0|-24.64|16.294|||ANCOVA|||SPID was compared between the two treatment groups using a fixed effect ANCOVA taking into account the SPID value as dependent variable, the baseline pain intensity as co-variable, and the treatment group as explicative variable.||16.294|-24.640|=0.682
71056622|NCT00447876|141617713|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.066|||=|0.438|TWO_SIDED|95.0|-28.91|12.779|||ANCOVA|||The sum of pain threshold difference (i.e. SPID expressed as AUC) was compared between the two treatment groups using a fixed effect ANCOVA taking into account the SPID AUC value as dependent variable, the baseline pain intensity as co-variable, and the treatment group as explicative variable.||12.779|-28.910|=0.438
71056623|NCT00447876|141617715|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.594|||=|0.937|TWO_SIDED|95.0|-14.575|15.762|||ANCOVA|||The sum of pressure threshold difference (i.e. SPID expressed as AUC) was compared between the two treatment groups using a fixed effect ANCOVA taking into account the SPID AUC value as dependent variable, the baseline pain intensity as co-variable, and the treatment group as explicative variable.||15.762|-14.575|=0.937
71107849|NCT03012334|141721435|SUPERIORITY||LS Mean|-0.5||||0.0142|TWO_SIDED|95.0|-0.9642|-0.1081|||Mixed Models Analysis|||||-0.1081|-0.9642|0.0142
71023100|NCT00291330|141553843|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.3||||0.622||95.0|-1.0|1.7|||Kaplan Meier weighted estimates|||Risk difference vs. Warfarin for Proportion of patients with VTE or death at 6 months. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.70|-1.00|0.6220
71023101|NCT00291330|141553843|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9844||95.0|0.69|1.46|||Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.46|0.69|0.9844
71023102|NCT00291330|141553844|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.2||||0.6466||95.0|-1.1|0.7|||Kaplan Meier weighted estimates|||Risk difference vs. Warfarin for Proportion of patients with symptomatic DVT at 6 months. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||0.70|-1.10|0.6466
71023103|NCT00291330|141553844|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.385||95.0|0.4|1.42|||Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.42|0.40|0.3850
71023104|NCT00291330|141553845|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.3||||0.2981||95.0|-0.3|1.0|||Kaplan Meier weighted estimates|||Risk difference vs. Warfarin for Proportion of patients with symptomatic non-fatal PE at 6 months. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.00|-0.30|0.2981
71023105|NCT00291330|141553845|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.0||||0.1092||95.0|0.86|4.68|||Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||4.68|0.86|0.1092
71023106|NCT00291330|141553846|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.3||||0.5327||95.0|-1.2|0.6|||Kaplan Meier weighted estimates|||Risk difference at 6 months vs. Warfarin for Proportion of patients who died due to VTE . Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||0.60|-1.20|0.5327
71023107|NCT00291330|141553846|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.3332||95.0|0.03|3.15|||Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||3.15|0.03|0.3332
71023108|NCT00291330|141553847|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.1||||0.8018||95.0|-1.0|0.8|||Kaplan Meier weighted estimates|||Risk difference at 6 months vs. Warfarin for Proportion of patients who died from any cause. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||0.80|-1.00|0.8018
71023109|NCT00291330|141553847|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.8203||95.0|0.54|1.63|||Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.63|0.54|0.8203
71023110|NCT00291330|141553848|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.5063||95.0|0.45|1.48|||Regression, Cox|||Hazard ratio vs. Warfarin for the category major bleeding events (events occurring between 1st intake of study drug and last intake of study drug + 6 days). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.48|0.45|0.5063
71023111|NCT00291330|141553848|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.0002|TWO_SIDED|95.0|0.59|0.85|||Regression, Cox|||Hazard ratio vs. Warfarin for the category of any bleeding events (events occurring between 1st intake of study drug and last intake of study drug + 6 days). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||0.85|0.59|0.0002
71023112|NCT02033876|141553864|SUPERIORITY|||||||0.43|||||||ANCOVA|||||||0.43
71023113|NCT02033876|141553865|SUPERIORITY|||||||0.65|||||||ANCOVA|||||||0.65
71023114|NCT02033876|141553867|SUPERIORITY|||||||0.37|||||||ANCOVA|||||||0.37
71107850|NCT03012334|141721437|SUPERIORITY||LS Mean|-12.6|||<|0.0001|TWO_SIDED|95.0|-18.6895|-6.5006|||Mixed Models Analysis|||||-6.5006|-18.6895|<.0001
70851706|NCT02259088|141191286|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.8|||<|0.001|TWO_SIDED|95.0|4.1|7.5|||Cochran-Mantel-Haenszel|One-sided p-value for treatment difference is derived from the two-sided stratified Cochran-Mantel-Haenszel test using the row means score statistics.|Estimated from ANOVA (stratified) model. Stratified analysis includes DME type (focal, diffuse, honeycomb and petaloid) and Baseline BCVA(≤ 60 letters and \> 60 letters) as factors.|||7.5|4.1|<0.001
70934054|NCT02434328|141368969|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-0.1|8.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||8.0|-0.1|
70934055|NCT02434328|141368969|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-4.3|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.6|-4.3|
70934056|NCT02434328|141368970|OTHER||Difference in proportions|-3.5|||||TWO_SIDED|95.0|-8.9|1.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||1.5|-8.9|
70934057|NCT02434328|141368970|OTHER||Difference in proportions|-2.6|||||TWO_SIDED|95.0|-7.6|2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||2.5|-7.6|
70934058|NCT02434328|141368970|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-6.9|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||3.7|-6.9|
70934059|NCT02434328|141368970|OTHER||Difference in proportions|-7.8|||||TWO_SIDED|95.0|-13.0|-2.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-2.7|-13.0|
70934060|NCT02434328|141368970|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-3.6|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||6.2|-3.6|
70934061|NCT02434328|141368970|OTHER||Difference in proportions|-7.9|||||TWO_SIDED|95.0|-12.6|-3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-3.1|-12.6|
70934062|NCT02434328|141368970|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-6.8|2.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.7|-6.8|
70934063|NCT02434328|141368970|OTHER||Difference in proportions|-5.3|||||TWO_SIDED|95.0|-10.5|-0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||-0.3|-10.5|
71107851|NCT03012334|141721437|SUPERIORITY||LS Mean|-24.2|||<|0.0001|TWO_SIDED|95.0|-30.3631|-18.1357|||Mixed Models Analysis|||||-18.1357|-30.3631|<.0001
71107852|NCT03012334|141721437|SUPERIORITY||LS Mean|-28.4|||<|0.0001|TWO_SIDED|95.0|-34.442|-22.2897|||Mixed Models Analysis|||||-22.2897|-34.4420|<.0001
71023115|NCT02033876|141553868|SUPERIORITY|||||||0.51|||||||ANCOVA|||||||0.51
71023116|NCT02033876|141553869|SUPERIORITY|||||||0.4|||||||ANCOVA|||||||0.4
71023117|NCT02033876|141553870|SUPERIORITY|||||||0.8|||||||ANCOVA|||||||0.8
71023118|NCT02033876|141553871|SUPERIORITY|||||||0.006|||||||ANCOVA|||||||0.006
71023119|NCT01360632|141553872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19||||0.0925|TWO_SIDED|95.0|-2.58|0.2|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||The primary analysis was performed on the Efficacy Sample by fitting a Mixed Model Repeated Measures (MMRM) analysis with an unstructured variance covariance structure in which the change from the end of Phase A (Week 8) in MADRS Total Score (at Weeks 9 to 14) was the dependent variable. The model included fixed class effect terms for treatment, trial site, visit week, and an interaction term of treatment by visit week.||0.2|-2.58|0.0925
70934064|NCT02434328|141368970|OTHER||Difference in proportions|-5.5|||||TWO_SIDED|95.0|-10.3|-0.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-0.4|-10.3|
70934065|NCT02434328|141368970|OTHER||Difference in proportions|-6.0|||||TWO_SIDED|95.0|-11.2|-0.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-0.5|-11.2|
71107853|NCT03012334|141721437|SUPERIORITY||LS Mean|-30.4|||<|0.0001|TWO_SIDED|95.0|-36.5068|-24.277|||Mixed Models Analysis|||||-24.2770|-36.5068|<0.0001
71107854|NCT03012334|141721437|SUPERIORITY||LS Mean|17.8|||<|0.0001|TWO_SIDED|95.0|11.7029|23.8908|||Mixed Models Analysis|||||23.8908|11.7029|<.0001
71107855|NCT03012334|141721437|SUPERIORITY||LS Mean|6.1||||0.0489|TWO_SIDED|95.0|0.0297|12.2554|||Mixed Models Analysis|||||12.2554|0.0297|0.0489
71107856|NCT03012334|141721437|SUPERIORITY||LS Mean|2.0||||0.5123|TWO_SIDED|95.0|-4.05|8.1021|||Mixed Models Analysis|||||8.1021|-4.0500|0.5123
71107857|NCT03012334|141721437|SUPERIORITY||LS Mean|-26.4|||<|0.0001|TWO_SIDED|95.0|-32.4956|-20.3628|||Mixed Models Analysis|||||-20.3628|-32.4956|<.0001
71107858|NCT03012334|141721437|SUPERIORITY||LS Mean|-37.8|||<|0.0001|TWO_SIDED|95.0|-43.927|-31.7537|||Mixed Models Analysis|||||-31.7537|-43.9270|<.0001
70941669|NCT04748445|141383934|OTHER||Slope|2.386|STANDARD_ERROR_OF_MEAN|8.233||0.0044|TWO_SIDED|90.0|1.022|3.75|||Mixed Models Analysis|||MM\_MFCC std 05 (The statistical data given below have (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and estimated value it was 10\^-2. For dispersion value it was 10\^-3).||3.750|1.022|0.0044
71056624|NCT00447876|141617716|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.8|||=|0.8|TWO_SIDED|95.0|-6.8|5.3||The difference (most affected side - control side) in ROM for the dorsal extension was analyzed using a fixed effect ANCOVA, using Week 18 results as the dependent variable and baseline value as covariate.|ANCOVA|||||5.3|-6.8|=0.800
71056625|NCT00447876|141617717|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.862|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 2. The variables for global assessment of pain assessed by the Investigator were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.862
71056626|NCT00447876|141617717|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.317|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 6. The variables for global assessment of pain assessed by the Investigator were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.317
71056627|NCT00447876|141617717|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.525|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 10. The variables for global assessment of pain assessed by the Investigator were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.525
71056628|NCT00447876|141617717|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.931|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 14. The variables for global assessment of pain assessed by the Investigator were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.931
71056629|NCT00447876|141617717|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.353|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 18. The variables for global assessment of pain assessed by the Investigator were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.353
71056630|NCT00447876|141617718|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.882|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 2. The variables for global assessment of pain assessed by the patient were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.882
71056631|NCT00447876|141617718|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.489|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 6. The variables for global assessment of pain assessed by the patient were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.489
71056632|NCT00447876|141617718|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.66|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 10. The variables for global assessment of pain assessed by the patient were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.660
71056633|NCT00447876|141617718|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.485|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 14. The variables for global assessment of pain assessed by the patient were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.485
71056634|NCT00447876|141617718|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.392|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 18. The variables for global assessment of pain assessed by the patient were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.392
71056635|NCT01256944|141617735|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71056636|NCT01256944|141617736|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71056637|NCT01256944|141617737|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71056638|NCT01256944|141617739|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71056639|NCT01256944|141617740|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71056640|NCT01256944|141617741|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71056641|NCT01256944|141617742|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71056642|NCT01256944|141617744|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71056643|NCT01256944|141617745|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71056644|NCT02047734|141617755|SUPERIORITY||Rate Ratio|0.623|||<|0.0001|TWO_SIDED|95.0|0.506|0.768||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.025 level.|Poisson regression model|Adjusted for region, age, and Baseline number of GdE lesions, and Included the natural log transformation of time on study as an offset term.|Rate Ratio = Ozanimod / IFN β-1a|||0.768|0.506|<0.0001
71056645|NCT02047734|141617755|SUPERIORITY||Rate Ratio|0.791||||0.0167|TWO_SIDED|95.0|0.652|0.958||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.025 level.|Poisson Regression Model|Adjusted for region, age, and Baseline number of GdE lesions, and Included the natural log transformation of time on study as an offset term.|Rate Ratio = Ozanimod / IFN β-1a|||0.958|0.652|0.0167
71056646|NCT02047734|141617756|SUPERIORITY||Rate Ratio|0.576|||<|0.0001|TWO_SIDED|95.0|0.465|0.714||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Negative Binomial Regression Model|Adjusted for region, age, and Baseline GdE lesions, and included the natural log transformation of available number of MRI scans as an offset term.|Rate Ratio = Ozanimod / IFN β-1a|||0.714|0.465|<0.0001
71056647|NCT02047734|141617756|SUPERIORITY||Rate Ratio|0.657||||0.0001|TWO_SIDED|95.0|0.531|0.813||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Negative binomial regression model|Adjusted for region, age, and Baseline GdE lesions and included the natural log transformation of available number of MRI scans as an offset term.|Rate Ratio = Ozanimod / IFN β-1a|||0.813|0.531|0.0001
71107859|NCT03012334|141721437|SUPERIORITY||LS Mean|-46.8|||<|0.0001|TWO_SIDED|95.0|-52.8147|-40.7268|||Mixed Models Analysis|||||-40.7268|-52.8147|<.0001
70934066|NCT02434328|141368970|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-4.8|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||5.6|-4.8|
70934067|NCT02434328|141368970|OTHER||Difference in proportions|-9.1|||||TWO_SIDED|95.0|-13.8|-3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-3.9|-13.8|
70934068|NCT02434328|141368970|OTHER||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-7.1|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||3.5|-7.1|
71107860|NCT03012334|141721437|SUPERIORITY||LS Mean|-52.6|||<|0.0001|TWO_SIDED|95.0|-58.649|-46.4682|||Mixed Models Analysis|||||-46.4682|-58.6490|<0.0001
71107861|NCT03012334|141721437|SUPERIORITY||LS Mean|26.1|||<|0.0001|TWO_SIDED|95.0|20.0635|32.1953|||Mixed Models Analysis|||||32.1953|20.0635|<.0001
71107862|NCT03012334|141721437|SUPERIORITY||LS Mean|14.7|||<|0.0001|TWO_SIDED|95.0|8.6325|20.804|||Mixed Models Analysis|||||20.8040|8.6325|<.0001
71107863|NCT03012334|141721437|SUPERIORITY||LS Mean|5.8||||0.0605|TWO_SIDED|95.0|-0.256|11.8317|||Mixed Models Analysis|||||11.8317|-0.2560|0.0605
71107864|NCT03012334|141721438|SUPERIORITY||LS Mean|-4.5|||<|0.001|TWO_SIDED|95.0|-6.14|-2.85|||Mixed Models Analysis|||||-2.85|-6.14|<0.001
71107865|NCT03012334|141721438|SUPERIORITY||LS Mean|-6.9|||<|0.001|TWO_SIDED|95.0|-8.58|-5.28|||Mixed Models Analysis|||||-5.28|-8.58|<0.001
71107866|NCT03012334|141721438|SUPERIORITY||LS Mean|-8.9|||<|0.001|TWO_SIDED|95.0|-10.52|-7.23|||Mixed Models Analysis|||||-7.23|-10.52|<0.001
71107867|NCT03012334|141721438|SUPERIORITY||LS Mean|-11.2|||<|0.001|TWO_SIDED|95.0|-12.81|-9.51|||Mixed Models Analysis|||||-9.51|-12.81|<0.001
71056648|NCT02047734|141617757|SUPERIORITY||Rate Ratio|0.471||||0.0006|TWO_SIDED|95.0|0.306|0.725||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Negative Binomial Regression Model|Adjusted for region, age, and Baseline GdE lesions with the natural log transformation of available MRI scans at Month 24 as an offset term.|Rate ratio = Ozanimod / IFN β-1a|||0.725|0.306|0.0006
71056649|NCT02047734|141617757|SUPERIORITY||Rate Ratio|0.528||||0.003|TWO_SIDED|95.0|0.346|0.805||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Negative binomial regression model,|Adjusted for region, age, and Baseline GdE lesions with the natural log transformation of available MRI scans at Month 24 as an offset term.|Rate ratio = Ozanimod / IFN β-1a|||0.805|0.346|0.0030
71056650|NCT02047734|141617758|SUPERIORITY||Hazard Ratio (HR)|1.045||||0.8224|TWO_SIDED|95.0|0.711|1.537||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Cox proportional hazards model|Adjusted for region (Eastern Europe vs Rest of World) age at Baseline, and Baseline EDSS score|Hazard ratio (Ozanimod / IFN β-1a) based on Cox proportional hazard model with factors for treatment group, adjusted for region, age at Baseline, and Baseline EDSS score.|||1.537|0.711|0.8224
71056651|NCT02047734|141617758|SUPERIORITY||Hazard Ratio (HR)|0.798||||0.2849|TWO_SIDED|95.0|0.528|1.206||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Cox proportional hazards model|Adjusted for region (Eastern Europe vs Rest of World), age at Baseline, and Baseline EDSS score|Hazard ratio (Ozanimod / IFN β-1a) based on Cox proportional hazard model with factors for treatment group, adjusted for region, age at Baseline, and Baseline EDSS score.|||1.206|0.528|0.2849
71056652|NCT02047734|141617759|SUPERIORITY||Hazard Ratio (HR)|1.435||||0.1353|TWO_SIDED|95.0|0.893|2.305||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Cox proportional hazard model|Adjusted for region (Eastern Europe vs Rest of World), age at Baseline, and Baseline EDSS score|Hazard ratio (Ozanimod / IFN β-1a) based on Cox proportional hazard model with factors for treatment group, adjusted for region, age at Baseline, and Baseline EDSS score.|||2.305|0.893|0.1353
71056653|NCT02047734|141617759|SUPERIORITY||Hazard Ratio (HR)|1.098||||0.7154|TWO_SIDED|95.0|0.664|1.815||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Cox proportional hazard model|Adjusted for region (Eastern Europe vs Rest of World), age at Baseline, and Baseline EDSS score|Hazard ratio (Ozanimod / IFN β-1a) based on Cox proportional hazard model with factors for treatment group, adjusted for region, age at Baseline, and Baseline EDSS score.|||1.815|0.664|0.7154
71056654|NCT02047734|141617760|SUPERIORITY||Difference|9.4||||0.0047|TWO_SIDED|95.0|2.9|15.8|||Cochran-Mantel-Haenszel|Stratified by region (Eastern Europe vs Rest of the World) and Baseline EDSS category||||15.8|2.9|0.0047
71056655|NCT02047734|141617760|SUPERIORITY||Difference|7.1||||0.032|TWO_SIDED|95.0|0.6|13.6|||Cochran-Mantel-Haenszel|Stratified by region (Eastern Europe vs Rest of the World) and Baseline EDSS category||||13.6|0.6|0.0320
71107868|NCT03012334|141721438|SUPERIORITY||LS Mean|6.7|||<|0.001|TWO_SIDED|95.0|5.02|8.31|||Mixed Models Analysis|||||8.31|5.02|<0.001
71107869|NCT03012334|141721438|SUPERIORITY||LS Mean|4.2|||<|0.001|TWO_SIDED|95.0|2.58|5.88|||Mixed Models Analysis|||||5.88|2.58|<0.001
71056656|NCT02047734|141617761|SUPERIORITY||Difference|5.4||||0.0466|TWO_SIDED|95.0|0.0|10.8|||Cochran-Mantel-Haenszel|Based on the Cochran-Mantel-Haenszel test stratified by region (Eastern Europe vs. rest of the world) and Baseline EDSS category||||10.8|0.0|0.0466
71056657|NCT02047734|141617761|SUPERIORITY||Difference|5.1||||0.0581|TWO_SIDED|95.0|-0.3|10.5|||Cochran-Mantel-Haenszel|Based on the Cochran-Mantel-Haenszel test stratified by region (Eastern Europe vs. rest of the world) and Baseline EDSS category||||10.5|-0.3|0.0581
71056658|NCT02047734|141617762|SUPERIORITY||Difference in means|0.244|||<|0.0001|TWO_SIDED|95.0|0.125|0.363||Based on the analysis of covariance model, adjusted for region (Eastern Europe vs. rest of the world), Baseline EDSS category, and brain volume at Baseline|ANCOVA||Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs. rest of the world), Baseline EDSS category, and brain volume at Baseline.|||0.363|0.125|<0.0001
71056659|NCT02047734|141617762|SUPERIORITY||Difference in means|0.224||||0.0002|TWO_SIDED|95.0|0.106|0.342||Based on the analysis of covariance model, adjusted for region (Eastern Europe vs. rest of the world), Baseline EDSS category, and brain volume at Baseline.|ANCOVA||Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs. rest of the world), Baseline EDSS category, and brain volume at Baseline.|||0.342|0.106|0.0002
71056660|NCT02047734|141617763|SUPERIORITY||Difference in means|0.043||||0.248|TWO_SIDED|95.0|-0.03|0.116|||ANCOVA|Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and Baseline MSFC Z-score|Difference in means are based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and the Baseline MSFC Z-score.|||0.116|-0.030|0.2480
71107870|NCT03012334|141721438|SUPERIORITY||LS Mean|2.3|||<|0.007|TWO_SIDED|95.0|0.64|3.93|||Mixed Models Analysis|||||3.93|0.64|<0.007
71107871|NCT03012334|141721439|SUPERIORITY||LS Mean|1.439|||<|0.0001|TWO_SIDED|95.0|1.2198|1.6583|||Mixed Models Analysis|||||1.6583|1.2198|<0.0001
71107872|NCT03012334|141721439|SUPERIORITY||LS Mean|2.018|||<|0.0001|TWO_SIDED|95.0|1.7981|2.238|||Mixed Models Analysis|||||2.2380|1.7981|<0.0001
71107873|NCT03012334|141721439|SUPERIORITY||LS Mean|2.572|||<|0.0001|TWO_SIDED|95.0|2.3536|2.7909|||Mixed Models Analysis|||||2.7909|2.3536|<0.0001
71107874|NCT03012334|141721439|SUPERIORITY||LS Mean|2.553|||<|0.0001|TWO_SIDED|95.0|2.3331|2.773|||Mixed Models Analysis|||||2.7730|2.3331|<0.0001
71107875|NCT03012334|141721439|SUPERIORITY||LS Mean|-1.114|||<|0.0001|TWO_SIDED|95.0|-1.3333|-0.8948|||Mixed Models Analysis|||||-0.8948|-1.3333|<0.0001
71056661|NCT02047734|141617763|SUPERIORITY||Difference in means|0.093||||0.0123|TWO_SIDED|95.0|0.02|0.165|||ANCOVA|Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and Baseline MSFC Z-score|Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and the Baseline MSFC Z-score.|||0.165|0.020|0.0123
71056662|NCT02047734|141617764|SUPERIORITY||Difference in means|1.345||||0.0988|TWO_SIDED|95.0|-0.252|2.943|||ANCOVA|Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and Baseline summary score|Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and Baseline summary score.|Analysis of Physical Health Composite Summary Score||2.943|-0.252|0.0988
71056663|NCT02047734|141617764|SUPERIORITY||Difference in means|1.849||||0.0228|TWO_SIDED|95.0|0.258|3.44|||ANCOVA|Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and Baseline summary score.|Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and Baseline summary score.|Analysis of Physical Health Composite Summary Score||3.440|0.258|0.0228
71056664|NCT02047734|141617764|SUPERIORITY||Difference in means|0.38||||0.6997|TWO_SIDED|95.0|-1.553|2.313|||ANCOVA|Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and Baseline summary score|Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and Baseline summary score.|Analysis of Mental Health Composite Summary Score||2.313|-1.553|0.6997
71056665|NCT02047734|141617764|SUPERIORITY||Difference in means|0.587||||0.5501|TWO_SIDED|95.0|-1.339|2.513|||ANCOVA|Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and the Baseline summary score|Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and Baseline summary score.|Analysis of Mental Health Composite Summary Score||2.513|-1.339|0.5501
71056666|NCT02047734|141617766|SUPERIORITY||||||<|0.0001|||||||Rank ANCOVA|Adjusted for region and Baseline EDSS category, with the dependent variable as the residual of the rank of brain volume at Baseline||||||<0.0001
71056667|NCT02047734|141617766|SUPERIORITY||||||<|0.0001|||||||Rank ANCOVA|Adjusted for region and Baseline EDSS category, with the dependent variable as the residual of the rank of brain volume at Baseline||||||<0.0001
71056668|NCT02952586|141617776|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.9199|TWO_SIDED|95.0|0.928|1.573||The treatment arms were compared using a stratified, 1-sided, log rank Test. The three stratification factors were tumor (T) stage (\< T4 vs T4), Nodal (N) stage (N0 /N1/N2a/N2b vs N2c/N3), Human papillomavirus (HPV) status (Positive vs Negative).|Log Rank|||||1.573|0.928|0.9199
71056669|NCT02952586|141617777|SUPERIORITY||Hazard Ratio (HR)|1.31||||0.9372|TWO_SIDED|95.0|0.927|1.849||The treatment arms were compared using a stratified, 1-sided, log rank Test. The three stratification factors were tumor (T) stage (\< T4 vs T4), Nodal (N) stage (N0 /N1/N2a/N2b vs N2c/N3), Human papillomavirus (HPV) status (Positive vs Negative).|Log Rank|||||1.849|0.927|0.9372
71056670|NCT02952586|141617779|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.9316|TWO_SIDED|95.0|0.93|1.694||The treatment arms were compared using a stratified, 1-sided, log rank Test. The three stratification factors were tumor (T) stage (\< T4 vs T4), Nodal (N) stage (N0 /N1/N2a/N2b vs N2c/N3), Human papillomavirus (HPV) status (Positive vs Negative).|Log Rank|||||1.694|0.930|0.9316
71056671|NCT02952586|141617780|SUPERIORITY||Odds Ratio (OR)|0.947||||0.6229|TWO_SIDED|95.0|0.663|1.352||The treatment arms were compared using a stratified, 1-sided, Cochran-Mantel-Haenszel Test. The 3 stratification factors were tumor stage (\< T4 vs T4), Nodal stage (N0 /N1/N2a/N2b vs N2c/N3), HPV status (Positive vs Negative).|Cochran-Mantel-Haenszel|||||1.352|0.663|0.6229
71056672|NCT02952586|141617781|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.9061|TWO_SIDED|95.0|0.909|1.624||The treatment arms were compared using a stratified, 1-sided, log rank Test. The three stratification factors were tumor stage (\< T4 vs T4), Nodal stage (N0 /N1/N2a/N2b vs N2c/N3), HPV status (Positive vs Negative).|Log Rank|||||1.624|0.909|0.9061
71056673|NCT00789035|141617805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.74|-0.29||No formal testing so adjustment for multiple comparisons was not necessary.|ANCOVA|Based on ANCOVA with terms for baseline, treatment, number of previous anti-diabetic medications and country.|Difference calculated as empa 5mg minus placebo|||-0.29|-0.74|<0.0001
71056674|NCT00789035|141617805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.8|-0.35||No formal testing so adjustment for multiple comparisons was not necessary.|ANCOVA|Based on ANCOVA with terms for baseline, treatment, number of previous anti-diabetic medications and country.|Difference calculated as empa 10mg minus placebo|||-0.35|-0.80|<0.0001
71107876|NCT03012334|141721439|SUPERIORITY||LS Mean|-0.535|||<|0.0001|TWO_SIDED|95.0|-0.7549|-0.3151|||Mixed Models Analysis|||||-0.3151|-0.7549|<0.0001
71107877|NCT03012334|141721439|SUPERIORITY||LS Mean|0.019||||0.8629|TWO_SIDED|95.0|-0.1995|0.2379|||Mixed Models Analysis|||||0.2379|-0.1995|0.8629
71107878|NCT03012334|141721441|SUPERIORITY||LS Mean|0.18||||0.0002|TWO_SIDED|95.0|0.0849|0.2746|||Mixed Models Analysis|||||0.2746|0.0849|0.0002
71107879|NCT03012334|141721441|SUPERIORITY||LS Mean|0.303|||<|0.0001|TWO_SIDED|95.0|0.2082|0.3985|||Mixed Models Analysis|||||0.3985|0.2082|<.0001
71107880|NCT03012334|141721441|SUPERIORITY||LS Mean|0.372|||<|0.0001|TWO_SIDED|95.0|0.277|0.4662|||Mixed Models Analysis|||||0.4662|0.2770|<.0001
71107881|NCT03012334|141721441|SUPERIORITY||LS Mean|0.603|||<|0.0001|TWO_SIDED|95.0|0.508|0.6983|||Mixed Models Analysis|||||0.6983|0.5080|<.0001
71107882|NCT03012334|141721441|SUPERIORITY||LS Mean|-0.423|||<|0.0001|TWO_SIDED|95.0|-0.5183|-0.3286|||Mixed Models Analysis|||||-0.3286|-0.5183|<.0001
71107883|NCT03012334|141721441|SUPERIORITY||LS Mean|-0.3|||<|0.0001|TWO_SIDED|95.0|-0.3949|-0.2047|||Mixed Models Analysis|||||-0.2047|-0.3949|<0.0001
70934069|NCT02434328|141368970|OTHER||Difference in proportions|-5.2|||||TWO_SIDED|95.0|-11.1|0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||0.1|-11.1|
71056675|NCT00789035|141617805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.94|-0.5||No formal testing so adjustment for multiple comparisons was not necessary.|ANCOVA|Based on ANCOVA with terms for baseline, treatment, number of previous anti-diabetic medications and country.|Difference calculated as empa 25mg minus placebo|||-0.50|-0.94|<0.0001
71056676|NCT00719615|141617821|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||Only risk factors significant at the 0.10 level in univariate analysis were included in the multivariate model.|Fisher Exact|||Patient characteristics for each group were assessed using descriptive statistics, including medians, range, frequencies, and proportions. Categorical outcomes were compared between the 3 groups using a Fisher's exact test. A logistic regression modeling procedure was used to compare the odds of a low vitamin D levels between patient groups while adjusting for other risk factors: gender, age, BMI, season, and TNM staging.||||<0.05
71056677|NCT00345943|141617837|OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.03|TWO_SIDED||||||Mixed Models Analysis|Growth curve models with between-within degrees of freedom and a random effect for the intercept and fixed effects for predictors.|BN versus HC group effect|Growth curve models examined the following: group (BN versus HC) differences in cortical thickness (CT) at baseline; group differences in the rate of change in CT over time; and the persistence of group differences in CT over time.||||.03
71056678|NCT00345943|141617837|OTHER||Slope|0.053|STANDARD_ERROR_OF_MEAN|0.047|<|0.05|TWO_SIDED|95.0|-0.04|0.15|||Mixed Models Analysis|Growth curve models with between-within degrees of freedom and a random effect for the intercept and fixed effects for predictors.||Growth curve models examined the following: group (BN versus HC) differences in conflict-related BOLD signal at baseline; group differences in the rate of change in conflict-related BOLD signal over time; and the persistence of group differences in conflict-related BOLD signal over time.||0.15|-0.04|<.05
71056679|NCT00789737|141617841|SUPERIORITY_OR_OTHER|||||||0.0369||95.0|||||ANCOVA|||least squares mean; 80% power to detect a 0.3% change||||0.0369
71056680|NCT00789737|141617842|SUPERIORITY_OR_OTHER|||||||0.0373||95.0|||||ANCOVA|||||||0.0373
71056681|NCT00789737|141617847|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0|||||ANCOVA|||||||<0.00001
71056682|NCT00384930|141617854|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline. Change = Endpoint minus Baseline.|Permutation Test|||This is the principal inferential analysis of the primary outcome.||||<0.001
71056683|NCT00384930|141617855|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57||||0.025||95.0|-1.08|-0.07||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||-0.07|-1.08|0.025
71056684|NCT00384930|141617855|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|||<|0.001||95.0|-1.4|-0.4||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||-0.40|-1.40|<0.001
71056685|NCT00384930|141617855|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.96|||<|0.001||95.0|-1.45|-0.46||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||-0.46|-1.45|<0.001
71056686|NCT00384930|141617855|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.07|||<|0.001||95.0|-1.58|-0.57||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||-0.57|-1.58|<0.001
71056687|NCT00384930|141617856|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.97||||0.008||95.0|-1.69|-0.26||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||-0.26|-1.69|0.008
71056688|NCT00384930|141617856|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.69|||<|0.001||95.0|-2.4|-0.98||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||-0.98|-2.40|<0.001
71056689|NCT00384930|141617856|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.89|||<|0.001||95.0|-2.6|-1.18||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||-1.18|-2.60|<0.001
71107884|NCT03012334|141721441|SUPERIORITY||LS Mean|-0.232|||<|0.0001|TWO_SIDED|95.0|-0.3261|-0.137|||Mixed Models Analysis|||||-0.1370|-0.3261|<0.0001
71107885|NCT02286895|141721452|NON_INFERIORITY|The protocol stated that non-inferiority would be achieved if the lower limit of the 95% confidence interval (2-sided) for the difference in sero-conversion percentages (group receiving rotavirus minus group not receiving rotavirus) was \> -10%.|Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-4.0|4.2||||||Based on results from a prior study, the sponsor assumed 90% sero-conversion rates in each Arms A and B for each antigen in the two co-primary objectives. To rule out a non-inferiority margin of no more than 10% with 95% power (95% power was chosen to give an overall power of at least 90%) and a one-sided type-one error rate of no more than 2.5%, 237 evaluable subjects were required in each group to explore the co-primary objectives.||4.2|-4.0|
70934070|NCT02434328|141368970|OTHER||Difference in proportions|-5.6|||||TWO_SIDED|95.0|-10.9|-0.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||-0.5|-10.9|
70934071|NCT02434328|141368970|OTHER||Difference in proportions|-5.1|||||TWO_SIDED|95.0|-10.9|0.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||0.6|-10.9|
70934072|NCT02434328|141368970|OTHER||Difference in proportions|-5.2|||||TWO_SIDED|95.0|-11.0|-0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||-0.1|-11.0|
70934073|NCT02434328|141368970|OTHER||Difference in proportions|-6.9|||||TWO_SIDED|95.0|-12.5|-1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-1.2|-12.5|
71023120|NCT01360632|141553872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.52||||0.0327|TWO_SIDED|95.0|-2.92|-0.13|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||The primary analysis was performed on the Efficacy Sample by fitting a MMRM analysis with an unstructured variance covariance structure in which the change from the end of Phase A (Week 8) in MADRS Total Score (at Weeks 9 to 14) was the dependent variable. The model included fixed class effect terms for treatment, trial site, visit week, and an interaction term of treatment by visit week.||-0.13|-2.92|0.0327
71023121|NCT01360632|141553873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.0737|TWO_SIDED|95.0|-2.73|0.13|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.13|-2.73|0.0737
71023122|NCT01360632|141553873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.95||||0.0079|TWO_SIDED|95.0|-3.39|-0.51|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.51|-3.39|0.0079
71107886|NCT02286895|141721453|NON_INFERIORITY|The protocol stated that non-inferiority would be achieved if the lower limit of the 95% CI (2-sided) for the difference in sero-conversion percentages (group receiving rotavirus minus group not receiving rotavirus) was \> -10%.|Mean Difference (Net)|-4.1|||||TWO_SIDED|95.0|-12.2|4.0||||||Based on results from a prior study completed by PATH and CVD-Mali, the sponsor assumed 90% sero-conversion rates in each Arms A and B for each antigen in the two co-primary objectives. To rule out a non-inferiority margin of no more than 10% with 95% power (95% power was chosen to give an overall power of at least 90%) and a one-sided type-one error rate of no more than 2.5%, 237 evaluable subjects were required in each group to explore the co-primary objectives.||4.0|-12.2|
71107887|NCT02286895|141721454|NON_INFERIORITY|The protocol stated that non-inferiority would be achieved if the lower limit of the 95% confidence interval (2-sided) for the difference in sero-conversion percentages (group receiving rotavirus minus group not receiving rotavirus) was \> -10%.|Mean Difference (Net)|-2.4|||||TWO_SIDED|95.0|-7.5|2.7||||||Based on results from a prior study completed by PATH and CVD-Mali, the sponsor assumed 90% sero-conversion rates in each Arms A and B for each antigen in the two co-primary objectives. To rule out a non-inferiority margin of no more than 10% with 95% power (95% power was chosen to give an overall power of at least 90%) and a one-sided type-one error rate of no more than 2.5%, 237 evaluable subjects were required in each group to explore the co-primary objectives.||2.7|-7.5|
71107888|NCT02286895|141721455|EQUIVALENCE|Definition of equivalence/null hypothesis: geometric mean titer (GMT) of group receiving rotavirus vaccine divided by GMT of group not receiving rotavirus vaccine = 1.|geometric mean titer ratio|0.9|||||TWO_SIDED|95.0|0.8|1.1||||||||1.1|0.8|
71107889|NCT02286895|141721456|EQUIVALENCE|Definition of equivalence/null hypothesis: geometric mean concentration (GMC) of group receiving rotavirus vaccine/ GMC of group not receiving rotavirus vaccine = 1|geometric mean titer ratio|-0.7|||||TWO_SIDED|95.0|-5.2|3.8||||||||3.8|-5.2|
70934074|NCT02434328|141368970|OTHER||Difference in proportions|-5.5|||||TWO_SIDED|95.0|-10.7|-0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||-0.3|-10.7|
71107890|NCT02286895|141721457|EQUIVALENCE|Definition of equivalence/null hypothesis: geometric mean titer (GMT) of group receiving rotavirus vaccine divided by GMT of group not receiving rotavirus vaccine = 1.|geometric mean titer ratio|0.9|||||TWO_SIDED|95.0|0.7|1.3||||||||1.3|0.7|
71107891|NCT02286895|141721458|SUPERIORITY||Mean Difference (Net)|17.5|||||TWO_SIDED|95.0|9.7|25.3||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.||25.3|9.7|
71107892|NCT02286895|141721459|SUPERIORITY||Mean Difference (Net)|15.8|||||TWO_SIDED|95.0|8.1|23.4||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.||23.4|8.1|
71107893|NCT02286895|141721460|SUPERIORITY||Mean Difference (Net)|25.4|||||TWO_SIDED|95.0|14.6|36.2||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.||36.2|14.6|
70934075|NCT02434328|141368970|OTHER||Difference in proportions|-6.5|||||TWO_SIDED|95.0|-12.4|-0.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||-0.9|-12.4|
70934076|NCT02434328|141368970|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-7.0|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.4|-7.0|
70934077|NCT02434328|141368970|OTHER||Difference in proportions|-4.8|||||TWO_SIDED|95.0|-10.5|1.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||1.3|-10.5|
71023123|NCT01360632|141553874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.06||||0.0096|TWO_SIDED|95.0|-1.86|-0.26|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.26|-1.86|0.0096
71023124|NCT01360632|141553874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.4137|TWO_SIDED|95.0|-1.14|0.47|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.47|-1.14|0.4137
71107894|NCT02286895|141721461|SUPERIORITY||Mean Difference (Net)|31.1|||||TWO_SIDED|95.0|23.1|39.0||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.||39.0|23.1|
71107895|NCT02286895|141721462|SUPERIORITY||Mean Difference (Net)|17.7|||||TWO_SIDED|95.0|12.0|23.5||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.||23.5|12.0|
71107896|NCT02286895|141721463|SUPERIORITY||Mean Difference (Net)|52.0|||||TWO_SIDED|95.0|37.7|66.3||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.||66.3|37.7|
70934078|NCT02434328|141368970|OTHER||Difference in proportions|-5.6|||||TWO_SIDED|95.0|-11.4|0.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||0.5|-11.4|
70934079|NCT02434328|141368970|OTHER||Difference in proportions|-5.9|||||TWO_SIDED|95.0|-11.5|-0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||-0.3|-11.5|
71023125|NCT01360632|141553874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.44||||0.0065|TWO_SIDED|95.0|-2.47|-0.4|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate||Statistical analysis at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.4|-2.47|0.0065
71023126|NCT01360632|141553874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89||||0.0914|TWO_SIDED|95.0|-1.93|0.14|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.14|-1.93|0.0914
71023127|NCT01360632|141553874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39||||0.0139|TWO_SIDED|95.0|-2.5|-0.28|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.28|-2.5|0.0139
71107897|NCT02286895|141721464|SUPERIORITY||geometric mean titer ratio|1.7|||||TWO_SIDED|95.0|1.2|2.4||||||Null hypothesis: geometric mean titer (GMT) in group receiving rotavirus vaccine/GMT in group not receiving rotavirus vaccine ≤ 1||2.4|1.2|
71107898|NCT02286895|141721465|SUPERIORITY||geometric mean titer ratio|2.3|||||TWO_SIDED|95.0|1.7|3.1||||||Null hypothesis: 28 days post-vaccination, geometric mean titer (GMT) in group receiving rotavirus vaccine/GMT in group not receiving rotavirus vaccine ≤ 1||3.1|1.7|
70934080|NCT02434328|141368971|OTHER||Difference in proportions|-6.9|||||TWO_SIDED|95.0|-14.2|0.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||0.2|-14.2|
71107899|NCT02286895|141721466|SUPERIORITY||geometric mean titer ratio|2.0|||||TWO_SIDED|95.0|1.2|3.3||||||Null hypothesis: geometric mean titer (GMT) in group receiving rotavirus vaccine/GMT in group not receiving rotavirus vaccine ≤ 1||3.3|1.2|
71023128|NCT01360632|141553874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.2097|TWO_SIDED|95.0|-1.82|0.4|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.4|-1.82|0.2097
71023129|NCT01360632|141553874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.56||||0.0099|TWO_SIDED|95.0|-2.75|-0.38|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.38|-2.75|0.0099
71023130|NCT01360632|141553874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29||||0.034|TWO_SIDED|95.0|-2.48|-0.1|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.1|-2.48|0.034
71023131|NCT01360632|141553874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.53||||0.0177|TWO_SIDED|95.0|-2.8|-0.27|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.27|-2.8|0.0177
71023132|NCT01360632|141553874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71||||0.0085|TWO_SIDED|95.0|-2.98|-0.44|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.44|-2.98|0.0085
71023133|NCT01360632|141553875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||0.0286|TWO_SIDED|95.0|-1.74|-0.1|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.1|-1.74|0.0286
71023134|NCT01360632|141553875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.3173|TWO_SIDED|95.0|-1.24|0.4|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.4|-1.24|0.3173
71023135|NCT01360632|141553875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17||||0.0313|TWO_SIDED|95.0|-2.23|-0.11|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.11|-2.23|0.0313
71023136|NCT01360632|141553875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97||||0.0732|TWO_SIDED|95.0|-2.04|0.09|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.09|-2.04|0.0732
71056690|NCT00384930|141617856|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.87|||<|0.001||95.0|-2.59|-1.15||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||-1.15|-2.59|<0.001
71056691|NCT00384930|141617857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.503||95.0|-0.28|0.14||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||0.14|-0.28|0.503
71056692|NCT00384930|141617857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.206||95.0|-0.34|0.07||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||0.07|-0.34|0.206
71056693|NCT00384930|141617857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.452||95.0|-0.28|0.13||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||0.13|-0.28|0.452
71056694|NCT00384930|141617857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26||||0.012||95.0|-0.47|-0.06||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||-0.06|-0.47|0.012
71056695|NCT00384930|141617858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26||||0.029||95.0|-0.49|-0.03||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||-0.03|-0.49|0.029
70934081|NCT02434328|141368971|OTHER||Difference in proportions|-9.2|||||TWO_SIDED|95.0|-15.5|-2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||-2.5|-15.5|
70934082|NCT02434328|141368971|OTHER||Difference in proportions|-8.7|||||TWO_SIDED|95.0|-15.0|-2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-2.6|-15.0|
70934083|NCT02434328|141368971|OTHER||Difference in proportions|-15.7|||||TWO_SIDED|95.0|-22.9|-9.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-9.0|-22.9|
71023137|NCT01360632|141553875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36||||0.0206|TWO_SIDED|95.0|-2.51|-0.21|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.21|-2.51|0.0206
71023138|NCT01360632|141553875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91||||0.1233|TWO_SIDED|95.0|-2.06|0.25|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.25|-2.06|0.1233
71023139|NCT01360632|141553875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.61||||0.0097|TWO_SIDED|95.0|-2.84|-0.39|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.39|-2.84|0.0097
71023140|NCT01360632|141553875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63||||0.0092|TWO_SIDED|95.0|-2.86|-0.41|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.41|-2.86|0.0092
71023141|NCT01360632|141553875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63||||0.0139|TWO_SIDED|95.0|-2.94|-0.33|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.33|-2.94|0.0139
71023142|NCT01360632|141553875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.12||||0.0015|TWO_SIDED|95.0|-3.42|-0.81|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.81|-3.42|0.0015
71023143|NCT01360632|141553876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0008|TWO_SIDED|95.0|-0.87|-0.23||MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.23|-0.87|0.0008
70934084|NCT02434328|141368971|OTHER||Difference in proportions|7.7|||||TWO_SIDED|95.0|0.9|14.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||14.8|0.9|
71023144|NCT01360632|141553876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.5792|TWO_SIDED|95.0|-0.41|0.23||MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B||0.23|-0.41|0.5792
71023145|NCT01360632|141553876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0091|TWO_SIDED|95.0|-0.87|-0.12|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.12|-0.87|0.0091
71107900|NCT02286895|141721467|SUPERIORITY||geometric mean titer ratio|4.6|||||TWO_SIDED|95.0|2.4|8.9||||||Null hypothesis: geometric mean titer (GMT) in group receiving rotavirus vaccine/GMT in group not receiving rotavirus vaccine ≤ 1||8.9|2.4|
71107901|NCT01073293|141721471|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.95|||<|0.001|TWO_SIDED|95.0|0.86|1.05|||ANOVA|||Anti-HPV 6||1.05|0.86|<0.001
71107902|NCT01073293|141721471|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.97|||<|0.001|TWO_SIDED|95.0|0.87|1.07|||ANOVA|||Anti-HPV 11||1.07|0.87|<0.001
71107903|NCT01073293|141721471|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.94|||<|0.001|TWO_SIDED|95.0|0.85|1.04|||ANOVA|||Anti-HPV 16||1.04|0.85|<0.001
71107904|NCT01073293|141721471|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.95|||<|0.001|TWO_SIDED|95.0|0.84|1.07|||ANOVA|||Anti-HPV 18||1.07|0.84|<0.001
71107905|NCT01073293|141721471|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.94|||<|0.001|TWO_SIDED|95.0|0.84|1.06|||ANOVA|||Anti-HPV 31||1.06|0.84|<0.001
71107906|NCT01073293|141721471|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.9|||<|0.001|TWO_SIDED|95.0|0.81|1.0|||ANOVA|||Anti-HPV 33||1.00|0.81|<0.001
71107907|NCT01073293|141721471|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.97|||<|0.001|TWO_SIDED|95.0|0.86|1.11|||ANOVA|||Anti-HPV 45||1.11|0.86|<0.001
71107908|NCT01073293|141721471|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.95|||<|0.001|TWO_SIDED|95.0|0.85|1.06|||ANOVA|||Anti-HPV 52||1.06|0.85|<0.001
71107909|NCT01073293|141721471|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.89|||<|0.001|TWO_SIDED|95.0|0.8|0.99|||ANOVA|||Anti-HPV 58||0.99|0.80|<0.001
71107910|NCT01073293|141721476|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the percentage difference is greater than -10|Difference in percentage|0.2|||<|0.001|TWO_SIDED|95.0|-0.7|1.4|||Miettinen and Nurminen|||Anti-diphtheria titer \>=0.1 IU/mL||1.4|-0.7|<0.001
71107911|NCT01073293|141721476|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the percentage difference is greater than -10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-1.1|1.2|||Miettinen and Nurminen|||Anti-tetanus titer \>=0.1 IU/mL||1.2|-1.1|<0.001
71107912|NCT01073293|141721477|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.67|Fold difference in GMT|0.95|||<|0.001|TWO_SIDED|95.0|0.85|1.06|||ANOVA|||Anti-PT||1.06|0.85|<0.001
71107913|NCT01073293|141721477|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.67|Fold difference in GMT|0.99|||<|0.001|TWO_SIDED|95.0|0.9|1.08|||ANOVA|||Anti-FHA||1.08|0.90|<0.001
71107914|NCT01073293|141721477|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.67|Difference in GMT|0.94|||<|0.001|TWO_SIDED|95.0|0.8|1.09|||ANOVA|||Anti-PRN||1.09|0.80|<0.001
71107915|NCT01073293|141721477|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.67|Difference in GMT|0.89||||0.005|TWO_SIDED|95.0|0.72|1.11|||ANOVA|||Anti-FIM 2/3||1.11|0.72|0.005
71107916|NCT01073293|141721478|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the difference is statistically less than 10 percentage points|Difference in percentage|-0.2|||<|0.001|TWO_SIDED|95.0|-1.2|0.8|||Miettinen and Nurminen|||Poliovirus type 1||0.8|-1.2|<0.001
71107917|NCT01073293|141721478|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the difference is statistically less than 10 percentage points|Difference in percentage|-0.2|||<|0.001|TWO_SIDED|95.0|-1.2|0.8|||Miettinen and Nurminen|||Poliovirus type 2||0.8|-1.2|<0.001
70934085|NCT02434328|141368971|OTHER||Difference in proportions|-20.0|||||TWO_SIDED|95.0|-27.3|-13.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-13.1|-27.3|
71107918|NCT01073293|141721478|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the difference is statistically less than 10 percentage points|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-0.8|0.8|||Miettinen and Nurminen|||Poliovirus type 3||0.8|-0.8|<0.001
71107919|NCT00077974|141721507|SUPERIORITY_OR_OTHER||Percent|33.0||||||95.0|24.2|42.8|||||Using exact method based on binomial distribution. Percent equals n divided by N times 100.|||42.8|24.2|
71107920|NCT00256126|141721519|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71107921|NCT02949011|141721535|SUPERIORITY||Median Difference|-29.1|||<|0.0001|TWO_SIDED|95.0|-42.8|-14.6||Adjusted p-value, two-sided significance level of 0.05|Stratified generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||The primary analysis of the primary endpoint was a comparison between the baloxavir marboxil and placebo groups.||-14.6|-42.8|<0.0001
71107922|NCT02949011|141721535|SUPERIORITY||Median Difference|-7.7||||0.8347|TWO_SIDED|95.0|-22.7|7.9||Adjusted p-value, two-sided significance level of 0.05|Stratified generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||The comparison between the baloxavir marboxil and the oseltamivir groups was conducted as a secondary analysis only if a statistically significant difference was observed in the primary analysis in order to maintain control of overall type I error.||7.9|-22.7|0.8347
71107923|NCT02949011|141721535|SUPERIORITY|||||||0.0008||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Log Rank|Log rank test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Analysis using the stratified log rank test was performed as a sensitivity analysis.||||0.0008
70934086|NCT02434328|141368971|OTHER||Difference in proportions|-3.9|||||TWO_SIDED|95.0|-10.4|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.4|-10.4|
71023146|NCT01360632|141553876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.0474|TWO_SIDED|95.0|-0.73|0.0|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0|-0.73|0.0474
71107924|NCT02949011|141721535|SUPERIORITY|||||||0.8449||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Log Rank|Log rank test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Analysis using the stratified log rank test was performed as a sensitivity analysis.||||0.8449
71023147|NCT01360632|141553877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.0015|TWO_SIDED|95.0|-0.94|-0.22||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.22|-0.94|0.0015
71023148|NCT01360632|141553877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.2627|TWO_SIDED|95.0|-0.56|0.15||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate|Mixed Models Analysis|||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.15|-0.56|0.2627
71023149|NCT01360632|141553877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0158|TWO_SIDED|95.0|-0.89|-0.09|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3||-0.09|-0.89|0.0158
71023150|NCT01360632|141553877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.0191|TWO_SIDED|95.0|-0.88|-0.08|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.08|-0.88|0.0191
71023151|NCT01360632|141553878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.0377|TWO_SIDED|95.0|-0.88|-0.03|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Work/School: Week 11||-0.03|-0.88|0.0377
71023152|NCT01360632|141553878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.0741|TWO_SIDED|95.0|-0.91|0.04||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis||-0.43|For Item: Work/School: Week 14||0.04|-0.91|0.0741
71023153|NCT01360632|141553878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.0966|TWO_SIDED|95.0|-0.07|0.81||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||For Item: Work/School: Week 11||0.81|-0.07|0.0966
71023154|NCT01360632|141553878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.4774|TWO_SIDED|95.0|-0.66|0.31|||Mixed Models Analysis|||For Item: Work/School: Week 14||0.31|-0.66|0.4774
71023155|NCT01360632|141553878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.0263|TWO_SIDED|95.0|-0.76|-0.05||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Social life: Week 11||-0.05|-0.76|0.0263
71023156|NCT01360632|141553878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.0214|TWO_SIDED|95.0|-0.89|-0.07|||Mixed Models Analysis|||Social life: Week 14||-0.07|-0.89|0.0214
71023157|NCT01360632|141553878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.8281|TWO_SIDED|95.0|-0.4|0.32||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Social life: Week 11||0.32|-0.40|0.8281
71023158|NCT01360632|141553878|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.054|TWO_SIDED|95.0|-0.8|0.01|||Mixed Models Analysis|||Social life: Week 14||0.01|-0.80|0.0540
71023159|NCT01360632|141553878|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.63||||0.0008|TWO_SIDED|95.0|-0.99|-0.26||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Family life: Week 11||-0.26|-0.99|0.0008
71023160|NCT01360632|141553878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0093|TWO_SIDED|95.0|-0.97|-0.14|||Mixed Models Analysis|||Family life: Week 14||-0.14|-0.97|0.0093
71023161|NCT01360632|141553878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.2182|TWO_SIDED|95.0|-0.59|0.14|||Mixed Models Analysis|||Family life: Week 11||0.14|-0.59|0.2182
71023162|NCT01360632|141553878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.0256|TWO_SIDED|95.0|-0.9|-0.06||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Family life: Week 14||-0.06|-0.90|0.0256
71107925|NCT02949011|141721536|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||<0.0001
71107926|NCT02949011|141721536|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||<0.0001
71107927|NCT02949011|141721536|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||<0.0001
70934087|NCT02434328|141368971|OTHER||Difference in proportions|-9.7|||||TWO_SIDED|95.0|-16.7|-2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||-2.5|-16.7|
70934088|NCT02434328|141368971|OTHER||Difference in proportions|-9.4|||||TWO_SIDED|95.0|-15.8|-3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-3.4|-15.8|
71023163|NCT01360632|141553879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.0341|TWO_SIDED|95.0|-1.01|-0.04||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Work/school: Week 11||-0.04|-1.01|0.0341
71023164|NCT01360632|141553879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0816|TWO_SIDED|95.0|-0.99|0.06||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||School/work: Week 14||0.06|-0.99|0.0816
71023165|NCT01360632|141553879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.2561|TWO_SIDED|95.0|-0.21|0.78||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Work/school: Week 11||0.78|-0.21|0.2561
71056696|NCT00384930|141617858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.37||||0.002||95.0|-0.6|-0.14||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||-0.14|-0.60|0.002
71056697|NCT00384930|141617858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.43|||<|0.001||95.0|-0.66|-0.19||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||-0.19|-0.66|<0.001
71056698|NCT00384930|141617858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|||<|0.001||95.0|-0.64|-0.17||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||-0.17|-0.64|<0.001
71056699|NCT00384930|141617859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.583||95.0|-0.58|0.33||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||0.33|-0.58|0.583
71056700|NCT00384930|141617859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57||||0.013||95.0|-1.03|-0.12||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||-0.12|-1.03|0.013
71056701|NCT00384930|141617859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.55||||0.016||95.0|-1.0|-0.1||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||-0.10|-1.00|0.016
71056702|NCT00384930|141617859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.62||||0.007||95.0|-1.08|-0.17||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||-0.17|-1.08|0.007
71056703|NCT00384930|141617860|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||P-values are from Cochran-Mantel-Haenszel test stratified by the randomization strata factors (4 geographic regions, 2 levels of IPSS severity, 2 levels of ED history) as fixed effect, and were not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.133
71056704|NCT00384930|141617860|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-values are from Cochran-Mantel-Haenszel test stratified by the randomization strata factors (4 geographic regions, 2 levels of IPSS severity, 2 levels of ED history) as fixed effect, and were not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.003
71023166|NCT01360632|141553879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.2952|TWO_SIDED|95.0|-0.82|0.25||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Work/school: Week 14||0.25|-0.82|0.2952
71023167|NCT01360632|141553879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.0331|TWO_SIDED|95.0|-0.82|-0.03||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Social life: Week 11||-0.03|-0.82|0.0331
71023168|NCT01360632|141553879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.0352|TWO_SIDED|95.0|-0.9|-0.03|||Mixed Models Analysis|||Social life: Week 14||-0.03|-0.90|0.0352
71023169|NCT01360632|141553879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.486|TWO_SIDED|95.0|-0.54|0.25||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Social life: Week 11||0.25|-0.54|0.4860
71023170|NCT01360632|141553879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0282|TWO_SIDED|95.0|-0.93|-0.05||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Social life: Week 14||-0.05|-0.93|0.0282
70934089|NCT02434328|141368971|OTHER||Difference in proportions|-16.5|||||TWO_SIDED|95.0|-23.4|-9.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-9.6|-23.4|
70934090|NCT02434328|141368971|OTHER||Difference in proportions|3.4|||||TWO_SIDED|95.0|-3.3|10.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||10.4|-3.3|
71056705|NCT00384930|141617860|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from Cochran-Mantel-Haenszel test stratified by the randomization strata factors (4 geographic regions, 2 levels of IPSS severity, 2 levels of ED history) as fixed effect, and were not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|||||||<0.001
71056706|NCT00384930|141617860|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from Cochran-Mantel-Haenszel test stratified by the randomization strata factors (4 geographic regions, 2 levels of IPSS severity, 2 levels of ED history) as fixed effect, and were not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|||||||<0.001
70934091|NCT02434328|141368971|OTHER||Difference in proportions|-18.1|||||TWO_SIDED|95.0|-24.9|-11.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-11.8|-24.9|
70934092|NCT02434328|141368971|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-9.2|3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||3.2|-9.2|
71056707|NCT00384930|141617861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.14||||0.735||95.0|-0.69|0.98||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||0.98|-0.69|0.735
71056708|NCT00384930|141617861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.355||95.0|-0.44|1.23||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||1.23|-0.44|0.355
71056709|NCT00384930|141617861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.34||||0.433||95.0|-0.5|1.17||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||1.17|-0.50|0.433
71056710|NCT00384930|141617861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74||||0.089||95.0|-0.11|1.59||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||1.59|-0.11|0.089
71107928|NCT02949011|141721536|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||<0.0001
71107929|NCT02949011|141721536|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||<0.0001
71107930|NCT02949011|141721536|SUPERIORITY|||||||0.0044||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.0044
71056711|NCT00384930|141617862|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.36|||<|0.001||95.0|1.56|5.17||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||5.17|1.56|<0.001
71107931|NCT02949011|141721536|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||<0.0001
71107932|NCT02949011|141721536|SUPERIORITY|||||||0.1146||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.1146
70934093|NCT02434328|141368971|OTHER||Difference in proportions|-9.4|||||TWO_SIDED|95.0|-16.3|-2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||-2.8|-16.3|
70934094|NCT02434328|141368971|OTHER||Difference in proportions|-5.7|||||TWO_SIDED|95.0|-12.5|1.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||1.1|-12.5|
71107933|NCT02949011|141721536|SUPERIORITY|||||||0.0046||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.0046
71023171|NCT01360632|141553879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.0016|TWO_SIDED|95.0|-1.01|-0.24||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Family life: Week 11||-0.24|-1.01|0.0016
71107934|NCT02949011|141721536|SUPERIORITY|||||||0.441||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.441
70941670|NCT04748445|141383934|OTHER||Slope|1.593|STANDARD_ERROR_OF_MEAN|1.243||0.2022|TWO_SIDED|90.0|-4.663|3.652|||Mixed Models Analysis|||MM\_MFCC std 06 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-2. For lower limit it was 10\^-3).||3.652|-4.663|0.2022
71023172|NCT01360632|141553879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.0186|TWO_SIDED|95.0|-0.94|-0.09|||Mixed Models Analysis|||Family life: Week 14||-0.09|-0.94|0.0186
71023173|NCT01360632|141553879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0824|TWO_SIDED|95.0|-0.73|0.04||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Family life: Week 11||0.04|-0.73|0.0824
71023174|NCT01360632|141553879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59||||0.0077|TWO_SIDED|95.0|-1.02|-0.16||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Family life: Week 14||-0.16|-1.02|0.0077
71023175|NCT01360632|141553880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.0436|TWO_SIDED|95.0|-0.18|0.0|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0|-0.18|0.0436
71023176|NCT01360632|141553880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||-0.06|TWO_SIDED|95.0|-0.15|0.03|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.03|-0.15|-0.06
71023177|NCT01360632|141553880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.0012|TWO_SIDED|95.0|-0.34|-0.08|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.08|-0.34|0.0012
71023178|NCT01360632|141553880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.0266|TWO_SIDED|95.0|-0.27|-0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.02|-0.27|0.0266
71023179|NCT01360632|141553880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.0034|TWO_SIDED|95.0|-0.33|-0.07|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.07|-0.33|0.0034
71023180|NCT01360632|141553880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.3053|TWO_SIDED|95.0|-0.2|0.06|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.06|-0.2|0.3053
71023181|NCT01360632|141553880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.0541|TWO_SIDED|95.0|-0.29|0.0|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0|-0.29|0.0541
70934095|NCT02434328|141368971|OTHER||Difference in proportions|-15.5|||||TWO_SIDED|95.0|-21.9|-8.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-8.5|-21.9|
70934096|NCT02434328|141368971|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-5.9|7.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||7.5|-5.9|
70934097|NCT02434328|141368971|OTHER||Difference in proportions|-14.9|||||TWO_SIDED|95.0|-21.4|-8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-8.1|-21.4|
70934098|NCT02434328|141368971|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-7.5|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||5.4|-7.5|
70934099|NCT02434328|141368971|OTHER||Difference in proportions|-10.4|||||TWO_SIDED|95.0|-17.2|-3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||-3.4|-17.2|
70934100|NCT02434328|141368971|OTHER||Difference in proportions|-4.5|||||TWO_SIDED|95.0|-11.4|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||2.3|-11.4|
70934101|NCT02434328|141368971|OTHER||Difference in proportions|-11.0|||||TWO_SIDED|95.0|-18.2|-4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||-4.1|-18.2|
71056712|NCT00384930|141617862|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.75|||<|0.001||95.0|2.95|6.54||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||6.54|2.95|<0.001
71056713|NCT00384930|141617862|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.83|||<|0.001||95.0|4.04|7.62||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||7.62|4.04|<0.001
71056714|NCT00384930|141617862|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.15|||<|0.001||95.0|4.35|7.95||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||7.95|4.35|<0.001
70934102|NCT02434328|141368971|OTHER||Difference in proportions|-2.9|||||TWO_SIDED|95.0|-9.4|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||3.5|-9.4|
70934103|NCT02434328|141368971|OTHER||Difference in proportions|-14.1|||||TWO_SIDED|95.0|-21.3|-7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||-7.2|-21.3|
71056715|NCT00384930|141617863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.58||||0.005||95.0|-2.68|-0.48||P-values are from an ANCOVA model with effect of treatment group, geographic region, and IPSS baseline value (at Visit 3) as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|This is a supportive analysis of the primary outcome.||-0.48|-2.68|0.005
71056716|NCT00384930|141617863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6|||<|0.001||95.0|-3.69|-1.51||P-values are from an ANCOVA model with effect of treatment group, geographic region, and IPSS baseline value (at Visit 3) as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|This is a supportive analysis of the primary outcome.||-1.51|-3.69|<0.001
71107935|NCT02949011|141721536|SUPERIORITY|||||||0.0929||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.0929
71107936|NCT02949011|141721536|SUPERIORITY|||||||0.0907||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.0907
70934104|NCT02294461|141368985|SUPERIORITY_OR_OTHER_LEGACY||Unstratified Cox Proportional Hazards|0.38|||<|0.0001|TWO_SIDED|95.0|0.27|0.52|||Hazard Ratio|||P-value is based on an unstratified log-rank test. Hazard ratio calculated using unstratified Cox Proportional Hazards model with treatment as the only covariate for enzalutamide group versus placebo group.||0.52|0.27|<0.0001
71056717|NCT00384930|141617863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9|||<|0.001||95.0|-3.99|-1.81||P-values are from an ANCOVA model with effect of treatment group, geographic region, and IPSS baseline value (at Visit 3) as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|This is a supportive analysis of the primary outcome.||-1.81|-3.99|<0.001
71056718|NCT00384930|141617863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.94|||<|0.001||95.0|-4.04|-1.84||P-values are from an ANCOVA model with effect of treatment group, geographic region, and IPSS baseline value (at Visit 3) as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|This is a supportive analysis of the primary outcome.||-1.84|-4.04|<0.001
71056719|NCT02686138|141617864|SUPERIORITY||Risk Difference (RD)|12.85|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71056720|NCT02686138|141617865|SUPERIORITY||Risk Difference (RD)|14.11|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71056721|NCT02686138|141617866|SUPERIORITY||Risk Difference (RD)|11.5||||0.004|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.004
71056722|NCT02686138|141617867|SUPERIORITY||Risk Difference (RD)|11.16||||0.003|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.003
71056723|NCT02686138|141617868|SUPERIORITY||Risk Difference (RD)|10.3||||0.01|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.01
71056724|NCT02686138|141617869|SUPERIORITY||Risk Difference (RD)|10.17||||0.013|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.013
71056725|NCT02686138|141617870|SUPERIORITY||Risk Difference (RD)|13.1|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71056726|NCT02686138|141617871|SUPERIORITY||Risk Difference (RD)|16.18|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71056727|NCT02686138|141617872|SUPERIORITY||Risk Difference (RD)|9.17||||0.015|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.015
71056728|NCT03968978|141617894|OTHER||Proportion|98.2|||||TWO_SIDED|95.0|93.67|99.5|||Score CI|CI at Week 0 (in clinic)||||99.5|93.67|
71056729|NCT03968978|141617894|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.65|100.0|||Score CI|CI at Week 4 (in clinic)||||100|96.65|
71056730|NCT03968978|141617894|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.63|100.0|||Score CI|CI for Week 8 (in clinic)||||100.00|96.63|
71056731|NCT03968978|141617894|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.63|100.0|||Score CI|CI for Week 12 (at home)||||100.00|96.63|
71056732|NCT03968978|141617894|OTHER||Proportion|95.4|||||TWO_SIDED|95.0|89.71|98.02|||Score CI|CI for Week 16 (at home)||||98.02|89.71|
71056733|NCT03968978|141617894|OTHER||Proportion|96.3|||||TWO_SIDED|95.0|90.94|98.56|||Score CI|CI for Week 20 (in clinic)||||98.56|90.94|
71056734|NCT03968978|141617894|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.47|100.0|||Score CI|CI for Week 0 (in clinic)||||100.00|96.47|
71056735|NCT03968978|141617894|OTHER||Proportion|97.1|||||TWO_SIDED|95.0|91.93|99.02|||Score CI|CI for Week 4 (in clinic)||||99.02|91.93|
71056736|NCT03968978|141617894|OTHER||Proportion|98.1|||||TWO_SIDED|95.0|93.32|99.48|||Score CI|CI for Week 8 (in clinic)||||99.48|93.32|
71056737|NCT03968978|141617894|OTHER||Proportion|99.0|||||TWO_SIDED|95.0|94.8|99.83|||Score CI|CI for week 12 (at home)||||99.83|94.80|
71056738|NCT03968978|141617894|OTHER||Proportion|97.1|||||TWO_SIDED|95.0|91.93|99.02|||Score CI|CI for Week 16 (at home)||||99.02|91.93|
71056739|NCT03968978|141617894|OTHER||Proportion|97.1|||||TWO_SIDED|95.0|91.93|99.02|||Score CI|CI for Week 20 (in clinic)||||99.02|91.93|
71056740|NCT03968978|141617895|OTHER||Proportion|98.2|||||TWO_SIDED|95.0|93.67|99.5|||Score CI|CI at Week 0 (in clinic)||||99.50|93.67|
71056741|NCT03968978|141617895|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.65|100.0|||Score CI|CI at Week 4 (in clinic)||||100.00|96.65|
71056742|NCT03968978|141617895|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.63|100.0|||Score CI|CI for Week 8 (in clinic)||||100.00|96.63|
71056743|NCT03968978|141617895|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.63|100.0|||Score CI|CI for Week 12 (at home)||||100.00|96.63|
71056744|NCT03968978|141617895|OTHER||Proportion|97.2|||||TWO_SIDED|95.0|92.8|99.04|||Score CI|CI for Week 16 (at home)||||99.04|92.80|
71056745|NCT03968978|141617895|OTHER||Proportion|99.1|||||TWO_SIDED|95.0|94.85|99.83|||Score CI|CI for Week 20 (in clinic)||||99.83|94.85|
71056746|NCT03968978|141617895|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.46|100.0|||Score CI|CI for Week 0 (in clinic)||||100.00|96.46|
71056747|NCT03968978|141617895|OTHER||Proportion|97.2|||||TWO_SIDED|95.0|93.38|99.48|||Score CI|CI for Week 4 (in clinic)||||99.48|93.38|
71056748|NCT03968978|141617895|OTHER||Proportion|98.1|||||TWO_SIDED|95.0|93.32|99.48|||Other CI|CI for Week 8 (in clinic)||||99.48|93.32|
71056749|NCT03968978|141617895|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.44|100.0|||Score CI|CI for week 12 (at home)||||100.00|96.44|
71056750|NCT03968978|141617895|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.37|100.0|||Score CI|CI for Week 16 (at home)||||100.00|96.37|
71056751|NCT03968978|141617895|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.37|100.0|||Score CI|CI for Week 20 (in clinic)||||100.00|96.37|
71056752|NCT03968978|141617896|OTHER||Proportion|1.8|||||TWO_SIDED|95.0|0.5|6.33|||Score CI|CI at Week 0 (in clinic)||||6.33|0.50|
71056753|NCT03968978|141617896|OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.35|||Score CI|CI at Week 4 (in clinic)||||3.35|0|
71056754|NCT03968978|141617896|OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.37|||Score CI|CI for Week 8 (in clinic)||||3.37|0|
71056755|NCT03968978|141617896|OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.37|||Score CI|CI for Week 12 (at home)||||3.37|0|
71056756|NCT03968978|141617896|OTHER||Proportion|2.8|||||TWO_SIDED|95.0|0.96|7.92|||Score CI|CI for Week 16 (at home)||||7.92|0.96|
71056757|NCT03968978|141617896|OTHER||Proportion|0.9|||||TWO_SIDED|95.0|0.17|5.15|||Score CI|CI for Week 20 (in clinic)||||5.15|0.17|
71056758|NCT03968978|141617896|SUPERIORITY||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.53|||Score CI|CI for Week 0 (in clinic)||||3.53|0|
71056759|NCT03968978|141617896|OTHER||Proportion|2.8|||||TWO_SIDED|95.0|0.97|7.99|||Score CI|CI for Week 4 (in clinic)||||7.99|0.97|
71056760|NCT03968978|141617896|OTHER||Proportion|1.9|||||TWO_SIDED|95.0|0.52|6.68|||Other CI|CI for Week 8 (in clinic)||||6.68|0.52|
71056761|NCT03968978|141617896|OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.56|||Score CI|CI for week 12 (at home)||||3.56|0|
71056762|NCT03968978|141617896|OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.63|||Score CI|CI for Week 16 (at home)||||3.63|0|
71056763|NCT03968978|141617896|OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.63|||Score CI|CI for Week 20 (in clinic)||||3.63|0|
71056764|NCT02883049|141617960|SUPERIORITY||Hazard Ratio (HR)|1.022||||0.893|TWO_SIDED|95.0|0.74|1.413|||Log Rank||Hazard ratio = hazard rate for Arm B/hazard rate for Arm A|To compare the DFS of the randomized patients on HR B-ALL Arm A vs Arm B. With a total of 1800 patients accrued over 5 years with minimum follow up of 2 years, randomized 1:1 to the 2 arms, we will be able to detect an improvement in 5-year DFS from 90% to 94 (HR=0.5873) between IT MTX and ITT based regimens (2-sided log rank test, alpha=5%), with 84.2% power.||1.413|0.74|0.893
71056765|NCT02883049|141617961|SUPERIORITY||Hazard Ratio (HR)|1.019||||0.556|ONE_SIDED|97.5||1.335|||Log Rank||Hazard ratio = hazard rate for Experimental Arm 1 /hazard rate for Control Arm|To compare the DFS of the randomized patients on Control Arm vs. Experimental Arm 1. This study design will have 86.8% power (1-sided log rank test, adjusted alpha=0.025 for multiple comparisons) to detect an improvement in 4-year DFS from 70% to 79% (HR=0.661) between the control arm and the experimental arm.||1.335||0.556
71056766|NCT00826007|141617992|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.18|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|0.09|0.18|||Regression, Logistic|||||.18|.09|<0.001
71056767|NCT01392963|141617997|OTHER|||||||0.001|||||||Mixed Models Analysis|||||||0.001
71056768|NCT00369486|141617999|SUPERIORITY_OR_OTHER|||||||0.46||95.0||||Adjusted for baseline central subfield thickness|repeated measures least sq. regression|Models adjusted for baseline values and for correlated data from subjects with two study eyes.||Comparison of change in central subfield thickening from baseline to 34 weeks in all five groups.||||0.46
71056769|NCT00369486|141618000|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5||||0.04||95.0|0.2|1.0|||generalized estimating equations|||Analysis combined posterior and anterior injection + laser groups to compare with laser only.||1.0|0.2|0.04
71056770|NCT00369486|141618000|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.63||95.0|0.5|2.9|||generalized estimating equations|||Analysis combined posterior and anterior injection only groups to compare with laser only treatment group.||2.9|0.5|0.63
71056771|NCT00369486|141618001|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||repeated measures least sq. regression|Adjusted for baseline values and for the correlated data from subjects with two study eyes.||Comparison of the mean change in visual acuity letter score among the five groups at 34 weeks. Negative changes represent a worsening in visual acuity.||||0.94
71107937|NCT02949011|141721537|SUPERIORITY|||||||0.7383||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||0.7383
71023182|NCT01360632|141553880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.0912|TWO_SIDED|95.0|-0.28|0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.02|-0.28|0.0912
71056772|NCT02856802|141618057|NON_INFERIORITY|Assumption that 15% of placebo and 42% of DFN 02 10 mg (treated) subjects would be pain-free at 2 hours. A sample size of 50 subjects in each DB1 dosing arm provided 86% power to detect this assumed difference between placebo and DFN-02 10 mg at a 5% (2-sided) level of significance.|Odds Ratio (OR)|2.68||||0.044|TWO_SIDED|95.0|1.05|6.83|||Fisher Exact|||Statistical testing and confidence intervals (CIs) were 2 sided and performed using a significance (alpha) level of 0.05. All statistical analyses were conducted with the statistical analysis system (SAS)® software package (version 9.3).||6.83|1.05|0.044
71056773|NCT02856802|141618058|NON_INFERIORITY|Non-inferiority conducted as specified in the statistical analysis plan (SAP).||||||0.007||||||The corresponding p-values from Fisher's exact test were computed for the comparison between treatment groups.|Fisher Exact|||||||0.007
71056774|NCT02856802|141618059|NON_INFERIORITY|No assumptions made.|Odds Ratio (OR)|1.31||||0.642|TWO_SIDED|95.0|0.52|3.3|||Fisher Exact|||Statistical testing and confidence intervals (CIs) were 2 sided and performed using a significance (alpha) level of 0.05. All statistical analyses were conducted with the SAS® software package (version 9.3).||3.30|0.52|0.642
71056775|NCT00580788|141618093|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds to change over time for the PTHrP 2 and PTHrP 5 pmol groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>0.05
71056776|NCT00580788|141618093|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.01|TWO_SIDED|||||the reported p value corresponds to a decrease by Day 8 compared to baseline in the PTHrP 4 pmol group|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||0.01
71056777|NCT00580788|141618095|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.61|TWO_SIDED|||||The reported p-value corresponds to all Arms/Groups at all time points compared to baseline|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||0.61
71056778|NCT00580788|141618096|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||The reported p-value corresponds to the increase over time for the PTHrP 4 pmol group.|Mixed Models Analysis|Value The level of statistical significance was set at .05 (two-tailed)||||||<0.0001
71107938|NCT02949011|141721537|SUPERIORITY|||||||0.9619||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||0.9619
70934105|NCT02294461|141368986|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7||||0.0208|TWO_SIDED|95.0|0.51|0.95||P-value is based on an unstratified log-rank test.|Unstratified log-rank test|||Participants who were not known to have had died at the analysis date were censored at date last known alive. Hazard ratio calculated using unstratified Cox Proportional Hazards model with treatment as the only covariate for enzalutamide group versus placebo group.||0.95|0.51|0.0208
70934106|NCT02294461|141368987|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.31|||<|0.0001||95.0|0.2|0.46||P-value is based on an unstratified log-rank test.|Unstratified log-rank test|||Participants who were not known to have had an rPFS event were censored at the date of the last assessment showing no objective evidence of rPFS prior to scan modality change, new antineoplastic treatment, initiation of radiation therapy for prostate cancer, skeletal-related event (SRE) and 2 or more consecutive missed tumor assessments. Hazard ratio calculated using unstratified Cox Proportional Hazards model with treatment as the only covariate for enzalutamide.||0.46|0.20|<0.0001
70934107|NCT02294461|141368988|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.56||||0.2501|TWO_SIDED|95.0|0.21|1.52||P-value was based on an unstratified log-rank test.|Unstratified log-rank test|||Participants who did not have an SRE were censored at the date of the last assessment indicating no evidence of SRE. Hazard ratio calculated using unstratified Cox Proportional Hazards model with treatment as the only covariate for enzalutamide group versus placebo group.||1.52|0.21|0.2501
71023183|NCT01360632|141553880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.1553|TWO_SIDED|95.0|-0.28|0.04|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.04|-0.28|0.1553
71023184|NCT01360632|141553880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.1855|TWO_SIDED|95.0|-0.27|0.05|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.05|-0.27|0.1855
71023185|NCT01360632|141553880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.2015|TWO_SIDED|95.0|-0.28|0.06|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.06|-0.28|0.2015
71023186|NCT01360632|141553880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.0852|TWO_SIDED|95.0|-0.32|0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.02|-0.32|0.0852
71107939|NCT02949011|141721537|SUPERIORITY|||||||0.0576||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||0.0576
71107940|NCT02949011|141721537|SUPERIORITY|||||||0.1237||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||0.1237
70934108|NCT02294461|141368989|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.28||||0.002||95.0|0.12|0.66||P-value is based on an unstratified log-rank test.|Unstratified log-rank test|||Participants who did not start cytotoxic chemotherapy were censored at the date of the last assessment indicating no evidence of cytotoxic chemotherapy usage. Hazard ratio calculated using unstratified Cox Proportional Hazards model with treatment as the only covariate for enzalutamide group versus placebo group.||0.66|0.12|0.0020
70934109|NCT02294461|141368990|SUPERIORITY_OR_OTHER_LEGACY||Difference of response rate|55.8|||<|0.0001|TWO_SIDED|95.0|47.4|64.2||P-value is based on unstratified Cochran-Mantel-Haenszel mean score test.|Unstratified Cochran-Mantel-Haenszel %|||||64.2|47.4|<0.0001
71023187|NCT01360632|141553881|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.08||||0.0817|TWO_SIDED|95.0|-0.17|0.01|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.01|-0.17|0.0817
71023188|NCT01360632|141553881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.1406|TWO_SIDED|95.0|-0.16|0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.02|-0.16|0.1406
71023189|NCT01360632|141553881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.011|TWO_SIDED|95.0|-0.29|-0.04|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.04|-0.29|0.011
71023190|NCT01360632|141553881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.0287|TWO_SIDED|95.0|-0.27|-0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.02|-0.27|0.0287
71023191|NCT01360632|141553881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.0071|TWO_SIDED|95.0|-0.32|-0.05|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.05|-0.32|0.0071
71023192|NCT01360632|141553881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.2503|TWO_SIDED|95.0|-0.22|-0.06|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.06|-0.22|0.2503
70934110|NCT02294461|141368991|SUPERIORITY_OR_OTHER_LEGACY||Difference in objective response rate|26.0|||<|0.0001|TWO_SIDED|95.0|14.7|37.4||P-value is based on unstratified Cochran-Mantel-Haenszel mean score test.|Unstratified Cochran-Mantel-Haenszel|||When deriving the response category, it was based on the target, non-target and new lesions without confirming CR, PR, and Progressive disease (PD). Participants with no post baseline assessment were included in the category of Nonevaluable (NE). The best overall soft tissue objective response was defined as PR or CR based on the investigator assessments of target, non-target and new lesions while on the study treatment.||37.4|14.7|<0.0001
70934111|NCT00378898|141369030|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||.047
71056779|NCT00580788|141618097|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||The reported p-value corresponds to the increase over time for the PTHrP 4 pmol group.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<0.0001
71056780|NCT00580788|141618098|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds to change over time from baseline for all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>.05
71056781|NCT00580788|141618099|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.008|TWO_SIDED|||||The reported p-value corresponds to the % increase compared to baseline in all Arms/groups on Days 2-8.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.008
71056782|NCT00580788|141618099|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds the the % change from baseline at follow-up in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>0.05
71056783|NCT00580788|141618100|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||The reported p-value corresponds to % change (increase) from baseline in all Arms/groups at Days 2-8.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.0001
71056784|NCT00580788|141618100|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds to the % change from baseline at follow-up in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>0.05
71056785|NCT00580788|141618101|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||the reported p-value corresponds to % decrease compared to baseline at Days 2-8 in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.0001
71056786|NCT00580788|141618101|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.01|TWO_SIDED|||||the reported p-value corresponds to % change from baseline at the follow-up visit in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||0.01
71056787|NCT00580788|141618102|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.001|TWO_SIDED|||||the reported p-value correspond to the decrease compared to baseline over time in the PTHrP 4 pmol group.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||0.001
70934112|NCT00089609|141369092|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||.02
70934113|NCT03559205|141369103|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.96|TWO_SIDED|95.0|-0.74|0.7|||t-test, 2 sided|||2 Week Analysis||0.70|-0.74|0.96
70934114|NCT03559205|141369104|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.9|TWO_SIDED|95.0|-2.31|2.04|||t-test, 2 sided|||Baseline||2.04|-2.31|0.90
71023193|NCT01360632|141553881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.0539|TWO_SIDED|95.0|-0.3|0.0|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0|-0.3|0.0539
70934115|NCT03559205|141369104|SUPERIORITY||Mean Difference (Final Values)|2.01||||0.21|TWO_SIDED|95.0|-1.17|5.19|||t-test, 2 sided|||2 Week Analysis||5.19|-1.17|0.21
71023194|NCT01360632|141553881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.0398|TWO_SIDED|95.0|-0.31|-0.01|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.01|-0.31|0.0398
70934116|NCT03559205|141369104|SUPERIORITY||Mean Difference (Final Values)|0.94||||0.63|TWO_SIDED|95.0|-2.95|4.83|||t-test, 2 sided|||3-Month||4.83|-2.95|0.63
70934117|NCT03559205|141369105|SUPERIORITY||Mean Difference (Final Values)|2.63||||0.15|TWO_SIDED|95.0|-1.0|6.26|||t-test, 2 sided|||Baseline||6.26|-1.00|0.15
71023195|NCT01360632|141553881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.1168|TWO_SIDED|95.0|-0.3|0.03|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.03|-0.3|0.1168
71023196|NCT01360632|141553881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.0621|TWO_SIDED|95.0|-0.32|0.01|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.01|-0.32|0.0621
71023197|NCT01360632|141553881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.089|TWO_SIDED|95.0|-0.32|0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.02|-0.32|0.089
71056788|NCT00580788|141618102|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.01|TWO_SIDED|||||the reported p=value corresponds to % change compared to baseline at follow-up in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||.01
70934118|NCT03559205|141369105|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.3|TWO_SIDED|95.0|-2.02|6.45|||t-test, 2 sided|||Week 2 analysis||6.45|-2.02|0.30
70934119|NCT03559205|141369105|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.85|TWO_SIDED|95.0|-4.89|5.9|||t-test, 2 sided|||3-Month||5.90|-4.89|0.85
71023198|NCT01360632|141553881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.0213|TWO_SIDED|95.0|-0.38|-0.03|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.03|-0.38|0.0213
71023199|NCT01360632|141553882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.0228|TWO_SIDED|95.0|-2.37|-0.18|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.18|-2.37|0.0228
71056789|NCT00580788|141618103|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.05|TWO_SIDED|||||the reported p-values correspond to the decrease compared to baseline in all arms/groups at Days 2-8|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<0.05
71056790|NCT00580788|141618104|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.002|TWO_SIDED|||||the reported p-value corresponds to the increase comapred to baseline over time (days 2-8) in the PTHrP 4 pmol group|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||.002
71077936|NCT02913105|141664399|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.3419|TWO_SIDED|90.0|0.85|1.05|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 84||1.05|0.85|0.3419
70934120|NCT03559205|141369106|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.72|TWO_SIDED|95.0|-0.51|0.74|||t-test, 2 sided|||Care and respect||0.74|-0.51|0.72
71056791|NCT03743415|141618113|SUPERIORITY|The key parameter was the coefficient for the trial arm difference in linear mixed effects model that reflected average difference between arms over time (weeks 1-13).|Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|1.16||0.81|TWO_SIDED|95.0|-2.5|1.96||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Linear mixed effects models were used for 13 repeated measures of the symptom index, adjusting for baseline value.|Mean of SMSH alone minus mean of SMSH+TIPC|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. The adjusted effect size d=0.54 between the SMSH alone group and SMSH+TIPC group was detectable with power of .94 in two-sided tests at .05 level of significance.||1.96|-2.50|.81
71056792|NCT03743415|141618113|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|2.07||0.78|TWO_SIDED|95.0|-4.65|3.49||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|The model included adjustment for baseline value of the symptom index.|Mean of SMSH alone minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. The adjusted effect size d=0.54 between the SMSH alone group and SMSH+TIPC group was detectable with power of .94 in two-sided tests at .05 level of significance.||3.49|-4.65|.78
71056793|NCT03743415|141618113|SUPERIORITY|The key parameter was the coefficient for the trial arm difference in linear mixed effects model that included reflected average difference between arms over time (weeks 1-13).|Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.76||0.27|TWO_SIDED|95.0|-0.66|2.32||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. The adjusted effect size d=0.54 between the SMSH alone group and SMSH+TIPC group was detectable with power of .94 in two-sided tests at .05 level of significance.||2.32|-0.66|.27
71107941|NCT02949011|141721537|SUPERIORITY|||||||0.3071||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.3071
71107942|NCT02949011|141721537|SUPERIORITY|||||||0.9603||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.9603
71107943|NCT02949011|141721537|SUPERIORITY|||||||0.0784||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.0784
71107944|NCT02949011|141721537|SUPERIORITY|||||||0.5547||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.5547
71107945|NCT02949011|141721537|SUPERIORITY|||||||0.3087||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.3087
70934121|NCT03559205|141369106|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.46|TWO_SIDED|95.0|-0.38|0.83|||t-test, 2 sided|||Understanding \& engagement||0.83|-0.38|0.46
71023200|NCT01360632|141553882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.5081|TWO_SIDED|95.0|-1.47|0.73|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.73|-1.47|0.5081
71023201|NCT01360632|141553882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.86||||0.0064|TWO_SIDED|95.0|-3.2|-0.53|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.53|-3.2|0.0064
71023202|NCT01360632|141553882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89||||0.1898|TWO_SIDED|95.0|-2.23|0.44|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.44|-2.23|0.1898
71107946|NCT02949011|141721537|SUPERIORITY|||||||0.9106||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.9106
71107947|NCT02949011|141721537|SUPERIORITY|||||||0.0017||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.0017
71107948|NCT02949011|141721537|SUPERIORITY|||||||0.3068||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.3068
71023203|NCT01360632|141553882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.09||||0.0074|TWO_SIDED|95.0|-3.62|-0.56|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.56|-3.62|0.0074
71023204|NCT01360632|141553882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.5935|TWO_SIDED|95.0|-1.95|1.11|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||1.11|-1.95|0.5935
71023205|NCT01360632|141553882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.0211|TWO_SIDED|95.0|-3.52|-0.29|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.29|-3.52|0.0211
71023206|NCT01360632|141553882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.1031|TWO_SIDED|95.0|-2.96|0.27|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.27|-2.96|0.1031
71023207|NCT01360632|141553882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1366||||0.1366|TWO_SIDED|95.0|-3.02|0.41|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.41|-3.02|0.1366
71023208|NCT01360632|141553882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96||||0.2709|TWO_SIDED|95.0|-2.68|0.75|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.75|-2.68|0.2709
70934122|NCT03559205|141369107|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.3|TWO_SIDED|95.0|-0.13|0.42|||t-test, 2 sided|||2-weeks||0.42|-0.13|0.30
71023209|NCT01360632|141553882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.0812|TWO_SIDED|95.0|-3.4|0.2|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.2|-3.4|0.0812
71023210|NCT01360632|141553882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.52||||0.1001|TWO_SIDED|95.0|-3.33|0.29|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.29|-3.33|0.1001
71023211|NCT01360632|141553883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12||||0.0496|TWO_SIDED|95.0|-2.24|0.0|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0|-2.24|0.0496
71023212|NCT01360632|141553883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.387|TWO_SIDED|95.0|-1.61|0.63|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.63|-1.61|0.387
71023213|NCT01360632|141553883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75||||0.0125|TWO_SIDED|95.0|-3.13|-0.38|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.38|-3.13|0.0125
71056794|NCT03743415|141618113|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|1.76|STANDARD_ERROR_OF_MEAN|1.35||0.19|TWO_SIDED|95.0|-0.88|4.39||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH alone minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. The adjusted effect size d=0.54 between the SMSH alone group and SMSH+TIPC group was detectable with power of .94 in two-sided tests at .05 level of significance.||4.39|-0.88|.19
70934123|NCT03559205|141369107|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.38|TWO_SIDED|95.0|-0.2|0.52|||t-test, 2 sided|||3-months||0.52|-0.20|0.38
71023214|NCT01360632|141553883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19||||0.0898|TWO_SIDED|95.0|-2.57|0.19|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.19|-2.57|0.0898
71023215|NCT01360632|141553883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.31||||0.004|TWO_SIDED|95.0|-3.88|-0.74|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.74|-3.88|0.004
71023216|NCT01360632|141553883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.301|TWO_SIDED|95.0|-2.4|0.74|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.74|-2.4|0.301
71056795|NCT03743415|141618114|SUPERIORITY|The key parameter was the coefficient for the trial arm difference in linear mixed effects model that included reflected average difference between arms over weeks 5-13.|Mean Difference (Final Values)|2.43|STANDARD_ERROR_OF_MEAN|2.46||0.53|TWO_SIDED|95.0|-3.3|6.36||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH alone minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. . The adjusted effect size (Cohen's d=0.54) was used to power comparisons on the primary outcomes reported by groups from the second randomization. This analysis indicated that 60 per group would be required for power of .80 or greater in two-sided tests at α= 0.05.||6.36|-3.30|.53
71056796|NCT03743415|141618114|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|1.99|STANDARD_ERROR_OF_MEAN|3.92||0.97|TWO_SIDED|95.0|-5.7|9.68||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH alone minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. . The adjusted effect size (Cohen's d=0.54) was used to power comparisons on the primary outcomes reported by groups from the second randomization. This analysis indicated that 60 per group would be required for power of .80 or greater in two-sided tests at α= 0.05.||9.68|-5.70|.97
71056797|NCT03743415|141618114|SUPERIORITY|The key parameter was the coefficient for the trial arm difference in linear mixed effects model that included reflected average difference between arms over weeks 5-13.|Mean Difference (Final Values)|1.96|STANDARD_ERROR_OF_MEAN|1.94||0.31|TWO_SIDED|95.0|-1.83|5.75||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH alone minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. . The adjusted effect size (Cohen's d=0.54) was used to power comparisons on the primary outcomes reported by groups from the second randomization. This analysis indicated that 60 per group would be required for power of .80 or greater in two-sided tests at α= 0.05.||5.75|-1.83|.31
71056798|NCT03743415|141618114|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Net)|3.3|STANDARD_ERROR_OF_MEAN|2.77||0.61|TWO_SIDED|95.0|-2.13|8.74||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. The adjusted effect size (Cohen's d=0.54) was used to power comparisons on the primary outcomes reported by groups from the second randomization. This analysis indicated that 60 per group would be required for power of .80 or greater in two-sided tests at α= 0.05.||8.74|-2.13|.61
71056799|NCT03743415|141618115|SUPERIORITY|Key parameter was the difference between arms at week 13.|Mean Difference (Final Values)|-0.99|STANDARD_ERROR_OF_MEAN|1.14||0.44|TWO_SIDED|95.0|-3.12|1.35||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Regression, Linear|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||1.35|-3.12|.44
71056800|NCT03743415|141618115|SUPERIORITY|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|1.15||0.95|TWO_SIDED|95.0|-2.32|2.18||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.||2.18|-2.32|.95
71077937|NCT02913105|141664399|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.98||||0.7281|TWO_SIDED|90.0|0.88|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 112 (EOS)||1.09|0.88|0.7281
70934124|NCT03559205|141369108|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.61|TWO_SIDED|95.0|-1.48|0.88|||t-test, 2 sided|||||0.88|-1.48|0.61
71107949|NCT02949011|141721538|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||<0.0001
71023217|NCT01360632|141553883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15||||0.0118|TWO_SIDED|95.0|-3.82|-0.48|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.48|-3.82|0.0118
71023218|NCT01360632|141553883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.87||||0.0287|TWO_SIDED|95.0|-3.54|-0.19|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.19|-3.54|0.0287
71023219|NCT01360632|141553883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63||||0.0686|TWO_SIDED|95.0|-3.39|0.12|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.12|-3.39|0.0686
71023220|NCT01360632|141553883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72||||0.056|TWO_SIDED|95.0|-3.47|0.04|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.04|-3.47|0.056
71023221|NCT01360632|141553883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.0448|TWO_SIDED|95.0|-3.75|-0.04|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.04|-3.75|0.0448
71023222|NCT01360632|141553883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.13||||0.0251|TWO_SIDED|95.0|-3.98|-0.27|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.27|-3.98|0.0251
71023223|NCT01360632|141553884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67||||0.1732|TWO_SIDED|95.0|-1.63|0.29|||ANCOVA|||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The last observation carried forward (LOCF) method was used to impute missing data.||0.29|-1.63|0.1732
71023224|NCT01360632|141553884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.0066|TWO_SIDED|95.0|-2.31|-0.37|||ANCOVA|||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The last observation carried forward (LOCF) method was used to impute missing data.||-0.37|-2.31|0.0066
70934125|NCT04237792|141369122|OTHER||Odds Ratio (OR)|0.1|||<|0.001|TWO_SIDED|95.0|0.03|0.29|||Cochran-Mantel-Haenszel|||||0.29|0.03|<0.001
71023225|NCT01360632|141553885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.1226|TWO_SIDED|95.0|-1.78|0.21|||ANCOVA|||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||0.21|-1.78|0.1226
71023226|NCT01360632|141553885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69||||0.001|TWO_SIDED|95.0|-2.69|-0.68|||ANCOVA|||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.68|-2.69|0.001
71023227|NCT01360632|141553886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.8164|TWO_SIDED|95.0|-0.93|0.73|||ANCOVA|||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0.73|-0.93|0.8164
71023228|NCT01360632|141553886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.1939|TWO_SIDED|95.0|-1.39|0.28|||ANCOVA|||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0.28|-1.39|0.1939
71107950|NCT02949011|141721538|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||<0.0001
70934126|NCT04237792|141369123|OTHER||Odds Ratio (OR)|0.18||||0.022|TWO_SIDED|95.0|0.04|0.82|||Mantel Haenszel|||||0.82|0.04|0.022
71107951|NCT02949011|141721538|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||<0.0001
70934127|NCT04237792|141369123|OTHER||Odds Ratio (OR)|0.05|||<|0.001|TWO_SIDED|95.0|0.01|0.26|||Mantel Haenszel|||||0.26|0.01|<0.001
70934128|NCT04237792|141369124|OTHER||Odds Ratio (OR)|0.11||||0.006|TWO_SIDED|95.0|0.02|0.59|||Mantel Haenszel|||||0.59|0.02|0.006
70934129|NCT04237792|141369124|OTHER||Odds Ratio (OR)|1.68||||0.597|TWO_SIDED|95.0|0.25|11.27|||Mantel Haenszel|||||11.27|0.25|0.597
70934130|NCT04237792|141369124|OTHER||Odds Ratio (OR)|0.54||||0.374|TWO_SIDED|95.0|0.14|2.07|||Mantel Haenszel|||||2.07|0.14|0.374
70934131|NCT04237792|141369124|OTHER||Odds Ratio (OR)|0.1||||0.001|TWO_SIDED|95.0|0.02|0.44|||Mantel Haenszel|||||0.44|0.02|0.001
70934132|NCT04237792|141369124|OTHER||Odds Ratio (OR)|0.32||||0.015|TWO_SIDED|95.0|0.13|0.81|||Mantel Haenszel|||||0.81|0.13|0.015
70934133|NCT04237792|141369124|OTHER||Odds Ratio (OR)|0.3||||0.024|TWO_SIDED|95.0|0.1|0.87|||Mantel Haenszel|||||0.87|0.10|0.024
71023229|NCT01360632|141553887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.5192|TWO_SIDED|95.0|-1.14|0.57|||ANCOVA|||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||0.57|-1.14|0.5192
71023230|NCT01360632|141553887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88||||0.0443|TWO_SIDED|95.0|-1.75|-0.02|||ANCOVA|||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.02|-1.75|0.0443
71023231|NCT01360632|141553888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.0248|TWO_SIDED|95.0|-0.26|-0.02|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from Cochran-Mantel-Haenszel (CMH) row mean score differ test controlling for study center.||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.02|-0.26|0.0248
71023232|NCT01360632|141553888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.1334|TWO_SIDED|95.0|-0.22|0.03|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean scores statistics controlling for study center.||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0.03|-0.22|0.1334
71056801|NCT03743415|141618115|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.96||0.97|TWO_SIDED|95.0|-1.85|1.93||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||1.93|-1.85|.97
71056802|NCT03743415|141618115|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.96||0.74|TWO_SIDED|95.0|-1.56|2.2||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||2.20|-1.56|.74
71077938|NCT02913105|141664399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.04||||0.318|TWO_SIDED|90.0|0.97|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 7||1.12|0.97|0.3180
71077939|NCT02913105|141664399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.02||||0.6576|TWO_SIDED|90.0|0.95|1.1|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 14||1.10|0.95|0.6576
71107952|NCT02949011|141721538|SUPERIORITY|||||||0.0024||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||0.0024
70934134|NCT04237792|141369125|OTHER|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
70934135|NCT04237792|141369125|OTHER|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
70934136|NCT04237792|141369125|OTHER|||||||0.225|||||||Wilcoxon (Mann-Whitney)|||||||0.225
70934137|NCT04237792|141369125|OTHER|||||||0.213|||||||Wilcoxon (Mann-Whitney)|||||||0.213
70934138|NCT04237792|141369125|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70934139|NCT04237792|141369125|OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||||||0.006
70934140|NCT04237792|141369125|OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
70934141|NCT04237792|141369125|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70934142|NCT04237792|141369125|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
70934143|NCT04237792|141369126|OTHER|||||||0.016|||||||Log Rank|||||||0.016
70934144|NCT04237792|141369126|OTHER|||||||0.005|||||||Log Rank|||||||0.005
70934145|NCT04237792|141369126|OTHER|||||||0.368|||||||Log Rank|||||||0.368
70934146|NCT04237792|141369126|OTHER|||||||0.358|||||||Log Rank|||||||0.358
70934147|NCT04237792|141369126|OTHER|||||||0|||||||Log Rank|||||||0.000
70934148|NCT04237792|141369126|OTHER|||||||0.001|||||||Log Rank|||||||0.001
70934149|NCT04237792|141369126|OTHER|||||||0.02|||||||Log Rank|||||||0.020
70934150|NCT04237792|141369126|OTHER|||||||0|||||||Log Rank|||||||0.000
70934151|NCT04237792|141369126|OTHER|||||||0.005|||||||Log Rank|||||||0.005
70934152|NCT04237792|141369127|OTHER|||||||0.884|||||||Log Rank|||||||0.884
70934153|NCT04237792|141369127|OTHER|||||||0.662|||||||Log Rank|||||||0.662
70934154|NCT04237792|141369127|OTHER|||||||0.236|||||||Log Rank|||||||0.236
71056803|NCT03743415|141618116|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|2.31||0.98|TWO_SIDED|95.0|-4.49|4.58||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus mean of SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||4.58|-4.49|.98
71056804|NCT03743415|141618116|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|2.34||0.7|TWO_SIDED|95.0|-5.48|3.68||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||3.68|-5.48|.70
71056805|NCT03743415|141618116|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|1.85||0.27|TWO_SIDED|95.0|-5.62|1.62||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||1.62|-5.62|.27
71056806|NCT03743415|141618116|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|1.84||0.91|TWO_SIDED|95.0|-3.4|3.81||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||3.81|-3.40|.91
71056807|NCT03743415|141618117|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|1.06||0.06|TWO_SIDED|95.0|-3.98|0.19||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||0.19|-3.98|.06
71056808|NCT03743415|141618117|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|-1.78|STANDARD_ERROR_OF_MEAN|1.0||0.09|TWO_SIDED|95.0|-3.81|0.11||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||0.11|-3.81|.09
71056809|NCT03743415|141618117|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.97||0.89|TWO_SIDED|95.0|-1.77|2.04||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||2.04|-1.77|.89
71056810|NCT03743415|141618117|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|0.96||0.47|TWO_SIDED|95.0|-1.2|2.58||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||2.58|-1.20|.47
71056811|NCT03743415|141618118|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|-1.41|STANDARD_ERROR_OF_MEAN|1.94||0.45|TWO_SIDED|95.0|-5.22|2.39||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||2.39|-5.22|.45
71056812|NCT03743415|141618118|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|1.97||0.82|TWO_SIDED|95.0|-3.59|4.12||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||4.12|-3.59|.82
71023233|NCT01360632|141553888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.0009|TWO_SIDED|95.0|-0.42|-0.11|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.11|-0.42|0.0009
71023234|NCT01360632|141553888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.0019|TWO_SIDED|95.0|-0.38|-0.09|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean scores statistics controlling for study center||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.09|-0.38|0.0019
71023235|NCT01360632|141553888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.0009|TWO_SIDED|95.0|-0.42|-0.11|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.11|-0.42|0.0009
71023236|NCT01360632|141553888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.0254|TWO_SIDED|95.0|-0.34|-0.02|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.02|-0.34|0.0254
71023237|NCT01360632|141553888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0035|TWO_SIDED|95.0|-0.41|-0.08|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.08|-0.41|0.0035
71023238|NCT01360632|141553888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.0152|TWO_SIDED|95.0|-0.39|-0.04|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.04|-0.39|0.0152
71023239|NCT01360632|141553888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.004|TWO_SIDED|95.0|-0.42|-0.08|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.08|-0.42|0.004
71023240|NCT01360632|141553888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.013|TWO_SIDED|95.0|-0.42|-0.05|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.05|-0.42|0.013
71023241|NCT01360632|141553888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.0755|TWO_SIDED|95.0|-0.33|0.02|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0.02|-0.33|0.0755
71023242|NCT01360632|141553888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.0527|TWO_SIDED|95.0|-0.39|0.0|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0|-0.39|0.0527
71023243|NCT01360632|141553889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.0275|TWO_SIDED|95.0|-0.26|-0.01|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.01|-0.26|0.0275
71023244|NCT01360632|141553889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.1583|TWO_SIDED|95.0|-0.22|0.04|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||0.04|-0.22|0.1583
71107953|NCT02949011|141721538|SUPERIORITY|||||||0.9127||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ven Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.9127
71107954|NCT02949011|141721538|SUPERIORITY|||||||0.5361||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.5361
71023245|NCT01360632|141553889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0021|TWO_SIDED|95.0|-0.41|-0.09|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.09|-0.41|0.0021
71023246|NCT01360632|141553889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.0018|TWO_SIDED|95.0|-0.4|-0.09|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.09|-0.4|0.0018
71023247|NCT01360632|141553889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.0011|TWO_SIDED|95.0|-0.43|-0.11|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.11|-0.43|0.0011
71023248|NCT01360632|141553889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.0235|TWO_SIDED|95.0|-0.36|-0.03|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.03|-0.36|0.0235
71023249|NCT01360632|141553889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.0021|TWO_SIDED|95.0|-0.44|-0.1|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.10|-0.44|0.0021
71023250|NCT01360632|141553889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.0111|TWO_SIDED|95.0|-0.42|-0.05|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.05|-0.42|0.0111
71023251|NCT01360632|141553889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.003|TWO_SIDED|95.0|-0.44|-0.09|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.09|-0.44|0.0030
71023252|NCT01360632|141553889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.0046|TWO_SIDED|95.0|-0.47|-0.09|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.09|-0.47|0.0046
71023253|NCT01360632|141553889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.0237|TWO_SIDED|95.0|-0.39|-0.03|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.03|-0.39|0.0237
71023254|NCT01360632|141553889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0171|TWO_SIDED|95.0|-0.45|-0.04|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.04|-0.45|0.0171
71023255|NCT01360632|141553890|SUPERIORITY_OR_OTHER||Ratio of response rate|1.37||||0.5279|TWO_SIDED|95.0|0.51|3.68|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||3.68|0.51|0.5279
71023256|NCT01360632|141553890|SUPERIORITY_OR_OTHER||Ratio of response rate|0.13||||0.0141|TWO_SIDED|95.0|0.02|0.94|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0.94|0.02|0.0141
71056813|NCT03743415|141618118|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|1.88||0.77|TWO_SIDED|95.0|-3.13|4.23||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||4.23|-3.13|.77
71107955|NCT02949011|141721538|SUPERIORITY|||||||0.5739||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.5739
71107956|NCT02949011|141721538|SUPERIORITY|||||||0.5466||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.5466
71023257|NCT01360632|141553890|SUPERIORITY_OR_OTHER||Ratio of response rate|1.92||||0.0484|TWO_SIDED|95.0|0.99|3.72|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||3.72|0.99|0.0484
71056814|NCT03743415|141618118|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|1.87||0.86|TWO_SIDED|95.0|-3.98|3.34||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||3.34|-3.98|.86
71056815|NCT01266031|141618123|SUPERIORITY_OR_OTHER|||||||0.26||||||Null hypothesis is: PFS 6 months of Bevacizumab = PFS 6 months of Bevacizumab + Vorinostat.|Chi-squared|||Null hypothesis is: progression free survival (PFS) 6 months of Bevacizumab = PFS 6 months of Bevacizumab + Vorinostat.||||0.26
71056816|NCT00005957|141618139|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.38|TWO_SIDED|95.0|0.72|1.13|||Log Rank||Hazard ratio (HR) estimation is for Standard Breast Irradiation arm versus Breast Radiation plus regional radiation arm.|It was estimated that the actuarial five year survival of patients on the control arm of this trial would be 80% and a 5% increase in five year survival with experiment arm is clinically interesting to detect. A sample size of 1832 will ensure 80% power to detect such a difference with two-sided alpha of 0.05.||1.13|0.72|0.38
71056817|NCT00005957|141618140|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||0.01|TWO_SIDED|95.0|0.61|0.94|||Log Rank|||||0.94|0.61|0.01
71056818|NCT01651793|141618270|SUPERIORITY|||||||0.05||||||P value reference to the beverage x time interaction effect|ANCOVA|||Hypotheses were tested using a series (all outcome variables) of 2 Treatment x 4 Time point, repeated measures ANCOVAs that controlled for the prior night's sleep. Primary interests were the presence of statistically significant interactions of time and either cocoa versus placebo, cocoa + caffeine versus cocoa, or cocoa + caffeine versus caffeine-only. Significant interactions were decomposed using one-way ANOVAs and t-tests with familywise error controlled using LSD post-hoc tests.||||0.05
71056819|NCT03713632|141618279|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0149|TWO_SIDED|95.0|1.05|2.55||one-sided p-value|Regression, Logistic|||||2.55|1.05|0.0149
71056820|NCT03713632|141618279|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0022|TWO_SIDED|95.0|1.22|2.96||one-sided p-value|Regression, Logistic|||||2.96|1.22|0.0022
71056821|NCT03713632|141618280|SUPERIORITY||Mean Difference (Net)|-16.33||||0.0051|TWO_SIDED|95.0|-28.79|-3.88||one-side p-value|ANCOVA|||||-3.88|-28.79|0.0051
71056822|NCT03713632|141618280|SUPERIORITY||Mean Difference (Net)|-22.94||||0.0001|TWO_SIDED|95.0|-35.24|-10.63||one-side p-value|ANCOVA|||||-10.63|-35.24|0.0001
71056823|NCT03713632|141618281|SUPERIORITY||Odds Ratio (OR)|0.68||||0.0732|TWO_SIDED|95.0|0.41|1.14||one-sided p-value|Regression, Logistic|||||1.14|0.41|0.0732
71056824|NCT03713632|141618281|SUPERIORITY||Odds Ratio (OR)|0.49||||0.0049|TWO_SIDED|95.0|0.29|0.84||one-sided p-value|Regression, Logistic|||||0.84|0.29|0.0049
71056825|NCT03713632|141618282|SUPERIORITY||Odds Ratio (OR)|2.29||||0.0026|TWO_SIDED|95.0|1.28|4.09||one-sided p-value|Regression, Logistic|||||4.09|1.28|0.0026
71056826|NCT03713632|141618282|SUPERIORITY||Odds Ratio (OR)|1.86||||0.0206|TWO_SIDED|95.0|1.03|3.37||one-sided p-value|Regression, Logistic|||||3.37|1.03|0.0206
71056827|NCT02892149|141618285|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.23|-0.1||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||-0.10|-0.23|
71056828|NCT02892149|141618286|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per Food and Drug Administration \[FDA\]) and 1.30 (per European Medicines Agency \[EMA\]).|Hazard Ratio (HR)|0.96||||0.4745|TWO_SIDED|95.0|0.828|1.117|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0017 has been reported in this section.||1.117|0.828|0.4745
71056829|NCT02892149|141618286|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96|||=|0.4877|TWO_SIDED|95.0|0.833|1.113|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 355 and 377 respectively; median time to first event (Q1, Q3) = 46.14 (24.71, 77.14) weeks versus 47.00 (22.43, 74.43) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.113|0.833|=0.4877
71056830|NCT02892149|141618287|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-0.25|-0.12||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||-0.12|-0.25|
71056831|NCT02892149|141618288|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96||||0.3718|TWO_SIDED|95.0|0.832|1.097|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0017 has been reported in this section.||1.097|0.832|0.3718
71056832|NCT02892149|141618288|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96|||=|0.4096|TWO_SIDED|95.0|0.84|1.096|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first MACE plus hospitalization for heart failure or thromboembolic event Excluding vascular access thrombosis for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 420 and 449 respectively; median time to first event (Q1, Q3) = 42.07 (21.50, 71.14) weeks versus 45.29 (22.29, 72.43) weeks, respectively.||1.096|0.840|=0.4096
71023258|NCT01360632|141553890|SUPERIORITY_OR_OTHER||Ratio of response rate|1.23||||0.5813|TWO_SIDED|95.0|0.6|2.5|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.50|0.60|0.5813
71023259|NCT01360632|141553890|SUPERIORITY_OR_OTHER||Ratio of response rate|1.51||||0.1236|TWO_SIDED|95.0|0.9|2.54|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.54|0.90|0.1236
71023260|NCT01360632|141553890|SUPERIORITY_OR_OTHER||Ratio of response rate|1.21||||0.4998|TWO_SIDED|95.0|0.7|2.1|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.10|0.70|0.4998
71023261|NCT01360632|141553890|SUPERIORITY_OR_OTHER||Ratio of response rate|1.64||||0.0365|TWO_SIDED|95.0|1.03|2.61|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.61|1.03|0.0365
71023262|NCT01360632|141553890|SUPERIORITY_OR_OTHER||Ratio of response rate|1.52||||0.0822|TWO_SIDED|95.0|0.95|2.43|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.43|0.95|0.0822
71023263|NCT01360632|141553890|SUPERIORITY_OR_OTHER||Ratio of response rate|1.19||||0.4049|TWO_SIDED|95.0|0.79|1.78|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.78|0.79|0.4049
71023264|NCT01360632|141553890|SUPERIORITY_OR_OTHER||Ratio of response rate|1.23||||0.2951|TWO_SIDED|95.0|0.84|1.8|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.80|0.84|0.2951
71023265|NCT01360632|141553890|SUPERIORITY_OR_OTHER||Ratio of response rate|1.53||||0.0248|TWO_SIDED|95.0|1.06|2.2|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.20|1.06|0.0248
71023266|NCT01360632|141553890|SUPERIORITY_OR_OTHER||Ratio of response rate|1.51||||0.0326|TWO_SIDED|95.0|1.03|2.21|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.21|1.03|0.0326
71023267|NCT01360632|141553891|SUPERIORITY_OR_OTHER||Ratio of response rate|0.87||||0.7993|TWO_SIDED|95.0|0.3|2.55|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.55|0.30|0.7993
71023268|NCT01360632|141553891|SUPERIORITY_OR_OTHER||Ratio of response rate|0.11||||0.0118|TWO_SIDED|95.0|0.01|0.93|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||0.93|0.01|0.0118
71023269|NCT01360632|141553891|SUPERIORITY_OR_OTHER||Ratio of response rate|1.5||||0.2825|TWO_SIDED|95.0|0.71|3.16|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||3.16|0.71|0.2825
71023270|NCT01360632|141553891|SUPERIORITY_OR_OTHER||Ratio of response rate|1.2||||0.6375|TWO_SIDED|95.0|0.58|2.5|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.50|0.58|0.6375
71023271|NCT01360632|141553891|SUPERIORITY_OR_OTHER||Ratio of response rate|1.62||||0.0923|TWO_SIDED|95.0|0.92|2.82|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.82|0.92|0.0923
71056833|NCT02892149|141618289|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.94||||0.3875|TWO_SIDED|95.0|0.777|1.131|||Gray's test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0017 has been reported in this section.||1.131|0.777|0.3875
70934155|NCT04237792|141369127|OTHER|||||||0.733|||||||Log Rank|||||||0.733
70934156|NCT04237792|141369127|OTHER|||||||0.128|||||||Log Rank|||||||0.128
71023272|NCT01360632|141553891|SUPERIORITY_OR_OTHER||Ratio of response rate|1.29||||0.3812|TWO_SIDED|95.0|0.73|2.3|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.30|0.73|0.3812
71023273|NCT01360632|141553891|SUPERIORITY_OR_OTHER||Ratio of response rate|1.63||||0.0464|TWO_SIDED|95.0|1.0|2.65|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.65|1.00|0.0464
71023274|NCT01360632|141553891|SUPERIORITY_OR_OTHER||Ratio of response rate|1.62||||0.049|TWO_SIDED|95.0|1.0|2.64|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.64|1.00|0.0490
71023275|NCT01360632|141553891|SUPERIORITY_OR_OTHER||Ratio of response rate|1.32||||0.2124|TWO_SIDED|95.0|0.85|2.06|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.06|0.85|0.2124
71023276|NCT01360632|141553891|SUPERIORITY_OR_OTHER||Ratio of response rate|1.41||||0.1078|TWO_SIDED|95.0|0.93|2.14|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.14|0.93|0.1078
71023277|NCT01360632|141553891|SUPERIORITY_OR_OTHER||Ratio of response rate|1.69||||0.0094|TWO_SIDED|95.0|1.14|2.5|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.50|1.14|0.0094
71056834|NCT02892149|141618289|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.95|||=|0.5007|TWO_SIDED|95.0|0.795|1.144|||Gray's test|||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first cardiovascular MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 225 and 242 respectively; median time to first event (Q1, Q3) = 43.29 (21.71, 77.14) weeks versus 45.79 (21.14, 73.86) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.144|0.795|=0.5007
71056835|NCT02892149|141618290|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96||||0.6281|TWO_SIDED|95.0|0.761|1.203|||Gray's test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0017 has been reported in this section.||1.203|0.761|0.6281
71056836|NCT02892149|141618290|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96|||=|0.6284|TWO_SIDED|95.0|0.766|1.195|||Gray's test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first cardiovascular death for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 150 and 160 respectively; median time to first event (Q1, Q3) = 43.71 (27.43, 77.14) weeks versus 49.29 (24.43, 74.07) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.195|0.766|=0.6284
71056837|NCT02892149|141618291|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96||||0.5811|TWO_SIDED|95.0|0.816|1.136|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0017 has been reported in this section.||1.136|0.816|0.5811
71107957|NCT02949011|141721538|SUPERIORITY|||||||0.0543||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.0543
71107958|NCT02949011|141721538|SUPERIORITY|||||||0.4677||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.4677
71107959|NCT02949011|141721538|SUPERIORITY|||||||0.0266||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.0266
71107960|NCT02949011|141721538|SUPERIORITY|||||||0.1281||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.1281
71107961|NCT02949011|141721539|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||<0.0001
70934157|NCT04237792|141369127|OTHER|||||||0.165|||||||Log Rank|||||||0.165
70934158|NCT04237792|141369127|OTHER|||||||0.752|||||||Log Rank|||||||0.752
70934159|NCT04237792|141369127|OTHER|||||||0.139|||||||Log Rank|||||||0.139
70934160|NCT04237792|141369127|OTHER|||||||0.051|||||||Log Rank|||||||0.051
70934161|NCT04237792|141369129|OTHER|||||||0.124|||||||ANOVA|||||||0.124
70934162|NCT04237792|141369129|OTHER|||||||0.186|||||||ANOVA|||||||0.186
70934163|NCT04237792|141369129|OTHER|||||||0.47|||||||ANOVA|||||||0.470
70934164|NCT04237792|141369129|OTHER|||||||0.845|||||||ANOVA|||||||0.845
70934165|NCT04237792|141369129|OTHER|||||||0.621|||||||ANOVA|||||||0.621
71023278|NCT01360632|141553891|SUPERIORITY_OR_OTHER||Ratio of response rate|1.65||||0.0162|TWO_SIDED|95.0|1.09|2.5|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.50|1.09|0.0162
71023279|NCT01360632|141553892|SUPERIORITY_OR_OTHER||Ratio of remission rate|1.03||||0.9498|TWO_SIDED|95.0|0.37|2.9|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.90|0.37|0.9498
71023280|NCT01360632|141553892|SUPERIORITY_OR_OTHER||Ratio of response rate|0.13||||0.0141|TWO_SIDED|95.0|0.02|0.94|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0.94|0.02|0.0141
71023281|NCT01360632|141553892|SUPERIORITY_OR_OTHER||Ratio of response rate|0.93||||0.8609|TWO_SIDED|95.0|0.4|2.17|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.17|0.40|0.8609
71023282|NCT01360632|141553892|SUPERIORITY_OR_OTHER||Ratio of response rate|0.59||||0.2846|TWO_SIDED|95.0|0.22|1.54|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.54|0.22|0.2846
71023283|NCT01360632|141553892|SUPERIORITY_OR_OTHER||Ratio of response rate|1.5||||0.248|TWO_SIDED|95.0|0.75|2.99|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.99|0.75|0.2480
71023284|NCT01360632|141553892|SUPERIORITY_OR_OTHER||Ratio of response rate|1.13||||0.7513|TWO_SIDED|95.0|0.54|2.37|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.37|0.54|0.7513
71056838|NCT02892149|141618291|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.95|||=|0.4878|TWO_SIDED|95.0|0.812|1.118|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first all-cause mortality for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 291 and 310 respectively; median time to first event (Q1, Q3) = 50.00 (29.71, 79.00) weeks versus 49.57 (25.86, 77.29) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.118|0.812|=0.4878
71056839|NCT03277066|141618315|SUPERIORITY||Lest-Squared Mean Differences|0.011||||0.011|TWO_SIDED||||||Mixed Models Analysis|||||||0.0110
71023285|NCT01360632|141553892|SUPERIORITY_OR_OTHER||Ratio of response rate|1.82||||0.0554|TWO_SIDED|95.0|0.99|3.35|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||3.35|0.99|0.0554
71056840|NCT03277066|141618315|SUPERIORITY||Lest-Squared Mean Differences|0.2835||||0.2835|TWO_SIDED||||||Mixed Models Analysis|||||||0.2835
71056841|NCT03774407|141618325|OTHER|||||||0.002||||||This P value reported was for bladder urinary frequency change from baseline to 9 months|p value|||||||0.002
71056842|NCT04841577|141618328|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the group GMT ratio \[Control group divided by Co Ad group\] for RSVPreF3 OA investigational vaccine is ≤ (equal to or smaller than) 1.5.|Adjusted group GMT ratio|1.27|||||TWO_SIDED|95.0|1.12|1.44||||||Adjusted ratios of Control group over Co-Ad Group in RSV-A Neutralizing antibody GMTs at one month after RSV\_PreF3 OA investigational vaccination. An Analysis of Covariance (ANCOVA) model was used to analyse post-vaccination log-transformed titers of RSV-A neutralizing antibodies The ANCOVA model included the treatment group, the age category (age at vaccination: 60-69, 70-79 or \>=80 years), country and sex as fixed effects and the pre-dose log-10 titer as covariate.||1.44|1.12|
71056843|NCT04841577|141618329|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the group GMT ratio \[Control group divided by Co Ad group\] for each of the FLU vaccine strains is ≤1.5.|Adjusted geometric mean titer ratio|1.17|||||TWO_SIDED|95.0|1.02|1.35||||||For the Flu A/Hong Kong/2671/2019 (H3N2) strain, an ANCOVA model was used to analyze post-vaccination log-transformed titers. The ANCOVA model included the treatment group, the age category (age at vaccination: 60-69, 70-79 or \>=80 years), country and sex as fixed effects and the pre-dose log-10 transformed titer as covariate.||1.35|1.02|
71107962|NCT02949011|141721539|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||<0.0001
70934166|NCT04237792|141369129|OTHER|||||||0.747|||||||ANOVA|||||||0.747
70934167|NCT04237792|141369129|OTHER|||||||0.218|||||||ANOVA|||||||0.218
71023286|NCT01360632|141553892|SUPERIORITY_OR_OTHER||Ratio of response rate|1.48||||0.2409|TWO_SIDED|95.0|0.76|2.87|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.87|0.76|0.2409
71023287|NCT01360632|141553892|SUPERIORITY_OR_OTHER||Ratio of response rate|1.18||||0.5538|TWO_SIDED|95.0|0.69|2.02|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.02|0.69|0.5538
71023288|NCT01360632|141553892|SUPERIORITY_OR_OTHER||Ratio of response rate|1.44||||0.1743|TWO_SIDED|95.0|0.85|2.41|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.41|0.85|0.1743
70934168|NCT04237792|141369129|OTHER|||||||0.181|||||||ANOVA|||||||0.181
70934169|NCT04237792|141369129|OTHER|||||||0.984|||||||ANOVA|||||||0.984
70934170|NCT04237792|141369130|OTHER|||||||0.048|||||||ANOVA|||||||0.048
70934171|NCT04237792|141369130|OTHER|||||||0.106|||||||ANOVA|||||||0.106
70934172|NCT04237792|141369130|OTHER|||||||0.196|||||||ANOVA|||||||0.196
70934173|NCT04237792|141369130|OTHER|||||||0.94|||||||ANOVA|||||||0.940
70934174|NCT04237792|141369130|OTHER|||||||0.824|||||||ANOVA|||||||0.824
70934175|NCT04237792|141369130|OTHER|||||||0.678|||||||ANOVA|||||||0.678
71056844|NCT04841577|141618329|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the group GMT ratio \[Control group divided by Co Ad group\] for each of the FLU vaccine strains is ≤1.5.|Adjusted geometric mean Titer ratio|1.22|||||TWO_SIDED|95.0|1.03|1.44||||||For the Flu A/Victoria/2570/2019 (H1N1) strain, an ANCOVA model was used to analyze post-vaccination log-transformed titers. The ANCOVA model included the treatment group, the age category (age at vaccination: 60-69, 70-79 or \>=80 years), country and sex as fixed effects and the pre-dose log-10 transformed titer as covariate.||1.44|1.03|
71056845|NCT04841577|141618329|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the group GMT ratio \[Control group divided by Co Ad group\] for each of the FLU vaccine strains is ≤1.5.|Adjusted geometric mean Titer ratio|1.17|||||TWO_SIDED|95.0|1.04|1.32||||||For the Flu B/Phuket/3073/2013 (Yamagata) strain, an ANCOVA model was used to analyze post-vaccination log-transformed titers. The ANCOVA model included the treatment group, the age category (age at vaccination: 60-69, 70-79 or \>=80 years), country and sex as fixed effects and the pre-dose log-10 transformed titer as covariate.||1.32|1.04|
70934176|NCT04237792|141369130|OTHER|||||||0.129|||||||ANOVA|||||||0.129
70934177|NCT04237792|141369130|OTHER|||||||0.16|||||||ANOVA|||||||0.160
70934178|NCT04237792|141369130|OTHER|||||||0.872|||||||ANOVA|||||||0.872
70934179|NCT00087022|141369165|SUPERIORITY|||||||0.737|||||||Log Rank|||||||0.737
70934180|NCT00087022|141369166|SUPERIORITY|||||||1.012|||||||Log Rank|||||||1.012
70934181|NCT00087022|141369169|SUPERIORITY|||||||0.022|||||||Log Rank|||||||0.022
70934182|NCT01957163|141369170|SUPERIORITY_OR_OTHER||Least squared mean difference|0.124|||<|0.001|TWO_SIDED|95.0|0.093|0.154|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.154|0.093|< 0.001
70934183|NCT01957163|141369170|SUPERIORITY_OR_OTHER||Least squared mean difference|0.128|||<|0.001|TWO_SIDED|95.0|0.098|0.159|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.159|0.098|<0.001
70934184|NCT01957163|141369171|SUPERIORITY_OR_OTHER||Least squared mean difference|0.153|||<|0.001|TWO_SIDED|95.0|0.118|0.187|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.187|0.118|<0.001
70934185|NCT01957163|141369171|SUPERIORITY_OR_OTHER||Least squared mean difference|0.14|||<|0.001|TWO_SIDED|95.0|0.106|0.175|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.175|0.106|<0.001
70934186|NCT03697603|141369172|SUPERIORITY||Mean Difference (Final Values)|-1.4||||0.0312|TWO_SIDED|95.0|-2.7|-0.1|||MMRM|||Statistical analysis to compare brexpiprazole 2 mg/day and placebo was performed at Week 6.||-0.1|-2.7|0.0312
70934187|NCT03697603|141369172|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.0089|TWO_SIDED|95.0|-3.0|-0.4|||MMRM|||Statistical analysis to compare brexpiprazole 1 mg/day and placebo was performed at Week 6.||-0.4|-3.0|0.0089
70934188|NCT03697603|141369173|OTHER||Diff|5.5||||0.1964|TWO_SIDED|95.0|-2.8|13.8|||Chi-squared|||Statistical analysis to compare brexpiprazole 2 mg/day and placebo was performed at Week 6.||13.8|-2.8|0.1964
70934189|NCT03697603|141369173|OTHER||Diff|5.5||||0.1969|TWO_SIDED|95.0|-2.8|13.7|||Chi-squared|||Statistical analysis to compare brexpiprazole 1 mg/day and placebo was performed at Week 6.||13.7|-2.8|0.1969
70934190|NCT02686658|141369174|OTHER|Model for repeated measures (MRM) and square root transformation was used to compare the treatment groups.|Least Squares Mean Difference|0.11||||0.0072|TWO_SIDED|95.0|||||Model for repeated measures (MRM)|||Difference in least squares means between groups calculated as (Sham) minus (Zimura).||||0.0072
70934191|NCT02686658|141369174|OTHER|Model for repeated measures (MRM) and square root transformation was used to compare treatment groups.|Least Squares Mean Difference|0.124||||0.0051|TWO_SIDED|95.0|||||Model for repeated measures (MRM)|||Difference in least squares means between groups calculated as (Sham) minus (Zimura).||||0.0051
70934192|NCT02686658|141369175|OTHER|Model for repeated measures (MRM) was used to compare the treatment groups.|Least Squares Mean Difference|1.39||||0.3464|TWO_SIDED||||||Model for repeated measures (MRM)|||Difference in least squares mean between groups calculated as (Zimura) minus (Sham).||||0.3464
71107963|NCT02949011|141721539|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||<0.0001
70934193|NCT02686658|141369175|OTHER|Model for repeated measures (MRM) was used to compare the treatment groups.|Least Squares Mean Difference|-0.28||||0.883|TWO_SIDED||||||Model for repeated measures (MRM)|||Difference in least squares mean between groups calculated as (Zimura) minus (Sham).||||0.8830
70851707|NCT01818752|141191315|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.906||||0.159|TWO_SIDED|95.0|0.746|1.101||The p-value boundary for PFS analysis was 0.02141.|Log Rank|Log-rank p-value (1-sided) stratified by ISS stage, choice of route of bortezomib administration, region and age.|The hazard ratio (Carfilzomib/Bortezomib) was estimated using a Cox proportional hazards model stratified by ISS stage, choice of route of bortezomib administration, region and age.|The inferential test associated with the primary analysis of PFS was assessed against an overall 1-sided significance level of α=0.025.||1.101|0.746|0.1590
71023289|NCT01360632|141553892|SUPERIORITY_OR_OTHER||Ratio of response rate|1.3||||0.2843|TWO_SIDED|95.0|0.81|2.07|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.07|0.81|0.2843
71023290|NCT01360632|141553892|SUPERIORITY_OR_OTHER||Ratio of response rate|1.19||||0.464|TWO_SIDED|95.0|0.74|1.92|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.92|0.74|0.4640
71023291|NCT01360632|141553893|SUPERIORITY_OR_OTHER||Ratio of response rate|0.6||||0.3867|TWO_SIDED|95.0|0.18|1.97|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.97|0.18|0.3867
71023292|NCT01360632|141553893|SUPERIORITY_OR_OTHER||Ratio of response rate|0.11||||0.0118|TWO_SIDED|95.0|0.01|0.93|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||0.93|0.01|0.0118
71023293|NCT01360632|141553893|SUPERIORITY_OR_OTHER||Ratio of response rate|0.59||||0.32|TWO_SIDED|95.0|0.21|1.66|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.66|0.21|0.3200
71023294|NCT01360632|141553893|SUPERIORITY_OR_OTHER||Ratio of response rate|0.6||||0.3266|TWO_SIDED|95.0|0.23|1.62|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.62|0.23|0.3266
71023295|NCT01360632|141553893|SUPERIORITY_OR_OTHER||Ratio of response rate|1.47||||0.3027|TWO_SIDED|95.0|0.7|3.1|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11 All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||3.10|0.70|0.3027
71023296|NCT01360632|141553893|SUPERIORITY_OR_OTHER||Ratio of response rate|1.17||||0.696|TWO_SIDED|95.0|0.54|2.52|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11 All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.52|0.54|0.6960
71056846|NCT04841577|141618329|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the group GMT ratio \[Control group divided by Co Ad group\] for each of the FLU vaccine strains is ≤1.5.|Adjusted geometric mean Titer ratio|1.1|||||TWO_SIDED|95.0|0.95|1.26||||||For the Flu B/Washington/02/2019 (Victoria) strain, an ANOVA model was used to analyze post-vaccination log-transformed titers. The ANCOVA model included the treatment group, the age category (age at vaccination: 60-69, 70-79 or \>=80 years), country and sex as fixed effects and the pre-dose log-10 transformed titer as covariate.||1.26|0.95|
71107964|NCT02949011|141721539|SUPERIORITY|||||||0.0015||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||0.0015
70934194|NCT02686658|141369176|OTHER|Model for repeated measures (MRM) was used to compare the treatment groups.|Least Squares Mean Difference|0.38||||0.8405|TWO_SIDED||||||Model for repeated measures (MRM)|||Difference in least squares mean between groups calculated as (Zimura) minus (Sham).||||0.8405
70934195|NCT02686658|141369176|OTHER|Model for repeated measures (MRM) was used to compare the treatment groups.|Least Squares Mean Difference|-1.44||||0.5017|TWO_SIDED||||||Model for repeated measures (MRM)|||Difference in least squares mean between groups calculated as (Zimura) minus (Sham).||||0.5017
71023297|NCT01360632|141553893|SUPERIORITY_OR_OTHER||Ratio of response rate|1.62||||0.1368|TWO_SIDED|95.0|0.86|3.07||CMH general association test controlling for trial site|Cochran-Mantel-Haenszel|||Statistical analysis 1 at Week 12 All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||3.07|0.86|0.1368
71023298|NCT01360632|141553893|SUPERIORITY_OR_OTHER||Ratio of response rate|1.48||||0.2387|TWO_SIDED|95.0|0.76|2.89|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.89|0.76|0.2387
71023299|NCT01360632|141553893|SUPERIORITY_OR_OTHER||Ratio of response rate|1.26||||0.4498|TWO_SIDED|95.0|0.69|2.28|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.28|0.69|0.4498
71056847|NCT04841577|141618330|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in seroconversion rate is ≤10% for HI antibody titers.|Difference in percentage|2.6|||||TWO_SIDED|95.0|-4.13|9.3|||Miettinen and Nurminen|||For the Flu A/Hong Kong/2671/2019 (H3N2) strain, the 2-sided 95% CI on group difference in seroconversion rate (Control group minus Co-Ad group).||9.30|-4.13|
71056848|NCT04841577|141618330|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in seroconversion rate is ≤10% for HI antibody titers.|Difference in percentage|4.53|||||TWO_SIDED|95.0|-0.77|9.83|||Miettinen and Nurminen|||For the Flu A/Victoria/2570/2019 (H1N1) strain, the 2-sided 95% CI on group difference in seroconversion rate (Control group minus Co-Ad group).||9.83|-0.77|
71056849|NCT04841577|141618330|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in seroconversion rate is ≤10% for HI antibody titers.|Difference in percentage|4.04|||||TWO_SIDED|95.0|-2.21|10.28|||Miettinen and Nurminen|||For the Flu B/Phuket/3073/2013 (Yamagata) strain, the 2-sided 95% CI on group difference in seroconversion rate (Control group minus Co-Ad group).||10.28|-2.21|
71056850|NCT04841577|141618330|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in seroconversion rate is ≤10% for HI antibody titers.|Difference in percentage|0.41|||||TWO_SIDED|95.0|-6.07|6.9|||Miettinen and Nurminen|||For the Flu B/Washington/02/2019 (Victoria) strain, the 2-sided 95% CI on group difference in seroconversion rate (Control group minus Co-Ad group).||6.90|-6.07|
71056851|NCT04841577|141618332|OTHER||Adjusted group GMT ratio|1.28|||||TWO_SIDED|95.0|1.09|1.51||||||Adjusted ratios of Control group over Co-Ad Group in RSV-B Neutralizing antibody GMTs at one month after RSV\_PreF3 OA investigational vaccination. An Analysis of Covariance (ANCOVA) model was used to analyse post-vaccination log-transformed titers of RSV-B neutralizing antibodies. The ANCOVA model included the treatment group, the age category (age at vaccination: 60-69, 70-79 or \>=80 years), country and sex as fixed effects and the pre-dose log-10 titer as covariate.||1.51|1.09|
71056852|NCT02257385|141618376|NON_INFERIORITY_OR_EQUIVALENCE|Alternate hypothesis:the difference between the trt means (umeclidinium/vilanterol minus indacaterol + tiotropium bromide) would be \> -50 milliliters (mL). If the lower CI (2.5% 1-sided significance level) of the statistical test should fall above -50 mL, then umeclidinium/vilanterol may be deemed statistically non-inferior to indacaterol plus tiotropium. If the lower CI (2.5% 1-sided significance) of the statistical testing exceeded 0 then, statistical superiority would have been established.|Least Squares Mean Difference|0.001||||0.964|TWO_SIDED|95.0|-0.029|0.03|||Mixed Models Analysis|||||0.030|-0.029|0.964
71056853|NCT02257385|141618377|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.023||||0.145|TWO_SIDED|95.0|-0.054|0.008|||Mixed Models Analysis|||||0.008|-0.054|0.145
71056854|NCT02458287|141618385|SUPERIORITY_OR_OTHER||LS Mean Difference|-63.4|STANDARD_ERROR_OF_MEAN|4.4|<|0.001|TWO_SIDED|95.0|-72.0|-54.7|||Mixed Models Repeated Measures (MMRM)|||LS-mean difference, associated 95% confidence intervals, and p-value are from MMRM model with fixed effects for treatment groups, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction as covariates.||-54.7|-72.0|<0.001
71056855|NCT02458287|141618394|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.0|STANDARD_ERROR_OF_MEAN|4.53|<|0.001|TWO_SIDED|95.0|-51.9|-34.0|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-34.0|-51.9|<0.001
71056856|NCT02458287|141618395|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.7|STANDARD_ERROR_OF_MEAN|2.86|<|0.001|TWO_SIDED|95.0|-45.4|-34.1|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-34.1|-45.4|<0.001
71056857|NCT02458287|141618395|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.7|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|-32.5|-20.8|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-20.8|-32.5|<0.001
71056858|NCT02458287|141618396|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.9|STANDARD_ERROR_OF_MEAN|4.25|<|0.001|TWO_SIDED|95.0|-66.2|-49.5|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-49.5|-66.2|<0.001
71056859|NCT02458287|141618396|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.8|STANDARD_ERROR_OF_MEAN|4.38|<|0.001|TWO_SIDED|95.0|-44.4|-27.1|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-27.1|-44.4|<0.001
71056860|NCT02458287|141618397|SUPERIORITY_OR_OTHER||LS Mean Difference|-56.2|STANDARD_ERROR_OF_MEAN|3.84|<|0.001|TWO_SIDED|95.0|-63.7|-48.6|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-48.6|-63.7|<0.001
71056861|NCT02458287|141618397|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.2|STANDARD_ERROR_OF_MEAN|3.99|<|0.001|TWO_SIDED|95.0|-45.0|-29.3|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-29.3|-45.0|<0.001
71056862|NCT02800642|141618405|OTHER||||||<|0.0001|||||||Exact one-sided 1-sample binomial test|||"The null hypothesis the proportion of participants with a ≥ 15-letter gain in BCVA at Week 76 is ≤ 40% on the 2.5% level of significance (one-sided) was performed using the following criterion: If the p value is less than 2.5%, the null hypothesis will be rejected. Otherwise, the null hypothesis will be regarded as not rejected and may still be true"||||<0.0001
71107965|NCT02949011|141721539|SUPERIORITY|||||||0.0028||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.0028
70934196|NCT03924869|141369228|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.2932|TWO_SIDED|95.0|0.69|1.24||1-sided p-value based on log-rank test stratified by Disease Stage, ECOG Performance Status, Geographic Region of Enrollment Site, and Reason For Not Receiving Surgery.|Log Rank|||"Hazard ratio and 95% confidence intervals (CIs) were based on Cox regression model with Efron's method of tie handling with treatment as a covariate, stratified by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery)."||1.24|0.69|0.29320
71023300|NCT01360632|141553893|SUPERIORITY_OR_OTHER||Ratio of response rate|1.6||||0.1009|TWO_SIDED|95.0|0.91|2.82|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.82|0.91|0.1009
71023301|NCT01360632|141553893|SUPERIORITY_OR_OTHER||Ratio of response rate|1.45||||0.1499|TWO_SIDED|95.0|0.87|2.41|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.41|0.87|0.1499
71023302|NCT01360632|141553893|SUPERIORITY_OR_OTHER||Ratio of response rate|1.31||||0.3012|TWO_SIDED|95.0|0.78|2.18|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.18|0.78|0.3012
71023303|NCT01360632|141553894|SUPERIORITY_OR_OTHER||Ratio of response rate|1.41||||0.2873|TWO_SIDED|95.0|0.75|2.65|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.65|0.75|0.2873
71023304|NCT01360632|141553894|SUPERIORITY_OR_OTHER||Ratio of response rate|1.37||||0.2677|TWO_SIDED|95.0|0.79|2.36|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.36|0.79|0.2677
71023305|NCT01360632|141553894|SUPERIORITY_OR_OTHER||Ratio of response rate|1.8||||0.0031|TWO_SIDED|95.0|1.21|2.68|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.68|1.21|0.0031
71023306|NCT01360632|141553894|SUPERIORITY_OR_OTHER||Ratio of response rate|1.7||||0.0066|TWO_SIDED|95.0|1.15|2.5|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.50|1.15|0.0066
71023307|NCT01360632|141553894|SUPERIORITY_OR_OTHER||Ratio of response rate|1.34||||0.0665|TWO_SIDED|95.0|0.98|1.83|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.83|0.98|0.0665
71023308|NCT01360632|141553894|SUPERIORITY_OR_OTHER||Ratio of response rate|1.41||||0.025|TWO_SIDED|95.0|1.05|1.91|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.91|1.05|0.0250
71023309|NCT01360632|141553894|SUPERIORITY_OR_OTHER||Ratio of response rate|1.18||||0.2224|TWO_SIDED|95.0|0.9|1.54|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.54|0.90|0.2224
71023310|NCT01360632|141553894|SUPERIORITY_OR_OTHER||Ratio of response rate|1.31||||0.0369|TWO_SIDED|95.0|1.01|1.68|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.68|1.01|0.0369
71023311|NCT01360632|141553894|SUPERIORITY_OR_OTHER||Ratio of response rate|1.36||||0.0179|TWO_SIDED|95.0|1.05|1.75|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.75|1.05|0.0179
71023312|NCT01360632|141553894|SUPERIORITY_OR_OTHER||Ratio of response rate|1.49||||0.0011|TWO_SIDED|95.0|1.17|1.89|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.89|1.17|0.0011
70934197|NCT03924869|141369229|OTHER||Hazard Ratio (HR)|1.33||||0.93971|TWO_SIDED|95.0|0.93|1.9||1-sided p-value based on log-rank test stratified by Disease Stage, ECOG Performance Status, Geographic Region of Enrollment Site, and Reason For Not Receiving Surgery.|Log Rank|Per protocol, since the EFS null hypothesis was not rejected, the OS hypothesis was not formally tested and the p-value should be considered nominal.||"Hazard ratio and 95% CIs were based on Cox regression model with Efron's method of tie handling with treatment as a covariate, stratified by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason for Not Receiving Surgery (medically inoperable versus refused surgery)."||1.90|0.93|0.93971
70934198|NCT03924869|141369230|OTHER||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.74|1.42||Per protocol, there was no hypothesis pre-specified for TDDM to be formally tested.||||"Hazard ratio and 95% CIs were based on Cox regression model with Efron's method of tie handling with treatment as a covariate, stratified by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason for Not Receiving Surgery (medically inoperable versus refused surgery)."||1.42|0.74|
70934199|NCT03924869|141369233|OTHER||Mean Difference (Final Values)|-1.21||||0.5187|TWO_SIDED|95.0|-4.9|2.48|||cLDA model|||"Stats:~LS Mean change and 95% CIs were based on a constrained longitudinal data analysis (cLDA) model with the EORTC QLQ-C30 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery)."||2.48|-4.90|0.5187
70934200|NCT03924869|141369234|OTHER||Mean Difference (Final Values)|-4.34||||0.0906|TWO_SIDED|95.0|-9.38|0.69|||cLDA model|||LS Mean change and 95% CIs were based on a cLDA model with the EORTC QLQ-LC13 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery).||0.69|-9.38|0.0906
70934201|NCT03924869|141369235|OTHER||Mean Difference (Final Values)|1.24||||0.5482|TWO_SIDED|95.0|-2.83|5.31|||cLDA model|||LS Mean change and 95% CIs were based on a cLDA model with the EORTC QLQ-LC13 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery).||5.31|-2.83|0.5482
70934202|NCT03924869|141369236|OTHER||Mean Difference (Final Values)|-0.99||||0.7253|TWO_SIDED|95.0|-6.5|4.53|||cLDA model|||LS Mean change and 95% CIs were based on a cLDA model with the EORTC QLQ-C30 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery).||4.53|-6.50|0.7253
70934203|NCT03924869|141369237|OTHER||Mean Difference (Final Values)|-0.21||||0.9055|TWO_SIDED|95.0|-3.7|3.28|||cLDA model|||LS Mean change and 95% CIs were based on a cLDA model with the EORTC QLQ-C30 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery).||3.28|-3.70|0.9055
70941671|NCT04748445|141383934|OTHER||Slope|0.002902|STANDARD_ERROR_OF_MEAN|1.082||0.789|TWO_SIDED|90.0|-0.01503|0.02084|||Mixed Models Analysis|||MM\_MFCC std 07 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.02084|-0.01503|0.7890
71023313|NCT01360632|141553894|SUPERIORITY_OR_OTHER||Ratio of response rate|1.12||||0.3249|TWO_SIDED|95.0|0.89|1.41|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.41|0.89|0.3249
71023314|NCT01360632|141553894|SUPERIORITY_OR_OTHER||Ratio of response rate|1.33||||0.0122|TWO_SIDED|95.0|1.06|1.66|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.66|1.06|0.0122
71023315|NCT01360632|141553895|SUPERIORITY_OR_OTHER||Ratio of response rate|1.22||||0.5836|TWO_SIDED|95.0|0.6|2.49|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.49|0.60|0.5836
71023316|NCT01360632|141553895|SUPERIORITY_OR_OTHER||Ratio of response rate|1.31||||0.3792|TWO_SIDED|95.0|0.73|2.37|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.37|0.73|0.3792
71023317|NCT01360632|141553895|SUPERIORITY_OR_OTHER||Ratio of response rate|1.77||||0.0101|TWO_SIDED|95.0|1.14|2.74|||Ratio of response rate|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.74|1.14|0.0101
71023318|NCT01360632|141553895|SUPERIORITY_OR_OTHER||Ratio of response rate|1.75||||0.0065|TWO_SIDED|95.0|1.17|2.63|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.63|1.17|0.0065
70934204|NCT02542943|141369238|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-0.13||||0.435|TWO_SIDED|95.0|-0.4|0.134||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. For the Week 8 comparisons of the two test groups against the control group, Dunnett's multiplicity adjustment is applied.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment. For Week 8 comparisons of the two test groups against the control group, Dunnett's multiplicity adjustment is applied.|||0.134|-0.400|0.4350
70934205|NCT02542943|141369238|SUPERIORITY_OR_OTHER||LS mean difference|0.07||||0.7605|TWO_SIDED|95.0|-0.192|0.34||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. For the Week 8 comparisons of the two test groups against the control group, Dunnett's multiplicity adjustment is applied.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment. For Week 8 comparisons of the two test groups against the control group, Dunnett's multiplicity adjustment is applied.|||0.340|-0.192|0.7605
70934206|NCT02542943|141369239|SUPERIORITY_OR_OTHER||LS mean difference|-0.21||||0.0873|TWO_SIDED|95.0|-0.445|0.031||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.031|-0.445|0.0873
70934207|NCT02542943|141369240|SUPERIORITY_OR_OTHER||LS mean difference|-0.07||||0.4921|TWO_SIDED|95.0|-0.27|0.13||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.130|-0.270|0.4921
70934208|NCT02542943|141369240|SUPERIORITY_OR_OTHER||LS mean difference|0.02||||0.8728|TWO_SIDED|95.0|-0.183|0.216||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.216|-0.183|0.8728
70934209|NCT02542943|141369240|SUPERIORITY_OR_OTHER||LS mean difference|-0.09||||0.4003|TWO_SIDED|95.0|-0.287|0.115||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.115|-0.287|0.4003
70934210|NCT02542943|141369241|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.8106|TWO_SIDED|95.0|0.0|0.0||From Van Elteren test.|Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||0.000|0.000|0.8106
70934211|NCT02542943|141369241|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.1656|TWO_SIDED|95.0|-5.0|0.0||From Van Elteren test.|Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||0.000|-5.000|0.1656
70934212|NCT02542943|141369241|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.1419|TWO_SIDED|95.0|0.0|5.0|||Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||5.000|0.000|0.1419
71023319|NCT01360632|141553895|SUPERIORITY_OR_OTHER||Ratio of response rate|1.41||||0.0526|TWO_SIDED|95.0|1.0|1.99|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.99|1.00|0.0526
71023320|NCT01360632|141553895|SUPERIORITY_OR_OTHER||Ratio of response rate|1.51||||0.0156|TWO_SIDED|95.0|1.08|2.11|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.11|1.08|0.0156
71023321|NCT01360632|141553895|SUPERIORITY_OR_OTHER||Ratio of response rate|1.22||||0.1689|TWO_SIDED|95.0|0.92|1.63|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.63|0.92|0.1689
71023322|NCT01360632|141553895|SUPERIORITY_OR_OTHER||Ratio of response rate|1.37||||0.0231|TWO_SIDED|95.0|1.04|1.8|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.80|1.04|0.0231
71023323|NCT01360632|141553895|SUPERIORITY_OR_OTHER||Ratio of response rate|1.4||||0.0175|TWO_SIDED|95.0|1.06|1.84|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.84|1.06|0.0175
71023324|NCT01360632|141553895|SUPERIORITY_OR_OTHER||Ratio of response rate|1.59||||0.0004|TWO_SIDED|95.0|1.22|2.07|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.07|1.22|0.0004
71023325|NCT01360632|141553895|SUPERIORITY_OR_OTHER||Ratio of response rate|1.21||||0.1396|TWO_SIDED|95.0|0.94|1.55|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.55|0.94|0.1396
71056863|NCT02800642|141618406|OTHER||||||=|0.8822|||||||Exact one-sided 1-sample binomial test|||"The null hypothesis the proportion of participants with a mean treatment interval of ≥ 8 weeks is ≤ 50% on the 2.5% level of significance (one-sided) was performed using the following criterion: If the p value is less than 2.5%, the null hypothesis will be rejected. Otherwise, the null hypothesis will be regarded as not rejected and may still be true"||||=0.8822
71107966|NCT02949011|141721539|SUPERIORITY|||||||0.0265||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.0265
70934213|NCT02542943|141369242|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.5631|TWO_SIDED|95.0|0.0|5.0||From Van Elteren test.|Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||5.000|0.000|0.5631
70934214|NCT02542943|141369242|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.8423|TWO_SIDED|95.0|0.0|0.0||From Van Elteren test.|Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||0.000|0.000|0.8423
70934215|NCT02542943|141369242|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.439|TWO_SIDED|95.0|0.0|5.0||From Van Elteren test.|Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||5.000|0.000|0.4390
71023326|NCT01360632|141553895|SUPERIORITY_OR_OTHER||Ratio of response rate|1.46||||0.0016|TWO_SIDED|95.0|1.15|1.86|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.86|1.15|0.0016
71023327|NCT02462382|141553897|EQUIVALENCE|The univariate analyses were conducted using Independent t-Tests for continuous variables and Fisher Exact Tests or Chi-Square Tests of Independence for categorical comparisons.|Fisher Exact Tests|0.041||||0.006|TWO_SIDED|||||POD 1 1cm incision.|Chi-squared|||Comparisons of pain scores using a Visual Analog Scale (VAS) based on Post-Operative Day (POD).||||.006
71023328|NCT01084005|141553901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.81|-0.48|||ANCOVA|||||-0.48|-0.81|<0.0001
71023329|NCT01084005|141553902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.45|-0.24|||ANCOVA|||||-0.24|-0.45|<0.0001
71023330|NCT01084005|141553903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|-0.71|-0.43|||ANCOVA|||||-0.43|-0.71|<0.0001
71023331|NCT01084005|141553904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.77|-0.47|||ANCOVA|||||-0.47|-0.77|<0.0001
71023332|NCT01084005|141553905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.7|STANDARD_ERROR_OF_MEAN|4.8|<|0.0001||95.0|-30.2|-11.2|||ANCOVA|||||-11.2|-30.2|<0.0001
71023333|NCT01084005|141553906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.6|STANDARD_ERROR_OF_MEAN|3.1|<|0.0001||95.0|-24.7|-12.6|||Mixed Models Analysis|||||-12.6|-24.7|<0.0001
71023334|NCT01084005|141553907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.5|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-28.1|-14.8|||Mixed Models Analysis|||||-14.8|-28.1|<0.0001
71023335|NCT01084005|141553908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.6|STANDARD_ERROR_OF_MEAN|4.2|<|0.0001||95.0|-29.8|-13.4|||Mixed Models Analysis|||||-13.4|-29.8|<0.0001
71023336|NCT01084005|141553909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.319|||<|0.0001||95.0|3.321|20.837|||Regression, Logistic|||||20.837|3.321|<0.0001
71023337|NCT01084005|141553912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.214||||0.0048|TWO_SIDED|95.0|0.073|0.625|||Regression, Logistic|||Lina 5 mg qd vs Placebo||0.625|0.073|0.0048
71023338|NCT02967133|141553943|SUPERIORITY|||||||0.5186|||||||Log Rank|||||||0.5186
71023339|NCT01034137|141553944|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.996|||<|0.001|TWO_SIDED|95.0|1.589|2.506|||Cochran-Mantel-Haenszel|||The SRR was compared between the treatment groups by means of the Cochran-Mantel-Haenszel (CMH) test taking into account the stratification factors used for randomization.||2.506|1.589|< 0.001
71023340|NCT01034137|141553944|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.855|||<|0.001|TWO_SIDED|95.0|1.481|2.323|||Cochran-Mantel-Haenszel|||The SRR was compared between the treatment groups by means of the CMH test taking into account the stratification factors used for randomization.||2.323|1.481|< 0.001
71023341|NCT01034137|141553944|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||0.616|TWO_SIDED|95.0|0.915|1.16|||Cochran-Mantel-Haenszel|||The SRR was compared between the treatment groups by means of the CMH test taking into account the stratification factors used for randomization.||1.160|0.915|0.616
71023342|NCT00936377|141553986|SUPERIORITY_OR_OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
71023343|NCT00936377|141553986|SUPERIORITY_OR_OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
71023344|NCT00936377|141553987|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71023345|NCT00936377|141553987|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71023346|NCT00936377|141553988|SUPERIORITY_OR_OTHER|||||||0.066|||||||Wilcoxon (Mann-Whitney)|||||||0.066
71023347|NCT00936377|141553988|SUPERIORITY_OR_OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
71023348|NCT00936377|141553989|SUPERIORITY_OR_OTHER|||||||0.18||||||Percentage of CIWA scores rates as severe|Chi-squared, Corrected|||Percentage of CIWA scores rates as severe||||0.18
71023349|NCT00936377|141553989|SUPERIORITY_OR_OTHER|||||||0.35||||||Percentage of CIWA scores rates as severe|Chi-squared, Corrected|||||||0.35
71023350|NCT00936377|141553990|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||For hypotension||||1
71023351|NCT00936377|141553990|SUPERIORITY_OR_OTHER|||||||0.47|||||||Fisher Exact|||For hypotension||||0.47
71023352|NCT00936377|141553990|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||For bradycardia||||1
71023353|NCT00936377|141553990|SUPERIORITY_OR_OTHER|||||||0.2|||||||Fisher Exact|||For bradycardia||||0.2
71056864|NCT02027428|141618414|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.3486|TWO_SIDED|95.0|0.61|1.19||Stratification factors evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at end of Induction.|stratified log-rank test||Hazard ratio: nab-paclitaxel + BSC / BSC Alone|5% level of significance. Hazard ratio is based on stratified Cox proportional hazards regression model. The following stratification factors were evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at the end of Induction.||1.19|0.61|0.3486
71023354|NCT00936377|141553991|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Repeated measures ANOVA|||||||<0.05
71023355|NCT00936377|141553992|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
71023356|NCT00936377|141553992|SUPERIORITY_OR_OTHER|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
70934216|NCT02542943|141369243|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.517|TWO_SIDED|95.0|-0.611|0.308||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.308|-0.611|0.5170
70934217|NCT02542943|141369243|SUPERIORITY_OR_OTHER||LS mean difference|0.17||||0.4538|TWO_SIDED|95.0|-0.284|0.633||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.633|-0.284|0.4538
70934218|NCT02542943|141369243|SUPERIORITY_OR_OTHER||LS mean difference|-0.33||||0.1663|TWO_SIDED|95.0|-0.788|0.136||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.136|-0.788|0.1663
70934219|NCT02542943|141369244|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.7137|TWO_SIDED|95.0|-0.661|0.453||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.453|-0.661|0.7137
70934220|NCT02542943|141369244|SUPERIORITY_OR_OTHER||LS mean difference|0.1||||0.7353|TWO_SIDED|95.0|-0.46|0.651||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.651|-0.460|0.7353
70934221|NCT02542943|141369244|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.4843|TWO_SIDED|95.0|-0.76|0.361||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.361|-0.760|0.4843
70934222|NCT02823028|141369277|SUPERIORITY||Odds Ratio (OR)|0.931||||0.779|TWO_SIDED||||||Chi-squared|||||||.779
70934223|NCT01836445|141369286|SUPERIORITY||Prevalence Ratio|0.9||||0.2|TWO_SIDED|95.0|0.76|1.06|||Regression, Logistic|||||1.06|0.76|0.20
71023357|NCT00936377|141553993|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
71023358|NCT00936377|141553993|SUPERIORITY_OR_OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
71023359|NCT01764854|141553994|SUPERIORITY|||||||0.46|||||||ANCOVA|||AZD1722 in-patient and Placebo in-patient are not included in this analysis since it was only a one week evaluation period and an effect was not expected. Also the size (n=8) of the group was too small to .perform this analysis.||||0.46
71023360|NCT01764854|141553995|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||AZD1722 out-patient and Placebo out-patient were not included in this analysis since stool was only collected in the clinical pharmacology unit of the in-patient groups.||||<0.0001
71023361|NCT02555618|141554059|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|1.7|||||TWO_SIDED|95.0|-7.983|11.415|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for A/H1N1 Strain-Day 22.||11.415|-7.983|
71023362|NCT02555618|141554059|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|-4.8|||||TWO_SIDED|95.0|-13.974|4.403|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for A/H3N2 Strain-Day 22.||4.403|-13.974|
71023363|NCT02555618|141554059|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|2.6|||||TWO_SIDED|95.0|-6.082|11.32|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for B Strain-Day 22.||11.320|-6.082|
71023364|NCT02555618|141554060|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|0.99|||||TWO_SIDED|95.0|0.7984|1.2253|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H1N1 Strain-Day 22.||1.2253|0.7984|
71023365|NCT02555618|141554060|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|0.76|||||TWO_SIDED|95.0|0.5544|1.05|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H3N2 Strain-Day 22.||1.0500|0.5544|
71023366|NCT02555618|141554060|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.06|||||TWO_SIDED|95.0|0.8134|1.3931|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for B Strain-Day 22.||1.3931|0.8134|
70934224|NCT01836445|141369287|SUPERIORITY||Prevalence Ratio|0.95||||0.6|TWO_SIDED|95.0|0.8|1.14|||Regression, Logistic|||||1.14|0.80|0.60
70934225|NCT01836445|141369288|SUPERIORITY||Prevalence Ratio|0.83||||0.04|TWO_SIDED|95.0|0.7|0.99|||Regression, Logistic|||||0.99|0.70|0.04
70934226|NCT01836445|141369290|SUPERIORITY||Risk Ratio (RR)|0.6||||0.01|TWO_SIDED|95.0|0.38|0.95|||Z-test|||||0.95|0.38|0.01
70934227|NCT01836445|141369291|OTHER|Generalized Linear Mixed Model statistical test used||||||0.15|||||||Regression, Linear|||||||0.150
70934228|NCT01836445|141369292|OTHER|Generalized Linear Mixed Model statistical test used||||||0.374|||||||Regression, Linear|||||||0.374
70934229|NCT01836445|141369293|OTHER|Generalized Linear Mixed Model statistical test used||||||0.919|||||||Regression, Linear|||Analysis for Motivation items||||0.919
70934230|NCT01836445|141369293|OTHER|Generalized Linear Mixed Model statistical test used||||||0.493|||||||Regression, Linear|||Analysis for Social Norms items||||0.493
70934231|NCT01836445|141369293|OTHER|Generalized Linear Mixed Model statistical test used||||||0.002|||||||Regression, Linear|||Analysis for Behavioral Skills items||||0.002
70934232|NCT01836445|141369294|OTHER|Generalized Linear Mixed Model statistical test used||||||0.067|||||||Regression, Linear|||Analysis for Relationship Maintenance items||||0.067
70934233|NCT01836445|141369294|OTHER|Generalized Linear Mixed Model statistical test used||||||0.135|||||||Regression, Linear|||Analysis for Condom Use items||||0.135
71023367|NCT02555618|141554063|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|6.8|||||TWO_SIDED|95.0|-3.02|16.348||||||The analysis is difference of seroconversion rate between treatment groups for A/H1N1 Strain-Day 22.||16.348|-3.020|
71023368|NCT02555618|141554063|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|-8.8|||||TWO_SIDED|95.0|-18.282|0.901||||||The analysis is difference of seroconversion rate between treatment groups for A/H3N2 Strain-Day 22.||0.901|-18.282|
71056865|NCT02027428|141618415|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0365|TWO_SIDED|95.0|0.47|0.98||Stratification factors evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at end of Induction.|stratified log-rank test||Hazard ratio: nab-paclitaxel + BSC / BSC Alone|5% level of significance. Hazard ratio is based on stratified Cox proportional hazards regression model. The following stratification factors were evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at the end of Induction.||0.98|0.47|0.0365
71056866|NCT02027428|141618416|SUPERIORITY||Overall response rate ratio|1.2||||0.087|TWO_SIDED|95.0|0.948|1.519||Stratification factors evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at the end of Induction, and tumor response (CR/PR or SD) at the end of Induction.|Cochran-Mantel-Haenszel||response ratio: nab-paclitaxel + BSC / BSC Alone|5% level of significance. The rate ratio and its 95% CI were based on the non-stratified analysis.||1.519|0.948|0.0870
71056867|NCT02027428|141618417|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.4164|TWO_SIDED|95.0|0.62|1.22||Stratification factors evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at end of Induction.|stratified log-rank test||Hazard ratio: nab-paclitaxel + BSC / BSC Alone|5% level of significance. Hazard ratio is based on stratified Cox proportional hazards regression model. The following stratification factors were evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at the end of Induction.||1.22|0.62|0.4164
71107967|NCT02949011|141721539|SUPERIORITY|||||||0.0247||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.0247
71023369|NCT02555618|141554063|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|-2.3|||||TWO_SIDED|95.0|-11.461|6.835||||||The analysis is difference of seroconversion rate between treatment groups for B Strain-Day 22.||6.835|-11.461|
71023370|NCT02555618|141554064|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.05|||||TWO_SIDED|95.0|0.9559|1.1473|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H1N1 Strain-Day 22.||1.1473|0.9559|
71023371|NCT02555618|141554064|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|0.9|||||TWO_SIDED|95.0|0.7862|1.0241|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H3N2 Strain-Day 22.||1.0241|0.7862|
71023372|NCT02555618|141554064|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|0.98|||||TWO_SIDED|95.0|0.9273|1.0364|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for B Strain-Day 22.||1.0364|0.9273|
71023373|NCT02555618|141554067|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|14.7|||||TWO_SIDED|95.0|5.489|23.577||||||The analysis is difference of seroconversion rate between treatment groups for A/H1N1 Strain-Day 22.||23.577|5.489|
71023374|NCT02555618|141554067|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|-1.9|||||TWO_SIDED|95.0|-10.614|6.928||||||The analysis is difference of seroconversion rate between treatment groups for A/H3N2 Strain-Day 22.||6.928|-10.614|
71023375|NCT02555618|141554067|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|-2.4|||||TWO_SIDED|95.0|-10.346|5.579||||||The analysis is difference of seroconversion rate between treatment groups for B-Strain.||5.579|-10.346|
71023376|NCT02555618|141554068|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.48|||||TWO_SIDED|95.0|1.1221|1.9623|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H1N1 Strain-Day 22.||1.9623|1.1221|
71107968|NCT02949011|141721539|SUPERIORITY|||||||0.5298||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.5298
71107969|NCT02949011|141721539|SUPERIORITY|||||||0.9554||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.9554
71023377|NCT02555618|141554068|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.07|||||TWO_SIDED|95.0|0.7806|1.4564|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H3N2 Strain-Day 22.||1.4564|0.7806|
71023378|NCT02555618|141554068|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.07|||||TWO_SIDED|95.0|0.8166|1.3934|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for B Strain-Day 22.||1.3934|0.8166|
71023379|NCT02555618|141554071|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|1.1|||||TWO_SIDED|95.0|-7.195|9.423|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for A/H1N1 Strain-Day 22.||9.423|-7.195|
71023380|NCT02555618|141554071|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|-0.8|||||TWO_SIDED|95.0|-10.369|8.803|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for A/H3N2 Strain-Day 22.||8.803|-10.369|
71023381|NCT02555618|141554071|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|3.2|||||TWO_SIDED|95.0|-6.406|12.757|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for B Strain-Day 22.||12.757|-6.406|
71023382|NCT02555618|141554072|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.07|||||TWO_SIDED|95.0|0.9106|1.2484|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H1N1 Strain-Day 22.||1.2484|0.9106|
71023383|NCT02555618|141554072|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|0.98|||||TWO_SIDED|95.0|0.8686|1.0969|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H3N2-Day 22.||1.0969|0.8686|
71023384|NCT02555618|141554072|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.05|||||TWO_SIDED|95.0|0.9622|1.1427|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for B Strain-Day 22.||1.1427|0.9622|
71023385|NCT02063698|141554078|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 2: BPI Worst Pain Past 24 Hours||||1.0
71023386|NCT02063698|141554078|SUPERIORITY|||||||0.45|||||||Fisher Exact|||Day 3: BPI Worst Pain Past 24 Hours||||0.45
71023387|NCT02063698|141554078|SUPERIORITY|||||||0.38|||||||Fisher Exact|||Day 4: BPI Worst Pain Past 24 Hours||||0.38
71056868|NCT02027428|141618418|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0381|TWO_SIDED|95.0|0.47|0.98||Stratification factors evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at end of Induction.|stratified log-rank test||Hazard ratio: nab-paclitaxel + BSC / BSC Alone|5% level of significance. Hazard ratio is based on stratified Cox proportional hazards regression model. The following stratification factors were evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at the end of Induction.||0.98|0.47|0.0381
70934234|NCT01836445|141369294|OTHER|Generalized Linear Mixed Model statistical test used||||||0.025|||||||Regression, Linear|||Analysis for HIV Testing items||||0.025
71023388|NCT02063698|141554078|SUPERIORITY|||||||0.12|||||||Fisher Exact|||Day 5: BPI Worst Pain Past 24 Hours||||0.12
71023389|NCT02063698|141554078|SUPERIORITY|||||||0.7|||||||Fisher Exact|||Day 6: BPI Worst Pain Past 24 Hours||||0.70
71023390|NCT02063698|141554078|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 7: BPI Worst Pain Past 24 Hours||||1.0
71023391|NCT02063698|141554078|SUPERIORITY|||||||0.44|||||||Fisher Exact|||Day 8: BPI Worst Pain Past 24 Hours||||0.44
71023392|NCT02063698|141554079|SUPERIORITY|||||||0.44|||||||Equal variance t-test|||||||0.44
71023393|NCT02063698|141554080|SUPERIORITY|||||||0.13|||||||Equal variance t-test|||||||0.13
71023394|NCT02063698|141554082|SUPERIORITY|||||||0.025|||||||Chi-squared|||||||0.025
71023395|NCT02063698|141554083|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
71023396|NCT02063698|141554084|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||0.02
71023397|NCT02063698|141554085|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
71023398|NCT02063698|141554086|SUPERIORITY|||||||0.04|||||||Chi-squared|||||||0.04
71023399|NCT00410410|141554087|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.73||||0.124|TWO_SIDED|95.0|0.48|1.09||Cochran-Mantel-Haenszel Chi square p-value and RR along with 95% confidence interval provided, adjusting for randomization strata (whether a participant had an inadequate response and/or intolerance to anti-TNF therapy).|Cochran-Mantel-Haenszel|Conditional on ABA 30/\~10 mg/kg vs PLA comparison being statistically significant at 5% level, ABA \~10 vs PLA to be tested at 5% significance level.||Null hypothesis=no treatment difference between ABA arm and placebo (PLA) arm. ABA 30/\~10 mg/kg vs PLA: power=98%, sample size=140 per arm,expected PLA response rate=40%, ABA 30/\~10 mg/kg=65%. ABA \~10 mg/kg vs. PLA: power=90%, sample size=140 per arm, 5% significance; expected PLA response rate= 40%, ABA \~10=60%.||1.09|0.48|0.124
71023400|NCT00410410|141554089|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.2|||||TWO_SIDED|95.0|0.06|0.67||Cochran-Mantel-Haenszel Chi square p-value and RR along with 95% confidence interval provided, adjusting for randomization strata.|Cochran-Mantel-Haenszel|Conditional on ABA 30/\~10 vs PLA comparison for clinical response being significant at 5% level, this comparison for remission will be tested at 5%.|Conditional on both the remission comparison for ABA 30/\~10 vs PLA, and the clinical response comparison for ABA\~10 vs PLA being significant at 5%, the secondary remission comparison for ABA \~10 vs PLA will be tested at 5%.|Null hypothesis=no treatment difference between each of the ABA and placebo (PLA). At 5% significance level, Aba 30/\~10 vs. PLA: power=96%, sample size=140 per arm, expected PLA rate=15%. ABA 30/\~10 =35%; Aba \~10 vs. PLA: power=82%, sample size=140 per arm, expected PLA response rate= 15%, ABA/\~10 mg/kg=30%||0.67|.06|
71023401|NCT00410410|141554090|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.66|||||TWO_SIDED|95.0|0.42|1.05||Cochran-Mantel-Haenszel Chi square p-value and RR along with 95% confidence interval provided, adjusting for randomization strata.|Cochran-Mantel-Haenszel|If ABA 30/\~10 vs PLA remission comparison is significant at 5% level, the mucosal healing comparison for the same treatment group will be tested at 5%|Conditional on both the comparison for mucosal healing for ABA 30/\~10 vs PLA and the comparison for remission for ABA \~10 vs. PLA being significant, the comparison for mucosal healing for ABA \~10 vs PLA will be tested at 5%.|Null hypothesis=no treatment difference (relative risk \[RR\] of ABA over placebo=1) for mucosal healing. ABA 30/\~10 vs. placebo: power=99%, sample size=140 per arm, expected PLA response rate=30%, ABA 30/\~10 mg/kg=60%. ABA \~10 vs. placebo: power=98%, sample size=140 per arm, 5% significance; expected PLA response rate= 30%, ABA \~10 mg/kg=55%||1.05|0.42|
71023402|NCT00410410|141554091|SUPERIORITY_OR_OTHER|||||||0.044||||||All statistical testing was performed at a pre-specified alpha-level of 5%.|Cochran-Armitage Trend Test|||The Cochran-Armitage trend test was performed to evaluate whether a relationship existed between the response and dose regimen by comparing the proportion of participants in response across all four treatment arms.||||0.044
71023403|NCT00410410|141554097|SUPERIORITY_OR_OTHER|||||||0.149||||||All statistical testing was performed at a pre-specified alpha-level of 5%|Cochran-Armitage Trend Test|||The Cochran-Armitage trend test was performed to evaluate whether a relationship existed between the response and dose regimen by comparing the proportion of participants in response across all four treatment arms. Normal approximation was used if the number of responses in a treatment group is at least 5. Otherwise an exact method was used.||||0.149
71023404|NCT01271933|141554174|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0186|TWO_SIDED|||||The p-value was calculated using log-rank test for comparing pregabalin CR with placebo|Log Rank|||||||0.0186
71023405|NCT01271933|141554178|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.41||0.331|TWO_SIDED|95.0|-1.2|0.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model|ANCOVA|||||0.4|-1.2|0.3310
71023406|NCT01271933|141554181|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.4||0.9247|TWO_SIDED|95.0|-0.8|0.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||0.8|-0.8|0.9247
71023407|NCT01271933|141554190|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|7.12||0.4314|TWO_SIDED|95.0|-19.7|8.5||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model|ANCOVA|||This analysis is for the domain: Subjective Wake after Sleep Onset||8.5|-19.7|0.4314
71023408|NCT01271933|141554190|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|9.26||0.8915|TWO_SIDED|95.0|-17.1|19.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Subjective Latency to Sleep Onset||19.6|-17.1|0.8915
71023409|NCT01271933|141554191|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.41||0.4571|TWO_SIDED|95.0|-0.5|1.1||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||1.1|-0.5|0.4571
71023410|NCT01271933|141554192|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3779|TWO_SIDED|95.0|-0.2|0.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||0.6|-0.2|0.3779
71023411|NCT01271933|141554193|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.34||0.2009|TWO_SIDED|95.0|-0.2|1.1||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||1.1|-0.2|0.2009
70934235|NCT01836445|141369295|OTHER|Generalized Linear Mixed Model statistical test used||||||0.138|||||||Regression, Logistic|||||||0.138
70934236|NCT01836445|141369296|OTHER|Generalized Linear Mixed Model statistical test used||||||0.173|||||||Regression, Linear|||||||0.173
70934237|NCT01836445|141369297|OTHER|Generalized Linear Mixed Model statistical test used||||||0.567|||||||Regression, Linear|||||||0.567
70934238|NCT01836445|141369298|OTHER|Generalized Linear Mixed Model statistical test used||||||0.861|||||||Regression, Linear|||Analysis for motivation items||||0.861
71023412|NCT01271933|141554195|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.48||0.1845|TWO_SIDED|95.0|-1.6|0.3||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||0.3|-1.6|0.1845
71056869|NCT02027428|141618419|SUPERIORITY||Overall response rate ratio|3.15||||0.0978|TWO_SIDED|95.0|0.733|13.574||5% level of significance.|Cochran-Mantel-Haenszel||Response rate ratio: nab-paclitaxel + BSC / BSC Alone|||13.574|0.733|0.0978
71056870|NCT02027428|141618420|SUPERIORITY||disease control rate ratio|0.99|||||TWO_SIDED|95.0|0.978|1.007|||||Disease control rate ratio: nab-paclitaxel + BSC / BSC Alone|The rate ratio and its 95% confidence interval are based on non-stratified analysis.||1.007|0.978|
71107970|NCT02949011|141721539|SUPERIORITY|||||||0.9075||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.9075
71056871|NCT02027428|141618422|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.59|1.47|||||Hazard ratio: nab-paclitaxel + BSC / BSC Alone|Hazard ratio was based on stratified Cox proportional hazards regression model. The following stratification factors were evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at the end of Induction, and tumor response (CR/PR or SD) at the end of Induction.||1.47|0.59|
70934239|NCT01836445|141369298|OTHER|Generalized Linear Mixed Model statistical test used||||||0.628|||||||Regression, Linear|||Analysis for social norms items||||0.628
70934240|NCT01836445|141369298|OTHER|Generalized Linear Mixed Model statistical test used||||||0.151|||||||Regression, Linear|||Analysis for behavioral skills items||||0.151
70934241|NCT01836445|141369299|OTHER|Generalized Linear Mixed Model statistical test used||||||0.001|||||||Regression, Linear|||Analysis for Relationship Maintenance items||||0.001
70934242|NCT01836445|141369299|OTHER|Generalized Linear Mixed Model statistical test used||||||0.067|||||||Regression, Linear|||Analysis for Condom Use items||||0.067
70934243|NCT01836445|141369299|OTHER|Generalized Linear Mixed Model statistical test used||||||0.637|||||||Regression, Linear|||Analysis for HIV Testing items||||0.637
70934244|NCT01836445|141369300|OTHER|Generalized Linear Mixed Model statistical test used||||||0.862|||||||Regression, Linear|||||||0.862
70934245|NCT01836445|141369301|OTHER|Generalized Linear Mixed Model statistical test used||||||0.762|||||||Regression, Linear|||||||0.762
70934246|NCT01836445|141369302|SUPERIORITY|||||||0.043|||||||Regression, Linear|||Analysis for Motivation items||||0.043
70934247|NCT01836445|141369302|SUPERIORITY|||||||0.617|||||||Regression, Linear|||Analysis for Social Norm items||||0.617
70934248|NCT01836445|141369302|SUPERIORITY|||||||0.57|||||||Regression, Linear|||Analysis for Behavioral Skills items||||0.570
70934249|NCT01836445|141369303|SUPERIORITY|||||||0.036|||||||Regression, Linear|||Analysis for Relationship Maintenance items||||0.036
70934250|NCT01836445|141369303|SUPERIORITY|||||||0.837|||||||Regression, Linear|||Analysis for Condom Use items||||0.837
71023413|NCT01271933|141554198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.9|STANDARD_ERROR_OF_MEAN|4.52||0.0305|TWO_SIDED|95.0|-18.9|1.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Sleep disturbance||1.0|-18.9|0.0305
71023414|NCT01271933|141554198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|5.17||0.3133|TWO_SIDED|95.0|-5.0|15.5||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Snoring||15.5|-5.0|0.3133
71023415|NCT01271933|141554198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|3.71||0.2985|TWO_SIDED|95.0|-11.2|3.5||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Awakening Short of Breath or with a Headache||3.5|-11.2|0.2985
71056872|NCT00517556|141618425|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71056873|NCT02682927|141618491|SUPERIORITY||Percentage difference from Placebo|62.29|||||TWO_SIDED|95.0|47.72|72.8|||||Estimate was obtained from the LSMeans on the log scale as follows: 100 x \[1 - exp(LS mean active - LS mean placebo).|||72.80|47.72|
71056874|NCT02682927|141618491|SUPERIORITY||Percentage difference from Placebo|64.75|||||TWO_SIDED|95.0|51.85|74.19|||||Estimate was obtained from the LSMeans on the log scale as follows: 100 x \[1 - exp(LS mean active - LS mean placebo).|||74.19|51.85|
71056875|NCT02682927|141618492|SUPERIORITY||Percentage difference from Placebo|32.43|||||TWO_SIDED|95.0|6.19|51.33|||||Estimate was obtained from the LSMeans on the log scale as follows: 100 x \[1 - exp(LS mean active - LS mean placebo).|||51.33|6.19|
71056876|NCT02682927|141618492|SUPERIORITY||Percentage difference from Placebo|49.88|||||TWO_SIDED|95.0|31.31|63.43|||||Estimate was obtained from the LSMeans on the log scale as follows: 100 x \[1 - exp(LS mean active - LS mean placebo).|||63.43|31.31|
71056877|NCT02682927|141618494|SUPERIORITY||Odds Ratio (OR)|4.773||||0.009|TWO_SIDED|95.0|1.475|15.45|||Regression, Logistic|||||15.450|1.475|0.009
71056878|NCT02682927|141618494|SUPERIORITY||Odds Ratio (OR)|14.96|||<|0.001|TWO_SIDED|95.0|4.484|49.915|||Regression, Logistic|||||49.915|4.484|<0.001
71056879|NCT02682927|141618494|SUPERIORITY||Odds Ratio (OR)|13.4||||0.0001|TWO_SIDED|95.0|3.6|49.8|||Regression, Logistic|||||49.8|3.6|0.0001
71056880|NCT02682927|141618494|SUPERIORITY||Odds Ratio (OR)|53.3|||<|0.0001|TWO_SIDED|95.0|12.9|220.5|||Regression, Logistic|||||220.5|12.9|<0.0001
71056881|NCT02682927|141618497|SUPERIORITY|||||||0.035|||||||Wilcoxon rank sum test|||||||0.035
71056882|NCT02682927|141618497|SUPERIORITY||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
71056883|NCT02682927|141618497|SUPERIORITY||Comparing active with placebo|||||0.0002|||||||Wilcoxon rank sum test|||||||0.0002
70934251|NCT01836445|141369303|SUPERIORITY|||||||0.953|||||||Regression, Linear|||Analysis for HIV Testing items||||0.953
71056884|NCT02682927|141618497|SUPERIORITY||||||<|0.0001|||||||Wilcoxon rank sum test|||||||<0.0001
71056885|NCT00676780|141618516|SUPERIORITY_OR_OTHER||||||=|0.027||95.0|||||Wilcoxon (Mann-Whitney)|||||||=0.027
71056886|NCT00676780|141618517|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.023
71056887|NCT00676780|141618518|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||Null hypothesis is no change, i.e. median change = 0.0||||<0.001
71056888|NCT01613313|141618519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.0|||||TWO_SIDED|||||||No p value||This is a proof of concept dose escalation study. No power justification has been implemented. Descriptive data provided for each arm.||||
71056889|NCT01613313|141618520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.0|||||TWO_SIDED|||||||||This is a proof of concept dose escalation study. No power of justification was implemented. Descriptive statistics was provided for each arm only.||||
71056890|NCT02766283|141618526|SUPERIORITY_OR_OTHER|||||||0.9|||||||Chi-squared|||||||0.90
71056891|NCT02766283|141618527|SUPERIORITY_OR_OTHER|||||||0.022|||||||Chi-squared|||||||0.022
71056892|NCT04007991|141618534|SUPERIORITY||Difference in Least Square Mean|-3.44|STANDARD_ERROR_OF_MEAN|1.351|=|0.011|TWO_SIDED|95.0|-6.09|-0.79||Change from baseline in YGTSS score as a continuous variable was based on mixed model for repeated measures (MMRM) analysis of covariance (ANCOVA) model with an unstructured covariance matrix.|ANCOVA|||||-0.79|-6.09|=0.011
71056893|NCT03888066|141618546|SUPERIORITY||Mean Difference (Final Values)|-0.097|STANDARD_ERROR_OF_MEAN|0.015|<|0.001|TWO_SIDED|95.0|-0.128|-0.067|||Mixed model for repeated measures (MMRM)|||Difference in adjusted mean changes (SE)||-0.067|-0.128|< 0.001
71056894|NCT03888066|141618547|SUPERIORITY||Hazard Ratio (HR)|0.63|||=|0.006|TWO_SIDED|95.0|0.45|0.87||Threshold for statistical significance = 0.05|Regression, Cox|||"Hazard Ratio patiromer vs placebo.~The HR for the time to first hyperkalemia event for patiromer vs placebo was calculated. HR and p-value come from a Cox proportional regression model adjusted for geographic region, sex, Baseline T2DM status, Baseline K+ value, and Baseline eGFR.~HR = Hazard Ratio; T2DM=Type 2 diabetes mellitus; eGFR=Estimated glomerular filtration rate"||0.87|0.45|= 0.006
70934252|NCT01836445|141369304|SUPERIORITY|||||||0.719|||||||Regression, Linear|||||||0.719
71056895|NCT03888066|141618548|SUPERIORITY||Hazard Ratio (HR)|0.62|||=|0.006|TWO_SIDED|95.0|0.45|0.87||Threshold for statistical significance = 0.05|Regression, Cox|||"Hazard Ratio patiromer vs placebo.~The HR for the time to first hyperkalemia event for patiromer vs placebo was calculated. HR and p-value come from a Cox proportional regression model adjusted for geographic region, sex, Baseline T2DM status, Baseline K+ value, and Baseline eGFR.~HR = Hazard Ratio; T2DM=Type 2 diabetes mellitus; eGFR=Estimated glomerular filtration rate"||0.87|0.45|= 0.006
71056896|NCT03888066|141618549|SUPERIORITY||Annualized event rate ratio|0.658|||<|0.001|TWO_SIDED|95.0|0.534|0.81|||Negative binomial model adjusted for cov|||"NBMAC Annualized event RR patiromer vs placebo.~NBMAC adjusted for geographical region, sex, Baseline T2DM status, Baseline K+ value, and Baseline eGFR. Rate ratio less than 1 favors patiromer.~NBMAC=Negative binomial model adjusted for covariates; RR=Rate Ratio; T2DM=Type 2 diabetes mellitus; eGFR=Estimated glomerular filtration rate"||0.81|0.534|< 0.001
71056897|NCT03888066|141618550|SUPERIORITY||Win Ratio|1.526|||<|0.001|TWO_SIDED|95.0|1.231|1.906|||Win Ratio|||"Win ratio for composite.~Win ratio approach: Patients in the new treatment and control groups are formed into matched pairs based on their risk profiles. For each matched pair, the new treatment patient is labelled winner/loser depending on CV/hyperkalemia event first. The win ratio is the total number of winners divided by the total numbers of losers."||1.906|1.231|<0.001
71056898|NCT03888066|141618550|SUPERIORITY||Win Ratio|0.914|||=|0.744|TWO_SIDED|95.0|0.526|1.578|||Win Ratio|||"Win ratio CV death and hospitalization.~Win ratio approach: Patients in the new treatment and control groups are formed into matched pairs based on their risk profiles. For each matched pair, the new treatment patient is labelled winner/loser depending on CV/hyperkalemia event first. The win ratio is the total number of winners divided by the total numbers of losers. Unmatched win ratio is presented for this endpoint. Win ratio above 1 favors patiromer."||1.578|0.526|= 0.744
71056899|NCT03888066|141618551|SUPERIORITY||Win Ratio|1.248|||=|0.048|TWO_SIDED|95.0|1.003|1.564|||Win Ratio|||"Win ratio for composite.~Win ratio approach: Patients in the new treatment and control groups are formed into matched pairs based on their risk profiles. For each matched pair, the new treatment patient is labelled winner/loser depending on CV/hyperkalemia event first. The win ratio is the total number of winners divided by the total numbers of losers. Unmatched win ratio is presented for this endpoint. Win ratio above 1 favors patiromer."||1.564|1.003|= 0.048
71107971|NCT02949011|141721539|SUPERIORITY|||||||0.7624||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.7624
71107972|NCT02949011|141721539|SUPERIORITY|||||||0.6156||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.6156
71023416|NCT01271933|141554198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.8|STANDARD_ERROR_OF_MEAN|5.49||0.2159|TWO_SIDED|95.0|-4.1|17.7||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Sleep adequacy||17.7|-4.1|0.2159
71023417|NCT01271933|141554198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.2|STANDARD_ERROR_OF_MEAN|4.1||0.2041|TWO_SIDED|95.0|-13.4|2.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Somnolence||2.9|-13.4|0.2041
71023418|NCT01271933|141554198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.8|STANDARD_ERROR_OF_MEAN|3.81||0.1319|TWO_SIDED|95.0|-13.4|1.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Sleep Problems Index I||1.8|-13.4|0.1319
71023419|NCT01271933|141554198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.7|STANDARD_ERROR_OF_MEAN|3.89||0.1473|TWO_SIDED|95.0|-13.4|2.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Sleep Problems Index II||2.0|-13.4|0.1473
71023420|NCT01271933|141554199|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3596|TWO_SIDED|95.0|-0.2|0.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||0.6|-0.2|0.3596
71023421|NCT01271933|141554201|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.4985|TWO_SIDED|95.0|0.66|2.36||Nominal p-value for two-sided test.|two-sided test|||"Odds ratio is the probability of the event occurring in Pregabalin 330 - 495 mg/day relative to the event occurring in Placebo for Pregabalin.~Odds ratio \> 1 is in favor of Pregabalin 330 - 495 mg/day."||2.36|0.66|0.4985
71023422|NCT01271933|141554203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|4.1||0.74|TWO_SIDED|95.0|-9.5|6.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Physical Functioning||6.8|-9.5|0.7400
71023423|NCT01271933|141554203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|4.89||0.5938|TWO_SIDED|95.0|-7.1|12.3||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Role-Physical||12.3|-7.1|0.5938
71023424|NCT01271933|141554203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|4.61||0.4842|TWO_SIDED|95.0|-5.9|12.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Pain Index||12.4|-5.9|0.4842
71023425|NCT01271933|141554203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|3.45||0.0827|TWO_SIDED|95.0|-12.9|0.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model|ANCOVA|||This analysis is for the domain: SF-36 General Health Perceptions||0.8|-12.9|0.0827
71023426|NCT01271933|141554203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|4.73||0.4561|TWO_SIDED|95.0|-12.09|5.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Vitality||5.8|-12.09|0.4561
71023427|NCT01271933|141554203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|4.31||0.9645|TWO_SIDED|95.0|-8.8|8.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Social Functioning||8.4|-8.8|0.9645
71107973|NCT02949011|141721540|SUPERIORITY|||||||0.034||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.0340
71107974|NCT02949011|141721540|SUPERIORITY|||||||0.2766||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.2766
71023428|NCT01271933|141554203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|5.41||0.7636|TWO_SIDED|95.0|-9.1|12.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Role-Emotional||12.4|-9.1|0.7636
71023429|NCT01271933|141554203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|3.54||0.7067|TWO_SIDED|95.0|-5.7|8.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Mental Health Index||8.4|-5.7|0.7067
71023430|NCT01271933|141554203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.78||0.8352|TWO_SIDED|95.0|-3.9|3.2||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Physical Component Score||3.2|-3.9|0.8352
71023431|NCT01271933|141554203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|2.22||0.9347|TWO_SIDED|95.0|-4.2|4.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Mental Component Score||4.6|-4.2|0.9347
70934253|NCT03365622|141369340|SUPERIORITY||Mean Difference (Final Values)|6.306|STANDARD_ERROR_OF_MEAN|7.379||0.3938|TWO_SIDED|95.0|-8.242|20.854|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the total opioid dose administered intraoperatively and postoperatively, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||20.854|-8.242|0.3938
71023432|NCT01271933|141554205|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.69||0.1901|TWO_SIDED|95.0|-0.5|2.3||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||HADS-A Anxiety scale||2.3|-0.5|0.1901
71023433|NCT01271933|141554205|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.65||0.6914|TWO_SIDED|95.0|-1.6|1.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||HADS-D Depression scale||1.0|-1.6|0.6914
71023434|NCT01271933|141554207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.41||0.3721|TWO_SIDED|95.0|-0.5|1.2||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 1: Physical activities||1.2|-0.5|0.3721
71023435|NCT01271933|141554207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.64||0.8084|TWO_SIDED|95.0|-1.1|1.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 2: Feel good||1.4|-1.1|0.8084
71023436|NCT01271933|141554207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.35||0.6312|TWO_SIDED|95.0|-0.9|0.5||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 3: Work missed||0.5|-0.9|0.6312
71023437|NCT01271933|141554207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.57||0.8824|TWO_SIDED|95.0|-1.0|1.2||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 4: Do job||1.2|-1.0|0.8824
71023438|NCT01271933|141554207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.49||0.2742|TWO_SIDED|95.0|-1.5|0.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 5: Pain||0.4|-1.5|0.2742
71023439|NCT01271933|141554207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.46||0.852|TWO_SIDED|95.0|-0.8|1.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 6: Fatigue||1.0|-0.8|0.8520
71023440|NCT01271933|141554207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.55||0.5264|TWO_SIDED|95.0|-1.4|0.7||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 7: Rested||0.7|-1.4|0.5264
71023441|NCT01271933|141554207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.55||0.6601|TWO_SIDED|95.0|-1.3|0.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 8: Stiffness||0.9|-1.3|0.6601
71023442|NCT01271933|141554207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.56||0.8937|TWO_SIDED|95.0|-1.2|1.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 9: Anxiety||1.0|-1.2|0.8937
71056900|NCT05013008|141618557|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.001||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Matrilysin (P09237) was analyzed.||||= 0.001
71056901|NCT05013008|141618557|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.002||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of von Willebrand factor (P04275) was analyzed.||||= 0.002
70941672|NCT04748445|141383934|OTHER||Slope|1.615|STANDARD_ERROR_OF_MEAN|1.118||0.151|TWO_SIDED|90.0|-2.371|3.467|||Mixed Models Analysis|||MM\_MFCC std 08 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-2. For lower limit it was 10\^-3).||3.467|-2.371|0.1510
71023443|NCT01271933|141554207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.47||0.9151|TWO_SIDED|95.0|-1.0|0.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 10: Depression||0.9|-1.0|0.9151
71023444|NCT01271933|141554207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|3.91||0.9045|TWO_SIDED|95.0|-8.2|7.3||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the total score||7.3|-8.2|0.9045
71023445|NCT01271933|141554209|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.31||0.4606|TWO_SIDED|95.0|-0.4|0.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: General Fatigue||0.9|-0.4|0.4606
71023446|NCT01271933|141554209|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.37||0.4703|TWO_SIDED|95.0|-1.0|0.5||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Physical Fatigue||0.5|-1.0|0.4703
71023447|NCT01271933|141554209|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.36||0.4009|TWO_SIDED|95.0|-0.4|1.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Reduced activity||1.0|-0.4|0.4009
71023448|NCT01271933|141554209|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.35||0.0695|TWO_SIDED|95.0|-0.1|1.3||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Reduced motivation||1.3|-0.1|0.0695
71023449|NCT01271933|141554209|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.27||0.5869|TWO_SIDED|95.0|-0.7|0.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Mental fatigue||0.4|-0.7|0.5869
71023450|NCT01271933|141554211|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.29||||0.0296|TWO_SIDED|95.0|1.09|4.81||Nominal p-value for two-sided test.|two-sided test|||This analysis is for the domain: Benefit from treatment||4.81|1.09|0.0296
71023451|NCT01271933|141554211|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.29||||0.4691|TWO_SIDED|95.0|0.64|2.61||Nominal p-value for two-sided test|two-sided test|||This analysis is for the domain: Satisfaction from treatment||2.61|0.64|0.4691
71023452|NCT01271933|141554211|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.98||||0.9577|TWO_SIDED|95.0|0.48|2.01||Nominal p-value for two-sided test|two-sided test|||This analysis is for the domain: Willingness to continue treatment||2.01|0.48|0.9577
71056902|NCT05013008|141618557|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.044||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of CCN family member 4 (O95388) was analyzed.||||= 0.044
71056903|NCT05013008|141618557|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.044||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of TGF beta-1 proprotein (P01137) was analyzed.||||= 0.044
71056904|NCT05013008|141618557|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.127||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of TGF beta receptor type 3 (Q03167) was analyzed.||||= 0.127
71107975|NCT02949011|141721541|SUPERIORITY|||||||0.0072||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.0072
71023453|NCT01271933|141554213|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.3|STANDARD_ERROR_OF_MEAN|9.85||0.0562|TWO_SIDED|95.0|-0.5|39.2||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Percent Work Time Missed||39.2|-0.5|0.0562
71023454|NCT01271933|141554213|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|3.96||0.7892|TWO_SIDED|95.0|-7.0|9.2||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Percent Impairment While Working||9.2|-7.0|0.7892
71056905|NCT05013008|141618557|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.21||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX differences (corresponding to log-transformed ratio to baseline) of IL-15 receptor subunit alpha (Q13261) was analyzed.||||= 0.210
71107976|NCT02949011|141721541|SUPERIORITY|||||||0.733||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.7330
71023455|NCT01271933|141554213|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|1.82||0.0819|TWO_SIDED|95.0|-0.4|6.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Percent Activity Impairment||6.8|-0.4|0.0819
71023456|NCT01271933|141554213|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|1.91||0.4135|TWO_SIDED|95.0|-2.2|5.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Percent Overall Work Impairment||5.4|-2.2|0.4135
71023457|NCT01271933|141554224|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.24||0.1224|TWO_SIDED|95.0|-0.1|0.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||0.9|-0.1|0.1224
71023458|NCT01271933|141554225|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|4.06||0.768|TWO_SIDED|95.0|-9.3|6.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||6.9|-9.3|0.7680
70934254|NCT03365622|141369341|SUPERIORITY||Mean Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.283||0.7051|TWO_SIDED|95.0|-0.451|0.666|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 20-24 hours post-op average surgical pain, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||0.666|-0.451|0.7051
70941673|NCT04748445|141383934|OTHER||Slope|1.116|STANDARD_ERROR_OF_MEAN|1.104||0.3138|TWO_SIDED|90.0|-7.126|2.945|||Mixed Models Analysis|||MM\_MFCC std 09 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-2. For lower limit it was 10\^-3).||2.945|-7.126|0.3138
71023459|NCT01271933|141554226|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|1.29||0.136|TWO_SIDED|95.0|-4.5|0.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||0.6|-4.5|0.1360
71023460|NCT01271933|141554227|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6489.5|STANDARD_ERROR_OF_MEAN|12579.5||0.6077|TWO_SIDED|95.0|-18648.6|31627.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Total daytime activity||31627.6|-18648.6|0.6077
71023461|NCT01271933|141554228|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|1.38||0.6647|TWO_SIDED|95.0|-2.2|3.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||3.4|-2.2|0.6647
71023462|NCT00591253|141554263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.0||||0.001|TWO_SIDED|95.0|-7.97|-2.04||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-2.04|-7.97|0.001
71023463|NCT00591253|141554263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.78|||<|0.001|TWO_SIDED|95.0|-10.69|-4.86||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-4.86|-10.69|<0.001
71023464|NCT00591253|141554264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.48|||<|0.001|TWO_SIDED|95.0|-10.18|-2.78||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-2.78|-10.18|<0.001
71023465|NCT00591253|141554264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.54|||<|0.001|TWO_SIDED|95.0|-10.27|-2.81||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-2.81|-10.27|<0.001
71023466|NCT00591253|141554265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.44||||0.001|TWO_SIDED|95.0|-5.47|-1.4||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.40|-5.47|0.001
71023467|NCT00591253|141554265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.77|||<|0.001|TWO_SIDED|95.0|-7.78|-3.77||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.77|-7.78|<0.001
71023468|NCT00591253|141554266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.12||||0.004|TWO_SIDED|95.0|-5.22|-1.02||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.02|-5.22|0.004
71023469|NCT00591253|141554266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.96||||0.006|TWO_SIDED|95.0|-5.08|-0.84||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.84|-5.08|0.006
71107977|NCT02949011|141721542|SUPERIORITY||Median Difference|-48.0|||<|0.0001|TWO_SIDED|95.0|-48.0|-48.0||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region||||-48.0|-48.0|<0.0001
70851708|NCT01818752|141191316|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.211||||0.8934|TWO_SIDED|95.0|0.896|1.637||Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.|Log Rank|Log-rank p-value (1-sided) stratified by ISS stage, choice of route of bortezomib administration, region and age.|The hazard ratio (Carfilzomib/Bortezomib) was estimated using a Cox proportional hazards model stratified by ISS stage, choice of route of bortezomib administration, region and age.|||1.637|0.896|0.8934
71023470|NCT00591253|141554267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.09||||0.001|TWO_SIDED|95.0|-8.14|-2.04||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.04|-8.14|0.001
71023471|NCT00591253|141554267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.97|||<|0.001|TWO_SIDED|95.0|-10.96|-4.97||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.97|-10.96|<0.001
71023472|NCT00591253|141554268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.74|||<|0.001|TWO_SIDED|95.0|-5.86|-1.61||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.61|-5.86|<0.001
71023473|NCT00591253|141554268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|||<|0.001|TWO_SIDED|95.0|-7.99|-3.81||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.81|-7.99|<0.001
71023474|NCT00591253|141554269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.91||||0.008|TWO_SIDED|95.0|-8.54|-1.27||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.27|-8.54|0.008
71023475|NCT00591253|141554269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.27|||<|0.001|TWO_SIDED|95.0|-10.85|-3.69||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.69|-10.85|<0.001
71023476|NCT00591253|141554270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.05||||0.024|TWO_SIDED|95.0|-5.69|-0.4||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.40|-5.69|0.024
71023477|NCT00591253|141554270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.79|||<|0.001|TWO_SIDED|95.0|-8.39|-3.19||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.19|-8.39|<0.001
71023478|NCT00591253|141554271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3||||0.001|TWO_SIDED|95.0|-8.52|-2.08||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.08|-8.52|0.001
71023479|NCT00591253|141554271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.71|||<|0.001|TWO_SIDED|95.0|-10.88|-4.55||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.55|-10.88|<0.001
70941674|NCT04748445|141383934|OTHER||Slope|-0.002168|STANDARD_ERROR_OF_MEAN|9.632||0.8223|TWO_SIDED|90.0|-0.01813|0.01379|||Mixed Models Analysis|||MM\_MFCC std 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.01379|-0.01813|0.8223
71023480|NCT00591253|141554272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.81||||0.001|TWO_SIDED|95.0|-6.08|-1.54||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.54|-6.08|0.001
71023481|NCT00591253|141554272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.65|||<|0.001|TWO_SIDED|95.0|-7.88|-3.41||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.41|-7.88|<0.001
71023482|NCT00591253|141554273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.86||||0.014|TWO_SIDED|95.0|-8.72|-1.01||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.01|-8.72|0.014
71023483|NCT00591253|141554273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.71|||<|0.001|TWO_SIDED|95.0|-12.5|-4.92||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.92|-12.50|<0.001
71023484|NCT00591253|141554274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.04||||0.012|TWO_SIDED|95.0|-7.17|-0.91||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.91|-7.17|0.012
71023485|NCT00591253|141554274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.55|||<|0.001|TWO_SIDED|95.0|-10.63|-4.48||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.48|-10.63|<0.001
71023486|NCT00591253|141554275|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.15||||0.004|TWO_SIDED|95.0|1.27|3.65||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||3.65|1.27|0.004
71107978|NCT02949011|141721542|SUPERIORITY||Median Difference|-48.0|||<|0.0001|TWO_SIDED|95.0|-48.0|-24.0||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region||||-24.0|-48.0|<0.0001
71107979|NCT02949011|141721543|SUPERIORITY||Median Difference|-24.0||||0.0006|TWO_SIDED|95.0|-96.0|0.0||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region||||0.0|-96.0|0.0006
71023487|NCT00591253|141554275|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93||||0.016|TWO_SIDED|95.0|1.13|3.31||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||3.31|1.13|0.016
71023488|NCT00591253|141554276|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.018|TWO_SIDED|95.0|1.11|3.08||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||3.08|1.11|0.018
71023489|NCT00591253|141554276|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.89||||0.015|TWO_SIDED|95.0|1.13|3.16||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||3.16|1.13|0.015
71023490|NCT00591253|141554277|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.35||||0.004|TWO_SIDED|95.0|1.31|4.24||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||4.24|1.31|0.004
71023491|NCT00591253|141554277|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.84|||<|0.001|TWO_SIDED|95.0|1.57|5.13||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||5.13|1.57|<0.001
71023492|NCT01841359|141554282|OTHER|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.90
71023493|NCT01841359|141554283|OTHER|||||||0.08|||||||t-test, 2 sided|||||||0.08
70934255|NCT03365622|141369342|SUPERIORITY||Mean Difference (Final Values)|0.276|STANDARD_ERROR_OF_MEAN|0.317||0.3852|TWO_SIDED|95.0|-0.349|0.901|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 1-2 hours post-op average surgical pain, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||0.901|-0.349|0.3852
70941675|NCT04748445|141383934|OTHER||Slope|1.394|STANDARD_ERROR_OF_MEAN|1.081||0.1997|TWO_SIDED|90.0|-3.978|3.185|||Mixed Models Analysis|||MM\_MFCC std 11 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-2. For lower limit it was 10\^-3).||3.185|-3.978|0.1997
71023494|NCT01841359|141554284|OTHER||||||=|0.20492|||||||t-test, 2 sided|||||||= 0.20492
71023495|NCT01841359|141554285|OTHER|||||||0.2655|||||||t-test, 2 sided|||||||0.2655
71023496|NCT01841359|141554286|OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
71023497|NCT01841359|141554287|OTHER|||||||0.597|||||||t-test, 2 sided|||||||0.597
71023498|NCT01841359|141554288|OTHER|||||||0.37|||||||t-test, 2 sided|||||||0.37
71023499|NCT01841359|141554289|OTHER|||||||0.14|||||||t-test, 2 sided|||||||0.14
71107980|NCT02949011|141721543|SUPERIORITY||Median Difference|0.0||||0.237|TWO_SIDED|95.0|-48.0|24.0||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region||||24.0|-48.0|0.2370
71023500|NCT01841359|141554290|OTHER|||||||0.412|||||||t-test, 2 sided|||||||0.412
71023501|NCT01841359|141554291|OTHER|||||||0.89|||||||t-test, 2 sided|||||||0.890
71023502|NCT01841359|141554292|OTHER|||||||0.69|||||||Fisher Exact|||||||0.69
71023503|NCT01102777|141554300|SUPERIORITY_OR_OTHER|||||||0.142|TWO_SIDED||||||Regression, Linear|Adjusted for baseline value of outcome, MMRC dyspnea score, and urban versus rural residence.||||||0.142
71023504|NCT01102777|141554301|SUPERIORITY_OR_OTHER|||||||0.502|TWO_SIDED||||||Mixed Models Analysis|Based on mixed models, adjusting for group, time, group\*time interaction, MMRC score, and urban versus rural residence.||||||.502
71023505|NCT01102777|141554302|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Regression, Linear|Adjusted for baseline value and rural residence.||||||.90
71107981|NCT02949011|141721544|SUPERIORITY|||||||0.7698||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||12 hours||||0.7698
71107982|NCT02949011|141721544|SUPERIORITY|||||||0.5777||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||12 hours||||0.5777
71107983|NCT02949011|141721544|SUPERIORITY|||||||0.1112||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||24 hours||||0.1112
71023506|NCT01102777|141554303|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED||||||Regression, Linear|Adjusted for baseline value and rural residence.||||||.93
71023507|NCT01102777|141554304|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Zero inflated Poisson regression|Adjusted for age, gender, oxygen use, and arm.||||||.08
71023508|NCT01102777|141554305|SUPERIORITY_OR_OTHER|||||||0.731|TWO_SIDED||||||Mixed Models Analysis|Based on mixed models, adjusting for group, time, group\*time interaction, MMRC score, and urban versus rural residence.||||||0.731
71023509|NCT01102777|141554306|SUPERIORITY_OR_OTHER|||||||0.52|||||||Mixed Models Analysis|Based on mixed models, adjusting for time, MMRC score, and urban versus rural residence.||||||.52
71023510|NCT01102777|141554307|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|||||||||The determination of arm occurred after recruitment, and Study Reach is a recruitment value.||||
71023511|NCT01102777|141554308|SUPERIORITY_OR_OTHER|||||||0.11|||||||Regression, Linear|Adjusting for time, MMRC score, and urban versus rural residence.||||||.11
71023512|NCT01102777|141554309|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mixed Models Analysis|Based on mixed models, adjusting for time, MMRC score, and urban versus rural residence.||||||.01
71023513|NCT00947765|141554313|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71023514|NCT00947765|141554314|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71023515|NCT00947765|141554315|SUPERIORITY_OR_OTHER|||||||0.0022||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0022
71023516|NCT00947765|141554316|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.003
71023517|NCT00947765|141554317|SUPERIORITY_OR_OTHER|||||||0.0127||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0127
71023518|NCT00947765|141554318|SUPERIORITY_OR_OTHER|||||||0.0184||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0184
71023519|NCT00947765|141554319|SUPERIORITY_OR_OTHER|||||||0.0058||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0058
71023520|NCT00947765|141554320|SUPERIORITY_OR_OTHER|||||||0.0064||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0064
71023521|NCT01965652|141554322|SUPERIORITY_OR_OTHER||LS Mean Difference|1.28|STANDARD_ERROR_OF_MEAN|0.226|<|0.0001|TWO_SIDED|95.0|0.83|1.72||The significance level was set at 0.05 (2-sided). The analysis of efficacy endpoints was not adjusted for multiplicity; hence, the p-values are purely nominal. A mixed-effects model repeated measures (MMRM) method was used for the comparisons.|Mixed-effects model repeated measures|The MMRM method included the opioid dose strata as a covariate and treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||1.72|0.83|<0.0001
71107984|NCT02949011|141721544|SUPERIORITY|||||||0.6483||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||24 hours||||0.6483
71107985|NCT02949011|141721544|SUPERIORITY|||||||0.0004||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||36 hours||||0.0004
71023522|NCT01965652|141554322|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|0.53|1.47|||Mixed-effects model repeated measures|The MMRM method included the opioid dose strata as a covariate and treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||1.47|0.53|<0.0001
71023523|NCT01965652|141554322|SUPERIORITY_OR_OTHER||LS Mean Difference|1.01|STANDARD_ERROR_OF_MEAN|0.249|<|0.0001|TWO_SIDED|95.0|0.52|1.5|||Mixed-effects model repeated measures|The MMRM method included the opioid dose strata as a covariate and treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||1.50|0.52|<0.0001
71023524|NCT01965652|141554322|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.259||0.0001|TWO_SIDED|95.0|0.49|1.51|||Mixed-effects model repeated measures|The MMRM method included the opioid dose strata as a covariate and treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||1.51|0.49|0.0001
71023525|NCT01965652|141554324|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.44|-0.25|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.25|-0.44|<0.0001
71023526|NCT01965652|141554324|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001|TWO_SIDED|95.0|-0.36|-0.14|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.14|-0.36|<0.0001
71023527|NCT01965652|141554324|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|-0.4|-0.18|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.18|-0.40|<0.0001
71023528|NCT01965652|141554324|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001|TWO_SIDED|95.0|-0.47|-0.24|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.24|-0.47|<0.0001
71023529|NCT01965652|141554324|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|95.0|-0.35|-0.12|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.12|-0.35|<0.0001
71023530|NCT01965652|141554325|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.054||0.0002|TWO_SIDED|95.0|-0.31|-0.1|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.10|-0.31|0.0002
71023531|NCT01965652|141554325|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.06||0.0173|TWO_SIDED|95.0|-0.26|-0.03|||Mixed-effects model repeated meaures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.03|-0.26|0.0173
71023532|NCT01965652|141554325|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.061||0.0035|TWO_SIDED|95.0|-0.3|-0.06|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.06|-0.30|0.0035
71023533|NCT01965652|141554325|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001|TWO_SIDED|95.0|-0.4|-0.16|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.16|-0.40|<0.0001
71023534|NCT01965652|141554325|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.064||0.0336|TWO_SIDED|95.0|-0.26|-0.01|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.01|-0.26|0.0336
71023535|NCT01965652|141554326|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001|TWO_SIDED|95.0|-0.37|-0.14|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.14|-0.37|<0.0001
71023536|NCT01965652|141554326|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.063||0.0114|TWO_SIDED|95.0|-0.28|-0.04|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.04|-0.28|0.0114
71023537|NCT01965652|141554326|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.065||0.0003|TWO_SIDED|95.0|-0.36|-0.11|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.11|-0.36|0.0003
71023538|NCT01965652|141554326|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.064|<|0.0001|TWO_SIDED|95.0|-0.38|-0.13|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.13|-0.38|<0.0001
71023539|NCT01965652|141554326|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.066||0.0119|TWO_SIDED|95.0|-0.29|-0.04|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.04|-0.29|0.0119
71023540|NCT01965652|141554327|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001|TWO_SIDED|95.0|-0.64|-0.39|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.39|-0.64|<0.0001
70934256|NCT03365622|141369343|SUPERIORITY||Mean Difference (Final Values)|0.534|STANDARD_ERROR_OF_MEAN|2.816||0.8498|TWO_SIDED|95.0|-5.02|6.088|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 1-2 hours post-op inspiratory capacity percentage, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||6.088|-5.02|0.8498
71023541|NCT01965652|141554327|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.51|-0.26|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.26|-0.51|<0.0001
71023542|NCT01965652|141554327|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001|TWO_SIDED|95.0|-0.54|-0.27|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.27|-0.54|<0.0001
71023543|NCT01965652|141554327|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.071|<|0.0001|TWO_SIDED|95.0|-0.62|-0.34|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.34|-0.62|<0.0001
71023544|NCT01965652|141554327|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.072|<|0.0001|TWO_SIDED|95.0|-0.52|-0.23|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.23|-0.52|<0.0001
71023545|NCT01965652|141554328|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001|TWO_SIDED|95.0|-0.49|-0.3|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.30|-0.49|<0.0001
71023546|NCT01965652|141554328|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.051|<|0.0001|TWO_SIDED|95.0|-0.46|-0.26|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.26|-0.46|<0.0001
70941676|NCT04748445|141383934|OTHER||Slope|0.01375|STANDARD_ERROR_OF_MEAN|6.622||0.0398|TWO_SIDED|90.0|0.00278|0.02473|||Mixed Models Analysis|||MM\_MFCC std 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.02473|0.002780|0.0398
71023547|NCT01965652|141554328|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.054|<|0.0001|TWO_SIDED|95.0|-0.43|-0.22|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.22|-0.43|<0.0001
71023548|NCT01965652|141554328|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001|TWO_SIDED|95.0|-0.5|-0.29|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.29|-0.50|<0.0001
71023549|NCT01965652|141554328|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|-0.42|-0.2|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.20|-0.42|<0.0001
70934257|NCT03365622|141369344|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|3.007||0.5839|TWO_SIDED|95.0|-7.579|4.28|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 20-24 hours post-op inspiratory capacity percentage, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||4.28|-7.579|0.5839
70934258|NCT03365622|141369345|SUPERIORITY||Mean Difference (Final Values)|0.399|STANDARD_ERROR_OF_MEAN|0.344||0.2479|TWO_SIDED|95.0|-0.28|1.078|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 1-2 hours post-op dynamic pain score, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||1.078|-0.280|0.2479
70934259|NCT03365622|141369346|SUPERIORITY||Mean Difference (Final Values)|0.484|STANDARD_ERROR_OF_MEAN|0.335||0.1502|TWO_SIDED|95.0|-0.177|1.145|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 20-24 hours post-op dynamic pain score, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||1.145|-0.177|0.1502
70934260|NCT03365622|141369347|SUPERIORITY||Mean Difference (Final Values)|0.339|STANDARD_ERROR_OF_MEAN|0.313||0.2797|TWO_SIDED|95.0|-0.278|0.955|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 20-24 hours post-op surgical pain score, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||0.955|-0.278|0.2797
70934261|NCT03365622|141369348|SUPERIORITY||Mean Difference (Final Values)|-0.333|STANDARD_ERROR_OF_MEAN|0.739||0.6527|TWO_SIDED|95.0|-1.792|1.125|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and time to first narcotic use, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||1.125|-1.792|0.6527
70934262|NCT03365622|141369349|SUPERIORITY||Odds Ratio (OR)|0.465||||0.0499|TWO_SIDED|95.0|0.217|1.0|||Regression, Logistic|Adjusted for age, sex, BMI, type of surgery and TAP block.||A logistic regression model was used to examine the association between treatment assignment and incidence of nausea, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||1.000|0.217|0.0499
71023550|NCT01965652|141554329|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|-0.5|-0.28|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.28|-0.50|<0.0001
71023551|NCT01965652|141554329|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001|TWO_SIDED|95.0|-0.44|-0.2|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Anaysis||-0.20|-0.44|<0.0001
71023552|NCT01965652|141554329|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001|TWO_SIDED|95.0|-0.4|-0.15|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.15|-0.40|<0.0001
70934263|NCT03365622|141369350|SUPERIORITY||Mean Difference (Final Values)|24.492|STANDARD_ERROR_OF_MEAN|18.165||0.179|TWO_SIDED|95.0|-11.321|60.304|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and time to discharge from PACU, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||60.304|-11.321|0.179
70934264|NCT03365622|141369351|SUPERIORITY||Mean Difference (Final Values)|0.274|STANDARD_ERROR_OF_MEAN|0.253||0.2811|TWO_SIDED|95.0|-0.226|0.773|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and time to hospital discharge, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||0.773|-0.226|0.2811
71056906|NCT05013008|141618557|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.215||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Metalloproteinase inhibitor 1 (P01033) was analyzed.||||= 0.215
71023553|NCT01965652|141554329|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001|TWO_SIDED|95.0|-0.48|-0.21|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.21|-0.48|<0.0001
71023554|NCT01965652|141554329|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001|TWO_SIDED|95.0|-0.41|-0.15|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.15|-0.41|<0.0001
71023555|NCT01965652|141554330|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.051|<|0.0001|TWO_SIDED|95.0|-0.34|-0.14|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.14|-0.34|<0.0001
71023556|NCT01965652|141554330|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001|TWO_SIDED|95.0|-0.35|-0.14|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.14|-0.35|<0.0001
71023557|NCT01965652|141554330|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001|TWO_SIDED|95.0|-0.36|-0.14|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.14|-0.36|<0.0001
71023558|NCT01965652|141554330|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|95.0|-0.43|-0.19|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.19|-0.43|<0.0001
71056907|NCT05013008|141618557|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.215||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Pappalysin-1 (Q13219) was analyzed.||||= 0.215
71056908|NCT05013008|141618557|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.745||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Proto-oncogene c-Src (P12931) was analyzed.||||= 0.745
71056909|NCT05013008|141618557|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.762||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Protein AMBP (P02760) was analyzed.||||= 0.762
71107986|NCT02949011|141721544|SUPERIORITY|||||||0.5625||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||36 hours||||0.5625
71023559|NCT01965652|141554330|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.061||0.0006|TWO_SIDED|95.0|-0.33|-0.09|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.09|-0.33|0.0006
71056910|NCT05013008|141618557|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.762||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Uromodulin (P07911) was analyzed.||||= 0.762
71056911|NCT05013008|141618557|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.762||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Aminopeptidase N (P15144) was analyzed.||||= 0.762
71107987|NCT02949011|141721544|SUPERIORITY|||||||0.0072||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||48 hours||||0.0072
71107988|NCT02949011|141721544|SUPERIORITY|||||||0.6234||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||48 hours||||0.6234
70934265|NCT01823224|141369490|SUPERIORITY_OR_OTHER|||||||0.875|TWO_SIDED||||||Repeated analysis of variance|||||||0.875
70934266|NCT01823224|141369491|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Manova|||||||> 0.05
71023560|NCT01965652|141554331|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.054|<|0.0001|TWO_SIDED|95.0|-0.5|-0.29|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.29|-0.50|<0.0001
71023561|NCT01965652|141554331|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.48|-0.24|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.24|-0.48|<0.0001
71023562|NCT01965652|141554331|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001|TWO_SIDED|95.0|-0.45|-0.21|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.21|-0.45|<0.0001
71023563|NCT01965652|141554331|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001|TWO_SIDED|95.0|-0.54|-0.3|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.30|-0.54|<0.0001
71023564|NCT01965652|141554331|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.064|<|0.0001|TWO_SIDED|95.0|-0.44|-0.19|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.19|-0.44|<0.0001
71023565|NCT01965652|141554332|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.81|-0.53|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.53|-0.81|<0.0001
71023566|NCT01965652|141554332|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|-0.73|-0.43|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.43|-0.73|<0.0001
71023567|NCT01965652|141554332|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.077|<|0.0001|TWO_SIDED|95.0|-0.66|-0.36|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.36|-0.66|<0.0001
71023568|NCT01965652|141554332|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.69|-0.38|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.38|-0.69|<0.0001
71023569|NCT01965652|141554332|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.083|<|0.0001|TWO_SIDED|95.0|-0.64|-0.32|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.32|-0.64|<0.0001
71023570|NCT01965652|141554333|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71023571|NCT01121900|141554334|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax is between 80% and 125%.|Mean ratio|39.8|||||TWO_SIDED|90.0|34.4|46.0|||||Test/reference (%)|||46.0|34.4|
71107989|NCT02949011|141721544|SUPERIORITY|||||||0.0002||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||72 hours||||0.0002
71023572|NCT01121900|141554335|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-tlast) is between 80% and 125%.|Mean ratio|80.9|||||TWO_SIDED|90.0|74.2|88.3|||||Test/reference (%)|||88.3|74.2|
70934267|NCT02310581|141369505|OTHER||LS Mean Difference|104.973|STANDARD_ERROR_OF_MEAN|39.2433||0.012|TWO_SIDED|95.0|25.13|184.81|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||184.81|25.13|0.012
70934268|NCT02310581|141369505|OTHER||LS Mean Difference|86.316|STANDARD_ERROR_OF_MEAN|37.5385||0.028|TWO_SIDED|95.0|9.94|162.69|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||162.69|9.94|0.028
71023573|NCT01121900|141554336|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-∞) is between 80% and 125%.|Mean ratio|83.5|||||TWO_SIDED|90.0|76.5|91.1|||||Test/reference (%)|||91.1|76.5|
71023574|NCT01328054|141554341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.31|STANDARD_ERROR_OF_MEAN|2.151|||TWO_SIDED|90.0|2.72|9.89|||||Confidence interval (CI), estimated value and dispersion value of is presented for pre dose|||9.89|2.72|
71023575|NCT01328054|141554341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.43|STANDARD_ERROR_OF_MEAN|2.059|||TWO_SIDED|90.0|3.0|9.87|||||CI, estimated value and dispersion value of is presented for 1 hour post dose|||9.87|3.00|
71023576|NCT01328054|141554341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.71|STANDARD_ERROR_OF_MEAN|1.734|||TWO_SIDED|90.0|4.82|10.6|||||CI, estimated value and dispersion value of is presented for 2 hour post dose|||10.60|4.82|
71023577|NCT01328054|141554341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.42|STANDARD_ERROR_OF_MEAN|2.085|||TWO_SIDED|90.0|2.94|9.89|||||CI, estimated value and dispersion value of is presented for 3 hour post dose|||9.89|2.94|
71023578|NCT01328054|141554341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|2.434|||TWO_SIDED|90.0|2.54|10.65|||||CI, estimated value and dispersion value of is presented for 4 hour post dose|||10.65|2.54|
71023579|NCT01328054|141554341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.86|STANDARD_ERROR_OF_MEAN|2.573|||TWO_SIDED|90.0|1.57|10.14|||||CI, estimated value and dispersion value of is presented for 6 hour post dose|||10.14|1.57|
71023580|NCT01328054|141554341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.91|STANDARD_ERROR_OF_MEAN|2.735|||TWO_SIDED|90.0|0.35|9.47|||||CI, estimated value and dispersion value of is presented for 8 hour post dose|||9.47|0.35|
71023581|NCT01328054|141554341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.75|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|90.0|4.08|13.42|||||CI, estimated value and dispersion value of is presented for 10 hour post dose|||13.42|4.08|
71023582|NCT01328054|141554341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.76|STANDARD_ERROR_OF_MEAN|2.759|||TWO_SIDED|90.0|1.16|10.36|||||CI, estimated value and dispersion value of is presented for 12 hour post dose|||10.36|1.16|
70934269|NCT02310581|141369505|OTHER||LS Mean Difference|64.485|STANDARD_ERROR_OF_MEAN|39.2459||0.11|TWO_SIDED|95.0|-15.36|144.33|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||144.33|-15.36|0.110
71023583|NCT01328054|141554341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75|STANDARD_ERROR_OF_MEAN|2.164|||TWO_SIDED|90.0|0.15|7.36|||||CI, estimated value and dispersion value of is presented for 24 hour post dose|||7.36|0.15|
71023584|NCT00566709|141554384|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
71023585|NCT00566709|141554385|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Chi-squared, Corrected|||||||0.07
71023586|NCT00566709|141554386|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||Chi-squared, Corrected|||||||0.56
71107990|NCT02949011|141721544|SUPERIORITY|||||||0.9547||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||72 hours||||0.9547
71107991|NCT02949011|141721544|SUPERIORITY|||||||0.0012||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||96 hours||||0.0012
71023587|NCT00566709|141554387|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||t-test, 2 sided|||||||0.79
71023588|NCT00566709|141554388|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Chi-squared, Corrected|||||||0.77
71023589|NCT00566709|141554389|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Chi-squared, Corrected|||||||0.22
70934270|NCT02310581|141369508|OTHER||LS Mean Difference|14.398|STANDARD_ERROR_OF_MEAN|4.739||0.005|TWO_SIDED|95.0|4.76|24.04|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||24.04|4.76|0.005
71023590|NCT03443869|141554390|NON_INFERIORITY|LET was concluded non-inferior to VGCV if the upper bound of the two-sided 95% CI for difference in percentage of participants with adjudicated CMV disease (LET - VGCV) was no higher than 10%|Stratum-adjusted Treatment Difference|-1.4|||||TWO_SIDED|95.0|-6.5|3.8|||||Difference = LET minus VGCV|The Observed failure (OF) approach was used to handle missing values, that is participants who had discontinued prematurely from the study for any reason were not considered failures||3.8|-6.5|
71023591|NCT03443869|141554391|OTHER||Stratum-adjusted Treatment Difference|-1.7|||||TWO_SIDED|95.0|-3.4|0.1|||||Difference = LET minus VGCV|The Observed failure (OF) approach was used to handle missing values, that is participants who had discontinued prematurely from the study for any reason were not considered failures||0.1|-3.4|
71056912|NCT05013008|141618557|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.762||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of TNFRSF1A (P19438) was analyzed.||||= 0.762
71056913|NCT05013008|141618557|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.917||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Plasminogen activator inhibitor 1 (P05121) was analyzed.||||= 0.917
71107992|NCT02949011|141721544|SUPERIORITY|||||||0.186||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||96 hours||||0.1860
70934271|NCT02310581|141369508|OTHER||LS Mean Difference|8.056|STANDARD_ERROR_OF_MEAN|4.5331||0.085|TWO_SIDED|95.0|-1.17|17.28|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||17.28|-1.17|0.085
70934272|NCT02310581|141369508|OTHER||LS Mean Difference|10.063|STANDARD_ERROR_OF_MEAN|4.7393||0.041|TWO_SIDED|95.0|0.42|19.7|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||19.70|0.42|0.041
71023592|NCT03443869|141554393|OTHER||Difference in Percentages|-0.1|||||TWO_SIDED|95.0|-4.4|4.2|||||Difference = LET minus VGCV|||4.2|-4.4|
71023593|NCT03443869|141554394|OTHER||Difference in Percentages|-3.7|||||TWO_SIDED|95.0|-7.0|-0.9|||||Difference = LET minus VGCV|||-0.9|-7.0|
71023594|NCT02826603|141554400|SUPERIORITY||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.72|2.84|||Regression, Logistic|||||2.84|1.72|<0.0001
71023595|NCT02826603|141554401|SUPERIORITY||Odds Ratio (OR)|2.1|||<|0.0001|TWO_SIDED|95.0|1.63|2.72|||Regression, Logistic|||||2.72|1.63|<0.0001
71023596|NCT02826603|141554402|SUPERIORITY||Odds Ratio (OR)|2.62|||<|0.0001|TWO_SIDED|95.0|1.89|3.62|||Regression, Logistic|||||3.62|1.89|<0.0001
71023597|NCT02826603|141554403|SUPERIORITY||Odds Ratio (OR)|3.53|||<|0.0001|TWO_SIDED|95.0|2.65|4.71|||Regression, Logistic|||||4.71|2.65|<0.0001
71023598|NCT02826603|141554404|SUPERIORITY||Odds Ratio (OR)|2.33|||<|0.0001|TWO_SIDED|95.0|1.8|3.01|||Regression, Logistic|||||3.01|1.80|<0.0001
71023599|NCT02826603|141554405|SUPERIORITY||Odds Ratio (OR)|2.57|||<|0.0001|TWO_SIDED|95.0|1.96|3.37|||Regression, Logistic|||||3.37|1.96|<0.0001
71023600|NCT02826603|141554406|SUPERIORITY||Odds Ratio (OR)|2.5|||<|0.0001|TWO_SIDED|95.0|1.89|3.31|||Regression, Logistic|||||3.31|1.89|<0.0001
71023601|NCT02826603|141554407|SUPERIORITY||Odds Ratio (OR)|2.86|||<|0.0001|TWO_SIDED|95.0|1.96|4.17|||Regression, Logistic|||||4.17|1.96|<0.0001
71023602|NCT02826603|141554408|SUPERIORITY||Odds Ratio (OR)|2.85|||<|0.0001|TWO_SIDED|95.0|2.19|3.71|||Regression, Logistic|||||3.71|2.19|<0.0001
71023603|NCT02826603|141554409|SUPERIORITY||Odds Ratio (OR)|1.84|||<|0.0001|TWO_SIDED|95.0|1.41|2.41|||Regression, Logistic|||||2.41|1.41|<0.0001
71023604|NCT03558997|141554441|SUPERIORITY||Least Square (LS) Mean Difference|4.73||||0.7185|TWO_SIDED|95.0|-21.023|30.487|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab + SCIT vs SCIT) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||30.487|-21.023|0.7185
70934273|NCT02310581|141369509|OTHER||LS Mean Difference|26.665|STANDARD_ERROR_OF_MEAN|8.1991||3|TWO_SIDED|95.0|9.98|43.35|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||43.35|9.98|0003
71023605|NCT03558997|141554442|SUPERIORITY||Least Square (LS) Mean Difference|0.3||||0.5438|TWO_SIDED|95.0|-0.661|1.254|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab + SCIT vs SCIT) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||1.254|-0.661|0.5438
71023606|NCT03558997|141554443|SUPERIORITY||Least Square (LS) Mean Difference|0.03||||0.9559|TWO_SIDED|95.0|-0.877|0.928|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab vs Placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||0.928|-0.877|0.9559
71023607|NCT03558997|141554444|SUPERIORITY||Least Square (LS) Mean Difference|7.25||||0.5416|TWO_SIDED|95.0|-16.028|30.53|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab vs Placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||30.530|-16.028|0.5416
71056914|NCT05013008|141618557|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.917||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of CCN family member 2 (P29279) was analyzed.||||= 0.917
71056915|NCT05013008|141618557|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.917||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of uPAR (Q03405) was analyzed.||||= 0.917
71056916|NCT05013008|141618557|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.917||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of C-C motif chemokine 14 (Q16627) was analyzed.||||= 0.917
70934274|NCT02310581|141369509|OTHER||LS Mean Difference|21.605|STANDARD_ERROR_OF_MEAN|7.8429||0.009|TWO_SIDED|95.0|5.65|37.56|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||37.56|5.65|0.009
71023608|NCT03558997|141554445|SUPERIORITY||Least Square (LS) Mean Difference|-0.94||||0.0414|TWO_SIDED|95.0|-1.848|-0.037|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab + SCIT vs Dupilumab) of LS mean difference using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||-0.037|-1.848|0.0414
71023609|NCT03558997|141554446|SUPERIORITY||Least Square (LS) Mean Difference|-30.45||||0.0108|TWO_SIDED|95.0|-53.874|-7.034|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab + SCIT vs Dupilumab) of LS mean difference using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||-7.034|-53.874|0.0108
70934275|NCT02310581|141369509|OTHER||LS Mean Difference|22.143|STANDARD_ERROR_OF_MEAN|8.1997||0.011|TWO_SIDED|95.0|5.46|38.83|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||38.83|5.46|0.011
70934276|NCT02310581|141369510|OTHER||LS Mean Difference|63.881|STANDARD_ERROR_OF_MEAN|18.3971||0.001|TWO_SIDED|95.0|26.45|101.31|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||101.31|26.45|0.001
70934277|NCT02310581|141369510|OTHER||LS Mean Difference|50.284|STANDARD_ERROR_OF_MEAN|17.5979||0.007|TWO_SIDED|95.0|14.48|86.09|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||86.09|14.48|0.007
71023610|NCT03558997|141554447|SUPERIORITY||Median Difference|0.665||||0.1449|TWO_SIDED|95.0|-0.77|3.21|||ANCOVA||P-value was based on treatment differences of median change using rank based ANCOVA model with baseline measurement as covariate \& treatment as fixed factors. Median difference \& its 95% CI estimated with Hodges-Lehmann method.|||3.2100|-0.770|0.1449
71023611|NCT03558997|141554448|SUPERIORITY||Median Difference|335.3||||0.1231|TWO_SIDED|95.0|-551.47|1746.55|||ANCOVA||P-value was based on treatment differences of median change using rank based ANCOVA model with baseline measurement as covariate \& treatment as fixed factors. Median difference \& its 95% CI estimated with Hodges-Lehmann method.|||1746.55|-551.47|0.1231
71056917|NCT05013008|141618557|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of C-C motif chemokine 16 (O15467) was analyzed.||||= 0.979
71023612|NCT03558997|141554449|SUPERIORITY||Median Difference|-13.325|||<|0.0001|TWO_SIDED|95.0|-23.94|-8.36|||ANCOVA||P-value was based on treatment differences of median change using rank based ANCOVA model with baseline measurement as covariate \& treatment as fixed factors. Median difference \& its 95% CI estimated with Hodges-Lehmann method.|||-8.3600|-23.9400|<0.0001
71023613|NCT03558997|141554450|SUPERIORITY||Median Difference|-134.6|||<|0.0001|TWO_SIDED|95.0|-205.51|-94.98|||ANCOVA||P-value was based on treatment differences of median change using rank based ANCOVA model with baseline measurement as covariate \& treatment as fixed factors. Median difference \& its 95% CI estimated with Hodges-Lehmann method.|||-94.98|-205.51|<0.0001
71023614|NCT03558997|141554451|SUPERIORITY||Median Difference|0.84|||<|0.0001|TWO_SIDED|95.0|0.45|1.27|||ANCOVA||P-value was based on treatment differences of median change using rank based ANCOVA model with baseline measurement as covariate \& treatment as fixed factors. Median difference \& its 95% CI estimated with Hodges-Lehmann method.|||1.2700|0.4500|<0.0001
71023615|NCT02173301|141554457|SUPERIORITY|||||||0.066|||||||Mixed Models Analysis|Restricted Maximum Likelihood (REML) - an REML-based mixed model for repeated measures (MMRM) with and with baseline PASI score as covariate||||||0.066
71023616|NCT02173301|141554457|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|Restricted Maximum Likelihood (REML) - an REML-based mixed model for repeated measures (MMRM) with and with baseline PASI score as covariate||||||0.001
71023617|NCT02173301|141554457|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Restricted Maximum Likelihood (REML) - an REML-based mixed model for repeated measures (MMRM) with and with baseline PASI score as covariate||||||<0.001
71023618|NCT02173301|141554458|SUPERIORITY|||||||0.501|||||||Regression, Logistic|||Week 12 comparison||||0.501
71023619|NCT02173301|141554458|SUPERIORITY|||||||0.34|||||||Regression, Logistic|||Week 12 comparison||||0.340
71023620|NCT02173301|141554458|SUPERIORITY|||||||0.075|||||||Regression, Logistic|||Week 12 comparison||||0.075
71023621|NCT02173301|141554459|SUPERIORITY|||||||0.229|||||||Regression, Logistic|||Week 12 comparison||||0.229
71023622|NCT02173301|141554459|SUPERIORITY|||||||0.604|||||||Regression, Logistic|||Week 12 comparison||||0.604
71023623|NCT02173301|141554459|SUPERIORITY|||||||0.573|||||||Regression, Logistic|||Week 12 comparison||||0.573
71023624|NCT01710306|141554475|SUPERIORITY|||||||0.1996|||||||Chi-squared|||||||0.1996
71023625|NCT01743677|141554496|SUPERIORITY||Least Squares Mean Difference|-1.29|||||TWO_SIDED|90.0|-3.15|0.56||||||||0.56|-3.15|
71023626|NCT01743677|141554497|SUPERIORITY||Least Squares Mean Difference|-1.42|||||TWO_SIDED|90.0|-3.28|0.43||||||||0.43|-3.28|
71023627|NCT01743677|141554498|SUPERIORITY||Least Squares Mean Difference|-2.29|||||TWO_SIDED|90.0|-4.15|-0.44||||||||-0.44|-4.15|
71023628|NCT01743677|141554499|SUPERIORITY||Least Squares Mean Difference|-1.35|||||TWO_SIDED|90.0|-3.21|0.5||||||||0.50|-3.21|
71023629|NCT01743677|141554500|SUPERIORITY||Least Squares Mean Difference|1.08|||||TWO_SIDED|90.0|-0.78|2.93||||||||2.93|-0.78|
71023630|NCT01743677|141554501|SUPERIORITY||Least Squares Mean Difference|0.86|||||TWO_SIDED|90.0|-1.0|2.71||||||||2.71|-1.00|
71023631|NCT01743677|141554502|SUPERIORITY||Least Squares Mean Difference|1.15|||||TWO_SIDED|90.0|-0.71|3.0||||||||3.00|-0.71|
71023632|NCT01743677|141554503|SUPERIORITY||Least Squares Mean Difference|2.15|||||TWO_SIDED|90.0|0.29|4.0||||||||4.00|0.29|
71023633|NCT01743677|141554504|SUPERIORITY||Least Squares Mean Difference|1.35|||||TWO_SIDED|90.0|-0.5|3.21||||||||3.21|-0.50|
71023634|NCT01743677|141554505|SUPERIORITY||Least Squares Mean Difference|11.29|||||TWO_SIDED|90.0|9.62|12.96||||||||12.96|9.62|
71023635|NCT01743677|141554506|SUPERIORITY||Least Squares Mean Difference|0.16|||||TWO_SIDED|90.0|-2.11|2.44||||||0.25 hour post-dose||2.44|-2.11|
71023636|NCT01743677|141554506|SUPERIORITY||Least Squares Mean Difference|1.78|||||TWO_SIDED|90.0|-0.49|4.06||||||0.5 hour post-dose||4.06|-0.49|
71023637|NCT01743677|141554506|SUPERIORITY||Least Squares Mean Difference|2.99|||||TWO_SIDED|90.0|0.71|5.26||||||1 hour post-dose||5.26|0.71|
71023638|NCT01743677|141554506|SUPERIORITY||Least Squares Mean Difference|1.08|||||TWO_SIDED|90.0|-1.19|3.36||||||2 hours post-dose||3.36|-1.19|
71023639|NCT01743677|141554506|SUPERIORITY||Least Squares Mean Difference|2.16|||||TWO_SIDED|90.0|-0.11|4.44||||||4 hours post-dose||4.44|-0.11|
71023640|NCT01743677|141554506|SUPERIORITY||Least Squares Mean Difference|0.05|||||TWO_SIDED|90.0|-2.22|2.33||||||8 hours post-dose||2.33|-2.22|
71023641|NCT01743677|141554506|SUPERIORITY||Least Squares Mean Difference|0.49|||||TWO_SIDED|90.0|-1.79|2.76||||||12 hours post-dose||2.76|-1.79|
71023642|NCT01743677|141554506|SUPERIORITY||Least Squares Mean Difference|2.1|||||TWO_SIDED|90.0|-0.17|4.38||||||16 hours post-dose||4.38|-0.17|
71023643|NCT01743677|141554506|SUPERIORITY||Least Squares Mean Difference|0.79|||||TWO_SIDED|90.0|-1.49|3.06||||||24 hours post-dose||3.06|-1.49|
71023644|NCT00972153|141554526|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||Descriptive statistics (means, medians, frequencies) were used to evaluate the distributions of variables. One-way analysis of variance and independent t-tests or Mann-Whitney U tests were used to compare patient and environmental characteristics between groups. Generalized estimating equations were used to evaluate the effects of group and other factors on airborne CFUs/cubic meter at the surgical site in each 10 minute interval.||||<0.001
71023645|NCT00972153|141554527|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||Descriptive statistics (means, medians, frequencies) were used to evaluate the distributions of variables. One-way analysis of variance and independent t-tests or Mann-Whitney U tests were used to compare patient and environmental characteristics between groups. Generalized estimating equations were used to evaluate the effects of group and other factors on airborne CFUs/cubic meter at the surgical site in each 10 minute interval.||||<0.001
71023646|NCT04136626|141554528|SUPERIORITY||Mean Difference (Final Values)|-2.0475||||0.0871|TWO_SIDED|95.0|-4.3977|0.3027||The p-value was not adjusted for multiple comparisons because this was the pre-specified primary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the Perspectives OCD group outcome compared to the Health and Well-Being Program group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in Y-BOCS total scores between the treatment groups at endpoint (week 12).||0.3027|-4.3977|0.0871
71107993|NCT02949011|141721544|SUPERIORITY|||||||0.0274||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||120 hours||||0.0274
71023647|NCT04136626|141554528|SUPERIORITY||Difference in the amount of change|-3.4385||||0.0036|TWO_SIDED|95.0|-5.7394|-1.1376||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the difference in the amount of symptom reduction (week 12 - week 0) between Perspectives OCD and the Health and Well-Being Program group (i.e., a group difference in the amount of change over time).|Null hypothesis: there is no significant difference in the change from baseline to end-of-treatment Y-BOCS total scores between the treatment groups.||-1.1376|-5.7394|0.0036
71023648|NCT04136626|141554529|SUPERIORITY||Mean Difference (Final Values)|-0.8743||||0.3616|TWO_SIDED|95.0|-2.7666|1.0181||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the Perspectives OCD group outcome compared to the Health and Well-Being Program group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in depression severity (QIDS-SR total scores) between the treatment groups at endpoint (week 12).||1.0181|-2.7666|0.3616
71023649|NCT04136626|141554529|SUPERIORITY||Difference in the amount of change|-1.3076||||0.1973|TWO_SIDED|95.0|-3.3014|0.6862||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the difference in the amount of symptom reduction (week 12 - week 0) between Perspectives OCD and the Health and Well-Being Program group (i.e., a group difference in the amount of change over time).|Null hypothesis: there is no significant difference in the change from baseline to end-of-treatment depression severity (QIDS-SR total scores) between the treatment groups.||0.6862|-3.3014|0.1973
71023650|NCT04136626|141554530|SUPERIORITY||Mean Difference (Final Values)|-2.7992||||0.1289|TWO_SIDED|95.0|-6.4246|0.8262||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the Perspectives OCD group outcome compared to the Health and Well-Being Program group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in functional impairment (WSAS total scores) between the treatment groups at endpoint (week 12).||0.8262|-6.4246|0.1289
71023651|NCT04136626|141554530|SUPERIORITY||Difference in the amount of change|-4.5704||||0.0137|TWO_SIDED|95.0|-8.1939|-0.9468||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the difference in the amount of symptom reduction (week 12 - week 0) between Perspectives OCD and the Health and Well-Being Program group (i.e., a group difference in the amount of change over time).|Null hypothesis: there is no significant difference in the change from baseline to end-of-treatment functional impairment (WSAS total scores) between the treatment groups.||-0.9468|-8.1939|0.0137
70934278|NCT02310581|141369510|OTHER||LS Mean Difference|56.879|STANDARD_ERROR_OF_MEAN|18.3984||0.004|TWO_SIDED|95.0|19.45|94.31|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||94.31|19.45|0.004
70934279|NCT04658784|141369526|SUPERIORITY||Odds Ratio (OR)|0.51||||0.32|TWO_SIDED|95.0|0.13|1.92||OR, 95% CI, and p-values for outcomes adjusted for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery). P-value for VAS at 6-weeks was not adjusted for multiple comparisons.|Regression, Logistic|||OR calculated from logistic regression model, evaluating mean change in baseline VAS to 6-weeks.||1.92|0.13|0.32
70934280|NCT04658784|141369527|SUPERIORITY||Odds Ratio (OR)|0.48||||1|TWO_SIDED|95.0|0.04|5.65||OR, 95% CI, and p-values for outcomes adjusted for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery). P-value for VAS at 6-weeks was not adjusted for multiple comparisons.|Regression, Logistic|||OR calculated from logistic regression model, evaluating mean change in baseline VAS to 6-weeks.||5.65|0.04|1.0
70934281|NCT04658784|141369530|SUPERIORITY||Mean Difference (Net)|2.6||||1|TWO_SIDED|95.0|-3.5|8.7||Adjust for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery).|Regression, Linear|||Differences in mean change and 95% CI generated from general linear models. Change from baseline to 6- weeks.||8.7|-3.5|1.0
70934282|NCT04658784|141369530|SUPERIORITY||Mean Difference (Net)|-1.2|||||TWO_SIDED|95.0|-5.6|3.2||Adjust for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery).|Regression, Linear|||Differences in mean change and 95% CI generated from general linear models. Change from baseline to 6-months.||3.2|-5.6|
70934283|NCT04658784|141369531|SUPERIORITY||Mean Difference (Net)|0.2||||1|TWO_SIDED|95.0|-6.6|6.9||Adjust for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery).|Regression, Linear|||Differences in mean change and 95% CI generated from general linear models. Change in baseline to 6-weeks.||6.9|-6.6|1.0
70934284|NCT04658784|141369531|SUPERIORITY|Differences in mean change and 95% CI generated from general linear models. Change in baseline to 6-months.|Mean Difference (Net)|2.8||||1|TWO_SIDED|95.0|-3.1|8.6||Adjusted for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery).|Regression, Linear|||||8.6|-3.1|1
70934285|NCT04658784|141369532|SUPERIORITY||Mean Difference (Net)|-1.6||||1|TWO_SIDED|95.0|-4.4|1.3||Adjusted for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery).|Regression, Linear|||Differences in mean change and 95% CI generated from general linear models. Change from baseline to 6 months.||1.3|-4.4|1.0
70934286|NCT02095145|141369540|OTHER|||||||0.19|||||||Wilcoxon rank-sum test|||||||0.190
70934287|NCT02095145|141369540|OTHER|||||||0.211|||||||t-test, 2 sided|||||||0.211
70934288|NCT02095145|141369543|OTHER|||||||0.948|||||||Wilcoxon rank-sum test|||Baseline to Week 13 p-value||||0.948
70934289|NCT02095145|141369543|OTHER|||||||0.711|||||||Wilcoxon rank-sum test|||Baseline to Week 26 p-value||||0.711
70934290|NCT02095145|141369543|OTHER|||||||0.038|||||||Wilcoxon rank-sum test|||Baseline to Week 39 p-value||||0.038
70934291|NCT02095145|141369543|OTHER|||||||0.445|||||||Wilcoxon rank-sum test|||Baseline to Week 52 p-value||||0.445
70934292|NCT02095145|141369544|OTHER|||||||0.743|||||||Wilcoxon rank-sum test|||Baseline to Week 13 p-value||||0.743
70934293|NCT02095145|141369544|OTHER|||||||0.305|||||||Wilcoxon rank-sum test|||Baseline to Week 26 p-value||||0.305
70934294|NCT02095145|141369544|OTHER|||||||0.111|||||||Wilcoxon rank-sum test|||Baseline to Week 39 p-value||||0.111
70934295|NCT02095145|141369544|OTHER|||||||0.395|||||||Wilcoxon rank-sum test|||Baseline to Week 52 p-value||||0.395
70934296|NCT02095145|141369545|OTHER|||||||0.743|||||||Wilcoxon rank-sum test|||Change from Baseline PSA to Week 13||||0.743
70934297|NCT02095145|141369545|OTHER|||||||0.527|||||||Wilcoxon rank-sum test|||Change from Baseline PSA to Week 26||||0.527
70934298|NCT02095145|141369545|OTHER|||||||0.879|||||||Wilcoxon rank-sum test|||Change from Baseline PSA to Week 39||||0.879
70934299|NCT02095145|141369545|OTHER|||||||0.81|||||||Wilcoxon rank-sum test|||Change from Baseline PSA to Week 52||||0.810
70934300|NCT02095145|141369546|OTHER|||||||0.556|||||||Wilcoxon rank-sum test|||Comparison of both arms at baseline||||0.556
70934301|NCT02095145|141369546|OTHER|||||||0.647|||||||Wilcoxon rank-sum test|||comparison of both arms at Week 26||||0.647
70934302|NCT02095145|141369546|OTHER|||||||0.948|||||||Wilcoxon rank-sum test|||comparison of both arms at end of study, week 52||||0.948
70934303|NCT02095145|141369547|OTHER|||||||0.58|||||||Wilcoxon rank-sum test|||||||0.580
71107994|NCT02949011|141721544|SUPERIORITY|||||||0.9635||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||120 hours||||0.9635
70934304|NCT02095145|141369548|OTHER|||||||0.344|||||||Wilcoxon rank-sum test|||Benign core p-value||||0.344
70934305|NCT02095145|141369548|OTHER|||||||0.371|||||||Wilcoxon rank-sum test|||Adjacent core p-value||||0.371
70934306|NCT02095145|141369548|OTHER|||||||0.766|||||||Wilcoxon rank-sum test|||Tumor core p-value||||0.766
70934307|NCT02095145|141369549|OTHER|||||||0.304|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Benign (Nuc)||||0.304
70934308|NCT02095145|141369549|OTHER|||||||0.23|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Adjacent (Nuc)||||0.230
70934309|NCT02095145|141369549|OTHER|||||||0.298|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Tumor (Nuc)||||0.298
70934310|NCT02095145|141369549|OTHER|||||||0.247|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Benign (Cyt)||||0.247
70934311|NCT02095145|141369549|OTHER|||||||0.093|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Adjacent (Cyt)||||0.093
70934312|NCT02095145|141369549|OTHER|||||||0.066|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Tumor (Cyt)||||0.066
70934313|NCT02095145|141369549|OTHER|||||||0.247|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Benign (Cell)||||0.247
70934314|NCT02095145|141369549|OTHER|||||||0.128|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Adjacent (Cell)||||0.128
70934315|NCT02095145|141369549|OTHER|||||||0.128|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Tumor (Cell)||||0.128
70934316|NCT02095145|141369550|OTHER|||||||0.297|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Benign p-value||||0.297
70934317|NCT02095145|141369550|OTHER|||||||0.233|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Adjacent p-value||||0.233
70934318|NCT02095145|141369550|OTHER|||||||0.371|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Tumor p-value||||0.371
70934319|NCT02095145|141369550|OTHER|||||||0.198|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Benign p-value||||0.198
70934320|NCT02095145|141369550|OTHER|||||||0.233|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Adjacent p-value||||0.233
70934321|NCT02095145|141369550|OTHER|||||||0.074|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Tumor p-value||||0.074
70934322|NCT02095145|141369550|OTHER|||||||0.234|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Benign p-value||||0.234
70934323|NCT02095145|141369550|OTHER|||||||0.233|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Adjacent p-value||||0.233
70934324|NCT02095145|141369550|OTHER|||||||0.233|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Tumor p-value||||0.233
70934325|NCT02095145|141369551|OTHER|||||||0.167|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Benign p-value||||0.167
70934326|NCT02095145|141369551|OTHER|||||||0.391|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Adjacent p-value||||0.391
70934327|NCT02095145|141369551|OTHER|||||||0.713|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Tumor p-value||||0.713
70934328|NCT02095145|141369551|OTHER|||||||0.452|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Benign p-value||||0.452
70934329|NCT02095145|141369551|OTHER|||||||0.391|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Adjacent p-value||||0.391
70934330|NCT02095145|141369551|OTHER|||||||0.713|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Tumor p-value||||0.713
70934331|NCT02095145|141369551|OTHER|||||||0.344|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Benign p-value||||0.344
70934332|NCT02095145|141369551|OTHER|||||||0.391|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Adjacent p-value||||0.391
70934333|NCT02095145|141369551|OTHER|||||||0.713|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Tumor p-value||||0.713
70934334|NCT02095145|141369552|OTHER|||||||0.865|||||||Wilcoxon rank-sum test|||Change from Baseline: Benign p-value||||0.865
70934335|NCT02095145|141369552|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline: Adjacent p-value||||1.000
70934336|NCT02095145|141369552|OTHER|||||||0.066|||||||Wilcoxon rank-sum test|||Change from Baseline: Tumor p-value||||0.066
70934337|NCT02095145|141369553|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline: Nuc Benign p-value||||1.000
70934338|NCT02095145|141369553|OTHER|||||||0.903|||||||Wilcoxon rank-sum test|||Change from Baseline: Nuc Adjacent p-value||||0.903
70934339|NCT02095145|141369553|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline: Nuc Tumor p-value||||1.000
70934340|NCT02095145|141369553|OTHER|||||||0.269|||||||Wilcoxon rank-sum test|||Change from Baseline: Cyt Benign p-value||||0.269
70934341|NCT02095145|141369553|OTHER|||||||0.066|||||||Wilcoxon rank-sum test|||Change from Baseline: Cyt Adjacent p-value||||0.066
70934342|NCT02095145|141369553|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline: Cyt Tumor p-value||||1.000
70934343|NCT02095145|141369553|OTHER|||||||0.425|||||||Wilcoxon rank-sum test|||Change from Baseline: Cell Benign p-value||||0.425
70934344|NCT02095145|141369553|OTHER|||||||0.27|||||||Wilcoxon rank-sum test|||Change from Baseline: Cell Adjacent p-value||||0.270
70934345|NCT02095145|141369553|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline: Cell Tumor p-value||||1.000
71023652|NCT04136626|141554531|SUPERIORITY||Mean Difference (Final Values)|4.3953||||0.1796|TWO_SIDED|95.0|-2.0543|10.8448||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the Perspectives OCD group outcome compared to the Health and Well-Being Program group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in quality of life (Q-LES-Q-SF percentage scores) between the treatment groups at endpoint (week 12).||10.8448|-2.0543|0.1796
71023653|NCT04136626|141554531|SUPERIORITY||Difference in the amount of change|6.7962||||0.04|TWO_SIDED|95.0|0.314|13.2785||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the difference in the amount of symptom reduction (week 12 - week 0) between Perspectives OCD and the Health and Well-Being Program group (i.e., a group difference in the amount of change over time).|Null hypothesis: there is no significant difference in the change from baseline to end-of-treatment quality of life (Q-LES-Q-SF percentage scores) between the treatment groups.||13.2785|0.3140|0.0400
71023654|NCT00409188|141554532|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.893||||0.1566|TWO_SIDED|95.0|0.763|1.044|||Regression, Cox|||||1.044|0.763|0.1566
71023655|NCT00409188|141554533|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.845||||0.0226|TWO_SIDED|95.0|0.732|0.977|||Regression, Cox|||||0.977|0.732|0.0226
71023656|NCT00409188|141554534|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.868||||0.0528|TWO_SIDED|95.0|0.752|1.002|||Regression, Cox|||||1.002|0.752|0.0528
71023657|NCT00433381|141554569|OTHER|||||||||||||||||Null hypothesis: 20% of patients progression-free at six months. Alternative hypothesis: 35%. Type I and II error rates = 0.10. Required sample size = 57.|The determination of treatment efficacy was to be made made based on the following rules: If 16 or more of the cases (16/57=28.1%) are progression free and alive at 6 months, then reject the null hypothesis that the rate is no better than 20%. If 15 or fewer of the cases (15/57=26.3%) are progression free and alive at 6 months, then reject the alternative hypothesis that the rate is at least 35%.|||
71023658|NCT00433381|141554570|OTHER|||||||||||||||||Null hypothesis: 35% discontinuation rate of bevacizumab and temozolomide. Alternative hypothesis: 5%. Type I and II error rates = 0.10. Sample size = 29.|The determination of treatment tolerability was to be made based on the following rules: If 6 or fewer of the cases (6/29=20.6%) stop treatment due to medical conditions, then reject the null hypothesis that the discontinuation rate is at least 35% and conclude tolerability. If 7 or more of the cases (7/29=24.1%) stop treatment due to medical conditions, then reject the alternative hypothesis that the discontinuation rate no more than 15%.|||
71023659|NCT00433381|141554571|OTHER|Receiver Operating Characteristic (ROC) analysis|Area Under the Curve (AUC)|0.5|||||TWO_SIDED|95.0|0.09|0.91||||||Accuracy estimate, as measured by the Area under the Curve (AUC), for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cho at 2 weeks||0.91|0.09|
71023660|NCT00433381|141554571|OTHER|ROC analysis|Area Under the Curve (AUC)|0.54|||||TWO_SIDED|95.0|0.14|0.95||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor Cho/Cr at 2 weeks||0.95|0.14|
70934346|NCT02095145|141369554|OTHER|||||||0.625|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Benign p-value||||0.625
70934347|NCT02095145|141369554|OTHER|||||||0.128|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Adjacent p-value||||0.128
70934348|NCT02095145|141369554|OTHER|||||||0.045|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Tumor p-value||||0.045
70934349|NCT02095145|141369554|OTHER|||||||0.105|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Benign p-value||||0.105
70934350|NCT02095145|141369554|OTHER|||||||0.066|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Adjacent p-value||||0.066
70934351|NCT02095145|141369554|OTHER|||||||0.005|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Tumor p-value||||0.005
70934352|NCT02095145|141369554|OTHER|||||||0.129|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Benign p-value||||0.129
70934353|NCT02095145|141369554|OTHER|||||||0.066|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Adjacent p-value||||0.066
70934354|NCT02095145|141369554|OTHER|||||||0.013|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Tumor p-value||||0.013
70934355|NCT02095145|141369555|OTHER|||||||0.143|||||||Wilcoxon rank-sum test|||Change from Baseline: Benign p-value||||0.143
70934356|NCT02095145|141369555|OTHER|||||||0.037|||||||Wilcoxon rank-sum test|||Change from Baseline: Adjacent p-value||||0.037
70934357|NCT02095145|141369555|OTHER|||||||0.111|||||||Wilcoxon rank-sum test|||Change from Baseline: Tumor p-value||||0.111
70934358|NCT02095145|141369556|OTHER|||||||0.068|||||||Wilcoxon rank-sum test|||Change from Baseline Week 13||||0.068
70934359|NCT02095145|141369556|OTHER|||||||0.004|||||||Wilcoxon rank-sum test|||Change from Baseline Week 26||||0.004
70934360|NCT02095145|141369556|OTHER|||||||0.002|||||||Wilcoxon rank-sum test|||Change from Baseline Week 39||||0.002
71023661|NCT00433381|141554571|OTHER|ROC analysis|Area Under the Curve (AUC)|0.46|||||TWO_SIDED|95.0|0.0|0.99||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cr at 2 weeks||0.99|0|
71023662|NCT00433381|141554571|OTHER||Area Under the Curve (AUC)|0.85|||||TWO_SIDED|95.0|0.53|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cho at 8 weeks||1|0.53|
71023663|NCT00433381|141554571|OTHER||Area Under the Curve (AUC)|0.83|||||TWO_SIDED|95.0|0.47|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor Cho/Cr at 8 weeks||1|0.47|
71023664|NCT00433381|141554571|OTHER||Area Under the Curve (AUC)|0.6|||||TWO_SIDED|95.0|0.11|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cr at 8 weeks||1|0.11|
71023665|NCT00433381|141554571|OTHER||Area Under the Curve (AUC)|0.75|||||TWO_SIDED|95.0|0.21|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cho at 16 weeks||1|0.21|
71023666|NCT00433381|141554571|OTHER|ROC analysis|Area Under the Curve (AUC)|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor Cho/Cr at 16 weeks||1|1|
71023667|NCT00433381|141554571|OTHER|ROC analysis|Area Under the Curve (AUC)|0.46|||||TWO_SIDED|95.0|0.0|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cr at 16 weeks||1|0|
71023668|NCT00433381|141554571|OTHER|ROC analysis|Area Under the Curve (AUC)|0.39|||||TWO_SIDED|95.0|0.0|0.88||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cho at 2 weeks||0.88|0|
71023669|NCT00433381|141554571|OTHER|ROC analysis|Area Under the Curve (AUC)|0.52|||||TWO_SIDED|95.0|0.13|0.91||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery Cho/Cr at 2 weeks||0.91|0.13|
71023670|NCT00433381|141554571|OTHER|ROC analysis|Area Under the Curve (AUC)|0.54|||||TWO_SIDED|95.0|0.06|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cr at 2 weeks||1|0.06|
70934361|NCT02095145|141369556|OTHER||||||<|0.001|||||||Wilcoxon rank-sum test|||Change from Baseline Week 52||||<0.001
70934362|NCT02095145|141369557|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline Week 13||||1.000
70934363|NCT02095145|141369557|OTHER|||||||0.18|||||||Wilcoxon rank-sum test|||Change from Baseline Week 26||||0.180
70934364|NCT02095145|141369557|OTHER|||||||0.62|||||||Wilcoxon rank-sum test|||Change from Baseline Week 39||||0.620
70934365|NCT02095145|141369557|OTHER|||||||0.536|||||||Wilcoxon rank-sum test|||Change from Baseline Week 52||||0.536
70934366|NCT02095145|141369559|OTHER|||||||0.231|||||||Wilcoxon rank-sum test|||Change in Tumor Volume from baseline to end of study per arm||||0.231
70934367|NCT01034306|141369593|SUPERIORITY|||||||0.0352||||||normal approximation to the binomial test|t-test, 2 sided|||||||0.0352
70934368|NCT01034306|141369594|SUPERIORITY|||||||0.2472|||||||t-test, 2 sided|||||||.2472
71056918|NCT05013008|141618557|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Collagen alpha-1(I) chain (P02452) was analyzed.||||= 0.979
71056919|NCT05013008|141618557|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Decorin (P07585) was analyzed.||||= 0.979
71056920|NCT05013008|141618557|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX differences (corresponding to log-transformed ratio to baseline) of C-C motif chemokine 2 (P13500) was analyzed.||||= 0.979
70851709|NCT01818752|141191317|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.412||||0.0218|TWO_SIDED|95.0|1.01|1.973||Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.|Stratified Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Chi-square test stratified by ISS stage, choice of route of bortezomib administration, region and age.|Odds ratio (Carfilzomib/Bortezomib) was estimated using the Mantel-Haenszel method stratified by ISS stage, choice of route of bortezomib administration, region and age.|||1.973|1.010|0.0218
70934369|NCT01034306|141369595|SUPERIORITY|||||||0.1972|||||||t-test, 2 sided|||||||0.1972
70934370|NCT01619059|141369609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.087|<|0.0001|TWO_SIDED|95.0|-0.52|-0.18||Tested at alpha=0.05|Mixed Models Analysis|||||-0.18|-0.52|<0.0001
70934371|NCT01619059|141369610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|STANDARD_ERROR_OF_MEAN|4.576||0.2014|TWO_SIDED|95.0|-14.9|3.1||Secondary endpoints were tested at alpha=0.05, applying the hierarchical order for the sequential testing procedure|Mixed Models Analysis|||||3.1|-14.9|0.2014
70934372|NCT01619059|141369611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|3.713|||TWO_SIDED|95.0|-11.0|3.6||||||||3.6|-11.0|
70934373|NCT01619059|141369612|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.2|STANDARD_ERROR_OF_MEAN|4.504|||TWO_SIDED|95.0|3.4|21.0||||||||21.0|3.4|
70934374|NCT03418545|141369613|SUPERIORITY||Percentage difference|67.5|||<|0.0001|TWO_SIDED|95.0|52.9|82.0||The p-value and 95% CI are computed by pooling 5 imputed datasets using PROC MIANALYZE in SAS with normal approximation. The p-value and 95% CI for each imputed data set is based on the Fisher's exact test and the Wald test, respectively.|Fisher Exact|||||82.0|52.9|<0.0001
70934375|NCT03418545|141369614|SUPERIORITY||Percentage difference|73.5|||||TWO_SIDED|95.0|60.2|86.8|||||The 95% CI is based on the Wald test.|||86.8|60.2|
70934376|NCT03418545|141369616|SUPERIORITY||||||<|0.0001||||||A 2-sided paired t-test at the 5% level was performed to demonstrate that the mean overall satisfaction score at Month 3 was statistically greater than that at Baseline for the treatment group.|t-test, 2 sided|||||||<0.0001
70934377|NCT01989793|141369640|EQUIVALENCE|Equivalence margin=0||||||0.97|||||||t-test, 2 sided|||Two-sample T-test of between-arm difference of change in isokinetic knee strength from baseline to week 8||||0.97
70934378|NCT01989793|141369641|EQUIVALENCE|Equivalence margin=0||||||0.48|||||||t-test, 2 sided|||Two-sample T-test of between-arm difference of change in isokinetic knee strength from baseline to week 16||||0.48
70934379|NCT01989793|141369642|EQUIVALENCE|Equivalence margin = 0||||||0.59|||||||t-test, 2 sided|||Two-sample T-test of between-arm difference of change in isokinetic knee strength from baseline to week 24||||0.59
71023671|NCT00433381|141554571|OTHER|ROC analysis|Area Under the Curve (AUC)|0.47|||||TWO_SIDED|95.0|0.02|0.92||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cho at 8 weeks||0.92|0.02|
71023672|NCT00433381|141554571|OTHER|ROC analysis|Area Under the Curve (AUC)|0.41|||||TWO_SIDED|95.0|0.01|0.8||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery Cho/Cr at 8 weeks||0.80|0.01|
71023673|NCT00433381|141554571|OTHER|ROC analysis|Area Under the Curve (AUC)|0.63|||||TWO_SIDED|95.0|0.22|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cr at 8 weeks||1|0.22|
71023674|NCT00433381|141554571|OTHER|ROC analysis|Area Under the Curve (AUC)|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cho at 16 weeks||1|1|
71023675|NCT00433381|141554571|OTHER|ROC analysis|Area Under the Curve (AUC)|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery Cho/Cr at 16 weeks||1|1|
71023676|NCT00433381|141554571|OTHER|ROC analysis|Area Under the Curve (AUC)|0.93|||||TWO_SIDED|95.0|0.73|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cr at 16 weeks||1|0.73|
71023677|NCT00433381|141554572|OTHER|ROC analysis|Area Under the Curve (AUC)|0.42|||||TWO_SIDED|95.0|0.0|0.92||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cho at 2 weeks||0.92|0|
71023678|NCT00433381|141554572|OTHER|ROC analysis|Area Under the Curve (AUC)|0.42|||||TWO_SIDED|95.0|0.0|0.88||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor Cho/Cr at 2 weeks||0.88|0|
71023679|NCT00433381|141554572|OTHER|ROC analysis|Accuracy: Area Under the ROC|0.67|||||TWO_SIDED|95.0|0.25|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cr at 2 weeks||1|0.25|
71023680|NCT00433381|141554572|OTHER|ROC analysis|Area Under the Curve (AUC)|0.8|||||TWO_SIDED|95.0|0.47|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cho at 8 weeks||1|0.47|
71023681|NCT00433381|141554572|OTHER|ROC analysis|Area Under the Curve (AUC)|0.78|||||TWO_SIDED|95.0|0.44|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor Cho/Cr at 8 weeks||1|0.44|
70934380|NCT01989793|141369643|EQUIVALENCE|Equivalence margin=0||||||0.212|||||||t-test, 2 sided|assuming unequal variance between arms||Two-sample T-test of between-arm difference in fatiguability at week 8||||0.212
70934381|NCT01989793|141369644|EQUIVALENCE|Equivalence margin=0||||||0.271|||||||t-test, 2 sided|assuming unequal variance between arms||Two-sample T-test of between-arm difference in fatiguability at week 16||||0.271
71023682|NCT00433381|141554572|OTHER|ROC analysis|Area Under the Curve (AUC)|0.6|||||TWO_SIDED|95.0|0.17|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cr at 8 weeks||1|0.17|
71023683|NCT00433381|141554572|OTHER|ROC analysis|Area Under the Curve (AUC)|0.8|||||TWO_SIDED|95.0|0.45|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cho at 16 weeks||1|0.45|
71023684|NCT00433381|141554572|OTHER|ROC analysis|Area Under the Curve (AUC)|0.73|||||TWO_SIDED|95.0|0.19|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor Cho/Cr at 16 weeks||1|0.19|
71023685|NCT00433381|141554572|OTHER|ROC analysis|Area Under the Curve (AUC)|0.57|||||TWO_SIDED|95.0|0.03|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cr at 16 weeks||1|0.03|
71023686|NCT00433381|141554572|OTHER|ROC analysis|Area Under the Curve (AUC)|0.6|||||TWO_SIDED|95.0|0.2|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cho at 2 weeks||1|0.20|
71023687|NCT00433381|141554572|OTHER|ROC analysis|Area Under the Curve (AUC)|0.72|||||TWO_SIDED|95.0|0.36|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery Cho/Cr at 2 weeks||1|0.36|
71023688|NCT00433381|141554572|OTHER|ROC analysis|Area Under the Curve (AUC)|0.5|||||TWO_SIDED|95.0|0.06|0.94||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cr at 2 weeks||0.94|0.06|
71023689|NCT00433381|141554572|OTHER|ROC analysis|Area Under the Curve (AUC)|0.58|||||TWO_SIDED|95.0|0.22|0.95||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cho at 8 weeks||0.95|0.22|
71056921|NCT05013008|141618557|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Matrix metalloproteinase-9 (P14780) was analyzed.||||= 0.979
70934382|NCT01989793|141369645|EQUIVALENCE|Equivalence margin=0||||||0.203|||||||t-test, 2 sided|assuming unequal variance between arms||Two-sample T-test of between-arm difference in fatiguability at week 24||||0.203
71023690|NCT00433381|141554572|OTHER|ROC analysis|Area Under the Curve (AUC)|0.5|||||TWO_SIDED|95.0|0.13|0.87||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery Cho/Cr at 8 weeks||0.87|0.13|
71023691|NCT00433381|141554572|OTHER|ROC analysis|Area Under the Curve (AUC)|0.78|||||TWO_SIDED|95.0|0.47|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cr at 8 weeks||1|0.47|
71023692|NCT00433381|141554572|OTHER|ROC analysis|Area Under the Curve (AUC)|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cho at 16 weeks||1|1|
71023693|NCT00433381|141554572|OTHER|ROC analysis|Area Under the Curve (AUC)|0.89|||||TWO_SIDED|95.0|0.63|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery Cho/Cr at 16 weeks||1|0.63|
70934383|NCT01989793|141369646|EQUIVALENCE|Equivalence margin = 0||||||0.82|||||||Fisher Exact|||Fisher's exact test of percentage of participants with improvement in frailty score from baseline between treatment and placebo arms||||0.82
71023694|NCT00433381|141554572|OTHER|ROC analysis|Area Under the Curve (AUC)|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cr at 16 weeks||1|1|
71023695|NCT00433381|141554573|OTHER||||||||||||||||||The determination of treatment efficacy was to be made made based on the following rules: If 16 or more of the cases (16/57=28.1%) are progression free and alive at 6 months, then reject the null hypothesis that the rate is no better than 20%. If 15 or fewer of the cases (15/57=26.3%) are progression free and alive at 6 months, then reject the alternative hypothesis that the rate is at least 35%.|||
71023696|NCT00433381|141554575|OTHER|Agreement was assessed using a Kappa statistic|Kappa Statistic|0.39|||||TWO_SIDED|95.0|0.21|0.57||||||Agreement between Local and Central determinations 6-month PFS, based on imaging, was evaluated using Kappa statistics||0.57|0.21|
71023697|NCT00433381|141554576|OTHER|Sensitivity|Sensitivity|0.6|||||TWO_SIDED|95.0|0.46|0.73||||||Sensitivity||0.73|0.46|
71023698|NCT00433381|141554576|OTHER|Specificity|Specificity|0.78|||||TWO_SIDED|95.0|0.66|0.87||||||Specificity||0.87|0.66|
70934384|NCT01989793|141369647|EQUIVALENCE|Equivalence margin = 0||||||0.73|||||||Fisher Exact|||Fisher's exact test of percentage of participants with improvement in frailty score from baseline between treatment and placebo arms||||0.73
70934385|NCT01989793|141369648|EQUIVALENCE|Equivalence margin = 0||||||0.73|||||||Fisher Exact|||Fisher's exact test of percentage of participants with improvement in frailty score from baseline between treatment and placebo arms||||0.73
70934386|NCT04278833|141369675|OTHER||||||<|0.001||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at week 2||||<0.001
71023699|NCT00549198|141554595|SUPERIORITY_OR_OTHER|||||||0.435||95.0||||The model includes the following covariates: treatment, visit, baseline GFR by MDRD, baseline BMI, race group, treatment\*visit, baseline GFR by MDRD\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.435
71023700|NCT00549198|141554596|SUPERIORITY_OR_OTHER|||||||0.057||95.0||||The model includes the following covariates: treatment, visit, baseline GFR by MDRD, baseline BMI, race group, age group, treatment\*visit, baseline GFR by MDRD\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.057
71023701|NCT00549198|141554597|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||The model includes the following covariates: treatment, visit, baseline GFR by MDRD, baseline BMI, race group, treatment\*visit, baseline GFR by MDRD\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.060
71023702|NCT00549198|141554598|SUPERIORITY_OR_OTHER|||||||0.186||95.0||||The model includes the following covariates: treatment, visit, baseline GFR by CG, baseline BMI, race group, age group, hypertension, treatment\*visit, baseline GFR by CG\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.186
71023703|NCT00549198|141554599|SUPERIORITY_OR_OTHER|||||||0.413||95.0||||The model includes the following covariates: treatment, visit, baseline GFR by CG, baseline BMI, race group, age group, hypertension, treatment\*visit, baseline GFR by CG\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.413
71023704|NCT00549198|141554600|SUPERIORITY_OR_OTHER|||||||0.315||95.0||||The model includes the following covariates: treatment, visit, baseline GFR by CG, baseline BMI, race group, baseline CD4, treatment\*visit, baseline GFR by CG\*visit, baseline BMI\*visit and baseline CD4\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.315
71023705|NCT00549198|141554607|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The model includes the following covariates: treatment, visit, baseline spine BMD, baseline BMI, race group, age group, hypertension, treatment\*visit, baseline spine BMD\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||<0.001
71056922|NCT05013008|141618557|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX differences (corresponding to log-transformed ratio to baseline) of E-selectin (P16581) was analyzed.||||= 0.979
71056923|NCT05013008|141618557|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Thrombospondin-2 (P35442) was analyzed.||||= 0.979
71107995|NCT02949011|141721544|SUPERIORITY|||||||0.0081||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||144 hours||||0.0081
70934387|NCT04278833|141369675|OTHER||||||<|0.001||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 3||||<0.001
70934388|NCT04278833|141369675|OTHER||||||<|0.001||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 6||||<0.001
70934389|NCT04278833|141369676|OTHER|||||||0.28||||||The a priori threshold for statistical significance was \<0.05.|Chi-squared|||Analysis of change at week 2||||0.280
71023706|NCT00549198|141554608|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The model includes the following covariates: treatment, visit, baseline hip BMD, baseline BMI, race group, risk factor, country group, treatment\*visit, baseline hip BMD\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||<0.001
71023707|NCT00549198|141554609|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||The model includes the following covariates: treatment, visit, baseline spine BMD, baseline BMI, race group, age group, treatment\*visit, baseline spine BMD\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.036
71023708|NCT00549198|141554610|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The model includes the following covariates: treatment, visit, baseline hip BMD, baseline BMI, race group, risk factor, prohibited medication, previous fracture, treatment\*visit, baseline hip BMD\*visit and baseline BMI\*visit.|Mixed Models Analysis|Correlation matrix for within-subject errors is unstructured.||||||<0.001
70934390|NCT04278833|141369676|OTHER|||||||0.07||||||The a priori threshold for statistical significance was \<0.05.|Chi-squared|||Analysis of change at month 3||||0.070
70934391|NCT04278833|141369676|OTHER|||||||0.851||||||The a priori threshold for statistical significance was \<0.05.|Chi-squared|||Analysis of change at month 6||||0.851
70934392|NCT04278833|141369677|OTHER||||||<|0.001||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at week 2||||<0.001
70934393|NCT04278833|141369677|OTHER|||||||0.021||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 3||||0.021
70934394|NCT04278833|141369677|OTHER|||||||0.044||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 6||||0.044
70934395|NCT04278833|141369678|OTHER|||||||0.226||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at week 2||||0.226
71023709|NCT00549198|141554611|SUPERIORITY_OR_OTHER|||||||0.112||95.0||||The model includes the following covariates: treatment, visit, baseline spine BMD, baseline BMI, race group, age group, treatment\*visit, baseline spine BMD\*visit and baseline BMI\*visit.|Mixed Models Analysis|correlation matrix for within-subject errors is unstructured.||||||0.112
71023710|NCT00549198|141554612|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The model includes the following covariates: treatment, visit, baseline hip BMD, baseline BMI, race group, risk factor, prohibited medication, previous fracture, treatment\*visit, baseline hip BMD\*visit, and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||<0.001
71023711|NCT00549198|141554645|SUPERIORITY_OR_OTHER|||||||0.3025||95.0||||The model includes the following covariates: treatment, age, baseline biomarker value, and gender.|ANOVA|Estimates are calculated from an ANOVA model. Parameters are analyzed based on log transformed data.||||||0.3025
71023712|NCT00549198|141554646|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The model includes the following covariates: treatment, age, baseline biomarker value, baseline CD4, and gender.|ANOVA|Estimates are calculated from an ANOVA model. Parameters are analyzed based on log transformed data.||||||<0.0001
71023713|NCT00549198|141554647|SUPERIORITY_OR_OTHER|||||||0.3323||95.0||||The model includes the following covariates: treatment, age, and baseline biomarker value.|ANOVA|Estimates are calculated from an ANOVA model. Parameters are analyzed based on log transformed data.||||||0.3323
71023714|NCT00549198|141554648|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The model includes the following covariates: treatment, baseline biomarker value, baseline CD4, and gender.|ANOVA|Estimates are calculated from an ANOVA model. Parameters are analyzed based on log transformed data.||||||<0.0001
71023715|NCT00549198|141554649|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The model includes the following covariates: treatment, age, and baseline biomarker value.|ANOVA|Estimates are calculated from ana ANOVA model. Parameters are analyzed based on log transformed data.||||||<0.0001
71023716|NCT00549198|141554650|SUPERIORITY_OR_OTHER|||||||0.0019||95.0||||The model includes the following covariates: treatment, baseline biomarker value, and gender.|ANOVA|Estimates are calculated from an ANOVA model.||||||0.0019
71023717|NCT00549198|141554651|SUPERIORITY_OR_OTHER|||||||0.0019||95.0||||The model includes the following covariates: treatment, age, baseline biomarker value, and baseline CD4.|ANOVA|Estimates are calculated from an ANOVA model.||||||0.0019
71023718|NCT00549198|141554652|SUPERIORITY_OR_OTHER|||||||0.0266||95.0||||The model includes the following covariates: treatment, baseline biomarker value, and baseline CD4.|ANOVA|Estimates are calculated from an ANOVA model.||||||0.0266
71056924|NCT05013008|141618557|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of RARRES2 (Q99969) was analyzed.||||= 0.979
71023719|NCT00472446|141554653|SUPERIORITY_OR_OTHER|||||||0.028|||||||t-test, 2 sided|||null hypothesis: no difference in outcome measure between superficial cervical block and placebo treatment (irrespective of timing of treatment)||||.028
71056925|NCT05013008|141618557|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of C-X-C motif chemokine 16 (Q9H2A7) was analyzed.||||= 0.979
71056926|NCT05013008|141618557|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Dickkopf-related protein 3 (Q9UBP4) was analyzed.||||= 0.979
71056927|NCT02207634|141618600|NON_INFERIORITY|The non-inferiority margin was 0.19, calculated as 20% of the observed common standard deviation, which was estimated from observations in the placebo group by a repeated measured mixed-effect linear model with visit as a covariate. If the upper bound of the 95% CI for the difference between the placebo and evolocumab group in mean change from baseline for Z score averaged across the visits was less than the non-inferiority margin non-inferiority criteria were met.|Treatment Difference|0.0072|STANDARD_ERROR_OF_MEAN|0.0375|||TWO_SIDED|95.0|-0.0664|0.0808||||||A repeated measures mixed-effect linear model was used to estimate treatment difference (placebo - evolocumab) in change from baseline and associated 95% confidence intervals (CI). The model included stratification factors for Study 20110118 (final screening low-density lipoprotein cholesterol \[LDL-C\] and geographical region), age, education level, baseline SWM strategy index Z score, treatment group, visit, and treatment by visit interaction.||0.0808|-0.0664|
71023720|NCT00472446|141554654|SUPERIORITY_OR_OTHER|||||||0.016|||||||Non-parametric ANOVA-type statistic|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||null hypothesis: no difference in outcome measure between superficial cervical block and placebo treatment (irrespective of timing of treatment)||||0.016
71023721|NCT00472446|141554654|SUPERIORITY_OR_OTHER|||||||0.723|||||||Non-parametric ANOVA-type statistic|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||null hypothesis: no difference in outcome measure pre-operative versus post-operative application||||0.723
71023722|NCT00472446|141554656|SUPERIORITY_OR_OTHER|||||||0.94|TWO_SIDED||||||Fisher Exact|mid p value of the two-sided Fisher test||"null hypothesis: outcome measure (Proportion of patients taking analgetics) is equal between superficial cervical block and placebo treatment (irrespective of timing)~Proportion taking Paracetamol:"||||0.94
71023723|NCT00472446|141554656|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Fisher Exact|mid p value of two-sided Fisher test||"null hypothesis: outcome measure (Proportion of patients taking analgetics) is equal between superficial cervical block and placebo treatment (irrespective of timing)~Proportion taking Metamizole:"||||0.58
71056928|NCT02207634|141618601|OTHER||Treatment Difference|0.0333|STANDARD_ERROR_OF_MEAN|0.0363|||TWO_SIDED|95.0|-0.0378|0.1045||||||A repeated measures mixed-effect linear model was used to estimate treatment difference (placebo - evolocumab) in change from baseline and associated 95% confidence intervals (CI). The model included stratification factors for Study 20110118 (final screening LDL-C and geographical region), age, education level, baseline SWM between-errors Z score, treatment group, visit, and treatment by visit interaction.||0.1045|-0.0378|
71056929|NCT02207634|141618602|OTHER||Treatment Difference|0.0226|STANDARD_ERROR_OF_MEAN|0.033|||TWO_SIDED|95.0|-0.0422|0.0873||||||A repeated measures mixed-effect linear model was used to estimate treatment difference (placebo - evolocumab) in change from baseline and associated 95% confidence intervals (CI). The model included stratification factors for Study 20110118 (final screening LDL-C and geographical region), age, education level, baseline PAL total errors adjusted Z score, treatment group, visit, and treatment by visit interaction.||0.0873|-0.0422|
71056930|NCT02207634|141618603|OTHER||Treatment Difference|0.0727|STANDARD_ERROR_OF_MEAN|0.0382|||TWO_SIDED|95.0|-0.0022|0.1477||||||A repeated measures mixed-effect linear model was used to estimate treatment difference ( placebo - evolocumab) in change from baseline and associated 95% confidence intervals (CI). The model included stratification factors for Study 20110118 (final screening LDL-C and geographical region), age, education level, baseline RTI median 5-choice reaction time Z score, treatment group, visit, and treatment by visit interaction.||0.1477|-0.0022|
71056931|NCT00591773|141618614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.86|||<|0.001|TWO_SIDED|95.0|-18.54|-13.19||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-13.19|-18.54|<0.001
71056932|NCT00591773|141618614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.45|||<|0.001|TWO_SIDED|95.0|-18.13|-12.76||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-12.76|-18.13|<0.001
71056933|NCT00591773|141618615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.4|||<|0.001|TWO_SIDED|95.0|-17.81|-10.99||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-10.99|-17.81|<0.001
71023724|NCT00472446|141554657|SUPERIORITY_OR_OTHER|||||||0.328|TWO_SIDED||||||Non-parametric ANOVA-type|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||"null hypothesis: no difference in pooled dose of analgetics, superficial block versus Placebo~outcome: paracetamol"||||0.328
71023725|NCT00472446|141554657|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||Non-parametric ANOVA-type|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||"null hypothesis: no difference in pooled dose of analgetics, superficial block versus Placebo~outcome: metamizole"||||0.81
71023726|NCT00472446|141554657|SUPERIORITY_OR_OTHER|||||||0.331|TWO_SIDED||||||Non-parametric ANOVA-type statistic|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||"null hypothesis: no difference in outcome measure pre-operative and post-operative application~outcome measure: pooled paracetamol dose"||||0.331
71023727|NCT00472446|141554657|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||Non-parametric ANOVA-type statistic|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||"null hypothesis: no difference in outcome measure pre-operative and post-operative application~outcome measure: pooled metamizole dose"||||0.440
71023728|NCT00472446|141554658|SUPERIORITY_OR_OTHER|||||||0.925|TWO_SIDED||||||non-parametric ANOVA-type statistic|non-parametric ANOVA-type statistic for pooled main effects, full model||null hypothesis: no difference in outcome measure for superficial cervical block versus placebo treatment||||0.925
71023729|NCT01165684|141554659|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% CI was below or equal to 0.4% or equivalently if the p-value for the one-sided test of was less than or equal to 2.5%, where D is the mean treatment difference (step-wise regimen minus basal-bolus regimen).|Estimated treatment difference, Mean|0.14||||0.088||95.0|-0.02|0.3|||Regression, Linear|||||0.30|-0.02|0.088
71023730|NCT01165684|141554660|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|0.55|||<|0.001||95.0|0.42|0.69|||Regression, Linear|||||0.69|0.42|<0.001
71023731|NCT01165684|141554661|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|0.37|||<|0.001||95.0|0.21|0.53|||Regression, Linear|||||0.53|0.21|<0.001
71023732|NCT01165684|141554662|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.85|||<|0.001||95.0|4.12|11.39|||Regression, Logistic|||||11.39|4.12|<0.001
71023733|NCT01165684|141554663|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38|||<|0.001||95.0|1.56|3.64|||Regression, Logistic|||||3.64|1.56|<0.001
71023734|NCT01165684|141554664|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.146||95.0|0.9|2.07|||Regression, Logistic|||||2.07|0.90|0.146
71056934|NCT00591773|141618615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.68|||<|0.001|TWO_SIDED|95.0|-16.1|-9.25||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-9.25|-16.10|<0.001
71056935|NCT00591773|141618616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.29|||<|0.001|TWO_SIDED|95.0|-12.02|-8.56||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.56|-12.02|<0.001
70934396|NCT04278833|141369678|OTHER|||||||0.071||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 3||||0.071
71023735|NCT01165684|141554667|SUPERIORITY_OR_OTHER||Estimated Mean|0.12||||0.635||95.0|-0.37|0.6|||Regression, Linear|||||0.60|-0.37|0.635
71023736|NCT01165684|141554670|SUPERIORITY_OR_OTHER||Estimated mean|0.36||||0.046||95.0|0.01|0.71|||Regression, Linear|||||0.71|0.01|0.046
71023737|NCT01165684|141554671|SUPERIORITY_OR_OTHER||Estimated mean|-0.48||||0.228||95.0|-1.25|0.3|||Regression, Linear|||||0.30|-1.25|0.228
70934397|NCT04278833|141369678|OTHER|||||||0.382||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 6||||0.382
70934398|NCT04278833|141369679|OTHER|||||||0.152||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at week 2||||0.152
70934399|NCT04278833|141369679|OTHER|||||||0.261||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 3.||||0.261
71056936|NCT00591773|141618616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.49|||<|0.001|TWO_SIDED|95.0|-12.23|-8.76||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.76|-12.23|<0.001
71056937|NCT00591773|141618617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.25|||<|0.001|TWO_SIDED|95.0|-9.25|-5.25||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.25|-9.25|<0.001
70934400|NCT04278833|141369679|OTHER|||||||0.437||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 6.||||0.437
71056938|NCT00591773|141618617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.05|||<|0.001|TWO_SIDED|95.0|-9.06|-5.05||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.05|-9.06|<0.001
71056939|NCT00591773|141618618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|||<|0.001|TWO_SIDED|95.0|-19.56|-14.04||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-14.04|-19.56|<0.001
71056940|NCT00591773|141618618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.24|||<|0.001|TWO_SIDED|95.0|-19.01|-13.47||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-13.47|-19.01|<0.001
71107996|NCT02949011|141721544|SUPERIORITY|||||||0.7425||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||144 hours||||0.7425
71107997|NCT02949011|141721544|SUPERIORITY|||||||0.0209||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||168 hours||||0.0209
70934401|NCT04278833|141369680|OTHER|||||||0.128||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.128
70934402|NCT04278833|141369680|OTHER||||||>|0.999||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||>0.999
71023738|NCT01165684|141554672|SUPERIORITY_OR_OTHER||Estimated mean|-0.17||||0.224||95.0|-0.45|0.11|||Regression, Linear|||||0.11|-0.45|0.224
71023739|NCT01797120|141554733|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.02|TWO_SIDED|95.0|0.4|0.92|||Log Rank|Log rank test was stratified on ECOG performance status, measurable disease, and prior chemotherapy for metastatic disease||||0.92|0.40|0.02
71023740|NCT01797120|141554734|SUPERIORITY|||||||0.01|||||||Fisher Exact|||||||0.01
70934403|NCT04278833|141369681|OTHER|||||||0.04||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.040
70934404|NCT04278833|141369681|OTHER||||||>|0.999||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||>0.999
70934405|NCT02609048|141369715|SUPERIORITY||Difference in LSM|-60.99|STANDARD_ERROR_OF_MEAN|5.814|<|0.0001|TWO_SIDED|95.0|-72.85|-49.13||Difference in mean,p-value, and CIs estimated by comparing Seladelpar level with placebo by ANCOVA model.Treatment group as factor,baseline AP assessment as covariate,and percent change from baseline as response variable.|ANCOVA|||||-49.13|-72.85|<0.0001
70934406|NCT02609048|141369715|SUPERIORITY||Difference in Least Squares Mean (LSM)|-51.37|STANDARD_ERROR_OF_MEAN|5.849|<|0.0001|TWO_SIDED|95.0|-63.3|-39.44||Difference in mean,p-value, and confidence intervals (CIs) estimated by comparing Seladelpar level with placebo by ANCOVA model.Treatment group as factor,baseline AP assessment as covariate,and percent change from baseline as response variable.|ANCOVA|||||-39.44|-63.30|<0.0001
70934407|NCT02609048|141369715|SUPERIORITY||Difference in Least Squares Mean (LSM)|-9.62|STANDARD_ERROR_OF_MEAN|5.963||0.1167|TWO_SIDED|95.0|-21.79|2.54||Difference in mean,p-value, and CIs estimated by comparing Seladelpar 200 mg versus 50 mg by ANCOVA model.Treatment group as factor,baseline AP assessment as covariate,and percent change from baseline as response variable.|ANCOVA|||||2.54|-21.79|0.1167
71023741|NCT01797120|141554735|SUPERIORITY|||||||0.47|||||||Fisher Exact|||||||0.47
71023742|NCT02462421|141554737|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.92||||||No adjustment for multiple comparisons. Viewed as unnecessary inasmuch as none of the comparisons achieved p\<0.05.|t-test, 2 sided|||"Each of the variant genotypes was compared to the control group (homozygous for major alleles at all three genetic loci) in an unpaired t-test. The study was terminated early because it was clear that we would not meet our recruitment targets and that the study was likely underpowered.~Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant."||||0.92
70934408|NCT02609048|141369716|SUPERIORITY||||||<|0.0001||||||The p-values were calculated from Fisher's exact test comparing each Seladelpar group with Placebo separately.|Fisher Exact|||||||<0.0001
71056941|NCT00591773|141618619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.02|||<|0.001|TWO_SIDED|95.0|-12.86|-9.18||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.18|-12.86|<0.001
71056942|NCT00591773|141618619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.2|||<|0.001|TWO_SIDED|95.0|-13.04|-9.35||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.35|-13.04|<0.001
71056943|NCT00591773|141618620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.93|||<|0.001|TWO_SIDED|95.0|-15.92|-9.94||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.94|-15.92|<0.001
71023743|NCT02462421|141554737|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.63||||||Not corrected for multiple comparisons|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.63
71023744|NCT02462421|141554737|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.86||||||Not adjusted for multiple comparisons|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.86
71023745|NCT02462421|141554738|OTHER|"We compared the two groups (wild type versus SLC2A9 variant homozygotes. Null hypothesis: there are no differences between the two groups with respect to the pharmacodynamic effect of canagliflozin on fractional excretion of uric acid in the urine."||||||0.04||||||Because the study was terminated early, we did not have sufficient statistical power to adjust for multiple comparisons. We are reporting a nominal p-value without adjusting for multiple comparisons|t-test, 2 sided|||The study was terminated early because of slow recruitment. As a result the study did not achieve the statistical power that had been planned.||||0.04
71023746|NCT02462421|141554739|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.07||||||Not corrected for multiple comparisons|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.07
71023747|NCT02462421|141554739|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.53||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.53
71023748|NCT02462421|141554739|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.92||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.92
71023749|NCT02462421|141554740|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.|||||<|0.01||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||<0.01
71023750|NCT02462421|141554740|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.77||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.77
71107998|NCT02949011|141721544|SUPERIORITY|||||||0.7448||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||168 hours||||0.7448
71023751|NCT02462421|141554740|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.65||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.65
71023752|NCT02462421|141554741|OTHER|Null hypothesis: None of the three genotypes is associated with an alteration in the pharmacodynamic effect of canagliflozin on urinary Na excretion||||||0.2||||||Because the study was terminated early, the study does not have sufficient statistical power to adjust for multiple comparisons. Accordingly, nominal p-values are reported.|t-test, 2 sided|||"The wild type genotype group was compared to homozygotes for each of the three other genotypes."||||0.20
71023753|NCT02462421|141554741|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.01|||||||t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.01
71023754|NCT02462421|141554741|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.16||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.16
71023755|NCT02462421|141554742|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.21||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.21
70934409|NCT02609048|141369716|SUPERIORITY|||||||0.0036||||||The p-values were calculated from Fisher's exact test comparing each Seladelpar group with Placebo separately.|Fisher Exact|||||||0.0036
71023756|NCT02462421|141554742|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.92||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.92
71023757|NCT02462421|141554742|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.39||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Not corrected for multiple comparisons.||||0.39
71023758|NCT01339910|141554766|SUPERIORITY||Difference in 18 month OS (MAC-RIC)|9.8||||0.07|TWO_SIDED|95.0|-0.8|20.3||This final test was performed at a 0.049 significance level, since 0.001 was spent at interim analyses and the overall significance level was 0.050.|Difference in Kaplan-Meier estimators|||The null hypothesis is that there is no difference in overall survival at 18 months post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. 18 month overall survival was compared between treatment arms using the difference in Kaplan-Meier estimators, which should be close to 0 under the null hypothesis.||20.3|-0.8|0.07
71107999|NCT02949011|141721544|SUPERIORITY|||||||0.0644||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||192 hours||||0.0644
70934410|NCT02609048|141369716|SUPERIORITY|||||||0.1045||||||The p-values were calculated from Fisher's exact test comparing Seladelpar 200mg versus 50 mg.|Fisher Exact|||||||0.1045
71023759|NCT01339910|141554767|SUPERIORITY||Difference in 18 month RFS (MAC-RIC)|20.4|||<|0.01|TWO_SIDED|95.0|8.9|32.0||Test performed at a significance level of 0.05|Difference in Kaplan-Meier estimators|||The null hypothesis is that there is no difference in relapse-free survival at 18 months post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. 18 month relapse-free survival was compared between treatment arms using the difference in Kaplan-Meier estimators, which should be close to 0 under the null hypothesis.||32.0|8.9|< 0.01
71023760|NCT01339910|141554768|SUPERIORITY||||||<|0.001||||||Test performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of disease relapse during the first 18 months post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of disease relapse was compared between treatment arms using Gray's test, treating death as a competing risk.||||< 0.001
71023761|NCT01339910|141554769|SUPERIORITY|||||||0.002||||||Test performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of treatment-related mortality during the first 18 months post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of treatment-related mortality was compared between treatment arms using Gray's test, treating disease relapse as a competing risk.||||0.002
71023762|NCT01339910|141554770|SUPERIORITY|||||||0.002||||||Test performed at a significance level of 0.05|Difference in Aalen-Johansen estimators|||The null hypothesis is that there is no difference in the cumulative incidence of neutrophil engraftment at Day 28 post-transplant between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of neutrophil engraftment at Day 28 was compared between treatment arms using the difference in Aalen-Johansen estimators, which should be close to 0 under the null hypothesis. Death was treated as a competing risk.||||0.002
71023763|NCT01339910|141554770|SUPERIORITY|||||||0.065||||||Test performed at a significance level of 0.05|Difference in Aalen-Johansen estimators|||The null hypothesis is that there is no difference in the cumulative incidence of platelet engraftment at Day 60 post-transplant between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of platelet engraftment at Day 60 was compared between treatment arms using the difference in Aalen-Johansen estimators, which should be close to 0 under the null hypothesis. Death was treated as a competing risk.||||0.065
71023764|NCT01339910|141554771|SUPERIORITY|||||||0.005||||||Test performed at a significance level of 0.05|Chi-squared|3 degrees of freedom||The null hypothesis is that there is no difference in the proportions of participants with full chimerism, mixed chimerism, graft rejection, and death prior to assessment at Day 28 post-transplant between AML/MDS participants receiving MAC and RIC conditioning regimens.||||0.005
71023765|NCT01339910|141554771|SUPERIORITY|||||||0.011||||||Test performed at a significance level of 0.05|Chi-squared|3 degrees of freedom||The null hypothesis is that there is no difference in the proportions of participants with full chimerism, mixed chimerism, graft rejection, and death prior to assessment at Day 100 post-transplant between AML/MDS participants receiving MAC and RIC conditioning regimens.||||0.011
71023766|NCT01339910|141554771|SUPERIORITY|||||||0.39||||||Test performed at a significance level of 0.05|Chi-squared|3 degrees of freedom||The null hypothesis is that there is no difference in the proportions of participants with full chimerism, mixed chimerism, graft rejection, and death prior to assessment at 18 months post-transplant between AML/MDS participants receiving MAC and RIC conditioning regimens.||||0.39
71023767|NCT01339910|141554772|SUPERIORITY|||||||0.024||||||Test performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of grade II-IV acute GVHD during the first 100 days post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of grade II-IV acute GVHD was compared between treatment arms using Gray's test, treating death as a competing risk.||||0.024
70934411|NCT02609048|141369717|SUPERIORITY||Difference in LSM|234.71|STANDARD_ERROR_OF_MEAN|104.647||0.0322|TWO_SIDED|95.0|21.28|448.14||Difference between means, p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline AST assessment as covariate,and percent change from baseline in AST as response variable.|ANCOVA|||||448.14|21.28|0.0322
70934412|NCT02609048|141369717|SUPERIORITY||Difference in LSM|132.82|STANDARD_ERROR_OF_MEAN|96.015||0.1764|TWO_SIDED|95.0|-63.0|328.65||Difference between means, p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline AST assessment as covariate,and percent change from baseline in AST as response variable.|ANCOVA|||||328.65|-63.00|0.1764
71023768|NCT01339910|141554772|SUPERIORITY|||||||0.066||||||Test performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of grade III-IV acute GVHD during the first 100 days post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of grade III-IV acute GVHD was compared between treatment arms using Gray's test, treating death as a competing risk.||||0.066
71056944|NCT00591773|141618620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.84|||<|0.001|TWO_SIDED|95.0|-15.83|-9.84||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.84|-15.83|<0.001
71056945|NCT00591773|141618621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.16|||<|0.001|TWO_SIDED|95.0|-10.14|-6.19||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.19|-10.14|<0.001
71056946|NCT00591773|141618621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.17|||<|0.001|TWO_SIDED|95.0|-10.15|-6.19||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.19|-10.15|<0.001
71056947|NCT00591773|141618622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.52|||<|0.001|TWO_SIDED|95.0|-20.39|-14.64||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-14.64|-20.39|<0.001
71056948|NCT00591773|141618622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.95|||<|0.001|TWO_SIDED|95.0|-19.84|-14.05||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-14.05|-19.84|<0.001
71023769|NCT01339910|141554773|SUPERIORITY|||||||0.019||||||Test performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of chronic GVHD during the first 18 months post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of chronic GVHD was compared between treatment arms using Gray's test, treating death as a competing risk.||||0.019
70934413|NCT02609048|141369717|SUPERIORITY||Difference in LSM|101.88|STANDARD_ERROR_OF_MEAN|103.504||0.3326|TWO_SIDED|95.0|-109.21|312.98||Difference between means, p-value, and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor, baseline AST assessment as covariate, and percent change from baseline in AST as response variable.|ANCOVA|||||312.98|-109.21|0.3326
71023770|NCT05117099|141554827|SUPERIORITY|||||||0.548|||||||ANOVA|||||||.548
71056949|NCT00591773|141618623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.54|||<|0.001|TWO_SIDED|95.0|-13.49|-9.59||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.59|-13.49|<0.001
71056950|NCT00591773|141618623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.68|||<|0.001|TWO_SIDED|95.0|-13.64|-9.72||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.72|-13.64|<0.001
71056951|NCT00591773|141618624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.04|||<|0.001|TWO_SIDED|95.0|-17.13|-10.94||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-10.94|-17.13|<0.001
71056952|NCT00591773|141618624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.48|||<|0.001|TWO_SIDED|95.0|-16.58|-10.37||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-10.37|-16.58|<0.001
71056953|NCT00591773|141618625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.42|||<|0.001|TWO_SIDED|95.0|-11.65|-7.2||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.20|-11.65|<0.001
71056954|NCT00591773|141618625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.69|||<|0.001|TWO_SIDED|95.0|-11.92|-7.46||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.46|-11.92|<0.001
70934414|NCT02609048|141369718|SUPERIORITY||Difference in LSM|185.78|STANDARD_ERROR_OF_MEAN|104.379||0.0849|TWO_SIDED|95.0|-27.1|398.66||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as a factor, baseline ALT assessment as covariate,and percent change from baseline in ALT as response variable.|ANCOVA|||||398.66|-27.10|0.0849
70934415|NCT02609048|141369718|SUPERIORITY||Difference in LSM|116.5|STANDARD_ERROR_OF_MEAN|97.437||0.2409|TWO_SIDED|95.0|-82.22|315.23||Difference between means,p-value,and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as a factor,baseline ALT assessment as covariate, and percent change from baseline in ALT as response variable.|ANCOVA|||||315.23|-82.22|0.2409
70934416|NCT02609048|141369718|SUPERIORITY||Difference in LSM|69.28|STANDARD_ERROR_OF_MEAN|105.295||0.5154|TWO_SIDED|95.0|-145.47|284.03||Difference between means,p-value,and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as a factor,baseline ALT assessment as covariate, and percent change from baseline in ALT as response variable.|ANCOVA|||||284.03|-145.47|0.5154
70934417|NCT02609048|141369719|SUPERIORITY||Difference in LSM|-45.34|STANDARD_ERROR_OF_MEAN|12.112||0.0007|TWO_SIDED|95.0|-70.04|-20.64||Difference between means, p-value,and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as a factor, baseline GGT assessment as covariate,and percent change from baseline in GGT as response variable.|ANCOVA|||||-20.64|-70.04|0.0007
71023771|NCT05117099|141554829|SUPERIORITY|||||||0.915|||||||ANOVA|||||||.915
71023772|NCT05117099|141554830|SUPERIORITY|||||||0.663|||||||ANOVA|||||||.663
71023773|NCT05117099|141554831|SUPERIORITY|||||||0.138|||||||ANOVA|||||||.138
71023774|NCT05117099|141554832|SUPERIORITY|||||||0.114|||||||ANOVA|||||||.114
71023775|NCT05117099|141554833|SUPERIORITY|||||||0.065|||||||ANOVA|||||||.065
71023776|NCT05117099|141554834|SUPERIORITY|||||||0.394|||||||ANOVA|||||||.394
71023777|NCT05117099|141554835|SUPERIORITY|||||||0.388|||||||ANOVA|||||||.388
71023778|NCT05117099|141554836|SUPERIORITY|||||||0.332|||||||ANOVA|||||||.332
71023779|NCT03151499|141554856|OTHER||Geometric mean (gMean) ratio (%)|7.8|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|90.0|5.74|10.601|||||gMean ratio = BI 409306 + Rifampicin pretreatment (T) / BI 409306 (R). Standard Error of the mean is actually the Geometric Standard Error.|The main focus is on estimation, therefore no hypothesis was tested. The statistical analysis model for the primary endpoints is an ANOVA (analysis of variance). This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' will be considered as random, whereas the treatment effect will be considered as fixed. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model.||10.601|5.740|
71023780|NCT03151499|141554857|OTHER||Geometric mean (gMean) ratio (%)|9.77|STANDARD_ERROR_OF_MEAN|1.232|||TWO_SIDED|90.0|6.767|14.098|||||gMean ratio = BI 409306 + Rifampicin pretreatment (T) / BI 409306 (R). Standard Error of the mean is actually the Geometric Standard Error.|The main focus is on estimation, therefore no hypothesis was tested. The statistical analysis model for the primary endpoints is an ANOVA (analysis of variance). This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' will be considered as random, whereas the treatment effect will be considered as fixed. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model.||14.098|6.767|
71056955|NCT00591773|141618626|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.09|||<|0.001|TWO_SIDED|95.0|2.38|7.03||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||7.03|2.38|<0.001
71056956|NCT00591773|141618626|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.001|TWO_SIDED|95.0|1.82|5.03||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||5.03|1.82|<0.001
71023781|NCT03151499|141554858|OTHER||Geometric mean (gMean) ratio (%)|8.23|STANDARD_ERROR_OF_MEAN|1.187|||TWO_SIDED|90.0|6.081|11.126|||||gMean ratio = BI 409306 + Rifampicin pretreatment (T) / BI 409306 (R). Standard Error of the mean is actually the Geometric Standard Error.|Since the main focus is on estimation and not testing, therefore no hypothesis was tested.The statistical analysis model is an ANOVA (analysis of variance) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' will be considered as random, whereas the treatment effect will be considered as fixed. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model.||11.126|6.081|
71023782|NCT00125931|141554859|SUPERIORITY_OR_OTHER|||||||0.01|ONE_SIDED|95.0|||||ANOVA|||comparison of mean scores at hour 2 vs 3||||0.01
71023783|NCT00125931|141554860|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 1 sided|||comparison of mean score on treatment vs post-treatment days||||0.01
71023784|NCT00125931|141554860|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||t-test, 1 sided|||comparison of mean scores at pre-treatment vs treatment days||||0.4
71023785|NCT03654898|141554883|SUPERIORITY||cross-tabulation|0.48||||0.49|TWO_SIDED||||||Chi-squared|||||||0.49
71023786|NCT03654898|141554883|SUPERIORITY||Odds Ratio (OR)|1.06||||0.67|TWO_SIDED|95.0|0.8|1.42|||Regression, Logistic|Adjusted logistic regression||||1.42|0.80|0.67
71023787|NCT03654898|141554884|SUPERIORITY||Cross-tabulation|0.71||||0.4|TWO_SIDED||||||Chi-squared|||||||0.40
71023788|NCT03654898|141554885|SUPERIORITY||Cross-tabulation|0.5||||0.78|TWO_SIDED||||||Chi-squared|||Test 1 was for TFVdp while test 2 was for 3TCtp.||||0.78
71023789|NCT03654898|141554885|SUPERIORITY||Cross-tabulation|2.13||||0.34|TWO_SIDED||||||Chi-squared|||Test 2 was for 3TCtp while test 1 was for TFVdp.||||0.34
71023790|NCT01504867|141554933|SUPERIORITY_OR_OTHER|||||||0.53|||||||Wald|This was a large sample (Wald) test estimated using a conditional logistic regression model with site as a stratification variable.||The primary outcome significance level was adjusted for multiple testing associated with the interim analysis. Its significance level is 92.6%||||0.53
70934418|NCT02609048|141369719|SUPERIORITY||Difference in LSM|-40.78|STANDARD_ERROR_OF_MEAN|11.033||0.0008|TWO_SIDED|95.0|-63.28|-18.28||Difference between means, p-value,and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as a factor, baseline GGT assessment as covariate,and percent change from baseline in GGT as response variable.|ANCOVA|||||-18.28|-63.28|0.0008
71023791|NCT01504867|141554934|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Chi-squared|||||||>0.99
71023792|NCT01504867|141554935|SUPERIORITY_OR_OTHER|||||||0.36|||||||Chi-squared|||||||0.36
71108000|NCT02949011|141721544|SUPERIORITY|||||||0.4931||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||192 hours||||0.4931
71023793|NCT01504867|141554936|SUPERIORITY_OR_OTHER|||||||0.23|||||||Chi-squared|||||||0.23
71023794|NCT01504867|141554937|SUPERIORITY_OR_OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
71023795|NCT01504867|141554938|SUPERIORITY_OR_OTHER|||||||0.08|||||||Chi-squared|||||||0.08
71023796|NCT01504867|141554939|SUPERIORITY_OR_OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
71023797|NCT02151461|141554956|OTHER|A mixed-effects model for analysis of covariance (ANCOVA) was used to analyze changes from Baseline in plasma glucose AUC(0-3hr) at Week 4 in the Day 28 Evaluable population. The model includes factors for treatment group and fasting plasma glucose stratum.||||||0.0435||||||Baseline plasma glucose AUC(0-3hr) is adjusted as a covariate.|ANCOVA|||||||0.0435
71023798|NCT02151461|141554956|OTHER|||||||0.065|||||||ANCOVA|||||||0.065
71023799|NCT02151461|141554956|OTHER|||||||0.1216|||||||ANCOVA|||||||0.1216
71023800|NCT02151461|141554957|OTHER|A mixed-effects model for analysis of covariance (ANCOVA) was used to analyze changes from Baseline in incremental plasma glucose AUC at Week 4 in the Day 28 Evaluable population. The model will include factors for treatment group and fasting plasma glucose stratum.||||||0.8867|||||||ANCOVA|The model includes factors for treatment group and fasting plasma glucose stratum.||||||0.8867
71023801|NCT02151461|141554957|OTHER|||||||0.7641|||||||ANCOVA|||||||0.7641
71023802|NCT02151461|141554957|OTHER|||||||0.2518|||||||ANCOVA|||||||0.2518
71023803|NCT02151461|141554958|OTHER|||||||0.0179|||||||ANCOVA|Total daily dose is twice the respective dose, Pairwise comparison using Treatment D as the reference group||||||0.0179
71023804|NCT02151461|141554958|OTHER|||||||0.0736|||||||ANCOVA|||||||0.0736
71023805|NCT02151461|141554958|OTHER|||||||0.0475|||||||ANCOVA|||||||0.0475
71023806|NCT02151461|141554959|OTHER|||||||0.0089|||||||ANCOVA|Total daily dose is twice the respective dose. Pairwise Comparison using Treatment D as the Reference Group||||||0.0089
71023807|NCT02151461|141554959|OTHER|||||||0.376|||||||ANCOVA|||||||0.376
71023808|NCT02151461|141554959|OTHER|||||||0.0578|||||||ANCOVA|||||||0.0578
71023809|NCT02151461|141554960|OTHER|||||||0.2177|||||||ANCOVA|Total daily dose is twice the respective dose. Pairwise Comparison using Treatment D as the Reference Group||The HOMA Calculator,is an algorithm that takes account of variations in hepatic and peripheral glucose resistance, increases in insulin secretion curve for plasma glucose concentrations above 10 mmol/L (180 mg/dL), and contribution of circulating proinsulin (eg, C-peptide) to estimate steady state beta cell function (%HOMA-B) and insulin sensitivity (%HOMA-S), as percentages of a normal reference population. %HOMA-IR was analyzed on a logarithmic scale (natural logarithmic transformation).||||0.2177
71023810|NCT02151461|141554960|OTHER|||||||0.4144|||||||ANCOVA|||||||0.4144
71023811|NCT02151461|141554960|OTHER|||||||0.3117|||||||ANCOVA|||||||0.3117
71023812|NCT02151461|141554961|OTHER|Average Change in Pre-meal Glucose Level||||||0.011|||||||ANCOVA|Total daily dose is twice the respective dose Pairwise comparison using Treatment D as the reference group||||||0.011
71023813|NCT02151461|141554961|OTHER|Average Change in Pre-meal Glucose Level||||||0.0152|||||||ANCOVA|||||||0.0152
71023814|NCT02151461|141554961|OTHER|Average Change in Pre-meal Glucose Level||||||0.0284|||||||ANCOVA|||||||0.0284
71023815|NCT02151461|141554961|OTHER|Average Change in Post-meal Glucose Level||||||0.1273|||||||ANCOVA|Total daily dose is twice the respective dose Pairwise comparison using Treatment D as the reference group||||||0.1273
71023816|NCT02151461|141554961|OTHER|Average Change in Post-meal Glucose Level||||||0.0085|||||||ANCOVA|||||||0.0085
71023817|NCT02151461|141554961|OTHER|Average Change in Post-meal Glucose Level||||||0.1289|||||||ANCOVA|||||||0.1289
70934419|NCT02609048|141369719|SUPERIORITY||Difference in LSM|-4.56|STANDARD_ERROR_OF_MEAN|12.401||0.7155|TWO_SIDED|95.0|-29.85|20.73||Difference between means, p-value,and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as a factor, baseline GGT assessment as covariate,and percent change from baseline in GGT as response variable.|ANCOVA|||||20.73|-29.85|0.7155
71056957|NCT00591773|141618627|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.72|||<|0.001|TWO_SIDED|95.0|1.9|7.27||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||7.27|1.90|<0.001
71056958|NCT00591773|141618627|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.7||||0.002|TWO_SIDED|95.0|1.46|5.0||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||5.00|1.46|0.002
70934420|NCT02609048|141369720|SUPERIORITY||Difference in LSM|-34.27|STANDARD_ERROR_OF_MEAN|11.342||0.005|TWO_SIDED|95.0|-57.4|-11.14||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as a factor, baseline 5NT assessment as covariate,and percent change from baseline in 5NT as response variable.|ANCOVA|||||-11.14|-57.40|0.0050
71056959|NCT00591773|141618628|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0|||<|0.001|TWO_SIDED|95.0|2.41|6.64||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||6.64|2.41|<0.001
71056960|NCT00591773|141618628|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.96|||<|0.001|TWO_SIDED|95.0|1.83|4.79||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||4.79|1.83|<0.001
71056961|NCT00459355|141618629|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||MANCOVA|||||||<0.0001
71023818|NCT02151461|141554962|OTHER|Plasma Insulin Absolute AUC(0-2hr) (h\*uIU/mL)||||||0.3143|||||||ANCOVA|Total daily dose is twice the respective dose. Pairwise comparison using Treatment D as the reference group.||||||0.3143
71023819|NCT02151461|141554962|OTHER|Plasma Insulin Absolute AUC(0-2hr) (h\*uIU/mL)||||||0.5677|||||||ANCOVA|||||||0.5677
71023820|NCT02151461|141554962|OTHER|Plasma Insulin Absolute AUC(0-2hr) (h\*uIU/mL)||||||0.8407|||||||ANCOVA|||||||0.8407
71023821|NCT02151461|141554963|OTHER|||||||0.9789|||||||ANCOVA|Total daily dose is twice the respective dose Pairwise comparison using Treatment D as the reference group||||||0.9789
71023822|NCT02151461|141554963|OTHER|||||||0.841|||||||ANCOVA|||||||0.841
71023823|NCT02151461|141554963|OTHER|||||||0.748|||||||ANCOVA|||||||0.748
71023824|NCT01365845|141554972|SUPERIORITY_OR_OTHER||Non-parametric paired t-test (Wilcoxon)|29.1||||0.0078|||||||Wilcoxon (Mann-Whitney)|||||||0.0078
71023825|NCT03210259|141554977|EQUIVALENCE|Equivalence was concluded if the confidence interval (CI) for the least squares (LS) means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Least squares means ratio|105.19|||||TWO_SIDED|90.2|96.58|114.64|||||The least squares means were from ANCOVA. Ratio was calculated with the switching arm in the numerator and the continuous arm in the denominator.|The null hypothesis was that the ratio of expected means for Switching vs. Continuous Humira is less than 80.00% or more than 125.00%.||114.64|96.58|
71023826|NCT03210259|141554978|EQUIVALENCE|Equivalence was concluded if the confidence interval (CI) for the LS means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Least squares means ratio|101.14|||||TWO_SIDED|90.2|93.26|109.7|||||The least squares means were from ANCOVA. Ratio was calculated with the switching arm in the numerator and the continuous arm in the denominator.|The null hypothesis was that the ratio of expected means for Switching vs. Continuous Humira is less than 80.00% or more than 125.00%.||109.70|93.26|
71023827|NCT03210259|141554979|OTHER||Least squares means ratio|107.31|||||TWO_SIDED|90.2|97.33|118.43|||||The least squares means were from ANCOVA. Ratio was calculated with the switching arm as numerator and the continuous arm as the denominator.|No hypothesis was defined and no statistical test was performed.||118.43|97.33|
71023828|NCT03210259|141554981|OTHER||Risk Difference (RD)|5.75|||||TWO_SIDED|90.0|-2.45|13.96|||||Risk difference was calculated as Switching arm minus Continuous Humira.|No hypothesis was tested.||13.96|-2.45|
71023829|NCT03210259|141554982|OTHER||Risk Difference (RD)|5.63|||||TWO_SIDED|90.0|-4.35|15.62|||||Risk difference was calculated as Switching arm minus Continuous Humira.|No hypothesis was tested.||15.62|-4.35|
71056962|NCT00459355|141618630|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||MANCOVA|||||||<.0001
71056963|NCT00459355|141618631|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||MANCOVA|||||||.002
71056964|NCT02135614|141618648|SUPERIORITY||Treatment difference|0.12||||0.46|TWO_SIDED|95.0|-0.2|0.43||P-value was calculated from the ANCOVA model including baseline values, Clinical Frailty Scale (CFS) score, and stratification factor as covariates.|ANCOVA|||||0.43|-0.20|0.46
71056965|NCT02135614|141618649|SUPERIORITY||Treatment difference|0.08||||0.046|TWO_SIDED|95.0|0.0|0.16||P-value was calculated from the ANCOVA model including the baseline value, CFS score and stratification factor as covariates.|ANCOVA|||||0.16|0.00|0.046
71056966|NCT02135614|141618650|SUPERIORITY|||||||0.39||||||P-value was calculated from the negative binomial model with the stratification factor as covariate.|Negative Binomial Model|||||||0.39
71056967|NCT02135614|141618651|SUPERIORITY|||||||0.004||||||P-value from the negative binomial model comparing the rate ratio between treatment groups, adjusted for the stratification factor.|Negative Binomial Model|||||||0.004
71056968|NCT02462291|141618652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.27||||1|TWO_SIDED|95.0|-7.9|5.4|||ANOVA|||Baseline||5.4|-7.9|1
71056969|NCT02462291|141618652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.3|||<|0.01|TWO_SIDED|95.0|26.4|40.2|||ANOVA|||After the treatment||40.2|26.4|<0.01
71056970|NCT02462291|141618652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.5|||<|0.01|TWO_SIDED|95.0|-38.2|-24.8|||ANOVA|||PRE Vs POST||-24.8|-38.2|<0.01
71056971|NCT02462291|141618652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1||||1|TWO_SIDED|95.0|-3.7|9.9|||ANOVA|||PRE Vs POST||9.9|-3.7|1
71056972|NCT02462291|141618653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||1|TWO_SIDED|95.0|-0.8|0.5|||ANOVA|||Baseline||0.5|-0.8|1
70934421|NCT02609048|141369720|SUPERIORITY||Difference in LSM|-24.84|STANDARD_ERROR_OF_MEAN|10.116||0.0199|TWO_SIDED|95.0|-45.47|-4.21||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as a factor, baseline 5NT assessment as covariate,and percent change from baseline in 5NT as response variable.|ANCOVA|||||-4.21|-45.47|0.0199
70934422|NCT02609048|141369720|SUPERIORITY||Difference in LSM|-9.43|STANDARD_ERROR_OF_MEAN|11.442||0.4161|TWO_SIDED|95.0|-32.77|13.9||Difference between means,p-value, and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as a factor, baseline 5NT assessment as covariate,and percent change from baseline in 5NT as response variable.|ANCOVA|||||13.90|-32.77|0.4161
70934423|NCT02609048|141369721|SUPERIORITY||Difference in LSM|6.2|STANDARD_ERROR_OF_MEAN|8.626||0.478|TWO_SIDED|95.0|-11.4|23.79||Difference between means,p-value, and CIs estimated by comparing each Seladelpar level with placebo by ANCOVA model.Treatment group as factor, baseline assessment as covariate, and percent change from baseline in total bilirubin as response variable.|ANCOVA|||||23.79|-11.40|0.4780
70934424|NCT02609048|141369721|SUPERIORITY||Difference in LSM|-12.0|STANDARD_ERROR_OF_MEAN|8.043||0.1459|TWO_SIDED|95.0|-28.4|4.41||Difference between means,p-value, and CIs estimated by comparing each Seladelpar level with placebo by ANCOVA model.Treatment group as factor, baseline assessment as covariate, and percent change from baseline in total bilirubin as response variable.|ANCOVA|||||4.41|-28.40|0.1459
70934425|NCT02609048|141369721|SUPERIORITY||Difference in LSM|18.19|STANDARD_ERROR_OF_MEAN|8.521||0.0407|TWO_SIDED|95.0|0.82|35.57||Difference between means,p-value, and CIs estimated by comparing Seladelpar 200 mg versus 50 mg by ANCOVA model.Treatment group as factor, baseline assessment as covariate, and percent change from baseline in total bilirubin as response variable.|ANCOVA|||||35.57|0.82|0.0407
70934426|NCT02609048|141369722|SUPERIORITY||Difference in LSM|31.47|STANDARD_ERROR_OF_MEAN|13.831||0.03|TWO_SIDED|95.0|3.26|59.67||Difference between means,p-value,and CIs are estimated by each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline assessment as covariate,and percent change from baseline in conjugated bilirubin as response variable.|ANCOVA|||||59.67|3.26|0.0300
70934427|NCT02609048|141369722|SUPERIORITY||Difference in LSM|-8.84|STANDARD_ERROR_OF_MEAN|12.883||0.4979|TWO_SIDED|95.0|-35.11|17.44||Difference between means,p-value,and CIs are estimated by each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline assessment as covariate,and percent change from baseline in conjugated bilirubin as response variable.|ANCOVA|||||17.44|-35.11|0.4979
70934428|NCT02609048|141369722|SUPERIORITY||Difference in LSM|40.3|STANDARD_ERROR_OF_MEAN|13.591||0.0058|TWO_SIDED|95.0|12.58|68.02||Difference between means,p-value,and CIs are estimated for Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline assessment as covariate,and percent change from baseline in conjugated bilirubin as response variable.|ANCOVA|||||68.02|12.58|0.0058
71056973|NCT02462291|141618653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.94|||<|0.01|TWO_SIDED|95.0|-2.6|-1.2|||ANOVA|||After the treatment||-1.2|-2.6|<0.01
71056974|NCT02462291|141618653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94|||<|0.01|TWO_SIDED|95.0|0.28|1.61|||ANOVA|||PRE Vs POST||1.61|0.28|<0.01
71056975|NCT02462291|141618653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|||<|0.01|TWO_SIDED|95.0|-1.52|-0.17|||ANOVA|||PRE Vs POST||-0.17|-1.52|<0.01
71108001|NCT02949011|141721544|SUPERIORITY|||||||0.0708||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||216 hours||||0.0708
70934429|NCT02609048|141369723|SUPERIORITY||Difference in LSM|-2.97|STANDARD_ERROR_OF_MEAN|8.362||0.7244|TWO_SIDED|95.0|-20.03|14.08||Difference between means,p-value, and CIs are estimated by comparing Seladelpar level with placebo using ANCOVA model.Treatment group as a factor,baseline assessment as covariate, and percent change from baseline as the response variable.|ANCOVA|||||14.08|-20.03|0.7244
70934430|NCT02609048|141369723|SUPERIORITY||Difference in LSM|-14.15|STANDARD_ERROR_OF_MEAN|7.819||0.08|TWO_SIDED|95.0|-30.1|1.8||Difference between means,p-value, and CIs are estimated by comparing Seladelpar level with placebo using ANCOVA model.Treatment group as a factor,baseline assessment as covariate, and percent change from baseline as the response variable.|ANCOVA|||||1.80|-30.10|0.0800
70934431|NCT02609048|141369723|SUPERIORITY||Difference in LSM|11.18|STANDARD_ERROR_OF_MEAN|8.29||0.1874|TWO_SIDED|95.0|-5.73|28.08||Difference between means,p-value, and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as a factor,baseline assessment as covariate, and percent change from baseline as the response variable.|ANCOVA|||||28.08|-5.73|0.1874
70934432|NCT02609048|141369724|SUPERIORITY||Difference in LSM|-45.96|STANDARD_ERROR_OF_MEAN|6.638|<|0.0001|TWO_SIDED|95.0|-59.5|-32.42||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline bone-specific AP assessment as covariate,and percent change from baseline as response variable.|ANCOVA|||||-32.42|-59.50|<0.0001
71056976|NCT02462291|141618654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|||=|0.84|TWO_SIDED|95.0|-3.6|2.1|||ANOVA|||Baseline||2.1|-3.6|= 0.84
71056977|NCT02462291|141618654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31|||=|0.9|TWO_SIDED|95.0|-4.3|1.7|||ANOVA|||After the treatment||1.7|-4.3|= 0.9
71056978|NCT02462291|141618654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.88|TWO_SIDED|95.0|-3.14|2.69|||ANOVA|||PRE Vs POST||2.69|-3.14|0.88
71056979|NCT02462291|141618654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.89|TWO_SIDED|95.0|-3.73|2.16|||ANOVA|||PRE Vs POST||2.16|-3.73|0.89
71056980|NCT02462291|141618655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.37||||0.9|TWO_SIDED|95.0|-5.48|2.73|||ANOVA|||Baseline||2.73|-5.48|0.9
71056981|NCT02462291|141618655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.62||||0.59|TWO_SIDED|95.0|-1.6|6.9|||ANOVA|||After the treatment||6.90|-1.60|0.59
71056982|NCT02462291|141618655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.99||||0.34|TWO_SIDED|95.0|-7.15|1.16|||ANOVA|||PRE Vs POST||1.16|-7.15|0.34
71108002|NCT02949011|141721544|SUPERIORITY|||||||0.4024||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||216 hours||||0.4024
71056983|NCT02462291|141618655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03||||0.9|TWO_SIDED|95.0|-3.17|5.23|||ANOVA|||PRE Vs POST||5.23|-3.17|0.9
71056984|NCT02462291|141618656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.36||||0.83|TWO_SIDED|95.0|-1.41|2.14|||ANOVA|||Baseline||2.14|-1.41|0.83
71056985|NCT02462291|141618656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.69|||<|0.01|TWO_SIDED|95.0|0.84|4.53|||ANOVA|||After the treatment||4.53|0.84|<0.01
71056986|NCT02462291|141618656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.14||||0.01|TWO_SIDED|95.0|-3.94|-0.34|||ANOVA|||PRE Vs POST||-0.34|-3.94|0.010
71056987|NCT02462291|141618656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.84|TWO_SIDED|95.0|-1.64|2.0|||ANOVA|||PRE Vs POST||2.00|-1.64|0.84
71056988|NCT02462291|141618657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39||||0.11|TWO_SIDED|95.0|-0.16|2.95|||ANOVA|||Baseline||2.95|-0.16|0.11
71056989|NCT02462291|141618657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79||||0.7|TWO_SIDED|95.0|-0.81|2.41|||ANOVA|||After the treatment||2.41|-0.81|0.7
71056990|NCT02462291|141618657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.88|TWO_SIDED|95.0|-1.17|1.98|||ANOVA|||PRE Vs POST||1.98|-1.17|0.88
71056991|NCT02462291|141618657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.95|TWO_SIDED|95.0|-1.78|1.39|||ANOVA|||PRE Vs POST||1.39|-1.78|0.95
71056992|NCT02462291|141618658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.95|TWO_SIDED|95.0|-0.67|0.4|||ANOVA|||Baseline||0.40|-0.67|0.95
71056993|NCT02462291|141618658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43||||0.23|TWO_SIDED|95.0|-0.12|0.99|||ANOVA|||After the treatment||0.99|-0.12|0.23
71056994|NCT02462291|141618658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.96|TWO_SIDED|95.0|-0.65|0.44|||ANOVA|||PRE Vs POST||0.44|-0.65|0.96
71056995|NCT02462291|141618658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46||||0.15|TWO_SIDED|95.0|-0.08|1.01|||ANOVA|||PRE Vs POST||1.01|-0.08|0.15
71056996|NCT02462291|141618659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.84|TWO_SIDED|95.0|-1.14|1.27|||ANOVA|||Baseline||1.27|-1.14|0.84
71056997|NCT02462291|141618659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.81|TWO_SIDED|95.0|-0.96|1.54|||ANOVA|||After the treatment||1.54|-0.96|0.81
71056998|NCT02462291|141618659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.86|TWO_SIDED|95.0|-1.71|0.74|||ANOVA|||PRE Vs POST||0.74|-1.71|0.86
71056999|NCT02462291|141618659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.75|TWO_SIDED|95.0|-1.49|0.97|||ANOVA|||PRE Vs POST||0.97|-1.49|0.75
71057000|NCT02462291|141618660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.7||||0.94|TWO_SIDED|95.0|-74.4|44.9|||ANOVA|||Baseline||44.9|-74.4|0.94
71057001|NCT02462291|141618660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.36||||0.87|TWO_SIDED|95.0|-53.47|70.2|||ANOVA|||After the treatment||70.20|-53.47|0.87
71108003|NCT02949011|141721545|SUPERIORITY||Median Difference|-25.8|||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||<0.0001
71108004|NCT02949011|141721545|SUPERIORITY||Median Difference|-8.6||||0.9127||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.9127
70941677|NCT04748445|141383934|OTHER||Slope|-0.002892|STANDARD_ERROR_OF_MEAN|1.205||0.8107|TWO_SIDED|90.0|-0.02286|0.01707|||Mixed Models Analysis|||MM\_MFCC std 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.01707|-0.02286|0.8107
71057002|NCT02462291|141618660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.7||||0.78|TWO_SIDED|95.0|-90.19|30.78|||ANOVA|||PRE Vs POST||30.78|-90.19|0.78
71057003|NCT02462291|141618660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6||||0.84|TWO_SIDED|95.0|-67.7|54.5|||ANOVA|||PRE Vs POST||54.5|-67.7|0.84
71057004|NCT02462291|141618661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.74|TWO_SIDED|95.0|-3.73|4.56|||ANOVA|||Baseline||4.56|-3.73|0.74
71057005|NCT02462291|141618661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25||||0.82|TWO_SIDED|95.0|-5.54|3.04|||ANOVA|||After the treatment||3.04|-5.54|0.82
71057006|NCT02462291|141618661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.59|TWO_SIDED|95.0|-3.57|4.82|||ANOVA|||PRE Vs POST||4.82|-3.57|0.59
71057007|NCT02462291|141618661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04||||0.69|TWO_SIDED|95.0|-5.28|3.19|||ANOVA|||PRE Vs POST||3.19|-5.28|0.69
71057008|NCT02462291|141618662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.9|TWO_SIDED|95.0|-0.64|1.09|||ANOVA|||Baseline||1.09|-0.64|0.9
71057009|NCT02462291|141618662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.86|||<|0.01|TWO_SIDED|95.0|1.96|3.76|||ANOVA|||After the treatment||3.76|1.96|<0.01
71057010|NCT02462291|141618662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.92|||<|0.01|TWO_SIDED|95.0|-3.8|-2.04|||ANOVA|||PRE Vs POST||-2.04|-3.80|<0.01
71057011|NCT02462291|141618662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.88|TWO_SIDED|95.0|-1.17|0.59|||ANOVA|||PRE Vs POST||0.59|-1.17|0.88
71057012|NCT02462291|141618663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.83|TWO_SIDED|95.0|-0.72|0.37|||ANOVA|||Baseline||0.37|-0.72|0.83
71057013|NCT02462291|141618663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72||||0.005|TWO_SIDED|95.0|0.15|1.29|||ANOVA|||After the treatment||1.29|0.15|0.005
71057014|NCT02462291|141618663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.013|TWO_SIDED|95.0|-1.21|-0.09|||ANOVA|||PRE Vs POST||-0.09|-1.21|0.013
71057015|NCT02462291|141618663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.87|TWO_SIDED|95.0|-0.31|0.81|||ANOVA|||PRE Vs POST||0.81|-0.31|0.87
71057016|NCT02462291|141618664|SUPERIORITY_OR_OTHER||Chi-squared value|0.542|||=|0.91|TWO_SIDED||||||Chi-squared||Power of performed test with alpha = 0.050: 0.082; 3 degrees of freedom|||||= 0.910
71057017|NCT02462291|141618665|SUPERIORITY_OR_OTHER||Chi-squared value|17.73|||<|0.001|TWO_SIDED||||||Chi-squared||Power of performed test with alpha = 0.050: 0.965; 3 degrees of freedom|||||<0.001
71057018|NCT02462291|141618666|SUPERIORITY_OR_OTHER||Chi-squared value|5.749||||0.124|TWO_SIDED||||||Chi-squared||Power of performed test with alpha = 0.050: 0.488; 3 degrees of freedom|||||0.124
70934433|NCT02609048|141369724|SUPERIORITY||Difference in LSM|-34.66|STANDARD_ERROR_OF_MEAN|6.46|<|0.0001|TWO_SIDED|95.0|-47.83|-21.48||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline bone-specific AP assessment as covariate,and percent change from baseline as response variable.|ANCOVA|||||-21.48|-47.83|<0.0001
70934434|NCT02609048|141369724|SUPERIORITY||Difference in LSM|-11.3|STANDARD_ERROR_OF_MEAN|6.508||0.0924|TWO_SIDED|95.0|-24.58|1.97||Difference between means,p-value,and CIs are estimated comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline bone-specific AP assessment as covariate,and percent change from baseline as response variable.|ANCOVA|||||1.97|-24.58|0.0924
70934435|NCT02609048|141369725|SUPERIORITY||Difference in LSM|-14.15|STANDARD_ERROR_OF_MEAN|12.807||0.2777|TWO_SIDED|95.0|-40.27|11.97||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline TG assessment as a covariate, and percent change from baseline in TG as response variable.|ANCOVA|||||11.97|-40.27|0.2777
70934436|NCT02609048|141369725|SUPERIORITY||Difference in LSM|-37.31|STANDARD_ERROR_OF_MEAN|11.946||0.0039|TWO_SIDED|95.0|-61.67|-12.95||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline TG assessment as a covariate, and percent change from baseline in TG as response variable.|ANCOVA|||||-12.95|-61.67|0.0039
70934437|NCT02609048|141369725|SUPERIORITY||Difference in LSM|23.16|STANDARD_ERROR_OF_MEAN|12.498||0.0734|TWO_SIDED|95.0|-2.33|48.65||Difference between means,p-value, and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor, baseline TG assessment as a covariate, and percent change from baseline in TG as response variable.|ANCOVA|||||48.65|-2.33|0.0734
70934438|NCT02609048|141369726|SUPERIORITY||Difference in LSM|-16.12|STANDARD_ERROR_OF_MEAN|4.433||0.001|TWO_SIDED|95.0|-25.16|-7.07||Difference between means,p-value,and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline TC assessment as covariate,and percent change from baseline in TC as the response variable.|ANCOVA|||||-7.07|-25.16|0.0010
70934439|NCT02609048|141369726|SUPERIORITY||Difference in LSM|-8.13|STANDARD_ERROR_OF_MEAN|3.992||0.0504|TWO_SIDED|95.0|-16.27|0.02||Difference between means,p-value,and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline TC assessment as covariate,and percent change from baseline in TC as the response variable.|ANCOVA|||||0.02|-16.27|0.0504
70934440|NCT02609048|141369726|SUPERIORITY||Difference in LSM|-7.99|STANDARD_ERROR_OF_MEAN|4.317||0.0738|TWO_SIDED|95.0|-16.8|0.81||Difference between means,p-value,and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor, baseline TC assessment as covariate,and percent change from baseline in TC as the response variable.|ANCOVA|||||0.81|-16.80|0.0738
70934441|NCT02609048|141369727|SUPERIORITY||Difference in LSM|-17.39|STANDARD_ERROR_OF_MEAN|5.848||0.0057|TWO_SIDED|95.0|-29.32|-5.46||Difference between means,p-value,and CIs estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline HDL-C assessment as covariate,and percent change from baseline in HDL-C as response variable.|ANCOVA|||||-5.46|-29.32|0.0057
71057019|NCT02462291|141618667|SUPERIORITY_OR_OTHER||Chi-squared value|0.008||||1|TWO_SIDED||||||Chi-squared||Power of performed test with alpha = 0.050: 0.050; 3 degrees of freedom|||||1
70934442|NCT02609048|141369727|SUPERIORITY||Difference in LSM|-0.89|STANDARD_ERROR_OF_MEAN|5.378||0.8703|TWO_SIDED|95.0|-11.85|10.08||Difference between means,p-value,and CIs estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline HDL-C assessment as covariate,and percent change from baseline in HDL-C as response variable.|ANCOVA|||||10.08|-11.85|0.8703
70934443|NCT02609048|141369727|SUPERIORITY||Difference in LSM|-16.51|STANDARD_ERROR_OF_MEAN|5.781||0.0076|TWO_SIDED|95.0|-28.3|-4.71||Difference between means,p-value,and CIs estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline HDL-C assessment as covariate,and percent change from baseline in HDL-C as response variable.|ANCOVA|||||-4.71|-28.30|0.0076
70934444|NCT02609048|141369728|SUPERIORITY||Difference in LSM|-14.85|STANDARD_ERROR_OF_MEAN|5.981||0.0186|TWO_SIDED|95.0|-27.05|-2.66||Difference between means,p-value, and CIs estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline LDL-C assessment as covariate,and percent change from baseline in LDL-C as response variable.|ANCOVA|||||-2.66|-27.05|0.0186
70934445|NCT02609048|141369728|SUPERIORITY||Difference in LSM|-10.06|STANDARD_ERROR_OF_MEAN|5.448||0.0745|TWO_SIDED|95.0|-21.17|1.06||Difference between means,p-value, and CIs estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline LDL-C assessment as covariate,and percent change from baseline in LDL-C as response variable.|ANCOVA|||||1.06|-21.17|0.0745
70934446|NCT02609048|141369728|SUPERIORITY||Difference in LSM|-4.8|STANDARD_ERROR_OF_MEAN|5.785||0.4131|TWO_SIDED|95.0|-16.6|7.0||Difference between means,p-value, and CIs estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline LDL-C assessment as covariate,and percent change from baseline in LDL-C as response variable.|ANCOVA|||||7.00|-16.60|0.4131
70934447|NCT02609048|141369729|SUPERIORITY|||||||0.4667||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.4667
70934448|NCT02609048|141369729|SUPERIORITY|||||||0.4667||||||Fisher's exact test between Seladelpar 200 mg versus 50 mg was used to obtain the p-value.|Fisher Exact|||||||0.4667
70934449|NCT02609048|141369730|SUPERIORITY|||||||0.0824||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.0824
70934450|NCT02609048|141369730|SUPERIORITY|||||||0.0537||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.0537
70934451|NCT02609048|141369730|SUPERIORITY|||||||1||||||Fisher's exact test between Seladelpar 200 mg versus 50 mg was used to obtain the p-value.|Fisher Exact|||||||1.0000
71057020|NCT02462291|141618668|SUPERIORITY_OR_OTHER||Chi-squared value|1.049||||0.789|TWO_SIDED||||||Chi-squared||Power of performed test with alpha = 0.050: 0.116; 3 degrees of freedom|||||0.789
71057021|NCT03106987|141618675|OTHER||Hazard Ratio (HR)|0.566||||0.022|TWO_SIDED|95.0|0.372|0.868|||Stratified log-rank||Hazard Ratio (Cox Proportional Hazards model)|||0.868|0.372|0.0220
71057022|NCT03106987|141618675|OTHER||Hazard Ratio (HR)|0.43||||0.0023|TWO_SIDED|95.0|0.264|0.708|||Stratified log-rank||Hazard Ratio (Cox Proportional Hazards model)|||0.708|0.264|0.0023
71023830|NCT02110706|141554988|OTHER|"A futility (non-superiority) design is a screening tool to identify whether agents should be candidates for phase III trials while minimizing costs/sample size If futility is declared, results would imply not cost effective to conduct a future phase III clinical trial If futility is not declared, suggests that there could be a clinically meaningful effect - supports exploration in a larger, phase III trial"|Odds Ratio (OR)|1.14||||0.03|ONE_SIDED|90.0||2.41|||Regression, Logistic|||"This futility design tests the following hypothesis:~H0: Rituximab improves outcome by at least 30% compared to placebo (pR - pP ≥ 0.30 - not futile) versus HA: Rituximab does not improve outcome by at least 30% compared to placebo (pR - pP \< 0.30 - futile)"||2.41||0.03
71023831|NCT02110706|141554989|SUPERIORITY||Odds Ratio (OR)|0.72||||0.63|TWO_SIDED|90.0|0.23|2.21|||t-test, 2 sided|||% of study participants with treatment related AEs||2.21|0.23|0.63
71023832|NCT02110706|141554989|SUPERIORITY||Odds Ratio (OR)|0.75||||0.65|TWO_SIDED|90.0|0.27|2.11|||t-test, 2 sided|||% study participants with treatment related SAEs||2.11|0.27|0.65
71057023|NCT02114385|141618684|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.50|GMT Ratio|1.23|||<|0.001|TWO_SIDED|95.0|1.04|1.45|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 6||1.45|1.04|<0.001
70851710|NCT01818752|141191318|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.179||||0.1388|TWO_SIDED|95.0|0.875|1.589||Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.|Stratified Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Chi-square test stratified by ISS stage, choice of route of bortezomib administration, region and age.|Odds ratio (Carfilzomib/Bortezomib) was estimated using the Mantel-Haenszel method stratified by ISS stage, choice of route of bortezomib administration, region and age.|||1.589|0.875|0.1388
71023833|NCT02110706|141554990|OTHER||Mean Difference (Final Values)|-0.11||||0.93|ONE_SIDED|90.0||2.02|||Regression, Linear|||This objective was assessed longitudinally by comparing the final score at the end of the study to the score obtained at baseline. The outcome was defined as the change from baseline to week 52 in the MGC. This hypothesis was assessed using a linear regression model, adjusted for differences in baseline MGC scores.||2.02||0.93
71057024|NCT02114385|141618684|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.50|GMT Ratio|0.89|||<|0.001|TWO_SIDED|95.0|0.76|1.04|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 11||1.04|0.76|<0.001
70851711|NCT01818752|141191319|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.048|||<|0.0001|TWO_SIDED|95.0|0.026|0.088||Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.|Pearson Chi-Square test||Unstratified odds ratio (Carfilzomib/Bortezomib) was estimated.|||0.088|0.026|< 0.0001
70934452|NCT02609048|141369731|SUPERIORITY|||||||0.0101||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.0101
71023834|NCT02110706|141554991|OTHER||Mean Difference (Final Values)|-1.09||||0.39|ONE_SIDED|90.0||1.03|||Regression, Linear|||This objective was assessed longitudinally by comparing the final score at the end of the study to the score obtained at baseline. The outcome was defined as the change from baseline to week 52 in the QMG. This hypothesis was assessed using a linear regression model, adjusted for differences in baseline QMG scores.||1.03||0.39
71023835|NCT00252187|141554997|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared|||Change in end systolic LV volume index compared between two groups||||0.004
71057025|NCT02114385|141618684|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.50|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.89|1.21|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 16||1.21|0.89|<0.001
71057026|NCT02114385|141618684|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.50|GMT Ratio|1.12|||<|0.001|TWO_SIDED|95.0|0.91|1.37|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 18||1.37|0.91|<0.001
71057027|NCT04315506|141618705|SUPERIORITY||Odds Ratio (OR)|1.14||||0.5384|TWO_SIDED|95.0|0.75|1.72||The analysis was a two-intervention arm comparison. Adjustments for multiple tests and outcomes were not required.|Regression, Logistic||Odds of quitting in Enuf Snuff group (SGR) compared to Enough Snuff (control)|||1.72|0.75|0.5384
71057028|NCT04315506|141618706|SUPERIORITY||Slope|-0.1057||||0.6624|TWO_SIDED|95.0|-0.5808|0.3693||P-value above is for the treatment-by-time squared term in the statistical model for longitudinal data; quadratic change in outcome determined, compared trajectory of outcome change in EnufSnuff (SGR) compared to Enough Snuff (control)|Mixed Models Analysis|Multi-level, mixed-effects model for longitudinal data was conducted.|Slope difference estimate reported above, estimate compares trajectory slope coefficient for EnufSnuff (SGR) to slope coefficient for Enough Snuff (control).|For secondary outcomes, the study was not powered. The null hypothesis was no between-treatment arm difference in the trajectory of change from baseline to six months.||0.3693|-0.5808|0.6624
70934453|NCT02609048|141369731|SUPERIORITY|||||||0.0198||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.0198
70934454|NCT02609048|141369731|SUPERIORITY|||||||0.5165||||||Fisher's exact test between Seladelpar 200 mg versus 50 mg was used to obtain the p-value.|Fisher Exact|||||||0.5165
71023836|NCT00252187|141554997|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||Change in LV end diastolic volume was compared between two groups||||0.001
70934455|NCT02609048|141369732|SUPERIORITY|||||||0.0101||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.0101
71023837|NCT00252187|141554998|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||||||0.001
71023838|NCT00252187|141555000|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Chi-squared|||||||0.14
71023839|NCT00252187|141555001|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Chi-squared|||||||0.006
71023840|NCT03764059|141555005|NON_INFERIORITY|The test for non-inferiority is based on a 95% CI of the difference between the investigational and control groups with respect to the rate of clinically acceptable restorations at 1-year post placement. The non-inferiority margin was 7%. To establish non-inferiority the lower limit has to be \> -7%|Risk Difference (RD)|4.2|||<|0.0001|TWO_SIDED|95.0||9.2|||Cochran-Mantel-Haenszel|||||9.2|- 0.6|< 0.0001
71023841|NCT01261325|141555030|SUPERIORITY_OR_OTHER_LEGACY||Percent reduction over PBO|22.8|||<|0.001|TWO_SIDED|95.0|13.3|31.2||"Type I error rate of 0.05 based on a Hochberg multiple comparison procedure would be considered statistically significant or similar, as accurate and appropriate."|ANCOVA|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.||||31.2|13.3|<0.001
71023842|NCT01261325|141555030|SUPERIORITY_OR_OTHER_LEGACY||Percent reduction over PBO|23.2|||<|0.001|TWO_SIDED|95.0|13.8|31.6||Statistically significant with control of Type I error rate based on a Hochberg multiple comparison procedure.|ANCOVA|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.||||31.6|13.8|<0.001
71023843|NCT01261325|141555031|SUPERIORITY_OR_OTHER_LEGACY||Odds ratio (BRV versus PBO)|2.39|||<|0.001|TWO_SIDED|95.0|1.6|3.6||Statistically significant with control of Type I error rate based on a Hochberg multiple comparison procedure.|Regression, Logistic|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.||||3.6|1.6|<0.001
71023844|NCT01261325|141555031|SUPERIORITY_OR_OTHER_LEGACY||Odds ratio (BRV versus PBO)|2.19|||<|0.001|TWO_SIDED|95.0|1.5|3.3||Statistically significant with control of Type I error rate based on a Hochberg multiple comparison procedure.|Regression, Logistic|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.||||3.3|1.5|<0.001
71023845|NCT01261325|141555032|SUPERIORITY_OR_OTHER_LEGACY||Median difference vs placebo|15.8|||<|0.001|TWO_SIDED|95.0|7.6|24.2||Statistically significant at a nominal 0.050 significance level.|Wilcoxon (Mann-Whitney)||Hodges-Lehmann non-parametric effect estimates and corresponding two-sided 95% confidence intervals are provided above.|||24.2|7.6|<0.001
71023846|NCT01261325|141555032|SUPERIORITY_OR_OTHER_LEGACY||Median difference vs placebo|18.1|||<|0.001|TWO_SIDED|95.0|10.4|26.4||Statistically significant at a nominal 0.050 significance level.|Wilcoxon (Mann-Whitney)||Hodges-Lehmann non-parametric effect estimates and corresponding two-sided 95% confidence intervals are provided above.|||26.4|10.4|<0.001
71023847|NCT01261325|141555036|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.67|||<|0.001|TWO_SIDED|95.0|0.56|0.82||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.|Hazard ratio is Brivaracetam versus Placebo.|||0.82|0.56|<0.001
71023848|NCT01261325|141555036|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.65|||<|0.001|TWO_SIDED|95.0|0.54|0.79||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.|Hazard ratio is Brivaracetam versus Placebo.|||0.79|0.54|<0.001
71077940|NCT02913105|141664399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.97||||0.6035|TWO_SIDED|90.0|0.9|1.06|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 28||1.06|0.90|0.6035
71023849|NCT01261325|141555037|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.65|||<|0.001|TWO_SIDED|95.0|0.53|0.8||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.|Hazard ratio is Brivaracetam versus Placebo.|||0.80|0.53|<0.001
71023850|NCT01261325|141555037|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.47|0.71||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.|Hazard ratio is Brivaracetam versus Placebo.|||0.71|0.47|<0.001
71023851|NCT01261325|141555038|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.009|TWO_SIDED|95.0|0.6|0.93||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.||||0.93|0.60|0.009
71023852|NCT01261325|141555038|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.68|||<|0.001|TWO_SIDED|95.0|0.55|0.85||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.||||0.85|0.55|<0.001
71023853|NCT00990561|141555044|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.0|||<|0.001|TWO_SIDED|95.0|||||t-test, 2 sided|||Null hypothesis = there is no difference between using ultravate once daily vs. twice daily||||<0.001
70934456|NCT02609048|141369732|SUPERIORITY|||||||0.0055||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.0055
71023854|NCT03404206|141555045|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
71023855|NCT03404206|141555045|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
70934457|NCT02609048|141369732|SUPERIORITY|||||||1||||||Fisher's exact test between Seladelpar 200 mg versus 50 mg was used to obtain the p-value.|Fisher Exact|||||||1.0000
71023856|NCT03404206|141555046|SUPERIORITY||Least squares means|-34.73|||||TWO_SIDED|95.0|-45.67|-23.8|||ANCOVA|||||-23.8|-45.67|
71023857|NCT03404206|141555046|SUPERIORITY||Least squares means|-73.43|||||TWO_SIDED|95.0|-89.01|-57.85|||ANCOVA|||||-57.85|-89.01|
71023858|NCT03404206|141555046|SUPERIORITY||Least squares means|-38.7|||||TWO_SIDED|95.0|-54.29|-23.11|||ANCOVA|||||-23.11|-54.29|
71023859|NCT03404206|141555047|SUPERIORITY||Least squares means|-18.21|||||TWO_SIDED|95.0|-23.52|-12.89|||ANCOVA|||||-12.89|-23.52|
71023860|NCT03404206|141555047|SUPERIORITY||Least squares means|-33.72|||||TWO_SIDED|95.0|-41.29|-26.14|||ANCOVA|||||-26.14|-41.29|
71023861|NCT03404206|141555047|SUPERIORITY||Least squares means|-15.51|||||TWO_SIDED|95.0|-23.09|-7.93|||ANCOVA|||||-7.93|-23.09|
71023862|NCT02330081|141555065|NON_INFERIORITY|The FDA validation level requirements for test platelet quality is that the lower 1-sided 95% confidence limit of platelet recovery must be ≥ 66% of fresh control platelet values|Risk Ratio (RR)|83.3|STANDARD_ERROR_OF_MEAN|4.97|||ONE_SIDED|95.0|76.2||||||Estimate is the ratio of the mean platelet recovery of treatment over control||||76.2|
71057029|NCT04315506|141618707|SUPERIORITY||Slope|0.0946||||0.232|TWO_SIDED|95.0|-0.0609|0.2501||A multi-level, mixed-effects model for longitudinal data was applied. The p-value provided above was for the treatment-by-time effect used to test for differences in the trajectory of change in craving reduction between the two treatment groups.|Mixed Models Analysis|Multi-level, mixed-effects model for longitudinal data was conducted. (trajectory analysis)|Slope difference estimate reported above, estimate compares trajectory slope coefficient for EnufSnuff (SGR) to slope coefficient for Enough Snuff (control).|For secondary outcomes, the study was not powered. The null hypothesis was no between-treatment arm difference in the trajectory of change from baseline to six months.||0.2501|-0.0609|0.2320
70934458|NCT02609048|141369734|SUPERIORITY||Difference in LSM|-1.1|STANDARD_ERROR_OF_MEAN|1.82||0.5379|TWO_SIDED|95.0|-4.8|2.6||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline score as covariate, and change from baseline score as the response variable.|ANCOVA|||||2.6|-4.8|0.5379
70934459|NCT02609048|141369734|SUPERIORITY||Difference in LSM|0.2|STANDARD_ERROR_OF_MEAN|1.7||0.8949|TWO_SIDED|95.0|-3.3|3.7||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline score as covariate, and change from baseline score as the response variable.|ANCOVA|||||3.7|-3.3|0.8949
71023863|NCT02330081|141555066|NON_INFERIORITY|One of the FDA validation level requirements for test platelet quality is that the lower 1-sided 95% confidence limit of the mean platelet survival time must be ≥58% of fresh control platelet mean survival time|Mean Ratio Survival Time|81.0|STANDARD_ERROR_OF_MEAN|2.0|||ONE_SIDED|95.0|77.0||||||Estimate is the ratio of the mean platelet survival time of treatment over control||||77.0|
71023864|NCT04549259|141555190|SUPERIORITY||Odds Ratio (OR)|3.23||||0.33|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.33
71023865|NCT04549259|141555190|SUPERIORITY||Odds Ratio (OR)|1.76||||0.63|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.63
71023866|NCT04549259|141555190|SUPERIORITY||Odds Ratio (OR)|0.68||||0.78|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.78
71023867|NCT04549259|141555190|SUPERIORITY||Odds Ratio (OR)|0.87||||0.9|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.90
71023868|NCT04549259|141555190|OTHER|Single group change over time.|Odds Ratio (OR)|2.89||||0.38|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.38
71057030|NCT03593395|141618711|OTHER|Estimation only|Least Square Mean Estimate|2.46|||||TWO_SIDED|95.0|1.81|3.34|||||Estimates are from generalized linear mixed model with a negative binomial distribution log link construct and length of follow up offset. Includes fixed effects for site size, baseline acute utilization, and random effect for cluster (site).|||3.34|1.81|
71057031|NCT03593395|141618711|OTHER|Estimation only.|Least Square Mean Estimate|2.96|||||TWO_SIDED|95.0|2.09|4.19|||||Estimates are from generalized linear mixed model with a negative binomial distribution log link construct and length of follow up offset. Includes fixed effects for site size, baseline acute utilization, and random effect for cluster (site).|||4.19|2.09|
71057032|NCT02995408|141618724|SUPERIORITY||Mean Difference (Final Values)|-0.99||||0.23|TWO_SIDED|95.0|-2.63|0.65||p-value was calculated|t-test, 2 sided|||||0.65|-2.63|.23
71057033|NCT02995408|141618725|SUPERIORITY||Mean Difference (Final Values)|5.78||||0.024|TWO_SIDED|95.0|0.78|10.78||.05 is the threshold for significance|t-test, 2 sided|||We examined between group (3RP treatment versus wait-list) differences in pre-post change scores of resiliency.||10.78|.78|0.024
71057034|NCT02995408|141618726|SUPERIORITY||Mean Difference (Final Values)|7.78||||0.001|TWO_SIDED|95.0|3.45|12.12||p=.05 is the threshold for significance.|t-test, 2 sided|||||12.12|3.45|0.001
71057035|NCT05084924|141618852|SUPERIORITY|||||||0.049|||||||ANOVA|Main effect of stimulation: F(2,32) = 3.32||||||0.049
71057036|NCT05084924|141618853|SUPERIORITY|||||||0.004||||||Main effect of stimulation: F(2,32) = 6.67|ANOVA|||||||0.004
71023869|NCT04549259|141555190|OTHER|Single group change over time.|Odds Ratio (OR)|1.25||||0.78|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.78
71023870|NCT04549259|141555190|OTHER|Single group change over time.|Odds Ratio (OR)|2.32||||0.45|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.45
71057037|NCT00704132|141618854|SUPERIORITY_OR_OTHER||Difference in Least-Squares Mean|-111.0|||<|0.001||95.0|-158.0|-63.9|||ANCOVA||Sitagliptin minus Placebo|||-63.9|-158.0|<0.001
71057038|NCT00182325|141618855|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71057039|NCT00182325|141618856|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
71057040|NCT00182325|141618857|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||0.68
71057041|NCT00182325|141618858|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
71057042|NCT00182325|141618859|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||||||0.57
71057043|NCT00182325|141618860|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
71057044|NCT00182325|141618861|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
71057045|NCT00182325|141618862|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||||||0.57
71057046|NCT00182325|141618863|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|||||||0.26
71057047|NCT00182325|141618864|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||||||0.12
71057048|NCT03417778|141618865|OTHER|If the upper bound of the 2-sided 90% CIs of the GLSM ratio for AUClast of filgotinib falls within the \[50%, 200%\] bound, the null hypothesis that participants with hepatic impairment exhibit AUClast change of at least 2-fold for filgotinib compared with participants with normal liver function will be rejected.|GLSM Ratio|161.14|||||TWO_SIDED|90.0|80.77|321.48||||||An analysis of variance (ANOVA) model was fitted to the natural logarithmic transformed values of the AUClast. Two-sided 90% confidence intervals (CI) were calculated for the geometric least-squares mean (GLSM) ratio of AUClast between hepatic impairment group versus the matched control (normal hepatic function) group.||321.48|80.77|
71057049|NCT03417778|141618866|OTHER|If the upper bound of the 2-sided 90% CIs of the GLSM ratio for AUClast of GS-829845 falls within the \[50%, 200%\] bound, the null hypothesis that participants with hepatic impairment exhibit AUClast change of at least 2-fold for GS-829845 compared with participants with normal liver function will be rejected.|GLSM Ratio|122.08|||||TWO_SIDED|90.0|69.67|213.89||||||An ANOVA model was fitted to the natural logarithmic transformed values of the AUClast. Two-sided 90% CI were calculated for the GLSM ratio of AUClast between hepatic impairment group versus the matched control (normal hepatic function) group.||213.89|69.67|
71057050|NCT03417778|141618867|OTHER|If the upper bound of the 2-sided 90% CIs of the GLSM ratio for AUCinf of filgotinib falls within the \[50%, 200%\] bound, the null hypothesis that participants with hepatic impairment exhibit AUCinf change of at least 2-fold for filgotinib compared with participants with normal liver function will be rejected.|GLSM Ratio|159.15|||||TWO_SIDED|90.0|82.22|308.06||||||An ANOVA model was fitted to the natural logarithmic transformed values of the AUCinf. Two-sided 90% CI were calculated for the GLSM ratio of AUCinf between hepatic impairment group versus the matched control (normal hepatic function) group.||308.06|82.22|
71057051|NCT03417778|141618868|OTHER|If the upper bound of the 2-sided 90% CIs of the GLSM ratio for AUCinf of GS-829845 falls within the \[50%, 200%\] bound, the null hypothesis that participants with hepatic impairment exhibit AUCinf change of at least 2-fold for GS-829845 compared with participants with normal liver function will be rejected.|GLSM Ratio|122.32|||||TWO_SIDED|90.0|69.9|214.07||||||An ANOVA model was fitted to the natural logarithmic transformed values of the AUCinf. Two-sided 90% CI were calculated for the GLSM ratio of AUCinf between hepatic impairment group versus the matched control (normal hepatic function) group.||214.07|69.90|
71057052|NCT03417778|141618869|OTHER|If the upper bound of the 2-sided 90% CIs of the GLSM ratio for Cmax of filgotinib falls within the \[50%, 200%\] bound, the null hypothesis that participants with hepatic impairment exhibit Cmax change of at least 2-fold for filgotinib compared with participants with normal liver function will be rejected.|GLSM Ratio|115.98|||||TWO_SIDED|90.0|58.75|228.98||||||An ANOVA model was fitted to the natural logarithmic transformed values of the Cmax. Two-sided 90% CI were calculated for the GLSM ratio of Cmax between hepatic impairment group versus the matched control (normal hepatic function) group.||228.98|58.75|
70934460|NCT02609048|141369734|SUPERIORITY||Difference in LSM|-1.4|STANDARD_ERROR_OF_MEAN|1.75||0.4431|TWO_SIDED|95.0|-4.9|2.2||Difference between means,p-value, and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor, baseline score as covariate, and change from baseline score as the response variable.|ANCOVA|||||2.2|-4.9|0.4431
70934461|NCT02609048|141369735|SUPERIORITY||Difference in LSM|-7.4|STANDARD_ERROR_OF_MEAN|10.07||0.4674|TWO_SIDED|95.0|-28.0|13.2||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model. Treatment group as factor, baseline score as a covariate, and change from baseline score as the response variable.|ANCOVA|||||13.2|-28.0|0.4674
70934462|NCT02609048|141369735|SUPERIORITY||Difference in LSM|-9.0|STANDARD_ERROR_OF_MEAN|8.99||0.3236|TWO_SIDED|95.0|-27.4|9.4||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model. Treatment group as factor, baseline score as a covariate, and change from baseline score as the response variable.|ANCOVA|||||9.4|-27.4|0.3236
70934463|NCT02609048|141369735|SUPERIORITY||Difference in LSM|1.6|STANDARD_ERROR_OF_MEAN|9.92||0.8723|TWO_SIDED|95.0|-18.7|21.9||Difference between means,p-value, and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model. Treatment group as factor, baseline score as a covariate, and change from baseline score as the response variable.|ANCOVA|||||21.9|-18.7|0.8723
71023871|NCT04549259|141555190|OTHER|Single group change over time.|Odds Ratio (OR)|0.92||||0.91|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.91
71023872|NCT04549259|141555191|SUPERIORITY||B|2.58|STANDARD_ERROR_OF_MEAN|2.8||0.36|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.36
71023873|NCT04549259|141555191|SUPERIORITY||B|-0.42|STANDARD_ERROR_OF_MEAN|2.78||0.88|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.88
71023874|NCT04549259|141555191|SUPERIORITY||B|0.38|STANDARD_ERROR_OF_MEAN|2.8||0.89|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.89
71023875|NCT04549259|141555191|SUPERIORITY||B|-0.99|STANDARD_ERROR_OF_MEAN|2.78||0.73|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.73
71023876|NCT04549259|141555191|OTHER|Single group change over time.|B|4.88|STANDARD_ERROR_OF_MEAN|1.83||0.01|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.01
71023877|NCT04549259|141555191|OTHER|Single group change over time.|B|3.28|STANDARD_ERROR_OF_MEAN|2.03||0.12|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.12
71023878|NCT04549259|141555191|OTHER|Single group change over time.|B|3.82|STANDARD_ERROR_OF_MEAN|2.06||0.08|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.08
71023879|NCT04549259|141555191|OTHER|Single group change over time.|B|3.19|STANDARD_ERROR_OF_MEAN|1.99||0.12|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.12
70934464|NCT02609048|141369736|SUPERIORITY||Difference in LSM|3.4|STANDARD_ERROR_OF_MEAN|1.25||0.0115|TWO_SIDED|95.0|0.8|6.0||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Cognitive Domain Score||6.0|0.8|0.0115
70934465|NCT02609048|141369736|SUPERIORITY||Difference in LSM|1.8|STANDARD_ERROR_OF_MEAN|1.1||0.1256|TWO_SIDED|95.0|-0.5|4.0||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Cognitive Domain Score||4.0|-0.5|0.1256
71023880|NCT04549259|141555192|SUPERIORITY||Odds Ratio (OR)|22.3||||0.049|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.049
71023881|NCT04549259|141555192|SUPERIORITY||Odds Ratio (OR)|1.86||||0.66|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.66
71057053|NCT03417778|141618870|OTHER|If the upper bound of the 2-sided 90% CIs of the GLSM ratio for Cmax of GS-829845 falls within the \[50%, 200%\] bound, the null hypothesis that participants with hepatic impairment exhibit Cmax change of at least 2-fold for GS-829845 compared with participants with normal liver function will be rejected.|GLSM Ratio|102.85|||||TWO_SIDED|90.0|60.12|175.98||||||An ANOVA model was fitted to the natural logarithmic transformed values of the Cmax. Two-sided 90% CI were calculated for the GLSM ratio of Cmax between hepatic impairment group versus the matched control (normal hepatic function) group.||175.98|60.12|
71057054|NCT01890434|141618913|SUPERIORITY||Sensitivity Difference|16.7||||9e-05|ONE_SIDED|95.0|9.3||||McNemar|McNemar one-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 1.|||9.3|0.00009
71057055|NCT01890434|141618913|SUPERIORITY||Sensitivity Difference|26.0|||<|0.0001|ONE_SIDED|95.0|18.2||||McNemar|McNemar one-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 2.|||18.2|<0.0001
71057056|NCT01890434|141618913|SUPERIORITY||Sensitivity Difference|32.0|||<|0.0001|ONE_SIDED|95.0|24.5||||McNemar|McNemar one-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 3.|||24.5|<0.0001
71057057|NCT01890434|141618914|SUPERIORITY||Sensitivity Difference|21.0||||5e-05|ONE_SIDED|95.0|12.1||||McNemar|McNemar one-sided test at alpha level of 2.5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 1.|||12.1|0.00005
71057058|NCT01890434|141618914|SUPERIORITY||Sensitivity Difference|36.2|||<|0.0001|ONE_SIDED|95.0|26.3||||McNemar|McNemar one-sided test at alpha level of 2.5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 2.|||26.3|<0.0001
71057059|NCT01890434|141618914|SUPERIORITY||Sensitivity Difference|41.0|||<|0.0001|ONE_SIDED|95.0|31.8||||McNemar|McNemar one-sided test at alpha level of 2.5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 3.|||31.8|<0.0001
71057060|NCT01890434|141618919|SUPERIORITY||Sensitivity Difference|21.3|||<|0.0001|TWO_SIDED|95.0|12.9|28.4|||McNemar|McNemar 2-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI.||28.4|12.9|<0.0001
71057061|NCT01890434|141618919|SUPERIORITY||Sensitivity Difference|21.3|||<|0.0001|TWO_SIDED|90.0|14.2|27.2|||McNemar|McNemar 2-sided test at alpha level of 10%||||27.2|14.2|<0.0001
71023882|NCT04549259|141555192|SUPERIORITY||Odds Ratio (OR)|0.68||||0.78|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.78
71023883|NCT04549259|141555192|SUPERIORITY||Odds Ratio (OR)|0.43||||0.54|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.54
71023884|NCT04549259|141555192|OTHER|Single group change over time.|Odds Ratio (OR)|6.26||||0.09|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.09
71023885|NCT04549259|141555192|OTHER|Single group change over time.|Odds Ratio (OR)|2.05||||0.4|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.40
71023886|NCT04549259|141555192|OTHER|Single group change over time.|Odds Ratio (OR)|1.42||||0.66|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.66
71023887|NCT04549259|141555192|OTHER|Single group change over time.|Odds Ratio (OR)|1.14||||0.87|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.87
71023888|NCT04549259|141555193|SUPERIORITY||B|-1.74|STANDARD_ERROR_OF_MEAN|1.47||0.24|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.24
71057062|NCT01890434|141618921|NON_INFERIORITY|A non-inferiority margin was set as 15%|Sensitivity Difference|5.7||||0.2733|TWO_SIDED|95.0|-5.4|14.9|||McNemar|McNemar 2-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of GSPECT evaluated by majority BR.||14.9|-5.4|0.2733
71057063|NCT01890434|141618921|NON_INFERIORITY|A non-inferiority margin was set as 15%.|Sensitivity Difference|0.0||||1|TWO_SIDED|95.0|-8.6|7.2|||McNemar|McNemar 2-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of GSPECT evaluated by investigator.||7.2|-8.6|1.0000
71057064|NCT01890434|141618923|NON_INFERIORITY|A non-inferiority margin was set as 15%.|Specificity Difference|11.1||||0.001|TWO_SIDED|95.0|4.1|17.0|||McNemar|McNemar 2-sided test at alpha level of 5%||Specificity of gadobutrol-enhanced CMRI was compared with specificity of GSPECT by majority BR.||17.0|4.1|0.0010
70934466|NCT02609048|141369736|SUPERIORITY||Difference in LSM|1.7|STANDARD_ERROR_OF_MEAN|1.22||0.1842|TWO_SIDED|95.0|-0.9|4.2||Difference between means,p-value,and CIs are estimated comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Cognitive Domain Score||4.2|-0.9|0.1842
70934467|NCT02609048|141369736|SUPERIORITY||Difference in LSM|3.7|STANDARD_ERROR_OF_MEAN|1.7||0.042|TWO_SIDED|95.0|0.1|7.2||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Social Domain Score||7.2|0.1|0.0420
70934468|NCT02609048|141369736|SUPERIORITY||Difference in LSM|0.7|STANDARD_ERROR_OF_MEAN|1.54||0.6384|TWO_SIDED|95.0|-2.4|3.9||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Social Domain Score||3.9|-2.4|0.6384
71057065|NCT01890434|141618923|NON_INFERIORITY|A non-inferiority margin was set as 15%.|Specificity Difference|7.8||||0.0094|TWO_SIDED|95.0|1.6|13.2|||McNemar|McNemar 2-sided test at alpha level of 5%||Specificity of gadobutrol-enhanced CMRI was compared with specificity of GSPECT by investigator.||13.2|1.6|0.0094
71057066|NCT03852537|141618938|SUPERIORITY|||||||0.494|||||||Fisher Exact|||||||0.494
71057067|NCT03852537|141618939|SUPERIORITY|||||||0.666|||||||Fisher Exact|||||||0.666
71057068|NCT03852537|141618940|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71057069|NCT03852537|141618942|SUPERIORITY|||||||0.477|||||||Fisher Exact|||||||0.477
71057070|NCT03852537|141618943|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.000
71057071|NCT03852537|141618944|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71108005|NCT02949011|141721546|SUPERIORITY||Median Difference|-15.1||||0.0013||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.0013
71108006|NCT02949011|141721546|SUPERIORITY||Median Difference|2.3||||0.8498||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.8498
70941678|NCT04748445|141383934|OTHER||Slope|-3.105|STANDARD_ERROR_OF_MEAN|3.256||0.9242|TWO_SIDED|90.0|-5.706|5.085|||Mixed Models Analysis|||MM\_SNR (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-2. For estimated value it was 10\^-3).||5.085|-5.706|0.9242
71023889|NCT04549259|141555193|SUPERIORITY||B|-2.05|STANDARD_ERROR_OF_MEAN|1.46||0.17|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.17
71023890|NCT04549259|141555193|SUPERIORITY||B|0.64|STANDARD_ERROR_OF_MEAN|1.47||0.66|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.66
71023891|NCT04549259|141555193|SUPERIORITY||B|-0.21|STANDARD_ERROR_OF_MEAN|1.46||0.89|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.89
71057072|NCT03852537|141618945|SUPERIORITY|||||||0.011|||||||Fisher Exact|||||||0.011
71057073|NCT03852537|141618946|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71057074|NCT03852537|141618948|SUPERIORITY|||||||0.213|||||||Chi-squared|||||||0.213
71057075|NCT05199090|141618983|OTHER||adjusted means|-1.9||||0.0182|TWO_SIDED|80.0|-2.9|-0.9|||MMRM analysis|||Comparison of adjusted means||-0.9|-2.9|0.0182
71057076|NCT05199090|141618983|OTHER||adjusted means|-1.3||||0.1205|TWO_SIDED|80.0|-2.4|-0.2|||MMRM analysis|||||-0.2|-2.4|0.1205
71057077|NCT05199090|141618983|OTHER||adjusted means|-1.3||||0.0931|TWO_SIDED|80.0|-2.2|-0.3|||MMRM analysis|||||-0.3|-2.2|0.0931
71057078|NCT05199090|141618983|OTHER||adjusted means|0.6||||0.4994|TWO_SIDED|80.0|-0.5|1.7|||MMRM analysis|||||1.7|-0.5|0.4994
71057079|NCT05199090|141618983|OTHER||adjusted means|1.0||||0.2295|TWO_SIDED|80.0|-0.1|2.1|||MMRM analysis|||||2.1|-0.1|0.2295
71057080|NCT05199090|141618983|OTHER||adjusted means|-0.7||||0.2114|TWO_SIDED|80.0|-1.3|0.0|||MMRM analysis|||||0.0|-1.3|0.2114
71057081|NCT01004003|141619062|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.437|||||TWO_SIDED|95.0|0.805|2.565|||||"Hazard ratio (HR) from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||2.565|0.805|
71057082|NCT01004003|141619065|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.351|||||TWO_SIDED|95.0|0.779|2.343|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||2.343|0.779|
71057083|NCT01004003|141619066|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.877|||||TWO_SIDED|95.0|0.522|1.473|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||1.473|0.522|
71057084|NCT05819203|141619071|SUPERIORITY|||||||0.0013|||||||Wilcoxon (Mann-Whitney)|||Comparison of the means of AUC on global score or ARSSQ during the first 10 days of the study between both groups.||||0.0013
71057085|NCT05819203|141619072|SUPERIORITY|||||||0.0209|||||||Cox survival regression and p Wald|||Comparison of the mean duration of common cold during the study between both groups.||||0.0209
70934469|NCT02609048|141369736|SUPERIORITY||Difference in LSM|2.9|STANDARD_ERROR_OF_MEAN|1.73||0.1035|TWO_SIDED|95.0|-0.6|6.5||Difference between means,p-value,and CIs are estimated comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Social Domain Score||6.5|-0.6|0.1035
70934470|NCT02609048|141369736|SUPERIORITY||Difference in LSM|0.4|STANDARD_ERROR_OF_MEAN|0.96||0.6967|TWO_SIDED|95.0|-1.6|2.4||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Emotional Function Domain Score||2.4|-1.6|0.6967
70934471|NCT02609048|141369736|SUPERIORITY||Difference in LSM|0.4|STANDARD_ERROR_OF_MEAN|0.85||0.6164|TWO_SIDED|95.0|-1.3|2.2||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Emotional Function Domain Score||2.2|-1.3|0.6164
70934472|NCT02609048|141369736|SUPERIORITY||Difference in LSM|-0.1|STANDARD_ERROR_OF_MEAN|0.93||0.9548|TWO_SIDED|95.0|-2.0|1.9|||ANCOVA|||Emotional Function Domain Score||1.9|-2.0|0.9548
70934473|NCT02609048|141369736|SUPERIORITY||Difference in LSM|-0.2|STANDARD_ERROR_OF_MEAN|1.04||0.8286|TWO_SIDED|95.0|-2.4|1.9||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Itch Domain Score||1.9|-2.4|0.8286
71023892|NCT04549259|141555193|OTHER|Single group change over time.|B|-1.6|STANDARD_ERROR_OF_MEAN|0.75||0.045|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.045
71023893|NCT04549259|141555193|OTHER|Single group change over time.|B|-1.81|STANDARD_ERROR_OF_MEAN|0.95||0.07|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.07
71023894|NCT04549259|141555193|OTHER|Single group change over time.|B|-0.51|STANDARD_ERROR_OF_MEAN|0.88||0.57|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.57
71023895|NCT04549259|141555193|OTHER|Single group change over time.|B|-0.92|STANDARD_ERROR_OF_MEAN|1.12||0.42|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.42
71023896|NCT02884206|141555194|NON_INFERIORITY|To demonstrate non-inferiority that LCZ696 does not lead to a relevant decrease in cognition compared to valsartan at year 3, the lower bound of 95% CI does not include the pre-specified non-inferiority (NI) boundary (Cohen's D) of -0.3. An effect size of 0.3 in Cohen's D is generally considered as small.|LSM|-0.018||||0.7363|TWO_SIDED|95.0|-0.123|0.087|||ANCOVA|||Repeated measure ANCOVA|Cohen's D: -0.0277, 95% CI: -0.1101 to 0.0778|0.0870|-0.1230|0.7363
71023897|NCT02884206|141555195|NON_INFERIORITY|To show that the point estimate of SUVr difference in mean change over 3 years is in favor of LCZ696 and the non-inferiority is demonstrated, with the upper bound of the 95% CI excluding the NI boundary of 0.01.|Least Squares Mean|-0.0292||||0.0579|TWO_SIDED|95.0|-0.0593|0.001|||ANCOVA|||Multiple Imputation ANCOVA in Global cortical composite||0.0010|-0.0593|0.0579
71023898|NCT02884206|141555196|SUPERIORITY||Least Squares Mean|0.0007||||0.9916|TWO_SIDED|95.0|-0.1339|0.1353|||ANCOVA|||Repeated measure ANCOVA for memory domain|Cohen's D: 0.0009; 95% CI: -0.0912 to 0.0922|0.1353|-0.1339|0.9916
71023899|NCT02884206|141555196|SUPERIORITY||Least Squares Mean|0.0327||||0.6348|TWO_SIDED|95.0|-0.1024|0.1677|||ANCOVA|||Repeated measure ANCOVA for executive function domain|Cohen's D: 0.0391, 95% CI: -0.0727 to 0.1192|0.1677|-0.1024|0.6348
71023900|NCT02884206|141555196|SUPERIORITY||Least Squares Mean|-0.1042||||0.2403|TWO_SIDED|95.0|-0.2783|0.07|||ANCOVA|||Repeated measure ANCOVA for attention domain|Cohen's D: -0.0967, 95% CI: -0.1542 to 0.0387|0.0700|-0.2783|0.2403
71023901|NCT02884206|141555197|SUPERIORITY||Least Squares Mean|-0.1105||||0.7081|TWO_SIDED|95.0|-0.6906|0.4696|||ANCOVA|||Repeated measure ANCOVA|Cohen's D: -0.0308, 95% CI: -0.1208 to 0.0820|0.4696|-0.6906|0.7081
71057086|NCT05819203|141619073|SUPERIORITY|||||||0.0399|||||||Cox survival regression and p Wald|||Comparison of the mean duration of impact of common cold on quality of life during the study between both groups.||||0.0399
71057087|NCT05819203|141619074|SUPERIORITY|||||||0.0015|||||||Poisson regression|||||||0.0015
71057088|NCT05819203|141619075|SUPERIORITY||||||>|0.05||||||not significant|Poisson regression|||||||>0.05
71057089|NCT05819203|141619076|SUPERIORITY|||||||0.0029|||||||Poisson regression|||||||0.0029
71057090|NCT05819203|141619077|SUPERIORITY|||||||0.0006|||||||Poisson regression|||||||0.0006
71057091|NCT05819203|141619078|SUPERIORITY|||||||0.0513|||||||Poisson regression|||||||0.0513
70934474|NCT02609048|141369736|SUPERIORITY||Difference in LSM|4.2|STANDARD_ERROR_OF_MEAN|1.74||0.0226|TWO_SIDED|95.0|0.6|7.8||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Fatigue Domain Score||7.8|0.6|0.0226
70934475|NCT02609048|141369736|SUPERIORITY||Difference in LSM|-2.6|STANDARD_ERROR_OF_MEAN|1.92||0.1861|TWO_SIDED|95.0|-6.6|1.4||Difference between means,p-value,and CIs are estimated comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Fatigue Domain Score||1.4|-6.6|0.1861
70934476|NCT02609048|141369736|SUPERIORITY||Difference in LSM|1.6|STANDARD_ERROR_OF_MEAN|1.96||0.4159|TWO_SIDED|95.0|-2.4|5.7||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Fatigue Domain Score||5.7|-2.4|0.4159
71023902|NCT00672620|141555224|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|1.036||0.577|TWO_SIDED|95.0|-2.61|1.46||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.05, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|ANCOVA|ANCOVA with treatment and center as fixed factors, baseline HAM-D24 as covariate.||All statistical tests were 2-sided with 95% confidence intervals (CIs), and with P-values evaluated at the 5% significance level (ie, statistical significance if P\<0.05). To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 5 mg and 2.5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.05, the testing procedure stopped for all subsequent endpoints.||1.46|-2.61|0.577
71023903|NCT00672620|141555224|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.54|STANDARD_ERROR_OF_MEAN|1.038||0.138|TWO_SIDED|95.0|-3.58|0.5|||ANCOVA|ANCOVA with treatment and center as fixed factors, baseline HAM-D24 as covariate.||||0.50|-3.58|0.138
71023904|NCT00672620|141555224|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.96|STANDARD_ERROR_OF_MEAN|1.047||0.005|TWO_SIDED|95.0|-5.02|-0.91|||ANCOVA|ANCOVA with treatment and center as fixed factors, baseline HAM-D24 as covariate.||||-0.91|-5.02|0.005
71023905|NCT03211156|141555241|OTHER|||||||0.757|||||||Chi-squared, Corrected|||||||0.757
71023906|NCT03211156|141555242|OTHER|||||||0.048|||||||Fisher Exact|||||||0.048
71023907|NCT03255031|141555243|SUPERIORITY|||||||0.067||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||||||0.067
71023908|NCT03255031|141555244|SUPERIORITY|||||||0.004||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||||||0.004
71023909|NCT03563027|141555253|SUPERIORITY||Mean Difference (Net)|433.0||||0.81|TWO_SIDED|95.0|-337.0|1203.0|||Regression, Linear|||||1203|-337|.81
70934477|NCT02609048|141369736|SUPERIORITY||Difference in LSM|0.7|STANDARD_ERROR_OF_MEAN|0.93||0.4848|TWO_SIDED|95.0|-1.3|2.6||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Itch Domain Score||2.6|-1.3|0.4848
70934478|NCT02609048|141369736|SUPERIORITY||Difference in LSM|-0.9|STANDARD_ERROR_OF_MEAN|1.05||0.4048|TWO_SIDED|95.0|-3.1|1.3||Difference between means,p-value,and CIs are estimated comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Itch Domain Score||1.3|-3.1|0.4048
71023910|NCT03563027|141555253|SUPERIORITY||Mean Difference (Net)|1224.0||||0.005|TWO_SIDED|95.0|451.0|1996.0|||Regression, Linear|||||1996|451|.005
71023911|NCT03563027|141555254|SUPERIORITY||Mean Difference (Net)|-160.0||||0.92|TWO_SIDED|95.0|-983.0|663.0|||Regression, Linear|||||663|-983|.92
71023912|NCT03563027|141555254|SUPERIORITY||Mean Difference (Net)|564.0||||0.37|TWO_SIDED|95.0|-261.0|1389.0|||Regression, Linear|||||1389|-261|.37
71023913|NCT03563027|141555255|SUPERIORITY||Median Difference (Net)|0.21|||<|0.001|TWO_SIDED|95.0|0.18|0.24|||Regression, Linear|||||.24|.18|<.001
71023914|NCT03563027|141555255|SUPERIORITY||Mean Difference (Net)|0.34|||<|0.001|TWO_SIDED|95.0|0.31|0.37|||Regression, Linear|||||.37|.31|<.001
71023915|NCT03563027|141555256|SUPERIORITY||Mean Difference (Net)|0.09|||<|0.001|TWO_SIDED|95.0|0.06|0.1|||Regression, Linear|||||0.1|.06|<.001
71023916|NCT03563027|141555256|SUPERIORITY||Median Difference (Net)|0.18|||<|0.001|TWO_SIDED|95.0|0.15|0.2|||Regression, Linear|||||.20|.15|<.001
71023917|NCT00415532|141555257|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.172|||<|0.0001||95.0|0.084|0.352||Significant level is set at 0.05|Cochran-Mantel-Haenszel|||||0.352|0.084|<0.0001
71023918|NCT00415532|141555258|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.307||||0.0005||95.0|0.154|0.611||Significant level is set at 0.05|Cochran-Mantel-Haenszel|||||0.611|0.154|0.0005
71023919|NCT00415532|141555261|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0133||||||Significant level is set at 0.05|Mixed Models Analysis|||||||0.0133
70934479|NCT02609048|141369736|SUPERIORITY||Difference in LSM|2.6|STANDARD_ERROR_OF_MEAN|1.0||0.0141|TWO_SIDED|95.0|0.6|4.7||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Symptoms Domain Score||4.7|0.6|0.0141
71023920|NCT00415532|141555262|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3434||||||Significant level is set at 0.05|Mixed Models Analysis|||||||0.3434
71023921|NCT00415532|141555263|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0076||||||Significant level is set at 0.05|Mixed Models Analysis|||||||0.0076
71023922|NCT00415532|141555264|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0246||||||Significant level is set at 0.05|Mixed Models Analysis|||||||0.0246
71057092|NCT05819203|141619079|SUPERIORITY|||||||0.0789|||||||Poisson regression|||||||0.0789
71057093|NCT05819203|141619080|SUPERIORITY||||||<|0.0001|||||||Poisson regression|||||||<0.0001
71057094|NCT05819203|141619081|SUPERIORITY|Comparison of the means of AUC on global score or ARSSQ during the first 10 days of the study between both groups.||||||0.0034|||||||t-test, 2 sided|||||||0.0034
71057095|NCT02521376|141619086|OTHER||Geometric Mean Ratio (GMR)|43.69|||||TWO_SIDED|90.0|24.59|77.62||||||||77.62|24.59|
71057096|NCT02521376|141619086|OTHER||GMR|233.63|||||TWO_SIDED|90.0|141.85|384.79||||||||384.79|141.85|
71057097|NCT02521376|141619086|OTHER||GMR|219.2|||||TWO_SIDED|90.0|139.74|343.84||||||||343.84|139.74|
71023923|NCT01154153|141555334|SUPERIORITY_OR_OTHER||Treatment Ratio of Geometric mean|0.966|||||TWO_SIDED|95.0|0.892|1.045|||ANCOVA||The treatment ratio was calculated as an exponential of the mean difference between treatments in log scale.|Missing cortisol values were imputed with multiple imputation. AUC(0-24 hr) was calculated for each imputation and analyzed with log-transformation using an ANCOVA model and analyzed with treatment, sex, and age group as fixed effects, and log-transformed baseline value as a covariate. The mean difference in log scale between treatments and its standard error were calculated by Least Squares mean. Results from multiply imputed data were combined using SAS procedure MIANALYZE.||1.045|0.892|
71023924|NCT01154153|141555335|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.24||0.0007|TWO_SIDED|95.0|-1.34|-0.37|||ANCOVA|For ANCOVA, treatment arm, randomization strata were fixed effects and baseline value was a covariate.||||-0.37|-1.34|0.0007
70934480|NCT02609048|141369736|SUPERIORITY||Difference in LSM|2.4|STANDARD_ERROR_OF_MEAN|0.9||0.0138|TWO_SIDED|95.0|0.5|4.2||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Symptoms Domain Score||4.2|0.5|0.0138
70934481|NCT02609048|141369736|SUPERIORITY||Difference in LSM|0.3|STANDARD_ERROR_OF_MEAN|0.98||0.7911|TWO_SIDED|95.0|-1.8|2.3||Difference between means,p-value,and CIs are estimated comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Symptoms Domain Score||2.3|-1.8|0.7911
70934482|NCT02485925|141369737|OTHER||Proportion of participants|80.7|||||TWO_SIDED|95.0|73.9|86.4|||||||95% confidence interval is based on Clopper-Pearson confidence interval|86.4|73.9|
71057098|NCT02521376|141619086|OTHER||GMR|108.5|||||TWO_SIDED|90.0|77.2|152.48||||||||152.48|77.20|
70934483|NCT02485925|141369738|OTHER||Proportion of participants|99.5|||||TWO_SIDED|95.0|97.2|100.0|||||||95% confidence interval is based on Clopper-Pearson confidence interval|100.0|97.2|
70934484|NCT04181788|141369747|OTHER|Ratio of experimental vs control|Ratio of experimental vs control|231.2|||||TWO_SIDED|90.0|190.09|281.21||||||Phase 2 600 mg SC Q6W (experimental) vs. Phase 2 300 mg SC Q4W (control)||281.21|190.09|
70934485|NCT04181788|141369748|OTHER|Ratio of experimental vs control|Ratio of experimental vs control|111.48|||||TWO_SIDED|90.0|86.31|143.99||||||Phase 2 600 mg SC Q6W (experimental) vs. Phase 2 300 mg SC Q4W (control)||143.99|86.31|
70934486|NCT06922643|141369772|OTHER||Odds Ratio (OR)|6.73||||0.008|TWO_SIDED|95.0|1.63|27.8|||Regression, Logistic|||||27.8|1.63|0.008
70934487|NCT02678455|141369777|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.216|0.141|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Erythema||0.141|-0.216|
71057099|NCT02521376|141619087|OTHER||GMR|55.71|||||TWO_SIDED|90.0|34.7|89.42||||||||89.42|34.70|
71057100|NCT02521376|141619087|OTHER||GMR|211.94|||||TWO_SIDED|90.0|132.49|339.03||||||||339.03|132.49|
71057101|NCT02521376|141619087|OTHER||GMR|171.33|||||TWO_SIDED|90.0|108.17|271.37||||||||271.37|108.17|
71057102|NCT02521376|141619087|OTHER||GMR|107.35|||||TWO_SIDED|90.0|72.71|158.51||||||||158.51|72.71|
71057103|NCT03597464|141619110|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|2.3||||0.004|TWO_SIDED|95.0|1.3|4.05|||Regression, Logistic|||Month 12 (AURORA 2 baseline)||4.05|1.30|0.004
71057104|NCT03597464|141619110|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|2.19||||0.006|TWO_SIDED|95.0|1.25|3.83|||Regression, Logistic|||Month 18||3.83|1.25|0.006
71057105|NCT03597464|141619110|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|1.81||||0.035|TWO_SIDED|95.0|1.04|3.16|||Regression, Logistic|||Month 24||3.16|1.04|0.035
71057106|NCT03597464|141619110|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|2.24||||0.005|TWO_SIDED|95.0|1.28|3.92|||Regression, Logistic|||Month 30||3.92|1.28|0.005
71057107|NCT03597464|141619110|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|1.74||||0.051|TWO_SIDED|95.0|1.0|3.03|||Regression, Logistic|||Month 36||3.03|1.00|0.051
71057108|NCT03597464|141619111|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|3.99|||<|0.001|TWO_SIDED|95.0|1.88|8.46|||Regression, Logistic|||Month 12 (AURORA 2 baseline)||8.46|1.88|<0.001
71057109|NCT03597464|141619111|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|2.5||||0.008|TWO_SIDED|95.0|1.28|4.88|||Regression, Logistic|||Month 18||4.88|1.28|0.008
71057110|NCT03597464|141619111|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|2.68||||0.001|TWO_SIDED|95.0|1.46|4.91|||Regression, Logistic|||Month 24||4.91|1.46|0.001
71057111|NCT03597464|141619111|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|1.86||||0.04|TWO_SIDED|95.0|1.03|3.34|||Regression, Logistic|||Month 30||3.34|1.03|0.040
71023925|NCT01154153|141555336|SUPERIORITY_OR_OTHER|||||||0.1332||95.0||||Based on the ordinal evaluation score and adjusted for the randomization strata.|Cochran-Mantel-Haenszel|||||||0.1332
71023926|NCT01154153|141555337|SUPERIORITY_OR_OTHER|||||||0.3314||95.0||||Based on the ordinal evaluation score and adjusted for the randomization strata.|Cochran-Mantel-Haenszel|||||||0.3314
71023927|NCT00210626|141555340|SUPERIORITY_OR_OTHER|||||||0.3807||95.0|||||ANCOVA|Covariate used is Baseline SF-36 PF Score. Baseline SF-36 PF Score was collected prior to the start of Procrit or Placebo treatment||The null hypothesis is that there is no difference between Procrit and Placebo in average SF-36 Physical Function Scores||||0.3807
71023928|NCT00210626|141555341|SUPERIORITY_OR_OTHER|||||||0.7038||95.0|||||Chi-squared|||||||0.7038
71023929|NCT01227668|141555342|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.097|TWO_SIDED|95.0|0.28|1.12|||Stratified log rank|||||1.12|0.28|0.097
71023930|NCT01227668|141555343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.051|TWO_SIDED|95.0|-8.82|0.02||For secondary endpoints, hierarchical testing aimed to keep the overall experiment-wise type I error rate to \<=0.05. Difference in chg from BL was tested at 0.05 significance only if APR arm significantly differed vs placebo from primary analysis.|ANCOVA|||||0.02|-8.82|0.051
71023931|NCT01227668|141555344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.09|TWO_SIDED|95.0|-1.3|0.1||Treatment diff in chg from BL to endpnt in IS score was tested at 0.05 signif only if ARP arm signif differed vs pb from PA. Thus, if ARP arm signif differed vs pb in IS score, treatment diff in mean CGI-I score at endpnt was tested at 0.05 signfnce.|ANCOVA|||||0.1|-1.3|0.090
71023932|NCT02473510|141555347|SUPERIORITY_OR_OTHER||Rate Difference|0.4|||||TWO_SIDED|95.0|-5.2|2.6||||||||2.6|-5.2|
71023933|NCT02473510|141555348|SUPERIORITY_OR_OTHER||Rate Difference|16.7|||||TWO_SIDED|95.0|3.6|27.6||||||Up to Day 8||27.6|3.6|
71023934|NCT02473510|141555348|SUPERIORITY_OR_OTHER||Rate Difference|17.9|||||TWO_SIDED|95.0|4.4|29.3||||||Up to Day 15||29.3|4.4|
71023935|NCT01086215|141555376|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \>0||||||<0.0001
71023936|NCT01086215|141555376|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \>0||||||<0.0001
71023937|NCT01086215|141555376|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \>0||||||<0.0001
71023938|NCT01086215|141555376|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \>0||||||<0.0001
71023939|NCT02524106|141555379|OTHER||percentage difference|61.0||||0.028|TWO_SIDED||||||Mixed Models Analysis|||||||0.028
71023940|NCT02524106|141555380|OTHER||percentage difference|39.0||||0.096|TWO_SIDED||||||Mixed Models Analysis|||||||0.096
71023941|NCT00408876|141555415|SUPERIORITY_OR_OTHER|||||||0.503||95.0|||||Repeated Measures|||||||0.503
71023942|NCT00408876|141555415|SUPERIORITY_OR_OTHER|||||||0.447||95.0|||||Repeated Measures|||||||0.447
70934488|NCT02678455|141369777|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.216|0.141|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Swelling||0.141|-0.216|
71023943|NCT00408876|141555415|SUPERIORITY_OR_OTHER|||||||0.084||95.0|||||Repeated Measures|||||||0.084
71023944|NCT00408876|141555415|SUPERIORITY_OR_OTHER|||||||0.964||95.0|||||Repeated Measures|||||||0.964
71023945|NCT00408876|141555415|SUPERIORITY_OR_OTHER|||||||0.451||95.0|||||Repeated Measures|||||||0.451
71023946|NCT00408876|141555415|SUPERIORITY_OR_OTHER|||||||0.333||95.0|||||Repeated Measures|||||||0.333
71023947|NCT00408876|141555416|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21||||0.318||95.0|-0.62|0.2|||t-test, 2 sided|||||0.20|-0.62|0.318
71023948|NCT00408876|141555416|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49||||0.005||95.0|-0.83|-0.15|||t-test, 2 sided|||||-0.15|-0.83|0.005
71023949|NCT00408876|141555416|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.124||95.0|-0.61|0.07|||t-test, 2 sided|||||0.07|-0.61|0.124
71023950|NCT00408876|141555416|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28||||0.183||95.0|-0.7|0.13|||t-test, 2 sided|||||0.13|-0.70|0.183
71023951|NCT00408876|141555416|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.778||95.0|-0.48|0.36|||t-test, 2 sided|||||0.36|-0.48|0.778
71023952|NCT00408876|141555416|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22||||0.21||95.0|-0.13|0.57|||t-test, 2 sided|||||0.57|-0.13|0.210
71023953|NCT00408876|141555417|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.97||||0.161||95.0|-2.32|0.39|||t-test, 2 sided|||||0.39|-2.32|0.161
71023954|NCT00408876|141555417|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.41||||0.019||95.0|-2.59|-0.24|||t-test, 2 sided|||||-0.24|-2.59|0.019
71023955|NCT00408876|141555417|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.56||||0.01||95.0|-2.74|-0.38|||t-test, 2 sided|||||-0.38|-2.74|0.010
71023956|NCT00408876|141555417|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.45||||0.526||95.0|-1.83|0.94|||t-test, 2 sided|||||0.94|-1.83|0.526
71023957|NCT00408876|141555417|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59||||0.397||95.0|-1.96|0.78|||t-test, 2 sided|||||0.78|-1.96|0.397
71023958|NCT00408876|141555417|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.813||95.0|-1.35|1.06|||t-test, 2 sided|||||1.06|-1.35|0.813
71023959|NCT00408876|141555418|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15||||0.657||95.0|-0.5|0.79|||t-test, 2 sided|||||0.79|-0.50|0.657
71023960|NCT00408876|141555418|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.23||||0.384||95.0|-0.76|0.29|||t-test, 2 sided|||||0.29|-0.76|0.384
71023961|NCT00408876|141555418|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56||||0.04||95.0|-1.1|-0.03|||t-test, 2 sided|||||-0.03|-1.10|0.040
71023962|NCT00408876|141555418|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.38||||0.253||95.0|-1.03|0.27|||t-test, 2 sided|||||0.27|-1.03|0.253
71023963|NCT00408876|141555418|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.71||||0.034||95.0|-1.36|-0.05|||t-test, 2 sided|||||-0.05|-1.36|0.034
71023964|NCT00408876|141555418|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.33||||0.232||95.0|-0.86|0.21|||t-test, 2 sided|||||0.21|-0.86|0.232
71023965|NCT00408876|141555419|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33||||0.365||95.0|-0.39|1.05|||t-test, 2 sided|||||1.05|-0.39|0.365
71023966|NCT00408876|141555419|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.232||95.0|-0.95|0.23|||t-test, 2 sided|||||0.23|-0.95|0.232
71023967|NCT00408876|141555419|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.314||95.0|-0.9|0.29|||t-test, 2 sided|||||0.29|-0.90|0.314
71023968|NCT00408876|141555419|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.69||||0.062||95.0|-1.41|0.03|||t-test, 2 sided|||||0.03|-1.41|0.062
70934489|NCT02678455|141369777|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.135|0.119|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|ALT Increased||0.119|-0.135|
71023969|NCT00408876|141555419|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64||||0.083||95.0|-1.36|0.08|||t-test, 2 sided|||||0.08|-1.36|0.083
71023970|NCT00408876|141555419|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.859||95.0|-0.54|0.65|||t-test, 2 sided|||||0.65|-0.54|0.859
71023971|NCT00408876|141555420|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.984||95.0|-0.34|0.34|||t-test, 2 sided|||||0.34|-0.34|0.984
71023972|NCT00408876|141555420|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41||||0.004||95.0|-0.7|-0.13|||t-test, 2 sided|||||-0.13|-0.70|0.004
71023973|NCT00408876|141555420|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53|||<|0.001||95.0|-0.81|-0.24|||t-test, 2 sided|||||-0.24|-0.81|<0.001
71023974|NCT00408876|141555420|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42||||0.018||95.0|-0.76|-0.07|||t-test, 2 sided|||||-0.07|-0.76|0.018
71023975|NCT00408876|141555420|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53||||0.003||95.0|-0.87|-0.19|||t-test, 2 sided|||||-0.19|-0.87|0.003
71023976|NCT00408876|141555420|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.442||95.0|-0.4|0.17|||t-test, 2 sided|||||0.17|-0.40|0.442
71023977|NCT00408876|141555421|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.31||||0.464||95.0|-0.52|1.14|||t-test, 2 sided|||||1.14|-0.52|0.464
71023978|NCT00408876|141555421|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.68||||0.052||95.0|-1.36|0.0|||t-test, 2 sided|||||0.00|-1.36|0.052
71023979|NCT00408876|141555421|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.68||||0.052||95.0|-1.37|0.01|||t-test, 2 sided|||||0.01|-1.37|0.052
71023980|NCT00408876|141555421|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.99||||0.021||95.0|-1.83|-0.15|||t-test, 2 sided|||||-0.15|-1.83|0.021
71023981|NCT00408876|141555421|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.99||||0.02||95.0|-1.83|-0.16|||t-test, 2 sided|||||-0.16|-1.83|0.020
71023982|NCT00408876|141555421|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.988||95.0|-0.7|0.69|||t-test, 2 sided|||||0.69|-0.70|0.988
71023983|NCT00408876|141555422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21||||0.543||95.0|-0.46|0.88|||t-test, 2 sided|||||0.88|-0.46|0.543
71023984|NCT00408876|141555422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.55||||0.053||95.0|-1.1|0.01|||t-test, 2 sided|||||0.01|-1.10|0.053
71023985|NCT00408876|141555422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.65||||0.024||95.0|-1.21|-0.09|||t-test, 2 sided|||||-0.09|-1.21|0.024
70934490|NCT02678455|141369777|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.135|0.119|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Hemoglobin Decreased||0.119|-0.135|
71023986|NCT00408876|141555422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.75||||0.03||95.0|-1.43|-0.07|||t-test, 2 sided|||||-0.07|-1.43|0.030
71023987|NCT00408876|141555422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.85||||0.014||95.0|-1.54|-0.17|||t-test, 2 sided|||||-0.17|-1.54|0.014
71023988|NCT00408876|141555422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.727||95.0|-0.66|0.46|||t-test, 2 sided|||||0.46|-0.66|0.727
71023989|NCT00408876|141555423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.813||95.0|-0.63|0.8|||t-test, 2 sided|||||0.80|-0.63|0.813
71023990|NCT00408876|141555423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.63||||0.035||95.0|-1.21|-0.04|||t-test, 2 sided|||||-0.04|-1.21|0.035
71023991|NCT00408876|141555423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.58||||0.054||95.0|-1.17|0.01|||t-test, 2 sided|||||0.01|-1.17|0.054
71023992|NCT00408876|141555423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.71||||0.051||95.0|-1.43|0.0|||t-test, 2 sided|||||0.00|-1.43|0.051
71023993|NCT00408876|141555423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.67||||0.07||95.0|-1.39|0.05|||t-test, 2 sided|||||0.05|-1.39|0.070
71023994|NCT00408876|141555423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.872||95.0|-0.54|0.64|||t-test, 2 sided|||||0.64|-0.54|0.872
71023995|NCT00408876|141555424|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.79||95.0|-0.68|0.89|||t-test, 2 sided|||||0.89|-0.68|0.790
71023996|NCT00408876|141555424|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.93||||0.005||95.0|-1.57|-0.28|||t-test, 2 sided|||||-0.28|-1.57|0.005
71023997|NCT00408876|141555424|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.87||||0.009||95.0|-1.52|-0.22|||t-test, 2 sided|||||-0.22|-1.52|0.009
71023998|NCT00408876|141555424|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.03||||0.011||95.0|-1.83|-0.24|||t-test, 2 sided|||||-0.24|-1.83|0.011
71023999|NCT00408876|141555424|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.97||||0.016||95.0|-1.77|-0.18|||t-test, 2 sided|||||-0.18|-1.77|0.016
71024000|NCT00408876|141555424|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06||||0.857||95.0|-0.6|0.72|||t-test, 2 sided|||||0.72|-0.60|0.857
71024001|NCT00408876|141555425|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.948||95.0|-0.81|0.76|||t-test, 2 sided|||||0.76|-0.81|0.948
71024002|NCT00408876|141555425|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.55||||0.096||95.0|-1.2|0.1|||t-test, 2 sided|||||0.10|-1.20|0.096
71024003|NCT00408876|141555425|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||0.239||95.0|-1.05|0.26|||t-test, 2 sided|||||0.26|-1.05|0.239
71024004|NCT00408876|141555425|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53||||0.196||95.0|-1.32|0.27|||t-test, 2 sided|||||0.27|-1.32|0.196
71024005|NCT00408876|141555425|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.37||||0.367||95.0|-1.17|0.43|||t-test, 2 sided|||||0.43|-1.17|0.367
71024006|NCT00408876|141555425|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.637||95.0|-0.5|0.82|||t-test, 2 sided|||||0.82|-0.50|0.637
71024007|NCT00408876|141555426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.887||95.0|-0.76|0.65|||t-test, 2 sided|||||0.65|-0.76|0.887
71024008|NCT00408876|141555426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.81||||0.006||95.0|-1.4|-0.23|||t-test, 2 sided|||||-0.23|-1.40|0.006
71024009|NCT00408876|141555426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26||||0.392||95.0|-0.84|0.33|||t-test, 2 sided|||||0.33|-0.84|0.392
71024010|NCT00408876|141555426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.76||||0.036||95.0|-1.48|-0.05|||t-test, 2 sided|||||-0.05|-1.48|0.036
71024011|NCT00408876|141555426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.573||95.0|-0.92|0.51|||t-test, 2 sided|||||0.51|-0.92|0.573
71024012|NCT00408876|141555426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56||||0.064||95.0|-0.03|1.15|||t-test, 2 sided|||||1.15|-0.03|0.064
71024013|NCT00408876|141555427|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.374||95.0|-1.15|0.43|||t-test, 2 sided|||||0.43|-1.15|0.374
71024014|NCT00408876|141555427|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.007||95.0|-1.55|-0.25|||t-test, 2 sided|||||-0.25|-1.55|0.007
71024015|NCT00408876|141555427|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.46||||0.169||95.0|-1.12|0.2|||t-test, 2 sided|||||0.20|-1.12|0.169
71024016|NCT00408876|141555427|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.54||||0.182||95.0|-1.35|0.26|||t-test, 2 sided|||||0.26|-1.35|0.182
71024017|NCT00408876|141555427|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.802||95.0|-0.91|0.7|||t-test, 2 sided|||||0.70|-0.91|0.802
71024018|NCT00408876|141555427|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.44||||0.191||95.0|-0.22|1.11|||t-test, 2 sided|||||1.11|-0.22|0.191
71024019|NCT00408876|141555428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.556||95.0|-1.1|0.59|||t-test, 2 sided|||||0.59|-1.10|0.556
71024020|NCT00408876|141555428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.73||||0.041||95.0|-1.42|-0.03|||t-test, 2 sided|||||-0.03|-1.42|0.041
71024021|NCT00408876|141555428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.22||95.0|-1.14|0.26|||t-test, 2 sided|||||0.26|-1.14|0.220
71024022|NCT00408876|141555428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.278||95.0|-1.33|0.38|||t-test, 2 sided|||||0.38|-1.33|0.278
71024023|NCT00408876|141555428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.673||95.0|-1.04|0.68|||t-test, 2 sided|||||0.68|-1.04|0.673
71024024|NCT00408876|141555428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.29||||0.422||95.0|-0.42|1.0|||t-test, 2 sided|||||1.00|-0.42|0.422
71024025|NCT00408876|141555429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||0.234||95.0|-1.03|0.25|||t-test, 2 sided|||||0.25|-1.03|0.234
71024026|NCT00408876|141555429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.93|||<|0.001||95.0|-1.46|-0.4|||t-test, 2 sided|||||-0.40|-1.46|<0.001
71024027|NCT00408876|141555429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34||||0.213||95.0|-0.87|0.2|||t-test, 2 sided|||||0.20|-0.87|0.213
71024028|NCT00408876|141555429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.54||||0.105||95.0|-1.19|0.11|||t-test, 2 sided|||||0.11|-1.19|0.105
71024029|NCT00408876|141555429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.876||95.0|-0.6|0.7|||t-test, 2 sided|||||0.70|-0.60|0.876
71024030|NCT00408876|141555429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.59||||0.033||95.0|0.05|1.13|||t-test, 2 sided|||||1.13|0.05|0.033
71108007|NCT02949011|141721547|SUPERIORITY||Median Difference|-24.1||||0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.0001
71024031|NCT00408876|141555430|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.925||95.0|-0.73|0.8|||t-test, 2 sided|||||0.80|-0.73|0.925
71024032|NCT00408876|141555430|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.85||||0.008||95.0|-1.49|-0.22|||t-test, 2 sided|||||-0.22|-1.49|0.008
71024033|NCT00408876|141555430|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49||||0.132||95.0|-1.12|0.15|||t-test, 2 sided|||||0.15|-1.12|0.132
71024034|NCT00408876|141555430|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.89||||0.024||95.0|-1.67|-0.12|||t-test, 2 sided|||||-0.12|-1.67|0.024
71024035|NCT00408876|141555430|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52||||0.184||95.0|-1.3|0.25|||t-test, 2 sided|||||0.25|-1.30|0.184
71024036|NCT00408876|141555430|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37||||0.262||95.0|-0.27|1.01|||t-test, 2 sided|||||1.01|-0.27|0.262
71024037|NCT00408876|141555431|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.849||95.0|-0.84|0.69|||t-test, 2 sided|||||0.69|-0.84|0.849
71024038|NCT00408876|141555431|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.73||||0.024||95.0|-1.36|-0.1|||t-test, 2 sided|||||-0.10|-1.36|0.024
70934491|NCT02678455|141369777|SUPERIORITY||Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.205|0.121|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Leukocytosis||0.121|-0.205|
71024039|NCT00408876|141555431|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.773||95.0|-0.73|0.54|||t-test, 2 sided|||||0.54|-0.73|0.773
71024040|NCT00408876|141555431|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.66||||0.097||95.0|-1.43|0.12|||t-test, 2 sided|||||0.12|-1.43|0.097
71024041|NCT00408876|141555431|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.96||95.0|-0.79|0.75|||t-test, 2 sided|||||0.75|-0.79|0.960
71024042|NCT00408876|141555431|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.64||||0.052||95.0|0.0|1.28|||t-test, 2 sided|||||1.28|0.00|0.052
71024043|NCT00408876|141555432|SUPERIORITY_OR_OTHER|||||||0.756||95.0|||||Repeated Measures|||||||0.756
71024044|NCT00408876|141555432|SUPERIORITY_OR_OTHER|||||||0.507||95.0|||||Repeated Measures|||||||0.507
71024045|NCT00408876|141555432|SUPERIORITY_OR_OTHER|||||||0.056||95.0|||||Repeated Measures|||||||0.056
71024046|NCT00408876|141555432|SUPERIORITY_OR_OTHER|||||||0.816||95.0|||||Repeated Measures|||||||0.816
71024047|NCT00408876|141555432|SUPERIORITY_OR_OTHER|||||||0.208||95.0|||||Repeated Measures|||||||0.208
71024048|NCT00408876|141555432|SUPERIORITY_OR_OTHER|||||||0.212||95.0|||||Repeated Measures|||||||0.212
71024049|NCT00408876|141555433|SUPERIORITY_OR_OTHER|||||||0.885||95.0|||||Repeated Measures|||||||0.885
71024050|NCT00408876|141555433|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Repeated Measures|||||||0.026
71024051|NCT00408876|141555433|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Repeated Measures|||||||0.007
71024052|NCT00408876|141555433|SUPERIORITY_OR_OTHER|||||||0.095||95.0|||||Repeated Measures|||||||0.095
71024053|NCT00408876|141555433|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Repeated Measures|||||||0.040
71024054|NCT00408876|141555433|SUPERIORITY_OR_OTHER|||||||0.635||95.0|||||Repeated Measures|||||||0.635
71024055|NCT00408876|141555434|SUPERIORITY_OR_OTHER|||||||0.575||95.0|||||Repeated Measures|||||||0.575
71024056|NCT00408876|141555434|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Repeated Measures|||||||0.009
71024057|NCT00408876|141555434|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Repeated Measures|||||||<0.001
71024058|NCT00408876|141555434|SUPERIORITY_OR_OTHER|||||||0.115||95.0|||||Repeated Measures|||||||0.115
71024059|NCT00408876|141555434|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Repeated Measures|||||||0.002
71024060|NCT00408876|141555434|SUPERIORITY_OR_OTHER|||||||0.072||95.0|||||Repeated Measures|||||||0.072
71024061|NCT00408876|141555435|SUPERIORITY_OR_OTHER|||||||0.516||95.0|||||Repeated Measures|||||||0.516
71024062|NCT00408876|141555435|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Repeated Measures|||||||0.006
71108008|NCT02949011|141721547|SUPERIORITY||Median Difference|1.5||||0.9237||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.9237
71108009|NCT02949011|141721548|SUPERIORITY||Median Difference|-19.8|||<|0.0001|TWO_SIDED|95.0|-28.8|-12.5||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||-12.5|-28.8|<0.0001
71108010|NCT02949011|141721548|SUPERIORITY||Median Difference|-3.5||||0.2425|TWO_SIDED|95.0|-9.1|2.7||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||2.7|-9.1|0.2425
71108011|NCT02949011|141721549|SUPERIORITY|||||||0.1713||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||12 hours||||0.1713
71108012|NCT02949011|141721549|SUPERIORITY|||||||0.2249||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||12 hours||||0.2249
71108013|NCT02949011|141721549|SUPERIORITY|||||||0.0387||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||24 hours||||0.0387
71108014|NCT02949011|141721549|SUPERIORITY|||||||0.3915||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||24 hours||||0.3915
71108015|NCT02949011|141721549|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||36 hours||||<0.0001
71108016|NCT02949011|141721549|SUPERIORITY|||||||0.2617||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||36 hours||||0.2617
71108017|NCT02949011|141721549|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||48 hours||||<0.0001
71108018|NCT02949011|141721549|SUPERIORITY|||||||0.8808||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||48 hours||||0.8808
71108019|NCT02949011|141721549|SUPERIORITY|||||||0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||72 hours||||0.0001
71024063|NCT00408876|141555435|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Repeated Measures|||||||<0.001
71024064|NCT00408876|141555435|SUPERIORITY_OR_OTHER|||||||0.112||95.0|||||Repeated Measures|||||||0.112
71024065|NCT00408876|141555435|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Repeated Measures|||||||0.010
71024066|NCT00408876|141555435|SUPERIORITY_OR_OTHER|||||||0.219||95.0|||||Repeated Measures|||||||0.219
71024067|NCT00408876|141555436|SUPERIORITY_OR_OTHER|||||||0.309||95.0|||||Repeated Measures|||||||0.309
71024068|NCT00408876|141555436|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Repeated Measures|||||||0.001
71024069|NCT00408876|141555436|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Repeated Measures|||||||<0.001
71024070|NCT00408876|141555436|SUPERIORITY_OR_OTHER|||||||0.116||95.0|||||Repeated Measures|||||||0.116
71024071|NCT00408876|141555436|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Repeated Measures|||||||0.033
71024072|NCT00408876|141555436|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Repeated Measures|||||||0.480
71024073|NCT00408876|141555437|SUPERIORITY_OR_OTHER|||||||0.709||95.0|||||Repeated Measures|||||||0.709
71024074|NCT00408876|141555437|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Repeated Measures|||||||0.012
71024075|NCT00408876|141555437|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Repeated Measures|||||||0.001
71024076|NCT00408876|141555437|SUPERIORITY_OR_OTHER|||||||0.097||95.0|||||Repeated Measures|||||||0.097
71024077|NCT00408876|141555437|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||Repeated Measures|||||||0.023
71024078|NCT00408876|141555437|SUPERIORITY_OR_OTHER|||||||0.435||95.0|||||Repeated Measures|||||||0.435
71024079|NCT00408876|141555438|SUPERIORITY_OR_OTHER|||||||0.931||95.0|||||Repeated Measures|||||||0.931
71024080|NCT00408876|141555438|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Repeated Measures|||||||0.007
71024081|NCT00408876|141555438|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Repeated Measures|||||||<0.001
71024082|NCT00408876|141555438|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||Repeated Measures|||||||0.036
71024083|NCT00408876|141555438|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Repeated Measures|||||||0.007
71024084|NCT00408876|141555438|SUPERIORITY_OR_OTHER|||||||0.416||95.0|||||Repeated Measures|||||||0.416
71024085|NCT00408876|141555439|SUPERIORITY_OR_OTHER|||||||0.634||95.0|||||Repeated Measures|||||||0.634
71024086|NCT00408876|141555439|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Repeated Measures|||||||0.031
71024087|NCT00408876|141555439|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Repeated Measures|||||||0.002
71024088|NCT00408876|141555439|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Repeated Measures|||||||0.026
71024089|NCT00408876|141555439|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Repeated Measures|||||||0.003
71024090|NCT00408876|141555439|SUPERIORITY_OR_OTHER|||||||0.313||95.0|||||Repeated Measures|||||||0.313
71024091|NCT00408876|141555440|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||Repeated Measures|||||||0.910
71024092|NCT00408876|141555440|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Repeated Measures|||||||0.026
70934492|NCT02678455|141369777|SUPERIORITY||Risk Difference (RD)|0.024|||||TWO_SIDED|95.0|-0.127|0.111|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|PTT Prolonged||0.111|-0.127|
70934493|NCT02678455|141369777|SUPERIORITY||Risk Difference (RD)|0.056|||||TWO_SIDED|95.0|0.022|0.134|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Thrombocytopenia||0.134|0.022|
71024093|NCT00408876|141555440|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Repeated Measures|||||||<0.001
71024094|NCT00408876|141555440|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Repeated Measures|||||||0.090
71024095|NCT00408876|141555440|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Repeated Measures|||||||0.006
71024096|NCT00408876|141555440|SUPERIORITY_OR_OTHER|||||||0.171||95.0|||||Repeated Measures|||||||0.171
71024097|NCT00408876|141555441|SUPERIORITY_OR_OTHER|||||||0.733||95.0|||||Repeated Measures|||||||0.733
71024098|NCT00408876|141555441|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Repeated Measures|||||||0.022
71024099|NCT00408876|141555441|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Repeated Measures|||||||<0.001
71024100|NCT00408876|141555441|SUPERIORITY_OR_OTHER|||||||0.128||95.0|||||Repeated Measures|||||||0.128
71024101|NCT00408876|141555441|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||Repeated Measures|||||||0.013
71024102|NCT00408876|141555441|SUPERIORITY_OR_OTHER|||||||0.225||95.0|||||Repeated Measures|||||||0.225
71024103|NCT00408876|141555442|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Repeated Measures|||||||0.890
71024104|NCT00408876|141555442|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||Repeated Measures|||||||0.079
71024105|NCT00408876|141555442|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Repeated Measures|||||||0.035
71024106|NCT00408876|141555442|SUPERIORITY_OR_OTHER|||||||0.117||95.0|||||Repeated Measures|||||||0.117
71024107|NCT00408876|141555442|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Repeated Measures|||||||0.060
71024108|NCT00408876|141555442|SUPERIORITY_OR_OTHER|||||||0.647||95.0|||||Repeated Measures|||||||0.647
71024109|NCT00408876|141555443|SUPERIORITY_OR_OTHER|||||||0.243||95.0|||||Repeated Measures|||||||0.243
71024110|NCT00408876|141555443|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Repeated Measures|||||||0.110
71024111|NCT00408876|141555443|SUPERIORITY_OR_OTHER|||||||0.236||95.0|||||Repeated Measures|||||||0.236
71024112|NCT00408876|141555443|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Repeated Measures|||||||0.014
71024113|NCT00408876|141555443|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||Repeated Measures|||||||0.036
71024114|NCT00408876|141555443|SUPERIORITY_OR_OTHER|||||||0.756||95.0|||||Repeated Measures|||||||0.756
71024115|NCT00408876|141555444|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.23||||0.465||95.0|-0.84|0.39|||t-test, 2 sided|||||0.39|-0.84|0.465
71024116|NCT00408876|141555444|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.79||||0.002||95.0|-1.3|-0.29|||t-test, 2 sided|||||-0.29|-1.30|0.002
71024117|NCT00408876|141555444|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31||||0.233||95.0|-0.82|0.2|||t-test, 2 sided|||||0.20|-0.82|0.233
71024118|NCT00408876|141555444|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56||||0.075||95.0|-1.19|0.06|||t-test, 2 sided|||||0.06|-1.19|0.075
71024119|NCT00408876|141555444|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.798||95.0|-0.71|0.54|||t-test, 2 sided|||||0.54|-0.71|0.798
71024120|NCT00408876|141555444|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.48||||0.066||95.0|-0.03|1.0|||t-test, 2 sided|||||1.00|-0.03|0.066
71024121|NCT00408876|141555445|SUPERIORITY_OR_OTHER|||||||0.869||95.0|||||Fisher Exact|||||||0.869
71024122|NCT00408876|141555445|SUPERIORITY_OR_OTHER|||||||0.141||95.0|||||Fisher Exact|||||||0.141
71024123|NCT00408876|141555445|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Fisher Exact|||||||0.033
71024124|NCT00408876|141555445|SUPERIORITY_OR_OTHER|||||||0.142||95.0|||||Fisher Exact|||||||0.142
71024125|NCT00408876|141555445|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||Fisher Exact|||||||0.049
71024126|NCT00408876|141555445|SUPERIORITY_OR_OTHER|||||||0.587||95.0|||||Fisher Exact|||||||0.587
71024127|NCT00408876|141555446|SUPERIORITY_OR_OTHER|||||||0.356||95.0|||||Fisher Exact|||||||0.356
71024128|NCT00408876|141555446|SUPERIORITY_OR_OTHER|||||||0.472||95.0|||||Fisher Exact|||||||0.472
71024129|NCT00408876|141555446|SUPERIORITY_OR_OTHER|||||||0.255||95.0|||||Fisher Exact|||||||0.255
71024130|NCT00408876|141555446|SUPERIORITY_OR_OTHER|||||||0.107||95.0|||||Fisher Exact|||||||0.107
71024131|NCT00408876|141555446|SUPERIORITY_OR_OTHER|||||||0.053||95.0|||||Fisher Exact|||||||0.053
71024132|NCT00408876|141555446|SUPERIORITY_OR_OTHER|||||||0.779||95.0|||||Fisher Exact|||||||0.779
71024133|NCT00408876|141555447|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21||||0.747||95.0|-1.47|1.06|||t-test, 2 sided|||||1.06|-1.47|0.747
71024134|NCT00408876|141555447|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.07||||0.045||95.0|-2.12|-0.02|||t-test, 2 sided|||||-0.02|-2.12|0.045
71024135|NCT00408876|141555447|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.58||95.0|-0.76|1.36|||t-test, 2 sided|||||1.36|-0.76|0.580
71024136|NCT00408876|141555447|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.86||||0.185||95.0|-2.14|0.41|||t-test, 2 sided|||||0.41|-2.14|0.185
71024137|NCT00408876|141555447|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.51||||0.438||95.0|-0.77|1.79|||t-test, 2 sided|||||1.79|-0.77|0.438
71024138|NCT00408876|141555447|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.37||||0.012||95.0|0.3|2.44|||t-test, 2 sided|||||2.44|0.30|0.012
71024139|NCT00408876|141555448|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46||||0.729||95.0|-2.16|3.08|||t-test, 2 sided|||||3.08|-2.16|0.729
71024140|NCT00408876|141555448|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.02||||0.352||95.0|-1.14|3.18|||t-test, 2 sided|||||3.18|-1.14|0.352
71024141|NCT00408876|141555448|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.81||||0.465||95.0|-3.0|1.37|||t-test, 2 sided|||||1.37|-3.00|0.465
71024142|NCT00408876|141555448|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56||||0.677||95.0|-2.09|3.21|||t-test, 2 sided|||||3.21|-2.09|0.677
71024143|NCT00408876|141555448|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.27||||0.345||95.0|-3.92|1.38|||t-test, 2 sided|||||1.38|-3.92|0.345
71024144|NCT00408876|141555448|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.84||||0.102||95.0|-4.04|0.37|||t-test, 2 sided|||||0.37|-4.04|0.102
71024145|NCT00408876|141555449|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.977||95.0|-2.91|2.83|||t-test, 2 sided|||||2.83|-2.91|0.977
71024146|NCT00408876|141555449|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9||||0.451||95.0|-1.44|3.24|||t-test, 2 sided|||||3.24|-1.44|0.451
71024147|NCT00408876|141555449|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.74||||0.15||95.0|-0.63|4.11|||t-test, 2 sided|||||4.11|-0.63|0.150
71024148|NCT00408876|141555449|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.94||||0.524||95.0|-1.96|3.83|||t-test, 2 sided|||||3.83|-1.96|0.524
71024149|NCT00408876|141555449|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.78||||0.23||95.0|-1.13|4.69|||t-test, 2 sided|||||4.69|-1.13|0.230
71024150|NCT00408876|141555449|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.84||||0.491||95.0|-1.55|3.23|||t-test, 2 sided|||||3.23|-1.55|0.491
70934494|NCT02678455|141369777|SUPERIORITY||Risk Difference (RD)|0.051|||||TWO_SIDED|95.0|0.018|0.118|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Fever||0.118|0.018|
71024151|NCT00408876|141555450|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15||||0.645||95.0|-0.49|0.79|||t-test, 2 sided|||||0.79|-0.49|0.645
71024152|NCT00408876|141555450|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.027||95.0|0.07|1.12|||t-test, 2 sided|||||1.12|0.07|0.027
71024153|NCT00408876|141555450|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.75||||0.006||95.0|0.22|1.29|||t-test, 2 sided|||||1.29|0.22|0.006
71024154|NCT00408876|141555450|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.44||||0.18||95.0|-0.21|1.1|||t-test, 2 sided|||||1.10|-0.21|0.180
71024155|NCT00408876|141555450|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.069||95.0|-0.05|1.25|||t-test, 2 sided|||||1.25|-0.05|0.069
71024156|NCT00408876|141555450|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.564||95.0|-0.38|0.7|||t-test, 2 sided|||||0.70|-0.38|0.564
71024157|NCT00408876|141555451|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.929||95.0|-0.92|1.0|||t-test, 2 sided|||||1.00|-0.92|0.929
71024158|NCT00408876|141555451|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58||||0.147||95.0|-0.21|1.36|||t-test, 2 sided|||||1.36|-0.21|0.147
71024159|NCT00408876|141555451|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.7||95.0|-0.64|0.95|||t-test, 2 sided|||||0.95|-0.64|0.700
71024160|NCT00408876|141555451|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.54||||0.279||95.0|-0.44|1.51|||t-test, 2 sided|||||1.51|-0.44|0.279
71024161|NCT00408876|141555451|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.822||95.0|-0.86|1.09|||t-test, 2 sided|||||1.09|-0.86|0.822
71024162|NCT00408876|141555451|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42||||0.299||95.0|-1.22|0.38|||t-test, 2 sided|||||0.38|-1.22|0.299
71024163|NCT00408876|141555452|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.766||95.0|-1.33|0.98|||t-test, 2 sided|||||0.98|-1.33|0.766
71024164|NCT00408876|141555452|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.217||95.0|-0.35|1.55|||t-test, 2 sided|||||1.55|-0.35|0.217
71024165|NCT00408876|141555452|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.88||95.0|-0.89|1.04|||t-test, 2 sided|||||1.04|-0.89|0.880
71024166|NCT00408876|141555452|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.78||||0.193||95.0|-0.39|1.94|||t-test, 2 sided|||||1.94|-0.39|0.193
71024167|NCT00408876|141555452|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25||||0.675||95.0|-0.92|1.42|||t-test, 2 sided|||||1.42|-0.92|0.675
71024168|NCT00408876|141555452|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53||||0.288||95.0|-1.5|0.45|||t-test, 2 sided|||||0.45|-1.50|0.288
71024169|NCT00408876|141555453|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42||||0.501||95.0|-1.66|0.81|||t-test, 2 sided|||||0.81|-1.66|0.501
71024170|NCT00408876|141555453|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33||||0.524||95.0|-0.69|1.35|||t-test, 2 sided|||||1.35|-0.69|0.524
71024171|NCT00408876|141555453|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.89||||0.089||95.0|-0.14|1.91|||t-test, 2 sided|||||1.91|-0.14|0.089
71024172|NCT00408876|141555453|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.75||||0.234||95.0|-0.49|2.0|||t-test, 2 sided|||||2.00|-0.49|0.234
71024173|NCT00408876|141555453|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.31||||0.04||95.0|0.06|2.56|||t-test, 2 sided|||||2.56|0.06|0.040
71024174|NCT00408876|141555453|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56||||0.289||95.0|-0.48|1.59|||t-test, 2 sided|||||1.59|-0.48|0.289
71024175|NCT00408876|141555454|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.862||95.0|-0.27|0.32|||t-test, 2 sided|||||0.32|-0.27|0.862
71024176|NCT00408876|141555454|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.368||95.0|-0.13|0.35|||t-test, 2 sided|||||0.35|-0.13|0.368
71024177|NCT00408876|141555454|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06||||0.628||95.0|-0.18|0.31|||t-test, 2 sided|||||0.31|-0.18|0.628
71024178|NCT00408876|141555454|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.573||95.0|-0.21|0.38|||t-test, 2 sided|||||0.38|-0.21|0.573
71024179|NCT00408876|141555454|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.819||95.0|-0.26|0.33|||t-test, 2 sided|||||0.33|-0.26|0.819
70934495|NCT02678455|141369777|SUPERIORITY||Risk Difference (RD)|-0.036|||||TWO_SIDED|95.0|-0.203|0.089|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Headache||0.089|-0.203|
70934496|NCT02678455|141369777|SUPERIORITY||Risk Difference (RD)|0.166|||||TWO_SIDED|95.0|0.016|0.275|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Rash||0.275|0.016|
71108020|NCT02949011|141721549|SUPERIORITY|||||||0.5923||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||72 hours||||0.5923
71108021|NCT02949011|141721549|SUPERIORITY|||||||0.0064||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||96 hours||||0.0064
71108022|NCT02949011|141721549|SUPERIORITY|||||||0.6746||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||96 hours||||0.6746
71108023|NCT02949011|141721549|SUPERIORITY|||||||0.8167||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||120 hours||||0.8167
71108024|NCT02949011|141721549|SUPERIORITY|||||||0.3773||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||120 hours||||0.3773
70934497|NCT02678455|141369777|SUPERIORITY||Risk Difference (RD)|0.063|||||TWO_SIDED|95.0|0.03|0.126|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Arthralgia||0.126|0.030|
70934498|NCT02678455|141369777|SUPERIORITY||Risk Difference (RD)|0.023|||||TWO_SIDED|95.0|-0.155|0.118|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Fatigue||0.118|-0.155|
70934499|NCT02678455|141369777|SUPERIORITY||Risk Difference (RD)|0.041|||||TWO_SIDED|95.0|-0.105|0.105|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Myalgia||0.105|-0.105|
70934500|NCT02678455|141369777|SUPERIORITY||Risk Difference (RD)|0.019|||||TWO_SIDED|95.0|-0.16|0.114|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Nausea||0.114|-0.160|
70934501|NCT02678455|141369777|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.216|0.141|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Photophobia||0.141|-0.216|
70934502|NCT02678455|141369777|SUPERIORITY||Risk Difference (RD)|0.024|||||TWO_SIDED|95.0|-0.142|0.088|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Retro-orbital Pain||0.088|-0.142|
71024180|NCT00408876|141555454|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.687||95.0|-0.3|0.2|||t-test, 2 sided|||||0.20|-0.30|0.687
71024181|NCT00408876|141555455|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.972||95.0|-0.48|0.5|||t-test, 2 sided|||||0.50|-0.48|0.972
71024182|NCT00408876|141555455|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.99||95.0|-0.4|0.4|||t-test, 2 sided|||||0.40|-0.40|0.990
71024183|NCT00408876|141555455|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.793||95.0|-0.35|0.46|||t-test, 2 sided|||||0.46|-0.35|0.793
71024184|NCT00408876|141555455|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.981||95.0|-0.5|0.49|||t-test, 2 sided|||||0.49|-0.50|0.981
71024185|NCT00408876|141555455|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.857||95.0|-0.45|0.54|||t-test, 2 sided|||||0.54|-0.45|0.857
71024186|NCT00408876|141555455|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.805||95.0|-0.36|0.46|||t-test, 2 sided|||||0.46|-0.36|0.805
71024187|NCT00408876|141555456|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24||||0.34||95.0|-0.26|0.75|||t-test, 2 sided|||||0.75|-0.26|0.340
71024188|NCT00408876|141555456|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.848||95.0|-0.45|0.37|||t-test, 2 sided|||||0.37|-0.45|0.848
71024189|NCT00408876|141555456|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.573||95.0|-0.54|0.3|||t-test, 2 sided|||||0.30|-0.54|0.573
71024190|NCT00408876|141555456|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29||||0.272||95.0|-0.79|0.22|||t-test, 2 sided|||||0.22|-0.79|0.272
71024191|NCT00408876|141555456|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.161||95.0|-0.88|0.15|||t-test, 2 sided|||||0.15|-0.88|0.161
71024192|NCT00408876|141555456|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.711||95.0|-0.5|0.34|||t-test, 2 sided|||||0.34|-0.50|0.711
71024193|NCT00408876|141555457|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.713||95.0|-1.39|0.95|||t-test, 2 sided|||||0.95|-1.39|0.713
71024194|NCT00408876|141555457|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.52||||0.288||95.0|-0.44|1.49|||t-test, 2 sided|||||1.49|-0.44|0.288
71024195|NCT00408876|141555457|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.46||||0.351||95.0|-1.44|0.51|||t-test, 2 sided|||||0.51|-1.44|0.351
71024196|NCT00408876|141555457|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74||||0.219||95.0|-0.44|1.93|||t-test, 2 sided|||||1.93|-0.44|0.219
71024197|NCT00408876|141555457|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24||||0.686||95.0|-1.43|0.94|||t-test, 2 sided|||||0.94|-1.43|0.686
71024198|NCT00408876|141555457|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.98||||0.05||95.0|-1.97|0.0|||t-test, 2 sided|||||0.00|-1.97|0.050
71024199|NCT00408876|141555458|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.663||95.0|-0.06|0.04|||t-test, 2 sided|||||0.04|-0.06|0.663
71024200|NCT00408876|141555458|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.33||95.0|-0.02|0.06|||t-test, 2 sided|||||0.06|-0.02|0.330
71024201|NCT00408876|141555458|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.143||95.0|-0.01|0.07|||t-test, 2 sided|||||0.07|-0.01|0.143
71024202|NCT00408876|141555458|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.218||95.0|-0.02|0.08|||t-test, 2 sided|||||0.08|-0.02|0.218
71024203|NCT00408876|141555458|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.1||95.0|-0.01|0.09|||t-test, 2 sided|||||0.09|-0.01|0.100
71024204|NCT00408876|141555458|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.614||95.0|-0.03|0.05|||t-test, 2 sided|||||0.05|-0.03|0.614
71024205|NCT00408876|141555459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.786||95.0|-1.83|1.39|||t-test, 2 sided|||||1.39|-1.83|0.786
71024206|NCT00408876|141555459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52||||0.445||95.0|-1.85|0.81|||t-test, 2 sided|||||0.81|-1.85|0.445
71024207|NCT00408876|141555459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.39||||0.043||95.0|0.04|2.74|||t-test, 2 sided|||||2.74|0.04|0.043
71024208|NCT00408876|141555459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.721||95.0|-1.92|1.33|||t-test, 2 sided|||||1.33|-1.92|0.721
71024209|NCT00408876|141555459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.61||||0.053||95.0|-0.02|3.24|||t-test, 2 sided|||||3.24|-0.02|0.053
70934503|NCT02678455|141369777|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.216|0.141|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Decrease in Activity||0.141|-0.216|
70934504|NCT02678455|141369777|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.216|0.141|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Loss of Appetite||0.141|-0.216|
70934505|NCT02678455|141369777|SUPERIORITY||Risk Difference (RD)|0.083|||||TWO_SIDED|95.0|-0.165|0.218|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Vomiting||0.218|-0.165|
71024210|NCT00408876|141555459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.91||||0.006||95.0|0.54|3.27|||t-test, 2 sided|||||3.27|0.54|0.006
71024211|NCT00408876|141555460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.378||95.0|-0.48|1.25|||t-test, 2 sided|||||1.25|-0.48|0.378
71024212|NCT00408876|141555460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.723||95.0|-0.84|0.59|||t-test, 2 sided|||||0.59|-0.84|0.723
71024213|NCT00408876|141555460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.542||95.0|-0.95|0.5|||t-test, 2 sided|||||0.50|-0.95|0.542
71024214|NCT00408876|141555460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52||||0.245||95.0|-1.39|0.36|||t-test, 2 sided|||||0.36|-1.39|0.245
71108025|NCT02949011|141721549|SUPERIORITY|||||||0.1041||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||144 hours||||0.1041
70934506|NCT02678455|141369778|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|83.0|||||TWO_SIDED|95.0|76.0|88.0||||||All study participants seropositive to DENV-1 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||88|76|
70934507|NCT02678455|141369778|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|99.0|||||TWO_SIDED|95.0|96.0|100.0||||||All study participants seropositive to DENV-2 post TV005 Vaccination. There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|96|
71024215|NCT00408876|141555460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.61||||0.169||95.0|-1.48|0.26|||t-test, 2 sided|||||0.26|-1.48|0.169
71024216|NCT00408876|141555460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.796||95.0|-0.82|0.63|||t-test, 2 sided|||||0.63|-0.82|0.796
71024217|NCT00408876|141555462|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71024218|NCT00408876|141555462|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||t-test, 2 sided|||||||0.015
71024219|NCT00408876|141555462|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||t-test, 2 sided|||||||0.015
71024220|NCT00408876|141555463|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||t-test, 2 sided|||||||0.039
71024221|NCT00408876|141555464|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||t-test, 2 sided|||||||0.048
71024222|NCT00408876|141555465|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||t-test, 2 sided|||||||0.015
71024223|NCT00408876|141555465|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||t-test, 2 sided|||||||0.046
71024224|NCT00408876|141555466|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||t-test, 2 sided|||||||0.039
71024225|NCT00408876|141555467|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||t-test, 2 sided|||||||0.042
71024226|NCT00408876|141555468|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71024227|NCT00408876|141555469|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||t-test, 2 sided|||||||0.031
71024228|NCT00408876|141555470|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||t-test, 2 sided|||||||0.030
71024229|NCT00408876|141555471|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||||||0.005
71024230|NCT00408876|141555471|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71024231|NCT00408876|141555471|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||||||0.001
71024232|NCT00408876|141555472|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.38||||0.348||95.0|-4.28|1.51|||t-test, 2 sided|||||1.51|-4.28|0.348
71024233|NCT00408876|141555472|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5||||0.04||95.0|0.11|4.89|||t-test, 2 sided|||||4.89|0.11|0.040
71024234|NCT00408876|141555472|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.61||||0.191||95.0|-0.81|4.03|||t-test, 2 sided|||||4.03|-0.81|0.191
71024235|NCT00408876|141555472|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.89||||0.009||95.0|0.97|6.8|||t-test, 2 sided|||||6.80|0.97|0.009
71024236|NCT00408876|141555472|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.0||||0.044||95.0|0.08|5.91|||t-test, 2 sided|||||5.91|0.08|0.044
71024237|NCT00408876|141555472|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.89||||0.473||95.0|-3.33|1.55|||t-test, 2 sided|||||1.55|-3.33|0.473
71024238|NCT00408876|141555473|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.846||95.0|-3.61|4.4|||t-test, 2 sided|||||4.40|-3.61|0.846
71024239|NCT00408876|141555473|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.934||95.0|-3.45|3.17|||t-test, 2 sided|||||3.17|-3.45|0.934
71024240|NCT00408876|141555473|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.03||||0.234||95.0|-1.32|5.39|||t-test, 2 sided|||||5.39|-1.32|0.234
71024241|NCT00408876|141555473|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.54||||0.794||95.0|-4.58|3.5|||t-test, 2 sided|||||3.50|-4.58|0.794
71024242|NCT00408876|141555473|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.64||||0.426||95.0|-2.4|5.67|||t-test, 2 sided|||||5.67|-2.40|0.426
71024243|NCT00408876|141555473|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.17||||0.207||95.0|-1.21|5.55|||t-test, 2 sided|||||5.55|-1.21|0.207
71024244|NCT00408876|141555474|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.901||95.0|-2.54|2.89|||t-test, 2 sided|||||2.89|-2.54|0.901
71024245|NCT00408876|141555474|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.926||95.0|-2.35|2.14|||t-test, 2 sided|||||2.14|-2.35|0.926
71024246|NCT00408876|141555474|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.62||||0.002||95.0|1.35|5.9|||t-test, 2 sided|||||5.90|1.35|0.002
71024247|NCT00408876|141555474|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28||||0.841||95.0|-3.02|2.46|||t-test, 2 sided|||||2.46|-3.02|0.841
71024248|NCT00408876|141555474|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.45||||0.014||95.0|0.71|6.19|||t-test, 2 sided|||||6.19|0.71|0.014
71024249|NCT00408876|141555474|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.73||||0.001||95.0|1.44|6.02|||t-test, 2 sided|||||6.02|1.44|0.001
71024250|NCT00408876|141555475|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.057||95.0|-1.41|0.02|||t-test, 2 sided|||||0.02|-1.41|0.057
71024251|NCT00408876|141555475|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.46||||0.128||95.0|-1.05|0.13|||t-test, 2 sided|||||0.13|-1.05|0.128
71024252|NCT00408876|141555475|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.82||||0.007||95.0|-1.42|-0.22|||t-test, 2 sided|||||-0.22|-1.42|0.007
70934508|NCT02678455|141369778|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm|percentage seropositive|96.0|||||TWO_SIDED|95.0|92.0|98.0||||||All study participants seropositive to DENV-3 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||98|92|
71024253|NCT00408876|141555475|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24||||0.518||95.0|-0.48|0.96|||t-test, 2 sided|||||0.96|-0.48|0.518
71024254|NCT00408876|141555475|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.734||95.0|-0.85|0.6|||t-test, 2 sided|||||0.60|-0.85|0.734
71024255|NCT00408876|141555475|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.239||95.0|-0.97|0.24|||t-test, 2 sided|||||0.24|-0.97|0.239
71024256|NCT01488019|141555485|NON_INFERIORITY|The hazard ratio and 90% two-sided confidence interval for the hazard ratio comparing Perforomist to placebo were estimated. Non-inferiority was declared if the upper limit of the two-sided 90% confidence interval was wholly less than 1.5.|Hazard Ratio (HR)|0.965|||||TWO_SIDED|90.0|0.711|1.308||Hazard Ratio was calculated as Perforomist vs Placebo. The non-inferiority margin for the hazard ratio is 1.5. Subjects with no primary event at withdrawal or study completion were treated as censored observations at time of withdrawal|Regression, Cox|Treatment, site group, and bronchodilator reversibility included as covariates in the model.|Hazard Ratio was calculated as Perforomist Inhalation Solution vs Placebo. The non-inferiority margin for the hazard ratio is 1.5.|||1.308|0.711|
71024257|NCT02400710|141555499|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||ANOVA|||||||.05
70934509|NCT02678455|141369778|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|87.0|||||TWO_SIDED|95.0|81.0|92.0||||||All study participants seropositive to DENV-4 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||92|81|
71024258|NCT02400710|141555500|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Chi-squared|||||||.05
71024259|NCT04147715|141555511|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of S-648414 were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.9913|||||TWO_SIDED|90.0|0.9232|1.0645|||||Ratio = S-648414 + Dolutegravir / S-648414|The effect of dolutegravir on the PK of S-648414 was assessed by analysis of variance (ANOVA) fit with a linear mixed effect model with the natural log (ln)-transformed Cmax as the dependent variable, treatment as fixed effect, and participant as random effect. The difference and 90% confidence interval (CI) between the ln-transformed Cmax of S-648414 + dolutegravir and S-648414 alone were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0645|0.9232|
71024260|NCT04147715|141555511|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of S-648414 were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.9754|||||TWO_SIDED|90.0|0.8916|1.0671|||||Ratio = S-648414 + Dolutegravir / S-648414|The effect of dolutegravir on the PK of S-648414 was assessed by an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cmax as the dependent variable, treatment as fixed effect, and participant as random effect. The difference and 90% CI between the ln-transformed Cmax of S-648414 + dolutegravir and S-648414 alone were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0671|0.8916|
71024261|NCT04147715|141555513|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of S-648414 were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.0353|||||TWO_SIDED|90.0|0.9421|1.1377|||||Ratio = S-648414 + Dolutegravir / S-648414|The effect of dolutegravir on the PK of S-648414 was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cτ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cτ of S-648414 + dolutegravir and S-648414 alone were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.1377|0.9421|
71024262|NCT04147715|141555513|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of S-648414 were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.9096|||||TWO_SIDED|90.0|0.8791|0.9411|||||Ratio = S-648414 + Dolutegravir / S-648414|The effect of dolutegravir on the PK of S-648414 was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cτ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cτ of S-648414 + dolutegravir and S-648414 alone were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||0.9411|0.8791|
71024263|NCT04147715|141555514|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of S-648414 were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.0071|||||TWO_SIDED|90.0|0.9679|1.0479|||||Ratio = S-648414 + Dolutegravir / S-648414|The effect of dolutegravir on the PK of S-648414 was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed AUC0-τ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-τ of S-648414 + dolutegravir and S-648414 alone were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0479|0.9679|
71024264|NCT04147715|141555514|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of S-648414 were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.9852|||||TWO_SIDED|90.0|0.9605|1.0105|||||Ratio = S-648414 + Dolutegravir / S-648414|The effect of dolutegravir on the PK of S-648414 was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed AUC0-τ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-τ of S-648414 + dolutegravir and S-648414 alone were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0105|0.9605|
71024265|NCT04147715|141555516|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of dolutegravir were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.1806|||||TWO_SIDED|90.0|1.1171|1.2477|||||Ratio = S-648414 + Dolutegravir / Dolutegravir|The effect of S-648414 on the plasma PK of dolutegravir was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cmax as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cmax of dolutegravir plus S-648414 and dolutegravir alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.2477|1.1171|
71024266|NCT04147715|141555516|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of dolutegravir were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.048|||||TWO_SIDED|90.0|0.9656|1.1373|||||Ratio = S-648414 + Dolutegravir / Dolutegravir|The effect of S-648414 on the plasma PK of dolutegravir was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cmax as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cmax of dolutegravir plus S-648414 and dolutegravir alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.1373|0.9656|
71024267|NCT04147715|141555518|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of dolutegravir were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.3445|||||TWO_SIDED|90.0|1.2352|1.4636|||||Ratio = S-648414 + Dolutegravir / Dolutegravir|The effect of S-648414 on the plasma PK of dolutegravir was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cτ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cτ of dolutegravir plus S-648414 and dolutegravir alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.4636|1.2352|
71024268|NCT04147715|141555518|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of dolutegravir were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.0769|||||TWO_SIDED|90.0|1.0137|1.1441|||||Ratio = S-648414 + Dolutegravir / Dolutegravir|The effect of S-648414 on the plasma PK of dolutegravir was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cτ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cτ of dolutegravir plus S-648414 and dolutegravir alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.1441|1.0137|
71024269|NCT04147715|141555519|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of dolutegravir were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.1939|||||TWO_SIDED|90.0|1.1176|1.2754|||||Ratio = S-648414 + Dolutegravir / Dolutegravir|The effect of S-648414 on the plasma PK of dolutegravir was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed AUC0-τ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-τ of dolutegravir plus S-648414 and dolutegravir alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.2754|1.1176|
71024270|NCT04147715|141555519|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of dolutegravir were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.0482|||||TWO_SIDED|90.0|0.9881|1.1119|||||Ratio = S-648414 + Dolutegravir / Dolutegravir|The effect of S-648414 on the plasma PK of dolutegravir was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed AUC0-τ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-τ of dolutegravir plus S-648414 and dolutegravir alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.1119|0.9881|
71024271|NCT04147715|141555521|OTHER||Slope|0.9857|||||TWO_SIDED|95.0|0.9341|1.0373||||||The dose proportionality of plasma PK parameters of S-648414 was examined for all fasted groups in Part 1 using the power model. The power model assumes a linear relationship between the ln-transformed parameter and ln-transformed dose where ln(Cmax) = Intercept + Slope × ln(Dose) + Random error||1.0373|0.9341|
71024272|NCT04147715|141555521|OTHER||Geometric Least Squares Mean Ratio|0.8786|||||TWO_SIDED|90.0|0.7705|1.0019|||||Ratio = Fed / Fasted|"The effect of food on the plasma PK of S-648414 was examined after a single dose of 100 mg S-648414 in the fed state and fasted state using an ANOVA fitted with a linear mixed effect model with ln-transformed Cmax as the dependent variable, treatment as a fixed effect, and participant as random effect.~The difference and 90% CI between the fed and fasted state ln-transformed Cmax were estimated, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||1.0019|0.7705|
71024273|NCT04147715|141555523|OTHER||Slope|1.0252|||||TWO_SIDED|95.0|0.984|1.0665||||||The dose proportionality of plasma PK parameters of S-648414 was examined for all fasted groups in Part 1 using the power model. The power model assumes a linear relationship between the ln-transformed parameter and ln-transformed dose where ln(AUC0-last) = Intercept + Slope × ln(Dose) + Random error||1.0665|0.9840|
71108026|NCT02949011|141721549|SUPERIORITY|||||||0.3328||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||144 hours||||0.3328
71024274|NCT04147715|141555523|OTHER||Geometric Least Squares Mean Ratio|0.9598|||||TWO_SIDED|90.0|0.8585|1.073|||||Ratio = Fed / Fasted|The effect of food on the plasma PK of S-648414 was examined after a single dose of 100 mg S-648414 in the fed and fasted state using an ANOVA fitted with a linear mixed effect model, with ln-transformed AUC0-last as the dependent variable, treatment as a fixed effect, and participant as random effect. The difference and 90% CI between the fed and fasted state ln-transformed AUC0-last were estimated, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0730|0.8585|
71024275|NCT04147715|141555524|OTHER||Slope|1.028|||||TWO_SIDED|95.0|0.9866|1.0695||||||The dose proportionality of plasma PK parameters of S-648414 was examined for all fasted groups in Part 1 using the power model. The power model assumes a linear relationship between the ln-transformed parameter and ln-transformed dose where ln(AUC0-inf) = Intercept + Slope × ln(Dose) + Random error||1.0695|0.9866|
71024276|NCT04147715|141555524|OTHER||Geometric Least Squares Mean Ratio|0.9646|||||TWO_SIDED|90.0|0.8643|1.0766|||||Ratio = Fed / Fasted|The effect of food on the plasma PK of S-648414 was examined after a single dose of 100 mg S-648414 in the fed and fasted state using an ANOVA fitted with a linear mixed effect model, with ln-transformed AUC0-inf as the dependent variable, treatment as a fixed effect, and participant as random effect. The difference and 90% CI between the fed and fasted state ln-transformed AUC0-inf were estimated, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0766|0.8643|
71024277|NCT04147715|141555525|OTHER||Geometric Least Squares Mean Ratio|1.0272|||||TWO_SIDED|90.0|0.9949|1.0606|||||Ratio = Fed / Fasted|The effect of food on the plasma PK of S-648414 was examined after a single dose of 100 mg S-648414 in the fed and fasted state using an ANOVA fitted with a linear mixed effect model, with ln-transformed t1/2,z as the dependent variable, treatment as a fixed effect, and participant as random effect. The difference and 90% CI between the fed and fasted state ln-transformed t1/2,z were estimated, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0606|0.9949|
71024278|NCT04147715|141555532|OTHER||Geometric Least Squares Mean Ratio|1.5167|||||TWO_SIDED|90.0|1.2654|1.818|||||Ratio = 50 mg / 30 mg|"The dose proportionality of plasma S-648414 Cmax after a single dose of S-648414 (Day 1) was assessed using an ANOVA model fitted to the ln-transformed Cmax, with dose group fitted as a fixed factor.~The point estimates and 90% CIs were generated for the ratios of the 50 mg dose to 30 mg dose ln-transformed Cmax, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||1.8180|1.2654|
71024279|NCT04147715|141555532|OTHER||Geometric Least Squares Mean Ratio|1.8372|||||TWO_SIDED|90.0|1.5696|2.1506|||||Ratio = 50 mg / 30 mg|"The dose proportionality of plasma S-648414 Cmax after multiple doses of S-648414 (Day 14) was assessed using an ANOVA model fitted to the ln-transformed Cmax, with dose group fitted as a fixed factor.~The point estimates and 90% CIs were generated for the ratios of the 50 mg dose to 30 mg dose ln-transformed Cmax, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||2.1506|1.5696|
71024280|NCT04147715|141555532|OTHER||Geometric Least Squares Mean Ratio|1.7489|||||TWO_SIDED|90.0|1.525|2.0057|||||Ratio = Day 14 / Day 1|"The accumulation ratio of Cmax in the 30 mg dose group was calculated as the ratio of Day 14 to Day 1 using an ANOVA fitted with a linear mixed model with ln-transformed Cmax, Day as a fixed effect and participant as a random effect.~The difference and 90% CI between the ln-transformed Cmax on Day 1 and Day 14 were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||2.0057|1.5250|
71024281|NCT04147715|141555532|OTHER||Geometric Least Squares Mean Ratio|2.1453|||||TWO_SIDED|90.0|1.9741|2.3313|||||Ratio = Day 14 / Day 1|"The accumulation ratio of Cmax in the 50 mg dose group was calculated as the ratio of Day 14 to Day 1 using an ANOVA fitted with a linear mixed model with ln-transformed Cmax, Day as a fixed effect and participant as a random effect.~The difference and 90% CI between the ln-transformed Cmax on Day 1 and Day 14 were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||2.3313|1.9741|
71024282|NCT04147715|141555534|OTHER||Geometric Least Squares Mean Ratio|1.6277|||||TWO_SIDED|90.0|1.4038|1.8874|||||Ratio = 50 mg / 30 mg|"The dose proportionality of plasma S-648414 AUC0-τ after a single dose of S-648414 (Day 1) was assessed using an ANOVA model fitted to the ln-transformed AUC0-τ, with dose group fitted as a fixed factor.~The point estimates and 90% CIs were generated for the ratios of the 50 mg dose to 30 mg dose ln-transformed AUC0-τ, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||1.8874|1.4038|
71024283|NCT04147715|141555534|OTHER||Geometric Least Squares Mean Ratio|1.7454|||||TWO_SIDED|90.0|1.4785|2.0605|||||Ratio = 50 mg / 30 mg|"The dose proportionality of plasma S-648414 AUC0-τ after multiple doses of S-648414 (Day 14) was assessed using an ANOVA model fitted to the ln-transformed AUC0-τ, with dose group fitted as a fixed factor.~The point estimates and 90% CIs were generated for the ratios of the 50 mg dose to 30 mg dose ln-transformed AUC0-τ, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||2.0605|1.4785|
71024284|NCT04147715|141555534|OTHER||Geometric Least Squares Mean Ratio|1.9102|||||TWO_SIDED|90.0|1.7788|2.0513|||||Ratio = Day 14 / Day 1|"The accumulation ratio of AUC0-τ in the 30 mg dose group was calculated as the ratio of Day 14 to Day 1 using an ANOVA fitted with a linear mixed model with ln-transformed AUC0-τ, Day as a fixed effect and participant as a random effect.~The difference and 90% CI between the ln-transformed AUC0-τ on Day 1 and Day 14 were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||2.0513|1.7788|
71024285|NCT04147715|141555534|OTHER||Geometric Least Squares Mean Ratio|2.0478|||||TWO_SIDED|90.0|1.9203|2.1837|||||Ratio = Day 14 / Day 1|"The accumulation ratio of AUC0-τ in the 50 mg dose group was calculated as the ratio of Day 14 to Day 1 using an ANOVA fitted with a linear mixed model with ln-transformed AUC0-τ, Day as a fixed effect and participant as a random effect.~The difference and 90% CI between the ln-transformed AUC0-τ on Day 1 and Day 14 were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||2.1837|1.9203|
71024286|NCT04147715|141555541|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, AUC0-last, and AUC0-inf of midazolam were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.9241|||||TWO_SIDED|90.0|0.8057|1.06|||||Ratio = 30 mg S-648414 + Midazolam / Midazolam|The effect of S-648414 on the PK of midazolam (a CYP3A substrate) was assessed using an ANOVA fitted with a linear mixed effect model with ln-transformed Cmax as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cmax of midazolam plus S-648414 and midazolam alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratios and 90% CIs.||1.0600|0.8057|
71024287|NCT04147715|141555541|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, AUC0-last, and AUC0-inf of midazolam were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.0303|||||TWO_SIDED|90.0|0.9299|1.1415|||||Ratio = 50 mg S-648414 + Midazolam / Midazolam|The effect of S-648414 on the PK of midazolam (a CYP3A substrate) was assessed using an ANOVA fitted with a linear mixed effect model with ln-transformed Cmax as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cmax of midazolam plus S-648414 and midazolam alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratios and 90% CIs.||1.1415|0.9299|
71024288|NCT04147715|141555543|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, AUC0-last, and AUC0-inf of midazolam were completely contained within the range of 0.8000 to 1.2500|Geometric Least Squares Mean Ratio|0.842|||||TWO_SIDED|90.0|0.6628|1.0696|||||Ratio = 30 mg S-648414 + Midazolam / Midazolam|The effect of S-648414 on the PK of midazolam (a CYP3A substrate) was assessed using an ANOVA fitted with a linear mixed effect model with ln-transformed AUC0-last as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-last of midazolam plus S-648414 and midazolam alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratios and 90% CIs.||1.0696|0.6628|
71024289|NCT04147715|141555543|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, AUC0-last, and AUC0-inf of midazolam were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.8542|||||TWO_SIDED|90.0|0.7185|1.0155|||||Ratio = 50 mg S-648414 + Midazolam / Midazolam|The effect of S-648414 on the PK of midazolam (a CYP3A substrate) was assessed using an ANOVA fitted with a linear mixed effect model with ln-transformed AUC0-last as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-last of midazolam plus S-648414 and midazolam alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratios and 90% CIs.||1.0155|0.7185|
71024290|NCT04147715|141555544|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, AUC0-last, and AUC0-inf of midazolam were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.8377|||||TWO_SIDED|90.0|0.6645|1.0561|||||Ratio = 30 mg S-648414 + Midazolam / Midazolam|The effect of S-648414 on the PK of midazolam (a CYP3A substrate) was assessed using an ANOVA fitted with a linear mixed effect model with ln-transformed AUC0-inf as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-inf of midazolam plus S-648414 and midazolam alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratios and 90% CIs.||1.0561|0.6645|
71024291|NCT04147715|141555544|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, AUC0-last, and AUC0-inf of midazolam were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.8529|||||TWO_SIDED|90.0|0.7213|1.0085|||||Ratio = 50 mg S-648414 + Midazolam / Midazolam|The effect of S-648414 on the PK of midazolam (a CYP3A substrate) was assessed using an ANOVA fitted with a linear mixed effect model with ln-transformed AUC0-inf as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-inf of midazolam plus S-648414 and midazolam alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratios and 90% CIs.||1.0085|0.7213|
71024292|NCT02629965|141555562|SUPERIORITY||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.019|<|0.001|TWO_SIDED|95.0|0.077|0.153|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.153|0.077|<0.001
71024293|NCT02629965|141555563|SUPERIORITY||Mean Difference (Final Values)|4.168|STANDARD_ERROR_OF_MEAN|5.26||0.4291|TWO_SIDED|95.0|-6.211|14.548|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|14.548|-6.211|0.4291
71024294|NCT02629965|141555564|SUPERIORITY||Mean Difference (Final Values)|9.501|STANDARD_ERROR_OF_MEAN|83.704||0.9098|TWO_SIDED|95.0|-155.692|174.694|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|174.694|-155.692|0.9098
71057112|NCT03597464|141619111|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|1.39||||0.29|TWO_SIDED|95.0|0.75|2.58|||Regression, Logistic|||Month 36||2.58|0.75|0.290
71057113|NCT03597464|141619112|OTHER||Odds Ratio (OR)|0.56||||0.045|TWO_SIDED|95.0|0.32|0.99|||Regression, Logistic|||Number of subjects with adequate renal response. This model is based on a logistic regression with terms for treatment, baseline urine protein creatinine ratio (UPCR), biopsy class, mycophenolate mofetil (MMF) use at baseline and region. An odds ratio \< unity indicates benefit for voclosporin.||0.99|0.32|0.045
71057114|NCT03597464|141619113|SUPERIORITY||Least Squares Mean difference|-0.8||||0.238|TWO_SIDED|95.0|-2.1|0.5|||Mixed Models Analysis|||Month 18||0.5|-2.1|0.238
71057115|NCT03597464|141619113|SUPERIORITY||Least Squares Mean difference|-0.7||||0.215|TWO_SIDED|95.0|-1.8|0.4|||Mixed Models Analysis|||Month 24||0.4|-1.8|0.215
71024295|NCT02629965|141555565|SUPERIORITY||Mean Difference (Final Values)|-0.292|STANDARD_ERROR_OF_MEAN|0.469||0.5338|TWO_SIDED|95.0|-1.217|0.633|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.633|-1.217|0.5338
71024296|NCT02629965|141555566|SUPERIORITY||Mean Difference (Final Values)|0.939|STANDARD_ERROR_OF_MEAN|1.007||0.3524|TWO_SIDED|95.0|-1.048|2.926|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|2.926|-1.048|0.3524
70934510|NCT02678455|141369778|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|86.0|||||TWO_SIDED|95.0|71.0|94.0||||||Adult study participants seropositive to DENV-1 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
71024297|NCT02629965|141555567|SUPERIORITY||Mean Difference (Final Values)|2.257|STANDARD_ERROR_OF_MEAN|2.647||0.3949|TWO_SIDED|95.0|-2.966|7.481|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|7.481|-2.966|0.3949
71024298|NCT02629965|141555568|SUPERIORITY||Mean Difference (Final Values)|2.42|STANDARD_ERROR_OF_MEAN|3.543||0.4955|TWO_SIDED|95.0|-4.572|9.411|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|9.411|-4.572|0.4955
71024299|NCT02629965|141555569|SUPERIORITY||Mean Difference (Final Values)|0.134|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.091|0.176|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.176|0.091|<0.0001
71024300|NCT02629965|141555570|SUPERIORITY||Mean Difference (Final Values)|0.105|STANDARD_ERROR_OF_MEAN|0.009|<|0.0001|TWO_SIDED|95.0|0.088|0.123|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.123|0.088|<0.0001
71024301|NCT02629965|141555571|SUPERIORITY||Mean Difference (Final Values)|0.163|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.13|0.197|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.197|0.130|<0.0001
71057116|NCT03597464|141619113|SUPERIORITY||Least Squares Mean difference|-0.7||||0.246|TWO_SIDED|95.0|-1.8|0.5|||Mixed Models Analysis|||Month 36||0.5|-1.8|0.246
71057117|NCT03597464|141619114|SUPERIORITY||Least Squares Mean difference|-0.65||||0.001|TWO_SIDED|95.0|-1.05|-0.26|||Mixed Models Analysis|||Month 12 (AURORA 2 baseline)||-0.26|-1.05|0.001
70934511|NCT02678455|141369778|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adult study participants seropositive to DENV-2 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
71057118|NCT03597464|141619114|SUPERIORITY||Least Squares Mean difference|-0.63||||0.029|TWO_SIDED|95.0|-1.2|-0.07|||Mixed Models Analysis|||Month 18||-0.07|-1.20|0.029
71057119|NCT03597464|141619114|SUPERIORITY||Least Squares Mean difference|-0.77||||0.002|TWO_SIDED|95.0|-1.24|-0.29|||Mixed Models Analysis|||Month 24||-0.29|-1.24|0.002
71057120|NCT03597464|141619114|SUPERIORITY||Least Squares Mean difference|-0.91||||0.002|TWO_SIDED|95.0|-1.49|-0.33|||Mixed Models Analysis|||Month 30||-0.33|-1.49|0.002
71057121|NCT03597464|141619114|SUPERIORITY||Least Squares Mean difference|-0.48||||0.106|TWO_SIDED|95.0|-1.06|-0.1|||Mixed Models Analysis|||Month 36||-0.10|-1.06|0.106
71024302|NCT02629965|141555572|SUPERIORITY||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.103|0.162|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.162|0.103|<0.0001
71024303|NCT02629965|141555573|SUPERIORITY||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.1|0.156|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.156|0.100|<0.0001
71024304|NCT02629965|141555574|SUPERIORITY||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.056|0.108|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.108|0.056|<0.0001
71024305|NCT02629965|141555575|SUPERIORITY||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.058|0.114|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.114|0.058|<0.0001
71024306|NCT02629965|141555576|SUPERIORITY||Mean Difference (Final Values)|0.083|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.059|0.108|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.108|0.059|<0.0001
71024307|NCT02629965|141555577|SUPERIORITY||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.114|0.189|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.189|0.114|<0.0001
71024308|NCT00905489|141555578|SUPERIORITY_OR_OTHER||Ratio NVP XR: NVP IR (%)|91.2|STANDARD_ERROR_OF_MEAN|1.05||0.008|TWO_SIDED|90.0|83.47|99.64|||Mixed Models Analysis|Adjusted geometric means are estimated from the mixed model for intra-individual comparison.||||99.64|83.47|0.0080
71024309|NCT00895583|141555602|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.239|TWO_SIDED|95.0|0.4|1.3||Two-sided alpha equals (=) 0.05.|Fisher Exact|||||1.3|0.4|0.239
71024310|NCT00895583|141555603|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.422|TWO_SIDED|95.0|0.5|1.4||Alpha was unadjusted.|Fisher Exact|||||1.4|0.5|0.422
71024311|NCT00895583|141555604|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.524|TWO_SIDED|95.0|0.5|1.4||Alpha was unadjusted.|Fisher Exact|||Month 12||1.4|0.5|0.524
71024312|NCT00895583|141555604|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.298|TWO_SIDED|95.0|0.4|1.2||Alpha was unadjusted.|Fisher Exact|||Month 24||1.2|0.4|0.298
71024313|NCT00895583|141555605|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||0.055|TWO_SIDED|95.0|0.3|1.0||Alpha was unadjusted.|Fisher Exact|||Month 12||1.0|0.3|0.055
71024314|NCT00895583|141555605|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.33|TWO_SIDED|95.0|0.4|1.3||Alpha was unadjusted.|Fisher Exact|||Month 24||1.3|0.4|0.330
71024315|NCT00895583|141555606|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.543|TWO_SIDED|95.0|0.4|1.5||Alpha was unadjusted.|Fisher Exact|||Month 12||1.5|0.4|0.543
70851712|NCT01818752|141191320|SUPERIORITY_OR_OTHER||Least squares mean difference|4.99|STANDARD_ERROR_OF_MEAN|0.773|<|0.0001|TWO_SIDED|95.0|3.48|6.51||Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.|Mixed Effects Model for Repeated Measure|||Treatment groups were compared using a linear mixed model for repeated measures (MMRM). The model included the fixed, categorical effects of treatment (all baseline responses were modeled with a dummy treatment), the randomization stratification factors - ISS stage, choice of route of bortezomib administration, region, age, and random effects of subject intercept and coefficient on time.||6.51|3.48|< 0.0001
70934512|NCT02678455|141369778|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adult study participants seropositive to DENV-3 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
71024316|NCT00895583|141555606|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.6|1.8||Alpha was unadjusted.|Fisher Exact|||Month 24||1.8|0.6|1.000
71024317|NCT00895583|141555608|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|1.3||0.019|TWO_SIDED|95.0|0.5|5.5||Alpha was unadjusted.|ANCOVA|Analysis of covariance (ANCOVA) with treatment as a factor and baseline GFR as a covariate.||Change from randomization at Month 6||5.5|0.5|0.019
71024318|NCT00895583|141555608|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.5||0.215|TWO_SIDED|95.0|-4.8|1.1||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline GFR as a covariate.||Change from randomization at Month 12||1.1|-4.8|0.215
71024319|NCT00895583|141555608|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.7||0.722|TWO_SIDED|95.0|-2.7|3.9||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline GFR as a covariate.||Change from randomization at Month 18||3.9|-2.7|0.722
71024320|NCT00895583|141555608|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.9||0.71|TWO_SIDED|95.0|-3.0|4.4||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline GFR as a covariate.||Change from randomization at Month 24||4.4|-3.0|0.710
71024321|NCT00895583|141555609|SUPERIORITY_OR_OTHER||Slope difference (SRL-TAC)|-1.8||||0.131|TWO_SIDED|95.0|-4.2|0.5|||Random coefficient model||Random coefficient model with GFR as the dependent variable and study day as the independent variable.|Slope difference (sirolimus \[SRL\] minus tacrolimus \[TAC\])||0.5|-4.2|0.131
71024322|NCT00895583|141555611|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|2.4||0.105|TWO_SIDED|95.0|-8.6|0.8||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline serum creatinine as a covariate.||Change from randomization at Month 6||0.8|-8.6|0.105
71024323|NCT00895583|141555611|SUPERIORITY_OR_OTHER||LS Mean Difference|7.7|STANDARD_ERROR_OF_MEAN|3.3||0.023|TWO_SIDED|95.0|1.1|14.3||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline serum creatinine as a covariate.||Change from randomization at Month 12||14.3|1.1|0.023
70934513|NCT02678455|141369778|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|91.0|||||TWO_SIDED|95.0|78.0|97.0||||||Adult study participants seropositive to DENV-4 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
71024324|NCT00895583|141555611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|3.4||0.955|TWO_SIDED|95.0|-6.8|6.4||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline serum creatinine as a covariate.||Change from randomization at Month 18||6.4|-6.8|0.955
71057122|NCT03597464|141619115|SUPERIORITY||Least Squares Mean difference|-2.7||||0.041|TWO_SIDED|95.0|-5.3|-0.1|||Mixed Models Analysis|||Month 12 (AURORA 2 baseline)||-0.1|-5.3|0.041
71024325|NCT00895583|141555611|SUPERIORITY_OR_OTHER||LS Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|5.8||0.582|TWO_SIDED|95.0|-8.2|14.6||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline serum creatinine as a covariate.||Change from randomization at Month 24||14.6|-8.2|0.582
71024326|NCT00895583|141555612|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||||||0.006
71024327|NCT00895583|141555613|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Post-randomization to Month 12 Post-transplantation||||1.000
71057123|NCT03597464|141619115|SUPERIORITY||Least Squares Mean difference|-1.8||||0.292|TWO_SIDED|95.0|-5.1|1.6|||Mixed Models Analysis|||Month 18||1.6|-5.1|0.292
71024328|NCT00895583|141555613|SUPERIORITY_OR_OTHER|||||||0.215|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Post-randomization to Month 24 post-transplantation||||0.215
71024329|NCT00895583|141555614|SUPERIORITY_OR_OTHER|||||||0.499|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Month 6||||0.499
71024330|NCT00895583|141555614|SUPERIORITY_OR_OTHER|||||||0.067|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Month 12||||0.067
71057124|NCT03597464|141619115|SUPERIORITY||Least Squares Mean difference|-2.2||||0.282|TWO_SIDED|95.0|-6.1|1.8|||Mixed Models Analysis|||Month 24||1.8|-6.1|0.282
71057125|NCT03597464|141619115|SUPERIORITY||Least Squares Mean difference|0.9||||0.659|TWO_SIDED|95.0|-3.2|5.1|||Mixed Models Analysis|||Month 30||5.1|-3.2|0.659
71024331|NCT00895583|141555614|SUPERIORITY_OR_OTHER|||||||0.061|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Month 18||||0.061
71024332|NCT00895583|141555614|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Month 24||||0.020
71024333|NCT00895583|141555617|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||On-therapy Period||||1.000
71024334|NCT00895583|141555617|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Off-therapy Period||||1.000
71024335|NCT00895583|141555618|SUPERIORITY_OR_OTHER|||||||0.284|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Baseline||||0.284
71024336|NCT00895583|141555618|SUPERIORITY_OR_OTHER|||||||0.046|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Month 12||||0.046
71024337|NCT00895583|141555618|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Month 24||||1.000
71057126|NCT03597464|141619115|SUPERIORITY||Least Squares Mean difference|1.8||||0.438|TWO_SIDED|95.0|-2.8|6.4|||Mixed Models Analysis|||Month 36||6.4|-2.8|0.438
71024338|NCT00895583|141555619|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.81|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||TC, Month 12||||<0.001
70934514|NCT02678455|141369778|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|83.0|||||TWO_SIDED|95.0|67.0|92.0||||||Adolescent study participants seropositive to DENV-1 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||92|67|
71024339|NCT00895583|141555619|SUPERIORITY_OR_OTHER||Difference in Adjusted Mean|0.61|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||TC, Month 24||||<0.001
71024340|NCT00895583|141555619|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.824|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||HDL-C, Month 12||||0.824
71024341|NCT00895583|141555619|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.735|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||HDL-C, Month 24||||0.735
71024342|NCT00895583|141555619|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.49|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||LDL-C, Month 12||||<0.001
71024343|NCT00895583|141555619|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.42|STANDARD_ERROR_OF_MEAN|0.13||0.001|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||LDL-C, Month 24||||0.001
71024344|NCT00895583|141555619|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.65|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||Triglycerides, Month 12||||<0.001
71024345|NCT00895583|141555619|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.37|STANDARD_ERROR_OF_MEAN|0.16||0.028|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||Triglycerides, Month 24||||0.028
71024346|NCT00895583|141555620|SUPERIORITY_OR_OTHER|||||||0.429|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Anti-hypertensives, Baseline||||0.429
71024347|NCT00895583|141555620|SUPERIORITY_OR_OTHER|||||||0.326|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Anti-hypertensives, Month 12||||0.326
71024348|NCT00895583|141555620|SUPERIORITY_OR_OTHER|||||||0.517|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Anti-hypertensives, Month 24||||0.517
71024349|NCT00895583|141555620|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Diabetes agents (insulin), Baseline||||1.000
71024350|NCT00895583|141555620|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Diabetes agent (insulin), Month 12||||1.000
71024351|NCT00895583|141555620|SUPERIORITY_OR_OTHER|||||||0.223|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Diabetes agent (insulin), Month 24||||0.223
71024352|NCT00895583|141555620|SUPERIORITY_OR_OTHER|||||||0.498|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Diabetes agent (non-insulin), Baseline||||0.498
71024353|NCT00895583|141555620|SUPERIORITY_OR_OTHER|||||||0.566|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Diabetes agent (non-insulin), Month 12||||0.566
71024354|NCT00895583|141555620|SUPERIORITY_OR_OTHER|||||||0.423|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Diabetes agent (non-insulin), Month 24||||0.423
71024355|NCT00895583|141555620|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Lipid-lowering agents, Baseline||||0.033
71024356|NCT00895583|141555620|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Lipid-lowering agents, Month 12||||0.900
71024357|NCT00895583|141555620|SUPERIORITY_OR_OTHER|||||||0.802|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Lipid-lowering agents, Month 24||||0.802
71024358|NCT00895583|141555620|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||ESAs, Baseline||||0.260
71024359|NCT00895583|141555620|SUPERIORITY_OR_OTHER|||||||0.086|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||ESAs, Month 12||||0.086
71024360|NCT00895583|141555620|SUPERIORITY_OR_OTHER|||||||0.723|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||ESAs, Month 24||||0.723
71024361|NCT00895583|141555621|SUPERIORITY_OR_OTHER||Treatment Ratio|1.71|||<|0.001|TWO_SIDED|95.0|1.38|2.11||Alpha was unadjusted.|ANCOVA|ANCOVA model with change in the logarithmic Upr/Cr as dependent variable, treatment and logarithmic pre-randomization value as covariate.||Change from pre-randomization at Month 12; treatment ratio (SRC/TAC) in adjusted geometric mean fold-change from baseline.||2.11|1.38|<0.001
71024362|NCT00895583|141555621|SUPERIORITY_OR_OTHER||Treatment Ratio|1.77|||<|0.001|TWO_SIDED|95.0|1.39|2.26||Alpha was unadjusted.|ANCOVA|ANCOVA model with change in the logarithmic Upr/Cr as dependent variable, treatment and logarithmic pre-randomization value as covariate.||Change from pre-randomization at Month 24; treatment ratio (SRC/TAC) in adjusted geometric mean fold-change from baseline.||2.26|1.39|<0.001
71024363|NCT00895583|141555622|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Pre-randomization||||1.000
71024364|NCT00895583|141555622|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||On-Therapy Period||||0.020
71024365|NCT00895583|141555622|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Off-Therapy Period||||0.021
71024366|NCT00895583|141555623|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Alpha is unadjusted.|Fisher Exact|||||||<0.001
71024367|NCT00895583|141555624|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||On-Therapy Period, any treatment||||<0.001
71024368|NCT00895583|141555624|SUPERIORITY_OR_OTHER|||||||0.685|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Off-Therapy Period, any treatment||||0.685
70934515|NCT02678455|141369778|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|100.0|||||TWO_SIDED|95.0|90.0|100.0||||||Adolescent study participants seropositive to DENV-2 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|90|
70934516|NCT02678455|141369778|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adolescent study participants seropositive to DENV-3 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
70934517|NCT02678455|141369778|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|86.0|||||TWO_SIDED|95.0|71.0|94.0||||||Adolescent study participants seropositive to DENV-4 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
71057127|NCT03597464|141619116|SUPERIORITY||Least Squares Mean difference|-67.7||||0.002|TWO_SIDED|95.0|-110.4|-25.1|||Mixed Models Analysis|||Month 12 (AURORA 2 baseline)||-25.1|-110.4|0.002
71057128|NCT03597464|141619116|SUPERIORITY||Least Squares Mean difference|-87.7||||0.007|TWO_SIDED|95.0|-151.2|-24.2|||Mixed Models Analysis|||Month 18||-24.2|-151.2|0.007
71057129|NCT03597464|141619116|SUPERIORITY||Least Squares Mean difference|-47.0||||0.035|TWO_SIDED|95.0|-90.8|-3.3|||Mixed Models Analysis|||Month 24||-3.3|-90.8|0.035
71024369|NCT00895583|141555625|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.521|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|||||||0.521
71024370|NCT00895583|141555626|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.28|STANDARD_ERROR_OF_MEAN|0.25||0.265|TWO_SIDED|||||Alpha is unadjusted.|ANCOVA||ANCOVA with treatment as a factor and baseline as a covariate.|||||0.265
71024371|NCT00895583|141555627|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|10.02|STANDARD_ERROR_OF_MEAN|23.61||0.672|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA||ANCOVA with treatment as a factor and baseline as a covariate.|||||0.672
71057130|NCT03597464|141619116|SUPERIORITY||Least Squares Mean difference|-73.1||||0.005|TWO_SIDED|95.0|-123.5|-22.6|||Mixed Models Analysis|||Month 30||-22.6|-123.5|0.005
71057131|NCT03597464|141619116|SUPERIORITY||Least Squares Mean difference|-19.0||||0.537|TWO_SIDED|95.0|-79.7|41.7|||Mixed Models Analysis|||Month 36||41.7|-79.7|0.537
71057132|NCT03597464|141619117|SUPERIORITY||Least Squares Mean difference|0.084|||<|0.001|TWO_SIDED|95.0|0.035|0.134|||Mixed Models Analysis|||Month 12 (AURORA 2 baseline)||0.134|0.035|<0.001
71024372|NCT00895583|141555628|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.45|STANDARD_ERROR_OF_MEAN|0.67||0.504|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA||ANCOVA with treatment as a factor and baseline as a covariate.|||||0.504
71057133|NCT03597464|141619117|SUPERIORITY||Least Squares Mean difference|0.051||||0.209|TWO_SIDED|95.0|-0.029|0.131|||Mixed Models Analysis|||Month 18||0.131|-0.029|0.209
71057134|NCT03597464|141619117|SUPERIORITY||Least Squares Mean difference|0.057||||0.353|TWO_SIDED|95.0|-0.064|0.178|||Mixed Models Analysis|||Month 24||0.178|-0.064|0.353
71057135|NCT03597464|141619117|SUPERIORITY||Least Squares Mean difference|-0.036||||0.616|TWO_SIDED|95.0|-0.176|0.105|||Mixed Models Analysis|||Month 30||0.105|-0.176|0.616
71057136|NCT03597464|141619117|SUPERIORITY||Least Squares Mean difference|-0.077||||0.372|TWO_SIDED|95.0|-0.248|0.094|||Mixed Models Analysis|||Month 36||0.094|-0.248|0.372
71057137|NCT02111603|141619171|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of on-treatment total fecal bile acid excretion with baseline total fecal bile acid excretion.||||0.012
71024373|NCT00895583|141555629|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.56|STANDARD_ERROR_OF_MEAN|1.18||0.637|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||||||0.637
71024374|NCT00895583|141555630|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.08|STANDARD_ERROR_OF_MEAN|1.48||0.955|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||||||0.955
71024375|NCT00895583|141555631|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|216.29|STANDARD_ERROR_OF_MEAN|198.84||0.279|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||||||0.279
71024376|NCT00895583|141555632|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.22|STANDARD_ERROR_OF_MEAN|0.23||0.337|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|||||||0.337
71057138|NCT01753297|141619184|OTHER|||||||0.158|||||||Log Rank|||A two-sided log-rank test was used to compare time to BRFS between both treatment groups.|Analysis on BRFS was based on 61 BR events (comprised of 35 BR events in the active surveillance arm and 26 BR events in the triptorelin arm).|||0.158
71057139|NCT01753297|141619184|OTHER||Hazard Ratio (HR)|0.65||||0.1|TWO_SIDED|95.0|0.38|1.09|||Regression, Cox|||"Comparison between treatment groups: Triptorelin compared to Active surveillance.~A Cox proportional hazard model was fitted to compute hazards ratios (HRs) and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||1.09|0.38|0.100
70934518|NCT02678455|141369778|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|81.0|||||TWO_SIDED|95.0|65.0|90.0||||||Children study participants seropositive to DENV-1 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|65|
71024377|NCT00895583|141555633|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||New onset (from baseline up to On-Therapy Month 24)||||0.025
71024378|NCT00895583|141555633|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||New onset at 1 year (from baseline up to On-Therapy Month 12)||||0.012
71024379|NCT00895583|141555633|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||New onset at 2 years (from On-Therapy Month 12 to On-Therapy Month 24)||||1.000
71024380|NCT00895583|141555634|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Insulin (12-Month)||||1.000
71024381|NCT00895583|141555634|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Non-insulin (12-Month)||||1.000
71024382|NCT00895583|141555634|SUPERIORITY_OR_OTHER|||||||0.386|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Non-insulin (24-Month)||||0.386
71024383|NCT00895583|141555634|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Insulin (24-Month)||||1.000
71024384|NCT00895583|141555635|SUPERIORITY_OR_OTHER|||||||0.129|TWO_SIDED||||||Fisher Exact|||||||0.129
71024385|NCT00895583|141555636|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.000
71024386|NCT00895583|141555637|SUPERIORITY_OR_OTHER|||||||0.276|TWO_SIDED||||||Fisher Exact|||||||0.276
71024387|NCT00895583|141555638|SUPERIORITY_OR_OTHER|||||||0.158|TWO_SIDED||||||Fisher Exact|||||||0.158
71024388|NCT01191255|141555647|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The P-value for the change in mean serum phosphorus was calculated via an ANCOVA model with treatment as the fixed effect and Week-52-baseline as the co-variate.|ANCOVA|||||||<0.0001
71024389|NCT01191255|141555648|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The P-value for the change in mean serum Ferritin were created via an ANCOVA model with treatment as the fixed effect and Study-baseline as the co-variate.|ANCOVA|||||||<0.0001
71057140|NCT01753297|141619184|OTHER||Hazard Ratio (HR)|1.49||||0.502|TWO_SIDED|95.0|0.46|4.79|||Regression, Cox|||"Comparison between countries: Russia compared to China.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."|Interactions effect between treatment group and each covariate (country, centre(country) and Gleason score) were tested one by one in separate models. An interaction effect was considered as significant if p-value was \<0.20. Interaction between treatment group and country: p=0.970.|4.79|0.46|0.502
71108027|NCT02949011|141721549|SUPERIORITY|||||||0.7867||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||168 hours||||0.7867
70934519|NCT02678455|141369778|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|100.0|||||TWO_SIDED|95.0|90.0|100.0||||||Children study participants seropositive to DENV-2 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|90|
71024390|NCT01191255|141555649|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71024391|NCT01191255|141555650|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71024392|NCT01191255|141555651|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71024393|NCT02196506|141555652|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.0074|TWO_SIDED|95.0|-3.97|-0.62|||Mixed Models Analysis|||Statistical Analysis at Week 14||-0.62|-3.97|0.0074
71024394|NCT02196506|141555653|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.3331|TWO_SIDED|95.0|-0.66|0.23|||Mixed Models Analysis|||Statistical Analysis at Week 14||0.23|-0.66|0.3331
71024395|NCT02196506|141555654|SUPERIORITY||Mean Difference (Final Values)|-2.25||||0.0263|TWO_SIDED|95.0|-4.23|-0.27|||Mixed Models Analysis|||Statistical Analysis at Week 14||-0.27|-4.23|0.0263
71024396|NCT02196506|141555655|SUPERIORITY||Mean Difference (Final Values)|-2.98||||0.0099|TWO_SIDED|95.0|-5.24|-0.72|||Mixed Models Analysis|||Statistical Analysis at Week 14||-0.72|-5.24|0.0099
71024397|NCT01715415|141555656|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical SVR rates for noncirrhotic peg-interferon/ribavirin (pegIFN/RBV) treatment-experienced subjects administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 60% to achieve noninferiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV, and the LCB of the 95% CI must have exceeded 70% to achieve superiority.|Percentage of Participants with SVR12|96.3|||||TWO_SIDED|95.0|94.1|98.4|||||95% CI calculated using the normal approximation to the binomial distribution. In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure was used to proceed through the primary and numbered secondary efficacy endpoints.|With a sample size of 300 subjects and assuming that 85% of the subjects in Arm A will achieve sustained virologic response (SVR) 12, this study has greater than 90% power to demonstrate non-inferiority with a 2-sided 95% lower confidence bound greater than 60% and greater than 90% power to demonstrate superiority with a 2-sided 95% lower confidence bound greater than 70% (based on the normal approximation of a single binomial proportion).||98.4|94.1|
71024398|NCT01715415|141555657|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure will be used to proceed through the primary and the first 3 secondary endpoints in the order numbered below.|Fisher Exact|||||||<0.001
71024399|NCT01715415|141555658|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical SVR rates for noncirrhotic pegIFN/RBV treatment-experienced subjects of the appropriate HCV genotype 1 subtype administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 65% to achieve superiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV.|Percentage of Participants with SVR12|96.0|||||TWO_SIDED|95.0|93.0|98.9|||||95% CI calculated using the normal approximation to the binomial distribution.|||98.9|93.0|
70934520|NCT02678455|141369778|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|100.0|||||TWO_SIDED|95.0|90.0|100.0||||||Children study participants seropositive to DENV-3 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|90|
71024400|NCT01715415|141555659|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical SVR rates for noncirrhotic pegIFN/RBV treatment-experienced subjects of the appropriate HCV genotype 1 subtype administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 77% to achieve superiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV.|Percentage of Participants with SVR12|96.7|||||TWO_SIDED|95.0|93.6|99.9||||||||99.9|93.6|
71057141|NCT01753297|141619184|OTHER|||||||0.671|||||||Regression, Cox|||"Centre effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."|Interactions effect between treatment group and each covariate (country, centre(country) and Gleason score) were tested one by one in separate models. An interaction effect was considered as significant if p-value was \<0.20. Interaction between treatment group and centre: p=0.241.|||0.671
71057142|NCT01753297|141619184|OTHER||Hazard Ratio (HR)|2.35||||0.093|TWO_SIDED|95.0|0.87|6.39|||Regression, Cox|||"Comparison between Gleason score categories: Gleason score of =7 compared to Gleason score ≤6.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."|Interactions effect between treatment group and each covariate (country, centre(country) and Gleason score) were tested one by one in separate models. An interaction effect was considered as significant if p-value was \<0.20. Interaction between treatment group and Gleason score: p=0.272.|6.39|0.87|0.093
71108028|NCT02949011|141721549|SUPERIORITY|||||||0.864||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||168 hours||||0.8640
71108029|NCT02949011|141721549|SUPERIORITY|||||||0.6465||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||192 hours||||0.6465
71108030|NCT02949011|141721549|SUPERIORITY|||||||0.4265||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||192 hours||||0.4265
71024401|NCT03586830|141555686|SUPERIORITY||Difference of least square (LS) means|-4.56|STANDARD_ERROR_OF_MEAN|0.757|<|0.001|TWO_SIDED|95.0|-6.05|-3.06|||Hochberg Approach|||||-3.06|-6.05|<.001
71024402|NCT03586830|141555686|SUPERIORITY||Difference of LS Means|-5.85|STANDARD_ERROR_OF_MEAN|0.755|<|0.001|TWO_SIDED|95.0|-7.34|-4.36|||Hochberg Approach|||||-4.36|-7.34|<.001
71024403|NCT03586830|141555686|SUPERIORITY||Difference of LS Means|-7.23|STANDARD_ERROR_OF_MEAN|0.748|<|0.001|TWO_SIDED|95.0|-8.7|-5.75|||Hochberg Approach|||||-5.75|-8.70|<.001
71024404|NCT04578548|141555690|SUPERIORITY||Geometric Mean Difference|-0.91||||0.606|TWO_SIDED|95.0|-4.34|2.64|||Random coefficient regression model|||Based on a random coefficient regression model (linear slope model) on htTKV log-transformed values with time (in weeks) as a continuous variable, treatment, time-by-treatment interaction and a random intercept and slope. The treatment effect was determined by using estimated slopes for each treatment group on the basis of the time-by-treatment interaction term from the mixed model.||2.64|-4.34|0.606
71024405|NCT04578548|141555692|SUPERIORITY||Least-squares mean difference|-2.31||||0.171|TWO_SIDED|95.0|-5.64|1.02|||Random coefficient regression model|||Least-squares mean difference (95% CI) from a random coefficient regression model (linear slope model) on eGFR values with time (in weeks) as a continuous variable, the time-by-treatment interaction and a random intercept and slope. The treatment effect was determined by using estimated slopes for each treatment group on the basis of the time-by-treatment interaction term from the mixed model.||1.02|-5.64|0.171
71108031|NCT02949011|141721549|SUPERIORITY|||||||0.6568||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||216 hours||||0.6568
71108032|NCT02949011|141721549|SUPERIORITY|||||||0.6102||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||216 hours||||0.6102
71108033|NCT02949011|141721550|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.07||0.0408|TWO_SIDED|95.0|-0.28|-0.01||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||12 hours||-0.01|-0.28|0.0408
71108034|NCT02949011|141721550|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.5324|TWO_SIDED|95.0|-0.18|0.09||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||12 hours||0.09|-0.18|0.5324
71024406|NCT00395083|141555696|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.62|TWO_SIDED|95.0|0.7|1.8|||Log Rank|||||1.80|0.70|0.62
71024407|NCT00395083|141555697|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.62|TWO_SIDED|95.0|0.7|1.8|||Regression, Cox|||||1.80|0.70|0.62
71024408|NCT00395083|141555698|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.0||||0.003|TWO_SIDED|95.0|1.46|6.17|||Regression, Cox|||||6.17|1.46|0.003
71024409|NCT00395083|141555699|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.0||||0.002|TWO_SIDED|95.0|1.46|6.17|||Log Rank|||||6.17|1.46|0.002
71024410|NCT01133821|141555733|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||time effect for HRSD-17||||<0.0001
71024411|NCT01133821|141555734|SUPERIORITY||||||>|0.05|||||||Regression, Linear|Adjusted for baseline scores||||||>0.05
71024412|NCT00325403|141555735|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|23.0||||0.0125|TWO_SIDED|95.0|4.0|41.0||P-Value|ANCOVA|||Using an allocation ratio of 2:1 between oral treprostinil and placebo, a fixed sample size of approximately 195 subjects with access to 0.25 mg tablets at randomization would provide at least 90% power at a significance level of 0.01 (two-sided hypothesis) to detect a between-treatment difference in the change from Baseline to Week 12 in distance traversed during the 6-minute walk, assuming a true underlying treatment difference of 45 meters with a SD of 75 meters in both treatment groups.||41|4|0.0125
71024413|NCT00325403|141555736|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|13.0||||0.0653|TWO_SIDED|95.0|-2.0|33.0|||ANCOVA|||||33|-2|0.0653
71024414|NCT00325403|141555737|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|17.0||||0.0307|TWO_SIDED|95.0|1.0|33.0|||ANCOVA|||||33|1|0.0307
71024415|NCT00325403|141555738|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|12.0||||0.0518|TWO_SIDED|95.0|0.0|24.0|||ANCOVA|||||24|0|0.0518
71024416|NCT00325403|141555739|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Fisher Exact|||||||1.000
71024417|NCT00325403|141555740|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|0.0||||0.738|TWO_SIDED|95.0|0.0|0.0||"In cases where the value corresponding to overall poorest relative change was imputed for walk distance, a value of IV was used for the WHO functional classification for PAH."|Wilcoxon rank sum test||The values for the estimated parameter and 95% confidence interval were calculated.|||0|0|0.7380
71024418|NCT00325403|141555741|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|0.0||||0.4887|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||||0|-1|0.4887
71024419|NCT00325403|141555742|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|0.0||||0.6116|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon sum-rank test|||||1|0|0.6116
71024420|NCT00325403|141555744|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|26.0||||0.0326|TWO_SIDED|95.0|1.0|49.0|||ANCOVA|||||49|1|0.0326
71024421|NCT00325403|141555745|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|16.0||||0.2275|TWO_SIDED|95.0|-15.0|47.0|||ANCOVA|||||47|-15|0.2275
71057143|NCT01753297|141619184|OTHER||Hazard Ratio (HR)|2.03||||0.168|TWO_SIDED|95.0|0.74|5.55|||Regression, Cox|||"Comparison between Gleason score categories: Gleason score of ≥8 compared to Gleason score ≤6.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||5.55|0.74|0.168
71057144|NCT01753297|141619186|OTHER|||||||0.639|||||||Log Rank|||A two-sided log-rank test was used to compare time to EFS between both treatment groups.|Analysis was based on 2 EFS events in the active surveillance arm and 3 EFS events in the triptorelin arm.|||0.639
71024422|NCT00325403|141555746|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|32.0||||0.0024|TWO_SIDED|95.0|10.0|55.0|||ANCOVA|||||55|10|0.0024
71024423|NCT00325403|141555747|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|25.5||||0.0001|TWO_SIDED|95.0|10.0|41.0|||ANCOVA|||||41|10|0.0001
71108035|NCT02949011|141721550|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.06||0.0025|TWO_SIDED|95.0|-0.3|-0.06||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||24 hours||-0.06|-0.30|0.0025
71024424|NCT00325403|141555748|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|17.0||||0.0025|TWO_SIDED|95.0|3.0|33.0|||ANCOVA|||||33|3|0.0025
71024425|NCT00325403|141555749|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|20.0||||0.0008|TWO_SIDED|95.0|7.0|34.0|||ANCOVA|||||34|7|0.0008
71024426|NCT00325403|141555750|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|14.0||||0.0025|TWO_SIDED|95.0|3.9|25.0|||ANCOVA|||||25|3.9|0.0025
71024427|NCT01907087|141555781|OTHER|Inference is by an exact binomial test of the null hypothesis H0: Prob(response) \<= 0.50 vs. the alternative hypothesis H1: Prob(response) \> 0.50, where Prob(response) denotes the population probability of a response. The confidence interval is an exact interval with significance level α=0.05.|Proportion of responders|0.87||||0.0002|TWO_SIDED|95.0|0.66|0.97|||exact binomial test|||"Responder Analysis using ITT Population: Proportion of Subjects without an Unreversed Two-point Decline or Score of 0 in ML Scale Score at 48 Weeks.~A 'response' is defined as the absence of an unreversed two-point decline or score of 0 in the 0-to-6 point CLN2 score at 48 weeks."||0.97|0.66|0.0002
71024428|NCT01907087|141555781|OTHER|"Subject rate of decline per 48 weeks is estimated: (baseline CLN2 score - last CLN2 score)/(time elapsed in units of 48 weeks).~P-value computed as a two-sided t-test for the hypothesis H0: Rate=2.0 points lost/48 weeks vs. H1: Rate not equal 2.0 points lost/48 weeks."|Slope|0.4|STANDARD_DEVIATION|0.809|<|0.0001|TWO_SIDED|95.0|0.05|0.75|||t-test, 2 sided|||Slopes Analysis using ITT Population: Estimated Rate of Decline (300 mg Dosing Period).||0.75|0.05|<0.0001
71024429|NCT03273387|141555789|SUPERIORITY|||||||0.008||||||95% Confidence interval 1.97 - 11.3 statistical significant if p\<0.05|t-test, 2 sided|t=2.988 df=18||||||0.008
71024430|NCT03273387|141555790|SUPERIORITY|||||||0.33||||||statistical significant if p \<0.05|two-way ANOVA|DF=3||||||0.33
71024431|NCT03273387|141555791|SUPERIORITY|||||||0.0002||||||95% Confidence interval 15.92 to 42.53 statistical significant if p \<0.05|t-test, 2 sided|t=4.598 df=19||||||0.0002
71024432|NCT02180061|141555796|SUPERIORITY|||||||0.0216||||||One-sided p-value. The ORR was deemed clinically meaningful if the lower bound of the 95% confidence interval exceeded 10% (p\<0.0250).|Exact Binomial Distribution|||||||0.0216
71024433|NCT02410252|141555801|OTHER||%|100.0|||||TWO_SIDED|||||There was no statistical analysis conducted on demographic characteristics or baseline surveys|descriptive analysis|||Descriptive statistics were used to characterize the study sample, and survey responses.||||
71024434|NCT02410252|141555801|OTHER|Only percents were calculated, no formal statistical analysis was completed.||||||||||||Statistical analysis was not completed. This was a feasibility study with small n and was not powered to determine statistical significance.||||Only percent will be calculated. No statistical analysis will be conducted.|No statistical analysis was conducted as part of this study.|||
70934521|NCT02678455|141369778|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|78.0|||||TWO_SIDED|95.0|62.0|88.0||||||Children study participants seropositive to DENV-4 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||88|62|
71024435|NCT02410252|141555802|OTHER||%|0.29||||0.13|TWO_SIDED|||||Significance was set at p\<0.05|Cochran-Mantel-Haenszel|||"GAD-7 scores were coded as a categorical variable as follows: mild anxiety (total score 0 to 5) and moderate/ severe anxiety (total score 6-15).~Proportion of participants with mild and moderate/ severe anxiety at enrollment and closeout was compared using Cochran's Q test."||||0.13
71024436|NCT02410252|141555803|OTHER||%|84.0||||0.05|TWO_SIDED||||||descriptive analysis|||Descriptive statistics were used to characterize the study sample, and survey responses. All analysis was conducted using STATA version 14.2 with an alpha of 0.05 set a priori. Since this was an exploratory study with descriptive statistics, a complete case analysis approach was adopted for this study||||0.05
71024437|NCT01772368|141555810|OTHER|linearity statistical test|||||<|0.0001||||||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.||A linear in log-dose-trend contrast was constructed to evaluate the dose-response trend, where the logarithm of dose was defined precisely as log (dose+1) to accommodate the case of Fp MDPI 100 mcg, since the dose used in this trend analysis was the salmeterol dose. The study was considered positive if the trend test was positive and the test involving the highest FS MDPI dose (100/50 mcg) compared with Fp MDPI 100 mcg was positive, regardless of the results of the tests for the other doses.||||<0.0001
71024438|NCT01772368|141555810|SUPERIORITY||LSM difference|251.3|||<|0.0001|TWO_SIDED|95.0|215.6|287.1||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/50 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/50 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||287.1|215.6|<0.0001
71024439|NCT01772368|141555810|SUPERIORITY||LSM difference|227.56|||<|0.0001|TWO_SIDED|95.0|191.6|263.5||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/25 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/25 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||263.5|191.6|<0.0001
71024440|NCT01772368|141555810|SUPERIORITY||LSM difference|196.85|||<|0.0001|TWO_SIDED|95.0|161.2|232.5||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/12.5 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/512.5 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||232.5|161.2|<0.0001
71024441|NCT01772368|141555810|SUPERIORITY||LSM difference|151.71|||<|0.0001|TWO_SIDED|95.0|115.9|187.5||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/6.25 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/6.25 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||187.5|115.9|<0.0001
71024442|NCT01772368|141555810|SUPERIORITY||LSM difference|193.42|||<|0.0001|TWO_SIDED|95.0|157.4|229.5||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|Advair Diskus 100/50 mcg - Fp MDPI 100|The estimated treatment difference from the ANCOVA model between Advair Diskus 100/50 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||229.5|157.4|<0.0001
71024443|NCT01772368|141555810|SUPERIORITY||LSM difference|57.88||||0.0017|TWO_SIDED|95.0|22.0|93.7||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/50 - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/50 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||93.7|22.0|0.0017
71024444|NCT01772368|141555810|SUPERIORITY||LSM difference|34.14||||0.0624|TWO_SIDED|95.0|-1.8|70.1||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/25 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/25 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||70.1|-1.8|0.0624
71057145|NCT01753297|141619186|OTHER||Hazard Ratio (HR)|1.52||||0.653|TWO_SIDED|95.0|0.24|9.59|||Regression, Cox|||"Comparison between treatment groups: Triptorelin compared to Active surveillance.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||9.59|0.24|0.653
70934522|NCT02678455|141369778|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|83.0|||||TWO_SIDED|95.0|68.0|92.0||||||Young Children study participants seropositive to DENV-1 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||92|68|
70851713|NCT00893815|141191351|OTHER||Odds Ratio (OR)|0.55||||0.09|TWO_SIDED|95.0|0.27|1.1||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|||1.10|0.27|0.09
71024445|NCT01772368|141555810|SUPERIORITY||LSM difference|3.42||||0.8503|TWO_SIDED|95.0|-32.3|39.1||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/12.5mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/12.5 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||39.1|-32.3|0.8503
71024446|NCT01772368|141555810|SUPERIORITY||LSM difference|-41.72||||0.0229|TWO_SIDED|95.0|-77.6|-5.8||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/6.25 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/6.25 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||-5.8|-77.6|0.0229
71024447|NCT01772368|141555810|SUPERIORITY||LSM difference|-193.42|||<|0.0001|TWO_SIDED|95.0|-229.5|-157.4||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|Fp MDPI 100 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between Fp MDPI 100 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||-157.4|-229.5|<0.0001
71024448|NCT01772368|141555811|SUPERIORITY||LSM difference|226.77|||<|0.0001|TWO_SIDED|95.0|172.4|281.1||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/50 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/50 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||281.1|172.4|<0.0001
71024449|NCT01772368|141555811|SUPERIORITY||LSM difference|198.32|||<|0.0001|TWO_SIDED|95.0|143.7|252.9||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/25 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/25 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||252.9|143.7|<0.0001
71024450|NCT01772368|141555811|SUPERIORITY||LSM difference|158.99|||<|0.0001|TWO_SIDED|95.0|104.7|213.3||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/12.5 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/12.5 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||213.3|104.7|<0.0001
71024451|NCT01772368|141555811|SUPERIORITY||LSM difference|116.96|||<|0.0001|TWO_SIDED|95.0|62.4|171.6||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/6.25 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/6.25 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||171.6|62.4|<0.0001
71057146|NCT01753297|141619186|OTHER|||||||0.999|||||||Regression, Cox|||"Country effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||||0.999
71057147|NCT01753297|141619186|OTHER|||||||1|||||||Regression, Cox|||"Centre effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||||1.000
71057148|NCT01753297|141619186|OTHER|||||||0.583|||||||Regression, Cox|||"Gleason score effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||||0.583
71108036|NCT02949011|141721550|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.4874|TWO_SIDED|95.0|-0.08|0.16||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||24 hours||0.16|-0.08|0.4874
71108037|NCT02949011|141721550|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.47|-0.24||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||36 hours||-0.24|-0.47|<0.0001
71108038|NCT02949011|141721550|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.06||0.5414|TWO_SIDED|95.0|-0.15|0.08||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||36 hours||0.08|-0.15|0.5414
71108039|NCT02949011|141721550|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.44|-0.22||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||48 hours||-0.22|-0.44|<0.0001
71024452|NCT01772368|141555811|SUPERIORITY||LSM difference|159.01|||<|0.0001|TWO_SIDED|95.0|104.3|213.7||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|Advair Diskus 100/50 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between each Advair Diskus 100/50 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||213.7|104.3|<0.0001
71024453|NCT01772368|141555811|SUPERIORITY||LSM difference|67.76||||0.015|TWO_SIDED|95.0|13.3|122.2||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/50 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/50 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||122.2|13.3|0.0150
71024454|NCT01772368|141555811|SUPERIORITY||LSM difference|39.31||||0.1578|TWO_SIDED|95.0|-15.3|94.0||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/25 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/25 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||94.0|-15.3|0.1578
71024455|NCT01772368|141555811|SUPERIORITY||LSM difference|-0.02||||0.9993|TWO_SIDED|95.0|-54.4|54.4||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/12.5 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/12.5 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||54.4|-54.4|0.9993
71024456|NCT01772368|141555811|SUPERIORITY||LSM difference|-42.05||||0.1311|TWO_SIDED|95.0|-96.7|12.6||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/6.25 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/6.25 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||12.6|-96.7|0.1311
71024457|NCT01772368|141555811|SUPERIORITY||LSM difference|-159.01|||<|0.0001|TWO_SIDED|95.0|-213.7|-104.3||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|Fp MDPI 100 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between each Fp MDPI 100 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||-104.3|-213.7|<0.0001
70941679|NCT04748445|141383934|OTHER||Slope|0.0006145|STANDARD_ERROR_OF_MEAN|9.704||0.5277|TWO_SIDED|90.0|-0.0009936|0.002223|||Mixed Models Analysis|||MM\_Shimmer Local dB (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.002223|-0.0009936|0.5277
71024458|NCT01772368|141555812|SUPERIORITY||geometric mean ratio|1.929|||||TWO_SIDED|90.0|1.69|2.202||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=58||2.202|1.690|
71024459|NCT01772368|141555812|SUPERIORITY||geometric mean ratio|0.8|||||TWO_SIDED|90.0|0.702|0.911||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=59||0.911|0.702|
71024460|NCT01772368|141555812|SUPERIORITY||geometric mean ratio|0.427|||||TWO_SIDED|90.0|0.376|0.485||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=61||0.485|0.376|
71024461|NCT01772368|141555812|SUPERIORITY||LSM difference|0.172|||||TWO_SIDED|90.0|0.151|0.196||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=59||0.196|0.151|
71024462|NCT01772368|141555813|SUPERIORITY||geometric mean ratio|3.622|||||TWO_SIDED|90.0|3.149|4.168||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=58||4.168|3.149|
71024463|NCT01772368|141555813|SUPERIORITY||geometric mean ratio|1.534|||||TWO_SIDED|90.0|1.335|1.763||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=59||1.763|1.335|
71024464|NCT01772368|141555813|SUPERIORITY||geometric mean ratio|0.795|||||TWO_SIDED|90.0|0.694|0.911||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=61||0.911|0.694|
71024465|NCT01772368|141555813|SUPERIORITY||geometric mean ratio|0.339|||||TWO_SIDED|90.0|0.295|0.39||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=59||0.390|0.295|
71024466|NCT03551730|141555821|SUPERIORITY||Least Squares Means (Difference)|-0.23|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71024467|NCT03551730|141555821|SUPERIORITY||Least Squares Means (Difference)|-0.2|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71108040|NCT02949011|141721550|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.3185|TWO_SIDED|95.0|-0.17|0.05||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||48 hours||0.05|-0.17|0.3185
71024468|NCT03551730|141555821|SUPERIORITY||Least Squares Means (Difference)|-0.23|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71024469|NCT03551730|141555822|SUPERIORITY||Least Squares Means (Difference)|53922.58||||0.1529|TWO_SIDED||||||ANCOVA|||||||0.1529
71024470|NCT03551730|141555822|SUPERIORITY||Least Squares Means (Difference)|124993.1|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71024471|NCT03551730|141555822|SUPERIORITY||Least Squares Means (Difference)|96385.09||||0.0032|TWO_SIDED||||||ANCOVA|||||||0.0032
70934523|NCT02678455|141369778|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|100.0|||||TWO_SIDED|95.0|90.0|100.0||||||Young Children study participants seropositive to DENV-2 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|90|
70934524|NCT02678455|141369778|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|92.0|||||TWO_SIDED|95.0|78.0|97.0||||||Young Children study participants seropositive to DENV-3 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
71024472|NCT02363010|141555829|SUPERIORITY|||||||0.68||||||A prior threshold for statistical significance was p \< .05.|ANOVA|Controlling for baseline weight.||Exploring group differences in 12 month weight losses.||||.68
71024473|NCT02363010|141555829|SUPERIORITY|||||||0.11||||||A prior threshold for significance was p\<.05.|ANOVA|Controlling for baseline weight.||Exploring group differences in 18 month weight losses.||||.11
71057149|NCT01753297|141619188|OTHER|||||||0.557|||||||Log Rank|||A two-sided log-rank test was used to compare time to OS between both treatment groups.|1 death occurred in the active surveillance arm and 2 deaths occurred in the triptorelin arm.|||0.557
71057150|NCT01753297|141619191|OTHER|||||||0.525|||||||Log Rank|||A two-sided log-rank test was used to compare PSADT between both treatment groups.|Analysis was based on 9 PSADT events in the active surveillance arm and 6 PSADT events in the triptorelin arm.|||0.525
71057151|NCT01753297|141619191|OTHER||Hazard Ratio (HR)|1.72||||0.435|TWO_SIDED|95.0|0.44|6.73|||Regression, Cox|||"Comparison between treatment groups: Triptorelin compared to Active surveillance.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||6.73|0.44|0.435
71057152|NCT01753297|141619191|OTHER|||||||0.761|||||||Regression, Cox|||"Country effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||||0.761
71057153|NCT01753297|141619191|OTHER|||||||0.652|||||||Regression, Cox|||"Centre effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||||0.652
71057154|NCT01753297|141619191|OTHER|||||||0.726|||||||Regression, Cox|||"Gleason score effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||||0.726
70934525|NCT02678455|141369778|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|94.0|||||TWO_SIDED|95.0|82.0|98.0||||||Young Children study participants seropositive to DENV-4 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||98|82|
70934526|NCT02678455|141369780|SUPERIORITY||||||<|0.001||||||Comparison between experienced vs dengue naive volunteers post TV005 vaccination. Logistic model to adjust for age cohort provides unstable estimates due to quasi separation of data.|Fisher Exact|||DENV-1 percent seropositive post TV005 vaccination: difference between experienced at baseline and naive at baseline||||<0.001
71024474|NCT02363010|141555830|SUPERIORITY|||||||0.41||||||A priori threshold for statistical significance was p \< .05.|Compound Poisson general linear models|Controlling for baseline MVPA.||Exploring group differences in 12 month moderator to vigorous physical activity (MVPA).||||.41
71024475|NCT02363010|141555830|SUPERIORITY|||||||0.46||||||A priori threshold for statistical significance was p \< .05.|Compound Poisson general linear models|Controlling for baseline MVPA.||Exploring group differences in 12 month MVPA.||||.46
71057155|NCT01931878|141619220|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED||||||t-test, 2 sided|||comparison of mean RLS Scale scores between 21 incoA and 21 saline injections||||0.031
71057156|NCT01931878|141619221|SUPERIORITY_OR_OTHER|||||||0.0088|TWO_SIDED||||||Fisher Exact|||||||0.0088
71057157|NCT01931878|141619222|SUPERIORITY_OR_OTHER|||||||0.0855|TWO_SIDED||||||Fisher Exact|||||||0.0855
71057158|NCT00919126|141619248|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|The analysis of covariance was adjusted for quantity of propofol (mg) administered during the induction period, gender, type of surgery and centre.||The dose of propofol adjusted to BSA and maintenance duration was expected to be 4.0 mg/m².min in the control group, 2.8 mg/m².min in one xenon group and 3.0 mg/m².min in the other xenon group. With an expected common standard deviation of 2.0 mg/m².min, a type I error of 0.05 (two-sided) and a power of 0.80, the sample size required to show a statistically significant difference between the three groups was estimated to be 48 patients per group, resulting in a total of 144 randomised patients.||||<0.0001
71057159|NCT00919126|141619248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0256|||<|0.0001|TWO_SIDED|95.0|2.328|3.724||Pairwise comparison performed using Tukey's test.|ANCOVA|The analysis of covariance was adjusted for quantity of propofol (mg) administered during the induction period, gender, type of surgery and centre.|The difference Xenon 70% in Oxygen minus Medical Air in Oxygen was assessed.|||3.724|2.328|<0.0001
71057160|NCT00919126|141619248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2905|||<|0.0001|TWO_SIDED|95.0|1.57|3.011||Pairwise comparison performed using Tukey's test.|ANCOVA|The analysis of covariance was adjusted for quantity of propofol (mg) administered during the induction period, gender, type of surgery and centre.|The difference Xenon 50% in Oxygen minus Medical Air in Oxygen was assessed.|||3.011|1.570|<0.0001
71024476|NCT02363010|141555830|SUPERIORITY|||||||0.82||||||A priori threshold for statistical significance was p\< .05.|Compound Poisson general linear models|Controlling for baseline MVPA.||Exploring group differences in 12 month MVPA.||||.82
71024477|NCT02363010|141555830|SUPERIORITY|||||||0.42||||||A priori threshold for statistical significance was p \< .05.|Compound Poisson general linear models|Controlling for baseline MVPA.||Exploring group differences in 18 month MVPA.||||.42
71024478|NCT02363010|141555830|SUPERIORITY|||||||0.28||||||A priori threshold for statistical significance was p \< .05.|Compound Poisson general linear models|Controlling for baseline MVPA.||Exploring group differences in 18 month MVPA.||||.28
71024479|NCT02363010|141555830|SUPERIORITY|||||||0.82||||||A priori threshold for statistical significance was p \< .05.|Compound Poisson general linear models|Controlling for baseline MVPA.||Exploring group differences in 18 month MVPA.||||.82
71024480|NCT02363010|141555831|SUPERIORITY|||||||0.06||||||A priori threshold for statistical significance was p \< .05.|ANOVA|Controlling for baseline half-mile walk time.||Exploring group differences in 12 month cardiorespiratory fitness, measured by half-mile walk time.||||.06
71024481|NCT02363010|141555831|SUPERIORITY|||||||0.3||||||A priori threshold for statistical significance was p \< .05.|ANOVA|Controlling for baseline half-mile walk time.||Exploring group differences in 18 month cardiorespiratory fitness, measured by half-mile walk time.||||.30
71024482|NCT02363010|141555832|SUPERIORITY|||||||0.59||||||A priori threshold for statistical significance was p \< .05.|ANOVA|Controlling for baseline waist circumference.||Exploring group differences in 12 month waist circumference.||||.59
71024483|NCT02363010|141555832|SUPERIORITY|||||||0.57||||||A priori threshold for statistical significance was p \< .05.|ANOVA|Controlling for baseline waist circumference.||Exploring group differences in 18 month waist circumference.||||.57
71024484|NCT02363010|141555833|SUPERIORITY|||||||0.978||||||A priori threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that baseline Emotional Overeating would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.978
71024485|NCT02363010|141555833|SUPERIORITY|||||||0.998||||||A priori threshold for statistical significance was p \<.05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that baseline Emotional Overeating would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.998
71024486|NCT02363010|141555833|SUPERIORITY|||||||0.878||||||A priori threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that 6-month Emotional Overeating would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.878
71024487|NCT02363010|141555833|SUPERIORITY|||||||0.602||||||A priori threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that 6-month Emotional Overeating would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.602
71024488|NCT02363010|141555834|SUPERIORITY|||||||0.487||||||A prior threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that baseline Disinhibited Eating would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.487
71024489|NCT02363010|141555834|SUPERIORITY|||||||0.262||||||A prior threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that baseline Disinhibited Eating would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.262
71024490|NCT02363010|141555834|SUPERIORITY|||||||0.851||||||A prior threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that 6-month Disinhibited Eating would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.851
70934527|NCT02678455|141369780|SUPERIORITY|||||||1||||||Comparison between experienced vs. dengue naive volunteers post TV005 vaccination. Logistic model to adjust for age cohort provides unstable estimates due to quasi separation of data.|Fisher Exact|||DENV-2 percent seropositive post TV005 vaccination: difference between experienced at baseline and naive at baseline||||1.00
71024491|NCT02363010|141555834|SUPERIORITY|||||||0.978||||||A prior threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that 6-month Disinhibited Eating would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.978
71024492|NCT02363010|141555835|SUPERIORITY|||||||0.796||||||A prior threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that baseline Hedonic Hunger would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.796
71024493|NCT02363010|141555835|SUPERIORITY|||||||0.481||||||A prior threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that baseline Hedonic Hunger would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.481
71024494|NCT02363010|141555835|SUPERIORITY|||||||0.872||||||A prior threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that 6-month Hedonic Hunger would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.872
71024495|NCT02363010|141555835|SUPERIORITY|||||||0.802||||||A prior threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that 6-month Hedonic Hunger would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.802
71024496|NCT02363010|141555836|SUPERIORITY|||||||0.926||||||A prior threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that baseline Appetitive Response to Exercise would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.926
71024497|NCT02363010|141555836|SUPERIORITY|||||||0.82||||||A prior threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that baseline Appetitive Response to Exercise would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.820
71024498|NCT02363010|141555836|SUPERIORITY|||||||0.127||||||A prior threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that 6-month Appetitive Response to Exercise would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.127
71024499|NCT02363010|141555836|SUPERIORITY|||||||0.814||||||A prior threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that 6-month Appetitive Response to Exercise would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.814
71024500|NCT03907280|141555860|OTHER|Absolute bioavailability comparison|Ratio of the geometric means (T1/R) [%]|0.5|STANDARD_ERROR_OF_MEAN|1.15|||TWO_SIDED|90.0|0.39|0.63|||Mixed Models Analysis||The standard error of the mean is actually the geometric standard error.|Exploratory trial, no formal hypotheses were tested. Analysis of variance (ANOVA) on the logarithmic scale including effects for treatment sequence ('fixed effect'), subjects nested within treatment sequences ('random effect'), and treatment ('fixed effect').||0.63|0.39|
71024501|NCT03907280|141555860|OTHER|Absolute bioavailability comparison|Ratio of the geometric means (T2/R) [%]|40.26|STANDARD_ERROR_OF_MEAN|1.15|||TWO_SIDED|90.0|31.68|51.15|||Mixed Models Analysis||The standard error of the mean is actually the geometric standard error.|Exploratory trial, no formal hypotheses were tested. Analysis of variance (ANOVA) on the logarithmic scale including effects for treatment sequence ('fixed effect'), subjects nested within treatment sequences ('random effect'), and treatment ('fixed effect').||51.15|31.68|
71024502|NCT03907280|141555860|OTHER|Absolute bioavailability comparison|Ratio of the geometric means (T3/R) [%]|40.24|STANDARD_ERROR_OF_MEAN|1.15|||TWO_SIDED|90.0|31.86|50.83|||Mixed Models Analysis|The standard error of the mean is actually the geometric standard error.||Exploratory trial, no formal hypotheses were tested. Analysis of variance (ANOVA) on the logarithmic scale including effects for treatment sequence ('fixed effect'), subjects nested within treatment sequences ('random effect'), and treatment ('fixed effect').||50.83|31.86|
71024503|NCT02491788|141555861|SUPERIORITY||Mean Difference (Final Values)|2.16|STANDARD_ERROR_OF_MEAN|0.75|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
71024504|NCT00829413|141555865|SUPERIORITY_OR_OTHER||Difference in Sensitivity (%)|37.8|||<|0.0001|TWO_SIDED|95.0|27.4|48.2|||McNemar|||||48.2|27.4|<.0001
70934528|NCT02678455|141369780|SUPERIORITY|||||||0.07||||||Comparison between experienced vs. dengue naive volunteers post TV005 vaccination. Logistic model to adjust for age cohort provides unstable estimates due to quasi separation of data.|Fisher Exact|||DENV-3 percent seropositive post TV005 vaccination: difference between experienced at baseline and naive at baseline||||0.070
71024505|NCT00829413|141555865|SUPERIORITY_OR_OTHER||Difference in Sensitivity (%)|40.3|||<|0.0001|TWO_SIDED|95.0|30.4|50.3|||McNemar|||||50.3|30.4|<.0001
70934529|NCT02678455|141369780|SUPERIORITY|||||||1||||||Comparison between experienced vs. dengue naive volunteers post TV005 vaccination. logistic model to adjust for age cohort provides unstable estimates due to quasi separation of data.|Fisher Exact|||DENV-4 percent seropositive post TV005 vaccination: difference between experienced at baseline and naive at baseline||||1.00
71024506|NCT00829413|141555865|SUPERIORITY_OR_OTHER||Difference in Sensitivity (%)|75.6|||<|0.0001|TWO_SIDED|95.0|67.9|83.3|||McNemar|||||83.3|67.9|<.0001
71024507|NCT00829413|141555866|SUPERIORITY_OR_OTHER||Difference in Specificity (%)|7.9||||0.138|TWO_SIDED|95.0|-2.4|18.2|||McNemar|||||18.2|-2.4|0.1380
71024508|NCT00829413|141555866|SUPERIORITY_OR_OTHER||Difference in Specificity (%)|28.6|||<|0.0001|TWO_SIDED|95.0|19.7|37.5|||McNemar|||||37.5|19.7|<.0001
71024509|NCT00829413|141555866|SUPERIORITY_OR_OTHER||Difference in Specificity (%)|50.7|||<|0.0001|TWO_SIDED|95.0|42.0|59.5|||McNemar|||||59.5|42.0|<.0001
71024510|NCT00829413|141555867|SUPERIORITY_OR_OTHER||Difference in Accuracy (%)|21.6|||<|0.0001|TWO_SIDED|95.0|14.1|29.2|||McNemar|||||29.2|14.1|<.0001
71024511|NCT00829413|141555867|SUPERIORITY_OR_OTHER||Difference in Accuracy (%)|34.0|||<|0.0001|TWO_SIDED|95.0|27.3|40.7|||McNemar|||||40.7|27.3|<.0001
71024512|NCT00829413|141555867|SUPERIORITY_OR_OTHER||Difference in Accuracy (%)|75.6|||<|0.0001|TWO_SIDED|95.0|67.9|83.3|||McNemar|||||83.3|67.9|<.0001
71108041|NCT02949011|141721550|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.05||0.0025|TWO_SIDED|95.0|-0.26|-0.06||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||72 hours||-0.06|-0.26|0.0025
71024513|NCT00829413|141555868|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
71024514|NCT00829413|141555868|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
71024515|NCT00829413|141555868|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
71024516|NCT00829413|141555869|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
71057161|NCT00919126|141619248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7351||||0.0365|TWO_SIDED|95.0|0.038|1.432||Pairwise comparison was performed using the Tukey's test.|ANCOVA|The analysis of covariance was adjusted for quantity of propofol (mg) administered during the induction period, gender, type of surgery and centre.|The difference Xenon 70% in Oxygen minus Xenon 50% in Oxygen was assessed|||1.432|0.038|0.0365
71057162|NCT02032680|141619261|SUPERIORITY|||||||0.3749|||||||Cochran-Armitage Trend Test|||The two treatments were compared to see whether participants in one achieved a higher level on their goals (i.e., the maximum level achieved on the goal).||||0.3749
71057163|NCT00687830|141619273|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
71024517|NCT00829413|141555869|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
71024518|NCT00829413|141555869|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
71057164|NCT00687830|141619274|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Chi-squared|||||||0.04
71057165|NCT00295061|141619301|NON_INFERIORITY_OR_EQUIVALENCE|A total sample size of 20 subjects could demonstrate comparability of an AUC(0-7days) with 90% power up to a standard deviation of 0.288 of the difference in the log scale, expected mean treatment difference of 0 (= ratio of 1), a lower equivalence limit of -0.223 (= log 0.8), upper limit of 0.223 (= log 1.25) and a one-sided alpha of 0.05 (90% CI).|Geometric least square means ratio|1.03||||||90.0|0.97|1.09||||||To compare AUC 0-7 days between the two treatments (Alpha-1 MP vs. Prolastin),natural log-transformed AUC 0-7 days values were analyzed by analysis of variance (ANOVA).||1.09|0.97|
71057166|NCT00101283|141619307|SUPERIORITY_OR_OTHER_LEGACY||Overall Response Percent|18.8|||||TWO_SIDED|90.0|5.4|41.7|||||Overall response percent for Pemetrexed/Carboplatin arm (percent of eligible, treated patients with complete or partial response)|The treatment was to be considered promising if a true response rate of 40% or higher was observed, whereas a rate of 15% or less would not be of interest. 3 or more responses were required to expand accrual to a second stage. This expansion did not occur.||41.7|5.4|
71057167|NCT00101283|141619307|SUPERIORITY_OR_OTHER_LEGACY||Overall Response Percent|0.0|||||TWO_SIDED|90.0|0.0|20.6|||||Overall response percent for Pemetrexed/Gemcitabine arm (percent of eligible, treated patients with complete or partial response)|The treatment was to be considered promising if a true response rate of 40% or higher was observed, whereas a rate of 15% or less would not be of interest. 3 or more responses were required to expand accrual to a second stage. This expansion did not occur.||20.6|0.0|
71024519|NCT01464827|141555874|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.406|TWO_SIDED|95.0|0.09|2.61||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Regression, Logistic||Odds ratio: Group A : Group G|"The primary efficacy endpoint was the comparison of the percentage of treatment-naïve participants with SVR24 after treatment with 3 DAAs (at the 150 mg ABT-450 dose) and ribavirin for 8 weeks (Group A) versus 12 weeks (Group G).~Logistic regression with baseline log10 HCV RNA level, treatment group, Interleukin 28B genotype (CC or non-CC), HCV subgenotype (1a or non-1a), and geographic region (US or non-US) as predictors."||2.61|0.09|0.406
71024520|NCT01464827|141555875|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.266|TWO_SIDED|95.0|0.08|2.02||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Regression, Logistic||Odds ratio: Group A : Groups \[F + G + K + L\]|The percentage of participants with SVR24 after treatment for 8 weeks versus 12 weeks was compared using logistic regression with treatment group, baseline log10 HCV RNA level, HCV subgenotype (1a or non-1a), geographic region (US or non-US), Interleukin 28B genotype (CC or non-CC), and ABT-450/ritonavir dose and population (treatment-naïve or null-responders) as predictors.||2.02|0.08|0.266
71024521|NCT01464827|141555875|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.525|TWO_SIDED|95.0|0.18|2.4||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Regression, Logistic||Odds ratio: Group A : Groups \[H + I + M + N\]|The percentage of participants with SVR24 after treatment for 8 weeks versus 24 weeks was compared using logistic regression with treatment group, baseline log10 HCV RNA level, HCV subgenotype (1a or non-1a), geographic region (US or non-US), Interleukin 28B genotype (CC or non-CC), ABT-450/ritonavir dose and population (treatment-naïve or null-responders) as predictors.||2.40|0.18|0.525
71024522|NCT01464827|141555875|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.375|TWO_SIDED|95.0|0.55|4.92||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Regression, Logistic||Odds ratio: Groups \[F + G + K + L\] : Groups \[H + I + M + N\]|The percentage of participants with SVR24 after treatment for 12 weeks versus 24 weeks was compared using logistic regression with treatment group, baseline log10 HCV RNA level, HCV subgenotype (1a or non-1a), geographic region (US or non-US), Interleukin 28B genotype (CC or non-CC), ABT-450/ritonavir dose and population (treatment-naïve or null-responders) as predictors.||4.92|0.55|0.375
71108042|NCT02949011|141721550|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.8299|TWO_SIDED|95.0|-0.09|0.11||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||72 hours||0.11|-0.09|0.8299
71108043|NCT02949011|141721550|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.0878|TWO_SIDED|95.0|-0.19|0.01||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||96 hours||0.01|-0.19|0.0878
71108044|NCT02949011|141721550|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.7498|TWO_SIDED|95.0|-0.09|0.12||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||96 hours||0.12|-0.09|0.7498
71108045|NCT02949011|141721550|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.803|TWO_SIDED|95.0|-0.11|0.09||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||120 hours||0.09|-0.11|0.8030
71108046|NCT02949011|141721550|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.3577|TWO_SIDED|95.0|-0.05|0.15||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||120 hours||0.15|-0.05|0.3577
71108047|NCT02949011|141721551|SUPERIORITY||Median Difference|-23.1||||0.0009||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Cough||||0.0009
71108048|NCT02949011|141721551|SUPERIORITY||Median Difference|-0.2||||0.4074||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Cough||||0.4074
71108049|NCT02949011|141721551|SUPERIORITY||Median Difference|-6.3||||0.2496||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Sore Throat||||0.2496
71024523|NCT01464827|141555876|SUPERIORITY_OR_OTHER||Difference|-12.16||||0.068|TWO_SIDED|95.0|-25.2|0.88||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Mantel Haenszel|The Mantel-Haenszel method was used because logistic regression failed due to separation or quasi-separation.|Difference = Group B - Groups \[F + G + K + L\]|The percentage of participants with SVR24 after treatment with 2 DAAs and ribavirin versus 3 DAAs and ribavirin was compared using stratum-adjusted Mantel-Haenszel (MH) method with Interleukin 28B genotype (CC or non-CC) and HCV subgenotype (1a or non-1a).||0.88|-25.20|0.068
71024524|NCT01464827|141555876|SUPERIORITY_OR_OTHER||Difference|-6.75||||0.065|TWO_SIDED|95.0|-13.93|0.43||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Mantel Haenszel|The Mantel-Haenszel method was used because logistic regression failed due to separation or quasi-separation.|Difference = Groups \[C + D + J\] - Groups \[F + G + K + L\]|The percentage of participants with SVR24 after treatment with 2 DAAs and ribavirin versus 3 DAAs and ribavirin was compared using stratum-adjusted Mantel-Haenszel (MH) method with Interleukin 28B genotype (CC or non-CC) and HCV subgenotype (1a or non-1a).||0.43|-13.93|0.065
71024525|NCT01464827|141555877|SUPERIORITY_OR_OTHER||Difference|-7.13||||0.106|TWO_SIDED|95.0|-15.77|1.51||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Mantel Haenszel|The Mantel-Haenszel method was used because logistic regression failed due to separation or quasi-separation.|Difference = Group E - Groups \[F + G + K + L\]|The percentage of participants with SVR24 after treatment with 3 DAAs with and without ribavirin was compared using a stratum-adjusted Mantel-Haenszel (MH) method with Interleukin 28B genotype (CC or non-CC) and HCV subgenotype (1a or non-1a).||1.51|-15.77|0.106
71057168|NCT02604407|141619312|SUPERIORITY_OR_OTHER_LEGACY||Difference of LS Mean|-8.1|||<|0.001|TWO_SIDED|95.0|-11.7|-4.4|||Mixed-effects model for repeated measure||Between treatment groups of SHP465 12.5 mg and Placebo.|||-4.4|-11.7|<0.001
71057169|NCT02604407|141619312|SUPERIORITY_OR_OTHER_LEGACY||Difference of LS Mean|-13.4|||<|0.001|TWO_SIDED|95.0|-17.1|-9.7|||Mixed-effects model for repeated measure||Between treatment groups of SHP465 37.5 mg and Placebo.|||-9.7|-17.1|<0.001
71057170|NCT00606632|141619317|SUPERIORITY|||||||0.023|||||||McNemar|||||||0.023
71057171|NCT00606632|141619317|SUPERIORITY||||||<|0.01|||||||McNemar|||||||<0.01
71108050|NCT02949011|141721551|SUPERIORITY||Median Difference|0.9||||0.2963||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Sore Throat||||0.2963
71057172|NCT03633825|141619333|SUPERIORITY||Risk Ratio (RR)|1.23|||=|0.02|TWO_SIDED|95.0|1.03|1.46|||Chi-squared|||||1.46|1.03|=.02
71057173|NCT03633825|141619334|SUPERIORITY||Risk Ratio (RR)|1.2|||=|0.19|TWO_SIDED|95.0|0.91|1.59|||Chi-squared|||||1.59|0.91|=.19
71057174|NCT03837743|141619415|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|0.42||0.022|TWO_SIDED||||||Paired t-test|||Difference in Change (week 4)||||0.022
71057175|NCT03837743|141619415|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|0.8||0.296|TWO_SIDED||||||Paired t-test|||Difference in Change (week 8)||||0.296
71108051|NCT02949011|141721551|SUPERIORITY||Median Difference|-10.6||||0.039||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Headache||||0.0390
71024526|NCT01464827|141555878|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.616|TWO_SIDED|95.0|0.37|5.34||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Regression, Logistic||Odds ratio: Groups \[F + G + H + I\] : Groups \[K + L + M + N\]|The percentage of participants with SVR24 after treatment with 3 DAAs and ribavirin in treatment-naïve versus null-responders was compared using logistic regression with treatment group, baseline log10 HCV RNA level, HCV subgenotype (1a or non-1a), geographic region (US or non-US), Interleukin 28B genotype (CC or non-CC), and ABT-450/ritonavir dose as predictors.||5.34|0.37|0.616
71024527|NCT00124020|141555892|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 20% was specified based on historical regulatory precedent.|Risk Difference (RD)|0.2||||||95.0|-6.8|7.2||p-values were not calculated in deference to confidence intervals.||||||7.2|-6.8|
71024528|NCT01127581|141555900|SUPERIORITY_OR_OTHER||Median Difference (Net)|-677.0|||<|0.001|TWO_SIDED|95.0|||||Log Rank||Sample size 675 per group provides 90% power to see an improvement of ≥320 minutes (20% improvement from DVI) in time to vaginal delivery between MVI 200 \& DVI assuming a median time of 1600 minutes for DVI \& 34% dropout rate based on 5% 2-sided test|Subjects who underwent a cesarean delivery during the first hospitalization were censored using the longest time interval from study drug administration to cesarean delivery during the first hospitalization, independent of treatment group. Subjects who, in their first hospitalization, were discharged prior to delivery or withdrew consent prior to delivery were censored using the longest time interval from study drug administration to labor and delivery discharge, independent of treatment group.||||<0.001
71024529|NCT01127581|141555901|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 675 subjects per group will provide a sufficient number of subjects to assess non-inferiority of MVI 200 with respect to rate of cesarean delivery, based on an alpha level of 5% and 80% power for a two-sided approach using a 10% non-inferiority limit (relative to the DVI rate), assuming a 30% rate of cesarean delivery in the DVI group compared to a 26% rate in the MVI 200 group.|Difference in Populations|-1.1|||||TWO_SIDED|95.0|-5.79|3.59|||Chi-squared||MVI 200 - DVI|The analysis of the cesarean delivery rates during the first hospitalization was based on a between-treatment-group difference. If the upper limit of the asymptotic two-sided 95% confidence interval of the difference in event rates (MVI minus DVI) was less than the calculated non-inferiority margin (10% relative to the DVI rate, i.e., 0.1 times DVI rate), then MVI 200 would be considered non-inferior to DVI.||3.59|-5.79|
71024530|NCT01127581|141555902|SUPERIORITY_OR_OTHER||Median Difference (Net)|-543.0|||<|0.001|TWO_SIDED|95.0|||||Log Rank||MVI 200 - DVI|Subjects who did not deliver during the first hospitalization were censored using the longest time interval from study drug administration to labor and delivery discharge without delivery, independent of treatment group.||||<0.001
71024531|NCT01127581|141555903|SUPERIORITY_OR_OTHER||Median Difference (Net)|-390.0|||<|0.001|TWO_SIDED|95.0|||||Log Rank||MVI 200 - DVI|Subjects who never went into active labor during the first hospitalization were censored using the longest time interval from study drug administration to delivery during the first hospitalization, independent of treatment group. Subjects who, in their first hospitalization, were discharged prior to delivery or withdrew consent prior to delivery were censored using the longest time interval from study drug administration to labor and delivery discharge, independent of treatment group.||||<0.001
71024532|NCT01127581|141555904|SUPERIORITY_OR_OTHER||Difference in Proportions|-26.0|||<|0.001|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - DVI|||||<0.001
71024533|NCT01127581|141555905|SUPERIORITY_OR_OTHER||Difference in Proportions|9.67|||<|0.001|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - DVI|||||<0.001
71024534|NCT01127581|141555906|SUPERIORITY_OR_OTHER||Difference in Proportions|26.96|||<|0.001|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - DVI|||||<0.001
71024535|NCT01127581|141555907|SUPERIORITY_OR_OTHER||Difference in Proportions|13.9|||<|0.001|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - DVI|||||<0.001
71057176|NCT01130597|141619438|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|90.5|||||TWO_SIDED|95.0|80.4|96.4|||||Clopper-Pearson was used to arrive at the 95% Confidence Interval|||96.4|80.4|
71024536|NCT01127581|141555908|SUPERIORITY_OR_OTHER||Difference in Proportions|29.8|||<|0.001|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - DVI|||||<0.001
71057177|NCT01130597|141619443|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|84.1|||||TWO_SIDED|95.0|72.7|92.1|||||Clopper-Pearson was used to arrive at the 95% Confidence Interval|||92.1|72.7|
71057178|NCT04873934|141619465|SUPERIORITY||LS mean difference|-46.9|||<|0.001|TWO_SIDED|97.5|-55.4|-38.5|||Mixed Models Analysis|||||-38.5|-55.4|< 0.001
71057179|NCT04873934|141619466|SUPERIORITY||Odds Ratio (OR)|5.42|||<|0.001|TWO_SIDED|97.5|3.29|8.91|||Regression, Logistic|||||8.91|3.29|< 0.001
71057180|NCT04873934|141619467|SUPERIORITY||LS mean difference|-42.0|||<|0.001|TWO_SIDED|95.0|-47.3|-36.7|||Mixed Models Analysis|||Day 90||-36.7|-47.3|< 0.001
71057181|NCT04873934|141619467|SUPERIORITY||LS mean difference|-30.8|||<|0.001|TWO_SIDED|95.0|-37.4|-24.3|||Mixed Models Analysis|||Day 270||-24.3|-37.4|< 0.001
71057182|NCT04873934|141619467|SUPERIORITY||LS mean difference|-37.7|||<|0.001|TWO_SIDED|95.0|-44.5|-31.0|||Mixed Models Analysis|||Day 330||-31.0|-44.5|< 0.001
71057183|NCT04873934|141619468|SUPERIORITY||LS mean difference|-46.7|||<|0.001|TWO_SIDED|95.0|-52.7|-40.8|||ANCOVA|||||-40.8|-52.7|< 0.001
71057184|NCT04873934|141619469|SUPERIORITY||LS mean difference|-37.3|||<|0.001|TWO_SIDED|95.0|-42.4|-32.2|||ANCOVA|||||-32.2|-42.4|< 0.001
71057185|NCT04873934|141619470|SUPERIORITY||Odds Ratio (OR)|11.87|||<|0.001|TWO_SIDED|95.0|6.33|22.25|||Regression, Logistic|||||22.25|6.33|< 0.001
71057186|NCT04873934|141619471|SUPERIORITY||Odds Ratio (OR)|4.38|||<|0.001|TWO_SIDED|95.0|1.92|9.99|||Regression, Logistic|||Achieving LDL-C \< 100 mg/dL||9.99|1.92|< 0.001
71057187|NCT04873934|141619471|SUPERIORITY||Odds Ratio (OR)|8.24|||<|0.001|TWO_SIDED|95.0|4.97|13.65|||Regression, Logistic|||Achieving LDL-C \< 55 mg/dL||13.65|4.97|< 0.001
71024537|NCT01127581|141555909|SUPERIORITY_OR_OTHER||Difference in Proportions|1.68|||<|0.001|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - DVI|||||<0.001
71024538|NCT02927847|141555934|OTHER||t-value|0.138||||0.891|TWO_SIDED||||||t-test, 2 sided|||||||0.891
71024539|NCT02927847|141555935|OTHER||t-value|-0.575||||0.571|TWO_SIDED||||||t-test, 2 sided|||||||0.571
71024540|NCT02927847|141555936|OTHER||Odds Ratio (OR)|1.17||||0.739|TWO_SIDED||||||Regression, Cox|||||||0.739
71024541|NCT00723554|141555958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.1|||<|0.001|TWO_SIDED|95.0|-6.9|-5.4|||t-test, 2 sided|||Comparison of the change in average inhalation times from Period I (PD-6) to Period II (PD-15)||-5.4|-6.9|<0.001
71024542|NCT00723554|141555962|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.59|TWO_SIDED|95.0|-1.0|0.6|||t-test, 2 sided|||Comparison of the change in average number of days of dosing from Period I (PD-6) to Period II (PD-15)||0.6|-1.0|0.59
71057188|NCT04873934|141619472|SUPERIORITY||LS mean difference|-37.5|||<|0.001|TWO_SIDED|95.0|-44.8|-30.3|||Mixed Models Analysis|||Apolipoprotein B||-30.3|-44.8|< 0.001
70934530|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|66.0|||||TWO_SIDED|95.0|49.0|79.0||||||Adult cohort: percent seropositive to DENV-1 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||79|49|
70934531|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|83.0|||||TWO_SIDED|95.0|67.0|92.0||||||Adult cohort: percent seropositive to DENV-1 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||92|67|
71057189|NCT04873934|141619472|SUPERIORITY||LS mean difference|-6.4||||0.188|TWO_SIDED|95.0|-16.0|3.1|||Mixed Models Analysis|||VLDL Cholesterol||3.1|-16.0|0.188
70934532|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|80.0|||||TWO_SIDED|95.0|64.0|90.0||||||Adult cohort: percent seropositive to DENV-1 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|64|
71024543|NCT00723554|141555966|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|||<|0.001|TWO_SIDED|95.0|0.2|0.7|||t-test, 2 sided|||Comparison of the change in average number of daily doses from Period I (PD-6) to Period II (PD-15)||0.7|0.2|<0.001
71024544|NCT00723554|141555970|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.0|||<|0.0001|TWO_SIDED|95.0|6.5|15.6|||t-test, 2 sided|||Comparison of the change in percentage of complete doses delivered from Period I (PD-6) to Period II (PD-15)||15.6|6.5|<0.0001
71024545|NCT01614509|141555998|NON_INFERIORITY_OR_EQUIVALENCE|Central retinal thickness was measured using an optical coherence tomography by every visit intended for all participants.||||||0.6||95.0|||||Wilcoxon (Mann-Whitney)|||Central retinal thickness was measured using an optical coherence tomography by every visit. And we compare the difference of central retinal thickness between two groups||||0.60
71024546|NCT01952574|141556000|SUPERIORITY|To maintain the type I error at ≤ 0.05, the pairwise comparison was tested in a sequential testing procedure in the order of erenumab 70 mg vs placebo, 21 mg vs placebo, and 7 mg vs placebo. The lower dose group was only to be tested when the higher dose group was tested as significant.|LS Mean Difference|-1.12||||0.021|TWO_SIDED|95.0|-2.06|-0.17|||Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.||-0.17|-2.06|0.021
71024547|NCT01952574|141556000|SUPERIORITY|To maintain the type I error at ≤ 0.05, the pairwise comparison was tested in a sequential testing procedure in the order of erenumab 70 mg vs placebo, 21 mg vs placebo, and 7 mg vs placebo. The lower dose group was only to be tested when the higher dose group was tested as significant.|LS Mean Difference|-0.1||||0.83|TWO_SIDED|95.0|-1.07|0.86|||Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.||0.86|-1.07|0.83
71024548|NCT01952574|141556000|SUPERIORITY|To maintain the type I error at ≤ 0.05, the pairwise comparison was tested in a sequential testing procedure in the order of erenumab 70 mg vs placebo, 21 mg vs placebo, and 7 mg vs placebo. The lower dose group was only to be tested when the higher dose group was tested as significant.|LS Mean Difference|0.11||||0.82|TWO_SIDED|92.0|-0.83|1.05|||Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.||1.05|-0.83|0.82
71024549|NCT01952574|141556001|SUPERIORITY||Odds Ratio (OR)|2.0||||0.011|TWO_SIDED|95.0|1.17|3.42|||Generalised Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, stratification factor region, and baseline value as covariates.||The generalized linear mixed model includes data for all participants in the efficacy analysis set with at least one percent change from baseline value in monthly migraine days (152 participants in the placebo group and 104 in the erenumab 70 mg group)||3.42|1.17|0.011
71057190|NCT04873934|141619472|SUPERIORITY||LS mean difference|-37.7|||<|0.001|TWO_SIDED|95.0|-44.0|-31.4|||Mixed Models Analysis|||Non-HDL Cholesterol||-31.4|-44.0|< 0.001
71057191|NCT04873934|141619472|SUPERIORITY||LS mean difference|-25.5|||<|0.001|TWO_SIDED|95.0|-30.2|-20.7|||Mixed Models Analysis|||Total Cholesterol||-20.7|-30.2|< 0.001
71057192|NCT04873934|141619472|SUPERIORITY||LS mean difference|-16.4||||0.145|TWO_SIDED|95.0|-38.4|5.7|||Mixed Models Analysis|||Lipoprotein(a)||5.7|-38.4|0.145
71057193|NCT04873934|141619472|SUPERIORITY||LS mean difference|3.5||||0.141|TWO_SIDED|95.0|-1.2|8.1|||Mixed Models Analysis|||HDL Cholesterol||8.1|-1.2|0.141
71057194|NCT04873934|141619472|SUPERIORITY||LS mean difference|-5.0||||0.339|TWO_SIDED|95.0|-15.2|5.3|||Mixed Models Analysis|||Triglycerides||5.3|-15.2|0.339
71057195|NCT04873934|141619473|SUPERIORITY||LS mean difference|-28.4|||<|0.001|TWO_SIDED|95.0|-33.0|-23.9|||Mixed Models Analysis|||Apolipoprotein B||-23.9|-33.0|< 0.001
71057196|NCT04873934|141619473|SUPERIORITY||LS mean difference|-2.1||||0.078|TWO_SIDED|95.0|-4.5|0.2|||Mixed Models Analysis|||VLDL Cholesterol||0.2|-4.5|0.078
71024550|NCT01952574|141556001|SUPERIORITY||Odds Ratio (OR)|1.25||||0.44|TWO_SIDED|95.0|0.71|2.18|||Generalized Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, stratification factor region, and baseline value as covariates.||The generalized linear mixed model includes data for all participants in the efficacy analysis set with at least one change from baseline value in monthly migraine days (152 participants in the placebo group and 99 in the erenumab 21 mg group)||2.18|0.71|0.44
71024551|NCT01952574|141556001|SUPERIORITY||Odds Ratio (OR)|0.93||||0.8|TWO_SIDED|95.0|0.53|1.63|||Generalized Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, stratification factor region, and baseline value as covariates.||The generalized linear mixed model includes data for all participants in the efficacy analysis set with at least one change from baseline value in monthly migraine days (152 participants in the placebo group and 107 in the erenumab 7 mg group)||1.63|0.53|0.80
70934533|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|80.0|||||TWO_SIDED|95.0|64.0|90.0||||||Adult cohort: percent seropositive to DENV-1 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|64|
71057197|NCT04873934|141619473|SUPERIORITY||LS mean difference|-40.1|||<|0.001|TWO_SIDED|95.0|-47.5|-32.8|||Mixed Models Analysis|||Non-HDL Cholesterol||-32.8|-47.5|< 0.001
71057198|NCT04873934|141619473|SUPERIORITY||LS mean difference|-37.7|||<|0.001|TWO_SIDED|95.0|-45.3|-30.2|||Mixed Models Analysis|||Total Cholesterol||-30.2|-45.3|< 0.001
71057199|NCT04873934|141619473|SUPERIORITY||LS mean difference|1.9||||0.065|TWO_SIDED|95.0|-0.1|3.8|||Mixed Models Analysis|||HDL Cholesterol||3.8|-0.1|0.065
71057200|NCT04873934|141619473|SUPERIORITY||LS mean difference|-8.7||||0.222|TWO_SIDED|95.0|-22.8|5.3|||Mixed Models Analysis|||Triglycerides||5.3|-22.8|0.222
71057201|NCT04873934|141619474|SUPERIORITY||LS mean difference|-14.0||||0.005|TWO_SIDED|95.0|-23.8|-4.2|||Mixed Models Analysis|||Lipoprotein(a)||-4.2|-23.8|0.005
71057202|NCT04873934|141619475|SUPERIORITY||Odds Ratio (OR)|0.43||||0.031|TWO_SIDED|95.0|0.2|0.93|||proportional odds model|||||0.93|0.20|0.031
71057203|NCT04873934|141619476|SUPERIORITY||LS mean difference|-0.039||||0.043|TWO_SIDED|95.0|-0.077|-0.001|||ANCOVA|||||-0.001|-0.077|0.043
71108052|NCT02949011|141721551|SUPERIORITY||Median Difference|2.0||||0.7877||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Headache||||0.7877
71108053|NCT02949011|141721551|SUPERIORITY||Median Difference|-12.1||||0.0017||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Nasal Congestion||||0.0017
71024552|NCT01952574|141556002|SUPERIORITY||LS Mean Difference|-0.4||||0.13|TWO_SIDED|95.0|-0.92|0.12|||Generalized Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.||||0.12|-0.92|0.13
71057204|NCT04873934|141619477|SUPERIORITY||Odds Ratio (OR)|0.76||||0.346|TWO_SIDED|95.0|0.43|1.35|||Regression, Logistic|||||1.35|0.43|0.346
71057205|NCT04102189|141619507|SUPERIORITY||Treatment difference|-16.75|||<|0.0001|TWO_SIDED|95.0|-20.27|-13.23|||ANCOVA|||Responses were analyzed using an analysis of covariance model with randomized treatment, stratification groups (sex and Tanner stage at baseline) and the interaction between stratification groups as factors and baseline BMI as covariate.||-13.23|-20.27|<.0001
71057206|NCT02933255|141619548|OTHER||||||<|0.0001||||||The reported p-value is representative of changes in CD8+T cell infiltration within the total tissue at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||<0.0001
71057207|NCT02933255|141619548|OTHER|||||||0.04||||||The reported p-value is representative of changes in CD8+T cell infiltration in the center of the tumor at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||0.04
71057208|NCT02933255|141619548|OTHER|||||||0.002||||||The reported p-value is representative of changes in CD8+T cell infiltration in the invasive margin at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||0.002
71057209|NCT02933255|141619548|OTHER|||||||0.46||||||The reported p-value is representative of changes in CD8+T cell infiltration in the normal region at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||0.46
71108054|NCT02949011|141721551|SUPERIORITY||Median Difference|1.5||||0.8119||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Nasal Congestion||||0.8119
71057210|NCT02933255|141619548|OTHER||||||<|0.0001||||||The reported p-value is representative of changes in CD4 T cell helper infiltration in the total tissue at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||<0.0001
71057211|NCT02933255|141619548|OTHER|||||||0.016||||||The reported p-value is representative of changes in CD4 T cell helper infiltration in the center of the tumor at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||0.016
71057212|NCT02933255|141619548|OTHER|||||||0.002||||||The reported p-value is representative of changes in CD4 T cell helper infiltration in the invasive margin at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||0.002
71057213|NCT02933255|141619548|OTHER|||||||0.38||||||The reported p-value is representative of changes in CD4 T cell helper infiltration in the normal region at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||0.38
71057214|NCT02933255|141619550|OTHER|The reported p-value is representative of changes in soluble factors at 4 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.||||||0.064|||||||Wilcoxon Signed Rank Test|||||||0.064
71057215|NCT02933255|141619550|OTHER|The reported p-value is representative of changes in soluble factors at 4 weeks of therapy compared to baseline in the neoadjuvant cohort.||||||0.001|||||||Wilcoxon Signed Rank Test|||||||0.001
71057216|NCT02933255|141619550|OTHER|||||||0.003||||||The reported p-value is representative of changes in soluble factors at 10 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||0.003
71024553|NCT01952574|141556002|SUPERIORITY||LS Mean Difference|0.02||||0.95|TWO_SIDED|95.0|-0.51|0.54|||Generalized Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.||||0.54|-0.51|0.95
71024554|NCT01952574|141556002|SUPERIORITY||LS Mean Difference|0.37||||0.16|TWO_SIDED|95.0|-0.14|0.87|||Generalized Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.||||0.87|-0.14|0.16
71024555|NCT01335464|141556051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|125.26|STANDARD_ERROR_OF_MEAN|24.209|<|0.0001|TWO_SIDED|95.0|77.68|172.84||The objective of this trial was to assess the superiority of nintedanib 150 mg bid compared to placebo on the annual rate of decline in FVC.|Random coefficient regression|The Roger-Kenward approximation was used to estimate denominators degrees of freedom.|"Within-patient errors are modelled by an Unstructured variance-covariance matrix.~Inter-individual variability is modelled by a Variance-components variance-covariance matrix~Nintedanib 150 mg bid versus Placebo"|"Random coefficient regression with fixed effects for treatment, gender, age, height and random effect of patient specific intercept and time.~A hierarchical procedure was used in order to demonstrate the superiority of nintedanib over placebo for one primary and two key secondary endpoints.~The consecutive steps of the hierarchy were only considered if the previous step was significant at the one-sided 2.5% level and the results were in favour of nintedanib."||172.84|77.68|<0.0001
71024556|NCT01335464|141556052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|1.248||0.9657|TWO_SIDED|95.0|-2.5|2.4|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix~Nintedanib 150 mg bid versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Total score, baseline SGRQ Total score-by-visit and random effect for patient.||2.40|-2.50|0.9657
71024557|NCT01335464|141556053|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.6728|TWO_SIDED|95.0|0.54|2.42|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard Ratio is based on a Cox´s regression model with terms for treatment, gender, age and height||2.42|0.54|0.6728
71024558|NCT01335464|141556054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|109.93|STANDARD_ERROR_OF_MEAN|19.708|<|0.0001|TWO_SIDED|95.0|71.27|148.59|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC, baseline FVC-by-visit and random effect for patient.||148.59|71.27|<0.0001
71024559|NCT01335464|141556055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.02|STANDARD_ERROR_OF_MEAN|0.753|<|0.0001|TWO_SIDED|95.0|2.54|5.5|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC, baseline FVC-by-visit and random effect for patient.||5.50|2.54|<0.0001
71024560|NCT01335464|141556056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.22|STANDARD_ERROR_OF_MEAN|0.564|<|0.0001|TWO_SIDED|95.0|2.11|4.33|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC \[%predicted\], baseline FVC \[%predicted\]-by-visit and random effect for patient.||4.33|2.11|<0.0001
71024561|NCT01335464|141556057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|0.753|<|0.0001|TWO_SIDED|95.0|2.52|5.48|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC \[%predicted\], baseline FVC \[%predicted\]-by-visit and random effect for patient.||5.48|2.52|<0.0001
71024562|NCT01335464|141556060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.914||||0.0007|TWO_SIDED|95.0|1.32|2.79|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, age, gender, height and baseline FVC % predicted||2.79|1.32|0.0007
71024563|NCT01335464|141556061|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.847||||0.001|TWO_SIDED|95.0|1.28|2.66|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, age, gender, height and baseline FVC % predicted||2.66|1.28|0.0010
71024564|NCT01335464|141556062|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.4298|TWO_SIDED|95.0|0.55|1.29|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, baseline SGRQ total score||1.29|0.55|0.4298
71024565|NCT01335464|141556063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.32|STANDARD_ERROR_OF_MEAN|1.744||0.1832|TWO_SIDED|95.0|-5.74|1.1|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Symptoms component, baseline SGRQ Symptoms component-by-visit and random effect for patient.||1.10|-5.74|0.1832
70851714|NCT00893815|141191352|OTHER||Odds Ratio (OR)|0.75||||0.45|TWO_SIDED|95.0|0.35|1.61||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of verbal fluency impairment between HIV-positive and HIV-negative military beneficiaries||1.61|0.35|0.45
70934534|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|80.0|||||TWO_SIDED|95.0|64.0|90.0||||||Adult cohort: percent seropositive to DENV-1 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|64|
71108055|NCT02949011|141721551|SUPERIORITY||Median Difference|-3.6||||0.007||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Feverishness or Chills||||0.0070
71108056|NCT02949011|141721551|SUPERIORITY||Median Difference|-0.7||||0.9191||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Feverishness or Chills||||0.9191
71024566|NCT01335464|141556064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|1.446||0.551|TWO_SIDED|95.0|-1.97|3.7|||Mixed Models Analysis||"Within-patient error are modelled by compound symmetry covariance matrix~Nintedanib 150 mg bid versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ impact component, baseline SGRQ Impact component-by-visit and random effect for patient||3.70|-1.97|0.5510
71024567|NCT01335464|141556065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19|STANDARD_ERROR_OF_MEAN|1.427||0.4049|TWO_SIDED|95.0|-3.99|1.61|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix~Nintedanib 150 mg bid versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Activities component, baseline SGRQ Activities component-by-visit and random effect for patient||1.61|-3.99|0.4049
71024568|NCT01335464|141556066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|1.289||0.5446|TWO_SIDED|95.0|-3.31|1.75|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150mg versus placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ-I Total score, baseline SGRQ-I Total score-by-visit and random effect for patient.||1.75|-3.31|0.5446
71024569|NCT01335464|141556067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|STANDARD_ERROR_OF_MEAN|1.77||0.6203|TWO_SIDED|95.0|-4.35|2.6|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150mg versus placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SOBQ score, baseline SOBQ score-by-visit and random effect for patient.||2.60|-4.35|0.6203
71024570|NCT01335464|141556068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|1.803||0.8942|TWO_SIDED|95.0|-3.78|3.3|||Mixed Models Analysis||"Within- patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline CASA-Q Cough symptoms score, baseline CASA-Q Cough symptoms score-by-visit and random effect for patient.||3.30|-3.78|0.8942
71024571|NCT01335464|141556069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.64|STANDARD_ERROR_OF_MEAN|1.596||0.3042|TWO_SIDED|95.0|-1.49|4.77|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix~Nintedanib 150 mg versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline CASA-Q Cough impact score, baseline CASA-Q Cough impact score-by-visit and random effect for patient.||4.77|-1.49|0.3042
71024572|NCT01335464|141556070|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.276||||0.1818|TWO_SIDED|95.0|0.89|1.83|||Regression, Logistic||Nintedanib 150mg versus placebo|Logistic regression with term treatment||1.83|0.89|0.1818
71024573|NCT01335464|141556072|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.17||||0.6793|TWO_SIDED|95.0|0.56|2.46|||Normal distribution|Risk ratio was calculated as the ratio of risk of exacerbation in both treatment groups.|Nintedanib 150mg bid versus placebo|The log of the risk ratio was assumed to follow a normal distribution with mean 0 and variance equal to the sum of the reciprocals of the number of patients with at least one exacerbation in each treatment arm.||2.46|0.56|0.6793
71024574|NCT01335464|141556073|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63||||0.288|TWO_SIDED|95.0|0.29|1.36|||Log Rank||Nintedanib 150mg bid versus placebo|Hazard ratio is based on a Cox´s regression model with terms for treatment, gender, age and height||1.36|0.29|0.2880
71024575|NCT01335464|141556074|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.3515|TWO_SIDED|95.0|0.25|1.47|||Log Rank||Nintedanib 150mg versus placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height||1.47|0.25|0.3515
71024576|NCT01335464|141556075|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.4869|TWO_SIDED|95.0|0.26|1.82|||Log Rank||Nintedanib 150mg bid versus placebo|Hazard ratio is based on a Cox´s regression model with terms for treatment, gender, age and height||1.82|0.26|0.4869
71024577|NCT01335464|141556076|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.443|TWO_SIDED|95.0|0.36|1.51|||Log Rank||Nintedanib 150mg versus placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height||1.51|0.36|0.4430
71024578|NCT01335464|141556077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.3558|TWO_SIDED|95.0|0.52|1.25|||Log Rank||Nintedanib 150mg bid versus placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height||1.25|0.52|0.3558
71024579|NCT01335464|141556078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.181||0.1138|TWO_SIDED|95.0|-0.07|0.64|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150mg bid versus placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline SpO2, baseline SpO2-by-visit and random effect for patient.||0.64|-0.07|0.1138
71057217|NCT02933255|141619550|OTHER|||||||0.003||||||The reported p-value is representative of changes in soluble factors at 10 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.003
71057218|NCT02933255|141619550|OTHER|||||||0.004||||||The reported p-value is representative of changes in soluble factors at 20 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||0.004
71057219|NCT02933255|141619550|OTHER|||||||0.004||||||The reported p-value is representative of changes in soluble factors at 20 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.004
71057220|NCT02933255|141619551|OTHER|||||||0.002||||||The reported p-value is representative of changes in TNFα at 4 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||0.002
71057221|NCT02933255|141619551|OTHER|||||||0.042||||||The reported p-value is representative of changes in TNFα at 4 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.042
71057222|NCT02933255|141619551|OTHER|||||||0.233||||||The reported p-value is representative of changes in TNFα at 10 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||0.233
71057223|NCT02933255|141619551|OTHER|||||||0.052||||||The reported p-value is representative of changes in TNFα at 10 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.052
71024580|NCT01335464|141556079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.0896||0.865|TWO_SIDED|95.0|-0.191|0.161|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150mg bid versus placebo"|Mixed Model for Repeated Measures with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline DLCO (HGB Corrected) \[mmol/min/kPa\], baseline DLCO (HGB Corrected) \[mmol/min/kPa\]-by-visit and random effect for patient.||0.161|-0.191|0.8650
71024581|NCT00696709|141556099|OTHER||||||<|0.0001||||||The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is \>1.0.|Longitudinal regression (LR)|Calculated based on LR model (adjusting for pre-vaccination immunogenicity level and incomplete data) with visit as covariate.||||||<0.0001
71024582|NCT00696709|141556100|OTHER||||||<|0.0001||||||The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is \>1.0.|Longitudinal regression (LR)|Calculated based on LR model (adjusting for pre-vaccination immunogenicity level and incomplete data) with visit as covariate.||||||<0.0001
70934535|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|66.0|||||TWO_SIDED|95.0|49.0|79.0||||||Adult cohort: percent seropositive to DENV-1 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||79|49|
70934536|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|66.0|||||TWO_SIDED|95.0|49.0|79.0||||||Adult cohort: percent seropositive to DENV-1 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||79|49|
71024583|NCT00696709|141556101|OTHER||||||<|0.0001||||||The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is \>1.0.|Longitudinal regression (LR)|Calculated based on LR model (adjusting for pre-vaccination immunogenicity level and incomplete data) with visit as covariate.||||||<0.0001
71024584|NCT00696709|141556102|OTHER|The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is \>1.0.|||||<|0.0001|||||||Longitudinal data analysis (LDA)|LDA with log-transformed VZV responses at each visit as response variables and visit as covariate.||||||<0.0001
71024585|NCT00696709|141556103|OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-10.8|5.7|||||Miettinen \& Nurminen|||5.7|-10.8|
71024586|NCT00696709|141556103|OTHER||Difference in Percentage|1.6|||||TWO_SIDED|95.0|-9.2|8.8|||||Miettinen \& Nurminen|||8.8|-9.2|
71024587|NCT00696709|141556104|OTHER||Difference in Percentage|35.9|||<|0.001|TWO_SIDED|95.0|15.2|52.6|||Miettinen & Nurminen|||||52.6|15.2|<0.001
71024588|NCT00696709|141556104|OTHER||Difference in Percentage|40.4|||<|0.001|TWO_SIDED|95.0|19.6|57.0|||Miettinen & Nurminen|||||57.0|19.6|<0.001
71057224|NCT02933255|141619551|OTHER|||||||0.055||||||The reported p-value is representative of changes in TNFα at 20 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||0.055
71057225|NCT02933255|141619551|OTHER|||||||0.203||||||The reported p-value is representative of changes in TNFα at 20 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.203
71057226|NCT02933255|141619551|OTHER||||||<|0.001||||||The reported p-value is representative of changes in IL-10 at 4 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||<0.001
71057227|NCT02933255|141619551|OTHER|||||||0.034||||||The reported p-value is representative of changes in IL-10 at 4 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.034
71024589|NCT00696709|141556105|OTHER||Difference in Percentage|-4.7|||||TWO_SIDED|95.0|-25.3|16.1|||||Miettinen \& Nurminen|||16.1|-25.3|
71024590|NCT00696709|141556105|OTHER||Difference in Percentage|4.1|||||TWO_SIDED|95.0|-16.9|24.9|||||Miettinen \& Nurminen|||24.9|-16.9|
71024591|NCT00696709|141556106|OTHER||Difference in Percentage|1.6||||0.48|TWO_SIDED|95.0|-9.3|8.4|||Miettinen & Nurminen|||||8.4|-9.3|0.480
71024592|NCT00696709|141556106|OTHER||Difference in Percentage|1.6||||0.469|TWO_SIDED|95.0|-9.2|8.8|||Miettinen & Nurminen|||||8.8|-9.2|0.469
71024593|NCT00696709|141556107|OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-10.8|5.7|||||Miettinen \& Nurminen|||5.7|-10.8|
71024594|NCT00696709|141556107|OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-10.8|6.0|||||Miettinen \& Nurminen|||6.0|-10.8|
71024595|NCT01033864|141556113|SUPERIORITY_OR_OTHER|||||||0.8055|||||||Wilcoxon (Mann-Whitney)|||||||0.8055
71024596|NCT01033864|141556114|SUPERIORITY_OR_OTHER|||||||0.2548|||||||Wilcoxon (Mann-Whitney)|||||||0.2548
71057228|NCT02933255|141619551|OTHER||||||<|0.001||||||The reported p-value is representative of changes in IL-10 at 10 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||<0.001
71057229|NCT02933255|141619551|OTHER|||||||0.034||||||The reported p-value is representative of changes in IL-10 at 10 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.034
71057230|NCT02933255|141619551|OTHER|||||||0.004||||||The reported p-value is representative of changes in IL-10 at 20 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||0.004
71057231|NCT02933255|141619551|OTHER|||||||0.129||||||The reported p-value is representative of changes in IL-10 at 20 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.129
71057232|NCT02933255|141619553|OTHER|||||||0.339||||||The reported p-value is representative of changes in CD4+ T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.339
71057233|NCT02933255|141619553|OTHER|||||||0.037||||||The reported p-value is representative of changes in CD4+ T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.037
71057234|NCT02933255|141619553|OTHER|||||||0.009||||||The reported p-value is representative of changes in CD4+ T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.009
71057235|NCT02933255|141619553|OTHER|||||||0.844||||||The reported p-value is representative of changes in CD4+ T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.844
71057236|NCT02933255|141619553|OTHER|||||||0.204||||||The reported p-value is representative of changes in CD8+ T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.204
71057237|NCT02933255|141619553|OTHER|||||||0.084||||||The reported p-value is representative of changes in CD8+ T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.084
71057238|NCT02933255|141619553|OTHER|||||||0.042||||||The reported p-value is representative of changes in CD8+ T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.042
71057239|NCT02933255|141619553|OTHER|||||||0.688||||||The reported p-value is representative of changes in CD8+ T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.688
71057240|NCT02933255|141619553|OTHER||||||<|0.001||||||The reported p-value is representative of changes in Treg cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||<0.001
71057241|NCT02933255|141619553|OTHER|||||||0.733||||||The reported p-value is representative of changes in Treg cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.733
71057242|NCT02933255|141619553|OTHER|||||||0.519||||||The reported p-value is representative of changes in Treg cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.519
71108057|NCT02949011|141721551|SUPERIORITY||Median Difference|-7.7||||0.0232||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Muscle or Joint Pain||||0.0232
71057243|NCT02933255|141619553|OTHER|||||||0.695||||||The reported p-value is representative of changes in Treg cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.695
71057244|NCT02933255|141619553|OTHER|||||||0.034||||||The reported p-value is representative of changes in cDC cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.034
71108058|NCT02949011|141721551|SUPERIORITY||Median Difference|4.0||||0.5436||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Muscle or Joint Pain||||0.5436
71057245|NCT02933255|141619553|OTHER|||||||0.301||||||The reported p-value is representative of changes in cDC cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.301
71057246|NCT02933255|141619553|OTHER|||||||0.38||||||The reported p-value is representative of changes in cDC cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.38
71057247|NCT02933255|141619553|OTHER|||||||0.014||||||The reported p-value is representative of changes in cDC cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.014
71057248|NCT02933255|141619553|OTHER|||||||0.791||||||The reported p-value is representative of changes in monocytes at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.791
71057249|NCT02933255|141619553|OTHER|||||||0.042||||||The reported p-value is representative of changes in monocytes at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.042
71057250|NCT02933255|141619553|OTHER|||||||0.424||||||The reported p-value is representative of changes in monocytes at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.424
71057251|NCT02933255|141619553|OTHER|||||||0.77||||||The reported p-value is representative of changes in monocytes at week 10 post treatment compared to baseline in the lead-in neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.77
71057252|NCT02933255|141619553|OTHER|||||||0.001||||||The reported p-value is representative of changes in CD4+ki67+ T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.001
71057253|NCT02933255|141619553|OTHER|||||||0.105||||||The reported p-value is representative of changes in CD4+ki67+ T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.105
71057254|NCT02933255|141619553|OTHER|||||||0.622||||||The reported p-value is representative of changes in CD4+ki67+ T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.622
71057255|NCT02933255|141619553|OTHER|||||||0.313||||||The reported p-value is representative of changes in CD4+ki67+ T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.313
71057256|NCT02933255|141619553|OTHER||||||<|0.001||||||The reported p-value is representative of changes in CD4+ EM ki67+ T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||<0.001
71057257|NCT02933255|141619553|OTHER|||||||0.049||||||The reported p-value is representative of changes in CD4+ EM ki67+ T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.049
71057258|NCT02933255|141619553|OTHER|||||||0.47||||||The reported p-value is representative of changes in CD4+ EM ki67+ T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.47
71057259|NCT02933255|141619553|OTHER|||||||0.313||||||The reported p-value is representative of changes in CD4+ EM ki67+ T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.313
70934537|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|69.0|||||TWO_SIDED|95.0|52.0|81.0||||||Adult cohort: percent seropositive to DENV-2 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||81|52|
70934538|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|94.0|||||TWO_SIDED|95.0|81.0|98.0||||||Adult cohort: percent seropositive to DENV-2 at stud day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||98|81|
70934539|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adult cohort: percent seropositive to DENV-2 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
70934540|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|74.0|95.0||||||Adult cohort: percent seropositive to DENV-2 at study day 180. There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||95|74|
70934541|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|74.0|95.0||||||Adult cohort: percent seropositive to DENV-2 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||95|74|
70934542|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|91.0|||||TWO_SIDED|95.0|78.0|97.0||||||Adult cohort: percent seropositive to DENV-2 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
70934543|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|86.0|||||TWO_SIDED|95.0|71.0|94.0||||||Adult cohort: percent seropositive to DENV-2 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
71024597|NCT01033864|141556115|SUPERIORITY_OR_OTHER|||||||0.4417|||||||Wilcoxon (Mann-Whitney)|||||||0.4417
71024598|NCT01033864|141556116|SUPERIORITY_OR_OTHER|||||||0.0455|||||||Wilcoxon (Mann-Whitney)|||||||0.0455
71057260|NCT02933255|141619553|OTHER|||||||0.001||||||The reported p-value is representative of changes in CD4+ ICOS+ T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.001
71057261|NCT02933255|141619553|OTHER|||||||0.092||||||The reported p-value is representative of changes in CD4+ ICOS+ T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.092
70934544|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|71.0|||||TWO_SIDED|95.0|55.0|84.0||||||Adult cohort: percent seropositive to DENV-3 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|55|
71024599|NCT01033864|141556117|SUPERIORITY_OR_OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||||||0.2300
70934545|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|94.0|||||TWO_SIDED|95.0|81.0|98.0||||||Adult cohort: percent seropositive to DENV-3 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||98|81|
70934546|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|91.0|||||TWO_SIDED|95.0|78.0|97.0||||||Adult cohort: percent seropositive to DENV-3 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
71024600|NCT01033864|141556118|SUPERIORITY_OR_OTHER|||||||0.0106|||||||Wilcoxon (Mann-Whitney)|||||||0.0106
71024601|NCT01033864|141556119|SUPERIORITY_OR_OTHER|||||||0.3401|||||||Wilcoxon (Mann-Whitney)|||||||0.3401
71108059|NCT02949011|141721551|SUPERIORITY||Median Difference|-7.5||||0.0207||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Fatigue||||0.0207
71024602|NCT01033864|141556120|SUPERIORITY_OR_OTHER|||||||0.0074|||||||Wilcoxon (Mann-Whitney)|||||||0.0074
71057262|NCT02933255|141619553|OTHER|||||||0.176||||||The reported p-value is representative of changes in CD4+ ICOS+ T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.176
71057263|NCT02933255|141619553|OTHER|||||||0.232||||||The reported p-value is representative of changes in CD4+ ICOS+ T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.232
71057264|NCT02933255|141619553|OTHER||||||<|0.001||||||The reported p-value is representative of changes in CD8+ ki67+ T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||<0.001
71108060|NCT02949011|141721551|SUPERIORITY||Median Difference|-1.9||||0.371||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Fatigue||||0.3710
71024603|NCT01033864|141556121|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Wilcoxon (Mann-Whitney)|||||||0.0002
71024604|NCT00926289|141556134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.5|||<|0.0001||95.0|-10.6|-6.4|||ANCOVA|Fixed effects of treatment, week, treatment-by-week interaction, country with the continuous covariates of baseline and baseline-by-week interaction||T80+HCTZ25 versus T80 monotherapy||-6.4|-10.6|<0.0001
71024605|NCT00926289|141556135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.3|||<|0.0001||95.0|-9.3|-5.2|||ANCOVA|Fixed effects of treatment, week, treatment-by-week interaction, country with the continuous covariates of baseline and baseline-by-week interaction||T80+HCTZ25 versus T80 monotherapy||-5.2|-9.3|<0.0001
71057265|NCT02933255|141619553|OTHER|||||||0.131||||||The reported p-value is representative of changes in CD8+ ki67+ T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.131
70934547|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|74.0|95.0||||||Adult cohort: percent seropositive to DENV-3 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||95|74|
70934548|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|86.0|||||TWO_SIDED|95.0|71.0|94.0||||||Adult cohort: percent seropositive to DENV-3 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
70934549|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|74.0|95.0||||||Adult cohort: percent seropositive to DENV-3 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||95|74|
71024606|NCT00926289|141556136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.8|||<|0.0001||95.0|-8.8|-4.7|||ANCOVA|Fixed effects of treatment, week, treatment-by-week interaction, country with the continuous covariates of baseline and baseline-by-week interaction||T80+HCTZ25 versus T80 monotherapy||-4.7|-8.8|<0.0001
71024607|NCT00926289|141556137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2|||<|0.0001||95.0|-4.5|-1.9|||ANCOVA|Fixed effects of treatment, week, treatment-by-week interaction, country with the continuous covariates of baseline and baseline-by-week interaction||T80+HCTZ25 versus T80 monotherapy||-1.9|-4.5|<0.0001
71024608|NCT00926289|141556138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.36|||<|0.0001||95.0|1.74|3.21|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||3.21|1.74|<0.0001
71024609|NCT00926289|141556139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.0001||95.0|1.7|3.12|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||3.12|1.70|<0.0001
71024610|NCT00926289|141556140|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19|||<|0.0001||95.0|1.6|3.01|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||3.01|1.60|<0.0001
71024611|NCT00926289|141556141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0|||<|0.0001||95.0|1.46|2.73|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||2.73|1.46|<0.0001
71024612|NCT00926289|141556142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.02|||<|0.0001||95.0|1.48|2.76|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||2.76|1.48|<0.0001
71057266|NCT02933255|141619553|OTHER|||||||0.424||||||The reported p-value is representative of changes in CD8+ ki67+ T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.424
71057267|NCT02933255|141619553|OTHER|||||||0.438||||||The reported p-value is representative of changes in CD8+ ki67+ T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.438
70934550|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|80.0|||||TWO_SIDED|95.0|64.0|90.0||||||Adult cohort: percent seropositive to DENV-3 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|64|
70934551|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|20.0|||||TWO_SIDED|95.0|10.0|36.0||||||Adult cohort: percent seropositive to DENV-4 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||36|10|
71024613|NCT00926289|141556143|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74||||0.0005||95.0|1.28|2.37|||Regression, Logistic|Adjustment for continuous covariate of baseline and fixed effect country||T80+HCTZ25 versus T80 monotherapy||2.37|1.28|0.0005
71024614|NCT00926289|141556144|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39|||<|0.0001||95.0|1.76|3.26|||Regression, Logistic|Adjustment for continuous covariate of baseline (SBP), treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||3.26|1.76|<0.0001
71024615|NCT00926289|141556145|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.42|||<|0.0001||95.0|1.78|3.29|||Regression, Logistic|Adjustment for continuous covariate of baseline (DBP), treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||3.29|1.78|<0.0001
71024616|NCT00926289|141556146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.62|||<|0.0001||95.0|1.7|4.04|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||4.04|1.70|<0.0001
71024617|NCT00926289|141556147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.23|||<|0.0001||95.0|1.57|3.16|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||3.16|1.57|<0.0001
71024618|NCT00926289|141556148|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren test stratified for country|||T80+HCTZ25 versus T80 monotherapy||||<0.0001
71024619|NCT02668302|141556157|SUPERIORITY|||||||0.4709|||||||t-test, 2 sided|P-values from two-sample T-test with equal variance assumption||||||0.4709
71024620|NCT00526890|141556180|OTHER|||||||0.3149|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney-Wilcoxon test was used to test the correlation between selenium levels and serious adverse events.||||0.3149
71057268|NCT02933255|141619553|OTHER||||||<|0.001||||||The reported p-value is representative of changes in Treg ICOS+ cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||<0.001
71057269|NCT02933255|141619553|OTHER|||||||0.151||||||The reported p-value is representative of changes in Treg ICOS+ cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.151
71057270|NCT02933255|141619553|OTHER|||||||0.569||||||The reported p-value is representative of changes in Treg ICOS+ cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.569
71057271|NCT02933255|141619553|OTHER|||||||0.105||||||The reported p-value is representative of changes in Treg ICOS+ cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.105
71024621|NCT03529955|141556186|EQUIVALENCE|The student t test (paired) and ANOVA analysis of variance were used to assess the mean change in CDASI, MMT-8, DLQI and to compare the positive cell detection on immunohistochemistry for CCL5, pSTAT1 and pSTAT3 at baseline and 3 months post apremilast. All p values were two-sided, and values \<0.05 were considered statistically significant. Analyses were performed using GraphPad Prism 8 (GraphPad Software Inc.). The last observation carried forward approach was used for missing values.||||||0.01||||||The investigators hypothesized that genes identified as significantly differentially expressed between the two groups will have ≥2-fold change at p\<0.01.|ANOVA|||The student t test (paired) and ANOVA analysis of variance were used to assess the mean change in CDASI, MMT-8, DLQI and to compare the positive cell detection on immunohistochemistry for CCL5, pSTAT1 and pSTAT3 at baseline and 3 months post apremilast. All p values were two-sided, and values \<0.05 were considered statistically significant. Analyses were performed using GraphPad Prism 8 (GraphPad Software Inc.). The last observation carried forward approach was used for missing values.||||0.01
71024622|NCT03740100|141556190|OTHER||Percent with objective response|17.0|||||TWO_SIDED|95.0|1.0|58.0||||||The primary endpoint was to determine the objective response rate of patients with R/M HNSCC harboring NOTCH1 LOF mutations to oral bimiralisib using RECIST v1.1. We used a Simon's optimal two-stage design. In order to have 80% power to detect a response rate of 30%, (one-sided α=0.05 and β=0.20), we planned to enroll up to 10 patients in the first stage. If ≥ 2 patients had an objective response, then the study would enroll an additional 19 patients in the second stage.||58|1|
71024623|NCT00982410|141556211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6489|STANDARD_ERROR_OF_MEAN|0.29|<|0.05|TWO_SIDED|95.0|-1.2255|-0.0722|||Mixed Models Analysis|Adjusted for baseline NRS-1 pain level. Time interval and therapy session block were utilized to model the variance.|EUC (Arm 2) was referent. Estimation parameter = value for Cognitive Behavior Treatment group minus value for Educational Support group.|Ho: There was no difference in average pain level across the follow-up period, between CBT group and Educational support group.||-0.07220|-1.2255|<0.05
71024624|NCT00982410|141556212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||<|0.05|TWO_SIDED|95.0|0.034|0.466|||Mixed Models Analysis|Adjusted for baseline WHY MPI General Activity score. Time interval and therapy session block were utilized to model the variance.|Education Support group was referent. Mean difference = value for CBT group minus value for Educational Support group.|||0.466|0.034|<0.05
71024625|NCT00982410|141556213|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline #days of alcohol use. Time interval and therapy session block were utilized to model the variance.||||||<0.01
71024626|NCT00982410|141556214|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline #days illicit drug use. Time interval and therapy session block were utilized to model the variance. EUC group was referent.||||||>0.05
71024627|NCT00982410|141556215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.66|||>|0.05|TWO_SIDED|95.0|-5.0|14.32|||Mixed Models Analysis|Adjusted for baseline pain tolerance. Time interval and therapy session block were utilized to model the variance.|Educational Support group = referent. Estimation parameter = CBT group minus EUC group, adjusted for BL pain tolerance. Cold tolerance distribution had ceiling and floor effects; and, \~20% of participants refused cold tolerance task in follow-up.|||14.32|-5.00|>0.05
71024628|NCT00982410|141556216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.28|||<|0.005|TWO_SIDED|95.0|3.93|16.63|||Mixed Models Analysis|Adjusted for baseline CPSS PSE score. Time interval and therapy session block were utilized to model the variance. EUC group was referent.|Adjusted for baseline CPSS PSE score. EUC group was referent. Mean difference = value for CBT minus value for Educational Support group.|||16.63|3.93|<0.005
71024629|NCT04014959|141556240|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|t(35)= -4.47||Statistical analysis of fMRI-guided TMS evoked subgenual anterior cingulate responses (fMRI BOLD) change at Pre-tx/Pre-iTBS. Statistics are from one-sample T-tests vs. 0, 2-tailed. Negative t-values represent negative mean fMRI BOLD percent signal change. Alternative hypothesis: true mean is not equal to 0.||||<0.001
71057272|NCT02933255|141619553|OTHER|||||||0.012||||||The reported p-value is representative of changes in NK ki67+ cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.012
71024630|NCT04014959|141556240|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|t(35)= -3.00||Statistical analysis of fMRI-guided TMS evoked subgenual anterior cingulate responses (fMRI BOLD) change at Pre-tx/Post-iTBS. Statistics are from one-sample T-tests vs. 0, 2-tailed. Negative t-values represent negative mean fMRI BOLD percent signal change. Alternative hypothesis: true mean is not equal to 0.||||0.005
71024631|NCT04014959|141556240|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|t(35)= -2.96||Statistical analysis of fMRI-guided TMS evoked subgenual anterior cingulate responses (fMRI BOLD) change at Post-tx/Pre-iTBS. Statistics are from one-sample T-tests vs. 0, 2-tailed. Negative t-values represent negative mean fMRI BOLD percent signal change. Alternative hypothesis: true mean is not equal to 0.||||0.005
71024632|NCT04014959|141556240|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|t(35)= -5.05||Statistical analysis of fMRI-guided TMS evoked subgenual anterior cingulate responses (fMRI BOLD) change at Post-tx/Post-iTBS. Statistics are from one-sample T-tests vs. 0, 2-tailed. Negative t-values represent negative mean fMRI BOLD percent signal change. Alternative hypothesis: true mean is not equal to 0.||||<0.001
71024633|NCT04014959|141556242|OTHER|Statistics are an unadjusted linear regression of change in DASS-21 depression score on the pre-intervention TMS/fMRI evoked brain response.||||||0.007|||||||Regression, Linear|β = -33.60||Analysis to investigate the correlation between changes in DASS-21 Scores (Secondary Outcome) and Evoked Functional Brain Activity (Other Pre-specified Outcome) pre and post the 3-Day TMS Intervention Regimen.||||0.007
71057273|NCT02933255|141619553|OTHER|||||||0.677||||||The reported p-value is representative of changes in NK ki67+ cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.677
71057274|NCT02933255|141619553|OTHER|||||||0.424||||||The reported p-value is representative of changes in NK ki67+ cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.424
71108061|NCT02949011|141721552|SUPERIORITY||Median Difference|-23.4||||0.4634||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.4634
71024634|NCT01016652|141556243|NON_INFERIORITY_OR_EQUIVALENCE|This is a non-inferiority analysis, with \>=5 CLUE points being the non-inferiority margin.|Mean Difference (Final Values)|-4.14|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-9.86|1.59|||Mixed Models Analysis|||"Ho: There are not significant differences between the two lenses (etafilcon A multifocal (test) vs. etafilcon A sphere (control)for Vision quality.~Ha: The test lens is greater than or equal by 5 CLUE points than the control lense."||1.59|-9.86|
70934552|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|77.0|||||TWO_SIDED|95.0|61.0|88.0||||||Adult cohort: percent seropositive to DENV-4 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||88|61|
70934553|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|80.0|||||TWO_SIDED|95.0|64.0|90.0||||||Adult cohort: percent seropositive to DENV-4 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|64|
71024635|NCT01016652|141556244|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin will be exceeded if the test lens is greater than or equal to 0.25D over the control lens.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|95.0|-0.09|0.1|||Mixed Models Analysis|||"Ho: There is not a difference between the test lens and the control lens for amplitude of accommodation.~Ha: Monocular amplitude of accommodation of the test lens is significantly better than the control lens"||0.10|-0.09|
71024636|NCT02060461|141556249|OTHER|||||||0.003|||||||t-test, 2 sided|||Paired Students t-test of FS200 and IntraLase intraoperative flap thickness measurements obtained by ultrasound pachymetry||||.003
71024637|NCT02034799|141556250|NON_INFERIORITY_OR_EQUIVALENCE|The assumed proportion of success for SOC is 0.95 and the proportion of success for the Bioseal group at which the power is calculated is 0.95. A sample size of 112 subjects per group achieves 80% power to detect the non-inferiority margin difference between the group proportions of -0.10. One-sided significance level of 0.025 was used. Using drop-out rate of 10%, 125 subjects per treatment group were randomized for a total of 250 subjects.|Risk Difference (RD)|0.0781|||||TWO_SIDED|95.0|-0.048|0.199||||||H0: Delta \</= -0.1 HA: Delta \> -0.1 Delta is difference in proportion of successes between Bioseal and SOC gropus (Bioseal minus SOC). Success is defined as hemostasis at the TBS at 6 minutes following treatment application||0.199|-0.048|
71024638|NCT05321810|141556259|OTHER|||||||0.016|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||0.016
71024639|NCT05321810|141556264|OTHER||Hazard Ratio (HR)|0.812||||0.013|TWO_SIDED|95.0|0.69|0.957|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|0.957|0.690|0.013
71024640|NCT05321810|141556270|OTHER|||||||0.002|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||0.002
71024641|NCT05321810|141556273|OTHER||||||<|0.001|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||<0.001
71024642|NCT05321810|141556274|OTHER||Hazard Ratio (HR)|0.57|||<|0.001|TWO_SIDED|95.0|0.42|0.773|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|0.773|0.420|<0.001
71108062|NCT02949011|141721552|SUPERIORITY||Median Difference|-0.6||||0.6386||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.6386
71108063|NCT02949011|141721553|SUPERIORITY|||||||0.0112||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact|||||||0.0112
70934554|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|74.0|||||TWO_SIDED|95.0|58.0|86.0||||||Adult cohort: percent seropositive to DENV-4 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||86|58|
70934555|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|66.0|||||TWO_SIDED|95.0|49.0|79.0||||||Adult cohort: percent seropositive to DENV-4 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||79|49|
70934556|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|60.0|||||TWO_SIDED|95.0|44.0|74.0||||||Adult cohort: percent seropositive to DENV-4 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||74|44|
71024643|NCT05321810|141556276|OTHER|||||||0.35|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||0.350
71024644|NCT05321810|141556277|OTHER||Hazard Ratio (HR)|1.155||||0.324|TWO_SIDED|95.0|0.867|1.54|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|1.540|0.867|0.324
71024645|NCT05321810|141556279|OTHER|||||||0.111|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||0.111
71024646|NCT05321810|141556280|OTHER||Hazard Ratio (HR)|0.866||||0.1|TWO_SIDED|95.0|0.73|1.028|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|1.028|0.730|0.100
71108064|NCT02949011|141721553|SUPERIORITY|||||||0.8478||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact|||||||0.8478
71108065|NCT02949011|141721554|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact|||Any Complications||||<0.0001
71024647|NCT05321810|141556282|OTHER|||||||0.979|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||0.979
71024648|NCT05321810|141556283|OTHER||Hazard Ratio (HR)|1.002||||0.978|TWO_SIDED|95.0|0.854|1.177|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|1.177|0.854|0.978
71024649|NCT05321810|141556285|OTHER||||||<|0.001|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||<0.001
71024650|NCT05321810|141556286|OTHER||Hazard Ratio (HR)|0.428|||<|0.001|TWO_SIDED|95.0|0.263|0.697|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|0.697|0.263|<0.001
71024651|NCT05321810|141556290|OTHER||Hazard Ratio (HR)|0.727||||0.001|TWO_SIDED|95.0|0.599|0.881|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|0.881|0.599|0.001
71024652|NCT00434161|141556305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.679||||0.188|TWO_SIDED|97.5|0.351|1.313||A 2.5% type I error rate for each comparison gives an overall type I error rate of 5%.|Proportional odds model|The proportional odds model including the randomization factors as covariates was used for the primary endpoint, maximum severity of OM.|The odds ratio was defined to be the odds of a subject receiving placebo experiencing OM divided by the odds of a subject receiving palifermin developing OM.|The null hypothesis was that the severity distribution for OM was identical for the placebo and each of the two palifermin groups, and the alternative hypothesis was that palifermin resulted in a shift in the distribution to less severe mucositis than placebo. A total of 275 subjects would give at least 95% power, with a 2.5% type I error rate for each comparison to detect an odds ratio of at least 3.5 between the placebo group and each of the two palifermin groups.||1.313|0.351|0.188
71024653|NCT00434161|141556305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.242||||0.468|TWO_SIDED|97.5|0.635|2.431||A 2.5% type I error rate for each comparison gives an overall type I error rate of 5%.|Proportional odds model|The proportional odds model including the randomization factors as covariates was used for the primary endpoint, maximum severity of OM.|The odds ratio was defined to be the odds of a subject receiving placebo experiencing OM divided by the odds of a subject receiving palifermin developing OM.|The null hypothesis was that the severity distribution for OM was identical for the placebo and each of the two palifermin groups, and the alternative hypothesis was that palifermin resulted in a shift in the distribution to less severe mucositis than placebo. A total of 275 subjects would give at least 95% power, with a 2.5% type I error rate for each comparison to detect an odds ratio of at least 3.5 between the placebo group and each of the two palifermin groups.||2.431|0.635|0.468
71024654|NCT00434161|141556306|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.262||||0.245|TWO_SIDED|97.5|-4.303|30.828||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|Cochran-Mantel-Haenszel|||||30.828|-4.303|0.245
71024655|NCT00434161|141556306|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.014||||0.806|TWO_SIDED|97.5|-20.519|16.491||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|Cochran-Mantel-Haenszel|||||16.491|-20.519|0.806
71024656|NCT00434161|141556307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.409|STANDARD_DEVIATION|6.82||0.095|TWO_SIDED|97.5|0.07|4.748||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|van Elteren test|||A type I error rate was protected by using the Hochberg procedure to adjust for multiple testing. Palifermin was not to be declared to be statistically superior to placebo with respect to secondary efficacy endpoints unless the primary endpoint was statistically significant in favor of palifermin.||4.748|0.070|0.095
70934557|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|63.0|||||TWO_SIDED|95.0|46.0|77.0||||||Adult cohort: percent seropositive to DENV-4 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||77|46|
70934558|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|26.0|||||TWO_SIDED|95.0|14.0|42.0||||||Adolescent cohort: percent seropositive to DENV-1 a study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||42|14|
71024657|NCT00434161|141556307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.213|STANDARD_DEVIATION|6.13||0.806|TWO_SIDED|97.5|-2.575|2.15||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|van Elteren test|||||2.150|-2.575|0.806
71024658|NCT00434161|141556308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.436||||0.142|TWO_SIDED|97.5|-1.542|32.415||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|van Elteren test|||For the secondary endpoints, the type I error rate was protected by using the Hochberg procedure to adjust for multiple testing16. Palifermin was not to be declared to be statistically superior to placebo with respect to secondary efficacy endpoints unless the primary endpoint was statistically significant in favor of palifermin.||32.415|-1.542|0.142
71024659|NCT00434161|141556308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.331||||0.806|TWO_SIDED|97.5|-11.82|22.482||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|van Elteren test|||||22.482|-11.820|0.806
70934559|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|74.0|||||TWO_SIDED|95.0|58.0|86.0||||||Adolescent cohort: percent seropositive to DENV-1 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||86|58|
71024660|NCT00434161|141556309|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.88|||||TWO_SIDED|95.0|-21.669|33.43||According to statistical analysis plan it was not planned to calculate any P-Value.||||||33.43|-21.669|
71024661|NCT00434161|141556311|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.023|||||TWO_SIDED|95.0|-0.134|0.181||||||||0.181|-0.134|
71024662|NCT00434161|141556312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|||||TWO_SIDED|95.0|-0.138|0.26||||||||0.260|-0.138|
71024663|NCT00434161|141556313|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.689|||||TWO_SIDED|95.0|-21.641|14.264||||||||14.264|-21.641|
71024664|NCT00434161|141556314|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.951|||||TWO_SIDED|95.0|-0.679|12.58||||||||12.580|-0.679|
71024665|NCT00434161|141556316|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.192|TWO_SIDED|95.0|0.33|1.26|||Log Rank|||All comparisons for the long-term safety endpoints were based on the combined palifermin group (pre- and post- high dose chemotherapy and pre-high dose chemotherapy only) versus placebo (placebo over palifermin). Overall survival was analyzed using the Kaplan-Meier method. Kaplan-Meier estimates were provided together with the 95% confidence interval.||1.26|0.33|0.192
71024666|NCT00434161|141556317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.417|||||TWO_SIDED|95.0|-11.086|45.919||||||||45.919|-11.086|
71024667|NCT00434161|141556318|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.236|TWO_SIDED|95.0|0.55|1.16|||Log Rank|||All comparisons for the long-term safety endpoints were based on the combined palifermin group (pre- and post- high dose chemotherapy and pre-high dose chemotherapy only) versus placebo (placebo over palifermin). Overall survival was analyzed using the Kaplan-Meier method. Kaplan-Meier estimates were provided together with the 95% confidence interval.||1.16|0.55|0.236
71024668|NCT00434161|141556319|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.84||||0.372|TWO_SIDED|95.0|0.58|1.23|||Log Rank|||All comparisons for the long-term safety endpoints were based on the combined palifermin group (pre- and post- high dose chemotherapy and pre-high dose chemotherapy only) versus placebo (placebo over palifermin). Overall survival was analyzed using the Kaplan-Meier method. Kaplan-Meier estimates were provided together with the 95% confidence interval.||1.23|0.58|0.372
71024669|NCT01387282|141556321|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon rank sum test|||Superiority analysis||||< 0.0001
71024670|NCT01387282|141556322|SUPERIORITY_OR_OTHER|||||||0.648|||||||Wilcoxon rank sum test|||Superiority analysis||||0.6480
71024671|NCT01387282|141556323|SUPERIORITY_OR_OTHER|||||||0.0016|||||||Mixed Models Analysis|||Superiority analysis||||0.0016
71024672|NCT01387282|141556324|SUPERIORITY_OR_OTHER|||||||0.8637|||||||Mixed Models Analysis|||Superiority analysis||||0.8637
71057275|NCT02933255|141619553|OTHER|||||||0.432||||||The reported p-value is representative of changes in NK ki67+ cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.432
71024673|NCT01387282|141556325|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||Superiority analysis||||< 0.0001
71024674|NCT01267266|141556326|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Log Rank|||||||0.20
71024675|NCT01828255|141556341|OTHER||||||<|0.005|||||||t-test, 2 sided|||||||<0.005
71024676|NCT00789802|141556370|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.03
71024677|NCT00789802|141556370|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.02
71024678|NCT00387712|141556379|OTHER|Analysis of variance between groups across time is the primary analyses.||||||0.001||||||Group (high velocity training vs. low velocity duration training) by time (baseline to post-6 months) for the primary outcome category (peak fitness) using repeated measures analysis of variance. No adjustment for multiple comparisons is needed.|ANOVA|No other adjustments such as degrees of freedom was necessary.||"Power Calculation: It was calculated that 29 subjects should be randomized to 2 groups to achieve a significant time by group interaction for peak fitness for high-velocity or low velocity duration training groups, assuming a power of 90 percent power and alpha = 0.01, two-tailed analyses.~Primary analyses is a group by time analysis of variance in peak fitness levels between the higher-intensity and lower intensity training groups across baseline to 6 months post-exercise time points."||||0.001
71024679|NCT00387712|141556380|OTHER|Primary analyses is a group by time analysis of variance in myosin heavy chain levels levels between the higher-intensity and lower intensity training groups across baseline to 6 months post-exercise time points.||||||0.11|||||||ANOVA|||Power Calculation: It was calculated that 22 participants should be randomized to 2 groups to achieve a significant time by group interaction for myosin heavy chain isoforms for high-velocity or low velocity duration training groups, assuming a power of 90 percent power and alpha = 0.01, two-tailed analyses.||||0.11
71024680|NCT00387712|141556381|OTHER|Analysis of variance between groups across time is the primary analyses.||||||0.81||||||Group (high velocity training vs. low velocity duration training) by time (baseline to post-6 months) for the secondary outcome category (30 ft walk time - fastest comfortable gait) using repeated measures analysis of variance.|ANOVA|No other adjustments such as degrees of freedom was necessary.||Primary analyses is a group by time analysis of variance in 30 foot walk time (sec) between the higher-intensity and lower intensity training groups across baseline to 6 months post-exercise time points.||||0.81
71024681|NCT00322309|141556387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_DEVIATION|2.6|>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||It was hypothesized that there would be no significant difference between the two treatment groups for benzoylecgonine data collected for Week 11.||||>0.05
71024682|NCT00322309|141556388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8|STANDARD_DEVIATION|6.6|>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||It was hypothesized that means scores for the CGI-O would not differ significantly for these values obtained in the final treatment week, Week 11.||||>0.05
71024683|NCT00322309|141556389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|5.4|>|0.05|TWO_SIDED|||||This analysis involves a between group comparison.|t-test, 2 sided|||It hypothesized that the two treatment groups would not differ significantly with respect to the total HAM-D scores obtained in the final week of the study (Week 11).||||>0.05
71057276|NCT02933255|141619553|OTHER|||||||0.016||||||The reported p-value is representative of changes in NK NKG2D+ cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.016
71057277|NCT02933255|141619553|OTHER|||||||0.733||||||The reported p-value is representative of changes in NK NKG2D+ cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.733
71057278|NCT02933255|141619553|OTHER|||||||0.519||||||The reported p-value is representative of changes in NK NKG2D+ cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.519
70934560|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|71.0|||||TWO_SIDED|95.0|55.0|84.0||||||Adolescent cohort: percent seropositive to DENV-1 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|55|
71024684|NCT00322309|141556390|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|18.0|>|0.05||95.0||||Percent of capsules administered does not differ significantly between the two groups.|t-test, 2 sided|||It was hypothesized that there would be no significant difference in the mean percentage of capsules of those dispensed between the two groups.||||>0.05
71024685|NCT00322309|141556391|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|8.5|>|0.05||95.0|||||t-test, 2 sided|||It was hypothesized that there would not be a significant difference between the two groups in the mean percent of urines positive for riboflavin.||||>0.05
71024686|NCT02449291|141556393|SUPERIORITY|||||||0.016|ONE_SIDED|95.0||||One-sided p-value. After adjustment for multiplicity using Hommel's method. (Note: unadjusted p value = 0.016) A priori threshold for statistical significance = 0.025.|Chi-squared|||The primary efficacy analysis was a comparison of the incidence of the primary efficacy variable between the two groups that received APD421 and the group that received placebo, using Pearson's χ2 test. The threshold for determining statistical significance in the comparison of incidence of success between the active and placebo groups (the primary efficacy analysis) was a p-value of 2.5% one-sided.||||0.016
71024687|NCT02449291|141556393|SUPERIORITY|||||||0.016||||||One-sided p-value. After adjustment for multiplicity using Hommel's method. (Note: unadjusted p value = 0.015) A priori threshold for statistical significance = 0.025.|Chi-squared|||The primary efficacy analysis was a comparison of the incidence of the primary efficacy variable between the two groups that received APD421 and the group that received placebo, using Pearson's χ2 test. The threshold for determining statistical significance in the comparison of incidence of success between the active and placebo groups (the primary efficacy analysis) was a p-value of 2.5% one-sided.||||0.016
71024688|NCT02449291|141556394|SUPERIORITY|||||||0.009||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.009
71024689|NCT02449291|141556394|SUPERIORITY|||||||0.002||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.002
71024690|NCT02449291|141556395|SUPERIORITY|||||||0.17||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.170
71024691|NCT02449291|141556395|SUPERIORITY|||||||0.552||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.552
71024692|NCT02449291|141556396|SUPERIORITY|||||||0.003|||||||Regression, Cox|||||||0.003
71024693|NCT02449291|141556396|SUPERIORITY||||||<|0.001|||||||Regression, Cox|||||||<0.001
71024694|NCT02449291|141556397|SUPERIORITY|||||||0.209|||||||Chi-squared|||||||0.209
71024695|NCT02449291|141556397|SUPERIORITY|||||||0.44|||||||Chi-squared|||||||0.440
71024696|NCT02449291|141556398|SUPERIORITY|||||||0.009|||||||Chi-squared|||||||0.009
71024697|NCT02449291|141556398|SUPERIORITY|||||||0.009|||||||Chi-squared|||||||0.009
71024698|NCT02449291|141556399|SUPERIORITY|||||||0.115|||||||Chi-squared|||||||0.115
71024699|NCT02449291|141556399|SUPERIORITY|||||||0.222|||||||Chi-squared|||||||0.222
71024700|NCT02449291|141556400|SUPERIORITY|||||||0.474|||||||Chi-squared|||||||0.474
71024701|NCT02449291|141556400|SUPERIORITY|||||||0.505|||||||Chi-squared|||||||0.505
71024702|NCT02449291|141556401|SUPERIORITY|||||||0.103|||||||Wilcoxon (Mann-Whitney)|||||||0.103
71024703|NCT02449291|141556401|SUPERIORITY|||||||0.166|||||||Wilcoxon (Mann-Whitney)|||||||0.166
71024704|NCT02449291|141556402|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
71024705|NCT02449291|141556402|SUPERIORITY|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||||||0.029
71024706|NCT01492582|141556412|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.74|||||ONE_SIDED||||||||GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"||||
71024707|NCT01492582|141556412|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.76|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
71024708|NCT01492582|141556412|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|2.15|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
71024709|NCT01492582|141556412|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.0|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
71057279|NCT02933255|141619553|OTHER|||||||0.557||||||The reported p-value is representative of changes in NK NKG2D+ cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.557
71057280|NCT02933255|141619553|OTHER|||||||0.034||||||The reported p-value is representative of changes in NK NKp46+ cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.034
71057281|NCT02933255|141619553|OTHER|||||||0.092||||||The reported p-value is representative of changes in NK NKp46+ cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.092
71057282|NCT02933255|141619553|OTHER|||||||0.733||||||The reported p-value is representative of changes in NK NKp46+ cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.733
71024710|NCT01492582|141556412|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.52|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
71024711|NCT01492582|141556412|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.48|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
71024712|NCT01492582|141556412|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|2.48|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
71024713|NCT01492582|141556412|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.0|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
71024714|NCT01492582|141556412|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI GMT ratio|1.23|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
71024715|NCT01492582|141556412|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.12|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
71024716|NCT01492582|141556412|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.46|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Men 16-26:~Castellsague X, Giuliano AR, Goldstone S, et al. Immunogenicity and safety of the 9-valent HPV vaccine in men. Vaccine. 2015;33(48):6892-6901. (HM data)."|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
71024717|NCT01492582|141556412|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.61|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
71024718|NCT01492582|141556412|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.39|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
71057283|NCT02933255|141619553|OTHER|||||||0.922||||||The reported p-value is representative of changes in NK NKp46+ cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.922
71057284|NCT02933255|141619553|OTHER|||||||0.176||||||The reported p-value is representative of changes in CD8+ naive T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.176
71057285|NCT02933255|141619553|OTHER|||||||0.049||||||The reported p-value is representative of changes in CD8+ naive T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.049
71057286|NCT02933255|141619553|OTHER|||||||0.001||||||The reported p-value is representative of changes in CD8+ naive T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.001
71057287|NCT02933255|141619553|OTHER|||||||0.563||||||The reported p-value is representative of changes in CD8+ naive T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.563
71057288|NCT02933255|141619553|OTHER|||||||0.012||||||The reported p-value is representative of changes in CD8+ CM T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.012
71057289|NCT02933255|141619553|OTHER|||||||0.084||||||The reported p-value is representative of changes in CD8+ CM T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.084
71108066|NCT02949011|141721554|SUPERIORITY|||||||0.2558||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact|||Any Complications||||0.2558
71108067|NCT00163189|141721556|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Student's paired t-test|||Month 36||||<0.001
71108068|NCT00163189|141721557|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|||||||Student's paired t-test|||Month 36||||0.008
71108069|NCT01008618|141721602|SUPERIORITY_OR_OTHER|||||||0.0846|||||||Log Rank|||||||0.0846
70934561|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|71.0|||||TWO_SIDED|95.0|55.0|84.0||||||Adolescent cohort: percent seropositive to DENV-1 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|55|
71024719|NCT01492582|141556412|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.1|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
71024720|NCT01492582|141556412|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.65|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Men 16-26:~Castellsague X, Giuliano AR, Goldstone S, et al. Immunogenicity and safety of the 9-valent HPV vaccine in men. Vaccine. 2015;33(48):6892-6901. (HM data)."|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
71024721|NCT01492582|141556412|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|-0.44|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
71024722|NCT01492582|141556413|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||Injection site - Pain, any; Injection site - Swelling, any; Injection site - Erythema, any; Systemic - Nausea Historical Healthy Population: Reported from Gardasil Package Insert 04/2015, Tables 1, 2, 5, and 6||||<0.001
71024723|NCT01492582|141556413|SUPERIORITY|||||||0.03|||||||Chi-squared, Corrected|||Systemic - Fever Historical Healthy Population: Reported from Gardasil Package Insert 04/2015, Tables 1, 2, 5, and 6||||0.03
71024724|NCT01492582|141556413|SUPERIORITY|||||||0.48|||||||Chi-squared, Corrected|||Systemic - Dizziness Historical Healthy Population: Reported from Gardasil Package Insert 04/2015, Tables 1, 2, 5, and 6||||0.48
71024725|NCT01492582|141556413|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||Injection site - Pain, any; Injection site - Swelling, any; Injection site - Erythema, any; Systemic - Nausea; Systemic - Fatigue Historical Healthy Population - As reported by Moreira et. al, 2016, Pediatrics, Table 5||||<0.001
71024726|NCT01492582|141556413|SUPERIORITY|||||||0.07|||||||Chi-squared, Corrected|||Systemic - Headache Historical Healthy Population - As reported by Moreira et. al, 2016, Pediatrics, Table 5||||0.07
71057290|NCT02933255|141619553|OTHER|||||||0.016||||||The reported p-value is representative of changes in CD8+ CM T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.016
71057291|NCT02933255|141619553|OTHER|||||||0.688||||||The reported p-value is representative of changes in CD8+ CM T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.688
71108070|NCT02941614|141721626|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction.|see above|-0.21||||0.92|TWO_SIDED|95.0|-4.48|4.05|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||Data below is for FACT-B 3 month Total Score||4.05|-4.48|0.92
71024727|NCT01492582|141556413|SUPERIORITY|||||||0.28|||||||Chi-squared, Corrected|||Systemic - Fever Historical Healthy Population - As reported by Moreira et. al, 2016, Pediatrics, Table 5||||0.28
71024728|NCT01492582|141556413|SUPERIORITY|||||||0.45|||||||Fisher Exact|||Systemic - Dizziness Historical Healthy Population - As reported by Moreira et. al, 2016, Pediatrics, Table 5||||0.45
71024729|NCT01172600|141556435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.84|TWO_SIDED|95.0|-1.43|1.17|||Regression, Linear|The analysis adjusted for VAS at baseline (before 1st block), number of epidural blocks received, and imbalanced baseline variables.|This is an intention- to-treat analysis. We assigned missing outcomes to 10 patients.|||1.17|-1.43|0.84
71024730|NCT01172600|141556435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.12|TWO_SIDED|95.0|-2.34|0.28|||Regression, Linear||This is a per-protocol analysis, using 68 patients with completed data.|||0.28|-2.34|0.12
71024731|NCT01172600|141556436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.63|TWO_SIDED|98.3|-1.8|1.21|||Mixed Models Analysis|Mixed model with repeated measures, adjusting for VAS pain score at baseline, number of epidural blocks received, and imbalanced baseline variables.|This analysis was per-protocol, using only patients with completed data.|||1.21|-1.80|0.63
71024732|NCT01172600|141556437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.16|TWO_SIDED|98.3|-3.05|0.82|||Mixed Models Analysis|Mixed model with repeated measures, adjusting for VAS pain score at baseline, number of epidural blocks received, and imbalanced baseline variables.|This analysis was per-protocol, using only patients with completed data.|||0.82|-3.05|0.16
71057292|NCT02933255|141619553|OTHER|||||||0.38||||||The reported p-value is representative of changes in gMDSC at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.38
71057293|NCT02933255|141619553|OTHER|||||||0.021||||||The reported p-value is representative of changes in gMDSC at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.021
71057294|NCT02933255|141619553|OTHER|||||||0.91||||||The reported p-value is representative of changes in gMDSC at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.91
71108071|NCT02941614|141721626|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction.|see above|1.37||||0.57|TWO_SIDED|95.0|-3.41|6.15|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for FACT-B 6 month Total Score||6.15|-3.41|0.57
71024733|NCT00909727|141556448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.5|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|6.6|18.3||The primary endpoint and key secondary endpoints were tested in sequence. test 1: primary (α=0.05); test 2: using Hochberg's step-up procedure on weight (Wk 24) and sweat chloride (Wk 24)(α=0.05); test 3: CFQ-R respiratory domain score (Wk 24).|Mixed Models Analysis|Denominator degrees of freedom were estimated using the Kenward-Roger approximation. No imputation of missing data was done.||The primary analysis for the primary efficacy variable was based on a Mixed-Effects Model for Repeated Measures (MMRM). The model included absolute change from baseline in percent predicted forced expiratory volume in 1 second (FEV1) as the dependent variable, treatment (ivacaftor versus placebo) and visit (Day 15, Week 8, Week 16, and Week 24) as fixed effects, and subject as a random effect, with adjustment for the continuous baseline value of percent predicted FEV1.||18.3|6.6|<0.0001
71024734|NCT00909727|141556449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|STANDARD_ERROR_OF_MEAN|2.7||0.0006|TWO_SIDED|95.0|4.5|15.5||There was no adjustment for multiple comparisons.|Mixed Models Analysis|Denominator degrees of freedom were estimated using the Kenward-Roger approximation. no imputation of missing data was done.||Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint, a Mixed-Effects Model for Repeated Measures (MMRM). Estimates were obtained from MMRM with dependent variable absolute change from baseline, fixed effects for categorical visit \& treatment group, \& adjustment for the continuous baseline value of percent predicted FEV1, using unstructured covariance matrix.||15.5|4.5|0.0006
71024735|NCT00909727|141556450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1|STANDARD_ERROR_OF_MEAN|3.7||0.1092|TWO_SIDED|95.0|-1.4|13.5||The primary endpoint and key secondary endpoints were tested in sequence. test 1: primary (α=0.05); test 2: using Hochberg's step-up procedure on weight (Wk 24) and sweat chloride (Wk 24)(α=0.05); test 3: CFQ-R respiratory domain score (Wk 24).|Mixed Models Analysis|||Through Week 24: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint, a Mixed-Effects Model for Repeated Measures (MMRM), with the addition of the baseline domain score as a covariate.||13.5|-1.4|0.1092
71024736|NCT00909727|141556450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|STANDARD_ERROR_OF_MEAN|3.3||0.1354|TWO_SIDED|95.0|-1.6|11.8||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Through Week 48: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint, a Mixed-Effects Model for Repeated Measures (MMRM), with the addition of the baseline domain score as a covariate.||11.8|-1.6|0.1354
71024737|NCT00909727|141556451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-54.3|STANDARD_ERROR_OF_MEAN|3.7|<|0.0001|TWO_SIDED|95.0|-61.8|-46.8||The primary endpoint and key secondary endpoints were tested in sequence. test 1: primary (α=0.05); test 2: using Hochberg's step-up procedure on weight (Wk 24) and sweat chloride (Wk 24)(α=0.05); test 3: CFQ-R respiratory domain score (Wk 24).|Mixed Models Analysis|||Through Week 24: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for sweat chloride and percent predicted forced expiratory volume in 1 second (FEV1), using unstructured covariance matrix.||-46.8|-61.8|<0.0001
71024738|NCT00909727|141556451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-53.5|STANDARD_ERROR_OF_MEAN|3.7|<|0.0001|TWO_SIDED|95.0|-60.9|-46.0||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Through Week 48: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for sweat chloride and percent predicted forced expiratory volume in 1 second (FEV1), using unstructured covariance matrix.||-46.0|-60.9|<0.0001
71024739|NCT00909727|141556452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.5||0.0004|TWO_SIDED|95.0|0.9|2.9||The primary endpoint and key secondary endpoints were tested in sequence. test 1: primary (α=0.05); test 2: using Hochberg's step-up procedure on weight (Wk 24) and sweat chloride (Wk 24)(α=0.05); test 3: CFQ-R respiratory domain score (Wk 24).|Mixed Models Analysis|||At Week 24: Analysis for this variable was based on a Linear Mixed Effect (LME) model with dependent variable weight; treatment as a fixed effect; and intercept, visit, and treatment by visit interaction as random effects, with adjustment for baseline percent predicted forced expiratory volume in 1 second (FEV1) severity.||2.9|0.9|0.0004
71024740|NCT00909727|141556452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|0.7||0.0002|TWO_SIDED|95.0|1.3|4.2||P-value is for the treatment effect at Week 48 (obtained as a linear contrast of treatment at Day 336). There was no adjustment for multiple comparisons.|Mixed Models Analysis|||At Week 48: Analysis for this variable was based on a Linear Mixed Effect (LME) model with random intercept and random slope, treatment as a fixed effect, and visit (days on study) and treatment by visit interaction as random effects, with adjustment for categorical baseline percent predicted forced expiratory volume in 1 second (FEV1) severity.||4.2|1.3|0.0002
71024741|NCT04081337|141556453|SUPERIORITY||LS Mean Difference|19.68||||0.5733|TWO_SIDED|95.0|-50.36|89.72|||ANCOVA|||||89.72|-50.36|0.5733
71024742|NCT04081337|141556454|SUPERIORITY||LS Mean Difference|-855.94|||<|0.0001|TWO_SIDED|95.0|-1090.87|-621.02|||ANCOVA|||||-621.02|-1090.87|<0.0001
71024743|NCT04081337|141556455|SUPERIORITY||LS Mean Difference|-3.22||||0.9481|TWO_SIDED|95.0|-102.65|96.2|||ANCOVA|||||96.20|-102.65|0.9481
71024744|NCT04081337|141556456|SUPERIORITY||LS Mean Difference|-0.034|||<|0.0001|TWO_SIDED|95.0|-0.051|-0.018|||ANCOVA|||||-0.018|-0.051|<0.0001
71024745|NCT04081337|141556457|SUPERIORITY||LS Mean difference|-0.028||||0.0031|TWO_SIDED|95.0|-0.045|-0.01|||ANCOVA|||||-0.010|-0.045|0.0031
71024746|NCT04081337|141556458|SUPERIORITY||LS Mean difference|251.89||||0.0004|TWO_SIDED|95.0|119.09|384.69|||ANCOVA|||||384.69|119.09|0.0004
71108072|NCT02941614|141721626|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|1.18||||0.62|TWO_SIDED|95.0|-3.54|5.89|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is for the Fact-B 12 month Total Score||5.89|-3.54|0.62
70934562|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|69.0|||||TWO_SIDED|95.0|52.0|81.0||||||Adolescent cohort: percent seropositive to DENV-1 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||81|52|
70934563|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|43.0|||||TWO_SIDED|95.0|28.0|59.0||||||Adolescent cohort: percent seropositive to DENV-1 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||59|28|
70934564|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|46.0|||||TWO_SIDED|95.0|30.0|62.0||||||Adolescent cohort: percent seropositive to DENV-1 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||62|30|
70934565|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|34.0|||||TWO_SIDED|95.0|21.0|51.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||51|21|
70934566|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|100.0|||||TWO_SIDED|95.0|90.0|100.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|90|
70934567|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
70934568|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
70934569|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|85.0|||||TWO_SIDED|95.0|71.0|94.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
71108073|NCT02941614|141721626|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction.|see above|0.12||||0.83|TWO_SIDED|95.0|-0.99|1.23|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 3 month Physical Well-Being Subscale||1.23|-0.99|0.83
70934570|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|74.0|||||TWO_SIDED|95.0|58.0|86.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||86|58|
70934571|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|69.0|||||TWO_SIDED|95.0|52.0|81.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||81|52|
70934572|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|37.0|||||TWO_SIDED|95.0|23.0|54.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||54|23|
70934573|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|74.0|95.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||95|74|
70934574|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|94.0|||||TWO_SIDED|95.0|81.0|98.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||98|81|
70934575|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
70934576|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|74.0|95.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||95|74|
71024747|NCT04081337|141556459|SUPERIORITY||LS Mean difference|-6.87||||0.0005|TWO_SIDED|95.0|-10.51|-3.22|||ANCOVA|||For Adjusted protein oxidation||-3.22|-10.51|0.0005
71024748|NCT04081337|141556459|SUPERIORITY||LS Mean difference|14.48|||<|0.0001|TWO_SIDED|95.0|8.02|20.93|||ANCOVA|||For Adjusted fat oxidation||20.93|8.02|<0.0001
71024749|NCT04081337|141556459|SUPERIORITY||LS Mean difference|-26.64||||0.0001|TWO_SIDED|95.0|-39.46|-13.83|||ANCOVA|||Adjusted carbohydrate oxidation||-13.83|-39.46|0.0001
71024750|NCT04081337|141556460|SUPERIORITY||LS Mean difference|-8.47|||<|0.0001|TWO_SIDED|95.0|-11.04|-5.9|||Mixed Models Analysis|||||-5.90|-11.04|<0.0001
71024751|NCT04081337|141556461|SUPERIORITY||LS Mean difference|-4.08|||<|0.0001|TWO_SIDED|95.0|-5.12|-3.05|||Mixed Models Analysis|||||-3.05|-5.12|<0.0001
71024752|NCT04081337|141556462|SUPERIORITY||LS Mean difference|-5.08|||<|0.0001|TWO_SIDED|95.0|-6.93|-3.22|||ANCOVA|||||-3.22|-6.93|<0.0001
71024753|NCT04081337|141556463|SUPERIORITY||LS Mean Difference|-1.14||||0.0304|TWO_SIDED|95.0|-2.16|-0.11|||ANCOVA|||||-0.11|-2.16|0.0304
71024754|NCT04081337|141556464|SUPERIORITY||LS Mean difference|-1.83|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.06|||ANCOVA|||For Triglyceride||-1.06|-2.60|<0.0001
71024755|NCT04081337|141556464|SUPERIORITY||LS Mean difference|-0.84|||<|0.0001|TWO_SIDED|95.0|-1.19|-0.48|||ANCOVA|||For VLDL||-0.48|-1.19|<0.0001
71024756|NCT04081337|141556464|SUPERIORITY||LS Mean difference|-0.53||||0.0436|TWO_SIDED|95.0|-1.05|-0.02|||ANCOVA|||For HDL||-0.02|-1.05|0.0436
71024757|NCT04081337|141556464|SUPERIORITY||LS Mean Difference|0.45||||0.0002|TWO_SIDED|95.0|0.23|0.66|||ANCOVA|||For Free fatty acid||0.66|0.23|0.0002
71024758|NCT04081337|141556465|SUPERIORITY||LS Mean Difference|0.03||||0.8762|TWO_SIDED|95.0|-0.34|0.4|||ANCOVA|||||0.40|-0.34|0.8762
71024759|NCT04081337|141556466|SUPERIORITY||LS Mean difference|3.49||||0.0126|TWO_SIDED|95.0|0.79|6.19|||ANCOVA|||||6.19|0.79|0.0126
71024760|NCT04081337|141556467|SUPERIORITY||LS Mean Difference|-1.26||||0.0222|TWO_SIDED|95.0|-2.34|-0.19|||ANCOVA|||||-0.19|-2.34|0.0222
71024761|NCT04081337|141556468|SUPERIORITY||LS Mean difference|-0.36|||<|0.0001|TWO_SIDED|95.0|-0.48|-0.23|||ANCOVA|||||-0.23|-0.48|<0.0001
71024762|NCT01578707|141556482|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||<0.0001
71024763|NCT01578707|141556483|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<.0001
70934577|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|57.0|||||TWO_SIDED|95.0|41.0|72.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||72|41|
70934578|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|57.0|||||TWO_SIDED|95.0|41.0|72.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||72|41|
71024764|NCT01578707|141556484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1653|||||||Log Rank|||||||0.1653
71024765|NCT03175120|141556500|SUPERIORITY||Treatment contrast|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.09|-0.75|||ANCOVA|||The response and change from baseline in response after 26 weeks are analysed using an analysis of covariance (ANCOVA) model with treatment and previous anti-diabetic treatment as fixed factors and corresponding baseline value as covariate.||-0.75|-1.09|<.0001
71024766|NCT00678392|141556561|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.665|||<|0.0001|TWO_SIDED|95.0|0.544|0.812||P-value was obtained from 1-sided log rank test, stratified by eastern cooperative oncology group (ECOG) and prior treatment. One-sided log-rank test at 0.025 level of significance was used to compare PFS between the 2 treatment arms.|Log Rank|||||0.812|0.544|<0.0001
71024767|NCT00678392|141556562|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.969||||0.3744|TWO_SIDED|95.0|0.8|1.174|||Log Rank|P-value was obtained from a 1-sided log-rank test of treatment stratified by ECOG performance status and prior treatment.||||1.174|0.800|0.3744
71024768|NCT00678392|141556563|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.056||||0.0001|TWO_SIDED|95.0|1.408|3.003|||Cochran-Mantel-Haenszel|P-value was obtained from a 1-sided Cochran-Mantel-Haenszel test of treatment stratified by ECOG performance status and prior treatment.||||3.003|1.408|0.0001
71024769|NCT03882047|141556583|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71024770|NCT03882047|141556583|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71024771|NCT03882047|141556583|OTHER|||||||0.03|||||||ANOVA|||||||0.03
71024772|NCT03882047|141556584|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71024773|NCT03882047|141556584|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71024774|NCT03882047|141556584|OTHER|||||||0.31|||||||ANOVA|||||||0.31
71024775|NCT03882047|141556585|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71024776|NCT03882047|141556585|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71024777|NCT03882047|141556585|OTHER|||||||0.01|||||||ANOVA|||||||0.01
71024778|NCT03882047|141556586|OTHER|||||||0.08|||||||ANOVA|||||||0.08
71024779|NCT03882047|141556586|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71024780|NCT03882047|141556586|OTHER|||||||0.1|||||||ANOVA|||||||0.10
71024781|NCT03882047|141556587|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71024782|NCT03882047|141556587|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71024783|NCT03882047|141556587|OTHER|||||||0.01|||||||ANOVA|||||||0.01
71024784|NCT03882047|141556588|OTHER|||||||0.02|||||||ANOVA|||||||0.02
71024785|NCT03882047|141556588|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71024786|NCT03882047|141556588|OTHER|||||||0.05|||||||ANOVA|||||||0.05
71024787|NCT03882047|141556589|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71024788|NCT03882047|141556589|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71024789|NCT03882047|141556589|OTHER|||||||0.06|||||||ANOVA|||||||0.06
71024790|NCT03882047|141556590|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71024791|NCT03882047|141556590|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71024792|NCT03882047|141556590|OTHER|||||||0.46|||||||ANOVA|||||||0.46
71024793|NCT03882047|141556591|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71024794|NCT03882047|141556591|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71024795|NCT03882047|141556591|OTHER|||||||0.07|||||||ANOVA|||||||0.07
71024796|NCT03882047|141556592|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71024797|NCT03882047|141556592|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
70934579|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|0.0|||||TWO_SIDED|95.0|0.0|10.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||10|0|
70934580|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|83.0|||||TWO_SIDED|95.0|67.0|92.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||92|67|
70934581|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|77.0|||||TWO_SIDED|95.0|61.0|88.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||88|61|
70934582|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|71.0|||||TWO_SIDED|95.0|55.0|84.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|55|
70934583|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|66.0|||||TWO_SIDED|95.0|49.0|79.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||79|49|
70934584|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|60.0|||||TWO_SIDED|95.0|44.0|74.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||74|44|
70934585|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|43.0|||||TWO_SIDED|95.0|28.0|59.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||59|28|
70934586|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|31.0|||||TWO_SIDED|95.0|18.0|47.0||||||Children cohort: percent seropositive to DENV-1 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||47|18|
70934587|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|69.0|||||TWO_SIDED|95.0|53.0|82.0||||||Children cohort: percent seropositive to DENV-1 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||82|53|
70934588|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|61.0|||||TWO_SIDED|95.0|45.0|75.0||||||Children cohort: percent seropositive to DENV-1 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||75|45|
70934589|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|56.0|||||TWO_SIDED|95.0|40.0|70.0||||||Children cohort: percent seropositive to DENV-1 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||70|40|
70934590|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|42.0|||||TWO_SIDED|95.0|27.0|58.0||||||Children cohort: percent seropositive to DENV-1 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||58|27|
70934591|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|42.0|||||TWO_SIDED|95.0|27.0|58.0||||||Children cohort: percent seropositive to DENV-1 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||58|27|
71024798|NCT03882047|141556592|OTHER|||||||0.53|||||||ANOVA|||||||0.53
71024799|NCT03882047|141556593|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71024800|NCT03882047|141556593|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71024801|NCT03882047|141556593|OTHER|||||||0.12|||||||ANOVA|||||||0.12
71024802|NCT00770991|141556633|SUPERIORITY_OR_OTHER|||||||0.065|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||All patients received BRB suppositories and were pooled for the analysis comparing baseline and end of study polyp counts.||||0.065
71024803|NCT00770991|141556634|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED|95.0|||||Chi-squared|||||||0.016
71024804|NCT00770991|141556635|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.043
71024805|NCT01945138|141556675|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|||||||0.003
71024806|NCT01945138|141556676|SUPERIORITY_OR_OTHER|||||||0.115|TWO_SIDED||||||t-test, 2 sided|||||||0.115
71024807|NCT01945138|141556677|SUPERIORITY_OR_OTHER|||||||0.193|TWO_SIDED||||||t-test, 2 sided|||||||0.193
71024808|NCT01945138|141556678|SUPERIORITY_OR_OTHER|||||||0.848|TWO_SIDED||||||t-test, 2 sided|||||||0.848
71024809|NCT01945138|141556679|SUPERIORITY_OR_OTHER|||||||0.074|TWO_SIDED||||||t-test, 2 sided|||||||0.074
71024810|NCT01945138|141556680|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED||||||t-test, 2 sided|||||||0.38
71024811|NCT01945138|141556681|SUPERIORITY_OR_OTHER|||||||0.461|TWO_SIDED||||||t-test, 2 sided|||||||0.461
70934592|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|36.0|||||TWO_SIDED|95.0|22.0|54.0||||||Children cohort: percent seropositive to DENV-1 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||54|22|
70934593|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|33.0|||||TWO_SIDED|95.0|20.0|50.0||||||Children cohort: percent seropositive to DENV-2 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||50|20|
70934594|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|92.0|||||TWO_SIDED|95.0|78.0|97.0||||||Children cohort: percent seropositive to DENV-2 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
70934595|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|75.0|96.0||||||Children cohort: percent seropositive to DENV-2 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||96|75|
70934596|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|92.0|||||TWO_SIDED|95.0|78.0|97.0||||||Children cohort: percent seropositive to DENV-2 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
70934597|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|78.0|||||TWO_SIDED|95.0|62.0|88.0||||||children cohort: percent seropositive to DENV-2 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||88|62|
71108074|NCT02941614|141721626|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.15||||0.82|TWO_SIDED|95.0|-1.15|1.45|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||Data below is for the Fact-B 6 month Physical Well-Being Subscale||1.45|-1.15|0.82
71108075|NCT02941614|141721626|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.13||||0.84|TWO_SIDED|95.0|-1.41|1.15|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||Data below is for the Fact-B 12 month Physical Well-Being Subscale||1.15|-1.41|0.84
71108076|NCT02941614|141721626|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.17||||0.77|TWO_SIDED|95.0|-1.31|0.96|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 3 month Social/Family Well-Being Subscale||0.96|-1.31|0.77
71108077|NCT02941614|141721626|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.56||||0.42|TWO_SIDED|95.0|-1.91|0.79|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 6 month Social/Family Well-Being Subscale||0.79|-1.91|0.42
70934598|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|67.0|||||TWO_SIDED|95.0|50.0|80.0||||||Children cohort: percent seropositive to DENV-2 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||80|50|
70934599|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|58.0|||||TWO_SIDED|95.0|42.0|73.0||||||Children cohort: percent seropositive to DENV-2 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||73|42|
70934600|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|36.0|||||TWO_SIDED|95.0|22.0|52.0||||||Children cohort: percent seropositive to DENV-3 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||52|22|
70934601|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|92.0|||||TWO_SIDED|95.0|78.0|97.0||||||Children cohort: percent seropositive to DENV-3 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
70934602|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|92.0|||||TWO_SIDED|95.0|78.0|97.0||||||Children cohort: percent seropositive to DENV-3 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
71024812|NCT01945138|141556682|SUPERIORITY_OR_OTHER|||||||0.205|TWO_SIDED||||||t-test, 2 sided|||||||0.205
70934603|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|86.0|100.0||||||Children cohort: percent seropositive to DENV-3 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|86|
71024813|NCT01945138|141556683|SUPERIORITY_OR_OTHER|||||||0.157|TWO_SIDED||||||t-test, 2 sided|||||||0.157
71024814|NCT01945138|141556684|SUPERIORITY_OR_OTHER|||||||0.443|TWO_SIDED||||||t-test, 2 sided|||||||0.443
71024815|NCT01945138|141556685|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||0.04
71024816|NCT01945138|141556686|SUPERIORITY_OR_OTHER|||||||0.401|TWO_SIDED||||||t-test, 2 sided|||||||0.401
71024817|NCT01945138|141556687|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||t-test, 2 sided|||||||0.22
71108078|NCT02941614|141721626|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.08||||0.9|TWO_SIDED|95.0|-1.41|1.24|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 12 month Social/Family Well-Being Subscale||1.24|-1.41|0.90
71108079|NCT02941614|141721626|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.05||||0.9|TWO_SIDED|95.0|-0.76|0.87|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 3 month Emotional Well-Being Subscale||0.87|-0.76|0.90
71108080|NCT02941614|141721626|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.58||||0.25|TWO_SIDED|95.0|-0.4|1.56|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact B 6 month Emotional Well-Being Subscale||1.56|-0.40|0.25
71108081|NCT02941614|141721626|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.6||||0.22|TWO_SIDED|95.0|-0.36|1.57|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 12 month Emotional Well-Being Subscale||1.57|-0.36|0.22
70934604|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|72.0|||||TWO_SIDED|95.0|56.0|84.0||||||Children cohort: percent seropositive to DENV-3 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|56|
70934605|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|72.0|||||TWO_SIDED|95.0|56.0|84.0||||||Children cohort: percent seropositive to DENV-3 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|56|
70934606|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|67.0|||||TWO_SIDED|95.0|50.0|80.0||||||Children cohort: percent seropositive to DENV-3 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||80|50|
71057295|NCT02933255|141619553|OTHER|||||||0.084||||||The reported p-value is representative of changes in gMDSC at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.084
71057296|NCT02933255|141619553|OTHER|||||||0.151||||||The reported p-value is representative of changes in intermediate monocytes at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.151
71057297|NCT02933255|141619553|OTHER|||||||0.042||||||The reported p-value is representative of changes in intermediate monocytes at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.042
71057298|NCT02933255|141619553|OTHER|||||||0.424||||||The reported p-value is representative of changes in intermediate monocytes at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.424
71057299|NCT02933255|141619553|OTHER|||||||0.846||||||The reported p-value is representative of changes in intermediate monocytes at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.846
71057300|NCT02933255|141619553|OTHER|||||||0.339||||||The reported p-value is representative of changes in non-classical monocytes at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.339
71057301|NCT02933255|141619553|OTHER|||||||0.012||||||The reported p-value is representative of changes in non-classical monocytes at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.012
71057302|NCT02933255|141619553|OTHER|||||||0.622||||||The reported p-value is representative of changes in non-classical monocytes at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.622
71057303|NCT02933255|141619553|OTHER|||||||0.492||||||The reported p-value is representative of changes in non-classical monocytes at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.492
71057304|NCT02933255|141619553|OTHER|||||||0.11||||||The reported p-value is representative of changes in CD4+ CM T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.11
71057305|NCT02933255|141619553|OTHER|||||||0.02||||||The reported p-value is representative of changes in CD4+ CM T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.02
71057306|NCT02933255|141619553|OTHER|||||||0.052||||||The reported p-value is representative of changes in CD4+ CM T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.052
71057307|NCT02933255|141619553|OTHER|||||||0.844||||||The reported p-value is representative of changes in CD4+ CM T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.844
71057308|NCT02933255|141619553|OTHER||||||>|0.999||||||The reported p-value is representative of changes in CD4+ naive T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||>0.999
70934607|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|11.0|||||TWO_SIDED|95.0|4.0|25.0||||||Children cohort: percent seropositive to DENV-4 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||25|4|
70934608|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|72.0|||||TWO_SIDED|95.0|56.0|84.0||||||Children cohort: percent seropositive to DENV-4 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|56|
70934609|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|56.0|||||TWO_SIDED|95.0|40.0|70.0||||||Children cohort: percent seropositive to DENV-4 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||70|40|
70934610|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|44.0|||||TWO_SIDED|95.0|30.0|60.0||||||children cohort: percent seropositive to DENV-4 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||60|30|
70934611|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|28.0|||||TWO_SIDED|95.0|16.0|44.0||||||Children cohort: percent seropositive to DENV-4 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||44|16|
71024818|NCT01945138|141556688|SUPERIORITY_OR_OTHER|||||||0.325|TWO_SIDED||||||t-test, 2 sided|||||||0.325
71024819|NCT01945138|141556689|SUPERIORITY_OR_OTHER|||||||0.311|TWO_SIDED||||||t-test, 2 sided|||||||0.311
71024820|NCT02040766|141556690|SUPERIORITY||Mean Difference (Final Values)|2.81||||0.0063|TWO_SIDED|95.0|0.796|4.821||significance at 0.05.|ANCOVA|||ANCOVA model with effects due to baseline trough morning percent predicted FEV1, sex, age, current protocol-allowed asthma therapy (inhaled corticosteroid (ICS) or non-corticosteroid (NCS) therapy) at the time of screening visit, during the run-in period, and during treatment.||4.821|0.796|0.0063
71024821|NCT02040766|141556690|SUPERIORITY||Mean Difference (Final Values)|0.63||||0.5332|TWO_SIDED|95.0|-1.354|2.614||significance at 0.05.|ANCOVA|||ANCOVA model with effects due to baseline trough morning percent predicted FEV1, sex, age, current protocol-allowed asthma therapy (ICS or NCS therapy) at the time of screening visit, during the run-in period, and during treatment.||2.614|-1.354|0.5332
71024822|NCT02040766|141556690|SUPERIORITY||Mean Difference (Final Values)|0.92||||0.3649|TWO_SIDED|95.0|-1.077|2.924||significance at 0.05|ANCOVA|||ANCOVA model with effects due to baseline trough morning percent predicted FEV1, sex, age, current protocol-allowed asthma therapy (ICS or NCS therapy) at the time of screening visit, during the run-in period, and during treatment.||2.924|-1.077|0.3649
71024823|NCT02040766|141556690|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.2823|TWO_SIDED|95.0|-0.902|3.088|||ANCOVA|||||3.088|-0.902|0.2823
71024824|NCT02040766|141556691|SUPERIORITY||Mean Difference (Final Values)|11.3||||0.0001|TWO_SIDED|95.0|5.58|17.06|||Mixed Models Analysis|||||17.06|5.58|0.0001
71057309|NCT02933255|141619553|OTHER|||||||0.049||||||The reported p-value is representative of changes in CD4+ naive T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.049
70934612|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|25.0|||||TWO_SIDED|95.0|14.0|41.0||||||Children cohort: percent seropositive to DENV-4 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||41|14|
70934613|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|19.0|||||TWO_SIDED|95.0|10.0|35.0||||||children cohort: percent seropositive to DENV-4 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||35|10|
70934614|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|11.0|||||TWO_SIDED|95.0|4.0|25.0||||||Young children cohort: percent seropositive to DENV-1 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||25|4|
70934615|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|78.0|||||TWO_SIDED|95.0|62.0|88.0||||||Young children cohort: percent seropositive to DENV-1 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||88|62|
70934616|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|42.0|||||TWO_SIDED|95.0|27.0|58.0||||||young children cohort: percent seropositive to DENV-1 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||58|27|
70934617|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|53.0|||||TWO_SIDED|95.0|37.0|68.0||||||young children cohort: percent seropositive to DENV-1 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||68|37|
71024825|NCT02040766|141556691|SUPERIORITY||Mean Difference (Final Values)|8.5||||0.0041|TWO_SIDED|95.0|2.71|14.24|||Mixed Models Analysis|||||14.24|2.71|0.0041
71024826|NCT02040766|141556691|SUPERIORITY||Mean Difference (Final Values)|7.6||||0.0103|TWO_SIDED|95.0|1.79|13.35|||Mixed Models Analysis|||||13.35|1.79|0.0103
71024827|NCT02040766|141556691|SUPERIORITY||Mean Difference (Final Values)|6.5||||0.0278|TWO_SIDED|95.0|0.71|12.23|||Mixed Models Analysis|||||12.23|0.71|0.0278
71024828|NCT02040766|141556692|SUPERIORITY||Mean Difference (Final Values)|11.7|||<|0.0001|TWO_SIDED|95.0|5.96|17.45|||Mixed Models Analysis|||||17.45|5.96|<0.0001
71024829|NCT02040766|141556692|SUPERIORITY||Mean Difference (Final Values)|10.0||||0.0007|TWO_SIDED|95.0|4.2|15.76|||Mixed Models Analysis|||||15.76|4.20|0.0007
71024830|NCT02040766|141556692|SUPERIORITY||Mean Difference (Final Values)|9.9||||0.0008|TWO_SIDED|95.0|4.11|15.68|||Mixed Models Analysis|||||15.68|4.11|0.0008
71024831|NCT02040766|141556692|SUPERIORITY||Mean Difference (Final Values)|8.7||||0.0031|TWO_SIDED|95.0|2.95|14.49|||Mixed Models Analysis|||||14.49|2.95|0.0031
71024832|NCT02040766|141556693|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.0002|TWO_SIDED|95.0|-0.548|-0.174|||Mixed Models Analysis|||||-0.174|-0.548|0.0002
71024833|NCT02040766|141556693|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.132|TWO_SIDED|95.0|-0.331|0.044|||Mixed Models Analysis|||||0.044|-0.331|0.1320
71057310|NCT02933255|141619553|OTHER|||||||0.339||||||The reported p-value is representative of changes in CD4+ naive T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.339
71057311|NCT02933255|141619553|OTHER||||||>|0.999||||||The reported p-value is representative of changes in CD4+ naive T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||>0.999
71057312|NCT04803305|141619565|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.01|||TWO_SIDED|90.0|-2.38|1.18|||||Week 4|||1.18|-2.38|
71057313|NCT04803305|141619566|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|90.0|-0.75|3.15|||||Week 1|||3.15|-0.75|
71057314|NCT04803305|141619566|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|90.0|-0.28|2.49|||||Week 2|||2.49|-0.28|
71057315|NCT04803305|141619566|SUPERIORITY||Mean Difference (Final Values)|1.03|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|90.0|-0.93|2.99|||||Week 3|||2.99|-0.93|
71057316|NCT04803305|141619566|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|-2.02|2.02|||||Week 5|||2.02|-2.02|
71057317|NCT04803305|141619566|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|90.0|-3.11|1.51|||||Week 6|||1.51|-3.11|
71057318|NCT04803305|141619567|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|1.98|||TWO_SIDED|90.0|-4.18|3.53|||||Week 1|||3.53|-4.18|
71057319|NCT04803305|141619567|SUPERIORITY||Mean Difference (Final Values)|-2.16|STANDARD_ERROR_OF_MEAN|1.58|||TWO_SIDED|90.0|-5.49|1.16|||||Week 2|||1.16|-5.49|
71057320|NCT04803305|141619567|SUPERIORITY||Mean Difference (Final Values)|0.72|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|90.0|-0.62|2.06|||||Week 3|||2.06|-0.62|
71057321|NCT04803305|141619567|SUPERIORITY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.97|||TWO_SIDED|90.0|-1.29|2.2|||||Week 4|||2.20|-1.29|
71057322|NCT04803305|141619567|SUPERIORITY||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-1.21|2.57|||||Week 5|||2.57|-1.21|
71057323|NCT04803305|141619567|SUPERIORITY||Mean Difference (Final Values)|1.86|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|90.0|0.34|3.39|||||Week 6|||3.39|0.34|
71057324|NCT00708227|141619571|SUPERIORITY|||||||0.27|||||||ANOVA|||||||0.27
71057325|NCT00708227|141619572|SUPERIORITY|||||||0.15|||||||ANOVA|||||||0.15
71024834|NCT02040766|141556693|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.5866|TWO_SIDED|95.0|-0.24|0.136|||Mixed Models Analysis|||||0.136|-0.240|0.5866
71024835|NCT02040766|141556693|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.0587|TWO_SIDED|95.0|-0.369|0.007|||Mixed Models Analysis|||||0.007|-0.369|0.0587
71024836|NCT02040766|141556694|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.0011|TWO_SIDED|95.0|-0.261|-0.065|||Mixed Models Analysis|||||-0.065|-0.261|0.0011
71024837|NCT02040766|141556694|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.0869|TWO_SIDED|95.0|-0.185|0.013|||Mixed Models Analysis|||||0.013|-0.185|0.0869
71024838|NCT02040766|141556694|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.4388|TWO_SIDED|95.0|-0.138|0.06|||Mixed Models Analysis|||||0.060|-0.138|0.4388
71057326|NCT00708227|141619573|SUPERIORITY|||||||0.06|||||||ANOVA|||||||0.06
71057327|NCT02291510|141619598|SUPERIORITY_OR_OTHER||% Ratio of LS Means|35.4|||<|0.001|TWO_SIDED|90.0|32.27|38.74|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of least squares (LS) means and the comparator for the p-values.||38.74|32.27|<0.001
71057328|NCT02291510|141619598|SUPERIORITY_OR_OTHER||% Ratio of LS Means|52.3|||<|0.001|TWO_SIDED|90.0|47.77|57.36|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of LS means and the comparator for the p-values.||57.36|47.77|<0.001
71057329|NCT02291510|141619598|SUPERIORITY_OR_OTHER||% Ratio of LS Means|32.1|||<|0.001|TWO_SIDED|90.0|29.3|35.18|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met IR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||35.18|29.30|<0.001
71057330|NCT02291510|141619598|SUPERIORITY_OR_OTHER||% Ratio of LS Means|47.5|||<|0.001|TWO_SIDED|90.0|43.38|52.09|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met IR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||52.09|43.38|<0.001
71108082|NCT02941614|141721626|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.14||||0.81|TWO_SIDED|95.0|-1.05|1.34|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for Fact-B 3 month Functional Well-Being Subscale||1.34|-1.05|0.81
71108083|NCT02941614|141721626|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.54||||0.45|TWO_SIDED|95.0|-0.85|1.94|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for Fact-B 6 month Functional Well-Being Subscale||1.94|-0.85|0.45
70934618|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|28.0|||||TWO_SIDED|95.0|16.0|44.0||||||Young children cohort: percent seropositive to DENV-1 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||44|16|
70934619|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|28.0|||||TWO_SIDED|95.0|16.0|44.0||||||young children cohort: percent seropositive to DENV-1 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||44|16|
70934620|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|28.0|||||TWO_SIDED|95.0|16.0|44.0||||||Young children cohort: percent seropositive to DENV-1 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||44|16|
70934621|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|11.0|||||TWO_SIDED|95.0|4.0|25.0||||||Young children cohort: percent seropositive to DENV-2 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||25|4|
71024839|NCT02040766|141556694|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.1041|TWO_SIDED|95.0|-0.18|0.017|||Mixed Models Analysis|||||0.017|-0.180|0.1041
71057331|NCT02291510|141619598|SUPERIORITY_OR_OTHER||% Ratio of LS Means|110.1||||0.0832|TWO_SIDED|90.0|100.5|120.68|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of LS means and the comparator for the p-values.||120.68|100.50|0.0832
71024840|NCT02040766|141556695|SUPERIORITY|||||||0.287|||||||Log Rank|||||||0.2870
71024841|NCT02040766|141556695|SUPERIORITY|||||||0.5257|||||||Log Rank|||||||0.5257
71024842|NCT02040766|141556695|SUPERIORITY|||||||0.9982|||||||Log Rank|||||||0.9982
71024843|NCT02040766|141556695|SUPERIORITY|||||||0.7633|||||||Log Rank|||||||0.7633
71024844|NCT00481247|141556708|SUPERIORITY_OR_OTHER|||||||0.0056||||||A priori threshold for statistical significance=0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Hasford Score.||||||0.0056
71024845|NCT00481247|141556709|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.55|1.13||||||||1.13|0.55|
71024846|NCT00481247|141556711|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.46|||||TWO_SIDED|95.0|1.2|1.77||||||Hazard Ratio and Confidence Interval were based on analyses on all randomized subjects||1.77|1.20|
71057332|NCT02291510|141619599|SUPERIORITY_OR_OTHER||% Ratio of LS Means|35.9|||<|0.001|TWO_SIDED|90.0|32.43|39.77|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of LS means and the comparator for the p-values.||39.77|32.43|<0.001
71057333|NCT02291510|141619599|SUPERIORITY_OR_OTHER||% Ratio of LS Means|53.0|||<|0.001|TWO_SIDED|90.0|47.88|58.71|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of LS means and the comparator for the p-values.||58.71|47.88|<0.001
71057334|NCT02291510|141619599|SUPERIORITY_OR_OTHER||% Ratio of LS Means|45.3|||<|0.001|TWO_SIDED|90.0|40.88|50.13|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met IR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||50.13|40.88|<0.001
71057335|NCT02291510|141619599|SUPERIORITY_OR_OTHER||% Ratio of LS Means|66.8|||<|0.001|TWO_SIDED|90.0|60.34|74.0|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met IR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||74.00|60.34|<0.001
71057336|NCT02291510|141619599|SUPERIORITY_OR_OTHER||% Ratio of LS Means|79.3||||0.0004|TWO_SIDED|90.0|71.65|87.86|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of LS means and the comparator for the p-values.||87.86|71.65|0.0004
71057337|NCT03765788|141619600|SUPERIORITY||Odds Ratio (OR)|9.31|||||TWO_SIDED|95.0|3.54|26.29|||||Odd Ratio (posterior median) median and 95% credibility interval calculated using the Bayesian inference|Odds Ratio||26.29|3.54|
71057338|NCT02126826|141619629|SUPERIORITY_OR_OTHER||Slope|0.7865|||||TWO_SIDED|90.0|0.6193|0.9537|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 300mg||0.9537|0.6193|
71057339|NCT02126826|141619629|SUPERIORITY_OR_OTHER||Slope|1.0171|||||TWO_SIDED|90.0|0.8378|1.1964|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 200mg||1.1964|0.8378|
71057340|NCT02126826|141619631|SUPERIORITY_OR_OTHER||Slope|0.9511|||||TWO_SIDED|90.0|0.7654|1.1367|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 300mg||1.1367|0.7654|
71057341|NCT02126826|141619631|SUPERIORITY_OR_OTHER||Slope|1.0834|||||TWO_SIDED|90.0|0.8655|1.3013|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 200mg||1.3013|0.8655|
71057342|NCT02126826|141619633|SUPERIORITY_OR_OTHER||Slope|0.7832|||||TWO_SIDED|90.0|0.6235|0.9428|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 300mg||0.9428|0.6235|
71057343|NCT02126826|141619633|SUPERIORITY_OR_OTHER||Slope|1.0365|||||TWO_SIDED|90.0|0.8593|1.2137|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 200mg||1.2137|0.8593|
71057344|NCT02126826|141619635|SUPERIORITY_OR_OTHER||Slope|0.9433|||||TWO_SIDED|90.0|0.7744|1.1122|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 300mg||1.1122|0.7744|
71057345|NCT02126826|141619635|SUPERIORITY_OR_OTHER||Slope|1.081|||||TWO_SIDED|90.0|0.8583|1.3037|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 200mg||1.3037|0.8583|
71077941|NCT02913105|141664399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.06||||0.3261|TWO_SIDED|90.0|0.96|1.17|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 42||1.17|0.96|0.3261
71024847|NCT00481247|141556712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.54|||||TWO_SIDED|95.0|1.25|1.89||||||Hazard Ratio, and Confidence Interval were based on analyses on all randomized subjects||1.89|1.25|
71024848|NCT01620489|141556722|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.66|||<|0.0001||95.0|-0.9|-0.43||Adjustment for multiple comparisons was not used since there was only one primary endpoint.|Mixed Models Analysis|||The null hypothesis of no treatment difference was tested using a two-sided test based on a mixed model repeated measurement (MMRM) analysis. The model included treatment, country, stratification groups (6 groups from cross-classifying renal function category (2 levels: eGFR\<45 and ≥45 mL/min) and the background insulin treatment category (3 levels: basal, premix or no insulin)) as fixed effects factors and baseline HbA1c as a covariate, all nested within week.||-0.43|-0.90|<0.0001
71024849|NCT01620489|141556723|SUPERIORITY_OR_OTHER||Estimated odds ratio|4.48|||<|0.0001||95.0|2.46|8.18||Not adjusted for multiple comparisons|Regression, Logistic|||Analysed by a logistic regression model with treatment, country and stratification groups as fixed effects and HbA1c and body weight at baseline as covariates. No weight gain was defined as change from baseline to Week 26 in body weight ≤0 kg.||8.18|2.46|<0.0001
71024850|NCT01620489|141556724|SUPERIORITY_OR_OTHER||Estimated odds ratio|3.94|||<|0.0001||95.0|2.12|7.3||Not adjusted for multiple comparisons|Regression, Logistic|||Analysed by a logistic regression model with treatment, country and stratification groups as fixed effects and HbA1c at baseline as covariates.||7.30|2.12|<0.0001
71024851|NCT01620489|141556725|SUPERIORITY_OR_OTHER||Estimated treatment difference|-1.08|||<|0.0001||95.0|-1.58|-0.58||Not adjusted for multiple comparisons|Mixed Models Analysis|||Mean change from baseline in the 7-point profile (SMPG) after 26 weeks treatment was analysed using an MMRM model with treatment, country and stratification groups as fixed effects and baseline as a covariate, all nested within visit.||-0.58|-1.58|<0.0001
71057346|NCT02640482|141619636|NON_INFERIORITY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for Arm A as compared with the historical rate for patients treated with the current standard of care (SOF + RBV for 12 weeks) was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 89% to achieve noninferiority.|Percentage of Participants|99.5|||||TWO_SIDED|95.0|98.5|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of ≥96% in the Arm A (180 participants) provides \>90% power to demonstrate noninferiority of ABT-493/ABT-530 to the historical rate for patients treated with the current standard of care (SOF + RBV for 12 weeks) (95%) (based on the normal approximation of using a single binomial proportion a one-sample test for superiority).||100.0|98.5|
71057347|NCT02640482|141619637|SUPERIORITY|The superiority of the rate of sustained virologic response at 12 weeks after treatment for Arm A as compared with the historical rate for patients treated with the current standard of care (SOF + RBV for 12 weeks) was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 95% to achieve superiority.|Percentage of Participants|99.5|||||TWO_SIDED|95.0|98.5|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of ≥96% in the Arm A (180 participants) provides \>90% power to demonstrate superiority of ABT-493/ABT-530 to the historical rate for patients treated with the current standard of care (SOF + RBV for 12 weeks) (95%) (based on the normal approximation of a single binomial proportion using a one-sample test for superiority).||100.0|98.5|
71057348|NCT00113763|141619661|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Log Rank|Stratified by baseline IVRS ECOG performance status and geographic region||Null hypothesis was no difference between treatment groups||||<0.0001
71057349|NCT00113763|141619662|SUPERIORITY_OR_OTHER_LEGACY|||||||0.806||||||This analysis was conducted contingent on a statistically significant difference in the primary outcome, and adjusted to an a priori threshold for statistical significance at a 4% level for a multiple comparison involving objective tumor response|Log Rank|Stratified by baseline IVRS ECOG performance status and geographic region||Null hypothesis was no difference between treatment groups||||0.806
71057350|NCT02129608|141619683|SUPERIORITY_OR_OTHER|||||||0.398|||||||t-test, 2 sided|||||||0.398
71024852|NCT01620489|141556726|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.51|||=|0.0022||95.0|-0.83|-0.18|||Mixed Models Analysis|Not adjusted for multiple comparisons||Change from baseline in BMI (kg/m˄2) after 26 weeks treatment was analysed separately using an MMRM analysis model with treatment, country and stratification groups as fixed effects and baseline as a covariate, all nested within visit.||-0.18|-0.83|= 0.0022
71057351|NCT02129608|141619683|SUPERIORITY_OR_OTHER|||||||0.436|||||||t-test, 2 sided|||||||0.436
71057352|NCT02129608|141619684|SUPERIORITY_OR_OTHER|||||||0.07|||||||t-test, 2 sided|||||||0.070
71057353|NCT02129608|141619684|SUPERIORITY_OR_OTHER|||||||0.95|||||||t-test, 2 sided|||||||0.950
71057354|NCT00451204|141619691|SUPERIORITY_OR_OTHER||Rate ratio|0.63||||0.077|TWO_SIDED|95.0|0.37|1.05|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 mo, time since dx, previous glatiramer acetate tx, and previous interferon beta tx.||||1.05|0.37|0.077
71057355|NCT00451204|141619692|SUPERIORITY_OR_OTHER||Rate ratio|0.65||||0.098|TWO_SIDED|95.0|0.39|1.08|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 months, time since dx, previous GA treatment, and previous interferon beta treatment.||||1.08|0.39|0.098
71057356|NCT00451204|141619693|SUPERIORITY_OR_OTHER||Rate ratio|0.63||||0.096|TWO_SIDED|95.0|0.36|1.09|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 months, time since dx, previous GA treatment, and previous interferon beta treatment.||||1.09|0.36|0.096
71108084|NCT02941614|141721626|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.11||||0.87|TWO_SIDED|95.0|-1.48|1.26|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 12 month Functional Well-Being Subscale||1.26|-1.48|0.87
71108085|NCT02941614|141721626|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.16||||0.8|TWO_SIDED|95.0|-1.13|1.45|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 3 month Breast Cancer Subscale||1.45|-1.13|0.80
70934622|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|86.0|100.0||||||Young children cohort: percent seropositive to DENV-2 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|86|
70934623|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|86.0|||||TWO_SIDED|95.0|71.0|94.0||||||young children cohort: percent seropositive to DENV-2 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
71057357|NCT00451204|141619694|SUPERIORITY_OR_OTHER||Rate ratio|0.7||||0.179|TWO_SIDED|95.0|0.42|1.17|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 months, time since dx, previous GA treatment, and previous interferon beta treatment.||||1.17|0.42|0.179
71057358|NCT00451204|141619695|SUPERIORITY_OR_OTHER||Rate ratio|0.49||||0.016|TWO_SIDED|95.0|0.28|0.88|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 months, time since dx, previous GA treatment, and previous interferon beta treatment.||||0.88|0.28|0.016
71057359|NCT00451204|141619696|SUPERIORITY_OR_OTHER||Rate ratio|0.52||||0.012|TWO_SIDED|95.0|0.31|0.86|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 months, time since dx, previous GA treatment, and previous interferon beta treatment.||||0.86|0.31|0.012
71057360|NCT02794870|141619714|OTHER||% vaccine recipients with solicited AEs|60.0|||||TWO_SIDED|90.0|39.0|78.0||||||||78|39|
71057361|NCT02794870|141619714|OTHER||% placebo recipients with solicited AEs|27.0|||||TWO_SIDED|90.0|8.0|56.0||||||||56|8|
71057362|NCT02794870|141619715|OTHER||% vaccinees with unsolicited AEs|35.0|||||TWO_SIDED|90.0|18.0|56.0||||||||56|18|
71057363|NCT02794870|141619715|OTHER||% placebo with unsolicited AEs|18.0|||||TWO_SIDED|90.0|3.0|47.0||||||||47|3|
70934624|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|81.0|||||TWO_SIDED|95.0|65.0|90.0||||||Young children cohort: percent seropositive to DENV-2 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|65|
70934625|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|83.0|||||TWO_SIDED|95.0|68.0|92.0||||||young children cohort: percent seropositive to DENV-2 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||92|68|
71057364|NCT02794870|141619720|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Fisher Exact|||||||<0.01
71057365|NCT02794870|141619721|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance is 0.05.|Log Rank|||||||<0.001
71057366|NCT00230178|141619771|SUPERIORITY_OR_OTHER||Difference in response rate %|21.0||||0.0009||95.0|8.6|32.7|||Wilson's method|||||32.7|8.6|0.0009
71057367|NCT00230178|141619771|SUPERIORITY_OR_OTHER||Difference in response rate %|12.3||||0.0632||95.0|-0.9|25.0|||Wilson's method|||||25.0|-0.9|0.0632
71057368|NCT00230178|141619772|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
71057369|NCT00230178|141619772|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
71057370|NCT02652611|141619774|SUPERIORITY||Odds Ratio (OR)|0.3|||=|0.57|TWO_SIDED|95.0|-0.8|1.4|||t-test, 2 sided|||We reported the average pain and function from 6 to 24 months postinjury with 95% confidence intervals (CIs) and summarized pain and function at 6, 9, 12, 18, and 24 months postinjury with means and standard deviations and medians with interquartile ranges.||1.4|-0.8|=0.57
71057371|NCT02652611|141619775|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.21|TWO_SIDED|95.0|-2.9|12.3|||t-test, 2 sided|||||12.3|-2.9|0.21
71057372|NCT02237092|141619778|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71057373|NCT02237092|141619779|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71057374|NCT02237092|141619780|SUPERIORITY_OR_OTHER||||||<|0.02|TWO_SIDED||||||t-test, 2 sided|||||||<0.02
71057375|NCT02237092|141619781|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.58|||<|0.05|TWO_SIDED|95.0|1.05|2.58|||NNT|||||2.58|1.05|<0.05
71057376|NCT03577301|141619782|SUPERIORITY||Wald Chi Square|3.3||||0.35|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted illicit drug use at 3 months.||||||0.35
71057377|NCT03577301|141619782|SUPERIORITY||Wald Chi Square|1.97||||0.58|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted illicit drug use at 6 months.||||||0.58
71057378|NCT03577301|141619782|SUPERIORITY||Wald Chi Square|1.68||||0.64|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted illicit drug use at 9 months.||||||0.64
71057379|NCT03577301|141619782|SUPERIORITY||Wald Chi Square|1.15||||0.76|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted illicit drug use at 12 months.||||||0.76
71057380|NCT03577301|141619783|SUPERIORITY||Wald Chi Square|3.08||||0.38|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted condomless anal sex acts at 3 months.||||||0.38
71057381|NCT03577301|141619783|SUPERIORITY||Wald Chi Square|1.26||||0.74|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted condomless anal sex acts at 6 months.||||||0.74
71057382|NCT03577301|141619783|SUPERIORITY||Wald Chi Square|1.27||||0.74|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted condomless anal sex acts at 9 months.||||||0.74
71057383|NCT03577301|141619783|SUPERIORITY||Slope|3.66||||0.3|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted condomless anal sex acts at 12 months.||||||0.300
71057384|NCT03577301|141619784|SUPERIORITY||Wald Chi Square|1.3||||0.73|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted marijuana use days at 3 months.||||||0.73
71057385|NCT03577301|141619784|SUPERIORITY||Wald Chi Square|1.68||||0.64|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted marijuana use days at 6 months.||||||0.64
71024853|NCT01620489|141556727|SUPERIORITY_OR_OTHER||Estimated treatment ratio|0.98|||=|0.3575||95.0|0.94|1.02||Not adjusted for multiple comparisons|Mixed Models Analysis|||The ratio to baseline in eGFR (mL/min/1.73m˄2) after 26 weeks treatment was estimated based on log-transformed data for changes from baseline. The responses were analysed using an MMRM model with treatment, country and stratification groups as fixed effects and log-transformed baseline as a covariate, all nested within visit. The resulting estimates were back-transformed to the original scale.||1.02|0.94|= 0.3575
71024854|NCT01709383|141556736|SUPERIORITY_OR_OTHER|||||||0.57|||||||Mixed Models Analysis|||||||.57
71024855|NCT01709383|141556738|SUPERIORITY_OR_OTHER|||||||0.64|||||||Mixed Models Analysis|||||||.64
71024856|NCT01360450|141556745|OTHER||Mean Difference (Final Values)|0.05|||>|0.05|TWO_SIDED|||||yes the P value was adjusted for multiple comparisons.|ANOVA|2 sided ANOVA|Mean difference between the two treatment arms|||||>0.05
71024857|NCT01512979|141556752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001||95.0|-1.13|-0.46||The model includes treatment and continuous baseline HbA1c.|ANCOVA|||||-0.46|-1.13|<0.0001
71024858|NCT01512979|141556753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.9|STANDARD_ERROR_OF_MEAN|5.7||0.0032||95.0|-28.0|-5.7||The model includes treatment, continuous baseline HbA1c and continuous baseline FPG.|ANCOVA|||||-5.7|-28.0|0.0032
71024859|NCT01512979|141556755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.83||||0.0031||95.0|1.573|9.328||The model includes treatment and continuous baseline HbA1c.|Regression, Logistic|||||9.328|1.573|0.0031
71057386|NCT03577301|141619784|SUPERIORITY||Wald Chi Square|0.64||||0.89|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted marijuana use days at 9 months.||||||0.89
71057387|NCT03577301|141619784|SUPERIORITY||Wald Chi Square|1.08||||0.78|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted marijuana use days at 12 months.||||||0.78
71057388|NCT03577301|141619785|SUPERIORITY||Wald Chi Square|2.37||||0.5|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted alcohol use days at 3 months.||||||0.50
71057389|NCT03577301|141619785|SUPERIORITY||Wald Chi Square|2.98||||0.34|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted alcohol use days at 6 months.||||||0.34
71057390|NCT03577301|141619785|SUPERIORITY||Wald Chi Square|1.59||||0.66|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted alcohol use days at 9 months.||||||0.66
71057391|NCT03577301|141619785|SUPERIORITY||Wald Chi Square|2.74||||0.43|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted alcohol use days at 12 months.||||||0.43
71057392|NCT00794339|141619791|EQUIVALENCE|equivalence margin=0||||||0.4883|||||||Wilcoxon (Mann-Whitney)|||Participants were divided into two groups by whether their T/M Ratio fell at or above vs. below the observed median of 7.3 and the the median survival was compared between the 2 groups.||||0.4883
71057393|NCT00794339|141619792|EQUIVALENCE|no equivalence margin|Slope|-0.1235|STANDARD_ERROR_OF_MEAN|1.6988||0.1924|TWO_SIDED||||||Regression, Logistic|||Logistic Regression Modeling Complete Metabolic Response by T/M Ratio||||0.1924
71057394|NCT00794339|141619793|EQUIVALENCE|equivalence margin = 0||||||0.309|||||||Wilcoxon (Mann-Whitney)|||Participants were divided into two groups: those at or above the median for T/M Ratio (7.3) vs. those below, and the time to primary tumor recurrence was compared between the 2 goups.||||0.3090
71108086|NCT02941614|141721626|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.73||||0.35|TWO_SIDED|95.0|-0.79|2.24|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 6 month Breast Cancer Subscale||2.24|-0.79|0.35
71108087|NCT02941614|141721626|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.6||||0.42|TWO_SIDED|95.0|-0.88|2.09|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 12 month Breast Cancer Subscale||2.09|-0.88|0.42
71024860|NCT01512979|141556756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.92||||0.0025||95.0|1.458|5.849||The model includes treatment and continuous baseline HbA1c.|Regression, Logistic|||||5.849|1.458|0.0025
71024861|NCT01512979|141556757|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.448||||0.0008||95.0|1.453|4.123||The model includes treatment and continuous baseline HbA1c.|Regression, Logistic|||||4.123|1.453|0.0008
71024862|NCT04192799|141556761|EQUIVALENCE|Testing was two-sided and p-values \<0.05 were considered statistically significant.|Mean Ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.65|0.85||Testing was two-sided and p-values \<0.05 were considered statistically significant, not adjusted for multiple comparison.|Gamma Regression with Log Link Function|Adjusted for demographics, clinical characteristics, time period; interaction term for hospital and time period, random effect for practice group.||||0.85|0.65|<0.001
71057395|NCT00794339|141619794|EQUIVALENCE|equivalence margin=0||||||0.5291|||||||Regression, Logistic|||Logistic Regression Evaluating Tissue to Muscle (T/M) uptake ratio as a Predictor of PELVIC Lymph Node Metastases at Baseline||||0.5291
71057396|NCT00794339|141619794|EQUIVALENCE|equivalence margin=0||||||0.9684|||||||Regression, Logistic|||Logistic Regression Evaluating Tissue to Muscle (T/M) uptake Ratio as a Predictor of COMMON ILIAC Lymph Node Metastases at Baseline||||0.9684
71057397|NCT00794339|141619794|EQUIVALENCE|equivalence margin=0||||||0.7327|||||||Regression, Logistic|||Logistic Regression Evaluating Tissue to Muscle (T/M) uptake Ratio as a Predictor of Para Aortic Lymph Node Metastases at Baseline||||0.7327
71057398|NCT00794339|141619804|EQUIVALENCE|equivalence margin=0||||||0.4981|||||||Wilcoxon (Mann-Whitney)|||Participants were divided into two groups by whether their T/M Ratio fell at or above vs. below the observed median of 7.3 and the time to observe new distant metastases was compared between the groups||||.4981
70851715|NCT00893815|141191352|OTHER||Odds Ratio (OR)|0.74||||0.43|TWO_SIDED|95.0|0.35|1.56||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of abstraction executive functioning impairment between HIV-positive and HIV-negative military beneficiaries||1.56|0.35|0.43
70934626|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|Slope|72.0|||||TWO_SIDED|95.0|56.0|84.0||||||young children cohort: percent seropositive to DENV-2 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|56|
71024863|NCT04192799|141556762|EQUIVALENCE|Testing was two-sided and p-values \<0.05 were considered statistically significant.|Mean Ratio|1.12|||<|0.001|TWO_SIDED|95.0|1.06|1.19||Testing was two-sided and p-values \<0.05 were considered statistically significant, not adjusted for multiple comparison.|Gamma Regression with Log Link Function|Adjusted for demographics, clinical characteristics, time period; interaction term for hospital and time period, random effect for practice group.||||1.19|1.06|<0.001
71024864|NCT04192799|141556763|EQUIVALENCE|Testing was two-sided and p-values \<0.05 were considered statistically significant.|Mean Ratio|0.93||||0.37|TWO_SIDED|95.0|0.8|1.09||Testing was two-sided and p-values \<0.05 were considered statistically significant, not adjusted for multiple comparison.|Gamma Regression with Log Link Function|Adjusted for demographics, clinical characteristics, time period; interaction term for hospital and time period, random effect for practice group.||||1.09|0.80|0.37
71024865|NCT04192799|141556764|EQUIVALENCE|Testing was two-sided and p-values \<0.05 were considered statistically significant.|Odds Ratio (OR)|1.31||||0.81|TWO_SIDED|95.0|0.14|12.27||Testing was two-sided and p-values \<0.05 were considered statistically significant, not adjusted for multiple comparison.|Regression, Logistic|Adjusted for demographics, clinical characteristics, time period; interaction term for hospital and time period, random effect for practice group.||||12.27|0.14|0.81
71024866|NCT04192799|141556765|EQUIVALENCE|Testing was two-sided and p-values \<0.05 were considered statistically significant.|Slope|0.05||||0.12|TWO_SIDED|95.0|-0.01|0.11|||Regression, Linear|Adjusted for demographics, clinical characteristics, time period; interaction term for hospital and time period, random effect for practice group.||||0.11|-0.01|0.12
71057399|NCT00711880|141619835|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.96||||0.004|TWO_SIDED|95.0|-1.59|-0.32|||ANCOVA|||The change in Numerical Rating Scale Peripheral Neuropathic Pain scores was compared between treatment groups using analysis of covariance (ANCOVA). The model included treatment and centre as factors and baseline Numerical Rating Scale Peripheral Neuropathic Pain score as a covariate.||-0.32|-1.59|0.004
71057400|NCT00711880|141619836|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-8.03||||0.007|TWO_SIDED|95.0|-13.83|-2.23|||ANCOVA|||The change in Neuropathic Pain Scale scores was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Neuropathic Pain Scale score as a covariate.||-2.23|-13.83|0.007
71057401|NCT00711880|141619837|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.43||||0.001|TWO_SIDED|95.0|-0.67|-0.19|||ANCOVA|||The change in sleep disturbance scores was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline sleep disturbance score as a covariate.||-0.19|-0.67|0.001
70851716|NCT00893815|141191352|OTHER||Odds Ratio (OR)|1.45||||0.56|TWO_SIDED|95.0|0.41|5.17||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of speed of information processing impairment between HIV-positive and HIV-negative military beneficiaries||5.17|0.41|0.56
70851717|NCT00893815|141191352|OTHER||Odds Ratio (OR)|1.32||||0.49|TWO_SIDED|95.0|0.6|2.93||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of attention/working memory impairment between HIV-positive and HIV-negative military beneficiaries||2.93|0.60|0.49
70851718|NCT00893815|141191352|OTHER||Odds Ratio (OR)|0.43||||0.01|TWO_SIDED|95.0|0.22|0.84||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of learning impairment between HIV-positive and HIV-negative military beneficiaries||0.84|0.22|0.01
71024867|NCT00803959|141556772|NON_INFERIORITY_OR_EQUIVALENCE|The investigators selected the 11% noninferiority margin on the basis of clinical judgement that it was a reasonable threshold for a trade-off between a decrease in the rate of successful treatment and the potential benefits of eliminating UDS studies from preoperative assessment. To minimize bias toward noninferiority, only women treated per protocol (e.g. who underwent the randomly assigned evaluation) were considered in the primary outcome analysis (ITT analysis considered secondary).|Difference in success % (UDS - no UDS)|-0.3|||||TWO_SIDED|95.0|-7.5|6.9|||Chi-squared|Noninferiority declared if the upper boundary of the two-sided 95% confidence interval for the difference in % success (UDS - no UDS) was \< 11%.|Point estimates of success percentage are calculated as 200/259= 77.2% for Office Evaluation Only and 203/264 = 76.9% for Urodynamic Testing arm.|The null hypothesis was that the no UDS group was non-inferior to those in the UDS group. Assuming a significance level of 5% and a true success rate in each group of 70% with a noninferiority margin of 11 percentage points, we needed to enroll 270 women/group to have 80% power for determining whether the results in the no UDS group were non inferior to those in the UDS group. Assuming a 10% dropout rate, a sample of 300 women per group was required.||6.9|-7.5|
71024868|NCT00803959|141556773|SUPERIORITY_OR_OTHER|||||||0.63||95.0||||The p-value is not adjusted for multiple comparisons. Alpha level is considered to be 0.05.|Chi-squared|No adjustments were made; test had 1 degree of freedom.||Null hypothesis is that the two groups will not differ in the percent meeting 70% reduction in Urogenital Distress Inventory score.||||0.63
70851719|NCT00893815|141191352|OTHER||Odds Ratio (OR)|1.39||||0.46|TWO_SIDED|95.0|0.58|3.34||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of recall impairment between HIV-positive and HIV-negative military beneficiaries||3.34|0.58|0.46
70851720|NCT00893815|141191352|OTHER||Odds Ratio (OR)|0.89||||0.76|TWO_SIDED|95.0|0.43|1.85||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of motor speed \& dexterity impairment between HIV-positive and HIV-negative military beneficiaries||1.85|0.43|0.76
70934627|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|69.0|||||TWO_SIDED|95.0|53.0|82.0||||||Young children cohort: percent seropositive to DENV-2 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||82|53|
70934628|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|8.0|||||TWO_SIDED|95.0|3.0|22.0||||||Young children cohort: percent seropositive to DENV-3 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||22|3|
70934629|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|86.0|||||TWO_SIDED|95.0|71.0|94.0||||||Young children cohort: percent seropositive to DENV-3 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
70934630|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|67.0|||||TWO_SIDED|95.0|50.0|80.0||||||young children cohort: percent seropositive to DENV-3 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||80|50|
70934631|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|50.0|||||TWO_SIDED|95.0|34.0|66.0||||||young children cohort: percent seropositive to DENV-3 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||66|34|
71057402|NCT00711880|141619838|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-5.85||||0.003|TWO_SIDED|95.0|-9.62|-2.09|||ANCOVA|||The change in total Pain Disability Index scores was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline total Pain Disability Index score as a covariate.||-2.09|-9.62|0.003
71057403|NCT00711880|141619839|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.82||||0.042|TWO_SIDED|95.0|-1.6|-0.03|||ANCOVA|||The change in Dynamic Allodynia Test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline Dynamic Allodynia Test score as a covariate.||-0.03|-1.60|0.042
71108088|NCT02941614|141721627|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction.|see above|-0.03||||0.59|TWO_SIDED|95.0|-0.15|0.09||We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects|Mixed Models Analysis|||Data below is for the BCPT survey 3 month Total Score.||0.09|-0.15|0.59
71108089|NCT02941614|141721627|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.05||||0.47|TWO_SIDED|95.0|-0.09|0.19|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Total Score||0.19|-0.09|0.47
70934632|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|25.0|||||TWO_SIDED|95.0|14.0|41.0||||||young children cohort: percent seropositive to DENV-3 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||41|14|
70934633|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|31.0|||||TWO_SIDED|95.0|18.0|47.0||||||young children cohort: percent seropositive to DENV-3 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||47|18|
70934634|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|25.0|||||TWO_SIDED|95.0|14.0|41.0||||||young children cohort: percent seropositive to DENV-3 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||41|14|
70934635|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|3.0|||||TWO_SIDED|95.0|0.0|14.0||||||young children cohort: percent seropositive to DENV-4 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||14|0|
70934636|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|75.0|96.0||||||young children cohort: percent seropositive to DENV-4 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||96|75|
70934637|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|72.0|||||TWO_SIDED|95.0|56.0|96.0||||||young children cohort: percent seropositive to DENV-4 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||96|56|
70934638|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|47.0|||||TWO_SIDED|95.0|32.0|63.0||||||young children cohort: percent seropositive to DENV-4 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||63|32|
70934639|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|28.0|||||TWO_SIDED|95.0|16.0|44.0||||||young children cohort: percent seropositive to DENV-4 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||44|16|
70934640|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|28.0|||||TWO_SIDED|95.0|16.0|44.0||||||young children cohort: percent seropositive to DENV-4 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||44|16|
71108090|NCT02941614|141721627|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.06||||0.37|TWO_SIDED|95.0|-0.2|0.07|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Total Score||0.07|-0.20|0.37
71057404|NCT00711880|141619840|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|12.73||||0.144|TWO_SIDED|95.0|-4.4|29.85|||ANCOVA|||The change in Static Allodynia Test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline Static Allodynia Test score as a covariate.||29.85|-4.40|0.144
71057405|NCT00711880|141619841|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.75||||0.483|TWO_SIDED|95.0|-2.84|1.35|||ANCOVA|||The change in total General Health Questionnaire score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline total General Health Questionnaire score as a covariate.||1.35|-2.84|0.483
71057406|NCT00711880|141619842|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.02||||0.924|TWO_SIDED|95.0|-0.46|0.5|||ANCOVA|||The change in selective reminding test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline selective reminding test score as a covariate.||0.50|-0.46|0.924
71057407|NCT00711880|141619843|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.53||||0.214|TWO_SIDED|95.0|-0.31|1.38|||ANCOVA|||The change in 10/36 spatial recall test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline 10/36 spatial recall test score as a covariate.||1.38|-0.31|0.214
71057408|NCT00711880|141619844|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-2.15||||0.158|TWO_SIDED|95.0|-5.15|0.85|||ANCOVA|||The change in symbol digit modalities test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline symbol digit modalities test score as a covariate.||0.85|-5.15|0.158
71057409|NCT00711880|141619845|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|1.28||||0.656|TWO_SIDED|95.0|-4.47|7.04|||ANCOVA|||The change in paced auditory serial addition task score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline paced auditory serial addition task test score as a covariate.||7.04|-4.47|0.656
71057410|NCT00711880|141619846|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.08||||0.962|TWO_SIDED|95.0|-3.56|3.39|||ANCOVA|||The change in word list generation test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline word list generation test score as a covariate.||3.39|-3.56|0.962
71057411|NCT00711880|141619847|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|32.26|||<|0.001|TWO_SIDED|95.0|16.4|48.12|||Fisher Exact|||The proportion of subjects who considered their condition 'Very Much Improved', 'Much Improved' or 'Minimally Improved' was compared between treatment groups for each question, using Fisher's Exact Test.||48.12|16.40|<0.001
71057412|NCT00711880|141619849|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|29.03||||0.001||95.0|13.39|44.67|||Fisher Exact|||The proportion of subjects who considered their condition 'Very Much Improved', 'Much Improved' or 'Minimally Improved' was compared between treatment groups for each question, using Fisher's Exact Test.||44.67|13.39|0.001
71057413|NCT02370238|141619859|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.589|TWO_SIDED|95.0|0.71|1.81||p-value based on a log-rank test stratified by randomized sub-populations, newly diagnosed metastatic patients and patients that had relapsed following a prior (neo)adjuvant chemotherapy regimen.|Log Rank|||||1.81|0.71|0.589
71057414|NCT02370238|141619860|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.897|TWO_SIDED|95.0|0.64|1.65||p-value based on a log-rank test stratified by randomized sub-populations, newly diagnosed metastatic patients and patients that had relapsed following a prior (neo)adjuvant chemotherapy regimen.|Log Rank|||||1.65|0.64|0.897
71057415|NCT02370238|141619861|SUPERIORITY||Odds Ratio (OR)|1.262||||0.667|TWO_SIDED|95.0|0.4909|3.963||P-value is based on Zelen's test for homogeneity of the odds ratios.|Zelen's test|||||3.963|0.4909|0.667
71057416|NCT02370238|141619863|SUPERIORITY|||||||0.767||||||For the All Patients group, p-value was based on a log-rank test stratified by actual sub-populations, newly diagnosed metastatic patients and patients that had relapsed following a prior (neo)adjuvant chemotherapy regimen.|Log Rank|||||||0.767
71057417|NCT02370238|141619864|SUPERIORITY||Odds Ratio (OR)|1.101||||0.667|TWO_SIDED|95.0|0.437|2.79||P-value was based on Zelen's test for homogeneity of the odds ratios|Zelen's test|||||2.790|0.437|0.667
71057418|NCT01569295|141619882|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.0001|TWO_SIDED|95.0|0.27|0.45|||Stratified log-rank test||Hazard Ratio is estimated using Cox proportional hazard model, adjusted for randomization stratification factors.|||0.45|0.27|< 0.0001
71057419|NCT01569295|141619883|SUPERIORITY||Odds Ratio (OR)|3.02|||<|0.0001|TWO_SIDED|95.0|1.98|4.62||Odds ratio,p-value and 95% Confidence Interval(CI) were calculated from Cochran-Mantel-Haenszel(CMH) Chi-square test stratified by stratification factor in EDC(del17p/TP53,immunoglobulin heavy chain variable region(IgHV) mutation and disease status).|Cochran-Mantel-Haenszel|||||4.62|1.98|<0.0001
71057420|NCT01569295|141619884|SUPERIORITY||Odds Ratio (OR)|28.81|||<|0.0001|TWO_SIDED|95.0|10.5|79.02||Odds ratio, p-value and 95% CI were calculated from the CMH Chi-square test stratified by stratification factors in EDC (del17p/TP53, IgHV mutation and disease status).|Cochran-Mantel-Haenszel|||||79.02|10.50|<0.0001
71057421|NCT01569295|141619885|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.098|TWO_SIDED|95.0|0.59|1.03|||Stratified log-rank test|||||1.03|0.59|0.098
71108091|NCT02941614|141721627|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.05||||0.65|TWO_SIDED|95.0|-0.26|0.17|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Hot Flashes Sub-Scale||0.17|-0.26|0.65
70934641|NCT02678455|141369781|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|22.0|||||TWO_SIDED|95.0|12.0|38.0||||||young children cohort: percent seropositive to DENV-4 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||38|12|
70941680|NCT04748445|141383934|OTHER||Slope|-2.911|STANDARD_ERROR_OF_MEAN|1.969||0.1418|TWO_SIDED|90.0|-6.174|3.522|||Mixed Models Analysis|||MM\_Spectral Flatness (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit, estimated value and dispersion value it was 10\^-2. For upper limit it was 10\^-3).||3.522|-6.174|0.1418
71057422|NCT01569295|141619886|SUPERIORITY||Odds Ratio (OR)|9.55||||0.011|TWO_SIDED|95.0|1.19|76.81||Odds ratio, 95% CI and p-value are calculated from the CMH Chi-square test stratified by stratification factors in EDC (del17p/TP53, IgHV mutation and disease status).|Cochran-Mantel-Haenszel|||||76.81|1.19|0.011
71057423|NCT00428116|141619904|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||WAZ-score comparison at 18 months||||0.15
71057424|NCT00428116|141619904|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||HAZ score at 18 months||||0.45
71057425|NCT00428116|141619905|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||log rank or Cox regression|incidence with Cox regression utilized Anderson-Gill method to handle recurrent events||SAEs||||0.39
71057426|NCT00428116|141619905|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Cox regression Anderson Gill|||Pneumonia||||0.60
71057427|NCT00428116|141619905|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Regression, Cox|||Pneumonia||||0.60
71057428|NCT00428116|141619905|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Regression, Cox|||Diarrhea||||0.77
71057429|NCT00428116|141619905|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Log Rank|||Death||||0.29
71057430|NCT01044264|141619934|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|BE of the test to reference in the per protocol population|Wilcoxon Rank Sum Test|100.0|||||TWO_SIDED|90.0|92.47|113.54|||Wilcoxon Rank Sum Test|||||113.54|92.47|
71057431|NCT03901092|141619942|OTHER||Fleiss' kappa|0.87|||||TWO_SIDED|95.0|0.83|0.91||||||Fleiss' kappa is a statistical measure for assessing the reliability of agreement between a fixed number of raters when assigning categorical ratings to a number of items or classifying items. The primary hypothesis to be tested was that the lower bound of two-sided 95% confidence interval of Fleiss' Kappa will be greater than or equal to 0.6.||0.91|0.83|
71057432|NCT03901092|141619945|OTHER||Fleiss' kappa|0.84|||||TWO_SIDED|95.0|0.8|0.88||||||Fleiss' kappa is a statistical measure for assessing the reliability of agreement between a fixed number of raters when assigning categorical ratings to a number of items or classifying items. The primary hypothesis to be tested was that the lower bound of two-sided 95% confidence interval of Fleiss' Kappa will be greater than or equal to 0.6.||0.88|0.80|
71057433|NCT03901092|141619946|OTHER||Fleiss' kappa|0.9|||||TWO_SIDED|95.0|0.85|0.95||||||Fleiss' kappa is a statistical measure for assessing the reliability of agreement between a fixed number of raters when assigning categorical ratings to a number of items or classifying items. The hypothesis to be tested was that the lower bound of two-sided 95% confidence interval of Fleiss' Kappa will be greater than or equal to 0.6.||0.95|0.85|
70941681|NCT04748445|141383934|OTHER||Slope|-0.1487|STANDARD_ERROR_OF_MEAN|8.77||0.0924|TWO_SIDED|90.0|-0.294|-0.003375|||Mixed Models Analysis|||MM\_Third Octave Band (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.003375|-0.2940|0.0924
71057434|NCT03901092|141619947|OTHER||Cohen's kappa|0.89|||||TWO_SIDED|95.0|0.69|1.0||||||Cohen's kappa statistic for Reader 1||1.00|0.69|
71057435|NCT03901092|141619947|OTHER||Cohen's kappa|0.71|||||TWO_SIDED|95.0|0.41|1.0||||||Cohen's kappa statistic for Reader 2||1.00|0.41|
71057436|NCT03901092|141619947|OTHER||Cohen's kappa|0.6|||||TWO_SIDED|95.0|0.24|0.95||||||Cohen's kappa statistic for Reader 3||0.95|0.24|
71057437|NCT03901092|141619947|OTHER||Cohen's kappa|0.89|||||TWO_SIDED|95.0|0.67|1.0||||||Cohen's kappa statistic for Reader 4||1.00|0.67|
71057438|NCT03901092|141619947|OTHER||Cohen's kappa|0.79|||||TWO_SIDED|95.0|0.52|1.0||||||Cohen's kappa statistic for Reader 5||1.00|0.52|
71057439|NCT00086281|141619975|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANOVA on ranks|||||||0.009
71057440|NCT00086281|141619975|SUPERIORITY_OR_OTHER|||||||0.0244||95.0||||Bonferroni adjusted P-Value|ANOVA on ranks|||||||0.0244
71057441|NCT00086281|141619975|SUPERIORITY_OR_OTHER|||||||0.0119||95.0||||Bonferroni adjusted P-Value|ANOVA on ranks|||||||0.0119
71057442|NCT00086281|141619975|SUPERIORITY_OR_OTHER|||||||0.5055||95.0||||Bonferroni adjusted P-Value|ANOVA on ranks|||||||0.5055
71057443|NCT00086281|141619975|SUPERIORITY_OR_OTHER|||||||0.3132||95.0||||Bonferroni adjusted P-Value|ANOVA on ranks|||||||0.3132
71057444|NCT03390426|141619983|SUPERIORITY|"this is a superiority study and the non-inferiority or equivalence analysis is not required"|||||<|0.05||||||Comparisons were made between the two groups using a two-sample t-test or Mann-Whitney U test for continuous variables and Fisher's exact test for categorical variables. p-value of \<0.05 was considered to be statistically significant.|t-test, 2 sided|Comparisons were made using a two-sample t-test or Mann-Whitney U test for continuous variables and Fisher's exact test for categorical variables.||We determined 30 subjects were needed to detect a 50% difference in THN incidence between the two groups using a one-sided Fisher's exact test with alpha = 0.05 and 80% power while allowing up to 20% drop-out. For primary and secondary outcomes, comparisons were made between the two groups using a two-sample t-test or Mann-Whitney U test for continuous variables and Fisher's exact test for categorical variables. p-value of \<0.05 was considered to be statistically significant.||||<0.05
71057445|NCT02924727|141620017|SUPERIORITY||Hazard Ratio (HR)|0.9012||||0.1659|TWO_SIDED|95.0|0.7778|1.0441|||Cox's Proportional Hazard Model|||Primary Composite||1.0441|0.7778|0.1659
71057446|NCT02924727|141620017|SUPERIORITY||Hazard Ratio (HR)|0.874||||0.2031|TWO_SIDED|95.0|0.7104|1.0754|||Cox's Proportional Hazard Model|||CV Death||1.0754|0.7104|0.2031
71057447|NCT02924727|141620017|SUPERIORITY||Hazard Ratio (HR)|0.8653||||0.1679|TWO_SIDED|95.0|0.7044|1.0629|||Cox's Proportional Hazard Model|||First HF Hospitalization||1.0629|0.7044|0.1679
71057448|NCT02924727|141620017|SUPERIORITY||Hazard Ratio (HR)|0.6831||||0.0667|TWO_SIDED|95.0|0.4546|1.0266|||Cox's Proportional Hazard Model|||First Outpatient HF||1.0266|0.4546|0.0667
71057449|NCT02924727|141620018|SUPERIORITY||Hazard Ratio (HR)|0.9133||||0.2507|TWO_SIDED|95.0|0.7824|1.0662|||Cox's Proportional Hazard Model|||CV death or HF hospitalization||1.0662|0.7824|0.2507
70934642|NCT04837937|141369808|SUPERIORITY||Mean Difference (Final Values)|0.1491|STANDARD_ERROR_OF_MEAN|0.51||0.7695||95.0|-0.856|1.15||Alpha for significance=0.05 for all tests.|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the physician treatment arm."||1.15|-.856|.7695
70934643|NCT04837937|141369808|SUPERIORITY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.5077||0.0878||95.0|-1.88|0.13||ALPHA=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister treatment arm."||.13|-1.88|.0878
70934644|NCT04837937|141369808|SUPERIORITY||Mean Difference (Final Values)|0.2414|STANDARD_ERROR_OF_MEAN|0.5077||0.635||95.0|-0.76|1.25||ALPHA=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister/physician treatment arm."||1.25|-.76|.635
70934645|NCT04837937|141369808|SUPERIORITY||Mean Difference (Final Values)|-0.06574|STANDARD_ERROR_OF_MEAN|0.5077||0.897||95.0|-1.0709|0.9394||ALPHA=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the older adult treatment arm."||.9394|-1.0709|.897
70934646|NCT04837937|141369808|SUPERIORITY||Mean Difference (Final Values)|-0.01126|STANDARD_ERROR_OF_MEAN|0.5077||0.9823||95.0|-1.0164|0.9939||ALPHA=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the physician/older adult treatment arm."||.9939|-1.0164|.9823
70934647|NCT04837937|141369808|SUPERIORITY||Mean Difference (Final Values)|-0.4928|STANDARD_ERROR_OF_MEAN|0.5077||0.3337||95.0|-1.4979|0.5124||ALPHA=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister/older adult treatment arm."||.5124|-1.4979|.3337
70934648|NCT04837937|141369808|SUPERIORITY||Mean Difference (Final Values)|0.2002|STANDARD_ERROR_OF_MEAN|0.5077||0.694||95.0|-0.8049|1.2054||ALPHA=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister/older adult/physician treatment arm."||1.2054|-.8049|.694
71024869|NCT00803959|141556774|SUPERIORITY_OR_OTHER|||||||0.68||95.0||||P-value not adjusted for multiple comparisons; a priori threshold for statistical significance set at alpha = 0.05.|Chi-squared|No adjustments made; 1 degree of freedom test.||"Null hypothesis is that there is no difference in the proportion responding very much better or much better on the Patient Global Impression of Improvement at the 12 month visit."||||0.68
71024870|NCT00803959|141556775|SUPERIORITY_OR_OTHER|||||||0.68||95.0||||P-value is not adjusted for multiple comparisons; a priori threshold for statistical significance was set at alpha = 0.05.|t-test, 2 sided|One df t test assumed equal variance; no evidence was found to the contrary.||Null hypothesis is that the two arms do not differ according to change in UDI score.||||0.68
71057450|NCT02924727|141620019|SUPERIORITY||Hazard Ratio (HR)|0.8422||||0.0732|TWO_SIDED|95.0|0.6979|1.0163|||Cox's Proportional Hazard Model|||HF hospitalization or Outpatient HF||1.0163|0.6979|0.0732
70934649|NCT04837937|141369808|SUPERIORITY||Actual Intercept value|54.9056|STANDARD_ERROR_OF_MEAN|0.5077|<|0.0001||95.0|53.9003|55.9109||this is the Intercept value for the GLMM evaluating all combinations of treatment and time- in other words, this is the mean well-being t-score across all combinations of tx and time. Estimates in these analyses are deviations from this intercept.|Mixed Models Analysis|||Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the intercept (all tx=0).||55.9109|53.9003|<.0001
70934650|NCT04837937|141369808|SUPERIORITY||Mean Difference (Final Values)|-0.05579|STANDARD_ERROR_OF_MEAN|0.03516||0.1152||95.0|-0.1254|0.01383||alpha=0.05|Mixed Models Analysis|||Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This test evaluates the effect of time (measured as weeks since baseline).||.01383|-.1254|.1152
70934651|NCT04837937|141369808|SUPERIORITY||Mean Difference (Final Values)|-0.03261|STANDARD_ERROR_OF_MEAN|0.03516||0.3555||95.0|-0.1022|0.03699|||Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the Physician treatment arm\*time."||.03699|-.1022|.3555
71057451|NCT02924727|141620020|SUPERIORITY||Hazard Ratio (HR)|0.9007||||0.1785|TWO_SIDED|95.0|0.7734|1.0489|||Cox's Proportional Hazard Model|||CV death, Non-fatal spontaneous MI or Non-fatal stroke||1.0489|0.7734|0.1785
71057452|NCT02924727|141620021|SUPERIORITY||Rate Ratio|0.8361||||0.0452|TWO_SIDED|95.0|0.7018|0.9961|||Negative Binomial regression model|||Total Number of Confirmed Composite Endpoints||0.9961|0.7018|0.0452
71057453|NCT02924727|141620022|SUPERIORITY||Hazard Ratio (HR)|0.8751||||0.1556|TWO_SIDED|95.0|0.7279|1.052|||Cox's Proportional Hazard Model|||All-Cause Death||1.0520|0.7279|0.1556
71057454|NCT04784533|141620056|SUPERIORITY||Difference in percentages|16.2|||||TWO_SIDED|95.0|5.5|26.8|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 12||26.8|5.5|
70941682|NCT04748445|141383934|OTHER||Slope|3.089|STANDARD_ERROR_OF_MEAN|3.396||0.9277|TWO_SIDED|90.0|-5.318|5.936|||Mixed Models Analysis|||MM\_VLHR (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-2. For estimated value it was 10\^-3).||5.936|-5.318|0.9277
71057455|NCT04784533|141620056|SUPERIORITY||Difference in percentages|12.1|||||TWO_SIDED|95.0|1.3|22.9|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 16||22.9|1.3|
71057456|NCT04784533|141620056|SUPERIORITY||Difference in percentages|26.4|||||TWO_SIDED|95.0|15.4|37.5|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 20||37.5|15.4|
71057457|NCT04784533|141620056|SUPERIORITY||Difference in percentages|19.9|||||TWO_SIDED|95.0|8.5|31.3|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 24||31.3|8.5|
71057458|NCT04784533|141620057|SUPERIORITY||Difference in percentages|0.6|||||TWO_SIDED|95.0|-2.7|3.9|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 8||3.9|-2.7|
71057459|NCT04784533|141620057|SUPERIORITY||Difference in percentages|10.6|||||TWO_SIDED|95.0|3.3|17.9|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 12||17.9|3.3|
71057460|NCT04784533|141620057|SUPERIORITY||Difference in percentages|14.0|||||TWO_SIDED|95.0|5.3|22.8|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 16||22.8|5.3|
71057461|NCT04784533|141620057|SUPERIORITY||Difference in percentages|19.4|||||TWO_SIDED|95.0|9.2|29.5|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 20||29.5|9.2|
71057462|NCT04784533|141620057|SUPERIORITY||Difference in percentages|20.8|||||TWO_SIDED|95.0|9.8|31.7|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 24||31.7|9.8|
71057463|NCT04784533|141620058|SUPERIORITY||Least Square (LS) Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|95.0|-2.8|1.8|||||LS means,standard error(SE),and confidence intervals(CIs) are based on mixed model repeated measures(MMRM)analysis with effects for treatment,visit,treatment-by-visit interaction,and baseline value.The Model uses an unstructured covariance structure.|Week 4||1.8|-2.8|
71057464|NCT04784533|141620058|SUPERIORITY||LS Mean Difference|-7.3|STANDARD_ERROR_OF_MEAN|2.32|||TWO_SIDED|95.0|-11.9|-2.7|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 8||-2.7|-11.9|
71057465|NCT04784533|141620058|SUPERIORITY||LS Mean Difference|-12.4|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-19.3|-5.5|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 12||-5.5|-19.3|
71057466|NCT04784533|141620058|SUPERIORITY||LS Mean Difference|-14.6|STANDARD_ERROR_OF_MEAN|3.9|||TWO_SIDED|95.0|-22.2|-6.9|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 16||-6.9|-22.2|
71057467|NCT04784533|141620058|SUPERIORITY||LS Mean Difference|-15.4|STANDARD_ERROR_OF_MEAN|4.2|||TWO_SIDED|95.0|-23.7|-7.2|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 20||-7.2|-23.7|
71057468|NCT04784533|141620058|SUPERIORITY||LS Mean Difference|-15.4|STANDARD_ERROR_OF_MEAN|4.36|||TWO_SIDED|95.0|-24.0|-6.8|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 24||-6.8|-24.0|
71057469|NCT04784533|141620059|SUPERIORITY||Difference in percentages|20.9|||||TWO_SIDED|95.0|9.9|31.8|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 12||31.8|9.9|
71057470|NCT04784533|141620059|SUPERIORITY||Difference in percentages|13.8|||||TWO_SIDED|95.0|2.5|25.2|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 16||25.2|2.5|
71024871|NCT00803959|141556776|SUPERIORITY_OR_OTHER|||||||0.4||95.0||||P-value was not adjusted for multiple comparisons; a priori threshold for statistical significance set at alpha = 0.05.|t-test, 2 sided|Test was 1 df t-test assuming equal variances; no evidence to the contrary was found.||Null hypothesis is that the 2 arms do not differ according to change in ISI score.||||0.40
71024872|NCT00803959|141556777|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||P-value not adjusted for multiple comparisons; a priori threshold was alpha = 0.05.|t-test, 2 sided|The t test had 1 df assuming equal variances; no evidence of unequal variances was found.||Null hypothesis is that the 2 arms do not differ in change in MESA stress score.||||0.50
71024873|NCT00803959|141556778|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||P-value not adjusted for multiple comparisons and a priori threshold for statistical significance set at alpha = 0.05.|t-test, 2 sided|The t test had 1 df and assumed equal variances; no evidence of different variances was found.||Null hypothesis is that the two arms do not differ according to change in MESA urgency score.||||0.19
71024874|NCT00803959|141556779|SUPERIORITY_OR_OTHER|||||||0.49||95.0||||P-value not adjusted for multiple comparisons and a priori threshold for statistical significance set at alpha = 0.05|t-test, 2 sided|T test had 1 df and assumed equal variance; no evidence of different variances was found.||Null hypothesis is that the 2 arms do not differ according to mean change in IIQ score.||||0.49
71024875|NCT00803959|141556780|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||P-value not adjusted for multiple comparisons and a priori threshold for statistical significance set at alpha = 0.05.|t-test, 2 sided|T test had 1 df assuming equal variances; no evidence of unequal variances was found.||Null hypothesis is that the 2 arms do not differ according to mean change in SF-12 scores.||||0.02
71024876|NCT00803959|141556781|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||t-test, 2 sided|The t test had 1 df and assumed equal variance; no evidence of different variances was found.||Null hypothesis is that the 2 arms do not differ according to mean change in PGI-S score.||||0.51
71024877|NCT00803959|141556782|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Chi-squared|Chi-squared test had 1 df and no adjustments.||Null hypothesis is that the 2 arms do not differ in the proportion of women who score moderate or severe on the PGI-S at 12 months||||0.51
71024878|NCT00803959|141556783|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was alpha = 0.05.|t-test, 2 sided|T test had 1 df and assumed equal variances; no evidence of unequal variances was found.||Null hypothesis is that the 2 arms do not differ according to mean overall patient satisfaction score at 12 months.||||0.28
71024879|NCT00803959|141556784|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||P-values was not adjusted for multiple comparisons and the a priori threshold for statistical significance was set at alpha = 0.05.|Chi-squared|Chi-squared test had 1 df and no adjustments.||Null hypothesis is that the proportion having a positive provocative stress test at 12 months was the same in both treatment arms.||||0.19
71024880|NCT01399723|141556843|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority between amoxicillin and benzyl penicillin was defined a priori as a risk difference of treatment failure and associated upper bound of the 95% confidence interval (CI) of \<7%. A sample size of 576 would provide 80% power to detect noninferiority of amoxicillin against benzyl penicillin within a margin of 7% at a 1-sided level of significance of 0.025, assuming a prevalence of treatment failure of 10% at 48 hours derived from a preintervention pilot phase of the study|Risk Difference (RD)|-0.4|||||TWO_SIDED|95.0|-5.0|4.2|||||Risk difference comparison is for amoxicillin versus benzyl penicillin|||4.2|-5.0|
71024881|NCT01399723|141556844|NON_INFERIORITY_OR_EQUIVALENCE|The initial sample size estimate of 576 children (288 per group) would provide 80% power to detect noninferiority of amoxicillin against benzyl penicillin within a margin of 7% at a 1-sided level of significance of 0.025, assuming a prevalence of treatment failure of 10% at 48 hours derived from a preintervention pilot phase of the study|Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-5.0|5.8|||||Risk difference comparison is for amoxicillin versus benzyl penicillin|||5.8|-5.0|
71024882|NCT01399723|141556847|NON_INFERIORITY_OR_EQUIVALENCE|The initial sample size estimate of 576 children (288 per group) would provide 80% power to detect noninferiority of amoxicillin against benzyl penicillin within a margin of 7% at a 1-sided level of significance of 0.025, assuming a prevalence of treatment failure of 10% at 48 hours derived from a preintervention pilot phase of the study|Risk Difference (RD)|-3.3|||||TWO_SIDED|95.0|-10.0|3.0|||||Risk difference comparison is for amoxicillin versus benzyl penicillin|||3.0|-10.0|
71024883|NCT03051256|141556851|SUPERIORITY||||||<|0.0122|||||||Mixed Models Analysis|||||||<0.0122
71024884|NCT03051256|141556851|SUPERIORITY||||||<|0.0308|||||||Mixed Models Analysis|||||||<0.0308
71024885|NCT03051256|141556852|SUPERIORITY||||||<|0.0103|||||||Mixed Models Analysis|||||||<0.0103
71057471|NCT04784533|141620059|SUPERIORITY||Difference in percentages|15.6|||||TWO_SIDED|95.0|4.1|27.0|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 20||27.0|4.1|
71057472|NCT04784533|141620059|SUPERIORITY||Difference in percentages|14.4|||||TWO_SIDED|95.0|2.9|25.9|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 24||25.9|2.9|
71057473|NCT04784533|141620060|SUPERIORITY||Difference in percentages|22.9|||||TWO_SIDED|95.0|11.9|34.0|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 12||34.0|11.9|
71024886|NCT03051256|141556852|SUPERIORITY||||||<|0.0039|||||||Mixed Models Analysis|||||||<0.0039
71024887|NCT03051256|141556853|SUPERIORITY|||||||0.1237|||||||Mixed Models Analysis|||||||0.1237
71024888|NCT03051256|141556853|SUPERIORITY|||||||0.1017|||||||Mixed Models Analysis|||||||0.1017
71024889|NCT03051256|141556854|SUPERIORITY||||||<|0.0066|||||||Mixed Models Analysis|||||||<0.0066
71024890|NCT03051256|141556854|SUPERIORITY||||||<|0.0014|||||||Mixed Models Analysis|||||||<0.0014
71024891|NCT03051256|141556855|SUPERIORITY||||||<|0.0245|||||||Mixed Models Analysis|||||||<0.0245
71057474|NCT04784533|141620060|SUPERIORITY||Difference in percentages|21.9|||||TWO_SIDED|95.0|10.7|33.1|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 16||33.1|10.7|
71108092|NCT02941614|141721627|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.08||||0.54|TWO_SIDED|95.0|-0.17|0.33|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Hot Flashes Sub-Scale||0.33|-0.17|0.54
71108093|NCT02941614|141721627|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.02||||0.87|TWO_SIDED|95.0|-0.27|0.22|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Hot Flashes Sub-Scale||0.22|-0.27|0.87
71108094|NCT02941614|141721627|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.06||||0.32|TWO_SIDED|95.0|-0.17|0.06|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Nausea Sub-Scale||0.06|-0.17|0.32
71108095|NCT02941614|141721627|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.0||||0.96|TWO_SIDED|95.0|-0.15|0.14|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Nausea Sub-Scale||0.14|-0.15|0.96
71108096|NCT02941614|141721627|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.07||||0.32|TWO_SIDED|95.0|-0.21|0.07|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Nausea Sub-Scale||0.07|-0.21|0.32
71108097|NCT02941614|141721627|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.07||||0.44|TWO_SIDED|95.0|-0.24|0.11|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Bladder Control Sub-Scale||0.11|-0.24|0.44
71108098|NCT02941614|141721627|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.09||||0.38|TWO_SIDED|95.0|-0.11|0.3|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Bladder Control Sub-Scale||0.30|-0.11|0.38
71108099|NCT02941614|141721627|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.07||||0.47|TWO_SIDED|95.0|-0.28|0.13|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is for the BCPT survey 12 month Bladder Control Sub-Scale||0.13|-0.28|0.47
71108100|NCT02941614|141721627|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.17||||0.13|TWO_SIDED|95.0|-0.39|0.05|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Vaginal Problems Sub-Scale||0.05|-0.39|0.13
71108101|NCT02941614|141721627|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.29||||0.03|TWO_SIDED|95.0|-0.55|-0.02|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Vaginal Problems Sub-Scale||-0.02|-0.55|0.03
70941683|NCT04748445|141383934|OTHER||Slope|0.8362|STANDARD_ERROR_OF_MEAN|2.077|<|0.0001|TWO_SIDED|90.0|0.492|1.18|||Mixed Models Analysis|||READ\_MFCC mean 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||1.180|0.4920|<.0001
71024892|NCT03051256|141556855|SUPERIORITY||||||<|0.0253|||||||Mixed Models Analysis|||||||<0.0253
71024893|NCT03051256|141556856|SUPERIORITY||||||<|0.0454|||||||Mixed Models Analysis|||||||<0.0454
71024894|NCT03051256|141556856|SUPERIORITY||||||<|0.0043|||||||Mixed Models Analysis|||||||<0.0043
71024895|NCT03051256|141556857|SUPERIORITY|||||||0.0177|||||||Mixed Models Analysis|||||||0.0177
71024896|NCT03051256|141556857|SUPERIORITY|||||||0.0072|||||||Mixed Models Analysis|||||||0.0072
71024897|NCT03051256|141556858|SUPERIORITY|||||||0.0895|||||||Mixed Models Analysis|||||||0.0895
71024898|NCT03051256|141556858|SUPERIORITY|||||||0.0109|||||||Mixed Models Analysis|||||||0.0109
71024899|NCT00268346|141556864|SUPERIORITY_OR_OTHER||percentage response|6.9|||<|0.05|TWO_SIDED|95.0|||||binomial test for a single proportion|||In patients with prior chemotherapy, \>25% response indicates efficacy and \<10% indicates lack of efficacy. In patients with no prior chemotherapy, \>45% response indicates efficacy and \<25% indicates lack of efficacy. Using a 5% significance level, the study was designed to have 80% power to test each hypothesis.||||<0.05
71024900|NCT00981253|141556869|SUPERIORITY||Mean Difference (Final Values)|-10.1|||||TWO_SIDED|95.0|-18.7|-1.5|||ANCOVA|||||-1.5|-18.7|
71108102|NCT02941614|141721627|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.19||||0.14|TWO_SIDED|95.0|-0.45|0.06|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Vaginal Problems Sub-Scale||0.06|-0.45|0.14
70934652|NCT04837937|141369808|SUPERIORITY||Mean Difference (Final Values)|0.06825|STANDARD_ERROR_OF_MEAN|0.03516||0.0546||95.0|-0.00136|0.1379||alpha=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister treatment arm\*time."||.1379|-.00136|.0546
71057475|NCT04784533|141620060|SUPERIORITY||Difference in percentages|22.6|||||TWO_SIDED|95.0|11.2|33.9|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 20||33.9|11.2|
71057476|NCT04784533|141620060|SUPERIORITY||Difference in percentages|19.5|||||TWO_SIDED|95.0|8.1|31.0|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 24||31.0|8.1|
71057477|NCT04784533|141620061|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.9|-0.3|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 12||-0.3|-0.9|
71057478|NCT04784533|141620061|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-1.1|-0.4|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 16||-0.4|-1.1|
71057479|NCT04784533|141620061|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|-1.2|-0.4|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 20||-0.4|-1.2|
71057480|NCT04784533|141620061|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-1.2|-0.3|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 24||-0.3|-1.2|
71057481|NCT04784533|141620062|SUPERIORITY||Least Square (LS) Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.7|-0.1|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Week 12||-0.1|-0.7|
71057482|NCT04784533|141620062|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-1.0|-0.3|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Week 16||-0.3|-1.0|
71057483|NCT04784533|141620062|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-1.2|-0.5|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Week 20||-0.5|-1.2|
71057484|NCT04784533|141620062|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-1.2|-0.4|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Week 24||-0.4|-1.2|
71057485|NCT04784533|141620063|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.7|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Thickness Hair Coverage: Week 12||-0.2|-0.7|
71057486|NCT04784533|141620063|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.7|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Thickness Hair Coverage: Week 16||-0.2|-0.7|
71057487|NCT04784533|141620063|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.8|-0.3|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Thickness Hair Coverage: Week 20||-0.3|-0.8|
71057488|NCT04784533|141620063|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.8|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Thickness Hair Coverage: Week 24||-0.2|-0.8|
71057489|NCT04784533|141620063|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.8|-0.3|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Evenness Hair Coverage: Week 12||-0.3|-0.8|
71108103|NCT02941614|141721627|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.07||||0.53|TWO_SIDED|95.0|-0.14|0.28|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Musculoskeletal Pain Sub-Scale||0.28|-0.14|0.53
70934653|NCT04837937|141369808|SUPERIORITY||Mean Difference (Final Values)|0.02597|STANDARD_ERROR_OF_MEAN|0.03516||0.4616||95.0|-0.04364|0.09557||alpha=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the Sister/Physician treatment arm\*time."||.09557|-.04364|.4616
70934654|NCT04837937|141369808|SUPERIORITY||Mean Difference (Final Values)|0.0498|STANDARD_ERROR_OF_MEAN|0.03516||0.1592||95.0|-0.0198|0.1194||alpha=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the Older Adult treatment arm\*time."||.1194|-.0198|.1592
70934655|NCT04837937|141369808|SUPERIORITY||Mean Difference (Final Values)|-0.02435|STANDARD_ERROR_OF_MEAN|0.03516||0.4899||95.0|-0.09396|0.04526|||Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the Physician/Older Adult treatment arm\*time."||.04526|-.09396|.4899
70934656|NCT04837937|141369808|SUPERIORITY||Mean Difference (Final Values)|0.000697|STANDARD_ERROR_OF_MEAN|0.03516||0.9842||95.0|-0.06891|0.0703||alpha=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister/older adult treatment arm\*time."||.0703|-.06891|.9842
70934657|NCT04837937|141369808|SUPERIORITY||Mean Difference (Final Values)|-0.01255|STANDARD_ERROR_OF_MEAN|0.03516||0.7217||95.0|-0.08216|0.05705||alpha=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the Sister/Older Adult/Physician treatment arm\*time."||.05705|-.08216|.7217
70934658|NCT04837937|141369809|SUPERIORITY||Mean Difference (Final Values)|-0.74|STANDARD_DEVIATION|6.55||0.21||95.0|-1.9|0.42||Threshold for statistical significance was alpha=0.05.|2-sided paired t-Test|||Univariate ANOVA- analytic variable is change in PROMIS Anxiety score from baseline to T3. Test is a paired T-Test.||.42|-1.90|.21
71057490|NCT04784533|141620063|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.7|-0.3|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Evenness Hair Coverage: Week 16||-0.3|-0.7|
71024901|NCT00981253|141556870|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
71024902|NCT00981253|141556871|SUPERIORITY||Cox Proportional Hazard|0.47|||||TWO_SIDED|95.0|0.24|0.91|||Log Rank|||||0.91|0.24|
71057491|NCT04784533|141620063|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.8|-0.3|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Evenness Hair Coverage: Week 20||-0.3|-0.8|
71057492|NCT04784533|141620063|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.8|-0.3|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Evenness Hair Coverage: Week 24||-0.3|-0.8|
71057493|NCT04784533|141620063|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.8|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyebrows: Week 12||-0.2|-0.8|
71057494|NCT04784533|141620063|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.6|-0.1|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyebrows: Week 16||-0.1|-0.6|
71024903|NCT00981253|141556872|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.95|TWO_SIDED|95.0|-0.14|1.17|||ANCOVA|||||1.17|-0.14|.95
71024904|NCT00981253|141556873|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.99|TWO_SIDED|95.0|-0.22|0.46|||ANCOVA|||||0.46|-0.22|0.99
71024905|NCT00981253|141556874|SUPERIORITY||Mean Difference (Final Values)|0.46||||0.99|TWO_SIDED|95.0|-0.78|1.74|||ANCOVA|||||1.74|-0.78|0.99
71024906|NCT00981253|141556875|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.99|TWO_SIDED|95.0|-0.22|0.46|||ANCOVA|||||0.46|-0.22|0.99
71024907|NCT00981253|141556875|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.99|TWO_SIDED|95.0|-0.14|0.39|||ANCOVA|||||0.39|-0.14|0.99
71024908|NCT00294723|141556876|NON_INFERIORITY_OR_EQUIVALENCE|The two sided 95% confidence interval for the treatment difference \[liraglutide - glimepiride\] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete confidence interval was below 0%.|Estimated treatment difference, LS Mean|-0.62|||<|0.0001||95.0|-0.83|-0.42||"The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity.~2-sided significance level 5%"|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.42|-0.83|<0.0001
71057495|NCT04784533|141620063|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.7|-0.1|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyebrows: Week 20||-0.1|-0.7|
71057496|NCT04784533|141620063|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.7|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyebrows: Week 24||-0.2|-0.7|
71057497|NCT04784533|141620063|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.7|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyelashes: Week 12||-0.2|-0.7|
71057498|NCT04784533|141620063|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.7|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyelashes: Week 16||-0.2|-0.7|
71057499|NCT04784533|141620063|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.7|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyelashes: Week 20||-0.2|-0.7|
71057500|NCT04784533|141620063|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.8|-0.3|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyelashes: Week 24||-0.3|-0.8|
71057501|NCT00307437|141620067|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[less than or equal to 90 kg vs greater than 90 kg)\].||||||<0.001
71057502|NCT00307437|141620067|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control for the multiplicity for the primary endpoint analysis, the Holm's procedure was used at an overall significance level of 0.05.|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[less than or equal 90 kg vs greater than 90 kg)\].||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significance level of 0.05. Sample Size: With 1200 participants (400 in each treatment group), simulation studies were conducted to calculate the power to detect a treatment difference in the primary endpoint between ustekinumab groups and placebo using a CMH test stratified by baseline weight \[\<=90kg vs \> 90 kg). For all the scenarios evaluated, the power is \>99% at an overall significance level of 0.05.||||<0.001
71057503|NCT00307437|141620068|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[less than or equal 90 kg vs greater than 90 kg)\].||||||<0.001
71057504|NCT00307437|141620068|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control the multiplicity for the primary and the secondary endpoint analyses, Holm's procedure was used but the two comparisons for the primary endpoint need to be significant first.|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[less than or equal 90 kg vs greater than 90 kg)\].||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significancd level of 0.05.||||<0.001
71057505|NCT00307437|141620069|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|Analysis of variance on van der Waerden normal scores (Conover, 1980) with treatment and baseline weight (≤ 90kg vs \> 90 kg) as factors in the model||||||<0.001
71057506|NCT00307437|141620069|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control the multiplicity for the primary and the secondary endpoint analyses, Holm's procedure was used but the two comparisons for the primary endpoint and the two comparisons for the 1st second endpoint analyses need to be significant first.|ANOVA on van der Waerden normal scores|Analysis of varianceon van der Waerden normal scores (Conover, 1980) with treatment and baseline weight (≤90 kg vs \>90 kg) as factors in the model||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significance level of 0.05.||||<0.001
71057507|NCT00307437|141620070|SUPERIORITY_OR_OTHER|||||||0.468||95.0|||||Cochran-Mantel-Haenszel (row mean score)|Stratified by baseline weight \[less than or equal to 90 kg vs greater than 90 kg)\].||||||0.468
71057508|NCT00307437|141620070|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Cochran-Mantel-Haenszel (row mean score)|Stratified by baseline weight \[less than or equal to 90 kg vs greater than 90 kg)\].||||||0.210
71057509|NCT00307437|141620070|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||To control the overall multiplicity, the combined groups was tested first and each dose will then be tested; but the primary and the 1st 2 secondary endpoint analyses need to be significant before this endpoint can be tested.|Cochran-Mantel-Haenszel (row mean score)|Stratified by baseline weight \[less than or equal to 90 kg vs greater than 90 kg)\].||Null Hypothesis: No difference between combined q8 group and the combined q12 group, 45 mg q8 and 45 mg q12, 90 mg q8 and 90 mg q12 at an overall significance level of 0.05.||||0.014
71057510|NCT00754546|141620076|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANOVA|||"ANOVA was used to examine the interaction between mode of exercise and treatment effect.~Twenty patients were considered adequate to provide a power of 85% with an alpha of 0.05."||||< 0.05
71057511|NCT00754546|141620076|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||t-test, 2 sided|||Comparing arformoterol with placebo with treadmill exercise||||0.024
71057512|NCT00754546|141620076|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||t-test, 2 sided|||Arformoterol versus normal saline with cycle exercise||||0.038
71057513|NCT00451178|141620108|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.989|||||TWO_SIDED|95.0|0.223|4.393|||||Hazard ratio comparing PFS of participants with a high expression of EIF4EBP1 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of EIF4EBP1 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker EIF4EBP1 Cytoplasm with PFS.||4.393|0.223|
70934659|NCT04837937|141369810|SUPERIORITY||Mean Difference (Final Values)|-3.24|STANDARD_DEVIATION|11.54||0.0021||95.0|-5.28|-1.2||Threshold for significance was 0.05.|2-sided dependent sample t-test|||Univariate ANOVA on change in Zarit Caregiver Burden Score, Baseline to 1-month post-intervention. Test was a 2-sided dependent samples t-test.||-1.20|-5.28|.0021
71057514|NCT00451178|141620108|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.071|||||TWO_SIDED|95.0|0.316|3.628|||||Hazard ratio comparing PFS of participants with a high expression of EIF4E Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of EIF4E Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker EIF4E Cytoplasm with PFS.||3.628|0.316|
71057515|NCT00451178|141620108|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.658|||||TWO_SIDED|95.0|0.454|6.053|||||Hazard ratio comparing PFS of participants with a high expression of HDAC2 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of HDAC2 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker HDAC2 Nucleus with PFS.||6.053|0.454|
71057516|NCT00451178|141620108|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|4.082|||||TWO_SIDED|95.0|0.455|36.628|||||Hazard ratio comparing PFS of participants with a high expression of PCREB Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PCREB Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PCREB Nucleus with PFS.||36.628|0.455|
71057517|NCT00451178|141620108|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.636|||||TWO_SIDED|95.0|0.18|2.253|||||Hazard ratio comparing PFS of participants with a high expression of PEIF3746 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PEIF3746 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PEIF3746 Cytoplasm with PFS.||2.253|0.180|
71108104|NCT02941614|141721627|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.1||||0.47|TWO_SIDED|95.0|-0.16|0.35|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Musculoskeletal Pain Sub-Scale||0.35|-0.16|0.47
71108105|NCT02941614|141721627|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.07||||0.57|TWO_SIDED|95.0|-0.18|0.33|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Musculoskeletal Pain Sub-Scale||0.33|-0.18|0.57
71108106|NCT02941614|141721627|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.02||||0.85|TWO_SIDED|95.0|-0.18|0.21|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Cognitive Problems Sub-Scale||0.21|-0.18|0.85
71057518|NCT00451178|141620108|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.362|||||TWO_SIDED|95.0|0.083|1.576|||||Hazard ratio comparing PFS of participants with a high expression of PEIF3746 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PEIF3746 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PEIF3746 Nucleus with PFS.||1.576|0.083|
71108107|NCT02941614|141721627|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.1||||0.38|TWO_SIDED|95.0|-0.12|0.32|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Cognitive Problems Sub-Scale||0.32|-0.12|0.38
71108108|NCT02941614|141721627|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.13||||0.23|TWO_SIDED|95.0|-0.35|0.09|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Cognitive Problems Sub-Scale||0.09|-0.35|0.23
71108109|NCT02941614|141721627|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.14||||0.18|TWO_SIDED|95.0|-0.35|0.07|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Weight Problems Sub-Scale||0.07|-0.35|0.18
71024909|NCT00294723|141556876|NON_INFERIORITY_OR_EQUIVALENCE|The two sided 95% confidence interval for the treatment difference \[liraglutide - glimepiride\] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete confidence interval was below 0%. Superiority of 1.2 mg liraglutide was only tested if 1.2 mg liraglutide was non-inferior to glimepiride and 1.8 mg liraglutide was superior to glimepiride.|Estimated treatment difference, LS Mean|-0.33||||0.0014||95.0|-0.53|-0.13||"The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity.~2-sided significance level 5%"|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.13|-0.53|0.0014
71057519|NCT00451178|141620108|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.522|||||TWO_SIDED|95.0|0.473|4.901|||||Hazard ratio comparing PFS of participants with a high expression of PEIFS209 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PEIFS209 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PEIFS209 Cytoplasm with PFS.||4.901|0.473|
71057520|NCT00451178|141620108|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.908|||||TWO_SIDED|95.0|0.223|3.699|||||Hazard ratio comparing PFS of participants with a high expression of PEIFS65 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PEIFS65 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PEIFS65 Nucleus with PFS.||3.699|0.223|
71057521|NCT00451178|141620108|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.843|||||TWO_SIDED|95.0|0.432|7.867|||||Hazard ratio comparing PFS of participants with a high expression of PEIFT70 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PEIFT70 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PEIFT70 Nucleus with PFS.||7.867|0.432|
71057522|NCT00451178|141620108|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.926|||||TWO_SIDED|95.0|0.276|3.109|||||Hazard ratio comparing PFS of participants with a high expression of P GSK3B Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of P GSK3B Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker P GSK3B Cytoplasm with PFS.||3.109|0.276|
71057523|NCT00451178|141620108|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.985|||||TWO_SIDED|95.0|0.32|3.033|||||Hazard ratio comparing PFS of participants with a high expression of PKCb2 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PKCb2 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PKCb2 Cytoplasm with PFS.||3.033|0.320|
71057524|NCT00451178|141620108|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.817|||||TWO_SIDED|95.0|0.242|2.758|||||Hazard ratio comparing PFS of participants with a high expression of PTEN Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PTEN Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PTEN Cytoplasm with PFS.||2.758|0.242|
71057525|NCT01277601|141620182|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Raw p-values comparing treatments were based on a log-rank test stratified by HBeAg status and viral genotype.|Log Rank|||||||< 0.001
71057526|NCT01277601|141620182|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Raw p-values comparing treatments were based on a log-rank test stratified by HBeAg status and viral genotype.|Log Rank|||||||0.002
71057527|NCT01009814|141620238|OTHER||Mean Difference (Net)|-0.1089|STANDARD_ERROR_OF_MEAN|0.212||0.6102|TWO_SIDED|90.0|-0.4656|0.2477|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.2477|-0.4656|0.6102
71057528|NCT01009814|141620238|OTHER||Mean Difference (Net)|-0.1266|STANDARD_ERROR_OF_MEAN|0.2076||0.5452|TWO_SIDED|90.0|-0.4758|0.2225|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.2225|-0.4758|0.5452
71057529|NCT01009814|141620238|OTHER||Mean Difference (Net)|-0.1682|STANDARD_ERROR_OF_MEAN|0.2055||0.4178|TWO_SIDED|90.0|-0.5139|0.1775|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.1775|-0.5139|0.4178
71057530|NCT01009814|141620238|OTHER||Mean Difference (Net)|-0.4885|STANDARD_ERROR_OF_MEAN|0.2075||0.0233|TWO_SIDED|90.0|-0.8375|-0.1395|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||-0.1395|-0.8375|0.0233
71057531|NCT01009814|141620238|OTHER||Mean Difference (Net)|-0.0177|STANDARD_ERROR_OF_MEAN|0.2043||0.9314|TWO_SIDED|90.0|-0.3613|0.3259|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.3259|-0.3613|0.9314
71057532|NCT01009814|141620238|OTHER||Mean Difference (Net)|-0.0592|STANDARD_ERROR_OF_MEAN|0.2045||0.7734|TWO_SIDED|90.0|-0.4032|0.2847|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.2847|-0.4032|0.7734
71057533|NCT01009814|141620238|OTHER||Mean Difference (Net)|-0.3796|STANDARD_ERROR_OF_MEAN|0.2043||0.0702|TWO_SIDED|90.0|-0.7232|-0.036|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||-0.0360|-0.7232|0.0702
71057534|NCT01009814|141620238|OTHER||Mean Difference (Net)|-0.0415|STANDARD_ERROR_OF_MEAN|0.1993||0.8359|TWO_SIDED|90.0|-0.3768|0.2937|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.2937|-0.3768|0.8359
71057535|NCT01009814|141620238|OTHER||Mean Difference (Net)|-0.3619|STANDARD_ERROR_OF_MEAN|0.1988||0.0759|TWO_SIDED|90.0|-0.6962|-0.0275|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||-0.0275|-0.6962|0.0759
71057536|NCT01009814|141620238|OTHER||Mean Difference (Net)|-0.3203|STANDARD_ERROR_OF_MEAN|0.1993||0.1155|TWO_SIDED|90.0|-0.6555|0.0149|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.0149|-0.6555|0.1155
71057537|NCT03022084|141620278|NON_INFERIORITY|The probability that Desyncra is non-inferior to CBT, defined by the sponsor as the event that mean TQ score change from baseline in the Desyncra arm is no more than 3.5 points worse than the mean TQ change in the CBT arm.|||||||||||||Bayesian|Data collected to date were analyzed using a Bayesian approach.|||Data collected to date were analyzed using a Bayesian approach.|||
71024910|NCT00294723|141556876|NON_INFERIORITY_OR_EQUIVALENCE|A test for superiority of liraglutide 1.8 mg to liraglutide 1.2 mg was performed to compare the two doses. Superiority of liraglutide 1.8 mg was concluded if the upper limit of the 2-sided 95% CI for the treatment difference (liraglutide 1.8 mg - liraglutide 1.2 mg) was below 0%.|Estimated treatment difference, LS Mean|-0.29||||0.0046||95.0|-0.5|-0.09||2-sided significance level 5%|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.09|-0.50|0.0046
71024911|NCT00294723|141556877|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.58|||<|0.0001||95.0|-4.28|-2.87||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.87|-4.28|<.0001
71024912|NCT00294723|141556877|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.17|||<|0.0001||95.0|-3.87|-2.47||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.47|-3.87|<.0001
71057538|NCT04933383|141620279|SUPERIORITY||difference/ratio of least square means|180.6||||0.000813|TWO_SIDED|95.0|106.42|306.48|||ANCOVA|||"The primary efficacy endpoint is the change from baseline in PC20 after each treatment period (baseline is defined at Visit 1).~For primary efficacy analysis, the mean PC20 changes from baseline between AQ001S and the comparator were compared by analysis of covariance (ANCOVA) for crossover design. A p-value was calculated for the difference of the parameter between AQ001S and the comparator.~Additionally, an adjusted 95%-CI for the mean difference was obtained by the ANCOVA."||306.48|106.42|0.000813
71057539|NCT00180661|141620293|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
71057540|NCT00180661|141620294|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||||||0.005
71057541|NCT02661217|141620388|SUPERIORITY||Risk Ratio (RR)|0.896||||0.099|TWO_SIDED|95.0|0.786|1.021|||Cochran-Mantel-Haenszel|||||1.021|0.786|0.099
71057542|NCT02661217|141620389|SUPERIORITY||Risk Ratio (RR)|0.906||||0.034|TWO_SIDED|95.0|0.827|0.993|||Cochran-Mantel-Haenszel|||||0.993|0.827|0.034
71057543|NCT02661217|141620390|SUPERIORITY||Risk Ratio (RR)|0.96||||0.089|TWO_SIDED|95.0|0.916|1.006|||Cochran-Mantel-Haenszel|||||1.006|0.916|0.089
71057544|NCT02075515|141620393|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Superiority Criterion: The two-sided 95 % CI of the GMC ratio between all pairs of lots are within \[0.67, 1.5\]|Adjusted GMC Ratio|0.97|||||TWO_SIDED|95.0|0.86|1.09|||ANCOVA|||||1.09|0.86|
71057545|NCT02075515|141620393|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Superiority Criterion: The two-sided 95 % CI of the GMC ratio between all pairs of lots are within \[0.67, 1.5\]|Adjustd GMC Ratio|0.96|||||TWO_SIDED|95.0|0.85|1.08|||ANCOVA|||||1.08|0.85|
71057546|NCT02075515|141620393|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Superiority Criterion: The two-sided 95 % CI of the GMC ratio between all pairs of lots are within \[0.67, 1.5\].|Adjusted GMC ratio|0.99|||||TWO_SIDED|95.0|0.88|1.1|||ANCOVA|||||1.10|0.88|
71057547|NCT04238650|141620419|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.04|||||TWO_SIDED|90.0|0.981|1.11||||||||1.11|0.981|
71057548|NCT04238650|141620420|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25. The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.13|||||TWO_SIDED|90.0|1.03|1.24||||||||1.24|1.03|
71057549|NCT04238650|141620421|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUClast was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.05|||||TWO_SIDED|90.0|0.997|1.11||||||||1.11|0.997|
71057550|NCT01807065|141620428|OTHER|||||||0.06|||||||Log Rank|||||||0.06
71057551|NCT01406444|141620485|SUPERIORITY|||||||0.03|||||||Linear random effects model|||||||0.03
71057552|NCT01406444|141620486|SUPERIORITY|||||||0.002|||||||Linear random effects model|||||||0.002
71057553|NCT01406444|141620486|SUPERIORITY|||||||0.04|||||||Linear random effects model|||||||0.04
71057554|NCT01685840|141620487|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.88|TWO_SIDED|95.0|0.79|1.22||A sample size of 1100 patients was expected to provide approximately 90% power to detect a difference in the primary endpoint with an assumed type I error rate of 0.05, 2-sided. Analysis was adjusted for age, sex, ejection fraction, NT-proBNP and DM.|Regression, Cox|||||1.22|0.79|0.88
71057555|NCT01685840|141620488|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86||||0.37|TWO_SIDED|95.0|0.62|1.2|||Regression, Cox|||||1.20|0.62|0.37
71057556|NCT01685840|141620489|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.0||||0.53|TWO_SIDED|95.0|-20.0|39.0|||Bang-Tsiatis Partitioned Estimator|||||39|-20|0.53
71057557|NCT01685840|141620490|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.75|TWO_SIDED|95.0|0.65|1.37|||Regression, Cox|||||1.37|0.65|0.75
71057558|NCT01685840|141620491|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.76|TWO_SIDED|95.0|0.82|1.31|||Regression, Cox|||||1.31|0.82|0.76
71057559|NCT01685840|141620492|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.08|TWO_SIDED|95.0|0.97|1.72|||Anderson-Gill Intensity Model|||||1.72|0.97|0.08
71057560|NCT01685840|141620493|SUPERIORITY|||||||0.636|||||||Mixed Models Analysis|||Baseline||||0.636
71057561|NCT01685840|141620493|SUPERIORITY|||||||0.628|||||||Mixed Models Analysis|||3 month||||0.628
71057562|NCT01685840|141620493|SUPERIORITY|||||||0.586|||||||Mixed Models Analysis|||6 month||||0.586
70934660|NCT04837937|141369811|SUPERIORITY||Mean Difference (Final Values)|-1.19|STANDARD_DEVIATION|8.1||0.1||95.0|-2.62|0.25||Alpha for statistical significance was 0.05|2-Sided Paired T Test|||Univariate ANOVA- analytic variable is change in PROMIS Fatigue score from baseline to T3. Test is a paired T-Test.||.25|-2.62|.10
70934661|NCT04837937|141369812|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|7.83||0.9754||95.0|-1.36|1.41|||2-sided paired (dependent sample) t-test|||Univariate ANOVA on change in PROMIS short form General Self Efficacy T-Score, baseline to one month post-intervention. Test is a 2-sided paired (dependent sample) t-test.||1.41|-1.36|.9754
71057563|NCT01685840|141620493|SUPERIORITY|||||||0.669|||||||Mixed Models Analysis|||12 month||||0.669
71057564|NCT01685840|141620493|SUPERIORITY|||||||0.949|||||||Mixed Models Analysis|||24 month||||0.949
71057565|NCT01685840|141620494|SUPERIORITY||Mean Difference (Final Values)|0.88||||0.404|TWO_SIDED|95.0|-1.188|2.947||Adjusted P-value|Mixed Models Analysis|||3 month||2.947|-1.188|0.404
71057566|NCT01685840|141620494|SUPERIORITY||Mean Difference (Final Values)|1.478||||0.219|TWO_SIDED|95.0|-0.881|3.836||Adjusted P-value|Mixed Models Analysis|||6 month||3.836|-0.881|0.219
71057567|NCT01685840|141620494|SUPERIORITY||Mean Difference (Final Values)|2.099||||0.104|TWO_SIDED|95.0|-0.433|4.63||Adjusted P-value|Mixed Models Analysis|||12 month||4.630|-0.433|0.104
71057568|NCT01685840|141620494|SUPERIORITY||Mean Difference (Final Values)|1.999||||0.228|TWO_SIDED|95.0|-1.253|5.25|||Mixed Models Analysis|||24 month||5.250|-1.253|0.228
71057569|NCT01685840|141620495|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.421|TWO_SIDED|95.0|-0.025|0.06||Adjusted P-value|Mixed Models Analysis|||3 month||0.060|-0.025|0.421
71057570|NCT01685840|141620495|SUPERIORITY||Mean Difference (Final Values)|0.028||||0.239|TWO_SIDED|95.0|-0.018|0.074||Adjusted P-value|Mixed Models Analysis|||6 month||0.074|-0.018|0.239
71057571|NCT01685840|141620495|SUPERIORITY||Mean Difference (Final Values)|0.021||||0.402|TWO_SIDED|95.0|-0.028|0.07|||Mixed Models Analysis|||12 month||0.070|-0.028|0.402
70934662|NCT04837937|141369814|SUPERIORITY||Mean Difference (Final Values)|0.1296|STANDARD_DEVIATION|4.91||0.77||95.0|-0.74|1.0||Threshold for significance is 0.05|2-sided Paired T-Test|||Univariate ANOVA on change in T-Score between baseline and 1 month post-intervention. Test is a 2-sided paired t-test.||1.00|-.74|.77
70934663|NCT04837937|141369815|SUPERIORITY||Mean Difference (Final Values)|0.7618|STANDARD_DEVIATION|6.16||0.1694||95.0|-0.33|1.85||alpha threshold for significance was 0.05.|two-sided paired T-Test|||Univariate ANOVA on change in T-score between baseline and one month post-intervention. Test is a two-sided paired t-test.||1.85|-.33|.1694
71057572|NCT01685840|141620495|SUPERIORITY||Mean Difference (Final Values)|0.009||||0.78|TWO_SIDED|95.0|-0.057|0.076||Adjusted P-value|Mixed Models Analysis|||24 month||0.076|-0.057|0.780
71057573|NCT01685840|141620496|SUPERIORITY||Mean Difference (Final Values)|-2.131||||0.268|TWO_SIDED|95.0|-5.902|1.64||Adjusted P-value|Mixed Models Analysis|||3 month||1.640|-5.902|0.268
71057574|NCT01685840|141620496|SUPERIORITY||Mean Difference (Final Values)|1.069||||0.599|TWO_SIDED|95.0|-2.921|5.058|||Mixed Models Analysis|||6 month||5.058|-2.921|0.599
71057575|NCT01685840|141620496|SUPERIORITY||Mean Difference (Final Values)|-0.389||||0.852|TWO_SIDED|95.0|-4.486|3.707||Adjusted P-value|Mixed Models Analysis|||12 month||3.707|-4.486|0.852
71057576|NCT01685840|141620496|SUPERIORITY||Mean Difference (Final Values)|-3.343||||0.221|TWO_SIDED|95.0|-8.708|2.022||Adjusted P-value|Mixed Models Analysis|||24 month||2.022|-8.708|0.221
71057577|NCT01685840|141620497|SUPERIORITY||Mean Difference (Final Values)|-0.816||||0.615|TWO_SIDED|95.0|-3.999|2.367||Adjusted P-value|Mixed Models Analysis|||3 month||2.367|-3.999|0.615
71057578|NCT01685840|141620497|SUPERIORITY||Mean Difference (Final Values)|0.252||||0.878|TWO_SIDED|95.0|-2.977|3.482||Adjusted P-value|Mixed Models Analysis|||6 month||3.482|-2.977|0.878
71057579|NCT01685840|141620497|SUPERIORITY||Mean Difference (Final Values)|-1.406||||0.441|TWO_SIDED|95.0|-4.989|2.178||Adjusted P-value|Mixed Models Analysis|||12 month||2.178|-4.989|0.441
71057580|NCT01685840|141620497|SUPERIORITY||Mean Difference (Final Values)|1.091||||0.653|TWO_SIDED|95.0|-3.673|5.856||Adjusted P-value|Mixed Models Analysis|||24 month||5.856|-3.673|0.653
71057581|NCT01685840|141620498|SUPERIORITY||Mean Difference (Final Values)|-1.226||||0.199|TWO_SIDED|95.0|-3.097|0.645||Adjusted P-value|Mixed Models Analysis|||3 month||0.645|-3.097|0.199
71057582|NCT01685840|141620498|SUPERIORITY||Mean Difference (Final Values)|-0.742||||0.465|TWO_SIDED|95.0|-2.735|1.25|||Mixed Models Analysis|||6 month||1.250|-2.735|0.465
71057583|NCT01685840|141620498|SUPERIORITY||Mean Difference (Final Values)|-0.074||||0.943|TWO_SIDED|95.0|-2.119|1.97||Adjusted P-value|Mixed Models Analysis|||12 month||1.970|-2.119|0.943
71057584|NCT01685840|141620498|SUPERIORITY||Mean Difference (Final Values)|1.478||||0.294|TWO_SIDED|95.0|-1.286|4.241||Adjusted P-value|Mixed Models Analysis|||24 month||4.241|-1.286|0.294
71057585|NCT01685840|141620499|SUPERIORITY||Mean Difference (Final Values)|-1.579||||0.294|TWO_SIDED|95.0|-4.527|1.369||Adjusted P-value|Mixed Models Analysis|||3 month||1.369|-4.527|0.294
71057586|NCT01685840|141620499|SUPERIORITY||Mean Difference (Final Values)|-0.946||||0.555|TWO_SIDED|95.0|-4.096|2.203||Adjusted P-value|Mixed Models Analysis|||6 month||2.203|-4.096|0.555
71057587|NCT01685840|141620499|SUPERIORITY||Mean Difference (Final Values)|-0.798||||0.643|TWO_SIDED|95.0|-4.178|2.583||Adjusted P-value|Mixed Models Analysis|||12 month||2.583|-4.178|0.643
71057588|NCT01685840|141620499|SUPERIORITY||Mean Difference (Final Values)|-0.647||||0.757|TWO_SIDED|95.0|-4.767|3.472||Adjusted P-value|Mixed Models Analysis|||24 month||3.472|-4.767|0.757
71057589|NCT01685840|141620500|SUPERIORITY||Mean Difference (Final Values)|-0.484||||0.837|TWO_SIDED|95.0|-5.102|4.133||Adjusted P-value|Mixed Models Analysis|||3 month||4.133|-5.102|0.837
70934664|NCT04837937|141369820|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_DEVIATION|16.44||0.76||||||Alpha for Significance=0.05|ANOVA|||Univariate ANOVA on change in Avoiding Score (out of 100) between Baseline and 1 Month Post-Intervention.||||.76
70851721|NCT06457204|141191380|OTHER||Ratio of adjusted geometric means [%]|101.6|||||TWO_SIDED|90.0|98.4|105.0|||||"Ratio of adjusted geometric means \[%\] calculated as: test/reference\*100.~Intra-individual geometric coefficient of variation (gCV) \[%\] = 6.9."|Analysis of variance (ANOVA) on the logarithmic scale included effects for sequence, subjects nested within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. confidence intervals (CIs) were calculated based on the residual error from the ANOVA and quantiles from the t-distribution. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs.||105.0|98.4|
71057590|NCT01685840|141620500|SUPERIORITY||Mean Difference (Final Values)|-2.693||||0.288|TWO_SIDED|95.0|-7.662|2.276||Adjusted P-value|Mixed Models Analysis|||6 month||2.276|-7.662|0.288
71057591|NCT01685840|141620500|SUPERIORITY||Mean Difference (Final Values)|-1.539||||0.567|TWO_SIDED|95.0|-6.81|3.732||Adjusted P-value|Mixed Models Analysis|||12 month||3.732|-6.810|0.567
71057592|NCT01685840|141620500|SUPERIORITY||Mean Difference (Final Values)|2.512||||0.475|TWO_SIDED|95.0|-4.394|9.419||Adjusted P-value|Mixed Models Analysis|||24 month||9.419|-4.394|0.475
71057593|NCT01685840|141620501|SUPERIORITY||Mean Difference (Final Values)|1.057||||0.696|TWO_SIDED|95.0|-4.25|6.364||Adjusted P-value|Mixed Models Analysis|||3 month||6.364|-4.250|0.696
71057594|NCT01685840|141620501|SUPERIORITY||Mean Difference (Final Values)|1.966||||0.497|TWO_SIDED|95.0|-3.715|7.647||Adjusted P-value|Mixed Models Analysis|||6 months||7.647|-3.715|0.497
71057595|NCT01685840|141620501|SUPERIORITY||Mean Difference (Final Values)|6.564||||0.035|TWO_SIDED|95.0|0.456|12.673||Adjusted P-value|Mixed Models Analysis|||12 month||12.673|0.456|0.035
71057596|NCT01685840|141620501|SUPERIORITY||Mean Difference (Final Values)|2.857||||0.488|TWO_SIDED|95.0|-5.247|10.961||Adjusted P-value|Mixed Models Analysis|||24 month||10.961|-5.247|0.488
71057597|NCT01685840|141620502|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.992|TWO_SIDED|95.0|-3.383|3.417||Adjusted P-value|Mixed Models Analysis|||3 month||3.417|-3.383|0.992
71057598|NCT01685840|141620502|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.882|TWO_SIDED|95.0|-3.409|3.969||Adjusted P-value|Mixed Models Analysis|||6 month||3.969|-3.409|0.882
71057599|NCT01685840|141620502|SUPERIORITY||Mean Difference (Final Values)|0.904||||0.647|TWO_SIDED|95.0|-2.973|4.782||Adjusted P-value|Mixed Models Analysis|||12 month||4.782|-2.973|0.647
71057600|NCT01685840|141620502|SUPERIORITY||Mean Difference (Final Values)|0.322||||0.903|TWO_SIDED|95.0|-4.894|5.538||Adjusted P-value|Mixed Models Analysis|||24 month||5.538|-4.894|0.903
71057601|NCT01685840|141620503|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Hospitalizations||||0.74
71057602|NCT01685840|141620503|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||ER only events||||0.45
71057603|NCT01685840|141620503|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Rehab facilities||||0.67
71057604|NCT01685840|141620503|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Total admissions||||0.47
71057605|NCT01685840|141620504|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Hospital Costs||||0.88
71057606|NCT01685840|141620504|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||Physician Fees||||0.69
71057607|NCT01685840|141620504|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Total Cost||||0.88
71057608|NCT01252277|141620533|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustment for multiple comparisons. A priori threshold for statistical significance, p\<0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
71057609|NCT01252277|141620534|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED|||||No adjustment for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||0.021
71057610|NCT01252277|141620535|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustment for multiple comparisons. A priori threshold for statistical significance p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
71057611|NCT01252277|141620536|SUPERIORITY_OR_OTHER|||||||0.48||||||No adjustment for multiple comparisons. A priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.48
71057612|NCT02006732|141620539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.299|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.261|0.336|||Mixed Effects Model for Repeated Measure|||||0.336|0.261|<0.0001
71057613|NCT02006732|141620539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.069|0.141|||Mixed Effects Model for Repeated Measure|||||0.141|0.069|<0.0001
71057614|NCT02006732|141620539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.284|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.246|0.323|||Mixed Effects Model for Repeated Measure|||||0.323|0.246|<0.0001
71057615|NCT02006732|141620539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.053|0.128|||Mixed Effects Model for Repeated Measure|||||0.128|0.053|<0.0001
71057616|NCT02006732|141620539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.194|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.156|0.232|||Mixed Effects Model for Repeated Measure|||||0.232|0.156|<0.0001
71057617|NCT02006732|141620539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.019||0.4499|TWO_SIDED|95.0|-0.023|0.051|||Mixed Effects Model for Repeated Measure|||||0.051|-0.023|0.4499
71057618|NCT02006732|141620540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.129|0.203|||Mixed Effects Model for Repeated Measure|||||0.203|0.129|<0.0001
71057619|NCT02006732|141620540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|STANDARD_ERROR_OF_MEAN|0.019||0.0395|TWO_SIDED|95.0|0.002|0.076|||Mixed Effects Model for Repeated Measure|||||0.076|0.002|0.0395
71057620|NCT02006732|141620540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.132|0.207|||Mixed Effects Model for Repeated Measure|||||0.207|0.132|<0.0001
71057621|NCT02006732|141620540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.019||0.0269|TWO_SIDED|95.0|0.005|0.079|||Mixed Effects Model for Repeated Measure|||||0.079|0.005|0.0269
71057622|NCT02006732|141620540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.09|0.165|||Mixed Effects Model for Repeated Measure|||||0.165|0.090|<0.0001
71057623|NCT02006732|141620540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.019||0.8669|TWO_SIDED|95.0|-0.04|0.034|||Mixed Effects Model for Repeated Measure|||||0.034|-0.040|0.8669
71057624|NCT02006732|141620541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.564|STANDARD_ERROR_OF_MEAN|0.986|<|0.0001|TWO_SIDED|95.0|-6.499|-2.629|||Mixed Effects Model for Repeated Measure|||||-2.629|-6.499|<0.0001
71024913|NCT00294723|141556877|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-0.41||||0.2584||95.0|-1.11|0.3||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||0.30|-1.11|0.2584
71024914|NCT00294723|141556878|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.65|||<|0.0001||95.0|-4.44|-2.86||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.86|-4.44|<.0001
71024915|NCT00294723|141556878|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-2.84|||<|0.0001||95.0|-3.63|-2.06||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.06|-3.63|<.0001
71024916|NCT00294723|141556878|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-0.8||||0.0462||95.0|-1.59|-0.01||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-0.01|-1.59|0.0462
71024917|NCT00294723|141556879|NON_INFERIORITY_OR_EQUIVALENCE|The two sided 95% confidence interval for the treatment difference \[liraglutide - glimepiride\] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete confidence interval was below 0%.|Estimated treatment difference, LS Mean|-0.6|||<|0.0001||95.0|-0.83|-0.38||"The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity.~2-sided significance level 5%"|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.38|-0.83|<.0001
71024918|NCT00294723|141556879|NON_INFERIORITY_OR_EQUIVALENCE|The two sided 95% CI for the treatment difference \[liraglutide - glimepiride\] was estimated. Liraglutide was non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete confidence interval was below 0%. Superiority of 1.2 mg liraglutide was only tested if 1.2 mg liraglutide was non-inferior to glimepiride and 1.8 mg liraglutide was superior to glimepiride.|Estimated treatment difference, LS Mean|-0.31||||0.0076||95.0|-0.54|-0.08||"The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity.~2-sided significance level 5%"|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.08|-0.54|0.0076
71024919|NCT00294723|141556879|NON_INFERIORITY_OR_EQUIVALENCE|A test for superiority of liraglutide 1.8 mg to liraglutide 1.2 mg was performed to compare the two doses. Superiority of liraglutide 1.8 mg was concluded if the upper limit of the 2-sided 95% CI for the treatment difference (liraglutide 1.8 mg - liraglutide 1.2 mg) was below 0%.|Estimated treatment difference, LS Mean|-0.29||||0.0129||95.0|-0.52|-0.06||2-sided significance level 5%|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.06|-0.52|0.0129
71057625|NCT02006732|141620541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.717|STANDARD_ERROR_OF_MEAN|0.974||0.078|TWO_SIDED|95.0|-3.628|0.193|||Mixed Effects Model for Repeated Measure|||||0.193|-3.628|0.0780
70934665|NCT04837937|141369820|SUPERIORITY||Mean Difference (Final Values)|2.25|STANDARD_DEVIATION|16.33||0.13||||||Alpha for significance=0.05|ANOVA|||Univariate ANOVA on change in Compromising Score (out of 100) between Baseline and 1 Month Post-Intervention.||||.13
70934666|NCT04837937|141369820|SUPERIORITY||Mean Difference (Final Values)|-6.85|STANDARD_DEVIATION|18.76|<|0.0001||||||Alpha for significance=0.05|ANOVA|||Univariate ANOVA on change in Forcing Score (out of 100) between Baseline and 1 Month Post-Intervention.||||<.0001
70934667|NCT04837937|141369820|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_DEVIATION|15.62||0.86||||||Alpha for Significance=0.05|ANOVA|||Univariate ANOVA on change in Problem Solving Score (out of 100) between Baseline and 1 Month Post-Intervention.||||.86
71057626|NCT02006732|141620541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.666|STANDARD_ERROR_OF_MEAN|0.991||0.0002|TWO_SIDED|95.0|-5.611|-1.721|||Mixed Effects Model for Repeated Measure|||||-1.721|-5.611|0.0002
71057627|NCT02006732|141620541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.979||0.4028|TWO_SIDED|95.0|-2.741|1.102|||Mixed Effects Model for Repeated Measure|||||1.102|-2.741|0.4028
71057628|NCT02006732|141620541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.846|STANDARD_ERROR_OF_MEAN|0.993||0.0042|TWO_SIDED|95.0|-4.796|-0.897|||Mixed Effects Model for Repeated Measure|||||-0.897|-4.796|0.0042
71057629|NCT02006732|141620541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.898|STANDARD_ERROR_OF_MEAN|0.971||0.3555|TWO_SIDED|95.0|-2.804|1.008|||Mixed Effects Model for Repeated Measure|||||1.008|-2.804|0.3555
71057630|NCT02006732|141620542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.668|STANDARD_ERROR_OF_MEAN|0.71|<|0.0001|TWO_SIDED|95.0|-6.06|-3.276|||Mixed Effects Model for Repeated Measure|||||-3.276|-6.060|<0.0001
71057631|NCT02006732|141620542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.097|STANDARD_ERROR_OF_MEAN|0.701||0.0028|TWO_SIDED|95.0|-3.471|-0.723|||Mixed Effects Model for Repeated Measure|||||-0.723|-3.471|0.0028
71057632|NCT02006732|141620542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.846|STANDARD_ERROR_OF_MEAN|0.711|<|0.0001|TWO_SIDED|95.0|-5.24|-2.451|||Mixed Effects Model for Repeated Measure|||||-2.451|-5.240|<0.0001
71057633|NCT02006732|141620542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.274|STANDARD_ERROR_OF_MEAN|0.702||0.0696|TWO_SIDED|95.0|-2.651|0.102|||Mixed Effects Model for Repeated Measure|||||0.102|-2.651|0.0696
71057634|NCT02006732|141620542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.571|STANDARD_ERROR_OF_MEAN|0.714||0.0003|TWO_SIDED|95.0|-3.971|-1.171|||Mixed Effects Model for Repeated Measure|||||-1.171|-3.971|0.0003
71057635|NCT02006732|141620542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.822|STANDARD_ERROR_OF_MEAN|0.698||0.2387|TWO_SIDED|95.0|-2.191|0.546|||Mixed Effects Model for Repeated Measure|||||0.546|-2.191|0.2387
71057636|NCT02006732|141620543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.252|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.187|0.317|||Mixed Effects Model for Repeated Measure|||||0.317|0.187|<0.0001
71057637|NCT02006732|141620543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.033||0.0614|TWO_SIDED|95.0|-0.003|0.125|||Mixed Effects Model for Repeated Measure|||||0.125|-0.003|0.0614
71057638|NCT02006732|141620543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.305|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.24|0.37|||Mixed Effects Model for Repeated Measure|||||0.370|0.240|<0.0001
71057639|NCT02006732|141620543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.033||0.0005|TWO_SIDED|95.0|0.049|0.178|||Mixed Effects Model for Repeated Measure|||||0.178|0.049|0.0005
71057640|NCT02006732|141620543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.191|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.126|0.256|||Mixed Effects Model for Repeated Measure|||||0.256|0.126|<0.0001
71057641|NCT02006732|141620543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.033||0.1089|TWO_SIDED|95.0|-0.117|0.012|||Mixed Effects Model for Repeated Measure|||||0.012|-0.117|0.1089
71057642|NCT02006732|141620544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.195|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|0.665|1.725|||Mixed Effects Model for Repeated Measure|||||1.725|0.665|<0.0001
71057643|NCT02006732|141620544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.582|STANDARD_ERROR_OF_MEAN|0.267||0.0296|TWO_SIDED|95.0|0.058|1.106|||Mixed Effects Model for Repeated Measure|||||1.106|0.058|0.0296
71057644|NCT02006732|141620544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.263|STANDARD_ERROR_OF_MEAN|0.272|<|0.0001|TWO_SIDED|95.0|0.73|1.796|||Mixed Effects Model for Repeated Measure|||||1.796|0.730|<0.0001
71057645|NCT02006732|141620544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.269||0.0159|TWO_SIDED|95.0|0.122|1.178|||Mixed Effects Model for Repeated Measure|||||1.178|0.122|0.0159
71057646|NCT02006732|141620544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.613|STANDARD_ERROR_OF_MEAN|0.273||0.0248|TWO_SIDED|95.0|0.078|1.148|||Mixed Effects Model for Repeated Measure|||||1.148|0.078|0.0248
71057647|NCT02006732|141620544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.068|STANDARD_ERROR_OF_MEAN|0.266||0.7984|TWO_SIDED|95.0|-0.59|0.454|||Mixed Effects Model for Repeated Measure|||||0.454|-0.590|0.7984
71057648|NCT02006732|141620545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.623|STANDARD_ERROR_OF_MEAN|0.193|<|0.0001|TWO_SIDED|95.0|1.245|2.0|||Mixed Effects Model for Repeated Measure|||||2.000|1.245|<0.0001
71057649|NCT02006732|141620545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.594|STANDARD_ERROR_OF_MEAN|0.19||0.0019|TWO_SIDED|95.0|0.22|0.967|||Mixed Effects Model for Repeated Measure|||||0.967|0.220|0.0019
71057650|NCT02006732|141620545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.611|STANDARD_ERROR_OF_MEAN|0.193|<|0.0001|TWO_SIDED|95.0|1.232|1.989|||Mixed Effects Model for Repeated Measure|||||1.989|1.232|<0.0001
71057651|NCT02006732|141620545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.582|STANDARD_ERROR_OF_MEAN|0.191||0.0023|TWO_SIDED|95.0|0.207|0.956|||Mixed Effects Model for Repeated Measure|||||0.956|0.207|0.0023
71057652|NCT02006732|141620545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.029|STANDARD_ERROR_OF_MEAN|0.194|<|0.0001|TWO_SIDED|95.0|0.649|1.41|||Mixed Effects Model for Repeated Measure|||||1.410|0.649|<0.0001
71057653|NCT02006732|141620545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.189||0.9494|TWO_SIDED|95.0|-0.359|0.383|||Mixed Effects Model for Repeated Measure|||||0.383|-0.359|0.9494
71057654|NCT02006732|141620546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.432|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.366|0.498|||Mixed Effects Model for Repeated Measure|||||0.498|0.366|<0.0001
71057655|NCT02006732|141620546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.084|0.212|||Mixed Effects Model for Repeated Measure|||||0.212|0.084|<0.0001
70934668|NCT04837937|141369820|SUPERIORITY||Mean Difference (Final Values)|-1.1|STANDARD_DEVIATION|12.3||0.32||||||Alpha for significance=0.05|ANOVA|||Univariate ANOVA on change in Yielding Score (out of 100) between Baseline and 1 Month Post-Intervention.||||.32
70934669|NCT04837937|141369821|SUPERIORITY||Mean Difference (Final Values)|3.09|STANDARD_DEVIATION|13.18||0.0012||95.0|||||ANOVA|||Univariate ANOVA on change in total Negotiation Knowledge score, Baseline 1-month. Threshold for significance was alpha=0.05.||||.0012
70934670|NCT04837937|141369821|SUPERIORITY||Mean Difference (Final Values)|4.933|STANDARD_DEVIATION|17.33||0.0018||||||alpha=0.05|ANOVA|||Univariate ANOVA on change in Negotiation Knowledge Interests score, Baseline 1-month. Threshold for significance was alpha=0.05.||||.0018
70934671|NCT04837937|141369821|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|19.69||0.91||||||Threshold for significance was alpha=0.05.|ANOVA|||Univariate ANOVA on change in Negotiation Knowledge Power score, Baseline 1-month.||||.91
70934672|NCT04837937|141369821|SUPERIORITY||Mean Difference (Final Values)|3.2|STANDARD_DEVIATION|22.35||0.11||||||Threshold for significance was alpha=0.05.|ANOVA|||Univariate ANOVA on change in Negotiation Knowledge Rights score, Baseline 1-month.||||.11
70934673|NCT04837937|141369823|SUPERIORITY||Mean Difference (Final Values)|-2.08|STANDARD_DEVIATION|5.73|<|0.0001||95.0|-3.09|-1.07||Threshold for significance is alpha=0.05.|2-sided dependent sample t-test|||Univariate ANOVA on change in negative affect score, baseline-1 month post-intervention. Test is a 2 sided dependent sample t-test.||-1.07|-3.09|<.0001
71057656|NCT02006732|141620546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.455|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.387|0.522|||Mixed Effects Model for Repeated Measure|||||0.522|0.387|<0.0001
71057657|NCT02006732|141620546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.105|0.236|||Mixed Effects Model for Repeated Measure|||||0.236|0.105|<0.0001
70934674|NCT04837937|141369823|SUPERIORITY||Mean Difference (Final Values)|0.344|STANDARD_DEVIATION|4.86||0.4305||95.0|-0.52|1.21|||2-sided dependent sample t-test|||Univariate ANOVA of change in positive affect score between baseline-1 month post-intervention. Test is a 2-sided dependent sample t-test.||1.21|-.52|.4305
70934675|NCT01767688|141369832|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio (GMR)|0.94|||||TWO_SIDED|95.0|0.79|1.11|||Geometric least-squares mean ratio (GMR)|||||1.11|0.79|
70934676|NCT01767688|141369833|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio (GMR)|0.94|||||TWO_SIDED|95.0|0.81|1.1|||Geometric least-squares mean ratio (GMR)|||||1.10|0.81|
70934677|NCT01767688|141369834|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio (GMR)|0.81|||||TWO_SIDED|95.0|0.51|1.28|||Geometric least-squares mean ratio (GMR)|||||1.28|0.51|
70934678|NCT01767688|141369835|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio (GMR)|1.03|||||TWO_SIDED|95.0|0.93|1.15|||Geometric least-squares mean ratio (GMR)|||||1.15|0.93|
70934679|NCT02148705|141369843|SUPERIORITY||Odds Ratio (OR)|288.281|||<|0.0001|TWO_SIDED|95.0|35.549|13984.356|||Fisher Exact|||||13984.356|35.549|<0.0001
70934680|NCT02148705|141369844|SUPERIORITY||Odds Ratio (OR)|0.011|||<|0.0001|TWO_SIDED|95.0|0.003|0.044|||Chi-squared|||||0.044|0.003|<0.0001
70934681|NCT02148705|141369845|SUPERIORITY||Test Statistics|23.1429|||<|0.0001|TWO_SIDED||||||Generalized Wilcoxon-Gehan Test|Analysis is adjusted for Overall TW Depths, TBSA Group, Center Group, and Number of TWs||||||<0.0001
70934682|NCT02148705|141369846|SUPERIORITY||estimate|6505.8|STANDARD_ERROR_OF_MEAN|269.88|<|0.0001|TWO_SIDED|95.0|5974.41|7037.19|||Wilcoxon (Mann-Whitney)|Wilcoxon tests pooled using Rubin´s rule||||7037.19|5974.41|<0.0001
70934683|NCT01583166|141369848|OTHER|||||||0.837|||||||Fisher Exact|||||||0.837
70934684|NCT00887224|141369854|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Significance declared if p-value ≤0.05. The estimated probability obtained via Kaplan-Meier estimate.|Log Rank|||||||<0.001
70934685|NCT00887224|141369856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9627|TWO_SIDED|95.0|-0.09|0.08||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 1||0.08|-0.09|0.9627
70934686|NCT00887224|141369856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.1046|TWO_SIDED|95.0|-0.02|0.21||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 2||0.21|-0.02|0.1046
70934687|NCT00887224|141369856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.0228|TWO_SIDED|95.0|0.02|0.25||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 3||0.25|0.02|0.0228
70934688|NCT00887224|141369856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.0064|TWO_SIDED|95.0|0.05|0.29||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 4||0.29|0.05|0.0064
71057658|NCT02006732|141620546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.284|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.217|0.35|||Mixed Effects Model for Repeated Measure|||||0.350|0.217|<0.0001
71057659|NCT02006732|141620546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.022|STANDARD_ERROR_OF_MEAN|0.033||0.4974|TWO_SIDED|95.0|-0.087|0.042|||Mixed Effects Model for Repeated Measure|||||0.042|-0.087|0.4974
71057660|NCT03516513|141620547|SUPERIORITY|t-tests||||||0.905|||||||t-test, 2 sided|||||||0.905
71057661|NCT03516513|141620547|SUPERIORITY|t-test||||||0.32|||||||t-test, 2 sided|||||||.320
71057662|NCT03516513|141620548|SUPERIORITY|||||||0.155||||||Not adjusted for multiple comparisons|t-test, 2 sided|||||||.155
71057663|NCT03516513|141620548|SUPERIORITY|||||||0.974||||||Not adjusted for multiple comparisons|t-test, 2 sided|||||||.974
71057664|NCT03516513|141620550|SUPERIORITY|||||||0.212|||||||t-test, 2 sided|||||||.212
70851722|NCT06457204|141191381|OTHER||Ratio of adjusted geometric means [%]|98.3|||||TWO_SIDED|90.0|91.6|105.5|||||"Ratio of adjusted geometric means \[%\] calculated as: test/reference\*100.~Intra-individual geometric coefficient of variation (gCV) \[%\] = 15.0."|Analysis of variance (ANOVA) on the logarithmic scale included effects for sequence, subjects nested within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. confidence intervals (CIs) were calculated based on the residual error from the ANOVA and quantiles from the t-distribution. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs.||105.5|91.6|
70851723|NCT06457204|141191382|OTHER||Ratio of adjusted geometric means [%]|101.6|||||TWO_SIDED|90.0|98.2|105.0|||||"Ratio of adjusted geometric means \[%\] calculated as: test/reference\*100.~Intra-individual geometric coefficient of variation (gCV) \[%\] = 7.1."|Analysis of variance (ANOVA) on the logarithmic scale included effects for sequence, subjects nested within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. confidence intervals (CIs) were calculated based on the residual error from the ANOVA and quantiles from the t-distribution. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs.||105.0|98.2|
70934689|NCT00887224|141369856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||<|0.001|TWO_SIDED|95.0|0.11|0.39||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 6||0.39|0.11|<0.001
70934690|NCT00887224|141369856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|||<|0.001|TWO_SIDED|95.0|0.12|0.43||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 10||0.43|0.12|<0.001
70934691|NCT00887224|141369856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||<|0.001|TWO_SIDED|95.0|0.19|0.47||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14||0.47|0.19|<0.001
71057665|NCT03516513|141620551|SUPERIORITY|||||||0.507|||||||t-test, 2 sided|||||||.507
71057666|NCT03516513|141620552|SUPERIORITY|||||||0.091|||||||t-test, 2 sided|||||||.091
71057667|NCT00345631|141620562|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.68|||<|0.0001|TWO_SIDED|95.0|-19.04|-12.31||Multiplicity is addressed for the two co-primary effectiveness endpoints via a closed testing procedure where the time to hemostasis will be assessed first and then time to ambulation only if significance is first achieved for time to hemostasis.|t-test, 2 sided|||"Null hypothesis: The mean time to hemostasis for the manual compression (MC) arm is less or equal to that for the vascular closure device (VCD) arm.~The trial is powered to detect a 5 minute reduction in mean time to hemostasis and a 2 hour reduction in mean time to ambulation for VCD vs. MC with over 90% power and a 5% two-sided (2.5% one-sided) Type I error"||-12.31|-19.04|<0.0001
71024920|NCT00294723|141556880|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.48|||<|0.0001||95.0|-4.28|-2.68||2-sided significance level was 5%.|ANCOVA|||Change in body weight from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.68|-4.28|<0.0001
71024921|NCT00294723|141556880|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-2.72|||<|0.0001||95.0|-3.52|-1.93||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-1.93|-3.52|<0.0001
71057668|NCT00345631|141620563|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.7||||0.0028|TWO_SIDED|95.0|-5.53|-1.87||Multiplicity is addressed for the two co-primary effectiveness endpoints via a closed testing procedure where the time to hemostasis will be assessed first and then time to ambulation only if significance is first achieved for time to hemostasis.|t-test, 2 sided|||"Null hypothesis:The mean time to ambulation for the manual compression (MC) arm is less or equal to that for the vascular closure device (VCD) arm.~The trial is powered to detect a 5 minute reduction in mean time to hemostasis and a 2 hour reduction in mean time to ambulation for VCD vs. MC with over 90% power and a 5% two-sided (2.5% one-sided) Type I error"||-1.87|-5.53|0.0028
71057669|NCT00345631|141620564|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is adequate to rule out a 4% or larger disadvantage for VCD vs. MC (null hypothesis: 2.5% MC vs. 6.5% VCD) in the incidence of major complications for VCD vs. MC using a 95% upper confidence bound for the VCD - MC difference with 80% power and a 5% one-sided Type I error|Mean Difference (Final Values)|0.0||||0.0006|ONE_SIDED|95.0||1.14||P-value was calculated using unconditional exact test of non-inferiority for difference of two binomial proportions (VCD vs. MC) with a margin of 4%.|unconditional exact test|||Based on pre-planned hypotheses, a minimum sample size of 390 randomized patients (260 VCD patients and 130 MC patients) would demonstrate non-inferiority for the primary safety endpoint and superiority for both co-primary effectiveness endpoints in comparing VCD vs. MC.||1.14||0.0006
71057670|NCT00345631|141620565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7||||0.154|TWO_SIDED|95.0|-7.84|0.45|||t-test, 2 sided|||Null hypothesis: The mean time to eligibility for hospital discharge for the manual compression (MC) arm is equal to that for the vascular closure device (VCD) arm.||0.45|-7.84|0.1540
71057671|NCT00345631|141620566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.57||||0.3612|TWO_SIDED|95.0|-7.46|2.31|||t-test, 2 sided|||Null hypothesis: The mean time to hospital discharge for the manual compression (MC) arm is equal to that for the vascular closure device (VCD) arm.||2.31|-7.46|0.3612
71057672|NCT00345631|141620569|SUPERIORITY_OR_OTHER||Proportion difference|0.7||||0.85|TWO_SIDED|95.0|-4.8|7.4|||t-test, 2 sided|||Null hypothesis: The percentages of patients achieving procedure success between the vascular closure device and manual compression arms are equal.||7.4|-4.8|0.85
71057673|NCT00509795|141620616|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%. The power is 90% according to the sample size estimation of the study protocol. Although not in the analysis plan for the study, in a separate communication, the FDA further explained that, whereas the 10% non-inferiority margin would be used to assess non-inferiority, a 5% non-inferiority margin would be used to assess clinical equivalence.|Risk Difference (RD)|-0.7|||||TWO_SIDED|95.1|-4.4|3.1|||||The difference is calculated as ranibizumab minus IAI. A positive value favors IAI 2.0Q4. As adjustment of multiple comparisons as conditional sequence of statistical hypotheses is used with alpha = 0.049.|The statistical approach included a conditional sequence of calculations of the 95.1% CI using normal approximation of the difference between the proportion of patients with maintained vision at Week 52 for the group treated with 0.5 mg ranibizumab and the proportion of patients with maintained vision for each of the groups treated with IAI.||3.1|-4.4|
71057674|NCT00509795|141620616|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%. The power is 90% according to the sample size estimation of the study protocol. Although not in the analysis plan for the study, in a separate communication, the FDA further explained that, whereas the 10% non-inferiority margin would be used to assess non-inferiority, a 5% non-inferiority margin would be used to assess clinical equivalence.|Risk Difference (RD)|-1.5|||||TWO_SIDED|95.1|-5.1|2.1|||||The difference is calculated as ranibizumab minus IAI. A negative value favors the IAI 0.5Q4 group. As adjustment of multiple comparisons as conditional sequence of statistical hypotheses is used with alpha = 0.049.|The statistical approach included a conditional sequence of calculations of the 95.1% CI using normal approximation of the difference between the proportion of patients with maintained vision at Week 52 for the group treated with 0.5 mg ranibizumab and the proportion of patients with maintained vision for each of the groups treated with IAI (EYLEA, VEGF Trap-Eye).||2.1|-5.1|
71108110|NCT02941614|141721627|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.12||||0.35|TWO_SIDED|95.0|-0.36|0.13|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Weight Problems Sub-Scale||0.13|-0.36|0.35
71108111|NCT02941614|141721627|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.12||||0.34|TWO_SIDED|95.0|-0.36|0.12|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Weight Problems Sub-Scale||0.12|-0.36|0.34
70934692|NCT00887224|141369856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||<|0.001|TWO_SIDED|95.0|0.17|0.49||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 18||0.49|0.17|<0.001
70934693|NCT00887224|141369856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43|||<|0.001|TWO_SIDED|95.0|0.25|0.62||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 22||0.62|0.25|<0.001
70934694|NCT00887224|141369856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|||<|0.001|TWO_SIDED|95.0|0.28|0.61||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26||0.61|0.28|<0.001
70934695|NCT00887224|141369857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.8853|TWO_SIDED|95.0|-0.41|0.47||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 1||0.47|-0.41|0.8853
71024922|NCT00294723|141556880|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-0.75||||0.0642||95.0|-1.55|0.05||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous anti-diabetic treatment as fixed effects and baseline body weight as covariance.||0.05|-1.55|0.0642
70934696|NCT00887224|141369857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.88||||0.0081|TWO_SIDED|95.0|0.23|1.52||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 2||1.52|0.23|0.0081
70934697|NCT00887224|141369857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.88||||0.0038|TWO_SIDED|95.0|0.28|1.47||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 3||1.47|0.28|0.0038
70934698|NCT00887224|141369857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|||<|0.001|TWO_SIDED|95.0|0.76|2.03||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 4||2.03|0.76|<0.001
70934699|NCT00887224|141369857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63|||<|0.001|TWO_SIDED|95.0|0.86|2.39||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 6||2.39|0.86|<0.001
71024923|NCT00294723|141556881|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-20.28|||<|0.0001||95.0|-29.09|-11.46||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-11.46|-29.09|<.0001
71024924|NCT00294723|141556881|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-9.92||||0.027||95.0|-18.7|-1.12||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-1.12|-18.70|0.0270
70934700|NCT00887224|141369857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68|||<|0.001|TWO_SIDED|95.0|0.83|2.54||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 10||2.54|0.83|<0.001
71057675|NCT00509795|141620616|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%. The power is 90% according to the sample size estimation of the study protocol. Although not in the analysis plan for the study, in a separate communication, the FDA further explained that, whereas the 10% non-inferiority margin would be used to assess non-inferiority, a 5% non-inferiority margin would be used to assess clinical equivalence.|Risk Difference (RD)|-0.7|||||TWO_SIDED|95.1|-4.5|3.1|||||The difference is calculated as ranibizumab minus IAI. A negative value favors the IAI 2.0Q8 group. As adjustment of multiple comparisons as conditional sequence of statistical hypotheses is used with alpha = 0.049.|The statistical approach included a conditional sequence of calculations of the 95.1% CI using normal approximation of the difference between the proportion of patients with maintained vision at Week 52 for the group treated with 0.5 mg ranibizumab and the proportion of patients with maintained vision for each of the groups treated with IAI (EYLEA, VEGF Trap-Eye).||3.1|-4.5|
71057676|NCT00509795|141620617|SUPERIORITY_OR_OTHER||Differences in Least Squares means|3.15||||0.0054|TWO_SIDED|95.1|0.92|5.37||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||5.37|0.92|0.0054
71024925|NCT00294723|141556881|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-10.36||||0.0223||95.0|-19.24|-1.48||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-1.48|-19.24|0.0223
71024926|NCT00294723|141556882|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-17.79||||0.0003||95.0|-27.48|-8.09||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-8.09|-27.48|0.0003
71024927|NCT00294723|141556882|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-11.33||||0.0217||95.0|-20.99|-1.66||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-1.66|-20.99|0.0217
71024928|NCT00294723|141556882|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg|Estimated treatment difference, LS Mean|-6.46||||0.1942||95.0|-16.23|3.3||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||3.30|-16.23|0.1942
71024929|NCT00294723|141556883|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-16.63||||0.0007||95.0|-26.19|-7.06||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-7.06|-26.19|0.0007
71024930|NCT00294723|141556883|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-10.02||||0.0395||95.0|-19.56|-0.49||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-0.49|-19.56|0.0395
71024931|NCT00294723|141556883|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-6.6||||0.1789||95.0|-16.24|3.03||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||3.03|-16.24|0.1789
71024932|NCT00294723|141556884|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-12.9||||0.0038||95.0|-21.6|-4.2||2-sided significance level 5%|ANCOVA|||Change in mean postprandial glucose (PPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||-4.2|-21.6|0.0038
71024933|NCT00294723|141556884|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-6.3||||0.1616||95.0|-15.0|2.5||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||2.5|-15.0|0.1616
71057677|NCT00509795|141620617|SUPERIORITY_OR_OTHER||Differences in Least Squares means|0.8||||0.4793|TWO_SIDED|95.1|-3.03|1.43||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 0.5Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||1.43|-3.03|0.4793
71117626|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
70941684|NCT04748445|141383934|OTHER||Slope|0.03559|STANDARD_ERROR_OF_MEAN|1.147||0.7568|TWO_SIDED|90.0|-0.1545|0.2256|||Mixed Models Analysis|||READ\_MFCC mean 02 (The statistical data given below have (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||0.2256|-0.1545|0.7568
71057678|NCT00509795|141620617|SUPERIORITY_OR_OTHER||Differences in Least Squares Means|0.26||||0.8179|TWO_SIDED|95.1|-1.97|2.49||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q8.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||2.49|-1.97|0.8179
70851724|NCT01808092|141191383|NON_INFERIORITY_OR_EQUIVALENCE|The statistical test of NI for the primary efficacy analysis will be performed at the 2.5% 1 sided significance level. This test will be based on the lower limit of a 2-sided 95% confidence interval (CI). Consistent with the protocol, NI will be concluded if the lower limit of the 95% CI is greater than -12.5%.|percentage: units for RD are %|-4.2||||0.007|TWO_SIDED|95.0|-10.76|2.46||P-value for 1-sided test at test of cure (TOC) with a -12.5% non-inferiority margin, i.e. H0: diff \<= -12.5%.|% Risk Difference (RD)|RD is CAZ-AVI clinical cure rate minus Meropenem clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.||Statistical analysis for the proportion of patients with clinical cure at TOC in cMITT analysis set||2.46|-10.76|0.007
70851725|NCT01808092|141191384|NON_INFERIORITY_OR_EQUIVALENCE|The statistical test of NI for the primary efficacy analysis will be performed at the 2.5% 1 sided significance level. This test will be based on the lower limit of a 2-sided 95% confidence interval (CI). Consistent with the protocol, NI will be concluded if the lower limit of the 95% CI is greater than -12.5%.|percentage: units for RD are %|-0.7|||<|0.001|TWO_SIDED|95.0|-7.86|6.39||P-value for 1-sided test at test of cure (TOC) with a -12.5% non-inferiority margin, i.e. H0: diff \<= -12.5%.|% Risk Difference (RD)|RD is CAZ-AVI clinical cure rate minus Meropenem clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.||Statistical analysis for the proportion of patients with clinical cure at TOC in CE at TOC analysis set||6.39|-7.86|<0.001
70851726|NCT01909011|141191435|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
70851727|NCT01909011|141191436|SUPERIORITY_OR_OTHER|||||||0.066|TWO_SIDED||||||t-test, 2 sided|||||||0.066
70851728|NCT01909011|141191437|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||t-test, 2 sided|||||||0.016
70851729|NCT00695097|141191438|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||P \< 0.05 threshold of significance|t-test, 2 sided|||Pretreatment (Baseline)compared to post-treatment (follow-up) CD3 cell density||||0.25
70851730|NCT00695097|141191438|SUPERIORITY_OR_OTHER|||||||0.46||95.0||||P \< 0.05 threshold of significance|t-test, 2 sided|||Pretreatment (Baseline) compared to post-treatment (follow-up) CD3 cell density||||0.46
70851731|NCT00695097|141191438|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||P \< 0.05 threshold of significance|t-test, 2 sided|||pretreatment (baseline) compared to post-treatment (follow-up) biopsy CD20 cell density||||0.054
70851732|NCT00695097|141191438|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||P \< 0.05 threshold of significance|t-test, 2 sided|||Pretreatment (baseline) compared to post-treatment (follow-up) CD20 cell density||||0.62
70851733|NCT05141448|141191490|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the 95% confidence interval of was below 0.05 logMAR|Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.011|||TWO_SIDED|95.0|0.02|0.06|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Mean difference was calculated as senofilcon A C3 (EMO-118) minus omafilcon A|||0.06|0.02|
70851734|NCT02248675|141191505|SUPERIORITY_OR_OTHER|||||||0.153|||||||Regression, Linear|multiple regression controlling for baseline values of the dependent variable was used to examine between group effects at post-treatment||||||.153
70934701|NCT00887224|141369857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.04|||<|0.001|TWO_SIDED|95.0|1.23|2.86||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14||2.86|1.23|<0.001
70851735|NCT02248675|141191506|SUPERIORITY_OR_OTHER|||||||0.627|||||||Regression, Linear|||||||.627
70851736|NCT02248675|141191507|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Linear|multiple regression controlling for baseline values of the dependent variable was used to examine between group effects at post-treatment||||||<.001
70851737|NCT02248675|141191508|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Linear|multiple regression controlling for baseline values of the dependent variable was used to examine between group effects at post-treatment||||||<.001
70934702|NCT00887224|141369857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.95|||<|0.001|TWO_SIDED|95.0|1.06|2.84||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 18||2.84|1.06|<0.001
70851738|NCT00813943|141191523|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.686||||0.0328|TWO_SIDED|95.0|0.484|0.972||P-value is not adjusted for multiple testing.|Log Rank|||||0.972|0.484|0.0328
70851739|NCT00813943|141191523|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.858||||0.3771|TWO_SIDED|95.0|0.612|1.204||P-value is not adjusted for multiple testing.|Log Rank|||||1.204|0.612|0.3771
70851740|NCT00984620|141191543|SUPERIORITY_OR_OTHER||Adjusted percent difference|-1.25||||0.855|TWO_SIDED|95.0|-14.3|11.8|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).|p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).|||11.8|-14.3|0.855
70851741|NCT00984620|141191544|SUPERIORITY_OR_OTHER||Adjusted percent difference|9.02||||0.229|TWO_SIDED|95.0|-5.3|23.3|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).|p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).|||23.3|-5.3|0.229
70851742|NCT00984620|141191545|SUPERIORITY_OR_OTHER||Adjusted percent difference|5.48||||0.417|TWO_SIDED|95.0|-7.3|18.3|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).|p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).|||18.3|-7.3|0.417
70851743|NCT00984620|141191546|SUPERIORITY_OR_OTHER||Adjusted percent difference|2.99||||0.676|TWO_SIDED|95.0|-10.6|16.6|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).|p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).|||16.6|-10.6|0.676
70934703|NCT00887224|141369857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|||<|0.001|TWO_SIDED|95.0|1.31|3.3||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 22||3.30|1.31|<0.001
70934704|NCT00887224|141369857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.35|||<|0.001|TWO_SIDED|95.0|1.39|3.32||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26||3.32|1.39|<0.001
70934705|NCT00887224|141369858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9142|TWO_SIDED|95.0|-0.24|0.27||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 1||0.27|-0.24|0.9142
70934706|NCT00887224|141369858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53||||0.0069|TWO_SIDED|95.0|0.15|0.91||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 2||0.91|0.15|0.0069
70934707|NCT00887224|141369858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58||||0.0023|TWO_SIDED|95.0|0.21|0.95||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 3||0.95|0.21|0.0023
70934708|NCT00887224|141369858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89|||<|0.001|TWO_SIDED|95.0|0.49|1.28||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 4||1.28|0.49|<0.001
71057679|NCT00509795|141620618|SUPERIORITY_OR_OTHER||Risk Difference (RD)|6.6||||0.1042|TWO_SIDED|95.1|-1.0|14.1||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049.|Chi-squared||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q4.|The null hypothesis is that both percentages are equal.||14.1|-1.0|0.1042
70851744|NCT00984620|141191547|SUPERIORITY_OR_OTHER||Adjusted percent difference|3.24||||0.588|TWO_SIDED|95.0|-8.1|14.6|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).|p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).|||14.6|-8.1|0.588
70934709|NCT00887224|141369858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.88|||<|0.001|TWO_SIDED|95.0|0.43|1.32||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 6||1.32|0.43|<0.001
70934710|NCT00887224|141369858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08|||<|0.001|TWO_SIDED|95.0|0.58|1.58||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 10||1.58|0.58|<0.001
70934711|NCT00887224|141369858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|||<|0.001|TWO_SIDED|95.0|0.66|1.58||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14||1.58|0.66|<0.001
70934712|NCT00887224|141369858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|||<|0.001|TWO_SIDED|95.0|0.76|1.83||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 18||1.83|0.76|<0.001
70934713|NCT00887224|141369858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.23|||<|0.001|TWO_SIDED|95.0|0.7|1.76||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 22||1.76|0.70|<0.001
70934714|NCT00887224|141369858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.27|||<|0.001|TWO_SIDED|95.0|0.75|1.79||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26||1.79|0.75|<0.001
70934715|NCT00887224|141369859|SUPERIORITY_OR_OTHER||Adjusted odds ratio|2.85|||<|0.0001|TWO_SIDED|95.0|1.93|4.2||Obtained from logistic regression analysis using Remission (Yes/No) at each time point as a response variable; logistic model with treatment and sites as factors and baseline HAM-D17 total score as covariate.|Regression, Logistic|||Wald 95% CI for adjusted odds ratio.||4.20|1.93|<0.0001
70934716|NCT00887224|141369860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.14|||<|0.001|TWO_SIDED|95.0|-3.03|-1.24||"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14||-1.24|-3.03|<0.001
70934717|NCT00887224|141369860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.32|||<|0.001|TWO_SIDED|95.0|-3.29|-1.34||"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26||-1.34|-3.29|<0.001
70934718|NCT00887224|141369861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02||||0.6772|TWO_SIDED|95.0|-3.82|5.87||"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14 Absenteeism||5.87|-3.82|0.6772
71057680|NCT00509795|141620618|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-6.0||||0.1037|TWO_SIDED|95.1|-13.2|1.2||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049.|Chi-squared||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 0.5Q4.|The null hypothesis is that both percentages are equal.||1.2|-13.2|0.1037
71057681|NCT00509795|141620618|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.4||||0.93|TWO_SIDED|95.1|-7.7|7.0||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049.|Chi-squared||The difference is calculated as VEGF Trap-Eye minus ranibizumab. A positive value favors VEGF Trap-Eye 2.0Q8.|The pairwise The null hypothesis is that both percentages are equal.||7.0|-7.7|0.93
71057682|NCT00509795|141620619|SUPERIORITY_OR_OTHER||Differences Least Squares means|1.28||||0.209|TWO_SIDED|95.1|-0.73|3.28||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||3.28|-0.73|0.2090
71057683|NCT00509795|141620619|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.67||||0.5128|TWO_SIDED|95.1|-2.69|1.35||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 0.5Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||1.35|-2.69|0.5128
71057684|NCT00509795|141620619|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.6||||0.5579|TWO_SIDED|95.1|-2.61|1.42||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q8.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||1.42|-2.61|0.5579
71057685|NCT00509795|141620620|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.33||||0.3575|TWO_SIDED|95.1|-1.04|0.38||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A negative value favors IAI 2.0Q4|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||0.38|-1.04|0.3575
71057686|NCT00509795|141620620|SUPERIORITY_OR_OTHER||Differences in Least Squares means|0.71||||0.0507|TWO_SIDED|95.1|-0.01|1.42||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A negative value favors IAI 0.5Q4|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||1.42|-0.01|0.0507
71057687|NCT00509795|141620620|SUPERIORITY_OR_OTHER||Differences in Least Squares means|0.86||||0.0173|TWO_SIDED|95.1|0.15|1.58||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A negative value favors IAI 2.0Q8|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||1.58|0.15|0.0173
71057688|NCT04324073|141620676|SUPERIORITY||Median posterior absolute risk differenc|0.2|||||TWO_SIDED|90.0|-11.7|12.2||Posterior probability|Bayesian analysis|Adjusted for age and centre|% Confidence Interval is % Credibility interval here|||12.2|-11.7|
71057689|NCT04324073|141620677|SUPERIORITY||Median posterior Hazard Ratio|1.1|||||TWO_SIDED|90.0|0.69|1.74||Posterior probability|Bayesian analysis|HR adjusted for age and centre|% Confidence interval is % Credible interval here|||1.74|0.69|
71057690|NCT04324073|141620678|SUPERIORITY||Median posterior absolute risk differenc|-7.3|||||TWO_SIDED|90.0|-22.5|8.7||Posterior probability|Bayesian analysis|Adjusted on age and centre|% Confidence Interval is %Credible Interval here. Results are presented as the proportion not improved, so that an effective treatment would be associated with a decrease in proportion.|||8.7|-22.5|
71057691|NCT04324073|141620679|SUPERIORITY||Median posterior Hazard Ratio|1.05|||||TWO_SIDED|90.0|0.55|2.07||Posterior probability|Bayesian analysis||% Confidence Interval is % Credible Interval here|||2.07|0.55|
71057692|NCT04324073|141620680|SUPERIORITY|Day 14|Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.23|2.03|||Regression, Cox|adjusted for age and sex||||2.03|0.23|
71057693|NCT04324073|141620680|SUPERIORITY||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.27|1.59|||Regression, Cox|||Day 28||1.59|0.27|
71057694|NCT04324073|141620680|SUPERIORITY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.31|1.58|||Regression, Cox|||Day 90||1.58|0.31|
71057695|NCT04324073|141620680|SUPERIORITY||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.4|2.25|||Regression, Cox|||Day 14||2.25|0.40|
71057696|NCT04324073|141620680|SUPERIORITY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.4|1.96|||Regression, Cox|||Day 28||1.96|0.40|
71057697|NCT04324073|141620680|SUPERIORITY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.35|1.58|||Regression, Cox|||Day 90||1.58|0.35|
71057698|NCT04324073|141620681|SUPERIORITY||Median posterior OR|1.11|||||TWO_SIDED|95.0|0.53|2.34|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre.|% Confidence Interval is % Credible Interval here|Day 4||2.34|0.53|
71057699|NCT04324073|141620681|SUPERIORITY||Median posterior OR|1.02|||||TWO_SIDED|95.0|0.49|2.08|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre.|% Confidence Interval is % Credible Interval here|Day 7||2.08|0.49|
71024934|NCT00294723|141556884|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-6.6||||0.1319||95.0|-15.3|2.0||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||2.0|-15.3|0.1319
71057700|NCT04324073|141620681|SUPERIORITY||Median posterior OR|0.79|||||TWO_SIDED|95.0|0.42|1.47|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre.|% Confidence Interval is % Credible Interval here|Day 14||1.47|0.42|
71057701|NCT04324073|141620681|SUPERIORITY||Median posterior OR|0.88|||||TWO_SIDED|95.0|0.38|2.02|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre.|% Confidence Interval is % Credible Interval here|Day 4||2.02|0.38|
71057702|NCT04324073|141620681|SUPERIORITY||Median posterior OR|1.07|||||TWO_SIDED|95.0|0.47|2.4|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre.|% Confidence Interval is % Credible Interval here|Day 14||2.40|0.47|
71057703|NCT04324073|141620681|SUPERIORITY||Median posterior OR|1.13|||||TWO_SIDED|95.0|0.5|2.57|||Proportionnal odds model|Bayesian analysis. Adjusted for age and sex|% Confidence Interval is % Credible Interval here|Day 90||2.57|0.50|
71057704|NCT04324073|141620682|SUPERIORITY||Median Difference (Net)|-1.5|||||TWO_SIDED|95.0|-6.1|3.9||||adjusted on age and centre||||3.9|-6.1|
71057705|NCT04324073|141620683|SUPERIORITY||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.72|1.57|||Fine-Gray model|adjusted for age and centre||Day 28||1.57|0.72|
71057706|NCT04324073|141620683|SUPERIORITY||Hazard Ratio (HR)|1.29|||||TWO_SIDED|95.0|0.74|2.25|||Fine-Gray model|Adjusted for age and centre||Day 90||2.25|0.74|
71057707|NCT04324073|141620683|SUPERIORITY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.59|2.44|||Fine-Gray model|adjusted for age and centre||Day 28||2.44|0.59|
71057708|NCT04324073|141620683|SUPERIORITY||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.74|1.55|||Fine-Gray model|Adjusted for age and centre||Day 90||1.55|0.74|
71108112|NCT02941614|141721627|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.09||||0.22|TWO_SIDED|95.0|-0.06|0.25|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Arm Problems Sub-Scale||0.25|-0.06|0.22
70934719|NCT00887224|141369861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.9059|TWO_SIDED|95.0|-5.91|5.24||"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26 Absenteeism||5.24|-5.91|0.9059
71057709|NCT04324073|141620684|SUPERIORITY||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.81|1.75|||Fine-Gray model|Adjusted on age and centre||Day 28||1.75|0.81|
71057710|NCT04324073|141620684|SUPERIORITY||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.8|1.67|||Fine-Gray model|Adjusted on age and centre||Day 90||1.67|0.80|
71057711|NCT04324073|141620684|SUPERIORITY||Hazard Ratio (HR)|1.21|||||TWO_SIDED|95.0|0.55|2.66|||Fine-Gray model|Adjusted on age and centre||Day 28||2.66|0.55|
71057712|NCT04324073|141620684|SUPERIORITY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.71|2.37|||Fine-Gray model|Adjusted on age and centre||Day 90||2.37|0.71|
71057713|NCT04324073|141620685|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.42|1.44|||Fine-Gray model|Adjusted for age and centre||Day 28||1.44|0.42|
71057714|NCT04324073|141620685|SUPERIORITY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.49|1.47|||Fine-Gray model|adjusted for age and centre||Day 90||1.47|0.49|
71057715|NCT05833139|141620687|OTHER||Geometric mean ratio (T/R) [%]|141.2|||||TWO_SIDED|90.0|126.3|157.7|||ANOVA||Intra-individual geometric coefficient of variation (gCV%) = 18.0|"The statistical model used was an analysis of variance (ANOVA) on the logarithmic scale. AUC0-∞ was log transformed (natural logarithm) prior to fitting the ANOVA model, considering the effect 'participant' as random and treatment as fixed."||157.7|126.3|
71057716|NCT05833139|141620688|OTHER||Geometric mean ratio (T/R) [%]|126.9|||||TWO_SIDED|90.0|106.6|151.0|||ANOVA||Intra-individual geometric coefficient of variation (gCV%) = 28.7|"The statistical model used was an analysis of variance (ANOVA) on the logarithmic scale. Cmax was log transformed (natural logarithm) prior to fitting the ANOVA model, considering the effect 'participant' as random and treatment as fixed."||151.0|106.6|
71057717|NCT05833139|141620689|OTHER||Geometric mean ratio (T/R) [%]|142.8|||||TWO_SIDED|90.0|126.0|161.9|||ANOVA||Intra-individual geometric coefficient of variation (gCV%) = 20.4|"The statistical model used was an analysis of variance (ANOVA) on the logarithmic scale. AUC0-tz was log transformed (natural logarithm) prior to fitting the ANOVA model, considering the effect 'participant' as random and treatment as fixed."||161.9|126.0|
71057718|NCT03922529|141620697|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.8||0.543|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.5430
71057719|NCT03922529|141620698|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.8||0.7625|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.7625
71057720|NCT03922529|141620699|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.7||0.8842|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.8842
71057721|NCT03922529|141620700|SUPERIORITY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|1.2||0.4086|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.4086
71057722|NCT03922529|141620701|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|1.2||0.3841|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.3841
70851745|NCT00984620|141191548|SUPERIORITY_OR_OTHER||Adjusted percent difference|4.78||||0.512|TWO_SIDED|95.0|-9.0|18.6|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).|p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).|||18.6|-9.0|0.512
70851746|NCT00984620|141191550|SUPERIORITY_OR_OTHER|||||||0.1397||||||Compare 120 MG Faldaprevir 120mg (24 Weeks) over 120 MG Faldaprevir 120mg (12 Weeks) using log-rank test.|Log Rank|||||||0.1397
70851747|NCT00470834|141191568|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Log Rank|||||||0.79
70851748|NCT00470834|141191568|SUPERIORITY_OR_OTHER||Relative Risk|0.94|||||TWO_SIDED|95.0|0.61|1.46|||||The hazard ratio is based on the Cox proportional hazards model.|||1.46|0.61|
70851749|NCT00470834|141191568|SUPERIORITY_OR_OTHER||Relative Risk Reduction|5.62|||||TWO_SIDED|95.0|-46.14|39.05|||||Relative Risk Reduction = 100 \* (1 - Relative Risk).|||39.05|-46.14|
71057723|NCT03922529|141620702|SUPERIORITY||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|1.2||0.1393|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|||The adjusted difference from a model may not necessarily match the raw difference between groups.|||0.1393
71057724|NCT03922529|141620703|SUPERIORITY||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|12.3||0.9257|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.9257
71057725|NCT03922529|141620704|SUPERIORITY||Mean Difference (Final Values)|-5.2|STANDARD_ERROR_OF_MEAN|11.8||0.6588|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.6588
71057726|NCT03922529|141620705|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|13.0||0.992|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.9920
71057727|NCT03922529|141620706|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9504|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.9504
71057728|NCT03922529|141620707|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.6228|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.6228
71057729|NCT03922529|141620708|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7966|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.7966
71057730|NCT03922529|141620709|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.5071|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.5071
71057731|NCT03922529|141620710|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.5553|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.5553
71057732|NCT03922529|141620711|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1194|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.1194
71057733|NCT03922529|141620712|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.8||0.9012|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.9012
71057734|NCT03922529|141620713|SUPERIORITY||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.9||0.4279|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.4279
71057735|NCT03922529|141620714|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|0.8||0.1932|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.1932
71057736|NCT03922529|141620715|SUPERIORITY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|1.2||0.2723|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.2723
71057737|NCT03922529|141620716|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|1.2||0.8951|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.8951
71057738|NCT03922529|141620717|SUPERIORITY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|1.2||0.2574|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.2574
70934720|NCT00887224|141369861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.91||||0.0414|TWO_SIDED|95.0|0.27|13.55||"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14 Presenteeism||13.55|0.27|0.0414
70934721|NCT00887224|141369861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.24||||0.0129|TWO_SIDED|95.0|1.77|14.71||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26 Presenteeism||14.71|1.77|0.0129
70934722|NCT00887224|141369861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.48||||0.0402|TWO_SIDED|95.0|0.34|14.61||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14 Work Productivity Loss||14.61|0.34|0.0402
70934723|NCT00887224|141369861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.48||||0.0187|TWO_SIDED|95.0|1.43|15.53||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26 Work Productivity Loss||15.53|1.43|0.0187
70934724|NCT00887224|141369861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.57|||<|0.001|TWO_SIDED|95.0|3.33|11.8||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14 Activity Impairment||11.80|3.33|<0.001
71024935|NCT00294723|141556885|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-12.3||||0.0105||95.0|-21.71|-2.89||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||-2.89|-21.71|0.0105
71024936|NCT00294723|141556885|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-2.49||||0.606||95.0|-11.95|6.98||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||6.98|-11.95|0.6060
71024937|NCT00294723|141556885|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-9.81||||0.0392||95.0|-19.14|-0.49||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||-0.49|-19.14|0.0392
71024938|NCT00294723|141556886|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-10.98||||0.0227||95.0|-20.42|-1.54||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||-1.54|-20.42|0.0227
71024939|NCT00294723|141556886|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-1.83||||0.7047||95.0|-11.33|7.66||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||7.66|-11.33|0.7047
71024940|NCT00294723|141556886|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-9.15||||0.0553||95.0|-18.51|0.21||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||0.21|-18.51|0.0553
71024941|NCT00294723|141556887|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided 95% confidence interval (CI) for the treatment difference \[liraglutide - glimepiride\] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete CI was below 0%.|Estimated treatment difference, LS Mean|-0.55|||<|0.0001||95.0|-0.77|-0.34||The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity. 2-sided significance level was 5%.|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.34|-0.77|<0.0001
71057739|NCT03922529|141620718|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|1.0||0.8307|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.8307
71024942|NCT00294723|141556887|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided 95% confidence interval (CI) for the treatment difference \[liraglutide - glimepiride\] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete CI was below 0%. Superiority of 1.2 mg liraglutide was only tested if 1.2 mg liraglutide was non-inferior to glimepiride and 1.8 mg liraglutide was superior to glimepiride.|Estimated treatment difference, LS Mean|-0.28||||0.0122||95.0|-0.49|-0.06||The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity. 2-sided significance level was 5%.|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.06|-0.49|0.0122
70934725|NCT00887224|141369861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.62|||<|0.001|TWO_SIDED|95.0|3.14|12.1||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26 Activity Impairment||12.10|3.14|<0.001
70934726|NCT03883828|141369862|SUPERIORITY||Multivariable Linear Regression|-0.45||||0.004|TWO_SIDED|95.0|-0.75|-0.15||Two-sided p-values equal to or less than 0.05 were considered statistically significant|Fisher Exact|||||-0.15|-0.75|0.004
71024943|NCT00294723|141556887|NON_INFERIORITY_OR_EQUIVALENCE|A test for superiority of liraglutide 1.8 mg to liraglutide 1.2 mg was performed to compare the two doses. Superiority of liraglutide 1.8 mg was concluded if the upper limit of the 2-sided 95% CI for the treatment difference (liraglutide 1.8 mg - liraglutide 1.2 mg) was below 0%.|Estimated treatment difference, LS Mean|-0.28||||0.0123||95.0|-0.49|-0.06||2-sided significance level 5%|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.06|-0.49|0.0123
71024944|NCT00294723|141556888|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-4.0||||0.1396||95.0|-9.4|1.3||2-sided significance level 5%|ANCOVA|||Change in mean prandial increments of plasma glucose from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||1.3|-9.4|0.1396
71024945|NCT00294723|141556888|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-2.9||||0.2968||95.0|-8.3|2.5||2-sided significance level 5%|ANCOVA|||Change in mean prandial increments of plasma glucose from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||2.5|-8.3|0.2968
71057740|NCT03922529|141620719|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|1.0||0.614|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.6140
71057741|NCT03922529|141620720|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|1.0||0.7327|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.7327
71057742|NCT03922529|141620721|SUPERIORITY|||||||0.7651|||||||Wilcoxon rank sum|||||||0.7651
71057743|NCT03922529|141620722|SUPERIORITY||Incident Rate Ratio|1.15||||0.3974|TWO_SIDED|95.0|0.83|1.59|||Negative binomial regression models|||||1.59|0.83|0.3974
71057744|NCT03922529|141620723|SUPERIORITY||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|1.5||0.2727|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.2727
71057745|NCT03922529|141620724|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.5||0.4269|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.4269
71057746|NCT03922529|141620725|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.6||0.4354|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.4354
71057747|NCT03922529|141620726|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.4||0.8695|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.8695
71057748|NCT03922529|141620727|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.4||0.7075|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.7075
71057749|NCT03922529|141620728|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.8936|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.8936
70934727|NCT03883828|141369863|SUPERIORITY|||||||0.2||||||A 2-sided P ≤ .05 was considered statistically significant|Wilcoxon (Mann-Whitney)|Symptoms Domain||||||0.20
70934728|NCT03883828|141369863|SUPERIORITY|||||||0.05||||||A 2-sided P ≤ .05 was considered statistically significant|Wilcoxon (Mann-Whitney)|Emotions Domain||||||0.05
70851750|NCT00244140|141191573|SUPERIORITY_OR_OTHER||Percent Images Rated Good/Excellent: BR1|95.8||||||95.0|93.3|97.6||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 1 (BR1).||97.6|93.3|
70934729|NCT03883828|141369863|SUPERIORITY|||||||0.73||||||A 2-sided P ≤ .05 was considered statistically significant|Wilcoxon (Mann-Whitney)|Functioning Domain||||||0.73
71024946|NCT00294723|141556888|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-1.2||||0.6639||95.0|-6.5|4.1||2-sided significance level 5%|ANCOVA|||Change in postprandial (PPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||4.1|-6.5|0.6639
71024947|NCT00294723|141556889|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.81||||0.172||95.0|-9.28|1.66||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||1.66|-9.28|0.1720
71024948|NCT00294723|141556889|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-0.33||||0.906||95.0|-5.82|5.16||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||5.16|-5.82|0.9060
71024949|NCT00294723|141556889|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-3.48||||0.2089||95.0|-8.91|1.95||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||1.95|-8.91|0.2089
71024950|NCT00294723|141556890|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.04||||0.2749||95.0|-8.51|2.42||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||2.42|-8.51|0.2749
71057750|NCT03922529|141620729|SUPERIORITY|||||||0.2794|||||||Chi-squared|||||||0.2794
71057751|NCT03922529|141620730|SUPERIORITY|||||||0.6177|||||||Chi-squared|||||||0.6177
70851751|NCT00244140|141191573|SUPERIORITY_OR_OTHER||Percent Images Rated Good/Excellent: BR2|96.3||||||95.0|93.9|98.0||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 2 (BR2).||98.0|93.9|
70851752|NCT00244140|141191573|SUPERIORITY_OR_OTHER||Percent Images Rated Good/Excellent: BR3|98.4||||||95.0|96.6|99.4||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 3 (BR3).||99.4|96.6|
70851753|NCT00244140|141191574|SUPERIORITY_OR_OTHER||Percent Images Rated Yes|99.7||||||95.0|98.6|100.0||||||||100.0|98.6|
70851754|NCT00244140|141191575|SUPERIORITY_OR_OTHER||Percent Images Rated Good/Excellent|99.5||||||95.0|98.1|99.9||||||||99.9|98.1|
70934730|NCT01256359|141369864|SUPERIORITY||Hazard Ratio (HR)|0.753||||0.13|TWO_SIDED|90.0|0.498|1.138||p value \< 0.1 one-sided considered to be significant.|Regression, Cox||HR is Adjusted for M status, performance status|||1.138|0.498|0.130
70934731|NCT01256359|141369864|SUPERIORITY||Hazard Ratio (HR)|0.723||||0.113|TWO_SIDED|90.0|0.465|1.123|||Regression, Cox||This includes all 83 patients but the analysis additionally adjusted for LDH, target lesion sum and time interval between randomisation and baseline CT scan as well as mstatus, performance status|This is a sensitivity analysis of the primary outcome. This includes all 83 patients but the analysis additionally adjusted for LDH, target lesion sum and time interval between randomisation and baseline CT scan as well as mstatus, performance status||1.123|0.465|0.113
71057752|NCT03922529|141620731|SUPERIORITY|||||||0.144|||||||Chi-squared|||||||0.1440
71057753|NCT03922529|141620732|SUPERIORITY|||||||0.1122|||||||Chi-squared|||||||0.1122
71057754|NCT03922529|141620733|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9653|TWO_SIDED|95.0|0.63|1.62|||Regression, Logistic|||||1.62|0.63|0.9653
70934732|NCT01256359|141369864|SUPERIORITY|||||||0.3016||||||This analysis assesses if allowing for interval censoring is consistent with the primary outcome results.|Generalised log-rank|Generalised log-rank taking into account interval censoring, analysed using SAS package version 9.2. Method by Zhao and Sun, 2004||This is a sensitivity analysis, including all 83 randomised patients. Patients are assessed periodically for the response (progression), the time when the event occurred is not directly observed but is known to take place within some time interval. Progression is known only to have occurred at some time between visits, the exact time is not known. We carried out interval censored analysis to demonstrate if allowing for interval censoring gives a different interpretation of the primary outcome.||||0.3016
70934733|NCT01256359|141369864|SUPERIORITY||Hazard Ratio (HR)|1.348||||0.305|TWO_SIDED|90.0|0.602|3.016|||Regression, Cox||Adjusted for centre|Sensitivity analysis adjusting for centre. All 83 randomised patients were included in analysis. Centres were the three biggest recruiters and all other 13 centres are combined.||3.016|0.602|0.305
71024951|NCT00294723|141556890|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|0.43||||0.8765||95.0|-5.05|5.92||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||5.92|-5.05|0.8765
71024952|NCT00294723|141556890|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-3.48||||0.2088||95.0|-8.9|1.95||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||1.95|-8.90|0.2088
71108113|NCT02941614|141721627|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.11||||0.26|TWO_SIDED|95.0|-0.08|0.29|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Arm Problems Sub-Scale||0.29|-0.08|0.26
71108114|NCT02941614|141721627|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.09||||0.34|TWO_SIDED|95.0|-0.09|0.27|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Arm Problems Sub-Scale||0.27|-0.09|0.34
71024953|NCT00752791|141556893|SUPERIORITY_OR_OTHER||Mean change from Baseline|0.1|||||TWO_SIDED|95.0|-0.24|0.44|||||A two-sided 95% CI of the estimated mean change from Baseline in hemoglobin was derived from the t-distribution.|||0.44|-0.24|
71024954|NCT02784106|141556935|SUPERIORITY||Difference in Proportion of Responders|0.1|||||TWO_SIDED|80.0|-0.07|0.25||||||||0.25|-0.07|
71024955|NCT02784106|141556936|SUPERIORITY||Difference in Mean Changes|-1.93|||||TWO_SIDED|80.0|-5.54|1.69||||||||1.69|-5.54|
71024956|NCT02784106|141556937|SUPERIORITY||Difference in Proportion of Responders|-0.04|||||TWO_SIDED|80.0|-0.13|0.06||||||Day 28||0.06|-0.13|
71024957|NCT02784106|141556937|SUPERIORITY||Difference in Proportion of Responders|-0.04|||||TWO_SIDED|80.0|-0.18|0.09||||||Day 56||0.09|-0.18|
71057755|NCT03785600|141620736|OTHER||||||<|0.02||||||a priori threshold is \<0.05.|t-test, 2 sided|||||||<0.02
71057756|NCT01272037|141620770|OTHER||Hazard Ratio (HR)|1.02||||0.35|TWO_SIDED|95.0|0.98|1.05|||Regression, Cox|A Cox model was used that included treatment arm, recurrence score, menopausal status, and the chemotherapy\*recurrence score interaction term.||This test describes the interaction of the treatment arm with the recurrence score in the analysis of invasive disease-free survival in the overall study population, to determine whether chemotherapy benefit depends on the recurrence score. If the interaction was statistically significant, the interaction term was planned to be included in the Cox model to evaluate the invasive disease-free survival outcome.||1.05|0.98|0.35
70851755|NCT00244140|141191576|SUPERIORITY_OR_OTHER||Percent Images Rated Yes: BR1|98.4||||||95.0|96.6|99.4||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 1 (BR1).||99.4|96.6|
70934734|NCT01256359|141369865|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.187|TWO_SIDED|90.0|-3.4|31.4|||Log Rank||This is the estimated difference in PFS rate i.e. % difference between arms|||31.4|-3.4|0.187
70934735|NCT01256359|141369866|SUPERIORITY||Hazard Ratio (HR)|1.373||||0.169|TWO_SIDED|90.0|0.797|2.369|||Regression, Cox|p value \< 0.1 one-sided considered to be significant.||||2.369|0.797|0.169
70934736|NCT01256359|141369867|SUPERIORITY|||||||0.059|||||||Chi-squared|||Objective response rate calculated as number of patients with CR or PR over all patients randomised.||||0.059
71024958|NCT02784106|141556937|SUPERIORITY||Difference in Proportion of Responders|-0.01|||||TWO_SIDED|80.0|-0.15|0.12||||||Day 84||0.12|-0.15|
71024959|NCT02784106|141556938|SUPERIORITY||Difference in Proportion of Responders|0.06|||||TWO_SIDED|80.0|0.01|0.14||||||Day 28||0.14|0.01|
71057757|NCT01272037|141620770|OTHER||Hazard Ratio (HR)|1.71||||0.008|TWO_SIDED|95.0|1.15|2.54|||Regression, Cox|A Cox model was used that included treatment arm, recurrence score, menopausal status, and the chemotherapy\*menopausal status interaction term.||This test describes the interaction of the treatment arm with menopausal status (one of the study stratification factors) in the analysis of invasive disease-free survival in the overall study population, to determine whether chemotherapy benefit depends on menopausal status. If the interaction was statistically significant, separate analyses of IDFS were planned to be conducted by menopausal status.||2.54|1.15|0.008
71108115|NCT02941614|141721628|OTHER||Rate Ratio|0.86||||0.006|TWO_SIDED|95.0|0.77|0.96|||Regression, Poisson|||||0.96|0.77|0.006
71108116|NCT02941614|141721629|OTHER||Rate Ratio|1.07||||0.356|TWO_SIDED|95.0|0.93|1.07|||Regression, Poisson|||||1.07|0.93|0.356
71024960|NCT02784106|141556938|SUPERIORITY||Difference in Proportion of Responders|0.03|||||TWO_SIDED|80.0|-0.05|0.11||||||Day 56||0.11|-0.05|
70934737|NCT01256359|141369868|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.318|TWO_SIDED|90.0|0.71|1.84|||Regression, Cox|||Analysis adjusted for with Mstatus and Performance Score||1.84|0.71|0.318
71024961|NCT02784106|141556938|SUPERIORITY||Difference in Proportion of Responders|-0.04|||||TWO_SIDED|80.0|-0.15|0.07||||||Day 84||0.07|-0.15|
71024962|NCT02784106|141556939|SUPERIORITY||Difference in Mean Changes|-1.4|||||TWO_SIDED|80.0|-5.37|2.58||||||||2.58|-5.37|
71024963|NCT02784106|141556940|SUPERIORITY||Difference in Mean Changes|-0.08|||||TWO_SIDED|80.0|-0.33|0.16||||||Day 28||0.16|-0.33|
71024964|NCT02784106|141556940|SUPERIORITY||Difference in Mean Changes|0.07|||||TWO_SIDED|80.0|-0.29|0.43||||||Day 84||0.43|-0.29|
71024965|NCT02784106|141556941|SUPERIORITY||Difference in Proportion of Participants|0.08|||||TWO_SIDED|80.0|-0.04|0.21||||||||0.21|-0.04|
71024966|NCT02784106|141556942|SUPERIORITY||Difference in Proportion of Participants|-0.04|||||TWO_SIDED|80.0|-0.13|0.06||||||||0.06|-0.13|
70934738|NCT01256359|141369906|SUPERIORITY||Hazard Ratio (HR)|1.022||||0.468|TWO_SIDED|90.0|0.649|1.612|||Regression, Cox||Analysis Adjusted for M status, performance status|This is a sensitivity analysis of the primary outcome.||1.612|0.649|0.468
70934739|NCT01256359|141369907|SUPERIORITY||Hazard Ratio (HR)|0.721||||0.106|TWO_SIDED|90.0|0.468|1.109|||Regression, Cox||Analysis was adjusted for mstatus, performance status|This is the per-protocol analysis of the primary outcome.||1.109|0.468|0.106
71024967|NCT00617461|141556975|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|-0.29||||0.013|TWO_SIDED|90.0|-0.48|-0.1|||ANCOVA|An ANCOVA (repeated measures mixed model) with body mass index, baseline 24-hr average pain intensity, and grouped center as covariates was used.||||-0.10|-0.48|0.013
71024968|NCT00358826|141556993|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.||||||<0.001
71024969|NCT00358826|141556993|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.||||||<0.001
71024970|NCT00358826|141556993|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.||||||<0.001
71024971|NCT00358826|141556994|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.||||||<0.001
71024972|NCT00358826|141556994|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.||||||<0.001
71024973|NCT00358826|141556994|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.||||||<0.001
71024974|NCT00358826|141556995|SUPERIORITY_OR_OTHER|||||||0.656||||||Adjusted using Dunnett's method.|ANCOVA|||||||0.656
71024975|NCT00358826|141556995|SUPERIORITY_OR_OTHER|||||||0.863||||||Adjusted using Dunnett's method.|ANCOVA|||||||0.863
71024976|NCT00358826|141556995|SUPERIORITY_OR_OTHER|||||||0.996||||||Adjusted using Dunnett's method.|ANCOVA|||||||0.996
71024977|NCT00358826|141556996|SUPERIORITY_OR_OTHER|||||||0.331||||||Adjusted using Dunnett's method.|ANCOVA|||||||0.331
71024978|NCT00358826|141556996|SUPERIORITY_OR_OTHER|||||||0.606||||||Adjusted using Dunnett's method.|ANCOVA|||||||0.606
71057758|NCT01272037|141620770|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.002|TWO_SIDED|95.0|0.43|0.83|||Regression, Cox||To compare the Chemo and Endocrine Therapy arm to the Endocrine Therapy Alone arm, a Cox model was used with adjustment for the continuous recurrence score.|This analysis includes only premenopausal participants.||0.83|0.43|0.002
71057759|NCT01272037|141620770|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.89|TWO_SIDED|95.0|0.82|1.26|||Regression, Cox||To compare the Chemo and Endocrine Therapy arm to the Endocrine Therapy Alone arm, a Cox model was used with adjustment for the continuous recurrence score.|This analysis includes only postmenopausal participants.||1.26|0.82|0.89
71057760|NCT01272037|141620777|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.009|TWO_SIDED|95.0|0.39|0.87|||Regression, Cox|||This analysis includes only premenopausal participants.|To compare DRFS between the Chemo and Endocrine Therapy arm and the Endocrine Therapy Alone arm, a Cox model was used with adjustment for the continuous recurrence score.|0.87|0.39|0.009
71057761|NCT01272037|141620777|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7|TWO_SIDED|95.0|0.81|1.37|||Regression, Cox||To compare DRFS between the Chemo and Endocrine Therapy arm and the Endocrine Therapy Alone arm, a Cox model was used with adjustment for the continuous recurrence score.|This analysis includes only postmenopausal participants.||1.37|0.81|0.70
71057762|NCT04152863|141620784|SUPERIORITY||Mean Difference (Net)|11.9||||0.1812|TWO_SIDED|90.0|-9.5|32.5|||Stratified Miettinen & Nurminen method|To ensure adequate number of participants, strata were combined according to sSAP when one treatment had 0 participants in a particular stratum.||||32.5|-9.5|0.1812
71057763|NCT04152863|141620784|SUPERIORITY||Mean Difference (Net)|4.8||||0.3548|TWO_SIDED|90.0|-16.2|25.5|||Stratified Miettinen & Nurminen method|To ensure adequate number of participants, strata were combined according to sSAP when one treatment had 0 participants in a particular stratum.||||25.5|-16.2|0.3548
71057764|NCT04152863|141620784|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in %|7.1|||||TWO_SIDED|90.0|-14.6|28.2||||||||28.2|-14.6|
71057765|NCT04152863|141620785|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.5|2.27||||||||2.27|0.50|
71057766|NCT04152863|141620785|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.51|2.29||||||||2.29|0.51|
71057767|NCT04152863|141620785|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.5|2.04||||||||2.04|0.50|
71057768|NCT04152863|141620787|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in percentage|-2.1|||||TWO_SIDED|90.0|-23.1|19.2||||||||19.2|-23.1|
71057769|NCT04152863|141620787|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in percentage|-2.1|||||TWO_SIDED|90.0|-23.1|19.2||||||||19.2|-23.1|
71057770|NCT04152863|141620787|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in %|0.0|||||TWO_SIDED|90.0|-21.2|21.2||||||||21.2|-21.2|
71057771|NCT04152863|141620788|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.45|||||TWO_SIDED|95.0|0.7|3.02||||||||3.02|0.70|
71108117|NCT02941614|141721630|OTHER||Rate Ratio|1.02||||0.919|TWO_SIDED|95.0|0.73|1.41|||Regression/Poisson|||||1.41|0.73|0.919
70934740|NCT01256359|141369908|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.824|TWO_SIDED|95.0|0.25|1.53||p-value is for the interaction term|Regression, Cox||HRs (95% CI) between treatment groups are given for Wild type and NRAS mutated separately. The above HR is for WT.|Model with interaction term between NRAS status and treatment group and stratification variables||1.53|0.25|0.824
70851756|NCT00244140|141191576|SUPERIORITY_OR_OTHER||Percent Images Rated Yes: BR2|100.0||||||95.0|99.0|100.0||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 2 (BR2).||100.0|99.0|
71024979|NCT00358826|141556996|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANOVA|||||||<0.001
71057772|NCT04152863|141620788|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.29|||||TWO_SIDED|95.0|0.62|2.68||||||||2.68|0.62|
70851757|NCT00244140|141191576|SUPERIORITY_OR_OTHER||Percent Images Rated Yes: BR3|99.7||||||95.0|98.6|100.0||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 3 (BR3).||100.0|98.6|
70934741|NCT01256359|141369909|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.072|TWO_SIDED|95.0|0.16|1.6||p-value is for interaction term.|Regression, Cox|Model includes interaction term between NRAS status and treatment group and stratification variables|"HRs for treatment effect (AZD6244 vs Placebo ) are estimated for NRAS WT and NRAS mutated patients separately.~Hazard ratios (95%CI) given above are for NRAS WT patients."|||1.60|0.16|0.072
70934742|NCT01256359|141369909|SUPERIORITY||Hazard Ratio (HR)|1.97|||||TWO_SIDED|95.0|0.73|5.33|||||HR for NRAS mutated patients|||5.33|0.73|
70934743|NCT01256359|141369911|SUPERIORITY|Adjusted for with Mstatus and Performance Score|Hazard Ratio (HR)|1.12||||0.348|TWO_SIDED|90.0|0.68|1.87|||Regression, Cox|||||1.87|0.68|0.348
70934744|NCT01256359|141369912|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.797|TWO_SIDED|90.0|0.24|1.58||p-value is for interaction term.|Regression, Cox|Model includes interaction term between NRAS status and treatment group and stratification variables|"HRs for treatment effect (AZD6244 vs Placebo ) are estimated for NRAS WT and NRAS mutated patients separately.~Hazard ratios (95%CI) given above are for NRAS WT patients."|||1.58|0.24|0.797
70934745|NCT01256359|141369912|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.35|1.45|||||HR for NRAS mutated patients|||1.45|0.350|
70934746|NCT01256359|141369913|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.12|TWO_SIDED|95.0|0.18|1.97||Model includes interaction term between NRAS status and treatment group and stratification variables. p-value is for interaction term.|Regression, Cox||"HRs for treatment effect (AZD6244 vs Placebo ) are estimated for NRAS WT and NRAS mutated patients separately.~Hazard ratios (95%CI) given above are for NRAS WT patients."|||1.97|0.18|0.120
70934747|NCT01256359|141369913|SUPERIORITY||Hazard Ratio (HR)|1.99|||||TWO_SIDED|95.0|0.73|5.38|||||HR for NRAS mutated patients|||5.38|0.73|
71024980|NCT00358826|141556997|SUPERIORITY_OR_OTHER|||||||0.22||||||Dunnett test compared with Placebo|ANCOVA|||||||0.22
71024981|NCT00358826|141556997|SUPERIORITY_OR_OTHER||||||<|0.005||||||Dunnett test compared with Placebo|ANCOVA|||||||<0.005
71024982|NCT00358826|141556997|SUPERIORITY_OR_OTHER|||||||0.6||||||Dunnett test compared with Placebo|ANCOVA|||||||0.60
71024983|NCT00358826|141556998|SUPERIORITY_OR_OTHER|||||||0.92||||||Dunnett test compared with Placebo|ANCOVA|||||||0.92
71024984|NCT00358826|141556998|SUPERIORITY_OR_OTHER|||||||0.96||||||Dunnett test compared with Placebo|ANCOVA|||||||0.96
71024985|NCT00358826|141556998|SUPERIORITY_OR_OTHER|||||||1||||||Dunnett test compared with Placebo|ANCOVA|||||||1.00
71024986|NCT00358826|141556999|SUPERIORITY_OR_OTHER|||||||0.99||||||Dunnett test compared with Placebo|ANCOVA|||||||0.99
70934748|NCT01429454|141369915|SUPERIORITY||Cox Proportional Hazard|0.36||||0.51|TWO_SIDED||||||Chi-squared|||||||.51
71024987|NCT00358826|141556999|SUPERIORITY_OR_OTHER|||||||0.11||||||Dunnett test compared with Placebo|ANCOVA|||||||0.11
71024988|NCT00358826|141556999|SUPERIORITY_OR_OTHER|||||||0.99||||||Dunnett test compared with Placebo|ANCOVA|||||||0.99
71024989|NCT00320593|141557019|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|||||TWO_SIDED|95.0|0.01|0.55|||ANCOVA|||The primary analysis was a comparison of treatment groups using an analysis of covariance (ANCOVA) model in which myopia at 3 years was adjusted for myopia at baseline and prior SVL wear. The sample size was computed to reach a 90% power and type I error rate of 5%, so that a difference in 3-year myopia progression between treatment groups would be detected if the true difference was at least 0.60 D, assuming a standard deviation of 0.85 D in each group and loss of follow up of 10%.||0.55|0.01|
71024990|NCT00320593|141557019|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27|||||TWO_SIDED|95.0|0.02|0.53|||ANCOVA|||An adjusted analysis for the treatment group difference of change in spherical equivalent from baseline to 3 years was performed by including in an analysis of covariance (ANCOVA) model the following covariates in addition to baseline myopia and prior single vision lens wear, which are known to be related to myopia progression: age, sex, ethnicity, accommodative lag, and magnitude of near esophoria.||0.53|0.02|
71024991|NCT00320593|141557022|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.14|||||TWO_SIDED|95.0|-0.005|0.28|||ANCOVA|||A secondary analysis was conducted to assess the treatment effect on myopia at the interim time point of 1 year, using an analysis of covariance (ANCOVA) model for the treatment group difference of change in spherical equivalent refractive error from baseline to 1 year, in which myopia at 1 year was adjusted for myopia at baseline and prior single vision lenses wear. Only complete cases (cases in which both baseline and 1 year values were known) were included.||0.28|-0.005|
71024992|NCT00320593|141557023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23|||||TWO_SIDED|95.0|0.02|0.45|||ANCOVA|||A secondary analysis was conducted to assess the treatment effect on myopia at the interim time point of 2 years, using an analysis of covariance (ANCOVA) model for the treatment group difference of change in spherical equivalent refractive error from baseline to 2 years, in which myopia at 2 years was adjusted for myopia at baseline and prior single vision lenses wear. Only complete cases (cases in which both baseline and 2 year values were known) were included.||0.45|0.02|
71024993|NCT00457665|141557025|SUPERIORITY|||||||0.94|||||||Mixed Models Analysis|||||||0.94
71024994|NCT01716754|141557026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.576|TWO_SIDED|95.0|0.35|1.78|||Regression, Logistic|||||1.78|0.35|0.576
71024995|NCT01716754|141557026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.556|TWO_SIDED|95.0|0.46|1.52|||Regression, Logistic|||||1.52|0.46|0.556
71108118|NCT02941614|141721631|OTHER||Rate Ratio|1.16||||0.367|TWO_SIDED|95.0|0.84|1.62|||Regression, Poisson|||The data below applies to Emergency Department visits||1.62|0.84|0.367
71108119|NCT02941614|141721631|OTHER||Rate Ratio|0.84||||0.497|TWO_SIDED|95.0|0.51|1.38|||Regression, Poisson|||The data below applies to Urgent Care visits||1.38|0.51|0.497
71108120|NCT01908140|141721658|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin=-0,055 L|Mean Difference (Final Values)|0.093|||<|0.001|TWO_SIDED|95.0|0.063|0.123|||MMRM|If non-inferiority on the PP was achieved then switch to superiority was tested on the ITT.||This sample size of 900 had 90% power to show that the lower bound of the two-sided 95% confidence interval for the difference between Aclidinium bromide 400 μg/Formoterol Fumarate 12 μg and SeretideTM AccuhalerTM (50/500 μg) in Peak FEV1 at 24 weeks is above -0,055 L||0.123|0.063|<0.001
71108121|NCT01908140|141721659|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority limit -0.5 units|Mean Difference (Final Values)|-0.001|||>|0.05|TWO_SIDED|95.0|-0.46|0.46|||MMRM|||The total sample size provided 81% nominal power to show that the lower bound of the two-sided 95 confidence interval for the difference between Aclidinium bromide 400 μg/Formoterol fumarate 12 μg and SeretideTM AccuhalerTM (50/500 μg) in transitional dyspnoea index (TDI) at 24 weeks is above -0,5||0.46|-0.46|>0.05
71108122|NCT01436110|141721660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037||||0.43|TWO_SIDED|95.0|-0.055|0.128|||ANCOVA|||||0.128|-0.055|0.430
71108123|NCT01436110|141721660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102||||0.03|TWO_SIDED|95.0|0.01|0.194|||ANCOVA|||||0.194|0.010|0.030
71108124|NCT01088503|141721673|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.7108|TWO_SIDED|95.0|0.88|1.22||Statistical analysis adjusted for the differences in baseline characteristics between participants treated with prasugrel vs. clopidogrel using propensity scoring.|Log Rank|||||1.22|0.88|0.7108
71108125|NCT01088503|141721674|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.464|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants with DES vs BMS.|||||
71108126|NCT01088503|141721674|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants with STEMI vs not STEMI|||||
71108127|NCT01088503|141721674|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.657|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants who were Other Race vs Caucasian.|||||
71108128|NCT01088503|141721674|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.684|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants who had cardiogenic shock within 24 hours vs no cardiogenic shock within 24 hours.|||||
70851758|NCT05408637|141191577|OTHER|The small sample size did not allow for statistical tests. Therefore, we looked at overall patterns and calculated differences between stimulation (Active vs Sham).|Mean Difference (Final Values)|54.75|||||TWO_SIDED||||||||Difference = Active - Sham|||||
70851759|NCT05408637|141191577|OTHER||Percent Difference|0.85|||||TWO_SIDED||||||||Difference = Active - Sham|The small sample size did not allow for statistical tests. Therefore, we looked at percent difference between stimulation (Active vs Sham).||||
71108129|NCT01088503|141721674|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.195|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants who were male vs not male.|||||
71108130|NCT01088503|141721674|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants with EQ-5D US index = 1 vs. \<1.|||||
71108131|NCT01088503|141721674|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.116|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants who were married vs not married.|||||
71108132|NCT01088503|141721674|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.125|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants who had diabetes vs no diabetes.|||||
71108133|NCT01088503|141721674|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.172|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants with no BMS or DES placement vs BMS.|||||
71108134|NCT01088503|141721675|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.1882|TWO_SIDED|95.0|0.88|1.93||Statistical analysis adjusted for the differences in baseline characteristics between participants treated with prasugrel vs. clopidogrel using propensity scoring.|Log Rank||Hazard ratio (HR) is for the analysis at 12 months.|||1.93|0.88|0.1882
71108135|NCT01088503|141721676|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.967|||||TWO_SIDED|95.0|0.849|1.103|||||Statistical analysis adjusted for the differences in baseline characteristics between participants treated with prasugrel vs. clopidogrel using propensity scoring.|||1.103|0.849|
71108136|NCT01088503|141721680|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants who had pre-procedure hemoglobin evaluation vs no hemoglobin evaluation.|||||
71108137|NCT01088503|141721681|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.005|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants with Duke CAD Index vs no Duke CAD Index.|||||
71108138|NCT00186628|141721689|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Log Rank|||||||.07
71108139|NCT01076010|141721705|OTHER||25% Quartile (months)|8.0|||||TWO_SIDED|95.0|4.4|12.9||||||||12.9|4.4|
71108140|NCT01076010|141721705|OTHER||50% Quartile (months)|15.2|||||TWO_SIDED|95.0|11.1||DR was only summarized for subjects who had an objective tumor response. Upper limit of confidence interval could not be determined.||||||||11.1|
71108141|NCT01076010|141721705|OTHER||25% Quartile (months)|12.9|||||TWO_SIDED|95.0|5.6||DR was only summarized for subjects who had an objective tumor response. Upper limit of confidence interval could not be determined.||||||||5.6|
71108142|NCT01076010|141721706|OTHER||25% Quartile (months)|3.6|||||TWO_SIDED|95.0|1.9|5.2||||||||5.2|1.9|
71108143|NCT01076010|141721706|OTHER||50% Quartile (months)|11.0|||||TWO_SIDED|95.0|7.3|12.7||||||||12.7|7.3|
71108144|NCT01076010|141721706|OTHER||75% Quartile (months)|20.9|||||TWO_SIDED|95.0|16.5||For the subjects in each treatment arm, PFS is calculated from the first dose date of the respective study drugs. Upper limit of confidence interval could not be determined.||||||||16.5|
71108145|NCT01076010|141721706|OTHER||25% Quartile (months)|7.2|||||TWO_SIDED|95.0|3.5|9.2||||||||9.2|3.5|
71024996|NCT01716754|141557028|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.483|TWO_SIDED|95.0|0.61|2.86|||Regression, Logistic|||||2.86|0.61|0.483
71024997|NCT01716754|141557028|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.261|TWO_SIDED|95.0|0.79|2.44|||Regression, Logistic|||||2.44|0.79|0.261
71024998|NCT01716754|141557030|SUPERIORITY_OR_OTHER|||||||0.604|||||||Repeated measures mixed model|||Morning||||0.604
71024999|NCT01716754|141557030|SUPERIORITY_OR_OTHER|||||||0.26|||||||Repeated measures mixed model|||Morning||||0.260
71025000|NCT01716754|141557030|SUPERIORITY_OR_OTHER|||||||0.937|||||||Repeated measures mixed model|||Evening||||0.937
71025001|NCT01716754|141557030|SUPERIORITY_OR_OTHER|||||||0.88|||||||Repeated measures mixed model|||Evening||||0.880
71025002|NCT01716754|141557030|SUPERIORITY_OR_OTHER|||||||0.762|||||||Repeated measures mixed model|||Overall daily||||0.762
71025003|NCT01716754|141557030|SUPERIORITY_OR_OTHER|||||||0.408|||||||Repeated measures mixed model|||Overall daily||||0.408
71025004|NCT01851590|141557068|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Proportions and 95% confidence intervals (CIs) were calculated for negative KOH staining, negative cultures, and a combination of these at 4- and 10-month time points. Cochran-Mantel-Haenszel and χ2-tests were used to analyse efficacy criteria.|Cochran-Mantel-Haenszel|||The sample size was estimated according to complete mycological cure at 10 months. Estimation was based on the design of a binary-outcome head-to-head superiority trial. Orally administered terbinafine treatment was considered the active control. Approximately 25 patients / arm were required to have 80% power (β=0.2) at a two-sided α=0.05 significance level to detect a decrease in primary outcome from 50% in the terbinafine arm to 15% in the amorolfine or resin lacquer treatment arms.||||<0.05
71057773|NCT04152863|141620788|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.6|2.22||||||||2.22|0.60|
71057774|NCT04152863|141620790|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.64|||||TWO_SIDED|95.0|0.71|3.79||||||||3.79|0.71|
71057775|NCT04152863|141620790|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.47|2.68||||||||2.68|0.47|
71057776|NCT04152863|141620790|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.39|||||TWO_SIDED|95.0|0.64|3.02||||||||3.02|0.64|
71057777|NCT01297985|141620793|SUPERIORITY||MIXREG Estimate|1.55|STANDARD_ERROR_OF_MEAN|0.62||0.013|TWO_SIDED||||||Mixed Effects Random Regression|||"This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in self-perceived Recovery and that this effect would be maintained overtime; and that intervention participants would report greater increases in hopefulness than controls, also maintained longitudinally~This first model reports on Recovery over time."||||.013
71077942|NCT02913105|141664399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.04||||0.5246|TWO_SIDED|90.0|0.94|1.15|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 56||1.15|0.94|0.5246
71025005|NCT01851590|141557069|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Differences between quantitative data were assessed with one-way analysis of variances, and pairwise comparisons were performed with Bonferroni's post hoc test.|ANOVA|||||||<0.05
71025006|NCT01851590|141557070|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Differences between quantitative data were assessed with one-way analysis of variances, and pairwise comparisons were performed with Bonferroni's post hoc test.|ANOVA|||||||<0.05
71025007|NCT01851590|141557071|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Differences between quantitative data were assessed with one-way analysis of variances, and pairwise comparisons were performed with Bonferroni's post hoc test.|ANOVA|||||||<0.05
71025008|NCT01851590|141557072|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Qualitative data are expressed as frequencies and percentages, and differences between parallel groups were compared with the χ2-test or Fisher's exact test, as appropriate.|Chi-squared|||||||<0.05
71025009|NCT01714505|141557075|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 1 sided|Paired t-tests: compare LBGI, carbohydrates for hypoglycemia treatment, % of time in range and average BG on CLC vs OL.||||||0.003
71025010|NCT01714505|141557076|SUPERIORITY_OR_OTHER||||||>|0.1|||||||t-test, 1 sided|||||||>0.1
71025011|NCT01714505|141557077|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
71025012|NCT00321711|141557102|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.032||||||95.0|0.153|6.95||||||||6.950|0.153|
71025013|NCT00321711|141557102|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.333||||||95.0|0.028|3.926||||||||3.926|0.028|
71025014|NCT00321711|141557102|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.118||||||95.0|0.007|1.882|||||Adjusted by the stratification factor|||1.882|0.007|
71025015|NCT00321711|141557103|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||||95.0|0.063|15.988|||||Romiplostim/placebo|||15.988|0.063|
71025016|NCT00321711|141557104|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.827||||||95.0|0.347|9.618|||||Romiplostim/placebo|||9.618|0.347|
71025017|NCT00321711|141557104|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.445||||||95.0|0.037|5.325|||||Romiplostim/placebo|||5.325|0.037|
71025018|NCT00321711|141557104|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.444||||||95.0|0.032|6.08|||||Romiplostim/placebo|||6.080|0.032|
71025019|NCT00321711|141557105|SUPERIORITY_OR_OTHER||Difference in incidence rate|-33.5||||||95.0|-69.0|2.0|||||Romiplostim - placebo|||2.0|-69.0|
71025020|NCT00321711|141557105|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.315||||||95.0|0.029|3.412||||||||3.412|0.029|
71025021|NCT00321711|141557105|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.211||||||95.0|0.021|2.082||||||||2.082|0.021|
71025022|NCT01832090|141557114|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71025023|NCT01832090|141557115|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71025024|NCT01832090|141557116|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71025025|NCT01832090|141557117|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71025026|NCT01832090|141557118|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||||||>0.05
71025027|NCT01832090|141557119|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||||||>0.05
71025028|NCT01832090|141557122|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71025029|NCT01832090|141557123|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71025030|NCT01211769|141557127|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||TIME COMPARISON||||<0.001
71025031|NCT01211769|141557127|SUPERIORITY_OR_OTHER||Variance (F)|0.71||||0.69||95.0|||||ANOVA|||GROUP COMPARISON||||0.69
71057778|NCT01297985|141620794|SUPERIORITY||MIXREG Estimate|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.01|TWO_SIDED||||||Mixed Effects Random Regression|This analysis used Random Regression Modeling; this first model included depressive symptoms as moderator||"We tested 3 moderating variables: BSI depressive symptom, anxiety, and general symptom distress. In these three models, we hypothesized that the intervention participants with high levels of each type of symptoms would experience greater gains in empowerment over time than participants with low levels of symptoms, as well as control participants with both high and low symptom level.~This model includes depressive symptoms as the moderator (High depressive symptoms X time X study condition)"||||0.01
71057779|NCT01297985|141620794|SUPERIORITY||MIXREG Estimate|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.01|TWO_SIDED||||||Mixed Effects Random Regression|This analysis used Random Regression Modeling; this second model included anxiety symptoms as moderator||"We tested 3 moderating variables: depressive symptom, anxiety, and general symptom distress. In these three models, we hypothesized that the intervention participants with high levels of each type of symptoms would experience greater gains in empowerment over time than participants with low levels of symptoms, as well as control participants with both high and low symptom level.~This model includes anxiety as the moderator (high anxiety X time X study condition)"||||0.01
71108146|NCT01076010|141721707|OTHER||25% Quartile (months)|8.2|||||TWO_SIDED|95.0|6.0|12.1||||||||12.1|6.0|
70851760|NCT05408637|141191577|OTHER||Cohen's d|0.07|||||TWO_SIDED|||||||||We evaluated the effect size of the difference between Active and Sham using Cohen's d.||||
70851761|NCT05408637|141191578|OTHER|The small sample size did not allow for statistical tests. Therefore, we looked at overall patterns and calculated differences between active stimulation timepoints (Day 1 vs Day 5).|Mean Difference (Final Values)|224.8392|||||TWO_SIDED||||||||Difference = Day 5 Active - Day 1 Active|||||
70934749|NCT01429454|141369916|SUPERIORITY||||||>|0.1|||||||Mixed Models Analysis|||||||>0.10
70934750|NCT02000752|141369917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.98|||<|0.001|ONE_SIDED|95.0|7.59||||t-test, 1 sided||||||7.59|<0.001
71025032|NCT01211769|141557128|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||TIME COMPARISON||||<0.001
71025033|NCT01211769|141557128|SUPERIORITY_OR_OTHER||Variance (F)|0.73||||0.53||95.0|||||ANOVA|||GROUP COMPARISON||||0.53
71025034|NCT01211769|141557129|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||TIME COMPARISON||||<0.001
71025035|NCT01211769|141557129|SUPERIORITY_OR_OTHER||Variance (F)|1.08||||0.37||95.0|||||ANOVA|||GROUP COMPARISON||||0.37
71025036|NCT01484028|141557144|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.05 LogMAR was used.|Least-square mean difference|0.011|STANDARD_ERROR_OF_MEAN|0.0034|||TWO_SIDED|95.0|0.004|0.017|||Mixed Models Analysis|||The alternative hypothesis is the monocular distance Snellen VA (LogMAR scale) of etafilcon A with embedded print and PVP for dark/light eyes is non-inferior to that of etafilcon A control lenses.||0.017|0.004|
71025037|NCT01199601|141557155|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.12|STANDARD_DEVIATION|0.05|<|0.05|TWO_SIDED|95.0|1.02|1.23|||Regression, Linear|Information provided for crude analysis results; adjustment for significant baseline differences between groups did not change results substantially.||Outcomes were assessed by crude and adjusted risk ratios with log-binomial generalized linear models.||1.23|1.02|<0.05
71025038|NCT01199601|141557156|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.1|STANDARD_DEVIATION|0.05|<|0.05|TWO_SIDED|95.0|1.02|1.18|||Regression, Linear|Outcomes were assessed by crude and adjusted risk ratios with log-binomial generalized linear models.||||1.18|1.02|<0.05
71025039|NCT01199601|141557157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13|STANDARD_DEVIATION|0.05||0.05|TWO_SIDED|95.0|1.01|1.25|||Regression, Logistic|The crude analysis result is provided as the odds ratio did not change substantially when adjusted for possible confounders.||||1.25|1.01|0.05
71025040|NCT01149616|141557188|SUPERIORITY|||||||0.007|||||||ANOVA|||||||0.007
71025041|NCT01149616|141557189|SUPERIORITY|||||||0.006|||||||ANOVA|||||||0.006
71025042|NCT01149616|141557190|SUPERIORITY|||||||0.05||||||P value was calculated, and threshold for significance calculated at less than or equal to 0.05|ANOVA|||||||0.05
71025043|NCT01688037|141557230|OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.8||0.2966|TWO_SIDED|95.0|-2.3|0.7|||ANCOVA|||||0.7|-2.3|0.2966
71025044|NCT01688037|141557231|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.743|TWO_SIDED|95.0|-0.3|0.4|||ANOVA|||||0.4|-0.3|0.743
71025045|NCT01688037|141557232|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1151|TWO_SIDED|95.0|-0.7|0.1|||ANOVA|||||0.1|-0.7|0.1151
71025046|NCT01688037|141557232|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0277|TWO_SIDED|95.0|-0.8|0.0|||ANOVA|||||0.0|-0.8|0.0277
71025047|NCT03280537|141557236|SUPERIORITY||Difference in Least Squares Means|-0.59|STANDARD_ERROR_OF_MEAN|0.23||0.014|TWO_SIDED|95.0|-1.05|-0.12||Tested at the two-sided 0.05 significance level. There was no adjustment for multiplicity for the co-primary outcome measures.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NPS, treatment and baseline NPS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The primary analysis tested the null hypothesis that no treatment group difference existed for change from baseline in NPS at Week 24. As NPS and NCS are co-primary outcome measures, both null hypotheses for NPS and NCS must be rejected, with parameter estimates indicating a benefit of omalizumab over placebo, for the study to be deemed positive.||-0.12|-1.05|0.0140
70851762|NCT05408637|141191578|OTHER||Percent Difference|4.35|||||TWO_SIDED||||||||Difference = Day 5 Active - Day 1 Active|The small sample size did not allow for statistical tests. Therefore, we calculated percent difference between active stimulation timepoints (Day 1 vs Day 5).||||
70934751|NCT02000752|141369918|SUPERIORITY_OR_OTHER||difference in percentage|0.0||||1|TWO_SIDED|95.0|||||t-test, 2 sided|||||||1
70934752|NCT02000752|141369919|SUPERIORITY_OR_OTHER||difference in percentages|2.13||||0.16|ONE_SIDED|95.0|1.01||||t-test, 1 sided||||||1.01|0.16
70934753|NCT02000752|141369920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.84||||0.2|ONE_SIDED|95.0|0.84||||t-test, 2 sided||||||0.84|0.2
71057780|NCT01297985|141620794|SUPERIORITY||MIXREG Estimate|0.03|STANDARD_ERROR_OF_MEAN|0.01||0.022|TWO_SIDED||||||Mixed Effects Random Regression|This analysis used Random Regression Modeling; this third model included the general symptom distress as moderator||"We tested 3 moderating variables: BSI depressive symptom, anxiety, and general symptom distress. In these three models, we hypothesized that the intervention participants with high levels of each type of symptoms would experience greater gains in empowerment over time than participants with low levels of symptoms, as well as control participants with both high and low symptom level.~This model includes general symptom distress as the moderator (high symptom distress X time X study condition)"||||.022
71057781|NCT01297985|141620795|SUPERIORITY||MIXREG Estimate|0.33|STANDARD_ERROR_OF_MEAN|0.012|<|0.01|TWO_SIDED||||||Mixed Effects Random Regression|||This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in Hopefulness that would be maintained longitudinally||||<.01
71057782|NCT01297985|141620796|SUPERIORITY||MIXREG Estimate|0.12|STANDARD_ERROR_OF_MEAN|0.04|<|0.01|TWO_SIDED||||||Mixed Effects Random Regression|||This analysis Mixed Effects Random Regression Modeling to test whether self-advocacy scores changed overtime by study condition status. Reported below are findings for the self-advocacy assertiveness sub scale.||||<0.01
71057783|NCT01297985|141620797|SUPERIORITY||MIXREG Estimate|0.042|STANDARD_ERROR_OF_MEAN|0.018||0.017|TWO_SIDED||||||Mixed Effects Random Regression|||||||0.017
71057784|NCT05044195|141620830|NON_INFERIORITY|Non-inferiority criteria for the GMT ratio: upper limit (UL) of the 95% confidence interval (CI) for the inter-group GMT ratio is ≤1.5 for each vaccine strain|GMT ratio|0.802|||||TWO_SIDED|95.0|0.738|0.871||||||A/H1N1||0.871|0.738|
70934754|NCT04938453|141369926|OTHER||Ratio of GLSMs (%)|98.47|STANDARD_ERROR_OF_MEAN|13.9|||TWO_SIDED|90.0|90.87|106.69|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of nintedanib 4 X 25 mg)/(GLSM of nintedanib 1 X 100 mg).~Standard error of the mean is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis of this primary endpoint was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||106.69|90.87|
71057785|NCT05044195|141620830|NON_INFERIORITY|Non-inferiority criteria for the GMT ratio: UL of the 95% CI for the inter-group GMT ratio is ≤1.5 for each vaccine strain|GMT ratio|0.9|||||TWO_SIDED|95.0|0.819|0.989||||||A/H3N2||0.989|0.819|
71057786|NCT05044195|141620830|NON_INFERIORITY|Non-inferiority criteria for the GMT ratio: UL of the 95% CI for the inter-group GMT ratio is ≤1.5 for each vaccine strain|GMT ratio|0.944|||||TWO_SIDED|95.0|0.88|1.012||||||B/Yamagata||1.012|0.880|
71108147|NCT01076010|141721707|OTHER||50% Quartile (months)|21.6|||||TWO_SIDED|95.0|17.0|27.6||||||||27.6|17.0|
70851763|NCT05408637|141191578|OTHER||Cohen's d|0.36|||||TWO_SIDED|||||||||We evaluated the effect size of the difference between active stimulation timepoints (Day 1 vs Day 5) using Cohen's d.||||
70934755|NCT04938453|141369927|OTHER||Ratio of GLSMs (%)|100.29|STANDARD_ERROR_OF_MEAN|29.2|||TWO_SIDED|90.0|85.05|118.24|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of nintedanib 4 X 25 mg)/(GLSM of nintedanib 1 X 100 mg).~Standard error of the mean is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis of this primary endpoint was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||118.24|85.05|
70934756|NCT04938453|141369928|OTHER||Ratio of GLSMs (%)|98.92|STANDARD_ERROR_OF_MEAN|13.8|||TWO_SIDED|90.0|91.35|107.12|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of nintedanib 4 X 25 mg)/(GLSM of nintedanib 1 X 100 mg).~Standard error of the mean is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis of this primary endpoint was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||107.12|91.35|
71057787|NCT05044195|141620830|NON_INFERIORITY|Non-inferiority criteria for the GMT ratio: UL of the 95% CI for the inter-group GMT ratio is ≤1.5 for each vaccine strain|GMT ratio|0.992|||||TWO_SIDED|95.0|0.923|1.067||||||B/Victoria||1.067|0.923|
71057788|NCT05044195|141620831|NON_INFERIORITY|Non-inferiority criteria for the SCR difference: UL of the 95% CI for the difference in SCR is ≤10% for each vaccine strain|SCR difference|-4.4|||||TWO_SIDED|95.0|-7.97|-0.74||||||A/H1N1||-0.74|-7.97|
71057789|NCT05044195|141620831|NON_INFERIORITY|Non-inferiority criteria for the SCR difference: UL of the 95% CI for the difference in SCR is ≤10% for each vaccine strain|SCR difference|-1.8|||||TWO_SIDED|95.0|-6.14|2.48||||||A/H3N2||2.48|-6.14|
71057790|NCT05044195|141620831|NON_INFERIORITY|Non-inferiority criteria for the SCR difference: UL of the 95% CI for the difference in SCR is ≤10% for each vaccine strain|SCR difference|-2.4|||||TWO_SIDED|95.0|-6.77|2.0||||||B/Yamagata||2.00|-6.77|
71057791|NCT05044195|141620831|NON_INFERIORITY|Non-inferiority criteria for the SCR difference: UL of the 95% CI for the difference in SCR is ≤10% for each vaccine strain|SCR difference|-3.9|||||TWO_SIDED|95.0|-8.31|0.45||||||B/Victoria||0.45|-8.31|
71057792|NCT05044195|141620832|SUPERIORITY||GMT ratio|0.808|||||TWO_SIDED|95.0|0.745|0.876||||||A/H1N1||0.876|0.745|
71108148|NCT01076010|141721707|OTHER||75% Quartile (months)|30.7|||||TWO_SIDED|95.0|28.8||For the subjects in each treatment arm, OS is calculated from the first dose date of the respective study drugs. Upper limit of confidence interval could not be determined.||||||||28.8|
70934757|NCT00273052|141369929|SUPERIORITY_OR_OTHER||Median Difference (Net)|-8.026||||0.0141||95.0|-15.35|-0.67|||ANCOVA||Median difference = Coreg CR - Toprol XL|||-0.67|-15.35|0.0141
70934758|NCT00273052|141369930|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7||||0.6068||95.0|-2.4|3.9|||ANCOVA||Mean difference = Coreg CR - Toprol XL|||3.9|-2.4|0.6068
71057793|NCT05044195|141620832|SUPERIORITY||GMT ratio|0.91|||||TWO_SIDED|95.0|0.829|0.998||||||A/H3N2||0.998|0.829|
71057794|NCT05044195|141620832|SUPERIORITY||GMT ratio|0.947|||||TWO_SIDED|95.0|0.884|1.014||||||B/Yamagata||1.014|0.884|
71057795|NCT05044195|141620832|SUPERIORITY||GMT ratio|1.0|||||TWO_SIDED|95.0|0.931|1.075||||||B/Victoria||1.075|0.931|
71057796|NCT05044195|141620833|OTHER||GMT ratio|0.87|||||TWO_SIDED|95.0|0.803|0.944||||||A/H1N1||0.944|0.803|
71057797|NCT05044195|141620833|OTHER||GMT ratio|0.953|||||TWO_SIDED|95.0|0.88|1.032||||||A/H3N2||1.032|0.880|
71057798|NCT05044195|141620833|OTHER||GMT ratio|1.013|||||TWO_SIDED|95.0|0.953|1.077||||||B/Yamagata||1.077|0.953|
71057799|NCT05044195|141620833|OTHER||GMT ratio|1.028|||||TWO_SIDED|95.0|0.963|1.098||||||B/Victoria||1.098|0.963|
71057800|NCT05044195|141620841|OTHER||GMT ratio|0.838|||||TWO_SIDED|95.0|0.751|0.936||||||A/H1N1 (50 to 59 years)||0.936|0.751|
71057801|NCT05044195|141620841|OTHER||GMT ratio|0.924|||||TWO_SIDED|95.0|0.821|1.04||||||A/H3N2 (50 to 59 years)||1.040|0.821|
71057802|NCT05044195|141620841|OTHER||GMT ratio|0.926|||||TWO_SIDED|95.0|0.845|1.015||||||B/Yamagata (50 to 59 years)||1.015|0.845|
71057803|NCT05044195|141620841|OTHER||GMT ratio|0.989|||||TWO_SIDED|95.0|0.901|1.087||||||B/Victoria (50 to 59 years)||1.087|0.901|
71057804|NCT05044195|141620841|OTHER||GMT ratio|0.767|||||TWO_SIDED|95.0|0.681|0.864||||||A/H1N1 (60 to 64 years)||0.864|0.681|
71057805|NCT05044195|141620841|OTHER||GMT ratio|0.89|||||TWO_SIDED|95.0|0.766|1.033||||||A/H3N2 (60 to 64 years)||1.033|0.766|
70934759|NCT03345979|141369959|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
70934760|NCT03345979|141369959|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
70934761|NCT00670488|141369987|OTHER||AUC0-48hr GMR|3.26||||||||||||||"The Last Day (Day 27)/Day 1 AUC 0-48 hr Geometric Mean Ratio (GMR) was calculated as follows: Last Day (Day 27) AUC 0-48hr Geometric Mean (GM) ÷ Day 1 AUC 0-48hr GM.~AUC 0-48hr GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."||||
71057806|NCT05044195|141620841|OTHER||GMT ratio|0.974|||||TWO_SIDED|95.0|0.879|1.079||||||B/Yamagata (60 to 64 years)||1.079|0.879|
71057807|NCT05044195|141620841|OTHER||GMT ratio|1.013|||||TWO_SIDED|95.0|0.905|1.133||||||B/Victoria (60 to 64 years)||1.133|0.905|
71057808|NCT05044195|141620842|OTHER||GMT ratio|0.844|||||TWO_SIDED|95.0|0.761|0.935||||||A/H1N1 (yes)||0.935|0.761|
71057809|NCT05044195|141620842|OTHER||GMT ratio|1.01|||||TWO_SIDED|95.0|0.904|1.128||||||A/H3N2 (yes)||1.128|0.904|
71057810|NCT05044195|141620842|OTHER||GMT ratio|0.948|||||TWO_SIDED|95.0|0.883|1.016||||||B/Yamagata (yes)||1.016|0.883|
71057811|NCT05044195|141620842|OTHER||GMT ratio|0.997|||||TWO_SIDED|95.0|0.926|1.073||||||B/Victoria (yes)||1.073|0.926|
71057812|NCT05044195|141620842|OTHER||GMT ratio|0.772|||||TWO_SIDED|95.0|0.677|0.88||||||A/H1N1 (no)||0.880|0.677|
71057813|NCT05044195|141620842|OTHER||GMT ratio|0.801|||||TWO_SIDED|95.0|0.683|0.941||||||A/H3N2 (no)||0.941|0.683|
70934762|NCT00670488|141369987|OTHER||AUC 0-48hr GMR|3.18||||||||||||||"The Last Day (Day 27)/Day 1 AUC 0-48 hr GMR was calculated as follows: Last Day (Day 27) AUC 0-48hr GM ÷ Day 1 AUC 0-48hr GM.~AUC 0-48hr GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."||||
71057814|NCT05044195|141620842|OTHER||GMT ratio|0.945|||||TWO_SIDED|95.0|0.831|1.076||||||B/Yamagata (no)||1.076|0.831|
71057815|NCT05044195|141620842|OTHER||GMT ratio|1.007|||||TWO_SIDED|95.0|0.881|1.151||||||B/Victoria (no)||1.151|0.881|
71057816|NCT05044195|141620843|OTHER||GMT ratio|0.82|||||TWO_SIDED|95.0|0.752|0.894||||||A/H1N1 (Comorbidity Risk Score \<50)||0.894|0.752|
71057817|NCT05044195|141620843|OTHER||GMT ratio|0.933|||||TWO_SIDED|95.0|0.846|1.029||||||A/H3N2 (Comorbidity Risk Score \<50)||1.029|0.846|
71057818|NCT05044195|141620843|OTHER||GMTratio|0.972|||||TWO_SIDED|95.0|0.904|1.046||||||B/Yamagata (Comorbidity Risk Score \<50)||1.046|0.904|
71057819|NCT05044195|141620843|OTHER||GMT ratio|1.013|||||TWO_SIDED|95.0|0.938|1.094||||||B/Victoria (Comorbidity Risk Score \<50)||1.094|0.938|
71057820|NCT05044195|141620843|OTHER||GMT ratio|0.706|||||TWO_SIDED|95.0|0.553|0.902||||||A/H1N1 (Comorbidity Risk Score ≥50)||0.902|0.553|
71057821|NCT05044195|141620843|OTHER||GMT ratio|0.734|||||TWO_SIDED|95.0|0.549|0.982||||||A/H3N2 (Comorbidity Risk Score ≥50)||0.982|0.549|
71057822|NCT05044195|141620843|OTHER||GMT ratio|0.773|||||TWO_SIDED|95.0|0.638|0.935||||||B/Yamagata (Comorbidity Risk Score ≥50)||0.935|0.638|
71057823|NCT05044195|141620843|OTHER||GMT ratio|0.905|||||TWO_SIDED|95.0|0.739|1.107||||||B/Victoria (Comorbidity Risk Score ≥50)||1.107|0.739|
71057824|NCT02585778|141620854|SUPERIORITY||LS Mean Difference|-47.8|||<|0.0001|TWO_SIDED|95.0|-60.7|-35.0||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-35.0|-60.7|<0.0001
71057825|NCT02585778|141620854|SUPERIORITY||LS Mean Difference|-49.0|||<|0.0001|TWO_SIDED|95.0|-54.4|-43.6||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-43.6|-54.4|<0.0001
71057826|NCT02585778|141620856|SUPERIORITY||LS Mean Difference|-50.6|||<|0.0001|TWO_SIDED|95.0|-63.4|-37.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level. Hierarchical testing procedure was followed for T1DM and T2DM participants separately.||-37.9|-63.4|<0.0001
71057827|NCT02585778|141620856|SUPERIORITY||LS Mean Difference|-51.6|||<|0.0001|TWO_SIDED|95.0|-56.9|-46.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-46.4|-56.9|<0.0001
71057828|NCT02585778|141620857|SUPERIORITY||LS Mean Difference|-48.4|||<|0.0001|TWO_SIDED|95.0|-61.2|-35.5||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-35.5|-61.2|<0.0001
70851764|NCT05408637|141191579|OTHER||rank biserial correlation coefficient|0.767||||0.15|TWO_SIDED||||||Wilcoxon signed rank test|||The Wilcoxon signed-rank test was used to evaluate changes in the IGT at Baseline vs Day 5 due to the small sample size and distributional assumptions. Effect sizes were calculated using the rank biserial correlation coefficient (r) to estimate the magnitude of change.||||0.15
71057829|NCT02585778|141620857|SUPERIORITY||LS Mean Difference|-45.7|||<|0.0001|TWO_SIDED|95.0|-50.9|-40.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-40.4|-50.9|<0.0001
71057830|NCT02585778|141620858|SUPERIORITY||LS Mean Difference|-44.8|||<|0.0001|TWO_SIDED|95.0|-56.9|-32.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-32.8|-56.9|<0.0001
71057831|NCT02585778|141620858|SUPERIORITY||LS Mean Difference|-50.2|||<|0.0001|TWO_SIDED|95.0|-55.2|-45.3||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-45.3|-55.2|<0.0001
71057832|NCT02585778|141620859|SUPERIORITY||LS Mean Difference|-42.7|||<|0.0001|TWO_SIDED|95.0|-54.9|-30.5||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-30.5|-54.9|<0.0001
71057833|NCT02585778|141620859|SUPERIORITY||LS Mean Difference|-44.1|||<|0.0001|TWO_SIDED|95.0|-49.0|-39.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-39.2|-49.0|<0.0001
71057834|NCT02585778|141620860|SUPERIORITY||LS Mean Difference|-42.7|||<|0.0001|TWO_SIDED|95.0|-54.2|-31.3||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-31.3|-54.2|<0.0001
71057835|NCT02585778|141620860|SUPERIORITY||LS Mean Difference|-38.7|||<|0.0001|TWO_SIDED|95.0|-43.4|-33.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-33.9|-43.4|<0.0001
71057836|NCT02585778|141620861|SUPERIORITY||LS Mean Difference|-39.0|||<|0.0001|TWO_SIDED|95.0|-49.4|-28.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-28.7|-49.4|<0.0001
71057837|NCT02585778|141620861|SUPERIORITY||LS Mean Difference|-36.7|||<|0.0001|TWO_SIDED|95.0|-40.9|-32.5||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-32.5|-40.9|<0.0001
71057838|NCT02585778|141620862|SUPERIORITY||LS Mean Difference|-29.2|||<|0.0001|TWO_SIDED|95.0|-37.8|-20.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-20.7|-37.8|<0.0001
71057839|NCT02585778|141620862|SUPERIORITY||LS Mean Difference|-27.6|||<|0.0001|TWO_SIDED|95.0|-31.2|-24.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-24.1|-31.2|<0.0001
71057840|NCT02585778|141620863|SUPERIORITY||Odds Ratio (OR)|117.0|||<|0.0001|TWO_SIDED|95.0|13.1|1041.8||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||1041.8|13.1|<0.0001
71057841|NCT02585778|141620863|SUPERIORITY||Odds Ratio (OR)|84.6|||<|0.0001|TWO_SIDED|95.0|36.5|196.1||Threshold for significance at 0.05 level|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||196.1|36.5|<0.0001
71057842|NCT02585778|141620864|SUPERIORITY||Odds Ratio (OR)|52.9|||<|0.0001|TWO_SIDED|95.0|16.6|168.3||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||168.3|16.6|<0.0001
71057843|NCT02585778|141620865|SUPERIORITY||Odds Ratio (OR)|33.2|||<|0.0001|TWO_SIDED|95.0|8.0|137.4||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||137.4|8.0|<0.0001
71057844|NCT02585778|141620865|SUPERIORITY||Odds Ratio (OR)|27.1|||<|0.0001|TWO_SIDED|95.0|14.2|51.5||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||51.5|14.2|<0.0001
71057845|NCT02585778|141620866|SUPERIORITY||Odds Ratio (OR)|55.5||||0.0002|TWO_SIDED|95.0|6.5|473.7||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||473.7|6.5|0.0002
70934763|NCT00670488|141369988|OTHER||Cmax GMR|2.59||||||||||||||"The Last Day (Day 27)/Day 1 Cmax GMR was calculated as follows: Last Day (Day 27) Cmax GM ÷ Day 1 Cmax GM.~Cmax GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."||||
70851765|NCT05408637|141191579|OTHER|The Friedman test was used to assess overall differences in IGT across Baseline, Day 1, and Day 5.||||||0.038|||||||Friedman test|||||||0.038
70851766|NCT05408637|141191579|OTHER|The Friedman test was used to assess overall differences in IGT across all timepoints (Baseline, Day 1, Day 5, Follow-Up).||||||0.043|||||||Friedman test|||||||0.043
71108149|NCT03767881|141721716|NON_INFERIORITY|The upper limit of a 97.8% confidence limit of the mean days to resolution of acute cholecystitis is compared to a Performance Goal of 3.5 days.|Mean Difference (Final Values)|3.5|||||ONE_SIDED|97.8||10.78|||t-test, 1 sided|||||10.78||
71108150|NCT03767881|141721717|NON_INFERIORITY|The upper limit of a 99.7% confidence limit of the proportion of patients with reintervention, including migration and occlusion, is compared to a Performance Goal of 46.2%.|Performance Goal|16.7|||||ONE_SIDED|99.7||42.0|||1-sided Clopper-Pearson 99.7% CI|||||42.0||
71108151|NCT03498716|141721746|SUPERIORITY|Stratified Analysis: The stratification factors used in the analysis are axillary nodal status, surgery (breast conserving vs. mastectomy),and tumor PD-L1 status.|Hazard Ratio (HR)|1.11||||0.3846|TWO_SIDED|95.0|0.87|1.42|||Log Rank|||||1.42|0.87|0.3846
71108152|NCT00265850|141721760|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.08|TWO_SIDED|95.0|0.77|1.01|||Log Rank|||||1.01|0.77|0.08
71108153|NCT00265850|141721761|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.45|TWO_SIDED|95.0|0.84|1.08|||Log Rank|||||1.08|0.84|0.45
71108154|NCT02797821|141721768|OTHER||Least Squares (LS) Means Difference|-1.88|||<|0.0001|TWO_SIDED|95.0|-2.544|-1.216||REML-based repeated measures mixed model (treatment, visit, sex, Baseline PPi, Baseline weight group \[≥median vs \< median\], and study drug lot assignment as factors) with an unstructured covariance structure for within-participant correlation.|REML|A fixed sequence testing procedure was used to control the Type I error rate. A statistical adjustment of p-values was not performed.||A fixed sequence testing procedure was performed to compare the 3.0 mg/kg cohort with the 0.5 mg/kg cohort first. The hypothesis testing for the second comparison of the 2.0 mg/kg cohort compared with the 0.5 mg/kg cohort was only performed if the null hypothesis was rejected for the previous comparison at a significance level of 0.05 (p-value \<0.05). The primary endpoint was met if the null hypothesis was rejected for both comparisons at a significance level of 0.05 (both p-values \<0.05).||-1.216|-2.544|<0.0001
71108155|NCT02797821|141721768|OTHER||LS Means Difference|-1.193||||0.0008|TWO_SIDED|95.0|-1.805|-0.581||REML-based repeated measures mixed model (treatment, visit, sex, Baseline PPi, Baseline weight group \[≥median vs \< median\], and study drug lot assignment as factors) with an unstructured covariance structure for within-participant correlation.|REML|A fixed sequence testing procedure was used to control the Type I error rate. A statistical adjustment of p-values was not performed.||A fixed sequence testing procedure was performed to compare the 3.0 mg/kg cohort with the 0.5 mg/kg cohort first. The hypothesis testing for the second comparison of the 2.0 mg/kg cohort compared with the 0.5 mg/kg cohort was only performed if the null hypothesis was rejected for the first comparison at a significance level of 0.05 (p-value \<0.05). The primary endpoint was met if the null hypothesis was rejected for both comparisons at a significance level of 0.05 (both p-values \<0.05).||-0.581|-1.805|0.0008
71108156|NCT02797821|141721769|OTHER||LS Means Difference|-34.047||||0.0128|TWO_SIDED|95.0|-60.171|-7.922||REML-based repeated measures mixed model (treatment, visit, sex, Baseline PPi, Baseline weight group \[≥ median versus \< median\], and study drug lot assignment as factors) with an unstructured covariance structure for within-participant correlation.|Restricted maximum likelihood-based|A statistical adjustment of p-values was not performed.||||-7.922|-60.171|0.0128
71108157|NCT02797821|141721769|OTHER||LS Means Difference|-29.492||||0.0239|TWO_SIDED|95.0|-54.723|-4.261||REML-based repeated measures mixed model (treatment, visit, sex, Baseline PPi, Baseline weight group \[≥ median versus \< median\], and study drug lot assignment as factors) with an unstructured covariance structure for within-participant correlation.|Restricted maximum likelihood-based|A statistical adjustment of p-values was not performed.||||-4.261|-54.723|0.0239
71108158|NCT02271529|141721776|NON_INFERIORITY_OR_EQUIVALENCE|Under the assumption that the mean percent change in stent length upon deployment being 0.2% with a standard deviation of 4%, type I error of 0.05, and two one-sided t-tests, a sample size of at least 30 stents provides power \> 0.90 to determine that the mean length change of stents deployed with the thumbwheel delivery system is within +/-10%.|Mean percent change|-1.0|||<|0.01|TWO_SIDED|95.0|-1.5|-0.4|||two one-sided t-tests|||||-0.4|-1.5|<0.01
71108159|NCT01492426|141721781|NON_INFERIORITY_OR_EQUIVALENCE|Test of noninferiority was based on noninferiority margin of -12% and 2-sided alpha level of 5%. That is, if the lower bound of the 95% CI \> -12%, the Daclatasvir arm would be considered nonnferior to the telaprevir arm.|Percentage difference|4.3|STANDARD_DEVIATION|3.885|||TWO_SIDED|95.0|-3.3|11.9||Test of noninferiority carried out by taking a confidence interval (CI) for the difference in rates (daclatasvir arm minus telapravir arm). If lower bound of 95% CI difference exceeded -12%, noninferiority was demonstrated. No p-value was computed.|Stratum-adjusted Mantel-Haenszel|||Percentage difference between SVR12 rate in the experimental and control arms was computed using a stratum-adjusted Mantel-Haenszel confidence interval (95% level) for the difference in rates. The stratification factors were IL28B rs1297860 single nucleotide polymorphism (CC or non-CC) and baseline cirrhosis status (absent or present), unless otherwise indicated.||11.9|-3.3|
70934764|NCT00670488|141369988|OTHER||Cmax GMR|2.67||||||||||||||"The Last Day (Day 27)/Day 1 Cmax GMR was calculated as follows: Last Day (Day 27) Cmax GM ÷ Day 1 Cmax GM.~Cmax GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."||||
71108160|NCT01978145|141721794|NON_INFERIORITY_OR_EQUIVALENCE|Non- inferiority was demonstrated if lower limit of the CI (0.025 one sided significance level) for the difference of the mean change from Baseline in trough FEV1 of FSC administered BID by CB DPI versus FSC administered BID by MD DPI is greater than -45 milliliter (mL).|Mean Difference (Net)|0.025|||||TWO_SIDED|95.0|0.002|0.047|||Repeated Measures Mixed Models|||||0.047|0.002|
70851767|NCT05408637|141191579|OTHER|The Wilcoxon signed-rank test was used to evaluate changes in the BIS across timepoints due to the small sample size and distributional assumptions. Effect sizes were calculated using the rank biserial correlation coefficient (r) to estimate the magnitude of change.|rank biserial correlation coefficient|0.134||||0.42|TWO_SIDED||||||Wilcoxon signed rank test|BIS across timepoints||||||0.42
70851768|NCT05408637|141191579|OTHER|The Wilcoxon signed-rank test was used to evaluate changes in the BRIEF-A across timepoints due to the small sample size and distributional assumptions.||||||0.232|||||||Wilcoxon signed rank test|BRIEF-A across timepoints||||||0.232
70934765|NCT00670488|141369989|OTHER||C48hr GMR|4.33||||||||||||||"The Last Day (Day 27)/Day 1 C48hr GMR was calculated as follows: Last Day (Day 27) C48hr GM ÷ Day 1 C48hr GM.~C48hr GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."||||
70851769|NCT05408637|141191579|OTHER|The Wilcoxon signed-rank test was used to evaluate changes in the i7 Impulsivity across timepoints due to the small sample size and distributional assumptions. Effect sizes were calculated using the rank biserial correlation coefficient (r) to estimate the magnitude of change.|rank biserial correlation coefficient|0.575||||0.06|TWO_SIDED||||||Wilcoxon signed rank test|i7 Impulsivity||||||0.06
70934766|NCT00670488|141369989|OTHER||C48hr GMR|3.58||||||||||||||"The Last Day (Day 27)/Day 1 C48hr GMR was calculated as follows: Last Day (Day 27) C48hr GM ÷ Day 1 C48hr GM.~C48hr GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."||||
70934767|NCT00670488|141369992|OTHER||AUC0-168hr GMR|1.91||||||||||||||The Last Day/Day 1 AUC 0-168 hr GMR was calculated as follows: Last Day AUC 0-168hr GM ÷ Day 1 AUC 0-48hr GM.||||
71057846|NCT02585778|141620866|SUPERIORITY||Odds Ratio (OR)|103.3|||<|0.0001|TWO_SIDED|95.0|24.6|433.1||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||433.1|24.6|<0.0001
71057847|NCT02585778|141620867|SUPERIORITY||Adjusted Mean Difference|-18.7||||0.0039|TWO_SIDED|95.0|-31.4|-6.0||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-6.0|-31.4|0.0039
71057848|NCT02585778|141620867|SUPERIORITY||Adjusted Mean Difference|-18.4|||<|0.0001|TWO_SIDED|95.0|-23.7|-13.2||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-13.2|-23.7|<0.0001
71057849|NCT02585778|141620868|SUPERIORITY||LS Mean Difference|3.9||||0.3434|TWO_SIDED|95.0|-4.2|12.0||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||12.0|-4.2|0.3434
71057850|NCT02585778|141620868|SUPERIORITY||LS Mean Difference|4.4||||0.01|TWO_SIDED|95.0|1.1|7.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||7.7|1.1|0.0100
71057851|NCT02585778|141620869|SUPERIORITY||Adjusted Mean Difference|-5.7||||0.0902|TWO_SIDED|95.0|-12.3|0.9||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||0.9|-12.3|0.0902
71057852|NCT02054338|141620900|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.54|TWO_SIDED|95.0|0.91|1.2|||Log Rank|||Kaplan-Meier curves and life tables by treatment arm to describe time-dependent parameters. Stratified Cox proportional model was used to compare the 2 treatment arms. A stratified Cox proportional hazards model and logistic regression were applied to the progression-free survival and to the tumour response, respectively.||1.20|0.91|0.54
71057853|NCT02054338|141620901|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.86|TWO_SIDED|95.0|0.87|1.19|||Log Rank|||||1.19|0.87|0.86
71057854|NCT02054338|141620902|SUPERIORITY||Hazard Ratio (HR)|11.3||||0.1|TWO_SIDED|95.0|8.7|14.4|||Log Rank|||||14.4|8.7|0.10
71057855|NCT00911300|141620937|SUPERIORITY_OR_OTHER||Percentage of participants|0.5||||1|TWO_SIDED|95.0|-2.0|3.1|||Fisher Exact||The estimated value is the absolute percent difference between Fondaparinux and UFH/VKA.|||3.1|-2.0|1.000
71057856|NCT00396565|141620970|SUPERIORITY_OR_OTHER||Least squares mean difference|-12.7|STANDARD_ERROR_OF_MEAN|2.26|<|0.0001||95.0|-17.16|-8.25|||ANCOVA|ANCOVA model with treatment as a factor and baseline score as a covariate||||-8.25|-17.16|<0.0001
71057857|NCT00396565|141620971|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.8|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001||95.0|-5.17|-2.51|||ANCOVA|ANCOVA model with treatment as a factor and with baseline score as a covariate.||||-2.51|-5.17|<0.0001
71057858|NCT00396565|141620972|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001||95.0|-3.71|-1.33|||ANCOVA|ANCOVA model with treatment as a factor and with baseline score as a covariate||||-1.33|-3.71|<0.0001
71057859|NCT00396565|141620973|SUPERIORITY_OR_OTHER||Least squares mean difference|-6.2|STANDARD_ERROR_OF_MEAN|1.21|<|0.0001||95.0|-8.58|-3.8|||ANCOVA|ANCOVA model with treatment as a factor, and with baseline score as a covariate||||-3.80|-8.58|<0.0001
71057860|NCT00396565|141620974|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Fisher Exact|||||||0.0007
71057861|NCT00396565|141620975|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001||95.0|-0.84|-0.34|||ANCOVA|ANCOVA model with treatment as a factor, and baseline score as a covariate||||-0.34|-0.84|<0.0001
70934768|NCT00670488|141369992|OTHER||AUC 0-168hr GMR|1.54||||||||||||||The Last Day/Day 1 AUC 0-168 hr GMR was calculated as follows: Last Day AUC 0-168hr GM ÷ Day 1 AUC 0-48hr GM.||||
70934769|NCT00670488|141369993|OTHER||Cmax GMR|1.95||||||||||||||The Last Day/Day 1 Cmax GMR was calculated as follows: Last Day Cmax GM ÷ Day 1 Cmax GM.||||
70934770|NCT00670488|141369993|OTHER||Cmax GMR|1.33||||||||||||||The Last Day/Day 1 Cmax GMR was calculated as follows: Last Day Cmax GM ÷ Day 1 Cmax GM.||||
70934771|NCT00670488|141369994|OTHER||C48hr GMR|1.61||||||||||||||The Last Day/Day 1 C48hr GMR was calculated as follows: Last Day C48hr GM ÷ Day 1 C48hr GM.||||
70934772|NCT00670488|141369994|OTHER||C48hr GMR|1.86||||||||||||||The Last Day/Day 1 C48hr GMR was calculated as follows: Last Day C48hr GM ÷ Day 1 C48hr GM.||||
70934773|NCT00670488|141369994|OTHER||C48hr GMR|1.49||||||||||||||The Last Day/Day 1 C48hr GMR was calculated as follows: Last Day C48hr GM ÷ Day 1 C48hr GM.||||
70934774|NCT00670488|141369997|OTHER||GMR|0.133|||||TWO_SIDED|95.0|0.051|0.347||||||"pAkt Geometric Mean Ratio (GMR)~= Day 15 Geometric Mean (GM) ÷ Baseline GM"||0.347|0.051|
70934775|NCT05553366|141370022|SUPERIORITY|||||||0.0002|||||||ANCOVA|||||||0.0002
70934776|NCT05553366|141370023|SUPERIORITY|||||||0.0016|||||||ANCOVA|||||||0.0016
70934777|NCT05553366|141370024|SUPERIORITY|||||||0.0016|||||||Log Rank|||||||0.0016
70934778|NCT05553366|141370025|SUPERIORITY|||||||0.1315|||||||Log Rank|||||||0.1315
70934779|NCT05553366|141370026|SUPERIORITY|||||||0.0343|||||||Cochran-Mantel-Haenszel|||||||0.0343
70934780|NCT05553366|141370027|SUPERIORITY|||||||0.0014|||||||Pearson's chi-squared test|||||||0.0014
70934781|NCT05553366|141370028|SUPERIORITY|||||||0.0032|||||||ANCOVA|||||||0.0032
70934782|NCT05553366|141370029|SUPERIORITY|||||||0.8592|||||||Log Rank|||||||0.8592
70934783|NCT05553366|141370030|SUPERIORITY|||||||0.9143|||||||Cochran-Mantel-Haenszel|||||||0.9143
70934784|NCT05553366|141370031|SUPERIORITY|||||||0.0205|||||||Wilcoxon rank-sum|||||||0.0205
70934785|NCT00659373|141370153|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.71
70934786|NCT02356198|141370162|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||0.007
70934787|NCT02356198|141370163|SUPERIORITY|||||||0.102|||||||Wilcoxon (Mann-Whitney)|||||||0.102
70934788|NCT02356198|141370164|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||||||0.85
70934789|NCT02356198|141370165|SUPERIORITY|||||||0.454|||||||Chi-squared|||||||0.454
70934790|NCT02356198|141370166|SUPERIORITY|||||||0.212|||||||Fisher Exact|||||||0.212
70934791|NCT03162614|141370167|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.|Vaccine efficacy rate|55.0|||<|0.001|TWO_SIDED|95.0|27.0|72.0|||Fisher Exact|||Efficacy analysis aimed at comparing RTS,S/AS01B administered as full doses at Month 0 and Month 1 and 1/5th dose at Month 7 (AduFx Group versus Control Group).||72|27|<.001
70934792|NCT03162614|141370167|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.|Vaccine efficacy rate|76.0|||<|0.001|TWO_SIDED|95.0|49.0|89.0|||Fisher Exact|||Efficacy analysis aimed at comparing RTS,S/AS01E administered as double full doses at Month 0 and Month 1 and 1/5th double dose at Month 7 (2Ped Fx Group versus Control Group).||89|49|<.001
70934793|NCT03162614|141370167|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.|Vaccine efficacy rate|64.0|||<|0.001|TWO_SIDED|95.0|37.0|79.0|||Fisher Exact|||Efficacy analysis aimed at comparing RTS,S/AS01E administered as full doses at Month 0 and Month 1 and 1/5th dose at Month 7 (PedFx Group versus Control Group).||79|37|<.001
70934794|NCT03162614|141370167|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.|Vaccine efficacy rate|55.0|||<|0.001|TWO_SIDED|95.0|27.0|72.0|||Fisher Exact|||Efficacy analysis aimed at comparing RTS,S/AS01B administered as full dose at Month 0 and 1/5th dose at Month 1 and Month 7 (Adu2Fx Group versus Control Group).||72|27|<.001
70934795|NCT03162614|141370167|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.|Vaccine efficacy rate|29.0||||0.009|TWO_SIDED|95.0|6.0|46.0|||Fisher Exact|||Efficacy analysis aimed at comparing RTS,S/AS01B administered as full dose at Month 0 and 1/5th dose at Month 7 (Adu1Fx Group versus Control Group).||46|6|0.009
70934796|NCT00380250|141370182|SUPERIORITY_OR_OTHER_LEGACY|||||||0.117|||||||van Elteren nonparametric test|Adjusted for center||||||0.117
70934797|NCT00380250|141370183|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|||||||van Elteren nonparametric test|Adjusted for center||||||0.006
70934798|NCT00380250|141370184|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||van Elteren nonparametric test|Adjusted for center||||||0.050
70934799|NCT00380250|141370185|SUPERIORITY_OR_OTHER_LEGACY|||||||0.159|||||||van Elteren nonparametric test|Adjusted for center||||||0.159
70934800|NCT00380250|141370186|SUPERIORITY_OR_OTHER_LEGACY|||||||0.378|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.378
70934801|NCT00380250|141370187|SUPERIORITY_OR_OTHER_LEGACY|||||||0.588|||||||ANCOVA|Adjusted for clinical site||||||0.588
70934802|NCT00380250|141370188|SUPERIORITY_OR_OTHER_LEGACY|||||||0.029||||||No adjustment|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||90% statistical power to detect 70.6% improvement in response with lubiprostone||||0.029
70934803|NCT00380250|141370189|SUPERIORITY_OR_OTHER_LEGACY|||||||0.028||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||||||0.028
71057862|NCT03097991|141621008|SUPERIORITY||Slope|1.86|STANDARD_ERROR_OF_MEAN|1.86||0.32|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.32
70934804|NCT00380250|141370190|SUPERIORITY_OR_OTHER_LEGACY|||||||0.069||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||||||0.069
70934805|NCT00380250|141370191|SUPERIORITY_OR_OTHER_LEGACY|||||||0.098||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||||||0.098
70934806|NCT00380250|141370192|SUPERIORITY_OR_OTHER_LEGACY|||||||0.286|||||||van Elteren nonparametric test|Adjusted for center||||||0.286
70934807|NCT00380250|141370193|SUPERIORITY_OR_OTHER_LEGACY|||||||0.337|||||||van Elteren nonparametric test|Adjusted for center||||||0.337
70934808|NCT00380250|141370194|SUPERIORITY_OR_OTHER_LEGACY|||||||0.334|||||||van Elteren nonparametric test|Adjusted for center||||||0.334
70851770|NCT05408637|141191579|OTHER|The Wilcoxon signed-rank test was used to evaluate changes in the i7 Venturesomeness across timepoints due to the small sample size and distributional assumptions. Effect sizes were calculated using the rank biserial correlation coefficient (r) to estimate the magnitude of change.|rank biserial correlation coefficient|0.275||||0.36|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.36
70934809|NCT00380250|141370195|SUPERIORITY_OR_OTHER_LEGACY|||||||0.242|||||||van Elteren nonparametric test|Adjusted for center||||||0.242
70934810|NCT00380250|141370196|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||van Elteren nonparametric test|Adjusted for center||||||0.030
70934811|NCT00380250|141370197|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|||||||van Elteren nonparametric test|Adjusted for center||||||0.130
70934812|NCT00380250|141370198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.049|||||||van Elteren nonparametric test|Adjusted for center||||||0.049
70934813|NCT00380250|141370199|SUPERIORITY_OR_OTHER_LEGACY|||||||0.348|||||||van Elteren nonparametric test|Adjusted for center||||||0.348
70934814|NCT00380250|141370200|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064|||||||van Elteren nonparametric test|Adjusted for center||||||0.064
70934815|NCT00380250|141370201|SUPERIORITY_OR_OTHER_LEGACY|||||||0.111|||||||van Elteren nonparametric test|||||||0.111
70934816|NCT00380250|141370202|SUPERIORITY_OR_OTHER_LEGACY|||||||0.144|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.144
70934817|NCT00380250|141370203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.168|||||||Cochran-Mantel-Haenszel|Adjusted by pooled center||||||0.168
70934818|NCT00380250|141370204|SUPERIORITY_OR_OTHER_LEGACY|||||||0.615|||||||van Elteren nonparametic test|Adjusted for center||||||0.615
70934819|NCT00380250|141370205|SUPERIORITY_OR_OTHER_LEGACY|||||||0.108|||||||van Elteren nonparametric test|||||||0.108
71057863|NCT03097991|141621008|SUPERIORITY||Slope|-0.84|STANDARD_ERROR_OF_MEAN|1.33||0.53|TWO_SIDED||||||Mixed Models Analysis||Group Effect|||||.53
71057864|NCT03097991|141621009|SUPERIORITY||Slope|-3.04|STANDARD_ERROR_OF_MEAN|1.63||0.07|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.07
71057865|NCT03097991|141621009|SUPERIORITY||Slope|0.54|STANDARD_ERROR_OF_MEAN|1.36||0.69|TWO_SIDED||||||Mixed Models Analysis||||Group Effect|||.69
71057866|NCT03097991|141621010|SUPERIORITY||Slope|2.44|STANDARD_ERROR_OF_MEAN|2.0||0.22|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.22
71057867|NCT03097991|141621010|SUPERIORITY||Slope|0.84|STANDARD_ERROR_OF_MEAN|1.33||0.53|TWO_SIDED||||||Mixed Models Analysis||Group effect|||||.53
71057868|NCT03097991|141621011|SUPERIORITY||Slope|-1.73|STANDARD_ERROR_OF_MEAN|1.76||0.33|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.33
71057869|NCT03097991|141621011|SUPERIORITY||Slope|0.54|STANDARD_ERROR_OF_MEAN|1.36||0.69|TWO_SIDED||||||Mixed Models Analysis||Group Effect|||||.69
71057870|NCT03097991|141621012|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.17||0.81|TWO_SIDED||||||Mixed Models Analysis||Group Effect|||||.81
71057871|NCT03097991|141621012|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.56|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.56
71057872|NCT03097991|141621013|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.13||0.77|TWO_SIDED||||||Mixed Models Analysis||Group Effect|||||.77
71057873|NCT03097991|141621013|SUPERIORITY||Slope|-0.003|STANDARD_ERROR_OF_MEAN|0.02||0.85|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.85
71057874|NCT03097991|141621014|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.56|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.56
71057875|NCT03097991|141621014|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.17||0.81|TWO_SIDED||||||Mixed Models Analysis||Group Effect|||||.81
71057876|NCT03097991|141621015|SUPERIORITY||Slope|-0.003|STANDARD_ERROR_OF_MEAN|0.02||0.85|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint effect|||||.85
71057877|NCT03097991|141621015|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.13||0.77|TWO_SIDED||||||Mixed Models Analysis||Group Effect|||||.77
71057878|NCT03097991|141621016|SUPERIORITY||Slope|21.01|STANDARD_ERROR_OF_MEAN|5.91|<|0.001|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||<.001
71057879|NCT03097991|141621016|SUPERIORITY||Slope|2.98|STANDARD_ERROR_OF_MEAN|4.75|<|0.001|TWO_SIDED||||||Mixed Models Analysis||Group|||||<.001
71057880|NCT03097991|141621017|SUPERIORITY||Slope|0.68|STANDARD_ERROR_OF_MEAN|0.49|<|0.05|TWO_SIDED||||||Mixed Models Analysis|linear mixed effects|Group|||||<.05
71057881|NCT03097991|141621017|SUPERIORITY||Slope|0.26|STANDARD_ERROR_OF_MEAN|0.6|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||<.05
71057882|NCT03097991|141621018|SUPERIORITY||Slope|3.52|STANDARD_ERROR_OF_MEAN|4.14||0.39|TWO_SIDED||||||Mixed Models Analysis||Group|"We analyzed the CTS scales Psychological Aggression and Physical Assault. Inspection of the latter in the raw data and descriptives showed extremely consistent selection of the lowest value of the scale (no incidents of assault) across all respondents, so we did not conduct inferential tests."||||.39
71057883|NCT03097991|141621018|SUPERIORITY||Slope|-13.38|STANDARD_ERROR_OF_MEAN|4.86|<|0.005|TWO_SIDED||||||Mixed Models Analysis||Group x Time|||||<.005
71057884|NCT03097991|141621019|SUPERIORITY||Slope|-1.17|STANDARD_ERROR_OF_MEAN|1.25||0.24|TWO_SIDED||||||Mixed Models Analysis||Group|||||.24
71057885|NCT03097991|141621019|EQUIVALENCE|ANOVA found a main effect of group, F(1, 155) = 6.85, p \< .05, η2G = .04.|Mean Difference (Final Values)|6.85|||<|0.05|TWO_SIDED||||||ANOVA||Group|||||<.05
71057886|NCT03097991|141621020|SUPERIORITY||Slope|-2.53|STANDARD_ERROR_OF_MEAN|1.04||0.02|TWO_SIDED||||||Mixed Models Analysis||Parent x Group|||||.02
71057887|NCT03097991|141621020|SUPERIORITY||Slope|0.45|STANDARD_ERROR_OF_MEAN|0.78||0.56|TWO_SIDED||||||Mixed Models Analysis||Group|||||.56
70851771|NCT05408637|141191580|OTHER|Non-parametric tests were employed to evaluate changes across MOODS-SR Baseline to Day 5 due to the small sample size and distributional assumptions. The Wilcoxon signed-rank tests were applied for pairwise comparisons. Effect sizes were calculated using Cohen's d to estimate the magnitude of change.|Cohen's d|0.12||||0.6|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.6
70851772|NCT05408637|141191580|OTHER|Non-parametric tests were employed to evaluate changes across MOODS-SR Baseline to Follow Up due to the small sample size and distributional assumptions. The Wilcoxon signed-rank tests were applied for pairwise comparisons. Effect sizes were calculated using Cohen's d to estimate the magnitude of change.|Cohen's d|0.24||||0.2|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.2
70934820|NCT00380250|141370206|SUPERIORITY_OR_OTHER_LEGACY|||||||0.483|||||||van Elteren nonparametric test|||||||0.483
71025048|NCT03280537|141557237|SUPERIORITY||Difference in Least Squares Means|-0.5|STANDARD_ERROR_OF_MEAN|0.15||0.0017|TWO_SIDED|95.0|-0.8|-0.19||Tested at the two-sided 0.05 significance level. There was no adjustment for multiplicity for the co-primary outcome measures.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NCS, treatment and baseline NCS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The primary analysis tested the null hypothesis that no treatment group difference existed for change from baseline in NCS at Week 24. As NPS and NCS are co-primary outcome measures, both null hypotheses for NPS and NCS must be rejected, with parameter estimates indicating a benefit of omalizumab over placebo, for the study to be deemed positive.||-0.19|-0.80|0.0017
71025049|NCT03280537|141557238|SUPERIORITY||Difference in Least Squares Means|-0.45|STANDARD_ERROR_OF_MEAN|0.14||0.0024|TWO_SIDED|95.0|-0.73|-0.16||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline SSS, treatment and baseline SSS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Sense of Smell Score (SSS) at Week 24.||-0.16|-0.73|0.0024
71057888|NCT03097991|141621021|SUPERIORITY||Slope|0.94|STANDARD_ERROR_OF_MEAN|0.9||0.3|TWO_SIDED||||||Mixed Models Analysis||Parent x Group|||||.30
71057889|NCT03097991|141621021|SUPERIORITY||Slope|-0.62|STANDARD_ERROR_OF_MEAN|0.67||0.36|TWO_SIDED||||||Mixed Models Analysis||Group|||||.36
70851773|NCT04975438|141191581|OTHER||Posterior Median Difference|-33.21|||||TWO_SIDED|95.0|-50.96|-14.84|||||The posterior median of the difference (GSK1070806 - placebo) and 95% credible interval in PCFB in the EASI is presented. Analysis was performed using Bayesian analysis under the hypothetical strategy using an informative prior (robust MAP prior).|||-14.84|-50.96|
70851774|NCT04975438|141191582|OTHER||Posterior Median Difference|-9.68|||||TWO_SIDED|95.0|-15.7|-3.6|||||The posterior median of the difference (GSK1070806 - placebo) and 95% credible interval in PCFB in the EASI is presented. Analysis was performed using Bayesian analysis with vague priors and adjusting for baseline EASI.|||-3.60|-15.70|
70934821|NCT00380250|141370207|SUPERIORITY_OR_OTHER_LEGACY|||||||0.491|||||||van Elteren nonparametric test|||||||0.491
70851775|NCT02693132|141191595|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
70851776|NCT02693132|141191596|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
70851777|NCT02693132|141191597|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
70851778|NCT02693132|141191598|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
70851779|NCT02693132|141191599|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
70934822|NCT00380250|141370208|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren nonparametric test|Adjusted for center||||||<0.001
70934823|NCT00380250|141370209|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren nonparametric test|Adjusted for center||||||<0.001
70934824|NCT00380250|141370210|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren nonparametric test|Adjusted for center||||||<0.001
71057890|NCT03097991|141621022|SUPERIORITY||Slope|-0.75|STANDARD_ERROR_OF_MEAN|0.55||0.17|TWO_SIDED||||||Mixed Models Analysis||Parent x Group|||||.17
71057891|NCT03097991|141621022|SUPERIORITY||Slope|0.33|STANDARD_ERROR_OF_MEAN|0.47||0.48|TWO_SIDED||||||Mixed Models Analysis||Group|||||.48
71025050|NCT03280537|141557239|SUPERIORITY||Difference in Least Squares Means|-0.54|STANDARD_ERROR_OF_MEAN|0.14||0.0001|TWO_SIDED|95.0|-0.81|-0.27||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline PRS, treatment and baseline PRS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Posterior Rhinorrhea Score (PRS) at Week 24.||-0.27|-0.81|0.0001
71057892|NCT03097991|141621023|SUPERIORITY||Slope|1.15|STANDARD_ERROR_OF_MEAN|7.34||0.88|TWO_SIDED||||||Mixed Models Analysis||Group|||||.88
71025051|NCT03280537|141557240|SUPERIORITY||Difference in Least Squares Means|-0.91|STANDARD_ERROR_OF_MEAN|0.24||0.0002|TWO_SIDED|95.0|-1.39|-0.44||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NPS, treatment and baseline NPS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the NPS at Week 16.||-0.44|-1.39|0.0002
71025052|NCT03280537|141557241|SUPERIORITY||Difference in Least Squares Means|-0.59|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.87|-0.3||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NCS, treatment and baseline NCS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily NCS at Week 16.||-0.30|-0.87|<0.0001
71025053|NCT03280537|141557242|SUPERIORITY||Difference in Least Squares Means|-15.04|STANDARD_ERROR_OF_MEAN|3.14|<|0.0001|TWO_SIDED|95.0|-21.26|-8.82||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the SNOT-22 score at Week 24.||-8.82|-21.26|<0.0001
71025054|NCT03280537|141557243|SUPERIORITY||Difference in Least Squares Means|-0.63|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.9|-0.35||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline ARS, treatment and baseline ARS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Anterior Rhinorrhea Score (ARS) at Week 24.||-0.35|-0.90|<0.0001
71025055|NCT03280537|141557244|SUPERIORITY||Odds Ratio (OR)|0.2||||0.1594|TWO_SIDED|95.0|0.02|1.89||Tested at the two-sided 0.05 significance level.|Wald Chi-Square|Adjusted for geographic region and asthma/aspirin sensitivity comorbidity status.|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for requirement of rescue medication through Week 24.||1.89|0.02|0.1594
71057893|NCT03097991|141621023|SUPERIORITY||Slope|7.94|STANDARD_ERROR_OF_MEAN|9.0||0.38|TWO_SIDED||||||Mixed Models Analysis||Group x Time|||||.38
71057894|NCT03097991|141621024|SUPERIORITY||Slope|-1.89|STANDARD_ERROR_OF_MEAN|1.05||0.07|TWO_SIDED||||||Mixed Models Analysis||Parent x Group|||||.07
71057895|NCT03097991|141621024|SUPERIORITY||Slope|2.52|STANDARD_ERROR_OF_MEAN|0.74|<|0.001|TWO_SIDED||||||Mixed Models Analysis||Group|||||<.001
71057896|NCT03097991|141621025|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.38||0.92|TWO_SIDED||||||Mixed Models Analysis||Group|||||.92
71108161|NCT01978145|141721795|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.004|||||TWO_SIDED|95.0|-0.019|0.027|||||The estimated value and 95% CI values are provided for Day 28|||0.027|-0.019|
71108162|NCT01978145|141721795|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02|||||TWO_SIDED|95.0|-0.005|0.044|||||The estimated value and 95% CI values are provided for Day 56|||0.044|-0.005|
71108163|NCT01978145|141721796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166||||||95.0|-0.06|0.393||||||||0.393|-0.060|
71057897|NCT03097991|141621025|SUPERIORITY||Slope|1.12|STANDARD_ERROR_OF_MEAN|0.57||0.05|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.05
71057898|NCT03097991|141621026|SUPERIORITY||Slope|0.11|STANDARD_ERROR_OF_MEAN|0.47||0.81|TWO_SIDED||||||Mixed Models Analysis||Group|||||.81
70851780|NCT01168986|141191608|SUPERIORITY_OR_OTHER|||||||0.1|||||||Mixed Models Analysis|||||||0.10
70851781|NCT01168986|141191609|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Mixed Models Analysis|||||||0.18
71057899|NCT03097991|141621026|SUPERIORITY||Slope|-0.67|STANDARD_ERROR_OF_MEAN|0.7||0.34|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.34
71057900|NCT03097991|141621027|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.33||0.76|TWO_SIDED||||||Mixed Models Analysis||Group|||||.76
71057901|NCT03097991|141621027|SUPERIORITY||Slope|0.31|STANDARD_ERROR_OF_MEAN|0.49||0.53|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.53
71057902|NCT03097991|141621028|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.16||0.88|TWO_SIDED||||||Mixed Models Analysis||Group|||||.88
71108164|NCT01978145|141721797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.003|||||TWO_SIDED|95.0|-0.278|0.272|||||The estimated and 95% CI values are presented for Day 28.|||0.272|-0.278|
71108165|NCT01978145|141721797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.069||||||95.0|-0.349|0.212|||||The estimated and 95% CI values are presented for Day 56.|||0.212|-0.349|
71108166|NCT01978145|141721797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.133|||||TWO_SIDED|95.0|-0.413|0.148|||||The estimated and 95% CI values are presented for Day 85.|||0.148|-0.413|
71108167|NCT01978145|141721798|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|||||TWO_SIDED|95.0|-0.7|1.19||||||||1.19|-0.70|
71108168|NCT01978145|141721799|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-1.1|-0.02||||||||-0.02|-1.10|
70941685|NCT04748445|141383934|OTHER||Slope|0.2043|STANDARD_ERROR_OF_MEAN|7.752||0.0095|TWO_SIDED|90.0|0.07585|0.3328|||Mixed Models Analysis|||READ\_MFCC mean 03 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.3328|0.07585|0.0095
71108169|NCT02026011|141721800|SUPERIORITY_OR_OTHER|||||||0.39||||||Medication effect: b = -0.15, SE = 0.17, t = -0.86, p = 0.39|Mixed Models Analysis|||||||0.39
71108170|NCT02026011|141721800|SUPERIORITY_OR_OTHER|||||||0.34||||||Genotype effect: b = 0.20, SE = 0.21, t = 0.96, p = 0.34|Mixed Models Analysis|||||||0.34
71108171|NCT02026011|141721800|SUPERIORITY_OR_OTHER|||||||0.04||||||BrAC effect: b = 0.13, SE = 0.06, t = 2.10, p = 0.04|Mixed Models Analysis|||||||0.04
71108172|NCT02026011|141721800|SUPERIORITY_OR_OTHER|||||||0.47||||||Medication by genotype interaction: b = 0.15, SE = 0.21, t = 0.73, p = 0.47|Mixed Models Analysis|||||||0.47
71108173|NCT02026011|141721800|SUPERIORITY_OR_OTHER|||||||0.13||||||Medication by genotype by BrAC interaction: b = -0.20, SE = 0.13, t = -1.52, p = 0.13|Mixed Models Analysis|||||||0.13
71108174|NCT02026011|141721801|SUPERIORITY_OR_OTHER|||||||0.23||||||Medication effect: b = 0.16, SE = 0.13, t = 1.20, p = 0.23|Mixed Models Analysis|||||||0.23
71108175|NCT02026011|141721801|SUPERIORITY_OR_OTHER|||||||0.09||||||Genotype effect: b = 0.37, SE = 0.22, t = 1.69, p = 0.09|Mixed Models Analysis|||||||0.09
70851782|NCT01168986|141191610|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Mixed Models Analysis|||||||0.87
70851783|NCT01168986|141191611|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||Mixed Models Analysis|||||||0.45
70851784|NCT00776919|141191618|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
71057903|NCT03097991|141621028|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.23||0.95|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.95
71057904|NCT03097991|141621029|SUPERIORITY||Slope|0.82|STANDARD_ERROR_OF_MEAN|1.13||0.47|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.47
71057905|NCT03097991|141621029|SUPERIORITY||Slope|-1.68|STANDARD_ERROR_OF_MEAN|0.93||0.07|TWO_SIDED||||||Mixed Models Analysis||Group|||||.07
71057906|NCT03097991|141621030|SUPERIORITY||Slope|0.54|STANDARD_ERROR_OF_MEAN|1.32||0.68|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.68
71057907|NCT03097991|141621030|SUPERIORITY||Slope|-1.68|STANDARD_ERROR_OF_MEAN|0.93||0.07|TWO_SIDED||||||Mixed Models Analysis||Group|||||.07
71057908|NCT03097991|141621031|SUPERIORITY||Slope|-0.85|STANDARD_ERROR_OF_MEAN|1.9||0.65|TWO_SIDED||||||Mixed Models Analysis||Group|||||.65
71057909|NCT03097991|141621031|SUPERIORITY||Slope|-1.65|STANDARD_ERROR_OF_MEAN|2.44||0.5|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.50
71057910|NCT03097991|141621032|SUPERIORITY||Slope|0.92|STANDARD_ERROR_OF_MEAN|1.3||0.48|TWO_SIDED||||||Mixed Models Analysis||Group|||||.48
71057911|NCT03097991|141621032|SUPERIORITY||Slope|-1.92|STANDARD_ERROR_OF_MEAN|1.72||0.27|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.27
71057912|NCT03097991|141621033|SUPERIORITY||Slope|-1.15|STANDARD_ERROR_OF_MEAN|1.22||0.01|TWO_SIDED||||||Mixed Models Analysis||Group|||||.01
71057913|NCT03097991|141621033|SUPERIORITY||Slope|1.08|STANDARD_ERROR_OF_MEAN|1.96||0.58|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.58
71057914|NCT02211417|141621066|SUPERIORITY|||||||0.057|||||||Cochran-Mantel-Haenszel|||||||0.057
71057915|NCT01198132|141621076|SUPERIORITY_OR_OTHER||Rate ratio|0.8||||0.3797|TWO_SIDED|95.0|0.48|1.32|||Poisson log-linear model|||||1.32|0.48|0.3797
71057916|NCT00490841|141621092|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||1-sided exact binomial test|||"objective is to demonstrate the binary restenosis rate at 9 months is \< 28.6% OPC. Assumptions for the primary endpoint analysis:~* H0: Restenosis Rate ≥ 28.6%~* HA: Restenosis Rate \< 28.6%~* Assumed binary restenosis rate = 20%~* Power = 80%~* One-sided type I error = 5%~With the above assumptions, 161 samples would be required. To account for approximately 20% lost to follow-up rate, 202 subjects will be enrolled in the study. The sample size calculation was performed using PASS 2005."||||< 0.0001
71057917|NCT04700137|141621159|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.31|TWO_SIDED|95.0|-3.0|1.0||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.|A T-score of 50 represents the mean of the US general population (based on the 2010 Census) and 10 T-score units represents one standard deviation. Higher T-score indicates higher loneliness.|Difference in loneliness among patients by intervention arm at follow-up (6 months).||1.0|-3.0|0.31
71057918|NCT04700137|141621159|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.83|TWO_SIDED|95.0|-1.8|2.2||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.|A T-score of 50 represents the mean of the US general population (based on the 2010 Census) and 10 T-score units represents one standard deviation. Higher T-score indicates higher loneliness.|Difference in loneliness among healthcare providers/staff by intervention arm at follow-up (6 months).||2.2|-1.8|0.83
71057919|NCT04700137|141621160|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.05|TWO_SIDED|95.0|0.0|0.5||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in suicidal ideation and behavior (C-SSRS) among patients by intervention arm at follow-up (6 months).||0.5|0.0|0.05
71057920|NCT04700137|141621160|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.2|TWO_SIDED|95.0|-0.4|0.1||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in suicidal ideation and behavior (C-SSRS) among healthcare providers/staff by intervention arm at follow-up (6 months).||0.1|-0.4|0.2
71057921|NCT04700137|141621161|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.45|TWO_SIDED|95.0|-1.5|0.7||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in depression (PHQ-9) among patients by intervention arm at follow-up (6 months).||0.7|-1.5|0.45
71057922|NCT04700137|141621161|SUPERIORITY||Median Difference (Final Values)|0.3||||0.51|TWO_SIDED|95.0|-0.7|1.3||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in depression (PHQ-9) among healthcare providers/staff by intervention arm at follow-up (6 months).||1.3|-0.7|0.51
71025056|NCT03280537|141557245|SUPERIORITY||Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|0.0|20.61||Tested at the two-sided 0.05 significance level.|Fisher Exact|Unadjusted|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for having had surgery for nasal polyps through Week 24.||20.61|0.00|1.0000
71025057|NCT03280537|141557246|SUPERIORITY||Odds Ratio (OR)|4.04||||0.0396|TWO_SIDED|95.0|1.07|15.25|||Wald Chi-Square|Adjusted for Baseline AQLQ, geographic region, and aspirin sensitivity status.|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for number of participants with a change from baseline in AQLQ score of ≥0.5 at Week 24.||15.25|1.07|0.0396
71025058|NCT03280537|141557247|SUPERIORITY||Odds Ratio (OR)|0.2||||0.1594|TWO_SIDED|95.0|0.02|1.89||Tested at the two-sided 0.05 significance level.|Wald Chi-Square|Adjusted for geographic region and asthma/aspirin sensitivity comorbidity status.|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for requirement of rescue treatment through Week 24.||1.89|0.02|0.1594
71025059|NCT03280537|141557248|SUPERIORITY||Odds Ratio (OR)|6.22||||0.0139|TWO_SIDED|95.0|1.23|60.23||Tested at the two-sided 0.05 significance level.|Fisher Exact|Unadjusted|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in reduction in the need for surgery for nasal polyps by Week 24.||60.23|1.23|0.0139
71025060|NCT03280537|141557249|SUPERIORITY||Difference in Least Squares Means|-2.09|STANDARD_ERROR_OF_MEAN|0.46|<|0.0001|TWO_SIDED|95.0|-3.0|-1.18||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline TNSS, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Total Nasal Symptom Score (TNSS) at Week 24.||-1.18|-3.00|<0.0001
70851785|NCT00776919|141191618|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||Cochran-Mantel-Haenszel|||||||0.016
70934825|NCT01321073|141370266|SUPERIORITY||||||<|0.0001|||||||1-sample exact test for Poisson rate|||The rate of catheter-related complications per 1000 patient-days was compared to a pre-specified value of 2.5 / 1000 days. This was calculated based on published complication rates in PAH that included central venous catheter systemic bloodstream infections (0.43-1.13), site infections (0.26-0.87), and complications from catheter thrombosis, mechanical dysfunction, or catheter dislocation in the general central venous catheter population (0.36-0.51). The sum of the upper rates is 2.5.||||<0.0001
70941686|NCT04748445|141383934|OTHER||Slope|-0.0828|STANDARD_ERROR_OF_MEAN|6.413||0.1991|TWO_SIDED|90.0|-0.1891|0.02348|||Mixed Models Analysis|||READ\_MFCC mean 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.02348|-0.1891|0.1991
71057923|NCT04700137|141621162|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.54|TWO_SIDED|95.0|-1.3|0.7||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in anxiety (GAD-7) among patients by intervention arm at follow-up (6 months).||0.7|-1.3|0.54
71057924|NCT04700137|141621162|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.04|TWO_SIDED|95.0|0.1|2.0||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in anxiety (GAD-7) among healthcare providers/staff by intervention arm at follow-up (6 months).||2.0|0.1|0.04
71057925|NCT04700137|141621163|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.84|TWO_SIDED|95.0|-2.1|1.7||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors.|T-score of 50 = mean of the US general population (2010 Census); 10 T-score units = one standard deviation. Higher T-scores = higher stress. T-scores equal to or greater than 60.5 (adults) or 60.8 (adolescents) are moderate or high risk.|Change in stress from baseline to 6 months among patients.||1.7|-2.1|0.84
71057926|NCT04700137|141621163|SUPERIORITY||Mean Difference (Final Values)|1.5||||0.18|TWO_SIDED|95.0|-0.7|3.7||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors.|T-score of 50 = mean of the US general population (2010 Census); 10 T-score units = one standard deviation. Higher T-scores = higher stress. T-scores equal to or greater than 60.5 (adults) or 60.8 (adolescents) are moderate or high risk.|Change in stress from baseline to 6 months among healthcare providers/staff.||3.7|-0.7|0.18
71057927|NCT04700137|141621164|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.38|TWO_SIDED|95.0|-0.6|1.6||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in perceived burdensomeness (INQ15) among patients by intervention arm at follow-up (6 months).||1.6|-0.6|0.38
70851786|NCT00776919|141191618|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
70851787|NCT00776919|141191619|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||<0.001
70941687|NCT04748445|141383934|OTHER||Slope|-0.02415|STANDARD_ERROR_OF_MEAN|5.26||0.6469|TWO_SIDED|90.0|-0.1113|0.06301|||Mixed Models Analysis|||READ\_MFCC mean 05 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.06301|-0.1113|0.6469
71057928|NCT04700137|141621164|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.81|TWO_SIDED|95.0|-0.8|1.0||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in perceived burdensomeness (INQ15) among healthcare providers/staff by intervention arm at follow-up (6 months).||1.0|-0.8|0.81
71108176|NCT02026011|141721801|SUPERIORITY_OR_OTHER|||||||0.84||||||Medication by genotype interaction: b = 0.04, SE = 0.21, t = 0.20, p = 0.84|Mixed Models Analysis|||||||0.84
70851788|NCT00776919|141191619|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||0.015
71108177|NCT02026011|141721801|SUPERIORITY_OR_OTHER|||||||0.05||||||Medication by genotype by BrAC interaction: b = -0.32, SE = 0.16, t = -1.93, p = 0.05|Mixed Models Analysis|||||||0.05
71108178|NCT02026011|141721802|SUPERIORITY_OR_OTHER|||||||0.55||||||Medication effect: b = 0.14, SE = 0.23, t = 0.61, p = 0.55|Mixed Models Analysis|||||||0.55
71108179|NCT02026011|141721802|SUPERIORITY_OR_OTHER|||||||0.77||||||Genotype effect: b = -0.11, SE = 0.37, t = -0.30, p = 0.77|Mixed Models Analysis|||||||0.77
71108180|NCT02026011|141721802|SUPERIORITY_OR_OTHER|||||||0.04||||||BrAC effect: b = 0.30, SE = 0.15, t = 2.02, p = 0.04|Mixed Models Analysis|||||||0.04
71108181|NCT02026011|141721802|SUPERIORITY_OR_OTHER|||||||0.47||||||Medication by genotype interaction: b = -0.21, SE = 0.29, t = -0.72, p = 0.47|Mixed Models Analysis|||||||0.47
71108182|NCT02026011|141721802|SUPERIORITY_OR_OTHER|||||||0.19||||||Medication by genotype by BrAC interaction: b = 0.28, SE = 0.21, t = 1.30, p = 0.19|Mixed Models Analysis|||||||0.19
71108183|NCT02026011|141721804|SUPERIORITY_OR_OTHER|||||||0.14||||||Medication effect: F(1,71) = 2.24, p = 0.14|Poisson Regression|||||||0.14
71108184|NCT02026011|141721804|SUPERIORITY_OR_OTHER|||||||0.02||||||Genotype effect: F(1, 71) = 5.79, p = 0.02|Poisson|||||||0.02
71108185|NCT02026011|141721804|SUPERIORITY_OR_OTHER|||||||0.41||||||Medication by genotype interaction: F(1, 70) = 0.68, p = 0.41.|Poisson|||||||0.41
71108186|NCT02852967|141721826|SUPERIORITY|||||||0.6384|||||||Fisher Exact|||LOCF at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 200 mg QD + placebo (n = 23) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 18) who achieved PASI 75.||||0.6384
71108187|NCT02852967|141721826|SUPERIORITY|||||||0.6419|||||||Fisher Exact|||LOCF at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 200 mg BID + placebo (n = 22) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 18) who achieved PASI 75.||||0.6419
71108188|NCT02852967|141721826|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||LOCF at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 400 mg QD + placebo (n = 21) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 18) who achieved PASI 75.||||> 0.9999
71108189|NCT02852967|141721826|SUPERIORITY|||||||0.3859|||||||Fisher Exact|||LOCF at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 600 mg (n = 26) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 18) who achieved PASI 75.||||0.3859
71108190|NCT02852967|141721826|SUPERIORITY|||||||0.4435|||||||Fisher Exact|||LOCF at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of all subjects treated with belumosudil (n = 92) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 18) who achieved PASI 75||||0.4435
71108191|NCT02852967|141721826|SUPERIORITY|||||||0.2721|||||||Fisher Exact|||Observed at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 200 mg QD + placebo (n = 14) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 10) who achieved PASI 75.||||0.2721
70851789|NCT00776919|141191619|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||<0.001
71108192|NCT02852967|141721826|SUPERIORITY|||||||0.3577|||||||Fisher Exact|||Observed at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 200 mg BID+ Placebo (n = 15) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 10) who achieved PASI 75.||||0.3577
71108193|NCT02852967|141721826|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||Observed at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 500 mg QD + Placebo (n = 17) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 10) who achieved PASI 75.||||> 0.9999
71108194|NCT02852967|141721826|SUPERIORITY|||||||0.3402|||||||Fisher Exact|||Observed at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 600 mg/day (n = 16) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 10) who achieved PASI 75.||||0.3402
71108195|NCT02852967|141721826|SUPERIORITY|||||||0.3542|||||||Fisher Exact|||Observed at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of all subjects treated with belumosudil 200 mg QD + Placebo (n = 62) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 10) who achieved PASI 75.||||0.3542
71108196|NCT02852967|141721830|SUPERIORITY|||||||0.5728|||||||Fisher Exact|||Percentage of subjects treated with belumosudil compared to placebo who had a PGA rating of clear or almost clear||||0.5728
71108197|NCT02852967|141721830|SUPERIORITY|||||||0.1962|||||||Fisher Exact|||Percentage of subjects treated with belumosudil compared to placebo who had a PGA rating of clear or almost clear||||0.1962
71108198|NCT02852967|141721830|SUPERIORITY|Percentage of subjects treated with belumosudil compared to placebo who had a PGA rating of clear or almost clear|||||>|0.9999|||||||Fisher Exact|||||||> 0.9999
71108199|NCT02852967|141721830|SUPERIORITY|||||||0.5583|||||||Fisher Exact|||Percentage of subjects treated with belumosudil compared to placebo who had a PGA rating of clear or almost clear||||0.5583
71108200|NCT02852967|141721830|SUPERIORITY|||||||0.2538|||||||Fisher Exact|||Percentage of subjects treated with belumosudil compared to placebo who had a PGA rating of clear or almost clear||||0.2538
70851790|NCT00776919|141191620|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||<0.001
70851791|NCT00776919|141191620|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||0.102
70934826|NCT01638000|141370269|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was concluded if the lower limit of the 95% CI for difference of adjusted change from baseline between solifenacin 5 mg and mirabegron 50 mg was \> -0.20. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg. Overall power calculation was 80% for a 1-sided test and significance level of 0.025.|least squares mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.124||0.15|TWO_SIDED|95.0|-0.42|0.06||If p\<0.05, this indicated superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||The non-inferiority of mirabegron vs. solifencacin on the change from baseline to final visit in the mean number of micturitions per 24 hours.||0.06|-0.42|0.15
71057929|NCT04700137|141621164|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.73|TWO_SIDED|95.0|-2.6|1.8||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in thwarted belongingness (INQ15) among patients by intervention arm at follow-up (6 months).||1.8|-2.6|0.73
70851792|NCT00776919|141191620|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||<0.001
70934827|NCT01638000|141370270|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.53||||0.03|TWO_SIDED|95.0|1.04|2.25||If P \<0.05, this indicates superiority in favor of the treatment group with the smallest percentage of participants with at least 1 TEAE of dry mouth, constipation or blurred vision during the double-blind period at the final visit.|Regression, Logistic|Included treatment group, sex, age group (\< 65, ≥ 65), number of prior antimuscarinics (1, ≥ 2) and geographic region as factors.||Difference vs Mirabegron. Differences of the percentages were calculated by subtracting the percentage of mirabegron 50 mg group from the percentage of solifenacin 5 mg group.||2.25|1.04|0.030
71057930|NCT04700137|141621164|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.24|TWO_SIDED|95.0|-0.8|3.2||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in thwarted belongingness (INQ15) among healthcare providers/staff by intervention arm at follow-up (6 months).||3.2|-0.8|0.24
71057931|NCT04700137|141621166|SUPERIORITY||Risk Difference (RD)|-5.6||||0.12|TWO_SIDED|95.0|-12.5|1.4||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased tobacco use among patients randomized to CC+ vs CC||1.4|-12.5|0.12
71057932|NCT04700137|141621166|SUPERIORITY||Risk Difference (RD)|-6.1||||0.03|TWO_SIDED|95.0|-11.5|-0.7||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased tobacco use among healthcare providers/staff randomized to CC+ vs CC||-0.7|-11.5|0.03
71057933|NCT04700137|141621166|SUPERIORITY||Risk Difference (RD)|-1.1||||0.83|TWO_SIDED|95.0|-10.7|8.5||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased alcohol use among patients randomized to CC+ vs CC||8.5|-10.7|0.83
71057934|NCT04700137|141621166|SUPERIORITY||Risk Difference (RD)|2.2||||0.67|TWO_SIDED|95.0|-8.0|12.5||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased alcohol use among healthcare providers/staff randomized to CC+ vs CC||12.5|-8.0|0.67
71057935|NCT04700137|141621166|SUPERIORITY||Risk Difference (RD)|2.9||||0.42|TWO_SIDED|95.0|-4.1|9.9||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased marijuana/cannabis use among patients randomized to CC+ vs CC||9.9|-4.1|0.42
71057936|NCT04700137|141621166|SUPERIORITY||Risk Difference (RD)|-2.1||||0.53|TWO_SIDED|95.0|-8.7|4.5||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased marijuana/cannabis use among healthcare providers/staff randomized to CC+ vs CC||4.5|-8.7|0.53
70851793|NCT00776919|141191621|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||<0.001
70941688|NCT04748445|141383934|OTHER||Slope|-0.1209|STANDARD_ERROR_OF_MEAN|4.904||0.015|TWO_SIDED|90.0|-0.2022|-0.03967|||Mixed Models Analysis|||READ\_MFCC mean 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.03967|-0.2022|0.0150
71025061|NCT03280537|141557250|SUPERIORITY||Difference in Least Squares Means|3.86|STANDARD_ERROR_OF_MEAN|1.16||0.0011|TWO_SIDED|95.0|1.57|6.15||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline UPSIT, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the UPSIT score at Week 24.||6.15|1.57|0.0011
71025062|NCT02004847|141557270|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||t-test, 2 sided|||Statistically analysed were the difference in change from baseline to the end of treatment (week 12) of the target plaque compared to the control plaque.||||0.0005
71025063|NCT02004847|141557271|SUPERIORITY_OR_OTHER|||||||0.0036|TWO_SIDED||||||t-test, 2 sided|||Statistically analysed were the difference in change from baseline to the end of treatment during the attack period (week 4) of the target plaque compared to the control plaque.||||0.0036
71057937|NCT04700137|141621166|SUPERIORITY||Risk Difference (RD)|-2.5||||0.2|TWO_SIDED|95.0|-6.3|1.4||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased illicit drug use among patients randomized to CC+ vs CC||1.4|-6.3|0.20
71025064|NCT02004847|141557272|SUPERIORITY_OR_OTHER|||||||0.3075|TWO_SIDED||||||t-test, 2 sided|||Statistically analysed were the difference in change from end of treatment (week 12, visit 7) to end of follow up (week 16, visit 8) of the target plaque compared to the control plaque.||||0.3075
71025065|NCT02004847|141557273|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||t-test, 2 sided|||Statistically analysed were the difference in change from baseline to week 4 of the target plaque compared to the control plaque.||||0.0140
71025066|NCT02004847|141557273|SUPERIORITY_OR_OTHER|||||||0.0064|TWO_SIDED||||||t-test, 2 sided|||Statistically analysed were the difference in change from baseline to week 12 of the target plaque compared to the control plaque.||||0.0064
71025067|NCT02004847|141557273|SUPERIORITY_OR_OTHER|||||||0.102|TWO_SIDED||||||t-test, 2 sided|||Statistically analysed were the difference in change from baseline to week 16 of the target plaque compared to the control plaque.||||0.1020
71025068|NCT03342898|141557286|NON_INFERIORITY|Non-inferiority of the immune response was performed only between YF + TDV (Group 3) and YF + Placebo (Group 1) at Day 120. Non-inferiority between Group 3 and Group 1 was concluded if the upper bound of the 95% CI for the seroprotection rate difference (Group 1 - Group 3) was less than 5%.|Seroprotection Rate Difference|0.4|||||TWO_SIDED|95.0|-1.85|2.69|||||The Newcombe score method was used to compute the 95% CI of the seroprotection rate difference.|||2.69|-1.85|
71025069|NCT03342898|141557287|NON_INFERIORITY|Non-inferiority of the immune response was performed only between TDV + YF (Group 3) and TDV + Placebo (Group 2) at Day 120. Non-inferiority between Group 3 and Group 2 was concluded if the upper bound of the 95% CI for the GMT ratio (Group 2/Group 3) was less than 2.0.|Geometric Mean Ratio|1.6|||||TWO_SIDED|95.0|1.19|2.22|||||Analysis of variance (ANOVA) model was used for analysis, including log-transformed value of titer as the dependent variable and trial group as a factor.|Day 120, DENV-1||2.22|1.19|
71025070|NCT03342898|141557287|NON_INFERIORITY|Non-inferiority of the immune response was performed only between TDV + YF (Group 3) and TDV + Placebo (Group 2) at Day 120. Non-inferiority between Group 3 and Group 2 was concluded if the upper bound of the 95% CI for the GMT ratio (Group 2/Group 3) was less than 2.0.|Geometric Mean Ratio|1.3||||||95.0|1.03|1.75|||||ANOVA model was used for analysis, including log-transformed value of titer as the dependent variable and trial group as a factor.|Day 120, DENV-2||1.75|1.03|
71025071|NCT03342898|141557287|NON_INFERIORITY|Non-inferiority of the immune response was performed only between TDV + YF (Group 3) and TDV + Placebo (Group 2) at Day 120. Non-inferiority between Group 3 and Group 2 was concluded if the upper bound of the 95% CI for the GMT ratio (Group 2/Group 3) was less than 2.0.|Geometric Mean Ratio|1.3||||||95.0|0.99|1.61|||||ANOVA model was used for analysis, including log-transformed value of titer as the dependent variable and trial group as a factor.|Day 120, DENV-3||1.61|0.99|
71025072|NCT03342898|141557287|NON_INFERIORITY|Non-inferiority of the immune response was performed only between TDV + YF (Group 3) and TDV + Placebo (Group 2) at Day 120. Non-inferiority between Group 3 and Group 2 was concluded if the upper bound of the 95% CI for the GMT ratio (Group 2/Group 3) was less than 2.0.|Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.89|1.46|||||ANOVA model was used for analysis, including log-transformed value of titer as the dependent variable and trial group as a factor.|Day 120, DENV-4||1.46|0.89|
71025073|NCT03342898|141557291|NON_INFERIORITY|Non-inferiority of the immune response was performed only between YF + TDV (Group 3) and YF + Placebo (Group 1) at Day 30. Non-inferiority between Group 3 and Group 1 was concluded if the upper bound of the 95% CI for the GMT ratio (Group 1/Group 3) was less than 2.0.|Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.77|1.26|||||ANOVA model was used for analyses, including the log-transformed value of titer as the dependent variable and trial group as a factor.|||1.26|0.77|
71025074|NCT02661126|141557305|OTHER|Geometric least-squares mean ratio (GMR) of AUC0-last in Moderate RI/Healthy Participants.|GMR of AUC0-last in Moderate RI/Healthy|2.02|||||TWO_SIDED|90.0|1.4|2.92||||||||2.92|1.40|
71025075|NCT02661126|141557306|OTHER|GMR of AUC0-∞ in Moderate RI/Healthy Participants|GMR of AUC0-∞ in Moderate RI/Healthy|2.0|||||TWO_SIDED|90.0|1.39|2.89||||||||2.89|1.39|
71025076|NCT02661126|141557307|OTHER|GMR of AUC0-24 in Moderate RI/Healthy Participants|GMR of AUC0-24 in Moderate RI/Healthy|2.02|||||TWO_SIDED|90.0|1.39|2.92||||||||2.92|1.39|
71025077|NCT02661126|141557308|OTHER|GMR of Cmax in Moderate RI/Healthy Participants|GMR of Cmax in Moderate RI/Healthy|1.92|||||TWO_SIDED|90.0|1.35|2.74||||||||2.74|1.35|
71025078|NCT02661126|141557314|OTHER|GMR of AUC0-last in Moderate RI/Healthy Participants.|GMR of AUC0-last in Moderate RI/Healthy|1.94|||||TWO_SIDED|90.0|1.39|2.72||||||||2.72|1.39|
70934828|NCT01638000|141370271|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.117||0.71|TWO_SIDED|95.0|-0.19|0.27||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.27|-0.19|0.71
70934829|NCT01638000|141370271|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.119||0.053|TWO_SIDED|95.0|-0.47|0.0||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.00|-0.47|0.053
70934830|NCT01638000|141370271|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.125||0.12|TWO_SIDED|95.0|-0.44|0.05||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.05|-0.44|0.12
70934831|NCT01638000|141370272|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.9||||0.33|TWO_SIDED|95.0|0.73|1.11||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 4 Rate Ratio vs. Mirabegron.||1.11|0.73|0.33
70934832|NCT01638000|141370272|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.84||||0.21|TWO_SIDED|95.0|0.64|1.1||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 8 Rate Ratio vs. Mirabegron.||1.10|0.64|0.21
70934833|NCT01638000|141370272|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.97||||0.83|TWO_SIDED|95.0|0.71|1.32||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates||Week 12 Rate Ratio vs. Mirabegron.||1.32|0.71|0.83
71025079|NCT02661126|141557315|OTHER|GMR of AUC0-∞ in Moderate RI/Healthy Participants|GMR of AUC0-∞ in Moderate RI/Healthy|2.02|||||TWO_SIDED|90.0|1.5|2.74||||||||2.74|1.50|
70934834|NCT01638000|141370272|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.92||||0.57|TWO_SIDED|95.0|0.68|1.24||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Final Visit Rate Ratio vs. Mirabegron||1.24|0.68|0.57
70934835|NCT01638000|141370273|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.089||0.36|TWO_SIDED|95.0|-0.25|0.1||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From stratified rank ANCOVA analysis.||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.10|-0.25|0.36
70934836|NCT01638000|141370273|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.13||0.12|TWO_SIDED|95.0|-0.48|0.03||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From the stratified rank ANCOVA analysis.||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.03|-0.48|0.12
70934837|NCT01638000|141370273|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.163||0.47|TWO_SIDED|95.0|-0.57|0.07||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From the stratified rank ANCOVA analysis.||Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||0.07|-0.57|0.47
70934838|NCT01638000|141370274|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.92||||0.44|TWO_SIDED|95.0|0.74|1.14||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 4 Rate Ratio vs. Mirabegron||1.14|0.74|0.44
71057938|NCT04700137|141621166|SUPERIORITY||Risk Difference (RD)|-0.7||||0.62|TWO_SIDED|95.0|-3.4|2.0||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased illicit drug use among healthcare providers/staff randomized to CC+ vs CC||2.0|-3.4|0.62
71025080|NCT02661126|141557316|OTHER|GMR of AUC0-24 in Moderate RI/Healthy Participants|GMR of AUC0-24 in Moderate RI/Healthy|1.72|||||TWO_SIDED|90.0|1.15|2.56||||||||2.56|1.15|
71025081|NCT02661126|141557317|OTHER|GMR of Cmax in Moderate RI/Healthy Participants|GMR of Cmax in Moderate RI/Healthy|1.85|||||TWO_SIDED|90.0|1.2|2.87||||||||2.87|1.20|
71025082|NCT02661126|141557318|OTHER|GMR of C24 in Moderate RI/Healthy Participants|GMR of C24 in Moderate RI/Healthy|2.03|||||TWO_SIDED|90.0|1.38|2.97||||||||2.97|1.38|
71025083|NCT02661126|141557322|OTHER|GMR of AUC0-last in Moderate RI/Healthy Participants.|GMR of AUC0-last in Moderate RI/Healthy|1.91|||||TWO_SIDED|90.0|1.44|2.53||||||||2.53|1.44|
70851794|NCT00776919|141191621|SUPERIORITY_OR_OTHER|||||||0.032||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||0.032
70934839|NCT01638000|141370274|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.79||||0.11|TWO_SIDED|95.0|0.6|1.06||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates||Week 8 Rate Ratio vs. Mirabegron||1.06|0.60|0.11
70934840|NCT01638000|141370274|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.05||||0.78|TWO_SIDED|95.0|0.76|1.45||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates||Week 12 Rate Ratio vs. Mirabegron||1.45|0.76|0.78
71025084|NCT02661126|141557323|OTHER|GMR of AUC0-∞ in Moderate RI/Healthy Participants|GMR of AUC0-∞ in Moderate RI/Healthy|1.97|||||TWO_SIDED|90.0|1.48|2.63||||||||2.63|1.48|
71025085|NCT02661126|141557324|OTHER|GMR of AUC0-24 in Moderate RI/Healthy Participants|GMR of AUC0-24 in Moderate RI/Healthy|1.96|||||TWO_SIDED|90.0|1.54|2.48||||||||2.48|1.54|
71057939|NCT04700137|141621167|SUPERIORITY||Risk Difference (RD)|-4.5||||0.41|TWO_SIDED|95.0|-15.4|6.3||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Difference in proportion of patients attending mental healthcare appointments by intervention arm at follow-up (6 months).||6.3|-15.4|0.41
71057940|NCT04700137|141621167|SUPERIORITY||Risk Difference (RD)|5.5||||0.31|TWO_SIDED|95.0|-5.2|16.2||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Difference in proportion of healthcare providers/staff attending mental healthcare appointments by intervention arm at follow-up (6 months).||16.2|-5.2|0.31
71057941|NCT00174954|141621168|SUPERIORITY_OR_OTHER|||||||0.785||95.0||||The a priori threshold for statistical significance was 0.05.|paired t-test|||||||0.785
71057942|NCT00174954|141621169|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||The a priori threshold for statistical significance is 0.05.|paired t-test|||||||0.020
71057943|NCT00839254|141621170|SUPERIORITY|VE (defined as 1 minus Relative Risk (RR)) was calculated by comparing numbers of culture-confirmed IPD. The number of subjects with IPD in each cluster was compared between groups (10PN3+1 vs Control). This comparison was done using a negative binomial log-linear model with correction for dispersion group- and cluster-related effect.|VE (1-RR)|100.0|||<|0.0001|TWO_SIDED|95.0|82.8|100.0||P-value was calculated using a classical log linear Poisson regression with strata, without taking into account the multiplicity of the endpoints.|Regression, Linear|||Analysis aimed at providing an estimate of vaccine effectiveness (VE) at preventing culture-confirmed IPD by comparing PYARs between groups taking into account the following parameters: T, n, n+ (number of clusters with at least one event culture-confirmed ID), and n/T. VE of the 10Pn vaccine in preventing culture-confirmed IPD due to the 10 vaccine serotypes was demonstrated if the 2-sided p-value calculated for the null hypothesis H0 = (vaccine-type \[VT\] IPD VE = 0%) was lower than (\<) 5%.||100|82.8|<0.0001
71057944|NCT00839254|141621171|SUPERIORITY|VE (defined as 1 minus Relative Risk (RR)) was calculated by comparing numbers of culture-confirmed IPD. The number of subjects with IPD in each cluster was compared between groups (10PN2+1 vs Control). This comparison was done using a negative binomial log-linear model with correction for dispersion group- and cluster-related effect.|VE (1-RR)|91.8|||=|0.0009|TWO_SIDED|95.0|58.3|99.6||p-value was calculated using a classical log linear Poisson regression with strata, without taking into account the multiplicity of the endpoints.|Regression, Linear|||Analysis aimed at providing an estimate of vaccine effectiveness (VE) at preventing culture-confirmed IPD by comparing PYARs between groups taking into account the following parameters: T, n, n+ (number of clusters with at least one event culture-confirmed ID), and n/T. VE of the 10Pn vaccine in preventing culture-confirmed IPD due to the 10 vaccine serotypes was demonstrated if the 2-sided p-value calculated for the null hypothesis H0 = (vaccine-type \[VT\] IPD VE = 0%) was lower than (\<) 5%.||99.6|58.3|= 0.0009
71057945|NCT02687529|141621274|EQUIVALENCE|The number of positive and negative CST001 assay results for each subject, across all sites and operators were compared. In order for a subject to have a concordant result, the same assay call must be observed for all replicates across all sites (6/6).|proportion of concordant calls|83.33|||||TWO_SIDED|95.0|72.13|91.38||||||||91.38|72.13|
70851795|NCT00776919|141191621|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||<0.001
70934841|NCT01638000|141370274|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.97||||0.85|TWO_SIDED|95.0|0.71|1.33||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates||Final Visit Rate Ratio vs. Mirabegron||1.33|0.71|0.85
71025086|NCT02661126|141557325|OTHER|GMR of Cmax in Moderate RI/Healthy Participants|GMR of Cmax in Moderate RI/Healthy|1.7|||||TWO_SIDED|90.0|1.29|2.24||||||||2.24|1.29|
71025087|NCT02661126|141557326|OTHER|GMR of C24 in Moderate RI/Healthy Participants|GMR of C24 in Moderate RI/Healthy|1.94|||||TWO_SIDED|90.0|1.47|2.57||||||||2.57|1.47|
71025088|NCT02661126|141557329|OTHER|GMR of AUC0-last in Moderate RI/Healthy Participants.|GMR of AUC0-last in Moderate RI/Healthy|1.33|||||TWO_SIDED|90.0|0.65|2.75||||||||2.75|0.65|
71057946|NCT02374138|141621279|SUPERIORITY|||||||0.93||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 6 Months||||0.93
71057947|NCT02374138|141621280|SUPERIORITY|||||||0.87||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 6 month follow up||||0.87
71057948|NCT02374138|141621280|SUPERIORITY|||||||0.25||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 12 month follow up||||0.25
71057949|NCT02374138|141621282|SUPERIORITY|||||||0.35||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||ICS Use at 6 Month Follow Up||||0.35
71057950|NCT02374138|141621282|SUPERIORITY|||||||0.34||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||ICS Use at 12 Month Follow Up||||0.34
71057951|NCT02374138|141621282|SUPERIORITY|||||||0.35||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||LTRA Use at 6 Months||||0.35
71025089|NCT02661126|141557330|OTHER|GMR of AUC0-∞ in Moderate RI/Healthy Participants|GMR of AUC0-∞ in Moderate RI/Healthy|1.59|||||TWO_SIDED|90.0|0.79|3.19||||||||3.19|0.79|
70941689|NCT04748445|141383934|OTHER||Slope|0.02617|STANDARD_ERROR_OF_MEAN|4.639||0.5736|TWO_SIDED|90.0|-0.0507|0.103|||Mixed Models Analysis|||READ\_MFCC mean 07 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1030|-0.05070|0.5736
71025090|NCT02661126|141557331|OTHER|GMR of AUC0-24 in Moderate RI/Healthy Participants|GMR of AUC0-24 in Moderate RI/Healthy|1.15|||||TWO_SIDED|90.0|0.51|2.57||||||||2.57|0.51|
71025091|NCT02661126|141557332|OTHER|GMR of Cmax in Moderate RI/Healthy Participants|GMR of Cmax in Moderate RI/Healthy|1.23|||||TWO_SIDED|90.0|0.5|3.05||||||||3.05|0.50|
71025092|NCT02661126|141557333|OTHER|GMR of C24 in Moderate RI/Healthy Participants|GMR of C24 in Moderate RI/Healthy|1.28|||||TWO_SIDED|90.0|0.56|2.91||||||||2.91|0.56|
71057952|NCT02374138|141621282|SUPERIORITY|||||||0.62||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||LTRA use at 12 Month Follow Up||||0.62
71057953|NCT02374138|141621283|SUPERIORITY|||||||0.63||||||Adjusted for child age, gender, and baseline value|Generalized Linear Model Analysis|||ED visits over 6 months||||0.63
71057954|NCT02374138|141621283|SUPERIORITY|||||||0.44||||||Adjusted for child age, gender, and baseline value|Generalized Linear Model Analysis|||ED Visits between 6 and 12 Month follow up||||0.44
71057955|NCT02374138|141621284|SUPERIORITY|||||||0.98||||||Adjusted for child age, gender, and baseline value|Generalized Linear Model Analysis|||Courses of systemic steroids over 6 months||||0.98
71057956|NCT02374138|141621284|SUPERIORITY|||||||0.48||||||Adjusted for child age, gender, and baseline value|Generalized Linear Model Analysis|||Courses of systemic steroids between 6m and 12m FU||||0.48
71025093|NCT02661126|141557338|OTHER|GMR of AUC0-last in Moderate RI/Healthy Participants.|GMR of AUC0-last in Moderate RI/Healthy|1.56|||||TWO_SIDED|90.0|1.19|2.05||||||||2.05|1.19|
71025094|NCT02661126|141557339|OTHER|GMR of AUC0-∞ in Moderate RI/Healthy Participants|GMR of AUC0-∞ in Moderate RI/Healthy|1.57|||||TWO_SIDED|90.0|1.2|2.05||||||||2.05|1.20|
71025095|NCT02661126|141557340|OTHER|GMR of AUC0-24 in Moderate RI/Healthy Participants|GMR of AUC0-24 in Moderate RI/Healthy|1.49|||||TWO_SIDED|90.0|1.13|1.98||||||||1.98|1.13|
71025096|NCT02661126|141557341|OTHER|GMR of Cmax in Moderate RI/Healthy Participants|GMR of Cmax in Moderate RI/Healthy|1.44|||||TWO_SIDED|90.0|1.05|1.98||||||||1.98|1.05|
71057957|NCT02374138|141621285|SUPERIORITY|||||||0.32||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 6 Month Follow Up||||0.32
71057958|NCT02374138|141621285|SUPERIORITY|||||||0.06||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 12 Month Follow Up||||0.06
71057959|NCT02374138|141621286|SUPERIORITY|||||||0.32||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 6 Month follow up||||0.32
71057960|NCT02374138|141621286|SUPERIORITY|||||||0.44||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 12 month follow up||||0.44
71057961|NCT02374138|141621287|SUPERIORITY|||||||0.7||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 6 Month Follow Up||||0.70
71057962|NCT02374138|141621287|SUPERIORITY|||||||0.8||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 12 Month Follow Up||||0.80
71057963|NCT02374138|141621288|SUPERIORITY|||||||0.53||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||6 Month Follow Up||||0.53
71057964|NCT02374138|141621288|SUPERIORITY|||||||0.77||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||12 Month Follow up||||0.77
71057965|NCT02374138|141621289|SUPERIORITY|||||||0.53||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||Quality of Life at 6 Month Follow up||||0.53
71057966|NCT02374138|141621289|SUPERIORITY|||||||0.57||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||Quality of Life at 12 Month Follow up||||0.57
71057967|NCT02374138|141621290|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71057968|NCT02374138|141621293|SUPERIORITY|||||||0.58||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||Score on Brief COPE at 12 Months||||0.58
71057969|NCT02374138|141621295|SUPERIORITY|||||||0.46||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||Score on LOT-R at 6 Month Follow Up||||0.46
71057970|NCT02374138|141621295|SUPERIORITY|||||||0.62||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||Score on LOT-R at 12 Month Follow Up||||0.62
71057971|NCT02374138|141621297|SUPERIORITY|By repeated measures, p-value adjusted for age and gender||||||0.35|||||||Generalized Linear Model Analysis|||||||0.35
71057972|NCT02374138|141621298|SUPERIORITY|Daytime asthma symptoms in prior 14d at 6-month follow up||||||0.54|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender||||||0.54
71108201|NCT02136914|141721840|SUPERIORITY||Least Squares Mean Difference|-7.9|STANDARD_ERROR_OF_MEAN|2.3||0.0009|TWO_SIDED|95.0|-12.5|-3.3|||Linear Mixed Model w/ Repeated Measures|Change from baseline is a dependent variable, treatment group is a factor, and the baseline value is a covariate.||46 subjects per treatment arm provided 90% power using a 2-sided test at 5% significance.||-3.3|-12.5|0.0009
71108202|NCT02136914|141721841|SUPERIORITY||Least Squares Mean Difference|-9.3|STANDARD_ERROR_OF_MEAN|2.7||0.0008|TWO_SIDED|95.0|-14.7|-4.0|||Linear Mixed Model w/ Repeated Measures|||||-4.0|-14.7|0.0008
70934842|NCT01638000|141370275|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.081||0.66|TWO_SIDED|95.0|-0.18|0.14||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From stratified rank ANCOVA analysis.||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.14|-0.18|0.66
71108203|NCT02136914|141721842|SUPERIORITY||Least Squares Mean Difference|2.74|STANDARD_ERROR_OF_MEAN|0.612|<|0.0001|TWO_SIDED|95.0|1.53|3.96||Change from Baseline in ON time without troublesome dyskinesia at Week 12.|Linear Mixed Model w/ Repeated Measures|||||3.96|1.53|<0.0001
71108204|NCT02136914|141721842|SUPERIORITY||Least Squares Mean Difference|2.22|STANDARD_ERROR_OF_MEAN|0.634||0.0007|TWO_SIDED|95.0|0.96|3.47||Change from Baseline in ON time without troublesome dyskinesia at Week 24.|Linear Mixed Model w/ Repeated Measures|||||3.47|0.96|0.0007
71108205|NCT02136914|141721842|SUPERIORITY||Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.373||0.0171|TWO_SIDED|95.0|-1.64|-0.16||Change from Baseline in OFF time at Week 12.|Linear Mixed Model w/ Repeated Measures|||||-0.16|-1.64|0.0171
71108206|NCT02136914|141721842|SUPERIORITY||Least Squares Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.389||0.0406|TWO_SIDED|95.0|-1.58|-0.04||Change from Baseline in OFF time at Week 24.|Linear Mixed Model w/ Repeated Measures|||||-0.04|-1.58|0.0406
71108207|NCT02136914|141721842|SUPERIORITY||Least Squares Mean Difference|-1.54|STANDARD_ERROR_OF_MEAN|0.508||0.0031|TWO_SIDED|95.0|-2.55|-0.53||Change from Baseline in ON time with troublesome dyskinesia at Week 12.|Linear Mixed Model w/ Repeated Measures|||||-0.53|-2.55|0.0031
71108208|NCT02136914|141721842|SUPERIORITY||Least Squares Mean Difference|-1.45|STANDARD_ERROR_OF_MEAN|0.526||0.0072|TWO_SIDED|95.0|-2.49|-0.4||Change from Baseline in ON time with troublesome dyskinesia at Week 24.|Linear Mixed Model w/ Repeated Measures|||||-0.40|-2.49|0.0072
70934843|NCT01638000|141370275|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.17|TWO_SIDED|95.0|-0.31|-0.03||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From the stratified rank ANCOVA analysis.||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||-0.03|-0.31|0.17
71108209|NCT02136914|141721843|SUPERIORITY||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.74||0.6833|TWO_SIDED|95.0|-6.6|4.3||Change from Baseline in MDS-UPDRS at Week 12.|Linear Mixed Model w/ Repeated Measures|||||4.3|-6.6|0.6833
71108210|NCT02136914|141721843|SUPERIORITY||Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|3.58||0.5557|TWO_SIDED|95.0|-5.0|9.2||Change from Baseline in MDS-UPDRS at Week 24.|Linear Mixed Model w/ Repeated Measures|||||9.2|-5.0|0.5557
71108211|NCT02136914|141721844|SUPERIORITY||||||<|0.0001||||||Baseline to Week 12|Cochran-Mantel-Haenszel|||||||<0.0001
71108212|NCT02136914|141721844|SUPERIORITY|||||||0.1071||||||Baseline to Week 24|Cochran-Mantel-Haenszel|||||||0.1071
71108213|NCT01247064|141721855|SUPERIORITY_OR_OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
70934844|NCT01638000|141370275|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.066||0.66|TWO_SIDED|95.0|-0.24|0.02||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From the stratified rank ANCOVA analysis.||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.02|-0.24|0.66
71108214|NCT01247064|141721856|SUPERIORITY_OR_OTHER|||||||0.86|||||||Chi-squared|||||||0.86
71108215|NCT01247064|141721857|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
71108216|NCT01247064|141721858|SUPERIORITY_OR_OTHER|||||||0.36|||||||t-test, 2 sided|||||||0.36
71108217|NCT01247064|141721859|SUPERIORITY_OR_OTHER|||||||0.62|||||||Chi-squared|||||||0.62
71108218|NCT00448448|141721876|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.93|||<|0.0267|TWO_SIDED|95.0|1.08|3.46|||Regression, Logistic|The success rate was adjusted for the propensity score (probability of receiving a brace) and the duration of follow-up.||||3.46|1.08|<0.0267
71108219|NCT04436744|141721963|SUPERIORITY|||||||0.0433|||||||t-test, 2 sided|||||||0.0433
71108220|NCT04436744|141721964|SUPERIORITY||Difference in Overall Response Rates|-0.93||||0.8272|TWO_SIDED|95.0|-14.66|12.81|||Cochran-Mantel-Haenszel|||ORR was calculated using the stratified Cochran-Mantel-Haenszel test.||12.81|-14.66|0.8272
71108221|NCT04436744|141721965|SUPERIORITY||Difference in Rate|6.86|||||TWO_SIDED|95.0|-4.25|17.97||||||||17.97|-4.25|
71108222|NCT01374425|141722016|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0555|TWO_SIDED|95.0|0.61|1.01||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||Hazard ratio (HR) (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by high/low excision repair cross-complementing (ERCC)-1 level and region of enrollment.||1.01|0.61|0.0555
71108223|NCT01374425|141722017|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.3944|TWO_SIDED|95.0|0.56|1.26||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.26|0.56|0.3944
71108224|NCT01374425|141722018|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.0786|TWO_SIDED|95.0|0.55|1.03||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.03|0.55|0.0786
71108225|NCT01374425|141722019|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.9576|TWO_SIDED|95.0|0.77|1.28||P-value (relative to ERCC-1 Low subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to ERCC-1 Low subgroup) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.28|0.77|0.9576
71108226|NCT01374425|141722020|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.1658|TWO_SIDED|95.0|0.93|1.53||P-value (relative to VEGF-A Low subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to VEGF-A Low subgroup) was estimated by Cox regression.|Analysis stratified by high/low ERCC-1 level and region of enrollment.||1.53|0.93|0.1658
71108227|NCT01374425|141722021|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.3019|TWO_SIDED|95.0|0.41|1.32||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.32|0.41|0.3019
71108228|NCT01374425|141722022|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.6035|TWO_SIDED|95.0|0.48|1.53||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.53|0.48|0.6035
71108229|NCT01374425|141722023|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.4032|TWO_SIDED|95.0|0.54|1.28||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.28|0.54|0.4032
71108230|NCT01374425|141722024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.0647|TWO_SIDED|95.0|0.41|1.03||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.03|0.41|0.0647
70941690|NCT04748445|141383934|OTHER||Slope|-0.07305|STANDARD_ERROR_OF_MEAN|4.267||0.0894|TWO_SIDED|90.0|-0.1438|-0.002335|||Mixed Models Analysis|||READ\_MFCC mean 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.002335|-0.1438|0.0894
71108231|NCT01374425|141722025|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.0861|TWO_SIDED|95.0|0.56|1.04||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by high/low ERCC-1 level and region of enrollment.||1.04|0.56|0.0861
71108232|NCT01374425|141722026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.3295|TWO_SIDED|95.0|0.51|1.26||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.26|0.51|0.3295
71108233|NCT01374425|141722027|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.1519|TWO_SIDED|95.0|0.49|1.12||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.12|0.49|0.1519
71108234|NCT01374425|141722028|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.2774|TWO_SIDED|95.0|0.87|1.62||P-value (relative to ERCC-1 Low subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to ERCC-1 Low subgroup) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.62|0.87|0.2774
71108235|NCT01374425|141722029|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|4.3|||||TWO_SIDED|95.0|-5.5|14.0|||||The difference was calculated as the percentage of participants with objective response in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||14.0|-5.5|
70851796|NCT00275340|141191632|NON_INFERIORITY_OR_EQUIVALENCE|Study was not powered to determine significant group differences; thus trends are reported for p\<0.20.|||||p<|0||95.0|||||t-test, 2 sided|||Mean change scores were computed on domain and summary scores. Mean differences in change scores between groups were computed and t-tests used to detect significant differences.||||p<0.20
71025097|NCT02661126|141557342|OTHER|GMR of C24 in Moderate RI/Healthy Participants|GMR of C24 in Moderate RI/Healthy|1.54|||||TWO_SIDED|90.0|1.15|2.07||||||||2.07|1.15|
70934845|NCT01638000|141370276|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.16||0.43|TWO_SIDED|95.0|-0.44|0.19||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.19|-0.44|0.43
71025098|NCT01151813|141557347|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||t-test, 2 sided|||||||.02
71025099|NCT01151813|141557348|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||t-test, 2 sided|||||||0.03
70851797|NCT00862641|141191645|SUPERIORITY_OR_OTHER|||||||0.1451||95.0|||||Cochran-Mantel-Haenszel|Analysis of treatment effect was based on the Cochran-Mantel Haenszel(CMH) test stratified by investigative site. Sites with \<15 subjects were pooled.||||||0.1451
70851798|NCT00862641|141191645|SUPERIORITY_OR_OTHER|||||||0.579||95.0|||||Cochran-Mantel-Haenszel|Analysis of treatment effect was based on the CMH test stratified by investigative site. Sites with less than 15 subjects were pooled.||||||0.5790
70851799|NCT00862641|141191648|SUPERIORITY_OR_OTHER|||||||0.0029||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.0029
70851800|NCT00862641|141191648|SUPERIORITY_OR_OTHER|||||||0.6189||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.6189
70851801|NCT00862641|141191649|SUPERIORITY_OR_OTHER|||||||0.0015||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.0015
70851802|NCT00862641|141191649|SUPERIORITY_OR_OTHER|||||||0.4385||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.4385
70851803|NCT00862641|141191650|SUPERIORITY_OR_OTHER|||||||0.0789||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.0789
70851804|NCT00862641|141191650|SUPERIORITY_OR_OTHER|||||||0.0258||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.0258
70851805|NCT00862641|141191651|SUPERIORITY_OR_OTHER|||||||0.2087||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.2087
70851806|NCT00862641|141191651|SUPERIORITY_OR_OTHER|||||||0.0289||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.0289
70851807|NCT00862641|141191652|SUPERIORITY_OR_OTHER|||||||0.9904||95.0|||||ANCOVA|||"P-value applies to 'Change at Hour 2'~P-value based on ranked analysis of covariance with treatment and investigator site as main effects and baseline value as a covariate in the model."||||0.9904
70851808|NCT00862641|141191652|SUPERIORITY_OR_OTHER|||||||0.8085||95.0|||||ANCOVA|||"P-value applies to 'Change at Hour 2'~P-value based on ranked analysis of covariance with treatment and investigator site as main effects and baseline value as a covariate in the model."||||0.8085
71025100|NCT01151813|141557349|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||t-test, 2 sided|||||||0.03
70851809|NCT02365480|141191656|OTHER||Odds Ratio (OR)|1.91||||0.6|TWO_SIDED|95.0|0.1|36.37|||Fisher Exact|||||36.37|0.10|0.60
70851810|NCT02791763|141191671|NON_INFERIORITY|Non-inferiority was to be established as the lower limit of the 95% confidence interval (CI) for the treatment difference was greater than the pre-specified non-inferiority margin (-1.0 g/dL).|Median Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.088|<|0.0001|TWO_SIDED|95.0|-0.07|0.28||The p value on this table is one-sided and calculated for the non-inferiority assessment.|Mixed model repeated measures (MMRM)||Analysis was performed by a MMRM with covariates of treatment, Baseline Hgb, visit, treatment-by-visit interaction and Baseline-by-visit interaction.|||0.28|-0.07|<.0001
70851811|NCT02791763|141191672|SUPERIORITY||Odds Ratio (OR)|1.01||||0.4941|TWO_SIDED|95.0|0.33|3.04||The p value on this table is one-sided and calculated for the superiority assessment.|Regression, Logistic||Analysis was performed by logistic regression with covariates of treatment, Baseline Hgb, and Baseline ESA use.|||3.04|0.33|0.4941
70851812|NCT02791763|141191673|SUPERIORITY||Odds Ratio (OR)|1.01||||0.4941|TWO_SIDED|95.0|0.33|3.04||The p value on this table is one-sided and calculated for the superiority assessment.|Regression, Logistic||Analysis was performed by logistic regression with covariates of treatment, Baseline Hgb, and Baseline ESA use.|||3.04|0.33|0.4941
71025101|NCT01151813|141557350|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|||||||t-test, 2 sided|||||||0.04
71025102|NCT02917447|141557355|SUPERIORITY|||||||0.15||||||Omnibus test for difference in change from baseline in PCL by treatment group across the three post-treatment assessments, adjusted for rural/urban status and MST.|Mixed Models Analysis|Fixed effects were study assessment, group, the assessment by group interaction, and covariates. Participant was modeled as a random effect.||||||0.15
71057973|NCT02374138|141621298|SUPERIORITY|Daytime Asthma Symptoms at 12 month follow up||||||0.11|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender||||||0.11
71057974|NCT02374138|141621298|SUPERIORITY|Days of Activity Limitations at 6 month follow up||||||0.82|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender||||||0.82
71057975|NCT02374138|141621298|SUPERIORITY|Days of Activity Limitations at 12 month follow up||||||0.84|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender||||||0.84
71057976|NCT02374138|141621298|SUPERIORITY|Days of Quick Relief Medicine Use at 6 month follow up||||||0.7|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender||||||0.70
71057977|NCT02374138|141621298|SUPERIORITY|Days of Quick Relief Medicine Use at 12 month follow up||||||0.58|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender||||||0.58
71057978|NCT02374138|141621299|OTHER|Univariate test||||||0.2|||||||Chi-squared|||Parent education||||0.20
71057979|NCT02374138|141621300|SUPERIORITY|||||||0.91||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||ETS exposure at 6 Month Follow Up||||0.91
71057980|NCT02374138|141621300|SUPERIORITY|||||||0.98||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||ETS Exposure at 12 Month Follow up||||0.98
71057981|NCT02374138|141621301|OTHER|Univariate test||||||0.94|||||||Chi-squared|||||||0.94
71057982|NCT02374138|141621302|SUPERIORITY|||||||0.02||||||p-value adjusted for age and gender|Generalized Linear Model Analysis|||Parent use of mental health resources at 6 Months||||0.02
71057983|NCT02374138|141621302|SUPERIORITY|||||||0.85||||||p-value adjusted for age and gender|Generalized Linear Model Analysis|||Parent use of mental health resources at 12 Months||||0.85
71057984|NCT02374138|141621303|OTHER|Univariate test||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.90
71108236|NCT01374425|141722030|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|9.4|||||TWO_SIDED|95.0|7.2|26.1|||||The difference was calculated as the percentage of participants with objective response in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||26.1|7.2|
71108237|NCT01374425|141722031|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|2.1|||||TWO_SIDED|95.0|-9.9|14.1|||||The difference was calculated as the percentage of participants with objective response in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||14.1|-9.9|
71108238|NCT01374425|141722032|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|-3.7|||||TWO_SIDED|95.0|-14.0|6.6|||||The difference was calculated as the percentage of participants with objective response in the ERCC-1 High subgroup minus the ERCC-1 Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||6.6|-14.0|
71108239|NCT01374425|141722033|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|2.1|||||TWO_SIDED|95.0|-7.6|3.3|||||The difference was calculated as the percentage of participants with disease control in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||3.3|-7.6|
71108240|NCT01374425|141722034|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|-8.7|||||TWO_SIDED|95.0|-19.1|1.7|||||The difference was calculated as the percentage of participants with disease control in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||1.7|-19.1|
71108241|NCT01374425|141722035|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|2.3|||||TWO_SIDED|95.0|-3.7|8.3|||||The difference was calculated as the percentage of participants with disease control in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||8.3|-3.7|
71108242|NCT01374425|141722036|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|-4.5|||||TWO_SIDED|95.0|-10.6|1.5|||||The difference was calculated as the percentage of participants with disease control in the ERCC-1 High subgroup minus the ERCC-1 Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||1.5|-10.6|
71108243|NCT01374425|141722037|SUPERIORITY_OR_OTHER||Difference in Resection Rates|-4.0|||||TWO_SIDED|95.0|-15.9|7.8|||||The difference was calculated as the percentage of participants with resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||7.8|-15.9|
71108244|NCT01374425|141722038|SUPERIORITY_OR_OTHER||Difference in Complete Resection Rates|-6.5|||||TWO_SIDED|95.0|-16.3|3.3|||||The difference was calculated as the percentage of participants with complete resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||3.3|-16.3|
71025103|NCT02917447|141557356|SUPERIORITY|||||||0.049||||||Omnibus test for difference in change from baseline in outcome by treatment group across the three post-treatment assessments, adjusted for rural/urban status and MST.|Mixed Models Analysis|Fixed effects were study assessment, group, the assessment by group interaction, and covariates. Participant was modeled as a random effect.||||||.049
71108245|NCT01374425|141722039|SUPERIORITY_OR_OTHER||Difference in Resection Rates|-11.0|||||TWO_SIDED|95.0|-33.1|11.1|||||The difference was calculated as the percentage of participants with resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||11.1|-33.1|
71108246|NCT01374425|141722040|SUPERIORITY_OR_OTHER||Difference in Complete Resection Rates|-11.0|||||TWO_SIDED|95.0|-33.1|11.1|||||The difference was calculated as the percentage of participants with complete resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||11.1|-33.1|
71108247|NCT01374425|141722041|SUPERIORITY_OR_OTHER||Difference in Resection Rates|-3.0|||||TWO_SIDED|95.0|-10.1|4.2|||||The difference was calculated as the percentage of participants with resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||4.2|-10.1|
71108248|NCT01374425|141722042|SUPERIORITY_OR_OTHER||Difference in Complete Resection Rates|-5.5|||||TWO_SIDED|95.0|-11.5|0.4|||||The difference was calculated as the percentage of participants with complete resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||0.4|-11.5|
71025104|NCT02917447|141557357|SUPERIORITY|||||||0.92||||||Omnibus test for difference in change from baseline in outcome by treatment group across the three post-treatment assessments, adjusted for rural/urban status and MST.|Mixed Models Analysis|Fixed effects were study assessment, group, the assessment by group interaction, and covariates. Participant was modeled as a random effect.||||||0.92
71108249|NCT01374425|141722043|SUPERIORITY_OR_OTHER||Difference in Resection Rates|-4.4|||||TWO_SIDED|95.0|-9.5|0.6|||||The difference was calculated as the percentage of participants with resection in the ERCC-1 High subgroup minus the ERCC-1 Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||0.6|-9.5|
71108250|NCT01374425|141722044|SUPERIORITY_OR_OTHER||Difference in Complete Resection Rates|-1.6|||||TWO_SIDED|95.0|-6.2|3.1|||||The difference was calculated as the percentage of participants with complete resection in the ERCC-1 High subgroup minus the ERCC-1 Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||3.1|-6.2|
71108251|NCT01374425|141722045|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.0593|TWO_SIDED|95.0|0.99|1.69||P-value (relative to KRAS Wild-Type subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to KRAS Wild-Type subgroup) was estimated by Cox regression.|Analysis stratified by high/low ERCC-1 level and region of enrollment.||1.69|0.99|0.0593
71108252|NCT01374425|141722046|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.64||||0.002|TWO_SIDED|95.0|1.2|2.24||P-value (relative to VEGF-A Low subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to VEGF-A Low subgroup) was estimated by Cox regression.|Analysis stratified by high/low ERCC-1 level and region of enrollment.||2.24|1.20|0.0020
70851813|NCT01419197|141191774|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.528|||<|0.0001|TWO_SIDED|95.0|0.422|0.661||The two-sided stratified log-rank test was used to compare progression-free survival between the two treatment arms at the overall two-sided significance level of 0.5%.|Log Rank||The hazard ratio was estimated by Cox regression.|The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or \> 3); and 3) Presence of visceral disease (any visceral disease vs no visceral disease).||0.661|0.422|<0.0001
70934846|NCT01638000|141370276|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.157||0.027|TWO_SIDED|95.0|-0.66|-0.04||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||-0.04|-0.66|0.027
70934847|NCT01638000|141370276|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.164||0.053|TWO_SIDED|95.0|-0.64|0.0|||ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.00|-0.64|0.053
71057985|NCT04386616|141621319|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9266|TWO_SIDED|95.0|0.75|1.36||p\<0.05 threshold for statistical significance|Unstratified Log Rank||The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.36|0.75|0.9266
70941691|NCT04748445|141383934|OTHER||Slope|-2.369|STANDARD_ERROR_OF_MEAN|4.428||0.5936|TWO_SIDED|90.0|-9.706|4.968|||Mixed Models Analysis|||READ\_MFCC mean 09 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||4.968|-9.706|0.5936
71057986|NCT04386616|141621319|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.357|TWO_SIDED|95.0|0.86|1.54||p\<0.05 threshold for statistical significance|Unstratified Log Rank||The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.54|0.86|0.3570
71057987|NCT04386616|141621319|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9812|TWO_SIDED|95.0|0.74|1.36||p\<0.05 threshold for statistical significance|Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.36|0.74|0.9812
71057988|NCT04386616|141621319|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.5151|TWO_SIDED|95.0|0.82|1.49||p\<0.05 threshold for statistical significance|Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.49|0.82|0.5151
71057989|NCT04386616|141621320|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.8373|TWO_SIDED|95.0|0.77|1.39|||Unstratified Log Rank||The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.39|0.77|0.8373
71057990|NCT04386616|141621320|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.3396|TWO_SIDED|95.0|0.86|1.55|||Unstratified Log Rank||The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.55|0.86|0.3396
71057991|NCT04386616|141621320|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.8619|TWO_SIDED|95.0|0.76|1.39|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.39|0.76|0.8619
71057992|NCT04386616|141621320|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.4913|TWO_SIDED|95.0|0.82|1.5|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.50|0.82|0.4913
71057993|NCT04386616|141621321|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.4711|TWO_SIDED|95.0|0.83|1.49|||Unstratified Log Rank||The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.49|0.83|0.4711
71057994|NCT04386616|141621321|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.3135|TWO_SIDED|95.0|0.87|1.56|||Unstratified Log Rank||The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.56|0.87|0.3135
71057995|NCT04386616|141621321|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.5735|TWO_SIDED|95.0|0.81|1.48|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.48|0.81|0.5735
71057996|NCT04386616|141621321|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.5973|TWO_SIDED|95.0|0.8|1.46|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.46|0.80|0.5973
71057997|NCT04386616|141621322|SUPERIORITY||Median Difference (Net)|-1.0||||0.5304|||||||Van Elteren||The median difference was calculated as the MSTT1041A Arm minus the Placebo Arm.|||||0.5304
71057998|NCT04386616|141621322|SUPERIORITY||Median Difference (Net)|-4.5||||0.5058|||||||Van Elteren||The median difference was calculated as the UTT1147A Arm minus the Placebo Arm.|||||0.5058
71057999|NCT04386616|141621323|SUPERIORITY||Odds Ratio (OR)|1.05||||0.8451|TWO_SIDED|95.0|0.64|1.72|||Chi-squared||The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.72|0.64|0.8451
71058000|NCT04386616|141621323|SUPERIORITY||Odds Ratio (OR)|1.09||||0.7267|TWO_SIDED|95.0|0.67|1.79|||Chi-squared||The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.79|0.67|0.7267
71058001|NCT04386616|141621323|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8458|TWO_SIDED|95.0|0.63|1.79|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.79|0.63|0.8458
71058002|NCT04386616|141621323|SUPERIORITY||Odds Ratio (OR)|1.08||||0.7907|TWO_SIDED|95.0|0.64|1.81|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.81|0.64|0.7907
71108253|NCT01374425|141722047|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.34||||0.0955|TWO_SIDED|95.0|0.95|1.88||P-value (relative to KRAS Wild-Type subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to KRAS Wild-Type subgroup) was estimated by Cox regression.|Analysis stratified by high/low ERCC-1 level and region of enrollment.||1.88|0.95|0.0955
71108254|NCT01374425|141722048|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|-5.9|||||TWO_SIDED|95.0|-15.7|3.8|||||The difference was calculated as the percentage of participants with objective response in the VEGF-A High subgroup minus the VEGF-A Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||3.8|-15.7|
71058003|NCT04386616|141621324|SUPERIORITY||Median Difference (Final Values)|0.0||||0.5273|||||||Van Elteren||The median difference was calculated as the MSTT1041A Arm minus the Placebo Arm.|||||0.5273
71058004|NCT04386616|141621324|SUPERIORITY||Median Difference (Final Values)|0.0||||0.6515|||||||Van Elteren||The median difference was calculated as the UTT1147A Arm minus the Placebo Arm.|||||0.6515
70851814|NCT01419197|141191775|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.552||||0.0034|TWO_SIDED|95.0|0.369|0.826||The 2-sided stratified log-rank test was used at the overall two-sided significance level of 4.5%. The pre-specified O'Brien-Fleming stopping boundary for this first OS interim analysis was HR\<0.363 (p-value \< 0.0000013).|Log Rank||The hazard ratio was estimated by Cox regression.|The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or \> 3); and 3) Presence of visceral disease (any visceral disease vs no visceral disease).||0.826|0.369|0.0034
70851815|NCT01419197|141191776|SUPERIORITY_OR_OTHER||Difference in Response Percentage|22.7|||<|0.0001|TWO_SIDED|95.0|16.2|29.2|||Mantel Haenszel|||The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or \> 3); and 3) Presence of visceral disease (any visceral disease vs no visceral disease).||29.2|16.2|<0.0001
70851816|NCT01419197|141191778|SUPERIORITY_OR_OTHER||Difference in Survival Percentage|12.6||||0.0011|TWO_SIDED|95.0|5.03|20.09||The p-value for the difference in survival rate was derived from the z-test using the standard errors computed using Greenwood's method.|z-test|||6-month survival||20.09|5.03|0.0011
70851817|NCT01419197|141191778|SUPERIORITY_OR_OTHER||Difference in Survival Percentage|11.7||||0.1805|TWO_SIDED|95.0|-5.41|28.75||The p-value for the difference in survival rates was derived from the z-test using the standard errors computed using Greenwood's method.|z-test|||1-year survival||28.75|-5.41|0.1805
70851818|NCT01419197|141191779|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.115||||0.4952|TWO_SIDED|95.0|0.819|1.517|||Log Rank|||The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or \> 3); and 3) Presence of visceral disease (any visceral disease vs no visceral disease).||1.517|0.819|0.4952
70851819|NCT01419197|141191781|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.677||||0.0007|TWO_SIDED|95.0|0.539|0.85||The two-sided stratified log-rank test was used at the overall two-sided significance level of 4.5%. The pre-specified O'Brien-Fleming stopping boundary for this second and final interim analysis was HR\<0.748 (p value \< 0.012).|Log Rank||The hazard ratio was estimated by Cox regression.|The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or \> 3); and 3) Presence of visceral disease (any visceral disease versus no visceral disease).||0.850|0.539|0.0007
70851820|NCT01419197|141191782|SUPERIORITY_OR_OTHER||Difference in Survival Percentage|12.4||||0.0003|TWO_SIDED|95.0|5.67|19.14||The p-value for the difference in survival rate was derived from the z-test using the standard errors computed using Greenwood's method.|z-test|||6-month survival||19.14|5.67|0.0003
70851821|NCT01419197|141191782|SUPERIORITY_OR_OTHER||Difference in Survival Percentage|11.0||||0.0104|TWO_SIDED|95.0|2.58|19.33||The p-value for the difference in survival rates was derived from the z-test using the standard errors computed using Greenwood's method.|z-test|||1-year survival||19.33|2.58|0.0104
70851822|NCT02428478|141191798|OTHER|||||||0.01||||||P\<0.05 considered statistically significant|Wilcoxon Matched-Pairs Signed-Rank Test|||Tonic analysis||||0.01
70851823|NCT02428478|141191798|OTHER|||||||0.38||||||P\<0.05 considered statistically significant|Wilcoxon Matched-Pairs Signed-Rank Test|||Phasic analysis||||0.38
70851824|NCT02428478|141191799|OTHER||Median Change|-0.6||||0.037|TWO_SIDED||||||Wilcoxon Matched-Pairs Signed-Rank Test|||Passive Pcrit||||0.037
70851825|NCT02428478|141191799|OTHER||||||>|0.5|||||||Wilcoxon Matched-Pairs Signed-Rank Test|||Active Pcrit||||>0.5
70851826|NCT02663934|141191800|SUPERIORITY||Mean Difference (Net)|0.15||||0.31|TWO_SIDED|95.0|0.05|0.25|||ANOVA|||||.25|.05|0.31
70851827|NCT02663934|141191801|SUPERIORITY||Mean Difference (Net)|1.42||||0.24|TWO_SIDED||||||ANOVA|||Change in Global CBF in EXS vs. SIS||||.24
70851828|NCT02663934|141191801|OTHER||Slope|0.41||||0.02|ONE_SIDED|95.0|||||Regression, Linear|||Change in Strength \& Change in Frontal Brain Volume in EXS||||.02
70851829|NCT02663934|141191801|OTHER||Slope|0.4||||0.02|ONE_SIDED|95.0|||||Regression, Linear|||Changes in Brain Volumes associated with changes Memory Performance in EXS||||0.02
71058005|NCT04386616|141621324|SUPERIORITY||Odds Ratio (OR)|1.16||||0.5475|TWO_SIDED|95.0|0.71|1.91|||Proportional Odds Model|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.91|0.71|0.5475
71058006|NCT04386616|141621324|SUPERIORITY||Odds Ratio (OR)|1.16||||0.5652|TWO_SIDED|95.0|0.71|1.89|||Proportional Odds Model|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.89|0.71|0.5652
71058007|NCT04386616|141621325|SUPERIORITY||Median Difference (Final Values)|0.0||||0.3401|||||||Van Elteren||The median difference was calculated as the MSTT1041A Arm minus the Placebo Arm.|||||0.3401
71058008|NCT04386616|141621325|SUPERIORITY||Median Difference (Final Values)|0.0||||0.4676|||||||Van Elteren||The median difference was calculated as the UTT1147A Arm minus the Placebo Arm.|||||0.4676
70851830|NCT02663934|141191802|OTHER||Slope|0.47||||0.005|ONE_SIDED|95.0|||||Regression, Linear|||Increases in Time Spent in MVPA and Increased Learning Performance in EXS||||.005
70851831|NCT02878798|141191803|OTHER|Non-inferiority and superiority tests were completed|Slope|0.2105|||||ONE_SIDED|95.0|-0.4328||||||||||-0.4328|
70934848|NCT01638000|141370276|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.163||0.16|TWO_SIDED|95.0|-0.55|0.09||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Final Visit Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.09|-0.55|0.16
71058009|NCT04386616|141621325|SUPERIORITY||Odds Ratio (OR)|1.31||||0.3408|TWO_SIDED|95.0|0.75|2.29|||Proportional Odds Model|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.29|0.75|0.3408
71058010|NCT04386616|141621325|SUPERIORITY||Odds Ratio (OR)|1.32||||0.332|TWO_SIDED|95.0|0.76|2.29|||Proportional Odds Model|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||2.29|0.76|0.3320
71058011|NCT04386616|141621326|SUPERIORITY||Difference in percentage of participants|3.83|||||TWO_SIDED|95.0|-7.57|15.24|||||The difference in percentage of participants was calculated as the MSTT1041A Arm minus the Placebo Arm.|||15.24|-7.57|
71058012|NCT04386616|141621326|SUPERIORITY||Difference in percentage of participants|-0.38|||||TWO_SIDED|95.0|-11.46|10.7|||||The difference in percentage of participants was calculated as the UTTR1147A Arm minus the Placebo Arm.|||10.70|-11.46|
71058013|NCT04386616|141621326|SUPERIORITY||Odds Ratio (OR)|1.22||||0.4804|TWO_SIDED|95.0|0.7|2.1|||Chi-squared||The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.10|0.70|0.4804
71058014|NCT04386616|141621326|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9418|TWO_SIDED|95.0|0.56|1.71|||Chi-squared||The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.71|0.56|0.9418
70851832|NCT02878798|141191804|OTHER|Non-inferiority and superiority tests were done|Slope|-1.5219|||||ONE_SIDED|95.0||1.1933||||||||1.1933||
70851833|NCT02878798|141191805|SUPERIORITY||Slope|-0.02322|||||TWO_SIDED|95.0|-0.6337|0.5872|||Mixed Models Analysis|||||0.5872|-0.6337|
70851834|NCT02878798|141191806|SUPERIORITY||Slope|-0.168||||0.261|TWO_SIDED|95.0|-0.4612|0.1253|||Mixed Models Analysis|||||0.1253|-0.4612|0.261
71058015|NCT04386616|141621326|SUPERIORITY||Odds Ratio (OR)|1.29||||0.4988|TWO_SIDED|95.0|0.68|2.44|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.44|0.68|0.4988
71058016|NCT04386616|141621326|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9043|TWO_SIDED|95.0|0.54|1.96|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.96|0.54|0.9043
71058017|NCT04386616|141621327|SUPERIORITY||Median Difference (Net)|0.0||||0.8007|||||||Van Elteren||Median difference was calculated as the MSTT1041A Arm minus the Placebo Arm.|||||0.8007
71058018|NCT04386616|141621327|SUPERIORITY||Median Difference (Net)|0.0||||0.8633|||||||Van Elteren||Median difference was calculated as the UTTR1147A Arm minus the Placebo Arm.|||||0.8633
71058019|NCT04386616|141621328|SUPERIORITY||Difference in percentage of participants|-3.59|||||TWO_SIDED|95.0|-16.31|9.12|||||The difference in percentage of participants was calculated as the MSTT1041A Arm minus the Placebo Arm.|||9.12|-16.31|
71058020|NCT04386616|141621328|SUPERIORITY||Difference in percentage of participants|-12.0|||||TWO_SIDED|95.0|-24.67|0.67|||||The difference in percentage of participants was calculated as the UTTR1147A Arm minus the Placebo Arm.|||0.67|-24.67|
71058021|NCT04386616|141621328|SUPERIORITY||Odds Ratio (OR)|0.86||||0.556|TWO_SIDED|95.0|0.53|1.41|||Chi-squared||The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.41|0.53|0.5560
71058022|NCT04386616|141621328|SUPERIORITY||Odds Ratio (OR)|0.62||||0.0502|TWO_SIDED|95.0|0.38|1.0|||Chi-squared||The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.00|0.38|0.0502
71058023|NCT04386616|141621328|SUPERIORITY||Odds Ratio (OR)|0.91||||0.7002|TWO_SIDED|95.0|0.51|1.6|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.60|0.51|0.7002
71058024|NCT04386616|141621328|SUPERIORITY||Odds Ratio (OR)|0.57||||0.0448|TWO_SIDED|95.0|0.32|0.99|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||0.99|0.32|0.0448
71058025|NCT04386616|141621329|SUPERIORITY||Median Difference (Net)|-0.48||||0.4845|||||||Van Elteren||Median difference was calculated as the MSTT1041A Arm minus the Placebo Arm.|||||0.4845
71058026|NCT04386616|141621329|SUPERIORITY||Median Difference (Net)|-3.1||||0.057|||||||Van Elteren||Median difference was calculated as the UTTR1147A Arm minus the Placebo Arm.|||||0.0570
71058027|NCT04386616|141621330|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.4456|TWO_SIDED|95.0|0.76|1.88|||Unstratified Log Rank||The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.88|0.76|0.4456
71058028|NCT04386616|141621330|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.7213|TWO_SIDED|95.0|0.57|1.48|||Unstratified Log Rank||The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.48|0.57|0.7213
71108255|NCT01374425|141722049|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|-5.4|||||TWO_SIDED|95.0|-16.0|5.2|||||The difference was calculated as the percentage of participants with objective response in the KRAS Mutant subgroup minus the KRAS Wild-Type subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||5.2|-16.0|
71108256|NCT01374425|141722050|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|-1.1|||||TWO_SIDED|95.0|-6.5|4.3|||||The difference was calculated as the percentage of participants with disease control in the VEGF-A High subgroup minus the VEGF-A Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||4.3|-6.5|
71108257|NCT01374425|141722051|SUPERIORITY_OR_OTHER||Difference in Resection Rates|-3.2|||||TWO_SIDED|95.0|-8.6|2.1|||||The difference was calculated as the percentage of participants with resection in the VEGF-A High subgroup minus the VEGF-A Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||2.1|-8.6|
71108258|NCT01374425|141722052|SUPERIORITY_OR_OTHER||Difference in Complete Resection Rates|-4.9|||||TWO_SIDED|95.0|-9.6|-0.2|||||The difference was calculated as the percentage of participants with complete resection in the VEGF-A High subgroup minus the VEGF-A Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||-0.2|-9.6|
71108259|NCT01227057|141722084|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were based on the SI-R using effect size estimates from a previous trial comparing individual CBT with a Wait List (WL) control (Steketee2010). In this study, the effect size of Cognitive Behavioral Therapy (CBT) relative to WL was d = 2.21 on the SI-R. Accounting for a smaller effect size due to having an active control condition, we expected to have 80% power to detect a large (d = .80) effect size. The sample assessed for eligibility (n = 67) was 99% of this target.||||||0.029||||||P value is for the group x time interaction.|Mixed Models Analysis|Adjusted for age, years of education, and presence of co-morbid obsessive-compulsive disorder due to group differences at baseline.||Linear mixed models with random intercepts were used to evaluate the change in primary and secondary outcome variables over time, the effect of group, the effect of treatment, and the treatment group by time interaction, both for the treatment phase (0-6 months) and follow up phase (6-12 months). All analyses (0-6 months) were conducted first using observed data only (i.e., completer analysis) and then using an intent to treat (ITT) sample.||||.029
71108260|NCT01227057|141722085|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were based on the SI-R using effect size estimates from a previous trial comparing individual CBT with a Wait List (WL) control (Steketee2010). In this study, the effect size of Cognitive Behavioral Therapy (CBT) relative to WL was d = 2.21 on the SI-R. Accounting for a smaller effect size due to having an active control condition, we expected to have 80% power to detect a large (d = .80) effect size. The sample assessed for eligibility (n = 67) was 99% of this target.||||||0.04||||||P value is for the group x time interaction.|Mixed Models Analysis|Adjusted for age, years of education, and presence of co-morbid obsessive-compulsive disorder due to group differences at baseline.||Linear mixed models with random intercepts were used to evaluate the change in primary and secondary outcome variables over time, the effect of group, the effect of treatment, and the treatment group by time interaction, both for the treatment phase (0-6 months) and follow up phase (6-12 months). All analyses (0-6 months) were conducted first using observed data only (i.e., completer analysis) and then using an intent to treat (ITT) sample.||||.04
71108261|NCT01227057|141722086|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were based on the SI-R using effect size estimates from a previous trial comparing individual CBT with a Wait List (WL) control (Steketee2010). In this study, the effect size of Cognitive Behavioral Therapy (CBT) relative to WL was d = 2.21 on the SI-R. Accounting for a smaller effect size due to having an active control condition, we expected to have 80% power to detect a large (d = .80) effect size. The sample assessed for eligibility (n = 67) was 99% of this target.|||||>|0.1||||||P value is for the group x time interaction.|ANOVA|||||||>.1
70934849|NCT01638000|141370277|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.023||0.99|TWO_SIDED|95.0|-0.05|0.05||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.05|-0.05|0.99
70934850|NCT01638000|141370277|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.027||0.47|TWO_SIDED|95.0|-0.07|0.03||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.03|-0.07|0.47
70934851|NCT01638000|141370277|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.032||0.99|TWO_SIDED|95.0|-0.06|0.06||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.06|-0.06|0.99
70934852|NCT01638000|141370277|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.031||0.74|TWO_SIDED|95.0|-0.05|0.07||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Final visit Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.07|-0.05|0.74
71108262|NCT01240863|141722087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.134|TWO_SIDED|95.0|-0.11|0.82||statistical significance level of 0.05.|ANCOVA|Treatment and stratification (opioid naïve/opioid experienced) factors as the fixed effects; screening and baseline APIs as covariates.|placebo - hydrocodone|||0.82|-0.11|0.134
71108263|NCT01419119|141722113|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
71108264|NCT01419119|141722114|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
71108265|NCT03768427|141722117|OTHER|Difference in least squares mean|Mean Difference (Final Values)|-19.5|||<|0.001|TWO_SIDED|95.0|-26.7|-12.3|||Constrained longitudinal model|||"This statistical analysis was performed by fitting a constrained longitudinal model adjusting for time and the interaction of time by treatment, and time by baseline disease risk category, including all participants with baseline data (88 participants in arm Atorvastatin 10 mg - ezetimibe 10 mg/Ator 10 mg and 89 participants in arm Atorvastatin 10mg - Atorvastatin 20 mg)."|Difference in least squares mean is Atorvastatin 10 mg - EZ 10 mg/Ator 10 mg minus Atorvastatin 10mg - Atorvastatin 20 mg.|-12.3|-26.7|<0.001
71108266|NCT03768427|141722117|OTHER|Difference in least squares mean|Mean Difference (Final Values)|-15.9|||<|0.001|TWO_SIDED|95.0|-21.0|-10.7|||Constrained longitudinal model|||"This statistical analysis was performed by fitting a constrained longitudinal model adjusting for time and the interaction of time by treatment, and time by baseline disease risk category, including all participants with baseline data (137 participants in arm Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg and 140 participants in arm Atorvastatin 20 mg - Atorvastatin 40 mg)."|Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg minus Atorvastatin 20 mg - Atorvastatin 40 mg.|-10.7|-21.0|<0.001
71108267|NCT00776789|141722121|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4
71108268|NCT00776789|141722122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0||95.0|1.4|4.3|||Wilcoxon (Mann-Whitney)|||Exclusive breast feeding at 48 hours was 95% (19 out of 20 partcipants were exclusively breast feeding)in the skin-to-skin contact group vs. 38.1% in the control group||4.3|1.4|0.00
70934853|NCT01638000|141370278|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.03||||0.67|TWO_SIDED|95.0|0.89|1.2||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 4 Rate Ratio vs. Mirabegron||1.20|0.89|0.67
71108269|NCT00776789|141722123|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.001||95.0|1.6|6.3|||Wilcoxon (Mann-Whitney)|||||6.3|1.6|0.001
71108270|NCT02742129|141722124|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|-0.2||||0.265|TWO_SIDED|95.0|-0.56|0.16|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||0.16|-0.56|0.2650
71108271|NCT02742129|141722125|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis|Mean Difference (Final Values)|-14.68||||0.9069|TWO_SIDED|95.0|-263.65|234.29|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data||234.29|-263.65|0.9069
71108272|NCT02742129|141722126|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|0.05||||0.9338|TWO_SIDED|95.0|-1.16|1.27|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||1.27|-1.16|0.9338
70851835|NCT02878798|141191807|SUPERIORITY||Slope|-0.061||||0.9007|TWO_SIDED|95.0|-1.0213|0.8992|||Mixed Models Analysis|||||0.8992|-1.0213|0.9007
70851836|NCT02878798|141191808|SUPERIORITY||Slope|0.0106||||0.8174|TWO_SIDED|95.0|-0.0793|0.1005|||Hurdle model|||||0.1005|-0.0793|0.8174
71108273|NCT02742129|141722127|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|-0.29||||0.8151|TWO_SIDED|95.0|-2.79|2.2|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||2.20|-2.79|0.8151
71108274|NCT02742129|141722128|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|0.82||||0.4658|TWO_SIDED|95.0|-1.41|3.05|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||3.05|-1.41|0.4658
71108275|NCT02742129|141722129|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|1.06||||0.3902|TWO_SIDED|95.0|-1.37|3.49|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||3.49|-1.37|0.3902
71108276|NCT02742129|141722130|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|10.69||||0.7404|TWO_SIDED|95.0|-53.21|74.6|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||74.6|-53.21|0.7404
71108277|NCT02742129|141722131|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Median Difference (Final Values)|0.05||||0.4282|TWO_SIDED|95.0|-0.08|0.18|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||0.18|-0.08|0.4282
71108278|NCT02742129|141722133|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|-0.49||||0.1067|TWO_SIDED|95.0|-1.08|0.11|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||0.11|-1.08|0.1067
71108279|NCT02742129|141722134|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|-0.1||||0.4411|TWO_SIDED|95.0|-0.37|0.16|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||0.16|-0.37|0.4411
71108280|NCT02629861|141722142|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
71108281|NCT02629861|141722142|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
71108282|NCT02629861|141722144|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 1 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||<0.0001
71108283|NCT02629861|141722144|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 1 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||<0.0001
71108284|NCT02629861|141722144|SUPERIORITY|||||||0.0032||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 2 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||0.0032
71108285|NCT02629861|141722144|SUPERIORITY|||||||0.001||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 2 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||0.0010
70851837|NCT02878798|141191809|SUPERIORITY||Slope|-0.7394||||0.0233|TWO_SIDED|95.0|-1.3775|-0.1013|||Mixed Models Analysis|||||-0.1013|-1.3775|0.0233
70851838|NCT02878798|141191810|SUPERIORITY||Slope|-0.1328||||0.7586|TWO_SIDED|95.0|-0.982|0.7164|||Mixed Models Analysis|||||0.7164|-0.982|0.7586
71108286|NCT02629861|141722144|SUPERIORITY|||||||0.0048||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 3 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||0.0048
71108287|NCT02629861|141722144|SUPERIORITY|||||||0.0003||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 3 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||0.0003
71108288|NCT02629861|141722144|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Overall P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||<0.0001
71108289|NCT02629861|141722144|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Overall P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||<0.0001
71108290|NCT02629861|141722145|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint||||<0.0001
71108291|NCT02629861|141722145|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint||||<0.0001
71025105|NCT01144663|141557362|NON_INFERIORITY|Indication of non-inferiority of Nimenrix 3 Group compared to Menjugate Group is a lower limit of the 95% CI of the group difference greater than or equal to the predefined clinical limits of -5%.|Difference in percentage|0.01|||||TWO_SIDED|95.0|-1.17|1.2||||||To demonstrate the non-inferiority of the Nimenrix 3 Group compared to the Menjugate Group, two-sided standardized asymptotic 95% CI (confidence interval) for the groups difference \[Nimenrix 3 Group minus Menjugate Group\] in the percentages of subjects with bactericidal vaccine response to MenC was computed.||1.2|-1.17|
70851839|NCT02878798|141191811|SUPERIORITY||Slope|-0.0021||||0.9604|TWO_SIDED|95.0|-0.084|0.0799|||Mixed Models Analysis|||||0.0799|-0.084|0.9604
70851840|NCT02878798|141191812|SUPERIORITY||Slope|-0.0396||||0.2365|TWO_SIDED|95.0|-0.1053|0.0261|||Mixed Models Analysis|||||0.0261|-0.1053|0.2365
70851841|NCT02878798|141191813|SUPERIORITY||Slope|2.3848||||0.5813|TWO_SIDED|95.0|-6.1336|10.9032|||Mixed Models Analysis|||||10.9032|-6.1336|0.5813
70851842|NCT02878798|141191814|SUPERIORITY||Slope|-1.0547||||0.4092|TWO_SIDED|95.0|-3.5705|1.4611|||Mixed Models Analysis|||||1.4611|-3.5705|0.4092
70851843|NCT01510769|141191824|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1||||0.1298|TWO_SIDED|95.0|-0.03|0.23|||Cochran-Mantel-Haenszel|||||0.23|-0.03|0.1298
70851844|NCT01510769|141191824|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.29|||<|0.0001|TWO_SIDED|95.0|0.17|0.42|||Cochran-Mantel-Haenszel|||||0.42|0.17|<0.0001
70851845|NCT01510769|141191825|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.04||||0.4453|TWO_SIDED|95.0|-0.07|0.16|||Cochran-Mantel-Haenszel|||||0.16|-0.07|0.4453
70851846|NCT01510769|141191825|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.09||||0.1149|TWO_SIDED|95.0|-0.02|0.21|||Cochran-Mantel-Haenszel|||||0.21|-0.02|0.1149
70851847|NCT01510769|141191826|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.03||||0.645|TWO_SIDED|95.0|-0.1|0.17|||Cochran-Mantel-Haenszel|||||0.17|-0.10|0.6450
70851848|NCT01510769|141191826|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.06||||0.4118|TWO_SIDED|95.0|-0.08|0.19|||Cochran-Mantel-Haenszel|||||0.19|-0.08|0.4118
70851849|NCT01510769|141191827|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.08||||0.3034|TWO_SIDED|95.0|-0.24|0.07|||Cochran-Mantel-Haenszel|||||0.07|-0.24|0.3034
70851850|NCT01510769|141191827|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.19||||0.021|TWO_SIDED|95.0|-0.34|-0.04|||Cochran-Mantel-Haenszel|||||-0.04|-0.34|0.0210
70851851|NCT01980485|141191854|NON_INFERIORITY_OR_EQUIVALENCE|This study had 87% power to detect a 40% increase in 28-dayabstinence rates (i.e., from 50% to 70%) based on a two-tailed chi-squared test and alpha = 0.05. We selected this effect size as being at the lower end of the effect size continuum that would be clinically meaningful at 28 days and have the potential to still be meaningful in the longer term even with similar relapse rates in both groups over subsequent months.||||||0.65|||||||Chi-squared|||||||.65
71058029|NCT04386616|141621330|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.3963|TWO_SIDED|95.0|0.77|1.96|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.96|0.77|0.3963
70851852|NCT00744042|141191858|SUPERIORITY_OR_OTHER|||||||0.0039|TWO_SIDED|||||Testing whether median change in rickets severity from Baseline to Week 24, measured by RGI-C at Week 24, is from zero.|Wilcoxon signed-rank test|The last post-baseline observation carry forward method is used; patients with no post-baseline assessments were imputed as having no change.||One treatment group||||0.0039
70851853|NCT00750152|141191862|SUPERIORITY_OR_OTHER||one-sided p-value from CMH test|0.001||||0.025|ONE_SIDED|95.0|||||Cochran-Mantel-Haenszel|The CMH test after stratification by site compared the proportion of complete cure in NAFT-500 to that of placebo to evaluate its superiority.||"In order to compare complete cure rate in the NAFT-500 group with that in the placebo group, the following one-sided null and alternate hypotheses will be tested:~* H0: p1 \<= p0~* Ha: p1 \> p0 where p0 and p1 denote the proportion of subjects with complete cure in the placebo and NAFT-500 groups, respectively."||||0.025
70851854|NCT02140593|141191874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71058030|NCT04386616|141621330|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.9174|TWO_SIDED|95.0|0.6|1.58|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.58|0.60|0.9174
71058031|NCT04386616|141621331|OTHER||Difference in Mortality Rates|2.49|||||TWO_SIDED|95.0|-4.51|9.49|||||The difference in mortality rates is calculated as the MSTT1041A Arm minus the Placebo Arm.|||9.49|-4.51|
71058032|NCT04386616|141621331|OTHER||Difference in Mortality Rates|2.36|||||TWO_SIDED|95.0|-4.58|9.31|||||The difference in mortality rates is calculated as the UTTR1147A Arm minus the Placebo Arm.|||9.31|-4.58|
71058033|NCT04386616|141621331|SUPERIORITY||Odds Ratio (OR)|1.46||||0.4336|TWO_SIDED|95.0|0.57|3.74|||Chi-squared||The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||3.74|0.57|0.4336
71058034|NCT04386616|141621331|SUPERIORITY||Odds Ratio (OR)|1.43||||0.4543|TWO_SIDED|95.0|0.56|3.68|||Chi-squared||The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||3.68|0.56|0.4543
71058035|NCT04386616|141621331|SUPERIORITY||Odds Ratio (OR)|1.46||||0.49|TWO_SIDED|95.0|0.54|3.97|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||3.97|0.54|0.4900
71058036|NCT04386616|141621331|SUPERIORITY||Odds Ratio (OR)|1.58||||0.3595|TWO_SIDED|95.0|0.58|4.28|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||4.28|0.58|0.3595
71058037|NCT04386616|141621332|OTHER||Difference in Mortality Rates|3.42|||||TWO_SIDED|95.0|-5.42|12.26|||||The difference in mortality rates is calculated as the MSTT1041A Arm minus the Placebo Arm.|||12.26|-5.42|
71058038|NCT04386616|141621332|OTHER||Difference in Mortality Rates|1.68|||||TWO_SIDED|95.0|-6.89|10.26|||||The difference in mortality rates is calculated as the UTTR1147A Arm minus the Placebo Arm.|||10.26|-6.89|
71058039|NCT04386616|141621332|SUPERIORITY||Odds Ratio (OR)|1.36||||0.4067|TWO_SIDED|95.0|0.66|2.8|||Chi-squared||The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.80|0.66|0.4067
71058040|NCT04386616|141621332|SUPERIORITY||Odds Ratio (OR)|1.17||||0.6728|TWO_SIDED|95.0|0.56|2.46|||Chi-squared||The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||2.46|0.56|0.6728
71025106|NCT01144663|141557362|NON_INFERIORITY|Indication of non-inferiority of Nimenrix 3 Group compared to Menjugate Group is a lower limit of the 95% CI of the group difference greater than or equal to the predefined clinical limits of -5%.|Difference in percenttage|-0.43|||||TWO_SIDED|95.0|-1.57|0.4||||||To demonstrate the non-inferiority of the Nimenrix 3 Group compared to the NeisVac-C Group, two-sided standardized asymptotic 95% CI for the groups difference \[Nimenrix 3 Group minus NeisVac-C Group\] in the percentages of subjects with bactericidal vaccine response to MenC was computed.||0.4|-1.57|
71058041|NCT04386616|141621332|SUPERIORITY||Odds Ratio (OR)|1.33||||0.5495|TWO_SIDED|95.0|0.62|2.87|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.87|0.62|0.5495
70851855|NCT02140593|141191875|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70934854|NCT01638000|141370278|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.17||||0.073|TWO_SIDED|95.0|0.99|1.39||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 8 Rate Ratio vs. Mirabegron||1.39|0.99|0.073
70934855|NCT01638000|141370278|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.12||||0.25|TWO_SIDED|95.0|0.92|1.37||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 12 Rate Ratio vs. Mirabegron||1.37|0.92|0.25
71025107|NCT01144663|141557362|NON_INFERIORITY|Indication of non-inferiority of Nimenrix 3 Group compared to Menjugate Group is a lower limit of the 95% CI of the group difference greater than or equal to the predefined clinical limits of -5%.|Difference in percentage|-0.88|||||TWO_SIDED|95.0|-2.45|0.43||||||To demonstrate the non-inferiority of the Nimenrix 2 Group compared to Menjugate Group, two-sided standardized asymptotic 95% CI for the groups difference \[Nimenrix 2 Group minus Menjugate Group\] in the percentages of subjects with bactericidal vaccine response to MenC was computed.||0.43|-2.45|
71025108|NCT01144663|141557362|NON_INFERIORITY|Indication of non-inferiority of Nimenrix 3 Group compared to Menjugate Group is a lower limit of the 95% CI of the group difference greater than or equal to the predefined clinical limits of -5%.|Difference in percentage|-1.32|||||TWO_SIDED|95.0|-2.84|-0.48||||||To demonstrate the non-inferiority of the Nimenrix 2 Group compared to NeisVac-C Group, two-sided standardized asymptotic 95% CI for the groups difference \[Nimenrix 2 Group minus NeisVac-C Group\] in the percentages of subjects with bactericidal vaccine response to MenC was computed.||-0.48|-2.84|
71025109|NCT03081767|141557410|OTHER||||||<|1e-07||||||Actual P-Value = 3.89597E-42. A P-value of \<0.05 was considered significant.|t-test, 2 sided|||||||<0.0000001
71025110|NCT01335477|141557411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|93.73|STANDARD_ERROR_OF_MEAN|24.907||0.0002||95.0|44.78|142.68||The objective of this trial was to assess the superiority of nintedanib 150 mg bid compared to placebo on the annual rate of decline in FVC.|Random coefficient regression|The Roger-Kenward approximation was used to estimate denominators degrees of freedom.|"Within-patient errors are modelled by an Unstructured variance-covariance matrix.~Inter-individual variability is modelled by a Variance-components variance-covariance matrix.~Nintedanib 150 mg bid versus Placebo."|"Random coefficient regression with fixed effects for treatment, gender, age, height and random effect of patient specific intercept and time.~A hierarchical procedure was used in order to demonstrate the superiority of nintedanib over placebo for one primary and two key secondary endpoints.~The consecutive steps of the hierarchy were only considered if the previous step was significant at the one-sided 2.5% level and the results were in favour of nintedanib."||142.68|44.78|0.0002
71025111|NCT01335477|141557412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|1.151||0.0197||95.0|-4.95|-0.43|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Total score, baseline SGRQ Total score-by-visit and random effect for patient.||-0.43|-4.95|0.0197
71025112|NCT01335477|141557413|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.38||||0.005||95.0|0.19|0.77|||Log Rank||Nintedanib 150 mg bid versus Placebo.|Hazard Ratio is based on a Cox's regression model with terms for treatment, gender, age and height.||0.77|0.19|0.0050
71025113|NCT01335477|141557414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|109.77|STANDARD_ERROR_OF_MEAN|19.808|<|0.0001||95.0|70.92|148.62|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC, baseline FVC-by-visit and random effect for patient.||148.62|70.92|<0.0001
71025114|NCT01335477|141557415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.24|STANDARD_ERROR_OF_MEAN|0.742|<|0.0001||95.0|2.78|5.69|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC, baseline FVC-by-visit and random effect for patient.||5.69|2.78|<0.0001
71025115|NCT01335477|141557416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.06|STANDARD_ERROR_OF_MEAN|0.607|<|0.0001||95.0|1.87|4.25|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC \[%predicted\], baseline FVC \[%predicted\]-by-visit and random effect for patient.||4.25|1.87|<0.0001
71108292|NCT02629861|141722146|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint||||<0.0001
71108293|NCT02629861|141722146|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint||||<0.0001
71108294|NCT02629861|141722147|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint.||||<0.0001
71108295|NCT02629861|141722147|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint.||||<0.0001
71108296|NCT02629861|141722148|SUPERIORITY|||||||0.0023||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint.||||0.0023
71108297|NCT02629861|141722148|SUPERIORITY|||||||0.0021||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint.||||0.0021
71108298|NCT01685684|141722156|SUPERIORITY_OR_OTHER_LEGACY||Marginal Mean Difference (Net)|-1.56|STANDARD_ERROR_OF_MEAN|0.267|<|0.0001|TWO_SIDED||||||z-test|||||||<0.0001
71108299|NCT00902330|141722170|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Spearman correlation coefficients were computed for the biomarkers. P-Values shown are not adjusted for multiple comparisons. The a priori threshold for statistical significance was P less than 0.05. This information applies to all rows listed in the table.||||<0.05
71108300|NCT04290624|141722209|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.4|-0.2|||ANCOVA|||||-0.20|-0.40|<0.0001
71108301|NCT04290624|141722210|SUPERIORITY||Mean Difference (Final Values)|-28.6|STANDARD_ERROR_OF_MEAN|4.73|<|0.0001|TWO_SIDED|95.0|-38.1|-19.1|||ANCOVA|||At Week 6||-19.1|-38.1|<0.0001
71108302|NCT04290624|141722210|SUPERIORITY||Mean Difference (Final Values)|-27.9|STANDARD_ERROR_OF_MEAN|5.08|<|0.0001|TWO_SIDED|95.0|-38.2|-17.7|||ANCOVA|||At Week 12||-17.7|-38.2|<0.0001
71108303|NCT04290624|141722211|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001|TWO_SIDED|95.0|-0.52|-0.27|||ANCOVA|||At Week 6||-0.27|-0.52|<0.0001
70934856|NCT01638000|141370278|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.08||||0.4|TWO_SIDED|95.0|0.9|1.31||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Final Visit Rate Ratio vs. Mirabegron||1.31|0.90|0.40
70941692|NCT04748445|141383934|OTHER||Slope|-0.07377|STANDARD_ERROR_OF_MEAN|3.339||0.029|TWO_SIDED|90.0|-0.1291|-0.01844|||Mixed Models Analysis|||READ\_MFCC mean 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.01844|-0.1291|0.0290
71108304|NCT04290624|141722211|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.054|<|0.0001|TWO_SIDED|95.0|-0.47|-0.25|||ANCOVA|||At Week 12||-0.25|-0.47|<0.0001
71108305|NCT04290624|141722212|SUPERIORITY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.142|<|0.0001|TWO_SIDED|95.0|-1.14|-0.56|||ANCOVA|||At Week 6||-0.56|-1.14|<0.0001
71108306|NCT04290624|141722212|SUPERIORITY||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.139|<|0.0001|TWO_SIDED|95.0|-1.23|-0.67|||ANCOVA|||At Week 12||-0.67|-1.23|<0.0001
71108307|NCT04290624|141722213|SUPERIORITY||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.151|<|0.0001|TWO_SIDED|95.0|-1.22|-0.61|||ANCOVA|||At Week 6||-0.61|-1.22|<0.0001
71108308|NCT04290624|141722213|SUPERIORITY||Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.154|<|0.0001|TWO_SIDED|95.0|-1.36|-0.74|||ANCOVA|||At Week 12||-0.74|-1.36|<0.0001
71108309|NCT04290624|141722214|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|-0.41|-0.23|||ANCOVA|||||-0.23|-0.41|<0.0001
71108310|NCT04290624|141722215|SUPERIORITY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.0039|TWO_SIDED|95.0|-0.9|-0.2|||ANCOVA|||At Week 6||-0.2|-0.9|0.0039
71108311|NCT04290624|141722215|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.1|-0.5|||ANCOVA|||At Week 12||-0.5|-1.1|<0.0001
71108312|NCT04290624|141722216|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.05||0.0367|TWO_SIDED|95.0|-0.21|-0.01|||ANCOVA|||At Week 6||-0.01|-0.21|0.0367
71108313|NCT04290624|141722216|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.033||0.0725|TWO_SIDED|95.0|-0.14|-0.01|||Van-Elteren test|||At Week 12||-0.01|-0.14|0.0725
71108314|NCT04290624|141722217|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.075||0.0006|TWO_SIDED|95.0|-0.43|-0.13|||ANCOVA|||At Week 6||-0.13|-0.43|0.0006
71108315|NCT04290624|141722217|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.073||0.0009|TWO_SIDED|95.0|-0.41|-0.11|||ANCOVA|||At Week 12||-0.11|-0.41|0.0009
71108316|NCT04290624|141722218|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.117||0.002|TWO_SIDED|95.0|-0.62|-0.15|||ANCOVA|||At Week 6||-0.15|-0.62|0.0020
71108317|NCT04290624|141722218|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.09||0.0005|TWO_SIDED|95.0|-0.52|-0.16|||ANCOVA|||At Week 12||-0.16|-0.52|0.0005
71117627|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
71025116|NCT01335477|141557417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.21|STANDARD_ERROR_OF_MEAN|0.743|<|0.0001||95.0|2.76|5.67|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC \[%predicted\], baseline FVC \[%predicted\]-by-visit and random effect for patient.||5.67|2.76|<0.0001
71025117|NCT01335477|141557420|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.286||||0.1833||95.0|0.89|1.86|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, age, gender, height and baseline FVC % predicted||1.86|0.89|0.1833
71108318|NCT00956384|141722223|SUPERIORITY|A minimally clinically important difference of 4 as statistically significant at the 0.05 level (two-sided), with a power equal to 0.85.|Mean Difference (Final Values)|-2.69||||0.05|TWO_SIDED|95.0|-10.57|5.19||Threshold for statistical significance was p= 0.05|t-test, 2 sided|||For the comparison of mean BREAST-Q subdomain score at each timepoint, Mann-Whitney U test was used for skewed data, while independent t-test was used for not skewed data. We investigated the possibly variable effects of the treatment group differences across multiple time-points, namely 2 weeks after mastectomy, at 6 months and at 12 months following the reconstruction procedure. A linear regression model was used to account for the correlation between the three time-points within each patient||5.19|-10.57|0.05
71108319|NCT00956384|141722224|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Regression, Logistic|||We assessed the effect of the surgical method on the occurrences of any complications versus none via logistic regression, and results were expressed as odds ratios with 95% CIs.||||<0.05
71108320|NCT00656370|141722229|SUPERIORITY|||||||0.93|||||||Wilcoxon signed rank test|||||||0.93
71108321|NCT00656370|141722230|SUPERIORITY|||||||0.67|||||||Wilcoxon signed rank test|||||||0.67
71108322|NCT01147302|141722242|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|8.89||||0.6498|TWO_SIDED|95.0|-24.65|42.42||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of C4d score||42.42|-24.65|0.6498
71058042|NCT04386616|141621332|SUPERIORITY||Odds Ratio (OR)|1.24||||0.5551|TWO_SIDED|95.0|0.57|2.71|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||2.71|0.57|0.5551
71058043|NCT04386616|141621333|SUPERIORITY||Hazard Ratio (HR)|1.31||||0.3831|TWO_SIDED|95.0|0.71|2.4|||Unstratified Log Rank||The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.40|0.71|0.3831
70941693|NCT04748445|141383934|OTHER||Slope|0.008703|STANDARD_ERROR_OF_MEAN|3.665||0.8127|TWO_SIDED|90.0|-0.05203|0.06944|||Mixed Models Analysis|||READ\_MFCC mean 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.06944|-0.05203|0.8127
71025118|NCT01335477|141557421|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.794||||0.0011||95.0|1.26|2.55|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, age, gender, height and baseline FVC % predicted.||2.55|1.26|0.0011
71058044|NCT04386616|141621333|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.5925|TWO_SIDED|95.0|0.65|2.15|||Unstratified Log Rank||The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||2.15|0.65|0.5925
71058045|NCT04386616|141621333|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.7487|TWO_SIDED|95.0|0.6|2.05|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.05|0.60|0.7487
71058046|NCT04386616|141621333|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.6092|TWO_SIDED|95.0|0.63|2.21|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||2.21|0.63|0.6092
71058047|NCT01377012|141621344|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21||||0.0004|TWO_SIDED|95.0|1.4|3.4|||Regression, Logistic|||||3.4|1.4|0.0004
71108323|NCT01147302|141722242|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|18.56||||0.0768|TWO_SIDED|95.0|1.43|35.68||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of margination score||35.68|1.43|0.0768
71108324|NCT01147302|141722242|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|-4.0||||0.6928|TWO_SIDED|95.0|-21.36|13.36||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of glomerulitis score||13.36|-21.36|0.6928
71108325|NCT01147302|141722242|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|7.11||||0.0508|TWO_SIDED|95.0|1.23|12.99||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of vasculitis score||12.99|1.23|0.0508
71025119|NCT01335477|141557422|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.664||||0.0218||95.0|1.08|2.57|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, baseline SGRQ total score||2.57|1.08|0.0218
71025120|NCT01335477|141557423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.675||0.4019||95.0|-4.69|1.88|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Symptoms component, baseline SGRQ Symptoms component-by-visit and random effect for patient.||1.88|-4.69|0.4019
71025121|NCT01335477|141557424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.08|STANDARD_ERROR_OF_MEAN|1.342||0.022||95.0|-5.71|-0.45|||Mixed Models Analysis||"Within-patient error are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ impact component, baseline SGRQ impact component-by-visit and random effect for patient||-0.45|-5.71|0.0220
71025122|NCT01335477|141557425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.31|STANDARD_ERROR_OF_MEAN|1.36||0.0152||95.0|-5.97|-0.64|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Activities component, baseline SGRQ Activities component-by-visit and random effect for patient||-0.64|-5.97|0.0152
71025123|NCT01335477|141557426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.12|STANDARD_ERROR_OF_MEAN|1.192||0.0089||95.0|-5.46|-0.79|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ-I Total score, baseline SGRQ-I Total score-by-visit and random effect for patient.||-0.79|-5.46|0.0089
71108326|NCT01147302|141722242|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|-4.89||||0.2042|TWO_SIDED|95.0|-11.34|1.56||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of glomerulosclerosis score||1.56|-11.34|0.2042
71108327|NCT01147302|141722242|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|-0.22||||0.3322|TWO_SIDED|95.0|-0.61|0.17||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of chronic glomerulopathy score||0.17|-0.61|0.3322
71025124|NCT01335477|141557427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.38|STANDARD_ERROR_OF_MEAN|1.685||0.1587||95.0|-5.68|0.93|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SOBQ score, baseline SOBQ score-by-visit and random effect for patient.||0.93|-5.68|0.1587
71025125|NCT01335477|141557428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.05|STANDARD_ERROR_OF_MEAN|1.713||0.2326||95.0|-1.31|5.41|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline CASA-Q Cough symptoms score, baseline CASA-Q Cough symptoms score-by-visit and random effect for patient.||5.41|-1.31|0.2326
71025126|NCT01335477|141557429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81|STANDARD_ERROR_OF_MEAN|1.564||0.2475||95.0|-1.26|4.88|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline CASA-Q Cough impact score, baseline CASA-Q Cough impact score-by-visit and random effect for patient.||4.88|-1.26|0.2475
71025127|NCT01335477|141557430|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.379||||0.069||95.0|0.98|1.95|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with term treatment||1.95|0.98|0.0690
71025128|NCT01335477|141557432|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.38||||0.007||95.0|0.19|0.77|||Normal distribution|Risk ratio was calculated as the ratio of risk of exacerbation in both treatment groups.|Nintedanib 150 mg bid versus Placebo|The log of the risk ratio was assumed to follow a normal distribution with mean 0 and variance equal to the sum of the reciprocals of the number of patients with at least one exacerbation in each treatment arm.||0.77|0.19|0.0070
71025129|NCT01335477|141557433|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.2995||95.0|0.4|1.35|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard ratio is based on a Cox´s regression model with terms for treatment, gender, age and height.||1.35|0.40|0.2995
71025130|NCT01335477|141557434|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.6654||95.0|0.39|1.9|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height.||1.90|0.39|0.6654
71025131|NCT01335477|141557435|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.2209||95.0|0.34|1.35|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard ratio is based on a Cox´s regression model with terms for treatment, gender, age and height.||1.35|0.34|0.2209
71025132|NCT01335477|141557436|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.1664||95.0|0.37|1.21|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height.||1.21|0.37|0.1664
71025133|NCT01335477|141557437|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.2123||95.0|0.55|1.16|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height.||1.16|0.55|0.2123
71025134|NCT01335477|141557438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.213||0.2032||95.0|-0.15|0.69|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline SpO2, baseline SpO2-by-visit and random effect for patient.||0.69|-0.15|0.2032
71108328|NCT01147302|141722242|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|5.67||||0.4723|TWO_SIDED|95.0|-7.77|9.11||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of interstitial fibrosis score||9.11|-7.77|0.4723
70941694|NCT04748445|141383934|OTHER||Slope|-0.07414|STANDARD_ERROR_OF_MEAN|3.294||0.0262|TWO_SIDED|90.0|-0.1287|-0.01955|||Mixed Models Analysis|||READ\_MFCC mean 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.01955|-0.1287|0.0262
71058048|NCT01377012|141621344|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21||||0.0004|TWO_SIDED|95.0|1.4|3.4|||Regression, Logistic|||||3.4|1.4|0.0004
71058049|NCT00993421|141621394|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||<0.001
71058050|NCT00993421|141621394|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||<0.001
71058051|NCT00993421|141621394|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||<0.001
71058052|NCT00993421|141621394|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||<0.001
71058053|NCT00993421|141621394|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||0.041
70934857|NCT01638000|141370279|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.115||0.84|TWO_SIDED|95.0|-0.25|0.2||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.20|-0.25|0.84
70934858|NCT01638000|141370279|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.099||0.63|TWO_SIDED|95.0|-0.24|0.15||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.15|-0.24|0.63
70934859|NCT01638000|141370279|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.111||0.59|TWO_SIDED|95.0|-0.28|0.16||if p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.16|-0.28|0.59
71058054|NCT00993421|141621394|SUPERIORITY_OR_OTHER|||||||0.668||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||0.668
70934860|NCT01638000|141370280|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.05||||0.068|TWO_SIDED|95.0|1.0|1.11||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 4 Rate Ratio vs. Mirabegron||1.11|1.00|0.068
70934861|NCT01638000|141370280|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.04||||0.21|TWO_SIDED|95.0|0.98|1.11||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 8 Rate Ratio vs. Mirabegron||1.11|0.98|0.21
70941695|NCT04748445|141383934|OTHER||Slope|2.929|STANDARD_ERROR_OF_MEAN|2.705||0.2809|TWO_SIDED|90.0|-1.553|7.412|||Mixed Models Analysis|||READ\_MFCC mean 13 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||7.412|-1.553|0.2809
71058055|NCT00993421|141621394|SUPERIORITY_OR_OTHER|||||||0.437||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||0.437
71058056|NCT00993421|141621394|SUPERIORITY_OR_OTHER|||||||0.249||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||0.249
71058057|NCT03736031|141621416|SUPERIORITY|||||||0.09|||||||two-sample independent t-test|An alpha of 0.05 was used.||||||0.09
71058058|NCT03736031|141621417|SUPERIORITY|||||||0.81|||||||two-sample independent t-test|An alpha of 0.05 was used.||||||0.81
71058059|NCT03736031|141621418|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||||||0.33
71058060|NCT03736031|141621419|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71058061|NCT00352417|141621433|SUPERIORITY_OR_OTHER|||||||0.97|||||||t-test, 2 sided|Satterthwaite's method||||||0.97
71058062|NCT00352417|141621434|SUPERIORITY_OR_OTHER|||||||0.37|||||||t-test, 2 sided|Satterthwaite's method||||||0.37
71058063|NCT00352417|141621435|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71058064|NCT00352417|141621436|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANCOVA|ANCOVA was performed on the natural log transformed data||||||<0.01
71058065|NCT00352417|141621437|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
71058066|NCT02555254|141621450|SUPERIORITY|||||||0.55|||||||Wilcoxon's rank test|||||||0.55
71058067|NCT06075277|141621458|OTHER||Ratios of adjusted geometric means [%]|126.64|||||TWO_SIDED|90.0|112.09|143.08|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 19.8|Relative bioavailability of Zongertinib administered in fed state (Test) compared with Zongertinib administered in fasted state (Reference) was estimated by the ratios of the gMeans (Test/Reference). Their corresponding 2-sided 90% confidence intervals (CIs) were provided. This method corresponds to 2 one-sided t-test procedures, each at the 5% significance level.||143.08|112.09|
71058068|NCT06075277|141621459|OTHER||Ratios of adjusted geometric means [%]|126.12|||||TWO_SIDED|90.0|106.34|149.58|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 27.9.|Relative bioavailability of Zongertinib administered in fed state (Test) compared with Zongertinib administered in fasted state (Reference) was estimated by the ratios of the gMeans (Test/Reference). Their corresponding 2-sided 90% confidence intervals (CIs) were provided. This method corresponds to 2 one-sided t-test procedures, each at the 5% significance level.||149.58|106.34|
71058069|NCT06075277|141621460|OTHER||Ratios of adjusted geometric means [%]|126.04|||||TWO_SIDED|90.0|111.7|142.21|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 19.6.|Relative bioavailability of Zongertinib administered in fed state (Test) compared with Zongertinib administered in fasted state (Reference) was estimated by the ratios of the gMeans (Test/Reference). Their corresponding 2-sided 90% confidence intervals (CIs) were provided. This method corresponds to 2 one-sided t-test procedures, each at the 5% significance level.||142.21|111.70|
70934862|NCT01638000|141370280|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.02||||0.52|TWO_SIDED|95.0|0.95|1.1||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 12 Rate Ratio vs. Mirabegron||1.10|0.95|0.52
71058070|NCT03975491|141621463|SUPERIORITY||Mean Difference (Net)|20.9||||0.32|TWO_SIDED|95.0|-17.1|76.2|||Mixed Models Analysis||From a model that included the baseline value of the dependent variable and sex (randomization stratification factor) as covariates.|||76.2|-17.1|0.32
70941696|NCT04748445|141383934|OTHER||Slope|-2.717|STANDARD_ERROR_OF_MEAN|6.612|<|0.0001|TWO_SIDED|90.0|-3.812|-1.621|||Mixed Models Analysis|||READ\_MFCC std 01 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and estimated value it was 10\^-1. For dispersion value it was 10\^-2).||-1.621|-3.812|<.0001
71058071|NCT03975491|141621464|SUPERIORITY||Mean Difference (Net)|11.4||||0.25|TWO_SIDED|95.0|-7.5|34.0|||Mixed Models Analysis||From a model that included the baseline value of the dependent variable and sex (randomization stratification factor) as covariates.|||34.0|-7.5|0.25
71058072|NCT03975491|141621465|SUPERIORITY||Mean Difference (Net)|-3.6||||0.52|TWO_SIDED|95.0|-13.7|7.7|||Mixed Models Analysis||From a model that included the baseline value of the dependent variable and sex (randomization stratification factor) as covariates.|||7.7|-13.7|0.52
71058073|NCT03975491|141621466|SUPERIORITY||Mean Difference (Net)|0.59||||0.21|TWO_SIDED|95.0|-0.33|1.51|||Mixed Models Analysis||From a model that included the baseline value of the dependent variable and sex (randomization stratification factor) as covariates.|||1.51|-0.33|0.21
71058074|NCT03975491|141621468|SUPERIORITY||Mean Difference (Net)|0.0005||||0.73|TWO_SIDED|95.0|-0.0024|0.0034|||Mixed Models Analysis||From a model that included the baseline value of the dependent variable and sex (randomization stratification factor) as covariates.|||0.0034|-0.0024|0.73
71058075|NCT02260570|141621518|SUPERIORITY||F value|24.1|||<|0.0001|TWO_SIDED|||||This p-value is adjusted for multiple comparisons.|ANOVA|F(1,1,60) = 24.1, p \< 0.0001, adjusted r\^2 = 0.275||||||<0.0001
71058076|NCT02260570|141621519|SUPERIORITY||F value|6.23||||0.0184|TWO_SIDED|||||This p-value is adjusted for multiple comparisons.|ANOVA|F(1,30) = 6.23, p = 0.0184, adjusted r\^2 = 0.144||||||0.0184
71058077|NCT05026177|141621520|SUPERIORITY||Mean Difference (Final Values)|0.45||||0.5335|TWO_SIDED|95.0|-0.96|1.86|||Mixed Models Analysis|||||1.86|-0.96|0.5335
71058078|NCT05026177|141621520|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.5836|TWO_SIDED|95.0|-0.99|1.76|||Mixed Models Analysis|||||1.76|-0.99|0.5836
71058079|NCT05026177|141621521|SUPERIORITY||Mean Difference (Final Values)|-1.57||||0.0763|TWO_SIDED|95.0|-3.3|0.17|||Mixed Models Analysis|||||0.17|-3.30|0.0763
71058080|NCT05026177|141621521|SUPERIORITY||Mean Difference (Final Values)|-1.24||||0.153|TWO_SIDED|95.0|-2.93|0.46|||Mixed Models Analysis|||||0.46|-2.93|0.1530
71058081|NCT04856917|141621533|SUPERIORITY||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|3.21||0.3757|TWO_SIDED|90.0|-2.47|8.19|||LRMM|||Least square (LS) Mean, SE, 90% CI, \& p-value was based on a linear repeated measures model (LRMM) which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.||8.19|-2.47|0.3757
71058082|NCT04856917|141621533|SUPERIORITY||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|3.22||0.6183|TWO_SIDED|90.0|-3.73|6.95|||LRMM|||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.||6.95|-3.73|0.6183
71058083|NCT04856917|141621534|SUPERIORITY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.7||0.249|TWO_SIDED|90.0|-0.85|4.8||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||4.80|-0.85|0.2490
71058084|NCT04856917|141621534|SUPERIORITY||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|1.72||0.0708|TWO_SIDED|90.0|0.28|5.99||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||5.99|0.28|0.0708
71058085|NCT04856917|141621534|SUPERIORITY||LS Mean Difference|7.9|STANDARD_ERROR_OF_MEAN|2.68||0.004|TWO_SIDED|90.0|3.44|12.34||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||12.34|3.44|0.0040
71058086|NCT04856917|141621534|SUPERIORITY||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|2.71||0.206|TWO_SIDED|90.0|-1.05|7.94||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||7.94|-1.05|0.2060
71058087|NCT04856917|141621534|SUPERIORITY||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|2.66||0.4341|TWO_SIDED|90.0|-2.33|6.51||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||6.51|-2.33|0.4341
71058088|NCT04856917|141621534|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|2.73||0.7307|TWO_SIDED|90.0|-3.59|5.48||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||5.48|-3.59|0.7307
71058089|NCT04856917|141621534|SUPERIORITY||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|2.93||0.3261|TWO_SIDED|90.0|-1.97|7.77||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||7.77|-1.97|0.3261
71058090|NCT04856917|141621534|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.95||0.8221|TWO_SIDED|90.0|-5.56|4.23||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||4.23|-5.56|0.8221
71058091|NCT04856917|141621535|SUPERIORITY||LS Mean Difference|6.4|STANDARD_ERROR_OF_MEAN|6.2||0.3008|TWO_SIDED|90.0|-3.84|16.73||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||16.73|-3.84|0.3008
71058092|NCT04856917|141621535|SUPERIORITY||LS Mean Difference|10.8|STANDARD_ERROR_OF_MEAN|6.27||0.0878|TWO_SIDED|90.0|0.4|21.19||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||21.19|0.40|0.0878
71058093|NCT04856917|141621535|SUPERIORITY||LS Mean Difference|26.6|STANDARD_ERROR_OF_MEAN|8.42||0.002|TWO_SIDED|90.0|12.64|40.57||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||40.57|12.64|0.0020
71058094|NCT04856917|141621535|SUPERIORITY||LS Mean Difference|14.0|STANDARD_ERROR_OF_MEAN|8.5||0.1029|TWO_SIDED|90.0|-0.12|28.09||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||28.09|-0.12|0.1029
71058095|NCT04856917|141621535|SUPERIORITY||LS Mean Difference|5.4|STANDARD_ERROR_OF_MEAN|8.82||0.5427|TWO_SIDED|90.0|-9.25|20.02||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||20.02|-9.25|0.5427
71058096|NCT04856917|141621535|SUPERIORITY||LS Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|9.06||0.5833|TWO_SIDED|90.0|-10.05|20.02||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||20.02|-10.05|0.5833
71058097|NCT04856917|141621535|SUPERIORITY||LS Mean Difference|10.8|STANDARD_ERROR_OF_MEAN|10.98||0.3293|TWO_SIDED|90.0|-7.46|28.99||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||28.99|-7.46|0.3293
71058098|NCT04856917|141621535|SUPERIORITY||LS Mean Difference|14.5|STANDARD_ERROR_OF_MEAN|10.99||0.19|TWO_SIDED|90.0|-3.74|32.74||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||32.74|-3.74|0.1900
70941697|NCT04748445|141383934|OTHER||Slope|-0.05798|STANDARD_ERROR_OF_MEAN|2.961||0.0524|TWO_SIDED|90.0|-0.107|-0.008915|||Mixed Models Analysis|||READ\_MFCC std 02 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.008915|-0.1070|0.0524
71058099|NCT04856917|141621535|SUPERIORITY||LS Mean Difference|11.7|STANDARD_ERROR_OF_MEAN|9.38||0.2168|TWO_SIDED|90.0|-3.91|27.23||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||27.23|-3.91|0.2168
71058100|NCT04856917|141621535|SUPERIORITY||LS Mean Difference|7.8|STANDARD_ERROR_OF_MEAN|9.42||0.4089|TWO_SIDED|90.0|-7.82|23.45||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||23.45|-7.82|0.4089
71058101|NCT04856917|141621536|SUPERIORITY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|2.53||0.4229|TWO_SIDED|90.0|-2.16|6.24||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||6.24|-2.16|0.4229
71058102|NCT04856917|141621536|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|2.56||0.6027|TWO_SIDED|90.0|-2.91|5.59||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||5.59|-2.91|0.6027
71058103|NCT04856917|141621536|SUPERIORITY||LS Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|2.5||0.2655|TWO_SIDED|90.0|-1.35|6.95||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||6.95|-1.35|0.2655
71058104|NCT04856917|141621536|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|2.53||0.6229|TWO_SIDED|90.0|-2.95|5.44||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||5.44|-2.95|0.6229
71108329|NCT01147302|141722242|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|4.56||||0.5103|TWO_SIDED|95.0|-7.25|16.37||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of chronic vasculitis score||16.37|-7.25|0.5103
71058105|NCT04856917|141621536|SUPERIORITY||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|3.74||0.4091|TWO_SIDED|90.0|-3.1|9.3||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||9.30|-3.10|0.4091
71058106|NCT04856917|141621536|SUPERIORITY||LS Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|3.83||0.1274|TWO_SIDED|90.0|-0.47|12.25||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||12.25|-0.47|0.1274
71058107|NCT04856917|141621536|SUPERIORITY||LS Mean Difference|4.8|STANDARD_ERROR_OF_MEAN|3.76||0.2075|TWO_SIDED|90.0|-1.47|11.01||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||11.01|-1.47|0.2075
71058108|NCT04856917|141621536|SUPERIORITY||LS Mean Difference|4.4|STANDARD_ERROR_OF_MEAN|3.77||0.2484|TWO_SIDED|90.0|-1.88|10.64||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||10.64|-1.88|0.2484
71058109|NCT04856917|141621536|SUPERIORITY||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|3.61||0.3399|TWO_SIDED|90.0|-2.53|9.45||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||9.45|-2.53|0.3399
71058110|NCT04856917|141621536|SUPERIORITY||LS Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|3.62||0.0545|TWO_SIDED|90.0|1.03|13.05||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||13.05|1.03|0.0545
71058111|NCT04856917|141621537|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|11.69||0.9679|TWO_SIDED|90.0|-19.86|18.91||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||18.91|-19.86|0.9679
71058112|NCT04856917|141621537|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|11.83||0.9152|TWO_SIDED|90.0|-20.87|18.35||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||18.35|-20.87|0.9152
71108330|NCT01147302|141722243|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|0.08||||0.7591|TWO_SIDED|95.0|-0.35|0.51||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 20||0.51|-0.35|0.7591
71108331|NCT01147302|141722243|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|-0.01||||0.9533|TWO_SIDED|95.0|-0.44|0.41||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 90||0.41|-0.44|0.9533
71058113|NCT04856917|141621537|SUPERIORITY||LS Mean Difference|7.3|STANDARD_ERROR_OF_MEAN|9.64||0.449|TWO_SIDED|90.0|-8.67|23.32||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||23.32|-8.67|0.4490
71058114|NCT04856917|141621537|SUPERIORITY||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|9.74||0.7246|TWO_SIDED|90.0|-12.72|19.6||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||19.60|-12.72|0.7246
71058115|NCT04856917|141621537|SUPERIORITY||LS Mean Difference|13.8|STANDARD_ERROR_OF_MEAN|18.88||0.4655|TWO_SIDED|90.0|-17.49|45.14||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||45.14|-17.49|0.4655
71058116|NCT04856917|141621537|SUPERIORITY||LS Mean Difference|30.5|STANDARD_ERROR_OF_MEAN|19.33||0.1178|TWO_SIDED|90.0|-1.59|62.54||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||62.54|-1.59|0.1178
71058117|NCT04856917|141621537|SUPERIORITY||LS Mean Difference|23.1|STANDARD_ERROR_OF_MEAN|17.71||0.1938|TWO_SIDED|90.0|-6.22|52.52||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||52.52|-6.22|0.1938
71108332|NCT01147302|141722244|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|1.45||||0.9046|TWO_SIDED|95.0|-19.34|22.24||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 20||22.24|-19.34|0.9046
70934863|NCT01638000|141370280|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.03||||0.44|TWO_SIDED|95.0|0.96|1.1||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Final Visit Rate Ratio vs. Mirabegron||1.10|0.96|0.44
70934864|NCT01638000|141370281|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.047||0.058|TWO_SIDED|95.0|0.0|0.18||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.18|-0.00|0.058
70934865|NCT01638000|141370281|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.044||0.5|TWO_SIDED|95.0|-0.06|0.12||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.12|-0.06|0.50
70934866|NCT01638000|141370281|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.046||0.81|TWO_SIDED|95.0|-0.08|0.1||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.10|-0.08|0.81
70934867|NCT01638000|141370282|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||0.67|TWO_SIDED|95.0|0.85|1.28||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 4 Odds ratio vs. Mirabegron||1.28|0.85|0.67
71058118|NCT04856917|141621537|SUPERIORITY||LS Mean Difference|29.7|STANDARD_ERROR_OF_MEAN|17.85||0.0991|TWO_SIDED|90.0|0.08|59.29||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||59.29|0.08|0.0991
71058119|NCT04856917|141621537|SUPERIORITY||LS Mean Difference|15.0|STANDARD_ERROR_OF_MEAN|15.44||0.3337|TWO_SIDED|90.0|-10.62|40.59||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||40.59|-10.62|0.3337
71108333|NCT01147302|141722244|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|4.68||||0.5895|TWO_SIDED|95.0|-10.19|19.55||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 90||19.55|-10.19|0.5895
70934868|NCT01638000|141370282|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.026|TWO_SIDED|95.0|1.03|1.53||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 8 Odds ratio vs. Mirabegron||1.53|1.03|0.026
70934869|NCT01638000|141370282|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.18||||0.11|TWO_SIDED|95.0|0.97|1.44||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds ratio vs. Mirabegron||1.44|0.97|0.11
70934870|NCT01638000|141370282|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.18||||0.093|TWO_SIDED|95.0|0.97|1.43||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final Visit Odds ratio vs. Mirabegron||1.43|0.97|0.093
70934871|NCT01638000|141370283|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.06||||0.74|TWO_SIDED|95.0|0.76|1.48||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 4 Odds Ratio vs. Mirabegron||1.48|0.76|0.74
70934872|NCT01638000|141370283|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.07||||0.74|TWO_SIDED|95.0|0.71|1.63||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 8 Odds Ratio vs. Mirabegron||1.63|0.71|0.74
70934873|NCT01638000|141370283|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.29|TWO_SIDED|95.0|0.81|2.0||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron||2.00|0.81|0.29
71108334|NCT01147302|141722245|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|1.56||||0.4558|TWO_SIDED|90.0|-2.0|5.11||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 1 through Day 20||5.11|-2.00|0.4558
71108335|NCT01147302|141722245|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|0.24||||0.947|TWO_SIDED|90.0|-6.05|6.52||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 1 through Day 90||6.52|-6.05|0.9470
71108336|NCT01342094|141722254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|||<|0.001|TWO_SIDED|95.0|-2.2|-0.9|||ANCOVA|||||-0.9|-2.2|< 0.001
71108337|NCT02121509|141722255|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|102.79|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|90.0|98.938|106.789|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)|||106.789|98.938|<0.0001
71108338|NCT02121509|141722255|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|101.45|STANDARD_ERROR_OF_MEAN|1.026|<|0.0001|TWO_SIDED|90.0|96.99|106.121|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fed/ L+M 1500 fed)|||106.121|96.990|<0.0001
71108339|NCT02121509|141722256|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|106.22|STANDARD_ERROR_OF_MEAN|1.046||0.0004|TWO_SIDED|90.0|98.449|114.614|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)|||114.614|98.449|0.0004
71108340|NCT02121509|141722256|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|106.71|STANDARD_ERROR_OF_MEAN|1.051||0.004|TWO_SIDED|90.0|97.614|116.658|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fed/ L+M 1500 fed)|||116.658|97.614|0.0040
71108341|NCT02121509|141722257|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|102.03|STANDARD_ERROR_OF_MEAN|1.05||0.0001|TWO_SIDED|90.0|94.03|110.72|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)|||110.72|94.03|0.0001
71108342|NCT02121509|141722257|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|96.36|STANDARD_ERROR_OF_MEAN|1.04||0.0002|TWO_SIDED|90.0|89.96|103.22|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fed/ L+M 1500 fed)|||103.22|89.96|0.0002
70934874|NCT01638000|141370283|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.29|TWO_SIDED|95.0|0.82|1.9||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron||1.90|0.82|0.29
71108343|NCT02121509|141722258|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|105.1|STANDARD_ERROR_OF_MEAN|1.057||0.0013|TWO_SIDED|90.0|95.829|115.269|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)|||115.269|95.829|0.0013
71108344|NCT02121509|141722258|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|113.91|STANDARD_ERROR_OF_MEAN|1.027||0.0018|TWO_SIDED|90.0|108.749|119.318|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fed/ L+M 1500 fed)|||119.318|108.749|0.0018
71108345|NCT02121509|141722259|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|101.45|STANDARD_ERROR_OF_MEAN|1.035|<|0.0001|TWO_SIDED|90.0|95.748|107.487|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)|||107.487|95.748|<0.0001
71108346|NCT02121509|141722259|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|106.33|STANDARD_ERROR_OF_MEAN|1.034||0.0002|TWO_SIDED|90.0|100.268|112.763|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fed/ L+M 1500 fed)|||112.763|100.268|0.0002
71108347|NCT02121509|141722260|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|102.07|STANDARD_ERROR_OF_MEAN|1.05|<|0.0001|TWO_SIDED|90.0|94.2|110.59|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)|||110.59|94.20|<0.0001
71025135|NCT01335477|141557439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.1005||0.26||95.0|-0.084|0.31|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline DLCO (HGB Corrected) \[mmol/min/kPa\], baseline DLCO (HGB Corrected) \[mmol/min/kPa\]-by-visit and random effect for patient.||0.310|-0.084|0.2600
70934875|NCT01638000|141370284|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.22||||0.2|TWO_SIDED|95.0|0.9|1.67||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 4 Odds Ratio vs. Mirabegron||1.67|0.90|0.20
71025136|NCT02040428|141557444|SUPERIORITY_OR_OTHER|||||||0.0001|ONE_SIDED||||||Adaptive group sequential design|Whitehead method for triangular test||Superiority||||0.0001
71025137|NCT02040428|141557445|SUPERIORITY_OR_OTHER|||||||0.0046|TWO_SIDED||||||Chi-squared|||||||0.0046
71025138|NCT00992264|141557458|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.51|1.51|||||OR for smoking abstinence at 12 months in intent to treat sample. Participants receiving content written in a Prescriptive tone were compared against persons receiving content in a Motivational tone (ref group).|Comparison of persons assigned to Prescriptive message tone (n = 932) against persons assigned to Motivational message tone (n = 933).||1.51|0.51|
71025139|NCT00992264|141557458|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.66|1.91|||||OR for smoking abstinence at 12 months when persons who randomly received a Testimonial were compared against persons receiving No Testimonial (ref group).|Comparison of persons assigned to Testimonials (n = 933) against persons assigned to receive no testimonials (n = 932).||1.91|0.66|
71025140|NCT00992264|141557458|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.7|2.02|||||OR for smoking abstinence at 12 months when persons assigned to Dictated navigation were compared to those not assigned to Dictated navigation (ref group).|Comparison of persons assigned to the Dictated Navigation arm (n = 934) against persons assigned to assigned free navigation of the website (n = 931).||2.02|0.70|
71025141|NCT00992264|141557458|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75|||||TWO_SIDED|95.0|0.43|1.3|||||OR for smoking abstinence at 12 months when persons assigned to receive Proactive Email reminders were compared against persons who received No Emails (ref group).|Comparison of persons assigned to Proactive Email Outreach (n = 933) against persons assigned to receive No Proactive Email Outreach (n = 932).||1.30|0.43|
71025142|NCT00992264|141557459|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.94|||||TWO_SIDED|95.0|0.62|1.43|||||OR for use of adjunct treatment at 12 months when persons assigned to Prescriptive Tone were compared to persons assigned to receive content in a Motivational Tone (ref group).|Comparison of persons assigned to Prescriptive message tone (n = 932) against persons assigned to Motivational message tone (n = 933).||1.43|0.62|
71025143|NCT00992264|141557459|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.46|1.07|||||OR for use of adjunct treatment at 12 months when persons assigned to receive a Testimonial were compared to persons assigned to receive No Testimonial (ref group).|Comparison of persons assigned to Testimonials (n = 933) against persons assigned to receive no testimonials (n = 932).||1.07|0.46|
71025144|NCT00992264|141557459|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.51|1.18|||||OR for use of adjunct treatment at 12 months when persons assigned to Dictated Navigation were compared to persons not assigned to Dictated Navigation (ref group).|Comparison of persons assigned to the Dictated Navigation arm (n = 934) against persons assigned to assigned free navigation of the website (n = 931).||1.18|0.51|
71058120|NCT04856917|141621537|SUPERIORITY||LS Mean Difference|31.2|STANDARD_ERROR_OF_MEAN|15.48||0.0465|TWO_SIDED|90.0|5.5|56.87||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||56.87|5.50|0.0465
71025145|NCT00992264|141557459|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.44|1.03|||||OR for use of adjunct treatment at 12 months when persons assigned to Proactive Email reminders were compared to persons not assigned to receive Proactive Email reminders (ref group).|Comparison of persons assigned to Proactive Email Outreach (n = 933) against persons assigned to receive No Proactive Email Outreach (n = 932).||1.03|0.44|
71025146|NCT00449072|141557488|SUPERIORITY_OR_OTHER||Difference (LS Mean)|-0.45||||0.0096|TWO_SIDED|95.0|-0.78|-0.11|||ANCOVA|The treatment arm, age group (at Visit 1) and sex were fixed effects, and baseline growth velocity was a covariate in the ANCOVA model||||-0.11|-0.78|0.0096
71108348|NCT02121509|141722260|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|96.79|STANDARD_ERROR_OF_MEAN|1.04||0.0001|TWO_SIDED|90.0|90.33|103.7|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fed/ L+M 1500 fed)|||103.70|90.33|0.0001
71108349|NCT04021290|141722296|NON_INFERIORITY|Non-inferiority was be concluded if the upper bound of the two-sided 95% confidence interval (CI) for the CMH adjusted difference in the proportion of patients with plasma HIV-1 RNA ≥ 50 c/mL between each treatment group (DTG/3TC - CAR) is less than 5%.|Adjusted Difference in Percent (ADP)|-0.8|||||TWO_SIDED|95.0|-2.4|0.8|||||ADP was based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factor:Baseline third agent (protease inhibitor \[PI\], non-nucleoside reverse transcriptase inhibitor \[NNRTI\], and integrase inhibitor \[INI\]).|||0.8|-2.4|
71108350|NCT04021290|141722297|NON_INFERIORITY|Non-inferiority will be concluded if the lower bound of a 2-sided 95% confidence interval for the difference in success rates between the two treatment arms (DTG/3TC-CAR) is greater than -12%.|Adjusted Difference in Percent|1.6|||||TWO_SIDED|95.0|-2.8|5.9|||||ADP was based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factor:Baseline third agent (PI, NNRTI, and INI).|||5.9|-2.8|
71108351|NCT04021290|141722318|OTHER||Adjusted Mean|1.4|||<|0.001|TWO_SIDED|95.0|0.7|2.2|||Mixed Model Repeated Measures||MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Age (continuous), Sex, Race, Baseline Value (continuous), Treatment by Visit interaction, Baseline Value by Visit interaction, with Visit as the repeated factor.|||2.2|0.7|<0.001
71108352|NCT04021290|141722319|OTHER||Adjusted Mean|1.4|||<|0.001|TWO_SIDED|95.0|0.7|2.2|||Mixed Model Repeated Measures||MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Age (continuous), Sex, Race, Baseline Value (continuous), Treatment by Visit interaction, Baseline Value by Visit interaction, with Visit as the repeated factor.|||2.2|0.7|<0.001
71108353|NCT04021290|141722320|OTHER||Adjusted Mean|-1.6||||0.021|TWO_SIDED|95.0|-2.9|-0.2|||Mixed Model Repeated Measures||MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Age (continuous), Sex, Race, Baseline Value (continuous), Treatment by Visit interaction, Baseline Value by Visit interaction, with Visit as the repeated factor.|||-0.2|-2.9|0.021
71108354|NCT04021290|141722321|OTHER||Adjusted Mean|-0.5||||0.398|TWO_SIDED|95.0|-1.8|0.7|||Mixed Model Repeated Measures||MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Age (continuous), Sex, Race, Baseline Value (continuous), Treatment by Visit interaction, Baseline Value by Visit interaction, with Visit as the repeated factor.|||0.7|-1.8|0.398
71108355|NCT00636181|141722323|SUPERIORITY|||||||0.3||||||PSG outcomes employed analysis of variance for approximately normally distributed outcomes (or outcomes that could be transformed to an approximately normal distribution), and the Kruskal-Wallis test for non-normal outcomes.|Kruskal-Wallis|Pairwise differences were determined using Tukey-Kramer test- ANOVA applied or by Mann-Whitney-Wilcoxon summed rank tests and Bonferroni adjustment.||||||0.3
70934876|NCT01638000|141370284|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.91||||0.57|TWO_SIDED|95.0|0.65|1.26||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 8 Odds Ratio vs. Mirabegron||1.26|0.65|0.57
71025147|NCT00449072|141557489|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.12||||0.7341|TWO_SIDED|95.0|-0.83|0.58|||ANCOVA||The treatment arm, sex and age group were fixed effects, and baseline value was a covariate in the ANCOVA model.|||0.58|-0.83|0.7341
71025148|NCT00449072|141557490|SUPERIORITY_OR_OTHER||LS Mean Differerence|-0.15||||0.1963|TWO_SIDED|95.0|-0.37|0.08|||ANCOVA||The treatment arm, sex and age group were fixed effects, and baseline value was a covariate in the ANCOVA model.|Change in nasal stuffiness||0.08|-0.37|0.1963
71025149|NCT00449072|141557490|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.7193|TWO_SIDED|95.0|-0.24|0.17|||ANCOVA||The treatment arm, sex and age group were fixed effects, and baseline value was a covariate in the ANCOVA model.|Change in Nasal Discharge||0.17|-0.24|0.7193
71025150|NCT00449072|141557490|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.402|TWO_SIDED|95.0|-0.12|0.29|||ANCOVA||The treatment arm, sex and age group were fixed effects, and baseline value was a covariate in the ANCOVA model.|Change in Sneezing||0.29|-0.12|0.4020
71025151|NCT00449072|141557490|SUPERIORITY_OR_OTHER||LS mean Difference|-0.02||||0.8854|TWO_SIDED|95.0|-0.23|0.2|||ANCOVA||The treatment arm, sex and age group were fixed effects, and baseline value was a covariate in the ANCOVA model.|Change in Nasal Itching||0.20|-0.23|0.8854
71025152|NCT00449072|141557491|SUPERIORITY_OR_OTHER|||||||0.0951||95.0|||||Mixed model for repeated measures|The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.||Statistical Analysis for Day 120||||0.0951
71025153|NCT00449072|141557491|SUPERIORITY_OR_OTHER|||||||0.1247||95.0|||||Mixed model for repeated measures|The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.||Statistical analysis for Day 240||||0.1247
71025154|NCT00449072|141557491|SUPERIORITY_OR_OTHER|||||||0.0207||95.0|||||Mixed model for repeated measures|The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.||Statistical analysis for Day 360||||0.0207
71025155|NCT00449072|141557492|SUPERIORITY_OR_OTHER|||||||0.2445||95.0|||||Mixed model for repeated measures|The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.||Statistical Analysis for Day 120||||0.2445
71025156|NCT00449072|141557492|SUPERIORITY_OR_OTHER|||||||0.4488||95.0|||||Mixed model for repeated measures|The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.||Statistical Analysis for Day 240||||0.4488
71025157|NCT00449072|141557492|SUPERIORITY_OR_OTHER|||||||0.0142||95.0||||The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.|Mixed model for repeated measures|||Statistical Analysis for Day 360||||0.0142
71025158|NCT02022007|141557503|SUPERIORITY_OR_OTHER|||||||0.007|||||||McNemar|||Study change from dysglycemia to normal glucose state||||.007
71025159|NCT02022007|141557504|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANOVA|||This was a Subjects (SS)/Groups repeated measures design||||.02
71025160|NCT02022007|141557505|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|n||Pretreatment fasting glucose levels were compared with post-treatment levels||||<0.0001
71025161|NCT02022007|141557506|SUPERIORITY_OR_OTHER|||||||0.038|||||||ANOVA|||||||.038
71025162|NCT02022007|141557507|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANOVA|||||||0.003
71025163|NCT02022007|141557508|SUPERIORITY_OR_OTHER|||||||0.025|||||||ANOVA|||||||.025
71025164|NCT02022007|141557509|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA|||||||0.006
71025165|NCT02022007|141557510|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA|||||||.006
71025166|NCT02022007|141557511|SUPERIORITY_OR_OTHER|||||||0.026|||||||ANOVA|||||||.026
71025167|NCT02022007|141557512|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA|||||||.006
71025168|NCT02022007|141557513|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA|||||||.006
71025169|NCT02022007|141557514|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||||||>0.05
71025170|NCT00818623|141557626|SUPERIORITY_OR_OTHER_LEGACY|||||||5.86e-05||95.0|||||Log Rank|||||||0.0000586
71025171|NCT00818623|141557627|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014||95.0|||||Kruskal-Wallis|||||||0.0014
71025172|NCT00818623|141557627|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|87.5||||||95.0|66.1|95.8||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||95.8|66.1|
71025173|NCT00818623|141557627|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|66.7||||||95.0|33.7|86.0||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||86|33.7|
71025174|NCT00818623|141557627|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|54.5||||||95.0|22.9|78.0||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||78|22.9|
71025175|NCT00818623|141557627|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|100.0||||||95.0|85.8|100.0||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||100|85.8|
71025176|NCT00818623|141557627|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|75.0||||||95.0|52.6|87.9||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||87.9|52.6|
71025177|NCT00818623|141557627|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|95.7||||||95.0|72.9|99.4||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||99.4|72.9|
71025178|NCT00818623|141557627|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|62.5||||||95.0|40.3|78.4||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||78.4|40.3|
71025179|NCT00818623|141557627|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|88.9||||||95.0|69.4|96.3||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||96.3|69.4|
71025180|NCT00818623|141557628|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0031||95.0|||||Kruskal-Wallis|||||||0.0031
71025181|NCT00818623|141557628|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|45.8||||||95.0|25.6|64.0||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||64|25.6|
70934877|NCT01638000|141370284|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.98||||0.92|TWO_SIDED|95.0|0.69|1.39||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron||1.39|0.69|0.92
71108356|NCT05076045|141722370|SUPERIORITY|||||||0.03||||||This p-value has been adjusted using the Bonferroni correction. The threshold for statistical significance was p = 0.05 (two-sided).|Mixed Models Analysis|Results of the pairwise comparisons for the SNR by Session interaction in the linear mixed model analysis.||Null hypothesis is that there was no difference in percentage of correct answers between PSAPs and Control. Data were analyzed using a linear mixed-effects (LME) model. The model included session (PSAPs, Control) and signal-to-noise ratio (SNR) as within-subject factors. Participants were included as a random factor.||||0.03
71108357|NCT05076045|141722371|SUPERIORITY|||||||0.28||||||The threshold for statistical significance was p = 0.05 (two-sided).|Mixed Models Analysis|||Null hypothesis is that there was no difference in reaction time between PSAPs and Control. Data were analyzed using a linear mixed-effects (LME) model. The model included session (PSAPs, Control) and signal-to-noise ratio as within-subject factors. Participants were included as a random factor.||||0.28
71108358|NCT05076045|141722372|SUPERIORITY|||||||0.005||||||The threshold for statistical significance was p = 0.05 (two-sided).|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in Quick Speech In Noise score between PSAPs and Control. The performance of the QuickSIN for the two sessions (PSAPs, Control) was compared using the Wilcoxon signed rank test on paired samples.||||0.005
71108359|NCT05076045|141722373|SUPERIORITY|||||||1||||||This p-value has been adjusted using the Bonferroni correction. The threshold for statistical significance was p = 0.05 (two-sided).|Mixed Models Analysis|Result of the pairwise comparisons for the SNR by Session interaction in the linear mixed model analysis.||Null hypothesis is that there was no difference in alpha power between PSAPs and Control. Data were analyzed using a linear mixed-effects (LME) model. The model included session (PSAPs, Control) and signal-to-noise ratio (SNR) as within-subject factors. Participants were included as a random factor.||||1.00
71108360|NCT05076045|141722374|SUPERIORITY|This p-value has been adjusted using the Bonferroni correction. The threshold for statistical significance was p = 0.05 (two-sided).||||||1|||||||Mixed Models Analysis|Result of the pairwise comparisons for the SNR by Session interaction in the linear mixed model analysis.||Null hypothesis is that there was no difference in alpha power between PSAPs and Control. Data were analyzed using a linear mixed-effects (LME) model. The model included session (PSAPs, Control) and signal-to-noise ratio (SNR) as within-subject factors. Participants were included as a random factor.||||1.00
71108361|NCT05076045|141722375|SUPERIORITY|||||||0.36||||||This p-value has been adjusted using the Bonferroni correction. The threshold for statistical significance was p = 0.05 (two-sided).|Mixed Models Analysis|Result of the pairwise comparisons for the SNR by Session interaction in the linear mixed model analysis.||Null hypothesis is that there was no difference in alpha power between PSAPs and Control. Data were analyzed using a linear mixed-effects (LME) model. The model included session (PSAPs, Control) and signal-to-noise ratio (SNR) as within-subject factors. Participants were included as a random factor.||||0.36
71108362|NCT05076045|141722376|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p = 0.05 (two-sided).|Cumulative link mixed model|||Null hypothesis is that there was no difference in listening effort between PSAPs and Control. The listening effort score was analyzed using a cumulative link mixed model. A logit link function with flexible thresholds was used. The model included Session (PSAPs, Control) and Block (1, 2, 3) as within-subject factors. Participants were included as a random factor.||||<0.001
70934878|NCT01638000|141370284|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.02||||0.9|TWO_SIDED|95.0|0.73|1.42||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron||1.42|0.73|0.90
71025182|NCT00818623|141557628|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|38.1||||||95.0|12.1|64.3||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||64.3|12.1|
71108363|NCT03391882|141722377|SUPERIORITY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|1.722||0.8944|TWO_SIDED|95.0|-3.16|3.62|||Mixed Models Analysis|||||3.62|-3.16|0.8944
71108364|NCT03391882|141722378|SUPERIORITY||Odds Ratio (OR)|1.129||||0.7777|TWO_SIDED|95.0|0.484|2.637|||generalized linear random effects model|||||2.637|0.484|0.7777
71108365|NCT03391882|141722379|SUPERIORITY|||||||0.0002|TWO_SIDED|||||The p-value is from a 1-sample, 2-sided test of the null hypothesis that the true proportion preferring APL is 50% to evaluate if a significantly higher proportion of the subjects prefer APL-130277 or not.|binomial distribution with normal approx|||||||0.0002
71108366|NCT03391882|141722380|SUPERIORITY||Odds Ratio (OR)|1.835||||0.1769|TWO_SIDED|95.0|0.759|4.438|||generalized linear random effects model|||||4.438|0.759|0.1769
70934879|NCT01638000|141370305|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.69|STANDARD_ERROR_OF_MEAN|0.817||0.039|TWO_SIDED|95.0|-3.29|-0.08||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 4 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.08|-3.29|0.039
71025183|NCT00818623|141557628|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|32.7||||||95.0|8.3|60.6||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||60.6|8.3|
71108367|NCT03391882|141722381|SUPERIORITY||Odds Ratio (OR)|1.47||||0.3922|TWO_SIDED|95.0|0.61|3.53|||generalized linear random effects model|||||3.53|0.61|0.3922
71108368|NCT02878382|141722396|SUPERIORITY||||||<|0.001||||||significance level of 5%|Chi-squared|also, Fisher's exact test and Mann-Whtiney were used for comparing the other variables in the study||||||<0.001
71108369|NCT02878382|141722398|SUPERIORITY||||||=|0.001||||||significance level of 5%|Fisher Exact|||||||=0.001
71108370|NCT02878382|141722399|SUPERIORITY||||||=|0.048|||||||Wilcoxon (Mann-Whitney)|||Student's t-test or the Mann-Whitney test was used according to the assumption of normality of data for PpIX fluorescence intensity||||=0.048
71108371|NCT01634152|141722406|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.035|STANDARD_ERROR_OF_MEAN|0.032||0.2724|TWO_SIDED|95.0|-0.028|0.099|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis was performed in a stepwise manner, firstly for this endpoint, then Trough FEV1. Each step was only considered confirmatory if all previous steps were successful.||0.099|-0.028|0.2724
71108372|NCT01634152|141722406|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.139|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.075|0.203|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis was performed in a stepwise manner, firstly for this endpoint, then Trough FEV1. Each step was only considered confirmatory if all previous steps were successful.||0.203|0.075|<0.0001
71108373|NCT01634152|141722407|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.018|STANDARD_ERROR_OF_MEAN|0.034||0.5898|TWO_SIDED|95.0|-0.048|0.085|||Mixed Models Analysis|Repeated measures restricted maximum likelihood|Difference calculated as Tio R2.5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis for this endpoint was performed in a stepwise manner after the analysis of the primary endpoint was performed. Each step was only considered confirmatory if all previous steps were successful.||0.085|-0.048|0.5898
71108374|NCT01634152|141722407|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.087|STANDARD_ERROR_OF_MEAN|0.034||0.0117|TWO_SIDED|95.0|0.019|0.154|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis for this endpoint was performed in a stepwise manner after the analysis of the primary endpoint was performed. Each step was only considered confirmatory if all previous steps were successful.||0.154|0.019|0.0117
71108375|NCT01634152|141722408|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.036||0.2277|TWO_SIDED|95.0|-0.113|0.027|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.027|-0.113|0.2277
70851856|NCT02034409|141191902|NON_INFERIORITY|For the 48-week OMERACT-OARSI response the minimally clinically significant difference is an absolute rate difference of 10% between sham and PLIUS groups. With a total sample size of 144 the probability of correctly selecting the group with the greatest OORR is at least 0.885 assuming (δ=10%) that the sham group is drawn from a population with a 50% response rate and the PLIUS group is drawn from a population with response rate of at least 60% or at most 40%.||||||||||||||||Sample size has been calculated with ranking and selection methodology, a procedure used for Phase II trials. The purpose of the procedure as applied to this study is to identify whether PLIUS has a high probability of being more effective than sham. This is accomplished by obtaining sample estimates of the outcome for the PLIUS and sham groups and determining whether the PLIUS group outcome is better by the pre-specified margin of difference.|Since the ranking and selection procedures are fundamentally different from traditional hypothesis testing, concepts of statistical significance and power have no direct analogue.|||
71025184|NCT00818623|141557628|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|83.3||||||95.0|61.5|93.4||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||93.4|61.5|
71025185|NCT00818623|141557628|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|49.4||||||95.0|28.3|67.4||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||67.4|28.3|
71108376|NCT01634152|141722408|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.036||0.3998|TWO_SIDED|95.0|-0.04|0.101|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.101|-0.040|0.3998
71108377|NCT01634152|141722409|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.048|STANDARD_ERROR_OF_MEAN|0.037||0.203|TWO_SIDED|95.0|-0.121|0.026|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.026|-0.121|0.2030
71108378|NCT01634152|141722409|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.009|STANDARD_ERROR_OF_MEAN|0.038||0.8194|TWO_SIDED|95.0|-0.066|0.083|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.083|-0.066|0.8194
71108379|NCT01634152|141722410|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.031|STANDARD_ERROR_OF_MEAN|0.029||0.2907|TWO_SIDED|95.0|-0.026|0.088|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.088|-0.026|0.2907
71108380|NCT01634152|141722410|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.126|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.068|0.184|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.184|0.068|<0.0001
71108381|NCT01634152|141722411|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.041|STANDARD_ERROR_OF_MEAN|0.032||0.2008|TWO_SIDED|95.0|-0.103|0.022|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.022|-0.103|0.2008
71108382|NCT01634152|141722411|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.037|STANDARD_ERROR_OF_MEAN|0.032||0.2545|TWO_SIDED|95.0|-0.026|0.1|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.100|-0.026|0.2545
71108383|NCT01634152|141722414|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.078||0.798|TWO_SIDED|95.0|-0.133|0.173|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.173|-0.133|0.7980
71108384|NCT01634152|141722414|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.079|STANDARD_ERROR_OF_MEAN|0.079||0.3166|TWO_SIDED|95.0|-0.233|0.076|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.076|-0.233|0.3166
71108385|NCT01634152|141722416|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.017|STANDARD_ERROR_OF_MEAN|0.124||0.8916|TWO_SIDED|95.0|-0.227|0.261|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.261|-0.227|0.8916
71108386|NCT01634152|141722416|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.089|STANDARD_ERROR_OF_MEAN|0.126||0.4789|TWO_SIDED|95.0|-0.336|0.158|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.158|-0.336|0.4789
71108387|NCT01634152|141722417|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.015|STANDARD_ERROR_OF_MEAN|0.074||0.8361|TWO_SIDED|95.0|-0.16|0.129|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.129|-0.160|0.8361
71025186|NCT00818623|141557628|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|82.0||||||95.0|58.8|92.8||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||92.8|58.8|
71108388|NCT01634152|141722417|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.087|STANDARD_ERROR_OF_MEAN|0.075||0.2461|TWO_SIDED|95.0|-0.233|0.06|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.060|-0.233|0.2461
71108389|NCT01634152|141722418|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.035|STANDARD_ERROR_OF_MEAN|0.067||0.6029|TWO_SIDED|95.0|-0.096|0.165|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.165|-0.096|0.6029
71108390|NCT01634152|141722418|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.026|STANDARD_ERROR_OF_MEAN|0.067||0.7034|TWO_SIDED|95.0|-0.158|0.107|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.107|-0.158|0.7034
71108391|NCT01634152|141722419|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.776|STANDARD_ERROR_OF_MEAN|4.686||0.3083|TWO_SIDED|95.0|-4.419|13.97|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||13.970|-4.419|0.3083
71025187|NCT00818623|141557628|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|50.0||||||95.0|29.1|67.8||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||67.8|29.1|
71108392|NCT01634152|141722419|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.743|STANDARD_ERROR_OF_MEAN|4.747||0.3179|TWO_SIDED|95.0|-4.571|14.057|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||14.057|-4.571|0.3179
71108393|NCT01634152|141722420|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.567|STANDARD_ERROR_OF_MEAN|4.807||0.9061|TWO_SIDED|95.0|-8.866|10.001|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||10.001|-8.866|0.9061
71108394|NCT01634152|141722420|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.107|STANDARD_ERROR_OF_MEAN|4.867||0.399|TWO_SIDED|95.0|-13.658|5.444|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||5.444|-13.658|0.3990
71108395|NCT01634152|141722421|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.95|STANDARD_ERROR_OF_MEAN|1.025||0.3542|TWO_SIDED|95.0|-2.959|1.06|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||1.060|-2.959|0.3542
71108396|NCT01634152|141722421|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.502|STANDARD_ERROR_OF_MEAN|1.042||0.6298|TWO_SIDED|95.0|-2.545|1.541|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||1.541|-2.545|0.6298
71108397|NCT01634152|141722422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.032|STANDARD_ERROR_OF_MEAN|0.038||0.4066|TWO_SIDED|95.0|-0.107|0.043|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.043|-0.107|0.4066
71108398|NCT01634152|141722422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.049|STANDARD_ERROR_OF_MEAN|0.039||0.2032|TWO_SIDED|95.0|-0.125|0.027|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.027|-0.125|0.2032
71108399|NCT01634152|141722423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.051|STANDARD_ERROR_OF_MEAN|0.041||0.2064|TWO_SIDED|95.0|-0.131|0.028|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.028|-0.131|0.2064
71108400|NCT01634152|141722423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.061|STANDARD_ERROR_OF_MEAN|0.041||0.141|TWO_SIDED|95.0|-0.142|0.02|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.020|-0.142|0.1410
71108401|NCT01634152|141722424|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.001|STANDARD_ERROR_OF_MEAN|0.042||0.9869|TWO_SIDED|95.0|-0.083|0.082|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.082|-0.083|0.9869
71108402|NCT01634152|141722424|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.007|STANDARD_ERROR_OF_MEAN|0.043||0.873|TWO_SIDED|95.0|-0.077|0.09|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.090|-0.077|0.8730
71108403|NCT01634152|141722425|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.006|STANDARD_ERROR_OF_MEAN|0.049||0.9043|TWO_SIDED|95.0|-0.103|0.091|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.091|-0.103|0.9043
71108404|NCT01634152|141722425|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.015|STANDARD_ERROR_OF_MEAN|0.05||0.7708|TWO_SIDED|95.0|-0.112|0.083|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.083|-0.112|0.7708
71108405|NCT01634152|141722426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.036|STANDARD_ERROR_OF_MEAN|0.052||0.4864|TWO_SIDED|95.0|-0.139|0.066|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.066|-0.139|0.4864
71108406|NCT01634152|141722426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.013|STANDARD_ERROR_OF_MEAN|0.053||0.7991|TWO_SIDED|95.0|-0.117|0.09|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.090|-0.117|0.7991
71108407|NCT01634152|141722427|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.007|STANDARD_ERROR_OF_MEAN|0.05||0.8884|TWO_SIDED|95.0|-0.092|0.106|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.106|-0.092|0.8884
70934880|NCT01638000|141370305|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.849||0.034|TWO_SIDED|95.0|-3.46|-0.13||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 8 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.13|-3.46|0.034
71108408|NCT01634152|141722427|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.012|STANDARD_ERROR_OF_MEAN|0.051||0.8115|TWO_SIDED|95.0|-0.112|0.088|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.088|-0.112|0.8115
71108409|NCT01634152|141722428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.016|STANDARD_ERROR_OF_MEAN|0.051||0.7498|TWO_SIDED|95.0|-0.084|0.117|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.117|-0.084|0.7498
71108410|NCT01634152|141722428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.083|STANDARD_ERROR_OF_MEAN|0.052||0.1108|TWO_SIDED|95.0|-0.185|0.019|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.019|-0.185|0.1108
71108411|NCT01634152|141722429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.015|STANDARD_ERROR_OF_MEAN|0.059||0.8055|TWO_SIDED|95.0|-0.131|0.102|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.102|-0.131|0.8055
71108412|NCT01634152|141722429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.071|STANDARD_ERROR_OF_MEAN|0.06||0.236|TWO_SIDED|95.0|-0.189|0.047|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.047|-0.189|0.2360
71108413|NCT01634152|141722430|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.017|STANDARD_ERROR_OF_MEAN|0.041||0.6748|TWO_SIDED|95.0|-0.097|0.063|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.063|-0.097|0.6748
71108414|NCT01634152|141722430|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.025|STANDARD_ERROR_OF_MEAN|0.041||0.5497|TWO_SIDED|95.0|-0.056|0.105|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.105|-0.056|0.5497
71108415|NCT01482715|141722432|OTHER||RP2D|600.0|||||TWO_SIDED||||||||||A MTD was not established based on observation of DLTs in Cycle 1 of treatment. The 600 mg BID dose was considered to be the maximum dose with an acceptable toxicity profile that could be continuously administered to patients and was selected as the recommended Phase 2 dose (RP2D).|||
71108416|NCT01152437|141722450|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.122||||0.0735|TWO_SIDED|90.0|0.018|0.844||The statistical analysis is descriptive and exploratory in nature and performed only to provide a statistical framework from which to view the results and plan further studies.|Regression, Logistic|Wald Chi-square test and Confidence Interval from logistic regression stratified by number of lines of palliative chemotherapy.||Null hypothesis is that the objective response rate (ORR) in KRAS wild-type patients treated with afatinib is less than or equal to the ORR in KRAS wild-type patients treated with cetuximab. Sample size is based on a 'pick the winner' approach assuming ORR for cetuximab of 12%, undesirable ORR for afatinib of 11% and desirable ORR for afatinib of 16%. As per 'pick the winner' approach, afatinib would be considered 'the winner' if the ORR for afatinib was greater than the ORR for cetuximab.||0.844|0.018|0.0735
71108417|NCT01152437|141722451|SUPERIORITY_OR_OTHER||Percentage of participants|12.0||||0.6394|TWO_SIDED|90.0|4.9|23.9||The statistical analysis is descriptive and exploratory in nature and performed only to provide a statistical framework from which to view the results and plan further studies.|Exact binomial test|||Null hypothesis is that the disease control rate is 10% in patients with KRAS mutation. Sample size calculation based on a 2-sided exact binomial test at 10% significance level to distinguish between the historical disease control rate of 10% and a desirable disease control rate for afatinib of 25%.||23.9|4.9|0.6394
71108418|NCT00279214|141722460|SUPERIORITY_OR_OTHER|||||||0.238||95.0|||||Repeated Measures - propensity adjusted|||24-Hour p-value||||0.238
71108419|NCT00279214|141722460|SUPERIORITY_OR_OTHER|||||||0.281||95.0||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.281
71108420|NCT00279214|141722461|SUPERIORITY_OR_OTHER|||||||0.478||95.0||||P-value for 96 Hour Change from Baseline.|Mixed Models Analysis|Model: Outcome=Therapy + Sedative Indicator + Time + Therapy\*Time + Propensity Score||||||0.478
71108421|NCT00279214|141722462|SUPERIORITY_OR_OTHER|||||||0.442||95.0||||24-Hour p-value|Repeated Measures - propensity adjusted|||||||0.442
70941698|NCT04748445|141383934|OTHER||Slope|-1.008|STANDARD_ERROR_OF_MEAN|1.778||0.5716|TWO_SIDED|90.0|-3.955|1.938|||Mixed Models Analysis|||READ\_MFCC std 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||1.938|-3.955|0.5716
70941699|NCT04748445|141383934|OTHER||Slope|-0.0223|STANDARD_ERROR_OF_MEAN|1.193||0.064|TWO_SIDED|90.0|-0.04208|-0.002526|||Mixed Models Analysis|||READ\_MFCC std 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.002526|-0.04208|0.0640
71108422|NCT00279214|141722462|SUPERIORITY_OR_OTHER|||||||0.871||95.0||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.871
71108423|NCT00279214|141722463|SUPERIORITY_OR_OTHER|||||||0.704||95.0||||24-Hour p-value|Repeated Measures - propensity adjusted|||||||0.704
71108424|NCT00279214|141722463|SUPERIORITY_OR_OTHER|||||||0.702||95.0||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.702
71108425|NCT00279214|141722464|SUPERIORITY_OR_OTHER|||||||0.061||95.0||||6-Hour p-value|Repeated Measures - propensity adjusted|||||||0.061
71108426|NCT00279214|141722464|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||6-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.027
71108427|NCT00279214|141722465|SUPERIORITY_OR_OTHER|||||||0.242||95.0||||Baseline p-value|Repeated Measures - propensity adjusted|||||||0.242
71108428|NCT00279214|141722465|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||12-Hour p-value|Repeated Measures - propensity adjusted|||||||0.083
71108429|NCT00279214|141722465|SUPERIORITY_OR_OTHER|||||||0.81||95.0||||24-Hour p-value|Repeated Measures - propensity adjusted|||||||0.810
71108430|NCT00279214|141722465|SUPERIORITY_OR_OTHER|||||||0.623||95.0||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.623
71108431|NCT00279214|141722466|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||Baseline p-value|Repeated Measures - propensity adjusted|||||||0.686
71108432|NCT00279214|141722466|SUPERIORITY_OR_OTHER|||||||0.575||95.0||||24-Hour p-value|Repeated Measures - propensity adjusted|||||||0.575
71108433|NCT00279214|141722467|SUPERIORITY_OR_OTHER|||||||0.165||95.0|||||Repeated Measures - propensity adjusted|||||||0.165
71108434|NCT00279214|141722469|SUPERIORITY_OR_OTHER|||||||0.552||95.0||||Baseline p-value|Repeated Measures - propensity adjusted|||||||0.552
71108435|NCT00279214|141722469|SUPERIORITY_OR_OTHER|||||||0.129||95.0||||12-Hour p-value|Repeated Measures - propensity adjusted|||||||0.129
71108436|NCT00279214|141722469|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||24-Hour p-value|Repeated Measures - propensity adjusted|||||||0.030
71108437|NCT00279214|141722469|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.002
71108438|NCT00279214|141722471|SUPERIORITY_OR_OTHER|||||||0.128||95.0||||24-Hour p-value|Repeated Measures - propensity adjusted|||||||0.128
71025188|NCT00818623|141557628|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|70.4||||||95.0|49.4|83.9||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||83.9|49.4|
71108439|NCT00279214|141722471|SUPERIORITY_OR_OTHER|||||||0.234||95.0||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.234
71108440|NCT01214837|141722473|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups C, W and Y between the 3-dose series and (minus) the 4-dose series, is greater than -10%.|Vaccine group difference|-7.0|||||TWO_SIDED|95.0|-14.0|-1.0|||Miettinen and Nurminen method|||Non-inferiority of Men ACWY 3-dose series (doses at 2, 4 and 12 months) to 4-dose series (doses at 2, 4, 6 and 12 months of age) against serogroup A at 13 months of age.||-1|-14|
71108441|NCT01214837|141722473|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups C, W and Y between the 3-dose series and (minus) the 4-dose series, is greater than -10%.|Vaccine group difference|-4.0|||||TWO_SIDED|95.0|-8.0|0.0|||Miettinen and Nurminen method|||Non-inferiority of Men ACWY 3-dose series (doses at 2, 4 and 12 months) to 4-dose series (doses at 2, 4, 6 and 12 months of age) against serogroup C at 13 months of age.||0|-8|
71108442|NCT01214837|141722473|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups C, W and Y between the 3-dose series and (minus) the 4-dose series, is greater than -10%.|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0|||Miettinen and Nurminen method|||Non-inferiority of Men ACWY 3-dose series (doses at 2, 4 and 12 months) to 4-dose series (doses at 2, 4, 6 and 12 months of age) against serogroup W at 13 months of age.||3|-3|
71108443|NCT01214837|141722473|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups C, W and Y between the 3-dose series and (minus) the 4-dose series, is greater than -10%.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0|||Miettinen and Nurminen method|||Non-inferiority of Men ACWY 3-dose series (doses at 2, 4 and 12 months) to 4-dose series (doses at 2, 4, 6 and 12 months of age) against serogroup Y at 13 months of age.||4|-2|
71108444|NCT01214837|141722480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-0.5|||||TWO_SIDED|95.0|-6.1|5.0|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 1.||5|-6.1|
71108445|NCT01214837|141722480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|5.8|||||TWO_SIDED|95.0|3.0|10.5|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 1.||10.5|3|
71117628|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
71108446|NCT01214837|141722480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-11.9|6.0|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 3.||6|-11.9|
71108447|NCT01214837|141722480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|5.3|||||TWO_SIDED|95.0|-3.3|13.7|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 3.||13.7|-3.3|
71108448|NCT01214837|141722480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-2.4|||||TWO_SIDED|95.0|-7.5|2.3|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 4.||2.3|-7.5|
70934881|NCT01638000|141370305|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.917||0.022|TWO_SIDED|95.0|-3.9|-0.3||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.30|-3.90|0.022
70934882|NCT01638000|141370305|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.87|STANDARD_ERROR_OF_MEAN|0.924||0.043|TWO_SIDED|95.0|-3.68|-0.06||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.06|-3.68|0.043
70934883|NCT01638000|141370306|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.14|STANDARD_ERROR_OF_MEAN|0.77||0.14|TWO_SIDED|95.0|-0.37|2.65||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 4 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||2.65|-0.37|0.14
70934884|NCT01638000|141370306|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.55|STANDARD_ERROR_OF_MEAN|0.805||0.055|TWO_SIDED|95.0|-0.03|3.13||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariates.||Week 8 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||3.13|-0.03|0.055
71025189|NCT00818623|141557629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0866||95.0|||||Log Rank|||||||0.0866
71025190|NCT00818623|141557630|SUPERIORITY_OR_OTHER_LEGACY|||||||0.033||95.0|||||Log Rank|||||||0.033
71025191|NCT00818623|141557631|SUPERIORITY_OR_OTHER_LEGACY|||||||0.131||95.0|||||Log Rank|||||||0.131
71025192|NCT02649231|141557637|SUPERIORITY||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.28|1.75||||||Confirmed alcohol relapse by drug condition at 6 months using the Alcohol Timeline-Followback. Logistic regression modelling was used to compare the ketamine group with the placebo group (combined across therapy and alcohol education).||1.75|0.28|
71025193|NCT02649231|141557638|SUPERIORITY||Mean Difference (Final Values)|10.1|||||TWO_SIDED|95.0|1.1|19.0||||||Linear regression modelling was used to compare the ketamine group with the placebo group (combined across therapy and psychoeducation). Only participants with a minimum of 159 days of completed drinking self-report data were included in the main ITT analysis as this was the shortest duration of time before any participant completed the 6 month (23-25 week) follow up in the study. Reporting time was capped at 180 days.||19.0|1.1|
71025194|NCT00543439|141557645|SUPERIORITY||Ratio of arithmetic means|0.03||||0.002|ONE_SIDED|95.0||0.08|||Paired t-test|||Ratio of the arithmetic means of the ABR for OD cohort: OD therapy to OD cohort: RP therapy 25 IU/kg was calculated. One-sided 95% CI for this ratio was reported.||0.08||0.0020
71025195|NCT00543439|141557646|EQUIVALENCE|90% 2-sided CI for the mean difference in ABRs for the 2 prophylaxis regimens for ITT participants was constructed using the t distribution with n-1 degrees of freedom (n equals the number of participants) to assess the equivalence of the 2 regimens. Equivalence was demonstrated and the null hypothesis rejected if the limits of the 90% CI fell wholly within the interval of (-4, 4) bleeds per year.|Mean Difference (Final Values)|1.1|||||TWO_SIDED|90.0|0.03|2.22||||||||2.22|0.03|
70851857|NCT02034409|141191903|NON_INFERIORITY|For the 48-week cartilage change outcome measure the minimally clinically significant difference is 33 μm. With a difference of 33 μm, σ=152 μm standard deviation, k=2 groups, and P=0.90 probability to obtain τ=1.8124, which we use to estimate the per-group sample size: n=σ2(τ/δ\*)2=72 or a total of 144.||||||||||||||||Sample size has been calculated with ranking and selection methodology, a procedure used for Phase II trials. The purpose of the procedure as applied to this study is to identify whether PLIUS has a high probability of being more effective than sham. This is accomplished by obtaining sample estimates of the outcome for the PLIUS and sham groups and determining whether the PLIUS group outcome is better by the pre-specified margin of difference.|Since the ranking and selection procedures are fundamentally different from traditional hypothesis testing, concepts of statistical significance and power have no direct analogue.|||
70851858|NCT03952039|141191931|SUPERIORITY||Difference in Proportion|29.6|||<|0.0001|TWO_SIDED|95.0|19.9|39.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test using the Greenland and Robins method to adjust for stratification factors: spleen size by palpation and platelet counts.||Stratified analysis (based on CRF)||39.4|19.9|<0.0001
70851859|NCT03952039|141191932|SUPERIORITY|Stratified analysis (based on CRF)|Difference in Proportion|17.1||||0.0033|TWO_SIDED|95.0|4.8|29.4|||Cochran-Mantel-Haenszel|CMH test using the Greenland and Robins method to adjust for stratification factors: spleen size by palpation and platelet counts.||||29.4|4.8|0.0033
70851860|NCT03952039|141191933|SUPERIORITY||Difference in Proportion|33.5|||<|0.0001|TWO_SIDED|95.0|21.9|45.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test using the Greenland and Robins method to adjust for stratification factors: spleen size by palpation and platelet counts.||Stratified analysis (based on CRF)||45.1|21.9|<0.0001
70851861|NCT03952039|141191936|SUPERIORITY||Greenland and Robins method|19.9|||||TWO_SIDED|95.0|10.0|29.7|||Greenland and Robins method|||||29.7|10.0|
70851862|NCT04219085|141191946|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.0
71025196|NCT00891878|141557673|SUPERIORITY|||||||0.43|||||||Log Rank|||||||0.43
71025197|NCT00891878|141557674|SUPERIORITY|||||||0.45|||||||Fisher Exact|||||||0.45
71025198|NCT01200394|141557686|SUPERIORITY||Geometric Mean Ratio|0.843||||0.9889|TWO_SIDED|95.0|0.728|0.975||Posterior distribution was used to calculate a probability (presented as P-value) that PF-00489791 has a greater than 0% reduction in UACR compared to placebo.|ANCOVA||Geometric mean ratio and corresponding 95% credible intervals were calculated.|Analysis of covariance (ANCOVA) model within an outlier robust Bayesian framework on normal logarithmic scale with treatment as fixed effect, baseline UACR and baseline supine systolic blood pressure (BP) as covariate. Values were back-transformed from log scale. Model used informative prior distribution for placebo.||0.975|0.728|0.9889
71025199|NCT01200394|141557686|SUPERIORITY|||||||0.2402|TWO_SIDED|||||Posterior distribution was used to calculate a probability (presented as P-value) that PF-00489791 has a greater than or equal to 20% reduction in UACR compared to placebo.|ANCOVA|||ANCOVA model within an outlier robust Bayesian framework on normal logarithmic scale with treatment as fixed effect, baseline UACR and baseline supine systolic BP as covariate. Values were back-transformed from log scale. Model used informative prior distribution for placebo.||||0.2402
71025200|NCT01200394|141557687|SUPERIORITY||Geometric Mean Ratio|0.8759||||0.0382|TWO_SIDED|95.0|0.7727|0.9927|||Mixed Models Analysis|||Week 3: Mixed model repeated measures (MMRM) on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||0.9927|0.7727|0.0382
71025201|NCT01200394|141557687|SUPERIORITY||Geometric Mean Ratio|0.8311||||0.0112|TWO_SIDED|95.0|0.7208|0.9584|||Mixed Models Analysis|||Week 6: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||0.9584|0.7208|0.0112
71025202|NCT01200394|141557687|SUPERIORITY||Geometric Mean Ratio|0.8816||||0.149|TWO_SIDED|95.0|0.7427|1.0465|||Mixed Models Analysis|||Week 16: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.0465|0.7427|0.1490
71058121|NCT04856917|141621538|SUPERIORITY||LS Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|2.95||0.215|TWO_SIDED|90.0|-1.21|8.56||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||8.56|-1.21|0.2150
71058122|NCT04856917|141621538|SUPERIORITY||LS Mean Difference|5.1|STANDARD_ERROR_OF_MEAN|2.97||0.0864|TWO_SIDED|90.0|0.21|10.05||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||10.05|0.21|0.0864
71025203|NCT01200394|141557688|SUPERIORITY||Geometric Mean Ratio|0.8565||||0.0297|TWO_SIDED|95.0|0.745|0.9847|||Mixed Models Analysis|||Week 3: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||0.9847|0.7450|0.0297
71108449|NCT01214837|141722480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.3|||||TWO_SIDED|95.0|-4.4|4.7|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 4.||4.7|-4.4|
71108450|NCT01214837|141722480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-4.3|||||TWO_SIDED|95.0|-12.1|3.4|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 5.||3.4|-12.1|
71108451|NCT01214837|141722480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|4.9|||||TWO_SIDED|95.0|-1.9|11.8|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 5.||11.8|-1.9|
71108452|NCT01214837|141722480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.04|||||TWO_SIDED|95.0|-3.7|3.8|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 6A.||3.8|-3.7|
71108453|NCT01214837|141722480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|1.2|||||TWO_SIDED|95.0|-2.2|4.8|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 6A.||4.8|-2.2|
71108454|NCT01214837|141722480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-0.3|||||TWO_SIDED|95.0|-8.4|7.7|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 6B.||7.7|-8.4|
71108455|NCT01214837|141722480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|10.2|||||TWO_SIDED|95.0|3.4|17.2|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 6B.||17.2|3.4|
71108456|NCT01214837|141722480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.6|||||TWO_SIDED|95.0|-1.7|3.5|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 7F.||3.5|-1.7|
70934885|NCT01638000|141370306|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.55|STANDARD_ERROR_OF_MEAN|0.866||0.074|TWO_SIDED|95.0|-0.15|3.25||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariates.||Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||3.25|-0.15|0.074
71108457|NCT01214837|141722480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.6|||||TWO_SIDED|95.0|-2.1|3.5|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 7F.||3.5|-2.1|
71108458|NCT01214837|141722480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-3.1|||||TWO_SIDED|95.0|-9.7|3.4|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 9V.||3.4|-9.7|
70851863|NCT04219085|141191947|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
71025204|NCT01200394|141557688|SUPERIORITY||Geometric Mean Ratio|0.8524||||0.0305|TWO_SIDED|95.0|0.7376|0.985|||Mixed Models Analysis|||Week 6: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||0.9850|0.7376|0.0305
71025205|NCT01200394|141557688|SUPERIORITY||Geometric Mean Ratio|0.7937||||0.0068|TWO_SIDED|95.0|0.6717|0.9378|||Mixed Models Analysis|||Week 12: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||0.9378|0.6717|0.0068
71025206|NCT01200394|141557688|SUPERIORITY||Geometric Mean Ratio|0.8634||||0.1151|TWO_SIDED|95.0|0.719|1.0368|||Mixed Models Analysis|||Week 16: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.0368|0.7190|0.1151
71025207|NCT01200394|141557689|SUPERIORITY||Geometric Mean Ratio|0.9816||||0.3585|TWO_SIDED|95.0|0.9434|1.0214|||Mixed Models Analysis|||Week 3: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.0214|0.9434|0.3585
71025208|NCT01200394|141557689|SUPERIORITY||Geometric Mean Ratio|0.9939||||0.7475|TWO_SIDED|95.0|0.9577|1.0315|||Mixed Models Analysis|||Week 6: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.0315|0.9577|0.7475
71025209|NCT01200394|141557689|SUPERIORITY||Geometric Mean Ratio|0.9866||||0.4972|TWO_SIDED|95.0|0.9488|1.0259|||Mixed Models Analysis|||Week 12: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.0259|0.9488|0.4972
71025210|NCT01200394|141557689|SUPERIORITY||Geometric Mean Ratio|1.0024||||0.9146|TWO_SIDED|95.0|0.9588|1.0481|||Mixed Models Analysis|||Week 16: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.0481|0.9588|0.9146
71025211|NCT01200394|141557690|SUPERIORITY||Least Squares (LS) Mean Difference|-5.39|STANDARD_ERROR_OF_MEAN|1.2942|<|0.0001|TWO_SIDED|95.0|-7.94|-2.84|||Mixed Models Analysis|||Supine Systolic BP, Week 0: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||-2.84|-7.94|<0.0001
71025212|NCT01200394|141557690|SUPERIORITY||LS Mean Difference|-3.71|STANDARD_ERROR_OF_MEAN|0.849|<|0.0001|TWO_SIDED|95.0|-5.38|-2.04|||Mixed Models Analysis|||Supine Diastolic BP, Week 0: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||-2.04|-5.38|<0.0001
71025213|NCT01200394|141557690|SUPERIORITY||LS Mean Difference|-4.59|STANDARD_ERROR_OF_MEAN|0.9489|<|0.0001|TWO_SIDED|95.0|-6.46|-2.72|||Mixed Models Analysis|||Supine Mean BP, Week 0: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||-2.72|-6.46|<0.0001
71025214|NCT01200394|141557690|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|1.4056||0.7093|TWO_SIDED|95.0|-3.29|2.24|||Mixed Models Analysis|||Supine Systolic BP, Week 3: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||2.24|-3.29|0.7093
71025215|NCT01200394|141557690|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.9089||0.6564|TWO_SIDED|95.0|-1.39|2.2|||Mixed Models Analysis|||Supine Diastolic BP, Week 3: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||2.20|-1.39|0.6564
71058123|NCT04856917|141621538|SUPERIORITY||LS Mean Difference|10.4|STANDARD_ERROR_OF_MEAN|3.88||0.0084|TWO_SIDED|90.0|3.97|16.85||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||16.85|3.97|0.0084
71058124|NCT04856917|141621538|SUPERIORITY||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|3.91||0.16|TWO_SIDED|90.0|-0.95|12.01||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||12.01|-0.95|0.1600
71058125|NCT04856917|141621538|SUPERIORITY||LS Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|5.23||0.3671|TWO_SIDED|90.0|-3.94|13.41||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||13.41|-3.94|0.3671
71108459|NCT01214837|141722480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|4.0|||||TWO_SIDED|95.0|-1.5|9.7|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 9V.||9.7|-1.5|
70851864|NCT04219085|141191948|SUPERIORITY|||||||0.85|||||||t-test, 2 sided|||||||0.85
70934886|NCT01638000|141370306|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.41|STANDARD_ERROR_OF_MEAN|0.873||0.11|TWO_SIDED|95.0|-0.3|3.12||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariates.||Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||3.12|-0.30|0.11
71108460|NCT01214837|141722480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|vaccine group difference|1.9|||||TWO_SIDED|95.0|-1.2|5.7|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 14.||5.7|-1.2|
71108461|NCT01214837|141722480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|2.5|||||TWO_SIDED|95.0|-0.2|6.3|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 14.||6.3|-0.2|
71108462|NCT01214837|141722480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-2.5|||||TWO_SIDED|95.0|-6.3|-0.2|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 18C.||-0.2|-6.3|
71108463|NCT01214837|141722480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-2.2|||||TWO_SIDED|95.0|-6.2|0.2|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 18C.||0.2|-6.2|
71108464|NCT01214837|141722480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-2.5|||||TWO_SIDED|95.0|-7.1|1.6|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 19A.||1.6|-7.1|
71108465|NCT01214837|141722480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-5.5|||||TWO_SIDED|95.0|-11.3|-0.9|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 19A.||-0.9|-11.3|
71108466|NCT01214837|141722480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.6|||||TWO_SIDED|95.0|-1.7|3.4|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 19F.||3.4|-1.7|
70851865|NCT04473235|141191964|SUPERIORITY||Mean Difference (Final Values)|-0.799|STANDARD_ERROR_OF_MEAN|1.3||0.531|TWO_SIDED||||||t-test, 2 sided|||||||0.531
70941700|NCT04748445|141383934|OTHER||Slope|-1.336|STANDARD_ERROR_OF_MEAN|1.176||0.2584|TWO_SIDED|90.0|-3.285|6.138|||Mixed Models Analysis|||READ\_MFCC std 05 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit, estimated value and dispersion value it was 10\^-2. For upper limit it was 10\^-3).||6.138|-3.285|0.2584
70851866|NCT04473235|141191965|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.627|TWO_SIDED||||||t-test, 2 sided|||Difference in the connectivity between the left hippocampus and left prefrontal cortex.||||0.627
70851867|NCT04473235|141191965|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.12|TWO_SIDED||||||t-test, 2 sided|||Difference in the connectivity between the right hippocampus and right prefrontal cortex.||||0.120
71058126|NCT04856917|141621538|SUPERIORITY||LS Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|5.35||0.1587|TWO_SIDED|90.0|-1.28|16.46||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||16.46|-1.28|0.1587
71058127|NCT04856917|141621538|SUPERIORITY||LS Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|5.8||0.1932|TWO_SIDED|90.0|-2.03|17.21||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||17.21|-2.03|0.1932
71058128|NCT04856917|141621538|SUPERIORITY||LS Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|5.82||0.2518|TWO_SIDED|90.0|-2.95|16.37||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||16.37|-2.95|0.2518
71058129|NCT04856917|141621538|SUPERIORITY||LS Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|5.53||0.232|TWO_SIDED|90.0|-2.53|15.83||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||15.83|-2.53|0.2320
71058130|NCT04856917|141621538|SUPERIORITY||LS Mean Difference|7.1|STANDARD_ERROR_OF_MEAN|5.55||0.2014|TWO_SIDED|90.0|-2.08|16.35||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||16.35|-2.08|0.2014
71058131|NCT04856917|141621539|SUPERIORITY||LS Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|4.94||0.4361|TWO_SIDED|90.0|-4.34|12.06||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||12.06|-4.34|0.4361
71058132|NCT04856917|141621539|SUPERIORITY||LS Mean Difference|8.2|STANDARD_ERROR_OF_MEAN|4.98||0.1018|TWO_SIDED|90.0|-0.04|16.48||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||16.48|-0.04|0.1018
71058133|NCT04856917|141621539|SUPERIORITY||LS Mean Difference|16.3|STANDARD_ERROR_OF_MEAN|5.79||0.0059|TWO_SIDED|90.0|6.66|25.88||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||25.88|6.66|0.0059
71058134|NCT04856917|141621539|SUPERIORITY||LS Mean Difference|9.9|STANDARD_ERROR_OF_MEAN|5.83||0.0913|TWO_SIDED|90.0|0.26|19.59||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||19.59|0.26|0.0913
71058135|NCT04856917|141621539|SUPERIORITY||LS Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|7.7||0.4921|TWO_SIDED|90.0|-7.47|18.09||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||18.09|-7.47|0.4921
71058136|NCT04856917|141621539|SUPERIORITY||LS Mean Difference|11.1|STANDARD_ERROR_OF_MEAN|7.89||0.1607|TWO_SIDED|90.0|-1.95|24.24||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||24.24|-1.95|0.1607
71058137|NCT04856917|141621539|SUPERIORITY||LS Mean Difference|14.2|STANDARD_ERROR_OF_MEAN|9.19||0.1244|TWO_SIDED|90.0|-1.02|29.48||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||29.48|-1.02|0.1244
71058138|NCT04856917|141621539|SUPERIORITY||LS Mean Difference|15.2|STANDARD_ERROR_OF_MEAN|9.2||0.1004|TWO_SIDED|90.0|-0.02|30.51||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||30.51|-0.02|0.1004
71058139|NCT04856917|141621539|SUPERIORITY||LS Mean Difference|12.4|STANDARD_ERROR_OF_MEAN|9.64||0.2015|TWO_SIDED|90.0|-3.61|28.39||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||28.39|-3.61|0.2015
71058140|NCT04856917|141621539|SUPERIORITY||LS Mean Difference|15.8|STANDARD_ERROR_OF_MEAN|9.66||0.1057|TWO_SIDED|90.0|-0.27|31.81||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||31.81|-0.27|0.1057
71108467|NCT01214837|141722480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.6|||||TWO_SIDED|95.0|-2.1|3.4|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 19F.||3.4|-2.1|
71058141|NCT04856917|141621540|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.08||0.5157|TWO_SIDED|90.0|-0.08|0.19||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||0.19|-0.08|0.5157
71058142|NCT04856917|141621540|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.08||0.0178|TWO_SIDED|90.0|0.06|0.34||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||0.34|0.06|0.0178
71058143|NCT04856917|141621540|SUPERIORITY||LS Mean Difference|0.3|STANDARD_DEVIATION|0.12||0.0132|TWO_SIDED|90.0|0.1|0.48||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||0.48|0.10|0.0132
71058144|NCT04856917|141621540|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0034|TWO_SIDED|90.0|0.16|0.54||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||0.54|0.16|0.0034
70851868|NCT01221285|141191994|SUPERIORITY_OR_OTHER||Fold change|1.8||||0.02|TWO_SIDED|95.0|1.1|2.8|||Fold change||Numerator is geometric mean post-baseline IgE. Denominator is baseline IgE.|||2.8|1.1|0.02
70851869|NCT01221285|141191995|SUPERIORITY_OR_OTHER||Fold change|2.5|||<|0.0001|TWO_SIDED|95.0|1.8|3.4|||Fold change||Numerator is geometric mean post-baseline IgG. Denominator is baseline IgG.|||3.4|1.8|<0.0001
70851870|NCT01221285|141191996|SUPERIORITY_OR_OTHER||Fold change|12.9|||<|0.0001|TWO_SIDED|95.0|7.5|22.5|||Fold Change||Numerator is geometric mean post-baseline IgG4. Denominator is baseline IgG4.|||22.5|7.5|<0.0001
70851871|NCT01221285|141191997|SUPERIORITY_OR_OTHER||Change|-42.8|||<|0.0001|TWO_SIDED|95.0|-59.4|-26.2|||Change||Numerator is geometric mean post-baseline FAB. Denominator is baseline FAB.|||-26.2|-59.4|<0.0001
70851872|NCT03861988|141192027|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||||||0.13
70851873|NCT00220779|141192036|SUPERIORITY_OR_OTHER|||||||0.221||||||0.2g/kg IGIV Group versus Placebo|Cochran-Mantel-Haenszel|||The primary efficacy comparison was the comparison of the proportions of relapse free subjects (relapse defined as reported, not necessarily confirmed relapse). The multiple test procedure (hierarchical procedure) was to be stopped as soon as one of the statistical tests resulted in a non-significant P value \> 0.05.||||0.221
70851874|NCT00220779|141192036|SUPERIORITY_OR_OTHER|||||||0.471||||||0.4 g/kg IGIV Group versus Placebo|Cochran-Mantel-Haenszel|||The primary efficacy comparison was the comparison of the proportions of relapse free subjects (relapse defined as reported, not necessarily confirmed relapse). The multiple test procedure (hierarchical procedure) was to be stopped as soon as one of the statistical tests resulted in a non-significant P value \> 0.05.||||0.471
70851875|NCT00281658|141192038|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.0062|TWO_SIDED|95.0|0.58|0.94||Stratified Log-Rank (one-sided)|Log Rank||The treatment hazard ratio based on the proportional hazard model stratifying for metastatic disease sites and hormonal status. A hazard ratio \<1 indicates a lower risk with Lapatinib 1500mg + Paclitaxel compared with Placebo + Paclitaxel.|Primary OS analysis cut-off date = 18-Jun-2010||0.94|0.58|0.0062
70851876|NCT00281658|141192039|OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.64|0.98|||||The treatment hazard ratio based on the proportional hazard model stratifying for metastatic disease sites and hormonal status. A hazard ratio \<1 indicates a lower risk with Lapatinib 1500mg + Paclitaxel compared with Placebo + Paclitaxel.|Final OS analysis cut-0ff date = 23-Nov-2021||0.98|0.64|
71058145|NCT04856917|141621540|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.13||0.051|TWO_SIDED|90.0|0.04|0.47||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||0.47|0.04|0.0510
70851877|NCT00281658|141192040|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.44|0.66|||||The Pike estimator of the treatment hazard ratio based on the log rank test stratifying for metastatic disease sites and hormonal status. A hazard ratio \<1 indicates a lower risk with Lapatinib 1500mg + Paclitaxel compared with Placebo + Paclitaxel.|||0.66|0.44|
70851878|NCT00281658|141192041|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.3|||||TWO_SIDED|95.0|1.54|3.47||||||||3.47|1.54|
70851879|NCT00281658|141192042|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.34|||||TWO_SIDED|95.0|1.54|3.58||||||||3.58|1.54|
70851880|NCT00281658|141192047|OTHER||Odds Ratio (OR)|2.78|||||TWO_SIDED|95.0|1.07|7.57||||||Participants with PIK3CA wild-type||7.57|1.07|
70851881|NCT00281658|141192048|OTHER||Odds Ratio (OR)|2.42|||||TWO_SIDED|95.0|1.28|4.63||||||Participants with PTEN low||4.63|1.28|
70851882|NCT00281658|141192048|OTHER||Odds Ratio (OR)|2.21|||||TWO_SIDED|95.0|1.04|4.82||||||Participants without PTEN low||4.82|1.04|
70851883|NCT00281658|141192050|OTHER||Odds Ratio (OR)|3.15|||||TWO_SIDED|95.0|1.58|6.49||||||Participants with PTEN low||6.49|1.58|
70851884|NCT00281658|141192050|OTHER||Odds Ratio (OR)|2.49|||||TWO_SIDED|95.0|1.13|5.66||||||Participants without PTEN low||5.66|1.13|
71058146|NCT04856917|141621540|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0608|TWO_SIDED|90.0|0.03|0.47||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||0.47|0.03|0.0608
71058147|NCT04856917|141621540|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.17||0.2702|TWO_SIDED|90.0|-0.1|0.48||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||0.48|-0.10|0.2702
71058148|NCT04856917|141621540|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0249|TWO_SIDED|90.0|0.11|0.69||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||0.69|0.11|0.0249
71025216|NCT01200394|141557690|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|1.0334||0.8763|TWO_SIDED|95.0|-2.2|1.87|||Mixed Models Analysis|||Supine Mean BP, Week 3: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||1.87|-2.20|0.8763
71025217|NCT01200394|141557690|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|1.4926||0.7491|TWO_SIDED|95.0|-3.42|2.46|||Mixed Models Analysis|||Supine Systolic BP, Week 6: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||2.46|-3.42|0.7491
70851885|NCT01235598|141192059|SUPERIORITY_OR_OTHER||Median difference within group changes|-1.5||||0.049|TWO_SIDED|95.0|-3.0|0.0||Two-sided p-value is presented, with p \< 0.05 as the threshold for statistical significance.|Permutation test with general scores||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses. Hypotheses were ordered and tested in that order, beginning with change from Baseline at Week 16, and continuing to earlier time points (Week 8, 4, 2, 1 in that order) only if the previous null hypothesis of zero difference was rejected (p \<0.05). Hypothesis testing was stopped if and when a non-significant result was obtained.||0.0|-3.0|0.049
71025218|NCT01200394|141557690|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.9235||0.6141|TWO_SIDED|95.0|-2.29|1.35|||Mixed Models Analysis|||Supine Diastolic BP, Week 6: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||1.35|-2.29|0.6141
71025219|NCT01200394|141557690|SUPERIORITY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|1.0582||0.5281|TWO_SIDED|95.0|-2.75|1.42|||Mixed Models Analysis|||Supine Mean BP, Week 6: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||1.42|-2.75|0.5281
71025220|NCT01200394|141557690|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|1.8764||0.6695|TWO_SIDED|95.0|-2.9|4.5|||Mixed Models Analysis|||Supine Systolic BP, Week 12: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||4.50|-2.90|0.6695
71025221|NCT01200394|141557690|SUPERIORITY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|1.073||0.5607|TWO_SIDED|95.0|-2.74|1.49|||Mixed Models Analysis|||Supine Diastolic BP, Week 12: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||1.49|-2.74|0.5607
71025222|NCT01200394|141557690|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|1.2722||0.8297|TWO_SIDED|95.0|-2.78|2.23|||Mixed Models Analysis|||Supine Mean BP, Week 12: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||2.23|-2.78|0.8297
71025223|NCT01200394|141557690|SUPERIORITY||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|1.7065||0.7644|TWO_SIDED|95.0|-2.85|3.87|||Mixed Models Analysis|||Supine Systolic BP, Week 16: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||3.87|-2.85|0.7644
71025224|NCT01200394|141557690|SUPERIORITY||LS Mean Difference|0.65|STANDARD_ERROR_OF_MEAN|0.9917||0.5123|TWO_SIDED|95.0|-1.3|2.61|||Mixed Models Analysis|||Supine Diastolic BP, Week 16: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||2.61|-1.30|0.5123
71025225|NCT01200394|141557690|SUPERIORITY||LS Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|1.1355||0.6838|TWO_SIDED|95.0|-1.77|2.7|||Mixed Models Analysis|||Supine Mean BP, Week 16: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||2.70|-1.77|0.6838
71025226|NCT01200394|141557692|SUPERIORITY||Geometric Mean Ratio|0.9282||||0.5422|TWO_SIDED|95.0|0.7297|1.1807|||Mixed Models Analysis|||Week 3: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.1807|0.7297|0.5422
71058149|NCT04856917|141621540|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.18||0.1853|TWO_SIDED|90.0|-0.06|0.55||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||0.55|-0.06|0.1853
70941701|NCT04748445|141383934|OTHER||Slope|-0.006497|STANDARD_ERROR_OF_MEAN|1.413||0.6465|TWO_SIDED|90.0|-0.02992|0.01692|||Mixed Models Analysis|||READ\_MFCC std 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.01692|-0.02992|0.6465
71025227|NCT01200394|141557692|SUPERIORITY||Geometric Mean Ratio|0.7998||||0.049|TWO_SIDED|95.0|0.6402|0.999|||Mixed Models Analysis|||Week 6: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||0.9990|0.6402|0.0490
70934887|NCT01638000|141370307|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.07|TWO_SIDED|95.0|-0.19|0.01||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 4 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||0.01|-0.19|0.070
70934888|NCT01638000|141370307|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.054||0.003|TWO_SIDED|95.0|-0.27|-0.06||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 8 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.06|-0.27|0.003
70934889|NCT01638000|141370307|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.06||0.015|TWO_SIDED|95.0|-0.26|-0.03||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 12 Difference vs. Mirabegron.Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.03|-0.26|0.015
70934890|NCT01638000|141370307|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.059||0.021|TWO_SIDED|95.0|-0.25|-0.02||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.02|-0.25|0.021
71025228|NCT01200394|141557692|SUPERIORITY||Geometric Mean Ratio|1.0435||||0.7264|TWO_SIDED|95.0|0.8211|1.3262|||Mixed Models Analysis|||Week 12: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.3262|0.8211|0.7264
71058150|NCT04856917|141621540|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.18||0.2974|TWO_SIDED|90.0|-0.11|0.5||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||0.50|-0.11|0.2974
71025229|NCT01200394|141557692|SUPERIORITY||Geometric Mean Ratio|1.1154||||0.3733|TWO_SIDED|95.0|0.8761|1.4201|||Mixed Models Analysis|||Week 16: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.4201|0.8761|0.3733
71025230|NCT02100956|141557715|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Null hypothesis was that there was no difference in VAS pain scale scores after intrathecal study drug injection between oxytocin and placebo. To account for repeated measures across time and drug conditions, VAS apin scale scores were analyzed using a linear mixed-effects model with random intercepts at the level of participant. Each outcome was regressed on fixed-effects for order of study day, study drug, time after injection, and drug x time interaction.||||<0.05
71025231|NCT02473991|141557732|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Regression, Linear|||Null hypothesis In normal pregnant women, placental thickness during second trimesters may be correlated with birth weight at term.||||<0.01
71025232|NCT02473991|141557733|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Regression, Linear|||Null hypothesis In normal pregnant women, placental thickness during third trimesters may be correlated with birth weight at term.||||<0.01
71025233|NCT03065283|141557743|EQUIVALENCE|p\< or = 0.05|Mean Difference (Final Values)|0.09||||0.05|TWO_SIDED|95.0|-0.38|0.57|||t-test, 2 sided|||A paired t-test was used for intragroup analysis, and an independent Student's t-test was used for intergroup analysis. Data are represented in mean between-group difference with a 95% CI, and analysis was by intention to treat.||0.57|-0.38|0.05
71025234|NCT00095199|141557747|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.756|TWO_SIDED|95.0|0.87|1.21||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|Kaplan-Meier method estimated median PFS time. HR was calculated with unstratified Cox proportional hazards model. HR\<1 favours Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.21|0.87|0.756
71058151|NCT04856917|141621541|SUPERIORITY||Risk Difference (RD)|-2.5||||0.339|TWO_SIDED|90.0|-6.62|1.63||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 400/200 mg vs Placebo: Week 4||1.63|-6.62|0.3390
71058152|NCT04856917|141621541|SUPERIORITY||Risk Difference (RD)|-2.6||||0.3243|TWO_SIDED|90.0|-6.79|1.59||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 200/100 mg vs Placebo: Week 4||1.59|-6.79|0.3243
71108468|NCT01214837|141722480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|1.9|||||TWO_SIDED|95.0|-4.2|8.2|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 23F.||8.2|-4.2|
71108469|NCT01214837|141722480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|4.5|||||TWO_SIDED|95.0|-1.4|10.5|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 23F.||10.5|-1.4|
71108470|NCT01214837|141722481|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.94|||||TWO_SIDED|95.0|0.77|1.13|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 1.||1.13|0.77|
71108471|NCT01214837|141722481|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.02|||||TWO_SIDED|95.0|0.83|1.25|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 1.||1.25|0.83|
71108472|NCT01214837|141722481|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|1.14|||||TWO_SIDED|95.0|0.93|1.4|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 3.||1.4|0.93|
71108473|NCT01214837|141722481|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.25|||||TWO_SIDED|95.0|1.01|1.55|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 3.||1.55|1.01|
71108474|NCT01214837|141722481|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.77|||||TWO_SIDED|95.0|0.62|0.96|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 4.||0.96|0.62|
71108475|NCT01214837|141722481|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|0.94|||||TWO_SIDED|95.0|0.75|1.18|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 4.||1.18|0.75|
71108476|NCT01214837|141722481|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|1.02|||||TWO_SIDED|95.0|0.86|1.21|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 5.||1.21|0.86|
71108477|NCT01214837|141722481|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5|GMC ratio|1.07|||||TWO_SIDED|95.0|0.89|1.29|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 5.||1.29|0.89|
71108478|NCT01214837|141722481|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.85|||||TWO_SIDED|95.0|0.69|1.04|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 6A.||1.04|0.69|
70934891|NCT01638000|141370308|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.43|STANDARD_ERROR_OF_MEAN|0.141||0.002|TWO_SIDED|95.0|0.15|0.7||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||0.70|0.15|0.002
71108479|NCT01214837|141722481|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.1|||||TWO_SIDED|95.0|0.88|1.37|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 6A.||1.37|0.88|
70934892|NCT01638000|141370308|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.141||0.003|TWO_SIDED|95.0|0.14|0.7||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||0.70|0.14|0.003
70934893|NCT01638000|141370309|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean diffrence|0.16|STANDARD_ERROR_OF_MEAN|0.07||0.027|TWO_SIDED|95.0|0.02|0.29||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||0.29|0.02|0.027
70934894|NCT01638000|141370309|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.071||0.034|TWO_SIDED|95.0|0.01|0.29||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||0.29|0.01|0.034
70934895|NCT01638000|141370310|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.4||||0.01|TWO_SIDED|95.0|1.08|1.81||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron||1.81|1.08|0.010
70934896|NCT01638000|141370310|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.011|TWO_SIDED|95.0|1.07|1.75||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron||1.75|1.07|0.011
70934897|NCT01638000|141370311|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.28||||0.037|TWO_SIDED|95.0|1.02|1.62||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron||1.62|1.02|0.037
70934898|NCT01638000|141370311|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.26||||0.045|TWO_SIDED|95.0|1.01|1.57||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron||1.57|1.01|0.045
70934899|NCT01638000|141370312|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.51||||0.009|TWO_SIDED|95.0|1.11|2.06||Iif p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 (≥1 point improvement) Odds Rato vs. Mirabegron||2.06|1.11|0.009
71025235|NCT00095199|141557747|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.391|TWO_SIDED|95.0|0.73|1.13||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|Kaplan-Meier method estimated median PFS time. HR was calculated with unstratified Cox proportional hazards model. HR\<1 favours Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.13|0.73|0.391
71025236|NCT00095199|141557748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.864|TWO_SIDED|95.0|0.86|1.2||The 2-sided unstratified log-rank test was employed at the 5% significance level|Log Rank|Kaplan-Meier method estimated median OS time. HR was calculated with unstratified Cox proportional hazards model. HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.20|0.86|0.864
71025237|NCT00095199|141557748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.307|TWO_SIDED|95.0|0.9|1.41||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|Kaplan-Meier method estimated median OS time. HR was calculated with unstratified Cox proportional hazards model. HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.41|0.90|0.307
71025238|NCT00095199|141557749|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.2|TWO_SIDED|95.0|0.78|3.26||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||3.26|0.78|0.200
71025239|NCT00095199|141557749|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.683|TWO_SIDED|95.0|0.52|2.74||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||2.74|0.52|0.683
71108480|NCT01214837|141722481|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.85|||||TWO_SIDED|95.0|0.69|1.05|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 6B.||1.05|0.69|
71108481|NCT01214837|141722481|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.04|||||TWO_SIDED|95.0|0.83|1.3|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 6B.||1.3|0.83|
71058153|NCT04856917|141621541|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|90.0|-5.91|5.91||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 400/200 mg vs Placebo: Week 8||5.91|-5.91|1.0000
71058154|NCT04856917|141621541|SUPERIORITY||Risk Difference (RD)|-2.66||||0.332|TWO_SIDED|90.0|-6.96|1.63||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 200/100 mg vs Placebo: Week 8||1.63|-6.96|0.3320
71058155|NCT04856917|141621541|SUPERIORITY||Risk Difference (RD)|-2.45||||0.7595|TWO_SIDED|90.0|-15.5|10.59||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 400/200 mg vs Placebo: Week 12||10.59|-15.50|0.7595
71058156|NCT04856917|141621541|SUPERIORITY||Risk Difference (RD)|-14.11||||0.0209|TWO_SIDED|90.0|-23.66|-4.57||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 200/100 mg vs Placebo: Week 12||-4.57|-23.66|0.0209
71058157|NCT04856917|141621541|SUPERIORITY||Risk Difference (RD)|-4.56||||0.6094|TWO_SIDED|90.0|-18.99|9.87||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 400/200 mg vs Placebo: Week 20||9.87|-18.99|0.6094
71058158|NCT04856917|141621541|SUPERIORITY||Risk Difference (RD)|-10.28||||0.2076|TWO_SIDED|90.0|-23.34|2.78||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 200/100 mg vs Placebo: Week 20||2.78|-23.34|0.2076
71058159|NCT04856917|141621542|SUPERIORITY||Risk Difference (RD)|0.1||||0.4482|TWO_SIDED|90.0|-0.1|0.29||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 2||0.29|-0.10|0.4482
71058160|NCT04856917|141621542|SUPERIORITY||Risk Difference (RD)|0.14||||0.4529|TWO_SIDED|90.0|-0.05|0.33||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 2||0.33|-0.05|0.4529
71058161|NCT04856917|141621542|SUPERIORITY||Risk Difference (RD)|-0.01||||0.932|TWO_SIDED|90.0|-0.2|0.18||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 4||0.18|-0.20|0.9320
71058162|NCT04856917|141621542|SUPERIORITY||Risk Difference (RD)|-0.03||||0.3151|TWO_SIDED|90.0|-0.22|0.16||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 4||0.16|-0.22|0.3151
70934900|NCT01638000|141370312|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.065|TWO_SIDED|95.0|0.99|1.65||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 (≥2 point improvement) Odds Rato vs. Mirabegron||1.65|0.99|0.065
70934901|NCT01638000|141370312|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.051|TWO_SIDED|95.0|1.0|1.55||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 (≥3 point improvement) Odds Rato vs. Mirabegron||1.55|1.00|0.051
70934902|NCT01638000|141370312|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.18||||0.14|TWO_SIDED|95.0|0.95|1.47||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 (≥4 point improvement) Odds Rato vs. Mirabegron||1.47|0.95|0.14
70934903|NCT01638000|141370312|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.02||||0.89|TWO_SIDED|95.0|0.75|1.4||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 (≥5 point improvement) Odds Rato vs. Mirabegron||1.40|0.75|0.89
70934904|NCT01638000|141370312|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.14||||0.66|TWO_SIDED|95.0|0.64|2.04||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.|Participants from Canada were therefore excluded from this analysis due to low participant numbers.|Week 12 (6 point improvement) Odds Rato vs. Mirabegron||2.04|0.64|0.66
70934905|NCT01638000|141370313|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.44||||0.016|TWO_SIDED|95.0|1.07|1.93||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit (≥1 point improvement) Odds Rato vs. Mirabegron||1.93|1.07|0.016
70934906|NCT01638000|141370313|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.063|TWO_SIDED|95.0|0.99|1.62||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit (≥2 point improvement) Odds Rato vs. Mirabegron||1.62|0.99|0.063
70941702|NCT04748445|141383934|OTHER||Slope|-1.213|STANDARD_ERROR_OF_MEAN|7.7||0.1177|TWO_SIDED|90.0|-2.489|6.297|||Mixed Models Analysis|||READ\_MFCC std 07 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit and estimated value it was 10\^-2. For dispersion value it was 10\^-3 and for upper limit it was 10\^-4).||6.297|-2.489|0.1177
71058163|NCT04856917|141621542|SUPERIORITY||Risk Difference (RD)|-0.14||||0.2908|TWO_SIDED|90.0|-0.32|0.06||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 8||0.06|-0.32|0.2908
71058164|NCT04856917|141621542|SUPERIORITY||Risk Difference (RD)|0.05||||0.7277|TWO_SIDED|90.0|-0.15|0.24||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 8||0.24|-0.15|0.7277
71058165|NCT04856917|141621542|SUPERIORITY||Risk Difference (RD)|-0.03||||0.8463|TWO_SIDED|90.0|-0.23|0.17||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 12||0.17|-0.23|0.8463
71058166|NCT04856917|141621542|SUPERIORITY||Risk Difference (RD)|-0.08||||0.5281|TWO_SIDED|90.0|-0.28|0.11||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 12||0.11|-0.28|0.5281
71058167|NCT04856917|141621542|SUPERIORITY||Risk Difference (RD)|-0.09||||0.5747|TWO_SIDED|90.0|-0.28|0.11||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 20||0.11|-0.28|0.5747
71058168|NCT04856917|141621542|SUPERIORITY||Risk Difference (RD)|-0.05||||0.5081|TWO_SIDED|90.0|-0.24|0.14||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 20||0.14|-0.24|0.5081
71058169|NCT04856917|141621543|SUPERIORITY||Risk Difference (RD)|0.01||||0.8338|TWO_SIDED|90.0|-0.19|0.2||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 2||0.20|-0.19|0.8338
71058170|NCT04856917|141621543|SUPERIORITY||Risk Difference (RD)|-0.12||||0.1142|TWO_SIDED|90.0|-0.31|0.09||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 2||0.09|-0.31|0.1142
71058171|NCT04856917|141621543|SUPERIORITY||Risk Difference (RD)|-0.2||||0.3433|TWO_SIDED|90.0|-0.38|0.0||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 4||0.00|-0.38|0.3433
71058172|NCT04856917|141621543|SUPERIORITY||Risk Difference (RD)|-0.17||||0.1129|TWO_SIDED|90.0|-0.37|0.04||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 2||0.04|-0.37|0.1129
71108482|NCT01214837|141722481|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.8|||||TWO_SIDED|95.0|0.67|0.95|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 7F.||0.95|0.67|
71108483|NCT01214837|141722481|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.04|||||TWO_SIDED|95.0|0.87|1.25|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 7F.||1.25|0.87|
71108484|NCT01214837|141722481|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.79|||||TWO_SIDED|95.0|0.66|0.96|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 9V.||0.96|0.66|
71108485|NCT01214837|141722481|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.07|||||TWO_SIDED|95.0|0.87|1.31|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 9V.||1.31|0.87|
71108486|NCT01214837|141722481|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|1.03|||||TWO_SIDED|95.0|0.84|1.27|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 14.||1.27|0.84|
71108487|NCT01214837|141722481|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.04|||||TWO_SIDED|95.0|0.83|1.3|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 14.||1.3|0.83|
71108488|NCT01214837|141722481|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.72|||||TWO_SIDED|95.0|0.59|0.87|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 18C.||0.87|0.59|
71108489|NCT01214837|141722481|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.1|||||TWO_SIDED|95.0|0.89|1.36|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 18C.||1.36|0.89|
71108490|NCT01214837|141722481|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|1.02|||||TWO_SIDED|95.0|0.83|1.27|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 19A.||1.27|0.83|
71025240|NCT00095199|141557750|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.31|TWO_SIDED|95.0|0.86|1.62||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.62|0.86|0.310
71058173|NCT04856917|141621543|SUPERIORITY||Risk Difference (RD)|-0.2||||0.2842|TWO_SIDED|90.0|-0.38|0.0||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 8||0.00|-0.38|0.2842
71058174|NCT04856917|141621543|SUPERIORITY||Risk Difference (RD)|-0.34||||0.0212|TWO_SIDED|90.0|-0.52|-0.13||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 8||-0.13|-0.52|0.0212
71058175|NCT04856917|141621543|SUPERIORITY||Risk Difference (RD)|-0.07||||0.7665|TWO_SIDED|90.0|-0.28|0.14||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 12||0.14|-0.28|0.7665
71058176|NCT04856917|141621543|SUPERIORITY||Risk Difference (RD)|-0.22||||0.1777|TWO_SIDED|90.0|-0.42|0.0||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 12||-0.00|-0.42|0.1777
70851886|NCT01235598|141192060|SUPERIORITY_OR_OTHER||Median Difference within group changes|-1.0||||0.206|TWO_SIDED|95.0|-3.0|1.0||Two-sided p-value is presented, with p \< 0.05 as the threshold for statistical significance. A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses.|Permutation test with general scores||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses. Hypotheses were ordered and tested in that order, beginning with change from Baseline at Week 16, and continuing to earlier time points (Week 8, 4, 2, 1 in that order) only if the previous null hypothesis of zero difference was rejected (p \< 0.05). Hypothesis testing was stopped if and when a non-significant result was obtained. Testing was stopped in the next step.||1.0|-3.0|0.206
70851887|NCT01235598|141192064|SUPERIORITY_OR_OTHER||Median difference within group changes|-0.0035||||0.164|TWO_SIDED|95.0|-0.012|0.0025||Two-sided p-value is presented, with p \<0.05 as the threshold for statistical significance. A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses.|Permutation test with general scores||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses. Hypotheses were ordered and tested in that order, beginning with change from Baseline at Week 16, and continuing to earlier time points (Week 8, 4, 2, 1 in that order) only if the previous null hypothesis of zero difference was rejected (p \<0.05). Hypothesis testing was stopped if and when a non-significant result was obtained.||0.0025|-0.0120|0.164
70851888|NCT01235598|141192065|SUPERIORITY_OR_OTHER||Median difference within group changes|-0.069||||0.865|TWO_SIDED|95.0|-0.201|0.138||Two-sided p-value is presented, with p \<0.05 as the threshold for statistical significance. A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses.|Permutation test with general scores||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses. Hypotheses were ordered and tested in that order, beginning with change from Baseline at Week 16, and continuing to earlier time points (Week 8, 4, 2, 1 in that order) only if the previous null hypothesis of zero difference was rejected (p \<0.05). Hypothesis testing was stopped if and when a non-significant result was obtained.||0.1380|-0.2010|0.865
70851889|NCT01235598|141192066|SUPERIORITY_OR_OTHER||Median difference within group changes|-421.5||||0.015|TWO_SIDED|95.0|-1542.5|-47.0||Two-sided p-value is presented, with p \<0.05 as the threshold for statistical significance. A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses.|Permutation test with general scores||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses. Hypotheses were ordered and tested in that order, beginning with change from Baseline at Week 16, and continuing to earlier time points (Week 8, 4, 2, 1 in that order) only if the previous null hypothesis of zero difference was rejected (p \<0.05). Hypothesis testing was stopped if and when a non-significant result was obtained.||-47.0|-1542.5|0.015
70851890|NCT01235598|141192078|SUPERIORITY_OR_OTHER|||||||0.394|||||||Spearman rank correlation|||||||0.394
70851891|NCT01235598|141192079|SUPERIORITY_OR_OTHER|||||||0.625|TWO_SIDED||||||Spearman rank correlation|||||||0.625
70851892|NCT01235598|141192080|SUPERIORITY_OR_OTHER|||||||0.128|TWO_SIDED||||||Spearman rank correlation|||||||0.128
70851893|NCT01235598|141192081|SUPERIORITY_OR_OTHER|||||||0.732|TWO_SIDED||||||Spearman rank correlation|||||||0.732
70851894|NCT01235598|141192082|SUPERIORITY_OR_OTHER|||||||0.411|TWO_SIDED||||||Spearman rank correlation|||||||0.411
70851895|NCT01235598|141192083|SUPERIORITY_OR_OTHER|||||||0.208|TWO_SIDED||||||Spearman rank correlation|||||||0.208
70851896|NCT01235598|141192084|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.254|TWO_SIDED|95.0|-1.0|0.0||Two-sided p-value is presented, with p \<0.05 as the threshold for statistical significance.|Wilcoxon Rank-Sum Test||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|||0.0|-1.0|0.254
71025241|NCT00095199|141557750|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.1|TWO_SIDED|95.0|0.93|2.4||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||2.40|0.93|0.100
71025242|NCT00095199|141557751|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.091|TWO_SIDED|95.0|0.46|1.06||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.06|0.46|0.091
71025243|NCT00095199|141557751|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.361|TWO_SIDED|95.0|0.72|2.5||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||2.50|0.72|0.361
71025244|NCT00095199|141557752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.472|TWO_SIDED|95.0|0.77|1.74||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|Kaplan-Meier estimated time to symptomatic progression. HR was calculated using unstratified Cox proportional hazards model. HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.74|0.77|0.472
71025245|NCT00095199|141557752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.272|TWO_SIDED|95.0|0.42|1.27||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|Kaplan-Meier estimated time to symptomatic progression. HR was calculated using unstratified Cox proportional hazards model. HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.27|0.42|0.272
71025246|NCT00095199|141557753|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.58||||0.236|TWO_SIDED|95.0|0.74|3.36||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|The Kaplan-Meier method estimated duration of response. HR was calculated using unstratified Cox proportional hazards model. HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||3.36|0.74|0.236
71025247|NCT00095199|141557753|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.887|TWO_SIDED|95.0|0.42|2.18||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|The Kaplan-Meier method estimated duration of response. HR was calculated using unstratified Cox proportional hazards model. HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||2.18|0.42|0.887
71025248|NCT01070394|141557771|SUPERIORITY_OR_OTHER||||||<|0.001|||||||GEE regression model|Generalized Estimating Equation (GEE)||||||<.001
71025249|NCT01070394|141557772|SUPERIORITY_OR_OTHER|||||||0.569|||||||GEE regression model|Generalized Estimating Equation (GEE)||||||.569
71025250|NCT01070394|141557772|SUPERIORITY_OR_OTHER|||||||0.827|||||||Generalized Estimating Equation|||The following p-value is for AMSES In-Clinic, a subset of the overall AMSES||||.827
71025251|NCT01070394|141557772|SUPERIORITY_OR_OTHER|||||||0.569|||||||Generalized Estimating Equation|||The following p-value is for AMSES, Evening, a subset of the AMSES||||.569
71025252|NCT01070394|141557773|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||GEE regression model|Generalized Estimating Equation (GEE)||||||.001
71025253|NCT01070394|141557774|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||GEE regression model|||||||<.001
71025254|NCT01070394|141557775|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||GEE regression model|Generalized Estimating Equation (GEE)||||||<.0001
71025255|NCT01070394|141557776|SUPERIORITY_OR_OTHER|||||||0.001|||||||GEE regression model|Generalized Estimating Equation (GEE)||||||0.001
71025256|NCT00634283|141557779|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
71025257|NCT00634283|141557779|SUPERIORITY|||||||0.32||||||The a priori threshold was set at 0.05, 2-tailed, without adjustment for multiple comparisons.|t-test, 2 sided|||Change in PFC over the one-week placebo lead-in period was compared between antidepressant-experienced and antidepressant-naive groups using a between groups t-test.|"Group differences in PFC changes over time during administration of venlafaxine were assessed using mixed-model analysis.~we compared brain functional changes over the course of venlafaxine treatment between antidepressant-experienced and antidepressant-naïve subjects using linear mixed model analysis (random intercept model) conducted using full maximum likelihood estimation (MLE). Changes in PFC were calculated from the end of placebo lead-in to 48 hours, and 1, 2, and 4 weeks, yielding a within-group factor of time with four levels. We employed a first-order autoregressive covariance structure to reflect our assumption that PFC measurements closer together in time would be more highly correlated."|||0.32
71025258|NCT03118739|141557781|SUPERIORITY||Mean % Change from Baseline|-39.37|||||TWO_SIDED|90.0|-61.785|-3.814||||||||-3.814|-61.785|
71025259|NCT00461500|141557942|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.23|STANDARD_ERROR_OF_MEAN|17.6||0.683||95.0|-27.96|42.43|||ANCOVA||mean difference = drug SFC 100 minus FP 100|||42.43|-27.96|0.683
71025260|NCT01806597|141557955|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|19.3||||0.0002|TWO_SIDED|95.0|2.4|154.6|||Cochran-Mantel-Haenszel|||Data at Week 16 was analyzed using the stratified Cochran-Mantel-Haenszel-test. The test was stratified by body-weight category (\<90 kg or ≥90 kg).||154.6|2.4|0.0002
71025261|NCT01806597|141557955|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|29.4|||<|0.0001|TWO_SIDED|95.0|4.1|211.9|||Cochran-Mantel-Haenszel|||Data at Week 16 was analyzed using the stratified Cochran-Mantel-Haenszel-test. The test was stratified by body-weight category (\<90 kg or ≥90 kg).||211.9|4.1|<0.0001
71025262|NCT02247479|141557965|SUPERIORITY||Difference in Adjusted Means|-0.019||||0.8381|TWO_SIDED|95.0|-0.206|0.167|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.167|-0.206|0.8381
71025263|NCT02247479|141557965|SUPERIORITY||Difference in Adjusted Means|0.051||||0.5901|TWO_SIDED|95.0|-0.134|0.236|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.236|-0.134|0.5901
71025264|NCT02247479|141557966|SUPERIORITY||Difference in Adjusted Means|-0.2||||0.935|TWO_SIDED|95.0|-5.2|4.8|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline number of absolute scotomatous points, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||4.8|-5.2|0.9350
71025265|NCT02247479|141557966|SUPERIORITY||Difference in Adjusted Means|0.1||||0.9789|TWO_SIDED|95.0|-5.0|5.2|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline number of absolute scotomatous points, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||5.2|-5.0|0.9789
70851897|NCT01235598|141192085|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.472|TWO_SIDED|95.0|-2.0|1.0||Two-sided p-value is presented, with p \<0.05 as the threshold for statistical significance.|Wilcoxon Rank-Sum Test||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|||1.0|-2.0|0.472
70934907|NCT01638000|141370313|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.24||||0.054|TWO_SIDED|95.0|1.0|1.53||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit (≥3 point improvement) Odds Rato vs. Mirabegron||1.53|1.00|0.054
71025266|NCT02247479|141557967|SUPERIORITY||Difference in Adjusted Means|0.28||||0.5538|TWO_SIDED|95.0|-0.66|1.22|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline mean macular sensitivity, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||1.22|-0.66|0.5538
71025267|NCT02247479|141557967|SUPERIORITY||Difference in Adjusted Means|-0.63||||0.2032|TWO_SIDED|95.0|-1.6|0.35|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline mean macular sensitivity, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.35|-1.60|0.2032
71025268|NCT02247479|141557968|SUPERIORITY||Difference in Adjusted Means|1.0||||0.2547|TWO_SIDED|95.0|-0.7|2.8|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline BCVA, GA lesion location, biomarker status, and sex.||2.8|-0.7|0.2547
71025269|NCT02247479|141557968|SUPERIORITY||Difference in Adjusted Means|-0.2||||0.8423|TWO_SIDED|95.0|-1.9|1.6|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline BCVA, GA lesion location, biomarker status, and sex.||1.6|-1.9|0.8423
71025270|NCT02247479|141557969|SUPERIORITY||Odds Ratio (OR)|1.3||||0.3248|TWO_SIDED|95.0|0.8|2.2|||Regression, Logistic|||Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline BCVA, baseline GA lesion location, biomarker status, and sex.||2.2|0.8|0.3248
71025271|NCT02247479|141557969|SUPERIORITY||Odds Ratio (OR)|1.1||||0.7209|TWO_SIDED|95.0|0.7|1.8|||Regression, Logistic|||Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline BCVA, baseline GA lesion location, biomarker status, and sex.||1.8|0.7|0.7209
71025272|NCT02247479|141557970|SUPERIORITY||Difference in Adjusted Means|0.6||||0.5695|TWO_SIDED|95.0|-1.4|2.6|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline LLVA, GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.||2.6|-1.4|0.5695
71025273|NCT02247479|141557970|SUPERIORITY||Difference in Adjusted Means|0.3||||0.7865|TWO_SIDED|95.0|-1.7|2.3|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline LLVA, GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.||2.3|-1.7|0.7865
71025274|NCT02247479|141557971|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9448|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|||Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline LLVA, baseline GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.||1.7|0.6|0.9448
71058177|NCT04856917|141621543|SUPERIORITY||Risk Difference (RD)|-0.12||||0.3741|TWO_SIDED|90.0|-0.33|0.09||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 20||0.09|-0.33|0.3741
71058178|NCT04856917|141621543|SUPERIORITY||Risk Difference (RD)|-0.13||||0.3321|TWO_SIDED|90.0|-0.33|0.09||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 20||0.09|-0.33|0.3321
70851898|NCT00395343|141192088|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56|||<|0.001||95.0|-0.7|-0.42|||ANCOVA|Model terms: treatment; baseline; metformin stratum (on vs. not on metformin); insulin stratum (pre-mixed vs. intermediate or long-acting)||||-0.42|-0.70|<0.001
70934908|NCT01638000|141370313|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17||||0.15|TWO_SIDED|95.0|0.95|1.46||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit (≥4 point improvement) Odds Rato vs. Mirabegron||1.46|0.95|0.15
71025275|NCT02247479|141557971|SUPERIORITY||Odds Ratio (OR)|1.0||||0.8764|TWO_SIDED|95.0|0.6|1.8|||Regression, Logistic|||Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline LLVA, baseline GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.||1.8|0.6|0.8764
70851899|NCT00395343|141192089|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.0|||<|0.001||95.0|-23.4|-6.5|||ANCOVA|Model terms: treatment; baseline; metformin stratum; insulin stratum||||-6.5|-23.4|<0.001
71025276|NCT02247479|141557972|SUPERIORITY||Difference in Adjusted Means|5.66||||0.0991|TWO_SIDED|95.0|-1.07|12.38|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, type of reading charts, baseline BCVA of better seeing eye, biomarker status, and sex.||12.38|-1.07|0.0991
71025277|NCT02247479|141557972|SUPERIORITY||Difference in Adjusted Means|-0.99||||0.7713|TWO_SIDED|95.0|-7.66|5.69|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, type of reading charts, baseline BCVA of better seeing eye, biomarker status, and sex.||5.69|-7.66|0.7713
71025278|NCT02247479|141557973|SUPERIORITY||Difference in Adjusted Means|1.72||||0.6204|TWO_SIDED|95.0|-5.09|8.53|||MMRM|||MMRM analysis uses change as response variable included terms for treatment group, baseline maximum reading speed, type of reading charts, biomarker status, modified baseline BCVA and sex.||8.53|-5.09|0.6204
71058179|NCT04856917|141621544|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.11||0.7932|TWO_SIDED|90.0|-1.56|2.14||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||2.14|-1.56|0.7932
70934909|NCT01638000|141370313|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||0.75|TWO_SIDED|95.0|0.77|1.44||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit (≥5 point improvement) Odds Rato vs. Mirabegron||1.44|0.77|0.75
70934910|NCT01638000|141370313|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.14||||0.66|TWO_SIDED|95.0|0.64|2.04||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.|Participants from Canada were therefore excluded from this analysis due to low participant numbers.|Final visit (6 point improvement) Odds Rato vs. Mirabegron||2.04|0.64|0.66
71058180|NCT04856917|141621544|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.12||0.4365|TWO_SIDED|90.0|-0.99|2.73||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||2.73|-0.99|0.4365
71058181|NCT04856917|141621544|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.04||0.8543|TWO_SIDED|90.0|-1.92|1.54||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||1.54|-1.92|0.8543
71058182|NCT04856917|141621544|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.05||0.8726|TWO_SIDED|90.0|-1.91|1.58||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||1.58|-1.91|0.8726
71108491|NCT01214837|141722481|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|0.97|||||TWO_SIDED|95.0|0.77|1.21|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 19A.||1.21|0.77|
71108492|NCT01214837|141722481|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|1.0|||||TWO_SIDED|95.0|0.82|1.22|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 19F.||1.22|0.82|
71108493|NCT01214837|141722481|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.07|||||TWO_SIDED|95.0|0.86|1.32|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 19F.||1.32|0.86|
70934911|NCT01638000|141370314|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.24||||0.082|TWO_SIDED|95.0|0.97|1.57||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron||1.57|0.97|0.082
70851900|NCT00395343|141192090|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-36.1|||<|0.001||95.0|-47.1|-25.1|||ANCOVA|Model terms: treatment; baseline; metformin stratum; insulin stratum||||-25.1|-47.1|<0.001
70934912|NCT01638000|141370314|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.18||||0.15|TWO_SIDED|95.0|0.94|1.49||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron||1.49|0.94|0.15
70934913|NCT01638000|141370315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.23||||0.058|TWO_SIDED|95.0|0.99|1.53||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron||1.53|0.99|0.058
70934914|NCT01638000|141370315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.21||||0.069|TWO_SIDED|95.0|0.99|1.5||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visitI|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron||1.50|0.99|0.069
70941703|NCT04748445|141383934|OTHER||Slope|-0.007959|STANDARD_ERROR_OF_MEAN|9.743||0.4155|TWO_SIDED|90.0|-0.02411|0.008187|||Mixed Models Analysis|||READ\_MFCC std 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.008187|-0.02411|0.4155
71058183|NCT04856917|141621544|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.07||0.5983|TWO_SIDED|90.0|-1.22|2.35||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||2.35|-1.22|0.5983
70851901|NCT00395343|141192091|SUPERIORITY_OR_OTHER||Geometric Mean Difference|36.5||||0.01||95.0|8.9|64.7|||ANCOVA|Model terms: treatment; log-scaled baseline value; metformin stratum; insulin stratum||||64.7|8.9|0.01
71025279|NCT02247479|141557973|SUPERIORITY||Difference in Adjusted Means|1.47||||0.6705|TWO_SIDED|95.0|-5.31|8.25|||MMRM|||MMRM analysis uses change as response variable included terms for treatment group, baseline maximum reading speed, type of reading charts, biomarker status, modified baseline BCVA and sex.||8.25|-5.31|0.6705
71058184|NCT04856917|141621544|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.09||0.3396|TWO_SIDED|90.0|-0.77|2.86||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||2.86|-0.77|0.3396
71058185|NCT04856917|141621544|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.97||0.5305|TWO_SIDED|90.0|-2.23|1.01||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||1.01|-2.23|0.5305
71058186|NCT04856917|141621544|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.96||0.0819|TWO_SIDED|90.0|0.09|3.29||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||3.29|0.09|0.0819
71058187|NCT04856917|141621544|SUPERIORITY||LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|1.09||0.0243|TWO_SIDED|90.0|0.69|4.31||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||4.31|0.69|0.0243
71108494|NCT01214837|141722481|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.77|||||TWO_SIDED|95.0|0.62|0.97|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 23F.||0.97|0.62|
71025280|NCT02247479|141557974|SUPERIORITY||Difference in Adjusted Means|-0.36||||0.7246|TWO_SIDED|95.0|-2.35|1.64|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||1.64|-2.35|0.7246
71025281|NCT02247479|141557974|SUPERIORITY||Difference in Adjusted Means|-1.56||||0.1193|TWO_SIDED|95.0|-3.53|0.4|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||0.40|-3.53|0.1193
71025282|NCT02247479|141557975|SUPERIORITY||Difference in Adjusted Means|-0.22||||0.8659|TWO_SIDED|95.0|-2.84|2.39|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||2.39|-2.84|0.8659
71025283|NCT02247479|141557975|SUPERIORITY||Difference in Adjusted Means|-1.94||||0.1399|TWO_SIDED|95.0|-4.51|0.64|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||0.64|-4.51|0.1399
71025284|NCT02247479|141557976|SUPERIORITY||Difference in Adjusted Means|0.99||||0.4855|TWO_SIDED|95.0|-1.79|3.76|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||3.76|-1.79|0.4855
71025285|NCT02247479|141557976|SUPERIORITY||Difference in Adjusted Means|-1.6||||0.2515|TWO_SIDED|95.0|-4.33|1.13|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||1.13|-4.33|0.2515
71025286|NCT02247479|141557977|SUPERIORITY||Difference in Adjusted Means|-0.07||||0.2075|TWO_SIDED|95.0|-0.18|0.04|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline Mean FRI Index score, baseline BCVA of better seeing eye, biomarker status, and sex.||0.04|-0.18|0.2075
71025287|NCT02247479|141557977|SUPERIORITY||Difference in Adjusted Means|-0.08||||0.1222|TWO_SIDED|95.0|-0.19|0.02|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline Mean FRI Index score, baseline BCVA of better seeing eye, biomarker status, and sex.||0.02|-0.19|0.1222
71025288|NCT02247479|141557978|SUPERIORITY||Difference in Adjusted Means|-0.022||||0.8612|TWO_SIDED|95.0|-0.266|0.223|||MMRM|||CFI Positive: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.223|-0.266|0.8612
71025289|NCT02247479|141557978|SUPERIORITY||Difference in Adjusted Means|0.077||||0.5317|TWO_SIDED|95.0|-0.165|0.319|||MMRM|||CFI Positive: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.319|-0.165|0.5317
71025290|NCT02247479|141557978|SUPERIORITY||Difference in Adjusted Means|-0.033||||0.824|TWO_SIDED|95.0|-0.322|0.257|||MMRM|||CFI Negative: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.257|-0.322|0.8240
71025291|NCT02247479|141557978|SUPERIORITY||Difference in Adjusted Means|0.006||||0.9676|TWO_SIDED|95.0|-0.283|0.294|||MMRM|||CFI Negative: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.294|-0.283|0.9676
71025292|NCT01073020|141557979|SUPERIORITY||proportion|0.08||||0.6|TWO_SIDED||||||Chi-squared||Estimation parameter is the difference between the proportion of patients in the LAGB group vs. proportion of patients in the Intensive Medical Diabetes \& Weight Management (LAGB Grp) who achieved the primary outcome.|||||0.60
71058188|NCT04856917|141621544|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|1.05||0.1061|TWO_SIDED|90.0|-0.03|3.46||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||3.46|-0.03|0.1061
70934915|NCT04218864|141370330|SUPERIORITY||||||>|0.05||||||Threshold for statistical significance = 0.05|Regression, Linear|Results presented are unadjusted for any covariates.||Linear Mixed regression models (LMM) have been used to identify any difference between the intervention and the control groups over time with regards to the continuous outcomes. Group (intervention vs. control), a 5-category time (baseline, 6 week, 3 month, 6 month, 12 month) and group-by-time interaction are covariates in the model. A random subject intercept is used to account for clustering within subject.||||>0.05
71025293|NCT01073020|141557979|SUPERIORITY||proportion|0.42||||0.005|TWO_SIDED||||||Chi-squared||Estimation parameter is the difference between the proportion of patients in the RYGB group vs. proportion of patients in the Intensive Medical Diabetes \& Weight Management (RYGB Grp) who achieved the primary outcome.|||||0.005
71025294|NCT01073020|141557980|SUPERIORITY||Mean Difference (Net)|1.0||||0.33|TWO_SIDED|95.0|||||Mixed Models Analysis||Estimation parameter is the difference between the change from baseline in HbA1c in the LAGB group vs. change from baseline in HbA1c in the Intensive Medical Diabetes \& Weight Management (LAGB Grp), adjusted for baseline HbA1c.|||||0.33
71025295|NCT01073020|141557980|SUPERIORITY||Mean Difference (Net)|1.4|||<|0.001|TWO_SIDED|95.0|||||Mixed Models Analysis||Estimation parameter is the difference between the change from baseline in HbA1c in the RYGB group vs. change from baseline in HbA1c in the Intensive Medical Diabetes \& Weight Management (RYGB Grp), adjusted for baseline HbA1c.|||||<0.001
71025296|NCT01073020|141557981|SUPERIORITY||Mean Difference (Net)|2.2|||<|0.001|TWO_SIDED|95.0|||||Mixed Models Analysis||Estimation parameter is the difference between the change from baseline in BMI in the LAGB group vs. change from baseline in BMI in the Intensive Medical Diabetes \& Weight Management (LAGB Grp), adjusted for baseline BMI.|||||<0.001
71025297|NCT01073020|141557981|SUPERIORITY||Mean Difference (Net)|4.6|||<|0.001|TWO_SIDED|95.0|||||Mixed Models Analysis||Estimation parameter is the difference between the change from baseline in BMI in the RYGB group vs. change from baseline in BMI in the Intensive Medical Diabetes \& Weight Management (RYGB Grp), adjusted for baseline BMI.|||||<0.001
71025298|NCT01073020|141557982|SUPERIORITY||Mean Difference (Net)|1.5||||0.81|TWO_SIDED|95.0|||||Mixed Models Analysis||Estimation parameter is the difference between change from baseline in CHD risk over 10 yrs. in LAGB group vs. change from baseline in CHD risk over 10 yrs. in Intensive Medical Diabetes \& Weight Management (LAGB Grp), adjusted for baseline CHD risk.|||||0.81
71025299|NCT01073020|141557982|SUPERIORITY||Mean Difference (Net)|2.6||||0.009|TWO_SIDED|95.0|||||Mixed Models Analysis||Estimation parameter is the difference between change from baseline in CHD risk over 10 yrs. in RYGB group vs. change from baseline in CHD risk over 10 yrs. in Intensive Medical Diabetes \& Weight Management (RYGB Grp), adjusted for baseline CHD risk.|||||0.009
71025300|NCT03031899|141558007|NON_INFERIORITY|"1. Rose bengal should stain the areas positively stained by Toluidine blue~2. areas stained by rose bengal that shows dysplasia in biopsy"|SN, SP, PPV, NPV|||||0.005|||||||Chi-squared|||||||0.005
71025301|NCT01469364|141558022|SUPERIORITY_OR_OTHER|||||||0.203|TWO_SIDED||||||t-test, 2 sided|Paired t-test 2 sided.||||||0.2030
71025302|NCT01469364|141558023|SUPERIORITY_OR_OTHER|||||||0.2527|TWO_SIDED||||||t-test, 2 sided|Paired t-test 2 sided.||||||0.2527
71025303|NCT01469364|141558028|SUPERIORITY_OR_OTHER||Mean Absolute Difference|-1.52||||0.34|TWO_SIDED||||||t-test, 2 sided|Paired Measured t-test||P-Value for the SF-36 PCS||||0.34
71025304|NCT01469364|141558028|SUPERIORITY_OR_OTHER||Median Absolute Difference|0.78||||0.18|TWO_SIDED||||||t-test, 2 sided|Paired Measured t-test||P-Value for the SF-36 MCS||||0.18
71058189|NCT04856917|141621545|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.67||0.9333|TWO_SIDED|90.0|-2.69|2.97||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||2.97|-2.69|0.9333
71058190|NCT04856917|141621545|SUPERIORITY||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|1.67||0.3972|TWO_SIDED|90.0|-1.4|4.27||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||4.27|-1.40|0.3972
71058191|NCT04856917|141621545|SUPERIORITY||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|1.11||0.0662|TWO_SIDED|90.0|0.23|3.99||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||3.99|0.23|0.0662
71025305|NCT01469364|141558029|SUPERIORITY_OR_OTHER||Median Absolute Difference|1.62||||0.09|TWO_SIDED||||||t-test, 2 sided|Paired Measure t-test||P-Value for SF-36 PCS||||0.09
71025306|NCT01469364|141558029|SUPERIORITY_OR_OTHER||Median Absolute Difference|-1.24||||0.31|TWO_SIDED||||||t-test, 2 sided|Paired Measure t-test||P-Value for SF-36 MCS||||0.31
71025307|NCT01469364|141558030|SUPERIORITY_OR_OTHER||Median Absolute Difference|0.82||||0.56|TWO_SIDED||||||t-test, 2 sided|Paired Measure t-test||P-Value for SGRQ measure||||0.56
71025308|NCT01469364|141558031|SUPERIORITY_OR_OTHER||Median Absolute Difference|0.15||||0.68|TWO_SIDED||||||t-test, 2 sided|Paired Measure t-test||P-Value for SGRQ Measure||||0.68
71025309|NCT01469364|141558032|SUPERIORITY_OR_OTHER|||||||0.7454|TWO_SIDED||||||t-test, 2 sided|Paired t-test 2 sided.||||||0.7454
71025310|NCT01469364|141558033|SUPERIORITY_OR_OTHER|||||||0.9638|TWO_SIDED||||||t-test, 2 sided|Paired t-test was completed.||||||0.9638
71025311|NCT01590433|141558045|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71025312|NCT03532009|141558072|SUPERIORITY|||||||0.426|||||||F-test|||The p-value was obtained by pooling the p-values from Chi-square tests performed on individual data sets using the F-distribution and reflects a global test of no difference in distribution of patients in the respective categories between SZC and placebo groups. The null hypothesis was that there is no difference between SZC and placebo in the distribution of percentage of patients in the 4 RAASi treatment categories. The hypothesis was tested at a significance level of 5%.||||0.426
71025313|NCT01333033|141558132|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71058192|NCT04856917|141621545|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|1.11||0.8898|TWO_SIDED|90.0|-1.73|2.04||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||2.04|-1.73|0.8898
71025314|NCT01992107|141558154|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT (Day 22/Day 50)|1.03|||||TWO_SIDED|95.0|0.93|1.14|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain A/H1N1||1.14|0.93|
71025315|NCT01992107|141558154|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT (Day 22/Day 50)|1.05|||||TWO_SIDED|95.0|0.97|1.14|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain A/H3N2||1.14|0.97|
71025316|NCT01992107|141558154|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT (Day 22/Day 50)|0.99|||||TWO_SIDED|95.0|0.89|1.1|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain B1||1.1|0.89|
71025317|NCT01992107|141558154|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV2c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT (Day 22/Day 50)|1.0|||||TWO_SIDED|95.0|0.87|1.14|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV2c, assessed in terms of ratios of GMT against influenza strain B2||1.14|0.87|
71025318|NCT01992107|141558155|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference b/w SC rates (Day 22/Day 50)|2.0|||||TWO_SIDED|95.0|-2.5|6.9|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain A/H1N1||6.9|-2.5|
71025319|NCT01992107|141558155|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference b/w SC rates (Day 22/Day 50)|4.0|||||TWO_SIDED|95.0|-1.4|9.2|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain A/H3N2||9.2|-1.4|
71025320|NCT01992107|141558155|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference b/w SC rates (Day 22/Day 50)|0.0|||||TWO_SIDED|95.0|-5.5|4.5|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain B1||4.5|-5.5|
71025321|NCT01992107|141558155|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV2c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference b/w SC rates (Day 22/Day 50)|-2.0|||||TWO_SIDED|95.0|-6.5|3.2|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV2c in terms of differences in seroconversion rates against influenza strain B2||3.2|-6.5|
71025322|NCT01992107|141558161|SUPERIORITY_OR_OTHER||Ratios of GMT (Day 22/Day 50)|0.25|||||TWO_SIDED|95.0|0.22|0.29||||||Superiority of immune responses of QIVc to TIV1c in terms of ratios of GMT against influenza strain B2.The upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV1c/GMTQIVc) for HI antibody should not exceed the superiority margin of 1 met.||0.29|0.22|
71025323|NCT01992107|141558162|SUPERIORITY_OR_OTHER||Difference b/w SC rates(Day 22/Day 50)|-47.0|||||TWO_SIDED|95.0|-51.1|-42.1||||||Superiority of immune responses of QIVc to TIV1c in terms of seroconversion rates against influenza strain B2.The upper bound of the 2-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - %seroconversion QIVc) for HI antibody should not exceed the margin of 0 points met.||-42.1|-51.1|
71025324|NCT01992107|141558163|SUPERIORITY_OR_OTHER||Ratios of GMT (Day 22/Day 50)|0.38|||||TWO_SIDED|95.0|0.35|0.42||||||Superiority of immune responses of QIVc to TIV2c in terms of ratios of GMT against influenza strain B1.The upper bound of the 2-sided 95% CI for the ratio of GMTs (GMT TIV2c /GMTQIVc) for HI antibody should not exceed the superiority margin of 1 met.||0.42|0.35|
71025325|NCT01992107|141558164|SUPERIORITY_OR_OTHER||Difference b/w SC rates(Day 22/Day 50)|-34.0|||||TWO_SIDED|95.0|-38.8|-29.3||||||Superiority of immune responses of QIVc to TIV2c in terms of seroconversion rates against influenza strain B1.The upper bound of the 2-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c or TIV2c - %seroconversion QIVc) for HI antibody should not exceed the margin of 0 points met.||-29.3|-38.8|
71025326|NCT01288859|141558170|NON_INFERIORITY_OR_EQUIVALENCE|The results from LC-MS/MS analysis of parent polyphenols were analyzed and expressed as the absolute changes from the baseline to reduce possible effects of inter-subject fasting variability|Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.1||0.02|TWO_SIDED|95.0|||||ANOVA|||||||0.02
71025327|NCT01288859|141558171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.01||0.01|TWO_SIDED|95.0|||||ANOVA|||Statistical analysis was performed using the statistical package SPSS for Windows (version15). By the analysis of variance (ANOVA) for repeated measures the subjective time curves for all measured compounds were compared and tested for the effect of treatment and of time as factors. For all tests, following a significant main effect in the ANOVA, individual means were compared using the Bonferroni test (p \< 0.05). Results were considered significant at p \< 0.05.||||0.01
71108495|NCT01214837|141722481|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|0.89|||||TWO_SIDED|95.0|0.7|1.13|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 23F.||1.13|0.7|
71108496|NCT00269113|141722489|SUPERIORITY_OR_OTHER||Difference in percentage of participants|17.4||||0.0009|TWO_SIDED|95.0|6.4|28.4|||Fisher Exact|||||28.4|6.4|0.0009
70934916|NCT04218864|141370331|SUPERIORITY||||||>|0.05||||||Threshold for statistical significance = 0.05|Regression, Linear|Results presented are unadjusted for any covariates.||Statistical analysis strategy is identical to that for the primary outcome.||||>0.05
70851902|NCT00395343|141192092|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.6|||<|0.001||95.0|1.89|6.85||Based on a test of the odds ratio = 1, comparing the odds of having A1C \<7.0% at Week 24 in the Sitagliptin 100 mg q.d. group vs. the Placebo group.|Logistic Regression|Model terms: treatment; baseline; Metformin stratum; and insulin stratum||||6.85|1.89|<0.001
70934917|NCT04218864|141370332|SUPERIORITY||||||>|0.05||||||Threshold for statistical significance = 0.05|Regression, Linear|Results presented are unadjusted for any covariates.||Statistical analysis strategy is identical to that for the primary outcome.||||>0.05
71058193|NCT04856917|141621545|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.06||0.3664|TWO_SIDED|90.0|-0.85|2.82||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||2.82|-0.85|0.3664
71058194|NCT04856917|141621545|SUPERIORITY||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|1.1||0.0655|TWO_SIDED|90.0|0.25|4.05||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||4.05|0.25|0.0655
71058195|NCT04856917|141621545|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.2||0.6921|TWO_SIDED|90.0|-1.61|2.57||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||2.57|-1.61|0.6921
71058196|NCT04856917|141621545|SUPERIORITY||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|1.23||0.0406|TWO_SIDED|90.0|0.59|4.88||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||4.88|0.59|0.0406
71058197|NCT04856917|141621545|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.04||0.6872|TWO_SIDED|90.0|-2.24|1.38||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||1.38|-2.24|0.6872
71058198|NCT04856917|141621545|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.08||0.3392|TWO_SIDED|90.0|-0.81|2.92||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||2.92|-0.81|0.3392
71058199|NCT01169337|141621548|SUPERIORITY|||||||0.0005|||||||Log Rank|stratified 1-sided log-rank test||||||0.0005
71058200|NCT04008030|141621554|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.62||||0.0003|TWO_SIDED|95.0|0.48|0.81||Boundary for statistical significance p-value \< 0.0095.|Log Rank|Log-rank test stratified by the same factors as used in the Cox proportional hazard model.|a Cox Model stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \>= 2) as entered into the IRT.|||0.81|0.48|0.0003
71058201|NCT04008030|141621555|SUPERIORITY|Arm B over Arm C|Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.14|0.32||Boundary for statistical significance p-value \< 0.0209.|Log Rank|Log-rank test stratified by the same factors as used in the Cox proportional hazard model.|From a Cox Model stratified by tumor sidedness (left vs. right) as entered into the IRT.|||0.32|0.14|<0.0001
71058202|NCT04008030|141621557|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.52|0.79|||||from a Cox Model stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \>= 2) as entered into the IRT.|||0.79|0.52|
71058203|NCT04008030|141621558|SUPERIORITY|Arm B over Arm C|Hazard Ratio (HR)|0.32|||||TWO_SIDED|95.0|0.23|0.46|||||From a Cox Model stratified by tumor sidedness (left vs. right) as entered into the IRT.|||0.46|0.23|
71058204|NCT04008030|141621560|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.6||||||95.0|0.45|0.8|||||from a Cox proportional hazard model stratified by tumor sidedness (left vs right) and prior lines of therapy (0, 1, ≥ 2) per IRT.|||0.80|0.45|
71058205|NCT04008030|141621561|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.63||||||95.0|0.48|0.83|||||from a Cox proportional hazard model stratified by tumor sidedness (left vs right) and prior lines of therapy (0, 1, ≥ 2) per IRT.|||0.83|0.48|
71058206|NCT04008030|141621562|SUPERIORITY|Arm B over Arm C|Hazard Ratio (HR)|0.2||||||95.0|0.12|0.31|||||From a stratified Cox proportional hazard model by tumor sidedness (left vs. right) as entered into the IRT.|||0.31|0.12|
71058207|NCT04008030|141621563|SUPERIORITY|Arm B over Arm C|Hazard Ratio (HR)|0.2||||||95.0|0.12|0.31|||||From a stratified Cox proportional hazard model by tumor sidedness (left vs. right) as entered into the IRT.|||0.31|0.12|
70934918|NCT04218864|141370333|SUPERIORITY||||||>|0.05||||||Threshold for statistical significance = 0.05|Regression, Linear|Results presented are unadjusted for any covariates.||Statistical analysis strategy is identical to that for primary outcome.||||>0.05
70934919|NCT04218864|141370334|SUPERIORITY||||||>|0.05||||||Threshold for statistical significance = 0.05|Regression, Linear|Results presented are unadjusted for any covariates.||Statistical Analysis strategy is identical to that for primary outcome measure.||||>0.05
70934920|NCT00145470|141370377|SUPERIORITY|||||||0.0257||||||P-value based on the difference in the least squares (LS) means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.0257
71058208|NCT04008030|141621564|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.64||||||95.0|0.52|0.79|||||from a Cox Model stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \>= 2) as entered into the IRT.|||0.79|0.52|
71058209|NCT04008030|141621565|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.62||||||95.0|0.48|0.8|||||Cox Model stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \>= 2) as entered into the IRT.|||0.80|0.48|
71058210|NCT04008030|141621567|SUPERIORITY|Arm B over Arm A|Odds Ratio (OR)|1.77||||0.0011||95.0|1.26|2.5||Boundary for statistical significance p-value \< 0.006|Cochran-Mantel-Haenszel|Two-sided p-value from stratified CMH Test.|||Stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \>= 2) as entered into the IRT|2.50|1.26|0.0011
71058211|NCT04008030|141621568|SUPERIORITY|Arm B over Arm C|Odds Ratio (OR)|7.02||||||95.0|3.91|12.62|||||Stratified by tumor sidedness (left vs. right)|||12.62|3.91|
71058212|NCT04008030|141621568|SUPERIORITY|Arm B over Arm A|Odds Ratio (OR)|1.67||||||95.0|1.06|2.63|||||Stratified by tumor sidedness (left vs. right)|||2.63|1.06|
71058213|NCT04008030|141621569|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.45|0.83|||||From a Cox Model stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \>= 2) as entered into the IRT.|||0.83|0.45|
71058214|NCT04034927|141621582|SUPERIORITY||Odds Ratio (OR)|0.707|||||TWO_SIDED|95.0|0.241|2.068|||||The numerator is the experimental arm (odds of response) and the denominator is the control arm (odds of response).|Odds ratio for experimental arm (O + T) response compared to control arm (O) response.||2.068|0.241|
71058215|NCT03996447|141621599|SUPERIORITY||Mean Difference (Final Values)|1.82|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|1.76|1.88||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Border delineation; Reader 1. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error set at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously and for at least 2 out of 3 readers.||1.88|1.76|<.0001
70934921|NCT00145470|141370380|SUPERIORITY|||||||0.021||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 42||||0.0210
70934922|NCT00145470|141370381|SUPERIORITY|||||||0.0073||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.0073
70934923|NCT00145470|141370382|SUPERIORITY|||||||0.3928|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 3||||0.3928
70934924|NCT00145470|141370382|SUPERIORITY|||||||0.7923|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 7||||0.7923
70934925|NCT00145470|141370382|SUPERIORITY|||||||0.0701|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 14||||0.0701
70934926|NCT00145470|141370382|SUPERIORITY|||||||0.1634|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 21||||0.1634
70934927|NCT00145470|141370382|SUPERIORITY|||||||0.037|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 42||||0.0370
70934928|NCT00145470|141370382|SUPERIORITY|||||||0.0488|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 63||||0.0488
71058216|NCT03996447|141621599|SUPERIORITY||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|1.81|2.0||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Border delineation; Reader 2. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||2.00|1.81|<.0001
71058217|NCT03996447|141621599|SUPERIORITY||Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|1.29|1.44||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Border delineation; Reader 3. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||1.44|1.29|<.0001
71058218|NCT03996447|141621599|SUPERIORITY||Mean Difference (Final Values)|2.26|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|2.2|2.33||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Internal morphology; Reader 1. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||2.33|2.20|<.0001
70934929|NCT00145470|141370382|SUPERIORITY|||||||0.0152|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 84||||0.0152
70934930|NCT00145470|141370383|SUPERIORITY|||||||0.3709|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 3||||0.3709
70934931|NCT00145470|141370383|SUPERIORITY|||||||0.8837|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 7||||0.8837
70934932|NCT00145470|141370383|SUPERIORITY|||||||0.1153|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 14||||0.1153
70934933|NCT00145470|141370383|SUPERIORITY|||||||0.0158|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 21||||0.0158
71058219|NCT03996447|141621599|SUPERIORITY||Mean Difference (Final Values)|1.77|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|1.69|1.85||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Internal morphology; Reader 2. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||1.85|1.69|<.0001
71058220|NCT03996447|141621599|SUPERIORITY||Mean Difference (Final Values)|1.96|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|1.85|2.06||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Internal morphology; Reader 3. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||2.06|1.85|<.0001
71058221|NCT03996447|141621599|SUPERIORITY||Mean Difference (Final Values)|2.77|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|2.69|2.85||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Contrast enhancement; Reader 1. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||2.85|2.69|<.0001
71058222|NCT03996447|141621599|SUPERIORITY||Mean Difference (Final Values)|2.58|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|2.49|2.67||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Contrast enhancement - Reader 2. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||2.67|2.49|<.0001
71058223|NCT03996447|141621599|SUPERIORITY||Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|2.84|2.95||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Contrast enhancement; Reader 3. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||2.95|2.84|<.0001
71058224|NCT03996447|141621600|NON_INFERIORITY|Non-inferiority between gadopiclenol and gadobutrol was concluded if the lower bound of this confidence interval was above the non-inferiority margin set to 0.35 for at least 2 out of 3 blinded readers and for the 3 co-primary criteria simultaneously.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|-0.06|0.02||The Null hypothesis was rejected if the 2-sided 95% Confidence Interval (CI) for the difference \[gadopiclenol scores mean - gadobutrol scores mean\] had its lower limit above -0.35.|t-test, 2 sided|The Student's t-based 95% CIs of the difference between gadopiclenol and gadobutrol were constructed for each of 3 co-primary criteria.||Criterion: Border delineation; Reader 1. The null hypothesis was that the difference in mean scores between gadopiclenol and gadobutrol for each of the 3 primary criteria was equal to the non inferiority margin (-0.35). The alternative hypothesis was that the difference in mean scores between gadopiclenol and gadobutrol for each of the 3 co-primary criteria was greater than the non inferiority margin.||0.02|-0.06|<0.0001
70934934|NCT00145470|141370383|SUPERIORITY|||||||0.0143|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 42||||0.0143
70934935|NCT00145470|141370383|SUPERIORITY|||||||0.0196|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 63||||0.0196
70934936|NCT00145470|141370383|SUPERIORITY|||||||0.0148|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 84||||0.0148
71077943|NCT02913105|141664399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.02||||0.7519|TWO_SIDED|90.0|0.92|1.14|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 84||1.14|0.92|0.7519
71108497|NCT00269113|141722490|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71108498|NCT00269113|141722491|SUPERIORITY_OR_OTHER|||||||0.0127|||||||Log Rank|||||||0.0127
71108499|NCT00269113|141722492|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71108500|NCT00269113|141722493|SUPERIORITY_OR_OTHER|||||||0.0186|||||||Log Rank|||||||0.0186
71108501|NCT00269113|141722494|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Log Rank|||||||0.0002
71108502|NCT00269113|141722495|SUPERIORITY_OR_OTHER|||||||0.0017|||||||Log Rank|||||||0.0017
71108503|NCT01714323|141722528|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07|||>|0.05|TWO_SIDED|95.0|0.84|1.37|||Chi-squared|||Data from all three sites were combined after determining that outcomes did not vary by hospital using Breslow-Day tests. The proportion abstinent by treatment arm was assessed using chi-square test.||1.37|0.84|>0.05
71108504|NCT01714323|141722529|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
71108505|NCT01714323|141722530|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||This compares at Month 1||||<0.001
71108506|NCT01714323|141722530|SUPERIORITY||||||<|0.01|||||||Chi-squared|||This is analysis for Month 3||||<0.01
70851903|NCT00395343|141192093|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.584||95.0|0.45|4.18||Based on a test of the odds ratio = 1, comparing the odds of having A1C \<7.0% at Week 24 in the Sitagliptin 100 mg q.d. group vs. the Placebo group.|Logistic Regression|Model terms: treatment; baseline; Metformin stratum; and insulin stratum|This parameter estimate and 95% confidence interval correspond to the odds of having A1C \<6.5% at Week 24 in the Sitagliptin 100 mg q.d. group vs. the Placebo group.|||4.18|0.45|0.584
70851904|NCT00395343|141192094|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56|||<|0.001||95.0|-0.72|-0.4|||ANCOVA|Model terms: treatment; baseline; metformin stratum; insulin stratum, treatment by insulin stratum interaction||||-0.40|-0.72|<0.001
70851905|NCT02223377|141192118|SUPERIORITY||Odds Ratio (OR)|1.0||||0.997|TWO_SIDED|95.0|0.56|1.78|||Regression, Logistic|||||1.78|0.56|0.997
70851906|NCT02223377|141192123|SUPERIORITY||Mean Difference (Final Values)|-0.73||||0.04|TWO_SIDED|95.0|-1.43|-0.03|||ANOVA|||||-0.03|-1.43|0.040
70851907|NCT02937584|141192179|OTHER||Geometric mean ratio to baseline|1.11||||0.0187|TWO_SIDED|95.0|1.02|1.22||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment|t-test, 2 sided|Within-group comparison to baseline using paired test||||1.22|1.02|0.0187
70934937|NCT00145470|141370384|SUPERIORITY|||||||0.0046||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.0046
70934938|NCT00145470|141370385|SUPERIORITY|||||||0.0006||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.0006
71108507|NCT01714323|141722530|SUPERIORITY||||||<|0.09|||||||Chi-squared|||This is for Month 6||||<0.09
71108508|NCT01714323|141722532|SUPERIORITY_OR_OTHER||||||<|0.001||||||This is the p value for the comparison at each follow up point: 1 mo, 3 mo, and 6 mo.|Chi-squared|||||||<0.001
71108509|NCT01714323|141722533|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
71108510|NCT01714323|141722534|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
71108511|NCT00755807|141722535|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed model repeated measures (MMRM):Change from Baseline=Baseline+Treatment+Investigator+Week+Treatment\*Week+Baseline\*Week,participant random effect.||Null hypothesis: no difference between duloxetine and placebo on pain severity reduction as measured by weekly mean of the daily 24-hour average pain scores in participants assessed at 6 weeks. Sample size is determined using 2-sided t-test with significance level of 0.05, and 5% of randomized participants without post-baseline data due to very early discontinuation. With 119 participants per arm, study has approximately 80% power to detect an effect size of 0.375 on treatment group difference.||||0.001
71108512|NCT00755807|141722536|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||P-value is for the 30% Reduction (LOCF). P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.027
71108513|NCT00755807|141722536|SUPERIORITY_OR_OTHER|||||||0.246||95.0||||P-value is for 50% Reduction (LOCF). P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.246
71108514|NCT00755807|141722536|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||P-value is for the 30% Reduction (BOCF). P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.024
71108515|NCT00755807|141722536|SUPERIORITY_OR_OTHER|||||||0.165||95.0||||P-value is for 50% Reduction (BOCF). P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.165
71108516|NCT00755807|141722537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.121|TWO_SIDED|95.0|-0.06|0.49||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Analysis of Variance (ANOVA) Model: PGI improvement at Endpoint = Treatment + Investigator.|The mean difference is for placebo - duloxetine.|||0.49|-0.06|0.121
71108517|NCT00755807|141722538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.016|TWO_SIDED|95.0|0.12|1.2||P-value is for BPI Severity for Worst Pain score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.20|0.12|0.016
71108518|NCT00755807|141722538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48||||0.043|TWO_SIDED|95.0|0.02|0.95||P-value is for BPI Severity for Least Pain score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.95|0.02|0.043
71108519|NCT00755807|141722538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.03|TWO_SIDED|95.0|0.05|0.99||P-value is for BPI Severity for Average Pain score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.99|0.05|0.030
71108520|NCT00755807|141722538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.001|TWO_SIDED|95.0|0.36|1.43||P-value is for BPI Severity for Pain Right Now score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.43|0.36|0.001
71025328|NCT01288859|141558172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.01||0.04|TWO_SIDED|95.0|||||ANOVA|||||||0.04
71025329|NCT03588390|141558174|OTHER||Slope|0.696|STANDARD_ERROR_OF_MEAN|0.0971|||TWO_SIDED|95.0|0.5006|0.8914|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of slope.|The basic model for the investigation of dose proportionality was a power model that described the functional relationship between the dose and PK endpoints.||0.8914|0.5006|
71058225|NCT03996447|141621600|NON_INFERIORITY|Non-inferiority between gadopiclenol and gadobutrol was concluded if the lower bound of this confidence interval was above the non-inferiority margin set to 0.35 for at least 2 out of 3 blinded readers and for the 3 co-primary criteria simultaneously.|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.04|0.11||The Null hypothesis was rejected if the 2-sided 95% Confidence Interval (CI) for the difference \[gadopiclenol scores mean - gadobutrol scores mean\] had its lower limit above -0.35.|t-test, 2 sided|The Student's t-based 95% CIs of the difference between gadopiclenol and gadobutrol were constructed for each of 3 co-primary criteria.||Criterion: Border delineation; Reader 2. The null hypothesis was that the difference in mean scores between gadopiclenol and gadobutrol for each of the 3 primary criteria was equal to the non inferiority margin (-0.35). The alternative hypothesis was that the difference in mean scores between gadopiclenol and gadobutrol for each of the 3 co-primary criteria was greater than the non inferiority margin.||0.11|-0.04|<0.0001
71058226|NCT03996447|141621600|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|-0.01|0.05|||t-test, 2 sided|||Criterion: Border delineation; Reader 3||0.05|-0.01|<0.0001
71058227|NCT03996447|141621600|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|-0.04|0.03|||t-test, 2 sided|||Criterion: Internal morphology; Reader 1||0.03|-0.04|<0.0001
71058228|NCT03996447|141621600|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|-0.05|0.09|||t-test, 2 sided|||Criterion: Internal morphology; Reader 2||0.09|-0.05|<0.0001
71058229|NCT03996447|141621600|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.01|0.08|||t-test, 2 sided|||Criterion: Internal morphology; Reader 3||0.08|0.01|<0.0001
71058230|NCT03996447|141621600|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.0001|TWO_SIDED|95.0|-0.04|0.07|||t-test, 2 sided|||Criterion: Contrast enhancement; Reader 1||0.07|-0.04|0.0001
71058231|NCT03996447|141621600|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.03|0.12|||t-test, 2 sided|||Criterion: Contrast enhancement; Reader 2||0.12|-0.03|<0.0001
71058232|NCT03996447|141621600|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.03|0.15|||t-test, 2 sided|||Criterion: Contrast enhancement; Reader 3||0.15|0.03|<0.0001
70934939|NCT00145470|141370386|SUPERIORITY|||||||0.3497||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.3497
70934940|NCT00145470|141370387|SUPERIORITY|||||||0.7753||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.7753
71025330|NCT03588390|141558174|OTHER||Slope|0.9244|STANDARD_ERROR_OF_MEAN|0.122|||TWO_SIDED|95.0|0.6764|1.1724|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of slope.|The basic model for the investigation of dose proportionality was a power model that described the functional relationship between the dose and PK endpoints.||1.1724|0.6764|
71058233|NCT03355469|141621603|SUPERIORITY||Mean Difference (Final Values)|3.53||||0.045|TWO_SIDED|95.0|0.08|6.99||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.017.|ANCOVA|Linear ANCOVA model adjusted for pre-intervention FMD.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention 0 min unscaled FMD change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||6.99|0.08|0.045
71058234|NCT03355469|141621603|SUPERIORITY||Mean Difference (Final Values)|1.15||||0.507|TWO_SIDED|95.0|-2.42|4.73||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.050.|ANCOVA|ANCOVA linear model adjusted for pre-intervention FMD.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention 0 min unscaled FMD change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||4.73|-2.42|0.507
71058235|NCT03355469|141621603|SUPERIORITY||Mean Difference (Final Values)|4.98||||0.014|TWO_SIDED|95.0|1.14|8.83||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.008.|ANCOVA|ANCOVA linear model adjusted for pre-intervention FMD.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention 0 min unscaled FMD change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||8.83|1.14|0.014
71058236|NCT03355469|141621603|SUPERIORITY||Mean Difference (Final Values)|2.38||||0.237|TWO_SIDED|95.0|-1.66|6.42||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.033.|ANCOVA|ANCOVA linear model adjusted for pre-intervention FMD.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention 0 min unscaled FMD change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||6.42|-1.66|0.237
71108521|NCT00755807|141722538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.083|TWO_SIDED|95.0|-0.07|1.11||P-value is for BPI Interference for General Activity score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.11|-0.07|0.083
71108522|NCT00755807|141722538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.034|TWO_SIDED|95.0|0.05|1.27||P-value is for BPI Interference for Mood score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.27|0.05|0.034
71108523|NCT00755807|141722538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55||||0.089|TWO_SIDED|95.0|-0.08|1.19||P-value is for BPI Interference for Walking Ability score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.19|-0.08|0.089
71108524|NCT00755807|141722538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.291|TWO_SIDED|95.0|-0.28|0.93||P-value is for BPI Interference for Normal Work score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.93|-0.28|0.291
71108525|NCT00755807|141722538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.077|TWO_SIDED|95.0|-0.06|1.05||P-value is for BPI Interference for Relations With Others score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.05|-0.06|0.077
71108526|NCT00755807|141722538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.148|TWO_SIDED|95.0|-0.15|0.97||P-value is for BPI Interference for Sleep score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.97|-0.15|0.148
71108527|NCT00755807|141722538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.582|TWO_SIDED|95.0|-0.45|0.79||P-value is for BPI Interference for Enjoyment Of Life score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.79|-0.45|0.582
70851908|NCT02937584|141192179|OTHER||Geometric mean ratio to baseline|1.23|||<|0.0001|TWO_SIDED|95.0|1.14|1.33||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment|t-test, 2 sided|Within-group comparison to baseline using paired test||||1.33|1.14|<0.0001
70851909|NCT02937584|141192180|OTHER||Geometric mean ratio to baseline|0.75||||0.0219|TWO_SIDED|95.0|0.59|0.95||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment|t-test, 2 sided|Within-group comparison to baseline using paired test||||0.95|0.59|0.0219
70851910|NCT02937584|141192180|OTHER||Geometric mean ratio to baseline|0.56|||<|0.0001|TWO_SIDED|95.0|0.44|0.71||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment|t-test, 2 sided|Within-group comparison to baseline using paired test||||0.71|0.44|<0.0001
71108528|NCT00755807|141722538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.067|TWO_SIDED|95.0|-0.03|0.94||P-value is for BPI Mean Interference score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.94|-0.03|0.067
71108529|NCT00755807|141722539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.041|TWO_SIDED|95.0|0.01|0.45||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.45|0.01|0.041
71108530|NCT00755807|141722540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.5|TWO_SIDED|95.0|-3.9|1.91||P-value is for treatment comparison of change from baseline on MSQOL Physical Health Composite Section score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.91|-3.90|0.500
71108531|NCT00755807|141722540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22||||0.512|TWO_SIDED|95.0|-4.87|2.44||P-value is for treatment comparison of change from baseline on MSQOL Mental Health Composite Section score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||2.44|-4.87|0.512
71108532|NCT00755807|141722540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.72|TWO_SIDED|95.0|-4.51|3.12||P-value is for treatment comparison of change from baseline on MSQOL Physical Health Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||3.12|-4.51|0.720
71108533|NCT00755807|141722540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.973|TWO_SIDED|95.0|-3.58|3.46||P-value is for treatment comparison of change from baseline on MSQOL Health Perceptions Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||3.46|-3.58|0.973
71025331|NCT03588390|141558175|OTHER||Slope|0.6533|STANDARD_ERROR_OF_MEAN|0.0982|||TWO_SIDED|95.0|0.4556|0.851|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of slope.|The basic model for the investigation of dose proportionality was a power model that described the functional relationship between the dose and PK endpoints.||0.8510|0.4556|
71025332|NCT03588390|141558175|OTHER||Slope|0.8586|STANDARD_ERROR_OF_MEAN|0.1307|||TWO_SIDED|95.0|0.5929|1.1242|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of slope.|The basic model for the investigation of dose proportionality was a power model that described the functional relationship between the dose and PK endpoints.||1.1242|0.5929|
71108534|NCT00755807|141722540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.991|TWO_SIDED|95.0|-4.07|4.02||P-value is for treatment comparison of change from baseline on MSQOL Energy Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||4.02|-4.07|0.991
71108535|NCT00755807|141722540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.14||||0.441|TWO_SIDED|95.0|-11.14|4.87||P-value is for treatment comparison of change from baseline on MSQOL Role Limitation Due to Physical Problems Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||4.87|-11.14|0.441
70851911|NCT02937584|141192181|OTHER||Geometric mean ratio to baseline|1.12||||0.0283|TWO_SIDED|95.0|1.01|1.24|||t-test, 2 sided|Within-group comparison to baseline using paired test||||1.24|1.01|0.0283
70851912|NCT02937584|141192181|OTHER||Geometric mean ratio to baseline|1.21|||<|0.0001|TWO_SIDED|95.0|1.12|1.31|||t-test, 2 sided|Within-group comparison to baseline using paired test||||1.31|1.12|<0.0001
70851913|NCT02937584|141192182|OTHER||Geometric mean ratio to baseline|0.76||||0.0304|TWO_SIDED|95.0|0.59|0.97|||t-test, 2 sided|Within-group comparison to baseline using paired test||||0.97|0.59|0.0304
70851914|NCT02937584|141192182|OTHER||Geometric mean ratio to baseline|0.55||||0.0003|TWO_SIDED|95.0|0.41|0.72|||t-test, 2 sided|Within-group comparison to baseline using paired test||||0.72|0.41|0.0003
70934941|NCT00145470|141370388|SUPERIORITY|||||||0.0073||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.0073
71025333|NCT02444533|141558184|SUPERIORITY|||||||0.043|||||||t-test, 2 sided|||Comparison between groups for pain on day of surgery. Statistical significance was defined as a p-value less than 0.05.||||0.043
71025334|NCT02444533|141558184|SUPERIORITY|||||||0.445|||||||t-test, 2 sided|||Comparison between groups for pain at 14 days after surgery. Statistical significance was defined as a p-value less than 0.05.||||0.445
71025335|NCT02444533|141558185|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|||Comparison between groups for ibuprofen usage. Statistical significance was defined as a p-value less than 0.05.||||0.650
71025336|NCT02444533|141558185|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||Comparison between groups for acetaminophen usage. Statistical significance was defined as a p-value less than 0.05.||||0.970
71058237|NCT03355469|141621603|SUPERIORITY||Mean Difference (Final Values)|1.45||||0.486|TWO_SIDED|95.0|-2.8|5.7||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.042.|ANCOVA|ANCOVA linear model adjusted for pre-intervention FMD.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention 0 min unscaled FMD change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||5.70|-2.80|0.486
71058238|NCT03355469|141621603|SUPERIORITY||Mean Difference (Final Values)|3.83||||0.081|TWO_SIDED|95.0|-0.53|8.19||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.025.|ANCOVA|ANCOVA linear model adjusted for pre-intervention FMD.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention 0 min unscaled FMD change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||8.19|-0.53|0.081
71058239|NCT03355469|141621604|SUPERIORITY||Mean Difference (Final Values)|0.0073||||0.373|TWO_SIDED|95.0|-0.0093|0.024||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.025.|ANCOVA|ANCOVA linear model adjusted for pre-intervention GIR.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention GIR, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.0240|-0.0093|0.373
71058240|NCT03355469|141621604|SUPERIORITY||Mean Difference (Final Values)|0.0097||||0.198|TWO_SIDED|95.0|-0.0055|0.025||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.008.|ANCOVA|ANCOVA linear model adjusted for pre-intervention GIR.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention GIR, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.0250|-0.0055|0.198
71025337|NCT02444533|141558185|SUPERIORITY|||||||0.835|||||||t-test, 2 sided|||Comparison between groups for oxycodone usage. Statistical significance was defined as a p-value less than 0.05.||||0.835
71108536|NCT00755807|141722540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.58||||0.108|TWO_SIDED|95.0|-7.94|0.79||P-value is for treatment comparison of change from baseline on MSQOL Pain Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.79|-7.94|0.108
71108537|NCT00755807|141722540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.948|TWO_SIDED|95.0|-5.77|5.39||P-value is for treatment comparison of change from baseline on MSQOL Sexual Function Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||5.39|-5.77|0.948
71058241|NCT03355469|141621604|SUPERIORITY||Mean Difference (Final Values)|0.0041||||0.622|TWO_SIDED|95.0|-0.0129|0.0211||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.033.|ANCOVA|ANCOVA linear model adjusted for pre-intervention GIR.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention GIR, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.0211|-0.0129|0.622
71058242|NCT03355469|141621604|SUPERIORITY||Mean Difference (Final Values)|-0.0024||||0.666|TWO_SIDED|95.0|-0.0136|0.0088||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.050.|ANCOVA|ANCOVA linear model adjusted for pre-intervention GIR.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention GIR, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.0088|-0.0136|0.666
71058243|NCT03355469|141621604|SUPERIORITY||Mean Difference (Final Values)|-0.0032||||0.634|TWO_SIDED|95.0|-0.0169|0.0104||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.042.|ANCOVA|ANCOVA linear model adjusted for pre-intervention GIR.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention GIR, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.0104|-0.0169|0.634
71058244|NCT03355469|141621604|SUPERIORITY||Mean Difference (Final Values)|-0.0056||||0.336|TWO_SIDED|95.0|-0.0174|0.0062||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.017.|ANCOVA|ANCOVA linear model adjusted for pre-intervention GIR.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention GIR, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.0062|-0.0174|0.336
71058245|NCT03355469|141621605|SUPERIORITY||Mean Difference (Final Values)|1.51||||0.671|TWO_SIDED|95.0|-5.68|8.69||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.042.|ANCOVA|ANCOVA linear model adjusted for pre-intervention AIx75.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention AIx75 change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||8.69|-5.68|0.671
71058246|NCT03355469|141621605|SUPERIORITY||Mean Difference (Final Values)|-4.82||||0.17|TWO_SIDED|95.0|-11.84|2.19||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.025.|ANCOVA|ANCOVA linear model adjusted for pre-intervention AIx75.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention AIx75 change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||2.19|-11.84|0.170
71108538|NCT00755807|141722540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.96||||0.374|TWO_SIDED|95.0|-2.37|6.28||P-value is for treatment comparison of change from baseline on MSQOL Social Function Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||6.28|-2.37|0.374
71108539|NCT00755807|141722540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38||||0.867|TWO_SIDED|95.0|-4.1|4.87||P-value is for treatment comparison of change from baseline on MSQOL Health Distress Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||4.87|-4.10|0.867
71058247|NCT03355469|141621605|SUPERIORITY||Mean Difference (Final Values)|-0.66||||0.839|TWO_SIDED|95.0|-7.29|5.97||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.050.|ANCOVA|ANCOVA linear model adjusted for pre-intervention AIx75.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention AIx75 change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||5.97|-7.29|0.839
71058248|NCT03355469|141621605|SUPERIORITY||Mean Difference (Final Values)|6.33||||0.024|TWO_SIDED|95.0|0.86|11.8||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.008.|ANCOVA|ANCOVA linear model adjusted for pre-intervention AIx75.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention AIx75 change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||11.80|0.86|0.024
71108540|NCT00755807|141722540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.77||||0.306|TWO_SIDED|95.0|-1.63|5.17||P-value is for treatment comparison of change from baseline on MSQOL Overall Quality Of Life Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||5.17|-1.63|0.306
71108541|NCT00755807|141722540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.733|TWO_SIDED|95.0|-4.08|2.88||P-value is for treatment comparison of change from baseline on MSQOL Emotional Well-being Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||2.88|-4.08|0.733
70934942|NCT00145470|141370389|SUPERIORITY|||||||0.0102||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.0102
70934943|NCT00145470|141370390|SUPERIORITY|||||||0.3684||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.3684
70934944|NCT00145470|141370391|SUPERIORITY|||||||0.937||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.9370
70934945|NCT00145470|141370392|SUPERIORITY|||||||0.2492||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.2492
70851915|NCT02937584|141192183|OTHER||Mean Change from Baseline|0.065||||0.1582|TWO_SIDED|95.0|-0.028|0.158|||t-test, 2 sided|Within-group comparison to baseline using paired test||||0.158|-0.028|0.1582
70934946|NCT00145470|141370393|SUPERIORITY|||||||0.4683||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.4683
70934947|NCT00145470|141370394|SUPERIORITY|||||||0.5683||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.5683
70934948|NCT00145470|141370395|SUPERIORITY|||||||0.9693||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.9693
70934949|NCT00145470|141370396|SUPERIORITY|||||||0.6136||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.6136
70934950|NCT00145470|141370397|SUPERIORITY|||||||0.1586||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.1586
70934951|NCT00145470|141370398|SUPERIORITY|||||||0.055||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Verbal Memory - CFB at Day 21||||0.0550
70934952|NCT00145470|141370398|SUPERIORITY|||||||0.7469||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Visual Memory - CFB at Day 21||||0.7469
70934953|NCT00145470|141370398|SUPERIORITY|||||||0.3253||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Processing Speed - CFB at Day 21||||0.3253
71025338|NCT02444533|141558186|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison between groups at 7 days. Statistical significance was defined as a p-value less than 0.05.||||1.0
71025339|NCT01006707|141558245|SUPERIORITY_OR_OTHER|||||||0.042|||||||ANOVA|||Results were considered significant at p\<0.05.||||0.042
71025340|NCT01006707|141558246|SUPERIORITY_OR_OTHER|||||||0.322|||||||ANOVA|||Results were considered significant at p\<0.05.||||0.322
71025341|NCT01006707|141558247|SUPERIORITY_OR_OTHER|||||||0.261|||||||ANOVA|||Results were considered significant at p\<0.05.||||0.261
71025342|NCT05085613|141558259|SUPERIORITY||Mean Difference (Final Values)|0.6279928|STANDARD_ERROR_OF_MEAN|4.150369||0.998|TWO_SIDED|95.0|-9.463627|10.71961||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF=6|Economic recovery condition - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||10.71961|-9.463627|0.998
71058249|NCT03355469|141621605|SUPERIORITY||Mean Difference (Final Values)|-2.16||||0.385|TWO_SIDED|95.0|-7.16|2.83||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.033.|ANCOVA|ANCOVA linear model adjusted for pre-intervention AIx75.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention AIx75 change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||2.83|-7.16|0.385
70934954|NCT00145470|141370398|SUPERIORITY|||||||0.3885||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Social Acuity - CFB at Day 21||||0.3885
71025343|NCT05085613|141558259|SUPERIORITY||Mean Difference (Final Values)|4.044194|STANDARD_ERROR_OF_MEAN|4.302202||0.725|TWO_SIDED|95.0|-6.416608|14.505||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Freedom - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||14.505|-6.416608|0.725
71025344|NCT05085613|141558259|SUPERIORITY||Mean Difference (Final Values)|-1.53656|STANDARD_ERROR_OF_MEAN|-1.53656||0.98|TWO_SIDED|95.0|-12.25295|9.179834||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Humor - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||9.179834|-12.25295|0.980
71025345|NCT05085613|141558260|SUPERIORITY||Mean Difference (Final Values)|7.002255|STANDARD_ERROR_OF_MEAN|8.801527||0.813|TWO_SIDED|95.0|-14.39448|28.39899||Sidak's adjusted p-value for multiple comparisons|ANCOVA|Df = 6|Economic recovery condition - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||28.39899|-14.39448|0.813
71025346|NCT05085613|141558260|SUPERIORITY||Mean Difference (Final Values)|15.12214|STANDARD_ERROR_OF_MEAN|9.07444||0.268|TWO_SIDED|95.0|-6.938055|37.18234||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Freedom - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||37.18234|-6.938055|0.268
70934955|NCT00145470|141370398|SUPERIORITY|||||||0.5975||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Reasoning - CFB at Day 21||||0.5975
71058250|NCT03355469|141621605|SUPERIORITY||Mean Difference (Final Values)|4.17||||0.08|TWO_SIDED|95.0|-0.53|8.86||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.017.|ANCOVA|ANCOVA linear model adjusted for pre-intervention AIx75.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention AIx75 change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||8.86|-0.53|0.080
71058251|NCT03355469|141621606|SUPERIORITY||Mean Difference (Final Values)|-0.032||||0.088|TWO_SIDED|95.0|-0.069|0.005||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.017.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBF.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBF change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.005|-0.069|0.088
71058252|NCT03355469|141621606|SUPERIORITY||Mean Difference (Final Values)|0.001||||0.96|TWO_SIDED|95.0|-0.059|0.062||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.050.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBF.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBF change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.062|-0.059|0.960
71058253|NCT03355469|141621606|SUPERIORITY||Mean Difference (Final Values)|-0.052||||0.075|TWO_SIDED|95.0|-0.109|0.006||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.008.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBF.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBF change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.006|-0.109|0.075
71058254|NCT03355469|141621606|SUPERIORITY||Mean Difference (Final Values)|-0.033||||0.258|TWO_SIDED|95.0|-0.094|0.028||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.033.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBF.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBF change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.028|-0.094|0.258
71058255|NCT03355469|141621606|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.443|TWO_SIDED|95.0|-0.075|0.035||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.042.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBF.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBF change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.035|-0.075|0.443
71058256|NCT03355469|141621606|SUPERIORITY||Mean Difference (Final Values)|-0.053||||0.144|TWO_SIDED|95.0|-0.126|0.02||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.025.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBF.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBF change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.020|-0.126|0.144
71058257|NCT03355469|141621607|SUPERIORITY||Mean Difference (Final Values)|-0.007||||0.147|TWO_SIDED|95.0|-0.017|0.003||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.017.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MFV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MFV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.003|-0.017|0.147
71058258|NCT03355469|141621607|SUPERIORITY||Mean Difference (Final Values)|0.001||||0.943|TWO_SIDED|95.0|-0.016|0.017||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.050.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MFV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MFV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.017|-0.016|0.943
71058259|NCT03355469|141621607|SUPERIORITY||Mean Difference (Final Values)|-0.012||||0.108|TWO_SIDED|95.0|-0.027|0.003||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.008.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MFV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MFV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.003|-0.027|0.108
71108542|NCT00755807|141722540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9||||0.283|TWO_SIDED|95.0|-13.88|4.08||P-value is for treatment comparison of change from baseline on MSQOL Role Limitation Due to Emotional Problems score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||4.08|-13.88|0.283
70934956|NCT00145470|141370398|SUPERIORITY|||||||0.069||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Executive Functioning - CFB at Day 21||||0.0690
70851916|NCT02937584|141192183|OTHER||Mean Change from Baseline|0.151||||0.0375|TWO_SIDED|95.0|0.01|0.292|||t-test, 2 sided|Within-group comparison to baseline using paired test||||0.292|0.010|0.0375
70934957|NCT00145470|141370398|SUPERIORITY|||||||0.797||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Working Memory - CFB at Day 21||||0.7970
70934958|NCT00145470|141370398|SUPERIORITY|||||||0.8339||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Sustained Attention - CFB at Day 21||||0.8339
70934959|NCT00145470|141370398|SUPERIORITY|||||||0.2101||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Composite Memory - CFB at Day 21||||0.2101
70934960|NCT00145470|141370399|SUPERIORITY|||||||0.6914||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Verbal Memory - CFB at Day 84||||0.6914
70934961|NCT00145470|141370399|SUPERIORITY|||||||0.8805||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Visual Memory - CFB at Day 84||||0.8805
71058260|NCT03355469|141621607|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.319|TWO_SIDED|95.0|-0.024|0.009||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.033.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MFV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MFV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.009|-0.024|0.319
70934962|NCT00145470|141370399|SUPERIORITY|||||||0.4878||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Processing Speed - CFB at Day 84||||0.4878
70934963|NCT00145470|141370399|SUPERIORITY|||||||0.8051||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Social Acuity - CFB at Day 84||||0.8051
71058261|NCT03355469|141621607|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.496|TWO_SIDED|95.0|-0.019|0.01||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.042.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MFV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MFV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.010|-0.019|0.496
71058262|NCT03355469|141621607|SUPERIORITY||Mean Difference (Final Values)|-0.012||||0.187|TWO_SIDED|95.0|-0.031|0.007||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.025.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MFV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MFV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.007|-0.031|0.187
70934964|NCT00145470|141370399|SUPERIORITY|||||||0.1925||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Reasoning - CFB at Day 84||||0.1925
71058263|NCT03355469|141621608|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.086|TWO_SIDED|95.0|-0.495|0.035||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.008.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.035|-0.495|0.086
71058264|NCT03355469|141621608|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.608|TWO_SIDED|95.0|-0.354|0.574||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.050.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.574|-0.354|0.608
71058265|NCT03355469|141621608|SUPERIORITY||Mean Difference (Final Values)|-0.344||||0.11|TWO_SIDED|95.0|-0.779|0.09||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.017.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.090|-0.779|0.110
71108543|NCT00755807|141722540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81||||0.664|TWO_SIDED|95.0|-4.49|2.86||P-value is for treatment comparison of change from baseline on MSQOL Cognitive Function Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||2.86|-4.49|0.664
70934965|NCT00145470|141370399|SUPERIORITY|||||||0.0514||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Executive Functioning - CFB at Day 84||||0.0514
70934966|NCT00145470|141370399|SUPERIORITY|||||||0.9898||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Working Memory - CFB at Day 84||||0.9898
70934967|NCT00145470|141370399|SUPERIORITY|||||||0.5683||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Sustained Attention - CFB at Day 84||||0.5683
70934968|NCT00145470|141370399|SUPERIORITY|||||||0.8907||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Composite Memory - CFB at Day 84||||0.8907
70934969|NCT00145470|141370400|SUPERIORITY|||||||0.0613|||||||Log Rank|||||||0.0613
70934970|NCT00145470|141370401|SUPERIORITY|||||||0.7493||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.7493
71058266|NCT03355469|141621608|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.145|TWO_SIDED|95.0|-0.818|0.137||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.033.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.137|-0.818|0.145
71058267|NCT03355469|141621608|SUPERIORITY||Mean Difference (Final Values)|-0.114||||0.565|TWO_SIDED|95.0|-0.538|0.309||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.042.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.309|-0.538|0.565
71108544|NCT00755807|141722540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98||||0.504|TWO_SIDED|95.0|-7.81|3.85||P-value is for treatment comparison of change from baseline on MSQOL Change in Health Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine|||3.85|-7.81|0.504
71108545|NCT00755807|141722540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.02||||0.27|TWO_SIDED|95.0|-11.18|3.14||P-value is for treatment comparison of change from baseline on MSQOL Satisfaction with Sexual Function Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine|||3.14|-11.18|0.270
70851917|NCT02937584|141192184|OTHER||Geometric mean ratio to baseline|0.978||||0.6176|TWO_SIDED|95.0|0.891|1.073|||t-test, 2 sided|Within-group comparison to baseline using paired test||||1.073|0.891|0.6176
70934971|NCT00145470|141370402|SUPERIORITY|||||||0.4884||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.4884
70934972|NCT00145470|141370403|SUPERIORITY|||||||0.128||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||PCS - Change from Baseline at Day 21||||0.1280
70934973|NCT00145470|141370403|SUPERIORITY|||||||0.0215||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||MCS - Change from Baseline at Day 21||||0.0215
70934974|NCT00145470|141370404|SUPERIORITY|||||||0.1331||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||PCS - Change from Baseline at Day 84||||0.1331
70934975|NCT00145470|141370404|SUPERIORITY|||||||0.2024||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||MCS - Change from Baseline at Day 84||||0.2024
70934976|NCT04323800|141370418|SUPERIORITY||Risk Difference (RD)|0.01||||0.42|ONE_SIDED|95.0||||One-sided p-value|Restricted Mean Survival Test statistic|||||||0.42
70934977|NCT04323800|141370419|SUPERIORITY||Risk Difference (RD)|-5.0||||0.67|TWO_SIDED|95.0|-31.0|19.0|||Chi-squared|||||19|-31|0.67
70934978|NCT04323800|141370420|SUPERIORITY||Risk Difference (RD)|-47.0||||0.06|TWO_SIDED|95.0|-100.0|2.0|||Chi-squared|||||2|-100|0.06
70934979|NCT02660086|141370506|SUPERIORITY||Mean Difference (Net)|0.2||||0.7|TWO_SIDED|95.0|-0.6|1.0|||Mixed Models Analysis|||||1.0|-0.6|0.70
70934980|NCT02660086|141370507|SUPERIORITY||Mean Difference (Net)|0.6||||0.2|TWO_SIDED|95.0|-0.3|1.4|||Mixed Models Analysis|||||1.4|-0.3|0.20
70934981|NCT02660086|141370508|SUPERIORITY||Mean Difference (Net)|-1.3||||0.24|TWO_SIDED|95.0|-3.6|0.9|||Mixed Models Analysis|||Change in systolic BP at 12 months||0.9|-3.6|0.24
70934982|NCT02660086|141370508|SUPERIORITY||Mean Difference (Net)|1.5||||0.19|TWO_SIDED|95.0|-0.7|3.7|||Mixed Models Analysis|||Change in systolic BP at 24 months||3.7|-0.7|0.19
70934983|NCT02660086|141370508|SUPERIORITY||Mean Difference (Net)|-1.6||||0.07|TWO_SIDED|95.0|-3.2|0.1|||Mixed Models Analysis|||Change in diastolic BP at 12 months||0.1|-3.2|0.07
71108546|NCT00755807|141722541|SUPERIORITY_OR_OTHER|||||||0.119||95.0||||P-value is for treatment comparison in number of participants with CSSR-S Suicidal Ideation during first 6 weeks of acute treatment. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.119
71108547|NCT00755807|141722541|SUPERIORITY_OR_OTHER|||||||0.494||95.0||||P-value is for treatment comparison in number of participants with CSSR-S Suicidal Behavior during first 6 weeks of acute treatment. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.494
71108548|NCT00755807|141722541|SUPERIORITY_OR_OTHER|||||||0.494||95.0||||P-value is for treatment comparison in number of participants with CSSR-S Suicidal Acts during first 6 weeks of acute treatment. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.494
71108549|NCT00755807|141722542|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed model repeated measures model:Change from Baseline=Baseline+Treatment+Investigator+Week+Treatment\*Week+Baseline\*Week; participant=random effect.||||||0.002
71108550|NCT00755807|141722543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.662|TWO_SIDED|95.0|-0.06|0.04||P-value is for treatment comparison of change from baseline on BDI-II Question #9 score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.04|-0.06|0.662
71108551|NCT00755807|141722544|SUPERIORITY_OR_OTHER|||||||0.244||95.0||||This is the P-value for Discontinuation Due to Any Reason.|Fisher Exact|||||||0.244
71108552|NCT00755807|141722544|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||This is the P-value for Adverse Event (AE).|Fisher Exact|||||||0.012
71108553|NCT00755807|141722544|SUPERIORITY_OR_OTHER|||||||0.622||95.0||||This is the P-value for Protocol Violation.|Fisher Exact|||||||0.622
71108554|NCT00755807|141722544|SUPERIORITY_OR_OTHER|||||||1||95.0||||This is the P-value for Subject Decision.|Fisher Exact|||||||1.00
71108555|NCT00755807|141722544|SUPERIORITY_OR_OTHER|||||||1||95.0||||This is the P-value for Lack of Efficacy.|Fisher Exact|||||||1.00
71108556|NCT00755807|141722544|SUPERIORITY_OR_OTHER|||||||1||95.0||||This is the P-value for Physician Decision.|Fisher Exact|||||||1.00
71108557|NCT00755807|141722547|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-value is for treatment comparison of change from baseline on Bicarbonate, HCO3. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Model: Rank-transformed change from Baseline = Treatment + Investigator.||||||0.047
71108558|NCT00755807|141722548|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||P-value is for treatment comparison of change from baseline on creatinine. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Model: Rank-transformed change from Baseline = Treatment + Investigator.||||||0.033
71108559|NCT00755807|141722549|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||P-value is for treatment comparison of change from baseline on platelet count. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Model: Rank-transformed change from baseline = Treatment + Investigator.||||||0.034
71108560|NCT00755807|141722550|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value is for treatment comparison of change from baseline on inorganic phosphorus. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Model: Rank-transformed change from Baseline = Treatment + Investigator.||||||0.007
71108561|NCT00755807|141722551|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||P-value is for treatment comparison of change from baseline on uric acid. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Model: Rank-transformed change from Baseline = Treatment + Investigator.||||||0.025
70851918|NCT02937584|141192184|OTHER||Geometric mean ratio to baseline|0.938||||0.2699|TWO_SIDED|95.0|0.833|1.056|||t-test, 2 sided|Within-group comparison to baseline using paired test||||1.056|0.833|0.2699
71108562|NCT00755807|141722552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86||||0.322|TWO_SIDED|95.0|-2.55|0.84||P-value is for treatment comparison of change from baseline on diastolic blood pressure. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.84|-2.55|0.322
71108563|NCT00755807|141722552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.787|TWO_SIDED|95.0|-3.32|2.52||P-value is for treatment comparison of change from baseline on systolic blood pressure. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||2.52|-3.32|0.787
71108564|NCT00755807|141722553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55||||0.16|TWO_SIDED|95.0|-3.7|0.61||P-value is for treatment comparison of change from baseline on pulse rate. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.61|-3.70|0.160
71108565|NCT00755807|141722554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77||||0.003|TWO_SIDED|95.0|0.27|1.26||P-value is for treatment comparison of change from baseline on weight. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.26|0.27|0.003
71058268|NCT03355469|141621608|SUPERIORITY||Mean Difference (Final Values)|-0.454||||0.11|TWO_SIDED|95.0|-1.025|0.116||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.025.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.116|-1.025|0.110
71058269|NCT01708941|141621609|SUPERIORITY|||||||0.49|||||||Log Rank|||The primary comparison was ipilimumab + HDI versus ipilimumab alone, across ipilimumab dose (Arms A \& C versus Arms B \& D)||||0.490
71058270|NCT01708941|141621610|SUPERIORITY|||||||0.144|||||||Log Rank|||PFS comparison of higher dose ipilimumab versus lower dose ipilimumab (Arms A \& B versus Arms C \& D)||||0.144
71058271|NCT01708941|141621611|SUPERIORITY|||||||0.691|||||||Log Rank|||||||0.691
71058272|NCT01708941|141621612|SUPERIORITY|||||||0.868|||||||Log Rank|||Comparison of higher dose ipilimumab versus lower dose ipilimumab across HDI status (Arms A \& B versus Arms C \& D)||||0.868
71058273|NCT01575548|141621615|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.21|TWO_SIDED|95.0|0.54|1.29|||Log Rank|Stratified log rank test was used to compare DFS between the two arms.||||1.29|0.54|0.21
71058274|NCT03952585|141621630|NON_INFERIORITY|Estimated 9-month PFS = 96.5% and lower acceptable threshold = 91.8%, resulting in a non-inferiority margin of 4.7%. H0: HR = 2.4; alternative hypothesis (HA): HR=1.0. One-sided type I error rate of 10% (20% after Bonferroni adjustment for each experimental arm comparison), 80% power, 24 months of accrual with 1 year of additional follow-up, and 1% increasing yearly rate of drop-out up to 3%, a log rank test requires 22 events from 266 patients per comparison resulting in 133 patients per arm.|Hazard Ratio (HR)|7.42|||||ONE_SIDED|90.0||19.46|||||Reference level = Arm 1|The null hypothesis (H0) for each comparison in phase II will be rejected if the 90% upper confidence of the hazard ratio (HR) (experimental arm / standard arm) is less than HR=2.4.||19.46||
71058275|NCT03952585|141621630|NON_INFERIORITY|Estimated 9-month PFS = 96.5% and lower acceptable threshold = 91.8%, resulting in a non-inferiority margin of 4.7%. H0: HR = 2.4; alternative hypothesis (HA): HR=1.0. One-sided type I error rate of 10% (20% after Bonferroni adjustment for each experimental arm comparison), 80% power, 24 months of accrual with 1 year of additional follow-up, and 1% increasing yearly rate of drop-out up to 3%, a log rank test requires 22 events from 266 patients per comparison resulting in 133 patients per arm.|Hazard Ratio (HR)|5.55|||||ONE_SIDED|90.0||14.85|||||Reference level = Arm 1|The null hypothesis (H0) for each comparison in phase II will be rejected if the 90% upper confidence of the hazard ratio (HR) (experimental arm / standard arm) is less than HR=2.4.||14.85||
71058276|NCT03952585|141621633|SUPERIORITY||Hazard Ratio (HR)|20.56|||||TWO_SIDED|95.0|1.05|403.31|||||Cause-specific; reference level = Arm 1|||403.31|1.05|
71058277|NCT03952585|141621633|SUPERIORITY||Hazard Ratio (HR)|12.87|||||TWO_SIDED|95.0|0.58|287.93|||||Reference level = Arm 1|||287.93|0.58|
71058278|NCT03952585|141621634|SUPERIORITY||Cox Proportional Hazard|1.78|||||TWO_SIDED|95.0|0.34|9.46|||||Cause-specific; reference level = Arm 1|||9.46|0.34|
71058279|NCT03952585|141621634|SUPERIORITY||Cox Proportional Hazard|1.43|||||TWO_SIDED|95.0|0.24|8.45|||||Cause-specific; reference level = Arm 1|||8.45|0.24|
71058280|NCT03952585|141621635|SUPERIORITY||Hazard Ratio (HR)|5.58|||||TWO_SIDED|95.0|0.67|46.41|||||Reference level = Arm 1|||46.41|0.67|
71058281|NCT03952585|141621635|SUPERIORITY||Hazard Ratio (HR)|4.87|||||TWO_SIDED|95.0|0.57|41.74|||||Reference level = Arm 1|||41.74|0.57|
71058282|NCT02048813|141621647|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.001|TWO_SIDED|95.0|0.22|0.56|||Log Rank|||||0.56|0.22|<.001
71058283|NCT02048813|141621648|SUPERIORITY||Hazard Ratio (HR)|0.17|||<|0.001|TWO_SIDED|95.0|0.05|0.54|||Log Rank|||||0.54|0.05|<.001
71108566|NCT00755807|141722555|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean PGI-I score at 18 weeks for all participants who entered extension phase.||||||<0.001
71058284|NCT01708954|141621659|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.37|||||TWO_SIDED|80.0|0.25|0.53|||||Hazard ratio of Arm C/Arm A|||0.53|0.25|
71058285|NCT01708954|141621659|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.39|||||TWO_SIDED|80.0|0.27|0.55|||||Hazard ratio of Arm B/Arm A|||0.55|0.27|
71058286|NCT03631199|141621694|EQUIVALENCE|Nominal p-values are presented without any statistical inference since there was no adjustment for multiplicity.|Hazard Ratio (HR)|0.62||||0.00164|TWO_SIDED|95.0|0.45|0.86|||Log Rank|||Chest pain||0.86|0.45|0.00164
71058287|NCT03631199|141621694|EQUIVALENCE|Nominal p-values are presented without any statistical inference since there was no adjustment for multiplicity.|Hazard Ratio (HR)|0.59||||0.00069|TWO_SIDED|95.0|0.43|0.82|||Log Rank|||Cough||0.82|0.43|0.00069
71058288|NCT03631199|141621694|EQUIVALENCE|Nominal p-values are presented without any statistical inference since there was no adjustment for multiplicity.|Hazard Ratio (HR)|0.66||||0.00045|TWO_SIDED|95.0|0.51|0.84|||Log Rank|||Dyspnea||0.84|0.51|0.00045
71058289|NCT03631199|141621695|EQUIVALENCE|Nominal p-values are presented without any statistical inference since there was no adjustment for multiplicity.|Hazard Ratio (HR)|0.86||||0.113|TWO_SIDED|95.0|0.66|1.1|||Log Rank|||Quality of Life||1.10|0.66|0.113
71058290|NCT03631199|141621695|EQUIVALENCE|Nominal p-values are presented without any statistical inference since there was no adjustment for multiplicity.|Hazard Ratio (HR)|0.68||||0.00433|TWO_SIDED|95.0|0.51|0.91|||Log Rank|||Shortness of Breath||0.91|0.51|0.00433
71058291|NCT03631199|141621695|EQUIVALENCE|Nominal p-values are presented without any statistical inference since there was no adjustment for multiplicity.|Hazard Ratio (HR)|0.93||||0.294|TWO_SIDED|95.0|0.72|1.2|||Log Rank|||Pain||1.20|0.72|0.294
71058292|NCT02567435|141621699|SUPERIORITY||3-Year EFS|65.8||||0.44|TWO_SIDED||||||Log Rank|||||||0.44
71058293|NCT02567435|141621700|SUPERIORITY||3-Year OS|78.2||||0.56|TWO_SIDED||||||Log Rank|||||||0.56
71058294|NCT03651700|141621732|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<.05
71058295|NCT03651700|141621733|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<.05
71058296|NCT04856930|141621734|SUPERIORITY||Least Square (LS) Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.25||0.7841|TWO_SIDED|90.0|-2.42|1.73||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates; baseline AN count as continuous covariate.|Linear repeated measures model (LRMM)|||||1.73|-2.42|0.7841
71108567|NCT00755807|141722556|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for BPI-S for Worst Pain. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-S for Worst Pain.||||||<0.001
71108568|NCT00755807|141722556|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for BPI-S for Least Pain. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-S for Least Pain score.||||||<0.001
71108569|NCT00755807|141722556|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for BPI-S for Average Pain. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-S for Average Pain score.||||||<0.001
71108570|NCT00755807|141722556|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-S for Pain Right Now score.||||||<0.001
71108571|NCT00755807|141722556|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for BPI-I for General Activity. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for General Activity score.||||||<0.001
71108572|NCT00755807|141722556|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI-I for Mood. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Mood score.||||||<0.001
71108573|NCT00755807|141722556|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI-I for Walking Ability. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Walking Ability score.||||||<0.001
71108574|NCT00755807|141722556|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI-I for Normal Work. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Normal Work score.||||||<0.001
71108575|NCT00755807|141722556|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI-I for Relations With Others. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from baseline to endpoint on BPI-I for Relations With Others score.||||||<0.001
70934984|NCT02660086|141370508|SUPERIORITY||Mean Difference (Net)|0.1||||0.94|TWO_SIDED|95.0|-1.5|1.6|||Mixed Models Analysis|||Change in diastolic BP at 24 months||1.6|-1.5|0.94
70934985|NCT02660086|141370509|SUPERIORITY||Mean Difference (Net)|-1.3||||0.54|TWO_SIDED|95.0|-5.6|2.9|||Mixed Models Analysis|||Change in total cholesterol at 12 months||2.9|-5.6|0.54
70934986|NCT02660086|141370509|SUPERIORITY||Mean Difference (Net)|1.6||||0.53|TWO_SIDED|95.0|-3.5|6.7|||Mixed Models Analysis|||Change in total cholesterol at 24 months||6.7|-3.5|0.53
71108576|NCT00755807|141722556|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI-I for Sleep. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Sleep score.||||||<0.001
71108577|NCT00755807|141722556|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI-I for Enjoyment of Life. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Enjoyment Of Life score.||||||<0.001
71108578|NCT00755807|141722556|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI for Mean Interference Score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI for Mean Interference score.||||||<0.001
71108579|NCT00755807|141722557|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on CGI-S score for all participants who entered extension phase.||||||<0.001
71108580|NCT00755807|141722558|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Physical Health Composite Section score.||||||0.002
71108581|NCT00755807|141722558|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Mental Health Composite Section score.||||||0.054
71108582|NCT00755807|141722558|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Physical Health Subsection score.||||||0.002
70934987|NCT02660086|141370510|SUPERIORITY||Mean Difference (Net)|-1.2||||0.51|TWO_SIDED|95.0|-4.8|2.4|||Mixed Models Analysis|||Change in LDL at 12 months||2.4|-4.8|0.51
70934988|NCT02660086|141370510|SUPERIORITY||Mean Difference (Net)|1.2||||0.6|TWO_SIDED|95.0|-3.4|5.7|||Mixed Models Analysis|||Change in LDL at 24 months||5.7|-3.4|0.60
70934989|NCT02660086|141370511|SUPERIORITY||Mean Difference (Net)|-2.9||||0.48|TWO_SIDED|95.0|-10.8|5.1|||Mixed Models Analysis|||Change in triglycerides at 12 months||5.1|-10.8|0.48
70934990|NCT02660086|141370511|SUPERIORITY||Mean Difference (Net)|4.0||||0.29|TWO_SIDED|95.0|-3.4|11.5|||Mixed Models Analysis|||Change in triglycerides at 24 months||11.5|-3.4|0.29
71108583|NCT00755807|141722558|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Health Perceptions Subsection score.||||||0.025
71108584|NCT00755807|141722558|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Energy Subsection score.||||||0.008
71108585|NCT00755807|141722558|SUPERIORITY_OR_OTHER|||||||0.858||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Role Limitation Due to Physical Problems Subsection score.||||||0.858
71108586|NCT00755807|141722558|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Pain Subsection score.||||||<0.001
70851919|NCT00635219|141192185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|1.13||0.1321|TWO_SIDED|95.0|-3.92|0.51||Since p-value \>0.025, hierarchically testing stopped here.|ANCOVA||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||0.51|-3.92|0.1321
70934991|NCT02660086|141370512|SUPERIORITY||Mean Difference (Net)|-0.2||||0.8|TWO_SIDED|95.0|-1.9|1.5|||Mixed Models Analysis|||Change in HDL at 12 months||1.5|-1.9|0.80
71025347|NCT05085613|141558260|SUPERIORITY||Mean Difference (Final Values)|14.4032|STANDARD_ERROR_OF_MEAN|9.305576||0.33|TWO_SIDED|95.0|-8.218891|37.0253||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Humor - Control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||37.0253|-8.218891|0.330
71025348|NCT05085613|141558261|SUPERIORITY||Mean Difference (Final Values)|-1.457003|STANDARD_ERROR_OF_MEAN|6.380984||0.994|TWO_SIDED|95.0|-16.98852|14.07451||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 5|Economic recovery - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||14.07451|-16.98852|0.994
71025349|NCT05085613|141558261|SUPERIORITY||Mean Difference (Final Values)|-1.097586|STANDARD_ERROR_OF_MEAN|6.675066||0.998|TWO_SIDED|95.0|-17.34491|15.14973||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 5|Freedom - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||15.14973|-17.34491|0.998
71025350|NCT05085613|141558261|SUPERIORITY||Mean Difference (Final Values)|8.926191|STANDARD_ERROR_OF_MEAN|6.588643||0.447|TWO_SIDED|95.0|-7.110771|24.96315||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 5|Humor - Control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||24.96315|-7.110771|0.447
71025351|NCT05085613|141558262|SUPERIORITY||Mean Difference (Final Values)|-4.154612|STANDARD_ERROR_OF_MEAN|1.986723||0.113|TWO_SIDED|95.0|-8.985328|0.6761041||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Economic recovery - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||.6761041|-8.985328|0.113
71025352|NCT05085613|141558262|SUPERIORITY||Mean Difference (Final Values)|-2.685896|STANDARD_ERROR_OF_MEAN|2.046067||0.473|TWO_SIDED|95.0|-7.6609|2.289114||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Freedom - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||2.289114|-7.66090|0.473
71108587|NCT00755807|141722558|SUPERIORITY_OR_OTHER|||||||0.637||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Sexual Function Subsection score.||||||0.637
70934992|NCT02660086|141370512|SUPERIORITY||Mean Difference (Net)|-0.3||||0.72|TWO_SIDED|95.0|-1.9|1.3|||Mixed Models Analysis|||Change in HDL at 24 months||1.3|-1.9|0.72
71025353|NCT05085613|141558262|SUPERIORITY||Mean Difference (Final Values)|-6.469932|STANDARD_ERROR_OF_MEAN|2.102231||0.008|TWO_SIDED|95.0|-11.58151|-1.358358||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Humor - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||-1.358358|-11.58151|0.008
71025354|NCT00952484|141558263|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||P-value based on Wilcoxon rank sum test comparing the median RGI-C score for the asfotase alfa combined reporting group to the historical control group.|Wilcoxon (Mann-Whitney)|||||||0.0007
71025355|NCT00952484|141558264|SUPERIORITY_OR_OTHER|||||||0.0097|TWO_SIDED|||||P-value testing whether the mean change from Baseline differs from Zero based on a t-test.|t-test, 2 sided|||||||0.0097
71025356|NCT00952484|141558265|SUPERIORITY_OR_OTHER|||||||0.0789|TWO_SIDED|||||P-value testing whether the mean change from Baseline differs from Zero based on a t-test.|t-test, 2 sided|||||||0.0789
71025357|NCT00952484|141558266|SUPERIORITY_OR_OTHER|||||||0.7417|TWO_SIDED|||||P-value testing whether the mean change from Baseline differs from Zero based on a t-test.|t-test, 2 sided|||||||0.7417
71025358|NCT00952484|141558267|SUPERIORITY_OR_OTHER|||||||0.757|TWO_SIDED|||||P-value testing whether the mean change from Baseline differs from Zero based on a Wilcoxon Signed-Rank test.|Wilcoxon Signed-Rank|||||||0.7570
71108588|NCT00755807|141722558|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Social Function Subsection score.||||||0.051
71108589|NCT00755807|141722558|SUPERIORITY_OR_OTHER|||||||0.27||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Health Distress Subsection score.||||||0.270
71108590|NCT00755807|141722558|SUPERIORITY_OR_OTHER|||||||0.061||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Overall Quality Of Life Subsection score.||||||0.061
71025359|NCT00952484|141558268|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value testing whether the mean change from Baseline differs from Zero based on a t-test.|t-test, 2 sided|||||||<0.0001
71025360|NCT00952484|141558269|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||P-value testing whether the mean change from Baseline differs from Zero based on a t-test.|t-test, 2 sided|||||||0.0007
71025361|NCT02422290|141558276|SUPERIORITY||Mean Difference (Final Values)|1.53|STANDARD_ERROR_OF_MEAN|1.83||0.2|TWO_SIDED|95.0|-2.27|7.87|||t-test, 2 sided|||Paired sample t-test was calculated to test mean difference between CY-BOCS scores at the time points Baseline and Day 14.||7.87|-2.27|.20
71025362|NCT02422290|141558277|SUPERIORITY||Mean Difference (Final Values)|1.63|STANDARD_ERROR_OF_MEAN|0.49||0.18|TWO_SIDED|95.0|-0.56|2.16|||t-test, 2 sided|||Paired sample t-test was calculated to test mean difference between CGI-S scores at the time points Baseline and Day 14.||2.16|-.56|.18
71025363|NCT02422290|141558278|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|1.0||1|TWO_SIDED|95.0|-2.78|2.78|||t-test, 2 sided|||Paired sample t-test was calculated to test mean difference between OCD-VAS scores at the time points Baseline and Day 14.||2.78|-2.78|1.00
71025364|NCT02422290|141558279|SUPERIORITY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|5.41||0.77|TWO_SIDED|95.0|-15.46|18.96|||t-test, 2 sided|||Paired sample t-test was calculated to test mean difference between OCD-VAS scores at the time points Baseline and Day 14.||18.96|-15.46|.77
71025365|NCT01842958|141558290|NON_INFERIORITY|The test arm will be considered non-inferior to the control arm if the 95% upper confidence interval of the estimated difference between the test and control arms is less than -0.5mm.||||||0.02|||||||ANCOVA|||The primary efficacy endpoint is change in crestal bone level from loading to 12 months post-loading. The primary analysis is a test for non-inferiority of the test implant to the control implant at the one-sided 5% significance level. The null hypothesis is that µ3.3 ≥ µ4.1 + δ, where µ3.3 is the mean change in crestal bone level for the test implants, µ4.1 is the mean change in crestal bone level for control implants, and δ is a pre-specified clinically significant difference.||||0.02
71025366|NCT05034731|141558310|NON_INFERIORITY|Non-inferiority analyses were based on paired t-tests looking at the differences in speech scores calculated using the investigational speech scores minus the control speech scores. The primary efficacy analyses tested the null hypothesis (inferiority) that the mean of the paired differences in AzBio sentence scores in quite (remote fitting - in-office fitting) are less than or equal to -10 percentile points.|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
71025367|NCT05034731|141558311|NON_INFERIORITY|Non-inferiority analyses were based on paired t-tests looking at the differences in speech scores calculated using the investigational speech scores minus the control speech scores. The primary efficacy analyses tested the null hypothesis (inferiority) that the mean of the paired differences in AzBio sentence scores in quite (remote fitting - in-office fitting) are less than or equal to -10 percentile points.|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
71025368|NCT01325207|141558313|OTHER||||||||||||||||||The Maximum Tolerated Dose (MTD) was determined to be 80mg IT every two weeks. This is based on no DLTs being seeing in Cohorts 1-4 with lower doses and 1 DLT out of 7 patients observed at 80mg IT in Cohort 5.|||
71025369|NCT00602030|141558321|SUPERIORITY||Adjusted Odds Ratio|0.72||||0.505|TWO_SIDED|95.0|0.27|1.89|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel estimation of odds ratio adjusted for the smoking history stratification factor, using placebo as reference group.|||1.89|0.27|0.505
71025370|NCT00602030|141558322|SUPERIORITY||Adjusted Odds Ratio|0.31||||0.13|TWO_SIDED|95.0|0.06|1.54|||Cochran-Mantel-Haenszel||Estimation of odds ratio was adjusted for the smoking history stratification factor, using placebo as reference group .|||1.54|0.06|0.13
71025371|NCT00602030|141558323|SUPERIORITY||Adjusted Odds Ratio|1.06||||0.918|TWO_SIDED|95.0|0.34|3.27|||Cochran-Mantel-Haenszel||Estimation of odds ratio was adjusted for the smoking history stratification factor, using placebo as reference group.|||3.27|0.34|0.918
71025372|NCT00283686|141558336|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.52|TWO_SIDED|95.0|-0.8|5.0||adjusted for age, sex, race, baseline estimated GFR, and clinical site.|Mixed Models Analysis|Test for differences between treatment groups over time.||||5.0|-0.8|0.52
71108591|NCT00755807|141722558|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Emotional Well-being Subsection score.||||||0.007
70934993|NCT02660086|141370513|SUPERIORITY||Mean Difference (Net)|0.0||||0.62|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||Change in hemoglobin A1C at 12 months||0.1|-0.1|0.62
71025373|NCT00283686|141558336|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.006|TWO_SIDED|95.0|-1.6|-0.2||adjusted for age, sex, race, baseline estimated GFR, and clinical site.|Mixed Models Analysis|Testing differences between blood pressure groups over time||||-0.2|-1.6|0.006
70934994|NCT02660086|141370513|SUPERIORITY||Mean Difference (Net)|0.0||||0.4|TWO_SIDED|95.0|0.0|0.1|||Mixed Models Analysis|||Change in hemoglobin A1C at 24 months||0.1|0.0|0.40
71025374|NCT00283686|141558337|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1||||0.52|TWO_SIDED|95.0|-0.6|0.3||adjusting for age, sex, race, and clinical site|Mixed Models Analysis|Testing for differences in treatment over time (differences in slopes over time).||||0.3|-0.6|0.52
71025375|NCT00283686|141558337|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.55|TWO_SIDED|95.0|-0.3|0.6||adjusted for age, sex, race, and clinical site|Mixed Models Analysis|Testing for differences between groups over time (differences in slopes over time)||||0.6|-0.3|0.55
71025376|NCT00283686|141558338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.57|TWO_SIDED|95.0|-3.3|1.9|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||1.9|-3.3|0.57
71025377|NCT00283686|141558338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|||<|0.0001|TWO_SIDED|95.0|-8.5|-3.4|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||-3.4|-8.5|<0.0001
71025378|NCT00283686|141558339|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3||||0.18|TWO_SIDED|95.0|-3.1|0.6|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||0.6|-3.1|0.18
71108592|NCT00755807|141722558|SUPERIORITY_OR_OTHER|||||||0.253||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Role Limitation Due to Emotional Problems score.||||||0.253
71025379|NCT00283686|141558339|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.19|TWO_SIDED|95.0|-3.1|0.6|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||0.6|-3.1|0.19
71025380|NCT00283686|141558340|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.088||||0.58|TWO_SIDED|95.0|-0.4|0.22|||Mixed Models Analysis|adjusted for age, sex, race, baseline estimated GFR, and clinical site|comparing the annual change over time between ACE/ARB and ACE alone|||0.22|-0.40|0.58
70934995|NCT02660086|141370514|SUPERIORITY||Mean Difference (Net)|7.3|||<|0.001|TWO_SIDED|95.0|5.4|9.3|||Mixed Models Analysis|||Change in green labeled purchases during 12 month intervention (months 1-12) compared to baseline 12 months||9.3|5.4|<0.001
71025381|NCT00283686|141558340|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.6||||0.0002|TWO_SIDED|95.0|-0.91|-0.29|||Mixed Models Analysis|adjusted for age, sex, race, baseline estimated GFR, and clinical site|comparing annual change in LVMI between Low Blood Pressure and Standard Blood Pressure groups|||-0.29|-0.91|0.0002
71025382|NCT00283686|141558341|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.97||||0.29|TWO_SIDED|95.0|-2.55|8.5|||Mixed Models Analysis|adjusted for age, sex, race, baseline estimated GFR, and clinical site|difference in annual change in mL/min/1.73 m\^2 for ACE+ARB compared to ACE alone|||8.50|-2.55|0.29
71025383|NCT00283686|141558341|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.98||||0.73|TWO_SIDED|95.0|-4.54|6.5|||Mixed Models Analysis|adjusting for age, sex, race, baseline estimated GFR, and clinical site|difference in annual change mL/min/1.73 m\^2 between low and standard blood pressure groups|||6.50|-4.54|0.73
71025384|NCT00283686|141558342|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.0228|TWO_SIDED|95.0|0.53|0.95|||Regression, Cox|adjusting for age, sex, race, and clinical site||||0.95|0.53|0.0228
71025385|NCT00283686|141558342|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.59|TWO_SIDED|95.0|0.7|1.22|||Regression, Cox|adjusting for age, sex, race, and clinical site||||1.22|0.70|0.59
71025386|NCT00283686|141558343|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.016||||0.87|TWO_SIDED|95.0|-0.19|0.17|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||0.17|-0.19|0.87
71025387|NCT00283686|141558343|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13||||0.14|TWO_SIDED|95.0|-0.046|0.31|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||0.31|-0.046|0.14
71025388|NCT00283686|141558344|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25||||0.0221|TWO_SIDED|95.0|0.036|0.46|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||0.46|0.036|0.0221
71025389|NCT00283686|141558344|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23||||0.0339|TWO_SIDED|95.0|-0.44|-0.018|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||-0.018|-0.44|0.0339
71025390|NCT00319956|141558388|SUPERIORITY|||||||0.2|||||||Chi-squared|||||||0.20
71025391|NCT02607800|141558396|NON_INFERIORITY|Noninferiority was demonstrated if the lower bound of the 2-sided 95% confidence interval (CI) for the difference in SVR12 was greater than -5%. If the lower bound of the CI was greater than -5% (ie, the noninferiority null hypothesis was rejected), a 2-sided stratified Cochran-Mantel-Haenszel test was to be used to test for the superiority of SOF/VEL/VOX for 8 weeks over SOF/VEL for 12 weeks at a significance level of 0.05.|Difference in proportions|-3.2|||||TWO_SIDED|95.0|-6.0|-0.4|||||Difference in proportions between treatment groups and associated 95% CI were calculated based on stratum-adjusted Mantel-Haenszel proportions.|||-0.4|-6.0|
71025392|NCT01533428|141558434|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.6||||0.025|TWO_SIDED|95.0|-12.3|-0.8|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||All statistical comparisons were made using two-sided tests at the 5% significance level||-0.8|-12.3|0.025
71025393|NCT01533428|141558435|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.1||||0.018|TWO_SIDED|95.0|-12.9|-1.2|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||All statistical comparisons were made using two-sided tests at the 5% significance level.||-1.2|-12.9|0.018
71025394|NCT01533428|141558436|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.1||||0.208|TWO_SIDED|95.0|-10.4|2.3|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 2.||2.3|-10.4|0.208
71058297|NCT04856930|141621734|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|1.25||0.2885|TWO_SIDED|90.0|-0.74|3.4||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates; baseline AN count as continuous covariate.|LRMM|||||3.40|-0.74|0.2885
71058298|NCT04856930|141621735|SUPERIORITY||LS Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|8.97||0.5939|TWO_SIDED|90.0|-19.66|10.07||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates; baseline AN count as continuous covariate.|LRMM|||||10.07|-19.66|0.5939
71058299|NCT04856930|141621735|SUPERIORITY||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|8.95||0.7002|TWO_SIDED|90.0|-11.38|18.29||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates; baseline AN count as continuous covariate.|LRMM|||||18.29|-11.38|0.7002
71058300|NCT04856930|141621736|SUPERIORITY||Risk Difference (RD)|5.3|||||TWO_SIDED|90.0|-13.3|23.4|||||Estimate parameter and 90% CI was based on Unadjusted Risk Difference and exact unconditional confidence intervals (CI).|||23.4|-13.3|
70934996|NCT02660086|141370514|SUPERIORITY||Mean Difference (Net)|4.8|||<|0.001|TWO_SIDED|95.0|2.9|6.8|||Mixed Models Analysis|||Change in green-labeled purhases during 12 month follow-up (months 13-24) compared to 12 month baseline||6.8|2.9|<0.001
71025395|NCT01533428|141558436|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.7||||0.036|TWO_SIDED|95.0|-13.1|-0.4|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 3.||-0.4|-13.1|0.036
71058301|NCT04856930|141621736|SUPERIORITY||Risk Difference (RD)|3.3|||||TWO_SIDED|90.0|-14.6|21.0|||||Estimate parameter and 90% C was based on Unadjusted Risk Difference and exact unconditional CIs.|||21.0|-14.6|
70934997|NCT02660086|141370515|SUPERIORITY||Mean Difference (Net)|-3.9|||<|0.001|TWO_SIDED|95.0|-5.0|-2.7|||Mixed Models Analysis|||Change in red labeled purchases during 12 month intervention (months 1-12) compared to baseline 12 months||-2.7|-5.0|<0.001
70934998|NCT02660086|141370515|SUPERIORITY||Mean Difference (Net)|-3.1|||<|0.001|TWO_SIDED|95.0|-4.3|-2.0|||Mixed Models Analysis|||Change in red labeled purchases during 12-month follow up (months 13-24) compared to baseline 12 months||-2.0|-4.3|<0.001
71058302|NCT04856930|141621737|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.54||0.7282|TWO_SIDED|90.0|-1.08|0.7||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline worst HS Pain NRS as a continuous covariate.|LRMM|||||0.70|-1.08|0.7282
71058303|NCT04856930|141621737|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.54||0.5019|TWO_SIDED|90.0|-1.25|0.53||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline worst HS Pain NRS as a continuous covariate.|LRMM|||||0.53|-1.25|0.5019
71058304|NCT04856930|141621738|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.49||0.7698|TWO_SIDED|90.0|-0.96|0.67||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline average HS Pain NRS as a continuous covariate.|LRMM|||||0.67|-0.96|0.7698
71058305|NCT04856930|141621738|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.49||0.7468|TWO_SIDED|90.0|-0.97|0.65||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline average HS Pain NRS as a continuous covariate.|LRMM|||||0.65|-0.97|0.7468
71058306|NCT04856930|141621739|SUPERIORITY||LS Mean Difference|-25.7|STANDARD_ERROR_OF_MEAN|23.46||0.275|TWO_SIDED|90.0|-64.57|13.14||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline worst HS Pain NRS as a continuous covariate.|LRMM|||||13.14|-64.57|0.2750
71058307|NCT04856930|141621739|SUPERIORITY||LS Mean Difference|-21.2|STANDARD_ERROR_OF_MEAN|23.81||0.3757|TWO_SIDED|90.0|-60.6|18.28||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline worst HS Pain NRS as a continuous covariate.|LRMM|||||18.28|-60.60|0.3757
71058308|NCT04856930|141621740|SUPERIORITY||LS Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|13.04||0.6146|TWO_SIDED|90.0|-28.22|15.05||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline average HS Pain NRS as a continuous covariate.|LRMM|||||15.05|-28.22|0.6146
71058309|NCT04856930|141621740|SUPERIORITY||LS Mean Difference|-8.9|STANDARD_ERROR_OF_MEAN|12.95||0.4951|TWO_SIDED|90.0|-30.35|12.62||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline average HS Pain NRS as a continuous covariate.|LRMM|||||12.62|-30.35|0.4951
70934999|NCT02660086|141370516|SUPERIORITY||Mean Difference (Net)|5.6|||<|0.001|TWO_SIDED|95.0|4.2|7.0|||Mixed Models Analysis|||Change in healthy purchasing score during 12 month intervention (months 1-12) compared to baseline 12 months||7.0|4.2|<0.001
71108593|NCT00755807|141722558|SUPERIORITY_OR_OTHER|||||||0.942||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Cognitive Function Subsection score.||||||0.942
71108594|NCT00755807|141722558|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Change in Health Subsection score.||||||0.016
71108595|NCT00755807|141722558|SUPERIORITY_OR_OTHER|||||||0.381||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Satisfaction with Sexual Function Subsection score.||||||0.381
71108596|NCT00755807|141722560|SUPERIORITY_OR_OTHER|||||||0.524||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 7). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed model repeated measures (MMRM) Model: Change from Baseline=Baseline+Investigator+Week+Baseline\*Week; participant was treated as random effect.||||||0.524
71108597|NCT00755807|141722560|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 8). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
71108598|NCT00755807|141722560|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 9). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
71108599|NCT00755807|141722560|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 10). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
71108600|NCT00755807|141722560|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 11). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
71108601|NCT00755807|141722560|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 12). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
71108602|NCT00755807|141722560|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 13). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
70851920|NCT00635219|141192185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|1.13||0.1847|TWO_SIDED|95.0|-3.73|0.72||Since p-value \>0.025, hierarchically testing stopped here.|ANCOVA||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||0.72|-3.73|0.1847
70935000|NCT02660086|141370516|SUPERIORITY||Mean Difference (Net)|4.0|||<|0.001|TWO_SIDED|95.0|2.6|5.3|||Mixed Models Analysis|||Change in Healthy Purchasing Score during 12 month follow up (months 13-24) compared to baseline 12 months||5.3|2.6|<0.001
70935001|NCT02660086|141370517|SUPERIORITY||Mean Difference (Net)|1.8|||||TWO_SIDED|95.0|-0.6|4.1||||||Change in HEI scores at 12 months.||4.1|-0.6|
70935002|NCT02660086|141370517|SUPERIORITY||Mean Difference (Net)|1.6|||||TWO_SIDED|95.0|-0.7|3.8||||||Change in HEI scores at 24 months||3.8|-0.7|
70935003|NCT01653509|141370518|SUPERIORITY_OR_OTHER||Least square mean difference|-911.48||||0.3061|TWO_SIDED|95.0|-2712.65|889.69|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between study treatments for TEV.||889.69|-2712.65|0.3061
70935004|NCT01653509|141370518|SUPERIORITY_OR_OTHER||LS Mean Difference|-150.99||||0.4035|TWO_SIDED|95.0|-517.97|215.99|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between treatments for MEV.||215.99|-517.97|0.4035
71058310|NCT03104400|141621763|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|34.5|||<|0.0001|TWO_SIDED|95.0|28.2|40.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||40.7|28.2|<0.0001
70935005|NCT01653509|141370519|SUPERIORITY_OR_OTHER||LS Mean Difference|2.48||||0.0486|TWO_SIDED|95.0|0.02|4.93|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between study treatments for TEV (Day 1 to day 10).||4.93|0.02|0.0486
70935006|NCT01653509|141370519|SUPERIORITY_OR_OTHER||LS Mean Difference|0.38||||0.0799|TWO_SIDED|95.0|-0.05|0.82|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between study treatments for MEV.||0.82|-0.05|0.0799
71058311|NCT03104400|141621763|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|42.3|||<|0.0001|TWO_SIDED|95.0|36.3|48.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||48.3|36.3|<0.0001
71108603|NCT00755807|141722560|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 14). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
70935007|NCT01653509|141370520|SUPERIORITY_OR_OTHER||LS mean difference|2.14||||0.179|TWO_SIDED|95.0|-1.06|5.35|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between study treatments for TEV.||5.35|-1.06|0.1790
70851921|NCT00635219|141192185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|1.12||0.2187|TWO_SIDED|95.0|-3.59|0.82||This dose was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||0.82|-3.59|0.2187
70935008|NCT01653509|141370520|SUPERIORITY_OR_OTHER||LS mean difference|0.37||||0.2446|TWO_SIDED|95.0|-0.27|1.0|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between study treatments for MEV.||1.00|-0.27|0.2446
70935009|NCT01303796|141370526|SUPERIORITY||Hazard Ratio (HR)|1.013|||<|0.0249|TWO_SIDED|95.0|0.837|1.226||one-sided|Kaplan-Meier|||The phase III part planned to randomize 485 patients, about 243 per arm (actual 241 patients per arm), over an estimated period of 24 months. Final analysis would occur at approximately 424 deaths, which was expected to be observed about 43 months after the accrual of the first patient. A stratified log rank analysis would have 90% power to detect a 27.5% reduction in the risk of death, i.e., a hazard ratio of 0.725, between Arm A and Arm C.||1.226|0.837|<0.0249
71108604|NCT00755807|141722560|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 15). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
71058312|NCT03104400|141621764|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Least Squares (LS) Mean Difference|-0.28|||<|0.0001|TWO_SIDED|95.0|-0.35|-0.22|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-0.22|-0.35|<0.0001
71058313|NCT03104400|141621764|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.34|||<|0.0001|TWO_SIDED|95.0|-0.4|-0.27|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-0.27|-0.40|<0.0001
71058314|NCT03104400|141621765|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|31.1|||<|0.0001|TWO_SIDED|95.0|24.7|37.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||37.5|24.7|<0.0001
71058315|NCT03104400|141621765|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|43.1|||<|0.0001|TWO_SIDED|95.0|36.7|49.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||49.6|36.7|<0.0001
71058316|NCT03104400|141621766|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|41.3|||<|0.0001|TWO_SIDED|95.0|32.8|49.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||49.8|32.8|<0.0001
71058317|NCT03104400|141621766|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|41.1|||<|0.0001|TWO_SIDED|95.0|32.5|49.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||49.6|32.5|<0.0001
71058318|NCT03104400|141621767|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.29||||0.0002|TWO_SIDED|95.0|-0.44|-0.14|||ANCOVA|ANCOVA model including treatment and the stratification factor current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-0.14|-0.44|0.0002
71058319|NCT03104400|141621767|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.21||||0.0069|TWO_SIDED|95.0|-0.36|-0.06|||ANCOVA|ANCOVA model including treatment and the stratification factor current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-0.06|-0.36|0.0069
71058320|NCT03104400|141621768|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|24.3|||<|0.0001|TWO_SIDED|95.0|18.8|29.8||Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Cochran-Mantel-Haenszel||Response Rate Difference = Upadacitinib - Placebo|||29.8|18.8|<0.0001
71058321|NCT03104400|141621768|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|33.1|||<|0.0001|TWO_SIDED|95.0|27.4|38.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||38.8|27.4|<0.0001
71058322|NCT03104400|141621769|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|21.3|||<|0.0001|TWO_SIDED|95.0|13.0|29.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||29.7|13.0|<0.0001
71108605|NCT00755807|141722560|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 16). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
70851922|NCT00635219|141192185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|1.14||0.0741|TWO_SIDED|95.0|-4.27|0.2||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||0.20|-4.27|0.0741
70851923|NCT00635219|141192186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.79|STANDARD_ERROR_OF_MEAN|1.13||0.112|TWO_SIDED|95.0|-4.01|0.42||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.42|-4.01|0.1120
71108606|NCT00755807|141722560|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 17). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
71108607|NCT00755807|141722560|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 18). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
71108608|NCT00755807|141722561|SUPERIORITY_OR_OTHER|||||||0.706||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|1-sample t-test of mean change from extension phase baseline to endpoint on BDI-II Question #9 score for all participants who entered extension phase.||||||0.706
71108609|NCT00755807|141722565|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test of mean change from extension phase baseline to endpoint on monocytes.||||||0.035
71108610|NCT00755807|141722566|SUPERIORITY_OR_OTHER|||||||0.042||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test of mean change from extension phase baseline to endpoint on sodium.||||||0.042
70935010|NCT01303796|141370526|SUPERIORITY||Cox Proportional Hazard|1.08|||<|0.0249|TWO_SIDED|95.0|0.86|1.35||one-sided|Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (pre-specified): Presence of antecedent MDS or MPD (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment Levels: No (i.e., de novo) vs Presence of antecedent MDS or MPD"||1.35|0.86|<0.0249
70935011|NCT01303796|141370526|SUPERIORITY|Effects of treatments compared in AML patients with baseline WBC count ≥ 10 x 109/L vs WBC count ≤ 10 x 109/L|Cox Proportional Hazard|1.57|||<|0.0249|TWO_SIDED|95.0|1.12|2.19||one-sided|Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (pre-specified): Baseline peripheral WBC count ≥ 10 x 109/L (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment Levels: Baseline WBC count ≥ 10 x 109/L vs WBC count ≤ 10 x 109/L"||2.19|1.12|<0.0249
70935012|NCT01303796|141370526|SUPERIORITY||Cox Proportional Hazard|1.01|||<|0.0249|TWO_SIDED|95.0|0.77|1.32||one-sided|Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (pre-specified): Baseline bone marrow blast percentage ≥ 50% (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment Levels: Baseline bone marrow blast percentage ≥ 50% vs Blast percentage ≤ 50%"||1.32|0.77|<0.0249
70935013|NCT01303796|141370526|SUPERIORITY||Cox Proportional Hazard|1.27|||<|0.0249|TWO_SIDED|95.0|0.94|1.73|||Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (pre-specified): Unfavorable cytogenetics risk by SWOG (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment Levels: Unfavorable cytogenetics vs other"||1.73|0.94|<0.0249
70935014|NCT01303796|141370526|SUPERIORITY||Cox Proportional Hazard|1.222|||<|0.0249|TWO_SIDED|||||one-sided|Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (post-hoc): Region (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment (Arm A) Levels: EU vs US"||||<0.0249
70935015|NCT01303796|141370526|SUPERIORITY||Cox Proportional Hazard|1.071|||<|0.0249|TWO_SIDED|||||one-sided|Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (post-hoc): Age (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment (Arm A) Levels: ≥ 75 years old vs ≤ 75 years old"||||<0.0249
70935016|NCT01303796|141370526|SUPERIORITY||Cox Proportional Hazard|0.956|||<|0.0249|TWO_SIDED|||||one-sided|Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (post-hoc): Gender (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment (Arm A) Levels: Male vs Female"||||<0.0249
71108611|NCT00755807|141722567|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test of mean change from extension phase baseline to endpoint on total protein.||||||0.036
71108612|NCT00755807|141722568|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on diastolic blood pressure.||||||0.320
71108613|NCT00755807|141722568|SUPERIORITY_OR_OTHER|||||||0.182||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on systolic blood pressure.||||||0.182
71108614|NCT00755807|141722569|SUPERIORITY_OR_OTHER|||||||0.032||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on pulse rate.||||||0.032
70935017|NCT01303796|141370526|SUPERIORITY||||||<|0.0249||||||one-sided|Log Rank|Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.||"Subgroup analyses (post-hoc): ECOG status (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment (Arm A) Levels: Status 2 vs \< 2"||||<0.0249
70935018|NCT01303796|141370526|SUPERIORITY||||||<|0.0249||||||one-sided|Log Rank|Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.||"Subgroup analyses (post-hoc): HCT-CI score (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment Levels: HCT-CI score 0-2 vs HCT-CI score \>2"||||<0.0249
70935019|NCT01303796|141370527|SUPERIORITY||Cox Proportional Hazard|1.34||||0.1468|TWO_SIDED|95.0|0.645|2.782|||Fisher Exact|||||2.782|0.645|0.1468
70935020|NCT01303796|141370532|SUPERIORITY|||||||0.0416|||||||Wilcoxon (Mann-Whitney)|||||||0.0416
70935021|NCT01303796|141370533|SUPERIORITY|||||||0.1568|||||||Wilcoxon (Mann-Whitney)|||||||0.1568
71058323|NCT03104400|141621769|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|25.3|||<|0.0001|TWO_SIDED|95.0|16.9|33.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||33.7|16.9|<0.0001
71058324|NCT03104400|141621770|NON_INFERIORITY|"Non-inferiority of each upadacitinib dose versus adalimumab was assessed using Koch's 3-arm approach; non-inferiority was achieved if upadacitinib preserved at least 50% of the placebo-subtracted adalimumab effect.~The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path."|Percent Adalimumab Effect Preservation|119.381|||<|0.0001|TWO_SIDED|95.0|97.987|147.942|||Koch 3-Arm Test||The percent of adalimumab effect preservation is the point estimate of 3-arm non-inferiority analysis, which is calculated by (Upadacitinib - Placebo) / (Adalimumab - Placebo) \* 100.|||147.942|97.987|<0.0001
71058325|NCT03104400|141621770|NON_INFERIORITY|"Non-inferiority of each upadacitinib dose versus adalimumab was assessed using Koch's 3-arm approach; non-inferiority was achieved if upadacitinib preserved at least 50% of the placebo-subtracted adalimumab effect.~The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path."|Percent Adalimumab Effect Preservation|146.604|||<|0.0001|TWO_SIDED|95.0|122.817|180.398|||Koch 3-Arm Test||The percent of adalimumab effect preservation is the point estimate of 3-arm non-inferiority analysis, which is calculated by (Upadacitinib - Placebo) / (Adalimumab - Placebo) \* 100.|||180.398|122.817|<0.0001
71058326|NCT03104400|141621771|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|4.67|||<|0.0001|TWO_SIDED|95.0|3.67|5.67|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||5.67|3.67|<0.0001
71058327|NCT03104400|141621771|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|5.72|||<|0.0001|TWO_SIDED|95.0|4.71|6.72|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||6.72|4.71|<0.0001
71108615|NCT00755807|141722570|SUPERIORITY_OR_OTHER|||||||0.151||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on weight.||||||0.151
70935022|NCT01303796|141370534|SUPERIORITY||Cox Proportional Hazard|1.013|||<|0.0249|TWO_SIDED|95.0|0.837|1.226||one-sided|Log Rank|||||1.226|0.837|<0.0249
70935023|NCT01711294|141370546|SUPERIORITY|Sample sizes were calculated using two-sample t-test for the primary endpoint and z-test for the secondary endpoint with power of 80% and two-sided alpha of 0.05. Hochberg step up procedure was used to adjust for multiple comparison. A p-value \< 0.05 was considered statistically significant.||||||0.84||||||Hochberg step up procedure was used to adjust for multiple comparison.|Wilcoxon (Mann-Whitney)|Wilcoxon was used instead of t-test because the data was not normally distributed.||Study hypothesizes that aspiration % in the 19G Flex and 19G arms would be superior by at least 10% to 22G arm, and aspiration success rate of 19G Flex would be at least 16% greater than 22G and 19G arms. Sample size calculation was performed based on the above hypotheses reached by a consensus of all collaborators and adjusted a priori.||||0.84
71108616|NCT03531814|141722574|OTHER|||||||0.006||||||The Greenhouse-Geisser correction was used because Mauchly's test of sphericity was significant. The reported p-value represents the probability of the differences in the averages of adherence assessment methods for cycles 1-4.|ANOVA|||||||0.006
70935024|NCT02605174|141370562|SUPERIORITY||Odds Ratio (OR)|1.5||||0.003|TWO_SIDED|95.0|1.1|1.9|||Regression, Logistic|||||1.9|1.1|0.003
70935025|NCT02605174|141370562|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.3|2.2|||Regression, Logistic|||||2.2|1.3|<0.001
70935026|NCT02605174|141370562|SUPERIORITY||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.8|3.1|||Regression, Logistic|||||3.1|1.8|<0.001
70935027|NCT02605174|141370563|SUPERIORITY||Odds Ratio (OR)|1.4||||0.009|TWO_SIDED|95.0|1.1|1.8|||Regression, Logistic|||||1.8|1.1|0.009
70935028|NCT02605174|141370563|SUPERIORITY||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.2|2.0|||Regression, Logistic|||||2.0|1.2|<0.001
70935029|NCT02605174|141370563|SUPERIORITY||Odds Ratio (OR)|1.9|||<|0.001|TWO_SIDED|95.0|1.4|2.4|||Regression, Logistic|||||2.4|1.4|<0.001
70935030|NCT02605174|141370564|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.3|2.2|||Regression, Logistic|||||2.2|1.3|<0.001
70935031|NCT02605174|141370564|SUPERIORITY||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.7|2.9|||Regression, Logistic|||||2.9|1.7|<0.001
70851924|NCT00635219|141192186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63|STANDARD_ERROR_OF_MEAN|1.13||0.1487|TWO_SIDED|95.0|-3.85|0.59||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.59|-3.85|0.1487
71108617|NCT03531814|141722574|OTHER|||||||0.021||||||The Greenhouse-Geisser correction was used because Mauchly's test of sphericity was significant. The reported p-value represents the probability of the differences in the averages of adherence assessment methods for cycles 5-8.|ANOVA|||||||0.021
70935032|NCT02605174|141370564|SUPERIORITY||Odds Ratio (OR)|2.4|||<|0.001|TWO_SIDED|95.0|1.8|3.1|||Regression, Logistic|||||3.1|1.8|<0.001
70935033|NCT02605174|141370566|SUPERIORITY||Odds Ratio (OR)|0.7||||0.002|TWO_SIDED|95.0|0.5|0.9|||Regression, Logistic|||||0.9|0.5|0.002
71025396|NCT01533428|141558436|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.2||||0.027|TWO_SIDED|95.0|-13.5|-0.8|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 4.||-0.8|-13.5|0.027
71025397|NCT01533428|141558436|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.3||||0.024|TWO_SIDED|95.0|-13.6|-1.0|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 5.||-1.0|-13.6|0.024
71025398|NCT01533428|141558436|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.3||||0.051|TWO_SIDED|95.0|-12.6|0.0|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 6.||0.0|-12.6|0.051
71025399|NCT01533428|141558436|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.1||||0.012|TWO_SIDED|95.0|-14.4|-1.8|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 7.||-1.8|-14.4|0.012
71025400|NCT01533428|141558436|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.2||||0.026|TWO_SIDED|95.0|-13.5|-0.8|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 8.||-0.8|-13.5|0.026
71025401|NCT01533428|141558436|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.9||||0.032|TWO_SIDED|95.0|-13.2|-0.6|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 9.||-0.6|-13.2|0.032
71025402|NCT01533428|141558436|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.5||||0.02|TWO_SIDED|95.0|-13.9|-1.2|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 10.||-1.2|-13.9|0.020
71025403|NCT01533428|141558436|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.4||||0.022|TWO_SIDED|95.0|-13.7|-1.1|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 11.||-1.1|-13.7|0.022
71025404|NCT01533428|141558436|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.0||||0.005|TWO_SIDED|95.0|-15.3|-2.7|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 12.||-2.7|-15.3|0.005
71025405|NCT01533428|141558438|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.108|TWO_SIDED|95.0|0.9|2.2|||Regression, Logistic|Analysis of regression logistics model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Percentage of participants with 30% reduction in average daily pain score assessed in Weeks 2-8. The comparison of the odds ratio of capsaicin 8% to placebo for percent change from baseline was performed using a logistic regression model.||2.2|0.9|0.108
71025406|NCT01533428|141558438|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.05|TWO_SIDED|95.0|1.0|2.4|||Regression, Logistic|Analysis of regression logistics model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Percentage of participants with 30% reduction in average daily pain score assessed in Weeks 2-12. The comparison of the odds ratio of capsaicin 8% to placebo for percent change from baseline was performed using a logistic regression model.||2.4|1.0|0.050
71025407|NCT01533428|141558439|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.403|TWO_SIDED|95.0|0.7|2.1|||Regression, Logistic|Analysis of regression logistics model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Percentage of participants with 50% reduction in average daily pain score assessed in Weeks 2-8. The comparison of the odds ratio of capsaicin 8% to placebo for percent change from baseline was performed using a logistic regression model.||2.1|0.7|0.403
71025408|NCT01533428|141558439|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.446|TWO_SIDED|95.0|0.7|2.0|||Regression, Logistic|Analysis of regression logistics model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Percentage of participants with 50% reduction in average daily pain score assessed in Weeks 2-12. The comparison of the odds ratio of capsaicin 8% to placebo for percent change from baseline was performed using a logistic regression model.||2.0|0.7|0.446
71108618|NCT03531814|141722574|OTHER|||||||0.034||||||The Greenhouse-Geisser correction was used because Mauchly's test of sphericity was significant. The reported p-value represents the probability of the differences in the averages of adherence assessment methods for cycles 9-12.|ANOVA|||||||.034
71108619|NCT03531814|141722574|OTHER|||||||0.04||||||The Greenhouse-Geisser correction was used because Mauchly's test of sphericity was significant. The reported p-value represents the probability of the differences in the averages of adherence assessment methods for cycles 13-18.|ANOVA|||||||.040
70851925|NCT00635219|141192186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11|STANDARD_ERROR_OF_MEAN|1.12||0.3246|TWO_SIDED|95.0|-3.31|1.1||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.10|-3.31|0.3246
70851926|NCT00635219|141192186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.47|STANDARD_ERROR_OF_MEAN|1.13||0.0298|TWO_SIDED|95.0|-4.7|-0.24||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||-0.24|-4.70|0.0298
70935034|NCT02605174|141370566|SUPERIORITY||Odds Ratio (OR)|0.5|||<|0.001|TWO_SIDED|95.0|0.4|0.7|||Regression, Logistic|||||0.7|0.4|<0.001
71058328|NCT03104400|141621772|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|3.5|||<|0.0001|TWO_SIDED|95.0|2.4|4.7|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||4.7|2.4|<0.0001
71108620|NCT03531814|141722575|OTHER||Spearman's correlation|-0.21||||0.536|TWO_SIDED|95.0|-0.729|0.463||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 1-4.|Spearman correlation (non-parametric)|||||0.463|-0.729|0.536
71108621|NCT03531814|141722575|OTHER||Spearman's correlation|0.134||||0.713|TWO_SIDED|95.0|-0.557|0.715||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 5-8.|Spearman correlation (non-parametric)|||||0.715|-0.557|.713
71108622|NCT03531814|141722575|OTHER||Spearman's correlation|0.095||||0.823|TWO_SIDED|95.0|-0.668|0.761||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 9-12.|Spearman correlation (non-parametric)|||||0.761|-0.668|.823
70851927|NCT00635219|141192187|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.137|TWO_SIDED|95.0|0.9|2.23||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||2.23|0.90|0.1370
71108623|NCT03531814|141722575|OTHER||Spearman's correlation|0.333||||0.42|TWO_SIDED|95.0|-0.505|0.848||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 13-18.|Spearman correlation (non-parametric)|||||0.848|-0.505|.420
70935035|NCT02605174|141370566|SUPERIORITY||Odds Ratio (OR)|0.3|||<|0.001|TWO_SIDED|95.0|0.3|0.4|||Regression, Logistic|||||0.4|0.3|<0.001
71108624|NCT03531814|141722576|OTHER||Spearman's correlation|-0.333||||0.317|TWO_SIDED|95.0|-0.785|0.352||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 1-4.|Spearman correlation (non-parametric)|||||0.352|-0.785|0.317
70935036|NCT02605174|141370567|SUPERIORITY||Odds Ratio (OR)|1.0||||0.917|TWO_SIDED|95.0|0.7|1.5|||Regression, Logistic|||||1.5|0.7|0.917
71108625|NCT03531814|141722576|OTHER||Spearman's correlation|-0.309||||0.385|TWO_SIDED|95.0|-0.794|0.416||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 5-8.|Spearman correlation (non-parametric)|||||0.416|-0.794|.385
71108626|NCT03531814|141722576|OTHER||Spearman's correlation|-0.259||||0.535|TWO_SIDED|95.0|-0.824|0.563||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 9-12.|Spearman correlation (non-parametric)|||||0.563|-0.824|.535
71108627|NCT03531814|141722576|OTHER||Spearman's correlation|-0.222||||0.597|TWO_SIDED|95.0|-0.811|0.589||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 13-18.|Spearman correlation (non-parametric)|||||0.589|-0.811|.597
70851928|NCT00635219|141192187|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.54||||0.0664|TWO_SIDED|95.0|0.97|2.43||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||2.43|0.97|0.0664
70851929|NCT00635219|141192187|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.2023|TWO_SIDED|95.0|0.85|2.12||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||2.12|0.85|0.2023
70851930|NCT00635219|141192187|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.0765|TWO_SIDED|95.0|0.96|2.4||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||2.40|0.96|0.0765
70851931|NCT00635219|141192188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1436|TWO_SIDED|95.0|-0.47|0.07||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.07|-0.47|0.1436
70851932|NCT00635219|141192188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.2114|TWO_SIDED|95.0|-0.44|0.1||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.10|-0.44|0.2114
70851933|NCT00635219|141192188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1389|TWO_SIDED|95.0|-0.47|0.07||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.07|-0.47|0.1389
70851934|NCT00635219|141192188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.14||0.1271|TWO_SIDED|95.0|-0.48|0.06||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.06|-0.48|0.1271
70851935|NCT00635219|141192189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|1.49||0.4421|TWO_SIDED|95.0|-4.08|1.79||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.79|-4.08|0.4421
70851936|NCT00635219|141192189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|1.49||0.4399|TWO_SIDED|95.0|-4.07|1.77||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.77|-4.07|0.4399
70851937|NCT00635219|141192189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|1.54||0.8093|TWO_SIDED|95.0|-2.65|3.4||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||3.40|-2.65|0.8093
70851938|NCT00635219|141192189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6|STANDARD_ERROR_OF_MEAN|1.53||0.0897|TWO_SIDED|95.0|-5.61|0.41||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.41|-5.61|0.0897
70935037|NCT02605174|141370567|SUPERIORITY||Odds Ratio (OR)|0.7||||0.129|TWO_SIDED|95.0|0.5|1.1|||Regression, Logistic|||||1.1|0.5|0.129
70935038|NCT02605174|141370567|SUPERIORITY||Odds Ratio (OR)|0.8||||0.456|TWO_SIDED|95.0|0.6|1.3|||Regression, Logistic|||||1.3|0.6|0.456
70935039|NCT02605174|141370569|SUPERIORITY||Odds Ratio (OR)|0.9||||0.522|TWO_SIDED|95.0|0.7|1.2|||Regression, Logistic|||||1.2|0.7|0.522
71108628|NCT03531814|141722577|OTHER||Spearman's correlation|-0.215||||0.526|TWO_SIDED|95.0|-0.731|0.459||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 1-4.|Spearman correlation (non-parametric)|||||0.459|-0.731|0.526
70851939|NCT00635219|141192190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.98||0.6748|TWO_SIDED|95.0|-2.35|1.52||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.52|-2.35|0.6748
70851940|NCT00635219|141192190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.99||0.0871|TWO_SIDED|95.0|-3.64|0.25||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.25|-3.64|0.0871
70851941|NCT00635219|141192190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99|STANDARD_ERROR_OF_MEAN|0.99||0.3186|TWO_SIDED|95.0|-2.94|0.96||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.96|-2.94|0.3186
71025409|NCT01533428|141558440|SUPERIORITY_OR_OTHER|||||||0.072|TWO_SIDED||||||Cochran-Mantel-Haenszel|Analysis of Cochran-Mantel-Haenszel test model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for counts by category using a Cochran-Mantel-Haenszel test.||||0.072
71058329|NCT03104400|141621772|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|4.3|||<|0.0001|TWO_SIDED|95.0|3.1|5.5|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||5.5|3.1|<0.0001
71025410|NCT01533428|141558441|SUPERIORITY_OR_OTHER|||||||0.075|TWO_SIDED||||||Cochran-Mantel-Haenszel|Analysis of Cochran-Mantel-Haenszel test model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for counts by category using a Cochran-Mantel-Haenszel test.||||0.075
71058330|NCT03104400|141621773|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|5.6||||0.0815|TWO_SIDED|95.0|-0.6|11.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Adalimumab|||11.8|-0.6|0.0815
71058331|NCT03104400|141621773|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|13.5|||<|0.0001|TWO_SIDED|95.0|7.5|19.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Adalimumab|||19.4|7.5|<0.0001
71025411|NCT01533428|141558442|SUPERIORITY_OR_OTHER|||||||0.169|TWO_SIDED||||||Cochran-Mantel-Haenszel|Analysis of Cochran-Mantel-Haenszel test model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for counts by category using a Cochran-Mantel-Haenszel test.||||0.169
71025412|NCT01533428|141558443|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.32|TWO_SIDED|95.0|-1.6|5.0|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||The statistical comparison between Baseline and Week 8 was made using two-sided tests at the 5% significance level.||5.0|-1.6|0.320
71025413|NCT01533428|141558443|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2||||0.473|TWO_SIDED|95.0|-2.1|4.5|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||The statistical comparison between Baseline and Week 12 was made using two-sided tests at the 5% significance level.||4.5|-2.1|0.473
71025414|NCT01533428|141558443|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.514|TWO_SIDED|95.0|-4.4|2.2|||ANCOVA|||The statistical comparison between Baseline and Week 2 was made using two-sided tests at the 5% significance level.||2.2|-4.4|0.514
71025415|NCT01533428|141558444|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.719|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 2 was completed using ANCOVA model.||0.7|-0.5|0.719
71025416|NCT01533428|141558444|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.334|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 8 was completed using ANCOVA model.||0.3|-0.8|0.334
71025417|NCT01533428|141558444|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.726|TWO_SIDED|95.0|-0.7|0.5|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 12 was completed using ANCOVA model.||0.5|-0.7|0.726
71058332|NCT03104400|141621774|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|36.8|||<|0.0001|TWO_SIDED|95.0|25.7|47.9||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||47.9|25.7|<0.0001
71058333|NCT03104400|141621774|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|39.8|||<|0.0001|TWO_SIDED|95.0|28.8|50.9||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||50.9|28.8|<0.0001
71077944|NCT02913105|141664399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.9577|TWO_SIDED|90.0|0.89|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 112 (EOS)||1.12|0.89|0.9577
70851942|NCT00635219|141192190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|1.01||0.0768|TWO_SIDED|95.0|-3.79|0.19||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.19|-3.79|0.0768
71108629|NCT03531814|141722577|OTHER||Spearman's correlation|0.049||||0.894|TWO_SIDED|95.0|-0.613|0.67||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 5-8.|Spearman correlation (non-parametric)|||||0.670|-0.613|.894
71108630|NCT03531814|141722577|OTHER||Spearman's correlation|-0.048||||0.911|TWO_SIDED|95.0|-0.74|0.694||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 9-12|Spearman correlation (non-parametric)|||||0.694|-0.740|.911
71108631|NCT03531814|141722577|OTHER||Spearman's correlation|-0.167||||0.693|TWO_SIDED|95.0|-0.79|0.626||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 13-18|Spearman correlation (non-parametric)|||||0.626|-0.790|.693
71058334|NCT03104400|141621775|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|0.0||||0.897|TWO_SIDED|95.0|-0.3|0.3||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||0.3|-0.3|0.8970
71058335|NCT03104400|141621775|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.5||||0.0028|TWO_SIDED|95.0|-0.7|-0.2||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||-0.2|-0.7|0.0028
71108632|NCT03531814|141722578|OTHER||Spearman's correlation|-0.607||||0.048|TWO_SIDED|95.0|-0.889|0.009||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 1-4.|Spearman correlation (non-parametric)|||||0.009|-0.889|0.048
71108633|NCT03531814|141722578|OTHER||Spearman's correlation|-0.658||||0.038|TWO_SIDED|95.0|-0.914|-0.027||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 5-8.|Spearman correlation (non-parametric)|||||-0.027|-0.914|0.038
71108634|NCT03531814|141722578|OTHER||Spearman's correlation|-0.708||||0.5|TWO_SIDED|95.0|-0.945|0.02||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 9-12.|Spearman correlation (non-parametric)|||||0.020|-0.945|0.50
71108635|NCT03531814|141722578|OTHER||Spearman's correlation|-0.878||||0.004|TWO_SIDED|95.0|-0.979|-0.435||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 13-18.|Spearman correlation (non-parametric)|||||-0.435|-0.979|0.004
71108636|NCT03531814|141722579|OTHER||Spearman's correlation|0.293||||0.382|TWO_SIDED|95.0|-0.39|0.768||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 1-4.|Spearman correlation (non-parametric)|||||0.768|-0.390|0.382
71108637|NCT03531814|141722579|OTHER||Spearman's correlation|0.278||||0.436|TWO_SIDED|95.0|-0.444|0.781||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 5-8.|Spearman correlation (non-parametric)|||||0.781|-0.444|0.436
71108638|NCT03531814|141722579|OTHER||Spearman's correlation|0.229||||0.586|TWO_SIDED|95.0|-0.585|0.813||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 9-12.|Spearman correlation (non-parametric)|||||0.813|-0.585|0.586
71108639|NCT03531814|141722579|OTHER||Spearman's correlation|0.53||||0.177|TWO_SIDED|95.0|-0.302|0.904||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 13-18.|Spearman correlation (non-parametric)|||||0.904|-0.302|0.177
71108640|NCT03531814|141722581|OTHER||Spearman's correlation|-0.576||||0.063|TWO_SIDED|95.0|-0.879|0.056||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 1-4.|Spearman correlation (non-parametric)|||||0.056|-0.879|0.063
71108641|NCT03531814|141722581|OTHER||Spearman's correlation|-0.68||||0.031|TWO_SIDED|95.0|-0.92|-0.066||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 5-8.|Wilcoxon (Mann-Whitney)|||||-0.066|-0.920|0.031
71108642|NCT03531814|141722581|OTHER||Spearman's correlation|-0.835||||0.01|TWO_SIDED|95.0|-0.971|-0.292||The reported p-value represents the strength of the relationship between the variables at cycles 9-12.|Spearman correlation (non-parametric)|||||-0.292|-0.971|0.010
71108643|NCT03531814|141722581|OTHER||Spearman's correlation|-0.933|||<|0.001|TWO_SIDED|95.0|-0.989|-0.652||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 13-18.|Spearman correlation (non-parametric)|||||-0.652|-0.989|<0.001
70851943|NCT00635219|141192191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13||||0.6258|TWO_SIDED|95.0|0.7|1.81||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||1.81|0.70|0.6258
71108644|NCT03531814|141722582|OTHER||Spearman's correlation|-0.035||||0.919|TWO_SIDED|95.0|-0.634|0.591||The reported p-value represents the strength of the relationship between the variables for cycles 1-4.|Spearman correlation|||||0.591|-0.634|0.919
71108645|NCT03531814|141722582|OTHER||Spearman's correlation|0.227||||0.528|TWO_SIDED|95.0|-0.487|0.759||The reported p-value represents the strength of the relationship between the variables for cycles 5-8.|Spearman correlation|||||0.759|-0.487|0.528
70851944|NCT00635219|141192191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.7178|TWO_SIDED|95.0|0.68|1.76||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||1.76|0.68|0.7178
71108646|NCT03531814|141722582|OTHER||Spearman's correlation|0.179||||0.672|TWO_SIDED|95.0|-0.618|0.794||The reported p-value represents the strength of the relationship between the variables for cycles 9-12.|Spearman correlation|||||0.794|-0.618|0.672
71108647|NCT03531814|141722582|OTHER||Spearman's correlation|0.041||||0.923|TWO_SIDED|95.0|-0.697|0.737||The reported p-value represents the strength of the relationship between the variables for cycles 13-18.|Spearman correlation|||||0.737|-0.697|0.923
71108648|NCT03531814|141722583|OTHER||Spearman's correlation|-0.638||||0.035|TWO_SIDED|95.0|-0.899|-0.041||The reported p-value represents the strength of the relationship between the variables for cycles 1-4.|Spearman correlation|||||-0.041|-0.899|0.035
70935040|NCT02605174|141370569|SUPERIORITY||Odds Ratio (OR)|1.1||||0.622|TWO_SIDED|95.0|0.8|1.4|||Regression, Logistic|||||1.4|0.8|0.622
70935041|NCT02605174|141370569|SUPERIORITY||Odds Ratio (OR)|1.0||||0.992|TWO_SIDED|95.0|0.8|1.3|||Regression, Logistic|||||1.3|0.8|0.992
70935042|NCT02605174|141370570|SUPERIORITY||Odds Ratio (OR)|1.4||||0.008|TWO_SIDED|95.0|1.1|1.7|||Regression, Logistic|||||1.7|1.1|0.008
70935043|NCT02605174|141370570|SUPERIORITY||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.3|2.0|||Regression, Logistic|||||2.0|1.3|<0.001
70935044|NCT02605174|141370570|SUPERIORITY||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.3|2.1|||Regression, Logistic|||||2.1|1.3|<0.001
70935045|NCT02605174|141370571|SUPERIORITY||Odds Ratio (OR)|1.4||||0.007|TWO_SIDED|95.0|1.1|1.7|||Regression, Logistic|||||1.7|1.1|0.007
70935046|NCT02605174|141370571|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.3|2.1|||Regression, Logistic|||||2.1|1.3|<0.001
70935047|NCT02605174|141370571|SUPERIORITY||Odds Ratio (OR)|1.8|||<|0.001|TWO_SIDED|95.0|1.4|2.3|||Regression, Logistic|||||2.3|1.4|<0.001
71025418|NCT01533428|141558445|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.841|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 2 was completed using ANCOVA model.||0.5|-0.6|0.841
71025419|NCT01533428|141558445|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.171|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 8 was completed using ANCOVA model.||0.2|-0.9|0.171
71025420|NCT01533428|141558445|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.595|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 12 was completed using ANCOVA model.||0.4|-0.7|0.595
71025421|NCT01533428|141558447|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.0||||0.03|TWO_SIDED|95.0|-17.2|-0.9|||ANCOVA|Analysis of covariance model including treatment,gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||All statistical comparisons were made using two-sided tests at the 5% significance level.||-0.9|-17.2|0.030
71025422|NCT01533428|141558447|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.5||||0.02|TWO_SIDED|95.0|-17.4|-1.5|||ANCOVA|Analysis of covariance model including treatment,gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||All statistical comparisons were made using two-sided tests at the 5% significance level.||-1.5|-17.4|0.020
71025423|NCT01364870|141558453|SUPERIORITY|||||||0.016||||||The p value was adjusted using Bonferroni's method to account for the multiple comparisons.|Kruskal-Wallis|||There were instances of missing data due to patient time restraints and patient refusal.||||0.016
71025424|NCT01364870|141558454|SUPERIORITY|||||||0.008||||||P-value was adjusted using Bonferroni's method to account for multiple comparisons.|Kruskal-Wallis|||There were instances of missing data due to patient time restraints and patient refusal.||||0.008
71025425|NCT01513551|141558468|OTHER||Risk Difference (RD)|6.8|||||TWO_SIDED|95.0|-1.4|15.0|||Miettinen & Nurminen|||||15.0|-1.4|
71025426|NCT01513551|141558468|OTHER||Risk Difference (RD)|9.5|||||TWO_SIDED|95.0|1.1|17.7|||Miettinen & Nurminen|||||17.7|1.1|
71025427|NCT00094302|141558477|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.14|TWO_SIDED|95.0|0.77|1.04||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|Composite endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 320 subjects in the Spironolactone group and 351 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.||1.04|0.77|0.14
71025428|NCT00094302|141558478|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.35|TWO_SIDED|95.0|0.73|1.12||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 336 subjects (160 in the Spironolactone group and 176 in the Placebo group) with a confirmed event."||1.12|0.73|0.35
71025429|NCT00094302|141558479|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.48|TWO_SIDED|95.0|0.14|2.5||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 8 subjects (3 in the Spironolactone group and 5 in the Placebo group) with a confirmed event."||2.50|0.14|0.48
71025430|NCT00094302|141558480|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.04|TWO_SIDED|95.0|0.69|0.99||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 451 subjects (206 in the Spironolactone group and 245 in the Placebo group) who have been confirmed to have experienced the event"||0.99|0.69|0.04
71025431|NCT00094302|141558481|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.29|TWO_SIDED|95.0|0.77|1.08||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|Endpoint compared by trial arm using logrank test of time to event from randomization. Subjects who did not experience endpoint were censored at time of last contact. Attempts were made to determine vital status as of each subject's last potential visit, based on randomization, even if the subject ended study participation before then. This outcome was adjudicated. There were 252 events over 6,022 patient-years in Spironolactone arm and 274 events over 5,981 patient-years in Placebo arm.||1.08|0.77|0.29
70935048|NCT03737110|141370575|SUPERIORITY||Hazard Ratio (HR)|0.04|||<|0.0001|TWO_SIDED|95.0|0.01|0.18||Two-sided p-value is from the log-rank test stratified by oral corticosteroid use at Run-In Baseline.|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by oral corticosteroid use at run-in baseline.|||0.18|0.01|<0.0001
70935049|NCT03737110|141370576|SUPERIORITY||Odds Ratio (OR)|12.727||||0.0002|TWO_SIDED|95.0|2.438|66.428||95% confidence interval (CI) and p-value were analyzed using a Cochran-Mantel-Haenszel test adjusted by oral corticosteroid use and diagnosis of recurrent idiopathic pericarditis at run-in baseline.|Cochran-Mantel-Haenszel|||||66.428|2.438|0.0002
70935050|NCT03737110|141370576|SUPERIORITY||Difference in percentages|61.0|||||TWO_SIDED|95.0|36.7|85.2|||||Differences between percentages are reported in percentage points. The 95% confidence intervals for the differences in percentages were based on a normal approximation.|||85.2|36.7|
70935051|NCT03737110|141370577|SUPERIORITY||Least squares (LS) mean difference|51.2|||<|0.0001|TWO_SIDED|95.0|34.5|68.0||Two-sided p-value calculated using analysis of covariance with treatment, randomization strata and run-in baseline NRS weekly average category (NRS ≤ 2 versus NRS \>2) as covariates.|ANCOVA||Least squares mean difference (rilonacept - placebo)|||68.0|34.5|< 0.0001
70935052|NCT03737110|141370578|SUPERIORITY||Odds Ratio (OR)|10.0||||0.0006|TWO_SIDED|95.0|2.136|46.826||95% CI and p-value are analyzed using a Cochran-Mantel-Haenszel test adjusted by oral corticosteroid use and diagnosis of recurrent idiopathic pericarditis at RI baseline.|Cochran-Mantel-Haenszel|||||46.826|2.136|0.0006
71025432|NCT00094302|141558482|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.28|TWO_SIDED|95.0|0.8|1.06||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|Composite endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. Component endpoints were adjudicated by the TOPCAT clinical endpoints committee. There were 382 subjects in Spironolactone group and 404 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.||1.06|0.80|0.28
71025433|NCT00094302|141558483|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.15|TWO_SIDED|95.0|0.76|1.04||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|Endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. Component endpoints were adjudicated by the TOPCAT clinical endpoints committee. There were 291 subjects in Spironolactone group and 320 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.||1.04|0.76|0.15
71025434|NCT00094302|141558484|SUPERIORITY_OR_OTHER||incidence rate ratio|0.75||||0.03|TWO_SIDED|95.0|0.58|0.97||No covariate adjustment|Negative binomial regression||Spironolactone compared to Placebo|There were a total of 869 confirmed heart failure hospitalizations (394 in the Spironolactone group and 475 in the Placebo group) during the 11,471 person-years collected over the course of the TOPCAT trial (5,755 person-years in the Spironolactone group and 5,716 person-years in the Placebo group). The incidence rate of heart failure hospitalizations for each treatment group was compared using a negative binomial regression with a p-value threshold of 0.05 for statistical significance.||0.97|0.58|0.03
70851945|NCT00635219|141192191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8651|TWO_SIDED|95.0|0.59|1.55||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||1.55|0.59|0.8651
70935053|NCT03737110|141370578|SUPERIORITY||Difference in percentages|56.0|||||TWO_SIDED|95.0|30.6|81.3|||||Differences between percentages are reported in percentage points. The 95% confidence intervals for the differences in percentages were based on a normal approximation.|||81.3|30.6|
70935054|NCT03737110|141370579|SUPERIORITY||Odds Ratio (OR)|8.37||||0.0022|TWO_SIDED|95.0|1.317|53.188||95% CI and p-value were analyzed using a Cochran-Mantel-Haenszel test adjusted by oral corticosteroid use and diagnosis of recurrent idiopathic pericarditis at run-in baseline.|Cochran-Mantel-Haenszel|||||53.188|1.317|0.0022
70935055|NCT03737110|141370580|SUPERIORITY||Odds Ratio (OR)|10.906|||<|0.0001|TWO_SIDED|95.0|3.051|38.981||95% CI and p-value were analyzed using a Cochran-Mantel-Haenszel test adjusted by oral corticosteroid use and diagnosis of recurrent idiopathic pericarditis at run-in baseline.|Cochran-Mantel-Haenszel|||||38.981|3.051|< 0.0001
70935056|NCT03737110|141370581|SUPERIORITY||LS mean difference|51.9|||<|0.0001|TWO_SIDED|95.0|33.8|70.1||Two-sided p-value calculated using analysis of covariance with treatment, randomization strata and run-in baseline NRS weekly average category (NRS ≤ 2 versus NRS \>2) as covariates.|ANCOVA||Least squares mean difference (rilonacept - placebo)|||70.1|33.8|< 0.0001
70935057|NCT03737110|141370582|SUPERIORITY||LS mean difference|40.5|||<|0.0001|TWO_SIDED|95.0|25.3|55.8||Two-sided p-value calculated using analysis of covariance with treatment, randomization strata and run-in baseline NRS weekly average category (NRS ≤ 2 versus NRS \>2) as covariates.|ANCOVA||Least squares mean difference (rilonacept - placebo)|||55.8|25.3|< 0.0001
70935058|NCT03737110|141370583|SUPERIORITY||Odds Ratio (OR)|30.522||||0.0002|TWO_SIDED|95.0|4.262|218.552||95% CI and p-value are analyzed using a Cochran-Mantel-Haenszel (CMH) test adjusted by oral corticosteroid use at RI baseline.|Cochran-Mantel-Haenszel|||||218.552|4.262|0.0002
70935059|NCT03737110|141370584|SUPERIORITY||Odds Ratio (OR)|14.432|||<|0.0001|TWO_SIDED|95.0|3.439|60.574||95% CI and p-value are analyzed using a Cochran-Mantel-Haenszel test adjusted by oral corticosteroid use and diagnosis of recurrent idiopathic pericarditis at RI baseline.|Cochran-Mantel-Haenszel|||||60.574|3.439|< 0.0001
70935060|NCT03737110|141370585|SUPERIORITY||Difference|75.7|||<|0.0001|TWO_SIDED|95.0|56.8|94.6|||normal approximation|||||94.6|56.8|< 0.0001
70935061|NCT03737110|141370586|SUPERIORITY||Hazard Ratio (HR)|0.13|||<|0.0001|TWO_SIDED|95.0|0.05|0.32||Two-sided p-value is from the log-rank test stratified by oral corticosteroid use at run-in baseline.|Log Rank||Calculated based on a Cox proportional hazards model with treatment as covariate and stratified by oral corticosteroid use at run-in baseline.|||0.32|0.05|< 0.0001
70935062|NCT03737110|141370587|SUPERIORITY||Hazard Ratio (HR)|0.07|||<|0.0001|TWO_SIDED|95.0|0.02|0.22||Two-sided p-value is from the log-rank test stratified by oral corticosteroid use at run-in baseline.|Log Rank||Calculated based on a Cox proportional hazards model with treatment as covariate and stratified by oral corticosteroid use at run-in baseline.|||0.22|0.02|< 0.0001
70935063|NCT03737110|141370588|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.7447|TWO_SIDED|95.0|0.12|4.46||Two-sided p-value is from the log-rank test without stratification by randomization strata.|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and without stratification by randomization strata.|||4.46|0.12|0.7447
70935064|NCT03737110|141370589|SUPERIORITY||Hazard Ratio (HR)|0.36||||0.2066|TWO_SIDED|95.0|0.07|1.87||Two-sided p-value is from the log-rank test without stratification by randomization strata.|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and without stratification by randomization strata.|||1.87|0.07|0.2066
71025435|NCT00094302|141558485|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.82|TWO_SIDED|95.0|0.67|1.38||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|Composite endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. Component endpoints were adjudicated by the TOPCAT clinical endpoints committee. There were 58 subjects in the Spironolactone group and 60 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.||1.38|0.67|0.82
71025436|NCT00094302|141558486|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.76|TWO_SIDED|95.0|0.64|1.83||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 56 subjects (29 in the Spironolactone group and 27 in the Placebo group) with confirmed events."||1.83|0.64|0.76
71025437|NCT00094302|141558487|SUPERIORITY_OR_OTHER||Hazard Ratio, log|1.02||||0.94|TWO_SIDED|95.0|0.69|1.5||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 103 subjects (52 in the Spironolactone group and 51 in the Placebo group) with confirmed events."||1.50|0.69|0.94
71025438|NCT00094302|141558488|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.71|1.42||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 129 subjects (65 in the Spironolactone group and 64 in the Placebo group) with confirmed events."||1.42|0.71|0.98
71108649|NCT03531814|141722583|OTHER||Spearman's correlation|-0.361||||0.306|TWO_SIDED|95.0|-0.815|0.367||The reported p-value represents the strength of the relationship between the variables for cycles 5-8.|Spearman correlation|||||0.367|-0.815|0.306
70851946|NCT00635219|141192191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.8563|TWO_SIDED|95.0|0.65|1.69||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||1.69|0.65|0.8563
70851947|NCT00635219|141192192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.86||0.1925|TWO_SIDED|95.0|-2.82|0.57||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.57|-2.82|0.1925
70851948|NCT00635219|141192192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|0.87||0.2434|TWO_SIDED|95.0|-2.72|0.69||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.69|-2.72|0.2434
70851949|NCT00635219|141192192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.86||0.7246|TWO_SIDED|95.0|-2.0|1.39||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.39|-2.00|0.7246
70851950|NCT00635219|141192192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|0.87||0.0981|TWO_SIDED|95.0|-3.16|0.27||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.27|-3.16|0.0981
70851951|NCT00635219|141192193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.2285|TWO_SIDED|95.0|-0.46|0.11||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.11|-0.46|0.2285
70851952|NCT00635219|141192193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.1794|TWO_SIDED|95.0|-0.48|0.09||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.09|-0.48|0.1794
70851953|NCT00635219|141192193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1741|TWO_SIDED|95.0|-0.48|0.09||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.09|-0.48|0.1741
70851954|NCT00635219|141192193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.15||0.2247|TWO_SIDED|95.0|-0.46|0.11||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.11|-0.46|0.2247
70851955|NCT00635219|141192194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.86||0.7789|TWO_SIDED|95.0|-1.93|1.45||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.45|-1.93|0.7789
70851956|NCT00635219|141192194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.87||0.8121|TWO_SIDED|95.0|-1.91|1.5||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.50|-1.91|0.8121
70851957|NCT00635219|141192194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.87||0.8918|TWO_SIDED|95.0|-1.82|1.59||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.59|-1.82|0.8918
70935065|NCT03737110|141370590|SUPERIORITY||Hazard Ratio (HR)|0.0||||0.0059|TWO_SIDED|95.0|0.0||Not estimable due to low number of participants with an event.|Two-sided p-value is from the log-rank test without stratification by randomization strata.|Log Rank||||||0.00|0.0059
70851958|NCT00635219|141192194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.87||0.972|TWO_SIDED|95.0|-1.69|1.75||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.75|-1.69|0.9720
70935066|NCT03737110|141370602|SUPERIORITY||Odds Ratio (OR)|0.015|||<|0.0001|TWO_SIDED|95.0|0.002|0.108||Two-sided p value calculated using a Cochran-Mantel-Haenszel test adjudicated by randomization strata.|Cochran-Mantel-Haenszel|||Participants who used ORT, corticosteroids or bailout rilonacept during the RW Period||0.108|0.002|< 0.0001
70935067|NCT03392194|141370661|OTHER|The purpose of this small pilot randomized control trial (RCT) was to assess feasibility and acceptability of conducting community based sleep hygiene and yoga interventions, to be scaled and tested in a future, larger RCT.|Mean Difference (Net)|-2.02||||0.932|TWO_SIDED|95.0|-46.35|50.39|||t-test, 2 sided|Due to main findings, analysis to explore potential mediators of effect were not pursued, despite original plan to explore explanatory variables.||Null hypothesis: There is no difference in change in sleep duration between the two intervention arms.||50.39|-46.35|0.932
70935068|NCT03068312|141370673|OTHER||Least squares mean difference|-0.66|||||TWO_SIDED|95.0|-1.1|-0.21||||||||-0.21|-1.10|
70935069|NCT02551224|141370674|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.75|||<|0.0001|TWO_SIDED|95.0|0.51|0.99|||Wilcoxon (Mann-Whitney)|||||0.99|0.51|<0.0001
71025439|NCT00094302|141558489|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.73|TWO_SIDED|95.0|0.65|1.35||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 117 subjects (57 in the Spironolactone group and 60 in the Placebo group) with confirmed events."||1.35|0.65|0.73
71025440|NCT00094302|141558490|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49|||<|0.01|TWO_SIDED|95.0|1.18|1.87||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~There were 295 subjects (175 in the Spironolactone group and 120 in the Placebo group) experiencing this endpoint. This endpoint did not undergo adjudication by the TOPCAT clinical endpoints committee."||1.87|1.18|<0.01
71025441|NCT00094302|141558491|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.75|TWO_SIDED|95.0|0.66|1.35||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|Composite endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. Component endpoints were adjudicated by the TOPCAT clinical endpoints committee. There were 58 subjects in the Spironolactone group and 61 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.||1.35|0.66|0.75
71025442|NCT00094302|141558492|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline quality of life scores as the dependent variable, and the baseline quality of life score, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.27
70851959|NCT04074161|141192217|SUPERIORITY|Responses were analysed using an analysis of covariance model with randomized treatment as factor and baseline body weight as covariate.|Treatment difference|-9.38|||<|0.0001|TWO_SIDED|95.0|-11.97|-6.8|||ANCOVA|||||-6.80|-11.97|<0.0001
71025443|NCT00094302|141558492|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||<0.01
71108650|NCT03531814|141722583|OTHER||Spearman's correlation|-0.407||||0.317|TWO_SIDED|95.0|-0.87|0.438||The reported p-value represents the strength of the relationship between the variables for cycles 9-12.|Spearman correlation|||||0.438|-0.870|0.317
70851960|NCT03890666|141192262|OTHER||Odds Ratio (OR)|1.33||||||||||||||The statistical model is a logistic regression model with treatment group as a fixed factor, pooled study sites as a random factor, and baseline ACT score as a covariate.||||
70935070|NCT02551224|141370675|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41|||<|0.0001|TWO_SIDED|95.0|0.21|0.61|||Wilcoxon (Mann-Whitney)|||||0.61|0.21|<0.0001
70935071|NCT01009645|141370686|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|ONE_SIDED|95.0||||The a priori threshold for statistical significance was p \<0.0167 as the p-value was adjusted for multiple comparisons (three planned contrasts).|Contrast Analysis|Bonferroni correction used (3 planned contrasts)||Contrast analysis was used to assess difference in vaccination status. The first contrast assessed whether or not the three newly created messages (Fact Only (FO), Fact/Myth (FM), and Fact/Myth/Refutation (FMR)) were as a group significantly different than the control message.||||<0.05
70935072|NCT01009645|141370686|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|ONE_SIDED|95.0||||The a priori threshold for statistical significance was p \<0.0167 as the p-value was adjusted for multiple comparisons (three planned contrasts).|Contrast Analysis|Bonferroni correction used (3 planned contrasts)||Contrast analysis was used to assess difference in vaccination status. The second contrast assessed whether the FO and FMR conditions were significantly different from the FM message.||||<0.05
70935073|NCT01009645|141370686|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|ONE_SIDED|95.0||||The a priori threshold for statistical significance was p \<0.0167 as the p-value was adjusted for multiple comparisons (three planned contrasts).|Contrast Analysis|Bonferroni correction used (3 planned contrasts)||Contrast analysis was used to assess difference in vaccination status. The third contrast assessed whether the FO and the FMR message conditions were significantly different.||||<0.05
70935074|NCT01009645|141370687|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||ANOVA|used Scheffe's post-hoc analysis||||||<0.05
70941704|NCT04748445|141383934|OTHER||Slope|-0.004137|STANDARD_ERROR_OF_MEAN|8.017||0.6067|TWO_SIDED|90.0|-0.01742|0.009148|||Mixed Models Analysis|||READ\_MFCC std 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.009148|-0.01742|0.6067
71108651|NCT03531814|141722583|OTHER||Spearman's correlation|-0.18||||0.67|TWO_SIDED|95.0|-0.795|0.0617||The reported p-value represents the strength of the relationship between the variables for cycles 13-18.|Spearman correlation|||||0.0617|-0.795|0.670
71108652|NCT00952705|141722619|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV-BFS was declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for the post dose A/H1N1 GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the A/H1N1 post-dose GMT ratio: (FluMist B/Yamagata A/H1N1 + FluMist B/Victoria A/H1N1) divided by Q/LAIV-BFS A/H1N1.|Ratio of geometric mean titers|0.95|||||TWO_SIDED|95.0|0.87|1.03|||Bootstrapping method|Confidence intervals calculated based on bootstrapping method.||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CIs for the ratio of A/H1N1 GMTs for the specified comparison. Geometric mean titers for the A/H1N1 influenza antigen measurements were calculated as: GMT = antilog\^y (mean \[log\^y x\]) where x was the assay result and y was the natural logarithm.||1.03|0.87|
71108653|NCT00952705|141722619|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV-BFS was declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for the post dose A/H3N2 GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the A/H3N2 post-dose GMT ratio: (FluMist B/Yamagata A/H3N2 + FluMist B/Victoria A/H3N2) divided by Q/LAIV-BFS A/H3N2.|Ratio of geometric mean titers|0.93|||||TWO_SIDED|95.0|0.85|1.0|||Bootstrapping method|Confidence intervals calculated based on bootstrapping method.||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CIs for the ratio of A/H3N2 GMTs for the specified comparison. Geometric mean titers for the A/H3N2 influenza antigen measurements were calculated as: GMT = antilog\^y (mean \[log\^y x\]) where x was the assay result and y was the natural logarithm.||1.00|0.85|
71108654|NCT00952705|141722619|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV-BFS was declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for the post dose B/Yamagata GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the B/Yamagata post-dose GMT ratio: FluMist B/Yamagata divided by Q/LAIV-BFS B/Yamagata.|Ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.79|1.02|||Bootstrapping method|Confidence intervals calculated based on bootstrapping method.||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CIs for the ratio of B/Yamagata GMTs for the specified comparison. Geometric mean titers for the B/Yamagata influenza antigen measurements were calculated as: GMT = antilog\^y (mean \[log\^y x\]) where x was the assay result and y was the natural logarithm.||1.02|0.79|
71108655|NCT00952705|141722619|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV-BFS was declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for the post dose B/Victoria GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the B/Victoria post-dose GMT ratio: FluMist B/Victoria divided by Q/LAIV-BFS B/Victoria.|Ratio of geometric mean titers|0.97|||||TWO_SIDED|95.0|0.87|1.1|||Bootstrapping method|Confidence intervals calculated based on bootstrapping method.||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CIs for the ratio of B/Victoria GMTs for the specified comparison. Geometric mean titers for the B/Victoria influenza antigen measurements were calculated as: GMT = antilog\^y (mean \[log\^y x\]) where x was the assay result and y was the natural logarithm.||1.10|0.87|
71108656|NCT05173974|141722666|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.037|TWO_SIDED|95.0|0.01|0.29||P-value included Bonferroni adjustment.|ANCOVA||ANCOVA with treatment and period as fixed effects; covariates for participant level baseline (natural logged) and period level baseline (natural logged) minus participant level baseline (natural logged). Participants included as a random effect.|||0.29|0.01|0.037
71108657|NCT05173974|141722666|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.044|TWO_SIDED|95.0|0.0|0.28||P-value included Bonferroni adjustment.|ANCOVA||ANCOVA with treatment and period as fixed effects; covariates for participant level baseline (natural logged) and period level baseline (natural logged) minus participant level baseline (natural logged). Participant included as a random effect.|||0.28|0.00|0.044
71108658|NCT05173974|141722666|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.005|TWO_SIDED|95.0|0.06|0.3||unadjusted P-value was presented.|ANCOVA||||ANCOVA with treatment and period as fixed effects; covariates for participant level baseline (natural logged) and period level baseline (natural logged) minus participant level baseline (natural logged). Participants included as a random effect.|0.30|0.06|0.005
71108659|NCT05173974|141722667|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.218|TWO_SIDED|95.0|-0.04|0.17|||ANCOVA||Statistical comparison for AOB 0-0.5|||0.17|-0.04|0.218
71108660|NCT05173974|141722667|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.034|TWO_SIDED|95.0|0.01|0.21|||ANCOVA||Statistical comparison for AOB 0-0.5|||0.21|0.01|0.034
71108661|NCT05173974|141722667|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.004|TWO_SIDED|95.0|0.05|0.25|||ANCOVA||Statistical comparison for AOB 0-0.5|||0.25|0.05|0.004
71108662|NCT05173974|141722667|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.058|TWO_SIDED|95.0|0.0|0.24|||ANCOVA||Statistical comparison for AOB 0-1|||0.24|-0.00|0.058
70851961|NCT03052426|141192283|SUPERIORITY|||||||0.9327||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSqaure 0.1394, DF 2 for aches||Wilcoxon/Kruskal-Wallis Tests and ChiSqaure analysis were completed for aches/pains at the three month time frame||||0.9327
71108663|NCT05173974|141722667|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.017|TWO_SIDED|95.0|0.03|0.27|||ANCOVA||Statistical comparison for AOB 0-1|||0.27|0.03|0.017
70851962|NCT03052426|141192283|SUPERIORITY|||||||0.7523||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSquare 0.5693, DF 2||Wilcoxon/Kruskal-Wallis Tests and ChiSqaure analysis were completed for discomfort at the three month time frame||||0.7523
71058336|NCT03104400|141621776|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.08||||0.0162|TWO_SIDED|95.0|-0.15|-0.01||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||-0.01|-0.15|0.0162
71058337|NCT03104400|141621776|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.14|||<|0.0001|TWO_SIDED|95.0|-0.2|-0.07||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||-0.07|-0.20|<0.0001
71108664|NCT05173974|141722667|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.001|TWO_SIDED|95.0|0.09|0.33|||ANCOVA||Statistical comparison for AOB 0-1|||0.33|0.09|0.001
71108665|NCT05173974|141722667|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.004|TWO_SIDED|95.0|0.06|0.3|||ANCOVA||Statistical comparison for AOB 0-3|||0.30|0.06|0.004
71108666|NCT05173974|141722667|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.01|TWO_SIDED|95.0|0.04|0.27|||ANCOVA||Statistical comparison for AOB0-3|||0.27|0.04|0.010
71108667|NCT05173974|141722667|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.002|TWO_SIDED|95.0|0.07|0.31|||ANCOVA||Statistical comparison for AOB0-3|||0.31|0.07|0.002
71108668|NCT05173974|141722667|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.022|TWO_SIDED|95.0|0.02|0.29|||ANCOVA||Statistical comparison for AOB 0-6|||0.29|0.02|0.022
71108669|NCT05173974|141722667|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.011|TWO_SIDED|95.0|0.04|0.3|||ANCOVA||Statistical comparison for AOB 0-6|||0.30|0.04|0.011
71108670|NCT05173974|141722667|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.005|TWO_SIDED|95.0|0.06|0.33|||ANCOVA||Statistical comparison for AOB 0-6|||0.33|0.06|0.005
71108671|NCT05173974|141722667|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.037|TWO_SIDED|95.0|0.01|0.27|||ANCOVA||Statistical comparison for AOB 0-9|||0.27|0.01|0.037
71108672|NCT05173974|141722667|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.013|TWO_SIDED|95.0|0.04|0.3|||ANCOVA||Statistical comparison for AOB 0-9|||0.30|0.04|0.013
71108673|NCT05173974|141722667|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.005|TWO_SIDED|95.0|0.06|0.32|||ANCOVA||Statistical comparison for AOB 0-9|||0.32|0.06|0.005
71108674|NCT02098304|141722668|SUPERIORITY_OR_OTHER||Percentage agreement|72.3|||<|0.001|TWO_SIDED|95.0|59.8|82.7|||Exact binomial test|An exact binomial test was used and an exact 95% Confidence Interval using the Clopper-Pearson method was calculated.||The null hypothesis was of chance agreement (50%) and was tested against a two-sided alternative at the 5% level of significance.||82.7|59.8|<0.001
71108675|NCT02098304|141722668|SUPERIORITY_OR_OTHER||Cohen's kappa|0.45||||0.001|TWO_SIDED|95.0|0.24|0.66|||Cohen's Kappa||Cohen's kappa is a chance-adjusted measure of agreement. A value of 0 indicates agreement by chance and 1 perfect agreement.|The null hypothesis was of chance agreement (Cohen's kappa of 0) and was tested against a two-sided alternative at the 5% level of significance. The study was powered such that 58 teeth (29 subjects), there would be 95% power to reject the null hypothesis of chance agreement (Cohen's kappa of 0) at the 5% level of significance, given that it was expected to be at least 0.4.||0.66|0.24|0.001
71108676|NCT03289143|141722672|SUPERIORITY|||||||0.6147||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.6147
70935075|NCT00768755|141370753|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.831||||0.3037|TWO_SIDED|95.0|0.508|1.36|||Log Rank|One-sided log-rank test at alpha = 0.20 significance level was used.||P-value was calculated using 1-sided log rank test, stratified by Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1) and gender (male or female). Hazard ratio (HR): the stratified Cox model was fitted, using the same stratification variables as above.||1.360|0.508|0.3037
71108677|NCT03289143|141722672|SUPERIORITY|||||||0.5778||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.5778
71108678|NCT03289143|141722672|SUPERIORITY|||||||0.5136||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.5136
71108679|NCT03289143|141722674|SUPERIORITY|||||||0.8198||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.8198
71108680|NCT03289143|141722674|SUPERIORITY|||||||0.3961||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.3961
71108681|NCT03289143|141722674|SUPERIORITY|||||||0.6043||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.6043
71108682|NCT03289143|141722675|SUPERIORITY|||||||0.0783||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.0783
71108683|NCT03289143|141722675|SUPERIORITY|||||||0.601||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.6010
71108684|NCT03289143|141722675|SUPERIORITY|||||||0.3961||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.3961
71108685|NCT03289143|141722676|SUPERIORITY|||||||0.9749||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.9749
71108686|NCT03289143|141722676|SUPERIORITY|||||||0.7718||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.7718
71108687|NCT03289143|141722676|SUPERIORITY|||||||0.5789||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.5789
71108688|NCT03289143|141722677|SUPERIORITY|||||||0.5235||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.5235
71108689|NCT03289143|141722677|SUPERIORITY|||||||0.5612||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.5612
71108690|NCT03289143|141722677|SUPERIORITY|||||||0.713||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.7130
71108691|NCT03257358|141722682|OTHER|Estimation|least squares mean|-413.4|STANDARD_ERROR_OF_MEAN|4.7|||TWO_SIDED|95.0|-422.7||||ANCOVA|||||-404.|-422.7|
71108692|NCT03257358|141722682|OTHER|Estimation|least squares mean|-0.2|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|-3.9|3.6|||ANCOVA|||||3.6|-3.9|
71108693|NCT03257358|141722683|OTHER|Estimation|least squares mean|-368.7|STANDARD_ERROR_OF_MEAN|7.08|||TWO_SIDED|95.0|-382.8|354.7|||ANCOVA|||||354.7|-382.8|
71058338|NCT03104400|141621777|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-17.1|||<|0.0001|TWO_SIDED|95.0|-19.6|-14.6||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-14.6|-19.6|<0.0001
71058339|NCT03104400|141621777|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-19.8|||<|0.0001|TWO_SIDED|95.0|-22.3|-17.3||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-17.3|-22.3|<0.0001
71058340|NCT03104400|141621778|OTHER||Response Rate Difference|24.3|||<|0.0001|TWO_SIDED|95.0|18.7|29.9||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||29.9|18.7|<0.0001
71058341|NCT03104400|141621778|OTHER||Response Rate Difference|38.5|||<|0.0001|TWO_SIDED|95.0|32.8|44.3||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||44.3|32.8|<0.0001
71058342|NCT03104400|141621779|OTHER||Response Rate Difference|13.3|||<|0.0001|TWO_SIDED|95.0|9.5|17.0||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||17.0|9.5|<0.0001
71058343|NCT03104400|141621779|OTHER||Response Rate Difference|22.9|||<|0.0001|TWO_SIDED|95.0|18.5|27.3||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||27.3|18.5|<0.0001
71058344|NCT03104400|141621780|OTHER||Response Rate Difference|16.1|||<|0.0001|TWO_SIDED|95.0|10.9|21.4||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||21.4|10.9|<0.0001
71058345|NCT03104400|141621780|OTHER||Response Rate Difference|26.2|||<|0.0001|TWO_SIDED|95.0|20.7|31.8||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||31.8|20.7|<0.0001
71058346|NCT01495702|141621806|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the Stribild group was at least 12% worse than the NNRTI+FTC/TDF group with respect to the percentage of participants maintaining HIV-1 RNA \< 50 copies/mL at Week 48. The alternative hypothesis was that the Stribild group was less than 12% worse than the NNRTI+FTC/TDF group.|Difference in proportions|5.3||||0.066|TWO_SIDED|95.0|-0.5|12.0|||Fisher Exact||The 95% confidence interval (CI) for the difference was from unconditional exact method using 2 inverted 1-sided tests with the standardized statistic using StatXact.|||12.0|-0.5|0.066
71108694|NCT03257358|141722683|OTHER|Estimation|least squares mean|-0.1|STANDARD_ERROR_OF_MEAN|3.54|||TWO_SIDED|95.0|-7.1|6.9|||ANCOVA|||||6.9|-7.1|
71108695|NCT03257358|141722684|OTHER|Estimation|least squares mean|-52.1|STANDARD_ERROR_OF_MEAN|2.58|||TWO_SIDED|95.0|-57.2|-46.9|||ANCOVA|||||-46.9|-57.2|
71108696|NCT03257358|141722684|OTHER|Estimation|least squares mean|-3.1|STANDARD_ERROR_OF_MEAN|2.27|||TWO_SIDED|95.0|-7.6|1.4|||ANCOVA|||||1.4|-7.6|
70851963|NCT03052426|141192283|SUPERIORITY|||||||0.9196||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSquare 0.1676, DF 2||Wilcoxon/Kruskal-Wallis Tests and ChiSqaure analysis were completed for interference at the three month time frame.||||0.9196
70851964|NCT03052426|141192284|SUPERIORITY|||||||0.6316||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSqaure 0.9190, DF 2||Wilcoxon/Kruskal-Wallis Tests and ChiSquare Analysis were completed||||0.6316
71025444|NCT00094302|141558493|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline quality of life scores as the dependent variable, and the baseline quality of life score, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.87
71025445|NCT00094302|141558493|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.16
71025446|NCT00094302|141558494|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline quality of life scores as the dependent variable, and the baseline quality of life score and treatment group as predictor variables. This tests whether the value of the post-baseline quality of life parameter differs by treatment group.||||0.99
71108697|NCT03257358|141722685|OTHER|Estimation|least squares mean|-43.6|STANDARD_ERROR_OF_MEAN|1.67|||TWO_SIDED|95.0|-46.9|-40.3|||ANCOVA|||||-40.3|-46.9|
71108698|NCT03257358|141722685|OTHER|Estimation|least squares mean|-0.7|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|95.0|-3.0|1.7|||ANCOVA|||||1.7|-3.0|
71108699|NCT03257358|141722686|OTHER|Estimation|least squares mean|-36.3|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|95.0|-37.2|-35.3|||ANCOVA|||||-35.3|-37.2|
71058347|NCT01644617|141621810|SUPERIORITY_OR_OTHER||Difference in Least Squares Means (LSM)|-3.62|||<|0.001|TWO_SIDED|95.0|-4.85|-2.39|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-2.39|-4.85|<0.001
70851965|NCT03052426|141192284|SUPERIORITY|||||||0.2595||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSqaure 2.6983, DF||Wilcoxon/Kruskal-Wallis Tests and ChiSqaure analysis were completed for discomfort at the six month time frame.||||0.2595
71058348|NCT01644617|141621810|SUPERIORITY_OR_OTHER||Difference in LSM|-1.98||||0.003|TWO_SIDED|95.0|-3.24|-0.72|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.72|-3.24|0.003
71058349|NCT01644617|141621811|SUPERIORITY_OR_OTHER||Difference in LSM|-2.08|||<|0.001|TWO_SIDED|95.0|-3.14|-1.03|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-1.03|-3.14|<0.001
71058350|NCT01644617|141621811|SUPERIORITY_OR_OTHER||Difference in LSM|-1.23||||0.032||95.0|-2.36|-0.11|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.11|-2.36|0.032
71058351|NCT01644617|141621812|SUPERIORITY_OR_OTHER||Difference in LSM|-1.37||||0.007|TWO_SIDED|95.0|-2.34|-0.39|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.39|-2.34|0.007
71058352|NCT01644617|141621812|SUPERIORITY_OR_OTHER||Difference in LSM|-0.54||||0.198|TWO_SIDED|95.0|-1.38|0.29|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||0.29|-1.38|0.198
71058353|NCT01644617|141621813|SUPERIORITY_OR_OTHER||Difference in LSM|-4.84|||<|0.001|TWO_SIDED|95.0|-6.59|-3.09|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-3.09|-6.59|<0.001
71058354|NCT01644617|141621813|SUPERIORITY_OR_OTHER||Difference in LSM|-2.65||||0.003|TWO_SIDED|95.0|-4.35|-0.95|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.95|-4.35|0.003
71058355|NCT01644617|141621814|SUPERIORITY_OR_OTHER||Difference in LSM|-2.62|||<|0.001|TWO_SIDED|95.0|-4.12|-1.13|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-1.13|-4.12|<0.001
71058356|NCT01644617|141621814|SUPERIORITY_OR_OTHER||Difference in LSM|-1.37||||0.091|TWO_SIDED|95.0|-2.96|0.22|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||0.22|-2.96|0.091
71058357|NCT01644617|141621815|SUPERIORITY_OR_OTHER||Difference in LSM|-1.97||||0.004|TWO_SIDED|95.0|-3.3|-0.64|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.64|-3.30|0.004
71058358|NCT01644617|141621815|SUPERIORITY_OR_OTHER||Difference in LSM|-0.83||||0.181|TWO_SIDED|95.0|-2.06|0.4|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||0.40|-2.06|0.181
71058359|NCT01644617|141621816|SUPERIORITY_OR_OTHER||Difference in LSM|-1.27|||<|0.001|TWO_SIDED|95.0|-1.92|-0.62|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.62|-1.92|<0.001
70851966|NCT03052426|141192284|SUPERIORITY|||||||0.4495||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSquare 1.5991, DF 2||Wilcoxon/Kruskal-Wallis Tests and ChiSqaure analysis were completed for interference at the six month time frame||||0.4495
70851967|NCT03052426|141192285|SUPERIORITY||||||<|0.0001||||||Aches (F-test G-G Epsilon (1.26, 15.18) = 34.70, p \< 0.0001)|MANOVA|||Three and six month results were combined and compared to baseline data for each of the outcome variables. Repeated measures MANOVAs with pairwise comparisons were used to examine the decrease of variables over time from time 1 to times 2 and 3.||||<0.0001
71058360|NCT01644617|141621816|SUPERIORITY_OR_OTHER||Difference in LSM|-0.77||||0.023|TWO_SIDED|95.0|-1.43|-0.11|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.11|-1.43|0.023
71058361|NCT01644617|141621817|SUPERIORITY_OR_OTHER||Difference in LSM|-0.53||||0.082|TWO_SIDED|95.0|-1.13|0.07|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||0.07|-1.13|0.082
71058362|NCT01644617|141621817|SUPERIORITY_OR_OTHER||Difference in LSM|-0.13||||0.691|TWO_SIDED|95.0|-0.79|0.52|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||0.52|-0.79|0.691
71058363|NCT01644617|141621818|SUPERIORITY_OR_OTHER||Difference in LSM|-0.61||||0.023|TWO_SIDED|95.0|-1.14|-0.09|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.09|-1.14|0.023
71058364|NCT01644617|141621818|SUPERIORITY_OR_OTHER||Difference in LSM|-0.34||||0.235|TWO_SIDED|95.0|-0.9|0.22|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||0.22|-0.90|0.235
71108700|NCT03257358|141722686|OTHER|Estimation|least squares mean|0.4|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-0.4|1.2|||ANCOVA|||||1.2|-0.4|
71108701|NCT03257358|141722687|OTHER|Estimation|least squares mean|-53.2|STANDARD_ERROR_OF_MEAN|0.97|||TWO_SIDED|95.0|-55.1|-51.3|||ANCOVA|||||-51.3|-55.1|
71108702|NCT03257358|141722687|OTHER|Estimation|least squares mean|0.4|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|95.0|-0.7|1.4|||ANCOVA|||||1.4|-0.7|
71108703|NCT03257358|141722688|OTHER|Estimation|least squares mean|-140.4|STANDARD_ERROR_OF_MEAN|2.71|||TWO_SIDED|95.0|-145.8|-135.0|||ANCOVA|||||-135.0|-145.8|
71108704|NCT03257358|141722688|OTHER|Estimation|least squares mean|0.7|STANDARD_ERROR_OF_MEAN|1.3|||TWO_SIDED|95.0|-1.9|3.3|||ANCOVA|||||3.3|-1.9|
71108705|NCT03257358|141722689|OTHER|Estimation|least squares mean|-85.2|STANDARD_ERROR_OF_MEAN|1.92|||TWO_SIDED|95.0|-89.0|-81.4|||ANCOVA|||||-81.4|-89.0|
71108706|NCT03257358|141722689|OTHER|Estimation|least squares mean|0.2|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|95.0|-2.3|1.9|||ANCOVA|||||1.9|-2.3|
70935076|NCT00768755|141370753|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.947||||0.3565|TWO_SIDED|95.0|0.58|1.546|||Log Rank|One-sided log-rank test at alpha = 0.20 significance level was used.||P-value was calculated using 1-sided log rank test, stratified by ECOG performance status (0 or 1) and gender (male or female). HR: the stratified Cox model was fitted, using the same stratification variables as above.||1.546|0.580|0.3565
70935077|NCT00768755|141370754|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.046||||0.5785|TWO_SIDED|95.0|0.648|1.69|||Log Rank|One-sided log-rank test at alpha = 0.20 significance level was used.||P-value was calculated using 1-sided log rank test, stratified by ECOG performance status (0 or 1) and gender (male or female). HR: the stratified Cox model was fitted, using the same stratification variables as above.||1.690|0.648|0.5785
70935078|NCT00768755|141370754|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.449||||0.9392|TWO_SIDED|95.0|0.919|2.285|||Log Rank|One-sided log-rank test at alpha = 0.20 significance level was used.||P-value was calculated using 1-sided log rank test, stratified by ECOG performance status (0 or 1) and gender (male or female). HR: the stratified Cox model was fitted, using the same stratification variables as above.||2.285|0.919|0.9392
70935079|NCT00768755|141370755|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.753||||0.0143|TWO_SIDED|95.0|1.047|2.935|||Cochran-Mantel-Haenszel|||P-value was calculated using Cochran-Mantel-Haenszel (CMH) test stratified by ECOG performance status (0 or 1) and gender (male or female).||2.935|1.047|0.0143
70935080|NCT00768755|141370755|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.512||||0.0665|TWO_SIDED|95.0|0.87|2.626|||Cochran-Mantel-Haenszel|||P-value was calculated using CMH test stratified by ECOG performance status (0 or 1) and gender (male or female).||2.626|0.870|0.0665
70935081|NCT00556478|141370838|SUPERIORITY_OR_OTHER||Ratio (over 3 months/Baseline)|3.05|||<|0.0001|TWO_SIDED|95.0|2.29|4.06|||ANCOVA|||||4.06|2.29|<0.0001
71025447|NCT00094302|141558495|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline quality of life scores as the dependent variable, and the baseline quality of life score, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.39
71025448|NCT00094302|141558495|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.01
71025449|NCT00094302|141558496|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.25|TWO_SIDED|95.0|0.85|1.04||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~There were a total of 1558 subjects (766 subjects in the Spironolactone group and 792 subjects in the Placebo) who were hospitalized for any cause while on study. This endpoint was not adjudicated by the TOPCAT clinical endpoints committee."||1.04|0.85|0.25
71025450|NCT00094302|141558497|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.27
71025451|NCT00094302|141558497|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||<0.01
71025452|NCT00094302|141558498|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.53
71025453|NCT00094302|141558498|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||<0.01
71025454|NCT00094302|141558499|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.11
71025455|NCT00094302|141558499|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||<0.01
71025456|NCT00094302|141558500|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.59
71058365|NCT01644617|141621821|SUPERIORITY_OR_OTHER||Difference in LSM: D. pteronyssinus|0.55|||<|0.001|TWO_SIDED|95.0|0.43|0.68|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.68|0.43|<0.001
71058366|NCT01644617|141621821|SUPERIORITY_OR_OTHER||Difference in LSM: D. pteronyssinus|0.42|||<|0.001|TWO_SIDED|95.0|0.33|0.52|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.52|0.33|<0.001
71058367|NCT01644617|141621821|SUPERIORITY_OR_OTHER||Difference in LSM: D. farinae|0.52|||<|0.001|TWO_SIDED|95.0|0.41|0.64|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.64|0.41|<0.001
71058368|NCT01644617|141621821|SUPERIORITY_OR_OTHER||Difference in LSM: D. farinae|0.39|||<|0.001|TWO_SIDED|95.0|0.3|0.48|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.48|0.30|<0.001
71058369|NCT01644617|141621822|SUPERIORITY_OR_OTHER||Difference in LSM: D. pteronyssinus|0.23|||<|0.001|TWO_SIDED|95.0|0.13|0.33|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.33|0.13|<0.001
71058370|NCT01644617|141621822|SUPERIORITY_OR_OTHER||Difference in LSM: D. pteronyssinus|0.19|||<|0.001|TWO_SIDED|95.0|0.12|0.25|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.25|0.12|<0.001
71058371|NCT01644617|141621822|SUPERIORITY_OR_OTHER||Difference in LSM: D. farinae|0.32|||<|0.001|TWO_SIDED|95.0|0.23|0.42|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.42|0.23|<0.001
71058372|NCT01644617|141621822|SUPERIORITY_OR_OTHER||Difference in LSM: D. farinae|0.25|||<|0.001|TWO_SIDED|95.0|0.16|0.33|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.33|0.16|<0.001
71058373|NCT01644617|141621823|SUPERIORITY_OR_OTHER||Difference in Percentage Versus Placebo|12.4||||||95.0|-3.6|28.9|||||Analysis based on the Miettinen and Nurminen method|||28.9|-3.6|
71058374|NCT01644617|141621823|SUPERIORITY_OR_OTHER||Difference in Percentage Versus Placebo|9.8|||||TWO_SIDED|95.0|-7.0|26.6|||||Analysis based on the Miettinen and Nurminen method|||26.6|-7.0|
71058375|NCT01644617|141621824|SUPERIORITY_OR_OTHER||Difference in Percentage Versus Placebo|-7.5|||||TWO_SIDED|95.0|-22.6|6.7|||||Analysis based on the Miettinen and Nurminen method|||6.7|-22.6|
71058376|NCT01644617|141621824|SUPERIORITY_OR_OTHER||Difference in Percentage Versus Placebo|-14.6|||||TWO_SIDED|95.0|-28.5|-5.4|||||Analysis based on the Miettinen and Nurminen method|||-5.4|-28.5|
71058377|NCT05246670|141621825|SUPERIORITY||Mean Difference (Final Values)|2.21|||||TWO_SIDED|95.0|-1.33|5.74||||||||5.74|-1.33|
71058378|NCT05246670|141621825|SUPERIORITY||Mean Difference (Final Values)|0.09|||||TWO_SIDED|95.0|-5.23|5.41||||||||5.41|-5.23|
71058379|NCT05246670|141621825|SUPERIORITY||Mean Difference (Final Values)|2.11|||||TWO_SIDED|95.0|-2.87|7.09||||||||7.09|-2.87|
71058380|NCT05879991|141621837|OTHER||Ratio of adjusted geometric means [%]|76.18|||||TWO_SIDED|90.0|70.21|82.65|||||Ratio \[%\] = (adjusted geometric mean zongertinib / adjusted geometric mean \[14C\]zongertinib)\*100. Intra-individual geometric coefficient of variation (gCV) \[%\] = 7.9|"Ratio of adjusted geometric means was calculated using an ANOVA model on the logarithmic scale.~The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included the effect 'subjects' as a random effect and 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale."||82.65|70.21|
71058381|NCT05879991|141621842|OTHER||Ratio of adjusted geometric means [%]|26.1|||||TWO_SIDED|90.0|22.12|30.79|||||Ratio \[%\] = (adjusted geometric mean zongertinib / adjusted geometric mean \[14C\]zongertinib)\*100. Intra-individual geometric coefficient of variation (gCV) \[%\] = 16.0|Ratio of adjusted geometric means was calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included the effect 'subjects' as a random effect and 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale.||30.79|22.12|
71108707|NCT03257358|141722690|OTHER|Estimation|least squares mean|-27.9|STANDARD_ERROR_OF_MEAN|11.65|||TWO_SIDED|95.0|-51.1|-4.8|||ANCOVA|||||-4.8|-51.1|
71058382|NCT05879991|141621843|OTHER||Ratio of adjusted geometric means [%]|76.99|||||TWO_SIDED|90.0|70.92|83.59|||||Ratio \[%\] = (adjusted geometric mean zongertinib / adjusted geometric mean \[14C\]zongertinib)\*100. Intra-individual geometric coefficient of variation (gCV) \[%\] = 7.9|Ratio of adjusted geometric means was calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included the effect 'subjects' as a random effect and 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale.||83.59|70.92|
71058383|NCT05124691|141621849|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||pairwise comparisons of cure rates within the three study groups, considering an overall significance level of 0.05. To account for multiple testing, a Bonferroni correction was applied, resulting in an adjusted significance level of 0.0167||||<0.0001
71058384|NCT05124691|141621849|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Pairwise comparisons of cure rates within the three study groups, considering an overall significance level of 0.05. To account for multiple testing, a Bonferroni correction was applied, resulting in an adjusted significance level of 0.0167||||<0.0001
71058385|NCT05124691|141621849|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Pairwise comparisons of cure rates within the three study groups, considering an overall significance level of 0.05. To account for multiple testing, a Bonferroni correction was applied, resulting in an adjusted significance level of 0.0167||||<0.0001
71058386|NCT05124691|141621852|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||Pairwise comparisons of cure rates were conducted between Albendazole and FDCx3, as well as FDCx1 and FDCx3, but not between Albendazole and FDCx1, since both contain the same dose regimen of the active drug. An overall significance level of 0.05 was considered, and to account for multiple testing, a Bonferroni correction was applied.||||<0.0001
71108708|NCT03257358|141722690|OTHER|Estimation|least squares mean|-9.4|STANDARD_ERROR_OF_MEAN|3.47|||TWO_SIDED|95.0|-16.3|-2.6|||ANCOVA|||||-2.6|-16.3|
71108709|NCT03257358|141722691|OTHER|Estimation|least squares mean|-181.2|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|95.0|-183.3|-179.0|||ANCOVA|||||-179.0|-183.3|
71108710|NCT03257358|141722691|OTHER|Estimation|least squares mean|-0.8|STANDARD_ERROR_OF_MEAN|1.66|||TWO_SIDED|95.0|-4.1|2.5|||ANCOVA|||||2.5|-4.1|
71108711|NCT03257358|141722692|OTHER|Estimation|least squares mean|-55.2|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-56.5|-53.9|||ANCOVA|||||-53.9|-56.5|
70935082|NCT00556478|141370839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|||<|0.0001|TWO_SIDED|95.0|3.61|6.34|||ANCOVA|||Analysis of IPE domain ejaculatory control||6.34|3.61|<0.0001
70935083|NCT00556478|141370839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6|||<|0.0001|TWO_SIDED|95.0|3.3|5.84|||ANCOVA|||IPE domain sexual satisfaction||5.84|3.30|<0.0001
70935084|NCT00556478|141370839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||<|0.0001|TWO_SIDED|95.0|1.86|3.2|||ANCOVA|||IPE domain distress||3.20|1.86|<0.0001
70935085|NCT05270460|141370867|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0||||Adjustment for multiple comparisons were made using Dunnett's test at the overall alpha = 0.05 significance level|ANCOVA|Fixed effects for treatment group (PCS12852 0.1 mg, PCS12852 0.5 mg, and Placebo) and type (IG or DG) and the baseline value as a continuous covariate||||||<0.05
71025457|NCT00094302|141558500|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.54
71025458|NCT00094302|141558501|SUPERIORITY_OR_OTHER|||||||0.98|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.98
71108712|NCT03257358|141722692|OTHER|Estimation|least squares mean|0.3|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-0.5|1.1|||ANCOVA|||||1.1|-0.5|
71108713|NCT03257358|141722693|OTHER|Estimation|least squares mean|-7.2|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-8.0|-6.4|||ANCOVA|||||-6.4|-8.0|
70935086|NCT05270460|141370868|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|Fixed effects for treatment group (PCS12852 0.1 mg, PCS12852 0.5 mg, and Placebo) and type (IG or DG) and the baseline value as a continuous covariate||||||<0.05
70935087|NCT05270460|141370869|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
70935088|NCT05270460|141370870|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
70935089|NCT05270460|141370871|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
70935090|NCT05270460|141370872|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
70935091|NCT05270460|141370873|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
70935092|NCT05270460|141370874|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
70935093|NCT05270460|141370875|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
70935094|NCT05270460|141370876|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
71025459|NCT00094302|141558501|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.02
71025460|NCT02780661|141558506|OTHER||Least square (LS) mean difference|-0.86||||0.0144|TWO_SIDED|95.0|-1.53|-0.196||Log10 change from baseline in aerobic bacteria microbial count as response variable, treatment and period as fixed effect, participant level and period level pre-treatment microbial count as covariates and participant as random effect.|ANCOVA||Difference is first named treatment minus second named treatment in log10{(count+1)/(baseline+1)} such that a negative difference favors the first named treatment.|H0: There is no treatment difference between daily and weekly product use. H1: There is a treatment difference between daily and weekly product use.||-0.196|-1.530|0.0144
71025461|NCT02780661|141558507|OTHER||LS mean difference|-0.48||||0.1879|TWO_SIDED|95.0|-1.23|0.261||Log10 change from baseline in anaerobic bacteria microbial count as response variable, treatment and period as fixed effect, participant level and period level pre-treatment microbial count as covariates and participant as random effect.|ANCOVA||Difference is first named treatment minus second named treatment in log10{(count+1)/(baseline+1)} such that a negative difference favors the first named treatment.|H0: There is no treatment difference between daily and weekly product use. H1: There is a treatment difference between daily and weekly product use.||0.261|-1.230|0.1879
71025462|NCT01806688|141558512|EQUIVALENCE|The study is designed to detect a 10.0% difference in area under the curve (AUC) appetite ratings between foods. The required number of Participants is 38.|||||<|0.05|||||||ANCOVA|Sources of variation included in the model: snack, visit number, baseline score, visit number × snack, and snack × overweight.||Items #1 were compared to each other and Items #2 were compared to each other||||<0.05
71108714|NCT03257358|141722693|OTHER|Estimation|least squares mean|1.1|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|95.0|0.3|2.0|||ANCOVA|||||2.0|0.3|
71108715|NCT03257358|141722694|OTHER|Estimation|least squares mean|69.4|STANDARD_ERROR_OF_MEAN|13.78|||TWO_SIDED|95.0|42.1|96.7|||ANCOVA|||||96.7|42.1|
71108716|NCT03257358|141722694|OTHER|Estimation|least squares mean|117.0|STANDARD_ERROR_OF_MEAN|10.07|||TWO_SIDED|95.0|97.1|136.9|||ANCOVA|||||136.9|97.1|
71108717|NCT03257358|141722695|OTHER|Estimation|least squares mean|-782.6|STANDARD_ERROR_OF_MEAN|138.9|||TWO_SIDED|95.0|-1058.2|-507.1|||ANCOVA|||||-507.1|-1058.2|
70935095|NCT02397707|141370896|OTHER||Geometric Least-Square Mean (GLSM)Ratio%|411.62|||||TWO_SIDED|90.0|214.72|789.08||||||An analysis of variance (ANOVA) appropriate for a parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUClast. A 90% confidence interval (CI) was constructed for the geometric least squares mean (GLSM) ratio of AUClast for the comparison groups using two 1-sided tests.||789.08|214.72|
70935096|NCT02397707|141370896|OTHER||GLSM Ratio (%)|644.15|||||TWO_SIDED|90.0|364.67|1137.82||||||An ANOVA appropriate for a parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUClast. A 90% CI was constructed for the GLSM ratio of AUClast for the comparison groups using two 1-sided tests.||1137.82|364.67|
70935097|NCT02397707|141370897|OTHER||GLSM Ratio (%)|399.24|||||TWO_SIDED|90.0|210.89|755.81||||||An ANOVA appropriate for parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUCinf. A 90% CI was constructed for the GLSM ratio of AUClast for the comparison groups using two 1-sided tests.||755.81|210.89|
71025463|NCT01806688|141558513|EQUIVALENCE|The study is designed to detect a 10.0% difference in area under the curve (AUC) appetite ratings between foods. The required number of Participants is 38.|||||<|0.05|||||||ANCOVA|Sources of variation included in the model: snack, visit number, baseline score, visit number × snack, and snack × overweight.||Items #1 were compared to each other and Items #2 were compared to each other||||<0.05
71025464|NCT01806688|141558515|EQUIVALENCE|The study is designed to detect a 10.0% difference in area under the curve (AUC) appetite ratings between foods. The required number of Participants is 38.|||||<|0.05|||||||ANCOVA|Sources of variation included in the model: snack, visit number, baseline score, visit number × snack, and snack × overweight.||Items #1 were compared to each other and Items #2 were compared to each other||||<0.05
71025465|NCT00006170|141558521|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.001|TWO_SIDED|95.0|||||Regression, Logistic|||||||0.001
71025466|NCT00006170|141558521|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.25||95.0|||||Regression, Logistic|||||||0.25
71025467|NCT00006170|141558521|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.07||95.0|||||Regression, Logistic|||||||0.07
71025468|NCT00006170|141558522|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.|||||<|0.001||95.0|||||Regression, Logistic|||||||<0.001
71025469|NCT00006170|141558522|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.053||95.0|||||Regression, Logistic|||||||0.053
71025470|NCT00006170|141558522|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.08||95.0|||||Regression, Logistic|||||||0.08
71025471|NCT00006170|141558523|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.006||95.0|||||Regression, Logistic|||||||0.006
71025472|NCT00006170|141558523|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.45||95.0|||||Regression, Logistic|||||||0.45
71025473|NCT00006170|141558523|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.046||95.0|||||Regression, Logistic|||||||0.046
71108718|NCT03257358|141722695|OTHER|Estimation|least squares mean|-485.9|STANDARD_ERROR_OF_MEAN|91.88|||TWO_SIDED|95.0|-667.3|-304.4|||ANCOVA|||||-304.4|-667.3|
70935098|NCT02397707|141370897|OTHER||GLSM Ratio (%)|599.63|||||TWO_SIDED|90.0|342.36|1050.22||||||An ANOVA appropriate for parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUCinf. A 90% CI was constructed for the GLSM ratio of AUCinf for the comparison groups using two 1-sided tests.||1050.22|342.36|
70935099|NCT02397707|141370898|OTHER||GLSM Ratio (%)|338.41|||||TWO_SIDED|90.0|168.96|677.79||||||An ANOVA appropriate was fitted to the natural logarithmic transformation of voxilaprevir Cmax. A 90% CI was constructed for the GLSM ratio of AUClast for the comparison groups using two 1-sided tests.||677.79|168.96|
71025474|NCT02058628|141558533|SUPERIORITY_OR_OTHER|||||||0.0004||95.0||||Data is represented as per CTR.|Wilcoxon (Mann-Whitney)|DUAC versus SKINOREN with a nominal alpha level of 5%, without adjustment for multiple comparisons.||||||0.0004
71025475|NCT01767597|141558546|SUPERIORITY_OR_OTHER|||||||0.5||||||No p-value adjustments for multiple comparisons were required. Significance was determined using a p-value \<0.05.|Chi-squared|||Power calculations were performed to detect \>15% difference in immediate linkage-to-care and vaccination. We hypothesized from discussions with an expert panel that \~30% of participants would have appropriate care with standard HBV serology. Assuming type 1 error=0.05 and power=80%, 152 participants per arm would be needed. As \~40% of the population would be nonimmunized or HBsAg-positive from previous data, a minimum 375 participants per arm would be required.||||0.5
71025476|NCT04527471|141558552|OTHER|||||||1|TWO_SIDED|95.0|||||Fisher Exact|||||||1
71025477|NCT00096265|141558557|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.43||||0.93|TWO_SIDED|95.0|0.89|2.31||One-sided|Log Rank||WBRT + SRS is the denominator of the hazard ratio.|120 patients per arm required to detect a 33% reduction in hazard rate corresponding to improvement in MST of 5.9 (null hypothesis) to 8.9 months with a one-sided type I error rate of 0.025 and 85% power.||2.31|0.89|0.93
71025478|NCT00096265|141558557|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.47||||0.95|TWO_SIDED|95.0|0.92|2.36||One-sided|Log Rank||WBRT + SRS is the denominator of the hazard ratio.|120 patients per arm required to detect a 33% reduction in hazard rate corresponding to improvement in MST of 5.9 (null hypothesis) to 8.9 months with a one-sided type I error rate of 0.025 and 85% power.||2.36|0.92|0.95
71025479|NCT00096265|141558558|SUPERIORITY|||||||0.3|||||||Gray's test|||||||0.30
71025480|NCT00096265|141558558|SUPERIORITY|||||||0.48|||||||Gray's test|||||||0.48
71025481|NCT00096265|141558560|SUPERIORITY|||||||0.39|||||||Chi-squared|||With 70 patients per arm, a 0.05 level chi-square test would have 80% power to distinguish between two groups when the proportions in the three categories are as follows for standard vs. experimental arm, respectively: 25% vs. 50% improvement, 55% vs. 40% stable, and 20% vs. 10% deterioration, or any distribution that corresponds to an effect size, Δ² = Σ(π2j-π1j)2/\[2(π2j-π1j)\], of 0.0702.||||0.39
71025482|NCT00096265|141558560|SUPERIORITY|||||||0.28|||||||Chi-squared|||With 70 patients per arm, a 0.05 level chi-square test would have 80% power to distinguish between two groups when the proportions in the three categories are as follows for standard vs. experimental arm, respectively: 25% vs. 50% improvement, 55% vs. 40% stable, and 20% vs. 10% deterioration, or any distribution that corresponds to an effect size, Δ² = Σ(π2j-π1j)2/\[2(π2j-π1j)\], of 0.0702.||||0.28
71108719|NCT03257358|141722696|OTHER|Estimation|least squares mean|-33.3|STANDARD_ERROR_OF_MEAN|7.47|||TWO_SIDED|95.0|-48.2|-18.5|||ANCOVA|||||-18.5|-48.2|
70935100|NCT02397707|141370898|OTHER||GLSM Ratio (%)|713.92|||||TWO_SIDED|90.0|384.07|1327.06||||||An ANOVA appropriate was fitted to the natural logarithmic transformation of voxilaprevir Cmax. A 90% CI was constructed for the GLSM ratio of AUClast for the comparison groups using two 1-sided tests.||1327.06|384.07|
70941705|NCT04748445|141383934|OTHER||Slope|0.000376|STANDARD_ERROR_OF_MEAN|7.531||0.9603|TWO_SIDED|90.0|-0.0121|0.01286|||Mixed Models Analysis|||READ\_MFCC std 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.01286|-0.01210|0.9603
70941706|NCT04748445|141383934|OTHER||Slope|-0.002185|STANDARD_ERROR_OF_MEAN|5.703||0.7022|TWO_SIDED|90.0|-0.01164|0.007265|||Mixed Models Analysis|||READ\_MFCC std 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.007265|-0.01164|0.7022
71025483|NCT00096265|141558561|SUPERIORITY|||||||0.002|||||||Chi-squared|||108 with three month performance status data, per arm, would result in a 0.050 level chi-square test with 90% power to distinguish between the groups when the proportions in the 3 categories are characterized by an effect size, Δ² = Σ(π2j-π1j)2/\[2(π2j-π1j)\], of 0.0586.||||0.002
71108720|NCT03257358|141722696|OTHER|Estimation|least squares mean|-25.8|STANDARD_ERROR_OF_MEAN|5.52|||TWO_SIDED|95.0|-36.7|-14.9|||ANCOVA|||||-14.9|-36.7|
71025484|NCT00096265|141558561|SUPERIORITY||||||<|0.001|||||||Chi-squared|||108 cases with three month performance status data, per arm, would result in a 0.050 level chi-square test with 90% power to distinguish between the groups when the proportions in the 3 categories are characterized by an effect size, Δ² = Σ(π2j-π1j)2/\[2(π2j-π1j)\], of 0.0586.||||< 0.001
71025485|NCT00096265|141558562|SUPERIORITY|Assuming the survival rate of the standard arm (MST = 5.9 months), then 49% of patients were expected to be alive at six months. Assuming steroid data would be available for 90% of these patients, results in a projection of 52 cases/arm with steroid data at 6 months. With this sample size, a two-sided 0.050 alpha test will have 90% power to distinguish between the groups when the proportions in the 3 categories are characterized by an effect size, Δ² = Σ(π2j-π1j)2/\[2(π2j-π1j)\], of 0.1217.||||||0.51|||||||Chi-squared|||||||0.51
71025486|NCT00096265|141558562|SUPERIORITY|||||||0.56|||||||Chi-squared|||Assuming the survival rate of the standard arm (MST = 5.9 months), then 49% of patients were expected to be alive at six months. Assuming steroid data would be available for 90% of these patients, results in a projection of 52 cases/arm with steroid data at 6 months. With this sample size, a two-sided 0.050 alpha test will have 90% power to distinguish between the groups when the proportions in the 3 categories are characterized by an effect size, Δ² = Σ(π2j-π1j)2/\[2(π2j-π1j)\], of 0.1217.||||0.56
71025487|NCT00096265|141558563|SUPERIORITY|||||||0.78|||||||Chi-squared|||A two group chi-square test with a 0.05 two-sided significance level would have 89% power to detect the difference between a proportion of 0.50 and a proportion of 0.30, or equivalently, of 0.70, when the sample size in each group is 120.||||0.78
71025488|NCT00096265|141558563|SUPERIORITY|||||||0.8|||||||Chi-squared|||A two group chi-square test with a 0.05 two-sided significance level would have 89% power to detect the difference between a proportion of 0.50 and a proportion of 0.30, or equivalently, of 0.70, when the sample size in each group is 120.||||0.80
71025489|NCT01506323|141558564|SUPERIORITY_OR_OTHER||||||<|0.006|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|Mixed-effects, repeated measures models adjusting for demographic factors were implemented.||This analysis is from baseline (week 0) to post-treatment (week 8). Cronbach's alpha for this study was .92 at baseline.||||<.006
71025490|NCT01506323|141558564|SUPERIORITY_OR_OTHER||repeated measures||||<|0.031|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using false discovery rate.|Mixed Models Analysis|This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.||This analysis is from baseline (week 0) to 2 months follow-up.||||<.031
71025491|NCT01506323|141558565|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED|||||The p-value is based on false discovery rate adjustment for multiple comparisons.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .86 at baseline.||||0.82
71025492|NCT01506323|141558565|SUPERIORITY_OR_OTHER|||||||0.82|ONE_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2 months post-treatment.||||0.82
71025493|NCT01506323|141558566|SUPERIORITY_OR_OTHER||||||<|0.008|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|repeated measures|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .85 at baseline.||||<0.008
71025494|NCT01506323|141558566|SUPERIORITY_OR_OTHER||||||<|0.09|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2 months post-treatment||||<0.09
71108721|NCT03257358|141722697|OTHER|Estimation|least squares mean|-888.7|STANDARD_ERROR_OF_MEAN|13.1|||TWO_SIDED|95.0|-914.6|-862.7|||ANCOVA|||||-862.7|-914.6|
71108722|NCT03257358|141722697|OTHER|Estimation|least squares mean|-3.3|STANDARD_ERROR_OF_MEAN|7.24|||TWO_SIDED|95.0|-17.6|11.0|||ANCOVA|||||11.0|-17.6|
71108723|NCT03257358|141722698|OTHER|Estimation|least squares mean|-39.5|STANDARD_ERROR_OF_MEAN|1.053|||TWO_SIDED|95.0|-41.59|-37.42|||ANCOVA|||||-37.42|-41.59|
71108724|NCT03257358|141722698|OTHER|Estimation|least squares mean|0.14|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|95.0|-0.87|1.14|||ANCOVA|||||1.14|-0.87|
71108725|NCT03257358|141722699|OTHER|Estimation|least squares mean|-248.9|STANDARD_ERROR_OF_MEAN|15.0|||TWO_SIDED|95.0|-278.7|-219.2|||ANCOVA|||||-219.2|-278.7|
71108726|NCT03257358|141722699|OTHER|Estimation|least squares mean|-9.9|STANDARD_ERROR_OF_MEAN|7.71|||TWO_SIDED|95.0|-25.1|5.4|||ANCOVA|||||5.4|-25.1|
71108727|NCT03257358|141722700|OTHER|Estimation|least squares mean|5.6|STANDARD_ERROR_OF_MEAN|1.249|||TWO_SIDED|95.0|3.13|8.08|||ANCOVA|||||8.08|3.13|
71108728|NCT03257358|141722700|OTHER|Estimation|least squares mean|0.04|STANDARD_ERROR_OF_MEAN|0.364|||TWO_SIDED|95.0|-0.68|0.76|||ANCOVA|||||0.76|-0.68|
71108729|NCT03257358|141722701|OTHER|Estimation|least squares mean|-231.0|STANDARD_ERROR_OF_MEAN|1.75|||TWO_SIDED|95.0|-234.5|-227.6|||ANCOVA|||||-227.6|-234.5|
71108730|NCT03257358|141722701|OTHER|Estimation|least squares mean|-0.3|STANDARD_ERROR_OF_MEAN|2.45|||TWO_SIDED|95.0|-5.2|4.5|||ANCOVA|||||4.5|-5.2|
71108731|NCT03257358|141722702|OTHER|Estimation|least squares mean|-8.3|STANDARD_ERROR_OF_MEAN|0.455|||TWO_SIDED|95.0|-9.21|-7.4|||ANCOVA|||||-7.40|-9.21|
71108732|NCT03257358|141722702|OTHER|Estimation|least squares mean|0.32|STANDARD_ERROR_OF_MEAN|0.251|||TWO_SIDED|95.0|-0.17|0.82|||ANCOVA|||||0.82|-0.17|
70935101|NCT02157948|141370907|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Testing: The lower bound of the 2-sided 95% CI of the between-group difference (denosumab CP4 - denosumab CP2) in percent change from baseline in lumbar spine BMD at 12 months was compared with the non-inferiority margin of -1.44% for assessing non-inferiority.|Difference from CP2|-0.07|||<|0.001|TWO_SIDED|95.0|-0.72|0.57||One-sided p-value based on the prespecified non-inferiority margin of -1.44% for lumbar spine.|ANCOVA|||The treatment comparison was analyzed using the analysis of covariance (ANCOVA) model including treatment, baseline BMD value, machine type, and machine type-by-baseline BMD value interaction. The effect of denosumab CP4 on lumbar spine BMD at 12 months relative to the effect of denosumab CP2 was estimated by the least-squares mean of the treatment difference (denosumab CP4 - denosumab CP2) and the corresponding 2-sided 95% confidence interval (CI).||0.57|-0.72|< 0.001
70935102|NCT02157948|141370907|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence Testing: The lower and upper bounds of the same 2-sided 95% CI of the between-group difference were compared with the equivalence margin of ±1.44% for assessing equivalence.|Difference from CP2|-0.07|||<|0.001|TWO_SIDED|95.0|-0.72|0.57||Two-sided p-value based on the prespecified equivalence margin of ±1.44% for lumbar spine.|ANCOVA|||The treatment comparison was analyzed using the analysis of covariance (ANCOVA) model including treatment, baseline BMD value, machine type, and machine type-by-baseline BMD value interaction. The effect of denosumab CP4 on lumbar spine BMD at 12 months relative to the effect of denosumab CP2 was estimated by the least-squares mean of the treatment difference (denosumab CP4 - denosumab CP2) and the corresponding 2-sided 95% confidence interval (CI).||0.57|-0.72|< 0.001
71058387|NCT05124691|141621852|SUPERIORITY||||||=|0.0007|||||||Cochran-Mantel-Haenszel|||Pairwise comparisons of cure rates were conducted between Albendazole and FDCx3, as well as FDCx1 and FDCx3, but not between Albendazole and FDCx1, since both contain the same dose regimen of the active drug. An overall significance level of 0.05 was considered, and to account for multiple testing, a Bonferroni correction was applied.||||=0.0007
71058388|NCT05124691|141621855|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||< 0.001
71058389|NCT05124691|141621855|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71058390|NCT05124691|141621855|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71058391|NCT04345913|141621994|OTHER|This test is used to compare the survival distributions of different groups in a survival analysis. It's a nonparametric test.||||||0.5259|||||||Log Rank|||||||0.5259
71058392|NCT04345913|141621999|OTHER|This test is used to compare the survival distributions of different groups in a survival analysis. It's a nonparametric test.||||||0.706|||||||Log Rank|||||||0.7060
71058393|NCT02503787|141622032|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||A negative value for change in pain represents a reduction (improvement) of the subject's pain score. The null hypothesis was that the mean change from baseline to 3 months equals 0. The sample provided over 90% power, with two-sided significance level of 0.05, to detect a change of 2 points.||||<0.01
70851968|NCT03052426|141192285|SUPERIORITY||||||=|0.0006||||||Uncomfortable (F-test G-G Epsilon (1.43, 17.15) = 14.39, p = 0.0006), from time 1 to times 2 and 3|MANOVA|||Three and six month results were combined and compared to baseline data for each of the outcome variables. Repeated measures MANOVAs with pairwise comparisons were used to examine the decrease of variables over time from time 1 to times 2 and 3.||||=0.0006
70851969|NCT03052426|141192285|SUPERIORITY||||||<|0.0001||||||Interference (F-test G-G Epsilon (1.55, 18.66) = 34.09, p \< 0.0001), from time 1 to times 2 and 3.|MANOVA|||We used repeated measures MANOVAs with pairwise comparisons to examine the decrease of the variables over time. Significant differences for within subjects by time were found||||<0.0001
70851970|NCT03083990|141192289|EQUIVALENCE|Geometric mean ratio and its 90%CI are obtained after anti-logarithmic transformation.If 90% CI for the geometric mean ratio of AUC 0-t and AUC 0-∞ (trial/control) ranges between 0.8-1.25, then it is considered that IBI305 and Bevacizumab are bioequivalent.|Odds Ratio (OR)|0.9502|||>|0.05|TWO_SIDED|90.0|0.8921|1.012|||ANOVA|||||1.0120|0.8921|>0.05
70851971|NCT03083990|141192290|EQUIVALENCE|Geometric mean ratio and its 90%CI are obtained after anti-logarithmic transformation.If 90% CI for the geometric mean ratio of AUC 0-t and AUC 0-∞ (trial/control) ranges between 0.8-1.25, then it is considered that IBI305 and Bevacizumab are bioequivalent.|Odds Ratio (OR)|0.9483|||>|0.05|TWO_SIDED|90.0|0.8896|1.0108|||ANOVA|||||1.0108|0.8896|>0.05
70851972|NCT03083990|141192291|EQUIVALENCE||Odds Ratio (OR)|0.9749|||>|0.05|TWO_SIDED|90.0|0.9123|1.0418|||ANOVA|||||1.0418|0.9123|>0.05
70851973|NCT00146848|141192309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|1.75||0.86|TWO_SIDED|95.0|-3.14|3.74|||t-test, 2 sided|||The changes in quality of life were compared between groups using two-sided t-tests.||3.74|-3.14|0.86
70851974|NCT00146848|141192309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.49|STANDARD_ERROR_OF_MEAN|1.87||0.43|TWO_SIDED|95.0|-2.18|5.16|||t-test, 2 sided|||The difference in changes in quality of life between groups were compared using a t-test.||5.16|-2.18|0.43
70851975|NCT00146848|141192310|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Cochran-Armitage test for trend|||One sided test testing for shift towards improvement in either atrial support pacing treatment arm compared to the DDD-40 arm.||||0.55
70851976|NCT00146848|141192310|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Cochran-Armitage test for trend|||||||0.80
70851977|NCT00146848|141192311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.17|STANDARD_ERROR_OF_MEAN|6.35||0.11|TWO_SIDED|95.0|-22.65|2.3|||t-test, 2 sided|||Compare the difference in the changes in physical activity scores between groups using a t-test.||2.30|-22.65|0.11
70851978|NCT00146848|141192311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.24|STANDARD_ERROR_OF_MEAN|6.55||0.04|TWO_SIDED|95.0|-26.11|-0.37|||t-test, 2 sided|||"Compare the difference in the changes in physical activity scores between groups using a t-test.~To adjust for multiple comparisons, an alpha level of 0.025 should be used to deem significance."||-0.37|-26.11|0.04
70851979|NCT01798849|141192314|OTHER||Difference in Least-square (LS) Means|-0.5||||0.732|TWO_SIDED|95.0|-3.42|2.43|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||2.43|-3.42|0.732
70851980|NCT01798849|141192314|OTHER||Difference in LS means|-0.94||||0.531|TWO_SIDED|95.0|-3.94|2.06|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||2.06|-3.94|0.531
70851981|NCT01798849|141192314|OTHER||Difference in LS Means|-2.88||||0.056|TWO_SIDED|95.0|-5.83|0.08|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.08|-5.83|0.056
70851982|NCT01798849|141192314|OTHER||Difference in LS means|-2.92||||0.063|TWO_SIDED|95.0|-6.0|0.17|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.17|-6.00|0.063
71025495|NCT01506323|141558567|SUPERIORITY_OR_OTHER||||||<|0.006|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .78 at baseline.||||<.006
71025496|NCT01506323|141558567|SUPERIORITY_OR_OTHER||||||<|0.03|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|repeated measures|||This analysis is from baseline to 2 months post-treatment.||||<.03
71025497|NCT01506323|141558568|SUPERIORITY_OR_OTHER||||||<|0.0008|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|repeated measures|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .89 at baseline.||||<0.0008
71058394|NCT06360081|141622060|EQUIVALENCE|The assessment of bioequivalence was based on two-sided 90% CIs for the ratios of the geometric means (gMean) (T/R) using an acceptance range of 80.0 to 125.0%.|Ratio of adjusted geometric means (T/R)|99.89|||<|0.0001|TWO_SIDED|90.0|97.08|102.78||p-value was calculated for ratios outside the 80.0 to 125.0% interval.|ANOVA||Ratio as percentage \[%\] Intra-individual geometric coefficient of variation (gCV) = 9.0%.|PK endpoints were back transformed to the original scale to provide the point estimate and 90% confidence intervals (CIs) for each endpoint. The model included effects accounting for variation in sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the others were considered as fixed. Confidence intervals were calculated based on the residual error from the ANOVA.||102.78|97.08|<0.0001
71108733|NCT00730756|141722730|SUPERIORITY_OR_OTHER|||||||0.845||95.0|||||ANCOVA|Center, baseline eosinophils, baseline symptom score, age, and gender were included as covariates in all efficacy analyses.||||||0.845
71108734|NCT01152307|141722742|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.42|STANDARD_DEVIATION|1.6||0.01|TWO_SIDED|95.0|0.76|6.09|||t-test, 2 sided|||We tested for a difference in the mean total knowledge score between the decision aid and control groups using independent t-test (2 sided). With 100 patients in each arm, the study had more than 90% power to detect a 10% difference in knowledge assuming a common standard deviation of 18%.||6.09|0.76|0.01
71108735|NCT01126190|141722744|NON_INFERIORITY|Non-inferiority was demonstrated if the upper endpoint of the CI for the difference in mean DSN was less than or equal to 0.62 days|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.13|0.37||||||For the primary non-inferiority endpoint of cycle 1 DSN, the 95% confidence interval (CI) for difference in DSN was calculated by stratified bootstrap resampling.||0.37|-0.13|
70851983|NCT01798849|141192314|OTHER||Difference in LS means|-4.89||||0.002|TWO_SIDED|95.0|-7.79|-1.99|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-1.99|-7.79|0.002
70851984|NCT01798849|141192314|OTHER||Difference in LS means|-5.31||||0.001|TWO_SIDED|95.0|-8.32|-2.31|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-2.31|-8.32|0.001
70851985|NCT01798849|141192314|OTHER||Difference in LS means|-5.61||||0.001|TWO_SIDED|95.0|-8.62|-2.6|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-2.60|-8.62|0.001
70851986|NCT01798849|141192314|OTHER||Difference in LS means|-7.56|||<|0.0001|TWO_SIDED|95.0|-10.5|-4.63|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-4.63|-10.50|<0.0001
70851987|NCT01798849|141192317|OTHER||Difference in LS means|-2.34||||0.165|TWO_SIDED|95.0|-5.7|1.02|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||1.02|-5.70|0.165
70851988|NCT01798849|141192317|OTHER||Difference in LS means|-3.53||||0.038|TWO_SIDED|95.0|-6.86|-0.21|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-0.21|-6.86|0.038
70935103|NCT01604824|141370910|SUPERIORITY||LS Mean Difference|-53.72|STANDARD_ERROR_OF_MEAN|11.486|=|0.0009|TWO_SIDED|95.0|-79.31|-28.12||Threshold for significance ≤ 0.05|ANCOVA|||||-28.12|-79.31|= 0.0009
70935104|NCT01604824|141370910|SUPERIORITY||LS Mean Difference|-43.28|STANDARD_ERROR_OF_MEAN|10.965|=|0.0056|TWO_SIDED|95.0|-69.21|17.35||Threshold for significance ≤ 0.05|ANCOVA|||||17.35|-69.21|= 0.0056
71025498|NCT01506323|141558568|SUPERIORITY_OR_OTHER||||||<|0.006|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Wilcoxon (Mann-Whitney)|||This analysis is from baseline to 2 months post-treatment.||||<0.006
71025499|NCT01506323|141558569|SUPERIORITY_OR_OTHER||||||<|0.1|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing. Raw p-value was \<0.02.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for total score in this study was .86 at baseline.||||<0.10
71025500|NCT01506323|141558569|SUPERIORITY_OR_OTHER||||||<|0.49|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment.||||<0.49
71025501|NCT01506323|141558570|SUPERIORITY_OR_OTHER||||||<|0.78|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .96 at baseline.||||<0.78
71025502|NCT01506323|141558570|SUPERIORITY_OR_OTHER||||||<|0.99|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2-months post-treatment.||||<0.99
71025503|NCT01506323|141558571|SUPERIORITY_OR_OTHER||||||<|0.04|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis was from baseline to post-treatment. Cronbach's alpha for this study was .92 at baseline.||||<0.04
71108736|NCT00524121|141722751|SUPERIORITY_OR_OTHER|||||||0.011|||||||Wilcoxon signed rank test|||||||0.011
71108737|NCT00524121|141722752|SUPERIORITY_OR_OTHER|||||||0.115||95.0|||||Log Rank|||||||0.115
71108738|NCT00524121|141722753|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
71108739|NCT00524121|141722754|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
71108740|NCT00524121|141722755|SUPERIORITY_OR_OTHER|||||||0.5467|||||||Fisher Exact|||||||0.5467
71108741|NCT01114737|141722756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|2.3||0.085|TWO_SIDED|95.0|-8.9|0.6|||ANCOVA|Adjusted for baseline ADHD-RS/ASRS total score, age group, and ADHD medication.||||0.6|-8.9|0.085
71108742|NCT01114737|141722757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.9||0.669|TWO_SIDED|95.0|-1.5|2.3|||ANCOVA|Adjusted for baseline HAMA Anxiety Scale Total Score, age group, ADHD symptom, and ADHD medication.||||2.3|-1.5|0.669
71108743|NCT01114737|141722758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.8||0.588|TWO_SIDED|95.0|-1.1|1.9|||ANCOVA|Adjusted for Baseline HAM-D Rating Scale Total Score, age group, ADHD symptom, and ADHD medication.||||1.9|-1.1|0.588
71025504|NCT01506323|141558571|SUPERIORITY_OR_OTHER||||||<|0.25|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2-months post-treatment.||||<0.25
71025505|NCT01506323|141558572|SUPERIORITY_OR_OTHER||||||<|0.99|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .89 at baseline.||||<0.99
70851989|NCT01798849|141192317|OTHER||Difference in LS means|-6.32||||0|TWO_SIDED|95.0|-9.55|-3.1|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-3.10|-9.55|0.000
70935105|NCT01604824|141370911|SUPERIORITY||LS Mean Difference|-49.55|STANDARD_ERROR_OF_MEAN|12.05|=|0.0021|TWO_SIDED|95.0|-76.39|-22.7||Threshold for significance ≤ 0.05|ANCOVA|||LS means (SE), mean difference, 95% CI, and p-values were derived from ANCOVA with treatment group as factor and baseline as covariate.||-22.7|-76.39|= 0.0021
71025506|NCT01506323|141558572|SUPERIORITY_OR_OTHER||||||<|0.94|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2-months post-treatment.||||<0.94
71108744|NCT01114737|141722759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.531|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|Adjusted for baseline CGI-Severity Response, age group, ADHD symptom, and ADHD medication.||||0.2|-0.4|0.531
71108745|NCT01114737|141722760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|2.2||0.661|TWO_SIDED|95.0|-5.5|3.6|||ANCOVA|Adjusted for Baseline BRIEF Adult-GEC T Score, ADHD symptom, and ADHD medication.||||3.6|-5.5|0.661
71108746|NCT01114737|141722761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|1.9||0.034|TWO_SIDED|95.0|-7.9|-0.3|||ANCOVA|Adjusted for Baseline BRIEF Parent-GEC T Score, ADHD symptom, and ADHD medication.||||-0.3|-7.9|0.034
71108747|NCT01114737|141722762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|2.6||0.312|TWO_SIDED|95.0|-2.6|7.8|||ANCOVA|Adjusted for Week 13 ADHD RS/ASRS Total Score, age group, and ADHD medication.||||7.8|-2.6|0.312
71025507|NCT01506323|141558573|SUPERIORITY_OR_OTHER||||||<|0.12|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .88 at baseline.||||<0.12
71025508|NCT01506323|141558573|SUPERIORITY_OR_OTHER||||||<|0.49|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2-months post-treatment.||||<0.49
71025509|NCT01506323|141558574|SUPERIORITY_OR_OTHER||||||<|0.59|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for total score was .89 at baseline.||||<0.59
71025510|NCT01506323|141558574|SUPERIORITY_OR_OTHER||||||<|0.1|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|Mixed-effects, repeated measures models adjusting for demographic factors were implemented.||This analysis is from baseline to 2-months post-treatment.||||<0.10
71108748|NCT01114737|141722763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|1.0||0.59|TWO_SIDED|95.0|-2.4|1.4|||ANCOVA|Adjusted for Week 13 HAMA Anxiety Rating Scale Total Score, age group, ADHD symptom, and ADHD medication.||||1.4|-2.4|0.590
71108749|NCT01114737|141722764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.8||0.636|TWO_SIDED|95.0|-1.2|1.9|||ANCOVA|Adjusted for Week 13 HAMD Rating Scale Total Score, age group, ADHD symptom, and ADHD||||1.9|-1.2|0.636
71108750|NCT01114737|141722765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.51|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|Adjusted for Week 13 Global Impression-Severity Score, ADHD symptom, and ADHD medication.||||0.5|-0.2|0.510
71108751|NCT01114737|141722766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|1.8||0.395|TWO_SIDED|95.0|-2.1|5.2|||ANCOVA|Adjusted for Week 13 BRIEF Adult-GEC T Score, ADHD symptom, and ADHD medication.||||5.2|-2.1|0.395
71108752|NCT01114737|141722767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|1.7||0.443|TWO_SIDED|95.0|-2.1|4.7|||ANCOVA|Adjusted for Week 13 BRIEF Parent-GEC T Score, ADHD symptom, and ADHD medication.||||4.7|-2.1|0.443
71108753|NCT01114737|141722768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|2.8||0.953|TWO_SIDED|95.0|-5.5|5.8|||ANCOVA|Adjusted for Baseline ADHD-RS/ASRS Total Score, ADHD symptom, and ADHD medication.||||5.8|-5.5|0.953
71108754|NCT01114737|141722769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.0||0.733|TWO_SIDED|95.0|-2.4|1.7|||ANCOVA|Adjusted for Baseline Hamilton Anxiety Rating Scale (HAM-A) Score, ADHD symptom, and ADHD medication.||||1.7|-2.4|0.733
71058395|NCT06360081|141622061|EQUIVALENCE|The assessment of bioequivalence was based on two-sided 90% CIs for the ratios of the geometric means (gMean) (T/R) using an acceptance range of 80.0 to 125.0%.|Ratio of adjusted geometric means (T/R)|100.83|||<|0.0001|TWO_SIDED|90.0|96.43|105.44||p-value was calculated for ratios outside the 80.0 to 125.0% interval.|ANOVA||Ratio as percentage \[%\] Intra-individual geometric coefficient of variation (gCV) = 14.2%.|PK endpoints were back transformed to the original scale to provide the point estimate and 90% confidence intervals (CIs) for each endpoint. The model included effects accounting for variation in sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the others were considered as fixed. Confidence intervals were calculated based on the residual error from the ANOVA.||105.44|96.43|<0.0001
71058396|NCT04140032|141622063|SUPERIORITY||Difference between groups in change in B|-0.18|STANDARD_DEVIATION|0.06||0.003|TWO_SIDED|95.0|-0.31|-0.06|||Mixed Models Analysis|p \< 0.05 considered significant||||-0.06|-0.31|0.003
71058397|NCT04140032|141622064|SUPERIORITY||Odds ratio for difference between groups|1.29||||0.7|TWO_SIDED|95.0|0.034|4.91|||Mixed Models Analysis|p \< 0.05 considered significant|Reported dispersion parameter is standard error of log(OR)|||4.91|.034|0.7
71058398|NCT04140032|141622065|SUPERIORITY||Difference between groups in change in f|-0.2|STANDARD_DEVIATION|0.19||0.3|TWO_SIDED|95.0|-0.58|0.17|||Mixed Models Analysis|||||0.17|-0.58|0.3
71058399|NCT04140032|141622069|SUPERIORITY||Odds ratio for difference between groups|1.1|STANDARD_ERROR_OF_MEAN|0.35||0.8|TWO_SIDED|95.0|0.56|2.16|||Mixed Models Analysis|p \< 0.05 considered significant|Reported dispersion parameter is standard error of log(OR)|||2.16|0.56|0.8
71058400|NCT04140032|141622069|SUPERIORITY||Odds ratio for difference between groups|1.1||||0.8|TWO_SIDED|95.0|0.56|2.16|||Mixed Models Analysis|p \< 0.05 considered significant|Reported dispersion parameter is standard error of log(OR)|||2.16|0.56|0.8
71058401|NCT00588770|141622070|SUPERIORITY|||||||0.22||||||The P value was based on stratified log rank test, stratified by choice of chemotherapy combination, performance status, weight loss in the last 6 months, and prior radiation of the head and neck.|Log Rank|||The study hypothesis is that the addition of bevacizumab will improve the median survival by 35% from 8.5 months (based on E1395 and E5397) to 11.5 months.||||0.22
71058402|NCT03698019|141622075|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.004|TWO_SIDED||||||Log Rank|||||||0.004
71058403|NCT01856192|141622080|SUPERIORITY|||||||0.03|||||||Log Rank|Stratified log rank test||||||0.03
71108755|NCT01114737|141722770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.8||0.522|TWO_SIDED|95.0|-1.1|2.2|||ANCOVA|Adjusted for Baseline Hamilton Rating Scale For Depression (HAM-D) Score, ADHD symptom, and ADHD medication.||||2.2|-1.1|0.522
71108756|NCT01114737|141722771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.564|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|Adjusted for Baseline Clinical Global Impression-Severity (CGI-S), ADHD symptom, and ADHD medication.||||0.4|-0.2|0.564
71108757|NCT01114737|141722772|SUPERIORITY_OR_OTHER||Relative Risk|0.87||||0.67|TWO_SIDED|95.0|0.46|1.64|||Cochran-Mantel-Haenszel|Adjusted for age group, ADHD symptom, and ADHD medication||||1.64|0.46|0.67
71058404|NCT04976621|141622098|OTHER|Because this was a feasibility study, we did not compute inferential statistics and did not include a power calculation.||||||||||||Because this was a feasibility study, inferential statistics were not computed.||||This feasibility study assessed preliminary evidence of treatment response. We have reported only descriptive statistics for quantitative findings. We have not reported inferential statistics, in keeping with the purpose of the VA SPiRE grant mechanism through which the study was funded. We assessed change in participant response by comparing the mean change in the outcome from baseline to follow-up in Group 1 (BA) and Group 2 (TAU). We inspected trends and directions of change in both groups.|Because this is a feasibility study, inferential statistics were not computed. We examined the trends and direction of change in the baseline mean score and follow-up mean score between the two groups.|||
71108758|NCT01114737|141722773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.8||0.833|TWO_SIDED|95.0|-6.2|5.0|||ANCOVA|Adjusted for Baseline BRIEF Adult-GEC T Score, ADHD symptom, and ADHD medication.||||5.0|-6.2|0.833
71108759|NCT01114737|141722774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|2.0||0.279|TWO_SIDED|95.0|-6.3|1.8|||ANCOVA|Adjusted for Baseline BRIEF Parent-GEC T Score, ADHD symptom, and ADHD medication.||||1.8|-6.3|0.279
71108760|NCT00457392|141722782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.942||||0.1933|TWO_SIDED|95.0|0.822|1.079||p-value was not adjusted for multiple comparisons.|Log Rank|||Differences in OS between treatment arms was analyzed by the 1-sided log rank test, stratified for smoking status (ever versus never), prior bevacizumab therapy (yes versus no) and epidermal growth factor receptor (EGFR) status (positive, versus negative, versus unknown).||1.079|0.822|0.1933
70851990|NCT01798849|141192317|OTHER||Difference in LS means|-6.63|||<|0.0001|TWO_SIDED|95.0|-9.35|-3.92|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-3.92|-9.35|<0.0001
71108761|NCT00457392|141722783|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.807||||0.0023|TWO_SIDED|95.0|0.695|0.937||No p-value is adjusted for multiple comparisons for PFS.|Log Rank|One-sided log-rank test with alpha=0.025 was used.||Differences in PFS between treatment arms was analyzed by the 1-sided log rank test, stratified for smoking status (ever versus never), prior bevacizumab therapy (yes versus no) and EGFR status (positive, versus negative, versus unknown).||0.937|0.695|0.0023
71025511|NCT02192905|141558579|OTHER|One-sample t-test testing the mean positive problem solving change from baseline to week 8.|Mean Difference (Final Values)|-0.64|STANDARD_DEVIATION|8.31||0.63|TWO_SIDED|95.0|-3.34|2.05|||t-test, 2 sided|||||2.05|-3.34|.63
71108762|NCT00457392|141722784|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.514||||0.0471|TWO_SIDED|95.0|1.002|2.289|||Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel (CMH) test stratified for smoking status (ever versus never), prior bevacizumab therapy (yes versus no) and EGFR status (positive, versus negative, versus unknown) was used to compare ORR between the 2 treatment arms. The relative risk ratio estimator was used to contrast the treatment effects on response rates. A point estimate of relative risk ratio and 2-sided 95% CI was calculated.||2.289|1.002|0.0471
71108763|NCT01977898|141722794|SUPERIORITY|||||||0.877|||||||Fisher Exact|||A sample size of 65 patients in each group would be required to achieve 80% power to detect this difference between intrathecal morphine and saline administration . Sample size of 64 per group achieve 80% power to detect a difference between the group proportions of 0.25. The proportion in the treatment group is assumed to be 0.5 under the null hypothesis and 0.25 under the alternative hypothesis. The proportion in the control group is .05.The significance level of the test was targeted at .05.||||.877
71108764|NCT01977898|141722795|SUPERIORITY|||||||0.499|||||||Wilcoxon (Mann-Whitney)|||||||.499
71108765|NCT01977898|141722796|SUPERIORITY|||||||0.463|||||||Chi-squared|||||||.463
71108766|NCT01977898|141722797|SUPERIORITY|||||||0.0463|||||||Chi-squared|||||||.0463
71108767|NCT01977898|141722798|SUPERIORITY|||||||0.525|||||||Chi-squared|||||||.525
70935106|NCT01604824|141370911|SUPERIORITY||LS Mean Difference|-44.64|STANDARD_ERROR_OF_MEAN|10.876|=|0.0045|TWO_SIDED|95.0|-70.36|18.92||Threshold for significance ≤ 0.05|ANCOVA|||LS means (SE), mean difference, 95% CI, and p-values were derived from ANCOVA with treatment group as factor and baseline as covariate.||18.92|-70.36|= 0.0045
71025512|NCT02192905|141558580|OTHER|One-sample t-test testing the mean within-person percent weight change from baseline to week 8.|Mean Difference (Final Values)|-0.019|STANDARD_DEVIATION|0.03|<|0.001|TWO_SIDED|95.0|-0.0285|-0.0096|||t-test, 2 sided|||||-.0096|-.0285|<0.001
71025513|NCT02192905|141558581|OTHER|One-sample t-test testing the mean within-person percent weight change from baseline to week 16.|Mean Difference (Final Values)|-0.017|STANDARD_DEVIATION|0.011||0.143|TWO_SIDED|95.0|-0.039|0.006|||t-test, 2 sided|||||.006|-.039|0.143
71108768|NCT01977898|141722799|SUPERIORITY|||||||0.691|||||||Wilcoxon (Mann-Whitney)|||||||0.691
71108769|NCT01977898|141722800|SUPERIORITY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||||||0.610
71108770|NCT01977898|141722801|SUPERIORITY|||||||0.499|||||||Wilcoxon (Mann-Whitney)|||||||.499
71108771|NCT01977898|141722802|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||.06
71108772|NCT01977898|141722803|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||.31
71108773|NCT02727322|141722809|SUPERIORITY||Risk Ratio (RR)|1.1||||0.97|TWO_SIDED|95.0|0.5|2.04|||Chi-squared|||||2.04|0.50|0.97
71108774|NCT02727322|141722810|SUPERIORITY||Risk Ratio (RR)|1.12||||0.665|TWO_SIDED|95.0|0.885|1.43|||Chi-squared|||||1.43|0.885|0.665
71108775|NCT02727322|141722811|SUPERIORITY||Risk Ratio (RR)|1.32||||1|TWO_SIDED|95.0|0.31|5.68|||Fisher Exact|||||5.68|0.31|1.0
71025514|NCT02192905|141558582|OTHER|One-sample t-test testing the mean positive problem solving change from baseline to week 16.|Mean Difference (Final Values)|-0.76|STANDARD_DEVIATION|13.07||0.73|TWO_SIDED|95.0|-5.11|3.6|||t-test, 2 sided|||||3.6|-5.11|.73
71025515|NCT04604184|141558610|OTHER||Risk Difference (RD)|-5.39||||0.3232|TWO_SIDED|95.0|-16.08|5.3|||Regression, Logistic|includes treatment, age, severity grade and creatinine at baseline, duration of symptoms before hospitalisation as covariates||||5.30|-16.08|0.3232
71108776|NCT01049373|141722827|SUPERIORITY_OR_OTHER|||||||0.0426|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0426
71025516|NCT04604184|141558611|OTHER||Risk Difference (RD)|-9.86||||0.1274|TWO_SIDED|95.0|-22.54|2.82|||Regression, Logistic|includes treatment, age, severity grade and creatinine at baseline, duration of symptoms before hospitalisation as covariates||||2.82|-22.54|0.1274
71025517|NCT04604184|141558612|OTHER||Risk Difference (RD)|2.66||||0.6828|TWO_SIDED|95.0|-10.11|15.43|||Regression, Logistic|includes treatment, age, severity grade and creatinine at baseline, duration of symptoms before hospitalisation as covariates||||15.43|-10.11|0.6828
71025518|NCT04604184|141558613|OTHER||Rate Ratio|0.67||||0.0445|TWO_SIDED|95.0|0.46|0.99|||Regression, Cox|Covariates are treatment, age, severity grade and creatinine at baseline and duration of symptoms before hospitalization||||0.99|0.46|0.0445
71108777|NCT01049373|141722828|SUPERIORITY_OR_OTHER|||||||0.0757|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0757
71108778|NCT01049373|141722829|SUPERIORITY_OR_OTHER|||||||0.0465|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0465
71108779|NCT01049373|141722830|SUPERIORITY_OR_OTHER|||||||0.04443|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.04443
71108780|NCT00339040|141722843|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Fisher Exact|||||||1.00
71108781|NCT00988156|141722850|SUPERIORITY_OR_OTHER|||||||0.249|||||||ANCOVA|||||||0.2490
71108782|NCT00988156|141722851|SUPERIORITY_OR_OTHER|||||||0.9017|||||||Cochran-Mantel-Haenszel|||||||0.9017
71108783|NCT01815424|141722861|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.52|||<|0.0001|TWO_SIDED|95.0|6.03|32.77||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for tofacitinib 10 mg vs placebo at Week 16; PASI75 response for tofacitinib 10 mg vs placebo at Week 16; PGA response for tofacitinib 5 mg vs placebo at Week 16; PASI75 response for tofacitinib 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||32.77|6.03|<0.0001
71108784|NCT01815424|141722861|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.27|||<|0.0001|TWO_SIDED|95.0|2.46|11.86||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for tofacitinib 10 mg vs placebo at Week 16; PASI75 response for tofacitinib 10 mg vs placebo at Week 16; PGA response for tofacitinib 5 mg vs placebo at Week 16; PASI75 response for tofacitinib 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||11.86|2.46|<0.0001
71025519|NCT04604184|141558614|OTHER||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|1.35||0.5526|TWO_SIDED|95.0|-3.47|1.87|||ANCOVA|Fixed effects of treatment, age, severity grade and creatinine at baseline and duration of symptoms before hospitalisation as covariates|Difference = covariate adjusted BI 764198 - covariate adjusted Placebo|||1.87|-3.47|0.5526
71025520|NCT04604184|141558615|OTHER||Risk Difference (RD)|5.32||||0.0995|TWO_SIDED|95.0|-1.01|11.65|||Regression, Logistic|Includes treatment, age, severity grade and creatinine at baseline, and duration of symptoms before hospitalisation as covariates||Day 15||11.65|-1.01|0.0995
71025521|NCT04604184|141558615|OTHER||Risk Difference (RD)|6.06||||0.1992|TWO_SIDED|95.0|-3.19|15.31|||Regression, Logistic|Includes treatment, age, severity grade and creatinine at baseline, and duration of symptoms before hospitalisation as covariates||Day 29||15.31|-3.19|0.1992
71025522|NCT04604184|141558615|OTHER||Risk Difference (RD)|8.93||||0.0709|TWO_SIDED|95.0|-0.76|18.62|||Regression, Logistic|Includes treatment, age, severity grade and creatinine at baseline, and duration of symptoms before hospitalisation as covariates||Day 60||18.62|-0.76|0.0709
71025523|NCT04604184|141558615|OTHER||Risk Difference (RD)|10.35||||0.0412|TWO_SIDED|95.0|0.41|20.28|||Regression, Logistic|Includes treatment, age, severity grade and creatinine at baseline, and duration of symptoms before hospitalisation as covariates||Day 90||20.28|0.41|0.0412
71025524|NCT03513497|141558616|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
71025525|NCT03513497|141558617|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
71025526|NCT03513497|141558618|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.6
71025527|NCT03513497|141558619|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
71025528|NCT03294538|141558622|EQUIVALENCE|If the adjusted 90% confidence interval on the difference between proportions of participants considered Responders in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group was contained within the equivalence range \[-0.20, +0.20\], then treatment with generic estradiol vaginal cream and treatment with Estrace Vaginal Cream were considered therapeutically equivalent.|Odds Ratio (OR)|0.7|||||TWO_SIDED|90.0|-5.8|7.2||||||Therapeutic equivalence of the generic estradiol vaginal cream group to the Estrace Vaginal Cream group based on the primary endpoint was evaluated in the PP population.||7.2|-5.8|
71025529|NCT03294538|141558623|SUPERIORITY|The proportion of participants considered as Responders in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group were each compared to the proportion of Responders in the vehicle vaginal cream group. If both the generic estradiol vaginal cream group and the Estrace Vaginal Cream group demonstrated a statistically significant greater proportion of Responders than the vehicle vaginal cream group, then superiority was concluded.|Odds Ratio (OR)|19.9|||<|0.0001|||||||Cochran-Mantel-Haenszel|||Superiority of the generic estradiol vaginal cream group and the Estrace Vaginal Cream group to the vehicle vaginal cream group based on the primary endpoint was evaluated in the mITT population.||||<0.0001
71025530|NCT03294538|141558623|SUPERIORITY|The proportion of participants considered as Responders in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group were each compared to the proportion of Responders in the vehicle vaginal cream group. If both the generic estradiol vaginal cream group and the Estrace Vaginal Cream group demonstrated a statistically significant greater proportion of Responders than the vehicle vaginal cream group, then superiority was concluded.|Odds Ratio (OR)|20.2|||<|0.0001|||||||Cochran-Mantel-Haenszel|||Superiority of the generic estradiol vaginal cream group and the Estrace Vaginal Cream group to the vehicle vaginal cream group based on the primary endpoint was evaluated in the mITT population.||||<0.0001
71025531|NCT03294538|141558624|EQUIVALENCE|If the adjusted 90% confidence interval on the difference between proportions of participants considered Treatment Success in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group was contained within the equivalence range \[-0.20, +0.20\], then treatment with generic estradiol vaginal cream and treatment with Estrace Vaginal Cream were considered therapeutically equivalent.|Odds Ratio (OR)|-1.4|||||TWO_SIDED|90.0|-9.0|6.2||||||Therapeutic equivalence of the generic estradiol vaginal cream group to the Estrace Vaginal Cream group based on the secondary endpoint was evaluated in the PP population.||6.2|-9.0|
71058405|NCT04976621|141622099|OTHER|||||||||||||||||This feasibility study assessed preliminary evidence of treatment response. We have reported only descriptive statistics for quantitative findings. We have not reported inferential statistics, in keeping with the purpose of the VA SPiRE grant mechanism through which the study was funded. We assessed change in participant response by comparing the mean change in the outcome from baseline to follow-up in Group 1 (BA) and Group 2 (TAU). We inspected trends and directions of change in both groups.|Because this is a feasibility study, inferential statistics were not computed. We examined the trends and direction of change in the baseline mean score and follow-up mean score between the two groups.|||
71058406|NCT04976621|141622100|OTHER|||||||||||||||||This feasibility study assessed preliminary evidence of treatment response. We have reported only descriptive statistics for quantitative findings. We have not reported inferential statistics, in keeping with the purpose of the VA SPiRE grant mechanism through which the study was funded. We assessed change in participant response by comparing the mean change in the outcome from baseline to follow-up in Group 1 (BA) and Group 2 (TAU). We inspected trends and directions of change in both groups.|Because this is a feasibility study, inferential statistics were not computed. We examined the trends and direction of change in the baseline mean score and follow-up mean score between the two groups.|||
71058407|NCT04976621|141622101|OTHER||||||||||||||||||This analysis involved examination of the percentage that scored above a mean of 3.0 (our criteria for acceptability in this feasibility study).|||
70935107|NCT01604824|141370912|SUPERIORITY||LS Mean Difference|-49.37|STANDARD_ERROR_OF_MEAN|11.487|=|0.0016|TWO_SIDED|95.0|-74.96|-23.77||Threshold for significance ≤ 0.05|ANCOVA|||||-23.77|-74.96|= 0.0016
71025532|NCT03294538|141558625|SUPERIORITY|The proportion of participants considered as Treatment Success in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group were each compared to the proportion of Treatment Success in the vehicle vaginal cream group. If both the generic estradiol vaginal cream group and the Estrace Vaginal Cream group demonstrated a statistically significant greater proportion of Treatment Success than the vehicle vaginal cream group, then superiority was concluded.|Odds Ratio (OR)|4.9||||0.2897|||||||Cochran-Mantel-Haenszel|||Superiority of the generic estradiol vaginal cream group and the Estrace Vaginal Cream group to the vehicle vaginal cream group based on the secondary endpoint was evaluated in the mITT population.||||0.2897
71108785|NCT01815424|141722862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|41.71|||<|0.0001|TWO_SIDED|95.0|14.84|151.11||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for tofacitinib 10 mg vs placebo at Week 16; PASI75 response for tofacitinib 10 mg vs placebo at Week 16; PGA response for tofacitinib 5 mg vs placebo at Week 16; PASI75 response for tofacitinib 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||151.11|14.84|<0.0001
71025533|NCT03294538|141558625|SUPERIORITY|The proportion of participants considered as Treatment Success in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group were each compared to the proportion of Treatment Success in the vehicle vaginal cream group. If both the generic estradiol vaginal cream group and the Estrace Vaginal Cream group demonstrated a statistically significant greater proportion of Treatment Success than the vehicle vaginal cream group, then superiority was concluded.|Odds Ratio (OR)|3.9||||0.4949|||||||Cochran-Mantel-Haenszel|||Superiority of the generic estradiol vaginal cream group and the Estrace Vaginal Cream group to the vehicle vaginal cream group based on the primary endpoint was evaluated in the mITT population.||||0.4949
71025534|NCT01787825|141558630|NON_INFERIORITY|This is McNemar design.|percentage concordance|77.19||||1|TWO_SIDED|95.0|68.68|83.93||The blinded readers assessed concordance of normal versus abnormal and overall concordance of clinically significant abnormal images.|McNemar||Overall concordance of clinically significant abnormal images.|There was a comparison between normal and abnormal images. And detailed analysis of abnormal images that were considered clinical significant.||83.93|68.68|1.0000
71058408|NCT04976621|141622102|OTHER|||||||||||||||||Descriptive statistics are used to describe acceptability/satisfaction for those who received the BA intervention. This tool is completed after the last intervention session when the qualitative interview is also conducted.|Descriptive statistics are used in this feasibility study. We are not using inferential statistics to test for statistical significance.|||
71058409|NCT04976621|141622103|OTHER||||||||||||||||||Descriptive statistics are used to describe recruitment.|||
71058410|NCT04976621|141622104|OTHER||||||||||||||||||One measure of retention was the percent in each group who completed the study, meaning completed the Time 2 follow-up interview (that occurred 3-4 months after the baseline interview). Another measure of retention was the percent in the treatment group that completed four or more treatment sessions.|||
70935108|NCT01604824|141370912|SUPERIORITY||LS Mean Difference|-40.36|STANDARD_ERROR_OF_MEAN|10.471|=|0.0063|TWO_SIDED|95.0|-65.12|15.6||Threshold for significance ≤ 0.05|ANCOVA|||||15.60|-65.12|= 0.0063
71025535|NCT01787825|141558632|SUPERIORITY_OR_OTHER||percentage concordance|71.93||||0.972|TWO_SIDED|95.0|63.07|79.36|||Bowkers|||||79.36|63.07|0.972
71025536|NCT01602614|141558678|OTHER|Spearman Rank Correlation||||||0.3117|||||||Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.3117
71025537|NCT01602614|141558679|OTHER|Spearman Rank Correlation||||||0.6175||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.6175
71025538|NCT01602614|141558680|OTHER|Spearman Rank Correlation||||||0.7129||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.7129
71025539|NCT01602614|141558681|OTHER|Spearman Rank Correlation||||||0.9828|||||||Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.9828
71025540|NCT01602614|141558682|OTHER|Spearman Rank Correlation||||||0.9656|||||||Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.9656
71025541|NCT01602614|141558683|OTHER|Spearman Rank Correlation||||||0.5113|||||||Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.5113
71025542|NCT01602614|141558684|OTHER|Spearman Rank Correlation||||||0.217||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.2170
71025543|NCT01602614|141558685|OTHER|Spearman Rank Correlation||||||0.4299||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.4299
71025544|NCT01602614|141558686|OTHER|Spearman Rank Correlation||||||0.8629||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.8629
71025545|NCT01602614|141558687|OTHER|Spearman Rank Correlation||||||0.5717||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.5717
71025546|NCT01798485|141558688|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.111||||0.3293|TWO_SIDED|95.0|0.899|1.372|||Log Rank|P-value was from stratified log-rank test (strata: screening LDH, screening ECOG and geographic region).||Primary study hypothesis was tested at a 2-sided, 0.05 significance level using a stratified log-rank test.||1.372|0.899|0.3293
71058411|NCT04976621|141622105|OTHER||||||||||||||||||For each of five participants who received the intervention, we reviewed a transcript of 1 intervention session for treatment fidelity. The criterion is that no more than 15% of sessions observed or audiotaped will have a mean less than 2.0.|||
71058412|NCT05992623|141622106|SUPERIORITY|||||||0.565|||||||Chi-squared|||||||0.565
71058413|NCT05992623|141622107|SUPERIORITY|||||||0.617|||||||Chi-squared|||||||0.617
71058414|NCT05992623|141622108|SUPERIORITY||Mean Difference (Final Values)|0.04|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
71058415|NCT02466685|141622254|SUPERIORITY||Mean Difference (Final Values)|5.0|STANDARD_DEVIATION|9.4|<|0.05|TWO_SIDED||||||ANCOVA|||||||<0.05
70935109|NCT01604824|141370913|SUPERIORITY||LS Mean Difference|-30.75|STANDARD_ERROR_OF_MEAN|7.224|=|0.0017|TWO_SIDED|95.0|-46.85|-14.66||Threshold for significance ≤ 0.05|ANCOVA|||||-14.66|-46.85|= 0.0017
71025547|NCT01798485|141558688|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.111|||||TWO_SIDED|99.5|0.821|1.503||||||"Futility analysis for the first Interim Analysis which had a database cutoff of 19 October 2015. For the first interim analysis, if the lower limit of the 2-sided 99.5% confidence interval (CI) for the Hazard Ratio was greater than 0.75, then the study could be stopped for futility, based on Data Monitoring Committee recommendation.~Hazard ratio and 99.5% CI were calculated using the stratified Cox Proportional Hazards model (strata: screening LDH, screening ECOG and geographic region)."||1.503|0.821|
71025548|NCT01798485|141558689|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.161||||0.118|TWO_SIDED|95.0|0.961|1.403||Significance level of 0.05.|Log Rank|Stratified log-rank test with stratification variables, ECOG, screening total LDH levels, and geographic region, used to compare the treatment groups.||||1.403|0.961|0.1180
71025549|NCT01798485|141558690|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.232||||0.2506|TWO_SIDED|95.0|0.865|1.754||Significance level of 0.05.|Log Rank|P-value was from stratified log-rank test (strata: screening ECOG and geographic region).||||1.754|0.865|0.2506
71058416|NCT04739800|141622272|EQUIVALENCE|This is the Hazard Ratio of Group 2 compared to Group 1.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.44|2.31|||||This is the Hazard Ratio of Group 2 compared to Group 1.|||2.31|0.44|
71025550|NCT01798485|141558691|SUPERIORITY_OR_OTHER|||||||0.448|TWO_SIDED|||||Significance level of 0.05.|Fisher Exact|||||||0.448
71025551|NCT01798485|141558692|SUPERIORITY_OR_OTHER|||||||0.339|TWO_SIDED|||||Significance level of 0.05.|Fisher Exact|||\>= 6 weeks||||0.339
71025552|NCT01798485|141558692|SUPERIORITY_OR_OTHER|||||||0.817|TWO_SIDED|||||Significance level of 0.05.|Fisher Exact|||\>= 12 weeks||||0.817
71025553|NCT01798485|141558693|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.344||||0.0111|TWO_SIDED|95.0|1.207|4.551||Significance level of 0.05.|Log Rank|P-value was from stratified log-rank test (strata: screening LDH, screening ECOG and geographic region).||||4.551|1.207|0.0111
71025554|NCT01798485|141558694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.112||||0.5191|TWO_SIDED|95.0|0.797|1.551||Significance level of 0.05.|Log Rank|P-value was from stratified log-rank test (strata: screening ECOG and geographic region).||||1.551|0.797|0.5191
71025555|NCT01798485|141558697|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.233||||0.1343|TWO_SIDED|95.0|0.937|1.621||Significance level of 0.05.|Log Rank|Stratified log-rank test (strata: screening LDH, screening ECOG and geographic region).||||1.621|0.937|0.1343
71025556|NCT01798485|141558698|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED|||||Significance level of 0.05.|Fisher Exact|||||||0.250
71025557|NCT02970669|141558729|SUPERIORITY||Ratio of Geometric Means (SacVal/Ena)|0.9456||||0.0895|TWO_SIDED|95.0|0.8863|1.0088|||ANCOVA|model for a log-scaled response with treatment group as a class variable and the baseline value in logarithmic scale as a continuous covariate.||||1.0088|0.8863|0.0895
71025558|NCT02970669|141558730|SUPERIORITY||Mean Difference (Net)|293.6||||0.6316|TWO_SIDED|95.0|-916.5|1503.8|||ANCOVA|model with treatment group as a class variable and the baseline value as a continuous covariate.||||1503.8|-916.5|0.6316
71025559|NCT02970669|141558732|SUPERIORITY||Mean Difference (Net)|2.038||||0.057|TWO_SIDED|95.0|-0.062|4.138|||ANCOVA|model with treatment group as a class variable and the baseline value as a continuous covariate.||||4.138|-0.062|0.0570
71058417|NCT04739800|141622272|EQUIVALENCE|This is the Hazard Ratio of Group 3 compared to Group 1.|Hazard Ratio (HR)|1.21|||||TWO_SIDED|95.0|0.52|2.84|||||This is the Hazard Ratio of Group 3 compared to Group 1.|||2.84|0.52|
70935110|NCT01604824|141370913|SUPERIORITY||LS Mean Difference|-22.23|STANDARD_ERROR_OF_MEAN|6.294|=|0.0096|TWO_SIDED|95.0|-37.11|-7.34||Threshold for significance ≤ 0.05|ANCOVA|||||-7.34|-37.11|= 0.0096
70935111|NCT01604824|141370914|SUPERIORITY||LS Mean Difference|-49.72|STANDARD_ERROR_OF_MEAN|9.867|=|0.0005|TWO_SIDED|95.0|-71.71|-27.74||Threshold for significance ≤ 0.05|ANCOVA|||||-27.74|-71.71|= 0.0005
70935112|NCT01604824|141370914|SUPERIORITY||LS Mean Difference|-49.33|STANDARD_ERROR_OF_MEAN|11.545|=|0.0037|TWO_SIDED|95.0|-76.63|-22.03||Threshold for significance ≤ 0.05|ANCOVA|||||-22.03|-76.63|= 0.0037
70935113|NCT03775213|141370926|SUPERIORITY||Risk Ratio (RR)|1.53|||||TWO_SIDED|95.0|0.91|2.58||||||||2.58|.91|
70935114|NCT03775213|141370927|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.49|1.88||||||Active Monitoring||1.88|.49|
70935115|NCT03775213|141370927|SUPERIORITY||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.79|1.41||||||Lumpectomy||1.41|.79|
71025560|NCT02970669|141558733|SUPERIORITY||Mean Difference (Net)|2.478||||0.0121|TWO_SIDED|95.0|0.553|4.403|||ANCOVA|model with treatment group as a class variable and the baseline value as a continuous covariate.||||4.403|0.553|0.0121
71025561|NCT00249821|141558743|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||"Month 12: Analysis of co-variance (ANCOVA) method with covariates height and age at baseline was used to calculate presented p-value."||||0.001
71025562|NCT00249821|141558744|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||ANCOVA|||"Change at Month 6: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.012
71025563|NCT00249821|141558744|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||"Change at Month 12: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.002
71025564|NCT00249821|141558745|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||ANCOVA|||"Month 6: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.022
71025565|NCT00249821|141558745|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||"Month 12: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.002
71025566|NCT00249821|141558746|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||ANCOVA|||"Change at Month 6: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.029
71058418|NCT04739800|141622272|EQUIVALENCE|This is the Hazard Ratio of Group 4 compared to Group 1.|Hazard Ratio (HR)|1.34|||||TWO_SIDED|95.0|0.58|3.08|||||||This is the Hazard Ratio of Group 4 compared to Group 1.|3.08|0.58|
71058419|NCT04739800|141622275|EQUIVALENCE|This is the Hazard Ratio of Group 2 compared to Group 1.|Hazard Ratio (HR)|1.41|||||TWO_SIDED|95.0|0.44|4.47|||||This is the Hazard Ratio for Group 2 compared to Group 1.|||4.47|0.44|
71108786|NCT01815424|141722862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.97|||<|0.0001|TWO_SIDED|95.0|4.06|25.17||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for tofacitinib 10 mg vs placebo at Week 16; PASI75 response for tofacitinib 10 mg vs placebo at Week 16; PGA response for tofacitinib 5 mg vs placebo at Week 16; PASI75 response for tofacitinib 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||25.17|4.06|<0.0001
71108787|NCT01815424|141722863|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-71.54|STANDARD_ERROR_OF_MEAN|8.461|<|0.0001|TWO_SIDED|95.0|-88.2|-54.87||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).|Mixed Models Analysis|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||-54.87|-88.20|<0.0001
71108788|NCT01815424|141722863|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-52.12|STANDARD_ERROR_OF_MEAN|8.416|<|0.0001|TWO_SIDED|95.0|-68.7|-35.55||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Mixed Models Analysis|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||-35.55|-68.70|<0.0001
71108789|NCT01815424|141722864|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|70.31|||<|0.0001|TWO_SIDED|95.0|13.38|267.15||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||267.15|13.38|<0.0001
71108790|NCT01815424|141722864|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.44|||<|0.0001|TWO_SIDED|95.0|4.31|79.62||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||79.62|4.31|<0.0001
71108791|NCT01815424|141722865|SUPERIORITY_OR_OTHER||Least square mean difference|-7.52|STANDARD_ERROR_OF_MEAN|0.913|<|0.0001|TWO_SIDED|95.0|-9.32|5.72||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).|Mixed Models Analysis|||Week 16. This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||5.72|-9.32|<0.0001
71108792|NCT01815424|141722865|SUPERIORITY_OR_OTHER||Least square mean difference|-5.45|STANDARD_ERROR_OF_MEAN|0.907|<|0.0001|TWO_SIDED|95.0|-7.24|-3.67||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).|Mixed Models Analysis|||Week 16. This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||-3.67|-7.24|<0.0001
70935116|NCT03775213|141370927|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.62|1.3||||||Lumpectomy with Radiation||1.30|.62|
70935117|NCT03775213|141370927|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.48|1.47||||||Mastectomy||1.47|.48|
70935118|NCT03775213|141370928|SUPERIORITY||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.59|1.98||||||||1.98|.59|
71025567|NCT00249821|141558747|SUPERIORITY_OR_OTHER|||||||0.972||95.0|||||ANCOVA|||"Change at Month 12: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.972
71025568|NCT00249821|141558748|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||ANCOVA|||"Month 6: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.058
71025569|NCT00249821|141558748|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||ANCOVA|||"Month 12: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.026
71025570|NCT00249821|141558749|SUPERIORITY_OR_OTHER|||||||0.793||95.0|||||ANCOVA|||"Month 6: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.793
71025571|NCT00249821|141558749|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||ANCOVA|||"Month 12: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.055
71025572|NCT01202747|141558762|SUPERIORITY_OR_OTHER|||||||0.0005||||||p\<0.05 considered statistically significant|Regression, Linear|||||||0.0005
71025573|NCT02292238|141558773|OTHER||Mean Difference (Net)|1.8691|STANDARD_DEVIATION|5.5727||0.125|TWO_SIDED|||||Univariable (unadjusted) and a priori threshold for statistical significance is 0.05.|t-test, 2 sided|Equal variance t-test.||Power was calculated based on expected difference in change on the ADAS-Cog of 3 points between the treatment and control groups. Estimates based on using a two-sided alpha of 0.05 and a standard deviation of 4, enrolling 29 patients per group, (N = 58) suggest 80% power to detect a mean change of 3 between treatment and placebo.||||0.125
71025574|NCT02292238|141558774|OTHER|Univariable (unadjusted) and a priori threshold for statistical significance is 0.05.|Mean Difference (Net)|-0.00184|STANDARD_DEVIATION|0.0225||0.7529|TWO_SIDED||||||t-test, 2 sided|Equal variance t-test.||||||0.7529
71025575|NCT02292238|141558775|OTHER|Univariable (unadjusted) and a priori threshold for statistical significance is 0.05.|Mean Difference (Net)|-1.0636|STANDARD_DEVIATION|4.8176||0.3687|TWO_SIDED||||||t-test, 2 sided|Equal variance t-test.||||||0.3687
71025576|NCT02292238|141558776|OTHER||Mean Difference (Net)|1.8203|STANDARD_DEVIATION|13.8988||0.485|TWO_SIDED||||||t-test, 2 sided|Equal variance t-test.||||||0.4850
71025577|NCT02292238|141558777|OTHER||Mean Difference (Net)|0.1907|STANDARD_DEVIATION|0.3097||0.0337|TWO_SIDED|||||The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|Equal variance t-test.||||||0.0337
71025578|NCT02292238|141558778|OTHER|Univariable (unadjusted) and a priori threshold for statistical significance is 0.05.|Mean Difference (Net)|-1.6161|STANDARD_DEVIATION|5.6812||0.315|TWO_SIDED||||||t-test, 2 sided|Equal variance t-test.||||||0.315
71025579|NCT03387033|141558790|OTHER||||||<|0.005|||||||Paired t-test|||||||<0.005
71025580|NCT03387033|141558791|OTHER||||||<|0.05|||||||Paired t-test|||||||<0.05
71058420|NCT04739800|141622275|EQUIVALENCE|This is the Hazard Ratio of Group 3 compared to Group 1.|Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.4|4.19|||||This is the Hazard Ratio of Group 3 compared to Group 1.|||4.19|0.40|
71058421|NCT04739800|141622275|EQUIVALENCE|This is the Hazard Ratio of Group 4 compared to Group 1.|Hazard Ratio (HR)|1.34|||||TWO_SIDED|95.0|0.58|3.08|||||This is the Hazard Ratio of Group 4 compared to Group 1.|||3.08|0.58|
71058422|NCT01906515|141622284|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
71058423|NCT01906515|141622285|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70935119|NCT03775213|141370929|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.65|1.45||||||||1.45|.65|
71025581|NCT03387033|141558792|OTHER||||||<|0.05|||||||Paired t-test|||||||<0.05
71025582|NCT00601484|141558793|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|-1.36|STANDARD_ERROR_OF_MEAN|0.503|||TWO_SIDED|90.0|-2.203|-0.51||||||Analysis was based on analysis of covariance (ANCOVA) model with terms for treatment, age, gender, body mass index (BMI), baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.510|-2.203|
70935120|NCT03775213|141370930|SUPERIORITY||Slope|0.09|||||TWO_SIDED|95.0|-0.2|0.38||||||||.38|-.20|
71025583|NCT00601484|141558794|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.68|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|90.0|-1.363|0.011||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.011|-1.363|
71025584|NCT00601484|141558794|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.13|STANDARD_ERROR_OF_MEAN|0.498|||TWO_SIDED|90.0|-1.969|-0.297||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.297|-1.969|
71025585|NCT00601484|141558794|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.85|STANDARD_ERROR_OF_MEAN|0.559|||TWO_SIDED|90.0|-1.79|0.09||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.090|-1.790|
71025586|NCT00601484|141558794|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.538|||TWO_SIDED|90.0|-1.356|0.457||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.457|-1.356|
71058424|NCT02454608|141622325|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mixed Models Analysis|||||||0.01
71058425|NCT02454608|141622326|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||||||0.001
71058426|NCT02454608|141622327|SUPERIORITY_OR_OTHER|||||||0.25|||||||Mixed Models Analysis|||||||0.25
71058427|NCT02454608|141622328|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
71058428|NCT02454608|141622329|SUPERIORITY_OR_OTHER|||||||0.6|||||||t-test, 2 sided|||||||0.6
71058429|NCT02454608|141622330|SUPERIORITY_OR_OTHER|||||||0.78|||||||t-test, 2 sided|||||||0.78
71058430|NCT02454608|141622331|SUPERIORITY_OR_OTHER|||||||0.7|||||||t-test, 2 sided|||||||0.7
71058431|NCT01769456|141622335|OTHER||||||<|0.0001||||||Reported p-value is the calculated value provided by SAS output.|Wilcoxon Signed Rank Test|||||||< 0.0001
71058432|NCT01769456|141622336|OTHER|||||||0.0236|||||||Wilcoxon Signed Rank Test|||||||0.0236
71058433|NCT01769456|141622337|OTHER|||||||0.0003|||||||Wilcoxon Signed Rank Test|||||||0.0003
71058434|NCT01769456|141622338|OTHER|||||||0.0236|||||||Wilcoxon Signed Rank Test|||||||0.0236
71058435|NCT05490771|141622362|SUPERIORITY|||||||0.0341|||||||one-sided exact binomial test|||The ORR was compared against a null benchmark value of 5%. If the observed ORR were ≥5 of 31 (16%), it would then be concluded that the agent is promising and worthy of further investigation. When the number of analyzable cases (who were eligible and treated, and with outside assay results confirmed by the central MATCH assay) was \<31, the one-sided exact binomial test would be used for significance test with one-side type I error rate of 5%.||||0.0341
71058436|NCT03126435|141622405|SUPERIORITY|||||||0.6647|||||||Log Rank|P-Value is from a stratified log-rank test.||||||0.6647
71058437|NCT03126435|141622406|SUPERIORITY|||||||0.4345|||||||Log Rank|P-Value is from a stratified log-rank test.||||||0.4345
71058438|NCT03126435|141622407|SUPERIORITY|||||||0.2632|||||||Regression, Logistic|P-value is from logistic regression model adjusted for stratification factors among non-missing records||||||0.2632
71058439|NCT03126435|141622409|SUPERIORITY|||||||0.1002|||||||Regression, Logistic|P-value is from logistic regression model adjusted for stratification factors among non-missing records.||||||0.1002
71108793|NCT01815424|141722866|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|114.4|||<|0.0001|TWO_SIDED|95.0|8.95|2657.62||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant,only then subsequent comparison was tested at the below specified significance level.||2657.62|8.95|<0.0001
70851991|NCT01798849|141192318|OTHER||Difference in LS means|-2.67||||0.128|TWO_SIDED|95.0|-6.14|0.8|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.80|-6.14|0.128
70851992|NCT01798849|141192318|OTHER||Difference in LS means|-0.76||||0.305|TWO_SIDED|95.0|-2.24|0.72|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.72|-2.24|0.305
70851993|NCT01798849|141192318|OTHER||Difference in LS means|-2.03||||0.07|TWO_SIDED|95.0|-4.23|0.17|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.17|-4.23|0.070
70851994|NCT01798849|141192318|OTHER||Difference in LS means|-2.84||||0.036|TWO_SIDED|95.0|-5.48|-0.19|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-0.19|-5.48|0.036
70851995|NCT01798849|141192318|OTHER||Difference in LS means|-4.89|||<|0.0001|TWO_SIDED|95.0|-6.4|-3.37|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-3.37|-6.40|<0.0001
70851996|NCT01798849|141192318|OTHER||Difference in LS means|-5.37|||<|0.0001|TWO_SIDED|95.0|-7.29|-3.46|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-3.46|-7.29|<0.0001
70851997|NCT01798849|141192318|OTHER||Difference in LS means|-5.68|||<|0.0001|TWO_SIDED|95.0|-6.7|-4.65|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-4.65|-6.70|<0.0001
70851998|NCT01798849|141192318|OTHER||Difference in LS means|-8.22|||<|0.0001|TWO_SIDED|95.0|-11.95|-4.5|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-4.50|-11.95|<0.0001
70851999|NCT01798849|141192319|OTHER||Difference in LS means|-1.77||||0.212|TWO_SIDED|95.0|-4.59|1.05|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||1.05|-4.59|0.212
70852000|NCT01798849|141192319|OTHER||Difference in LS means|3.32||||0.05|TWO_SIDED|95.0|0.0|6.64|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||6.64|0.00|0.050
71058440|NCT03126435|141622410|SUPERIORITY|||||||0.9882|||||||Regression, Logistic|P-value is from logistic regression model adjusted for stratification factors among non-missing records.||||||0.9882
71077945|NCT02913105|141664399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.1||||0.016|TWO_SIDED|90.0|1.03|1.18|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 7||1.18|1.03|0.0160
71108794|NCT01815424|141722866|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|35.37|||<|0.0001|TWO_SIDED|95.0|3.47|1084.02||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||1084.02|3.47|<0.0001
71108795|NCT01815424|141722867|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|OR and 95% CI not available due to 0% frequency in placebo group.||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||||<0.0001
71108796|NCT01815424|141722867|SUPERIORITY_OR_OTHER|||||||0.0386||||||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|OR and 95% CI not available due to 0% frequency in placebo group.||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||||0.0386
71108797|NCT01815424|141722868|SUPERIORITY_OR_OTHER||Least square mean difference|-5.09|STANDARD_ERROR_OF_MEAN|0.709|<|0.0001|TWO_SIDED|95.0|-6.49|-3.7||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).|Mixed Models Analysis|||Week 4. This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||-3.70|-6.49|<0.0001
71108798|NCT01815424|141722868|SUPERIORITY_OR_OTHER||Least square mean difference|-4.2|STANDARD_ERROR_OF_MEAN|0.706|<|0.0001|TWO_SIDED|95.0|-5.59|-2.81||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).|Mixed Models Analysis|||Week 4. This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||-2.81|-5.59|<0.0001
71108799|NCT01815424|141722869|SUPERIORITY_OR_OTHER||Least square mean of difference|-41.23|STANDARD_ERROR_OF_MEAN|15.977||0.0113|TWO_SIDED|95.0|-72.91|-9.54||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Mixed Models Analysis|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||-9.54|-72.91|0.0113
71108800|NCT01815424|141722869|SUPERIORITY_OR_OTHER||Least square mean of difference|-22.89|STANDARD_ERROR_OF_MEAN|16.01||0.1558|TWO_SIDED|95.0|-54.64|8.86||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Mixed Models Analysis|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||8.86|-54.64|0.1558
71108801|NCT00328172|141722984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.3271||95.0|-0.41|0.14|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline HbA1c as a linear covariate.||Linagliptin 0.5 mg versus placebo||0.14|-0.41|0.3271
71108802|NCT00328172|141722984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.0032||95.0|-0.69|-0.14|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline HbA1c as a linear covariate.||Linagliptin 2.5 mg versus placebo||-0.14|-0.69|0.0032
71108803|NCT00328172|141722984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0012||95.0|-0.74|-0.18|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline HbA1c as a linear covariate.||Linagliptin 5.0 mg versus placebo||-0.18|-0.74|0.0012
70852001|NCT01798849|141192319|OTHER||Difference in LS means|2.48||||0.016|TWO_SIDED|95.0|0.49|4.47|||Mixed effect model||Difference in LS means = LS mean MK-8892 minus LS mean placebo|||4.47|0.49|0.016
70941707|NCT04748445|141383934|OTHER||Slope|0.007716|STANDARD_ERROR_OF_MEAN|5.746||0.1818|TWO_SIDED|90.0|-0.001806|0.01724|||Mixed Models Analysis|||READ\_MFCC std 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.01724|-0.001806|0.1818
70935121|NCT04821271|141370947|OTHER|Treatment comparison||||||0.91|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.91
70941708|NCT04748445|141383934|OTHER||Slope|-0.004019|STANDARD_ERROR_OF_MEAN|6.419||0.5324|TWO_SIDED|90.0|-0.01466|0.006618|||Mixed Models Analysis|||READ\_MFCC std 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.006618|-0.01466|0.5324
71058441|NCT03971474|141622416|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.05|TWO_SIDED|80.0|0.51|0.92||If either P value from the two tests (standard stratified log-rank and weighted log-rank) was \< 0.0972, the study would be considered to have rejected the null at the one-sided 10% level.|Log Rank|Testing was performed using a standard stratified log-rank test.|Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model including the stratification factors (PD-L1 status and histology) and 80% CIs.|Comparison of OS was performed using a standard stratified log-rank test and a weighted log-rank test. The study had 90% power to detect the scenario with overlapping curves up to 3 months and a hazard ratio of 0.5 after 3 months, assuming exponentially distributed survival times, a median OS of 10.5 months in the SOC arm, and uniform accrual over 21-24 months. This analysis reports the standard stratified log-rank test.||0.92|0.51|0.05
71058442|NCT03971474|141622416|SUPERIORITY|||||||0.15||||||If either p-value from the two tests (standard stratified log-rank and weighted log-rank) was \< 0.0972, the study would be considered to have rejected the null at the one-sided 10% level.|Log Rank|||Comparison of OS was performed using a standard stratified log-rank test and a weighted log-rank test. The study had 90% power to detect the scenario with overlapping curves up to 3 months and a hazard ratio of 0.5 after 3 months, assuming exponentially distributed survival times, a median OS of 10.5 months in the SOC arm, and uniform accrual over 21-24 months. This analysis reports the weighted log-rank test.||||0.15
71058443|NCT03971474|141622417|SUPERIORITY|||||||0.19||||||Proportions were compared using a chi-squared test at the one-sided 5% level.|Chi-squared|||||||0.19
71058444|NCT03971474|141622418|SUPERIORITY|||||||0.38||||||Proportions were compared using a chi-squared test at the one-sided 5% level.|Chi-squared|||||||0.38
71058445|NCT03971474|141622421|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.25|TWO_SIDED|80.0|0.66|1.14|||Log Rank|Testing was performed using a standard stratified log-rank test.|Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model including the stratification factors (PD-L1 status and histology) and 80% CIs.|Comparison of IA-PFS was performed using a standard stratified log-rank test and a weighted log-rank test with weights equal to 1-S(t), where S(t) is the pooled survival estimate at time t (G\[rho=0, gamma=1\]). The weighted test weights later events over earlier events and has more power than the standard log-rank test under a delayed separation in the curves. This analysis reports the standard stratified log-rank test.||1.14|0.66|0.25
70852002|NCT01798849|141192319|OTHER||Difference in LS means|5.21||||0.007|TWO_SIDED|95.0|1.51|8.92|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||8.92|1.51|0.007
70852003|NCT01798849|141192319|OTHER||Difference in LS means|7.06||||0.001|TWO_SIDED|95.0|3.03|11.1|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||11.10|3.03|0.001
70852004|NCT01798849|141192319|OTHER||Difference in LS means|6.62||||0.002|TWO_SIDED|95.0|2.54|10.71|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||10.71|2.54|0.002
70852005|NCT01798849|141192319|OTHER||Difference in LS means|8.11|||<|0.0001|TWO_SIDED|95.0|5.45|10.76|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||10.76|5.45|<0.0001
70852006|NCT01798849|141192319|OTHER||Difference in LS means|14.05|||<|0.0001|TWO_SIDED|95.0|10.54|17.57|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||17.57|10.54|<0.0001
70852007|NCT01798849|141192320|OTHER||Difference in LS means|-1.66||||0.202|TWO_SIDED|95.0|-4.24|0.93|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.93|-4.24|0.202
70852008|NCT01798849|141192320|OTHER||Difference in LS means|-2.23||||0.115|TWO_SIDED|95.0|-5.03|0.57|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.57|-5.03|0.115
70852009|NCT01798849|141192320|OTHER||Difference in LS means|-2.75||||0.043|TWO_SIDED|95.0|-5.4|-0.09|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-0.09|-5.40|0.043
70852010|NCT01798849|141192320|OTHER||Difference in LS means|-0.19||||0.901|TWO_SIDED|95.0|-3.22|2.84|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||2.84|-3.22|0.901
70852011|NCT01798849|141192320|OTHER||Mixed effect model|-4.15||||0.002|TWO_SIDED|95.0|-6.74|-1.57|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|||-1.57|-6.74|0.002
70852012|NCT01798849|141192320|OTHER||Difference in LS means|-3.77||||0.008|TWO_SIDED|95.0|-6.48|-1.06|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-1.06|-6.48|0.008
71108804|NCT00328172|141722984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|||<|0.0001||95.0|-1.1|-0.59|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline HbA1c as a linear covariate.||Metformin versus placebo||-0.59|-1.1|<0.0001
71108805|NCT00328172|141722985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.45||||0.7027||95.0|-10.0|15.1|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline FPG as a linear covariate.||Linagliptin 0.5 mg versus placebo||15.1|-10|0.7027
71108806|NCT00328172|141722985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.4||||0.003||95.0|-32.0|-6.6|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline FPG as a linear covariate.||Linagliptin 2.5 mg versus placebo||-6.6|-32|0.003
70935122|NCT04821271|141370948|OTHER|Treatment comparison||||||0.47|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.47
71025587|NCT00601484|141558795|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.68|STANDARD_ERROR_OF_MEAN|6.727|||TWO_SIDED|90.0|-19.954|2.601||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.601|-19.954|
71025588|NCT00601484|141558795|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-17.74|STANDARD_ERROR_OF_MEAN|8.47|||TWO_SIDED|90.0|-31.948|-3.523||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-3.523|-31.948|
71025589|NCT00601484|141558795|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-20.66|STANDARD_ERROR_OF_MEAN|8.138|||TWO_SIDED|90.0|-34.347|-6.971||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-6.971|-34.347|
71025590|NCT00601484|141558795|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-13.58|STANDARD_ERROR_OF_MEAN|9.532|||TWO_SIDED|90.0|-29.612|2.452||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.452|-29.612|
71025591|NCT00601484|141558795|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.75|STANDARD_ERROR_OF_MEAN|8.807|||TWO_SIDED|90.0|-22.58|7.08||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||7.080|-22.580|
71025592|NCT00601484|141558796|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.721|||TWO_SIDED|90.0|-1.768|0.65||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.650|-1.768|
71025593|NCT00601484|141558796|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.21|STANDARD_ERROR_OF_MEAN|0.898|||TWO_SIDED|90.0|-2.723|0.297||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.297|-2.723|
71025594|NCT00601484|141558796|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.47|STANDARD_ERROR_OF_MEAN|1.311|||TWO_SIDED|90.0|-3.682|0.752||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.752|-3.682|
71025595|NCT00601484|141558796|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.54|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|90.0|-1.11|2.198||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.198|-1.110|
71025596|NCT00601484|141558796|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.99|STANDARD_ERROR_OF_MEAN|1.114|||TWO_SIDED|90.0|-2.904|0.922||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.922|-2.904|
71025597|NCT00601484|141558797|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.41|STANDARD_ERROR_OF_MEAN|5.51|||TWO_SIDED|90.0|-13.65|4.826||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||4.826|-13.650|
71025598|NCT00601484|141558797|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.65|STANDARD_ERROR_OF_MEAN|7.041|||TWO_SIDED|90.0|-20.493|3.192||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||3.192|-20.493|
71025599|NCT00601484|141558797|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.72|STANDARD_ERROR_OF_MEAN|10.089|||TWO_SIDED|90.0|-26.775|7.343||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||7.343|-26.775|
71025600|NCT00601484|141558797|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.76|STANDARD_ERROR_OF_MEAN|7.532|||TWO_SIDED|90.0|-8.95|16.465||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||16.465|-8.950|
71025601|NCT00601484|141558797|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.72|STANDARD_ERROR_OF_MEAN|7.906|||TWO_SIDED|90.0|-22.299|4.851||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||4.851|-22.299|
71025602|NCT00601484|141558798|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.609|||TWO_SIDED|90.0|-0.776|1.265||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.265|-0.776|
71108807|NCT00328172|141722985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.3||||0.0418||95.0|-26.0|-0.5|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline FPG as a linear covariate.||Linagliptin 5.0 mg versus placebo||-0.5|-26|0.0418
71108808|NCT00328172|141722985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-34.3|||<|0.0001||95.0|-47.0|-22.0|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline FPG as a linear covariate.||||-22|-47|< 0.0001
71108809|NCT00328172|141722986|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.735||||0.413||95.0|0.464|6.492|||Regression, Logistic|||Linagliptin 0.5 mg versus placebo||6.492|0.464|0.413
71108810|NCT00328172|141722986|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.157||||0.842||95.0|0.275|4.861|||Regression, Logistic|||Linagliptin 2.5 mg versus placebo||4.861|0.275|0.842
71108811|NCT00328172|141722986|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.844||||0.364||95.0|0.492|6.91|||Regression, Logistic|||Linagliptin 5.0 mg versus placebo||6.910|0.492|0.364
71108812|NCT00328172|141722986|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.224||||0.005||95.0|1.648|16.562|||Regression, Logistic|||Metformin versus placebo||16.562|1.648|0.005
71108813|NCT01990742|141722996|OTHER||||||>|0.05|||||||MOnte carlo simulation|||||||>0.05
71108814|NCT01990742|141722997|OTHER||||||>|0.05|||||||Monte carlo simulation|||||||>0.05
71108815|NCT01990742|141722998|OTHER||||||>|0.05|||||||Monte carlo simulation|||||||>0.05
71108816|NCT02261961|141723011|SUPERIORITY||Slope|-0.24275|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
71108817|NCT02261961|141723012|SUPERIORITY||Slope|1.3707|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
71108818|NCT02261961|141723015|SUPERIORITY||Slope|-0.35579|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
71108819|NCT02261961|141723016|SUPERIORITY||Slope|0.004493|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
71108820|NCT02261961|141723017|SUPERIORITY||Slope|0.870653|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
71108821|NCT02261961|141723018|SUPERIORITY||Slope|-0.38664|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
71108822|NCT02261961|141723019|SUPERIORITY||Slope|0.335124|||>|0.05|TWO_SIDED||||||ANCOVA|||Outcomes were compared as percent change from the baseline measure using multiple methods by a blinded statistician. Differences between groups were assessed using ANCOVA, Welch's t-test, and Wilcoxon. No significant differences were found between groups for any outcome regardless of method used.||||>0.05
71108823|NCT02261961|141723021|SUPERIORITY||Slope|0.03145|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
71108824|NCT02261961|141723022|SUPERIORITY||Slope|-0.43902|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
71108825|NCT02261961|141723032|SUPERIORITY||Slope|-0.07603|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
71108826|NCT02261961|141723051|SUPERIORITY||Slope|-0.4745|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
71108827|NCT01365793|141723089|SUPERIORITY|Each statistical test uses stratification to adjust for enrolling hospital, and the arm not being tested (e.g., the test for rapid vs slower rehydration is stratified by 0.45% and 0.9% Saline, and vice versa).||||||0.34||||||The a priori threshold for statistical significance for each of the 2 p-values is 0.025, for an overall significance of 0.50.|Cochran-Mantel-Haenszel|||The study uses a factorial experimental design, and tests two null hypotheses. The first of these hypotheses - the frequency of GCS score declines to \<14 is equal between the Rapid Rehydration and Slower Rehydration groups - is reported here. The analysis of the second hypothesis is reported below.||||0.34
71108828|NCT01365793|141723089|SUPERIORITY|Each statistical test uses stratification to adjust for enrolling hospital, and the arm not being tested (e.g., the test for rapid vs slower rehydration is stratified by 0.45% and 0.9% Saline, and vice versa).||||||0.43||||||The a priori threshold for statistical significance for each of the 2 p-values is 0.025, for an overall significance of 0.50.|Cochran-Mantel-Haenszel|||The study uses a factorial experimental design, and tests the two null hypotheses. The second of these hypotheses - the frequency of GCS score declines to \<14 is equal between the 0.45% Saline group and the 0.90% Saline group - is reported here. The analysis of the first hypothesis is reported above.||||0.43
71108829|NCT01469039|141723107|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
71108830|NCT01469039|141723107|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
71108831|NCT01469039|141723108|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||significant p-value, active vs placebo|Wilcoxon rank sum test based on LOCF|||||||<0.001
71108832|NCT01469039|141723108|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||significant p-value, active vs placebo|Wilcoxon rank sum test based on LOCF|||||||<0.001
71108833|NCT02013609|141723118|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measure (MMRM) with model terms: Baseline, visit, and Baseline by visit interaction||The null hypothesis of zero in mean change from Baseline in MADRS total score at Week 12 was tested at significance level of 0.05. Since this is an exploratory trial, no methods to control type I error rate were performed.||||<0.0001
71108834|NCT02013609|141723119|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12.||||<0.0001
71108835|NCT02013609|141723124|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction.||Statistical analysis at Week 12.||||<0.0001
71108836|NCT02013609|141723125|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12.||||<0.0001
71108837|NCT02013609|141723126|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The p-value is the same for each of single item sub-scores of tasks: work/ school, social life and family life/ home responsibilities|Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12 of single item sub-scores of tasks: work/ school, social life and family life/ home responsibilities||||<0.0001
71108838|NCT02013609|141723127|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12.||||<0.0001
71108839|NCT02013609|141723128|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12||||<0.0001
71108840|NCT02013609|141723129|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12||||<0.0001
71108841|NCT02013609|141723130|SUPERIORITY_OR_OTHER|||||||0.3439|TWO_SIDED||||||t-test, 2 sided|p-value for change from Baseline using t-test.||Statistical analysis at Week 12 for p-inhibition failures (Go cues)||||0.3439
71108842|NCT02013609|141723130|SUPERIORITY_OR_OTHER|||||||0.3385|TWO_SIDED||||||t-test, 2 sided|p-value for change from Baseline using t-test.||Statistical analysis at Week 12 for p-inhibition failures (No-Go cues)||||0.3385
70935123|NCT04821271|141370949|OTHER|Treatment comparison||||||0.14|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.14
71058446|NCT03971474|141622421|SUPERIORITY|||||||0.14|||||||Log Rank|Testing was performed using a weighted log-rank test.||Comparison of IA-PFS between the RP and SOC arms was performed using a standard stratified log-rank test and a weighted log-rank test with weights equal to 1-S(t), where S(t) is the pooled survival estimate at time t (G\[rho=0, gamma=1\]). The weighted test weights later events over earlier events and has more power than the standard log-rank test under a delayed separation in the curves. This analysis reports the weighted log-rank test.||||0.14
71058447|NCT03971474|141622422|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.16|TWO_SIDED|80.0|0.5|1.1||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the PD-L1 \< 1% subgroup.||1.10|0.50|0.16
71058448|NCT03971474|141622422|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.08|TWO_SIDED|80.0|0.45|0.97||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the PD-L1 \>= 1% subgroup.||0.97|0.45|0.08
71058449|NCT03971474|141622422|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.005|TWO_SIDED|80.0|0.28|0.65||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the squamous histology subgroup.||0.65|0.28|0.005
71058450|NCT03971474|141622422|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.43|TWO_SIDED|80.0|0.67|1.35||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the non-squamous histology subgroup.||1.35|0.67|0.43
71058451|NCT03971474|141622423|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.28|TWO_SIDED|80.0|0.58|1.22||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the PD-L1 \< 1% subgroup.||1.22|0.58|0.28
71058452|NCT03971474|141622423|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.07|TWO_SIDED|80.0|0.48|0.95||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the PD-L1 \>= 1% subgroup.||0.95|0.48|0.07
71058453|NCT03971474|141622423|SUPERIORITY||Hazard Ratio (HR)|0.55||||0.02|TWO_SIDED|80.0|0.38|0.8||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the squamous histology subgroup.||0.80|0.38|0.02
71058454|NCT03971474|141622423|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.41|TWO_SIDED|80.0|0.69|1.29||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the non-squamous histology subgroup.||1.29|0.69|0.41
71058455|NCT01937871|141622442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.41|||||TWO_SIDED|95.0|-2.25|-0.57||||||||-0.57|-2.25|
71058456|NCT01937871|141622446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|||||TWO_SIDED|95.0|-1.87|0.18||||||||0.18|-1.87|
71058457|NCT05219448|141622512|SUPERIORITY||Mean Difference (Final Values)|7.4||||0.17|TWO_SIDED|95.0|-3.2|18.0||Unadjusted p value presented. The a priori threshold for statistical significance is 0.05.|Regression, Linear|||Null hypothesis: The change in added sugar intake from baseline to 6-months will be the same when compared to children in the no-treatment control arm (measured through hair biomarker).||18.0|-3.2|0.17
71058458|NCT05219448|141622513|SUPERIORITY||Mean Difference (Final Values)|-5.1||||0.6|TWO_SIDED|95.0|-24.3|14.0||Unadjusted P-value. The threshold for significance is 0.05.|Regression, Linear|||Null hypothesis: The change in added sugar intake from baseline to 6-months will be the same for caregivers in community A arm when compared to caregivers in the no-treatment control arm (measured through hair biomarker).||14.0|-24.3|0.60
71058459|NCT05219448|141622513|SUPERIORITY||Mean Difference (Final Values)|-24.7||||0.013|TWO_SIDED|95.0|-44.1|-5.4||The P-value is unadjusted. The threshold for significance is 0.05.|Regression, Linear|||Null hypothesis: The change in added sugar intake from baseline to 6-months will be the same for caregivers in community B when compared to caregivers in the no-treatment control arm (measured through hair biomarker).||-5.4|-44.1|0.013
71058460|NCT01565356|141622537|SUPERIORITY_OR_OTHER||Kappa statistic|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||Cohen's (simple) kappa statistic||1.00|1.00|
71108843|NCT02013609|141723131|SUPERIORITY_OR_OTHER|||||||0.2052|TWO_SIDED||||||t-test, 2 sided|p-value for change from Baseline using t-test.||Statistical analysis at Week 12 for mean reaction time (Go cues)||||0.2052
71058461|NCT01894087|141622539|SUPERIORITY||Incidence Rate Ratio|0.72|||||TWO_SIDED|95.0|0.59|0.87|||||Numerator is Therapist-led Brief Intervention, Denominator is Enhanced Usual Care only.|Multivariable Poisson regression of outcome of overdose risk behavior sum score at 6 months, adjusting for baseline level of the outcome||0.87|0.59|
71058462|NCT01894087|141622540|SUPERIORITY||Slope|0.1|||||TWO_SIDED|95.0|-0.2|0.4|||||Numerator is the Therapist-Led Brief Intervention and Denominator is Enhanced Usual Care only|Multivariable linear regression of the outcome of standardized sum score of overdose symptom knowledge at 6 months follow-up, adjusted for baseline level of overdose symptom knowledge.||0.40|-0.20|
71058463|NCT01894087|141622541|SUPERIORITY||Incidence Rate Ratio|1.11|||||TWO_SIDED|95.0|0.93|1.33|||||This item was reverse coded; higher scores indicate lower intention to avoid overdose risk (for the strategy of using opioids as prescribed). Numerator was the Therapist-Led Brief Intervention and the denominator was Enhanced Usual Care only.|Multivariable Poisson regression of the outcome of intention to use opioids as prescribed, adjusting for baseline level of the outcome.||1.33|0.93|
70935124|NCT04821271|141370950|OTHER|Treatment comparison||||||0.12|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.12
70935125|NCT04821271|141370951|OTHER|Treatment comparison||||||0.69|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.69
70935126|NCT04821271|141370952|OTHER|Treatment comparison||||||0.73|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.73
70935127|NCT04821271|141370953|OTHER|Treatment comparison||||||0.28|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.28
71058464|NCT01894087|141622541|SUPERIORITY||Incidence Rate Ratio|0.76|||||TWO_SIDED|95.0|0.65|0.9|||||This item was reverse coded; higher scores indicate lower intention to avoid overdose risk (for the strategy of reducing or avoiding opioid use). Numerator was the Therapist-Led Brief Intervention and the denominator was Enhanced Usual Care only.|Multivariable Poisson regression of the outcome of intention to avoid or reduce opioid use, adjusting for baseline level of the outcome.||0.90|0.65|
71058465|NCT01894087|141622541|SUPERIORITY||Incidence Rate Ratio|0.97|||||TWO_SIDED|95.0|0.8|1.19|||||This item was reverse coded; higher scores indicate lower intention to avoid overdose risk (for the strategy of not combining opioids with other drugs). Numerator was Therapist-Led Brief Intervention and denominator was Enhanced Usual Care only.|Multivariable Poisson regression of the outcome of intention to avoid combining opioids with other substances, adjusting for baseline level of the outcome.||1.19|0.80|
71058466|NCT01894087|141622542|SUPERIORITY||Incidence Rate Ratio|0.81|||||TWO_SIDED|95.0|0.7|0.92|||||Numerator is Therapist-Led Brief Intervention, Denominator is Enhanced Usual Care only|Multivariable Poisson regression for the outcome of total COMM score at follow-up, adjusting for baseline level of the outcome||0.92|0.70|
71058467|NCT05534061|141622543|SUPERIORITY||Odds Ratio (OR)|0.98||||0.944|TWO_SIDED|95.0|0.62|1.56||A priori threshold for statistical significance was p\<.05.|Regression, Logistic|A multilevel logistic regression model was specified.|Contingency Management Alone coded as the reference group.|||1.56|0.62|.944
71058468|NCT05534061|141622544|SUPERIORITY||Odds Ratio (OR)|1.01||||0.952|TWO_SIDED|95.0|0.62|1.65||A priori threshold for statistical significance was p\<.05.|Regression, Logistic|A multilevel logistic regression model was specified.|Contingency Management Alone coded as the reference group.|||1.65|0.62|.952
71058469|NCT05534061|141622545|SUPERIORITY||Odds Ratio (OR)|1.16||||0.768|TWO_SIDED|95.0|0.43|3.11||A priori threshold for statistical significance was p\<.05.|Regression, Logistic|A multilevel logistic regression model was specified.|Contingency Management Alone coded as the reference group.|||3.11|0.43|.768
71108844|NCT02013609|141723131|SUPERIORITY_OR_OTHER|||||||0.3224|TWO_SIDED||||||t-test, 2 sided|p-value for change from Baseline using t-test.||Statistical analysis at Week 12 for mean reaction time (No-Go cues)||||0.3224
71108845|NCT02013609|141723132|SUPERIORITY_OR_OTHER|||||||0.3169|TWO_SIDED||||||t-test, 2 sided|p-value for change from Baseline using t-test.||Statistical analysis at Week 12||||0.3169
70935128|NCT05640167|141370970|OTHER|||||||0.015|||||||t-test, 2 sided|Degrees of freedom 17||||||0.015
70935129|NCT05640167|141370971|OTHER|||||||0.114||||||Positive p = 0.114 Health-directed p = 0.028 Skill and Technique p = 0.013 Constructive attitudes p = 0.003 Self-monitoring \& insight p = 0.001 Health service navigation p = 0.077 Social Integration p = 0.126 Emotional well-being p = 0.093|t-test, 2 sided|||||||0.114
70935130|NCT05640167|141370972|OTHER|||||||0.59|||||||t-test, 2 sided|||||||0.59
70935131|NCT05640167|141370973|OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.03
70935132|NCT05640167|141370974|OTHER|||||||0.309|||||||t-test, 2 sided|||||||0.309
70935133|NCT05640167|141370975|OTHER|||||||0.827|||||||t-test, 2 sided|||||||0.827
70935134|NCT01450007|141371012|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|||||||0.001
70935135|NCT01450007|141371013|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|||||||0.001
70935136|NCT01450007|141371014|SUPERIORITY_OR_OTHER|||||||0.76|||||||ANOVA|||||||0.76
70935137|NCT01450007|141371015|SUPERIORITY_OR_OTHER|||||||0.61|||||||Kruskal-Wallis|||Comparison between the 3 groups for pain scores at 24 hours.||||0.61
70935138|NCT01450007|141371015|SUPERIORITY_OR_OTHER|||||||0.13|||||||Kruskal-Wallis|||Comparison between the 3 groups for pain scores at 48 hours.||||0.13
70935139|NCT01450007|141371015|SUPERIORITY_OR_OTHER|||||||0.25|||||||Kruskal-Wallis|||Comparison between the 3 groups for pain scores at 1 week.||||0.25
70935140|NCT01852045|141371021|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.276||0.9949|TWO_SIDED|95.0|-0.549|0.545|||ANCOVA||Least squares estimates and contrast t-test were based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||0.545|-0.549|0.9949
71058470|NCT05534061|141622546|SUPERIORITY||Odds Ratio (OR)|3.96||||0.008|TWO_SIDED|95.0|1.43|10.94||A priori threshold for statistical significance was p\<.05.|Regression, Logistic|A multilevel logistic regression model was specified.|Contingency Management Alone coded as the reference group.|||10.94|1.43|.008
71108846|NCT02013609|141723133|SUPERIORITY_OR_OTHER|||||||0.3352|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 12||||0.3352
70941709|NCT04748445|141383934|OTHER||Slope|0.005103|STANDARD_ERROR_OF_MEAN|2.737||0.8524|TWO_SIDED|90.0|-0.04025|0.05046|||Mixed Models Analysis|||READ\_SNR (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.05046|-0.04025|0.8524
71058471|NCT04138823|141622557|OTHER||Probability of DLT rate in [0.16,0.33)|0.172|||||||||||Bayesian logistic regression model|||Probability of DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
71058472|NCT04138823|141622557|OTHER||Probability of DLT rate in [0.33, 1.00]|0.01||||||||||||||Probability of DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
71058473|NCT04138823|141622557|OTHER||Probabilty of DLT rate in [0.16, 0.33)|0.362||||||||||||||Probability of DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
71058474|NCT04138823|141622557|OTHER||Probability of DLT rate in [0.33, 1.00]|0.046||||||||||||||Probability of DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
71058475|NCT04138823|141622557|OTHER||Probability of DLT rate in [0.16, 0.33)|0.478||||||||||||||"Probability of DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.~The 200 mg BI 891065 BID dose was modelled as equivalent to a 300 mg QD dose in terms of dose-toxicity relationship."||||
71058476|NCT04138823|141622557|OTHER||Probability of DLT rate in [0.33, 1.00]|0.118||||||||||||||"Probability of DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.~The 200 mg BI 891065 BID dose was modelled as equivalent to a 300 mg QD dose in terms of dose-toxicity relationship."||||
71058477|NCT02391987|141622602|SUPERIORITY|||||||0.73|||||||Cochran-Mantel-Haenszel|||||||0.73
71058478|NCT02391987|141622603|SUPERIORITY|||||||0.98|||||||Cochran-Mantel-Haenszel|||||||0.98
71058479|NCT02391987|141622604|SUPERIORITY|||||||0.37|||||||Fisher Exact|||||||0.37
71058480|NCT00207883|141622633|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
71058481|NCT02359994|141622635|NON_INFERIORITY|Non-inferiority was assessed with a pre-specified non-inferiority margin of 10%, such that the endpoint is successfully met if the non-inferiority one-sided p-value is less than 0.025 or, equivalently, if the lower bound of a two-sided 95% confidence interval for the difference between PerClot and Arista hemostasis rates is greater than -10%.|Difference in percentage of participants|-1.4||||0.005|TWO_SIDED|95.0|-7.5|4.8|||Farrington-Manning score test||Directionality for difference in the percentage of participants achieving endpoint: PerClot - Arista|The primary efficacy hypothesis is that the percentage of participants achieving hemostasis of the treated bleeding site at 7 minutes in the overall PerClot group is non-inferior to the percentage of participants achieving hemostasis at 7 minutes in the Arista group, the active control.||4.8|-7.5|0.005
71058482|NCT02359994|141622636|NON_INFERIORITY|Non-inferiority was assessed with a pre-specified non-inferiority margin of 10%, such that the endpoint is successfully met if the non-inferiority one-sided p-value is less than 0.025 or, equivalently, if the lower bound of a two-sided 95% confidence interval for the difference between PerClot and Arista hemostasis rates is greater than -10%.|Difference in Percentage of Participants|4.8|||<|0.001|TWO_SIDED|95.0|-2.4|12.0|||Farrington-Manning score test||Directionality for difference in the percentage of participants achieving endpoint: PerClot - Arista|The secondary efficacy hypothesis is that the percentage of participants achieving hemostasis of the treated bleeding site at 5 minutes in the overall PerClot group is non-inferior to the percentage of participants achieving hemostasis at 5 minutes in the Arista group, the active control.||12.0|-2.4|<0.001
71058483|NCT02213289|141622736|SUPERIORITY|||||||0.0024|||||||One-sided Z-test|This was a test of whether the observed 1-year survival rate was significantly different from historical 50% rate.||||||0.0024
71058484|NCT01866098|141622774|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.83
71058485|NCT01866098|141622775|SUPERIORITY|||||||0.1|||||||Chi-squared|||||||0.10
71058486|NCT01866098|141622776|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.19
71058487|NCT01866098|141622777|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.96
71058488|NCT01866098|141622778|SUPERIORITY|||||||0.92|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.92
71058489|NCT01866098|141622779|SUPERIORITY|||||||0.98|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.98
71058490|NCT01866098|141622780|SUPERIORITY|||||||0.95|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.95
71058491|NCT01866098|141622781|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.43
71058492|NCT03449446|141622797|SUPERIORITY||Difference in percentages|0.6||||0.9449|TWO_SIDED|95.0|-17.6|18.8||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted Mantel-Haenszel (MH) method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||18.8|-17.6|0.9449
71058493|NCT03449446|141622797|SUPERIORITY||Difference in percentages|0.4||||0.9646|TWO_SIDED|95.0|-17.6|18.4||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||18.4|-17.6|0.9646
71108847|NCT02013609|141723134|SUPERIORITY_OR_OTHER|||||||0.3517|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 12 for delay discounting task k value||||0.3517
71108848|NCT02013609|141723134|SUPERIORITY_OR_OTHER|||||||0.3799|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 12 for delay discounting task h value||||0.3799
71025603|NCT00601484|141558798|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.674|||TWO_SIDED|90.0|-1.22|1.044||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.044|-1.220|
71025604|NCT00601484|141558798|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.57|STANDARD_ERROR_OF_MEAN|1.009|||TWO_SIDED|90.0|-1.124|2.269||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.269|-1.124|
71025605|NCT00601484|141558798|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.27|STANDARD_ERROR_OF_MEAN|1.019|||TWO_SIDED|90.0|-1.441|1.988||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.988|-1.441|
71025606|NCT00601484|141558798|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.99|STANDARD_ERROR_OF_MEAN|0.769|||TWO_SIDED|90.0|-0.307|2.283||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.283|-0.307|
71025607|NCT00601484|141558799|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-1.68|||||TWO_SIDED|90.0|-9.05|5.76||||||Week 2: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||5.76|-9.05|
71025608|NCT00601484|141558799|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-2.78|||||TWO_SIDED|90.0|-12.65|4.24||||||Week 4: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||4.24|-12.65|
71025609|NCT00601484|141558799|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|0.04|||||TWO_SIDED|90.0|-8.96|7.9||||||Week 6: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||7.90|-8.96|
71025610|NCT00601484|141558799|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-1.38|||||TWO_SIDED|90.0|-11.57|8.28||||||Week 10: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||8.28|-11.57|
71025611|NCT00601484|141558799|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|3.97|||||TWO_SIDED|90.0|-6.82|13.02||||||Week 16: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||13.02|-6.82|
71025612|NCT00601484|141558800|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|1.01|||TWO_SIDED|90.0|-2.414|0.983||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.983|-2.414|
71025613|NCT00601484|141558800|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.42|STANDARD_ERROR_OF_MEAN|1.169|||TWO_SIDED|90.0|-1.548|2.384||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.384|-1.548|
71025614|NCT00601484|141558800|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.31|STANDARD_ERROR_OF_MEAN|0.821|||TWO_SIDED|90.0|-0.075|2.693||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.693|-0.075|
71025615|NCT00601484|141558800|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|1.093|||TWO_SIDED|90.0|-2.178|1.512||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.512|-2.178|
71058494|NCT03449446|141622797|SUPERIORITY||Difference in percentages|3.7||||0.6219|TWO_SIDED|95.0|-10.9|18.3||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||18.3|-10.9|0.6219
71108849|NCT02013609|141723135|SUPERIORITY_OR_OTHER|||||||0.261|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 12 (AUC for food)||||0.2610
71108850|NCT02013609|141723135|SUPERIORITY_OR_OTHER|||||||0.8138|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 12 (AUC for money)||||0.8138
71108851|NCT02013609|141723136|SUPERIORITY_OR_OTHER|||||||0.8138|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 12 (AUC for money)||||0.8138
71108852|NCT02013609|141723137|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12.||||<0.0001
71108853|NCT00856609|141723138|OTHER||Slope|-624.8||||0.01|TWO_SIDED|95.0|-901.8|-347.8|||ANCOVA|||||-347.8|-901.8|0.01
71108854|NCT00856609|141723139|OTHER||Slope|-24.0||||0.01|TWO_SIDED|95.0|-89.7|41.4|||ANCOVA|||||41.4|-89.7|0.01
71108855|NCT00856609|141723140|OTHER||Slope|-1.48||||0.05|TWO_SIDED|95.0|-3.02|0.05|||ANCOVA|||||0.05|-3.02|0.05
71108856|NCT00783432|141723143|SUPERIORITY_OR_OTHER|||||||0.368||95.0||||This is the Baseline P-Value|ANOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.||||0.368
71108857|NCT00783432|141723143|SUPERIORITY_OR_OTHER|||||||0.327||95.0||||This P-Value if for Month 1|ANCOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.||||0.327
70935141|NCT01852045|141371021|SUPERIORITY||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.321||0.9123|TWO_SIDED|95.0|-0.673|0.602|||ANCOVA||Least squares estimates and contrast t-test were based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||0.602|-0.673|0.9123
71025616|NCT00601484|141558800|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.07|STANDARD_ERROR_OF_MEAN|1.208|||TWO_SIDED|90.0|0.038|4.112||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||4.112|0.038|
71025617|NCT00601484|141558801|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-6.41|||||TWO_SIDED|90.0|-33.33|18.68||||||Week 2: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||18.68|-33.33|
71058495|NCT03449446|141622797|SUPERIORITY||Difference in percentages|8.8||||0.2554|TWO_SIDED|95.0|-6.4|24.1||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||24.1|-6.4|0.2554
71058496|NCT03449446|141622797|SUPERIORITY||Difference in percentages|10.8||||0.1658|TWO_SIDED|95.0|-4.5|26.1||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||26.1|-4.5|0.1658
71058497|NCT03449446|141622797|SUPERIORITY||Difference in percentages|3.2||||0.6963|TWO_SIDED|95.0|-12.9|19.4||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||19.4|-12.9|0.6963
71058498|NCT03449446|141622797|SUPERIORITY||Difference in percentages|10.0||||0.2441|TWO_SIDED|95.0|-6.8|26.8||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||26.8|-6.8|0.2441
71058499|NCT03449446|141622797|SUPERIORITY||Difference in percentages|5.2||||0.5229|TWO_SIDED|95.0|-10.7|21.0||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||21.0|-10.7|0.5229
71058500|NCT03449446|141622797|SUPERIORITY||Difference in percentages|10.4||||0.2149|TWO_SIDED|95.0|-6.0|26.9||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||26.9|-6.0|0.2149
71058501|NCT01579747|141622804|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Normality of distribution was assessed with the Shapiro-Wilk test. For normally-distributed continuous variables, the groups' distributions were described as means and standard deviations (SD). Student's t-test was used to compare groups in these cases with statistically-significant differences summarized using 95% confidence intervals as appropriate. For all comparisons, two-tailed p\<0.05 was considered statistically significant.||||<0.05
71058502|NCT04182334|141622805|SUPERIORITY|||||||0.775|||||||Mixed Models Analysis|||||||0.775
71058503|NCT04182334|141622806|SUPERIORITY|||||||0.995|||||||Mixed Models Analysis|||||||0.995
71058504|NCT04182334|141622807|SUPERIORITY|||||||0.674|||||||Mixed Models Analysis|||||||0.674
71058505|NCT04182334|141622808|SUPERIORITY|||||||0.326|||||||Mixed Models Analysis|||||||0.326
71058506|NCT04182334|141622809|SUPERIORITY|||||||0.463|||||||Wilcoxon (Mann-Whitney)|||||||0.463
71058507|NCT04182334|141622810|SUPERIORITY|||||||0.449|||||||Wilcoxon (Mann-Whitney)|||||||0.449
70935142|NCT01852045|141371023|SUPERIORITY||Least Squares Mean Difference|12.97|STANDARD_ERROR_OF_MEAN|19.694||0.5117|TWO_SIDED|95.0|-26.12|52.064|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||52.064|-26.120|0.5117
70935143|NCT01852045|141371023|SUPERIORITY||Least Squares Mean Difference|65.57|STANDARD_ERROR_OF_MEAN|23.101||0.0055|TWO_SIDED|95.0|19.711|111.421|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||111.421|19.711|0.0055
71058508|NCT04182334|141622811|SUPERIORITY|||||||0.505|||||||Wilcoxon (Mann-Whitney)|||||||0.505
71058509|NCT04182334|141622812|SUPERIORITY|||||||0.612|||||||Wilcoxon (Mann-Whitney)|||||||0.612
71058510|NCT04182334|141622813|SUPERIORITY|||||||0.058|||||||Wilcoxon (Mann-Whitney)|||||||0.058
71058511|NCT04182334|141622814|SUPERIORITY|||||||0.196|||||||Wilcoxon (Mann-Whitney)|||||||0.196
71058512|NCT01950390|141622824|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.383|ONE_SIDED|90.0||1.23||One-sided|Log Rank|Stratification factors of BRAF mutation status (wild type/mutation) and prior therapy (yes/no) were used in the stratified analysis|One-sided 90% Repeated Confidence Interval for Hazard Ratio with Arm A as Reference|||1.23||0.383
71058513|NCT01950390|141622825|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.358|TWO_SIDED|95.0|0.61|1.2||Two-sided|Log Rank|Stratified Log rank test||||1.20|0.61|0.358
71058514|NCT01950390|141622826|SUPERIORITY|||||||0.482||||||Two-sided|Chi-squared|||||||0.482
71058515|NCT01950390|141622828|SUPERIORITY|||||||0.937||||||Two-sided|Chi-squared|||||||0.937
70935144|NCT01852045|141371025|SUPERIORITY||Least Squares Mean Difference|-13.49|STANDARD_ERROR_OF_MEAN|19.673||0.4948|TWO_SIDED|95.0|-52.605|25.626|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||25.626|-52.605|0.4948
71108858|NCT00783432|141723143|SUPERIORITY_OR_OTHER|||||||0.991||95.0||||This P-Value is for Month 3|ANCOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.||||0.991
71108859|NCT00783432|141723143|SUPERIORITY_OR_OTHER|||||||0.168||95.0||||This P-Value is for Month 6|ANCOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.||||0.168
71108860|NCT00783432|141723143|SUPERIORITY_OR_OTHER|||||||0.319||95.0||||This P-Value is for Month 9|ANCOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.||||0.319
71108861|NCT00783432|141723143|SUPERIORITY_OR_OTHER|||||||0.725||||||This P-Value is for Month 12/ET|ANCOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.||||0.725
71108862|NCT03273907|141723144|SUPERIORITY|The primary null hypothesis tested was that the observed rate of clinically relevant complications associated with CyPass Micro-Stent placement and stability is greater than or equal to the performance target rate of 7.00 percent.||||||0.187|||||||Exact one-sided binomial test|P-value is provided from exact one-sided binomial test with type I error 0.05 comparing CyPass System with performance criterion of 7.00 percent.||||||0.1870
71108863|NCT02581891|141723152|NON_INFERIORITY|The non-inferiority margin is set to 5 letters.|LS mean difference|-2.0199|STANDARD_ERROR_OF_MEAN|1.3833||0.0162|TWO_SIDED|95.0|-4.747|0.7073|||ANCOVA|||||0.7073|-4.7470|0.0162
71108864|NCT04828707|141723161|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||"The Intent-To-Treat (ITT) dataset was used for primary outcome. To overcome impact of missing data, statistical analysis was conducted using the Last Observation Carried Forward (LOCF) as an imputation method.~The data of each variable collected from the daily diary was normalized to 28 days for every period (weeks 1-4, weeks 5-8, and weeks 9-12).~Participants' data who entered the treatment phase but dropped out during weeks 5-8 were carried forward and analyzed as their data at weeks 9-12."||||<0.05
70935145|NCT01852045|141371025|SUPERIORITY||Least Squares Mean Difference|1.49|STANDARD_ERROR_OF_MEAN|22.382||0.9471|TWO_SIDED|95.0|-43.012|45.991|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||45.991|-43.012|0.9471
70935146|NCT01852045|141371026|SUPERIORITY||Relative Risk|0.7||||0.2027|TWO_SIDED|95.0|0.45|1.14||P-values for pairwise comparisons are obtained from 2-sided CMH test, stratified by age (\<12 years or \>=12 years), baseline daytime urinary incontinence episodes (\<=6 or \>6) and anticholinergic therapy (yes/no).|Cochran-Mantel-Haenszel|||Week 6||1.14|0.45|0.2027
71108865|NCT00523978|141723185|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||The null hypothesis is the success rate in experimental group is less than and equal to the one in control group. This comparison of the rates was performed using a 2-sided Fisher's Exact. A sample size of 240(160 experimental and 80 control) is required to provide 80% power to detect the treatment difference using a 2-sided (alpha = 0.05)Fisher's Exact Test of binomial proportions assuming the success rate was 40% for control and 60% for treatment.||||<0.0001
71108866|NCT00523978|141723186|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin was selected based on literature review.|||||<|0.001|||||||t-test, 1 sided|||The null hypothesis is the proportion of subjects free from MAFE in the experimental group is inferior to that in the control group using 10% non-inferiority margin.A sample size of 160 evaluable cryoablation and 80 control subjects (one-sided α = 0.05, 2:1 randomization) was required to provide 80% power assuming the rate of free from MAFE at 12 months 80.5 and 77% in experimental and control groups respectively .||||<0.001
71108867|NCT00523978|141723187|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||The test hypothesis is UCBExperimental\_CPE ≥ 14.8% vs UCBExperimental\_CPE \< 14.8%.The performance goal 14.8% was chosen based on a review of SSEDs for similar types of ablation trials.The expected rate for CPEs in a well-monitored trial of left atrial RF ablation for AF was estimated to be 10% (corresponding to a CPE-free rate of 90%).In a trial with 160 subject, the resulting one-sided 95% upper confidence bound would be 14.8%.||||<0.001
71108868|NCT00696878|141723188|SUPERIORITY_OR_OTHER_LEGACY||Percentage with immunogenicity|0.0|||||ONE_SIDED|95.0||0.4|||||Provided limit is upper 1-sided 95% confidence limit for study population for percentage of participants with clinically relevant immunogenicity, after Cycle 1|During sample size determination, the upper limit of the one-sided 95% confidence interval for the population incidence of immunogenicity, if no immunogenicity is observed, was calculated. If no immunogenicity is observed in the projected 150 participants who receive corifollitropin alfa during 3 COS cycles, then the upper limit for the population is 2%. For the projected 300 participants who receive corifollitropin alfa during 2 COS cycles, the upper limit for the population is 1%.||0.4||
71117629|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
70935147|NCT01852045|141371026|SUPERIORITY||Relative Risk|0.8||||0.1564|TWO_SIDED|95.0|0.4|1.21||P-values for pairwise comparisons are obtained from a 2-sided CMH test, stratified by age (\< 12 years or \>= 12 years), baseline daytime urinary incontinence episodes (\<= 6 or \> 6) and anticholinergic therapy (yes/no).|Cochran-Mantel-Haenszel|||Week 6||1.21|0.40|0.1564
71108869|NCT00696878|141723188|SUPERIORITY_OR_OTHER_LEGACY||Percentage with immunogenicity|0.0|||||ONE_SIDED|95.0||0.8|||||Provided limit is upper 1-sided 95% confidence limit for study population for percentage of participants with clinically relevant immunogenicity, after Cycle 2|During sample size determination, the upper limit of the one-sided 95% confidence interval for the population incidence of immunogenicity, if no immunogenicity is observed, was calculated. If no immunogenicity is observed in the projected 150 participants who receive corifollitropin alfa during 3 COS cycles, then the upper limit for the population is 2%. For the projected 300 participants who receive corifollitropin alfa during 2 COS cycles, the upper limit for the population is 1%.||0.8||
71108870|NCT00696878|141723188|SUPERIORITY_OR_OTHER_LEGACY||Percentage with immunogenicity|0.0|||||ONE_SIDED|95.0||1.5|||||Provided limit is upper 1-sided 95% confidence limit for study population for percentage of participants with clinically relevant immunogenicity, after Cycle 3|During sample size determination, the upper limit of the one-sided 95% confidence interval for the population incidence of immunogenicity, if no immunogenicity is observed, was calculated. If no immunogenicity is observed in the projected 150 participants who receive corifollitropin alfa during 3 COS cycles, then the upper limit for the population is 2%. For the projected 300 participants who receive corifollitropin alfa during 2 COS cycles, the upper limit for the population is 1%.||1.5||
70935148|NCT01852045|141371027|SUPERIORITY||Least Squares Mean Difference|-4.49|STANDARD_ERROR_OF_MEAN|7.488||0.5524|TWO_SIDED|95.0|-19.648|10.669|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||10.669|-19.648|0.5524
70935149|NCT01852045|141371027|SUPERIORITY||Least Squares Mean Difference|2.18|STANDARD_ERROR_OF_MEAN|10.181||0.8313|TWO_SIDED|95.0|-18.427|22.795|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||22.795|-18.427|0.8313
70935150|NCT01852045|141371028|SUPERIORITY||Least Squares Mean Difference|-7.21|STANDARD_ERROR_OF_MEAN|5.253||0.1737|TWO_SIDED|95.0|-17.653|3.238|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||3.238|-17.653|0.1737
70935151|NCT01852045|141371028|SUPERIORITY||Least Squares Mean Difference|-14.43|STANDARD_ERROR_OF_MEAN|5.85||0.0157|TWO_SIDED|95.0|-26.061|-2.793|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||-2.793|-26.061|0.0157
71025618|NCT00601484|141558801|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|15.83|||||TWO_SIDED|90.0|-14.12|41.18||||||Week 4: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||41.18|-14.12|
71025619|NCT00601484|141558801|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|19.17|||||TWO_SIDED|90.0|0.0|38.1||||||Week 6: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||38.10|0.00|
71108871|NCT00940602|141723259|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|0.636||||0.015|TWO_SIDED|95.0|0.42|0.96||Exploratory p-value is one tailed and is based on the stratified log-rank test.|Regression, Cox||95% CI was based on a Wald test from Cox model|||0.96|0.42|0.015
71108872|NCT00940602|141723260|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|12.0|||||TWO_SIDED|95.0|-1.8|25.7||||||||25.7|-1.8|
71108873|NCT00940602|141723261|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|0.832||||0.2|TWO_SIDED|95.0|0.54|1.28|||Regression, Cox||95% CI was based on a Wald test from Cox model.|||1.28|0.54|0.200
70852013|NCT01798849|141192320|OTHER||Difference in LS means|-1.77||||0.201|TWO_SIDED|95.0|-4.51|0.98|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.98|-4.51|0.201
70935152|NCT00487240|141371034|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority limit of 0.4% using the upper limit of a two-sided test at a significance level of 0.05 with 90% power assuming a 1.1 Standard Deviations (SD)|Mean Difference (Net)|-0.1||||0.332||95.0|-0.29|0.1|||ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Country.|Least Squares Mean Difference = Insulin Lispro Protamine Suspension minus Detemir.|Hypothesis: basal analog insulin lispro protamine suspension (ILPS), is inferior to basal analog insulin detemir, as measured by change in HbA1c from baseline to endpoint.||0.10|-0.29|0.332
70935153|NCT00487240|141371035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.718||95.0|-0.22|0.15||P-value for 8 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country.|Least Squares Mean Difference=Insulin Lispro Protamine Suspension minus Detemir.|||0.15|-0.22|0.718
70935154|NCT00487240|141371035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.187||95.0|-0.34|0.07||P-value for 16 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|Least Squares Mean Difference = Insulin Lispro Protamine Suspension minus Detemir.|||0.07|-0.34|0.187
70935155|NCT00487240|141371035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.704||95.0|-0.25|0.17||P-value for 24 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|Least Squares Mean Difference = Insulin Lispro Protamine Suspension minus Detemir.|||0.17|-0.25|0.704
70935156|NCT00487240|141371035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.599||95.0|-0.27|0.15||P-value for 32 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|Least Squares Mean Difference = Insulin Lispro Protamine Suspension minus Detemir.|||0.15|-0.27|0.599
70935157|NCT00487240|141371036|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for With HbA1c ≤7.0%.|Fisher Exact|||||||1.000
70935158|NCT00487240|141371036|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for With HbA1c \<7.0%|Fisher Exact|||||||1.000
70935159|NCT00487240|141371036|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||P-value for With HbA1c ≤6.5%|Fisher Exact|||||||0.722
71108874|NCT00940602|141723262|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|1.4|||||TWO_SIDED|95.0|-5.3|8.1||||||||8.1|-5.3|
70935160|NCT00487240|141371036|SUPERIORITY_OR_OTHER|||||||0.699||95.0||||P-value for With HbA1c \<6.5%|Fisher Exact|||||||0.699
70935161|NCT00487240|141371037|SUPERIORITY_OR_OTHER|||||||0.259||95.0||||P-value for Daily Mean 7-Point SMBG.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.259
71108875|NCT00940602|141723263|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|-0.3|||||TWO_SIDED|95.0|-12.0|11.4||||||||11.4|-12.0|
70935162|NCT00487240|141371037|SUPERIORITY_OR_OTHER|||||||0.468||95.0||||P-value for Daily Mean Pre-Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.468
70935163|NCT00487240|141371037|SUPERIORITY_OR_OTHER|||||||0.395||95.0||||P-value for Daily Mean Postprandial Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.395
70935164|NCT00487240|141371037|SUPERIORITY_OR_OTHER|||||||0.414||95.0||||P-value for Daily Mean Morning and Evening Pre-Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.414
71108876|NCT00940602|141723264|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|0.725||||0.184|TWO_SIDED|95.0|0.36|1.46|||Regression, Cox||95% CI was based on a Wald test from Cox model.|||1.46|0.36|0.184
71108877|NCT00940602|141723265|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|0.195|||<|0.001|TWO_SIDED|95.0|0.11|0.36|||Regression, Cox||95% CI was based on a Wald test from Cox model.|||0.36|0.11|<.001
70852014|NCT01798849|141192320|OTHER||Difference in LS means|-4.74||||0.001|TWO_SIDED|95.0|-7.37|-2.11|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-2.11|-7.37|0.001
71108878|NCT00940602|141723266|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|0.871||||0.303|TWO_SIDED|95.0|0.52|1.46|||Regression, Cox||95% CI was based on a Wald test from Cox model.|||1.46|0.52|0.303
71108879|NCT00940602|141723267|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|1.072||||0.389|TWO_SIDED|95.0|0.66|1.75|||Regression, Cox||95% CI was based on a Wald test from Cox model.|||1.75|0.66|0.389
71108880|NCT00940602|141723269|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|1.5|||||TWO_SIDED|95.0|-5.2|8.1||||||||8.1|-5.2|
71108881|NCT00940602|141723270|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|0.7|||||TWO_SIDED|95.0|-1.6|3.0||||||||3.0|-1.6|
71108882|NCT00940602|141723271|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|1.4|||||TWO_SIDED|95.0|-11.9|14.6||||||||14.6|-11.9|
71108883|NCT00940602|141723272|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|-9.6|||||TWO_SIDED|95.0|-20.8|1.6||||||||1.6|-20.8|
71108884|NCT00940602|141723273|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|0.797||||0.232|TWO_SIDED|95.0|0.43|1.46|||Regression, Cox||95% CI was based on a Wald test from Cox model.|||1.46|0.43|0.232
71108885|NCT01120405|141723280|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of xenon over sevoflurane is accepted if the upper bound of the two-sided 95% CI around the estimated difference is below the prespecified non-inferiority margin of 10%.|Difference of proportion|0.19||||0.0052|TWO_SIDED|95.0|-6.7|7.07|||Difference of proportion|||"The percentage of patients with MN during the 3 postoperative days in the sevoflurane group and in the xenon group was expected to be 20%. The margin of non-inferiority was 10%. Thus the sample size to prove non-inferiority was 252 patients per group with α = 0.025, a power of 0.80 and the following hypotheses: H0: Px-Pc ≥ 10%; H1: Px-Pc \< 10%.~As it was expected that approximately 15% of patients would be non-evaluable, a total of 600 patients were included."||7.07|-6.70|0.0052
71108886|NCT01120405|141723281|SUPERIORITY_OR_OTHER||Difference of proportion|0.68||||0.7715|TWO_SIDED|95.0|-3.9|5.25|||Difference of proportion|||||5.25|-3.90|0.7715
71108887|NCT01120405|141723282|SUPERIORITY_OR_OTHER||Difference of proportion|0.68||||0.4763|TWO_SIDED|95.0|-1.19|2.54|||Difference of proportion|||||2.54|-1.19|0.4763
71108888|NCT01120405|141723283|SUPERIORITY_OR_OTHER||Difference of proportion|-0.34||||0.6533|TWO_SIDED|95.0|-1.82|1.14|||Difference of proportion|||||1.14|-1.82|0.6533
71108889|NCT01120405|141723284|SUPERIORITY_OR_OTHER||Difference of proportion|0.68||||0.1559|TWO_SIDED|95.0|-0.26|1.61|||Difference of proportion|||||1.61|-0.26|0.1559
71108890|NCT01120405|141723286|SUPERIORITY_OR_OTHER||Difference of proportion|1.69||||0.6056|TWO_SIDED|95.0|-4.74|8.13|||Difference of proportion|||||8.13|-4.74|0.6056
71108891|NCT00508482|141723309|SUPERIORITY_OR_OTHER|||||||0.238|||||||Kruskal-Wallis|||Comparison among three groups over 4 weeks of treatment||||0.238
71108892|NCT00508482|141723309|SUPERIORITY_OR_OTHER|||||||0.004|||||||Kruskal-Wallis|||Comparison among three groups at the 4th week of follow-up||||0.004
71108893|NCT00508482|141723309|SUPERIORITY_OR_OTHER|||||||0.277|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 4th week of follow-up||||0.277
71108894|NCT00508482|141723309|SUPERIORITY_OR_OTHER|||||||0.001|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 4th week of follow-up||||0.001
71108895|NCT00508482|141723309|SUPERIORITY_OR_OTHER|||||||0.055|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 4th week of follow-up||||0.055
71108896|NCT00508482|141723309|SUPERIORITY_OR_OTHER|||||||0.001|||||||Kruskal-Wallis|||Comparison among three groups at the 12th week of follow-up||||0.001
71108897|NCT00508482|141723309|SUPERIORITY_OR_OTHER|||||||0.33|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 12th week of follow-up||||0.330
71108898|NCT00508482|141723309|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 12th week of follow-up||||<0.001
71108899|NCT00508482|141723309|SUPERIORITY_OR_OTHER|||||||0.018|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 12th week of follow-up||||0.018
71025620|NCT00601484|141558801|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-0.71|||||TWO_SIDED|90.0|-30.95|32.73||||||Week 10: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||32.73|-30.95|
71025621|NCT00601484|141558801|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|34.89|||||TWO_SIDED|90.0|-4.57|70.0||||||Week 16: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||70.00|-4.57|
71025622|NCT00601484|141558802|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.529|0.61||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.610|-0.529|
71025623|NCT00601484|141558802|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.334|||TWO_SIDED|90.0|-1.077|0.043||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.043|-1.077|
70852015|NCT01798849|141192321|OTHER||Difference in LS means|-2.53||||0.042|TWO_SIDED|95.0|-4.97|-0.1|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-0.10|-4.97|0.042
71025624|NCT00601484|141558802|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.366|||TWO_SIDED|90.0|-0.835|0.396||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.396|-0.835|
71025625|NCT00601484|141558802|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.294|||TWO_SIDED|90.0|-0.718|0.273||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.273|-0.718|
71025626|NCT00601484|141558802|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.442|||TWO_SIDED|90.0|-1.044|0.445||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.445|-1.044|
70852016|NCT01798849|141192321|OTHER||Difference in LS means|-3.29||||0.01|TWO_SIDED|95.0|-5.71|-0.88|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-0.88|-5.71|0.010
70852017|NCT01798849|141192321|OTHER||Difference in LS means|-6.42|||<|0.0001|TWO_SIDED|95.0|-8.94|-3.89|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-3.89|-8.94|<0.0001
70852018|NCT01798849|141192321|OTHER||Difference in LS means|-8.28|||<|0.0001|TWO_SIDED|95.0|-11.32|-5.25|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-5.25|-11.32|<0.0001
70852019|NCT01798849|141192322|OTHER||Difference in LS means|0.54||||0.638|TWO_SIDED|95.0|-1.8|2.87|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||2.87|-1.80|0.638
70852020|NCT01798849|141192322|OTHER||Difference in LS means|0.72||||0.616|TWO_SIDED|95.0|-2.2|3.63|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||3.63|-2.20|0.616
70935165|NCT00487240|141371037|SUPERIORITY_OR_OTHER|||||||0.275||95.0||||P-value for Actual Morning Pre-Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.275
71025627|NCT00601484|141558803|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-1.24|||||TWO_SIDED|90.0|-27.56|5.37||||||Week 2: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||5.37|-27.56|
71025628|NCT00601484|141558803|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-22.43|||||TWO_SIDED|90.0|-56.39|0.0||||||Week 4: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||0.00|-56.39|
71025629|NCT00601484|141558803|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-16.0|||||TWO_SIDED|90.0|-40.44|0.0||||||Week 6: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||0.00|-40.44|
71025630|NCT00601484|141558803|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-14.18|||||TWO_SIDED|90.0|-50.71|0.0||||||Week 10: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||0.00|-50.71|
71058516|NCT00486525|141622944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.075|STANDARD_ERROR_OF_MEAN|0.058||0.2|TWO_SIDED|95.0|-0.19|0.039|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||0.039|-0.19|0.20
70935166|NCT00487240|141371037|SUPERIORITY_OR_OTHER|||||||0.611||95.0||||P-value for Actual Morning Postprandial Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.611
70935167|NCT00487240|141371037|SUPERIORITY_OR_OTHER|||||||0.763||95.0||||P-value for Actual Midday Pre-Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.763
70935168|NCT00487240|141371037|SUPERIORITY_OR_OTHER|||||||0.977||95.0||||P-value for Actual Midday Postprandial Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.977
70935169|NCT00487240|141371037|SUPERIORITY_OR_OTHER|||||||0.586||95.0||||P-value for Actual Evening Pre-Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.586
71058517|NCT00486525|141622944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.06||0.027|TWO_SIDED|95.0|-0.25|-0.015|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||-0.015|-0.25|0.027
71058518|NCT00486525|141622944|SUPERIORITY_OR_OTHER||Slope|-0.021|STANDARD_ERROR_OF_MEAN|0.02||0.28|TWO_SIDED|95.0|-0.06|0.018|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of ln (TNF-a) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||0.018|-0.060|0.28
71058519|NCT00486525|141622944|SUPERIORITY_OR_OTHER||Slope|-0.038|STANDARD_ERROR_OF_MEAN|0.02||0.063|TWO_SIDED|95.0|-0.079|0.0021|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of ln (TNF-a) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||0.0021|-0.079|0.063
71058520|NCT00486525|141622945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.079|STANDARD_ERROR_OF_MEAN|0.062||0.2|TWO_SIDED|95.0|-0.2|-0.042|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||-0.042|-0.2|0.2
71058521|NCT00486525|141622945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.064||0.015|TWO_SIDED|95.0|-0.28|-0.031|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||-0.031|-0.28|0.015
71058522|NCT00486525|141622945|SUPERIORITY_OR_OTHER||Slope|-0.022|STANDARD_ERROR_OF_MEAN|0.021||0.3|TWO_SIDED|95.0|-0.063|0.019|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of ln (IL-6) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||0.019|-0.063|0.3
71058523|NCT00486525|141622945|SUPERIORITY_OR_OTHER||Slope|-0.056|STANDARD_ERROR_OF_MEAN|0.022||0.01|TWO_SIDED|95.0|-0.098|-0.013|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of ln (IL-6) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||-0.013|-0.098|0.01
70852021|NCT01798849|141192322|OTHER||Difference in LS means|2.33||||0.041|TWO_SIDED|95.0|0.11|4.56|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||4.56|0.11|0.041
70935170|NCT00487240|141371037|SUPERIORITY_OR_OTHER|||||||0.093||95.0||||P-value for Actual Evening Postprandial Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.093
70935171|NCT00487240|141371037|SUPERIORITY_OR_OTHER|||||||0.516||95.0||||P-value for Actual 0300 Hours|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.516
70935172|NCT00487240|141371037|SUPERIORITY_OR_OTHER|||||||0.576||95.0||||P-value for Actual Morning SMBG Excursion|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.576
70935173|NCT00487240|141371037|SUPERIORITY_OR_OTHER|||||||0.876||95.0||||P-value for Midday SMBG Excursion|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.876
70935174|NCT00487240|141371037|SUPERIORITY_OR_OTHER|||||||0.261||95.0||||P-value for Evening SMBG Excursion|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.261
70935175|NCT00487240|141371037|SUPERIORITY_OR_OTHER|||||||0.567||95.0||||P-value for Daily Mean SMBG Excursion|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.567
70935176|NCT00487240|141371038|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 0.8 mmol/L was chosen to prove noninferiority of ILPS to detemir.|Mean Difference (Net)|0.36||||||95.0|-0.03|0.75|||||Least Squares Mean difference = Insulin Lispro Protamine Suspension - Detemir|If the primary analysis achieves statistical significance at a 0.05 level (that is, the null hypothesis for the primary analysis \[primary outcome measure\] is rejected), then the first secondary hypothesis (glycemic variability) is tested at an error rate of 0.05.||0.75|-0.03|
70935177|NCT00487240|141371038|SUPERIORITY_OR_OTHER|||||||0.132||95.0||||P-value for M-Value|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.132
70935178|NCT00487240|141371038|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||P-value for MODD|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.179
70935179|NCT00487240|141371039|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||P-value for Endpoint Hypoglycemic Episodes|Fisher Exact|||||||0.737
70935180|NCT00487240|141371039|SUPERIORITY_OR_OTHER|||||||0.724||95.0||||P-value for Overall Hypoglycemic Episodes|Fisher Exact|||||||0.724
71025631|NCT00601484|141558803|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-8.61|||||TWO_SIDED|90.0|-36.87|4.64||||||Week 16: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||4.64|-36.87|
71025632|NCT00601484|141558804|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.1|STANDARD_ERROR_OF_MEAN|12.495|||TWO_SIDED|90.0|-15.852|26.044||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||26.044|-15.852|
71025633|NCT00601484|141558804|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.27|STANDARD_ERROR_OF_MEAN|12.802|||TWO_SIDED|90.0|-17.216|25.764||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||25.764|-17.216|
71025634|NCT00601484|141558804|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.81|STANDARD_ERROR_OF_MEAN|13.741|||TWO_SIDED|90.0|-25.917|20.307||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||20.307|-25.917|
71025635|NCT00601484|141558804|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.73|STANDARD_ERROR_OF_MEAN|12.416|||TWO_SIDED|90.0|-21.626|20.162||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||20.162|-21.626|
71025636|NCT00601484|141558804|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|10.51|STANDARD_ERROR_OF_MEAN|14.469|||TWO_SIDED|90.0|-13.858|34.868||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||34.868|-13.858|
71025637|NCT00601484|141558805|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.63|STANDARD_ERROR_OF_MEAN|6.968|||TWO_SIDED|90.0|-8.049|15.316||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||15.316|-8.049|
71025638|NCT00601484|141558805|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.19|STANDARD_ERROR_OF_MEAN|7.353|||TWO_SIDED|90.0|-9.153|15.533||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||15.533|-9.153|
71025639|NCT00601484|141558805|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.94|STANDARD_ERROR_OF_MEAN|7.651|||TWO_SIDED|90.0|-13.806|11.932||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||11.932|-13.806|
71058524|NCT00486525|141622946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.33|TWO_SIDED|95.0|-0.31|0.11|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||0.11|-0.31|0.33
71058525|NCT00486525|141622946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.11||0.037|TWO_SIDED|95.0|-0.44|-0.014|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||-0.014|-0.44|0.037
71058526|NCT00486525|141622946|SUPERIORITY_OR_OTHER||Slope|-0.034|STANDARD_ERROR_OF_MEAN|0.0235||0.33|TWO_SIDED|95.0|-0.1|0.035|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of ln (IL-1b) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||0.035|-0.10|0.33
71058527|NCT00486525|141622946|SUPERIORITY_OR_OTHER||Slope|-0.078|STANDARD_ERROR_OF_MEAN|0.036||0.03|TWO_SIDED|95.0|-0.15|-0.0074|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of ln (IL-1b) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||-0.0074|-0.15|0.03
71108900|NCT00508482|141723310|SUPERIORITY_OR_OTHER|||||||0.573|||||||ANOVA|||||||0.573
70852022|NCT01798849|141192322|OTHER||Difference in LS means|9.14|||<|0.0001|TWO_SIDED|95.0|6.98|11.3|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||11.30|6.98|<0.0001
71025640|NCT00601484|141558805|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.79|STANDARD_ERROR_OF_MEAN|7.543|||TWO_SIDED|90.0|-5.901|19.486||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||19.486|-5.901|
71108901|NCT00508482|141723311|SUPERIORITY_OR_OTHER|||||||0.271|||||||Kruskal-Wallis|||||||0.271
71108902|NCT00508482|141723312|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71108903|NCT00508482|141723312|SUPERIORITY_OR_OTHER|||||||0.58|||||||Least-Significant Difference|||||||0.580
70935181|NCT00487240|141371039|SUPERIORITY_OR_OTHER|||||||0.157||95.0||||P-value for Endpoint Nocturnal Hypoglycemic Episodes|Fisher Exact|||||||0.157
70935182|NCT00487240|141371039|SUPERIORITY_OR_OTHER|||||||0.287||95.0||||P-value for Overall Nocturnal Episodes|Fisher Exact|||||||0.287
70935183|NCT00487240|141371039|SUPERIORITY_OR_OTHER|||||||0.664||95.0||||P-value for Endpoint Non-Nocturnal Hypoglycemic Episodes|Fisher Exact|||||||0.664
71025641|NCT00601484|141558805|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.77|STANDARD_ERROR_OF_MEAN|8.31|||TWO_SIDED|90.0|-9.221|18.765||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||18.765|-9.221|
71025642|NCT00601484|141558806|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.86|STANDARD_ERROR_OF_MEAN|0.407|||TWO_SIDED|90.0|-1.546|-0.182||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.182|-1.546|
71025643|NCT00601484|141558806|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.38|STANDARD_ERROR_OF_MEAN|0.484|||TWO_SIDED|90.0|-2.196|-0.57||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.570|-2.196|
71025644|NCT00601484|141558806|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|90.0|-2.204|-0.388||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.388|-2.204|
71025645|NCT00601484|141558806|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.553|||TWO_SIDED|90.0|-2.032|-0.172||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.172|-2.032|
71025646|NCT00601484|141558806|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.02|STANDARD_ERROR_OF_MEAN|0.512|||TWO_SIDED|90.0|-1.878|-0.152||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.152|-1.878|
71025647|NCT00601484|141558807|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-16.24|STANDARD_ERROR_OF_MEAN|8.064|||TWO_SIDED|90.0|-29.757|-2.718||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-2.718|-29.757|
71025648|NCT00601484|141558807|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-27.96|STANDARD_ERROR_OF_MEAN|10.059|||TWO_SIDED|90.0|-44.846|-11.075||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-11.075|-44.846|
71025649|NCT00601484|141558807|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-25.72|STANDARD_ERROR_OF_MEAN|11.508|||TWO_SIDED|90.0|-45.079|-6.369||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-6.369|-45.079|
71025650|NCT00601484|141558807|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-19.56|STANDARD_ERROR_OF_MEAN|12.157|||TWO_SIDED|90.0|-40.017|0.902||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.902|-40.017|
71025651|NCT00601484|141558807|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-21.9|STANDARD_ERROR_OF_MEAN|11.124|||TWO_SIDED|90.0|-40.633|-3.171||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-3.171|-40.633|
71025652|NCT00601484|141558808|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|90.0|-2.942|-0.057||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.057|-2.942|
71025653|NCT00601484|141558808|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.08|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|90.0|-3.458|-0.705||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.705|-3.458|
71025654|NCT00601484|141558808|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.13|STANDARD_ERROR_OF_MEAN|1.267|||TWO_SIDED|90.0|-4.265|-0.004||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.004|-4.265|
71025655|NCT00601484|141558808|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.45|STANDARD_ERROR_OF_MEAN|1.531|||TWO_SIDED|90.0|-4.029|1.124||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.124|-4.029|
71077946|NCT02913105|141664399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.13||||0.0052|TWO_SIDED|90.0|1.05|1.21|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 14||1.21|1.05|0.0052
70852023|NCT01798849|141192323|OTHER||Difference in LS means|-0.65||||0.677|TWO_SIDED|95.0|-3.81|2.52|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||2.52|-3.81|0.677
71025656|NCT00601484|141558808|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.24|STANDARD_ERROR_OF_MEAN|1.293|||TWO_SIDED|90.0|-4.419|-0.063||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.063|-4.419|
70935184|NCT00487240|141371039|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||P-value for Overall Non-Nocturnal Hypoglycemic Episodes|Fisher Exact|||||||0.730
70935185|NCT00487240|141371039|SUPERIORITY_OR_OTHER|||||||0.053||95.0||||P-value for Endpoint Severe Hypoglycemic Episodes|Fisher Exact|||||||0.053
70935186|NCT00487240|141371039|SUPERIORITY_OR_OTHER|||||||0.081||95.0||||P-value for Overall Severe Hypoglycemic Episodes|Fisher Exact|||||||0.081
71025657|NCT00601484|141558809|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-7.93|||||TWO_SIDED|90.0|-27.32|11.32||||||Week 2: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\] as stratification variable.||11.32|-27.32|
71025658|NCT00601484|141558809|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-17.9|||||TWO_SIDED|90.0|-42.04|4.37||||||Week 4: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\] as stratification variable.||4.37|-42.04|
71025659|NCT00601484|141558809|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-24.44|||||TWO_SIDED|90.0|-51.58|0.67||||||Week 6: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\] as stratification variable.||0.67|-51.58|
71025660|NCT00601484|141558809|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-7.5|||||TWO_SIDED|90.0|-41.71|17.33||||||Week 10: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\] as stratification variable.||17.33|-41.71|
71025661|NCT00601484|141558809|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-21.37|||||TWO_SIDED|90.0|-54.76|7.92||||||Week 16: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\] as stratification variable.||7.92|-54.76|
71025662|NCT00601484|141558810|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.165|||TWO_SIDED|90.0|-0.591|-0.04||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.040|-0.591|
71025663|NCT00601484|141558810|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.225|||TWO_SIDED|90.0|-0.734|0.02||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.020|-0.734|
71025664|NCT00601484|141558810|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.211|||TWO_SIDED|90.0|-0.724|-0.015||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.015|-0.724|
70935187|NCT00487240|141371040|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||P-value for Endpoint Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.280
70935188|NCT00487240|141371040|SUPERIORITY_OR_OTHER|||||||0.193||95.0||||P-value for Overall Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.193
70935189|NCT00487240|141371040|SUPERIORITY_OR_OTHER|||||||0.042||95.0||||P-value for Endpoint Nocturnal Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.042
71025665|NCT00601484|141558810|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.238|||TWO_SIDED|90.0|-0.806|-0.005||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.005|-0.806|
71025666|NCT00601484|141558810|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.206|||TWO_SIDED|90.0|-0.47|0.223||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.223|-0.470|
71025667|NCT00601484|141558811|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-15.34|STANDARD_ERROR_OF_MEAN|8.425|||TWO_SIDED|90.0|-29.468|-1.209||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-1.209|-29.468|
71025668|NCT00601484|141558811|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-16.97|STANDARD_ERROR_OF_MEAN|11.102|||TWO_SIDED|90.0|-35.608|1.665||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.665|-35.608|
71025669|NCT00601484|141558811|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-18.04|STANDARD_ERROR_OF_MEAN|10.358|||TWO_SIDED|90.0|-35.476|-0.613||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.613|-35.476|
71025670|NCT00601484|141558811|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-19.48|STANDARD_ERROR_OF_MEAN|13.631|||TWO_SIDED|90.0|-42.418|3.46||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||3.460|-42.418|
71025671|NCT00601484|141558811|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.16|STANDARD_ERROR_OF_MEAN|10.097|||TWO_SIDED|90.0|-26.174|7.849||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||7.849|-26.174|
70852024|NCT01798849|141192323|OTHER||Difference in LS means|-0.92||||0.554|TWO_SIDED|95.0|-4.08|2.24|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||2.24|-4.08|0.554
70935190|NCT00487240|141371040|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Overall Nocturnal Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.001
70935191|NCT00487240|141371040|SUPERIORITY_OR_OTHER|||||||0.579||95.0||||P-value for Endpoint Non-Nocturnal Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.579
70935192|NCT00487240|141371040|SUPERIORITY_OR_OTHER|||||||0.531||95.0||||P-value for Overall Non-Nocturnal Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.531
71025672|NCT00601484|141558812|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.68|STANDARD_ERROR_OF_MEAN|0.404|||TWO_SIDED|90.0|-1.394|0.03||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.030|-1.394|
71025673|NCT00601484|141558812|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.454|||TWO_SIDED|90.0|-1.149|0.468||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.468|-1.149|
71025674|NCT00601484|141558812|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.449|||TWO_SIDED|90.0|-1.443|0.156||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.156|-1.443|
71025675|NCT00601484|141558812|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.546|||TWO_SIDED|90.0|-1.046|0.931||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.931|-1.046|
71025676|NCT00601484|141558812|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.673|||TWO_SIDED|90.0|-1.876|0.592||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.592|-1.876|
71025677|NCT00601484|141558813|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-34.25|STANDARD_ERROR_OF_MEAN|21.509|||TWO_SIDED|90.0|-72.879|4.375||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||4.375|-72.879|
71025678|NCT00601484|141558813|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-30.97|STANDARD_ERROR_OF_MEAN|24.418|||TWO_SIDED|90.0|-75.23|13.285||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||13.285|-75.230|
71025679|NCT00601484|141558813|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-37.18|STANDARD_ERROR_OF_MEAN|28.74|||TWO_SIDED|90.0|-90.62|16.265||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||16.265|-90.620|
71025680|NCT00601484|141558813|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.77|STANDARD_ERROR_OF_MEAN|43.222|||TWO_SIDED|90.0|-74.604|86.142||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||86.142|-74.604|
71025681|NCT00601484|141558813|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-21.35|STANDARD_ERROR_OF_MEAN|70.862|||TWO_SIDED|90.0|-164.142|121.438||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||121.438|-164.142|
71025682|NCT00601484|141558816|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.24|STANDARD_ERROR_OF_MEAN|0.788|||TWO_SIDED|90.0|-2.562|0.081||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.081|-2.562|
71025683|NCT00601484|141558816|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.12|STANDARD_ERROR_OF_MEAN|0.986|||TWO_SIDED|90.0|-2.782|0.535||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.535|-2.782|
71025684|NCT00601484|141558816|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.11|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|-3.036|0.819||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.819|-3.036|
71025685|NCT00601484|141558816|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.816|||TWO_SIDED|90.0|-1.534|1.221||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.221|-1.534|
71058528|NCT00486525|141622947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|2.2||0.058|TWO_SIDED|95.0|-8.5|0.15|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||0.15|-8.5|0.058
71108904|NCT00508482|141723312|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Least-Significant Difference|||||||<0.001
70935193|NCT00487240|141371040|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value for Endpoint Severe Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.017
71025686|NCT00601484|141558816|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.54|STANDARD_ERROR_OF_MEAN|1.083|||TWO_SIDED|90.0|-2.398|1.32||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.320|-2.398|
71025687|NCT00601484|141558817|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-10.99|STANDARD_ERROR_OF_MEAN|6.718|||TWO_SIDED|90.0|-22.25|0.277||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.277|-22.250|
71108905|NCT00508482|141723312|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Least-Significant Difference|||||||<0.001
71108906|NCT00508482|141723313|SUPERIORITY_OR_OTHER|||||||0.167|||||||ANOVA|||||||0.167
71108907|NCT00508482|141723314|SUPERIORITY_OR_OTHER|||||||0.066|||||||Kruskal-Wallis|||||||0.066
70935194|NCT00487240|141371040|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||P-value for Overall Severe Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.038
70935195|NCT00487240|141371042|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 1.5 kg was chosen to prove noninferiority of ILPS to detemir.|Mean Difference (Net)|0.97||||0.003||95.0|0.34|1.6||P-value for Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country.|Least Squares Mean Difference = Insulin Lispro Protamine Suspension minus Detemir.|If the first secondary null hypothesis (glycemic variability) is rejected, then the second secondary hypothesis (weight change) is tested at an error rate of 0.05.||1.60|0.34|0.003
70935196|NCT00487240|141371043|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value for Total Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country||||||0.023
70935197|NCT00487240|141371043|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value for Total Bolus Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country||||||0.004
70935198|NCT00487240|141371043|SUPERIORITY_OR_OTHER|||||||0.282||95.0||||P-value for Total Basal Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country||||||0.282
70935199|NCT00487240|141371044|SUPERIORITY_OR_OTHER|||||||0.82||95.0||||P-value for Total Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country||||||0.82
70935200|NCT00487240|141371044|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||P-value for Total Bolus Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country||||||0.19
71108908|NCT00508482|141723315|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
70852025|NCT01798849|141192323|OTHER||Difference in LS means|-2.29||||0.137|TWO_SIDED|95.0|-5.35|0.78|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.78|-5.35|0.137
70935201|NCT00487240|141371044|SUPERIORITY_OR_OTHER|||||||0.416||95.0||||P-value for Total Basal Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country||||||0.416
70935202|NCT02095678|141371079|OTHER|Significance (alpha) set to 0.05||||||0.211|||||||t-test, 2 sided|||||||0.211
70935203|NCT02095678|141371082|OTHER|Significance (alpha) set to 0.05|||||<|0.01|||||||t-test, 2 sided|||||||<0.01
70935204|NCT02095678|141371083|OTHER|Significance (alpha) set to 0.05|||||<|0.01|||||||t-test, 2 sided|||||||<0.01
70935205|NCT04660799|141371090|NON_INFERIORITY|The lower limit of the two-sided 90% confidence interval (CI) should be above 0.80 in order to show non-inferiority of Ctrough SC versus Ctrough IV.|Ratio Ctrough SC/Ctrough IV|1.52|||||TWO_SIDED|90.0|1.28|1.79||||||Geometric mean ratio of Ctrough SC/Ctrough IV and 90% confidence interval were estimated based on an ANCOVA model adjusted for tumor load at baseline.||1.79|1.28|
70935206|NCT04660799|141371091|NON_INFERIORITY|The lower limit of the two-sided 90% confidence interval (CI) should be above 0.80 in order to show non-inferiority of AUCsc versus AUCiv.|Geometric mean ratio of AUCsc/AUCiv|1.25|||||TWO_SIDED|90.0|1.1|1.42||||||Geometric mean ratio of AUCsc/AUCiv and 90% confidence interval were estimated based on an ANCOVA model adjusted for tumor load at baseline.||1.42|1.10|
70935207|NCT04660799|141371096|SUPERIORITY||Difference in CRR|18.27|||||TWO_SIDED|95.0|-8.92|45.45||||||Stratified by IPI score: IPI 0-2 = low to low-intermediate risk versus IPI 3-5 = high-intermediate to high risk||45.45|-8.92|
70935208|NCT04660799|141371097|SUPERIORITY||Difference in ORR Investigator|17.63|||||TWO_SIDED|95.0|-6.86|42.11||||||Investigator; Stratified by IPI score: IPI 0-2 = low to low-intermediate risk versus IPI 3-5 = high-intermediate to high risk||42.11|-6.86|
70852026|NCT01798849|141192323|OTHER||Difference in LS means|-3.78||||0.006|TWO_SIDED|95.0|-6.37|-1.19|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-1.19|-6.37|0.006
70935209|NCT04660799|141371097|SUPERIORITY||Difference in ORR IRC|14.1|||||TWO_SIDED|95.0|-12.68|40.88||||||IRC; Stratified by IPI score: IPI 0-2 = low to low-intermediate risk versus IPI 3-5 = high-intermediate to high risk||40.88|-12.68|
70935210|NCT04660799|141371098|SUPERIORITY||Difference in CRR|7.05|||||TWO_SIDED|95.0|-22.49|36.59||||||Stratified by IPI score: IPI 0-2 = low to low-intermediate risk versus IPI 3-5 = high-intermediate to high risk||36.59|-22.49|
70935211|NCT04660799|141371099|SUPERIORITY||Difference in CRR|18.59|||||TWO_SIDED|95.0|-9.55|46.73||||||Stratified by IPI score: IPI 0-2 = low to low-intermediate risk versus IPI 3-5 = high-intermediate to high risk||46.73|-9.55|
70935212|NCT01934452|141371124|SUPERIORITY||Hodges Lehmann estimator|2.8|||<|0.001|TWO_SIDED|95.0|2.2|3.8|||Wilcoxon (Mann-Whitney)|||||3.8|2.2|<0.001
70935213|NCT01934452|141371125|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
70935214|NCT01934452|141371126|SUPERIORITY|||||||1|||||||Fisher Exact|||Extended or partial nephrectomy||||1.000
70935215|NCT01934452|141371126|SUPERIORITY|||||||0.809|||||||Chi-squared|||Nephrectomy with or without adrenalectomy||||0.809
70935216|NCT01934452|141371126|SUPERIORITY|||||||0.019|||||||Chi-squared|||Nephrectomy with or without curettage||||0.019
70935217|NCT01934452|141371126|SUPERIORITY|||||||0.734|||||||Fisher Exact|||Open or laparoscopic nephrectomy||||0.734
70935218|NCT01934452|141371127|SUPERIORITY||Hodges Lehmann estimator|-3.7||||0.23|TWO_SIDED|95.0|-13.2|1.6|||Wilcoxon (Mann-Whitney)|||||1.6|-13.2|0.230
70935219|NCT01934452|141371128|SUPERIORITY|||||||0.695|||||||Fisher Exact|||Sarcomatoid contingent||||0.695
70935220|NCT01934452|141371129|SUPERIORITY|||||||0.316|||||||Chi-squared|||M class||||0.316
70935221|NCT01934452|141371130|SUPERIORITY||Hodges Lehmann estimator|-2.0||||0.778|TWO_SIDED|95.0|-22.0|18.0|||Wilcoxon (Mann-Whitney)|||||18.0|-22.0|0.778
70935222|NCT01934452|141371131|SUPERIORITY|||||||0.812|||||||Fisher Exact|||||||0.812
70935223|NCT01934452|141371132|SUPERIORITY||Odds Ratio (OR)|2.47||||0.077|TWO_SIDED|95.0|0.9|6.77|||Chi-squared|||Presence of necrosis||6.77|0.90|0.077
70935224|NCT01934452|141371132|SUPERIORITY||Odds Ratio (OR)|1.25||||0.673|TWO_SIDED|95.0|0.44|3.52|||Chi-squared|||Vascular embolism||3.52|0.44|0.673
70935225|NCT01934452|141371132|SUPERIORITY||Odds Ratio (OR)|1.04||||1|TWO_SIDED|95.0|0.27|3.97|||Fisher Exact|||Sarcomatoid component||3.97|0.27|1.000
70935226|NCT01934452|141371133|SUPERIORITY||Hodges Lehmann estimator|-0.2||||0.865|TWO_SIDED|95.0|-1.5|1.6|||Wilcoxon (Mann-Whitney)|||||1.6|-1.5|0.865
71108909|NCT00508482|141723315|SUPERIORITY_OR_OTHER|||||||0.024|||||||Least-Significant Difference|||||||0.024
71108910|NCT00508482|141723315|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Least-Significant Difference|||||||<0.001
71108911|NCT00508482|141723315|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Least-Significant Difference|||||||<0.001
70935227|NCT01934452|141371134|SUPERIORITY|||||||0.011|||||||Chi-squared|||Lung||||0.011
71025688|NCT00601484|141558817|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.43|STANDARD_ERROR_OF_MEAN|8.66|||TWO_SIDED|90.0|-23.001|6.132||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||6.132|-23.001|
71025689|NCT00601484|141558817|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.14|STANDARD_ERROR_OF_MEAN|9.737|||TWO_SIDED|90.0|-24.602|8.327||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||8.327|-24.602|
71025690|NCT00601484|141558817|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.45|STANDARD_ERROR_OF_MEAN|7.406|||TWO_SIDED|90.0|-13.948|11.04||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||11.040|-13.948|
71025691|NCT00601484|141558817|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.83|STANDARD_ERROR_OF_MEAN|9.352|||TWO_SIDED|90.0|-23.884|8.234||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||8.234|-23.884|
71025692|NCT00601484|141558818|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.064|||||TWO_SIDED|90.0|1.709|15.007||||||Week 6: Analysis was based on proportional odds analysis, to determine the odds ratio for the odds of responding (compared to not responding) on Tanezumab vs placebo.||15.007|1.709|
71025693|NCT00601484|141558818|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.722|||||TWO_SIDED|90.0|0.756|9.795||||||Week 16: Analysis was based on proportional odds analysis, to determine the odds ratio for the odds of responding (compared to not responding) on Tanezumab vs placebo.||9.795|0.756|
71025694|NCT01463683|141558842|NON_INFERIORITY_OR_EQUIVALENCE|Incidence of seroprotection with V232-2XP SC is non-inferior to V232-1XP SC if the lower bound of the 95% confidence interval of the difference is greater than -10%|Difference in percentage of participants|7.6|||||TWO_SIDED|95.0|1.9|13.6|||Miettinen & Nurminen|||||13.6|1.9|
71025695|NCT01463683|141558843|SUPERIORITY_OR_OTHER||Difference in percentage of participants|4.9||||0.162|TWO_SIDED|95.0|-2.0|11.9|||Miettinen & Nurminen|||||11.9|-2.0|0.162
71025696|NCT01463683|141558843|SUPERIORITY_OR_OTHER||Difference in percentage of participants|11.0||||0.028|TWO_SIDED|95.0|1.1|21.6|||Miettinen & Nurminen|||||21.6|1.1|0.028
71025697|NCT01463683|141558843|SUPERIORITY_OR_OTHER||Difference in percentage of participants|6.0||||0.246|TWO_SIDED|95.0|-4.0|16.8|||Miettinen & Nurminen|||||16.8|-4.0|0.246
71025698|NCT01463683|141558844|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-0.7||||0.659|TWO_SIDED|95.0|-3.8|2.4|||Miettinen & Nurminen|||||2.4|-3.8|0.659
71025699|NCT01463683|141558844|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-1.6||||0.459|TWO_SIDED|95.0|-7.7|2.2|||Miettinen & Nurminen|||||2.2|-7.7|0.459
71025700|NCT01463683|141558844|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-0.9||||0.686|TWO_SIDED|95.0|-7.1|3.0|||Miettinen & Nurminen|||||3.0|-7.1|0.686
71025701|NCT01618305|141558847|SUPERIORITY|P-value was calculated using a Cochran-Mantel-Haenszel test, stratified by gestational age at entry (20-\<28 weeks; 28-\<31 weeks; 31-\<34 weeks; 34-\<37 weeks)||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
71025702|NCT01618305|141558848|SUPERIORITY|||||||0.557|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by gestational age at entry (20-\<28 weeks; 28-\<31 weeks; 31-\<34 weeks; 34-\<37 weeks)||||||0.557
71025703|NCT01618305|141558849|SUPERIORITY|||||||0.909|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by gestational age at entry (20-\<28 weeks; 28-\<31 weeks; 31-\<34 weeks; 34-\<37 weeks).||||||0.909
71025704|NCT01618305|141558850|SUPERIORITY|||||||0.938|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by maternal gestational age at entry (20-\<28 weeks; 28-\<31 weeks; 31-\<34 weeks; 34-\<37 weeks).||||||0.938
71108912|NCT00508482|141723316|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
70935228|NCT01934452|141371134|SUPERIORITY|||||||0.132|||||||Chi-squared|||Bones||||0.132
71025705|NCT01618305|141558851|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by gestational age at entry (20-\<28 weeks; 28-\<31 weeks; 31-\<34 weeks; 34-\<37 weeks).||||||<0.001
71025706|NCT01618305|141558852|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by gestational age at entry (20-\<28 weeks; 28-\<31 weeks; 31-\<34 weeks; 34-\<37 weeks).||||||<0.001
70852027|NCT03158285|141192358|SUPERIORITY||Difference in percentage|31.2|||<|0.001|TWO_SIDED|95.0|22.9|39.5|||Cochran-Mantel-Haenszel|||||39.5|22.9|< 0.001
70852028|NCT03158285|141192358|SUPERIORITY||Difference in percentage|30.8|||<|0.001|TWO_SIDED|95.0|22.4|39.1|||Cochran-Mantel-Haenszel|||||39.1|22.4|< 0.001
70935229|NCT01934452|141371134|SUPERIORITY|||||||0.473|||||||Chi-squared|||Liver||||0.473
70935230|NCT01934452|141371134|SUPERIORITY|||||||0.101|||||||Fisher Exact|||Adrenal glands||||0.101
71025707|NCT01618305|141558857|SUPERIORITY|||||||0.623|||||||Fisher Exact|||||||0.623
71025708|NCT01618305|141558858|SUPERIORITY|||||||0.63|||||||Fisher Exact|||||||.63
71025709|NCT01618305|141558859|SUPERIORITY|||||||0.54|||||||Fisher Exact|||||||.54
71025710|NCT01618305|141558860|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
71025711|NCT01618305|141558861|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
71025712|NCT01618305|141558862|SUPERIORITY|||||||0.064|||||||Fisher Exact|||The proportion of HIV-infected infants among those who had a determinable HIV-infection status was compared between arms.||||0.064
71025713|NCT02708277|141558865|SUPERIORITY_OR_OTHER|||||||0.009|||||||Chi-squared|||||||0.009
71025714|NCT02708277|141558866|SUPERIORITY_OR_OTHER|||||||0.303|||||||Chi-squared|||||||0.303
71025715|NCT02708277|141558867|SUPERIORITY_OR_OTHER|||||||0.606|||||||t-test, 2 sided|||||||0.606
71025716|NCT02708277|141558868|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|||||||0.05
71108913|NCT00508482|141723316|SUPERIORITY_OR_OTHER|||||||0.627||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||0.627
71108914|NCT00508482|141723316|SUPERIORITY_OR_OTHER||||||<|0.001||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||<0.001
71108915|NCT00508482|141723316|SUPERIORITY_OR_OTHER||||||<|0.001||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||<0.001
70852029|NCT03158285|141192359|SUPERIORITY||Least Square (LS) Mean difference|-0.2372|||<|0.001|TWO_SIDED|95.0|-0.321|-0.1534|||ANCOVA|||||-0.1534|-0.3210|< 0.001
70852030|NCT03158285|141192359|SUPERIORITY||LS Mean difference|-0.2704|||<|0.001|TWO_SIDED|95.0|-0.3544|-0.1864|||ANCOVA|||||-0.1864|-0.3544|< 0.001
71025717|NCT04345471|141558878|SUPERIORITY|To adjust for the multiplicity, only when the superiority of MD-120 50 mg to Placebo was verified, the superiority of MD-120 100 mg to Placebo was tested.|LS mean difference|-0.6||||0.509|TWO_SIDED|95.0|-2.5|1.2||A priori threshold for statistical significance is p\<0.05, 2-sided.|MMRM|||||1.2|-2.5|0.509
70852031|NCT03158285|141192360|SUPERIORITY||Difference in percentage|17.2|||<|0.001||95.0|10.0|24.4||Nominal|Cochran-Mantel-Haenszel|||||24.4|10.0|< 0.001
71025718|NCT04345471|141558878|SUPERIORITY|To adjust for the multiplicity, only when the superiority of MD-120 50 mg to Placebo was verified, the superiority of MD-120 100 mg to Placebo was tested.|LS mean difference|-1.4||||0.131|TWO_SIDED|95.0|-3.3|0.4||A priori threshold for statistical significance is p\<0.05, 2-sided. The value was based on the post-hoc analysis by not taking into account the multiplicity.|MMRM|||||0.4|-3.3|0.131
71025719|NCT04345471|141558880|SUPERIORITY||LS mean difference|-0.2||||0.811|TWO_SIDED|95.0|-1.5|1.2||A priori threshold for statistical significance is p\<0.05, 2-sided.|MMRM|||||1.2|-1.5|0.811
71025720|NCT04345471|141558880|SUPERIORITY||LS mean difference|-0.5||||0.424|TWO_SIDED|95.0|-1.9|0.8||A priori threshold for statistical significance is p\<0.05, 2-sided.|MMRM|||||0.8|-1.9|0.424
71058529|NCT00486525|141622947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|2.2||0.002|TWO_SIDED|95.0|-11.4|-2.7|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||-2.7|-11.4|0.002
71058530|NCT00486525|141622947|SUPERIORITY_OR_OTHER||Slope|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.019|TWO_SIDED|95.0|-3.1|-0.28|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of MFSI-SF Fatigue for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||-0.28|-3.1|0.019
71058531|NCT00486525|141622947|SUPERIORITY_OR_OTHER||Slope|-2.8|STANDARD_ERROR_OF_MEAN|0.71||0.0001|TWO_SIDED|95.0|-4.2|-1.4|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of MFSI-SF fatigue for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||-1.4|-4.2|0.0001
71058532|NCT00486525|141622948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4|STANDARD_ERROR_OF_MEAN|2.5||0.01|TWO_SIDED|95.0|1.4|11.4|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||11.4|1.4|0.01
71058533|NCT00486525|141622948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|2.5||0.01|TWO_SIDED|95.0|1.5|11.6|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||11.6|1.5|0.01
71108916|NCT00508482|141723317|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
71108917|NCT00508482|141723317|SUPERIORITY_OR_OTHER|||||||0.587||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||0.587
71108918|NCT00508482|141723317|SUPERIORITY_OR_OTHER|||||||0.001||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||0.001
70852032|NCT03158285|141192360|SUPERIORITY||Difference in percentage|18.8|||<|0.001|TWO_SIDED|95.0|11.5|26.1||Nominal|Cochran-Mantel-Haenszel|||||26.1|11.5|< 0.001
71025721|NCT05188521|141558917|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71025722|NCT05188521|141558918|SUPERIORITY|||||||0.593|||||||Wilcoxon (Mann-Whitney)|||||||0.593
71025723|NCT05188521|141558919|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
70852033|NCT03158285|141192361|SUPERIORITY||Difference in percentage|50.9|||<|0.001|TWO_SIDED|95.0|42.2|59.7|||Cochran-Mantel-Haenszel|||||59.7|42.2|<0.001
70852034|NCT03158285|141192361|SUPERIORITY||Difference in percentage|49.8|||<|0.001|TWO_SIDED|95.0|41.2|58.4|||Cochran-Mantel-Haenszel|||||58.4|41.2|< 0.001
70852035|NCT03158285|141192362|SUPERIORITY||Difference in percentage|21.5|||<|0.001|TWO_SIDED|95.0|13.1|30.0||Nominal|Cochran-Mantel-Haenszel|||||30.0|13.1|< 0.001
70852036|NCT03158285|141192362|SUPERIORITY||Difference in percentage|22.2|||<|0.001|TWO_SIDED|95.0|13.7|30.7||Nominal|Cochran-Mantel-Haenszel|||||30.7|13.7|< 0.001
70852037|NCT03158285|141192363|SUPERIORITY||LS Mean difference|-0.43||||0.072|TWO_SIDED|95.0|-0.9|0.03|||ANCOVA|||||0.03|-0.90|0.072
71025724|NCT05188521|141558920|SUPERIORITY|||||||0.138|||||||Wilcoxon (Mann-Whitney)|||||||0.138
71025725|NCT05188521|141558921|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71025726|NCT05188521|141558922|SUPERIORITY|||||||0.357|||||||Wilcoxon (Mann-Whitney)|||||||0.357
71025727|NCT05188521|141558923|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
71025728|NCT05188521|141558924|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
70935231|NCT01934452|141371134|SUPERIORITY|||||||0.445|||||||Fisher Exact|||Pancreas||||0.445
70935232|NCT01934452|141371134|SUPERIORITY|||||||0.04|||||||Chi-squared|||Lymph nodes||||0.040
70935233|NCT01934452|141371135|SUPERIORITY|||||||1|||||||Fisher Exact|||Supradiaphragmatic||||1.000
71025729|NCT01341639|141558955|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|11.37|||<|0.001|TWO_SIDED|95.0|8.44|14.68||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for PRP|PR5I minus INFANRIX™ hexa|14.68|8.44|< 0.001
71025730|NCT01341639|141558955|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.0|||<|0.001|TWO_SIDED|95.0|-0.95|0.96||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Diphtheria|PR5I minus INFANRIX™ hexa|0.96|-0.95|< 0.001
71025731|NCT01341639|141558955|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.0|||<|0.001|TWO_SIDED|95.0|-0.71|0.74|||Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Tetanus|PR5I minus INFANRIX™ hexa|0.74|-0.71|< 0.001
71025732|NCT01341639|141558955|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.19|||<|0.001|TWO_SIDED|95.0|-0.51|1.07||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for IPV1|PR5I minus INFANRIX™ hexa|1.07|-0.51|< 0.001
71025733|NCT01341639|141558955|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.19|||<|0.001|TWO_SIDED|95.0|-0.69|1.21||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for IPV2|PR5I minus INFANRIX™ hexa|1.21|-0.69|< 0.001
71025734|NCT01341639|141558955|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|0.73||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for IPV3|PR5I minus INFANRIX™ hexa|0.73|-0.7|< 0.001
71025735|NCT01341639|141558956|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.58|||<|0.001|TWO_SIDED|95.0|-0.49|1.85||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for HBsAg|PR5I minus INFANRIX™ hexa|1.85|-0.49|< 0.001
71025736|NCT01341639|141558956|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|1.33|||<|0.001|TWO_SIDED|95.0|0.32|2.86||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for PT|PR5I minus INFANRIX™ hexa|2.86|0.32|< 0.001
71025737|NCT01341639|141558956|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-2.59|||<|0.001|TWO_SIDED|95.0|-4.39|-1.29||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for FHA|PR5I minus INFANRIX™ hexa|-1.29|-4.39|< 0.001
71058534|NCT00486525|141622948|SUPERIORITY_OR_OTHER||Slope|2.1|STANDARD_ERROR_OF_MEAN|0.85||0.016|TWO_SIDED|95.0|0.4|3.75|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of vitality (SF-36) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||3.75|0.40|0.016
71058535|NCT00486525|141622948|SUPERIORITY_OR_OTHER||Slope|2.5|STANDARD_ERROR_OF_MEAN|0.85||0.0045|TWO_SIDED|95.0|0.77|4.14|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of vitality (SF-36) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||4.14|0.77|0.0045
71108919|NCT00508482|141723317|SUPERIORITY_OR_OTHER||||||<|0.001||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||<0.001
71108920|NCT00508482|141723318|SUPERIORITY_OR_OTHER|||||||0.006|||||||Chi-squared|||||||0.006
70935234|NCT01934452|141371135|SUPERIORITY|||||||0.295|||||||Fisher Exact|||Infradiaphragmatic||||0.295
70935235|NCT01934452|141371136|SUPERIORITY|||||||0.042|||||||Fisher Exact|||||||0.042
70935236|NCT01934452|141371137|SUPERIORITY|||||||0.027|||||||Chi-squared|||||||0.027
70935237|NCT01934452|141371138|SUPERIORITY||Hodges Lehmann estimator|-1.0|||<|0.001|TWO_SIDED|95.0|-1.0|-1.0|||Wilcoxon (Mann-Whitney)|||||-1.0|-1.0|<0.001
70935238|NCT01934452|141371139|SUPERIORITY|||||||0.009|||||||Fisher Exact|||||||0.009
71025738|NCT01341639|141558956|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.03|||<|0.001|TWO_SIDED|95.0|-1.4|1.52||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for PRN|PR5I minus INFANRIX™ hexa|1.52|-1.4|< 0.001
71025739|NCT01341639|141558958|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.26|||<|0.001|TWO_SIDED|95.0|-2.82|2.25||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Measles|PR5I minus INFANRIX™ hexa|2.25|-2.82|< 0.001
70852038|NCT03158285|141192363|SUPERIORITY||LS Mean difference|-0.66||||0.011|TWO_SIDED|95.0|-1.13|-0.19|||ANCOVA|||||-0.19|-1.13|0.011
70852039|NCT03158285|141192364|SUPERIORITY||Difference in response rates|20.1||||0.03|TWO_SIDED|95.0|11.8|28.5|||Cochran-Mantel-Haenszel|||||28.5|11.8|0.030
71025740|NCT01341639|141558958|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|3.07|||<|0.001|TWO_SIDED|95.0|-0.12|6.4||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Mumps|PR5I minus INFANRIX™ hexa|6.4|-0.12|< 0.001
71025741|NCT01341639|141558958|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.39|||<|0.001|TWO_SIDED|95.0|-1.5|2.34||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Rubella|PR5I minus INFANRIX™ hexa|2.34|-1.5|< 0.001
71025742|NCT01341639|141558958|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.02|||<|0.001|TWO_SIDED|95.0|-2.11|2.06||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Varicella|PR5I minus INFANRIX™ hexa|2.06|-2.11|< 0.001
71025743|NCT01341639|141558959|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-0.7|||||TWO_SIDED|95.0|-1.9|0.4|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: ISRs or systemic AEs|PR5I minus INFANRIX™ hexa|0.4|-1.9|
71025744|NCT01341639|141558959|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-0.3|||||TWO_SIDED|95.0|-1.8|1.1|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: ISRs or vaccine-related systemic AEs|PR5I minus INFANRIX™ hexa|1.1|-1.8|
71025745|NCT01341639|141558959|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|1.1|||||TWO_SIDED|95.0|-2.1|4.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 ISR|PR5I minus INFANRIX™ hexa|4.3|-2.1|
71025746|NCT01341639|141558959|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|0.9|||||TWO_SIDED|95.0|-2.4|4.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 solicited ISR|PR5I minus INFANRIX™ hexa|4.3|-2.4|
71025747|NCT01341639|141558959|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-2.4|0.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 systemic AE|PR5I minus INFANRIX™ hexa|0.3|-2.4|
71025748|NCT01341639|141558959|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-0.9|||||TWO_SIDED|95.0|-3.2|1.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 vaccine-related systemic AE|PR5I minus INFANRIX™ hexa|1.3|-3.2|
70935239|NCT02037568|141371185|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||||||.96
70935240|NCT02037568|141371186|SUPERIORITY|||||||0.007|||||||Mixed Models Analysis|||||||0.007
71025749|NCT01341639|141558959|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-1.5|||||TWO_SIDED|95.0|-3.3|0.2|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 solicited systemic AE|PR5I minus INFANRIX™ hexa|0.2|-3.3|
71077947|NCT02913105|141664399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.06||||0.1822|TWO_SIDED|90.0|0.99|1.15|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 28||1.15|0.99|0.1822
70935241|NCT02037568|141371187|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||0.08
70935242|NCT02037568|141371188|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
70935243|NCT02037568|141371189|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|||||||0.070
70935244|NCT02037568|141371190|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||||||0.96
70935245|NCT02037568|141371191|SUPERIORITY|||||||0.74|||||||Mixed Models Analysis|||||||0.74
70935246|NCT02037568|141371192|SUPERIORITY|||||||0.79|||||||Mixed Models Analysis|||||||0.79
70935247|NCT02037568|141371193|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|||||||0.86
71025750|NCT01341639|141558959|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-1.3|||||TWO_SIDED|95.0|-3.7|1.1|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 vaccine-related solicited systemic AE|PR5I minus INFANRIX™ hexa|1.1|-3.7|
71025751|NCT01341639|141558960|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|4.8|||||TWO_SIDED|95.0|-0.5|10.1|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site erythema|PR5I minus INFANRIX™ hexa|10.1|-0.5|
71025752|NCT01341639|141558960|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|1.8|||||TWO_SIDED|95.0|-3.2|6.8|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site pain|PR5I minus INFANRIX™ hexa|6.8|-3.2|
71025753|NCT01341639|141558960|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|4.0|||||TWO_SIDED|95.0|-1.6|9.6|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site swelling|PR5I minus INFANRIX™ hexa|9.6|-1.6|
71025754|NCT01341639|141558961|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-1.8|2.1|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site bruising|PR5I minus INFANRIX™ hexa|2.1|-1.8|
71025755|NCT01341639|141558961|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|0.6|||||TWO_SIDED|95.0|-0.6|2.1|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site haematoma|PR5I minus INFANRIX™ hexa|2.1|-0.6|
71025756|NCT01341639|141558961|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-0.7|||||TWO_SIDED|95.0|-2.3|0.8|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site haemorrhage|PR5I minus INFANRIX™ hexa|0.8|-2.3|
71025757|NCT01341639|141558961|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-3.7|||||TWO_SIDED|95.0|-7.8|0.5|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site induration|PR5I minus INFANRIX™ hexa|0.5|-7.8|
71025758|NCT01341639|141558961|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-0.2|||||TWO_SIDED|95.0|-1.7|1.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site nodule|PR5I minus INFANRIX™ hexa|1.3|-1.7|
71025759|NCT01341639|141558961|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|1.1||||||95.0|-0.6|3.0|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site warmth|PR5I minus INFANRIX™ hexa|3|-0.6|
71025760|NCT01341639|141558962|OTHER|Miettinen \& Nurminen method.|Risk Difference (RD)|-2.5|||||TWO_SIDED|95.0|-6.3|1.4|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Crying|PR5I minus INFANRIX™ hexa|1.4|-6.3|
71025761|NCT01341639|141558962|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-3.1|||||TWO_SIDED|95.0|-8.4|2.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Decreased appetite|PR5I minus INFANRIX™ hexa|2.3|-8.4|
71025762|NCT01341639|141558962|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|2.1|||||TWO_SIDED|95.0|-1.7|6.0|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Irritability|PR5I minus INFANRIX™ hexa|6|-1.7|
71025763|NCT01341639|141558962|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-1.7|||||TWO_SIDED|95.0|-6.7|3.4|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Pyrexia|PR5I minus INFANRIX™ hexa|3.4|-6.7|
71025764|NCT01341639|141558962|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-3.2|||||TWO_SIDED|95.0|-7.8|1.4|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Somnolence|PR5I minus INFANRIX™ hexa|1.4|-7.8|
70935248|NCT00621842|141371202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.5|||<|0.01|TWO_SIDED|95.0|-18.0|-12.9|||t-test, 2 sided|df=53||The null hypothesis is that the mean difference score between the 12 week time point or LOCF and baseline is zero.||-12.9|-18.0|<.01
71025765|NCT01341639|141558962|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|0.8|||||TWO_SIDED|95.0|-4.4|6.0|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Vomiting|PR5I minus INFANRIX™ hexa|6|-4.4|
71025766|NCT01132118|141558963|SUPERIORITY_OR_OTHER|||||||0.93||||||Unadjusted|Wilcoxon (Mann-Whitney)|||The P-value calculated was for the difference betweeen the change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.||||0.930
71025767|NCT01132118|141558963|SUPERIORITY_OR_OTHER|||||||0.785||||||Adjusted for weight change.|Regression, Linear|||The P-value was calculated for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.||||0.785
71025768|NCT01132118|141558964|SUPERIORITY_OR_OTHER|||||||0.575||||||Unadjusted P-value|Wilcoxon (Mann-Whitney)|||P-value for the difference between change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.||||0.575
71025769|NCT01132118|141558964|SUPERIORITY_OR_OTHER|||||||0.308||||||Adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.||||0.308
71058536|NCT00486525|141622949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.98||0.28|TWO_SIDED|95.0|-3.0|0.88|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||0.88|-3.0|0.28
71108921|NCT00508482|141723318|SUPERIORITY_OR_OTHER|||||||0.507||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||0.507
70852040|NCT03158285|141192364|SUPERIORITY||Difference in response rates|14.6||||0.03|TWO_SIDED|95.0|6.4|22.7|||Cochran-Mantel-Haenszel|||||22.7|6.4|0.030
70935249|NCT00621842|141371204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.2|||<|0.01|TWO_SIDED|95.0|-17.5|-12.9|||t-test, 2 sided|||The null hypothesis is that the mean difference score between the 12 week time point or LOCF and baseline is zero.||-12.9|-17.5|<.01
71077948|NCT02913105|141664399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.14||||0.0159|TWO_SIDED|90.0|1.04|1.24|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 42||1.24|1.04|0.0159
71025770|NCT01132118|141558965|SUPERIORITY_OR_OTHER|||||||0.468||||||Unadjusted|Wilcoxon (Mann-Whitney)|||P-value for the difference betweeen change during hydroxychloroquine versus placebo suing Wilcoxon signed-rank tests.||||0.468
71025771|NCT01132118|141558965|SUPERIORITY_OR_OTHER|||||||0.902||||||Adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.||||0.902
71025772|NCT01132118|141558966|SUPERIORITY_OR_OTHER|||||||0.004||||||Unadjusted|Wilcoxon (Mann-Whitney)|||P-value for the difference between the change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.||||0.004
71025773|NCT01132118|141558966|SUPERIORITY_OR_OTHER|||||||0.004||||||Adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.||||0.004
71025774|NCT01132118|141558967|SUPERIORITY_OR_OTHER|||||||0.009||||||Unadjusted|Wilcoxon (Mann-Whitney)|||P-value for the difference between the change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.||||0.009
71025775|NCT01132118|141558967|SUPERIORITY_OR_OTHER|||||||0.011||||||Adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.||||0.011
71025776|NCT01132118|141558968|SUPERIORITY_OR_OTHER|||||||0.73||||||Unadjusted|Wilcoxon (Mann-Whitney)|||P-value for the difference between the change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.||||0.730
71025777|NCT01132118|141558968|SUPERIORITY_OR_OTHER|||||||0.208||||||Adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.||||0.208
71025778|NCT01132118|141558969|SUPERIORITY_OR_OTHER|||||||0.487||||||Unadjusted P-value.|Wilcoxon (Mann-Whitney)|||P-value for the difference between the change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.||||0.487
71077949|NCT02913105|141664399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.08||||0.1524|TWO_SIDED|90.0|0.99|1.19|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 56||1.19|0.99|0.1524
71025779|NCT01132118|141558969|SUPERIORITY_OR_OTHER|||||||0.884||||||P-value adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxycholorquine versus placebo from a linear regression model.||||0.884
71025780|NCT00494975|141558991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94|STANDARD_ERROR_OF_MEAN|0.32|<|0.05|TWO_SIDED|95.0|0.31|1.56|||generalized estimating equations (GEE)|||The VAS score of pruritus intensity was recorded for each participant at baseline and weekly until week 12 so that each one had 12 repeatedly measured data scores. To investigate the predictive effects of age, sex, comorbid diseases, phototherapy, and results of blood laboratory exams on the intensity of pruritus, marginal linear regression model was fitted to the repeatedly measured VAS score data using the generalized estimating equations (GEE) method.||1.56|0.31|<0.05
71025781|NCT02891200|141559083|SUPERIORITY||Predicted Mean Difference|1.46||||0.467|TWO_SIDED|95.0|-2.47|5.38|||Mixed Models Analysis|Mixed effects linear model with study site and setting as fixed effects, and adjusted for baseline SGRQ domain scores.||||5.38|-2.47|0.467
71025782|NCT02322879|141559112|SUPERIORITY|||||||0.59|||||||Chi-squared|||||||0.59
71025783|NCT02637076|141559113|OTHER|||||||0.31|||||||repeated measures ANOVA|F(2,36)=1.26||||||0.31
71025784|NCT02637076|141559118|OTHER|||||||0.748|||||||repeated measures ANOVA|||||||0.748
71025785|NCT01633827|141559125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
71025786|NCT01633827|141559126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.025||||0.025|TWO_SIDED||||||t-test, 2 sided|||||||0.025
71025787|NCT01633827|141559127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.5
71025788|NCT01633827|141559128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.5
71077950|NCT02913105|141664399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.08||||0.1749|TWO_SIDED|90.0|0.98|1.2|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 84||1.20|0.98|0.1749
71077951|NCT02913105|141664399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.02||||0.7503|TWO_SIDED|90.0|0.92|1.13|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 112 (EOS)||1.13|0.92|0.7503
70935250|NCT00621842|141371205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.49|TWO_SIDED|95.0|-1.82|0.88|||t-test, 2 sided|||The null hypothesis is that the mean difference score between the 12 week time point or LOCF and baseline is zero.||.88|-1.82|.49
71108922|NCT00508482|141723318|SUPERIORITY_OR_OTHER|||||||0.005||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||0.005
71108923|NCT00508482|141723318|SUPERIORITY_OR_OTHER|||||||0.008||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||0.008
71108924|NCT02289469|141723319|SUPERIORITY||Mean Difference (Final Values)|23.8|||<|0.0001|TWO_SIDED|95.0|16.0|31.6|||Chi-squared|||A chi-square test was used to test for differences in proportions between intervention and control groups.||31.6|16.0|<0.0001
71108925|NCT02289469|141723320|OTHER||||||<|0.01|||||||Other|||Descriptive statistics (counts, frequencies) were used to summarize responses.||||<0.01
71108926|NCT00587041|141723321|SUPERIORITY_OR_OTHER|||||||0.3|||||||Kruskal-Wallis|||80% power for 0.66 DG difference from placebo. The reported value is the overall p-value for CaOx supersaturation by Kruskal-Wallis test of equal change across all three groups, no pair-wise comparison.||||0.3
71108927|NCT00587041|141723321|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||t-test, 1 sided|||Ranked sum T-test for placebo group CaOx SS comparison between 0 and 6 weeks||||0.045
71108928|NCT00587041|141723321|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||t-test, 1 sided|||Ranked sum T-test for AKSB group CaOX SS comparison between 0 and 6 weeks||||0.67
71108929|NCT00587041|141723321|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||t-test, 1 sided|||Ranked-sum T-Test for Oxadrop group CaOX SS comparison between 0 and 6 weeks||||0.30
71108930|NCT00110214|141723329|NON_INFERIORITY_OR_EQUIVALENCE|Superiority and futility analyses were conducted for the OS end point. The Lan-Demets analog of the Emerson-Fleming sequential boundary was used to maintain the overall significance level of alpha=0.05 while conducting interim analyses on OS. The final analysis was performed when 748 deaths had been observed. An intention-to-treat approach was used in the analysis for all the clinical end points with the exception of toxicity.|Hazard Ratio (HR)|0.91||||0.181|TWO_SIDED|95.0|0.7|1.05||The primary analysis was adjusted for the stratification factors (24-mo survival probability as predicted by a validated nomogram (\<10%,10%-29.9%,\>=30%), age (\<65, \>=65 years) and prior history of arterial events (yes, no)).|Log Rank|||||1.05|0.7|0.181
70935251|NCT00621842|141371206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|||<|0.01|TWO_SIDED|95.0|-2.43|-1.68|||t-test, 2 sided|||The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.||-1.68|-2.43|<.01
70935252|NCT00621842|141371207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.8|TWO_SIDED|95.0|-0.36|0.28|||t-test, 2 sided|||The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.||.28|-.36|.80
70935253|NCT00621842|141371208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83||||0.36||95.0|-0.97|2.62|||t-test, 2 sided|||The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.||2.62|-.97|.36
70935254|NCT00621842|141371210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.08|TWO_SIDED|95.0|-1.67|0.09|||t-test, 2 sided|||The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.||.09|-1.67|.08
70935255|NCT00621842|141371211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.04||95.0|-1.03|-0.04|||t-test, 2 sided|||The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.||-.04|-1.03|.04
70935256|NCT00849485|141371237|NON_INFERIORITY_OR_EQUIVALENCE|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Geometric Test/Ref Ratio x 100|98.0||||||90.0|94.5|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102|94.5|
71025789|NCT01633827|141559129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
71108931|NCT00110214|141723330|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71108932|NCT00110214|141723331|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||<|0.001|TWO_SIDED|95.0|0.71|0.91||The primary analysis was adjusted for the stratification factors (24-mo survival probability as predicted by a validated nomogram (\<10%,10%-29.9%,\>=30%), age (\<65, \>=65 years) and prior history of arterial events (yes, no)).|Log Rank|||||0.91|0.71|<0.001
71108933|NCT03623698|141723333|OTHER||Median Difference (Final Values)|-2.5|||<|0.001|TWO_SIDED|95.0|-4.0|-1.5|||Wilcoxon (Mann-Whitney)|||"Statistical analysis was performed using IBM SPSS Statistics software, version 25.~This analysis applies to the category of Total courses of antibiotics."||-1.500|-4.000|<0.001
71108934|NCT03623698|141723333|OTHER|Linear mixed-effects model|Restricted Maximum Likelihood (REML)|-2.88||||0.001|TWO_SIDED|95.0|-4.46|-1.29||95% confidence interval, significance level p-values \<0.05. Random effects pre-defined from theory and published data, and AIC was were used to define the best model. Outcome measures: Courses of antibiotics; Fixed effect: nebulised saline treatment.|Mixed Models Analysis|Random effects: age, gender, mechanical ventilation, tracheostomy, gastrostomy, non-ambulant.||"Statistical analysis was performed using IBM SPSS Statistics software, version 25.~This analysis applies to the category of Total courses of antibiotics."||-1.29|-4.46|0.001
71108935|NCT03623698|141723334|OTHER||Median Difference (Final Values)|-1.0||||0.001|TWO_SIDED|95.0|-1.5|-0.5|||Wilcoxon (Mann-Whitney)|||Statistical analysis was performed using IBM SPSS Statistics software, version 25.||-0.50|-1.50|0.001
71108936|NCT03623698|141723334|OTHER||Restricted Maximum Likelihood (REML)|-1.02|||<|0.001|TWO_SIDED|95.0|-1.53|-0.52||95% confidence interval, significance level p-values \<0.05. Random effects pre-defined from theory and published data, and AIC was were used to define the best model. Outcome measures: Courses of antibiotics; Fixed effect: nebulised saline treatment.|Mixed Models Analysis|Random effects: age, gender, prolonged mechanical ventilation (nasal or tracheostomy), and antibiotic prophylaxis||Statistical analysis was performed using IBM SPSS Statistics software, version 25.||-0.52|-1.53|<0.001
71108937|NCT03623698|141723337|OTHER||Median Difference (Final Values)|-4.5||||0.003|TWO_SIDED|95.0|-5.5|-3.0|||Wilcoxon (Mann-Whitney)|||||-3.00|-5.50|0.003
71108938|NCT03623698|141723338|OTHER||Mean Difference (Final Values)|-2.0|||<|0.001|TWO_SIDED|95.0|-2.5|-2.0|||Wilcoxon (Mann-Whitney)|||||-2.0|-2.5|<0.001
71108939|NCT03623698|141723341|OTHER||Mean Difference (Final Values)|0.17||||0.97|TWO_SIDED|95.0|-0.69|0.76|||Wilcoxon (Mann-Whitney)|||||0.76|-0.69|0.97
71108940|NCT03623698|141723342|OTHER||Mean Difference (Final Values)|-1.47||||0.09|TWO_SIDED|95.0|-3.26|0.34|||Wilcoxon (Mann-Whitney)|||||0.34|-3.26|0.09
71108941|NCT03623698|141723343|OTHER||Mean Difference (Final Values)|-0.08||||0.65|TWO_SIDED|95.0|-0.38|0.38|||Wilcoxon (Mann-Whitney)|||||0.38|-0.38|0.65
70852041|NCT03158285|141192365|SUPERIORITY||Difference in response rates|18.0||||0.03|TWO_SIDED|95.0|7.4|28.6|||Cochran-Mantel-Haenszel|||||28.6|7.4|0.030
70852042|NCT03158285|141192365|SUPERIORITY||Difference in response rates|21.3||||0.011|TWO_SIDED|95.0|10.5|32.0|||Cochran-Mantel-Haenszel|||||32.0|10.5|0.011
70852043|NCT03158285|141192366|SUPERIORITY||LS Mean Difference|-0.5|||<|0.001|TWO_SIDED|95.0|-0.77|-0.23||Nominal|ANCOVA|||||-0.23|-0.77|< 0.001
70852044|NCT03158285|141192366|SUPERIORITY||LS Mean Difference|-0.57|||<|0.001|TWO_SIDED|95.0|-0.83|-0.31||Nominal|ANCOVA|||||-0.31|-0.83|< 0.001
70852045|NCT03158285|141192367|SUPERIORITY||LS Mean Difference|-1.89|||<|0.001|TWO_SIDED|95.0|-2.99|-0.79||Nominal|ANCOVA|||||-0.79|-2.99|< 0.001
70852046|NCT03158285|141192367|SUPERIORITY||LS Mean Difference|-1.77||||0.002|TWO_SIDED|95.0|-2.87|-0.66||Nominal|ANCOVA|||||-0.66|-2.87|0.002
71025790|NCT02637557|141559131|SUPERIORITY||LS Mean Difference|-2.952||||0.6065|TWO_SIDED|95.0|-14.222|8.318||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||8.318|-14.222|0.6065
71025791|NCT02637557|141559131|SUPERIORITY||LS Mean Difference|-9.036||||0.116|TWO_SIDED|95.0|-20.318|2.245||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||2.245|-20.318|0.1160
71025792|NCT02637557|141559131|SUPERIORITY||LS Mean Difference|-11.943||||0.04|TWO_SIDED|95.0|-23.334|-0.551||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||-0.551|-23.334|0.0400
71025793|NCT02637557|141559131|SUPERIORITY|||||||0.0225||||||Dose trend test performed using linear contrast statement.|trend test|||||||0.0225
71025794|NCT02637557|141559132|SUPERIORITY||LS Mean Difference|-3.711||||0.4795|TWO_SIDED|95.0|-14.028|6.606||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||6.606|-14.028|0.4795
71025795|NCT02637557|141559132|SUPERIORITY||LS Mean Difference|-2.739||||0.602|TWO_SIDED|95.0|-13.066|7.588||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||7.588|-13.066|0.6020
71025796|NCT02637557|141559132|SUPERIORITY||LS Mean Difference|-8.602||||0.1055|TWO_SIDED|95.0|-19.03|1.826||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||1.826|-19.030|0.1055
71025797|NCT02637557|141559132|SUPERIORITY|||||||0.1387||||||Dose trend test performed using linear contrast statement.|trend test|||||||0.1387
71025798|NCT02637557|141559133|SUPERIORITY||LS Mean Difference|-0.058||||0.7488|TWO_SIDED|95.0|-0.415|0.299||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.299|-0.415|0.7488
71025799|NCT02637557|141559133|SUPERIORITY||LS Mean Difference|-0.254||||0.1627|TWO_SIDED|95.0|-0.611|0.103||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.103|-0.611|0.1627
71025800|NCT02637557|141559133|SUPERIORITY||LS Mean Difference|-0.417||||0.0237|TWO_SIDED|95.0|-0.777|-0.056||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||-0.056|-0.777|0.0237
71025801|NCT02637557|141559133|SUPERIORITY|||||||0.013||||||Dose trend test performed using linear contrast statement.|trend test|||||||0.0130
71025802|NCT02637557|141559134|SUPERIORITY||LS Mean Difference|-0.052||||0.747|TWO_SIDED|95.0|-0.369|0.265||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.265|-0.369|0.7470
71025803|NCT02637557|141559134|SUPERIORITY||LS Mean Difference|-0.047||||0.7699|TWO_SIDED|95.0|-0.364|0.27||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.270|-0.364|0.7699
71025804|NCT02637557|141559134|SUPERIORITY||LS Mean Difference|-0.257||||0.1157|TWO_SIDED|95.0|-0.577|0.064||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.064|-0.577|0.1157
71025805|NCT02637557|141559134|SUPERIORITY|||||||0.1374||||||Dose trend test performed using linear contrast statement.|trend test|||||||0.1374
71108942|NCT00811954|141723348|NON_INFERIORITY_OR_EQUIVALENCE|Confidence interval estimation was stratified by HIV-1 RNA level at screening using Greenwood's variance with the inverse of this variance used for the stratum weights. The pre-specified confidence bounds for equivalence were +/-10 percentage points.|Cumulative probability difference|3.4|||||TWO_SIDED|97.5|-0.7|7.4||||||Treatment comparison was made using the difference (arm A - arm B) in the stratified Kaplan-Meier estimate for the week 96 cumulative probability of virologic failure with 97.5% confidence interval.||7.4|-0.7|
71108943|NCT00811954|141723348|NON_INFERIORITY_OR_EQUIVALENCE|Confidence interval estimation was stratified by HIV-1 RNA level at screening using Greenwood's variance with the inverse of this variance used for the stratum weights. The pre-specified confidence bounds for equivalence were +/-10 percentage points.|Cumulative probability difference|5.6|||||TWO_SIDED|97.5|1.3|9.9||||||Treatment comparison was made using the difference (arm C - arm B) in the stratified Kaplan-Meier estimate for the week 96 cumulative probability of virologic failure with 97.5% confidence interval.||9.9|1.3|
71108944|NCT00811954|141723348|NON_INFERIORITY_OR_EQUIVALENCE|Confidence interval estimation was stratified by HIV-1 RNA level at screening using Greenwood's variance with the inverse of this variance used for the stratum weights. The pre-specified confidence bounds for equivalence were +/-10 percentage points.|Cumulative probability difference|-2.2|||||TWO_SIDED|97.5|-6.7|2.3||||||Treatment comparison was made using the difference (arm A - arm C) in the stratified Kaplan-Meier estimate for the week 96 cumulative probability of virologic failure with 97.5% confidence interval.||2.3|-6.7|
71108945|NCT00811954|141723349|NON_INFERIORITY_OR_EQUIVALENCE|Although the study was not specifically powered to be able to detect equivalence, equivalence was declared if the 97.5% confidence interval difference in the cumulative probability of the tolerability endpoint by 96 weeks was entirely contained within +/-10 percentage points.|Cumulative incidence difference|12.8|||||TWO_SIDED|97.5|9.4|16.1||||||Treatment comparison was made using the methods of Gray. Inference regarding comparisons of the treatment groups (arm A and arm B) with respect to equivalence was made based on the two-sided 97.5% confidence intervals of differences (arm A - arm B) in 96 week probability of tolerability failure with 97.5% confidence interval.||16.1|9.4|
71108946|NCT00811954|141723349|NON_INFERIORITY_OR_EQUIVALENCE|Although the study was not specifically powered to be able to detect equivalence, equivalence was declared if the 97.5% confidence interval difference in the cumulative probability of the tolerability endpoint by 96 weeks was entirely contained within +/-10 percentage points.|Cumulative incidence difference|3.6|||||TWO_SIDED|97.5|1.4|5.8||||||Treatment comparison was made using the methods of Gray. Inference regarding comparisons of the treatment groups (arm C and arm B) with respect to equivalence was made based on the two-sided 97.5% confidence intervals of differences (arm C - arm B) in 96 week probability of tolerability failure with 97.5% confidence interval.||5.8|1.4|
71108947|NCT00811954|141723349|NON_INFERIORITY_OR_EQUIVALENCE|Although the study was not specifically powered to be able to detect equivalence, equivalence was declared if the 97.5% confidence interval difference in the cumulative probability of the tolerability endpoint by 96 weeks was entirely contained within +/-10 percentage points.|Cumulative incidence difference|9.2|||||TWO_SIDED|97.5|5.5|12.9||||||Treatment comparison was made using the methods of Gray. Inference regarding comparisons of the treatment groups (arm A and arm C) with respect to equivalence was made based on the two-sided 97.5% confidence intervals of differences (arm A - arm C) in 96 week probability of tolerability failure with 97.5% confidence interval.||12.9|5.5|
71108948|NCT05525910|141723404|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|105.03|||||TWO_SIDED|90.0|94.54|116.68||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) Low Disintegrant||116.68|94.54|
71108949|NCT05525910|141723404|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|109.15|||||TWO_SIDED|90.0|98.08|121.47||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) High Disintegrant||121.47|98.08|
71108950|NCT05525910|141723404|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|100.72|||||TWO_SIDED|90.0|90.79|111.74||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) HDL||111.74|90.79|
71108951|NCT05525910|141723404|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|110.45|||||TWO_SIDED|90.0|99.58|122.52||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 3\*(100/33.3 mg)||122.52|99.58|
71108952|NCT05525910|141723405|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|104.86|||||TWO_SIDED|90.0|93.78|117.24||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) Low Disintegrant||117.24|93.78|
71108953|NCT05525910|141723405|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|109.7|||||TWO_SIDED|90.0|97.93|122.89||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) High Disintegrant||122.89|97.93|
71108954|NCT05525910|141723405|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|100.14|||||TWO_SIDED|90.0|89.69|111.8||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) HDL||111.80|89.69|
71108955|NCT05525910|141723405|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|109.8|||||TWO_SIDED|90.0|98.36|122.57||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 3\*(100/33.3 mg)||122.57|98.36|
71025806|NCT02637557|141559135|SUPERIORITY||Odds Ratio (OR)|0.91||||0.7903|TWO_SIDED|95.0|0.47|1.77||Odds ratio, 95% confidence interval (CI) for the odds ratio and p-value vs. placebo are obtained from the Cochran-Mantel-Haenszel (CMH) tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||1.77|0.47|0.7903
71108956|NCT05525910|141723406|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|109.85|||||TWO_SIDED|90.0|94.97|127.06||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) Low Disintegrant||127.06|94.97|
70852047|NCT03158285|141192368|SUPERIORITY||LS Mean difference|3.97||||0.011|TWO_SIDED|95.0|2.75|5.2|||ANCOVA|||||5.20|2.75|0.011
71025807|NCT02637557|141559135|SUPERIORITY||Odds Ratio (OR)|1.38||||0.3518|TWO_SIDED|95.0|0.7|2.71||Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||2.71|0.70|0.3518
70935257|NCT00849485|141371238|NON_INFERIORITY_OR_EQUIVALENCE|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Geometric Test/Ref Ratio x 100|99.9||||||90.0|97.6|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102|97.6|
71108957|NCT05525910|141723406|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|114.69|||||TWO_SIDED|90.0|98.92|132.98||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) High Disintegrant||132.98|98.92|
70935258|NCT00849485|141371239|NON_INFERIORITY_OR_EQUIVALENCE|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|98.1|104.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104|98.1|
71108958|NCT05525910|141723406|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|109.26|||||TWO_SIDED|90.0|94.64|126.14||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) HDL||126.14|94.64|
71108959|NCT05525910|141723406|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|115.98|||||TWO_SIDED|90.0|100.48|133.87||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 3\*(100/33.3 mg)||133.87|100.48|
70935259|NCT02831816|141371240|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 cfu/cm2 less than the active control.|Median Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.221|0.18||||||Groin 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.180|-0.221|
70935260|NCT02831816|141371240|SUPERIORITY||Median Difference (Final Values)|2.45|||||TWO_SIDED|95.0|2.15|2.76||||||Groin 10 minutes Average Treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.76|2.15|
71025808|NCT02637557|141559135|SUPERIORITY||Odds Ratio (OR)|1.64||||0.1544|TWO_SIDED|95.0|0.83|3.26||Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||3.26|0.83|0.1544
71025809|NCT02637557|141559136|SUPERIORITY||Odds Ratio (OR)|0.56||||0.1489|TWO_SIDED|95.0|0.25|1.23||Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||1.23|0.25|0.1489
71025810|NCT02637557|141559136|SUPERIORITY||Odds Ratio (OR)|1.05||||0.8891|TWO_SIDED|95.0|0.51|2.19||Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||2.19|0.51|0.8891
71108960|NCT05525910|141723407|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|88.85|||||TWO_SIDED|90.0|76.24|103.53||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) Low Disintegrant||103.53|76.24|
71025811|NCT02637557|141559136|SUPERIORITY||Odds Ratio (OR)|1.56||||0.2237|TWO_SIDED|95.0|0.76|3.2||Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||3.20|0.76|0.2237
71025812|NCT02637557|141559137|SUPERIORITY||Odds Ratio (OR)|1.24||||0.6566|TWO_SIDED|95.0|0.48|3.18||Odds ratio, 95% CI (Confidence Interval) for the Odds Ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||3.18|0.48|0.6566
71108961|NCT05525910|141723407|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|95.11|||||TWO_SIDED|90.0|81.41|111.11||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) High Disintegrant||111.11|81.41|
71108962|NCT05525910|141723407|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|85.74|||||TWO_SIDED|90.0|73.73|99.7||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) HDL||99.70|73.73|
71108963|NCT05525910|141723407|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|93.12|||||TWO_SIDED|90.0|80.09|108.26||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 3\*(100/33.3 mg)||108.26|80.09|
71108964|NCT05525910|141723408|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|88.43|||||TWO_SIDED|90.0|74.64|104.78||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) Low Disintegrant||104.78|74.64|
71108965|NCT05525910|141723408|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|96.0|||||TWO_SIDED|90.0|80.8|114.06||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) High Disintegrant||114.06|80.80|
71108966|NCT05525910|141723408|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|84.11|||||TWO_SIDED|90.0|71.15|99.43||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) HDL||99.43|71.15|
70935261|NCT02831816|141371241|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 cfu/cm2 less than the active control.|Mean Difference (Final Values)|-0.0435|||||TWO_SIDED|95.0|-0.2085|0.1215||||||Abdomen 10 minutes average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.1215|-0.2085|
70935262|NCT02831816|141371241|SUPERIORITY||Mean Difference (Final Values)|1.97|||||TWO_SIDED|95.0|1.7|2.25||||||Abdomen 10 minutes Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.25|1.70|
71025813|NCT02637557|141559137|SUPERIORITY||Odds Ratio (OR)|2.01||||0.128|TWO_SIDED|95.0|0.81|4.98||Odds ratio, 95% CI (Confidence Interval) for the Odds Ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||4.98|0.81|0.1280
71025814|NCT02637557|141559137|SUPERIORITY||Odds Ratio (OR)|1.97||||0.1463|TWO_SIDED|95.0|0.79|4.91||Odds ratio, 95% CI (Confidence Interval) for the Odds Ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||4.91|0.79|0.1463
71025815|NCT02637557|141559138|SUPERIORITY||LS Mean Difference|-0.298||||0.5504|TWO_SIDED|95.0|-1.279|0.683||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.683|-1.279|0.5504
71025816|NCT02637557|141559138|SUPERIORITY||LS Mean Difference|0.252||||0.6177|TWO_SIDED|95.0|-0.741|1.244||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||1.244|-0.741|0.6177
71025817|NCT02637557|141559138|SUPERIORITY||LS Mean Difference|0.513||||0.3138|TWO_SIDED|95.0|-0.488|1.513||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||1.513|-0.488|0.3138
71025818|NCT02637557|141559139|SUPERIORITY||LS Mean Difference|0.019||||0.9675|TWO_SIDED|95.0|-0.897|0.935||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.935|-0.897|0.9675
71025819|NCT02637557|141559139|SUPERIORITY||LS Mean Difference|0.419||||0.3741|TWO_SIDED|95.0|-0.507|1.345||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||1.345|-0.507|0.3741
71025820|NCT02637557|141559139|SUPERIORITY||LS Mean Difference|0.461||||0.3275|TWO_SIDED|95.0|-0.464|1.385||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||1.385|-0.464|0.3275
71025821|NCT02637557|141559140|SUPERIORITY||LS Mean Difference|0.023||||0.856|TWO_SIDED|95.0|-0.226|0.272||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.272|-0.226|0.8560
70852048|NCT03158285|141192368|SUPERIORITY||LS Mean difference|3.62||||0.011|TWO_SIDED|95.0|2.39|4.85|||ANCOVA|||||4.85|2.39|0.011
70935263|NCT06943638|141371255|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
70935264|NCT01214200|141371284|OTHER|For the analysis of differences between pre and post treatment a student's t-test was used and was checked with the Wilcoxon signed rank test. A p\<0.05 was considered statistically significant.||||||0.01|||||||Wilcoxon Signed Ranks Test|||||||0.01
70935265|NCT01719172|141371292|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value from a one-sided exact test was based on the binomial distribution, testing that the true percent success rate was ≤ 50% versus the alternative hypothesis that the success rate was \> 50%.|t-test, 1 sided|||The primary effectiveness endpoint was the percent (%) success in obtaining hemostasis at the Target Bleeding Site (TBS) within 5 minutes following Veriset™ application. An exact (Clopper-Pearson) 95% confidence interval for the true success percentage was calculated. Subjects who received rescue therapy on the target bleeding site prior to obtaining hemostasis were considered failures.||||<0.0001
70941710|NCT04748445|141383935|OTHER||Slope|2.975|STANDARD_ERROR_OF_MEAN|3.383||0.3809|TWO_SIDED|90.0|-2.631|8.58|||Mixed Models Analysis|||EE\_Coefficient of Variation F0 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4.||8.580|-2.631|0.3809
71025822|NCT02637557|141559140|SUPERIORITY||LS Mean Difference|0.124||||0.3301|TWO_SIDED|95.0|-0.126|0.373||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.373|-0.126|0.3301
71025823|NCT02637557|141559140|SUPERIORITY||LS Mean Difference|-0.019||||0.8845|TWO_SIDED|95.0|-0.27|0.233||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.233|-0.270|0.8845
71025824|NCT02637557|141559140|SUPERIORITY||LS Mean Difference|0.02||||0.8879|TWO_SIDED|95.0|-0.262|0.303||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.303|-0.262|0.8879
71025825|NCT02637557|141559140|SUPERIORITY||LS Mean Difference|0.017||||0.9072|TWO_SIDED|95.0|-0.266|0.299||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.299|-0.266|0.9072
71025826|NCT02637557|141559140|SUPERIORITY||LS Mean Difference|-0.108||||0.4573|TWO_SIDED|95.0|-0.393|0.177||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.177|-0.393|0.4573
70852049|NCT03158285|141192369|SUPERIORITY||LS Mean difference|-0.61|||<|0.001|TWO_SIDED|95.0|-0.8|-0.43||Nominal|ANCOVA|||||-0.43|-0.80|< 0.001
71025827|NCT02637557|141559140|SUPERIORITY||LS Mean Difference|-0.049||||0.7476|TWO_SIDED|95.0|-0.35|0.251||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.251|-0.350|0.7476
71025828|NCT02637557|141559140|SUPERIORITY||LS Mean Difference|-0.062||||0.6873|TWO_SIDED|95.0|-0.362|0.239||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.239|-0.362|0.6873
71108967|NCT05525910|141723408|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|90.99|||||TWO_SIDED|90.0|76.99|107.54||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 3\*(100/33.3 mg)||107.54|76.99|
71025829|NCT02637557|141559140|SUPERIORITY||LS Mean Difference|-0.258||||0.0952|TWO_SIDED|95.0|-0.562|0.045||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.045|-0.562|0.0952
71025830|NCT02637557|141559140|SUPERIORITY||LS Mean Difference|-0.018||||0.9111|TWO_SIDED|95.0|-0.326|0.291||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.291|-0.326|0.9111
71025831|NCT02637557|141559140|SUPERIORITY||LS Mean Difference|0.004||||0.9772|TWO_SIDED|95.0|-0.304|0.313||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.313|-0.304|0.9772
71025832|NCT02637557|141559140|SUPERIORITY||LS Mean Difference|-0.235||||0.139|TWO_SIDED|95.0|-0.546|0.077||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.077|-0.546|0.1390
71025833|NCT02637557|141559140|SUPERIORITY||LS Mean Difference|-0.017||||0.9215|TWO_SIDED|95.0|-0.349|0.316||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.316|-0.349|0.9215
71025834|NCT02637557|141559140|SUPERIORITY||LS Mean Difference|-0.055||||0.7453|TWO_SIDED|95.0|-0.388|0.278||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.278|-0.388|0.7453
71025835|NCT02637557|141559140|SUPERIORITY||LS Mean Difference|-0.393||||0.022|TWO_SIDED|95.0|-0.729|-0.057||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||-0.057|-0.729|0.0220
71025836|NCT02637557|141559140|SUPERIORITY||LS Mean Difference|0.053||||0.7561|TWO_SIDED|95.0|-0.282|0.387||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.387|-0.282|0.7561
71025837|NCT02637557|141559140|SUPERIORITY||LS Mean Difference|-0.071||||0.6758|TWO_SIDED|95.0|-0.406|0.263||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.263|-0.406|0.6758
71025838|NCT02637557|141559140|SUPERIORITY||LS Mean Difference|-0.348||||0.0434|TWO_SIDED|95.0|-0.686|-0.01||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.010|-0.686|0.0434
71025839|NCT02637557|141559140|SUPERIORITY||LS Mean Difference|0.042||||0.8123|TWO_SIDED|95.0|-0.308|0.392||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.392|-0.308|0.8123
71025840|NCT02637557|141559140|SUPERIORITY||LS Mean Difference|-0.044||||0.8038|TWO_SIDED|95.0|-0.394|0.306||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.306|-0.394|0.8038
71025841|NCT02637557|141559140|SUPERIORITY||LS Mean Difference|-0.3||||0.0954|TWO_SIDED|95.0|-0.654|0.053||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.053|-0.654|0.0954
71025842|NCT02637557|141559140|SUPERIORITY||LS Mean Difference|-0.078||||0.6649|TWO_SIDED|95.0|-0.43|0.275||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.275|-0.430|0.6649
71025843|NCT02637557|141559140|SUPERIORITY||LS Mean Difference|-0.262||||0.1448|TWO_SIDED|95.0|-0.614|0.091||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.091|-0.614|0.1448
71025844|NCT02637557|141559140|SUPERIORITY||LS Mean Difference|-0.403||||0.0264|TWO_SIDED|95.0|-0.759|-0.048||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.048|-0.759|0.0264
71025845|NCT02637557|141559141|SUPERIORITY||LS Mean Difference|0.102||||0.4137|TWO_SIDED|95.0|-0.143|0.347||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.347|-0.143|0.4137
71108968|NCT05525910|141723409|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|82.65|||||TWO_SIDED|90.0|65.85|103.74||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) Low Disintegrant||103.74|65.85|
71108969|NCT05525910|141723409|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|94.85|||||TWO_SIDED|90.0|75.28|119.49||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) High Disintegrant||119.49|75.28|
71108970|NCT05525910|141723409|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|81.56|||||TWO_SIDED|90.0|65.18|102.07||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) HDL||102.07|65.18|
71108971|NCT05525910|141723409|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|88.38|||||TWO_SIDED|90.0|70.65|110.57||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 3\*(100/33.3 mg)||110.57|70.65|
71025846|NCT02637557|141559141|SUPERIORITY||LS Mean Difference|0.147||||0.2395|TWO_SIDED|95.0|-0.098|0.392||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.392|-0.098|0.2395
71108972|NCT02553629|141723450|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||||||0.001
71108973|NCT02553629|141723451|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71025847|NCT02637557|141559141|SUPERIORITY||LS Mean Difference|-0.036||||0.7729|TWO_SIDED|95.0|-0.284|0.212||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.212|-0.284|0.7729
71025848|NCT02637557|141559141|SUPERIORITY||LS Mean Difference|0.079||||0.5824|TWO_SIDED|95.0|-0.205|0.363||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.363|-0.205|0.5824
71025849|NCT02637557|141559141|SUPERIORITY||LS Mean Difference|0.028||||0.8466|TWO_SIDED|95.0|-0.256|0.312||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.312|-0.256|0.8466
71025850|NCT02637557|141559141|SUPERIORITY||LS Mean Difference|-0.118||||0.4192|TWO_SIDED|95.0|-0.405|0.169||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.169|-0.405|0.4192
71025851|NCT02637557|141559141|SUPERIORITY||LS Mean Difference|-0.035||||0.8192|TWO_SIDED|95.0|-0.333|0.264||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.264|-0.333|0.8192
71025852|NCT02637557|141559141|SUPERIORITY||LS Mean Difference|-0.073||||0.632|TWO_SIDED|95.0|-0.372|0.226||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.226|-0.372|0.6320
71025853|NCT02637557|141559141|SUPERIORITY||LS Mean Difference|-0.345||||0.0254|TWO_SIDED|95.0|-0.647|-0.043||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.043|-0.647|0.0254
71025854|NCT02637557|141559141|SUPERIORITY||LS Mean Difference|-0.047||||0.7689|TWO_SIDED|95.0|-0.36|0.266||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.266|-0.360|0.7689
71108974|NCT02553629|141723452|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
71108975|NCT02553629|141723453|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71025855|NCT02637557|141559141|SUPERIORITY||LS Mean Difference|-0.117||||0.4631|TWO_SIDED|95.0|-0.43|0.196||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.196|-0.430|0.4631
71025856|NCT02637557|141559141|SUPERIORITY||LS Mean Difference|-0.298||||0.0651|TWO_SIDED|95.0|-0.615|0.019||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.019|-0.615|0.0651
71108976|NCT02553629|141723454|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71108977|NCT01812057|141723455|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.740
71108978|NCT01812057|141723456|SUPERIORITY|Pain Score at rest at 2 hours||||||0.171|||||||t-test, 2 sided|||||||0.171
71108979|NCT01812057|141723456|SUPERIORITY|Pain Score with movement at 2 hours||||||0.204|||||||t-test, 2 sided|||||||0.204
71108980|NCT01812057|141723457|SUPERIORITY|||||||0.1965|||||||Log Rank|||||||0.1965
71108981|NCT01812057|141723458|SUPERIORITY|||||||0.709|||||||Wilcoxon (Mann-Whitney)|||||||0.709
71108982|NCT01812057|141723459|SUPERIORITY|Pain Score at rest at 24 hours||||||0.267|||||||Wilcoxon (Mann-Whitney)|||||||0.267
71108983|NCT01812057|141723459|SUPERIORITY|Pain Score with movement at 24 hours||||||0.518|||||||t-test, 2 sided|||||||0.518
71108984|NCT01812057|141723460|SUPERIORITY|Pain Score at rest at 48 hours||||||0.491|||||||Wilcoxon (Mann-Whitney)|||||||0.491
71108985|NCT01812057|141723460|SUPERIORITY|Pain Scores with movement at 48 hours||||||0.525|||||||Wilcoxon (Mann-Whitney)|||||||0.525
71117630|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
71108986|NCT01812057|141723461|SUPERIORITY|||||||0.355|||||||Wilcoxon (Mann-Whitney)|Total opioid consumption at 24 hours|||We also performed a multivariable regression analysis to determine factors associated with 24h opioid consumption accounting for MTS category, demographic factors, study group allocation (dexamethasone vs placebo) and a preoperative questions to assess patients anxiety, anticipated pain scores after surgery and anticipated analgesic need after surgery. At each step of backward variable selection, we eliminate the factor with the largest p-value over 0.05.In the final model MTS was not associated with 24h opioid consumption parameter estimate (standard error) = 9.15 (5.27), p=0.09.|||0.355
71108987|NCT01812057|141723462|SUPERIORITY|||||||0.42|||||||Fisher Exact|Chronic pain at 8 weeks||||||0.420
71108988|NCT01812057|141723463|SUPERIORITY|||||||0.322|||||||Fisher Exact|||||||0.322
70852050|NCT03158285|141192369|SUPERIORITY||LS Mean difference|-0.65|||<|0.001|TWO_SIDED|95.0|-0.83|-0.47||Nominal|ANCOVA|||||-0.47|-0.83|< 0.001
70852051|NCT03158285|141192370|SUPERIORITY||LS Mean difference|2.02||||0.072|TWO_SIDED|95.0|0.56|3.49|||ANCOVA|||||3.49|0.56|0.072
70852052|NCT03158285|141192370|SUPERIORITY||LS Mean difference|2.07||||0.072|TWO_SIDED|95.0|0.6|3.54|||ANCOVA|||||3.54|0.60|0.072
70852053|NCT03158285|141192371|SUPERIORITY||Difference in percentage|19.3|||<|0.001|TWO_SIDED|95.0|12.6|25.9||Nominal|Cochran-Mantel-Haenszel|||||25.9|12.6|< 0.001
70852054|NCT03158285|141192371|SUPERIORITY||Difference in percentage|11.5|||<|0.001|TWO_SIDED|95.0|5.2|17.7||Nominal|Cochran-Mantel-Haenszel|||||17.7|5.2|< 0.001
70852055|NCT03158285|141192372|SUPERIORITY||Difference in percentage|14.5|||<|0.001|TWO_SIDED|95.0|9.1|19.9||Nominal|Cochran-Mantel-Haenszel|||||19.9|9.1|< 0.001
70852056|NCT03158285|141192372|SUPERIORITY||Difference in percentage|9.0|||<|0.001|TWO_SIDED|95.0|4.1|13.8||Nominal|Cochran-Mantel-Haenszel|||||13.8|4.1|< 0.001
70852057|NCT00796926|141192579|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||>0.05
70852058|NCT00006289|141192595|SUPERIORITY_OR_OTHER|||||||0.0058|TWO_SIDED||||||t-test, 1 sided|||Data from 16 patients is analyzed using one-sided paired t-test without breaking treatment code (Drug A or B, without knowing which drug is Neurotropin or Placebo) to determine if (1) the study should be terminated (if 0.0058 ≤ p), (2) the study should be terminated with rejection of the null hypothesis that there are no differences between Drug A and Drug B (p ≥ 0.9), or (3) the study will be continued to obtain the total of 42 patients (0.0058 ≤ p ≤ 0.9).||||0.0058
70941711|NCT04748445|141383935|OTHER||Slope|-0.005601|STANDARD_ERROR_OF_MEAN|2.751||0.0438|TWO_SIDED|90.0|-0.01016|-0.001043|||Mixed Models Analysis|||EE\_MFCC 1st order delta 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3.||-0.001043|-0.01016|0.0438
71025857|NCT02637557|141559141|SUPERIORITY||LS Mean Difference|-0.06||||0.7197|TWO_SIDED|95.0|-0.392|0.271||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.271|-0.392|0.7197
71025858|NCT02637557|141559141|SUPERIORITY||LS Mean Difference|-0.097||||0.5649|TWO_SIDED|95.0|-0.428|0.234||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.234|-0.428|0.5649
71025859|NCT02637557|141559141|SUPERIORITY||LS Mean Difference|-0.422||||0.0138|TWO_SIDED|95.0|-0.757|-0.087||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||-0.087|-0.757|0.0138
71025860|NCT02637557|141559141|SUPERIORITY||LS Mean Difference|0.06||||0.7202|TWO_SIDED|95.0|-0.269|0.388||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.388|-0.269|0.7202
71025861|NCT02637557|141559141|SUPERIORITY||LS Mean Difference|-0.093||||0.5784|TWO_SIDED|95.0|-0.421|0.236||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.236|-0.421|0.5784
71025862|NCT02637557|141559141|SUPERIORITY||LS Mean Difference|-0.376||||0.0266|TWO_SIDED|95.0|-0.708|-0.044||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.044|-0.708|0.0266
71025863|NCT02637557|141559141|SUPERIORITY||LS Mean Difference|-0.049||||0.777|TWO_SIDED|95.0|-0.391|0.293||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.293|-0.391|0.7770
71025864|NCT02637557|141559141|SUPERIORITY||LS Mean Difference|-0.114||||0.5121|TWO_SIDED|95.0|-0.456|0.228||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.228|-0.456|0.5121
71025865|NCT02637557|141559141|SUPERIORITY||LS Mean Difference|-0.366||||0.0384|TWO_SIDED|95.0|-0.711|-0.02||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.020|-0.711|0.0384
71025866|NCT02637557|141559141|SUPERIORITY||LS Mean Difference|-0.093||||0.5876|TWO_SIDED|95.0|-0.431|0.245||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.245|-0.431|0.5876
71025867|NCT02637557|141559141|SUPERIORITY||LS Mean Difference|-0.298||||0.0842|TWO_SIDED|95.0|-0.636|0.04||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.040|-0.636|0.0842
71025868|NCT02637557|141559141|SUPERIORITY||LS Mean Difference|-0.452||||0.0098|TWO_SIDED|95.0|-0.793|-0.11||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.110|-0.793|0.0098
71025869|NCT02637557|141559142|SUPERIORITY||LS Mean Difference|0.054||||0.6663|TWO_SIDED|95.0|-0.193|0.301||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.301|-0.193|0.6663
71025870|NCT02637557|141559142|SUPERIORITY||LS Mean Difference|0.148||||0.24|TWO_SIDED|95.0|-0.1|0.396||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.396|-0.100|0.2400
71117631|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
70852059|NCT00006289|141192596|SUPERIORITY_OR_OTHER|||||||0.0058|TWO_SIDED||||||t-test, 1 sided|||Data from 16 patients is analyzed using one-sided paired t-test without breaking treatment code (Drug A or B) to determine if (1) the study should be terminated (if 0.0058 ≤ p), (2) the study should be terminated with rejection of the null hypothesis that there are no differences between Drug A and Drug B (p ≥ 0.9), or (3) the study will be continued to obtain the total of 42 patients (0.0058 ≤ p ≤ 0.9).||||0.0058
70852060|NCT00006289|141192597|SUPERIORITY_OR_OTHER|||||||0.0058|TWO_SIDED||||||t-test, 1 sided|||Data from 16 patients is analyzed using one-sided paired t-test without breaking treatment code (Drug A or B) to determine if (1) the study should be terminated (if 0.0058 ≤ p), (2) the study should be terminated with rejection of the null hypothesis that there are no differences between Drug A and Drug B (p ≥ 0.9), or (3) the study will be continued to obtain the total of 42 patients (0.0058 ≤ p ≤ 0.9).||||0.0058
71025871|NCT02637557|141559142|SUPERIORITY||LS Mean Difference|-0.023||||0.856|TWO_SIDED|95.0|-0.273|0.227||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.227|-0.273|0.8560
71025872|NCT02637557|141559142|SUPERIORITY||LS Mean Difference|0.051||||0.7209|TWO_SIDED|95.0|-0.232|0.335||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.335|-0.232|0.7209
71025873|NCT02637557|141559142|SUPERIORITY||LS Mean Difference|-0.013||||0.9283|TWO_SIDED|95.0|-0.297|0.271||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.271|-0.297|0.9283
71025874|NCT02637557|141559142|SUPERIORITY||LS Mean Difference|-0.162||||0.2659|TWO_SIDED|95.0|-0.449|0.124||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.124|-0.449|0.2659
71025875|NCT02637557|141559142|SUPERIORITY||LS Mean Difference|-0.006||||0.968|TWO_SIDED|95.0|-0.31|0.298||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.298|-0.310|0.9680
71025876|NCT02637557|141559142|SUPERIORITY||LS Mean Difference|-0.125||||0.4213|TWO_SIDED|95.0|-0.429|0.18||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.180|-0.429|0.4213
71025877|NCT02637557|141559142|SUPERIORITY||LS Mean Difference|-0.311||||0.0471|TWO_SIDED|95.0|-0.618|-0.004||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.004|-0.618|0.0471
71025878|NCT02637557|141559142|SUPERIORITY||LS Mean Difference|-0.025||||0.8769|TWO_SIDED|95.0|-0.337|0.288||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.288|-0.337|0.8769
71025879|NCT02637557|141559142|SUPERIORITY||LS Mean Difference|-0.059||||0.7109|TWO_SIDED|95.0|-0.372|0.254||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.254|-0.372|0.7109
71025880|NCT02637557|141559142|SUPERIORITY||LS Mean Difference|-0.254||||0.1146|TWO_SIDED|95.0|-0.57|0.062||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.062|-0.570|0.1146
71025881|NCT02637557|141559142|SUPERIORITY||LS Mean Difference|0.048||||0.7736|TWO_SIDED|95.0|-0.281|0.378||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.378|-0.281|0.7736
71025882|NCT02637557|141559142|SUPERIORITY||LS Mean Difference|-0.02||||0.9059|TWO_SIDED|95.0|-0.35|0.31||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.310|-0.350|0.9059
71025883|NCT02637557|141559142|SUPERIORITY||LS Mean Difference|-0.299||||0.0779|TWO_SIDED|95.0|-0.633|0.034||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.034|-0.633|0.0779
71025884|NCT02637557|141559142|SUPERIORITY||LS Mean Difference|0.086||||0.6068|TWO_SIDED|95.0|-0.241|0.412||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.412|-0.241|0.6068
71025885|NCT02637557|141559142|SUPERIORITY||LS Mean Difference|-0.024||||0.8838|TWO_SIDED|95.0|-0.352|0.303||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.303|-0.352|0.8838
71025886|NCT02637557|141559142|SUPERIORITY||LS Mean Difference|-0.323||||0.0556|TWO_SIDED|95.0|-0.653|0.008||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.008|-0.653|0.0556
70935266|NCT01719172|141371293|SUPERIORITY_OR_OTHER|||||||0.0214||||||The p-value from a one-sided exact test was based on the binomial distribution, testing that the true percent success rate was ≤ 50% versus the alternative hypothesis that the success rate was \> 50%.|t-test, 1 sided|||The number and percentage of subjects who achieved hemostasis within 1 minute were presented. An exact (Clopper-Pearson) 95% confidence interval for the true percentage was calculated.||||0.0214
70935267|NCT01719172|141371294|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.0|||||ONE_SIDED|95.0||1.0||||||Time to achieve hemostasis was analyzed using the Kaplan-Meier method to estimate the survival distribution and to obtain the estimated median time to hemostasis. Additionally, A 95% Brookmeyer-Crowley confidence interval for the median was computed based on the sign test.||1.0||
70935268|NCT00770874|141371295|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.125|TWO_SIDED|95.0|0.67|1.05|||Log Rank|||||1.05|0.67|0.125
70935269|NCT00770874|141371296|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.001|TWO_SIDED|95.0|0.48|0.8|||Log Rank|||||0.80|0.48|<0.001
71108989|NCT01812057|141723464|SUPERIORITY|||||||0.805|||||||Wilcoxon (Mann-Whitney)|||24 hour pain scores at rest between MTS groups|We also performed a multivariable regression analysis to determine factors associated with Pain scores at rest at 24 hours accounting for MTS category, demographic factors, study group allocation (dexamethasone vs placebo) and a preoperative questions to assess patients anxiety, anticipated pain scores after surgery and anticipated analgesic need after surgery. At each step of backward variable selection, we eliminate the factors with the largest p-value over 0.05. MTS category was not included in the final model for 24 h pain scores at rest.|||0.805
71108990|NCT01812057|141723464|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Pain scores on movement at 24h|We also performed a multivariable regression analysis to determine factors associated with Pain scores at rest at 24 hours accounting for MTS category, demographic factors, study group allocation (dexamethasone vs placebo) and a preoperative questions to assess patients anxiety, anticipated pain scores after surgery and anticipated analgesic need after surgery. At each step of backward variable selection, we eliminated the factors with the largest p-value over 0.05. MTS category was not included in the final model for 24 h pain scores on movement.|||1.000
71108991|NCT01812057|141723465|SUPERIORITY|Intraoperative nausea and vomiting||||||0.245|||||||Fisher Exact|||||||0.245
71108992|NCT01812057|141723465|SUPERIORITY|||||||0.676|||||||Chi-squared|Need for intraoperative antiemetics||||||0.676
70852061|NCT02043808|141192600|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.69|||||TWO_SIDED|95.0|0.52|0.92|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.92|0.52|
70935270|NCT03960645|141371322|OTHER||GLSM ratio (%)|41.24|||||TWO_SIDED|90.0|36.71|46.32||||||BIC: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% confidence interval (CI) was constructed for the geometric least squares mean (GLSM) ratio (%).||46.32|36.71|
70935271|NCT03960645|141371322|OTHER||GLSM ratio (%)|44.65|||||TWO_SIDED|90.0|40.04|49.79||||||BIC: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||49.79|40.04|
71025887|NCT02637557|141559142|SUPERIORITY||LS Mean Difference|-0.051||||0.7673|TWO_SIDED|95.0|-0.389|0.287||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.287|-0.389|0.7673
71025888|NCT02637557|141559142|SUPERIORITY||LS Mean Difference|-0.05||||0.7709|TWO_SIDED|95.0|-0.389|0.289||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.289|-0.389|0.7709
71025889|NCT02637557|141559142|SUPERIORITY||LS Mean Difference|-0.386||||0.0273|TWO_SIDED|95.0|-0.728|-0.043||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.043|-0.728|0.0273
71025890|NCT02637557|141559142|SUPERIORITY||LS Mean Difference|-0.044||||0.795|TWO_SIDED|95.0|-0.378|0.289||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.289|-0.378|0.7950
70935272|NCT03960645|141371322|OTHER||GLSM ratio (%)|40.57|||||TWO_SIDED|90.0|36.77|44.76||||||BIC: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||44.76|36.77|
70935273|NCT03960645|141371322|OTHER||GLSM ratio (%)|44.4|||||TWO_SIDED|90.0|39.95|49.34||||||BIC: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||49.34|39.95|
70935274|NCT03960645|141371323|OTHER||GLSM ratio (%)|67.38|||||TWO_SIDED|90.0|63.45|71.56||||||FTC: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||71.56|63.45|
71025891|NCT02637557|141559142|SUPERIORITY||LS Mean Difference|-0.236||||0.1656|TWO_SIDED|95.0|-0.57|0.098||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.098|-0.570|0.1656
70935275|NCT03960645|141371323|OTHER||GLSM ratio (%)|64.26|||||TWO_SIDED|90.0|60.95|67.75||||||FTC: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||67.75|60.95|
70935276|NCT03960645|141371323|OTHER||GLSM ratio (%)|69.19|||||TWO_SIDED|90.0|65.88|72.66||||||FTC: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||72.66|65.88|
70935277|NCT03960645|141371323|OTHER||GLSM ratio (%)|65.09|||||TWO_SIDED|90.0|61.79|68.57||||||FTC: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||68.57|61.79|
71025892|NCT02637557|141559142|SUPERIORITY||LS Mean Difference|-0.385||||0.0254|TWO_SIDED|95.0|-0.722|-0.048||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.048|-0.722|0.0254
71025893|NCT02637557|141559143|SUPERIORITY||LS Mean Difference|0.093||||0.3788|TWO_SIDED|95.0|-0.114|0.3||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.300|-0.114|0.3788
71108993|NCT01812057|141723465|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71108994|NCT01812057|141723467|SUPERIORITY|||||||0.924|||||||Chi-squared|Incidence of postoperative pruritus||||||0.924
71108995|NCT01812057|141723468|SUPERIORITY|||||||0.7|||||||Fisher Exact|||||||0.700
71108996|NCT01812057|141723469|SUPERIORITY|||||||0.302|||||||Chi-squared|Incidence of PONV at 24 h||||||0.302
71025894|NCT02637557|141559143|SUPERIORITY||LS Mean Difference|0.189||||0.0761|TWO_SIDED|95.0|-0.02|0.397||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.397|-0.020|0.0761
70852062|NCT02043808|141192601|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.83|||||TWO_SIDED|95.0|0.71|0.98|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.98|0.71|
70852063|NCT02043808|141192602|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.79|||||TWO_SIDED|95.0|0.59|1.07|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.07|0.59|
70852064|NCT02043808|141192603|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.31|||||TWO_SIDED|95.0|0.13|0.7|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.70|0.13|
71025895|NCT02637557|141559143|SUPERIORITY||LS Mean Difference|-0.021||||0.8415|TWO_SIDED|95.0|-0.232|0.189||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.189|-0.232|0.8415
71025896|NCT02637557|141559143|SUPERIORITY||LS Mean Difference|0.052||||0.6719|TWO_SIDED|95.0|-0.19|0.294||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.294|-0.190|0.6719
71025897|NCT02637557|141559143|SUPERIORITY||LS Mean Difference|0.007||||0.9549|TWO_SIDED|95.0|-0.237|0.251||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.251|-0.237|0.9549
71025898|NCT02637557|141559143|SUPERIORITY||LS Mean Difference|-0.096||||0.4408|TWO_SIDED|95.0|-0.342|0.149||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.149|-0.342|0.4408
71025899|NCT02637557|141559143|SUPERIORITY||LS Mean Difference|-0.004||||0.9736|TWO_SIDED|95.0|-0.262|0.253||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.253|-0.262|0.9736
71025900|NCT02637557|141559143|SUPERIORITY||LS Mean Difference|-0.146||||0.2703|TWO_SIDED|95.0|-0.405|0.114||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.114|-0.405|0.2703
71025901|NCT02637557|141559143|SUPERIORITY||LS Mean Difference|-0.351||||0.0087|TWO_SIDED|95.0|-0.612|-0.089||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.089|-0.612|0.0087
71025902|NCT02637557|141559143|SUPERIORITY||LS Mean Difference|-0.026||||0.848|TWO_SIDED|95.0|-0.295|0.243||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.243|-0.295|0.8480
71025903|NCT02637557|141559143|SUPERIORITY||LS Mean Difference|-0.073||||0.5966|TWO_SIDED|95.0|-0.344|0.198||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.198|-0.344|0.5966
71025904|NCT02637557|141559143|SUPERIORITY||LS Mean Difference|-0.324||||0.0203|TWO_SIDED|95.0|-0.596|-0.051||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||-0.051|-0.596|0.0203
71025905|NCT02637557|141559143|SUPERIORITY||LS Mean Difference|-0.025||||0.854|TWO_SIDED|95.0|-0.294|0.244||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.244|-0.294|0.8540
71025906|NCT02637557|141559143|SUPERIORITY||LS Mean Difference|-0.022||||0.8757|TWO_SIDED|95.0|-0.293|0.25||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.250|-0.293|0.8757
71025907|NCT02637557|141559143|SUPERIORITY||LS Mean Difference|-0.332||||0.0174|TWO_SIDED|95.0|-0.605|-0.059||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||-0.059|-0.605|0.0174
71025908|NCT02637557|141559143|SUPERIORITY||LS Mean Difference|0.078||||0.5831|TWO_SIDED|95.0|-0.202|0.358||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.358|-0.202|0.5831
71025909|NCT02637557|141559143|SUPERIORITY||LS Mean Difference|-0.078||||0.5859|TWO_SIDED|95.0|-0.36|0.204||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.204|-0.360|0.5859
71025910|NCT02637557|141559143|SUPERIORITY||LS Mean Difference|-0.291||||0.0447|TWO_SIDED|95.0|-0.575|-0.007||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.007|-0.575|0.0447
71025911|NCT02637557|141559143|SUPERIORITY||LS Mean Difference|0.093||||0.5365|TWO_SIDED|95.0|-0.203|0.388||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.388|-0.203|0.5365
70852065|NCT02043808|141192604|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.48|||||TWO_SIDED|95.0|0.3|0.77|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.77|0.30|
70852066|NCT02043808|141192605|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.9|||||TWO_SIDED|95.0|0.76|1.07|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.07|0.76|
70852067|NCT02043808|141192606|SUPERIORITY_OR_OTHER||Crude event rate ratio|1.07|||||TWO_SIDED|95.0|0.89|1.3|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.30|0.89|
71025912|NCT02637557|141559143|SUPERIORITY||LS Mean Difference|-0.057||||0.7067|TWO_SIDED|95.0|-0.355|0.241||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.241|-0.355|0.7067
70852068|NCT02043808|141192607|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.72|||||TWO_SIDED|95.0|0.5|1.03|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.03|0.50|
70852069|NCT02043808|141192608|SUPERIORITY_OR_OTHER||Crude event rate ratio|1.24|||||TWO_SIDED|95.0|0.99|1.54|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.54|0.99|
70852070|NCT02043808|141192609|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.35|||||TWO_SIDED|95.0|0.17|0.72|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.72|0.17|
71108997|NCT01812057|141723469|SUPERIORITY|||||||0.028|||||||Chi-squared|Postoperative need for rescue antiemetic||||||0.028
70852071|NCT02043808|141192610|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.37|||||TWO_SIDED|95.0|0.22|0.64|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.64|0.22|
70852072|NCT02043808|141192611|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.83|||||TWO_SIDED|95.0|0.55|1.26|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.26|0.55|
70852073|NCT02043808|141192612|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.66|||||TWO_SIDED|95.0|0.45|0.95|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.95|0.45|
71025913|NCT02637557|141559143|SUPERIORITY||LS Mean Difference|-0.317||||0.0386|TWO_SIDED|95.0|-0.616|-0.017||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.017|-0.616|0.0386
71025914|NCT02637557|141559143|SUPERIORITY||LS Mean Difference|0.042||||0.7804|TWO_SIDED|95.0|-0.253|0.336||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.336|-0.253|0.7804
71025915|NCT02637557|141559143|SUPERIORITY||LS Mean Difference|-0.125||||0.4064|TWO_SIDED|95.0|-0.422|0.171||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.171|-0.422|0.4064
71025916|NCT02637557|141559143|SUPERIORITY||LS Mean Difference|-0.333||||0.0289|TWO_SIDED|95.0|-0.632|-0.035||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.035|-0.632|0.0289
71025917|NCT02637557|141559144|SUPERIORITY||LS Mean Difference|0.037||||0.7207|TWO_SIDED|95.0|-0.167|0.241||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.241|-0.167|0.7207
71025918|NCT02637557|141559144|SUPERIORITY||LS Mean Difference|-0.071||||0.4946|TWO_SIDED|95.0|-0.275|0.133||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.133|-0.275|0.4946
71025919|NCT02637557|141559144|SUPERIORITY||LS Mean Difference|-0.077||||0.4596|TWO_SIDED|95.0|-0.283|0.129||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.129|-0.283|0.4596
71025920|NCT02637557|141559144|SUPERIORITY||LS Mean Difference|0.067||||0.5987|TWO_SIDED|95.0|-0.182|0.315||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.315|-0.182|0.5987
71025921|NCT02637557|141559144|SUPERIORITY||LS Mean Difference|-0.122||||0.3348|TWO_SIDED|95.0|-0.372|0.127||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.127|-0.372|0.3348
71025922|NCT02637557|141559144|SUPERIORITY||LS Mean Difference|-0.062||||0.6288|TWO_SIDED|95.0|-0.313|0.19||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.190|-0.313|0.6288
71025923|NCT02637557|141559144|SUPERIORITY||LS Mean Difference|-0.048||||0.7193|TWO_SIDED|95.0|-0.312|0.216||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.216|-0.312|0.7193
71025924|NCT02637557|141559144|SUPERIORITY||LS Mean Difference|-0.27||||0.0452|TWO_SIDED|95.0|-0.534|-0.006||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.006|-0.534|0.0452
71025925|NCT02637557|141559144|SUPERIORITY||LS Mean Difference|-0.252||||0.0635|TWO_SIDED|95.0|-0.519|0.014||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.014|-0.519|0.0635
71025926|NCT02637557|141559144|SUPERIORITY||LS Mean Difference|-0.126||||0.38|TWO_SIDED|95.0|-0.409|0.156||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.156|-0.409|0.3800
71025927|NCT02637557|141559144|SUPERIORITY||LS Mean Difference|-0.336||||0.02|TWO_SIDED|95.0|-0.62|-0.053||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||-0.053|-0.620|0.0200
71025928|NCT02637557|141559144|SUPERIORITY||LS Mean Difference|-0.328||||0.0244|TWO_SIDED|95.0|-0.614|-0.043||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||-0.043|-0.614|0.0244
71025929|NCT02637557|141559144|SUPERIORITY||LS Mean Difference|-0.096||||0.5232|TWO_SIDED|95.0|-0.392|0.2||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.200|-0.392|0.5232
71108998|NCT01812057|141723469|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71108999|NCT01812057|141723469|SUPERIORITY|||||||0.188|||||||Chi-squared|||||||0.188
71109000|NCT03937479|141723508|SUPERIORITY||LS mean difference|0.1242|STANDARD_ERROR_OF_MEAN|0.03691||0.0008|TWO_SIDED|95.0|0.0517|0.1968||The mixed model for repeated measures (MMRM) model was used to model the change from baseline FEV1 to peak FEV1 using treatment, visit and treatment by visit interaction as fixed effect, patient as random effect and baseline FEV1 as the covariate.|MMRM||Estimates refer to the Week 4 from treatment by visit interaction.|Comparison was done using a closed testing procedure; testing began at the highest dose of RPL554 compared with placebo. If found statistically significant then the next highest dose was compared with placebo. This continued until a result was found to be non-significant or all RPL554 doses were compared with placebo.||0.1968|0.0517|0.0008
71109001|NCT03937479|141723508|SUPERIORITY||LS mean difference|0.1072|STANDARD_ERROR_OF_MEAN|0.03703||0.004|TWO_SIDED|95.0|0.0344|0.18||The MMRM model was used to model the change from baseline FEV1 to peak FEV1 using treatment, visit and treatment by visit interaction as fixed effect, patient as random effect and baseline FEV1 as the covariate.|MMRM||Estimates refer to the Week 4 from treatment by visit interaction.|Comparison was done using a closed testing procedure; testing began at the highest dose of RPL554 compared with placebo. If found statistically significant then the next highest dose was compared with placebo. This continued until a result was found to be non-significant or all RPL554 doses were compared with placebo.||0.1800|0.0344|0.0040
71109002|NCT03937479|141723508|SUPERIORITY||LS mean difference|0.0912|STANDARD_ERROR_OF_MEAN|0.03723||0.0148|TWO_SIDED|95.0|0.018|0.1643||The MMRM model was used to model the change from baseline FEV1 to peak FEV1 using treatment, visit and treatment by visit interaction as fixed effect, patient as random effect and baseline FEV1 as the covariate.|MMRM||Estimates refer to the Week 4 from treatment by visit interaction.|Comparison was done using a closed testing procedure; testing began at the highest dose of RPL554 compared with placebo. If found statistically significant then the next highest dose was compared with placebo. This continued until a result was found to be non-significant or all RPL554 doses were compared with placebo.||0.1643|0.0180|0.0148
71109003|NCT03937479|141723508|SUPERIORITY||LS mean difference|0.0775|STANDARD_ERROR_OF_MEAN|0.03697||0.0368|TWO_SIDED|95.0|0.0048|0.1501||The MMRM model was used to model the change from baseline FEV1 to peak FEV1 using treatment, visit and treatment by visit interaction as fixed effect, patient as random effect and baseline FEV1 as the covariate.|MMRM||Estimates refer to the Week 4 from treatment by visit interaction.|Comparison was done using a closed testing procedure; testing began at the highest dose of RPL554 compared with placebo. If found statistically significant then the next highest dose was compared with placebo. This continued until a result was found to be non-significant or all RPL554 doses were compared with placebo.||0.1501|0.0048|0.0368
71109004|NCT01854528|141723540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.26|||<|0.001|TWO_SIDED|95.0|21.09|47.42|||Stratum adjusted Mantel-Haenszel|||P-value for the difference in sustained virologic response rates 12 weeks after the last dose between treatment groups with HCV subgenotype (1a, non-1a) from stratum adjusted Mantel-Haenszel with previous type of response to pegIFN/RBV treatment (relapser, partial or null responder) as strata.||47.42|21.09|<0.001
71109005|NCT01854528|141723541|SUPERIORITY_OR_OTHER||LS mean difference|8.64|||<|0.001|TWO_SIDED|95.0|5.43|11.85|||ANCOVA|||P-value from ANCOVA model including baseline score and region as covariates and treatment arm as a factor.||11.85|5.43|<0.001
71109006|NCT01854528|141723542|SUPERIORITY_OR_OTHER||LS mean difference|7.55|||<|0.001|TWO_SIDED|95.0|5.11|9.98|||ANCOVA|||P-value from ANCOVA model including baseline score and region as covariates and treatment arm as a factor.||9.98|5.11|<0.001
71109007|NCT01854528|141723543|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|54.7|||<|0.001|TWO_SIDED|95.0|6.9|435.1|||Regression, Logistic|||P-value from logistic regression model including treatment arm, baseline log10 HCV RNA level, HCV subgenotype, and previous response to pegIFN/RBV treatment as predictors.||435.1|6.9|<0.001
70935278|NCT03960645|141371323|OTHER||GLSM ratio (%)|77.62|||||TWO_SIDED|90.0|65.4|92.14||||||TAF: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||92.14|65.40|
71109008|NCT00811720|141723568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33|STANDARD_ERROR_OF_MEAN|0.75||0.002|TWO_SIDED|95.0|-3.81|-0.85|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 213 participants in the placebo group and 152 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. The null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-6); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."||-0.85|-3.81|0.002
70935279|NCT03960645|141371323|OTHER||GLSM ratio (%)|62.5|||||TWO_SIDED|90.0|50.76|76.96||||||TAF: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||76.96|50.76|
70935280|NCT03960645|141371323|OTHER||GLSM ratio (%)|69.67|||||TWO_SIDED|90.0|58.57|82.88||||||TAF: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||82.88|58.57|
70935281|NCT03960645|141371323|OTHER||GLSM ratio (%)|56.52|||||TWO_SIDED|90.0|46.32|68.96||||||TAF: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||68.96|46.32|
71025930|NCT02637557|141559144|SUPERIORITY||LS Mean Difference|-0.282||||0.0623|TWO_SIDED|95.0|-0.579|0.015||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.015|-0.579|0.0623
71025931|NCT02637557|141559144|SUPERIORITY||LS Mean Difference|-0.255||||0.0951|TWO_SIDED|95.0|-0.554|0.045||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.045|-0.554|0.0951
70935282|NCT03960645|141371325|OTHER||GLSM ratio (%)|51.91|||||TWO_SIDED|90.0|46.48|57.97||||||BIC: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||57.97|46.48|
71109009|NCT00811720|141723569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.96|STANDARD_ERROR_OF_MEAN|2.98|<|0.001|TWO_SIDED|95.0|-16.81|-5.11|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 213 participants in the placebo group and 152 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. The null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-6); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."||-5.11|-16.81|<0.001
71109010|NCT00811720|141723570|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.039|TWO_SIDED|95.0|0.5|0.98|||Adjusted Odds Ratio (OR) response|||The analysis of RSDRL used a logistic regression (LREG) model, with country, sex, Baseline DRL, and treatment as fixed effects, and missing values imputed as non-response.||0.98|0.50|0.039
71109011|NCT00811720|141723571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.57|-0.16|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 210 participants in the placebo group and 152 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model; an unstructured covariance matrix was used.||-0.16|-0.57|<0.001
71109012|NCT00811720|141723572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.53|-0.15|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 210 participants in the placebo group and 152 participants in the nalmefene group.|MMRM model with the Baseline CGI-S score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline CGI-S score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used.||-0.15|-0.53|<0.001
71109013|NCT00811720|141723573|SUPERIORITY_OR_OTHER||Ratio to placebo|0.88||||0.009|TWO_SIDED|95.0|0.8|0.97|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 211 participants in the placebo group and 158 participants in the nalmefene group.|Log-transformed GGT values were analysed using an MMRM model with the log-transformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time interaction and treatment-by-time interaction were included in the model. An unstructured covariance matrix was used.||0.97|0.80|0.009
71109014|NCT00811720|141723574|SUPERIORITY_OR_OTHER||Ratio to placebo|0.9||||0.011|TWO_SIDED|95.0|0.84|0.98|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 209 participants in the placebo group and 158 participants in the nalmefene group.|Log-transformed ALAT values were analysed using an MMRM model with the log-transformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time and treatment-by-time interactions were included in the model. An unstructured covariance matrix was used.||0.98|0.84|0.011
71109015|NCT02099084|141723636|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||t-test, 2 sided|||Level of significance = .05||||0.74
71109016|NCT02099084|141723637|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||t-test, 2 sided|||Comparison between the groups for change between 0- and 2-hours. Level of significance = .05||||0.20
71109017|NCT02099084|141723637|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||t-test, 2 sided|||Comparison between the groups for change between 0- and 8-hours. Level of significance = .05||||0.17
70935283|NCT03960645|141371325|OTHER||GLSM ratio (%)|57.67|||||TWO_SIDED|90.0|52.48|63.36||||||BIC: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||63.36|52.48|
70935284|NCT03960645|141371325|OTHER||GLSM ratio (%)|48.18|||||TWO_SIDED|90.0|43.03|53.94||||||BIC: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||53.94|43.03|
70935285|NCT03960645|141371325|OTHER||GLSM ratio (%)|54.42|||||TWO_SIDED|90.0|48.39|61.21||||||BIC: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||61.21|48.39|
70935286|NCT03960645|141371325|OTHER||GLSM ratio (%)|75.61|||||TWO_SIDED|90.0|66.7|85.7||||||FTC: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||85.70|66.70|
71109018|NCT02099084|141723638|SUPERIORITY_OR_OTHER|||||||0.075|TWO_SIDED||||||t-test, 2 sided|||Level of significance = .05||||0.075
71109019|NCT02099084|141723641|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED||||||t-test, 2 sided|||Level of significance = .05||||0.42
71109020|NCT02099084|141723642|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||t-test, 2 sided|||Level of significance = .05||||0.34
71109021|NCT01205503|141723643|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED|||||This is for the interaction between baseline tnf-alpha levels and treatment received (mesna vs saline).|Mixed Models Analysis|Model was adjusted for baseline biochemical measures, time of measurement, treatment (mesna or saline), chemo type, and first-order interactions.||||||0.014
71109022|NCT01953211|141723655|SUPERIORITY_OR_OTHER||Slope|0.02|STANDARD_DEVIATION|0.57||0.88|TWO_SIDED||||||t-test, 2 sided|||||||0.88
71109023|NCT01953211|141723655|SUPERIORITY_OR_OTHER||Slope|0.63|STANDARD_DEVIATION|0.9|<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
71109024|NCT01953211|141723655|SUPERIORITY_OR_OTHER||Slope|0.83|STANDARD_DEVIATION|0.78|<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
71109025|NCT03188263|141723656|OTHER|The primary planned analysis was in bright light group only and compared pre-post measurements.||||||0.046||||||A threshold of .05 was selected a priori.|Sign test|A Wilcoxon matched-pairs signed-ranks test was estimated to determine if pre-post measures of glucose levels differed significantly.||The primary planned analyses was to examine effect in bright light group. A significance level of .05 was selected a priori.||||.046
71058537|NCT00486525|141622949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.99||0.21|TWO_SIDED|95.0|-3.2|0.69|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||0.69|-3.2|0.21
71025932|NCT02637557|141559144|SUPERIORITY||LS Mean Difference|-0.06||||0.6985|TWO_SIDED|95.0|-0.363|0.243||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.243|-0.363|0.6985
71025933|NCT02637557|141559144|SUPERIORITY||LS Mean Difference|-0.373||||0.0163|TWO_SIDED|95.0|-0.677|-0.069||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.069|-0.677|0.0163
71025934|NCT02637557|141559144|SUPERIORITY||LS Mean Difference|-0.345||||0.0273|TWO_SIDED|95.0|-0.652|-0.039||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.039|-0.652|0.0273
71025935|NCT02637557|141559144|SUPERIORITY||LS Mean Difference|-0.056||||0.7187|TWO_SIDED|95.0|-0.362|0.25||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.250|-0.362|0.7187
71025936|NCT02637557|141559144|SUPERIORITY||LS Mean Difference|-0.29||||0.064|TWO_SIDED|95.0|-0.596|0.017||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.017|-0.596|0.0640
71025937|NCT02637557|141559144|SUPERIORITY||LS Mean Difference|-0.484||||0.0023|TWO_SIDED|95.0|-0.793|-0.175||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.175|-0.793|0.0023
71025938|NCT02637557|141559144|SUPERIORITY||LS Mean Difference|-0.079||||0.6033|TWO_SIDED|95.0|-0.378|0.22||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.220|-0.378|0.6033
71025939|NCT02637557|141559144|SUPERIORITY||LS Mean Difference|-0.35||||0.0222|TWO_SIDED|95.0|-0.65|-0.05||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.050|-0.650|0.0222
71025940|NCT02637557|141559144|SUPERIORITY||LS Mean Difference|-0.482||||0.0019|TWO_SIDED|95.0|-0.785|-0.18||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.180|-0.785|0.0019
71025941|NCT02637557|141559145|SUPERIORITY||LS Mean Difference|0.143||||0.1922|TWO_SIDED|95.0|-0.072|0.357||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.357|-0.072|0.1922
71025942|NCT02637557|141559145|SUPERIORITY||LS Mean Difference|0.072||||0.5091|TWO_SIDED|95.0|-0.143|0.288||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.288|-0.143|0.5091
71025943|NCT02637557|141559145|SUPERIORITY||LS Mean Difference|0.037||||0.7394|TWO_SIDED|95.0|-0.181|0.254||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.254|-0.181|0.7394
71025944|NCT02637557|141559145|SUPERIORITY||LS Mean Difference|0.073||||0.5845|TWO_SIDED|95.0|-0.189|0.334||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.334|-0.189|0.5845
71025945|NCT02637557|141559145|SUPERIORITY||LS Mean Difference|-0.034||||0.7959|TWO_SIDED|95.0|-0.296|0.228||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.228|-0.296|0.7959
70852074|NCT02043808|141192613|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.64|||||TWO_SIDED|95.0|0.31|1.31|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.31|0.31|
70852075|NCT02043808|141192614|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.44|||||TWO_SIDED|95.0|0.16|1.21|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.21|0.16|
71025946|NCT02637557|141559145|SUPERIORITY||LS Mean Difference|-0.015||||0.9086|TWO_SIDED|95.0|-0.28|0.249||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.249|-0.280|0.9086
71025947|NCT02637557|141559145|SUPERIORITY||LS Mean Difference|-0.08||||0.5334|TWO_SIDED|95.0|-0.333|0.173||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.173|-0.333|0.5334
71025948|NCT02637557|141559145|SUPERIORITY||LS Mean Difference|-0.212||||0.102|TWO_SIDED|95.0|-0.466|0.042||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.042|-0.466|0.1020
71025949|NCT02637557|141559145|SUPERIORITY||LS Mean Difference|-0.357||||0.0066|TWO_SIDED|95.0|-0.613|-0.1||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.100|-0.613|0.0066
70935287|NCT03960645|141371325|OTHER||GLSM ratio (%)|77.81|||||TWO_SIDED|90.0|68.76|88.05||||||FTC: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||88.05|68.76|
70935288|NCT03960645|141371325|OTHER||GLSM ratio (%)|77.45|||||TWO_SIDED|90.0|70.33|85.29||||||FTC: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||85.29|70.33|
70935289|NCT03960645|141371325|OTHER||GLSM ratio (%)|77.08|||||TWO_SIDED|90.0|69.78|85.15||||||FTC: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||85.15|69.78|
70935290|NCT03960645|141371325|OTHER||GLSM ratio (%)|69.9|||||TWO_SIDED|90.0|56.16|87.0||||||TAF: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||87.00|56.16|
71025950|NCT02637557|141559145|SUPERIORITY||LS Mean Difference|-0.127||||0.3586|TWO_SIDED|95.0|-0.399|0.145||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.145|-0.399|0.3586
71025951|NCT02637557|141559145|SUPERIORITY||LS Mean Difference|-0.348||||0.0128|TWO_SIDED|95.0|-0.621|-0.075||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||-0.075|-0.621|0.0128
71025952|NCT02637557|141559145|SUPERIORITY||LS Mean Difference|-0.384||||0.0064|TWO_SIDED|95.0|-0.66|-0.109||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||-0.109|-0.660|0.0064
71025953|NCT02637557|141559145|SUPERIORITY||LS Mean Difference|-0.076||||0.6124|TWO_SIDED|95.0|-0.369|0.218||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.218|-0.369|0.6124
71058538|NCT00486525|141622949|SUPERIORITY_OR_OTHER||Slope|-0.66|STANDARD_ERROR_OF_MEAN|0.34||0.051|TWO_SIDED|95.0|-1.3|0.0039|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of CES-D for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||0.0039|-1.3|0.051
71058539|NCT00486525|141622949|SUPERIORITY_OR_OTHER||Slope|-0.56|STANDARD_ERROR_OF_MEAN|0.34||0.098|TWO_SIDED|95.0|-1.2|0.1|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of CESD for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||0.10|-1.2|0.098
71058540|NCT03573830|141622953|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.002|TWO_SIDED|95.0|0.04|0.2||Threshold for significance: \<0.05|t-test, 2 sided|||||0.20|0.04|0.002
71058541|NCT03573830|141622954|SUPERIORITY||Mean Difference (Final Values)|0.15||||0|TWO_SIDED|95.0|0.07|0.22||Threshold for significance: 0.05|t-test, 2 sided|||||0.22|0.07|0.000
71058542|NCT03573830|141622955|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.352|TWO_SIDED|95.0|-0.03|0.07||Threshold for significance: 0.05|t-test, 2 sided|||||0.07|-0.03|0.352
70852076|NCT02043808|141192615|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.97|||||TWO_SIDED|95.0|0.34|2.81|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||2.81|0.34|
70935291|NCT03960645|141371325|OTHER||GLSM ratio (%)|66.55|||||TWO_SIDED|90.0|53.79|82.34||||||TAF: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||82.34|53.79|
70935292|NCT03960645|141371325|OTHER||GLSM ratio (%)|57.14|||||TWO_SIDED|90.0|46.04|70.91||||||TAF: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||70.91|46.04|
70935293|NCT03960645|141371325|OTHER||GLSM ratio (%)|55.27|||||TWO_SIDED|90.0|44.65|68.42||||||TAF: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||68.42|44.65|
70935294|NCT03960645|141371326|OTHER||GLSM ratio (%)|26.17|||||TWO_SIDED|90.0|21.45|31.93||||||BIC: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||31.93|21.45|
70935295|NCT03960645|141371326|OTHER||GLSM ratio (%)|26.99|||||TWO_SIDED|90.0|22.23|32.78||||||BIC: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||32.78|22.23|
71058543|NCT03573830|141622956|SUPERIORITY||Mean Difference (Final Values)|0.45||||0|TWO_SIDED|95.0|0.34|0.56||Threshold for significance: \<0.05|t-test, 2 sided|||||0.56|0.34|0.000
71058544|NCT03573830|141622957|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.002|TWO_SIDED|95.0|0.05|0.22||Threshold for significance: 0.05|t-test, 2 sided|||||0.22|0.05|0.002
71058545|NCT03573830|141622958|SUPERIORITY||Mean Difference (Final Values)|32.56||||0.033|TWO_SIDED|95.0|2.65|62.46||Threshold for significance: \<0.05|t-test, 2 sided|||||62.46|2.65|0.033
70935296|NCT03960645|141371326|OTHER||GLSM ratio (%)|29.03|||||TWO_SIDED|90.0|25.74|32.74||||||BIC: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||32.74|25.74|
70935297|NCT03960645|141371326|OTHER||GLSM ratio (%)|29.97|||||TWO_SIDED|90.0|26.47|33.93||||||BIC: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||33.93|26.47|
70935298|NCT03960645|141371326|OTHER||GLSM ratio (%)|64.22|||||TWO_SIDED|90.0|54.63|75.49||||||FTC: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||75.49|54.63|
70935299|NCT03960645|141371326|OTHER||GLSM ratio (%)|42.89|||||TWO_SIDED|90.0|36.55|50.34||||||FTC: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||50.34|36.55|
71025954|NCT02637557|141559145|SUPERIORITY||LS Mean Difference|-0.223||||0.1365|TWO_SIDED|95.0|-0.518|0.071||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.071|-0.518|0.1365
71058546|NCT03573830|141622960|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.065|TWO_SIDED|95.0|0.0|0.19||Threshold for significance: \<0.05|t-test, 2 sided|||||0.19|0.00|0.065
71058547|NCT03573830|141622961|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.03|TWO_SIDED|95.0|0.01|0.28||Threshold for significance: \<0.05|t-test, 2 sided|||||0.28|0.01|0.030
71058548|NCT02969382|141622986|SUPERIORITY||Mean Difference (Net)|-7.5|STANDARD_ERROR_OF_MEAN|2.23||0.001|TWO_SIDED|95.0|-11.9|-3.0|||Mixed Models Analysis|||||-3.0|-11.9|0.001
71058549|NCT02969382|141622987|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.7|-0.2|||Mixed Models Analysis|||||-0.2|-0.7|<0.001
71058550|NCT02969382|141622988|SUPERIORITY||Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|0.71||0.019|TWO_SIDED|95.0|-3.1|-0.3|||Mixed Models Analysis|||||-0.3|-3.1|0.019
71058551|NCT02969382|141622989|SUPERIORITY||Mean Difference (Net)|-1.5|STANDARD_ERROR_OF_MEAN|0.55||0.008|TWO_SIDED|95.0|-2.6|-0.4|||Mixed Models Analysis|||||-0.4|-2.6|0.008
71058552|NCT02969382|141622990|SUPERIORITY||Mean Difference (Net)|-4.3|STANDARD_ERROR_OF_MEAN|1.15|<|0.001|TWO_SIDED|95.0|-6.6|-2.0|||Mixed Models Analysis|||||-2.0|-6.6|<0.001
71058553|NCT02969382|141622991|SUPERIORITY||Mean Difference (Net)|-4.3|STANDARD_ERROR_OF_MEAN|1.26|<|0.001|TWO_SIDED|95.0|-6.8|-1.8|||Mixed Models Analysis|||||-1.8|-6.8|<0.001
71058554|NCT02969382|141622992|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.75||0.02|TWO_SIDED|95.0|-3.2|-0.3|||Mixed Models Analysis|||||-0.3|-3.2|0.020
71058555|NCT02969382|141622993|SUPERIORITY||Odds Ratio (OR)|2.645||||0.002|TWO_SIDED|95.0|1.422|4.921|||Regression, Logistic|||||4.921|1.422|0.002
71058556|NCT02969382|141622995|OTHER|||||||0.498|||||||Fisher Exact|||||||0.498
71058557|NCT02969382|141622996|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
70935300|NCT03960645|141371326|OTHER||GLSM ratio (%)|64.71|||||TWO_SIDED|90.0|59.3|70.61||||||FTC: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||70.61|59.30|
71058558|NCT02969382|141622997|OTHER|||||||0.498|||||||Fisher Exact|||||||0.498
71058559|NCT00886015|141623015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36|||||TWO_SIDED|95.0|0.96|1.93||||||||1.93|0.96|
71058560|NCT00886015|141623016|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.46|0.98||||||||0.98|0.46|
71058561|NCT00886015|141623017|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.66|1.18||||||||1.18|0.66|
71058562|NCT00886015|141623018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.44|0.98||||||||0.98|0.44|
71058563|NCT00886015|141623019|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64|||||TWO_SIDED|95.0|0.42|0.97||||||Mild ECA compared with Normal||0.97|0.42|
71058564|NCT00886015|141623019|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63|||||TWO_SIDED|95.0|0.39|1.01||||||Moderate ECA compared with Normal||1.01|0.39|
71058565|NCT00886015|141623019|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62|||||TWO_SIDED|95.0|0.35|1.1||||||Severe ECA compared with Normal||1.10|0.35|
71058566|NCT00886015|141623020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.97|1.53||||||||1.53|0.97|
71058567|NCT01983566|141623031|NON_INFERIORITY_OR_EQUIVALENCE|The actual number of subjects analyzed is 16. No formal statistical hypothesis was tested.|Geometric mean ratio (%)|115.8||||0.3944|TWO_SIDED|90.0|63.52|211.11||The p-value relates to the null hypothesis of non-equivalence (bioequivalence test). P-value for ratio outside interval 80-125%.|ANOVA||This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'. The statistical analysis result is based on the adjusted means.|"The difference between the expected means for log(Dele low fat) and log(Dele fasted) was estimated by the differences in the adjusted means (Least Squares Means), and a 2 sided 90% confidence interval (CI) based on the t-distribution was computed.~These were then back transformed. The estimation model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'."||211.11|63.52|0.3944
71058568|NCT01983566|141623032|NON_INFERIORITY_OR_EQUIVALENCE|The actual number of subjects analyzed is 16. No formal statistical hypothesis was tested.|Geometric mean ratio (%)|114.83||||0.3674|TWO_SIDED|90.0|74.803|176.281||The p-value relates to the null hypothesis of non-equivalence (bioequivalence test). P-value for ratio outside interval 80-125%.|ANOVA||This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'. The statistical analysis result is based on the adjusted means.|"The difference between the expected means for log(Dele low fat) and log(Dele fasted) was estimated by the differences in the adjusted means (Least Squares Means), and a 2 sided 90% CI based on the t-distribution was computed.~These were then back transformed. This estimation model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'."||176.281|74.803|0.3674
71058569|NCT01473407|141623058|NON_INFERIORITY_OR_EQUIVALENCE|An equivalence margin of +/- 0.5 was considered relevant to demonstrate the equivalence of the two products.|LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.066|||TWO_SIDED|95.0|-0.25|0.01||||||Least Square (LS) mean and 95 percent confidence interval (CI) were derived from an ANCOVA model with fixed effect of treatment.||0.01|-0.25|
71058570|NCT01473407|141623059|NON_INFERIORITY_OR_EQUIVALENCE|An equivalence margin of +/- 0.5 was considered relevant to demonstrate the equivalence of the two products.|LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|5.483|||TWO_SIDED|95.0|-10.4|11.13||||||LS mean and 95 percent CI were derived from an ANCOVA model with fixed effect of treatment.||11.13|-10.40|
71058571|NCT01473407|141623060|SUPERIORITY_OR_OTHER|||||||0.7563||||||P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.|Wilcoxon Rank Sum test|||||||0.7563
71058572|NCT01473407|141623061|SUPERIORITY_OR_OTHER|||||||0.1061||||||P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.|Wilcoxon Rank Sum test|||||||0.1061
71058573|NCT01473407|141623062|SUPERIORITY_OR_OTHER|||||||0.3369||||||P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.|Wilcoxon Rank Sum test|||||||0.3369
71058574|NCT02422797|141623109|NON_INFERIORITY|Non-inferiority was concluded if the lower bound of a two-sided 95% confidence interval for the difference in response rates between the two treatment arms was greater than -10%.|Risk Difference (RD)|0.2|||||TWO_SIDED|95.0|-3.9|4.2|||||Estimates based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factors: Age group (\< or \>=50 years old) and Baseline third agent (PI, NNRTI, INSTI).|||4.2|-3.9|
70935301|NCT03960645|141371326|OTHER||GLSM ratio (%)|46.92|||||TWO_SIDED|90.0|39.57|55.64||||||FTC: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||55.64|39.57|
70935302|NCT00403494|141371341|SUPERIORITY|PWT was transformed to the log ratio at Week 24:Baseline for statistical analysis.|Mean Difference (Final Values)|-0.021|STANDARD_DEVIATION|0.379||0.727|TWO_SIDED|95.0|-0.138|0.097|||t-test, 2 sided||Mean difference represents the difference of the means of the natural log-transformed ratios between the 2 treatment groups.|||0.097|-0.138|0.727
71025955|NCT02637557|141559145|SUPERIORITY||LS Mean Difference|-0.355||||0.0193|TWO_SIDED|95.0|-0.652|-0.058||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||-0.058|-0.652|0.0193
71025956|NCT02637557|141559145|SUPERIORITY||LS Mean Difference|-0.037||||0.8046|TWO_SIDED|95.0|-0.333|0.258||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.258|-0.333|0.8046
71058575|NCT02422797|141623111|OTHER||Risk Difference (RD)|-1.1|||||TWO_SIDED|95.0|-4.0|1.8|||||Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factors: Age group (\< or \>=50 years old) and Baseline third agent (PI, NNRTI, INSTI). No formal non-inferiority margin has been pre-specified for secondary endpoints.|||1.8|-4.0|
71058576|NCT02422797|141623122|OTHER|||||||0.007||||||P-value for interaction between treatment group and Baseline third agent (25 hydroxy-vitamin D)|ANCOVA|||||||0.007
71058577|NCT02422797|141623122|SUPERIORITY||Odds Ratio (OR)|0.861||||0.011|TWO_SIDED|95.0|0.767|0.967||P value assessed the difference between treatment groups (25 hydroxy-vitamin D - INSTI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.967|0.767|0.011
71058578|NCT02422797|141623122|SUPERIORITY||Odds Ratio (OR)|1.012||||0.745|TWO_SIDED|95.0|0.943|1.085||P value assessed the difference between treatment groups (25 hydroxy-vitamin D - NNRTI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||1.085|0.943|0.745
71058579|NCT02422797|141623122|SUPERIORITY||Odds Ratio (OR)|0.877||||0.018|TWO_SIDED|95.0|0.787|0.977||P value assessed the difference between treatment groups (25 hydroxy-vitamin D - PI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.977|0.787|0.018
71058580|NCT02422797|141623124|OTHER|||||||0.001||||||P-value for interaction between treatment group and Baseline third agent (bone-specific alkaline phosphatase)|ANCOVA|||||||0.001
71058581|NCT02422797|141623124|SUPERIORITY||Odds Ratio (OR)|0.728|||<|0.001|TWO_SIDED|95.0|0.686|0.773||P value assessed the difference between treatment groups (bone-specific alkaline phosphatase - NNRTI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.773|0.686|<.001
71058582|NCT02422797|141623124|SUPERIORITY||Odds Ratio (OR)|0.865||||0.004|TWO_SIDED|95.0|0.785|0.954||P value assessed the difference between treatment groups (bone-specific alkaline phosphatase - INSTI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.954|0.785|0.004
71058583|NCT02422797|141623124|SUPERIORITY||Odds Ratio (OR)|0.788|||<|0.001|TWO_SIDED|95.0|0.719|0.864||P value assessed the difference between treatment groups (bone-specific alkaline phosphatase - PI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.864|0.719|<.001
71058584|NCT02422797|141623124|OTHER|||||||0.677||||||P-value for interaction between treatment group and Baseline third agent (procollagen type 1-N-propeptide)|ANCOVA|||||||0.677
71058585|NCT02422797|141623124|SUPERIORITY||Odds Ratio (OR)|0.867|||<|0.001|TWO_SIDED|95.0|0.823|0.914||P value assessed the difference between treatment groups (procollagen type 1-N-propeptide)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.914|0.823|<.001
71058586|NCT02422797|141623124|OTHER||||||<|0.001||||||P-value for interaction between treatment group and Baseline third agent (osteocalcin)|ANCOVA|||||||<.001
71058587|NCT02422797|141623124|SUPERIORITY||Odds Ratio (OR)|0.853|||<|0.001|TWO_SIDED|95.0|0.799|0.91||P value assessed the difference between treatment groups (osteocalcin - NNRTI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.910|0.799|<.001
71058588|NCT02422797|141623124|SUPERIORITY||Odds Ratio (OR)|0.886||||0.028|TWO_SIDED|95.0|0.796|0.987||P value assessed the difference between treatment groups (osteocalcin - INSTI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.987|0.796|0.028
71058589|NCT02422797|141623124|SUPERIORITY||Odds Ratio (OR)|0.743|||<|0.001|TWO_SIDED|95.0|0.672|0.822||P value assessed the difference between treatment groups (osteocalcin - PI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.822|0.672|<.001
70935303|NCT01335061|141371345|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Paired t-test|||||||<0.0001
71058590|NCT02422797|141623124|OTHER|||||||0.782||||||P-value for interaction between treatment group and Baseline third agent (type 1 collagen cross-linked C-telopeptide)|ANCOVA|||||||0.782
71058591|NCT02422797|141623124|SUPERIORITY||Odds Ratio (OR)|0.818|||<|0.001|TWO_SIDED|95.0|0.751|0.891||P value assessed the difference between treatment groups (type 1 collagen cross-linked C-telopeptide)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.891|0.751|<.001
71058592|NCT02422797|141623137|OTHER|||||||0.179||||||One-sided p-value from weighted least squares chi-squared statistic. A p-value \<=0.10 was used to indicate statistically significant evidence of heterogeneity in the difference in proportions across levels of each analysis strata.|Chi-squared, Corrected|||||||0.179
70935304|NCT01536704|141371356|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for AUC (0-t) lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.91|||||TWO_SIDED|90.0|0.88|0.94|||Wilcoxon Signed Rank Test||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||0.94|0.88|
70935305|NCT01536704|141371356|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for AUC (0-t) lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.98|1.05|||Wilcoxon Signed Rank test||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||1.05|0.98|
70935306|NCT01536704|141371357|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for Cmax lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.89|||||TWO_SIDED|90.0|0.85|0.94|||Wilcoxon Signed Rank Test||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||0.94|0.85|
70935307|NCT01536704|141371357|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for Cmax lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.97|||||TWO_SIDED|90.0|0.93|1.02|||Wilcoxon Signed Rank Test||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||1.02|0.93|
70935308|NCT01536704|141371358|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for AUC (0-inf) lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.92||||||90.0|0.88|0.95|||Wilcoxon Signed Rank Test||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||0.95|0.88|
70852077|NCT02043808|141192616|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.6|||||TWO_SIDED|95.0|0.52|0.69|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.69|0.52|
70941712|NCT04748445|141383935|OTHER||Slope|4.12|STANDARD_ERROR_OF_MEAN|1.464||0.0057|TWO_SIDED|90.0|1.694|6.546|||Mixed Models Analysis|||EE\_MFCC 1st order delta 02 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-3.||6.546|1.694|0.0057
71025957|NCT02637557|141559145|SUPERIORITY||LS Mean Difference|-0.319||||0.035|TWO_SIDED|95.0|-0.616|-0.023||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.023|-0.616|0.0350
71025958|NCT02637557|141559145|SUPERIORITY||LS Mean Difference|-0.392||||0.0105|TWO_SIDED|95.0|-0.691|-0.093||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.093|-0.691|0.0105
71025959|NCT02637557|141559145|SUPERIORITY||LS Mean Difference|-0.094||||0.5482|TWO_SIDED|95.0|-0.403|0.214||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.214|-0.403|0.5482
71025960|NCT02637557|141559145|SUPERIORITY||LS Mean Difference|-0.377||||0.017|TWO_SIDED|95.0|-0.687|-0.068||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.068|-0.687|0.0170
71025961|NCT02637557|141559145|SUPERIORITY||LS Mean Difference|-0.469||||0.0034|TWO_SIDED|95.0|-0.781|-0.157||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.157|-0.781|0.0034
71025962|NCT02637557|141559145|SUPERIORITY||LS Mean Difference|-0.093||||0.5346|TWO_SIDED|95.0|-0.388|0.202||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.202|-0.388|0.5346
71058593|NCT02422797|141623137|OTHER||Risk Difference (RD)|3.5|||||TWO_SIDED|95.0|-1.6|8.6|||||NNRTI: No formal non-inferiority margin has been pre-specified for secondary endpoints.|||8.6|-1.6|
71058594|NCT02422797|141623137|OTHER||Risk Difference (RD)|-2.4|||||TWO_SIDED|95.0|-12.1|7.4|||||INSTI: No formal non-inferiority margin has been pre-specified for secondary endpoints.|||7.4|-12.1|
71058595|NCT02422797|141623137|OTHER||Risk Difference (RD)|-5.4|||||TWO_SIDED|95.0|-13.9|3.1|||||PI: No formal non-inferiority margin has been pre-specified for secondary endpoints.|||3.1|-13.9|
71058596|NCT02422797|141623145|OTHER|||||||0.43||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 4)|ANCOVA|||||||0.430
71058597|NCT02422797|141623145|OTHER||Mean Difference (Final Values)|-1.239||||0.039|TWO_SIDED|95.0|-2.414|-0.064||P value assessed the difference between treatment groups (Symptom Bother Score - Week 4)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.|||-0.064|-2.414|0.039
71058598|NCT02422797|141623145|OTHER|||||||0.542||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 24)|ANCOVA|||||||0.542
71058599|NCT02422797|141623145|SUPERIORITY||Mean Difference (Final Values)|-0.528||||0.448|TWO_SIDED|95.0|-1.896|0.84||P value assessed the difference between treatment groups (Symptom Bother Score - Week 24)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.|||0.840|-1.896|0.448
71058600|NCT02422797|141623145|OTHER|||||||0.402||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 48)|ANCOVA|||||||0.402
70935309|NCT01536704|141371358|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for AUC (0-inf) lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.98|1.06|||Wilcoxon Signed Rank Test||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||1.06|0.98|
70935310|NCT01536704|141371359|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0006||||0.1491||95.0|||||Wilcoxon Signed Rank Test|The value of Tmax was adjusted for this non-parametric analysis.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.1491
70935311|NCT01536704|141371359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0005||||0.679||95.0|||||Wilcoxon Signed Rank Test|The value of Tmax was adjusted for this non-parametric analysis.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.6790
70935312|NCT01536704|141371360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0641||||0.5619||95.0|||||Wilcoxon Signed Rank Test|The value of T (1/2) was adjusted for this non-parametric analysis.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.5619
70935313|NCT01536704|141371360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0538||||0.4523||95.0|||||Wilcoxon Signed Rank Test|The value of T (1/2) was adjusted for this non-parametric analysis.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.4523
70935314|NCT01536704|141371361|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0025||||0.5113||95.0|||||Wilcoxon Signed Rank Test|This non-parametric analysis was performed on the unadjusted values of parameters.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.5113
71058601|NCT02422797|141623145|SUPERIORITY||Mean Difference (Final Values)|-1.037||||0.164|TWO_SIDED|95.0|-2.501|0.426||P value assessed the difference between treatment groups (Symptom Bother Score - Week 48)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.|||0.426|-2.501|0.164
71058602|NCT02422797|141623148|SUPERIORITY|||||||0.037||||||P-value assessed the HIVTSQs Total Score difference between treatment groups (Week 4)|Wilcoxon rank sum test|||||||0.037
71058603|NCT02422797|141623148|SUPERIORITY|||||||0.101||||||P-value assessed the HIVTSQs Total Score difference between treatment groups (Week 24)|Wilcoxon rank sum test|||||||0.101
71058604|NCT02422797|141623148|SUPERIORITY|||||||0.042||||||P-value assessed the HIVTSQs Total score difference between treatment groups (Week 48)|Wilcoxon rank sum test|||||||0.042
71109026|NCT03188263|141723657|OTHER|The primary planned analysis was in bright light group only and compared pre-post measurements.||||||0.35||||||A threshold of .05 was selected a priori.|Sign test|A Wilcoxon matched-pairs signed-ranks test was estimated to determine if pre-post measures of glucose levels differed significantly.||The primary planned analyses was to examine effect in bright light group. A significance level of .05 was selected a priori.||||.35
70935315|NCT01536704|141371361|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.0042||||0.537||95.0|||||Wilcoxon Signed Rank Test|This non-parametric analysis was performed on the unadjusted values of parameters.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.5370
70935316|NCT00047385|141371362|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.004|TWO_SIDED|95.0|0.733|0.932||P-value is adjusted for multiple comparisons.|Weighted log-rank (details below)|Weights in weighted log-rank statistic increased linearly from zero at randomization to full weight at 4 years and thereafter.||"Alternative hypothesis: LDCT screening reduces lung cancer mortality relative to chest x-ray.~Power: 90% for a 20% reduction in lung cancer mortality."||0.932|0.733|0.004
70935317|NCT00047385|141371363|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.933||||0.02|TWO_SIDED|95.0|0.864|0.988||No adjustment for multiple comparisons. Only one analysis performed.|Weighted log-rank (details below)|Weights in weighted log-rank statistic increased linearly from zero at randomization to full weight at 4 years and thereafter.||Alternative hypothesis: LDCT screening reduced all-cause mortality relative to chest x-ray.||0.988|0.864|0.02
70935318|NCT00047385|141371364|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|1.03|1.23|||||Denominator: LDCT Group Numerator: CXR Group|||1.23|1.03|
70935319|NCT03316170|141371553|SUPERIORITY||Mean Difference (Final Values)|-0.86|STANDARD_ERROR_OF_MEAN|0.44||0.06|TWO_SIDED|95.0|-1.75|0.3|||t-test, 2 sided|||||0.30|-1.75|.06
70935320|NCT03052517|141371554|OTHER||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.74|1.0|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 150mg / Placebo||1.00|0.74|
71058605|NCT02422797|141623148|SUPERIORITY|||||||0.132||||||P-value assessed the HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 4)|Wilcoxon rank sum test|||||||0.132
71058606|NCT02422797|141623148|SUPERIORITY|||||||0.022||||||P-value assessed the HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 24)|Wilcoxon rank sum test|||||||0.022
71058607|NCT02422797|141623148|SUPERIORITY|||||||0.004||||||P-value assessed the HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 48)|Wilcoxon rank sum test|||||||0.004
71058608|NCT02422797|141623148|SUPERIORITY|||||||0.076||||||P-value assessed the HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 4)|Wilcoxon rank sum test|||||||0.076
71058609|NCT02422797|141623148|SUPERIORITY|||||||0.073||||||P-value assessed the HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 24)|Wilcoxon rank sum test|||||||0.073
71109027|NCT00539240|141723677|SUPERIORITY_OR_OTHER|||||||0.04||||||P\<0.05 considered statistically significant. No adjustment for multiple comparisons|Regression, Linear|adjusted for age, sex, BMI and ethnicity||||||0.04
71109028|NCT00539240|141723677|SUPERIORITY_OR_OTHER|||||||0.5||||||P\<0.05 considered statistically significant, No adjustment for multiple comparisons|Regression, Linear|adjusted for age, sex, BMI and ethnicity||||||0.50
70852078|NCT03703297|141192644|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.01608|TWO_SIDED|95.0|0.606|0.95|||Log Rank|The analysis was performed using the stratified log-rank test.|Hazard ratio and CI calculated using stratified Cox proportional hazards model,adjusting for tumor,node and metastasis(TNM) stage, receipt of prophylactic cranial irradiation(PCI),with treatment as only covariate and ties handled by Efron approach.|||0.950|0.606|0.01608
71025963|NCT02637557|141559145|SUPERIORITY||LS Mean Difference|-0.336||||0.0262|TWO_SIDED|95.0|-0.632|-0.04||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.040|-0.632|0.0262
71025964|NCT02637557|141559145|SUPERIORITY||LS Mean Difference|-0.545||||0.0004|TWO_SIDED|95.0|-0.843|-0.246||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.246|-0.843|0.0004
71025965|NCT02637557|141559146|SUPERIORITY||LS Mean Difference|0.098||||0.3007|TWO_SIDED|95.0|-0.088|0.284||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.284|-0.088|0.3007
71025966|NCT02637557|141559146|SUPERIORITY||LS Mean Difference|0.143||||0.1295|TWO_SIDED|95.0|-0.042|0.328||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.328|-0.042|0.1295
71025967|NCT02637557|141559146|SUPERIORITY||LS Mean Difference|-0.028||||0.7671|TWO_SIDED|95.0|-0.216|0.159||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.159|-0.216|0.7671
71025968|NCT02637557|141559146|SUPERIORITY||LS Mean Difference|0.01||||0.9308|TWO_SIDED|95.0|-0.217|0.238||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.238|-0.217|0.9308
71025969|NCT02637557|141559146|SUPERIORITY||LS Mean Difference|0.051||||0.6595|TWO_SIDED|95.0|-0.176|0.277||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.277|-0.176|0.6595
71025970|NCT02637557|141559146|SUPERIORITY||LS Mean Difference|-0.127||||0.2771|TWO_SIDED|95.0|-0.356|0.102||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.102|-0.356|0.2771
71025971|NCT02637557|141559146|SUPERIORITY||LS Mean Difference|-0.203||||0.0887|TWO_SIDED|95.0|-0.436|0.031||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.031|-0.436|0.0887
71025972|NCT02637557|141559146|SUPERIORITY||LS Mean Difference|-0.21||||0.0758|TWO_SIDED|95.0|-0.443|0.022||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.022|-0.443|0.0758
71025973|NCT02637557|141559146|SUPERIORITY||LS Mean Difference|-0.298||||0.0132|TWO_SIDED|95.0|-0.534|-0.063||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.063|-0.534|0.0132
71025974|NCT02637557|141559146|SUPERIORITY||LS Mean Difference|-0.086||||0.4903|TWO_SIDED|95.0|-0.332|0.16||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.160|-0.332|0.4903
71058610|NCT02422797|141623148|SUPERIORITY|||||||0.547||||||P-value assessed the HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 48)|Wilcoxon rank sum test|||||||0.547
71077952|NCT02913105|141664400|OTHER|Change from baseline was analyzed using an ANCOVA model which included effects for treatment, baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|7.01|STANDARD_ERROR_OF_MEAN|5.52||0.2073|TWO_SIDED|90.0|-2.161|16.178|||ANCOVA|||||16.178|-2.161|0.2073
70852079|NCT03703297|141192645|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.01042|TWO_SIDED|95.0|0.569|0.928|||Log Rank|The analysis was performed using the stratified log-rank test.|Hazard ratio and CI were calculated using stratified Cox proportional hazards model, adjusting for receipt of PCI, with treatment as only covariate and ties handled by Efron approach.|||0.928|0.569|0.01042
71025975|NCT02637557|141559146|SUPERIORITY||LS Mean Difference|-0.068||||0.5824|TWO_SIDED|95.0|-0.313|0.176||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.176|-0.313|0.5824
71025976|NCT02637557|141559146|SUPERIORITY||LS Mean Difference|-0.215||||0.0885|TWO_SIDED|95.0|-0.463|0.033||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.033|-0.463|0.0885
71025977|NCT02637557|141559146|SUPERIORITY||LS Mean Difference|-0.111||||0.3652|TWO_SIDED|95.0|-0.352|0.13||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.130|-0.352|0.3652
71025978|NCT02637557|141559146|SUPERIORITY||LS Mean Difference|-0.108||||0.3739|TWO_SIDED|95.0|-0.348|0.131||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.131|-0.348|0.3739
71025979|NCT02637557|141559146|SUPERIORITY||LS Mean Difference|-0.27||||0.0294|TWO_SIDED|95.0|-0.512|-0.027||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||-0.027|-0.512|0.0294
71077953|NCT02913105|141664400|SUPERIORITY|Change from baseline was analyzed using an ANCOVA model which included effects for treatment, baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|7.23|STANDARD_ERROR_OF_MEAN|5.62||0.2014|TWO_SIDED|90.0|-2.106|16.563|||ANCOVA|||||16.563|-2.106|0.2014
71058611|NCT01027702|141623236|OTHER|||||||||||||||||"This was a dose-escalation study to determine a target DLI dose at which the:~1. Probability of CD4+ cells \> 100/µL by Day +120 is at least 66% and~2. Probability of grade II and III GVHD is at most 33%, probability of grade III GVHD is at most 17%, and no grade IV GVHD occurs Patients were assigned in cohorts of 3."|"The study design consisted of two phases, a dose-escalation phase and a dose-confirmation phase. In the dose-escalation phase, patients were assigned in cohorts of 3. The dose escalation plan was:~* If a grade IV acute GVHD event was observed at any dose, no more patients were assigned to this or higher dose levels unless the methotrexate dosing was modified.~* If none of the initial three patients at a dose level experienced grade II/III GVHD and \< 2/3 had a CD4+ count \> 100 at Day +120, the next three patients were assigned to the next higher dose level.~* If 1 out of 3 patients had grade III GVHD or 1 - 2 out of 3 patients had grade II GVHD and/or \> 2/3 have a CD4+ count \> 100 at Day +120, the dose was repeated for the next 3 patients.~The dose of 5 x 10\^4 CD3+ cells/kg was determined to be the optimal dose."|||
71058612|NCT01027702|141623237|OTHER|||||||||||||||||"This was a dose-escalation study to determine a target DLI dose at which the:~1. Probability of CD4+ cells \> 100/µL by Day +120 is at least 66% and~2. Probability of grade II and III GVHD is at most 33%, probability of grade III GVHD is at most 17%, and no grade IV GVHD occurs Patients were assigned in cohorts of 3."|"The study design consisted of two phases, a dose-escalation phase and a dose-confirmation phase. In the dose-escalation phase, patients were assigned in cohorts of 3. The dose escalation plan was:~If a grade IV acute GVHD event was observed at any dose, no more patients were assigned to this or higher dose levels unless the methotrexate dosing was modified.~If none of the initial three patients at a dose level experienced grade II/III GVHD and \< 2/3 had a CD4+ count \> 100 at Day +120, the next three patients were assigned to the next higher dose level.~If 1 out of 3 patients had grade III GVHD or 1 - 2 out of 3 patients had grade II GVHD and/or \> 2/3 have a CD4+ count \> 100 at Day +120, the dose was repeated for the next 3 patients.~The dose of 5 x 10\^4 CD3+ cells/kg was determined to be the optimal dose."|||
71058613|NCT00403585|141623239|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 156.|Wilcoxon signed rank|||||||<0.001
71058614|NCT02964312|141623256|SUPERIORITY||Proportion|89.5|||||TWO_SIDED|95.0|83.5|93.9||||||The null hypothesis was that the proportion of responders at 6 months would be 50%. Since there was not direct comparison group, the hypothesis was set as a superiority comparison to a target proportion (66%) with a power level \>90%.||93.9|83.5|
71058615|NCT02964312|141623259|SUPERIORITY||||||<|0.001||||||P values are based on paired t-tests for change from baseline with p\<0.05 indicating significance.|t-test, 2 sided|||||||<0.001
71058616|NCT02276807|141623262|SUPERIORITY||Mean Difference (Final Values)|0.345|||<|0.05|TWO_SIDED||||||ANOVA|2 (Condition: TAU, BA-PC) X 2 (Time: Baseline vs. Week 12) repeated measures ANOVA||||||<0.05
71058617|NCT02276807|141623263|SUPERIORITY||Mean Difference (Final Values)|0.046|||<|0.05|TWO_SIDED||||||ANOVA|2 (Condition: TAU vs. BA-PC) X 2 (time: Baseline vs. week 12) repeated measures ANOVA||||||<0.05
71058618|NCT02276807|141623264|SUPERIORITY||Mean Difference (Final Values)|0.666|||<|0.05|TWO_SIDED||||||ANOVA|2 (Condition: TAU, BA-PC) X 2 (Time: Baseline, Week 12) Repeated Measures ANOVA||||||<0.05
71109029|NCT00539240|141723678|SUPERIORITY_OR_OTHER|||||||0.19||||||P\<0.05 considered statistically significant. No adjustment for multiple comparisons (no post-hoc contrasts performed)|ANCOVA|Adjusted for baseline score and personality traits (SCL-90)||||||0.19
71058619|NCT02276807|141623265|SUPERIORITY||Mean Difference (Final Values)|0.014|||<|0.05|TWO_SIDED||||||ANOVA|2 (Condition: TAU vs. BA-PC) X 2 (Time: Baseline, Week 12) Repeated Measures ANOVA||||||<0.05
71058620|NCT02276807|141623266|SUPERIORITY||Mean Difference (Final Values)|0.722|||<|0.05|TWO_SIDED||||||ANOVA|2 (Condition: TAU vs. BA-PC) X 2 (Time: Baseline vs. Week 12) Repeated Measures ANOVA||||||<0.05
70935321|NCT03052517|141371554|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.72|0.97|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / Placebo||0.97|0.72|
71109030|NCT00539240|141723679|SUPERIORITY_OR_OTHER|||||||0.04||||||P\<0.05 considered statistically significant, No adjustment for multiple comparisons|Regression, Linear|adjusted for age, sex, BMI and ethnicity.||||||0.04
70935322|NCT03052517|141371554|OTHER||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.87|1.09|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / QAW039 150mg||1.09|0.87|
71058621|NCT01023035|141623268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-8.6|7.2|||Mantel-Haenszel, modified Koch method|||The modified Koch method was used to calculate the stratum-adjusted Mantel-Haenszel (MH) difference between the SVR rates for the Erythropoietin Use Arm versus the Ribavirin Dose Reduction Arm and corresponding 95% confidence interval with continuity correction.||7.2|-8.6|
71058622|NCT03127514|141623282|SUPERIORITY|||||||0.03||||||A two-tailed P value of 0.05 or less was considered to indicate statistical significance.|Mixed Models Analysis|Random-slope, shared-baseline, linear mixed model was adjusted for age and prebaseline ALSFRS-R slope||||||0.03
71058623|NCT02413229|141623306|SUPERIORITY|||||||0.3571|||||||Cochran-Mantel-Haenszel|||||||0.3571
71058624|NCT02413229|141623306|SUPERIORITY|||||||0.5224|||||||Cochran-Mantel-Haenszel|||||||0.5224
71058625|NCT02413229|141623306|SUPERIORITY|||||||0.389|||||||Cochran-Mantel-Haenszel|||||||0.3890
71058626|NCT02413229|141623306|SUPERIORITY|||||||0.0325|||||||Cochran-Mantel-Haenszel|||||||.0325
71058627|NCT02932462|141623307|SUPERIORITY|||||||0.4557|||||||Cochran-Mantel-Haenszel|||||||0.4557
71058628|NCT02932462|141623308|SUPERIORITY|||||||0.8096|||||||Cochran-Mantel-Haenszel|||||||0.8096
71058629|NCT02932462|141623309|SUPERIORITY|||||||0.7652|||||||Cochran-Mantel-Haenszel|||||||0.7652
71109031|NCT00539240|141723679|SUPERIORITY_OR_OTHER|||||||0.5||||||P\<0.05 considered statistically significant, no adjustment for multiple comparisons|Regression, Linear|adjusted for age, sex, BMI and ethnicity||||||0.50
71109032|NCT00539240|141723680|SUPERIORITY_OR_OTHER|||||||0.04||||||P\<0.05 considered statistically significant. No adjustment for multiple comparisons.|Regression, Linear|adjusted for age, sex, BMI and ethnicity||||||0.04
71109033|NCT00539240|141723680|SUPERIORITY_OR_OTHER|||||||0.2||||||P\<0.05 considered statistically significant. No adjustment for multiple comparisons.|Regression, Linear|adjusted for age, sex, BMI and ethnicity.||||||0.20
71109034|NCT01628523|141723682|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.08|||<|0.05|TWO_SIDED||||||Regression, Logistic|||||||<0.05
71025980|NCT02637557|141559146|SUPERIORITY||LS Mean Difference|-0.102||||0.4236|TWO_SIDED|95.0|-0.351|0.148||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.148|-0.351|0.4236
71025981|NCT02637557|141559146|SUPERIORITY||LS Mean Difference|-0.105||||0.4071|TWO_SIDED|95.0|-0.353|0.144||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.144|-0.353|0.4071
71109035|NCT02765399|141723685|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71109036|NCT02765399|141723685|OTHER|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
71025982|NCT02637557|141559146|SUPERIORITY||LS Mean Difference|-0.259||||0.0434|TWO_SIDED|95.0|-0.51|-0.008||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.008|-0.510|0.0434
71109037|NCT02765399|141723686|OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
71025983|NCT02637557|141559146|SUPERIORITY||LS Mean Difference|-0.103||||0.4172|TWO_SIDED|95.0|-0.354|0.147||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.147|-0.354|0.4172
71025984|NCT02637557|141559146|SUPERIORITY||LS Mean Difference|-0.071||||0.5759|TWO_SIDED|95.0|-0.321|0.179||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.179|-0.321|0.5759
71025985|NCT02637557|141559146|SUPERIORITY||LS Mean Difference|-0.285||||0.0271|TWO_SIDED|95.0|-0.538|-0.033||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.033|-0.538|0.0271
71025986|NCT02637557|141559146|SUPERIORITY||LS Mean Difference|-0.14||||0.2804|TWO_SIDED|95.0|-0.395|0.115||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.115|-0.395|0.2804
71058630|NCT02652949|141623310|SUPERIORITY||Event rate|0.023|||<|0.0001|ONE_SIDED|97.5||0.081|||Exact binomial test|||"The primary study endpoint, major device effect at 30 days, is a dichotomous study outcome; hence, an exact method based on the binomial distribution was used for the hypothesis testing. The primary study endpoint was tested against a performance goal of 16%:~H0: p ≥ 16% vs. Ha: p \<16%, where p denotes the true event rate of primary study endpoint in the target population."||0.081||<0.0001
71058631|NCT01330303|141623326|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|101.89||||||90.0|94.91|109.39|||||The ratios between the geometric means of the test (T) and reference (R) formulations were calculated.|||109.39|94.91|
71025987|NCT02637557|141559146|SUPERIORITY||LS Mean Difference|-0.218||||0.0913|TWO_SIDED|95.0|-0.472|0.035||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.035|-0.472|0.0913
71025988|NCT02637557|141559146|SUPERIORITY||LS Mean Difference|-0.38||||0.0039|TWO_SIDED|95.0|-0.637|-0.123||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.123|-0.637|0.0039
71025989|NCT02637557|141559147|SUPERIORITY||LS Mean Difference|0.128||||0.1902|TWO_SIDED|95.0|-0.064|0.319||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.319|-0.064|0.1902
71025990|NCT02637557|141559147|SUPERIORITY||LS Mean Difference|0.1||||0.3021|TWO_SIDED|95.0|-0.091|0.292||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.292|-0.091|0.3021
71025991|NCT02637557|141559147|SUPERIORITY||LS Mean Difference|-0.028||||0.775|TWO_SIDED|95.0|-0.221|0.165||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.165|-0.221|0.7750
71025992|NCT02637557|141559147|SUPERIORITY||LS Mean Difference|0.099||||0.4022|TWO_SIDED|95.0|-0.133|0.33||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.330|-0.133|0.4022
71025993|NCT02637557|141559147|SUPERIORITY||LS Mean Difference|0.062||||0.5971|TWO_SIDED|95.0|-0.169|0.293||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.293|-0.169|0.5971
71109038|NCT02765399|141723686|OTHER|||||||0.612|||||||Wilcoxon (Mann-Whitney)|||||||0.612
71109039|NCT02765399|141723687|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71109040|NCT02765399|141723687|OTHER|||||||0.128|||||||Wilcoxon (Mann-Whitney)|||||||0.128
71109041|NCT02765399|141723688|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
71109042|NCT02765399|141723688|OTHER|||||||0.343|||||||Wilcoxon (Mann-Whitney)|||||||0.343
71109043|NCT02765399|141723689|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71109044|NCT02765399|141723689|OTHER|||||||0.865|||||||Wilcoxon (Mann-Whitney)|||||||0.865
71109045|NCT02765399|141723690|OTHER|||||||0.532|||||||Wilcoxon (Mann-Whitney)|||||||0.532
71109046|NCT02765399|141723690|OTHER|||||||0.735|||||||Wilcoxon (Mann-Whitney)|||||||0.735
71109047|NCT02765399|141723691|OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||||||0.017
70935323|NCT03052517|141371555|OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.76|1.02|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 150mg / Placebo||1.02|0.76|
70935324|NCT03052517|141371555|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.73|0.99|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / Placebo||0.99|0.73|
71058632|NCT01330303|141623327|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|101.91||||||90.0|95.0|109.33|||||The ratios between the geometric means of the test (T) and reference (R) formulations were calculated.|||109.33|95.00|
71058633|NCT01330303|141623328|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|94.04||||||90.0|86.33|102.44|||||The ratios between the geometric means of the test (T) and reference (R) formulations were calculated.|||102.44|86.33|
71058634|NCT00125515|141623370|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED|95.0|||||Chi-squared|||all statistical analysis were two tailed and employed an alpha significance level of 0.05.||||0.32
71058635|NCT03649347|141623375|SUPERIORITY||||||<|0.001||||||Interaction effect: p\<.001, np2=.720|ANOVA|Main effect of time: p\<.001, np2=.798; main effect of group: p\<.001, np2=.711||A repeated measures ANOVA was conducted to assess main effects of group (AR therapy intervention versus no treatment control), time (baseline, one week follow up, and one month follow up) as well as an interaction effect. The P-Value shown below is for the interaction effect. Post-hoc power analysis indicated actual power 99%, critical F=4.76.||||<.001
71058636|NCT03649347|141623376|SUPERIORITY||||||<|0.001||||||Interaction effect: p\<.001, np2=.542|ANOVA|Main effect of time: p\<.001, np2=.598; and main effect of group: p\<.001, np2=.439||A repeated measures ANOVA was conducted to assess main effects of group (AR therapy intervention versus no treatment control), time (baseline, one week follow up, and one month follow up) as well as an interaction effect. The P-Value shown below is for the interaction effect. Post-hoc power analysis indicated actual power 96%, critical F=4.76.||||<.001
71058637|NCT03649347|141623378|SUPERIORITY||||||<|0.005||||||Interaction effect: p\<.005, np2=.481|ANOVA|Main effect of time: p\<.001, np2=.572; and main effect of group p\<.001, np2=.626||A repeated measures ANOVA was conducted to assess main effects of group (AR therapy intervention versus no treatment control), time (baseline, one week follow up, and one month follow up) as well as an interaction effect. The P-Value shown below is for the interaction effect. Post-hoc power analysis indicated actual power 99%, critical F=3.49.||||<.005
71058638|NCT02517463|141623395|NON_INFERIORITY_OR_EQUIVALENCE|"The PPP from a previous study was 67.2%. Assuming the PPP in the preovulatory and post-ovulatory groups were equivalent, and taking 10% to be the maximum permitted difference for equivalence, a minimum of 273 subjects in each group would be required to confirm equivalence between the two groups with a power of 80% and type I error of 0.05. Therefore, our recruitment of 700 subjects with more than 300 in each group was sufficient."|||||<|0.0001|||||||Chi-squared|||||||<0.0001
71058639|NCT02517463|141623396|SUPERIORITY_OR_OTHER|||||||0.564|TWO_SIDED||||||Fisher Exact|||||||0.564
71058640|NCT02517463|141623397|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71058641|NCT02448368|141623398|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the Pharmacokinetics (PK), Pharmacodynamics (PD), and safety profile of RDEA3170.|Geometric Least Squares Mean Ratio|232.0|||||TWO_SIDED|90.0|202.0|266.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||266|202|
71058642|NCT02448368|141623398|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|181.0|||||TWO_SIDED|90.0|164.0|200.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||200|164|
70935325|NCT03052517|141371555|OTHER||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.86|1.08|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / QAW039 150mg||1.08|0.86|
70935326|NCT03052517|141371556|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.51|1.22|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 150mg / Placebo||1.22|0.51|
70935327|NCT03052517|141371556|OTHER||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.39|0.97|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / Placebo||0.97|0.39|
70935328|NCT03052517|141371556|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.54|1.14|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / QAW039 150mg||1.14|0.54|
71058643|NCT02448368|141623398|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|106.0|||||TWO_SIDED|90.0|91.5|124.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||124|91.5|
71109048|NCT02765399|141723691|OTHER|||||||0.753|||||||Wilcoxon (Mann-Whitney)|||||||0.753
71109049|NCT02765399|141723692|OTHER|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||||||0.047
71109050|NCT02765399|141723692|OTHER|||||||0.499|||||||Wilcoxon (Mann-Whitney)|||||||0.499
70935329|NCT03052517|141371557|OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.54|1.22|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 150mg / Placebo||1.22|0.54|
71109051|NCT02765399|141723693|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
71109052|NCT02765399|141723693|OTHER|||||||0.128|||||||Wilcoxon (Mann-Whitney)|||||||0.128
71109053|NCT02765399|141723694|OTHER|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||||||0.018
71109054|NCT02765399|141723694|OTHER|||||||0.578|||||||Wilcoxon (Mann-Whitney)|||||||0.578
71109055|NCT02765399|141723695|OTHER|||||||0.152|||||||Wilcoxon (Mann-Whitney)|||||||0.152
71109056|NCT02765399|141723695|OTHER|||||||0.866|||||||Wilcoxon (Mann-Whitney)|||||||0.866
71109057|NCT02765399|141723696|OTHER|||||||0.173|||||||Wilcoxon (Mann-Whitney)|||||||0.173
70852080|NCT01888432|141192669|NON_INFERIORITY|HO: πT - πC ≥ 0.12 vs. HA: πT - πC \< 0.12, where πT and πC are the true proportions of composite efficacy failure of tBPAR, GL, or D, (tBPAR/GL/D) at 12 months post-transplant for the respective treatment groups. The proportion of 0.12, or 12%, was pre-determined as the non-inferiority (NI) margin for composite efficacy failure.|Kaplan-Meier|-0.7|||<|0.001|TWO_SIDED|90.0|-5.2|3.7||Z-test p-value for non-inferiority test (non-inferiority margin = 12%) is for one-sided test and should be compared to 0.05 significance level.|Z-test|||non-inferior efficacy failure of the reduced tacrolimus regimen to control by rejecting the null hypothesis.||3.7|-5.2|< 0.001
70852081|NCT01888432|141192670|NON_INFERIORITY|the null hypothesis below was tested at the one-sided α = 0.05 level: H0: μT - μC ≤ -6 mL/min/1.73 m2 vs. HA: μT - μC \> -6 mL/min/1.73 m\^2, where μT and μC are the true means of change in eGFR (MDRD-4) from randomization to Month 12 post-transplant for the reduced tacrolimus group and control group, respectively.|Mean Difference (Net)|4.15|STANDARD_ERROR_OF_MEAN|2.574|<|0.001|TWO_SIDED|90.0|-0.09|8.4|||ANCOVA|||||8.40|-0.09|< 0.001
70852082|NCT01888432|141192671|OTHER||Mean Difference (Final Values)|3.25|STANDARD_ERROR_OF_MEAN|2.699|<|0.001|TWO_SIDED|90.0|-1.21|7.7|||ANCOVA|||||7.70|-1.21|<0.001
70852083|NCT01888432|141192673|OTHER|Month 12|Kaplan-Meier|-1.4|||||TWO_SIDED|90.0|-4.7|2.0|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||2.0|-4.7|
70852084|NCT01888432|141192673|OTHER|tBPAR - month 24|Kaplan-Meier|-1.2|||||TWO_SIDED|90.0|-5.1|2.6|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||2.6|-5.1|
70852085|NCT01888432|141192673|OTHER|On-treatment tBPAR - month 24|Kaplan-Meier|-2.1|||||TWO_SIDED|90.0|-5.7|1.4|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||1.4|-5.7|
70852086|NCT01888432|141192674|OTHER|Month 12|Kaplan-Meier|0.9|||||TWO_SIDED|90.0|-3.4|5.1|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||5.1|-3.4|
70852087|NCT01888432|141192674|OTHER|Month 24|Kaplan-Meier|1.0|||||TWO_SIDED|90.0|-3.6|5.6|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||5.6|-3.6|
71109058|NCT02765399|141723696|OTHER|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||||||0.018
71109059|NCT02765399|141723697|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71109060|NCT02765399|141723697|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
71109061|NCT02765399|141723698|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71109062|NCT02765399|141723698|OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
70852088|NCT01888432|141192675|OTHER|graft loss at month 24|Kaplan-Meier|-0.8|||||TWO_SIDED|90.0|-2.1|0.5|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||0.5|-2.1|
71109063|NCT02765399|141723699|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71109064|NCT02765399|141723699|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
71109065|NCT02765399|141723700|OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
71109066|NCT02765399|141723700|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
71109067|NCT02765399|141723701|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71109068|NCT02765399|141723701|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
71109069|NCT02765399|141723702|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71109070|NCT02765399|141723702|OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
71109071|NCT02765399|141723703|OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||||||0.017
71109072|NCT02765399|141723703|OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
71109073|NCT02765399|141723704|OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||||||0.017
71109074|NCT02765399|141723704|OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
71109075|NCT02765399|141723705|OTHER|||||||0.068|||||||Wilcoxon (Mann-Whitney)|||||||0.068
71109076|NCT02765399|141723705|OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
71109077|NCT00768261|141723707|OTHER|||||||0.095|TWO_SIDED|95.0|||||ANOVA|df= 3,92||||||0.095
71109078|NCT00768261|141723708|OTHER|||||||0.066|TWO_SIDED|95.0|||||ANOVA|||"There would be a treatment effect on the changes of hippocampal measures over time.~Repeated measures ANOVA on hippocampal volume slopes with hemisphere as a within-subject repeated factor, and treatment group as the main effect."||||0.066
71109079|NCT00768261|141723708|OTHER|||||||0.009|TWO_SIDED|95.0|||||ANOVA|||"There would be a treatment effect on the changes of hippocampal measures over time.~Repeated measures ANOVA on hippocampal volume slopes with hemisphere as a within-subject repeated factor, and treatment group as the main effect."||||0.009
71109080|NCT00768261|141723708|OTHER|||||||0.3|TWO_SIDED|95.0|||||ANOVA|||"There would be a treatment effect on the changes of hippocampal measures over time.~Repeated measures ANOVA on hippocampal volume slopes with hemisphere as a within-subject repeated factor, and treatment group as the main effect."||||0.30
71109081|NCT00768261|141723708|OTHER|||||||0.0288|TWO_SIDED|95.0|||||Repeated Measures ANOVA|||RM-ANOVA on hippocampal volume slope||||0.0288
71025994|NCT02637557|141559147|SUPERIORITY||LS Mean Difference|-0.045||||0.7024|TWO_SIDED|95.0|-0.279|0.188||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.188|-0.279|0.7024
71109082|NCT02525679|141723726|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.5968|STANDARD_ERROR_OF_MEAN|0.1047|||TWO_SIDED|95.0|1.3784|1.8151|||||Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error (SE) of the mean is actually SE of the slope.|Dose proportionality in plasma for Cmax (log-transformed scale) was explored based on the linear regression model.||1.8151|1.3784|
70935330|NCT03052517|141371557|OTHER||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.41|0.97|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / Placebo||0.97|0.41|
71025995|NCT02637557|141559147|SUPERIORITY||LS Mean Difference|-0.115||||0.3173|TWO_SIDED|95.0|-0.342|0.111||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.111|-0.342|0.3173
71025996|NCT02637557|141559147|SUPERIORITY||LS Mean Difference|-0.151||||0.1906|TWO_SIDED|95.0|-0.378|0.076||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.076|-0.378|0.1906
71025997|NCT02637557|141559147|SUPERIORITY||LS Mean Difference|-0.183||||0.1177|TWO_SIDED|95.0|-0.412|0.046||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.046|-0.412|0.1177
71025998|NCT02637557|141559147|SUPERIORITY||LS Mean Difference|-0.05||||0.6936|TWO_SIDED|95.0|-0.297|0.198||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.198|-0.297|0.6936
71025999|NCT02637557|141559147|SUPERIORITY||LS Mean Difference|-0.096||||0.4466|TWO_SIDED|95.0|-0.343|0.152||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.152|-0.343|0.4466
71026000|NCT02637557|141559147|SUPERIORITY||LS Mean Difference|-0.155||||0.2225|TWO_SIDED|95.0|-0.405|0.095||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.095|-0.405|0.2225
71026001|NCT02637557|141559147|SUPERIORITY||LS Mean Difference|-0.052||||0.6764|TWO_SIDED|95.0|-0.297|0.193||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.193|-0.297|0.6764
71026002|NCT02637557|141559147|SUPERIORITY||LS Mean Difference|-0.061||||0.6243|TWO_SIDED|95.0|-0.306|0.184||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.184|-0.306|0.6243
71026003|NCT02637557|141559147|SUPERIORITY||LS Mean Difference|-0.156||||0.2151|TWO_SIDED|95.0|-0.403|0.091||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.091|-0.403|0.2151
71026004|NCT02637557|141559147|SUPERIORITY||LS Mean Difference|-0.096||||0.4611|TWO_SIDED|95.0|-0.351|0.16||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.160|-0.351|0.4611
71058644|NCT02448368|141623400|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|170.0|||||TWO_SIDED|90.0|147.0|195.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||195|147|
71058645|NCT02448368|141623400|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|170.0|||||TWO_SIDED|90.0|146.0|199.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||199|146|
71109083|NCT02525679|141723726|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.0207|STANDARD_ERROR_OF_MEAN|0.0261|||TWO_SIDED|95.0|0.9668|1.0747|||||Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error (SE) of the mean is actually SE of the slope.|Dose proportionality in plasma for Cmax (log-transformed scale) was explored based on the linear regression model.||1.0747|0.9668|
70852089|NCT01888432|141192676|OTHER|Month 12|Kaplan-Meier|0.7|||||TWO_SIDED|90.0|-2.5|3.8|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||3.8|-2.5|
70935331|NCT03052517|141371557|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.55|1.11|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / QAW039 150mg||1.11|0.55|
71026005|NCT02637557|141559147|SUPERIORITY||LS Mean Difference|-0.139||||0.2849|TWO_SIDED|95.0|-0.394|0.116||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.116|-0.394|0.2849
71026006|NCT02637557|141559147|SUPERIORITY||LS Mean Difference|-0.228||||0.0833|TWO_SIDED|95.0|-0.485|0.03||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.030|-0.485|0.0833
71026007|NCT02637557|141559147|SUPERIORITY||LS Mean Difference|-0.017||||0.8955|TWO_SIDED|95.0|-0.277|0.242||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.242|-0.277|0.8955
71058646|NCT02448368|141623400|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|129.0|||||TWO_SIDED|90.0|114.0|146.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||146|114|
71058647|NCT02448368|141623401|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|161.0|||||TWO_SIDED|90.0|139.0|187.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||187|139|
71058648|NCT02448368|141623401|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|159.0|||||TWO_SIDED|90.0|135.0|188.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||188|135|
71058649|NCT02448368|141623401|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|131.0|||||TWO_SIDED|90.0|116.0|147.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||147|116|
71058650|NCT02448368|141623403|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|99.4|||||TWO_SIDED|90.0|88.3|112.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||112|88.3|
71058651|NCT02448368|141623403|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|99.9|||||TWO_SIDED|90.0|85.5|117.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||117|85.5|
71058652|NCT02448368|141623403|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|116.0|||||TWO_SIDED|90.0|94.8|143.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||143|94.8|
71058653|NCT02448368|141623404|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|107.0|||||TWO_SIDED|90.0|98.3|116.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||116|98.3|
71058654|NCT02448368|141623404|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|104.0|||||TWO_SIDED|90.0|95.0|113.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||113|95.0|
71058655|NCT02448368|141623404|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170|Geometric Least Squares mean Ratio|115.0|||||TWO_SIDED|90.0|95.3|140.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||140|95.3|
71058656|NCT02448368|141623405|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170|Geometric Least Squares mean Ratio|107.0|||||TWO_SIDED|90.0|98.1|116.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||116|98.1|
71058657|NCT02448368|141623405|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170|Geometric Least Squares mean Ratio|103.0|||||TWO_SIDED|90.0|94.6|113.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||113|94.6|
71058658|NCT02448368|141623405|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170|Geometric Least Squares mean Ratio|113.0|||||TWO_SIDED|90.0|93.3|137.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||137|93.3|
71058659|NCT02890355|141623410|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.28|TWO_SIDED|95.0|0.85|1.78||a priori threshold for statistical significance, one sided p=0.02|Log Rank|||||1.78|0.85|0.28
71058660|NCT02890355|141623412|SUPERIORITY||Hazard Ratio (HR)|1.39||||0.09|TWO_SIDED|95.0|0.96|2.02|||Log Rank|||||2.02|0.96|0.09
70852090|NCT01888432|141192676|OTHER|Month 24|Kaplan-Meier|2.3|||||TWO_SIDED|90.0|-2.1|6.6|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||6.6|-2.1|
70852091|NCT01888432|141192677|OTHER|Month 12|Kaplan-Meier|0.7|||||TWO_SIDED|90.0|-2.5|3.8|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||3.8|-2.5|
70852092|NCT01888432|141192677|OTHER|Month 24|Kaplan-Meier|3.0|||||TWO_SIDED|90.0|-1.1|7.2|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||7.2|-1.1|
70852093|NCT01888432|141192677|OTHER|Month 24 (On-treatment death)|Kaplan-Meier|0.7|||||TWO_SIDED|90.0|-2.5|3.9|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||3.9|-2.5|
70852094|NCT01888432|141192678|OTHER||Risk Difference (RD)|0.7|||||TWO_SIDED|90.0|-3.9|5.3|||||Month 12|||5.3|-3.9|
71058661|NCT01128179|141623419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1121||||0.3186|TWO_SIDED|95.0|-0.3389|0.1146||The a priori significance level was 5%. There was no adjustment for multiple comparisons.|ANCOVA|||Assuming that the natural logarithm transformed serum intact FGF-23 is normally distributed with a mean of 3.5 and a standard deviation of 0.46, 33 subjects randomised 2:1 (lanthanum carbonate to placebo) will be sufficient to detect with 80% power at the 5% 2-sided significance level a decrease of 0.5 in the mean difference (placebo minus lanthanum carbonate) of the log-transformed data at Week 12.||0.1146|-0.3389|0.3186
71058662|NCT01128179|141623420|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.54||||0.2995|TWO_SIDED|95.0|-6.15|19.23||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of serum iPTH at Week 12 (LOCF) in an analysis of covariance (ANCOVA) with treatment as a factor and the baseline iPTH as a covariate. The study was not powered for the analysis of this parameter.||19.23|-6.15|0.2995
71058663|NCT01128179|141623421|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.11||||0.3252|TWO_SIDED|95.0|-5.36|15.57||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of 1,25-Dihydroxy Vitamin D at Week 12 (LOCF) when utilizing an analysis of covariance (ANCOVA) with treatment as a factor and the baseline 1,25-Dihydroxy Vitamin D as a covariate. The study was not powered for the analysis of this parameter.||15.57|-5.36|0.3252
71058664|NCT01128179|141623422|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.7||||0.1459|TWO_SIDED|95.0|-8.845|1.403||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of Urinary Fractional Excretion of Phosphate at Week 12 (LOCF) when utilizing an analysis of covariance (ANCOVA) with treatment as a factor and the baseline Urinary Fractional Excretion of Phosphate as a covariate. The study was not powered for the analysis of this parameter.||1.403|-8.845|0.1459
71058665|NCT01128179|141623423|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.0297||||0.6134|TWO_SIDED|95.0|-0.1492|0.0897||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of Serum Phosphate at Week 12 (LOCF) in an analysis of covariance (ANCOVA) with treatment as a factor and the baseline Serum Phosphate as a covariate. The study was not powered for the analysis of this parameter||0.0897|-0.1492|0.6134
71058666|NCT01128179|141623424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0294||||0.5636|TWO_SIDED|95.0|-0.0739|0.1328||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of Serum Total Calcium at Week 12 (LOCF) in an analysis of covariance (ANCOVA) with treatment as a factor and the baseline Serum Total Calcium as a covariate. The study was not powered for the analysis of this parameter.||0.1328|-0.0739|0.5636
71058667|NCT01128179|141623425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.0129||||0.922|TWO_SIDED|95.0|-0.2811|0.2553||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of Calcium-Phosphate Product at Week 12 (LOCF) in an analysis of covariance (ANCOVA) with treatment as a factor and the baseline Calcium-Phosphate Product as a covariate.||0.2553|-0.2811|0.9220
71058668|NCT00720382|141623427|SUPERIORITY_OR_OTHER|||||||0.783||95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Overall baseline score||||0.783
70935332|NCT03052517|141371558|OTHER||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.47|2.23|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 150mg / Placebo||2.23|0.47|
71058669|NCT00720382|141623427|SUPERIORITY_OR_OTHER|||||||0.971|TWO_SIDED|95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Change from baseline to Month 1||||0.971
71058670|NCT00720382|141623427|SUPERIORITY_OR_OTHER|||||||0.206|TWO_SIDED|95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Change from baseline to Month 3||||0.206
71058671|NCT00720382|141623427|SUPERIORITY_OR_OTHER|||||||0.111||95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Change from baseline to Month 6||||0.111
71058672|NCT00720382|141623427|SUPERIORITY_OR_OTHER|||||||0.181||95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Change from baseline to Month 9||||0.181
71058673|NCT00720382|141623427|SUPERIORITY_OR_OTHER|||||||0.037|||||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Change from Baseline to Month 12/Early Term||||0.037
70852095|NCT01888432|141192678|OTHER||Risk Difference (RD)|2.1|||||TWO_SIDED|90.0|-3.0|7.2|||||Month 24|||7.2|-3.0|
70935333|NCT03052517|141371558|OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.59|2.64|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / Placebo||2.64|0.59|
70935334|NCT03052517|141371558|OTHER||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.7|2.1|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / QAW039 150mg||2.10|0.70|
71058674|NCT04460885|141623428|NON_INFERIORITY|The response and change from baseline in response after 52 weeks are analysed using an analysis of covariance (ANCOVA) model with treatment and region as fixed factors, and baseline response as covariate.|Treatment difference|-0.19|||<|0.0001|TWO_SIDED|95.0|-0.36|-0.03|||ANCOVA|||||-0.03|-0.36|<0.0001
71058675|NCT03956355|141623491|SUPERIORITY||Risk Ratio (RR)|5.78|||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
71058676|NCT03956355|141623492|SUPERIORITY||Risk Ratio (RR)|2.76|||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
71058677|NCT03956355|141623493|SUPERIORITY||Risk Ratio (RR)|2.68||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0001
71058678|NCT03956355|141623494|SUPERIORITY||Least squares mean difference|-3.28|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71058679|NCT03956355|141623495|SUPERIORITY||Risk Ratio (RR)|8.54||||0.0005|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0005
71058680|NCT00733005|141623584|SUPERIORITY_OR_OTHER_LEGACY|||||||0.102||95.0|||||ANCOVA|||||||0.102
71058681|NCT00733005|141623585|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019||95.0|||||ANCOVA|||||||0.019
71058682|NCT00266630|141623608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|||||TWO_SIDED|95.0|-4.1|-1.9||||||||-1.90|-4.10|
71058683|NCT00266630|141623612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.8|||||TWO_SIDED|95.0|-25.58|-14.06||||||||-14.06|-25.58|
71058684|NCT02548156|141623856|SUPERIORITY_OR_OTHER||Ratio of LS mean|1.52|||<|0.0001|TWO_SIDED|95.0||||From ANCOVA of log transformed data: subject (random), treatment (fixed) and period (fixed) as factors, participant-level baseline and period-level baseline minus participant-level baseline as covariates.|ANCOVA||Treatment difference from ANCOVA of log transformed data. This therefore represents the ratio of the first named treatment to the second named treatment. A ratio \>1 favors the first named treatment.|Test and Reference dentifrice combined vs. Comparator dentifrice||||<0.0001
71058685|NCT01068262|141623860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|69.2|||||TWO_SIDED|90.0|50.9|80.2|||Linear mixed effect model|Back-transformed least squares estimates and confidence intervals from a linear mixed effect model were performed on natural log-transformed values.||||80.2|50.9|
71058686|NCT01068262|141623860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|90.0|-14.7|14.9|||Linear mixed effects model|Back-transformed least squares estimates and confidence intervals from a linear mixed effect model were performed on natural log-transformed values.||||14.9|-14.7|
71058687|NCT01068262|141623861|SUPERIORITY_OR_OTHER||Estimate|0.9|||||TWO_SIDED|90.0|0.75|1.07||Hypothesis: Following 4 weeks of Qw oral dosing of Odanacatib 50 mg, there is no clinically important difference in the true GMR (male/postmenopausal female) of the AUC0-168hr. The GMR is contained within the interval (0.4, 2.0).|Geometric Mean Ratio (GMR); male/female|||||1.07|0.75|
71058688|NCT01068262|141623862|SUPERIORITY_OR_OTHER||GMR|0.93|||||TWO_SIDED|90.0|0.82|1.04|||GMR|||||1.04|0.82|
71058689|NCT01068262|141623863|SUPERIORITY_OR_OTHER||Estimate|0.95|||||TWO_SIDED|90.0|0.66|1.35|||GMR|||||1.35|0.66|
71058690|NCT01153425|141623870|OTHER|unpaired t-test for the difference of the means between the two arms|||||>|0.05|||||||t-test, 2 sided|||paired t-test for change from baseline to 24 months||||>0.05
71058691|NCT01232452|141623871|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.848|TWO_SIDED|95.0|0.73|1.47|||Log Rank|||||1.47|0.73|0.848
70852096|NCT01888432|141192679|OTHER||Risk Ratio (RR)|-0.7|||||TWO_SIDED|90.0|-4.5|3.1|||||Month 12|||3.1|-4.5|
70852097|NCT01888432|141192679|OTHER||Risk Ratio (RR)|0.0|||||TWO_SIDED|90.0|-4.2|4.2|||||Month 24|||4.2|-4.2|
70852098|NCT01888432|141192683|OTHER||Difference in Kaplan-Meier estimate|5.4|||||TWO_SIDED|95.0|-19.9|30.6|||||Composite endpoint|||30.6|-19.9|
71026008|NCT02637557|141559147|SUPERIORITY||LS Mean Difference|-0.052||||0.6916|TWO_SIDED|95.0|-0.312|0.207||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.207|-0.312|0.6916
71026009|NCT02637557|141559147|SUPERIORITY||LS Mean Difference|-0.159||||0.2345|TWO_SIDED|95.0|-0.421|0.103||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.103|-0.421|0.2345
71058692|NCT01232452|141623872|SUPERIORITY|||||||0.338|||||||Fisher Exact|||||||0.338
71058693|NCT05024747|141623883|OTHER||Ratio T/R|96.68|||||TWO_SIDED|90.0|90.0|103.85||||||Statistical comparison was analyzed between Test vs Reference based on Baseline Adjusted Data.||103.85|90.00|
71058694|NCT05024747|141623884|OTHER||Ratio T/R|92.37|||||TWO_SIDED|90.0|85.45|99.84||||||Statistical comparison was analyzed between Test vs Reference based on Baseline Adjusted Data.||99.84|85.45|
71058695|NCT05024747|141623885|OTHER||Ratio T/R|92.54|||||TWO_SIDED|90.0|85.63|100.01||||||Statistical comparison was analyzed between Test vs Reference based on Baseline Adjusted Data.||100.01|85.63|
71058696|NCT05024747|141623886|OTHER||Hodges- Lehmann's median difference|-0.0192||||0.0833|TWO_SIDED|95.0|-0.0542|0.0044|||Wilcoxon Signed Rank Test|||Statistical comparison was analyzed between Test vs Reference.||0.0044|-0.0542|0.0833
71058697|NCT05024747|141623887|OTHER||Hodges- Lehmann's median difference|-6.0||||0.0205|TWO_SIDED|95.0|-10.5|0.0|||Wilcoxon Signed Rank Test|||Statistical comparison was analyzed between Test vs Reference.||0.0000|-10.5000|0.0205
71058698|NCT05024747|141623888|OTHER||Hodges- Lehmann's median difference|0.3225||||0.0946|TWO_SIDED|95.0|-0.0949|0.681|||Wilcoxon Signed Rank Test|||Statistical comparison was analyzed between Test vs Reference.||0.6810|-0.0949|0.0946
71058699|NCT03022370|141623891|SUPERIORITY||Odds Ratio (OR)|0.92|||=|0.686|TWO_SIDED|95.0|0.62|1.37|||Regression, Logistic|||||1.37|0.62|=0.686
71058700|NCT03022370|141623891|SUPERIORITY||Odds Ratio (OR)|0.71|||=|0.032|TWO_SIDED|95.0|0.51|0.97|||Regression, Logistic|||||0.97|0.51|=0.032
71058701|NCT03022370|141623892|SUPERIORITY||Odds Ratio (OR)|0.9||||0.555|TWO_SIDED|95.0|0.64|1.28|||Regression, Logistic|||||1.28|0.64|0.555
71058702|NCT03022370|141623892|SUPERIORITY||Odds Ratio (OR)|0.74||||0.072|TWO_SIDED|95.0|0.54|1.03|||Regression, Logistic|||||1.03|0.54|0.072
71058703|NCT03022370|141623893|SUPERIORITY||Odds Ratio (OR)|0.93||||0.672|TWO_SIDED|95.0|0.66|1.31|||Regression, Logistic|||||1.31|0.66|0.672
71058704|NCT03022370|141623893|SUPERIORITY||Odds Ratio (OR)|0.7||||0.019|TWO_SIDED|95.0|0.52|0.94|||Regression, Logistic|||||0.94|0.52|0.019
71058705|NCT03022370|141623894|SUPERIORITY||Slope|-0.01||||0.984|TWO_SIDED|95.0|-0.88|0.86|||Regression, Linear|||||0.86|-0.88|0.984
70852099|NCT01888432|141192683|OTHER||Difference in Kaplan-Meier estimate|6.7|||||TWO_SIDED|95.0|-6.0|19.3|||||On-treatment composite endpoint|||19.3|-6.0|
70852100|NCT01888432|141192683|OTHER||Difference in Kaplan-Meier estimate|2.0|||||TWO_SIDED|95.0|-24.6|28.7|||||Graft loss/death|||28.7|-24.6|
70852101|NCT01888432|141192683|OTHER||Difference in Kaplan-Meier estimate|14.4|||||TWO_SIDED|95.0|-4.2|33.1|||||tBPAR|||33.1|-4.2|
70852102|NCT01888432|141192683|OTHER||Difference in Kaplan-Meier estimate|11.1|||||TWO_SIDED|95.0|-9.4|31.6|||||Death|||31.6|-9.4|
70935335|NCT03052517|141371559|OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.56|2.56|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 150mg / Placebo||2.56|0.56|
70935336|NCT03052517|141371559|OTHER||Hazard Ratio (HR)|1.33|||||TWO_SIDED|95.0|0.67|2.95|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / Placebo||2.95|0.67|
71026010|NCT02637557|141559147|SUPERIORITY||LS Mean Difference|-0.043||||0.7466|TWO_SIDED|95.0|-0.304|0.218||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.218|-0.304|0.7466
70852103|NCT01888432|141192683|OTHER||Difference in Kaplan-Meier estimate|3.2|||||TWO_SIDED|95.0|-28.9|35.2|||||AR|||35.2|-28.9|
70852104|NCT01888432|141192683|OTHER||Difference in Kaplan-Meier estimate|14.4|||||TWO_SIDED|95.0|-4.2|33.1|||||tAR|||33.1|-4.2|
70852105|NCT01888432|141192683|OTHER||Difference in Kaplan-Meier estimate|14.9|||||TWO_SIDED|95.0|-22.3|52.1|||||BPR|||52.1|-22.3|
70852106|NCT01888432|141192683|OTHER||Difference in Kaplan-Meier estimate|3.2|||||TWO_SIDED|95.0|-28.9|35.2|||||BPAR|||35.2|-28.9|
70852107|NCT01888432|141192684|OTHER||Mean Difference (Final Values)|-10.01|STANDARD_ERROR_OF_MEAN|22.059|||TWO_SIDED|95.0|-59.91|39.89||||||||39.89|-59.91|
70852108|NCT03054129|141192685|SUPERIORITY|||||||0.866|||||||Wilcoxon (Mann-Whitney)|||||||0.866
70935337|NCT03052517|141371559|OTHER||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.7|1.96|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / QAW039 150mg||1.96|0.70|
71026011|NCT02637557|141559147|SUPERIORITY||LS Mean Difference|-0.176||||0.1843|TWO_SIDED|95.0|-0.437|0.084||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.084|-0.437|0.1843
70852109|NCT03054129|141192686|SUPERIORITY|||||||0.361|||||||Wilcoxon (Mann-Whitney)|||||||0.361
70852110|NCT03054129|141192687|SUPERIORITY|||||||0.565|||||||Wilcoxon (Mann-Whitney)|||||||0.565
70852111|NCT03054129|141192688|OTHER|||||||0|||||||Wilcoxon (Mann-Whitney)|||||||0.000
70852112|NCT03054129|141192689|OTHER|||||||0|||||||Wilcoxon (Mann-Whitney)|||||||0.000
70852113|NCT03054129|141192690|SUPERIORITY|||||||0.357|||||||Wilcoxon (Mann-Whitney)|||||||0.357
70852114|NCT03054129|141192691|SUPERIORITY|||||||0.715|||||||Wilcoxon (Mann-Whitney)|||||||0.715
70852115|NCT03054129|141192692|SUPERIORITY|||||||0.978|||||||Wilcoxon (Mann-Whitney)|||||||0.978
71058706|NCT03022370|141623894|SUPERIORITY||Slope|0.06||||0.839|TWO_SIDED|95.0|-0.51|0.63|||Regression, Linear|||||0.63|-0.51|0.839
71058707|NCT03022370|141623895|SUPERIORITY||Slope|0.97|||<|0.0001|TWO_SIDED|95.0|0.43|1.51|||Tobit|Log + 1 performed on data||||1.51|0.43|<0.0001
71058708|NCT03022370|141623895|SUPERIORITY||Slope|0.21||||0.521|TWO_SIDED|95.0|-0.42|0.83|||Tobit|Log plus 1 to transform data||||0.83|-0.42|0.521
71058709|NCT03022370|141623896|SUPERIORITY||Slope|0.25||||0.718|TWO_SIDED|95.0|-1.09|1.58|||Regression, Linear|||||1.58|-1.09|0.718
71058710|NCT03022370|141623896|SUPERIORITY||Slope|-0.3||||0.712|TWO_SIDED|95.0|-1.87|1.28|||Regression, Linear|||||1.28|-1.87|0.712
70852116|NCT03054129|141192693|SUPERIORITY|||||||0.191|||||||Wilcoxon (Mann-Whitney)|||||||0.191
70852117|NCT03054129|141192694|SUPERIORITY|||||||0.097|||||||Wilcoxon (Mann-Whitney)|||||||0.097
70852118|NCT03054129|141192695|SUPERIORITY|||||||0.339|||||||Wilcoxon (Mann-Whitney)|||||||0.339
70852119|NCT03054129|141192696|SUPERIORITY|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
70852120|NCT03054129|141192697|SUPERIORITY|||||||0.933|||||||Wilcoxon (Mann-Whitney)|||||||0.933
70852121|NCT03054129|141192698|SUPERIORITY|||||||0.136|||||||Wilcoxon (Mann-Whitney)|||||||0.136
70852122|NCT03054129|141192699|SUPERIORITY|||||||0.673|||||||Wilcoxon (Mann-Whitney)|||||||0.673
70852123|NCT03054129|141192700|SUPERIORITY|||||||0.715|||||||Wilcoxon (Mann-Whitney)|||||||0.715
70852124|NCT03054129|141192701|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.040
70852125|NCT03054129|141192702|SUPERIORITY|||||||0.779|||||||Wilcoxon (Mann-Whitney)|||||||0.779
70852126|NCT03054129|141192703|SUPERIORITY|||||||0.152|||||||Wilcoxon (Mann-Whitney)|||||||0.152
70852127|NCT03054129|141192704|SUPERIORITY|||||||0.129|||||||Wilcoxon (Mann-Whitney)|||||||0.129
70852128|NCT03054129|141192705|SUPERIORITY|||||||0.384|||||||Wilcoxon (Mann-Whitney)|||||||0.384
70852129|NCT03054129|141192706|SUPERIORITY|||||||0.978|||||||Wilcoxon (Mann-Whitney)|||||||0.978
70852130|NCT03054129|141192707|SUPERIORITY|||||||0.715|||||||Wilcoxon (Mann-Whitney)|||||||0.715
70852131|NCT03054129|141192708|SUPERIORITY|||||||0.546|||||||Wilcoxon (Mann-Whitney)|||||||0.546
70852132|NCT03054129|141192709|SUPERIORITY|||||||0.933|||||||Wilcoxon (Mann-Whitney)|||||||0.933
70852133|NCT03054129|141192710|SUPERIORITY|||||||0.684|||||||Wilcoxon (Mann-Whitney)|||||||0.684
70852134|NCT03054129|141192711|SUPERIORITY|||||||0.112|||||||Wilcoxon (Mann-Whitney)|||||||0.112
70852135|NCT03054129|141192712|SUPERIORITY|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
70852136|NCT03054129|141192713|SUPERIORITY|||||||0.633|||||||Wilcoxon (Mann-Whitney)|||||||0.633
70852137|NCT03054129|141192714|SUPERIORITY|||||||0.736|||||||Wilcoxon (Mann-Whitney)|||||||0.736
70852138|NCT03054129|141192715|SUPERIORITY|||||||0.227|||||||Wilcoxon (Mann-Whitney)|||||||0.227
70852139|NCT03054129|141192716|SUPERIORITY|||||||0.109|||||||Wilcoxon (Mann-Whitney)|||||||0.109
70852140|NCT03054129|141192717|SUPERIORITY|||||||0.844|||||||Wilcoxon (Mann-Whitney)|||||||0.844
70852141|NCT03054129|141192718|SUPERIORITY|||||||0.122|||||||Wilcoxon (Mann-Whitney)|||||||0.122
70852142|NCT03054129|141192719|SUPERIORITY|||||||0.715|||||||Wilcoxon (Mann-Whitney)|||||||0.715
71058711|NCT03022370|141623897|SUPERIORITY||Slope|-1.52||||0.067|TWO_SIDED|95.0|-3.14|0.11|||Regression, Linear|||||0.11|-3.14|0.067
71058712|NCT03022370|141623897|SUPERIORITY||Slope|-0.75||||0.398|TWO_SIDED|95.0|-2.48|0.99|||Regression, Linear|||||0.99|-2.48|0.398
71058713|NCT03022370|141623898|SUPERIORITY||Odds Ratio (OR)|1.29||||0.228|TWO_SIDED|95.0|0.85|1.97|||Regression, Logistic|||||1.97|0.85|0.228
70852143|NCT03054129|141192720|SUPERIORITY|||||||0.593|||||||Wilcoxon (Mann-Whitney)|||||||0.593
70935338|NCT03052517|141371560|SUPERIORITY||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.626|1.047|||Regression, Logistic|Logistic regression model: logit (proportion) = randomization stratum, treatment, severity of asthma, region as fixed effects||Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 150mg /Placebo||1.047|0.626|
71058714|NCT03022370|141623898|SUPERIORITY||Odds Ratio (OR)|0.86||||0.558|TWO_SIDED|95.0|0.53|1.41|||Regression, Logistic|||||1.41|0.53|0.558
71058715|NCT03022370|141623899|SUPERIORITY||Slope|0.14||||0.679|TWO_SIDED|95.0|-0.52|0.8|||Regression, Linear|||||0.80|-0.52|0.679
71058716|NCT03022370|141623899|SUPERIORITY||Slope|0.55||||0.08|TWO_SIDED|95.0|-0.07|1.16|||Regression, Linear|||||1.16|-0.07|0.08
71058717|NCT03022370|141623900|SUPERIORITY||Slope|-0.13||||0.81|TWO_SIDED|95.0|-1.21|0.95|||Regression, Linear|||||0.95|-1.21|0.810
71058718|NCT03022370|141623900|SUPERIORITY||Slope|-1.03||||0.041|TWO_SIDED|95.0|-2.01|-0.04|||Regression, Linear|||||-0.04|-2.01|0.041
71058719|NCT03022370|141623901|SUPERIORITY||Odds Ratio (OR)|1.14||||0.635|TWO_SIDED|95.0|0.67|1.92|||Regression, Logistic|||||1.92|0.67|0.635
71058720|NCT03022370|141623901|SUPERIORITY||Odds Ratio (OR)|0.72||||0.256|TWO_SIDED|95.0|0.41|1.27|||Regression, Logistic|||||1.27|0.41|0.256
71058721|NCT03022370|141623902|SUPERIORITY||Odds Ratio (OR)|1.16||||0.526|TWO_SIDED|95.0|0.73|1.84|||Regression, Logistic|||||1.84|0.73|0.526
71058722|NCT03022370|141623902|SUPERIORITY||Odds Ratio (OR)|1.02||||0.931|TWO_SIDED|95.0|0.67|1.56|||Regression, Logistic|||||1.56|0.67|0.931
70852144|NCT03054129|141192721|SUPERIORITY|||||||0.508|||||||Wilcoxon (Mann-Whitney)|||||||0.508
71058723|NCT03022370|141623903|SUPERIORITY||Odds Ratio (OR)|0.92||||0.691|TWO_SIDED|95.0|0.63|1.36|||Regression, Logistic|||||1.36|0.63|0.691
71058724|NCT03022370|141623903|SUPERIORITY||Odds Ratio (OR)|0.92||||0.692|TWO_SIDED|95.0|0.6|1.4|||Regression, Logistic|||||1.40|0.60|0.692
71058725|NCT03022370|141623904|SUPERIORITY||Slope|-0.31||||0.137|TWO_SIDED|95.0|-0.72|0.24|||Regression, Linear|||||0.24|-0.72|0.137
71058726|NCT03022370|141623904|SUPERIORITY||Slope|-0.09||||0.721|TWO_SIDED|95.0|-0.58|0.4|||Regression, Linear|||||0.40|-0.58|0.721
71058727|NCT03022370|141623905|SUPERIORITY||Slope|-0.23||||0.332|TWO_SIDED|95.0|-0.7|0.24|||Regression, Linear|||||0.24|-0.70|0.332
70935339|NCT03052517|141371560|SUPERIORITY||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.622|1.038|||Regression, Logistic|Logistic regression model: logit (proportion) = randomization stratum, treatment, severity of asthma, region as fixed effects||Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 450mg /Placebo||1.038|0.622|
71058728|NCT03022370|141623905|SUPERIORITY||Slope|-0.19||||0.468|TWO_SIDED|95.0|-0.71|0.32|||Regression, Linear|||||0.32|-0.71|0.468
71058729|NCT03022370|141623906|SUPERIORITY||Odds Ratio (OR)|1.3||||0.174|TWO_SIDED|95.0|0.89|1.9|||Regression, Logistic|||||1.90|0.89|0.174
71058730|NCT03022370|141623906|SUPERIORITY||Odds Ratio (OR)|1.49||||0.129|TWO_SIDED|95.0|0.89|2.5|||Regression, Logistic|||||2.50|0.89|0.129
71058731|NCT03022370|141623907|SUPERIORITY||Odds Ratio (OR)|1.3||||0.174|TWO_SIDED|95.0|0.89|1.9|||Regression, Logistic|||||1.90|0.89|0.174
71058732|NCT03022370|141623907|SUPERIORITY||Odds Ratio (OR)|0.96||||0.836|TWO_SIDED|95.0|0.64|1.43|||Regression, Logistic|||||1.43|0.64|0.836
71058733|NCT00699816|141623908|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.01|TWO_SIDED|95.0|0.43|0.94|||Log Rank|||||0.94|0.43|0.01
71058734|NCT00699816|141623909|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.21||||0.008|TWO_SIDED|95.0|0.06|0.75|||Log Rank|||||0.75|0.06|0.008
71058735|NCT00699816|141623910|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.19||||0.02|TWO_SIDED|95.0|0.04|0.87|||Log Rank|||||0.87|0.04|0.02
71058736|NCT01311687|141623916|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||<|0.001|TWO_SIDED|95.0|0.35|0.59|||Stratified Log Rank Test|Stratified by age, disease population, and prior number of anti myeloma therapy.|Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||0.59|0.35|<0.001
71058737|NCT01311687|141623917|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.39|0.61|||Stratified log-rank test|Stratified by age, disease population, and prior number of anti myeloma therapy.|Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||0.61|0.39|<0.001
71058738|NCT01311687|141623919|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53|||<|0.001|TWO_SIDED|95.0|0.37|0.74|||Log Rank||Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||0.74|0.37|<0.001
71058739|NCT01311687|141623920|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.009|TWO_SIDED|95.0|0.54|0.92|||Log Rank||Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||0.92|0.54|0.009
71058740|NCT01311687|141623921|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.005|TWO_SIDED|95.0|0.6|0.91|||Log Rank||Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||0.91|0.60|0.005
71058741|NCT01311687|141623922|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.53|||<|0.001|TWO_SIDED|95.0|3.19|17.77|||Fisher Exact||Odds ratio is for pomalidomide plus low-dose dexamethasone : high dose dexamethasone|||17.77|3.19|< 0.001
71058742|NCT01311687|141623923|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.44|||<|0.001|TWO_SIDED|95.0|3.32|21.42|||Fisher Exact||Odds ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||21.42|3.32|< 0.001
71058743|NCT01311687|141623924|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46|||<|0.001|TWO_SIDED|95.0|0.36|0.59|||Stratified Log Rank Test|Stratified by age, diseases population, and prior number of anti myeloma therapy.|Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||0.59|0.36|< 0.001
71058744|NCT01526655|141623940|SUPERIORITY|||||||0.011||||||Main effect over time p\<0.001; Interaction effect p=0.65. Threshold for statistical significance p\<0.05|ANOVA|||||||0.011
71058745|NCT01526655|141623941|SUPERIORITY|||||||0.03||||||"P-value main effect between groups. Effect over time p \< 0.0001. Interaction effect p 0.02.~Threshold for statistical significance p\<0.05."|ANOVA||||Tukey post hoc test (p-values): hsCRP time 4 p 0.02; hsCRP time 5 p \<0.001.|||0.03
71058746|NCT01526655|141623942|SUPERIORITY||||||<|0.01||||||"P-value main effect between groups. Effect over time p \< 0.0001. Interaction effect p \< 0.0001.~Threshold for statistical significance p \< 0.05."|ANOVA||||Tukey post hoc test (p-value): WBC time 3 p \< 0.0001.|||<0.01
71058747|NCT01526655|141623943|SUPERIORITY|||||||0.03|||||||ANOVA||||Tukey post hoc test (p-value): IL-6 time 3 p \< 0.01.|||0.03
70935340|NCT03052517|141371560|SUPERIORITY||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.821|1.2|||Regression, Logistic|Logistic regression model: logit (proportion) = randomization stratum, treatment, severity of asthma, region as fixed effects||Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 450mg /QAW039 150mg||1.200|0.821|
71058748|NCT01526655|141623944|SUPERIORITY|||||||0.03||||||"P-value main effect between groups. Effect over time p \< 0.0001. Interaction effect p \< 0.01.~Threshold for statistical significance p \< 0.05."|ANOVA||||Tukey post hoc test (p-value): CK time 4 p \< 0.0001.|||0.03
71058749|NCT01526655|141623945|SUPERIORITY|||||||0.06||||||"P-value main effect between groups. Effect over time p \< 0.0001. Interaction effect p \< 0.01.~Threshold for statistical significance p \< 0.05."|ANOVA||||Tukey post hoc test (p-value): cortisol time 3 p \< 0.0001.|||0.06
71058750|NCT01526655|141623946|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
71058751|NCT01526655|141623947|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
71058752|NCT02288325|141624019|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.0212|TWO_SIDED|95.0|0.33|0.92|||Log Rank|||||0.92|0.33|0.0212
71058753|NCT04020887|141624023|SUPERIORITY||Median Difference (Final Values)|6.0|||||TWO_SIDED|95.0|-6.01|18.01||||||Difference in time to PACU discharge determination from observation to interaction phase \[ Time Frame: 6 months\]: The difference in discharge readiness time between the observation and interaction phases will be compared.||18.01|-6.01|
71058754|NCT04020887|141624024|SUPERIORITY||Difference Between Proportions|29.8|||||TWO_SIDED|95.0|23.82|35.66||||||||35.66|23.82|
71058755|NCT04020887|141624025|SUPERIORITY||Difference Between Proportions|-2.67|||||TWO_SIDED|95.0|-8.18|3.02||||||||3.02|-8.18|
71109084|NCT02525679|141723728|SUPERIORITY_OR_OTHER_LEGACY||Slope|2.7123|STANDARD_ERROR_OF_MEAN|0.2525|||TWO_SIDED|95.0|2.1856|3.2389|||||Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error (SE) of the mean is actually SE of the slope.|Dose proportionality in plasma for AUC(0-tz) (log-transformed scale) was explored based on the linear regression model.||3.2389|2.1856|
70935341|NCT03052517|141371561|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.667|1.125|||Regression, Logistic|Logistic regression model: logit (proportion) = randomization stratum, treatment, severity of asthma, region as fixed effects||Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 150mg /Placebo||1.125|0.667|
70935342|NCT03052517|141371561|SUPERIORITY||Odds Ratio (OR)|0.83|||||TWO_SIDED|95.0|0.643|1.082|||Regression, Logistic|Logistic regression model: logit (proportion) = randomization stratum, treatment, severity of asthma, region as fixed effects||Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 450mg /Placebo||1.082|0.643|
70935343|NCT03052517|141371561|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.794|1.167|||Regression, Logistic|Logistic regression model: logit (proportion) = randomization stratum, treatment, severity of asthma, region as fixed effects||Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 450mg /QAW039 150mg||1.167|0.794|
71058756|NCT04020887|141624026|SUPERIORITY||Difference Between Proportions|13.03|||||TWO_SIDED|95.0|5.16|20.79||||||||20.79|5.16|
71058757|NCT04020887|141624027|SUPERIORITY||Difference Between Proportions|0.51|||||TWO_SIDED|95.0|-1.63|3.07||||||||3.07|-1.63|
71058758|NCT04020887|141624028|SUPERIORITY||Difference Between Proportions|7.9|||||TWO_SIDED|95.0|3.13|12.71||||||||12.71|3.13|
71058759|NCT02374346|141624056|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|3.23||||0.001|TWO_SIDED|95.0|2.04|5.13|||t-test, 2 sided|||Sevoflurane administration in developing postoperative headache||5.13|2.04|0.001
71058760|NCT02374346|141624056|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|1.85||||0.006|TWO_SIDED|95.0|1.19|2.84|||t-test, 2 sided|||Smoking as a factor for developing postoperative headache||2.84|1.19|0.006
71058761|NCT02374346|141624056|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|2.11||||0.008|TWO_SIDED|95.0|1.22|3.66|||t-test, 2 sided|||Intraoperative hypotension associated with postoperative headache in total sample||3.66|1.22|0.008
71058762|NCT02374346|141624056|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|1.85||||0.024|TWO_SIDED|95.0|1.08|3.15|||t-test, 2 sided|||Female gender as a factor for developing postoperative headache||3.15|1.08|0.024
71058763|NCT02374346|141624056|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|4.56||||0.005|TWO_SIDED|95.0|1.58|13.17|||t-test, 2 sided|||Association of female gender and postoperative headache||13.17|1.58|0.005
71058764|NCT02374346|141624056|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|3.79||||0.006|TWO_SIDED|95.0|1.48|9.72|||t-test, 2 sided|||Association of intraoperative hypotension and postoperative headache||9.72|1.48|0.006
71109085|NCT02525679|141723728|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.0003|STANDARD_ERROR_OF_MEAN|0.0253|||TWO_SIDED|95.0|0.9482|1.0525|||||Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error (SE) of the mean is actually SE of the slope.|Dose proportionality in plasma for AUC(0-tz) (log-transformed scale) was explored based on the linear regression model.||1.0525|0.9482|
71026012|NCT02637557|141559147|SUPERIORITY||LS Mean Difference|-0.267||||0.0471|TWO_SIDED|95.0|-0.531|-0.003||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.003|-0.531|0.0471
71026013|NCT02637557|141559148|SUPERIORITY||LS Mean Difference|0.088||||0.3258|TWO_SIDED|95.0|-0.088|0.265||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.265|-0.088|0.3258
71026014|NCT02637557|141559148|SUPERIORITY||LS Mean Difference|0.084||||0.3483|TWO_SIDED|95.0|-0.092|0.261||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.261|-0.092|0.3483
71026015|NCT02637557|141559148|SUPERIORITY||LS Mean Difference|0.022||||0.8055|TWO_SIDED|95.0|-0.156|0.201||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.201|-0.156|0.8055
71026016|NCT02637557|141559148|SUPERIORITY||LS Mean Difference|0.103||||0.3627|TWO_SIDED|95.0|-0.119|0.326||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.326|-0.119|0.3627
71026017|NCT02637557|141559148|SUPERIORITY||LS Mean Difference|0.087||||0.4404|TWO_SIDED|95.0|-0.135|0.31||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.310|-0.135|0.4404
71026018|NCT02637557|141559148|SUPERIORITY||LS Mean Difference|0.001||||0.9939|TWO_SIDED|95.0|-0.224|0.226||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.226|-0.224|0.9939
71026019|NCT02637557|141559148|SUPERIORITY||LS Mean Difference|-0.128||||0.2716|TWO_SIDED|95.0|-0.356|0.1||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.100|-0.356|0.2716
71026020|NCT02637557|141559148|SUPERIORITY||LS Mean Difference|-0.116||||0.3175|TWO_SIDED|95.0|-0.345|0.112||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.112|-0.345|0.3175
71026021|NCT02637557|141559148|SUPERIORITY||LS Mean Difference|-0.252||||0.0325|TWO_SIDED|95.0|-0.483|-0.021||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.021|-0.483|0.0325
71026022|NCT02637557|141559148|SUPERIORITY||LS Mean Difference|-0.169||||0.1769|TWO_SIDED|95.0|-0.415|0.077||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.077|-0.415|0.1769
71026023|NCT02637557|141559148|SUPERIORITY||LS Mean Difference|-0.188||||0.1343|TWO_SIDED|95.0|-0.434|0.058||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.058|-0.434|0.1343
71026024|NCT02637557|141559148|SUPERIORITY||LS Mean Difference|-0.295||||0.0203|TWO_SIDED|95.0|-0.544|-0.046||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||-0.046|-0.544|0.0203
70935344|NCT01640288|141371566|OTHER|t-test|Mean Difference (Final Values)|-0.145|STANDARD_ERROR_OF_MEAN|0.0349|<|0.0001|TWO_SIDED|||||Not adjusted for multiple comparisons|t-test, 2 sided|||||||<0.0001
71026025|NCT02637557|141559148|SUPERIORITY||LS Mean Difference|-0.152||||0.2543|TWO_SIDED|95.0|-0.415|0.11||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.110|-0.415|0.2543
70935345|NCT01640288|141371567|OTHER|t-test|Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
70935346|NCT04803734|141371569|EQUIVALENCE|To establish bioequivalence of albuterol under fasting conditions, the 90% confidence interval for the ratio of the geometric means between the products should fall within the FDA defined acceptance range of 80.00%-125.00% interval for ln-transformed Cmax.|Ratio of geometric least square mean|0.862||||0.0328|TWO_SIDED|90.0|0.807|0.922|||ANOVA|||||0.922|0.807|0.0328
71026026|NCT02637557|141559148|SUPERIORITY||LS Mean Difference|-0.142||||0.2892|TWO_SIDED|95.0|-0.405|0.121||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.121|-0.405|0.2892
71026027|NCT02637557|141559148|SUPERIORITY||LS Mean Difference|-0.306||||0.0243|TWO_SIDED|95.0|-0.571|-0.04||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||-0.040|-0.571|0.0243
71026028|NCT02637557|141559148|SUPERIORITY||LS Mean Difference|-0.059||||0.6471|TWO_SIDED|95.0|-0.312|0.194||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.194|-0.312|0.6471
71026029|NCT02637557|141559148|SUPERIORITY||LS Mean Difference|-0.106||||0.4123|TWO_SIDED|95.0|-0.359|0.148||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.148|-0.359|0.4123
71109086|NCT03958331|141723789|SUPERIORITY||Mean Difference (Final Values)|10.62|STANDARD_ERROR_OF_MEAN|3.38||0.002|TWO_SIDED|95.0|4.0|17.25|||ANCOVA|Model controlled for baseline adherence, resistance to peer influence, dose, active seizures, COVID timing, COVID Impact (3 items), and sex|||We also conducted a longitudinal mixed effects model for adherence over time, estimating a groupXtime interaction with the same covariates listed above and allowing for a non-linear effect.|17.25|4|0.002
71109087|NCT01911351|141723799|SUPERIORITY_OR_OTHER||kappa statistic|0.88|||<|0.001|TWO_SIDED|||||A priori threshold for statistical significance: p\< or = 0.05|Chi-squared|||A kappa statistic was performed for 75% of the group to assess inter-rater agreement of the perception of the success of the procedure.||||<0.001
70852145|NCT00130247|141192722|NON_INFERIORITY_OR_EQUIVALENCE|This two-sided equivalence trial compared the efficacy of 4 and 6 months of treatment. We assumed that the risk of relapse for patients in the 6 month arm was 3.5% and that an absolute difference of 5% (i.e. relapse rate of 8.5%) was clinically meaningful. For a level of significance of 0.05 and 80% power (two sided), we estimated that 284 evaluable subjects per arm were required.|Risk Difference (RD)|0.051||||||95.0|0.01|0.09|||Regression, Cox||Confidence interval for difference of binomial proportions adjusted with Hauck Anderson continuity correction.|Comparison of binomial proportion of relapse: Intention-to-treat||0.09|0.01|
70935347|NCT04803734|141371570|EQUIVALENCE|To establish bioequivalence of albuterol under fasting conditions, the 90% confidence interval for the ratio of the geometric means between the products should fall within the FDA defined acceptance range of 80.00%-125.00% interval for ln-transformed AUC(0-t).|Ratio of geometric least square mean|0.941|||<|0.0001|TWO_SIDED|90.0|0.909|0.976|||ANOVA|||||0.976|0.909|<0.0001
71026030|NCT02637557|141559148|SUPERIORITY||LS Mean Difference|-0.278||||0.0338|TWO_SIDED|95.0|-0.534|-0.021||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.021|-0.534|0.0338
71026031|NCT02637557|141559148|SUPERIORITY||LS Mean Difference|-0.095||||0.4841|TWO_SIDED|95.0|-0.362|0.172||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.172|-0.362|0.4841
71026032|NCT02637557|141559148|SUPERIORITY||LS Mean Difference|-0.152||||0.2627|TWO_SIDED|95.0|-0.419|0.115||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.115|-0.419|0.2627
71026033|NCT02637557|141559148|SUPERIORITY||LS Mean Difference|-0.311||||0.0241|TWO_SIDED|95.0|-0.581|-0.041||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.041|-0.581|0.0241
71026034|NCT02637557|141559148|SUPERIORITY||LS Mean Difference|-0.093||||0.4881|TWO_SIDED|95.0|-0.355|0.17||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.170|-0.355|0.4881
71026035|NCT02637557|141559148|SUPERIORITY||LS Mean Difference|-0.164||||0.2205|TWO_SIDED|95.0|-0.427|0.099||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.099|-0.427|0.2205
71026036|NCT02637557|141559148|SUPERIORITY||LS Mean Difference|-0.433||||0.0015|TWO_SIDED|95.0|-0.699|-0.168||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.168|-0.699|0.0015
71026037|NCT02637557|141559149|SUPERIORITY||LS Mean Difference|0.043||||0.6653|TWO_SIDED|95.0|-0.152|0.238||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.238|-0.152|0.6653
71026038|NCT02637557|141559149|SUPERIORITY||LS Mean Difference|0.15||||0.1327|TWO_SIDED|95.0|-0.046|0.345||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.345|-0.046|0.1327
71026039|NCT02637557|141559149|SUPERIORITY||LS Mean Difference|0.043||||0.6697|TWO_SIDED|95.0|-0.155|0.241||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.241|-0.155|0.6697
71058765|NCT02374346|141624056|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|3.86||||0.041|TWO_SIDED|95.0|1.06|14.06|||t-test, 2 sided|||Association of caffeine consumption and postoperative headache||14.06|1.06|0.041
71109088|NCT04422431|141723800|OTHER|||||||0.1002|||||||t-test, 2 sided|||||||0.1002
71026040|NCT02637557|141559149|SUPERIORITY||LS Mean Difference|0.021||||0.8598|TWO_SIDED|95.0|-0.21|0.251||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.251|-0.210|0.8598
71058766|NCT02374346|141624056|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test.Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|4.26||||0.001|TWO_SIDED|95.0|1.82|9.95|||t-test, 2 sided|||Association of sevoflurane administration and postoperative headache||9.95|1.82|0.001
71026041|NCT02637557|141559149|SUPERIORITY||LS Mean Difference|0.113||||0.3354|TWO_SIDED|95.0|-0.118|0.344||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.344|-0.118|0.3354
71109089|NCT02317627|141723833|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD PASI from baseline to Week 12.||||||0.0282||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0282
71026042|NCT02637557|141559149|SUPERIORITY||LS Mean Difference|0.055||||0.6429|TWO_SIDED|95.0|-0.179|0.289||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.289|-0.179|0.6429
71026043|NCT02637557|141559149|SUPERIORITY||LS Mean Difference|-0.101||||0.401|TWO_SIDED|95.0|-0.336|0.135||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.135|-0.336|0.4010
71026044|NCT02637557|141559149|SUPERIORITY||LS Mean Difference|-0.129||||0.2821|TWO_SIDED|95.0|-0.364|0.106||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.106|-0.364|0.2821
71026045|NCT02637557|141559149|SUPERIORITY||LS Mean Difference|-0.149||||0.2189|TWO_SIDED|95.0|-0.388|0.089||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.089|-0.388|0.2189
71026046|NCT02637557|141559149|SUPERIORITY||LS Mean Difference|-0.093||||0.4717|TWO_SIDED|95.0|-0.346|0.161||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.161|-0.346|0.4717
71026047|NCT02637557|141559149|SUPERIORITY||LS Mean Difference|-0.096||||0.4572|TWO_SIDED|95.0|-0.349|0.158||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.158|-0.349|0.4572
71026048|NCT02637557|141559149|SUPERIORITY||LS Mean Difference|-0.165||||0.2064|TWO_SIDED|95.0|-0.422|0.092||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.092|-0.422|0.2064
71026049|NCT02637557|141559149|SUPERIORITY||LS Mean Difference|-0.088||||0.4932|TWO_SIDED|95.0|-0.339|0.164||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.164|-0.339|0.4932
71026050|NCT02637557|141559149|SUPERIORITY||LS Mean Difference|-0.069||||0.5897|TWO_SIDED|95.0|-0.321|0.183||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.183|-0.321|0.5897
71026051|NCT02637557|141559149|SUPERIORITY||LS Mean Difference|-0.166||||0.2014|TWO_SIDED|95.0|-0.421|0.089||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.089|-0.421|0.2014
71026052|NCT02637557|141559149|SUPERIORITY||LS Mean Difference|-0.044||||0.7384|TWO_SIDED|95.0|-0.304|0.215||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.215|-0.304|0.7384
71026053|NCT02637557|141559149|SUPERIORITY||LS Mean Difference|-0.043||||0.7423|TWO_SIDED|95.0|-0.303|0.216||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.216|-0.303|0.7423
71026054|NCT02637557|141559149|SUPERIORITY||LS Mean Difference|-0.141||||0.2923|TWO_SIDED|95.0|-0.404|0.122||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.122|-0.404|0.2923
71026055|NCT02637557|141559149|SUPERIORITY||LS Mean Difference|-0.085||||0.5388|TWO_SIDED|95.0|-0.359|0.188||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.188|-0.359|0.5388
71026056|NCT02637557|141559149|SUPERIORITY||LS Mean Difference|0.008||||0.9565|TWO_SIDED|95.0|-0.266|0.281||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.281|-0.266|0.9565
71026057|NCT02637557|141559149|SUPERIORITY||LS Mean Difference|-0.099||||0.4848|TWO_SIDED|95.0|-0.376|0.179||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.179|-0.376|0.4848
71026058|NCT02637557|141559149|SUPERIORITY||LS Mean Difference|-0.164||||0.2523|TWO_SIDED|95.0|-0.445|0.117||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.117|-0.445|0.2523
71026059|NCT02637557|141559149|SUPERIORITY||LS Mean Difference|-0.112||||0.4356|TWO_SIDED|95.0|-0.393|0.17||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.170|-0.393|0.4356
71026060|NCT02637557|141559149|SUPERIORITY||LS Mean Difference|-0.199||||0.1706|TWO_SIDED|95.0|-0.485|0.086||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.086|-0.485|0.1706
71026061|NCT02637557|141559150|SUPERIORITY||LS Mean Difference|-0.02||||0.7689|TWO_SIDED|95.0|-0.155|0.115||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.115|-0.155|0.7689
71109090|NCT02317627|141723833|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID PASI from baseline to Week 12.||||||0.0035||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0035
71109091|NCT02317627|141723833|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg BID PASI from baseline to Week 12.||||||0.0261||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0261
71109092|NCT02317627|141723833|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change for all subjects' PASI from baseline to Week 12.|||||<|0.0001||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||< 0.0001
71109093|NCT02317627|141723834|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD PASI from baseline to Week 12.||||||0.0282||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0282
71109094|NCT02317627|141723834|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID PASI from baseline to Week 12.||||||0.0029||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0029
71109095|NCT02317627|141723834|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg BID PASI from baseline to Week 12.||||||0.0703||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0703
71109096|NCT02317627|141723834|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change of all subjects' PASI from baseline to Week 12.||||||0.0002||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0002
71109097|NCT02317627|141723839|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD from baseline to Week 4.||||||0.0064||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0064
70935348|NCT04803734|141371571|EQUIVALENCE|To establish bioequivalence of albuterol under fasting conditions, the 90% confidence interval for the ratio of the geometric means between the products should fall within the FDA defined acceptance range of 80.00%-125.00% interval for ln-transformed AUC(0-inf).|Ratio of geometric least square mean|0.942|||<|0.0001|TWO_SIDED|90.0|0.91|0.975|||ANOVA|||||0.975|0.910|<0.0001
71109098|NCT02317627|141723839|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID from baseline to Week 4.||||||0.0479||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0479
71109099|NCT02317627|141723839|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg BID from baseline to Week 4.||||||0.1513||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.1513
71109100|NCT02317627|141723839|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change Overall from baseline to Week 4.||||||0.0002||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0002
71109101|NCT02317627|141723840|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD from baseline to Week 8.||||||0.0137||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0137
70935349|NCT03775915|141371582|OTHER||||||>|0.05||||||p-value calculated for interaction between group and day|Linear Mixed Model|Linear mixed effects model adjusted for baseline, F(2,46) = 1.061, p \>0.05||||||>0.05
70935350|NCT03775915|141371583|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
70935351|NCT03883724|141371596|OTHER|ANCOVA between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome||||||0.3|||||||ANCOVA|between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome||Change in NPi pre- vs post-intervention comparing between group analysis||||0.3
70941713|NCT04748445|141383935|OTHER||Slope|-3.067|STANDARD_ERROR_OF_MEAN|1.053||0.0042|TWO_SIDED|90.0|-4.811|-1.323|||Mixed Models Analysis|||EE\_MFCC 1st order delta 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-3.||-1.323|-4.811|0.0042
71109102|NCT02317627|141723840|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID from baseline to Week 8.||||||0.0017||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0017
71109103|NCT02317627|141723840|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg BID from baseline to Week 8.||||||0.0743||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0743
71109104|NCT02317627|141723840|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change Overall from baseline to Week 8.|||||<|0.0001||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||< 0.0001
71109105|NCT02317627|141723841|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD from baseline to 4 weeks.||||||0.014||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0140
71109106|NCT02317627|141723841|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID from baseline to 4 weeks.||||||0.062||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0620
71109107|NCT02317627|141723841|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in 400 mg BID from baseline to 4 weeks.||||||0.262||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.2620
71109108|NCT02317627|141723841|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change of all subjects from baseline to 4 weeks.||||||0.0008||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0008
71109109|NCT02317627|141723841|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD from baseline to 8 weeks.||||||0.0137||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0137
71109110|NCT02317627|141723841|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID from baseline to 8 weeks.||||||0.0064||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0064
71109111|NCT02317627|141723841|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg BID from baseline to 8 weeks.||||||0.0743||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0743
71109112|NCT02317627|141723841|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change of all subjects from baseline to 8 weeks.|||||<|0.0001||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||< 0.0001
71109113|NCT02317627|141723846|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD from baseline to 12 weeks.||||||0.004||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.004
71109114|NCT02317627|141723846|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID from baseline to 12 weeks.||||||0.007||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.007
71109115|NCT02317627|141723846|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg BID from baseline to 12 weeks.||||||0.09||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.090
71109116|NCT02317627|141723846|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change Overall from baseline to 12 weeks.|||||<|0.001||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||< 0.001
71109117|NCT02317627|141723847|SUPERIORITY|||||||0.004||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.004
70852146|NCT00130247|141192725|SUPERIORITY_OR_OTHER||Incidence rate ratio|3.43||||||95.0|0.94|12.5|||Regression, Linear|||Rate of relapse at 1 year. All patients adherent with treatment and remaining in follow-up at 1 year were included in the calculation of the relapse incidence rate.||12.5|0.94|
71109118|NCT02317627|141723847|SUPERIORITY|||||||0.029||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.029
71109119|NCT02317627|141723847|SUPERIORITY|||||||0.084||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.084
71109120|NCT02317627|141723847|SUPERIORITY||||||<|0.001||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||< 0.001
71109121|NCT01088906|141723863|SUPERIORITY||Odds Ratio (OR)|34.0||||0.05|TWO_SIDED||||||Regression, Logistic|||||||0.05
71109122|NCT03384875|141723878|SUPERIORITY||Risk Difference (RD)|0.0||||0.517|TWO_SIDED||||||Chi-squared|||||||0.517
71109123|NCT03181971|141723885|SUPERIORITY||Odds Ratio (OR)|0.7||||0.68|TWO_SIDED|95.0|0.2|2.9|||Mixed Models Analysis|||Analysis of between group change from baseline to 7 months.||2.9|0.2|0.68
71109124|NCT03181971|141723885|SUPERIORITY||Odds Ratio (OR)|0.1||||0.017|TWO_SIDED|95.0|0.03|0.7|||Mixed Models Analysis|||Analysis of between group change from baseline to 15 months||0.7|0.03|0.017
71109125|NCT03181971|141723886|SUPERIORITY||Odds Ratio (OR)|0.4||||0.24|TWO_SIDED|95.0|0.07|2.0|||Mixed Models Analysis|||Analysis of between group change from baseline to 7 months.||2.0|0.07|.24
71109126|NCT03181971|141723886|SUPERIORITY||Odds Ratio (OR)|1.0||||0.98|TWO_SIDED|95.0|0.1|7.0|||Mixed Models Analysis|||Analysis of between group change from baseline to 15 months.||7.0|0.1|.98
71109127|NCT03181971|141723887|SUPERIORITY||Adjusted mean difference|0.2||||0.57|TWO_SIDED|95.0|-0.6|1.0|||Mixed Models Analysis|||Analysis of between group change from baseline to 7 months.||1.0|-0.6|0.57
71109128|NCT03181971|141723887|SUPERIORITY||Adjusted mean difference|-0.5||||0.4|TWO_SIDED|95.0|-1.5|0.6|||Mixed Models Analysis|||Analysis of between group change from baseline to 15 months.||0.6|-1.5|.40
70935352|NCT03883724|141371597|OTHER|ANCOVA between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome|||||<|0.01||||||Change in nocturia frequency pre- vs post-intervention comparing between groups BBTI vs IC|ANCOVA|between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome||Change in nocturia frequency pre- vs post-intervention comparing between group analysis||||<.01
70935353|NCT03883724|141371598|OTHER|ANCOVA between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome||||||0.3|||||||ANCOVA|ANCOVA between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome||between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome||||0.3
70935354|NCT00195819|141371599|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.1||||0.06||95.0|-0.5|40.7|||Chi-squared|||||40.7|-0.5|0.060
71026062|NCT02637557|141559150|SUPERIORITY||LS Mean Difference|0.034||||0.6287|TWO_SIDED|95.0|-0.103|0.17||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.170|-0.103|0.6287
71026063|NCT02637557|141559150|SUPERIORITY||LS Mean Difference|0.07||||0.3106|TWO_SIDED|95.0|-0.066|0.207||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.207|-0.066|0.3106
71026064|NCT02637557|141559151|SUPERIORITY||LS Mean Difference|0.0||||0.9961|TWO_SIDED|95.0|-0.1|0.101||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.101|-0.100|0.9961
71026065|NCT02637557|141559151|SUPERIORITY||LS Mean Difference|-0.008||||0.8829|TWO_SIDED|95.0|-0.109|0.094||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.094|-0.109|0.8829
71026066|NCT02637557|141559151|SUPERIORITY||LS Mean Difference|0.1||||0.0527|TWO_SIDED|95.0|-0.001|0.201||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.201|-0.001|0.0527
71026067|NCT01711021|141559171|SUPERIORITY||Least Square (LS) mean difference|-5.87|||<|0.001|TWO_SIDED|95.0|-6.76|-4.97|||Mixed Models Analysis|Mixed model repeated measure (MMRM) analysis for SKAMP total score in Double-Blind period||||-4.97|-6.76|< 0.001
71026068|NCT01711021|141559173|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
71026069|NCT03734237|141559178|EQUIVALENCE|Null Hypothesis: RR=1, Alternative hypothesis: RR not equal to 1|Risk Ratio (RR)|-26.7||||0.1412|TWO_SIDED|95.0|-73.7|7.6|||Chi-squared|||Relative vaccine effectiveness with the outcome laboratory confirmed influenza identified via surveillance and/or abstracted from clinical records.||7.6|-73.7|0.1412
70852147|NCT00130247|141192725|SUPERIORITY_OR_OTHER||Incident rate ratio|4.52||||||95.0|1.29|15.9|||Regression, Linear|||Rate of relapse at 2 years. All patients adherent with treatment and remaining in follow-up at 2 years were included in the calculation of the relapse incidence rate.||15.9|1.29|
70935355|NCT00195819|141371642|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.42||0.387||95.0|||||ANCOVA|||||||0.387
71026070|NCT03734237|141559178|EQUIVALENCE|Null Hypothesis: RR=1, Alternative hypothesis: RR not equal to 1.|Risk Ratio (RR)|-13.1||||0.4552|TWO_SIDED|95.0|-56.4|18.2|||Chi-squared|||Relative vaccine effectiveness with the outcome laboratory confirmed influenza identified via surveillance and/or abstracted from clinical records.||18.2|-56.4|0.4552
70935356|NCT02336958|141371654|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0
70935357|NCT02336958|141371655|SUPERIORITY_OR_OTHER|||||||0.459|TWO_SIDED||||||t-test, 2 sided|||||||0.459
70935358|NCT00822900|141371688|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.95||||0.35|TWO_SIDED|95.0|0.85|1.06|||Regression, Generalized linear|Adjusting for injury severity, sex, and age. the binomial distribution with the log link is used to estimate treatment effect as relative risk.|A risk ratio (equivalent to the relative risk) of less than 1.00 indicating fewer favorable outcomes in the progesterone group than in the placebo group.|Test of null hypothesis (equal proportions of subjects with favorable outcome in progesterone and placebo arms) versus alternative hypothesis (unequal proportions of subjects with favorable outcome in progesterone and placebo arms). Standard multiple imputation methods are used to account for missing data. The primary outcome measure is based on the stratified dichotomy approach.||1.06|0.85|0.35
70935359|NCT00822900|141371689|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.86|1.63|||||A hazard ratio of more than 1.00 indicating higher hazard of death from the progesterone group than in the placebo group.|The Cox proportional hazards model is used to compare these curves after adjustment for age, sex and injury severity.||1.63|0.86|
70935360|NCT00822900|141371691|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.03|||||TWO_SIDED|95.0|1.96|4.66|||||A risk ratio (equivalent to the relative risk) of more than 1.00 indicating more events in the progesterone group than in the placebo group.|||4.66|1.96|
71026071|NCT01844583|141559193|SUPERIORITY_OR_OTHER||LS Mean Ratio|1.14|||||TWO_SIDED|90.0|0.97|1.35|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.|||1.35|0.97|
71026072|NCT01844583|141559194|SUPERIORITY_OR_OTHER||LS Mean Ratio|1.25|||||TWO_SIDED|90.0|1.08|1.45|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.|||1.45|1.08|
71026073|NCT01844583|141559195|SUPERIORITY_OR_OTHER||LS Mean Ratio|1.28|||||TWO_SIDED|90.0|1.07|1.53|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.|||1.53|1.07|
71026074|NCT01844583|141559198|SUPERIORITY_OR_OTHER||LS Mean Ratio|1.03|||||TWO_SIDED|90.0|0.84|1.26|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.|||1.26|0.84|
71026075|NCT01844583|141559199|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.51|||||TWO_SIDED|90.0|0.41|0.62|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.|||0.62|0.41|
70935361|NCT04679675|141371700|SUPERIORITY||Risk Ratio (RR)|1.3||||0.05|TWO_SIDED|95.0|1.23|1.36|||Poisson Regression with GEE|||Primary analysis stratified by screening history. These results are for Screening-Adherent (population):Direct-Mail versus Education analysis.||1.36|1.23|0.05
70935362|NCT04679675|141371700|SUPERIORITY||Risk Ratio (RR)|1.07||||0.05|TWO_SIDED|95.0|1.02|1.12|||Poisson Regression with GEE|||Primary analysis stratified by screening history. These results are for Screening-Adherent (population):Opt-In versus Education analysis.||1.12|1.02|.05
71026076|NCT01844583|141559200|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.53|||||TWO_SIDED|90.0|0.41|0.7|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.|||0.70|0.41|
71026077|NCT01625377|141559206|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.34|||<|0.0001|TWO_SIDED|95.0|-21.34|-7.34|||ANCOVA|||||-7.34|-21.34|<0.0001
71026078|NCT01412541|141559219|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The evaluable sample size required for 90% power is 150 (50 Control plus 100 Test). This endpoint is not the sample-size driver of the study. Randomization of 476 subjects is expected to provide at least 405 evaluable subjects, after adjustment for up to 15% censoring) and approximately 99% power.||||||0.025|||||||Farrington and Manning|||"To assess if proportion of subjects with at least one safety event\* in the Test group is inferior or not inferior to that of Control group through 12-months Post index procedure (PPI) H0: The proportion of subjects with safety events in the Test group through 12-months PPI is clinically inferior to that of the Control group.~H1: The proportion of subjects with safety events in the Test group through 12-months PPI is clinically non-inferior to that of the Control group."||||0.025
71026079|NCT01412541|141559220|EQUIVALENCE|The statistical analysis is a likelihood ratio chi-square test for inequality of binomial proportions; the test is a two-sided test at α=0.05. The response variable in each subject will be the presence or absence of at least one efficacy event from the time following the index procedure through 12 months. The study evaluable sample size required for 90% power is approximately 405 subjects. After adjustment for 15% censoring through 12 months, the study size is 476.||||||0.05|||||||Chi-squared|The statistical analysis is a likelihood ratio chi-square test for inequality of binomial proportions; the test is a two-sided test.||"To assess whether the proportion of subjects with at least one efficacy event\* in the Test group is equal or not to that of Control group through 12-months post-index procedure.~H0: The proportion of subjects with efficacy events in the Control group through 12-months post-index procedure is equal to that of the Test group.~H1: The proportion of subjects with efficacy events in the Control group through 12-months post-index procedure is not equal to that of the Test group."||||0.05
71026080|NCT02833415|141559247|OTHER|Differences of Least Squares Means|Differences of Least Squares Means|0.9398|STANDARD_ERROR_OF_MEAN|0.2941||0.0053|TWO_SIDED||||||Mixed Models Analysis|||Baseline to Followup||||0.0053
71026081|NCT02833415|141559247|OTHER|Differences of Least Squares Means|Differences of Least Squares Means|0.152|STANDARD_ERROR_OF_MEAN|0.2424||0.5394|TWO_SIDED||||||Mixed Models Analysis|||Baseline to Followup||||0.5394
71026082|NCT01769378|141559248|SUPERIORITY_OR_OTHER||LS Squares Mean Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-1.57|-0.97|||Mixed Models Analysis|||||-0.97|-1.57|<0.001
71026083|NCT01769378|141559249|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.37|||<|0.001|TWO_SIDED|95.0|3.82|33.84|||Regression, Logistic|Sequential gatekeeping strategy was used to adjust for multiplicity.||\<7.0% HbA1c||33.84|3.82|<0.001
71026084|NCT01769378|141559249|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.45|||<|0.001|TWO_SIDED|95.0|3.71|35.34|||Regression, Logistic|||≤6.5% HbA1c||35.34|3.71|<0.001
71026085|NCT01769378|141559250|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-33.54|STANDARD_ERROR_OF_MEAN|6.6|<|0.001|TWO_SIDED|95.0|-46.55|-20.53|||ANCOVA|Sequential gatekeeping strategy was used to adjust for multiplicity.||||-20.53|-46.55|<0.001
71109129|NCT03181971|141723888|SUPERIORITY||Adjusted mean difference|0.04||||0.46|TWO_SIDED|95.0|-0.06|0.1|||Mixed Models Analysis|||Analysis of between group change from baseline to 7 months.||0.1|-0.06|.46
71109130|NCT03181971|141723888|SUPERIORITY||Adjusted mean difference|-0.02||||0.8|TWO_SIDED|95.0|-0.2|0.1|||Mixed Models Analysis|||Analysis of between group change from baseline to 15 months.||0.1|-0.2|.80
70852148|NCT00130247|141192731|NON_INFERIORITY_OR_EQUIVALENCE|This two-sided equivalence trial compared the efficacy of 4 and 6 months of treatment. We assumed that the risk of relapse for patients in the 6 month arm was 3.5% and that an absolute difference of 5% (i.e. relapse rate of 8.5%) was clinically meaningful. For a level of significance of 0.05 and 80% power (two sided), we estimated that 284 evaluable subjects per arm were required.|Risk Difference (RD)|0.054||||||95.0|0.01|0.1|||Regression, Cox||Confidence interval for difference of binomial proportions adjusted with Hauck Anderson continuity correction.|||0.10|0.01|
71109131|NCT03181971|141723889|SUPERIORITY||Adjusted mean difference|0.001||||0.93|TWO_SIDED|95.0|-0.03|0.03|||Mixed Models Analysis|||Analysis of between group change from baseline to 7 months.||0.03|-0.03|.93
70852149|NCT01904773|141192737|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.42|STANDARD_ERROR_OF_MEAN|0.9||0.0087||||||Bonferroni-Holm adjustment, compared with 0.025|ANCOVA|Each subject received each treatment multiple times in a crossover design||Comparison with placebo||||0.0087
71109132|NCT03181971|141723889|SUPERIORITY||Adjusted mean difference|-0.02||||0.36|TWO_SIDED|95.0|-0.06|0.02|||Mixed Models Analysis|||Analysis of between group change from baseline to 15 months.||0.02|-0.06|.36
70935363|NCT04679675|141371700|SUPERIORITY||Risk Ratio (RR)|1.9||||0.05|TWO_SIDED|95.0|1.68|2.16|||Poisson Regression with GEE|||Primary analysis stratified by screening history. These results are for Screening-Overdue (population):Direct-Mail versus Education analysis.||2.16|1.68|.05
70935364|NCT04679675|141371700|SUPERIORITY||Risk Ratio (RR)|1.14||||0.05|TWO_SIDED|95.0|1.03|1.25|||Poisson Regression with GEE|||Primary analysis stratified by screening history. These results are for Screening-Unknown (population):Opt-In versus Education analysis.||1.25|1.03|.05
71026086|NCT01769378|141559251|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.43||0.12|TWO_SIDED|95.0|-1.53|0.18|||Mixed Models Analysis|Sequential gatekeeping strategy was used to adjust for multiplicity.||||0.18|-1.53|0.120
71109133|NCT03181971|141723890|SUPERIORITY||Percent difference in change|1.4||||0.7|TWO_SIDED|95.0|-5.3|8.5||Because of skewed distributions, dietary outcomes were log-transformed and regression coefficients were exponentiated to derive the percent change in outcomes by intervention status over time.|Mixed Models Analysis|||Analysis of between group change in total kcal intake from baseline to 7 months.||8.5|-5.3|0.70
71026087|NCT01769378|141559252|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.16||0.161|TWO_SIDED|95.0|-0.54|0.09||No adjustment for multiplicity|Mixed Models Analysis|||||0.09|-0.54|0.161
70935365|NCT02234141|141371708|OTHER|Nonparametric pairwise comparison|||||=|0.214||||||P-value was calculated using the generalized van Elteren test/van Elteren test (gvE/vE; stratified Wilcoxon rank sum test).|gvE/vE|||The protocol-specified primary analysis was to compare each selonsertib dose group with the placebo group, using Wilcoxon (van Elteren) test, with respect to change from baseline in PVR at Week 24, stratifying by randomization stratum (the underlying etiology of PAH idiopathic/heritable \[yes/no\] and the number of background PAH therapies they were receiving {1, 2, or greater than or equal to \[≥\] 3}).||||= 0.214
71026088|NCT01769378|141559253|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-28.95|STANDARD_ERROR_OF_MEAN|4.85|<|0.001|TWO_SIDED|95.0|-38.49|-19.4|||Mixed Models Analysis|||||-19.40|-38.49|<0.001
71026089|NCT02324972|141559264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.636|TWO_SIDED|95.0|-1.3|1.25|||ANCOVA|||A sample size of 20 subjects per group was assumed to have 80% power to allow detection of a statistically significant difference in change from baseline in TLSS between the 2 groups, if the effect size was approximately less than or equal to 0.9. This is equivalent to detecting a difference of -4.5 between the 2 groups with a common standard deviation of 5. The primary analysis was doing using last observation carried forward (LOCF) imputed data.||1.25|-1.30|0.636
71026090|NCT02324972|141559265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.677|TWO_SIDED|95.0|-0.44|0.68|||ANOVA|||||0.68|-0.44|0.677
71026091|NCT02324972|141559266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.219||||0.802|TWO_SIDED|95.0|-1.983|1.544|||ANOVA|||||1.544|-1.983|0.802
70852150|NCT01904773|141192737|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.34|STANDARD_ERROR_OF_MEAN|0.85||0.1198||||||Bonferroni-Holm compared with 0.025|ANCOVA|Each subject received each treatment multiple times in a crossover design||||||0.1198
70852151|NCT00606905|141192747|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37|||<|0.05|TWO_SIDED|95.0|0.41|4.61|||Chi-squared|||||4.61|0.41|<0.05
70852152|NCT03255629|141192762|OTHER|||||||0.103|||||||McNemar|||||||0.103
70852153|NCT03255629|141192763|OTHER|||||||0.18|||||||McNemar|||||||0.180
70852154|NCT03255629|141192765|OTHER|||||||0.317|||||||McNemar|||||||0.317
70852155|NCT03255629|141192766|OTHER|||||||0.008|||||||McNemar|||||||0.008
70852156|NCT03255629|141192767|OTHER|||||||0.083|||||||McNemar|||||||0.083
70852157|NCT03255629|141192768|OTHER|||||||0.025|||||||McNemar|||||||0.025
70852158|NCT03255629|141192770|OTHER|||||||0.049|||||||Mixed Models Analysis|Linear mixed effects models to account for correlation within subjects over time||||||0.049
70852159|NCT03255629|141192771|OTHER|||||||0.056|||||||Mixed Models Analysis|Linear mixed effects models to account for correlation within subjects over time||||||0.056
70852160|NCT03255629|141192772|OTHER|||||||0.004|||||||Mixed Models Analysis|||||||0.004
70941714|NCT04748445|141383935|OTHER||Slope|2.78|STANDARD_ERROR_OF_MEAN|9.751||0.0051|TWO_SIDED|90.0|1.164|4.396|||Mixed Models Analysis|||EE\_MFCC 1st order delta 04 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and estimated value it was 10\^-3. For dispersion value it was 10\^-4).||4.396|1.164|0.0051
71026092|NCT02324972|141559267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108||||0.976|TWO_SIDED|95.0|-7.076|7.292|||ANOVA|||||7.292|-7.076|0.976
70852161|NCT03255629|141192773|OTHER|||||||0.059|||||||Mixed Models Analysis|||||||0.059
70852162|NCT03255629|141192774|OTHER|||||||0.195|||||||Mixed Models Analysis|||||||0.195
71026093|NCT02324972|141559268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.52||||0.233|TWO_SIDED|95.0|-1.68|6.72|||ANOVA|||||6.72|-1.68|0.233
71026094|NCT00220701|141559360|SUPERIORITY_OR_OTHER||F statistics|2.82||||0.1|TWO_SIDED||||||Repeated Measures ANOVA|||||||0.10
71026095|NCT00755326|141559366|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
70852163|NCT03255629|141192775|OTHER|||||||0.043|||||||Mixed Models Analysis|||||||0.043
70852164|NCT03255629|141192776|OTHER|||||||0.659|||||||Mixed Models Analysis|||||||0.659
70852165|NCT03255629|141192777|OTHER|||||||0.406|||||||Mixed Models Analysis|||||||0.406
70852166|NCT03255629|141192778|OTHER|||||||0.611|||||||Mixed Models Analysis|||||||0.611
70852167|NCT03255629|141192779|OTHER|||||||0.183|||||||Mixed Models Analysis|||||||0.183
70852168|NCT03255629|141192780|OTHER|||||||0.009|||||||Mixed Models Analysis|||||||0.009
70852169|NCT03255629|141192781|OTHER|||||||0.789|||||||Mixed Models Analysis|||||||0.789
70852170|NCT03255629|141192782|OTHER|||||||0.865|||||||McNemar|||||||0.865
70852171|NCT03255629|141192783|OTHER|||||||0.875|||||||McNemar|||||||0.875
70852172|NCT01767142|141192803|OTHER||sucess proportion|83.9|||||TWO_SIDED|95.0|74.8|90.7||||||||90.7|74.8|
70852173|NCT04075734|141192820|SUPERIORITY|||||||0.59|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.59
70852174|NCT04075734|141192820|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|A linear mixed model for repeat measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.003
70852175|NCT04075734|141192821|SUPERIORITY|||||||0.03|TWO_SIDED|95.0|||||Mixed Models Analysis|A linear mixed model for repeat measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.03
70852176|NCT04075734|141192822|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|A linear mixed model for repeat measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.07
70852177|NCT04075734|141192823|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|A linear mixed model for repeat measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.2
70852178|NCT04075734|141192824|SUPERIORITY|||||||0.006|||||||Mixed Models Analysis|A linear mixed model for repeat measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.006
70852179|NCT04075734|141192825|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.86
71058767|NCT04807400|141624082|SUPERIORITY||Least Squares Mean|-31.8|STANDARD_ERROR_OF_MEAN|3.1|<|0.001|TWO_SIDED|95.0|-37.91|-25.77||p-values are adjusted using Holm's procedure.|ANCOVA|||||-25.77|-37.91|<0.001
70935366|NCT02234141|141371708|OTHER|Nonparametric pairwise comparison|||||=|0.27||||||P-value was calculated using the generalized van Elteren test/van Elteren test (gvE/vE; stratified Wilcoxon rank sum test).|gvE/vE|||The protocol-specified primary analysis was to compare each selonsertib dose group with the placebo group, using Wilcoxon (van Elteren) test, with respect to change from baseline in PVR at Week 24, stratifying by randomization stratum (the underlying etiology of PAH idiopathic/heritable \[yes/no\] and the number of background PAH therapies they were receiving \[1, 2, or ≥ 3\]).||||= 0.270
70935367|NCT02234141|141371708|OTHER|Nonparametric pairwise comparison|||||=|0.604||||||P-value was calculated using the generalized van Elteren test/van Elteren test (gvE/vE; stratified Wilcoxon rank sum test)|gvE/vE|||The protocol-specified primary analysis was to compare each selonsertib dose group with the placebo group, using Wilcoxon (van Elteren) test, with respect to change from baseline in PVR at Week 24, stratifying by randomization stratum (the underlying etiology of PAH idiopathic/heritable \[yes/no\] and the number of background PAH therapies they were receiving \[1, 2, or ≥ 3\]).||||= 0.604
71026096|NCT04041570|141559379|OTHER|t-tests were only employed to determine which individuals were responders. Response rates with 95% Clopper-Pearson confidence intervals were reported within group.||||||0.05||||||The p-value was not adjusted for multiple comparisons and was only used to assess whether participants had a positive response or not.|t-test, 1 sided|This test was only used to determine whether participants were positive responders or not.||Statistical testing was performed within group and not between groups. Positivity for an individual was determined if there was a significant (p-value\<0.05) increase (one-sided test) in the ELISA titers at week 4 when compared to those at baseline. For each participant a t-test was performed to compare the triplicate baseline titers to their triplicate week 4 titers. The proportion of positive responses and associated Clopper-Pearson 95% was calculated within group.|For each participant, a positive response was defined as a significant increase in ELISA titer post vaccination (Week 4) from baseline (Week 0). Within each participant, a t-test is performed to compare the triplicate readings (replicates 1-3) post vaccination versus the triplicate readings at baseline. A participant is defined as a positive responder if one-sided t-test has p-value \< 0.05. The proportion of responders and associated 95% Clopper-Pearson Confidence Intervals were calculated.|||0.05
71026097|NCT01111110|141559385|SUPERIORITY_OR_OTHER_LEGACY||half the mean difference|21.0|STANDARD_ERROR_OF_MEAN|6.7||0.026|TWO_SIDED|95.0|3.8|41.7|||t-test, 2 sided|two sample effect size must be halved to account for mean difference estimates twice the effect size|See 4 Puff result|(Comparison of period 2 minus period 1) results Point and interval estimates are halved because this estimates twice the effect size.||41.7|3.8|0.026
71109134|NCT03181971|141723890|SUPERIORITY||Percent difference in change|3.7||||0.35|TWO_SIDED|95.0|-3.9|12.0||Because of skewed distributions, dietary outcomes were log-transformed and regression coefficients were exponentiated to derive the percent change in outcomes by intervention status over time.|Mixed Models Analysis|||Analysis of between group change in intake of food kcal from baseline to 7 months.||12.0|-3.9|.35
71109135|NCT03181971|141723890|SUPERIORITY||Percent difference in change|-10.6||||0.35|TWO_SIDED|95.0|-29.2|8.8|||Mixed Models Analysis|||Analysis of between group change in intake of beverage kcal from baseline to 7 months.||8.8|-29.2|.35
71026098|NCT01111110|141559386|SUPERIORITY_OR_OTHER_LEGACY||half the mean difference|23.5|STANDARD_ERROR_OF_MEAN|6.8||0.018|TWO_SIDED|95.0|6.0|41.0||The effect size is half the difference between the means as (A-B)-(B-A)=2A-2B|t-test, 2 sided|Must take half the mean difference to estimate effect size|No comments|Study intended to get more subjects, but PI's review committee had to deal with candidate deadlines and a high rate of screen failures and allowed her to test seven subjects. Primary concern was the research experience, not the study questions. There was no bias in failing to meet accrual objectives thanks to the blinding.||41.0|6.0|0.018
71026099|NCT01111110|141559387|SUPERIORITY_OR_OTHER_LEGACY||Effect size=half the mean diff|24.7|STANDARD_ERROR_OF_MEAN|6.6||0.013|TWO_SIDED|95.0|7.7|41.7|||t-test, 2 sided||You kicked this out on another trial, but note that the period 2-Period 1 differences between the orderings estimate twice the effect size. The effect sizes herein take this into account.|Null hypothesis is that the Treatment order is independent of the dependent variable based on Period 2 minus Period 1||41.7|7.7|0.013
71026100|NCT00384033|141559388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.198|TWO_SIDED|95.0|-0.6|2.7||The analysis was done at a significance level of alpha = 0.05, 2-sided. Global F-test was used to adjust for multiplicity. If global F-test was significant at 0.05 level, pair wise analysis was interpreted without any further p-value adjustment.|ANCOVA|||For DVS SR 50 mg, HAM-D17 total score was evaluated using analysis of covariance (ANCOVA) with treatment and site as factors and baseline HAM-D17 score as the covariate.||2.70|-0.60|0.198
71026101|NCT00384033|141559388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.028|TWO_SIDED|95.0|0.2|3.4||The analysis was done at a significance level of alpha = 0.05, 2-sided. Global F-test was used to adjust for multiplicity. If global F-test was significant at 0.05 level, pair wise analysis was interpreted without any further p-value adjustment.|ANCOVA|||For DVS SR 100 mg, HAM-D17 total score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D17 score as the covariate.||3.40|0.20|0.028
71109136|NCT03181971|141723890|SUPERIORITY||Percent difference in change|-17.5||||0.18|TWO_SIDED|95.0|-37.8|9.6|||Mixed Models Analysis|||Analysis of between group change in SSB kcal from baseline to 7 months.||9.6|-37.8|.18
71109137|NCT03181971|141723891|SUPERIORITY||Percent difference in change|9.1||||0.59|TWO_SIDED|95.0|-20.6|49.9||Because of skewed distributions, dietary outcomes were log-transformed and regression coefficients were exponentiated to derive the percent change in outcomes by intervention status over time.|Mixed Models Analysis|||Analysis of between group change from baseline to 7 months.||49.9|-20.6|.59
71109138|NCT03181971|141723892|SUPERIORITY||Percent difference in change|23.2|||<|0.001|TWO_SIDED|95.0|13.1|34.2|||Mixed Models Analysis|||Analysis of between group change in water intake from baseline to 7 months.||34.2|13.1|<.001
71109139|NCT03181971|141723892|SUPERIORITY||Percent difference in change|14.7||||0.004|TWO_SIDED|95.0|4.5|25.9|||Mixed Models Analysis|||Analysis of between group change in water intake from baseline to 15 months.||25.9|4.5|.004
71109140|NCT03181971|141723892|SUPERIORITY||Percent difference in change|-8.0||||0.063|TWO_SIDED|95.0|-15.7|0.4|||Mixed Models Analysis|||Analysis of between group change in SSB intake from baseline to 7 months.||0.4|-15.7|0.063
70935368|NCT00186446|141371747|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|t(19)= -8.93||||||<.001
70935369|NCT04604652|141371757|OTHER||||||=|0.077|||||||t-test, 1 sided|||A t-test was performed to test for the percent change from baseline to Week 12. This analysis was based on observed data without imputation. Testing was one sided using a 5% alpha level. No multiplicity adjustment was used, and the p-values reported for the endpoints were descriptive in nature.||||=0.077
71058768|NCT04807400|141624082|SUPERIORITY||Least Squares Mean|-32.1|STANDARD_ERROR_OF_MEAN|3.17|<|0.001|TWO_SIDED|95.0|-38.35|-25.94||p-values are adjusted using Holm's procedure.|ANCOVA|||||-25.94|-38.35|<0.001
71058769|NCT04807400|141624084|SUPERIORITY||Least-squares Mean|1.4|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|0.62|2.13|||ANOVA|||||2.13|0.62|<0.001
71058770|NCT04807400|141624084|SUPERIORITY||Least-squares Mean|1.3|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|0.6|2.1|||ANOVA|||||2.10|0.60|<0.001
71058771|NCT04807400|141624085|SUPERIORITY||Least-squares Mean|-0.03|STANDARD_ERROR_OF_MEAN|0.326||0.9347|TWO_SIDED|95.0|-0.67|0.61|||ANOVA|||||0.61|-0.67|0.9347
71058772|NCT04807400|141624086|SUPERIORITY||Least-squares Mean|1.0|STANDARD_ERROR_OF_MEAN|2.34||0.6759|TWO_SIDED|95.0|-3.62|5.58|||ANCOVA|||||5.58|-3.62|0.6759
71058773|NCT04807400|141624086|SUPERIORITY||Least-squares Mean|1.3|STANDARD_ERROR_OF_MEAN|2.31||0.5756|TWO_SIDED|95.0|-3.25|5.84|||ANCOVA|||||5.84|-3.25|0.5756
71058774|NCT04807400|141624087|SUPERIORITY||Least-squares Mean|0.3|STANDARD_ERROR_OF_MEAN|1.69||0.858|TWO_SIDED|95.0|-3.02|3.62|||ANCOVA|||||3.62|-3.02|0.8580
71058775|NCT03656744|141624089|SUPERIORITY|||||||0.199|||||||ANCOVA|||||||0.199
71058776|NCT03656744|141624089|SUPERIORITY|||||||0.011|||||||ANCOVA|||||||0.011
71109141|NCT03181971|141723892|SUPERIORITY||Percent difference in change|-2.8||||0.56|TWO_SIDED|95.0|-11.7|6.9|||Mixed Models Analysis|||Analysis of between group change in SSB intake from baseline to 15 months.||6.9|-11.7|.56
71109142|NCT03181971|141723892|SUPERIORITY||Percent difference in change|1.2||||0.68|TWO_SIDED|95.0|-4.3|7.0|||Mixed Models Analysis|||Analysis of between group change in juice intake from baseline to 7 months.||7|-4.3|.68
71109143|NCT03181971|141723892|SUPERIORITY||Percent difference in change|-1.4||||0.66|TWO_SIDED|95.0|-7.4|5.0|||Mixed Models Analysis|||Analysis of between group change in juice intake from baseline to 15 months.||5|-7.4|.66
71109144|NCT03181971|141723892|SUPERIORITY||Percent difference in change|-4.0||||0.079|TWO_SIDED|95.0|-8.3|0.5|||Mixed Models Analysis|||Analysis of between group change in flavored milk intake from baseline to 7 months.||0.5|-8.3|0.079
71109145|NCT03181971|141723892|SUPERIORITY||Percent difference in change|-3.0||||0.26|TWO_SIDED|95.0|-8.0|2.3|||Mixed Models Analysis|||Analysis of between group change in flavored milk intake from baseline to 15 months.||2.3|-8.0|.26
71109146|NCT03181971|141723892|SUPERIORITY||Percent difference in change|4.4||||0.2|TWO_SIDED|95.0|-2.2|11.5|||Mixed Models Analysis|||Analysis of between group change in plain milk intake from baseline to 7 months.||11.5|-2.2|.20
71109147|NCT03181971|141723892|SUPERIORITY||Percent difference in change|2.3||||0.51|TWO_SIDED|95.0|-4.4|9.6|||Mixed Models Analysis|||Analysis of between group change in plain milk intake from baseline to 15 months.||9.6|-4.4|.51
71109148|NCT03181971|141723893|SUPERIORITY||Percent difference in change|31.3|||<|0.001|TWO_SIDED|95.0|21.2|42.2|||Mixed Models Analysis|||Analysis of between group change in water intake from water source at lunch from baseline to 7 months.||42.2|21.2|<.001
70852180|NCT04075734|141192826|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.14
71109149|NCT03181971|141723893|SUPERIORITY||Percent difference in change|4.9||||0.22|TWO_SIDED|95.0|-3.0|13.5|||Mixed Models Analysis|||Analysis of between group change in water intake from water source during lunch from baseline to 15 months.||13.5|-3.0|.22
71109150|NCT03181971|141723893|SUPERIORITY||Percent difference in change|17.0||||0.02|TWO_SIDED|95.0|2.6|33.3|||Mixed Models Analysis|||Analysis of between group change in water intake from water source at recess from baseline to 7 months.||33.3|2.6|.02
71109151|NCT03181971|141723893|SUPERIORITY||Percent difference in change|4.7||||0.48|TWO_SIDED|95.0|-8.0|19.2|||Mixed Models Analysis|||Analysis of between group change in water intake from water source at recess from baseline to 15 months.||19.2|-8.0|.48
71058777|NCT03656744|141624090|SUPERIORITY|||||||0.152|||||||ANCOVA|||||||0.152
71058778|NCT03656744|141624090|SUPERIORITY|||||||0.109|||||||ANCOVA|||||||0.109
71058779|NCT03656744|141624091|SUPERIORITY|||||||0.034|||||||ANCOVA|||||||0.034
71058780|NCT03656744|141624091|SUPERIORITY|||||||0.004|||||||ANCOVA|||||||0.004
71058781|NCT03656744|141624092|SUPERIORITY|||||||0.884|||||||Regression, Logistic|||||||0.884
71058782|NCT03656744|141624092|SUPERIORITY|||||||0.236|||||||Regression, Logistic|||||||0.236
71058783|NCT03656744|141624093|SUPERIORITY|||||||0.196|||||||ANCOVA|||||||0.196
71058784|NCT03656744|141624093|SUPERIORITY|||||||0.016|||||||ANCOVA|||||||0.016
71058785|NCT03656744|141624094|SUPERIORITY|||||||0.294|||||||Cochran-Mantel-Haenszel|||||||0.294
71058786|NCT03656744|141624095|SUPERIORITY|||||||0.287|||||||Regression, Logistic|||||||0.287
71058787|NCT03656744|141624095|SUPERIORITY|||||||0.09|||||||Regression, Logistic|||||||0.090
71058788|NCT03656744|141624096|SUPERIORITY|||||||0.201|||||||ANCOVA|||||||0.201
71058789|NCT03656744|141624096|SUPERIORITY|||||||0.534|||||||ANCOVA|||||||0.534
71058790|NCT03656744|141624097|SUPERIORITY|||||||0.955|||||||ANCOVA|||||||0.955
71058791|NCT03656744|141624097|SUPERIORITY|||||||0.072|||||||ANCOVA|||||||0.072
71058792|NCT03656744|141624098|SUPERIORITY|||||||0.041|||||||ANCOVA|||||||0.041
71058793|NCT03656744|141624098|SUPERIORITY|||||||0.12|||||||ANCOVA|||||||0.120
71058794|NCT03656744|141624099|SUPERIORITY|||||||0.955|||||||ANCOVA|||||||0.955
71058795|NCT03656744|141624099|SUPERIORITY|||||||0.072|||||||ANCOVA|||||||0.072
71058796|NCT03656744|141624100|SUPERIORITY|||||||0.488|||||||ANCOVA|||||||0.488
71058797|NCT03656744|141624100|SUPERIORITY|||||||0.022|||||||ANCOVA|||||||0.022
71058798|NCT03656744|141624101|SUPERIORITY|||||||0.674|||||||ANCOVA|||||||0.674
71058799|NCT03656744|141624101|SUPERIORITY|||||||0.03|||||||ANCOVA|||||||0.030
71058800|NCT03656744|141624102|SUPERIORITY|||||||0.588|||||||Regression, Logistic|||||||0.588
71058801|NCT03656744|141624102|SUPERIORITY|||||||0.103|||||||Regression, Logistic|||||||0.103
71058802|NCT03656744|141624103|SUPERIORITY|||||||0.236|||||||ANCOVA|||||||0.236
70935370|NCT02833948|141371778|SUPERIORITY|||||||0.01|||||||Fisher Exact|The Fisher's exact probability test was used to compare the percentages of patients with the primary end point between the treatment groups.||||||0.01
71026102|NCT00384033|141559388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.047|TWO_SIDED|95.0|0.0|3.4||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, HAM-D17 total score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D17 score as the covariate.||3.40|0.00|0.047
71026103|NCT00384033|141559389|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED|||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||For DVS SR 50 mg, CGI-I was evaluated using Cochran-Mantel-Haenszel (CMH) test with treatment as a factor and controlling for center.||||0.110
71026104|NCT00384033|141559389|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED|||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||For DVS SR 100 mg, CGI-I was evaluated using CMH test with treatment as a factor and controlling for center.||||0.009
71058803|NCT03656744|141624103|SUPERIORITY|||||||0.944|||||||ANCOVA|||||||0.944
71058804|NCT03656744|141624104|SUPERIORITY|||||||0.267|||||||ANCOVA|||||||0.267
71058805|NCT03656744|141624104|SUPERIORITY|||||||0.911|||||||ANCOVA|||||||0.911
71058806|NCT03656744|141624105|SUPERIORITY|||||||0.387|||||||ANCOVA|||||||0.387
71058807|NCT03656744|141624105|SUPERIORITY|||||||0.855|||||||ANCOVA|||||||0.855
71058808|NCT03656744|141624106|SUPERIORITY|||||||0.107|||||||ANCOVA|||||||0.107
71058809|NCT03656744|141624106|SUPERIORITY|||||||0.489|||||||ANCOVA|||||||0.489
71109152|NCT03181971|141723893|SUPERIORITY||Percent difference in change|34.6||||0.14|TWO_SIDED|95.0|-9.4|99.8|||Mixed Models Analysis|||Analysis of between group change in water intake from water source at PE from baseline to 7 months.||99.8|-9.4|.14
70935371|NCT02833948|141371782|SUPERIORITY|||||||0.01|||||||Fisher Exact|||||||0.01
70935372|NCT03182244|141371793|SUPERIORITY||Hazard Ratio (HR)|0.612||||0.00152|TWO_SIDED|95.0|0.451|0.832|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per interactive response technology (IRT).|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||0.832|0.451|0.00152
70935373|NCT03182244|141371794|SUPERIORITY||Hazard Ratio (HR)|0.589||||5e-05|TWO_SIDED|95.0|0.438|0.792|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||0.792|0.438|0.00005
71026105|NCT00384033|141559389|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||For Duloxetine 60 mg, CGI-I was evaluated using CMH test with treatment as a factor and controlling for center.||||0.008
71058810|NCT03656744|141624107|SUPERIORITY|||||||0.515|||||||ANCOVA|||||||0.515
71058811|NCT03656744|141624107|SUPERIORITY|||||||0.887|||||||ANCOVA|||||||0.887
71058812|NCT03656744|141624108|SUPERIORITY|||||||0.003|||||||ANCOVA|||||||0.003
71058813|NCT03656744|141624108|SUPERIORITY|||||||0.016|||||||ANCOVA|||||||0.016
71058814|NCT03656744|141624109|SUPERIORITY|||||||0.124|||||||ANCOVA|||||||0.124
71058815|NCT03656744|141624109|SUPERIORITY|||||||0.171|||||||ANCOVA|||||||0.171
71058816|NCT03076775|141624113|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
71058817|NCT03076775|141624114|SUPERIORITY|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
71058818|NCT03076775|141624115|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
71058819|NCT03076775|141624116|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
71058820|NCT03076775|141624117|SUPERIORITY|||||||0.83|||||||Chi-squared|||||||0.83
71058821|NCT03076775|141624118|SUPERIORITY|||||||0.79|||||||Chi-squared|||||||0.79
71058822|NCT03076775|141624119|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
71058823|NCT03076775|141624120|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||||||0.44
71058824|NCT03076775|141624121|SUPERIORITY|||||||0.16|||||||Chi-squared|||||||0.16
71058825|NCT03076775|141624122|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||||||0.59
71058826|NCT03295630|141624163|OTHER||Mean Difference (Final Values)|-17.7|||||TWO_SIDED|||||||||Difference (steps) between accelerometer quantified step count (thigh placement) and observed step count||||
71058827|NCT03295630|141624163|OTHER||Intraclass Correlation Coefficient|0.46|||||TWO_SIDED|95.0|-0.1|0.78||||||Correlation between accelerometer quantified step count (thigh placement) and observed step count||0.78|-0.1|
71058828|NCT03295630|141624163|OTHER||Mean Difference (Final Values)|-0.84|||||TWO_SIDED|||||||||Difference (steps) between accelerometer quantified steps (ankle placement) and observed step count||||
71058829|NCT03295630|141624163|OTHER||Intraclass Correlation Coefficient|0.99|||||TWO_SIDED|95.0|0.99|1.0||||||Correlation between accelerometer quantified steps (ankle placement) and observed steps||1.0|0.99|
71077954|NCT02913105|141664400|SUPERIORITY|Change from baseline was analyzed using an ANCOVA model which included effects for treatment, baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|4.93||0.9645|TWO_SIDED|90.0|-7.974|8.414|||ANCOVA|||||8.414|-7.974|0.9645
71077955|NCT01153009|141664424|SUPERIORITY_OR_OTHER||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|1.21||0.224|TWO_SIDED|95.0|-3.86|0.91||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops for this dose and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||All statistical tests were 2-sided with the estimated P-values at the 5% level of significance. To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 15 mg and 20 mg vortioxetine to placebo. Efficacy endpoints were tested for each dose in a sequential order at significance level 0.025; as soon as an endpoint was non-significant at 0.025, the testing procedure stopped for all subsequent endpoints.||0.91|-3.86|0.224
71058830|NCT03541317|141624196|SUPERIORITY|A test of the null hypothesis that there is no difference between these two strategies on the sum of the average number of CBT sessions delivered to students by SPs over the four post-randomization phases during Stages 1 and 2|Difference in sum of means*|9.7||||0.63|TWO_SIDED|95.0|-30.03|49.4|||weighted least squares regression|Marginal means under each implementation strategy estimated after each of 4 post-randomization phases (NeCamp, Kilbourne, \& Almirall 2017)|\*Difference in the sum of the means estimated at each post-randomization phase.|||49.40|-30.03|0.63
71058831|NCT03541317|141624197|SUPERIORITY|A test of the null hypothesis that there is no difference between these two strategies on the sum of the average number of brief individual CBT sessions (\<15 min.) delivered to students by SPs over the four post-randomization phases occurring during Stages 1 and 2.|Difference in sum of means*|3.78||||0.72|TWO_SIDED|95.0|-16.88|24.44|||weighted least squares regression|Marginal means under each embedded implementation strategy estimated after each of 4 post-randomization phases (NeCamp, Kilbourne \& Almirall 2017)|\*Difference in the sum of the means estimated at each post-randomization phase|||24.44|-16.88|0.72
71058832|NCT03541317|141624198|SUPERIORITY|A test of the null hypothesis that there is no difference between these two strategies on the sum of the average number of brief individual CBT sessions (\>15 min.) delivered to students by SPs over the four post-randomization phases occurring during Stages 1 and 2.|Difference in sum of means*|7.85||||0.46|TWO_SIDED|95.0|-13.2|28.91|||Weighted Least Squares Regression|Marginal means under each embedded implementation strategy estimated after each of 4 post-randomization phases (NeCamp, Kilbourne \& Almirall 2017).|Difference in the sum of the means estimated at each post-randomization phase|||28.91|-13.20|0.46
71058833|NCT03541317|141624199|SUPERIORITY||Difference in sum of means*|-0.66||||0.87|TWO_SIDED|95.0|-8.49|7.16|||Weighted Least Squares Regression|Marginal means under each embedded implementation strategy estimated after each of 4 post-randomization phases (NeCamp, Kilbourne \& Almirall 2017).|Difference in the sum of the means estimated at each post-randomization phase|A test of the null hypothesis that there is no difference between these two strategies on the sum of the average number of group CBT sessions delivered to students by SPs over the four post-randomization phase occurring during Stages 1 and 2.||7.16|-8.49|0.87
71058834|NCT03048552|141624254|SUPERIORITY|||||||0.148|||||||Fisher Exact|||||||0.148
71058835|NCT03048552|141624255|SUPERIORITY||||||<|0.01|||||||Fisher Exact|||||||<0.01
71058836|NCT03048552|141624256|SUPERIORITY|||||||0.818|||||||Fisher Exact|||||||0.818
71058837|NCT03048552|141624258|SUPERIORITY|||||||0.625|||||||Fisher Exact|||||||0.625
71058838|NCT02487225|141624271|SUPERIORITY|||||||0.5796|||||||Kruskal-Wallis|||Admission (baseline)||||0.5796
71058839|NCT02487225|141624271|SUPERIORITY|||||||0.8415|||||||Kruskal-Wallis|||Day 5||||0.8415
71058840|NCT02487225|141624272|SUPERIORITY|||||||0.1109|||||||Kruskal-Wallis|||Admission (baseline)||||0.1109
71058841|NCT02487225|141624272|SUPERIORITY|||||||0.4619|||||||Kruskal-Wallis|||||||0.4619
71058842|NCT02487225|141624273|SUPERIORITY|||||||0.1236|||||||Kruskal-Wallis|||Admission (baseline)||||0.1236
71058843|NCT02487225|141624273|SUPERIORITY|||||||0.9468|||||||Kruskal-Wallis|||Day 5||||0.9468
71058844|NCT02487225|141624274|SUPERIORITY|||||||0.157|||||||Kruskal-Wallis|||Admission (baseline)||||0.157
71058845|NCT02487225|141624274|SUPERIORITY|||||||0.3173|||||||Kruskal-Wallis|||Day 5||||0.3173
71058846|NCT04208750|141624275|OTHER|Difference between independent proportions||||||||||||||||Added the number of participants from each study arm who preferred each refraction type and then converted it to the proportions|For each outcome, we compared the proportion of participants from both study arms who preferred the VR800 refraction to the proportion of participants who preferred the Standard refraction using a 2-sample test for equality of proportions.|||
71058847|NCT00247676|141624333|SUPERIORITY_OR_OTHER||clinical benefit response rate|37.8||||||95.0|22.5|55.2|||||Clinical benefit response rate: percent of patients with confirmed CR, confirmed PR, or SD for at least 12 weeks according to RECIST, relative to total treated patients.|||55.2|22.5|
71058848|NCT00247676|141624338|SUPERIORITY_OR_OTHER||objective response rate|2.7||||||95.0|0.1|14.2|||||percentage of patients with confirmed CR or confirmed PR according to RECIST, relative to the total number of treated patients.|||14.2|0.1|
71058849|NCT00247676|141624342|SUPERIORITY_OR_OTHER||probability|0.324||||||95.0|0.168|0.479|||||probability derived from Kaplan-Meier estimate.|||0.479|0.168|
71058850|NCT01750190|141624389|SUPERIORITY||Least Square Mean Difference|1.85|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|95.0|1.735|1.967|||ANCOVA|MI (Multiple Imputation) ANCOVA|Roxadustat - Placebo Treatment Difference|Treatment comparison was made using the multiple imputation strategy by combining the results of analysis of covariance (ANCOVA) model with baseline Hb and baseline estimated glomerular filtration rate (eGFR) as covariates and treatment and other randomization stratification factors, except baseline Hb (≤8 g/dL versus \>8 g/dL) and eGFR (\<30 versus ≥30 milliliters \[mL\]/minutes \[min\]/1.73 meters \[m\]\^2), as fixed effects.||1.967|1.735|<0.0001
71058851|NCT01750190|141624390|SUPERIORITY||Odds Ratio (OR)|77.56|||<|0.0001|TWO_SIDED|95.0|44.73|134.48|||Cochran-Mantel-Haenszel||Roxadustat/Placebo Odds ratio|||134.48|44.73|<0.0001
71058852|NCT01750190|141624391|SUPERIORITY||Least Square Mean Difference|1.88|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|1.73|2.037|||Mixed Models Analysis|MMRM Analysis|Roxadustat - placebo treatment difference|Treatment comparison was made using MMRM with baseline Hb and baseline eGFR as covariates, and treatment, visit, visit-by-treatment interaction, and the randomization stratification factors, except baseline Hb (≤8 g/dL versus \>8 g/dL) and eGFR (\<30 versus ≥30 mL/min/1.73m\^2), as fixed effects.||2.037|1.730|<0.0001
71058853|NCT01750190|141624392|SUPERIORITY||Least Square Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|0.122|<|0.0001|TWO_SIDED|95.0|1.663|2.143|||ANCOVA|MI ANCOVA|Roxadustat - placebo treatment difference|Treatment comparison was made using the multiple imputation strategy by combining the results of ANCOVA model with baseline Hb and baseline eGFR as covariates , and treatment and other randomization stratification factors, except baseline Hb (≤8 g/dL versus \>8 g/dL) and eGFR (\<30 versus ≥30 mL/min/1.73m\^2 ), as fixed effects.||2.143|1.663|<0.0001
71058854|NCT01750190|141624393|SUPERIORITY||Odds Ratio (OR)|15.47|||<|0.0001|TWO_SIDED|95.0|10.79|22.189|||Cochran-Mantel-Haenszel||Roxadustat/placebo odds ratio|||22.189|10.79|<0.0001
71109153|NCT03181971|141723893|SUPERIORITY||Percent difference in change|32.1||||0.16|TWO_SIDED|95.0|-11.0|96.2|||Mixed Models Analysis|||Analysis of between group change in water intake from water source at PE from baseline to 15 months.||96.2|-11.0|.16
71058855|NCT01750190|141624394|SUPERIORITY||Least Square Mean Difference|-17.26|STANDARD_ERROR_OF_MEAN|1.73|<|0.0001|TWO_SIDED|95.0|-20.65|-13.87|||Mixed Models Analysis|MMRM Analysis|Roxadustat- placebo treatment difference|Treatment comparison was made using MMRM with baseline LDL cholesterol as a covariate, and treatment, visit, visit-by-treatment interaction, and the randomization stratification factors as fixed effects.||-13.87|-20.65|<0.0001
71058856|NCT01750190|141624395|SUPERIORITY||Least Square Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.528||0.6924|TWO_SIDED|95.0|-0.827|1.245|||ANCOVA|MI ANCOVA|Roxadustat - placebo treatment difference|||1.245|-0.827|0.6924
71058857|NCT01750190|141624396|SUPERIORITY||Hazard Ratio (HR)|0.26|||<|0.0001|TWO_SIDED|95.0|0.165|0.406||From a Cox Proportional hazards model adjusting for baseline Hb, baseline eGFR and other randomization stratification factors, except baseline Hb (≤8 g/dL versus \>8 g/dL) and eGFR (\<30 versus ≥30 mL/min/1.73 m\^2).|Cox Proportional hazards model|||||0.406|0.165|<0.0001
71058858|NCT01750190|141624397|SUPERIORITY||Hazard Ratio (HR)|0.17|||<|0.0001|TWO_SIDED|95.0|0.108|0.267||From a Cox Proportional hazards model adjusting for baseline Hb, baseline eGFR and the randomization stratification factors, except baseline Hb (\<=8 g/dL versus \>8 g/dL) and eGFR (\<30 versus \>=30 mL/min/1.73m\^2).|Cox Proportional hazards model|||First 24 Weeks of Treatment||0.267|0.108|<0.0001
71058859|NCT01750190|141624397|SUPERIORITY||Hazard Ratio (HR)|0.19|||<|0.0001|TWO_SIDED|95.0|0.138|0.276||From a Cox Proportional hazards model adjusting for baseline Hb, baseline eGFR and other randomization stratification factors, except baseline Hb (≤8 g/dL versus \>8 g/dL) and eGFR (\<30 versus ≥30 mL/min/1.73 m\^2).|Cox Proportional hazards model|||First 52 Weeks of Treatment||0.276|0.138|<0.0001
70852181|NCT04075734|141192827|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of intervention over time.||||||0.02
70852182|NCT04075734|141192828|SUPERIORITY|||||||0.29|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.29
70852183|NCT04075734|141192829|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.13
70935374|NCT03182244|141371795|SUPERIORITY||Treatment difference|8.9||||0.04256|TWO_SIDED|95.0|0.3|17.5|||Cochran-Mantel-Haenszel|Stratification factors: first-line AML therapy \& preselected salvage chemotherapy/IRT response. Treatment difference based on stratification factors.||||17.5|0.3|0.04256
71058860|NCT04584684|141624401|SUPERIORITY|||||||0.89||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.89
71058861|NCT04584684|141624401|SUPERIORITY|||||||0.88||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.88
71117632|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
70852184|NCT04075734|141192830|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.14
70852185|NCT04075734|141192831|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|A linear mixed model for repeat measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.03
70852186|NCT04075734|141192832|SUPERIORITY|||||||0.66|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.66
70852187|NCT04075734|141192833|SUPERIORITY|||||||0.15|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.15
70852188|NCT02250703|141192835|SUPERIORITY_OR_OTHER|||||||0.025||||||Difference in proportions in satisfactory sedation on separation from parents and on induction between M and D groups (Primary Outcome variables)|Chi-squared|||A sample size of at least 33 patients in each group would detect at least 30% difference in proportion of children who achieve satisfactory sedation between the M and D groups at 0.05 level of significance and 80% power||||0.025
70852189|NCT02250703|141192836|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
70852190|NCT02250703|141192837|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
70852191|NCT02250703|141192838|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
70935375|NCT03182244|141371796|SUPERIORITY||Hazard Ratio (HR)|1.163||||0.8871|TWO_SIDED|95.0|0.131|10.338|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||10.338|0.131|0.88710
71058862|NCT04584684|141624401|SUPERIORITY|||||||0.82||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.82
71058863|NCT04584684|141624401|SUPERIORITY|||||||0.65||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.65
71058864|NCT04584684|141624401|SUPERIORITY|||||||0.77||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.77
71058865|NCT04584684|141624401|SUPERIORITY|||||||0.76||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.76
71058866|NCT04584684|141624401|SUPERIORITY|||||||0.8||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.80
70852192|NCT01776307|141192839|OTHER|Descriptive analysis for investigational arms; no comparator analysis|||||||||||||||||The exact 95% confidence interval is based on the Clopper-Pearson method.|||
70852193|NCT01776307|141192840|OTHER|Estimates provided for investigational arms; no comparator analysis|||||||||||||||||Estimated from Kaplan Meier Curve|||
70852194|NCT01776307|141192841|OTHER|Estimates provided for investigational arms; no comparator analysis|||||||||||||||||Estimated from Kaplan Meier Curve|||
70935376|NCT03182244|141371797|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.55969|TWO_SIDED|95.0|0.209|2.414|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||2.414|0.209|0.55969
70935377|NCT03182244|141371798|SUPERIORITY||Hazard Ratio (HR)|1.583||||0.66261|TWO_SIDED|95.0|0.192|13.048|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||13.048|0.192|0.66261
70935378|NCT03182244|141371799|SUPERIORITY||Hazard Ratio (HR)|0.756||||0.55731|TWO_SIDED|95.0|0.286|1.999|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||1.999|0.286|0.55731
71026106|NCT00384033|141559390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.248|TWO_SIDED|95.0|-0.1|0.4||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, CGI-S was evaluated using ANCOVA with treatment and site as factors and baseline CGI-S score as the covariate.||0.40|-0.10|0.248
71026107|NCT00384033|141559390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.011|TWO_SIDED|95.0|0.1|0.6||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, CGI-S was evaluated using ANCOVA with treatment and site as factors and baseline CGI-S score as the covariate.||0.60|0.10|0.011
71026108|NCT00384033|141559390|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.3||||0.026|TWO_SIDED|95.0|0.0|0.6||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, CGI-S was evaluated using ANCOVA with treatment and site as factors and baseline CGI-S score as the covariate.||0.60|0.00|0.026
71026109|NCT00384033|141559391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.149|TWO_SIDED|95.0|-0.6|4.0||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, MADRS total score was evaluated using ANCOVA with treatment and site as factors and baseline MADRS score as the covariate.||4.00|-0.60|0.149
71026110|NCT00384033|141559391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3||||0.004|TWO_SIDED|95.0|1.1|5.6||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, MADRS total score was evaluated using ANCOVA with treatment and site as factors and baseline MADRS score as the covariate.||5.60|1.10|0.004
71026111|NCT00384033|141559391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4||||0.005|TWO_SIDED|95.0|1.1|5.8||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, MADRS total score was evaluated using ANCOVA with treatment and site as factors and baseline MADRS score as the covariate.||5.80|1.10|0.005
71026112|NCT00384033|141559392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.473|TWO_SIDED|95.0|-0.22|0.46||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, lassitude item of the MADRS score was evaluated using ANCOVA with treatment and site as factors and baseline lassitude item of the MADRS score as the covariate.||0.46|-0.22|0.473
71058867|NCT04584684|141624401|SUPERIORITY|||||||0.71||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.71
71058868|NCT04584684|141624401|SUPERIORITY|||||||0.6||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.60
71058869|NCT04584684|141624401|SUPERIORITY|||||||0.8||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.80
70935379|NCT03182244|141371800|SUPERIORITY||Treatment difference|17.7||||0.00049|TWO_SIDED|95.0|7.9|27.5|||Cochran-Mantel-Haenszel|Stratification factors: first-line AML therapy \& preselected salvage chemotherapy/IRT response. Treatment difference based on stratification factors.||||27.5|7.9|0.00049
70935380|NCT03182244|141371802|SUPERIORITY||Hazard Ratio (HR)|0.857||||0.56944|TWO_SIDED|95.0|0.494|1.487|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||1.487|0.494|0.56944
70935381|NCT03182244|141371803|SUPERIORITY||Treatment difference|31.2|||<|1e-05|TWO_SIDED|95.0|20.2|42.3|||Cochran-Mantel-Haenszel|Stratification factors: first-line AML therapy \& preselected salvage chemotherapy/IRT response. Treatment difference based on stratification factors.||||42.3|20.2|<0.00001
71026113|NCT00384033|141559392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.119|TWO_SIDED|95.0|-0.07|0.61||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, lassitude item of the MADRS score was evaluated using ANCOVA with treatment and site as factors and baseline lassitude item of the MADRS score as the covariate.||0.61|-0.07|0.119
71026114|NCT00384033|141559392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.71|TWO_SIDED|95.0|-0.27|0.4||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, lassitude item of the MADRS score was evaluated using ANCOVA with treatment and site as factors and baseline lassitude item of the MADRS score as the covariate.||0.40|-0.27|0.710
71058870|NCT02955212|141624416|SUPERIORITY||Response Rate Difference|40.2|||<|0.001|TWO_SIDED|95.0|30.5|50.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of country.|Response Rate Difference = Upadacitinib - Placebo|||50.0|30.5|<0.001
71058871|NCT02955212|141624417|SUPERIORITY||Least Squares (LS) Mean Difference|-1.61|||<|0.001|TWO_SIDED|95.0|-1.86|-1.36|||ANCOVA|ANCOVA model including treatment as the fixed factor, and Baseline value and the stratification factor country as the covariates.|LS Mean Difference = Upadacitinib - Placebo|||-1.36|-1.86|<0.001
70935382|NCT03182244|141371809|SUPERIORITY||Treatment difference|14.7||||0.00055|TWO_SIDED|95.0|6.5|22.8|||Cochran-Mantel-Haenszel|Stratification factors: first-line AML therapy \& preselected salvage chemotherapy/IRT response. Treatment difference based on stratification factors.||||22.8|6.5|0.00055
70935383|NCT03182244|141371810|SUPERIORITY||Least square mean difference|0.6||||0.14841||||||Analysis of covariance (ANCOVA) including treatment as a fixed factor, baseline score, response to first-line AML therapy and preselected salvage chemotherapy per IRT as covariates. LS Mean difference was estimated using chemotherapy as control.|ANCOVA|||||||0.14841
71026115|NCT00384033|141559393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.215|TWO_SIDED|95.0|-0.3|1.5||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, HAM-D6 score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D6 score as the covariate.||1.50|-0.30|0.215
71026116|NCT00384033|141559393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.005|TWO_SIDED|95.0|0.4|2.3||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, HAM-D6 score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D6 score as the covariate.||2.30|0.40|0.005
71026117|NCT00384033|141559393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.024|TWO_SIDED|95.0|0.2|2.1||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, HAM-D6 score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D6 score as the covariate.||2.10|0.20|0.024
71026118|NCT00384033|141559394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53||||0.1|TWO_SIDED|95.0|-0.1|1.17||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, HAM-D energy subscale score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D energy score as the covariate.||1.17|-0.10|0.100
71026119|NCT00384033|141559394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79||||0.014|TWO_SIDED|95.0|0.16|1.42||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, HAM-D energy subscale score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D energy score as the covariate.||1.42|0.16|0.014
71026120|NCT00384033|141559394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72||||0.032|TWO_SIDED|95.0|0.06|1.38||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, HAM-D energy subscale score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D energy score as the covariate.||1.38|0.06|0.032
71026121|NCT00384033|141559395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.445|TWO_SIDED|95.0|-0.2|0.5||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, Covi anxiety scale was evaluated using ANCOVA with treatment and site as factors and baseline Covi anxiety score as the covariate.||0.50|-0.20|0.445
71058872|NCT02955212|141624418|SUPERIORITY||LS Mean Difference|-0.44|||<|0.001|TWO_SIDED|95.0|-0.55|-0.33|||ANCOVA|ANCOVA model including treatment as the fixed factor, and Baseline value and the stratification factor country as the covariates.|LS Mean Difference = Upadacitinib - Placebo|||-0.33|-0.55|<0.001
71058873|NCT02955212|141624419|SUPERIORITY||LS Mean Difference|5.57|||<|0.001|TWO_SIDED|95.0|4.13|7.01|||Mixed Effect Model Repeat Measurement|MMRM model with treatment, visit, treatment-by-visit interaction and stratification factor of country as fixed effects and Baseline value as covariate|LS Mean Difference = Upadacitinib - Placebo|||7.01|4.13|<0.001
71058874|NCT02955212|141624420|SUPERIORITY||Response Rate Difference|32.5|||<|0.001|TWO_SIDED|95.0|23.4|41.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor country.|Response Rate Difference = Upadacitinib - Placebo|||41.7|23.4|<0.001
70935384|NCT00257894|141371818|SUPERIORITY_OR_OTHER|||||||0.57||||||Effect size close to zero (eta squared of .01)|ANOVA|Interaction effect term from group by time ANOVA||||||.57
71058875|NCT02955212|141624421|SUPERIORITY||Response Rate Difference|24.3|||<|0.001|TWO_SIDED|24.3|16.6|31.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of country.|Response Rate Difference = Upadacitinib - Placebo|||31.9|16.6|<0.001
71058876|NCT02955212|141624422|SUPERIORITY||Response Rate Difference|24.3|||<|0.001|TWO_SIDED|95.0|15.6|32.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of country.|Response Rate Difference = Upadacitinib - Placebo|||32.9|15.6|<0.001
70935385|NCT00257894|141371819|SUPERIORITY_OR_OTHER|||||||0.6||||||Effect size about zero (eta squared = .01)|ANOVA|Interaction term from a group by time ANOVA||||||.60
70935386|NCT00257894|141371820|SUPERIORITY_OR_OTHER|||||||0.79||||||Effect size (eta squared) = 0|ANOVA|Interaction term of a group by time ANOVA||||||.79
70935387|NCT00257894|141371821|SUPERIORITY_OR_OTHER|||||||0.21||||||For test of drug by time interaction effect|ANOVA|Medium effect size, eta squared = .061||Analysis of variance, group by time (Day 0 vs. Day 10).||||.21
70935388|NCT02852824|141371824|OTHER||Slope|0.9058|STANDARD_ERROR_OF_MEAN|0.0523|||TWO_SIDED|95.0|0.7973|1.0142||||||Dose proportionality was explored using a regression model. A 95% confidence interval (CI) for the slope was computed. Power model is used a statistical method.||1.0142|0.7973|
71026122|NCT00384033|141559395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.056|TWO_SIDED|95.0|0.0|0.7||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, Covi anxiety scale was evaluated using ANCOVA with treatment and site as factors and baseline Covi anxiety score as the covariate.||0.70|-0.00|0.056
71058877|NCT02955212|141624423|SUPERIORITY||Response Rate Difference|32.5|||<|0.001|TWO_SIDED|95.0|24.0|41.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of country.|Response Rate Difference = Upadacitinib - Placebo|||41.0|24.0|<0.001
71058878|NCT02955212|141624424|SUPERIORITY||Response Rate Difference|17.8|||<|0.001|TWO_SIDED|95.0|11.0|24.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of country.|Response Rate Difference = Upadacitinib - Placebo|||24.5|11.0|<0.001
71058879|NCT02955212|141624425|SUPERIORITY||Response Rate Difference|19.5|||<|0.001|TWO_SIDED|95.0|12.1|27.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of country|Response Rate Difference = Upadacitinib - Placebo|||27.0|12.1|<0.001
71058880|NCT02664181|141624426|SUPERIORITY|||||||0.05|||||||Fisher Exact|||Partial remission rate was compared between both arms. The null hypothesis is that there is no difference in partial remission rate between the two arms, with a p-value of \< 0.05 indicating significance||||0.05
71058881|NCT02664181|141624427|SUPERIORITY||Hazard Ratio (HR)|0.4||||0.06|TWO_SIDED|95.0|0.13|1.21|||Log Rank|||||1.21|0.13|0.06
71109154|NCT01772550|141723897|NON_INFERIORITY_OR_EQUIVALENCE|A 95% upper confidence bound for the observed difference in percentages of images with acceptable quality between the control catheter and evaluation catheter was calculated using the Score method. The 20 G BD Nexiva™ Diffusics™ can be considered non-inferior for acceptable image quality if this 95% upper confidence bound is smaller than 15% (i.e. C - D \< 15% with 95% confidence). The non-inferiority margin was 15%.|Risk Difference (RD)|0.0|||||ONE_SIDED|95.0||2.6|||||The difference in percent of acceptable image quality is used as an estimate. The Score method was used to estimate the upper 95% confidence limit.|Only the percent of acceptable image quality from the randomized test and reference catheter groups were considered for this statistical analysis. If C is the percentage of acceptable quality images with the control catheter, and D is the percentage of images of acceptable quality with the evaluation catheter, and the non-inferiority criteria is 15%, the hypotheses to be tested are as follows: H0: C - D \> or = 15%; H1: C - D \< 15%.||2.6||
71109155|NCT01127633|141723937|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority margin for this hypothesis was specified as 50% of the treatment difference observed at the end of the feeder study. If the lower limit of the confidence interval (CI) was greater than 0, the noninferiority criterion was met, indicating that at least 50% of the treatment difference observed at the end of the feeder studies was maintained at specified time points in the delayed-start period.|Median Difference (Net)|-0.02||||0.974|TWO_SIDED|95.0|-1.14|1.11|||Mixed Models Analysis|||||1.11|-1.14|0.974
71109156|NCT00688467|141723952|SUPERIORITY_OR_OTHER||100 * (placebo - navarixin) / placebo|26.0|STANDARD_DEVIATION|27.377||0.411|||||||ANOVA|||||||0.411
71058882|NCT02664181|141624428|SUPERIORITY||Hazard Ratio (HR)|0.4||||0.19|TWO_SIDED|95.0|0.11|1.62|||Log Rank||Data from Kaplan-Meier analyses|||1.62|0.11|0.19
71058883|NCT02556801|141624465|SUPERIORITY||Test statistic|1.823||||0.057|ONE_SIDED||||||MCP-Mod Method|The primary dose-response analysis was performed by applying linear, Emax, logistic and exponential models.The p-value was based on Emax model.||||||0.057
71058884|NCT02556801|141624465|SUPERIORITY||Treatment effect|-1.96|STANDARD_DEVIATION|1.17|||TWO_SIDED|90.0|-3.89|-0.03||||||||-0.03|-3.89|
71058885|NCT02556801|141624465|SUPERIORITY||Treatment effect|-1.83|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|-3.72|0.06||||||||0.06|-3.72|
71109157|NCT00688467|141723953|SUPERIORITY_OR_OTHER||100 * (placebo - navarixin) / placebo|23.3|STANDARD_DEVIATION|0.306||0.292|||||||ANOVA|||||||0.292
71109158|NCT00688467|141723955|SUPERIORITY_OR_OTHER||100 * (placebo - navarixin) / placebo|-1.7|STANDARD_DEVIATION|16.261||0.927|||||||ANOVA|||||||0.927
71109159|NCT00688467|141723956|SUPERIORITY_OR_OTHER||100 * (placebo - navarixin) / placebo|4.3|STANDARD_DEVIATION|7.398||0.645|||||||ANOVA|||||||0.645
71109160|NCT02163577|141723965|SUPERIORITY||||||<|0.0001||||||Per generalized estimating equations (GEE) model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
71109161|NCT02163577|141723965|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
71109162|NCT02163577|141723965|SUPERIORITY||Difference in LS Means|-0.33|||||TWO_SIDED|95.0|-0.63|-0.04||||||Difference in change to Week 40||-0.04|-0.63|
71109163|NCT02163577|141723965|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
71058886|NCT02556801|141624465|SUPERIORITY||Treatment effect|-2.33|STANDARD_ERROR_OF_MEAN|1.15|||TWO_SIDED|90.0|-4.23|-0.43||||||||-0.43|-4.23|
71058887|NCT02556801|141624466|SUPERIORITY||Treatment effect|-1.92|STANDARD_ERROR_OF_MEAN|1.17|=|0.051|TWO_SIDED|90.0|-3.85|0.01|||Mixed Models Analysis|||||0.01|-3.85|=0.051
71058888|NCT02556801|141624466|SUPERIORITY||Treatment effect|-1.79|STANDARD_ERROR_OF_MEAN|1.14||0.059|TWO_SIDED|90.0|-3.68|0.1|||Mixed Models Analysis|||||0.10|-3.68|0.059
71058889|NCT02556801|141624466|SUPERIORITY||Treatment effect|-2.3|STANDARD_ERROR_OF_MEAN|1.15||0.024|TWO_SIDED|90.0|-4.2|-0.4|||Mixed Models Analysis|||||-0.40|-4.20|0.024
71058890|NCT02556801|141624467|SUPERIORITY||Treatment effect|-0.6|STANDARD_ERROR_OF_MEAN|1.08||0.291|TWO_SIDED|90.0|-2.39|1.19|||Mixed Models Analysis|||||1.19|-2.39|0.291
71058891|NCT02556801|141624467|SUPERIORITY||Treatment effect|-1.84|STANDARD_ERROR_OF_MEAN|1.06|=|0.042|TWO_SIDED|90.0|-3.6|-0.09|||Mixed Models Analysis|||||-0.09|-3.60|=0.042
71058892|NCT02556801|141624467|SUPERIORITY||Treatment effect|-1.78|STANDARD_ERROR_OF_MEAN|1.08||0.05|TWO_SIDED|90.0|-3.56|0.0|||Mixed Models Analysis|||||0.00|-3.56|0.050
71058893|NCT02556801|141624468|SUPERIORITY||Treatment effect|-0.89|STANDARD_ERROR_OF_MEAN|0.63|=|0.079|TWO_SIDED|90.0|-1.93|0.15|||Mixed Models Analysis|||||0.15|-1.93|=0.079
71058894|NCT02556801|141624468|SUPERIORITY||Treatment effect|-0.88|STANDARD_ERROR_OF_MEAN|0.61|=|0.076|TWO_SIDED|90.0|-1.89|0.13|||Mixed Models Analysis|||||0.13|-1.89|=0.076
71058895|NCT02556801|141624468|SUPERIORITY||Treatment effect|-1.11|STANDARD_ERROR_OF_MEAN|0.62|=|0.038|TWO_SIDED|0.62|-2.13|-0.08|||Mixed Models Analysis|||||-0.08|-2.13|=0.038
71058896|NCT02556801|141624469|SUPERIORITY||Treatment effect|-0.07|STANDARD_ERROR_OF_MEAN|0.58|=|0.451|TWO_SIDED|90.0|-1.03|0.88|||Mixed Models Analysis|||||0.88|-1.03|=0.451
71058897|NCT02556801|141624469|SUPERIORITY||Treatment effect|-0.62|STANDARD_ERROR_OF_MEAN|0.56|=|0.137|TWO_SIDED|90.0|-1.55|0.32|||Mixed Models Analysis|||||0.32|-1.55|=0.137
71058898|NCT02556801|141624469|SUPERIORITY||Treatment effect|-0.5|STANDARD_ERROR_OF_MEAN|0.57|=|0.195|TWO_SIDED|90.0|-1.45|0.46|||Mixed Models Analysis|||||0.46|-1.45|=0.195
71109164|NCT02163577|141723965|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
71109165|NCT02163577|141723965|SUPERIORITY||Difference in LS Means|-0.16|||||TWO_SIDED|95.0|-0.45|0.13||||||Difference in change to Week 64||0.13|-0.45|
71109166|NCT02163577|141723965|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
70935389|NCT02852824|141371825|OTHER||Slope|0.9528|STANDARD_ERROR_OF_MEAN|0.0454|||TWO_SIDED|95.0|0.8581|1.0475||||||Dose proportionality was explored using a regression model. A 95% confidence interval (CI) for the slope was computed. Power model is used as statistical method.||1.0475|0.8581|
70935390|NCT02852824|141371826|OTHER||Slope|0.9439|STANDARD_ERROR_OF_MEAN|0.0358|||TWO_SIDED|95.0|0.8697|1.0182||||||Dose proportionality was explored using a regression model. A 95% confidence interval (CI) for the slope was computed. Power model is used as statistical method.||1.0182|0.8697|
70935391|NCT02852824|141371827|OTHER||Slope|0.9708|STANDARD_ERROR_OF_MEAN|0.0351|||TWO_SIDED|95.0|0.8975|1.044||||||Dose proportionality was explored using a regression model. A 95% confidence interval (CI) for the slope was computed. Power model is used as statistical method.||1.0440|0.8975|
70935392|NCT02502461|141371829|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.04|TWO_SIDED|95.0|0.1|1.7||Bonferroni correction|t-test, 2 sided|||||1.7|0.1|0.04
71058899|NCT02556801|141624470|SUPERIORITY||Treatment effect|-0.354|STANDARD_ERROR_OF_MEAN|0.183|=|0.028|TWO_SIDED|90.0|-0.657|-0.05|||ANOVA|||||-0.050|-0.657|=0.028
71058900|NCT02556801|141624470|SUPERIORITY||Treatment effect|-0.394|STANDARD_ERROR_OF_MEAN|0.186|=|0.018|TWO_SIDED|90.0|-0.702|-0.086|||ANOVA|||||-0.086|-0.702|=0.018
71058901|NCT02556801|141624470|SUPERIORITY||Treatment effect|-0.28|STANDARD_ERROR_OF_MEAN|0.182|=|0.063|TWO_SIDED|90.0|-0.581|0.021|||ANOVA|||||0.021|-0.581|=0.063
71058902|NCT02556801|141624471|SUPERIORITY||Treatment effect|1.92|||<|0.001|TWO_SIDED|90.0|1.41|2.6|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 5 months (Visit 4)||2.60|1.41|<0.001
71058903|NCT02556801|141624471|SUPERIORITY||Treatment effect|2.43|||<|0.001|TWO_SIDED|90.0|1.8|3.27|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 5 months (Visit 4)||3.27|1.80|<0.001
71058904|NCT02556801|141624471|SUPERIORITY||Treatment effect|2.34|||<|0.001|TWO_SIDED|90.0|1.73|3.15|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 5 months (Visit 4)||3.15|1.73|<0.001
71058905|NCT02556801|141624471|SUPERIORITY||Treatment effect|1.42||||0.029|TWO_SIDED|90.0|1.05|1.93|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 10 months (Visit 6)||1.93|1.05|0.029
71058906|NCT02556801|141624471|SUPERIORITY||Treatment effect|1.67||||0.003|TWO_SIDED|90.0|1.24|2.25|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 10 months (Visit 6)||2.25|1.24|0.003
70935393|NCT03787628|141371835|OTHER|Generalized linear mixed model (GLMM) testing the main effect of group and time, and the group X time interaction.|F-test|0.703||||0.41|TWO_SIDED|||||P-value reflects the test of the interaction between group and time on the measure of cue-induced craving.|Mixed Models Analysis||Estimated value reflects the f test of the interaction between group and time on the measure of cue-induced craving (degrees of freedom = 1, 67).|||||0.41
70935394|NCT03787628|141371836|OTHER|Generalized linear mixed model (GLMM) testing the main effect of group and time, and the group X time interaction.|F-test|0.0||||0.99|TWO_SIDED|||||P-value reflects the test of the interaction between group and time on the measure of spontaneous craving.|Mixed Models Analysis||Estimated value reflects the f test of the interaction between group and time on spontaneous craving (degrees of freedom = 1, 550).|||||0.99
71058907|NCT02556801|141624471|SUPERIORITY||Treatment effect|1.37||||0.042|TWO_SIDED|90.0|1.01|1.85|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 10 months (Visit 6)||1.85|1.01|0.042
70935395|NCT03787628|141371837|OTHER|Generalized linear mixed model (GLMM) testing the main effect of group and time, and the group X time interaction.|F-test|0.04||||0.84|TWO_SIDED|||||P-value reflects the test of the interaction between group and time on the measure of state anxiety.|Mixed Models Analysis||Estimated value reflects the f test of the interaction between group and time on state anxiety (degrees of freedom = 1, 550)|||||0.84
70935396|NCT03787628|141371838|OTHER|Generalized linear mixed model (GLMM) testing the main effect of group and time, and the group X time interaction.|F-test|0.27||||0.6|TWO_SIDED|||||P-value reflects the test of the interaction between group and time on the measure of negative affect.|Mixed Models Analysis||Estimated value reflects the f test of the interaction between group and time on negative affect (degrees of freedom = 1, 550).|||||0.60
70935397|NCT04076059|141371839|SUPERIORITY||Cox Proportional Hazard|0.13|||<|0.0001|TWO_SIDED|95.0|0.076|0.222|||Log Rank||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|||0.222|0.076|<0.0001
70935398|NCT04076059|141371840|SUPERIORITY||Cox Proportional Hazard|0.33|||<|0.0001|TWO_SIDED|95.0|0.196|0.556|||Log Rank|Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.||||0.556|0.196|<0.0001
71058908|NCT02556801|141624472|SUPERIORITY||Treatment effect|1.11||||0.057|TWO_SIDED|90.0|1.0|1.23|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 5 months (Visit 4)||1.23|1.00|0.057
71058909|NCT02556801|141624472|SUPERIORITY||Treatment effect|1.29|||<|0.001|TWO_SIDED|90.0|1.17|1.43|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 5 months (Visit 4)||1.43|1.17|<0.001
71058910|NCT02556801|141624472|SUPERIORITY||Treatment effect|1.24|||<|0.001|TWO_SIDED|90.0|1.12|1.37|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 5 months (Visit 4)||1.37|1.12|<0.001
71058911|NCT02556801|141624472|SUPERIORITY||Treatment effect|1.23||||0.015|TWO_SIDED|90.0|1.05|1.45|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 10 months (Visit 6)||1.45|1.05|0.015
71058912|NCT02556801|141624472|SUPERIORITY||Treatment effect|1.6|||<|0.001|TWO_SIDED|90.0|1.37|1.87|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 10 months (Visit 6)||1.87|1.37|<0.001
71058913|NCT02556801|141624472|SUPERIORITY||Treatment effect|1.39|||<|0.001|TWO_SIDED|90.0|1.19|1.62|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 10 months (Visit 6)||1.62|1.19|<0.001
71058914|NCT02556801|141624472|SUPERIORITY||Treatment effect|0.99||||0.341|TWO_SIDED|90.0|0.93|1.04|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 5 months (Visit 4)||1.04|0.93|0.341
71058915|NCT02556801|141624472|SUPERIORITY||Treatment effect|1.1||||0.003|TWO_SIDED|90.0|1.04|1.16|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 5 months (Visit 4)||1.16|1.04|0.003
71058916|NCT02556801|141624472|SUPERIORITY||Treatment effect|1.02||||0.269|TWO_SIDED|90.0|0.97|1.08|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 5 months (Visit 4)||1.08|0.97|0.269
70935399|NCT04076059|141371841|SUPERIORITY||Cox Proportional Hazard|0.789||||0.7279|TWO_SIDED|95.0|0.208|2.998|||Log Rank|Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.||||2.998|0.208|0.7279
70935400|NCT04076059|141371842|SUPERIORITY||Cox Proportional Hazard|0.172|||<|0.0001|TWO_SIDED|95.0|0.107|0.276|||Log Rank|Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.||||0.276|0.107|<0.0001
70935401|NCT04076059|141371843|SUPERIORITY|||||||0.0036|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Stratified by volume of disease and previous docetaxel use during screening period. Parameter estimate: Difference in percentage||||||0.0036
71058917|NCT02556801|141624472|SUPERIORITY||Treatment effect|1.02||||0.312|TWO_SIDED|90.0|0.95|1.1|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 10 months (Visit 6)||1.10|0.95|0.312
71058918|NCT02556801|141624472|SUPERIORITY||Treatment effect|1.22|||<|0.001|TWO_SIDED|90.0|1.13|1.31|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 10 months (Visit 6)||1.31|1.13|<0.001
71058919|NCT02556801|141624472|SUPERIORITY||Treatment effect|1.11||||0.008|TWO_SIDED|90.0|1.03|1.2|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 10 months (Visit 6)||1.20|1.03|0.008
71058920|NCT02556801|141624472|SUPERIORITY||Treatment effect|1.04||||0.212|TWO_SIDED|90.0|0.96|1.14|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 5 months (Visit 4)||1.14|0.96|0.212
71058921|NCT02556801|141624472|SUPERIORITY||Treatment effect|1.16||||0.002|TWO_SIDED|90.0|1.07|1.27|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 5 months (Visit 4)||1.27|1.07|0.002
71058922|NCT02556801|141624472|SUPERIORITY||Treatment effect|1.15||||0.004|TWO_SIDED|90.0|1.06|1.25|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 5 months (Visit 4)||1.25|1.06|0.004
71109167|NCT02163577|141723965|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71109168|NCT02163577|141723966|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 40||||< 0.0001
71109169|NCT02163577|141723966|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 40||||< 0.0001
71109170|NCT02163577|141723966|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
71109171|NCT02163577|141723966|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
71109172|NCT02163577|141723966|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 160||||< 0.0001
70935402|NCT04076059|141371844|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Stratified by volume of disease and previous docetaxel use during screening period. Parameter estimate: Difference in percentage||||||<0.0001
70935403|NCT04076059|141371845|SUPERIORITY||Cox Proportional Hazard|0.797||||0.5899|TWO_SIDED|95.0|0.35|1.819|||Log Rank|Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.||||1.819|0.350|0.5899
70935404|NCT04076059|141371846|SUPERIORITY||Difference in Percentage|53.5|||<|0.0001|TWO_SIDED|95.0|40.1|66.9|||Cochran-Mantel-Haenszel|Stratified by volume of disease and previous docetaxel use during screening period. Parameter estimate: Difference in percentage||||66.9|40.1|<0.0001
70935405|NCT04076059|141371847|SUPERIORITY||Difference in Percentage|-5.2||||0.8312|TWO_SIDED|95.0|-25.4|14.9|||Cochran-Mantel-Haenszel|Stratified by volume of disease and previous docetaxel use during screening period. Parameter estimate: Difference in percentage||||14.9|-25.4|0.8312
70935406|NCT00768716|141371864|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||||||0.52
70935407|NCT00768716|141371865|OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
71058923|NCT02556801|141624472|SUPERIORITY||Treatment effect|1.09||||0.126|TWO_SIDED|90.0|0.96|1.24|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 10 months (Visit 6)||1.24|0.96|0.126
71058924|NCT02556801|141624472|SUPERIORITY||Treatment effect|1.28|||<|0.001|TWO_SIDED|90.0|1.13|1.45|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 10 months (Visit 6)||1.45|1.13|<0.001
71058925|NCT02556801|141624472|SUPERIORITY||Treatment effect|1.26||||0.002|TWO_SIDED|90.0|1.11|1.43|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 10 months (Visit 6)||1.43|1.11|0.002
70935408|NCT00768716|141371866|OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
70935409|NCT00768716|141371868|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
70935410|NCT00768716|141371869|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
71109173|NCT02163577|141723966|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 160||||< 0.0001
71109174|NCT02163577|141723967|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 40||||< 0.0001
71109175|NCT02163577|141723967|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 40||||< 0.0001
70935411|NCT00768716|141371870|OTHER|||||||0.003|||||||ANOVA|||||||0.003
71109176|NCT02163577|141723967|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
71109177|NCT02163577|141723967|SUPERIORITY|||||||0.0024|||||||one sample t test|||Week 64||||0.0024
71109178|NCT02163577|141723967|SUPERIORITY|||||||0.0018|||||||one sample t test|||Week 160||||0.0018
71109179|NCT02163577|141723967|SUPERIORITY|||||||0.0002|||||||one sample t test|||Week 160||||0.0002
71109180|NCT02163577|141723968|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 40||||< 0.0001
71109181|NCT02163577|141723968|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 40||||< 0.0001
71109182|NCT02163577|141723968|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
71109183|NCT02163577|141723968|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
71109184|NCT02163577|141723968|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 160||||< 0.0001
71109185|NCT02163577|141723968|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 160||||< 0.0001
71109186|NCT02163577|141723969|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes the change from baseline in RSS as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
71109187|NCT02163577|141723969|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes the change from baseline in RSS as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
70935412|NCT03769090|141371871|SUPERIORITY||Hazard Ratio (HR)|0.733|||<|0.001|TWO_SIDED|95.0|0.611|0.879|||Regression, Cox|||H0 = null hypothesis. Hazard ratios, 95% confidence intervals for hazard ratios and p-values are estimated using a Cox regression model with treatment group, age group, region and number of severe exacerbations in the last 12 months prior to randomization as factors. A hazard ratio less than 1 favours BDA MDI treatment.||0.879|0.611|<0.001
70935413|NCT03769090|141371871|SUPERIORITY||Hazard Ratio (HR)|0.835||||0.041|TWO_SIDED|95.0|0.702|0.992|||Regression, Cox|||H0 = Null hypothesis. Hazard ratios, 95% confidence intervals for hazard ratios and p-values are estimated using a Cox regression model with treatment group, age group, region and number of severe exacerbations in the last 12 months prior to randomization as factors. A hazard ratio less than 1 favours BDI MDI treatment.||0.992|0.702|0.041
70935414|NCT03769090|141371872|SUPERIORITY||Rate Ratio|0.76||||0.008|TWO_SIDED|95.0|0.62|0.93|||Negative binomial model|||Estimated from a negative binomial model with treatment, age group, region, and number of severe exacerbations in the last 12 months prior to randomization as categorical covariates. The logarithm of the time at risk is included as an offset variable. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||0.93|0.62|0.008
70935415|NCT03769090|141371872|SUPERIORITY||Rate Ratio|0.8||||0.028|TWO_SIDED|95.0|0.66|0.98|||Negative binomial model|||Estimated from a negative binomial model with treatment, age group, region, and number of severe exacerbations in the last 12 months prior to randomization as categorical covariates. The logarithm of the time at risk is included as an offset variable. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||0.98|0.66|0.028
70935416|NCT03769090|141371873|SUPERIORITY|||||||0.002|||||||Wilcoxon rank sum|||P-values are calculated via a Wilcoxon rank sum test. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||||0.002
70935417|NCT03769090|141371873|SUPERIORITY|||||||0.06|||||||Wilcoxon rank sum|||P-values are calculated via a Wilcoxon rank sum test. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||||0.06
70935418|NCT03769090|141371874|SUPERIORITY||Odds Ratio (OR)|1.221||||0.033|TWO_SIDED|95.0|1.016|1.467|||Regression, Logistic|||Logistic regression model with baseline ACQ-5 as a continuous covariate and age group, region and number of severe exacerbations in the 12 months prior to randomization as categorical covariates. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||1.467|1.016|0.033
70935419|NCT03769090|141371874|SUPERIORITY||Odds Ratio (OR)|1.132||||0.175|TWO_SIDED|95.0|0.946|1.353|||Regression, Logistic|||Logistic regression model with baseline ACQ-5 as a continuous covariate and age group, region and number of severe exacerbations in the 12 months prior to randomization as categorical covariates. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||1.353|0.946|0.175
70935420|NCT03769090|141371875|SUPERIORITY||Odds Ratio (OR)|1.228||||0.028|TWO_SIDED|95.0|1.022|1.475|||Regression, Logistic|||Logistic regression model with baseline AQLQ-12 as a continuous covariate and age group, region and number of severe exacerbations in the 12 months prior to randomization as categorical covariates. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||1.475|1.022|0.028
70935421|NCT03769090|141371875|SUPERIORITY||Odds Ratio (OR)|1.111||||0.26|TWO_SIDED|95.0|0.925|1.335|||Regression, Logistic|||Logistic regression model with baseline AQLQ-12 as a continuous covariate and age group, region and number of severe exacerbations in the 12 months prior to randomization as categorical covariates. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||1.335|0.925|0.26
70935422|NCT00799409|141371876|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.6|||<|0.0001|TWO_SIDED|95.0|-35.0|-22.3||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score adjusted by Hochberg's step up procedure|Mixed Models Analysis||Placebo minus CONCERTA|||-22.3|-35.0|<0.0001
70935423|NCT00799409|141371877|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.3|||<|0.0001|TWO_SIDED|95.0|-34.4|-22.2||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score adjusted by Hochberg's step up procedure|Mixed Models Analysis||Placebo minus CONCERTA|||-22.2|-34.4|<0.0001
70935424|NCT00799409|141371878|SUPERIORITY_OR_OTHER||LS Mean Difference|5.9|||<|0.0001|TWO_SIDED|95.0|4.3|7.4||P-Values are determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis|P-Values at each timepoint are determined by using contrast statements in the repeated measures mixed model.|Placebo minus CONCERTA|||7.4|4.3|<0.0001
71026123|NCT00384033|141559395|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.5||||0.006|TWO_SIDED|95.0|0.1|0.9||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, Covi anxiety scale was evaluated using ANCOVA with treatment and site as factors and baseline Covi anxiety score as the covariate.||0.90|0.10|0.006
71026124|NCT00384033|141559396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.124|TWO_SIDED|95.0|-0.9|7.9||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, overall VAS-PI score was evaluated using ANCOVA with treatment and site as factors and baseline VAS-PI score as the covariate.||7.90|-0.90|0.124
71026125|NCT00384033|141559396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7||||0.035|TWO_SIDED|95.0|0.3|9.1||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, overall VAS-PI score was evaluated using ANCOVA with treatment and site as factors and baseline VAS-PI score as the covariate.||9.10|0.30|0.035
71058926|NCT02556801|141624473|SUPERIORITY||Treatment effect|1.33||||0.032|TWO_SIDED|90.0|1.03|1.7|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 5 months (Visit 4)||1.70|1.03|0.032
70935425|NCT00799409|141371879|SUPERIORITY_OR_OTHER||LS Mean Difference|5.1|||<|0.0001|TWO_SIDED|95.0|3.8|6.5||P-Values are determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis|P-Values at each timepoint are determined by using contrast statements in the repeated measures mixed model.|Placebo minus CONCERTA|||6.5|3.8|<0.0001
70935426|NCT00799409|141371880|SUPERIORITY_OR_OTHER||LS Mean Difference|11.0|||<|0.0001|TWO_SIDED|95.0|8.7|13.3||P-Values are determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis|P-Values at each timepoint are determined by using contrast statements in the repeated measures mixed model.|Placebo minus CONCERTA|||13.3|8.7|<0.0001
71058927|NCT02556801|141624473|SUPERIORITY||Treatment effect|2.15|||<|0.001|TWO_SIDED|90.0|1.68|2.74|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 5 months (Visit 4)||2.74|1.68|<0.001
71058928|NCT02556801|141624473|SUPERIORITY||Treatment effect|2.03|||<|0.001|TWO_SIDED|90.0|1.59|2.59|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 5 months (Visit 4)||2.59|1.59|<0.001
71058929|NCT02556801|141624473|SUPERIORITY||Treatment effect|1.48||||0.024|TWO_SIDED|90.0|1.07|2.06|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 10 months (Visit 6)||2.06|1.07|0.024
71058930|NCT02556801|141624473|SUPERIORITY||Treatment effect|2.88|||<|0.001|TWO_SIDED|90.0|2.09|3.98|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 10 months (Visit 6)||3.98|2.09|<0.001
71058931|NCT02556801|141624473|SUPERIORITY||Treatment effect|2.12|||<|0.001|TWO_SIDED|90.0|1.54|2.93|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 10 months (Visit 6)||2.93|1.54|<0.001
71058932|NCT02556801|141624473|SUPERIORITY||Treatment effect|1.18||||0.102|TWO_SIDED|90.0|0.95|1.47|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 5 months (Visit 4)||1.47|0.95|0.102
71058933|NCT02556801|141624473|SUPERIORITY||Treatment effect|1.99|||<|0.001|TWO_SIDED|90.0|1.61|2.46|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 5 months (Visit 4)||2.46|1.61|<0.001
71058934|NCT02556801|141624473|SUPERIORITY||Treatment effect|1.57|||<|0.001|TWO_SIDED|90.0|1.27|1.94|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 5 months (Visit 4)||1.94|1.27|<0.001
71058935|NCT02556801|141624473|SUPERIORITY||Treatment effect|1.39||||0.019|TWO_SIDED|90.0|1.07|1.81|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 10 months (Visit 6)||1.81|1.07|0.019
70935427|NCT00799409|141371881|SUPERIORITY_OR_OTHER||LS Means Difference|-3.16|||<|0.0001|TWO_SIDED|95.0|-3.72|-2.59||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-2.59|-3.72|<0.0001
70935428|NCT00799409|141371882|SUPERIORITY_OR_OTHER||LS Means Difference|-16.03|||<|0.0001|TWO_SIDED|95.0|-19.99|-12.06||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-12.06|-19.99|<0.0001
70935429|NCT00799409|141371883|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.45|||<|0.0001|TWO_SIDED|95.0|-27.43|-17.47||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-17.47|-27.43|<0.0001
70935430|NCT00799409|141371884|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.93||||0.18|TWO_SIDED|95.0|-1.69|-0.16||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-0.16|-1.69|0.1800
70935431|NCT00799409|141371885|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.32||||0.0057|TWO_SIDED|95.0|-2.25|-0.4||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-0.40|-2.25|0.0057
70935432|NCT00799409|141371886|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.3||||0.1091|TWO_SIDED|95.0|-14.05|1.44||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||1.44|-14.05|0.1091
71058936|NCT02556801|141624473|SUPERIORITY||Treatment effect|2.38|||<|0.001|TWO_SIDED|90.0|1.84|3.08|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 10 months (Visit 6)||3.08|1.84|<0.001
71058937|NCT02556801|141624473|SUPERIORITY||Treatment effect|1.7|||<|0.001|TWO_SIDED|90.0|1.31|2.19|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 10 months (Visit 6)||2.19|1.31|<0.001
71058938|NCT02556801|141624473|SUPERIORITY||Treatment effect|1.52||||0.048|TWO_SIDED|90.0|1.01|2.31|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 5 months (Visit 4)||2.31|1.01|0.048
71058939|NCT02556801|141624473|SUPERIORITY||Treatment effect|2.35|||<|0.001|TWO_SIDED|90.0|1.56|3.53|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 5 months (Visit 4)||3.53|1.56|<0.001
71058940|NCT02556801|141624473|SUPERIORITY||Treatment effect|2.83|||<|0.001|TWO_SIDED|90.0|1.88|4.24|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 5 months (Visit 4)||4.24|1.88|<0.001
71058941|NCT02556801|141624473|SUPERIORITY||Treatment effect|1.67||||0.04|TWO_SIDED|90.0|1.03|2.69|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 10 months (Visit 6)||2.69|1.03|0.040
71058942|NCT02556801|141624473|SUPERIORITY||Treatment effect|2.68|||<|0.001|TWO_SIDED|90.0|1.67|4.3|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 10 months (Visit 6)||4.30|1.67|<0.001
71058943|NCT02556801|141624473|SUPERIORITY||Treatment effect|2.88|||<|0.001|TWO_SIDED|90.0|1.8|4.62|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 10 months (Visit 6)||4.62|1.80|<0.001
71058944|NCT03668808|141624476|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is there was no difference in Time in Range (70-140mg/dl) in the initial 24 hours at destination, whether after Eastward travel or Westward travel, between Insulin Degludec \& Insulin Glargine U100. Travel direction not tested. Criterion for significance set at 0.05; using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the standard deviation of the difference is \<106 minutes.||||<0.05
71026126|NCT00384033|141559396|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.1||||0.093|TWO_SIDED|95.0|-0.7|8.8||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, overall VAS-PI score was evaluated using ANCOVA with treatment and site as factors and baseline VAS-PI score as the covariate.||8.80|-0.70|0.093
71026127|NCT00384033|141559396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1||||0.177|TWO_SIDED|95.0|-1.4|7.7||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, stomach pain score was evaluated using ANCOVA with treatment and site as factors and baseline stomach pain score as the covariate.||7.70|-1.40|0.177
71026128|NCT00384033|141559396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6||||0.048|TWO_SIDED|95.0|0.1|9.1||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, stomach pain score was evaluated using ANCOVA with treatment and site as factors and baseline stomach pain score as the covariate.||9.10|0.10|0.048
71026129|NCT00384033|141559396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8||||0.088|TWO_SIDED|95.0|-0.5|8.1||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, stomach pain score was evaluated using ANCOVA with treatment and site as factors and baseline stomach pain score as the covariate.||8.10|-0.50|0.088
71026130|NCT00384033|141559396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7||||0.122|TWO_SIDED|95.0|-1.0|8.4||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, back pain score was evaluated using ANCOVA with treatment and site as factors and baseline back pain score as the covariate.||8.40|-1.00|0.122
71026131|NCT00384033|141559396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8||||0.015|TWO_SIDED|95.0|1.1|10.5||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, back pain score was evaluated using ANCOVA with treatment and site as factors and baseline back pain score as the covariate.||10.50|1.10|0.015
71026132|NCT00384033|141559396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2||||0.103|TWO_SIDED|95.0|-0.8|9.2||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, back pain score was evaluated using ANCOVA with treatment and site as factors and baseline back pain score as the covariate.||9.20|-0.80|0.103
71026133|NCT00384033|141559396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.384|TWO_SIDED|95.0|-1.7|4.5||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, chest pain score was evaluated using ANCOVA with treatment and site as factors and baseline chest pain score as the covariate.||4.50|-1.70|0.384
71026134|NCT00384033|141559396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.221|TWO_SIDED|95.0|-1.2|5.1||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, chest pain score was evaluated using ANCOVA with treatment and site as factors and baseline chest pain score as the covariate.||5.10|-1.20|0.221
71026135|NCT00384033|141559396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.411|TWO_SIDED|95.0|-1.9|4.7||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, chest pain score was evaluated using ANCOVA with treatment and site as factors and baseline chest pain score as the covariate.||4.70|-1.90|0.411
71026136|NCT00384033|141559396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.412|TWO_SIDED|95.0|-2.8|6.7||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, arms, legs, joint pain score was evaluated using ANCOVA with treatment and site as factors and baseline arms, legs, pain score as the covariate.||6.70|-2.80|0.412
71058945|NCT03668808|141624477|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05|t-test, 2 sided|||Null hypothesis is there was no difference in Time in Range (70-180mg/dl) in the initial 24 hours at destination, whether after Eastward travel or Westward travel, between Insulin Degludec \& Insulin Glargine U100. Travel direction not tested. Criterion for significance set at 0.05; using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the standard deviation of the difference is \<106 minutes.||||<0.05
71058946|NCT03668808|141624478|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is there was no difference in Mean ± SD CGM glucose (mg/dl) in flight, East or West travel, and in 72 hours at destination, whether after East or West travel, between Insulin Degludec \& Insulin Glargine U100. Travel direction not tested. Criterion for significance was at 0.05. Using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the SD of the difference is \<106 minutes.||||<0.05
71058947|NCT03668808|141624479|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is that there was no difference in CGM % time \<70 mg/dl in flight, East or West travel, and in 72 hours at destination, whether after East or West travel, between Insulin Degludec and Insulin Glargine U100. Travel direction not tested. Criterion for significance was at 0.05. Using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the SD of the difference is \<106 minutes.||||<0.05
71058948|NCT03668808|141624480|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is that there was no difference in CGM % time 70-180 mg/dl in flight, East or West travel, and in 72 hours at destination, whether after East or West travel, between Insulin Degludec \& Insulin Glargine U100. Travel direction not tested. Criterion for significance was at 0.05. Using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the SD of the difference is \<106 minutes.||||<0.05
71026137|NCT00384033|141559396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9||||0.042|TWO_SIDED|95.0|0.2|9.6||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, arms, legs, joint pain score was evaluated using ANCOVA with treatment and site as factors and baseline arms, legs, pain score as the covariate.||9.60|0.20|0.042
70935433|NCT00799409|141371887|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25||||0.2653|TWO_SIDED|95.0|-0.7|0.2||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.20|-0.70|0.2653
71058949|NCT03668808|141624481|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is that there was no difference in CGM % time \>180 mg/dl in flight, East or West travel, and in 72 hours at destination, whether after East or West travel, between Insulin Degludec \& Insulin Glargine U100. Travel direction not tested. Criterion for significance was at 0.05. Using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the SD of the difference is \<106 minutes.||||<0.05
71058950|NCT03668808|141624482|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is there was no difference in CGM - Coefficient of Variation (CV) in flight, East or West travel, and in 72 hours at destination, whether after East or West travel, between Insulin Degludec \& Insulin Glargine U100. Travel direction not tested. Criterion for significance was at 0.05. Using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the SD of the difference is \<106 minutes.||||<0.05
71058951|NCT03668808|141624483|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is there was no difference in CGM Fasting Blood Glucose (FBG) at 0600 local time at destination, whether after East or West travel, between Insulin Degludec and Insulin Glargine U100. Travel direction not tested. Criterion for significance was set at 0.05, and using a paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the standard deviation of the difference is \<106 minutes.||||<0.05
71058952|NCT03668808|141624484|SUPERIORITY||||||<|0.01||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is that there was no difference in Liverpool Jet-Lag Questionnaire after 24 and 48 hours at the destination, whether after Eastward travel or after Westward travel, between Insulin Degludec and Insulin Glargine U100. Travel direction not tested. The criterion for significance was set at 0.05, and using a paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins.||||<0.01
71058953|NCT03668808|141624485|SUPERIORITY||||||<|0.05||||||The tests were performed with a significance level of 0.05 (two-sided).|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in Sleep quantity measured by ActiGraph in 24 hours at the destination, whether after Eastward or after Westward travel, between Insulin Degludec and Insulin Glargine U100. Travel direction not tested. The criterion for significance was set at 0.05, and using a paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins.||||<0.05
71058954|NCT03668808|141624486|SUPERIORITY||||||<|0.05||||||The tests were performed with a significance level of 0.05 (two-sided).|Wilcoxon (Mann-Whitney)|||Null hypothesis is there was no difference in Sleep efficiency measured by ActiGraph in 24 hours at the destination, whether after Eastward or after Westward travel, between Insulin Degludec and Insulin Glargine U100. Travel direction not tested. The criterion for significance was set at 0.05, and using a paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins.||||<0.05
71058955|NCT05274178|141624489|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>.05
71058956|NCT05274178|141624489|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>.05
71058957|NCT02839772|141624490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.581|STANDARD_ERROR_OF_MEAN|0.296|<|0.001|TWO_SIDED|95.0|0.997|2.164|||Mixed Models Analysis|t=5.341, df=89.347||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function (SBF) in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in TEWL at the top of the outer lower legs by group from baseline after 3 months of interventions."||2.164|0.997|<0.001
71058958|NCT02839772|141624491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.684|STANDARD_ERROR_OF_MEAN|0.346|<|0.001|TWO_SIDED|95.0|1.002|2.367|||Mixed Models Analysis|t=4.871, df=189.789||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in TEWL at the mid-point of the outer lower legs by group from baseline after 3 months of interventions."||2.367|1.002|<0.001
71109188|NCT02163577|141723969|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
71109189|NCT02163577|141723969|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
71109190|NCT02163577|141723969|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71109191|NCT02163577|141723969|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71109192|NCT02163577|141723970|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes the change from baseline in RSS as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
70935434|NCT00799409|141371888|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.49||||0.0038|TWO_SIDED|95.0|-10.81|-2.17||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-2.17|-10.81|0.0038
70935435|NCT00799409|141371889|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.75||||0.0001|TWO_SIDED|95.0|-6.96|-2.53||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-2.53|-6.96|0.0001
70935436|NCT00799409|141371890|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.76||||0.0092|TWO_SIDED|95.0|-10.04|-1.47||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-1.47|-10.04|0.0092
71058959|NCT02839772|141624492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.97|STANDARD_ERROR_OF_MEAN|0.386|<|0.001|TWO_SIDED|95.0|1.21|2.731|||Mixed Models Analysis|t=5.111, df=189.620||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in TEWL at the base of the outer lower legs by group from baseline after 3 months of interventions."||2.731|1.210|<0.001
71058960|NCT02839772|141624493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.751|STANDARD_ERROR_OF_MEAN|0.39||0.002|TWO_SIDED|95.0|0.656|2.846|||Mixed Models Analysis|t=3.154, df=189.580||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in TEWL at the top of the feet by group from baseline after 3 months of interventions."||2.846|0.656|0.002
71058961|NCT02839772|141624494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.075|STANDARD_ERROR_OF_MEAN|0.515|<|0.001|TWO_SIDED|95.0|-3.042|-1.1078|||Mixed Models Analysis|t=-4.236,df=165.310||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in SCH at the top of the outer lower legs by group from baseline after 3 months of interventions."||-1.1078|-3.042|<0.001
71058962|NCT02839772|141624495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.658|STANDARD_ERROR_OF_MEAN|0.467|<|0.001|TWO_SIDED|95.0|-2.581|-0.736|||Mixed Models Analysis|t=-3.549, df=180.923||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in SCH at the mid-point of the outer lower legs by group from baseline after 3 months of interventions."||-0.736|-2.581|<0.001
71058963|NCT02839772|141624496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.641|STANDARD_ERROR_OF_MEAN|0.473||0.001|TWO_SIDED|95.0|-2.574|-0.708|||Mixed Models Analysis|t=-3.471, df=186.308||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in SCH at the base of the outer lower legs by group from baseline after 3 months of interventions."||-0.708|-2.574|0.001
71058964|NCT02839772|141624497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.041|STANDARD_ERROR_OF_MEAN|0.572|<|0.001|TWO_SIDED|95.0|-3.168|-0.911|||Mixed Models Analysis|t=-3.565, df=186.739||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in SCH at the base of the top of the feet by group from baseline after 3 months of interventions."||-0.911|-3.168|<0.001
71058965|NCT02839772|141624498|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.452|STANDARD_ERROR_OF_MEAN|0.255||0.076|TWO_SIDED|95.0|-0.048|0.952||A cumulative logistic link function was used|Generalized estimating equation analysis|Wald Chi squared=3.138, df=1||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds of the stage of podoconiosis by group being more severe at the 4th visit."||0.952|-0.048|0.076
71058966|NCT02839772|141624499|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.224||||0.527|TWO_SIDED|95.0|-0.469|0.917||A Bernouilli distribution with a logistic link function was used.|Generalized estimating equation analysis|Wald chi-square=0.410, df=1||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds of mossy changes being present in the lower legs/feet by group at the 4th visit."||0.917|-0.469|0.527
71058967|NCT02839772|141624500|SUPERIORITY_OR_OTHER||Odds Ratio, log|-1.29|STANDARD_ERROR_OF_MEAN|0.446||0.031|TWO_SIDED|95.0|-2.161|-0.411||A Bernouilli distribution with a logistic link function was used|Generalized estimating equation analysis|Wald chi-square=8.304, df=1||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds of participants having a bad odour emanating from their lower legs/feet by group at the 4th visit. Bad odour results in a decease in quality of life."||-0.411|-2.161|0.031
71109193|NCT02163577|141723970|SUPERIORITY|||||||0.0015||||||ANCOVA model includes the change from baseline in RSS as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||0.0015
71109194|NCT02163577|141723970|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
71109195|NCT02163577|141723970|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
70935437|NCT00799409|141371891|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.9195|TWO_SIDED|95.0|-0.37|0.33||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.33|-0.37|0.9195
70935438|NCT00799409|141371892|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.55||||0.0002|TWO_SIDED|95.0|-59.7|-19.39||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-19.39|-59.70|0.0002
70935439|NCT00799409|141371893|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.0002|TWO_SIDED|95.0|-0.13|-0.04||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-0.04|-0.13|0.0002
71058968|NCT02839772|141624501|SUPERIORITY_OR_OTHER||Odds Ratio, log|2.062|STANDARD_ERROR_OF_MEAN|0.741||0.005|TWO_SIDED|95.0|0.61|3.514||A Poisson distribution with a logarithmic link function was used|Generalized estimating equation analysis|Wald chi-square=7.745, df=1||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds of wounds being present on the lower legs/feet of participants by group at the 4th visit."||3.514|0.610|0.005
71058969|NCT02839772|141624502|SUPERIORITY_OR_OTHER||Group ratio estimate|2.09|STANDARD_ERROR_OF_MEAN|1.102||0.058|TWO_SIDED|0.058|-0.069|4.25||A Poisson distribution with a logarithmic link function was used.|Generalized estimation equation|df=1|Those in the experimental group were expected to have fewer work days lost due to ADL.|"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds by group of having had fewer work days lost in the previous month at the 4th visit due to ADL."||4.250|-0.069|0.058
71058970|NCT02839772|141624503|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value was \< 0.001 at all time points.|Spearman's correlation coefficient|The correlation at the 1st visit was 0.252, at the 2nd 0.306, at the 3rd 0.291 and at the 4th 0.265.||The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.||||<0.001
71058971|NCT02839772|141624504|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.288|STANDARD_ERROR_OF_MEAN|0.204||0.158|TWO_SIDED|95.0|-0.113|0.69|||Mixed Models Analysis|df=185.386||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~A reduction in leg circumference indicates an improvement in the disease."||0.690|-0.113|0.158
71058972|NCT02839772|141624505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.575|STANDARD_ERROR_OF_MEAN|0.162|<|0.001|TWO_SIDED|95.0|0.255|0.895|||Mixed Models Analysis|df=169.916, t=3.550||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~A reduction in foot circumference indicates an improvement in the disease."||0.895|0.255|<0.001
71058973|NCT02839772|141624506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.063|STANDARD_ERROR_OF_MEAN|0.54||0.907|TWO_SIDED|95.0|-1.129|1.002|||Mixed Models Analysis|t=-0.117, df=178.814||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Podoconiosis has a large effect on a person's quality of life. abnormal looking legs/feet, wounds and the related bad odour plus social isolation result in stigma and social isolation.."||1.002|-1.129|0.907
71058974|NCT01965860|141624508|SUPERIORITY|||||||0.001|||||||ANOVA|||"Prior to the study a power analysis was performed to calculate the number of participants required in each of the three groups. Previous work comparing OSATS derived scores in endovascular interventions shows a Cohen D of two. Using a of .05, a power of .80, and an expected dropout rate of 10%, the minimum number of surgical trainees required per group was seven.~Null hypothesis for primary outcome: no difference in technical performance during real life procedures between the three groups"||||0.001
71058975|NCT01965860|141624508|OTHER|||||||0.003|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test MCQ score||||0.003
71058976|NCT01965860|141624508|OTHER|||||||0.001|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test MCQ score||||0.001
71058977|NCT01965860|141624508|OTHER|||||||0.228|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test MCQ score||||0.228
71058978|NCT01965860|141624508|OTHER|||||||0.001|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test GRS score||||0.001
71058979|NCT01965860|141624508|OTHER|||||||0.008|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test GRS score||||0.008
71109196|NCT02163577|141723970|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
70935440|NCT00799409|141371894|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.4625|TWO_SIDED|95.0|-0.07|0.03||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.03|-0.07|0.4625
71058980|NCT01965860|141624508|OTHER|||||||0.164|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test GRS score||||0.164
71109197|NCT02163577|141723970|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71109198|NCT02163577|141723971|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
70935441|NCT00799409|141371895|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.6262|TWO_SIDED|95.0|-0.09|0.05||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.05|-0.09|0.6262
70935442|NCT00799409|141371896|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.998|TWO_SIDED|95.0|-0.08|0.08||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.08|-0.08|0.9980
70935443|NCT00799409|141371897|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.0151|TWO_SIDED|95.0|-0.19|-0.02||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-0.02|-0.19|0.0151
71109199|NCT02163577|141723971|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
71109200|NCT02163577|141723971|SUPERIORITY||Difference in LS Means|0.21|||||TWO_SIDED|95.0|-0.12|0.54||||||Difference in change to Week 40||0.54|-0.12|
71109201|NCT02163577|141723971|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
71109202|NCT02163577|141723971|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
71109203|NCT02163577|141723971|SUPERIORITY||Difference in LS Means|-0.02|||||TWO_SIDED|95.0|-0.34|0.29||||||Difference in change to Week 64||0.29|-0.34|
71109204|NCT02163577|141723971|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71109205|NCT02163577|141723971|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
70852195|NCT03615040|141192854|SUPERIORITY||Incidence Rate Ratio|0.78|STANDARD_ERROR_OF_MEAN|0.15||0.195|TWO_SIDED|95.0|0.53|1.14|||t-test, 2 sided|||A generalised linear model (assuming neg. binomial distribution) was used. The model includes the number of exacerbations during the 48 week treatment as an outcome with explanatory variables of treatment arm \& number of exacerbations in the 12 months prior to the trial (stratification factor), and log-time on trial (in weeks) as an offset. The offset, allows for different lengths of time in the trial. Only observed exacerbations were used alongside the corresponding time period in the offset.||1.14|0.53|0.195
70852196|NCT03615040|141192857|SUPERIORITY||Mean Difference (Net)|-3.3||||0.039|TWO_SIDED|95.0|-6.4|-0.2|||Mixed Models Analysis|||Calculated using mixed effect linear model with dependent variable of the outcome at baseline and follow-up time points (Week 4, 12, 24, 36, 48); explanatory variables of treatment arm, number of exacerbations in the 12 months prior to the trial (stratification factor), visit time point (as categorical variable), baseline score; an interaction term between treatment and visit as fixed effects; and patient identification as a random effect.||-0.2|-6.4|0.039
71058981|NCT01965860|141624508|OTHER|||||||0.001|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test Examiner's checklist score||||0.001
71058982|NCT01965860|141624508|OTHER|||||||0.001|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test Examiner's checklist score||||0.001
71058983|NCT01965860|141624508|OTHER|||||||0.19|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test Examiner's checklist score||||0.190
71058984|NCT03735121|141624512|NON_INFERIORITY|The null hypothesis that atezolizumab SC is inferior to atezolizumab IV is rejected if the lower bound of the 2-sided 90% confidence interval \[CI\] of the geometric mean ratio is greater than or equal to (≥) the non-inferiority margin 0.8.|Geometric mean ratio|1.05|||||TWO_SIDED|90.0|0.88|1.24||||||||1.24|0.88|
71058985|NCT03735121|141624513|NON_INFERIORITY|The null hypothesis that atezolizumab SC is inferior to atezolizumab IV is rejected if the lower bound of the 2-sided 90% CI of the geometric mean ratio is ≥ the non-inferiority margin 0.8.|Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.83|0.92||||||||0.92|0.83|
71058986|NCT04194645|141624626|OTHER|The statistical model used for the analysis of the endpoint was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio of geometric mean (T2/R)|97.71|||||TWO_SIDED|90.0|91.45|104.4|||ANOVA||Intra- individual coefficient of variation (gCV %) = 8.9|No formal hypothesis was tested.||104.40|91.45|
71058987|NCT04194645|141624626|OTHER|The statistical model used for the analysis of the endpoint was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio of geometric mean (T1/T2)|112.88|||||TWO_SIDED|90.0|98.82|128.94|||ANOVA||Intra- individual coefficient of variation (gCV %) = 16.8|No formal hypothesis was tested.||128.94|98.82|
71109206|NCT02163577|141723972|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
71109207|NCT02163577|141723972|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
71109208|NCT02163577|141723972|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
71109209|NCT02163577|141723972|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
71109210|NCT02163577|141723972|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71109211|NCT02163577|141723972|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71109212|NCT02163577|141723973|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
71109213|NCT02163577|141723973|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
71109214|NCT02163577|141723973|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
70935444|NCT00799409|141371898|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09||||0.0043|TWO_SIDED|95.0|-0.15|-0.03||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-0.03|-0.15|0.0043
70935445|NCT00799409|141371899|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.0371|TWO_SIDED|95.0|-0.08|0.0||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.00|-0.08|0.0371
71077956|NCT01153009|141664424|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|1.21||0.023|TWO_SIDED|95.0|-5.12|-0.38||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.025, hierarchical testing continues for this dose.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||-0.38|-5.12|0.023
70935446|NCT00799409|141371900|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.0965|TWO_SIDED|95.0|-0.06|0.01||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.01|-0.06|0.0965
70941715|NCT04748445|141383935|OTHER||Slope|-1.324|STANDARD_ERROR_OF_MEAN|8.289||0.1128|TWO_SIDED|90.0|-2.698|4.973|||Mixed Models Analysis|||EE\_MFCC 1st order delta 05 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit and estimated value it was 10\^-3. For upper limit it was 10\^-5 and for dispersion value it was 10\^-4).||4.973|-2.698|0.1128
71026138|NCT00384033|141559396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3||||0.155|TWO_SIDED|95.0|-1.2|7.8||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, arms, legs, joint pain score was evaluated using ANCOVA with treatment and site as factors and baseline arms, legs, pain score as the covariate.||7.80|-1.20|0.155
71026139|NCT00290745|141559397|OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Change in Tumor volume between baseline and Month 6||||0.07
71026140|NCT00290745|141559398|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change in Tumor volume between baseline and Month 6||||<0.001
71026141|NCT00290745|141559401|OTHER|||||||0.538|||||||Kruskal-Wallis|||||||0.538
71026142|NCT00290745|141559402|OTHER|||||||0.02|||||||Kruskal-Wallis|||||||0.02
71026143|NCT00290745|141559403|OTHER|||||||0.714|||||||Kruskal-Wallis|||||||0.714
71026144|NCT00290745|141559404|OTHER|||||||0.001|||||||Kruskal-Wallis|||||||0.001
71026145|NCT00290745|141559405|OTHER|||||||0.906|||||||Kruskal-Wallis|||||||0.906
71026146|NCT02750306|141559406|SUPERIORITY||Difference in Least Squares Means|28.2||||0.00128|TWO_SIDED|95.0|11.1|45.2|||ANCOVA|||||45.2|11.1|0.00128
71026147|NCT02750306|141559409|SUPERIORITY||Difference in Least Squares Means|-15.7||||0.01354|TWO_SIDED|95.0|-28.1|-3.3|||ANCOVA|||||-3.3|-28.1|0.01354
71026148|NCT01915732|141559423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5||||0.002|TWO_SIDED|95.0|-7.4|-1.6|||ANCOVA|||||-1.6|-7.4|0.002
71026149|NCT01915732|141559424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6|||<|0.001|TWO_SIDED|95.0|-7.3|-1.9|||ANCOVA|||||-1.9|-7.3|<0.001
71026150|NCT01915732|141559425|SUPERIORITY_OR_OTHER|||||||0.018|||||||Cochran-Mantel-Haenszel|||||||0.018
71026151|NCT01915732|141559426|SUPERIORITY_OR_OTHER|||||||0.013|||||||Cochran-Mantel-Haenszel|||||||0.013
71026152|NCT01915732|141559427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.077|TWO_SIDED|95.0|-1.8|0.1|||ANCOVA||Statistical data for the category=IL.|||0.1|-1.8|0.077
71026153|NCT01915732|141559427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.004|TWO_SIDED|95.0|-5.7|-1.1|||ANCOVA||Statistical data for the category=NIL.|||-1.1|-5.7|0.004
71026154|NCT01915732|141559428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.028|TWO_SIDED|95.0|-2.0|-0.1|||ANCOVA||Statistical data for the category=IL.|||-0.1|-2.0|0.028
71026155|NCT01915732|141559428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.002|TWO_SIDED|95.0|-5.5|-1.2|||ANCOVA||Statistical data for the category=NIL.|||-1.2|-5.5|0.002
71026156|NCT01915732|141559429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.08|TWO_SIDED|95.0|-0.06|0.0|||ANCOVA||Statistical data for the category=IL.|||0.00|-0.06|0.080
71026157|NCT01915732|141559429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.004|TWO_SIDED|95.0|-0.12|-0.02|||ANCOVA||Statistical data for the category=NIL.|||-0.02|-0.12|0.004
71026158|NCT01915732|141559429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.003|TWO_SIDED|95.0|-0.09|-0.02|||ANCOVA||Statisticial data for the category=Total.|||-0.02|-0.09|0.003
71026159|NCT01915732|141559430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.025|TWO_SIDED|95.0|-0.07|0.0|||ANCOVA||Statistical data for the category=IL.|||-0.00|-0.07|0.025
71026160|NCT01915732|141559430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|||<|0.001|TWO_SIDED|95.0|-0.14|-0.04|||ANCOVA||Statistical data for the category=NIL.|||-0.04|-0.14|<0.001
71026161|NCT01915732|141559430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|||<|0.001|TWO_SIDED|95.0|-0.1|-0.03|||ANCOVA||Statistical data for the category=Total.|||-0.03|-0.10|<0.001
71026162|NCT01915732|141559431|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71026163|NCT01915732|141559432|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71026164|NCT00494806|141559489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7279|STANDARD_ERROR_OF_MEAN|0.15|<|0.05||95.0|0.3174|1.1383|||t-test, 2 sided|df = 64|Relative risk not calculated.|"No differences in time to first flatus between the rocking and non rocking groups is the null hypothesis.~Sample size calculations by setting the criterion for significance at .05, two-tailed test (an effect in either directions was accepted), and power at .80. A total sample of 54 participants was determined necessary to yield statistically significant results (27 in Group A and 27 in Group B)."||1.1383|0.3174|<0.05
71026165|NCT00814320|141559493|SUPERIORITY_OR_OTHER_LEGACY||Poisson|0.025|||<|0.0001|ONE_SIDED|99.0||0.046||Testing the null hypothesis of 1 VASBI/year against a one-sided alternative at the 0.01 level of statistical significance.|Poisson|||For SC Administration of IGIV, 10%, with rHuPH20 after ramp-up, only||0.046||<0.0001
71026166|NCT00491504|141559559|SUPERIORITY_OR_OTHER_LEGACY|||||||0.625|||||||ANCOVA|An analysis of covariance (ANCOVA) model was used with treatment as effect and Baseline as a covariate.||||||0.625
71026167|NCT00745251|141559569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.86|STANDARD_ERROR_OF_MEAN|5.95||0.0084|ONE_SIDED|95.0||-4.84|||ANCOVA|||||-4.84||0.0084
71026168|NCT00745251|141559570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.05|STANDARD_ERROR_OF_MEAN|1.64||0.0006|TWO_SIDED|95.0|-9.37|-2.74|||ANCOVA|||||-2.74|-9.37|0.0006
71058988|NCT04194645|141624627|OTHER|The statistical model used for the analysis of the endpoint was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio of geometric mean (T2/R)|48.02|||||TWO_SIDED|90.0|41.86|55.09|||ANOVA||Intra- individual coefficient of variation (gCV %) = 18.5|No formal hypothesis was tested.||55.09|41.86|
71109215|NCT02163577|141723973|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
71058989|NCT04194645|141624627|OTHER|The statistical model used for the analysis of the endpoint was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio of geometric mean (T1/T2)|122.8|||||TWO_SIDED|90.0|105.04|143.56|||ANOVA||Intra- individual coefficient of variation (gCV %) = 19.8|No formal hypothesis was tested.||143.56|105.04|
71058990|NCT04194645|141624630|OTHER|The statistical model used for the analysis of the endpoint was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio of geometric mean (T2/R)|98.32|||||TWO_SIDED|90.0|91.98|105.09|||ANOVA||Intra- individual coefficient of variation (gCV %) = 8.9|No formal hypothesis was tested.||105.09|91.98|
71058991|NCT04194645|141624630|OTHER|The statistical model used for the analysis of the endpoint was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio of geometric mean (T1/T2)|112.94|||||TWO_SIDED|90.0|98.75|129.18|||ANOVA||Intra- individual coefficient of variation (gCV %) = 16.9|No formal hypothesis was tested.||129.18|98.75|
71058992|NCT01783886|141624631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.1|||<|0.0001|TWO_SIDED|97.5|10.9|17.2|||ANCOVA||Least Square (LS) mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||17.2|10.9|<0.0001
71058993|NCT01783886|141624631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.6|||<|0.0001|TWO_SIDED|97.5|10.2|16.9|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||16.9|10.2|<0.0001
71058994|NCT01783886|141624632|SUPERIORITY_OR_OTHER||CMH adjusted difference|47.4|||<|0.0001|TWO_SIDED|97.5|35.0|59.9|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel (CMH). The estimate is calculated as EYLEA minus Laser.|||59.9|35.0|<0.0001
71058995|NCT01783886|141624632|SUPERIORITY_OR_OTHER||CMH adjusted difference|39.2|||<|0.0001|TWO_SIDED|97.5|26.3|52.1|||Cochran-Mantel-Haenszel||The estimate is calculated as EYLEA minus Laser.|||52.1|26.3|<0.0001
71109216|NCT02163577|141723973|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71058996|NCT01783886|141624633|SUPERIORITY_OR_OTHER||CMH adjusted difference|31.1|||<|0.0001|TWO_SIDED|97.5|19.2|43.0|||Cochran-Mantel-Haenszel||The estimate is calculated as EYLEA minus Laser.|||43.0|19.2|<0.0001
71058997|NCT01783886|141624633|SUPERIORITY_OR_OTHER||CMH adjusted difference|24.3|||<|0.0001|TWO_SIDED|97.5|12.6|35.9|||Cochran-Mantel-Haenszel||The estimate is calculated as EYLEA minus Laser.|||35.9|12.6|<0.0001
71058998|NCT01783886|141624634|SUPERIORITY_OR_OTHER||CMH adjusted difference|39.1|||<|0.0001|TWO_SIDED|97.5|26.0|52.2|||Cochran-Mantel-Haenszel||The estimate is calculated as EYLEA minus Laser.|||52.2|26.0|<0.0001
71058999|NCT01783886|141624634|SUPERIORITY_OR_OTHER||CMH adjusted difference|40.6|||<|0.0001|TWO_SIDED|97.5|27.6|53.7|||Cochran-Mantel-Haenszel||The estimate is calculated as EYLEA minus Laser.|||53.7|27.6|<0.0001
71059000|NCT01783886|141624635|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-130.5|||<|0.0001|TWO_SIDED|97.5|-171.2|-89.9|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||-89.9|-171.2|<0.0001
71059001|NCT01783886|141624635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-131.4|||<|0.0001|TWO_SIDED|97.5|-172.8|-89.9|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||-89.9|-172.8|<0.0001
71109217|NCT02163577|141723973|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71109218|NCT02163577|141723974|SUPERIORITY|||||||0.0088|||||||one sample t-test|||Week 0 to Week 40||||0.0088
71109219|NCT02163577|141723974|SUPERIORITY|||||||0.465|||||||one sample t-test|||Week 0 to Week 40||||0.4650
71109220|NCT02163577|141723974|SUPERIORITY|||||||0.016|||||||one sample t test|||Week 0 to Week 64||||0.0160
71109221|NCT02163577|141723974|SUPERIORITY|||||||0.4114|||||||one sample t test|||Week 0 to Week 64||||0.4114
71109222|NCT02163577|141723974|SUPERIORITY|||||||0.5335|||||||one sample t test|||Week 64 to Week 112||||0.5335
71109223|NCT02163577|141723974|SUPERIORITY|||||||0.8606|||||||one sample t test|||Week 64 to Week 112||||0.8606
71109224|NCT02163577|141723974|SUPERIORITY|||||||0.1627|||||||one sample t test|||Week 112 to Week 160||||0.1627
71059002|NCT01783886|141624636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.78||||0.0364|TWO_SIDED|97.5|-0.41|11.97|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||11.97|-0.41|0.0364
71059003|NCT01783886|141624636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.87||||0.0113|TWO_SIDED|97.5|0.8|12.94|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||12.94|0.80|0.0113
71059004|NCT01783886|141624637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.81||||0.2688|TWO_SIDED|97.5|-2.9|8.53|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||8.53|-2.90|0.2688
71109225|NCT02163577|141723974|SUPERIORITY|||||||0.4096|||||||one sample t test|||Week 112 to Week 160||||0.4096
71109226|NCT02163577|141723975|SUPERIORITY||||||<|0.0001||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
71109227|NCT02163577|141723975|SUPERIORITY|||||||0.0569||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 40||||0.0569
71109228|NCT02163577|141723975|SUPERIORITY|||||||0.0002||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 64||||0.0002
71026169|NCT00717977|141559571|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||Adjusted for CGM device type. Age was analyzed as continuous.|Regression, Linear|||The associations of mean sensor glucose and glucose variability measures with age were assessed using least-squares regression models adjusting for device type.||||0.009
71026170|NCT00717977|141559572|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||Adjusted for CGM device type. Age was analyzed as continuous.|Regression, Linear|||The associations of mean sensor glucose and glucose variability measures with age were assessed using least-squares regression models adjusting for device type.||||0.04
71026171|NCT00717977|141559573|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Adjusted for device type. Age was analyzed as continuous.|Regression, Linear|||The associations of mean sensor glucose and glucose variability measures with age were assessed using least-squares regression models adjusting for device type.||||<0.001
71026172|NCT02232074|141559655|SUPERIORITY||Odds Ratio (OR)|0.82||||0.77|TWO_SIDED|95.0|0.21|3.14||a priori threshold for statistical significance p\<0.05|Regression, Logistic|||Compared to the control group, the Breast cancer INTERVENTION group will be more likely to have timely first treatment (i.e. receipt of first treatment within 90 days of diagnosis).||3.14|0.21|0.77
71026173|NCT02232074|141559656|SUPERIORITY||Odds Ratio (OR)|4.0||||0.26|TWO_SIDED|95.0|0.35|45.4||a priori threshold for statistical significance p\<0.05|Regression, Logistic|||Compared to the control group, the Lung cancer INTERVENTION group will be more likely to have timely first treatment (i.e. receipt of first treatment within 90 days of diagnosis).||45.4|0.35|0.26
71026174|NCT02232074|141559657|SUPERIORITY||Median Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.42||0.53|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|Adjusting for baseline Distress Thermometer scores.||Compared to the control group, the Breast cancer INTERVENTION group will have less distress at 3 months post-enrollment||||0.53
71026175|NCT02232074|141559658|SUPERIORITY||Median Difference (Final Values)|-1.32|STANDARD_ERROR_OF_MEAN|1.62||0.43|TWO_SIDED|||||Adjusting for baseline Distress Thermometer scores.|Regression, Linear|||Compared to the control group, the LUNG cancer INTERVENTION group will have less distress at 3 months post-enrollment||||0.43
71026176|NCT02232074|141559659|SUPERIORITY||Median Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.45||0.18|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|Adjusting for baseline Distress Thermometer scores.||Compared to the control group, the Breast cancer INTERVENTION group will have less distress at 6 months post-enrollment||||0.18
71026177|NCT02232074|141559660|SUPERIORITY||Median Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|1.29||0.33|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|Adjusting for baseline Distress Thermometer scores.||Compared to the control group, the Lung cancer INTERVENTION group will have less distress at 6 months post-enrollment||||0.33
71026178|NCT02232074|141559661|SUPERIORITY||Median Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.07||0.68|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.68
71026179|NCT02232074|141559662|SUPERIORITY||Median Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.15||0.26|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.26
71026180|NCT02232074|141559663|SUPERIORITY||Median Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|1.43||0.62|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||Compared to the control group, the Breast cancer INTERVENTION group will be more satisfied with patient navigation at 6 months post-enrollment||||0.62
71026181|NCT02232074|141559664|SUPERIORITY||Median Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|2.91||0.69|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||Compared to the control group, the Lung cancer INTERVENTION group will be more satisfied with patient navigation at 6 months post-enrollment||||0.69
71026182|NCT02232074|141559665|SUPERIORITY||Median Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.59||0.58|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|adjusting for baseline Case scores.||Compared to the control group, the breast cancer INTERVENTION group would have higher self-efficacy was adjusting for baseline self-efficacy scores.||||0.58
71026183|NCT02232074|141559666|SUPERIORITY||Median Difference (Final Values)|4.2|STANDARD_ERROR_OF_MEAN|2.21||0.09|TWO_SIDED||||||Regression, Linear|adjusting for baseline Case scores.||Compared to the control group, the lung cancer INTERVENTION group would have higher self-efficacy was adjusting for baseline self-efficacy scores.||||0.09
71026184|NCT02232074|141559667|SUPERIORITY||Odds Ratio (OR)|0.85||||0.79|TWO_SIDED|95.0|0.28|2.79||a priori threshold for statistical significance p\<0.05|Regression, Logistic|||We hypothesize that compared to the control group, the Breast cancer INTERVENTION group will receive quality care (i.e. receipt of radiation within one year of diagnosis).||2.79|0.28|0.79
71026185|NCT02232074|141559668|SUPERIORITY||Median Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.5||0.71|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||We hypothesize that compared to the control group, the Breast cancer INTERVENTION group will have less distress at 12 months post-enrollment.||||0.71
71026186|NCT02232074|141559669|SUPERIORITY||Median Difference (Final Values)|-1.45|STANDARD_DEVIATION|2.71||0.61|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||We hypothesize that compared to the control group, the Lung cancer INTERVENTION group will have less distress at 12 months post-enrollment||||0.61
71059005|NCT01783886|141624637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.01||||0.0009|TWO_SIDED|97.5|2.64|13.37|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||13.37|2.64|0.0009
71059006|NCT04542057|141624638|SUPERIORITY||LS mean difference|0.0941|STANDARD_ERROR_OF_MEAN|0.01501|<|0.0001|TWO_SIDED|95.0|0.0647|0.1236||The analysis of covariance (ANCOVA) model was used to model the change from baseline FEV1 to average FEV1 AUC0-12h with treatment, region, background medication strata and smoking strata as fixed effects and baseline FEV1 as covariate.|ANCOVA|||||0.1236|0.0647|<0.0001
71059007|NCT00825786|141624726|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.14|TWO_SIDED|95.0|0.46|1.09|||Log Rank||group 2 vs. group 1 (sequential vs combined)|||1.09|0.46|0.14
71059008|NCT00825786|141624727|SUPERIORITY|||||||0.02|||||||Log Rank|||||||0.02
71059009|NCT00825786|141624728|SUPERIORITY|||||||0.66|||||||Log Rank|||||||0.66
71059010|NCT00825786|141624729|SUPERIORITY|||||||0.6|||||||ANCOVA|||||||0.60
71059011|NCT00825786|141624730|SUPERIORITY|||||||0.34|||||||ANCOVA|||||||0.34
71059012|NCT00825786|141624731|SUPERIORITY|||||||0.15|||||||Log Rank|||||||0.15
71109229|NCT02163577|141723975|SUPERIORITY|||||||0.0456||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 64||||0.0456
71109230|NCT02163577|141723975|SUPERIORITY||||||<|0.0001||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71109231|NCT02163577|141723975|SUPERIORITY|||||||0.0343||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 160||||0.0343
71059013|NCT00825786|141624732|SUPERIORITY|||||||0.88|||||||ANCOVA|||||||0.88
71059014|NCT01277211|141624733|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Pearl Indices|0.61||||0.531|TWO_SIDED|95.0|0.19|2.29|||Poisson distribution method|Differences between treatment groups was explored using an exact 95% CI for the ratio of the two Pearl Indices based on the Poisson distribution.||Differences between the two treatment groups (ENG-EE vs. DRSP-EE) were explored using an exact 95% CI for the Ratio of the two Pearl Indices based on the Poisson distribution.||2.29|0.19|0.531
71059015|NCT01277211|141624734|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 1|-3.0||||0.346|TWO_SIDED|95.0|-9.9|3.1|||Miettinen and Nurminen method|||For Cycle 1, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||3.1|-9.9|0.346
71059016|NCT01277211|141624734|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 2|-6.2||||0.029|TWO_SIDED|95.0|-12.7|-0.6|||Miettinen and Nurminen method|||For Cycle 2, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.6|-12.7|0.029
71059017|NCT01277211|141624734|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 3|-5.8||||0.019|TWO_SIDED|95.0|-11.8|-0.9|||Miettinen and Nurminen method|||For Cycle 3, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.9|-11.8|0.019
71109232|NCT02163577|141723980|SUPERIORITY|||||||0.0771||||||GEE model included change in 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.0771
71109233|NCT02163577|141723980|SUPERIORITY|||||||0.9098||||||GEE model included change in 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.9098
71059018|NCT01277211|141624734|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 4|-8.0||||0.001|TWO_SIDED|95.0|-14.0|-2.9|||Miettinen and Nurminen method|||For Cycle 4, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-2.9|-14.0|0.001
71059019|NCT01277211|141624734|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 5|-1.3||||0.556|TWO_SIDED|95.0|-6.4|2.6|||Miettinen and Nurminen method|||For Cycle 5, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||2.6|-6.4|0.556
71059020|NCT01277211|141624734|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 6|-3.9||||0.089|TWO_SIDED|95.0|-9.5|0.5|||Miettinen and Nurminen method|||For Cycle 6, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||0.5|-9.5|0.089
71059021|NCT01277211|141624734|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 7|-3.7||||0.11|TWO_SIDED|95.0|-9.4|0.8|||Miettinen and Nurminen method|||For Cycle 7, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||0.8|-9.4|0.110
71059022|NCT01277211|141624734|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 8|-4.3||||0.049|TWO_SIDED|95.0|-9.8|0.0|||Miettinen and Nurminen method|||For Cycle 8, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.0|-9.8|0.049
71059023|NCT01277211|141624734|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 9|-1.1||||0.621|TWO_SIDED|95.0|-6.2|2.9|||Miettinen and Nurminen method|||For Cycle 9, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||2.9|-6.2|0.621
71059024|NCT01277211|141624734|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 10|-4.4||||0.041|TWO_SIDED|95.0|-10.0|-0.2|||Miettinen and Nurminen method|||For Cycle 10, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.2|-10.0|0.041
71109234|NCT02163577|141723980|SUPERIORITY|||||||0.0007||||||GEE model included change in percent of predicted 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0007
71059025|NCT01277211|141624734|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 11|-3.8||||0.046|TWO_SIDED|95.0|-8.9|-0.1|||Miettinen and Nurminen method|||For Cycle 11, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.1|-8.9|0.046
71059026|NCT01277211|141624734|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 12|-4.4||||0.037|TWO_SIDED|95.0|-9.9|-0.2|||Miettinen and Nurminen method|||For Cycle 12, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.2|-9.9|0.037
71059027|NCT01277211|141624734|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 13|-4.5||||0.048|TWO_SIDED|95.0|-10.4|0.0|||Miettinen and Nurminen method|||For Cycle 13, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.0|-10.4|0.048
71059028|NCT01277211|141624735|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 1|-6.0||||0.015|TWO_SIDED|95.0|-12.0|-1.1|||Miettinen and Nurminen method|||For Cycle 1, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-1.1|-12.0|0.015
71059029|NCT01277211|141624735|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 2|-4.9||||0.012|TWO_SIDED|95.0|-10.1|-1.0|||Miettinen and Nurminen method|||For Cycle 2, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-1.0|-10.1|0.012
71059030|NCT01277211|141624735|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 3|-6.5||||0.002|TWO_SIDED|95.0|-12.0|-2.2|||Miettinen and Nurminen method|||For Cycle 3, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-2.2|-12.0|0.002
71109235|NCT02163577|141723980|SUPERIORITY|||||||0.0327||||||GEE model included change in percent of predicted 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0327
71109236|NCT02163577|141723980|SUPERIORITY|||||||0.1865||||||GEE model included change in percent of predicted 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||0.1865
71059031|NCT01277211|141624735|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 4|-3.6||||0.044|TWO_SIDED|95.0|-8.5|-0.1|||Miettinen and Nurminen method|||For Cycle 4, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.1|-8.5|0.044
71059032|NCT01277211|141624735|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 5|-1.0||||0.609|TWO_SIDED|95.0|-5.7|2.5|||Miettinen and Nurminen method|||For Cycle 5, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||2.5|-5.7|0.609
71059033|NCT01277211|141624735|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 6|-3.9||||0.062|TWO_SIDED|95.0|-9.3|0.2|||Miettinen and Nurminen method|||For Cycle 6, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||0.2|-9.3|0.062
71059034|NCT01277211|141624735|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 7|-4.1||||0.019|TWO_SIDED|95.0|-9.0|-0.6|||Miettinen and Nurminen method|||For Cycle 7, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.6|-9.0|0.019
71059035|NCT01277211|141624735|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 8|-1.9||||0.308|TWO_SIDED|95.0|-6.7|1.6|||Miettinen and Nurminen method|||For Cycle 8, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||1.6|-6.7|0.308
71059036|NCT01277211|141624735|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 9|-4.2||||0.027|TWO_SIDED|95.0|-9.3|-0.4|||Miettinen and Nurminen method|||For Cycle 9, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.4|-9.3|0.027
71059037|NCT01277211|141624735|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 10|-2.9||||0.098|TWO_SIDED|95.0|-7.6|0.5|||Miettinen and Nurminen method|||For Cycle 10, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||0.5|-7.6|0.098
71059038|NCT01277211|141624735|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 11|-4.4||||0.009|TWO_SIDED|95.0|-9.4|-1.0|||Miettinen and Nurminen method|||For Cycle 11, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-1.0|-9.4|0.009
71109237|NCT02163577|141723980|SUPERIORITY|||||||0.2654||||||GEE model included change in percent of predicted 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||0.2654
71059039|NCT01277211|141624735|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 12|-6.2||||0.002|TWO_SIDED|95.0|-11.7|-2.1|||Miettinen and Nurminen method|||For Cycle 12, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-2.1|-11.7|0.002
71059040|NCT01277211|141624735|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 13|-4.5||||0.043|TWO_SIDED|95.0|-10.2|-0.1|||Miettinen and Nurminen method|||For Cycle 13, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.1|-10.2|0.043
71059041|NCT00770328|141624736|SUPERIORITY|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||||||0.0005
71059042|NCT00770328|141624737|SUPERIORITY|||||||0.0114|||||||Wilcoxon (Mann-Whitney)|||||||0.0114
71059043|NCT03452943|141624745|OTHER||LS mean difference|-0.7||||0.692|TWO_SIDED|95.0|-4.1|2.8||Threshold for significance at 0.05 level.|Mixed Models Analysis|||||2.8|-4.1|0.692
71109238|NCT02163577|141723981|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
71026187|NCT02232074|141559670|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_DEVIATION|0.08||0.46|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.46
71026188|NCT02232074|141559671|SUPERIORITY||Median Difference (Final Values)|-0.03|STANDARD_DEVIATION|0.2||0.89|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.89
71026189|NCT02232074|141559672|SUPERIORITY||Mean Difference (Final Values)|2.38|STANDARD_DEVIATION|1.66||0.16|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.16
71059044|NCT00879086|141624758|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|-16.7|||=|0.0941|TWO_SIDED|95.0|-36.1|2.4||The two treatment groups were compared, controlling for baseline pre-existing neuropathy (CTCAE Grade 0 or 1) and number of prior chemotherapy regimens (less than or equal to 3 or greater than 3), with both covariates included as binary variables.|Cochran-Mantel-Haenszel||Extended Mantel-Haenszel test statistics with stratification adjustment for pre-existing baseline neuropathy (CTCAE Grade 0 or 1) and number of prior chemotherapy regimens (greater than or equal to 3 or greater than 3)|||2.4|-36.1|=0.0941
71059045|NCT00879086|141624759|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|-18.4||||0.0492|TWO_SIDED|95.0|-36.0|-0.3||Controlled for baseline pre-existing neuropathy (CTCAE Grade 0 or 1) and number of prior chemotherapy regimens (greater than or equal to 3 or greater than 3), with both covariates included as binary variables.|Cochran-Mantel-Haenszel||Extended Mantel-Haenszel test statistics with stratification adjustment for pre-existing baseline neuropathy (CTCAE Grade 0 or 1) and number of prior chemotherapy regimens (greater than or equal to 3 or greater than 3)|||-0.3|-36.0|0.0492
71109239|NCT02163577|141723981|SUPERIORITY|||||||0.0144||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.0144
71109240|NCT02163577|141723981|SUPERIORITY|||||||0.0384||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0384
71109241|NCT02163577|141723981|SUPERIORITY|||||||0.0004||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0004
71026190|NCT02232074|141559673|SUPERIORITY||Mean Difference (Final Values)|-4.83|STANDARD_DEVIATION|2.93||0.16|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.16
71026191|NCT02232074|141559674|SUPERIORITY||Mean Difference (Final Values)|1.14|STANDARD_DEVIATION|0.75||0.13|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.13
71059046|NCT02593110|141624802|SUPERIORITY||Mean Difference (Final Values)|-24.41||||0.1107|TWO_SIDED|95.0|-54.59|5.78|||ANCOVA|||||5.78|-54.59|0.1107
71059047|NCT02593110|141624802|SUPERIORITY||Mean Difference (Final Values)|9.78||||0.5378|TWO_SIDED|95.0|-21.84|41.39|||ANCOVA|||||41.39|-21.84|0.5378
71109242|NCT02163577|141723981|SUPERIORITY|||||||0.9795||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||0.9795
71026192|NCT02232074|141559675|SUPERIORITY||Mean Difference (Final Values)|0.97|STANDARD_DEVIATION|3.7||0.8|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.80
71026193|NCT02688400|141559725|NON_INFERIORITY|"Non-inferiority of Diacerein versus Celecoxib was assessed by computing the difference in the adjusted mean change from baseline (Visit 2) in WOMAC Pain subscale score after 182 days of treatment between Diacerein and Celecoxib treatment groups from a MMRM.~Assuming that:~* Non inferiority margin of 10 points for the absolute change in WOMAC Pain Subscale Score (scale 0-100)~* SD of 26 in the two treatment groups,~* Type I error: α = 0.025 (one-sided condition) and power equal to 90%"|Mean Difference (Final Values)|0.67|||<|0.025|ONE_SIDED|95.0||3.18||MMRM. Non-inferiority claim:Diacerein to be non-inferior to Celecoxib if upper bound of the the difference in the adjusted mean change was inferior to 5 cm on the PPS.|Mixed Models Analysis|||||3.18||<0.025
71059048|NCT02593110|141624802|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.956|TWO_SIDED|95.0|-24.96|26.38|||ANCOVA|||||26.38|-24.96|0.9560
71109243|NCT02163577|141723981|SUPERIORITY|||||||0.2082||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||0.2082
71109244|NCT02163577|141723982|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
71026194|NCT02688400|141559726|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
71059049|NCT02593110|141624803|SUPERIORITY||Mean Difference (Final Values)|31.35||||0.6121|TWO_SIDED|95.0|-92.42|155.12|||ANCOVA|||||155.12|-92.42|0.6121
71059050|NCT02593110|141624803|SUPERIORITY||Mean Difference (Final Values)|141.78||||0.0116|TWO_SIDED|95.0|33.14|250.42|||ANCOVA|||||250.42|33.14|0.0116
70941716|NCT04748445|141383935|OTHER||Slope|-0.0002606|STANDARD_ERROR_OF_MEAN|9.707||0.7888|TWO_SIDED|90.0|-0.001869|0.001348|||Mixed Models Analysis|||EE\_MFCC 1st order delta 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001348|-0.001869|0.7888
71026195|NCT02688400|141559727|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
71059051|NCT02593110|141624803|SUPERIORITY||Mean Difference (Final Values)|-14.75||||0.8146|TWO_SIDED|95.0|-140.89|111.39|||ANCOVA|||||111.39|-140.89|0.8146
71026196|NCT02688400|141559728|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
71026197|NCT02688400|141559729|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Chi-squared|||||||0.05
71026198|NCT02688400|141559730|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Chi-squared|||||||0.05
71026199|NCT02688400|141559731|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
71026200|NCT02688400|141559732|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
71026201|NCT02688400|141559733|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
71059052|NCT02593110|141624804|SUPERIORITY||Mean Difference (Final Values)|0.92||||0.8755|TWO_SIDED|95.0|-10.84|12.68|||ANCOVA|||||12.68|-10.84|0.8755
71059053|NCT02593110|141624804|SUPERIORITY||Mean Difference (Final Values)|2.44||||0.7651|TWO_SIDED|95.0|-13.83|18.7|||ANCOVA|||||18.70|-13.83|0.7651
71059054|NCT02593110|141624804|SUPERIORITY||Mean Difference (Final Values)|6.88||||0.3776|TWO_SIDED|95.0|-8.65|22.41|||ANCOVA|||||22.41|-8.65|0.3776
71059055|NCT02593110|141624805|SUPERIORITY||Mean Difference (Final Values)|-8.06||||0.1782|TWO_SIDED|95.0|-19.91|3.79|||ANCOVA|||||3.79|-19.91|0.1782
71059056|NCT02593110|141624805|SUPERIORITY||Mean Difference (Final Values)|-5.27||||0.3555|TWO_SIDED|95.0|-16.61|6.07|||ANCOVA|||||6.07|-16.61|0.3555
71059057|NCT02593110|141624805|SUPERIORITY||Mean Difference (Final Values)|5.75||||0.3294|TWO_SIDED|95.0|-5.99|17.49|||ANCOVA|||||17.49|-5.99|0.3294
71059058|NCT02593110|141624806|SUPERIORITY||Mean Difference (Final Values)|-8.72||||0.1569|TWO_SIDED|95.0|-20.91|3.47|||ANCOVA|||||3.47|-20.91|0.1569
71059059|NCT02593110|141624806|SUPERIORITY||Mean Difference (Final Values)|-2.07||||0.7692|TWO_SIDED|95.0|-16.16|12.02|||ANCOVA|||||12.02|-16.16|0.7692
71059060|NCT02593110|141624806|SUPERIORITY||Mean Difference (Final Values)|3.09||||0.6306|TWO_SIDED|95.0|-9.74|15.91|||ANCOVA|||||15.91|-9.74|0.6306
71059061|NCT02593110|141624807|SUPERIORITY||Mean Difference (Final Values)|-7.86||||0.3542|TWO_SIDED|95.0|-24.74|9.02|||ANCOVA|||||9.02|-24.74|0.3542
71059062|NCT02593110|141624807|SUPERIORITY||Mean Difference (Final Values)|-0.64||||0.9417|TWO_SIDED|95.0|-17.98|16.71|||ANCOVA|||||16.71|-17.98|0.9417
71059063|NCT02593110|141624807|SUPERIORITY||Mean Difference (Final Values)|5.45||||0.4508|TWO_SIDED|95.0|-8.96|19.86|||ANCOVA|||||19.86|-8.96|0.4508
71109245|NCT02163577|141723982|SUPERIORITY|||||||0.0251||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.0251
70935447|NCT03964974|141371901|SUPERIORITY|2-sided hypothesis tests were utilized to compare ISI score over time in the two treatment conditions.|Median Difference (Final Values)|-4.307|STANDARD_ERROR_OF_MEAN|1.612||0.0041|TWO_SIDED|95.0|-7.51|-1.104||This is the calculated p-value. The threshold for statistical significance was 0.05.|Mixed Models Analysis|||Persons in the CBTI-CB condition were hypothesized as realizing greater reduction in insomnia severity as measured by the Insomnia Severity Index (ISI) over time compared to the Sleep Hygiene Education (SHE) condition. 80% power was estimated to detect a medium or larger effect size (d\>0.52) on sleep- and functioning-related outcomes, even with a more conservative alpha set at 0.017 (i.e., 0.05/3 for the 3 outcomes).|Parameter is estimated difference in final means, CBTi-CB - Control. Minus sign denotes greater decrease for CBTi-CB. Effect size for Time X Condition = 0.81|-1.104|-7.510|0.0041
70935448|NCT02746107|141371921|NON_INFERIORITY_OR_EQUIVALENCE|details provided in the protocol. Noninferiority margin=+/-5%|Risk Difference (RD)|0.5||||0.83|TWO_SIDED|95.0|-4.0|5.4|||Chi-squared|||||5.4|-4|0.83
70935449|NCT02746107|141371922|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.4||||0.187|TWO_SIDED|95.0|-1.3|8.1|||Chi-squared||(risk on 5y) - (risk on 1y)|details provided in protocol;||8.1|-1.3|0.187
71059064|NCT04604795|141624828|OTHER||Ratio of geometric mean|1.05|||||TWO_SIDED|90.0|0.833|1.331|||||Log transformed Cmax was analyzed using a mixed model with fixed effects for regimen and period, and participants as random effect.|||1.331|0.833|
71059065|NCT04604795|141624828|OTHER||Ratio of geometric mean|6.45|||||TWO_SIDED|90.0|4.916|8.474|||||Log transformed Cmax was analyzed using a mixed model with regimen, period, and regimen by period as fixed effects and participants as random effect.|||8.474|4.916|
71059066|NCT04604795|141624837|OTHER||Ratio of geometric mean|1.53|||||TWO_SIDED|90.0|1.268|1.847|||||AUC(0-inf) was analyzed using a mixed model with fixed effects for regimen and period, and participants as random effect.|||1.847|1.268|
71109246|NCT02163577|141723982|SUPERIORITY|||||||0.9124||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.9124
71059067|NCT04604795|141624837|OTHER||Ratio of geometric mean|12.51|||||TWO_SIDED|90.0|10.141|15.423|||||Log transformed AUC(0-inf) was analyzed using a mixed model with regimen, period, and regimen by period as fixed effects and participants as random effect.|||15.423|10.141|
71059068|NCT04604795|141624874|OTHER||Ratio of geometric mean|0.47|||||TWO_SIDED|90.0|0.318|0.693|||||Day 5 (High fat meal) versus (vs) Day 3 (fasted)|||0.693|0.318|
71059069|NCT04604795|141624874|OTHER||Ratio of geometric mean|0.6|||||TWO_SIDED|90.0|0.405|0.882|||||Day 7 (Standard meal) vs Day 3 (fasted)|||0.882|0.405|
71059070|NCT04604795|141624874|OTHER||Ratio of geometric mean|0.29|||||TWO_SIDED|90.0|0.194|0.427|||||Day 5 (High fat meal) vs Day 3 (fasted)|||0.427|0.194|
70935450|NCT02746107|141371923|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.4|||<|0.001|TWO_SIDED|95.0|10.8|20.0|||Chi-squared||patient - (physicians themselves)|||20|10.8|<0.001
70935451|NCT02746107|141371923|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.28|||<|0.001|TWO_SIDED|95.0|2.25|4.78|||Regression, Logistic|adjustment for age, gender, CHA2D2s-VASC score, nr of diagrams, nr of years, presence of someone close with stroke, graduation year, speciality||||4.78|2.25|<0.001
71059071|NCT04604795|141624874|OTHER||Ratio of geometric mean|0.43|||||TWO_SIDED|90.0|0.292|0.643|||||Day 7 (Standard meal) vs Day 3 (fasted)|||0.643|0.292|
71059072|NCT04604795|141624874|OTHER||Ratio of geometric mean|0.42|||||TWO_SIDED|90.0|0.28|0.617|||||Day 5 (High fat meal) vs Day 3 (fasted)|||0.617|0.280|
71059073|NCT04604795|141624874|OTHER||Ratio of geometric mean|0.61|||||TWO_SIDED|90.0|0.41|0.903|||||Day 7 (Standard meal) vs Day 3 (fasted)|||0.903|0.410|
71059074|NCT04604795|141624876|OTHER||Ratio of geometric mean|1.02|||||TWO_SIDED|90.0|0.867|1.205|||||Day 5 (High fat meal) vs Day 3 (fasted)|||1.205|0.867|
71059075|NCT04604795|141624876|OTHER||Ratio of geometric mean|1.11|||||TWO_SIDED|90.0|0.941|1.308|||||Day 7 (Standard meal) vs Day 3 (fasted)|||1.308|0.941|
71059076|NCT04604795|141624876|OTHER||Ratio of geometric mean|0.79|||||TWO_SIDED|90.0|0.671|0.933|||||Day 5 (High fat meal) vs Day 3 (fasted)|||0.933|0.671|
71059077|NCT04604795|141624876|OTHER||Ratio of geometric mean|0.85|||||TWO_SIDED|90.0|0.724|1.007|||||Day 7 (Standard meal) vs Day 3 (fasted)|||1.007|0.724|
71059078|NCT04604795|141624876|OTHER||Ratio of geometric mean|0.84|||||TWO_SIDED|90.0|0.713|0.992|||||Day 5 (High fat meal) vs Day 3 (fasted)|||0.992|0.713|
71059079|NCT04604795|141624876|OTHER||Ratio of geometric mean|0.99|||||TWO_SIDED|90.0|0.837|1.165|||||Day 7 (Standard meal) vs Day 3 (fasted)|||1.165|0.837|
71059080|NCT00719186|141624894|SUPERIORITY_OR_OTHER|||||||0.007|||||||Chi-squared|||||||0.007
70935452|NCT02746107|141371924|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.3||||0.034|TWO_SIDED|95.0|1.2|17.0|||Chi-squared|CHA2D2S-VASC risk score 1 was reference|positive value means higher proportion of prescription, CHA2D2S-VASC risk score 1 was reference|CHA2D2S-VASC risk score 1 was the reference||17|1.2|0.034
70935453|NCT02746107|141371924|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.2||||0.033|TWO_SIDED|95.0|1.2|17.0|||Chi-squared|||||17|1.2|0.033
70935454|NCT02746107|141371924|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.4||||0.003|TWO_SIDED|95.0|4.7|20.1|||Chi-squared|||||20.1|4.7|0.003
70935455|NCT02746107|141371924|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.1||||0.009|TWO_SIDED|95.0|3.2|18.8|||Chi-squared|||||18.8|3.2|0.009
70935456|NCT02746107|141371924|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.82||||0.024|TWO_SIDED|95.0|1.08|3.07|||Regression, Logistic|CHA2D2S-VASC risk score 1 was the reference, adjusted for nr diagrams, nr years, age, gender, smb close with stroke, speciality, professional degree||CHA2D2S-VASC risk score 1 was the reference||3.07|1.08|0.024
70935457|NCT02746107|141371924|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77||||0.03|TWO_SIDED|95.0|1.06|2.98|||Regression, Logistic|Adjusted for age, gender, medical and academic degrees, someone close with stroke, speciality, period of risk estimation, number of figures.|numerator: CHADS-VASC 1|||2.98|1.06|0.03
70935458|NCT02746107|141371924|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.37||||0.002|TWO_SIDED|95.0|1.37|4.09|||Regression, Logistic|Adjusted for age, gender, medical and academic degrees, someone close with stroke, speciality, period of risk estimation, number of figures.|numerator = CHADS-VASC 1|||4.09|1.37|0.002
70935459|NCT02746107|141371924|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.004|TWO_SIDED|95.0|1.14|2.56|||Regression, Logistic|Adjusted for age, gender, medical and academic degrees, someone close with stroke, speciality, period of risk estimation, number of figures.|numerator=CHADS-VASC 1|||2.56|1.14|0.004
70935460|NCT01332266|141371945|SUPERIORITY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.54|1.46||||||||1.46|0.54|
70935461|NCT01332266|141371947|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.61|1.73||||||||1.73|0.61|
70935462|NCT01332266|141371948|SUPERIORITY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.53|1.37||||||||1.37|0.53|
70935463|NCT03302091|141371950|OTHER||Adjusted gMean ratio (T/R)%|198.5|STANDARD_DEVIATION|96.5|||TWO_SIDED|90.0|101.83|386.94|||ANOVA||Standard deviation is actually intra individual geometric coefficient of variation (%).|"The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect degree of renal impairment as a fixed effect as well as subject pair as a random effect."||386.94|101.83|
70935464|NCT03302091|141371951|OTHER||Adjusted gMean ratio (T/R)%|198.42|STANDARD_DEVIATION|77.5|||TWO_SIDED|90.0|116.56|337.78|||ANOVA||Standard deviation is actually intra individual geometric coefficient of variation (%).|"The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect degree of renal impairment as a fixed effect as well as subject pair as a random effect."||337.78|116.56|
70935465|NCT03302091|141371952|OTHER||Adjusted gMean ratio (T/R)%|226.29|STANDARD_DEVIATION|47.5|||TWO_SIDED|90.0|156.35|327.53|||ANOVA||Standard deviation is actually intra individual geometric coefficient of variation (%).|"The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect degree of renal impairment as a fixed effect as well as subject pair as a random effect."||327.53|156.35|
70935466|NCT03302091|141371953|OTHER||Adjusted gMean ratio (T/R)%|140.4|STANDARD_DEVIATION|32.8|||TWO_SIDED|90.0|108.06|182.43|||ANOVA||Standard deviation is actually intra individual geometric coefficient of variation (%).|"The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect degree of renal impairment as a fixed effect as well as subject pair as a random effect."||182.43|108.06|
70935467|NCT03302091|141371954|OTHER||Adjusted gMean ratio (T/R)%|165.63|STANDARD_DEVIATION|56.6|||TWO_SIDED|90.0|107.51|255.17|||ANOVA||Standard deviation is actually intra individual geometric coefficient of variation (%).|"The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect degree of renal impairment as a fixed effect as well as subject pair as a random effect."||255.17|107.51|
70935468|NCT03302091|141371955|OTHER||Adjusted gMean ratio (T/R)%|128.44|STANDARD_DEVIATION|31.7|||TWO_SIDED|90.0|99.64|165.57|||ANOVA||Standard deviation is actually intra individual geometric coefficient of variation (%).|"The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect degree of renal impairment as a fixed effect as well as subject pair as a random effect."||165.57|99.64|
70935469|NCT02224755|141371963|NON_INFERIORITY|Non-inferiority would be demonstrated if the 95% lower confidence boundary for the difference between treatment groups (HM3 - HMII) in the occurrence of the primary end point would be greater than -10 percentage points, at a one-sided alpha level of 0.025 or a two-tailed P value of less than 0.05.|Risk Difference (RD)|9.4|||<|0.001|ONE_SIDED|95.0|-2.1||||Farrington-Manning risk difference||||||-2.1|<0.001
70935470|NCT02224755|141371964|NON_INFERIORITY|Non-inferiority would be demonstrated if the 95% lower confidence boundary for the difference between treatment groups (HM3 - HMII) in the occurrence of the primary end point would be greater than -10 percentage points, at a one-sided alpha level of 0.025 or a two-tailed P value of less than 0.05.|Risk Difference (RD)|19.2|||<|0.001|ONE_SIDED|95.0|9.8||||Farrington-Manning risk difference||||||9.8|<0.001
70935471|NCT02224755|141371965|SUPERIORITY||Risk Ratio (RR)|0.21|||<|0.001|TWO_SIDED|95.0|0.11|0.38|||Fisher Exact|||Based on data in the Sponsor's device tracking database, 7% of patients with the HeartMate II LVAS receive a pump replacement by 24 months. The expected proportion of patients with the HeartMate 3 LVAS to receive a pump replacement by 24 months was assumed to be 3%. We estimated that to demonstrate superiority of HeartMate 3 to HeartMate II with a power of 80% and α = 0.05 (2-sided), a total of 1028 patients (514 per arm) were required using the Fisher's exact test.||.38|.11|<0.001
70935472|NCT01482091|141372001|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon (Mann-Whitney)|||||||0.048
70935473|NCT01482091|141372003|SUPERIORITY_OR_OTHER||||||=|0.05|||||||Fisher Exact|||||||=0.05
70935474|NCT01482091|141372004|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
70935475|NCT01482091|141372007|SUPERIORITY_OR_OTHER||||||=|0.68|||||||t-test, 2 sided|||||||=0.68
70935476|NCT01482091|141372008|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71059081|NCT02096744|141624902|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means Catapres-TTS-3(Oppanol/Vistanex) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|102.33|STANDARD_ERROR_OF_MEAN|19.0|<|0.0001|TWO_SIDED|90.0|95.74|109.37|||ANOVA|ANOVA on the logarithmic scale including effects for 'Group', 'sequence', 'subjects within sequences', 'period', and 'treatment'.|"The estimated value is actually the ratio of Catapres-TTS-3 with Oppanol and Catapres-TTS-3 with Vistanex.~The value in parameter dispersion type and dispersion value is actually the intra-individual gCV."|||109.37|95.74|<0.0001
71059082|NCT02096744|141624903|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means Catapres-TTS-3(Oppanol/Vistanex) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|104.25|STANDARD_ERROR_OF_MEAN|16.6|<|0.0001|TWO_SIDED|90.0|98.367|110.487|||ANOVA|ANOVA on the logarithmic scale including effects for 'Group', 'sequence', 'subjects within sequences', 'period', and 'treatment'.|"The estimated value is actually the ratio of Catapres-TTS-3 with Oppanol and Catapres-TTS-3 with Vistanex.~The value in parameter dispersion type and dispersion value is actually the intra-individual gCV."|||110.487|98.367|<0.0001
71059083|NCT02096744|141624904|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means Catapres-TTS-3(Oppanol/Vistanex) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|102.78|STANDARD_ERROR_OF_MEAN|15.8|<|0.0001|TWO_SIDED|90.0|97.25|108.63|||ANOVA|ANOVA on the logarithmic scale including effects for 'Group', 'sequence', 'subjects within sequences', 'period', and 'treatment'.|"The estimated value is actually the ratio of Catapres-TTS-3 with Oppanol and Catapres-TTS-3 with Vistanex.~The value in parameter dispersion type and dispersion value is actually the intra-individual gCV."|||108.63|97.25|<0.0001
71059084|NCT02096744|141624905|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means Catapres-TTS-3(Oppanol/Vistanex) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|104.04|STANDARD_ERROR_OF_MEAN|16.7|<|0.0001|TWO_SIDED|90.0|98.148|110.294|||ANOVA|ANOVA on the logarithmic scale including effects for 'Group','sequence', 'subjects within sequences', 'period', and 'treatment'.|"The estimated value is actually the ratio of Catapres-TTS-3 with Oppanol and Catapres-TTS-3 with Vistanex.~The value in parameter dispersion type and dispersion value is actually the intra-individual gCV."|||110.294|98.148|<0.0001
71059085|NCT00625872|141624927|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.43|STANDARD_ERROR_OF_MEAN|1.1||0.7232|TWO_SIDED|95.0|-3.93|3.08||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||Analysis of covariance (ANCOVA) method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||3.08|-3.93|0.7232
71059086|NCT00625872|141624928|SUPERIORITY_OR_OTHER||LS Mean difference|-1.61|STANDARD_ERROR_OF_MEAN|0.51||0.1941|TWO_SIDED|95.0|-8.04|4.82||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||4.82|-8.04|0.1941
71059087|NCT00625872|141624930|SUPERIORITY_OR_OTHER|||||||0.0532||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For K-ABC Test (Sequential Processing): Kruskal-Wallis Analysis of Variance (ANOVA) model was used to calculate p-value.||||0.0532
71059088|NCT00625872|141624930|SUPERIORITY_OR_OTHER|||||||0.3383||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For K-ABC Test (Simultaneous Processing): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.3383
71059089|NCT00625872|141624930|SUPERIORITY_OR_OTHER|||||||0.683||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For K-ABC Test (Achievement): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.6830
71059090|NCT00625872|141624930|SUPERIORITY_OR_OTHER|||||||0.4935||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For K-ABC Test (Non-Verbal): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.4935
71059091|NCT00625872|141624930|SUPERIORITY_OR_OTHER|||||||0.3458||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For K-ABC Test (Mental Processing Composite): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.3458
71059092|NCT00625872|141624932|SUPERIORITY_OR_OTHER|||||||0.6256||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For KITAP Test (Distractibility): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.6256
71059093|NCT00625872|141624932|SUPERIORITY_OR_OTHER|||||||0.859||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For KITAP Test (Alertness): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.8590
71059094|NCT00625872|141624932|SUPERIORITY_OR_OTHER|||||||1||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For KITAP Test (Flexibility): Kruskal-Wallis ANOVA model was used to calculate p-value.||||1.0000
71059095|NCT00625872|141624932|SUPERIORITY_OR_OTHER|||||||0.1234||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For KITAP Test (Go/No Go): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.1234
71059096|NCT00625872|141624932|SUPERIORITY_OR_OTHER|||||||0.3291||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For KITAP Test (Vigilance): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.3291
70935477|NCT01482091|141372009|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71059097|NCT00625872|141624951|SUPERIORITY_OR_OTHER||LS Mean difference|0.14|STANDARD_ERROR_OF_MEAN|2.54||0.956|TWO_SIDED|95.0|-5.71|6.0||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||6.00|-5.71|0.9560
70935478|NCT01482091|141372013|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||||||>0.05
70935479|NCT01480258|141372014|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-PRP ≥ 1.0 μg/mL||||<0.001
71059098|NCT00625872|141624967|SUPERIORITY_OR_OTHER||LS Mean difference|0.55|STANDARD_ERROR_OF_MEAN|0.31||0.1107|TWO_SIDED|95.0|-0.15|1.25||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||1.25|-0.15|0.1107
71059099|NCT00625872|141624969|SUPERIORITY_OR_OTHER||LS Mean difference|4.67|STANDARD_ERROR_OF_MEAN|1.54||0.0161|TWO_SIDED|95.0|1.13|8.21||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||8.21|1.13|0.0161
71059100|NCT00625872|141624978|SUPERIORITY_OR_OTHER||LS Mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.25||0.187|TWO_SIDED|95.0|-0.89|0.2||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||Triceps SDS: ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||0.20|-0.89|0.1870
71059101|NCT00625872|141624978|SUPERIORITY_OR_OTHER||LS Mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.15||0.3494|TWO_SIDED|95.0|-0.49|0.19||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||Subscapular SDS: ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||0.19|-0.49|0.3494
71059102|NCT00625872|141624978|SUPERIORITY_OR_OTHER||LS Mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.12||0.0458|TWO_SIDED|95.0|-0.54|-0.01||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||Suprailiac SDS: ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||-0.01|-0.54|0.0458
71059103|NCT00852202|141624980|SUPERIORITY|||||||0.7408|||||||ANCOVA|||||||0.7408
71059104|NCT00852202|141624980|SUPERIORITY|||||||0.9961|||||||ANCOVA|||||||0.9961
71059105|NCT00852202|141624981|SUPERIORITY|||||||0.3441|||||||ANCOVA|||||||0.3441
71059106|NCT00852202|141624981|SUPERIORITY|||||||0.2683|||||||ANCOVA|||||||0.2683
71059107|NCT02972892|141624982|NON_INFERIORITY|Using t-test, comparison of the weighted average percent duration between the Et Control and control device was performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for both EtAA.|Mean Difference (Net)|10.9|||<|0.001|TWO_SIDED|95.0|6.89|15.01|||t-test, 2 sided|||Using t-test, comparison of the weighted average percent duration between the Et Control and control device was performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for both EtAA.||15.01|6.89|<.001
71059108|NCT02972892|141624983|NON_INFERIORITY|Using t-test, comparison of the weighted average percent duration between the Et Control and control device was performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for both EtAA.|Mean Difference (Net)|52.1|||<|0.001|TWO_SIDED|95.0|46.25|57.95|||t-test, 2 sided|||Using t-test, comparison of the weighted average percent duration between the Et Control and control device was performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for both EtAA.||57.95|46.25|<.001
71059109|NCT02972892|141624984|NON_INFERIORITY|Using t-test, comparison of the weighted average percent duration between the Et Control and control device will be performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for EtO2.|Mean Difference (Net)|5.3|||<|0.001|TWO_SIDED|95.0|2.64|8.04|||t-test, 2 sided|||Using t-test, comparison of the weighted average percent duration between the Et Control and control device will be performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for EtO2.||8.04|2.64|<.001
71059110|NCT02972892|141624985|NON_INFERIORITY|Using t-test, comparison of the weighted average percent duration between the Et Control and control device will be performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for EtO2.|Mean Difference (Net)|44.5|||<|0.001|TWO_SIDED|95.0|35.56|53.41|||t-test, 2 sided|||Using t-test, comparison of the weighted average percent duration between the Et Control and control device will be performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for EtO2.||53.41|35.56|<.001
71059111|NCT01682811|141625011|OTHER|||||||0.0001|||||||t-test, 1 sided|||One-sample t-test comparing the absolute value to an alternate expected value of zero.||||0.0001
71059112|NCT01682811|141625014|OTHER|||||||0.24|||||||t-test, 2 sided|||Paired comparisons between treated and placebo lesions within subject.||||0.24
71059113|NCT01682811|141625017|OTHER|||||||0.002|||||||t-test, 2 sided|||||||0.002
71059114|NCT02694328|141625018|SUPERIORITY||Least Squares Mean Difference|-2.38|STANDARD_ERROR_OF_MEAN|0.765||0.003|TWO_SIDED|95.0|-3.88|-0.88||P-value was adjusted using the Cui, Hung, and Wang (CHW) method to account for the unblinded interim analysis for sample size re-estimation.|ANCOVA|Missing values at Week 24 were imputed using multiple imputation.||||-0.88|-3.88|0.003
71059115|NCT02694328|141625019|SUPERIORITY||Risk Difference (RD)|-13.7||||0.003|TWO_SIDED|95.0|-22.8|-4.6||P-value was adjusted using the CHW method to account for the unblinded interim analysis for sample size re-estimation.|Regression, Logistic|Missing values at Week 24 were imputed using multiple imputation.|Risk difference (RD) of ALKS 3831 vs. Olanzapine|||-4.6|-22.8|0.003
71059116|NCT02694328|141625020|SUPERIORITY||Risk Difference (RD)|-15.9||||0.001|TWO_SIDED|95.0|-25.3|-6.5|||Regression, Logistic|Missing values at Week 24 were imputed using multiple imputation.|Risk difference (RD) ALKS 3831 vs. Olanzapine|||-6.5|-25.3|0.001
71059117|NCT02514447|141625022|SUPERIORITY||||||<|0.0001||||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (primary and key secondary myelosuppression efficacy endpoints) in a strong sense at a 1-sided 0.10 level.|non-parametric ANCOVA|Hochberg-based gatekeeping procedure||Analysis was for Part 2 data: Treatment difference was evaluated using a nonparametric analysis of covariance (ANCOVA). The nonparametric ANCOVA included study baseline ANC value as covariate, stratification factors of ECOG performance status (0 to 1 versus 2) and sensitivity to first line treatment (sensitive or resistant) and treatment as fixed effects.||||<0.0001
71059118|NCT02514447|141625023|SUPERIORITY|||||||0.016||||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (primary and key secondary myelosuppression efficacy endpoints) in a strong sense at a 1-sided 0.10 level.|Modified Poisson|Hochberg-based gatekeeping procedure||The occurrence of SN was a binary variable. Treatment group difference was analyzed using modified Poisson regression to account for the variable duration of the Treatment Period for each patient. The model included baseline ANC as a covariate, stratification factors of ECOG performance status (0 or 1 vs 2), sensitivity to 1st line treatment (sensitive or resistant), and treatment as fixed effects. The logarithm transformation of # of cycles was included as an offset variable in the modeling.||||0.0160
71059119|NCT03367572|141625045|SUPERIORITY||Mean Difference (Net)|0.7056||||0.008|TWO_SIDED||||||ANOVA|||||||0.008
71059120|NCT03367572|141625045|SUPERIORITY||Mean Difference (Net)|1.1486|||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
71059121|NCT03367572|141625046|SUPERIORITY||Mean Difference (Net)|0.4468||||0.01|TWO_SIDED||||||ANOVA|||||||0.010
71059122|NCT03367572|141625046|SUPERIORITY||Mean Difference (Net)|0.5632||||0.001|TWO_SIDED||||||ANOVA|||||||0.001
71059123|NCT03367572|141625047|SUPERIORITY||Mean Difference (Net)|-0.59||||0.019|TWO_SIDED||||||t-test, 2 sided|||"Secondary Aim 1 is to determine if olanzapine is more effective than prochlorperazine in controlling nausea at Cycle 2 in participants who experienced CINV at Cycle 1 when used in combination with netupitant, palonosetron and dexamethasone.~This will be assessed by estimating the contrast D = (3 - 1) - (2 - 1), where 3 is the Arm 3 mean, 2 is the Arm 2 mean, and 1 is the Control mean, and testing whether D = 0 versus the one-sided alternative hypothesis that D \> 0."||||0.019
71059124|NCT03367572|141625048|SUPERIORITY||Odds Ratio (OR)|1.31||||0.386|TWO_SIDED|97.5|0.65|2.66||prochlorperazine arm statistics|Regression, Logistic|||||2.66|0.65|0.386
71059125|NCT03367572|141625048|SUPERIORITY||Odds Ratio (OR)|0.16||||0.036|TWO_SIDED|97.5|0.02|1.13||olanzapine arm statistics|Regression, Logistic|||||1.13|0.02|0.036
71059126|NCT02731638|141625068|SUPERIORITY||Odds Ratio (OR)|1.82||||0.26|TWO_SIDED|95.0|0.65|5.23|||Regression, Logistic|Bias-corrected logistic regression, accounting for baseline culture status||||5.23|0.65|0.26
71059127|NCT02731638|141625069|SUPERIORITY||Coefficient|1.6||||0.25|TWO_SIDED|95.0|-1.2|4.4|||Regression, Linear||Positive coefficients of the logMAR value indicated worsened visual acuity|||4.4|-1.2|0.25
71059128|NCT02731638|141625069|SUPERIORITY||Coefficient|0.5||||0.75|TWO_SIDED|95.0|-2.6|3.6|||Regression, Linear||Positive coefficients of the logMAR value indicate worsened visual acuity|||3.6|-2.6|0.75
71109247|NCT02163577|141723982|SUPERIORITY|||||||0.0016||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0016
71059129|NCT05878093|141625091|SUPERIORITY|A hierarchical procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Least square mean difference|-1.84|||<|0.0001|TWO_SIDED|95.0|-2.53|-1.15|||ANCOVA||Data was analyzed by fitting an analysis of covariance (ANCOVA) model with the corresponding baseline value, treatment group, and screening blood eosinophil count strata as covariates.|||-1.15|-2.53|<0.0001
71059130|NCT05878093|141625092|SUPERIORITY|A hierarchical procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Least square mean difference|-0.54||||0.0126|TWO_SIDED|95.0|-0.97|-0.12|||ANCOVA||Data was analyzed by fitting an ANCOVA model with the corresponding baseline value, treatment group, and screening blood eosinophil count strata as covariates.|||-0.12|-0.97|0.0126
71109248|NCT02163577|141723982|SUPERIORITY|||||||0.5677||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||0.5677
71109249|NCT02163577|141723982|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71109250|NCT02163577|141723983|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
70935480|NCT01480258|141372014|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-HBsAg ≥10 mIU/mL||||<0.001
71059131|NCT05878093|141625093|SUPERIORITY|A hierarchical procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Least square mean difference|-1.68||||0.0008|TWO_SIDED|95.0|-2.67|-0.69|||ANCOVA||Data was analyzed by fitting an ANCOVA model with the corresponding baseline value, treatment group, and screening blood eosinophil count strata as covariates.|||-0.69|-2.67|0.0008
71059132|NCT05878093|141625094|SUPERIORITY|A hierarchical procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Least square mean difference|-0.62||||0.0072|TWO_SIDED|95.0|-1.08|-0.17|||ANCOVA||Data was analyzed by fitting an ANCOVA model with the corresponding baseline value, treatment group, and screening blood eosinophil count strata as covariates.|||-0.17|-1.08|0.0072
71059133|NCT05878093|141625095|SUPERIORITY|A hierarchical procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Least square mean difference|-9.52||||0.0104|TWO_SIDED|95.0|-16.81|-2.24|||ANCOVA||Data was analyzed by fitting an ANCOVA model with the corresponding baseline value, treatment group, and screening blood eosinophil count strata as covariates.|||-2.24|-16.81|0.0104
71109251|NCT02163577|141723983|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
71109252|NCT02163577|141723983|SUPERIORITY|||||||0.0033||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0033
70935481|NCT01480258|141372014|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-Diphtheria ≥0.1 IU/mL||||<0.001
70935482|NCT01480258|141372014|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-Tetanus ≥0.1 IU/mL||||<0.001
71026202|NCT02295774|141559742|SUPERIORITY_OR_OTHER||Mc Nemar's χ2 test|0.0|||||TWO_SIDED|||||||Mc Nemar's χ2 test was not applicable because there is no change between visits.|Mc Nemar's χ2 test was not applicable because there is no change between visits.|"The results of the γH2AX analysis were listed and summarised by frequency tables by visit and colonic region.~The results were compared between Visit 2 and Visit 1 for each colonic region and overall using the Mc Nemar's χ2 test.~In case of the presence of at least one positive colonic region, that visit was to be considered as 'Positive' for the overall γH2AX analysis."||||
71026203|NCT01075763|141559744|SUPERIORITY_OR_OTHER|||||||0.64|||||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.64
71026204|NCT01075763|141559744|SUPERIORITY_OR_OTHER|||||||0.92|||||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.92
71026205|NCT01075763|141559745|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||t-test, 2 sided|||For Week 12: the difference between the two groups was analyzed using t-test.||||0.63
71026206|NCT01075763|141559745|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.74
71026207|NCT01075763|141559746|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.45
71026208|NCT01075763|141559746|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||t-test, 2 sided|||For Week 12: the difference between the two groups was analyzed using t-test.||||0.88
71026209|NCT01075763|141559746|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.68
71026210|NCT01075763|141559746|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.81
71109253|NCT02163577|141723983|SUPERIORITY|||||||0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0001
71026211|NCT01075763|141559747|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.29
71026212|NCT01075763|141559747|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||t-test, 2 sided|||For Week 12: the difference between the two groups was analyzed using t-test.||||0.36
71026213|NCT01075763|141559747|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.68
71026214|NCT01075763|141559747|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.41
71109254|NCT02163577|141723983|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
70935483|NCT01480258|141372014|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-PT seroresponse||||<0.001
70935484|NCT01480258|141372014|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-FHA seroresponse||||<0.001
71026215|NCT01075763|141559748|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.86
71026216|NCT01075763|141559748|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.62
71026217|NCT01075763|141559748|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.21
71026218|NCT01075763|141559749|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.95
71026219|NCT01075763|141559749|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.73
71026220|NCT01075763|141559749|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.30
71026221|NCT01075763|141559751|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.80
71026222|NCT01075763|141559751|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.74
71026223|NCT01075763|141559751|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.12
71026224|NCT01075763|141559752|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.53
71026225|NCT01075763|141559752|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.85
71026226|NCT01075763|141559752|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.85
71026227|NCT00586521|141559753|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The primary outcome measure was analyzed by paired t-test and Wilcoxon test (number of joint bleeds prophylaxis treatment compared to number of joint bleeds on-demand treatment) at 6 months of treatment.||||<0.001
71109255|NCT02163577|141723983|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
70935485|NCT01480258|141372014|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-FIM seroresponse||||<0.001
70935486|NCT01480258|141372014|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-PRN seroresponse||||<0.001
70935487|NCT01480258|141372014|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-IPV1 ≥1:8 dilution||||<0.001
70935488|NCT01480258|141372014|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-IPV2 ≥1:8 dilution||||<0.001
70935489|NCT01480258|141372014|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-IPV3 ≥1:8 dilution||||<0.001
70935490|NCT01480258|141372015|NON_INFERIORITY|If the lower bound of the 95% confidence interval (CI) was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|46.2|||<|0.001|TWO_SIDED|95.0|41.05|51.06||Stratification by country.|Miettinen & Nurminen|||||51.06|41.05|<0.001
70935491|NCT01480258|141372016|SUPERIORITY|If the lower bound of the 95% CI was greater than 0, it was concluded that PR5I group response rate was superior to INFANRIX hexa group response rate.|Difference in percentages|46.2|||<|0.001|TWO_SIDED|95.0|41.05|51.06|||Miettinen & Nurminen|Stratification by country.||||51.06|41.05|<0.001
70935492|NCT01480258|141372017|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in PRP response rate (based on Ab titre ≥1.0 μg/mL) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-1.27|||<|0.001|TWO_SIDED|95.0|-5.13|2.52|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-inferiority for PRP||2.52|-5.13|<0.001
70935493|NCT01480258|141372017|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in HBsAg response rate (based on Ab titre ≥10 mIU/mL) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|ifference in percentages|-0.59|||<|0.001|TWO_SIDED|95.0|-2.66|1.35|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for HBsAg||1.35|-2.66|<0.001
70935494|NCT01480258|141372017|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in Diphtheria response rate (based on Ab titre ≥0.1 IU/mL) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-1.21|||<|0.001|TWO_SIDED|95.0|-2.54|-0.22|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for Diptheria||-0.22|-2.54|<0.001
70935495|NCT01480258|141372017|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in Tetanus response rate (based on Ab titre ≥0.1 IU/mL) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.17|||<|0.001|TWO_SIDED|95.0|-0.95|0.5|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for Tetanus||0.50|-0.95|<0.001
70935496|NCT01480258|141372017|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in the percentage of seroresponder participants for PT was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.54|||<|0.001|TWO_SIDED|95.0|-1.75|0.49|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for PT||0.49|-1.75|<0.001
70935497|NCT01480258|141372017|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in the percentage of seroresponder participants for FHA was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-1.73|||<|0.001|TWO_SIDED|95.0|-3.47|-0.26|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for FHA||-0.26|-3.47|<0.001
70935498|NCT01480258|141372017|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in the percentage of seroresponder participants for PRN was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-1.42|||<|0.001|TWO_SIDED|95.0|-3.42|0.39|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for PRN||0.39|-3.42|<0.001
70935499|NCT01480258|141372017|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in IPV1 response rate (based on Ab titre ≥8 (1/dil)) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.51|||<|0.001|TWO_SIDED|95.0|-1.59|0.34|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for IPV1||0.34|-1.59|<0.001
70935500|NCT01480258|141372017|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in IPV2 response rate (based on Ab titre ≥8 (1/dil)) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.17|||<|0.001|TWO_SIDED|95.0|-0.96|0.49|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for IPV2||0.49|-0.96|<0.001
70935501|NCT01480258|141372017|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in IPV3 response rate (based on Ab titre ≥8 (1/dil)) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.16|||<|0.001|TWO_SIDED|95.0|-1.2|0.82|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for IPV3||0.82|-1.20|<0.001
70935502|NCT01480258|141372018|NON_INFERIORITY|The estimate for anti-rotavirus IgA GMT ratio (PR5I group/INFANRIX hexa group) was calculated with its 1-sided P-value and 2-sided 95% CI. If the lower bound of the 95% CI for GMT ratio was greater than 0.50 (non-inferiority margin), it was concluded that the Rotarix antigen response in the PR5I group was not inferior to the Rotarix antigen response in the INFANRIX hexa group.|Geometric Mean Titre (GMT) ratio|0.8||||0.011|TWO_SIDED|95.0|0.54|1.2|||ANCOVA|||||1.20|0.54|0.011
70935503|NCT01480258|141372019|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-0.7|1.4||||||ISR or systemic AE||1.4|-0.7|
70935504|NCT01480258|141372019|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.8||||||95.0|-0.3|2.0||||||ISR or V-related systemic AE||2.0|-0.3|
70935505|NCT01480258|141372019|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|2.6|||||TWO_SIDED|95.0|-0.7|6.0||||||At least 1 ISR||6.0|-0.7|
70935506|NCT01480258|141372019|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|2.5|||||TWO_SIDED|95.0|-0.9|5.9||||||At least 1 solicited ISR||5.9|-0.9|
71026228|NCT00586521|141559753|SUPERIORITY_OR_OTHER||||||<|0.001|||||||paired t-test|||The maximum individual reduction in the actual number of joint bleeds after the switch to prophylactic treatment was analyzed by a paired t-test of the individual difference between prophylaxis treatment bleed compared to on-demand treatment bleeds.||||<0.001
71026229|NCT00586521|141559754|SUPERIORITY_OR_OTHER||||||<|0.001|||||||paired t-test|||paired t-test (prophylaxis compared to on-demand) at 6 months of treatment.||||<0.001
71109256|NCT02163577|141723984|SUPERIORITY|||||||0.0014||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.0014
70935507|NCT01480258|141372019|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-1.1|1.4||||||At least 1 systemic AE||1.4|-1.1|
70935508|NCT01480258|141372019|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.8|||||TWO_SIDED|95.0|-0.5|2.2||||||At least 1 vaccine-related systemic AE||2.2|-0.5|
70935509|NCT01480258|141372019|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.8|||||TWO_SIDED|95.0|-0.5|2.2||||||At least 1 solicited systemic AE||2.2|-0.5|
70935510|NCT01480258|141372019|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.9||||||95.0|-0.4|2.3||||||At least 1 vaccine-related solicited systemic AE||2.3|-0.4|
70935511|NCT01480258|141372020|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate whether an overall trend of risk differences existed. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|8.2|||||TWO_SIDED|95.0|3.0|13.3||||||Injection-site erythema||13.3|3.0|
71026230|NCT00586521|141559755|SUPERIORITY_OR_OTHER||||||<|0.001|||||||paired t-test|||The Gilbert Score was the sum of 3 scores: pain (0=no pain to 3=severe pain); bleeding score (0=none to 3=3 or more major bleeds or 7 or more minor bleeds); and physical score (based on swelling, muscle atrophy; and axial deformity (at knee or ankle), range of motion, crepitus on motion, flexion contracture, instability.||||<0.001
70935512|NCT01480258|141372020|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate whether an overall trend of risk differences existed. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|3.4|||||TWO_SIDED|95.0|-1.5|8.3||||||Injection-site pain||8.3|-1.5|
70935513|NCT01480258|141372020|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate whether an overall trend of risk differences existed. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|7.5||||||95.0|2.1|12.9||||||Injection-site swelling||12.9|2.1|
70935514|NCT01480258|141372021|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|-1.1|||||TWO_SIDED|95.0|-2.5|0.3||||||Injection-site bruising||0.3|-2.5|
70935515|NCT01480258|141372021|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-1.5|1.6||||||Injection-site haemorrhage||1.6|-1.5|
71059134|NCT04995029|141625098|SUPERIORITY|Any missed or skipped visit was counted as non-negative or de-facto positive. Difference between DB treatment arms was compared using CMH test accounting for randomization stratification (Opioid injection: Yes/No, Week 6 UDS Fentanyl result: Positive/Negative). Statistical superiority was declared if CMH weighted difference in proportion of responders in the 300-mg arm minus the proportion of responders in the 100-mg arm was \>0 and the 2-sided P-value of CMH test ≤0.05.|CMH treatment difference|2.62||||0.4819|TWO_SIDED|95.0|-4.69|9.93||CMH weighted treatment difference and P-value based on CMH randomization stratified analysis using Sato (1989) variance equation. Treatment difference estimate calculated as weighted average of strata-specific estimates within each analysis stratum.|Cochran-Mantel-Haenszel|Difference between DB treatment arms was compared using CMH test accounting for randomization stratification.||"Based on Phase 3 results, for the primary efficacy endpoint of INDV-6000-401, a sample size of 195 per arm was estimated to provide approximately 90% power at 2-sided 0.05 alpha level to detect a difference of 15.6%.~Since the participant population in this study had more severe OUD compared with the Phase 3 DB study, the responder rates and treatment differences were anticipated to be lower."||9.93|-4.69|0.4819
70935516|NCT01480258|141372021|OTHER||Risk Difference (RD)|2.6|||||TWO_SIDED|95.0|-1.2|6.4||||||Injection-site induration||6.4|-1.2|
71077957|NCT01153009|141664424|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|1.21|<|0.001|TWO_SIDED|95.0|-6.46|-1.69|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||-1.69|-6.46|<0.001
70935517|NCT01480258|141372021|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-0.8|1.5||||||Injection-site nodule||1.5|-0.8|
70935518|NCT01480258|141372021|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|1.1||||||95.0|-0.4|2.7||||||Injection-site warmth||2.7|-0.4|
71077958|NCT01153009|141664425|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.249||||0.348|TWO_SIDED|95.0|0.786|1.984|||Regression, Logistic|P-value is from logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.984|0.786|0.348
71109257|NCT02163577|141723984|SUPERIORITY|||||||0.0028||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.0028
71109258|NCT02163577|141723984|SUPERIORITY|||||||0.0536||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0536
71109259|NCT02163577|141723984|SUPERIORITY|||||||0.0002||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0002
70935519|NCT01480258|141372022|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate whether an overall trend of risk differences existed. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|2.2|||||TWO_SIDED|95.0|-1.3|5.7||||||Crying||5.7|-1.3|
71109260|NCT02163577|141723984|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71109261|NCT02163577|141723984|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
70935520|NCT01480258|141372022|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|3.6|||||TWO_SIDED|95.0|-1.6|8.8||||||Decreased appetite||8.8|-1.6|
71026231|NCT00586521|141559756|SUPERIORITY_OR_OTHER|||||||0.314||||||The alpha level for a significant P-value was pre-defined at 5%.|paired t-test|||"The Haemo-QoL A questionnaire measures the subject's self-assessment of disease impact on physical functioning, role functioning, worry, consequences, positive affect, and treatment concern."||||0.314
71026232|NCT00810732|141559759|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.19||0.004|TWO_SIDED|95.0|-0.94|-0.19|||ANCOVA|||||-0.19|-0.94|0.0040
71026233|NCT00810732|141559759|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.19||0.0018|TWO_SIDED|95.0|-0.99|-0.24|||ANCOVA|||||-0.24|-0.99|0.0018
71026234|NCT00810732|141559759|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.19||0.7945|TWO_SIDED|95.0|-0.33|0.43|||ANCOVA|||||0.43|-0.33|0.7945
71026235|NCT00810732|141559760|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.5|STANDARD_ERROR_OF_MEAN|1.3||0.0087|TWO_SIDED|95.0|-6.08|-0.91|||ANCOVA|||Mean Systemic Arterial BP: Week 3||-0.91|-6.08|0.0087
71026236|NCT00810732|141559760|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.92|STANDARD_ERROR_OF_MEAN|1.3||0.1424|TWO_SIDED|95.0|-4.5|0.66|||ANCOVA|||Mean Systemic Arterial BP: Week 3||0.66|-4.50|0.1424
71026237|NCT00810732|141559760|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.58|STANDARD_ERROR_OF_MEAN|1.29||0.2277|TWO_SIDED|95.0|-4.15|1.0|||ANCOVA|||Mean Systemic Arterial BP: Week 3||1.00|-4.15|0.2277
71026238|NCT00810732|141559760|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.56|STANDARD_ERROR_OF_MEAN|1.81||0.1599|TWO_SIDED|95.0|-6.16|1.03|||ANCOVA|||Systolic Blood Pressure: Week 3||1.03|-6.16|0.1599
71026239|NCT00810732|141559760|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.07|STANDARD_ERROR_OF_MEAN|1.8||0.5545|TWO_SIDED|95.0|-4.66|2.52|||ANCOVA|||Systolic Blood Pressure: Week 3||2.52|-4.66|0.5545
71026240|NCT00810732|141559760|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.49|STANDARD_ERROR_OF_MEAN|1.8||0.4095|TWO_SIDED|95.0|-5.08|2.09|||ANCOVA|||Systolic Blood Pressure: Week 3||2.09|-5.08|0.4095
71026241|NCT00810732|141559760|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.08|STANDARD_ERROR_OF_MEAN|1.21||0.0012|TWO_SIDED|95.0|-6.49|-1.67|||ANCOVA|||Diastolic Blood Pressure: Week 3||-1.67|-6.49|0.0012
71026242|NCT00810732|141559760|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.98|STANDARD_ERROR_OF_MEAN|1.21||0.0159|TWO_SIDED|95.0|-5.38|-0.57|||ANCOVA|||Diastolic Blood Pressure: Week 3||-0.57|-5.38|0.0159
71026243|NCT00810732|141559760|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.21||0.3627|TWO_SIDED|95.0|-3.51|1.3|||ANCOVA|||Diastolic Blood Pressure: Week 3||1.30|-3.51|0.3627
71077959|NCT01153009|141664425|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.257||||0.332|TWO_SIDED|95.0|0.792|1.994||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops for this dose and for subsequent endpoints in the sequence a nominal p-value is provided.|Regression, Logistic|P-value is from logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.994|0.792|0.332
71077960|NCT01153009|141664425|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.991||||0.004|TWO_SIDED|95.0|1.25|3.171|||Regression, Logistic|P-value is from logistic regression with explanatory variables for treatment and Baseline MADRS score.||||3.171|1.250|0.004
71077961|NCT01153009|141664426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.14||0.4|TWO_SIDED|95.0|-0.39|0.16|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||0.16|-0.39|0.400
71026244|NCT00810732|141559760|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.36|STANDARD_ERROR_OF_MEAN|1.16||0.0057|TWO_SIDED|95.0|-5.69|-1.03|||ANCOVA|||Mean Systemic Arterial BP: Week 6||-1.03|-5.69|0.0057
71026245|NCT00810732|141559760|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|1.16||0.6503|TWO_SIDED|95.0|-2.86|1.8|||ANCOVA|||Mean Systemic Arterial BP: Week 6||1.80|-2.86|0.6503
71026246|NCT00810732|141559760|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.83|STANDARD_ERROR_OF_MEAN|1.16||0.0183|TWO_SIDED|95.0|-5.16|-0.5|||ANCOVA|||Mean Systemic Arterial BP: Week 6||-0.50|-5.16|0.0183
71026247|NCT00810732|141559760|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.81|STANDARD_ERROR_OF_MEAN|1.53||0.0726|TWO_SIDED|95.0|-5.89|0.27|||ANCOVA|||Systolic Blood Pressure (SBP): Week 6||0.27|-5.89|0.0726
71026248|NCT00810732|141559760|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.07|STANDARD_ERROR_OF_MEAN|1.53||0.9661|TWO_SIDED|95.0|-3.01|3.14|||ANCOVA|||Systolic Blood Pressure (SBP): Week 6||3.14|-3.01|0.9661
71026249|NCT00810732|141559760|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.88|STANDARD_ERROR_OF_MEAN|1.53||0.0656|TWO_SIDED|95.0|-5.94|0.19|||ANCOVA|||Systolic Blood Pressure (SBP): Week 6||0.19|-5.94|0.0656
71026250|NCT00810732|141559760|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.16|STANDARD_ERROR_OF_MEAN|1.11||0.0068|TWO_SIDED|95.0|-5.39|-0.92|||ANCOVA|||Diastolic Blood Pressure (DBP): Week 6||-0.92|-5.39|0.0068
71026251|NCT00810732|141559760|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.99|STANDARD_ERROR_OF_MEAN|1.11||0.376|TWO_SIDED|95.0|-3.22|1.24|||ANCOVA|||Diastolic Blood Pressure (DBP): Week 6||1.24|-3.22|0.3760
71026252|NCT00810732|141559760|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.16|STANDARD_ERROR_OF_MEAN|1.11||0.0572|TWO_SIDED|95.0|-4.4|0.07|||ANCOVA|||Diastolic Blood Pressure (DBP): Week 6||0.07|-4.40|0.0572
71026253|NCT00810732|141559761|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.21||0.8823|TWO_SIDED|95.0|-0.39|0.45|||ANCOVA|||Week 3||0.45|-0.39|0.8823
71026254|NCT00810732|141559761|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.21||0.9457|TWO_SIDED|95.0|-0.41|0.43|||ANCOVA|||Week 3||0.43|-0.41|0.9457
71026255|NCT00810732|141559761|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.21||0.9358|TWO_SIDED|95.0|-0.4|0.44|||ANCOVA|||Week 3||0.44|-0.40|0.9358
71026256|NCT00810732|141559761|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.19||0.0022|TWO_SIDED|95.0|-1.03|-0.25|||ANCOVA|||Week 6||-0.25|-1.03|0.0022
71026257|NCT00810732|141559761|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.19||0.8956|TWO_SIDED|95.0|-0.41|0.36|||ANCOVA|||Week 6||0.36|-0.41|0.8956
71026258|NCT00810732|141559761|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.19||0.003|TWO_SIDED|95.0|-1.0|-0.23|||ANCOVA|||Week 6||-0.23|-1.00|0.0030
71109262|NCT02163577|141723985|SUPERIORITY|||||||0.223||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.2230
71026259|NCT02261428|141559762|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.95|||<|0.05|TWO_SIDED|95.0|1.79|8.73|||Wilcoxon (Mann-Whitney)|||||8.73|1.79|<0.05
71026260|NCT02006706|141559786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.98|STANDARD_ERROR_OF_MEAN|0.606|<|0.001|TWO_SIDED|95.0|1.73|4.22|||t-test, 2 sided||The null hypothesis was that there was no difference between the DAS28 at baseline and DAS28 after 24 weeks of follow-up|||4.22|1.73|<0.001
71026261|NCT02006706|141559787|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71026262|NCT01176448|141559806|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|With 12 scars (or pairs to compare), our power calculation had a 95 percent probability that the study will detect a treatment difference at a two-sided 0.05 percent significance level, if a significant difference between treatments is 1.5 units (based on a 0-4 scale as mentioned above). This is based on the assumption that the within-patient standard deviation of the response variable is 0.5 units.||||||0.77||95.0||||Appropriately powered, this study failed to reject the null hypothesis that fraxel achieves a similar cosmetic result at 3 months when compared to dermabrasion.|Wilcoxon (Mann-Whitney)|||efficacy outcomes analyzed by 3 surgeons blinded to the treatment and scars evaluated by halves comparing pre-treatment photos to 3-month photos and given a score on the quartile scale described in table 1. The ordinal rater scores of each evaluator were then averaged, and Wilcoxon Signed Ranks performed on the group's scores. (table 5) There were 4 Fraxel winners, 4 Dermabrasion winners, and 4 ties. There was a p value of 0.77 indicating no significant difference between the categories||||.77
71026263|NCT02456532|141559807|OTHER|analyses of variance comparing the three treatment gropus|||||=|0.05|||||||ANOVA|||||||=0.05
71026264|NCT02456532|141559808|OTHER|ANOVA|||||=|0.643|||||||ANOVA|||||||=0.643
71026265|NCT02173704|141559815|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sufficiency: The criterion for a sufficient immune response was that the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:5 should be ≥ 70%.|Single binomial proportion|100.0|||||TWO_SIDED|95.0|97.2|100.0|||Exact test of binomial proportion|||Statistical analysis 5/99 strain: The power to reject the null hypothesis associated with the primary objective for strain 5/99 was 99%.||100|97.2|
71026266|NCT02173704|141559815|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sufficiency: The criterion for a sufficient immune response was that the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥ 1:5 should be ≥ 70%.|single binomial proportion|79.0|||||TWO_SIDED|95.0|71.4|85.8|||Exact test of binomial proportion|||Statistical analysis NZ98/254 strain: The power to reject the null hypothesis associated with the primary objective for strain NZ98/25 was 94%.||85.8|71.4|
71026267|NCT02173704|141559817|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sufficiency: The criterion for a sufficient immune response was that the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:5 should be ≥ 70%.|Single binomial proportion|99.0|||||TWO_SIDED|95.0|95.7|99.98|||Exact test of binomial proportion|||Statistical analysis H44/76 strain: The null hypothesis associated with the primary objective is that the proportion of subjects with hSBA titers ≥ 1:5 one month after the third dose of the Bexsero® vaccine was ≤ 0.70. Assuming the results for the three strains are independent, the power to reject the null hypothesis associated with the primary objectives to demonstrate sufficiency of response (for all three strains was 92%.||99.98|95.7|
71026268|NCT02173704|141559817|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sufficiency: The criterion for a sufficient immune response was that the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:5 should be ≥ 75%.|Single binomial proportion|99.0|||||TWO_SIDED|95.0|94.7|99.82|||Exact test for binomial proportion|||Statistical analysis 5/99 strain: The power to reject the null hypothesis associated with the secondary objective for strain 5/99 was 99%.||99.82|94.7|
71026269|NCT02173704|141559817|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sufficiency: The criterion for a sufficient immune response was that the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:5 should be ≥ 75%.|Single binomial proportion|94.0|||||TWO_SIDED|95.0|88.7|97.4|||Exact test for binomial proportions|||Statistical analysis NZ98/254 strain: The power to reject the null hypothesis associated with the secondary objective for strain NZ98/254 was 99%.||97.4|88.7|
71026270|NCT01617577|141559839|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||ADAScog scores at baseline vs final visit (wk 14); null hypothesis is there is no difference between scores||||0.36
71026271|NCT01617577|141559839|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||PAL(mem) at baseline and 14 wk (final visit): null hypothesis is thereis no difference in score||||0.058
71026272|NCT01617577|141559839|SUPERIORITY_OR_OTHER|||||||0.034||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||PALtot trials adj at baseline vs 14wk (final visit)||||0.034
70935521|NCT01480258|141372022|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|2.2|||||TWO_SIDED|95.0|-1.0|5.4||||||Irritability||5.4|-1.0|
71026273|NCT00729859|141559845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|0.0075||0.28|TWO_SIDED|95.0|0.005|0.035|||paired t-test|||p value for the difference = 0.28||0.035|0.005|0.28
71026274|NCT03267264|141559881|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|17.5|||||TWO_SIDED|95.0|10.3|24.7||||||||24.7|10.3|
71026275|NCT03267264|141559882|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|30.5|||||TWO_SIDED|95.0|16.8|44.3||||||||44.3|16.8|
71077962|NCT01153009|141664426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.139||0.177|TWO_SIDED|95.0|-0.46|0.08|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||0.08|-0.46|0.177
70935522|NCT01480258|141372022|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|6.4|||||TWO_SIDED|95.0|1.5|11.3||||||Pyrexia||11.3|1.5|
71059135|NCT04995029|141625098|SUPERIORITY|Any missed or skipped visit was counted as non-negative or de-facto positive. Difference between DB treatment arms was compared using CMH test accounting for randomization stratification (Opioid injection: Yes/No, Week 6 UDS Fentanyl result: Positive/Negative). Statistical superiority was declared if CMH weighted difference in proportion of responders in the 300-mg arm minus the proportion of responders in the 100-mg arm was \>0 and the 2-sided P-value of CMH test ≤0.05.|CMH treatment difference|12.24|||||TWO_SIDED|95.0|2.35|22.12|||||CMH weighted treatment difference based on CMH randomization stratified analysis using Sato (1989) variance equation. Treatment difference estimate calculated as weighted average of strata-specific estimates within each analysis stratum.|Post-hoc subgroup analyses of the primary endpoint to characterize the population of patients who would benefit from the higher maintenance dosing regimen identified participants who reported using fentanyl ≥14 times per week at Screening as one such group.|The posterior possibility of responder rate difference (300 mg-100 mg) \>0 was estimated (via Bayesian beta-binomial model using non-informative uniform prior, ie, Beta (1,1), within individual treatment groups) to evaluate the superiority of 300 mg over 100 mg. Bayesian posterior probability of superiority 300-mg dose to 100-mg dose=99.099%.|22.12|2.35|
70935523|NCT01480258|141372022|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|5.8|||||TWO_SIDED|95.0|1.7|9.8||||||Somnolence||9.8|1.7|
70935524|NCT01480258|141372022|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|1.8|||||TWO_SIDED|95.0|-3.2|6.9||||||Vomiting||6.9|-3.2|
71059136|NCT04995029|141625098|SUPERIORITY|Any missed or skipped visit was counted as non-negative or de-facto positive. Difference between DB treatment arms was compared using CMH test accounting for randomization stratification (Opioid injection: Yes/No, Week 6 UDS Fentanyl result: Positive/Negative). Statistical superiority was declared if CMH weighted difference in proportion of responders in the 300-mg arm minus the proportion of responders in the 100-mg arm was \>0 and the 2-sided P-value of CMH test ≤0.05.|CMH treatment difference|11.06|||||TWO_SIDED|95.0|0.36|21.56|||||CMH weighted treatment difference and P-value based on CMH randomization stratified analysis using Sato (1989) variance equation. Treatment difference estimate calculated as weighted average of strata-specific estimates within each analysis stratum.|Post-hoc subgroup analyses of the primary endpoint to characterize the population of patients who would benefit from the higher maintenance dosing regimen identified participants who reported using fentanyl daily at Screening as one such group.|The posterior possibility of responder rate difference (300 mg-100 mg) \>0 was estimated (via Bayesian beta-binomial model using non-informative uniform prior, ie, Beta (1,1), within individual treatment groups) to evaluate the superiority of 300 mg over 100 mg. Bayesian posterior probability of superiority of 300-mg dose to 100-mg dose=97.846%|21.56|0.36|
71059137|NCT04995029|141625098|SUPERIORITY|Any missed or skipped visit was counted as non-negative or de-facto positive. Difference between DB treatment arms was compared using CMH test accounting for randomization stratification (Opioid injection: Yes/No, Week 6 UDS Fentanyl result: Positive/Negative). Statistical superiority was declared if CMH weighted difference in proportion of responders in the 300-mg arm minus the proportion of responders in the 100-mg arm was \>0 and the 2-sided P-value of CMH test ≤0.05.|CMH treatment difference|15.37|||||TWO_SIDED|95.0|4.61|26.09|||||CMH weighted treatment difference based on CMH randomization stratified analysis using Sato (1989) variance equation. Treatment difference estimate calculated as weighted average of strata-specific estimates within each analysis stratum.|Post-hoc subgroup analyses of the primary endpoint to characterize the population of patients who would benefit from the higher maintenance dosing regimen identified participants who reported using fentanyl ≥14 times per week AND daily at Screening as one such group.|The posterior possibility of responder rate difference (300 mg-100 mg) \>0 was estimated (via Bayesian beta-binomial model using non-informative uniform prior, ie, Beta (1,1), within individual treatment groups) to evaluate the superiority of 300 mg over 100 mg. Bayesian posterior probability of superiority of 300-mg dose to 100-mg dose=99.675%.|26.09|4.61|
71109263|NCT02163577|141723985|SUPERIORITY|||||||0.1132||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.1132
71109264|NCT02163577|141723985|SUPERIORITY|||||||0.2558||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.2558
70935525|NCT00910962|141372058|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.411|TWO_SIDED|95.0|0.46|1.38|||Cox' proportional hazards model|||||1.38|0.46|0.4110
70935526|NCT00910962|141372058|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.9318|TWO_SIDED|95.0|0.6|1.74|||Cox' proportional hazards model|||||1.74|0.60|0.9318
70935527|NCT00910962|141372058|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.6805|TWO_SIDED|95.0|0.56|1.46|||Cox' proportional hazards model|||||1.46|0.56|0.6805
70935528|NCT00910962|141372059|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.299|TWO_SIDED|95.0|0.39|1.34|||Cox' proportional hazards model|||||1.34|0.39|0.2990
70935529|NCT00910962|141372059|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.8235|TWO_SIDED|95.0|0.6|1.9|||Cox' proportional hazards model|||||1.90|0.60|0.8235
70935530|NCT00910962|141372059|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.659|TWO_SIDED|95.0|0.52|1.51|||Cox' proportional hazards model|||||1.51|0.52|0.6590
70935531|NCT00910962|141372065|SUPERIORITY||test to reference ratio|0.8||||0.151|TWO_SIDED|95.0|0.59|1.09|||Repeated measures ANCOVA|||||1.09|0.59|0.151
70935532|NCT00910962|141372065|SUPERIORITY||test to reference ratio|0.95||||0.744|TWO_SIDED|95.0|0.7|1.29|||Repeated measures ANCOVA|||||1.29|0.70|0.744
71026276|NCT03267264|141559882|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall|20.6|||||TWO_SIDED|95.0|4.1|37.1||||||||37.1|4.1|
71026277|NCT03267264|141559882|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|overal mean|6.2|||||TWO_SIDED|95.0|-7.2|19.5||||||||19.5|-7.2|
71026278|NCT03267264|141559882|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|12.8|||||TWO_SIDED|95.0|-1.1|26.7||||||||26.7|-1.1|
71026279|NCT03267264|141559883|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall mean|18.0|||||TWO_SIDED|95.0|11.3|24.7||||||Overall Comfort||24.7|11.3|
71026280|NCT03267264|141559883|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|15.9|||||TWO_SIDED|95.0|9.9|21.8||||||Anxiety Associated with a Needle Stick Injury||21.8|9.9|
71026281|NCT03267264|141559883|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|15.5|||||TWO_SIDED|95.0|8.9|22.1||||||Injection Pain||22.1|8.9|
71026282|NCT03267264|141559883|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|19.7|||||TWO_SIDED|95.0|13.8|25.7||||||Ease of Use||25.7|13.8|
71026283|NCT03267264|141559884|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|27.8|||||TWO_SIDED|95.0|14.9|40.7||||||Overall Comfort||40.7|14.9|
71077963|NCT01153009|141664426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.139||0.014|TWO_SIDED|95.0|-0.61|-0.07|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||-0.07|-0.61|0.014
71109265|NCT02163577|141723985|SUPERIORITY|||||||0.0814||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0814
70852197|NCT03615040|141192858|SUPERIORITY||Mean Difference (Net)|0.53||||0.469|TWO_SIDED|95.0|-0.91|2.0|||Mixed Models Analysis|||Calculated using mixed effect linear model with dependent variable of the outcome at baseline and follow-up time points (Week 4, 12, 24, 36, 48); explanatory variables of treatment arm, number of exacerbations in the 12 months prior to the trial (stratification factor), visit time point (as categorical variable), baseline score; an interaction term between treatment and visit as fixed effects; and patient identification as a random effect.||2.00|-0.91|0.469
70852198|NCT03615040|141192859|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank sum test of mMRC dyspnoea Week 4||||0.90
70852199|NCT03615040|141192859|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank sum test of mMRC dyspnoea Week 12||||0.95
70852200|NCT03615040|141192859|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank sum test of mMRC dyspnoea Week 24||||0.78
70852201|NCT03615040|141192859|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank sum test of mMRC dyspnoea Week 36||||0.88
70852202|NCT03615040|141192859|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank sum test of mMRC dyspnoea Week 48||||0.78
70852203|NCT03615040|141192860|SUPERIORITY||Mean Difference (Net)|-9.4||||0.236|TWO_SIDED|95.0|-24.9|6.2||Using mixed effect linear model with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and baseline score as fixed effects.|Mixed Models Analysis|||VAS total||6.2|-24.9|0.236
70852204|NCT03615040|141192860|SUPERIORITY||Mean Difference (Net)|-4.9||||0.083|TWO_SIDED|95.0|-10.6|0.7||Using mixed effect linear model with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and baseline score as fixed effects.|Mixed Models Analysis|||VAS Dyspnoea||0.7|-10.6|0.083
71109266|NCT02163577|141723985|SUPERIORITY|||||||0.0093||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||0.0093
71109267|NCT02163577|141723985|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71109268|NCT02163577|141723986|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
71109269|NCT02163577|141723986|SUPERIORITY|||||||0.0006||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.0006
71109270|NCT02163577|141723986|SUPERIORITY|||||||0.026||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0260
71109271|NCT02163577|141723986|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
71109272|NCT02163577|141723986|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71109273|NCT02163577|141723986|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
70935533|NCT00910962|141372065|SUPERIORITY||test to treatment ratio|0.87||||0.317|TWO_SIDED|95.0|0.66|1.14|||Repeated measures ANCOVA|||||1.14|0.66|0.317
70935534|NCT00910962|141372066|SUPERIORITY||test to reference ratio|1.03||||0.83|TWO_SIDED|95.0|0.8|1.32|||ANCOVA|||||1.32|0.80|0.83
70935535|NCT00910962|141372066|SUPERIORITY||test to reference ratio|1.08||||0.56|TWO_SIDED|95.0|0.84|1.39|||ANCOVA|||||1.39|0.84|0.56
71109274|NCT02163577|141723990|SUPERIORITY|||||||0.0003|||||||one sample t test|||Week 40||||0.0003
71109275|NCT02163577|141723990|SUPERIORITY|||||||0.0021|||||||one sample t test|||Week 40||||0.0021
71109276|NCT02163577|141723990|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
71109277|NCT02163577|141723990|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
71109278|NCT02163577|141723990|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 160||||< 0.0001
71109279|NCT02163577|141723990|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 160||||< 0.0001
71109280|NCT01343888|141723999|SUPERIORITY_OR_OTHER||Koch's method|27.5|||<|0.0001|TWO_SIDED|95.0|17.9|37.0||adjusted for genotype and race|Cochran-Mantel-Haenszel||adjusted for genotype and race using Koch's method, with continuity correction|||37.0|17.9|<0.0001
71109281|NCT01343888|141723999|SUPERIORITY_OR_OTHER||Koch's methond|28.6|||<|0.0001|TWO_SIDED|95.0|19.0|38.2||adjusted for genotype and race|Cochran-Mantel-Haenszel||adjusted for genotype and race using Koch's method, with continuity correction|||38.2|19.0|<0.0001
71109282|NCT01343888|141723999|SUPERIORITY_OR_OTHER||Koch's method|-1.0|||||TWO_SIDED|95.0|-7.9|5.8|||||adjusted for genotype and race using Koch's method, with continuity correction|||5.8|-7.9|
71109283|NCT01343888|141724000|SUPERIORITY_OR_OTHER||Koch's method|27.1|||<|0.0001|TWO_SIDED|95.0|17.5|36.7||adjusted for genotype and race|Cochran-Mantel-Haenszel||adjusted for genotype and race using Koch's method, with continuity correction|||36.7|17.5|<0.0001
71109284|NCT01343888|141724000|SUPERIORITY_OR_OTHER||Koch's method|27.8|||<|0.0001|TWO_SIDED|95.0|18.2|37.4||adjusted for genotype and race|Cochran-Mantel-Haenszel||adjusted for genotype and race using Koch's method, with continuity correction|||37.4|18.2|<0.0001
71109285|NCT01343888|141724000|SUPERIORITY_OR_OTHER||Koch's method|-0.6|||||TWO_SIDED|95.0|-7.6|6.3|||||adjusted for genotype and race using Koch's method, with continuity correction|||6.3|-7.6|
71109286|NCT01847092|141724040|SUPERIORITY|||||||0.279|||||||Mixed Models Analysis|||||||0.279
70935536|NCT00910962|141372066|SUPERIORITY||test to reference ratio|1.05||||0.65|TWO_SIDED|95.0|0.84|1.32|||ANCOVA|||||1.32|0.84|0.65
70935537|NCT00910962|141372067|SUPERIORITY||Test to reference ratio|0.77||||0.04|TWO_SIDED|95.0|0.6|0.99|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For 24 hours||0.99|0.60|0.040
70935538|NCT00910962|141372067|SUPERIORITY||test to reference ratio|0.66||||0.001|TWO_SIDED|95.0|0.52|0.85|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For 24 hours||0.85|0.52|0.001
70935539|NCT00910962|141372067|SUPERIORITY||test to reference ratio|0.71||||0.003|TWO_SIDED|95.0|0.57|0.89|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For 24 hours||0.89|0.57|0.003
71109287|NCT01847092|141724041|SUPERIORITY|||||||0.94|||||||ANCOVA|||||||0.94
71109288|NCT01331681|141724044|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.3|||<|0.0001|TWO_SIDED|97.5|6.5|12.0||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value was below the significance level of 0.025, the fixed sequence testing did continue with the first secondary endpoint.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate.|Least square (LS) mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||12.0|6.5|<0.0001
71109289|NCT01331681|141724044|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.1|||<|0.0001|TWO_SIDED|97.5|6.3|11.8||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value was below the significance level of 0.025, the fixed sequence testing did continue with the first secondary endpoint.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate.|LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||11.8|6.3|<0.0001
70935540|NCT00910962|141372067|SUPERIORITY||test to reference ratio|0.56|||<|0.001|TWO_SIDED|95.0|0.4|0.78|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For 48 hours||0.78|0.40|<0.001
71109290|NCT01331681|141724045|SUPERIORITY_OR_OTHER_LEGACY||CMH adjusted difference|28.7|||<|0.0001|TWO_SIDED|97.5|15.8|41.6||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the second secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to gain \>= 10 letters identical in both groups||41.6|15.8|<0.0001
70935541|NCT00910962|141372067|SUPERIORITY||test to reference ratio|0.47|||<|0.001|TWO_SIDED|95.0|0.33|0.65|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For 48 hours||0.65|0.33|<0.001
70935542|NCT00910962|141372067|SUPERIORITY||test to reference ratio|0.51|||<|0.001|TWO_SIDED|95.0|0.38|0.69|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For 48 hours||0.69|0.38|<0.001
71026284|NCT03267264|141559884|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|20.2|||||TWO_SIDED|95.0|8.9|31.6||||||Anxiety Associated with a needle stick injury||31.6|8.9|
71026285|NCT03267264|141559884|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|16.1|||||TWO_SIDED|95.0|3.4|28.8||||||Injection Pain||28.8|3.4|
71059138|NCT04995029|141625099|NON_INFERIORITY|Estimated by Bayesian beta-binomial model using non-informative uniform prior, ie, Beta (1,1), within individual induction arms. Posterior distribution of retention rate difference between arms was used to calculate posterior probability of NI of RI to SoC induction using a 10% NI margin or favorable trend of RI over SoC induction.|Bayesian beta-binomial model|11.82|||||TWO_SIDED|95.0|4.34|19.03|||||Posterior probability of RI NI to SoC, ie, (RI - SoC)\>10%=100.00%|"Null and alternative statistical hypotheses:~H0: retention rate of RI - SoC induction≤-10% (non-inferiority \[NI\] margin of 10%) HA: retention rate of RI-SoC induction\>-10%. Criterion for success (ie, demonstrating non-inferiority \[NI\]) was based on posterior probability of retention rate difference (RI-SoC)\>-10%. NI of RI to SoC induction was declared if the posterior probability was higher than 96%. The 96% critical value was chosen so that the overall 1-sided Type I error was less than 10%."||19.03|4.34|
71059139|NCT04995029|141625099|SUPERIORITY|The posterior possibility of retention rate difference (RI - SoC) greater than 0 was estimated to evaluate the superiority of RI over SoC induction|Bayesian beta-binomial model|11.82|||||TWO_SIDED|95.0|4.34|19.03|||||Posterior probability that RI treatment is superior to SoC treatment=99.90%|If the non-inferiority of rapid induction (RI) to standard of care (SoC) induction was declared, the posterior possibility of retention rate difference (RI - SoC) greater than 0 was estimated to evaluate the superiority of RI over SoC induction.||19.03|4.34|
71059140|NCT04995029|141625100|SUPERIORITY|A Wilcoxon rank sum test (Van Elteren 1960) stratified for randomisation factors was performed to compare the difference between the 2 treatment arms. The test result P-value was used inferentially, if the primary endpoint test was statistically significant.|Mean Difference (Net)|-1.73||||0.8836|TWO_SIDED|95.0|-6.83|3.36|||Wilcoxon rank sum (Van Elteren)|Wilcoxon rank sum test stratified by DB randomisation factor (Van Elteren, 1960).|Van Elteren Test Z-Score for Difference Between Arms (300 mg - 100 mg)=-0.1464|||3.36|-6.83|0.8836
71059141|NCT04995029|141625101|OTHER||CMH Difference|1.26||||0.6111|TWO_SIDED|95.0|-3.61|6.13|||Cochran-Mantel-Haenszel|CMH weighted treatment difference and p-value based on the CMH randomization stratified analysis using the Sato (1989) variance equation.|CMH weighted treatment difference and p-value based on the CMH randomization stratified analysis using the Sato (1989) variance equation.|Opioid abstinence between Weeks 10 to 38 (inclusive) was derived as the participant's number of visits with negative assessments (defined as negative UDS and TLFB for opioid use) divided by 15. Under this derivation, any missed or skipped visits were counted as positive, in accordance with the composite Intercurrent Events Strategy. The opioid use derivation at a specific visit was the same as that used for the primary efficacy endpoint.||6.13|-3.61|0.6111
70935543|NCT00910962|141372067|SUPERIORITY||test to reference ratio|0.68||||0.059|TWO_SIDED|95.0|0.45|1.01|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For 72 hours||1.01|0.45|0.059
70935544|NCT00910962|141372067|SUPERIORITY||test to reference ratio|0.6||||0.013|TWO_SIDED|95.0|0.4|0.9|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For 72 hours||0.90|0.40|0.013
70935545|NCT00910962|141372067|SUPERIORITY||test to reference ratio|0.64||||0.015|TWO_SIDED|95.0|0.45|0.92|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For 72 hours||0.92|0.45|0.015
70935546|NCT00910962|141372067|SUPERIORITY||test to reference ratio|0.7||||0.073|TWO_SIDED|95.0|0.48|1.03|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 2||1.03|0.48|0.073
70935547|NCT00910962|141372067|SUPERIORITY||test to reference ratio|0.7||||0.075|TWO_SIDED|95.0|0.48|1.04|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 2||1.04|0.48|0.075
70935548|NCT00910962|141372067|SUPERIORITY||test to reference ratio|0.7||||0.044|TWO_SIDED|95.0|0.5|0.99|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 2||0.99|0.50|0.044
70935549|NCT00910962|141372067|SUPERIORITY||test to reference ratio|0.78||||0.157|TWO_SIDED|95.0|0.55|1.1|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 4||1.10|0.55|0.157
70935550|NCT00910962|141372067|SUPERIORITY||test to reference ratio|0.9||||0.548|TWO_SIDED|95.0|0.63|1.28|||ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 4||1.28|0.63|0.548
70935551|NCT00910962|141372067|SUPERIORITY||test to reference ratio|0.83||||0.253|TWO_SIDED|95.0|0.61|1.14|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 4||1.14|0.61|0.253
71059142|NCT04995029|141625102|OTHER||Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|-6.0|7.99||||||Opioid abstinence between Weeks 10 to 38 (inclusive) was derived as his/her number of visits with negative assessments (defined as negative UDS and TLFB for opioid use) divided by 15. Under this derivation, any missed or skipped visits were counted as positive, in accordance with the composite intercurrent event strategy.||7.99|-6.00|
71059143|NCT04995029|141625103|OTHER||CMH Difference|2.73|||||TWO_SIDED|95.0|-4.98|10.43||This endpoint was summarized similar to the analysis for #4 above. The opioid abstinence percentage for an individual participant was derived as his/her number of visits with negative assessments divided by 5.|||CMH weighted treatment difference based on the CMH randomization stratified analysis using the Sato (1989) variance equation.|||10.43|-4.98|
71059144|NCT04995029|141625104|OTHER||CMH Difference|0.15|||||TWO_SIDED|95.0|-7.49|7.78|||||CMH weighted treatment difference based on the CMH randomization stratified analysis using the Sato (1989) variance equation.|||7.78|-7.49|
71059145|NCT04995029|141625105|OTHER||Mean Difference (Net)|1.49|||||TWO_SIDED|95.0|-4.8|7.78||||||||7.78|-4.80|
71059146|NCT04995029|141625106|OTHER||Mean Difference (Net)|-0.64|||||TWO_SIDED|95.0|-5.38|4.09||||||||4.09|-5.38|
71026286|NCT03267264|141559884|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|30.7|||||TWO_SIDED|95.0|19.3|42.1||||||Ease of Use||42.1|19.3|
71026287|NCT03267264|141559884|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|20.7|||||TWO_SIDED|95.0|5.3|36.1||||||Overall Comfort||36.1|5.3|
71026288|NCT03267264|141559884|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|19.4|||||TWO_SIDED|95.0|6.0|32.8||||||Anxiety Associated with a needle stick||32.8|6|
71059147|NCT04995029|141625107|OTHER||Mean Difference (Net)|-1.37|||||TWO_SIDED|95.0|-9.0|6.25||||||||6.25|-9.00|
71059148|NCT04995029|141625113|OTHER||CMH Difference|1.54|||||TWO_SIDED|95.0|-7.56|10.65|||||CMH weighted treatment difference based on the CMH randomisation stratified analysis using the Sato (1989) variance equation.|||10.65|-7.56|
71059149|NCT04995029|141625114|OTHER||Cox Proportional Hazard|0.82|||||TWO_SIDED|95.0|0.65|1.03|||||Estimated using a Cox proportional hazard model, with treatment arm as a single covariate, stratified by the randomisation strata. Note that the estimation is impacted by last observed visit for the OLTP (including out-of-window visits).|||1.03|0.65|
71059150|NCT03690388|141625122|SUPERIORITY||Hazard Ratio (HR)|0.22|||<|0.0001|TWO_SIDED|96.0|0.13|0.36|||Log Rank|||||0.36|0.13|< 0.0001
71059151|NCT04100018|141625127|SUPERIORITY||Cox Proportional Hazard|0.96||||0.5901|TWO_SIDED|99.0|0.77|1.19||Boundary for statistical significance p-value \< 0.01|Log Rank|Stratification factor is visceral disease (YES vs NO) as entered in the IRT.||||1.19|0.77|0.5901
71059152|NCT04100018|141625128|SUPERIORITY||Cox Proportional Hazard|1.09||||0.3572|TWO_SIDED|99.41|0.84|1.43||Boundary for statistical significance p-value \< 0.0059. Additional accuracy for p-value: 0.005866.|Log Rank||Stratification factor is visceral disease (YES vs NO) as entered in the IRT.|||1.43|0.84|0.3572
71059153|NCT04100018|141625129|SUPERIORITY||Adjusted Difference|3.8|||||TWO_SIDED|95.0|-4.5|12.1|||||Strata adjusted difference in objective response rate based on DerSimonian and Laird method. Stratified by visceral disease (YES vs NO) as entered in the IRT.|||12.1|-4.5|
71059154|NCT04100018|141625132|SUPERIORITY||Percentage Difference|0.9|||||TWO_SIDED|95.0|-5.2|7.0|||||Strata adjusted difference in objective response rate based on DerSimonian and Laird method. Stratified by visceral disease (YES vs NO) as entered in the IRT.|||7.0|-5.2|
70935552|NCT00910962|141372067|SUPERIORITY||test to reference ratio|0.8||||0.204|TWO_SIDED|95.0|0.58|1.13|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 8||1.13|0.58|0.204
71059155|NCT04100018|141625133|SUPERIORITY||Cox Proportional Hazard|1.0|||||TWO_SIDED|95.0|0.86|1.16|||||Stratification factor is visceral disease (YES vs NO) as entered in the IRT.|||1.16|0.86|
71059156|NCT05736861|141625144|SUPERIORITY|Decision rule based on Bayesian posterior probability of efficacy. The decision threshold was a posterior probability of 0.95. A prespecified skeptical prior for the treatment effect was used to preserve type I error below 0.05.|Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.96|1.17|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.17|0.96|
71059157|NCT05736861|141625145|SUPERIORITY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.4|2.6|||||The interval is a highest-density credible interval. Descriptive analysis is a maximum partial likelihood proportional hazards regression model. Low event rate precluded covariate adjustment.|||2.6|0.4|
71059158|NCT05736861|141625148|SUPERIORITY|Statistical analysis was a Bayesian proportional hazards regression model with covariate adjustment and weakly informative priors.|Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.6|1.8|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.8|0.6|
71077964|NCT01153009|141664427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.93|STANDARD_ERROR_OF_MEAN|2.286||0.684|TWO_SIDED|95.0|-3.58|5.45|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||5.45|-3.58|0.684
71026289|NCT03267264|141559884|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|18.6|||||TWO_SIDED|95.0|3.6|33.7||||||Injection Pain||33.7|3.6|
71026290|NCT03267264|141559884|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|18.4|||||TWO_SIDED|95.0|4.9|31.9||||||Ease of Use||31.9|4.9|
71026291|NCT03267264|141559884|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|8.4|||||TWO_SIDED|95.0|-4.0|20.9||||||Overall Comfort||20.9|-4.0|
71026292|NCT03267264|141559884|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|12.9|||||TWO_SIDED|95.0|1.9|23.8||||||Anxiety Associated with a Needle stick injury||23.8|1.9|
71026293|NCT03267264|141559884|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|7.0|||||TWO_SIDED|95.0|-5.3|19.4||||||Injection Pain||19.4|-5.3|
71026294|NCT03267264|141559884|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|17.7|||||TWO_SIDED|95.0|6.7|28.8||||||Ease of Use||28.8|6.7|
71026295|NCT03267264|141559884|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|15.1|||||TWO_SIDED|95.0|2.1|28.1||||||Overall Comfort||28.1|2.1|
71026296|NCT03267264|141559884|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|11.0|||||TWO_SIDED|95.0|-0.5|22.4||||||Anxiety Associated with a Needle Stick Injury||22.4|-0.5|
71059159|NCT05736861|141625149|SUPERIORITY|Statistical analysis was a Bayesian cumulative probability ordinal regression model with covariate adjustment and weakly informative priors.|Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.5|1.13|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|||1.13|0.50|
71059160|NCT05736861|141625150|SUPERIORITY||Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.39|1.13|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|||1.13|0.39|
71059161|NCT05736861|141625151|SUPERIORITY||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.52|1.91|||||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|1.91|0.52|
71059162|NCT05736861|141625152|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.82|1.25|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.25|0.82|
71059163|NCT05736861|141625152|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.78|1.23|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.23|0.78|
71059164|NCT05736861|141625152|OTHER||Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.82|1.41|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.41|0.82|
71059165|NCT05736861|141625152|OTHER||Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.57|1.01|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.01|0.57|
71109291|NCT01331681|141724045|SUPERIORITY_OR_OTHER_LEGACY||CMH adjusted difference|27.5|||<|0.0001|TWO_SIDED|97.5|14.6|40.5||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the second secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to gain \>= 10 letters identical in both groups||40.5|14.6|<0.0001
70852205|NCT03615040|141192860|SUPERIORITY||Mean Difference (Net)|-2.1||||0.546|TWO_SIDED|95.0|-8.9|4.7||Using mixed effect linear model with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and baseline score as fixed effects.|Mixed Models Analysis|||VAS Cough||4.7|-8.9|0.546
70935553|NCT00910962|141372067|SUPERIORITY||test to reference ratio|0.99||||0.965|TWO_SIDED|95.0|0.71|1.39|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 8||1.39|0.71|0.965
70935554|NCT00910962|141372067|SUPERIORITY||test to reference ratio|0.89||||0.457|TWO_SIDED|95.0|0.66|1.2|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 8||1.20|0.66|0.457
71026297|NCT03267264|141559884|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|20.2|||||TWO_SIDED|95.0|7.4|33.1||||||Injection Pain||33.1|7.4|
71026298|NCT03267264|141559884|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|12.0|||||TWO_SIDED|95.0|0.5|23.5||||||Eae of Use||23.5|0.5|
71026299|NCT03019965|141559917|SUPERIORITY||Risk Ratio (RR)|0.95||||0.156|TWO_SIDED|95.0|0.87|1.02|||Chi-squared||||The efficacy of the maneuver was evaluated by calculating the absolute risk reduction and the number needed to treat.|1.02|0.87|0.156
71026300|NCT03019965|141559918|SUPERIORITY||Risk Ratio (RR)|2.98||||0.722|TWO_SIDED|95.0|0.31|28.45|||Chi-squared|||||28.45|0.31|0.722
71026301|NCT01166568|141560002|SUPERIORITY||binomial distribution|0.75||||0.025|ONE_SIDED|97.5|0.75|||the p-value is adjusted for multiple comparisons|Fisher Exact|||"The PSI procedure is defined as successful if 75% of subjects achieve the first primary endpoint or second primary endpoint. The corresponding statistical hypotheses are as follows:~H0 (null hypothesis): p1 ≤ 0.75 Ha (alternative hypothesis): p1 \> 0.75, Where, p1 is the probability of subjects achieving the first primary endpoint. H0 (null hypothesis): p2 ≤ 0.75 Ha (alternative hypothesis): p2 \> 0.75, Where, p2 is the probability of subjects achieving the second primary endpoint."|||0.75|0.025
71026302|NCT03335371|141560021|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_DEVIATION|0.087|<|0.0001|TWO_SIDED|95.0|-0.39|-0.04|||ANCOVA|||||-0.04|-0.39|<0.0001
71026303|NCT01656889|141560076|SUPERIORITY_OR_OTHER|||||||0.5896|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value is based on the chi-squared proportion of wounds closed in each group.||||||0.5896
71026304|NCT01656889|141560077|SUPERIORITY_OR_OTHER|||||||0.3675|TWO_SIDED|0.0|||||Regression, Cox|||||||.3675
71026305|NCT01656889|141560078|SUPERIORITY_OR_OTHER|||||||0.6426|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 01||||0.6426
71026306|NCT01656889|141560078|SUPERIORITY_OR_OTHER|||||||0.3843|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 02||||.3843
71026307|NCT01656889|141560078|SUPERIORITY_OR_OTHER|||||||0.2792|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 03||||0.2792
71026308|NCT01656889|141560078|SUPERIORITY_OR_OTHER|||||||0.1502|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 04||||0.1502
71026309|NCT01656889|141560078|SUPERIORITY_OR_OTHER|||||||0.3823|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 05||||0.3823
71026310|NCT01656889|141560078|SUPERIORITY_OR_OTHER|||||||0.5528|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 06||||0.5528
71026311|NCT01656889|141560078|SUPERIORITY_OR_OTHER|||||||0.02913|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 07||||.02913
71026312|NCT01656889|141560078|SUPERIORITY_OR_OTHER|||||||0.3896|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 08||||0.3896
71026313|NCT01656889|141560078|SUPERIORITY_OR_OTHER|||||||0.3989|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 09||||0.3989
71026314|NCT01656889|141560078|SUPERIORITY_OR_OTHER|||||||0.8682|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 10||||0.8682
71026315|NCT01656889|141560078|SUPERIORITY_OR_OTHER|||||||0.8083|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 11||||0.8083
71026316|NCT01656889|141560078|SUPERIORITY_OR_OTHER|||||||0.6687|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 12||||0.6687
71026317|NCT01656889|141560080|SUPERIORITY_OR_OTHER|||||||0.3601|TWO_SIDED||||||ANCOVA|||Week 01||||0.3601
71026318|NCT01656889|141560080|SUPERIORITY_OR_OTHER|||||||0.9398|TWO_SIDED||||||ANCOVA|||Week 02||||0.9398
71026319|NCT01656889|141560080|SUPERIORITY_OR_OTHER|||||||0.905|TWO_SIDED||||||ANCOVA|||Week 03||||0.905
71026320|NCT01656889|141560080|SUPERIORITY_OR_OTHER|||||||0.4471|TWO_SIDED||||||ANCOVA|||Week 04||||0.4471
71026321|NCT01656889|141560080|SUPERIORITY_OR_OTHER|||||||0.3004|TWO_SIDED||||||ANCOVA|||Week 05||||0.3004
71026322|NCT01656889|141560080|SUPERIORITY_OR_OTHER|||||||0.1815|TWO_SIDED||||||ANCOVA|||Week 06||||0.1815
71026323|NCT01656889|141560080|SUPERIORITY_OR_OTHER|||||||0.399|TWO_SIDED||||||ANCOVA|||Week 07||||0.399
71026324|NCT01656889|141560080|SUPERIORITY_OR_OTHER|||||||0.8027|TWO_SIDED||||||ANCOVA|||Week 08||||0.8027
71026325|NCT01656889|141560080|SUPERIORITY_OR_OTHER|||||||0.4913|TWO_SIDED||||||ANCOVA|||Week 09||||0.4913
71026326|NCT01656889|141560080|SUPERIORITY_OR_OTHER|||||||0.5227|TWO_SIDED||||||ANCOVA|||Week 10||||0.5227
71026327|NCT01656889|141560080|SUPERIORITY_OR_OTHER|||||||0.7032|TWO_SIDED||||||ANCOVA|||Week 11||||0.7032
71026328|NCT01656889|141560080|SUPERIORITY_OR_OTHER|||||||0.9366|TWO_SIDED||||||ANCOVA|||||||0.9366
71109292|NCT01331681|141724046|SUPERIORITY_OR_OTHER_LEGACY||CMH adjusted difference|23.3|||<|0.0001|TWO_SIDED|97.5|12.6|33.9||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the third secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to gain \>= 15 letters identical in both groups||33.9|12.6|<0.0001
71109293|NCT01331681|141724046|SUPERIORITY_OR_OTHER_LEGACY||CMH adjusted difference|24.2|||<|0.0001|TWO_SIDED|97.5|13.5|34.9||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the third secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to gain \>= 15 letters identical in both groups||34.9|13.5|<0.0001
71109294|NCT01331681|141724047|SUPERIORITY_OR_OTHER_LEGACY||CMH adjusted difference|25.8|||<|0.0001|TWO_SIDED|97.5|12.2|39.4||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the fourth secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to improve by \>= 2 steps identical in both groups||39.4|12.2|<0.0001
71109295|NCT01331681|141724047|SUPERIORITY_OR_OTHER_LEGACY||CMH adjusted difference|19.3||||0.0006|TWO_SIDED|97.5|6.6|32.1||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the fourth secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to improve by \>= 2 steps identical in both groups||32.1|6.6|0.0006
71026329|NCT01656889|141560081|SUPERIORITY_OR_OTHER|||||||0.9853|TWO_SIDED||||||ANCOVA|||Week 01||||0.9853
71109296|NCT01331681|141724048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-157.0|||<|0.0001|TWO_SIDED|97.5|-190.9|-123.1||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the fifth secondary endpoint.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate.|LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||-123.1|-190.9|<0.0001
71109297|NCT01331681|141724048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-142.8|||<|0.0001|TWO_SIDED|97.5|-179.3|-106.3||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the fifth secondary endpoint.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate|LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A negative value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||-106.3|-179.3|<0.0001
71026330|NCT01656889|141560081|SUPERIORITY_OR_OTHER|||||||0.7083|TWO_SIDED||||||ANCOVA|||Week 02||||0.7083
71026331|NCT01656889|141560081|SUPERIORITY_OR_OTHER|||||||0.6744|TWO_SIDED||||||ANCOVA|||Week 03||||0.6744
71059166|NCT05736861|141625153|OTHER||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.92|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.32|0.92|
71059167|NCT05736861|141625153|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.83|1.22|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.22|0.83|
71059168|NCT05736861|141625153|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.83|1.24|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.24|0.83|
71059169|NCT05736861|141625153|OTHER||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.72|1.1||||||Day 90|Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|1.10|0.72|
70852206|NCT03615040|141192860|SUPERIORITY||Mean Difference (Net)|-1.9||||0.527|TWO_SIDED|95.0|-7.8|4.0||Using mixed effect linear model with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and baseline score as fixed effects.|Mixed Models Analysis|||VAS Sputum production||4.0|-7.8|0.527
71026332|NCT01656889|141560081|SUPERIORITY_OR_OTHER|||||||0.2891|TWO_SIDED||||||ANCOVA|||||||0.2891
71026333|NCT01656889|141560081|SUPERIORITY_OR_OTHER|||||||0.9923|TWO_SIDED||||||ANCOVA|||Week 05||||0.9923
71026334|NCT01656889|141560081|SUPERIORITY_OR_OTHER|||||||0.1775|TWO_SIDED||||||ANCOVA|||Week 06||||0.1775
71026335|NCT01656889|141560081|SUPERIORITY_OR_OTHER|||||||0.499|TWO_SIDED||||||ANCOVA|||Week 07||||0.499
71026336|NCT01656889|141560081|SUPERIORITY_OR_OTHER|||||||0.4423|TWO_SIDED||||||ANCOVA|||Week 08||||0.4423
71026337|NCT01656889|141560081|SUPERIORITY_OR_OTHER|||||||0.5138|TWO_SIDED||||||ANCOVA|||Week 09||||0.5138
71026338|NCT01656889|141560081|SUPERIORITY_OR_OTHER|||||||0.3409|TWO_SIDED||||||ANCOVA|||Week 10||||0.3409
71026339|NCT01656889|141560081|SUPERIORITY_OR_OTHER|||||||0.6358|TWO_SIDED||||||ANCOVA|||Week 11||||0.6358
71026340|NCT01656889|141560081|SUPERIORITY_OR_OTHER|||||||0.6753|TWO_SIDED||||||ANCOVA|||Week 12||||0.6753
71059170|NCT05736861|141625154|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.8|1.2|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.20|0.80|
70935555|NCT00910962|141372067|SUPERIORITY||test to reference ratio|1.58||||0.008|TWO_SIDED|95.0|1.13|2.22|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 14||2.22|1.13|0.008
70935556|NCT00910962|141372067|SUPERIORITY||test to reference ratio|1.69||||0.002|TWO_SIDED|95.0|1.21|2.38|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 14||2.38|1.21|0.002
70935557|NCT00910962|141372067|SUPERIORITY||test to reference ratio|1.64||||0.001|TWO_SIDED|95.0|1.21|2.21|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 14||2.21|1.21|0.001
70935558|NCT00910962|141372068|SUPERIORITY||test to reference ratio|0.54|||<|0.001|TWO_SIDED|95.0|0.43|0.69|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For 24 hours||0.69|0.43|<0.001
70935559|NCT00910962|141372068|SUPERIORITY||test to reference ratio|0.64|||<|0.001|TWO_SIDED|95.0|0.5|0.82|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For 24 hours||0.82|0.50|<0.001
70935560|NCT00910962|141372068|SUPERIORITY||test to reference ratio|0.59|||<|0.001|TWO_SIDED|95.0|0.48|0.73|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For 24 hours||0.73|0.48|<0.001
71026341|NCT01656889|141560082|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Kaplan-Meier Survival analysis|||||||< 0.05
71109298|NCT01331681|141724049|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.41||||0.2208|TWO_SIDED|97.5|-2.01|6.82||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value is not below of 0.025, the fixed sequence testing stops here. The sixth secondary endpoint cannot be tested confirmatory.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate.|LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||6.82|-2.01|0.2208
71026342|NCT02114307|141560106|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71026343|NCT02114307|141560107|SUPERIORITY|||||||0.0023|||||||t-test, 2 sided|||Sham Group - 6 week Time Point - Pre-stimulation versus Post-Stimulation||||0.0023
71109299|NCT01331681|141724049|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.21||||0.5537|TWO_SIDED|97.5|-5.79|3.37||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value is not below of 0.025, the fixed sequence testing stops here. The sixth secondary endpoint cannot be tested confirmatory.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate.|LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||3.37|-5.79|0.5537
70935561|NCT00910962|141372068|SUPERIORITY||test to reference ratio|0.76||||0.031|TWO_SIDED|95.0|0.59|0.98|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 2||0.98|0.59|0.031
70935562|NCT00910962|141372068|SUPERIORITY||test to reference ratio|0.88||||0.315|TWO_SIDED|95.0|0.68|1.13|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 2||1.13|0.68|0.315
71026344|NCT02114307|141560107|SUPERIORITY|||||||0.0815|||||||t-test, 2 sided|||Test Group - 6 week Time Point - Pre-stimulation versus Post-Stimulation||||0.0815
71026345|NCT02114307|141560108|SUPERIORITY|||||||0.127|||||||t-test, 1 sided|||||||0.127
71029287|NCT01606306|141566071|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||Rank-ordered logistic regression (ROLR) was used to model the probability of best response for each treatment and bootstrapping was used to calculate confidence intervals.|rank-order logistic regression|ROLR is in the class of Discrete Choice models, which seek to estimate the probability that an individual responds best to a specific treatments.||The primary analysis tested the null hypothesis of all three treatments having equal probability to yield the best response as defined by the criteria defining the primary outcome. A sample size of 300 participants was selected to test the primary null hypothesis of all three treatments having equal probability (one-third) to yield the best response with statistical power of at least 0.90 if any one of the three treatments actually has probability of at least one-half to yield the best response.|The probabilistic construct of the Discrete Choice (DC) model does not reflect individual behavior that is intrinsically probabilistic, but rather population heterogeneity. DC models rely on stochastic assumptions to account for unobserved factors related to the treatments themselves and to characteristics of study participants. Specifically, that each treatment has an underlying utility that may differ from one individual to another. Mathematically, these utilities are represented by U\_t, where t denotes the treatment. Utility can be thought of as a latent variable quantifying treatment response where higher values indicate better response. The U\_t can be used to find the probability (P) of best response for each treatment by the following equation: P\_t = exp(U\_t) / \[exp(U\_A) + exp(U\_B) + exp(U\_C)\], where A, B, and C, denote the three study treatments. The primary analysis tested whether the three treatments have equal utility and, thus, equal probability of best response.|||<0.0001
70935563|NCT00910962|141372068|SUPERIORITY||test to reference ratio|0.82||||0.075|TWO_SIDED|95.0|0.65|1.02|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 2||1.02|0.65|0.075
70935564|NCT00910962|141372068|SUPERIORITY||test to reference ratio|0.81||||0.068|TWO_SIDED|95.0|0.65|1.02|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 12||1.02|0.65|0.068
70935565|NCT00910962|141372068|SUPERIORITY||test to reference ratio|0.97||||0.824|TWO_SIDED|95.0|0.78|1.22|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 12||1.22|0.78|0.824
70935566|NCT00910962|141372068|SUPERIORITY||test to reference ratio|0.89||||0.246|TWO_SIDED|95.0|0.73|1.09|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 12||1.09|0.73|0.246
70935567|NCT00910962|141372069|SUPERIORITY||test to reference ratio|1.04||||0.66|TWO_SIDED|95.0|0.89|1.21|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For 72 hours||1.21|0.89|0.66
70935568|NCT00910962|141372069|SUPERIORITY||test to reference ratio|1.07||||0.39|TWO_SIDED|95.0|0.92|1.25|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For 72 hours||1.25|0.92|0.39
70935569|NCT00910962|141372069|SUPERIORITY||test to reference ratio|1.05||||0.47|TWO_SIDED|95.0|0.92|1.21|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For 72 hours||1.21|0.92|0.47
70935570|NCT00910962|141372070|SUPERIORITY||test to reference ratio|0.99||||0.92|TWO_SIDED|95.0|0.78|1.25|||Repeated measures ANCOVA|||||1.25|0.78|0.92
70935571|NCT00910962|141372070|SUPERIORITY||test to reference ratio|1.08||||0.52|TWO_SIDED|95.0|0.85|1.36|||Repeated measures ANCOVA|||||1.36|0.85|0.52
70935572|NCT00910962|141372070|SUPERIORITY||test to reference ratio|1.03||||0.76|TWO_SIDED|95.0|0.84|1.27|||Repeated measures ANCOVA|||||1.27|0.84|0.76
70935573|NCT00910962|141372071|SUPERIORITY||test to reference ratio|0.93||||0.57|TWO_SIDED|95.0|0.72|1.2|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For discharge/early withdrawal||1.20|0.72|0.57
71026346|NCT00458302|141560109|NON_INFERIORITY_OR_EQUIVALENCE|The primary comparison was performed at Week 48. If at Week 48, the lower limit of the 95% two-sided confidence interval of the difference between DRV/r and DRV/r+2NRTIs exceeds -12%, non-inferiority of the DRV/r 800/100 once a day (O.D) monotherapy versus the DRV/r 800/100 mg O.D. plus two NRTIs triple combination therapy was concluded.|Difference in proportion of response|-1.6|||||TWO_SIDED|95.0|-10.1|6.8|||||Difference in proportion of response DRV/r minus DRV/r+2NRTIs.|Assuming a virologic response rate of 90% at 48 weeks for both treatment arms, 111 patients were required per treatment arm to establish non-inferiority of DRV/r versus triple regimen with a maximum allowable difference of 12%, with a one-sided significance level of p=0.025 and 80% power. To account for a maximum of 10% major protocol violations that would be excluded from the on-protocol analysis, 125 patients were recruited in each treatment arm, so 250 patients in total.||6.8|-10.1|
71026347|NCT00458302|141560110|NON_INFERIORITY_OR_EQUIVALENCE|If at Week 48, the lower limit of the 95% two-sided confidence interval of the difference between DRV/r and DRV/r+2NRTIs exceeds -12%, non-inferiority of the DRV/r 800/100 once a day (O.D) monotherapy versus the DRV/r 800/100 mg O.D. plus two NRTIs triple combination therapy was concluded.|Difference in proportion of response|-1.0|||||TWO_SIDED|95.0|-9.9|7.8|||||Difference in proportion of response DRV/r minus DRV/r+2NRTIs.|Assuming a virologic response rate of 90% at 48 weeks for both treatment arms, 111 patients were required per treatment arm to establish non-inferiority of DRV/r versus triple regimen with a maximum allowable difference of 12%, with a one-sided significance level of p=0.025 and 80% power. To account for a maximum of 10% major protocol violations that would be excluded from the on-protocol analysis, 125 patients were recruited in each treatment are, so 250 patients in total.||7.8|-9.9|
71026348|NCT00458302|141560112|SUPERIORITY_OR_OTHER||Difference in proportion of response|1.29|||||TWO_SIDED|95.0|-7.99|10.58|||||Difference in proportion of response DRV/r minus DRV/r+2NRTIs.|||10.58|-7.99|
71026349|NCT01379781|141560137|SUPERIORITY||Slope|-6.54||||0.01|TWO_SIDED||||||Mixed Models Analysis|||Mixed effect model was used to compare Hamilton Rating Scales of Depression (HRSD) for women who received the PREPP intervention between the pre-randomization assessment and the 6 weeks postpartum session.||||.01
71026350|NCT02708290|141560201|OTHER|Participants in the MITA group were matched to those in Control (treatment-as-usual) group using propensity score analysis based on age and all four ATEC subscales at baseline. Least squares means were calculated for all subscales at all visits.|Mean Difference (Final Values)|4.68|||<|0.0001|TWO_SIDED||||||Regression, Linear|||"The concept of a Visit was developed by dividing the three-year-long observation interval into 3-month periods. All evaluations were mapped into 3-month-long bins (Reference: Mahapatra, S. et al. Autism Dev. Disord. 2018, 1). It was then hypothesized that there was a three-way interaction between an age group, Visit, and treatment. This hypothesis was modeled by applying the Linear Model with repeated measures, where a three-way interaction term was introduced to test the hypothesis."||||<0.0001
71026351|NCT01095003|141560205|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0426|TWO_SIDED|95.0|0.71|0.99|||Log Rank|||The final analysis of progression free survival was conducted once the required number of events(615 progressions or deaths) was reached.using the IRC assessment of date of progressions following the blinded radiological and clinical review of data. Kaplan-Meier curves and life tables by treatment arm were provided.A stratified Cox proportional model was used to compare the two treatment arms||0.99|0.71|0.0426
71026352|NCT01095003|141560206|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.7657|TWO_SIDED|95.0|0.83|1.15|||Log Rank|||||1.15|0.83|0.7657
71026353|NCT01095003|141560207|SUPERIORITY|||||||0.103|||||||Cochran-Mantel-Haenszel|||||||0.103
71026354|NCT01095003|141560208|SUPERIORITY|||||||0.0089|||||||Cochran-Mantel-Haenszel|||||||0.0089
71026355|NCT02337933|141560232|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71026356|NCT02337933|141560233|OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
71026357|NCT02337933|141560234|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71026358|NCT02337933|141560235|OTHER|||||||0.308|||||||Wilcoxon (Mann-Whitney)|||||||0.308
71026359|NCT02337933|141560236|OTHER|||||||0.575|||||||Wilcoxon (Mann-Whitney)|||||||0.575
70852207|NCT03615040|141192861|SUPERIORITY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||sputum purulence colour card Week 12||||0.84
71026360|NCT02337933|141560237|OTHER|||||||0.169|||||||Wilcoxon (Mann-Whitney)|||||||0.169
71026361|NCT02337933|141560238|OTHER|||||||0.373|||||||Wilcoxon (Mann-Whitney)|||||||0.373
71026362|NCT02337933|141560239|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71026363|NCT02337933|141560240|OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|||||||0.049
71026364|NCT02337933|141560241|OTHER|||||||0.224|||||||Wilcoxon (Mann-Whitney)|||||||0.224
71026365|NCT02337933|141560242|OTHER|||||||0.116|||||||Wilcoxon (Mann-Whitney)|||||||0.116
71026366|NCT02337933|141560243|OTHER|||||||0.953|||||||Wilcoxon (Mann-Whitney)|||||||0.953
71026367|NCT02337933|141560244|OTHER|||||||0.999|||||||Wilcoxon (Mann-Whitney)|||||||0.999
70852208|NCT03615040|141192861|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||sputum purulence colour card Week 24||||0.52
70935574|NCT00910962|141372071|SUPERIORITY||test to reference ratio|0.92||||0.52|TWO_SIDED|95.0|0.72|1.18|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For discharge/early withdrawal||1.18|0.72|0.52
70935575|NCT00910962|141372071|SUPERIORITY||test to reference ratio|0.92||||0.5|TWO_SIDED|95.0|0.74|1.16|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For discharge/early withdrawal||1.16|0.74|0.50
71029288|NCT03676803|141566072|OTHER||Mean Difference (Final Values)|10.6||||0.033|TWO_SIDED|||||p\<0.05 was defined as significant|ANOVA|||Comparison was made to 2 weeks minus baseline changes in phylum Firmicutes abundance between groups.||||0.033
71109300|NCT01331681|141724050|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.19||||0.5138|TWO_SIDED|97.5|-5.29|2.91|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||2.91|-5.29|0.5138
71109301|NCT01331681|141724050|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37||||0.8498|TWO_SIDED|97.5|-4.79|4.05|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||4.05|-4.79|0.8498
71109302|NCT02394561|141724064|NON_INFERIORITY|The difference in percentage of patients achieving PASI 90 response between the Cw6-positive cohort and the Cw6-negative cohort was H0 = Cw6-positive minus Cw6-negative ≥0.12 and HA = Cw6-positive minus Cw6-negative was \< 0.12. The percentage of PASI 90 response by cohort as well as the difference between cohort together with 97.5% upper CI was provided using Clopper Pearson CI method.|difference|-1.3|||||TWO_SIDED|95.0|-8.8|6.2||||||||6.2|-8.8|
71109303|NCT02394561|141724067|OTHER|difference between cohorts for PASI 90 using Kaplan-Meier estimate||||||0.1295|||||||Log Rank|||||||0.1295
71109304|NCT02394561|141724067|OTHER|||||||0.447||||||difference between cohorts for PASI 75 using Kaplan-Meier estimate|Log Rank|||||||0.4470
71109305|NCT02394561|141724068|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|At all time points||||||<.0001
71109306|NCT02394561|141724069|SUPERIORITY||||||<|0.0001||||||All time points|Wilcoxon (Mann-Whitney)|||||||<.0001
71109307|NCT04577781|141724075|SUPERIORITY||Least Squares (LS) Mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.353||0.885|TWO_SIDED|90.0|-0.66|0.55||Mixed model repeated measure (MMRM) with treatment-by-visit interaction and baseline-by-visit interaction as fixed effects (with an unstructured variance-covariance matrix).|MMRM|||||0.55|-0.66|0.885
71109308|NCT01957865|141724078|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Linear and Poisson regressions|||In an intention-to-treat analysis, percentage doses taken each month were compared by linear generalized estimating equations (GEEs); more than 48-h and more than 96-h lapses in dosingwere compared by Poisson GEE regression.||||<0.05
71109309|NCT01957865|141724079|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher's exact test|||HIV RNA suppression (\<100 copies/ml) was compared among study arms by Fisher's exact test.||||<0.05
71109310|NCT01044030|141724083|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Chi-squared|||||||0.6
71109311|NCT00114127|141724148|SUPERIORITY_OR_OTHER||||||<|0.132||95.0|||||t-test, 2 sided|||||||<0.132
71109312|NCT00114127|141724149|SUPERIORITY_OR_OTHER||||||<|0.292||95.0|||||t-test, 2 sided|||||||<.292
71109313|NCT00881894|141724154|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|0.9864||||||90.0|0.9103|1.0688|||ANOVA|ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||1.0688|0.9103|
71109314|NCT00881894|141724155|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|0.9584||||||90.0|0.8861|1.0367|||ANOVA|ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||1.0367|0.8861|
71109315|NCT00881894|141724156|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|0.9896||||||90.0|0.9179|1.0671|||ANOVA|ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).||Bioequivalence testing by using the 90% Confidence Interval (CI).||1.0671|0.9179|
71109316|NCT04005586|141724170|OTHER|The comparison was made by descriptive statistics.||||||||||||||||Two different historical controls implanted under NCT01496066 were used.|The LAL treatment group had a mean MRCYL of -0.14 (+/- 0.21D) compared to -0.33 (+/- 0.29D) and -0.40 (+/- 0.36D) for the LAL historical control group and the monofocal IOL historical control group in NCT01496066 respectively.|||
71109317|NCT04005586|141724171|OTHER|The comparison was made by descriptive statistics.||||||||||||||||Two different historical controls implanted under NCT01496066 were used.|The LAL treatment group MRCYL change from baseline was 0.36 (+/- 0.21D) compared to 0.17 (+/- 0.29D) and 0.10 (+/- 0.36D) for the LAL historical control group and the monofocal IOL historical control group in NCT01496066, respectively.|||
71109318|NCT04016714|141724197|OTHER||Difference in percentage vs Prevenar 13™|-5.5|||=|0.05|TWO_SIDED|95.0|-11.0|0.0|||Miettinen & Nurminen method|||Injection-site erythema||0.0|-11.0|= 0.050
71109319|NCT04016714|141724197|OTHER||Difference in percentage vs Prevenar 13™|-2.1|||=|0.46|TWO_SIDED|95.0|-7.7|3.5|||Miettinen & Nurminen method|||Injection-site induration||3.5|-7.7|= 0.460
71109320|NCT04016714|141724197|OTHER||Difference in percentage vs Prevenar 13™|3.4|||=|0.225|TWO_SIDED|95.0|-2.1|8.9|||Miettinen & Nurminen method|||Injection-site pain||8.9|-2.1|= 0.225
71109321|NCT04016714|141724197|OTHER||Difference in percentage vs Prevenar 13™|2.3|||=|0.43|TWO_SIDED|95.0|-3.4|7.9|||Miettinen & Nurminen method|||Injection-site swelling||7.9|-3.4|= 0.430
71109322|NCT04016714|141724198|OTHER||Difference in percentage vs Prevenar 13™|-3.5|||=|0.229|TWO_SIDED|95.0|-9.1|2.2|||Miettinen & Nurminen method|||Decreased appetite||2.2|-9.1|= 0.229
71109323|NCT04016714|141724198|OTHER||Difference in percentage vs Prevenar 13™|2.2|||=|0.077|TWO_SIDED|95.0|-0.2|4.7|||Miettinen & Nurminen method|||Irritability||4.7|-0.2|= 0.077
71109324|NCT04016714|141724198|OTHER||Difference in percentage vs Prevenar 13™|-0.6|||=|0.793|TWO_SIDED|95.0|-5.4|4.1|||Miettinen & Nurminen method|||Somnolence||4.1|-5.4|= 0.793
70935576|NCT00910962|141372071|SUPERIORITY||test to reference ratio|0.73||||0.03|TWO_SIDED|95.0|0.55|0.96|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 12||0.96|0.55|0.03
70935577|NCT00910962|141372071|SUPERIORITY||test to reference ratio|0.81||||0.14|TWO_SIDED|95.0|0.61|1.07|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 12||1.07|0.61|0.14
70935578|NCT00910962|141372071|SUPERIORITY||test to reference ratio|0.76||||0.04|TWO_SIDED|95.0|0.6|0.98|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 12||0.98|0.60|0.04
70935579|NCT00910962|141372072|SUPERIORITY||Mean Difference (Final Values)|-1.92||||0.254|TWO_SIDED|95.0|-5.25|1.41|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Day 3-5 (visit 1)||1.41|-5.25|0.254
70935580|NCT00910962|141372072|SUPERIORITY||Mean Difference (Final Values)|-2.84||||0.106|TWO_SIDED|95.0|-6.29|0.62|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Day 3-5 (visit 1)||0.62|-6.29|0.106
70935581|NCT00910962|141372072|SUPERIORITY||Mean Difference (Final Values)|-2.38||||0.126|TWO_SIDED|95.0|-5.44|0.69|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Day 3-5 (visit 1)||0.69|-5.44|0.126
70935582|NCT00910962|141372072|SUPERIORITY||Mean Difference (Final Values)|-1.91||||0.184|TWO_SIDED|95.0|-4.74|0.92|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 12||0.92|-4.74|0.184
70935583|NCT00910962|141372072|SUPERIORITY||Mean Difference (Final Values)|-2.47||||0.093|TWO_SIDED|95.0|-5.37|0.43|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 12||0.43|-5.37|0.093
70935584|NCT00910962|141372072|SUPERIORITY||Mean Difference (Final Values)|-2.19||||0.096|TWO_SIDED|95.0|-4.78|0.4|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 12||0.40|-4.78|0.096
70935585|NCT00910962|141372073|SUPERIORITY||Mean Difference (Final Values)|4.22||||0.124|TWO_SIDED|95.0|-1.18|9.62|||Repeated measures ANCOVA|||||9.62|-1.18|0.124
71109325|NCT04016714|141724198|OTHER||Difference in percentage vs Prevenar 13™|-4.6|||=|0.045|TWO_SIDED|95.0|-9.1|-0.1|||Miettinen & Nurminen method|||Urticaria||-0.1|-9.1|= 0.045
70935586|NCT00910962|141372073|SUPERIORITY||Mean Difference (Final Values)|6.05||||0.029|TWO_SIDED|95.0|0.63|11.47|||Repeated measures ANCOVA|||||11.47|0.63|0.029
70935587|NCT00910962|141372073|SUPERIORITY||Mean Difference (Final Values)|5.14||||0.039|TWO_SIDED|95.0|0.28|10.0|||Repeated measures ANCOVA|||||10.00|0.28|0.039
70935588|NCT00910962|141372074|SUPERIORITY||Mean Difference (Final Values)|-21.53||||0.025|TWO_SIDED|95.0|-40.27|-2.79|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For LVEDV||-2.79|-40.27|0.025
70935589|NCT00910962|141372074|SUPERIORITY||Mean Difference (Final Values)|-18.65||||0.053|TWO_SIDED|95.0|-37.58|0.29|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For LVEDV||0.29|-37.58|0.053
70935590|NCT00910962|141372074|SUPERIORITY||Mean Difference (Final Values)|-20.09||||0.021|TWO_SIDED|95.0|-37.01|-3.18|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For LVEDV||-3.18|-37.01|0.021
70935591|NCT00910962|141372074|SUPERIORITY||Mean Difference (Final Values)|-15.82||||0.024|TWO_SIDED|95.0|-29.51|-2.14|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For LVESV||-2.14|-29.51|0.024
70935592|NCT00910962|141372074|SUPERIORITY||Mean Difference (Final Values)|-17.22||||0.016|TWO_SIDED|95.0|-31.14|-3.29|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For LVESV||-3.29|-31.14|0.016
70935593|NCT00910962|141372074|SUPERIORITY||Mean Difference (Final Values)|-16.52||||0.01|TWO_SIDED|95.0|-28.91|-4.13|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For LVESV||-4.13|-28.91|0.010
70935594|NCT00910962|141372075|SUPERIORITY||Mean Difference (Final Values)|-22.21||||0.109|TWO_SIDED|95.0|-49.51|5.09|||Repeated measures ANCOVA|||||5.09|-49.51|0.109
70935595|NCT00910962|141372075|SUPERIORITY||Mean Difference (Final Values)|-7.13||||0.614|TWO_SIDED|95.0|-35.22|20.96|||Repeated measures ANCOVA|||||20.96|-35.22|0.614
70935596|NCT00910962|141372075|SUPERIORITY||Mean Difference (Final Values)|-14.67||||0.243|TWO_SIDED|95.0|-39.52|10.18|||Repeated measures ANCOVA|||||10.18|-39.52|0.243
70935597|NCT00910962|141372076|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.023|TWO_SIDED|95.0|-0.44|-0.03|||Repeated measures ANCOVA|||||-0.03|-0.44|0.023
70935598|NCT00910962|141372076|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.021|TWO_SIDED|95.0|-0.45|-0.04|||Repeated measures ANCOVA|||||-0.04|-0.45|0.021
70935599|NCT00910962|141372076|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.011|TWO_SIDED|95.0|-0.42|-0.06|||Repeated measures ANCOVA|||||-0.06|-0.42|0.011
70935600|NCT00910962|141372077|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.137|TWO_SIDED|95.0|-0.26|0.04|||Repeated measures ANCOVA|||||0.04|-0.26|0.137
70935601|NCT00910962|141372077|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.036|TWO_SIDED|95.0|-0.32|-0.01|||Repeated measures ANCOVA|||||-0.01|-0.32|0.036
70935602|NCT00910962|141372077|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.047|TWO_SIDED|95.0|-0.28|0.0|||Repeated measures ANCOVA|||||-0.00|-0.28|0.047
70935603|NCT00923078|141372078|OTHER||Mean Difference (Net)|2.2|STANDARD_ERROR_OF_MEAN|1.02|<|0.05|TWO_SIDED|95.0|0.17|4.23|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||4.23|0.17|<0.05
70935604|NCT00923078|141372078|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.72|STANDARD_ERROR_OF_MEAN|1.02||0.48|TWO_SIDED|95.0|-2.75|1.31|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.31|-2.75|0.48
71109326|NCT04016714|141724199|OTHER||Difference in percentage vs Prevenar 13™|0.0|||||TWO_SIDED|95.0|-0.9|0.9||||||Vaccine-related SAEs||0.9|-0.9|
70935605|NCT00923078|141372078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.92|STANDARD_ERROR_OF_MEAN|1.02|<|0.01|TWO_SIDED|95.0|-4.95|-0.9|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||-0.90|-4.95|<0.01
70935606|NCT00923078|141372079|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.67|STANDARD_ERROR_OF_MEAN|0.295|<|0.05|TWO_SIDED|95.0|0.08|1.25|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.25|0.08|<0.05
70935607|NCT00923078|141372079|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.51|STANDARD_ERROR_OF_MEAN|0.295||0.09|TWO_SIDED|95.0|-0.08|1.09|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.09|-0.08|0.09
70935608|NCT00923078|141372079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.295||0.59|TWO_SIDED|95.0|-0.75|0.43|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||0.43|-0.75|0.59
70935609|NCT00923078|141372080|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.03|STANDARD_ERROR_OF_MEAN|0.75|<|0.01|TWO_SIDED|95.0|-3.53|-0.52||Post-test scores following Auditory Cognitive Training as compared to baseline, tested at alpha = 0.05 (uncorrected).|Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||-0.52|-3.53|<0.01
70935610|NCT00923078|141372080|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.45|STANDARD_ERROR_OF_MEAN|0.75||0.01|TWO_SIDED|95.0|-3.95|-0.94||Post-test scores following Visual Cognitive Training as compared to baseline, tested at alpha = 0.05 (uncorrected).|Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||-0.94|-3.95|0.01
71026368|NCT00992407|141560245|NON_INFERIORITY_OR_EQUIVALENCE|80% of power and 0.05 of significance level was used|Mean Difference (Final Values)|-0.61||||0.8595|TWO_SIDED|95.0|-7.5|6.3|||t-test, 2 sided|||Change from Baseline in Personal and Social Performance (PSP) Scale Score at Week 52||6.3|-7.5|0.8595
71026369|NCT00992407|141560246|NON_INFERIORITY_OR_EQUIVALENCE|80% of power and 0.05 of significance level was used|Mean Difference (Final Values)|1.29||||0.8118|TWO_SIDED|95.0|-9.6|12.2|||t-test, 2 sided|||Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Score at Week 52||12.2|-9.6|0.8118
71026370|NCT00992407|141560255|NON_INFERIORITY_OR_EQUIVALENCE|80% of power and 0.05 of significance level was used|Mean Difference (Final Values)|10.0||||0.1768|TWO_SIDED|95.0|-4.8|24.8|||Student's t-test|||Change from Baseline in Psychosocial Well-being Index (PWI) Score at Week 52||24.8|-4.8|0.1768
71026371|NCT00992407|141560256|NON_INFERIORITY_OR_EQUIVALENCE|80% of power and 0.05 of significance level was used|Mean Difference (Final Values)|-0.33||||0.9569|TWO_SIDED|95.0|-12.8|12.2|||Student's t-test|||||12.2|-12.8|0.9569
71026372|NCT00992407|141560257|NON_INFERIORITY_OR_EQUIVALENCE|80% of power and 0.05 of significance level was used|Mean Difference (Final Values)|0.58||||0.5294|TWO_SIDED|95.0|-5.5|2.9|||t-test, 2 sided|||||2.9|-5.5|0.5294
71026373|NCT02398188|141560267|SUPERIORITY|||||||0.397|||||||Cochran-Mantel-Haenszel|||||||0.397
71026374|NCT02398188|141560268|SUPERIORITY|||||||0.379|||||||Cochran-Mantel-Haenszel|||||||0.379
71059171|NCT05736861|141625154|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.78|1.25|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.25|0.78|
71059172|NCT05736861|141625154|OTHER||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.86|1.43|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.43|0.86|
71059173|NCT05736861|141625154|OTHER||Odds Ratio (OR)|0.86|||||TWO_SIDED|95.0|0.66|1.12|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.12|0.66|
71059174|NCT05736861|141625155|OTHER||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.87|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.35|0.87|
71077965|NCT01153009|141664427|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|2.419||0.797|TWO_SIDED|95.0|-5.4|4.15|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||4.15|-5.40|0.797
71109327|NCT04016714|141724200|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% confidence interval (CI) for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|-2.2|||<|0.001|TWO_SIDED|95.0|-4.3|-0.6|||Miettinen & Nurminen method|||Serotype 1||-0.6|-4.3|< 0.001
70852209|NCT03615040|141192861|SUPERIORITY|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||sputum purulence colour card Week 36||||0.82
71059175|NCT05736861|141625155|OTHER||Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|0.96|1.57|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.57|0.96|
71059176|NCT05736861|141625155|OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.92|1.54|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.54|0.92|
71059177|NCT05736861|141625155|OTHER||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.71|1.18|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.18|0.71|
71059178|NCT05736861|141625156|OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.97|1.47|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.47|0.97|
71059179|NCT05736861|141625156|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.84|1.33|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.33|0.84|
71059180|NCT05736861|141625156|OTHER||Odds Ratio (OR)|1.21|||||TWO_SIDED|95.0|0.95|1.55|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.55|0.95|
71059181|NCT05736861|141625156|OTHER||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.73|1.19|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.19|0.73|
71059182|NCT05736861|141625157|OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.86|1.26|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.26|0.86|
71059183|NCT05736861|141625157|OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.85|1.29|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.29|0.85|
71059184|NCT05736861|141625157|OTHER||Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.85|1.34|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.34|0.85|
71059185|NCT05736861|141625157|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.8|1.28|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.28|0.80|
71059186|NCT05736861|141625158|OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.88|1.27|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.27|0.88|
71059187|NCT05736861|141625158|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.79|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.14|0.79|
71059188|NCT05736861|141625158|OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.75|1.09|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.09|0.75|
71059189|NCT05736861|141625158|OTHER||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.93|1.36|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.36|0.93|
71059190|NCT05736861|141625159|SUPERIORITY||Difference in model estimate time unwell|-0.49|||||TWO_SIDED|95.0|-0.82|-0.15|||||The interval is a highest-density credible interval.|||-0.15|-0.82|
71059191|NCT05736861|141625160|SUPERIORITY||Difference in model estimated means|0.59|||||TWO_SIDED|95.0|0.18|0.99|||||The interval is a highest-density credible interval.|Analysis is exploratory. No hypothesis test or decision rule was evaluated.||0.99|0.18|
71077966|NCT01153009|141664427|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.05|STANDARD_ERROR_OF_MEAN|2.278||0.078|TWO_SIDED|95.0|-8.54|0.45|||Mixed model for repeated mesurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||0.45|-8.54|0.078
71077967|NCT01153009|141664428|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.053||||0.845|TWO_SIDED|95.0|0.625|1.775|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.775|0.625|0.845
71077968|NCT01153009|141664428|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.192||||0.503|TWO_SIDED|95.0|0.713|1.994|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.994|0.713|0.503
71026375|NCT00782509|141560270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.116|0.185|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.185|0.116|<0.0001
71026376|NCT00782509|141560270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.11|0.177|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.177|0.110|<0.0001
71026377|NCT00782509|141560271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.019||0.0116||95.0|0.011|0.084|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.084|0.011|0.0116
71026378|NCT00782509|141560271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.019||0.0095||95.0|0.012|0.085|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.085|0.012|0.0095
71026379|NCT00782509|141560272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.057|0.162|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 5 mcg qd minus Placebo|||0.162|0.057|<0.0001
71026380|NCT00782509|141560272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.027||0.0011||95.0|0.036|0.143|||Mixed Models Analysis|Treatment, tiotropium stratum and baseline as fixed effects|Olo 10 mcg qd minus Placebo|||0.143|0.036|0.0011
71026381|NCT00782509|141560273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.131|0.197|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.197|0.131|<0.0001
71026382|NCT00782509|141560273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.138|0.204|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.204|0.138|<0.0001
71077969|NCT01153009|141664428|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.098||||0.728|TWO_SIDED|95.0|0.648|1.86|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.860|0.648|0.728
71077970|NCT01153009|141664429|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|1.111||0.962|TWO_SIDED|95.0|-2.24|2.13|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||2.13|-2.24|0.962
71026383|NCT00782509|141560274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.163|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.13|0.197|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.197|0.130|<0.0001
71026384|NCT00782509|141560274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.119|0.186|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.186|0.119|<0.0001
71026385|NCT00782509|141560275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.135|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.203|0.135|<0.0001
71026386|NCT00782509|141560275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.127|0.195|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.195|0.127|<0.0001
71077971|NCT01153009|141664429|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|1.103||0.427|TWO_SIDED|95.0|-3.05|1.29|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||1.29|-3.05|0.427
71026387|NCT00782509|141560276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.131|0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.200|0.131|<0.0001
71026388|NCT00782509|141560276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.102|0.171|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.171|0.102|<0.0001
71029289|NCT03676803|141566072|OTHER||Mean Difference (Final Values)|8.7||||0.097|TWO_SIDED|||||p\<0.05 was defined as significant.|ANOVA|||Comparison was made to 2 weeks minus baseline changes in phylum Bacteroidetes abundance between groups.||||0.097
71029290|NCT03676803|141566073|OTHER||Mean Difference (Final Values)|86.0||||0.49|TWO_SIDED||||||t-test, 2 sided|||Comparison was made to 2 weeks minus baseline in mixed spices intervention group||||0.49
71029291|NCT03676803|141566073|OTHER||Mean Difference (Final Values)|55.7||||0.53|TWO_SIDED||||||t-test, 2 sided|||Comparison was made to 2 weeks minus baseline in placebo group||||0.53
71029292|NCT01355081|141566075|SUPERIORITY_OR_OTHER||Least square means difference|-2.03|STANDARD_ERROR_OF_MEAN|1.241||0.1031|TWO_SIDED|95.0|-4.467|0.413|||ANCOVA|Change in MADRS total score as a dependent variable, treatment as a fixed effect and the baseline MADRS total score as a covariate.||||0.413|-4.467|0.1031
71029293|NCT01355081|141566075|SUPERIORITY_OR_OTHER||Least square mean difference|-1.04|STANDARD_ERROR_OF_MEAN|1.233||0.4008|TWO_SIDED|95.0|-3.461|1.387|||ANCOVA|Change in MADRS total score as a dependent variable, treatment as a fixed effect and the baseline MADRS total score as a covariate.||||1.387|-3.461|0.4008
70852210|NCT03615040|141192861|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||sputum purulence colour card Week 48||||0.95
71026389|NCT00782509|141560277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.127|0.196|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.196|0.127|<0.0001
70852211|NCT03615040|141192862|SUPERIORITY||Mean Difference (Final Values)|9.06||||0.069|TWO_SIDED|95.0|-0.83|18.97|||ANCOVA|||Pre BD FEV1/FVC ratio: Analysis of covariance (ANCOVA) adjusting for the baseline value||18.97|-0.83|0.069
71026390|NCT00782509|141560277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001||95.0|0.123|0.193|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.193|0.123|<0.0001
71026391|NCT00782509|141560278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.018||0.0043||95.0|0.017|0.089|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.089|0.017|0.0043
71026392|NCT00782509|141560278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.018||0.0005||95.0|0.028|0.101|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.101|0.028|0.0005
71026393|NCT00782509|141560279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.037|0.11|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.110|0.037|<0.0001
71026394|NCT00782509|141560279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.049|0.121|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.121|0.049|<0.0001
71026395|NCT00782509|141560280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.019||0.0002||95.0|0.032|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.106|0.032|0.0002
71059192|NCT00879255|141625161|NON_INFERIORITY_OR_EQUIVALENCE|We used a noninferiority design to test the hypothesis that VTC is noninferior to in-person treatment delivery. The noninferiority margin was determined to be 10 CAPS points. We analyzed means differences in CAPS scores between the two treatment conditions (VTC minus in-person) with positive values indicating greater reductions in VTC condition. Power was estimated to be 90% with alpha = .20, and a between-group difference equaling an effect size of d = .50 (estimated 10 CAPS points).|Mean Difference (Final Values)|-4.75|||>|0.05|TWO_SIDED|95.0|-11.92|2.42||"The noninferiority margin is the maximum clinically meaningful amount by which VTC can be worse than the in-person delivery to allow for a conclusion of noninferiority (a priori set to 10 CAPS points)."|noninferiority analysis|We hypothesized that VTC is noninferior to in-person condition, which is supported if upper limit of 95% CI is less than preset noninferiority margin.|The noninferiority hypothesis would be supported if the 95% Confidence Interval of the difference in CAPS scores between the 2 conditions (VTC minus in-person scores) is less than the present noninferiority margin (10 CAPS points).|||2.42|-11.92|> .05
70935611|NCT00923078|141372080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.75||0.58|TWO_SIDED|95.0|-1.93|1.08||Post-test scores following Auditory Cognitive Training as compared to Visual Cognitive Training, tested at alpha = 0.05 (uncorrected).|Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.08|-1.93|0.58
71026396|NCT00782509|141560280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.019||0.0186||95.0|0.007|0.081|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.081|0.007|0.0186
71077972|NCT01153009|141664429|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.99|STANDARD_ERROR_OF_MEAN|1.123||0.078|TWO_SIDED|95.0|-4.19|0.22|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||0.22|-4.19|0.078
71026397|NCT00782509|141560281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.019||0.0003||95.0|0.032|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.106|0.032|0.0003
71026398|NCT00782509|141560281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.019||0.002||95.0|0.021|0.095|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.095|0.021|0.0020
71026399|NCT00782509|141560282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.019||0.0024||95.0|0.02|0.095|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.095|0.020|0.0024
71026400|NCT00782509|141560282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.027|STANDARD_ERROR_OF_MEAN|0.019||0.1614||95.0|-0.011|0.064|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.064|-0.011|0.1614
71026401|NCT00782509|141560283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|STANDARD_ERROR_OF_MEAN|0.019||0.0012||95.0|0.025|0.099|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.099|0.025|0.0012
71026402|NCT00782509|141560283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.072|STANDARD_ERROR_OF_MEAN|0.019||0.0002||95.0|0.034|0.109|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.109|0.034|0.0002
71059193|NCT00879255|141625162|NON_INFERIORITY_OR_EQUIVALENCE|We used a noninferiority design to test the hypothesis that VTC is noninferior to in-person treatment delivery. The noninferiority margin was determined to be 10 CAPS points. We analyzed means differences in CAPS scores between the two treatment conditions (VTC minus in-person) with positive values indicating greater reductions in VTC condition. Power was estimated to be 90% with alpha = .20, and a between-group difference equaling an effect size of d = .50 (estimated 10 CAPS points).|Mean Difference (Final Values)|-4.76|||>|0.05|TWO_SIDED|95.0|-11.65|2.13||"The noninferiority margin is the maximum clinically meaningful amount by which VTC can be worse than the in-person delivery to allow for a conclusion of noninferiority (a priori set to 10 CAPS points)."|noninferiority design|We hypothesized that VTC is noninferior to in-person condition, which is supported if upper limit of 95% CI is less than preset noninferiority margin.|The noninferiority hypothesis would be supported if the 95% Confidence Interval of the difference in CAPS scores between the 2 conditions (VTC minus in-person scores) is less than the present noninferiority margin (10 CAPS points).|||2.13|-11.65|> .05
71059194|NCT00879255|141625163|NON_INFERIORITY_OR_EQUIVALENCE|We used a noninferiority design to test the hypothesis that VTC is noninferior to in-person treatment delivery. The noninferiority margin was determined to be 10 CAPS points. We analyzed means differences in CAPS scores between the two treatment conditions (VTC minus in-person) with positive values indicating greater reductions in VTC condition. Power was estimated to be 90% with alpha = .20, and a between-group difference equaling an effect size of d = .50 (estimated 10 CAPS points).|Mean Difference (Final Values)|-5.56|||>|0.05|TWO_SIDED|95.0|-16.26|5.14||"The noninferiority margin is the maximum clinically meaningful amount by which VTC can be worse than the in-person delivery to allow for a conclusion of noninferiority (a priori set to 10 CAPS points)."|noninferiority test|We hypothesized that VTC is noninferior to in-person condition, which is supported if upper limit of 95% CI is less than preset noninferiority margin.|The noninferiority hypothesis would be supported if the 95% Confidence Interval of the difference in CAPS scores between the 2 conditions (VTC minus in-person scores) is less than the present noninferiority margin (10 CAPS points).|||5.14|-16.26|> .05
71059195|NCT03860974|141625164|NON_INFERIORITY|"We tested the non-inferiority of serratus block compared with PVB using the 95% CI associated with the Wilcoxon-Mann-Whitney test with continuity correction. If the lower limit of the 95% CI for median average PACU pain scores was greater than -1.25 , we would conclude non-inferiority. The non-inferiority of serratus blocks with regard to opioid consumption was similarly tested to a predefined non-inferiority margin of 2 mg intravenous morphine equivalents."|Median Difference (Final Values)|4.0||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.001
71077973|NCT00703326|141664445|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.077|TWO_SIDED|95.0|0.75|1.01|||Stratified Log Rank (SLR)|SLR used Interactive Web Response System (IWRS) factors: prior taxane therapy, visceral metastasis, hormone receptor status and geographical regions.|HR with 95% confidence interval (CI) was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors.|||1.01|0.75|0.077
71026403|NCT00782509|141560284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.019||0.0004||95.0|0.031|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.106|0.031|0.0004
71026404|NCT00782509|141560284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.071|STANDARD_ERROR_OF_MEAN|0.019||0.0002||95.0|0.033|0.108|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.108|0.033|0.0002
71026405|NCT00782509|141560285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.168|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.132|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.203|0.132|<0.0001
71026406|NCT00782509|141560285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.177|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.142|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.212|0.142|<0.0001
71078851|NCT01964716|141665735|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|0.96|||||TWO_SIDED|97.5|0.75|1.24||||||Serotype 14: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.24|0.75|
71026407|NCT00782509|141560286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.119|0.19|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.190|0.119|<0.0001
71026408|NCT00782509|141560286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.111|0.182|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.182|0.111|<0.0001
71026409|NCT00782509|141560287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.136|0.209|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.209|0.136|<0.0001
71026410|NCT00782509|141560287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.13|0.202|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.202|0.130|<0.0001
71109328|NCT04016714|141724200|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|10.5|||<|0.001|TWO_SIDED|95.0|6.6|14.6|||Miettinen & Nurminen method|||Serotype 3||14.6|6.6|< 0.001
71109329|NCT04016714|141724200|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|-1.9|||<|0.001|TWO_SIDED|95.0|-4.0|0.0|||Miettinen & Nurminen method|||Serotype 4||0.0|-4.0|< 0.001
71109330|NCT04016714|141724200|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.4|0.8|||Miettinen & Nurminen method|||Serotype 5||0.8|-1.4|< 0.001
71109331|NCT04016714|141724200|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.5|1.0|||Miettinen & Nurminen method|||Serotype 6A||1.0|-1.5|< 0.001
71109332|NCT04016714|141724200|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-1.2|1.5|||Miettinen & Nurminen method|||Serotype 6B||1.5|-1.2|< 0.001
71109333|NCT04016714|141724200|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|0.4|||<|0.001|TWO_SIDED|95.0|-0.4|1.4|||Miettinen & Nurminen method|||Serotype 7F||1.4|-0.4|< 0.001
71109334|NCT04016714|141724200|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.8|1.2|||Miettinen & Nurminen method|||Serotype 9V||1.2|-0.8|< 0.001
71109335|NCT04016714|141724200|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|-0.4|||<|0.001|TWO_SIDED|95.0|-1.7|0.7|||Miettinen & Nurminen method|||Serotype 14||0.7|-1.7|< 0.001
70935612|NCT00923078|141372081|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.92|STANDARD_ERROR_OF_MEAN|1.55||0.06|TWO_SIDED|95.0|-6.02|0.18|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||0.18|-6.02|0.06
70935613|NCT00923078|141372081|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.24|STANDARD_ERROR_OF_MEAN|1.55|<|0.05|TWO_SIDED|95.0|-6.34|-0.14|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||-0.14|-6.34|< 0.05
71109336|NCT04016714|141724200|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|0.4|||<|0.001|TWO_SIDED|95.0|-0.6|1.5|||Miettinen & Nurminen method|||Serotype 18C||1.5|-0.6|< 0.001
71109337|NCT04016714|141724200|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.3|0.7|||Miettinen & Nurminen method|||Serotype 19A||0.7|-1.3|< 0.001
71109338|NCT04016714|141724200|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.8|1.2|||Miettinen & Nurminen method|||Serotype 19F||1.2|-0.8|< 0.001
71109339|NCT04016714|141724200|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|0.9|||<|0.001|TWO_SIDED|95.0|-1.2|3.0|||Miettinen & Nurminen method|||Serotype 23F||3.0|-1.2|< 0.001
71109340|NCT04016714|141724200|SUPERIORITY|For the 2 serotypes unique to V114, a conclusion of superiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>10 percentage points (1-sided p-value \<0.025).|Percentage point difference|94.0|||<|0.001|TWO_SIDED|95.0|91.6|95.8|||Miettinen & Nurminen method|||Serotype 22F||95.8|91.6|< 0.001
71109341|NCT04016714|141724200|SUPERIORITY|For the 2 serotypes unique to V114, a conclusion of superiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>10 percentage points (1-sided p-value \<0.025).|Percentage point difference|97.2|||<|0.001|TWO_SIDED|95.0|95.4|98.4|||Miettinen & Nurminen method|||Serotype 33F||98.4|95.4|< 0.001
70935614|NCT00923078|141372081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|1.55||0.84|TWO_SIDED|95.0|-3.42|2.78|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||2.78|-3.42|0.84
71026411|NCT00782509|141560288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.108|0.18|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.180|0.108|<0.0001
71026412|NCT00782509|141560288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.094|0.166|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.166|0.094|<0.0001
71026413|NCT00782509|141560289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.128|0.201|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.201|0.128|<0.0001
71026414|NCT00782509|141560289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.098|0.171|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.171|0.098|<0.0001
71026415|NCT00782509|141560290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.118|0.192|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.192|0.118|<0.0001
71026416|NCT00782509|141560290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.12|0.194|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.194|0.120|<0.0001
71026417|NCT00782509|141560291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.331|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.263|0.399|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.399|0.263|<0.0001
71026418|NCT00782509|141560291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.333|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.265|0.4|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.400|0.265|<0.0001
71059196|NCT01499095|141625188|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"Stepwise closed testing approach was to assess non-inferiority and superiority sequentially:~1. Non-inferiority of HOE901-U300 vs Lantus: Upper bound of two-sided 95% confidence interval (CI) of difference between HOE901-U300 and Lantus on mITT population is \<0.4%.~2. Superiority (only if non-inferiority has been demonstrated): Upper bound of two-sided 95% CI for difference in mean change in HbA1c from baseline to endpoint between HOE901-U300 and Lantus on mITT population is \<0."|Least Squares (LS) Mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.066|||TWO_SIDED|95.0|-0.139|0.119||||||Analysis was performed using an analysis of covariance (ANCOVA) model with treatment, strata of screening HbA1c (\<8.0 and \>=8.0%), and country as fixed effects and using the HbA1c baseline value as a covariate.||0.119|-0.139|
71026419|NCT00782509|141560292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.242|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.174|0.31|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.310|0.174|<0.0001
71026420|NCT00782509|141560292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.159|0.294|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.294|0.159|<0.0001
71026421|NCT00782509|141560293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.263|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.195|0.332|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.332|0.195|<0.0001
71059197|NCT01499095|141625189|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.77||||0.038|TWO_SIDED|95.0|0.61|0.99|||Cochran-Mantel-Haenszel|||A one-sided test (at alpha=0.025) for superiority of HOE901-U300 over Lantus was to be performed in case the non-inferiority of HOE901-U300 vs Lantus for the primary endpoint was demonstrated. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with treatment as a factor and stratified on strata of screening HbA1c (\<8.0 and \>=8.0%).||0.99|0.61|0.0380
71026422|NCT00782509|141560293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.246|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.178|0.315|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.315|0.178|<0.0001
71026423|NCT00782509|141560294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.239|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.17|0.308|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.308|0.170|<0.0001
71026424|NCT00782509|141560294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.245|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.176|0.314|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.314|0.176|<0.0001
71026425|NCT00782509|141560295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.241|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.171|0.311|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.311|0.171|<0.0001
71109342|NCT04016714|141724201|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.58|||<|0.001|TWO_SIDED|95.0|0.54|0.63|||t-test, 1 sided|||Serotype 1||0.63|0.54|< 0.001
71026426|NCT00782509|141560295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.219|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.15|0.289|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.289|0.150|<0.0001
71026427|NCT00782509|141560296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.217|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.147|0.288|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.288|0.147|<0.0001
71026428|NCT00782509|141560296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.148|0.288|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.288|0.148|<0.0001
71026429|NCT00782509|141560297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.037||0.104||95.0|-0.012|0.131|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.131|-0.012|0.1040
71026430|NCT00782509|141560297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.036||0.0172||95.0|0.015|0.158|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.158|0.015|0.0172
71026431|NCT00782509|141560298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.037||0.0106||95.0|0.022|0.166|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.166|0.022|0.0106
71026432|NCT00782509|141560298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.037||0.0013||95.0|0.046|0.19|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.190|0.046|0.0013
71059198|NCT01499095|141625190|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.201||0.8279|TWO_SIDED|95.0|-0.438|0.35|||ANCOVA|||Change in pre-injection SMPG was analysed using an ANCOVA model with treatment, strata of screening HbA1c (\<8.0 and \>=8.0%), and country as fixed effects and using the pre-injection SMPG baseline value as a covariate. A test for superiority of HOE901-U300 over Lantus was to be performed one-sided at level alpha = 0.025 if previous analysis for nocturnal hypoglycaemia was significant.||0.350|-0.438|0.8279
71059199|NCT01499095|141625199|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.142|||TWO_SIDED|95.0|-0.152|0.415||||||Analysis was performed using Analysis of covariance (ANCOVA) model with treatment regimen and country as fixed effects and baseline (Month 6) HbA1c value as a covariate.||0.415|-0.152|
71109343|NCT04016714|141724201|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|1.31|||<|0.001|TWO_SIDED|95.0|1.2|1.43|||t-test, 1 sided|||Serotype 3||1.43|1.20|< 0.001
71026433|NCT00782509|141560299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032|STANDARD_ERROR_OF_MEAN|0.037||0.3821||95.0|-0.04|0.105|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.105|-0.040|0.3821
71026434|NCT00782509|141560299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.037||0.1917||95.0|-0.024|0.12|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.120|-0.024|0.1917
71026435|NCT00782509|141560300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.037||0.1808||95.0|-0.023|0.123|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.123|-0.023|0.1808
71059200|NCT01130532|141625223|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71059201|NCT01130532|141625223|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71059202|NCT01130532|141625224|SUPERIORITY_OR_OTHER||LS Mean Difference|6.1|STANDARD_ERROR_OF_MEAN|0.69|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71059203|NCT01130532|141625224|SUPERIORITY_OR_OTHER||LS Mean Difference|6.2|STANDARD_ERROR_OF_MEAN|0.68|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71026436|NCT00782509|141560300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.037||0.37||95.0|-0.039|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.106|-0.039|0.3700
71059204|NCT01130532|141625225|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|0.29|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71109344|NCT04016714|141724201|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.7|||<|0.001|TWO_SIDED|95.0|0.63|0.78|||t-test, 1 sided|||Serotype 4||0.78|0.63|< 0.001
70935615|NCT00923078|141372082|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.62|STANDARD_ERROR_OF_MEAN|1.04||0.55|TWO_SIDED|95.0|-1.45|2.69|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||2.69|-1.45|0.55
71026437|NCT00782509|141560301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.037||0.2312||95.0|-0.029|0.118|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.118|-0.029|0.2312
71109345|NCT04016714|141724201|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.62|||<|0.001|TWO_SIDED|95.0|0.56|0.68|||t-test, 1 sided|||Serotype 5||0.68|0.56|< 0.001
70941717|NCT04748445|141383935|OTHER||Slope|-0.0005071|STANDARD_ERROR_OF_MEAN|7.593||0.5055|TWO_SIDED|90.0|-0.001765|0.0007512|||Mixed Models Analysis|||EE\_MFCC 1st order delta 07 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0007512|-0.001765|0.5055
71026438|NCT00782509|141560301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.037||0.0596||95.0|-0.003|0.144|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.144|-0.003|0.0596
71026439|NCT00782509|141560302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038|STANDARD_ERROR_OF_MEAN|0.037||0.311||95.0|-0.036|0.111|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.111|-0.036|0.3110
71026440|NCT00782509|141560302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.038||0.9426||95.0|-0.076|0.071|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.071|-0.076|0.9426
71026441|NCT00782509|141560303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.038||0.268||95.0|-0.032|0.115|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.115|-0.032|0.2680
71026442|NCT00782509|141560303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.038||0.0662||95.0|-0.005|0.143|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.143|-0.005|0.0662
71059205|NCT01130532|141625225|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|0.29|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71059206|NCT01130532|141625226|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.23|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71059207|NCT01130532|141625226|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.22|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71059208|NCT01130532|141625227|SUPERIORITY_OR_OTHER||LS Mean Difference|10.4|STANDARD_ERROR_OF_MEAN|2.28|<|0.001||95.0||||P-value is for Question 1. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71059209|NCT01130532|141625227|SUPERIORITY_OR_OTHER||LS Mean Difference|9.6|STANDARD_ERROR_OF_MEAN|2.26|<|0.001||95.0||||P-value is for Question 1. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71059210|NCT01130532|141625227|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3|STANDARD_ERROR_OF_MEAN|3.14|<|0.001||95.0||||P-value is for Question 2. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71059211|NCT01130532|141625227|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3|STANDARD_ERROR_OF_MEAN|3.12|<|0.001||95.0||||P-value is for Question 2. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71059212|NCT01130532|141625227|SUPERIORITY_OR_OTHER||LS Mean Difference|24.7|STANDARD_ERROR_OF_MEAN|3.53|<|0.001||95.0||||P-value is for Question 3. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71059213|NCT01130532|141625227|SUPERIORITY_OR_OTHER||LS Mean Difference|26.8|STANDARD_ERROR_OF_MEAN|3.5|<|0.001||95.0||||P-value is for Question 3. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71059214|NCT01130532|141625227|SUPERIORITY_OR_OTHER||LS Mean Difference|32.7|STANDARD_ERROR_OF_MEAN|3.82|<|0.001||95.0||||P-value is for Question 4. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71059215|NCT01130532|141625227|SUPERIORITY_OR_OTHER||LS Mean Difference|31.3|STANDARD_ERROR_OF_MEAN|3.79|<|0.001||95.0||||P-value is for Question 4. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71026443|NCT00782509|141560304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.038||0.2249||95.0|-0.028|0.12|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.120|-0.028|0.2249
71059216|NCT01130532|141625227|SUPERIORITY_OR_OTHER||LS Mean Difference|33.0|STANDARD_ERROR_OF_MEAN|3.78|<|0.001||95.0||||P-value is for Question 5. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71109346|NCT04016714|141724201|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.6|||<|0.001|TWO_SIDED|95.0|0.54|0.67|||t-test, 1 sided|||Serotype 6A||0.67|0.54|< 0.001
71109347|NCT04016714|141724201|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.89|||<|0.001|TWO_SIDED|95.0|0.79|1.0|||t-test, 1 sided|||Serotype 6B||1.00|0.79|< 0.001
71109348|NCT04016714|141724201|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.69|0.81|||t-test, 1 sided|||Serotype 7F||0.81|0.69|< 0.001
71109349|NCT04016714|141724201|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.7|||<|0.001|TWO_SIDED|95.0|0.64|0.76|||t-test, 1 sided|||Serotype 9V||0.76|0.64|< 0.001
71109350|NCT04016714|141724201|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.78|||<|0.001|TWO_SIDED|95.0|0.7|0.87|||t-test, 1 sided|||Serotype 14||0.87|0.70|< 0.001
71109351|NCT04016714|141724201|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.85|||<|0.001|TWO_SIDED|95.0|0.77|0.92|||t-test, 1 sided|||Serotype 18C||0.92|0.77|< 0.001
71109352|NCT04016714|141724201|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.68|0.82|||t-test, 1 sided|||Serotype 19A||0.82|0.68|< 0.001
71109353|NCT04016714|141724201|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.72|0.87|||t-test, 1 sided|||Serotype 19F||0.87|0.72|< 0.001
71109354|NCT04016714|141724201|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.9|||<|0.001|TWO_SIDED|95.0|0.81|1.0|||t-test, 1 sided|||Serotype 23F||1.00|0.81|< 0.001
71109355|NCT04016714|141724201|SUPERIORITY|For the 2 serotypes unique to V114, a conclusion of superiority of V114 to Prevenar 13™ is based on the lower bound of the 2- sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>2.0 (1-sided p-value \<0.025).|GMC ratio|68.34|||<|0.001|TWO_SIDED|95.0|61.73|75.65|||t-test, 1 sided|||Serotype 22F||75.65|61.73|< 0.001
71026444|NCT00782509|141560304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|STANDARD_ERROR_OF_MEAN|0.038||0.0994||95.0|-0.012|0.136|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.136|-0.012|0.0994
71026445|NCT00782509|141560305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.332|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.261|0.403|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.403|0.261|<0.0001
71026446|NCT00782509|141560305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.333|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.263|0.403|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.403|0.263|<0.0001
71026447|NCT00782509|141560306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.225|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.153|0.296|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.296|0.153|<0.0001
71109356|NCT04016714|141724201|SUPERIORITY|For the 2 serotypes unique to V114, a conclusion of superiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>2.0 (1-sided p-value \<0.025).|GMC ratio|48.99|||<|0.001|TWO_SIDED|95.0|44.45|54.01|||t-test, 1 sided|||Serotype 33F||54.01|44.45|< 0.001
71109357|NCT04016714|141724202|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.6|1.0|||Miettinen & Nurminen method|||Diphtheria toxoid||1.0|-0.6|< 0.001
71026448|NCT00782509|141560306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.139|0.281|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.281|0.139|<0.0001
71109358|NCT04016714|141724202|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.6|1.0|||Miettinen & Nurminen method|||Tetanus toxoid||1.0|-0.6|< 0.001
71109359|NCT04016714|141724202|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.6|1.0|||Miettinen & Nurminen method|||Pertussis - PT||1.0|-0.6|< 0.001
71109360|NCT04016714|141724202|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.6|1.0|||Miettinen & Nurminen method|||Pertussis - FHA||1.0|-0.6|< 0.001
71026449|NCT00782509|141560307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.268|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.196|0.34|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.340|0.196|<0.0001
71026450|NCT00782509|141560307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.179|0.323|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.323|0.179|<0.0001
71026451|NCT00782509|141560308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.154|0.298|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.298|0.154|<0.0001
71026452|NCT00782509|141560308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.137|0.281|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.281|0.137|<0.0001
71026453|NCT00782509|141560309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.153|0.299|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.299|0.153|<0.0001
71026454|NCT00782509|141560309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.133|0.279|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.279|0.133|<0.0001
71026455|NCT00782509|141560310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.133|0.28|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.280|0.133|<0.0001
71026456|NCT00782509|141560310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.211|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.138|0.285|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.285|0.138|<0.0001
71026457|NCT00782509|141560311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|STANDARD_ERROR_OF_MEAN|0.047||0.0028||95.0|0.049|0.235|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 5 mcg qd minus Placebo|||0.235|0.049|0.0028
71026458|NCT00782509|141560311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.048||0.0013||95.0|0.061|0.25|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 10 mcg qd minus Placebo|||0.250|0.061|0.0013
71059217|NCT01130532|141625227|SUPERIORITY_OR_OTHER||LS Mean Difference|30.5|STANDARD_ERROR_OF_MEAN|3.75|<|0.001||95.0||||P-value is for Question 5. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71059218|NCT01130532|141625228|SUPERIORITY_OR_OTHER||LS Mean Difference|23.1|STANDARD_ERROR_OF_MEAN|2.49|<|0.001||95.0||||P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71059219|NCT01130532|141625228|SUPERIORITY_OR_OTHER||LS Mean Difference|25.4|STANDARD_ERROR_OF_MEAN|2.48|<|0.001||95.0||||P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71059220|NCT01130532|141625228|SUPERIORITY_OR_OTHER||LS Mean Difference|19.9|STANDARD_ERROR_OF_MEAN|2.36|<|0.001||95.0||||P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71059221|NCT01130532|141625228|SUPERIORITY_OR_OTHER||LS Mean Difference|20.6|STANDARD_ERROR_OF_MEAN|2.35|<|0.001||95.0||||P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71059222|NCT01130532|141625228|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3|STANDARD_ERROR_OF_MEAN|2.21|<|0.001||95.0||||P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71026459|NCT00782509|141560312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.36|STANDARD_ERROR_OF_MEAN|4.959||0.0072|TWO_SIDED|95.0|3.622|23.099|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||23.099|3.622|0.0072
71059223|NCT01130532|141625228|SUPERIORITY_OR_OTHER||LS Mean Difference|19.5|STANDARD_ERROR_OF_MEAN|2.2|<|0.001||95.0||||P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71109361|NCT04016714|141724202|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.8|1.2|||Miettinen & Nurminen method|||Pertussis - FIM 2/3||1.2|-0.8|< 0.001
71026460|NCT00782509|141560312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.934|STANDARD_ERROR_OF_MEAN|4.894|<|0.0001|TWO_SIDED|95.0|11.323|30.545|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||30.545|11.323|<0.0001
71026461|NCT00782509|141560313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.456|STANDARD_ERROR_OF_MEAN|5.201||0.0169|TWO_SIDED|95.0|2.242|22.67|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||22.670|2.242|0.0169
70935616|NCT00923078|141372082|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|1.03||0.98|TWO_SIDED|95.0|-2.02|2.07|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||2.07|-2.02|0.98
70935617|NCT00923078|141372082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|1.04||0.57|TWO_SIDED|95.0|-2.66|1.47|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.47|-2.66|0.57
70941718|NCT04748445|141383935|OTHER||Slope|0.0003067|STANDARD_ERROR_OF_MEAN|6.273||0.6257|TWO_SIDED|90.0|-0.0007328|0.001346|||Mixed Models Analysis|||EE\_MFCC 1st order delta 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001346|-0.0007328|0.6257
71059224|NCT01130532|141625228|SUPERIORITY_OR_OTHER||LS Mean Difference|26.0|STANDARD_ERROR_OF_MEAN|2.54|<|0.001||95.0||||P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71059225|NCT01130532|141625228|SUPERIORITY_OR_OTHER||LS Mean Difference|28.7|STANDARD_ERROR_OF_MEAN|2.53|<|0.001||95.0||||P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71059226|NCT01130532|141625228|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3|STANDARD_ERROR_OF_MEAN|2.65|<|0.001||95.0||||P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71059227|NCT01130532|141625228|SUPERIORITY_OR_OTHER||LS Mean Difference|20.1|STANDARD_ERROR_OF_MEAN|2.64|<|0.001||95.0||||P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71059228|NCT01130532|141625229|SUPERIORITY_OR_OTHER||LS Mean Difference|28.9|STANDARD_ERROR_OF_MEAN|2.77|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANOVA|||||||<0.001
71059229|NCT01130532|141625229|SUPERIORITY_OR_OTHER||LS Mean Difference|31.0|STANDARD_ERROR_OF_MEAN|2.76|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANOVA|||||||<0.001
71059230|NCT01130532|141625230|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.11|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71059231|NCT01130532|141625230|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.11|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71059232|NCT01130532|141625231|SUPERIORITY_OR_OTHER||LS Mean Difference|21.7|STANDARD_ERROR_OF_MEAN|2.81|<|0.001||95.0||||P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71059233|NCT01130532|141625231|SUPERIORITY_OR_OTHER||LS Mean Difference|25.2|STANDARD_ERROR_OF_MEAN|2.78|<|0.001||95.0||||P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71059234|NCT01130532|141625231|SUPERIORITY_OR_OTHER||LS Mean Difference|22.3|STANDARD_ERROR_OF_MEAN|2.46|<|0.001||95.0||||P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71059235|NCT01130532|141625231|SUPERIORITY_OR_OTHER||LS Mean Difference|24.5|STANDARD_ERROR_OF_MEAN|2.44|<|0.001||95.0||||P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71059236|NCT01130532|141625231|SUPERIORITY_OR_OTHER||LS Mean Difference|16.9|STANDARD_ERROR_OF_MEAN|2.37|<|0.001||95.0||||P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71059237|NCT01130532|141625231|SUPERIORITY_OR_OTHER||LS Mean Difference|17.2|STANDARD_ERROR_OF_MEAN|2.35|<|0.001||95.0||||P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71059238|NCT01130532|141625231|SUPERIORITY_OR_OTHER||LS Mean Difference|25.2|STANDARD_ERROR_OF_MEAN|2.57|<|0.001||95.0||||P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71059239|NCT01130532|141625231|SUPERIORITY_OR_OTHER||LS Mean Difference|25.1|STANDARD_ERROR_OF_MEAN|2.56|<|0.001||95.0||||P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71109362|NCT04016714|141724202|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.8|1.2|||Miettinen & Nurminen method|||Pertussis - PRN||1.2|-0.8|< 0.001
71109363|NCT04016714|141724202|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|-1.1|||<|0.001|TWO_SIDED|95.0|-3.3|0.9|||Miettinen & Nurminen method|||Hib-PRP||0.9|-3.3|< 0.001
71026462|NCT00782509|141560313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.653|STANDARD_ERROR_OF_MEAN|5.132|<|0.0001|TWO_SIDED|95.0|10.574|30.731|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||30.731|10.574|<0.0001
71026463|NCT00782509|141560314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.416|STANDARD_ERROR_OF_MEAN|0.127||0.0011|TWO_SIDED|95.0|-0.665|-0.167|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.167|-0.665|0.0011
71026464|NCT00782509|141560314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.513|STANDARD_ERROR_OF_MEAN|0.125|<|0.0001|TWO_SIDED|95.0|-0.76|-0.267|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.267|-0.760|<0.0001
71026465|NCT00782509|141560315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.157||0.0077|TWO_SIDED|95.0|-0.729|-0.111|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.111|-0.729|0.0077
71026466|NCT00782509|141560315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|0.155|<|0.0001||95.0|-1.065|-0.456|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.456|-1.065|<0.0001
71026467|NCT00782509|141560316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.837|STANDARD_ERROR_OF_MEAN|0.252||0.001|TWO_SIDED|95.0|-1.333|-0.342|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.342|-1.333|0.0010
71026468|NCT00782509|141560316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.278|STANDARD_ERROR_OF_MEAN|0.249|<|0.0001|TWO_SIDED|95.0|-1.767|-0.789|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.789|-1.767|<0.0001
71026469|NCT00782509|141560317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0122||95.0|-0.5|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.1|-0.5|0.0122
71026470|NCT00782509|141560317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0008||95.0|-0.6|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.1|-0.6|0.0008
71026471|NCT00782509|141560318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0028||95.0|-0.5|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.1|-0.5|0.0028
71026472|NCT00782509|141560318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0169||95.0|-0.5|0.0|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.0|-0.5|0.0169
71026473|NCT00782509|141560319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.018||95.0|-0.5|0.0|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.0|-0.5|0.0180
71026474|NCT00782509|141560319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0015||95.0|-0.6|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.1|-0.6|0.0015
71026475|NCT00782509|141560320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1313||95.0|-0.4|0.0|||Mixed Models Analysis|Model included treatment, tiotropium stratum,visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||0.0|-0.4|0.1313
71026476|NCT00782509|141560320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0089||95.0|-0.5|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.1|-0.5|0.0089
71026477|NCT00782509|141560321|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.993|STANDARD_ERROR_OF_MEAN|0.187||0.9853|TWO_SIDED|95.0|0.687|1.436|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.436|0.687|0.9853
71026478|NCT00782509|141560321|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.241|STANDARD_ERROR_OF_MEAN|0.222||0.2344|TWO_SIDED|95.0|0.873|1.763|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.763|0.873|0.2344
71026479|NCT00782509|141560322|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05|STANDARD_ERROR_OF_MEAN|0.438||0.9035|TWO_SIDED|95.0|0.463|2.38|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||2.380|0.463|0.9035
71026480|NCT00782509|141560322|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.958|STANDARD_ERROR_OF_MEAN|0.408||0.9304|TWO_SIDED|95.0|0.415|2.209|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||2.209|0.415|0.9304
71026481|NCT00782509|141560323|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09|STANDARD_ERROR_OF_MEAN|0.233||0.669|TWO_SIDED|95.0|0.717|1.657|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.657|0.717|0.6690
71026482|NCT00782509|141560323|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.344|STANDARD_ERROR_OF_MEAN|0.273||0.1437|TWO_SIDED|95.0|0.902|2.002|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||2.002|0.902|0.1437
71059240|NCT01130532|141625231|SUPERIORITY_OR_OTHER||LS Mean Difference|15.1|STANDARD_ERROR_OF_MEAN|2.88|<|0.001||95.0||||P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71059241|NCT01130532|141625231|SUPERIORITY_OR_OTHER||LS Mean Difference|17.3|STANDARD_ERROR_OF_MEAN|2.86|<|0.001||95.0||||P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71059242|NCT01130532|141625232|SUPERIORITY_OR_OTHER||LS Mean Difference|25.1|STANDARD_ERROR_OF_MEAN|2.76|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANOVA|||||||<0.001
71109364|NCT04016714|141724202|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|-0.6|||<|0.001|TWO_SIDED|95.0|-2.0|0.5|||Miettinen & Nurminen method|||HBsAg||0.5|-2.0|< 0.001
71109365|NCT04016714|141724202|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.9|0.9|||Miettinen & Nurminen method|||Poliovirus 1||0.9|-0.9|< 0.001
71109366|NCT04016714|141724202|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.6|1.1|||Miettinen & Nurminen method|||Poliovirus 2||1.1|-0.6|< 0.001
71109367|NCT04016714|141724202|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.8|0.7|||Miettinen & Nurminen method|||Poliovirus 3||0.7|-0.8|< 0.001
71109368|NCT04016714|141724204|OTHER||GMC ratio|0.82|||||TWO_SIDED|95.0|0.75|0.89||||||Serotype 1||0.89|0.75|
71109369|NCT04016714|141724204|OTHER||GMC ratio|1.81|||||TWO_SIDED|95.0|1.66|1.98||||||Serotype 3||1.98|1.66|
71109370|NCT04016714|141724204|OTHER||GMC ratio|1.09|||||TWO_SIDED|95.0|0.99|1.21||||||Serotype 4||1.21|0.99|
71109371|NCT04016714|141724204|OTHER||GMC ratio|0.91|||||TWO_SIDED|95.0|0.81|1.01||||||Serotype 5||1.01|0.81|
70852212|NCT03615040|141192863|SUPERIORITY||Mean Difference (Net)|0.04||||0.094|TWO_SIDED|95.0|-0.01|0.09|||Mixed Models Analysis|||mixed effect linear model with explanatory variables of treatment arm, number of exacerbations in the 12 months prior to the trial (stratification factor), visit time point (as categorical variable), baseline score and patient identification as a random effect to account for repeated measures over time was fitted for each outcome. Adjusted mean difference between treatment arms with 95% confidence interval and p-value were reported. In the modified ITT population.||0.09|-0.01|0.094
70935618|NCT00923078|141372083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|1.27||0.63|TWO_SIDED|95.0|-3.14|1.93|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.93|-3.14|0.63
70935619|NCT00923078|141372083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.92|STANDARD_ERROR_OF_MEAN|1.27||0.47|TWO_SIDED|95.0|-3.45|1.61|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.61|-3.45|0.47
71026483|NCT00782509|141560324|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.188|STANDARD_ERROR_OF_MEAN|0.2251||0.3637|TWO_SIDED|95.0|0.8188|1.7234|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.7234|0.8188|0.3637
71109372|NCT04016714|141724204|OTHER||GMC ratio|0.44|||||TWO_SIDED|95.0|0.38|0.5||||||Serotype 6A||0.50|0.38|
71109373|NCT04016714|141724204|OTHER||GMC ratio|1.73|||||TWO_SIDED|95.0|1.46|2.05||||||Serotype 6B||2.05|1.46|
71109374|NCT04016714|141724204|OTHER||GMC ratio|0.78|||||TWO_SIDED|95.0|0.71|0.84||||||Serotype 7F||0.84|0.71|
71109375|NCT04016714|141724204|OTHER||GMC ratio|1.0|||||TWO_SIDED|95.0|0.9|1.12||||||Serotype 9V||1.12|0.90|
71109376|NCT04016714|141724204|OTHER||GMC ratio|1.02|||||TWO_SIDED|95.0|0.89|1.18||||||Serotype 14||1.18|0.89|
71109377|NCT04016714|141724204|OTHER||GMC ratio|0.75|||||TWO_SIDED|95.0|0.68|0.82||||||Serotype 18C||0.82|0.68|
71109378|NCT04016714|141724204|OTHER||GMC ratio|0.72|||||TWO_SIDED|95.0|0.64|0.81||||||Serotype 19A||0.81|0.64|
71109379|NCT04016714|141724204|OTHER||GMC ratio|0.69|||||TWO_SIDED|95.0|0.62|0.77||||||Serotype 19F||0.77|0.62|
71109380|NCT04016714|141724204|OTHER||GMC ratio|1.32|||||TWO_SIDED|95.0|1.16|1.51||||||Serotype 23F||1.51|1.16|
71109381|NCT04016714|141724204|SUPERIORITY||GMC ratio|81.01|||||TWO_SIDED|95.0|73.12|89.75||||||Serotype 22F||89.75|73.12|
71109382|NCT04016714|141724204|OTHER||GMC ratio|7.81|||||TWO_SIDED|95.0|6.82|8.94||||||Serotype 33F||8.94|6.82|
71109383|NCT02358993|141724207|NON_INFERIORITY|Non-inferiority of the primary outcome was achieved if the lower limit of the 95% confidence interval of the mean difference was greater than the specified non-inferiority margin of 15%(a clinically relevant margin within the range of those commonly used in non-inferiority and equivalence trials for studies examining antibiotic use for UTI)|Risk Ratio (RR)|-0.01|||||TWO_SIDED|95.0||||||||||||
71109384|NCT01822665|141724225|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.11|||<|0.0001|TWO_SIDED|95.0|-1.63|-0.59||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.||-0.59|-1.63|<0.0001
71109385|NCT01822665|141724226|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.0095|TWO_SIDED|95.0|-1.23|-0.18|||t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.||-0.18|-1.23|0.0095
71026484|NCT00782509|141560324|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.2822|STANDARD_ERROR_OF_MEAN|0.2403||0.1853|TWO_SIDED|95.0|0.8874|1.8527|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.8527|0.8874|0.1853
71026485|NCT00782509|141560325|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.0314|STANDARD_ERROR_OF_MEAN|0.4664||0.9455|TWO_SIDED|95.0|0.4244|2.5063|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||2.5063|0.4244|0.9455
71026486|NCT00782509|141560325|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.1273|STANDARD_ERROR_OF_MEAN|0.5028||0.7883|TWO_SIDED|95.0|0.4696|2.7064|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||2.7064|0.4696|0.7883
71026487|NCT00782509|141560326|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.2846|STANDARD_ERROR_OF_MEAN|0.2803||0.2514|TWO_SIDED|95.0|0.837|1.9717|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.9717|0.8370|0.2514
71026488|NCT00782509|141560326|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.3373|STANDARD_ERROR_OF_MEAN|0.2901||0.1807|TWO_SIDED|95.0|0.8735|2.0474|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||2.0474|0.8735|0.1807
71026489|NCT04875065|141560329|SUPERIORITY||Mean Difference (Net)|-1.875|STANDARD_ERROR_OF_MEAN|4.804899|||TWO_SIDED|95.0|-13.23678|9.48678|||||Higher scale scores indicate greater loneliness. Thus, Mean change in total score is calculated as change = baseline intervention scores - post score, so that positive change values indicate symptom improvement.|||9.486780|-13.236780|
71026490|NCT04875065|141560330|SUPERIORITY||Median Difference (Final Values)|0.542857|STANDARD_ERROR_OF_MEAN|2.389651|||TWO_SIDED|95.0|-5.107769|6.193483|||||Higher scale scores indicate better social functioning. Thus, Mean change in total score is calculated as change = post intervention scores - baseline score, so that positive change values indicate symptom improvement.|||6.193483|-5.107769|
71026491|NCT04875065|141560331|SUPERIORITY||Mean Difference (Net)|0.5625|STANDARD_ERROR_OF_MEAN|5.176732|||TWO_SIDED|95.0|-11.678525|12.803525|||||Higher scale scores indicate better social relationship quality of life. Thus, Mean change in total score is calculated as change = post intervention scores - baseline score, so that positive change values indicate symptom improvement.|||12.803525|-11.678525|
71059243|NCT01130532|141625232|SUPERIORITY_OR_OTHER||LS Mean Difference|28.2|STANDARD_ERROR_OF_MEAN|2.74|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANOVA|||||||<0.001
71059244|NCT01130532|141625234|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test|||||||<0.001
71059245|NCT01130532|141625234|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test|||||||<0.001
71059246|NCT01130532|141625234|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test|||||||<0.001
71059247|NCT01130532|141625235|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test|||||||0.002
71059248|NCT01130532|141625235|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test|||||||0.004
71059249|NCT01130532|141625235|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test|||||||<0.001
71059250|NCT04909853|141625257|OTHER||Ratio of Adjusted Geometric Means|129.78|||||TWO_SIDED|90.0|101.93|165.25|||||Analysis used one-way ANOVA model with renal function as a fixed effect. The ratio of adjusted geometric means (test \[impaired\]/reference \[normal\]) and 90% confidence interval (CI) were expressed as percentages.|||165.25|101.93|
71059251|NCT04909853|141625257|OTHER||Ratio of Adjusted Geometric Means|138.12|||||TWO_SIDED|90.0|113.18|168.55|||||Analysis used one-way ANOVA model with renal function as a fixed effect. The ratio of adjusted geometric means (test \[impaired\]/reference \[normal\]) and 90% confidence interval (CI) were expressed as percentages.|||168.55|113.18|
71059252|NCT04909853|141625257|OTHER||Ratio of Adjusted Geometric Means|148.02|||||TWO_SIDED|90.0|111.4|196.68|||||Analysis used one-way ANOVA model with renal function as a fixed effect. The ratio of adjusted geometric means (test \[impaired\]/reference \[normal\]) and 90% confidence interval (CI) were expressed as percentages.|||196.68|111.40|
71059253|NCT04909853|141625258|OTHER||Ratio of Adjusted Geometric Means|123.84|||||TWO_SIDED|90.0|99.64|153.91|||||Analysis used one-way ANOVA model with renal function as a fixed effect. The ratio of adjusted geometric means (test \[impaired\]/reference \[normal\]) and 90% confidence interval (CI) were expressed as percentages.|||153.91|99.64|
71059254|NCT04909853|141625258|OTHER||Ratio of Adjusted Geometric Means|187.4|||||TWO_SIDED|90.0|148.52|236.46|||||Analysis used one-way ANOVA model with renal function as a fixed effect. The ratio of adjusted geometric means (test \[impaired\]/reference \[normal\]) and 90% confidence interval (CI) were expressed as percentages.|||236.46|148.52|
71059255|NCT04909853|141625258|OTHER||Ratio of Adjusted Geometric Means|304.49|||||TWO_SIDED|90.0|237.6|390.21|||||Analysis used one-way ANOVA model with renal function as a fixed effect. The ratio of adjusted geometric means (test \[impaired\]/reference \[normal\]) and 90% confidence interval (CI) were expressed as percentages.|||390.21|237.60|
71059256|NCT01295112|141625308|SUPERIORITY|||||||2e-05|||||||Cochran-Mantel-Haenszel|||||||0.00002
71059257|NCT01295112|141625309|NON_INFERIORITY|Non-inferiority will be described by the 95% upper bound of the confidence interval on the difference in the improvement from baseline in BCVA|Mean Difference (Final Values)|2.51|STANDARD_DEVIATION|17.96||0.53|TWO_SIDED|90.0|-4.43|9.74||The p-value is assume superiority. The 95% upper confidence (upper end of the 90% Confidence interval) interval for the non-inferiority analysis is provided below.|t-test, 1 sided|||||9.74|-4.43|0.53
70935620|NCT00923078|141372083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|1.27||0.8|TWO_SIDED|95.0|-2.85|2.22|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||2.22|-2.85|0.80
70941719|NCT04748445|141383935|OTHER||Slope|-0.001649|STANDARD_ERROR_OF_MEAN|7.998||0.0413|TWO_SIDED|90.0|-0.002974|-0.0003238|||Mixed Models Analysis|||EE\_MFCC 1st order delta 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0003238|-0.002974|0.0413
71026492|NCT00395226|141560336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57||||0.284|TWO_SIDED|95.0|-0.47|1.62||The a priori significance threshold level was 0.05 (two-sided)|ANCOVA|The ANCOVA used group as a factor and baseline rosacea severity score as a covariate.|The effect of zinc sulfate treatment on rosacea severity score was estimated with baseline rosacea severity score included in the regression model|"The null hypothesis was no group differences. The alternative hypothesis was that the zinc sulfate arm is superior to placebo arm."||1.62|-0.47|0.2840
71109386|NCT01822665|141724226|SUPERIORITY_OR_OTHER||LS mean difference|0.19||||0.4794|TWO_SIDED|95.0|-0.34|0.72||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.||0.72|-0.34|0.4794
71109387|NCT01822665|141724226|SUPERIORITY_OR_OTHER||LS mean difference|0.4||||0.1429|TWO_SIDED|95.0|-0.14|0.95||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.||0.95|-0.14|0.1429
71109388|NCT01822665|141724226|SUPERIORITY_OR_OTHER||LS mean difference|1.3|||<|0.0001|TWO_SIDED|95.0|0.75|1.84||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.||1.84|0.75|<0.0001
71109389|NCT01822665|141724226|SUPERIORITY_OR_OTHER||LS mean difference|0.89||||0.002|TWO_SIDED|95.0|0.34|1.45||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.||1.45|0.34|0.0020
71109390|NCT01822665|141724227|SUPERIORITY_OR_OTHER||LS mean difference|-0.09||||0.6497|TWO_SIDED|95.0|-0.49|0.31||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments.||0.31|-0.49|0.6497
71109391|NCT01822665|141724227|SUPERIORITY_OR_OTHER||LS mean difference|-0.06||||0.7591|TWO_SIDED|95.0|-0.46|0.34||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments||0.34|-0.46|0.7591
71026493|NCT00282256|141560350|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for AUC0-24 was found to lie entirely within the 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|100.9|||||TWO_SIDED|90.0|90.8|112.1|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance was used for the comparisons of AUC0-24. Exposure at steady state was used for tacrolimus (defined as Day 7) and for tacrolimus MR (defined as Day 14). The natural log (ln) was used to transform AUC0-24 prior to analysis and the results were transformed back to the original scale for the presentation of results.||112.1|90.8|
71026494|NCT00282256|141560352|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for Cmin was found to lie entirely within the 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|91.8|||||TWO_SIDED|90.0|82.6|102.2|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance was used for the comparisons of Cmin. Exposure at steady state was used for tacrolimus (defined as Day 7) and for tacrolimus MR (defined as Day 14). The natural log (ln) was used to transform Cmin prior to analysis and the results were transformed back to the original scale for the presentation of results.||102.2|82.6|
71026495|NCT01569451|141560372|SUPERIORITY_OR_OTHER|||||||0.0493|||||||Chi-squared|||||||0.0493
71026496|NCT01569451|141560373|SUPERIORITY_OR_OTHER|||||||0.0268|||||||Peto|||||||0.0268
71026497|NCT01569451|141560374|SUPERIORITY_OR_OTHER|||||||0.0189|||||||Chi-squared|||||||0.0189
71026498|NCT01569451|141560375|SUPERIORITY_OR_OTHER|||||||0.3167|||||||Chi-squared|||||||0.3167
71026499|NCT01569451|141560376|SUPERIORITY_OR_OTHER|||||||0.094|||||||Chi-squared|||||||0.0940
71026500|NCT01569451|141560377|SUPERIORITY_OR_OTHER|||||||0.3507|||||||Fisher Exact|||||||0.3507
71026501|NCT01569451|141560378|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71026502|NCT01569451|141560379|SUPERIORITY_OR_OTHER|||||||0.4904|||||||t-test, 2 sided|||T-test||||0.4904
71026503|NCT01569451|141560380|SUPERIORITY_OR_OTHER|||||||0.4073|||||||Chi-squared|||||||0.4073
71026504|NCT01569451|141560381|SUPERIORITY_OR_OTHER|||||||0.8677|||||||Mixed Models Analysis|||||||0.8677
71026505|NCT01569451|141560382|OTHER|Mean difference between treatment groups.||||||0.3974|||||||t-test, 2 sided|||||||0.3974
70941720|NCT04748445|141383935|OTHER||Slope|0.0008236|STANDARD_ERROR_OF_MEAN|7.053||0.2451|TWO_SIDED|90.0|-0.0003452|0.001992|||Mixed Models Analysis|||EE\_MFCC 1st order delta 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001992|-0.0003452|0.2451
71059258|NCT01811472|141625323|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was largely driven by the maximum true response assumed in the candidate response shapes, which is a difference of -5.2% for pradigastat vs placebo for the primary endpoint.|Mean Difference (Net)|-1.69||||0.3128|TWO_SIDED|90.0|-4.46|1.09|||Mixed Model of Repeated Measurements|Degrees of freedom are adjusted using the Kenward-Roger method.||Hypothesis was tested at the 1-sided 5% significance level to assess if LCQ908 5mg/10mg was different from placebo.||1.09|-4.46|0.3128
71059259|NCT01811472|141625323|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was largely driven by the maximum true response assumed in the candidate response shapes, which is a difference of -5.2% for pradigastat vs placebo for the primary endpoint.|Mean Difference (Net)|-2.89||||0.0457|TWO_SIDED|90.0|-5.25|-0.53|||Mixed Model of Repeated Measurements|Degrees of freedom are adjusted using the Kenward-Roger method.||Hypothesis was tested at the 1-sided 5% significance level to assess if LCQ908 10mg/20mg was different from placebo.||-0.53|-5.25|0.0457
71059260|NCT01995513|141625346|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.828||||0.2176|TWO_SIDED|95.0|0.612|1.119||P-value was based on log-rank test stratified by PSA response (greater than or equal to \[\>=\] 0 percent \[%\] to less than \[\<\] 30% vs \>=30%) at Week 13 in the open-label period.|Log Rank||Hazard ratio was based on a Cox regression model (with treatment as the only covariate) stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period and is relative to Enzalutamide-placebo with \< 1 favoring Enzalutamide.|||1.119|0.612|0.2176
71059261|NCT01995513|141625347|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.874||||0.45|TWO_SIDED|95.0|0.617|1.239||P-value was based on log-rank test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Log Rank||Hazard ratio was based on a Cox regression model (with treatment as the only covariate) stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period and is relative to Enzalutamide-placebo with \< 1 favoring Enzalutamide.|||1.239|0.617|0.4500
71059262|NCT01995513|141625348|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|-1.65||||0.3101|TWO_SIDED|95.0|-4.82|1.51||P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Cochran-Mantel-Haenszel||Difference in response rate was based upon standard normal approximation.|This analysis is reported for participants with \>=50% decrease from baseline in PSA response.||1.51|-4.82|0.3101
71059263|NCT01995513|141625348|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|-0.04||||0.9917|TWO_SIDED|95.0|-3.9|3.82||P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Cochran-Mantel-Haenszel||Difference in response rate was based upon standard normal approximation.|This analysis is reported for participants with \>=30% decrease from baseline in PSA response.||3.82|-3.90|0.9917
71059264|NCT01995513|141625349|SUPERIORITY_OR_OTHER_LEGACY||Difference in Objective Response Rate|-5.0||||0.1653|TWO_SIDED|95.0|-11.75|1.75||P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Cochran-Mantel-Haenszel||Difference in objective response rate was based upon standard normal approximation.|This analysis is reported for participants with CR+PR.||1.75|-11.75|0.1653
71059265|NCT01995513|141625349|SUPERIORITY_OR_OTHER_LEGACY||Difference in Objective Response Rate|10.92||||0.3216|TWO_SIDED|95.0|-10.37|32.21||P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Cochran-Mantel-Haenszel||Difference in objective response rate was based upon standard normal approximation.|This analysis is reported for participants with CR+PR+SD.||32.21|-10.37|0.3216
71059266|NCT01995513|141625350|SUPERIORITY_OR_OTHER_LEGACY||Difference in Progression Rate|9.09||||0.2963|TWO_SIDED|95.0|-7.69|25.87||P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Cochran-Mantel-Haenszel||Difference in Progression Rate was based upon normal approximation.|||25.87|-7.69|0.2963
71059267|NCT01995513|141625351|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.861||||0.3818|TWO_SIDED|95.0|0.616|1.204||P-value was based on log-rank test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Log Rank||Hazard ratio was based on a Cox regression model (with treatment as the only covariate) stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period and is relative to Enzalutamide-placebo with \< 1 favoring Enzalutamide.|||1.204|0.616|0.3818
71059268|NCT01995513|141625358|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.399||||0.0739|TWO_SIDED|95.0|0.967|2.025||P-value was based on log-rank test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period|Log Rank||Hazard ratio was based on a Cox regression model (with treatment as the only covariate) stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period and is relative to Enzalutamide-placebo with \< 1 favoring Enzalutamide.|||2.025|0.967|0.0739
71059269|NCT03105518|141625363|SUPERIORITY||1 way test, chisquare approximation|7.188||||0.007|TWO_SIDED||||||Kruskal-Wallis|||VAS at Time 0; Follicles ≤10 vs. \> 10||||0.007
71059270|NCT03105518|141625363|SUPERIORITY||1 way Test, ChiSquare Approximation|3.6396||||0.056|TWO_SIDED||||||Kruskal-Wallis|||VAS at Time 15; Follicles ≤10 vs. \> 10||||0.056
71059271|NCT03105518|141625363|SUPERIORITY||1 way Test, ChiSquare Approximation|15.971|||<|0.0001|TWO_SIDED||||||Kruskal-Wallis|||VAS at Time 30; Follicles ≤10 vs. \> 10||||<0.0001
71059272|NCT03105518|141625363|SUPERIORITY||1-way Test, ChiSquare Approximation|16.0972|||<|0.0001|TWO_SIDED||||||Kruskal-Wallis|||VAS at Time 60; Follicles ≤10 vs. \> 10||||<0.0001
71059273|NCT03105518|141625364|SUPERIORITY||1-way Test, ChiSquare Approximation|2.7205||||0.0991|TWO_SIDED||||||Kruskal-Wallis|||VAS at Post Operative Day 1; Follicles ≤10 vs. \> 10||||0.0991
71059274|NCT03105518|141625364|SUPERIORITY||1 way Test, ChiSquare Approximation|1.5654||||0.2109|TWO_SIDED||||||Kruskal-Wallis|||VAS at Post Operative Day 2; Follicles ≤10 vs. \> 10||||0.2109
71059275|NCT03105518|141625364|SUPERIORITY||1-way Test, ChiSquare Approximation|0.008||||0.9287|TWO_SIDED||||||Kruskal-Wallis|||VAS at Post Operative Day 3; Follicles ≤10 vs. \> 10||||0.9287
71059276|NCT05387889|141625365|SUPERIORITY||Mean Difference (Final Values)|0.05|||<|0.054|TWO_SIDED|95.0||||The threshold for the level of significance is set at less than or equal to 0.05|ANCOVA|||||||< 0.054
71026506|NCT00936975|141560409|SUPERIORITY_OR_OTHER||Slope|-6.6084|STANDARD_ERROR_OF_MEAN|1.7644|<|0.001|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|GEE||GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|This was an exploratory study and no a priori assumptions were employed.||||<0.001
71026507|NCT00936975|141560410|SUPERIORITY_OR_OTHER||Slope|-0.0115|STANDARD_ERROR_OF_MEAN|0.0089||0.1945|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|GEE|GEE was used to model the change, accounting for 37 tumors in 12 patients measured at 2 time points.|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|the difference in Patlak flux in tumor bone between baseline and 12 weeks, accounting for the fact that each participant could contribute more than one tumor bone.||||0.1945
71026508|NCT00936975|141560411|SUPERIORITY_OR_OTHER||Slope|0.33|STANDARD_ERROR_OF_MEAN|0.3274||0.32|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized Estimating Equation|GEE was used to model the change, accounting for 37 tumors in 12 patients measured at 2 time points.|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|||||0.32
71026509|NCT00936975|141560411|SUPERIORITY_OR_OTHER||Slope|6.98|STANDARD_ERROR_OF_MEAN|1.6943|<|0.001|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized Estimating Equations|Age was included in the model as a confounder|Estimated value is the slope of the Normal bone. Tumor Bone was used as reference category. GEEs, rather than a simple mean difference, were used to account for clustering and correlation of bone measurement values within a patient|H0: No difference in uptake b/w normal \& tumor bones||||<0.001
71026510|NCT00936975|141560412|SUPERIORITY_OR_OTHER||Slope|-0.0177|STANDARD_ERROR_OF_MEAN|0.0125||0.16|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized Estimating Equations|GEE was used to model the change, accounting for 37 tumors in 12 patients measured at 2 time points.|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|||||0.16
71026511|NCT00936975|141560413|SUPERIORITY_OR_OTHER||Slope|0.0017|STANDARD_ERROR_OF_MEAN|0.0027||0.53|TWO_SIDED||||||Generalized Estimating Equation|GEE was used to model the change, accounting for 37 tumors in 12 patients measured at 2 time points.|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|||||0.53
71026512|NCT00936975|141560413|SUPERIORITY_OR_OTHER||Slope|0.0205|STANDARD_ERROR_OF_MEAN|0.0128||0.1095|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized estimating equations|Age was included in the model as a confounder|Estimated value is the slope of the Normal bone. Tumor Bone was used as reference category. GEEs, rather than a simple mean difference, were used to account for clustering and correlation of bone measurement values within a patient|H0: influx(Ki) is the same in normal and tumor bones||||0.1095
71059277|NCT05387889|141625366|SUPERIORITY||Mean Difference (Final Values)|0.05|||<|0.25|TWO_SIDED|95.0||||The threshold for the level of significance is set at less than or equal to 0.05|ANCOVA|||||||< 0.25
71059278|NCT05387889|141625367|SUPERIORITY||Mean Difference (Final Values)|0.05|||<|0.07|TWO_SIDED|95.0||||The threshold for the level of significance is set at less than or equal to 0.05|ANCOVA|||||||< 0.07
71059279|NCT02045446|141625370|SUPERIORITY||Hazard Ratio (HR)|0.304||||0.01|TWO_SIDED|95.0|0.113|0.815|||Log Rank|||||0.815|0.113|.01
71059280|NCT01895777|141625399|NON_INFERIORITY|Non-inferiority margin of 20%|Difference in Rates|-0.038|||=|0.0001|TWO_SIDED|90.0|-0.141|0.066||p-value for non-inferiority is actually \<0.0001|Cochran-Mantel-Haenszel||Difference in rates (SOC - DE)|The primary analysis of the primary efficacy endpoint used the randomised set, following the intention-to-treat principle, based on adjudication-confirmed data. Age group was used as stratification factor using a Mantel-Haenszel type weighted average of differences.||0.066|-0.141|= 0.0001
71059281|NCT01895777|141625400|OTHER||Kaplan-Meier estimate|0.0|||||TWO_SIDED|90.0|-0.032|0.032|||Kaplan-Meier estimate||Kaplan-Meier estimate of rate difference.|Time-to event endpoint using Kaplan-Meier estimates based on adjudication-confirmed data. Due to the low event rate of major bleeding, age group stratification was not considered.||0.032|-0.032|
71059282|NCT01895777|141625406|OTHER||Hazard Ratio (HR)|1.145|||||TWO_SIDED|90.0|0.736|1.78||||||Any bleeding events was analysed as time-to-event endpoint using a stratified Cox proportional hazard model with treatment as a covariate in the model and age group as the stratification factor. A pooling of age groups was performed as no events were observed in certain age group.||1.780|0.736|
71059283|NCT01895777|141625407|OTHER||Hazard Ratio (HR)|69990000.0||||0.9976|TWO_SIDED|90.0|0.0|999999999.0|||Cox proportional hazard model||Upper Limit of the 90% confidence interval was not assessable|All-cause mortality was analyzed as time-to-event endpoint using a stratified Cox proportional hazard model with treatment as a covariate in the model.||999999999|0.000|0.9976
71059284|NCT02064296|141625412|SUPERIORITY|||||||0.333|||||||t-test, 2 sided|||Salience co-activation pattern at rest vs. with pressure pain.||||0.3330
71059285|NCT02064296|141625412|SUPERIORITY|||||||0.6474|||||||t-test, 2 sided|||This statistical analysis covers the sensorimotor co-activation pattern at rest vs. with pressure pain for Healthy controls||||0.6474
71059286|NCT02064296|141625412|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Salience co-activation pattern at rest vs. with pressure pain||||<0.0001
70935621|NCT00923078|141372084|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|0.98||0.26|TWO_SIDED|95.0|-3.06|0.85|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||0.85|-3.06|0.26
70935622|NCT00923078|141372084|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.47|STANDARD_ERROR_OF_MEAN|0.97||0.13|TWO_SIDED|95.0|-3.41|0.46|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||0.46|-3.41|0.13
70941721|NCT04748445|141383935|OTHER||Slope|-0.000292|STANDARD_ERROR_OF_MEAN|6.839||0.6702|TWO_SIDED|90.0|-0.001425|0.0008413|||Mixed Models Analysis|||EE\_MFCC 1st order delta 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0008413|-0.001425|0.6702
71059287|NCT02064296|141625412|SUPERIORITY|||||||0.0004|||||||t-test, 2 sided|||This statistical analysis covers the sensorimotor co-activation pattern at rest vs. with pressure pain for Fibromyalgia patients||||0.0004
71059288|NCT02064296|141625413|SUPERIORITY|||||||0.0653|||||||t-test, 2 sided|||This is a comparison of Mock Laser Acupuncture pre-and post 4 weeks of treatment.||||0.0653
71059289|NCT02064296|141625413|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||This is a P value for the change in Traditional Acupuncture, pre and post 4 weeks of treatment.||||<0.0001
71059290|NCT02064296|141625414|SUPERIORITY|||||||0.7399|||||||t-test, 2 sided|||Glx statistical comparison||||0.7399
71059291|NCT02064296|141625414|SUPERIORITY|||||||0.6226|||||||t-test, 2 sided|||Glx statistical comparison||||0.6226
71059292|NCT02064296|141625415|SUPERIORITY|||||||0.6344|||||||t-test, 2 sided|||GABA statistical comparison||||0.6344
71059293|NCT02064296|141625415|SUPERIORITY|||||||0.7985|||||||t-test, 2 sided|||GABA statistical comparison||||0.7985
71059294|NCT03885661|141625445|SUPERIORITY|||||||0.65|||||||mixed effects regression|testing for the outcome employed mixed effects regression. The key fixed effects were group assignment, period, and the group X period interaction.||||||0.65
71059295|NCT03172494|141625452|NON_INFERIORITY|Non-inferiority of insulin degludec/liraglutide versus insulin degludec was considered as confirmed if the 95% confidence interval (CI) for the mean treatment difference lied entirely below 0.4%. Non-inferiority was investigated on the FAS.|Mean treatment difference|-0.59|||<|0.0001|TWO_SIDED|95.0|-0.73|-0.46|||ANCOVA|||The change from baseline in HbA1c after 26 weeks of treatment was analysed using an analysis of covariance (ANCOVA) model with treatment and previous oral anti-diabetic (OAD) treatment as fixed factors and baseline HbA1c as covariate. Missing values were imputed by last observation carried forward (LOCF).||-0.46|-0.73|<0.0001
71059296|NCT03172494|141625452|SUPERIORITY||Mean treatment difference|-0.63|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.49|||ANCOVA|||The change from baseline in HbA1c after 26 weeks of treatment was analysed using an ANCOVA model with treatment and previous OAD treatment as fixed factors and baseline HbA1c as covariate. Missing values were imputed by LOCF.||-0.49|-0.76|<0.0001
70941722|NCT04748445|141383935|OTHER||Slope|-0.0003363|STANDARD_ERROR_OF_MEAN|6.312||0.5951|TWO_SIDED|90.0|-0.001382|0.0007097|||Mixed Models Analysis|||EE\_MFCC 1st order delta 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0007097|-0.001382|0.5951
71059297|NCT03086551|141625514|OTHER||Effect Size - Cohen's d|0.2|||||TWO_SIDED||||||||Cohen's d was calculated as time to complete the sequence at the pre-baseline assessment minus the time it took to complete the sequence at the post-intervention assessment. The denominator reflected pooled variance.|Magnitude of change in sequence completion time from pre-baseline to post-intervention for the Active arm. Cohen's d was calculated as a measure of effect size.||||
71059298|NCT03086551|141625514|OTHER||Effect Size - Cohen's d|0.69|||||TWO_SIDED||||||||Cohen's d was calculated as time to complete the sequence at the pre-baseline assessment minus the time it took to complete the sequence at the post-intervention assessment. The denominator reflected pooled variance.|Magnitude of change in sequence completion time from pre-baseline to post-intervention for the Sham arm. Cohen's d was calculated as a measure of effect size.||||
71059299|NCT03086551|141625514|OTHER|Cohen's d effect size was calculated to compare the magnitude of change in time to complete the movement sequence from pre-baseline to post-intervention across the Active and Sham arms.|Effect Size - Cohen's d|-0.8|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to post-intervention for the Active arm minus change from pre- to post-intervention for the Sham arm. The denominator reflected pooled variance.|||||
71059300|NCT03086551|141625515|OTHER||Effect Size - Cohen's d|-0.08|||||TWO_SIDED||||||||Cohen's d was calculated as aggregate time to complete all elements at the pre-baseline assessment minus the aggregate time it took to complete all elements at the post-intervention assessment. The denominator reflected pooled variance.|The magnitude of transfer of the task specific practice to functional activities of daily live for the stroke affected limb was assessed by calculating the magnitude of change (Cohen's d) in time to complete the activities of the Jebsen-Taylor Hand Function Test from pre-baseline to post-intervention in the Active arm.||||
71059301|NCT03086551|141625515|OTHER||Effect Size - Cohen's d|0.5|||||TWO_SIDED||||||||Cohen's d was calculated as aggregate time to complete all elements at the pre-baseline assessment minus the aggregate time it took to complete all elements at the post-intervention assessment. The denominator reflected pooled variance.|The magnitude of transfer of the task specific practice to functional activities of daily live for the stroke affected limb was assessed by calculating the magnitude of change (Cohen's d) in time to complete the activities of the Jebsen-Taylor Hand Function Test from pre-baseline to post-intervention in the Sham arm.||||
71059302|NCT03086551|141625515|OTHER||Effect Size - Cohen's d|-1.84|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to post-intervention for the Active arm minus the change from pre- to post-intervention for the Sham arm. The denominator reflected pooled variance.|Comparison across study arm of the magnitude of improvement in aggregate time to complete all elements of the Jebsen-Taylor Hand Function Test for the stroke affected limb. Cohen's d was calculated as a measure of effect size.||||
70935623|NCT00923078|141372084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.98||0.71|TWO_SIDED|95.0|-2.32|1.58|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.58|-2.32|0.71
70935624|NCT02449902|141372112|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
70935625|NCT02449902|141372113|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||ANOVA|||||||0.0002
70935626|NCT02449902|141372114|SUPERIORITY_OR_OTHER|||||||0.0017|TWO_SIDED||||||ANCOVA|||||||0.0017
70935627|NCT02449902|141372115|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||ANCOVA|||||||0.0002
71109392|NCT01822665|141724227|SUPERIORITY_OR_OTHER||LS mean difference|0.17||||0.4126|TWO_SIDED|95.0|-0.24|0.57||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments.||0.57|-0.24|0.4126
70935628|NCT02449902|141372116|SUPERIORITY_OR_OTHER|||||||0.9951|TWO_SIDED||||||ANOVA|||||||0.9951
70935629|NCT02449902|141372117|SUPERIORITY_OR_OTHER|||||||0.1429|TWO_SIDED||||||Fisher Exact|||||||0.1429
70935630|NCT02449902|141372118|SUPERIORITY_OR_OTHER|||||||0.1945|TWO_SIDED||||||ANCOVA|||||||0.1945
71026513|NCT00936975|141560414|SUPERIORITY_OR_OTHER||Slope|0.0061|STANDARD_ERROR_OF_MEAN|0.0021||0.0033|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized Estimating Equations|GEE was used to model the change, accounting for 37 bones in 12 patients measured at 2 time points.|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|||||0.0033
71026514|NCT00936975|141560414|SUPERIORITY_OR_OTHER||Slope|0.0177|STANDARD_ERROR_OF_MEAN|0.0097||0.067|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized estimating equations|Age was included in the model as a confounder|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|H0: Change Patlak Flux from TP1 to TP2 is the same in normal and tumor bones||||0.0670
71026515|NCT00936975|141560414|SUPERIORITY_OR_OTHER||Slope|32.3288|STANDARD_ERROR_OF_MEAN|14.6956||0.0278|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized estimating equations||Estimated value is the slope of the Normal bone. Tumor Bone was used as reference category. GEEs, rather than a simple mean difference, were used to account for clustering and correlation of bone measurement values within a patient|H0: %Change in Patlak Flux between timepoint 1 and 2 is the same for Normal and Tumor bones||||0.0278
71026516|NCT02041702|141560418|SUPERIORITY|The 2-sided 90% confidence interval (CI) was calculated using the Clopper-Pearson method.|Ratio|100.0|||<|0.01|TWO_SIDED|90.0|97.6|100.0|||Clopper-Pearson|Clopper-Pearson CI for the binomial proportion|The null hypothesis would be rejected if the lower bound of the 2-sided 90% confidence interval was greater than 90%.|The hypothesis was: H0: P≤ 90% vs H1: P\>90% P: The proportion of subjects free from MRI scan related complications at 1 month post MRI scan in cardiac MRI scan group||100|97.6|<0.01
71109393|NCT01822665|141724227|SUPERIORITY_OR_OTHER||LS mean difference|0.03||||0.8903|TWO_SIDED|95.0|-0.39|0.45||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments||0.45|-0.39|0.8903
70935631|NCT02449902|141372119|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANCOVA|||||||0.0001
70935632|NCT02449902|141372120|SUPERIORITY_OR_OTHER|||||||0.182|TWO_SIDED||||||ANCOVA|||||||0.1820
70935633|NCT02449902|141372121|SUPERIORITY_OR_OTHER|||||||0.0401|TWO_SIDED||||||ANCOVA|||||||0.0401
70935634|NCT02362789|141372122|SUPERIORITY||Mean Difference (Net)|-18.3||||0.0055|TWO_SIDED|95.0|-31.01|-5.59|||ANCOVA|||||-5.59|-31.01|0.0055
70935635|NCT03692871|141372126|OTHER||Difference in Percentage|7.9|||=|0.003|TWO_SIDED|95.0|2.8|12.8|||Miettinen & Nurminen method|||Injection-site erythema||12.8|2.8|= 0.003
70935636|NCT03692871|141372126|OTHER||Difference in Percentage|-0.3|||=|0.882|TWO_SIDED|95.0|-5.0|4.0|||Miettinen & Nurminen method|||Injection-site induration||4.0|-5.0|= 0.882
70935637|NCT03692871|141372126|OTHER||Difference in Percentage|6.4|||=|0.014|TWO_SIDED|95.0|1.3|11.3|||Miettinen & Nurminen method|||Injection-site pain||11.3|1.3|= 0.014
70935638|NCT03692871|141372126|OTHER||Difference in Percentage|4.6|||=|0.051|TWO_SIDED|95.0|0.0|8.9|||Miettinen & Nurminen method|||Injection-site swelling||8.9|0.0|= 0.051
70935639|NCT03692871|141372127|OTHER||Difference in Percentage|5.5|||=|0.033|TWO_SIDED|95.0|0.4|10.5|||Miettinen & Nurminen method|||Decreased appetite||10.5|0.4|= 0.033
70935640|NCT03692871|141372127|OTHER||Difference in Percentage|5.6|||=|0.016|TWO_SIDED|95.0|1.0|10.5|||Miettinen & Nurminen method|||Irritability||10.5|1.0|= 0.016
70935641|NCT03692871|141372127|OTHER||Difference in Percentage|0.4|||=|0.878|TWO_SIDED|95.0|-4.7|5.6|||Miettinen & Nurminen method|||Somnolence||5.6|-4.7|= 0.878
70935642|NCT03692871|141372127|OTHER||Difference in Percentage|-0.8|||=|0.503|TWO_SIDED|95.0|-3.8|1.5|||Miettinen & Nurminen method|||Urticaria||1.5|-3.8|= 0.503
70935643|NCT03692871|141372128|OTHER||Difference in Percentage|0.1|||||TWO_SIDED|95.0|-0.8|0.4||||||Percentage of participants with a vaccine-related SAE||0.4|-0.8|
70935644|NCT01316913|141372136|SUPERIORITY_OR_OTHER||Least squares mean difference|0.022||||0.377|TWO_SIDED|95.0|-0.027|0.072|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus UMEC 125 µg.|||0.072|-0.027|0.377
70935645|NCT01316913|141372136|SUPERIORITY_OR_OTHER||Least squares mean difference|0.06||||0.018|TWO_SIDED|95.0|0.01|0.109||nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus TIO 18 µg.|||0.109|0.010|0.018
70935646|NCT01316913|141372136|SUPERIORITY_OR_OTHER||Least squares mean difference|0.037||||0.142|TWO_SIDED|95.0|-0.012|0.087|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 µg minus UMEC 125 µg.|||0.087|-0.012|0.142
70935647|NCT01316913|141372136|SUPERIORITY_OR_OTHER||Least squares mean difference|0.074||||0.003|TWO_SIDED|95.0|0.025|0.123|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 µg minus TIO 18 µg.|||0.123|0.025|0.003
70935648|NCT02691702|141372166|OTHER|MMRM|Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|37.24|||TWO_SIDED|90.0|-63.09|60.57|||||Test (Melatonin 0.5 mg PM) Reference (Placebo)|||60.57|-63.09|
70935649|NCT02691702|141372166|OTHER|MMRM|Mean Difference (Final Values)|-27.13|STANDARD_ERROR_OF_MEAN|38.61|||TWO_SIDED|90.0|-91.24|36.97|||||Test (PF-05251749 50 mg AM) Reference (Placebo)|||36.97|-91.24|
70935650|NCT02691702|141372166|OTHER|MMRM|Mean Difference (Final Values)|43.72|STANDARD_ERROR_OF_MEAN|45.72|||TWO_SIDED|90.0|-32.19|119.62|||||Test (PF-05251749 100 mg AM) Reference (Placebo)|||119.62|-32.19|
70935651|NCT02691702|141372166|OTHER|MMRM|Mean Difference (Final Values)|61.48|STANDARD_ERROR_OF_MEAN|40.88|||TWO_SIDED|90.0|-6.38|129.35|||||Test (PF-05251749 200 mg AM) Reference (Placebo)|||129.35|-6.38|
70935652|NCT02691702|141372166|OTHER|MMRM|Mean Difference (Final Values)|125.87|STANDARD_ERROR_OF_MEAN|39.37|||TWO_SIDED|90.0|60.51|191.23|||||Test (PF-05251749 400 mg AM) Reference (Placebo)|||191.23|60.51|
70935653|NCT02691702|141372166|OTHER|MMRM|Mean Difference (Final Values)|156.22|STANDARD_ERROR_OF_MEAN|42.91|||TWO_SIDED|90.0|84.99|227.45|||||Test (PF-05251749 750 mg AM) Reference (Placebo)|||227.45|84.99|
71026517|NCT02041702|141560419|NON_INFERIORITY|The 2-sided 90% CI for difference in success rate between 2 groups was calculated by Farrington-Manning method.|Ratio Difference|-0.9||||0.0007|TWO_SIDED|90.0|-5.6|3.8|||Farrington-Manning Test||The null hypothesis would be rejected if the lower bound of the two-sided 90% confidence interval was greater than -10%.|"The hypothesis was: H0: PMRI - PCTRL≤ -10% vs H1: PMRI - PCTRL\>-10%~* PMRI: the success rate in the Cardiac MRI scan group for the change in right atrial capture threshold @0.5ms at 1month post MRI compared to pre-MRI scan value collected at MRI scan visit~* PCTRL: the success rate in the Control group for the change in right atrial capture threshold @0.5ms at 1month post MRI compared to pre-MRI scan value collected at MRI scan visit"||3.8|-5.6|0.0007
71026518|NCT02041702|141560420|NON_INFERIORITY|The 2-sided 90% CI for difference in success rate between 2 groups was calculated by Farrington-Manning method.|Ratio Difference|-1.7||||0.0012|TWO_SIDED|90.0|-6.2|2.8|||Farrington-Manning test||The null hypothesis would be rejected if the lower bound of the two-sided 90% confidence interval was greater than -10%.|"The hypothesis was: H0: PMRI - PCTRL≤ -10% vs H1: PMRI - PCTRL \>-10%~* PMRI: the success rate in the Cardiac MRI Scan Group for change in RV capture threshold value @0.5ms at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit~* PCTRL: the success rate in Control Group for change in RV capture threshold value @0.5ms at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit"||2.8|-6.2|0.0012
71026519|NCT02041702|141560421|NON_INFERIORITY|The 2-sided 90% CI for difference in success rate between 2 groups was calculated by Farrington-Manning method.|Ratio Difference|-2.7||||0.0446|TWO_SIDED|90.0|-9.8|4.3|||Farrington-Manning test||The null hypothesis would be rejected if the lower bound of the two-sided 90% confidence interval was greater than -10%.|"The hypothesis was:H0: PMRI - PCTRL≤ -10% vs H1: PMRI - PCTRL \>-10%~* PMRI: the success rate in MRI Scan Group for change in RA sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit~* PCTRL: the success rate in Control Group for change in RA sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit"||4.3|-9.8|0.0446
71059303|NCT03086551|141625515|OTHER||Effect Size - Cohen's d|0.38|||||TWO_SIDED||||||||Cohen's d was calculated as aggregate time to complete all elements at the pre-baseline assessment minus the aggregate time it took to complete all elements at the post-intervention assessment. The denominator reflected pooled variance.|The magnitude of transfer of the task specific practice to functional activities of daily live for the non-stroke affected limb was assessed by calculating the magnitude of change (Cohen's d) in time to complete the activities of the Jebsen-Taylor Hand Function Test from pre-baseline to post-intervention in the Active arm.||||
70935654|NCT02691702|141372166|OTHER|MMRM|Mean Difference (Final Values)|51.42|STANDARD_ERROR_OF_MEAN|33.12|||TWO_SIDED|90.0|-3.57|106.41|||||Test (PF-05251749 50 mg PM) Reference (Placebo)|||106.41|-3.57|
70935655|NCT02691702|141372166|OTHER|MMRM|Mean Difference (Final Values)|142.74|STANDARD_ERROR_OF_MEAN|36.13|||TWO_SIDED|90.0|82.76|202.72|||||Test (PF-05251749 200 mg PM) Reference (Placebo)|||202.72|82.76|
70935656|NCT02691702|141372166|OTHER|MMRM|Mean Difference (Final Values)|174.9|STANDARD_ERROR_OF_MEAN|36.01|||TWO_SIDED|90.0|115.11|234.69|||||Test (PF-05251749 500 mg PM) Reference (Placebo)|||234.69|115.11|
70935657|NCT02691702|141372167|OTHER|MMRM|Mean Difference (Final Values)|-71.26|STANDARD_ERROR_OF_MEAN|37.24|||TWO_SIDED|90.0|-133.09|-9.43|||||Test (Melatonin 0.5 mg PM) Reference (Placebo)|||-9.43|-133.09|
70935658|NCT02691702|141372167|OTHER|MMRM|Mean Difference (Final Values)|-12.13|STANDARD_ERROR_OF_MEAN|38.61|||TWO_SIDED|90.0|-76.24|51.97|||||Test (PF-05251749 50 mg AM) Reference (Placebo)|||51.97|-76.24|
70935659|NCT02691702|141372167|OTHER|MMRM|Mean Difference (Final Values)|88.72|STANDARD_ERROR_OF_MEAN|45.72|||TWO_SIDED|90.0|12.81|164.62|||||Test (PF-05251749 100 mg AM) Reference (Placebo)|||164.62|12.81|
70935660|NCT02691702|141372167|OTHER|MMRM|Mean Difference (Final Values)|46.48|STANDARD_ERROR_OF_MEAN|40.88|||TWO_SIDED|90.0|-21.38|114.35|||||Test (PF-05251749 200 mg AM) Reference (Placebo)|||114.35|-21.38|
70935661|NCT02691702|141372167|OTHER|MMRM|Mean Difference (Final Values)|87.3|STANDARD_ERROR_OF_MEAN|39.37|||TWO_SIDED|90.0|21.94|152.66|||||Test (PF-05251749 400 mg AM) Reference (Placebo)|||152.66|21.94|
71026520|NCT02041702|141560422|NON_INFERIORITY|The 2-sided 90% CI for difference in success rate between 2 groups was calculated by Farrington-Manning method.|Ratio Difference|2.6||||0.0002|TWO_SIDED|90.0|-3.2|8.4|||Farrington-Manning test||The null hypothesis would be rejected if the lower bound of the two-sided 90% confidence interval was greater than -10%.|"The hypothesis was: H0: PMRI - PCTRL≤ -10% vs H1: PMRI - PCTRL \>-10%~* PMRI: the success rate in the Cardiac MRI Scan Group for change in RV sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit~* PCTRL: the success rate in the Control Group for change in RV sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit"||8.4|-3.2|0.0002
71026521|NCT01488578|141560431|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71026522|NCT01488578|141560434|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.032|TWO_SIDED||||||Chi-squared|||||||=0.032
71059304|NCT03086551|141625515|OTHER||Effect Size - Cohen's d|0.08|||||TWO_SIDED||||||||Cohen's d was calculated as aggregate time to complete all elements at the pre-baseline assessment minus the aggregate time it took to complete all elements at the post-intervention assessment. The denominator reflected pooled variance.|The magnitude of transfer of the task specific practice to functional activities of daily live for the non-stroke affected limb was assessed by calculating the magnitude of change (Cohen's d) in time to complete the activities of the Jebsen-Taylor Hand Function Test from pre-baseline to post-intervention in the Sham arm.||||
71059305|NCT03086551|141625515|OTHER||Effect Size - Cohen's d|0.38|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to post-intervention for the Active arm minus the change from pre- to post-intervention for the Sham arm. The denominator reflected pooled variance.|Comparison across study arm of the magnitude of improvement in aggregate time to complete all elements of the Jebsen-Taylor Hand Function Test for the non-stroke affected limb. Cohen's d was calculated as a measure of effect size.||||
71059306|NCT03086551|141625516|OTHER||Effect Size - Cohen's d|-0.86|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to immediately post-stimulation (within the same session) for the Active arm minus the change from pre- to immediately post-stimulation for the Sham arm. The denominator reflected pooled variance.|The immediate effect of continuous theta burst stimulation over dorsolateral prefrontal cortex prior to practice was assessed by determining the magnitude of the effect of Active stimulation from pre-intervention to immediately post-intervention in Session 1 of the intervention. Cohen's d was used to derive effect size. The Sham stimulation change was used as the control.||||
71059307|NCT03086551|141625516|OTHER||Effect Size - Cohen's d|-0.04|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to immediately post-stimulation (within the same session) for the Active arm minus the change from pre- to immediately post-stimulation for the Sham arm. The denominator reflected pooled variance.|The immediate effect of continuous theta burst stimulation over dorsolateral prefrontal cortex prior to practice was assessed by determining the magnitude of the effect of Active stimulation from pre-intervention to immediately post-intervention in Session 2 of the intervention. Cohen's d was used to derive effect size. The Sham stimulation change was used as the control.||||
71059308|NCT03086551|141625516|OTHER||Effect Size - Cohen's d|-0.69|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to immediately post-stimulation (within the same session) for the Active arm minus the change from pre- to immediately post-stimulation for the Sham arm. The denominator reflected pooled variance.|The immediate effect of continuous theta burst stimulation over dorsolateral prefrontal cortex prior to practice was assessed by determining the magnitude of the effect of Active stimulation from pre-intervention to immediately post-intervention in Session 3 of the intervention. Cohen's d was used to derive effect size. The Sham stimulation change was used as the control.||||
71059309|NCT03086551|141625516|OTHER||Effect Size - Cohen's d|0.28|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to immediately post-stimulation (within the same session) for the Active arm minus the change from pre- to immediately post-stimulation for the Sham arm. The denominator reflected pooled variance.|The immediate effect of continuous theta burst stimulation over dorsolateral prefrontal cortex prior to practice was assessed by determining the magnitude of the effect of Active stimulation from pre-intervention to immediately post-intervention in Session 4 of the intervention. Cohen's d was used to derive effect size. The Sham stimulation change was used as the control.||||
71059310|NCT03086551|141625517|OTHER||Effect Size - Cohen's d|-0.31|||||TWO_SIDED||||||||Cohen's d was calculated as the amplitude of the motor evoked potential at the post-intervention assessment minus the amplitude of the motor evoked potential at the pre-baseline assessment. The denominator reflected pooled variance.|Comparison of first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention for the Active arm when transcranial magnetic stimulator intensity was set to 120% of resting motor threshold. Estimate of effect size was derived using Cohen's d.||||
71059311|NCT03086551|141625517|OTHER||Effect Size - Cohen's d|-0.85|||||TWO_SIDED||||||||Cohen's d was calculated as the amplitude of the motor evoked potential at the post-intervention assessment minus the amplitude of the motor evoked potential at the pre-baseline assessment. The denominator reflected pooled variance.|Comparison of first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention for the Sham arm when transcranial magnetic stimulator intensity was set to 120% of resting motor threshold. Estimate of effect size was derived using Cohen's d.||||
71059312|NCT03086551|141625517|OTHER||Effect Size - Cohen's d|-0.35|||||TWO_SIDED||||||||Cohen's d was calculated as the amplitude of the motor evoked potential at the post-intervention assessment minus the amplitude of the motor evoked potential at the pre-baseline assessment. The denominator reflected pooled variance.|Comparison of the first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention for the Active arm when transcranial magnetic stimulator intensity was set to 150% of resting motor threshold. Estimate of effect size was derived using Cohen's d.||||
71026523|NCT01488578|141560435|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71026524|NCT01488578|141560436|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71026525|NCT01488578|141560437|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71109394|NCT01822665|141724227|SUPERIORITY_OR_OTHER||LS mean difference|0.26||||0.2227|TWO_SIDED|95.0|-0.16|0.67||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments||0.67|-0.16|0.2227
71109395|NCT01822665|141724227|SUPERIORITY_OR_OTHER||LS mean difference|0.23||||0.2855|TWO_SIDED|95.0|-0.2|0.65||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments.||0.65|-0.20|0.2855
71109396|NCT01822665|141724228|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.19||||0.0084|TWO_SIDED|95.0|1.6|23.97||P-value associated with chi-square testing odds ratio.|Chi-squared||Odds Ratio from logistic regression model with treatment as factor and period as covariate.|||23.97|1.60|0.0084
70935662|NCT02691702|141372167|OTHER|MMRM|Mean Difference (Final Values)|126.22|STANDARD_ERROR_OF_MEAN|42.91|||TWO_SIDED|90.0|54.99|197.45|||||Test (PF-05251749 750 mg AM) Reference (Placebo)|||197.45|54.99|
71026526|NCT01488578|141560438|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||The Hosmer-Lemeshow Goodness-of-Fit TEST|||||||<0.001
71026527|NCT01488578|141560440|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.006|TWO_SIDED||||||Chi-squared|||||||=0.006
71026528|NCT01488578|141560441|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71026529|NCT01488578|141560442|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.015|TWO_SIDED||||||Chi-squared|||||||=0.015
71026530|NCT01488578|141560443|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71026531|NCT01488578|141560444|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71026532|NCT02308111|141560446|SUPERIORITY||Hazard Ratio, log|1.01||||0.954|TWO_SIDED|95.0|0.68|1.51||Log rank p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the interactive web response system (IWRS) as strata|Log Rank|||||1.51|0.68|0.954
71026533|NCT02308111|141560447|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.304|TWO_SIDED|95.0|0.61|1.16||Log rank p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Log Rank|||||1.16|0.61|0.304
71026534|NCT02308111|141560448|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.898|TWO_SIDED|95.0|0.69|1.52||Log rank p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Log Rank|||||1.52|0.69|0.898
71026535|NCT02308111|141560449|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.594|TWO_SIDED|95.0|0.69|1.91||Log rank p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Log Rank|||||1.91|0.69|0.594
71026536|NCT02308111|141560450|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.568|TWO_SIDED|95.0|0.57|2.78||Log rank p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Log Rank|||||2.78|0.57|0.568
71026537|NCT02308111|141560451|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.769|TWO_SIDED|95.0|0.59|2.07||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the interactive web response system (IWRS) as strata.|Gray's Test|||||2.07|0.59|0.769
71026538|NCT02308111|141560452|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.599|TWO_SIDED|95.0|0.42|1.67||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||1.67|0.42|0.599
71026539|NCT02308111|141560453|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.745|TWO_SIDED|95.0|0.18|3.43||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||3.43|0.18|0.745
71026540|NCT02308111|141560454|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.437|TWO_SIDED|95.0|0.43|1.44||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||1.44|0.43|0.437
71026541|NCT02308111|141560455|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.838|TWO_SIDED|95.0|0.37|2.24||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||2.24|0.37|0.838
71026542|NCT02308111|141560456|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.98|TWO_SIDED|95.0|0.26|4.04||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||4.04|0.26|0.980
71026543|NCT02308111|141560457|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.933|TWO_SIDED|95.0|0.58|1.83||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||1.83|0.58|0.933
71026544|NCT02308111|141560458|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.468|TWO_SIDED|95.0|0.53|1.34||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||1.34|0.53|0.468
71026545|NCT02308111|141560459|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.178|TWO_SIDED|95.0|0.13|1.41||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||1.41|0.13|0.178
71026546|NCT02308111|141560459|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.19|TWO_SIDED|95.0|0.13|1.41|||Cochran-Mantel-Haenszel|||||1.41|0.13|0.190
71026547|NCT02308111|141560460|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.443|TWO_SIDED|95.0|0.05|3.54||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||3.54|0.05|0.443
71026548|NCT03977584|141560620|SUPERIORITY||Difference in Annualized Rate of Change|-0.013|STANDARD_ERROR_OF_MEAN|0.00993||0.1953|TWO_SIDED|95.0|-0.0327|0.0068|||RCRM|||Analysis was based on RCRM using unstructured covariance matrix: GTP1 PET = Treatment \* Analysis Year + Interactive Voice or Web Response System (IxRS) defined Age Group + IxRS defined Education History + IxRS defined apolipoprotein (APOE4) Carrier Status + IxRS defined Clinical Dementia Rating Global Score.||0.0068|-0.0327|0.1953
70935663|NCT02691702|141372167|OTHER|MMRM|Mean Difference (Final Values)|92.36|STANDARD_ERROR_OF_MEAN|35.48|||TWO_SIDED|90.0|33.51|151.21|||||Test (PF-05251749 50 mg PM) Reference (Placebo)|||151.21|33.51|
71026549|NCT01835145|141560635|SUPERIORITY|||||||0.7|||||||Chi-squared|||A one-sided chi-squared test for a difference in PFS4 rates will be used to test for a difference between arms.||||0.70
71026550|NCT03482713|141560692|OTHER||Difference in least squares means|0.79|||||TWO_SIDED|95.0|-0.34|1.93|||||Based on an ANCOVA model with terms for treatment, gender and the log-transformed baseline.|||1.93|-0.34|
71026551|NCT03482713|141560693|OTHER||Difference least squares mean|0.76|||||TWO_SIDED|95.0|-0.35|1.88|||||Based on an ANCOVA model with terms for treatment, gender and the log-transformed baseline.|||1.88|-0.35|
71026552|NCT02146430|141560694|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.187||0.187|TWO_SIDED|95.0|-0.61|0.12|||Difference of means|||||0.12|-0.61|0.1870
71026553|NCT02146430|141560694|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.185||0.0944|TWO_SIDED|95.0|-0.67|0.05|||Difference of means|||||0.05|-0.67|0.0944
71026554|NCT02146430|141560694|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.187||0.1391|TWO_SIDED|95.0|-0.64|0.09|||Difference of means|||||0.09|-0.64|0.1391
71026555|NCT02146430|141560694|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.187||0.7338|TWO_SIDED|95.0|-0.43|0.3|||Difference of means|||||0.30|-0.43|0.7338
71026556|NCT02146430|141560694|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.19||0.8705|TWO_SIDED|95.0|-0.4|0.34|||Difference of means|||||0.34|-0.40|0.8705
71026557|NCT02146430|141560696|SUPERIORITY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|1.592||0.0326|TWO_SIDED|95.0|-6.52|-0.28|||Difference of means|||||-0.28|-6.52|0.0326
71026558|NCT02146430|141560696|SUPERIORITY||Mean Difference (Final Values)|-1.28|STANDARD_ERROR_OF_MEAN|1.592||0.422|TWO_SIDED|95.0|-4.4|1.84|||Difference of means|||||1.84|-4.40|0.4220
71026559|NCT02146430|141560696|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|1.615||0.9659|TWO_SIDED|95.0|-3.1|3.23|||Difference of means|||||3.23|-3.10|0.9659
71026560|NCT02146430|141560696|SUPERIORITY||Mean Difference (Final Values)|2.12|STANDARD_ERROR_OF_MEAN|1.608||0.1867|TWO_SIDED|95.0|-1.03|5.28|||Difference of means|||||5.28|-1.03|0.1867
71026561|NCT02146430|141560696|SUPERIORITY||Mean Difference (Final Values)|3.47|STANDARD_ERROR_OF_MEAN|1.631||0.0333|TWO_SIDED|95.0|0.27|6.67|||Difference of means|||||6.67|0.27|0.0333
71026562|NCT02146430|141560698|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.28||0.2474|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|||||0.2|-0.9|0.2474
71109397|NCT01822665|141724228|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.19||||0.0999|TWO_SIDED|95.0|0.8|12.74||P-value associated with chi-square testing odds ratio.|Chi-squared||Odds Ratio from logistic regression model with treatment as factor and period as covariate.|||12.74|0.80|0.0999
70935664|NCT02691702|141372167|OTHER|MMRM|Mean Difference (Final Values)|107.29|STANDARD_ERROR_OF_MEAN|36.13|||TWO_SIDED|90.0|47.31|167.27|||||Test (PF-05251749 200 mg AM) Reference (Placebo)|||167.27|47.31|
70935665|NCT02691702|141372167|OTHER|MMRM|Mean Difference (Final Values)|140.61|STANDARD_ERROR_OF_MEAN|37.79|||TWO_SIDED|90.0|77.91|203.3|||||Test (PF-05251749 500 mg AM) Reference (Placebo)|||203.30|77.91|
71026563|NCT02146430|141560698|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.28||0.3347|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||||0.3|-0.8|0.3347
71026564|NCT02146430|141560698|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.28||0.3999|TWO_SIDED|95.0|-0.3|0.8|||ANCOVA|||||0.8|-0.3|0.3999
71026565|NCT02146430|141560698|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.28||0.8435|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||||0.6|-0.5|0.8435
71026566|NCT02146430|141560698|SUPERIORITY||Difference in least squares means|0.6|STANDARD_ERROR_OF_MEAN|0.28||0.0446|TWO_SIDED|95.0|0.0|1.1|||ANCOVA|||||1.1|0.0|0.0446
71026567|NCT02146430|141560699|SUPERIORITY||Difference of least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.24||0.9775|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Anxiety: Placebo vs Pregabalin 150 mg BID||0.5|-0.5|0.9775
71026568|NCT02146430|141560699|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.65|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||Anxiety: Placebo vs DS-5565 15 mg QD||0.4|-0.6|0.6500
71026569|NCT02146430|141560699|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.6546|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||Anxiety: Placebo vs DS-5565 15 mg BID||0.4|-0.6|0.6546
71026570|NCT02146430|141560699|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.6692|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||Anxiety: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.4|-0.6|0.6692
71026571|NCT02146430|141560699|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.6737|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||Anxiety: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.4|-0.6|0.6737
71026572|NCT02146430|141560699|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.27||0.3888|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||Depression: Placebo vs Pregabalin 150 mg BID||0.3|-0.8|0.3888
71026573|NCT02146430|141560699|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.27||0.92|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||Depression: Placebo vs DS-5565 15 mg QD||0.6|-0.5|0.9200
71026574|NCT02146430|141560699|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.27||0.7061|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||Depression: Placebo vs DS-5565 15 mg BID||0.6|-0.4|0.7061
71026575|NCT02146430|141560699|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.3337|TWO_SIDED|95.0|-0.3|0.8|||ANCOVA|||Depression: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|-0.3|0.3337
71026576|NCT02146430|141560699|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.2139|TWO_SIDED|95.0|-0.2|0.9|||ANCOVA|||Depression: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.9|-0.2|0.2139
71026577|NCT02146430|141560700|SUPERIORITY||Difference in least squares means|2.197|STANDARD_ERROR_OF_MEAN|1.4933||0.1416|TWO_SIDED|95.0|-0.733|5.126|||ANCOVA|||Physical Component: Placebo vs Pregabalin 150 mg BID||5.126|-0.733|0.1416
71026578|NCT02146430|141560700|SUPERIORITY||Difference in least squares means|0.249|STANDARD_ERROR_OF_MEAN|1.492||0.8677|TWO_SIDED|95.0|-2.679|3.176|||ANCOVA|||Physical Component: Placebo vs DS-5565 15 mg QD||3.176|-2.679|0.8677
71026579|NCT02146430|141560700|SUPERIORITY||Difference in least squares means|-0.899|STANDARD_ERROR_OF_MEAN|1.4959||0.5481|TWO_SIDED|95.0|-3.834|2.036|||ANCOVA|||Physical Component: Placebo vs DS-5565 15 mg BID||2.036|-3.834|0.5481
71109398|NCT01822665|141724228|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.94||||0.2845|TWO_SIDED|95.0|0.58|6.5|||Chi-squared||Odds Ratio from logistic regression model with treatment as factor and period as covariate.|||6.50|0.58|0.2845
70935666|NCT02060487|141372186|NON_INFERIORITY|Non-inferiority of sildenafil 20 mg TID versus sildenafil 5 mg TID was to be concluded if the upper limit of the 99.7% confidence interval (CI) for hazard ratio (HR) was less than 2.|Hazard Ratio (HR)|0.68|||||TWO_SIDED|99.7|0.31|1.49|||||Hazard ratio estimated from the Proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH.|||1.49|0.31|
71059313|NCT03086551|141625517|OTHER||Effect Size - Cohen's d|1.13|||||TWO_SIDED||||||||Cohen's d was calculated as the amplitude of the motor evoked potential at the post-intervention assessment minus the amplitude of the motor evoked potential at the pre-baseline assessment. The denominator reflected pooled variance.|Comparison of the first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention for the Sham arm when transcranial magnetic stimulator intensity was set to 150% of resting motor threshold. Estimate of effect size was derived using Cohen's d.||||
71059314|NCT03086551|141625518|OTHER||Effect Size - Cohen's d|-0.15|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to post-intervention for the Active arm minus the change from pre- to post-intervention for the Sham arm. The denominator reflected pooled variance.|Comparison of the first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention across the Active and Sham arms when transcranial magnetic stimulator intensity was set to 120% of resting motor threshold. Comparison quantified as effect size using Cohen's d.||||
71059315|NCT03086551|141625518|OTHER||Effect Size - Cohen's d|-1.46|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to post-intervention for the Active arm minus the change from pre- to post-intervention for the Sham arm. The denominator reflected pooled variance.|Comparison of the first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention across the Active and Sham arms when transcranial magnetic stimulator intensity was set to 150% of resting motor threshold. Comparison quantified as effect size using Cohen's d.||||
71059316|NCT02201277|141625554|SUPERIORITY|||||||1|||||||t-test, 2 sided|||A Fisher's exact test was used to determine if there was a difference in the numbers of filters with penetration for each type. The numbers were not powered enough to make extensive tests in this area meaningful.||||1.0
71059317|NCT02201277|141625554|EQUIVALENCE|rate of penetration||||||1|||||||t-test, 1 sided|||||||1.0
71059318|NCT00489255|141625562|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.09|TWO_SIDED|95.0|0.17|1.11|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test for treatment was stratified by site.||The null hypothesis was no difference between treatments.||1.11|0.17|0.09
71059319|NCT00489255|141625563|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.44||||0.025|TWO_SIDED|95.0|0.21|0.9|||Cochran-Mantel-Haenszel|||||0.90|0.21|0.025
71059320|NCT00489255|141625564|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.25||||0.005|TWO_SIDED|95.0|0.09|0.7|||Cochran-Mantel-Haenszel|||||0.70|0.09|0.005
71059321|NCT00489255|141625565|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.65|TWO_SIDED|95.0|0.23|2.48|||Cochran-Mantel-Haenszel|||||2.48|0.23|0.65
71059322|NCT00489255|141625566|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.21||||0.32|TWO_SIDED|95.0|-0.64|0.21|||ANOVA|Treatment effect in ANOVA was adjusted for site.||||0.21|-0.64|0.32
71059323|NCT00489255|141625567|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.07||||0.001|TWO_SIDED|95.0|-1.71|-0.43|||ANOVA|||||-0.43|-1.71|0.001
71059324|NCT00489255|141625568|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.01||||0.95|TWO_SIDED|95.0|-0.2|0.19|||ANOVA|||||0.19|-0.20|0.95
71059325|NCT00489255|141625569|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test (row mean score) with rigid scores, stratified by site||||||0.88
71059326|NCT00489255|141625570|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test (row mean score) with rigid scores, stratified by site||||||0.019
71059327|NCT00489255|141625571|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Cochran-Mantel-Haenszel|||||||0.29
71059328|NCT00489255|141625572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.17|TWO_SIDED|95.0|0.5|1.1||Cox's proportional hazards model with site and treatment (Tigan/placebo) as factors.|Regression, Cox|||||1.1|0.5|0.17
71059329|NCT00489255|141625573|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.008|TWO_SIDED|95.0|0.1|0.7||Cox's proportional hazards model with site and treatment (Tigan/placebo) as factors.|Regression, Cox|||||0.7|0.1|0.008
71059330|NCT00489255|141625574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.49|TWO_SIDED|95.0|0.6|1.3||Cox's proportional hazards model with site and treatment (Tigan/placebo) as factors.|Regression, Cox|||||1.3|0.6|0.49
71059331|NCT00489255|141625575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.4|TWO_SIDED|95.0|0.7|2.1|||Regression, Cox|||||2.1|0.7|0.4
71109399|NCT00959907|141724232|SUPERIORITY_OR_OTHER|||||||0.832||95.0|||||t-test, 2 sided|||||||0.832
71109400|NCT00959907|141724233|SUPERIORITY_OR_OTHER|||||||0.658||95.0|||||t-test, 2 sided|||||||0.658
70935667|NCT02060487|141372186|NON_INFERIORITY|Non-inferiority of sildenafil 80 mg TID vs. sildenafil 5 mg TID was to be concluded if the upper limit of the 99.7% CI for HR was less than 2.|Hazard Ratio (HR)|0.51|||||TWO_SIDED|99.7|0.22|1.21|||||Hazard ratio estimated from the Proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH.|||1.21|0.22|
71059332|NCT00489255|141625576|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.62||95.0|0.6|2.3||Cox's proportional hazards model with site and treatment (Tigan/placebo) as factors.|Regression, Cox|||||2.3|0.6|0.62
71059333|NCT00489255|141625577|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.96|TWO_SIDED|95.0|-3.59|3.76|||ANOVA|ANCOVA model with baseline score (score at Visit 1/Screening) as a covariate, and site and treatment as factors.||||3.76|-3.59|0.96
71059334|NCT00489255|141625578|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.93|TWO_SIDED|95.0|-4.37|4.02|||ANOVA|||||4.02|-4.37|0.93
71059335|NCT00489255|141625579|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.84|TWO_SIDED|95.0|-4.12|3.34|||ANOVA|||||3.34|-4.12|0.84
71059336|NCT00489255|141625580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.97||||0.25|TWO_SIDED|95.0|-2.17|8.11|||ANOVA|||||8.11|-2.17|0.25
71109401|NCT00959907|141724233|SUPERIORITY_OR_OTHER|||||||0.739||95.0|||||t-test, 2 sided|||||||0.739
71109402|NCT00959907|141724234|SUPERIORITY_OR_OTHER|||||||0.184||95.0|||||t-test, 2 sided|||||||0.184
71059337|NCT00489255|141625581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.47||||0.46|TWO_SIDED|95.0|-2.47|5.4|||ANOVA|||||5.40|-2.47|0.46
71059338|NCT00489255|141625582|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.96||||0.33|TWO_SIDED|95.0|-3.13|9.06|||ANOVA|||||9.06|-3.13|0.33
71059339|NCT00489255|141625583|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27||||0.93|TWO_SIDED|95.0|-5.57|6.11|||ANOVA|||||6.11|-5.57|0.93
71059340|NCT01512160|141625602|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|90.0|-4.3|2.2||||||Analysis of co-variance (ANCOVA) model was used with treatment as a fixed effect and baseline pain intensity as a covariate. LS mean estimates of the treatment difference along with 90 percent (%) confidence interval (CI) was presented.||2.2|-4.3|
71059341|NCT01512160|141625602|SUPERIORITY_OR_OTHER||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|90.0|-4.1|2.3||||||ANCOVA model was used with treatment as a fixed effect and baseline pain intensity as a covariate. LS mean estimates of the treatment difference along with 90% CI was presented.||2.3|-4.1|
71059342|NCT01512160|141625602|SUPERIORITY_OR_OTHER||LS mean difference|3.5|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|90.0|0.3|6.7||||||ANCOVA model was used with treatment as a fixed effect and baseline pain intensity as a covariate. LS mean estimates of the treatment difference along with 90% CI was presented.||6.7|0.3|
71059343|NCT01512160|141625606|SUPERIORITY_OR_OTHER||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|90.0|-2.8|1.9||||||SPID 0-6: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||1.9|-2.8|
71059344|NCT01512160|141625606|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|90.0|-2.7|2.0||||||SPID 0-6: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||2.0|-2.7|
71059345|NCT01512160|141625606|SUPERIORITY_OR_OTHER||LS mean difference|2.8|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|90.0|0.4|5.1||||||SPID 0-6: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||5.1|0.4|
71059346|NCT01512160|141625606|SUPERIORITY_OR_OTHER||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|7.0|||TWO_SIDED|90.0|-12.6|10.5||||||SPID 0-24: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||10.5|-12.6|
71109403|NCT01722929|141724235|OTHER||||||<|0.0001||||||p-value is for the main effect for the Treatment, Time, and Treatment\*Time interaction.|Mixed Models Analysis|||A mixed ANOVA was performed with the arms as a between factor and the three times as the within factor.||||<0.0001
71059347|NCT01512160|141625606|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|6.9|||TWO_SIDED|90.0|-11.5|11.4||||||SPID 0-24: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||11.4|-11.5|
71059348|NCT01512160|141625606|SUPERIORITY_OR_OTHER||LS mean difference|7.6|STANDARD_ERROR_OF_MEAN|7.0|||TWO_SIDED|90.0|-4.0|19.1||||||SPID 0-24: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||19.1|-4.0|
71059349|NCT01512160|141625607|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|9.5|||TWO_SIDED|90.0|-15.6|16.1||||||LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||16.1|-15.6|
71059350|NCT01512160|141625607|SUPERIORITY_OR_OTHER||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|9.4|||TWO_SIDED|90.0|-16.5|14.8||||||LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||14.8|-16.5|
71059351|NCT01512160|141625607|SUPERIORITY_OR_OTHER||LS mean difference|9.3|STANDARD_ERROR_OF_MEAN|9.5|||TWO_SIDED|90.0|-6.6|25.1||||||LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||25.1|-6.6|
71059352|NCT01512160|141625608|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|90.0|0.5|1.5||||||Hazard Ratio (HR) estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.5|0.5|
71059353|NCT01512160|141625608|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2|||||TWO_SIDED|90.0|0.7|2.1||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||2.1|0.7|
71109404|NCT01847443|141724250|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was to be established between the test and reference treatment if the 90% CI of ratio of geometric means (Test/Reference) was included within the bioequivalence limits of (0.80, 1.25)|Ratio of Geometric means|1.107|||||TWO_SIDED|90.0|1.07|1.147|||ANOVA|||Null hypothesis stated that there was no difference between the test and reference gums in AUC(0-t)||1.147|1.070|
71109405|NCT01847443|141724255|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was to be established between the test and reference treatment if the 90% CI of ratio of geometric means (Test/Reference) was included within the bioequivalence limits of (0.80, 1.25)|Ratio of Geometric means|1.098|||||TWO_SIDED|90.0|1.061|1.137|||ANOVA|||Null hypothesis stated that there was no difference between the test and reference gums in AUC(0-t)||1.137|1.061|
71109406|NCT01847443|141724256|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was to be established between the test and reference treatment if the 90% CI of ratio of geometric means (Test/Reference) was included within the bioequivalence limits of (0.80, 1.25)|Ratio of Geometric means|1.044|||||TWO_SIDED|90.0|1.002|1.089|||ANOVA|||Null hypothesis stated that there was no difference between the test and reference gums in Cmax||1.089|1.002|
71109407|NCT01847443|141724257|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was to be established between the test and reference treatment if the 90% CI of ratio of geometric means (Test/Reference) was included within the bioequivalence limits of (0.80, 1.25)|Ratio of Geometric means|1.071|||||TWO_SIDED|90.0|1.028|1.116|||ANOVA|||Null hypothesis stated that there was no difference between the test and reference gums in Cmax||1.116|1.028|
71059354|NCT01512160|141625608|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|90.0|0.6|2.0||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||2.0|0.6|
70935668|NCT02060487|141372186|NON_INFERIORITY|Non-inferiority of sildenafil 80 mg TID vs. sildenafil 20 mg TID was to be concluded if the upper limit of the 99.7% CI for HR is less than 2.|Hazard Ratio (HR)|0.74|||||TWO_SIDED|99.7|0.3|1.84|||||Hazard ratio estimated from the Proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH.|||1.84|0.30|
70935669|NCT02060487|141372187|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.035|TWO_SIDED|99.7|0.33|1.21|||Wald test||Hazard ratio estimated from the Proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH.|||1.21|0.33|0.035
70935670|NCT02060487|141372187|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.001|TWO_SIDED|99.7|0.22|0.89|||Wald test||Hazard ratio estimated from the Proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH.|||0.89|0.22|<0.001
70935671|NCT02060487|141372187|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.195|TWO_SIDED|99.7|0.34|1.52|||Wald test||Hazard ratio estimated from the Proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH.|||1.52|0.34|0.195
71026580|NCT02146430|141560700|SUPERIORITY||Difference in least squares means|-1.948|STANDARD_ERROR_OF_MEAN|1.4875||0.1906|TWO_SIDED|95.0|-4.866|0.971|||ANCOVA|||Physical Component: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.971|-4.866|0.1906
71026581|NCT02146430|141560700|SUPERIORITY||Difference in least squares means|-3.095|STANDARD_ERROR_OF_MEAN|1.4883||0.0378|TWO_SIDED|95.0|-6.015|-0.175|||ANCOVA|||Physical Component: Pregabalin 150 mg BID vs DS-5565 15 mg BID||-0.175|-6.015|0.0378
71026582|NCT02146430|141560700|SUPERIORITY||Difference in least squares means|0.664|STANDARD_ERROR_OF_MEAN|0.6865||0.3337|TWO_SIDED|95.0|-0.683|2.011|||ANCOVA|||Mental Component: Placebo vs Pregabalin 150 mg BID||2.011|-0.683|0.3337
71026583|NCT02146430|141560700|SUPERIORITY||Difference in least squares means|-0.194|STANDARD_ERROR_OF_MEAN|0.686||0.7778|TWO_SIDED|95.0|-1.54|1.152|||ANCOVA|||Mental Component: Placebo vs DS-5565 15 mg QD||1.152|-1.540|0.7778
71026584|NCT02146430|141560700|SUPERIORITY||Difference in least squares means|-0.087|STANDARD_ERROR_OF_MEAN|0.6879||0.8991|TWO_SIDED|95.0|-1.437|1.262|||ANCOVA|||Mental Component: Placebo vs DS-5565 15 mg BID||1.262|-1.437|0.8991
71026585|NCT02146430|141560700|SUPERIORITY||Difference in least squares means|-0.857|STANDARD_ERROR_OF_MEAN|0.6833||0.2098|TWO_SIDED|95.0|-2.198|0.483|||ANCOVA|||Mental Component: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.483|-2.198|0.2098
71026586|NCT02146430|141560700|SUPERIORITY||Difference in least squares means|-0.751|STANDARD_ERROR_OF_MEAN|0.6842||0.2725|TWO_SIDED|95.0|-2.093|0.591|||ANCOVA|||Mental Component: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.591|-2.093|0.2725
71026587|NCT02146430|141560701|SUPERIORITY||Difference in least squares means|0.0018|STANDARD_ERROR_OF_MEAN|0.01329||0.8923|TWO_SIDED|95.0|-0.0243|0.0279|||ANCOVA|||||0.0279|-0.0243|0.8923
71026588|NCT02146430|141560701|SUPERIORITY||Difference in least squares means|-0.0021|STANDARD_ERROR_OF_MEAN|0.01327||0.8749|TWO_SIDED|95.0|-0.0281|0.024|||ANCOVA|||||0.0240|-0.0281|0.8749
71026589|NCT02146430|141560701|SUPERIORITY||Difference in least squares means|-0.0091|STANDARD_ERROR_OF_MEAN|0.01332||0.4932|TWO_SIDED|95.0|-0.0353|0.017|||ANCOVA|||||0.0170|-0.0353|0.4932
71059355|NCT01512160|141625609|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|90.0|0.5|2.1||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||2.1|0.5|
70935672|NCT02060487|141372188|SUPERIORITY||Least-squares means difference|15.0||||0.0627|TWO_SIDED|95.0|-0.8|30.81|||MMRM|||||30.81|-0.80|0.0627
70935673|NCT02060487|141372188|SUPERIORITY||Least-squares means difference|18.9||||0.0201|TWO_SIDED|95.0|2.99|34.86|||MMRM|||||34.86|2.99|0.0201
70935674|NCT02060487|141372188|SUPERIORITY||Least-squares means difference|3.9||||0.6254|TWO_SIDED|95.0|-11.85|19.68|||MMRM|||||19.68|-11.85|0.6254
70935675|NCT02060487|141372189|SUPERIORITY||Least-squares means difference|21.3||||0.0286|TWO_SIDED|95.0|2.25|40.45|||MMRM|||||40.45|2.25|0.0286
71026590|NCT02146430|141560701|SUPERIORITY||Difference in least squares means|-0.0039|STANDARD_ERROR_OF_MEAN|0.01323||0.7688|TWO_SIDED|95.0|-0.0298|0.0221|||ANCOVA|||||0.0221|-0.0298|0.7688
71026591|NCT02146430|141560701|SUPERIORITY||Difference in least squares means|-0.0109|STANDARD_ERROR_OF_MEAN|0.01326||0.4099|TWO_SIDED|95.0|-0.0369|0.0151|||ANCOVA|||||0.0151|-0.0369|0.4099
71026592|NCT02146430|141560702|SUPERIORITY||Difference in least squares means|-0.55|STANDARD_ERROR_OF_MEAN|0.166||0.0009|TWO_SIDED|95.0|-0.88|-0.23|||Mixed Models Analysis|||||-0.23|-0.88|0.0009
71026593|NCT02146430|141560702|SUPERIORITY||Difference in least squares means|-0.63|STANDARD_ERROR_OF_MEAN|0.166||0.0001|TWO_SIDED|95.0|-0.96|-0.31|||Mixed Models Analysis|||||-0.31|-0.96|0.0001
71026594|NCT02146430|141560702|SUPERIORITY||Difference in least squares means|-0.85|STANDARD_ERROR_OF_MEAN|0.167|<|0.0001|TWO_SIDED|95.0|-1.17|-0.52|||Mixed Models Analysis|||||-0.52|-1.17|<0.0001
71026595|NCT02146430|141560702|SUPERIORITY||Difference in least squares means|-0.08|STANDARD_ERROR_OF_MEAN|0.167||0.6408|TWO_SIDED|95.0|-0.4|0.25|||Mixed Models Analysis|||||0.25|-0.40|0.6408
71026596|NCT02146430|141560702|SUPERIORITY||Difference in least squares means|-0.29|STANDARD_ERROR_OF_MEAN|0.167||0.0786|TWO_SIDED|95.0|-0.62|0.03|||Mixed Models Analysis|||||0.03|-0.62|0.0786
71026597|NCT02146430|141560704|SUPERIORITY||Difference of least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.0541|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|||Worst pain: Placebo vs Pregabalin 150 mg BID||0.0|-0.7|0.0541
71026598|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.7771|TWO_SIDED|95.0|-0.4|0.3|||ANCOVA|||Worst pain: Placebo vs DS-5565 15 mg QD||0.3|-0.4|0.7771
71026599|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.5488|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Worst pain: Placebo vs DS-5565 15 mg BID||0.3|-0.5|0.5488
71026600|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.19||0.0987|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Worst pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.7|-0.1|0.0987
71109408|NCT03571971|141724258|SUPERIORITY|Based on published data, we conservatively estimated that the standard exercise (SE) group and load modification (LM) group would have a 20% and 50% treatment success rate, respectively. We defined treatment success as either: 1) at least 'moderately better' on the Global Rating of Change scale or 2) ≥2 point decrease on the Numeric Pain Rating Scale. With one-side type I error=0.1, power=80%, and allocation ratio is 1:1, we estimated the need for 22 participants in each group (total N=44).|Odds Ratio (OR)|1.09||||0.879|TWO_SIDED|95.0|0.36|3.35||The a priori threshold for statistical significance was set at 0.05.|Chi-squared|||||3.35|0.36|0.879
71109409|NCT03848455|141724270|OTHER||||||<|0.001|||||||Kruskal-Wallis|||we use the method of RT-PCR to detect the relative expression level of PPP2CA gene in Parkinson's disease group(90 participants), healthy controls group(125 participants) and Parkinson-plus syndrome group(23 participants).This gene expression is relative to a house keeping gene GAPDH.The data were processed using 2-△△Ct. ΔCT(test) = CT(target, test) - CT(ref, test), ΔCT(calibrator) = CT(target, calibrator) - CT(ref, calibrator),ΔΔCT = ΔCT(test) - ΔCT(calibrator).||||<0.001
71109410|NCT03848455|141724270|OTHER||||||<|0.001|||||||Kruskal-Wallis|||we use the method of RT-PCR to detect the relative expression level of SYNJ1 gene in Parkinson's disease group(90 participants), healthy controls group(125 participants) and Parkinson-plus syndrome group(23 participants).This gene expression is relative to a house keeping gene GAPDH.The data were processed using 2-△△Ct. ΔCT(test) = CT(target, test) - CT(ref, test), ΔCT(calibrator) = CT(target, calibrator) - CT(ref, calibrator),ΔΔCT = ΔCT(test) - ΔCT(calibrator).||||<0.001
71109411|NCT03848455|141724270|OTHER|||||||0.149|||||||Kruskal-Wallis|||we use the method of RT-PCR to detect the relative expression level of PPP3CB gene in Parkinson's disease group(90 participants), healthy controls group(125 participants) and Parkinson-plus syndrome group(23 participants).This gene expression is relative to a house keeping gene GAPDH.The data were processed using 2-△△Ct. ΔCT(test) = CT(target, test) - CT(ref, test), ΔCT(calibrator) = CT(target, calibrator) - CT(ref, calibrator),ΔΔCT = ΔCT(test) - ΔCT(calibrator).||||0.149
71109412|NCT03848455|141724270|OTHER||||||<|0.001|||||||Kruskal-Wallis|||we use the method of RT-PCR to detect the relative expression level of NSF gene in Parkinson's disease group(90 participants), healthy controls group(125 participants) and Parkinson-plus syndrome group(23 participants).This gene expression is relative to a house keeping gene GAPDH.The data were processed using 2-△△Ct. ΔCT(test) = CT(target, test) - CT(ref, test), ΔCT(calibrator) = CT(target, calibrator) - CT(ref, calibrator),ΔΔCT = ΔCT(test) - ΔCT(calibrator).||||<0.001
71109413|NCT04046939|141724273|SUPERIORITY||Ratio to PBO of the ratios to baseline|0.2283|||<|0.0001|TWO_SIDED|95.0|0.121|0.431||A closed hierarchical procedure testing dexpramipexole against placebo at Week 12 was used. (1) 150 mg BID for AEC (2) 75 mg BID for AEC (3) pooled 75 mg and 150 mg BID group for pre-bronchodilator FEV1; and (4) 37.5 mg BID for AEC.|Mixed Models Analysis||0.2283 represents the ratio of the 150 mg BID week 12 ratio to baseline (0.2051), compared to the PBO week 12 ratio to baseline (0.8980). This ratio of 0.2283 is equivalent to a -77.17% change compared to placebo at week 12.|The 150 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.431|0.121|<.0001
70852213|NCT03615040|141192864|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.905|TWO_SIDED|95.0|-0.46|0.52||To compare change from baseline to 48 weeks (pre and post treatment measurements), analysis of covariance (ANCOVA) model with baseline value as a covariate was fitted. Adjusted mean difference with 95% confidence interval and p-value were reported.|ANCOVA|||Total Lung Capacity||0.52|-0.46|0.905
71059356|NCT01512160|141625609|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|90.0|0.4|1.8||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.8|0.4|
71059357|NCT01512160|141625609|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.5|||||TWO_SIDED|90.0|0.7|2.9||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||2.9|0.7|
71059358|NCT01512160|141625610|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|90.0|0.6|1.9||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.9|0.6|
71059359|NCT01512160|141625610|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3|||||TWO_SIDED|90.0|0.7|2.4||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||2.4|0.7|
71059360|NCT01512160|141625610|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|90.0|0.4|1.3||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.3|0.4|
71059361|NCT04205812|141625639|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0042|TWO_SIDED|95.0|0.6|0.93||The p-value was based on a stratified log-rank test at an overall 1-sided 2.5% level of significance, using O'Brien and Fleming boundary to adjust for alpha spending at interim analysis.|Log Rank||A stratified Cox regression with Efron's method for tie handling was used to estimate the hazard ratio.|||0.93|0.60|0.0042
71059362|NCT04205812|141625640|SUPERIORITY||Hazard Ratio (HR)|0.64|||<|0.0001|TWO_SIDED|95.0|0.52|0.79|||Log Rank|The p-value was based on the stratified log-rank test for PFS.|A stratified Cox regression with Efron's method for tie handling was used to estimate the hazard ratio.|||0.79|0.52|<0.0001
71059363|NCT04205812|141625641|SUPERIORITY|||||||0.0012||||||The p-value was calculated at the 1-sided 2.5% level from stratified Cochran-Mantel-Haenszel test.|Cochran-Mantel-Haenszel|||||||0.0012
71059364|NCT06473519|141625656|NON_INFERIORITY|Noninferiority of immune responses induced by MDVRSV preF compared to SDVRSV preF, assessed for RSVA\&B at 1month after vaccination. Null hypotheses(H0): RSVA(H0A)=ln(μMDV)-ln(μSDV)\<=-ln(1.5);RSVB(H0B):ln(μMDV)-ln(μSDV)\<=-ln(1.5), where ln(μMDV)\&ln(μSDV) are means of natural log-transformed antibody concentrations 1month after vaccination for MDV and SDV groups, respectively. Noninferiority=if lower bounds of 2-sided95%CI for GMT ratios (MDV/SDV) were \>0.67(noninferiority margin=1.5)for RSVA\&B.|Geometric mean ratio|0.96|||||TWO_SIDED|95.0|0.84|1.1|||||GMR was calculated as group mean difference of logarithmically transformed antibody levels, back transformed to original units.|RSV A||1.10|0.84|
70852214|NCT03615040|141192864|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.775|TWO_SIDED|95.0|-0.62|0.47||To compare change from baseline to 48 weeks (pre and post treatment measurements), analysis of covariance (ANCOVA) model with baseline value as a covariate was fitted. Adjusted mean difference with 95% confidence interval and p-value were reported.|ANCOVA|||Residual Volume||0.47|-0.62|0.775
70935676|NCT02060487|141372189|SUPERIORITY||Least-squares means difference|20.5||||0.0364|TWO_SIDED|95.0|1.3|39.65|||MMRM|||||39.65|1.30|0.0364
70935677|NCT02060487|141372189|SUPERIORITY||Least-squares means difference|-0.9||||0.9283|TWO_SIDED|95.0|-19.94|18.19|||MMRM|||||18.19|-19.94|0.9283
71026601|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.19||0.184|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Worst pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.6|-0.1|0.1840
71026602|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.1903|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||Least pain: Placebo vs Pregabalin 150 mg BID||0.1|-0.6|0.1903
71026603|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.5787|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||Least pain: Placebo vs DS-5565 15 mg QD||0.2|-0.4|0.5787
71026604|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.5535|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Least pain: Placebo vs DS-5565 15 mg BID||0.2|-0.5|0.5535
71026605|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.18||0.4476|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Least pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.5|-0.2|0.4476
71059365|NCT06473519|141625656|NON_INFERIORITY|Noninferiority of immune responses induced by MDVRSV preF compared to SDVRSV preF, assessed for RSVA\&B at 1 month after vaccination. Null hypotheses(H0):RSVA(H0A)=ln(μMDV)-ln(μSDV)\<=-ln(1.5);RSVB(H0B):ln(μMDV)-ln(μSDV)\<=-ln(1.5), where ln(μMDV)\&ln(μSDV) are means of natural log-transformed antibody concentrations 1 month after vaccination for MDV and SDV groups, respectively. Noninferiority=if lower bounds of 2-sided 95%CI for GMT ratios(MDV/SDV) were \>0.67(noninferiority margin=1.5)for RSVA\&B.|Geometric mean ratio|0.91|||||TWO_SIDED|95.0|0.79|1.06|||||GMR was calculated as group mean difference of logarithmically transformed antibody levels, back transformed to original units.|RSV B||1.06|0.79|
71059366|NCT03713593|141625691|OTHER|Descriptive assessment|Hazard Ratio (HR)|0.834|||||TWO_SIDED|95.0|0.712|0.978|||||Based on Cox model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||0.978|0.712|
71059367|NCT03713593|141625692|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0227|TWO_SIDED|95.0|0.708|0.997|||Log Rank|Onesided p-value based on logrank test stratified by geographic region, portal vein invasion/extrahepatic spread/both AFP status,ECOG status.|Based on Cox model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||0.997|0.708|0.0227
71059368|NCT03713593|141625693|OTHER|Descriptive assessment|Difference in percentage|8.5|||||TWO_SIDED|95.0|2.8|14.2|||||Based on Miettinen \& Nurminen method stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||14.2|2.8|
71059369|NCT03713593|141625696|OTHER|Descriptive assessment|Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.66|0.93|||||Based on Cox model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||0.93|0.66|
71059370|NCT03713593|141625697|OTHER|Descriptive assessment|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.68|0.94|||||Based on Cox model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||0.94|0.68|
71059371|NCT03713593|141625698|OTHER|Descriptive assessment|Difference in percentage|6.7|||||TWO_SIDED|95.0|0.0|13.4|||||Based on Miettinen \& Nurminen method stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||13.4|0.0|
71059372|NCT03713593|141625701|OTHER|Descriptive assessment|Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.61|0.88|||||Based on Cox model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||0.88|0.61|
71059373|NCT04776148|141625707|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by presence of liver metastasis (Yes/No).|Hazard Ratio (HR)|0.69||||0.0003|TWO_SIDED|95.0|0.56|0.85||One-sided p-value based on log-rank test stratified by presence of liver metastasis|Log Rank|||||0.85|0.56|0.0003
71059374|NCT04776148|141625708|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.15||||0.7421|TWO_SIDED|85.0|0.75|1.77||One-sided p-value based on log-rank test.|Log Rank|||||1.77|0.75|0.7421
71059375|NCT04776148|141625709|OTHER||Difference in Percentage vs. SOC|8.7|||<|0.0001|TWO_SIDED|95.0|4.7|13.5|||Chi-squared||Based on Miettinen \& Nurminen method stratified by presence of liver metastasis|||13.5|4.7|<0.0001
71059376|NCT04776148|141625710|OTHER||Difference in Percentage vs. SOC|3.3||||0.2456|TWO_SIDED|95.0|-7.7|14.3|||Chi-squared||Based on Miettinen \& Nurminen method.|||14.3|-7.7|0.2456
71059377|NCT04776148|141625717|OTHER||Difference in least squares means|2.71||||0.1553|TWO_SIDED|95.0|-1.03|6.46||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction and stratification factor presence of liver metastasis (Yes/No).|cLDA model|||||6.46|-1.03|0.1553
70935678|NCT01860079|141372197|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared, Corrected|||Categorical data were analyzed with χ2.Comparisons were also analyzed by χ2 between the early discharge and standard treatment arm for the primary outcomes.||||<0.05
70935679|NCT03292692|141372205|SUPERIORITY||Slope|0.372|||<|0.001|TWO_SIDED|95.0|0.279|0.465|||Regression, Linear|Multi-level regression|Slope of intervention group compared to slope of the control group|||0.465|0.279|<0.001
71026606|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.18||0.4737|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Least pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.5|-0.2|0.4737
71026607|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.0814|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||Average pain: Placebo vs Pregabalin 150 mg BID||0.0|-0.6|0.0814
71026608|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.3069|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Average pain: Placebo vs DS-5565 15 mg QD||0.2|-0.5|0.3069
71026609|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.16||0.3916|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Average pain: Placebo vs DS-5565 15 mg BID||0.2|-0.5|0.3916
71026610|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.16||0.4667|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|||Average pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.4|-0.2|0.4667
70852215|NCT03615040|141192865|SUPERIORITY||Geometric mean ratio|1.01||||0.736|TWO_SIDED|95.0|0.95|1.07||"Outcome was log transformed~Explanatory variables:~treatment arm, number of exacerbations in the 12 months prior to the trial (stratification factor), log BL value, visit time point (categorical) and patient identification (random effect)."|Mixed Models Analysis|||White blood cell count||1.07|0.95|0.736
70935680|NCT03292692|141372206|SUPERIORITY||Slope|0.17|||<|0.001|TWO_SIDED|95.0|0.105|0.235|||Regression, Linear|Multilevel linear modeling|Slope of the intervention group compared to slope of the control group|||0.235|0.105|<0.001
71059378|NCT04776148|141625718|OTHER||Difference in LS means|1.16||||0.4967|TWO_SIDED|95.0|-2.19|4.51||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction and stratification factor presence of liver metastasis (Yes/No).|cLDA model|||||4.51|-2.19|0.4967
71059379|NCT04776148|141625719|OTHER||Difference in LS means|3.36||||0.2271|TWO_SIDED|95.0|-2.1|8.82||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction and stratification factor presence of liver metastasis (Yes/No).|cLDA model|||||8.82|-2.10|0.2271
71059380|NCT04776148|141625720|OTHER||Difference in LS means|-5.46||||0.0264|TWO_SIDED|95.0|-10.27|-0.65||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction and stratification factor presence of liver metastasis (Yes/No).|cLDA model|||||-0.65|-10.27|0.0264
71059381|NCT04776148|141625721|OTHER||Hazard Ratio (HR)|0.91||||0.4338|TWO_SIDED|95.0|0.73|1.14|||Regression, Cox|Two-sided p-value based on log-rank test stratified by presence of liver metastasis (Yes/No).||||1.14|0.73|0.4338
71059382|NCT04776148|141625722|OTHER||Hazard Ratio (HR)|1.1||||0.4316|TWO_SIDED|95.0|0.87|1.38||Two-sided p-value based on log-rank test stratified by presence of liver metastasis (Yes/No).|Regression, Cox|||||1.38|0.87|0.4316
71059383|NCT04776148|141625723|OTHER||Hazard Ratio (HR)|1.06||||0.5587|TWO_SIDED|95.0|0.85|1.32|||Regression, Cox|Two-sided p-value based on log-rank test stratified by presence of liver metastasis (Yes/No).||||1.32|0.85|0.5587
71059384|NCT04776148|141625724|OTHER||Hazard Ratio (HR)|0.95||||0.6794|TWO_SIDED|95.0|0.73|1.23||Two-sided p-value based on log-rank test stratified by presence of liver metastasis (Yes/No).|Regression, Cox|||||1.23|0.73|0.6794
71059385|NCT04776148|141625725|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0379|TWO_SIDED|95.0|0.68|1.02|||Log Rank|One-sided p-value based on log-rank test stratified by presence of liver metastasis (Yes/No).|HR=Lenvatinib + pembrolizumab vs. SOC treatment|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by presence of liver metastasis (Yes/No).||1.02|0.68|0.0379
71059386|NCT04776148|141625726|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.3574|TWO_SIDED|95.0|0.6|1.42|||Log Rank|One-sided p-value based on log-rank test.|HR=Lenvatinib + pembrolizumab vs. SOC treatment|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.||1.42|0.60|0.3574
71059387|NCT03915652|141625759|SUPERIORITY||Mean Difference (Final Values)|-0.93||||0.34|TWO_SIDED|95.0|-2.88|1.02|||t-test, 2 sided|Paired t-test||Waves 1 and 2 were combined and appointment nonadherence during the intervention was compared with the 12 months prior.||1.02|-2.88|0.34
71059388|NCT03915652|141625760|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.34|TWO_SIDED|95.0|-1.08|0.39|||t-test, 2 sided|Paired t-test||Waves 1 and 2 were combined and emergency department visits and hospitalizations during the intervention was compared with the 12 months prior.||0.39|-1.08|0.34
71059389|NCT03915652|141625761|SUPERIORITY||Mean Difference (Final Values)|0.59|||<|0.001|TWO_SIDED|95.0|0.45|0.73|||t-test, 1 sided|One sided t-test of percent of needs remaining from 100%.||Wave 1 and Wave 2 were combined and the quality metric at the end of the 12-month intervention was compared to the metric from the start of the intervention.||0.73|0.45|<0.001
71059390|NCT03915652|141625762|SUPERIORITY||Mean Difference (Final Values)|7.5||||0.51|TWO_SIDED|95.0|-19.8|34.8|||t-test, 2 sided|||||34.8|-19.8|0.51
71059391|NCT03915652|141625763|SUPERIORITY||Mean Difference (Final Values)|0.74||||0.17|TWO_SIDED|95.0|-0.43|1.92|||t-test, 2 sided|Paired t-test||Waves 1 and 2 combined, compared post to pre.||1.92|-0.43|0.17
71059392|NCT03915652|141625764|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.72|TWO_SIDED|95.0|-4.92|6.52|||t-test, 2 sided|Paired t-test||Waves 1 and 2 combined, compared pre/post intervention||6.52|-4.92|0.72
71059393|NCT03915652|141625765|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.5|TWO_SIDED|95.0|-6.22|10.22|||t-test, 2 sided|||Waves 1 and 2 are combined; pre/post survey analysis||10.22|-6.22|0.50
71059394|NCT03915652|141625766|SUPERIORITY||Mean Difference (Final Values)|3.77||||0.01|TWO_SIDED|95.0|1.06|6.47|||t-test, 2 sided|||Waves 1 and 2 combined; pre/post analysis||6.47|1.06|0.01
71059395|NCT03915652|141625767|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.77|TWO_SIDED|95.0|-1.27|0.98|||t-test, 2 sided|Paired t-test||Waves 1 and 2 combined, pre/post test||0.98|-1.27|0.77
71059396|NCT03915652|141625768|SUPERIORITY||Mean Difference (Final Values)|2.14||||0.37|TWO_SIDED|95.0|-3.23|7.52|||t-test, 2 sided|Paired t-test||Waves 1 and 2 combined; pre/post analysis||7.52|-3.23|0.37
71059397|NCT03041311|141625769|SUPERIORITY||||||<|0.0001|ONE_SIDED|95.0||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (for 2 primary and 3 key secondary endpoints) in a strong sense at a 1-sided 0.025 level.|non-parametric ANCOVA|Hochberg-based gatekeeping procedure||Treatment difference was evaluated using a nonparametric analysis of covariance (ANCOVA). The nonparametric ANCOVA included study baseline ANC value as covariate, stratification factors of ECOG performance status (0 to 1 versus 2) and brain metastases (Yes versus No), and treatment as a fixed effect.||||<0.0001
71059398|NCT03041311|141625770|SUPERIORITY||||||<|0.0001||||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (for 2 primary and 3 key secondary endpoints) in a strong sense at a 1-sided 0.025 level.|Modified Poisson|Hochberg-based gatekeeping procedure||The occurrence of SN was a binary variable. Treatment group difference was analyzed using a modified Poisson regression model to account for the variable duration of the Induction Period for each patient. The model included baseline ANC count as a covariate, the stratification factors of ECOG performance status (0 to1 vs. 2) and brain metastases (Yes vs. No), and treatment as a fixed effect. The logarithm transformation of # of Induction cycles was included as an offset variable in the modeling.||||<0.0001
70935681|NCT03292692|141372207|SUPERIORITY||Mean Difference (Final Values)|-2.149|||<|0.001|TWO_SIDED|95.0|-2.974|-1.324|||Regression, Linear|Multilevel linear regression|Multilevel linear modeling, with time modeled as change from pre-post.|||-1.324|-2.974|<0.001
71059399|NCT03041311|141625771|SUPERIORITY|||||||0.0195||||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (for 2 primary and 3 key secondary endpoints) in a strong sense at a 1-sided 0.025 level.|negative binomial regression|Hochberg-based gatekeeping procedure||||||0.0195
71059400|NCT03041311|141625772|SUPERIORITY|||||||0.1335||||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (for 2 primary and 3 key secondary endpoints) in a strong sense at a 1-sided 0.025 level.|Modified Poisson|Hochberg-based gatekeeping procedure||Treatment group difference was analyzed using a modified Poisson regression model. The model included baseline hemoglobin as a covariate, the stratification factors of ECOG performance status (0 to 1 versus 2) and brain metastases (Yes versus No) and treatment as a fixed effect. The logarithm transformation of the number of weeks on treatment was included as an offset variable in the model.||||0.1335
71059401|NCT03041311|141625773|SUPERIORITY|||||||0.0686||||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (for 2 primary and 3 key secondary endpoints) in a strong sense at a 1-sided 0.025 level.|Modified Poisson|Hochberg-based gatekeeping procedure||Treatment group difference was analyzed using a modified Poisson regression model to account for the variable duration of the Induction Period for each patient. The model included baseline absolute neutrophil count as a covariate, the stratification factors of ECOG performance status (0 to 1 versus 2) and brain metastases (Yes versus No), and treatment as a fixed effect. The logarithm transformation of number of Induction cycles was included as an offset variable in the modeling.||||0.0686
71059402|NCT03041311|141625774|SUPERIORITY|For time-to-event variable, the Kaplan-Meier method was used to estimate its within group median value, 25% and 75% percentile values.|Hazard Ratio (HR)|0.99|STANDARD_ERROR_OF_MEAN|0.218||0.9942|TWO_SIDED|95.0|0.64|1.52||The 2-sided p-value was obtained from the stratified log-rank test to account for the stratification factors.|Log Rank|stratified log-rank test|The HR and its 95% CI were calculated using the Cox proportional hazard regression model with treatment and stratification factors of ECOG performance status (0 to 1 versus 2) and presence of brain metastases (Yes versus No).|||1.52|0.64|0.9942
71059403|NCT03071692|141625796|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.92|1.16||||||||1.16|0.92|
71059404|NCT03071692|141625797|SUPERIORITY||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.92|1.2||||||||1.20|0.92|
71059405|NCT03071692|141625798|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.89|1.18||||||||1.18|0.89|
71059406|NCT03071692|141625799|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.93|1.16||||||||1.16|0.93|
71059407|NCT03071692|141625800|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.93|1.13||||||||1.13|0.93|
71059408|NCT03071692|141625801|SUPERIORITY||Event Rate Ration|0.99|||||TWO_SIDED|95.0|0.87|1.13||||||||1.13|0.87|
71059409|NCT03071692|141625802|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.69|1.09||||||||1.09|0.69|
71059410|NCT03071692|141625803|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.95|1.41||||||||1.41|0.95|
71059411|NCT03071692|141625804|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.69|1.19||||||||1.19|0.69|
71059412|NCT03071692|141625805|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.84|1.14||||||||1.14|0.84|
71059413|NCT03071692|141625806|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.83|1.32||||||||1.32|0.83|
71059414|NCT03071692|141625807|SUPERIORITY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.75|1.26||||||TT Variant||1.26|0.75|
71059415|NCT03071692|141625807|SUPERIORITY||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.96|1.47||||||CT Variant||1.47|0.96|
71059416|NCT03071692|141625807|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.69|1.39||||||CC Variant||1.39|0.69|
71059417|NCT03071692|141625808|SUPERIORITY|||||||0.13496|||||||ANCOVA|||||||0.13496
71059418|NCT03071692|141625809|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
71059419|NCT03071692|141625810|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
71059420|NCT03071692|141625811|SUPERIORITY|||||||0.96689|||||||ANCOVA|||||||0.96689
71059421|NCT03071692|141625812|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
71059422|NCT03071692|141625813|SUPERIORITY|||||||0.09178|||||||ANCOVA|||||||0.09178
71059423|NCT03071692|141625814|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
71059424|NCT03071692|141625815|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
71059425|NCT03071692|141625816|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
71059426|NCT03164616|141625845|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.00093|TWO_SIDED|95.0|0.62|0.885||Analysis was performed using a stratified log-rank test adjusting for PD-L1 tumor expression (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using the Breslow approach for handling ties.|Log Rank||The HR and confidence interval (CI) were estimated from a stratified Cox proportional hazards model adjusting for PD-L1 (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using Efron method to control for ties.|D + SoC vs SoC alone. A hazard ratio (HR) \<1 favors D + SoC to be associated with a longer PFS than SoC alone.||0.885|0.620|0.00093
71059427|NCT03164616|141625846|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.07581|TWO_SIDED|95.0|0.724|1.016||Analysis was performed using a stratified log-rank test adjusting for PD-L1 tumor expression (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using the Breslow approach for handling ties.|Log Rank||The HR and CI were estimated from a stratified Cox proportional hazards model adjusting for PD-L1 (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using Efron method to control for ties.|D + SoC vs SoC alone. An HR \<1 favors D + SoC to be associated with a longer OS than SoC alone.||1.016|0.724|0.07581
71059428|NCT03164616|141625847|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.00031|TWO_SIDED|95.0|0.6|0.86||Analysis was performed using a stratified log-rank test adjusting for PD-L1 tumor expression (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using the Breslow approach for handling ties.|Log Rank||The HR and CI were estimated from a stratified Cox proportional hazards model adjusting for PD-L1 (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using Efron method to control for ties.|T + D + SoC vs SoC alone. An HR \<1 favors T + D + SoC to be associated with a longer PFS than SoC alone.||0.860|0.600|0.00031
71026611|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.16||0.3744|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Average pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.5|-0.2|0.3744
71026612|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.2959|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Pain right now: Placebo vs Pregabalin 150 mg BID||0.2|-0.6|0.2959
71026613|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.19||0.9119|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Pain right now: Placebo vs DS-5565 15 mg QD||0.4|-0.4|0.9119
71026614|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.19||0.9399|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Pain right now: Placebo vs DS-5565 15 mg BID||0.4|-0.4|0.9399
71026615|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.19||0.2455|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Pain right now: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.6|-0.2|0.2455
71026616|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.19||0.3311|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Pain right now: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.6|-0.2|0.3311
71026617|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|-0.254|STANDARD_ERROR_OF_MEAN|0.1647||0.1233|TWO_SIDED|95.0|-0.577|0.069|||ANCOVA|||Severity score: Placebo vs Pregabalin 150 mg BID||0.069|-0.577|0.1233
71026618|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|-0.072|STANDARD_ERROR_OF_MEAN|0.1643||0.661|TWO_SIDED|95.0|-0.394|0.25|||ANCOVA|||Severity score: Placebo vs DS-5565 15 mg QD||0.250|-0.394|0.6610
71026619|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|-0.098|STANDARD_ERROR_OF_MEAN|0.1649||0.5514|TWO_SIDED|95.0|-0.422|0.225|||ANCOVA|||Severity score: Placebo vs DS-5565 15 mg BID||0.225|-0.422|0.5514
71026620|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|0.182|STANDARD_ERROR_OF_MEAN|0.1638||0.2673|TWO_SIDED|95.0|-0.14|0.503|||ANCOVA|||Severity score: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.503|-0.140|0.2673
71026621|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|0.156|STANDARD_ERROR_OF_MEAN|0.1644||0.3439|TWO_SIDED|95.0|-0.167|0.478|||ANCOVA|||Severity score: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.478|-0.167|0.3439
71026622|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|2.6|STANDARD_ERROR_OF_MEAN|2.4||0.2708|TWO_SIDED|95.0|-2.1|7.4|||ANCOVA|||Relief (%) by treatment of pain: Placebo vs Pregabalin 150 mg BID||7.4|-2.1|0.2708
71026623|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|1.2|STANDARD_ERROR_OF_MEAN|2.4||0.6285|TWO_SIDED|95.0|-3.5|5.9|||ANCOVA|||Relief (%) by treatment of pain: Placebo vs DS-5565 15 mg QD||5.9|-3.5|0.6285
71026624|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|2.41||0.9177|TWO_SIDED|95.0|-5.0|4.5|||ANCOVA|||Relief (%) by treatment of pain: Placebo vs DS-5565 150 mg BID||4.5|-5.0|0.9177
71059429|NCT03164616|141625848|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.00304|TWO_SIDED|95.0|0.65|0.916||Analysis was performed using a stratified log-rank test adjusting for PD-L1 tumor expression (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using the Breslow approach for handling ties.|Log Rank||The HR and CI were estimated from a stratified Cox proportional hazards model adjusting for PD-L1 (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using Efron method to control for ties.|T + D + SoC vs SoC alone. An HR \<1 favors T + D + SoC to be associated with a longer OS than SoC alone.||0.916|0.650|0.00304
71026625|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|-1.5|STANDARD_ERROR_OF_MEAN|2.38||0.5334|TWO_SIDED|95.0|-6.2|3.2|||ANCOVA|||Relief (%) by treatment of pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||3.2|-6.2|0.5334
71026626|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|-2.9|STANDARD_ERROR_OF_MEAN|2.39||0.2261|TWO_SIDED|95.0|-7.6|1.8|||ANCOVA|||Relief (%) by treatment of pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||1.8|-7.6|0.2261
71059430|NCT03164616|141625849|SUPERIORITY||Odds Ratio (OR)|1.9|||||TWO_SIDED|95.0|1.382|2.619||||||D + SoC vs SoC alone. An odds ratio \>1 favors D + SoC compared to SoC alone. Analysis was performed using logistic regression adjusting for PD-L1 tumor expression (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB), with the CI calculated using a profile likelihood approach.||2.619|1.382|
70935682|NCT03292692|141372208|SUPERIORITY||Mean Difference (Final Values)|-1.144||||0.002|TWO_SIDED|95.0|-1.871|-0.417|||Regression, Linear||Multilevel linear modeling, with time modeled as change from pre to post.|||-0.417|-1.871|0.002
71026627|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|-3.87|STANDARD_ERROR_OF_MEAN|1.758||0.0281|TWO_SIDED|95.0|-7.32|-0.42|||ANCOVA|||Interference: Placebo vs Pregabalin 150 mg BID||-0.42|-7.32|0.0281
71026628|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|-1.42|STANDARD_ERROR_OF_MEAN|1.756||0.419|TWO_SIDED|95.0|-4.87|2.03|||ANCOVA|||Interference: Placebo vs DS-5565 15 mg QD||2.03|-4.87|0.4190
71026629|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|-1.61|STANDARD_ERROR_OF_MEAN|1.763||0.3622|TWO_SIDED|95.0|-5.06|1.85|||ANCOVA|||Interference: Placebo vs DS-5565 15 mg BID||1.85|-5.06|0.3622
71026630|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|2.45|STANDARD_ERROR_OF_MEAN|1.75||0.1623|TWO_SIDED|95.0|-0.99|5.88|||ANCOVA|||Interference: Pregabalin 150 mg BID vs DS-5565 15 mg QD||5.88|-0.99|0.1623
71026631|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|2.26|STANDARD_ERROR_OF_MEAN|1.753||0.1978|TWO_SIDED|95.0|-1.18|5.7|||ANCOVA|||Interference: Pregabalin 150 mg BID vs DS-5565 15 mg BID||5.70|-1.18|0.1978
71026632|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0867|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||General activity: Placebo vs Pregabalin 150 mg BID||0.1|-0.8|0.0867
71026633|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.6993|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||General activity: Placebo vs DS-5565 15 mg QD||0.3|-0.5|0.6993
71026634|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.21||0.8702|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||General activity: Placebo vs DS-5565 15 mg BID||0.4|-0.4|0.8702
71026635|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1826|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||General activity: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.7|-0.1|0.1826
71109414|NCT04046939|141724273|SUPERIORITY||Ratio to PBO of the ratios to baseline|0.3403||||0.0014|TWO_SIDED|95.0|0.177|0.653||A closed hierarchical procedure testing dexpramipexole against placebo at Week 12 was used. (1) 150 mg BID for AEC (2) 75 mg BID for AEC (3) pooled 75 mg and 150 mg BID group for pre-bronchodilator FEV1; and (4) 37.5 mg BID for AEC.|Mixed Models Analysis||0.3403 represents the ratio of the 75 mg BID week 12 ratio to baseline (0.3056), compared to the PBO week 12 ratio to baseline (0.8980). This ratio of 0.3403 is equivalent to a -65.97% change compared to placebo at week 12.|The 75 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.653|0.177|0.0014
71109415|NCT04046939|141724273|SUPERIORITY||Ratio to PBO of the ratios to baseline|0.4489||||0.019|TWO_SIDED|95.0|0.231|0.874||A closed hierarchical statistical testing was used. The previous endpoint in the hierarchy was not statistically significant. Therefore, this endpoint was not formally tested and is not considered statistically significant, despite a p-value \<0.05.|Mixed Models Analysis||0.4489 represents the ratio of the 37.5 mg BID week 12 ratio to baseline (0.4031) compared to the PBO week 12 ratio to baseline (0.8980). This ratio of 0.4489 is equivalent to a -55.11% change compared to placebo at week 12.|The 37.5 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.874|0.231|0.0190
71117633|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
71026636|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1206|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||General activity: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|-0.1|0.1206
71026637|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0211|TWO_SIDED|95.0|-0.9|-0.1|||ANCOVA|||Mood: Placebo vs Pregabalin 150 mg BID||-0.1|-0.9|0.0211
71026638|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.4963|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||Mood: Placebo vs DS-5565 15 mg QD||0.3|-0.6|0.4963
71026639|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.3031|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Mood: Placebo vs DS-5565 15 mg BID||0.2|-0.6|0.3031
71026640|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1019|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Mood: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|-0.1|0.1019
71026641|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.201|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Mood: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|-0.1|0.2010
71026642|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0331|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||Walking ability: Placebo vs Pregabalin 150 mg BID||-0.0|-0.9|0.0331
71026643|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.7478|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Walking ability: Placebo vs DS-5565 15 mg QD||0.3|-0.5|0.7478
71026644|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.694|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Walking ability: Placebo vs DS-5565 15 mg BID||0.3|-0.5|0.6940
71026645|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.21||0.069|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||Walking ability: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|-0.0|0.0690
71026646|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0816|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||Walking ability: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.8|-0.0|0.0816
71026647|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1174|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Normal work: Placebo vs Pregabalin 150 mg BID||0.1|-0.7|0.1174
71026648|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.21||0.925|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Normal work: Placebo vs DS-5565 15 mg QD||0.4|-0.4|0.9250
71026649|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.21||0.8555|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Normal work: Placebo vs DS-5565 15 mg BID||0.4|-0.4|0.8555
71026650|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.0956|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Normal work: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.7|-0.1|0.0956
71026651|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1659|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Normal work: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|-0.1|0.1659
71026652|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0468|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||Relations with other people: Placebo vs Pregabalin 150 mg BID||-0.0|-0.8|0.0468
71026653|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1083|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Relations with other people: Placebo vs DS-5565 15 mg QD||0.1|-0.7|0.1083
71026654|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0505|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||Relations with other people: Placebo vs DS-5565 15 mg BID||0.0|-0.8|0.0505
71026655|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.21||0.6993|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Relations with other people: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.5|-0.3|0.6993
71026656|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.21||0.9781|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Relations with other people: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.4|-0.4|0.9781
71026657|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|-0.6|STANDARD_ERROR_OF_MEAN|0.23||0.0154|TWO_SIDED|95.0|-1.0|-0.1|||ANCOVA|||Sleep: Placebo vs Pregabalin 150 mg BID||-0.1|-1.0|0.0154
71026658|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.23||0.0731|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||Sleep: Placebo vs DS-5565 15 mg QD||0.0|-0.9|0.0731
71026659|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.23||0.0259|TWO_SIDED|95.0|-1.0|-0.1|||ANCOVA|||Sleep: Placebo vs DS-5565 15 mg BID||-0.1|-1.0|0.0259
71026660|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.23||0.5243|TWO_SIDED|95.0|-0.3|0.6|||ANCOVA|||Sleep: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.6|-0.3|0.5243
71059431|NCT03164616|141625849|SUPERIORITY||Odds Ratio (OR)|1.72|||||TWO_SIDED|95.0|1.26|2.367||||||T + D + SoC vs SoC alone. An odds ratio \>1 favors T + D + SoC compared to SoC alone. Analysis was performed using logistic regression adjusting for PD-L1 tumor expression (TC ≥50% vs TC \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB), with the CI calculated using a profile likelihood approach.||2.367|1.260|
71059432|NCT03164616|141625852|SUPERIORITY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.666|0.928|||||The HR and CI were estimated from a stratified Cox proportional hazards model adjusting for PD-L1 (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using Efron method to control for ties.|D + SoC vs SoC alone. An HR \<1 favors D + SoC to be associated with a longer PFS2 than SoC alone.||0.928|0.666|
71059433|NCT03164616|141625852|SUPERIORITY||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.632|0.883|||||The HR and CI were estimated from a stratified Cox proportional hazards model adjusting for PD-L1 (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using Efron method to control for ties.|T + D + SoC vs SoC alone. An HR \<1 favors T + D + SoC to be associated with a longer PFS2 than SoC alone.||0.883|0.632|
71059434|NCT04917861|141625893|OTHER||Geometric Mean Ratio (GMR)|7.002|||||TWO_SIDED|95.0|5.451|8.992|||||GMR (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||8.992|5.451|
71059435|NCT04917861|141625893|OTHER||GMR|7.123|||||TWO_SIDED|95.0|5.467|9.279|||||GMR (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||9.279|5.467|
71117634|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
70941723|NCT04748445|141383935|OTHER||Slope|0.0007281|STANDARD_ERROR_OF_MEAN|5.677||0.202|TWO_SIDED|90.0|-0.0002126|0.001669|||Mixed Models Analysis|||EE\_MFCC 1st order delta 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001669|-0.0002126|0.2020
71026661|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.23||0.8488|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||Sleep: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.5|-0.4|0.8488
71026662|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.22||0.2746|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||Enjoyment of life: Placebo vs Pregabalin 150 mg BID||0.2|-0.7|0.2746
71026663|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.22||0.9349|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Enjoyment of life: Placebo vs DS-5565 15 mg QD||0.4|-0.4|0.9349
71026664|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.22||0.5164|TWO_SIDED|95.0|-0.3|0.6|||ANCOVA|||Enjoyment of life: Placebo vs DS-5565 15 mg BID||0.6|-0.3|0.5164
71026665|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.2382|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Enjoyment of life: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.7|-0.2|0.2382
71026666|NCT02146430|141560704|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0807|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||Enjoyment of life: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.8|-0.0|0.0807
71026667|NCT02146430|141560705|SUPERIORITY||Difference in least squares means|-0.045|STANDARD_ERROR_OF_MEAN|0.0237||0.0601|TWO_SIDED|95.0|-0.091|0.002|||ANCOVA|||||0.002|-0.091|0.0601
71026668|NCT02146430|141560705|SUPERIORITY||Difference in least squares means|-0.005|STANDARD_ERROR_OF_MEAN|0.0237||0.8299|TWO_SIDED|95.0|-0.052|0.041|||ANCOVA|||||0.041|-0.052|0.8299
71026669|NCT02146430|141560705|SUPERIORITY||Difference in least squares means|-0.05|STANDARD_ERROR_OF_MEAN|0.0237||0.0347|TWO_SIDED|95.0|-0.096|0.004|||ANCOVA|||||0.004|-0.096|0.0347
71059436|NCT04917861|141625893|OTHER||GMR|2.674|||||TWO_SIDED|95.0|1.961|3.646|||||GMR (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for all participants|||3.646|1.961|
71026670|NCT02146430|141560705|SUPERIORITY||Difference in least squares means|0.04|STANDARD_ERROR_OF_MEAN|0.0237||0.0951|TWO_SIDED|95.0|-0.007|0.086|||ANCOVA|||||0.086|-0.007|0.0951
71026671|NCT02146430|141560705|SUPERIORITY||Difference in least squares means|-0.005|STANDARD_ERROR_OF_MEAN|0.0237||0.8199|TWO_SIDED|95.0|-0.052|0.041|||ANCOVA|||||0.041|-0.052|0.8199
71026672|NCT01893905|141560706|SUPERIORITY_OR_OTHER||||||<|0.0307|||||||Pocock approach|||||||<0.0307
71026673|NCT02396381|141560792|OTHER||LS Mean Difference|3.09|||<|0.001|TWO_SIDED|96.875|1.1|5.09|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach||"The analysis will test if the mean level of HDL-C for THS-use is greater than for CC-use. The following hypothesis will be evaluated:~H0: XTHS - XCC ≤ 0.0~HA: XTHS - XCC \> 0.0~where XTHS and XCC are the adjusted means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||5.09|1.10|<0.001
71026674|NCT02396381|141560793|SUPERIORITY||LS Mean Difference|-0.42||||0.001|TWO_SIDED|96.875|-0.717|-0.123|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach||"The analysis will test if the mean level of WBC for THS-use is lower than for CC-use. The following hypothesis will be evaluated:~H0: XTHS - XCC ≥ 0.0~HA: XTHS - XCC \< 0.0~where XTHS and XCC are the adjusted means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||-0.123|-0.717|0.001
71059437|NCT04917861|141625893|OTHER||GMR|7.208|||||TWO_SIDED|95.0|5.428|9.571|||||GMR (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-seronegative participants|||9.571|5.428|
71059438|NCT04917861|141625893|OTHER||GMR|7.979|||||TWO_SIDED|95.0|6.106|10.425|||||GMR (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-seronegative participants|||10.425|6.106|
71059439|NCT04917861|141625893|OTHER||GMR|1.516|||||TWO_SIDED|95.0|1.229|1.869|||||GMR (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-seronegative participants|||1.869|1.229|
71059440|NCT04917861|141625893|OTHER||GMR|6.785|||||TWO_SIDED|95.0|4.562|10.092|||||GMR (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-seropositive participants|||10.092|4.562|
71026675|NCT02396381|141560794|SUPERIORITY||LS Mean Difference|1.28||||0.008|TWO_SIDED|96.875|0.145|2.42|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach||"The analysis will test if the mean level of FEV1 for THS-use is greater than for CC-use. The following hypothesis will be evaluated:~H0: XTHS - XCC ≤ 0.0~HA: XTHS - XCC \> 0.0~where XTHS and XCC are the adjusted means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||2.42|0.145|0.008
71026676|NCT02396381|141560795|SUPERIORITY||% Reduction|2.86||||0.03|TWO_SIDED|96.875|-0.426|6.04|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach|Derived as 1 - LS Mean Ratio (THS / CC)|"The analysis of sICAM-1 will test if the mean level of this clinical risk endpoint for THS-use is lower relative to CC-use. The following hypothesis will be evaluated:~H0: XTHS / XCC ≥ 1.0~HA: XTHS / XCC \< 1.0~where XTHS and XCC are the adjusted geometrical means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||6.04|-0.426|0.030
71026677|NCT02396381|141560796|SUPERIORITY||% Reduction|4.74||||0.193|TWO_SIDED|96.875|-7.5|15.6|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach|Derived as 1 - LS Mean Ratio (THS / CC)|"The analysis of 11-DTX-B2 will test if the mean level of this clinical risk endpoint for THS-use is lower relative to CC-use. The following hypothesis will be evaluated:~H0: XTHS / XCC ≥ 1.0~HA: XTHS / XCC \< 1.0~where XTHS and XCC are the adjusted geometrical means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||15.6|-7.5|0.193
71026678|NCT02396381|141560797|SUPERIORITY||% Reduction|6.8||||0.018|TWO_SIDED|96.875|-0.216|13.3|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach|Derived as 1 - LS Mean Ratio (THS / CC)|"The analysis of 8-epi-PGF2α will test if the mean level of this clinical risk endpoint for THS-use is lower relative to CC-use. The following hypothesis will be evaluated:~H0: XTHS / XCC ≥ 1.0~HA: XTHS / XCC \< 1.0~where XTHS and XCC are the adjusted geometrical means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||13.3|-0.216|0.018
71026679|NCT02396381|141560798|SUPERIORITY||% Reduction|43.5|||<|0.001|TWO_SIDED|96.875|33.7|51.9|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach|Derived as 1 - LS Mean Ratio (THS / CC)|"The analysis of Total NNAL will test if the mean level of this clinical risk endpoint for THS-use is lower relative to CC-use. The following hypothesis will be evaluated:~H0: XTHS / XCC ≥ 1.0~HA: XTHS / XCC \< 1.0~where XTHS and XCC are the adjusted geometrical means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||51.9|33.7|<0.001
71026680|NCT02396381|141560799|SUPERIORITY||% Reduction|32.2|||<|0.001|TWO_SIDED|96.875|24.5|39.0|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach|Derived as 1 - LS Mean Ratio (THS / CC)|"The analysis will test if the mean level of COHb for THS-use is lower relative to CC-use. The following hypothesis will be evaluated:~H0: XTHS / XCC ≥ 1.0~HA: XTHS / XCC \< 1.0~where XTHS and XCC are the adjusted geometrical means of THS-use and CC-use. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||39|24.5|<0.001
71026681|NCT03197064|141560800|OTHER|||||||0.35|||||||t-test, 2 sided|||Difference in left upper extremity amplitude between baseline (pre-dose) and 30 minutes post-dose||||0.35
71026682|NCT03197064|141560800|OTHER|||||||0.47|||||||t-test, 2 sided|||Difference in left upper extremity amplitude between baseline (pre-dose) and 60 minutes post-dose||||0.47
71026683|NCT03197064|141560800|OTHER|||||||0.066|||||||t-test, 2 sided|||Difference in left upper extremity amplitude between baseline (pre-dose) and 90 minutes post-dose||||0.066
71026684|NCT03197064|141560801|OTHER|||||||0.72|||||||t-test, 2 sided|||Difference in right upper extremity amplitude between baseline (pre-dose) and 30 minutes post-dose||||0.72
71026685|NCT03197064|141560801|OTHER|||||||0.72|||||||t-test, 2 sided|||Difference in right upper extremity amplitude between baseline (pre-dose) and 60 minutes post-dose||||0.72
71026686|NCT03197064|141560801|OTHER|||||||0.78|||||||t-test, 2 sided|||Difference in right upper extremity amplitude between baseline (pre-dose) and 90 minutes post-dose||||0.78
71026687|NCT03197064|141560802|OTHER|||||||0.93|||||||t-test, 2 sided|||Difference in left lower extremity amplitude between baseline (pre-dose) and 30 minutes post-dose||||0.93
71026688|NCT03197064|141560802|OTHER|||||||0.39|||||||t-test, 2 sided|||Difference in left lower extremity amplitude between baseline (pre-dose) and 60 minutes post-dose||||0.39
71026689|NCT03197064|141560802|OTHER|||||||0.08|||||||t-test, 2 sided|||Difference in left lower extremity amplitude between baseline (pre-dose) and 90 minutes post-dose||||0.08
71026690|NCT03197064|141560803|OTHER|||||||0.42|||||||t-test, 2 sided|||Difference in right lower extremity amplitude between baseline (pre-dose) and 30 minutes post-dose||||0.42
71026691|NCT03197064|141560803|OTHER|||||||0.37|||||||t-test, 2 sided|||Difference in right lower extremity amplitude between baseline (pre-dose) and 60 minutes post-dose||||0.37
71026692|NCT03197064|141560803|OTHER|||||||0.49|||||||t-test, 2 sided|||Difference in right lower extremity amplitude between baseline (pre-dose) and 90 minutes post-dose||||0.49
71026693|NCT03197064|141560804|OTHER|||||||0.386|||||||t-test, 2 sided|||Difference in left upper extremity amplitude between baseline (pre-dose) and 30 minutes post-dose||||0.386
71026694|NCT03197064|141560804|OTHER|||||||0.388|||||||t-test, 2 sided|||Difference in left upper extremity amplitude between baseline (pre-dose) and 60 minutes post-dose||||0.388
71026695|NCT03197064|141560804|OTHER|||||||0.247|||||||t-test, 2 sided|||Difference in left upper extremity amplitude between baseline (pre-dose) and 90 minutes post-dose||||0.247
71026696|NCT01884025|141560823|SUPERIORITY_OR_OTHER|||||||0.59|||||||t-test, 2 sided|t-Value: 0.55||Change in total BADS score.||||0.59
70935683|NCT03055988|141372244|SUPERIORITY||Adjusted mean difference|-0.537|STANDARD_ERROR_OF_MEAN|1.12||0.6331|TWO_SIDED|95.0|-2.779|1.705|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|Mixed model repeated measures (MMRM) model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation. H0: Mean change from baseline in LVEDVI for (Tiotropium + Olodaterol) = Mean change from baseline in LVEDVI for (Fluticasone propionate + Salmeterol)||1.705|-2.779|0.6331
70935684|NCT03055988|141372245|SUPERIORITY||Adjusted mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.036||0.9817|TWO_SIDED|95.0|-0.072|0.074|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||0.074|-0.072|0.9817
70935685|NCT03055988|141372246|SUPERIORITY||Adjusted mean difference|1.28|STANDARD_ERROR_OF_MEAN|1.995||0.5238|TWO_SIDED|95.0|-2.719|5.279|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||5.279|-2.719|0.5238
70935686|NCT03055988|141372247|SUPERIORITY||Adjusted mean difference|2.069|STANDARD_ERROR_OF_MEAN|1.853||0.2687|TWO_SIDED|95.0|-1.64|5.779|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||5.779|-1.640|0.2687
70935687|NCT03055988|141372248|SUPERIORITY||Adjusted mean difference|0.409|STANDARD_ERROR_OF_MEAN|1.335||0.7604|TWO_SIDED|95.0|-2.264|3.082|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||3.082|-2.264|0.7604
70935688|NCT03055988|141372249|SUPERIORITY||Adjusted mean difference|-0.32|STANDARD_ERROR_OF_MEAN|1.509||0.833|TWO_SIDED|95.0|-3.341|2.702|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||2.702|-3.341|0.8330
70935689|NCT03055988|141372250|SUPERIORITY||Adjusted mean difference|-7.957|STANDARD_ERROR_OF_MEAN|2.452||0.0019|TWO_SIDED|95.0|-12.865|-3.05|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||-3.050|-12.865|0.0019
70935690|NCT03055988|141372251|SUPERIORITY||Adjusted mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001|TWO_SIDED|95.0|0.121|0.24|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||0.240|0.121|<0.0001
71026697|NCT01884025|141560823|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|t Value: 0.03||Change in Activation Subscale||||0.98
71026698|NCT01884025|141560823|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|"DF: 18~1 Value: -0.04"||Change in Avoidance/Rumination Subscale||||0.96
71059441|NCT04917861|141625893|OTHER||GMR|6.319|||||TWO_SIDED|95.0|4.03|9.909|||||GMR (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-seropositive participants|||9.909|4.030|
71059442|NCT04917861|141625893|OTHER||GMR|7.028|||||TWO_SIDED|95.0|4.056|12.18|||||GMR (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-seropositive participants|||12.180|4.056|
70852216|NCT03615040|141192865|SUPERIORITY||Geometric mean ratio|0.59|||<|0.001|TWO_SIDED|95.0|0.51|0.69||"Outcome was log transformed~Explanatory variables:~treatment arm, number of exacerbations in the 12 months prior to the trial (stratification factor), log BL value, visit time point (categorical) and patient identification (random effect)."|Mixed Models Analysis|||Eosinophil Count||0.69|0.51|<0.001
70935691|NCT03055988|141372252|SUPERIORITY||Adjusted mean difference|0.286|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001|TWO_SIDED|95.0|0.171|0.4|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||0.400|0.171|<0.0001
71026699|NCT01884025|141560823|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|t Value: 1.31||Change in Work/School Impairment Subscale||||0.21
71026700|NCT01884025|141560823|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|t Value: 0.99||Change in Social Impairment Subscale||||0.34
71026701|NCT01884025|141560824|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|t Value: 0.33||||||0.75
71026702|NCT01884025|141560825|SUPERIORITY_OR_OTHER|||||||0.72|||||||t-test, 2 sided|t Value: -0.36||Change in overall physical activity frequency were compared between the two groups.||||0.72
71026703|NCT01884025|141560825|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|t Value: -0.39||Change in moderate physical activity frequency between the two groups.||||0.70
71059443|NCT04917861|141625894|OTHER||GMR|5.312|||||TWO_SIDED|95.0|4.149|6.802|||||GMR (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||6.802|4.149|
71059444|NCT04917861|141625894|OTHER||GMR|5.346|||||TWO_SIDED|95.0|4.128|6.922|||||GMR (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||6.922|4.128|
71059445|NCT04917861|141625894|OTHER||GMR|2.325|||||TWO_SIDED|95.0|1.721|3.14|||||GMR (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for all participants|||3.140|1.721|
70935692|NCT01736475|141372256|SUPERIORITY_OR_OTHER_LEGACY||Ratio of means|0.1|||<|0.0001|TWO_SIDED|95.0|0.06|0.19|||Regression, Negative binomial|||Ratio Annualized Bleeding Rate (ABR) Prophylaxis/On-demand: Prophylaxis treatment w ill be considered to be successful if the upper limit of the 95% CI for the ratio between treatment regimen does not exceed 0.5 (corresponding to a 50% reduction of the mean ABR compared to the on-demand treatment). H01: μ1 ≥0.5\*μ2 Ha1: μ1\<0.5\*μ2 w here μ1 and μ2 are the mean ABRs in on prophylaxis and on-demand, respectively||0.19|0.06|<0.0001
70935693|NCT02713594|141372351|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-7.86|||<|0.0001|TWO_SIDED|95.0|-11.28|-4.5|||Abstinence Risk Difference|||||-4.5|-11.28|<.0001
70935694|NCT02713594|141372352|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|Chi-square test value = 196.1, with 5 degrees of freedom.||||||<.0001
70935695|NCT03928743|141372396|SUPERIORITY||Odds Ratio (OR)|2.88|||<|0.001|TWO_SIDED|95.0|1.71|4.87|||Regression, Logistic|||||4.87|1.71|<0.001
70935696|NCT03928743|141372397|SUPERIORITY||Odds Ratio (OR)|2.8|||<|0.001|TWO_SIDED|95.0|1.59|4.93|||Regression, Logistic|||||4.93|1.59|<0.001
71026704|NCT01884025|141560826|SUPERIORITY|||||||0.45|ONE_SIDED|95.0|||||t-test, 2 sided|t Value: 0.77||Change in the physical health scale of the RAND 12 were compared.||||0.45
71059446|NCT04917861|141625894|OTHER||GMR|4.221|||||TWO_SIDED|95.0|3.322|5.363|||||GMR (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||5.363|3.322|
71026705|NCT01884025|141560826|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|t Value: 0.76||Change in the mental health scale of the RAND 12 were compared.||||0.45
71026706|NCT01884025|141560827|SUPERIORITY_OR_OTHER|||||||0.72|||||||t-test, 2 sided|t Value: -0.36||||||0.72
71026707|NCT01884025|141560828|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|t Value: 0.15||||||0.88
71026708|NCT01884025|141560829|SUPERIORITY|||||||0.08|ONE_SIDED|95.0|||||t-test, 2 sided|t Value: 1.83||||||.08
71059447|NCT04917861|141625894|OTHER||GMR|5.3|||||TWO_SIDED|95.0|4.243|6.62|||||GMR (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||6.620|4.243|
71059448|NCT04917861|141625894|OTHER||GMR|1.206|||||TWO_SIDED|95.0|1.033|1.407|||||GMR (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||1.407|1.033|
70935697|NCT03928743|141372398|SUPERIORITY||Odds Ratio (OR)|2.66|||<|0.001|TWO_SIDED|95.0|1.65|4.28|||Regression, Logistic|||||4.28|1.65|<0.001
70935698|NCT03928743|141372399|SUPERIORITY||LS Mean difference|-1.04|||<|0.001|TWO_SIDED|95.0|-1.48|-0.59|||Regression, Logistic|||||-0.59|-1.48|<0.001
70935699|NCT03928743|141372400|SUPERIORITY||Odds Ratio (OR)|4.26|||<|0.001|TWO_SIDED|95.0|1.93|9.39|||Regression, Logistic|||||9.39|1.93|<0.001
70935700|NCT03928743|141372401|SUPERIORITY||Odds Ratio (OR)|6.47|||<|0.001|TWO_SIDED|95.0|2.67|15.65|||Regression, Logistic|||||15.65|2.67|<0.001
70935701|NCT03928743|141372402|SUPERIORITY||Odds Ratio (OR)|4.65|||<|0.001|TWO_SIDED|4.65|2.51|7.57|||Regression, Logistic|||||7.57|2.51|<0.001
70935702|NCT03928743|141372403|SUPERIORITY||LS Mean difference|-1.05|||<|0.001|TWO_SIDED|95.0|-1.48|-0.63|||Regression, Logistic|||||-0.63|-1.48|<0.001
70935703|NCT03928743|141372404|SUPERIORITY||LS Mean difference|-1.48|||<|0.001|TWO_SIDED|95.0|-2.0|-0.96|||Regression, Logistic|||||-0.96|-2.00|<0.001
70935704|NCT03928743|141372405|SUPERIORITY||LS Mean difference|-1.52|||<|0.001|TWO_SIDED|95.0|-2.36|-0.68|||Regression, Logistic|||||-0.68|-2.36|<0.001
70935705|NCT03928743|141372406|SUPERIORITY||LS Mean difference|3.38|||<|0.001|TWO_SIDED|95.0|1.67|5.09|||Regression, Logistic|||||5.09|1.67|<0.001
70935706|NCT03928743|141372407|SUPERIORITY||LS Mean difference|-0.28||||0.006|TWO_SIDED|95.0|-0.47|-0.08|||Regression, Logistic|||||-0.08|-0.47|0.006
70935707|NCT03928743|141372408|SUPERIORITY||LS Mean difference|-1.08||||0.003|TWO_SIDED|95.0|-1.79|-0.38|||Regression, Logistic|||||-0.38|-1.79|0.003
70935708|NCT03928743|141372409|SUPERIORITY||Odds Ratio (OR)|2.47||||0.006|TWO_SIDED|95.0|1.3|4.68|||Regression, Logistic|||||4.68|1.30|0.006
70935709|NCT00308308|141372440|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was set to meet regulatory requirement of 250 subjects per arm with 52-week data, resulting in \> 90% power for a non-inferiority test of the difference in 12-month change of HbA1c scores between treatment groups with non-inferiority margin of 0.4%, standard deviation of 1.2 and 1-sided alpha of 0.025. Allowing for a 15% dropout rate, 589 subjects were randomized.|Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.082|||TWO_SIDED|95.0|0.08|0.4|||ANCOVA|||||0.40|0.08|
70935710|NCT00308308|141372441|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001||95.0|-2.7|-1.0|||ANCOVA|||ANCOVA model with terms of pooled site and treatment as fixed effects and baseline weight as covariate||-1.0|-2.7|<0.0001
70935711|NCT00308308|141372442|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.9|STANDARD_ERROR_OF_MEAN|7.41||0.0052|TWO_SIDED|95.0|-35.4|-6.3|||ANCOVA|||||-6.3|-35.4|0.0052
70935712|NCT00308308|141372443|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.941||||0.8311|TWO_SIDED|95.0|0.536|1.652|||Regression, Logistic|||logistic regression analysis with the terms of treatment and baseline HbA1c in the model||1.652|0.536|0.8311
70935713|NCT00308308|141372444|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.488||||0.0124|TWO_SIDED|95.0|0.278|0.856|||Regression, Logistic||Model: Treatment + Site|||0.856|0.278|0.0124
70935714|NCT00308308|141372445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.825||||0.2786|TWO_SIDED|95.0|0.582|1.169|||Regression, Logistic||Model: Treatment + Site|||1.169|0.582|0.2786
70935715|NCT00308308|141372446|SUPERIORITY_OR_OTHER|||||||0.1193|||||||Generalized Estimation Equation|"* Based on Poisson distribution~* Model: Treatment + Time Period"||||||0.1193
70935716|NCT00308308|141372447|SUPERIORITY_OR_OTHER|||||||0.2131|||||||Generalized Estimating Equation|"* Based on Poisson distribution~* Model: Treatment + Time Period"||||||0.2131
71026709|NCT01884025|141560830|SUPERIORITY|||||||0.16||||||Chi Squared 1.98|Chi-squared|||||||.16
71026710|NCT01884025|141560831|SUPERIORITY|||||||0.85||||||t value: .19|t-test, 2 sided|||||||.85
71059449|NCT04917861|141625894|OTHER||GMR|6.493|||||TWO_SIDED|95.0|4.358|9.674|||||GMR (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||9.674|4.358|
71059450|NCT04917861|141625894|OTHER||GMR|5.452|||||TWO_SIDED|95.0|3.43|8.665|||||GMR (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||8.665|3.430|
71059451|NCT04917861|141625894|OTHER||GMR|6.804|||||TWO_SIDED|95.0|3.928|11.784|||||GMR (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||11.784|3.928|
70935717|NCT01686152|141372448|EQUIVALENCE|The test product was determined to be bioequivalent to the reference product if the 90% confidence interval was within -0.20 to 0.20.|Mean Difference (Final Values)|0.05|||||TWO_SIDED|90.0|-0.0663|0.0913||||||||0.0913|-0.0663|
71109416|NCT04046939|141724274|SUPERIORITY||Mean Difference (Final Values)|0.0814||||0.4154|TWO_SIDED|95.0|-0.116|0.279||A closed hierarchical procedure testing dexpramipexole against placebo at Week 12 was used. (1) 150 mg BID for AEC (2) 75 mg BID for AEC (3) pooled 75 mg and 150 mg BID group for pre-bronchodilator FEV1; and (4) 37.5 mg BID for AEC.|Mixed Models Analysis||Estimate is the difference of the pooled 75 mg and 150 mg BID group from placebo in change in pre-bronchodilator FEV1 in liters from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement in lung function.|The combined 75 mg and 150 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.279|-0.116|0.4154
71109417|NCT04046939|141724274|SUPERIORITY||Mean Difference (Final Values)|0.177||||0.1174|TWO_SIDED|95.0|-0.0456|0.4||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|Mixed Models Analysis||Estimate is the difference of the 150 mg BID group from the placebo group in the change in pre-bronchodilator FEV1 in liters from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement in lung function.|The 150 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.400|-0.0456|0.1174
71109418|NCT04046939|141724274|SUPERIORITY||Mean Difference (Final Values)|-0.0143||||0.8998|TWO_SIDED|95.0|-0.24|0.211||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|Mixed Models Analysis||Estimate is the difference of the 75 mg BID group from the placebo group in the change in pre-bronchodilator FEV1 in liters from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement in lung function.|The 75 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.211|-0.240|0.8998
71109419|NCT04046939|141724274|SUPERIORITY||Mean Difference (Final Values)|0.138||||0.2425|TWO_SIDED|95.0|-0.095|0.37||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|Mixed Models Analysis||Estimate is the difference of the 37.5 mg BID group from the placebo group in the change in pre-bronchodilator FEV1 in liters from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement in lung function.|The 37.5 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.370|-0.0950|0.2425
71109420|NCT04046939|141724275|SUPERIORITY||Mean Difference (Final Values)|-0.264||||0.3059|TWO_SIDED|95.0|-0.772|0.245||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|Mixed Models Analysis||Estimate is the difference of the 150 mg BID dexpramipexole group compared to the placebo group in change in ACQ-6 score from Baseline to Week 12 (end of primary treatment period). A negative value indicates improvement of asthma symptoms.|The 150 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.245|-0.772|0.3059
71109421|NCT04046939|141724275|SUPERIORITY||Mean Difference (Final Values)|-0.0457||||0.8642|TWO_SIDED|95.0|-0.575|0.484||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|Mixed Models Analysis||Estimate is the difference of the 75 mg BID dexpramipexole group compared to the placebo group in change in ACQ-6 score from Baseline to Week 12 (end of primary treatment period). A negative value indicates improvement of asthma symptoms.|The 75 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.484|-0.575|0.8642
71109422|NCT04046939|141724275|SUPERIORITY||Mean Difference (Final Values)|-0.0276||||0.9182|TWO_SIDED|95.0|-0.56|0.505||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|Mixed Models Analysis||Estimate is the difference of the 37.5 mg BID dexpramipexole group compared to the placebo group in change in ACQ-6 score from Baseline to Week 12 (end of primary treatment period). A negative value indicates improvement of asthma symptoms.|The 37.5 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.505|-0.560|0.9182
71059452|NCT04917861|141625895|OTHER||percentage difference|76.69|||||TWO_SIDED|95.0|69.1|82.68|||||Percentage Difference (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||82.68|69.10|
71059453|NCT04917861|141625895|OTHER||percentage difference|77.8|||||TWO_SIDED|95.0|70.29|83.67|||||Percentage Difference (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||83.67|70.29|
71059454|NCT04917861|141625895|OTHER||percentage difference|35.58|||||TWO_SIDED|95.0|27.47|43.74|||||Percentage Difference (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for all participants|||43.74|27.47|
70935718|NCT01802333|141372449|OTHER|||||||0.84|||||||Regression, Cox|Adjusted for: Age (\< 40 vs. \>= 40) and Onset of AML (de novo vs. treatment related and/or AML arising from antecedent hematologic disease)||Arm I was compared with Arm III using a two-sided test of the null hypothesis (HR=1) at the 0.045 level.||||0.84
71059455|NCT04917861|141625895|OTHER||percentage difference|86.11|||||TWO_SIDED|95.0|76.25|92.29|||||Percentage Difference (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||92.29|76.25|
71059456|NCT04917861|141625895|OTHER||percentage difference|87.65|||||TWO_SIDED|95.0|78.71|93.17|||||Percentage Difference (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||93.17|78.71|
71059457|NCT04917861|141625895|OTHER||percentage difference|20.43|||||TWO_SIDED|95.0|13.47|29.75|||||Percentage Difference (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||29.75|13.47|
71026711|NCT01884025|141560832|SUPERIORITY|||||||0.6||||||t value: .54|t-test, 2 sided|||||||.60
71026712|NCT01884025|141560833|SUPERIORITY|||||||0.26||||||t value: -1.17|t-test, 2 sided|||||||.26
71026713|NCT01884025|141560834|SUPERIORITY|||||||0.08||||||t value: 1.85|t-test, 2 sided|||||||.08
71109423|NCT04046939|141724276|SUPERIORITY||Mean Difference (Final Values)|0.181||||0.0716|TWO_SIDED|95.0|-0.0163|0.378||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|ANCOVA||Estimate the difference of the 150 mg BID Dexpramipexole group from placebo in change in post-bronchodilator FEV1 from Baseline to Week 12 (end of primary treatment period) in liters. A positive value indicates improvement in lung function.|An ANCOVA analysis was performed comparing the 150 mg BID dexpramipexole group to placebo.||0.378|-0.0163|0.0716
70852217|NCT03615040|141192865|SUPERIORITY||Geometric mean ratio|1.02||||0.678|TWO_SIDED|95.0|0.93|1.13||"Outcome was log transformed~Explanatory variables:~treatment arm, number of exacerbations in the 12 months prior to the trial (stratification factor), log BL value, visit time point (categorical) and patient identification (random effect)."|Mixed Models Analysis|||Neutrophil Count||1.13|0.93|0.678
70852218|NCT03615040|141192866|SUPERIORITY||Geometric mean ratio|0.25|||<|0.001|TWO_SIDED|95.0|0.19|0.33||A mixed effect linear model of the log outcome with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and log baseline score as fixed effects.|Mixed Models Analysis|||Eosinophil count||0.33|0.19|<0.001
71026714|NCT02059993|141560839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.0|||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||The sample size was calculated to assess a minimum reduction of 5 ± 5 mm Hg in systolic BPafter CPAP treatment, assuming an alpha error of 5% and a statistical power of 80%.||||<0.05
71059458|NCT04917861|141625895|OTHER||percentage difference|67.72|||||TWO_SIDED|95.0|55.69|77.07|||||Percentage Difference (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||77.07|55.69|
71059459|NCT04917861|141625895|OTHER||percentage difference|67.81|||||TWO_SIDED|95.0|55.36|77.44|||||Percentage Difference (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||77.44|55.36|
70852219|NCT03615040|141192882|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.362|TWO_SIDED|95.0|-0.14|0.35|||ANCOVA|||Pre BD FVC (litres): Analysis of covariance (ANCOVA) adjusting for the baseline value||0.35|-0.14|0.362
70852220|NCT03615040|141192882|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.713|TWO_SIDED|95.0|-0.61|0.44|||ANCOVA|||Pre BD FVC (litre):Analysis of covariance (ANCOVA) adjusting for the baseline value||0.44|-0.61|0.713
70852221|NCT03615040|141192883|SUPERIORITY||Mean Difference (Final Values)|1.78||||0.711|TWO_SIDED|95.0|-8.63|12.2|||ANCOVA|||Pre FEV1 predicted: Analysis of covariance (ANCOVA) adjusting for the baseline value||12.20|-8.63|0.711
71026715|NCT02059993|141560840|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
71059460|NCT04917861|141625895|OTHER||percentage difference|57.53|||||TWO_SIDED|95.0|43.81|69.08|||||Percentage Difference (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||69.08|43.81|
71059461|NCT04917861|141625896|OTHER||percentage difference|75.46|||||TWO_SIDED|95.0|68.12|81.49|||||Percentage Difference (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||81.49|68.12|
71059462|NCT04917861|141625896|OTHER||percentage difference|75.32|||||TWO_SIDED|95.0|67.94|81.38|||||Percentage Difference (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||81.38|67.94|
71059463|NCT04917861|141625896|OTHER||percentage difference|31.29|||||TWO_SIDED|95.0|24.23|38.96|||||Percentage Difference (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for all participants|||38.96|24.23|
71059464|NCT04917861|141625896|OTHER||percentage difference|77.78|||||TWO_SIDED|95.0|66.87|85.85|||||Percentage Difference (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||85.85|66.87|
71026716|NCT02655237|141560842|NON_INFERIORITY|The point estimate and 2-sided 95% confidence interval of the difference in the percentage were calculated between Relugolix 40 mg group and leuprorelin group (Relugolix 40 mg group - leuprorelin group), using Farrington and Manning (FM) method. If the lower boundary of the 95% CI was greater or equal to the non-inferiority margin of -15%, then the non-inferiority of Relugolix 40 mg to leuprorelin was concluded.|Difference in percentage|-0.9||||0.0013|TWO_SIDED|95.0|-10.098|8.346|||Farrington and Manning (FM)||Relugolix 40 mg-Leuprorelin|||8.346|-10.098|0.0013
71026717|NCT02655237|141560843|OTHER|The point estimate and 2-sided 95% confidence interval of the difference in the percentage were calculated between relugolix 40 mg group and leuprorelin group, using FM method with the non-inferiority margin of -15%. The confidence interval was presented in a descriptive manner and not for the purpose of statistical inference.|Difference in percentage|32.5|||||TWO_SIDED|95.0|20.953|44.134|||||Relugolix 40 mg-Leuprorelin|||44.134|20.953|
71059465|NCT04917861|141625896|OTHER||percentage difference|82.72|||||TWO_SIDED|95.0|73.02|89.43|||||Percentage Difference (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||89.43|73.02|
71059466|NCT04917861|141625896|OTHER||percentage difference|9.68|||||TWO_SIDED|95.0|4.63|17.41|||||Percentage Difference (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||17.41|4.63|
71059467|NCT04917861|141625896|OTHER||percentage difference|72.39|||||TWO_SIDED|95.0|61.56|80.83|||||Percentage Difference (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||80.83|61.56|
71059468|NCT04917861|141625896|OTHER||percentage difference|67.29|||||TWO_SIDED|95.0|55.72|76.78|||||Percentage Difference (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||76.78|55.72|
71059469|NCT04917861|141625896|OTHER||percentage difference|63.35|||||TWO_SIDED|95.0|50.75|74.0|||||Percentage Difference (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||74.00|50.75|
71077974|NCT00703326|141664446|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.95||||0.487|TWO_SIDED|95.0|0.81|1.1||The gate-keeping strategy used to control overall type 1 error 0.05 (2-sided) or 0.025 (1-sided) to analyze progression-free survival (PFS) and OS. At final PFS analysis only if primary PFS test was significant would analysis of OS be inferential.|Stratified Log Rank (SLR)|SLR used Interactive Web Response System (IWRS) factors: prior taxane therapy, visceral metastasis, hormone receptor status and geographical regions.|HR with 95% confidence interval (CI) was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors.|||1.10|0.81|0.487
70935719|NCT01802333|141372449|OTHER|||||||0.42|||||||Regression, Cox|Adjusted for: Age (\< 40 vs. \>= 40) and Onset of AML (de novo vs. treatment related and/or AML arising from antecedent hematologic disease)||Arm II was compared with Arm III using a two-sided test of the null hypothesis (HR=1) at the 0.045 level.||||0.42
70935720|NCT01802333|141372450|OTHER||||||<|0.0001|||||||Exact binomial test, 1-sided|||||||<0.0001
70935721|NCT01802333|141372452|OTHER|||||||0.52|||||||Regression, Cox|Adjusted for: Age (\< 40 vs. \>= 40) and Onset of AML (de novo vs. treatment related and/or AML arising from antecedent hematologic disease)||Arm I was compared with Arm II using a two-sided test of the null hypothesis (HR=1).||||0.52
70935722|NCT01947491|141372468|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70935723|NCT00704340|141372477|SUPERIORITY_OR_OTHER|||||||0.613|||||||t-test, 2 sided|||The sample size was selected to provide sufficient precision for 95% confidence intervals for the incidence of neurosurgical complications in each arm. The sample size was selected so that the half-width of the normal approximation-based intervals would be no more than 0.05 percentage points. This requires a sample size of 114 evaluable patients in each arm. To allow for loss to follow-up, the sample size was increased to 125 randomized patients in each treatment arm, or a total of 250 patients.||||.613
70935724|NCT00704340|141372478|SUPERIORITY_OR_OTHER|||||||0.681|||||||t-test, 2 sided|||||||.681
71026718|NCT02655237|141560844|OTHER|The point estimate and 2-sided 95% confidence interval of the difference in the percentage were calculated between relugolix 40 mg group and leuprorelin group, using FM method with the non-inferiority margin of -15%. The confidence interval was presented in a descriptive manner and not for the purpose of statistical inference.|Difference in percentage|-10.6|||||TWO_SIDED|95.0|-18.337|-2.883|||||Relugolix 40 mg-Leuprorelin|||-2.883|-18.337|
71026719|NCT02655237|141560845|OTHER|The point estimate and 2-sided 95% confidence interval of the difference in the percentage were calculated between relugolix 40 mg group and leuprorelin group, using FM method with the non-inferiority margin of -15%. The confidence interval was presented in a descriptive manner and not for the purpose of statistical inference.|Difference in percentage|-13.3|||||TWO_SIDED|95.0|-21.418|-5.118|||||Relugolix 40 mg-Leuprorelin|||-5.118|-21.418|
70935725|NCT00704340|141372479|SUPERIORITY_OR_OTHER|||||||0.619|||||||t-test, 2 sided|||||||.619
70935726|NCT03137784|141372480|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.089|||<|0.001|TWO_SIDED|95.0|0.047|0.132|||Linear Mixed Model|||||0.132|0.047|<0.001
70935727|NCT03137784|141372480|OTHER||Linear Mixed Model (LMM)|0.09|||<|0.001|TWO_SIDED|95.0|0.047|0.132|||Linear Mixed Model|||||0.132|0.047|<0.001
70935728|NCT03137784|141372481|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.165|||<|0.001|TWO_SIDED|95.0|0.127|0.203|||Linear Mixed Model|||||0.203|0.127|<0.001
70935729|NCT03137784|141372481|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.168|||<|0.001|TWO_SIDED|95.0|0.129|0.206|||Linear Mixed Model|||||0.206|0.129|<0.001
70935730|NCT03137784|141372482|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.176|||<|0.001|TWO_SIDED|95.0|0.141|0.212|||Linear Mixed Model|||||0.212|0.141|<0.001
70935731|NCT03137784|141372482|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.179|||<|0.001|TWO_SIDED|95.0|0.144|0.215|||Linear Mixed Model|||||0.215|0.144|<0.001
70935732|NCT03137784|141372483|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.139|||<|0.001|TWO_SIDED|95.0|0.106|0.173|||Linear Mixed Model|||||0.173|0.106|<0.001
70935733|NCT03137784|141372483|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.146|||<|0.001|TWO_SIDED|95.0|0.112|0.179|||Linear Mixed Model|||||0.179|0.112|<0.001
70935734|NCT03137784|141372484|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.164|||<|0.001|TWO_SIDED|95.0|0.127|0.201|||Linear Mixed Model|||||0.201|0.127|<0.001
70935735|NCT03137784|141372484|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.174|||<|0.001|TWO_SIDED|95.0|0.137|0.211|||Linear Mixed Model|||||0.211|0.137|<0.001
71026720|NCT02655237|141560846|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-12.05|||||TWO_SIDED|95.0|-19.778|-4.33|||||Relugolix 40 mg-Leuprorelin|Week 2||-4.330|-19.778|
71026721|NCT02655237|141560846|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-2.55|||||TWO_SIDED|95.0|-11.916|6.819|||||Relugolix 40 mg-Leuprorelin|Week 4||6.819|-11.916|
70852222|NCT03615040|141192883|SUPERIORITY||Mean Difference (Final Values)|-10.4||||0.214|TWO_SIDED|95.0|-27.9|7.1|||ANCOVA|||Pre BD FVC predicted (%): Analysis of covariance (ANCOVA) adjusting for the baseline value||7.1|-27.9|0.214
70935736|NCT03137784|141372485|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.036||||0.079|TWO_SIDED|95.0|-0.004|0.077|||Linear Mixed Model|||||0.077|-0.004|0.079
70935737|NCT03137784|141372485|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.058||||0.006|TWO_SIDED|95.0|0.017|0.099|||Linear Mixed Model|||||0.099|0.017|0.006
70935738|NCT03137784|141372487|OTHER|Treatment difference|Linear Mixed Model (LMM)|25.51|||<|0.001|TWO_SIDED|95.0|19.22|31.79|||Linear Mixed Model||LS Mean of change from baseline in mean morning PEF is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates|||31.79|19.22|<0.001
70935739|NCT03137784|141372487|OTHER|Treatment difference|Linear Mixed Model (LMM)|24.29|||<|0.001|TWO_SIDED|95.0|17.99|30.59|||Linear Mixed Model|||||30.59|17.99|<0.001
70935740|NCT03137784|141372488|OTHER|Treatment difference|Linear Mixed Model (LMM)|30.95|||<|0.001|TWO_SIDED|95.0|25.07|36.82|||Linear Mixed Model||LS Mean of change from baseline in mean morning PEF is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates|||36.82|25.07|<0.001
70935741|NCT03137784|141372488|OTHER|Treatment difference|Linear Mixed Model (LMM)|29.37|||<|0.001|TWO_SIDED|95.0|23.47|35.26|||Linear Mixed Model||LS Mean of change from baseline in mean morning PEF is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates|||35.26|23.47|<0.001
70935742|NCT03137784|141372489|OTHER|Treatment difference|Linear Mixed Model (LMM)|-0.15||||0.053|TWO_SIDED|95.0|-0.31|0.0|||Linear Mixed Model|||||0.00|-0.31|0.053
70935743|NCT03137784|141372489|OTHER|Treatment difference|Linear Mixed Model (LMM)|-0.11||||0.163|TWO_SIDED|95.0|-0.27|0.05|||Linear Mixed Model|||||0.05|-0.27|0.163
70935744|NCT02736188|141372491|SUPERIORITY||LS Mean Difference|0.8||||0.4287|TWO_SIDED|95.0|-1.17|2.77||Baseline is fit into the model as a covariate.|generalized estimating equation (GEE)|||Week 8||2.77|-1.17|0.4287
70852223|NCT03615040|141192884|SUPERIORITY||Mean Difference (Final Values)|-2.95||||0.201|TWO_SIDED|95.0|-7.53|1.65||To compare change from baseline to 48 weeks (pre and post treatment measurements), analysis of covariance (ANCOVA) model with baseline value as a covariate was fitted. Adjusted mean difference with 95% confidence interval and p-value were reported.|ANCOVA|||Residual Volume/Total Lung Capacity ratio.||1.65|-7.53|0.201
70935745|NCT02736188|141372491|SUPERIORITY||LS Mean Difference|0.36||||0.7031|TWO_SIDED|95.0|-1.49|2.21||Baseline is fit into the model as a covariate.|GEE model|||Week 16||2.21|-1.49|0.7031
70935746|NCT02736188|141372491|SUPERIORITY||LS Mean Difference|-0.91||||0.4253|TWO_SIDED|95.0|-3.14|1.32||Baseline is fit into the model as a covariate.|GEE model|||Week 24||1.32|-3.14|0.4253
70935747|NCT02736188|141372491|SUPERIORITY||LS Mean Difference|-0.06||||0.9747|TWO_SIDED|95.0|-3.49|3.38||Baseline is fit into the model as a covariate.|GEE model|||Week 48||3.38|-3.49|0.9747
70935748|NCT02736188|141372492|SUPERIORITY||LS Mean Difference|-0.27||||0.4721|TWO_SIDED|95.0|-1.01|0.47||Baseline is fit into the model as a covariate.|GEE model|||Week 8||0.47|-1.01|0.4721
71026722|NCT02655237|141560846|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|4.69|||||TWO_SIDED|95.0|-3.141|12.529|||||Relugolix 40 mg-Leuprorelin|Week 8||12.529|-3.141|
71059470|NCT06389487|141625910|NON_INFERIORITY|Non-Inferiority (NI) was to be demonstrated if the upper limit of the 95% confidence interval (CI) of the group GMT ratio between Part A:RSV-OA Group over Part A:RSV-A-AIR Group at 1 month post RSVPreF3 OA vaccine administration was less than or equal to (≤) 1.5.|GMT Ratio|0.72|||||TWO_SIDED|95.0|0.64|0.81|||||The comparison is done using the group ratio of adjusted GMT (Part A:RSV-OA/ Part A:RSV-A-AIR) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the humoral immune response in participants aged 18-49 YOA at increased risk for RSV disease (Part A:RSV-A-AIR Group) compared to older adults aged ≥60 YOA (Part A:RSV-OA Group) for the RSV-A strain after RSVPreF3 OA investigational vaccine administration.||0.81|0.64|
70935749|NCT02736188|141372492|SUPERIORITY||LS Mean Difference|-0.19||||0.6611|TWO_SIDED|95.0|-1.02|0.64||Baseline is fit into the model as a covariate.|GEE model|||Week 16||0.64|-1.02|0.6611
70935750|NCT02736188|141372492|SUPERIORITY||LS Mean Difference|-0.44||||0.276|TWO_SIDED|95.0|-1.22|0.35|||GEE model|Baseline is fit into the model as a covariate.||Week 24||0.35|-1.22|0.2760
70852224|NCT03615040|141192885|SUPERIORITY||Geometric mean ratio|0.75||||0.114|TWO_SIDED|95.0|0.52|1.07||A mixed effect linear model of the log outcome with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and log baseline score as fixed effects|Mixed Models Analysis|||Macrophage count||1.07|0.52|0.114
70935751|NCT02736188|141372492|SUPERIORITY||LS Mean Difference|-0.28||||0.6977|TWO_SIDED|95.0|-1.69|1.13||Baseline is fit into the model as a covariate.|GEE model|||Week 48||1.13|-1.69|0.6977
70935752|NCT02736188|141372493|SUPERIORITY||Difference in LS Means|0.7||||0.0648|TWO_SIDED|95.0|-0.04|1.45||Baseline is fit into the model as a covariate.|GEE model|||Week 8||1.45|-0.04|0.0648
70935753|NCT02736188|141372493|SUPERIORITY||difference in LS means|0.74||||0.0692|TWO_SIDED|95.0|-0.06|1.55||Baseline is fit into the model as a covariate.|GEE model|||Week 16||1.55|-0.06|0.0692
70935754|NCT02736188|141372493|SUPERIORITY||difference in LS means|0.44||||0.4317|TWO_SIDED|95.0|-0.65|1.52||Baseline is fit into the model as a covariate.|GEE model|||Week 24||1.52|-0.65|0.4317
70935755|NCT02736188|141372493|SUPERIORITY||difference in LS means|-0.34||||0.6416|TWO_SIDED|95.0|-1.78|1.1||Baseline is fit into the model as a covariate.|GEE model|||Week 48||1.10|-1.78|0.6416
70935756|NCT02736188|141372494|SUPERIORITY||difference in LS means|0.78||||0.6546|TWO_SIDED|95.0|-2.65|4.22||Baseline is fit into the model as a covariate.|GEE model|||Week 8||4.22|-2.65|0.6546
70935757|NCT02736188|141372494|SUPERIORITY||difference in LS means|-0.64||||0.7054|TWO_SIDED|95.0|-3.97|2.69||Baseline is fit into the model as a covariate.|GEE model|||Week 16||2.69|-3.97|0.7054
70935758|NCT02736188|141372494|SUPERIORITY||difference in LS means|-0.5||||0.8441|TWO_SIDED|95.0|-5.45|4.45||Baseline is fit into the model as a covariate.|GEE model|||Week 24||4.45|-5.45|0.8441
70935759|NCT02736188|141372494|SUPERIORITY||difference in LS means|4.15||||0.0864|TWO_SIDED|95.0|-0.59|8.9||Baseline is fit into the model as a covariate.|GEE model|||Week 48||8.90|-0.59|0.0864
70935760|NCT02736188|141372495|SUPERIORITY||difference in LS means|0.06||||0.8603|TWO_SIDED|95.0|-0.65|0.78||Baseline is fit into the model as a covariate.|GEE model|||Week 8||0.78|-0.65|0.8603
71026723|NCT02655237|141560846|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|3.59|||||TWO_SIDED|95.0|-3.433|10.605|||||Relugolix 40 mg-Leuprorelin|Week 12||10.605|-3.433|
71026724|NCT02655237|141560846|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|3.96|||||TWO_SIDED|95.0|-3.319|11.245|||||Relugolix 40 mg-Leuprorelin|Week 24||11.245|-3.319|
71026725|NCT02655237|141560847|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-15.15|||||TWO_SIDED|95.0|-20.786|-9.509|||||Relugolix 40 mg-Leuprorelin|Week 2||-9.509|-20.786|
71026726|NCT02655237|141560847|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-10.27|||||TWO_SIDED|95.0|-17.291|-3.246|||||Relugolix 40 mg-Leuprorelin|Week 4||-3.246|-17.291|
71026727|NCT02655237|141560847|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-0.89|||||TWO_SIDED|95.0|-6.996|5.209|||||Relugolix 40 mg-Leuprorelin|Week 8||5.209|-6.996|
71026728|NCT02655237|141560847|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-0.94|||||TWO_SIDED|95.0|-6.964|5.076|||||Relugolix 40 mg-Leuprorelin|Week 12||5.076|-6.964|
71059471|NCT06389487|141625911|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 95% CI of the group SRR difference between Part A:RSV-OA Group and Part A:RSV-A-AIR Group at 1 month post RSVPreF3 OA vaccine administration was ≤10%.|Difference in percentage|-9.33|||||TWO_SIDED|95.0|-14.55|-4.1|||||The comparison is done using the difference of SRR (Part A:RSV-OA - Part A:RSV-A-AIR).|To demonstrate the non-inferiority of the humoral immune response in participants aged 18-49 YOA at increased risk for RSV disease (Part A:RSV-A-AIR Group) compared to older adults aged ≥60 YOA (Part A:RSV-OA Group) for the RSV-A strain after RSVPreF3 OA investigational vaccine administration.||-4.10|-14.55|
71059472|NCT06389487|141625912|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 95% CI of the group GMT ratio between Part A:RSV-OA Group over Part A:RSV-A-AIR Group at 1 month post RSVPreF3 OA vaccine administration was ≤1.5.|GMT Ratio|0.73|||||TWO_SIDED|95.0|0.65|0.82|||||The comparison is done using the group ratio of adjusted GMT (Part A:RSV-OA/ Part A:RSV-A-AIR) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the humoral immune response in participants aged 18-49 YOA at increased risk for RSV disease (Part A:RSV-A-AIR Group) compared to older adults aged ≥60 YOA (Part A:RSV-OA Group) for the RSV-B strain after RSVPreF3 OA investigational vaccine administration.||0.82|0.65|
71059473|NCT06389487|141625913|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 95% CI of the group SRR difference between Part A:RSV-OA Group and Part A:RSV-A-AIR Group at 1 month post RSVPreF3 OA vaccine administration was ≤10%.|Difference in percentage|-10.03|||||TWO_SIDED|95.0|-15.26|-4.8|||||The comparison is done using the difference of SRR (Part A:RSV-OA - Part A:RSV-A-AIR).|To demonstrate the non-inferiority of the humoral immune response in participants aged 18-49 YOA at increased risk for RSV disease (Part A:RSV-A-AIR Group) compared to older adults aged ≥60 YOA (Part A:RSV-OA Group) for the RSV-B strain after RSVPreF3 OA investigational vaccine administration.||-4.80|-15.26|
71059474|NCT04479852|141625922|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.133|TWO_SIDED|95.0|-4.1|0.5|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in MADRS score from baseline.|||0.5|-4.1|0.133
71059475|NCT04479852|141625923|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.059|TWO_SIDED|95.0|-0.5|0.0|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in CGI-S score from baseline.|||0.0|-0.5|0.059
71059476|NCT04479852|141625924|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.159|TWO_SIDED|95.0|-2.7|0.4|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in HAM-D score from baseline.|||0.4|-2.7|0.159
71059477|NCT04479852|141625925|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.188|TWO_SIDED|95.0|-2.5|0.5|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in SDS score from baseline.|||0.5|-2.5|0.188
71059478|NCT04479852|141625926|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.091|TWO_SIDED|95.0|-2.0|0.2|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in QIDS score from baseline.|||0.2|-2.0|0.091
71059479|NCT04479852|141625927|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.243|TWO_SIDED|95.0|-1.2|4.6|||Mixed Models Analysis||A positive difference favors the SP-624 treatment group, i.e., a greater increase in Q-LES-Q score from baseline.|||4.6|-1.2|0.243
71059480|NCT04479852|141625928|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.008|TWO_SIDED|95.0|-6.8|-1.0|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in MADRS score from baseline.|||-1.0|-6.8|.008
71059481|NCT04479852|141625929|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.006|TWO_SIDED|95.0|-0.8|-0.1|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in CGI-S score from baseline.|||-0.1|-0.8|0.006
71059482|NCT04479852|141625930|SUPERIORITY||Mean Difference (Final Values)|2.7||||0.134|TWO_SIDED|95.0|-0.8|6.3|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in MADRS score from baseline.|||6.3|-0.8|0.134
70935761|NCT02736188|141372495|SUPERIORITY||difference in LS means|-0.18||||0.6154|TWO_SIDED|95.0|-0.86|0.51||Baseline is fit into the model as a covariate.|GEE model|||Week 16||0.51|-0.86|0.6154
71059483|NCT04479852|141625931|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.437|TWO_SIDED|95.0|-0.3|0.6|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in CGI-S score from baseline.|||0.6|-0.3|0.437
71059484|NCT00970593|141625973|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.75|STANDARD_ERROR_OF_MEAN|0.526|||TWO_SIDED|95.0|-1.79|0.29||||||The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.||0.29|-1.79|
71059485|NCT00970593|141625973|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.543|||TWO_SIDED|95.0|-2.98|-0.83||||||The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.||-0.83|-2.98|
71059486|NCT00970593|141625973|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.15|STANDARD_ERROR_OF_MEAN|0.458|||TWO_SIDED|95.0|-3.06|-1.24||||||The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.||-1.24|-3.06|
70852225|NCT03615040|141192886|SUPERIORITY||Geometric mean ratio|0.79||||0.215|TWO_SIDED|95.0|0.54|1.15||A mixed effect linear model of the log outcome with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and log baseline score as fixed effects.|Mixed Models Analysis|||Epithelium count||1.15|0.54|0.215
71059487|NCT00970593|141625974|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-2.37|STANDARD_ERROR_OF_MEAN|0.58|||TWO_SIDED|95.0|-3.52|-1.22||||||The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.||-1.22|-3.52|
71059488|NCT00970593|141625974|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.18|STANDARD_ERROR_OF_MEAN|0.495|||TWO_SIDED|95.0|-4.16|-2.2||||||The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.||-2.20|-4.16|
71059489|NCT00970593|141625974|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.14|STANDARD_ERROR_OF_MEAN|0.437|||TWO_SIDED|95.0|-4.01|-2.28||||||The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.||-2.28|-4.01|
71059490|NCT04090125|141626024|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.485|TWO_SIDED|95.0|-0.9|0.43|||Mixed Models Analysis|||||0.43|-0.90|0.485
71059491|NCT04090125|141626025|SUPERIORITY||Mean Difference (Final Values)|-0.53||||0.0887|TWO_SIDED|95.0|-1.13|0.08|||Mixed Models Analysis|||||0.08|-1.13|0.0887
71059492|NCT04090125|141626026|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.296|TWO_SIDED|95.0|-0.05|0.13|||Mixed Models Analysis|||||0.13|-0.05|0.296
71059493|NCT04090125|141626027|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.094|TWO_SIDED|95.0|-0.15|0.01|||Mixed Models Analysis|||||0.01|-0.15|0.094
71059494|NCT04090125|141626028|SUPERIORITY||Mean Difference (Final Values)|3.85||||0.11|TWO_SIDED|95.0|-0.91|8.62|||Mixed Models Analysis|||||8.62|-0.91|0.11
71059495|NCT04090125|141626029|SUPERIORITY||Mean Difference (Final Values)|1.74||||0.55|TWO_SIDED|95.0|-4.1|7.59|||Mixed Models Analysis|||||7.59|-4.10|0.55
71059496|NCT04090125|141626030|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.134|TWO_SIDED|95.0|-0.34|0.05|||Mixed Models Analysis|||||0.05|-0.34|0.134
71059497|NCT04090125|141626031|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.09|TWO_SIDED|95.0|-0.38|0.03|||Mixed Models Analysis|||||0.03|-0.38|0.09
71059498|NCT04090125|141626032|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.25|TWO_SIDED|95.0|-0.16|0.04|||Mixed Models Analysis|||||0.04|-0.16|0.25
71059499|NCT04090125|141626033|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.16|TWO_SIDED|95.0|-0.22|0.04|||Mixed Models Analysis|||||0.04|-0.22|0.16
71059500|NCT04090125|141626034|SUPERIORITY||Mean Difference (Final Values)|21.36||||0.167|TWO_SIDED|95.0|-9.29|52.02|||Mixed Models Analysis|||||52.02|-9.29|0.167
71059501|NCT04090125|141626035|SUPERIORITY||Mean Difference (Final Values)|25.15||||0.189|TWO_SIDED|95.0|-12.85|63.14|||Mixed Models Analysis|||||63.14|-12.85|0.189
71109424|NCT04046939|141724276|SUPERIORITY||Mean Difference (Final Values)|0.00474||||0.9619|TWO_SIDED|95.0|-0.192|0.202||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|ANCOVA||Estimate the difference of the 75 mg BID Dexpramipexole group from placebo in change in post-bronchodilator FEV1 from Baseline to Week 12 (end of primary treatment period) in liters. A positive value indicates improvement in lung function.|An ANCOVA analysis was performed comparing the 75 mg BID dexpramipexole group to placebo.||0.202|-0.192|0.9619
71109425|NCT04046939|141724276|SUPERIORITY||Median Difference (Final Values)|0.0987||||0.3368|TWO_SIDED|95.0|-0.105|0.302||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|ANCOVA||Estimate the difference of the 37.5 mg BID Dexpramipexole group from placebo in change in post-bronchodilator FEV1 from Baseline to Week 12 (end of primary treatment period) in liters. A positive value indicates improvement in lung function.|An ANCOVA analysis was performed comparing the 37.5 mg BID dexpramipexole group to placebo.||0.302|-0.105|0.3368
71059502|NCT04090125|141626040|SUPERIORITY||Mean Difference (Final Values)|2.51||||0.42|TWO_SIDED|95.0|-3.65|8.67|||Mixed Models Analysis|||Pain subscale||8.67|-3.65|0.42
71059503|NCT04090125|141626040|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.76|TWO_SIDED|95.0|-6.29|8.57|||Mixed Models Analysis|||Symptoms subscale||8.57|-6.29|0.76
71059504|NCT04090125|141626040|SUPERIORITY||Mean Difference (Final Values)|-3.54||||0.46|TWO_SIDED|95.0|-13.2|6.12|||Mixed Models Analysis|||Quality of life subscale||6.12|-13.20|0.46
71059505|NCT04090125|141626040|SUPERIORITY||Mean Difference (Final Values)|2.54||||0.22|TWO_SIDED|95.0|-1.61|6.69|||Mixed Models Analysis|||Function in daily life||6.69|-1.61|0.22
71059506|NCT04090125|141626041|SUPERIORITY||Mean Difference (Final Values)|1.43||||0.65|TWO_SIDED|95.0|-4.98|7.85|||Mixed Models Analysis|||Pain subscale||7.85|-4.98|0.65
71059507|NCT04090125|141626041|SUPERIORITY||Mean Difference (Final Values)|3.95||||0.32|TWO_SIDED|95.0|-3.93|11.83|||Mixed Models Analysis|||Symptoms subscale||11.83|-3.93|0.32
71059508|NCT04090125|141626041|SUPERIORITY||Mean Difference (Final Values)|1.64||||0.77|TWO_SIDED|95.0|-9.61|12.89|||Mixed Models Analysis|||Quality of life||12.89|-9.61|0.77
71059509|NCT04090125|141626041|SUPERIORITY||Mean Difference (Final Values)|3.25||||0.19|TWO_SIDED|95.0|-1.67|8.17|||Mixed Models Analysis|||Function in daily life||8.17|-1.67|0.19
71059510|NCT04090125|141626042|SUPERIORITY||Mean Difference (Final Values)|-1.95||||0.191|TWO_SIDED|95.0|-4.92|1.01|||Mixed Models Analysis|||||1.01|-4.92|0.191
71059511|NCT04090125|141626043|SUPERIORITY||Mean Difference (Final Values)|-5.45||||0.0004|TWO_SIDED|95.0|-8.28|-2.62|||Mixed Models Analysis|||||-2.62|-8.28|0.0004
71059512|NCT01342081|141626044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.1|-1.3|||ANCOVA|||||-1.3|-2.1|< 0.001
71059513|NCT01342081|141626044|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 1.5 mmHg was used. Non-inferiority was claimed if the upper limit of the confidence interval of the difference is 1.5 mmHg or less.|Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-0.7|0.1||||||Non-inferiority was evaluated after superiority to tafluprost was confirmed.||0.1|-0.7|
71059514|NCT01608100|141626045|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9326|||||TWO_SIDED|95.0|0.9048|0.9604||||||Time point: 0-2 hours||0.9604|0.9048|
71059515|NCT01608100|141626045|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9431|||||TWO_SIDED|95.0|0.9081|0.9782||||||Time point: 2-4 hours||0.9782|0.9081|
71059516|NCT01608100|141626045|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9503|||||TWO_SIDED|95.0|0.9419|0.9857||||||Time point: 4-9 hours||0.9857|0.9419|
71059517|NCT01608100|141626045|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9197|||||TWO_SIDED|95.0|0.8914|0.948||||||Time point: 0-2 hours||0.9480|0.8914|
71059518|NCT01608100|141626045|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9349|||||TWO_SIDED|95.0|0.8986|0.9712||||||Time point: 2-4 hours||0.9712|0.8986|
71059519|NCT01608100|141626045|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9498|||||TWO_SIDED|95.0|0.919|0.9805||||||Time point: 4-9 hours||0.9805|0.9190|
71059520|NCT01608100|141626045|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9412|||||TWO_SIDED|95.0|0.9102|0.9722||||||Time point: 0-2 hours||0.9722|0.9102|
71059521|NCT01608100|141626045|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9419|||||TWO_SIDED|95.0|0.9041|0.9796||||||Time point: 2-4 hours||0.9796|0.9041|
71059522|NCT01608100|141626045|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9449|||||TWO_SIDED|95.0|0.9046|0.9852||||||Time point: 4-9 hours||0.9852|0.9046|
71059523|NCT01608100|141626046|SUPERIORITY_OR_OTHER||Proportion Percentage|7.0||||0.0004|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier||||0.0004
71059524|NCT01608100|141626046|SUPERIORITY_OR_OTHER||Proportion Percentage|2.31||||0.0004|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier||||0.0004
71059525|NCT01608100|141626046|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.09||||0.0011|TWO_SIDED|95.0|1.59|5.95||Likelihood Ratio|Regression, Cox|||Hazard Ratio||5.95|1.59|0.0011
71109426|NCT04046939|141724277|SUPERIORITY||Mean Difference (Final Values)|0.208||||0.4512|TWO_SIDED|95.0|-0.338|0.755||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|ANCOVA||Estimate the difference in the 150 mg BID dexpramipexole group from the placebo group in the change in AQLQ score from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement of asthma symptoms.|An ANCOVA analysis was performed comparing the 150 mg BID dexpramipexole group to placebo.||0.755|-0.338|0.4512
70935762|NCT02736188|141372495|SUPERIORITY||difference in LS means|0.47||||0.1999|TWO_SIDED|95.0|-0.25|1.2||Baseline is fit into the model as a covariate.|GEE model|||Week 24||1.20|-0.25|0.1999
71059526|NCT01608100|141626046|SUPERIORITY_OR_OTHER||Proportion Percentage|12.76|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier||||<0.0001
71059527|NCT01608100|141626046|SUPERIORITY_OR_OTHER||Proportion Percentage|3.65|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier||||<0.0001
71059528|NCT01608100|141626046|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.65|||<|0.0001|TWO_SIDED|95.0|2.21|6.05||Likelihood Ratio|Regression, Cox|||Hazard Ratio||6.05|2.21|<0.0001
71059529|NCT01608100|141626046|SUPERIORITY_OR_OTHER||Proportion Percentage|7.17|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier||||<0.0001
71059530|NCT01608100|141626046|SUPERIORITY_OR_OTHER||Proportion Percentage|2.07|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier||||<0.0001
71059531|NCT01608100|141626046|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.54||||0.0002|TWO_SIDED|95.0|1.84|6.87||Likelihood Ratio|Regression, Cox|||Hazard Ratio||6.87|1.84|0.0002
71059532|NCT01608100|141626046|SUPERIORITY_OR_OTHER||Proportion Percentage|12.83|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier||||<0.0001
71059533|NCT01608100|141626046|SUPERIORITY_OR_OTHER||Proportion Percentage|3.66|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier||||<0.0001
70852226|NCT02737891|141192889|SUPERIORITY||Mean Difference (Net)|-3.8||||0.004|TWO_SIDED|95.0|-6.36|-1.29||Two-sided p-value for test of no difference from 0.|ANCOVA|||The analysis was based on a parametric model, i.e. compared between treatment arms by means of an analysis of covariance (ANCOVA) model (proc MIXED) using change from baseline to the end of treatment as dependent variable, treatment and study site as fixed effects and the value from baseline as covariate. The residual errors were assumed independent and identically distributed (i.i.d.) and normally distributed.||-1.29|-6.36|0.004
70852227|NCT02737891|141192890|SUPERIORITY||Mean Difference (Net)|0.1||||0.724|TWO_SIDED|95.0|-0.23|0.33||Two-sided p-value for test of no difference from 0.|ANCOVA|||The analysis was based on a parametric model, i.e. compared between treatment arms by means of an analysis of covariance (ANCOVA) model (proc MIXED) using change from baseline to the end of treatment as dependent variable, treatment and study site as fixed effects and the value from baseline as covariate. The residual errors were assumed independent and identically distributed (i.i.d.) and normally distributed.||0.33|-0.23|0.724
70852228|NCT02737891|141192891|SUPERIORITY||Mean Difference (Net)|-3.5|||<|0.0001|TWO_SIDED|95.0|-4.65|-2.3||Two-sided p-value for test of no difference from 0.|ANCOVA|||The analysis was based on a parametric model, i.e. compared between treatment arms by means of an analysis of covariance (ANCOVA) model (proc MIXED) using change from baseline to the end of treatment as dependent variable, treatment and study site as fixed effects and the value from baseline as covariate. The residual errors were assumed independent and identically distributed (i.i.d.) and normally distributed.||-2.30|-4.65|<0.0001
70852229|NCT05194579|141192892|EQUIVALENCE|Pharmacokinetic equivalence were assessed by constructing the 90% confidence intervals (CIs) for the GMR (test/reference) for Cmax, AUClast and AUCinf. This table displays Cmax statistical analysis.|Ratio of Geometric Mean|117.06|||||TWO_SIDED|90.0|103.07|132.93|||ANOVA|||The null hypothesis was PF-06881894 OBI was not equivalent to PF-06881894 PFS.||132.93|103.07|
70852230|NCT05194579|141192893|EQUIVALENCE|Pharmacokinetic equivalence were assessed by constructing the 90% CIs for the GMR (test/reference) for Cmax, AUClast and AUCinf. This table displays AUClast statistical analysis.|Ratio of Geometric Mean|122.12|||||TWO_SIDED|90.0|107.9|138.22|||ANOVA|||The null hypothesis was PF-06881894 OBI was not equivalent to PF-06881894 PFS.||138.22|107.90|
70935763|NCT02736188|141372495|SUPERIORITY||difference in LS means|-0.03||||0.9568|TWO_SIDED|95.0|-1.25|1.18||Baseline is fit into the model as a covariate.|GEE model|||Week 48||1.18|-1.25|0.9568
71059534|NCT01608100|141626046|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.68|||<|0.0001|TWO_SIDED|95.0|2.25|6.05||Likelihood Ratio|Regression, Cox|||Hazard Ratio||6.05|2.25|<0.0001
71059535|NCT01608100|141626046|SUPERIORITY_OR_OTHER||Proportion Percentage|6.07||||0.002|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier||||0.0020
71059536|NCT01608100|141626046|SUPERIORITY_OR_OTHER||Proportion Percentage|2.09||||0.002|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier||||0.0020
71059537|NCT01608100|141626046|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.95||||0.005|TWO_SIDED|95.0|1.41|6.05||Likelihood Ratio|Regression, Cox|||Hazard Ratio||6.05|1.41|0.0050
71059538|NCT01608100|141626046|SUPERIORITY_OR_OTHER||Proportion Percentage|12.15|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier||||<0.0001
71059539|NCT01608100|141626046|SUPERIORITY_OR_OTHER||Proportion Percentage|3.57|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier||||<0.0001
71059540|NCT01608100|141626046|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.55|||<|0.0001|TWO_SIDED|95.0|2.08|6.03||Likelihood Ratio|Regression, Cox|||Hazard Ratio||6.03|2.08|<0.0001
71059541|NCT01608100|141626047|SUPERIORITY_OR_OTHER||Percent Sensitivity|84.44|||||TWO_SIDED|95.0|75.28|91.23||||||Time point: 0-2 hours||91.23|75.28|
71059542|NCT01608100|141626047|SUPERIORITY_OR_OTHER||Percent Sensitivity|92.21|||||TWO_SIDED|83.81|83.81|97.09||||||Time point: 2-4 hours||97.09|83.81|
71059543|NCT01608100|141626047|SUPERIORITY_OR_OTHER||Percent Sensitivity|93.9|||||TWO_SIDED|95.0|86.34|97.99||||||Time point: 4-9 hours||97.99|86.34|
71109427|NCT04046939|141724277|SUPERIORITY||Mean Difference (Final Values)|-0.0642||||0.8214|TWO_SIDED|95.0|-0.627|0.499||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|ANCOVA||Estimate the difference in the 75 mg BID dexpramipexole group from the placebo group in the change in AQLQ score from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement of asthma symptoms.|An ANCOVA analysis was performed comparing the 75 mg BID dexpramipexole group to placebo.||0.499|-0.627|0.8214
71109428|NCT04046939|141724277|SUPERIORITY||Mean Difference (Final Values)|0.154||||0.5894|TWO_SIDED|95.0|-0.411|0.72||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|ANCOVA||Estimate the difference in the 37.5 mg BID dexpramipexole group from the placebo group in the change in AQLQ score from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement of asthma symptoms.|An ANCOVA analysis was performed comparing the 37.5 mg BID dexpramipexole group to placebo.||0.720|-0.411|0.5894
71026729|NCT02655237|141560847|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|0.86|||||TWO_SIDED|95.0|-6.206|7.935|||||Relugolix 40 mg-Leuprorelin|Week 24||7.935|-6.206|
71059544|NCT01608100|141626047|SUPERIORITY_OR_OTHER||Percent Sensitivity|85.26|||||TWO_SIDED|95.0|76.51|91.7||||||Time point: 0-2 hours||91.70|76.51|
71059545|NCT01608100|141626047|SUPERIORITY_OR_OTHER||Percent Sensitivity|91.86|||||TWO_SIDED|95.0|83.95|96.66||||||Time point: 2-4 hours||96.66|83.95|
71059546|NCT01608100|141626047|SUPERIORITY_OR_OTHER||Percent Sensitivity|94.95|||||TWO_SIDED|95.0|88.61|98.34||||||Time point: 4-9 hours||98.34|88.61|
71059547|NCT01608100|141626047|SUPERIORITY_OR_OTHER||Percent Sensitivity|87.32|||||TWO_SIDED|95.0|77.3|94.04||||||Time point: 0-2 hours||94.04|77.30|
71109429|NCT04046939|141724283|SUPERIORITY|||||||0.0196||||||No adjustment for multiple testing of exploratory endpoints was used.|Wilcoxon (Mann-Whitney)|||The 150 mg BID dexpramipexole group was compared to placebo at Week 12 using a Wilcoxon rank sum test.||||0.0196
70852231|NCT05194579|141192894|EQUIVALENCE|Pharmacokinetic equivalence were assessed by constructing the 90% CIs for the GMR (test/reference) for Cmax, AUClast and AUCinf. This table displays AUCinf statistical analysis.|Ratio of Geometric Mean|123.75|||||TWO_SIDED|90.0|108.75|140.82|||ANOVA|||The null hypothesis was PF-06881894 OBI was not equivalent to PF-06881894 PFS.||140.82|108.75|
70852232|NCT04145219|141192898|SUPERIORITY||Mean Difference (Final Values)|1.0|||<|0.0001|TWO_SIDED|95.0|0.5|1.4||This endpoint was controlled for multiplicity using hierarchical testing|Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average daily TCRS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||1.4|0.5|<0.0001
70852233|NCT04145219|141192899|SUPERIORITY||Mean Difference (Final Values)|0.4|||<|0.0001|TWO_SIDED|95.0|0.2|0.6||This endpoint was controlled for multiplicity using hierarchical testing|Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average rhinitis DSS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.6|0.2|<0.0001
70852234|NCT04145219|141192900|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.0016|TWO_SIDED|95.0|0.2|0.8||This endpoint was controlled for multiplicity using hierarchical testing|Mixed Models Analysis|||The average rhinitis DMS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.8|0.2|0.0016
70852235|NCT04145219|141192901|SUPERIORITY||Mean Difference (Final Values)|1.1|||<|0.0001|TWO_SIDED|95.0|0.6|1.7||This endpoint was controlled for multiplicity using hierarchical testing|Mixed Models Analysis||Placebo vs.12 SQ-HDM|||1.7|0.6|<0.0001
70935764|NCT02736188|141372496|SUPERIORITY||difference in LS means|0.45||||0.5447|TWO_SIDED|95.0|-1.0|1.9||Baseline is fit into the model as a covariate.|GEE model|||Week 8||1.90|-1.00|0.5447
70935765|NCT02736188|141372496|SUPERIORITY||difference in LS means|-0.56||||0.5051|TWO_SIDED|95.0|-2.22|1.09||Baseline is fit into the model as a covariate.|GEE model|||Week 16||1.09|-2.22|0.5051
71026730|NCT02655237|141560848|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.2|||||TWO_SIDED|95.0|0.015|0.381|||||Relugolix 40 mg-Leuprorelin|Week 4||0.381|0.015|
71059548|NCT01608100|141626047|SUPERIORITY_OR_OTHER||Percent Sensitivity|92.0|||||TWO_SIDED|95.0|83.4|97.01||||||Time point: 2-4 hours||97.01|83.40|
71059549|NCT01608100|141626047|SUPERIORITY_OR_OTHER||Percent Sensitivity|93.15|||||TWO_SIDED|95.0|84.74|97.74||||||Time point: 4-9 hours||97.74|84.74|
71059550|NCT01608100|141626048|SUPERIORITY_OR_OTHER||Percent Specificity|85.73|||||TWO_SIDED|95.0|83.18|88.03||||||Time point: 0-2 hours||88.03|83.18|
71059551|NCT01608100|141626048|SUPERIORITY_OR_OTHER||Percent Specificity|85.2|||||TWO_SIDED|95.0|82.66|87.5||||||Time point: 2-4 hours||87.50|82.66|
71059552|NCT01608100|141626048|SUPERIORITY_OR_OTHER||Percent Specificity|82.82|||||TWO_SIDED|95.0|79.99|85.4||||||Time point: 4-9 hours||85.40|79.99|
71059553|NCT01608100|141626048|SUPERIORITY_OR_OTHER||Percent Specificity|83.76|||||TWO_SIDED|95.0|81.12|86.17||||||Time point: 0-2 hours||86.17|81.12|
71059554|NCT01608100|141626048|SUPERIORITY_OR_OTHER||Percent Specificity|83.72|||||TWO_SIDED|95.0|81.09|86.11||||||Time point: 2-4 hours||86.11|81.09|
71059555|NCT01608100|141626048|SUPERIORITY_OR_OTHER||Percent Specificity|80.72|||||TWO_SIDED|95.0|77.82|83.39||||||Time point: 4-9 hours||83.39|77.82|
71059556|NCT01608100|141626048|SUPERIORITY_OR_OTHER||Percent Specificity|86.35|||||TWO_SIDED|95.0|83.79|88.63||||||Time point: 0-2 hours||88.63|83.79|
71059557|NCT01608100|141626048|SUPERIORITY_OR_OTHER||Percent Specificity|85.81|||||TWO_SIDED|95.0|83.31|88.07||||||Time point: 2-4 hours||88.07|83.31|
71059558|NCT01608100|141626048|SUPERIORITY_OR_OTHER||Percent Specificity|84.05|||||TWO_SIDED|95.0|81.31|86.54||||||Time point: 4-9 hours||86.54|81.31|
70935766|NCT02736188|141372496|SUPERIORITY||difference in LS means|0.27||||0.7478|TWO_SIDED|95.0|-1.36|1.9||Baseline is fit into the model as a covariate.|GEE model|||Week 24||1.90|-1.36|0.7478
70935767|NCT02736188|141372496|SUPERIORITY||difference in LS means|-0.41||||0.7429|TWO_SIDED|95.0|-2.86|2.04||Baseline is fit into the model as a covariate.|GEE model|||Week 48||2.04|-2.86|0.7429
70935768|NCT02736188|141372497|SUPERIORITY||difference in LS means|2.0||||0.6434|TWO_SIDED|95.0|-6.48|10.49||Baseline is fit into the model as a covariate.|GEE model|||Week 8||10.49|-6.48|0.6434
70935769|NCT02736188|141372497|SUPERIORITY||difference in LS means|-1.99||||0.7118|TWO_SIDED|95.0|-12.53|8.55||Baseline is fit into the model as a covariate.|GEE model|||Week 16||8.55|-12.53|0.7118
70935770|NCT02736188|141372497|SUPERIORITY||difference in LS means|4.15||||0.4399|TWO_SIDED|95.0|-6.39|14.69||Baseline is fit into the model as a covariate.|GEE model|||Week 24||14.69|-6.39|0.4399
70935771|NCT02736188|141372497|SUPERIORITY||difference in LS means|7.98||||0.443|TWO_SIDED|95.0|-12.41|28.37||Baseline is fit into the model as a covariate.|GEE model|||Week 48||28.37|-12.41|0.4430
70935772|NCT02736188|141372498|SUPERIORITY||difference in LS means|0.28||||0.6428|TWO_SIDED|95.0|-0.9|1.46||Baseline is fit into the model as a covariate.|GEE model|||Week 8||1.46|-0.90|0.6428
70935773|NCT02736188|141372498|SUPERIORITY||difference in LS means|-0.25||||0.7334|TWO_SIDED|95.0|-1.72|1.21||Baseline is fit into the model as a covariate.|GEE model|||Week 16||1.21|-1.72|0.7334
71026731|NCT02655237|141560848|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.1|||||TWO_SIDED|95.0|-0.135|0.333|||||Relugolix 40 mg-Leuprorelin|Week 8||0.333|-0.135|
71026732|NCT02655237|141560848|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.07|||||TWO_SIDED|95.0|-0.189|0.323|||||Relugolix 40 mg-Leuprorelin|Week 12||0.323|-0.189|
71026733|NCT02655237|141560848|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-0.01|||||TWO_SIDED|95.0|-0.275|0.251|||||Relugolix 40 mg-Leuprorelin|Week 16||0.251|-0.275|
71026734|NCT02655237|141560848|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-0.1|||||TWO_SIDED|95.0|-0.386|0.18|||||Relugolix 40 mg-Leuprorelin|Week 20||0.180|-0.386|
71026735|NCT02655237|141560848|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-0.09|||||TWO_SIDED|95.0|-0.385|0.209|||||Relugolix 40 mg-Leuprorelin|Week 24||0.209|-0.385|
71026736|NCT02655237|141560848|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-0.49|||||TWO_SIDED|95.0|-0.787|-0.199|||||Relugolix 40 mg-Leuprorelin|Follow up (up to Week 28)||-0.199|-0.787|
71026737|NCT02655237|141560849|OTHER|Two-sided 95% confidence interval of the difference was calculated between relugolix 40 mg and leuprorelin group.|Mean Difference (Each Visit)|0.07|||||TWO_SIDED|95.0|-0.032|0.174|||||Relugolix 40 mg-Leuprorelin|Week 6 to 12||0.174|-0.032|
71026738|NCT02655237|141560849|OTHER|Two-sided 95% confidence interval of the difference was calculated between relugolix 40 mg and leuprorelin group.|Mean Difference (Each Visit)|0.05|||||TWO_SIDED|95.0|-0.089|0.197|||||Relugolix 40 mg-Leuprorelin|Week 2 to 6||0.197|-0.089|
71026739|NCT02655237|141560849|OTHER|Two-sided 95% confidence interval of the difference was calculated between relugolix 40 mg and leuprorelin group.|Mean Difference (Each Visit)|0.01|||||TWO_SIDED|95.0|-0.06|0.086|||||Relugolix 40 mg-Leuprorelin|Week 18 to 24||0.086|-0.060|
71026740|NCT02655237|141560849|OTHER|Two-sided 95% confidence interval of the difference was calculated between relugolix 40 mg and leuprorelin group.|Mean Difference (Each Visit)|0.02|||||TWO_SIDED|95.0|-0.063|0.099|||||Relugolix 40 mg-Leuprorelin|For 6 Weeks Before the Final Dose (up to Week 24)||0.099|-0.063|
71059559|NCT01608100|141626049|SUPERIORITY_OR_OTHER||Negative Predictive Value|98.1|||||TWO_SIDED|95.0|96.82|98.95||||||Time point: 0-2 hours||98.95|96.82|
70935774|NCT02736188|141372498|SUPERIORITY||difference in LS means|0.58||||0.4409|TWO_SIDED|95.0|-0.89|2.04||Baseline is fit into the model as a covariate.|GEE model|||Week 24||2.04|-0.89|0.4409
70935775|NCT02736188|141372498|SUPERIORITY||difference in LS means|0.99||||0.4687|TWO_SIDED|95.0|-1.69|3.68||Baseline is fit into the model as a covariate.|GEE model|||Week 48||3.68|-1.69|0.4687
70935776|NCT02736188|141372499|SUPERIORITY||difference in LS means|1.14||||0.1502|TWO_SIDED|95.0|-0.41|2.69||Baseline is fit into the model as a covariate.|GEE model|||Week 8||2.69|-0.41|0.1502
70935777|NCT02736188|141372499|SUPERIORITY||difference in LS means|-0.2||||0.8188|TWO_SIDED|-1.89|-1.89|1.49||Baseline is fit into the model as a covariate.|GEE model|||Week 16||1.49|-1.89|0.8188
70935778|NCT02736188|141372499|SUPERIORITY||difference in LS means|0.8||||0.5122|TWO_SIDED|95.0|-1.58|3.17||Baseline is fit into the model as a covariate.|GEE model|||Week 24||3.17|-1.58|0.5122
70935779|NCT02736188|141372499|SUPERIORITY||difference in LS means|0.72||||0.7022|TWO_SIDED|95.0|-2.96|4.4||Baseline is fit into the model as a covariate.|GEE model|||Week 48||4.40|-2.96|0.7022
70935780|NCT02736188|141372500|SUPERIORITY||difference in LS means|0.19||||0.7906|TWO_SIDED|95.0|-1.22|1.6||Baseline is fit into the model as a covariate.|GEE model|||Week 8||1.60|-1.22|0.7906
70935781|NCT02736188|141372500|SUPERIORITY||difference in LS means|0.66||||0.3531|TWO_SIDED|95.0|-0.74|2.07||Baseline is fit into the model as a covariate.|GEE model|||Week 16||2.07|-0.74|0.3531
70935782|NCT02736188|141372500|SUPERIORITY||difference in LS means|0.15||||0.8846|TWO_SIDED|95.0|-1.92|2.23||Baseline is fit into the model as a covariate.|GEE model|||Week 24||2.23|-1.92|0.8846
70935783|NCT02736188|141372500|SUPERIORITY||difference in LS means|2.08||||0.0168|TWO_SIDED|95.0|0.38|3.79||Baseline is fit into the model as a covariate.|GEE model|||Week 48||3.79|0.38|0.0168
71026741|NCT02655237|141560850|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-2.5|||||TWO_SIDED|95.0|-6.39|1.43|||||Relugolix 40 mg-Leuprorelin|Week 4||1.43|-6.39|
71059560|NCT01608100|141626049|SUPERIORITY_OR_OTHER||Negative Predictive Value|99.19|||||TWO_SIDED|95.0|98.25|99.7||||||Time point: 2-4 hours||99.70|98.25|
70935784|NCT03547154|141372530|SUPERIORITY_OR_OTHER|||||||0.322||||||Analysis of Major Response|Fisher Exact|Missing data considered failures||||||0.322
70935785|NCT03547154|141372531|SUPERIORITY_OR_OTHER||||||>|0.999||||||Analysis of Major Response|Fisher Exact|Missing data considered failures||||||>0.999
70935786|NCT03547154|141372532|SUPERIORITY_OR_OTHER|||||||0.588||||||Analysis of Complete Response|Fisher Exact|Missing data considered failures||||||0.588
70935787|NCT03547154|141372533|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.859|||||TWO_SIDED|95.0|0.429|1.721|||||Overall survival was analyzed using the log-rank statistic. The HR and 95% CI for the HR were obtained using Cox's proportional hazards model.|||1.721|0.429|
71059561|NCT01608100|141626049|SUPERIORITY_OR_OTHER||Negative Predictive Value|99.23|||||TWO_SIDED|95.0|98.22|99.75||||||Time point: 4-9 hours||99.75|98.22|
71059562|NCT01608100|141626049|SUPERIORITY_OR_OTHER||Negative Predictive Value|98.08|||||TWO_SIDED|95.0|96.81|98.95||||||Time point: 0-2 hours||98.95|96.81|
71059563|NCT01608100|141626049|SUPERIORITY_OR_OTHER||Negative Predictive Value|99.05|||||TWO_SIDED|95.0|98.05|99.62||||||Time point: 2-4 hours||99.62|98.05|
71059564|NCT01608100|141626049|SUPERIORITY_OR_OTHER||Negative Predictive Value|99.24|||||TWO_SIDED|95.0|98.22|99.75||||||Time point: 4-9 hours||99.75|98.22|
71059565|NCT01608100|141626049|SUPERIORITY_OR_OTHER||Negative Predictive Value|98.73|||||TWO_SIDED|95.0|97.61|99.42||||||Time point: 0-2 hours||99.42|97.61|
71059566|NCT01608100|141626049|SUPERIORITY_OR_OTHER||Negative Predictive Value|99.2|||||TWO_SIDED|95.0|98.27|99.71||||||Time point: 2-4 hours||99.71|98.27|
71109430|NCT04046939|141724283|SUPERIORITY|||||||0.0207||||||No adjustment for multiple testing of exploratory endpoints was used.|Wilcoxon (Mann-Whitney)|||The 75mg BID dexpramipexole group was compared to placebo at Week 12 using a Wilcoxon rank sum test.||||0.0207
71059567|NCT01608100|141626049|SUPERIORITY_OR_OTHER||Negative Predictive Value|99.25|||||TWO_SIDED|95.0|98.26|99.76||||||Time point: 4-9 hours||99.76|98.26|
71059568|NCT01608100|141626050|SUPERIORITY_OR_OTHER||Positive Predictive Value|38.78|||||TWO_SIDED|95.0|31.92|45.98||||||Time point: 0-2 hours||45.98|31.92|
71059569|NCT01608100|141626050|SUPERIORITY_OR_OTHER||Positive Predictive Value|35.68|||||TWO_SIDED|95.0|29.03|42.76||||||Time point: 2-4 hours||42.76|29.03|
71059570|NCT01608100|141626050|SUPERIORITY_OR_OTHER||Positive Predictive Value|36.49|||||TWO_SIDED|95.0|29.99|43.38||||||Time point: 4-9 hours||43.38|29.99|
71109431|NCT04046939|141724283|SUPERIORITY|||||||0.5399||||||No adjustment for multiple testing of exploratory endpoints was used.|Wilcoxon (Mann-Whitney)|||The 37.5 mg BID dexpramipexole group was compared to placebo at Week 12 using a Wilcoxon rank sum test.||||0.5399
70935788|NCT01543204|141372562|SUPERIORITY_OR_OTHER||Difference|10.0||||0.4505|TWO_SIDED|95.0|-15.97|35.97|||Wald asymptotic test|||||35.97|-15.97|0.4505
70935789|NCT02684136|141372594|SUPERIORITY||||||<|0.05|||||||ANCOVA|baseline used as covariate||||||<0.05
70935790|NCT02684136|141372595|SUPERIORITY||||||<|0.05||||||baseline used as covariate|ANCOVA|||||||<0.05
70935791|NCT00068107|141372605|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||eGFR measured pre-study was compared to eGFR during the study||||0.01
70935792|NCT00068107|141372605|SUPERIORITY_OR_OTHER||Average Delay in time to ESRD|166.0|||||TWO_SIDED|95.0|8.4|323.8|||||The average delay in end stage renal disease (ESRD) calculated from the eGFR values and represents the estimated difference in time to ESRD between Relagal administered every 2 weeks and Relagal administered weekly. Units = months|||323.8|8.4|
70935793|NCT00786188|141372624|SUPERIORITY_OR_OTHER|||||||0.0177||||||Week 4 frequency|Repeated measures analysis|||||||0.0177
71059571|NCT01608100|141626050|SUPERIORITY_OR_OTHER||Positive Predictive Value|36.82|||||TWO_SIDED|95.0|30.43|43.56||||||Time point: 0-2 hours||43.56|30.43|
71059572|NCT01608100|141626050|SUPERIORITY_OR_OTHER||Positive Predictive Value|35.75|||||TWO_SIDED|95.0|29.43|42.45||||||Time point: 2-4 hours||42.45|29.43|
71059573|NCT01608100|141626050|SUPERIORITY_OR_OTHER||Positive Predictive Value|37.75|||||TWO_SIDED|95.0|31.71|44.09||||||Time point: 4-9 hours||44.09|31.71|
71059574|NCT01608100|141626050|SUPERIORITY_OR_OTHER||Positive Predictive Value|35.84|||||TWO_SIDED|95.0|28.7|43.47||||||Time point: 0-2 hours||43.47|28.70|
71059575|NCT01608100|141626050|SUPERIORITY_OR_OTHER||Positive Predictive Value|35.94|||||TWO_SIDED|95.0|29.16|43.16||||||Time point: 2-4 hours||43.16|29.16|
71059576|NCT01608100|141626050|SUPERIORITY_OR_OTHER||Positive Predictive Value|35.05|||||TWO_SIDED|95.0|28.36|42.21||||||Time point: 4-9 hours||42.21|28.36|
71059577|NCT03440840|141626078|SUPERIORITY||Mean Difference (Final Values)|2.29|STANDARD_ERROR_OF_MEAN|2.68||0.4|TWO_SIDED||||||Mixed Models Analysis|Estimated marginal means comparisons, Tukey adjustment||||||0.40
71059578|NCT03440840|141626079|SUPERIORITY||Mean Difference (Final Values)|1.86|STANDARD_ERROR_OF_MEAN|2.04||0.37|TWO_SIDED|||||Estimated marginal means comparisons, Tukey adjustment|Mixed Models Analysis|||||||0.37
71059579|NCT03440840|141626080|SUPERIORITY||Mean Difference (Final Values)|1.86|STANDARD_ERROR_OF_MEAN|2.04||0.37|TWO_SIDED||||||Mixed Models Analysis|Comparison of estimated marginal means, Tukey adjustment for multiple comparisons||||||0.37
71059580|NCT03440840|141626081|SUPERIORITY||Mean Difference (Final Values)|1.42|STANDARD_ERROR_OF_MEAN|2.77||0.61|TWO_SIDED||||||Mixed Models Analysis||Differences between estimated marginal means, Tukey correction for multiple comparisons.|||||0.61
71059581|NCT00535405|141626157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.7|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-17.5|-12.0||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANCOVA|ANCOVA mixed model with fixed effects for treatment, baseline LDL-C, study week, treatment by study week interaction, and a random subject effect.||||-12.0|-17.5|<0.001
71059582|NCT00535405|141626157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.5|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-10.3|-4.8||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANCOVA|ANCOVA mixed model with fixed effects for treatment, baseline LDL-C, study week, treatment by study week interaction, and a random subject effect.||||-4.8|-10.3|<0.001
71117635|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
71026742|NCT02655237|141560850|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-4.0|||||TWO_SIDED|95.0|-6.68|-1.31|||||Relugolix 40 mg-Leuprorelin|Week 8||-1.31|-6.68|
71026743|NCT02655237|141560850|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.2|||||TWO_SIDED|95.0|-1.99|2.36|||||Relugolix 40 mg-Leuprorelin|Week 12||2.36|-1.99|
70935794|NCT00786188|141372624|SUPERIORITY_OR_OTHER|||||||0.0541||||||Week 8 frequency|Reapeated measures analysis|||||||0.0541
71026744|NCT02655237|141560850|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|1.3|||||TWO_SIDED|95.0|-0.68|3.28|||||Relugolix 40 mg-Leuprorelin|Week 16||3.28|-0.68|
71026745|NCT02655237|141560850|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.3|||||TWO_SIDED|95.0|-1.8|2.32|||||Relugolix 40 mg-Leuprorelin|Week 20||2.32|-1.80|
71026746|NCT02655237|141560850|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.5|||||TWO_SIDED|95.0|-1.48|2.52|||||Relugolix 40 mg-Leuprorelin|Week 24||2.52|-1.48|
71026747|NCT02655237|141560850|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|3.4|||||TWO_SIDED|95.0|1.08|5.77|||||Relugolix 40 mg-Leuprorelin|Follow-Up (up to Week 28)||5.77|1.08|
71026748|NCT02655237|141560851|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|2.3|||||TWO_SIDED|95.0|-1.66|6.34|||||Relugolix 40 mg-Leuprorelin|Week 4||6.34|-1.66|
71026749|NCT02655237|141560851|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|2.7|||||TWO_SIDED|95.0|-0.37|5.77|||||Relugolix 40 mg-Leuprorelin|Week 8||5.77|-0.37|
71026750|NCT02655237|141560851|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.9|||||TWO_SIDED|95.0|-1.84|3.61|||||Relugolix 40 mg-Leuprorelin|Week 12||3.61|-1.84|
71026751|NCT02655237|141560851|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.1|||||TWO_SIDED|95.0|-2.61|2.79|||||Relugolix 40 mg-Leuprorelin|Week 16||2.79|-2.61|
71026752|NCT02655237|141560851|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.8|||||TWO_SIDED|95.0|-1.74|3.41|||||Relugolix 40 mg-Leuprorelin|Week 20||3.41|-1.74|
71026753|NCT02655237|141560851|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.3|||||TWO_SIDED|95.0|-2.07|2.71|||||Relugolix 40 mg-Leuprorelin|Week 24||2.71|-2.07|
71026754|NCT02655237|141560851|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-1.4|||||TWO_SIDED|95.0|-3.96|1.09|||||Relugolix 40 mg-Leuprorelin|Follow-Up (up to Week 28)||1.09|-3.96|
71026755|NCT01860976|141560861|SUPERIORITY_OR_OTHER_LEGACY||Estimate of Difference|17.2|||<|0.001|TWO_SIDED|95.0|8.7|25.6|||Cochran-Mantel-Haenszel|||||25.6|8.7|<0.001
71026756|NCT02419313|141560895|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||Fisher Exact|||||||0.0007
71026757|NCT02419313|141560896|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Fisher Exact|||||||0.0008
71026758|NCT02419313|141560897|SUPERIORITY_OR_OTHER|||||||0.0105|TWO_SIDED||||||Fisher Exact|||||||0.0105
71026759|NCT00620763|141560898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|2.0||0.02||95.0|||||Mixed Models Analysis|Mixed model analysis of variance tested for treatment and feeding sequence effects.||16 subjects required to detect a difference in Calcium 47 absorption of 2 percentage points with 90% power, alpha = 0.05||||0.02
71026760|NCT02907203|141560905|NON_INFERIORITY|Compared with the Performance Goal: 0.9mm|Mean Difference (Net)|-0.17|STANDARD_DEVIATION|0.98||0|TWO_SIDED|95.0|-0.5|0.152|||t-test, 2 sided|||||0.152|-0.5|0.000
71026761|NCT01816477|141561008|SUPERIORITY_OR_OTHER|||||||0.55|||||||t-test, 2 sided|||||||0.55
71026762|NCT01816477|141561009|SUPERIORITY_OR_OTHER|||||||0.0872|||||||Unequal Variance T-Test|||Comparison between the groups for day 1.||||0.0872
71026763|NCT01816477|141561009|SUPERIORITY_OR_OTHER|||||||0.6751|||||||Unequal Variance T-Test|||Comparison between groups for day 2.||||0.6751
71026764|NCT01816477|141561009|SUPERIORITY_OR_OTHER|||||||0.1203|||||||Unequal Variance T-Test|||Comparison between groups for day 3.||||0.1203
71026765|NCT01816477|141561009|SUPERIORITY_OR_OTHER|||||||0.3582|||||||Unequal Variance T-Test|||Comparison between groups for day 4.||||0.3582
71026766|NCT01816477|141561009|SUPERIORITY_OR_OTHER|||||||0.0625|||||||Unequal Variance T-Test|||Comparison between groups for day 5||||0.0625
71026767|NCT01816477|141561009|SUPERIORITY_OR_OTHER|||||||0.0484|||||||Unequal Variance T-Test|||Comparison between groups for day 6.||||0.0484
71026768|NCT01816477|141561010|SUPERIORITY_OR_OTHER|||||||0.6465|||||||Unequal Variance T-Test|||Comparison between the groups for day 1.||||0.6465
71026769|NCT01816477|141561010|SUPERIORITY_OR_OTHER|||||||0.9233|||||||Unequal Variance T-Test|||Comparison between groups for day 2.||||0.9233
71026770|NCT01816477|141561010|SUPERIORITY_OR_OTHER|||||||0.5788|||||||Unequal Variance T-Test|||Comparison between groups for day 3.||||0.5788
71026771|NCT01816477|141561010|SUPERIORITY_OR_OTHER|||||||0.1036|||||||Unequal Variance T-Test|||Comparison between the groups for day 4.||||0.1036
71026772|NCT01816477|141561010|SUPERIORITY_OR_OTHER|||||||0.5314|||||||Unequal Variance T-Test|||Comparison between groups for day 5.||||0.5314
71026773|NCT01816477|141561010|SUPERIORITY_OR_OTHER|||||||0.7166|||||||Unequal Variance T-Test|||Comparison between groups for day 6.||||0.7166
71026774|NCT01807871|141561025|SUPERIORITY|||||||0.48|||||||Chi-squared|||||||0.48
71026775|NCT01807871|141561027|SUPERIORITY|||||||0.24|||||||Chi-squared|||Comparison of number of participants who reported removing the nicotine patch due to a side effect||||0.24
71026776|NCT00698685|141561028|SUPERIORITY_OR_OTHER||actuarial probability of engraftment|70.0||||||95.0|||||||Actuarial probability of engraftment at day +100 is calculated according to the product-limit estimate method.|||||
71026777|NCT02978326|141561045|SUPERIORITY||Least Squares (LS) Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|1.37||0.0028|TWO_SIDED|95.0|-6.9|-1.5||Mixed Model for Repeated Measures (MMRM) was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||||-1.5|-6.9|0.0028
71026778|NCT02978326|141561046|SUPERIORITY||LS Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|1.19||0.0252|TWO_SIDED|95.0|-5.1|-0.3||MMRM was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in the HAM-D Total Score at Day 3||-0.3|-5.1|0.0252
71026779|NCT02978326|141561046|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.31||0.0106|TWO_SIDED|95.0|-6.0|-0.8||MMRM was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in the HAM-D Total Score at Day 8||-0.8|-6.0|0.0106
71026780|NCT02978326|141561046|SUPERIORITY||LS Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|1.44||0.0321|TWO_SIDED|95.0|-6.0|-0.3||MMRM was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in the HAM-D Total Score at Day 21||-0.3|-6.0|0.0321
71026781|NCT02978326|141561046|SUPERIORITY||LS Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|1.34||0.0027|TWO_SIDED|95.0|-6.7|-1.4||MMRM was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in the HAM-D Total Score at Day 45||-1.4|-6.7|0.0027
71026782|NCT02978326|141561047|SUPERIORITY||Odds Ratio (OR)|1.79||||0.1004|TWO_SIDED|95.0|0.89|3.6||Generalized estimating equations (GEE) for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Response at Day 3||3.60|0.89|0.1004
71026783|NCT02978326|141561047|SUPERIORITY||Odds Ratio (OR)|2.31||||0.0127|TWO_SIDED|95.0|1.2|4.45||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Response at Day 8||4.45|1.20|0.0127
71026784|NCT02978326|141561047|SUPERIORITY||Odds Ratio (OR)|2.63||||0.0049|TWO_SIDED|95.0|1.34|5.16||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Response at Day 15||5.16|1.34|0.0049
71026785|NCT02978326|141561047|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0763|TWO_SIDED|95.0|0.94|3.64||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Response at Day 21||3.64|0.94|0.0763
71026786|NCT02978326|141561047|SUPERIORITY||Odds Ratio (OR)|2.28||||0.0216|TWO_SIDED|95.0|1.13|4.6||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Response at Day 45||4.60|1.13|0.0216
71026787|NCT02978326|141561048|SUPERIORITY||Odds Ratio (OR)|3.89||||0.02|TWO_SIDED|95.0|1.24|12.23||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Remission at Day 3||12.23|1.24|0.0200
71026788|NCT02978326|141561048|SUPERIORITY||Odds Ratio (OR)|1.91||||0.099|TWO_SIDED|95.0|0.89|4.13||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Remission at Day 8||4.13|0.89|0.0990
71026789|NCT02978326|141561048|SUPERIORITY||Odds Ratio (OR)|2.53||||0.011|TWO_SIDED|95.0|1.24|5.17||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Remission at Day 15||5.17|1.24|0.0110
71026790|NCT02978326|141561048|SUPERIORITY||Odds Ratio (OR)|1.58||||0.1982|TWO_SIDED|95.0|0.79|3.19||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Remission at Day 21||3.19|0.79|0.1982
71026791|NCT02978326|141561048|SUPERIORITY||Odds Ratio (OR)|2.52||||0.0091|TWO_SIDED|95.0|1.26|5.03||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Remission at Day 45||5.03|1.26|0.0091
70935795|NCT00786188|141372625|SUPERIORITY_OR_OTHER|||||||0.0644||||||Week 4 severity|Reapeated measures analysis|||||||0.0644
70935796|NCT00786188|141372625|SUPERIORITY_OR_OTHER|||||||0.0364||||||Week 8 severity|Reapeated measures analysis|||||||0.0364
71026792|NCT02978326|141561049|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|2.41||0.3832|TWO_SIDED|95.0|-6.9|2.7||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Core: Change from Baseline in HAM-D Subscale Score at Day 3||2.7|-6.9|0.3832
71026793|NCT02978326|141561049|SUPERIORITY||LS Mean Difference|-5.4|STANDARD_ERROR_OF_MEAN|2.6||0.0415|TWO_SIDED|95.0|-10.5|-0.2||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Core: Change from Baseline in HAM-D Subscale Score at Day 8||-0.2|-10.5|0.0415
71026794|NCT02978326|141561049|SUPERIORITY||LS Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|2.71||0.0606|TWO_SIDED|95.0|-10.5|0.2||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Core: Change from Baseline in HAM-D Subscale Score at Day 15||0.2|-10.5|0.0606
71026795|NCT02978326|141561049|SUPERIORITY||LS Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|2.91||0.0318|TWO_SIDED|95.0|-12.1|-0.6||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Core: Change from Baseline in HAM-D Subscale Score at Day 21||-0.6|-12.1|0.0318
71026796|NCT02978326|141561049|SUPERIORITY||LS Mean Difference|-7.7|STANDARD_ERROR_OF_MEAN|2.69||0.0047|TWO_SIDED|95.0|-13.0|-2.4||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Core: Change from Baseline in HAM-D Subscale Score at Day 45||-2.4|-13.0|0.0047
71026797|NCT02978326|141561049|SUPERIORITY||LS Mean Difference|-7.1|STANDARD_ERROR_OF_MEAN|2.5||0.0053|TWO_SIDED|95.0|-12.0|-2.1||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety: Change from Baseline in HAM-D Subscale Score at Day 3||-2.1|-12.0|0.0053
71026798|NCT02978326|141561049|SUPERIORITY||LS Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|2.76||0.0181|TWO_SIDED|95.0|-12.1|-1.1||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety: Change from Baseline in HAM-D Subscale Score at Day 8||-1.1|-12.1|0.0181
71026799|NCT02978326|141561049|SUPERIORITY||LS Mean Difference|-9.8|STANDARD_ERROR_OF_MEAN|2.82||0.0007|TWO_SIDED|95.0|-15.3|-4.2|||Mixed Model for Repeated Measures|||Anxiety: Change from Baseline in HAM-D Subscale Score at Day 15||-4.2|-15.3|0.0007
71026800|NCT02978326|141561049|OTHER||LS Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|2.79||0.0332|TWO_SIDED|95.0|-11.5|-0.5|||Mixed Model for Repeated Measures|||Anxiety: Change from Baseline in HAM-D Subscale Score at Day 21||-0.5|-11.5|0.0332
71026801|NCT02978326|141561049|OTHER||LS Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|2.8||0.0048|TWO_SIDED|95.0|-13.5|-2.5||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety: Change from Baseline in HAM-D Subscale Score at Day 45||-2.5|-13.5|0.0048
71026802|NCT02978326|141561049|SUPERIORITY||LS Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|3.12||0.184|TWO_SIDED|95.0|-10.3|2.0||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Bech-6: Change from Baseline in HAM-D Subscale Score at Day 3||2.0|-10.3|0.1840
71026803|NCT02978326|141561049|SUPERIORITY||LS Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|3.31||0.0462|TWO_SIDED|95.0|-13.2|-0.1||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Bech-6: Change from Baseline in HAM-D Subscale Score at Day 8||-0.1|-13.2|0.0462
71026804|NCT02978326|141561049|SUPERIORITY||LS Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|3.36||0.015|TWO_SIDED|95.0|-14.9|-1.6||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Bech-6: Change from Baseline in HAM-D Subscale Score at Day 15||-1.6|-14.9|0.0150
71059583|NCT00535405|141626157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.2|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-11.0|-5.5||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANCOVA|ANCOVA mixed model with fixed effects for treatment, baseline LDL-C, study week, treatment by study week interaction, and a random subject effect.||||-5.5|-11.0|<0.001
71059584|NCT00535405|141626158|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|12.62|STANDARD_ERROR_OF_MEAN|3.23|<|0.001||95.0|7.64|20.83||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|"Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.~Generalized Estimating Equations (GEE)"|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||20.83|7.64|<0.001
71059585|NCT00535405|141626158|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|3.83|STANDARD_ERROR_OF_MEAN|0.83|<|0.001||95.0|2.51|5.85||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||5.85|2.51|<0.001
71059586|NCT00535405|141626158|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|3.66|STANDARD_ERROR_OF_MEAN|0.79|<|0.001||95.0|2.39|5.6|||Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||5.60|2.39|<0.001
71109432|NCT04046939|141724284|SUPERIORITY||Mean Difference (Final Values)|-0.0233||||0.0084|TWO_SIDED|95.0|-0.0405|-0.00613||No adjustment for multiple testing of exploratory endpoints was used.|Mixed Models Analysis||Estimate is the difference of the 150 mg BID group from the placebo group in the change absolute basophil count (automated differential) from Baseline to Week 12 (end of primary treatment period). A negative value represents fewer basophils.|The 150 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM) with terms for baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the post-baseline value minus the baseline value.||-0.00613|-0.0405|0.0084
71026805|NCT02978326|141561049|SUPERIORITY||LS Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|3.53||0.0245|TWO_SIDED|95.0|-15.0|-1.0||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Bech-6: Change from Baseline in HAM-D Subscale Score at Day 21||-1.0|-15.0|0.0245
71026806|NCT02978326|141561049|SUPERIORITY||LS Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|3.34||0.0054|TWO_SIDED|95.0|-16.0|-2.8||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Bech-6: Change from Baseline in HAM-D Subscale Score at Day 45||-2.8|-16.0|0.0054
71026807|NCT02978326|141561049|SUPERIORITY||LS Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|2.77||0.0972|TWO_SIDED|95.0|-10.1|0.9||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Meier: Change from Baseline in HAM-D Subscale Score at Day 3||0.9|-10.1|0.0972
71026808|NCT02978326|141561049|SUPERIORITY||LS Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|2.95||0.0155|TWO_SIDED|95.0|-13.1|-1.4||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Meier: Change from Baseline in HAM-D Subscale Score at Day 8||-1.4|-13.1|0.0155
71026809|NCT02978326|141561049|SUPERIORITY||LS Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|3.03||0.0149|TWO_SIDED|95.0|-13.4|-1.5||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Meier: Change from Baseline in HAM-D Subscale Score at Day 15||-1.5|-13.4|0.0149
71026810|NCT02978326|141561049|SUPERIORITY||LS Mean Difference|-7.1|STANDARD_ERROR_OF_MEAN|3.14||0.025|TWO_SIDED|95.0|-13.3|-0.9||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Meier: Change from Baseline in HAM-D Subscale Score at Day 21||-0.9|-13.3|0.0250
71026811|NCT02978326|141561049|SUPERIORITY||LS Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|2.96||0.0017|TWO_SIDED|95.0|-15.3|-3.6||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Meier: Change from Baseline in HAM-D Subscale Score at Day 45||-3.6|-15.3|0.0017
71026812|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.1569|TWO_SIDED|95.0|-0.5|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 3||0.1|-0.5|0.1569
71026813|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0376|TWO_SIDED|95.0|-0.7|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.7|0.0376
71026814|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.1035|TWO_SIDED|95.0|-0.6|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 15||0.1|-0.6|0.1035
71026815|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.0037|TWO_SIDED|95.0|-0.9|-0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 21||-0.2|-0.9|0.0037
71026816|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.0061|TWO_SIDED|95.0|-0.8|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.8|0.0061
71026817|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.16||0.7878|TWO_SIDED|95.0|-0.4|0.3||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 3||0.3|-0.4|0.7878
71026818|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.0498|TWO_SIDED|95.0|-0.6|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.6|0.0498
71026819|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.1719|TWO_SIDED|95.0|-0.5|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 15||0.1|-0.5|0.1719
71026820|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.16||0.0161|TWO_SIDED|95.0|-0.7|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 21||-0.1|-0.7|0.0161
71026821|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.0191|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.6|0.0191
71026822|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.06||0.2537|TWO_SIDED|95.0|-0.2|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Suicide: Change From Baseline in HAM-D Individual Item Score at Day 3||0.1|-0.2|0.2537
71026823|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.0018|TWO_SIDED|95.0|-0.2|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Suicide: Change From Baseline in HAM-D Individual Item Score at Day 8||-0.1|-0.2|0.0018
71026824|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.05||0.2878|TWO_SIDED|95.0|-0.2|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Suicide: Change From Baseline in HAM-D Individual Item Score at Day 15||0.0|-0.2|0.2878
71026825|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.2594|TWO_SIDED|95.0|-0.2|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Suicide: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.2|0.2594
71026826|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.06||0.0086|TWO_SIDED|95.0|-0.3|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Suicide: Change From Baseline in HAM-D Individual Item Score at Day 45||0.0|-0.3|0.0086
71026827|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0424|TWO_SIDED|95.0|-0.6|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 3||0.0|-0.6|0.0424
71026828|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0207|TWO_SIDED|95.0|-0.6|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.6|0.0207
71026829|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.14||0.001|TWO_SIDED|95.0|-0.7|-0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.2|-0.7|0.0010
71026830|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.0871|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 21||0.0|-0.5|0.0871
71059587|NCT00535405|141626159|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|3.05|STANDARD_ERROR_OF_MEAN|0.62|<|0.001||95.0|2.04|4.55||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||4.55|2.04|<0.001
71059588|NCT00535405|141626159|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|1.54|STANDARD_ERROR_OF_MEAN|0.32||0.039||95.0|1.02|2.32||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||2.32|1.02|0.039
71059589|NCT00535405|141626159|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|1.81|STANDARD_ERROR_OF_MEAN|0.43||0.023||95.0|1.14|2.87||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||2.87|1.14|0.023
71026831|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.568|TWO_SIDED|95.0|-0.4|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 45||0.2|-0.4|0.5680
71026832|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0143|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 3||-0.1|-0.6|0.0143
71026833|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0063|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 8||-0.1|-0.6|0.0063
71026834|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0042|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.1|-0.6|0.0042
71059590|NCT00535405|141626160|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|4.47|STANDARD_ERROR_OF_MEAN|1.1|<|0.001||95.0|2.76|7.24||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||7.24|2.76|<0.001
70852236|NCT04145219|141192902|SUPERIORITY||Mean Difference (Final Values)|0.5|||<|0.0001|TWO_SIDED|95.0|0.3|0.7|||Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average rhinoconjunctivitis DSS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.7|0.3|<0.0001
70852237|NCT04145219|141192903|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.0018|TWO_SIDED|95.0|0.2|1.0|||Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average rhinoconjunctivitis DMS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||1.0|0.2|0.0018
70935797|NCT02970318|141372675|OTHER||Hazard Ratio (HR)|0.31|||<|0.0001|TWO_SIDED|95.0|0.2|0.49||Stratified by randomization stratification factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|Log Rank||Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|||0.49|0.20|<0.0001
71026835|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0137|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 21||-0.1|-0.6|0.0137
71026836|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.0099|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.6|0.0099
71026837|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0507|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 3||0.0|-0.5|0.0507
71026838|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0205|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.5|0.0205
71026839|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1409|TWO_SIDED|95.0|-0.5|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 15||0.1|-0.5|0.1409
71026840|NCT02978326|141561050|SUPERIORITY|MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.2021|TWO_SIDED|95.0|-0.5|0.1|||Mixed Model for Repeated Measures|||Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.5|0.2021
71026841|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0117|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.6|0.0117
71059591|NCT00535405|141626160|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|1.77|STANDARD_ERROR_OF_MEAN|0.46||0.026||95.0|1.07|2.94||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||2.94|1.07|0.026
70935798|NCT02970318|141372676|OTHER||Hazard Ratio (HR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.2|0.38||Stratified by randomization stratification factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|Log Rank||Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|||0.38|0.20|<0.0001
70935799|NCT02970318|141372677|OTHER||Risk Difference (RD)|5.8||||0.2248|TWO_SIDED|95.0|-3.3|14.9|||Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel test with adjustment for randomization stratification factors as recorded in IXRS.|Risk difference (% Arm A - Arm B) based on Cochran-Mantel-Haenszel test with adjustment for randomization stratification factors as recorded in IXRS.|||14.9|-3.3|0.2248
71059592|NCT00535405|141626160|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|2.27|STANDARD_ERROR_OF_MEAN|0.71||0.017||95.0|1.23|4.18||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||4.18|1.23|0.017
71059593|NCT00535405|141626161|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|7.6|STANDARD_ERROR_OF_MEAN|2.2|<|0.001||95.0|4.31|13.42||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||13.42|4.31|<0.001
71059594|NCT00535405|141626161|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|2.95|STANDARD_ERROR_OF_MEAN|0.69|<|0.001||95.0|1.86|4.67||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||4.67|1.86|<0.001
71059595|NCT00535405|141626161|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|2.15|STANDARD_ERROR_OF_MEAN|0.46|<|0.001||95.0|1.42|3.27||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||3.27|1.42|<0.001
71026842|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.5511|TWO_SIDED|95.0|-0.4|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 3||0.2|-0.4|0.5511
71026843|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.4949|TWO_SIDED|95.0|-0.5|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 8||0.2|-0.5|0.4949
71026844|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0203|TWO_SIDED|95.0|-0.7|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.1|-0.7|0.0203
71026845|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.2076|TWO_SIDED|95.0|-0.6|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.6|0.2076
71026846|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.0362|TWO_SIDED|95.0|-0.8|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 45||0.0|-0.8|0.0362
71026847|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.3589|TWO_SIDED|95.0|-0.1|0.3||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Retardation: Change From Baseline in HAM-D Individual Item Score at Day 3||0.3|-0.1|0.3589
71026848|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.6991|TWO_SIDED|95.0|-0.2|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Retardation: Change From Baseline in HAM-D Individual Item Score at Day 8||0.2|-0.2|0.6991
71059596|NCT00535405|141626162|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|6.02|STANDARD_ERROR_OF_MEAN|2.45|<|0.001||95.0|2.71|13.38||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||13.38|2.71|<0.001
70935800|NCT02970318|141372678|OTHER||Risk Difference (RD)|-1.3||||0.734|TWO_SIDED|95.0|-9.6|7.0|||Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel test with adjustment for randomization stratification factors as recorded in IXRS.|Risk difference (% Arm A - Arm B) based on Cochran-Mantel-Haenszel test with adjustment for randomization stratification factors as recorded in IXRS.|||7.0|-9.6|0.7340
71059597|NCT00535405|141626162|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|1.67|STANDARD_ERROR_OF_MEAN|0.47||0.069||95.0|0.96|2.6||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||2.60|0.96|0.069
71059598|NCT00535405|141626162|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|1.78|STANDARD_ERROR_OF_MEAN|0.44||0.039|TWO_SIDED|95.0|1.1|2.9||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||2.90|1.10|0.039
70941724|NCT04748445|141383935|OTHER||Slope|0.0005153|STANDARD_ERROR_OF_MEAN|1.523||0.7356|TWO_SIDED|90.0|-0.002008|0.003038|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.003038|-0.002008|0.7356
71026849|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.9655|TWO_SIDED|95.0|-0.2|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Retardation: Change From Baseline in HAM-D Individual Item Score at Day 15||0.2|-0.2|0.9655
71026850|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8699|TWO_SIDED|95.0|-0.2|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Retardation: Change From Baseline in HAM-D Individual Item Score at Day 21||0.2|-0.2|0.8699
71026851|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.3715|TWO_SIDED|95.0|-0.3|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Retardation: Change From Baseline in HAM-D Individual Item Score at Day 45||0.1|-0.3|0.3715
71026852|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.067|TWO_SIDED|95.0|-0.4|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Agitation: Change From Baseline in HAM-D Individual Item Score at Day 3||0.0|-0.4|0.0670
71026853|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.11||0.0104|TWO_SIDED|95.0|-0.5|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Agitation: Change From Baseline in HAM-D Individual Item Score at Day 8||-0.1|-0.5|0.0104
71026854|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0122|TWO_SIDED|95.0|-0.5|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Agitation: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.1|-0.5|0.0122
71026855|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.3157|TWO_SIDED|95.0|-0.3|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Agitation: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.3|0.3157
71026856|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.11||0.0077|TWO_SIDED|95.0|-0.5|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Agitation: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.5|0.0077
71026857|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.16||0.0078|TWO_SIDED|95.0|-0.8|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 3||-0.1|-0.8|0.0078
71026858|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0372|TWO_SIDED|95.0|-0.7|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.7|0.0372
71026859|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0244|TWO_SIDED|95.0|-0.7|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.1|-0.7|0.0244
71026860|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.0993|TWO_SIDED|95.0|-0.6|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.6|0.0993
71026861|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0185|TWO_SIDED|95.0|-0.7|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.7|0.0185
71059599|NCT03091179|141626177|EQUIVALENCE|P value was calculated using the means and standard deviations for each of the patient characteristics.||||||0.006|||||||t-test, 2 sided|||||||0.006
71077975|NCT00703326|141664447|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85||||0.033|TWO_SIDED|95.0|0.73|0.99|||Stratified Log Rank (SLR)|SLR used Interactive Web Response System (IWRS) factors: prior taxane therapy, visceral metastasis, hormone receptor status and geographical regions.|HR with 95% confidence interval (CI) was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors.|||0.99|0.73|0.033
71026862|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.2471|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 3||0.1|-0.4|0.2471
71026863|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1076|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.5|0.1076
71026864|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.2782|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 15||0.1|-0.4|0.2782
71026865|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.4646|TWO_SIDED|95.0|-0.4|0.2|||Mixed Model for Repeated Measures|||Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 21||0.2|-0.4|0.4646
70935801|NCT02970318|141372679|OTHER||Hazard Ratio (HR)|0.69||||0.0783|TWO_SIDED|95.0|0.46|1.04|||Log Rank|Log-Rank Analysis stratified by factors recorded in IXRS data: presence of deletion 17 p (yes / no), ECOG (0-1/2), # of prior therapies (1-3/4+).|Cox proportional hazard analysis stratified (Arm A vs. Arm B) by factors recorded in IXRS data including presence of deletion 17 p (yes / no), ECOG (0-1/2), # of prior therapies (1-3/4+).|Analysis stratified by factors recorded in IXRS data including presence of deletion 17 p (yes / no), ECOG (0-1/2), # of prior therapies (1-3/4+).||1.04|0.46|0.0783
71026866|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.16|TWO_SIDED|95.0|-0.5|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 45||0.1|-0.5|0.1600
71026867|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.0474|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 3||0.0|-0.5|0.0474
71026868|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.0446|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.5|0.0446
71026869|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0093|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.1|-0.6|0.0093
71026870|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.2998|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.4|0.2998
71026871|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.0545|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 45||0.0|-0.5|0.0545
71026872|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.2177|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 3||0.1|-0.4|0.2177
71026873|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.23|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 8||0.1|-0.4|0.2300
71026874|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.12||0.0001|TWO_SIDED|95.0|-0.7|-0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.2|-0.7|0.0001
71026875|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0151|TWO_SIDED|95.0|-0.5|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 21||-0.1|-0.5|0.0151
71026876|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0502|TWO_SIDED|95.0|-0.5|0.0|||Mixed Model for Repeated Measures|||General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 45||0.0|-0.5|0.0502
71077976|NCT00703326|141664448|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.33||||0.027|TWO_SIDED|95.0|1.03|1.71|||Stratified Cochran-Mantel-Haenszel(SCMH)|SCMH used Interactive Web Response System (IWRS) factors: prior taxane therapy, visceral metastasis, hormone receptor status and geographical regions.|Stratified odds ratio was calculated considering the IWRS stratification factors.|||1.71|1.03|0.027
71026877|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.3659|TWO_SIDED|95.0|-0.3|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 3||0.1|-0.3|0.3659
71026878|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.6003|TWO_SIDED|95.0|-0.3|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 8||0.2|-0.3|0.6003
71026879|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.0785|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 15||0.0|-0.5|0.0785
71026880|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.3668|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.4|0.3668
71026881|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1827|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 45||0.1|-0.4|0.1827
71026882|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.1327|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 3||0.1|-0.4|0.1327
71026883|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0993|TWO_SIDED|95.0|-0.4|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.4|0.0993
71026884|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.11||0.0002|TWO_SIDED|95.0|-0.6|-0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.2|-0.6|0.0002
71026885|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0056|TWO_SIDED|95.0|-0.5|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 21||-0.1|-0.5|0.0056
71026886|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.11||0.0122|TWO_SIDED|95.0|-0.5|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.5|0.0122
71026887|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1305|TWO_SIDED|95.0|-0.3|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 3||0.0|-0.3|0.1305
71026888|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.6638|TWO_SIDED|95.0|-0.2|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 8||0.1|-0.2|0.6638
71026889|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.4341|TWO_SIDED|95.0|-0.2|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 15||0.1|-0.2|0.4341
71026890|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.9085|TWO_SIDED|95.0|-0.1|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.1|0.9085
71059600|NCT03282916|141626203|SUPERIORITY|Linear mixed-effects models (LMM) were used to assess the treatment effects on the outcome with change score from baseline as the dependent variable and treatment, study time point, and their interaction as predictors, adjusting for baseline value of the outcome.|Mean Difference (Final Values)|3.91|||<|0.05|TWO_SIDED|95.0|1.03|6.8||Not adjusted for multiple comparisons|Mixed Models Analysis|Adjusting for baseline value of ADAS-Cog11||"Null hypothesis: there is no difference in change in ADAS-Cog11 between valacyclovir and placebo treatment.~A sample size of 130 participants (65 per arm) was originally projected to detect Cohen's d of 0.50 with 80% power at 5% significance level. Recruitment target was reduced to 120 participants due to pandemic-related recruitment delays and required study completion within the extended funding timeline. For n=120, the minimum detectable effect size increased slightly to Cohen's d of 0.52."||6.80|1.03|<0.05
71059601|NCT01328184|141626207|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as Microgynon plus empa divided by Microgynon|Geometric Mean Ratio|102.82|STANDARD_DEVIATION|9.0|||TWO_SIDED|90.0|97.58|108.35|||ANOVA|Based on ANOVA with fixed term for treatment and random term for subject.|Standard deviation is actually the geometric coefficient of variation (gCV)|No formal testing, investigation of relative bioavailability.||108.35|97.58|
71059602|NCT01328184|141626208|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as Microgynon plus empa divided by Microgynon|Geometric Mean Ratio|101.94|STANDARD_DEVIATION|5.9|||TWO_SIDED|90.0|98.54|105.47|||ANOVA|Based on ANOVA with fixed term for treatment and random term for subject.|Standard deviation is actually the geometric coefficient of variation (gCV)|No formal testing, investigation of relative bioavailability.||105.47|98.54|
71059603|NCT01328184|141626209|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as Microgynon plus empa divided by Microgynon|Geometric Mean Ratio|99.22|STANDARD_DEVIATION|10.4|||TWO_SIDED|90.0|93.4|105.39|||ANOVA|Based on ANOVA with fixed term for treatment and random term for subject.|Standard deviation is actually the geometric coefficient of variation (gCV).|No formal testing, investigation of relative bioavailability.||105.39|93.40|
71059604|NCT01328184|141626210|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as Microgynon plus empa divided by Microgynon|Geometric Mean Ratio|105.81|STANDARD_DEVIATION|10.7|||TWO_SIDED|90.0|99.47|112.55|||ANOVA|Based on ANOVA with fixed term for treatment and random term for subject.|Standard deviation is actually the geometric coefficient of variation (gCV)|No formal testing, investigation of relative bioavailability.||112.55|99.47|
71059605|NCT01959295|141626225|SUPERIORITY|||||||0.5086|||||||Mantel Haenszel|||The superiority of ASP2151 200mg to ASP2151 placebo was assessed by Mantel-Haenszel method, adjusted by disease type (labial/facial herpes and recurrent genital herpes) .||||0.5086
71059606|NCT04848480|141626268|NON_INFERIORITY|Non-inferiority was considered confirmed if the estimated treatment difference was below 0.3%.|Treatment difference|0.05||||0.0065|TWO_SIDED|95.0|-0.13|0.23|||ANCOVA|||Change from baseline in HbA1c after 26 weeks was analysed using ANCOVA model with treatment, region, HbA1c group at screening and pre-trial basal insulin treatment as fixed factors, and baseline response as covariate.||0.23|-0.13|0.0065
71026891|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.182|TWO_SIDED|95.0|-0.3|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 45||0.1|-0.3|0.1820
71026892|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.1593|TWO_SIDED|95.0|-0.1|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insight: Change From Baseline in HAM-D Individual Item Score at Day 3||0.0|-0.1|0.1593
71059607|NCT02366689|141626329|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.04
71059608|NCT02366689|141626330|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||< 0.001
71059609|NCT02366689|141626331|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
71059610|NCT02366689|141626332|SUPERIORITY_OR_OTHER|||||||0.432|TWO_SIDED||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.432
71059611|NCT02366689|141626333|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
71059612|NCT02366689|141626334|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
70935802|NCT02970318|141372680|OTHER||Hazard Ratio (HR)|0.33|||<|0.0001|TWO_SIDED|95.0|0.19|0.59||Log Rank Test stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|Log Rank||Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|||0.59|0.19|<0.0001
71059613|NCT03283566|141626336|EQUIVALENCE|Assuming a 20-30% difference in outcome (CP/G quotient) between study arms, which is equivalent to 0.08-0.12 CP/G difference and a 0.07 standard deviation, a sample size of 6 subjects (1:1 randomization) will detect a CP/G difference of at least 0.12, assuming 80% power, with a 0.05 significance level.||||||0.739|||||||ANOVA|||||||0.739
71059614|NCT03718832|141626338|SUPERIORITY||Mean Difference (Net)|-0.0333487|STANDARD_ERROR_OF_MEAN|0.1943638||0.8638688|TWO_SIDED|95.0|-0.415628|0.3489306||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.3489306|-0.415628|0.8638688
71059615|NCT03718832|141626338|SUPERIORITY||Mean Difference (Net)|-0.0066385|STANDARD_ERROR_OF_MEAN|0.1853917||0.9714571|TWO_SIDED|95.0|-0.371329|0.358052||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.358052|-0.371329|0.9714571
71059616|NCT03718832|141626339|SUPERIORITY||Mean Difference (Net)|0.1409446|STANDARD_ERROR_OF_MEAN|0.2106711||0.5039565|TWO_SIDED|95.0|-0.2735162|0.5554053||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.5554053|-0.2735162|0.5039565
70941725|NCT04748445|141383935|OTHER||Slope|-0.00133|STANDARD_ERROR_OF_MEAN|6.782||0.0522|TWO_SIDED|90.0|-0.002453|-0.0002057|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 02 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0002057|-0.002453|0.0522
71026893|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.6555|TWO_SIDED|95.0|-0.1|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insight: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.1|0.6555
71026894|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.03||0.017|TWO_SIDED|95.0|-0.1|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insight: Change From Baseline in HAM-D Individual Item Score at Day 15||0.0|-0.1|0.0170
71026895|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.03||0.0188|TWO_SIDED|95.0|-0.1|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insight: Change From Baseline in HAM-D Individual Item Score at Day 21||0.0|-0.1|0.0188
71026896|NCT02978326|141561050|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.05||0.0726|TWO_SIDED|95.0|-0.2|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insight: Change From Baseline in HAM-D Individual Item Score at Day 45||0.0|-0.2|0.0726
71026897|NCT02978326|141561051|SUPERIORITY||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.72||0.0791|TWO_SIDED|95.0|-6.5|0.4||MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in MADRS Total Score at Day 3||0.4|-6.5|0.0791
71026898|NCT02978326|141561051|SUPERIORITY||LS Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.86||0.0322|TWO_SIDED|1.86|-7.7|-0.3||MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in MADRS Total Score at Day 8||-0.3|-7.7|0.0322
71026899|NCT02978326|141561051|SUPERIORITY||LS Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|1.91||0.018|TWO_SIDED|95.0|-8.3|-0.8||MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in MADRS Total Score at Day 15||-0.8|-8.3|0.0180
71026900|NCT02978326|141561051|SUPERIORITY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|1.92||0.0271|TWO_SIDED|95.0|-8.1|-0.5||MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in MADRS Total Score at 21||-0.5|-8.1|0.0271
71026901|NCT02978326|141561051|SUPERIORITY||LS Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|1.82||0.0018|TWO_SIDED|95.0|-9.4|-2.2||MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in MADRS Total Score at 45||-2.2|-9.4|0.0018
71026902|NCT02978326|141561052|SUPERIORITY||Odds Ratio (OR)|1.4||||0.3372|TWO_SIDED|95.0|0.7|2.81||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With CGI-I Response at Day 3||2.81|0.70|0.3372
71026903|NCT02978326|141561052|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0935|TWO_SIDED|95.0|0.91|3.47||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With CGI-I Response at Day 8||3.47|0.91|0.0935
71026904|NCT02978326|141561052|SUPERIORITY||Odds Ratio (OR)|2.16||||0.0276|TWO_SIDED|95.0|1.09|4.28||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With CGI-I Response at Day 15||4.28|1.09|0.0276
71026905|NCT02978326|141561052|SUPERIORITY||Odds Ratio (OR)|1.79||||0.092|TWO_SIDED|95.0|0.91|3.54||Generalized estimating equations for binary response model was used for estimation with factors for treatment: Baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With CGI-I Response at Day 21||3.54|0.91|0.0920
71026906|NCT02978326|141561052|SUPERIORITY||Odds Ratio (OR)|1.76||||0.1109|TWO_SIDED|95.0|0.88|3.51||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With CGI-I Response at Day 45||3.51|0.88|0.1109
71026907|NCT02978326|141561053|SUPERIORITY||LS Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|1.29||0.0169|TWO_SIDED|95.0|-5.7|-0.6||MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in HAM-A Total Score at Day 3||-0.6|-5.7|0.0169
71026908|NCT02978326|141561053|SUPERIORITY||LS Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|1.32||0.001|TWO_SIDED|95.0|-7.0|-1.8||MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in HAM-A Total Score at Day 8||-1.8|-7.0|0.0010
71026909|NCT02978326|141561053|SUPERIORITY||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|1.41||0.0063|TWO_SIDED|95.0|-6.7|-1.1||MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in HAM-A Total Score at Day 15||-1.1|-6.7|0.0063
70852238|NCT04145219|141192904|SUPERIORITY||Mean Difference (Final Values)|0.2|||<|0.0001|TWO_SIDED|95.0|0.1|0.2||This endpoint was controlled for multiplicity using hierarchical testing|Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The overall PRQLQ score was analysed using a linear mixed effect (LME) model. The model includes the overall PRQLQ score as response variable, treatment and cohort as fixed factors, the baseline overall PRQLQ score as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.2|0.1|<0.0001
70935803|NCT02970318|141372681|OTHER||Hazard Ratio (HR)|0.23|||<|0.0001|TWO_SIDED|95.0|0.16|0.33||Log Rank Test stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|Log Rank||Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|||0.33|0.16|<0.0001
70935804|NCT02970318|141372682|OTHER||Hazard Ratio (HR)|0.29|||<|0.0001|TWO_SIDED|95.0|0.21|0.4||Log Rank Test stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|Log Rank||Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|||0.40|0.21|<0.0001
71026910|NCT02978326|141561053|SUPERIORITY||LS Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|1.37||0.0119|TWO_SIDED|95.0|-6.2|-0.8||MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in HAM-A Total Score at Day 21||-0.8|-6.2|0.0119
71026911|NCT02978326|141561053|SUPERIORITY||LS Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.28||0.0002|TWO_SIDED|95.0|-7.5|-2.4||MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in HAM-A Total Score at Day 45||-2.4|-7.5|0.0002
71026912|NCT02978326|141561054|SUPERIORITY||Odds Ratio (OR)|1.75||||0.1145|TWO_SIDED|95.0|0.87|3.53||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Response at Day 3||3.53|0.87|0.1145
71026913|NCT02978326|141561054|SUPERIORITY||Odds Ratio (OR)|1.71||||0.1069|TWO_SIDED|95.0|0.89|3.3||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Response at Day 8||3.30|0.89|0.1069
71026914|NCT02978326|141561054|SUPERIORITY||Odds Ratio (OR)|2.67||||0.0045|TWO_SIDED|95.0|1.36|5.27||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Response at Day 15||5.27|1.36|0.0045
71026915|NCT02978326|141561054|SUPERIORITY||Odds Ratio (OR)|2.01||||0.0421|TWO_SIDED|95.0|1.03|3.93||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Response at Day 21||3.93|1.03|0.0421
71026916|NCT02978326|141561054|SUPERIORITY||Odds Ratio (OR)|1.99||||0.0541|TWO_SIDED|95.0|0.99|4.03||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Response at Day 45||4.03|0.99|0.0541
71026917|NCT02978326|141561055|SUPERIORITY||Odds Ratio (OR)|2.84||||0.0326|TWO_SIDED|95.0|1.09|7.38||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Remission at Day 3||7.38|1.09|0.0326
71026918|NCT02978326|141561055|SUPERIORITY||Odds Ratio (OR)|1.38||||0.3749|TWO_SIDED|95.0|0.68|2.79||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Remission at Day 8||2.79|0.68|0.3749
71026919|NCT02978326|141561055|SUPERIORITY||Odds Ratio (OR)|2.49||||0.0087|TWO_SIDED|95.0|1.26|4.92||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Remission at Day 15||4.92|1.26|0.0087
70935805|NCT00824408|141372683|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.045||||0.003|TWO_SIDED|95.0|1.271|3.292|||Log Rank|||Hazard ratio and 95% confidence interval (CI) from Cox proportional-hazards regression model, stratified by histology (Nonsquamous vs. NOS). P-value from log-rank test stratified by histology (one-sided for volasertib 300 mg + pemetrexed 500 mg/m2 vs. pemetrexed 500 mg; two-sided for volasertib 300 mg vs. pemetrexed 500 mg/m2).||3.292|1.271|0.0030
70935806|NCT00824408|141372683|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.141||||0.2804|TWO_SIDED|95.0|0.735|1.771|||Log Rank|||Hazard ratio and 95% CI from Cox proportional-hazards regression model, stratified by histology (Nonsquamous vs. NOS). P-value from log-rank test stratified by histology (one-sided for volasertib 300 mg + pemetrexed 500 mg/m2 vs. pemetrexed 500 mg/m2; two-sided for volasertib 300 mg vs. pemetrexed 500 mg/m2).||1.771|0.735|0.2804
70935807|NCT00824408|141372684|SUPERIORITY_OR_OTHER||||||>|0.9999|||||||Fisher Exact|||||||>0.9999
71026920|NCT02978326|141561055|SUPERIORITY||Odds Ratio (OR)|2.18||||0.0257|TWO_SIDED|95.0|1.1|4.31||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Remission at Day 21||4.31|1.10|0.0257
71026921|NCT02978326|141561055|SUPERIORITY||Odds Ratio (OR)|2.08||||0.0339|TWO_SIDED|95.0|1.06|4.09||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Remission at Day 45||4.09|1.06|0.0339
71026922|NCT02566135|141561070|OTHER||Risk Ratio (RR)|1.4628||||0.5033|TWO_SIDED|95.0|0.6401|3.3428|||Chi-squared, Corrected|||Chi square test was applied to see weather there is a statistical significant difference between group I and group C for attempt for supraglottic airway insertion.||3.3428|0.6401|0.5033
71026923|NCT02566135|141561071|OTHER||Risk Ratio (RR)|0.8972|||>|0.05|TWO_SIDED|95.0|0.4858|1.6569|||Chi-squared, Corrected|||We had applied chi square to see the statistical significant difference between group I and group C for number of attempt for ventilating bougie insertion.||1.6569|0.4858|>0.05
71026924|NCT02566135|141561072|OTHER||||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
71059617|NCT03718832|141626339|SUPERIORITY||Mean Difference (Net)|0.1213915|STANDARD_ERROR_OF_MEAN|0.2126328||0.5684854|TWO_SIDED|95.0|-0.2970052|0.5397882||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.5397882|-0.2970052|0.5684854
71026925|NCT02566135|141561073|OTHER|||||||0.44|||||||t-test, 2 sided|||Heart rate beats per minute measured at base line among the group I and group C.||||0.44
71026926|NCT02566135|141561073|OTHER|||||||0.58|||||||t-test, 2 sided|||Heart rate beats per minute is measured following Dexmedetomidine injection among the group I and group C.||||0.58
71026927|NCT02566135|141561073|OTHER|||||||0.16|||||||t-test, 2 sided|||Heart rate beats per minute measured following induction of anaesthesia among the group I and group C.||||0.16
71026928|NCT02566135|141561073|OTHER|||||||0.22|||||||t-test, 2 sided|||Heart rate beats per minute measured following supraglottic airway insertion among the group I and group C.||||0.22
71026929|NCT02566135|141561073|OTHER|||||||0.059|||||||t-test, 2 sided|||Heart rate beats per minute measured following ventilating bougie insertion among the group I and group C.||||0.059
71026930|NCT02566135|141561073|OTHER||||||>|0.33|||||||t-test, 2 sided|||Heart rate beats per minute measured at endotracheal intubation among the group I and group C.||||>0.33
71026931|NCT02566135|141561073|OTHER|||||||0.63|||||||t-test, 2 sided|||Heart rate beats per minute measured after 3 minute of ETT insertion among the group I and group C.||||0.63
71109433|NCT04046939|141724284|SUPERIORITY||Mean Difference (Final Values)|-0.0206||||0.0237|TWO_SIDED|95.0|-0.0384|-0.00281||No adjustment for multiple testing of exploratory endpoints was used.|Mixed Models Analysis||Estimate is the difference of the 75 mg BID group from the placebo group in the change absolute basophil count (automated differential) from Baseline to Week 12 (end of primary treatment period). A negative value represents fewer basophils.|The 75 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM) with terms for baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the post-baseline value minus the baseline value.||-0.00281|-0.0384|0.0237
71059618|NCT03718832|141626340|SUPERIORITY||Mean Difference (Net)|-13.26835|STANDARD_ERROR_OF_MEAN|10.90353||0.2247426|TWO_SIDED|95.0|-34.73804|8.201347||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||8.201347|-34.73804|0.2247426
71026932|NCT02566135|141561073|OTHER|||||||0.29|||||||t-test, 2 sided|||Heart rate beats per minute measured after 5 minute of ETT insertion among the group I and group C.||||0.29
71026933|NCT02566135|141561073|OTHER|||||||0.18|||||||t-test, 2 sided|||Heart rate beats per minute measured after 7 minute of ETT insertion among the group I and group C.||||0.18
71026934|NCT02566135|141561073|OTHER|||||||0.98|||||||t-test, 2 sided|||Heart rate beats per minute measured after 10 minute of ETT insertion among the group I and group C.||||0.98
71026935|NCT02566135|141561073|OTHER|||||||0.49|||||||t-test, 2 sided|||Heart rate beats per minute measured after 15 minute of ETT insertion among the group I and group C.||||0.49
71026936|NCT02566135|141561074|OTHER|||||||0.24|||||||t-test, 2 sided|||Systolic blood pressure measured and compared at base line between group I and group C.||||0.24
71026937|NCT02566135|141561074|OTHER|||||||0.11|||||||t-test, 2 sided|||Systolic blood pressure measured and compared following Dexmedetomidine injection between group I and group C.||||0.11
71026938|NCT02566135|141561074|OTHER|||||||0.07|||||||t-test, 2 sided|||Systolic blood pressure measured and compared following induction os anaesthesia between group I and group C.||||0.07
71026939|NCT02566135|141561074|OTHER|||||||0.85|||||||t-test, 2 sided|||Systolic blood pressure measured and compared following supraglottic airway insertion between group I and group C.||||0.85
71026940|NCT02566135|141561074|OTHER|||||||0.055|||||||t-test, 2 sided|||Systolic blood pressure measured and compared following ventilating bougie insertion between group I and group C.||||0.055
71026941|NCT02566135|141561074|OTHER|||||||0.71|||||||t-test, 2 sided|||Systolic blood pressure measured and compared at ETT insertion time between group I and group C.||||0.71
71026942|NCT02566135|141561074|OTHER|||||||0.2|||||||t-test, 2 sided|||Systolic blood pressure measured and compared 3 minutes after ETT insertion between group I and group C.||||0.20
71059619|NCT03718832|141626340|SUPERIORITY||Mean Difference (Net)|-12.20164|STANDARD_ERROR_OF_MEAN|11.25555||0.2794015|TWO_SIDED|95.0|-34.37119|9.9679||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||9.9679|-34.37119|0.2794015
71059620|NCT03718832|141626340|SUPERIORITY||Mean Difference (Net)|13.12548|STANDARD_ERROR_OF_MEAN|9.550462||0.1708328|TWO_SIDED|95.0|-5.703702|31.95466||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||31.95466|-5.703702|0.1708328
71059621|NCT03718832|141626340|SUPERIORITY||Mean Difference (Net)|11.47577|STANDARD_ERROR_OF_MEAN|10.59479||0.2801138|TWO_SIDED|95.0|-9.422762|32.3743||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||32.3743|-9.422762|0.2801138
71059622|NCT03718832|141626341|SUPERIORITY||Mean Difference (Net)|-8.135585|STANDARD_ERROR_OF_MEAN|6.325031||0.1991028|TWO_SIDED|95.0|-20.57023|4.299061||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||4.299061|-20.57023|0.1991028
71059623|NCT03718832|141626341|SUPERIORITY||Mean Difference (Net)|3.493798|STANDARD_ERROR_OF_MEAN|1.761916||0.0480884|TWO_SIDED|95.0|0.0295297|6.958066||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||6.958066|0.0295297|0.0480884
71059624|NCT03718832|141626341|SUPERIORITY||Mean Difference (Net)|-9.681804|STANDARD_ERROR_OF_MEAN|6.34136||0.1276817|TWO_SIDED|95.0|-22.15188|2.788269||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||2.788269|-22.15188|0.1276817
71117636|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
71026943|NCT02566135|141561074|OTHER|||||||0.86|||||||t-test, 2 sided|||Systolic blood pressure measured and compared 5 minutes after ETT insertion between group I and group C.||||0.86
71026944|NCT02566135|141561074|OTHER|||||||0.68|||||||t-test, 2 sided|||Systolic blood pressure measured and compared 7 minutes after ETT insertion between group I and group C.||||0.68
71026945|NCT02566135|141561074|OTHER|||||||0.98|||||||t-test, 2 sided|||Systolic blood pressure measured and compared 10 minutes after ETT insertion between group I and group C.||||0.98
71026946|NCT02566135|141561074|OTHER|||||||0.49|||||||t-test, 2 sided|||Systolic blood pressure measured and compared 15 minutes after ETT insertion between group I and group C.||||0.49
71026947|NCT02566135|141561075|OTHER|||||||0.34|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared at base line between group I and group C.||||0.34
71026948|NCT02566135|141561075|OTHER|||||||0.27|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared following Dexmedetomidine injection between group I and group C.||||0.27
71026949|NCT02566135|141561075|OTHER|||||||0.22|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared following induction of anaesrthesia between group I and group C.||||0.22
71026950|NCT02566135|141561075|OTHER|||||||0.96|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared following supraglottic airway insertion between group I and group C.||||0.96
71026951|NCT02566135|141561075|OTHER|||||||0.71|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared following ventilating bougie insertion between group I and group C.||||0.71
71026952|NCT02566135|141561075|OTHER|||||||0.55|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared the time of endotracheal tube insertion between group I and group C.||||0.55
71026953|NCT02566135|141561075|OTHER|||||||0.49|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared 3 minutes after endotracheal tube insertion between group I and group C.||||0.49
71026954|NCT02566135|141561075|OTHER|||||||0.49|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared 5 minutes after endotracheal tube insertion between group I and group C.||||0.49
71026955|NCT02566135|141561075|OTHER|||||||0.76|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared 7 minutes after endotracheal tube insertion between group I and group C.||||0.76
71026956|NCT02566135|141561075|OTHER|||||||0.69|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared 10 minutes after endotracheal tube insertion between group I and group C.||||0.69
71026957|NCT02566135|141561075|OTHER|||||||0.81|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared 15 minutes after endotracheal tube insertion between group I and group C.||||0.81
71026958|NCT02566135|141561076|OTHER||||||<|0.0001|||||||t-test, 2 sided|||We had compared time of insertion for supraglottic airway between group I and group C.||||<0.0001
71026959|NCT02566135|141561077|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71026960|NCT01937364|141561085|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.4||||0.0334|TWO_SIDED|90.0|-0.7275|-0.0206||One-sided p-value|z-statistic with pooled estimate||RD = Baclofen - Placebo|||-0.0206|-0.7275|0.0334
71026961|NCT01937364|141561086|SUPERIORITY_OR_OTHER|||||||0.3744|||||||Mixed Models Analysis|||Baclofen - Placebo; 24 hours||||0.3744
71026962|NCT01937364|141561086|SUPERIORITY_OR_OTHER|||||||0.7616|||||||Mixed Models Analysis|||Baclofen - Placebo; 48 hours||||0.7616
71026963|NCT01937364|141561086|SUPERIORITY_OR_OTHER|||||||0.1393|||||||Mixed Models Analysis|||Baclofen - Placebo; 72 hours||||0.1393
71059625|NCT03718832|141626341|SUPERIORITY||Mean Difference (Net)|1.658257|STANDARD_ERROR_OF_MEAN|1.706497||0.3318554|TWO_SIDED|95.0|-1.698022|5.014535||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||5.014535|-1.698022|0.3318554
71059626|NCT03718832|141626342|SUPERIORITY||Mean Difference (Net)|-0.8749266|STANDARD_ERROR_OF_MEAN|0.9355095||0.3502313|TWO_SIDED|95.0|-2.714084|0.9642311||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.9642311|-2.714084|0.3502313
71026964|NCT01937364|141561087|SUPERIORITY_OR_OTHER|||||||0.33||||||Baclofen - Placebo; Peak Ativan 1mg PO equivalent dose|Wilcoxon (Mann-Whitney)|||||||0.33
71059627|NCT03718832|141626342|SUPERIORITY||Mean Difference (Net)|0.5608222|STANDARD_ERROR_OF_MEAN|0.2708671||0.0390797|TWO_SIDED|95.0|0.0282451|1.093399||Adjusted mean difference for full controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||1.093399|0.0282451|0.0390797
71026965|NCT01937364|141561087|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||Baclofen - Placebo; Total Ativan 1mg PO equivalent dose||||0.80
71026966|NCT02974153|141561095|SUPERIORITY||Mean Difference (Final Values)|-2.6|STANDARD_DEVIATION|6.15|<|0.0001|TWO_SIDED|95.0|-3.45|-1.74|||ANCOVA|||||-1.74|-3.45|<0.0001
71026967|NCT02974153|141561095|SUPERIORITY||Mean Difference (Final Values)|-2.03|STANDARD_DEVIATION|6.15|<|0.0001|TWO_SIDED|95.0|-2.88|-1.18|||ANCOVA|||||-1.18|-2.88|<0.0001
71026968|NCT02974153|141561096|SUPERIORITY||Mean Difference (Final Values)|18.1|||<|0.0001|TWO_SIDED|95.0|12.0|24.3|||Cochran-Mantel-Haenszel|||||24.3|12.0|<0.0001
71026969|NCT02974153|141561096|SUPERIORITY||Mean Difference (Final Values)|11.7||||0.0001|TWO_SIDED|95.0|5.8|17.5|||Cochran-Mantel-Haenszel|||||17.5|5.8|0.0001
71026970|NCT02974153|141561097|SUPERIORITY||Mean Difference (Final Values)|21.3|||<|0.0001|TWO_SIDED|95.0|15.0|27.6|||Cochran-Mantel-Haenszel|||||27.6|15.0|<0.0001
71026971|NCT02974153|141561097|SUPERIORITY||Mean Difference (Final Values)|15.3|||<|0.0001|TWO_SIDED|95.0|9.3|21.4|||Cochran-Mantel-Haenszel|||||21.4|9.3|<0.0001
71026972|NCT02974153|141561098|SUPERIORITY||Mean Difference (Final Values)|22.1|||<|0.0001|TWO_SIDED|95.0|14.9|29.2|||Cochran-Mantel-Haenszel|||||29.2|14.9|<0.0001
71026973|NCT02974153|141561098|SUPERIORITY||Mean Difference (Final Values)|18.2|||<|0.0001|TWO_SIDED|95.0|11.1|25.4|||Cochran-Mantel-Haenszel|||||25.4|11.1|<0.0001
71026974|NCT02974153|141561099|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71059628|NCT03718832|141626342|SUPERIORITY||Mean Difference (Net)|-1.450197|STANDARD_ERROR_OF_MEAN|0.9508997||0.1281032|TWO_SIDED|95.0|-3.320109|0.419716||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.419716|-3.320109|0.1281032
71026975|NCT02974153|141561099|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71026976|NCT02974153|141561100|SUPERIORITY||Mean Difference (Final Values)|-1.38|||<|0.0001|TWO_SIDED|95.0|-1.88|-0.87|||ANCOVA|||||-0.87|-1.88|<0.0001
71026977|NCT02974153|141561100|SUPERIORITY||Mean Difference (Final Values)|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.66|-0.65|||ANCOVA|||||-0.65|-1.66|<0.0001
71026978|NCT02974153|141561101|SUPERIORITY||Mean Difference (Final Values)|-2.88|||<|0.0001|TWO_SIDED|95.0|-3.91|-1.84|||ANCOVA|||||-1.84|-3.91|<0.0001
71026979|NCT02974153|141561101|SUPERIORITY||Mean Difference (Final Values)|-1.73||||0.001|TWO_SIDED|95.0|-2.76|-0.7|||ANCOVA|||||-0.70|-2.76|0.0010
71026980|NCT02974153|141561102|SUPERIORITY||Mean Difference (Final Values)|-11.0|||<|0.0001|TWO_SIDED|95.0|-14.22|-7.77|||Repeated Measures Model|||||-7.77|-14.22|<0.0001
70852239|NCT04145219|141192905|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.0259|TWO_SIDED|95.0|0.0|0.2|||Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average asthma DSS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.2|0.0|0.0259
70935808|NCT00824408|141372684|SUPERIORITY_OR_OTHER|||||||0.2596|||||||Fisher Exact|||||||0.2596
71026981|NCT02974153|141561102|SUPERIORITY||Mean Difference (Final Values)|-8.26|||<|0.0001|TWO_SIDED|95.0|-11.48|-5.05|||Repeated Measures Model|||||-5.05|-11.48|<0.0001
71026982|NCT02277769|141561122|SUPERIORITY||difference in percentages|27.6|||<|0.0001|TWO_SIDED|95.0|20.46|34.69||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||34.69|20.46|< 0.0001
71026983|NCT02277769|141561122|SUPERIORITY||difference in percentages|27.9|||<|0.0001|TWO_SIDED|95.0|20.87|34.99||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||34.99|20.87|< 0.0001
71026984|NCT02277769|141561123|SUPERIORITY||difference in percentages|32.3|||<|0.0001|TWO_SIDED|95.0|24.75|39.94||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||39.94|24.75|< 0.0001
71026985|NCT02277769|141561123|SUPERIORITY||difference in percentages|36.3|||<|0.0001|TWO_SIDED|95.0|28.69|43.81||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||43.81|28.69|< 0.0001
71026986|NCT02277769|141561124|SUPERIORITY||difference in percentages|26.5|||<|0.0001|TWO_SIDED|95.0|19.13|33.87||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||33.87|19.13|< 0.0001
71026987|NCT02277769|141561124|SUPERIORITY||difference in percentages|29.5|||<|0.0001|TWO_SIDED|95.0|22.11|36.95||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||36.95|22.11|< 0.0001
71026988|NCT02277769|141561125|SUPERIORITY||difference in percentages|37.8|||<|0.0001|TWO_SIDED|95.0|30.03|45.6||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||45.60|30.03|< 0.0001
71026989|NCT02277769|141561125|SUPERIORITY||difference in percentages|36.3|||<|0.0001|TWO_SIDED|95.0|28.56|44.06||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||44.06|28.56|< 0.0001
71026990|NCT02277769|141561126|SUPERIORITY||LS mean difference|-28.9|||<|0.0001|TWO_SIDED|95.0|-36.04|-21.83||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-21.83|-36.04|< 0.0001
71026991|NCT02277769|141561126|SUPERIORITY||Least square (LS) mean difference|-32.8|||<|0.0001|TWO_SIDED|95.0|-40.2|-25.49||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-25.49|-40.20|< 0.0001
71059629|NCT03718832|141626342|SUPERIORITY||Mean Difference (Net)|0.2794625|STANDARD_ERROR_OF_MEAN|0.2717457||0.3044732|TWO_SIDED|95.0|-0.2549974|0.8139224||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.8139224|-0.2549974|0.3044732
71026992|NCT02277769|141561127|SUPERIORITY||difference in percentages|16.3|||<|0.0001|TWO_SIDED|95.0|9.99|22.68||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||22.68|9.99|< 0.0001
71026993|NCT02277769|141561127|SUPERIORITY||difference in percentages|21.3|||<|0.0001|TWO_SIDED|95.0|14.66|27.93||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||27.93|14.66|< 0.0001
71026994|NCT02277769|141561128|SUPERIORITY||difference in percentages|9.8|||<|0.0001|TWO_SIDED|95.0|5.54|13.98||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||13.98|5.54|< 0.0001
71059630|NCT03718832|141626343|SUPERIORITY||Mean Difference (Net)|9.768353|STANDARD_ERROR_OF_MEAN|5.933945||0.1007463|TWO_SIDED|95.0|-1.907847|21.44455||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||21.44455|-1.907847|0.1007463
71059631|NCT03718832|141626343|SUPERIORITY||Mean Difference (Net)|4.472004|STANDARD_ERROR_OF_MEAN|5.150772||0.3859868|TWO_SIDED|95.0|-5.66534|14.60935||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||14.60935|-5.66534|0.3859868
70852240|NCT04145219|141192906|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0527|TWO_SIDED|95.0|1.0|3.3|||Generalised linear mixed model (GLMM)||Odds ratio is (odds 12 SQ-HDM / odds Placebo)|The odds of having a SABA free day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model included SABA free day (yes/no) as response variable, treatment and cohort as fixed effects, the baseline average asthma DSS as a covariate, the combined (country/region) variable within cohort and subject as random effects. Proportion is the estimated probability of having a day where a subject with asthma did not use SABA, odds ratio is (odds active/odds Placebo).||3.3|1.0|0.0527
70852241|NCT04145219|141192907|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.1256|TWO_SIDED|95.0|-0.1|1.0|||Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The endpoint was analysed using a linear mixed effect (LME) model. The model includes the endpoint as response variable, treatment and cohort as fixed factors, the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||1.0|-0.1|0.1256
70852242|NCT04145219|141192908|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0008|TWO_SIDED|95.0|1.3|2.5|||Generalised linear mixed model (GLMM)||Odds ratio is (odds 12 SQ-HDM / odds Placebo)|The odds of having a rhinitis mild day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model included the endpoint (yes/no) as response variable, treatment and cohort as fixed effects, the baseline average rhinitis TCRS as a covariate, the combined (country/region) variable within cohort and subject as random effects. Proportion is the estimated probability of having a day with no or mild rhinitis symptoms, odds ratio is (odds 12 SQ-HDM / odds Placebo).||2.5|1.3|0.0008
70852243|NCT04145219|141192909|SUPERIORITY||Odds Ratio (OR)|0.6|||<|0.0001|TWO_SIDED|95.0|0.4|0.7|||Generalised linear mixed model (GLMM)||Odds ratio is (odds 12 SQ-HDM / odds Placebo)|The odds of having a rhinitis exacerbation day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model included the endpoint (yes/no) as response variable, treatment and cohort as fixed effects, the baseline average rhinitis DSS as a covariate, the combined (country/region) variable within cohort and subject as random effects. Proportion is the estimated probability of having a rhinitis exacerbation day, odds ratio is (odds 12 SQ-HDM / odds Placebo).||0.7|0.4|<0.0001
70852244|NCT04145219|141192910|SUPERIORITY||Mean Difference (Final Values)|0.2|||<|0.0001|TWO_SIDED|95.0|0.1|0.3|||Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average rhinitis CSMS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.3|0.1|<0.0001
71026995|NCT02277769|141561128|SUPERIORITY||difference in percentages|11.8|||<|0.0001|TWO_SIDED|95.0|7.31|16.32||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||16.32|7.31|< 0.0001
71026996|NCT02277769|141561129|SUPERIORITY||LS mean difference|-2.1|||<|0.0001|TWO_SIDED|95.0|-2.605|-1.587||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-1.587|-2.605|< 0.0001
71026997|NCT02277769|141561129|SUPERIORITY||LS mean difference|-2.47|||<|0.0001|TWO_SIDED|95.0|-2.982|-1.957||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-1.957|-2.982|< 0.0001
71026998|NCT02277769|141561130|SUPERIORITY||LS mean difference|-36.2|||<|0.0001|TWO_SIDED|95.0|-43.46|-28.86|||ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-28.86|-43.46|< 0.0001
71026999|NCT02277769|141561130|SUPERIORITY||LS mean difference|-38.2|||<|0.0001|TWO_SIDED|95.0|-45.55|-30.88||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-30.88|-45.55|< 0.0001
71027000|NCT02277769|141561131|SUPERIORITY||difference in percentages|43.2|||<|0.0001|TWO_SIDED|95.0|35.12|51.29||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||51.29|35.12|< 0.0001
71027001|NCT02277769|141561131|SUPERIORITY||difference in percentages|39.1|||<|0.0001|TWO_SIDED|95.0|30.92|47.19||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||47.19|30.92|< 0.0001
71027002|NCT02277769|141561132|SUPERIORITY||difference in percentages|22.8|||<|0.0001|TWO_SIDED|95.0|16.09|29.59||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||29.59|16.09|< 0.0001
71027003|NCT02277769|141561132|SUPERIORITY||difference in percentages|23.3|||<|0.0001|TWO_SIDED|95.0|16.63|30.05||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||30.05|16.63|< 0.0001
71109434|NCT04046939|141724284|SUPERIORITY||Mean Difference (Final Values)|-0.00215||||0.814|TWO_SIDED|95.0|-0.0203|0.016||No adjustment for multiple testing of exploratory endpoints was used.|Mixed Models Analysis||Estimate is the difference of the 37.5 mg BID group from the placebo group in the change absolute basophil count (automated differential) from Baseline to Week 12 (end of primary treatment period). A negative value represents fewer basophils.|The 37.5 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM) with terms for baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the post-baseline value minus the baseline value.||0.0160|-0.0203|0.8140
71109435|NCT04046939|141724285|SUPERIORITY||Mean Difference (Final Values)|-8.24||||0.1886|TWO_SIDED|95.0|-20.6|4.13||No adjustment for multiple testing of exploratory endpoints was used.|Mixed Models Analysis||Estimate is the difference of the 150 mg BID group from the placebo group in the change in FeNO from Baseline to Week 12 in liters. In eosinophilic asthma, a lower FeNO indicates less eosinophilic inflammation of the airway than a higher value.|The 150 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM) with terms for baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the post-baseline value minus the baseline value.||4.13|-20.6|0.1886
71109436|NCT04046939|141724285|SUPERIORITY||Mean Difference (Final Values)|-6.53||||0.3061|TWO_SIDED|95.0|-19.1|6.08||No adjustment for multiple testing of exploratory endpoints was used.|Mixed Models Analysis||Estimate is the difference of the 75 mg BID group from the placebo group in the change in FeNO from Baseline to Week 12 in liters. In eosinophilic asthma, a lower FeNO indicates less eosinophilic inflammation of the airway than a higher value.|The 75mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM) with terms for baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the post-baseline value minus the baseline value.||6.08|-19.1|0.3061
71109437|NCT04046939|141724285|SUPERIORITY||Mean Difference (Final Values)|-10.2||||0.1294|TWO_SIDED|95.0|-23.4|3.04||No adjustment for multiple testing of exploratory endpoints was used.|Mixed Models Analysis||Estimate is the difference of the 37.5 mg BID group from the placebo group in the change in FeNO from Baseline to Week 12 in liters. In eosinophilic asthma, a lower FeNO indicates less eosinophilic inflammation of the airway than a higher value.|The 37.5 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM) with terms for baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the post-baseline value minus the baseline value.||3.04|-23.4|0.1294
71109438|NCT00806260|141724290|NON_INFERIORITY_OR_EQUIVALENCE|step down test|Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.07|||ONE_SIDED|90.0|0.21||||ANCOVA|||at alcohol level 0.10%|||0.21|
71109439|NCT00806260|141724290|NON_INFERIORITY_OR_EQUIVALENCE|step down test|Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.05|||ONE_SIDED|90.0|0.12||||ANCOVA|||at alcohol level 0.07%|||0.12|
71109440|NCT00806260|141724290|NON_INFERIORITY_OR_EQUIVALENCE|step-down test|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.06|||ONE_SIDED|90.0|-0.03||||ANCOVA|||at alcohol level 0.04%|||-0.03|
71109441|NCT00806260|141724291|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|95.0|-0.17|0.07|||ANCOVA|||at 2 hr timepoint||0.07|-0.17|
71109442|NCT00806260|141724291|NON_INFERIORITY_OR_EQUIVALENCE|non inferiority test|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.18|0.04|||ANCOVA|||at 6 hr timepoint||0.04|-0.18|
71109443|NCT00806260|141724291|NON_INFERIORITY_OR_EQUIVALENCE|non inferiority|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.08|0.06|||ANCOVA|||at 2 hr timepoint||0.06|-0.08|
70935809|NCT00824408|141372685|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.073||||0.8406|TWO_SIDED|95.0|0.538|2.14|||Log Rank|||||2.140|0.538|0.8406
70935810|NCT00824408|141372685|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.081||||0.396|TWO_SIDED|95.0|0.599|1.949|||Log Rank|||||1.949|0.599|0.3960
71027004|NCT02277769|141561133|SUPERIORITY||LS mean difference|-17.99|||<|0.0001|TWO_SIDED|95.0|-22.062|-13.927||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-13.927|-22.062|< 0.0001
71027005|NCT02277769|141561133|SUPERIORITY||LS mean difference|-19.51|||<|0.0001|TWO_SIDED|95.0|-23.491|-15.529||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-15.529|-23.491|< 0.0001
71027006|NCT02277769|141561134|SUPERIORITY||LS mean difference|-31.4|||<|0.0001|TWO_SIDED|95.0|-37.36|-25.4||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-25.40|-37.36|< 0.0001
71027007|NCT02277769|141561134|SUPERIORITY||LS mean difference|-33.8|||<|0.0001|TWO_SIDED|95.0|-39.75|-27.8||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-27.80|-39.75|< 0.0001
71027008|NCT02277769|141561135|SUPERIORITY||LS mean difference|-5.7|||<|0.0001|TWO_SIDED|95.0|-6.86|-4.47||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-4.47|-6.86|< 0.0001
71027009|NCT02277769|141561135|SUPERIORITY||LS mean difference|-5.9|||<|0.0001|TWO_SIDED|95.0|-7.1|-4.72||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-4.72|-7.10|< 0.0001
71027010|NCT02277769|141561136|SUPERIORITY||LS mean difference|-7.0|||<|0.0001|TWO_SIDED|95.0|-8.36|-5.57||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-5.57|-8.36|< 0.0001
71027011|NCT02277769|141561136|SUPERIORITY||LS mean difference|-8.0|||<|0.0001|TWO_SIDED|95.0|-9.36|-6.64||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-6.64|-9.36|< 0.0001
71027012|NCT02277769|141561137|SUPERIORITY||LS mean difference|-4.2|||<|0.0001|TWO_SIDED|95.0|-5.34|-3.09||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-3.09|-5.34|< 0.0001
71027013|NCT02277769|141561137|SUPERIORITY||LS mean difference|-4.9|||<|0.0001|TWO_SIDED|95.0|-6.04|-3.81||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-3.81|-6.04|< 0.0001
71027014|NCT02277769|141561138|SUPERIORITY||LS mean difference|-27.7|||<|0.0001|TWO_SIDED|95.0|-33.73|-21.7||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-21.70|-33.73|< 0.0001
71027015|NCT02277769|141561138|SUPERIORITY||LS mean difference|-28.9|||<|0.0001|TWO_SIDED|95.0|-35.03|-22.74||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-22.74|-35.03|< 0.0001
71027016|NCT02277769|141561139|SUPERIORITY||LS mean difference|-17.7|||<|0.0001|TWO_SIDED|95.0|-21.96|-13.53||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-13.53|-21.96|< 0.0001
71027017|NCT02277769|141561139|SUPERIORITY||LS mean difference|-15.0|||<|0.0001|TWO_SIDED|95.0|-19.16|-10.78||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-10.78|-19.16|< 0.0001
71027018|NCT03504852|141561143|SUPERIORITY||Risk Difference (RD)|17.72||||0.0003|TWO_SIDED|95.0|7.45|27.98||One-sided p-value|Regression, Logistic|||||27.98|7.45|0.0003
71027019|NCT03504852|141561143|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0003|TWO_SIDED|95.0|1.44|3.78||One-sided p-value|Regression, Logistic|||||3.78|1.44|0.0003
71027020|NCT03504852|141561144|SUPERIORITY||Risk Difference (RD)|8.28||||0.0498|TWO_SIDED|95.0|-1.65|18.2||One-sided p-value|Regression, Logistic|||||18.20|-1.65|0.0498
71027021|NCT03504852|141561144|SUPERIORITY||Odds Ratio (OR)|1.51||||0.0498|TWO_SIDED|95.0|0.92|2.47||One-sided p-value|Regression, Logistic|||||2.47|0.92|0.0498
71027022|NCT02928848|141561146|OTHER|||||||0.14||||||The a priori threshold for statistical significance was p \< .05.|ANOVA|||Repeated-measures analysis of variance (RM-ANOVA) with Condition (active, sham) and time point (baseline, 0-week) as within-subject factors. Analysis tests whether active vs. sham stimulation confers a greater improvement in overall language ability, as measured by the Western Aphasia Battery Aphasia Quotient (WAB-AQ), that endures over time.||||0.14
71027023|NCT02928848|141561147|OTHER|||||||0.02||||||The a priori threshold for statistical significance was p \< .05.|ANOVA|||Repeated-measures analysis of variance (RM-ANOVA) with Condition (active, sham) and time point (baseline, 0-weeks) as within-subject factors. Analysis tests whether active vs. sham stimulation confers a greater improvement in naming ability, as measured by the naming subtest of the WAB, that endures over time.||||.02
71029294|NCT01046253|141566124|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.0|||||TWO_SIDED|90.0|97.4|114.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||114|97.4|
71059632|NCT03718832|141626343|SUPERIORITY||Mean Difference (Net)|-0.5461143|STANDARD_ERROR_OF_MEAN|6.440905||0.9324908|TWO_SIDED|95.0|-13.22545|12.13323||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Unadjusted mean difference, 12 months after trial enrollment||12.13323|-13.22545|0.9324908
71109444|NCT00806260|141724291|NON_INFERIORITY_OR_EQUIVALENCE|non inferiority|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-0.13|0.05|||ANCOVA|||at 6 hr timepoint||0.05|-0.13|
70852245|NCT04145219|141192911|SUPERIORITY||Mean Difference (Final Values)|0.2|||<|0.0001|TWO_SIDED|95.0|0.1|0.3|||Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average rhinoconjunctivitis CSMS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.3|0.1|<0.0001
71027024|NCT00582309|141561167|NON_INFERIORITY_OR_EQUIVALENCE|Original Power Analysis: The expected differences in mean blood glucose concentration between groups are \> 30 mg/dL. Assuming two-tailed alpha of .05, a standard deviation of approximately 40, and a one-to-one allocation and no subject attrition, fifty patients per treatment group (150 total) will be sufficient to achieve 90% power for group mean comparisons allowing for multiple comparisons.|||||<|0.05|TWO_SIDED|95.0||||All results obtained by ANOVA are verified by the nonparametric Kruskal-Wallis test. Statistical significance will be judged by P-values \< 0.05.|ANOVA|||Demographic and baseline measurements are reported as either means and standard deviations or as frequency and percentages. These and the outcome measures are compared among the three groups by 1-way analysis of variance (ANOVA) for means or by Fisher's Exact test for frequencies as appropriate. If there is an overall significant difference, the post hoc multiple comparisons will be done by Fisher's least significant difference method.||||<0.05
71027025|NCT00455533|141561189|SUPERIORITY_OR_OTHER|||||||0.8921||95.0|||||Fisher Exact|||||||0.8921
71027026|NCT00455533|141561189|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8966|TWO_SIDED|90.0|0.6|1.55|||Cochran-Mantel-Haenszel|||||1.55|0.60|0.8966
71027027|NCT00455533|141561189|SUPERIORITY_OR_OTHER||difference in pCR|-0.6|||||TWO_SIDED|95.0|-7.9|6.7|||||The difference in pCR rates and the confidence interval computed using the method of DerSimonian and Laird stratified by tumor size at baseline, estrogen receptor status, and clinical response to AC.|||6.7|-7.9|
71027028|NCT00455533|141561192|SUPERIORITY_OR_OTHER|||||||0.6186||95.0|||||Fisher Exact|||||||0.6186
71027029|NCT00455533|141561192|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.5806|TWO_SIDED|90.0|0.56|1.34|||Cochran-Mantel-Haenszel|||||1.34|0.56|0.5806
71027030|NCT00455533|141561192|SUPERIORITY_OR_OTHER||difference|-2.5|||||TWO_SIDED|90.0|-11.0|6.0|||||The difference in pCR/RCB-I rates and the confidence interval computed using the method of DerSimonian and Laird stratified by tumor size at baseline, estrogen receptor status, and clinical response to AC.|||6.0|-11|
71027031|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.4115||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 (209993\_at)||||0.4115
71027032|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.1629||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 209993\_at||||0.1629
71027033|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.5074||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 209993\_at||||0.5074
71027034|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.553||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994\_s\_at||||0.5530
71027035|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.1845||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994\_s\_at||||0.1845
71027036|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.3538||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994\_s\_at||||0.3538
71027037|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.9751||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851\_x\_at||||0.9751
71027038|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.8874||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851\_x\_at||||0.8874
71027039|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.6907||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851\_x\_at||||0.6907
71027040|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.8052||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531\_s\_at||||0.8052
71027041|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.5031||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531\_s\_at||||0.5031
71027042|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.7588||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531\_s\_at||||0.7588
71027043|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.1542||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719\_at||||0.1542
71027044|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.0235||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719\_at||||0.0235
71027045|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.3612||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719\_at||||0.3612
71027046|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.184||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720\_s\_at||||0.1840
71027047|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.0942||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720\_s\_at||||0.0942
71027048|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.5327||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720\_s\_at||||0.5327
71027049|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.8847||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315\_s\_at||||0.8847
71027050|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.8947||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315\_s\_at||||0.8947
71027051|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.4085||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315\_s\_at||||0.4085
71027052|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.1119||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317\_at||||0.1119
71027053|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317\_at||||0.0250
71027054|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.3569||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317\_at||||0.3569
71027055|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.4103||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942\_s\_at||||0.4103
70935811|NCT00046475|141372705|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 1 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||||||<0.001
71027056|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.149||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942\_s\_at||||0.1490
71027057|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.559||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942\_s\_at||||0.5590
71027058|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.4796||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318\_s\_at||||0.4796
71059633|NCT03718832|141626343|SUPERIORITY||Mean Difference (Net)|-2.752831|STANDARD_ERROR_OF_MEAN|5.754947||0.6328075|TWO_SIDED|95.0|-14.08487|8.579205||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||8.579205|-14.08487|0.6328075
71059634|NCT03718832|141626344|SUPERIORITY||Mean Difference (Net)|8.352141|STANDARD_ERROR_OF_MEAN|4.663846||0.0743062|TWO_SIDED|95.0|-0.8250086|17.52929||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment.||17.52929|-0.8250086|0.0743062
71027059|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.2794||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318\_s\_at||||0.2794
70935812|NCT00046475|141372706|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||||||0.011
71027060|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.1646||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318\_s\_at||||0.1646
71027061|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.0782||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040\_x\_at||||0.0782
71027062|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.1407||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040\_x\_at||||0.1407
71027063|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.2369||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040\_x\_at||||0.2369
71027064|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.7756||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792\_s\_at||||0.7756
71027065|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.2623||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792\_s\_at||||0.2623
71027066|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.3147||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792\_s\_at||||0.3147
71027067|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.2885||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808\_at||||0.2885
71027068|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.7187||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808\_at||||0.7187
71027069|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.6017||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808\_at||||0.6017
71027070|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242\_s\_at||||0.4500
71027071|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.0952||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242\_s\_at||||0.0952
71027072|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.7069||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242\_s\_at||||0.7069
71027073|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.4767||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733\_at||||0.4767
71027074|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.6191||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733\_at||||0.6191
70935813|NCT00046475|141372707|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 2 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 2||||<0.001
71027075|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.5276||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733\_at||||0.5276
71027076|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.3323||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476\_s\_at||||0.3323
71027077|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.1025||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476\_s\_at||||0.1025
71027078|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.1715||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476\_s\_at||||0.1715
71027079|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477\_s\_at||||0.1070
71027080|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.2751||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477\_s\_at||||0.2751
71027081|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.0276||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477\_s\_at||||0.0276
71027082|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.1689||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714\_x\_at||||0.1689
71027083|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.0769||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714\_x\_at||||0.0769
71027084|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.1058||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714\_x\_at||||0.1058
71027085|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.6406||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320\_at||||0.6406
71027086|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.1733||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320\_at||||0.1733
71027087|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.2631||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320\_at||||0.2631
71027088|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.217||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026\_x\_at||||0.2170
71027089|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.0868||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026\_x\_at||||0.0868
71027090|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.1117||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026\_x\_at||||0.1117
71027091|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.4943||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 (208601\_s\_at)||||0.4943
71027092|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.519||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 208601\_s\_at||||0.5190
71027093|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.735||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 208601\_s\_at||||0.7350
71027094|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141\_at||||0.3820
71059635|NCT03718832|141626344|SUPERIORITY||Mean Difference (Net)|5.971188|STANDARD_ERROR_OF_MEAN|3.902349||0.1270654|TWO_SIDED|95.0|-1.709219|13.65159||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||13.65159|-1.709219|0.1270654
71027095|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.929||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141\_at||||0.9290
71059636|NCT03718832|141626344|SUPERIORITY||Mean Difference (Net)|2.637485|STANDARD_ERROR_OF_MEAN|4.443227||0.553277|TWO_SIDED|95.0|-6.110146|11.38512||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||11.38512|-6.110146|0.553277
71059637|NCT03718832|141626344|SUPERIORITY||Mean Difference (Net)|2.53149|STANDARD_ERROR_OF_MEAN|3.925307||0.519562|TWO_SIDED|95.0|-5.198658|10.26164||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||10.26164|-5.198658|0.519562
71059638|NCT03718832|141626345|SUPERIORITY||Mean Difference (Net)|-0.555117|STANDARD_ERROR_OF_MEAN|1.427417||0.6976216|TWO_SIDED|95.0|-3.363839|2.253605||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||2.253605|-3.363839|0.6976216
71027096|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.0699||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141\_at||||0.0699
71027097|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.3515||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372\_x\_at||||0.3515
71027098|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.2128||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372\_x\_at||||0.2128
71027099|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.1275||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372\_x\_at||||0.1275
71059639|NCT03718832|141626345|SUPERIORITY||Mean Difference (Net)|-0.4977997|STANDARD_ERROR_OF_MEAN|1.041102||0.6329035|TWO_SIDED|95.0|-2.546815|1.551216||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||1.551216|-2.546815|0.6329035
71027100|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.2158||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023\_x\_at||||0.2158
71027101|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.0266||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023\_x\_at||||0.0266
71027102|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.3636||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023\_x\_at||||0.3636
71027103|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.9479||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977\_x\_at||||0.9479
71027104|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.3753||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977\_x\_at||||0.3753
71027105|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.5477||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977\_x\_at||||0.5477
71027106|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.476||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726\_x\_at||||0.4760
71027107|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.3314||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726\_x\_at||||0.3314
71027108|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.1005||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726\_x\_at||||0.1005
71027109|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.118||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664\_at||||0.1180
71027110|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.158||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664\_at||||0.1580
71027111|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.4385||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664\_at||||0.4385
71027112|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.7324||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191\_at||||0.7324
71109445|NCT00896012|141724297|OTHER|||||||0.222||||||Significance was considered to be P \< .05|t-test, 2 sided|||Statistical analysis was performed by analysis of variance and Student t test for estimated glomerular filtration rate (eGFR) at 12 months. Chi-square analysis was used for demographics data.||||0.222
71109446|NCT02735421|141724299|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71109447|NCT00939107|141724311|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5|||>|0.05||95.0|0.2|2.8|||t-test, 2 sided|||||2.8|0.2|>0.05
71109448|NCT01861665|141724328|SUPERIORITY|||||||0.8379||||||Pre Incision vs. Post Incision on Post op day 0.|t-test, 2 sided|||||||0.8379
71027113|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.2657||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191\_at||||0.2657
71027114|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.5637||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191\_at||||0.5637
71027115|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.4473||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589\_at||||0.4473
71027116|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.3292||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589\_at||||0.3292
71109449|NCT01861665|141724328|SUPERIORITY|||||||0.7263||||||Pre incision vs. Post incision post op day 1.|t-test, 2 sided|||||||0.7263
71109450|NCT01861665|141724328|SUPERIORITY|||||||0.5||||||Pre incision vs. Post incision day 2.|t-test, 2 sided|||||||0.5
71109451|NCT03247829|141724329|OTHER|||||||0.001|||||||t-test, 2 sided|Comparative p-values were calculated by two-sided t-tests (paired analysis).||||||0.001
71109452|NCT03247829|141724330|OTHER|||||||0.0931|||||||t-test, 2 sided|||||||0.0931
71109453|NCT01783444|141724338|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|0.74|||||TWO_SIDED|90.0|0.57|0.97||||||||0.97|0.57|
71109454|NCT01783444|141724339|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|1.26|||||TWO_SIDED|90.0|0.96|1.66||||||||1.66|0.96|
70935814|NCT00046475|141372707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 3 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 3||||0.002
71027117|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.2054||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589\_at||||0.2054
71027118|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.5226||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684\_at||||0.5226
71027119|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.172||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684\_at||||0.1720
71027120|NCT00455533|141561193|SUPERIORITY_OR_OTHER|||||||0.3346||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684\_at||||0.3346
71027121|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.5604||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 209993\_at||||0.5604
71027122|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.2715||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 209993\_at||||0.2715
71027123|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.5268||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 209993\_at||||0.5268
71027124|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.6058||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994\_s\_at||||0.6058
70935815|NCT00046475|141372707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 4 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 4||||0.004
70935816|NCT00046475|141372707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 5 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 5||||0.026
70935817|NCT00046475|141372707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.226|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 6 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 6||||0.226
71027125|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.1918||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994\_s\_at||||0.1918
71027126|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.6712||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994\_s\_at||||0.6712
71027127|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.9195||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851\_x\_at||||0.9195
71027128|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.7021||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851\_x\_at||||0.7021
71027129|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.391||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851\_x\_at||||0.3910
71027130|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.2909||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531\_s\_at||||0.2909
71027131|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.3336||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531\_s\_at||||0.3336
70935818|NCT00046475|141372708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment composite symptom score as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||||||0.002
70935819|NCT00046475|141372709|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHDAS Item 1 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 1||||<0.001
71027132|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.236||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531\_s\_at||||0.2360
71027133|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.0281||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719\_at||||0.0281
71027134|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.0434||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719\_at||||0.0434
71027135|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.0283||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719\_at||||0.0283
71027136|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.0151||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720\_s\_at||||0.0151
71027137|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.1999||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720\_s\_at||||0.1999
70935820|NCT00046475|141372709|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHDAS Item 2 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 2||||<0.001
71027138|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.0146||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720\_s\_at||||0.0146
71027139|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.1185||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315\_s\_at||||0.1185
71027140|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.8705||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315\_s\_at||||0.8705
71027141|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.0284||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315\_s\_at||||0.0284
71027142|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.0399||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317\_at||||0.0399
71027143|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.0136||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317\_at||||0.0136
71027144|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.0576||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317\_at||||0.0576
71027145|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.2245||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942\_s\_at||||0.2245
71059640|NCT03718832|141626345|SUPERIORITY||Mean Difference (Net)|-1.386111|STANDARD_ERROR_OF_MEAN|1.812939||0.445181|TWO_SIDED|95.0|-4.954999|2.182777||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||2.182777|-4.954999|0.445181
71027146|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.1388||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942\_s\_at||||0.1388
71027147|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.0692||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942\_s\_at||||0.0692
71027148|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.1058||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318\_s\_at||||0.1058
71027149|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.2688||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318\_s\_at||||0.2688
71059641|NCT03718832|141626345|SUPERIORITY||Mean Difference (Net)|-1.101914|STANDARD_ERROR_OF_MEAN|1.860687||0.5542241|TWO_SIDED|95.0|-4.765783|2.561956||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||2.561956|-4.765783|0.5542241
71027150|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.0192||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318\_s\_at||||0.0192
71059642|NCT03718832|141626346|SUPERIORITY||Mean Difference (Net)|22.55812|STANDARD_ERROR_OF_MEAN|17.74244||0.2045348|TWO_SIDED|95.0|-12.35316|57.4694||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||57.4694|-12.35316|0.2045348
70852246|NCT01099449|141192991|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in\>\> primary analysis.||||||0.73|||||||Wilcoxon (Mann-Whitney)|||Two-sample t-tests or Wilcoxon rank-sum tests will be used\>\> to compare the AUC of CIPN sensory subscale between each of the two schedules of\>\> Ca/Mg infusions vs placebo arms at the 2.5% significance level. If the CIPN sensory\>\> subscales are observed to be unbalanced, we will adjust for the baseline CIPN sensory\>\> subscale scores from the AUC or incorporate them as a covariate in generalized linear\>\> regression model.||||.73
70852247|NCT01099449|141192991|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in\>\> primary analysis.||||||0.29|||||||Wilcoxon (Mann-Whitney)|||Two-sample t-tests or Wilcoxon rank-sum tests will be used\>\> to compare the AUC of CIPN sensory subscale between each of the two schedules of\>\> Ca/Mg infusions vs placebo arms at the 2.5% significance level. If the CIPN sensory\>\> subscales are observed to be unbalanced, we will adjust for the baseline CIPN sensory\>\> subscale scores from the AUC or incorporate them as a covariate in generalized linear\>\> regression model.||||.29
70935821|NCT00046475|141372709|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is based on an ANOVA model with post-treatment responses for OHDAS Item 3 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 3||||<0.001
71027151|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.0033||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040\_x\_at||||0.0033
71027152|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.2053||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040\_x\_at||||0.2053
71027153|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.0032||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040\_x\_at||||0.0032
71027154|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.6783||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792\_s\_at||||0.6783
71027155|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.163||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792\_s\_at||||0.1630
71027156|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.2944||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792\_s\_at||||0.2944
71027157|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.3727||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808\_at||||0.3727
71027158|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.8796||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808\_at||||0.8796
71027159|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.8344||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808\_at||||0.8344
71027160|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.27||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242\_s\_at||||0.2700
71027161|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.2624||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242\_s\_at||||0.2624
71027162|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242\_s\_at||||0.0830
71027163|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.0849||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733\_at||||0.0849
71027164|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.6578||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733\_at||||0.6578
71027165|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.0396||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733\_at||||0.0396
71027166|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.1657||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476\_s\_at||||0.1657
71027167|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.0675||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476\_s\_at||||0.0675
70852248|NCT01099449|141192992|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in\>\> primary analysis.||||||0.054|||||||Wilcoxon (Mann-Whitney)|||We will not adjust p-values (or significance level) for multiple\>\> comparisons among the numerous hypothesis testings of secondary endpoints due to the\>\> exploratory nature of these secondary analyses. The significance results from secondary\>\> analyses will be interpreted cautiously in a hypothesis-generating fashion.||||.054
70852249|NCT01099449|141192992|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in\>\> primary analysis.||||||0.27|||||||Wilcoxon (Mann-Whitney)|||We will not adjust p-values (or significance level) for multiple\>\> comparisons among the numerous hypothesis testings of secondary endpoints due to the\>\> exploratory nature of these secondary analyses. The significance results from secondary\>\> analyses will be interpreted cautiously in a hypothesis-generating fashion.||||.27
70852250|NCT01099449|141192993|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in\>\> primary analysis.||||||0.29|||||||Wilcoxon (Mann-Whitney)|||We will not adjust p-values (or significance level) for multiple\>\> comparisons among the numerous hypothesis testings of secondary endpoints due to the\>\> exploratory nature of these secondary analyses. The significance results from secondary\>\> analyses will be interpreted cautiously in a hypothesis-generating fashion.||||.29
70852251|NCT01099449|141192993|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in\>\> primary analysis.||||||0.25|||||||Wilcoxon (Mann-Whitney)|||We will not adjust p-values (or significance level) for multiple\>\> comparisons among the numerous hypothesis testings of secondary endpoints due to the\>\> exploratory nature of these secondary analyses. The significance results from secondary\>\> analyses will be interpreted cautiously in a hypothesis-generating fashion.||||.25
70852252|NCT01099449|141192996|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Kruskal Wallis Analysis||||||0.89|||||||Kruskal-Wallis|||||||.89
71027168|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.1071||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476\_s\_at||||0.1071
71027169|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.0142||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477\_s\_at||||0.0142
71027170|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.2465||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477\_s\_at||||0.2465
70852253|NCT01099449|141192996|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Kruskal Wallis Analysis||||||0.496|||||||Kruskal-Wallis|||||||.496
70852254|NCT01099449|141192997|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Chi-Squared Analysis||||||0.52|||||||Chi-squared|||||||.52
71027171|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.0031||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477\_s\_at||||0.0031
71027172|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.1231||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714\_x\_at||||0.1231
71027173|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.0849||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714\_x\_at||||0.0849
71027174|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.274||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714\_x\_at||||0.2740
71027175|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.2383||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320\_at||||0.2383
71059643|NCT03718832|141626346|SUPERIORITY||Mean Difference (Net)|13.49781|STANDARD_ERROR_OF_MEAN|14.95579||0.3675252|TWO_SIDED|95.0|-15.93658|42.9322||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||42.9322|-15.93658|0.3675252
71027176|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.0644||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320\_at||||0.0644
71027177|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.2866||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320\_at||||0.2866
71109455|NCT01783444|141724340|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|1.27|||||TWO_SIDED|90.0|0.95|1.7||||||||1.70|0.95|
70852255|NCT01099449|141192997|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Chi-Squared Analysis||||||0.66|||||||Chi-squared|||||||.66
70852256|NCT00612105|141193001|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.43||||0.2537|TWO_SIDED|95.0|-1.171|0.312|||ANCOVA|||||0.312|-1.171|0.2537
71027178|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.1259||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026\_x\_at||||0.1259
71027179|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.0718||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026\_x\_at||||0.0718
71027180|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.317||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026\_x\_at||||0.3170
71059644|NCT03718832|141626346|SUPERIORITY||Mean Difference (Net)|-11.35256|STANDARD_ERROR_OF_MEAN|26.69115||0.6709307|TWO_SIDED|95.0|-63.8992|41.19407||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||41.19407|-63.8992|0.6709307
71059645|NCT03718832|141626346|SUPERIORITY||Mean Difference (Net)|-8.912496|STANDARD_ERROR_OF_MEAN|21.34891||0.6766844|TWO_SIDED|95.0|-50.95358|33.12859||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||33.12859|-50.95358|0.6766844
71059646|NCT03718832|141626347|SUPERIORITY||Mean Difference (Net)|-1.870464|STANDARD_ERROR_OF_MEAN|2.024497||0.356123|TWO_SIDED|95.0|-5.851219|2.110291||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||2.110291|-5.851219|0.356123
71059647|NCT03718832|141626347|SUPERIORITY||Mean Difference (Net)|-0.8636408|STANDARD_ERROR_OF_MEAN|1.941141||0.6566494|TWO_SIDED|95.0|-4.681041|2.95376||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||2.95376|-4.681041|0.6566494
71059648|NCT03718832|141626347|SUPERIORITY||Mean Difference (Net)|-3.772051|STANDARD_ERROR_OF_MEAN|1.905125||0.0484944|TWO_SIDED|95.0|-7.519021|-0.0250809||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||-0.0250809|-7.519021|0.0484944
71109456|NCT01783444|141724340|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|1.33|||||TWO_SIDED|90.0|0.99|1.79||||||||1.79|0.99|
71109457|NCT01783444|141724343|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|1.09|||||TWO_SIDED|90.0|0.72|1.66||||||||1.66|0.72|
71109458|NCT01783444|141724343|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|1.18|||||TWO_SIDED|90.0|0.78|1.77||||||||1.77|0.78|
70935822|NCT00046475|141372709|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHDAS Item 4 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 4||||0.001
71027181|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.7844||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 208601\_s\_at||||0.7844
71109459|NCT01783444|141724344|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|0.64|||||TWO_SIDED|90.0|0.46|0.88||||||||0.88|0.46|
71109460|NCT01783444|141724344|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|1.33|||||TWO_SIDED|90.0|0.93|1.91||||||||1.91|0.93|
70852257|NCT04556383|141193030|SUPERIORITY||Risk Difference (RD)|-2.6||||0.6694|TWO_SIDED|95.0|-15.2|10.2|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||10.2|-15.2|0.6694
71059649|NCT03718832|141626347|SUPERIORITY||Mean Difference (Net)|-2.167034|STANDARD_ERROR_OF_MEAN|1.821244||0.234947|TWO_SIDED|95.0|-5.749627|1.415558||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||1.415558|-5.749627|0.234947
71059650|NCT03718832|141626348|SUPERIORITY||Mean Difference (Net)|-0.5561156|STANDARD_ERROR_OF_MEAN|1.086759||0.6091477|TWO_SIDED|95.0|-2.693002|1.58077||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||1.58077|-2.693002|0.6091477
71059651|NCT03718832|141626348|SUPERIORITY||Mean Difference (Net)|-0.3787962|STANDARD_ERROR_OF_MEAN|1.032547||0.713942|TWO_SIDED|95.0|-2.409379|1.651786||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||1.651786|-2.409379|0.713942
71109461|NCT01783444|141724345|OTHER||Mean Difference (Net)|4.3|||||TWO_SIDED|90.0|-3.3|11.9||||||Side-effects||11.9|-3.3|
71109462|NCT01783444|141724345|OTHER||Mean Difference (Net)|-2.2|||||TWO_SIDED|90.0|-9.9|5.5||||||Side-effects||5.5|-9.9|
71109463|NCT01783444|141724345|OTHER||Mean Difference (Net)|-3.3|||||TWO_SIDED|90.0|-10.4|3.8||||||Effectiveness||3.8|-10.4|
71109464|NCT01783444|141724345|OTHER||Mean Difference (Net)|-3.3|||||TWO_SIDED|90.0|-9.7|3.0||||||Effectiveness||3.0|-9.7|
71109465|NCT01783444|141724345|OTHER||Mean Difference (Net)|-1.6|||||TWO_SIDED|90.0|-5.8|2.5||||||Convenience||2.5|-5.8|
71109466|NCT01783444|141724345|OTHER||Mean Difference (Net)|-1.1|||||TWO_SIDED|90.0|-5.5|3.3||||||Convenience||3.3|-5.5|
71109467|NCT01783444|141724345|OTHER||Mean Difference (Net)|-2.7|||||TWO_SIDED|90.0|-8.3|2.9||||||Global Satisfaction||2.9|-8.3|
71109468|NCT01783444|141724345|OTHER||Mean Difference (Net)|-3.3|||||TWO_SIDED|90.0|-8.4|1.9||||||Global Satisfaction||1.9|-8.4|
70852258|NCT04556383|141193030|SUPERIORITY||Risk Difference (RD)|4.6||||0.4719|TWO_SIDED|95.0|-9.0|17.8|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||17.8|-9.0|0.4719
70852259|NCT04556383|141193032|SUPERIORITY||Risk Difference (RD)|-7.7||||0.3263|TWO_SIDED|95.0|-23.2|8.3|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||8.3|-23.2|0.3263
70852260|NCT04556383|141193032|SUPERIORITY||Risk Difference (RD)|10.2||||0.2002|TWO_SIDED|95.0|-6.1|25.8|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||25.8|-6.1|0.2002
71027182|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.4688||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 208601\_s\_at||||0.4688
70852261|NCT04556383|141193033|SUPERIORITY||Risk Difference (RD)|0.4||||0.9472|TWO_SIDED|95.0|-15.2|15.9|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||15.9|-15.2|0.9472
71027183|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.8553||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 208601\_s\_at||||0.8553
71027184|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.6926||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141\_at||||0.6926
71027185|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.2222||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141\_at||||0.2222
71027186|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.4676||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141\_at||||0.4676
71027187|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.2036||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372\_x\_at||||0.2036
71027188|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.4197||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372\_x\_at||||0.4197
71027189|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.0776||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372\_x\_at||||0.0776
71027190|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.4076||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023\_x\_at||||0.4076
71027191|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.0629||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023\_x\_at||||0.0629
71109469|NCT02722408|141724347|OTHER|||||||0.0041||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||||||0.0041
71109470|NCT02722408|141724348|OTHER|||||||0.001||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||||||0.0010
71027192|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.2547||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023\_x\_at||||0.2547
71027193|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.7125||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977\_x\_at||||0.7125
71109471|NCT02722408|141724349|OTHER|||||||0.0012||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||||||0.0012
70852262|NCT04556383|141193033|SUPERIORITY||Risk Difference (RD)|6.8||||0.3685|TWO_SIDED|95.0|-9.3|22.4|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||22.4|-9.3|0.3685
70852263|NCT04556383|141193034|SUPERIORITY||Risk Difference (RD)|1.3||||0.8484|TWO_SIDED|95.0|-12.7|15.2|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||15.2|-12.7|0.8484
71027194|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.6001||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977\_x\_at||||0.6001
71109472|NCT02722408|141724350|OTHER|||||||0.056||||||Mixed-effects model for repeated measures analysis with Change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0560
70852264|NCT04556383|141193034|SUPERIORITY||Risk Difference (RD)|8.2||||0.2392|TWO_SIDED|95.0|-6.4|22.3|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||22.3|-6.4|0.2392
70852265|NCT04556383|141193035|SUPERIORITY||Risk Difference (RD)|-1.2||||0.8493|TWO_SIDED|95.0|-14.8|12.5|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||12.5|-14.8|0.8493
70852266|NCT04556383|141193035|SUPERIORITY||Risk Difference (RD)|2.6||||0.6647|TWO_SIDED|95.0|-11.5|16.5|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||16.5|-11.5|0.6647
70935823|NCT00046475|141372710|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment global daily activity score as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||||||<0.001
70852267|NCT04556383|141193036|SUPERIORITY||Risk Difference (RD)|-6.5||||0.2263|TWO_SIDED|95.0|-19.1|6.0|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||6.0|-19.1|0.2263
71027195|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.5398||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977\_x\_at||||0.5398
71027196|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.397||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726\_x\_at||||0.3970
71027197|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.5085||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726\_x\_at||||0.5085
71027198|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.1213||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726\_x\_at||||0.1213
71027199|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.0999||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664\_at||||0.0999
71027200|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.1201||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664\_at||||0.1201
71027201|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.1172||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664\_at||||0.1172
71027202|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.6596||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191\_at||||0.6596
71027203|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.3289||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191\_at||||0.3289
71027204|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.3657||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191\_at||||0.3657
71109473|NCT02722408|141724350|OTHER|||||||0.0219||||||Mixed-effects model for repeated measures analysis with Change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0219
71109474|NCT02722408|141724350|OTHER|||||||0.0286||||||Mixed-effects model for repeated measures analysis with Change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0286
70852268|NCT04556383|141193036|SUPERIORITY||Risk Difference (RD)|-1.4||||0.8259|TWO_SIDED|95.0|-14.8|12.2|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||12.2|-14.8|0.8259
71027205|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.0275||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589\_at||||0.0275
71027206|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.3946||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589\_at||||0.3946
71027207|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.0074||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589\_at||||0.0074
71027208|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.2341||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684\_at||||0.2341
71027209|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.0933||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684\_at||||0.0933
71109475|NCT02722408|141724351|OTHER|||||||0.0058||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0058
71109476|NCT02722408|141724351|OTHER|||||||0.0019||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0019
70852269|NCT04556383|141193037|SUPERIORITY||Risk Difference (RD)|2.8||||0.7418|TWO_SIDED|95.0|-12.7|18.1|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||18.1|-12.7|0.7418
70852270|NCT04556383|141193037|SUPERIORITY||Risk Difference (RD)|8.4||||0.2758|TWO_SIDED|95.0|-7.8|24.2|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||24.2|-7.8|0.2758
71027210|NCT00455533|141561194|SUPERIORITY_OR_OTHER|||||||0.2016||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684\_at||||0.2016
71027211|NCT00455533|141561195|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|-0.145|||||TWO_SIDED|90.0|-0.27|-0.017|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Negative Biomarker Status||-0.017|-0.27|
71027212|NCT00455533|141561195|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|0.064|||||TWO_SIDED|90.0|-0.064|0.197|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Positive Biomarker STatus||0.197|-0.064|
71027213|NCT00455533|141561195|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|-0.056|||||TWO_SIDED|90.0|-0.152|0.046|||||ixabepilone - paclitaxel|Membrane Threshold/Negative Biomarker Status||0.046|-0.152|
71027214|NCT00455533|141561195|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|0.116|||||TWO_SIDED|90.0|-0.13|0.37|||||ixabepilone - paclitaxel|Membrane Threshold/Positive Biomarker Status||0.37|-0.13|
71027215|NCT00455533|141561196|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|-0.114|||||TWO_SIDED|90.0|-0.258|0.22|||||ixabepilone - paclitaxel|Mem+Cyto/Negative Biomarker Status||0.22|-0.258|
71027216|NCT00455533|141561196|SUPERIORITY_OR_OTHER||DIfference (bootstrap method)|0.009|||||TWO_SIDED|90.0|-0.137|0.155|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Positive Biomarker Status||0.155|-0.137|
71027217|NCT00455533|141561196|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|-0.058|||||TWO_SIDED|90.0|-0.167|0.053|||||ixabepilone - paclitaxel|Membrane Threshold/Negative Biomarker Status||0.053|-0.167|
71027218|NCT00455533|141561196|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|0.049|||||TWO_SIDED|90.0|-0.227|0.309|||||ixabepilone - paclitaxel|Membrane Threshold/Positive Biomarker Status||0.309|-0.227|
71027219|NCT00455533|141561197|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|-0.29|||||TWO_SIDED|90.0|-0.482|-0.094|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Negative Biomarker Status||-0.094|-0.482|
71027220|NCT00455533|141561197|SUPERIORITY_OR_OTHER||Difference (boostrap method)|0.106|||||TWO_SIDED|90.0|-0.073|0.291|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Positive Biomarker Status||0.291|-0.073|
71027221|NCT00455533|141561197|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|-0.09|||||TWO_SIDED|90.0|-0.236|0.067|||||ixabepilone - paclitaxel|Membrane Threshold/Negative Biomarker Status||0.067|-0.236|
71027222|NCT00455533|141561197|SUPERIORITY_OR_OTHER||Difference (bootsrap method)|0.117|||||TWO_SIDED|90.0|-0.218|0.469|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Positive Biomarker Status||0.469|-0.218|
71027223|NCT01048333|141561269|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.09||||0.002|TWO_SIDED|95.0|1.31|3.35|||Regression, Cox|||||3.35|1.31|0.002
71027224|NCT01048333|141561269|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|6.534||||0.001|TWO_SIDED|95.0|3.55|12.02|||Regression, Cox|||||12.02|3.55|0.001
71027225|NCT01048333|141561269|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.127||||0.001|TWO_SIDED|95.0|1.77|5.52|||Regression, Cox|||||5.52|1.77|0.001
71027226|NCT01396044|141561271|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.27
71027227|NCT01396044|141561272|SUPERIORITY_OR_OTHER|||||||0.093|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.093
71027228|NCT01396044|141561273|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|95.0|||||Chi-squared|||||||0.17
71027229|NCT01396044|141561274|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.27
71027230|NCT01396044|141561275|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.36
71027231|NCT01396044|141561277|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|95.0|||||Chi-squared|||||||0.002
71027232|NCT00955747|141561280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_DEVIATION|1.4|<|0.05|TWO_SIDED|95.0|||||ANCOVA|||All tests will be two-tailed. Unless specified otherwise, p-values less than or equal to O.050, when rounded to four decimal places,will be considered statistically significant.||||<0.05
71027233|NCT00539539|141561281|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.001||||0.96|TWO_SIDED|95.0|-0.04|0.05|||t-test, 2 sided|||Average change in cluster-specific rates of ROSC.||0.05|-0.04|0.96
71027234|NCT00539539|141561282|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.8||||0.71|TWO_SIDED|95.0|-4.9|3.4|||t-test, 2 sided|||Average difference in cluster-specific rates.||3.4|-4.9|0.71
71027235|NCT00539539|141561283|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.015||||0.21|TWO_SIDED|95.0|-0.039|0.009|||t-test, 2 sided|By-cluster difference in outcome rates.||Average change in cluster-specific risk difference.||0.009|-0.039|0.21
71027236|NCT00539539|141561284|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9||||0.016|TWO_SIDED|95.0|0.4|3.4|||Regression, Linear|Difference in means, adjusted for cluster.||Cluster adjusted difference in average CPR fraction.||3.4|0.4|0.016
71027237|NCT00539539|141561285|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.6||||0.005|TWO_SIDED|95.0|0.5|2.7|||Regression, Linear|Adjusted for randomization by cluster.||Cluster adjusted difference in means.||2.7|0.5|0.005
71027238|NCT00539539|141561286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7|||<|0.001|TWO_SIDED|95.0|-6.4|-3.0|||Regression, Linear|||Cluster adjusted difference in average compression rate.||-3.0|-6.4|<0.001
71027239|NCT00539539|141561287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.4|||<|0.001|TWO_SIDED|95.0|-5.2|-1.5|||Regression, Linear|||Cluster adjusted difference in the average rate.||-1.5|-5.2|<0.001
71027240|NCT00539539|141561288|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.73|TWO_SIDED|95.0|-0.5|0.7|||Regression, Linear|||Cluster adjusted difference in average rate.||0.7|-0.5|0.73
71027241|NCT00767325|141561291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.282|||TWO_SIDED|95.0|-1.2|-0.1|||||Day 7|||-0.1|-1.2|
71027242|NCT00767325|141561291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.308|||TWO_SIDED|95.0|-2.0|-0.7|||||Day 15|||-0.7|-2.0|
71027243|NCT00767325|141561291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|0.383|||TWO_SIDED|95.0|-3.2|-1.7|||||Day 29|||-1.7|-3.2|
71027244|NCT00767325|141561291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|0.384|||TWO_SIDED|95.0|-3.7|-2.1|||||Day 43|||-2.1|-3.7|
71027245|NCT00767325|141561291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.393|||TWO_SIDED|95.0|-4.0|-2.4|||||Day 57|||-2.4|-4.0|
71027246|NCT00767325|141561291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|0.454|||TWO_SIDED|95.0|-4.7|-2.9|||||Day 85|||-2.9|-4.7|
71027247|NCT00767325|141561291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5|STANDARD_ERROR_OF_MEAN|0.472|||TWO_SIDED|95.0|-5.4|-3.5|||||Day 113|||-3.5|-5.4|
71027248|NCT00767325|141561291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|0.492|||TWO_SIDED|95.0|-5.8|-3.8|||||Day 141|||-3.8|-5.8|
71109477|NCT02722408|141724351|OTHER|||||||0.0024||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0024
70852271|NCT04556383|141193038|SUPERIORITY||Risk Difference (RD)|-6.0||||0.3504|TWO_SIDED|95.0|-20.6|8.9|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||8.9|-20.6|0.3504
71109478|NCT02722408|141724352|OTHER|||||||0.0592||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0592
71109479|NCT02722408|141724352|OTHER|||||||0.0266||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0266
71109480|NCT02722408|141724352|OTHER|||||||0.0336||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0336
71109481|NCT02722408|141724353|OTHER|||||||0.0057||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0057
71109482|NCT02722408|141724353|OTHER|||||||0.0017||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0017
71109483|NCT02722408|141724353|OTHER|||||||0.0017||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0017
71109484|NCT02722408|141724354|OTHER|||||||0.0057||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0057
71109485|NCT02722408|141724354|OTHER|||||||0.0255||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0255
71109486|NCT02722408|141724354|OTHER|||||||0.0312||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 86||||0.0312
71109487|NCT02722408|141724355|OTHER|||||||0.4489||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.4489
71109488|NCT02722408|141724355|OTHER|||||||0.5964||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 84||||0.5964
71109489|NCT02722408|141724355|OTHER|||||||0.6785||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.6785
71109490|NCT02722408|141724356|OTHER|||||||0.2177||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300mg: Day 28||||0.2177
71109491|NCT02722408|141724356|OTHER|||||||0.3209||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600mg: Day 56||||0.3209
71109492|NCT02722408|141724356|OTHER|||||||0.3101||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900mg: Day 84||||0.3101
71109493|NCT02722408|141724357|OTHER|||||||0.0057||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0057
71109494|NCT02722408|141724357|OTHER|||||||0.0022||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0022
71109495|NCT02722408|141724357|OTHER|||||||0.0029||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0029
71109496|NCT02722408|141724358|OTHER|||||||0.0008||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300mg: Day 28||||0.0008
71109497|NCT02722408|141724358|OTHER|||||||0.0005||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600mg: Day 56||||0.0005
71027249|NCT00767325|141561291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|0.473|||TWO_SIDED|95.0|-5.8|-3.9|||||Day 169|||-3.9|-5.8|
70852272|NCT04556383|141193038|SUPERIORITY||Risk Difference (RD)|1.7||||0.8009|TWO_SIDED|95.0|-14.2|17.5|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||17.5|-14.2|0.8009
71059652|NCT03718832|141626348|SUPERIORITY||Mean Difference (Net)|0.4989275|STANDARD_ERROR_OF_MEAN|1.053869||0.6362064|TWO_SIDED|95.0|-1.573807|2.571662||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||2.571662|-1.573807|0.6362064
71059653|NCT03718832|141626348|SUPERIORITY||Mean Difference (Net)|1.146286|STANDARD_ERROR_OF_MEAN|1.048105||0.2748884|TWO_SIDED|95.0|-0.9154561|3.208027||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||3.208027|-0.9154561|0.2748884
71059654|NCT03718832|141626349|SUPERIORITY||Mean Difference (Net)|0.3232407|STANDARD_ERROR_OF_MEAN|0.3695066||0.3823224|TWO_SIDED|95.0|-0.4036366|1.050118||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||1.050118|-0.4036366|0.3823224
71059655|NCT03718832|141626349|SUPERIORITY||Mean Difference (Net)|0.2619965|STANDARD_ERROR_OF_MEAN|0.3729922||0.4829339|TWO_SIDED|95.0|-0.4718566|0.9958495||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.9958495|-0.4718566|0.4829339
71059656|NCT03718832|141626349|SUPERIORITY||Mean Difference (Net)|-0.6983982|STANDARD_ERROR_OF_MEAN|0.3476441||0.045506|TWO_SIDED|95.0|-1.382737|-0.0140597||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||-0.0140597|-1.382737|0.045506
71059657|NCT03718832|141626349|SUPERIORITY||Mean Difference (Net)|-0.6239824|STANDARD_ERROR_OF_MEAN|0.3336405||0.0625551|TWO_SIDED|95.0|-1.280906|0.0329412||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.0329412|-1.280906|0.0625551
71059658|NCT03718832|141626350|SUPERIORITY||Mean Difference (Net)|2.276579|STANDARD_ERROR_OF_MEAN|1.636162||0.1650343|TWO_SIDED|95.0|-0.9420086|5.495166||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||5.495166|-0.9420086|0.1650343
71059659|NCT03718832|141626350|SUPERIORITY||Mean Difference (Net)|1.989458|STANDARD_ERROR_OF_MEAN|1.359013||0.1442126|TWO_SIDED|95.0|-0.6843682|4.663284||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||4.663284|-0.6843682|0.1442126
71059660|NCT03718832|141626350|SUPERIORITY||Mean Difference (Net)|-1.579811|STANDARD_ERROR_OF_MEAN|0.739612||0.0335498|TWO_SIDED|95.0|-3.03574|-0.1238828||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment.||-0.1238828|-3.03574|0.0335498
71059661|NCT03718832|141626350|SUPERIORITY||Mean Difference (Net)|-1.764632|STANDARD_ERROR_OF_MEAN|0.8545352||0.0398937|TWO_SIDED|95.0|-3.447175|-0.0820899||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||-0.0820899|-3.447175|0.0398937
71059662|NCT03718832|141626351|SUPERIORITY||Mean Difference (Net)|-0.6294078|STANDARD_ERROR_OF_MEAN|0.4409795||0.1544491|TWO_SIDED|95.0|-1.496923|0.238107||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.238107|-1.496923|0.1544491
70852273|NCT04556383|141193039|SUPERIORITY||Risk Difference (RD)|-0.2||||0.9474|TWO_SIDED|95.0|-14.3|13.7|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||13.7|-14.3|0.9474
71059663|NCT03718832|141626351|SUPERIORITY||Mean Difference (Net)|-0.6081765|STANDARD_ERROR_OF_MEAN|0.451915||0.1793486|TWO_SIDED|95.0|-1.497352|0.2809987||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.2809987|-1.497352|0.1793486
71059664|NCT03718832|141626351|SUPERIORITY||Mean Difference (Net)|-0.1731023|STANDARD_ERROR_OF_MEAN|0.4024787||0.6674618|TWO_SIDED|95.0|-0.9653829|0.6191784||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.6191784|-0.9653829|0.6674618
71059665|NCT03718832|141626351|SUPERIORITY||Mean Difference (Net)|-0.2208031|STANDARD_ERROR_OF_MEAN|0.4196435||0.5992113|TWO_SIDED|95.0|-1.047063|0.6054567||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.6054567|-1.047063|0.5992113
71059666|NCT03718832|141626352|SUPERIORITY||Mean Difference (Net)|0.4824561|STANDARD_ERROR_OF_MEAN|0.423027||0.2549037|TWO_SIDED|95.0|-0.349686|1.314598||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||1.314598|-0.349686|0.2549037
70852274|NCT04556383|141193039|SUPERIORITY||Risk Difference (RD)|-3.0||||0.6409|TWO_SIDED|95.0|-16.6|10.8|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||10.8|-16.6|0.6409
71059667|NCT03718832|141626352|SUPERIORITY||Mean Difference (Net)|0.3545817|STANDARD_ERROR_OF_MEAN|0.4230741||0.4025977|TWO_SIDED|95.0|-0.4777863|1.186949||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||1.186949|-0.4777863|0.4025977
71059668|NCT03718832|141626352|SUPERIORITY||Mean Difference (Net)|-0.0102657|STANDARD_ERROR_OF_MEAN|0.4695747||0.9825739|TWO_SIDED|95.0|-0.9346107|0.9140792||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.9140792|-0.9346107|0.9825739
71059669|NCT03718832|141626352|SUPERIORITY||Mean Difference (Net)|-0.0340184|STANDARD_ERROR_OF_MEAN|0.4869778||0.9443607|TWO_SIDED|95.0|-0.9928399|0.9248032||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.9248032|-0.9928399|0.9443607
71109498|NCT02722408|141724358|OTHER|||||||0.0002||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900mg: Day 84||||0.0002
71109499|NCT02722408|141724359|OTHER|||||||0.4103||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.4103
71109500|NCT02722408|141724359|OTHER|||||||0.6164||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.6164
70852275|NCT04556383|141193040|SUPERIORITY||Risk Difference (RD)|-8.0||||0.1932|TWO_SIDED|95.0|-22.4|6.3|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||6.3|-22.4|0.1932
71027250|NCT02260492|141561317|EQUIVALENCE|"Equivalence test compares the Test/Reference with confidence bounds set at standard 80-125%.~Superiority test compares Test with Placebo (p\<0.05) Superiority test compares Reference with Placebo (p\<0.05) (p\<0.05)"|Test/Reference|1.0799|||<|0.05|TWO_SIDED|90.0|0.8|1.25|||ANCOVA|||"Primary analyses were conducted on BL subtracted values (pre-dose - post-dose). The two one-sided tests method of interval analysis is standard for bioequivalence testing and employs 2 sets of one-sided hypotheses as follows, performed at the 5% alpha level:~H01: uT-uR \< -0.20 uR vs. Ha1: -0.20 uR \</= uT- uR (the lower tail) and H02: uT-uR \>0.25 uR vs. Ha2: uT- uR \</=0.25 uR (the upper tail) When uT is the LSM SOLIS, uR is the LSM of ADVAIR DISKUS"|"Day 1 superiority to placebo:~Solis vs. Placebo p=0.004 Advair vs. Placebo p=0.012"|1.25|.8|<0.05
71027251|NCT02260492|141561318|EQUIVALENCE|Standard bioequivalence 90% confidence bounds set at 0.8-1.25.|Test/Reference|1.0475|||<|0.05|TWO_SIDED|90.0|0.8|1.25|||ANOVA|||Same as the Day 1 analyses|"Week 4 superiority to placebo:~Solis vs. Placebo p=0.019 Advair vs. Placebo p=0.035"|1.25|.8|<0.05
71027252|NCT00996736|141561321|NON_INFERIORITY_OR_EQUIVALENCE|The pre-specified non-inferiority margin is less than 1.5 lines logMAR acuity. (Adjusted three-month visual acuity confidence bounds for the difference between the voriconazole and natamycin groups which meet or exceed 0.15 logMAR units would not permit noninferiority to be declared.) Note that this design also allows declaration of superiority (2-sided alpha of 0.05, corrected for an interim analysis).|Mean Difference (Net)|-0.18||||0.006|TWO_SIDED|95.0|-0.3|-0.05|||Regression, Linear|||||-0.05|-0.30|0.006
71027253|NCT01497938|141561335|NON_INFERIORITY_OR_EQUIVALENCE|pre-specified non-inferiority margin of 0.4% was used for sample size calculation. sample size is based on two-sample t test with one-sided type 1 error of 2.5%. Assuming a same mean of change in A1C for the treatment arm and control arm and a common standard deviation of 1% for both treatment groups, it showed that a total of 200 subjects will provide over 80% power to detect the non-inferiority with a margin of 0.4%|Mean Difference (Final Values)|0.05|||||ONE_SIDED|97.5||0.15|||ANCOVA|||||0.15||
71027254|NCT01497938|141561336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-588.0|||<|0.025||95.0|||||ANCOVA|||||||<0.025
71027255|NCT00365352|141561337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.0015||95.0|-5.6|-1.3|||ANCOVA||Mean difference was adjusted for Baseline value, treatment pooled sites, and treatment by pool site interaction.|||-1.3|-5.6|0.0015
71027256|NCT00365352|141561338|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.287||||0.0001||95.0|2.338|7.861|||Regression, Logistic|A logistic regression model was used with treatment and pooled center as explanatory factors.||||7.861|2.338|0.0001
71027257|NCT01644890|141561397|NON_INFERIORITY|The primary PFS analysis was confirmed whether or not the upper limit of the 95% confidence interval (CI) for the hazard ratio (HR) for NK105 relative to PTX fell below the non-inferiority margin of 1.215 (\<1.215) by fitting a Cox proportional hazards model that included allocation adjustment factors other than the study site as covariates.|Hazard Ratio (HR)|1.255|||||TWO_SIDED|95.0|0.989|1.592|||||History of chemotherapy for metastatic or recurrent breast cancer (yes/no), History of treatment using a taxane anticancer drug (yes/no), ER status \[(+) or (-)\], and Disease free interval (\<12 months or ≥12 months) were covariates for adjustment.|Based on the results of previous studies, the expected median PFS was 5.5 months for PTX and 6.35 months for NK105. Assuming a randomization period of 18 months, a follow-up period of 12 months, a one-sided significance level of 2.5%, a power of 85% and the non-inferiority margin of 1.215, the number of patients was estimated to 172 pts per group, a total of 344 patients. Considering an expected withdrawal/dropout rate of approximately 20%, the target sample size was set at 414.||1.592|0.989|
71027258|NCT01644890|141561398|OTHER||Hazard Ratio (HR)|1.197|||||TWO_SIDED|95.0|0.885|1.62|||||History of chemotherapy for metastatic or recurrent breast cancer (yes/no), History of treatment using a taxane anticancer drug (yes/no), ER status \[(+) or (-)\], and Disease free interval (\<12 months or ≥12 months) were covariates for adjustment.|||1.620|0.885|
71027259|NCT01644890|141561399|OTHER||Difference in ORR (%)|-7.5|||||TWO_SIDED|95.0|-17.4|2.7||||||||2.7|-17.4|
71027260|NCT02761980|141561406|SUPERIORITY||LSM difference|3.14||||0.002|TWO_SIDED|95.0|1.13|5.15|||ANCOVA|||Treatment difference and 95 percent (%) confidence interval (CI) were based on Least Square Mean (LSM) from analysis of covariance (ANCOVA) with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.||5.15|1.13|0.002
71027261|NCT02761980|141561406|SUPERIORITY||LSM difference|0.91||||0.21|TWO_SIDED|95.0|-0.52|2.33|||ANCOVA|||Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.||2.33|-0.52|0.210
71027262|NCT02761980|141561406|SUPERIORITY||LSM difference|0.79||||0.28|TWO_SIDED|95.0|-0.64|2.21|||ANCOVA|||Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.||2.21|-0.64|0.280
71027263|NCT02761980|141561406|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|2.23||||0.03|TWO_SIDED|95.0|0.22|4.25|||ANCOVA|||||4.25|0.22|0.030
71027264|NCT02761980|141561406|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|2.35||||0.023|TWO_SIDED|95.0|0.33|4.37|||ANCOVA|||||4.37|0.33|0.023
71059670|NCT03718832|141626353|SUPERIORITY||Mean Difference (Net)|0.160997|STANDARD_ERROR_OF_MEAN|0.0376773||2.52e-05|TWO_SIDED|95.0|0.0868814|0.2351126||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.2351126|0.0868814|0.0000252
71059671|NCT03718832|141626353|SUPERIORITY||Mean Difference (Net)|0.1691707|STANDARD_ERROR_OF_MEAN|0.0391132||2.04e-05|TWO_SIDED|95.0|0.0922183|0.2461232||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.2461232|0.0922183|0.0000204
71059672|NCT03718832|141626353|SUPERIORITY||Mean Difference (Net)|0.0028595|STANDARD_ERROR_OF_MEAN|0.0261733||0.9130816|TWO_SIDED|95.0|-0.0486635|0.0543825||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.0543825|-0.0486635|0.9130816
71059673|NCT03718832|141626353|SUPERIORITY||Mean Difference (Net)|0.0166325|STANDARD_ERROR_OF_MEAN|0.0271062||0.5400053|TWO_SIDED|95.0|-0.0367394|0.0700045||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.0700045|-0.0367394|0.5400053
71059674|NCT03718832|141626354|SUPERIORITY||Mean Difference (Net)|0.0511555|STANDARD_ERROR_OF_MEAN|0.016316||0.0018721|TWO_SIDED|95.0|0.0190582|0.0832528||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.0832528|0.0190582|0.0018721
71059675|NCT03718832|141626354|SUPERIORITY||Mean Difference (Net)|0.0433081|STANDARD_ERROR_OF_MEAN|0.0168497||0.0106231|TWO_SIDED|95.0|0.0101555|0.0764607||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.0764607|0.0101555|0.0106231
71059676|NCT03718832|141626354|SUPERIORITY||Mean Difference (Net)|0.0138256|STANDARD_ERROR_OF_MEAN|0.0171112||0.4197898|TWO_SIDED|95.0|-0.0198584|0.0475096||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.0475096|-0.0198584|0.4197898
71059677|NCT03718832|141626354|SUPERIORITY||Mean Difference (Net)|0.0179852|STANDARD_ERROR_OF_MEAN|0.0171811||0.2961479|TWO_SIDED|95.0|-0.0158442|0.0518147||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.0518147|-0.0158442|0.2961479
71059678|NCT03718832|141626355|SUPERIORITY||Mean Difference (Net)|0.4018522|STANDARD_ERROR_OF_MEAN|0.1001575||7.43e-05|TWO_SIDED|95.0|0.2048311|0.5988733||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.5988733|0.2048311|0.0000743
71059679|NCT03718832|141626355|SUPERIORITY||Mean Difference (Net)|0.3643095|STANDARD_ERROR_OF_MEAN|0.1026922||0.0004471|TWO_SIDED|95.0|0.16227|0.566349||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.566349|0.16227|0.0004471
71109501|NCT02722408|141724359|OTHER|||||||0.6732||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.6732
71059680|NCT03718832|141626355|SUPERIORITY||Mean Difference (Net)|0.0006229|STANDARD_ERROR_OF_MEAN|0.1095781||0.9954683|TWO_SIDED|95.0|-0.2150785|0.2163243||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.2163243|-0.2150785|0.9954683
71059681|NCT03718832|141626355|SUPERIORITY||Mean Difference (Net)|-0.0161147|STANDARD_ERROR_OF_MEAN|0.1115322||0.8852268|TWO_SIDED|95.0|-0.2357129|0.2034834||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.2034834|-0.2357129|0.8852268
71109502|NCT02722408|141724360|OTHER|||||||0.2003||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300mg: Day 28||||0.2003
71109503|NCT02722408|141724360|OTHER|||||||0.3323||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600mg: Day 56||||0.3323
71109504|NCT02722408|141724360|OTHER|||||||0.3047||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900mg: Day 84||||0.3047
71109505|NCT02722408|141724361|OTHER|||||||0.3601||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.3601
71109506|NCT02722408|141724361|OTHER|||||||0.192||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.1920
71059682|NCT03718832|141626356|SUPERIORITY||Mean Difference (Net)|0.9013876|STANDARD_ERROR_OF_MEAN|0.4414753||0.0417413|TWO_SIDED|95.0|0.0338441|1.768931||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||1.768931|0.0338441|0.0417413
71059683|NCT03718832|141626356|SUPERIORITY||Mean Difference (Net)|0.8939751|STANDARD_ERROR_OF_MEAN|0.3896126||0.0222222|TWO_SIDED|95.0|0.1282798|1.65967||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||1.65967|0.1282798|0.0222222
71027265|NCT02761980|141561406|SUPERIORITY||LSM difference|-0.12||||0.864|TWO_SIDED|95.0|-1.54|1.29|||ANCOVA|||Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.||1.29|-1.54|0.864
71027266|NCT02761980|141561407|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.9||||0.004|TWO_SIDED|95.0|0.29|1.51|||ANCOVA|||WSTD 0-2 hours||1.51|0.29|0.004
71027267|NCT02761980|141561407|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.39||||0.078|TWO_SIDED|95.0|-0.04|0.82|||ANCOVA|||WSTD 0-2 hours||0.82|-0.04|0.078
70852276|NCT04556383|141193040|SUPERIORITY||Risk Difference (RD)|-2.3||||0.7459|TWO_SIDED|95.0|-17.6|12.9|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||12.9|-17.6|0.7459
71027268|NCT02761980|141561407|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.3||||0.172|TWO_SIDED|95.0|-0.13|0.74|||ANCOVA|||WSTD 0-2 hours||0.74|-0.13|0.172
71027269|NCT02761980|141561407|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.51||||0.098|TWO_SIDED|95.0|-0.1|1.13|||ANCOVA|||WSTD 0-2 hours||1.13|-0.10|0.098
71027270|NCT02761980|141561407|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.6||||0.054|TWO_SIDED|95.0|-0.01|1.21|||ANCOVA|||WSTD 0-2 hours||1.21|-0.01|0.054
71027271|NCT02761980|141561407|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|-0.09||||0.692|TWO_SIDED|95.0|-0.52|0.34|||ANCOVA|||WSTD 0-2 hours||0.34|-0.52|0.692
71027272|NCT02761980|141561407|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|1.87|||<|0.001|TWO_SIDED|95.0|0.86|2.88|||ANCOVA|||WSTD 0-4 hours||2.88|0.86|< 0.001
71027273|NCT02761980|141561407|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.61||||0.094|TWO_SIDED|95.0|-0.1|1.33|||ANCOVA|||WSTD 0-4 hours||1.33|-0.10|0.094
71027274|NCT02761980|141561407|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.45||||0.217|TWO_SIDED|95.0|-0.27|1.17|||ANCOVA|||WSTD 0-4 hours||1.17|-0.27|0.217
71027275|NCT02761980|141561407|SUPERIORITY||LSM difference|1.26||||0.015|TWO_SIDED|95.0|0.24|2.27||Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|ANCOVA|||WSTD 0-4 hours||2.27|0.24|0.015
71027276|NCT02761980|141561407|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|1.42||||0.006|TWO_SIDED|95.0|0.4|2.44|||ANCOVA|||WSTD 0-4 hours||2.44|0.40|0.006
71027277|NCT02761980|141561407|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|-0.16||||0.659|TWO_SIDED|95.0|-0.87|0.55|||ANCOVA|||WSTD 0-4 hours||0.55|-0.87|0.659
71027278|NCT02761980|141561407|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|2.62|||<|0.001|TWO_SIDED|95.0|1.16|4.08|||ANCOVA|||WSTD 0-6 hours||4.08|1.16|< 0.001
70852277|NCT00119678|141193044|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.7|1.5|||||Cox proportional-hazards model was used to estimate the hazard ratio of abatacept versus placebo for SLE disease flare. The 95% two-sided confidence interval was provided for the hazard ratio for treatment.|||1.5|0.7|
71027279|NCT02761980|141561407|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.79||||0.135|TWO_SIDED|95.0|-0.25|1.82|||ANCOVA|||WSTD 0-6 hours||1.82|-0.25|0.135
71027280|NCT02761980|141561407|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.7||||0.186|TWO_SIDED|95.0|-0.34|1.74|||ANCOVA|||WSTD 0-6 hours||1.74|-0.34|0.186
71027281|NCT02761980|141561407|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|1.83||||0.014|TWO_SIDED|95.0|0.37|3.29|||ANCOVA|||WSTD 0-6 hours||3.29|0.37|0.014
71027282|NCT02761980|141561407|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|1.92||||0.011|TWO_SIDED|95.0|0.45|3.39|||ANCOVA|||WSTD 0-6 hours||3.39|0.45|0.011
71027283|NCT02761980|141561407|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|-0.09||||0.865|TWO_SIDED|95.0|-1.12|0.94|||ANCOVA|||WSTD 0-6 hours||0.94|-1.12|0.865
71027284|NCT02761980|141561408|SUPERIORITY|||||||0.449||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank|||||||0.449
71027285|NCT02761980|141561408|SUPERIORITY|||||||0.142||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank|||||||0.142
71027286|NCT02761980|141561408|SUPERIORITY|||||||0.822||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank|||||||0.822
70852278|NCT02692391|141193070|SUPERIORITY|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
70852279|NCT02692391|141193071|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
70852280|NCT02692391|141193072|SUPERIORITY|||||||0.71|||||||Fisher Exact|||||||0.71
71027287|NCT02761980|141561408|SUPERIORITY|||||||0.671||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank|||||||0.671
71027288|NCT02761980|141561408|SUPERIORITY|||||||0.514||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank|||||||0.514
71027289|NCT02761980|141561408|SUPERIORITY|||||||0.191||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank|||||||0.191
71027290|NCT02761980|141561409|SUPERIORITY|||||||0.997||||||P-value, hazard ratio (HR) and corresponding 95% CI were calculated based on the proportional hazards (PH) model with treatment term in the model.|hazard ratio|||||||0.997
71027291|NCT02761980|141561409|SUPERIORITY|||||||0.998||||||P-value, HR and corresponding 95% CI were calculated based on the PH model with treatment term in the model.|Hazard Ratio|||||||0.998
71027292|NCT02761980|141561409|SUPERIORITY|||||||0.997||||||P-value, HR and corresponding 95% CI were calculated based on the PH model with treatment term in the model.|Hazard Ratio|||||||0.997
71027293|NCT02761980|141561410|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.67||||0.101|TWO_SIDED|95.0|-0.13|1.48|||ANCOVA|||||1.48|-0.13|0.101
71109507|NCT02722408|141724361|OTHER|||||||0.2912||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.2912
71109508|NCT02722408|141724361|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||<0.0001
71109509|NCT02722408|141724361|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||<0.0001
71109510|NCT02722408|141724361|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||<0.0001
71109511|NCT02722408|141724361|OTHER|||||||0.0444||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0444
71109512|NCT02722408|141724361|OTHER|||||||0.0159||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.0159
71109513|NCT02722408|141724361|OTHER|||||||0.0235||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0235
71109514|NCT02722408|141724361|OTHER|||||||0.0005||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0005
71027294|NCT02761980|141561410|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.16||||0.582|TWO_SIDED|95.0|-0.41|0.73|||ANCOVA|||||0.73|-0.41|0.582
71027295|NCT02761980|141561410|SUPERIORITY||LSM difference|0.15||||0.614|TWO_SIDED|95.0|-0.43|0.72|||ANCOVA|||Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.||0.72|-0.43|0.614
71027296|NCT02761980|141561410|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.51||||0.212|TWO_SIDED|95.0|-0.29|1.32|||ANCOVA|||||1.32|-0.29|0.212
71027297|NCT02761980|141561410|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.53||||0.202|TWO_SIDED|95.0|-0.28|1.34|||ANCOVA|||||1.34|-0.28|0.202
71027298|NCT02761980|141561410|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|-0.01||||0.965|TWO_SIDED|95.0|-0.58|0.55|||ANCOVA|||||0.55|-0.58|0.965
70852281|NCT02692391|141193073|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
70935824|NCT00046475|141372713|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||The P-value is based on an ANOVA model with change from baseline standing systolic blood pressure as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of standing systolic blood pressure||||0.002
71027299|NCT00101582|141561412|SUPERIORITY_OR_OTHER||Chi-Square Statistic|4.1764||||0.041||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants having no assessment were assumed as having WHO grade 3 or 4 oral mucositis in hypothesis testing.|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||Sample size calculations were based on the number of participants needed to detect, with 90% power and 5% type 1 error rate, at least a 25% difference in the incidence of severe OM between the treatment groups. A 25% absolute reduction in the incidence of severe OM from the placebo group was considered by investigators as clinically meaningful in this clinical setting.||||0.0410
71027300|NCT00101582|141561413|SUPERIORITY_OR_OTHER||Chi-Square Statistic|5.8002||||0.016||95.0||||Generalized Cochran-Mantel-Haenszel test for mean score difference.|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||||||0.0160
71027301|NCT00101582|141561413|SUPERIORITY_OR_OTHER|||||||0.1122||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel|||To protect the overall type 1 error, the Hochberg procedure was used to adjust for multiple statistical testing of the secondary efficacy endpoints.||||0.1122
71027302|NCT00101582|141561414|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6603||||0.0261|TWO_SIDED|95.0|0.4546|0.9592|||Stratified Log-Rank test|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).|Hazard ratio of palifermin over placebo based on Stratified Cox proportional hazard model.|||0.9592|0.4546|0.0261
71027303|NCT00101582|141561414|SUPERIORITY_OR_OTHER|||||||0.1566||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Stratified Log-Rank test|||||||0.1566
71027304|NCT00101582|141561415|SUPERIORITY_OR_OTHER||Chi-Square Statistic|3.9715||||0.0463||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants having no assessment were assumed to have the event.|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||||||0.0463
71027305|NCT00101582|141561415|SUPERIORITY_OR_OTHER|||||||0.2314||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel|||||||0.2314
71027306|NCT00101582|141561416|SUPERIORITY_OR_OTHER||Chi-Square Statistic|3.2548||||0.0712||95.0||||Generalized Cochran-Mantel-Haenszel test for mean score difference using modified ridit score|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||||||0.0712
71027307|NCT00101582|141561416|SUPERIORITY_OR_OTHER|||||||0.2849||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel|||||||0.2849
71027308|NCT00101582|141561417|SUPERIORITY_OR_OTHER||Chi-Square Statistic|1.3901||||0.2384||95.0||||Generalized Cochran-Mantel-Haenszel test for mean score difference using modified ridit score.|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||||||0.2384
71027309|NCT00101582|141561417|SUPERIORITY_OR_OTHER|||||||0.6835||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel|||||||0.6835
71027310|NCT00101582|141561418|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.9039||||0.3417||95.0||||Generalized Cochran-Mantel-Haenszel test for general association|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||||||0.3417
71027311|NCT00101582|141561418|SUPERIORITY_OR_OTHER|||||||0.6835||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel|||||||0.6835
71027312|NCT00101582|141561419|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.0027||||0.9587||95.0||||Generalized Cochran-Mantel-Haenszel test for general association.|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||||||0.9587
71109515|NCT02722408|141724361|OTHER|||||||0.0003||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0003
71109516|NCT02722408|141724361|OTHER|||||||0.0003||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0003
71027313|NCT00101582|141561419|SUPERIORITY_OR_OTHER|||||||0.9587||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel|||||||0.9587
71027314|NCT03093324|141561426|SUPERIORITY||Rate ratio|0.542||||0.0003|TWO_SIDED|95.0|0.39|0.754|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||0.754|0.390|0.0003
71027315|NCT03093324|141561427|SUPERIORITY||Rate ratio|0.52||||0.0007|TWO_SIDED|95.0|0.356|0.76|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||0.760|0.356|0.0007
71027316|NCT03093324|141561428|SUPERIORITY||Rate ratio|0.714||||0.009|TWO_SIDED|95.0|0.554|0.921|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||0.921|0.554|0.009
71027317|NCT03093324|141561429|SUPERIORITY||Rate ratio|0.555||||0.009|TWO_SIDED|95.0|0.357|0.862|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||0.862|0.357|0.009
70852282|NCT00509145|141193105|SUPERIORITY||Risk Ratio (RR)|0.77|STANDARD_ERROR_OF_MEAN|0.066||0.0024|TWO_SIDED|95.0|0.65|0.911|||Over-dispersed Poisson Regression||Laquinimod 0.6 mg vs. placebo|Response variable: number of relapses during 24 months. Offset based on the log of subject's exposure in years was employed to adjust for variability of treatment exposure. In addition to the treatment group, the Poisson regression model included the following covariates: baseline EDSS score, log of prior 2-year number of relapses+1 and Country or Geographical Region (CGR).||0.911|0.650|0.0024
71059684|NCT03718832|141626356|SUPERIORITY||Mean Difference (Net)|0.0276596|STANDARD_ERROR_OF_MEAN|0.7606961||0.9710103|TWO_SIDED|95.0|-1.467185|1.522504||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||1.522504|-1.467185|0.9710103
71059685|NCT03718832|141626356|SUPERIORITY||Mean Difference (Net)|0.0377244|STANDARD_ERROR_OF_MEAN|0.6523585||0.9539117|TWO_SIDED|95.0|-1.244338|1.319787||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||1.319787|-1.244338|0.9539117
71059686|NCT03718832|141626357|SUPERIORITY||Mean Difference (Net)|-0.1045328|STANDARD_ERROR_OF_MEAN|0.1417549||0.4612408|TWO_SIDED|95.0|-0.3830955|0.1740299||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.1740299|-0.3830955|0.4612408
71059687|NCT03718832|141626357|SUPERIORITY||Mean Difference (Net)|-0.0552724|STANDARD_ERROR_OF_MEAN|0.1181649||0.6401864|TWO_SIDED|95.0|-0.2874987|0.176954||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.176954|-0.2874987|0.6401864
71059688|NCT03718832|141626357|SUPERIORITY||Mean Difference (Net)|-0.2761332|STANDARD_ERROR_OF_MEAN|0.2593125||0.2874913|TWO_SIDED|95.0|-0.7857084|0.2334419||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.2334419|-0.7857084|0.2874913
71059689|NCT03718832|141626357|SUPERIORITY||Mean Difference (Net)|-0.155843|STANDARD_ERROR_OF_MEAN|0.2092772||0.4568601|TWO_SIDED|95.0|-0.56713|0.2554439||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.2554439|-0.56713|0.4568601
71059690|NCT03718832|141626358|SUPERIORITY||Mean Difference (Net)|0.0539315|STANDARD_ERROR_OF_MEAN|0.0267347||0.0442418|TWO_SIDED|95.0|0.0013953|0.1064678||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.1064678|0.0013953|0.0442418
71059691|NCT03718832|141626358|SUPERIORITY||Mean Difference (Net)|0.0546574|STANDARD_ERROR_OF_MEAN|0.0272506||0.0454857|TWO_SIDED|95.0|0.0011025|0.1082124||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.1082124|0.0011025|0.0454857
71059692|NCT03718832|141626358|SUPERIORITY||Mean Difference (Net)|0.0076781|STANDARD_ERROR_OF_MEAN|0.0188378||0.683764|TWO_SIDED|95.0|-0.0293401|0.0446963||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.0446963|-0.0293401|0.683764
71059693|NCT03718832|141626358|SUPERIORITY||Mean Difference (Net)|0.0053342|STANDARD_ERROR_OF_MEAN|0.0183059||0.7708852|TWO_SIDED|95.0|-0.0306419|0.0413103||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.0413103|-0.0306419|0.7708852
71059694|NCT03718832|141626359|SUPERIORITY||Mean Difference (Net)|-0.053099|STANDARD_ERROR_OF_MEAN|0.0436586||0.2245167|TWO_SIDED|95.0|-0.1388926|0.0326946||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.0326946|-0.1388926|0.2245167
71059695|NCT03718832|141626359|SUPERIORITY||Mean Difference (Net)|-0.0815933|STANDARD_ERROR_OF_MEAN|0.0424438||0.0551913|TWO_SIDED|95.0|-0.1650069|0.0018204||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.0018204|-0.1650069|0.0551913
71059696|NCT03718832|141626359|SUPERIORITY||Mean Difference (Net)|-0.0506938|STANDARD_ERROR_OF_MEAN|0.0461078||0.2721373|TWO_SIDED|95.0|-0.1413002|0.0399126||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.0399126|-0.1413002|0.2721373
71109517|NCT02722408|141724362|OTHER|||||||0.3646||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.3646
71109518|NCT02722408|141724362|OTHER|||||||0.1994||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.1994
71109519|NCT02722408|141724362|OTHER|||||||0.2858||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.2858
71109520|NCT02722408|141724362|OTHER|||||||0.0829||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.0829
71059697|NCT03718832|141626359|SUPERIORITY||Mean Difference (Net)|-0.079563|STANDARD_ERROR_OF_MEAN|0.0428514||0.0640071|TWO_SIDED|95.0|-0.1637776|0.0046516||Adjusted mean difference for full controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.0046516|-0.1637776|0.0640071
70852283|NCT01994889|141193110|SUPERIORITY|||||||0.0006|||||||Finkelstein-Schoenfeld Method|||||||0.0006
71027318|NCT03093324|141561430|SUPERIORITY||Rate ratio|0.696||||0.033|TWO_SIDED|95.0|0.499|0.972|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||0.972|0.499|0.033
71027319|NCT03093324|141561431|SUPERIORITY||Rate ratio|0.662||||0.068|TWO_SIDED|95.0|0.425|1.031|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||1.031|0.425|0.068
71059698|NCT03718832|141626360|SUPERIORITY||Mean Difference (Net)|13.79692|STANDARD_ERROR_OF_MEAN|808.862||0.9864081|TWO_SIDED|95.0|-1581.244|1608.838||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||1608.838|-1581.244|0.9864081
71059699|NCT03718832|141626360|SUPERIORITY||Mean Difference (Net)|119.3302|STANDARD_ERROR_OF_MEAN|885.2058||0.8929133|TWO_SIDED|95.0|-1627.128|1865.789||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||1865.789|-1627.128|0.8929133
71059700|NCT03718832|141626360|SUPERIORITY||Mean Difference (Net)|-1260.452|STANDARD_ERROR_OF_MEAN|1327.743||0.343724|TWO_SIDED|95.0|-3880.298|1359.393||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||1359.393|-3880.298|0.343724
71059701|NCT03718832|141626360|SUPERIORITY||Mean Difference (Net)|-1206.216|STANDARD_ERROR_OF_MEAN|1344.574||0.3709654|TWO_SIDED|95.0|-3860.887|1448.455||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||1448.455|-3860.887|0.3709654
71059702|NCT03718832|141626361|SUPERIORITY||Mean Difference (Net)|1290.605|STANDARD_ERROR_OF_MEAN|732.2306||0.0795087|TWO_SIDED|95.0|-153.3215|2734.532||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||2734.532|-153.3215|0.0795087
71059703|NCT03718832|141626361|SUPERIORITY||Mean Difference (Net)|1207.762|STANDARD_ERROR_OF_MEAN|874.6068||0.1689786|TWO_SIDED|95.0|-517.7854|2933.309||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||2933.309|-517.7854|0.1689786
71027320|NCT03093324|141561432|SUPERIORITY||Rate ratio|0.713||||0.215|TWO_SIDED|95.0|0.417|1.217|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||1.217|0.417|0.215
71059704|NCT03718832|141626361|SUPERIORITY||Mean Difference (Net)|1209.35|STANDARD_ERROR_OF_MEAN|957.1006||0.2080145|TWO_SIDED|95.0|-679.1596|3097.86||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||3097.86|-679.1596|0.2080145
71059705|NCT03718832|141626361|SUPERIORITY||Mean Difference (Net)|1258.587|STANDARD_ERROR_OF_MEAN|1077.807||0.2445904|TWO_SIDED|95.0|-869.3893|3386.563||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||3386.563|-869.3893|0.2445904
70852284|NCT01994889|141193111|SUPERIORITY||Hazard Ratio (HR)|0.698||||0.0259|TWO_SIDED|95.0|0.508|0.958|||Cox proportional hazards model||Hazard ratio from a Cox proportional hazards model with treatment, TTR genotype (variant and wild-type) and New York Heart Association (NYHA) baseline classification (NYHA Classes I and II combined and NYHA Class III) in the model.|||0.958|0.508|0.0259
70941726|NCT04748445|141383935|OTHER||Slope|-0.000156|STANDARD_ERROR_OF_MEAN|6.763||0.818|TWO_SIDED|90.0|-0.001277|0.0009647|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 03 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0009647|-0.001277|0.8180
71059706|NCT03718832|141626362|SUPERIORITY||Mean Difference (Net)|2.035245|STANDARD_ERROR_OF_MEAN|0.1415551|<|0.001|TWO_SIDED|95.0|1.757075|2.313415||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||2.313415|1.757075|<0.001
71059707|NCT03718832|141626362|SUPERIORITY||Mean Difference (Net)|2.0087|STANDARD_ERROR_OF_MEAN|0.1395364|<|0.001|TWO_SIDED|95.0|1.734473|2.282927||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||2.282927|1.734473|<0.001
70935825|NCT00046475|141372713|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED|||||The P-value is based on an ANOVA model with change from baseline standing diastolic blood pressure as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of standing diastolic blood pressure||||0.010
70935826|NCT00046475|141372714|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with change from baseline supine systolic blood pressure as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of supine systolic blood pressure||||<0.001
70935827|NCT00046475|141372714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||The P-value is based on an ANOVA model with change from baseline supine diastolic blood pressure as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of supine diastolic blood pressure||||0.002
70935828|NCT00046475|141372715|SUPERIORITY_OR_OTHER_LEGACY|||||||0.569|TWO_SIDED|||||The P-value is based on an ANOVA model with SF-36 general health score as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of general health||||0.569
70935829|NCT00046475|141372715|SUPERIORITY_OR_OTHER_LEGACY|||||||0.578|TWO_SIDED|||||The P-value is based on an ANOVA model with SF-36 physical functioning score as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of physical functioning||||0.578
70935830|NCT00046475|141372719|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|TWO_SIDED|||||The p-value is based on an ANOVA model with post-treatment responses for OHSA Item 1 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and subject-within sequence as random effect.|ANOVA|||Analysis of US participants with mild or moderate disease severity||||0.370
70935831|NCT00046475|141372720|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|TWO_SIDED|||||The p-value is based on an ANOVA model with post-treatment responses for OHSA Item 1 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and subject-within sequence as random effect.|ANOVA|||Analysis of US participants with marked or severe disease severity||||0.007
70935832|NCT02203032|141372733|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Row mean score test|||||||< 0.001
70935833|NCT02203032|141372734|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Row mean score test|||||||< 0.001
70935834|NCT02203032|141372735|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Row mean score test|||||||< 0.001
71027321|NCT03093324|141561433|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.043|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||Nausea: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.||-0.0|-0.6|0.043
71027322|NCT03093324|141561433|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.7|-0.2|||ANCOVA|||Vomiting: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.||-0.2|-0.7|<0.001
71027323|NCT03093324|141561433|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.16||0.001|TWO_SIDED|95.0|-0.9|-0.2|||ANCOVA|||Upper Abdominal Pain: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.||-0.2|-0.9|0.001
71027324|NCT03093324|141561433|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.403|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||Lower Abdominal Pain: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.||0.2|-0.4|0.403
71027325|NCT03093324|141561433|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.261|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Diarrhea: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.||0.2|-0.6|0.261
70852285|NCT01994889|141193112|SUPERIORITY||Risk Ratio (RR)|0.6761|||<|0.0001|TWO_SIDED|95.0|0.5639|0.8107||Poisson regression analysis with treatment, TTR genotype, NYHA baseline classification, treatment-by-TTR genotype interaction, and treatment-by-NYHA baseline classification interaction terms as factors adjusted for treatment duration.|Poisson regression analysis|||||0.8107|0.5639|<0.0001
70935835|NCT02203032|141372736|SUPERIORITY_OR_OTHER||||||=|0.001|||||||Cochran-Mantel-Haenszel|||||||= 0.001
70935836|NCT01915914|141372737|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|13.4993|||<|0.0001|TWO_SIDED|95.0|4.1113|44.325|||Log Rank|||||44.3250|4.1113|<0.0001
70935837|NCT01915914|141372738|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.9524|||<|0.0001|TWO_SIDED|95.0|2.4258|10.1105|||Log Rank|||||10.1105|2.4258|<0.0001
70935838|NCT01915914|141372739|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
70935839|NCT01915914|141372740|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
70935840|NCT01915914|141372742|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
70935841|NCT01915914|141372743|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
70935842|NCT01915914|141372748|SUPERIORITY_OR_OTHER|||||||0.701||95.0||||Week 20, CA|Wilcoxon (Mann-Whitney)|||||||0.7010
70935843|NCT01915914|141372748|SUPERIORITY_OR_OTHER|||||||0.0042||95.0||||Week 20, ET/L|Wilcoxon (Mann-Whitney)|||||||0.0042
70935844|NCT01915914|141372748|SUPERIORITY_OR_OTHER|||||||0.081||95.0||||Week 20, AP|Wilcoxon (Mann-Whitney)|||||||0.0810
70935845|NCT01915914|141372748|SUPERIORITY_OR_OTHER|||||||0.2799||95.0||||Week 32, CA|Wilcoxon (Mann-Whitney)|||||||0.2799
70935846|NCT01915914|141372748|SUPERIORITY_OR_OTHER|||||||0.1375||95.0||||Week 32, ET/L|Wilcoxon (Mann-Whitney)|||||||0.1375
70935847|NCT01915914|141372748|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||Week 32, AP|Wilcoxon (Mann-Whitney)|||||||0.1100
70935848|NCT01915914|141372748|SUPERIORITY_OR_OTHER|||||||0.0394||95.0||||Week 20, Total VAS Score|Wilcoxon (Mann-Whitney)|||||||0.0394
70935849|NCT01915914|141372748|SUPERIORITY_OR_OTHER|||||||0.2237||95.0||||Week 32, Total VAS Score|Wilcoxon (Mann-Whitney)|||||||0.2237
70935850|NCT01213940|141372771|EQUIVALENCE|95% confidence limit from standard deviation of mean|||||<|0.05|||||||ANOVA|||one -way ANOVA was used for the analysis||||<0.05
70935851|NCT02725372|141372780|SUPERIORITY||Mean Difference (Final Values)|1.99||||0.87|TWO_SIDED|95.0|-22.47|26.45|||Mixed Models Analysis|||||26.45|-22.47|0.87
70935852|NCT02725372|141372781|SUPERIORITY|||||||0.55|||||||Log Rank|||||||0.55
70935853|NCT02725372|141372783|SUPERIORITY||Mean Difference (Final Values)|-89.1||||0.01|TWO_SIDED|95.0|-156.0|-22.1|||ANCOVA|||||-22.1|-156.0|0.01
71027326|NCT04583579|141561435|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
71027327|NCT00976664|141561440|SUPERIORITY_OR_OTHER|||||||0.0007|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Group differences in VAS for low back pain from randomization visit to 6-week visit were assessed via the Wilcoxon rank sums test.||||||.0007
71027328|NCT00976664|141561440|SUPERIORITY_OR_OTHER|||||||0.3913|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Group differences in VAS for low back pain from randomization visit to 12-week visit were assessed via the Wilcoxon rank sums test.||||||.3913
71027329|NCT00976664|141561441|SUPERIORITY_OR_OTHER|||||||0.002|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Group differences in ODI for low back pain from randomization visit to 6-week visit were assessed using the Wilcoxon rank sums test.||||||.002
71027330|NCT00976664|141561441|SUPERIORITY_OR_OTHER|||||||0.0336|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Group differences in ODI for low back pain from randomization visit to 12-week visit were assessed using the Wilcoxon rank sums test.||||||.0336
71027331|NCT00135707|141561442|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07||||0.42|TWO_SIDED|95.0|0.91|1.25|||Chi-squared|||The primary hypothesis states that antioxidant therapy initiated prior to 16 weeks gestation in women will reduce the frequency of serious maternal and infant complications associated with pregnancy related hypertension. We estimated that with a sample size of 10,000 women, the study would have 90% power to show a 30% reduction in the rate of the primary outcome, from 4% in the placebo to 2.8% in the vitamin group, with a two-sided type I error rate of 5%.||1.25|0.91|0.42
71027332|NCT00135707|141561443|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||0.79|TWO_SIDED|95.0|0.85|1.24|||Chi-squared|||||1.24|0.85|0.79
71027333|NCT00135707|141561444|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79||||0.35|TWO_SIDED|95.0|0.47|1.31|||Chi-squared|||||1.31|0.47|0.35
71027334|NCT00135707|141561445|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.68||||0.16|TWO_SIDED|95.0|0.39|1.17|||Chi-squared|||||1.17|0.39|0.16
71027335|NCT00135707|141561446|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.63||||0.34|TWO_SIDED|95.0|0.25|1.63|||Chi-squared|||||1.63|0.25|0.34
71027336|NCT00135707|141561447|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.49||||0.11|TWO_SIDED|95.0|0.78|7.94|||Chi-squared|||||7.94|0.78|0.11
71027337|NCT00135707|141561448|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81||||0.57|TWO_SIDED|95.0|0.39|1.68|||Chi-squared|||||1.68|0.39|0.57
71027338|NCT00135707|141561449|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.18|TWO_SIDED|95.0|0.89|1.9|||Chi-squared|||||1.90|0.89|0.18
71027339|NCT00135707|141561450|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.09||||0.84|TWO_SIDED|95.0|0.48|2.46|||Chi-squared|||||2.46|0.48|0.84
71027340|NCT00135707|141561451|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07||||0.33|TWO_SIDED|95.0|0.93|1.24|||Chi-squared|||||1.24|0.93|0.33
71027341|NCT00135707|141561452|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.004|TWO_SIDED|95.0|1.03|1.17|||Chi-squared|||||1.17|1.03|0.004
71027342|NCT00135707|141561453|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07||||0.25|TWO_SIDED|95.0|0.95|1.21|||Chi-squared|||||1.21|0.95|0.25
71027343|NCT00135707|141561454|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.73||||0.15||95.0|0.47|1.12|||Chi-squared|||||1.12|0.47|0.15
71027344|NCT00135707|141561455|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75||||0.51|TWO_SIDED|95.0|0.32|1.77|||Chi-squared|||||1.77|0.32|0.51
71027345|NCT00135707|141561456|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.21||||0.33|TWO_SIDED|95.0|0.82|1.79|||Chi-squared|||||1.79|0.82|0.33
71027346|NCT00135707|141561457|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96||||0.74|TWO_SIDED|95.0|0.75|1.22|||Chi-squared|||||1.22|0.75|0.74
71027347|NCT00135707|141561458|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.66||||0.12|TWO_SIDED|95.0|0.4|1.11|||Chi-squared|||||1.11|0.40|0.12
71027348|NCT00135707|141561459|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||0.35|TWO_SIDED|95.0|0.97|1.11|||Chi-squared|||||1.11|0.97|0.35
71027349|NCT00135707|141561461|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3||||0.05|TWO_SIDED|95.0|0.08|1.08|||Chi-squared|||||1.08|0.08|0.05
71027350|NCT00135707|141561462|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.67||||0.05|TWO_SIDED|95.0|0.45|1.01|||Chi-squared|||||1.01|0.45|0.05
71027351|NCT00135707|141561463|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.65
71027352|NCT00135707|141561464|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.21
71027353|NCT00135707|141561465|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.97||||0.63|TWO_SIDED|95.0|0.87|1.09|||Chi-squared|||\<37 weeks' gestation||1.09|0.87|0.63
71027354|NCT00135707|141561465|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.86||||0.16|TWO_SIDED|95.0|0.69|1.06|||Chi-squared|||\<32 weeks' gestation||1.06|0.69|0.16
71027355|NCT00135707|141561466|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92||||0.53|TWO_SIDED|95.0|0.72|1.19|||Chi-squared|||||1.19|0.72|0.53
71027356|NCT00135707|141561467|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.55
71027357|NCT00135707|141561468|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.98|TWO_SIDED|95.0|0.79|1.27|||Chi-squared|||||1.27|0.79|0.98
71027358|NCT00135707|141561469|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.93||||0.32|TWO_SIDED|95.0|0.81|1.07|||Chi-squared|||||1.07|0.81|0.32
71027359|NCT00135707|141561470|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||0.58|TWO_SIDED|95.0|0.92|1.15|||Chi-squared|||||1.15|0.92|0.58
71027360|NCT00135707|141561471|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.04||||0.75|TWO_SIDED|95.0|0.83|1.3|||Chi-squared|||||1.30|0.83|0.75
71027361|NCT00135707|141561472|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.85||||0.78|TWO_SIDED|95.0|0.29|2.54|||Chi-squared|||||2.54|0.29|0.78
71027362|NCT00135707|141561473|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.34|TWO_SIDED|95.0|0.76|2.23|||Chi-squared|||||2.23|0.76|0.34
71027363|NCT00135707|141561474|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.71||||0.41|TWO_SIDED|95.0|0.32|1.6|||Chi-squared|||||1.60|0.32|0.41
71027364|NCT00135707|141561475|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.18||||0.62|TWO_SIDED|95.0|0.61|2.3|||Chi-squared|||||2.30|0.61|0.62
71027365|NCT00135707|141561476|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.85||||0.56|TWO_SIDED|95.0|0.49|1.48|||Chi-squared|||||1.48|0.49|0.56
70935854|NCT02725372|141372784|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.47|TWO_SIDED|95.0|-0.89|0.41|||ANCOVA|||||0.41|-0.89|0.47
71027366|NCT00135707|141561477|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.79
71027367|NCT00135707|141561478|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02||||0.86|TWO_SIDED|95.0|0.82|1.26|||Chi-squared|||||1.26|0.82|0.86
71059708|NCT03718832|141626362|SUPERIORITY||Mean Difference (Net)|1.619982|STANDARD_ERROR_OF_MEAN|0.2663507|<|0.001|TWO_SIDED|95.0|1.096575|2.143388||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment.||2.143388|1.096575|<0.001
71059709|NCT03718832|141626362|SUPERIORITY||Mean Difference (Net)|1.559642|STANDARD_ERROR_OF_MEAN|0.2680774|<|0.001|TWO_SIDED|95.0|1.032797|2.086488||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment.||2.086488|1.032797|<0.001
71059710|NCT03718832|141626363|SUPERIORITY||Mean Difference (Net)|1.881776|STANDARD_ERROR_OF_MEAN|0.1057965|<|0.001|TWO_SIDED|95.0|1.673875|2.089677||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment.||2.089677|1.673875|<0.001
71027368|NCT00135707|141561479|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.12||||0.32|TWO_SIDED|95.0|0.89|1.42|||Chi-squared|||||1.42|0.89|0.32
71027369|NCT02743702|141561501|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71027370|NCT03679741|141561531|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|1.9|STANDARD_DEVIATION|1.99|||TWO_SIDED|95.0|-1.9|5.8|||Bayesian multivariate normal random-effe|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as test minus control|It was calculated that 30 participants randomized in a 1:1 fashion between the two lens wear sequences would have at least 80% power to detect a 5 point difference between the test and control lenses with respect to overall comfort at the 2-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05).||5.8|-1.9|
71027371|NCT03679741|141561532|NON_INFERIORITY|A cumulative odds ratio non-inferiority margin of 0.67 was used. This margin is based on no more than a 10% difference in proportion between the Test and the Control lenses. The odds ratio represents the cumulative odds ratio of having a higher rating/experience of the Test lens compared to the Control lens.|Odds Ratio (OR)|3.97|STANDARD_DEVIATION|1.138|||TWO_SIDED|95.0|2.27|6.62|||Bayesian multinomial random-effects mode|A 95% Credible Interval for the odds ratio, was used to test for non-inferiority.|Odds ratio was calculated as test over control|||6.62|2.27|
71027372|NCT03679741|141561533|NON_INFERIORITY|A non-inferiority margin of 0.05 logMAR was used. This margin corresponds to a half line difference. Non-inferiority was declared if the upper bound of the 95% credible interval was below 0.05 logMAR.|Mean Difference (Final Values)|-0.022|STANDARD_DEVIATION|0.0074|||TWO_SIDED|95.0|-0.037|-0.008|||Bayesian multivariate normal model|with random effects|Mean difference was calculated as Test minus Control|It was calculated that 4 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect non-inferiority with respect to visual acuity (logMAR) at the 2-week follow-up. Sample size was determined using Stroup's method. The analysis presented below, summarizes the low luminance high contrast lighting condition.||-0.008|-0.037|
71027373|NCT03679741|141561533|NON_INFERIORITY|A non-inferiority margin of 0.05 logMAR was used. This margin corresponds to a half line difference. Non-inferiority was declared if the upper bound of the 95% credible interval was below 0.05 logMAR.|Mean Difference (Final Values)|-0.034|STANDARD_DEVIATION|0.0075|||TWO_SIDED|95.0|-0.049|-0.02|||Bayesian multivariate normal model|with random effect|Mean difference was calculated as Test minus Control|It was calculated that 4 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect non-inferiority with respect to visual acuity (logMAR) at the 2-week follow-up. Sample size was determined using Stroup's method. The analysis presented below, summarizes the high illumination low contrast lighting condition.||-0.020|-0.049|
71027374|NCT03679741|141561534|SUPERIORITY|A superiority margin of 90% was used. Superiority was concluded if the lower limit of the 95% credible interval was above 90%|Mean Percentage of eyes|100.0|STANDARD_DEVIATION|0.002|||TWO_SIDED|95.0|99.0|100.0|||Bayesian beta- binomial model|for correlated binary data||It was calculated that 65 participants were required to show that the acceptable lens fitting for the Test lens would be superior to 90% with at least 80% power. Sample size was determined using simulations methods for repeated measures.||100.0|99.0|
71027375|NCT03679741|141561535|NON_INFERIORITY|A non-inferiority cumulative odds ratio margin of 2 was used. This margin corresponds to no more than a 5% difference between the Test and Control lenses assuming the Control reference rate does not exceed 5%. Non-inferiority was declared if the upper bound of the 95% credible interval was below 2.|Mean Difference (Final Values)|0.001|STANDARD_DEVIATION|0.003|||TWO_SIDED|95.0|-0.004|0.008|||Bayesian beta-binomial hierarchical||Mean difference was calculated as Test minus Control.|It was calculated that 50 participants randomized in a 1:1 fashion between the two lens wear sequences would have at least 80% power to detect 5% difference between the Test and Control lens with respect to the proportion of eyes with Grade 3 or higher slit lamp findings across all study visits. Sample size was determined using simulations methods.||0.008|-0.004|
71059711|NCT03718832|141626363|SUPERIORITY||Mean Difference (Net)|1.868221|STANDARD_ERROR_OF_MEAN|0.1036609|<|0.001|TWO_SIDED|95.0|1.664499|2.071943||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment.||2.071943|1.664499|<0.001
70935855|NCT02725372|141372785|SUPERIORITY||Odds Ratio (OR)|1.05||||0.26|TWO_SIDED|95.0|0.48|2.29|||Cochran-Mantel-Haenszel|||||2.29|0.48|0.26
70941727|NCT04748445|141383935|OTHER||Slope|-0.0000971|STANDARD_ERROR_OF_MEAN|6.18||0.8754|TWO_SIDED|90.0|-0.001121|0.000927|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4.||0.0009270|-0.001121|0.8754
70941728|NCT04748445|141383935|OTHER||Slope|0.000452|STANDARD_ERROR_OF_MEAN|5.576||0.4192|TWO_SIDED|90.0|-0.0004721|0.001376|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 05 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001376|-0.0004721|0.4192
71027376|NCT03679741|141561536|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|5.6|STANDARD_DEVIATION|1.29|||TWO_SIDED|95.0|3.1|8.1|||Bayesian multivariate normal model|for random effects|Mean difference was calculated as test minus control|Sample size was based on primary endpoints only.||8.1|3.1|
71027377|NCT03679741|141561537|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|2.5|STANDARD_DEVIATION|1.56|||TWO_SIDED|95.0|-0.6|5.5|||Bayesian multivariate normal model|for random effects|Mean difference was calculated as test minus control|Sample size was based on primary endpoints only.||5.5|-0.6|
71027378|NCT03679741|141561538|NON_INFERIORITY|A cumulative odds ratio non-inferiority margin of 0.67 was used. This margin is based on no more than a 10% difference in proportion between the Test and the Control lenses. The odds ratio represents the cumulative odds ratio of having a higher rating/experience of the Test lens compared to the Control lens.|Odds Ratio (OR)|1.73|STANDARD_DEVIATION|0.459|||TWO_SIDED|95.0|1.0|2.82|||Bayesian multinomial random-effects|A 95% Credible Interval for the odds ratio, was used to test for non-inferiority.|Odds ratio was calculated as test over control|||2.82|1.00|
71027379|NCT02584140|141561563|OTHER||||||<|0.001||||||The P-Value for Week 4 was \<0.001; The P-Value for Week 12 was 0.005; The P-Value for Week 24 was 0.029; The P-Value for Week 36 was 0.008; The P-Value for Week 48 was 0.03.|Wilcoxon (Mann-Whitney)|||||||<0.001
71027380|NCT00368966|141561587|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) greater than (\>) -10%.|Difference|-0.6||||||95.0|-2.9|1.6||||||For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥ 1:8 threshold was calculated||1.6|-2.9|
71027381|NCT00368966|141561587|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|1.2||||||95.0|-2.3|4.9||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥ 0.10 IU/mL threshold was calculated||4.9|-2.3|
71027382|NCT00368966|141561587|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.3|1.3||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥ 0.01 IU/mL threshold was calculated||1.3|-1.3|
71027383|NCT00368966|141561588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for immune response induced by Meningitec was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.72||||||95.0|0.6|0.86||||||For Meningococcal C the GMT ratio (13vPnC/7vPnC) was calculated||0.86|0.60|
71027384|NCT00368966|141561589|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for immune response induced by Meningitec was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.81||||||95.0|0.7|0.94||||||For Diphtheria the GMC ratio (13vPnC/7vPnC) was calculated||0.94|0.70|
71027385|NCT00368966|141561592|SUPERIORITY_OR_OTHER||Difference|1.23||||||95.0|1.13|1.35||||||For serotype 4, the Geometric Mean fold Rise (GMFR) were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.35|1.13|
71027386|NCT00368966|141561592|SUPERIORITY_OR_OTHER||Difference|9.28||||||95.0|8.18|10.53||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||10.53|8.18|
71027387|NCT00368966|141561592|SUPERIORITY_OR_OTHER||Difference|1.15||||||95.0|1.05|1.25||||||For serotype 6B, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.25|1.05|
71027388|NCT00368966|141561592|SUPERIORITY_OR_OTHER||Difference|1.61||||||95.0|1.41|1.83||||||For serotype 14, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.83|1.41|
71027389|NCT00368966|141561592|SUPERIORITY_OR_OTHER||Difference|1.45||||||95.0|1.3|1.61||||||For serotype 18C, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.61|1.30|
71027390|NCT00368966|141561592|SUPERIORITY_OR_OTHER||Difference|0.93||||||95.0|0.83|1.03||||||For serotype 19F, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.03|0.83|
71027391|NCT00368966|141561592|SUPERIORITY_OR_OTHER||Difference|4.0||||||95.0|3.55|4.5||||||For serotype 23F, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||4.50|3.55|
71027392|NCT00368966|141561592|SUPERIORITY_OR_OTHER||Difference|1.6||||||95.0|1.46|1.76||||||For serotype 1, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.76|1.46|
71027393|NCT00368966|141561592|SUPERIORITY_OR_OTHER||Difference|1.23||||||95.0|1.13|1.35||||||For serotype 3, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.35|1.13|
71027394|NCT00368966|141561592|SUPERIORITY_OR_OTHER||Difference|1.94||||||95.0|1.78|2.11||||||For serotype 5, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||2.11|1.78|
71027395|NCT00368966|141561592|SUPERIORITY_OR_OTHER||Difference|2.87||||||95.0|2.58|3.2||||||For serotype 6A, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||3.20|2.58|
71027396|NCT00368966|141561592|SUPERIORITY_OR_OTHER||Difference|2.18||||||95.0|1.98|2.41||||||For serotype 7F, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||2.41|1.98|
71027397|NCT00368966|141561592|SUPERIORITY_OR_OTHER||Difference|1.3||||||95.0|1.18|1.44||||||For serotype 19A, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.44|1.18|
71027398|NCT00368966|141561593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.3|1.3||||||For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 EU/mL threshold was calculated||1.3|-1.3|
71027399|NCT00368966|141561593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.9||||||95.0|-6.0|2.0||||||For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 20 EU/mL threshold was calculated||2.0|-6.0|
71027400|NCT00368966|141561593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.3|1.3||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 EU/mL threshold was calculated||1.3|-1.3|
71027401|NCT00368966|141561593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.3|1.3||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 7.82 EU/mL threshold was calculated||1.3|-1.3|
71027402|NCT00368966|141561593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.3||||||95.0|-5.2|2.6||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 64 EU/mL threshold was calculated||2.6|-5.2|
71027403|NCT00368966|141561593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.3|1.3||||||For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated||1.3|-1.3|
71027404|NCT00368966|141561593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.6||||||95.0|-4.4|3.2||||||For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 39 EU/mL threshold was calculated||3.2|-4.4|
71027405|NCT00368966|141561593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|1.7||||||For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 EU/mL threshold was calculated||1.7|-1.7|
71027406|NCT00368966|141561593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.4||||||95.0|-5.1|2.2||||||For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 11 EU/mL threshold was calculated||2.2|-5.1|
71027407|NCT00368966|141561593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 EU/mL threshold was calculated||1.4|-1.4|
71027408|NCT00368966|141561593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 7.82 EU/mL threshold was calculated||1.4|-1.4|
71027409|NCT00368966|141561593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.6||||||95.0|-4.6|3.3||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 99 EU/mL threshold was calculated||3.3|-4.6|
71027410|NCT00368966|141561593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated||1.4|-1.4|
71027411|NCT00368966|141561593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.7||||||95.0|-5.8|2.3||||||For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 69 EU/mL threshold was calculated||2.3|-5.8|
71027412|NCT00368966|141561593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.7|||||TWO_SIDED|95.0|-2.5|0.7||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.10 IU/mL threshold was calculated||0.7|-2.5|
71027413|NCT00368966|141561593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.3|1.3||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated||1.3|-1.3|
71027414|NCT00368966|141561593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.8|||||TWO_SIDED|95.0|-2.8|0.8||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.10 IU/mL threshold was calculated||0.8|-2.8|
71027415|NCT00368966|141561593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.5|1.5||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated||1.5|-1.5|
71109521|NCT02722408|141724362|OTHER|||||||0.0492||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.0492
70935856|NCT01075152|141372786|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.73||||0.03|TWO_SIDED|95.0|1.06|2.82||A Lan-DeMets spending function analog of the O'Brien-Fleming boundaries was proposed to control the type-I error resulting from multiple interim analyses.|Regression, Cox||Hazard Ratio describes the risk of earlier HIV therapy in comparison to deferred HIV therapy initiation as the reference group.|"We compared the randomization arms for the primary endpoint of survival using time-to-event methods of Cox proportional hazards models by the intention-to-treat principle, based on two-sided type-I error with alpha=0.05.~The trial was statistically powered to detect a 25% relative survival benefit (15% absolute benefit) with 90% power and overall two-sided alpha=0.05 with an intended sample size of 500 participants. The trial was halted early by the Data and Safety Monitoring Board."||2.82|1.06|0.03
70935857|NCT01075152|141372787|SUPERIORITY_OR_OTHER_LEGACY|||||||0.32|||||||Gray's method of cumulative incidence|||To account for the competing risk of death, the cumulative incidence function compared the randomized groups for endpoints of IRIS, relapse, and adverse events (Gray's method).||||0.32
70935858|NCT01075152|141372788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06|||||||Gray's method of cumulative incidence|||To account for the competing risk of death, the cumulative incidence function compared the randomized groups for endpoints of IRIS, relapse, and adverse events (Gray's method).||||0.06
71027416|NCT00368966|141561593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.4|||||TWO_SIDED|95.0|-2.1|2.9||||||For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.10 IU/mL threshold was calculated||2.9|-2.1|
71027417|NCT00368966|141561593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.3|1.3||||||For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated||1.3|-1.3|
71027418|NCT00368966|141561593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.8|||||TWO_SIDED|95.0|-2.1|3.8||||||For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.10 IU/mL threshold was calculated||3.8|-2.1|
71027419|NCT00368966|141561593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.8|1.7||||||For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated||1.7|-1.8|
71027420|NCT00368966|141561593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.4|1.3||||||For Poliovirus Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated||1.3|-1.4|
71027421|NCT00368966|141561593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.7|||||TWO_SIDED|95.0|-0.6|2.6||||||For Poliovirus Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated||2.6|-0.6|
71027422|NCT00368966|141561593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.4|||||TWO_SIDED|95.0|-1.0|2.0||||||For Poliovirus Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated||2.0|-1.0|
71027423|NCT00368966|141561593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.5|1.5||||||For Poliovirus Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 EU/mL threshold was calculated||1.5|-1.5|
71027424|NCT00368966|141561593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.4|||||TWO_SIDED|95.0|-1.1|2.2||||||For Poliovirus Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 EU/mL threshold was calculated||2.2|-1.1|
71027425|NCT00368966|141561593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.5|1.5||||||For Poliovirus Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 EU/mL threshold was calculated||1.5|-1.5|
71027426|NCT00368966|141561594|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.0||||||95.0|0.82|1.23||||||For Poliovirus Type 1 the GMT ratio (13vPnC/7vPnC) was calculated||1.23|0.82|
70935859|NCT01075152|141372789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98|||||||Fisher Exact|||Categorical secondary endpoints were compared with Fisher's exact tests.||||0.98
70935860|NCT01075152|141372790|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.66||||0.04|TWO_SIDED|95.0|1.03|2.68|||Regression, Cox|||We compared the randomization arms for survival using time-to-event methods of Cox proportional hazards models.||2.68|1.03|0.04
71027427|NCT00368966|141561594|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.94||||||95.0|0.76|1.18||||||For Poliovirus Type 2 the GMT ratio (13vPnC/7vPnC) was calculated||1.18|0.76|
71109522|NCT02722408|141724362|OTHER|||||||0.0442||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.0442
70935861|NCT01075152|141372791|SUPERIORITY_OR_OTHER_LEGACY|||||||0.26|||||||Fisher Exact|||Categorical secondary endpoints were compared with Fisher's exact tests.||||0.26
70935862|NCT01075152|141372792|SUPERIORITY_OR_OTHER_LEGACY|||||||0.23|||||||Fisher Exact|||Categorical secondary endpoints were compared with Fisher's exact tests.||||0.23
70935863|NCT01075152|141372793|SUPERIORITY_OR_OTHER_LEGACY|||||||0.34|||||||repeated measure analysis|||The overall change from baseline in Karnofsky performance status scores was compared between groups via a repeated measure analysis, unstructured covariance matrix, adjusted for baseline value.||||0.34
71027428|NCT00368966|141561594|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.95||||||95.0|0.76|1.19||||||For Poliovirus Type 3 the GMT ratio (13vPnC/7vPnC) was calculated||1.19|0.76|
71027429|NCT00368966|141561594|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.82||||||95.0|0.69|0.98||||||For Poliovirus Type 1 the GMT ratio (13vPnC/7vPnC) was calculated||0.98|0.69|
71027430|NCT00368966|141561594|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.9||||||95.0|0.75|1.09||||||For Poliovirus Type 2 the GMT ratio (13vPnC/7vPnC) was calculated||1.09|0.75|
71027431|NCT00368966|141561594|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.07||||||95.0|0.88|1.29||||||For Poliovirus Type 3 the GMT ratio (13vPnC/7vPnC) was calculated||1.29|0.88|
71027432|NCT00368966|141561595|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.85||||||95.0|0.75|0.96||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||0.96|0.75|
71027433|NCT00368966|141561595|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.03||||||95.0|0.88|1.2||||||For Tetanus the GMC ratio (13vPnC/7vPnC) was calculated||1.20|0.88|
71027434|NCT00368966|141561595|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.86||||||95.0|0.71|1.02||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||1.02|0.71|
71027435|NCT00368966|141561595|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.12||||||95.0|0.9|1.4||||||For Tetanus the GMC ratio (13vPnC/7vPnC) was calculated||1.40|0.90|
71027436|NCT00368966|141561596|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.03||||||95.0|0.93|1.13||||||For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated||1.13|0.93|
71027437|NCT00368966|141561596|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.07||||||95.0|0.96|1.2||||||For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated||1.20|0.96|
71027438|NCT00368966|141561596|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.05||||||95.0|0.92|1.18||||||For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated||1.18|0.92|
71027439|NCT00368966|141561596|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.0||||||95.0|0.88|1.14||||||For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated||1.14|0.88|
71027440|NCT00368966|141561596|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.01||||||95.0|0.88|1.15||||||For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated||1.15|0.88|
71027441|NCT00368966|141561596|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.89||||||95.0|0.78|1.02||||||For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated||1.02|0.78|
71027442|NCT00368966|141561597|SUPERIORITY_OR_OTHER||Difference|2.2||||||95.0|0.1|4.4||||||For serotype 4, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||4.4|0.1|
71027443|NCT00368966|141561597|SUPERIORITY_OR_OTHER||Difference|41.2||||||95.0|34.9|46.9||||||For serotype 6B, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||46.9|34.9|
71027444|NCT00368966|141561597|SUPERIORITY_OR_OTHER||Difference|7.3||||||95.0|4.1|10.4||||||For serotype 9V, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||10.4|4.1|
71027445|NCT00368966|141561597|SUPERIORITY_OR_OTHER||Difference|-1.1||||||95.0|-3.4|1.2||||||For serotype 14, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||1.2|-3.4|
71027446|NCT00368966|141561597|SUPERIORITY_OR_OTHER||Difference|6.4||||||95.0|3.1|9.5||||||For serotype 18C, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||9.5|3.1|
71027447|NCT00368966|141561597|SUPERIORITY_OR_OTHER||Difference|1.5||||||95.0|-0.4|3.4||||||For serotype 19F, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||3.4|-0.4|
71027448|NCT00368966|141561597|SUPERIORITY_OR_OTHER||Difference|26.5||||||95.0|20.7|31.9||||||For serotype 23F, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||31.9|20.7|
71027449|NCT00368966|141561597|SUPERIORITY_OR_OTHER||Difference|3.0||||||95.0|0.8|5.1||||||For serotype 1, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||5.1|0.8|
71109523|NCT02722408|141724362|OTHER|||||||0.736||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.7360
71027450|NCT00368966|141561597|SUPERIORITY_OR_OTHER||Difference|2.2||||||95.0|-1.8|6.3||||||For serotype 3, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||6.3|-1.8|
71027451|NCT00368966|141561597|SUPERIORITY_OR_OTHER||Difference|10.0||||||95.0|5.9|13.9||||||For serotype 5, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||13.9|5.9|
71027452|NCT00368966|141561597|SUPERIORITY_OR_OTHER||Difference|13.0||||||95.0|8.6|17.2||||||For serotype 6A, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||17.2|8.6|
71027453|NCT00368966|141561597|SUPERIORITY_OR_OTHER||Difference|1.5||||||95.0|-0.1|3.1||||||For serotype 7F, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||3.1|-0.1|
71027454|NCT00368966|141561597|SUPERIORITY_OR_OTHER||Difference|1.5||||||95.0|-0.4|3.4||||||For serotype 19A, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||3.4|-0.4|
71027455|NCT01694485|141561605|SUPERIORITY|The study was powered for formal statistical testing of the abrilumab 70 mg and 210 mg groups. To account for multiplicity of statistical testing, primary and key secondary end points for the 2 highest doses of abrilumab (70 and 210 mg) were tested at the end of the 8-week induction period under a sequential framework at a 2-sided significance level of 0.10 using the Bonferroni-based chain procedure.|Odds Ratio (OR)|3.35||||0.021|TWO_SIDED|90.0|1.41|7.95|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||7.95|1.41|0.021
71027456|NCT01694485|141561605|SUPERIORITY||Difference in Adjusted Remission Rates|9.0|||||TWO_SIDED|90.0|1.6|14.6||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||14.6|1.6|
71027457|NCT01694485|141561605|SUPERIORITY|The study was powered for formal statistical testing of the abrilumab 70 mg and 210 mg groups. To account for multiplicity of statistical testing, primary and key secondary end points for the 2 highest doses of abrilumab (70 and 210 mg) were tested at the end of the 8-week induction period under a sequential framework at a 2-sided significance level of 0.10 using the Bonferroni-based chain procedure.|Odds Ratio (OR)|3.33||||0.03|TWO_SIDED|90.0|1.34|8.26|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||8.26|1.34|0.030
71027458|NCT01694485|141561605|SUPERIORITY||Difference in Adjusted Remission Rates|8.9|||||TWO_SIDED|90.0|0.8|14.9||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||14.9|0.8|
71059712|NCT03718832|141626363|SUPERIORITY||Mean Difference (Net)|1.650879|STANDARD_ERROR_OF_MEAN|0.2057239|<|0.001|TWO_SIDED|95.0|1.246611|2.055147||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment.||2.055147|1.246611|<0.001
71059713|NCT03718832|141626363|SUPERIORITY||Mean Difference (Net)|1.636306|STANDARD_ERROR_OF_MEAN|0.2052192|<|0.001|TWO_SIDED|95.0|1.232994|2.039618||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment.||2.039618|1.232994|<0.001
71059714|NCT03718832|141626364|SUPERIORITY||Mean Difference (Net)|0.1104533|STANDARD_ERROR_OF_MEAN|0.0769621||0.1519153|TWO_SIDED|95.0|-0.040785|0.2616915||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment.||0.2616915|-0.040785|0.1519153
71059715|NCT03718832|141626364|SUPERIORITY||Mean Difference (Net)|0.0594575|STANDARD_ERROR_OF_MEAN|0.0654489||0.3641254|TWO_SIDED|95.0|-0.0691675|0.1880824||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment.||0.1880824|-0.0691675|0.3641254
71109524|NCT02722408|141724362|OTHER|||||||0.6917||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.6917
71109525|NCT02722408|141724362|OTHER|||||||0.7131||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.7131
71109526|NCT02722408|141724362|OTHER|||||||0.0014||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0014
71109527|NCT02722408|141724362|OTHER|||||||0.0009||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0009
71109528|NCT02722408|141724362|OTHER|||||||0.0007||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0007
71109529|NCT02722408|141724363|OTHER|||||||0.388||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.3880
71027459|NCT01694485|141561605|SUPERIORITY|Comparisons of abrilumab 21 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.64||||0.64|TWO_SIDED|90.0|0.13|3.17|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.17|0.13|0.64
71027460|NCT01694485|141561605|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Remission Rates|-1.6|||||TWO_SIDED|90.0|-5.2|5.5||||||The difference in remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||5.5|-5.2|
71027461|NCT01694485|141561605|SUPERIORITY|Comparisons of abrilumab 7 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.34||||0.49|TWO_SIDED|90.0|0.03|4.33|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.33|0.03|0.49
71027462|NCT01694485|141561605|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Remission Rates|-2.9|||||TWO_SIDED|90.0|-5.5|5.4||||||The difference in remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||5.4|-5.5|
71027463|NCT01694485|141561606|SUPERIORITY|If both comparisons of the primary endpoint reached statistical significance at 0.10, results from the 2 key secondary endpoints (response and mucosal healing at week 8) were to be sequentially (70 mg vs placebo then 210 mg vs placebo) tested at significance level of 0.05 independently of each other, according to the Bonferroni-based chain procedure.|Odds Ratio (OR)|2.78|||<|0.001|TWO_SIDED|90.0|1.71|4.52|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.52|1.71|<0.001
71027464|NCT01694485|141561606|SUPERIORITY||Difference in Adjusted Response Rates|23.4|||||TWO_SIDED|90.0|11.8|33.2||||||The difference in adjusted response rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||33.2|11.8|
71027465|NCT01694485|141561606|SUPERIORITY|If both comparisons of the primary endpoint reached statistical significance at 0.10, results from the 2 key secondary endpoints (response and mucosal healing at week 8) were to be sequentially (70 mg vs placebo then 210 mg vs placebo) tested at significance level of 0.05 independently of each other, according to the Bonferroni-based chain procedure.|Odds Ratio (OR)|2.57||||0.003|TWO_SIDED|90.0|1.53|4.31|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.31|1.53|0.003
71027466|NCT01694485|141561606|SUPERIORITY||Difference in Adjusted Response Rates|21.4|||||TWO_SIDED|90.0|9.0|31.8||||||The difference in adjusted response rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||31.8|9.0|
71027467|NCT01694485|141561606|SUPERIORITY|Comparisons of abrilumab 21 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|2.54||||0.024|TWO_SIDED|90.0|1.29|5.02|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||5.02|1.29|0.024
71027468|NCT01694485|141561606|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Response Rates|21.2|||||TWO_SIDED|90.0|4.9|34.1||||||The difference in adjusted response rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||34.1|4.9|
71059716|NCT03718832|141626364|SUPERIORITY||Mean Difference (Net)|0.2062905|STANDARD_ERROR_OF_MEAN|0.1288363||0.1100186|TWO_SIDED|95.0|-0.0468859|0.4594669||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment.||0.4594669|-0.0468859|0.1100186
71059717|NCT03718832|141626364|SUPERIORITY||Mean Difference (Net)|0.1162375|STANDARD_ERROR_OF_MEAN|0.1015839||0.2531303|TWO_SIDED|95.0|-0.0834025|0.3158775||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment.||0.3158775|-0.0834025|0.2531303
71059718|NCT03718832|141626365|SUPERIORITY||Mean Difference (Net)|-0.0584644|STANDARD_ERROR_OF_MEAN|0.040837||0.152918|TWO_SIDED|95.0|-0.1387132|0.0217844||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.0217844|-0.1387132|0.152918
70935864|NCT01075152|141372794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44|||||||Regression, Linear|a linear mixed effects regression model fit with a random intercept and slope estimated the rate of clearance||To describe early fungicidal activity, a linear mixed effects regression model fit with a random intercept and slope estimated the rate of clearance of log10 colony forming units (CFU) of Cryptococcus, per mL of CSF per day, for all participants with \>2 cultures obtained.||||0.44
71027469|NCT01694485|141561606|SUPERIORITY|Comparisons of abrilumab 7 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.4||||0.18|TWO_SIDED|90.0|0.13|1.22|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||1.22|0.13|0.18
71027470|NCT01694485|141561606|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Response Rates|-13.7|||||TWO_SIDED|90.0|-24.4|2.7||||||The difference in adjusted response rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||2.7|-24.4|
71027471|NCT01694485|141561607|SUPERIORITY|If both comparisons of the primary endpoint reached statistical significance at 0.10, results from the 2 key secondary endpoints (response and mucosal healing at week 8) were to be sequentially (70 mg vs placebo then 210 mg vs placebo) tested at significance level of 0.05 independently of each other, according to the Bonferroni-based chain procedure.|Odds Ratio (OR)|2.34||||0.011|TWO_SIDED|90.0|1.35|4.07|||Regression, Logistic|Adjusted for baseline rectosigmoidoscopy score and stratification factors.|An odds ratio \> 1.0 indicates a higher healing rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using healing rates estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.07|1.35|0.011
71027472|NCT01694485|141561607|SUPERIORITY||Difference in Adjusted Healing Rates|15.3|||||TWO_SIDED|90.0|4.8|24.0||||||The difference in adjusted healing rates, estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||24.0|4.8|
71027473|NCT01694485|141561607|SUPERIORITY|If both comparisons of the primary endpoint reached statistical significance at 0.10, results from the 2 key secondary endpoints (response and mucosal healing at week 8) were to be sequentially (70 mg vs placebo then 210 mg vs placebo) tested at significance level of 0.05 independently of each other, according to the Bonferroni-based chain procedure.|Odds Ratio (OR)|2.1||||0.041|TWO_SIDED|90.0|1.15|3.82|||Regression, Logistic|Adjusted for baseline rectosigmoidoscopy score and stratification factors|An odds ratio \> 1.0 indicates a higher healing rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using healing rates from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.82|1.15|0.041
71027474|NCT01694485|141561607|SUPERIORITY||Difference in Adjusted Healing Rates|13.0|||||TWO_SIDED|90.0|1.7|22.1||||||The difference in adjusted healing rates, estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||22.1|1.7|
71027475|NCT01694485|141561607|SUPERIORITY|Comparisons of abrilumab 21 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.8||||0.68|TWO_SIDED|90.0|0.32|1.97|||Regression, Logistic|Adjusted for baseline rectosigmoidoscopy score and stratification factors|An odds ratio \> 1.0 indicates a higher healing rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using healing rates from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||1.97|0.32|0.68
71027476|NCT01694485|141561607|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Healing Rates|-3.0|||||TWO_SIDED|90.0|-11.9|9.4||||||The difference in adjusted healing rates, estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||9.4|-11.9|
71059719|NCT03718832|141626365|SUPERIORITY||Mean Difference (Net)|-0.0585771|STANDARD_ERROR_OF_MEAN|0.0304262||0.0548344|TWO_SIDED|95.0|-0.1183728|0.0012186||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment.||0.0012186|-0.1183728|0.0548344
71059720|NCT03718832|141626365|SUPERIORITY||Mean Difference (Net)|-0.1691027|STANDARD_ERROR_OF_MEAN|0.0673022||0.0123238|TWO_SIDED|95.0|-0.3013583|-0.036847||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment.||-0.036847|-0.3013583|0.0123238
71059721|NCT03718832|141626365|SUPERIORITY||Mean Difference (Net)|-0.1701425|STANDARD_ERROR_OF_MEAN|0.0575065||0.0032534|TWO_SIDED|95.0|-0.2831584|-0.0571266||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment.||-0.0571266|-0.2831584|0.0032534
71059722|NCT03288714|141626385|SUPERIORITY|||||||0.814|||||||Fisher Exact|The proportion of patients is compared across treatment groups using Fisher's Exact.||Null hypothesis is that the active sTMS treatment group does not differ from the sham group with respect to the proportion of patients with clinical response at Week 6.||||.814
71059723|NCT03288714|141626386|SUPERIORITY|||||||0.872|||||||ANCOVA|P-value is from analysis of covariance adjusting for baseline.||Null hypothesis is that the active sTMS treatment group does not differ from the sham group with respect to the proportion of patients with clinical response at Week 6.||||.872
71059724|NCT03288714|141626387|SUPERIORITY|||||||0.641|||||||ANCOVA|P-value is from analysis of covariance adjusting for baseline.||The null hypothesis is that the active sTMS treatment group does not differ||||.641
71059725|NCT03288714|141626388|SUPERIORITY|||||||0.032||||||Alpha level: .05|ANCOVA|P-value is from analysis of covariance adjusting for baseline||||||.032
70935865|NCT01075152|141372795|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||||||This is the interaction p-value for CSF white cell count at randomization (implying there is a statistical difference in the outcome by arm based on this parameter).|Regression, Cox|||Pre-specified subgroups formed by baseline characteristics were compared for 26 week survival with models including an interaction term between treatment arm and subgroup.||||0.02
71027477|NCT01694485|141561607|SUPERIORITY|Comparisons of abrilumab 7 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.69||||0.6|TWO_SIDED|90.0|0.21|2.22|||Regression, Logistic|Adjusted for baseline rectosigmoidoscopy score and stratification factors|An odds ratio \> 1.0 indicates a higher healing rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using healing rates from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||2.22|0.21|0.60
71027478|NCT01694485|141561607|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Healing Rates|-4.6|||||TWO_SIDED|90.0|-14.9|11.3||||||The difference in adjusted healing rates, estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||11.3|-14.9|
71027479|NCT01694485|141561608|SUPERIORITY||Odds Ratio (OR)|2.94||||0.09|TWO_SIDED|90.0|1.03|8.36|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||8.36|1.03|0.090
71027480|NCT01694485|141561608|SUPERIORITY||Difference in Adjusted Remission Rates|5.8|||||TWO_SIDED|90.0|-0.6|10.4||||||The difference in adjusted sustained remission rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||10.4|-0.6|
71027481|NCT01694485|141561608|SUPERIORITY||Odds Ratio (OR)|1.32||||0.72|TWO_SIDED|90.0|0.38|4.56|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.56|0.38|0.72
71027482|NCT01694485|141561608|SUPERIORITY||Difference in Adjusted Remission Rates|1.0|||||TWO_SIDED|90.0|-4.7|4.6||||||The difference in adjusted sustained remission rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.6|-4.7|
71027483|NCT01694485|141561608|SUPERIORITY|Comparisons of abrilumab 21 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.83||||0.86|TWO_SIDED|90.0|0.16|4.41|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.41|0.16|0.86
71027484|NCT01694485|141561608|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Remission Rates|-0.5|||||TWO_SIDED|90.0|-3.9|6.2||||||The difference in adjusted sustained remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||6.2|-3.9|
71027485|NCT01694485|141561608|SUPERIORITY|Comparisons of abrilumab 7 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.49||||0.64|TWO_SIDED|90.0|0.04|6.31|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||6.31|0.04|0.64
71027486|NCT01694485|141561608|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Remission Rates|-1.7|||||TWO_SIDED|90.0|-4.2|6.4||||||The difference in adjusted sustained remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||6.4|-4.2|
71027487|NCT00662025|141561635|SUPERIORITY_OR_OTHER||Objective Response Rate (percentage)|30.2|||||TWO_SIDED|95.0|19.2|43.0||||||||43.0|19.2|
71027488|NCT00662025|141561636|SUPERIORITY_OR_OTHER||Objective Response Rate (percentage)|27.0|||||TWO_SIDED|95.0|16.6|39.7||||||||39.7|16.6|
71027489|NCT00662025|141561637|SUPERIORITY_OR_OTHER||CBR Rate (percentage)|50.8|||||TWO_SIDED|95.0|37.9|63.6||||||||63.6|37.9|
71027490|NCT00662025|141561638|SUPERIORITY_OR_OTHER||CBR Rate (percentage)|52.4|||||TWO_SIDED|95.0|39.4|65.1||||||||65.1|39.4|
71027491|NCT03179345|141561652|SUPERIORITY||Mean Difference (Net)|-0.141|STANDARD_ERROR_OF_MEAN|0.06||0.0275|TWO_SIDED|95.0|-0.266|-0.016|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within Sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||-0.016|-0.266|0.0275
71027492|NCT03179345|141561652|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.06||0.0611|TWO_SIDED|95.0|-0.006|0.245|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.245|-0.006|0.0611
71059726|NCT03288714|141626389|SUPERIORITY|||||||0.015||||||Alpha level: .05|ANCOVA|P-value is from analysis of covariance adjusting for baseline||||||.015
71059727|NCT03288714|141626390|SUPERIORITY|||||||0.028||||||Alpha level: .05|Fisher Exact|The proportion of patients is compared across treatment groups using Fisher's Exact.||||||.028
71059728|NCT04882241|141626391|OTHER||Hazard Ratio (HR)|0.92||||0.39528|TWO_SIDED|95.0|0.5|1.7||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.70|0.50|0.39528
71059729|NCT04882241|141626392|OTHER||Difference in Percentage|1.9||||0.33244|TWO_SIDED|95.0|-7.7|12.0|||Miettinen and Nurminen|Based on unstratified Miettinen \& Nurminen method||||12.0|-7.7|0.33244
71027493|NCT03179345|141561653|SUPERIORITY||Mean Difference (Net)|-0.102|STANDARD_ERROR_OF_MEAN|0.06||0.1103|TWO_SIDED|95.0|-0.227|0.024|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.024|-0.227|0.1103
71027494|NCT03179345|141561653|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.06||0.0611|TWO_SIDED|95.0|-0.006|0.245|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.245|-0.006|0.0611
71027495|NCT03179345|141561654|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.9946|TWO_SIDED|95.0|-0.02|0.02|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.02|-0.02|0.9946
71027496|NCT03179345|141561654|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.0125||0.1673|TWO_SIDED|95.0|-0.01|0.04|||ANCOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.04|-0.01|0.1673
71027497|NCT03179345|141561654|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.0125||0.6208|TWO_SIDED|95.0|-0.02|0.03|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.03|-0.02|0.6208
71027498|NCT03179345|141561655|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|2.6||0.8799|TWO_SIDED|95.0|-5.59|4.8|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||4.80|-5.59|0.8799
71027499|NCT03179345|141561655|SUPERIORITY||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|2.61||0.9277|TWO_SIDED|95.0|-4.97|5.45|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||5.45|-4.97|0.9277
71027500|NCT03179345|141561655|SUPERIORITY||Mean Difference (Net)|-3.73||||0.1587|TWO_SIDED|95.0|-8.94|1.49|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||1.49|-8.94|0.1587
71109530|NCT02722408|141724363|OTHER|||||||0.2057||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.2057
71109531|NCT02722408|141724363|OTHER|||||||0.2892||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.2892
71109532|NCT02722408|141724363|OTHER|||||||0.0052||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.0052
71109533|NCT02722408|141724363|OTHER|||||||0.0028||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.0028
71109534|NCT02722408|141724363|OTHER|||||||0.0026||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.0026
71109535|NCT02722408|141724363|OTHER|||||||0.0493||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0493
71109536|NCT02722408|141724363|OTHER|||||||0.0253||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0253
71109537|NCT02722408|141724363|OTHER|||||||0.0394||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0394
71027501|NCT03179345|141561656|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.0125||0.7111|TWO_SIDED|95.0|-0.03|0.02|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.02|-0.03|0.7111
71027502|NCT03179345|141561656|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.9048|TWO_SIDED|95.0|-0.02|0.02|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.02|-0.02|0.9048
71027503|NCT03179345|141561656|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.3262|TWO_SIDED|95.0|-0.03|0.01|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.01|-0.03|0.3262
71027504|NCT03179345|141561657|SUPERIORITY||Mean Difference (Net)|-0.46|STANDARD_ERROR_OF_MEAN|0.86||0.595|TWO_SIDED|95.0|-2.18|1.26|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||1.26|-2.18|0.5950
71027505|NCT03179345|141561657|SUPERIORITY||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.865||0.7057|TWO_SIDED|95.0|-1.4|2.06|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||2.06|-1.40|0.7057
71027506|NCT03179345|141561657|SUPERIORITY||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|0.865||0.6741|TWO_SIDED|95.0|-1.36|2.1|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||2.10|-1.36|0.6741
71027507|NCT03179345|141561658|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.0175||0.007|TWO_SIDED|95.0|-0.08|-0.01|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||-0.01|-0.08|0.0070
71059730|NCT04882241|141626393|OTHER||Hazard Ratio (HR)|1.03||||0.52903|TWO_SIDED|95.0|0.48|2.22||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||2.22|0.48|0.52903
71059731|NCT04882241|141626398|OTHER||Hazard Ratio (HR)|0.83||||0.34632|TWO_SIDED|95.0|0.34|2.05||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||2.05|0.34|0.34632
71059732|NCT02543944|141626409|SUPERIORITY||Risk Ratio (RR)|-0.0944|STANDARD_ERROR_OF_MEAN|0.32||0.77|TWO_SIDED|95.0|-0.72|0.53|||Regression, Logistic|||||0.53|-0.72|0.77
71059733|NCT02543944|141626410|SUPERIORITY||Odds Ratio (OR)|0.3||||0.58|TWO_SIDED||||||Chi-squared|||||||0.58
71059734|NCT02543944|141626411|SUPERIORITY||Odds Ratio (OR)|0.16||||0.69|TWO_SIDED||||||Chi-squared|||||||0.69
71059735|NCT02543944|141626412|SUPERIORITY||Odds Ratio (OR)|0.96||||0.32|TWO_SIDED||||||Chi-squared|||||||0.32
71059736|NCT02203357|141626413|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0||||The p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance.|ANOVA|||||||<0.05
71059737|NCT00629018|141626419|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Log Rank|||The minimal sample size for the study was calculated using a pre-specified power of 90% and P value of 0.05.||||0.01
71059738|NCT05262387|141626435|OTHER||Mean Difference (Final Values)|9.32||||0.0494|TWO_SIDED|90.0|1.52|17.1|||Mixed Models Analysis|||||17.1|1.52|0.0494
71059739|NCT05262387|141626435|OTHER||Mean Difference (Final Values)|14.1||||0.0028|TWO_SIDED|90.0|6.38|21.9|||Mixed Models Analysis|||||21.9|6.38|0.0028
71109538|NCT02722408|141724363|OTHER|||||||0.0003||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0003
71059740|NCT05262387|141626436|OTHER||Mean Difference (Final Values)|-44.5||||0.1998|TWO_SIDED|90.0|-102.0|12.8|||Mixed Models Analysis|||||12.8|-102|0.1998
71059741|NCT05262387|141626436|OTHER||Mean Difference (Final Values)|4.16||||0.9041|TWO_SIDED|90.0|-53.1|61.4|||Mixed Models Analysis|||||61.4|-53.1|0.9041
71059742|NCT02515331|141626439|SUPERIORITY||Mean Difference (Net)|-8.555|STANDARD_ERROR_OF_MEAN|2.9077||0.002|TWO_SIDED|95.0|-14.388|-2.722||1-sided p-value|Longitudinal repeated measures mixed eff|||||-2.722|-14.388|0.002
71059743|NCT02515331|141626439|SUPERIORITY||Mean Difference (Net)|-14.727|STANDARD_ERROR_OF_MEAN|3.0548|<|0.001|TWO_SIDED|95.0|-20.852|-8.602||1-sided p-value|Longitudinal repeated measures mixed eff|||||-8.602|-20.852|<0.001
71059744|NCT01339403|141626491|SUPERIORITY_OR_OTHER||Rate ratio|166.1|||<|0.001|TWO_SIDED|95.0|123.4|223.5|||Poisson Regression|||Kaposi's sarcoma: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||223.5|123.4|<0.001
71059745|NCT01339403|141626491|SUPERIORITY_OR_OTHER||Rate ratio|12.1|||<|0.001|TWO_SIDED|95.0|10.3|14.2|||Poisson Regression|||Invasive non-Hodgkin's lymphoma: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||14.2|10.3|<0.001
71027508|NCT03179345|141561658|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.0175||0.5183|TWO_SIDED|95.0|-0.02|0.05|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.05|-0.02|0.5183
71027509|NCT03179345|141561658|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.0175||0.5084|TWO_SIDED|95.0|-0.05|0.02|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.02|-0.05|0.5084
71027510|NCT03179345|141561659|SUPERIORITY||Mean Difference (Net)|0.51|STANDARD_ERROR_OF_MEAN|0.307||0.1026|TWO_SIDED|95.0|-0.104|1.124|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||1.124|-0.104|0.1026
71059746|NCT01339403|141626491|SUPERIORITY_OR_OTHER||Rate ratio|3.4||||0.059|TWO_SIDED|95.0|1.0|12.3|||Poisson Regression|||Invasive cervical cancer: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||12.3|1.0|0.059
71059747|NCT01339403|141626491|SUPERIORITY_OR_OTHER||Rate ratio|1.7|||<|0.001|TWO_SIDED|95.0|1.5|1.8|||Poisson Regression|||Non-AIDS-defining cancers: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||1.8|1.5|<0.001
71059748|NCT01339403|141626491|SUPERIORITY_OR_OTHER||Rate Ratio|166.1|||<|0.001|TWO_SIDED|95.0|123.4|223.5|||Poisson Regression|||AIDS-defining cancer: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||223.5|123.4|<0.001
71059749|NCT01339403|141626492|SUPERIORITY_OR_OTHER||Rate ratio|1.4|||<|0.001|TWO_SIDED|95.0|1.3|1.5|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||1.5|1.3|<0.001
71059750|NCT01339403|141626493|SUPERIORITY_OR_OTHER||Rate ratio|65.7|||<|0.001|TWO_SIDED|95.0|57.1|75.7|||Poisson Regression|||Wasting syndrome: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||75.7|57.1|<0.001
71027511|NCT03179345|141561659|SUPERIORITY||Mean Difference (Net)|-0.094|STANDARD_ERROR_OF_MEAN|0.309||0.7634|TWO_SIDED|95.0|-0.711|0.523|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.523|-0.711|0.7634
71027512|NCT03179345|141561659|SUPERIORITY||Mean Difference (Net)|0.51|STANDARD_ERROR_OF_MEAN|0.309||0.1041|TWO_SIDED|95.0|-0.107|1.127|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||1.127|-0.107|0.1041
71027513|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.286|STANDARD_ERROR_OF_MEAN|0.12||0.0177|TWO_SIDED|95.0|-0.521|-0.051|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Vision||-0.051|-0.521|0.0177
71027514|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.157|STANDARD_ERROR_OF_MEAN|0.19||0.412|TWO_SIDED|95.0|-0.536|0.222|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Energy Level||0.222|-0.536|0.4120
71059751|NCT01339403|141626493|SUPERIORITY_OR_OTHER||Rate ratio|428.5|||<|0.001|TWO_SIDED|95.0|292.2|628.5|||Poisson Regression|||Pneumocystis jirovecii pneumonia: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||628.5|292.2|<0.001
71027515|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.046|STANDARD_ERROR_OF_MEAN|0.16||0.7724|TWO_SIDED|95.0|-0.362|0.27|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Memory||0.270|-0.362|0.7724
71059752|NCT01339403|141626493|SUPERIORITY_OR_OTHER||Rate ratio|8.7|||<|0.001|TWO_SIDED|95.0|7.9|9.5|||Poisson Regression|||Pneumonia, recurrent: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||9.5|7.9|<0.001
71059753|NCT01339403|141626493|SUPERIORITY_OR_OTHER||Rate ratio|97.1|||<|0.001|TWO_SIDED|95.0|75.5|124.8|||Poisson Regression|||Cytomegalovirus: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||124.8|75.5|<0.001
71027516|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.121|STANDARD_ERROR_OF_MEAN|0.15||0.4255|TWO_SIDED|95.0|-0.423|0.18|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Walking Balance||0.180|-0.423|0.4255
71027517|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|0.017|STANDARD_ERROR_OF_MEAN|0.12||0.8925|TWO_SIDED|95.0|-0.229|0.262|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Interest in activities||0.262|-0.229|0.8925
71027518|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.212|STANDARD_ERROR_OF_MEAN|0.14||0.1293|TWO_SIDED|95.0|-0.487|0.063|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Coordination||0.063|-0.487|0.1293
71027519|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.06||0.0304|TWO_SIDED|95.0|-0.266|-0.014|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Tremor||-0.014|-0.266|0.0304
71027520|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.084|STANDARD_ERROR_OF_MEAN|0.15||0.5811|TWO_SIDED|95.0|-0.384|0.217|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Concentration||0.217|-0.384|0.5811
71027521|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.098|STANDARD_ERROR_OF_MEAN|0.06||0.1144|TWO_SIDED|95.0|-0.22|0.024|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Speech||0.024|-0.220|0.1144
71059754|NCT01339403|141626493|SUPERIORITY_OR_OTHER||Rate ratio|60.2|||<|0.001|TWO_SIDED|95.0|48.3|74.9|||Poisson Regression|||Esophageal Candidiasis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||74.9|48.3|<0.001
71059755|NCT01339403|141626493|SUPERIORITY_OR_OTHER||Rate ratio|98.4|||<|0.001|TWO_SIDED|95.0|70.8|136.8|||Poisson Regression|||Mycobacterium avium complex: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||136.8|70.8|<0.001
71059756|NCT01339403|141626493|SUPERIORITY_OR_OTHER||Rate ratio|189.5|||<|0.001|TWO_SIDED|95.0|112.3|319.5|||Poisson Regression|||Cryptococcosis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||319.5|112.3|<0.001
71059757|NCT01339403|141626493|SUPERIORITY_OR_OTHER||Rate ratio|6.2|||<|0.001|TWO_SIDED|95.0|5.2|7.4|||Poisson Regression|||Mycobacterium tuberculosis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||7.4|5.2|<0.001
71059758|NCT01339403|141626493|SUPERIORITY_OR_OTHER||Rate ratio|594.5|||<|0.001|TWO_SIDED|95.0|146.5|2411.7|||Poisson Regression|||Progressive multifocal leukoencephalopathy: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||2411.7|146.5|<0.001
71059759|NCT01339403|141626493|SUPERIORITY_OR_OTHER||Rate ratio|10.6|||<|0.001|TWO_SIDED|95.0|7.8|14.4|||Poisson Regression|||Lung Candidiasis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||14.4|7.8|<0.001
71059760|NCT01339403|141626493|SUPERIORITY_OR_OTHER||Rate ratio|51.5|||<|0.001|TWO_SIDED|95.0|30.3|87.5|||Poisson Regression|||Toxoplasmosis of brain: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||87.5|30.3|<0.001
71059761|NCT01339403|141626493|SUPERIORITY_OR_OTHER||Rate ratio|6.2|||<|0.001|TWO_SIDED|95.0|3.0|12.9|||Poisson Regression|||Coccidiomycosis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||12.9|3.0|<0.001
71059762|NCT01339403|141626493|SUPERIORITY_OR_OTHER||Rate ratio|13.0|||<|0.0001|TWO_SIDED|95.0|7.4|23.1|||Poisson Regression|||Histoplasmosis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||23.1|7.4|<0.0001
71059763|NCT01339403|141626494|SUPERIORITY_OR_OTHER||Rate ratio|4.7|||<|0.001|TWO_SIDED|95.0|4.3|5.1|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||5.1|4.3|<0.001
71059764|NCT01339403|141626495|SUPERIORITY_OR_OTHER||Rate ratio|7.0|||<|0.001|TWO_SIDED|95.0|6.0|8.2|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||8.2|6.0|<0.001
71059765|NCT01339403|141626496|SUPERIORITY_OR_OTHER||Rate ratio|8.3|||<|0.001|TWO_SIDED|95.0|7.1|9.6|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||9.6|7.1|<0.001
71059766|NCT01339403|141626497|SUPERIORITY_OR_OTHER||Rate ratio|5.6|||<|0.001|TWO_SIDED|95.0|5.3|5.9|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||5.9|5.3|<0.001
71059767|NCT01339403|141626498|SUPERIORITY_OR_OTHER||Rate ratio|19.8|||<|0.001|TWO_SIDED|95.0|11.2|35.2|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||35.2|11.2|<0.001
71059768|NCT03983980|141626499|SUPERIORITY||Risk Ratio (RR)|6.1|||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
71059769|NCT03983980|141626500|SUPERIORITY||Risk Ratio (RR)|6.53|||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
71109539|NCT02722408|141724363|OTHER|||||||0.0002||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0002
71059770|NCT03983980|141626501|SUPERIORITY||Risk Ratio (RR)|4.55|||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
71059771|NCT03983980|141626502|SUPERIORITY||Least squares mean difference|-4.32|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71059772|NCT03983980|141626503|SUPERIORITY||Risk Ratio (RR)|7.25|||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
71059773|NCT01349192|141626557|SUPERIORITY||Proportion Difference (Final Values)|0.56||||0.0005|TWO_SIDED|95.0|0.25|0.74||The a priori threshold for statistical significance was 0.05.|Chi-squared||Proportion difference was calculated as proportion negative for MRSA in the treatment group minus the proportion negative for MRSA in the observation group. 95% CI calculated using the Newcombe-Wilson method without continuity correction.|||0.74|0.25|0.0005
70935866|NCT02334215|141372802|SUPERIORITY|||||||0.32|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation and Methadone arms compared to Enhanced Treatment as Usual||||.32
70935867|NCT02334215|141372802|SUPERIORITY|||||||0.32|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||.32
70935868|NCT02334215|141372803|SUPERIORITY|||||||0.001|||||||Generalized Linear Mixed Model Analysis|||Contrast of Interest: Methadone plus Patient Navigation and Methadone Conditions combined vs. Enhanced Treatment as Usual Conditions||||.001
70935869|NCT02334215|141372803|SUPERIORITY|||||||0.84|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Enhanced Treatment as Usual||||.84
71027522|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.109|STANDARD_ERROR_OF_MEAN|0.12||0.3774|TWO_SIDED|95.0|-0.352|0.135|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Forgetfulness||0.135|-0.352|0.3774
71027523|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|0.057|STANDARD_ERROR_OF_MEAN|0.34||0.8658|TWO_SIDED|95.0|-0.613|0.727|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Sleepiness||0.727|-0.613|0.8658
70935870|NCT02334215|141372804|SUPERIORITY|||||||0.11|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation and Methadone Conditions combined vs. Enhanced Treatment as Usual||||0.11
70935871|NCT02334215|141372804|SUPERIORITY|||||||0.55|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||0.55
70935872|NCT02334215|141372805|SUPERIORITY|||||||0.55|||||||Regression, Logistic|||||||0.55
70935873|NCT02334215|141372805|SUPERIORITY|||||||0.57|||||||Regression, Logistic|||Contrast of interest: Methadone plus Patient Navigation vs Methadone||||0.57
70935874|NCT02334215|141372806|SUPERIORITY|||||||0.997|||||||Generalized Linear Mixed Model|||Contrast of interest: Methadone plus Patient Navigation and Methadone compared to Enhanced Treatment as Usual||||.997
70935875|NCT02334215|141372806|SUPERIORITY|||||||0.26|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs Methadone||||0.26
70935876|NCT02334215|141372807|SUPERIORITY|Contrast of interest: Methadone plus Patient Navigation and Methadone compared to Enhanced Treatment as Usual||||||0.663|||||||Generalized Linear Mixed Model|||||||.663
70935877|NCT02334215|141372807|SUPERIORITY|||||||0.33|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs Methadone||||0.33
70935878|NCT02334215|141372808|SUPERIORITY|||||||0.007|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation and Methadone arms compared to Enhanced Treatment as Usual||||0.007
70935879|NCT02334215|141372808|SUPERIORITY|||||||0.76|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||.76
70935880|NCT02334215|141372809|SUPERIORITY|||||||0.6|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Enhanced Treatment as Usual||||0.60
70935881|NCT02334215|141372809|SUPERIORITY|||||||1|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||1.0
70935882|NCT02334215|141372810|SUPERIORITY|||||||0.09|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||.09
70935883|NCT02334215|141372810|SUPERIORITY|||||||0.74|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||.74
70935884|NCT02334215|141372811|SUPERIORITY|||||||0.013|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||.013
71027524|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|0.018|STANDARD_ERROR_OF_MEAN|0.1||0.8543|TWO_SIDED|95.0|-0.179|0.216|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Moodiness||0.216|-0.179|0.8543
71027525|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.153|STANDARD_ERROR_OF_MEAN|0.19||0.4294|TWO_SIDED|95.0|-0.537|0.231|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Alertness||0.231|-0.537|0.4294
71027526|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.113|STANDARD_ERROR_OF_MEAN|0.12||0.3613|TWO_SIDED|95.0|-0.357|0.132|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Attention Span||0.132|-0.357|0.3613
71027527|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.047|STANDARD_ERROR_OF_MEAN|0.13||0.7201|TWO_SIDED|95.0|-0.305|0.212|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Motivation||0.212|-0.305|0.7201
70935885|NCT02334215|141372811|SUPERIORITY|||||||0.71|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||.71
71027528|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.213|STANDARD_ERROR_OF_MEAN|0.12||0.0767|TWO_SIDED|95.0|-0.448|0.023|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Vision||0.023|-0.448|0.0767
71027529|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.216|STANDARD_ERROR_OF_MEAN|0.19||0.2618|TWO_SIDED|95.0|-0.597|0.165|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Energy Level||0.165|-0.597|0.2618
71027530|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.048|STANDARD_ERROR_OF_MEAN|0.16||0.7633|TWO_SIDED|95.0|-0.366|0.269|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Memory||0.269|-0.366|0.7633
71027531|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.198|STANDARD_ERROR_OF_MEAN|0.15||0.1968|TWO_SIDED|95.0|-0.502|0.105|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Walking Balance||0.105|-0.502|0.1968
71109540|NCT02722408|141724363|OTHER|||||||0.0002||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0002
70935886|NCT02334215|141372812|SUPERIORITY|Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||||0.32|||||||Generalized Linear Mixed Model Analysis|||||||.32
71059774|NCT01349192|141626557|SUPERIORITY||Proportion Difference (Final Values)|0.525||||0.0004|TWO_SIDED|95.0|0.23|0.8||Test includes adjustment for two interim reviews of efficacy data. The a priori threshold for statistical significance was 0.05.|Chi-squared||Proportion difference was calculated as proportion negative for MRSA in the treatment group minus the proportion negative for MRSA in the observation group.|||0.80|0.23|0.0004
71059775|NCT01349192|141626558|SUPERIORITY||Proportion Difference (Final Values)|0.09||||0.5463|TWO_SIDED|95.0|-0.18|0.34||The a priori threshold for statistical significance was 0.05.|Chi-squared||Proportion difference was calculated as proportion using antibiotics in the treatment group minus the proportion using antibiotics in the observation group. 95% CI calculated using the Newcombe-Wilson method without continuity correction.|||0.34|-0.18|0.5463
71059776|NCT01349192|141626559|SUPERIORITY||Mean Difference (Final Values)|-9.42||||0.3683|TWO_SIDED|95.0|-30.3|11.47||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided||Mean difference was calculated as mean days of antibiotic use in the treatment group minus the mean days of antibiotic use in the observation group.|||11.47|-30.3|0.3683
71059777|NCT01349192|141626560|SUPERIORITY||Proportion Difference (Final Values)|-0.2||||0.1205|TWO_SIDED|95.0|-0.42|0.03||The a priori threshold for statistical significance was 0.05.|Chi-squared||Difference was calculated as proportion with a PE treated with MRSA active antibiotics in the treatment group minus the analogous proportion in the observation group. 95% CI calculated using the Newcombe-Wilson method without continuity correction.|||0.03|-0.42|0.1205
71059778|NCT03749330|141626573|EQUIVALENCE|test of difference between pre and post|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71109541|NCT02722408|141724364|OTHER|||||||0.3833||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.3833
70935887|NCT02334215|141372812|SUPERIORITY|||||||0.85|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||0.85
71027532|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.12||0.6891|TWO_SIDED|95.0|-0.296|0.197|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Interest in Activities||0.197|-0.296|0.6891
71027533|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.171|STANDARD_ERROR_OF_MEAN|0.14||0.2229|TWO_SIDED|95.0|-0.447|0.106|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Coordination||0.106|-0.447|0.2229
71027534|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.072|STANDARD_ERROR_OF_MEAN|0.06||0.2591|TWO_SIDED|95.0|-0.197|0.054|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Tremor||0.054|-0.197|0.2591
71027535|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.057|STANDARD_ERROR_OF_MEAN|0.15||0.7099|TWO_SIDED|95.0|-0.359|0.246|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Concentration||0.246|-0.359|0.7099
71027536|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.031|STANDARD_ERROR_OF_MEAN|0.06||0.6215|TWO_SIDED|95.0|-0.154|0.092|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Speech||0.092|-0.154|0.6215
71027537|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.057|STANDARD_ERROR_OF_MEAN|0.12||0.6422|TWO_SIDED|95.0|-0.302|0.187|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Forgetfulness||0.187|-0.302|0.6422
71027538|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.483|STANDARD_ERROR_OF_MEAN|0.34||0.1574|TWO_SIDED|95.0|-1.157|0.19|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Sleepiness||0.190|-1.157|0.1574
71027539|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|0.084|STANDARD_ERROR_OF_MEAN|0.1||0.4039|TWO_SIDED|95.0|-0.115|0.282|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Moodiness||0.282|-0.115|0.4039
71027540|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.309|STANDARD_ERROR_OF_MEAN|0.19||0.1145|TWO_SIDED|95.0|-0.695|0.076|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Alertness||0.076|-0.695|0.1145
71027541|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.127|STANDARD_ERROR_OF_MEAN|0.12||0.3083|TWO_SIDED|95.0|-0.372|0.119|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Attention Span||0.119|-0.372|0.3083
70935888|NCT02334215|141372813|SUPERIORITY|Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||||0.1|||||||Generalized Linear Mixed Model Analysis|||||||.10
70935889|NCT02334215|141372813|SUPERIORITY|||||||0.74|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||.74
70935890|NCT02334215|141372814|SUPERIORITY|Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||||0.42|||||||Generalized Linear Mixed Model Analysis|||||||.42
70935891|NCT02334215|141372814|SUPERIORITY|||||||0.42|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||0.42
70935892|NCT02334215|141372815|SUPERIORITY|Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||||0.28|||||||Generalized Linear Mixed Model Analysis|||||||.28
70935893|NCT02334215|141372815|SUPERIORITY|||||||0.44|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||0.44
70935894|NCT02334215|141372816|SUPERIORITY|||||||0.61|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation and Methadone combined vs. Enhanced Treatment as Usual||||.61
71027542|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.183|STANDARD_ERROR_OF_MEAN|0.13||0.1638|TWO_SIDED|95.0|-0.443|0.0776|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Motivation||0.0776|-0.443|0.1638
71027543|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.078|STANDARD_ERROR_OF_MEAN|0.12||0.5101|TWO_SIDED|95.0|-0.314|0.157|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Vision||0.157|-0.314|0.5101
71027544|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.233|STANDARD_ERROR_OF_MEAN|0.19||0.2285|TWO_SIDED|95.0|-0.614|0.149|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Energy Level||0.149|-0.614|0.2285
71027545|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|0.118|STANDARD_ERROR_OF_MEAN|0.16||0.4612|TWO_SIDED|95.0|-0.2|0.436|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Memory||0.436|-0.200|0.4612
71027546|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|0.099|STANDARD_ERROR_OF_MEAN|0.15||0.519|TWO_SIDED|95.0|-0.205|0.402|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Walking Balance||0.402|-0.205|0.5190
70935895|NCT02334215|141372816|SUPERIORITY|||||||0.72|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||0.72
70935896|NCT02334215|141372817|SUPERIORITY|Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||||0.71|||||||Generalized Linear Mixed Model Analysis|||||||.71
70935897|NCT02334215|141372817|SUPERIORITY|||||||0.86|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||.86
71059779|NCT00114140|141626646|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Z-test|||Assuming exponential distribution of survival times, the null hypothesis was a 43% increase in median survival time (40.5 mo. to 57.9 mo.) and a 21% increase in 3-year survival rate (54% to 65%). Assuming 5% ineligibility, 72 patients were required to be accrued over 3 years with 3-years of follow-up resulting in 80% power and 1-sided 0.10 significance level. (N later increased to 135 to accommodate an additional separate analysis of O-6-Methylguanine-DNA Methyltransferase (MGMT) status.)||||<0.001
71059780|NCT00114140|141626648|SUPERIORITY||Hazard Ratio (HR)|3.52||||0.0006|TWO_SIDED|95.0|1.64|7.56||Two-sided significance level of 0.05|Log Rank||Reference level = Methylated|Overall survival: The sample size was increased to 135 to ensure adequate power to detect a hazard ratio (HR) of 2.5 for MGMT status, at a 2-sided significance level of 0.05 with an MGMT prevalence rate of at least 30%||7.56|1.64|0.0006
71059781|NCT00114140|141626648|SUPERIORITY||Hazard Ratio (HR)|3.06||||0.0007|TWO_SIDED|95.0|1.55|6.04||Two-sided significance level of 0.05|Log Rank||Reference level = Methylated|Progression-free survival||6.04|1.55|0.0007
71059782|NCT00129545|141626686|NON_INFERIORITY_OR_EQUIVALENCE|The posterior probability of non-inferiority is defined as the probability that the event rate for the Device group is less than twice that for the Control group. This probability was required to be greater than 0.975 for a finding of non-inferiority. The criterion for non-inferiority was consistently met at each analysis time point demonstrating the Device group is non-inferior to the Control group.|Risk Ratio (RR)|0.61|||||TWO_SIDED|95.0|0.42|1.07|||||Relative Risk calculated as Device Rate over Control rate, with 95% Credible Intervals|||1.07|0.42|
71059783|NCT02969044|141626701|SUPERIORITY||Mean Difference (Net)|-9.25|||<|0.001|TWO_SIDED|95.0|-14.75|-3.79|||ANCOVA|||||-3.79|-14.75|<0.001
71059784|NCT00262028|141626722|NON_INFERIORITY_OR_EQUIVALENCE|MenACWY-CRM was considered to be noninferior to the licensed comparator if the lower limit (LL) of the 95% confidence intervals (CI) of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> -10% against each serogroup|Vaccine group difference|37.0|||||TWO_SIDED|95.0|29.0|44.0||||||Noninferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup A||44|29|
71059785|NCT00262028|141626722|NON_INFERIORITY_OR_EQUIVALENCE|MenACWY-CRM was considered to be noninferior to the licensed comparator if the lower LL of the 95% CI of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> -10% against each serogroup|Vaccine group difference|19.0|||||TWO_SIDED|95.0|12.0|26.0||||||Noninferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup C||26|12|
71059786|NCT00262028|141626722|NON_INFERIORITY_OR_EQUIVALENCE|MenACWY-CRM was considered to be noninferior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> -10% against each serogroup|Vaccine group difference|23.0|||||TWO_SIDED|95.0|17.0|29.0||||||Noninferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup W||29|17|
71059787|NCT00262028|141626722|NON_INFERIORITY_OR_EQUIVALENCE|MenACWY-CRM was considered to be noninferior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> -10% against each serogroup|Vaccine group difference|31.0|||||TWO_SIDED|95.0|25.0|38.0||||||No inferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup Y||38|25|
71059788|NCT00262028|141626722|SUPERIORITY_OR_OTHER||Vaccine group difference|37.0|||||TWO_SIDED|95.0|29.0|44.0||||||"Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup A~MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> 0% against each serogroup"||44|29|
71109542|NCT02722408|141724364|OTHER|||||||0.2172||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.2172
71109543|NCT02722408|141724364|OTHER|||||||0.293||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.2930
71109544|NCT02722408|141724364|OTHER|||||||0.1217||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.1217
70935898|NCT03976323|141372821|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.8721|TWO_SIDED|95.0|0.92|1.36||One-sided p-value based on log-rank test stratified by Eastern Cooperative Oncology Group (ECOG) at pre-randomization visit, response at randomization and baseline PD-L1 status.|Log Rank||Based on Cox regression model with Efron's method of tie handling and with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.|||1.36|0.92|0.8721
70935899|NCT03976323|141372822|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.6649|TWO_SIDED|95.0|0.87|1.25||One-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.|Log Rank||Based on Cox regression model with Efron's method of tie handling and with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.|||1.25|0.87|0.6649
70935900|NCT03976323|141372825|SUPERIORITY||Difference in Least Squares (LS) Means|-1.9||||0.2533|TWO_SIDED|95.0|-5.16|1.36||Two-sided p-value based on t test.|t-test, 2 sided||Based on constrained longitudinal data analysis model (cLDA) model with PRO scores as response variable with covariates for treatment by time interaction, stratification factors, response at randomization and baseline PD-L1 expression as covariates.|||1.36|-5.16|0.2533
71027547|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.024|STANDARD_ERROR_OF_MEAN|0.12||0.8479|TWO_SIDED|95.0|-0.271|0.223|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Interest in Activities||0.223|-0.271|0.8479
71027548|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.039|STANDARD_ERROR_OF_MEAN|0.14||0.7808|TWO_SIDED|95.0|-0.316|0.238|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Coordination||0.238|-0.316|0.7808
71027549|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.171|STANDARD_ERROR_OF_MEAN|0.06||0.0083|TWO_SIDED|95.0|-0.296|-0.045|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Tremor||-0.045|-0.296|0.0083
71027550|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.101|STANDARD_ERROR_OF_MEAN|0.15||0.5068|TWO_SIDED|95.0|-0.404|0.201|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Concentration||0.201|-0.404|0.5068
71027551|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.068|STANDARD_ERROR_OF_MEAN|0.06||0.2725|TWO_SIDED|95.0|-0.191|0.055|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Speech||0.055|-0.191|0.2725
71027552|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|0.039|STANDARD_ERROR_OF_MEAN|0.12||0.7498|TWO_SIDED|95.0|-0.206|0.284|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Forgetfulness||0.284|-0.206|0.7498
71027553|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|0.152|STANDARD_ERROR_OF_MEAN|0.34||0.6554|TWO_SIDED|95.0|-0.522|0.826|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Sleepiness||0.826|-0.522|0.6554
71027554|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|0.082|STANDARD_ERROR_OF_MEAN|0.1||0.4143|TWO_SIDED|95.0|-0.116|0.28|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Moodiness||0.280|-0.116|0.4143
71027555|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.055|STANDARD_ERROR_OF_MEAN|0.19||0.7761|TWO_SIDED|95.0|-0.441|0.33|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Alertness||0.330|-0.441|0.7761
71059789|NCT00262028|141626722|SUPERIORITY_OR_OTHER||Vaccine group difference|19.0|||||TWO_SIDED|95.0|12.0|26.0||||||"Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup C~MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> 0% against each serogroup"||26|12|
71027556|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|0.005|STANDARD_ERROR_OF_MEAN|0.12||0.9697|TWO_SIDED|95.0|-0.241|0.251|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Attention Span||0.251|-0.241|0.9697
71027557|NCT03179345|141561660|SUPERIORITY||Mean Difference (Net)|-0.086|STANDARD_ERROR_OF_MEAN|0.13||0.5118|TWO_SIDED|95.0|-0.346|0.174|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.||Motivation|SE of difference estimated by dividing width of 95% CI by 4.|0.174|-0.346|0.5118
71027558|NCT03179345|141561661|SUPERIORITY||Mean Difference (Net)|-0.116|STANDARD_ERROR_OF_MEAN|0.53||0.8293|TWO_SIDED|95.0|-1.178|0.947|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.947|-1.178|0.8293
71027559|NCT03179345|141561661|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.53||0.9705|TWO_SIDED|95.0|-1.089|1.049|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||1.049|-1.089|0.9705
71027560|NCT03179345|141561662|SUPERIORITY||Mean Difference (Net)|-0.488|STANDARD_ERROR_OF_MEAN|0.53||0.3666|TWO_SIDED|95.0|-1.556|0.581|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.581|-1.556|0.3666
71027561|NCT03179345|141561662|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.53||0.9705|TWO_SIDED|95.0|-1.089|1.049|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||1.049|-1.089|0.9705
71027562|NCT02300025|141561664|SUPERIORITY_OR_OTHER||LS means ratio|92.2|||||TWO_SIDED|90.0|59.2|143.4|||||The 90% CI for differences in LS means between test and reference treatments obtained from mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|Cmax was analyzed using a mixed model analysis of variance (ANOVA) to determine 90% confidence interval (CI) of the ratio between normal hepatic function (reference) and mild hepatic impairment (test) where hepatic impairment group was a fixed factor. The least squares (LS) means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||143.4|59.2|
71109545|NCT02722408|141724364|OTHER|||||||0.0901||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.0901
71109546|NCT02722408|141724364|OTHER|||||||0.085||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.0850
71109547|NCT02722408|141724364|OTHER|||||||0.0747||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0747
70941729|NCT04748445|141383935|OTHER||Slope|-0.0001528|STANDARD_ERROR_OF_MEAN|5.586||0.7849|TWO_SIDED|90.0|-0.001079|0.0007729|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0007729|-0.001079|0.7849
71027563|NCT02300025|141561664|SUPERIORITY_OR_OTHER||LS means ratio|84.9|||||TWO_SIDED|90.0|54.6|132.1|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|Cmax was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and moderate hepatic impairment (test) where hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||132.1|54.6|
71027564|NCT02300025|141561664|SUPERIORITY_OR_OTHER||LS means ratio|39.0|||||TWO_SIDED|90.0|25.1|60.7|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|Cmax was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and severe hepatic impairment (test) where hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||60.7|25.1|
71027565|NCT02300025|141561666|SUPERIORITY_OR_OTHER||LS means ratio|98.4|||||TWO_SIDED|90.0|52.0|186.0|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0-t) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and mild hepatic impairment (test) where, hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||186.0|52.0|
71027566|NCT02300025|141561666|SUPERIORITY_OR_OTHER||LS means ratio|102.2|||||TWO_SIDED|90.0|54.0|193.2|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0-t) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and moderate hepatic impairment (test) where, hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||193.2|54.0|
71109548|NCT02722408|141724364|OTHER|||||||0.0279||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.0279
71109549|NCT02722408|141724364|OTHER|||||||0.0492||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0492
71109550|NCT02722408|141724364|OTHER|||||||0.0003||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0003
71109551|NCT02722408|141724364|OTHER|||||||0.0002||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0002
71109552|NCT02722408|141724364|OTHER|||||||0.0002||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0002
71109553|NCT02722408|141724365|OTHER|||||||0.8972||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.8972
71109554|NCT02722408|141724365|OTHER|||||||0.7867||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.7867
71109555|NCT02722408|141724365|OTHER|||||||0.4974||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.4974
71109556|NCT02722408|141724365|OTHER|||||||0.5464||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.5464
71027567|NCT02300025|141561666|SUPERIORITY_OR_OTHER||LS means ratio|42.5|||||TWO_SIDED|90.0|22.5|80.5|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0-t) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and severe hepatic impairment (test) where, hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||80.5|22.5|
71027568|NCT02300025|141561667|SUPERIORITY_OR_OTHER||LS means ratio|97.6|||||TWO_SIDED|90.0|59.3|160.6|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0 - ∞) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and mild hepatic impairment (test) where hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||160.6|59.3|
71027569|NCT02300025|141561667|SUPERIORITY_OR_OTHER||LS means ratio|103.0|||||TWO_SIDED|90.0|62.6|169.6|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0 - ∞) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and moderate hepatic impairment (test) where hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||169.6|62.6|
70935901|NCT03976323|141372826|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8125|TWO_SIDED|95.0|0.76|1.24||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.24|0.76|0.8125
71027570|NCT02300025|141561667|SUPERIORITY_OR_OTHER||LS means ratio|68.5|||||TWO_SIDED|90.0|40.4|116.2|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0 - ∞) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and severe hepatic impairment (test) where hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||116.2|40.4|
71027571|NCT00626925|141561673|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||||||0.001
71027572|NCT00626925|141561674|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mixed Models Analysis|||||||0.01
71027573|NCT00626925|141561676|SUPERIORITY_OR_OTHER|||||||0.004|||||||Mixed Models Analysis|||||||0.004
71027574|NCT00626925|141561677|SUPERIORITY_OR_OTHER|||||||0.04|||||||Mixed Models Analysis|||||||0.04
71027575|NCT00626925|141561678|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||||||0.001
71027576|NCT00626925|141561679|SUPERIORITY_OR_OTHER|||||||0.06|||||||Mixed Models Analysis|||||||0.06
71027577|NCT00626925|141561680|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mixed Models Analysis|||||||0.01
71027578|NCT00780026|141561681|SUPERIORITY_OR_OTHER|||||||0.841||||||P value for Bacterial infection|Chi-squared|||||||0.841
71027579|NCT00780026|141561681|SUPERIORITY_OR_OTHER|||||||0.298||||||P-value for fungal infection|Chi-squared|||||||0.298
71027580|NCT00780026|141561681|SUPERIORITY_OR_OTHER|||||||0.585||||||P value for transplant incision wound|Chi-squared|||||||0.585
71027581|NCT00780026|141561681|SUPERIORITY_OR_OTHER|||||||0.505||||||P value for viral infection|Chi-squared|||||||0.505
71027582|NCT00780026|141561682|SUPERIORITY_OR_OTHER|||||||0.999|||||||Fisher Exact|||||||0.999
71027583|NCT00780026|141561683|EQUIVALENCE|If the p-value for the means is \> 0.05 between the groups then they will be deemed equivalent.||||||0.384|||||||Wilcoxon (Mann-Whitney)|||||||0.384
71027584|NCT00780026|141561685|SUPERIORITY_OR_OTHER|||||||0.401|||||||Fisher Exact|||||||0.401
71027585|NCT00780026|141561686|SUPERIORITY_OR_OTHER|||||||0.826||||||P value for bile leak|Chi-squared|||||||0.826
71027586|NCT00780026|141561686|SUPERIORITY_OR_OTHER|||||||0.137||||||This is the p value for Biliary Stricture|Chi-squared|||||||0.137
71027587|NCT00780026|141561687|SUPERIORITY_OR_OTHER|||||||0.999|||||||Fisher Exact|||||||0.999
71027588|NCT01966042|141561719|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Friedman test (n=13)|||||||< 0.001
71027589|NCT03522948|141561724|SUPERIORITY||Mean Difference (Net)|-3.16|STANDARD_DEVIATION|-0.71||0.03|TWO_SIDED||||||t-test, 2 sided|||within-subject t-test||||.03
71027590|NCT03522948|141561725|SUPERIORITY||t-test|-1.34|STANDARD_DEVIATION|3.2||0.23|TWO_SIDED||||||t-test, 2 sided||||d = -0.51|||0.23
71027591|NCT03522948|141561726|SUPERIORITY||t-test|1.35|||<|0.05|TWO_SIDED|95.0|-0.69|2.41|||t-test, 2 sided|||GSAB self-efficacy||2.41|-0.69|<.05
71027592|NCT03522948|141561727|SUPERIORITY||t-test|2.93|||<|0.05|TWO_SIDED|95.0|0.31|3.41|||t-test, 2 sided|||Test of GSAB self-efficacy subscale for condom use||3.41|0.31|<.05
71027593|NCT01047345|141561741|SUPERIORITY_OR_OTHER||Difference in Percentages|3.5||||0.026|TWO_SIDED|95.0|0.5|6.2|||Miettinen & Nurminen|||||6.2|0.5|0.026
71027594|NCT01047345|141561742|SUPERIORITY_OR_OTHER||Difference in Percentages|4.0|||||TWO_SIDED|95.0|-2.8|10.8|||Miettinen & Nurminen|||||10.8|-2.8|
71027595|NCT01047345|141561743|SUPERIORITY_OR_OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-1.5|0.9|||Miettinen & Nurminen|||||0.9|-1.5|
71027596|NCT01047345|141561744|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.2|||||TWO_SIDED|95.0|-1.7|0.6|||Miettinen & Nurminen|||||0.6|-1.7|
71027597|NCT01047345|141561745|SUPERIORITY_OR_OTHER||Difference in Percentages|10.2|||||TWO_SIDED|95.0|7.5|13.1|||Miettinen & Nurminen|||||13.1|7.5|
71027598|NCT01047345|141561746|SUPERIORITY_OR_OTHER||Seroconversion rate|99.8|||<|0.001|TWO_SIDED|95.0|98.9|100.0||statistical criterion of acceptability required that the lower bound of the 95% confidence interval (CI) for the proportion of participants seroconverting be greater than 90%|Clopper-Pearson|||Anti-HPV 31||100.0|98.9|<0.001
70935902|NCT03976323|141372827|SUPERIORITY||Difference in LS Means|-0.16||||0.9364|TWO_SIDED|95.0|-4.02|3.71||Two-sided p-value based on t test.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||3.71|-4.02|0.9364
70935903|NCT03976323|141372828|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.3782|TWO_SIDED|95.0|0.66|1.17||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.17|0.66|0.3782
70935904|NCT03976323|141372829|SUPERIORITY||Difference in LS Means|-0.35||||0.8285|TWO_SIDED|95.0|-3.54|2.83||Two-sided p-value based on t test.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||2.83|-3.54|0.8285
71027599|NCT01047345|141561746|SUPERIORITY_OR_OTHER||Seroconversion Rate|99.8|||<|0.001|TWO_SIDED|95.0|98.9|100.0||statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%|Clopper-Pearson|||Anti-HPV 33||100.0|98.9|<0.001
71027600|NCT01047345|141561746|SUPERIORITY_OR_OTHER||Seroconversion Rate|98.3|||<|0.001|TWO_SIDED|95.0|96.7|99.2||statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%|Clopper-Pearson|||Anti-HPV 45||99.2|96.7|<0.001
71027601|NCT01047345|141561746|SUPERIORITY_OR_OTHER||Seroconversion Rate|99.6|||<|0.001|TWO_SIDED|95.0|98.6|100.0||statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%|Clopper-Pearson|||Anti-HPV 52||100.0|98.6|<0.001
71059790|NCT00262028|141626722|SUPERIORITY_OR_OTHER||Vaccine group difference|23.0|||||TWO_SIDED|95.0|17.0|29.0||||||"Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup W~MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> 0% against each serogroup"||29|17|
71059791|NCT00262028|141626722|SUPERIORITY_OR_OTHER||Vaccine group difference|31.0|||||TWO_SIDED|95.0|25.0|38.0||||||"Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup Y~MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> 0% against each serogroup"||38|25|
71059792|NCT00143390|141626744|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of exemestane to anastrozole was to be concluded if the upper bound of the 95% confidence interval on the hazard ratio (exemestane/anastrozole) was ≤1.25.|Hazard Ratio (HR)|1.007|||||TWO_SIDED|95.0|0.771|1.317|||||Disease sites, use of postoperative adjuvant antiestrogen agents therapy, and pamidronate disodium were covariates for adjustment.|95% Confidence Interval based on the Brookmeyer and Crowley method||1.317|0.771|
71059793|NCT00143390|141626745|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of exemestane to anastrozole was to be concluded if the upper bound of the 95% confidence interval on the hazard ratio (exemestane/anastrozole) was ≤1.25.|Hazard Ratio (HR)|1.059|||||TWO_SIDED|95.0|0.816|1.374|||||Disease sites, use of postoperative adjuvant antiestrogen agents therapy, and pamidronate disodium were covariates for adjustment.|95% Confidence Interval based on the Brookmeyer and Crowley method||1.374|0.816|
71059794|NCT03417687|141626750|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-14.7%, +14.7%).|Mean Difference (Net)|1.4|STANDARD_DEVIATION|5.9|||TWO_SIDED|95.0|-0.75|3.6||||||The primary efficacy analysis tested the mean difference in the predicted percentage of remaining pulmonary function as measured by 129Xe MRI relative to the value as measured by 133Xe scintigraphy (reference standard) if a pre-defined section of lung were resected.||3.60|-0.75|
70935905|NCT03976323|141372830|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.6272|TWO_SIDED|95.0|0.78|1.51||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.51|0.78|0.6272
70935906|NCT03976323|141372831|SUPERIORITY||Difference in LS Means|-1.51||||0.4422|TWO_SIDED|95.0|-5.38|2.35||Two-sided p-value based on t test.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||2.35|-5.38|0.4422
71027602|NCT01047345|141561746|SUPERIORITY_OR_OTHER||Seroconversion Rate|99.8|||<|0.001|TWO_SIDED|95.0|98.9|100.0||statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%|Clopper-Pearson|||Anti-HPV 58||100.0|98.9|<0.001
71027603|NCT01984242|141561773|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9819|TWO_SIDED|95.0|0.69|1.45|||Log Rank|||||1.45|0.69|0.9819
71027604|NCT01984242|141561773|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.358|TWO_SIDED|95.0|0.82|1.71|||Log Rank|||||1.71|0.82|0.3580
71027605|NCT01984242|141561775|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.0952||95.0|0.38|1.08|||Log Rank|||||1.08|0.38|0.0952
71027606|NCT01984242|141561775|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.9172|TWO_SIDED|95.0|0.63|1.67|||Log Rank|||||1.67|0.63|0.9172
71109557|NCT02722408|141724365|OTHER|||||||0.7668||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.7668
71109558|NCT02722408|141724365|OTHER|||||||0.9276||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.9276
71027607|NCT01984242|141561777|SUPERIORITY||Hazard Ratio (HR)|0.48||||0.0153|TWO_SIDED|95.0|0.26|0.87|||Log Rank|||||0.87|0.26|0.0153
71027608|NCT01984242|141561777|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.5545|TWO_SIDED|95.0|0.48|1.46|||Log Rank|||||1.46|0.48|0.5545
71027609|NCT01984242|141561779|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.0086|TWO_SIDED|95.0|0.28|0.84|||Log Rank|||||0.84|0.28|0.0086
71027610|NCT01984242|141561779|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.7675||95.0|0.56|1.53|||Log Rank|||||1.53|0.56|0.7675
71027611|NCT01984242|141561781|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.1973||95.0|0.44|1.18|||Log Rank|||||1.18|0.44|0.1973
71027612|NCT01984242|141561781|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.7738|TWO_SIDED|95.0|0.65|1.76|||Log Rank|||||1.76|0.65|0.7738
71027613|NCT01984242|141561783|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.083||95.0|0.43|1.06|||Log Rank|||||1.06|0.43|0.0830
71027614|NCT01984242|141561783|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.7141|TWO_SIDED|95.0|0.7|1.69|||Log Rank|||||1.69|0.70|0.7141
71027615|NCT01984242|141561785|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.2541||95.0|0.59|1.15|||Log Rank|||||1.15|0.59|0.2541
71027616|NCT01984242|141561785|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.3103|TWO_SIDED|95.0|0.86|1.63|||Log Rank|||||1.63|0.86|0.3103
71027617|NCT01984242|141561787|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.0351|TWO_SIDED|95.0|0.37|0.97|||Log Rank|||||0.97|0.37|0.0351
71027618|NCT01984242|141561787|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9769||95.0|0.64|1.54|||Log Rank|||||1.54|0.64|0.9769
71027619|NCT01984242|141561788|SUPERIORITY||Difference in response rates|2.97||||0.6492|TWO_SIDED|95.0|-10.68|16.62|||Cochran-Mantel-Haenszel|||||16.62|-10.68|0.6492
71027620|NCT01984242|141561788|SUPERIORITY||Difference in response rates|-3.47||||0.5433||95.0|-16.63|9.69|||Cochran-Mantel-Haenszel|||||9.69|-16.63|0.5433
71027621|NCT01984242|141561789|SUPERIORITY||Difference in response rates|19.33||||0.0141|TWO_SIDED|95.0|-0.28|38.94|||Cochran-Mantel-Haenszel|||||38.94|-0.28|0.0141
71027622|NCT01984242|141561789|SUPERIORITY||Difference in response rates|1.11||||0.8719|TWO_SIDED|95.0|-17.02|19.24|||Cochran-Mantel-Haenszel|||||19.24|-17.02|0.8719
71027623|NCT01984242|141561790|SUPERIORITY||Difference in response rates|1.98||||0.8068|TWO_SIDED|95.0|-12.04|16.0|||Cochran-Mantel-Haenszel|||||16.00|-12.04|0.8068
71027624|NCT01984242|141561790|SUPERIORITY||Difference in response rates|-9.37||||0.1321||95.0|-22.61|3.87|||Cochran-Mantel-Haenszel|||||3.87|-22.61|0.1321
71027625|NCT01984242|141561791|SUPERIORITY||Difference in response rates|19.67||||0.0199|TWO_SIDED|95.0|-0.1|39.44|||Cochran-Mantel-Haenszel|||||39.44|-0.10|0.0199
71027626|NCT01984242|141561791|SUPERIORITY||Difference in response rates|-2.41||||0.7836|TWO_SIDED|95.0|-20.5|15.68|||Cochran-Mantel-Haenszel|||||15.68|-20.50|0.7836
71027627|NCT01984242|141561792|SUPERIORITY||Difference in response rates|3.96||||0.6231|TWO_SIDED|95.0|-10.23|18.15|||Cochran-Mantel-Haenszel|||||18.15|-10.23|0.6231
71027628|NCT01984242|141561792|SUPERIORITY||Difference in response rates|-8.42||||0.1816|TWO_SIDED|95.0|-21.86|5.02|||Cochran-Mantel-Haenszel|||||5.02|-21.86|0.1816
71109559|NCT02722408|141724365|OTHER|||||||0.5821||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.5821
71027629|NCT01984242|141561793|SUPERIORITY||Difference in response rates|22.0||||0.0111|TWO_SIDED|95.0|2.11|41.89|||Cochran-Mantel-Haenszel|||||41.89|2.11|0.0111
71027630|NCT01984242|141561793|SUPERIORITY||Difference in response rates|-2.22||||0.8209|TWO_SIDED|95.0|-20.63|16.19|||Cochran-Mantel-Haenszel|||||16.19|-20.63|0.8209
71027631|NCT01984242|141561795|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0863||95.0|0.5|1.05|||Log Rank|||||1.05|0.50|0.0863
71027632|NCT01984242|141561795|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.5922|TWO_SIDED|95.0|0.77|1.57|||Log Rank|||||1.57|0.77|0.5922
71027633|NCT01984242|141561797|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.0021||95.0|0.25|0.75|||Log Rank|||||0.75|0.25|0.0021
71027634|NCT01984242|141561797|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.6566|TWO_SIDED|95.0|0.56|1.44|||Log Rank|||||1.44|0.56|0.6566
71027635|NCT01984242|141561805|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.2867|TWO_SIDED|95.0|0.8|2.13|||Log Rank|||||2.13|0.80|0.2867
71027636|NCT01984242|141561805|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.8039||95.0|0.65|1.73|||Log Rank|||||1.73|0.65|0.8039
71027637|NCT01984242|141561807|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.7879|TWO_SIDED|95.0|0.47|1.78|||Log Rank|||||1.78|0.47|0.7879
71027638|NCT01984242|141561807|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.9065|TWO_SIDED|95.0|0.52|1.8|||Log Rank|||||1.80|0.52|0.9065
71027639|NCT04543136|141561822|SUPERIORITY||Mean Difference (Final Values)|45.0||||0.074|TWO_SIDED|95.0|-4.5|94.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||94.5|-4.5|0.074
71027640|NCT04543136|141561822|SUPERIORITY||Mean Difference (Final Values)|58.8||||0.022|TWO_SIDED|95.0|8.5|109.1||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||109.1|8.5|0.022
71027641|NCT04543136|141561822|SUPERIORITY||Mean Difference (Final Values)|-13.8||||0.587|TWO_SIDED|95.0|-64.2|36.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||36.6|-64.2|0.587
71027642|NCT04543136|141561823|SUPERIORITY||Mean Difference (Final Values)|54.9||||0.03|TWO_SIDED|95.0|5.3|104.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||104.4|5.3|0.030
71027643|NCT04543136|141561823|SUPERIORITY||Mean Difference (Final Values)|61.8||||0.015|TWO_SIDED|95.0|12.5|111.2||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||111.2|12.5|0.015
71027644|NCT04543136|141561823|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.78|TWO_SIDED|95.0|-56.5|42.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||42.5|-56.5|0.780
71027645|NCT04543136|141561824|SUPERIORITY||Mean Difference (Final Values)|-13.3||||0.281|TWO_SIDED|95.0|-37.9|11.2||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||11.2|-37.9|0.281
71027646|NCT04543136|141561824|SUPERIORITY||Mean Difference (Final Values)|6.6||||0.597|TWO_SIDED|95.0|-18.3|31.7||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||31.7|-18.3|0.597
71027647|NCT04543136|141561824|SUPERIORITY||Mean Difference (Final Values)|-20.0||||0.116|TWO_SIDED|95.0|-45.1|5.0||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||5.0|-45.1|0.116
71027648|NCT04543136|141561825|SUPERIORITY||Mean Difference (Final Values)|3.3||||0.787|TWO_SIDED|95.0|-21.2|27.9||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||27.9|-21.2|0.787
71027649|NCT04543136|141561825|SUPERIORITY||Mean Difference (Final Values)|6.8||||0.576|TWO_SIDED|95.0|-17.6|31.3||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||31.3|-17.6|0.576
71027650|NCT04543136|141561825|SUPERIORITY||Mean Difference (Final Values)|-3.5||||0.775|TWO_SIDED|95.0|-28.1|21.0||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||21.0|-28.1|0.775
71109560|NCT02722408|141724365|OTHER|||||||0.8881||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.8881
71109561|NCT02722408|141724365|OTHER|||||||0.8525||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.8525
71109562|NCT02722408|141724365|OTHER|||||||0.0112||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0112
71027651|NCT04543136|141561826|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.766|TWO_SIDED|95.0|-0.7|0.52||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.52|-0.70|0.766
71027652|NCT04543136|141561826|SUPERIORITY||Mean Difference (Final Values)|-0.68||||0.032|TWO_SIDED|95.0|-1.3|-0.06||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||-0.06|-1.30|0.032
71027653|NCT04543136|141561826|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.063|TWO_SIDED|95.0|-0.03|1.21||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.21|-0.03|0.063
71109563|NCT02722408|141724365|OTHER|||||||0.0018||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0018
71109564|NCT02722408|141724365|OTHER|||||||0.0028||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH).||||0.0028
71109565|NCT02722408|141724366|OTHER|||||||0.8985||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.8985
71109566|NCT02722408|141724366|OTHER|||||||0.7664||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.7664
70935907|NCT03976323|141372832|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.9156|TWO_SIDED|95.0|0.74|1.31||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.31|0.74|0.9156
71059795|NCT03417687|141626752|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-5.0%, +5.0%).|Mean Difference (Final Values)|3.71|STANDARD_DEVIATION|4.39|||TWO_SIDED|95.0|2.12|5.29||||||||5.29|2.12|
71059796|NCT03417687|141626753|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-5.0%, +5.0%).|Mean Difference (Final Values)|0.39|STANDARD_DEVIATION|2.4|||TWO_SIDED|95.0|-0.476|1.26||||||||1.26|-0.476|
71059797|NCT03417687|141626754|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-5.0%, +5.0%).|Mean Difference (Final Values)|1.35|STANDARD_DEVIATION|3.22|||TWO_SIDED|95.0|0.184|2.505||||||||2.505|0.184|
71059798|NCT03417687|141626755|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-5.0%, +5.0%).|Mean Difference (Final Values)|-0.96|STANDARD_DEVIATION|3.16|||TWO_SIDED|95.0|-2.101|0.181||||||||0.181|-2.101|
71059799|NCT03417687|141626756|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-5.0%, +5.0%).|Mean Difference (Final Values)|-2.721|STANDARD_DEVIATION|3.82|||TWO_SIDED|95.0|-4.096|-1.345||||||||-1.345|-4.096|
71059800|NCT03417687|141626757|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-5.0%, +5.0%).|Mean Difference (Final Values)|-1.76|STANDARD_DEVIATION|3.96|||TWO_SIDED|95.0|-3.192|-0.335||||||||-0.335|-3.192|
71059801|NCT00681031|141626764|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptability was demonstrated if the lower bound of the two-sided 95% confidence interval (CI) on the Geometric Mean Fold Rise (CMFR) from pre-vaccination to 4 weeks postvaccination is \>1.4.|GMFR|3.1|||||TWO_SIDED|95.0|2.6|3.8|||||GMFR = GMT postdose divided by GMT predose|||3.8|2.6|
71059802|NCT03953612|141626778|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Linear mixed effects||||||<.001
70852286|NCT01994889|141193113|SUPERIORITY||Least Square Mean Difference|75.68|STANDARD_ERROR_OF_MEAN|9.236|<|0.0001|TWO_SIDED|95.0|57.56|93.8|||Mixed Model Repeated Measures ANCOVA|||L.S. means are from an ANCOVA (MMRM) model with an unstructured covariance matrix; center and participant within center as random effects; treatment, visit, TTR genotype (variant and wild-type), and visit by treatment interaction, as fixed effects and baseline score as covariate.||93.80|57.56|<.0001
71059803|NCT03953612|141626779|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Linear mixed effects||||||<.001
71059804|NCT03953612|141626780|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|Linear mixed effects||||||0.7
70852287|NCT01994889|141193114|SUPERIORITY||LS Mean Difference|13.65|STANDARD_ERROR_OF_MEAN|2.13|<|0.0001|TWO_SIDED|95.0|9.48|17.83|||Mixed Model Repeated Measures ANCOVA|||Change at Month 30||17.83|9.48|<.0001
71059805|NCT03953612|141626781|SUPERIORITY|||||||0.0001|||||||ANOVA|||||||0.0001
71059806|NCT03953612|141626782|SUPERIORITY|||||||0.042|||||||. Negative binomial regression models|||||||0.042
71059807|NCT03953612|141626783|SUPERIORITY|||||||0.125|||||||. Negative binomial regression models|||||||0.125
70935908|NCT03976323|141372833|SUPERIORITY||Difference in LS Means|-0.01||||0.9962|TWO_SIDED|95.0|-2.94|2.93||Two-sided p-value based on t test.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||2.93|-2.94|0.9962
70935909|NCT03976323|141372834|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.5517|TWO_SIDED|95.0|0.83|1.4||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.40|0.83|0.5517
70935910|NCT00535626|141372835|OTHER|"To test if revision rate at 5 years is less than 10% (Ha - Alternative Hypothesis).~Note: All cases enrolled in the study had to undergo revision whether from their primary procedure or a previous revision. Based on literature, 10% is the expected rate of another revision occurring in this cohort of enrolled patients."|Revision or Pending Revision Rate|2.43|||||TWO_SIDED|90.0|1.07|5.46|||||The estimated 2.43% revision rate was obtained by the Kaplan-Meier method.|||5.46|1.07|
70935911|NCT00535626|141372836|OTHER|To test if the change from the pre-operative HHS compared to the post-operative HHS at all intervals is statistically significant.|||||<|0.0001||||||This p-value applies to all intervals.|t-test, 2 sided|Paired t-test||||||<0.0001
70935912|NCT00535626|141372837|OTHER|To test whether the change from the pre-operative SF-36 Physical Score compared to each post-operative SF-36 Physical score is statistically significant.|||||<|0.0001||||||This p-value applies to all intervals.|t-test, 2 sided|Paired t-test||||||<0.0001
70935913|NCT00535626|141372837|OTHER|To test whether the change from the pre-operative SF-36 Mental Score compared to the 3 month SF-36 Mental Score is statistically significant.||||||0.0139|||||||t-test, 2 sided|Paired t-test||||||0.0139
70935914|NCT00535626|141372837|OTHER|To test whether the change from the pre-operative SF-36 Mental Score compared to the 1 year SF-36 Mental Score is statistically significant.||||||0.0254|||||||t-test, 2 sided|Paired t-test||||||0.0254
70935915|NCT00535626|141372837|OTHER|To test whether the change from the SF-36 Mental Score compared to the 2 year SF-36 Mental Score is statistically significant.||||||0.1506|||||||t-test, 2 sided|Paired t-test||||||0.1506
70935916|NCT00535626|141372837|OTHER|To test whether the change from the pre-operative SF-36 Mental Score compared to the 3 year SF-36 Mental Score is statistically significant.||||||0.0936|||||||t-test, 2 sided|Paired t-test||||||0.0936
70935917|NCT00535626|141372837|OTHER|To test if the change from the pre-operative SF-36 Mental Score compared to the 4 year SF-36 Mental Score is statistically significant.||||||0.0909|||||||t-test, 2 sided|Paired t-test||||||0.0909
71027654|NCT04543136|141561827|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.213|TWO_SIDED|95.0|-0.12|0.54||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.54|-0.12|0.213
70935918|NCT00535626|141372837|OTHER|To test whether the change from the pre-operative SF-36 Mental Score compared to the 5 year SF-36 Mental Score is statistically significant.||||||0.048|||||||t-test, 2 sided|Paired t-test||||||0.048
70935919|NCT00535626|141372840|OTHER|To test whether the change from the pre-operative LEAS Score compared to the 3 month LEAS Score is statistically significant.||||||0.0011|||||||t-test, 2 sided|Paired t-test||||||0.0011
70935920|NCT00535626|141372840|OTHER|To test whether the change from the pre-operative LEAS compared to the 1, 2 and 3 year LEAS are statistically significant.|||||<|0.0001||||||This p-value applies to pre-op to 1, 2 and 3 year intervals.|t-test, 2 sided|Paired t-test||||||<0.0001
70935921|NCT00535626|141372840|OTHER|To test whether the change from the pre-operative LEAS compared to the 4 year LEAS is statistically significant.||||||0.0002|||||||t-test, 2 sided|Paired t-test||||||0.0002
70935922|NCT00535626|141372840|OTHER|To test whether the change from the pre-operative LEAS compared to the 5 year LEAS is statistically significant.||||||0.0009|||||||t-test, 2 sided|Paired t-test||||||0.0009
70935923|NCT01190124|141372872|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Comparison between the 3 study groups, in order to determine if there are statistically significant differences concerning HIV-RNA levels at baseline||||<0.001
70935924|NCT01190124|141372875|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Kruskal-Wallis|||Comparison between the 3 study groups, in order to determine if there are statistically significant differences concerning CD4 cells count at baseline||||<0.001
70935925|NCT01190124|141372888|SUPERIORITY_OR_OTHER|||||||0.007|||||||Kruskal-Wallis|||Comparison between the 3 study groups, in order to determine if there are statistically significant differences concerning CD4 cells count at week 24||||0.007
70935926|NCT01190124|141372889|SUPERIORITY_OR_OTHER|||||||0.001|||||||Kruskal-Wallis|||Comparison between the 3 study groups, in order to determine if there are statistically significant differences concerning CD4 cells count at week 48||||0.001
70935927|NCT00070707|141372908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.101|||||||ANOVA|||Baseline (AM)||||0.101
70935928|NCT00070707|141372908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.168|||||||ANOVA|||Change at Week 1 (AM)||||0.168
70935929|NCT00070707|141372908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93|||||||ANOVA|||Change at Week 2 (AM)||||0.930
70935930|NCT00070707|141372908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.487|||||||ANOVA|||Change at Week 3 (AM)||||0.487
70935931|NCT00070707|141372908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.914|||||||ANOVA|||Change at Week 4 (AM)||||0.914
70935932|NCT00070707|141372908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.977|||||||ANOVA|||Change at Final Week (AM)||||0.977
71027655|NCT04543136|141561827|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.291|TWO_SIDED|95.0|-0.16|0.51||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.51|-0.16|0.291
71027656|NCT04543136|141561827|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.868|TWO_SIDED|95.0|-0.31|0.36||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.36|-0.31|0.868
71027657|NCT04543136|141561828|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.661|TWO_SIDED|95.0|-0.35|0.55||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.55|-0.35|0.661
71027658|NCT04543136|141561828|SUPERIORITY||Mean Difference (Final Values)|-0.29||||0.218|TWO_SIDED|95.0|-0.75|0.17||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.17|-0.75|0.218
71027659|NCT04543136|141561828|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.1|TWO_SIDED|95.0|-0.08|0.85||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.85|-0.08|0.100
71027660|NCT04543136|141561829|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.701|TWO_SIDED|95.0|-0.8|0.54||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.54|-0.80|0.701
71027661|NCT04543136|141561829|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.438|TWO_SIDED|95.0|-0.96|0.42||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.42|-0.96|0.438
71027662|NCT04543136|141561829|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.689|TWO_SIDED|95.0|-0.55|0.83||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.83|-0.55|0.689
70935933|NCT00070707|141372908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.109|||||||ANOVA|||Baseline (PM)||||0.109
71059808|NCT02028676|141626785|NON_INFERIORITY_OR_EQUIVALENCE|Upper 95% confidence interval for the hazard ratio was 1.64, see other analysis for this endpoint for details|Hazard Ratio (HR)|1.13||||0.59|TWO_SIDED|95.0|0.73|1.73|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.73|0.73|0.59
71059809|NCT02028676|141626785|NON_INFERIORITY_OR_EQUIVALENCE|With assumptions detailed above, \>90% power and one-sided alpha=0.05, 1160 children would be required to exclude an increase in progression rate of 1.6% from 2.5% to 4.1% per year in the CDM arm (upper 95% confidence limit of LCM: CDM hazard ratio 1.64).|Risk Difference (RD)|0.32||||0.43|TWO_SIDED|95.0|-0.47|1.12|||Comparison of poisson rates|Statistical analysis plan specified that p-value was to be calculated from the log-rank test, so not provided for the risk difference|Difference is CDM minus LCM|"Assumptions:~* control group (LCM) event rate 3% per year~* rates are reduced to 2% per year in the best of the induction-maintenance arms leading to an overall rate of progression to new WHO stage 4 or death of 2.5%~* recruitment is over 1.5 years and follow-up for a minimum further 3.5 years.~* cumulative loss to follow-up is 10% at 5 years. See below for rest of sample size as this box is not big enough."||1.12|-0.47|0.43
71027663|NCT04543136|141561830|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.309|TWO_SIDED|95.0|-0.92|0.3||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.30|-0.92|0.309
71059810|NCT02028676|141626786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.83|TWO_SIDED|95.0|0.83|1.16|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.16|0.83|0.83
71109567|NCT02722408|141724366|OTHER|||||||0.4755||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.4755
71109568|NCT02722408|141724366|OTHER|||||||0.2286||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.2286
71027664|NCT04543136|141561830|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.109|TWO_SIDED|95.0|-1.1|0.11||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.11|-1.10|0.109
71109569|NCT02722408|141724366|OTHER|||||||0.3975||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.3975
70935934|NCT00070707|141372908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.291|||||||ANOVA|||Change at Week 1 (PM)||||0.291
70935935|NCT00070707|141372908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.984|||||||ANOVA|||Change at Week 2 (PM)||||0.984
70935936|NCT00070707|141372908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.373|||||||ANOVA|||Change at Week 3 (PM)||||0.373
70935937|NCT00070707|141372908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.623|||||||ANOVA|||Change at Week 4 (PM)||||0.623
70935938|NCT00070707|141372908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.978|||||||ANOVA|||Change at Final Week (PM)||||0.978
70935939|NCT00070707|141372909|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|||||||ANOVA|||Baseline (AM)||||0.023
70935940|NCT00070707|141372909|SUPERIORITY_OR_OTHER_LEGACY|||||||0.693|||||||ANOVA|||Change at Week 1 (AM)||||0.693
70935941|NCT00070707|141372909|SUPERIORITY_OR_OTHER_LEGACY|||||||0.483|||||||ANOVA|||Change at Week 2 (AM)||||0.483
71027665|NCT04543136|141561830|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.555|TWO_SIDED|95.0|-0.43|0.79||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.79|-0.43|0.555
71027666|NCT04543136|141561831|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.896|TWO_SIDED|95.0|-0.35|0.31||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.31|-0.35|0.896
71027667|NCT04543136|141561831|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.32|TWO_SIDED|95.0|-0.49|0.16||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.16|-0.49|0.320
71027668|NCT04543136|141561831|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.39|TWO_SIDED|95.0|-0.19|0.47||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.47|-0.19|0.390
71059811|NCT02028676|141626787|SUPERIORITY_OR_OTHER|||||||0.33|||||||Regression, Linear|Global test with 2df, adjusted for randomization stratification factors||Assuming a standard deviation for the change in CD4 percentage from baseline to 72 weeks of 10% (slightly higher than that observed in the PENTA 5 trial) 1200 children would provide at least 80% power to detect a difference in change in CD4% from baseline of more than 2.5% across the 3 groups (F-test with 2-sided alpha=0.05) assuming 20% missing data (loss to follow-up during the first year plus failure to attend the week 72 visit/missing sample).||||0.33
71059812|NCT02028676|141626788|SUPERIORITY_OR_OTHER|||||||0.69|||||||Regression, Linear|Global test with 2df, adjusted for randomization stratification factors||||||0.69
71059813|NCT02028676|141626789|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.0001
71059814|NCT02028676|141626789|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.01|TWO_SIDED|95.0|1.07|1.63|||Regression, Cox||HR is Arm B vs A|||1.63|1.07|0.01
71059815|NCT02028676|141626789|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.58|||<|0.001|TWO_SIDED|95.0|1.29|1.94|||Regression, Cox|||||1.94|1.29|<0.001
71059816|NCT02028676|141626790|NON_INFERIORITY_OR_EQUIVALENCE|631 children would be required to exclude a 12% lower suppression rate in the once daily group with at least 90% power and two-sided alpha=0.05 (lower 95% confidence limit of difference between once and twice daily -12%, the non-inferiority margin). 630 children retains at least 80% (rather than 90%) power to exclude a 10% (rather than 12%) lower suppression rate in the once daily group with one-sided alpha=0.05 (lower 90% confidence limit of difference between once and twice daily -10%).|Risk Difference (RD)|-1.6||||0.65|TWO_SIDED|95.0|-8.4|5.2|||Chi-squared||Difference in suppression \<80 copies/ml in once-daily minus twice-daily|||5.2|-8.4|0.65
70935942|NCT00070707|141372909|SUPERIORITY_OR_OTHER_LEGACY|||||||0.088|||||||ANOVA|||Change at Week 3 (AM)||||0.088
70935943|NCT00070707|141372909|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21|||||||ANOVA|||Change at Week 4 (AM)||||0.210
70935944|NCT00070707|141372909|SUPERIORITY_OR_OTHER_LEGACY|||||||0.178|||||||ANOVA|||Change at Final Week (AM)||||0.178
70935945|NCT00070707|141372909|SUPERIORITY_OR_OTHER_LEGACY|||||||0.055|||||||ANOVA|||Baseline (PM)||||0.055
70935946|NCT00070707|141372909|SUPERIORITY_OR_OTHER_LEGACY|||||||0.915|||||||ANOVA|||Change at Week 1 (PM)||||0.915
70935947|NCT00070707|141372909|SUPERIORITY_OR_OTHER_LEGACY|||||||0.471|||||||ANOVA|||Change at Week 2 (PM)||||0.471
70935948|NCT00070707|141372909|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11|||||||ANOVA|||Change at Week 3 (PM)||||0.110
70935949|NCT00070707|141372909|SUPERIORITY_OR_OTHER_LEGACY|||||||0.305|||||||ANOVA|||Change at Week 4 (PM)||||0.305
70935950|NCT00070707|141372909|SUPERIORITY_OR_OTHER_LEGACY|||||||0.461|||||||ANOVA|||Change at Final Week (PM)||||0.461
70935951|NCT00070707|141372910|SUPERIORITY_OR_OTHER_LEGACY|||||||0.068|||||||ANOVA|||Baseline (AM)||||0.068
70935952|NCT00070707|141372910|SUPERIORITY_OR_OTHER_LEGACY|||||||0.116|||||||ANOVA|||Change at Week 1 (AM)||||0.116
70935953|NCT00070707|141372910|SUPERIORITY_OR_OTHER_LEGACY|||||||0.749|||||||ANOVA|||Change at Week 2 (AM)||||0.749
70935954|NCT00070707|141372910|SUPERIORITY_OR_OTHER_LEGACY|||||||0.289|||||||ANOVA|||Change at Week 3 (AM)||||0.289
70935955|NCT00070707|141372910|SUPERIORITY_OR_OTHER_LEGACY|||||||0.982|||||||ANOVA|||Change at Week 4 (AM)||||0.982
70935956|NCT00070707|141372910|SUPERIORITY_OR_OTHER_LEGACY|||||||0.941|||||||ANOVA|||Change at Final Week (AM)||||0.941
71027669|NCT04543136|141561832|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.802|TWO_SIDED|95.0|-0.51|0.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.40|-0.51|0.802
70935957|NCT00070707|141372910|SUPERIORITY_OR_OTHER_LEGACY|||||||0.128|||||||ANOVA|||Baseline (PM)||||0.128
71027670|NCT04543136|141561832|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.082|TWO_SIDED|95.0|-0.85|0.05||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.05|-0.85|0.082
71027671|NCT04543136|141561832|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.137|TWO_SIDED|95.0|-0.11|0.8||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.80|-0.11|0.137
71027672|NCT04543136|141561833|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.525|TWO_SIDED|95.0|-0.89|0.46||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.46|-0.89|0.525
71027673|NCT04543136|141561833|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.098|TWO_SIDED|95.0|-1.24|0.11||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.11|-1.24|0.098
71027674|NCT04543136|141561833|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.306|TWO_SIDED|95.0|-0.33|1.02||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.02|-0.33|0.306
71027675|NCT00585780|141561834|OTHER|Expected outcome was that Prazosin will be better than placebo in reducing HDD% among High AW individuals but no differences by medication treatment in the Low AW individuals.|Odds Ratio (OR)|0.23||||0.016|TWO_SIDED|95.0|0.1|0.55||This is for the apriori hypothesis of significant AWX Treatment X Time effect.|Mixed Models Analysis|Simple effects were conducted to assess source of the interaction.||Intent-to-treat (ITT) analyses with baseline AW severity (mean-centered continuous CIWA-Ar scores) as a moderator of Time (Pre-Full Dose(FD): weeks 1-2; Post FD: weeks 3-12) were conducted with linear or generalized linear mixed effect (LME/GLME) piecewise growth models for continuous and binary outcomes. Control variables that were modeled in all analyses. As hypothesized, significant interactions were tested using AW median cut-offs for high and Low AW groups.||0.55|0.1|0.016
71027676|NCT00585780|141561835|OTHER|Expected outcome was that Prazosin will be better than placebo in reducing percent of drinking days (DD%) among High AW individuals but no differences by medication treatment in the Low AW individuals.|Odds Ratio (OR)|0.5||||0.002|TWO_SIDED|95.0|0.28|0.92||This is for apriori hypothesized significant AW X Treatment X Post-full dose time interaction effect.|Mixed Models Analysis|||Intent-to-treat (ITT) analyses with baseline AW severity (mean-centered continuous CIWA-Ar scores) as a moderator of Time (Pre-Full Dose(FD): weeks 1-2; Post FD: weeks 3-12) were conducted with linear or generalized linear mixed effect (LME/GLME) piecewise growth models for continuous and binary outcomes. Control variables that were modeled in all analyses. As hypothesized, significant interactions were tested using AW median cut-offs for high and Low AW groups.||0.92|0.28|0.002
71027677|NCT00947427|141561836|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86|||||||ANCOVA|||||||0.86
71027678|NCT00865709|141561837|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.884||||0.2309|TWO_SIDED|95.0|0.635|1.231||1-sided p-value from stratified log-rank test, stratified by factors of # metastatic sites and liver metastasis determined by Principal Investigator|Log Rank||The relative risk (sorafenib to placebo) was estimated by the hazard ratio from stratified Cox regression with a 95% confidence interval.|A sample size of 120 PFS events would provide a \> 85% power at a target HR = 0.65 between sorafenib and matching placebo, with a 1-sided alpha = 0.10, for testing the null hypothesis H0: HR ≥ 1 versus the alternative hypothesis H1: HR \< 1 based on the log-rank test. The test was conducted using the intent-to-treat (ITT) population, defined as all subjects who were randomized to treatment.||1.231|0.635|0.2309
71027679|NCT00865709|141561839|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.829||||0.1437|TWO_SIDED|95.0|0.586|1.174||1-sided p-value from stratified log-rank test, stratified by factors of # metastatic sites and liver metastasis determined by Principal Investigator|Log Rank||The relative risk (sorafenib to placebo) was estimated by the hazard ratio from stratified Cox regression with a 95% confidence interval.|A sample size of 120 PDs would provide a \> 85% power at a target HR = 0.65 between sorafenib and matching placebo, with a 1-sided alpha = 0.10, for testing H0: HR ≥ 1 versus H1: HR \< 1 based on the log-rank test. The test was conducted using the intent-to-treat (ITT) population (all subjects who were randomized).||1.174|0.586|0.1437
71027680|NCT00865709|141561840|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||1-sided p-value from the Cochran-Mantel-Haenszel test, adjusting for the stratification factors of # metastatic sites and liver metastasis determined by Principal Investigator|Cochran-Mantel-Haenszel|||The proportion of subjects achieving overall response (CR or PR), when confirmation of response was not required, was estimated with a 95% confidence interval for each treatment group. The treatment groups were compared with respect to overall response rate using the Cochran-Mantel-Haenszel test, adjusting for the stratification factors.||||0.023
71027681|NCT00429923|141561842|SUPERIORITY_OR_OTHER|||||||0.0014||95.0|||||Mantel Haenszel|||||||0.0014
71027682|NCT01041781|141561846|SUPERIORITY||Hazard Ratio (HR)|1.076||||0.5346|TWO_SIDED|95.0|0.853|1.367|||Log Rank|||||1.367|0.853|0.5346
71027683|NCT01041781|141561850|SUPERIORITY|||||||0.0049|||||||Log Rank|||||||0.0049
71027684|NCT01041781|141561851|SUPERIORITY|||||||0.0131|||||||Log Rank|||||||0.0131
71027685|NCT01041781|141561852|SUPERIORITY|||||||0.0322|||||||Log Rank|||||||0.0322
71027686|NCT00662129|141561859|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
71027687|NCT02099461|141561874|SUPERIORITY_OR_OTHER||LS Mean|0.15||||0.2966|TWO_SIDED|95.0|-0.136|0.441|||ANCOVA|||An ANCOVA analysis was performed on the log ratio of post-baseline to baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.||0.441|-0.136|0.2966
71027688|NCT02099461|141561874|SUPERIORITY_OR_OTHER||LS Mean|-0.16||||0.2769|TWO_SIDED|95.0|-0.447|0.13|||ANCOVA|||An ANCOVA analysis was performed on the log ratio of post-baseline to baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.||0.130|-0.447|0.2769
70935958|NCT00070707|141372910|SUPERIORITY_OR_OTHER_LEGACY|||||||0.484|||||||ANOVA|||Change at Week 1 (PM)||||0.484
71027689|NCT02099461|141561874|SUPERIORITY_OR_OTHER||LS Mean|-0.09||||0.5238|TWO_SIDED|95.0|-0.373|0.191|||ANCOVA|||An ANCOVA analysis was performed on the log ratio of post-baseline to baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.||0.191|-0.373|0.5238
71027690|NCT02099461|141561874|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31||||0.1343|TWO_SIDED|95.0|-0.72|0.098|||ANCOVA||Denosumab 60 mg - Placebo|An ANCOVA analysis was performed on the log ratio of post-baseline to Baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.||0.098|-0.720|0.1343
70935959|NCT00070707|141372910|SUPERIORITY_OR_OTHER_LEGACY|||||||0.673|||||||ANOVA|||Change at Week 2 (PM)||||0.673
71027691|NCT02099461|141561874|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24||||0.2345|TWO_SIDED|95.0|-0.646|0.161|||ANCOVA||Denosumab 120 mg - Placebo|An ANCOVA analysis was performed on the log ratio of post-baseline to Baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.||0.161|-0.646|0.2345
71027692|NCT00720122|141561877|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.00558|STANDARD_ERROR_OF_MEAN|0.00653||0.4|TWO_SIDED|95.0|-0.0081|0.0193|||Paired t-test|||A paired t-test was performed. The null hypothesis was that bone density would decrease over 6 months in females with anorexia nervosa, as observed in life course studies.||0.0193|-0.0081|0.40
71027693|NCT02579096|141561878|NON_INFERIORITY|A non-inferiority bound of 8% was established during the trial design; a one-sided alpha level was set at 0.05.|Risk Difference (RD)|-7.0|||<|0.001|ONE_SIDED|95.0||-1.2|||t-test, 1 sided|||One-sided null hypothesis posited that allopurinol was inferior to febuxostat. The proportions of participants with ≥ 1 gout flare during phase 3 were compared between the two treatments.||-1.2||<0.001
71027694|NCT00663871|141561892|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.04||||0.59|TWO_SIDED|95.0|-0.27|0.19|||ANOVA|||||0.19|-0.27|0.59
71027695|NCT00663871|141561893|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.05||||0.21|TWO_SIDED|95.0|-0.24|0.19|||ANOVA|||||0.19|-0.24|0.21
71027696|NCT00663871|141561894|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.02||||0.92|TWO_SIDED|95.0|0.69|1.5||The model included effects of treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time. The Negative Affect scores were categorized by quartiles of the baseline measures.|Mixed Models Analysis|Generalized Linear Mixed Modeling was used with a multinomial distribution with cumulative link.||||1.50|0.69|0.92
71027697|NCT00663871|141561895|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.12||||0.86|TWO_SIDED|95.0|-1.21|1.44||The model included effects of treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mixed Models Analysis|||||1.44|-1.21|0.86
71027698|NCT00663871|141561896|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.31||||0.63|TWO_SIDED|95.0|-1.57|0.94||The model included effects of treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mixed Models Analysis|||||0.94|-1.57|0.63
71027699|NCT00663871|141561897|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.32||||0.5|TWO_SIDED|95.0|-1.25|0.61||The model included effects of treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mixed Models Analysis|||||0.61|-1.25|0.50
71027700|NCT00663871|141561898|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.33||||0.25|TWO_SIDED|95.0|-0.23|0.88||The model included effects of treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mixed Models Analysis|||||0.88|-0.23|0.25
71027701|NCT00663871|141561899|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.45||||0.52|TWO_SIDED|95.0|-1.83|0.92||The model included effects of treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mixed Models Analysis|||||0.92|-1.83|0.52
71109570|NCT02722408|141724366|OTHER|||||||0.446||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.4460
70935960|NCT00070707|141372910|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|||||||ANOVA|||Change at Week 3 (PM)||||0.250
70935961|NCT00070707|141372910|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45|||||||ANOVA|||Change at Week 4 (PM)||||0.450
70935962|NCT00070707|141372910|SUPERIORITY_OR_OTHER_LEGACY|||||||0.774|||||||ANOVA|||Change at Final Week (PM)||||0.774
70935963|NCT00070707|141372911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.078|||||||ANOVA|||Baseline (AM)||||0.078
70935964|NCT00070707|141372911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.492|||||||ANOVA|||Change at Week 1 (AM)||||0.492
70852288|NCT01994889|141193115|SUPERIORITY||Hazard Ratio (HR)|0.691||||0.0383|TWO_SIDED|95.0|0.488|0.98|||Cox proportional hazards model||Hazard ratio from a Cox proportional hazards model with treatment, TTR genotype (variant and wild-type) and NYHA baseline classification (NYHA Classes I and II combined and NYHA Class III) in the model.|||0.980|0.488|0.0383
71027702|NCT00663871|141561900|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.22||||0.52|TWO_SIDED|95.0|0.67|2.24||The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time. The Type A personality scores were categorized by quartiles of the baseline measures.|Mixed Models Analysis|Generalized Linear Mixed Modeling was used with a multinomial distribution with cumulative link.||||2.24|0.67|0.52
71027703|NCT00663871|141561901|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.03||||0.68|TWO_SIDED|95.0|-0.16|0.1||The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mixed Models Analysis|||||0.10|-0.16|0.68
71027704|NCT00663871|141561902|SUPERIORITY_OR_OTHER_LEGACY|The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mean Difference (Net)|-0.17||||0.16|TWO_SIDED|95.0|-0.41|0.07|||Mixed Models Analysis|||||0.07|-0.41|0.16
71027705|NCT00663871|141561903|SUPERIORITY_OR_OTHER_LEGACY|The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mean Difference (Net)|-0.05||||0.59|TWO_SIDED|95.0|-0.24|0.14|||Mixed Models Analysis|||||0.14|-0.24|0.59
71027706|NCT00663871|141561904|SUPERIORITY_OR_OTHER_LEGACY|The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mean Difference (Net)|0.06||||0.35|TWO_SIDED|95.0|-0.06|0.18|||Mixed Models Analysis|||||0.18|-0.06|0.35
71027707|NCT00663871|141561905|SUPERIORITY_OR_OTHER_LEGACY|The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mean Difference (Net)|0.04||||0.74|TWO_SIDED|95.0|-0.18|0.25|||Mixed Models Analysis|||||0.25|-0.18|0.74
71027708|NCT00663871|141561906|SUPERIORITY_OR_OTHER_LEGACY|The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mean Difference (Net)|-0.1||||0.28|TWO_SIDED|95.0|-0.27|0.08|||Mixed Models Analysis|||||0.08|-0.27|0.28
71027709|NCT00663871|141561907|SUPERIORITY_OR_OTHER_LEGACY||standardized mean difference|0.15||||0.76|TWO_SIDED|95.0|-0.09|0.39|||Repeated Measures MANOVA|||||0.39|-0.09|0.76
71027710|NCT00663871|141561908|SUPERIORITY_OR_OTHER_LEGACY||standardized mean difference|0.06||||0.62|TWO_SIDED|95.0|-0.18|0.3|||Repeated Measures MANOVA|||||0.30|-0.18|0.62
71027711|NCT00663871|141561909|SUPERIORITY_OR_OTHER_LEGACY||standardized mean difference|0.03||||0.42|TWO_SIDED|95.0|-0.21|0.26|||Repeated Measures MANOVA|||||0.26|-0.21|0.42
71027712|NCT00663871|141561910|SUPERIORITY_OR_OTHER_LEGACY||Standardized mean difference|-0.06||||0.54|TWO_SIDED|95.0|-0.3|0.18|||Repeated Measures MANOVA|Repeated Measures MANOVA||||0.18|-0.30|0.54
71027713|NCT04828161|141561980|SUPERIORITY||Least square (LS) mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.138|<|0.001|TWO_SIDED|95.0|-0.86|-0.32|||ANCOVA|||||-0.32|-0.86|<0.001
71027714|NCT04828161|141561980|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.135||0.014|TWO_SIDED|95.0|-0.6|-0.07|||ANCOVA|||||-0.07|-0.60|0.014
71027715|NCT04828161|141561980|SUPERIORITY||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.135||0.002|TWO_SIDED|95.0|-0.68|-0.15|||ANCOVA|||||-0.15|-0.68|0.002
71027716|NCT05431153|141561998|OTHER||Ratio of adjusted geometric means|98.83|||||TWO_SIDED|90.0|94.0|103.91|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||103.91|94.00|
71027717|NCT05431153|141561998|OTHER||Ratio of adjusted geometric means|98.02|||||TWO_SIDED|90.0|93.88|102.35|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||102.35|93.88|
71027718|NCT05431153|141561998|OTHER||Ratio of adjusted geometric means|98.51|||||TWO_SIDED|90.0|91.79|105.73|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||105.73|91.79|
71027719|NCT05431153|141561999|OTHER||Ratio of adjusted geometric means|96.35|||||TWO_SIDED|90.0|87.48|106.12|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||106.12|87.48|
71027720|NCT05431153|141561999|OTHER||Ratio of adjusted geometric means|93.47|||||TWO_SIDED|90.0|85.65|102.0|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||102.00|85.65|
71027721|NCT05431153|141561999|OTHER||Ratio of adjusted geometric means|98.01|||||TWO_SIDED|90.0|89.86|106.9|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||106.90|89.86|
71027722|NCT05431153|141562000|OTHER||Ratio of adjusted geometric means|111.52|||||TWO_SIDED|90.0|99.55|124.93|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||124.93|99.55|
71027723|NCT05431153|141562000|OTHER||Ratio of adjusted geometric means|98.38|||||TWO_SIDED|90.0|90.68|106.73|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||106.73|90.68|
71027724|NCT05431153|141562001|OTHER||Ratio of adjusted geometric means|111.52|||||TWO_SIDED|90.0|96.46|128.93|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||128.93|96.46|
71027725|NCT05431153|141562001|OTHER||Ratio of adjusted geometric means|81.39|||||TWO_SIDED|90.0|75.06|88.26|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||88.26|75.06|
71027726|NCT01082952|141562066|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||The p value is calculated for the results of ASM proliferation following incubation with eosinophils isolated from patients in each group. p\< 0.05 was considered significant.|ANOVA|Proliferation data was evaluated using two-way factorial ANOVA followed by Bonferroni post hoc test.||||||<0.05
70852289|NCT01994889|141193116|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
70935965|NCT00070707|141372911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.945|||||||ANOVA|||Change at Week 2 (AM)||||0.945
71027727|NCT03093454|141562068|EQUIVALENCE|Linear mixed effects models were used to investigate HADS scores (total, anxiety, and depression), sleep scores, and pain scores. Variables for time point (preoperative/Post-op Day 1/final Post-op Day) \& arm were analyzed. Adjustment for multiple pairwise comparisons used the Scheffe method. Analyses were conducted based on the intent to treat principle. P-values\<0.05 were considered statistically significant. Each time point, the mean and corresponding 95% confidence interval has been plotted.|Odds Ratio (OR)|95.0|STANDARD_DEVIATION|1.0||0.05|TWO_SIDED|95.0||||The p value is calculated and adjusted for multiple comparisons.|Fisher Exact|||Lavender group compared to control group||||0.05
71027728|NCT04540497|141562071|OTHER||Hazard Ratio (HR)|0.13|||||TWO_SIDED|95.0|0.06|0.28|||||Inebilizumab versus placebo|||0.28|0.06|
71027729|NCT04540497|141562078|OTHER||Hazard Ratio (HR)|0.12|||||TWO_SIDED|95.0|0.05|0.26|||||Inebilizumab vs placebo|||0.26|0.05|
71027730|NCT01681030|141562085|SUPERIORITY_OR_OTHER||Proportion|0.923|||||TWO_SIDED|95.0|0.64|0.998|||||CI for EVARREST Group|||0.998|0.640|
71027731|NCT01681030|141562085|SUPERIORITY_OR_OTHER||Proportion|0.333|||||TWO_SIDED|95.0|0.133|0.59|||||CI for Topical Hemostat group|||0.590|0.133|
71027732|NCT01681030|141562085|SUPERIORITY_OR_OTHER||Proportion|0.455|||||TWO_SIDED|95.0|0.167|0.766|||||CI for Standard of Care group|||0.766|0.167|
71027733|NCT01521559|141562113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|26.6||||0.0003|TWO_SIDED|95.0|13.0|40.1||P-value was calculated using 2-sided Cochran-Mantel-Haenszel test adjusted by regions (Japan vs North America) and baseline Best Corrected Visual Acuity (BCVA ≤20/200 and BCVA \>20/200).|Cochran-Mantel-Haenszel||Difference was IAI group minus laser group; Difference and confidence interval were calculated using Mantel-Haenszel weighting scheme adjusted by regions (Japan vs North America) and baseline BCVA (BCVA ≤20/200 and BCVA \>20/200).|||40.1|13.0|0.0003
71027734|NCT01521559|141562114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.5|||<|0.0001|TWO_SIDED|95.0|7.1|14.0|||ANCOVA|||Difference was IAI group minus laser group. P-value, Point estimate and 95% confidence interval (CI) were based on an analysis of covariance (ANCOVA) model with baseline measurement as covariate and treatment group, region, and baseline Best Corrected Visual Acuity (BCVA ≤20/200 and BCVA \>20/200) as fixed factors.||14.0|7.1|<0.0001
71027735|NCT01521559|141562115|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-148.6|||<|0.0001|TWO_SIDED|95.0|-179.8|-117.4|||ANCOVA|||Difference was IAI group minus laser group; P-value, Point estimate, and 95% CI, were based on an ANCOVA model with baseline measurement as covariate and treatment group, region, and baseline Best Corrected Visual Acuity (BCVA ≤20/200 and BCVA \>20/200) as fixed factors.||-117.4|-179.8|<0.0001
71027736|NCT01521559|141562116|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.6||||0.0833|TWO_SIDED|95.0|-0.3|5.5|||ANCOVA|||Difference was IAI group minus laser group; P-value, Point estimate, and 95% CI, were based on an ANCOVA model with baseline measurement as covariate and treatment group, region, and baseline Best Corrected Visual Acuity (BCVA ≤20/200 and BCVA \>20/200) as fixed factors.||5.5|-0.3|0.0833
71027737|NCT00520741|141562144|SUPERIORITY_OR_OTHER||Predicted exit rate at 112 days|0.3|||||TWO_SIDED|95.0|0.246|0.355|||Kaplan-Meier|Subjects who dropped out due to non-exit criteria reasons over the 10 % censoring maximum were to be counted as an exit.||The upper limit of the Confidence Interval for the estimate of the Lacosamide (LCM) 400 mg/day exit rate was compared with the lower bound of the 95 % prediction interval for the historical-control of 0.653; hereafter referred to as the historical-control exit rate. The LCM 400 mg/day dose group would be declared an effective conversion to monotherapy treatment if the upper 95 % confidence limit for the estimate of the exit rate was less than 0.653.||0.355|0.246|
71027738|NCT00520741|141562146|SUPERIORITY_OR_OTHER||predicted exit rate at 112 days|0.323|||||TWO_SIDED|95.0|0.268|0.378|||Kaplan-Meier|Subjects who dropped out due to non-exit criteria reasons over the 10 % censoring maximum were to be counted as an exit.||The upper limit of the Confidence Interval for the estimate of the Lacosamide (LCM) 400 mg/day exit rate was compared with the historical-control exit rate. The LCM 400 mg/day dose group would be declared an effective conversion to monotherapy treatment if the upper 95 % confidence limit for the estimate of the exit rate was less than 0.653.||0.378|0.268|
71027739|NCT02750761|141562164|OTHER|Bioavailability: Geometric least squares mean ratio between the Oral Group's and IV Group's dose normalized AUC from time zero to infinity.|Geometric Least Squares Mean Ratio|1.12|||||TWO_SIDED|90.0|0.93|1.35|||||The Oral Group represented the numerator in the bioavailability ratio, and the IV Group represented the denominator.|||1.35|0.93|
71027740|NCT00108732|141562219|SUPERIORITY_OR_OTHER||Percent|62.5|||||TWO_SIDED|90.0|48.3|75.3||||||||75.3|48.3|
70935966|NCT00070707|141372911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.359|||||||ANOVA|||Change at Week 3 (AM)||||0.359
70935967|NCT00070707|141372911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.802|||||||ANOVA|||Change at Week 4 (AM)||||0.802
70935968|NCT00070707|141372911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.716|||||||ANOVA|||Change at Final Week (AM)||||0.716
70935969|NCT00070707|141372911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.158|||||||ANOVA|||Baseline (PM)||||0.158
70935970|NCT00070707|141372911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.281|||||||ANOVA|||Change at Week 1 (PM)||||0.281
70935971|NCT00070707|141372911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.901|||||||ANOVA|||Change at Week 2 (PM)||||0.901
70935972|NCT00070707|141372911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.433|||||||ANOVA|||Change at Week 3 (PM)||||0.433
70935973|NCT00070707|141372911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.73|||||||ANOVA|||Change at Week 4 (PM)||||0.730
70935974|NCT00070707|141372911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.819|||||||ANOVA|||Change at Final Week (PM)||||0.819
71027741|NCT00108732|141562220|SUPERIORITY_OR_OTHER||Response rate (percent)|0.0|||||TWO_SIDED|90.0|0.0|7.2||||||||7.2|0|
71027742|NCT00108732|141562221|SUPERIORITY_OR_OTHER||median of difference|0.45||||0.003||95.0|||||Wilcoxon signed rank test|The Wilcoxon signed rank test was used to test the difference between day 4 PSA and day 15 PSA.||||||0.003
71027743|NCT00108732|141562222|SUPERIORITY_OR_OTHER||median of difference|-0.04||||0.02||95.0||||The Wilcoxon signed-rank test was used to test the difference between pre and post-treatment PSA slopes assessed by multiple PSA values on natural log scale using a piecewise linear model with a common knot point at the date of registration.|Wilcoxon signed rank test|||||||0.02
71059817|NCT02028676|141626792|NON_INFERIORITY_OR_EQUIVALENCE|With assumptions above, at least 80% power and one-sided alpha=0.05, 947 children would be required in the stop/continue cotrimoxazole prophylaxis comparison to exclude an increase in hospitalisation/death rate of 3% from 5% to 8% per year in the stop cotrimoxazole arm (upper 95% confidence limit of stop:continue hazard ratio 1.6).|Hazard Ratio (HR)|1.64||||0.007|TWO_SIDED|95.0|1.14|2.37|||Log Rank||Hazard ratio is stop vs continue.|"Assumptions~* 5% of children receiving daily cotrimoxazole prophylaxis have a new hospitalisation or death per year~* recruitment starts 1 July 2009 with 10% children (those already on ART for \>96 weeks) entering immediately, and then the remaining children recruited over the following 15 months as they reach 96 weeks on ART. Follow-up is until March 2012.~* cumulative loss to follow-up at March 2012 is 10%. See below for further details as box is not big enough"||2.37|1.14|0.007
71059818|NCT02028676|141626792|NON_INFERIORITY_OR_EQUIVALENCE|With assumptions above, at least 80% power and one-sided alpha=0.05, 947 children would be required in the stop/continue cotrimoxazole prophylaxis comparison to exclude an increase in hospitalisation/death rate of 3% from 5% to 8% per year in the stop cotrimoxazole arm (upper 95% confidence limit of stop:continue hazard ratio 1.6).|Risk Difference (RD)|4.0||||0.006|TWO_SIDED|95.0|0.8|7.2|||Poisson regression for risk difference||Risk difference is stop vs continue.|"Assumptions~* 5% of children receiving daily cotrimoxazole prophylaxis have a new hospitalisation or death per year~* recruitment starts 1 July 2009 with 10% children (those already on ART for \>96 weeks) entering immediately, and then the remaining children recruited over the following 15 months as they reach 96 weeks on ART. Follow-up is until March 2012.~* cumulative loss to follow-up at March 2012 is 10%. See below for further details as box is not big enough."||7.2|0.8|0.006
71027744|NCT02275364|141562271|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|15.28|||<|0.0001|TWO_SIDED|95.0|12.32|18.25||Obtained from ANOVA model with Treatment and Period as fixed effects and subject as a random effect.|ANOVA||Adjusted Mean Difference is the treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.|||18.25|12.32|<0.0001
71027745|NCT02275364|141562272|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.93||||0.7366|TWO_SIDED|95.0|-6.43|4.57||Obtained from ANOVA with treatment, period and region of interest as fixed effects and subject as a random effect.|ANCOVA||Adjusted Mean Difference is the Treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.|||4.57|-6.43|0.7366
71027746|NCT02275364|141562273|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1533.74||||0.0004|TWO_SIDED|95.0|794.16|2273.32||Obtained from ANOVA model with Treatment and Period as fixed effects and subject as a random effect.|ANOVA||Adjusted Mean Difference is the Treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.|||2273.32|794.16|0.0004
71027747|NCT02275364|141562274|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.46||||0.7278|TWO_SIDED|95.0|-3.06|2.14||Obtained from ANOVA model with Treatment and Period as fixed effects and subject as a random effect.|ANOVA||Adjusted Mean Difference is the Treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.|||2.14|-3.06|0.7278
70852290|NCT02969655|141193132|NON_INFERIORITY|Non-inferiority was established if the lower limit of the 95% CI was greater than -1.0 g/dL. Even if the 95% CI for the difference was completely negative (i.e. lied fully within the range -1.0 to \<0 g/dL) non-inferiority was concluded on condition that the mean Hgb estimated in the daprodustat group was within the target range.|Mean Difference (Final Values)|0.06|||<|0.0001|TWO_SIDED|95.0|-0.11|0.23||The p value on this table is one-sided and calculated for the non-inferiority assessment.|Mixed model repeated measures (MMRM)||Analysis was performed by a MMRM with covariates of treatment, Baseline Hgb, visit, treatment-by-visit interaction, Baseline-by-visit interaction.|||0.23|-0.11|<.0001
70935975|NCT00070707|141372912|SUPERIORITY_OR_OTHER_LEGACY|||||||0.629|||||||ANOVA|||Baseline (AM)||||0.629
71109571|NCT02722408|141724366|OTHER|||||||0.9414||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.9414
71027748|NCT02275364|141562275|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|191.72||||0.1639|TWO_SIDED|95.0|-78.62|462.06||Obtained from ANOVA model with Treatment and Period as fixed effects and subject as a random effect.|ANCOVA||Adjusted Mean Difference is the Treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.|||462.06|-78.62|0.1639
71027749|NCT02275364|141562276|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.02||||0.4621|TWO_SIDED|95.0|-0.03|0.07||Obtained from ANOVA with treatment, period and region of interest as fixed effects and subject as a random effect.|ANOVA||Adjusted Mean Difference is the Treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.|||0.07|-0.03|0.4621
71027750|NCT03384745|141562337|SUPERIORITY|A sample size of 300 subjects has 99% power to detect a statistically significant difference between any treatment arm and placebo in the IGA score of 0 or 1 rate at Week 12, with a two-sided, unadjusted type I error of 0.05. Calculations assume IGA score 0 or 1 rates \>88% for study drug and \<=7% for placebo.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Null hypotheses were tested at Week 12 (individual M1095 treatment arms would not be different from placebo with respect to achievement of IGA scores of 0 or 1). The primary analysis was based on the intent-to-treat (ITT) population using a non-responder imputation (NRI) for missing values. Primary treatment comparisons versus placebo were made with the two-sided Cochran-Mantel-Haenszel (CMH) test stratified by actual prior biologic use (yes/no) and body weight (\<=90; \>90kg).|At Week 12, none (0.0% \[95% CI 0.0-6.8\]) of the 52 participants in the placebo group had an IGA score of 0 or 1 versus 25 (48.1% \[34.0-62.4\], p\<0.0001) of 52 participants in the M1095 30mg treatment group. Odds ratio could not be calculated due to the placebo group containing no responders.|||<0.0001
70935976|NCT00070707|141372912|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038|||||||ANOVA|||Change at Week 1 (AM)||||0.038
71109572|NCT02722408|141724366|OTHER|||||||0.9735||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.9735
70935977|NCT00070707|141372912|SUPERIORITY_OR_OTHER_LEGACY|||||||0.182|||||||ANOVA|||Change at Week 2 (AM)||||0.182
70935978|NCT00070707|141372912|SUPERIORITY_OR_OTHER_LEGACY|||||||0.149|||||||ANOVA|||Change at Week 3 (AM)||||0.149
71027751|NCT03384745|141562337|SUPERIORITY|A sample size of 300 subjects has 99% power to detect a statistically significant difference between any treatment arm and placebo in the IGA score of 0 or 1 rate at Week 12, with a two-sided, unadjusted type I error of 0.05. Calculations assume IGA score 0 or 1 rates \>88% for study drug and \<=7% for placebo.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Null hypotheses were tested at Week 12 (individual M1095 treatment arms would not be different from placebo with respect to achievement of IGA scores of 0 or 1). The primary analysis was based on the intent-to-treat (ITT) population using a non-responder imputation (NRI) for missing values. Primary treatment comparisons versus placebo were made with the two-sided Cochran-Mantel-Haenszel (CMH) test stratified by actual prior biologic use (yes/no) and body weight (\<=90; \>90kg).|At Week 12, none (0.0% \[95% CI 0.0-6.8\]) of the 52 participants in the placebo group had an IGA score of 0 or 1 versus 44 (84.6% \[71.9-93.1\], p\<0.0001) of 52 participants in the M1095 60mg treatment group. Odds ratio could not be calculated due to the placebo group containing no responders.|||<0.0001
71027752|NCT03384745|141562337|SUPERIORITY|A sample size of 300 subjects has 99% power to detect a statistically significant difference between any treatment arm and placebo in the IGA score of 0 or 1 rate at Week 12, with a two-sided, unadjusted type I error of 0.05. Calculations assume IGA score 0 or 1 rates \>88% for study drug and \<=7% for placebo.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Null hypotheses were tested at Week 12 (individual M1095 treatment arms would not be different from placebo with respect to achievement of IGA scores of 0 or 1). The primary analysis was based on the intent-to-treat (ITT) population using a non-responder imputation (NRI) for missing values. Primary treatment comparisons versus placebo were made with the two-sided Cochran-Mantel-Haenszel (CMH) test stratified by actual prior biologic use (yes/no) and body weight (\<=90; \>90kg).|At Week 12, none (0.0% \[95% CI 0.0-6.8\]) of the 52 participants in the placebo group had an IGA score of 0 or 1 versus 41 (77.4% \[63.8-87.7\], p\<0.0001) of 53 participants in the M1095 120mg normal load treatment group. Odds ratio could not be calculated due to the placebo group containing no responders.|||<0.0001
71027753|NCT03384745|141562337|SUPERIORITY|A sample size of 300 subjects has 99% power to detect a statistically significant difference between any treatment arm and placebo in the IGA score of 0 or 1 rate at Week 12, with a two-sided, unadjusted type I error of 0.05. Calculations assume IGA score 0 or 1 rates \>88% for study drug and \<=7% for placebo.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Null hypotheses were tested at Week 12 (individual M1095 treatment arms would not be different from placebo with respect to achievement of IGA scores of 0 or 1). The primary analysis was based on the intent-to-treat (ITT) population using a non-responder imputation (NRI) for missing values. Primary treatment comparisons versus placebo were made with the two-sided Cochran-Mantel-Haenszel (CMH) test stratified by actual prior biologic use (yes/no) and body weight (\<=90; \>90kg).|At Week 12, none (0.0% \[95% CI 0.0-6.8\]) of the 52 participants in the placebo group had an IGA score of 0 or 1 versus 45 (88.2% \[76.1-95.6\], p\<0.0001) of 51 participants in the M1095 120mg augmented load treatment group. Odds ratio could not be calculated due to the placebo group containing no responders.|||<0.0001
70852291|NCT02969655|141193133|SUPERIORITY||Odds Ratio (OR)|0.76||||0.7442|TWO_SIDED|95.0|0.34|1.71||The p value on this table is one-sided and calculated for the superiority assessment.|Regression, Logistic||Analysis was performed by logistic regression with covariates of treatment and Baseline Hgb.|||1.71|0.34|0.7442
70852292|NCT03060551|141193171|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.256||||||p value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.256
70935979|NCT00070707|141372912|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035|||||||ANOVA|||Change at Week 4 (AM)||||0.035
70935980|NCT00070707|141372912|SUPERIORITY_OR_OTHER_LEGACY|||||||0.056|||||||ANOVA|||Change at Final Week (AM)||||0.056
71027754|NCT03384745|141562337|SUPERIORITY|A sample size of 300 subjects has 99% power to detect a statistically significant difference between any treatment arm and placebo in the IGA score of 0 or 1 rate at Week 12, with a two-sided, unadjusted type I error of 0.05. Calculations assume IGA score 0 or 1 rates \>88% for study drug and \<=7% for placebo.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Null hypotheses were tested at Week 12 (individual M1095 treatment arms would not be different from placebo with respect to achievement of IGA scores of 0 or 1). The primary analysis was based on the intent-to-treat (ITT) population using a non-responder imputation (NRI) for missing values. Primary treatment comparisons versus placebo were made with the two-sided Cochran-Mantel-Haenszel (CMH) test stratified by actual prior biologic use (yes/no) and body weight (\<=90; \>90kg).|At Week 12, none (0.0% \[95% CI 0.0-6.8\]) of the 52 participants in the placebo group had an IGA score of 0 or 1 versus 41 (77.4% \[63.8-87.7\], p\<0.0001) of 53 participants in the secukinumab 300mg treatment group. Odds ratio could not be calculated due to the placebo group containing no responders.|||<0.0001
71027755|NCT02739984|141562353|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-64.14|STANDARD_ERROR_OF_MEAN|2.05|<|0.0001|TWO_SIDED|95.0|-68.16|-60.12|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-60.12|-68.16|<0.0001
71027756|NCT02739984|141562354|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-53.14|STANDARD_ERROR_OF_MEAN|2.25|<|0.0001|TWO_SIDED|95.0|-57.56|-48.71|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-48.71|-57.56|<0.0001
71027757|NCT02739984|141562355|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-67.2|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-72.1|-62.2|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-62.2|-72.1|<0.0001
71027758|NCT02739984|141562356|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-55.8|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|95.0|-61.0|-50.5|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-50.5|-61.0|<0.0001
71027759|NCT02739984|141562357|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-56.56|STANDARD_ERROR_OF_MEAN|1.89|<|0.0001|TWO_SIDED|95.0|-60.28|-52.85|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-52.85|-60.28|<0.0001
71027760|NCT02739984|141562358|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-46.28|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001|TWO_SIDED|95.0|-50.42|-42.15|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-42.15|-50.42|<0.0001
71027761|NCT02739984|141562359|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-52.48|STANDARD_ERROR_OF_MEAN|1.85|<|0.0001|TWO_SIDED|95.0|-56.1|-48.85|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-48.85|-56.10|<0.0001
71027762|NCT02739984|141562360|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-42.12|STANDARD_ERROR_OF_MEAN|2.04|<|0.0001|TWO_SIDED|95.0|-46.13|-38.11|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-38.11|-46.13|<0.0001
71027763|NCT02739984|141562361|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-41.06|STANDARD_ERROR_OF_MEAN|1.44|<|0.0001|TWO_SIDED|95.0|-43.9|-38.22|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-38.22|-43.90|<0.0001
71027764|NCT02739984|141562362|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-33.74|STANDARD_ERROR_OF_MEAN|1.59|<|0.0001|TWO_SIDED|95.0|-36.87|-30.6|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-30.60|-36.87|<0.0001
71027765|NCT02739984|141562363|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment Difference|77.9|||<|0.0001|TWO_SIDED|95.0|70.0|83.5|||Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Placebo|||83.5|70.0|<0.0001
70935981|NCT00070707|141372912|SUPERIORITY_OR_OTHER_LEGACY|||||||0.711|||||||ANOVA|||Baseline (PM)||||0.711
70935982|NCT00070707|141372912|SUPERIORITY_OR_OTHER_LEGACY|||||||0.098|||||||ANOVA|||Change at Week 1 (PM)||||0.098
70935983|NCT00070707|141372912|SUPERIORITY_OR_OTHER_LEGACY|||||||0.356|||||||ANOVA|||Change at Week 2 (PM)||||0.356
70935984|NCT00070707|141372912|SUPERIORITY_OR_OTHER_LEGACY|||||||0.529|||||||ANOVA|||Change at Week 3 (PM)||||0.529
70935985|NCT00070707|141372912|SUPERIORITY_OR_OTHER_LEGACY|||||||0.617|||||||ANOVA|||Change at Week 4 (PM)||||0.617
70935986|NCT00070707|141372912|SUPERIORITY_OR_OTHER_LEGACY|||||||0.422|||||||ANOVA|||Change at Final Week (PM)||||0.422
71027766|NCT02739984|141562364|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment Difference|69.1|||<|0.0001|TWO_SIDED|95.0|60.4|75.7|||Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Placebo|||75.7|60.4|<0.0001
71027767|NCT02739984|141562365|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment Difference|83.5|||<|0.0001|TWO_SIDED|95.0|77.7|87.4|||Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Placebo|||87.4|77.7|<0.0001
71027768|NCT02739984|141562366|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment Difference|64.7|||<|0.0001|TWO_SIDED|95.0|57.7|70.3|||Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Placebo|||70.3|57.7|<0.0001
71027769|NCT02739984|141562367|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-40.5|STANDARD_ERROR_OF_MEAN|3.87|<|0.0001|TWO_SIDED|95.0|-48.11|-32.9|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-32.90|-48.11|<0.0001
71027770|NCT02739984|141562368|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-32.56|STANDARD_ERROR_OF_MEAN|3.57|<|0.0001|TWO_SIDED|95.0|-39.58|-25.53|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-25.53|-39.58|<0.0001
70935987|NCT00070707|141372913|SUPERIORITY_OR_OTHER_LEGACY|Baseline||||||0.532|||||||Cochran-Mantel-Haenszel|||||||0.532
71059819|NCT02028676|141626793|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.33|TWO_SIDED|95.0|0.83|1.72|||Log Rank||Hazard ratio is stop vs continue.|||1.72|0.83|0.33
71059820|NCT02028676|141626794|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.45|TWO_SIDED|95.0|0.49|1.44|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.44|0.49|0.45
71059821|NCT02028676|141626794|SUPERIORITY_OR_OTHER|||||||0.43|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.43
70935988|NCT00070707|141372913|SUPERIORITY_OR_OTHER_LEGACY|Day 15||||||0.739|||||||Cochran-Mantel-Haenszel|||||||0.739
70935989|NCT00070707|141372913|SUPERIORITY_OR_OTHER_LEGACY|Day 29||||||0.227|||||||Cochran-Mantel-Haenszel|||||||0.227
70935990|NCT00070707|141372914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.104|||||||ANOVA|||Baseline (AM)||||0.104
70935991|NCT00070707|141372914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022|||||||ANOVA|||Change at Week 1 (AM)||||0.022
70935992|NCT00070707|141372914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|||||||ANOVA|||Change at Week 2 (AM)||||0.012
70935993|NCT00070707|141372914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANOVA|||Change at Week 3 (AM)||||0.001
70935994|NCT00070707|141372914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.033|||||||ANOVA|||Change at Week 4 (AM)||||0.033
70935995|NCT00070707|141372914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047|||||||ANOVA|||Change at Final Week (AM)||||0.047
71059822|NCT02028676|141626794|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.23|TWO_SIDED|95.0|0.33|1.31|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||1.31|0.33|0.23
70935996|NCT00070707|141372914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.269|||||||ANOVA|||Baseline (PM)||||0.269
70935997|NCT00070707|141372914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.308|||||||ANOVA|||Change at Week 1 (PM)||||0.308
70935998|NCT00070707|141372914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||ANOVA|||Change at Week 2 (PM)||||0.050
70935999|NCT00070707|141372914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014|||||||ANOVA|||Change at Week 3 (PM)||||0.014
70936000|NCT00070707|141372914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1|||||||ANOVA|||Change at Week 4 (PM)||||0.100
70936001|NCT00070707|141372914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.139|||||||ANOVA|||Change at Final Week (PM)||||0.139
70936002|NCT00070707|141372915|SUPERIORITY_OR_OTHER_LEGACY|||||||0.136|||||||ANOVA|||Baseline (AM)||||0.136
70936003|NCT00070707|141372915|SUPERIORITY_OR_OTHER_LEGACY|||||||0.126|||||||ANOVA|||Change at Week 1 (AM)||||0.126
70936004|NCT00070707|141372915|SUPERIORITY_OR_OTHER_LEGACY|||||||0.107|||||||ANOVA|||Change at Week 2 (AM)||||0.107
70936005|NCT00070707|141372915|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|||||||ANOVA|||Change at Week 3 (AM)||||0.006
70936006|NCT00070707|141372915|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||ANOVA|||Change at Week 4 (AM)||||0.030
70936007|NCT00070707|141372915|SUPERIORITY_OR_OTHER_LEGACY|||||||0.037|||||||ANOVA|||Change at Final Week (AM)||||0.037
70936008|NCT00070707|141372915|SUPERIORITY_OR_OTHER_LEGACY|||||||0.146|||||||ANOVA|||Baseline (PM)||||0.146
70936009|NCT00070707|141372915|SUPERIORITY_OR_OTHER_LEGACY|||||||0.426|||||||ANOVA|||Change at Week 1 (PM)||||0.426
70936010|NCT00070707|141372915|SUPERIORITY_OR_OTHER_LEGACY|||||||0.259|||||||ANOVA|||Change at Week 2 (PM)||||0.259
71027771|NCT02739984|141562369|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-19.25|STANDARD_ERROR_OF_MEAN|3.41|<|0.0001|TWO_SIDED|95.0|-25.95|-12.54|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-12.54|-25.95|<0.0001
71027772|NCT02739984|141562370|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-13.7|STANDARD_ERROR_OF_MEAN|4.02|<|0.0001|TWO_SIDED|95.0|-21.6|-5.8|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-5.80|-21.60|<0.0001
70936011|NCT00070707|141372915|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026|||||||ANOVA|||Change at Week 3 (PM)||||0.026
70936012|NCT00070707|141372915|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022|||||||ANOVA|||Change at Week 4 (PM)||||0.022
70936013|NCT00070707|141372915|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043|||||||ANOVA|||Change at Final Week (PM)||||0.043
70936014|NCT00070707|141372916|SUPERIORITY_OR_OTHER_LEGACY|||||||0.181|||||||ANOVA|||Baseline (AM)||||0.181
70936015|NCT00070707|141372916|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014|||||||ANOVA|||Change at Week 1 (AM)||||0.014
70936016|NCT00070707|141372916|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||ANOVA|||Change at Week 2 (AM)||||0.004
70936017|NCT00070707|141372916|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||ANOVA|||Change at Week 3 (AM)||||0.002
70936018|NCT00070707|141372916|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027|||||||ANOVA|||Change at Week 4 (AM)||||0.027
70936019|NCT00070707|141372916|SUPERIORITY_OR_OTHER_LEGACY|||||||0.069|||||||ANOVA|||Change at Final Week (AM)||||0.069
71027773|NCT02739984|141562371|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|9.8|STANDARD_ERROR_OF_MEAN|1.45|<|0.0001|TWO_SIDED|95.0|6.95|12.64|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||12.64|6.95|<0.0001
70936020|NCT00070707|141372916|SUPERIORITY_OR_OTHER_LEGACY|||||||0.373|||||||ANOVA|||Baseline (PM)||||0.373
70936021|NCT00070707|141372916|SUPERIORITY_OR_OTHER_LEGACY|||||||0.148|||||||ANOVA|||Change at Week 1 (PM)||||0.148
70936022|NCT00070707|141372916|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|||||||ANOVA|||Change at Week 2 (PM)||||0.009
70936023|NCT00070707|141372916|SUPERIORITY_OR_OTHER_LEGACY|||||||0.016|||||||ANOVA|||Change at Week 3 (PM)||||0.016
70936024|NCT00070707|141372916|SUPERIORITY_OR_OTHER_LEGACY|||||||0.113|||||||ANOVA|||Change at Week 4 (PM)||||0.113
70936025|NCT00070707|141372916|SUPERIORITY_OR_OTHER_LEGACY|||||||0.173|||||||ANOVA|||Change at Final Week (PM)||||0.173
71059823|NCT02028676|141626794|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.93|TWO_SIDED|95.0|0.52|1.81|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||1.81|0.52|0.93
71059824|NCT02028676|141626795|SUPERIORITY_OR_OTHER|||||||0.89|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.89
71059825|NCT02028676|141626795|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.64|TWO_SIDED|95.0|0.53|1.48|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||1.48|0.53|0.64
71059826|NCT02028676|141626795|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.71|TWO_SIDED|95.0|0.54|1.52|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||1.52|0.54|0.71
71059827|NCT02028676|141626796|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.73|1.38|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.38|0.73|0.98
71059828|NCT02028676|141626796|SUPERIORITY_OR_OTHER|||||||0.44|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.44
71059829|NCT02028676|141626796|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.3|TWO_SIDED|95.0|0.55|1.2|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||1.20|0.55|0.30
71059830|NCT02028676|141626796|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.24|TWO_SIDED|95.0|0.54|1.17|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||1.17|0.54|0.24
71059831|NCT02028676|141626797|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.52|TWO_SIDED|95.0|0.82|1.49|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM.|||1.49|0.82|0.52
71059832|NCT02028676|141626797|SUPERIORITY_OR_OTHER|||||||0.34||||||Global test with 2df, adjusted for randomization stratification factors|Log Rank|||||||0.34
71059833|NCT02028676|141626797|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.19|TWO_SIDED|95.0|0.54|1.13|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||1.13|0.54|0.19
71059834|NCT02028676|141626797|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.25|TWO_SIDED|95.0|0.56|1.16|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||1.16|0.56|0.25
71059835|NCT02028676|141626798|SUPERIORITY_OR_OTHER|||||||0.71|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.71
71059836|NCT02028676|141626798|SUPERIORITY_OR_OTHER|||||||0.58|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.58
71109573|NCT02722408|141724366|OTHER|||||||0.9825||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.9825
71059837|NCT02028676|141626799|SUPERIORITY_OR_OTHER|||||||0.07|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.07
71059838|NCT02028676|141626799|SUPERIORITY_OR_OTHER|||||||0.9|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.90
71109574|NCT02722408|141724366|OTHER|||||||0.442||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.4420
71059839|NCT02028676|141626800|SUPERIORITY_OR_OTHER|||||||0.64|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.64
71059840|NCT02028676|141626800|SUPERIORITY_OR_OTHER|||||||0.3|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.30
71059841|NCT02028676|141626801|SUPERIORITY_OR_OTHER|||||||0.45|||||||Regression, Linear|Adjusted for randomization stratification factors||||||0.45
71059842|NCT02028676|141626802|SUPERIORITY_OR_OTHER|||||||0.7|||||||Regression, Linear|Adjusted for randomization stratification factors||||||0.70
71059843|NCT02028676|141626803|SUPERIORITY_OR_OTHER|||||||0.59||0.0|||||Regression, Linear|Adjusted for randomization stratification factors||||||0.59
71059844|NCT02028676|141626803|SUPERIORITY_OR_OTHER|||||||0.01|||||||Regression, Linear|Global test with 2df, adjusted for randomization stratification factors||||||0.01
70936026|NCT00070707|141372917|SUPERIORITY_OR_OTHER_LEGACY|||||||0.089|||||||ANOVA|||Baseline (AM)||||0.089
71059845|NCT02028676|141626804|SUPERIORITY_OR_OTHER|||||||0.81|||||||Regression, Linear|Adjusted for randomization stratification factors||||||0.81
71059846|NCT02028676|141626804|SUPERIORITY_OR_OTHER|||||||0.03|||||||Regression, Linear|Global test with 2df, adjusted for randomization stratification factors||||||0.03
71059847|NCT02028676|141626805|SUPERIORITY_OR_OTHER|||||||0.86|||||||Chi-squared|||||||0.86
71059848|NCT02028676|141626805|SUPERIORITY_OR_OTHER|||||||0.02|||||||Chi-squared|||||||0.02
71059849|NCT02028676|141626806|SUPERIORITY_OR_OTHER|||||||0.2|||||||Chi-squared|||||||0.20
71059850|NCT02028676|141626806|SUPERIORITY_OR_OTHER|||||||0.002|||||||Chi-squared|||||||0.002
71059851|NCT02028676|141626807|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.22|TWO_SIDED|95.0|0.48|1.29|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.29|0.48|0.22
71059852|NCT02028676|141626808|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.672||||0.09|TWO_SIDED|95.0|0.42|1.075|||Log Rank||Hazard ratio is CDM vs LCM|||1.075|0.420|0.09
71059853|NCT02028676|141626808|SUPERIORITY_OR_OTHER|||||||0.04|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.04
71109575|NCT02722408|141724366|OTHER|||||||0.0378||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0378
71027774|NCT02739984|141562372|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|7.37|STANDARD_ERROR_OF_MEAN|1.62|<|0.0001|TWO_SIDED|95.0|4.19|10.56|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||10.56|4.19|<0.0001
71027775|NCT02739984|141562373|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-17.06|STANDARD_ERROR_OF_MEAN|2.98|<|0.0001|TWO_SIDED|95.0|-22.91|-11.21|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-11.21|-22.91|<0.0001
71027776|NCT02739984|141562374|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-13.33|STANDARD_ERROR_OF_MEAN|3.44|<|0.0001|TWO_SIDED|95.0|-20.09|-6.56|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-6.56|-20.09|<0.0001
71027777|NCT03008460|141562375|NON_INFERIORITY|Non-inferiority would be demonstrated if the lower limit of the 95% confidence interval of the adjusted treatment difference was higher than -15%.|Adjusted treatment difference|-7.61||||0.0907|TWO_SIDED|95.0|-18.45|3.24||P-value for non-inferiority was estimated from the adjusted treatment difference.|Regression, Logistic|||Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a logistic regression model, including treatment and country as covariates.||3.24|-18.45|0.0907
71027778|NCT03008460|141562376|OTHER||Adjusted treatment difference|-0.18||||0.0428|TWO_SIDED|95.0|-0.36|-0.01|||ANOVA|||Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates.||-0.01|-0.36|0.0428
71027779|NCT03008460|141562377|OTHER||Adjusted treatment difference|-0.07||||0.4676|TWO_SIDED|95.0|-0.25|0.12|||ANOVA|||"Left colon:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||0.12|-0.25|0.4676
71027780|NCT03008460|141562377|OTHER||Adjusted treatment difference|-0.09||||0.3076|TWO_SIDED|95.0|-0.25|0.08|||ANOVA|||"Transverse colon:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||0.08|-0.25|0.3076
71027781|NCT03008460|141562377|OTHER||Adjusted treatment difference|-0.24||||0.0155|TWO_SIDED|95.0|-0.44|-0.05|||ANOVA|||"Right colon:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||-0.05|-0.44|0.0155
70936027|NCT00070707|141372917|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014|||||||ANOVA|||Change at Week 1 (AM)||||0.014
71027782|NCT03008460|141562377|OTHER||Adjusted treatment difference|-0.36||||0.0975|TWO_SIDED|95.0|-0.79|0.07|||ANOVA|||"Global score:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||0.07|-0.79|0.0975
71027783|NCT03008460|141562378|OTHER||Adjusted treatment difference rate|1.3847||||0.2428|TWO_SIDED|95.0|0.8|2.4|||CMH chi-square|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) chi-square method (using the general association statistic), stratified on country.||2.4|0.8|0.2428
71027784|NCT03008460|141562379|OTHER||Adjusted treatment difference rate|24.0219|||<|0.0001|TWO_SIDED|95.0|12.6|45.9|||CMH chi-square|||Analysis was performed using CMH chi-square method (using the general association statistic), stratified on country.||45.9|12.6|<0.0001
71027785|NCT03008460|141562380|OTHER||Adjusted treatment difference rate|1.0022||||0.9257|TWO_SIDED|95.0|1.0|1.1|||CMH chi-square|||Analysis was performed using CMH chi-square method (using the general association statistic), stratified on country.||1.1|1.0|0.9257
71027786|NCT03008460|141562382|OTHER||Adjusted treatment difference|-0.93||||0.4459|TWO_SIDED|95.0|-3.32|1.47|||ANOVA|||Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates.||1.47|-3.32|0.4459
71027787|NCT03008460|141562383|OTHER||Adjusted treatment difference|0.71|||<|0.0001|TWO_SIDED|95.0|0.4|1.03|||ANOVA|||Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates.||1.03|0.40|<0.0001
71027788|NCT03008460|141562384|OTHER||Adjusted treatment difference rate|1.22||||0.3945|TWO_SIDED|95.0|-1.6|4.05|||ANOVA|||"Dose 1:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||4.05|-1.60|0.3945
71059854|NCT02028676|141626808|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.16||||0.017|TWO_SIDED|95.0|1.15|4.08|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||4.08|1.15|0.017
70936028|NCT00070707|141372917|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||ANOVA|||Change at Week 2 (AM)||||0.004
70936029|NCT00070707|141372917|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANOVA|||Change at Week 3 (AM)||||0.001
70936030|NCT00070707|141372917|SUPERIORITY_OR_OTHER_LEGACY|||||||0.041|||||||ANOVA|||Change at Week 4 (AM)||||0.041
70936031|NCT00070707|141372917|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036|||||||ANOVA|||Change at Final Week (AM)||||0.036
70936032|NCT00070707|141372917|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17|||||||ANOVA|||Baseline (PM)||||0.170
71027789|NCT03008460|141562384|OTHER||Adjusted treatment difference rate|6.38||||0.0085|TWO_SIDED|95.0|1.65|11.12|||ANOVA|||"Dose 2:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||11.12|1.65|0.0085
71027790|NCT03008460|141562384|OTHER||Adjusted treatment difference rate|7.48||||0.0036|TWO_SIDED|95.0|2.46|12.5|||ANOVA|||"Global:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||12.50|2.46|0.0036
71027791|NCT03008460|141562387|OTHER||Adjusted treatment difference|1.05||||0.0015|TWO_SIDED|95.0|0.41|1.69|||ANOVA|||Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using 2-way ANOVA, including treatment and country as covariates.||1.69|0.41|0.0015
71027792|NCT04947579|141562394|SUPERIORITY||Stratified difference|2.4||||0.829|TWO_SIDED|95.0|-18.2|22.7|||Cochran-Mantel-Haenszel||CC99677 60 mg - Placebo|||22.7|-18.2|0.829
71027793|NCT04947579|141562394|SUPERIORITY||Stratified difference|7.3||||0.512|TWO_SIDED|95.0|-13.8|27.5|||Cochran-Mantel-Haenszel||CC99677 150 mg - Placebo|||27.5|-13.8|0.512
71027794|NCT04947579|141562395|SUPERIORITY||Stratified difference|3.3||||0.725|TWO_SIDED|95.0|-14.9|21.0|||Cochran-Mantel-Haenszel||CC99677 60 mg - Placebo|||21.0|-14.9|0.725
71027795|NCT04947579|141562395|SUPERIORITY||Stratfied difference|12.2||||0.219|TWO_SIDED|95.0|-7.2|30.5|||Cochran-Mantel-Haenszel||CC99677 150 mg - Placebo|||30.5|-7.2|0.219
71027796|NCT04947579|141562396|SUPERIORITY||Difference in Adjusted Means|-0.17|STANDARD_ERROR_OF_MEAN|0.167||0.299|TWO_SIDED|95.0|-0.5|0.16|||Longitudinal data analysis model||CC99677 60 mg - Placebo|||0.16|-0.50|0.299
71027797|NCT04947579|141562396|SUPERIORITY||Difference in Adjusted Means|-0.12|STANDARD_ERROR_OF_MEAN|0.168||0.488|TWO_SIDED|95.0|-0.45|0.22|||Longitudinal data analysis model||CC99677 150 mg - Placebo|||0.22|-0.45|0.488
71027798|NCT04947579|141562397|SUPERIORITY||Difference in Adjusted Means|0.01|STANDARD_ERROR_OF_MEAN|0.391||0.97|TWO_SIDED|95.0|-0.76|0.79|||Longitudinal data analysis model||CC99677 60 mg - Placebo|||0.79|-0.76|0.970
71027799|NCT04947579|141562397|SUPERIORITY||Difference in Adjusted Means|-0.17|STANDARD_ERROR_OF_MEAN|0.393||0.668|TWO_SIDED|95.0|-0.95|0.61|||Longitudinal data analysis model||CC99677 150 mg - Placebo|||0.61|-0.95|0.668
71027800|NCT04947579|141562398|SUPERIORITY||Difference in Adjusted Means|0.06|STANDARD_ERROR_OF_MEAN|0.416||0.89|TWO_SIDED|95.0|-0.77|0.88|||Longitudinal data analysis model||CC99677 60 mg - Placebo|||0.88|-0.77|0.890
71027801|NCT04947579|141562398|SUPERIORITY||Difference in Adjusted Means|0.25|STANDARD_ERROR_OF_MEAN|0.417||0.545|TWO_SIDED|95.0|-0.57|1.08|||Longitudinal data analysis model||CC99677 150 mg - Placebo|||1.08|-0.57|0.545
71027802|NCT04947579|141562399|SUPERIORITY||Difference in Adjusted Means|-0.28|STANDARD_ERROR_OF_MEAN|0.999||0.778|TWO_SIDED|95.0|-2.26|1.7|||Longitudinal data analysis model||CC99677 60 mg - Placebo|||1.70|-2.26|0.778
71027803|NCT04947579|141562399|SUPERIORITY||Difference in Adjusted Means|-1.0|STANDARD_ERROR_OF_MEAN|1.022||0.33|TWO_SIDED|95.0|-3.02|1.03|||Longitudinal data analysis model||CC99677 150 mg - Placebo|||1.03|-3.02|0.330
71027804|NCT04947579|141562400|SUPERIORITY||Difference in Adjusted Means|-0.82|STANDARD_ERROR_OF_MEAN|1.567||0.6|TWO_SIDED|95.0|-3.93|2.28|||Longitudinal data analysis model||CC99677 60 mg - Placebo|||2.28|-3.93|0.600
71027805|NCT04947579|141562400|SUPERIORITY||Difference in Adjusted Means|-1.31|STANDARD_ERROR_OF_MEAN|1.605||0.416|TWO_SIDED|95.0|-4.49|1.87|||Longitudinal data analysis model||CC99677 150 mg - Placebo|||1.87|-4.49|0.416
71027806|NCT04947579|141562401|SUPERIORITY||Adjusted Mean|-6.26|STANDARD_ERROR_OF_MEAN|10.741||||95.0|-27.31|14.79||||||||14.79|-27.31|
71027807|NCT04947579|141562401|SUPERIORITY||Adjusted Mean|-18.58|STANDARD_ERROR_OF_MEAN|9.181|||TWO_SIDED|95.0|-36.57|-0.58||||||||-0.58|-36.57|
71027808|NCT04947579|141562401|SUPERIORITY||Adjusted Mean|-12.16|STANDARD_ERROR_OF_MEAN|10.105|||TWO_SIDED|95.0|-31.96|7.65||||||||7.65|-31.96|
71027809|NCT01566409|141562407|NON_INFERIORITY_OR_EQUIVALENCE|The required sample size was based on a projected treatment success in the PEG group of 60%. With a power in excess of 80% and a critical level of significance of 0.05, 45 children were needed in each group to detect a 50% reduction in treatment effect in the placebo group, corresponding to 30% recovers without active maintenance treatment. Because of an expected drop-out rate of 25%, we aimed at including 115 children.||||||0.024|||||||Regression, Logistic|||||||0.024
71027810|NCT00097695|141562431|SUPERIORITY_OR_OTHER_LEGACY|||||||0.142||95.0|||||Wilcoxon version of the log-rank test|The Wilcoxon version of the log-rank test of SAS was used to calculate statistical significance between p- vs icatibant group and placebo group.||||||0.142
71027811|NCT00097695|141562432|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Wilcoxon version of the log-rank test|The median time to onset is calculated using Kaplan-Meier methodology. The Wilcoxon version of the log-rank test of SAS is used.||||||< 0.001
71027812|NCT00097695|141562433|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.079||95.0|||||Wilcoxon version of the log-rank test|The median time to almost complete symptom relief was calculated using Kaplan-Meier methodology.The Wilcoxon version of the log-rank test of SAS used.||||||= 0.079
71027813|NCT01691508|141562488|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39||||0.008|TWO_SIDED|95.0|1.25|4.56|||Proportional odds model|||||4.56|1.25|0.008
71027814|NCT02207231|141562497|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||<0.001
71027815|NCT02207231|141562498|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||<0.001
71027816|NCT02207231|141562499|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 24||||< 0.001
71027817|NCT02207231|141562499|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 48||||< 0.001
71027818|NCT02207231|141562500|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 24||||< 0.001
71027819|NCT02207231|141562500|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 48||||< 0.001
71027820|NCT02207231|141562501|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 24||||< 0.001
71027821|NCT02207231|141562501|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 48||||< 0.001
71027822|NCT02207231|141562502|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||p value is based on analysis of variance (ANOVA) model stratified by investigator site (pooled).||||< 0.001
71027823|NCT02207231|141562503|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= 10.0%|Difference in Percentage|19.3|||<|0.001|TWO_SIDED|95.0|12.9|25.7|||MH Z-test|||p value is based on 1-sided Mantel Haenszel (MH) Z-test adjusted for investigator site (pooled).||25.7|12.9|< 0.001
71027824|NCT02207231|141562503|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
71027825|NCT02207231|141562504|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= 10.0%|Difference in Percentage|24.1|||<|0.001|TWO_SIDED|95.0|17.0|31.0|||MH Z-test|||p value is based on 1-sided MH Z-test adjusted for investigator site (pooled).||31.0|17.0|< 0.001
71027826|NCT02207231|141562504|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
70936033|NCT00070707|141372917|SUPERIORITY_OR_OTHER_LEGACY|||||||0.237|||||||ANOVA|||Change at Week 1 (PM)||||0.237
71059855|NCT02028676|141626808|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.0||||0.034|TWO_SIDED|95.0|1.05|3.8|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||3.80|1.05|0.034
71059856|NCT02028676|141626809|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.04|TWO_SIDED|95.0|1.02|1.66|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.66|1.02|0.04
71059857|NCT02028676|141626809|SUPERIORITY_OR_OTHER|||||||0.53|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.53
71059858|NCT02028676|141626809|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.6|TWO_SIDED|95.0|0.68|1.25|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||1.25|0.68|0.60
71059859|NCT02028676|141626809|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.56|TWO_SIDED|95.0|0.81|1.46|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||1.46|0.81|0.56
71059860|NCT02028676|141626810|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.84|TWO_SIDED|95.0|0.58|1.56|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.56|0.58|0.84
71059861|NCT02028676|141626810|SUPERIORITY_OR_OTHER|||||||0.002|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.002
71059862|NCT02028676|141626810|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.8||||0.001|TWO_SIDED|95.0|1.74|8.29|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||8.29|1.74|0.001
71059863|NCT02028676|141626810|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.09||||0.006|TWO_SIDED|95.0|1.39|6.85|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||6.85|1.39|0.006
70936034|NCT00070707|141372917|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019|||||||ANOVA|||Change at Week 2 (PM)||||0.019
70936035|NCT00070707|141372917|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||ANOVA|||Change at Week 3 (PM)||||0.018
70936036|NCT00070707|141372917|SUPERIORITY_OR_OTHER_LEGACY|||||||0.149|||||||ANOVA|||Change at Week 4 (PM)||||0.149
71027827|NCT02207231|141562505|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= 10%|Difference in percentage|18.0|||<|0.001|TWO_SIDED|95.0|12.4|23.8|||MH Z-test|||p value is based on 1-sided MH Z-test adjusted for investigator site (pooled).||23.8|12.4|< 0.001
71027828|NCT02207231|141562505|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
71027829|NCT02207231|141562506|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
71027830|NCT02207231|141562507|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||p value is based on ANOVA model stratified by investigator site (pooled).||||< 0.001
71027831|NCT02207231|141562508|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
71027832|NCT02016300|141562551|OTHER|||||||0.162|||||||Regression, Linear|||Difference between baseline and month 6.||||0.162
71027833|NCT02016300|141562551|OTHER|||||||0.094|||||||Regression, Linear|||Difference between baseline and month 12.||||0.094
71027834|NCT02016300|141562551|OTHER|||||||0.043|||||||Regression, Linear|||Difference between baseline and month 24.||||0.043
71027835|NCT02016300|141562552|OTHER|||||||0.387|||||||Regression, Linear|||Difference between baseline and month 6.||||0.387
71027836|NCT02016300|141562552|OTHER|||||||0.34|||||||Regression, Linear|||Difference between baseline and month 12.||||0.340
71027837|NCT02016300|141562552|OTHER|||||||0.179|||||||Regression, Linear|||Difference between baseline and month 24.||||0.179
71059864|NCT02028676|141626811|SUPERIORITY_OR_OTHER|||||||0.53|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.53
71059865|NCT02028676|141626811|SUPERIORITY_OR_OTHER|||||||0.46|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.46
71059866|NCT02028676|141626812|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.3||||0.52|TWO_SIDED|95.0|-9.3|4.7|||Chi-squared|||||4.7|-9.3|0.52
71027838|NCT02016300|141562553|OTHER|||||||0.729|||||||Regression, Linear|||Difference between baseline and month 6.||||0.729
71027839|NCT02016300|141562553|OTHER|||||||0.958|||||||Regression, Linear|||Difference between baseline and month 12.||||0.958
71027840|NCT02016300|141562553|OTHER|||||||0.634|||||||Regression, Linear|||Difference between baseline and month 24.||||0.634
71027841|NCT02016300|141562554|OTHER|||||||0.733|||||||Regression, Linear|||Difference between baseline and month 6.||||0.733
71027842|NCT02016300|141562554|OTHER|||||||0.666|||||||Regression, Linear|||Difference between baseline and month 12.||||0.666
71027843|NCT02016300|141562554|OTHER|||||||0.854|||||||Regression, Linear|||Difference between baseline and month 24.||||0.854
71027844|NCT02016300|141562555|OTHER|||||||0.774|||||||Regression, Linear|||Difference between baseline and month 12.||||0.774
71027845|NCT02016300|141562555|OTHER|||||||0.414|||||||Regression, Linear|||Difference between baseline and month 24.||||0.414
71027846|NCT02016300|141562556|OTHER|||||||0.064|||||||Regression, Linear|||Difference between baseline and month 12.||||0.064
71027847|NCT02016300|141562556|OTHER|||||||0.276|||||||Regression, Linear|||Difference between baseline and month 24.||||0.276
71027848|NCT02016300|141562557|OTHER|||||||0.02|||||||Regression, Linear|||Difference between baseline and month 12.||||0.020
71027849|NCT02016300|141562557|OTHER|||||||0.091|||||||Regression, Linear|||Difference between baseline and month 24.||||0.091
71027850|NCT03238677|141562599|SUPERIORITY||Mean Difference (Final Values)|-10.0||||0.132|TWO_SIDED|95.0|-23.2|3.1|||Mixed Models Analysis|||Main effect of biofeedback at 10 weeks||3.1|-23.2|.132
71027851|NCT03238677|141562599|SUPERIORITY||Mean Difference (Final Values)|-13.7||||0.028|TWO_SIDED|95.0|-25.9|-1.5|||Mixed Models Analysis|||Main effect of Practice Distribution at 10 weeks||-1.5|-25.9|.028
71027852|NCT03238677|141562599|SUPERIORITY||Mean Difference (Final Values)|-10.0||||0.187|TWO_SIDED|95.0|-24.9|5.0|||Mixed Models Analysis|||Main effect comparing telepractice vs face-to-face treatment||5.0|-24.9|.187
71027853|NCT03238677|141562599|SUPERIORITY||Mean Difference (Final Values)|20.22||||0.125|TWO_SIDED|95.0|-5.8|46.3|||Mixed Models Analysis|||Interaction of biofeedback and practice distribution at 10 weeks|η2 =.054|46.3|-5.8|.125
71027854|NCT02433665|141562604|NON_INFERIORITY|The primary end point for this study was a comparison between fixed-dose and customized-dose contrast material injection CT protocols for vascular and parenchymal enhancement by using a noninferiority approach. The limit of noninferiority was set at 0.1 before the initiation of the study on the basis of a similar study that examined contrast media dose optimization for CT angiography examinations.|Odds Ratio, log|0.75|STANDARD_DEVIATION|0.35|>|0.05|TWO_SIDED|0.38|||||Mixed Models Analysis|||||||>0.05
71027855|NCT00757601|141562606|NON_INFERIORITY_OR_EQUIVALENCE|"To assess the effect of food at the 30 mg dose, a point estimate was constructed for the geometric mean ratio for the fed/fasted states (GMR\[fed/fasted\]) of MK1006 AUC (0-∞).~The GMR (fed/fasted) was calculated using the geometric mean AUC (0-∞) of the fed state divided by the geometric mean AUC (0-∞) fasted state.~A GMR (fed/fasted) point estimate value within 20% of unity (1.00) was considered consistent with an absence of a clinically significant food effect."|Geometric Mean Ratio (fed/fasted)|1.03||||||95.0|||||Mixed-Effect Model|||A linear mixed-effect model was used to estimate the geometric mean AUC (0-∞) for MK1006 at every dose level.||||
71027856|NCT00757601|141562607|NON_INFERIORITY_OR_EQUIVALENCE|"To assess the effect of food at the 30 mg dose, a point estimate was constructed for the geometric mean ratio for the fed/fasted states (GMR\[fed/fasted\]) of MK1006 Cmax.~The GMR (fed/fasted) was calculated using the geometric mean Cmax of the fed state divided by the geometric mean Cmax fasted state.~A GMR (fed/fasted) point estimate value within 20% of unity (1.00) was considered consistent with an absence of a clinically significant food effect."|Geometric Mean Ratio (fed/fasted)|1.14||||||95.0|||||Mixed-effect Model|||A linear mixed-effect model was used to estimate the geometric mean Cmax for MK1006 at every dose level.||||
71027857|NCT01439165|141562621|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% Confidence Interval (CI) of the difference of seroprotection rates between groups is \> -10%|Difference (%) in Adacel-Td Adsorbed|0.0|||||TWO_SIDED|95.0|-0.4|1.2||||||Comparison of anti-tetanus seroprotection rate between the two groups||1.2|-0.4|
71059867|NCT02028676|141626813|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.39|TWO_SIDED|95.0|-1.2|0.5|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily|||0.5|-1.2|0.39
71027858|NCT01439165|141562621|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of seroprotection rates between groups is \> -10%|Difference (%) in Adacel-Td Adsorbed|0.42|||||TWO_SIDED|95.0|-0.3|2.1||||||Comparison of anti-diphtheria seroprotection rates between the two groups||2.1|-0.3|
71027859|NCT01439165|141562622|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is \> -10%|Difference (%) in Adacel-Td Adsorbed|-7.12|||||TWO_SIDED|95.0|-12.0|-1.7||||||Comparison of the anti-tetanus booster response rates between the two groups||-1.7|-12.0|
71027860|NCT01439165|141562622|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is \> -10%|Difference (%) in Adacel-Td Adsorbed|-0.95|||||TWO_SIDED|95.0|-5.4|4.0||||||Comparison of the anti-diphteria booster response rates between the two groups||4.0|-5.4|
71027861|NCT01439165|141562623|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the ratio of GMCs between groups is \> 0.66|GMC ratio (Adacel/Historical Control)|1.04|||||TWO_SIDED|95.0|0.92|1.18||||||Comparison of anti-pertussis toxoid GMCs between Adacel and historical control groups||1.18|0.92|
71027862|NCT01439165|141562623|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the ratio of GMCs between groups is \> 0.66|GMC Ratio (Adacel/Historical Control)|5.22|||||TWO_SIDED|95.0|4.51|6.05||||||Comparison of the anti-FHA GMCs between Adacel and historical Control groups||6.05|4.51|
70852293|NCT03060551|141193172|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.682||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.682
70852294|NCT03060551|141193173|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.151||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.151
71059868|NCT02028676|141626814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.98|TWO_SIDED|95.0|-0.9|0.9|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily|||0.9|-0.9|0.98
71059869|NCT02028676|141626815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.12|TWO_SIDED|95.0|-1.9|0.2|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily|||0.2|-1.9|0.12
70936037|NCT00070707|141372917|SUPERIORITY_OR_OTHER_LEGACY|||||||0.231|||||||ANOVA|||Change at Final Week (PM)||||0.231
71027863|NCT01439165|141562623|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the ratio of GMCs between groups is \> 0.66|GMC Ratio (Adacel/Historical Control)|2.94|||||TWO_SIDED|95.0|2.46|3.51||||||Comparison of the anti-Pertactin GMCs between Adacel and historical Control groups||3.51|2.46|
71027864|NCT01439165|141562623|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the ratio of GMCs between groups is \> 0.66|GMC Ratio (Adacel/Historical Control)|2.18|||||TWO_SIDED|95.0|1.84|2.6||||||Comparison of the post-vaccination anti-Fimbriae (types 2 and 3) GMCs between Adacel and historical Control groups||2.60|1.84|
71059870|NCT02028676|141626816|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.0||||0.82|TWO_SIDED|95.0|-60.0|76.0|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily|||76|-60|0.82
71059871|NCT02028676|141626817|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-33.0||||0.36|TWO_SIDED|95.0|-104.0|38.0|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily|||38|-104|0.36
70936038|NCT00070707|141372918|SUPERIORITY_OR_OTHER_LEGACY|||||||0.745|||||||ANOVA|||Baseline (AM)||||0.745
71027865|NCT01439165|141562624|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is \> -10% .|Difference (%) Adacel-Expected Booster|16.12|||||TWO_SIDED|95.0|13.27|18.73||||||comparison of anti-pertussis toxoid booster response rates was performed between the Adacel and historical groups||18.73|13.27|
71027866|NCT01439165|141562624|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is \> -10%|Difference (%) Adacel-Expected Booster|-4.21|||||TWO_SIDED|95.0|-7.23|-1.34||||||Comparison of the anti-FHA booster response rates between the Adacel and historical groups||-1.34|-7.23|
71027867|NCT01439165|141562624|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is \> -10% .|Difference (%) Adacel-Expected Booster|-18.61|||||TWO_SIDED|95.0|-21.7|-15.6||||||Comparison of the anti-Pertactin booster response rates between Adacel and historical groups||-15.6|-21.7|
70936039|NCT00070707|141372918|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|||||||ANOVA|||Change at Week 1 (AM)||||0.250
71027868|NCT01439165|141562624|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is \> -10% .|Difference (%) Adacel-Expected Booster|-19.07|||||TWO_SIDED|95.0|-22.3|-16.0||||||Comparison of the anti-Fimbriae (types 2 and 3) booster response rates between Adacel and historical groups||-16.0|-22.3|
71027869|NCT00442936|141562649|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.26|||<|0.001|TWO_SIDED|95.0|1.4|3.66|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.66|1.40|<0.001
71027870|NCT00442936|141562649|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.81|||<|0.001|TWO_SIDED|95.0|2.42|6.0|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||6.00|2.42|<0.001
71027871|NCT00442936|141562650|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.82|||<|0.001|TWO_SIDED|95.0|2.02|3.95|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.95|2.02|<0.001
71027872|NCT00442936|141562650|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.44|||<|0.001|TWO_SIDED|95.0|2.47|4.79|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.79|2.47|<0.001
71027873|NCT00442936|141562651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.14|||<|0.001|TWO_SIDED|95.0|1.54|2.97|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.97|1.54|<0.001
71027874|NCT00442936|141562651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.61|||<|0.001|TWO_SIDED|95.0|1.89|3.61|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.61|1.89|<0.001
71027875|NCT00442936|141562652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05|||<|0.001|TWO_SIDED|95.0|1.49|2.82|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.82|1.49|<0.001
71027876|NCT00442936|141562652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.37|||<|0.001|TWO_SIDED|95.0|1.73|3.25|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.25|1.73|<0.001
71109576|NCT02722408|141724366|OTHER|||||||0.0378||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0378
71027877|NCT00442936|141562653|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73|||<|0.001|TWO_SIDED|95.0|1.25|2.39|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.39|1.25|<0.001
71027878|NCT00442936|141562653|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.006|TWO_SIDED|95.0|1.13|2.13|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.13|1.13|0.006
71059872|NCT02028676|141626818|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-87.0||||0.2|TWO_SIDED|95.0|-220.0|46.0|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily|||46|-220|0.20
71059873|NCT02028676|141626820|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43||||0.2|TWO_SIDED|95.0|0.11|1.64|||Log Rank||Hazard ratio is once-daily vs twice-daily|||1.64|0.11|0.20
71059874|NCT02028676|141626821|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.51|TWO_SIDED|95.0|0.31|1.77|||Log Rank||Hazard ratio is once-daily vs twice-daily|||1.77|0.31|0.51
71109577|NCT02722408|141724367|OTHER|||||||0.2305||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.2305
71109578|NCT02722408|141724367|OTHER|||||||0.1836||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.1836
71109579|NCT02722408|141724367|OTHER|||||||0.6501||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.6501
70936040|NCT00070707|141372918|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 2 (AM)||||||0.202|||||||ANOVA|||||||0.202
70936041|NCT00070707|141372918|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 3 (AM)||||||0.104|||||||ANOVA|||||||0.104
71059875|NCT02028676|141626822|SUPERIORITY_OR_OTHER|||||||0.16|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.16
71109580|NCT02722408|141724367|OTHER|||||||0.0139||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.0139
71109581|NCT02722408|141724367|OTHER|||||||0.0077||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.0077
71027879|NCT00442936|141562654|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.8||||0.002|TWO_SIDED|95.0|1.47|5.35|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||5.35|1.47|0.002
71027880|NCT00442936|141562654|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.75|||<|0.001|TWO_SIDED|95.0|3.15|10.51|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||10.51|3.15|<0.001
71027881|NCT00442936|141562655|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.78||||0.026|TWO_SIDED|95.0|1.07|2.97|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.97|1.07|0.026
71027882|NCT00442936|141562655|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.34|||<|0.001|TWO_SIDED|95.0|2.08|5.35|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||5.35|2.08|<0.001
71027883|NCT00442936|141562656|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.25||||0.021|TWO_SIDED|95.0|1.13|4.47|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.47|1.13|0.021
71027884|NCT00442936|141562656|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.21|||<|0.001|TWO_SIDED|95.0|2.78|9.76|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||9.76|2.78|<0.001
71059876|NCT02028676|141626823|SUPERIORITY_OR_OTHER|||||||0.54|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.54
71027885|NCT01024738|141562677|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71027886|NCT01700621|141562689|NON_INFERIORITY|A noninferiority margin of -10% was chosen as the maximal absolute reduction in proportion seroprotection allowed in the concomitant measles-rubella and rotavirus vaccine group as compared to the measles-rubella vaccine alone group.|Seroconversion proportion difference|1.1|||||TWO_SIDED|95.0|-6.9|9.0||||||||9.0|-6.9|
71027887|NCT00625807|141562781|OTHER||||||>|0.1||||||Cohen's d = 0.5|ANOVA|||ANOVA for group by time interaction||||> 0.1
71027888|NCT00625807|141562782|OTHER|||||||0.103|||||||ANOVA|||||||0.103
71027889|NCT00625807|141562783|OTHER|||||||0.022|||||||t-test, 2 sided|||within group change pre to week 8||||.022
71027890|NCT00625807|141562783|OTHER|within group change from pre to week 8|||||<|0.001|||||||t-test, 2 sided|||||||<.001
71027891|NCT00625807|141562784|OTHER|||||||0.015|||||||t-test, 2 sided|||within group change from pre to week 8||||.015
71027892|NCT00625807|141562784|OTHER|||||||0.53|||||||t-test, 2 sided|||within group change from pre to week 8||||.53
71027893|NCT00625807|141562785|OTHER|||||||0.06|||||||t-test, 2 sided|||within group change from pre to week 8||||.06
71027894|NCT00625807|141562785|OTHER||||||<|0.001|||||||t-test, 2 sided|||within group change from pre to post||||<.001
71027895|NCT00918567|141562851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.22|STANDARD_ERROR_OF_MEAN|1.93|<|0.05|TWO_SIDED|||||Also tested marginal effects defined as p \< .10.|Mixed Models Analysis|Tukey-Kramer adjustments for post-hoc differences of least squares comparisons||||||<.05
71027896|NCT00918567|141562852|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.51|<|0.05|TWO_SIDED|||||Also examined marginal effects, defined as p\<.10|Mixed Models Analysis|||||||<.05
71027897|NCT00918567|141562853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.6|<|0.05|TWO_SIDED|||||Also tested marginal effects defined as p\<.10|Mixed Models Analysis|||||||<.05
71027898|NCT00918567|141562854|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.09|<|0.05|TWO_SIDED|||||Also estimated marginal effects defined as p\<.10|Mixed Models Analysis|||||||<.05
71027899|NCT00918567|141562855|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.07|<|0.05|TWO_SIDED|||||also tested marginal effects defined as p\<.10|Mixed Models Analysis|||||||<.05
71027900|NCT00918567|141562856|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.18|>|0.05|TWO_SIDED|||||Also tested marginal effects defined as p\<.10|Mixed Models Analysis|||||||>.05
71027901|NCT00918567|141562857|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.2|<|0.05|TWO_SIDED|||||Also tested marginal effects (p\<.10)|Mixed Models Analysis|||||||<.05
71027902|NCT00918567|141562858|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.05|STANDARD_ERROR_OF_MEAN|1.7|<|0.05|TWO_SIDED|||||Also tested marginal effects (p\<.10)|Mixed Models Analysis|||||||<0.05
71027903|NCT00918567|141562859|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|1.8|<|0.05|TWO_SIDED|||||Also tested marginal effects (p\<.10)|Mixed Models Analysis|||||||<.05
71027904|NCT00918567|141562860|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.15|<|0.05|TWO_SIDED|||||Also tested marginal effect (p\<.10)|Mixed Models Analysis|||||||<.05
71027905|NCT00918567|141562861|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.19|<|0.05|TWO_SIDED|||||Also tested marginal effects (p\<.10)|Mixed Models Analysis|||||||<.05
71027906|NCT01055223|141562862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42|||||TWO_SIDED|95.0|1.13|1.78|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||1.78|1.13|
71027907|NCT01055223|141562862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.93|1.52|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||1.52|0.93|
71027908|NCT01055223|141562862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53|||||TWO_SIDED|95.0|0.78|2.98|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||2.98|0.78|
71027909|NCT01055223|141562862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46|||||TWO_SIDED|95.0|0.74|2.89|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||2.89|0.74|
70852295|NCT03060551|141193174|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.516||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.516
70852296|NCT03060551|141193175|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.|||||>|0.999||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||>0.999
70936042|NCT00070707|141372918|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 4 (AM)||||||0.348|||||||ANOVA|||||||0.348
70936043|NCT00070707|141372918|SUPERIORITY_OR_OTHER_LEGACY|Change at Final Week (AM)||||||0.355|||||||ANOVA|||||||0.355
71027910|NCT01055223|141562862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01|||||TWO_SIDED|95.0|0.18|22.14|||||Undadjusted Odds Ratio. Reference Group: TZD alone.|||22.14|0.18|
71027911|NCT01055223|141562862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|0.12|15.5|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||15.50|0.12|
71027912|NCT01055223|141562863|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41|||||TWO_SIDED|95.0|1.05|1.89|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||1.89|1.05|
71027913|NCT01055223|141562863|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.88|1.65|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||1.65|0.88|
71027914|NCT01055223|141562863|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58|||||TWO_SIDED|95.0|0.69|3.6|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||3.60|0.69|
71027915|NCT01055223|141562863|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63|||||TWO_SIDED|95.0|0.7|3.81|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||3.81|0.70|
71027916|NCT01055223|141562863|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone.|||0.00|0.00|
71027917|NCT01055223|141562863|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||0.00|0.00|
71027918|NCT01055223|141562864|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29|||||TWO_SIDED|95.0|0.92|1.79|||||Unadjusted Odds Ratio. Reference Group: TZD alone.|||1.79|0.92|
71027919|NCT01055223|141562864|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.71|1.45|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||1.45|0.71|
71027920|NCT01055223|141562864|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.44|||||TWO_SIDED|95.0|0.1|1.9|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||1.90|0.10|
71027921|NCT01055223|141562864|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.35|||||TWO_SIDED|95.0|0.08|1.54|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||1.54|0.08|
71027922|NCT01055223|141562864|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.99|||||TWO_SIDED|95.0|0.18|21.93|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||21.93|0.18|
71059877|NCT02028676|141626824|SUPERIORITY_OR_OTHER|||||||0.08|||||||Generalised estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.08
70936044|NCT00070707|141372918|SUPERIORITY_OR_OTHER_LEGACY|Baseline (PM)||||||0.851|||||||ANOVA|||||||0.851
71027923|NCT01055223|141562864|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.09|12.36|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||12.36|0.09|
71027924|NCT01055223|141562865|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|0.8|1.88|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||1.88|0.80|
71027925|NCT01055223|141562865|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.62|1.57|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||1.57|0.62|
71027926|NCT01055223|141562865|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone.|||0.00|0.00|
71027927|NCT01055223|141562865|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||0.00|0.00|
71027928|NCT01055223|141562865|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone.|||0.00|0.00|
71027929|NCT01055223|141562865|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates|||0.00|0.00|
71027930|NCT01055223|141562866|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.46|||||TWO_SIDED|95.0|1.53|19.45|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||19.45|1.53|
71027931|NCT01055223|141562866|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.19|||||TWO_SIDED|95.0|0.64|15.86|||||Unadjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||15.86|0.64|
71027932|NCT01055223|141562866|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone.|||0.00|0.00|
71027933|NCT01055223|141562866|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||0.00|0.00|
70936045|NCT00070707|141372918|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 1 (PM)||||||0.993|||||||ANOVA|||||||0.993
70936046|NCT00070707|141372918|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 2 (PM)||||||0.476|||||||ANOVA|||||||0.476
70936047|NCT00070707|141372918|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 3 (PM)||||||0.149|||||||ANOVA|||||||0.149
70936048|NCT00070707|141372918|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 4 (PM)||||||0.616|||||||ANOVA|||||||0.616
71027934|NCT01055223|141562866|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone.|||0.00|0.00|
71027935|NCT01055223|141562866|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||0.00|0.00|
71027936|NCT01055223|141562867|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.26|||||TWO_SIDED|95.0|0.66|80.35|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||80.35|0.66|
71027937|NCT01055223|141562867|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.78|||||TWO_SIDED|95.0|0.03|96.47|||||Adjusted Odds Ratio. Reference group: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosponates.|||96.47|0.03|
71027938|NCT01055223|141562867|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference Group: TZD alone.|||0.00|0.00|
71027939|NCT01055223|141562867|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||0.00|0.00|
70936049|NCT00070707|141372918|SUPERIORITY_OR_OTHER_LEGACY|Change at Final Week (PM)||||||0.527|||||||ANOVA|||||||0.527
71027940|NCT01055223|141562867|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone.|||0.00|0.00|
71027941|NCT01055223|141562867|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||0.00|0.00|
71027942|NCT03587207|141562868|OTHER|rMenBOMV+ACWY\_S is to be declared statistically inferior if the 2-sided 80% CIs of the between group ratio of the GMT with rMenBOMV+ACWY\_D as control is lower than 1 at 1 month after last vaccination. The following ANCOVA model is used: fixed-effect model including age strata, study group, strain and center as fixed effects. The pre vaccination (Baseline) log-transformed titer with centering at zero is included as a continuous covariate.|Geometric mean ratio|0.96|||||TWO_SIDED|80.0|0.83|1.1|||ANCOVA|An interaction between strain and pre-vaccination log transformed titer is included in the model to fit to the serogroup B test strain data only.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the pooled B strains, one month after last vaccination.||1.10|0.83|
71027943|NCT03587207|141562869|OTHER|M14459 strain-Between group ratios for comparison of rMenBOMV+ACWY\_S and rMenBOMV+ACWY\_D groups|Geometric mean ratio|1.0|||||TWO_SIDED|80.0|0.84|1.2|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B M14459 (fHbp) strain, one month after last vaccination.||1.20|0.84|
71059878|NCT02028676|141626825|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.82|TWO_SIDED|95.0|0.72|1.52|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is once-daily vs twice-daily|||1.52|0.72|0.82
71027944|NCT03587207|141562869|OTHER|96217 strain-Between group ratios for comparison of rMenBOMV+ACWY\_S and rMenBOMV+ACWY\_D groups|Geometric mean ratio|1.05||||||80.0|0.88|1.26|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B 96217 (NadA) strain, one month after last vaccination.||1.26|0.88|
71027945|NCT03587207|141562869|OTHER|NZ98/254 strain-Between group ratios for comparison of rMenBOMV+ACWY\_S and rMenBOMV+ACWY\_D groups|Geometric mean ratio|0.78|||||TWO_SIDED|80.0|0.64|0.95|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.||0.95|0.64|
71059879|NCT02028676|141626826|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.31|TWO_SIDED|95.0|0.48|1.27|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is once-daily vs twice-daily|||1.27|0.48|0.31
70936050|NCT00070707|141372919|SUPERIORITY_OR_OTHER_LEGACY|||||||0.116|||||||ANOVA|||Baseline (AM)||||0.116
70936051|NCT00070707|141372919|SUPERIORITY_OR_OTHER_LEGACY|||||||0.994|||||||ANOVA|||Change at Week 1 (AM)||||0.994
70936052|NCT00070707|141372919|SUPERIORITY_OR_OTHER_LEGACY|||||||0.961|||||||ANOVA|||Change at Week 2 (AM)||||0.961
70936053|NCT00070707|141372919|SUPERIORITY_OR_OTHER_LEGACY|||||||0.183|||||||ANOVA|||Change at Week 3 (AM)||||0.183
70936054|NCT00070707|141372919|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44|||||||ANOVA|||Change at Week 4 (AM)||||0.440
71059880|NCT02028676|141626827|SUPERIORITY_OR_OTHER|||||||0.74|||||||Chi-squared|||||||0.74
71059881|NCT02028676|141626828|SUPERIORITY_OR_OTHER|||||||0.9|||||||Chi-squared|||||||0.90
70936055|NCT00070707|141372919|SUPERIORITY_OR_OTHER_LEGACY|||||||0.838|||||||ANOVA|||Change at Final Week (AM)||||0.838
70936056|NCT00070707|141372919|SUPERIORITY_OR_OTHER_LEGACY|||||||0.096|||||||ANOVA|||Baseline (PM)||||0.096
71027946|NCT03587207|141562869|OTHER|M07-0241084 strain- Between group ratios for comparison of rMenBOMV\_ACWY\_S group and rMenBOMV+ACWY\_D group|Geometric mean ratio|0.8|||||TWO_SIDED|80.0|0.66|0.96|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.||0.96|0.66|
71027947|NCT03587207|141562869|OTHER|Serogroup A- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group|Geometric mean ratio|0.92|||||TWO_SIDED|80.0|0.74|1.14|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup A, one month after last vaccination.||1.14|0.74|
71027948|NCT03587207|141562869|OTHER|Serogroup C- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group|Geometric mean ratio|1.0|||||TWO_SIDED|80.0|0.78|1.27|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup C, one month after last vaccination.||1.27|0.78|
71027949|NCT03587207|141562869|OTHER|Serogroup W- Between group ratios for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group|Geometric mean ratio|0.97|||||TWO_SIDED|80.0|0.79|1.18|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup W, one month after last vaccination.||1.18|0.79|
71027950|NCT03587207|141562869|OTHER|Serogroup Y- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group|Geometric mean ratio|0.91|||||TWO_SIDED|80.0|0.69|1.19|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup Y, one month after last vaccination.||1.19|0.69|
71027951|NCT03587207|141562869|OTHER|M14459 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|1.02|||||TWO_SIDED|80.0|0.86|1.22|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B M14459 (fHbp) strain, one month after last vaccination.||1.22|0.86|
71027952|NCT03587207|141562869|OTHER|96217 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.79|||||TWO_SIDED|80.0|0.66|0.95|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B 96217 (NadA)strain, one month after last vaccination.||0.95|0.66|
71027953|NCT03587207|141562869|OTHER|NZ98/254 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.79|||||TWO_SIDED|80.0|0.65|0.97|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.||0.97|0.65|
71027954|NCT03587207|141562869|NON_INFERIORITY|M07-0241084 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.73|||||TWO_SIDED|80.0|0.6|0.88|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.||0.88|0.60|
70936057|NCT00070707|141372919|SUPERIORITY_OR_OTHER_LEGACY|||||||0.362|||||||ANOVA|||Change at Week 1 (PM)||||0.362
70936058|NCT00070707|141372919|SUPERIORITY_OR_OTHER_LEGACY|||||||0.693|||||||ANOVA|||Change at Week 2 (PM)||||0.693
70936059|NCT00070707|141372919|SUPERIORITY_OR_OTHER_LEGACY|||||||0.603|||||||ANOVA|||Change at Week 3 (PM)||||0.603
70936060|NCT00070707|141372919|SUPERIORITY_OR_OTHER_LEGACY|||||||0.579|||||||ANOVA|||Change at Week 4 (PM)||||0.579
70936061|NCT00070707|141372919|SUPERIORITY_OR_OTHER_LEGACY|||||||0.413|||||||ANOVA|||Change at Final Week (PM)||||0.413
70936062|NCT00070707|141372920|SUPERIORITY_OR_OTHER_LEGACY|||||||0.823|||||||ANOVA|||Baseline||||0.823
70936063|NCT00070707|141372920|SUPERIORITY_OR_OTHER_LEGACY|||||||0.744|||||||ANOVA|||Change at Day 15||||0.744
70936064|NCT00070707|141372920|SUPERIORITY_OR_OTHER_LEGACY|||||||0.675|||||||ANOVA|||Change at Day 29||||0.675
71027955|NCT03587207|141562869|OTHER|Serogroup A- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.56|||||TWO_SIDED|80.0|0.45|0.69|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogrpoup A, one month after last vaccination.||0.69|0.45|
70936065|NCT00070707|141372921|SUPERIORITY_OR_OTHER_LEGACY|||||||0.693|||||||ANOVA|||Baseline||||0.693
70936066|NCT00070707|141372921|SUPERIORITY_OR_OTHER_LEGACY|||||||0.818|||||||ANOVA|||Change at Day 15||||0.818
70936067|NCT00070707|141372921|SUPERIORITY_OR_OTHER_LEGACY|||||||0.915|||||||ANOVA|||Change at Day 29||||0.915
70936068|NCT00070707|141372922|SUPERIORITY_OR_OTHER_LEGACY|||||||0.823|||||||ANOVA|||Baseline||||0.823
70936069|NCT00070707|141372922|SUPERIORITY_OR_OTHER_LEGACY|||||||0.202|||||||ANOVA|||Change at Day 15||||0.202
70936070|NCT00070707|141372922|SUPERIORITY_OR_OTHER_LEGACY|||||||0.199|||||||ANOVA|||Change at Day 29||||0.199
70936071|NCT00070707|141372923|SUPERIORITY_OR_OTHER_LEGACY|||||||0.375|||||||ANOVA|||Baseline||||0.375
71109582|NCT02722408|141724367|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||<0.0001
70936072|NCT00070707|141372923|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71|||||||ANOVA|||Change at Week 1||||0.710
71109583|NCT02722408|141724367|OTHER|||||||0.0507||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0507
71109584|NCT02722408|141724367|OTHER|||||||0.0118||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.0118
71109585|NCT02722408|141724367|OTHER|||||||0.0122||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0122
71109586|NCT02722408|141724367|OTHER|||||||0.0077||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0077
71027956|NCT03587207|141562869|OTHER|Serogroup C- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|1.19|||||TWO_SIDED|80.0|0.94|1.52|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup C, one month after last vaccination.||1.52|0.94|
70936073|NCT00070707|141372923|SUPERIORITY_OR_OTHER_LEGACY|||||||0.597|||||||ANOVA|||Change at Week 2||||0.597
70936074|NCT00070707|141372923|SUPERIORITY_OR_OTHER_LEGACY|||||||0.242|||||||ANOVA|||Change at Week 3||||0.242
70936075|NCT00070707|141372923|SUPERIORITY_OR_OTHER_LEGACY|||||||0.696|||||||ANOVA|||Change at Week 4||||0.696
70936076|NCT00070707|141372923|SUPERIORITY_OR_OTHER_LEGACY|||||||0.67|||||||ANOVA|||Change at Final Week||||0.670
70936077|NCT00070707|141372924|SUPERIORITY_OR_OTHER_LEGACY|||||||0.865|||||||ANOVA|||Baseline||||0.865
70936078|NCT00070707|141372924|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025|||||||ANOVA|||Change at Week 1||||0.025
70936079|NCT00070707|141372924|SUPERIORITY_OR_OTHER_LEGACY|||||||0.288|||||||ANOVA|||Change at Week 2||||0.288
70936080|NCT00070707|141372924|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79|||||||ANOVA|||Change at Week 3||||0.790
70936081|NCT00070707|141372924|SUPERIORITY_OR_OTHER_LEGACY|||||||0.211|||||||ANOVA|||Change at Week 4||||0.211
70936082|NCT00070707|141372924|SUPERIORITY_OR_OTHER_LEGACY|||||||0.136|||||||ANOVA|||Change at Final Week||||0.136
70936083|NCT00070707|141372925|SUPERIORITY_OR_OTHER_LEGACY|||||||0.667|||||||ANOVA|||Baseline||||0.667
70936084|NCT00070707|141372925|SUPERIORITY_OR_OTHER_LEGACY|||||||0.656|||||||ANOVA|||Change at Week 1||||0.656
70936085|NCT00070707|141372925|SUPERIORITY_OR_OTHER_LEGACY|||||||0.458|||||||ANOVA|||Change at Week 2||||0.458
70936086|NCT00070707|141372925|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22|||||||ANOVA|||Change at Week 3||||0.220
70936087|NCT00070707|141372925|SUPERIORITY_OR_OTHER_LEGACY|||||||0.775|||||||ANOVA|||Change at Week 4||||0.775
70936088|NCT00070707|141372925|SUPERIORITY_OR_OTHER_LEGACY|||||||0.994|||||||ANOVA|||Change at Final Week||||0.994
70936089|NCT00070707|141372926|SUPERIORITY_OR_OTHER_LEGACY|||||||0.363|||||||ANOVA|||Baseline||||0.363
70936090|NCT00070707|141372926|SUPERIORITY_OR_OTHER_LEGACY|||||||0.262|||||||ANOVA|||Change at Week 1||||0.262
70936091|NCT00070707|141372926|SUPERIORITY_OR_OTHER_LEGACY|||||||0.386|||||||ANOVA|||Change at Week 2||||0.386
70936092|NCT00070707|141372926|SUPERIORITY_OR_OTHER_LEGACY|||||||0.167|||||||ANOVA|||Change at Week 3||||0.167
70936093|NCT00070707|141372926|SUPERIORITY_OR_OTHER_LEGACY|||||||0.505|||||||ANOVA|||Change at Week 4||||0.505
70936094|NCT00070707|141372926|SUPERIORITY_OR_OTHER_LEGACY|||||||0.725|||||||ANOVA|||Change at Final Week||||0.725
70936095|NCT00070707|141372927|SUPERIORITY_OR_OTHER_LEGACY|||||||0.954|||||||Cochran-Mantel-Haenszel|Stratified by center||Asthma Symptoms: Day 15||||0.954
70936096|NCT00070707|141372927|SUPERIORITY_OR_OTHER_LEGACY|||||||0.295|||||||Cochran-Mantel-Haenszel|Stratified by center||Asthma Symptoms: Day 29||||0.295
70936097|NCT00070707|141372928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.268|||||||Cochran-Mantel-Haenszel|Stratified by center||SAR Nasal Symptoms: Day 15||||0.268
70936098|NCT00070707|141372928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.154|||||||Cochran-Mantel-Haenszel|Stratified by center||SAR Nasal Symptoms: Day 29||||0.154
70936099|NCT01523392|141372929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-183.6|STANDARD_ERROR_OF_MEAN|14.68|<|0.001|TWO_SIDED|95.0|-213.9|-153.3||Model contained treatment group, period, and sequence as fixed effects and a random effect for patient within sequence|Mixed Models Analysis||Ticagrelor minus clopidogrel|||-153.3|-213.9|<0.001
71059882|NCT02028676|141626829|SUPERIORITY_OR_OTHER|||||||0.93|||||||Generalized estimating equations|Generalised estimating equation with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.93
71059883|NCT02028676|141626830|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.21|||<|0.001|TWO_SIDED|95.0|1.5|3.25|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||3.25|1.50|<0.001
71059884|NCT02028676|141626831|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.47||||0.44|TWO_SIDED|95.0|0.56|3.85|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||3.85|0.56|0.44
71059885|NCT02028676|141626832|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.4||||0.03|TWO_SIDED|95.0|1.05|5.48|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||5.48|1.05|0.03
71059886|NCT02028676|141626833|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.98||||0.18|TWO_SIDED|95.0|0.44|35.7|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||35.7|0.44|0.18
71059887|NCT02028676|141626834|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.8||||0.34|TWO_SIDED|95.0|0.53|6.17|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||6.17|0.53|0.34
71059888|NCT02028676|141626835|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.68|TWO_SIDED|95.0|0.12|4.15|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||4.15|0.12|0.68
71059889|NCT02028676|141626836|SUPERIORITY_OR_OTHER|||||||0.07|||||||Generalised estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.07
71059890|NCT02028676|141626837|SUPERIORITY_OR_OTHER|||||||0.19|||||||Generalised estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.19
71059891|NCT02028676|141626838|SUPERIORITY_OR_OTHER|||||||0.34|||||||Generalised estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.34
71059892|NCT02028676|141626839|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.13|TWO_SIDED|95.0|-1.4|0.2|||Regression, Linear|Adjusted for randomization stratification factors|Difference is stop minus continue|||0.2|-1.4|0.13
71059893|NCT02028676|141626840|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.0||||0.68|TWO_SIDED|95.0|-65.0|42.0|||Regression, Linear|Adjusted for randomization stratification factors|Difference is stop minus continue|||42|-65|0.68
71059894|NCT02028676|141626841|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.04|TWO_SIDED|95.0|1.02|2.5|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||2.50|1.02|0.04
71059895|NCT02028676|141626842|SUPERIORITY_OR_OTHER|||||||0.21||||||Adjusted for randomization stratification factors|Generalised estimating equation|Generalised estimating equation with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.21
71059896|NCT03051672|141626871|SUPERIORITY|||||||||||||The study terminated at stage 1 and no p-value was estimated.||||The study uses a Simon 2-stage design. In stage 1, if \>/=1 of 8 achieved OR then continue to stage 2 (enroll 19 more). If \>/= 3 of 27 respond, the regimen would be considered promising. The null ORR\<= 3% and alternative ORR\>/=20%. With this design, the probability of stopping the trial early is 58% if the true ORR is 3%. This design at 80% power to declare the combination effective, while controlling for less than 5% 1-sided type I error under the null hypothesis.|The study terminated at stage 1 and no p-value was estimated.|||
71059897|NCT04211831|141626875|OTHER||Least square mean difference|-1.29|||=|0.1722|TWO_SIDED|95.0|-3.16|0.58|||mixed model for repeated measures||Treatment comparison between Placebo and URO-902 24 mg using least sqaure mean difference and 95% confidence interval (CI) has been presented.|||0.58|-3.16|=0.1722
71059898|NCT04211831|141626875|OTHER||Least Square Mean Difference|-2.24|||=|0.0159|TWO_SIDED|95.0|-4.04|-0.43|||Mixed model for repeated measures||Treatment comparison between Placebo and URO-902 48 mg using least sqaure mean difference and 95% CI has been presented.|||-0.43|-4.04|=0.0159
71077977|NCT00703326|141664449|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.15|TWO_SIDED|95.0|0.67|1.06|||Stratified Log Rank (SLR)|SLR used Interactive Web Response System (IWRS) factors: prior taxane therapy, visceral metastasis, hormone receptor status and geographical regions.|HR with 95% confidence interval (CI) was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors.|||1.06|0.67|0.150
71077978|NCT00703326|141664450|SUPERIORITY_OR_OTHER_LEGACY|||||||0.539||||||P-value is for end of therapy. Analysis of covariance (ANCOVA) adjusted for baseline score was used to compare the 2 treatment arms.|ANCOVA|||||||0.539
71077979|NCT02242019|141664455|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71077980|NCT02242019|141664456|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71077981|NCT03214679|141664483|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<.001
71077982|NCT01601067|141664488|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||.002
71077983|NCT01601067|141664489|SUPERIORITY|||||||0.91||||||heavy drinking days|Mixed Models Analysis|||||||.91
71077984|NCT02771860|141664500|SUPERIORITY||Mean Difference (Final Values)|8.9||||0.024|TWO_SIDED|95.0|1.0|16.9|||GEE|||Comparison between groups was done by Generalized Estimation Equations at joint level, accounting for within-patient clustering and adjusted for baseline unbalances. Missing values were imputed according to a predefined imputation model, including randomization group, baseline value and values at other time points available, presence of baseline inflammation, baseline number of affected joints.||16.9|1.0|0.024
71077985|NCT02771860|141664501|SUPERIORITY||Odds Ratio (OR)|0.23|||<|0.001|TWO_SIDED|95.0|0.11|0.5|||Regression, Logistic|||||0.50|0.11|<0.001
71077986|NCT02771860|141664502|SUPERIORITY||Mean Difference (Final Values)|14.3||||0.003|TWO_SIDED|95.0|4.6|24.0|||GEE|||Comparison between groups was done by Generalized Estimation Equations at joint level, accounting for within-patient clustering and adjusted for baseline unbalances. Missing values were imputed according to a predefined imputation model, including randomization group, baseline value and values at other time points available, presence of baseline inflammation, baseline number of affected joints.||24.0|4.6|0.003
70936100|NCT01523392|141372930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-103.8|STANDARD_ERROR_OF_MEAN|18.79|<|0.001|TWO_SIDED|95.0|-142.5|-65.0|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|Analysis at 0.5 hours after loading dose||-65.0|-142.5|<0.001
70936101|NCT01523392|141372930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-165.3|STANDARD_ERROR_OF_MEAN|15.45|<|0.001|TWO_SIDED|95.0|-197.4|-133.3|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|Analysis at 8 hours after loading dose||-133.3|-197.4|<0.001
70936102|NCT01523392|141372931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-135.0|STANDARD_ERROR_OF_MEAN|12.35|<|0.001|TWO_SIDED|95.0|-160.4|-109.5|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|Analysis at 2 hours on Day 7 after multiple doses||-109.5|-160.4|<0.001
70936103|NCT01523392|141372931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-118.1|STANDARD_ERROR_OF_MEAN|12.55|<|0.001|TWO_SIDED|95.0|-143.9|-92.2|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|Analysis at 8 hours on Day 7 after multiple doses||-92.2|-143.9|<0.001
71027957|NCT03587207|141562869|OTHER|Serogroup W- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|1.06|||||TWO_SIDED|80.0|0.87|1.29|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup W, one month after last vaccination.||1.29|0.87|
71027958|NCT03587207|141562869|OTHER|Serogroup Y- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|1.18|||||TWO_SIDED|80.0|0.9|1.55|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup Y, one month after last vaccination.||1.55|0.90|
70936104|NCT01523392|141372931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-133.4|STANDARD_ERROR_OF_MEAN|12.77|<|0.001|TWO_SIDED|95.0|-159.7|-107.1|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|Analysis at end of dosing interval on Day 8||-107.1|-159.7|<0.001
71027959|NCT03587207|141562869|OTHER|M14459 strain- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV group.|Geometric mean ratio|1.02|||||TWO_SIDED|80.0|0.85|1.22|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B M14459(fHbp) strain, one month after last vaccination.||1.22|0.85|
71027960|NCT03587207|141562869|OTHER|96217 strain-Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV group.|Geometric mean ratio|0.9|||||TWO_SIDED|80.0|0.75|1.09|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after last vaccination.||1.09|0.75|
71027961|NCT03587207|141562869|OTHER|NZ98/254 strain-Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV group.|Geometric mean ratio|0.78|||||TWO_SIDED|80.0|0.64|0.96|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.||0.96|0.64|
71027962|NCT03587207|141562869|OTHER|M07-0241084 strain-Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV group.|Geometric mean ratio|0.71|||||TWO_SIDED|80.0|0.58|0.86|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.||0.86|0.58|
71027963|NCT03587207|141562869|OTHER|Serogroup A- Between group ratio for comparison of rMenBOMV+ACWY\_S group and MenACWY group.|Geometric mean ratio|3.6|||||TWO_SIDED|80.0|2.9|4.47|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus MenACWY study groups, on the Meningitis serogroup A, one month after last vaccination.||4.47|2.90|
71077987|NCT01212159|141664539|SUPERIORITY_OR_OTHER|||||||0.391|TWO_SIDED|||||Comparison of mean reduction in LDL cholesterol between no monitor (control) and monitor (intervention) groups|t-test, 2 sided|||Paired t-test analysis of 6 month change in LDL cholesterol for no monitor and self monitor groups Independent sample t-test to compare ldl change between groups||||0.391
71077988|NCT02081014|141664544|SUPERIORITY_OR_OTHER||Point estimate ratio|0.62|STANDARD_ERROR_OF_MEAN|0.07|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
71077989|NCT02081014|141664544|SUPERIORITY_OR_OTHER||Point estimate ratio|0.35|STANDARD_ERROR_OF_MEAN|0.04|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
71077990|NCT02081014|141664544|SUPERIORITY_OR_OTHER||Point estimate ratio|0.57|STANDARD_ERROR_OF_MEAN|0.06|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
71077991|NCT02081014|141664545|SUPERIORITY_OR_OTHER||Point estimate ratio|0.74|STANDARD_ERROR_OF_MEAN|0.06|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
71077992|NCT02081014|141664545|SUPERIORITY_OR_OTHER||Point estimate ratio|0.44|STANDARD_ERROR_OF_MEAN|0.04|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
71077993|NCT02081014|141664545|SUPERIORITY_OR_OTHER||Point estimate ratio|0.59|STANDARD_ERROR_OF_MEAN|0.05|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
71077994|NCT02081014|141664546|SUPERIORITY_OR_OTHER||Point point ratio|0.68|STANDARD_ERROR_OF_MEAN|0.05|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
71077995|NCT02081014|141664546|SUPERIORITY_OR_OTHER||Point estimate ratio|0.36|STANDARD_ERROR_OF_MEAN|0.03|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
71077996|NCT02081014|141664546|SUPERIORITY_OR_OTHER||Point estimate ratio|0.53|STANDARD_ERROR_OF_MEAN|0.04|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
70936105|NCT01377844|141372940|SUPERIORITY||Difference of LS Means|-0.79|||<|0.0001|TWO_SIDED|95.0|-1.06|-0.53||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||||-0.53|-1.06|< 0.0001
70936106|NCT01377844|141372941|SUPERIORITY||Difference of LS Means|-5.53|||<|0.0001|TWO_SIDED|95.0|-8.02|-3.04||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline systolic BP, baseline HbA1c category, site, age category, gender and race||||-3.04|-8.02|< 0.0001
70936107|NCT01377844|141372941|SUPERIORITY||Difference of LS Means|-2.67||||0.0015|TWO_SIDED|95.0|-4.3|-1.04||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline diastolic BP, baseline HbA1c category, site, age category, gender and race||||-1.04|-4.30|0.0015
71027964|NCT03587207|141562869|OTHER|Serogroup C- Between group ratio for comparison of rMenBOMV+ACWY\_S group and MenACWY group.|Geometric mean ratio|4.18|||||TWO_SIDED|80.0|3.28|5.31|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus MenACWY study groups, on the Meningitis serogroup C, one month after last vaccination.||5.31|3.28|
71027965|NCT03587207|141562869|OTHER|Serogroup W- Between group ratio for comparison of rMenBOMV+ACWY\_S group and MenACWY group.|Geometric mean ratio|3.07|||||TWO_SIDED|80.0|2.52|3.73|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus MenACWY study groups, on the Meningitis serogroup W, one month after last vaccination.||3.73|2.52|
70936108|NCT01377844|141372942|SUPERIORITY||Difference of LS Means|-1.72|||<|0.0001|TWO_SIDED|95.0|-2.52|-0.93||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline weight, baseline HbA1c category, site, age category, gender and race||||-0.93|-2.52|< 0.0001
70936109|NCT01377844|141372943|SUPERIORITY||Difference of LS Means|-0.32|||<|0.0001|TWO_SIDED|95.0|-0.42|-0.21||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 2||-0.21|-0.42|< 0.0001
70936110|NCT01377844|141372943|SUPERIORITY||Difference of LS Means|-0.59|||<|0.0001|TWO_SIDED|95.0|-0.78|-0.41||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 6||-0.41|-0.78|< 0.0001
71027966|NCT03587207|141562869|OTHER|Serogroup Y- Between group ratio for comparison of rMenBOMV+ACWY\_S group and MenACWY group.|Geometric mean ratio|2.01|||||TWO_SIDED|80.0|1.53|2.65|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus MenACWY study groups, on the Meningitis serogroup Y, one month after last vaccination.||2.65|1.53|
71027967|NCT03587207|141562869|OTHER|M14459 strain- Between group ratio for comparison of rMenBOMV+ACWY\_D group and rMenBOMV group.|Geometric mean ratio|1.02|||||TWO_SIDED|80.0|0.85|1.22|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B M14459 (fHbp) strain, one month after last vaccination.||1.22|0.85|
71027968|NCT03587207|141562869|OTHER|96217 strain- Between group ratios for comparison of rMenBOMV+ACWY\_D group and rMenBOMV group|Geometric mean ratio|0.86|||||TWO_SIDED|80.0|0.71|1.04|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after last vaccination.||1.04|0.71|
71027969|NCT03587207|141562869|OTHER|NZ98/254 strain-Between group ratio for comparison of rMenBOMV+ACWY\_D group and rMenBOMV group.|Geometric mean ratio|1.01|||||TWO_SIDED|80.0|0.82|1.24|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.||1.24|0.82|
71027970|NCT03587207|141562869|OTHER|M07-0241084 strain-Between group ratio for comparison of rMenBOMV+ACWY\_D group and rMenBOMV group.|Geometric mean ratio|0.89|||||TWO_SIDED|80.0|0.73|1.09|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.||1.09|0.73|
71027971|NCT03587207|141562869|OTHER|Serogroup A-Between group ratio for comparison of rMenBOMV+ACWY\_D group and MenACWY group.|Geometric mean ratio|3.92|||||TWO_SIDED|80.0|3.15|4.88|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus MenACWY study groups, on the Meningitis serogroup A, one month after last vaccination.||4.88|3.15|
71027972|NCT03587207|141562869|OTHER|Serogroup C- Between group ratio for comparison of rMenBOMV+ACWY\_D group and MenACWY group.|Geometric mean ratio|4.19|||||TWO_SIDED|80.0|3.3|5.34|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus MenACWY study groups, on the Meningitis serogroup C, one month after last vaccination.||5.34|3.30|
71059899|NCT01256879|141626878|OTHER|Each CimTest-A, CimTest-B, and Commercial Cimetidine Solution are compared to Active Comparator (i.e. Sorbitol-free Cimetidine Solution), as a percentage of Active Comparator, per routine FDA bioequivalence testing of AUC.|||||||||||||||||Bioequivalence testing of AUC, per FDA guidance, is applied. Each CimTest-A, CimTest-B, and Commercial Cimetidine Solution are compared to Active Comparator (i.e. Sorbitol-free Cimetidine Solution), as a percentage of Active Comparator, per routine FDA bioequivalence testing of AUC. The upper and lower 90% Confidence Interval for CimTest-A is 104.4% to 120.6%. The upper and lower 90% Confidence Interval for CimTest-B is 97.9% to 113.0%. The upper and lower 90% Confidence Interval for Commercial Cimetidine Solution is 93.2% to 107.7%.|||
71059900|NCT03493685|141626889|OTHER||Slope difference|0.3|STANDARD_ERROR_OF_MEAN|1.05||0.7491|TWO_SIDED|95.0|-1.74|2.41|||Mixed Models Analysis|||||2.41|-1.74|0.7491
71059901|NCT03493685|141626890|OTHER||Risk Difference (RD)|16.0||||0.0094|TWO_SIDED|95.0|3.96|28.04|||Mixed Models Analysis|||||28.04|3.96|0.0094
71059902|NCT03493685|141626891|OTHER||Slope difference|0.9|STANDARD_ERROR_OF_MEAN|1.09||0.4203|TWO_SIDED|95.0|-1.27|3.04|||Mixed Models Analysis|||||3.04|-1.27|0.4203
71059903|NCT03493685|141626892|OTHER||Mean Difference (Final Values)|1.8||||0.2708|TWO_SIDED|95.0|-1.39|4.93|||ANCOVA|||||4.93|-1.39|0.2708
71059904|NCT03300817|141626896|SUPERIORITY|||||||0.6834|||||||Wilcoxon Rank-Sum test|||||||0.6834
71059905|NCT04467840|141626938|SUPERIORITY||Risk Difference (RD)|3.86||||0.391|TWO_SIDED|95.0|-4.93|12.65||The threshold for statistical significance was p = 0.05|Cochran-Mantel-Haenszel||Opaganib - Placebo|||12.65|-4.93|0.391
71059906|NCT04467840|141626939|SUPERIORITY||Risk Difference (RD)|3.91||||0.38|TWO_SIDED|95.0|-4.78|12.6||The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Cochran-Mantel-Haenszel|||||12.60|-4.78|0.380
71059907|NCT04467840|141626940|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.231|TWO_SIDED|95.0|0.91|1.45||The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Log Rank|||||1.45|0.91|0.231
71059908|NCT04467840|141626941|SUPERIORITY||Hazard Ratio, log|1.08||||0.472|TWO_SIDED|95.0|0.87|1.33||The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Log Rank|||||1.33|0.87|0.472
71059909|NCT04467840|141626942|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.521|TWO_SIDED|95.0|0.846|1.378||The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Log Rank|||||1.378|0.846|0.521
71059910|NCT04467840|141626943|SUPERIORITY||Risk Difference (RD)|-1.51||||0.701|TWO_SIDED|95.0|-9.19|6.18||The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Cochran-Mantel-Haenszel|||||6.18|-9.19|0.701
71059911|NCT04467840|141626944|SUPERIORITY|The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Hazard Ratio (HR)|1.34||||0.043|TWO_SIDED|95.0|0.99|1.82|||Log Rank|||||1.82|0.99|0.043
71059912|NCT04467840|141626945|SUPERIORITY|The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Risk Difference (RD)|8.3||||0.118|TWO_SIDED|95.0|-2.05|18.65|||Cochran-Mantel-Haenszel|||||18.65|-2.05|0.118
71059913|NCT04467840|141626949|SUPERIORITY||Risk Difference (RD)|12.28||||0.033|TWO_SIDED|95.0|1.06|23.5||unadjusted p-value|Cochran-Mantel-Haenszel|||||23.50|1.06|0.033
71059914|NCT04467840|141626950|SUPERIORITY||Risk Difference (RD)|-4.75||||0.5|TWO_SIDED|95.0|-18.67|9.17|||Cochran-Mantel-Haenszel|||||9.17|-18.67|0.500
71059915|NCT04467840|141626951|SUPERIORITY||Risk Difference (RD)|12.75||||0.023|TWO_SIDED|95.0|1.9|23.6|||Cochran-Mantel-Haenszel|||||23.60|1.90|0.023
71059916|NCT04467840|141626952|SUPERIORITY||Risk Difference (RD)|-4.12||||0.561|TWO_SIDED|95.0|-18.07|9.82|||Cochran-Mantel-Haenszel|||||9.82|-18.07|0.561
71059917|NCT04467840|141626953|SUPERIORITY||Hazard Ratio (HR)|1.44||||0.01|TWO_SIDED|95.0|1.07|1.93|||Log Rank|||||1.93|1.07|0.01
71059918|NCT04467840|141626954|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.545|TWO_SIDED|95.0|0.58|1.34|||Log Rank|||||1.34|0.58|0.545
71059919|NCT04467840|141626955|SUPERIORITY||Hazard Ratio (HR)|1.276||||0.1|TWO_SIDED|95.0|0.94|1.732|||Log Rank|||||1.732|0.940|0.100
71059920|NCT04467840|141626957|SUPERIORITY||Risk Difference (RD)|-10.5||||0.012|TWO_SIDED|95.0|-18.44|-2.57|||Cochran-Mantel-Haenszel|||||-2.57|-18.44|0.012
71059921|NCT04467840|141626958|SUPERIORITY||Risk Difference (RD)|7.2||||0.304|TWO_SIDED|95.0|-6.46|20.86|||Cochran-Mantel-Haenszel|||||20.86|-6.46|0.304
71059922|NCT04467840|141626959|SUPERIORITY||Risk Difference (RD)|-9.22||||0.019|TWO_SIDED|95.0|-16.63|-1.8|||Cochran-Mantel-Haenszel|||||-1.80|-16.63|0.019
71059923|NCT04467840|141626960|SUPERIORITY||Risk Difference (RD)|7.37||||0.273|TWO_SIDED|95.0|-5.66|20.39|||Cochran-Mantel-Haenszel|||||20.39|-5.66|0.273
71059924|NCT03503669|141627021|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71059925|NCT03503669|141627022|SUPERIORITY|||||||0.008|||||||Mixed Models Analysis|||||||0.008
71059926|NCT03503669|141627023|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71059927|NCT03503669|141627024|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71059928|NCT03503669|141627025|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71077997|NCT02081014|141664547|SUPERIORITY_OR_OTHER||Point estimate ratio|0.72|STANDARD_ERROR_OF_MEAN|0.04|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
71077998|NCT02081014|141664547|SUPERIORITY_OR_OTHER||Point estimate ratio|0.44|STANDARD_ERROR_OF_MEAN|0.02|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
71077999|NCT02081014|141664547|SUPERIORITY_OR_OTHER||Point estimate ratio|0.6|STANDARD_ERROR_OF_MEAN|0.03|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
71078000|NCT02081014|141664548|SUPERIORITY_OR_OTHER||Point esimate ratio|0.98|STANDARD_ERROR_OF_MEAN|0.14|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
71078001|NCT02081014|141664548|SUPERIORITY_OR_OTHER||Point estimate ratio|0.78|STANDARD_ERROR_OF_MEAN|0.11|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
71078002|NCT02081014|141664548|SUPERIORITY_OR_OTHER||Point estimate ratio|0.79|STANDARD_ERROR_OF_MEAN|0.11|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
71078003|NCT02081014|141664549|SUPERIORITY_OR_OTHER||Point estimate ratio|0.75|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
70936111|NCT01377844|141372943|SUPERIORITY||Difference of LS Means|-0.72|||<|0.0001|TWO_SIDED|95.0|-0.96|-0.48||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 12||-0.48|-0.96|< 0.0001
70936112|NCT01377844|141372943|SUPERIORITY||Difference of LS Means|-0.71|||<|0.0001|TWO_SIDED|95.0|-0.97|-0.44||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 18||-0.44|-0.97|< 0.0001
71027973|NCT03587207|141562869|OTHER|Serogroup W- Between group ratio for comparison of rMenBOMV+ACWY\_D group and MenACWY group.|Geometric mean ratio|3.17|||||TWO_SIDED|80.0|2.6|3.87|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus MenACWY study groups, on the Meningitis serogroup W, one month after last vaccination.||3.87|2.60|
71027974|NCT03587207|141562869|OTHER|Serogroup Y- Between group ratio for comparison of rMenBOMV+ACWY\_D group and MenACWY group.|Geometric mean ratio|2.22|||||TWO_SIDED|80.0|1.68|2.92|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus MenACWY study groups, on the Meningitis serogroup Y, one month after last vaccination.||2.92|1.68|
71027975|NCT03587207|141562869|OTHER|M14459- Between group ratios for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|1.05|||||TWO_SIDED|80.0|0.87|1.25|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B M14459 (fHbp) strain, one month after last vaccination.||1.25|0.87|
71027976|NCT03587207|141562869|OTHER|96217 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV group.|Geometric mean ratio|0.71|||||TWO_SIDED|80.0|0.59|0.86|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after last vaccination.||0.86|0.59|
71027977|NCT03587207|141562869|OTHER|NZ98/254 strain-Between group ratios for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.62|||||TWO_SIDED|80.0|0.5|0.76|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.||0.76|0.50|
71027978|NCT03587207|141562869|OTHER|M07-0241084 strain-Between group ratios for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.52|||||TWO_SIDED|80.0|0.42|0.63|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.||0.63|0.42|
71027979|NCT03587207|141562869|OTHER|Serogroup A- Between group ratios for comparison between MenABCWY group and MenACWY group|Geometric mean ratio|2.02|||||TWO_SIDED|80.0|1.62|2.51|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus MenACWY study groups, on the Meningitis serogroup A, one month after last vaccination.||2.51|1.62|
71027980|NCT03587207|141562869|OTHER|Serogroup C- Between group ratios for comparison of MenABCWY group and MenACWY group|Odds Ratio (OR)|4.99|||||TWO_SIDED|80.0|3.92|6.35|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus MenACWY study groups, on the Meningitis serogroup C, one month after last vaccination.||6.35|3.92|
71027981|NCT03587207|141562869|OTHER|Serogroup W- Between group ratios for comparison of MenABCWY group and MenACWY group|Geometric mean ratio|3.25|||||TWO_SIDED|80.0|2.66|3.96|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus MenACWY study groups, on the Meningitis serogroup W, one month after last vaccination.||3.96|2.66|
71027982|NCT03587207|141562869|OTHER|Serogroup Y- Between group ratio for comparison of MenABCWY group and MenACWY group|Geometric mean ratio|2.38|||||TWO_SIDED|80.0|1.81|3.12|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus MenACWY study groups, on the Meningitis serogroup Y, one month after last vaccination.||3.12|1.81|
71027983|NCT03587207|141562873|OTHER|Between group ratio is calculated as GMT for rMenBOMV+ACWY\_S Group over GMT for rMenBOMV+ACWY\_D Group. 80% CI are obtained from Analysis of Covariance model fitted to pooled Serogroup B Strains. The following ANCOVA model is used: fixed-effect model including age strata, study group, strain and center as fixed effects. The pre vaccination (Baseline) log-transformed titer with centering at zero is included as a continuous covariate.|Geometric mean ratio|1.02|||||TWO_SIDED|80.0|0.86|1.22|||ANCOVA|An interaction between strain and pre-vaccination log transformed titer is included in the model to fit to the serogroup B test strain data only.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the pooled B strains, one month after first vaccination.||1.22|0.86|
71027984|NCT03587207|141562874|OTHER|M14459 strain- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Geometric mean ratio|1.29|||||TWO_SIDED|80.0|1.02|1.63|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B M14459 (fHbp) strain, one month after first vaccination.||1.63|1.02|
70936113|NCT01377844|141372943|SUPERIORITY||Difference of LS Means|-0.79|||<|0.0001|TWO_SIDED|95.0|-1.06|-0.53||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 24||-0.53|-1.06|< 0.0001
70936114|NCT01377844|141372943|SUPERIORITY||Difference of LS Means|-0.93|||<|0.0001|TWO_SIDED|95.0|-1.21|-0.66||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 36||-0.66|-1.21|< 0.0001
70936115|NCT01377844|141372943|SUPERIORITY||Difference of LS Means|-0.99|||<|0.0001|TWO_SIDED|95.0|-1.28|-0.7||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 48||-0.70|-1.28|< 0.0001
70936116|NCT01377844|141372943|SUPERIORITY||Difference of LS Means|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.27|-0.68||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 60||-0.68|-1.27|< 0.0001
70936117|NCT01377844|141372943|SUPERIORITY||Difference of LS Means|-0.93|||<|0.0001|TWO_SIDED|95.0|-1.22|-0.64||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 72||-0.64|-1.22|< 0.0001
70936118|NCT01377844|141372943|SUPERIORITY||Difference of LS Means|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.27|-0.69||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 84||-0.69|-1.27|< 0.0001
70936119|NCT01377844|141372943|SUPERIORITY||Difference of LS Means|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.31|-0.73||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 96||-0.73|-1.31|< 0.0001
70936120|NCT01377844|141372944|SUPERIORITY||Difference of LS Means|-2.24|||<|0.0001|TWO_SIDED|95.0|-2.79|-1.7||The p-value is from a two-sided t-test for the difference in means of change from baseline|ANCOVA|Based on analysis of covariance, including treatment group, baseline FPG, baseline HbA1c category, site, age category, gender and race||Difference of mean-adjusted change from baseline in FPG (mmol/L) at Week 2, between EGT0001442 and Placebo group.||-1.70|-2.79|< 0.0001
70936121|NCT01377844|141372944|SUPERIORITY||Difference of LS Means|-2.45|||<|0.0001|TWO_SIDED|95.0|-3.09|-1.81||The p-value is from a two-sided t-test for the difference in means of change from baseline|ANCOVA|Based on analysis of covariance, including treatment group, baseline FPG, baseline HbA1c category, site, age category, gender and race||Difference of mean-adjusted change from baseline in FPG (mmol/L) at Week 6, between EGT0001442 and Placebo group.||-1.81|-3.09|< 0.0001
70936122|NCT01377844|141372944|SUPERIORITY||Difference of LS Means|-2.42|||<|0.0001|TWO_SIDED|95.0|-3.06|-1.77||The p-value is from a two-sided t-test for the difference in means of change from baseline|ANCOVA|Based on analysis of covariance, including treatment group, baseline FPG, baseline HbA1c category, site, age category, gender and race||Difference of mean-adjusted change from baseline in FPG (mmol/L) at Week 12, between EGT0001442 and Placebo group.||-1.77|-3.06|< 0.0001
70936123|NCT01377844|141372944|SUPERIORITY||Difference of LS Means|-2.71|||<|0.0001|TWO_SIDED|95.0|-3.3|-2.11||The p-value is from a two-sided t-test for the difference in means of change from baseline.|ANCOVA|Based on analysis of covariance, including treatment group, baseline FPG, baseline HbA1c category, site, age category, gender and race||Difference of mean-adjusted change from baseline in FPG (mmol/L) at Week 18, between EGT0001442 and Placebo group.||-2.11|-3.30|< 0.0001
70936124|NCT01377844|141372944|SUPERIORITY||Difference of LS Means|-2.63|||<|0.0001|TWO_SIDED|95.0|-3.24|-2.02||The p-value is from a two-sided t-test for the difference in means of change from baseline.|ANCOVA|Based on analysis of covariance, including treatment group, baseline FPG, baseline HbA1c category, site, age category, gender and race||Difference of mean-adjusted change from baseline in FPG (mmol/L) at Week 24, between EGT0001442 and Placebo group.||-2.02|-3.24|< 0.0001
70936125|NCT02236611|141372951|NON_INFERIORITY_OR_EQUIVALENCE|Alternate hypothesis: the difference between the trt means (umeclidinium minus glycopyrronium) would be \> -50 milliliters (mL). If the lower CI (2.5% 1-sided significance level) of the statistical test should fall above -50 mL, then umeclidinium may be deemed statistically non-inferior to glycopyrronium. If the lower CI (2.5% 1-sided significance) of the statistical testing exceeded 0 then, umeclidinium may be deemed statistically superior to glycopyrronium.|Mean Difference (Final Values)|0.024||||0.1|TWO_SIDED|95.0|-0.005|0.054|||Mixed Models Analysis|||||0.054|-0.005|0.100
71078004|NCT02081014|141664549|SUPERIORITY_OR_OTHER||Point estimate ratio|0.73|STANDARD_ERROR_OF_MEAN|0.1|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
70936126|NCT00240994|141372971|SUPERIORITY_OR_OTHER||Proportion with graft loss or death|0.057|||||TWO_SIDED|95.0|0.007|0.192|||95% Confidence Interval|95% CI using an exact binomial method||The proportion of participants with graft loss or death within 12 months post kidney transplantation is descriptively summarized with a 95% confidence interval using an exact binomial method.||0.192|0.007|
70936127|NCT00854594|141372988|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis: pre-intervention efficacies will be equal in the two study arms.||||0.26
70936128|NCT00854594|141372989|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis: post-intervention efficacies will be equal in the two study arms.||||0.74
70936129|NCT00749944|141372991|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.72|||||TWO_SIDED|95.0|-0.33|1.77||||||There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.77|-0.33|
70936130|NCT00749944|141372991|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.46|||||TWO_SIDED|95.0|-0.5|1.43||||||Period AC: Difference varenicline versus placebo.||1.43|-0.50|
70936131|NCT00749944|141372991|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.92|||||TWO_SIDED|95.0|-0.27|2.11||||||Period AD: Difference varenicline versus placebo.||2.11|-0.27|
71059929|NCT01269918|141627026|NON_INFERIORITY_OR_EQUIVALENCE|We used a noninferiority delta of 7.5 mmHg. If noninferiority was detected, we proceeded to test for superiority.|Mean Difference (Final Values)|-9.0|||<|0.001|TWO_SIDED|95.0|-13.0|-5.0|||t-test, 1 sided|||Dexmedetomidine versus remifentanyl on MAP collapsed over time was estimated using a 1-tailed t test from a repeated measures ANOVA model.||-5|-13|< 0.001
71059930|NCT01269918|141627026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|||<|0.001|TWO_SIDED|97.5|-13.0|-4.0|||t-test, 1 sided|||Dexmedetomidine versus remifentanyl on MAP collapsed over time was estimated using a 1-tailed t test from a repeated measures ANOVA model.||-4|-13|< 0.001
71059931|NCT01269918|141627027|NON_INFERIORITY_OR_EQUIVALENCE|We used a noninferiority delta of 1 point. If noninferiority was detected, we proceeded to test for superiority.|Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.7|-1.1|||t-test, 1 sided|||Dexmedetomidine versus remifentanyl on VAS pain score estimated from a 1-tailed t test from a repeated measures ANOVA model.||-1.1|-2.7|< 0.001
71059932|NCT01269918|141627027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|97.5|-2.8|-0.9|||t-test, 1 sided|||Dexmedetomidine versus remifentanyl on VAS pain score estimated from a 1-tailed t test from a repeated measures ANOVA model.||-0.9|-2.8|< 0.001
71059933|NCT01269918|141627028|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority delta = 2 mg opioid|Median Difference (Final Values)|-5.0|||<|0.001|TWO_SIDED|95.0|-10.0|-5.0|||Wilcoxon (Mann-Whitney)|||Dexmedetomidine versus remifentanyl on opioid consumption estimated from a Wilcoxon rank sum test||-5|-10|< 0.001
71059934|NCT01269918|141627028|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-5.0|||<|0.001|TWO_SIDED|97.5|-10.0|-3.0|||Wilcoxon (Mann-Whitney)|||Dexmedetomidine versus remifentanyl on opioid consumption estimated from a Wilcoxon rank sum test||-3|-10|< 0.001
71059935|NCT01269918|141627029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0|||<|0.001|TWO_SIDED|95.0|-10.0|3.0|||Mixed Models Analysis|||Dexmedetomidine versus remifentanyl on heart rate was assessed using a linear mixed effects model adjusting for baseline heart rate.||3|-10|< 0.001
71059936|NCT01269918|141627030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.16|TWO_SIDED|95.0|-2.6|0.5|||Mixed Models Analysis|||Dexmedetomidine versus remifentanyl on SOMCT estimated using a linear mixed effects model adjusting for baseline SOMCT score.||0.5|-2.6|0.16
71059937|NCT01269918|141627031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.07|TWO_SIDED|95.0|-0.6|0.03|||Mixed Models Analysis|||Dexmedetomidine versus remifentanyl on Aldrete score estimated using a linear mixed effects model adjusting for baseline Aldrete score.||0.03|-0.6|0.07
71059938|NCT01269918|141627032|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0||||0.009|TWO_SIDED|95.0|-1.0|-0.001|||Wilcoxon (Mann-Whitney)|||Dexmedetomidine versus remifentanyl on Nursing workload comparison estimated using a Wilcoxon rank sum test.||-0.001|-1|0.009
71059939|NCT01269918|141627033|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.11|||<|0.001|TWO_SIDED|95.0|0.07|0.18|||Regression, Cox|||Remifentanyl versus Dexmedetomidine on time to open eyes estimated using Cox regression.||0.18|0.07|< 0.001
71059940|NCT01269918|141627034|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.12|||<|0.001|TWO_SIDED|95.0|0.07|0.19|||Regression, Cox|||Remifentanyl versus dexmedetomidine on time to recall assessed using Cox regression.||0.19|0.07|< 0.001
71059941|NCT01269918|141627035|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.022|TWO_SIDED|95.0|0.48|0.95|||Regression, Cox|||Remifentanyl versus Dexmedetomidine on time to fitness discharge estimated using Cox regression.||0.95|0.48|0.022
70852297|NCT03060551|141193176|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.034||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.034
70936132|NCT00749944|141372991|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.5|||||TWO_SIDED|95.0|-0.52|1.53||||||Period AE: Difference varenicline versus placebo.||1.53|-0.52|
71059942|NCT01269918|141627036|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.45|TWO_SIDED|95.0|0.81|1.62|||Regression, Cox|||Remifentanyl versus Dexmedetomidine on time to PACU discharge estimated using Cox proportional hazard regression||1.62|0.81|0.45
71059943|NCT01269918|141627037|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.91|TWO_SIDED|95.0|0.5|2.2|||Chi-squared|||Dexmedetomidine versus remifentanyl on postoperative nausea estimated from chi squared test.||2.2|0.5|0.91
71059944|NCT01269918|141627038|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.4||||0.16|TWO_SIDED|95.0|0.07|1.7|||Chi-squared|||Dexmedetomidine versus remifentanyl on postoperative vomiting estimated from a chi square test.||1.7|0.07|0.16
71059945|NCT01269918|141627039|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.4||||0.21|TWO_SIDED|95.0|0.1|1.7|||Chi-squared|||Dexmedetomidine versus remifentanyl on incidence of shivering estimated from a chi square test.||1.7|0.1|0.21
71059946|NCT04471428|141627051|SUPERIORITY|Stratified Analysis: Stratification factors include histology, and prior NSCLC treatment regimens|Hazard Ratio (HR)|0.884||||0.3668|TWO_SIDED|95.0|0.676|1.156|||Log Rank||Hazard ratio was estimated by Cox regression model.|||1.156|0.676|0.3668
71059947|NCT04471428|141627051|SUPERIORITY||Hazard Ratio (HR)|0.907||||0.4709|TWO_SIDED|95.0|0.696|1.182|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||1.182|0.696|0.4709
71059948|NCT04471428|141627052|SUPERIORITY||Hazard Ratio (HR)|0.735||||0.0079|TWO_SIDED|95.0|0.585|0.923|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factors include histology, and prior NSCLC treatment regimens||0.923|0.585|0.0079
71059949|NCT04471428|141627052|SUPERIORITY||Hazard Ratio (HR)|0.731||||0.0061|TWO_SIDED|95.0|0.583|0.915|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified analysis||0.915|0.583|0.0061
71059950|NCT04471428|141627053|SUPERIORITY||Difference in Response Rates|-1.51||||0.6846|TWO_SIDED|95.0|-8.85|5.84|||Cochran-Mantel-Haenszel||95% CIs was computed using the Wald method.|Stratified analysis; stratification factors- histology, prior NSCLC treatment regimens||5.84|-8.85|0.6846
71059951|NCT04471428|141627053|SUPERIORITY||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.47|1.63|||||Odds ratios were estimated by logistic regression. 95% CIs was computed using the Wald method.|Stratified analysis; stratification factors- histology, prior NSCLC treatment regimens||1.63|0.47|
70936133|NCT00749944|141372991|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.43|||||TWO_SIDED|95.0|-1.35|0.5|||||Mixed Models Analysis|Period BC: Difference varenicline versus placebo.||0.50|-1.35|
70936134|NCT00749944|141372991|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.03|||||TWO_SIDED|95.0|-1.18|1.24||||||Period BD: Difference varenicline versus placebo.||1.24|-1.18|
70936135|NCT00749944|141372991|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.37|||||TWO_SIDED|95.0|-1.37|0.63|||||Mixed Models Analysis|Period BE: Difference varenicline versus placebo.||0.63|-1.37|
70936136|NCT00749944|141372992|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.62|||||TWO_SIDED|95.0|-0.15|1.39||||||There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.39|-0.15|
70936137|NCT00749944|141372992|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.41|||||TWO_SIDED|95.0|-0.24|1.07||||||Period AC: Difference varenicline versus placebo.||1.07|-0.24|
70936138|NCT00749944|141372992|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.48|||||TWO_SIDED|95.0|-0.26|1.22||||||Period AD: Difference varenicline versus placebo.||1.22|-0.26|
70936139|NCT00749944|141372992|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.44|||||TWO_SIDED|95.0|-0.18|1.06||||||Period AE: Difference varenicline versus placebo.||1.06|-0.18|
70936140|NCT00749944|141372992|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.1|||||TWO_SIDED|95.0|-0.58|0.78||||||Period BC: Difference varenicline versus placebo.||0.78|-0.58|
70936141|NCT00749944|141372992|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.22|||||TWO_SIDED|95.0|-0.48|0.92||||||Period BD: Difference varenicline versus placebo.||0.92|-0.48|
70936142|NCT00749944|141372992|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.23|||||TWO_SIDED|95.0|-0.26|0.72||||||Period BE: Difference varenicline versus placebo.||0.72|-0.26|
70936143|NCT00749944|141372993|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.62|||||TWO_SIDED|95.0|0.0|1.24||||||There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.24|-0.00|
70936144|NCT00749944|141372993|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.73|||||TWO_SIDED|95.0|0.18|1.29||||||Period AC: Difference varenicline versus placebo.||1.29|0.18|
71027985|NCT03587207|141562874|OTHER|96217 strain- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Geometric mean ratio|0.93|||||TWO_SIDED|80.0|0.75|1.15|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B 96217 (NadA) strain, one month after first vaccination.||1.15|0.75|
71027986|NCT03587207|141562874|OTHER|NZ98/254 strain- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Geometric mean ratio|1.01|||||TWO_SIDED|80.0|0.8|1.29|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B NZ98/254 (PorA)strain, one month after first vaccination.||1.29|0.80|
71027987|NCT03587207|141562874|OTHER|M07-0241084 strain-Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Odds Ratio (OR)|1.08|||||TWO_SIDED|80.0|0.87|1.36|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after first vaccination.||1.36|0.87|
71027988|NCT03587207|141562874|OTHER|Serogroup A- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Geometric mean ratio|0.77|||||TWO_SIDED|80.0|0.58|1.03|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup A, one month after first vaccination.||1.03|0.58|
71027989|NCT03587207|141562874|OTHER|Serogroup C- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D Group.|Geometric mean ratio|0.84|||||TWO_SIDED|80.0|0.62|1.13|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup C, one month after first vaccination.||1.13|0.62|
71027990|NCT03587207|141562874|OTHER|Serogroup W- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Geometric mean ratio|0.88|||||TWO_SIDED|80.0|0.68|1.13|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup W, one month after first vaccination.||1.13|0.68|
71027991|NCT03587207|141562874|OTHER|Serogroup Y- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Geometric mean ratio|0.76|||||TWO_SIDED|80.0|0.54|1.08|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup Y, one month after first vaccination.||1.08|0.54|
71027992|NCT03587207|141562874|OTHER|M14459 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.87|||||TWO_SIDED|80.0|0.69|1.09|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B M14459 (fHbp) strain, one month after first vaccination.||1.09|0.69|
71027993|NCT03587207|141562874|OTHER|96217 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.73|||||TWO_SIDED|80.0|0.58|0.9|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B 96217 (NadA) strain, one month after first vaccination.||0.90|0.58|
71027994|NCT03587207|141562874|OTHER|NZ98/254 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.78|||||TWO_SIDED|80.0|0.61|1.0|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after first vaccination.||1.00|0.61|
71027995|NCT03587207|141562874|OTHER|M07-0241084 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.86|||||TWO_SIDED|80.0|0.68|1.07|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after first vaccination.||1.07|0.68|
70936145|NCT00749944|141372993|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.66|||||TWO_SIDED|95.0|0.02|1.3||||||Period AD: Difference varenicline versus placebo.||1.30|0.02|
71027996|NCT03587207|141562874|OTHER|Serogroup A- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.46|||||TWO_SIDED|80.0|0.35|0.62|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup A, one month after first vaccination.||0.62|0.35|
71027997|NCT03587207|141562874|OTHER|Serogroup C- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|1.22|||||TWO_SIDED|80.0|0.91|1.65|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup C, one month after first vaccination.||1.65|0.91|
71027998|NCT03587207|141562874|OTHER|Serogroup W- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|1.34|||||TWO_SIDED|80.0|1.04|1.72|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup W, one month after first vaccination.||1.72|1.04|
71027999|NCT03587207|141562874|OTHER|Serogroup Y- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.98|||||TWO_SIDED|80.0|0.7|1.38|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup Y, one month after first vaccination.||1.38|0.70|
71028000|NCT03587207|141562874|OTHER|M14459 strain-Between group ratio for comparison of rMenBOMV\_ACWY\_S group and rMenBOMV group.|Geometric mean ratio|1.05|||||TWO_SIDED|80.0|0.83|1.32|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B M14459 (fHbp) strain, one month after first vaccination.||1.32|0.83|
71028001|NCT03587207|141562874|OTHER|96217 strain-Between group ratio for comparison of rMenBOMV\_ACWY\_S group and rMenBOMV group|Geometric mean ratio|0.8|||||TWO_SIDED|80.0|0.64|1.0|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after first vaccination.||1.00|0.64|
70936146|NCT00749944|141372993|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.43|||||TWO_SIDED|95.0|-0.19|1.05||||||Period AE: Difference varenicline versus placebo.||1.05|-0.19|
70936147|NCT00749944|141372993|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.48|||||TWO_SIDED|95.0|-0.09|1.05||||||Period BC: Difference varenicline versus placebo.||1.05|-0.09|
70936148|NCT00749944|141372993|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.39|||||TWO_SIDED|95.0|-0.28|1.06||||||Period BD: Difference varenicline versus placebo.||1.06|-0.28|
70936149|NCT00749944|141372993|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.09|||||TWO_SIDED|95.0|-0.47|0.65||||||Period BE: Difference varenicline versus placebo.||0.65|-0.47|
71028002|NCT03587207|141562874|OTHER|NZ98/254 strain -Between group ratio for comparison of rMenBOMV\_ACWY\_S group and rMenBOMV group|Geometric mean ratio|0.88|||||TWO_SIDED|80.0|0.69|1.13|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after first vaccination.||1.13|0.69|
71028003|NCT03587207|141562874|OTHER|M07-0241084 strain -Between group ratio for comparison of rMenBOMV\_ACWY\_S group and rMenBOMV group|Geometric mean ratio|0.95|||||TWO_SIDED|80.0|0.76|1.19|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after first vaccination.||1.19|0.76|
71028004|NCT03587207|141562874|OTHER|M14459 strain -Between group ratio for comparison of rMenBOMV\_ACWY\_D group and rMenBOMV group|Geometric mean ratio|0.81|||||TWO_SIDED|80.0|0.64|1.03|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B M14459 (fHbp) strain, one month after first vaccination.||1.03|0.64|
70936150|NCT00749944|141372994|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.85|||||TWO_SIDED|95.0|-0.02|1.72|||||Mixed Models Analysis included baseline, treatment (t; fixed), subject (random), day (d; fixed), and interaction for t-by-d.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.72|-0.02|
70936151|NCT00749944|141372994|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.85|||||TWO_SIDED|95.0|0.16|1.54|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AC: Difference varenicline versus placebo.||1.54|0.16|
70936152|NCT00749944|141372994|SUPERIORITY_OR_OTHER||Difference (change from baseline)|1.24|||||TWO_SIDED|95.0|0.39|2.08|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AD: Difference varenicline versus placebo.||2.08|0.39|
70936153|NCT00749944|141372994|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.83|||||TWO_SIDED|95.0|0.14|1.52|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AE: Difference varenicline versus placebo.||1.52|0.14|
71028005|NCT03587207|141562874|OTHER|96217 strain -Between group ratio for comparison of rMenBOMV\_ACWY\_D group and rMenBOMV group|Geometric mean ratio|0.87|||||TWO_SIDED|80.0|0.69|1.09|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after first vaccination.||1.09|0.69|
71059952|NCT04471428|141627053|SUPERIORITY||Difference in Response Rates|-1.51||||0.7216|TWO_SIDED|95.0|-8.85|5.84|||Chi-squared, Corrected||95% CIs was computed using the Wald method.|Unstratified Analysis||5.84|-8.85|0.7216
71059953|NCT04471428|141627053|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.47|1.62|||||Odds ratios were estimated by logistic regression. 95% CIs was computed using the Wald method.|Unstratified Analysis||1.62|0.47|
71059954|NCT04471428|141627055|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.27|TWO_SIDED|95.0|0.59|1.16|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis: Stratification factors include histology, and prior NSCLC treatment regimens||1.16|0.59|0.2700
71059955|NCT04471428|141627055|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.3031|TWO_SIDED|95.0|0.6|1.17|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||1.17|0.60|0.3031
71028006|NCT03587207|141562874|OTHER|NZ98/254 strain -Between group ratio for comparison of rMenBOMV\_ACWY\_D group and rMenBOMV group|Geometrical mean ratio|0.87|||||TWO_SIDED|80.0|0.68|1.12|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after first vaccination.||1.12|0.68|
71028007|NCT03587207|141562874|OTHER|M07-0241084 strain-Between group ratio for comparison of rMenBOMV\_ACWY\_D group and rMenBOMV group|Geometrical mean ratio|0.88|||||TWO_SIDED|80.0|0.7|1.1|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after first vaccination.||1.10|0.70|
71028008|NCT03587207|141562874|OTHER|M14459 strain-Between group ratio for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.91|||||TWO_SIDED|80.0|0.71|1.15|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B M14459 (fHbp)strain, one month after first vaccination.||1.15|0.71|
71028009|NCT03587207|141562874|OTHER|96217 strain-Between group ratio for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.58|||||TWO_SIDED|80.0|0.47|0.73|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after first vaccination.||0.73|0.47|
71028010|NCT03587207|141562874|OTHER|NZ98/254 strain-Between group ratio for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.69|||||TWO_SIDED|80.0|0.54|0.89|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after first vaccination.||0.89|0.54|
70936154|NCT00749944|141372994|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.52|||||TWO_SIDED|95.0|-0.06|1.09|||||Mixed Models Analysis included baseline, t (fixed), subject (random), time (fixed), d (fixed), and interactions for t-by-time, t-by-d, time-by-d and t-by-time-by-d.|Period BC: Difference varenicline versus placebo.||1.09|-0.06|
70936155|NCT00749944|141372994|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.88|||||TWO_SIDED|95.0|0.05|1.7|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BD: Difference varenicline versus placebo.||1.70|0.05|
70936156|NCT00749944|141372994|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.38|||||TWO_SIDED|95.0|-0.12|0.88|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BE: Difference varenicline versus placebo.||0.88|-0.12|
70936157|NCT00749944|141372995|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.82|||||TWO_SIDED|95.0|-3.07|1.43|||||Mixed Models Analysis included baseline, treatment (t; fixed), subject (random), day (d; fixed), and interaction for t-by-d.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.43|-3.07|
70936158|NCT00749944|141372995|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.19|||||TWO_SIDED|95.0|-2.47|2.08|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AC: Difference varenicline versus placebo.||2.08|-2.47|
70936159|NCT00749944|141372995|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-2.15|||||TWO_SIDED|95.0|-5.19|0.89|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AD: Difference varenicline versus placebo.||0.89|-5.19|
70936160|NCT00749944|141372995|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.98|||||TWO_SIDED|95.0|-3.67|1.7|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AE: Difference varenicline versus placebo.||1.70|-3.67|
70936161|NCT00749944|141372995|SUPERIORITY_OR_OTHER||Difference (change from baseline)|1.95|||||TWO_SIDED|95.0|-0.36|4.26|||||Mixed Models Analysis included baseline, t (fixed), subject (random), time (fixed), d (fixed), and interactions for t-by-time, t-by-d, time-by-d and t-by-time-by-d.|Period BC: Difference varenicline versus placebo.||4.26|-0.36|
70936162|NCT00749944|141372995|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.01|||||TWO_SIDED|95.0|-3.32|3.3|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BD: Difference varenicline versus placebo.||3.30|-3.32|
70936163|NCT00749944|141372995|SUPERIORITY_OR_OTHER||Difference (change from baseline)|1.09|||||TWO_SIDED|95.0|-1.8|3.97|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BE: Difference varenicline versus placebo.||3.97|-1.80|
71028011|NCT03587207|141562874|OTHER|M07-0241084 strain-Between group ratio for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.82|||||TWO_SIDED|80.0|0.65|1.03|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after first vaccination.||1.03|0.65|
71028012|NCT00966953|141562889|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71078005|NCT02081014|141664549|SUPERIORITY_OR_OTHER||Point estimate ratio|0.96|STANDARD_ERROR_OF_MEAN|0.13|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
71078006|NCT02081014|141664550|SUPERIORITY_OR_OTHER||Point estimate ratio|0.82|STANDARD_ERROR_OF_MEAN|0.06|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
71078007|NCT02081014|141664550|SUPERIORITY_OR_OTHER||Point estimate ratio|0.7|STANDARD_ERROR_OF_MEAN|0.05|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
71078008|NCT02081014|141664550|SUPERIORITY_OR_OTHER||Point estimate ratio|0.85|STANDARD_ERROR_OF_MEAN|0.06|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
71078009|NCT02081014|141664551|SUPERIORITY_OR_OTHER||Point estimate ratio|0.96|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
71028013|NCT02799602|141562906|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|0.675|||<|0.0001|TWO_SIDED|95.0|0.568|0.801||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.801|0.568|<0.0001
71028014|NCT02799602|141562909|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|0.357|||<|0.0001|TWO_SIDED|95.0|0.302|0.421||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.421|0.302|<0.0001
71028015|NCT02799602|141562911|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|0.792||||0.0058|TWO_SIDED|95.0|0.66|0.95||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.950|0.660|0.0058
71028016|NCT02799602|141562913|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|0.609|||<|0.0001|TWO_SIDED|95.0|0.516|0.718||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.718|0.516|<0.0001
71109587|NCT02722408|141724367|OTHER|||||||0.0317||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0317
70936164|NCT00749944|141372996|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.52|||||TWO_SIDED|95.0|-0.29|1.32|||||Mixed Models Analysis included baseline, treatment (t; fixed), subject (random), day (d; fixed), and interaction for t-by-d.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.32|-0.29|
70936165|NCT00749944|141372996|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.54|||||TWO_SIDED|95.0|-0.17|1.25|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AC: Difference varenicline versus placebo.||1.25|-0.17|
70936166|NCT00749944|141372996|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.18|||||TWO_SIDED|95.0|-0.55|0.92|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AD: Difference varenicline versus placebo.||0.92|-0.55|
70936167|NCT00749944|141372996|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.26|||||TWO_SIDED|95.0|-0.46|0.99|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AE: Difference varenicline versus placebo.||0.99|-0.46|
70936168|NCT00749944|141372996|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.59|||||TWO_SIDED|95.0|-0.19|1.37|||||Mixed Models Analysis included baseline, t (fixed), subject (random), time (fixed), d (fixed), and interactions for t-by-time, t-by-d, time-by-d and t-by-time-by-d.|Period BC: Difference varenicline versus placebo.||1.37|-0.19|
70936169|NCT00749944|141372996|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.08|||||TWO_SIDED|95.0|-0.91|0.76|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BD: Difference varenicline versus placebo.||0.76|-0.91|
70936170|NCT00749944|141372996|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.1|||||TWO_SIDED|95.0|-0.65|0.85|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BE: Difference varenicline versus placebo.||0.85|-0.65|
70936171|NCT00749944|141372997|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.23|||||TWO_SIDED|95.0|-0.2|0.65|||||Mixed Models Analysis included baseline, treatment (t; fixed), subject (random), day (d; fixed), and interaction for t-by-d.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.65|-0.20|
70936172|NCT00749944|141372997|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.21|||||TWO_SIDED|95.0|-0.17|0.58|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AC: Difference varenicline versus placebo.||0.58|-0.17|
70936173|NCT00749944|141372997|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.21|||||TWO_SIDED|95.0|-0.23|0.65|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AD: Difference varenicline versus placebo.||0.65|-0.23|
70936174|NCT00749944|141372997|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.02|||||TWO_SIDED|95.0|-0.37|0.41|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AE: Difference varenicline versus placebo.||0.41|-0.37|
71109588|NCT02722408|141724367|OTHER|||||||0.0473||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH).||||0.0473
70936175|NCT00749944|141372997|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.09|||||TWO_SIDED|95.0|-0.41|0.59|||||Mixed Models Analysis included baseline, t (fixed), subject (random), time (fixed), d (fixed), and interactions for t-by-time, t-by-d, time-by-d and t-by-time-by-d.|Period BC: Difference varenicline versus placebo.||0.59|-0.41|
70936176|NCT00749944|141372997|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.1|||||TWO_SIDED|95.0|-0.44|0.63|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BD: Difference varenicline versus placebo.||0.63|-0.44|
71028017|NCT02799602|141562915|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|0.712||||0.0081|TWO_SIDED|95.0|0.539|0.94||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.940|0.539|0.0081
71028018|NCT02799602|141562917|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio, log|0.388|||<|0.0001|TWO_SIDED|95.0|0.328|0.458||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.458|0.328|<0.0001
71028019|NCT02799602|141562919|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|1.043||||0.7073|TWO_SIDED|95.0|0.894|1.217||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|1.217|0.894|0.7073
71059956|NCT04471428|141627056|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.2408|TWO_SIDED|95.0|0.86|1.79|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratification factors include histology, and prior NSCLC treatment regimens||1.79|0.86|0.2408
71059957|NCT04471428|141627056|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.1992|TWO_SIDED|95.0|0.88|1.81|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||1.81|0.88|0.1992
71059958|NCT04471428|141627057|SUPERIORITY||Difference in Event Free Rate|15.85||||0.0014|TWO_SIDED|95.0|6.12|25.59|||z-test||The 95% CI for the difference in PFS rates were estimated using the normal approximation method, with standard errors computed using the Greenwood method.|At 6 months||25.59|6.12|0.0014
71059959|NCT04471428|141627057|SUPERIORITY||Difference in Event Free Rate|6.32||||0.0719|TWO_SIDED|95.0|-0.56|13.21|||z-test||The 95% CI for the difference in PFS rates were estimated using the normal approximation method, with standard errors computed using the Greenwood method.|At 1 year||13.21|-0.56|0.0719
70936177|NCT00749944|141372997|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.12|||||TWO_SIDED|95.0|-0.58|0.34|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BE: Difference varenicline versus placebo.||0.34|-0.58|
70936178|NCT00749944|141372998|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.22|||||TWO_SIDED|95.0|-0.66|1.1|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.10|-0.66|
70936179|NCT00749944|141372998|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.44|||||TWO_SIDED|95.0|-0.46|1.35|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||1.35|-0.46|
70936180|NCT00749944|141372998|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.22|||||TWO_SIDED|95.0|-1.16|0.71|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.71|-1.16|
70936181|NCT00749944|141372998|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.03|||||TWO_SIDED|95.0|-0.68|0.73|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.73|-0.68|
71059960|NCT04471428|141627058|SUPERIORITY||Difference in Event Free Rate|-0.85||||0.8767|TWO_SIDED|95.0|-11.63|9.92|||z-test||The 95% CI for the difference in OS rates were estimated using the normal approximation method, with standard errors computed using the Greenwood method.|At 1 year||9.92|-11.63|0.8767
71059961|NCT01870778|141627072|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.3857|TWO_SIDED|95.0|0.83|1.15||Adjusted alpha p-value based on multiple testing procedure.|Log Rank|One-sided p-value||||1.15|0.83|0.3857
70936182|NCT00749944|141372998|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.58|||||TWO_SIDED|95.0|-0.79|1.96|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||1.96|-0.79|
70936183|NCT00749944|141372998|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.43|||||TWO_SIDED|95.0|-1.69|0.82|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.82|-1.69|
70936184|NCT00749944|141372998|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.09|||||TWO_SIDED|95.0|-0.86|0.68|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.68|-0.86|
71028020|NCT02799602|141562921|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|0.688||||0.0037|TWO_SIDED|95.0|0.523|0.906||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.906|0.523|0.0037
71028021|NCT01734772|141562923|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|geometric Mean Ratio|149.38|STANDARD_DEVIATION|37.6||0.9456||90.0|124.388|179.383||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.|||179.383|124.388|0.9456
71028022|NCT01734772|141562923|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|geometric Mean Ratio|126.47|STANDARD_DEVIATION|33.3||0.5481||90.0|107.363|148.967||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.|||148.967|107.363|0.5481
71028023|NCT01734772|141562923|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|geometric Mean Ratio|127.01|STANDARD_DEVIATION|31.6||0.5665||90.0|108.047|149.295||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.|||149.295|108.047|0.5665
70936185|NCT00749944|141372999|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.27|||||TWO_SIDED|95.0|-0.55|1.08|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.08|-0.55|
70936186|NCT00749944|141372999|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.53|||||TWO_SIDED|95.0|-0.39|1.46|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||1.46|-0.39|
70936187|NCT00749944|141372999|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.09|||||TWO_SIDED|95.0|-1.08|1.25|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||1.25|-1.08|
70936188|NCT00749944|141372999|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.14|||||TWO_SIDED|95.0|-0.62|0.9|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.90|-0.62|
71059962|NCT01870778|141627073|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.0968|TWO_SIDED|95.0|0.75|1.07||Adjusted p-value based on multiple testing procedure|Gehan's generalized Wilcoxon test|One-sided p-value||||1.07|0.75|0.0968
71028024|NCT01734772|141562924|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|geometric Mean Ratio|164.74|STANDARD_DEVIATION|42.9||0.9841||90.0|133.945|202.619||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.|||202.619|133.945|0.9841
71028025|NCT01734772|141562924|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|geometric Mean Ratio|128.61|STANDARD_DEVIATION|39.0||0.6003||90.0|106.37|155.495||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.|||155.495|106.370|0.6003
71028026|NCT01734772|141562924|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|gMean Ratio|123.82|STANDARD_DEVIATION|36.9||0.4656||90.0|102.695|149.288||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.|||149.288|102.695|0.4656
70852298|NCT03060551|141193177|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.656||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.656
70936189|NCT00749944|141372999|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.5|||||TWO_SIDED|95.0|-0.94|1.95|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||1.95|-0.94|
70936190|NCT00749944|141372999|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.03|||||TWO_SIDED|95.0|-1.57|1.51|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||1.51|-1.57|
70936191|NCT00749944|141372999|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.08|||||TWO_SIDED|95.0|-0.91|0.75|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.75|-0.91|
70936192|NCT00749944|141373000|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.35|||||TWO_SIDED|95.0|-1.76|1.06|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.06|-1.76|
71059963|NCT01870778|141627074|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.389|TWO_SIDED|95.0|0.81|1.08|||Log Rank|2-sided p-value||||1.08|0.81|0.3890
71059964|NCT01870778|141627075|SUPERIORITY|||||||0.2204||||||Based on multiple testing procedure|Wilcoxon rank sum test|One-sided p-value||||||0.2204
71059965|NCT01870778|141627076|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.2744|TWO_SIDED|95.0|0.88|1.07||Adjusted p-value based on multiple testing procedure|Log Rank|||||1.07|0.88|0.2744
71059966|NCT01870778|141627077|SUPERIORITY|||||||0.2103|||||||Wilcoxon rank sum test|2-sided p-value||||||0.2103
71059967|NCT01870778|141627078|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.005|TWO_SIDED|95.0|1.02|1.14|||Log Rank|2-sided p-value||Exertional dyspnea||1.14|1.02|0.0050
71059968|NCT01870778|141627078|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.0051|TWO_SIDED|95.0|1.02|1.14|||Log Rank|2-sided p-value||Orthopnea||1.14|1.02|0.0051
71059969|NCT01870778|141627078|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9962|TWO_SIDED|95.0|0.95|1.05|||Log Rank|2-sided p-value||Rales||1.05|0.95|0.9962
71059970|NCT01870778|141627078|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.0196|TWO_SIDED|95.0|1.01|1.15|||Log Rank|2-sided p-value||Jugular venous pressure||1.15|1.01|0.0196
71059971|NCT01870778|141627078|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.2158|TWO_SIDED|95.0|0.98|1.1|||Log Rank|2-sided p-value||Peripheral edema, pre-sacral edema||1.10|0.98|0.2158
70936193|NCT00749944|141373000|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.11|||||TWO_SIDED|95.0|-0.96|1.17|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||1.17|-0.96|
71059972|NCT01870778|141627079|SUPERIORITY||Ratio of RLX030 to placebo|0.9401||||0.0209|TWO_SIDED|95.0|0.8921|0.9907|||Repeated measures model|||Day 2||0.9907|0.8921|0.0209
71059973|NCT01870778|141627079|SUPERIORITY||Ratio of RLX030 to placebo|0.898||||0.0034|TWO_SIDED|95.0|0.8358|0.9649|||Repeated measures model|||Day 5||0.9649|0.8358|0.0034
71059974|NCT01870778|141627079|SUPERIORITY||Ratio of RLX030 to placebo|0.9074||||0.0209|TWO_SIDED|95.0|0.8355|0.9854|||Repeated measures model|||Day 14||0.9854|0.8355|0.0209
71059975|NCT01870778|141627080|SUPERIORITY||Ratio of RLX030 to placebo|0.8597||||0.0007|TWO_SIDED|95.0|0.7876|0.9385|||Repeated measures model|||Day 2||0.9385|0.7876|0.0007
71109589|NCT02722408|141724368|OTHER|||||||0.2143||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.2143
71109590|NCT02722408|141724368|OTHER|||||||0.1874||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.1874
71109591|NCT02722408|141724368|OTHER|||||||0.6731||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.6731
71059976|NCT01870778|141627080|SUPERIORITY||Ratio of RLX030 to placebo|0.9539||||0.3709|TWO_SIDED|95.0|0.86|1.0579|||Repeated measures model|||Day 5||1.0579|0.8600|0.3709
71059977|NCT01870778|141627080|SUPERIORITY||Ratio of RLX030 to placebo|0.9543||||0.3893|TWO_SIDED|95.0|0.8578|1.0617|||Repeated measures model|||Day 14||1.0617|0.8578|0.3893
71059978|NCT01870778|141627081|SUPERIORITY||Ratio of RLX030 to placebo|0.9637||||0.0003|TWO_SIDED|95.0|0.9447|0.983|||Repeated measures model|||Day 2||0.9830|0.9447|0.0003
71059979|NCT01870778|141627081|SUPERIORITY||Ratio of RLX030 to placebo|0.9922||||0.5361|TWO_SIDED|95.0|0.9677|1.0172|||Repeated measures model|||Day 5||1.0172|0.9677|0.5361
71059980|NCT01870778|141627081|SUPERIORITY||Ratio of RLX030 to placebo|0.9863||||0.375|TWO_SIDED|95.0|0.9567|1.0169|||Repeated measures model|||Day 14||1.0169|0.9567|0.3750
71059981|NCT03123068|141627094|OTHER||||||>|0.05|||||||Mann Whitney U test|||||||>0.05
71078010|NCT02081014|141664551|SUPERIORITY_OR_OTHER||Point estimate ratio|0.83|STANDARD_ERROR_OF_MEAN|0.06|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
71078011|NCT02081014|141664551|SUPERIORITY_OR_OTHER||Point estimate ratio|0.86|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
71078012|NCT02081014|141664552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3693.2|STANDARD_ERROR_OF_MEAN|1520.1|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
71078013|NCT02081014|141664552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7548.05|STANDARD_ERROR_OF_MEAN|1542.93||0.05|TWO_SIDED||||||Mixed Models Analysis|||||||0.05
71028027|NCT00329602|141562925|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||P-value is for Week 12.|Repeated Measures Mixed Model|Adjusted for baseline IRLS Rating Scale total score, treatment group, visit, visit by treatment group interaction, and center group.||||||0.039
71028028|NCT00329602|141562925|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value is for Week 26.|Repeated Measures Mixed Model|Adjusted for baseline IRLS Rating Scale total score, treatment group, visit, visit by treatment group interaction, and center group.||||||0.023
71059982|NCT01184079|141627138|NON_INFERIORITY_OR_EQUIVALENCE|"Sample size: (1 + 1/u)(Zα + Zβ)2 σ2 /\[log (RGMT) -δ0\] u= ratio of the size of the Standard schedule to Alternate schedule groups (u =1, for equal size groups); one-sided alpha (0.025)/4 for multiplicity of serotypes. Average log-transformed and geometric mean titers (GMTs) with a two-sided 95% confidence interval of the ratio of the GMTs were used.~Non-inferiority is determined if upper bound GMT ratio of standard group to alternate group \< 1.5."|largest upper bound GMT ratio|0.82|||||||||||||Non-inferiority is determined if upper bound GMT ratio of standard 6 month group to alternate 12 month group \< 1.5.|The primary endpoint would demonstrate noninferiority if the upper bound of the 95% two-sided confidence interval (CI) of the ratio of GMT for Standard schedule group divided by that of Alternate schedule group is \<1.5.||||
71059983|NCT01184079|141627140|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Chi-squared|||null hypothsesis: no difference in proportion of side effects reported between groups||||0.26
71059984|NCT03180645|141627166|OTHER||Least square (LS) mean difference|-1.07||||0.0638|TWO_SIDED|95.0|-2.21|0.06|||ANCOVA|Analysis model (ANCOVA) included participant as random effect, treatment arm and side of the face as fixed effects and baseline value as covariate.|Difference is the first named treatment adjusted (LS) mean change from baseline minus the second named treatment adjusted mean change from baseline.|||0.06|-2.21|0.0638
71059985|NCT01808573|141627178|SUPERIORITY||Hazard Ratio (HR)|0.762||||0.0059|TWO_SIDED|95.0|0.626|0.926|||Log Rank|Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting, and visceral disease vs. non-visceral.|Lapatinib Plus Capecitabine is the reference. Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting, and visceral disease vs. non-visceral.|||0.926|0.626|0.0059
71059986|NCT01808573|141627179|SUPERIORITY||Hazard Ratio (HR)|0.881||||0.2086|TWO_SIDED|95.0|0.723|1.073|||Log Rank|Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting, and visceral disease vs. non-visceral.|Lapatinib plus Capecitabine is the reference. Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting, and visceral disease vs. non-visceral.|||1.073|0.723|0.2086
71059987|NCT01808573|141627180|SUPERIORITY|||||||0.043|||||||Gray's test|Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting and visceral disease vs. non-visceral disease.||||||0.043
71059988|NCT01808573|141627181|SUPERIORITY|||||||0.1201|||||||Cochran-Mantel-Haenszel|Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting and visceral disease vs. non-visceral.||||||0.1201
71059989|NCT01808573|141627182|SUPERIORITY|||||||0.0328|||||||Cochran-Mantel-Haenszel|Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting and visceral disease vs. non-visceral.||||||0.0328
71059990|NCT01808573|141627183|SUPERIORITY||Hazard Ratio (HR)|0.495||||0.0004|TWO_SIDED|95.0|0.332|0.736|||Log Rank||Lapatinib Plus Capecitabine is the reference.|||0.736|0.332|0.0004
71059991|NCT02208089|141627185|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Null hypothesis = TransPRK produced no gains in vision over and above those produced by CXL only||||0.03
71059992|NCT02208089|141627186|SUPERIORITY|||||||0.005|||||||Chi-squared|||Null hypothesis = an equal proportion of patients in both study arms have clinically significant visual gains||||0.005
71028029|NCT01600495|141562940|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Mixed Models Analysis|||||||0.01
71028030|NCT01600495|141562941|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.25
71028031|NCT01600495|141562943|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Fisher Exact|||Fisher's exact test||||<0.01
71028032|NCT02097121|141562944|SUPERIORITY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|1.107|=|0.3802|TWO_SIDED|95.0|-3.203|1.243|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group as factor. A hierarchical analysis strategy to adjust for multiplicity was used."||1.243|-3.203|= 0.3802
71059993|NCT02208089|141627187|NON_INFERIORITY|Non-inferiority = no significant difference between rates of clinically significant visual loss between groups at the p≤0.05 level||||||0.13|||||||Chi-squared|||null hypothesis = rates of clinically significant visual loss are equal for TransPRKCXL and CXL only||||0.13
71059994|NCT00972595|141627220|NON_INFERIORITY_OR_EQUIVALENCE|Study Primary Hypothesis: A single dose of the U.K. ZOFRAN™ (ondansetron) 8 mg tablet over-encapsulated is bioequivalent to a single dose of the U.K. ZOFRAN™ (ondansetron) 8-mg tablet. That is, the true geometric mean ratios (U.K. ZOFRAN™ tablet over-encapsulated/U.K. ZOFRAN™ tablet) of AUC0-∞ and Cmax for ondansetron each lie within the interval 0.80 to 1.25.|Least-Squares Mean Ratio|0.98||||||90.0|0.93|1.03||||||Least-Squares Mean Ratio (OE U.K. tablet / U.K. tablet): an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally; a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally||1.03|0.93|
71078014|NCT02081014|141664552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3854.86|STANDARD_ERROR_OF_MEAN|1533.95|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
71078015|NCT02081014|141664553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-144.9|STANDARD_ERROR_OF_MEAN|741.24|>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>0.05
71078016|NCT02081014|141664553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1665.32|STANDARD_ERROR_OF_MEAN|696.97|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
71078017|NCT02081014|141664553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1520.39|STANDARD_ERROR_OF_MEAN|700.92|>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>0.05
71078018|NCT02081014|141664554|SUPERIORITY_OR_OTHER||Point estimate ratio|0.41|STANDARD_ERROR_OF_MEAN|0.32|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
71078019|NCT02081014|141664554|SUPERIORITY_OR_OTHER||Point estimate ratio|0.43|STANDARD_ERROR_OF_MEAN|0.34|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
71078020|NCT02081014|141664554|SUPERIORITY_OR_OTHER||Point estimate ratio|1.05|STANDARD_ERROR_OF_MEAN|0.81|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
70936194|NCT00749944|141373000|SUPERIORITY_OR_OTHER||Difference (change from baseline)|1.49|||||TWO_SIDED|95.0|-1.94|4.91|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||4.91|-1.94|
71028033|NCT02097121|141562944|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.154|=|0.733|TWO_SIDED|95.0|-1.921|2.712|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group as factor. A hierarchical analysis strategy to adjust for multiplicity was used."||2.712|-1.921|= 0.733
71028034|NCT02097121|141562945|SUPERIORITY||LS Mean Difference|0.82|STANDARD_ERROR_OF_MEAN|1.442|=|0.5743|TWO_SIDED|95.0|-2.082|3.713|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||3.713|-2.082|= 0.5743
71028035|NCT02097121|141562945|SUPERIORITY||LS Mean Difference|2.15|STANDARD_ERROR_OF_MEAN|1.455|=|0.1451|TWO_SIDED|95.0|-0.769|5.078|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||5.078|-0.769|= 0.1451
71028036|NCT02097121|141562946|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|1.434|=|0.8206|TWO_SIDED|95.0|-3.205|2.551|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||2.551|-3.205|= 0.8206
71028037|NCT02097121|141562946|SUPERIORITY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|1.434|=|0.9604|TWO_SIDED|95.0|-2.807|2.95|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||2.95|-2.807|= 0.9604
71028038|NCT02097121|141562948|SUPERIORITY||LS Mean Difference|35.33|STANDARD_ERROR_OF_MEAN|22.175|=|0.1174|TWO_SIDED|95.0|-9.207|79.873|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||79.873|-9.207|= 0.1174
71028039|NCT02097121|141562948|SUPERIORITY||LS Mean Difference|34.11|STANDARD_ERROR_OF_MEAN|23.722|=|0.1567|TWO_SIDED|95.0|-13.536|81.76|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||81.76|-13.536|= 0.1567
71059995|NCT00972595|141627221|NON_INFERIORITY_OR_EQUIVALENCE|Study Primary Hypothesis: A single dose of the U.K. ZOFRAN™ (ondansetron) 8 mg tablet over-encapsulated is bioequivalent to a single dose of the U.K. ZOFRAN™ (ondansetron) 8 mg tablet. That is, the true geometric mean ratios (U.K. ZOFRAN™ tablet over-encapsulated/U.K. ZOFRAN™ tablet) of AUC0-∞ and Cmax for ondansetron each lie within the interval 0.80 to 1.25.|Least-Squares Mean Ratio|0.99||||||90.0|0.93|1.05||||||"Least-Squares Mean Ratio (OE U.K. tablet / U.K. tablet): an over-encapsulated single 8 mg tablet of United Kingdom~(U.K.) ZOFRAN™ (ondansetron) taken orally; a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the~United Kingdom (U.K.) taken orally"||1.05|0.93|
71059996|NCT00141778|141627234|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||Chi-squared|||Discrete variables were compared among treatment groups with a chi-square test.||||0.95
70936195|NCT00749944|141373000|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.5|||||TWO_SIDED|95.0|-1.18|2.18|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||2.18|-1.18|
71028040|NCT02097121|141562949|SUPERIORITY||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|4.091|=|0.7481|TWO_SIDED|95.0|-9.553|6.909|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||6.909|-9.553|= 0.7481
71028041|NCT02097121|141562949|SUPERIORITY||LS Mean Difference|1.85|STANDARD_ERROR_OF_MEAN|4.299|=|0.6691|TWO_SIDED|95.0|-6.799|10.498|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||10.498|-6.799|= 0.6691
71059997|NCT00141778|141627235|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Chi-squared|||||||0.006
71059998|NCT00141778|141627236|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||Chi-squared|||||||0.15
71059999|NCT00141778|141627237|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Chi-squared|||||||0.14
71060000|NCT00141778|141627238|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Kruskal-Wallis|||||||0.56
71028042|NCT02097121|141562950|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.343|=|0.9297|TWO_SIDED|95.0|-0.721|0.661|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||0.661|-0.721|= 0.9297
71028043|NCT02097121|141562950|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.357|=|0.3976|TWO_SIDED|95.0|-1.022|0.413|||ANCOVA|||Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented.||0.413|-1.022|= 0.3976
71028044|NCT02097121|141562951|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.302|=|0.3309|TWO_SIDED|95.0|-0.311|0.904|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||0.904|-0.311|= 0.3309
71028045|NCT02097121|141562951|SUPERIORITY||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.315|=|0.2235|TWO_SIDED|95.0|-0.245|1.024|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||1.024|-0.245|= 0.2235
71028046|NCT02097121|141562952|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.274|=|0.6689|TWO_SIDED|95.0|-0.434|0.67|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||0.67|-0.434|= 0.6689
71028047|NCT02097121|141562952|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.288|=|0.6076|TWO_SIDED|95.0|-0.431|0.729|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||0.729|-0.431|= 0.6076
71028048|NCT02097121|141562953|SUPERIORITY||Risk difference %|15.5|||=|0.6092|TWO_SIDED|95.0|-18.94|46.19|||Cochran-Mantel-Haenszel|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using the Cochran-Mantel-Haenszel (CMH) method stratified by baseline daytime urinary urgency incontinence episodes (a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period)."||46.19|-18.94|= 0.6092
71028049|NCT02097121|141562953|SUPERIORITY||Risk difference %|17.6|||=|0.4824|TWO_SIDED|95.0|-16.2|48.9|||Cochran-Mantel-Haenszel|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using the Cochran-Mantel-Haenszel (CMH) method stratified by baseline daytime urinary urgency incontinence episodes (a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period)."||48.9|-16.2|= 0.4824
70936196|NCT00749944|141373000|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.61|||||TWO_SIDED|95.0|-0.85|2.07|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||2.07|-0.85|
71028050|NCT00661999|141562957|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||Fisher Exact|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 15% in the primary hematopoietic response endpoint through Fisher's exact test, if the true percentage of patients that experience a hematopoietic response was at least 30% in the superior group, with a 2.5% type I error rate.||||0.39
71028051|NCT00661999|141562957|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Fisher Exact|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 15% in the primary hematopoietic response endpoint through Fisher's exact test, if the true percentage of patients that experience a hematopoietic response was at least 30% in the superior group, with a 2.5% type I error rate.||||0.73
71028052|NCT00661999|141562959|SUPERIORITY_OR_OTHER|||||||0.725||95.0|||||Fisher Exact|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 15% in the true percentage of patients that need transfusion was at least 30% in the superior group, with a 2.5% type I error rate.||||0.7250
71060001|NCT00141778|141627239|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||Kruskal-Wallis|||||||0.15
71060002|NCT00141778|141627240|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||Chi-squared|||||||0.38
71060003|NCT00141778|141627241|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Chi-squared|||||||0.65
71060004|NCT02729909|141627245|SUPERIORITY||Median Value of confidence interval (CI)|1.0||||0.02|TWO_SIDED|95.0|0.1|1.9||Spontaneous bowel movement was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||||1.9|0.1|0.020
71060005|NCT02729909|141627246|SUPERIORITY||Median Value of CI|1.0||||0.051|TWO_SIDED|95.0|0.0|1.9||Spontaneous bowel movement was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 2||1.9|0.0|0.051
71078021|NCT02081014|141664555|SUPERIORITY_OR_OTHER||Point estimate ratio|0.23|STANDARD_ERROR_OF_MEAN|0.29|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
71028053|NCT00661999|141562959|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Fisher Exact|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 15% in the true percentage of patients that need transfusion was at least 30% in the superior group, with a 2.5% type I error rate.||||0.8700
71028054|NCT00661999|141562960|SUPERIORITY_OR_OTHER|||||||0.6639||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in average hemoglobin levels through two-sided alternative, with a 2.5% type I error rate.||||0.6639
71028055|NCT00661999|141562960|SUPERIORITY_OR_OTHER|||||||0.566||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in average hemoglobin levels through two-sided alternative, with a 2.5% type I error rate.||||0.5660
71028056|NCT00661999|141562961|SUPERIORITY_OR_OTHER|||||||0.1124||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in average hemoglobin levels through two-sided alternative, with a 2.5% type I error rate.||||0.1124
71028057|NCT00661999|141562961|SUPERIORITY_OR_OTHER|||||||0.2051||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in average hemoglobin levels through two-sided alternative, with a 2.5% type I error rate.||||0.2051
71028058|NCT00661999|141562962|SUPERIORITY_OR_OTHER|||||||0.0648||95.0|||||Log Rank|||||||0.0648
71028059|NCT00661999|141562964|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.61
71109592|NCT02722408|141724368|OTHER|||||||0.0027||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.0027
71028060|NCT00661999|141562964|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.44
71109593|NCT02722408|141724368|OTHER|||||||0.002||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.0020
71109594|NCT02722408|141724368|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||<0.0001
71028061|NCT00661999|141562965|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.62
71028062|NCT00661999|141562965|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.30
71028063|NCT00661999|141562966|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.19
71028064|NCT00661999|141562966|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.17
71028065|NCT00661999|141562967|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.73
71109595|NCT02722408|141724368|OTHER|||||||0.0258||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0258
71109596|NCT02722408|141724368|OTHER|||||||0.0044||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.0044
71028066|NCT00661999|141562967|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.83
71028067|NCT00661999|141562968|SUPERIORITY_OR_OTHER|||||||0.3852||95.0||||Test Comparison for Week 1 Level|Kruskal-Wallis|||||||0.3852
71028068|NCT00661999|141562968|SUPERIORITY_OR_OTHER|||||||0.0663||95.0||||Test Comparison for Week 7 Level.|Kruskal-Wallis|||||||0.0663
71028069|NCT00661999|141562968|SUPERIORITY_OR_OTHER|||||||0.322||95.0||||Test Comparison for Week 16 Level|Kruskal-Wallis|||||||0.3220
71028070|NCT00661999|141562969|SUPERIORITY_OR_OTHER|||||||0.1826||95.0||||Test Comparison for Week 1 Level.|Kruskal-Wallis|||||||0.1826
71028071|NCT00661999|141562969|SUPERIORITY_OR_OTHER|||||||0.0113||95.0||||Test comparison for week 7 level|Kruskal-Wallis|||||||0.0113
71028072|NCT00661999|141562969|SUPERIORITY_OR_OTHER|||||||0.3358||95.0||||Test Comparison for week 16 level|Kruskal-Wallis|||||||0.3358
71028073|NCT00661999|141562970|SUPERIORITY_OR_OTHER|||||||0.9022||95.0||||Test comparison for Baseline level.|Kruskal-Wallis|||||||0.9022
71109597|NCT02722408|141724368|OTHER|||||||0.0011||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0011
71028074|NCT00661999|141562970|SUPERIORITY_OR_OTHER|||||||0.0002||95.0||||Test Comparison for Week 7 Level.|Kruskal-Wallis|||||||0.0002
71028075|NCT00661999|141562970|SUPERIORITY_OR_OTHER|||||||0.0022||95.0||||Test Comparison for Week 16 Level.|Kruskal-Wallis|||||||0.0022
71028076|NCT00661999|141562971|SUPERIORITY_OR_OTHER|||||||0.1137||95.0||||Test comparison for baseline level.|Kruskal-Wallis|||||||0.1137
71028077|NCT00661999|141562971|SUPERIORITY_OR_OTHER|||||||0.8042||95.0||||Test comparison for week 7 level.|Kruskal-Wallis|||||||0.8042
71028078|NCT00661999|141562971|SUPERIORITY_OR_OTHER|||||||0.2016||95.0||||Test comparison for week 16 level.|Kruskal-Wallis|||||||0.2016
71028079|NCT00661999|141562972|SUPERIORITY_OR_OTHER|||||||0.1139||95.0||||Test comparison for baseline level.|Kruskal-Wallis|||||||0.1139
71028080|NCT00661999|141562972|SUPERIORITY_OR_OTHER|||||||0.0424||95.0||||Test comparison for week 7 level.|Kruskal-Wallis|||||||0.0424
71028081|NCT00661999|141562972|SUPERIORITY_OR_OTHER|||||||0.2025||95.0||||Test comparison for week 16 level.|Kruskal-Wallis|||||||0.2025
71028082|NCT03708211|141563027|OTHER||Ratio of geometric mean|0.9359|||||TWO_SIDED|90.0|0.8084|1.0835||||||Following log-transformation, PK parameters were analyzed by analysis of variance (ANOVA) fitting terms for treatment group, sequence and period. Participants within sequence were treated as a random effect. The obtained point estimates and adjusted 90 percent (%) confidence intervals (CIs) for difference in treatment were exponentially back transformed to provide point and confidence interval estimates for the ratios of interest appropriately.||1.0835|0.8084|
71028083|NCT03708211|141563028|OTHER||Ratio of geometric mean|1.0036|||||TWO_SIDED|90.0|0.8992|1.1201||||||Following log-transformation, PK parameters were analyzed by ANOVA fitting terms for treatment group, sequence and period. Participants within sequence were treated as a random effect. The obtained point estimates and adjusted 90% CIs for difference in treatment were exponentially back transformed to provide point and confidence interval estimates for the ratios of interest appropriately.||1.1201|0.8992|
71028084|NCT03708211|141563029|OTHER||Ratio of geometric mean|1.0071|||||TWO_SIDED|90.0|0.9033|1.1227||||||Following log-transformation, PK parameters were analyzed by ANOVA fitting terms for treatment group, sequence and period. Participants within sequence were treated as a random effect. The obtained point estimates and adjusted 90% CIs for difference in treatment were exponentially back transformed to provide point and confidence interval estimates for the ratios of interest appropriately.||1.1227|0.9033|
71028085|NCT01508936|141563040|SUPERIORITY_OR_OTHER||slope difference|0.3007|STANDARD_ERROR_OF_MEAN|0.2559||0.2407|TWO_SIDED|||||The interaction was tested at the significance level 0.10 using the FAS|Regression, Linear||Active - Placebo|The primary analysis was the linear regression model with model effects including treatment (reslizumab or placebo), blood eosinophil count at baseline, and the interaction of treatment and eosinophil count. A significant treatment by baseline eosinophil interaction would indicate that treatment difference varies by the baseline eosinophil count.||||0.2407
71028086|NCT01508936|141563041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.076|STANDARD_ERROR_OF_MEAN|0.0417||0.0697|TWO_SIDED|95.0|-0.006|0.158||Statistical significance level is 0.05.|Regression, Linear|treatment, blood eosinophil count at baseline, and the interaction of treatment and eosinophil count as fixed effects.|Active - Placebo|"The change from baseline over the 16 week treatment period was measured for the key secondary variables of:~* Lung function as measured by FEV1~* ACQ~Testing of the key secondary variables was performed using the sequential testing procedure in the order as specified above at the alpha level of 0.05."||0.158|-0.006|0.0697
71028087|NCT01508936|141563042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.123|STANDARD_ERROR_OF_MEAN|0.0762||0.1072|TWO_SIDED|95.0|-0.273|0.027||significance level of 0.05|t-test, 2 sided|Fixed effects for treatment, hx of asthma exacerbation, sex, visit, and interaction of treatment and visit; covariates for height and baseline value|Active - Placebo|"The change from baseline over the 16 week treatment period was measured for the key secondary variables of:~* Lung function as measured by FEV1~* ACQ~Testing of the key secondary variables was performed using the sequential testing procedure in the order as specified above at the alpha level of 0.05."||0.027|-0.273|0.1072
71109598|NCT02722408|141724368|OTHER|||||||0.0083||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0083
71109599|NCT02722408|141724368|OTHER|||||||0.0314||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0314
71109600|NCT02722408|141724368|OTHER|||||||0.0533||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0533
71028088|NCT00770315|141563082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76||||0.2192|TWO_SIDED|95.0|-1.98|0.45|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.45|-1.98|0.2192
71028089|NCT00770315|141563082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.58||||0.0113|TWO_SIDED|95.0|-2.8|-0.36|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.36|-2.80|0.0113
71028090|NCT00770315|141563082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04||||0.0015|TWO_SIDED|95.0|-3.3|-0.79|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.79|-3.30|0.0015
71028091|NCT00770315|141563083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88||||0.0878|TWO_SIDED|95.0|-1.88|0.13|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.13|-1.88|0.0878
71028092|NCT00770315|141563083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.0125|TWO_SIDED|95.0|-2.29|-0.28|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.28|-2.29|0.0125
71028093|NCT00770315|141563083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.92||||0.0003|TWO_SIDED|95.0|-2.95|-0.88|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.88|-2.95|0.0003
71028094|NCT00770315|141563084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.4781|TWO_SIDED|95.0|-0.96|0.45|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.45|-0.96|0.4781
71028095|NCT00770315|141563084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.1695|TWO_SIDED|95.0|-1.21|0.21|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.21|-1.21|0.1695
70852299|NCT03060551|141193178|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.096||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.096
70936197|NCT00749944|141373000|SUPERIORITY_OR_OTHER||Difference (change from baseline)|2.1|||||TWO_SIDED|95.0|-2.6|6.79|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||6.79|-2.60|
70936198|NCT00749944|141373000|SUPERIORITY_OR_OTHER||Difference (change from baseline)|1.13|||||TWO_SIDED|95.0|-0.7|2.96|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||2.96|-0.70|
71028096|NCT00770315|141563084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94||||0.0118|TWO_SIDED|95.0|-1.67|-0.21|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.21|-1.67|0.0118
71028097|NCT00770315|141563085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.2622|TWO_SIDED|95.0|-0.93|0.25|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.25|-0.93|0.2622
71028098|NCT00770315|141563085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.1914|TWO_SIDED|95.0|-0.99|0.2|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.20|-0.99|0.1914
71028099|NCT00770315|141563085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96||||0.0021|TWO_SIDED|95.0|-1.57|-0.35|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.35|-1.57|0.0021
71028100|NCT00770315|141563086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.19|TWO_SIDED|95.0|-1.26|0.25|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.25|-1.26|0.1900
71028101|NCT00770315|141563086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.0053|TWO_SIDED|95.0|-1.84|-0.32|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.32|-1.84|0.0053
71028102|NCT00770315|141563086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.0058|TWO_SIDED|95.0|-1.89|-0.32|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.32|-1.89|0.0058
71028103|NCT02683187|141563087|EQUIVALENCE|Insulin secretion, determined by insulin or C-peptide values in the 10 minutes after arginine infusion will be compared as a repeated measure for each subject in a 2 x 2 analysis of sitagliptin/placebo and Exendin-9/saline.|Median Difference (Final Values)|371.0|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||< 0.05
71028104|NCT02585258|141563088|SUPERIORITY||mean difference over 2-years|-0.37|||<|0.0001|ONE_SIDED|95.0||-0.23||one-sided.|Mixed Models Analysis||placebo is reference. Negative difference is beneficial, means lower disease activity in prednisolone group.|mixed model reports the effect of treatment, adjusted for stratification factors||-0.23||<0.0001
71028105|NCT02585258|141563089|SUPERIORITY||Risk Ratio (RR)|1.24||||0.02|ONE_SIDED|95.0|1.04|||one-sided|GEE||prednisolone/placebo|mixed model reports the effect of treatment, adjusted for stratification factors|||1.04|0.02
71028106|NCT02585258|141563090|SUPERIORITY||mean differences over 2 years|-1.67||||0.003|ONE_SIDED|95.0||-0.68||one-sided|Regression, Linear||placebo is reference. Negative difference means less damage progression in prednisolone group.|mixed model reports the effect of treatment, adjusted for stratification factors||-0.68||0.003
71028107|NCT04908748|141563091|SUPERIORITY||Least squares mean difference|-29.1|||<|0.0001|TWO_SIDED|95.0|-32.2|-26.0|||ANCOVA|||||-26.0|-32.2|< 0.0001
71028108|NCT03702621|141563107|OTHER|P values are from mixed model least squares (LS) means differences with Sidak adjustment for multiple comparisons.||||||0.54|||||||Mixed Models Analysis|Sidak adjustment||||||0.54
71028109|NCT03702621|141563108|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.59|||||||Mixed Models Analysis|||||||0.59
71028110|NCT03702621|141563109|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons||||||0.98||||||P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons|Mixed Models Analysis|Sidak adjustment||||||0.98
71028111|NCT03702621|141563110|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons||||||0.94||||||P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons|Mixed Models Analysis|Sidak adjustment||||||0.94
71028112|NCT03702621|141563111|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons||||||0.86|||||||Mixed Models Analysis|Sidak adjustment||P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons||||0.86
71028113|NCT03702621|141563112|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons||||||1||||||P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons|Mixed Models Analysis|Sidak adjustment||||||1.0
71028114|NCT03702621|141563113|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.99|||||||Mixed Models Analysis|||||||0.99
71028115|NCT03702621|141563114|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.99|||||||Mixed Models Analysis|||||||0.99
71028116|NCT03702621|141563115|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.72|||||||Mixed Models Analysis|||||||0.72
71028117|NCT03702621|141563116|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.29|||||||Mixed Models Analysis|||||||0.29
71060006|NCT02729909|141627246|SUPERIORITY||Median Value of CI|1.5||||0.003|TWO_SIDED|95.0|1.0|2.0||Spontaneous bowel movement was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 3||2.0|1.0|0.003
71060007|NCT02729909|141627246|SUPERIORITY||Median Value of CI|1.0||||0.009|TWO_SIDED|95.0|0.1|1.9||Spontaneous bowel movement was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 4||1.9|0.1|0.009
71060008|NCT02729909|141627247|SUPERIORITY||Odds Ratio (OR)|2.08||||0.009|TWO_SIDED|95.0|1.19|3.62||The proportion of participants with an SBM within 24 hours after first dose in Week 1 is analyzed by a Cochran-Mantel-Haenszel (CMH) test stratified by center. Centers with less participants were pooled based on geographical proximity.|Cochran-Mantel-Haenszel|||||3.62|1.19|0.009
71060009|NCT02729909|141627248|SUPERIORITY||Median Value of CI|-0.4||||0.001|TWO_SIDED|95.0|-0.6|-0.2||Average Degree of Straining was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 1||-0.2|-0.6|0.001
71109601|NCT02722408|141724369|OTHER|||||||0.3657||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.3657
71028118|NCT03702621|141563117|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.46|||||||Mixed Models Analysis|||||||0.46
71028119|NCT03702621|141563118|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.77|||||||Mixed Models Analysis|||||||0.77
71028120|NCT03194464|141563151|OTHER|||||||0.15||||||The a priori threshold for statistical significance was established at p \<.05 (non-adjusted).|ANOVA|||We performed repeated measures analysis of variance (RM-ANOVA) to determine if intracortical inhibition, as measured by SICI, in the ipsilesional hemisphere was altered by less affected hand exercise to task-failure and to determine the time course and recovery of this effect.||||0.15
71028121|NCT03194464|141563152|SUPERIORITY|||||||0.83||||||Statistical Significance established as p \<.05|ANOVA|Repeated-Measures ANOVA||We performed repeated measures analysis of variance (RM-ANOVA) to determine if intracortical inhibition, as measured by SICI, in the ipsilesional hemisphere was altered by repeated sessions of less affected hand exercise to task-failure. Pre-exercise SICI was compared between Session1 and Session8.||||.83
71028122|NCT03194464|141563153|OTHER|||||||0.204|||||||ANOVA|||RM-ANOVA||||0.204
71028123|NCT03194464|141563154|SUPERIORITY|||||||0.004||||||statistical significance was established a priori at p \<.05|ANOVA|repeated measures ANOVA comparing Session8 vs. Session1 performance||We performed repeated measures analysis of variance (RM-ANOVA) to determine if motor dexterity, as measured by the BBT, was improved by repeated sessions of non-paretic hand exercise to task-failure. BBT performance was compared between Session1 and Session8.||||.004
71028124|NCT02606500|141563159|NON_INFERIORITY|We hypothesized that Elonva 150 mcg is non-inferior for COH in obese women.||||||0.9|||||||Regression, Logistic|||||||0.9
71028125|NCT02606500|141563160|NON_INFERIORITY|We hypothesized that Elonva 150 mcg is non-inferior for COH in obese women.||||||0.5|||||||Regression, Logistic|||||||0.5
71028126|NCT02606500|141563161|NON_INFERIORITY|We hypothesized that Elonva 150 mcg is non-inferior for COH in obese women.||||||0.3|||||||Regression, Logistic|||||||0.3
71028127|NCT02606500|141563162|NON_INFERIORITY|We hypothesized that Elonva 150 mcg is non-inferior for COH in obese women.||||||0.9|||||||Regression, Logistic|||||||0.9
71028128|NCT02606500|141563163|NON_INFERIORITY|We presumed Elonva 150 mcg in obese and normal weighing women yields comparable biochemical pregnancy rates.||||||0.4|||||||Regression, Logistic|||||||0.4
71060010|NCT02729909|141627248|SUPERIORITY||Median Value of CI|-0.3||||0.004|TWO_SIDED|95.0|-0.5|-0.1||Average Degree of Straining was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 2||-0.1|-0.5|0.004
71060011|NCT02729909|141627248|SUPERIORITY||Median Value of CI|-0.2||||0.024|TWO_SIDED|95.0|-0.4|-0.1||Average Degree of Straining was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 3||-0.1|-0.4|0.024
71060012|NCT02729909|141627248|SUPERIORITY||Median Value of CI|-0.3||||0.01|TWO_SIDED|95.0|-0.5|-0.1||Average Degree of Straining was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 4||-0.1|-0.5|0.010
71060013|NCT02729909|141627249|SUPERIORITY||Median Value of CI|0.6|||<|0.001|TWO_SIDED|95.0|0.4|1.0||Mean Degree of Stool Consistency was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 1||1.0|0.4|<0.001
71109602|NCT02722408|141724369|OTHER|||||||0.1983||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.1983
71028129|NCT00810368|141563183|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED|||||2-tailed paired Student's t-tests between Week 0 and Week 12 responses (above) were anticipated to show significant benefits with carnosine treatment but no change with placebo. There were no corrections for multiple comparisons in the reported data.|t-test, 2 sided|Paired t-test||Description of Power Calculation: The planned sample size completing each arm was based on individual incremental improvements in the primary outcomes of : A) CFS Severity Scores (Baraniuk et al., Annals Allergy Astma Immunol, 1998), B) Instantaneous Fatigue (Kim et al. Journal of Rehab Res Dev, 2010), and C) increased accuracy of 4/35 letters for 2 back working memory task (Owen, Human Brain Mapping, 2005).||||0.30
70936199|NCT00749944|141373001|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.0|||||TWO_SIDED|95.0|-0.26|0.27|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.27|-0.26|
70936200|NCT00749944|141373001|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.02|||||TWO_SIDED|95.0|-0.25|0.29|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||0.29|-0.25|
70936201|NCT00749944|141373001|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.1|||||TWO_SIDED|95.0|-0.37|0.58|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.58|-0.37|
70936202|NCT00749944|141373001|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.08|||||TWO_SIDED|95.0|-0.17|0.34|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.34|-0.17|
71028130|NCT00810368|141563183|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||t-test, 2 sided|||||||0.40
71028131|NCT00810368|141563184|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED|||||Using Fisher's Exact Test, we determined whether there was a significant difference in the number of participants complaining of IBS symptoms.|Fisher Exact|2 by 2 Fisher's Exact Test||||||0.018
71028132|NCT00810368|141563185|SUPERIORITY_OR_OTHER|||||||0.0018|TWO_SIDED||||||t-test, 2 sided|||||||0.0018
71028133|NCT00810368|141563185|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||t-test, 2 sided|||||||0.60
71028134|NCT00810368|141563187|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.5
70936203|NCT00749944|141373001|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.04|||||TWO_SIDED|95.0|-0.4|0.48|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||0.48|-0.40|
70936204|NCT00749944|141373001|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.17|||||TWO_SIDED|95.0|-0.44|0.78|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.78|-0.44|
71028135|NCT00810368|141563188|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.5
71028136|NCT00810368|141563189|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.50
71028137|NCT02428699|141563215|SUPERIORITY||Mean Difference (Net)|5.16|||<|0.0001|TWO_SIDED|95.0|2.79|7.53|||ANCOVA|Subject as random effect,treatment and period as fixed effects,subject and period level baseline values for plasma total and free acids as covariates|Difference is test minus reference such that a positive difference favors the test treatment.|||7.53|2.79|<.0001
71028138|NCT03365375|141563254|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.82|TWO_SIDED||||||t-test, 2 sided|||||||0.82
71028139|NCT02483975|141563266|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non inferiority was demonstrated if the lower limit of the two-sided 95% CI for the geometric mean ratio of each dose of fluticasone furoate 50 µg versus placebo was greater than 0.8.|Least square Geometric Mean ratio|0.92|||||TWO_SIDED|95.0|0.804|1.0505||||||||1.0505|0.8040|
71028140|NCT02483975|141563267|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non inferiority was demonstrated if the lower limit of the two-sided 95% CI for the geometric mean ratio of each dose of fluticasone furoate 50 µg versus placebo was greater than 0.8.|Least square Geometric Mean ratio|0.93|||||TWO_SIDED|95.0|0.8096|1.062||||||||1.0620|0.8096|
71028141|NCT02483975|141563268|SUPERIORITY_OR_OTHER_LEGACY||Least square Geometric Mean ratio|0.93|||||TWO_SIDED|95.0|0.81|1.06||||||||1.06|0.81|
71028142|NCT02483975|141563269|SUPERIORITY_OR_OTHER_LEGACY||Least square Geometric Mean ratio|0.79|||||TWO_SIDED|95.0|0.61|1.03||||||||1.03|0.61|
71028143|NCT02483975|141563270|SUPERIORITY_OR_OTHER_LEGACY||Least square Geometric Mean ratio|0.88|||||TWO_SIDED|95.0|0.72|1.07||||||||1.07|0.72|
71028144|NCT02684578|141563276|SUPERIORITY|||||||0.39||||||The threshold for statistical significance was p = 0.05.|Linear mixed-effects regression|||||||0.39
71028145|NCT02684578|141563277|SUPERIORITY|||||||0.97||||||The threshold for statistical significance was p = 0.05.|Linear mixed-effects|||||||0.97
71028146|NCT02684578|141563278|SUPERIORITY|||||||0.12||||||The threshold for statistical significance was p = 0.05.|Linear mixed-effects|||||||0.12
70936205|NCT00749944|141373001|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.13|||||TWO_SIDED|95.0|-0.14|0.4|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.40|-0.14|
71028147|NCT03879239|141563293|SUPERIORITY|||||||0.0011||||||Responder Rate on Weekly CSBM1 in the ITT (Intention to Treat) analysis set. (For details, refer to the primary outcome description).|Chi-squared|||||||0.0011
71028148|NCT03879239|141563293|SUPERIORITY|||||||0.0085||||||Responder Rate on Weekly CSBM2 in the ITT (Intention to Treat) analysis set. (For details, refer to the primary outcome description).|Chi-squared|||||||0.0085
71028149|NCT01193608|141563351|SUPERIORITY_OR_OTHER||Mean change|113.53||||0.599|TWO_SIDED|80.0|-170.3|397.35|||t-test, 2 sided||One sample paired t-test|Change from baseline, within group||397.35|-170.30|0.599
71028150|NCT01193608|141563353|SUPERIORITY_OR_OTHER||Mean change|48.85||||0.297|TWO_SIDED|80.0|-11.79|109.48|||t-test, 2 sided||One sample paired t-test|Change from baseline, within group||109.48|-11.79|0.297
71028151|NCT01193608|141563355|SUPERIORITY_OR_OTHER||Mean change|-15.26||||0.6|TWO_SIDED|80.0|-53.54|23.02|||t-test, 2 sided||One sample paired t-test|Change from baseline, within group||23.02|-53.54|0.600
70936206|NCT00749944|141373004|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.41|||||TWO_SIDED|95.0|-1.09|1.9|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.90|-1.09|
71028152|NCT01193608|141563357|SUPERIORITY_OR_OTHER||Mean change|1.23||||0.603|TWO_SIDED|80.0|-1.89|4.35|||t-test, 2 sided||One sample paired t-test|Change from baseline, within group||4.35|-1.89|0.603
71028153|NCT00266409|141563365|SUPERIORITY_OR_OTHER|||||||0.1143||95.0|||||Generalized Wilcoxon|||This analysis refers to the test of the null hypothesis that there is no difference in the survival distribution function between the treatment groups.||||0.1143
71028154|NCT00266409|141563365|SUPERIORITY_OR_OTHER|||||||0.4544||95.0|||||Generalized Wilcoxon|||This analysis refers to the test of the null hypothesis that there is no difference in the survival distribution function between the treatment groups.||||0.4544
71028155|NCT00266409|141563366|SUPERIORITY_OR_OTHER|||||||0.0173||95.0|||||ANCOVA|||ANCOVA with treatment as a fixed effect and baseline total HAM-A score as a covariate||||0.0173
71028156|NCT00266409|141563366|SUPERIORITY_OR_OTHER|||||||0.0516||95.0|||||ANCOVA|||ANCOVA with treatment as a fixed effect and baseline total HAM-A score as a covariate||||0.0516
71028157|NCT00266409|141563367|SUPERIORITY_OR_OTHER|||||||0.0361||95.0||||P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.0361
71028158|NCT00266409|141563367|SUPERIORITY_OR_OTHER|||||||0.0366||95.0||||P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.0366
71028159|NCT00266409|141563368|SUPERIORITY_OR_OTHER|||||||0.739||95.0||||P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.7390
71028160|NCT00266409|141563368|SUPERIORITY_OR_OTHER|||||||0.6735||95.0||||P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.6735
71028161|NCT00266409|141563369|SUPERIORITY_OR_OTHER|||||||0.4261||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.4261
71028162|NCT00266409|141563369|SUPERIORITY_OR_OTHER|||||||0.0231||95.0||||P-value based on ANCOVA with treatment as a fixed effect and baseline HAM-A score as a covariate|ANCOVA|||||||0.0231
71028163|NCT00266409|141563370|SUPERIORITY_OR_OTHER|||||||0.182||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and total HAM-A score as a covariate|ANCOVA|||||||0.1820
71028164|NCT00266409|141563370|SUPERIORITY_OR_OTHER|||||||0.2187||95.0||||P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as covariate|ANCOVA|||||||0.2187
71028165|NCT00266409|141563371|SUPERIORITY_OR_OTHER|||||||0.1456||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.1456
71028166|NCT00266409|141563371|SUPERIORITY_OR_OTHER|||||||0.3618||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.3618
71028167|NCT00266409|141563372|SUPERIORITY_OR_OTHER|||||||0.3535||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.3535
71028168|NCT00266409|141563372|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.5660
71028169|NCT00266409|141563373|SUPERIORITY_OR_OTHER|||||||0.3414||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.3414
71028170|NCT00266409|141563373|SUPERIORITY_OR_OTHER|||||||0.7344||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.7344
71028171|NCT00266409|141563374|SUPERIORITY_OR_OTHER|||||||0.1197||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.1197
71028172|NCT00266409|141563374|SUPERIORITY_OR_OTHER|||||||0.4416||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.4416
71028173|NCT00266409|141563375|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.0350
71028174|NCT00266409|141563375|SUPERIORITY_OR_OTHER|||||||0.4205||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.4205
71028175|NCT00266409|141563376|SUPERIORITY_OR_OTHER|||||||0.2645||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.2645
71060014|NCT02729909|141627249|SUPERIORITY||Median Value of CI|0.6|||<|0.001|TWO_SIDED|95.0|0.4|0.9||Mean Degree of Stool Consistency was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 2||0.9|0.4|<0.001
71028176|NCT00266409|141563376|SUPERIORITY_OR_OTHER|||||||0.5369||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.5369
71028177|NCT00266409|141563377|SUPERIORITY_OR_OTHER|||||||0.9988||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.9988
71028178|NCT00266409|141563377|SUPERIORITY_OR_OTHER|||||||0.7729||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.7729
71028179|NCT00266409|141563378|SUPERIORITY_OR_OTHER|||||||0.7338||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.7338
71028180|NCT00266409|141563378|SUPERIORITY_OR_OTHER|||||||0.0897||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.0897
71028181|NCT00266409|141563379|SUPERIORITY_OR_OTHER|||||||0.6501||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.6501
71028182|NCT00266409|141563379|SUPERIORITY_OR_OTHER|||||||0.8196||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.8196
71028183|NCT00266409|141563380|SUPERIORITY_OR_OTHER|||||||0.6404||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.6404
71028184|NCT00266409|141563380|SUPERIORITY_OR_OTHER|||||||0.8263||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.8263
71028185|NCT00266409|141563381|SUPERIORITY_OR_OTHER|||||||0.6946||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.6946
71078022|NCT02081014|141664555|SUPERIORITY_OR_OTHER||Point estimate ratio|0.73|STANDARD_ERROR_OF_MEAN|0.88|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
70936207|NCT00749944|141373004|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.08|||||TWO_SIDED|95.0|-1.54|1.71|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||1.71|-1.54|
70936208|NCT00749944|141373004|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.06|||||TWO_SIDED|95.0|-2.47|2.6|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||2.60|-2.47|
71109603|NCT02722408|141724369|OTHER|||||||0.297||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.2970
71109604|NCT02722408|141724369|OTHER|||||||0.0092||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.0092
71109605|NCT02722408|141724369|OTHER|||||||0.0049||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.0049
71109606|NCT02722408|141724369|OTHER|||||||0.0033||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.0033
70936209|NCT00749944|141373004|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.29|||||TWO_SIDED|95.0|-1.57|2.15|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||2.15|-1.57|
71028186|NCT00266409|141563381|SUPERIORITY_OR_OTHER|||||||0.9629||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.9629
71028187|NCT00266409|141563382|SUPERIORITY_OR_OTHER|||||||0.8617||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.8617
71028188|NCT00266409|141563382|SUPERIORITY_OR_OTHER|||||||0.7555||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.7555
71028189|NCT00266409|141563383|SUPERIORITY_OR_OTHER|||||||0.5836||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.5836
71028190|NCT00266409|141563383|SUPERIORITY_OR_OTHER|||||||0.9096||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.9096
71028191|NCT00266409|141563384|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0002
71028192|NCT00266409|141563384|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0006
71028193|NCT00266409|141563385|SUPERIORITY_OR_OTHER|||||||0.0255||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint, CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0255
71028194|NCT00266409|141563385|SUPERIORITY_OR_OTHER|||||||0.0065||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0065
71028195|NCT00266409|141563386|SUPERIORITY_OR_OTHER|||||||0.037||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0370
71028196|NCT00266409|141563386|SUPERIORITY_OR_OTHER|||||||0.9569||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.9569
71028197|NCT00266409|141563387|SUPERIORITY_OR_OTHER|||||||0.0978||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0978
71028198|NCT00266409|141563387|SUPERIORITY_OR_OTHER|||||||0.7096||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.7096
71028199|NCT00266409|141563388|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0001
70852300|NCT03060551|141193179|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.019||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.019
71028200|NCT00266409|141563388|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0003
70852301|NCT03060551|141193180|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.05||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.050
71028201|NCT00266409|141563389|SUPERIORITY_OR_OTHER|||||||0.0025||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0025
71028202|NCT00266409|141563389|SUPERIORITY_OR_OTHER|||||||0.0101||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0101
71028203|NCT00266409|141563390|SUPERIORITY_OR_OTHER|||||||0.0095||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0095
71028204|NCT00266409|141563390|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0390
71028205|NCT00266409|141563391|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0160
71028206|NCT00266409|141563391|SUPERIORITY_OR_OTHER|||||||0.1024||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.1024
71028207|NCT00266409|141563392|SUPERIORITY_OR_OTHER|||||||0.0761||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0761
71028208|NCT00266409|141563392|SUPERIORITY_OR_OTHER|||||||0.0376||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0376
71028209|NCT00266409|141563393|SUPERIORITY_OR_OTHER|||||||0.1196||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.1196
71028210|NCT00266409|141563393|SUPERIORITY_OR_OTHER|||||||0.0029||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint.CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0029
71028211|NCT00266409|141563394|SUPERIORITY_OR_OTHER|||||||0.6323||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.6323
71028212|NCT00266409|141563394|SUPERIORITY_OR_OTHER|||||||0.5533||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.5533
71028213|NCT00266409|141563395|SUPERIORITY_OR_OTHER|||||||0.1705||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.1705
70936210|NCT00749944|141373004|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.94|||||TWO_SIDED|95.0|-2.23|0.36|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||0.36|-2.23|
70936211|NCT00749944|141373004|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.74|||||TWO_SIDED|95.0|-2.81|1.33|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||1.33|-2.81|
70936212|NCT00749944|141373004|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.43|||||TWO_SIDED|95.0|-1.78|0.92|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.92|-1.78|
70936213|NCT00749944|141373005|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.08|||||TWO_SIDED|95.0|-0.04|0.19|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.19|-0.04|
70936214|NCT00749944|141373005|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.01|||||TWO_SIDED|95.0|-0.11|0.08|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||0.08|-0.11|
71028214|NCT00266409|141563395|SUPERIORITY_OR_OTHER|||||||0.3196||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.3196
71028215|NCT00266409|141563396|SUPERIORITY_OR_OTHER|||||||0.0419||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0419
71028216|NCT00266409|141563396|SUPERIORITY_OR_OTHER|||||||0.2541||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.2541
71028217|NCT00266409|141563397|SUPERIORITY_OR_OTHER|||||||0.0677||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.0677
71028218|NCT00266409|141563397|SUPERIORITY_OR_OTHER|||||||0.0273||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.0273
71028219|NCT00266409|141563398|SUPERIORITY_OR_OTHER|||||||0.5153||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.5153
71028220|NCT00266409|141563398|SUPERIORITY_OR_OTHER|||||||0.0122||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.0122
70936215|NCT00749944|141373005|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.02|||||TWO_SIDED|95.0|-0.06|0.09|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.09|-0.06|
71028221|NCT00266409|141563399|SUPERIORITY_OR_OTHER|||||||0.4648||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.4648
70936216|NCT00749944|141373005|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.05|||||TWO_SIDED|95.0|-0.11|0.02|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.02|-0.11|
70936217|NCT00749944|141373005|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.14|||||TWO_SIDED|95.0|-0.27|-0.01|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||-0.01|-0.27|
70936218|NCT00749944|141373005|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.1|||||TWO_SIDED|95.0|-0.21|0.01|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.01|-0.21|
71028222|NCT00266409|141563399|SUPERIORITY_OR_OTHER|||||||0.5502||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.5502
71028223|NCT00266409|141563400|SUPERIORITY_OR_OTHER|||||||0.9093||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.9093
71028224|NCT00266409|141563400|SUPERIORITY_OR_OTHER|||||||0.1354||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.1354
71028225|NCT00266409|141563401|SUPERIORITY_OR_OTHER|||||||0.7434||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.7434
70936219|NCT00749944|141373005|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.1|||||TWO_SIDED|95.0|-0.17|-0.03|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||-0.03|-0.17|
70936220|NCT00749944|141373006|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.05|||||TWO_SIDED|95.0|-0.03|0.12|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.12|-0.03|
70936221|NCT00749944|141373006|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.0|||||TWO_SIDED|95.0|-0.08|0.09|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||0.09|-0.08|
71028226|NCT00266409|141563401|SUPERIORITY_OR_OTHER|||||||0.1148||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.1148
71028227|NCT00266409|141563402|SUPERIORITY_OR_OTHER|||||||0.9346||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A insomnia subscore as a covariate|ANCOVA|||||||0.9346
71028228|NCT00266409|141563402|SUPERIORITY_OR_OTHER|||||||0.2709||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.2709
71028229|NCT00266409|141563403|SUPERIORITY_OR_OTHER|||||||0.3827||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.3827
71028230|NCT00266409|141563403|SUPERIORITY_OR_OTHER|||||||0.2513||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.2513
71028231|NCT00266409|141563404|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.3930
71028232|NCT00266409|141563404|SUPERIORITY_OR_OTHER|||||||0.5461||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.5461
71028233|NCT00266409|141563405|SUPERIORITY_OR_OTHER|||||||0.0722||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.0722
71028234|NCT00266409|141563405|SUPERIORITY_OR_OTHER|||||||0.4639||95.0||||P-values based on an ANCOVA with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.4639
71028235|NCT00266409|141563406|SUPERIORITY_OR_OTHER|||||||0.0075||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.0075
71028236|NCT00266409|141563406|SUPERIORITY_OR_OTHER|||||||0.1641||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A psychic factors subscore as a covariate|ANCOVA|||||||0.1641
71028237|NCT00266409|141563407|SUPERIORITY_OR_OTHER|||||||0.0932||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.0932
71028238|NCT00266409|141563407|SUPERIORITY_OR_OTHER|||||||0.0852||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.0852
71028239|NCT00266409|141563408|SUPERIORITY_OR_OTHER|||||||0.7896||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.7896
71028240|NCT00266409|141563408|SUPERIORITY_OR_OTHER|||||||0.9651||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.9651
71028241|NCT00266409|141563409|SUPERIORITY_OR_OTHER|||||||0.828||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.8280
71028242|NCT00266409|141563409|SUPERIORITY_OR_OTHER|||||||0.0936||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.0936
71028243|NCT00266409|141563410|SUPERIORITY_OR_OTHER|||||||0.3539||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.3539
71028244|NCT00266409|141563410|SUPERIORITY_OR_OTHER|||||||0.4672||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.4672
71028245|NCT00266409|141563411|SUPERIORITY_OR_OTHER|||||||0.255||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.2550
71028246|NCT00266409|141563411|SUPERIORITY_OR_OTHER|||||||0.3125||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.3125
71028247|NCT00266409|141563412|SUPERIORITY_OR_OTHER|||||||0.3174||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.3174
71028248|NCT00266409|141563412|SUPERIORITY_OR_OTHER|||||||0.9427||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.9427
71028249|NCT00266409|141563413|SUPERIORITY_OR_OTHER|||||||0.3252||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.3252
71028250|NCT00266409|141563413|SUPERIORITY_OR_OTHER|||||||0.609||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.6090
71028251|NCT00266409|141563414|SUPERIORITY_OR_OTHER|||||||0.1247||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.1247
71028252|NCT00266409|141563414|SUPERIORITY_OR_OTHER|||||||0.843||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.8430
71028253|NCT00266409|141563415|SUPERIORITY_OR_OTHER|||||||0.1031||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.1031
71028254|NCT00266409|141563415|SUPERIORITY_OR_OTHER|||||||0.0543||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.0543
71028255|NCT00266409|141563416|SUPERIORITY_OR_OTHER|||||||0.0508||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.0508
71028256|NCT00266409|141563416|SUPERIORITY_OR_OTHER|||||||0.0871||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.0871
71028257|NCT00266409|141563417|SUPERIORITY_OR_OTHER|||||||0.8318||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.8318
71028258|NCT00266409|141563417|SUPERIORITY_OR_OTHER|||||||0.5375||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.5375
71028259|NCT00266409|141563418|SUPERIORITY_OR_OTHER|||||||0.2186||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.2186
70936222|NCT00749944|141373006|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.03|||||TWO_SIDED|95.0|-0.04|0.11|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.11|-0.04|
71028260|NCT00266409|141563418|SUPERIORITY_OR_OTHER|||||||0.0422||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.0422
71028261|NCT00266409|141563419|SUPERIORITY_OR_OTHER|||||||0.1164||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.1164
71028262|NCT00266409|141563419|SUPERIORITY_OR_OTHER|||||||0.1935||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.1935
71028263|NCT00266409|141563420|SUPERIORITY_OR_OTHER|||||||0.1244||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.1244
71028264|NCT00266409|141563420|SUPERIORITY_OR_OTHER|||||||0.6182||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.6182
71028265|NCT00266409|141563421|SUPERIORITY_OR_OTHER|||||||0.4589||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.4589
71028266|NCT00266409|141563421|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.3930
70936223|NCT00749944|141373006|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.01|||||TWO_SIDED|95.0|-0.08|0.05|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.05|-0.08|
70936224|NCT00749944|141373006|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.08|||||TWO_SIDED|95.0|-0.22|0.06|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||0.06|-0.22|
70936225|NCT00749944|141373006|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.03|||||TWO_SIDED|95.0|-0.14|0.09|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.09|-0.14|
71028267|NCT00266409|141563422|SUPERIORITY_OR_OTHER|||||||0.445||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.4450
71028268|NCT00266409|141563422|SUPERIORITY_OR_OTHER|||||||0.2924||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.2924
71028269|NCT00266409|141563423|SUPERIORITY_OR_OTHER|||||||0.2184||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.2184
71028270|NCT00266409|141563423|SUPERIORITY_OR_OTHER|||||||0.1281||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.1281
71109607|NCT02722408|141724369|OTHER|||||||0.0618||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0618
71109608|NCT02722408|141724369|OTHER|||||||0.0298||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.0298
71109609|NCT02722408|141724369|OTHER|||||||0.0352||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0352
71028271|NCT00266409|141563424|SUPERIORITY_OR_OTHER|||||||0.6602||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.6602
71028272|NCT00266409|141563425|SUPERIORITY_OR_OTHER|||||||0.5544||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.5544
71028273|NCT00266409|141563426|SUPERIORITY_OR_OTHER|||||||0.9269||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.9269
71028274|NCT00266409|141563427|SUPERIORITY_OR_OTHER|||||||0.5271||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.5271
71028275|NCT00266409|141563428|SUPERIORITY_OR_OTHER|||||||0.1447||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.1447
71028276|NCT00266409|141563429|SUPERIORITY_OR_OTHER|||||||0.9375||95.0||||P-value from a Chi-squared test|Chi-squared|||||||0.9375
71028277|NCT00266409|141563430|SUPERIORITY_OR_OTHER|||||||0.9883||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.9883
71028278|NCT00266409|141563431|SUPERIORITY_OR_OTHER|||||||0.3093||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.3093
71028279|NCT00266409|141563432|SUPERIORITY_OR_OTHER|||||||0.5824||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.5824
71109610|NCT02722408|141724369|OTHER|||||||0.0001||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0001
71109611|NCT02722408|141724369|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||<0.0001
71109612|NCT02722408|141724369|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||<0.0001
70936226|NCT00749944|141373006|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.05|||||TWO_SIDED|95.0|-0.11|0.02|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.02|-0.11|
70936227|NCT00749944|141373007|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.06|||||TWO_SIDED|95.0|-0.2|0.09|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.09|-0.20|
70936228|NCT00749944|141373007|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.02|||||TWO_SIDED|95.0|-0.15|0.12|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||0.12|-0.15|
70936229|NCT00749944|141373007|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.05|||||TWO_SIDED|95.0|-0.15|0.04|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.04|-0.15|
70936230|NCT00749944|141373007|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.08|||||TWO_SIDED|95.0|-0.2|0.04|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.04|-0.20|
70936231|NCT00749944|141373007|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.05|||||TWO_SIDED|95.0|-0.17|0.27|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||0.27|-0.17|
70936232|NCT00749944|141373007|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.05|||||TWO_SIDED|95.0|-0.21|0.1|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.10|-0.21|
70936233|NCT00749944|141373007|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.05|||||TWO_SIDED|95.0|-0.17|0.07|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.07|-0.17|
71028280|NCT00266409|141563433|SUPERIORITY_OR_OTHER|||||||0.044||95.0|||||Generalized Wilcoxon Test|||This analysis refers to the test of the null hypothesis that there is no difference in the survival distribution function between the treatment groups.||||0.044
71028281|NCT00266409|141563433|SUPERIORITY_OR_OTHER|||||||0.6587||95.0|||||Generalized Wilcoxon Test|||This analysis refers to the test of the null hypothesis that there is no difference in the survival distribution function between the treatment groups.||||0.6587
71028282|NCT00635154|141563437|SUPERIORITY_OR_OTHER||Proportion of confirmed responses (%)|1.8||||||95.0|0.5|10.0|||||95% Confidence intervals were calculated for the true confirmed response rate using properties of the binomial distribution.|Proportion of confirmed responses to Anakinra alone was estimated by the number of patients who achieved a confirmed response divided by the total number of assessable patients.||10|0.5|
70936234|NCT00749944|141373008|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.3|||||TWO_SIDED|95.0|-0.58|-0.02|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||-0.02|-0.58|
70852302|NCT03060551|141193181|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.372||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.372
70936235|NCT00749944|141373008|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.44|||||TWO_SIDED|95.0|-0.69|-0.19|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||-0.19|-0.69|
70936236|NCT00749944|141373008|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.14|||||TWO_SIDED|95.0|-0.47|0.2|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.20|-0.47|
70936237|NCT00749944|141373008|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.35|||||TWO_SIDED|95.0|-0.61|-0.09|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||-0.09|-0.61|
70936238|NCT00749944|141373008|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.45|||||TWO_SIDED|95.0|-0.83|-0.07|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||-0.07|-0.83|
70936239|NCT00749944|141373008|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.08|||||TWO_SIDED|95.0|-0.5|0.34|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.34|-0.50|
70936240|NCT00749944|141373008|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.27|||||TWO_SIDED|95.0|-0.57|0.02|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.02|-0.57|
71028283|NCT01399736|141563444|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.001|TWO_SIDED|95.0|0.22|0.55|||Chi-squared|||||0.55|0.22|<0.001
71028284|NCT01399736|141563445|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.7|TWO_SIDED|95.0|0.25|2.56|||Chi-squared|||||2.56|0.25|0.70
71028285|NCT01399736|141563446|SUPERIORITY||Hazard Ratio (HR)|1.0||||1|TWO_SIDED|95.0|0.25|4.01|||Chi-squared|||||4.01|0.25|1.00
71028286|NCT01399736|141563447|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.1|TWO_SIDED|95.0|0.22|1.13|||Chi-squared|||||1.13|0.22|0.10
71028287|NCT01399736|141563448|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.29|TWO_SIDED|95.0|0.22|1.59|||Chi-squared|||||1.59|0.22|0.29
71028288|NCT01399736|141563449|SUPERIORITY||Hazard Ratio (HR)|0.37|||<|0.001|TWO_SIDED|95.0|0.24|0.57|||Chi-squared|||||0.57|0.24|<0.001
71028289|NCT01399736|141563450|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.8|TWO_SIDED|95.0|0.29|5.02|||Chi-squared|||||5.02|0.29|0.80
71028290|NCT01089647|141563487|OTHER||||||=|0.946|||||||ANOVA|||Between-group comparisons at follow-up were made using a stepwise multivariable logistic model.||||=0.946
71028291|NCT00995553|141563488|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||ANOVA|||MATRICS Working Memory Index||||.06
71028292|NCT00995553|141563488|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||ANOVA|||MATRICS Attention Index||||.09
71028293|NCT00995553|141563489|SUPERIORITY_OR_OTHER|||||||0.73|||||||ANOVA|||||||.73
71028294|NCT01626079|141563505|NON_INFERIORITY|Two thousand (2000) simulations were performed to calculate sample size and power for the primary safety endpoint. Assuming 22% mortality and 7.5% attrition at 12 months, a total of 305 subjects in the Device group will provide \> 95% power to reject the null hypothesis at the one-sided significance level of 5%.|Kaplan Meier|0.966|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|ONE_SIDED|95.0|0.948||||Z test Using Kaplan Meier Survival|P-value calculated from Z test using Kaplan Meier survival estimate together with Greenwood method estimated variance|||||0.948|<0.0001
71028295|NCT01626079|141563538|SUPERIORITY||Hazard Ratio (HR)|0.76|||<|0.02|TWO_SIDED|95.0|0.6|0.96|||Joint Fraility Model|||||0.96|0.60|<0.02
71028296|NCT01626079|141563539|SUPERIORITY||Win Ratio|1.61|||<|0.0001|TWO_SIDED|95.0|1.29|2.04|||Finkelstein-Schoenfeld Analysis|||||2.04|1.29|<0.0001
71028297|NCT04799158|141563886|SUPERIORITY||Percentage difference|28.7|||<|0.0001|TWO_SIDED|95.0|21.84|35.55|||Fisher Exact|||||35.55|21.84|<0.0001
71028298|NCT04799158|141563886|SUPERIORITY||Percentage difference|33.3|||<|0.0001|TWO_SIDED|95.0|26.28|40.23|||Fisher Exact|||||40.23|26.28|<0.0001
71028299|NCT04799158|141563886|SUPERIORITY||Percentage difference|42.7|||<|0.0001|TWO_SIDED|95.0|35.92|49.42|||Fisher Exact|||||49.42|35.92|<0.0001
70852303|NCT03060551|141193182|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.024||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.024
71028300|NCT04799158|141563887|SUPERIORITY||Percentage difference|30.3|||<|0.0001|TWO_SIDED|95.0|23.41|37.09|||Fisher Exact|||||37.09|23.41|<0.0001
71028301|NCT04799158|141563887|SUPERIORITY||Percentage difference|23.9|||<|0.0001|TWO_SIDED|95.0|16.67|31.05|||Fisher Exact|||||31.05|16.67|<0.0001
71028302|NCT04799158|141563887|SUPERIORITY||Percentage difference|37.7|||<|0.0001|TWO_SIDED|95.0|31.0|44.35|||Fisher Exact|||||44.35|31.00|<0.0001
71028303|NCT04799158|141563888|SUPERIORITY|||||||0.1771|||||||Wilcoxon rank-sum test|||||||0.1771
71028304|NCT04799158|141563888|SUPERIORITY|||||||0.1551|||||||Wilcoxon rank-sum test|||||||0.1551
71028305|NCT04799158|141563888|SUPERIORITY|||||||0.0094|||||||Wilcoxon rank-sum test|||||||0.0094
71028306|NCT04799158|141563889|SUPERIORITY|||||||0.3395|||||||Wilcoxon rank-sum test|||||||0.3395
70852304|NCT03060551|141193183|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.188||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.188
71028307|NCT04799158|141563889|SUPERIORITY|||||||0.4882|||||||Wilcoxon rank-sum test|||||||0.4882
71028308|NCT04799158|141563889|SUPERIORITY|||||||0.0722|||||||Wilcoxon rank-sum test|||||||0.0722
71028309|NCT04799158|141563890|SUPERIORITY||Percentage difference|-3.9||||0.83|TWO_SIDED|95.0|-24.41|16.52|||Fisher Exact|||||16.52|-24.41|0.8300
71060015|NCT02729909|141627249|SUPERIORITY||Median Value of CI|0.6|||<|0.001|TWO_SIDED|95.0|0.4|0.8||Mean Degree of Stool Consistency was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 3||0.8|0.4|<0.001
71028310|NCT04799158|141563890|SUPERIORITY||Percentage difference|1.4|||>|0.9999|TWO_SIDED|95.0|-19.28|22.16|||Fisher Exact|||||22.16|-19.28|>0.9999
71028311|NCT04799158|141563890|SUPERIORITY||Percentage difference|2.3|||>|0.9999|TWO_SIDED|95.0|-18.22|22.88|||Fisher Exact|||||22.88|-18.22|>0.9999
71028312|NCT04799158|141563891|SUPERIORITY|||||||0.4684|||||||Wilcoxon rank-sum test|||||||0.4684
71028313|NCT04799158|141563891|SUPERIORITY|||||||0.656|||||||Wilcoxon rank-sum test|||||||0.6560
71028314|NCT04799158|141563891|SUPERIORITY|||||||0.6324|||||||Wilcoxon rank-sum test|||||||0.6324
71028315|NCT04799158|141563892|SUPERIORITY|||||||0.9896|||||||Wilcoxon rank-sum test|||||||0.9896
71028316|NCT04799158|141563892|SUPERIORITY|||||||0.6916|||||||Wilcoxon rank-sum test|||||||0.6916
71028317|NCT04799158|141563892|SUPERIORITY|||||||0.9316|||||||Wilcoxon rank-sum test|||||||0.9316
71028318|NCT03309956|141563918|SUPERIORITY|||||||0.23|||||||McNemar|||||||0.23
71028319|NCT02768298|141563921|SUPERIORITY||Least Squares (LS) Mean|0.32|STANDARD_ERROR_OF_MEAN|0.268||0.2327|TWO_SIDED|95.0|-0.21|0.85|||ANCOVA|||||0.85|-0.21|0.2327
71028320|NCT02768298|141563922|SUPERIORITY||LS Mean|-0.14|STANDARD_ERROR_OF_MEAN|0.277||0.6247|TWO_SIDED|95.0|-0.68|0.41|||ANCOVA|||||0.41|-0.68|0.6247
71028321|NCT02768298|141563923|SUPERIORITY||LS Mean|-1.23|STANDARD_ERROR_OF_MEAN|0.888||0.1678|TWO_SIDED|95.0|-2.98|0.52|||ANCOVA|||6 weeks||0.52|-2.98|0.1678
71028322|NCT02768298|141563923|SUPERIORITY||LS Mean|0.83|STANDARD_ERROR_OF_MEAN|0.809||0.3052|TWO_SIDED|95.0|-0.77|2.43|||ANCOVA|||3 months||2.43|-0.77|0.3052
71028323|NCT02768298|141563924|SUPERIORITY||LS Mean|0.87|STANDARD_ERROR_OF_MEAN|1.744||0.6181|TWO_SIDED|95.0|-2.58|4.32|||ANCOVA|||6 weeks||4.32|-2.58|0.6181
71028324|NCT02768298|141563924|SUPERIORITY||LS Mean|3.28|STANDARD_ERROR_OF_MEAN|2.124||0.1254|TWO_SIDED|95.0|-0.93|7.48|||ANCOVA|||3 months||7.48|-0.93|0.1254
71028325|NCT02768298|141563925|SUPERIORITY||LS Mean|-0.3|STANDARD_ERROR_OF_MEAN|0.317||0.3432|TWO_SIDED|95.0|-0.93|0.33|||ANCOVA|||Borg value dyspnea||0.33|-0.93|0.3432
71028326|NCT02768298|141563925|SUPERIORITY||LS Mean|0.16|STANDARD_ERROR_OF_MEAN|0.251||0.5319|TWO_SIDED|95.0|-0.34|0.65|||ANCOVA|||Borg value fatigue||0.65|-0.34|0.5319
71060016|NCT02729909|141627249|SUPERIORITY||Median Value of CI|0.5|||<|0.001|TWO_SIDED|95.0|0.2|0.7||Mean Degree of Stool Consistency was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 4||0.7|0.2|<0.001
71028327|NCT04603937|141563948|NON_INFERIORITY|The maximum clinically acceptable true difference between KSI-301 and aflibercept participants to be considered non-inferior is 4.5 ETDRS letters, i.e. the non-inferiority margin|Adjusted mean difference|-4.7|STANDARD_ERROR_OF_MEAN|0.97|>|0.9999|TWO_SIDED|95.04|-6.65|-2.81|||Mixed Models Analysis|MMRM model with treatment, visit, treatment by visit interaction, randomization stratification factors, and continuous baseline BCVA and OCT CST.||||-2.81|-6.65|> 0.9999
71028328|NCT04603937|141563949|NON_INFERIORITY|The maximum clinically acceptable non-inferiority margin between KSI-301 and aflibercept subjects is 10% to be considered non-inferior, i.e. the non-inferiority margin is 10%|Difference of weighted percentages|0.6|||<|0.0001|TWO_SIDED|95.04|-0.7|2.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by study identifier and randomization stratification variables.|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||2|-0.7|<0.0001
71028329|NCT04603937|141563950|NON_INFERIORITY|The maximum clinically acceptable non-inferiority margin between KSI-301 and aflibercept subjects is 10% to be considered non-inferior, i.e the non-inferiority margin is 10%|Difference of weighted percentages|1.2|||<|0.0001|TWO_SIDED|95.04|-1.4|3.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by randomization stratification variables.|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||3.9|-1.4|<0.0001
71028330|NCT02518685|141563954|SUPERIORITY||Least-Square Mean Difference|6.7|||<|0.0001|TWO_SIDED|95.0|4.54|8.81|||multiple imputations|||||8.81|4.54|<0.0001
71028331|NCT02518685|141563955|SUPERIORITY|Statistical success criterion for achieving the performance standard of (≥ 50%) of proportion of TPS subjects who have 5% or more TBL at the 12-Month Follow-up|Proportion of Subjects|66.8|||<|0.0001|TWO_SIDED|95.0|59.3|74.3|||Wilson's Midpoint Estimate|||||74.3|59.3|<0.0001
71028332|NCT01611090|141563968|SUPERIORITY||Hazard Ratio (HR)|0.229|||<|0.0001|TWO_SIDED|95.0|0.183|0.286|||Log Rank|||||0.286|0.183|< 0.0001
71028333|NCT01919190|141563982|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.8|TWO_SIDED||||||ANCOVA|||||||>0.8
71028334|NCT01919190|141563983|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0456|TWO_SIDED||||||Mixed Models Analysis|||||||0.0456
71028335|NCT00655642|141563988|NON_INFERIORITY_OR_EQUIVALENCE|Based on the aforementioned values, we calculated a sample size for each treatment arm of 131 patients. We increased this sample estimate to 150 per treatment arm (total of 600 patients) to account for anticipated study attrition. Based on an unplanned interim conditional power futility analysis done at 30% information fraction, the decision was made to end the trial early.The futility analysis found the observed differences were far less than what was deemed clinically important.|Median Difference (Final Values)|12.0|STANDARD_DEVIATION|25.0||0.16||||||Being aware of the multiple comparison issues, we deliberately chose the 0.01 alpha level following a Bonferroni type of correction so that the overall type I error rate is about 0.05.|Kruskal-Wallis|We computed the effect of the 3 treatments relative to ondansetron.|Change in VAS score was calculated as (VAS 30 min - VAS baseline). We calculated the differences in median VAS reductions for each arm relative to ondansetron.|The null hypothesis is that ondanestron is not more effective in reducing nausea than metoclopramide, promethazine or isotonic normal saline. The sample size was chosen to detect a 12-mm difference in VAS improvement between ondanestron and any other treatment arm (assuming a SD of 25mm) at 90% power and 0.01 alpha significance level. We chose the 0.01 alpha level following a Bonferroni type of correction so that the overall type I error rate is about 0.05.||||0.16
71028336|NCT01545076|141563989|SUPERIORITY||Difference in Percent|-24.6|||=|0.007|TWO_SIDED|95.0|-40.7|-6.21|||Fisher Exact|||||-6.21|-40.7|=0.007
71028337|NCT01545076|141563989|SUPERIORITY||Difference in Percent|-30.4|||<|0.001|TWO_SIDED|95.0|-46.0|-12.2|||Fisher Exact|||||-12.2|-46.0|<0.001
71028338|NCT01545076|141563990|OTHER||Median Difference (Net)|0.0|||=|0.005|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank sum|||||0|-1|=0.005
71028339|NCT01545076|141563990|OTHER||Median Difference (Net)|-1.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank sum|||||0|-1|<0.001
71028340|NCT01545076|141563991|OTHER||Median Difference (Net)|7.6|||=|0.004|TWO_SIDED|95.0|2.0|14.0|||Wilcoxon rank sum|||||14|2|=0.004
71028341|NCT01545076|141563991|OTHER||Median Difference (Net)|5.7|||=|0.014|TWO_SIDED|95.0|0.7|11.7|||Wilcoxon rank sum|||||11.7|0.7|=0.014
71028342|NCT01545076|141563992|OTHER||Median Difference (Final Values)|2.0|||=|0.003|TWO_SIDED|95.0|1.0|4.0|||Wilcoxon rank sum|||||4|1|=0.003
71028343|NCT01545076|141563992|OTHER||Median Difference (Final Values)|2.0|||=|0.002|TWO_SIDED|95.0|1.0|4.0|||Wilcoxon rank sum|||||4|1|=0.002
71028344|NCT01545076|141563993|OTHER||Median Difference (Net)|3.0|||=|0.03|TWO_SIDED|95.0|0.0|9.0|||Wilcoxon rank sum|||||9|0|=0.03
71028345|NCT01545076|141563993|OTHER||Median Difference (Net)|5.0|||<|0.001|TWO_SIDED|95.0|2.0|9.0|||Wilcoxon rank sum|||||9|2|<0.001
71078023|NCT02081014|141664555|SUPERIORITY_OR_OTHER||Point estimate ratio|3.23|STANDARD_ERROR_OF_MEAN|3.84|>|0.05|TWO_SIDED||||||Regression, Linear||Geometric means|||||>0.05
71028346|NCT00797108|141564027|SUPERIORITY_OR_OTHER||Clinical Cure Difference|27.5|||||TWO_SIDED|80.0|-4.0|55.3||||||Two-sided 80% confidence interval (CI) for the difference in the clinical cure response rates between treatement group and the comparator was formed using the exact methods.||55.3|-4.0|
71028347|NCT00797108|141564027|SUPERIORITY_OR_OTHER||Clinical Cure Difference|25.0|||||TWO_SIDED|80.0|-13.1|57.9||||||Two-sided 80% CI for the difference in the clinical cure response rates between treatement group and the comparator was formed using the exact methods.||57.9|-13.1|
71028348|NCT02270736|141564037|SUPERIORITY||Least square mean (LS-mean) difference|-0.06|STANDARD_ERROR_OF_MEAN|0.019|=|0.0012|TWO_SIDED|95.0|-0.1|-0.03|||MMRM|||Least square mean (LS-Mean) is from a mixed model repeated measurement (MMRM) analysis with treatment group, pooled investigation sites, and age groups as fixed factors, visit\*treatment as interaction term, visit as repeated factor, and baseline uSFR score as covariate.||-0.03|-0.1|= 0.0012
71028349|NCT02270736|141564038|SUPERIORITY||Least square mean (LS-mean) difference|0.28|STANDARD_ERROR_OF_MEAN|0.127|=|0.032|TWO_SIDED|95.0|0.02|0.53|||MMRM|||LS-Mean is from a MMRM analysis model with treatment group, pooled investigation sites, and age groups as fixed factors, visit\*treatment as interaction term, visit as repeated factor, and baseline Modified Teacher Drooling Scale (mTDS) score as covariate.||0.53|0.02|= 0.032
71028350|NCT02270736|141564040|SUPERIORITY||Least square mean (LS-mean) difference|-0.09|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|-0.12|-0.05|||MMRM|||Statistical analysis at Week 8: LS-Mean is from a MMRM analysis with treatment group, pooled investigation sites, and age groups as fixed factors, visit\*treatment as interaction term, visit as repeated factor, and baseline uSFR score as covariate.||-0.05|-0.12|<0.0001
71028351|NCT02270736|141564040|SUPERIORITY||Least square mean (LS-mean) difference|-0.1|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001|TWO_SIDED|95.0|-0.14|-0.06|||MMRM|||Statistical analysis at Week 12: LS-Mean is from a MMRM analysis with treatment group, pooled investigation sites, and age groups as fixed factors, visit\*treatment as interaction term, visit as repeated factor, and baseline uSFR score as covariate.||-0.06|-0.14|<0.0001
71060017|NCT02729909|141627250|SUPERIORITY||Median Value of CI|-0.5||||0.02|TWO_SIDED|95.0|-0.9|-0.1||Abdominal Bloating was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 1||-0.1|-0.9|0.020
71060018|NCT02729909|141627250|SUPERIORITY|||||||0.072||||||Abdominal Bloating was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 2||||0.072
71060019|NCT02729909|141627250|SUPERIORITY||Median Value of CI|-0.5|||<|0.001|TWO_SIDED|95.0|-0.9|-0.1||Abdominal Bloating was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 3||-0.1|-0.9|<0.001
70936241|NCT00749944|141373009|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.02|||||TWO_SIDED|95.0|-0.12|0.08|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.08|-0.12|
71060020|NCT02729909|141627250|SUPERIORITY||Median Value of CI|-0.5||||0.004|TWO_SIDED|95.0|-0.9|-0.1||Abdominal Bloating was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 4||-0.1|-0.9|0.004
71060021|NCT02085447|141627259|SUPERIORITY|||||||0.012|||||||t-test, 1 sided|||||||.012
71060022|NCT02085447|141627260|SUPERIORITY|||||||0.028|||||||t-test, 1 sided|||||||.028
71060023|NCT02085447|141627261|SUPERIORITY|||||||0.162|||||||t-test, 1 sided|||||||.162
71060024|NCT02085447|141627262|SUPERIORITY|||||||0.021|||||||t-test, 1 sided|||||||.021
71060025|NCT02085447|141627263|SUPERIORITY|||||||0.005|||||||t-test, 1 sided|||||||.005
71060026|NCT02085447|141627264|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<.001
71060027|NCT02085447|141627265|SUPERIORITY|||||||0.197|||||||t-test, 1 sided|||||||.197
71060028|NCT02085447|141627266|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<.001
71060029|NCT02085447|141627267|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<.001
71060030|NCT02085447|141627268|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<.001
71060031|NCT02085447|141627269|SUPERIORITY|||||||0.053|||||||t-test, 1 sided|||||||.053
71060032|NCT02085447|141627270|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<.001
71060033|NCT02085447|141627271|SUPERIORITY|||||||0.821|||||||t-test, 1 sided|||||||.821
71060034|NCT02085447|141627272|SUPERIORITY|||||||0.33|||||||t-test, 1 sided|||||||.330
71060035|NCT02085447|141627273|SUPERIORITY|||||||0.425|||||||t-test, 1 sided|||||||.425
71060036|NCT02085447|141627274|SUPERIORITY|||||||0.577|||||||t-test, 1 sided|||||||.577
71060037|NCT02085447|141627275|SUPERIORITY|||||||0.33|||||||t-test, 1 sided|||||||.330
71060038|NCT02085447|141627276|SUPERIORITY|||||||0.706|||||||t-test, 1 sided|||||||.706
71060039|NCT02085447|141627277|SUPERIORITY|||||||0.481|||||||t-test, 1 sided|||||||.481
71060040|NCT02085447|141627278|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||||||.020
71060041|NCT02085447|141627279|SUPERIORITY|||||||0.103|||||||t-test, 1 sided|||||||.103
71060042|NCT02085447|141627280|SUPERIORITY|||||||0.063|||||||t-test, 1 sided|||||||.063
70852305|NCT03060551|141193184|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.372||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.372
70936242|NCT00749944|141373009|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.02|||||TWO_SIDED|95.0|-0.12|0.08|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||0.08|-0.12|
70936243|NCT00749944|141373009|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.05|||||TWO_SIDED|95.0|-0.04|0.14|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.14|-0.04|
70936244|NCT00749944|141373009|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.01|||||TWO_SIDED|95.0|-0.07|0.04|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.04|-0.07|
70936245|NCT00749944|141373009|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.01|||||TWO_SIDED|95.0|-0.15|0.13|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||0.13|-0.15|
70936246|NCT00749944|141373009|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.06|||||TWO_SIDED|95.0|0.01|0.1|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.10|0.01|
70936247|NCT00749944|141373009|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.02|||||TWO_SIDED|95.0|-0.08|0.04|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.04|-0.08|
70936248|NCT00749944|141373010|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.12|||||TWO_SIDED|95.0|-0.05|0.28|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.28|-0.05|
70936249|NCT00749944|141373010|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.02|||||TWO_SIDED|95.0|-0.19|0.14|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||0.14|-0.19|
70936250|NCT00749944|141373010|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.04|||||TWO_SIDED|95.0|-0.29|0.22|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.22|-0.29|
70936251|NCT00749944|141373010|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.04|||||TWO_SIDED|95.0|-0.2|0.13|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.13|-0.20|
70936252|NCT00749944|141373010|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.19|||||TWO_SIDED|95.0|-0.4|0.01|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||0.01|-0.40|
70936253|NCT00749944|141373010|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.16|||||TWO_SIDED|95.0|-0.42|0.1|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.10|-0.42|
70936254|NCT00749944|141373010|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.07|||||TWO_SIDED|95.0|-0.22|8.0|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||008|-0.22|
70936255|NCT00749944|141373011|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.6|3.3|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||3.3|0.6|
70936256|NCT00749944|141373011|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.4|1.7|||||Cochran-Mantel-Haenszel|Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.7|0.4|
71109613|NCT02722408|141724370|OTHER|||||||0.3672||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr||||0.3672
70852306|NCT03060551|141193185|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.633||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.633
71109614|NCT02722408|141724370|OTHER|||||||0.2101||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.2101
71109615|NCT02722408|141724370|OTHER|||||||0.3009||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.3009
71109616|NCT02722408|141724370|OTHER|||||||0.1567||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.1567
70936257|NCT00749944|141373011|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.4|2.1|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.1|0.4|
70936258|NCT00749944|141373011|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.4|2.2|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.2|0.4|
70936259|NCT00749944|141373011|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.3|1.4|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.4|0.3|
70936260|NCT00749944|141373011|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.3|1.4|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.4|0.3|
70936261|NCT00749944|141373011|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6|||||TWO_SIDED|95.0|0.3|1.4|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.4|0.3|
70936262|NCT00749944|141373012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5|||||TWO_SIDED|95.0|0.6|10.4|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||10.4|0.6|
70936263|NCT00749944|141373012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.0|||||TWO_SIDED|95.0|0.7|11.8|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||11.8|0.7|
70936264|NCT00749944|141373012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.5|3.9|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||3.9|0.5|
71060043|NCT02730663|141627284|NON_INFERIORITY|The number and percentage of patients who achieved clinical success at the time of stent removal are presented. A one-sided 97.5% confidence interval is to be calculated to confirm the degree of non-inferiority for the reference value (96%) and the difference (Investigational device - reference value) and if the lower limit of the confidence interval is -10% or higher, the noninferiority will be considered to be confirmed.|Reference value|-0.07||||0.05|ONE_SIDED|97.5||||A two-tail test was performed for statistics at a significance level of 0.05 unless otherwise specified.|t-test, 2 sided|||The clinical success rate at the time point of stent removal is reported 86.2% according to the approval data of the commercially available AXIOS stent submitted to the US FDA. The clinical success rates of EUS-guided transluminal drainage using a lumen-appending stent were 93.3% (29 cases), 100% (8 cases) and 100% (7 cases) respectively in the studies performed afterwards by Shah RJ (2015), Gornals JB (2012) and Moon JH (2014). The weighted average calculated for each study was about 96%.||||0.05
71060044|NCT02899962|141627375|SUPERIORITY|The primary endpoint was time to first relapse during the maintenance phase. This was calculated as the number of days from randomisation to the day where the subject had the first relapse confirmed. For subjects who either did not encounter a relapse or were withdrawn from the trial, the number of days was treated as a censored observation at the day of end of trial visit.|Hazard Ratio (HR)|0.57|||<|0.001|TWO_SIDED|95.0|0.47|0.69|||Regression, Cox||Estimates are obtained from a proportional hazards model with treatment group,pooled trial site,disease severity at maintenance baseline (Week 4; determined by PGA) as factors.|All randomized subjects were considered for statistical analysis.||0.69|0.47|<0.001
70936265|NCT00749944|141373012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|0.4|7.8|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||7.8|0.4|
71060045|NCT02899962|141627376|SUPERIORITY||Mean Difference (Net)|0.11|||<|0.001|TWO_SIDED|95.0|0.08|0.14|||ANOVA|Factors adjusted for in the ANOVA model were treatment group, pooled trial site, and disease severity at maintenance baseline (PGA).|Multiple imputation of data for withdrawn subjects was done using 100 imputations and depended on whether the subject's reason for withdrawal potentially was related to treatment. Length of the maintenance phase was assumed to be 52 weeks (364 days)|The number of days in remission was calculated as the sum of days where the subject was in remission periods. The proportion of days in remission was calculated as the number of days in remission divided by the length of the maintenance phase in days.||0.14|0.08|<0.001
70936266|NCT00749944|141373012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2|||||TWO_SIDED|95.0|0.5|9.2|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||9.2|0.5|
70936267|NCT00749944|141373012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.4|3.2|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||3.2|0.4|
71060046|NCT02899962|141627377|SUPERIORITY||Rate ratio|0.54|||<|0.001|TWO_SIDED|95.0|0.46|0.63|||Poisson regression||The number of relapses was analysed using a Poisson regression model with treatment group,pooled sites,disease severity at maintenance baseline as factors, subject as random effect, and time at risk as an offset.|||0.63|0.46|<0.001
70936268|NCT00749944|141373013|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|0.5|3.9|||||Cochran-Mantel-Haenszel|Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||3.9|0.5|
70936269|NCT00749944|141373013|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9|||||TWO_SIDED|95.0|0.7|5.3|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.3|0.7|
70936270|NCT00749944|141373013|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|0.7|4.4|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||4.4|0.7|
70936271|NCT00749944|141373013|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||||TWO_SIDED|95.0|0.5|5.0|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.0|0.5|
70936272|NCT00749944|141373013|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||||TWO_SIDED|95.0|0.8|6.8|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||6.8|0.8|
71060047|NCT01610492|141627394|OTHER||Geometric Mean|0.76|||||TWO_SIDED|95.0|0.57|1.01||||||||1.01|0.57|
71060048|NCT01610492|141627395|OTHER||Geometric Mean|0.27|||||TWO_SIDED|95.0|0.12|0.58||||||||0.58|0.12|
71060049|NCT00866359|141627492|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.4|-0.9|||ANCOVA||Based on an analysis of covariance model for the number of ulcers at Day 85, with treatment group and gender as factors and the baseline ulcer number as a covariate.|||-0.9|-2.4|<0.0001
71060050|NCT00866359|141627493|SUPERIORITY_OR_OTHER_LEGACY||Least Squares mean difference|-26.8|||<|0.0001|TWO_SIDED|95.0|-35.5|-18.0|||ANCOVA||Based on an analysis of covariance model for the oral ulcer pain VAS at Day 85, with treatment group and gender as factors and the baseline oral ulcer pain VAS as a covariate.|||-18.0|-35.5|<0.0001
71060051|NCT00866359|141627496|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-90.07|||<|0.0001|TWO_SIDED|95.0|-125.32|-54.82||The last post-baseline observation was carried forward to Day 85 for participants who discontinued the study before Day 85. For participants who did not have Day 85 visit on the targeted date, the total AUC was adjusted by the actual study days.|ANCOVA||Based on an analysis of covariance model for the number of ulcers at Day 85, with treatment group, gender, and interaction of treatment group and gender as factors and the baseline ulcer number as a covariate.|||-54.82|-125.32|<0.0001
71060052|NCT00866359|141627499|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.7||||0.0007|TWO_SIDED|95.0|-2.7|-0.8|||ANCOVA||Based on an analysis of covariance model for the number of ulcers at Day 85, with treatment group, gender, and interaction of treatment group and gender as factors and the baseline ulcer number as a covariate.|||-0.8|-2.7|0.0007
71060053|NCT00866359|141627500|SUPERIORITY_OR_OTHER_LEGACY||adjusted difference (percentage)|39.1|||<|0.0001|TWO_SIDED|95.0|23.6|54.5|||Cochran-Mantel-Haenszel|Two-sided p-value was based on the CMH test adjusting for gender.|Adjusted difference in proportions = weighted average of treatment differences across gender with the CMH weights.|||54.5|23.6|<0.0001
71060054|NCT00866359|141627501|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.0007|TWO_SIDED|95.0|-1.7|-0.5|||ANCOVA||Based on an Ancova model for change from baseline with treatment group, gender and interaction of treatment group and gender as factors and the baseline value as a covariate.|||-0.5|-1.7|0.0007
70936273|NCT00749944|141373013|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||||TWO_SIDED|95.0|0.8|5.3|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.3|0.8|
71060055|NCT01625091|141627516|SUPERIORITY|||||||0.36|||||||Chi-squared|||||||0.36
71060056|NCT01625091|141627517|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
71060057|NCT01625091|141627518|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.70
71109617|NCT02722408|141724370|OTHER|||||||0.1207||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.1207
71109618|NCT02722408|141724370|OTHER|||||||0.1045||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.1045
70936274|NCT00749944|141373014|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||||TWO_SIDED|95.0|0.5|4.9|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||4.9|0.5|
71060058|NCT01625091|141627519|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|||||||0.98
71060059|NCT01459783|141627536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91||||0.76|TWO_SIDED|95.0|-5.13|6.95||We adopted Bonferroni adjustment for multiple testing and used a significance level of .05/3 = 0.017 to interpret the results for our primary outcomes.|Regression, Linear|Multivariate analyses included non-response weights and controlled for study arm, stratification variables, baseline values, \& intervention duration.|The difference in differences at 12 months is reported as in-person arm minus phone arm values from a multivariable analysis. A positive adjusted difference means worse burden for the in-person arm compared to the phone arm.|Analyses were intention-to-treat. Due to attrition and those ineligible for 12-month follow-up due to study ending before that time, we created survey non-response weights for each wave. Prior to the study, a sample size of 125 participants per group was based on the two primary outcomes, with a Type I Error of 0.025 (Bonferroni adjustment), setting a 0.5-SD difference in outcomes as clinically important, 80% power, 0.45 SD difference in difference in outcomes between groups, and 25% attrition.||6.95|-5.13|0.76
71109619|NCT02722408|141724370|OTHER|||||||0.0631||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0631
71109620|NCT02722408|141724370|OTHER|||||||0.0217||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.0217
71109621|NCT02722408|141724370|OTHER|||||||0.0359||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0359
71060060|NCT01459783|141627537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.49|TWO_SIDED|95.0|-1.74|3.55||We used Bonferroni adjustment for multiple testing and a significance level of .05/3 = 0.017 to interpret the results for our primary outcomes. The behavior measure is analyzed two ways: total number of problems (reported here), and reaction score.|Regression, Linear|Multivariate analyses included non-response weights and controlled for study arm, stratification variables, baseline values, \& intervention duration.|The difference in differences at 12 months is reported as in-person arm minus phone arm values from a multivariable analysis. A positive adjusted difference means worse problems for the in-person arm compared to the phone arm.|Analyses were intention-to-treat. Due to attrition and those ineligible for 12-month follow-up due to study ending before that time, we created survey non-response weights for each wave. Prior to the study, a sample size of 125 participants per group was based on the two primary outcomes, with a Type I Error of 0.025 (Bonferroni adjustment), setting a 0.5-SD difference in outcomes as clinically important, 80% power, 0.45 SD difference in difference in outcomes between groups, and 25% attrition.||3.55|-1.74|0.49
71060061|NCT04927845|141627603|SUPERIORITY||between-group effect size Cohen's d|0.24||||0.008|TWO_SIDED|95.0|0.06|0.41|||linear mixed effects, groupXtime term|||||0.41|0.06|.008
71060062|NCT04927845|141627603|SUPERIORITY||Slope|1.75||||0.03|TWO_SIDED||||||linear mixed effects, groupXtime term|||Per Protocol Analyses of Intervention Effects: comparing the waitlist condition versus only intervention group participants who were program initiators||||.03
71060063|NCT04927845|141627603|SUPERIORITY|||||||0.009|||||||linear mixed effects, groupXtime term|||Per Protocol Analyses of Intervention Effects: concurrent service use was added as a covariate to models.||||.009
71060064|NCT04927845|141627604|SUPERIORITY||between-group effect size Cohen's d|0.11||||0.21|TWO_SIDED||||||linear mixed effects, groupXtime term|||||||.21
71060065|NCT04927845|141627605|SUPERIORITY||between-group effect size Cohen's d|0.19||||0.046|TWO_SIDED|95.0|0.02|0.36|||linear mixed effects, groupXtime term|||||0.36|0.02|.046
71060066|NCT05351164|141627607|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
71060067|NCT05351164|141627608|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71060068|NCT05201794|141627611|SUPERIORITY||Odds Ratio (OR)|67.3|||=|0.1409|ONE_SIDED|80.0|15.2|||One-sided p-value|Exact logistic regression model|P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).|1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).|The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for proof-of-concept (PoC) when the planned interim analysis would have been performed.|||15.2|=0.1409
71060069|NCT05201794|141627611|SUPERIORITY||Odds Ratio (OR)|67.2|||=|0.1418|ONE_SIDED|80.0|14.9|||One-sided p-value|Exact logistic regression model|P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).|1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).|The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for PoC when the planned interim analysis would have been performed.|||14.9|=0.1418
71109622|NCT02722408|141724370|OTHER|||||||0.0001||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0001
71109623|NCT02722408|141724370|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||<0.0001
71109624|NCT02722408|141724370|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||<0.0001
71109625|NCT02722408|141724371|OTHER|||||||0.9417||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.9417
71109626|NCT02722408|141724371|OTHER|||||||0.7722||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.7722
71109627|NCT02722408|141724371|OTHER|||||||0.5283||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.5283
71109628|NCT02722408|141724371|OTHER|||||||0.5905||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.5905
71109629|NCT02722408|141724371|OTHER|||||||0.7682||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.7682
71109630|NCT02722408|141724371|OTHER|||||||0.9245||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.9245
71109631|NCT02722408|141724371|OTHER|||||||0.6325||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.6325
70936275|NCT00749944|141373014|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.4|2.0|||||Cochran-Mantel-Haenszel|Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.0|0.4|
71060070|NCT05201794|141627612|SUPERIORITY||Odds Ratio (OR)|87.8|||=|0.0192|ONE_SIDED|80.0|58.1|||One-sided p-value|Exact logistic regression model|P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).|1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).|The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for PoC when the planned interim analysis would have been performed.|||58.1|=0.0192
71060071|NCT05201794|141627612|SUPERIORITY||Odds Ratio (OR)|62.9|||=|0.1131|ONE_SIDED|80.0|20.0|||One-sided p-value|Exact logistic regression model|P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).|1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).|The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for PoC when the planned interim analysis would have been performed.|||20|=0.1131
71060072|NCT05201794|141627613|SUPERIORITY||Odds Ratio (OR)|85.4|||=|0.0302|ONE_SIDED|80.0|62.6|||One-sided p-value|Exact logistic regression model|P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).|1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).|The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for PoC when the planned interim analysis would have been performed.|||62.6|=0.0302
71060073|NCT05201794|141627613|SUPERIORITY||Odds Ratio (OR)|60.5|||=|0.2239|ONE_SIDED|80.0|-6.3|||One-sided p-value|Exact logistic regression model|P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).|1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).|The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for PoC when the planned interim analysis would have been performed.|||-6.3|=0.2239
71060074|NCT06418529|141627620|OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.85|1.05||||||||1.05|0.85|
71060075|NCT06418529|141627621|OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.83|1.07||||||||1.07|0.83|
71060076|NCT06418529|141627622|OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.79|0.99||||||||0.99|0.79|
71060077|NCT06418529|141627623|OTHER||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.79|1.04||||||||1.04|0.79|
71060078|NCT06418529|141627624|OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.81|1.05||||||||1.05|0.81|
71060079|NCT06418529|141627625|OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.79|1.09||||||||1.09|0.79|
71060080|NCT04653454|141627627|SUPERIORITY|||||||0.129||||||Hypoglycemic Episodes \<54 mg/dL|Wilcoxon (Mann-Whitney)|||||||0.129
71060081|NCT04653454|141627627|SUPERIORITY|||||||0.008||||||Hypoglycemic Episodes \<70 mg/dL|Wilcoxon (Mann-Whitney)|||||||0.008
71060082|NCT04653454|141627628|SUPERIORITY|||||||0.203||||||Hypoglycemic Episodes \<54 mg/dL|Wilcoxon (Mann-Whitney)|||||||0.203
71060083|NCT04653454|141627628|SUPERIORITY||||||<|0.001||||||Hypoglycemic Episodes \<70 mg/dL|Wilcoxon (Mann-Whitney)|||||||<0.001
71060084|NCT04653454|141627630|SUPERIORITY|||||||0.076||||||Hyperglycemic Episodes \>180 mg/dL|Wilcoxon (Mann-Whitney)|||||||0.076
71060085|NCT04653454|141627630|SUPERIORITY|||||||0.038||||||Hyperglycemic Episodes \>250 mg/dL|Wilcoxon (Mann-Whitney)|||||||0.038
71060086|NCT04653454|141627631|SUPERIORITY||||||<|0.0001||||||Creatinine|Spearman Correlation coefficients|||||||<0.0001
71060087|NCT04653454|141627631|SUPERIORITY|||||||0.0002||||||139GFR|Spearman Correlation coefficients|||||||0.0002
71060088|NCT04653454|141627631|SUPERIORITY|||||||0.22||||||Bicarbonate|Spearman Correlation coefficients|||||||0.22
71060089|NCT04653454|141627631|SUPERIORITY|||||||0.48||||||Hemoglobin|Spearman Correlation coefficients|||||||0.48
71060090|NCT04653454|141627631|SUPERIORITY|||||||0.77||||||MAP|Spearman Correlation coefficients|||||||0.77
71060091|NCT04653454|141627631|SUPERIORITY|||||||0.0516||||||SpO2|Spearman Correlation coefficients|||||||0.0516
71060092|NCT03620708|141627636|SUPERIORITY||chi-square|3.492|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
71060093|NCT03620708|141627637|SUPERIORITY||chi-square|4.36||||0.113|TWO_SIDED||||||Chi-squared|||||||.113
71060094|NCT03620708|141627638|SUPERIORITY||Mean Difference (Final Values)|3.661||||0.032|TWO_SIDED||||||ANOVA|||||||.032
71060095|NCT03620708|141627639|SUPERIORITY||Mean Difference (Final Values)|1.543||||0.227|TWO_SIDED||||||ANOVA|||Examination of differences between groups at follow-up on a measure of confidence in ability to quit.||||.227
71060096|NCT03620708|141627639|SUPERIORITY||Mean Difference (Final Values)|0.338||||0.715|TWO_SIDED||||||ANOVA|||Examination of differences between groups at follow-up on a measure of self-reported importance of quitting smoking.||||.715
71060097|NCT03620708|141627639|SUPERIORITY||Mean Difference (Final Values)|1.712||||0.19|TWO_SIDED||||||ANOVA|||Examination of differences between groups at follow-up on a measure of self-reported readiness to quit smoking.||||.190
71060098|NCT03620708|141627640|SUPERIORITY||Mean Difference (Final Values)|1.728||||0.188|TWO_SIDED||||||ANOVA|||||||.188
71060099|NCT05525520|141627652|EQUIVALENCE|two-sided equivalence test|Least square mean difference (LSMD)|0.46|STANDARD_ERROR_OF_MEAN|0.609||0.4577|TWO_SIDED|95.0|-0.77|1.68|||MMRM|Treatment, type of cholestatic disease, week, and treatment-by-week interaction were fixed effects, and Baseline WI-NRS score was a covariate.|LSMD=EP547 minus placebo|||1.68|-0.77|0.4577
71060100|NCT03176134|141627673|OTHER||Estimated Difference|6.5|||||TWO_SIDED|95.0|-12.2|25.3|||||The estimated difference in the clinical success rate and 2-sided 95% confidence interval (CI) were calculated using the unstratified method of Miettinen and Nurminen.|||25.3|-12.2|
71060101|NCT03176134|141627673|OTHER||Estimated Difference|-12.5|||||TWO_SIDED|95.0|-28.7|3.7|||||The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.|||3.7|-28.7|
71060102|NCT03176134|141627673|OTHER||Estimated Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.|||0.0|0.0|
71060103|NCT03176134|141627673|OTHER||Estimated Difference|1.3|||||TWO_SIDED|95.0|-10.7|13.4|||||The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.|||13.4|-10.7|
71060104|NCT03176134|141627674|OTHER||Estimated Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated difference in the clinical success rate and 2-sided 95% confidence interval (CI) were calculated using the unstratified method of Miettinen and Nurminen.|||0.0|0.0|
71060105|NCT03176134|141627674|OTHER||Estimated Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.|||0.0|0.0|
71060106|NCT03176134|141627674|OTHER||Estimated Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.|||0.0|0.0|
71060107|NCT03176134|141627674|OTHER||Estimated Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.|||0.0|0.0|
71060108|NCT03657797|141627675|NON_INFERIORITY|LS mean, the difference in LS mean (NCX 470 minus latanoprost), and the 2-sided 95% CI for the difference was obtained. Non-inferiority could be claimed if the upper limit of the 2-sided 95% CI around the difference between the LS mean for NCX 470 and the LS mean for latanoprost was \< 1.5 mmHg. If non-inferiority was met, superiority was tested which could be claimed if the p-value for treatment difference was \<= 0.05 and the LS mean difference in change from baseline was \< 0.|Mean Difference (Final Values)|-0.4||||0.2666|TWO_SIDED|95.0|-1.11|0.31||p-value was not adjusted for multiple comparisons|ANCOVA|||NCX 470 0.21% was compared to latanoprost.||0.31|-1.11|0.2666
71060109|NCT03657797|141627675|NON_INFERIORITY|LS mean, the difference in LS mean (NCX 470 minus latanoprost), and the 2-sided 95% CI for the difference was obtained. Non-inferiority could be claimed if the upper limit of the 2-sided 95% CI around the difference between the LS mean for NCX 470 and the LS mean for latanoprost was \< 1.5 mmHg. If non-inferiority was met, superiority was tested which could be claimed if the p-value for treatment difference was \<= 0.05 and the LS mean difference in change from baseline was \< 0.|Mean Difference (Final Values)|-0.81||||0.0281|TWO_SIDED|95.0|-1.52|-0.09||p-value was not adjusted for multiple comparisons|ANCOVA|||NCX 0.042% was compared to latanoprost.||-0.09|-1.52|0.0281
71060110|NCT03657797|141627675|NON_INFERIORITY|LS mean, the difference in LS mean (NCX 470 minus latanoprost), and the 2-sided 95% CI for the difference was obtained. Non-inferiority could be claimed if the upper limit of the 2-sided 95% CI around the difference between the LS mean for NCX 470 and the LS mean for latanoprost was \< 1.5 mmHg. If non-inferiority was met, superiority was tested which could be claimed if the p-value for treatment difference was \<= 0.05 and the LS mean difference in change from baseline was \< 0.|Mean Difference (Final Values)|-1.23||||0.0009|TWO_SIDED|95.0|-1.96|-0.51||p-value was not adjusted for multiple comparisons|ANCOVA|||NCX 0.065% was compared to latanoprost.||-0.51|-1.96|0.0009
71060111|NCT03657797|141627676|NON_INFERIORITY|NCX 470 0.021% was compared to latanoprost 0.005% at each visit. The LS mean, LS mean difference and the 95% CIs for the difference was calculated. Non-inferiority at each visit could be claimed if the upper limit of the 95% CI was \<1.5 mmHg. If non-inferiority was established, superiority could be claimed if the upper limit of the 95% CI was \<0 and p\<0.05.|||||<|0.9788||||||p-value was not adjusted for multiple comparisons|ANCOVA|Upper 95% CIs were 0.51 (week 1), 0.68 (week 2), 0.75 (exit visit); p-values were 0.5560 (week 1), 0.9788 (week 2), 0.8796 (exit visit)||NCX 470 0.021% was compared to latanoprost.||||<0.9788
71060112|NCT03657797|141627676|NON_INFERIORITY|NCX 470 0.042% was compared to latanoprost 0.005% at each visit. The LS mean, LS mean difference and the 95% CIs for the difference was calculated. Non-inferiority at each visit could be claimed if the upper limit of the 95% CI was \<1.5 mmHg. If non-inferiority was established, superiority could be claimed if the upper limit of the 95% CI was \<0 and p\<0.05.|||||<|0.3863||||||p-value was not adjusted for multiple comparisons|ANCOVA|Upper 95% CIs were 0.20 (week 1), 0.38 (week 2), 0.11 (exit visit); p-values were 0.1556 (week 1), 0.3863 (week 2), 0.0912 (exit visit)||NCX 470 0.042% was compared to latanoprost.||||<0.3863
71060113|NCT03657797|141627676|NON_INFERIORITY|NCX 470 0.065% was compared to latanoprost 0.005% at each visit. The LS mean, LS mean difference and the 95% CIs for the difference was calculated. Non-inferiority at each visit could be claimed if the upper limit of the 95% CI was \<1.5 mmHg. If non-inferiority was established, superiority could be claimed if the upper limit of the 95% CI was \<0 and p\<0.05.|||||<|0.0174||||||p-value was not adjusted for multiple comparisons|ANCOVA|Upper 95% CIs were -0.35 (week 1), -0.15 (week 2), -0.27 (exit visit); p-values were 0.0040 (week 1), 0.0174 (week 2), 0.0093 (exit visit)||NCX 470 0.065% was compared to latanoprost.||||<0.0174
71060114|NCT01783990|141627733|SUPERIORITY|||||||0.33|||||||Fisher Exact|||The primary analysis compared the frequency of worsening spleen function (from normal to decreased or absent, or from decreased to absent).||||0.33
71109632|NCT02722408|141724371|OTHER|||||||0.9221||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.9221
71109633|NCT02722408|141724371|OTHER|||||||0.8387||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.8387
71060115|NCT01783990|141627734|SUPERIORITY|||||||0.8|||||||Fisher Exact|||The primary analysis compared the frequency of worsening spleen function (from normal to decreased or absent, or from decreased to absent).||||0.80
71060116|NCT01783990|141627735|SUPERIORITY|||||||0.87|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.87
71060117|NCT01783990|141627736|SUPERIORITY|||||||0.28|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.28
71060118|NCT01783990|141627737|SUPERIORITY|||||||0.31|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.31
71060119|NCT01783990|141627738|SUPERIORITY|||||||0.04|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.04
71060120|NCT01050530|141627752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51|||<|0.0001|TWO_SIDED|95.0|-2.08|-0.93|||t-test, 2 sided|||||-0.93|-2.08|<0.0001
71060121|NCT01050530|141627753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-300.7||||0.0093|TWO_SIDED|95.0|-526.2|-75.1|||t-test, 2 sided|||||-75.1|-526.2|0.0093
71060122|NCT00276484|141627775|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.3|STANDARD_ERROR_OF_MEAN|1.6|<|0.001||95.0|-19.4|-13.2|||ANCOVA|Model terms: treatment and baseline LDL-C value||||-13.2|-19.4|<0.001
71060123|NCT00276484|141627776|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.8||0.551||95.0|-1.1|2.1|||ANCOVA|Model terms: treatment and baseline HDL-C value||||2.1|-1.1|0.551
71060124|NCT00276484|141627777|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.3|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-17.1|-11.6|||ANCOVA|Model terms: treatment and baseline non-HDL-C value||||-11.6|-17.1|<0.001
71060125|NCT00276484|141627778|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.0|STANDARD_ERROR_OF_MEAN|1.0|<|0.001||95.0|-12.0|-7.9|||ANCOVA|Model terms: treatment and baseline Total-C value||||-7.9|-12.0|<0.001
71060126|NCT00276484|141627779|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-7.3|||<|0.001||95.0|-11.5|-3.1|||Nonparametric ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment and baseline triglycerides value.|The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic.|||-3.1|-11.5|<0.001
71060127|NCT00276484|141627780|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.1|STANDARD_ERROR_OF_MEAN|1.3|<|0.001||95.0|-12.7|-7.6|||ANCOVA|Model terms: treatment and baseline Apo B value||||-7.6|-12.7|<0.001
71060128|NCT00276484|141627781|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.8||0.313||95.0|-0.8|2.5|||ANCOVA|Model terms: treatment and baseline Apo A-I value||||2.5|-0.8|0.313
71060129|NCT00276484|141627782|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|1.1|<|0.001||95.0|-12.6|-8.2|||ANCOVA|Model terms: treatment and baseline Total-C:HDL-C value||||-8.2|-12.6|<0.001
71060130|NCT00276484|141627783|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.5|STANDARD_ERROR_OF_MEAN|1.7|<|0.001||95.0|-19.9|-13.1|||ANCOVA|Model terms: treatment and baseline LDL-C:HDL-C value||||-13.1|-19.9|<0.001
71060131|NCT00276484|141627784|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.0|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-13.8|-8.2|||ANCOVA|Model terms: treatment and baseline Apo B:Apo A-I value||||-8.2|-13.8|<0.001
71060132|NCT00276484|141627785|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.5|STANDARD_ERROR_OF_MEAN|-1.6|<|0.001||95.0|-17.7|-11.3|||ANCOVA|Model terms: treatment and baseline non-HDL-C:HDL-C value||||-11.3|-17.7|<0.001
71060133|NCT00276484|141627786|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.8||||0.174||95.0|-17.1|3.4|||Longitudinal Data Analysis (LDA)|LDA method of Liang and Zeger with model terms: treatment, time, and the interaction of time by treatment.|Data for analysis was transformed by the natural log and the difference in geometric mean % change from BL calculated based on the difference in the back-transformed least squares means.|||3.4|-17.1|0.174
71060134|NCT00276484|141627787|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.37|||<|0.001||95.0|5.45|12.84|||Regression, Logistic|Model terms: treatment and baseline LDL-C value||||12.84|5.45|<0.001
71060135|NCT02440464|141627788|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.10.|Log Rank|||The null hypothesis is that there is no difference in progression-free survival time post-randomization among randomized subjects receiving Ixazomib vs Placebo maintenance therapy during the 21 month period post-randomization. This was compared between treatment arms using a log rank test.||||1.0
71060136|NCT02440464|141627789|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Gray's Test|||The null hypothesis is that there is no difference in the proportions of participants with acute grade III-IV GVHD between the Ixazomib and Placebo arms during 100 days post-randomization, with death prior to acute GVHD treated as a competing risk. Cumulative incidences are compared between treatment arms using Gray's test.||||1.0
71060137|NCT02440464|141627790|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Gray's Test|||The null hypothesis is that there is no difference in the proportions of participants with chronic GVHD between the Ixazomib and Placebo arms during 21 months post-randomization, with death prior to chronic GVHD treated as a competing risk. Cumulative incidences are compared between treatment arms using Gray's test.||||1.0
71060138|NCT02440464|141627791|SUPERIORITY|The null hypothesis is that there is no difference in the proportions of participants in the best response to treatment categories between the Ixazomib and Placebo arms during 2 years post-transplant among participants in sCR/CR at randomization. These proportions were compared using Fisher's Exact test.||||||0.89|||||||Fisher Exact|Statistical significance was determined using a pre-specified one-sided threshold of 0.05.||Participants in sCR/CR at Randomization||||0.890
71060139|NCT02440464|141627791|SUPERIORITY|||||||0.754||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Fisher Exact|||The null hypothesis is that there is no difference in the proportions of participants in the best response to treatment categories between the Ixazomib and Placebo arms during 2 years post-transplant among participants not in sCR/CR at randomization. These proportions were compared using Fisher's Exact test.||||0.754
70936276|NCT00749944|141373014|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.4|1.8|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.8|0.4|
70936277|NCT00749944|141373014|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.4|1.6|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.6|0.4|
70936278|NCT00749944|141373014|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.3|1.6|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.6|0.3|
71060140|NCT02440464|141627793|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Gray's Test|||The null hypothesis is that there is no difference in the proportions of participants with progression between the Ixazomib and Placebo arms during 21 months post-randomization, with death prior to progression treated as a competing risk. Cumulative incidences are compared between treatment arms using Gray's test.||||1.0
70936279|NCT00749944|141373014|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.4|1.8|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.8|0.4|
70936280|NCT00749944|141373014|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.4|1.7|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.7|0.4|
70936281|NCT00749944|141373015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.3|2.3|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.3|0.3|
70936282|NCT00749944|141373015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.4|1.9|||||Cochran-Mantel-Haenszel|Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.9|0.4|
71060141|NCT02440464|141627794|SUPERIORITY|||||||0.174||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Log Rank|||The null hypothesis is that there is no difference in overall survival time post-randomization among randomized subjects receiving Ixazomib vs Placebo maintenance therapy during the 21 month period post-randomization. This was compared between treatment arms using a log rank test.||||0.174
71060142|NCT02440464|141627795|SUPERIORITY|||||||0.173||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Gray's Test|||The null hypothesis is that there is no difference in the proportions of participants with treatment-related mortality between the Ixazomib and Placebo arms during 21 months post-randomization, with progression treated as a competing risk. Cumulative incidences are compared between treatment arms using Gray's test.||||0.173
70936283|NCT00749944|141373015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.4|2.2|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.2|0.4|
71060143|NCT02440464|141627797|SUPERIORITY|||||||0.258||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Z test|||The null hypothesis is that there is no difference in the proportions of participants with Grade 3-5 toxicities between the Ixazomib and Placebo arms during 6 months post-randomization, with death from a cause other than toxicity treated as a competing risk. Cumulative incidences are estimated at 6, 12 and 18 months post randomization using Aalen-Johansen estimators for each treatment group. Comparison of cumulative incidence between treatment arms was done using a Z test at fixed time points.||||0.258
71060144|NCT02440464|141627797|SUPERIORITY|||||||0.252||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Z test|||The null hypothesis is that there is no difference in the proportions of participants with Grade 3-5 toxicities between the Ixazomib and Placebo arms during 12 months post-randomization, with death from a cause other than toxicity treated as a competing risk. Cumulative incidences are estimated at 6, 12 and 18 months post randomization using Aalen-Johansen estimators for each treatment group. Comparison of cumulative incidence between treatment arms was done using a Z test at fixed time points.||||0.252
71109634|NCT02722408|141724371|OTHER|||||||0.0089||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0089
70936284|NCT00749944|141373015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.5|2.6|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.6|0.5|
70936285|NCT00749944|141373015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.5|2.3|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.3|0.5|
70936286|NCT00749944|141373015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.6|2.7|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.7|0.6|
70936287|NCT00749944|141373015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.5|2.8|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.8|0.5|
70936288|NCT00749944|141373017|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.0|5.6|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.6|0.0|
70936289|NCT00749944|141373017|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.0|5.6|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.6|0.0|
71060145|NCT02440464|141627797|SUPERIORITY|||||||0.258||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Z test|||The null hypothesis is that there is no difference in the proportions of participants with Grade 3-5 toxicities between the Ixazomib and Placebo arms during 18 months post-randomization, with death from a cause other than toxicity treated as a competing risk. Cumulative incidences are estimated at 6, 12 and 18 months post randomization using Aalen-Johansen estimators for each treatment group. Comparison of cumulative incidence between treatment arms was done using a Z test at fixed time points.||||0.258
71060146|NCT02440464|141627799|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Z test|||The null hypothesis is that there is no difference in the proportions of participants with Grade 3 infections between the Ixazomib and Placebo arms during 6 months post-randomization, with death from a cause other than infection treated as a competing risk. Cumulative incidences are estimated at 6, 12 and 18 months post randomization using Aalen-Johansen estimators for each treatment group. Comparison of cumulative incidence between treatment arms was done using a Z test at fixed time points.||||1.0
71060147|NCT02440464|141627799|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Z test|||The null hypothesis is that there is no difference in the proportions of participants with Grade 3 infections between the Ixazomib and Placebo arms during 12 months post-randomization, with death from a cause other than infection treated as a competing risk. Cumulative incidences are estimated at 6, 12 and 18 months post randomization using Aalen-Johansen estimators for each treatment group. Comparison of cumulative incidence between treatment arms was done using a Z test at fixed time points.||||1.0
71060148|NCT02440464|141627799|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Z test|||The null hypothesis is that there is no difference in the proportions of participants with Grade 3 infections between the Ixazomib and Placebo arms during 18 months post-randomization, with death from a cause other than infection treated as a competing risk. Cumulative incidences are estimated at 6, 12 and 18 months post randomization using Aalen-Johansen estimators for each treatment group. Comparison of cumulative incidence between treatment arms was done using a Z test at fixed time points.||||1.0
71060149|NCT04688671|141627802|SUPERIORITY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.302||0.5605|TWO_SIDED|90.0|-0.32|0.68|||Mixed Models Analysis|||||0.68|-0.32|0.5605
71060150|NCT01525329|141627820|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.007|||||||t-test, 2 sided|||||||< 0.007
70936290|NCT00749944|141373017|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.3|3.6|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||3.6|0.3|
71060151|NCT01525329|141627820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08|||||||t-test, 2 sided|||||||0.080
71060152|NCT01525329|141627821|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71060153|NCT01525329|141627821|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71060154|NCT04055740|141627823|SUPERIORITY|||||||0.2201|||||||Spearman Correlation Coefficient|This test measures correlation of avg ILA grade per patient with total time of lead extraction. Average ILA grade of all patients in outcome measures.||H0: rho = 0 Spearman correlation coefficient calculated between average ILA grade and total time of lead extraction||||0.2201
71060155|NCT04055740|141627823|SUPERIORITY|||||||0.5157|||||||Spearman Correlation Coefficient|This measures correlation of avg ILA grade per patient with total laser pulsations used for extraction. Avg ILA grade of patients in outcome measures.||H0: rho = 0 Spearman Correlation coefficient calculated between average ILA grades and laser pulsations||||0.5157
71060156|NCT02414958|141627825|SUPERIORITY||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|97.5|-0.66|-0.41|||Mixed effect Model Repeated Measures||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model Mixed effect Model Repeated Measures (MMRM) included the fixed categorical effects of treatment, pre-existing insulin therapy, visit , and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline HbA1c, baseline estimated glomerular filtration rate (eGFR), and baseline HbA1c-by- visit interaction. Patient was included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.41|-0.66|<0.0001
71060157|NCT02414958|141627825|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|97.5|-0.66|-0.41|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean|Model MMRM included the fixed categorical effects of treatment, pre-existing insulin therapy, visit, and treatment-by- visit interaction, as well as the continuous, fixed covariates of baseline HbA1c, baseline eGFR, and baseline HbA1c-by- visit interaction. Patient was included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.41|-0.66|<0.0001
71109635|NCT02722408|141724371|OTHER|||||||0.0013||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0013
71109636|NCT02722408|141724371|OTHER|||||||0.0019||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0019
71109637|NCT02722408|141724372|OTHER|||||||0.9195||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.9195
71060158|NCT02414958|141627826|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|97.5|-0.65|-0.4|||MMRM||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.40|-0.65|<0.0001
71060159|NCT02414958|141627826|SUPERIORITY||Mean Difference (Final Values)|-0.51|||<|0.0001|TWO_SIDED|97.5|-0.64|-0.39|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements||-0.39|-0.64|<0.0001
71060160|NCT02414958|141627827|SUPERIORITY||Adjusted Rate Ratio (%)|0.744||||0.0623|TWO_SIDED|97.75|0.518|1.069|||Negative binomial model||Empagliflozin 10 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For week 5 to 26, negative binomial model includes baseline rate of hypoglycaemia, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.069|0.518|0.0623
71060161|NCT02414958|141627827|SUPERIORITY||Adjusted Rate Ratio (%)|0.726||||0.048|TWO_SIDED|97.75|0.502|1.501|||Negative binomial model||Empagliflozin 25 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For week 5 to 26, negative binomial model includes baseline rate of hypoglycaemia, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset||1.501|0.502|0.0480
71060162|NCT02414958|141627827|SUPERIORITY||Adjusted Rate Ratio (%)|0.774||||0.0972|TWO_SIDED|95.0|0.572|1.048||This is a nominal p-value.|Negative binomial model||Empagliflozin 10 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For week 1 to 26, negative binomial model includes baseline rate of hypoglycaemia, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.048|0.572|0.0972
71060163|NCT02414958|141627827|SUPERIORITY||Adjusted Rate Ratio (%)|0.782||||0.118|TWO_SIDED|97.75|0.575|1.064||Negative binomial model|MMRM||Empagliflozin 25 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For week 1 to 26, negative binomial model includes baseline rate of hypoglycaemia, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.064|0.575|0.1180
71060164|NCT02414958|141627828|SUPERIORITY||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|99.75|-3.57|-1.8|||MMRM||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline weight, baseline eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline weight by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-1.80|-3.57|<0.0001
71060165|NCT02414958|141627828|SUPERIORITY||Mean Difference (Final Values)|-3.27|||<|0.0001|TWO_SIDED|99.75|-4.15|-2.39|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline weight, baseline eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline weight by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-2.39|-4.15|<0.0001
71060166|NCT02414958|141627829|SUPERIORITY||Mean Difference (Final Values)|11.86|||<|0.0001|TWO_SIDED|99.75|8.78|14.93|||ANCOVA||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean|The analysis of covariance (ANCOVA) model includes baseline time in the target range, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects.||14.93|8.78|<0.0001
71060167|NCT02414958|141627829|SUPERIORITY||Mean Difference (Final Values)|12.87|STANDARD_ERROR_OF_MEAN|1.01|<|0.0001|TWO_SIDED|99.75|9.81|15.93|||ANCOVA||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean|||15.93|9.81|<0.0001
71060168|NCT02414958|141627830|SUPERIORITY||Mean Difference (Final Values)|-16.92|STANDARD_ERROR_OF_MEAN|1.68|<|0.0001|TWO_SIDED|99.75|-22.04|-11.81|||ANCOVA||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|The analysis of covariance (ANCOVA) model includes model includes baseline IQR of glucose, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects.||-11.81|-22.04|<0.0001
71060169|NCT02414958|141627830|SUPERIORITY||Mean Difference (Final Values)|-19.04|STANDARD_ERROR_OF_MEAN|1.68|<|0.0001|TWO_SIDED|99.75|-24.13|-13.95|||ANCOVA||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|The analysis of covariance (ANCOVA) model includes model includes baseline IQR of glucose, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects.||-13.95|-24.13|<0.0001
71060170|NCT02414958|141627831|SUPERIORITY||Mean Difference (Final Values)|-0.092|STANDARD_ERROR_OF_MEAN|0.009|<|0.0001|TWO_SIDED|99.75|-0.121|-0.063|||MMRM||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline total daily insulin dose, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline total daily insulin dose by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.063|-0.121|<0.0001
71109638|NCT02722408|141724372|OTHER|||||||0.7497||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.7497
71109639|NCT02722408|141724372|OTHER|||||||0.5056||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.5056
71109640|NCT02722408|141724372|OTHER|||||||0.2468||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.2468
71109641|NCT02722408|141724372|OTHER|||||||0.392||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.3920
71060171|NCT02414958|141627831|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.009|<|0.0001|TWO_SIDED|99.75|-0.119|-0.062|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline total daily insulin dose, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline total daily insulin dose by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.062|-0.119|<0.0001
71060172|NCT02414958|141627832|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|1.0||0.0397|TWO_SIDED|99.75|-5.2|1.0|||MMRM||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For SBP, the model MMRM includes baseline SBP seated, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline SBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||1.0|-5.2|0.0397
71060173|NCT02414958|141627832|SUPERIORITY||Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|1.0||0.0003|TWO_SIDED|99.75|-6.8|-0.6|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For SBP, the model includes baseline SBP seated, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline SBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.6|-6.8|0.0003
71060174|NCT02414958|141627832|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.7||0.0457|TWO_SIDED|99.75|-2.7|0.0||Nominal p-value|MMRM||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For DBP, the model MMRM includes baseline DBP seated, baseline eGFR baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline DBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||0.0|-2.7|0.0457
71060175|NCT02414958|141627832|SUPERIORITY||Mean Difference (Final Values)|-2.3|STANDARD_ERROR_OF_MEAN|0.7||0.0006|TWO_SIDED|99.75|-4.3|-0.3|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For DBP, the model MMRM includes baseline DBP seated, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline DBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.3|-4.3|0.0006
71060176|NCT05767905|141627834|OTHER||ratio|108.49|||||TWO_SIDED|90.0|100.55|117.05|||Mixed Models Analysis|"Mixed Model was fitted to obtain:~1.Ratio of geometric means 2.90% CI of ratio of geometric means"||Part 1 PF-06821497 Form 1 250 mg Fasted was the Reference treatment and Part 1 PF-06821497 Form 3 250 mg Fasted was the Test treatment.||117.05|100.55|
71060177|NCT05767905|141627834|OTHER||ratio|106.16|||||TWO_SIDED|90.0|98.39|114.54|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 1 PF-06821497 Form 3 250 mg Fasted was the Test treatment and Part 1 PF-06821497 Form 2 250 mg Fasted was the Reference treatment.||114.54|98.39|
71060178|NCT05767905|141627834|OTHER||ratio|228.99|||||TWO_SIDED|90.0|178.67|293.48|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 2 PF-06821497 Form 2 1250 mg Fed High-fat was the Test treatment and Part 2 PF-06821497 Form 2 1250 mg Fasted was the Reference treatment.||293.48|178.67|
71060179|NCT05767905|141627834|OTHER||ratio|207.19|||||TWO_SIDED|90.0|164.41|261.09||||||Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat was the Test treatment and Part 2 PF-06821497 Form 2 1250 mg Fasted was the Reference treatment.||261.09|164.41|
71060180|NCT05767905|141627834|OTHER||ratio|102.19|||||TWO_SIDED|90.0|95.55|109.3|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 1 PF-06821497 Form 1 250 mg Fasted was the Reference treatment, and Part 1 PF-06821497 Form 2 250 mg Fasted was the Test treatment||109.30|95.55|
71060181|NCT05767905|141627835|OTHER||ratio|145.49|||||TWO_SIDED|90.0|121.29|174.53|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 1 PF-06821497 Form 3 250 mg Fasted was the Test treatment and Part 1 PF-06821497 Form 1 250 mg Fasted was the Reference treatment.||174.53|121.29|
70936291|NCT00749944|141373017|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.0|5.7|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.7|0.0|
71060182|NCT05767905|141627835|OTHER||ratio|122.64|||||TWO_SIDED|90.0|102.24|147.12|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 1 PF-06821497 Form 3 250 mg Fasted was the Test treatment and Part 1 PF-06821497 Form 2 250 mg Fasted was the Reference treatment.||147.12|102.24|
71060183|NCT05767905|141627835|OTHER||ratio|284.72|||||TWO_SIDED|90.0|226.39|358.06|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat was the Test treatment and Part 2 PF-06821497 Form 2 1250 mg Fasted was the Reference treatment.||358.06|226.39|
71060184|NCT05767905|141627835|OTHER||ratio|327.87|||||TWO_SIDED|90.0|256.9|418.44|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 2 PF-06821497 Form 2 1250 mg Fed High-fat was the Test treatment and Part 2 PF-06821497 Form 2 1250 mg Fasted was the Reference treatment.||418.44|256.90|
70936292|NCT00749944|141373017|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.0|5.7|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.7|0.0|
70936293|NCT00749944|141373017|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.3|3.7|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||3.7|0.3|
70936294|NCT00749944|141373018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||||TWO_SIDED|95.0|0.2|23.6|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||23.6|0.2|
70936295|NCT01393600|141373052|OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|1.3||0.588|TWO_SIDED|95.0|-3.3|1.9|||ANOVA|||||1.9|-3.3|0.5880
70936296|NCT01393600|141373052|OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|1.3||0.4184|TWO_SIDED|95.0|-3.8|1.6|||ANOVA|||||1.6|-3.8|0.4184
70936297|NCT01393600|141373054|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.0||0.6761|TWO_SIDED|95.0|-2.4|1.6|||ANOVA|||||1.6|-2.4|0.6761
70936298|NCT01393600|141373054|OTHER||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|1.1||0.0015|TWO_SIDED|95.0|-6.6|-1.8|||ANOVA|||||-1.8|-6.6|0.0015
70936299|NCT00508183|141373061|OTHER|||||||0.6|||||||t-test, 2 sided|||||||0.60
71060185|NCT05767905|141627835|OTHER||ratio|118.63|||||TWO_SIDED|90.0|96.36|146.06|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 1 PF-06821497 Form 1 250 mg Fasted was the Reference treatment, and Part 1 PF-06821497 Form 2 250 mg Fasted was the Test treatment.||146.06|96.36|
71060186|NCT03762239|141627839|SUPERIORITY||Relative (percent) changes in the median|1.37||||0.52|TWO_SIDED|95.0|-2.81|5.56|||Conditional linear regression|Class group as strata. Adjusted for year of birth, sex as well as average temperature, relative humidity and CO2 concentration during the experiment.|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in better performance, relative to the classroom without air filter (normal air), in attention measures among adolescents in high schools.||5.56|-2.81|0.52
71060187|NCT03762239|141627840|SUPERIORITY||Beta coefficient|0.013||||0.72|TWO_SIDED|95.0|-0.0607|0.0865|||Regression, Linear|Using multiple imputation by chained equations. Adjusted for a rich set or relevant controls. Standard errors clustered at the high school level.|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in higher riskloving behavior, relative to the classroom without air filter (normal air), in the combined risk taking measures among adolescents in high schools.||0.0865|-0.0607|0.72
71060188|NCT03762239|141627841|SUPERIORITY||Beta coefficient|-0.029||||0.5|TWO_SIDED|95.0|-0.117|0.0584|||Regression, Linear|Using multiple imputation by chained equations. Adjusted for a rich set or relevant controls. Standard errors clustered at the high school level|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in higher level of patience, relative to the classroom without air filter (normal air), in the combined patience measures among adolescents in high schools.||0.0584|-0.1170|0.50
71109642|NCT02722408|141724372|OTHER|||||||0.4456||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.4456
70936300|NCT00508183|141373062|OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.05
71109643|NCT02722408|141724372|OTHER|||||||0.9203||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.9203
71109644|NCT02722408|141724372|OTHER|||||||0.9704||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.9704
71109645|NCT02722408|141724372|OTHER|||||||0.9755||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.9755
70936301|NCT00508183|141373063|OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.05
70936302|NCT00508183|141373065|OTHER|||||||0.05|||||||Chi-squared|||||||0.05
70936303|NCT01762982|141373104|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0654||95.0|||||Signed Rank Test|||Null hypothesis considered no treatment difference between the treatments being compared.||||0.0654
70936304|NCT01762982|141373107|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0078||95.0|||||Signed Rank Test|||Null hypothesis considered no treatment difference between the treatments being compared.||||0.0078
70936305|NCT01762982|141373108|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0547||95.0|||||Signed Rank Test|||Null hypothesis considered no treatment difference between the treatments being compared.||||0.0547
70936306|NCT01029704|141373116|SUPERIORITY||Difference of LS Means|-16.923||||0.0989|TWO_SIDED|95.0|-37.076|3.23||P-values are from two-sided test at 5% level|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||3.230|-37.076|0.0989
70936307|NCT01029704|141373116|SUPERIORITY||Difference of LS Means|-17.834||||0.0964|TWO_SIDED|95.0|-38.909|3.242||P-values are from two-sided test at 5% level|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||3.242|-38.909|0.0964
70936308|NCT01029704|141373116|SUPERIORITY||Difference of LS Means|-19.991||||0.0465|TWO_SIDED|95.0|-39.67|-0.312||P-values are from two-sided test at 5% level|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-0.312|-39.670|0.0465
70936309|NCT01029704|141373116|SUPERIORITY||Difference of LS Means|-32.01||||0.0015|TWO_SIDED|95.0|-51.487|-12.533||P-values are from two-sided test at 5% level|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-12.533|-51.487|0.0015
71060189|NCT03762239|141627842|SUPERIORITY||Beta coefficient|0.06||||0.13|TWO_SIDED|95.0|-0.0184|0.1394|||Regression, Linear|Using multiple imputation by chained equations. Adjusted for a rich set or relevant controls. Standard errors clustered at the high school level.|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in higher level of positive reciprocity behavior, relative to the classroom without air filter (normal air), in the positive reciprocity measures among adolescents in high schools||0.1394|-0.0184|0.13
71060190|NCT03762239|141627843|SUPERIORITY||Beta coefficient|0.022||||0.58|TWO_SIDED|95.0|-0.0595|0.1035|||Regression, Linear|Using multiple imputation by chained equations. Adjusted for a rich set or relevant controls. Standard errors clustered at the high school level.|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in higher Altruism behavior, relative to the classroom without air filter (normal air), in the Altruism measures among adolescents in high schools.||0.1035|-0.0595|0.58
71060191|NCT03762239|141627844|SUPERIORITY||Beta coefficient|0.013||||0.89|TWO_SIDED|95.0|-0.1786|0.2049|||Ordered logistic regression|Using multiple imputation by chained equations. Adjusted for a rich set or relevant controls. Standard errors clustered at the high school level.|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in higher trust, relative to the classroom without air filter (normal air), in the subjective trust measure among adolescents in high schools.||0.2049|-0.1786|0.89
71060192|NCT03762239|141627845|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.5|TWO_SIDED|95.0|-0.49|0.24|||Conditional linear regression|Class group as strata. Adjusted for year of birth, sex as well as average temperature, relative humidity and CO2 concentration during the experiment.|Change comparing the filter group to the non-filter group|||0.24|-0.49|0.50
71060193|NCT03762239|141627846|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.47|TWO_SIDED|95.0|-0.2|0.1|||Conditional linear regression|Class group as strata. Adjusted for year of birth, sex as well as average temperature, relative humidity and CO2 concentration during the experiment.|Change comparing the filter group to the non-filter group|||0.10|-0.20|0.47
71060194|NCT03762239|141627847|SUPERIORITY||Mean Difference (Final Values)|-3.38||||0.2|TWO_SIDED|95.0|-8.51|1.74|||Conditional linear regression|Class group as strata. Adjusted for year of birth, sex as well as average temperature, relative humidity and CO2 concentration during the experiment.||||1.74|-8.51|0.20
71060195|NCT03762239|141627848|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.92|TWO_SIDED|95.0|-5.1|4.6|||Conditional linear regression|Class group as strata. Adjusted for year of birth, sex as well as average temperature, relative humidity and CO2 concentration during the experiment.||||4.60|-5.10|0.92
71060196|NCT03762239|141627849|SUPERIORITY||Mean Difference (Final Values)|-1.36||||0.46|TWO_SIDED|95.0|-4.94|2.22|||Conditional linear regression|Class group as strata. Adjusted for year of birth, sex as well as average temperature, relative humidity and CO2 concentration during the experiment.||||2.22|-4.94|0.46
71060197|NCT03762239|141627850|SUPERIORITY||Beta coefficient|-0.1446||||0.232|TWO_SIDED|95.0|-0.382|0.0928|||Ordered logistic regression|Adjusted for a rich set or relevant controls. Standard errors clustered at the high school level.|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in higher assessment of math skills, relative to the classroom without air filter (normal air), in the self assessed math skills measure among adolescents in high schools.||0.0928|-0.3820|0.232
71060198|NCT04660331|141627882|OTHER||||||||||||||||||2-sided t-test conducted for pre- and post-training results.|||
71060199|NCT04660331|141627883|OTHER||||||||||||||||||We grouped pharmacy data on vaccines delivered pre/post intervention into six categories: HPV vaccine, Tdap, Meningococcal, Influenza, COVID-19, and other vaccines. We then compared the counts of total vaccines that were conducted in each group pre- and post-training.|||
71060200|NCT04660331|141627884|OTHER||||||||||||||||||We grouped pharmacy data on vaccines delivered pre/post intervention into six categories: HPV vaccine, Tdap, Meningococcal, Influenza, COVID-19, and other vaccines. We then compared the counts of total vaccines that were conducted in each group pre- and post-training.|||
71060201|NCT02635984|141627885|SUPERIORITY|||||||0.003|||||||Chi-squared|||Based on an 80 % power and an alpha of 0.05, we estimated a need for 49 patients in each treatment arm. From a review of existing literature, the sample size was based on an estimated CR achieved in 65 % of patients on triplet therapy alone and a hypothesized clinically relevant increase of 25 % for the treatment group to 90 %.||||0.003
71060202|NCT02635984|141627886|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
71060203|NCT02635984|141627887|SUPERIORITY|||||||0.11|||||||Chi-squared|||||||0.11
71060204|NCT02635984|141627888|SUPERIORITY|||||||0.28|||||||Chi-squared|||||||0.28
71060205|NCT02635984|141627889|SUPERIORITY|||||||0.002|||||||Chi-squared|||||||0.002
71060206|NCT02635984|141627890|SUPERIORITY|||||||0.006|||||||Chi-squared|||||||0.006
71060207|NCT02635984|141627891|SUPERIORITY|||||||0.13|||||||Chi-squared|||||||0.13
71060208|NCT02635984|141627892|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
71060209|NCT01776632|141627898|SUPERIORITY||difference of adjusted means|0.15||||0.03|TWO_SIDED||||||generalized linear mixed effects|||||||.03
71109646|NCT02722408|141724372|OTHER|||||||0.4213||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.4213
71109647|NCT02722408|141724372|OTHER|||||||0.03||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0300
71109648|NCT02722408|141724372|OTHER|||||||0.03||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0300
71060210|NCT01776632|141627899|SUPERIORITY||difference of adjusted means|0.39||||0.003|TWO_SIDED||||||generalized linear mixed effects|||||||.003
71060211|NCT01776632|141627900|SUPERIORITY||difference of adjusted means|-0.43||||0.04|TWO_SIDED||||||mixed effects models|||||||.04
70936310|NCT01029704|141373118|SUPERIORITY||Difference of LS Means|-1.434||||0.0025|TWO_SIDED|95.0|-2.349|-0.52||P-values are from a two-sided test.|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-0.520|-2.349|0.0025
70936311|NCT01029704|141373118|SUPERIORITY||Difference of LS Means|-1.037||||0.0269|TWO_SIDED|95.0|-1.952|-0.122||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-0.122|-1.952|0.0269
70936312|NCT01029704|141373118|SUPERIORITY||Difference of LS Means|-2.054|||<|0.0001|TWO_SIDED|95.0|-2.938|-1.17||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-1.170|-2.938|< 0.0001
70936313|NCT01029704|141373118|SUPERIORITY||Difference of LS Means|-1.172||||0.009|TWO_SIDED|95.0|-2.044|-0.301||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-0.301|-2.044|0.0090
70936314|NCT01029704|141373119|SUPERIORITY||Difference of LS Means|-0.353||||0.0281|TWO_SIDED|95.0|-0.668|-0.039||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-0.039|-0.668|0.0281
70936315|NCT01029704|141373119|SUPERIORITY||Difference of LS Means|-0.155||||0.3215|TWO_SIDED|95.0|-0.464|0.154||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||0.154|-0.464|0.3215
70936316|NCT01029704|141373119|SUPERIORITY||Difference of LS Means|-0.004||||0.9776|TWO_SIDED|95.0|-0.304|0.295||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||0.295|-0.304|0.9776
70936317|NCT01029704|141373119|SUPERIORITY||Difference of LS Means|-0.344||||0.0242|TWO_SIDED|95.0|-0.642|-0.046||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-0.046|-0.642|0.0242
70936318|NCT01029704|141373121|SUPERIORITY||Difference of LS Means|17.688||||0.1613|TWO_SIDED|95.0|-7.21|42.587||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||42.587|-7.210|0.1613
70936319|NCT01029704|141373121|SUPERIORITY||Difference of LS Means|17.091||||0.2079|TWO_SIDED|95.0|-9.696|43.877||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||43.877|-9.696|0.2079
70936320|NCT01029704|141373121|SUPERIORITY||Difference of LS Means|24.379||||0.041|TWO_SIDED|95.0|1.028|47.731||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||47.731|1.028|0.0410
70936321|NCT01029704|141373121|SUPERIORITY||Difference of LS Means|20.749||||0.0862|TWO_SIDED|95.0|-3.019|44.518||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||44.518|-3.019|0.0862
70936322|NCT00089791|141373128|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.32|||<|0.0001||95.0|0.26|0.41||Logistic regression was used to generate the p-value|Mantel Haenszel|||||0.41|0.26|<0.0001
71060212|NCT01776632|141627901|SUPERIORITY||difference of adjusted means|-1.27||||0.09|TWO_SIDED||||||mixed effects models|||||||.09
71060213|NCT00708110|141627906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|||<|0.001|TWO_SIDED|95.0|-2.0|-1.07|||ANCOVA|||||-1.07|-2.00|<0.001
70936323|NCT00089791|141373129|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8||||0.0106||95.0|0.67|0.95|||Regression, Cox|||||0.95|0.67|0.0106
70936324|NCT00089791|141373130|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6||||0.0362||95.0|0.37|0.97|||Regression, Cox|||||0.97|0.37|0.0362
70936325|NCT01137682|141373140|SUPERIORITY||Odds Ratio (OR)|16.63||||0.0006|TWO_SIDED|95.0|3.32||infinity||Regression, Logistic|An exact logistic regression model that adjusts for the randomization stratification factors was used to test the null hypothesis.|||||3.32|0.0006
70936326|NCT01137682|141373140|SUPERIORITY||Odds Ratio (OR)|23.03|||<|0.0001|TWO_SIDED|95.0|4.72||infinity||Regression, Logistic|An exact logistic regression model that adjusts for the randomization stratification factors was used to test the null hypothesis.|||||4.72|<0.0001
70936327|NCT00721734|141373158|SUPERIORITY_OR_OTHER||Slope|-0.607||||0.4114|TWO_SIDED|95.0|-2.129|0.914|||Regression, Linear|||"In order to estimate a possible effect of renal function, the relationship between the clearance of carfilzomib and creatinine clearance (CrCl) was explored using a mixed-effects model that included CrCl.~The slope of the regression of CL as a function of CrCL at Cycle 1, Day 1 was evaluated using a linear regression model that included CrCL as continuous variables (excluding the hemodialysis group)."||0.914|-2.129|0.4114
70936328|NCT04492475|141373203|SUPERIORITY||Cox Proportional Hazard|0.99||||0.88|TWO_SIDED|95.0|0.87|1.13|||Log Rank|||||1.13|0.87|0.880
70936329|NCT04492475|141373220|SUPERIORITY||Risk Difference (RD)|7.2|||||TWO_SIDED|95.0|0.9|13.4||||||||13.4|0.9|
70936330|NCT04492475|141373220|SUPERIORITY||Risk Difference (RD)|23.6|||||TWO_SIDED|95.0|0.0|43.9||||||||43.9|0.0|
70936331|NCT04492475|141373221|SUPERIORITY||Risk Difference (RD)|1.4|||||TWO_SIDED|95.0|-3.2|6.0||||||||6.0|-3.2|
71060214|NCT00708110|141627906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04|||<|0.001|TWO_SIDED|95.0|-2.52|-1.55|||ANCOVA|||||-1.55|-2.52|<0.001
71060215|NCT00708110|141627906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.48|||<|0.001|TWO_SIDED|95.0|-2.94|-2.02|||ANCOVA|||||-2.02|-2.94|<0.001
71109649|NCT02722408|141724378|OTHER|||||||0.0294||||||Mixed-effects model for repeated measures analysis with percent change in hsCRP as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300mg: Day 28||||0.0294
71109650|NCT02722408|141724378|OTHER|||||||0.3228||||||Mixed-effects model for repeated measures analysis with percent change in hsCRP as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.3228
71060216|NCT00951496|141627934|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Study was designed to provide 80% power when arm II reduces the progression free survival event rate 20%. The critical p-value accounts for correlation between 2 primary hypotheses.|Hazard Ratio (HR)|0.94||||0.341|TWO_SIDED|95.0|0.81|1.09||P value not adjusted for multiplicity. Significance Threshold = 0.027|Log Rank|Stratified by stage of disease and size of residual disease.|Progression free survival of arm II relative to arm I. Adjusted for stage of disease and residual size.|P value.(an P value is used to determine statistical significance in a hypothesis test). from a stratified log rank test to assess equality of progression free survival hazards of arm II and arm I||1.09|0.81|0.341
71060217|NCT00951496|141627934|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Study was designed to provide 80% power when arm III reduced the true progression free survival event rate. 20% compared to arm I. Critical p value accounts for correlation between 2 primary hypotheses.|Hazard Ratio (HR)|0.99||||0.587|TWO_SIDED|95.0|0.86|1.15||P value not adjusted for multiplicity. Significance threshold = 0.027 accounting for 2 correlated primary hypotheses.|Log Rank|Stratified by stage of disease and size of residual disease.|Progression free survival hazard of arm III to arm I. Adjusted for stage of disease and residual disease size.|P value from a log rank test comparing the progression free survival hazards of arm III to arm I.||1.15|0.86|0.587
71060218|NCT02273388|141627955|OTHER||Difference of adjusted means|-4.56|STANDARD_ERROR_OF_MEAN|3.61|||TWO_SIDED|90.0|-10.59|1.48|||||Comparison vs. 1 hour infusion \[2h-1h\]|Change from baseline to 5 minutes before infusion end. Linear mixed model with sequence, course, treatment (both infusion types i.e. 1 hour duration and 2 hour duration) and time as fixed effects and treatment\*time as interaction effect, as well as the continuous , fixed covariate of baseline value.||1.48|-10.59|
71060219|NCT02273388|141627955|OTHER||Difference of adjusted means|-7.14|STANDARD_ERROR_OF_MEAN|3.61|||TWO_SIDED|90.0|-13.18|-1.11|||||Comparison vs. 1hour infusion \[2h-1h\]|Change from baseline to 1 hour after infusion end. Linear mixed model with sequence, course, treatment (both infusion types i.e. 1 hour duration and 2 hour duration) and time as fixed effects and treatment\*time as interaction effect, as well as the continuous , fixed covariate of baseline value.||-1.11|-13.18|
71060220|NCT02273388|141627955|OTHER||Difference of adjusted means|-3.58|STANDARD_ERROR_OF_MEAN|3.61|||TWO_SIDED|90.0|-9.61|2.46|||||Comparison vs. 1 hour infusion \[2h-1h\]|Change from baseline to 4 hours after infusion start. Linear mixed model with sequence, course, treatment (both infusion types i.e. 1 hour duration and 2 hour duration) and time as fixed effects and treatment\*time as interaction effect, as well as the continuous , fixed covariate of baseline value.||2.46|-9.61|
71060221|NCT02273388|141627955|OTHER||Difference of adjusted means|-8.66|STANDARD_ERROR_OF_MEAN|3.61|||TWO_SIDED|90.0|-14.7|-2.63|||||Comparison vs. 1 hour \[2h-1h\]|Change from baseline to 24 hours after infusion start. Linear mixed model with sequence, course, treatment (both infusion types i.e. 1 hour duration and 2 hour duration) and time as fixed effects and treatment\*time as interaction effect, as well as the continuous , fixed covariate of baseline value.||-2.63|-14.70|
71060222|NCT03281876|141628005|OTHER|Vaccine Efficacy is defined as 1 minus the risk ratio (Rvacc / Rcon) based on the number of moderate and severe AECOPD observed in 1 year , with Rvacc = average yearly incidence rate of AECOPD events per subject in the GSK3277511A Group and Rcon = average yearly incidence rate of AECOPD events per subject in the Control group. The objective is to be considered a success if the lower limit of the 87% CI is above 0%.|Other: Vaccine Efficacy rate|-2.26||||0.8157|TWO_SIDED|87.0|-18.27|11.58|||Negative Binomial regression|Negative Binomial model with arm, country, gold grade, history of exacerbation and age category as covariates and log time as offset variable||To assess efficacy of the investigational vaccine as compared to the placebo control with respect to the rate of moderate and severe AECOPDs||11.58|-18.27|0.8157
71060223|NCT03281876|141628006|OTHER|Vaccine Efficacy is defined as 1 minus the risk ratio (Rvacc / Rcon) based on the number of moderate and severe AECOPD observed in 1 year , with Rvacc = average yearly incidence rate of AECOPD events per subject in the GSK3277511A Group and Rcon = average yearly incidence rate of AECOPD events per subject in the Control group.|Other: Vaccine Efficacy rate|-2.26||||0.8157|TWO_SIDED|95.0|-23.45|15.29|||Negative Binomial regression|Negative Binomial model with arm, country, gold grade, history of exacerbation and age category as covariates and log time as offset variable||To assess efficacy of the investigational vaccine as compared to the placebo control with respect to the rate of moderate and severe AECOPDs||15.29|-23.45|0.8157
71060224|NCT03281876|141628013|OTHER|Vaccine Efficacy is defined as 1 minus the risk ratio (Rvacc / Rcon) based on the number of moderate and severe AECOPD observed in 1 year , with Rvacc = average yearly incidence rate of AECOPD events per subject in the GSK3277511A Group and Rcon = average yearly incidence rate of AECOPD events per subject in the control group.|Vaccine efficacy rate|-2.72||||0.77|TWO_SIDED|95.0|-22.95|14.19|||Negative Binomial regression|||To assess efficacy of the investigational vaccine as compared to the placebo control with respect to the rate of AECOPDs of any severity- upto 12 months follow up period||14.19|-22.95|0.7700
71060225|NCT03281876|141628015|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|0.94||||0.5751|TWO_SIDED|95.0|0.758|1.166|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for moderate or severe AECOPDs, one year follow-up starting 1 month post dose 2||1.166|0.758|0.5751
71060226|NCT03281876|141628016|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|0.934||||0.5194|TWO_SIDED|95.0|0.758|1.15|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for any AECOPDs, one year follow-up starting 1 month post dose 2||1.15|0.758|0.5194
71060227|NCT03281876|141628017|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|1.05||||0.8581|TWO_SIDED|95.0|0.616|1.791|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for mild AECOPDs, one year follow-up starting 1 month post dose 2||1.791|0.616|0.8581
70936332|NCT04492475|141373221|SUPERIORITY||Risk Difference (RD)|35.8|||||TWO_SIDED|95.0|12.3|54.2||||||||54.2|12.3|
70936333|NCT04492475|141373245|SUPERIORITY||Cox Proportional Hazard|1.04|||||TWO_SIDED|95.0|0.9|1.19||||||||1.19|0.90|
70936334|NCT04492475|141373245|SUPERIORITY||Cox Proportional Hazard|0.37|||||TWO_SIDED|95.0|0.21|0.66||||||||0.66|0.21|
70936335|NCT04492475|141373246|SUPERIORITY||Cox Proportional Hazard|1.04|||||TWO_SIDED|95.0|0.91|1.19||||||||1.19|0.91|
70936336|NCT04492475|141373246|SUPERIORITY||Cox Proportional Hazard|0.44|||||TWO_SIDED|95.0|0.24|0.82||||||||0.82|0.24|
71060228|NCT03281876|141628017|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|0.995||||0.9634|TWO_SIDED|95.0|0.792|1.249|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for moderate AECOPDs, one year follow-up starting 1 month post dose 2||1.249|0.792|0.9634
71060229|NCT03281876|141628017|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|0.722||||0.1755|TWO_SIDED|95.0|0.45|1.157|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for severe AECOPDs, one year follow-up starting 1 month post dose 2||1.157|0.45|0.1755
71060230|NCT03281876|141628024|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|1.038||||0.9463|TWO_SIDED|95.0|0.73|1.477|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for moderate or severe NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2||1.477|0.73|0.9463
71060231|NCT03281876|141628025|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|1.093||||0.6042|TWO_SIDED|95.0|0.782|1.528|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for any NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2||1.528|0.782|0.6042
71060232|NCT03281876|141628026|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|2.243||||0.0777|TWO_SIDED|95.0|0.914|5.504|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for mild NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2||5.504|0.914|0.0777
71060233|NCT03281876|141628026|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|1.021||||0.9121|TWO_SIDED|95.0|0.71|1.467|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for moderate NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2||1.467|0.71|0.9121
71060234|NCT03281876|141628026|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|1.12||||0.8737|TWO_SIDED|95.0|0.278|4.502|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for severe NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2||4.502|0.278|0.8737
71060235|NCT01074944|141628047|NON_INFERIORITY_OR_EQUIVALENCE|Eliglustat QD treatment was declared non-inferior to BID treatment if the lower bound of the 95% confidence interval (CI) for the difference was within the non-inferiority margin of -0.15 (or -15%).|Difference in Percentage Stable|-2.7|||||TWO_SIDED|95.0|-17.7|11.9||||||||11.9|-17.7|
70936337|NCT04492475|141373247|SUPERIORITY||Cox Proportional Hazard|1.08|||||TWO_SIDED|95.0|0.93|1.26||||||||1.26|0.93|
71060236|NCT01263938|141628083|OTHER|||||||0.625||||||Threshold for statistical significance: p\<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.||||0.625
71109651|NCT02722408|141724378|OTHER|||||||0.5268||||||Mixed-effects model for repeated measures analysis with percent change in hsCRP as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.5268
71109652|NCT02722408|141724379|OTHER|||||||0.1099||||||Mixed-effects model for repeated measures analysis with change in hsCRP as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.1099
71109653|NCT02722408|141724379|OTHER|||||||0.5478||||||Mixed-effects model for repeated measures analysis with change in hsCRP as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.5478
70936338|NCT04492475|141373247|SUPERIORITY||Cox Proportional Hazard|0.39|||||TWO_SIDED|95.0|0.21|0.72||||||||0.72|0.21|
70936339|NCT04492475|141373248|SUPERIORITY||Cox Proportional Hazard|1.04|||||TWO_SIDED|95.0|0.9|1.19||||||||1.19|0.90|
70936340|NCT04492475|141373249|SUPERIORITY||Cox Proportional Hazard|0.92|||||TWO_SIDED|95.0|0.59|1.45||||||This analysis is for Asian participants.||1.45|0.59|
70936341|NCT04492475|141373249|SUPERIORITY||Cox Proportional Hazard|0.92|||||TWO_SIDED|95.0|0.66|1.27||||||This analysis is for Black and African American participants.||1.27|0.66|
70936342|NCT04492475|141373249|SUPERIORITY||Cox Proportional Hazard|1.02|||||TWO_SIDED|95.0|0.86|1.21||||||This analysis is for White participants.||1.21|0.86|
70936343|NCT04492475|141373249|SUPERIORITY||Cox Proportional Hazard|0.84|||||TWO_SIDED|95.0|0.59|1.19||||||This analysis is for Race of Other participants||1.19|0.59|
70936344|NCT04492475|141373250|SUPERIORITY||Cox Proportional Hazard|1.02|||||TWO_SIDED|95.0|0.86|1.19||||||This analysis is for Not Hispanic or Latino participants.||1.19|0.86|
70936345|NCT04492475|141373250|SUPERIORITY||Cox Proportional Hazard|0.83|||||TWO_SIDED|95.0|0.65|1.05||||||This analysis is for Hispanic or Latino participants.||1.05|0.65|
70936346|NCT04492475|141373251|SUPERIORITY||Cox Proportional Hazard|0.93|||||TWO_SIDED|95.0|0.78|1.1||||||This analysis is for Male participants.||1.10|0.78|
70936347|NCT04492475|141373251|SUPERIORITY||Cox Proportional Hazard|1.05|||||TWO_SIDED|95.0|0.86|1.29||||||This analysis is for Female participants.||1.29|0.86|
71060237|NCT01263938|141628083|OTHER|||||||0.813||||||Threshold for statistical significance: p\<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.||||0.813
71060238|NCT01263938|141628083|OTHER||||||>|0.999||||||Threshold for statistical significance: p\<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.||||>0.999
71060239|NCT01263938|141628084|OTHER||||||>|0.999||||||Threshold for statistical significance: p\<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.||||>0.999
71060240|NCT01263938|141628085|OTHER|||||||0.813||||||Threshold for statistical significance: p\<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.||||0.813
71060241|NCT01263938|141628086|OTHER|||||||0.625||||||Threshold for statistical significance: p\<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.||||0.625
71060242|NCT00550459|141628092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23|STANDARD_DEVIATION|0.55||0.08|TWO_SIDED|95.0|-0.03|0.5||Secondary endpoints were ordered in 5 tiers to be analyzed only when \>=1 of the endpoints in the prior tier were significant. Since primary endpoint not stat significant, analyses of secondary endpoint tiers presented for exploratory purposes only|ANCOVA|ANCOVA with factors of treatment, disease severity, age(6 Degrees of Freedom), and covariate baseline to fit primary endpoint using the ITT dataset.||Analysis of covariance (ANCOVA) with factors of treatment,disease severity (\<130mEq/L \[mmol/L\] or ≥130mEq/L \[mmol/L\] at baseline),age (\<65, ≥65 to \<75,and ≥75 years) (factor with 6 Degrees of Freedom), and covariate baseline used to fit primary endpoint using the intent-to-treat (ITT) dataset. Estimated treatment effect and its 95% confidence interval (CI) provided under the model with p-value. A 2-sided alpha (0.05) applied to the primary analysis. Primary analysis based on observed cases (OC).||0.50|-0.03|0.08
71060243|NCT00550459|141628093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|0.63||0.21|TWO_SIDED|95.0|-0.12|0.51||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||0.51|-0.12|0.21
71060244|NCT00550459|141628094|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.27|STANDARD_DEVIATION|0.41||0.02|TWO_SIDED|95.0|0.04|0.51||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||0.51|0.04|0.02
71060245|NCT00550459|141628095|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.26|STANDARD_DEVIATION|0.83||0.21|TWO_SIDED|95.0|-0.15|0.67||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||0.67|-0.15|0.21
71060246|NCT00550459|141628096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12|STANDARD_DEVIATION|0.39||0.16|TWO_SIDED|95.0|-0.05|0.3||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||0.30|-0.05|0.16
71109654|NCT02722408|141724379|OTHER|||||||0.8837||||||Mixed-effects model for repeated measures analysis with change in hsCRP as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.8837
71109655|NCT02722408|141724380|OTHER|||||||0.0587||||||Mixed-effects model for repeated measures analysis with percent change in fibrinogen as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0587
71060247|NCT00550459|141628097|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.51|STANDARD_DEVIATION|3.53||0.23|TWO_SIDED|95.0|-4.02|1.0||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||1.00|-4.02|0.23
71060248|NCT00550459|141628098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.83|STANDARD_DEVIATION|3.51||0.18|TWO_SIDED|95.0|-2.04|0.38||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||0.38|-2.04|0.18
71060249|NCT00550459|141628099|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.75|STANDARD_DEVIATION|3.45|<|0.0001|TWO_SIDED|95.0|2.89|6.6||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||6.60|2.89|<0.0001
71060250|NCT00967330|141628140|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Chi-squared|||||||<0.0001
71060251|NCT00967330|141628141|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.588||||0.0012|TWO_SIDED|95.0|0.423|0.817|||Chi-squared|||||0.817|0.423|0.0012
71060252|NCT00967330|141628142|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.963||||0.8283|TWO_SIDED|95.0|0.684|1.354|||Chi-squared|||||1.354|0.684|0.8283
71060253|NCT00967330|141628144|SUPERIORITY_OR_OTHER||Difference in response rate|0.06||||0.34745|TWO_SIDED|95.0|-0.02|0.14|||Fisher Exact|||Response rate based on participants with CR at 4 weeks after RT.||0.14|-0.02|0.34745
70936348|NCT03989232|141373252|SUPERIORITY||Treatment difference|-0.23||||0.0003|TWO_SIDED|95.0|-0.36|-0.11|||ANCOVA|||On-treatment without rescue medication observation period: Imputation of missing data was handled by multiple imputation (MI) assuming that missing data were missed at random (MAR). The imputation was performed separately within each treatment group defined by randomised treatment.||-0.11|-0.36|0.0003
71060254|NCT00967330|141628144|SUPERIORITY_OR_OTHER||Difference in response rate|0.09||||0.17923|TWO_SIDED|95.0|0.0|0.17|||Fisher Exact|||The response rate based on participants with CR at \>4 weeks after RT.||0.17|0.00|0.17923
71060255|NCT00967330|141628144|SUPERIORITY_OR_OTHER||Difference in response rate|0.0||||1|TWO_SIDED|95.0|-0.08|0.08|||Fisher Exact|||The response rate based on participants with CR at Month 6.||0.08|-0.08|1.00000
71060256|NCT00967330|141628144|SUPERIORITY_OR_OTHER||Difference in response rate|0.25||||0.0021|TWO_SIDED|95.0|0.12|0.38|||Fisher Exact|||Response rate based on participants with CR or PR at 4 weeks after RT.||0.38|0.12|0.00210
71060257|NCT00967330|141628144|SUPERIORITY_OR_OTHER||Difference in response rate|0.1||||0.18761|TWO_SIDED|95.0|-0.02|0.23|||Fisher Exact|||Response rate based on participants with CR and PR at \>4 weeks after RT.||0.23|-0.02|0.18761
71060258|NCT00967330|141628144|SUPERIORITY_OR_OTHER||Difference in response rate|-0.05||||0.38974|TWO_SIDED|95.0|-0.18|0.07|||Fisher Exact|||Response rate based on participants with CR or PR at Month 6.||0.07|-0.18|0.38974
71060259|NCT00967330|141628146|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|2.1002||||0.4975|TWO_SIDED|95.0|-3.9855|8.186|||ANOVA|||Physical Functioning. Analysis of variance (ANOVA) included all post-baseline data (Months 3 through 21).||8.1860|-3.9855|0.4975
71060260|NCT00967330|141628146|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4704||||0.76|TWO_SIDED|95.0|-10.9358|7.9951|||ANOVA|||Role Functioning. ANOVA included all post-baseline data (Months 3 through 21).||7.9951|-10.9358|0.7600
71060261|NCT00967330|141628146|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02278||||0.9949|TWO_SIDED|95.0|-7.035|6.9895|||ANOVA|||Emotional Functioning. ANOVA included all post-baseline data (Months 3 through 21).||6.9895|-7.0350|0.9949
71060262|NCT00967330|141628146|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8213||||0.6253|TWO_SIDED|95.0|-9.155|5.5125|||ANOVA|||Cognitive Functioning. ANOVA included all post-baseline data (Months 3 through 21).||5.5125|-9.1550|0.6253
71060263|NCT00967330|141628146|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6126||||0.7219|TWO_SIDED|95.0|-7.2953|10.5205|||ANOVA|||Social Functioning. ANOVA included all post-baseline data (Months 3 through 21).||10.5205|-7.2953|0.7219
71060264|NCT00967330|141628146|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4989||||0.2443|TWO_SIDED|95.0|-2.4046|9.4023|||ANOVA|||Global Health Status /QoL. ANOVA included all post-baseline data (Months 3 through 21).||9.4023|-2.4046|0.2443
71060265|NCT00967330|141628146|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.3449||||0.3287|TWO_SIDED|95.0|-10.0739|3.3841|||ANOVA|||Fatigue. ANOVA included all post-baseline data (Months 3 through 21).||3.3841|-10.0739|0.3287
71109656|NCT02722408|141724380|OTHER|||||||0.1491||||||Mixed-effects model for repeated measures analysis with percent change in fibrinogen as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.1491
71109657|NCT02722408|141724380|OTHER|||||||0.2224||||||Mixed-effects model for repeated measures analysis with percent change in fibrinogen as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.2224
71060266|NCT00967330|141628146|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.196||||0.0485|TWO_SIDED|95.0|-8.3635|-0.0285|||ANOVA|||Nausea/Vomiting. ANOVA included all post-baseline data (Months 3 through 21).||-0.02850|-8.3635|0.0485
71109658|NCT02722408|141724381|OTHER|||||||0.0959||||||Mixed-effects model for repeated measures analysis with change in fibrinogen as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0959
71109659|NCT02722408|141724381|OTHER|||||||0.0923||||||Mixed-effects model for repeated measures analysis with change in fibrinogen as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0923
71060267|NCT00967330|141628146|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.095||||0.0354|TWO_SIDED|95.0|-17.5629|-0.6271|||ANOVA|||Pain. ANOVA included all post-baseline data (Months 3 through 21).||-0.6271|-17.5629|0.0354
71060268|NCT00967330|141628146|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.2088||||0.3724|TWO_SIDED|95.0|-10.2784|3.8608|||ANOVA|||Dyspnoea. ANOVA included all post-baseline data (Months 3 through 21).||3.8608|-10.2784|0.3724
71060269|NCT00967330|141628146|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.876||||0.2884|TWO_SIDED|95.0|-13.9002|4.1482|||ANOVA|||Insomnia. ANOVA included all post-baseline data (Months 3 through 21).||4.1482|-13.9002|0.2884
71060270|NCT00967330|141628146|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.782||||0.4081|TWO_SIDED|95.0|-9.3926|3.8282|||ANOVA|||Appetite loss. ANOVA included all post-baseline data (Months 3 through 21).||3.8282|-9.3926|0.4081
71060271|NCT00967330|141628146|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.9375||||0.275|TWO_SIDED|95.0|-11.0245|3.1495|||ANOVA|||Constipation. ANOVA included all post-baseline data (Months 3 through 21).||3.1495|-11.0245|0.2750
71060272|NCT00967330|141628146|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.1685||||0.0213|TWO_SIDED|95.0|-11.4129|-0.9241|||ANOVA|||Diarrhoea. ANOVA included all post-baseline data (Months 3 through 21).||-0.9241|-11.4129|0.0213
71060273|NCT00967330|141628146|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7295||||0.5201|TWO_SIDED|95.0|-11.0727|5.6137|||ANOVA|||Financial Problems. ANOVA included all post-baseline data (Months 3 through 21).||5.6137|-11.0727|0.5201
71060274|NCT00967330|141628147|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.2699||||0.3613|TWO_SIDED|95.0|-10.2983|3.7585|||ANOVA|||Future uncertainty. ANOVA included all post-baseline data (Months 3 through 21).||3.7585|-10.2983|0.3613
71060275|NCT00967330|141628147|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1159||||0.6146|TWO_SIDED|95.0|-5.4654|3.2336|||ANOVA|||Visual disorder. ANOVA included all post-baseline data (Months 3 through 21).||3.2336|-5.4654|0.6146
71060276|NCT00967330|141628147|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1014||||0.686|TWO_SIDED|95.0|-4.2449|6.4477|||ANOVA|||Motor dysfunction. ANOVA included all post-baseline data (Months 3 through 21).||6.4477|-4.2449|0.6860
71060277|NCT00967330|141628147|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1009||||0.9706|TWO_SIDED|95.0|-5.468|5.2663|||ANOVA|||Communication deficit. ANOVA included all post-baseline data (Months 3 through 21).||5.2663|-5.4680|0.9706
71060278|NCT00967330|141628147|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.3294||||0.0124|TWO_SIDED|95.0|-14.855|-1.8037|||ANOVA|||Headaches. ANOVA included all post-baseline data (Months 3 through 21).||-1.8037|-14.8550|0.0124
71060279|NCT00967330|141628147|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0054||||0.5997|TWO_SIDED|95.0|-4.7654|2.7545|||ANOVA|||Seizures. ANOVA included all post-baseline data (Months 3 through 21).||2.7545|-4.7654|0.5997
71060280|NCT00967330|141628147|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4399||||0.3458|TWO_SIDED|95.0|-10.6002|3.7204|||ANOVA|||Drowsiness. ANOVA included all post-baseline data (Months 3 through 21).||3.7204|-10.6002|0.3458
71060281|NCT00967330|141628147|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.5908||||0.2383|TWO_SIDED|95.0|-12.2279|3.0464|||ANOVA|||Hair loss. ANOVA included all post-baseline data (Months 3 through 21).||3.0464|-12.2279|0.2383
71109660|NCT02722408|141724381|OTHER|||||||0.1592||||||Mixed-effects model for repeated measures analysis with change in fibrinogen as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.1592
71060282|NCT00967330|141628147|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9807||||0.7491|TWO_SIDED|95.0|-5.0373|6.9988|||ANOVA|||Itchy skin. ANOVA included all post-baseline data (Months 3 through 21).||6.9988|-5.0373|0.7491
71060283|NCT00967330|141628147|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0341||||0.7755|TWO_SIDED|95.0|-8.1508|6.0827|||ANOVA|||Weakness of legs. ANOVA included all post-baseline data (Months 3 through 21).||6.0827|-8.1508|0.7755
71060284|NCT00967330|141628147|SUPERIORITY_OR_OTHER||LS Mean Difference|0.469||||0.841|TWO_SIDED|95.0|-4.1211|5.0591|||ANOVA|||Bladder control. ANOVA included all post-baseline data (Months 3 through 21).||5.0591|-4.1211|0.8410
71060285|NCT00967330|141628148|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1933||||0.0817|TWO_SIDED|95.0|-0.411|0.02438|||ANOVA|||Orientation to time and place. ANOVA included all post-baseline data (Months 3 through 21).||0.02438|-0.4110|0.0817
71060286|NCT00967330|141628148|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02955||||0.0773|TWO_SIDED|95.0|-0.06234|0.003241|||ANOVA|||Immediate recall. ANOVA included all post-baseline data (Months 3 through 21).||0.003241|-0.06234|0.0773
71060287|NCT00967330|141628148|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1429||||0.2608|TWO_SIDED|95.0|-0.1065|0.3924|||ANOVA|||Repetitions required. ANOVA included all post-baseline data (Months 3 through 21).||0.3924|-0.1065|0.2608
71060288|NCT00967330|141628148|SUPERIORITY_OR_OTHER||LS Mean Difference|0.003262||||0.9836|TWO_SIDED|95.0|-0.3092|0.3158|||ANOVA|||Calculations. ANOVA included all post-baseline data (Months 3 through 21).||0.3158|-0.3092|0.9836
71060289|NCT00967330|141628148|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03782||||0.661|TWO_SIDED|95.0|-0.2071|0.1315|||ANOVA|||Short-term verbal memory. ANOVA included all post-baseline data (Months 3 through 21).||0.1315|-0.2071|0.6610
71060290|NCT00967330|141628148|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08037||||0.4464|TWO_SIDED|95.0|-0.2875|0.1268|||ANOVA|||Language and construct ability. ANOVA included all post-baseline data (Months 3 through 21).||0.1268|-0.2875|0.4464
71060291|NCT00967330|141628148|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3128||||0.4717|TWO_SIDED|95.0|-1.1658|0.5402|||ANOVA|||Total score. ANOVA included all post-baseline data (Months 3 through 21).||0.5402|-1.1658|0.4717
71060292|NCT00967330|141628149|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.151||||0.2078|TWO_SIDED|95.0|-5.4983|1.1963|||ANOVA|||KPS score. ANOVA included all post-baseline data (Months 3 through 21).||1.1963|-5.4983|0.2078
71060293|NCT01243957|141628152|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.79|||||TWO_SIDED|90.0|1.61|2.0|||ANOVA|||||2.00|1.61|
71060294|NCT01243957|141628153|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.63|||||TWO_SIDED|90.0|1.49|1.79|||ANOVA|||||1.79|1.49|
71109661|NCT02722408|141724382|OTHER|||||||0.5856||||||Mixed-effects model for repeated measures analysis with percent change in Lipoprotein(a) as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.5856
71109662|NCT02722408|141724382|OTHER|||||||0.644||||||Mixed-effects model for repeated measures analysis with percent change in Lipoprotein(a) as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.6440
70936349|NCT03989232|141373252|SUPERIORITY||Treatment difference|-0.18||||0.0098|TWO_SIDED|95.0|-0.31|-0.04|||ANCOVA|||In-trial observation period: Imputation of missing data was handled by MI assuming that missing data were missed at random. The imputation was performed by imputing missing week 40 data separately within groups defined by randomised treatment and treatment status at week 40.||-0.04|-0.31|0.0098
70936350|NCT03212638|141373276|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|Ratio|1.04|||||TWO_SIDED|95.0|0.946|1.15||||||Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation with (T1) water compared to the commercial tablet (R).||1.15|0.946|
70936351|NCT03212638|141373276|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|ratio|1.04|||||TWO_SIDED|95.0|0.944|1.14||||||Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation without (T2) water compared to the commercial tablet (R).||1.14|0.944|
70936352|NCT03212638|141373276|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|Ratio|0.675|||||TWO_SIDED|95.0|0.617|0.74||||||Bioequivalence of single 4 mg dose of baricitinib as fasted vs fed.||0.740|0.617|
70936353|NCT03212638|141373277|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|Ratio|0.996|||||TWO_SIDED|95.0|0.963|1.03||||||Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation with (T1) water compared to the commercial tablet (R).||1.03|0.963|
70936354|NCT03212638|141373277|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|Ratio|0.998|||||TWO_SIDED|95.0|0.995|1.03||||||Bioequivalence of s single 4 mg dose of baricitinib as the suspension formulation without (T2) water compared to the commercial tablet (R).||1.03|0.995|
70936355|NCT03212638|141373277|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|ratio|0.973|||||TWO_SIDED|95.0|0.936|1.01||||||Bioequivalence of single 4 mg dose of baricitinib as fasted vs fed.||1.01|0.936|
70936356|NCT03212638|141373278|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|Ratio|0.999|||||TWO_SIDED|95.0|0.996|1.03||||||Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation with (T1) water compared to the commercial tablet (R).||1.03|0.996|
70936357|NCT03212638|141373278|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|Ratio|0.999|||||TWO_SIDED|95.0|0.966|1.03||||||Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation with (T1) water compared to the commercial tablet (R).||1.03|0.966|
70936358|NCT03212638|141373278|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|ratio|0.978|||||TWO_SIDED|95.0|0.941|1.02||||||Bioequivalence of single 4 mg dose of baricitinib as fasted vs fed.||1.02|0.941|
71060295|NCT01243957|141628154|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.5459|TWO_SIDED|90.0|-0.5|0.5|||Wilcoxon (Mann-Whitney)|||||0.50|-0.50|0.5459
71060296|NCT01243957|141628155|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.01|||||TWO_SIDED|90.0|0.99|1.04|||ANOVA|||Ratio of Geometric LS Means of AUCτ for fluoxetine alone and fluoxetine + LY2216684.||1.04|0.99|
71060297|NCT01243957|141628155|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|1.01|1.06|||ANOVA|||Ratio of Geometric LS Means of AUCτ for norfluoxetine alone and norfluoxetine + LY2216684.||1.06|1.01|
71060298|NCT01243957|141628156|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.0|||||TWO_SIDED|90.0|0.97|1.03|||ANOVA|||Ratio of Geometric LS Means of Cmax for fluoxetine alone and fluoxetine + LY2216684||1.03|0.97|
71060299|NCT01243957|141628156|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.03|||||TWO_SIDED|90.0|1.0|1.07|||ANOVA|||Ratio of Geometric LS Means of Cmax for norfluoxetine alone and norfluoxetine + LY2216684.||1.07|1.00|
70936359|NCT01323790|141373279|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.188||||0.202|TWO_SIDED|95.0|0.911|1.548|||Cochran-Mantel-Haenszel|||Analysis via Cochran Mantel-Haenszel test stratified by response to laxatives at baseline (LIR, LAR, LUR).||1.548|0.911|0.202
70936360|NCT01323790|141373279|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.348||||0.021|TWO_SIDED|95.0|1.045|1.739|||Cochran-Mantel-Haenszel|||Analysis via Cochran Mantel-Haenszel test stratified by response to laxatives at baseline (LIR, LAR, LUR).||1.739|1.045|0.021
70936361|NCT01323790|141373280|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.35||||0.074|TWO_SIDED|95.0|0.967|1.884||Response rate over Weeks 1 to 12 in the LIR subgroup is a key secondary endpoint included in the multiple testing procedure.|Cochran-Mantel-Haenszel|||||1.884|0.967|0.074
70936362|NCT01323790|141373280|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.489||||0.014|TWO_SIDED|95.0|1.078|2.058||Response rate over Weeks 1 to 12 in the LIR subgroup is a key secondary endpoint included in the multiple testing procedure.|Cochran-Mantel-Haenszel|||||2.058|1.078|0.014
70936363|NCT01323790|141373282|SUPERIORITY_OR_OTHER||LS mean difference|0.39||||0.01|TWO_SIDED|95.0|0.09|0.69|||Mixed Models Analysis|||Analysis via Mixed Model Repeated Measures (MMRM) with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.69|0.09|0.010
70936364|NCT01323790|141373282|SUPERIORITY_OR_OTHER||Ls mean difference|0.68|||<|0.001|TWO_SIDED|95.0|0.37|0.98|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.98|0.37|<0.001
71060300|NCT01243957|141628157|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.08||||0.423|TWO_SIDED|90.0|-3.0|1.42|||Wilcoxon (Mann-Whitney)|||Ratio of Geometric LS Means of Tmax for fluoxetine alone and fluoxetine + LY2216684.||1.42|-3.00|0.4230
70936365|NCT01323790|141373283|SUPERIORITY_OR_OTHER||LS mean difference|-0.19||||0.005|TWO_SIDED|95.0|-0.32|-0.06|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.06|-0.32|0.005
70936366|NCT01323790|141373283|SUPERIORITY_OR_OTHER||LS mean difference|-0.32|||<|0.001|TWO_SIDED|95.0|-0.45|-0.18|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.18|-0.45|<0.001
70936367|NCT01323790|141373284|SUPERIORITY_OR_OTHER||LS mean difference|0.28||||0.001|TWO_SIDED|95.0|0.12|0.45|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.45|0.12|0.001
71109663|NCT02722408|141724382|OTHER|||||||0.2269||||||Mixed-effects model for repeated measures analysis with percent change in Lipoprotein(a) as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.2269
71060301|NCT01243957|141628157|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.0||||0.0293|TWO_SIDED|90.0|-6.5|-1.0|||Wilcoxon (Mann-Whitney)|||Ratio of Geometric LS Means of Tmax for norfluoxetine alone and norfluoxetine + LY2216684.||-1.00|-6.50|0.0293
71109664|NCT02722408|141724383|OTHER|||||||0.4814||||||Mixed-effects model for repeated measures analysis with change in Lipoprotein(a) as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.4814
71109665|NCT02722408|141724383|OTHER|||||||0.5011||||||Mixed-effects model for repeated measures analysis with change in Lipoprotein(a) as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.5011
71109666|NCT02722408|141724383|OTHER|||||||0.4356||||||Mixed-effects model for repeated measures analysis with change in Lipoprotein(a) as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.4356
71109667|NCT02722408|141724384|OTHER|||||||0.0669||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein B as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0669
71109668|NCT02722408|141724384|OTHER|||||||0.0189||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein B as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0189
71109669|NCT02722408|141724384|OTHER|||||||0.0316||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein B as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0316
71109670|NCT02722408|141724385|OTHER|||||||0.0685||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein B as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0685
71109671|NCT02722408|141724385|OTHER|||||||0.0114||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein B as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0114
71109672|NCT02722408|141724385|OTHER|||||||0.0263||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein B as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0263
71109673|NCT02722408|141724386|OTHER|||||||0.1466||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein A-I as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.1466
71109674|NCT02722408|141724386|OTHER|||||||0.3598||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein A-I as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.3598
71060302|NCT02623725|141628158|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95 percent (%) Confidence Interval (CI) of the Geometric mean of titer ratios (GMTRs) (booster vs post-dose 3) was greater than (\>) 1/2 for each serotype.|Geometric mean of titer ratio|1.66|||||TWO_SIDED|95.0|1.33|2.06||||||Dengue Virus Serotype 1||2.06|1.33|
71060303|NCT02623725|141628158|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was \>1/2 for each serotype.|Geometric mean of titer ratio|1.82|||||TWO_SIDED|95.0|1.43|2.31||||||Dengue Virus Serotype 2||2.31|1.43|
71109675|NCT02722408|141724386|OTHER|||||||0.0685||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein A-I as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0685
71109676|NCT02722408|141724387|OTHER|||||||0.166||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein A-I as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.1660
71109677|NCT02722408|141724387|OTHER|||||||0.3423||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein A-I as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.3423
71109678|NCT02722408|141724387|OTHER|||||||0.0313||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein A-I as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0313
70936368|NCT01323790|141373284|SUPERIORITY_OR_OTHER||LS mean difference|0.45|||<|0.001|TWO_SIDED|95.0|0.29|0.62|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.62|0.29|<0.001
70936369|NCT01323790|141373285|SUPERIORITY_OR_OTHER||LS mean difference|6.72||||0.002|TWO_SIDED|95.0|2.37|11.06|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||11.06|2.37|0.002
70936370|NCT01323790|141373285|SUPERIORITY_OR_OTHER||LS mean difference|10.43|||<|0.001|TWO_SIDED|95.0|6.03|14.84|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||14.84|6.03|<0.001
70936371|NCT01323790|141373286|SUPERIORITY_OR_OTHER||LS mean difference|0.52||||0.028|TWO_SIDED|95.0|0.06|0.98|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.98|0.06|0.028
70936372|NCT01323790|141373286|SUPERIORITY_OR_OTHER||LS mean difference|1.04|||<|0.001|TWO_SIDED|95.0|0.58|1.51|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||1.51|0.58|<0.001
70936373|NCT01323790|141373288|SUPERIORITY_OR_OTHER||LS mean difference|-0.12||||0.08|TWO_SIDED|95.0|-0.26|0.01||Analysis for change in PAC-SYM total score from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.01|-0.26|0.080
70936374|NCT01323790|141373288|SUPERIORITY_OR_OTHER||LS mean difference|-0.18||||0.011|TWO_SIDED|95.0|-0.32|-0.04||Analysis for change in PAC-SYM total score from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.04|-0.32|0.011
70936375|NCT01323790|141373288|SUPERIORITY_OR_OTHER||Slope|0.05||||0.552|TWO_SIDED|95.0|-0.11|0.2||Analysis for change in PAC-SYM abdominal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.20|-0.11|0.552
70936376|NCT01323790|141373288|SUPERIORITY_OR_OTHER||LS mean difference|0.09||||0.236|TWO_SIDED|95.0|-0.06|0.25||Analysis for change in PAC-SYM abdominal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.25|-0.06|0.236
71060304|NCT02623725|141628158|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was \>1/2 for each serotype.|Geometric mean of titer ratio|1.04|||||TWO_SIDED|95.0|0.841|1.27||||||Dengue Virus Serotype 3||1.27|0.841|
70936377|NCT01323790|141373288|SUPERIORITY_OR_OTHER||LS mean difference|-0.11||||0.095|TWO_SIDED|95.0|-0.24|0.02||Analysis for change in PAC-SYM rectal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.02|-0.24|0.095
71109679|NCT02722408|141724388|OTHER|||||||0.7196||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein A-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.7196
71109680|NCT02722408|141724388|OTHER|||||||0.4343||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein A-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.4343
71109681|NCT02722408|141724388|OTHER|||||||0.7241||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein A-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.7241
71060305|NCT02623725|141628158|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was \>1/2 for each serotype.|Geometric mean of titer ratio|1.32|||||TWO_SIDED|95.0|1.01|1.74||||||Dengue Virus Serotype 4||1.74|1.01|
71060306|NCT02623725|141628159|SUPERIORITY|The superiority was to be demonstrated if the lower limit of the two-sided 95% CI for the ratio was \>1.|Geometric mean of titer ratio|1.66|||||TWO_SIDED|95.0|1.34|2.05||||||Dengue Virus Serotype 1||2.05|1.34|
71109682|NCT02722408|141724389|OTHER|||||||0.7952||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein A-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.7952
70936378|NCT01323790|141373288|SUPERIORITY_OR_OTHER||LS mean difference|-0.24|||<|0.001|TWO_SIDED|95.0|-0.37|-0.1||Analysis for change in PAC-SYM rectal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.10|-0.37|<0.001
70936379|NCT01323790|141373288|SUPERIORITY_OR_OTHER||LS mean difference|-0.27||||0.002|TWO_SIDED|95.0|-0.44|-0.1||Analysis for change in PAC-SYM stool symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.10|-0.44|0.002
70936380|NCT01323790|141373288|SUPERIORITY_OR_OTHER||LS mean difference|-0.38|||<|0.001|TWO_SIDED|95.0|-0.56|-0.21||Analysis for change in PAC-SYM stool symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.21|-0.56|<0.001
70936381|NCT01323790|141373289|SUPERIORITY_OR_OTHER||LS mean difference|-0.31||||0.011|TWO_SIDED|95.0|-0.54|-0.07|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.07|-0.54|0.011
70936382|NCT01323790|141373289|SUPERIORITY_OR_OTHER||LS mean difference|-0.49|||<|0.001|TWO_SIDED|95.0|-0.73|-0.25|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.25|-0.73|<0.001
70936383|NCT01263496|141373291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.401|||||TWO_SIDED|95.0|-0.618|-0.184||||||||-0.184|-0.618|
70936384|NCT01263496|141373291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.548|||||TWO_SIDED|95.0|-0.739|-0.358||||||||-0.358|-0.739|
71060307|NCT02623725|141628159|SUPERIORITY|The superiority was to be demonstrated if the lower limit of the two-sided 95% CI for the ratio was \>1.|Geometric mean of titer ratio|1.89|||||TWO_SIDED|95.0|1.49|2.41||||||Dengue Virus Serotype 2||2.41|1.49|
70936385|NCT01263496|141373291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||||TWO_SIDED|95.0|-0.779|-0.401||||||||-0.401|-0.779|
70936386|NCT01263496|141373291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.708|||||TWO_SIDED|95.0|-0.894|-0.522||||||||-0.522|-0.894|
70936387|NCT01263496|141373292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.316|||||TWO_SIDED|95.0|-0.538|-0.093||||||||-0.093|-0.538|
70936388|NCT01263496|141373292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.493|||||TWO_SIDED|95.0|-0.684|-0.302||||||||-0.302|-0.684|
70936389|NCT01263496|141373292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|||||TWO_SIDED|95.0|-0.706|-0.314||||||||-0.314|-0.706|
70936390|NCT01263496|141373292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.647|||||TWO_SIDED|95.0|-0.834|-0.461||||||||-0.461|-0.834|
70936391|NCT01263496|141373293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.263|||||TWO_SIDED|95.0|-0.479|-0.047||||||||-0.047|-0.479|
71060308|NCT02623725|141628159|SUPERIORITY|The superiority was to be demonstrated if the lower limit of the two-sided 95% CI for the ratio was \>1.|Geometric mean of titer ratio|1.06|||||TWO_SIDED|95.0|0.86|1.3||||||Dengue Virus Serotype 3||1.30|0.860|
71060309|NCT02623725|141628159|SUPERIORITY|The superiority was to be demonstrated if the lower limit of the two-sided 95% CI for the ratio was \>1.|Geometric mean of titer ratio|1.33|||||TWO_SIDED|95.0|1.02|1.73||||||Dengue Virus Serotype 4||1.73|1.02|
71060310|NCT03759392|141628172|SUPERIORITY||Least squares mean difference|-0.447|STANDARD_ERROR_OF_MEAN|0.2931||0.13|TWO_SIDED|95.0|-1.024|0.131|||ANCOVA|Using multiple imputation||||0.131|-1.024|0.13
71060311|NCT03759392|141628173|SUPERIORITY||Least squares mean difference|-5.388|STANDARD_ERROR_OF_MEAN|2.3937||0.025|TWO_SIDED|95.0|-10.108|-0.0668|||ANCOVA|Using multiple imputation||||-0.0668|-10.108|0.025
71060312|NCT03759392|141628174|SUPERIORITY||Least squares mean difference|0.414|STANDARD_ERROR_OF_MEAN|0.6215||0.51|TWO_SIDED|95.0|-0.81|1.639|||ANCOVA|Using multiple imputation||||1.639|-0.810|0.51
71060313|NCT03759392|141628175|SUPERIORITY||Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.42||0.54|TWO_SIDED|95.0|-0.6|1.1|||Repeated measures mixed model|||||1.1|-0.6|0.54
71060314|NCT05620082|141628182|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
71060315|NCT05620082|141628183|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71060316|NCT05620082|141628184|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71060317|NCT05620082|141628185|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Comparing Appearance of supplements||||0.10
71060318|NCT05620082|141628185|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Comparing Smell of supplements between groups||||0.10
71060319|NCT05620082|141628185|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Comparing Taste of supplements||||0.08
71060320|NCT05620082|141628185|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Comparing Sweetness of supplements||||0.70
71060321|NCT05620082|141628185|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Comparing Texture of supplements||||0.02
71060322|NCT05620082|141628185|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Comparing Thickness of supplements||||0.45
71060323|NCT05620082|141628185|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Comparing Aftertaste of supplements||||0.25
71060324|NCT05620082|141628185|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Comparing 'Feeling in mouth' of supplements||||0.45
71060325|NCT05620082|141628185|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Comparing 'Future choice' of supplements||||0.06
71060326|NCT05620082|141628186|SUPERIORITY|||||||0.004||||||Pairwise comparisons with Bonferroni correction revealed a significant increase in total daily energy intake from baseline to porridge timepoints (p\<0.001).|Related samples Friedman's Two-Way ANOVA|||||||0.004
71060327|NCT02360215|141628188|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.029|TWO_SIDED|95.0|0.59|0.96|||Gray's test|||Null hypothesis: the addition of HA-WBRT as compared to WBRT will increase time to neurocognitive failure from 53.8% in the WBRT arm to 42.8% in the HA-WBRT arm at 6 months. Treating death as a competing risk and using a Gray's test with two-sided α=0.05 to test for statistically significant difference in the distribution of neurocognitive failure times, it was calculated that 230 events over both arms would provide 90% statistical power.||0.96|0.59|0.029
71060328|NCT02360215|141628189|SUPERIORITY|||||||0.0586|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Symptom Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.0586
71060329|NCT02360215|141628189|SUPERIORITY|||||||0.0048|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Symptom Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\>61 year vs. \<= 61 years) is reported here.||||0.0048
70936392|NCT01263496|141373293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.395|||||TWO_SIDED|95.0|-0.598|-0.192||||||||-0.192|-0.598|
70936393|NCT01263496|141373293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.405|||||TWO_SIDED|95.0|-0.616|-0.195||||||||-0.195|-0.616|
70936394|NCT01263496|141373293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.583|||||TWO_SIDED|95.0|-0.78|-0.386||||||||-0.386|-0.780|
71060330|NCT02360215|141628189|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Symptom Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline Total Recall is reported here.||||<0.0001
70936395|NCT01263496|141373294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.172|||||TWO_SIDED|95.0|-0.41|0.065||||||||0.065|-0.410|
70936396|NCT01263496|141373294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.319|||||TWO_SIDED|95.0|-0.55|-0.088||||||||-0.088|-0.550|
70936397|NCT01263496|141373294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|||||TWO_SIDED|95.0|-0.601|-0.139||||||||-0.139|-0.601|
70936398|NCT01263496|141373294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.533|||||TWO_SIDED|95.0|-0.752|-0.314||||||||-0.314|-0.752|
70936399|NCT01263496|141373295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.079|||||TWO_SIDED|95.0|-0.323|0.166||||||||0.166|-0.323|
70936400|NCT01263496|141373295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.241|||||TWO_SIDED|95.0|-0.471|-0.011||||||||-0.011|-0.471|
71060331|NCT02360215|141628190|SUPERIORITY|||||||0.2656|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recall Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.2656
71060332|NCT02360215|141628190|SUPERIORITY|||||||0.0067|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recall Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here.||||0.0067
71060333|NCT02360215|141628190|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recall Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline Delayed Recall is reported here.||||<0.0001
71060334|NCT02360215|141628191|SUPERIORITY|||||||0.0993|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recognition Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.0993
71109683|NCT02722408|141724389|OTHER|||||||0.4931||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein A-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.4931
71109684|NCT02722408|141724389|OTHER|||||||0.8622||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein A-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.8622
71109685|NCT02722408|141724390|OTHER|||||||0.9823||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein C-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.9823
71109686|NCT02722408|141724390|OTHER|||||||0.9129||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein C-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.9129
70936401|NCT01263496|141373295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.357|||||TWO_SIDED|95.0|-0.59|-0.124||||||||-0.124|-0.590|
70936402|NCT01263496|141373295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.467|||||TWO_SIDED|95.0|-0.692|-0.242||||||||-0.242|-0.692|
70936403|NCT01263496|141373296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|||||TWO_SIDED|95.0|-0.321|0.162||||||||0.162|-0.321|
70936404|NCT01263496|141373296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.294|||||TWO_SIDED|95.0|-0.542|-0.046||||||||-0.046|-0.542|
70936405|NCT01263496|141373296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.341|||||TWO_SIDED|95.0|-0.579|-0.103||||||||-0.103|-0.579|
70936406|NCT01263496|141373296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.487|||||TWO_SIDED|95.0|-0.722|-0.252||||||||-0.252|-0.722|
70936407|NCT01263496|141373297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.049|||||TWO_SIDED|95.0|-0.279|0.182||||||||0.182|-0.279|
71109687|NCT02722408|141724390|OTHER|||||||0.7762||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein C-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 84||||0.7762
71109688|NCT02722408|141724391|OTHER|||||||0.2683||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein C-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.2683
70936408|NCT01263496|141373297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.234|||||TWO_SIDED|95.0|-0.491|0.023||||||||0.023|-0.491|
71060335|NCT02360215|141628191|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recognition Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here.||||<0.0001
71060336|NCT02360215|141628191|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recognition Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline Delayed Recognition is reported here.||||<0.0001
71060337|NCT02360215|141628192|SUPERIORITY|||||||0.5988|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part A (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.5988
71060338|NCT02360215|141628192|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part A (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here.||||0.0005
71060339|NCT02360215|141628192|SUPERIORITY||||||<|0.0001|||||||McNemar|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part A (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline TMT Part A is reported here.||||<0.0001
71060340|NCT02360215|141628193|SUPERIORITY|||||||0.9226|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part B (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.9226
71060341|NCT02360215|141628193|SUPERIORITY||||||<|0.0024|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part B (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here.||||<0.0024
70936409|NCT01263496|141373297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.375|||||TWO_SIDED|95.0|-0.605|-0.145||||||||-0.145|-0.605|
71109689|NCT02722408|141724391|OTHER|||||||0.088||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein C-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0880
71109690|NCT02722408|141724391|OTHER|||||||0.0165||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein C-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0165
71109691|NCT02722408|141724392|OTHER|||||||0.4585||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein C-III as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.4585
71109692|NCT02722408|141724392|OTHER|||||||0.3721||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein C-III as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.3721
71109693|NCT02722408|141724392|OTHER|||||||0.5305||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein C-III as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.5305
71109694|NCT02722408|141724393|OTHER|||||||0.2937||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein C-III as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.2937
70936410|NCT01263496|141373297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.488|||||TWO_SIDED|95.0|-0.724|-0.252||||||||-0.252|-0.724|
71109695|NCT02722408|141724393|OTHER|||||||0.2182||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein C-III as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.2182
71109696|NCT02722408|141724393|OTHER|||||||0.2937||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein C-III as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.2937
71109697|NCT02722408|141724394|OTHER|||||||0.0411||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein E as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0411
71109698|NCT02722408|141724394|OTHER|||||||0.0192||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein E as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0192
71109699|NCT02722408|141724394|OTHER|||||||0.0445||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein E as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0445
70936411|NCT01263496|141373298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|||||TWO_SIDED|95.0|-0.27|0.169||||||||0.169|-0.270|
70936412|NCT01263496|141373298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.193|||||TWO_SIDED|95.0|-0.453|0.067||||||||0.067|-0.453|
70936413|NCT01263496|141373298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.374|||||TWO_SIDED|95.0|-0.596|-0.152||||||||-0.152|-0.596|
70936414|NCT01263496|141373298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|||||TWO_SIDED|95.0|-0.723|-0.256||||||||-0.256|-0.723|
71109700|NCT02722408|141724395|OTHER|||||||0.0465||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein E as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0465
71109701|NCT02722408|141724395|OTHER|||||||0.0221||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein E as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0221
71109702|NCT02722408|141724395|OTHER|||||||0.0402||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein E as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0402
71109703|NCT04776161|141724424|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.78|TWO_SIDED|95.0|-0.16|0.12|||Generalized linear models|Adjusted for age, sex, race||||0.12|-0.16|0.78
71109704|NCT04776161|141724424|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.79|TWO_SIDED|95.0|-0.1|0.13|||Generalized linear models|Adjusted for age, sex, race||||0.13|-0.10|0.79
71109705|NCT04776161|141724425|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.22|TWO_SIDED|95.0|-0.28|1.22|||Generalized linear models|Adjusted for age, sex, race and baseline uric acid level.||||1.22|-0.28|0.22
71109706|NCT04776161|141724425|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.24|TWO_SIDED|95.0|-0.33|1.26|||Generalized linear models|Adjusted for age, sex, race and baseline uric acid level||||1.26|-0.33|0.24
70936415|NCT01263496|141373299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|||||TWO_SIDED|95.0|-0.16|0.289||||||||0.289|-0.160|
70936416|NCT01263496|141373299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.236|||||TWO_SIDED|95.0|-0.477|0.005||||||||0.005|-0.477|
70936417|NCT01263496|141373299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-0.608|-0.113||||||||-0.113|-0.608|
70936418|NCT01263496|141373299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.435|||||TWO_SIDED|95.0|-0.679|-0.191||||||||-0.191|-0.679|
70936419|NCT01263496|141373300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.033|||||TWO_SIDED|95.0|-0.262|0.196||||||||0.196|-0.262|
70936420|NCT01263496|141373300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.262|||||TWO_SIDED|95.0|-0.516|-0.008||||||||-0.008|-0.516|
70936421|NCT01263496|141373300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.358|||||TWO_SIDED|95.0|-0.614|-0.103||||||||-0.103|-0.614|
70936422|NCT01263496|141373300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.432|||||TWO_SIDED|95.0|-0.69|-0.174||||||||-0.174|-0.690|
70936423|NCT01263496|141373301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.118|||||TWO_SIDED|95.0|-0.346|0.11||||||||0.110|-0.346|
71060342|NCT02360215|141628193|SUPERIORITY||||||<|0.0001|||||||Regression, Cox|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part B (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline TMT Part B is reported here.||||<0.0001
71060343|NCT02360215|141628194|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with COWA (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline COWA is reported here.||||<0.0001
71060344|NCT02360215|141628194|SUPERIORITY|||||||0.9749|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with COWA (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.9749
70936424|NCT01263496|141373301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.277|||||TWO_SIDED|95.0|-0.539|-0.015||||||||-0.015|-0.539|
71060345|NCT02360215|141628194|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with COWA (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here. is reported here.||||<0.0001
71060346|NCT02360215|141628195|SUPERIORITY|||||||0.2552|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with the neurocognitive composite score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.2552
70936425|NCT01263496|141373301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.373|||||TWO_SIDED|95.0|-0.637|-0.109||||||||-0.109|-0.637|
70936426|NCT01263496|141373301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.477|||||TWO_SIDED|95.0|-0.741|-0.213||||||||-0.213|-0.741|
70936427|NCT01263496|141373302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.181|||||TWO_SIDED|95.0|-0.416|0.055||||||||0.055|-0.416|
70936428|NCT01263496|141373302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.245|||||TWO_SIDED|95.0|-0.492|0.003||||||||0.003|-0.492|
70936429|NCT01263496|141373302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.408|||||TWO_SIDED|95.0|-0.654|-0.161||||||||-0.161|-0.654|
71060347|NCT02360215|141628195|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with the neurocognitive composite score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here.||||<0.0001
71060348|NCT02360215|141628195|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with the neurocognitive composite score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline composite score is reported here.||||<0.0001
70936430|NCT01263496|141373302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.638|||||TWO_SIDED|95.0|-0.874|-0.402||||||||-0.402|-0.874|
70936431|NCT01263496|141373303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.51|||||TWO_SIDED|95.0|-17.56|0.54||||||||0.54|-17.56|
70936432|NCT01263496|141373303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.7|||||TWO_SIDED|95.0|-19.23|-4.18||||||||-4.18|-19.23|
70936433|NCT01263496|141373303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.41|||||TWO_SIDED|95.0|-20.68|-6.15||||||||-6.15|-20.68|
70936434|NCT01263496|141373303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.38|||||TWO_SIDED|95.0|-26.93|-11.83||||||||-11.83|-26.93|
70936435|NCT01263496|141373304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.44|||||TWO_SIDED|95.0|-12.67|3.8||||||||3.80|-12.67|
70936436|NCT01263496|141373304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.39|||||TWO_SIDED|95.0|-17.48|-1.3||||||||-1.30|-17.48|
70936437|NCT01263496|141373304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.56|||||TWO_SIDED|95.0|-18.58|-2.54||||||||-2.54|-18.58|
70936438|NCT01263496|141373304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.37|||||TWO_SIDED|95.0|-21.44|-3.31||||||||-3.31|-21.44|
70936439|NCT01263496|141373305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.9|||||TWO_SIDED|95.0|-15.66|1.86||||||||1.86|-15.66|
71060349|NCT02360215|141628196|SUPERIORITY|||||||0.57|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Symptom Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.57
71060350|NCT02360215|141628196|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Symptom Severity score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline symptom severity is reported here.||||<0.0001
71060351|NCT02360215|141628196|SUPERIORITY|||||||0.083|||||||Mixed Models Analysis|||A two-sample t-test with a 2-sided type I error of 0.05 provides \>90% statistical power to detect a medium effect size of 0.5 for a comparison of the change from baseline to 6 months from the start of treatment. The comparison at six months was tested within a mixed effects model with covariates age, RPA class, prior radiosurgery, prior surgical resection, baseline score, treatment arm, and time was used.||||0.083
71060352|NCT02360215|141628197|SUPERIORITY|||||||0.9118|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Interference Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.9118
71060353|NCT02360215|141628197|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Interference Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline interference score is reported here.||||<0.0001
71060354|NCT02360215|141628198|SUPERIORITY|||||||0.1964|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Cognitive Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.1964
71060355|NCT02360215|141628198|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Cognitive Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline cognitive factor score is reported here.||||<0.0001
71060356|NCT02360215|141628198|SUPERIORITY|||||||0.0032|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Cognitive Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Prior radiotherapy (yes vs. no) is reported here.||||0.0032
71109707|NCT01334554|141724426|SUPERIORITY_OR_OTHER||Beta coefficient (linear regression)|0.12||||0.55|TWO_SIDED|95.0|-0.33|0.58||p- value was unadjusted. Primary outcome underwent logarithmic transformation|Regression, Linear|||H0= 4-week treatment with sildenafil citrate does not improve insulin sensitivity in obese African American women.||0.58|-0.33|0.55
71109708|NCT01334554|141724427|SUPERIORITY_OR_OTHER||Beta coefficient|0.46||||0.649|TWO_SIDED|95.0|-1.58|2.49||Adjusted for baseline values only|Regression, Linear|||||2.49|-1.58|0.649
71109709|NCT02393859|141724442|SUPERIORITY||Normal score|-11.54|||<|0.001||||||Stratification factors were: age (1 to 9 years vs other \[\< 1 year and \> 9 years\]), and marrow/MRD status (M1 with MRD level \< 10\^-3 vs M1 with MRD level ≥ 10\^-3 vs M2).|Stratified log-rank test||A normal score \< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.|||||< 0.001
70936440|NCT01263496|141373305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.73|||||TWO_SIDED|95.0|-18.97|-2.49||||||||-2.49|-18.97|
70936441|NCT01263496|141373305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.21|||||TWO_SIDED|95.0|-17.2|-1.23||||||||-1.23|-17.20|
70936442|NCT01263496|141373305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.49|||||TWO_SIDED|95.0|-24.27|-6.72||||||||-6.72|-24.27|
70936443|NCT01263496|141373306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.27|||||TWO_SIDED|95.0|-11.22|6.67||||||||6.67|-11.22|
70936444|NCT01263496|141373306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.36|||||TWO_SIDED|95.0|-12.16|5.44||||||||5.44|-12.16|
70936445|NCT01263496|141373306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.43|||||TWO_SIDED|95.0|-13.3|2.44||||||||2.44|-13.30|
70936446|NCT01263496|141373306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.9|||||TWO_SIDED|95.0|-20.74|-3.06||||||||-3.06|-20.74|
71060357|NCT02360215|141628199|SUPERIORITY|||||||0.8877|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Neurologic Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.8877
71060358|NCT02360215|141628199|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Neurologic Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline neurologic factor is reported here.||||<0.0001
71060359|NCT02360215|141628199|SUPERIORITY|||||||0.0078|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Neurologic Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here.||||0.0078
71060360|NCT02360215|141628200|SUPERIORITY|||||||0.86||||||Significance level = 0.05|t-test, 2 sided|||||||0.86
71060361|NCT02360215|141628202|SUPERIORITY|||||||0.95||||||Significance level = 0.05|t-test, 2 sided|||||||0.95
71060362|NCT02360215|141628203|SUPERIORITY|||||||0.66||||||Significance level = 0.05|t-test, 2 sided|||||||0.66
71060363|NCT02360215|141628204|SUPERIORITY|||||||0.18||||||Significance level = 0.05|t-test, 2 sided|||||||0.18
70936447|NCT01263496|141373307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.44|||||TWO_SIDED|95.0|-11.97|7.08||||||||7.08|-11.97|
71060364|NCT02360215|141628205|SUPERIORITY|||||||0.64||||||Significance level = 0.05|t-test, 2 sided|||||||0.64
71060365|NCT02360215|141628206|SUPERIORITY|||||||0.91||||||Significance level = 0.05|t-test, 2 sided|||||||0.91
71060366|NCT02360215|141628207|OTHER|||||||0.92||||||Significance level = 0.05|t-test, 2 sided|||||||0.92
71060367|NCT02360215|141628208|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.076|TWO_SIDED|95.0|0.98|1.47||Two-sided significance level = 0.05|Log Rank||Reference level = WBRT + Memantine|||1.47|0.98|0.076
71109710|NCT02393859|141724442|SUPERIORITY||Normal score|-11.16||||0.001|||||||Unstratified log-rank test||A normal score \< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.|||||0.001
71109711|NCT02393859|141724442|SUPERIORITY||Stratified hazard ratio (HR)|0.36|||||TWO_SIDED|95.0|0.19|0.66|||||Cox proportional hazard model. Stratification factors were: age and marrow/MRD status. (HR \< 1.0 indicates a lower average event rate and a longer EFS for blinatumomab relative to HC3.)|||0.66|0.19|
71060368|NCT02360215|141628209|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.242|TWO_SIDED|95.0|0.91|1.43||Two-sided significance level = 0.05|Log Rank||Reference level = WBRT + Memantin|||1.43|0.91|0.242
71060369|NCT02360215|141628210|SUPERIORITY|||||||0.47||||||Two-sided p-value = 0.05|Chi-squared|||||||0.47
71060370|NCT02603146|141628215|OTHER||Cumulative Probability|0.336|||||TWO_SIDED|95.0|0.213|0.459|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of CL-RA by Month 36 for HCQ.|||0.459|0.213|
71060371|NCT02603146|141628215|OTHER||Cumulative Probability|0.394|||||TWO_SIDED|95.0|0.268|0.519|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of CL-RA by Month 36 for Placebo.|||0.519|0.268|
71060372|NCT02603146|141628215|SUPERIORITY|"The analysis is based on the KM estimated risk of CL- RA at 36 months, where risk = (1-KM estimated probability of survival). Survival for this analysis is defined as absence of CL-RA. Estimated risks were derived from a Kaplan-Meier curve using censored time-to-event data to account for attrition under the assumption of non-informative censoring."|Risk Difference (RD)|-0.058||||0.522|TWO_SIDED|95.0|-0.336|0.22||The test statistic is a Wald-type chi-square statistic derived by dividing the difference of the logit-transformed KM survival estimates for each arm by the associated variance derived using the delta-method \[Klein, et. al. 2007\].|Chi-squared||Risk difference for HCQ - Placebo|||0.220|-0.336|0.522
71060373|NCT02603146|141628216|OTHER||Cumulative Probability|0.165|||||TWO_SIDED|95.0|0.076|0.225|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of CL-RA by Month 12 for HCQ.|||0.225|0.076|
71060374|NCT02603146|141628216|OTHER||Cumulative Probability|0.194|||||TWO_SIDED|95.0|0.099|0.289|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of CL-RA by Month 12 for Placebo.|||0.289|0.099|
71060375|NCT02603146|141628216|SUPERIORITY|"The analysis is based on the KM estimated risk of CL- RA at 12 months, where risk = (1-KM estimated probability of survival). Survival for this analysis is defined as absence of CL-RA. Estimated risks were derived from a Kaplan-Meier curve using censored time-to-event data to account for attrition under the assumption of non-informative censoring."|Risk Difference (RD)|-0.029||||0.668|TWO_SIDED|95.0|-0.188|0.131||The test statistic is a Wald-type chi-square statistic derived by dividing the difference of the logit-transformed KM survival estimates for each arm by the associated variance derived using the delta-method \[Klein, et. al. 2007\].|Chi-squared||Risk difference for HCQ - Placebo|||0.131|-0.188|0.668
71060376|NCT02603146|141628217|OTHER||Cumulative Probability|0.18|||||TWO_SIDED|95.0|0.088|0.273|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of IA by Month 12 for HCQ.|||0.273|0.088|
71109712|NCT02393859|141724442|SUPERIORITY||Unstratified HR|0.39|||||TWO_SIDED|95.0|0.22|0.7|||||Cox proportional hazard model. (HR \< 1.0 indicates a lower average event rate and a longer EFS for blinatumomab relative to HC3.)|||0.70|0.22|
71109713|NCT02393859|141724442|SUPERIORITY||Stratified HR w/time-dependent covariate|0.36|||||TWO_SIDED|95.0|0.2|0.64|||||Cox proportional hazard model including time from randomization to allogeneic hematopoietic stem cell transplant. Stratification factors: age and marrow/MRD status. (HR \<1.0=lower average event rate and longer EFS for blinatumomab relative to HC3.)|||0.64|0.20|
71060377|NCT02603146|141628217|OTHER||Cumulative Probability|0.194|||||TWO_SIDED|95.0|0.099|0.289|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of IA by Month 12 for Placebo.|||0.289|0.099|
71060378|NCT02603146|141628217|SUPERIORITY|"The analysis is based on the KM estimated risk of IA at 12 months, where risk = (1-KM estimated probability of survival). Survival for this analysis is defined as absence of IA. Estimated risks were derived from a Kaplan-Meier curve using censored time-to-event data to account for attrition under the assumption of non-informative censoring."|Risk Difference (RD)|-0.014||||0.84|TWO_SIDED|95.0|-0.177|0.15||The test statistic is a Wald-type chi-square statistic derived by dividing the difference of the logit-transformed KM survival estimates for each arm by the associated variance derived using the delta-method \[Klein, et. al. 2007\].|Chi-squared||Risk difference for HCQ - Placebo|||0.150|-0.177|0.840
71060379|NCT02603146|141628218|SUPERIORITY|||||||0.652|||||||Log Rank|||||||0.652
71060380|NCT02603146|141628219|OTHER||Cumulative Probability|0.356|||||TWO_SIDED|95.0|0.23|0.482|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of IA by Month 36 for HCQ.|||0.482|0.230|
71060381|NCT02603146|141628219|OTHER||Cumulative Probability|0.425|||||TWO_SIDED|95.0|0.298|0.551|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of IA by Month 36 for Placebo.|||0.551|0.298|
71060382|NCT02603146|141628219|SUPERIORITY|"The analysis is based on the KM estimated risk of IA at 36 months, where risk = (1-KM estimated probability of survival). Survival for this analysis is defined as absence of IA. Estimated risks were derived from a Kaplan-Meier curve using censored time-to-event data to account for attrition under the assumption of non-informative censoring."|Risk Difference (RD)|-0.069||||0.452|TWO_SIDED|95.0|-0.363|0.226||The test statistic is a Wald-type chi-square statistic derived by dividing the difference of the logit-transformed KM survival estimates for each arm by the associated variance derived using the delta-method \[Klein, et. al. 2007\].|Chi-squared||Risk difference for HCQ - Placebo|||0.226|-0.363|0.452
71060383|NCT02603146|141628220|SUPERIORITY|||||||0.928||||||Week 52 results|Wilcoxon (Mann-Whitney)|||||||0.928
71060384|NCT02603146|141628220|SUPERIORITY|||||||0.076||||||Month 36 results|Wilcoxon (Mann-Whitney)|||||||0.076
71060385|NCT02603146|141628221|SUPERIORITY|||||||0.781||||||Week 52 results|Wilcoxon (Mann-Whitney)|||||||0.781
71060386|NCT02603146|141628221|SUPERIORITY|||||||0.457||||||Month 36 results|Wilcoxon (Mann-Whitney)|||||||0.457
71060387|NCT02603146|141628222|SUPERIORITY|||||||0.576||||||Week 52 results|Wilcoxon (Mann-Whitney)|||||||0.576
71060388|NCT02603146|141628222|SUPERIORITY|||||||0.323||||||Month 36 results|Wilcoxon (Mann-Whitney)|||||||0.323
71060389|NCT02603146|141628223|SUPERIORITY|||||||0.865||||||Week 52 results|Wilcoxon (Mann-Whitney)|||||||0.865
71060390|NCT02603146|141628223|SUPERIORITY|||||||0.179||||||Month 36 results|Wilcoxon (Mann-Whitney)|||||||0.179
71060391|NCT02603146|141628224|SUPERIORITY|||||||0.634||||||Week 52 results|Wilcoxon (Mann-Whitney)|||||||0.634
71060392|NCT02603146|141628224|SUPERIORITY|||||||0.574||||||Month 36 results|Wilcoxon (Mann-Whitney)|||||||0.574
71060393|NCT02603146|141628225|SUPERIORITY|||||||0.724||||||Week 52 results|Wilcoxon (Mann-Whitney)|||||||0.724
71060394|NCT02603146|141628225|SUPERIORITY|||||||0.149||||||Month 36 results|Wilcoxon (Mann-Whitney)|||||||0.149
71060395|NCT02603146|141628229|SUPERIORITY|||||||0.809|||||||Fisher Exact|||||||0.809
71060396|NCT01332487|141628264|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Acute Urinary Retention|Chi-squared|||||||0.002
71060397|NCT01332487|141628264|SUPERIORITY_OR_OTHER|||||||0||95.0||||Surgery|Chi-squared|||||||0.000
71060398|NCT01332487|141628264|SUPERIORITY_OR_OTHER|||||||0.597||95.0||||Emergency Surgery|Chi-squared|||||||0.597
71060399|NCT01999920|141628298|SUPERIORITY|||||||0.064|||||||Mixed Models Analysis|||||||.064
71060400|NCT01999920|141628299|SUPERIORITY||Standard error|5.5|STANDARD_ERROR_OF_MEAN|3.13||0.11|TWO_SIDED|95.0|-1.32|12.32|||Mixed Models Analysis|||||12.32|-1.32|0.11
71060401|NCT01999920|141628300|SUPERIORITY||Standard error|0.34|STANDARD_ERROR_OF_MEAN|2.44||0.89|TWO_SIDED|95.0|-4.85|5.53|||Mixed Models Analysis|||Confidence variable||5.53|-4.85|0.89
71060402|NCT01999920|141628300|SUPERIORITY||Standard error|1.18|STANDARD_ERROR_OF_MEAN|4.41||0.79|TWO_SIDED|95.0|-8.21|10.58|||Mixed Models Analysis|||Discomfort with Closeness variable||10.58|-8.21|0.79
71060403|NCT01999920|141628300|SUPERIORITY||Standard error|3.94|STANDARD_ERROR_OF_MEAN|3.79||0.31|TWO_SIDED|95.0|-4.12|12.01|||Mixed Models Analysis|||Relationships as Secondary variable||12.01|-4.12|0.31
71060404|NCT01999920|141628300|SUPERIORITY||Standard error|-2.6|STANDARD_ERROR_OF_MEAN|1.49||0.1|TWO_SIDED|95.0|-5.79|0.58|||Mixed Models Analysis|||Need for Approval variable||0.58|-5.79|0.10
71060405|NCT01999920|141628300|SUPERIORITY||Standard error|0.71|STANDARD_ERROR_OF_MEAN|2.82||0.8|TWO_SIDED|95.0|-5.3|6.72|||Mixed Models Analysis|||Preoccupation with Relationships variable||6.72|-5.30|0.80
71060406|NCT01999920|141628301|SUPERIORITY||Standard error|-19.91|STANDARD_ERROR_OF_MEAN|6.99||0.008|TWO_SIDED|95.0|-34.23|-5.58|||Mixed Models Analysis|||||-5.58|-34.23|0.008
71060407|NCT01999920|141628302|SUPERIORITY||Standard error|3.29|STANDARD_ERROR_OF_MEAN|1.43||0.026|TWO_SIDED|95.0|0.42|6.16|||Mixed Models Analysis|||||6.16|0.42|0.026
70936448|NCT01263496|141373307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.25|||||TWO_SIDED|95.0|-15.84|3.35||||||||3.35|-15.84|
71060408|NCT01999920|141628303|SUPERIORITY||Standard error|21.38|STANDARD_ERROR_OF_MEAN|7.65||0.01|TWO_SIDED|95.0|5.64|37.11|||Mixed Models Analysis|||||37.11|5.64|0.01
71060409|NCT01958437|141628318|SUPERIORITY|||||||0.048|||||||ANCOVA|||RM ANCOVA (covarying order) for cognitively intact groups||||.048
71060410|NCT01958437|141628318|SUPERIORITY|||||||0.063|||||||ANCOVA|||RM ANCOVA (covarying order) for MCI group||||.063
71060411|NCT01958437|141628319|SUPERIORITY|||||||0.27|||||||ANCOVA|Main effect of stimulation covarying session order||Change between active and sham tDCS sessions for allocentric blocks||||.27
71060412|NCT01958437|141628319|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<.001
70936449|NCT01263496|141373307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.93|||||TWO_SIDED|95.0|-15.28|1.41||||||||1.41|-15.28|
70936450|NCT01263496|141373307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.73|||||TWO_SIDED|95.0|-22.67|-2.78||||||||-2.78|-22.67|
70936451|NCT01263496|141373308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.44|||||TWO_SIDED|95.0|-13.19|2.31||||||||2.31|-13.19|
70936452|NCT01263496|141373308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.77|||||TWO_SIDED|95.0|-13.53|5.99||||||||5.99|-13.53|
70936453|NCT01263496|141373308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.85|||||TWO_SIDED|95.0|-14.36|2.67||||||||2.67|-14.36|
70936454|NCT01263496|141373308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.22|||||TWO_SIDED|95.0|-20.72|-1.73||||||||-1.73|-20.72|
70936455|NCT01263496|141373309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.26|||||TWO_SIDED|95.0|-10.42|5.9||||||||5.90|-10.42|
70936456|NCT01263496|141373309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|||||TWO_SIDED|95.0|-15.64|3.84||||||||3.84|-15.64|
70936457|NCT01263496|141373309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.47|||||TWO_SIDED|95.0|-16.52|-0.42||||||||-0.42|-16.52|
70936458|NCT01263496|141373309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.47|||||TWO_SIDED|95.0|-22.18|-2.76||||||||-2.76|-22.18|
70936459|NCT01263496|141373310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34|||||TWO_SIDED|95.0|-7.1|7.77||||||||7.77|-7.10|
70936460|NCT01263496|141373310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98|||||TWO_SIDED|95.0|-10.16|8.21||||||||8.21|-10.16|
70936461|NCT01263496|141373310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88|||||TWO_SIDED|95.0|-9.71|5.95||||||||5.95|-9.71|
71060413|NCT01958437|141628320|SUPERIORITY||||||<|0.001|||||||ANCOVA|Main effect of session using repeated measures ANCOVA covarying stimulation order||||||<.001
71060414|NCT01958437|141628320|SUPERIORITY|||||||0.046|||||||ANCOVA|Main effect of session using repeated measures ANCOVA covarying stimulation order||||||.046
71060415|NCT01958437|141628321|SUPERIORITY|||||||0.497|||||||ANCOVA|||Repeated Measures ANCOVA (covarying stimulation order)||||.497
71060416|NCT01958437|141628321|SUPERIORITY|||||||0.599|||||||ANCOVA|||||||.599
71060417|NCT04886596|141628330|OTHER|VE is demonstrated if the lower limit (LL) of the 2-sided confidence interval (CI) for vaccine efficacy (VE) is above 20%.|VE|82.58|||||TWO_SIDED|96.95|57.89|94.08|||Poisson regression method||VE in terms of occurrence of RSV-confirmed LRTD was evaluated using the conditional exact binomial method based on the Poisson model|To demonstrate the vaccine efficacy (VE) efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD during the first season in adults ≥ 60 YOA||94.08|57.89|
70936462|NCT01263496|141373310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.38|||||TWO_SIDED|95.0|-18.59|-0.18||||||||-0.18|-18.59|
70936463|NCT01263496|141373311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|||||TWO_SIDED|95.0|-10.2|6.75||||||||6.75|-10.20|
70936464|NCT01263496|141373311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7|||||TWO_SIDED|95.0|-13.1|5.7||||||||5.70|-13.10|
71060418|NCT04886596|141628331|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 20%.|VE|62.91|||||TWO_SIDED|97.5|46.74|74.79|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over three seasons.||74.79|46.74|
71109714|NCT02393859|141724443|SUPERIORITY||Normal score|-13.9|||<|0.001||||||Stratification factors were: age (1 to 9 years vs other \[\< 1 year and \> 9 years\]), and marrow/MRD status (M1 with MRD level \< 10\^-3 vs M1 with MRD level ≥ 10\^-3 vs M2).|Stratified log-rank test||A normal score \< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.|||||< 0.001
70936465|NCT01263496|141373311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.97|||||TWO_SIDED|95.0|-12.94|5.0||||||||5.00|-12.94|
70936466|NCT01263496|141373311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.74|||||TWO_SIDED|95.0|-19.4|-0.08||||||||-0.08|-19.40|
70936467|NCT01263496|141373312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.43|||||TWO_SIDED|95.0|-11.0|6.15||||||||6.15|-11.00|
70936468|NCT01263496|141373312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.29|||||TWO_SIDED|95.0|-16.53|1.94||||||||1.94|-16.53|
70936469|NCT01263496|141373312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.3|||||TWO_SIDED|95.0|-17.93|-0.67||||||||-0.67|-17.93|
70936470|NCT01263496|141373312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.88|||||TWO_SIDED|95.0|-21.83|-1.93||||||||-1.93|-21.83|
70936471|NCT01263496|141373313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-9.68|7.27||||||||7.27|-9.68|
70936472|NCT01263496|141373313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.05|||||TWO_SIDED|95.0|-16.34|2.24||||||||2.24|-16.34|
70936473|NCT01263496|141373313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.86|||||TWO_SIDED|95.0|-17.47|-0.26||||||||-0.26|-17.47|
70936474|NCT01263496|141373313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.51|||||TWO_SIDED|95.0|-23.12|-3.89||||||||-3.89|-23.12|
70936475|NCT01263496|141373314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.65|||||TWO_SIDED|95.0|-10.09|6.8||||||||6.80|-10.09|
70936476|NCT01263496|141373314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||||TWO_SIDED|95.0|-15.66|2.25||||||||2.25|-15.66|
70936477|NCT01263496|141373314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.28|||||TWO_SIDED|95.0|-16.64|0.07||||||||0.07|-16.64|
70936478|NCT01263496|141373314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.82|||||TWO_SIDED|95.0|-27.39|-10.24||||||||-10.24|-27.39|
70936479|NCT01263496|141373315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.017|||||TWO_SIDED|95.0|-0.219|0.254||||||||0.254|-0.219|
70936480|NCT01263496|141373315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|||||TWO_SIDED|95.0|0.002|0.451||||||||0.451|0.002|
70936481|NCT01263496|141373315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||||TWO_SIDED|95.0|0.008|0.453||||||||0.453|0.008|
70936482|NCT01263496|141373315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.282|||||TWO_SIDED|95.0|0.041|0.524||||||||0.524|0.041|
70936483|NCT01263496|141373316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|||||TWO_SIDED|95.0|-0.173|0.353||||||||0.353|-0.173|
70936484|NCT01263496|141373316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.228|||||TWO_SIDED|95.0|-0.01|0.467||||||||0.467|-0.010|
70936485|NCT01263496|141373316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.339|||||TWO_SIDED|95.0|0.095|0.584||||||||0.584|0.095|
71109715|NCT02393859|141724443|SUPERIORITY||Normal score|-13.61|||<|0.001|||||||Unstratified log-rank test||A normal score \< 0 indicates fewer than expected events for Blinatumomab relative to HC3 and therefore a longer event free survival time.|||||< 0.001
71109716|NCT02393859|141724443|SUPERIORITY||Stratified HR|0.35|||||TWO_SIDED|95.0|0.2|0.61|||||Cox proportional hazard model. Stratification factors were: age and marrow/MRD status. (HR \< 1.0 indicates a lower average event rate and a longer EFS for blinatumomab relative to HC3.)|||0.61|0.20|
71109717|NCT02393859|141724443|SUPERIORITY||Unstratified HR|0.38|||||TWO_SIDED|95.0|0.22|0.65|||||Cox proportional hazard model. (HR \< 1.0 indicates a lower average event rate and a longer EFS for blinatumomab relative to HC3.)|||0.65|0.22|
71109718|NCT02393859|141724443|SUPERIORITY||Stratified HR w/time-dependent covariate|0.34|||||TWO_SIDED|95.0|0.2|0.59|||||Cox proportional hazard model including time from randomization to allogeneic hematopoietic stem cell transplant. Stratification factors: age and marrow/MRD status. (HR \<1.0=lower average event rate and longer EFS for blinatumomab relative to HC3.)|||0.59|0.20|
71109719|NCT02393859|141724444|SUPERIORITY||Normal score|-10.14||||0.001||||||Stratification factors were: age (1 to 9 years vs other \[\< 1 year and \> 9 years\]), and marrow/MRD status (M1 with MRD level \< 10\^-3 vs M1 with MRD level ≥ 10\^-3 vs M2).|Stratified log-rank test||A normal score \< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.|||||0.001
71109720|NCT02393859|141724444|SUPERIORITY||Normal score|-10.32|||<|0.001|||||||Unstratified log-rank test||A normal score \< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.|||||< 0.001
71109721|NCT02393859|141724444|SUPERIORITY||Stratified HR|0.33|||||TWO_SIDED|95.0|0.16|0.66|||||Cox proportional hazard model. Stratification factors were: age and marrow/MRD status. (HR \< 1.0 indicates a lower average event rate and a longer survival for blinatumomab relative to HC3.)|||0.66|0.16|
71109722|NCT02393859|141724444|SUPERIORITY||Unstratified HR|0.32|||||TWO_SIDED|95.0|0.16|0.65|||||Cox proportional hazard model. (HR \< 1.0 indicates a lower average event rate and a longer survival for blinatumomab relative to HC3.)|||0.65|0.16|
71109723|NCT02393859|141724445|SUPERIORITY||||||<|0.001||||||Cochran-Mantel-Haenszel test adjusting for the stratification factors: age (1 to 9 years vs other \[\< 1 year and \> 9 years\]), and marrow/MRD status (M1 with MRD level \< 10\^-3 vs M1 with MRD level ≥ 10\^-3 vs M2).|Cochran-Mantel-Haenszel|||MRD response by PCR||||< 0.001
71109724|NCT02393859|141724445|SUPERIORITY||||||<|0.001||||||Cochran-Mantel-Haenszel test adjusting for the stratification factors: age (1 to 9 years vs other \[\< 1 year and \> 9 years\]), and marrow/MRD status (M1 with MRD level \< 10-3 vs M1 with MRD level ≥ 10-3 vs M2).|Cochran-Mantel-Haenszel|||MRD response by flow cytometry||||< 0.001
71109725|NCT02393859|141724446|SUPERIORITY||Hazard Ratio (HR)|0.29|||||TWO_SIDED|95.0|0.16|0.52|||||The subdistribution HR estimates are obtained from the subdistribution Cox model. (HR \< 1.0 indicates a lower average event rate and a longer relapse-free time for blinatumomab relative to HC3.)|||0.52|0.16|
71109726|NCT02393859|141724446|SUPERIORITY||Stratified hazard ratio (HR)|0.27|||||TWO_SIDED|95.0|0.15|0.48|||||The subdistribution HR estimates are obtained from the subdistribution Cox model. (HR \< 1.0 indicates a lower average event rate and a longer relapse-free time for blinatumomab relative to HC3.) Stratification factors are age and marrow/MRD status.|||0.48|0.15|
71109727|NCT00954447|141724454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.74|-0.55|||ANCOVA||Linagliptin 5mg - Placebo|||-0.55|-0.74|<0.0001
71109728|NCT00954447|141724455|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.935|||<|0.0001||95.0|1.949|4.419|||Regression, Logistic|Logistic regression of HbA1c \< 7.0 percent at week 52|Linagliptin 5mg vs. Placebo OR adjusted for baseline HbA1c, categorical renal function impairment, concomitant OADs and treatment|FAS with baseline HbA1c \>= 7.0 percent (NCF); there are 593 available values for Placebo and 595 for Linagliptin 5mg||4.419|1.949|<0.0001
70936486|NCT01263496|141373316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.468|||||TWO_SIDED|95.0|0.184|0.752||||||||0.752|0.184|
71109729|NCT00954447|141724457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|-0.51|-0.39|||ANCOVA||Linagliptin 5mg - Placebo|||-0.39|-0.51|<0.0001
71109730|NCT00954447|141724458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|-0.69|-0.52|||ANCOVA||Linagliptin 5mg - Placebo|||-0.52|-0.69|<0.0001
71109731|NCT00954447|141724459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.76|-0.57|||ANCOVA||Linagliptin 5mg - Placebo|||-0.57|-0.76|<0.0001
71109732|NCT00954447|141724460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.67|-0.47|||ANCOVA||Linagliptin 5mg - Placebo|||-0.47|-0.67|<0.0001
71109733|NCT00954447|141724461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.65|-0.45|||ANCOVA||Linagliptin 5mg - Placebo|||-0.45|-0.65|<0.0001
71109734|NCT00954447|141724462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.64|-0.43|||ANCOVA||Linagliptin 5mg - Placebo|||-0.43|-0.64|<0.0001
71109735|NCT00954447|141724463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|2.49|<|0.0001||95.0|-16.49|-6.71|||ANCOVA||Linagliptin 5mg - Placebo|||-6.71|-16.49|<0.0001
71109736|NCT00954447|141724466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|0.53||0.0029||95.0|-2.61|-0.54|||ANCOVA||Linagliptin 5mg - Placebo|||-0.54|-2.61|0.0029
71109737|NCT00954447|141724469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.327|||<|0.0001||95.0|2.221|8.43|||Regression, Logistic|Logistic regression of HbA1c \< 6.5 percent at week 52|Linagliptin 5mg vs. Placebo OR adjusted for baseline HbA1c, categorical renal function impairment, concomitant OADs and treatment|FAS with baseline HbA1c \>= 6.5 percent (NCF); there are 615 available values for Placebo and 616 for Linagliptin 5mg||8.430|2.221|<0.0001
71117637|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
71060419|NCT04886596|141628331|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 20%.|VE|67.18|||||TWO_SIDED|97.5|48.19|80.04|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over two seasons.||80.04|48.19|
71060420|NCT04886596|141628332|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 20%.|VE|67.76|||||TWO_SIDED|97.5|51.82|79.11|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine followed by 1 annual revaccination before Season 2 in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over three seasons.||79.11|51.82|
71060421|NCT04886596|141628332|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 20%.|VE|67.12|||||TWO_SIDED|97.5|48.09|80.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine followed by 1 annual revaccination before Season 2 in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over two seasons.||80.00|48.09|
71060422|NCT04886596|141628333|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 0%.|VE|69.83|||||TWO_SIDED|97.5|42.18|85.72|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD for RSV subtype A in adults ≥ 60 YOA over 3 seasons.||85.72|42.18|
71060423|NCT04886596|141628333|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 0%.|VE|58.57|||||TWO_SIDED|97.5|35.9|74.11|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD for RSV subtype B in adults ≥ 60 YOA over 3 seasons.||74.11|35.90|
71060424|NCT04886596|141628334|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 0%.|VE|55.12|||||TWO_SIDED|97.5|16.52|77.52|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose and 1 annual revaccination before Season 2 of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD for RSV subtype A in adults ≥ 60 YOA over 3 seasons.||77.52|16.52|
71060425|NCT04886596|141628334|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 0%.|VE|73.58|||||TWO_SIDED|97.5|55.1|85.4|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose and 1 annual revaccination before Season 2 of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD for RSV subtype B in adults ≥ 60 YOA over 3 seasons.||85.40|55.10|
71060426|NCT04886596|141628335|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|18.41|||||TWO_SIDED|95.0|-19.1|44.33|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season)|To evaluate vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hMPV-confirmed LRTD in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine up to the end of Season 1.||44.33|-19.10|
71060427|NCT04886596|141628336|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|58.78|||||TWO_SIDED|95.0|40.73|71.96|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=65YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||71.96|40.73|
71060428|NCT04886596|141628336|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|65.98|||||TWO_SIDED|95.0|44.32|80.16|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=70YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||80.16|44.32|
71117638|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
71117639|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
71060429|NCT04886596|141628336|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|36.24|||||TWO_SIDED|95.0|-93.99|82.47|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=80YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||82.47|-93.99|
71060430|NCT04886596|141628336|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|66.56|||||TWO_SIDED|95.0|49.33|78.64|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=65YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||78.64|49.33|
71060431|NCT04886596|141628336|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|64.25|||||TWO_SIDED|95.0|40.49|79.55|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=70YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine at end of season 3.||79.55|40.49|
71060432|NCT04886596|141628336|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|32.81|||||TWO_SIDED|95.0|-108.42|81.73|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=80YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine at end of season 3.||81.73|-108.42|
71060433|NCT04886596|141628337|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|80.64|||||TWO_SIDED|95.0|55.9|92.73|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 1 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||92.73|55.90|
71060434|NCT04886596|141628337|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|61.39|||||TWO_SIDED|95.0|36.44|77.7|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 2 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||77.70|36.44|
71060435|NCT04886596|141628337|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|47.15|||||TWO_SIDED|95.0|7.06|71.59|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 3 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||71.59|7.06|
71060436|NCT04886596|141628337|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|54.92|||||TWO_SIDED|95.0|27.85|72.98|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 2 in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||72.98|27.85|
71060437|NCT04886596|141628337|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|67.51|||||TWO_SIDED|95.0|22.35|88.79|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 3 in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||88.79|22.35|
71060438|NCT04886596|141628338|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|78.86|||||TWO_SIDED|95.0|57.62|90.48|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 1 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||90.48|57.62|
70936487|NCT01263496|141373317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.317|||||TWO_SIDED|95.0|0.064|0.57||||||||0.570|0.064|
71060439|NCT04886596|141628338|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|58.59|||||TWO_SIDED|95.0|34.0|75.1|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 2 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||75.10|34.00|
70852307|NCT03060551|141193186|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.38||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.380
71060440|NCT04886596|141628338|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|47.91|||||TWO_SIDED|95.0|8.51|71.97|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 3 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||71.97|8.51|
71060441|NCT04886596|141628338|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|58.33|||||TWO_SIDED|95.0|33.59|74.94|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 2 in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||74.94|33.59|
70852308|NCT01809639|141193193|SUPERIORITY_OR_OTHER|||||||0.42|||||||ANOVA|||||||.42
71060442|NCT04886596|141628338|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|68.4|||||TWO_SIDED|95.0|24.64|89.08|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 3 in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||89.08|24.64|
70852309|NCT01379508|141193203|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was derived if the lower limit of two-sided 95% CI for the difference lied above the pre-determined non-inferiority margin (-10%).|Difference in percentage|-4.0|||||TWO_SIDED|95.0|-10.5|2.5||||||Missing DNA data at Wk 52=failure: To evaluate the primary objective, Mantel-Haenszel weighted estimates approach (stratified by HBV DNA level (\< 7 log10 copies/mL or ≥ 7 log10 copies/mL) and ALT (\< 3×ULN or ≥ 3×ULN) at baseline) was employed to assess the proportion of patients (response rate) who achieve HBV DNA \< 300 copies/mL after 52 weeks treatment in each treatment arm, as well as the difference in proportions (telbivudine - tenofovir arm) and the 95% CI of the difference.||2.5|-10.5|
70852310|NCT01379508|141193203|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was derived if the lower limit of two-sided 95% CI for the difference was above the pre-determined non-inferiority margin (-10%).|Difference in percentage|-3.1|||||TWO_SIDED|95.0|-9.4|3.1||||||Imputing +/- 7 days DNA for Wk 52: To evaluate the primary objective, Mantel-Haenszel weighted estimates approach (stratified by HBV DNA level (\< 7 log10 copies/mL or ≥ 7 log10 copies/mL) and ALT (\< 3×ULN or ≥ 3×ULN) at baseline) was employed to assess the proportion of patients (response rate) who achieve HBV DNA \< 300 copies/mL after 52 weeks treatment in each treatment arm, as well as the difference in proportions (telbivudine - tenofovir arm) and the 95% CI of the difference.||3.1|-9.4|
70852311|NCT01379508|141193203|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was derived if the lower limit of two-sided 95% CI for the difference lied above the pre-determined non-inferiority margin (-10%).|Difference in percentage|-3.8|||||TWO_SIDED|95.0|-7.9|0.4||||||Imputing LOCF DNA for wk 52: d/c for non response prior to Wk 52: Treating missing as failure for patients who discontinued prior to Week 52 due to unsatisfactory therapeutic effect and imputing missing with LOCF for other patients||0.4|-7.9|
70852312|NCT01379508|141193203|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was derived if the lower limit of two-sided 95% CI for the difference lied above the pre-determined non-inferiority margin (-10%).|Difference in percentage|-2.3|||||TWO_SIDED|95.0|-8.3|3.8||||||Imputing within +28d DNA for wk52: d/c for non response \<28 days from Wk 52:Treating missing as failure for patients who discontinued prior to Week 52 due to unsatisfactory therapeutic effect and imputing missing with the earliest available assessment within the 28-day window starting from the scheduled Week 52 date for other patients (if no such assessment is available, treated as failure)||3.8|-8.3|
70852313|NCT01457352|141193207|SUPERIORITY|||||||0.2062|||||||Cochran-Mantel-Haenszel|||||||0.2062
70852314|NCT01457352|141193208|SUPERIORITY|||||||0.0485|||||||Mantel Haenszel|||||||0.0485
70852315|NCT04174365|141193215|SUPERIORITY||Least squares (LS) mean difference|-1.22||||0.4597|TWO_SIDED|95.0|-4.49|2.05|||Mixed model repeated measures(MMRM)|MMRM method with model terms: treatment, trial site, baseline body weight stratum, visit, treatment-by-visit and baseline-by-visit interaction.|MMRM method with model terms: treatment, trial site, baseline body weight stratum, visit, treatment-by-visit and baseline-by-visit interaction. Significance test was based on least-square means using a two-sided 0.05 level.|||2.05|-4.49|0.4597
70936488|NCT01263496|141373317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.511|||||TWO_SIDED|95.0|0.236|0.786||||||||0.786|0.236|
70936489|NCT01263496|141373317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.437|||||TWO_SIDED|95.0|0.19|0.685||||||||0.685|0.190|
70936490|NCT01263496|141373317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.718|||||TWO_SIDED|95.0|0.413|1.022||||||||1.022|0.413|
71060443|NCT04886596|141628339|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|78.75|||||TWO_SIDED|95.0|57.95|89.26|||Regression, Cox||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Piecewise Cox model with time-varying efficacy - adjusted by age and region).|To evaluate the evolution of efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 1.||89.26|57.95|
71060444|NCT04886596|141628339|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|67.63|||||TWO_SIDED|95.0|52.47|77.95|||Regression, Cox||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Piecewise Cox model with time-varying efficacy - adjusted by age and region).|To evaluate the evolution of efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 2, following a single dose of the RSVPreF3 OA investigational vaccine.||77.95|52.47|
71060445|NCT04886596|141628339|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|62.87|||||TWO_SIDED|95.0|46.76|74.11|||Regression, Cox||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Piecewise Cox model with time-varying efficacy - adjusted by age and region).|To evaluate the evolution of efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 3, following a single dose of the RSVPreF3 OA investigational vaccine.||74.11|46.76|
71060446|NCT04886596|141628339|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|67.49|||||TWO_SIDED|95.0|52.27|77.86|||Regression, Cox||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Piecewise Cox model with time-varying efficacy - adjusted by age and region).|To evaluate the evolution of efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 2, following annual revaccination of the RSVPreF3 OA investigational vaccine.||77.86|52.27|
70852316|NCT04174365|141193216|SUPERIORITY||LS mean difference|-0.07||||0.7315|TWO_SIDED|95.0|-0.46|0.32|||MMRM|MMRM method with model terms: treatment, trial site, baseline body weight stratum, visit, treatment-by-visit and baseline-by-visit interaction.|MMRM method with model terms: treatment, trial site, baseline body weight stratum, visit, treatment-by-visit and baseline-by-visit interaction. Significance test was based on least-square means using a two-sided 0.05 level.|||0.32|-0.46|0.7315
71060447|NCT04886596|141628339|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|67.66|||||TWO_SIDED|95.0|51.71|78.34|||Regression, Cox||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Piecewise Cox model with time-varying efficacy - adjusted by age and region).|To evaluate the evolution of efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 3, following annual revaccination of the RSVPreF3 OA investigational vaccine.||78.34|51.71|
70852317|NCT00109590|141193246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was two-sided P\<0.05.|wilcoxon Signed Rank Test|||The null hypothesis was that there was no difference in within-subject Cpredose LPV/r plasma drug concentrations within 72 hours after delivery versus at 30 days postpartum.||||0.009
71060448|NCT04886596|141628340|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|66.49|||||TWO_SIDED|95.0|47.54|79.4|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA by baseline comorbidities with low/medium risk (Charlson Comorbidity Index), following a single dose of the RSVPreF3 OA investigational vaccine.||79.40|47.54|
71060449|NCT04886596|141628340|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|58.88|||||TWO_SIDED|95.0|34.81|74.98|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA by baseline comorbidities with high risk (Charlson Comorbidity Index), following a single dose of the RSVPreF3 OA investigational vaccine.||74.98|34.81|
71060450|NCT04886596|141628340|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|72.55|||||TWO_SIDED|95.0|54.34|84.37|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA by baseline comorbidities with low/medium risk (Charlson Comorbidity Index), following annual revaccination of the RSVPreF3 OA investigational vaccine.||84.37|54.34|
70852318|NCT00109590|141193246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.048||95.0||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was two-sided P\<0.05.|Wilcoxon Signed Rank Test|||The null hypothesis was that there was no difference in within-subject C4hour LPV/r plasma drug concentrations within 72 hours after delivery versus at 30 days postpartum||||0.048
70936491|NCT01263496|141373318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|||||TWO_SIDED|95.0|-0.029|0.481||||||||0.481|-0.029|
70936492|NCT01263496|141373318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.358|||||TWO_SIDED|95.0|0.104|0.612||||||||0.612|0.104|
70936493|NCT01263496|141373318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.308|||||TWO_SIDED|95.0|0.076|0.54||||||||0.540|0.076|
70936494|NCT01263496|141373318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.331|||||TWO_SIDED|95.0|0.098|0.565||||||||0.565|0.098|
70936495|NCT01263496|141373319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-0.13|0.41||||||||0.410|-0.130|
70936496|NCT01263496|141373319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.245|||||TWO_SIDED|95.0|-0.026|0.516||||||||0.516|-0.026|
70936497|NCT01263496|141373319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.294|||||TWO_SIDED|95.0|0.035|0.552||||||||0.552|0.035|
70936498|NCT01263496|141373319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.329|||||TWO_SIDED|95.0|0.032|0.626||||||||0.626|0.032|
70936499|NCT01263496|141373320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.049|||||TWO_SIDED|95.0|-0.252|0.349||||||||0.349|-0.252|
71109738|NCT00980148|141724536|NON_INFERIORITY_OR_EQUIVALENCE|This noninferiority study tested the null hypothesis that the failure rate of azithromycin is 5% higher than that of doxycycline against the alternative hypothesis that there is no difference between the two treatments. The treatment failure rate was assumed to be 3% for both treatments. To test this hypothesis at the one-sided 0.10 significance level with power of 0.90 required 153 study subjects per arm in the per-protocol population.|Risk Difference (RD)|3.2|||||ONE_SIDED|90.0||5.9|||||The risk difference is the percentage in the azithromycin arm with treatment failure minus the percentage in the doxycycline arm with treatment failure. Noninferiority of azithromycin would be supported if the upper 90% confidence limit is below 5%.|This noninferiority study tested the null hypothesis that the failure rate of azithromycin is 5% higher than that of doxycycline against the alternative hypothesis that there is no difference between the two treatments. The one-sided 90% exact confidence interval was used to estimate the difference between the two failures rates.||5.9||
71060451|NCT04886596|141628340|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|61.99|||||TWO_SIDED|95.0|37.17|78.01|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA by baseline comorbidities with high risk (Charlson Comorbidity Index), following annual revaccination of the RSVPreF3 OA investigational vaccine.||78.01|37.17|
71060452|NCT04886596|141628341|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|61.48|||||TWO_SIDED|95.0|38.62|76.74|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with no pre-existing comorbidity of interest, following a single dose of the RSVPreF3 OA investigational vaccine.||76.74|38.62|
70936500|NCT01263496|141373320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42|||||TWO_SIDED|95.0|0.138|0.703||||||||0.703|0.138|
70936501|NCT01263496|141373320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46|||||TWO_SIDED|95.0|0.178|0.742||||||||0.742|0.178|
70936502|NCT01263496|141373320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.384|||||TWO_SIDED|95.0|0.085|0.683||||||||0.683|0.085|
70936503|NCT01263496|141373321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|||||TWO_SIDED|95.0|-0.257|0.326||||||||0.326|-0.257|
70936504|NCT01263496|141373321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.249|||||TWO_SIDED|95.0|-0.043|0.542||||||||0.542|-0.043|
70936505|NCT01263496|141373321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|||||TWO_SIDED|95.0|-0.196|0.417||||||||0.417|-0.196|
70936506|NCT01263496|141373321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.333|||||TWO_SIDED|95.0|0.01|0.656||||||||0.656|0.010|
70936507|NCT01263496|141373322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.268|||||TWO_SIDED|95.0|-0.769|0.233||||||||0.233|-0.769|
70936508|NCT01263496|141373322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.349|||||TWO_SIDED|95.0|-0.156|0.855||||||||0.855|-0.156|
70936509|NCT01263496|141373322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-0.297|0.577||||||||0.577|-0.297|
70936510|NCT01263496|141373322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.308|||||TWO_SIDED|95.0|-0.075|0.69||||||||0.690|-0.075|
70936511|NCT01263496|141373323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.281|||||TWO_SIDED|95.0|-0.367|0.928||||||||0.928|-0.367|
70936512|NCT01263496|141373323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.579|||||TWO_SIDED|95.0|-0.035|1.194||||||||1.194|-0.035|
70936513|NCT01263496|141373323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.647|||||TWO_SIDED|95.0|0.054|1.241||||||||1.241|0.054|
70936514|NCT01263496|141373323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.252|||||TWO_SIDED|95.0|-0.28|0.785||||||||0.785|-0.280|
70936515|NCT01263496|141373324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-1.246|0.646||||||||0.646|-1.246|
70936516|NCT01263496|141373324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.643|||||TWO_SIDED|95.0|-0.305|1.591||||||||1.591|-0.305|
70936517|NCT01263496|141373324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|||||TWO_SIDED|95.0|-0.599|0.888||||||||0.888|-0.599|
70936518|NCT01263496|141373324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||||TWO_SIDED|95.0|-0.673|1.173||||||||1.173|-0.673|
70936519|NCT01263496|141373325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|||||TWO_SIDED|95.0|-4.462|2.562||||||||2.562|-4.462|
70936520|NCT01263496|141373325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|||||TWO_SIDED|95.0|-2.712|2.779||||||||2.779|-2.712|
70936521|NCT01263496|141373325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-3.273|2.073||||||||2.073|-3.273|
70936522|NCT01263496|141373325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.874|2.074||||||||2.074|-2.874|
70936523|NCT01263496|141373326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|||||TWO_SIDED|95.0|-0.14|0.458||||||||0.458|-0.140|
70936524|NCT01263496|141373326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|||||TWO_SIDED|95.0|-0.001|0.52||||||||0.520|-0.001|
71109739|NCT01747915|141724544|SUPERIORITY||Least Square (LS) Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.088||0.8121|TWO_SIDED|95.0|-0.15|0.19|||ANCOVA|||Estimates and p-values from an ANCOVA model including fixed effects for log transformed baseline value, region, age strata, and treatment group.||0.19|-0.15|0.8121
71109740|NCT01747915|141724544|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.088||0.8889|TWO_SIDED|95.0|-0.19|0.16|||ANCOVA|||Estimates and p-values from an ANCOVA model including fixed effects for log transformed baseline value, region, age strata, and treatment group.||0.16|-0.19|0.8889
71109741|NCT01747915|141724545|SUPERIORITY||Odds Ratio (OR)|1.095||||0.7973|TWO_SIDED|95.0|0.548|2.186||P-values were from a Logistic Regression Model including fixed effects for region, age strata and treatment.|Regression, Logistic|||||2.186|0.548|0.7973
71109742|NCT01747915|141724545|SUPERIORITY||Odds Ratio (OR)|0.934||||0.8474|TWO_SIDED|95.0|0.465|1.877||P-values were from a Logistic Regression Model including fixed effects for region, age strata and treatment.|Regression, Logistic|||||1.877|0.465|0.8474
71109743|NCT00887159|141724555|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98||||0.45|TWO_SIDED|95.0|0.65|1.47||P-value is one-sided.|Regression, Cox||The hazard ratio was derived comparing Arm B to Arm A.|There are 2 primary comparisons and each involves comparing the experimental arms (B, C) to the control arm (A). Accrual goal was 54 patients per arm. With a 1-sided 0.1 level logrank test for each test, we have 90% power to detect a 42% reduction in the PFS hazard rate of 0.139 to 0.082 (corresponding to an improvement in median PFS of 5 months to 8.5 months) with 18-month accrual and 12-month follow-up; assuming exponential survival. For each test, 94 events are needed to achieve this power.||1.47|0.65|0.45
71109744|NCT00887159|141724555|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99||||0.48|TWO_SIDED|95.0|0.66|1.48||P-value is one-sided.|Regression, Cox||Hazard ratio was derived comparing Arm C to Arm A.|There are 2 primary comparisons and each involves comparing the experimental arms (B, C) to the control arm (A). Accrual goal was 54 patients per arm. With a 1-sided 0.1 level logrank test for each test, we have 90% power to detect a 42% reduction in the PFS hazard rate of 0.139 to 0.082 (corresponding to an improvement in median PFS of 5 months to 8.5 months) with 18-month accrual and 12-month follow-up; assuming exponential survival. For each test, 94 events are needed to achieve this power.||1.48|0.66|0.48
71109745|NCT00887159|141724558|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.69||||0.01|TWO_SIDED|95.0|1.13|2.52|||Regression, Cox||Hazard ratio was derived comparing the high CTCs group to the low CTCs group.|||2.52|1.13|0.01
71109746|NCT03420742|141724568|OTHER||Geometric least squares mean ratio|0.741|||||TWO_SIDED|90.0|0.6|0.915|||||The ratios of geometric mean were calculated on the basis of the within-participant variance. Participant was treated as a random effect in the model.|||0.915|0.600|
71109747|NCT03420742|141724569|OTHER||Geometric least squares mean ratio|0.836|||||TWO_SIDED|90.0|0.662|1.06|||||The ratios of geometric mean were calculated on the basis of the within-participant variance. Participant was treated as a random effect in the model.|||1.06|0.662|
71109748|NCT01119443|141724588|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|104.2|||||TWO_SIDED|90.0|98.3|110.3|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||110.3|98.3|
71109749|NCT01119443|141724589|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|104.8||||||90.0|100.1|109.8|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||109.8|100.1|
71109750|NCT01119443|141724590|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|108.31|||||TWO_SIDED|90.0|95.634|122.676|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||122.676|95.634|
71109751|NCT01119443|141724591|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|106.85|||||TWO_SIDED|90.0|93.189|122.251|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||122.251|93.189|
71109752|NCT01119443|141724592|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|98.426|||||TWO_SIDED|90.0|84.276|112.58|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||112.58|84.276|
71109753|NCT01119443|141724593|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|95.11|||||TWO_SIDED|90.0|82.461|109.698|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||109.698|82.461|
70936525|NCT01263496|141373326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|||||TWO_SIDED|95.0|-0.126|0.398||||||||0.398|-0.126|
70936526|NCT01263496|141373326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.298|||||TWO_SIDED|95.0|0.042|0.553||||||||0.553|0.042|
70936527|NCT01263496|141373327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.92|||||TWO_SIDED|95.0|-11.82|7.99||||||||7.99|-11.82|
71060453|NCT04886596|141628341|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|64.73|||||TWO_SIDED|95.0|45.1|78.14|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing comorbidity of interest, following a single dose of the RSVPreF3 OA investigational vaccine.||78.14|45.10|
71060454|NCT04886596|141628341|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|68.14|||||TWO_SIDED|95.0|45.71|82.33|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing cardiorespiratory condition, following a single dose of the RSVPreF3 OA investigational vaccine.||82.33|45.71|
71060455|NCT04886596|141628341|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|63.88|||||TWO_SIDED|95.0|31.35|82.48|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing endocrinometabolic condition, following a single dose of the RSVPreF3 OA investigational vaccine.||82.48|31.35|
71060456|NCT04886596|141628341|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|64.16|||||TWO_SIDED|95.0|41.08|79.17|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with no pre-existing comorbidity of interest, following annual revaccination of the RSVPreF3 OA investigational vaccine.||79.17|41.08|
71060457|NCT04886596|141628341|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|71.19|||||TWO_SIDED|95.0|51.92|83.65|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing comorbidity of interest, following annual revaccination of the RSVPreF3 OA investigational vaccine.||83.65|51.92|
70936528|NCT01263496|141373327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.02|||||TWO_SIDED|95.0|-12.45|6.4||||||||6.40|-12.45|
70936529|NCT01263496|141373327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.41|||||TWO_SIDED|95.0|-18.77|1.96||||||||1.96|-18.77|
70936530|NCT01263496|141373327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.96|||||TWO_SIDED|95.0|-18.35|0.44||||||||0.44|-18.35|
70936531|NCT01263496|141373328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.66|||||TWO_SIDED|95.0|-3.88|19.19||||||||19.19|-3.88|
70936532|NCT01263496|141373328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|||||TWO_SIDED|95.0|-11.41|9.24||||||||9.24|-11.41|
70936533|NCT01263496|141373328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|||||TWO_SIDED|95.0|-12.91|10.75||||||||10.75|-12.91|
70936534|NCT01263496|141373328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-11.32|9.99||||||||9.99|-11.32|
70936535|NCT01263496|141373329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|||||TWO_SIDED|95.0|-7.09|16.49||||||||16.49|-7.09|
70936536|NCT01263496|141373329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63|||||TWO_SIDED|95.0|-8.63|11.89||||||||11.89|-8.63|
70936537|NCT01263496|141373329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.69|||||TWO_SIDED|95.0|-13.36|7.98||||||||7.98|-13.36|
70936538|NCT01263496|141373329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2|||||TWO_SIDED|95.0|-20.58|2.17||||||||2.17|-20.58|
70936539|NCT01263496|141373330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-11.44|9.84||||||||9.84|-11.44|
70936540|NCT01263496|141373330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04|||||TWO_SIDED|95.0|-11.74|7.66||||||||7.66|-11.74|
70936541|NCT01263496|141373330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.44|||||TWO_SIDED|95.0|-15.62|4.75||||||||4.75|-15.62|
71060458|NCT04886596|141628341|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|75.94|||||TWO_SIDED|95.0|54.11|88.54|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing cardiorespiratory condition,following annual revaccination of the RSVPreF3 OA investigational vaccine.||88.54|54.11|
71060459|NCT04886596|141628341|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|69.85|||||TWO_SIDED|95.0|37.51|87.05|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing endocrinometabolic condition, following annual revaccination of the RSVPreF3 OA investigational vaccine.||87.05|37.51|
71060460|NCT04886596|141628342|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|-153.57|||||TWO_SIDED|95.0|-16322.97|88.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (frail) in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||88.00|-16322.97|
71060461|NCT04886596|141628342|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|70.07|||||TWO_SIDED|95.0|43.89|85.33|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (pre-frail) in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||85.33|43.89|
71060462|NCT04886596|141628342|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|61.04|||||TWO_SIDED|95.0|42.89|74.08|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (fit) in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||74.08|42.89|
71060463|NCT04886596|141628342|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|13.62|||||TWO_SIDED|95.0|-6751.38|98.91|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (frail) in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||98.91|-6751.38|
71060464|NCT04886596|141628342|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|74.32|||||TWO_SIDED|95.0|49.33|88.31|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (pre-frail) in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||88.31|49.33|
71109754|NCT01119443|141724595|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|104.07|||||TWO_SIDED|90.0|91.585|118.263|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||118.263|91.585|
71109755|NCT01119443|141724596|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|93.6||||||90.0|86.9|100.8|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||100.8|86.9|
70936542|NCT01263496|141373330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.28|||||TWO_SIDED|95.0|-23.83|-2.74||||||||-2.74|-23.83|
70936543|NCT01263496|141373331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.02|||||TWO_SIDED|95.0|-28.15|14.1||||||||14.10|-28.15|
70936544|NCT01263496|141373331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.45|||||TWO_SIDED|95.0|-23.93|13.02||||||||13.02|-23.93|
70936545|NCT01263496|141373331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.8|||||TWO_SIDED|95.0|-35.46|-0.13||||||||-0.13|-35.46|
70936546|NCT01263496|141373331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.58|||||TWO_SIDED|95.0|-47.75|-13.41||||||||-13.41|-47.75|
70936547|NCT01263496|141373332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.45|||||TWO_SIDED|95.0|-5.18|42.09||||||||42.09|-5.18|
70936548|NCT01263496|141373332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.86|||||TWO_SIDED|95.0|-13.56|33.28||||||||33.28|-13.56|
71060465|NCT04886596|141628342|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|64.79|||||TWO_SIDED|95.0|46.1|77.75|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (fit) in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||77.75|46.10|
71060466|NCT04886596|141628343|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|67.38|||||TWO_SIDED|95.0|42.43|82.68|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to any case definition, following a single dose of the RSVPreF3 OA investigational vaccine.||82.68|42.43|
71060467|NCT04886596|141628343|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|67.38|||||TWO_SIDED|95.0|42.43|82.68|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to case definition 1, following a single dose of the RSVPreF3 OA investigational vaccine.||82.68|42.43|
71060468|NCT04886596|141628343|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|59.16|||||TWO_SIDED|95.0|-119.6|95.93|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to the case definition 2, following a single dose of the RSVPreF3 OA investigational vaccine.||95.93|-119.60|
71060469|NCT04886596|141628343|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|78.8|||||TWO_SIDED|95.0|57.05|90.75|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to any case definition, following annual revaccination of the RSVPreF3 OA investigational vaccine.||90.75|57.05|
71060470|NCT04886596|141628343|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|78.8|||||TWO_SIDED|95.0|57.05|90.75|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to case definition 1, following annual revaccination of the RSVPreF3 OA investigational vaccine.||90.75|57.05|
71060471|NCT04886596|141628343|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|100.0|||||TWO_SIDED|95.0|20.27|100.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to case definition 2, following annual revaccination of the RSVPreF3 OA investigational vaccine.||100.00|20.27|
71060472|NCT04886596|141628344|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|51.13|||||TWO_SIDED|95.0|40.31|60.21|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed ARI in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||60.21|40.31|
71060473|NCT04886596|141628344|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|58.44|||||TWO_SIDED|95.0|48.1|66.96|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed ARI in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||66.96|48.10|
71109756|NCT01119443|141724597|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|100.2|||||TWO_SIDED|90.0|94.0|106.7|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||106.7|94.0|
71109757|NCT01119443|141724598|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|86.57|||||TWO_SIDED|90.0|73.583|101.854|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.854|73.583|
71109758|NCT01119443|141724599|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|86.57|||||TWO_SIDED|90.0|73.583|101.854|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.854|73.583|
71109759|NCT01119443|141724600|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|99.069|||||TWO_SIDED|90.0|80.688|117.45|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||117.45|80.688|
71109760|NCT01119443|141724601|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|109.48|||||TWO_SIDED|90.0|89.571|133.811|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||133.811|89.571|
71109761|NCT01119443|141724603|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|92.63|||||TWO_SIDED|90.0|77.871|110.185|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||110.185|77.871|
71109762|NCT00775268|141724604|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed-rank test|||||||<0.001
71109763|NCT00775268|141724605|SUPERIORITY|||||||0.0313|||||||Wilcoxon matched-pairs signed rank test|||||||0.0313
71109764|NCT01194245|141724621|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be supported if the upper limit of the two-sided 95% confidence interval for the difference between Analog-PH20 and the comparator (insulin lispro) did not exceed 0.40.|LS Means Difference|0.05||||0.2878|TWO_SIDED|95.0|-0.05|0.15|||Mixed Models Analysis|||Approximately 110 participants were to be enrolled, allowing approximately 88 participants to complete both treatment periods (44 for each investigational drug). Assuming a dropout rate of no more than 20%, intra-participant correlation of 0.80, standard deviation of 1.2, and a true difference of 0, the study would have a greater than 90% power to show that Analog-PH20 was non-inferior to insulin lispro alone with respect to the change from baseline in A1C at the end of each treatment period.||0.15|-0.05|0.2878
70852319|NCT00353470|141193256|SUPERIORITY||shared parameters model|-0.56|STANDARD_ERROR_OF_MEAN|0.29|>|0.16|TWO_SIDED||||||Chi-squared|||Power: to detect a between-group effect size of 0.45, for statistical power of 0.80, 56 patients for PFPP or CBT vs. 28 for ART were required. Response rates at termination were calculated by chi-square in the full ITT sample using LOCF.||||>0.16
70852320|NCT00353470|141193256|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
70852321|NCT00966875|141193421|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||A log transformed dose was used in the model.|Regression, Logistic|||||||0.031
70852322|NCT00966875|141193422|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||Fisher Exact|||||||0.033
71109765|NCT05069649|141724649|SUPERIORITY|||||||0.0046|||||||Chi-squared|||||||0.0046
71109766|NCT05069649|141724650|SUPERIORITY|||||||0.2488|||||||Fisher Exact|||||||0.2488
71109767|NCT05069649|141724651|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71109768|NCT05069649|141724652|SUPERIORITY|||||||0.32|||||||Fisher Exact|||||||0.32
71109769|NCT05069649|141724653|SUPERIORITY|||||||0.02|||||||Fisher Exact|||||||0.02
71109770|NCT05069649|141724654|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
71109771|NCT00461708|141724673|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
71109772|NCT00461708|141724674|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
71109773|NCT03800030|141724678|SUPERIORITY|||||||0.031|||||||t-test, 2 sided|degrees of freedom = 22 t-statistic = 2.305||||||0.031
71109774|NCT03800030|141724679|SUPERIORITY|||||||0.935|||||||t-test, 2 sided|degrees of freedom = 22 t-statistic = 0.083||||||0.935
71109775|NCT03800030|141724680|SUPERIORITY|||||||0.04|||||||t-test, 1 sided|degrees of freedom = 22 t-statistic = 1.833||||||0.040
71109776|NCT03800030|141724681|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|degrees of freedom = 22 t-statistic = 2.174||||||0.020
71109777|NCT03800030|141724682|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|degrees of freedom = 22 t-statistic = -0.623||||||0.540
71109778|NCT03800030|141724683|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|degrees of freedom = 22 t-statistic = 2.989||||||0.007
71109779|NCT02230189|141724684|SUPERIORITY||Mean Difference (Net)|2.11||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR4521||||0.010
71109780|NCT02230189|141724684|SUPERIORITY||Mean Difference (Net)|0.56||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR107||||0.010
71109781|NCT02230189|141724684|SUPERIORITY||Mean Difference (Net)|2.57||||0.018|TWO_SIDED||||||t-test, 2 sided|||miR-891a||||0.018
71109782|NCT02230189|141724684|SUPERIORITY||Mean Difference (Net)|0.88||||0.021|TWO_SIDED||||||t-test, 2 sided|||miR363||||0.021
71109783|NCT02230189|141724684|SUPERIORITY||Mean Difference (Net)|-1.0||||0.028|TWO_SIDED||||||t-test, 2 sided|||miR1248||||0.028
71109784|NCT02230189|141724684|SUPERIORITY||Mean Difference (Net)|-0.85||||0.033|TWO_SIDED||||||t-test, 2 sided|||miR944||||0.033
71109785|NCT02230189|141724684|SUPERIORITY||Mean Difference (Net)|2.13||||0.034|TWO_SIDED||||||t-test, 2 sided|||miR6806||||0.034
71109786|NCT02230189|141724684|SUPERIORITY||Mean Difference (Net)|0.39||||0.036|TWO_SIDED||||||t-test, 2 sided|||miR103a||||0.036
71109787|NCT02230189|141724684|SUPERIORITY||Mean Difference (Net)|1.69||||0.037|TWO_SIDED||||||t-test, 2 sided|||miR454||||0.037
71109788|NCT02230189|141724684|SUPERIORITY||Mean Difference (Net)|-1.13||||0.041|TWO_SIDED||||||t-test, 2 sided|||miR320e||||0.041
71109789|NCT02230189|141724684|SUPERIORITY||Mean Difference (Net)|-0.55||||0.043|TWO_SIDED||||||t-test, 2 sided|||miR181a||||0.043
71109790|NCT02230189|141724684|SUPERIORITY||Mean Difference (Net)|1.95||||0.044|TWO_SIDED||||||t-test, 2 sided|||miR130b||||0.044
71109791|NCT02230189|141724684|SUPERIORITY||Mean Difference (Net)|-2.18||||0.044|TWO_SIDED||||||t-test, 2 sided|||miR365a||||0.044
70936549|NCT01263496|141373332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.44|||||TWO_SIDED|95.0|-30.25|15.37||||||||15.37|-30.25|
71060474|NCT04886596|141628345|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|2.33|||||TWO_SIDED|95.0|-1.47|5.99|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of any ARI in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||5.99|-1.47|
71060475|NCT04886596|141628345|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|3.32|||||TWO_SIDED|95.0|-0.5|6.98|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of any ARI in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||6.98|-0.50|
70936550|NCT01263496|141373332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.8|||||TWO_SIDED|95.0|-34.75|9.15||||||||9.15|-34.75|
70936551|NCT01263496|141373333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.84|||||TWO_SIDED|95.0|-13.9|25.58||||||||25.58|-13.90|
70936552|NCT01263496|141373333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.35|||||TWO_SIDED|95.0|-18.2|24.9||||||||24.90|-18.20|
70936553|NCT01263496|141373333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.64|||||TWO_SIDED|95.0|-26.03|18.74||||||||18.74|-26.03|
71109792|NCT02230189|141724684|SUPERIORITY||Mean Difference (Net)|2.06||||0.047|TWO_SIDED||||||t-test, 2 sided|||miR135b||||0.047
71109793|NCT02230189|141724684|SUPERIORITY||Mean Difference (Net)|-2.35||||0.048|TWO_SIDED||||||t-test, 2 sided|||miR1273h||||0.048
71109794|NCT02230189|141724684|SUPERIORITY||Mean Difference (Net)|-1.31||||0.048|TWO_SIDED||||||t-test, 2 sided|||miR3177||||0.048
71109795|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|-1.83||||0|TWO_SIDED||||||t-test, 2 sided|||miR6510||||0.0
71109796|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|-2.09||||0|TWO_SIDED||||||t-test, 2 sided|||miR3605||||0
71109797|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|-5.75||||0|TWO_SIDED||||||t-test, 2 sided|||miR3912||||0
71109798|NCT02230189|141724685|SUPERIORITY||Median Difference (Net)|1.93||||0|TWO_SIDED||||||t-test, 2 sided|||miR15b||||0
71109799|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|-2.35||||0|TWO_SIDED||||||t-test, 2 sided|||miR127||||0
71109800|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|1.59||||0|TWO_SIDED||||||t-test, 2 sided|||miR146a||||0
71109801|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|1.21||||0|TWO_SIDED||||||t-test, 2 sided|||miR449b||||0
71109802|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|0.85||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR21-5p||||0.01
71109803|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|-1.29||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR6842||||0.01
71109804|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|1.24||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR142-5p||||0.01
71109805|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|1.67||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR21||||0.01
71109806|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|-4.24||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR493||||0.01
71109807|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|-1.46||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR193a||||0.01
71109808|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|-0.89||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR149||||0.01
71109809|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|1.06||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR449a||||0.01
71109810|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|-2.1||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR6511a||||0.01
71109811|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|-1.59||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR6843||||0.01
71109812|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|-0.95||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR671||||0.01
71109813|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|-4.65||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR6503||||0.02
71109814|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|2.84||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR450b||||0.02
71109815|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|-4.92||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR485||||0.02
71109816|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|-2.49||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR6806||||0.02
71109817|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|2.18||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR3182||||0.02
71109818|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|1.28||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR142-3p||||0.02
71109819|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|-1.23||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR320d||||0.02
71109820|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|2.73||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR3928||||0.02
71109821|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|4.59||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR744||||0.02
71109822|NCT02230189|141724685|SUPERIORITY||Median Difference (Net)|3.42||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR206||||0.02
71109823|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|0.9||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR30e||||0.03
71109824|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|1.52||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR4500||||0.03
71109825|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|-0.98||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR125a||||0.03
71109826|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|-0.6||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR99b||||0.03
71109827|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|2.67||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR1||||0.03
71109828|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|-0.77||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR146b||||0.03
71109829|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|-3.17||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR1255a||||0.03
71109830|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|1.02||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR223||||0.03
71060476|NCT04886596|141628345|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|3.68|||||TWO_SIDED|95.0|-1.55|8.63|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of any LRTD in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||8.63|-1.55|
71060477|NCT04886596|141628345|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|6.99|||||TWO_SIDED|95.0|1.81|11.9|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of any LRTD in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||11.90|1.81|
71060478|NCT04886596|141628346|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|50.37|||||TWO_SIDED|95.0|-184.45|95.19|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||95.19|-184.45|
71060479|NCT04886596|141628346|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|50.37|||||TWO_SIDED|95.0|-184.45|95.19|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease or complication related to RT-PCR-confirmed RSV ARI during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||95.19|-184.45|
71060480|NCT04886596|141628346|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|100.0|||||TWO_SIDED|95.0|11.56|100.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||100.00|11.56|
71060481|NCT04886596|141628346|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|100.0|||||TWO_SIDED|95.0|11.56|100.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease or complication related to RT-PCR-confirmed RSV ARI during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||100.00|11.56|
71060482|NCT04886596|141628346|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|22.14|||||TWO_SIDED|95.0|-457.67|93.12|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease during the RSV seson in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||93.12|-457.67|
71060483|NCT04886596|141628346|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|22.14|||||TWO_SIDED|95.0|-457.67|93.12|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease or complication related to RT-PCR-confirmed RSV ARI during the RSV season in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||93.12|-457.67|
71109831|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|-0.78||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR642a||||0.03
71109832|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|2.17||||0.4|TWO_SIDED||||||t-test, 2 sided|||miR548ae||||0.4
70852323|NCT00966875|141193422|SUPERIORITY_OR_OTHER|||||||0.047|||||||Fisher Exact|||||||0.047
71109833|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|-0.79||||0.04|TWO_SIDED||||||t-test, 2 sided|||miR146b||||0.04
71109834|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|-2.52||||0.04|TWO_SIDED||||||t-test, 2 sided|||miR877||||0.04
71109835|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|-0.69||||0.04|TWO_SIDED||||||t-test, 2 sided|||miR181a||||0.04
71109836|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|-3.4||||0.04|TWO_SIDED||||||t-test, 2 sided|||miR4467||||0.04
71109837|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|-2.48||||0.04|TWO_SIDED||||||t-test, 2 sided|||miR1249||||0.04
71109838|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|3.87||||0.04|TWO_SIDED||||||t-test, 2 sided|||miR766||||0.04
71109839|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|1.07||||0.048|TWO_SIDED||||||t-test, 2 sided|||miR29c||||0.048
71109840|NCT02230189|141724685|SUPERIORITY||Mean Difference (Net)|-1.75||||-1.75|TWO_SIDED||||||t-test, 2 sided|||miR370||||-1.75
70936554|NCT01263496|141373333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.37|||||TWO_SIDED|95.0|-47.08|0.34||||||||0.34|-47.08|
70936555|NCT01263496|141373334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.97|||||TWO_SIDED|95.0|-18.77|24.71||||||||24.71|-18.77|
70936556|NCT01263496|141373334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.37|||||TWO_SIDED|95.0|-21.21|23.94||||||||23.94|-21.21|
71060484|NCT04886596|141628346|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|100.0|||||TWO_SIDED|95.0|-54.53|100.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease during the RSV season in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||100.00|-54.53|
71060485|NCT04886596|141628346|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|100.0|||||TWO_SIDED|95.0|-54.53|100.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease or complication related to RT-PCR-confirmed RSV ARI during the RSV season in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||100.00|-54.53|
71060486|NCT04886596|141628347|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|-1.81|||||TWO_SIDED|95.0|-25.43|17.49|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||17.49|-25.43|
71109841|NCT01074125|141724686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3376|||<|0.0001|TWO_SIDED||||||Regression, Linear|||To assess dose ranging, the primary efficacy variable will be analyzed via a model with dose effect. Positive dose ranging confirmed if the null hypothesis of slope =0 was rejected at a significance level of 0.05||||<0.0001
70852324|NCT00966875|141193426|SUPERIORITY_OR_OTHER|||||||0.013||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.013
70936557|NCT01263496|141373334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.2|||||TWO_SIDED|95.0|-32.69|10.3||||||||10.30|-32.69|
70936558|NCT01263496|141373334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-34.9|||||TWO_SIDED|95.0|-56.85|-12.96||||||||-12.96|-56.85|
70936559|NCT01263496|141373335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.955|||||TWO_SIDED|95.0|0.375|1.535||||||||1.535|0.375|
70936560|NCT01263496|141373335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.358|||||TWO_SIDED|95.0|0.752|1.965||||||||1.965|0.752|
70936561|NCT01263496|141373335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.35|||||TWO_SIDED|95.0|0.724|1.975||||||||1.975|0.724|
70936562|NCT01263496|141373335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.38|||||TWO_SIDED|95.0|0.804|1.955||||||||1.955|0.804|
71109842|NCT00527618|141724728|SUPERIORITY_OR_OTHER||Slope|-0.27|||<|0.001|TWO_SIDED|95.0|-0.41|-0.14|||Mixed Models Analysis|Adjusted for baseline plasma HIV-1 RNA.|Acyclovir was coded as 0 and valacyclovir as 1. The beta-coefficient (slope) indicates the average difference in HIV-1 RNA on valacyclovir and acyclovir; a negative number indicates that plasma HIV-1 RNA was lower on valacyclovir than acyclovir.|We estimated that a sample size of 29 participants, with 4 weeks of weekly plasma HIV-1 RNA levels per treatment arm, would be required to detect a 0.25 log10 copies/ml difference in plasma HIV-1 RNA between the study arms with 80% power, at a two-sided type I error rate of 5%.||-0.14|-0.41|<0.001
71109843|NCT00527618|141724729|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.95||||0.78|TWO_SIDED|95.0|0.66|1.37|||Random effects poission regression|Adjusted for age.||We estimated that 26 participants would be required to detect a 50% reduction in genital HSV shedding with 80% power, at a two-sided type I error rate of 5%.||1.37|0.66|0.78
71109844|NCT00527618|141724730|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
71109845|NCT00527618|141724731|SUPERIORITY_OR_OTHER|||||||0.67|||||||Mixed Models Analysis|||||||0.67
71109846|NCT02706925|141724734|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.2951|STANDARD_DEVIATION|0.0352|||TWO_SIDED|95.0|1.2242|1.366|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.|||1.3660|1.2242|
71109847|NCT02706925|141724734|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.088|STANDARD_DEVIATION|0.0843|||TWO_SIDED|95.0|0.9128|1.2633|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.|||1.2633|0.9128|
71109848|NCT02706925|141724734|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.1846|STANDARD_DEVIATION|0.3328|||TWO_SIDED|95.0|0.4791|1.89|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.|||1.8900|0.4791|
71109849|NCT02706925|141724735|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.2114|STANDARD_DEVIATION|0.035|||TWO_SIDED|95.0|1.1409|1.2818|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.|||1.2818|1.1409|
71109850|NCT02706925|141724735|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.0771|STANDARD_DEVIATION|0.0524|||TWO_SIDED|95.0|0.9696|1.1845|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.|||1.1845|0.9696|
71060487|NCT04886596|141628347|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|-4.72|||||TWO_SIDED|95.0|-28.26|14.61|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases or complication related to any respiratory disease during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||14.61|-28.26|
71060488|NCT04886596|141628347|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|-3.61|||||TWO_SIDED|95.0|-28.2|16.38|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine||16.38|-28.20|
71060489|NCT04886596|141628347|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|-3.59|||||TWO_SIDED|95.0|-27.55|15.98|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases or complication related to any respiratory diseases during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||15.98|-27.55|
71060490|NCT04886596|141628347|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|2.98|||||TWO_SIDED|95.0|-23.52|23.99|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases during the RSV season in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||23.99|-23.52|
71109851|NCT02706925|141724735|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.3969|STANDARD_DEVIATION|0.3965|||TWO_SIDED|95.0|0.5563|2.2375|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.|||2.2375|0.5563|
71109852|NCT00363311|141724738|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.56||||0.009||95.0|0.36|0.87||Statistical data are for Year 1.5|Log Rank|||||0.87|0.36|0.009
71109853|NCT00363311|141724738|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.61||||0.007||95.0|0.43|0.88||Statistical data are for Overall (Years 0-3)|Log Rank|||||0.88|0.43|0.007
71109854|NCT00363311|141724739|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.46||||0.13||95.0|0.16|1.31||Statistical data are for Year 1.5|Log Rank|||||1.31|0.16|0.13
71109855|NCT00363311|141724739|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.48||||0.053||95.0|0.22|1.03||Statistical data are for Overall (Years 0-3)|Log Rank|||||1.03|0.22|0.053
71109856|NCT00363311|141724740|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.59||||0.031||95.0|0.36|0.96||Statistical data are for Year 1.5|Log Rank|||||0.96|0.36|0.031
71109857|NCT00363311|141724740|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.7||||0.079||95.0|0.46|1.05||Statistical data are for Overall (Years 0-3)|Log Rank|||||1.05|0.46|0.079
71109858|NCT00363311|141724741|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Fisher Exact|||||||0.65
71109859|NCT00363311|141724742|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||Fisher Exact|||||||0.024
71109860|NCT00363311|141724749|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.20
71109861|NCT00363311|141724750|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.039
71109862|NCT00363311|141724752|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.80
71109863|NCT00363311|141724753|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Fisher Exact|||||||0.12
71109864|NCT00120627|141724771|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|F (1,144) = 4.12, p \< .05||2 group (treatment vs. control) by 2 time (pre-intervention and post-intervention) one-way ANOVA||||<0.05
71109865|NCT00120627|141724771|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Fisher Exact|||||||<0.05
71109866|NCT00120627|141724772|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS, a maximum-likelihood method based on group assignment, demographic variables and clinical variables.||||<0.05
71109867|NCT00120627|141724773|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||2 group (treatment vs control) by 2 time points (pre-intervention and post-intervention)||||<0.0001
71109868|NCT00120627|141724774|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
71109869|NCT00120627|141724774|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mediation using Sobel Test|||||||<0.001
71109870|NCT00120627|141724775|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||||||<0.01
71109871|NCT00120627|141724776|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||2 group (treatment vs control) by 2 time (pre-intervention and post-intervention) ANOVA||||< 0.05
71109872|NCT00120627|141724777|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Depression Subscale||||<0.001
71109873|NCT00120627|141724777|SUPERIORITY_OR_OTHER||||||=|0.31|TWO_SIDED||||||ANOVA|||Anxiety Subscale||||=0.31
71109874|NCT00120627|141724777|SUPERIORITY_OR_OTHER||||||=|0.44|TWO_SIDED||||||ANOVA|||Somatization Subscale||||=0.44
71109875|NCT00120627|141724778|SUPERIORITY_OR_OTHER||||||=|0.66|TWO_SIDED||||||ANOVA|||Post-hoc analysis||||=0.66
71109876|NCT00120627|141724779|SUPERIORITY_OR_OTHER||||||=|0.18|TWO_SIDED||||||ANOVA|||||||= 0.18
71109877|NCT00120627|141724780|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||||||< 0.01
70936563|NCT01263496|141373336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.034|||||TWO_SIDED|95.0|0.344|1.723||||||||1.723|0.344|
71060491|NCT04886596|141628347|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|-1.71|||||TWO_SIDED|95.0|-28.56|19.7|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases or complication related to any respiratory disease during the RSV seasons in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||19.70|-28.56|
71060492|NCT04886596|141628347|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|4.8|||||TWO_SIDED|95.0|-22.14|26.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases during the RSV seasons in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||26.00|-22.14|
71060493|NCT04886596|141628347|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|4.64|||||TWO_SIDED|95.0|-21.73|25.48|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases or complication related to any respiratory diseases during the RSV seasons in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||25.48|-21.73|
71060494|NCT04886596|141628348|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|62.94|||||TWO_SIDED|95.0|28.91|82.15|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to RSV- ARI during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||82.15|28.91|
71060495|NCT04886596|141628348|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|63.8|||||TWO_SIDED|95.0|28.5|83.2|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to RSV-ARI during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||83.20|28.50|
71060496|NCT04886596|141628348|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|65.69|||||TWO_SIDED|95.0|28.56|85.47|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to RSV- ARI during the RSV seasons in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||85.47|28.56|
71060497|NCT04886596|141628348|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|62.87|||||TWO_SIDED|95.0|21.45|84.29|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to RSV-ARI during the RSV seasons in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||84.29|21.45|
71060498|NCT04886596|141628349|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|2.59|||||TWO_SIDED|95.0|-8.29|12.42|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to any ARI during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||12.42|-8.29|
70936564|NCT01263496|141373336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.448|||||TWO_SIDED|95.0|0.78|2.115||||||||2.115|0.780|
71109878|NCT01595529|141724787|NON_INFERIORITY|The primary analysis was a non-inferiority test comparing the proportion of subjects with symptomatic UTIs at the TOC visit to evaluate whether the difference was within the 5% equivalence interval. This test was conducted by calculating the one-sided 95% upper confidence limit for the difference in symptomatic UTI (treatment failure) rate. If this limit was less than or equal to the equivalence interval (0.05), then would conclude that short course therapy is not inferior to standard therapy.|Risk Difference (RD)|0.035569|||||ONE_SIDED|95.0||0.054844||||||||0.054844||
71109879|NCT01595529|141724788|NON_INFERIORITY|The primary analysis was a non-inferiority test comparing the proportion of subjects with symptomatic UTIs at the TOC visit to evaluate whether the difference was within the 5% equivalence interval. This test was conducted by calculating the one-sided 95% upper confidence limit for the difference in symptomatic UTI (treatment failure) rate. If this limit was less than or equal to the equivalence interval (0.05), then would conclude that short course therapy is not inferior to standard therapy.|Risk Difference (RD)|0.022169|||||ONE_SIDED|95.0||0.03939||||||||0.03939||
71109880|NCT01595529|141724789|SUPERIORITY||Risk Difference (RD)|-0.00356|||||TWO_SIDED|95.0|-0.03323|0.026102||||||||0.026102|-0.03323|
71109881|NCT01595529|141724790|SUPERIORITY||Risk Difference (RD)|-0.00994|||||TWO_SIDED|95.0|-0.04012|0.020236||||||||0.020236|-0.04012|
71109882|NCT01595529|141724791|SUPERIORITY|||||||0.2282|||||||Chi-squared|||At Test of Cure Visit||||0.2282
71109883|NCT01595529|141724791|SUPERIORITY|||||||0.4876|||||||Chi-squared|||At Outcome Assessment Visit||||0.4876
71109884|NCT01595529|141724792|SUPERIORITY|||||||0.4184|||||||Chi-squared|||At Test of Cure Visit||||0.4184
71109885|NCT01595529|141724792|SUPERIORITY|||||||0.9782|||||||Chi-squared|||At Outcome Assessment Visit||||0.9782
71109886|NCT01595529|141724793|SUPERIORITY||Risk Difference (RD)|-0.05277|||||TWO_SIDED|95.0|-0.08857|-0.01698||||||||-0.01698|-0.08857|
71109887|NCT01595529|141724794|SUPERIORITY||Risk Difference (RD)|-0.05664|||||TWO_SIDED|95.0|-0.09479|-0.0185||||||||-0.01850|-0.09479|
71109888|NCT01595529|141724795|SUPERIORITY||Risk Difference (RD)|-0.03056|||||TWO_SIDED|95.0|-0.07744|0.016323||||||||0.016323|-0.07744|
71109889|NCT01595529|141724796|SUPERIORITY||Risk Difference (RD)|-0.01094|||||TWO_SIDED|95.0|-0.058|0.036117||||||||0.036117|-0.0580|
71109890|NCT01595529|141724797|SUPERIORITY||Risk Difference (RD)|-0.10373|||||TWO_SIDED|95.0|-0.14161|-0.06585||||||||-0.06585|-0.14161|
71109891|NCT01595529|141724798|SUPERIORITY||Risk Difference (RD)|-0.09198|||||TWO_SIDED|95.0|-0.13006|-0.05391||||||||-0.05391|-0.13006|
71109892|NCT00833027|141724871|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|0.85|<|0.001|ONE_SIDED|95.0|||||Student's T-test|Student's T-test for paired samples||||||<0.001
71109893|NCT00553410|141724885|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.31|TWO_SIDED|95.0|0.93|1.26|||Log Rank|||||1.26|.93|.31
71109894|NCT00553410|141724886|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.16|TWO_SIDED|95.0|0.68|1.06|||Log Rank|||||1.06|.68|.16
71109895|NCT00553410|141724887|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.25|TWO_SIDED|95.0|0.71|1.09|||Log Rank|||||1.09|.71|.25
71109896|NCT00553410|141724888|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.84|TWO_SIDED|95.0|0.81|1.18|||Log Rank|||||1.18|.81|.84
71109897|NCT04683913|141724896|OTHER||||||<|0.001|||||||ANCOVA|alpha=0.05||||||<0.001
71109898|NCT04683913|141724897|OTHER|||||||0.027||||||Week 1\&2 vs Week 3\&4|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.027
71109899|NCT04683913|141724897|OTHER|||||||1||||||Week 3\&4 vs Week 5\&6|t-test, 2 sided|||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||1.0
71109900|NCT04683913|141724897|OTHER|||||||0.078||||||Week 5\&6 vs Follow up|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.078
71109901|NCT04683913|141724897|OTHER|||||||0.015||||||Follow up vs Retention|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.015
71109902|NCT04683913|141724897|OTHER|||||||0.567||||||Week 1\&2 vs Week 5\&6|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.567
71109903|NCT04683913|141724897|OTHER|||||||0.001||||||Week 1\&2 vs Follow up|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.001
71109904|NCT04683913|141724897|OTHER|||||||1||||||Week 1\&2 vs Retention|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||1.0
71109905|NCT04683913|141724897|OTHER|||||||0.205||||||Week 3\&4 vs Follow up|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.205
70936565|NCT01263496|141373336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.243|||||TWO_SIDED|95.0|0.616|1.87||||||||1.870|0.616|
70936566|NCT01263496|141373336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.481|||||TWO_SIDED|95.0|0.827|2.136||||||||2.136|0.827|
70936567|NCT01263496|141373337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|||||TWO_SIDED|95.0|-4.088|4.188||||||||4.188|-4.088|
70936568|NCT01263496|141373337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.585|||||TWO_SIDED|95.0|-3.476|6.647||||||||6.647|-3.476|
71060499|NCT04886596|141628349|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|6.7|||||TWO_SIDED|95.0|-4.05|16.39|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to any ARI during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||16.39|-4.05|
71060500|NCT04886596|141628349|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|10.95|||||TWO_SIDED|95.0|-0.68|21.31|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to any ARI during the RSV seasons in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||21.31|-0.68|
71060501|NCT04886596|141628349|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|12.12|||||TWO_SIDED|95.0|0.32|22.58|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to any ARI during the RSV seasons in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||22.58|0.32|
71060502|NCT04620746|141628385|SUPERIORITY|||||||0.98|||||||Chi-squared, Corrected|||||||0.98
71060503|NCT04620746|141628386|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
70936569|NCT01263496|141373337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.517|||||TWO_SIDED|95.0|-8.151|9.184||||||||9.184|-8.151|
70936570|NCT01263496|141373337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.277|||||TWO_SIDED|95.0|-2.191|4.744||||||||4.744|-2.191|
70936571|NCT01263496|141373338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.841|||||TWO_SIDED|95.0|0.239|1.443||||||||1.443|0.239|
71060504|NCT02777372|141628411|OTHER|||||||0.139|||||||Regression, Linear|||Effect of group on differences in ASR t scores from follicular to luteal.||||0.139
71060505|NCT02777372|141628412|OTHER|||||||0.843||||||Effect of group on ASR t score in the first luteal phase (no medication) to the second luteal phase (sertraline).|Regression, Linear|||||||0.843
71060506|NCT02777372|141628413|OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.06
71060507|NCT04661150|141628415|SUPERIORITY||Treatment difference|23.8||||0.079|TWO_SIDED|90.0|1.3|44.7|||Chi-squared|||||44.7|1.3|0.079
71060508|NCT04661150|141628420|SUPERIORITY||Treatment difference|-4.8||||0.739|TWO_SIDED|90.0|-27.9|18.9|||Chi-squared|||||18.9|-27.9|0.739
70936572|NCT01263496|141373338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.304|||||TWO_SIDED|95.0|0.679|1.93||||||||1.930|0.679|
70936573|NCT01263496|141373338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.992|||||TWO_SIDED|95.0|0.4|1.585||||||||1.585|0.400|
70936574|NCT01263496|141373338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.263|||||TWO_SIDED|95.0|0.674|1.853||||||||1.853|0.674|
70936575|NCT01263496|141373339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.891|||||TWO_SIDED|95.0|9.597|22.184||||||||22.184|9.597|
70936576|NCT01263496|141373339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.026|||||TWO_SIDED|95.0|12.466|23.585||||||||23.585|12.466|
70936577|NCT01263496|141373339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.838|||||TWO_SIDED|95.0|14.379|25.297||||||||25.297|14.379|
70936578|NCT01263496|141373339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.368|||||TWO_SIDED|95.0|8.677|22.06||||||||22.060|8.677|
70936579|NCT01263496|141373340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.323|||||TWO_SIDED|95.0|6.567|22.079||||||||22.079|6.567|
70936580|NCT01263496|141373340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.714|||||TWO_SIDED|95.0|14.563|26.864||||||||26.864|14.563|
70936581|NCT01263496|141373340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.063|||||TWO_SIDED|95.0|13.125|25.002||||||||25.002|13.125|
70936582|NCT01263496|141373340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.233|||||TWO_SIDED|95.0|6.618|23.847||||||||23.847|6.618|
70936583|NCT01263496|141373341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.047|||||TWO_SIDED|95.0|1.169|14.924||||||||14.924|1.169|
70936584|NCT01263496|141373341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.95|||||TWO_SIDED|95.0|7.767|20.133||||||||20.133|7.767|
70936585|NCT01263496|141373341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.221|||||TWO_SIDED|95.0|9.191|21.251||||||||21.251|9.191|
70936586|NCT01263496|141373341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.366|||||TWO_SIDED|95.0|5.847|20.885||||||||20.885|5.847|
70936587|NCT01263496|141373342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.719|||||TWO_SIDED|95.0|1.657|13.782||||||||13.782|1.657|
70936588|NCT01263496|141373342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.978|||||TWO_SIDED|95.0|7.556|18.399||||||||18.399|7.556|
70936589|NCT01263496|141373342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.076|||||TWO_SIDED|95.0|9.808|20.345||||||||20.345|9.808|
70936590|NCT01263496|141373342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.087|||||TWO_SIDED|95.0|6.561|19.614||||||||19.614|6.561|
71060509|NCT04661150|141628421|SUPERIORITY||Treatment difference|4.8|||>|0.999|TWO_SIDED|90.0|-10.9|21.4|||Fisher Exact|||||21.4|-10.9|>0.999
71060510|NCT01197911|141628424|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|1.148|||||TWO_SIDED|90.0|0.9293|1.4182||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available.||1.4182|0.9293|
71060511|NCT01197911|141628424|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|1.5518|||||TWO_SIDED|90.0|1.2468|1.9314||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available. One Participant with moderate hepatic impairment was not included in the statistical analysis of the PK parameters as there was no appropriate participant with normal hepatic function match.||1.9314|1.2468|
71060512|NCT01197911|141628426|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|0.9477|||||TWO_SIDED|90.0|0.7908|1.1356||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available.||1.1356|0.7908|
71060513|NCT01197911|141628426|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|1.0782|||||TWO_SIDED|90.0|0.8941|1.3002||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available. One Participant with moderate hepatic impairment was not included in the statistical analysis of the PK parameters as there was no appropriate participant with normal hepatic function match.||1.3002|0.8941|
71060514|NCT01197911|141628440|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|1.2323|||||TWO_SIDED|90.0|0.9618|1.5789||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available.||1.5789|0.9618|
71060515|NCT01197911|141628440|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|1.5587|||||TWO_SIDED|90.0|1.2165|1.9971||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available. One participant with moderate hepatic impairment was not included in the statistical analysis of the PK parameters as there was no appropriate participant with normal hepatic function match.||1.9971|1.2165|
71060516|NCT01197911|141628441|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|1.0027|||||TWO_SIDED|90.0|0.8049|1.2492||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available.||1.2492|0.8049|
71060517|NCT01197911|141628441|SUPERIORITY_OR_OTHER||GeometricLeast-Squares Mean Ratio|1.2254|||||TWO_SIDED|90.0|0.9836|1.5266||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available. One participant with moderate hepatic impairment was not included in the statistical analysis of the PK parameters as there was no appropriate participant with normal hepatic function match.||1.5266|0.9836|
71060518|NCT01526057|141628464|EQUIVALENCE|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and area under the serum concentration-time curve (AUC) from time 0 extrapolated to infinite time (AUC 0-inf) are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|105.67|||||TWO_SIDED|90.0|96.91|115.21|||||Rituximab-Pfizer is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way analysis of variance (ANOVA) model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||115.21|96.91|
71060519|NCT01526057|141628464|EQUIVALENCE|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC 0-inf are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|106.62|||||TWO_SIDED|90.0|97.65|116.41|||||Rituximab-Pfizer is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||116.41|97.65|
71060520|NCT01526057|141628464|EQUIVALENCE|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC 0-inf are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|100.9|||||TWO_SIDED|90.0|92.38|110.2|||||Rituximab-EU is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||110.20|92.38|
71060521|NCT01526057|141628465|EQUIVALENCE|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC0-inf are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|104.19|||||TWO_SIDED|90.0|92.75|117.06||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||117.06|92.75|
71060522|NCT01526057|141628465|EQUIVALENCE|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC0-inf are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|100.45|||||TWO_SIDED|90.0|89.2|113.11||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||113.11|89.20|
70936591|NCT01263496|141373343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.76|||||TWO_SIDED|95.0|-7.03|20.55||||||||20.55|-7.03|
70936592|NCT01263496|141373343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.85|||||TWO_SIDED|95.0|-1.49|25.19||||||||25.19|-1.49|
70936593|NCT01263496|141373343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.72|||||TWO_SIDED|95.0|-5.12|24.56||||||||24.56|-5.12|
70936594|NCT01263496|141373343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|||||TWO_SIDED|95.0|-13.26|14.9||||||||14.90|-13.26|
70936595|NCT01263496|141373344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9|||||TWO_SIDED|95.0|-11.11|22.91||||||||22.91|-11.11|
70936596|NCT01263496|141373344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.57|||||TWO_SIDED|95.0|-7.21|28.35||||||||28.35|-7.21|
70936597|NCT01263496|141373344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.45|||||TWO_SIDED|95.0|-10.08|26.98||||||||26.98|-10.08|
71060523|NCT01526057|141628465|EQUIVALENCE|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC0-inf are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|96.4|||||TWO_SIDED|90.0|85.57|108.6||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||108.60|85.57|
71060524|NCT01526057|141628466|SUPERIORITY||Test-to-reference ratio: adjusted means|103.74|||||TWO_SIDED|90.0|95.1|113.12|||||Rituximab-Pfizer is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||113.12|95.10|
71060525|NCT01526057|141628466|SUPERIORITY||Test-to-reference ratio: adjusted means|105.56|||||TWO_SIDED|90.0|96.64|115.3|||||Rituximab-Pfizer is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||115.30|96.64|
70936598|NCT01263496|141373344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.82|||||TWO_SIDED|95.0|-10.67|24.3||||||||24.30|-10.67|
71060526|NCT01526057|141628466|SUPERIORITY||Test-to-reference ratio: adjusted means|101.76|||||TWO_SIDED|90.0|93.13|111.18|||||Rituximab-EU is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data.||111.18|93.13|
71060527|NCT01526057|141628467|SUPERIORITY||Test-to-reference ratio: adjusted means|103.36|||||TWO_SIDED|90.0|92.81|115.12||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||115.12|92.81|
71060528|NCT01526057|141628467|SUPERIORITY||Test-to-reference ratio: adjusted means|101.33|||||TWO_SIDED|90.0|90.82|113.04||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||113.04|90.82|
71060529|NCT01526057|141628467|SUPERIORITY||Test-to-reference ratio: adjusted means|98.03|||||TWO_SIDED|90.0|87.83|109.4||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||109.40|87.83|
70936599|NCT01263496|141373345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.09|||||TWO_SIDED|95.0|-14.95|21.13||||||||21.13|-14.95|
70936600|NCT01263496|141373345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.48|||||TWO_SIDED|95.0|-15.61|20.57||||||||20.57|-15.61|
70936601|NCT01263496|141373345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-21.0|19.68||||||||19.68|-21.00|
70936602|NCT01263496|141373345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29|||||TWO_SIDED|95.0|-17.47|20.05||||||||20.05|-17.47|
70936603|NCT01263496|141373346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.08|||||TWO_SIDED|95.0|-11.7|19.86||||||||19.86|-11.70|
70936604|NCT01263496|141373346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.94|||||TWO_SIDED|95.0|-11.14|21.03||||||||21.03|-11.14|
70936605|NCT01263496|141373346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.65|||||TWO_SIDED|95.0|-14.42|21.73||||||||21.73|-14.42|
70936606|NCT01263496|141373346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|||||TWO_SIDED|95.0|-17.24|15.89||||||||15.89|-17.24|
70936607|NCT02432274|141373365|OTHER||||||=|0.20359|||||||Wilcoxon Rank-Sum Test|||C2D1: FGF 19 (PFS-4, Yes) vs. C2D1: FGF 19 (PFS-4, No)||||=0.20359
70936608|NCT02432274|141373365|OTHER||||||=|0.50068|||||||Wilcoxon Rank-Sum Test|||C2D1: FGF 19 (PFS-4, Yes) vs. C2D1: FGF 19 (PFS-4, No)||||=0.50068
70936609|NCT02432274|141373365|OTHER||||||=|0.05512|||||||Wilcoxon Rank-Sum Test|||C3D1: FGF 19 (PFS-4, Yes) vs. C3D1: FGF 19 (PFS-4, No)||||=0.05512
70936610|NCT02432274|141373365|OTHER||||||=|0.50382|||||||Wilcoxon Rank-Sum Test|||C4D1: FGF 19 (PFS-4, Yes) vs. C4D1: FGF 19 (PFS-4, No)||||=0.50382
70936611|NCT02432274|141373365|OTHER||||||=|0.0476|||||||Wilcoxon Rank-Sum Test|||C2D1: FGF 21 (PFS-4, Yes) vs. C2D1: FGF 21 (PFS-4, No)||||=0.04760
70936612|NCT02432274|141373365|OTHER||||||=|0.2142|||||||Wilcoxon Rank-Sum Test|||C2D1: FGF 21 (PFS-4, Yes) vs. C2D1: FGF 21 (PFS-4, No)||||=0.21420
70936613|NCT02432274|141373365|OTHER||||||=|0.42542|||||||Wilcoxon Rank-Sum Test|||C3D1: FGF 21 (PFS-4, Yes) vs. C3D1: FGF 21 (PFS-4, No)||||=0.42542
70936614|NCT02432274|141373365|OTHER||||||=|0.73573|||||||Wilcoxon Rank-Sum Test|||C4D1: FGF 21 (PFS-4, Yes) vs. C4D1: FGF 21 (PFS-4, No)||||=0.73573
70936615|NCT02432274|141373365|OTHER||||||=|0.35754|||||||Wilcoxon Rank-Sum Test|||C2D1: VEGF (PFS-4, Yes) vs. C2D1: VEGF (PFS-4, No)||||=0.35754
70936616|NCT02432274|141373365|OTHER||||||=|0.59903|||||||Wilcoxon Rank-Sum Test|||C2D1: VEGF (PFS-4, Yes) vs. C2D1: VEGF (PFS-4, No)||||=0.59903
70936617|NCT02432274|141373365|OTHER||||||=|1|||||||Wilcoxon Rank-Sum Test|||C3D1: VEGF (PFS-4, Yes) vs. C3D1: VEGF (PFS-4, No)||||=1.00000
70936618|NCT00286325|141373388|SUPERIORITY_OR_OTHER||||||=|0.0156||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon comparing week zero antibody value in units to week 24 antibody value in units||||=0.0156
70936619|NCT00286325|141373389|SUPERIORITY_OR_OTHER||||||=|0.0078|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Comparison of B cell number at week 0 to b cell number in participants at week 24||||=0.0078
71060530|NCT01526057|141628486|SUPERIORITY||Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.31|1.78|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 3.||1.78|0.31|
71060531|NCT01526057|141628486|SUPERIORITY||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.6|1.88|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 5.||1.88|0.60|
71060532|NCT01526057|141628486|SUPERIORITY||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.66|1.73|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 9.||1.73|0.66|
71060533|NCT01526057|141628486|SUPERIORITY||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.73|1.56|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 13.||1.56|0.73|
71060534|NCT01526057|141628486|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.68|1.62|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 17.||1.62|0.68|
71060535|NCT01526057|141628486|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.66|1.69|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 21.||1.69|0.66|
71060536|NCT01526057|141628486|SUPERIORITY||Risk Ratio (RR)|1.19|||||TWO_SIDED|95.0|0.7|2.0|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 25 (EOT).||2.00|0.70|
71060537|NCT01526057|141628486|SUPERIORITY||Risk Ratio (RR)|0.7|||||TWO_SIDED|95.0|0.28|1.73|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 3.||1.73|0.28|
71060538|NCT01526057|141628486|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.43|1.54|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 5.||1.54|0.43|
71060539|NCT01526057|141628486|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.49|1.42|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 9.||1.42|0.49|
71060540|NCT01526057|141628486|SUPERIORITY||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.5|1.22|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 13.||1.22|0.50|
71060541|NCT01526057|141628486|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.57|1.44|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 17.||1.44|0.57|
71060542|NCT01526057|141628486|SUPERIORITY||Risk Ratio (RR)|1.36|||||TWO_SIDED|95.0|0.88|2.1|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 21.||2.10|0.88|
71060543|NCT01526057|141628486|SUPERIORITY||Risk Ratio (RR)|1.31|||||TWO_SIDED|95.0|0.78|2.18|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 25 (EOT).||2.18|0.78|
71060544|NCT01526057|141628486|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.36|2.45|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 3.||2.45|0.36|
71060545|NCT01526057|141628486|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.41|1.44|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 5.||1.44|0.41|
71060546|NCT01526057|141628486|SUPERIORITY||Risk Ratio (RR)|0.78|||||TWO_SIDED|95.0|0.47|1.31|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 9.||1.31|0.47|
71060547|NCT01526057|141628486|SUPERIORITY||Risk Ratio (RR)|0.74|||||TWO_SIDED|95.0|0.48|1.13|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 13.||1.13|0.48|
71060548|NCT01526057|141628486|SUPERIORITY||Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.55|1.36|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 17.||1.36|0.55|
71060549|NCT01526057|141628486|SUPERIORITY||Risk Ratio (RR)|1.29|||||TWO_SIDED|95.0|0.85|1.95|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 21.||1.95|0.85|
71060550|NCT01526057|141628486|SUPERIORITY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.7|1.73|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 25 (EOT).||1.73|0.70|
71060551|NCT01526057|141628487|SUPERIORITY||Risk Ratio (RR)|0.47|||||TWO_SIDED|95.0|0.12|1.79|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 3.||1.79|0.12|
71060552|NCT01526057|141628487|SUPERIORITY||Risk Ratio (RR)|0.5|||||TWO_SIDED|95.0|0.2|1.26|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 5.||1.26|0.20|
71060553|NCT01526057|141628487|SUPERIORITY||Risk Ratio (RR)|0.78|||||TWO_SIDED|95.0|0.43|1.41|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 9.||1.41|0.43|
71060554|NCT01526057|141628487|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.61|1.74|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 13.||1.74|0.61|
71060555|NCT01526057|141628487|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.56|1.74|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 17.||1.74|0.56|
71060556|NCT01526057|141628487|SUPERIORITY||Risk Ratio (RR)|0.68|||||TWO_SIDED|95.0|0.34|1.36|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 21.||1.36|0.34|
71060557|NCT01526057|141628487|SUPERIORITY||Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.46|1.63|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 25 (EOT).||1.63|0.46|
71060558|NCT01526057|141628487|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.27|2.6|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 3.||2.60|0.27|
71060559|NCT01526057|141628487|SUPERIORITY||Risk Ratio (RR)|0.71|||||TWO_SIDED|95.0|0.31|1.62|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 5.||1.62|0.31|
71060560|NCT01526057|141628487|SUPERIORITY||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.41|1.4|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 9.||1.40|0.41|
71060561|NCT01526057|141628487|SUPERIORITY||Risk Ratio (RR)|0.89|||||TWO_SIDED|95.0|0.51|1.57|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 13.||1.57|0.51|
71060562|NCT01526057|141628487|SUPERIORITY||Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.51|1.68|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 17.||1.68|0.51|
71060563|NCT01526057|141628487|SUPERIORITY||Risk Ratio (RR)|1.22|||||TWO_SIDED|95.0|0.68|2.19|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 21.||2.19|0.68|
71060564|NCT01526057|141628487|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.44|1.62|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 25 (EOT).||1.62|0.44|
71060565|NCT01526057|141628487|SUPERIORITY||Risk Ratio (RR)|1.79|||||TWO_SIDED|95.0|0.44|7.2|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 3.||7.20|0.44|
71060566|NCT01526057|141628487|SUPERIORITY||Risk Ratio (RR)|1.41|||||TWO_SIDED|95.0|0.52|3.86|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 5.||3.86|0.52|
71060567|NCT01526057|141628487|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.51|1.87|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 9.||1.87|0.51|
71060568|NCT01526057|141628487|SUPERIORITY||Risk Ratio (RR)|0.87|||||TWO_SIDED|95.0|0.5|1.5|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 13.||1.50|0.50|
71060569|NCT01526057|141628487|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.52|1.69|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 17.||1.69|0.52|
71060570|NCT01526057|141628487|SUPERIORITY||Risk Ratio (RR)|1.8|||||TWO_SIDED|95.0|0.93|3.5|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 21.||3.50|0.93|
71060571|NCT01526057|141628487|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.51|1.89|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 25 (EOT).||1.89|0.51|
71060572|NCT02289729|141628494|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
71060573|NCT02289729|141628495|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
71060574|NCT02289729|141628496|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
71060575|NCT02289729|141628497|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
71060576|NCT02289729|141628498|SUPERIORITY|||||||0.0328|||||||t-test|||||||0.0328
71060577|NCT02289729|141628499|SUPERIORITY|||||||0.4183|||||||t-test|||||||0.4183
71060578|NCT02289729|141628500|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
71060579|NCT02289729|141628501|SUPERIORITY|||||||0.0003|||||||t-test|||||||0.0003
71060580|NCT02289729|141628502|SUPERIORITY|||||||0.0109|||||||t-test|||||||0.0109
71060581|NCT02289729|141628503|SUPERIORITY|||||||0.0002|||||||t-test|||||||0.0002
71060582|NCT02289729|141628504|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
71060583|NCT02289729|141628505|SUPERIORITY|||||||0.0002|||||||signed-rank test|||||||0.0002
71060584|NCT02289729|141628506|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
71060585|NCT02289729|141628507|SUPERIORITY|||||||0.0038|||||||t-test|||||||0.0038
71060586|NCT02289729|141628508|SUPERIORITY||||||<|0.0001|||||||signed-rank test|||||||< 0.0001
71060587|NCT02289729|141628509|SUPERIORITY|||||||0.0274|||||||signed-rank test|||||||0.0274
71060588|NCT02289729|141628510|SUPERIORITY||||||<|0.0001|||||||signed-rank test|||||||< 0.0001
71060589|NCT02289729|141628511|SUPERIORITY|||||||0.0006|||||||t-test|||||||0.0006
71060590|NCT02289729|141628512|SUPERIORITY|||||||0.001|||||||signed-rank test|||||||0.0010
71060591|NCT02289729|141628513|SUPERIORITY|||||||0.0002|||||||t-test|||||||0.0002
71060592|NCT02289729|141628514|SUPERIORITY|||||||0.0297|||||||t-test|||||||0.0297
71060593|NCT02289729|141628515|SUPERIORITY|||||||0.0279|||||||t-test|||||||0.0279
71060594|NCT02289729|141628516|SUPERIORITY|||||||0.2777|||||||t-test|||||||0.2777
71060595|NCT02289729|141628517|SUPERIORITY|||||||0.0047|||||||t-test|||||||0.0047
71060596|NCT02289729|141628518|SUPERIORITY|||||||0.0003|||||||t-test|||||||0.0003
71060597|NCT02289729|141628519|SUPERIORITY||||||<|0.5877|||||||t-test|||||||<0.5877
71060598|NCT02289729|141628520|SUPERIORITY|||||||0.0002|||||||t-test|||||||0.0002
71060599|NCT02289729|141628521|SUPERIORITY||||||<|0.0001|||||||t-test|||||||<0.0001
71060600|NCT02289729|141628522|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
71060601|NCT02289729|141628523|SUPERIORITY||||||<|0.0001|||||||signed-rank test|||||||< 0.0001
71060602|NCT02289729|141628524|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
71060603|NCT02289729|141628525|SUPERIORITY|||||||0.0001|||||||t-test|||||||0.0001
71060604|NCT02289729|141628526|SUPERIORITY||||||<|0.0001|||||||signed-rank test|||||||< 0.0001
71060605|NCT02289729|141628527|SUPERIORITY|||||||0.2428|||||||signed-rank test|||||||0.2428
71060606|NCT02289729|141628528|SUPERIORITY|||||||0.0687|||||||t-test|||||||0.0687
71060607|NCT02289729|141628529|SUPERIORITY|||||||0.3126|||||||t-test|||||||0.3126
71060608|NCT02289729|141628530|SUPERIORITY|||||||0.1533|||||||t-test|||||||0.1533
71060609|NCT02289729|141628531|SUPERIORITY|||||||0.8145|||||||t-test|||||||0.8145
71060610|NCT02289729|141628532|SUPERIORITY|||||||0.4048|||||||t-test|||||||0.4048
71060611|NCT02289729|141628533|SUPERIORITY|||||||0.8321|||||||t-test|||||||0.8321
71060612|NCT02289729|141628534|SUPERIORITY|||||||0.1945|||||||signed-rank test|||||||0.1945
71060613|NCT02289729|141628535|SUPERIORITY|||||||0.7937|||||||t-test|||||||0.7937
71060614|NCT02289729|141628536|SUPERIORITY|||||||0.0234|||||||signed-rank test|||||||0.0234
71060615|NCT02289729|141628537|SUPERIORITY|||||||0.5922|||||||t-test|||||||0.5922
71060616|NCT02289729|141628538|SUPERIORITY|||||||1|||||||t-test|||||||1.000
71060617|NCT02289729|141628539|SUPERIORITY|||||||0.6481|||||||t-test|||||||0.6481
71060618|NCT02289729|141628540|SUPERIORITY|||||||0.6741|||||||t-test|||||||0.6741
71060619|NCT02289729|141628541|OTHER||Fisher's z|0.27846||||0.0389|TWO_SIDED|95.0|0.014175|0.495059|||Fisher's z Transformation|||PDQ-39 with UPDRS-III||0.495059|0.014175|0.0389
71060620|NCT02289729|141628541|OTHER||Fisher's z|0.07359||||0.5852|TWO_SIDED|95.0|-0.188409|0.32558|||Fisher's z Transformation|||PDQ-39 with UPDRS-IV||0.325580|-0.188409|0.5852
71060621|NCT02289729|141628541|OTHER||Fisher's z|0.21311||||0.114|TWO_SIDED|95.0|-0.051127|0.444152|||Fisher's z Transformation|||PDQ-39 with NMSS||0.444152|-0.051127|0.1140
71109906|NCT04683913|141724897|OTHER|||||||0.162||||||Week 3\&4 vs Retention|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.162
71109907|NCT04683913|141724897|OTHER|||||||0.421||||||Week 5\&6 vs Retention|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.421
71109908|NCT04683913|141724902|SUPERIORITY|||||||0.75|||||||ANCOVA|Controlling for baseline scores, structural severity and sex. alpha=0.05||Knee Injury and Osteoarthritis Outcome Scale - pain subscale scores were compared between the delayed and immediate groups at week 6 using ANCOVA.||||0.750
71109909|NCT04683913|141724902|SUPERIORITY|||||||0.201|||||||ANCOVA|Controlling for baseline scores, structural severity and sex. alpha=0.05||Knee Injury and Osteoarthritis Outcome Scale - stiffness subscale scores were compared between the delayed and immediate groups at week 6 using ANCOVA.||||0.201
71060622|NCT02289729|141628541|OTHER||Fisher's z|0.29062||||0.0311|TWO_SIDED|95.0|0.026334|0.504186|||Fisher's z Transformation|||PDQ-39 with BAI||0.504186|0.026334|0.0311
71060623|NCT02289729|141628541|OTHER||Fisher's z|0.49952||||0.0002|TWO_SIDED|95.0|0.230995|0.643312|||Fisher's z Transformation|||PDQ-39 with BDI-II||0.643312|0.230995|0.0002
71060624|NCT02289729|141628541|OTHER||Fisher's z|0.08869||||0.5146|TWO_SIDED|95.0|-0.176169|0.341163|||Fisher's z Transformation|||PDQ-39 with AS||0.341163|-0.176169|0.5146
71060625|NCT02289729|141628541|OTHER||Fisher's z|0.34688||||0.0108|TWO_SIDED|95.0|0.079996|0.546657|||Fisher's z Transformation|||PDQ-39 with PFS||0.546657|0.079996|0.0108
71060626|NCT02289729|141628541|OTHER||Fisher's z|0.22455||||0.0989|TWO_SIDED|95.0|-0.042139|0.455224|||Fisher's z Transformation|||PDQ-39 with NBL A-S||0.455224|-0.042139|0.0989
71060627|NCT02289729|141628541|OTHER||Fisher's z|0.35742||||0.006|TWO_SIDED|95.0|0.106797|0.565335|||Fisher's z Transformation|||PDQ-39 with NBL C-D||0.565335|0.106797|0.0060
71060628|NCT02289729|141628541|OTHER||Fisher's z|0.00011||||0.9993|TWO_SIDED|95.0|-0.260462|0.260673|||Fisher's z Transformation|||PDQ-39 with NBL C-R||0.260673|-0.260462|0.9993
71060629|NCT02289729|141628541|OTHER||Fisher's z|-0.36687||||0.0088|TWO_SIDED|95.0|-0.565795|-0.092154|||Fisher's z Transformation|||PDQ-39 with ZBI||-0.092154|-0.565795|0.0088
71060630|NCT02289729|141628541|OTHER||Fisher's z|0.21643||||0.1222|TWO_SIDED|95.0|-0.057959|0.454911|||Fisher's z Transformation|||PDQ-39 with Goldberg-Anxiety||0.454911|-0.057959|0.1222
71060631|NCT02289729|141628541|OTHER||Fisher's z|0.57423||||0.0041|TWO_SIDED|95.0|0.180247|0.74704|||Fisher's z Transformation|||PDQ-39 with Goldberg-Depression||0.747040|0.180247|0.0041
71060632|NCT02289729|141628542|OTHER||Fisher's z|0.31946||||0.0239|TWO_SIDED|95.0|0.042257|0.534657|||Fisher's z Transformation|||PDQ-39 with UPDRS-III||0.534657|0.042257|0.0239
71060633|NCT02289729|141628542|OTHER||Fisher's z|0.36796||||0.0093|TWO_SIDED|95.0|0.090528|0.568388|||Fisher's z Transformation|||PDQ-39 with UPDRS-IV||0.568388|0.090528|0.0093
71060634|NCT02289729|141628542|OTHER||Fisher's z|0.38627||||0.0069|TWO_SIDED|95.0|0.105875|0.582517|||Fisher's z Transformation|||PDQ-39 with NMSS||0.582517|0.105875|0.0069
71060635|NCT02289729|141628542|OTHER||Fisher's z|0.70289|||<|0.0001|TWO_SIDED|95.0|0.40173|0.753097|||Fisher's z Transformation|||PDQ-39 with BAI||0.753097|0.401730|< 0.0001
71060636|NCT02289729|141628542|OTHER||Fisher's z|0.63758|||<|0.0001|TWO_SIDED|95.0|0.345567|0.72341|||Fisher's z Transformation|||PDQ-39 with BDI-II||0.723410|0.345567|<0.0001
71060637|NCT02289729|141628542|OTHER||Fisher's z|0.24114||||0.0882|TWO_SIDED|95.0|-0.036024|0.476404|||Fisher's z Transformation|||PDQ-39 with AS||0.476404|-0.036024|0.0882
71060638|NCT02289729|141628542|OTHER||Fisher's z|0.67113|||<|0.0001|TWO_SIDED|95.0|0.374757|0.739016|||Fisher's z Transformation|||PDQ-39 with PFS||0.739016|0.374757|< 0.0001
71060639|NCT02289729|141628542|OTHER||Fisher's z|0.60612|||<|0.0001|TWO_SIDED|95.0|0.317572|0.708072|||Fisher's z Transformation|||PDQ-39 with NBL A-S||0.708072|0.317572|< 0.0001
71060640|NCT02289729|141628542|OTHER||Fisher's z|0.60613|||<|0.0001|TWO_SIDED|95.0|0.31758|0.708076|||Fisher's z Transformation|||PDQ-39 with NBL C-D||0.708076|0.317580|< 0.0001
71060641|NCT02289729|141628542|OTHER||Fisher's z|0.41143||||0.0036|TWO_SIDED|95.0|0.133445|0.597087|||Fisher's z Transformation|||PDQ-39 with NBL C-R||0.597087|0.133445|0.0036
71060642|NCT02289729|141628542|OTHER||Fisher's z|-0.33661||||0.0239|TWO_SIDED|95.0|-0.557217|-0.044411|||Fisher's z Transformation|||PDQ-39 with ZBI||-0.044411|-0.557217|0.0239
71109910|NCT04683913|141724902|SUPERIORITY|||||||0.997|||||||ANCOVA|Controlling for baseline scores, structural severity and sex. alpha=0.05||Knee Injury and Osteoarthritis Outcome Scale - physical function subscale scores were compared between the delayed and immediate groups at week 6 using ANCOVA.||||0.997
71109911|NCT04683913|141724902|SUPERIORITY|||||||0.423|||||||ANCOVA|Controlling for baseline scores, structural severity and sex. alpha=0.05||Knee Injury and Osteoarthritis Outcome Scale - quality of life subscale scores were compared between the delayed and immediate groups at week 6 using ANCOVA.||||0.423
71109912|NCT04683913|141724903|SUPERIORITY|||||||0.342|||||||ANCOVA|Controlling for body mass, structural severity and sex. alpha=0.05||Knee adduction moment 1 (early stance) was analyzed as raw Nm with body mass entered as as covariate.||||0.342
71109913|NCT04683913|141724903|SUPERIORITY|||||||0.844|||||||ANCOVA|Controlling for body mass, structural severity and sex. alpha=0.05||Knee Adduction Moment 2 (late stance was analyzed as raw Nm with body mass entered as as covariate.||||0.844
71109914|NCT04683913|141724903|SUPERIORITY|||||||0.774|||||||ANCOVA|Controlling for body mass, structural severity and sex. alpha=0.05||Knee Flexion Moments were analyzed as raw Nm with body mass entered as as covariate||||0.774
71109915|NCT04683913|141724904|SUPERIORITY|||||||0.186|||||||ANCOVA|Controlling for body mass, structural severity and sex. alpha=0.05||Knee adduction moment impulses were analyzed as raw Nm\*s with body mass entered as as covariate.||||0.186
71060643|NCT02289729|141628542|OTHER||Fisher's z|0.64565|||<|0.0001|TWO_SIDED|95.0|0.339454|0.734221|||Fisher's z Transformation|||PDQ-39 with Goldberg-Anxiety||0.734221|0.339454|< 0.0001
71060644|NCT02289729|141628542|OTHER||Fisher's z|0.10898||||0.7058|TWO_SIDED|95.0|-0.427482|0.588111|||Fisher's z Transformation|||PDQ-39 with Goldberg-Depression||0.588111|-0.427482|0.7058
71060645|NCT02289729|141628543|OTHER||Fisher's z|-0.57271|||<|0.0001|TWO_SIDED|95.0|-0.689585|-0.289724|||Fisher's z Transformation|||SQLC with ZBI||-0.289724|-0.689585|< 0.0001
71060646|NCT02289729|141628543|OTHER||Fisher's z|-0.16332||||0.4142|TWO_SIDED|95.0|-0.504489|0.224771|||Fisher's z Transformation|||SQLC with Goldberg Anxiety||0.224771|-0.504489|0.4142
71060647|NCT02289729|141628543|OTHER||Fisher's z|-0.48143||||0.0239|TWO_SIDED|95.0|-0.715956|-0.063481|||Fisher's z Transformation|||SQLC with Goldberg Depression||-0.063481|-0.715956|0.0239
71060648|NCT02289729|141628543|OTHER||Fisher's z|0.06326||||0.6546|TWO_SIDED|95.0|-0.210715|0.327872|||Fisher's z Transformation|||SQLC with NBL A-S||0.327872|-0.210715|0.6546
71060649|NCT02289729|141628543|OTHER||Fisher's z|0.17674||||0.2114|TWO_SIDED|95.0|-0.100105|0.425116|||Fisher's z Transformation|||SQLC with NBL C-D||0.425116|-0.100105|0.2114
71060650|NCT02289729|141628543|OTHER||Fisher's z|0.2944||||0.0374|TWO_SIDED|95.0|0.017222|0.516523|||Fisher's z Transformation|||SQLC with NBL C-R||0.516523|0.017222|0.0374
71060651|NCT02289729|141628543|OTHER||Fisher's z|-0.36687||||0.0088|TWO_SIDED|95.0|-0.565795|-0.092154|||Fisher's z Transformation|||SQLC with Global PDQ-39||-0.092154|-0.565795|0.0088
71109916|NCT04683913|141724904|SUPERIORITY|||||||0.601|||||||ANCOVA|Controlling for body mass, structural severity and sex. alpha=0.05||Knee flexion moment impulses were analyzed as raw Nm\*s with body mass entered as as covariate.||||0.601
71060652|NCT02289729|141628543|OTHER||Fisher's z|-0.13433||||0.3374|TWO_SIDED|95.0|-0.387439|0.139207|||Fisher's z Transformation|||SQLC with UPDRS-III||0.139207|-0.387439|0.3374
71060653|NCT02289729|141628543|OTHER||Fisher's z|0.17846||||0.2025|TWO_SIDED|95.0|-0.095693|0.424291|||Fisher's z Transformation|||SQLC with UPDRS-IV||0.424291|-0.095693|0.2025
71060654|NCT02289729|141628543|OTHER||Fisher's z|0.01625||||0.9076|TWO_SIDED|95.0|-0.252613|0.282777|||Fisher's z Transformation|||SQLC with Global NMSS||0.282777|-0.252613|0.9076
71060655|NCT02289729|141628544|OTHER||Fisher's z|-0.7468|||<|0.0001|TWO_SIDED|95.0|-0.777482|-0.425693|||Fisher's z Transformation|||SQLC with ZBI||-0.425693|-0.777482|< 0.0001
71060656|NCT02289729|141628544|OTHER||Fisher's z|0.17924||||0.5347|TWO_SIDED|95.0|-0.368382|0.632178|||Fisher's z Transformation|||SQLC with Goldberg Anxiety||0.632178|-0.368382|0.5347
71060657|NCT02289729|141628544|OTHER||Fisher's z|-0.06987||||0.8251|TWO_SIDED|95.0|-0.597767|0.500464|||Fisher's z Transformation|||SQLC with Goldberg Depression||0.500464|-0.597767|0.8251
71060658|NCT02289729|141628544|OTHER||Fisher's z|-0.1106||||0.4581|TWO_SIDED|95.0|-0.382323|0.179601|||Fisher's z transformation|||SQLC with NBL A-S||0.179601|-0.382323|0.4581
71060659|NCT02289729|141628544|OTHER||Fisher's z|0.00326||||0.9826|TWO_SIDED|95.0|-0.281136|0.287128|||Fisher's z Transformation|||SQLC with NBL C-D||0.287128|-0.281136|0.9826
71060660|NCT02289729|141628544|OTHER||Fisher's z|-0.10293||||0.4899|TWO_SIDED|95.0|-0.375749|0.187021|||Fisher's z Transformation|||SQLC with NBL C-R||0.187021|-0.375749|0.4899
71060661|NCT02289729|141628544|OTHER||Fisher's z|-0.33661||||0.0239|TWO_SIDED|95.0|-0.557217|-0.044411|||Fisher's z Transformation|||SQLC with Global PDQ-39||-0.044411|-0.557217|0.0239
71060662|NCT02289729|141628544|OTHER||Fisher's z|-0.23658||||0.1125|TWO_SIDED|95.0|-0.484427|0.055538|||Fisher's z Transformation|||SQLC with UPDRS-III||0.055538|-0.484427|0.1125
71060663|NCT02289729|141628544|OTHER||Fisher's z|-0.13015||||0.3826|TWO_SIDED|95.0|-0.398887|0.16062|||Fisher's z Transformation|||SQLC with UPDRS-IV||0.160620|-0.398887|0.3826
71060664|NCT02289729|141628544|OTHER||Fisher's z|0.11688||||0.4382|TWO_SIDED|95.0|-0.176724|0.390468|||Fisher's z Transformation|||SQLC with Global NMSS||0.390468|-0.176724|0.4382
71060665|NCT01875978|141628545|SUPERIORITY_OR_OTHER||||||<|0.05||||||P-value \<0.05 is significance meaningful.|t-test, 1 sided|Student's t-test, 1 sided||Hypothesis: phytosterols improve metabolic status||||<0.05
71060666|NCT01875978|141628546|SUPERIORITY_OR_OTHER||||||<|0.05||||||P value \<0.05 for statistical significance|t-test, 1 sided|Student's t test, 1 sided||Hypothesis: phytosterols increase the anti-oxidative capacity.||||<0.05
71060667|NCT01875978|141628547|SUPERIORITY_OR_OTHER||||||<|0.05||||||P\<0.05 for statistical significance|t-test, 1 sided|Student's t test, 1 sided||Phytosterols increase IGF-1||||<0.05
71060668|NCT01875978|141628548|SUPERIORITY_OR_OTHER||||||<|0.05||||||P value \<0.05 for statistical significance|t-test, 1 sided|Student's t-test, 1 sided||Hypothesis:phytosterols increase endothelial progenitor cells to provide endothelial repair and vessel protection||||<0.05
71060669|NCT04870710|141628556|SUPERIORITY||Median Difference (Net)|0.1||||0.1|TWO_SIDED||||||Friedman||||Non-parametric tests were used consisting of Friedman and Durbin Conover tests|||0.10
71060670|NCT05724589|141628577|SUPERIORITY|A repeated measures ANOVA was selected to analyze changes in skin hydration across four time points within the same participants..|Mean Difference (Final Values)|2.671||||1|TWO_SIDED|||||The p-value reflects the overall test for difference in hydration over time and is not adjusted for multiple comparisons. The pre-defined threshold for statistical significance was p \< 0.05.|ANOVA|No additional adjustments were applied. Degrees of freedom and sphericity assumptions were checked.|The mean difference was calculated based on changes in skin hydration from baseline to Week 16 using repeated measures ANOVA, in accordance with the pre-specified statistical analysis plan.|Skin hydration was evaluated longitudinally using repeated measures ANOVA at Baseline, Week 8, Week 12, and Week 16. This pre-specified statistical test assessed within-subject changes over time to determine the efficacy of the serum.|The overall p-value corresponds to the repeated measures ANOVA evaluating changes over four time points. No multiplicity adjustments were applied.|||1.000
71109917|NCT04343092|141724923|SUPERIORITY||Mean Difference (Final Values)|7.92||||0.05|TWO_SIDED||||||t-test, 2 sided||||Historical control population included: Hydroxychloroquin (HCQ) 400mg BID at admission day then 200mg BID for 5 days plus Azithromycin (AZT) 500mg at admission day then 250mg for 5 days.|||0.05
71109918|NCT01639469|141724943|SUPERIORITY||Incidence Rate Ratio|0.39|||<|0.001|TWO_SIDED|95.0|0.22|0.68|||Negative Binomial Regression|||Testing to see if there is a significant difference in fall rates over 12months between the two groups.||0.68|0.22|<0.001
71109919|NCT03856359|141725007|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.60
71109920|NCT03856359|141725009|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
71109921|NCT03856359|141725011|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||||||0.73
71109922|NCT03856359|141725013|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
71109923|NCT03856359|141725014|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||||||0.23
71109924|NCT03856359|141725015|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
71109925|NCT03856359|141725016|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
71109926|NCT03856359|141725017|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.7
71109927|NCT03856359|141725018|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
71109928|NCT03856359|141725019|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|||||||0.65
71109929|NCT03856359|141725020|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||||||0.18
71109930|NCT03856359|141725021|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||||||0.44
71109931|NCT03856359|141725022|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.20
71109932|NCT03856359|141725023|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||||||0.53
71109933|NCT03856359|141725024|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
71109934|NCT03856359|141725025|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
71109935|NCT00589797|141725043|NON_INFERIORITY|The trial was designed as a non-inferiority trial with a margin (delta) of 15%. Additional analyses using a delta of 10% as requested by FDA were also conducted.|||||<|0.05|TWO_SIDED|95.0|||||t-test, 1 sided|||||||<0.05
71109936|NCT01881009|141725052|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
71109937|NCT01881009|141725053|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71109938|NCT02141672|141725055|SUPERIORITY||Odds Ratio (OR)|2.03||||0.045|TWO_SIDED|95.0|1.01|4.05|||Regression, Logistic|||Voclosporin low dose vs. placebo||4.05|1.01|0.045
71109939|NCT02141672|141725055|SUPERIORITY||Odds Ratio (OR)|1.59||||0.204|TWO_SIDED|95.0|0.78|3.27|||Regression, Logistic|||Voclosporin high dose vs. placebo||3.27|0.78|0.204
71109940|NCT02141672|141725056|SUPERIORITY||Odds Ratio (OR)|3.21|||<|0.001|TWO_SIDED|95.0|1.68|6.13|||Regression, Logistic|||Voclosporin low dose vs. placebo||6.13|1.68|<0.001
71109941|NCT02141672|141725056|SUPERIORITY||Odds Ratio (OR)|2.1||||0.026|TWO_SIDED|95.0|1.09|4.02|||Regression, Logistic|||Voclosporin high dose vs. placebo||4.02|1.09|0.026
71109942|NCT02141672|141725057|SUPERIORITY||Odds Ratio (OR)|1.9||||0.066|TWO_SIDED|95.0|0.96|3.78|||Regression, Logistic|||||3.78|0.96|0.066
71109943|NCT02141672|141725057|SUPERIORITY||Odds Ratio (OR)|1.64||||0.162|TWO_SIDED|95.0|0.82|3.28|||Regression, Logistic|||||3.28|0.82|0.162
71109944|NCT02141672|141725058|SUPERIORITY||Hazard Ratio (HR)|2.26|||<|0.001|TWO_SIDED|95.0|1.45|3.51|||Regression, Cox|||Voclosporin low dose vs. placebo||3.51|1.45|<0.001
71109945|NCT02141672|141725058|SUPERIORITY||Hazard Ratio (HR)|2.25|||<|0.001|TWO_SIDED|95.0|1.46|3.47|||Regression, Cox|||Voclosporin high dose vs. placebo||3.47|1.46|<0.001
71109946|NCT02141672|141725059|SUPERIORITY||Hazard Ratio (HR)|2.89|||<|0.001|TWO_SIDED|95.0|1.58|5.29|||Regression, Cox|||||5.29|1.58|<0.001
71109947|NCT02141672|141725059|SUPERIORITY||Hazard Ratio (HR)|1.48|||<|0.248|TWO_SIDED|95.0|0.77|2.86|||Regression, Cox|||Voclosporin high dose vs. placebo||2.86|0.77|<0.248
71109948|NCT02141672|141725061|SUPERIORITY||Hazard Ratio (HR)|1.63||||0.005|TWO_SIDED|95.0|1.16|2.27|||Regression, Cox|||||2.27|1.16|0.005
71109949|NCT02141672|141725061|SUPERIORITY||Hazard Ratio (HR)|1.74||||0.002|TWO_SIDED|95.0|1.25|2.43|||Regression, Cox|||Voclosporin high dose vs. placebo||2.43|1.25|0.002
71109950|NCT02141672|141725063|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.98|TWO_SIDED|95.0|0.45|2.15|||Regression, Cox|||Voclosporin low dose vs. placebo||2.15|0.45|0.980
71109951|NCT02141672|141725063|SUPERIORITY||Hazard Ratio (HR)|1.98||||0.118|TWO_SIDED|95.0|0.95|4.16|||Regression, Cox|||Voclosporin high dose vs. placebo||4.16|0.95|0.118
71109952|NCT02141672|141725065|SUPERIORITY||Odds Ratio (OR)|2.33||||0.007|TWO_SIDED|95.0|1.26|4.33|||Regression, Logistic|||week 24||4.33|1.26|0.007
71109953|NCT02141672|141725065|SUPERIORITY||Odds Ratio (OR)|2.03||||0.024|TWO_SIDED|95.0|1.1|3.76|||Regression, Logistic|||week 24||3.76|1.1|0.024
71109954|NCT02141672|141725065|SUPERIORITY||Odds Ratio (OR)|2.34||||0.007|TWO_SIDED|95.0|1.27|4.33|||Regression, Logistic|||week 48||4.33|1.27|0.007
71109955|NCT02141672|141725065|SUPERIORITY||Odds Ratio (OR)|2.68||||0.002|TWO_SIDED|95.0|1.43|5.02|||Regression, Logistic|||week 48||5.02|1.43|0.002
71109956|NCT02141672|141725066|SUPERIORITY||Hazard Ratio (HR)|2.03|||<|0.001|TWO_SIDED|95.0|1.36|3.03|||Regression, Cox|||Voclosporin low dose vs. placebo||3.03|1.36|<0.001
71109957|NCT02141672|141725066|SUPERIORITY||Hazard Ratio (HR)|1.81||||0.004|TWO_SIDED|95.0|1.22|2.69|||Regression, Cox|||Voclosporin high dose vs. placebo||2.69|1.22|0.004
71109958|NCT02141672|141725068|SUPERIORITY||Hazard Ratio (HR)|2.21|||<|0.001|TWO_SIDED|95.0|1.45|3.36|||Regression, Cox|||Voclosporin low dose vs. placebo||3.36|1.45|<0.001
71109959|NCT02141672|141725068|SUPERIORITY||Hazard Ratio (HR)|1.87||||0.004|TWO_SIDED|95.0|1.23|2.84|||Regression, Cox|||Voclosporin high dose vs. placebo||2.84|1.23|0.004
71109960|NCT01061385|141725087|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.5||||0.2922|TWO_SIDED|95.0|-6.8|21.7|||t-test, 1 sided|||||21.7|-6.8|0.2922
71109961|NCT01061385|141725088|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0|||||TWO_SIDED|95.0|-37.7|38.0|||||The 95% CI range above is calculated for the current estimated value.|||38.0|-37.7|
71109962|NCT00533429|141725089|SUPERIORITY_OR_OTHER_LEGACY|||||||0.469||||||P-value (one-tailed) was calculated based on the un-stratified log-rank test.|Log Rank|||||||0.469
71109963|NCT00533429|141725090|SUPERIORITY_OR_OTHER_LEGACY|||||||0.462||||||95% confidence interval based on normal approximation to the binomial distribution. P-value (2-tailed) calculation based on unadjusted, normal-distribution approximation for the difference in rates.|Fisher Exact|||||||0.462
71109964|NCT00533429|141725091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.492||||||P-value (two-tailed) was calculated based on the un-stratified log-rank test.|Log Rank|||||||0.492
71109965|NCT01824290|141725113|SUPERIORITY||Mean Difference (Final Values)|23.88|STANDARD_ERROR_OF_MEAN|29.114|||TWO_SIDED|80.0|-14.25|62.0||||||||62.00|-14.25|
70852325|NCT00966875|141193426|SUPERIORITY_OR_OTHER|||||||0.004||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.004
71060671|NCT05724589|141628578|SUPERIORITY|The statistical analysis in this study to assess changes in Transepidermal Water Loss (TEWL) after serum application involved a repeated measures analysis of variance (ANOVA). This approach allows for the examination of differences in TEWL across multiple time points (baseline, 8 weeks, 12 weeks, and 16 weeks) within the same individuals. The use of repeated measures ANOVA accounts for the correlated nature of the data, as multiple measurements are obtained from each participant over time.|Mean Difference (Final Values)|-3.656||||0.096|TWO_SIDED|||||A repeated measures ANOVA was used to assess changes in hydration over time. The mean difference between baseline and 16 weeks was -3.656 (arbitrary units). Results are presented in the corresponding outcome measure table.|ANOVA|||||||0.096
71060672|NCT05724589|141628579|SUPERIORITY|The chosen test was designed to assess whether application of the intervention resulted in any statistically significant differences over time in the primary outcome measure, assuming superiority.|Mean Difference (Final Values)|-0.043||||0.169|TWO_SIDED|||||The pre-specified significance threshold was set at p \< 0.05. No adjustments for multiple comparisons were applied.|ANOVA|Sphericity tested; Greenhouse-Geisser applied if needed. Repeated measures ANOVA accounted for within-subject correlations.|The estimation parameter reflects the change in the R2 elasticity measure from baseline to 16 weeks. The direction of change is based on the final minus baseline value, with baseline serving as the reference point.|The statistical analysis utilized repeated measures ANOVA to evaluate changes in facial skin elasticity (R2 parameter) across multiple time points (Baseline, Week 8, Week 12, and Week 16) within the same participants. This approach accounts for the correlation of repeated measures over time.||||0.169
71060673|NCT05724589|141628580|SUPERIORITY|This study aimed to evaluate changes in wrinkle scores using a 4-grade percentage wrinkle improvement scale across different time points, including baseline, 8 weeks, 12 weeks, and 16 weeks|Mean Difference (Final Values)|1.0||||1|TWO_SIDED||||||ANOVA||The Mean Difference represents the change in wrinkle scores from baseline (Day 0) to follow-up at Week 8, Week 12, or Week 16. For example, a Mean Difference of 1.0 indicates a 1-point improvement from baseline to Week 16 (Week 16 - baseline score).|||||1.000
71060674|NCT05724589|141628581|SUPERIORITY|Repeated measures ANOVA was used to detect any change in facial melanin levels due to the intervention.|Mean Difference (Final Values)|-3.458||||1|TWO_SIDED|||||The p-value indicates no statistically significant change in facial melanin index over time. The p-value was not adjusted for multiple comparisons. Statistical significance was pre-specified at p \< 0.05.|ANOVA|Sphericity assumptions were checked and addressed as needed (e.g., Greenhouse-Geisser correction).|The estimation parameter reflects the mean change in melanin index from baseline to week 16. Baseline was used as the reference point in the analysis.|The statistical analysis assessed changes in facial melanin index after serum application using repeated measures ANOVA. This method evaluated differences across multiple time points (Baseline, Week 8, Week 12, and Week 16) within the same participants, accounting for the correlated nature of repeated measures.||||1.000
71060675|NCT05724589|141628582|SUPERIORITY|A descriptive analysis was performed. No hypothesis testing or power calculation was conducted for this outcome.|percentage of participants at week 16|44.0||||1|TWO_SIDED|||||The p-value reflects descriptive analysis of SGAIS improvement scores; no statistical testing for significance was conducted.|Descriptive|The evaluation involved categorical SGAIS ratings assigned by two independent dermatologists.|This estimate reflects the proportion of participants rated as showing mild improvement on the SGAIS at Week 16, as detailed in the tabular data.|Improvement in facial appearance was assessed using the Subject Global Aesthetic Improvement Scale (SGAIS), rated independently by two board-certified dermatologists at multiple time points (8, 12, and 16 weeks).||||1.000
71060676|NCT05724589|141628583|SUPERIORITY|Descriptive summary statistics were used to report satisfaction at multiple time points. No inferential testing was performed.|percentage of participants at week 16|75.0|||||TWO_SIDED||||||Descriptive|No formal statistical hypothesis testing was performed.|The estimated percentage reflects participants who reported a satisfaction score of 2 or 3 at week 16.|"Satisfaction was assessed at weeks 8, 12, and 16 using a quartile scale:~0 = Unsatisfied, 1 = Slightly satisfied, 2 = Satisfied, 3 = Very satisfied. One participant was lost to follow-up after week 12."||||
71060677|NCT05724589|141628584|SUPERIORITY|This was a descriptive safety analysis. No inferential hypothesis testing was conducted.|Percentage adverse events by week 16|0.0|||||TWO_SIDED||||||Descriptive|No formal statistical test was conducted.|Descriptive summaries of adverse event incidence are reported in the results tables.|The analysis population includes 28 participants. One subject was lost to follow-up at week 12. Adverse events were assessed through video calls at weeks 2 and 4, and in-person visits at 2, 3, and 4 months.||||
71060678|NCT02329015|141628585|SUPERIORITY_OR_OTHER||Slope|0.58||||0.54|TWO_SIDED|95.0|-1.25|2.41|||Regression, Logistic|||Model 1: An intent to treat analyses was performed determining effect of group assignment on academic performance while controlling for previous year GPA.||2.41|-1.25|0.54
71060679|NCT02329015|141628585|SUPERIORITY_OR_OTHER||Slope|1.67||||0.08|TWO_SIDED|95.0|-0.21|3.55|||Regression, Linear|||Model 2: As active participation between groups was significantly different a second intent to treat analysis was performed which added to Model 1 (controlling for previous year GPA) by controlling for active participation.||3.55|-0.21|0.08
71060680|NCT02329015|141628585|SUPERIORITY_OR_OTHER||Slope|2.7||||0.009|TWO_SIDED|95.0|0.69|4.71|||Regression, Linear|||Model 3: Per Protocol Analysis: it was hypothesized that any benefit of yoga education would only accrue if the student was assigned to yoga classes and actively participated in the class. A third Model was fit with an interaction term for class assignment and class participation.||4.71|0.69|0.009
71060681|NCT02329015|141628586|SUPERIORITY_OR_OTHER|||||||0.301|||||||Regression, Linear|||Analysis of the Voluntary subscale of the Response to Stress Questionnaire||||0.301
71060682|NCT04331808|141628593|SUPERIORITY||Median posterior absolute risk differenc|-9.0|||||TWO_SIDED|90.0|-21.0|3.1||Posterior probability|Bayesian analysis|Adjusted for age and centre|% Confidence Interval is % Credibility interval here|||3.1|-21.0|
71060683|NCT04331808|141628594|SUPERIORITY||Median posterior Hazard Ratio|0.58|||||TWO_SIDED|90.0|0.33|1.0||Posterior probability|Bayesian analysis|HR adjusted for age and centre|% Confidence interval is % Credible Interval here|||1.00|0.33|
70852326|NCT00966875|141193426|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
71109966|NCT02967679|141725125|OTHER||Mean Difference (Net)|1.67|STANDARD_DEVIATION|11.45||0.7615|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.7615
71109967|NCT02967679|141725126|OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|8.89||0.5995|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.5995
71109968|NCT02967679|141725127|OTHER||Mean Difference (Net)|4.8|STANDARD_DEVIATION|8.4||0.1641|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.1641
71109969|NCT02967679|141725128|OTHER||Mean Difference (Net)|8.5|STANDARD_DEVIATION|16.5||0.0353|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0353
70936620|NCT00824850|141373412|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 4: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
70936621|NCT00824850|141373412|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
70936622|NCT00824850|141373412|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
70936623|NCT00824850|141373412|SUPERIORITY_OR_OTHER||difference in proportions|2.9|||||TWO_SIDED|95.0|-6.9|14.9||||||7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||14.9|-6.9|
71060684|NCT04331808|141628595|SUPERIORITY||Median posterior absolute risk differenc|1.7|||||TWO_SIDED|90.0|-13.6|17.1||Posterior probability|Bayesian analysis|Adjusted for age and centre|% Confidence Interval is % Credible Interval here Results are presented as the proportion not improved, so that an effective treatment would be associated with a decrease in proportion.|||17.1|-13.6|
71060685|NCT04331808|141628596|SUPERIORITY||Median posterior Hazard Ratio|1.19|||||TWO_SIDED|90.0|0.71|2.04||Posterior probability|Bayesian analysis|HR adjusted for age and centre|% Confidence interval is % Credible Interval here|||2.04|0.71|
70936624|NCT00824850|141373412|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
70936625|NCT00824850|141373412|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
70936626|NCT00824850|141373412|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
71060686|NCT04331808|141628597|SUPERIORITY||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.4|3.55|||Regression, Cox|adjusted for age and sex||Day 14||3.55|0.40|
70936627|NCT00824850|141373412|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
70936628|NCT00824850|141373412|SUPERIORITY_OR_OTHER||difference in proportions|-2.2|||||TWO_SIDED|95.0|-15.7|10.9||||||Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.9|-15.7|
71060687|NCT04331808|141628597|SUPERIORITY||Cox Proportional Hazard|0.92|||||TWO_SIDED|95.0|0.33|2.53|||Regression, Cox|adjusted for age and centre||Day 28||2.53|0.33|
71060688|NCT04331808|141628597|SUPERIORITY||Cox Proportional Hazard|0.64|||||TWO_SIDED|95.0|0.25|1.65|||Regression, Cox|adjusted for age and centre||Day 90||1.65|0.25|
71060689|NCT04331808|141628597|SUPERIORITY||Hazard Ratio (HR)|0.37|||||TWO_SIDED|95.0|0.12|1.15|||Regression, Cox|adjusted for age and centre||Day 14||1.15|0.12|
71060690|NCT04331808|141628597|SUPERIORITY||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.32|1.47|||Regression, Cox|adjusted for age and centre||Day 28||1.47|0.32|
70936629|NCT00824850|141373412|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
71109970|NCT02967679|141725129|OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|1.4||0.2642|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.2642
71109971|NCT02967679|141725130|OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|1.2||0.1777|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.1777
71109972|NCT02967679|141725131|OTHER||Mean Difference (Net)|4.5|STANDARD_DEVIATION|8.2||0.0371|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0371
71109973|NCT02967679|141725132|OTHER||Mean Difference (Net)|-2.2|STANDARD_DEVIATION|2.9||0.0142|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0142
71109974|NCT02967679|141725134|OTHER||Mean Difference (Net)|0.111|STANDARD_DEVIATION|0.201||0.1055|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.1055
71109975|NCT02967679|141725135|OTHER||Mean Difference (Net)|9.84|STANDARD_DEVIATION|28.16||0.213|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.2130
71109976|NCT02967679|141725136|OTHER||Mean Difference (Net)|0.068|STANDARD_DEVIATION|0.112||0.0393|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0393
71109977|NCT02967679|141725137|OTHER||Mean Difference (Net)|-5.905|STANDARD_DEVIATION|6.283||0.0004|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0004
71109978|NCT02967679|141725138|OTHER||Mean Difference (Net)|-4.28|STANDARD_DEVIATION|32.21||0.3303|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.3303
71109979|NCT02967679|141725139|OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.092||0.9229|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.9229
71109980|NCT00600067|141725149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.17||0.0381|TWO_SIDED|95.0|-0.69|-0.02|||ANCOVA|||||-0.02|-0.69|0.0381
71109981|NCT00600067|141725150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|1.26|<|0.0001|TWO_SIDED|95.0|-9.18|-4.21|||ANCOVA|||||-4.21|-9.18|<0.0001
71109982|NCT02030821|141725182|OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
71109983|NCT02030821|141725183|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
71109984|NCT02030821|141725184|OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
71109985|NCT02030821|141725185|OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
70936630|NCT00824850|141373412|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
70936631|NCT00824850|141373412|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
70936632|NCT00824850|141373412|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
71060691|NCT04331808|141628597|SUPERIORITY||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.3|1.49|||Regression, Cox|adjusted for age and centre||Day 90||1.49|0.30|
71060692|NCT04331808|141628598|SUPERIORITY||Median posterior OR|0.6|||||TWO_SIDED|95.0|0.27|1.28|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre|% Confidence Interval is % Credible Interval here|Day 4||1.28|0.27|
71060693|NCT04331808|141628598|SUPERIORITY||Median posterior OR|0.86|||||TWO_SIDED|95.0|0.43|1.71|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre||Day 7|% Confidence Interval is % Credible Interval here|1.71|0.43|
71060694|NCT04331808|141628598|SUPERIORITY||Median posterior OR|0.76|||||TWO_SIDED|95.0|0.4|1.42|||Proportionnal odds model|Bayesian analysis. Adjusted for age and sex|% Confidence Interval is % Credible Interval here|Day 14||1.42|0.40|
71060695|NCT04331808|141628598|SUPERIORITY||Median posterior OR|0.85|||||TWO_SIDED|95.0|0.39|1.82|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre||Day 4|% Confidence Interval is % Credible Interval here|1.82|0.39|
71060696|NCT04331808|141628598|SUPERIORITY||Median posterior OR|0.69|||||TWO_SIDED|95.0|0.32|1.47|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre|% Confidence Interval is % Credible Interval here|Day 7||1.47|0.32|
71060697|NCT04331808|141628598|SUPERIORITY||Median posterior OR|0.68|||||TWO_SIDED|95.0|0.32|1.43|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre|% Confidence Interval is % Credible Interval here|Day 14||1.43|0.32|
71060698|NCT04331808|141628599|SUPERIORITY||Mean Difference (Net)|-2.5|||||TWO_SIDED|95.0|-6.9|1.7||adjusted on age and centre||||||1.7|-6.9|
71060699|NCT04331808|141628600|SUPERIORITY||Hazard Ratio (HR)|1.41|||||TWO_SIDED|95.0|0.98|2.01|||Fine-Gray model|adjusted for age and centre||Day 28||2.01|0.98|
71060700|NCT04331808|141628600|SUPERIORITY||Hazard Ratio (HR)|1.44|||||TWO_SIDED|95.0|0.82|2.52|||Fine-Gray model|||Day 28||2.52|0.82|
71060701|NCT04331808|141628600|SUPERIORITY||Hazard Ratio (HR)|1.28|||||TWO_SIDED|95.0|0.8|2.03|||Fine-Gray model|adjusted on age and centre||Day 90||2.03|0.80|
71060702|NCT04331808|141628601|SUPERIORITY||Hazard Ratio (HR)|1.52|||||TWO_SIDED|95.0|1.02|2.27|||Fine-Gray model|adjusted on age and centre||Day 28||2.27|1.02|
70936633|NCT00824850|141373413|SUPERIORITY_OR_OTHER||difference in proportions|9.0|||||TWO_SIDED|95.0|-5.6|25.5||||||7vPnC serotype 4: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||25.5|-5.6|
70936634|NCT00824850|141373413|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
70936635|NCT00824850|141373413|SUPERIORITY_OR_OTHER||difference in proportions|2.9|||||TWO_SIDED|95.0|-6.9|14.9||||||7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||14.9|-6.9|
71060703|NCT04331808|141628601|SUPERIORITY||Hazard Ratio (HR)|1.45|||||TWO_SIDED|95.0|0.8|2.63|||Fine-Gray model|adjusted for age and centre||Day 28||2.63|0.80|
71060704|NCT04331808|141628601|SUPERIORITY||Hazard Ratio (HR)|1.35|||||TWO_SIDED|95.0|0.84|2.17|||Fine-Gray model|adjusted for age and centre||Day 90||2.17|0.84|
71060705|NCT04331808|141628602|SUPERIORITY||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.73|1.81|||Fine-Gray model|adjusted on age and centre||Day 28||1.81|0.73|
71060706|NCT04331808|141628602|SUPERIORITY||Hazard Ratio (HR)|1.28|||||TWO_SIDED|95.0|0.73|2.24|||Fine-Gray model|adjusted on age and centre||Day 90||2.24|0.73|
71060707|NCT02189837|141628604|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|88.76|STANDARD_ERROR_OF_MEAN|36.67||0.018|TWO_SIDED|95.0|15.73|161.8|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||The superiority of evolocumab monotherapy to placebo was tested using a 2-sided p-value at a significance level of 0.05.||161.80|15.73|0.018
71060708|NCT02189837|141628604|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|236.35|STANDARD_ERROR_OF_MEAN|36.32|<|0.001|TWO_SIDED|95.0|164.02|308.69|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||The treatment effect of evolocumab plus atorvastatin compared with placebo plus atorvastatin was estimated and a nominal p-value is provided.||308.69|164.02|<0.001
71060709|NCT02189837|141628604|SUPERIORITY_OR_OTHER||Treatment Effect|147.59|STANDARD_ERROR_OF_MEAN|51.61||0.005|TWO_SIDED|95.0|44.8|250.38|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||To assess whether the treatment effect of evolocumab compared with placebo depended on being administered alone or combined with atorvastatin, the interaction was tested, i.e., the difference between the treatment difference versus the respective placebo group for the evolocumab+atorvastatin group and the evolocumab group was calculated.||250.38|44.80|0.005
70936636|NCT00824850|141373413|SUPERIORITY_OR_OTHER||difference in proportions|5.7|||||TWO_SIDED|95.0|-4.2|19.2||||||7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||19.2|-4.2|
70936637|NCT00824850|141373413|SUPERIORITY_OR_OTHER||difference in proportions|3.1|||||TWO_SIDED|95.0|-9.3|17.0||||||7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||17.0|-9.3|
71060710|NCT02189837|141628605|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-57.14|STANDARD_ERROR_OF_MEAN|4.4|<|0.001||95.0|-65.91|-48.38|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||-48.38|-65.91|<0.001
71060711|NCT02189837|141628605|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-37.95|STANDARD_ERROR_OF_MEAN|4.31|<|0.001|TWO_SIDED|95.0|-46.55|-29.34|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||-29.34|-46.55|<0.001
71060712|NCT02189837|141628605|SUPERIORITY_OR_OTHER||Treatment Effect|19.2|STANDARD_ERROR_OF_MEAN|6.15||0.003|TWO_SIDED|95.0|6.93|31.47|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||31.47|6.93|0.003
71060713|NCT02189837|141628606|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-16.65|STANDARD_ERROR_OF_MEAN|10.41||0.11|TWO_SIDED|95.0|-37.37|4.08|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||4.08|-37.37|0.11
71060714|NCT02189837|141628606|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-32.66|STANDARD_ERROR_OF_MEAN|10.31||0.002|TWO_SIDED|95.0|-53.19|-12.13|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||-12.13|-53.19|0.002
71060715|NCT02189837|141628606|SUPERIORITY_OR_OTHER||Treatment Effect|-16.01|STANDARD_ERROR_OF_MEAN|14.65||0.28|TWO_SIDED|95.0|-45.18|13.16|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||13.16|-45.18|0.28
71060716|NCT02189837|141628607|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-2.12|STANDARD_ERROR_OF_MEAN|13.4||0.87|TWO_SIDED|95.0|-28.94|24.7|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||The superiority of evolocumab monotherapy to placebo was tested using a 2-sided p-value at a significance level of 0.05.||24.70|-28.94|0.87
71060717|NCT02189837|141628607|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|39.06|STANDARD_ERROR_OF_MEAN|12.76||0.003|TWO_SIDED|95.0|13.52|64.59|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||The treatment effect of evolocumab plus atorvastatin compared with placebo plus atorvastatin was estimated and a nominal p-value is provided.||64.59|13.52|0.003
71060718|NCT02189837|141628607|SUPERIORITY_OR_OTHER||Treatment Effect|41.18|STANDARD_ERROR_OF_MEAN|18.5||0.03|TWO_SIDED|95.0|4.15|78.2|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||To assess whether the treatment effect of evolocumab compared with placebo depended on being administered alone or combined with atorvastatin, the interaction was tested, i.e., the difference between the treatment difference versus the respective placebo group for the evolocumab+atorvastatin group and the evolocumab group was calculated.||78.20|4.15|0.030
71060719|NCT02189837|141628608|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-39.43|STANDARD_ERROR_OF_MEAN|11.6||0.001|TWO_SIDED|95.0|-62.66|-16.21|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||-16.21|-62.66|0.001
71060720|NCT02189837|141628608|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|23.28|STANDARD_ERROR_OF_MEAN|11.05||0.039|TWO_SIDED|95.0|1.16|45.4|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||45.40|1.16|0.039
71060721|NCT02189837|141628608|SUPERIORITY_OR_OTHER||Treatment Effect|62.72|STANDARD_ERROR_OF_MEAN|16.02|<|0.001|TWO_SIDED|95.0|30.65|94.79|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||94.79|30.65|<0.001
70936638|NCT00824850|141373413|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
71060722|NCT00619060|141628619|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|95.0|||||Binomial|||||||0.01
71060723|NCT02443740|141628630|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio.|39.58|||||TWO_SIDED|90.0|30.14|51.99|||||Values have been back-transformed from the log scale.|||51.99|30.14|
70936639|NCT00824850|141373413|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
70936640|NCT00824850|141373413|SUPERIORITY_OR_OTHER||difference in proportions|2.9|||||TWO_SIDED|95.0|-6.9|14.9||||||Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||14.9|-6.9|
71060724|NCT02443740|141628631|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio|80.6|||||TWO_SIDED|90.0|59.74|108.75|||||Values have been back-transformed from the log scale.|||108.75|59.74|
71060725|NCT02443740|141628632|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio|80.12|||||TWO_SIDED|90.0|58.92|108.94|||||Values have been back-transformed from the log scale.|||108.94|58.92|
71060726|NCT02443740|141628637|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio|65.58|||||TWO_SIDED|90.0|62.18|69.16|||||Values have been back-transformed from the log scale.|||69.16|62.18|
71060727|NCT02443740|141628638|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio|68.62|||||TWO_SIDED|90.0|63.27|74.41|||||Values have been back-transformed from the log scale.|||74.41|63.27|
71060728|NCT02443740|141628639|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio.|29.76|||||TWO_SIDED|90.0|24.17|36.64|||||Values have been back-transformed from the log scale.|||36.64|24.17|
70852327|NCT00966875|141193426|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
70936641|NCT00824850|141373413|SUPERIORITY_OR_OTHER||difference in proportions|6.9|||||TWO_SIDED|95.0|-7.4|23.4||||||Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||23.4|-7.4|
70936642|NCT00824850|141373413|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
70936643|NCT00824850|141373413|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
70936644|NCT00824850|141373413|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
70936645|NCT00824850|141373413|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
70936646|NCT00824850|141373414|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.2|10.9||||||7vPnC serotype 4: difference in proportions, \[7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided confidence interval.||10.9|-10.2|
70936647|NCT00824850|141373414|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
70936648|NCT00824850|141373414|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
71060729|NCT02443740|141628641|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio|16.71|||||TWO_SIDED|90.0|15.35|18.18|||||Values were back-transformed from the log scale.|||18.18|15.35|
71060730|NCT02443740|141628643|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio|15.21|||||TWO_SIDED|90.0|13.29|17.42|||||Values were back-transformed from the log scale.|||17.42|13.29|
71060731|NCT02348112|141628652|NON_INFERIORITY|The number and proportion of subjects experiencing a 50% or greater reduction in pad weight at 6 months were compared, and non-inferiority assessed using a normal approximation test (Z-test) for a difference in binomial proportion. Non-inferiority was considered achieved if the 95% confidence interval for the difference in proportions (Comparator - Altis) was less than 0.15.|Difference in Proportions|-0.054||||0.013|TWO_SIDED|95.0|-0.139|0.031|||Normal approximation test (Z-test)|||||0.031|-0.139|0.013
71060732|NCT02348112|141628653|NON_INFERIORITY|The number and proportion of subjects experiencing device- and/or procedure-related serious adverse events were tabulated for each study group. Non-inferiority through 36 months was calculated using a normal approximation test (Z-test) for a difference in binomial proportion. Non-inferiority was considered achieved if the lower limit of the 95% confidence interval for the difference in proportions (Comparator - Altis) is greater than -0.10 in the mITT analysis population.|Difference in Proportions|0.013|||<|0.0001|TWO_SIDED|95.0|-0.023|0.048|||Normal approximation test (Z-test)|||||0.048|-0.023|<0.0001
71060733|NCT03741400|141628654|OTHER|||||||0.88||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis of change in total seconds||||0.88
71060734|NCT03741400|141628654|OTHER|||||||0.99||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis of change in fine motor skill assessment||||0.99
70936649|NCT00824850|141373414|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
70936650|NCT00824850|141373414|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
70936651|NCT00824850|141373414|SUPERIORITY_OR_OTHER||difference in proportions|-2.6|||||TWO_SIDED|95.0|-13.9|8.0||||||7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||8.0|-13.9|
70936652|NCT00824850|141373414|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
70936653|NCT00824850|141373414|SUPERIORITY_OR_OTHER||difference in proportions|2.9|||||TWO_SIDED|95.0|-6.7|15.3||||||Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||15.3|-6.7|
70936654|NCT00824850|141373414|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
70936655|NCT00824850|141373414|SUPERIORITY_OR_OTHER||difference in proportions|0.9|||||TWO_SIDED|95.0|-15.0|17.6||||||Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||17.6|-15.0|
70936656|NCT00824850|141373414|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
71060735|NCT03741400|141628654|OTHER|||||||0.8||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis of change in gross motor skills assessment||||0.80
71060736|NCT03741400|141628655|OTHER|||||||0.61||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||||||0.61
70852328|NCT00966875|141193426|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
71060737|NCT03741400|141628656|OTHER|||||||0.47||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis of change in total seconds||||0.47
71060738|NCT03741400|141628656|OTHER|||||||0.55||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis of change in fine motor skill assessment||||0.55
70852329|NCT00966875|141193426|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
71060739|NCT03741400|141628656|OTHER|||||||0.38||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis of change in gross motor skills assessment||||0.38
71060740|NCT03741400|141628657|OTHER|||||||0.24||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||||||0.24
71060741|NCT03741400|141628658|OTHER|||||||0.18||||||A priori threshold for statistical significance, 0.05|Mann-Whitney U test|||||||0.18
71060742|NCT03741400|141628659|OTHER|||||||0.926||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis at week 12||||0.926
71060743|NCT03741400|141628659|OTHER|||||||0.828||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis at week 24||||0.828
71060744|NCT03714828|141628668|OTHER||Overall Response Rate|100.0||||0.0005|ONE_SIDED|95.0|76.2||||One-sample binomial test|One-sample binomial test versus null hypothesis value of 0.50.|||||76.2|0.0005
71060745|NCT03714828|141628670|OTHER|Descriptive statistics|Mean|48.7|STANDARD_DEVIATION|29.2|||TWO_SIDED|||||||||||||
71060746|NCT03714828|141628672|OTHER|Binomial proportion of TILs|Percentage|83.3|||||TWO_SIDED|||||||||||||
71060747|NCT03714828|141628675|OTHER|Counts of TILs|Percentage|100.0|||||TWO_SIDED|||||||||||||
71060748|NCT03714828|141628676|OTHER||Percentage|100.0|||||TWO_SIDED|||||||||||||
71060749|NCT01998841|141628680|SUPERIORITY||Difference in Annualized Rate of Change|0.33|STANDARD_ERROR_OF_MEAN|0.41||0.43|TWO_SIDED|95.0|-0.48|1.13|||RCRM|||Analysis was based on random coefficient regression model (RCRM) using unstructured covariance matrix: API Composite Endpoint=Treatment \* Analysis Year + interactive voice or Web-based response system (IxRS) defined Age Group + IxRS defined Education History + IxRS defined apolipoprotein E4 (APOE4) Carrier Status + IxRS defined CDR Global Score.||1.13|-0.48|0.43
71060750|NCT01998841|141628681|SUPERIORITY||Difference in Annualized Rate of Change|0.008|STANDARD_ERROR_OF_MEAN|0.006||0.16|TWO_SIDED|95.0|-0.003|0.02|||RCRM|||Analysis was based on RCRM using unstructured covariance matrix: FCSRT Cueing Index = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||0.02|-0.003|0.16
71060751|NCT01998841|141628682|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.48|TWO_SIDED|95.0|0.41|1.52|||Stratified Log Rank||Hazard ratios were estimated by Cox regression|Stratification factors used: Age Group, Education History, APOE4 Carrier Status, Clinical Dementia Rating (CDR) Global Score.||1.52|0.41|0.48
71060752|NCT01998841|141628683|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.76|TWO_SIDED|95.0|0.53|1.59|||Stratified Log Rank||Hazard ratios were estimated by Cox regression.|Stratification factors used: Age Group, Education History, APOE4 Carrier Status.||1.59|0.53|0.76
70852330|NCT00966875|141193426|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
71060753|NCT01998841|141628684|SUPERIORITY||Difference in Annualized Rate of Change|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.64|TWO_SIDED|95.0|-0.15|0.09|||RCRM|||Analysis was based on RCRM using unstructured covariance matrix: CDR-SB = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||0.09|-0.15|0.64
71060754|NCT01998841|141628685|SUPERIORITY||Difference in Annualized Rate of Change|0.18|STANDARD_ERROR_OF_MEAN|0.29||0.55|TWO_SIDED|95.0|-0.4|0.75|||RCRM|||Analysis was based on RCRM using unstructured covariance matrix: RBANS Total Score = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||0.75|-0.40|0.55
71060755|NCT01998841|141628686|SUPERIORITY||Difference in Annualized Rate of Change|-0.0006|STANDARD_ERROR_OF_MEAN|0.002||0.69|TWO_SIDED|95.0|-0.0037|0.0024|||RCRM|||Analysis was based on RCRM using unstructured covariance matrix: PET SUVR = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||0.0024|-0.0037|0.69
71060756|NCT01998841|141628687|SUPERIORITY||Difference in Annualized Rate of Change|0.003|STANDARD_ERROR_OF_MEAN|0.002||0.25|TWO_SIDED|95.0|-0.002|0.007|||RCRM|||Analysis was based on RCRM using unstructured covariance matrix: FDG-PET = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||0.007|-0.002|0.25
71060757|NCT01998841|141628688|SUPERIORITY||Difference in Annualized Rate of Change|107.78|STANDARD_ERROR_OF_MEAN|92.28||0.25|TWO_SIDED|95.0|-74.5|290.05|||RCRM|||Whole Brain: Analysis was based on RCRM using unstructured covariance matrix: MRI Whole Brain (Derived) = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||290.05|-74.5|0.25
71060758|NCT01998841|141628688|SUPERIORITY||Difference in Annualized Rate of Change|9.6|STANDARD_ERROR_OF_MEAN|17.39||0.58|TWO_SIDED|95.0|-24.74|43.94|||RCRM|||Bilateral Hippocampus: Analysis was based on RCRM using unstructured covariance matrix: MRI Bilateral Hippocampus = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||43.94|-24.74|0.58
71060759|NCT01998841|141628688|SUPERIORITY||Difference in Annualized Rate of Change|19.92|STANDARD_ERROR_OF_MEAN|213.08||0.93|TWO_SIDED|95.0|-400.78|440.62|||RCRM|||Ventricles: Analysis was based on RCRM using unstructured covariance matrix: MRI Ventricles = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||440.62|-400.78|0.93
70852331|NCT00966875|141193428|SUPERIORITY_OR_OTHER|||||||0.227|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.227
70852332|NCT00966875|141193428|SUPERIORITY_OR_OTHER|||||||0.306|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.306
70852333|NCT00966875|141193428|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.001
71060760|NCT01998841|141628689|SUPERIORITY||Difference in Annualized Rate of Change|-1.97|STANDARD_ERROR_OF_MEAN|3.09||0.53|TWO_SIDED|95.0|-8.17|4.23|||RCRM|||tTau: Analysis was based on RCRM using unstructured covariance matrix: CSF tTau = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||4.23|-8.17|0.53
71060761|NCT01998841|141628689|SUPERIORITY||Difference in Annualized Rate of Change|-0.5|STANDARD_ERROR_OF_MEAN|0.46||0.28|TWO_SIDED|95.0|-1.43|0.43|||RCRM|||pTau: Analysis was based on RCRM using unstructured covariance matrix: CSF pTau = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||0.43|-1.43|0.28
71109986|NCT03192137|141725187|SUPERIORITY|Statistical hypotheses testing for the primary efficacy endpoint was two-sided and performed using a significance (alpha) level of 0.05.||||||0.0005||||||P-values were from a Chi-Square test (with continuity correction) of differences between treatments in the proportion of participants with anterior chamber cells Grade 0 who did not receive rescue medication versus all other grades combined.|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||||||0.0005
71109987|NCT03192137|141725188|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|3.217|||<|0.0001|TWO_SIDED|95.0|1.823|5.675||P-values were from a Chi-Square test (with continuity correction).|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 1||5.675|1.823|<0.0001
71109988|NCT03192137|141725188|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|4.337|||<|0.0001|TWO_SIDED|95.0|2.305|8.161||P-values were from a Chi-Square test (with continuity correction).|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 8||8.161|2.305|<0.0001
71109989|NCT03192137|141725188|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|4.12|||<|0.0001|TWO_SIDED|95.0|2.113|8.033||P-values were from a Chi-Square test (with continuity correction).|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 15||8.033|2.113|<0.0001
71109990|NCT03192137|141725188|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|2.58||||0.0043|TWO_SIDED|95.0|1.38|4.822||P-values were from a Chi-Square test (with continuity correction).|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 18||4.822|1.380|0.0043
70852334|NCT00966875|141193428|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.070
70852335|NCT00966875|141193428|SUPERIORITY_OR_OTHER|||||||0.058|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.058
71060762|NCT01998841|141628697|SUPERIORITY||Difference in Annualized Rate of Change|7522.55|STANDARD_ERROR_OF_MEAN|313.17|<|0.0001|TWO_SIDED|95.0|6903.44|8141.65|||RCRM|||Aβ1-40: Analysis was based on RCRM using unstructured covariance matrix: APlasma Amyloid Beta 1-40 =Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||8141.65|6903.44|<0.0001
70852336|NCT00966875|141193428|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.033
71109991|NCT03192137|141725188|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|3.277||||0.0005|TWO_SIDED|95.0|1.695|6.335||P-values were from a Chi-Square test (with continuity correction).|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 29||6.335|1.695|0.0005
71109992|NCT02737501|141725230|SUPERIORITY||Hazard Ratio (HR)|0.481|||<|0.0001|TWO_SIDED|95.0|0.35|0.66||P-values are from a log-rank test stratified by randomization stratification factors (current; presence of intracranial central nervous system (iCNS) metastases at baseline and prior chemotherapy for locally advanced or metastatic disease).|Log Rank||The hazard ratio was obtained using a Cox proportional hazards model with randomization stratification factors (current) as covariates.|||0.66|0.35|<0.0001
70852337|NCT00966875|141193428|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.047
70852338|NCT00966875|141193428|SUPERIORITY_OR_OTHER|||||||0.191|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.191
70852339|NCT00966875|141193428|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.019
70852340|NCT00966875|141193428|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.013
70852341|NCT00966875|141193428|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.017
71060763|NCT01998841|141628697|SUPERIORITY||Difference in Annualized Rate of Change|556.03|STANDARD_ERROR_OF_MEAN|23.98|<|0.0001|TWO_SIDED|95.0|508.63|603.44|||RCRM|||Aβ1-42: Analysis was based on RCRM using unstructured covariance matrix: Plasma Amyloid Peptid Beta 42 =Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||603.44|508.63|<0.0001
71060764|NCT02854527|141628766|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R1) (%)|96.39|STANDARD_DEVIATION|19.4|||TWO_SIDED|90.0|88.22|105.33|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted gMean ratio (T/R1) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the first primary outcome measure of treatment R1.||105.33|88.22|
71060765|NCT02854527|141628767|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R1) (%)|93.17|STANDARD_DEVIATION|24.1|||TWO_SIDED|90.0|83.49|103.97|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted gMean ratio (T/R1) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the second primary outcome measure of treatment R1.||103.97|83.49|
71060766|NCT02854527|141628768|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R2) (%)|102.62|STANDARD_DEVIATION|20.4|||TWO_SIDED|90.0|93.82|112.25|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R2 were back transformed to original scale to get adjusted gMean ratio (T/R2) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the first primary outcome measure of treatment R2.||112.25|93.82|
71060767|NCT02854527|141628769|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R2) (%)|103.96|STANDARD_DEVIATION|24.0|||TWO_SIDED|90.0|93.6|115.46|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R2 were back transformed to original scale to get adjusted gMean ratio (T/R2) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the second primary outcome measure of treatment R2.||115.46|93.60|
71060768|NCT02854527|141628770|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R3) (%)|97.49|STANDARD_DEVIATION|9.0|||TWO_SIDED|90.0|93.54|101.61|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R3 were back transformed to original scale to get adjusted gMean ratio (T/R3) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the first primary outcome measure of treatment R3.||101.61|93.54|
71060769|NCT02854527|141628771|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R3) (%)|98.25|STANDARD_DEVIATION|14.7|||TWO_SIDED|90.0|91.85|105.09|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R3 were back transformed to original scale to get adjusted gMean ratio (T/R3) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the second primary outcome measure of treatment R3.||105.09|91.85|
71060770|NCT02854527|141628772|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R4) (%)|105.01|STANDARD_DEVIATION|18.8|||TWO_SIDED|90.0|96.39|114.4|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R4 were back transformed to original scale to get adjusted gMean ratio (T/R4) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the first primary outcome measure of treatment R4.||114.40|96.39|
71060771|NCT02854527|141628773|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R4) (%)|104.28|STANDARD_DEVIATION|20.6|||TWO_SIDED|90.0|94.95|114.53|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R4 were back transformed to original scale to get adjusted gMean ratio (T/R4) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the second primary outcome measure of treatment R4.||114.53|94.95|
70936657|NCT00824850|141373414|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
71060772|NCT02854527|141628774|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R1) (%)|96.53|STANDARD_DEVIATION|10.1|||TWO_SIDED|90.0|92.08|101.2|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted gMean ratio (T/R1) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the secondary outcome measure of treatment R1.||101.20|92.08|
71060773|NCT02854527|141628775|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R2) (%)|97.4|STANDARD_DEVIATION|9.6|||TWO_SIDED|90.0|90.87|104.41|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R2 were back transformed to original scale to get adjusted gMean ratio (T/R2) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the secondary outcome measure of treatment R2.||104.41|90.87|
71060774|NCT02854527|141628776|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R3) (%)|97.5|STANDARD_DEVIATION|8.9|||TWO_SIDED|90.0|93.58|101.58|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R3 were back transformed to original scale to get adjusted gMean ratio (T/R3) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the secondary outcome measure of treatment R3.||101.58|93.58|
70936658|NCT00824850|141373414|SUPERIORITY_OR_OTHER||difference in proportions|-2.6|||||TWO_SIDED|95.0|-13.9|7.6||||||Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||7.6|-13.9|
70936659|NCT00824850|141373415|SUPERIORITY_OR_OTHER||difference in proportions|-2.6|||||TWO_SIDED|95.0|-13.9|8.0||||||7vPnC serotype 4: difference in proportions, \[7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided confidence interval.||8.0|-13.9|
70936660|NCT00824850|141373415|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.2|10.6||||||7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.6|-10.2|
71060775|NCT02854527|141628777|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R4) (%)|107.63|STANDARD_DEVIATION|19.4|||TWO_SIDED|90.0|97.04|119.39|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R4 were back transformed to original scale to get adjusted gMean ratio (T/R4) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the secondary outcome measure of treatment R4.||119.39|97.04|
71060776|NCT02575833|141628785|NON_INFERIORITY|The non-inferiority margin was -90 seconds.|Treatment Difference|-11.0|STANDARD_ERROR_OF_MEAN|20.4|||TWO_SIDED|90.0|-44.9|22.9||||||The primary endpoint was analyzed using an analysis of variance model with terms for treatment group and randomization strata (\< 7 or ≥ 7 minutes). If the lower bound of the 90% confidence interval (CI) of the difference in change from baseline in exercise duration was above the non-inferiority margin of -90 seconds, then the hypothesis that erenumab does not decrease exercise duration would be supported.||22.9|-44.9|
71060777|NCT02575833|141628786|SUPERIORITY|The log-rank test statistic was used to compare the two treatment groups at a significance level of 0.10.|Normal score|1.55||||0.69|||||||Stratified Log Rank|Log rank test stratified by baseline total exercise time strata (\< 7 minutes or ≥ 7 minutes).|A normal score \< 0 indicates fewer than expected events for erenumab 140 mg relative to placebo and therefore a longer survival time.|||||0.69
71060778|NCT02575833|141628786|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.69|TWO_SIDED|90.0|0.73|1.69|||Cox Proportional Hazard|Adjusted by stratified baseline total exercise time strata (\< 7 or ≥ 7 minutes)|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer exercise-induced angina free survival for erenumab 140 mg relative to placebo.|||1.69|0.73|0.69
71060779|NCT02575833|141628786|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.44|TWO_SIDED|90.0|0.52|1.26|||Cox Proportional Hazard|Adjusted by continuous baseline total exercise time|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer exercise-induced angina free survival for erenumab 140 mg relative to placebo.|||1.26|0.52|0.44
70936661|NCT00824850|141373415|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
70936662|NCT00824850|141373415|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.3||||||7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.5|
70936663|NCT00824850|141373415|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
70936664|NCT00824850|141373415|SUPERIORITY_OR_OTHER||difference in proportions|-2.8|||||TWO_SIDED|95.0|-16.8|10.1||||||7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-16.8|
70852342|NCT00966875|141193428|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.026
71060780|NCT02575833|141628786|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.47|TWO_SIDED|90.0|0.52|1.28|||Cox Proportional Hazard|Adjusted by baseline total exercise time strata (\< 7 or ≥ 7 minutes), age group (\< 65, ≥ 65), and sex.|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer exercise-induced angina free survival for erenumab 140 mg relative to placebo.|||1.28|0.52|0.47
71060781|NCT02575833|141628787|SUPERIORITY|The log-rank test statistic was used to compare the two treatment groups at a significance level of 0.10.|Normal score|2.2||||0.59|||||||Stratified Log Rank|Log rank test stratified by baseline total exercise time strata (\< 7 minutes or ≥ 7 minutes).|A normal score \< 0 indicates fewer than expected events for erenumab 140 mg relative to placebo and therefore a longer survival time.|||||0.59
71060782|NCT02575833|141628787|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.59|TWO_SIDED|90.0|0.76|1.69|||Cox Proportional Hazard|Adjusted by stratified baseline total exercise time strata (\< 7 or ≥ 7 minutes)|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer exercise-induced ST-segment depression free survival for erenumab 140 mg relative to placebo.|||1.69|0.76|0.59
71060783|NCT02575833|141628787|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.75|TWO_SIDED|90.0|0.73|1.6|||Cox Proportional Hazard|Adjusted by continuous baseline total exercise time|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer exercise-induced ST-segment depression free survival for erenumab 140 mg relative to placebo.|||1.60|0.73|0.75
71060784|NCT02575833|141628787|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.39|TWO_SIDED|90.0|0.82|1.87|||Cox Proportional Hazard|Adjusted by baseline total exercise time strata (\< 7 or ≥ 7 minutes), age group (\< 65, ≥ 65), and sex.|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer exercise-induced ST-segment depression free survival for erenumab 140 mg relative to placebo.|||1.87|0.82|0.39
71060785|NCT03093259|141628788|OTHER|One-sided 10% significance level||||||0.2096|||||||Chi-squared|||||||0.2096
71060786|NCT03093259|141628789|OTHER|||||||0.1588|||||||Chi-squared|||||||0.1588
71060787|NCT03093259|141628790|OTHER|||||||0.483|||||||ANCOVA|||||||0.4830
71060788|NCT03093259|141628791|OTHER|||||||0.0742|||||||ANCOVA|||||||0.0742
71060789|NCT03093259|141628792|OTHER|||||||0.0462|||||||ANCOVA|||||||0.0462
71060790|NCT01168427|141628813|OTHER|There was no formal statistical hypothesis tested. The goal was to estimate the procedure-related complications 90 days post implant using the Kaplan-Meier method.|Rate|0.034|||||ONE_SIDED|95.0||0.1292||||||||0.1292||
71060791|NCT02456740|141628819|SUPERIORITY|The primary endpoint was tested independently for each erenumab dose at an alpha level of 0.04 for 70 mg and of 0.01 for 140 mg to maintain the type 1 error rate at an alpha level of 0.05.|LS Mean Difference|-1.4|||<|0.001|TWO_SIDED|95.0|-1.88|-0.92|||Generalized Linear Mixed Model|||The primary endpoint was analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-0.92|-1.88|< 0.001
71060792|NCT02456740|141628819|SUPERIORITY|The primary endpoint was tested independently for each erenumab dose at an alpha level of 0.04 for 70 mg and of 0.01 for 140 mg to maintain the type 1 error rate at an alpha level of 0.05.|LS Mean Difference|-1.85|||<|0.001|TWO_SIDED|95.0|-2.33|-1.37|||Generalized Linear Mixed Model|||The primary endpoint was analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-1.37|-2.33|< 0.001
71060793|NCT02456740|141628820|SUPERIORITY|If the primary endpoint was statistically significant for the erenumab 70 mg group, using a gate-keeping strategy, the first two (first tier) secondary endpoints were tested using the Hochberg method at an alpha level of 0.04.|Odds Ratio (OR)|2.13|||<|0.001|TWO_SIDED|95.0|1.52|2.98|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel test, stratified by the randomization stratification factors (region and prior/current treatment with migraine prophylactic medication).||2.98|1.52|< 0.001
71060794|NCT02456740|141628820|SUPERIORITY|If the primary endpoint was statistically significant for the erenumab 140 mg group, using a gate-keeping strategy, the first two (first tier) secondary endpoints were tested using the Hochberg method at an alpha level of 0.01.|Odds Ratio (OR)|2.81|||<|0.001|TWO_SIDED|95.0|2.01|3.94|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel test, stratified by the randomization stratification factors (region and prior/current treatment with migraine prophylactic medication).||3.94|2.01|< 0.001
71060795|NCT02456740|141628821|SUPERIORITY|If the primary endpoint was statistically significant for the erenumab 70 mg group, using a gate-keeping strategy, the first two (first tier) secondary endpoints were tested using the Hochberg method at an alpha level of 0.04.|LS Mean Difference|-0.94|||<|0.001|TWO_SIDED|95.0|-1.23|-0.64|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-0.64|-1.23|< 0.001
71060796|NCT02456740|141628821|SUPERIORITY|If the primary endpoint was statistically significant for the erenumab 140 mg group, using a gate-keeping strategy, the first two (first tier) secondary endpoints were tested using the Hochberg method at an alpha level of 0.01.|LS Mean Difference|-1.42|||<|0.001|TWO_SIDED|95.0|-1.71|-1.12|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, (stratification factors region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-1.12|-1.71|< 0.001
71109993|NCT02737501|141725231|SUPERIORITY||Odds Ratio (OR)|1.74||||0.033|TWO_SIDED|95.0|1.04|2.91|||Cochran-Mantel-Haenszel||Odds ratios and p-values were from a Cochran-Mantel-Haenszel test stratified by presence of intracranial central nervous system (iCNS) metastases at Baseline, and prior chemotherapy for locally advanced or metastatic disease (current strata).|||2.91|1.04|0.0330
71109994|NCT02737501|141725232|SUPERIORITY||Odds Ratio (OR)|13.56|||<|0.0001|TWO_SIDED|95.0|4.7|39.11|||Cochran-Mantel-Haenszel||Odds ratios and p-values were from a Cochran-Mantel-Haenszel test stratified by presence of prior chemotherapy for Locally advanced or metastatic disease at study entry (current strata).|||39.11|4.70|<0.0001
70936665|NCT00824850|141373415|SUPERIORITY_OR_OTHER||difference in proportions|3.0|||||TWO_SIDED|95.0|-9.1|16.6||||||7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||16.6|-9.1|
70936666|NCT00824850|141373415|SUPERIORITY_OR_OTHER||difference in proportions|2.9|||||TWO_SIDED|95.0|-7.1|15.0||||||Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||15.0|-7.1|
70852343|NCT00966875|141193428|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.039
70852344|NCT00966875|141193428|SUPERIORITY_OR_OTHER|||||||0.102|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.102
70936667|NCT00824850|141373415|SUPERIORITY_OR_OTHER||difference in proportions|-2.6|||||TWO_SIDED|95.0|-13.9|8.0||||||Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||8.0|-13.9|
70936668|NCT00824850|141373415|SUPERIORITY_OR_OTHER||difference in proportions|1.2|||||TWO_SIDED|95.0|-14.8|18.2||||||Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||18.2|-14.8|
71060797|NCT02456740|141628822|SUPERIORITY|If the first tier secondary endpoints were statistically significant for both erenumab doses the erenumab 140 mg group for the 2 remaining MPFID secondary endpoints was tested using the Hochberg method at a level of 0.05; If only the erenumab 70 mg group or 140 mg group showed statistical significance for the first tier secondary endpoints then the erenumab 140 group for the 2 remaining MPFID secondary endpoints was tested for significance at a level of either 0.04 or 0.01 respectively.|LS Mean Difference|-2.43|||<|0.001|TWO_SIDED|95.0|-3.51|-1.35|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-1.35|-3.51|< 0.001
71060798|NCT02456740|141628822|SUPERIORITY|If the erenumab 140 mg group for both remaining MPFID secondary endpoints were statistically significant, then the erenumab 70 mg group for the two remaining MPFID secondary endpoints was tested for significance using the Hochberg method with the same alpha level carried over from 140 mg group.|LS Mean Difference|-1.86|||<|0.001|TWO_SIDED|95.0|-2.95|-0.77|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-0.77|-2.95|< 0.001
71060799|NCT02456740|141628823|SUPERIORITY|If the first tier secondary endpoints were statistically significant for both erenumab doses the erenumab 140 mg group for the 2 remaining MPFID secondary endpoints was tested using the Hochberg method at a level of 0.05; If only the erenumab 70 mg group or 140 mg group showed statistical significance for the first tier secondary endpoints then the erenumab 140 group for the 2 remaining MPFID secondary endpoints was tested for significance at a level of either 0.04 or 0.01 respectively.|LS Mean Difference|-2.57|||<|0.001|TWO_SIDED|95.0|-3.62|-1.51|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-1.51|-3.62|< 0.001
71060800|NCT02456740|141628823|SUPERIORITY|If the erenumab 140 mg group for both remaining MPFID secondary endpoints were statistically significant, then the erenumab 70 mg group for the two remaining MPFID secondary endpoints was tested for significance using the Hochberg method with the same alpha level carried over from 140 mg group.|LS Mean Difference|-2.22|||<|0.001|TWO_SIDED|95.0|-3.28|-1.16|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-1.16|-3.28|< 0.001
71060801|NCT04871776|141628829|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.67|1.14|||||How vs Usual Care|We used generalized estimating equations with a logit link function and binary-distributed errors, adjusting for clinic-day clustering and including clinic as an adjustment variable for all models. This analysis is otherwise unadjusted.||1.14|0.67|
71060802|NCT04871776|141628829|SUPERIORITY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.81|1.28||||||We used generalized estimating equations with a logit link function and binary-distributed errors, adjusting for clinic-day clustering and including clinic as an adjustment variable for all models. This analysis is otherwise unadjusted.||1.28|0.81|
71060803|NCT04871776|141628829|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.96|1.51||||||We used generalized estimating equations with a logit link function and binary-distributed errors, adjusting for clinic-day clustering and including clinic as an adjustment variable for all models. This analysis is otherwise unadjusted.||1.51|0.96|
71060804|NCT04871776|141628830|SUPERIORITY||Odds Ratio (OR)|0.83|||||TWO_SIDED|95.0|0.67|1.01||||||We used generalized estimating equations with a logit link function and binary-distributed errors, adjusting for clinic-day clustering and including clinic as an adjustment variable for all models. This analysis is otherwise unadjusted.||1.01|0.67|
71109995|NCT02737501|141725233|SUPERIORITY||Hazard Ratio (HR)|0.293|||<|0.0001|TWO_SIDED|95.0|0.17|0.51||P-values are from a log-rank test stratified by randomization stratification factors (current; presence of iCNS metastases at baseline and prior chemotherapy for locally advanced or metastatic disease).|Log Rank||The hazard ratio was obtained using a Cox proportional hazards model with prior chemotherapy for locally advanced or metastatic disease (current strata) as covariate.|||0.51|0.17|<0.0001
71060805|NCT04871776|141628830|SUPERIORITY||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.87|1.23||||||We used generalized estimating equations with a logit link function and binary-distributed errors, adjusting for clinic-day clustering and including clinic as an adjustment variable for all models. This analysis is otherwise unadjusted.||1.23|0.87|
71060806|NCT04871776|141628830|SUPERIORITY||Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|1.06|1.49||||||We used generalized estimating equations with a logit link function and binary-distributed errors, adjusting for clinic-day clustering and including clinic as an adjustment variable for all models. This analysis is otherwise unadjusted.||1.49|1.06|
71060807|NCT05287230|141628854|OTHER|||||||0.061||||||A priori threshold for statistical significance is p\<0.05.|ANOVA|||||||0.061
71060808|NCT01402570|141628942|SUPERIORITY_OR_OTHER||REML|0.17||||0.66|TWO_SIDED|95.0|-0.67|0.95||Time was predictor of interest, controlling for age, gender, baseline PROMIS physical functioning, and overall functional status.|Mixed Models Analysis|||Linear mixed modeling (LMM) with random effects for intercept and repeated effects for assessment period was used to analyze change over time for study outcomes. The primary predictor of interest in this study was the relationship of time to each of the outcomes to evaluate the potential effect of the intervention. Independent LMMs were used to study outcomes.||0.95|-0.67|0.66
71060809|NCT01402570|141628943|SUPERIORITY_OR_OTHER||REML|0.0||||0.44|TWO_SIDED|95.0|-0.01|0.02||Time was predictor of interest, controlling for age, gender, baseline sleep efficiency, and overall functional status.|Mixed Models Analysis|||Linear mixed modeling (LMM) with random effects for intercept and repeated effects for assessment period was used to analyze change over time for study outcomes. The primary predictor of interest in this study was the relationship of time to each of the outcomes to evaluate the potential effect of the intervention. Independent LMMs were used to study outcomes.||0.02|-0.01|0.44
71060810|NCT01402570|141628944|SUPERIORITY_OR_OTHER||REML|145.54||||0.35|TWO_SIDED|95.0|-178.93|470.02||Time was predictor of interest, controlling for age, gender, baseline steps per day, and overall functional status.|Mixed Models Analysis|||Linear mixed modeling (LMM) with random effects for intercept and repeated effects for assessment period was used to analyze change over time for study outcomes. The primary predictor of interest in this study was the relationship of time to each of the outcomes to evaluate the potential effect of the intervention. Independent LMMs were used to study outcomes.||470.02|-178.93|0.35
71060811|NCT01402570|141628945|SUPERIORITY_OR_OTHER||REML|-1.05||||0.07|TWO_SIDED|95.0|-2.21|0.1||Time was predictor of interest, controlling for age, gender, baseline fatigue, and overall functional status.|Mixed Models Analysis|||Linear mixed modeling (LMM) with random effects for intercept and repeated effects for assessment period was used to analyze change over time for study outcomes. The primary predictor of interest in this study was the relationship of time to each of the outcomes to evaluate the potential effect of the intervention. Independent LMMs were used to study outcomes.||0.10|-2.21|0.07
71060812|NCT03514459|141628946|SUPERIORITY||Prevalence ratio|1.84|||<|0.001|TWO_SIDED|95.0|1.54|2.2|||Poisson regression|Robust standard errors||||2.20|1.54|<0.001
71060813|NCT04179838|141628961|SUPERIORITY|||||||0.001||||||Corrected for multiple comparisons in piriform cortex|t-test, 1 sided|||Null hypothesis is that there was no difference in decoding accuracy between sleep-deprived and non-sleep deprived interventions. Paired t-test on decoding accuracy from both phases (sleep-deprived minus non-sleep deprived) against the null hypothesis of no difference.||||0.001
71109996|NCT02737501|141725237|SUPERIORITY||Odds Ratio (OR)|0.93||||0.822|TWO_SIDED|95.0|0.47|1.82|||Cochran-Mantel-Haenszel||Odds ratios and p-values were from a Cochran-Mantel-Haenszel test stratified by presence of iCNS metastases at Baseline, and prior chemotherapy for locally advanced or metastatic disease (current strata).|||1.82|0.47|0.8220
71060814|NCT04179838|141628962|SUPERIORITY|||||||0.021|||||||t-test, 1 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.||||0.021
71060815|NCT04179838|141628963|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.||||0.63
71060816|NCT04179838|141628964|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.||||0.08
71060817|NCT04179838|141628965|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.||||0.28
71060818|NCT04179838|141628966|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.||||0.50
71109997|NCT02737501|141725239|SUPERIORITY||Least Square Mean Difference|5.79||||0.0295|TWO_SIDED|95.0|0.58|11.0||p-values were obtained using mixed effects models stratified by presence of iCNS metastases at study entry, prior chemotherapy at Baseline.|Mixed Models Analysis|A mixed effect model is used with an unstructured covariance matrix.||||11.00|0.58|0.0295
70936669|NCT00824850|141373415|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
70936670|NCT00824850|141373415|SUPERIORITY_OR_OTHER||difference in proportions|3.0|||||TWO_SIDED|95.0|-6.8|15.8||||||Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||15.8|-6.8|
70936671|NCT00824850|141373415|SUPERIORITY_OR_OTHER||difference in proportions|-2.6|||||TWO_SIDED|95.0|-13.9|7.6||||||Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||7.6|-13.9|
70936672|NCT00824850|141373416|SUPERIORITY_OR_OTHER||geometric mean fold rise|29.47|||||TWO_SIDED|95.0|17.61|49.33|||||Confidence intervals (CI) for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: Geometric mean fold rises (GMFRs) were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||49.33|17.61|
70936673|NCT00824850|141373416|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.34|||||TWO_SIDED|95.0|8.49|15.13|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||15.13|8.49|
70936674|NCT00824850|141373416|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.58|||||TWO_SIDED|95.0|4.06|7.67|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||7.67|4.06|
71060819|NCT04179838|141628967|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.||||0.58
71060820|NCT02099786|141628983|SUPERIORITY||Odds Ratio (OR)|2.2||||0.27|TWO_SIDED|95.0|0.55|8.8|||Regression, Logistic|||Null hypothesis: There is no difference in the number of participants with ASHA-significant threshold shifts between treatment arms.||8.8|.55|.27
71060821|NCT02099786|141628983|SUPERIORITY||Odds Ratio (OR)|1.4||||0.67|TWO_SIDED|95.0|0.3|5.9|||Regression, Logistic|||Null hypothesis: There is no difference in the number of participants with CTCAE grade 1 or greater hearing loss between treatment arms.||5.9|.3|.67
71060822|NCT02099786|141628984|SUPERIORITY||Odds Ratio (OR)|0.92||||0.88|TWO_SIDED|95.0|0.29|2.9|||Regression, Logistic|||Null hypothesis is no difference in audiology clinic use between treatment arms.||2.9|.29|.88
71060823|NCT02099786|141628985|NON_INFERIORITY|We require a non-inferiority margin of no more than 1.1 mortality odds among COMP-VA patients relative to Usual Care patients. This means that the upper 95% confidence bound for the fitted odds ratio must be less than 1.1 to reject the null hypothesis that COMP-VA induces extra mortality risk.|Odds Ratio (OR)|1.9|||||ONE_SIDED|||||||||||||
71060824|NCT02099786|141628986|SUPERIORITY|||||||0.72||||||The a priori threshold for statistical significance is .05|t-test, 2 sided|||||||.72
71060825|NCT00080912|141628987|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The original sample size was determined based on the non-inferiority. The original sample size is based on assumption of response rate on the multiple fraction arm is 70%, 260 patients were required in each treatment arm to have 80% power to exclude, with a one sided alpha of 0.05, a response rate of 60% or less in the single fraction radiation group (non-inferiority margin =10%). Given an inevaluability rate of 30%, 850 patients (425 for each treatment arm) were randomized to the study.|Risk Difference (RD)|4.0||||0.03|ONE_SIDED|95.0||9.2||p-value is for one-sided non-inferiority test|Cochran-Mantel-Haenszel||The upper limit of one-sided 95% CI for the response rate difference was 9.2%, which was below the pre-specified 10% non-inferiority boundary|||9.2||0.03
71060826|NCT00818766|141628993|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.3||||0.26||95.0|-11.3|2.7|||Fisher Exact|||||2.7|-11.3|.26
71060827|NCT00818766|141628994|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.93||||0.77|TWO_SIDED|95.0|-6.1|4.3|||Fisher Exact|||||4.3|-6.1|0.77
71060828|NCT00818766|141628995|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.4||||0.21|TWO_SIDED|95.0|-8.3|1.6|||Fisher Exact|||||1.6|-8.3|.21
71060829|NCT00818766|141628996|SUPERIORITY_OR_OTHER|||||||0.49|||||||Fisher Exact|||||||.49
71060830|NCT00818766|141628998|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Fisher Exact|||||||.25
71060831|NCT00818766|141628999|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Fisher Exact|||||||.25
71060832|NCT01996241|141629004|OTHER|Odds ratio (95% CI), p-value for all the outcomes.|Odds Ratio (OR)|1.01||||0.98|TWO_SIDED|95.0|0.7|1.38||Adjusted models controlled for cluster, village strata, village type, caste, household literacy status, stratum (individual-level data endline) and poor learning environment at school, school dropout, and marriage (cluster-level summaries baseline)|Regression, Logistic|Mixed-effects||||1.38|0.7|0.98
71060833|NCT01996241|141629005|OTHER||Odds Ratio (OR)|1.0||||0.98|TWO_SIDED|95.0|0.7|1.4||Adjusted models controlled for cluster, village strata, village type, caste, household literacy status, stratum (individual-level data endline) and poor learning environment at school, school dropout, and marriage (cluster-level summaries baseline)|Regression, Logistic|Mixed-effects||||1.4|0.7|0.98
71060834|NCT01996241|141629006|OTHER||Odds Ratio (OR)|1.32||||0.331|TWO_SIDED|95.0|0.2|2.31||Adjusted for village strata and cluster, village type, caste, household literacy status, stratum using individual-level data and poor learning environment at school, school dropout, and marriage (in the form of cluster-level summaries).|Regression, Logistic|Mixed-effects||||2.31|0.2|0.331
71060835|NCT01996241|141629007|OTHER||Odds Ratio (OR)|0.83||||0.26|TWO_SIDED|95.0|0.6|1.15||Adjusted models controlled for cluster, village strata, village type, caste, household literacy status, stratum (individual-level data endline) and poor learning environment at school, school dropout, and marriage (cluster-level summaries baseline)|Regression, Logistic|Mixed-effects||||1.15|0.6|0.26
71060836|NCT01996241|141629008|OTHER||Odds Ratio (OR)|1.05||||0.79|TWO_SIDED|95.0|0.7|1.55||Adjusted models controlled for cluster, village strata, village type, caste, household literacy status, stratum (individual-level data endline) and poor learning environment at school, school dropout, and marriage (cluster-level summaries baseline)|Regression, Logistic|Mixed-effects||||1.55|0.7|0.79
71060837|NCT01996241|141629009|OTHER||Odds Ratio (OR)|0.83||||0.45|TWO_SIDED|95.0|0.5|1.34||Adjusted models controlled for cluster, village strata, village type, caste, household literacy status, stratum (individual-level data endline) and poor learning environment at school, school dropout, and marriage (cluster-level summaries baseline)|Regression, Logistic|Mixed-effects||||1.34|0.5|0.45
71060838|NCT01111318|141629034|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio|123.15|STANDARD_DEVIATION|29.0|||TWO_SIDED|90.0|98.89|153.36|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).|Standard deviation is actually the geometric coefficient of variation|Ratio calculated as mild divided by healthy||153.36|98.89|
71060839|NCT01111318|141629034|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio|146.97|STANDARD_DEVIATION|29.0|||TWO_SIDED|90.0|118.02|183.02|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).|Standard deviation is actually the geometric coefficient of variation|Ratio calculated as moderate divided by healthy||183.02|118.02|
71060840|NCT01111318|141629034|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio|174.7|STANDARD_DEVIATION|29.0|||TWO_SIDED|90.0|140.29|217.55|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).|Standard deviation is actually the geometric coefficient of variation|Ratio calculated as severe divided by healthy||217.55|140.29|
71060841|NCT01111318|141629035|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio|103.81|STANDARD_DEVIATION|30.7|||TWO_SIDED|90.0|82.29|130.95|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).|Standard deviation is actually the geometric coefficient of variation|Ratio calculated as mild divided by healthy||130.95|82.29|
71060842|NCT01111318|141629035|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio|123.31|STANDARD_DEVIATION|30.7|||TWO_SIDED|90.0|97.74|155.55|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).|Standard deviation is actually the geometric coefficient of variation|Ratio calculated as moderate divided by healthy||155.55|97.74|
71109998|NCT00405288|141725330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.0|STANDARD_DEVIATION|450.0||0.17|TWO_SIDED|95.0|0.0|200.0|||t-test, 2 sided|||"Null hypothesis: Birth weight in pregnancies exposed to Proctofoam-HC will be the same as control pregnancies.~To detect a clinically significant decrease of 200 g in birth weight at a power of 80% and alpha of 5%, 200 women per group were required. Post hoc power analysis of our cohort revealed that, in fact, we had a 91.5% power to detect a 200 g difference in birth weight between the two groups."||200|0|0.17
71109999|NCT00405288|141725331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|3.0||0.16|TWO_SIDED|95.0|0.0|3.0|||Wilcoxon (Mann-Whitney)|||||3|0|0.16
71060843|NCT01111318|141629035|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio|148.41|STANDARD_DEVIATION|30.7|||TWO_SIDED|90.0|117.65|187.23|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).|Standard deviation is actually the geometric coefficient of variation|Ratio calculated as severe divided by healthy||187.23|117.65|
71060844|NCT02091856|141629048|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance was set at .05|ANOVA|Changes in primary outcome measures were evaluated using repeated measures ANOVA for three groups: C-CBT, R-CBT, WLCG and two time points: pre \& post||It was hypothesized that regardless of the CBT version received (conventional or religious), those in the active treatments would achieve a greater reduction in depressive and associated symptoms than participants in the wait-list condition.||||<0.001
71060845|NCT02091856|141629049|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||The a priori threshold for statistical significance was set at .05|ANOVA|Changes in secondary outcome measures were evaluated using repeated measures ANOVA (C-CBT, R-CBT, WLCG at pre- and post-intervention).||||||>0.05
71110000|NCT00405288|141725332|SUPERIORITY_OR_OTHER||chi square|30.0||||0.003||95.0|||||McNemar|||The null hypothesis is that the proportion of vaginal deliveries in the Proctofoam and Control groups will be the same (ie. there will not be a greater proportion of complicated deliveries in either group).||||0.003
71060846|NCT02091856|141629050|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||The a priori threshold for statistical significance was set at .05|ANOVA|||||||<0.01
71060847|NCT02091856|141629051|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The a priori threshold for statistical significance was set at .05|ANOVA|||||||<0.001
71060848|NCT02091856|141629052|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||The a priori threshold for statistical significance was set at .05|t-test, 1 sided|||||||<0.01
71060849|NCT03207776|141629096|SUPERIORITY||Odds Ratio (OR)|0.8||||0.041|TWO_SIDED|95.0|0.64|0.99|||Mixed Models Analysis|||||0.99|0.64|0.041
71060850|NCT03207776|141629097|SUPERIORITY||Odds Ratio (OR)|0.99||||0.952|TWO_SIDED|95.0|0.69|1.42|||Mixed Models Analysis|||||1.42|0.69|0.952
71060851|NCT03207776|141629098|SUPERIORITY||Odds Ratio (OR)|0.91||||0.472|TWO_SIDED|95.0|0.71|1.17|||Mixed Models Analysis|||||1.17|0.71|0.472
71110001|NCT00405288|141725333|SUPERIORITY_OR_OTHER||chi square|5.0||||0.55||95.0|||||McNemar|||The null hypothesis is that the proportion of pre-term births in the Proctofoam and Control groups will be the same.||||0.55
71110002|NCT00405288|141725334|SUPERIORITY_OR_OTHER||chi square|10.0||||0.97||95.0|||||McNemar|||Fetal Distress The null hypothesis is that the proportion of fetal distress in the Proctofoam and Control groups will be the same.||||0.97
71110003|NCT00405288|141725335|SUPERIORITY_OR_OTHER||binary|3.0||||0.31||95.0|||||McNemar|||Low birth weight \<2,500g; The null hypothesis is that the proportion of low birth weight babies in the Proctofoam and Control groups will be the same.||||0.31
71110004|NCT00405288|141725336|SUPERIORITY_OR_OTHER||chi square|10.0||||0.87||95.0|||||McNemar|||The null hypothesis is that the proportion of healthy babies (not requiring NICU (neonatal intensive care unit) or additional medical monitoring) will be the same between the Proctofoam and Control groups.||||0.87
71110005|NCT00405288|141725337|SUPERIORITY_OR_OTHER||proportion|4.0||||0.99||95.0|||||Fisher Exact|||||||0.99
71110006|NCT00405288|141725338|SUPERIORITY_OR_OTHER||proportion|3.0||||0.99||95.0|||||Fisher Exact|||||||0.99
70936675|NCT00824850|141373416|SUPERIORITY_OR_OTHER||geometric mean fold rise|71.09|||||TWO_SIDED|95.0|40.74|124.08|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||124.08|40.74|
70936676|NCT00824850|141373416|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.91|||||TWO_SIDED|95.0|4.92|12.73|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||12.73|4.92|
71060852|NCT03207776|141629099|SUPERIORITY||Odds Ratio (OR)|1.14||||0.544|TWO_SIDED|95.0|0.74|1.77|||Mixed Models Analysis|||||1.77|0.74|0.544
71060853|NCT00780338|141629103|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||We first conducted an intent-to-treat analysis by fitting a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.||||.58
71060854|NCT00780338|141629105|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||We first conducted an intent-to-treat analysis by fitting a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.||||.61
71060855|NCT00780338|141629106|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||Mirroring the intent-to-treat analysis (but comparing AGTO users to AGTO non users instead), we fitted a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time.||||.09
71060856|NCT00780338|141629107|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||Mirroring the intent-to-treat analysis (but comparing AGTO users to AGTO non users instead), we fitted a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time.||||.01
71060857|NCT00780338|141629108|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||Mirroring the intent-to-treat analysis (but comparing AGTO users to AGTO non users instead), we fitted a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time.||||.00
71060858|NCT00780338|141629109|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||We first conducted an intent-to-treat analysis by fitting a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.||||.45
70936677|NCT00824850|141373416|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.56|||||TWO_SIDED|95.0|2.87|7.26|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||7.26|2.87|
71060859|NCT00780338|141629110|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||We first conducted an intent-to-treat analysis by fitting a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.||||.65
70852345|NCT00966875|141193428|SUPERIORITY_OR_OTHER|||||||0.388|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.388
70852346|NCT00966875|141193428|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.033
71060860|NCT00780338|141629111|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||Mirroring the intent-to-treat analysis (but comparing AGTO users to AGTO non users instead), we fitted a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time.||||.00
71110007|NCT00405288|141725339|SUPERIORITY_OR_OTHER||proportion|2.0||||0.99||95.0|||||Fisher Exact|||||||0.99
71110008|NCT00405288|141725340|SUPERIORITY_OR_OTHER||proportions|2.0||||0.35||95.0|||||Fisher Exact|||||||0.35
71060861|NCT00780338|141629112|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||We first conducted an intent-to-treat analysis by fitting a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.||||.61
71060862|NCT00780338|141629113|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||Mirroring the intent-to-treat analysis (but comparing AGTO users to AGTO non users instead), we fitted a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time.||||.02
71060863|NCT02002221|141629115|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.91|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-1.08|-0.73|||ANCOVA|||H0: δ vildagliptin 50 mg bid = δ placebo versus H1: δ Vildagliptin 50 mg bid \< δ placebo,||-0.73|-1.08|< 0.001
71060864|NCT01518322|141629130|SUPERIORITY_OR_OTHER||Kappa Statistics|0.049|||||TWO_SIDED|95.0|-0.0895|0.1875||||||Kappa statistics were used to determine the level of agreement between FeNO measurements and asthma diagnosis using the a dichotomous schemes a measurement greater than 35 ppb for children under the age of 12 years or greater than 50 ppb for subjects at least 12 years of age was considered high.||0.1875|-0.0895|
71060865|NCT03535740|141629181|OTHER|||||||0.0763||||||P-value was based on the comparison of the confirm ORR among the 90/180mg group against a fixed response rate of 20%.|Exact Binomial Test|The calculation was based on an exact binomial test with a total 1-sided alpha level of 0.025 at primary analysis.||||||0.0763
71060866|NCT05807828|141629199|SUPERIORITY||Median Difference (Final Values)|7.5|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The median difference between the cup angle of the Control Group for Cup Training and the cup angle of VR Group for Cup Training.||||<0.05
71060867|NCT05807828|141629199|SUPERIORITY||Median Difference (Final Values)|291.5|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The median difference between the stem angle of the Control Group for Stem Training and the stem angle of VR Group for Stem Training.||||<0.05
71110009|NCT04067492|141725342|OTHER|"The study was planned to randomize 85 patients: 15 patients in the RPH-104 4 mg group, and 14 patients in the RPH-104 20 mg, 40 mg, 80 mg and 160 mg groups each, a total of 14 patients in the Voltaren® (diclofenac) group.~The sample size was calculated assuming a standard deviation of 26 mm for change in pain intensity at 72 hours."|Mean Difference (Final Values)|28.63||||0.1331|TWO_SIDED|95.0|4.21|53.05||p-value, group|ANCOVA||Adjusted mean difference. Comparison with the control group \[RPH-104 - Diclofenac\].|It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.||53.05|4.21|0.1331
71060868|NCT05807828|141629200|SUPERIORITY||Mean Difference (Final Values)|54.5|STANDARD_DEVIATION|106.6|<|0.05|TWO_SIDED||||||paired t-test|||Each medical student carried out an implantation following VR training and without VR training. Therefore, there was a deviation (mean difference) between the predefined target and the implanted inclination for the cup or the stem version for the same medical student with VR training.||||<0.05
71060869|NCT05807828|141629200|SUPERIORITY||Mean Difference (Final Values)|89.8|STANDARD_DEVIATION|133.9|<|0.05|TWO_SIDED||||||paired t-test|||Each medical student carried out an implantation following VR training and without VR training. Therefore, there was a deviation (mean difference) between the predefined target and the implanted inclination for the cup or the stem version for the same medical student without VR training (control).||||<0.05
71060870|NCT05807828|141629201|SUPERIORITY||Median Difference (Final Values)|14.0|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Median difference between the time needed for cup implantation for Control cup group and the time needed for cup implantation for VR cup group||||<0.05
71060871|NCT05807828|141629201|SUPERIORITY||Median Difference (Final Values)|2.0|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Median difference between the time needed for stem implantation for Control stem group and the time needed for stem implantation for VR stem group||||<0.05
71060872|NCT02756611|141629217|SUPERIORITY||||||<|0.001|||||||Binomial test|||The null hypothesis stated that the CR rate for BCRi-naïve participants would be ≤ 6%, based on the CR rate reported for current therapies at the time the study was designed, with an alternative hypothesis that the CR rate would be \> 6%. If the p-value for this test was \< 0.025, the null hypothesis would be rejected.||||<0.001
71060873|NCT02756611|141629228|SUPERIORITY||||||<|0.001|||||||Binomial test|||The null hypothesis stated that the CR rate for BCRi-naïve participants would be ≤ 6%, based on the CR rate reported for current therapies at the time the study was designed, with an alternative hypothesis that the CR rate would be \> 6%. If the p-value for this test was \< 0.025, the null hypothesis would be rejected.||||<0.001
71060874|NCT03135015|141629245|OTHER||Percentage Change from Control|-14.09||||0.1146|TWO_SIDED||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||0.1146
71060875|NCT03135015|141629245|OTHER||Percentage Change from Control|-17.42||||0.0519|TWO_SIDED||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||0.0519
71060876|NCT03135015|141629245|OTHER||Percentage Change from Control|-8.95|||||TWO_SIDED|||||||||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||
71060877|NCT03135015|141629246|OTHER|||||||0.1146|||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons||||0.1146
71060878|NCT03135015|141629246|OTHER|||||||0.0519|||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons||||0.0519
71060879|NCT03135015|141629247|OTHER|||||||0.5827|||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||0.5827
71060880|NCT03135015|141629247|OTHER|||||||0.5485|||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||0.5485
71060881|NCT03135015|141629248|OTHER||Percentage Change from Control|-8.53||||0.5827|TWO_SIDED||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||0.5827
71060882|NCT03135015|141629248|OTHER||Percentage Change from Control|9.32||||0.5485|TWO_SIDED||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||0.5485
71060883|NCT03135015|141629249|OTHER|||||||0.1234|||||||t-test, 2 sided|||||||0.1234
71060884|NCT03135015|141629249|OTHER|||||||0.0331|||||||t-test, 2 sided|||||||0.0331
71060885|NCT03135015|141629250|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.0500
71060886|NCT03135015|141629250|OTHER|||||||0.0568|||||||t-test, 2 sided|||||||0.0568
71060887|NCT03135015|141629251|OTHER|||||||0.0509|||||||t-test, 2 sided|||||||0.0509
71060888|NCT03135015|141629251|OTHER|||||||0.5016|||||||t-test, 2 sided|||||||0.5016
71060889|NCT03135015|141629252|OTHER|||||||0.8444|||||||t-test, 2 sided|||||||0.8444
70852347|NCT00966875|141193428|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.039
71060890|NCT03135015|141629252|OTHER|||||||0.9681|||||||t-test, 2 sided|||||||0.9681
71060891|NCT03135015|141629252|OTHER|||||||0.1022|||||||t-test, 2 sided|||||||.1022
71060892|NCT03135015|141629252|OTHER|||||||0.3738|||||||t-test, 2 sided|||||||.3738
71060893|NCT03135015|141629252|OTHER||Mean Difference (Net)|-13.123|STANDARD_ERROR_OF_MEAN|8.55|||TWO_SIDED||||||||Percentage Change from Control|||||
71060894|NCT03135015|141629252|OTHER||Mean Difference (Net)|-10.362|STANDARD_ERROR_OF_MEAN|10.387|||TWO_SIDED||||||||Percentage Change from Control|||||
70852348|NCT00966875|141193428|SUPERIORITY_OR_OTHER|||||||0.199|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.199
70852349|NCT00966875|141193428|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.039
70852350|NCT00966875|141193428|SUPERIORITY_OR_OTHER|||||||0.696|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.696
70852351|NCT00966875|141193428|SUPERIORITY_OR_OTHER|||||||0.112|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.112
70852352|NCT00966875|141193430|SUPERIORITY_OR_OTHER|||||||0.017||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.017
70852353|NCT00966875|141193430|SUPERIORITY_OR_OTHER|||||||0.042||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.042
70852354|NCT00966875|141193430|SUPERIORITY_OR_OTHER|||||||0.004||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.004
70852355|NCT00966875|141193430|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
70852356|NCT00966875|141193430|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
70852357|NCT00966875|141193430|SUPERIORITY_OR_OTHER|||||||0.008||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.008
70852358|NCT00966875|141193430|SUPERIORITY_OR_OTHER|||||||0.007||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.007
70852359|NCT00966875|141193432|SUPERIORITY_OR_OTHER|||||||0.093||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.093
71060895|NCT03135015|141629252|OTHER||Mean Difference (Net)|-13.738|STANDARD_ERROR_OF_MEAN|13.463|||TWO_SIDED||||||||Percentage Change from Control|||||
71060896|NCT03135015|141629252|OTHER||Mean Difference (Net)|-12.929|STANDARD_ERROR_OF_MEAN|14.282|||TWO_SIDED||||||||Percentage Change from Control|||||
71060897|NCT03135015|141629253|OTHER|||||||0.0111|||||||t-test, 2 sided|||||||0.0111
70852360|NCT00966875|141193432|SUPERIORITY_OR_OTHER|||||||0.023||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.023
70852361|NCT00966875|141193432|SUPERIORITY_OR_OTHER|||||||0.006||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.006
70852362|NCT00966875|141193432|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.001
70852363|NCT00966875|141193432|SUPERIORITY_OR_OTHER|||||||0.028||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.028
70852364|NCT00966875|141193432|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
70852365|NCT00966875|141193432|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
70852366|NCT00966875|141193434|SUPERIORITY_OR_OTHER|||||||0.247||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.247
70852367|NCT00966875|141193434|SUPERIORITY_OR_OTHER|||||||0.315||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.315
70852368|NCT00966875|141193434|SUPERIORITY_OR_OTHER|||||||0.006||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.006
70852369|NCT00966875|141193434|SUPERIORITY_OR_OTHER|||||||0.042||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.042
70852370|NCT00966875|141193434|SUPERIORITY_OR_OTHER|||||||0.055||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.055
70852371|NCT00966875|141193434|SUPERIORITY_OR_OTHER|||||||0.365||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.365
70852372|NCT00966875|141193434|SUPERIORITY_OR_OTHER|||||||0.005||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.005
70852373|NCT00966875|141193436|SUPERIORITY_OR_OTHER|||||||0.778||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.778
70852374|NCT00966875|141193436|SUPERIORITY_OR_OTHER|||||||0.865||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.865
70852375|NCT00966875|141193436|SUPERIORITY_OR_OTHER|||||||0.03||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.030
70852376|NCT00966875|141193436|SUPERIORITY_OR_OTHER|||||||0.331||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.331
70852377|NCT00966875|141193436|SUPERIORITY_OR_OTHER|||||||0.039||||||P-value is for Week 12..|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.039
70852378|NCT00966875|141193436|SUPERIORITY_OR_OTHER|||||||0.292||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.292
70852379|NCT00966875|141193436|SUPERIORITY_OR_OTHER|||||||0.003||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.003
70852380|NCT00966875|141193438|SUPERIORITY_OR_OTHER|||||||0.09||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.090
71060898|NCT03135015|141629253|OTHER|||||||0.1684|||||||t-test, 2 sided|||||||0.1684
71060899|NCT03135015|141629253|OTHER||Mean Difference (Net)|-11.604|STANDARD_ERROR_OF_MEAN|6.722|||TWO_SIDED||||||||Percentage Change from Control|||||
71060900|NCT03135015|141629253|OTHER||Mean Difference (Net)|12.755|STANDARD_ERROR_OF_MEAN|8.489|||TWO_SIDED||||||||Percentage Change from Control|||||
71060901|NCT03135015|141629253|OTHER||Mean Difference (Net)|-13.293|STANDARD_ERROR_OF_MEAN|9.664|||TWO_SIDED||||||||Percentage Change from Control|||||
71060902|NCT03135015|141629253|OTHER||Mean Difference (Net)|2.526|STANDARD_ERROR_OF_MEAN|5.813|||TWO_SIDED||||||||Percentage Change from Control|||||
71060903|NCT03135015|141629254|OTHER||Percentage Change from Control|-21.09||||0.0374|TWO_SIDED||||||t-test, 2 sided|||||||0.0374
71060904|NCT03135015|141629255|OTHER||Percentage Change from Control|-24.22||||0.0098|TWO_SIDED||||||t-test, 2 sided|||||||0.0098
70936678|NCT00824850|141373416|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.85|||||TWO_SIDED|95.0|4.51|10.42|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||10.42|4.51|
70936679|NCT00824850|141373416|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.1|||||TWO_SIDED|95.0|6.98|17.64|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||17.64|6.98|
70936680|NCT00824850|141373416|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.68|||||TWO_SIDED|95.0|1.37|2.07|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.07|1.37|
70936681|NCT00824850|141373416|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.52|2.9|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.90|1.52|
70936682|NCT00824850|141373416|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.7|||||TWO_SIDED|95.0|4.77|12.42|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||12.42|4.77|
70936683|NCT00824850|141373416|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.2|||||TWO_SIDED|95.0|4.95|10.48|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||10.48|4.95|
70936684|NCT00824850|141373416|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.02|||||TWO_SIDED|95.0|2.23|4.1|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||4.10|2.23|
70936685|NCT00824850|141373417|SUPERIORITY_OR_OTHER||geometric mean fold rise|19.68|||||TWO_SIDED|95.0|9.99|38.77|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||38.77|9.99|
70936686|NCT00824850|141373417|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.7|||||TWO_SIDED|95.0|3.9|8.33|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||8.33|3.90|
71060905|NCT03135015|141629255|OTHER||Percentage Change from Control|-25.02||||0.0391|TWO_SIDED||||||t-test, 2 sided|||||||0.0391
70936687|NCT00824850|141373417|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.78|||||TWO_SIDED|95.0|2.16|3.57|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||3.57|2.16|
71060906|NCT03135015|141629256|OTHER||Percentage Change from Control|-36.28||||0.0034|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0034
71060907|NCT03135015|141629256|OTHER||Percentage Change from Control|-33.21||||0.0058|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0058
70936688|NCT00824850|141373417|SUPERIORITY_OR_OTHER||geometric mean fold rise|23.46|||||TWO_SIDED|95.0|13.17|41.79|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||41.79|13.17|
71060908|NCT03135015|141629256|OTHER||Percentage Change from Control|-53.27||||0.0016|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0016
70936689|NCT00824850|141373417|SUPERIORITY_OR_OTHER||geometric mean fold rise|13.68|||||TWO_SIDED|95.0|8.94|20.92|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||20.92|8.94|
70936690|NCT00824850|141373417|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.98|||||TWO_SIDED|95.0|6.21|12.97|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||12.97|6.21|
71060909|NCT03135015|141629256|OTHER||Percentage Change from Control|-46.19||||0.0125|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0125
71060910|NCT03135015|141629257|OTHER||Percentage Change from Control|-31.36||||0.0788|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0788
71060911|NCT03135015|141629257|OTHER||Percentage Change from Control|-30.32||||0.0887|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0887
71060912|NCT03135015|141629257|OTHER||Percentage Change from Control|-39.96||||0.0266|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0266
71060913|NCT03135015|141629257|OTHER||Percentage Change from Control|-41.8||||0.0455|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0455
71060914|NCT03135015|141629258|OTHER||Percentage Change from Control|-41.82||||0.0261|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0261
71060915|NCT03135015|141629258|OTHER||Percentage Change from Control|-36.45||||0.0391|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0391
71060916|NCT03135015|141629258|OTHER||Percentage Change from Control|-82.11||||0.0372|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0372
71060917|NCT03135015|141629258|OTHER||Percentage Change from Control|-55.81||||0.1631|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.1631
71060918|NCT03135015|141629259|OTHER||Percentage Change from Control|-46.43||||0.0303|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in insulin will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0303
71060919|NCT03135015|141629259|OTHER||Percentage Change from Control|-19.64||||0.4283|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in insulin will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.4283
71060920|NCT04583735|141629272|SUPERIORITY||LSMean difference|-1.48|STANDARD_ERROR_OF_MEAN|0.396||0.0004|TWO_SIDED|95.0|-2.28|-0.69||MMRM analysis with an unstructured variance-covariance matrix including change from Baseline value as dependent variable \& covariates: Baseline value, treatment group, visit, visit-by-treatment \& visit-by-Baseline value interactions.|MMRM|||||-0.69|-2.28|0.0004
71060921|NCT00683657|141629365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|STANDARD_ERROR_OF_MEAN|4.16||0.0001|TWO_SIDED|95.0|-25.1|-8.5||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|ANCOVA Model: post - pre = pre treatment|Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin.|With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.||-8.5|-25.1|0.0001
71060922|NCT00683657|141629366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.2|STANDARD_ERROR_OF_MEAN|7.1|<|0.0001|TWO_SIDED|95.0|-44.4|-16.1||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|ANCOVA model: post - pre = pretreatment|Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin|With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.||-16.1|-44.4|<0.0001
71060923|NCT00683657|141629367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.4|STANDARD_ERROR_OF_MEAN|10.41||0.001|TWO_SIDED|95.0|-56.2|-14.7||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|ANCOVA model: post - pre = pretreatment|Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin|With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.||-14.7|-56.2|0.0010
70852381|NCT00966875|141193438|SUPERIORITY_OR_OTHER|||||||0.131||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.131
70852382|NCT00966875|141193438|SUPERIORITY_OR_OTHER|||||||0.008||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.008
70852383|NCT00966875|141193438|SUPERIORITY_OR_OTHER|||||||0.013||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.013
71060924|NCT00683657|141629368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.7|STANDARD_ERROR_OF_MEAN|4.22|<|0.0001|TWO_SIDED|95.0|-27.1|-10.3||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|ANCOVA Model: post - pre = pretreatment|Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin|With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.||-10.3|-27.1|<0.0001
71060925|NCT00683657|141629369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3|STANDARD_ERROR_OF_MEAN|4.0||0.0002|TWO_SIDED|95.0|-23.3|-7.4||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|ANCOVA Model: post - pre = pretreatment|Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin|With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.||-7.4|-23.3|0.0002
71060926|NCT00931528|141629395|SUPERIORITY_OR_OTHER||Difference in percentages|5.0||||0.49|TWO_SIDED|95.0|1.0|9.0|||Chi-squared|||Sample size calculations were based on the hypothesis that the use of tadalafil would statistically significant increase the proportion of patients maintaining spontaneous erectile function compared to the use of placebo. Based on a 2-sided Fisher exact test with alpha=0.05, 91 patients/arm would provide 80% statistical power to detect an increase from 20% to 40% in spontaneous erectile response at weeks 28-30. Although designed for the Fisher exact test, Chi-square was used and reported.||9|1|0.49
71060927|NCT00931528|141629395|SUPERIORITY|||||||0.2386|||||||Regression, Logistic|||Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX vs. N0)\] were retained in the model. (Dropped: ethnicity, Zubrod, T stage, prostate-specific antigen (PSA).) The results for each explanatory variable are reported separately. Treatment arm is reported here.||||0.2386
71060928|NCT00931528|141629395|SUPERIORITY|||||||0.7908|||||||Regression, Linear|||Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX vs. N0)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.)The results for each explanatory variable are reported separately. RT method is reported here.||||0.7908
71060929|NCT00931528|141629395|SUPERIORITY|||||||0.0467|||||||Regression, Logistic|||Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX vs. N0)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. Age is reported here.||||0.0467
71060930|NCT00931528|141629395|SUPERIORITY|||||||0.0068|||||||Regression, Logistic|||Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX vs. N0)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. N Stage is reported here.||||0.0068
71060931|NCT00931528|141629396|SUPERIORITY|||||||0.93|||||||Chi-squared|2-sided significance level = 0.05||Year 1||||0.93
71060932|NCT00931528|141629396|SUPERIORITY|||||||0.58|||||||Chi-squared|2-sided significance level = 0.05||Year 2||||0.58
71060933|NCT00931528|141629396|SUPERIORITY|||||||0.9501|||||||Regression, Logistic|||Year 1: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[none\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, N stage, T stage, PSA.) The results for each explanatory variable are reported separately. Treatment arm is reported here.||||0.9501
71060934|NCT00931528|141629396|SUPERIORITY|||||||0.102|||||||Regression, Logistic|||Year 1: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[none\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, N stage, T stage, PSA.) The results for each explanatory variable are reported separately. RT method is reported here.||||0.1020
70852384|NCT00966875|141193438|SUPERIORITY_OR_OTHER|||||||0.01||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.010
70852385|NCT00966875|141193438|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
70852386|NCT00966875|141193438|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
70852387|NCT00966875|141193440|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
70852388|NCT00966875|141193440|SUPERIORITY_OR_OTHER|||||||0.012||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.012
70936691|NCT00824850|141373417|SUPERIORITY_OR_OTHER||geometric mean fold rise|9.0|||||TWO_SIDED|95.0|5.91|13.72|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||13.72|5.91|
71060935|NCT00931528|141629396|SUPERIORITY|||||||0.1855|||||||Regression, Logistic|||Year 1: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[none\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, N stage, T stage, PSA.) The results for each explanatory variable are reported separately. Age is reported here.||||0.1855
71060936|NCT00931528|141629396|SUPERIORITY|||||||0.5739|||||||Regression, Logistic|||Year 2: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. Treatment arm is reported here.||||0.5739
71060937|NCT00931528|141629396|SUPERIORITY|||||||0.0422|||||||Regression, Logistic|||Year 2: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. RT method is reported here.||||0.0422
71060938|NCT00931528|141629396|SUPERIORITY|||||||0.5237|||||||Regression, Logistic|||Year 2: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. Age is reported here.||||0.5237
71060939|NCT00931528|141629396|SUPERIORITY|||||||0.477|||||||Regression, Logistic|||Year 2: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. N Stage is reported here.||||0.4770
71060940|NCT00931528|141629397|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|Significance level = 0.05||Week 30||||0.97
71060941|NCT00931528|141629397|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|Significance level = 0.05||Year 1||||0.99
71060942|NCT00931528|141629397|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|Significance level = 0.05||Year 2||||0.24
71060943|NCT00931528|141629398|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|Significance level = 0.05||Week 30||||0.70
71060944|NCT00931528|141629398|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|Significance level = 0.05||Year 1||||0.65
71060945|NCT00931528|141629398|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|Significance level = 0.05||||||0.72
71060946|NCT00931528|141629399|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|Significance level = 0.05||Week 30||||0.14
71060947|NCT00931528|141629399|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|Significance level = 0.05||Year 1||||0.64
71060948|NCT00931528|141629399|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|Significance level = 0.05||Year 2||||0.18
71060949|NCT00931528|141629400|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|Significance level = 0.05||Week 30||||0.67
71060950|NCT00931528|141629400|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|Significance level = 0.05||Year 1||||0.98
71060951|NCT00931528|141629400|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|Significance level = 0.05||Year 2||||0.96
71060952|NCT00931528|141629401|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|Significance level = 0.05||Week 30||||0.86
71060953|NCT00931528|141629401|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|Significance level = 0.05||Year 1||||0.93
71060954|NCT00931528|141629401|SUPERIORITY|||||||0.52|||||||t-test, 2 sided|Significance level = 0.05||Year 2||||0.52
71060955|NCT01321749|141629458|SUPERIORITY_OR_OTHER||||||<|0.05||5.0|||||Log Rank|||||||<0.05
71060956|NCT02750618|141629461|SUPERIORITY||Least Squares Mean Difference|0.96|||<|0.0001|TWO_SIDED|95.0|0.73|1.19|||GEE model|||||1.19|0.73|< 0.0001
71060957|NCT02750618|141629463|SUPERIORITY||Difference in LS Means|2.21|||<|0.0001|TWO_SIDED|95.0|2.07|2.35|||GEE model|||||2.35|2.07|< 0.0001
71060958|NCT02750618|141629464|SUPERIORITY||Difference in LS Means|2.23|||<|0.0001|TWO_SIDED|95.0|2.01|2.45|||GEE model|||The GEE model includes the RGI-C score as the dependent variable, visit as a factor, age and RSS at baseline as covariates, with exchangeable covariance structure. The least squares (LS) mean, standard error (SE), 95% confidence interval (CI) and 2-sided p-value are from the GEE model.||2.45|2.01|< 0.0001
71060959|NCT02750618|141629465|SUPERIORITY||Difference in LS Means|-1.75|||<|0.0001|TWO_SIDED|95.0|-1.98|-1.53|||GEE model|||||-1.53|-1.98|< 0.0001
71060960|NCT02750618|141629466|SUPERIORITY||Difference in LS Means|-2.02|||<|0.0001|TWO_SIDED|95.0|-2.25|-1.8||The GEE model includes the change from baseline in RSS as the dependent variable, visit as a factor, age and RSS at baseline as covariates, with exchangeable covariance structure.|GEE model|||||-1.80|-2.25|< 0.0001
71060961|NCT02750618|141629467|SUPERIORITY||Difference in LS Means|1.21|||<|0.0001|TWO_SIDED|95.0|0.9|1.51|||GEE model|||||1.51|0.90|< 0.0001
71060962|NCT02750618|141629468|SUPERIORITY||Difference in LS Means|1.51|||<|0.0001|TWO_SIDED|95.0|1.27|1.76||The GEE model includes the RGI-C score as the dependent variable, visit as a factor, age and RSS at baseline as covariates, with exchangeable covariance structure. The LS Mean, SE, 95% CI and 2-sided p-value are from the GEE model.|GEE|||||1.76|1.27|< 0.0001
71060963|NCT02750618|141629472|SUPERIORITY||Difference in LS Means|-82.91||||0.0004|TWO_SIDED|95.0|-128.68|-37.15|||GEE model|||Week 4||-37.15|-128.68|0.0004
71060964|NCT02750618|141629472|SUPERIORITY||Difference in LS Means|-83.84||||0.064|TWO_SIDED|95.0|-172.55|4.88|||GEE model|||Week 12||4.88|-172.55|0.0640
71060965|NCT02750618|141629472|SUPERIORITY||Difference in LS Means|-161.38|||<|0.0001|TWO_SIDED|95.0|-186.7|-136.05|||GEE model|||Week 20||-136.05|-186.70|< 0.0001
71060966|NCT02750618|141629472|SUPERIORITY||Difference in LS Means|-214.99|||<|0.0001|TWO_SIDED|95.0|-241.7|-188.28|||GEE model|||Week 40||-188.28|-241.70|< 0.0001
71060967|NCT02750618|141629472|SUPERIORITY||Difference in LS Means|-226.58|||<|0.0001|TWO_SIDED|95.0|-249.11|-204.06|||GEE model|||Week 48||-204.06|-249.11|< 0.0001
71060968|NCT02750618|141629472|SUPERIORITY||Difference in LS Means|-216.45|||<|0.0001|TWO_SIDED|95.0|-248.13|-184.77|||GEE model|||Week 56||-184.77|-248.13|< 0.0001
71060969|NCT02750618|141629472|SUPERIORITY||Difference in LS Means|-216.76|||<|0.0001|TWO_SIDED|95.0|-241.66|-191.86|||GEE model|||Week 64||-191.86|-241.66|< 0.0001
71060970|NCT02750618|141629472|SUPERIORITY||LS Mean|-231.22|||<|0.0001|TWO_SIDED|95.0|-262.51|-199.93|||GEE|||Week 76||-199.93|-262.51|< 0.0001
71060971|NCT02750618|141629472|SUPERIORITY||LS Mean|-237.78|||<|0.0001|TWO_SIDED|95.0|-262.94|-212.62|||GEE|||Week 88||-212.62|-262.94|< 0.0001
71060972|NCT02750618|141629472|SUPERIORITY||LS Mean|-218.14|||<|0.0001|TWO_SIDED|95.0|-248.21|-188.08|||GEE|||Week 100||-188.08|-248.21|< 0.0001
71060973|NCT02750618|141629472|SUPERIORITY||LS Mean|-233.91|||<|0.0001|TWO_SIDED|95.0|-255.66|-212.16|||GEE|||Week 112||-212.16|-255.66|< 0.0001
71060974|NCT02750618|141629472|SUPERIORITY||LS Mean|-252.22|||<|0.0001|TWO_SIDED|95.0|-268.51|-235.93|||GEE|||Week 124||-235.93|-268.51|< 0.0001
71060975|NCT02750618|141629472|SUPERIORITY||LS Mean|-267.89|||<|0.0001|TWO_SIDED|95.0|-293.61|-242.16|||GEE|||Week 136||-242.16|-293.61|< 0.0001
71060976|NCT02750618|141629472|SUPERIORITY||LS Mean|-248.05|||<|0.0001|TWO_SIDED|95.0|-272.85|-223.25|||GEE|||Week 148||-223.25|-272.85|< 0.0001
70936692|NCT00824850|141373417|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.58|||||TWO_SIDED|95.0|5.36|10.72|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||10.72|5.36|
71060977|NCT02750618|141629472|SUPERIORITY||LS Mean|-248.47|||<|0.0001|TWO_SIDED|95.0|-270.01|-226.93|||GEE|||Week 160||-226.93|-270.01|< 0.0001
71060978|NCT01634048|141629492|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71060979|NCT00725491|141629515|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Whitehead|||||||<0.001
71060980|NCT01495000|141629516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.05|||<|0.0001|TWO_SIDED|95.0|1.91|4.19|||ANCOVA|||||4.19|1.91|<0.0001
71060981|NCT01514461|141629534|SUPERIORITY_OR_OTHER||% change from reference treatment|-28.78||||0.0538|TWO_SIDED|95.0|-55.69|14.46|||Mixed Models Analysis|Mixed Model of Repeated Measurements||||14.46|-55.69|0.0538
71060982|NCT01514461|141629534|SUPERIORITY_OR_OTHER||% change from reference treatment|-40.88||||0.0182|TWO_SIDED|95.0|-63.99|-2.94|||Mixed Models Analysis|Mixed Model of Repeated Measurements||||-2.94|-63.99|0.0182
71060983|NCT02058069|141629585|NON_INFERIORITY_OR_EQUIVALENCE|The Alternative Hypothesis: The Investigational Device (RIO) true event rate is non-inferior to 0.066 (event rate for manual TKA) with a non-inferiority margin of 0.06. The 0.066 rate is based on literature and 0.06 was determined in consultation with FDA.|Rare Adverse Event Rate|0.0|||||ONE_SIDED|95.0||0.0331|||||If the upper bound is \<0.126 then the primary composite safety endpoint is met. After the surgeon completed the procedure, at the conclusion of the participant's hospital stay, and 3 months post-operative were used in this single analysis.|||0.0331||
70852389|NCT00966875|141193440|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
71060984|NCT02058069|141629587|OTHER|The analysis was performed using standard OC curves generated using Sample Size Analyzer® version 2.0 by Taylor Enterprise Inc. (Dr. Wayne A. Taylor).|Alignment Difference <4.38 Degrees|1.0|||||ONE_SIDED|95.0|0.966||||||Estimation Parameter is: proportion of participants with limb alignment difference \<4.38 degrees If the lower bound is \>0.95 then the assessment passes.||||0.966|
71060985|NCT02058069|141629588|NON_INFERIORITY|The upper bound for the one-sided 95% confidence interval will be compared with -9. If the upper bound is less than -9, then non-inferiority holds.|Mean Difference (Final Values)|-33.1|||<|0.001|ONE_SIDED|95.0||-29.6|||t-test, 2 sided||If the upper bound is less than -9, then non-inferiority holds.|Change from pre-op to 3 months||-29.6||<0.001
71060986|NCT03290378|141629597|SUPERIORITY||||||<|0.005|TWO_SIDED|95.0|||||ANCOVA|||||||<.005
71060987|NCT02023983|141629598|OTHER|||||||0.765|||||||Fisher Exact|||||||0.765
71060988|NCT02023983|141629599|OTHER|||||||1|||||||Fisher Exact|||||||1
71060989|NCT01288807|141629622|OTHER|repeated measure ANOVA|||||<|0.01|||||||ANOVA|||||||< 0.01
71060990|NCT01288807|141629623|OTHER|two-tailed paired t-test|||||<|0.05|||||||t-test, 2 sided|||This analysis looks at the cold threshold measured in degrees celcius before and after treatment.||||< 0.05
71060991|NCT01288807|141629624|OTHER||||||>|0.05|||||||t-test, 2 sided|||This analysis looks at the pressure threshold measured in pounds per square inch before and after treatment||||> 0.05
71060992|NCT01288807|141629625|OTHER||||||>|0.05||||||one-way repeated measure ANOVA|ANOVA|||||||> 0.05
71060993|NCT01422200|141629627|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
71060994|NCT02015611|141629650|SUPERIORITY|||||||0.63|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.63
71060995|NCT02015611|141629651|SUPERIORITY|||||||0.64|||||||Regression, Linear|adjusted for age, sex, race, season, and baseline value||||||0.64
71060996|NCT02015611|141629652|SUPERIORITY|||||||0.08|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.08
71060997|NCT02015611|141629653|SUPERIORITY|||||||0.53|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.53
71060998|NCT02015611|141629654|SUPERIORITY|||||||0.75|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.75
71060999|NCT02015611|141629655|SUPERIORITY|||||||0.92|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.92
71117640|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
70936693|NCT00824850|141373417|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.56|||||TWO_SIDED|95.0|1.3|1.86|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1.86|1.30|
70936694|NCT00824850|141373417|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.93|||||TWO_SIDED|95.0|1.43|2.6|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.60|1.43|
70936695|NCT00824850|141373417|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.46|||||TWO_SIDED|95.0|3.09|6.45|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||6.45|3.09|
71061000|NCT02015611|141629656|SUPERIORITY|||||||0.94|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.94
71061001|NCT02015611|141629657|SUPERIORITY|||||||0.61|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.61
71061002|NCT02015611|141629658|SUPERIORITY|||||||0.59|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.59
71061003|NCT02015611|141629659|SUPERIORITY|||||||0.21|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.21
71061004|NCT03737357|141629661|NON_INFERIORITY|The tolerance range or non-inferiority margin characterizes the largest absolute difference which is considered to be dismissible. A MBL of less than 0.5mm within the first year after implant loading constitutes an acceptable clinical standard(10, 18, 19). In this clinical trial, a non-inferiority margin of 20% of the acceptable clinical standard was chosen, which amounts to 0.1mm.|paired difference|0.01||||0.074|TWO_SIDED||||||t-test, 1 sided|Non-inferiority one-sided paired t-tests using a non-inferiority margin of -0.10mm.|The paired difference is (SLActive® bone level change from baseline (CFB) - SLA® CFB (i.e. resorption))||In the PP population, the paired difference between SLActive® and SLA® bone level change from baseline (CFB) was estimated at 0.01 mm with a standard deviation of 0.444 mm (95% CI: -Inf, 0.11; p = 0.074), based on a one-sided paired t-test with a non-inferiority margin of 0.10 mm.|||0.074
71061005|NCT01320293|141629671|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 1 sided|||Null hypothesis: Percent change in endothelial function from baseline visit to end of treatment/month 6 will be zero change. (percent change=0)||||<0.05
71061006|NCT01320293|141629672|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 1 sided|||Null hypothesis: change in IL-6 levels from baseline visit to end of treatment/month 6 will be zero change. (percent change=0)||||<0.05
71061007|NCT01320293|141629673|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 1 sided|||Null hypothesis: change in adiponectin levels from baseline visit to end of treatment/month 6 will be zero change. (percent change=0)||||0.05
71061008|NCT00793455|141629679|SUPERIORITY_OR_OTHER||Rate Ratio|3.1|||<|0.05|TWO_SIDED|95.0|1.5|6.2|||Chi-squared|||We compared the outcomes in the intervention and control groups using rate ratios and chi square test at 3 and 6 months, a 2 sided test with a p value \< .05 was used to determine significance. The study was powered to detect a 10-percentage point difference in screening completion between intervention and control groups if the control rate of completion as 20% or less with 80% power.||6.2|1.5|<0.05
71061009|NCT00793455|141629680|SUPERIORITY_OR_OTHER||Rate Ratio|1.5|||<|0.05|TWO_SIDED|95.0|1.03|2.2|||Chi-squared|||Same as primary outcome.||2.2|1.03|<0.05
71061010|NCT04782076|141629684|OTHER||LS Mean Difference (Final Values)|1.43|||||TWO_SIDED|90.0|1.33|1.55|||Mixed Models Analysis|Least Squares Mean (LS Mean)||||1.55|1.33|
71061011|NCT04782076|141629685|OTHER||LS Mean Difference (Final Values)|1.38|||||TWO_SIDED|90.0|1.3|1.46|||Mixed Models Analysis|||||1.46|1.30|
71061012|NCT04910100|141629689|NON_INFERIORITY|To demonstrate noninferiority, the upper limits of the 2-sided 95% confidence interval for the difference between each comparison must be lower than 1.5 mmHg at all timepoints and lower than 1.0 mmHg for the majority of the timepoints (i.e. at least 5 of 9). This was a Phase 2 study and so the sample size was not based on a formal sample size calculation. The study was planned to provide sufficient data to power a Phase 3 study.|Timepoints with Mean IOP < 1.5 mm Hg|6.0|||||TWO_SIDED|||||||||The primary efficacy analysis was the between group comparison of the mean IOP values in the study eye at each time point at each visit (a total of 9 between-group comparisons). A hierarchical analysis was conducted to compare each of the investigational products against the comparator, timolol 0.5% as follows: (1) Timolol Suspensions 0.5% (2) Nebivolol Suspension 1% (3) Nebivolol Suspension 0.5%.||||
71078024|NCT01026818|141664566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.675|TWO_SIDED|95.0|0.63|2.06||The Type I error was controlled for multiplicity using a Bonferroni-Hommel procedure. First the largest p-value for the odds ratio to placebo was tested at the 5% level and in case of no rejection the second p-value was tested at the 2.5% level.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.||A sample size of 412 randomized participants provided 84% power to detect a 20% difference in the proportions for the 3 treatment groups. The sample size allowed for a 20% withdrawal during the study.||2.06|0.63|0.675
70941730|NCT04748445|141383935|OTHER||Slope|-5.254|STANDARD_ERROR_OF_MEAN|4.217||0.901|TWO_SIDED|90.0|-7.513|6.463|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 07 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-4. For estimated value it was 10\^-5).||6.463|-7.513|0.9010
70936696|NCT00824850|141373417|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.32|||||TWO_SIDED|95.0|3.65|7.75|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||7.75|3.65|
71061013|NCT04910100|141629689|NON_INFERIORITY|To demonstrate noninferiority, the upper limits of the 2-sided 95% confidence interval for the difference between each comparison must be lower than 1.5 mmHg at all timepoints and lower than 1.0 mmHg for the majority of the timepoints (i.e. at least 5 of 9). This was a Phase 2 study and so the sample size was not based on a formal sample size calculation. The study was planned to provide sufficient data to power a Phase 3 study.|Timepoints with Mean IOP < 1.0 mm Hg|9.0|||||TWO_SIDED|||||||||The primary efficacy analysis was the between group comparison of the mean IOP values in the study eye at each time point at each visit (a total of 9 between-group comparisons). A hierarchical analysis was conducted to compare each of the investigational products against the comparator, timolol 0.5% as follows: (1) Timolol Suspensions 0.5% (2) Nebivolol Suspension 1% (3) Nebivolol Suspension 0.5%.||||
71061014|NCT04910100|141629689|NON_INFERIORITY|To demonstrate noninferiority, the upper limits of the 2-sided 95% confidence interval for the difference between each comparison must be lower than 1.5 mmHg at all timepoints and lower than 1.0 mmHg for the majority of the timepoints (i.e. at least 5 of 9). This was a Phase 2 study and so the sample size was not based on a formal sample size calculation. The study was planned to provide sufficient data to power a Phase 3 study.|Timepoints with Mean IOP < 1.5 mm Hg|0.0|||||TWO_SIDED|||||||||The primary efficacy analysis was the between group comparison of the mean IOP values in the study eye at each time point at each visit (a total of 9 between-group comparisons). A hierarchical analysis was conducted to compare each of the investigational products against the comparator, timolol 0.5% as follows: (1) Timolol Suspensions 0.5% (2) Nebivolol Suspension 1% (3) Nebivolol Suspension 0.5%.||||
71061015|NCT04910100|141629689|NON_INFERIORITY|To demonstrate noninferiority, the upper limits of the 2-sided 95% confidence interval for the difference between each comparison must be lower than 1.5 mmHg at all timepoints and lower than 1.0 mmHg for the majority of the timepoints (i.e. at least 5 of 9). This was a Phase 2 study and so the sample size was not based on a formal sample size calculation. The study was planned to provide sufficient data to power a Phase 3 study.|Timepoints with Mean IOP < 1.0 mm Hg|0.0|||||TWO_SIDED|||||||||The primary efficacy analysis was the between group comparison of the mean IOP values in the study eye at each time point at each visit (a total of 9 between-group comparisons). A hierarchical analysis was conducted to compare each of the investigational products against the comparator, timolol 0.5% as follows: (1) Timolol Suspensions 0.5% (2) Nebivolol Suspension 1% (3) Nebivolol Suspension 0.5%.||||
71110010|NCT04067492|141725342|OTHER|"The study was planned to randomize 85 patients: 15 patients in the RPH-104 4 mg group, and 14 patients in the RPH-104 20 mg, 40 mg, 80 mg and 160 mg groups each, a total of 14 patients in the Voltaren® (diclofenac) group.~The sample size was calculated assuming a standard deviation of 26 mm for change in pain intensity at 72 hours."|Mean Difference (Final Values)|-2.05||||0.1331|TWO_SIDED|95.0|-30.6|26.5||p-value, group|ANCOVA||Adjusted mean difference. Comparison with the control group \[RPH-104 - Diclofenac\].|It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.||26.50|-30.60|0.1331
71110011|NCT04067492|141725342|OTHER|"The study was planned to randomize 85 patients: 15 patients in the RPH-104 4 mg group, and 14 patients in the RPH-104 20 mg, 40 mg, 80 mg and 160 mg groups each, a total of 14 patients in the Voltaren® (diclofenac) group.~The sample size was calculated assuming a standard deviation of 26 mm for change in pain intensity at 72 hours."|Mean Difference (Final Values)|16.7||||0.1331|TWO_SIDED|95.0|-12.67|46.08||p-value, group|ANCOVA||Adjusted mean difference. Comparison with the control group \[RPH-104 - Diclofenac\].|It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.||46.08|-12.67|0.1331
71110012|NCT04067492|141725342|OTHER|"The study was planned to randomize 85 patients: 15 patients in the RPH-104 4 mg group, and 14 patients in the RPH-104 20 mg, 40 mg, 80 mg and 160 mg groups each, a total of 14 patients in the Voltaren® (diclofenac) group.~The sample size was calculated assuming a standard deviation of 26 mm for change in pain intensity at 72 hours."|Mean Difference (Final Values)|3.12||||0.1331|TWO_SIDED|95.0|-25.1|31.33||p-value, group|ANCOVA||Adjusted mean difference. Comparison with the control group \[RPH-104 - Diclofenac\]|It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.||31.33|-25.10|0.1331
70936697|NCT00824850|141373417|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.27|||||TWO_SIDED|95.0|2.49|4.28|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||4.28|2.49|
70936698|NCT00824850|141373418|SUPERIORITY_OR_OTHER||geometric mean fold rise|15.86|||||TWO_SIDED|95.0|9.16|27.46|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||27.46|9.16|
70936699|NCT00824850|141373418|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.01|||||TWO_SIDED|95.0|3.5|7.16|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||7.16|3.50|
70936700|NCT00824850|141373418|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.86|||||TWO_SIDED|95.0|2.93|5.09|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||5.09|2.93|
71061016|NCT04910100|141629689|NON_INFERIORITY|To demonstrate noninferiority, the upper limits of the 2-sided 95% confidence interval for the difference between each comparison must be lower than 1.5 mmHg at all timepoints and lower than 1.0 mmHg for the majority of the timepoints (i.e. at least 5 of 9). This was a Phase 2 study and so the sample size was not based on a formal sample size calculation. The study was planned to provide sufficient data to power a Phase 3 study.|Timepoints with Mean IOP < 1.5 mm Hg|0.0|||||TWO_SIDED|||||||||The primary efficacy analysis was the between group comparison of the mean IOP values in the study eye at each time point at each visit (a total of 9 between-group comparisons). A hierarchical analysis was conducted to compare each of the investigational products against the comparator, timolol 0.5% as follows: (1) Timolol Suspensions 0.5% (2) Nebivolol Suspension 1% (3) Nebivolol Suspension 0.5%.||||
71061017|NCT04910100|141629689|NON_INFERIORITY|To demonstrate noninferiority, the upper limits of the 2-sided 95% confidence interval for the difference between each comparison must be lower than 1.5 mmHg at all timepoints and lower than 1.0 mmHg for the majority of the timepoints (i.e. at least 5 of 9). This was a Phase 2 study and so the sample size was not based on a formal sample size calculation. The study was planned to provide sufficient data to power a Phase 3 study.|Timepoints with Mean IOP < 1.0 mm Hg|0.0|||||TWO_SIDED|||||||||The primary efficacy analysis was the between group comparison of the mean IOP values in the study eye at each time point at each visit (a total of 9 between-group comparisons). A hierarchical analysis was conducted to compare each of the investigational products against the comparator, timolol 0.5% as follows: (1) Timolol Suspensions 0.5% (2) Nebivolol Suspension 1% (3) Nebivolol Suspension 0.5%.||||
71061018|NCT07034820|141629696|SUPERIORITY||Risk Difference (RD)|56.0|||<|0.001|TWO_SIDED|95.0|48.0|64.0||A priori statistical significance threshold for the primary endpoint was set at a two-sided alpha level of 0.05. No adjustment for multiple comparisons was applied to the primary outcome analysis, as it was the sole primary endpoint.|Chi-squared||The Risk Difference (RD) indicates the absolute difference in hemorrhoid regression rates between the Nimsai Herbal Group and the Placebo Group. Calculation: Nimsai Herbal (78%) - Placebo (22%) = 56%.|Powered for 56% difference (80% power, alpha=0.05) to detect the anticipated difference in hemorrhoid regression rates between groups. The sample size of N=300 (150 participants per arm) was calculated based on an expected regression rate of 22% in the placebo group and 78% in the Nimsai Herbal group. This ensured sufficient statistical power for the primary efficacy analysis.||64|48|<0.001
71061019|NCT03787134|141629752|SUPERIORITY|||||||0.335|||||||t-test, 2 sided|||cued memory item reconstruction - test of reconstruction strength against 0||||.335
71061020|NCT03787134|141629752|SUPERIORITY|||||||0.016|||||||t-test, 2 sided|||uncued memory item reconstruction - test of reconstruction strength against 0||||.016
71061021|NCT02586155|141629773|SUPERIORITY||Cox Proportional Hazard|0.823||||0.107|TWO_SIDED|95.0|0.649|1.044|||Stratified long-rank|||||1.044|0.649|0.1070
71061022|NCT02586155|141629774|SUPERIORITY||Cox Proportional Hazard|0.849||||0.1495|TWO_SIDED|95.0|0.679|1.061|||Stratified long-rank|||||1.061|0.679|0.1495
71061023|NCT02586155|141629775|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.03|TWO_SIDED|95.0|0.38|0.94|||Stratified long-rank|||||0.94|0.38|0.03
71061024|NCT02586155|141629776|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.44|TWO_SIDED|95.0|0.62|1.24|||Stratified long-rank|||||1.24|0.62|0.44
71061025|NCT02586155|141629787|SUPERIORITY||Cox Proportional Hazard|0.78||||0.03|TWO_SIDED|95.0|0.63|0.98|||Log Rank|||||0.98|0.63|0.03
71061026|NCT04779879|141629792|OTHER||Ratio of geometric least squares mean|1.04|||||TWO_SIDED|90.0|0.98|1.09|||||Analysis was performed using an Analysis of covariance (ANCOVA) model with covariates of treatment and Baseline logarithm (base 10) viral load.|||1.09|0.98|
70936701|NCT00824850|141373418|SUPERIORITY_OR_OTHER||geometric mean fold rise|17.57|||||TWO_SIDED|95.0|11.11|27.79|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||27.79|11.11|
71061027|NCT04779879|141629793|OTHER||Ratio of geometric least squares mean|1.02|||||TWO_SIDED|90.0|0.94|1.11|||||Analysis was performed using an ANCOVA model with covariates of treatment, and Baseline logarithm (base10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).|||1.11|0.94|
71061028|NCT04779879|141629822|OTHER||Ratio of geometric least squares mean|1.05|||||TWO_SIDED|90.0|1.0|1.11|||||Analysis was performed using an ANCOVA model with covariates of treatment and Baseline logarithm (base 10) viral load.|||1.11|1.00|
71061029|NCT04779879|141629823|OTHER||Ratio of geometric least squares mean|1.02|||||TWO_SIDED|90.0|0.97|1.07|||||Analysis was performed using an ANCOVA model with covariates of treatment and Baseline logarithm (base 10) viral load.|||1.07|0.97|
70936702|NCT00824850|141373418|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.22|||||TWO_SIDED|95.0|2.86|6.23|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||6.23|2.86|
70936703|NCT00824850|141373418|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.54|||||TWO_SIDED|95.0|1.78|3.62|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||3.62|1.78|
70936704|NCT00824850|141373418|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.21|||||TWO_SIDED|95.0|2.86|6.19|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||6.19|2.86|
70936705|NCT00824850|141373418|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.23|||||TWO_SIDED|95.0|2.79|6.42|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||6.42|2.79|
70936706|NCT00824850|141373418|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.63|||||TWO_SIDED|95.0|1.3|2.05|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.05|1.30|
71061030|NCT04779879|141629824|OTHER||Ratio of geometric least squares mean|1.01|||||TWO_SIDED|90.0|0.93|1.09|||||Analysis was performed using an ANCOVA model with covariates of treatment, Baseline logarithm (base 10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).|||1.09|0.93|
71110013|NCT04067492|141725342|OTHER|"The study was planned to randomize 85 patients: 15 patients in the RPH-104 4 mg group, and 14 patients in the RPH-104 20 mg, 40 mg, 80 mg and 160 mg groups each, a total of 14 patients in the Voltaren® (diclofenac) group.~The sample size was calculated assuming a standard deviation of 26 mm for change in pain intensity at 72 hours."|Mean Difference (Final Values)|5.96||||0.1331|TWO_SIDED|95.0|-24.22|36.14||p-value, group|ANCOVA||Adjusted mean difference. Comparison with the control group \[RPH-104 - Diclofenac\].|It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.||36.14|-24.22|0.1331
71110014|NCT04067492|141725349|OTHER|||||||0.5995|||||||Log Rank|||||||0.5995
71110015|NCT04067492|141725349|OTHER|||||||0.9012|||||||Log Rank|||||||0.9012
70852390|NCT00966875|141193440|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
70936707|NCT00824850|141373418|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.67|||||TWO_SIDED|95.0|1.3|2.14|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.14|1.30|
71061031|NCT04779879|141629825|OTHER||Ratio of geometric least squares mean|1.02|||||TWO_SIDED|90.0|0.94|1.1|||||Analysis was performed using an ANCOVA model with covariates of treatment, Baseline logarithm (base 10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).|||1.10|0.94|
71061032|NCT04779879|141629886|OTHER||Ratio of geometric least squares mean|0.66|||||TWO_SIDED|90.0|0.48|0.89|||||Drug bioavailability was analyzed using an ANCOVA model with treatment and weight at Baseline as covariates.|||0.89|0.48|
71110016|NCT04067492|141725351|OTHER||difference in proportions|63.5||||0.0066|TWO_SIDED|95.0|19.9|88.6|||Fisher Exact|||||88.6|19.9|0.0066
71110017|NCT04067492|141725351|OTHER||difference in proportions|-5.6|||>|0.9999|TWO_SIDED|95.0|-50.1|45.5|||Fisher Exact|||||45.5|-50.1|>0.9999
71110018|NCT04067492|141725351|OTHER||difference in proportions|27.8||||0.3287|TWO_SIDED|95.0|-26.8|71.8|||Fisher Exact|||||71.8|-26.8|0.3287
71110019|NCT04067492|141725351|OTHER||difference in proportions|27.8||||0.3287|TWO_SIDED|95.0|-26.8|71.8|||Fisher Exact|||||71.8|-26.8|0.3287
71110020|NCT04067492|141725351|OTHER||difference in proportions|17.8||||0.5804|TWO_SIDED|95.0|-33.7|67.8|||Fisher Exact|||||67.8|-33.7|0.5804
71110021|NCT01646814|141725384|SUPERIORITY|||||||0.019|||||||Chi-squared|||||||0.019
70852391|NCT00966875|141193440|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
71061033|NCT04779879|141629886|OTHER||Ratio of geometric least squares mean|0.58|||||TWO_SIDED|90.0|0.43|0.79|||||Drug bioavailability was analyzed using an ANCOVA model with treatment and weight at Baseline as covariates.|||0.79|0.43|
71061034|NCT04779879|141629887|OTHER||Ratio of geometric least squares mean|1.14|||||TWO_SIDED|90.0|0.67|1.95|||||Dose proportionality was analyzed using an ANOVA model with treatment (250mg, 500mg) as a covariate, for each parameter of interest.|||1.95|0.67|
71061035|NCT04779879|141629888|OTHER||Ratio of geometric least squares mean|1.06|||||TWO_SIDED|90.0|0.69|1.62|||||Dose proportionality was analyzed using an ANOVA model with treatment (250mg, 500mg) as a covariate, for each parameter of interest.|||1.62|0.69|
71061036|NCT04779879|141629889|OTHER||Ratio of geometric least squares mean|1.11|||||TWO_SIDED|90.0|0.68|1.82|||||Dose proportionality was analyzed using an ANOVA model with treatment (250mg, 500mg) as a covariate, for each parameter of interest.|||1.82|0.68|
71061037|NCT04779879|141629890|OTHER||Ratio of geometric least squares mean|1.28|||||TWO_SIDED|90.0|0.77|2.12|||||Dose proportionality was analyzed using an ANOVA model with treatment (250mg, 500mg) as a covariate, for each parameter of interest.|||2.12|0.77|
71061038|NCT00070564|141629933|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.32||||0.022|TWO_SIDED|95.0|1.04|1.68|||Log Rank|||||1.68|1.04|0.022
71061039|NCT00070564|141629933|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.24||||0.072|TWO_SIDED|95.0|0.98|1.59|||Log Rank|||||1.59|0.98|0.072
71061040|NCT00070564|141629933|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.12||||0.38|TWO_SIDED|95.0|0.87|1.44|||Log Rank|||||1.44|0.87|0.38
71061041|NCT00070564|141629933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11|||||||Log Rank|||||||0.11
71061042|NCT00070564|141629933|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.733|TWO_SIDED|95.0|0.61|1.41|||Log Rank|||||1.41|0.61|0.733
71061043|NCT00070564|141629934|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.44||||0.013|TWO_SIDED|95.0|1.08|1.93|||Log Rank|||||1.93|1.08|0.013
71061044|NCT00070564|141629934|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.46||||0.011|TWO_SIDED|95.0|1.09|1.95|||Log Rank|||||1.95|1.09|0.011
71061045|NCT00070564|141629934|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.24||||0.17|TWO_SIDED|95.0|0.91|1.68|||Log Rank|||||1.68|0.91|0.17
70852392|NCT00966875|141193440|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
70852393|NCT00966875|141193440|SUPERIORITY_OR_OTHER|||||||0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.001
70852394|NCT00966875|141193442|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||P-value is for Week 12 LOCF.|Fisher Exact|||||||0.013
70852395|NCT00966875|141193442|SUPERIORITY_OR_OTHER|||||||0.076|TWO_SIDED|||||P-value is for Week 12 LOCF.|Fisher Exact|||||||0.076
70852396|NCT00966875|141193442|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||P-value is for Week 12 LOCF.|Fisher Exact|||||||0.002
71061046|NCT00070564|141629934|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|||||||Log Rank|||||||0.040
71061047|NCT00070564|141629934|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.724|TWO_SIDED|95.0|0.54|1.53|||Log Rank|||||1.53|0.54|0.724
71061048|NCT00070564|141629936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.67|||||||Log Rank|||Overall treatment differences.||||0.67
71061049|NCT00070564|141629936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.42|||||||Log Rank|||Test of interaction of two treatments: AC and paclitaxel.||||0.42
71061050|NCT00070564|141629937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|||||||Log Rank|||Test of overall treatment differences.||||0.90
71061051|NCT00070564|141629937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.52|||||||Log Rank|||Test of interaction of two treatments: AC and paclitaxel.||||0.52
71061052|NCT00070564|141629938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.076|||||||Log Rank|||Test of overall treatment differences.||||0.076
71061053|NCT00070564|141629938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||Log Rank|||Test of interaction of two treatments: AC and paclitaxel.||||0.018
71061054|NCT00070564|141629939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062|||||||Log Rank|||Test of overall treatment differences.||||0.062
71061055|NCT00070564|141629939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||Log Rank|||Test of interaction of two treatments: AC and paclitaxel.||||0.010
71061056|NCT00070564|141629940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69|||||||Log Rank|||Test of overall treatment differences.||||0.69
71061057|NCT00070564|141629940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|||||||Log Rank|||Test of interaction two treatments: AC and paclitaxel.||||0.66
71061058|NCT00070564|141629941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|||||||Log Rank|||Test of overall treatment differences||||0.40
71061059|NCT00070564|141629941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28|||||||Log Rank|||Test of interaction of two treatments: AC and paclitaxel.||||0.28
71061060|NCT02059512|141629942|SUPERIORITY|||||||0.24|||||||Kruskal-Wallis|||||||0.24
71061061|NCT02059512|141629943|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||Length of hospital stay.||||0.1
71061062|NCT02059512|141629943|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||Length of stay in the intensive care unit.||||0.1
71061063|NCT02059512|141629944|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||||||0.4
71061064|NCT02059512|141629944|SUPERIORITY|||||||0.8|||||||Kruskal-Wallis|||Analysis of leukocytes 0-6 hours of the postoperative period.||||0.8
71061065|NCT02059512|141629944|SUPERIORITY|||||||0.9|||||||Kruskal-Wallis|||Analysis of leukocytes 12-18 hours of the postoperative period.||||0.9
71061066|NCT02059512|141629944|SUPERIORITY|||||||0.2|||||||Kruskal-Wallis|||Analysis of leukocytes 18-24 hours of the postoperative period.||||0.2
71061067|NCT02059512|141629944|SUPERIORITY|||||||0.5|||||||Kruskal-Wallis|||Analysis of leukocytes 48 hours of the postoperative period.||||0.5
71061068|NCT02059512|141629944|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||Analysis of leukocytes 72 hours of the postoperative period.||||0.4
71061069|NCT02059512|141629944|SUPERIORITY|||||||0.6|||||||Kruskal-Wallis|||Analysis of leukocytes 96 hours of the postoperative period/||||0.6
71061070|NCT02059512|141629944|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||Analysis of leukocytes 7 days of the postoperative period.||||0.4
71061071|NCT02059512|141629944|SUPERIORITY|||||||0.5|||||||Kruskal-Wallis|||Analysis of leukocytes 14 days of the postoperative period.||||0.5
71061072|NCT02059512|141629945|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||CRP initially.||||0.1
71061073|NCT02059512|141629945|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||CRP postoperative 4-6 days.||||0.4
71061074|NCT02059512|141629945|SUPERIORITY|||||||0.99|||||||Kruskal-Wallis|||CRP postoperative 12-14 days.||||0.99
71061075|NCT02059512|141629946|SUPERIORITY|||||||0.2|||||||Kruskal-Wallis|||The volume of discharge through the drains on the first day after surgery.||||0.2
71061076|NCT02059512|141629946|SUPERIORITY|||||||0.3|||||||RepeatedMeasures ANOVA|||The volume of discharge through the drains on the second day after the operation.||||0.3
71061077|NCT02059512|141629947|SUPERIORITY|||||||0.6|||||||Kruskal-Wallis|||Troponin I postoperative day 1.||||0.6
71061078|NCT02059512|141629947|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||Troponin I postoperative day 3.||||0.4
71061079|NCT02059512|141629947|SUPERIORITY|||||||0.8|||||||Kruskal-Wallis|||Myoglobin postoperative day 1.||||0.8
70852397|NCT00966875|141193442|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12 LOCF.|Fisher Exact|||||||<0.001
70852398|NCT00966875|141193442|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||P-value is for Week 12.|Fisher Exact|||||||0.002
70852399|NCT00966875|141193442|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||P-value is for Week 12 LOCF.|Fisher Exact|||||||0.006
70852400|NCT00966875|141193442|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value is for Week 12.|Fisher Exact|||||||0.001
71061080|NCT02059512|141629947|SUPERIORITY|||||||0.7|||||||Kruskal-Wallis|||Myoglobin postoperative day 3.||||0.7
71061081|NCT02059512|141629948|SUPERIORITY|||||||0.7|||||||Kruskal-Wallis|||CPK-MB postoperative day 1.||||0.7
71061082|NCT02059512|141629948|SUPERIORITY|||||||0.8|||||||Kruskal-Wallis|||CPK-MB postoperative day 3.||||0.8
71061083|NCT02059512|141629949|SUPERIORITY|||||||1|||||||Kruskal-Wallis|||Hb intraoperatively before turning off the cardiopulmonary bypass(CPB).||||1.0
71061084|NCT02059512|141629949|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||Hb at the end of the operation.||||0.4
70852401|NCT00966875|141193444|SUPERIORITY_OR_OTHER|||||||0.307||||||P-value is for Week 12.|ANCOVA|||||||0.307
70852402|NCT00966875|141193444|SUPERIORITY_OR_OTHER|||||||0.104||||||P-value is for Week 12.|ANCOVA|||||||0.104
70852403|NCT00966875|141193444|SUPERIORITY_OR_OTHER|||||||0.139||||||P-value is for Week 12.|ANCOVA|||||||0.139
70852404|NCT00966875|141193444|SUPERIORITY_OR_OTHER|||||||0.056||||||P-value is for Week 12.|ANCOVA|||||||0.056
70852405|NCT00966875|141193444|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED|||||P-value is for Week 12.|ANCOVA|||||||0.048
70852406|NCT00966875|141193444|SUPERIORITY_OR_OTHER|||||||0.16||||||P-value is for Week 12.|ANCOVA|||||||0.160
70852407|NCT00966875|141193444|SUPERIORITY_OR_OTHER|||||||0.029||||||P-value is for Week 12.|ANCOVA|||||||0.029
70852408|NCT00966875|141193446|SUPERIORITY_OR_OTHER|||||||0.272||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.272
70852409|NCT00966875|141193446|SUPERIORITY_OR_OTHER|||||||0.962||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.962
71061085|NCT02059512|141629950|SUPERIORITY|||||||0.8|||||||Kruskal-Wallis|||HCT intraoperatively before turning off the cardiopulmonary bypass (CPB).||||0.8
71061086|NCT02059512|141629950|SUPERIORITY|||||||0.3|||||||Kruskal-Wallis|||HCT at the end of the operation.||||0.3
71061087|NCT02059512|141629951|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||K+ intraoperatively before turning off the cardiopulmonary bypass (CPB).||||0.4
71061088|NCT02059512|141629951|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||K+ at the end of the operation.||||0.1
71061089|NCT02059512|141629952|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||||||0.1
71061090|NCT02059512|141629953|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||||||0.1
71061091|NCT02059512|141629954|SUPERIORITY|||||||0.6|||||||Chi-squared|||Hydrothorax / postoperative period.||||0.6
71061092|NCT02059512|141629954|SUPERIORITY|||||||0.2|||||||Chi-squared|||Hydropericardium / postoperative period.||||0.2
71061093|NCT02059512|141629954|SUPERIORITY|||||||0.6|||||||Chi-squared|||Resternotomy / postoperative period.||||0.6
71061094|NCT02059512|141629954|SUPERIORITY|||||||0.06|||||||Chi-squared|||Atrial fibrillation / postoperative period.||||0.06
71061095|NCT02059512|141629954|SUPERIORITY|||||||0.06|||||||Chi-squared|||Atrial flutter / postoperative period.||||0.06
71061096|NCT02059512|141629955|SUPERIORITY|||||||0.4|||||||RepeatedMeasures ANOVA|||||||0.4
71061097|NCT02059512|141629956|SUPERIORITY|||||||0.5|||||||RepeatedMeasures ANOVA|||Lvd ind. (Lvd mm./BSA kg / cm) - Evaluation of the left ventricular end-diastolic size index.||||0.5
71061098|NCT02059512|141629956|SUPERIORITY|||||||0.5|||||||RepeatedMeasures ANOVA|||Lvs ind. (Lvs mm./BSA kg / cm) - Evaluation of the left ventricular end-systolic size index.||||0.5
71061099|NCT02059512|141629956|SUPERIORITY|||||||0.6|||||||RepeatedMeasures ANOVA|||LAind. (LA mm./BSA kg / cm) - Left Atrial Size Index Assessment.||||0.6
71061100|NCT02059512|141629957|SUPERIORITY|||||||0.4|||||||RepeatedMeasures ANOVA|||LVEDV MOD BP ind. (LVEDV MOD BP ml./BSA kg / cm) - Evaluation of the left ventricular end-diastolic volume index.||||0.4
71061101|NCT02059512|141629957|SUPERIORITY|||||||0.3|||||||RepeatedMeasures ANOVA|||Evaluation of the left ventricular end-systolic volume index (LVESV MOD BP ind.)||||0.3
71061102|NCT02059512|141629958|SUPERIORITY|||||||0.6|||||||Chi-squared|||||||0.6
71061103|NCT02059512|141629960|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||Physical Functioning SF-36. Comparison of patients of group 1 and group 2 with the control group - group 0.||||0.7
71061104|NCT02059512|141629960|SUPERIORITY|||||||0.8|||||||RepeatedMeasures ANOVA|||Role-Physical Functioning SF-36||||0.8
71061105|NCT02059512|141629960|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||Bodily pain SF-36||||0.7
71061106|NCT02059512|141629960|SUPERIORITY|||||||0.6|||||||RepeatedMeasures ANOVA|||General Health SF-36.||||0.6
71061107|NCT02059512|141629960|SUPERIORITY|||||||0.8|||||||RepeatedMeasures ANOVA|||Vitality SF-36.||||0.8
71061108|NCT02059512|141629960|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||Social Functioning SF-36.||||0.7
71061109|NCT02059512|141629960|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||Role- Emotional SF-36.||||0.7
71061110|NCT02059512|141629960|SUPERIORITY|||||||0.96|||||||RepeatedMeasures ANOVA|||Mental Health SF-36.||||0.96
71061111|NCT02059512|141629960|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||Minnesota Quality of Life (MHFLQ).||||0.7
71061112|NCT02059512|141629960|SUPERIORITY|||||||0.6|||||||RepeatedMeasures ANOVA|||Seattle QuestionnairePhysical limitation.||||0.6
71061113|NCT02059512|141629960|SUPERIORITY|||||||0.4|||||||RepeatedMeasures ANOVA|||SeattleQuestionnaireAngina stability.||||0.4
71061114|NCT02059512|141629960|SUPERIORITY|||||||0.6|||||||RepeatedMeasures ANOVA|||SeattleQuestionnaireAngina frequency.||||0.6
71061115|NCT02059512|141629960|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||SeattleQuestionnaireTreatment satisfaction.||||0.7
71061116|NCT02059512|141629960|SUPERIORITY|||||||0.3|||||||RepeatedMeasures ANOVA|||SeattleQuestionnaire Disease perception.||||0.3
71061117|NCT02059512|141629961|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
71061118|NCT02059512|141629962|SUPERIORITY|||||||0.13|||||||Chi-squared|||||||0.13
71061119|NCT02059512|141629963|SUPERIORITY|||||||0.35|||||||RepeatedMeasures ANOVA|||||||0.35
71061120|NCT02059512|141629964|SUPERIORITY|||||||0.2|||||||RepeatedMeasures ANOVA|||Lvd ind. (Lvd mm./BSA) - left ventricular end-diastolic size index. All patients included in the study.||||0.2
71061121|NCT02059512|141629964|SUPERIORITY|||||||0.2|||||||RepeatedMeasures ANOVA|||Lvs ind. (Lvs mm./BSA kg / cm) - left ventricular end-systolic size index.||||0.2
71061122|NCT02059512|141629964|SUPERIORITY|||||||0.5|||||||RepeatedMeasures ANOVA|||LAind. (LA mm./BSA kg / cm) - left atrial index.||||0.5
71061123|NCT02059512|141629965|SUPERIORITY|||||||0.6|||||||RepeatedMeasures ANOVA|||LVEDV MOD BP ind. (LVEDV MOD BP ml./BSA kg / cm) - left ventricular end-diastolic volume index.||||0.6
71061124|NCT02059512|141629965|SUPERIORITY|||||||0.2|||||||RepeatedMeasures ANOVA|||LVESV MOD BP ind. (LVESV MOD BP ml./BSA kg / cm) - left ventricular end-systolic volume index.||||0.2
71061125|NCT02059512|141629966|SUPERIORITY|||||||0.35|||||||RepeatedMeasures ANOVA|||Peak E of transmitral flow||||0.35
71061126|NCT02059512|141629966|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||Peak A of transmitral flow.||||0.7
71061127|NCT02059512|141629967|SUPERIORITY|||||||0.5|||||||RepeatedMeasures ANOVA|||Peak E of transmitral flow/ Peak A of transmitral flow (E/A).||||0.5
71061128|NCT02059512|141629968|SUPERIORITY|||||||0.9|||||||RepeatedMeasures ANOVA|||DT (Half-time of wave E).||||0.9
71061129|NCT02059512|141629968|SUPERIORITY|||||||0.9|||||||RepeatedMeasures ANOVA|||time of isovolumic relaxation of the left ventricle||||0.9
71061130|NCT02059512|141629969|SUPERIORITY|||||||0.0367|||||||Kruskal-Wallis|||||||0.0367
71061131|NCT02059512|141629970|SUPERIORITY|||||||0.04|||||||Chi-squared|||Assessment of the functioning of grafts. Patency of grafts within a specified time of treatment (angiography).||||0.04
71061132|NCT02059512|141629971|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
71061133|NCT02059512|141629972|SUPERIORITY|||||||0.05|||||||Discriminant Analysis|||||||0.05
71061134|NCT02059512|141629973|SUPERIORITY|||||||0.05|||||||Discriminant Analysis|Data were analyzed by 1, 2, and 3 sections according to the study design.||Mononuclear fraction %||||0.05
71061135|NCT02059512|141629973|SUPERIORITY|||||||0.057|||||||Discriminant Analysis|Data were analyzed by 1, 2, and 3 sections according to the study design.||CD34+ %||||0.057
71061136|NCT02059512|141629973|SUPERIORITY|||||||0.05|||||||Discriminant Analysis|||CD133+ %||||0.05
71061137|NCT02059512|141629974|SUPERIORITY|||||||0.046|||||||Factor analysis|||Factor analysis - determining the influence of a factor, in this case, smoking, on the deficit in the number of meters passed according to the test with a 6-minute walk.||||0.046
71061138|NCT03848715|141629997|SUPERIORITY|||||||0.16|||||||Regression, Linear|||||||.16
71061139|NCT01038336|141630024|SUPERIORITY_OR_OTHER|||||||0.289|TWO_SIDED||||||Chi-squared|||||||0.289
70936708|NCT00824850|141373418|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.6|||||TWO_SIDED|95.0|2.39|5.42|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||5.42|2.39|
70936709|NCT00824850|141373418|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.41|||||TWO_SIDED|95.0|2.42|4.82|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||4.82|2.42|
70936710|NCT00824850|141373418|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.6|2.26|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.26|1.60|
71061140|NCT01038336|141630025|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||ANOVA|||||||0.004
71061141|NCT01038336|141630026|SUPERIORITY_OR_OTHER|||||||0.072|TWO_SIDED||||||ANOVA|||||||0.072
71061142|NCT01038336|141630027|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||ANOVA|||||||0.030
71061143|NCT01038336|141630028|SUPERIORITY_OR_OTHER|||||||0.092|TWO_SIDED||||||ANOVA|||||||0.092
71061144|NCT01038336|141630029|SUPERIORITY_OR_OTHER|||||||0.832|TWO_SIDED||||||ANOVA|||||||0.832
71061145|NCT01038336|141630030|SUPERIORITY_OR_OTHER|||||||0.454|TWO_SIDED||||||ANOVA|||||||0.454
71061146|NCT01038336|141630031|SUPERIORITY_OR_OTHER|||||||0.128|TWO_SIDED||||||ANOVA|||||||0.128
71061147|NCT02763046|141630041|SUPERIORITY||Odds Ratio (OR)|1.32||||0.3512|TWO_SIDED|95.0|0.74|2.36|||Regression, Logistic|||||2.36|0.74|0.3512
71061148|NCT02763046|141630042|SUPERIORITY||Odds Ratio (OR)|1.33||||0.401|TWO_SIDED|95.0|0.68|2.6|||Regression, Logistic|||Week 12||2.60|0.68|0.4010
71061149|NCT02763046|141630042|SUPERIORITY||Odds Ratio (OR)|1.3||||0.4382|TWO_SIDED|95.0|0.67|2.55|||Regression, Logistic|||Week 12||2.55|0.67|0.4382
71061150|NCT02763046|141630042|SUPERIORITY||Odds Ratio (OR)|1.78||||0.0934|TWO_SIDED|95.0|0.91|3.5|||Regression, Logistic|||Week 16||3.50|0.91|0.0934
71061151|NCT02763046|141630042|SUPERIORITY||Odds Ratio (OR)|1.47||||0.2619|TWO_SIDED|95.0|0.75|2.9|||Regression, Logistic|||Week 16||2.90|0.75|0.2619
70936711|NCT00824850|141373419|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.36|||||TWO_SIDED|95.0|4.5|15.56|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||15.56|4.50|
71061152|NCT02763046|141630043|SUPERIORITY||LS (least square) Mean|-10.29|STANDARD_ERROR_OF_MEAN|6.25||0.0997|TWO_SIDED|95.0|-22.55|1.96|||Mixed Model for Repeated Measures (MMRM)|||||1.96|-22.55|0.0997
71061153|NCT02763046|141630043|SUPERIORITY||LS Mean|-12.3|STANDARD_ERROR_OF_MEAN|7.23||0.0888|TWO_SIDED|95.0|-26.47|1.87|||Mixed Model for Repeated Measures (MMRM)|||||1.87|-26.47|0.0888
71061154|NCT02763046|141630043|SUPERIORITY||LS Mean|-8.29|STANDARD_ERROR_OF_MEAN|7.18||0.2484|TWO_SIDED|95.0|-22.36|5.79|||Mixed Model for Repeated Measures (MMRM)|||||5.79|-22.36|0.2484
71061155|NCT02763046|141630044|SUPERIORITY||LS Mean|-2.06||||0.7735|TWO_SIDED|95.0|-16.11|11.98|||Mixed Model for Repeated Measures (MMRM)|||delayed tapering (W12) vs early tapering (W16)||11.98|-16.11|0.7735
71061156|NCT02763046|141630045|SUPERIORITY||LS Mean|-0.39|STANDARD_ERROR_OF_MEAN|0.3||0.1926|TWO_SIDED|95.0|-0.99|0.2|||Mixed Model for Repeated Measures (MMRM)|||Week 12||0.20|-0.99|0.1926
71061157|NCT02763046|141630045|SUPERIORITY||LS Mean|-0.46|STANDARD_ERROR_OF_MEAN|0.35||0.1914|TWO_SIDED|95.0|-1.14|0.23|||Mixed Model for Repeated Measures (MMRM)|||Week 12||0.23|-1.14|0.1914
71061158|NCT02763046|141630045|SUPERIORITY||LS Mean|-0.33|STANDARD_ERROR_OF_MEAN|0.34||0.3397|TWO_SIDED|95.0|-1.01|0.35|||Mixed Model for Repeated Measures (MMRM)|||Week 12||0.35|-1.01|0.3397
71061159|NCT02763046|141630045|SUPERIORITY||LS Mean|-0.68|STANDARD_ERROR_OF_MEAN|0.33||0.0384|TWO_SIDED|95.0|-1.33|-0.04|||Mixed Model for Repeated Measures (MMRM)|||Week 16||-0.04|-1.33|0.0384
71061160|NCT02763046|141630045|SUPERIORITY||LS Mean|-0.41|STANDARD_ERROR_OF_MEAN|0.33||0.2116|TWO_SIDED|95.0|-1.05|0.23|||Mixed Model for Repeated Measures (MMRM)|||Week 16||0.23|-1.05|0.2116
71061161|NCT02763046|141630046|SUPERIORITY||LS Mean|0.63|STANDARD_ERROR_OF_MEAN|1.02||0.5384|TWO_SIDED|95.0|-1.38|2.63|||Mixed Model for Repeated Measures (MMRM)|||||2.63|-1.38|0.5384
71061162|NCT02763046|141630046|SUPERIORITY||LS Mean|-0.11|STANDARD_ERROR_OF_MEAN|1.18||0.9251|TWO_SIDED|95.0|-2.43|2.21|||Mixed Model for Repeated Measures (MMRM)|||||2.21|-2.43|0.9251
71061163|NCT02763046|141630046|SUPERIORITY||LS Mean|1.36|STANDARD_ERROR_OF_MEAN|1.16||0.2432|TWO_SIDED|95.0|-0.93|3.66|||Mixed Model for Repeated Measures (MMRM)|||||3.66|-0.93|0.2432
71061164|NCT03052751|141630054|SUPERIORITY||LS Mean Difference vs Placebo|-0.7|||=|0.221|ONE_SIDED|95.0||0.8||One-sided p-value was presented for difference.|MMRM||Estimate included treatment and treatment by visit interaction effects.|"Mixed Model Repeated Measures (MMRM) Analysis of Covariance (ANCOVA) model included fixed terms for treatment group, visit, interaction between treatment group and visit, covariate of Baseline QMG score, and random effect for participant.~The differences presented was 'UCB7665 (7 mg/kg) minus Placebo'."||0.8||=0.221
71061165|NCT03052751|141630055|SUPERIORITY||LS Mean Difference vs Placebo|-1.8|||=|0.089|ONE_SIDED|95.0||0.4||One-sided p-value was presented for difference.|MMRM||Estimate included treatment and treatment by visit interaction effects.|"MMRM ANCOVA model included fixed terms for treatment group, visit, interaction between treatment group and visit, covariate of Baseline MG-composite score, and random effect for participant.~The differences presented was 'UCB7665 (7 mg/kg) minus Placebo'."||0.4||=0.089
71061166|NCT03052751|141630056|SUPERIORITY||LS Mean Difference vs Placebo|-1.4|||=|0.036|ONE_SIDED|95.0||-0.1||One-sided p-value was presented for difference.|ANCOVA||Estimate included treatment effect.|ANCOVA model included fixed terms for treatment group, covariate of Baseline MGADL score.||-0.1||=0.036
71061167|NCT05017246|141630057|SUPERIORITY||Mean Difference (Final Values)|-44.9||||0.0249|TWO_SIDED|95.0|-84.0|-5.8|||Two-sample t-test|Unadjusted analysis|Intrathecal - Epidural|||-5.8|-84.0|0.0249
70936712|NCT00824850|141373419|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.37|||||TWO_SIDED|95.0|1.78|3.16|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||3.16|1.78|
70936713|NCT00824850|141373419|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.02|||||TWO_SIDED|95.0|1.63|2.49|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.49|1.63|
70936714|NCT00824850|141373419|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.61|||||TWO_SIDED|95.0|4.31|10.15|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||10.15|4.31|
70936715|NCT00824850|141373419|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.92|||||TWO_SIDED|95.0|3.34|7.26|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||7.26|3.34|
70936716|NCT00824850|141373419|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.73|||||TWO_SIDED|95.0|2.08|3.57|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||3.57|2.08|
70936717|NCT00824850|141373419|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.82|||||TWO_SIDED|95.0|2.08|3.83|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||3.83|2.08|
70936718|NCT00824850|141373419|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.79|||||TWO_SIDED|95.0|2.8|5.13|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||5.13|2.80|
70936719|NCT00824850|141373419|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.32|||||TWO_SIDED|95.0|1.11|1.57|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1.57|1.11|
71061168|NCT05017246|141630058|SUPERIORITY||Risk Ratio (RR)|1.04||||0.94|TWO_SIDED|95.0|0.36|3.01|||Chi-squared||Estimated probability of having the event in Intrathecal group divided by that in Epidural group|||3.01|0.36|0.94
71061169|NCT05017246|141630059|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.59|TWO_SIDED|95.0|-1.01|0.48|||Bootstrap resampling method|Bootstrap resampling method based on raw data was applied for due to highly right-skewed data (5,000 Bootstrap samples were selected).|Intrathecal - Epidural|||0.48|-1.01|0.59
70936720|NCT00824850|141373419|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.05|1.61|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1.61|1.05|
71061170|NCT05017246|141630060|SUPERIORITY||Risk Ratio (RR)|0.95||||0.82|TWO_SIDED|95.0|0.61|1.48|||Chi-squared||Estimated probability of having the event in Intrathecal group divided by that in Epidural group|||1.48|0.61|0.82
70936721|NCT00824850|141373419|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.04|||||TWO_SIDED|95.0|1.51|2.75|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.75|1.51|
70936722|NCT00824850|141373419|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.87|||||TWO_SIDED|95.0|2.19|3.77|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||3.77|2.19|
70941731|NCT04748445|141383935|OTHER||Slope|-0.0004591|STANDARD_ERROR_OF_MEAN|3.83||0.2329|TWO_SIDED|90.0|-0.001094|0.0001755|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0001755|-0.001094|0.2329
71061171|NCT05017246|141630063|SUPERIORITY||Risk Ratio (RR)|1.56||||0.67|TWO_SIDED|95.0|0.27|8.95|||Fisher Exact||Estimated probability of having the event in Intrathecal group divided by that in Epidural group|||8.95|0.27|0.67
71061172|NCT05017246|141630064|SUPERIORITY||Risk Ratio (RR)|2.08||||0.61|TWO_SIDED|95.0|0.19|22.2|||Fisher Exact||Estimated probability of having the event in Intrathecal group divided by that in Epidural group|||22.2|0.19|0.61
71110022|NCT00543985|141725385|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.266|||=|0.14|TWO_SIDED|95.0|||||Regression, Linear|||Pearson Product correlation was used to determine relationships between resting E/E' and Exercise VO2 max and Stress E/E' and Exercise VO2max.||||=0.14
71110023|NCT04570384|141725396|OTHER||Hazard Ratio (HR)|1.14||||0.782|TWO_SIDED|95.0|0.45|2.86|||Log Rank|||||2.86|0.45|0.782
71110024|NCT04570384|141725396|OTHER||Odds Ratio (OR)|1.25||||0.668|TWO_SIDED|95.0|0.46|3.4|||Regression, Logistic|||||3.40|0.46|0.668
71110025|NCT04570384|141725397|OTHER||Hazard Ratio (HR)|1.58||||0.36|TWO_SIDED|95.0|0.59|4.22|||Log Rank|||||4.22|0.59|0.360
71110026|NCT04570384|141725398|OTHER||Hazard Ratio (HR)|0.49||||0.285|TWO_SIDED|95.0|0.13|1.83|||Log Rank|||||1.83|0.13|0.285
70936723|NCT00824850|141373419|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.95|||||TWO_SIDED|95.0|1.59|2.39|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.39|1.59|
70936724|NCT00824850|141373420|SUPERIORITY_OR_OTHER||geometric mean fold rise|201.8|||||TWO_SIDED|95.0|55.11|739.05|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||739.05|55.11|
70936725|NCT00824850|141373420|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.7|||||TWO_SIDED|95.0|5.2|26.1|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||26.10|5.20|
70936726|NCT00824850|141373420|SUPERIORITY_OR_OTHER||geometric mean fold rise|156.4|||||TWO_SIDED|95.0|48.72|501.86|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||501.86|48.72|
70936727|NCT00824850|141373420|SUPERIORITY_OR_OTHER||geometric mean fold rise|37.4|||||TWO_SIDED|95.0|13.71|102.31|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||102.31|13.71|
71110027|NCT04570384|141725398|OTHER||Odds Ratio (OR)|0.6||||0.471|TWO_SIDED|95.0|0.15|2.41|||Regression, Logistic|||||2.41|0.15|0.471
71110028|NCT04570384|141725404|OTHER||Odds Ratio, log|0.81||||0.668|TWO_SIDED|95.0|0.3|2.2|||Zero-inflated negative binomial analyses|||||2.20|0.30|0.668
70852410|NCT00966875|141193446|SUPERIORITY_OR_OTHER|||||||0.236||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.236
70852411|NCT00966875|141193446|SUPERIORITY_OR_OTHER|||||||0.316||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.316
70852412|NCT00966875|141193446|SUPERIORITY_OR_OTHER|||||||0.138||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.138
70852413|NCT00966875|141193446|SUPERIORITY_OR_OTHER|||||||0.975||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.975
70936728|NCT00824850|141373420|SUPERIORITY_OR_OTHER||geometric mean fold rise|93.9|||||TWO_SIDED|95.0|30.99|284.31|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||284.31|30.99|
70936729|NCT00824850|141373420|SUPERIORITY_OR_OTHER||geometric mean fold rise|48.7|||||TWO_SIDED|95.0|23.27|101.97|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||101.97|23.27|
70936730|NCT00824850|141373420|SUPERIORITY_OR_OTHER||geometric mean fold rise|32.1|||||TWO_SIDED|95.0|11.99|85.81|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||85.81|11.99|
70936731|NCT00824850|141373420|SUPERIORITY_OR_OTHER||geometric mean fold rise|78.1|||||TWO_SIDED|95.0|50.42|120.94|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||120.94|50.42|
71110029|NCT04570384|141725404|OTHER||Incidence Rate Ratio|0.66||||0.437|TWO_SIDED|95.0|0.23|1.9|||Zero-inflated negative binomial analyses|||||1.90|0.23|0.437
71110030|NCT04570384|141725405|OTHER||Odds Ratio (OR)|0.35||||0.232|TWO_SIDED|95.0|0.06|1.97|||Regression, Logistic|||||1.97|0.06|0.232
71110031|NCT04570384|141725406|OTHER||Odds Ratio (OR)|0.84||||0.729|TWO_SIDED|95.0|0.31|2.28|||Regression, Logistic|||||2.28|0.31|0.729
71110032|NCT04570384|141725407|OTHER||Odds Ratio, log|1.22||||0.706|TWO_SIDED|95.0|0.43|3.44|||Zero-inflated negative binomial analyses|||||3.44|0.43|0.706
71110033|NCT04570384|141725407|OTHER||Incidence Rate Ratio|1.12||||0.788|TWO_SIDED|95.0|0.49|2.56|||Zero-inflated negative binomial analyses|||||2.56|0.49|0.788
71110034|NCT04570384|141725408|OTHER||Incidence Rate Ratio|1.08||||0.834|TWO_SIDED|95.0|0.52|2.25|||Negative binomial analysis|||||2.25|0.52|0.834
71110035|NCT00237042|141725415|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||Regression, Linear|Linear regression was used to compare group means at follow up, adjusted for baseline values of the outcome variable.||The null hypothesis was that mean characteristic pain intensity at 6-month follow up is equal across the three groups.||||0.19
71110036|NCT00237042|141725416|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Regression, Logistic|Adjusted for baseline value of the outcome variable||||||0.27
71110037|NCT00237042|141725417|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Regression, Linear|Group means compared with linear regression adjusted for baseline values. Adjusted difference: -1.0 between SMT and COCT, -1.0 between TSMT and COCT.||The null hypothesis was that mean characteristic pain intensity at 12-month follow up is equal across the three groups.||||0.003
71110038|NCT00237042|141725418|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||Regression, Logistic|Adjusted for baseline value of the outcome variable||||||0.016
71061173|NCT02719184|141630066|OTHER|The analysis was based on a Mixed Model for Repeated Measures (MMRM) approach with diagnosis group-by-visit and baseline ALD value-by-visit terms, and unstructured covariance matrix structure for repeated measurements within subject.|Adjusted mean difference|-2.89|STANDARD_ERROR_OF_MEAN|1.23||0.0202|TWO_SIDED|95.0|-5.32|-0.45|||Mixed Model for Repeated Measures (MMRM)||The mean difference was calculated as value from COPD GOLD I group - value from Healthy subjects group.|||-0.45|-5.32|0.0202
71117641|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
70852414|NCT00966875|141193446|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED|||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.079
71061174|NCT02719184|141630066|OTHER|The analysis was based on a Mixed Model for Repeated Measures (MMRM) approach with diagnosis group-by-visit and baseline ALD value-by-visit terms, and unstructured covariance matrix structure for repeated measurements within subject.|Adjusted mean difference|-4.78|STANDARD_ERROR_OF_MEAN|1.31||0.0003|TWO_SIDED|95.0|-7.36|-2.19|||Mixed Model for Repeated Measures (MMRM)||The mean difference was calculated as value from COPD GOLD II group - value from Healthy subjects group.|||-2.19|-7.36|0.0003
71061175|NCT02719184|141630066|OTHER|The analysis was based on a Mixed Model for Repeated Measures (MMRM) approach with diagnosis group-by-visit and baseline ALD value-by-visit terms, and unstructured covariance matrix structure for repeated measurements within subject.|Adjusted mean difference|-4.47|STANDARD_ERROR_OF_MEAN|1.51||0.0033|TWO_SIDED|95.0|-7.44|-1.5|||Mixed Model for Repeated Measures (MMRM)||The mean difference was calculated as value from COPD GOLD III group - value from Healthy subjects group.|||-1.50|-7.44|0.0033
71061176|NCT02719184|141630066|OTHER|The analysis was based on a Mixed Model for Repeated Measures (MMRM) approach with diagnosis group-by-visit and baseline ALD value-by-visit terms, and unstructured covariance matrix structure for repeated measurements within subject.|Adjusted mean difference|-5.86|STANDARD_ERROR_OF_MEAN|2.74||0.0334|TWO_SIDED|95.0|-11.26|-0.47|||Mixed Model for Repeated Measures (MMRM)||The mean difference was calculated as value from COPD and A1AT group - value from Healthy subjects group.|||-0.47|-11.26|0.0334
71061177|NCT02719184|141630067|OTHER|A random slope and intercept model with fixed categorical effects of diagnosis group, fixed continuous effects of time, and including diagnosis group-by-time interaction was applied. Random effect was included for subject specific intercept and time. Within-subject errors are modelled by an unstructured variance-covariance matrix.|Unadjusted mean difference|1.3|STANDARD_ERROR_OF_MEAN|14.4||0.9306|TWO_SIDED|95.0|-27.2|29.7|||Random slope and intercept model||The mean difference was calculated as value from COPD GOLD I group - value from Healthy subjects group.|||29.7|-27.2|0.9306
71061178|NCT02719184|141630067|OTHER|A random slope and intercept model with fixed categorical effects of diagnosis group, fixed continuous effects of time, and including diagnosis group-by-time interaction was applied. Random effect was included for subject specific intercept and time. Within-subject errors are modelled by an unstructured variance-covariance matrix.|Unadjusted mean difference|-19.2|STANDARD_ERROR_OF_MEAN|14.9||0.1983|TWO_SIDED|95.0|-48.5|10.1|||Random slope and intercept model|The mean difference was calculated as value from COPD GOLD II group - value from Healthy subjects group.||||10.1|-48.5|0.1983
71061179|NCT02719184|141630067|OTHER|A random slope and intercept model with fixed categorical effects of diagnosis group, fixed continuous effects of time, and including diagnosis group-by-time interaction was applied. Random effect was included for subject specific intercept and time. Within-subject errors are modelled by an unstructured variance-covariance matrix.|Unadjusted mean difference|-33.6|STANDARD_ERROR_OF_MEAN|16.1||0.0381|TWO_SIDED|95.0|-65.4|-1.9|||Random slope and intercept model||The mean difference was calculated as value from COPD GOLD III group - value from Healthy subjects group.|||-1.9|-65.4|0.0381
71061180|NCT02719184|141630067|OTHER|A random slope and intercept model with fixed categorical effects of diagnosis group, fixed continuous effects of time, and including diagnosis group-by-time interaction was applied. Random effect was included for subject specific intercept and time. Within-subject errors are modelled by an unstructured variance-covariance matrix.|Unadjusted mean difference|-61.8|STANDARD_ERROR_OF_MEAN|30.3||0.0419|TWO_SIDED|95.0|-121.3|-2.3|||Random slope and intercept model||The mean difference was calculated as value from COPD and A1AT group - value from Healthy subjects group.|||-2.3|-121.3|0.0419
71061181|NCT01690117|141630110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.47|STANDARD_ERROR_OF_MEAN|1.83|<|0.001|TWO_SIDED|95.0|3.82|11.12||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||11.12|3.82|<0.001
71061182|NCT01690117|141630111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.43|STANDARD_ERROR_OF_MEAN|2.21|<|0.05|TWO_SIDED|95.0|1.0|9.86||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||9.86|1.00|<0.05
71061183|NCT01690117|141630112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.99|STANDARD_ERROR_OF_MEAN|1.0|<|0.01|TWO_SIDED|95.0|1.01|4.97||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||4.97|1.01|<0.01
71061184|NCT01690117|141630113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|0.87||0.06|TWO_SIDED|95.0|-0.05|3.45||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||3.45|-0.05|0.06
71061185|NCT01690117|141630114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|1.22||0.3|TWO_SIDED|95.0|-0.65|2.07||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||2.07|-0.65|0.30
70936732|NCT00824850|141373420|SUPERIORITY_OR_OTHER||geometric mean fold rise|10.3|||||TWO_SIDED|95.0|6.8|15.72|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||15.72|6.80|
70936733|NCT00824850|141373420|SUPERIORITY_OR_OTHER||geometric mean fold rise|61.7|||||TWO_SIDED|95.0|32.75|116.34|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||116.34|32.75|
70936734|NCT00824850|141373420|SUPERIORITY_OR_OTHER||geometric mean fold rise|536.5|||||TWO_SIDED|95.0|212.04|1357.19|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1357.19|212.04|
70936735|NCT00824850|141373420|SUPERIORITY_OR_OTHER||geometric mean fold rise|116.9|||||TWO_SIDED|95.0|33.28|410.33|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||410.33|33.28|
70936736|NCT00824850|141373420|SUPERIORITY_OR_OTHER||geometric mean fold rise|24.6|||||TWO_SIDED|95.0|11.3|53.42|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||53.42|11.30|
70936737|NCT00824850|141373421|SUPERIORITY_OR_OTHER||geometric mean fold rise|168.8|||||TWO_SIDED|95.0|20.22|1409.76|||||CI for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1409.76|20.22|
70936738|NCT00824850|141373421|SUPERIORITY_OR_OTHER||geometric mean fold rise|40.3|||||TWO_SIDED|95.0|10.97|148.44|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMRFs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||148.44|10.97|
71061186|NCT01690117|141630115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|1.02||0.24|TWO_SIDED|95.0|-0.66|2.59||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||2.59|-0.66|0.24
71061187|NCT01690117|141630116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|1.04|<|0.05|TWO_SIDED|95.0|-2.5|1.62||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||1.62|-2.50|<0.05
71061188|NCT01690117|141630117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|8.86||0.88|TWO_SIDED|95.0|-2.63|2.25||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||2.25|-2.63|0.88
70852415|NCT00966875|141193448|SUPERIORITY_OR_OTHER|||||||0.982||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.982
70936739|NCT00824850|141373421|SUPERIORITY_OR_OTHER||geometric mean fold rise|61.9|||||TWO_SIDED|95.0|18.83|203.72|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||203.72|18.83|
70936740|NCT00824850|141373421|SUPERIORITY_OR_OTHER||geometric mean fold rise|26.7|||||TWO_SIDED|95.0|9.67|73.84|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||73.84|9.67|
70936741|NCT00824850|141373421|SUPERIORITY_OR_OTHER||geometric mean fold rise|226.9|||||TWO_SIDED|95.0|79.81|645.29|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||645.29|79.81|
70936742|NCT00824850|141373421|SUPERIORITY_OR_OTHER||geometric mean fold rise|116.8|||||TWO_SIDED|95.0|54.54|250.13|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||250.13|54.54|
70936743|NCT00824850|141373421|SUPERIORITY_OR_OTHER||geometric mean fold rise|481.0|||||TWO_SIDED|95.0|207.01|1117.69|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1117.69|207.01|
71061189|NCT01690117|141630118|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.93|STANDARD_ERROR_OF_MEAN|1.92|<|0.05|TWO_SIDED|95.0|-8.74|-1.11||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||-1.11|-8.74|<0.05
71110039|NCT01897532|141725441|NON_INFERIORITY|The non-inferiority margin was chosen as 1.3 (FDA Guidance for Industry - Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes).|Hazard Ratio (HR)|1.02||||0.0002|TWO_SIDED|95.0|0.89|1.17||p-value for Hazard ratio (HR) ≥1.3 (1-sided)|Regression, Cox|Based on a Cox regression model with terms for treatment group and region.||Cox proportional hazard regression model was performed to compare the effect of linagliptin versus placebo. Model included randomised treatment and geographical region as factors. Breslow's method was used for dealing with ties. First hypothesis (non-inferiority of the primary endpoint) was to be tested at the one-sided alpha-level of 2.5%. In case of significance the next set of hypotheses (two separate hypothesis tests) were to be tested with a sequentially rejective multiple test procedure.||1.17|0.89|0.0002
71110040|NCT01897532|141725441|OTHER||Hazard Ratio (HR)|1.02||||0.6301|TWO_SIDED|95.0|0.89|1.17||p-value for HR ≥1.0 (1-sided).|Regression, Cox|Based on a Cox regression model with terms for treatment group and region.||Cox proportional hazard regression model was performed to compare the effect of linagliptin versus placebo. Model included randomised treatment and geographical region as factors. Breslow's method was used for dealing with ties. First hypothesis (non-inferiority of the primary endpoint) was to be tested at the one-sided alpha-level of 2.5%. In case of significance the next set of hypotheses (two separate hypothesis tests) were to be tested with a sequentially rejective multiple test procedure.||1.17|0.89|0.6301
71110041|NCT01897532|141725442|OTHER||Hazard Ratio (HR)|1.04||||0.6918|TWO_SIDED|95.0|0.89|1.22||p-value for HR ≥1.0 (1-sided)|Regression, Cox|Based on a Cox regression model with terms for treatment group and region.||Cox proportional hazard regression model was performed to compare the effect of linagliptin versus placebo. Model included randomised treatment and geographical region as factors. Breslow's method was used for dealing with ties. First hypothesis (non-inferiority of the primary endpoint) was to be tested at the one-sided alpha-level of 2.5%. In case of significance the next set of hypotheses (two separate hypothesis tests) were to be tested with a sequentially rejective multiple test procedure.||1.22|0.89|0.6918
71110042|NCT00038948|141725445|SUPERIORITY_OR_OTHER||Weighted difference|-2.68||||0.575||95.0|-12.27|6.91||Analysis of covariance p-value|ANCOVA||Data was adjusted for baseline and center.|Baseline GFR of 20.0 to 40.0 mL/min||6.91|-12.27|0.575
71110043|NCT00038948|141725445|SUPERIORITY_OR_OTHER||Weighted difference|1.31||||0.278||95.0|-1.06|3.69||Analysis of covariance p-value|ANCOVA||Data was adjusted for baseline and center.|Baseline GFR of \>40.0 mL/min||3.69|-1.06|0.278
71110044|NCT00038948|141725446|SUPERIORITY_OR_OTHER|||||||0.135||||||Tests the equality of rates between treatments across strata at 52 weeks.|Cochran-Mantel-Haenszel|||52 weeks statistical analysis across strata||||0.135
71110045|NCT00038948|141725446|SUPERIORITY_OR_OTHER|||||||0.559||||||Tests the equality of rates between treatments across strata at 104 weeks.|Cochran-Mantel-Haenszel|||104 weeks statistical analysis across strata||||0.559
71110046|NCT03682965|141725447|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
71110047|NCT03682965|141725448|SUPERIORITY||||||<|0.05||||||The Holm-Bonferroni correction for multiple tests was used because the two outcomes are based on correlated data.|Clopper-Pearson binomial exact test|||The secondary efficacy endpoint was the percentage of days during peak pollen season for which the average total combined score was lower in the immunotherapy group than in the placebo group.||||<0.05
71110048|NCT03682965|141725450|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||||||0.23
71110049|NCT04552041|141725511|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 24 weeks row.||||<0.0001
71110050|NCT04552041|141725512|SUPERIORITY|||||||0.0028|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 24 weeks row.||||0.0028
71110051|NCT04552041|141725512|SUPERIORITY|||||||0.1739|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Delusional ideas ∆ between baseline and 24 weeks row."||||0.1739
71110052|NCT04552041|141725512|SUPERIORITY|||||||0.0559|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Hallucinations ∆ between baseline and 24 weeks row."||||0.0559
71110053|NCT04552041|141725512|SUPERIORITY|||||||0.0174|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Agitation ∆ between baseline and 24 weeks row."||||0.0174
71110054|NCT04552041|141725512|SUPERIORITY|||||||0.333|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Aggression ∆ between baseline and 24 weeks row."||||0.3330
71110055|NCT04552041|141725512|SUPERIORITY|||||||0.1037|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Dysphoria ∆ between baseline and 24 weeks row."||||0.1037
71110056|NCT04552041|141725512|SUPERIORITY|||||||0.0329|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Anxiety ∆ between baseline and 24 weeks row."||||0.0329
71110057|NCT04552041|141725512|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Euphoria ∆ between baseline and 24 weeks row."||||0.2700
71110058|NCT04552041|141725512|SUPERIORITY|||||||0.0557|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Apathy ∆ between baseline and 24 weeks row."||||0.0557
71110059|NCT04552041|141725512|SUPERIORITY|||||||0.982|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Disinhibition ∆ between baseline and 24 weeks row."||||0.9820
71110060|NCT04552041|141725512|SUPERIORITY|||||||0.4626|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Irritability ∆ between baseline and 24 weeks row."||||0.4626
71061190|NCT01690117|141630119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.49|STANDARD_ERROR_OF_MEAN|2.41|<|0.001|TWO_SIDED|95.0|-13.31|-3.66||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||-3.66|-13.31|<0.001
71061191|NCT01690117|141630120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.91|STANDARD_ERROR_OF_MEAN|1.98||0.05|TWO_SIDED|95.0|-7.86|0.04||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||0.04|-7.86|0.05
71061192|NCT01690117|141630121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|2.1||0.91|TWO_SIDED|95.0|-3.96|4.45||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||4.45|-3.96|0.91
71061193|NCT01690117|141630122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|1.47||0.05|TWO_SIDED|95.0|-0.01|5.81||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||5.81|-0.01|0.05
71061194|NCT01690117|141630123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5|STANDARD_ERROR_OF_MEAN|1.91|<|0.05|TWO_SIDED|95.0|0.68|8.33||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||8.33|0.68|<0.05
71061195|NCT01690117|141630124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.53|STANDARD_ERROR_OF_MEAN|1.95|<|0.01|TWO_SIDED|95.0|-8.4|-0.65||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||-0.65|-8.40|<0.01
71061196|NCT01690117|141630125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.8|STANDARD_ERROR_OF_MEAN|1.52|<|0.01|TWO_SIDED|95.0|4.78|10.83||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||10.83|4.78|<0.01
71061197|NCT02792517|141630132|OTHER||Least Squares Geometric Mean Ratio|1.04|||||TWO_SIDED|90.0|0.88|1.22|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed Cmax was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.||1.22|0.88|
71061198|NCT02792517|141630133|OTHER||Least Squares Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.91|1.14|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed AUCtau was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.||1.14|0.91|
71061199|NCT02792517|141630134|OTHER||Least Squares Geometric Mean Ratio|1.06|||||TWO_SIDED|90.0|0.97|1.16|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed Cmax was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.||1.16|0.97|
71061200|NCT02792517|141630135|OTHER||Least Squares Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|0.96|1.1|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed AUCtau was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.||1.10|0.96|
71061201|NCT02792517|141630136|OTHER||Least Squares Geometric Mean Ratio|1.05|||||TWO_SIDED|90.0|0.9|1.23|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed Cmax was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.||1.23|0.90|
71110061|NCT04552041|141725512|SUPERIORITY|||||||0.0006|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Aberrant motor behaviour ∆ between baseline and 24 weeks row."||||0.0006
71061202|NCT02792517|141630137|OTHER||Least Squares Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.94|1.12|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed AUCtau was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.||1.12|0.94|
71061203|NCT00663793|141630143|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 8 per group was estimated to confer an 80% power to detect a 40% difference in testosterone AUC with a standard deviation of 20% at an alpha of 0.05|||||<|0.05|TWO_SIDED|95.0|||||Wilcoxon sign-rank|||||||<0.05
71061204|NCT00663793|141630144|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation was performed for this pilot study.|||||<|0.05||95.0|||||Wilcoxon sign-rank|||||||<0.05
71061205|NCT00663793|141630145|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation was performed for this pilot study||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Area-under-the-curve for serum estradiol||||0.05
71061206|NCT03743051|141630150|SUPERIORITY|The Multiple Imputation process (N=100) was performed leading to least squares mean (LSM) and standard error (SE) estimates using the ANOVA model (including treatment group and the 3 stratification factors at randomization as categorical covariates). The estimates were pooled using Rubin rule, with corresponding p-value for difference between treatment groups. The 95% confidence interval (CI) was calculated for each treatment group and for the pooled difference between the groups.|Mean Difference (Final Values)|1.345|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|0.718|1.971|||ANOVA|||"To declare anamorelin superior to placebo, both co-primary endpoints had to be significant.~The null hypothesis for mean change in body weight from baseline over 12 weeks (H0w) and the corresponding alternative hypothesis (H1w) were:~H0w: MWa = MW; H1w: MWa ≠ MWp~Where MWa is the mean change in body weight from baseline over 12 weeks for the anamorelin arm and MWp is the mean change in body weight from baseline over 12 weeks for the placebo arm."||1.971|0.718|<0.0001
71110062|NCT04552041|141725512|SUPERIORITY|||||||0.3725|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Sleep disorders ∆ between baseline and 24 weeks row."||||0.3725
71110063|NCT04552041|141725512|SUPERIORITY|||||||0.1013|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Appetite disorders ∆ between baseline and 24 weeks row."||||0.1013
71110064|NCT04552041|141725512|SUPERIORITY|||||||0.0432|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Aberrant vocalizations ∆ between baseline and 24 weeks row."||||0.0432
71110065|NCT04552041|141725513|SUPERIORITY|||||||0.0316|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 12 weeks row.||||0.0316
71110066|NCT04552041|141725514|SUPERIORITY|||||||0.1483|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 12 weeks row.||||0.1483
70936744|NCT00824850|141373421|SUPERIORITY_OR_OTHER||geometric mean fold rise|66.5|||||TWO_SIDED|95.0|41.8|105.75|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||105.75|41.80|
70936745|NCT00824850|141373421|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.6|||||TWO_SIDED|95.0|5.36|13.94|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||13.94|5.36|
70936746|NCT00824850|141373421|SUPERIORITY_OR_OTHER||geometric mean fold rise|78.2|||||TWO_SIDED|95.0|41.38|147.8|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||147.80|41.38|
71061207|NCT03743051|141630151|SUPERIORITY|The Multiple Imputation process (N=100) was performed leading to least squares mean (LSM) and standard error (SE) estimates using the ANOVA model (including treatment group and the 3 stratification factors at randomization as categorical covariates). The estimates were pooled using Rubin rule, with corresponding p-value for difference between treatment groups. The 95% confidence interval (CI) was calculated for each treatment group and for the pooled difference between the groups.|Mean Difference (Final Values)|0.622|STANDARD_ERROR_OF_MEAN|0.434||0.1514|TWO_SIDED|95.0|-0.228|1.472|||ANOVA|||"To declare anamorelin superior to the placebo, both co-primary endpoints had to be significant.~The null hypothesis for mean change from baseline over 12 weeks in patient 5-IASS (H0A) and the corresponding alternative (H1A) were:~H0A: MAa = MAp; H1A: MAa ≠ MAp~Where MAa is the mean change from baseline over 12 weeks in 5-IASS for the anamorelin arm and MAp is the mean change from baseline over 12 weeks in 5-IASS for the placebo arm."||1.472|-0.228|0.1514
70852416|NCT00966875|141193448|SUPERIORITY_OR_OTHER|||||||0.276||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.276
71061208|NCT03743051|141630152|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|2.41|STANDARD_ERROR_OF_MEAN|0.532|<|0.0001|TWO_SIDED|95.0|1.367|3.453|||ANOVA|||||3.453|1.367|<0.0001
71061209|NCT03743051|141630153|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|1.336|STANDARD_ERROR_OF_MEAN|0.484||0.0057|TWO_SIDED|95.0|0.388|2.284|||ANOVA|||||2.284|0.388|0.0057
71061210|NCT03743051|141630154|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|1.027|STANDARD_ERROR_OF_MEAN|0.403||0.0108|TWO_SIDED|95.0|0.238|1.816|||ANOVA|||||1.816|0.238|0.0108
71061211|NCT03743051|141630155|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|0.535|STANDARD_ERROR_OF_MEAN|0.475||0.2605|TWO_SIDED|95.0|-0.397|1.466|||ANOVA|||||1.466|-0.397|0.2605
71061212|NCT00811733|141630156|SUPERIORITY_OR_OTHER||percentage of participants|47.0|||||TWO_SIDED|95.0|21.3|73.4|||||The estimated value represents the percentage of participants with OR.|||73.4|21.3|
71061213|NCT00811733|141630156|SUPERIORITY_OR_OTHER||percentage of participants|68.0|||||TWO_SIDED|95.0|45.1|86.1|||||The estimated value represents the percentage of participants with OR.|||86.1|45.1|
71061214|NCT00811733|141630157|SUPERIORITY_OR_OTHER||percentage of participants|33.0|||||TWO_SIDED|95.0|11.8|61.6|||||The estimated value represents the percentage of participants with OR.|||61.6|11.8|
70936747|NCT00824850|141373421|SUPERIORITY_OR_OTHER||geometric mean fold rise|438.1|||||TWO_SIDED|95.0|169.52|1132.43|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1132.43|169.52|
70936748|NCT00824850|141373421|SUPERIORITY_OR_OTHER||geometric mean fold rise|80.0|||||TWO_SIDED|95.0|23.28|274.82|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||274.82|23.28|
71061215|NCT00811733|141630157|SUPERIORITY_OR_OTHER||percentage of participants|64.0|||||TWO_SIDED|95.0|40.7|82.8|||||The estimated value represents the percentage of participants with OR.|||82.8|40.7|
71061216|NCT02200055|141630218|SUPERIORITY_OR_OTHER|This measurement was collected for each participant. A pre-operative and post-operative bioimpedance measurement was taken.|Mean Difference (Final Values)|0.53|||<|0.01|TWO_SIDED||||||Chi-squared|||||||<0.01
71061217|NCT03442751|141630224|SUPERIORITY||Mean Difference (Net)|-1.0||||0.0004|TWO_SIDED|95.0|-1.5|-0.4|||ANCOVA|||Repeated measures mixed analysis of covariance model||-0.4|-1.5|0.0004
71061218|NCT03442751|141630225|SUPERIORITY|last observation carried forward was used to impute missing Month 12 data|Mean Difference (Net)|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.6|||ANCOVA|||repeated measures mixed analysis of covariance model||-0.6|-1.6|<0.0001
71061219|NCT01015534|141630267|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.9||||0.019|TWO_SIDED|95.0|1.3|12.9||The sample size was calculated with a two-sided test,a type-I error probability of 0.05 and a power of 0.80,Twenty- eight patients in each treatment arm were required to detect a difference in ORR of 0.29|Chi-squared|||||12.9|1.3|0.019
71061220|NCT01015534|141630268|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.688||||0.704|TWO_SIDED|95.0|0.138|3.422|||Fisher Exact|||||3.422|.138|.704
71061221|NCT01015534|141630269|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Log Rank|||||||0.84
71061222|NCT02845700|141630342|SUPERIORITY|||||||0.08|||||||ANOVA|2 (time) x 2 (group) x 5 (dilution %) repeated measures ANOVA||||||.08
70936749|NCT00824850|141373421|SUPERIORITY_OR_OTHER||geometric mean fold rise|61.5|||||TWO_SIDED|95.0|28.73|131.76|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||131.76|28.73|
71061223|NCT02845700|141630343|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|t(4) = -1.19, p = .39||Post-hoc estimates of observed power for the difference between group means was calculated to be .15.||||.39
71061224|NCT02845700|141630346|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|t(4) = 0.66, p = .54||Post-hoc estimates of observed power for the difference between group means was calculated to be .08.||||.54
71061225|NCT02452476|141630347|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.93|TWO_SIDED|95.0|-0.4|0.44|||Mixed model for repeated measurements|||"Day 1, 30 min post dose.~SpO2/FiO2 and FiO2 (%) over the first 24 hours: analyzed using a linear mixed model for repeated measures (MMRM) including treatment, timepoint, treatment by timepoint interaction, investigational site and gestational age (GA) group as fixed effects, and predose values as covariates. The adjusted mean difference between treatments, and their 95% confidence intervals (CIs) at each timepoint and averaged over the first 24 hours were estimated by the model."||0.44|-0.40|0.930
71061226|NCT02452476|141630347|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.346|TWO_SIDED|95.0|-0.59|0.21|||Mixed model for repeated measurements|||Day 1, 1 h post dose||0.21|-0.59|0.346
71061227|NCT02452476|141630347|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.549|TWO_SIDED|95.0|-0.43|0.23|||Mixed model for repeated measurements|||Day 1, 3 h post dose||0.23|-0.43|0.549
71061228|NCT02452476|141630347|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.539|TWO_SIDED|95.0|-0.43|0.23|||Mixed model for repeated measurements|||Day 1, 6 h post dose||0.23|-0.43|0.539
71061229|NCT02452476|141630347|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.491|TWO_SIDED|95.0|-0.21|0.43|||Mixed model for repeated measurements|||Day 1, 12 h post dose||0.43|-0.21|0.491
71061230|NCT02452476|141630347|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.623|TWO_SIDED|95.0|-0.22|0.37|||Mixed model for repeated measurements|||Day 1, 18 h post dose||0.37|-0.22|0.623
71061231|NCT02452476|141630347|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.608|TWO_SIDED|95.0|-0.25|0.43|||Mixed model for repeated measurements|||Day 1, 24 h post dose||0.43|-0.25|0.608
71061232|NCT02452476|141630347|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.869|TWO_SIDED|95.0|-0.35|0.3|||Mixed Models Analysis|||"Day 2, post dose~SpO2/FiO2 was compared between treatments at the remaining post-treatment time points (i.e., Days 2, 3, 5, 7): analyzed using mixed model including treatment, investigational site and gestational age group as fixed effects and pre-dose ratio as covariate."||0.30|-0.35|0.869
71061233|NCT02452476|141630347|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.833|TWO_SIDED|95.0|-0.38|0.31|||Mixed Models Analysis|||Day 3, post dose||0.31|-0.38|0.833
71061234|NCT02452476|141630347|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.772|TWO_SIDED|95.0|-0.39|0.29|||Mixed Models Analysis|||Day 5, post dose||0.29|-0.39|0.772
71061235|NCT02452476|141630347|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.963|TWO_SIDED|95.0|-0.33|0.35|||Mixed Models Analysis|||Day 7, post dose||0.35|-0.33|0.963
71061236|NCT02452476|141630348|SUPERIORITY||Mean Difference (Final Values)|-1.94||||0.519|TWO_SIDED|95.0|-7.87|3.99|||Mixed model for repeated measurements|||Day 1, 30 min post dose||3.99|-7.87|0.519
71061237|NCT02452476|141630348|SUPERIORITY||Mean Difference (Final Values)|2.45||||0.282|TWO_SIDED|95.0|-2.04|6.93|||Mixed model for repeated measurements|||Day 1, 1 h post dose||6.93|-2.04|0.282
71061238|NCT02452476|141630348|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.854|TWO_SIDED|95.0|-4.04|4.86|||Mixed model for repeated measurements|||Day 1, 3 h post dose||4.86|-4.04|0.854
71061239|NCT02452476|141630348|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.861|TWO_SIDED|95.0|-5.0|4.19|||Mixed model for repeated measurements|||Day 1, 6 h post dose||4.19|-5.00|0.861
71061240|NCT02452476|141630348|SUPERIORITY||Mean Difference (Final Values)|-2.77||||0.117|TWO_SIDED|95.0|-6.24|0.7|||Mixed model for repeated measurements|||Day 1, 12 h post dose||0.70|-6.24|0.117
71061241|NCT02452476|141630348|SUPERIORITY||Mean Difference (Final Values)|-1.92||||0.185|TWO_SIDED|95.0|-4.79|0.94|||Mixed model for repeated measurements|||Day 1, 18 h post dose||0.94|-4.79|0.185
71061242|NCT02452476|141630348|SUPERIORITY||Mean Difference (Final Values)|-1.01||||0.678|TWO_SIDED|95.0|-5.82|3.8|||Mixed model for repeated measurements|||Day 1, 24 h post dose||3.80|-5.82|0.678
71061243|NCT02452476|141630348|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.961|TWO_SIDED|95.0|-3.49|3.67|||Mixed Models Analysis|||"Day 2, post dose~SpO2/FiO2 was compared between treatments at the remaining post-treatment time points (i.e., Days 2, 3, 5, 7): analyzed using mixed model including treatment, investigational site and gestational age group as fixed effects and pre-dose ratio as covariate."||3.67|-3.49|0.961
71061244|NCT02452476|141630348|SUPERIORITY||Mean Difference (Final Values)|-1.53||||0.544|TWO_SIDED|95.0|-6.53|3.46|||Mixed Models Analysis|||Day 3, post dose||3.46|-6.53|0.544
71061245|NCT02452476|141630348|SUPERIORITY||Mean Difference (Final Values)|1.74||||0.492|TWO_SIDED|95.0|-3.28|6.76|||Mixed Models Analysis|||Day 5, post dose||6.76|-3.28|0.492
71061246|NCT02452476|141630348|SUPERIORITY||Mean Difference (Final Values)|1.23||||0.634|TWO_SIDED|95.0|-3.9|6.36|||Mixed Models Analysis|||Day 7, post dose||6.36|-3.90|0.634
71061247|NCT02452476|141630349|SUPERIORITY|Mortality or BPD incidence at 36-week PMA was compared by treatment, using Cochran-Mantel-Haenszel (CMH), adjusting for stratification gestational age (GA) group. Relative risk (RR) and its 95% confidence interval are also provided.|Relative risk|1.03||||0.811|TWO_SIDED|95.0|0.81|1.32|||Cochran-Mantel-Haenszel|||Week 36 PMA Incidence of BPD||1.32|0.81|0.811
71110067|NCT04552041|141725515|SUPERIORITY|||||||0.0018|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to Therapeutic effect row.||||0.0018
71061248|NCT02452476|141630349|SUPERIORITY||Relative risk|1.0||||0.972|TWO_SIDED|95.0|0.81|1.25|||Cochran-Mantel-Haenszel|||Week 36 PMA Incidence of Mortality/BPD||1.25|0.81|0.972
71061249|NCT02452476|141630349|SUPERIORITY||Relative risk|0.74||||0.619|TWO_SIDED|95.0|0.23|2.42|||Cochran-Mantel-Haenszel|||Week 36 PMA Mortality||2.42|0.23|0.619
71061250|NCT02452476|141630349|SUPERIORITY||Relative risk|1.46||||0.602|TWO_SIDED|95.0|0.35|6.09|||Cochran-Mantel-Haenszel|||Day 28 PNA Mortality||6.09|0.35|0.602
71061251|NCT02452476|141630349|SUPERIORITY||Relative risk|0.56||||0.606|TWO_SIDED|95.0|0.06|5.29|||Cochran-Mantel-Haenszel|||Day 14 PNA RDS-associated mortality in 14 days of life||5.29|0.06|0.606
71061252|NCT02452476|141630350|SUPERIORITY||Odds Ratio (OR)|0.69||||0.409|TWO_SIDED|95.0|0.3|1.57|||Fisher Exact|||||1.57|0.30|0.409
71061253|NCT02452476|141630351|SUPERIORITY|The percentage of patients requiring at least one rescue surfactant dose were compared by treatment group using the Fisher's exact test at 5% significance interval. Odds ratio (OR) and related exact 95% CI are also provided.|Odds Ratio (OR)|1.21||||0.689|TWO_SIDED|95.0|0.55|2.67|||Fisher Exact|||The percentage of patients requiring at least one rescue surfactant dose.||2.67|0.55|0.689
71061254|NCT02452476|141630352|SUPERIORITY|||||||0.935|||||||Wilcoxon (Mann-Whitney)|||||||0.935
71110068|NCT04552041|141725515|SUPERIORITY|||||||0.4733|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to Side effects row.||||0.4733
71110069|NCT04552041|141725515|SUPERIORITY|||||||0.0035|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to Efficiency index row.||||0.0035
71110070|NCT00661830|141725516|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.281|||||TWO_SIDED|95.0|0.811|2.023|||Regression, Cox|||||2.023|0.811|
71061255|NCT02654054|141630391|SUPERIORITY||Odds Ratio (OR)|56.79|||<|0.001|TWO_SIDED|95.0|23.002|140.227||The P value for test of difference is by pooling the results from a logistic regression model including treatment as the main effect and baseline MBL volume as a covariate in each data set from multiple imputation.|Regression, Logistic|||||140.227|23.002|< 0.001
71061256|NCT02654054|141630391|SUPERIORITY||Odds Ratio (OR)|22.98|||<|0.001|TWO_SIDED|95.0|10.466|50.451||The P value for test of difference is by pooling the results from a logistic regression model including treatment as the main effect and baseline MBL volume as a covariate in each data set from multiple imputation.|Regression, Logistic|||||50.451|10.466|< 0.001
71061257|NCT02654054|141630392|SUPERIORITY||LS Mean of Difference|-222.3|STANDARD_ERROR_OF_MEAN|20.77|<|0.001|TWO_SIDED|||||The P value for test of difference between each elagolix treatment group and placebo is by pooling the results from an ANCOVA model with treatment as the main effect and baseline MBL volume as a covariate in each dataset from multiple imputation.|ANCOVA|||||||< 0.001
71061258|NCT02654054|141630392|SUPERIORITY||LS Mean of Difference|-177.5|STANDARD_ERROR_OF_MEAN|18.24|<|0.001|TWO_SIDED|||||The P value for test of difference between each elagolix treatment group and placebo is by pooling the results from an ANCOVA model with treatment as the main effect and baseline MBL volume as a covariate in each dataset from multiple imputation.|ANCOVA|||||||< 0.001
71061259|NCT02654054|141630393|SUPERIORITY||Between-Group Difference (%)|79.6|||<|0.001|TWO_SIDED|95.0|71.13|88.16||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|Chi-square or Fisher's exact test|||||88.16|71.13|< 0.001
71061260|NCT02654054|141630393|SUPERIORITY||Between-Group Difference (%)|52.4|||<|0.001|TWO_SIDED|95.0|44.11|60.76||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|Chi-square or Fisher's exact test|||||60.76|44.11|< 0.001
71061261|NCT02654054|141630394|SUPERIORITY||LS Mean of Difference|-234.0|STANDARD_ERROR_OF_MEAN|19.27|<|0.001|TWO_SIDED|||||The P value is from mixed models repeated measures (MMRM) with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
71110071|NCT00661830|141725517|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.747|1.927|||Regression, Cox|||||1.927|0.747|
71110072|NCT01669902|141725568|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon signed rank test|||Change at Month 3||||<0.0001
71110073|NCT01669902|141725568|SUPERIORITY_OR_OTHER|||||||0.0357|TWO_SIDED||||||Wilcoxon signed rank test|||Change at Month 6||||0.0357
71110074|NCT01047189|141725572|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Kruskal-Wallis|||||||0.05
71110075|NCT00052910|141725579|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.99|||||TWO_SIDED|95.0|0.79|1.24|||||Adjusted Hazard Ratio, ECF vs 5-FU/LV|||1.24|0.79|
71110076|NCT00052910|141725580|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.03|||||TWO_SIDED|95.0|0.83|1.28|||||Adjusted Hazard Ratio, ECF vs 5-FU/LV|||1.28|0.83|
71110077|NCT01187095|141725581|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Estimation parameter|||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71110078|NCT01187095|141725581|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|||||||<0.05
71110079|NCT01475721|141725590|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority comparison is statistically significant if the upper bound of the two-sided 95% CI falls below 2, the non-inferiority margin, and the non-inferiority test one-sided p-value \<0.025.|Hazard Ratio (HR)|1.029||||0.003|TWO_SIDED|95.0|0.638|1.662|||Regression, Cox|||||1.662|0.638|0.003
71110080|NCT01475721|141725591|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.834||||0.203|TWO_SIDED|95.0|0.63|1.103|||Regression, Cox||Analysis of time to first exacerbation in efficacy subgroup: Subjects not well-controlled on prior ICS or non-LABA therapy.|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||1.103|0.630|0.203
71110081|NCT01475721|141725591|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.839||||0.188|TWO_SIDED|95.0|0.645|1.09|||Regression, Cox||Analysis of time to first exacerbation in efficacy subgroup: Subjects not well-controlled on prior ICS+LABA therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||1.090|0.645|0.188
70936750|NCT00824850|141373422|SUPERIORITY_OR_OTHER||geometric mean fold rise|281.7|||||TWO_SIDED|95.0|76.65|1035.49|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1035.49|76.65|
71061262|NCT02654054|141630394|SUPERIORITY||LS Mean of Difference|-192.5|STANDARD_ERROR_OF_MEAN|16.7|<|0.001|TWO_SIDED|||||The P value is from mixed models repeated measures (MMRM) with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
71061263|NCT02654054|141630395|SUPERIORITY||LS Mean of Difference|-240.8|STANDARD_ERROR_OF_MEAN|21.69|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
71061264|NCT02654054|141630395|SUPERIORITY||LS Mean of Difference|-198.2|STANDARD_ERROR_OF_MEAN|18.76|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
71061265|NCT02654054|141630396|SUPERIORITY||Between-Group Difference (%)|49.7|||<|0.001|TWO_SIDED|95.0|30.27|69.18||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|chi-square or Fisher's exact test|||||69.18|30.27|< 0.001
71061266|NCT02654054|141630396|SUPERIORITY||Between-Group Difference (%)|45.4|||<|0.001|TWO_SIDED|95.0|26.9|63.92||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|chi-square or Fisher's exact test|||||63.92|26.90|< 0.001
71061267|NCT02654054|141630397|SUPERIORITY||LS Mean of Difference|-190.0|STANDARD_ERROR_OF_MEAN|22.59|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
71061268|NCT02654054|141630397|SUPERIORITY||LS Mean of Difference|-116.2|STANDARD_ERROR_OF_MEAN|19.7|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
71061269|NCT00420420|141630398|SUPERIORITY_OR_OTHER|||||||0.283||95.0||||A longitudinal mixed model was used to compare groups, including factors for week, strata (MMSE score and concomitant AD therapy), treatment, and week-by-treatment interaction.|Mixed Models Analysis|||comparison at Week 4||||0.283
71061270|NCT00420420|141630399|SUPERIORITY_OR_OTHER|||||||0.18||95.0||||A longitudinal mixed model was used to compare groups, including factors for week, strata (MMSE score and concomitant AD therapy), treatment, and week-by-treatment interaction.|Mixed Models Analysis|||comparison at week 4||||0.180
71061271|NCT00420420|141630400|SUPERIORITY_OR_OTHER|||||||0.716||95.0||||A longitudinal mixed model was used to compare groups, including factors for week, strata (MMSE score and concomitant AD therapy), treatment, and week-by-treatment interaction.|Mixed Models Analysis|||comparison at Week 4||||0.716
71061272|NCT00273182|141630404|SUPERIORITY_OR_OTHER||Overall survival rate at 36 month|71.0|||||TWO_SIDED|95.0|68.6|73.2||No p values for the analysis.|Kaplan-Meier (product limit) estimates|Survival curves of cause-specific mortality were created based on Kaplan-Meier (product limit) estimates.|The estimate is the overall survival rate at 36 month. left-truncation methods were used in the survival analysis for previously implanted subjects.|For overall mortality, the endpoint is the proportion of subjects alive during three years post-implant. Survival curves of overall mortality and cause-specific mortality were created based on Kaplan-Meier (product limit) estimates. Confidence intervals will be calculated on a log-log scale.||73.2|68.6|
71061273|NCT00273182|141630404|SUPERIORITY_OR_OTHER||Cause specific survival rate at 36 month|85.3|||||TWO_SIDED|95.0|83.3|87.1||No p value for this analysis.|Kaplan-Meier (product limit) estimates|Cause specific survival rate at 36 month.|left-truncation methods were used in the survival analysis for previously implanted subjects.|For cause-specific mortality, the endpoint is the proportion of patients who are alive or do not die due to the progressive heart failure or sudden cardiac death causes during 3 years post-implant. Survival curves of cause-specific mortality were created based on Kaplan-Meier (product limit) estimates. Confidence intervals were calculated on a log-log scale.||87.1|83.3|
70852417|NCT00966875|141193448|SUPERIORITY_OR_OTHER|||||||0.05||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.050
71061274|NCT00273182|141630408|SUPERIORITY_OR_OTHER||event free rate|89.8|||||TWO_SIDED|95.0|88.3|91.2||No p value for this analysis.|Kaplan-Meier (product limit) estimate|||Kaplan-Meier (product limit) estimate of the curve representing the time to first post-implant LV lead related complication were calculated to the first time point where fewer than 50 patients are still at risk. Confidence intervals will be calculated on a log-log scale.||91.2|88.3|
71061275|NCT00856492|141630409|SUPERIORITY_OR_OTHER|||||||0.019|||||||Chi-squared|||||||0.019
71061276|NCT00856492|141630410|SUPERIORITY_OR_OTHER|||||||0.64|||||||Log Rank|||||||0.64
71061277|NCT00856492|141630411|SUPERIORITY_OR_OTHER|||||||0.71|||||||Log Rank|||||||0.71
71061278|NCT05411991|141630425|SUPERIORITY||Net treatment benefit|10.5||||0.357|TWO_SIDED|95.0|-11.9|31.9|||General pairwaise comparison|||||31.9|-11.9|0.357
71061279|NCT05842967|141630440|NON_INFERIORITY|Noninferiority was declared if both the null hypothesis of GMR and the null hypothesis of difference in seroresponse rates were rejected for both RSV A and RSV B serum NTs, with a type I error (2-sided) of 5%.|GMR|1.57|||||TWO_SIDED|95.0|1.396|1.759|||||GMRs (ratio of GMTs from C3671023 SSA to C3671013 immunogenicity subset), 2-sided CI were calculated by exponentiating difference in LS means, corresponding CIs based on regression model. Data reported here is for RSV A.|||1.759|1.396|
71061280|NCT05842967|141630440|NON_INFERIORITY|Noninferiority was declared if both the null hypothesis of GMR and the null hypothesis of difference in seroresponse rates were rejected for both RSV A and RSV B serum NTs, with a type I error (2-sided) of 5%.|GMR|1.52|||||TWO_SIDED|95.0|1.333|1.725|||||GMRs (ratio of GMTs from C3671023 SSA to C3671013 immunogenicity subset), 2-sided CI were calculated by exponentiating difference in LS means, corresponding CIs based on regression model. Data reported here is for RSV B.|||1.725|1.333|
71110082|NCT01475721|141725591|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.764||||0.002|TWO_SIDED|95.0|0.645|0.905|||Regression, Cox||Analysis of time to first exacerbation in efficacy subgroup: Subjects controlled on prior ICS+LABA therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||0.905|0.645|0.002
71110083|NCT01475721|141725591|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.682||||0.071|TWO_SIDED|95.0|0.451|1.034|||Regression, Cox||Analysis of time to first exacerbation in efficacy subgroup: Subjects controlled on prior ICS therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||1.034|0.451|0.071
71110084|NCT01475721|141725591|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.878||||0.373|TWO_SIDED|95.0|0.659|1.17|||Regression, Cox||Analysis of number of asthma exacerbations in efficacy subgroup: Subjects not well-controlled on prior ICS or non-LABA therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||1.170|0.659|0.373
71061281|NCT05842967|141630441|NON_INFERIORITY|Noninferiority was declared if both the null hypothesis of GMR and the null hypothesis of difference in seroresponse rates were rejected for both RSV A and RSV B serum NTs, with a type I error (2-sided) of 5%.|Difference in percentage|5.1|||||TWO_SIDED|95.0|1.2|9.2|||||Difference (C3671023 SSA, compared to C3671013 immunogenicity subset) in proportions, expressed as a percentage; 95% CIs for percentage difference were calculated using exact method based on Miettinen and Nurminen. Data reported here is for RSV A.|||9.2|1.2|
71110085|NCT01475721|141725591|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.864||||0.271|TWO_SIDED|95.0|0.665|1.122|||Regression, Cox||Analysis of number of asthma exacerbations in efficacy subgroup: Subjects not well-controlled on prior ICS+LABA therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||1.122|0.665|0.271
71110086|NCT01475721|141725591|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.755||||0.001|TWO_SIDED|95.0|0.637|0.895|||Regression, Cox||Analysis of number of asthma exacerbations in efficacy subgroup: Subjects controlled on prior ICS+LABA therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||0.895|0.637|0.001
71061282|NCT05842967|141630441|NON_INFERIORITY|Noninferiority was declared if both the null hypothesis of GMR and the null hypothesis of difference in seroresponse rates were rejected for both RSV A and RSV B serum NTs, with a type I error (2-sided) of 5%.|Difference in percentage|8.3|||||TWO_SIDED|95.0|4.2|12.6|||||Difference (C3671023 SSA, compared to C3671013 immunogenicity subset) in proportions, expressed as a percentage; 95% CIs for percentage difference were calculated using exact method based on Miettinen and Nurminen. Data reported here is for RSV B.|||12.6|4.2|
71061283|NCT06192589|141630463|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.43|||<|0.01|TWO_SIDED|90.0|1.34|1.52||Analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of cannabidiol on citalopram compared to citalopram alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.52|1.34|<0.01
71061284|NCT06192589|141630464|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.12|||<|0.01|TWO_SIDED|90.0|1.06|1.17||Analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of cannabidiol on citalopram compared to citalopram alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.17|1.06|<0.01
71110087|NCT01475721|141725591|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.687||||0.075|TWO_SIDED|95.0|0.454|1.04|||Regression, Cox||Analysis of number of asthma exacerbations in efficacy subgroup: Subjects controlled on prior ICS therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||1.040|0.454|0.075
70852418|NCT00966875|141193448|SUPERIORITY_OR_OTHER|||||||0.01||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.010
70936751|NCT00824850|141373422|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.6|||||TWO_SIDED|95.0|3.47|16.75|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||16.75|3.47|
71110088|NCT01475721|141725593|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.776||||0.123|TWO_SIDED|95.0|0.562|1.071|||Regression, Cox|||||1.071|0.562|0.123
71110089|NCT01475721|141725594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.263|||<|0.001|TWO_SIDED|95.0|-0.385|-0.141|||Regression, Cox||Efficacy subgroup: Subjects not well-controlled on prior ICS or non-LABA therapy|||-0.141|-0.385|<0.001
71110090|NCT01475721|141725594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.222||||0.003|TWO_SIDED|95.0|-0.369|-0.076|||Regression, Cox||Efficacy subgroup: Subjects not well-controlled on prior ICS+LABA therapy|||-0.076|-0.369|0.003
71110091|NCT01475721|141725594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.172|||<|0.001|TWO_SIDED|95.0|-0.238|-0.106|||Regression, Cox||Efficacy subgroup: Subjects controlled on prior ICS+LABA therapy|||-0.106|-0.238|<0.001
71110092|NCT01475721|141725594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.251|TWO_SIDED|95.0|-0.216|0.056|||Regression, Cox||Efficacy subgroup: Subjects controlled on prior ICS therapy|||0.056|-0.216|0.251
71110093|NCT00803738|141725595|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For the primary clinical equivalence analysis, a 90% confidence interval was constructed on the difference in the therapeutic cure rates between the Test Product and Reference Product at the Test-of-Cure visit (Visit 3). The interval was calculated using Wald's method with Yates' continuity correction. Clinical equivalence was established if this 90% confidence interval was contained within the interval -0.20 to +0.20 (-20% to +20%).|proportion of subjects in trtmt groups|0.05|||||TWO_SIDED|90.0|-4.3|15.02|||Wald's method with Yates' continuity|||||15.02|-4.30|
71110094|NCT00803738|141725596|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A 90% confidence interval was constructed on the difference in the mycological cure rates between the Test Product and Reference Product at the Test-of-Cure visit (Visit 3). The interval was calculated using Wald's method with Yates' continuity correction. Clinical equivalence was established if this 90% confidence interval was contained within the interval -0.20 to +0.20 (-20% to +20%).|proportion of subjects in trtmt groups|0.05|||||TWO_SIDED|90.0|-4.66|11.49|||Wald's method with Yates' continuity|||||11.49|-4.66|
71110095|NCT00803738|141725597|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A 90% confidence interval was constructed on the difference in the clinical cure rates between the Test Product and Reference Product at the Test-of-Cure visit (Visit 3). The interval was calculated using Wald's method with Yates' continuity correction. Clinical equivalence was established if this 90% confidence interval was contained within the interval -0.20 to +0.20 (-20% to +20%).|proportion of subjects in trtmt groups|0.05|||||TWO_SIDED|90.0|-1.35|16.88|||Wald's method with Yates' continuity|||||16.88|-1.35|
71110096|NCT00387088|141725598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.009|<|0.0001|TWO_SIDED|95.0|0.085|0.118|||ANCOVA|ANCOVA with pooled centre, LABA use, and treatment fitted as main effects and the baseline trough FEV1 as a covariate.||||0.118|0.085|<0.0001
71110097|NCT02848092|141725631|SUPERIORITY||Incidence Risk Ratio|0.64|||<|0.0001|TWO_SIDED|95.0|0.52|0.76|||Generalized Estimating Equation|P value is for the interaction between group (intervention vs. control) and time point (baseline vs. 1 month) using a generalized estimating equation.||||.76|.52|<.0001
71110098|NCT02848092|141725632|SUPERIORITY||Mean Difference (Final Values)|-0.21|||<|0.0001|TWO_SIDED|95.0|-0.29|-0.13|||Generalized Estimating Equation|P value is for the interaction between group (intervention vs. control) and time point (baseline vs. 1 month) using a generalized estimating equation.||||-.13|-.29|<.0001
71110099|NCT02848092|141725633|SUPERIORITY||Incidence Risk Ratio|0.64|||<|0.0001|TWO_SIDED|95.0|0.52|0.76|||Generalized Estimating Equation|P value is for the interaction between group (intervention vs. control) and time point (baseline vs. 6 month) using a generalized estimating equation.||||.76|.52|<.0001
71110100|NCT02848092|141725634|SUPERIORITY||Mean Difference (Final Values)|-0.22|||<|0.0001|TWO_SIDED|95.0|-0.31|-0.13|||Generalized Estimating Equation|P value is for the interaction between group (intervention vs. control) and time point (baseline vs. 6 month) using a generalized estimating equation.||||-.13|-.31|<.0001
71110101|NCT02848092|141725635|SUPERIORITY||Risk Ratio (RR)|0.6|||||TWO_SIDED|95.0|0.41|0.89||||||||.89|.41|
71110102|NCT02848092|141725636|SUPERIORITY||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.61|0.92||||||||.92|.61|
71110103|NCT00913510|141725638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.0||||1||||||The p-value is calculated to the fourth decimal place.|Wilcoxon (Mann-Whitney)|||"H0 : µt = µc versus H1 : µt ≠ µc µt = Exp. relative change of frequency of micturitions per day in test group µc = Exp. relative change of frequency of micturitions per day in control group.~Plan was to have 44 evaluable subjects (90% power) but power of the study was reduced by early termination. It cannot be concluded that there is no difference between the treatment groups due to insufficient power."||||1.0000
71110104|NCT00512278|141725658|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a 25% difference in the rate of SVR between the PEG INF/RBV plus infliximab group (70%) and the PEG INF/RBV (45%) group, a power of 0.85 and an alpha level of 0.05, 75 patients for each group was estimated||||||0.718|||||||t-test, 2 sided|||||||0.718
71110105|NCT00512278|141725660|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a 25% difference in the rate of SVR between the PEG INF/RBV plus infliximab group (70%) and the PEG INF/RBV (45%) group, a power of 0.85 and an alpha level of 0.05, 75 patients for each group was estimated.||||||0.718|TWO_SIDED|95.0||||Univariate and multivariable logistic regression were used for factors associated with an SVR.|t-test, 2 sided|||SVR was the primary outcome to calculate sample size. Assuming a 25% difference in the rate of SVR between the the two groups, a power of 0.85 and an alpha level of 0.05, 75 patients for each group was estimated. This analysis included patients randomized and received at least one dose of study drugs. A 2-sided probability value of \< 0.05 was considered statistically significant. Univariate and multivariable logistic regression were used for factors associated with an SVR.||||0.718
71110106|NCT01718522|141725690|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
71110107|NCT01718522|141725691|OTHER|||||||0.12|||||||Wilcoxon Signed-Rank Test|||||||0.12
71110108|NCT01718522|141725692|OTHER|||||||0.3|||||||Wilcoxon Signed-Rank Test|||||||0.30
71110109|NCT01718522|141725693|OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.03
71110110|NCT01718522|141725694|OTHER|||||||0.04|||||||Wilcoxon Signed-Rank Test|||||||0.04
71110111|NCT01718522|141725695|OTHER|||||||0.35|||||||Wilcoxon Signed-Rank Test|||||||0.35
71110112|NCT01718522|141725696|OTHER|||||||0.001|||||||Wilcoxon Signed-Rank Test|||||||0.001
71110113|NCT01718522|141725697|OTHER|||||||0.61|||||||Wilcoxon Signed-Rank Test|||||||0.61
71110114|NCT01718522|141725698|OTHER|||||||0.1|||||||Wilcoxon Signed-Rank Test|||||||0.1
71110115|NCT01718522|141725699|OTHER|||||||0.22|||||||Wilcoxon Signed-Rank Test|||||||0.22
71110116|NCT01106157|141725706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.277|STANDARD_ERROR_OF_MEAN|0.134||0.017|TWO_SIDED|95.0|0.001|0.552|||t-test, 2 sided|||||0.552|0.001|0.017
71110117|NCT01106157|141725707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.104||0.43|TWO_SIDED|95.0|-0.3|0.13|||t-test, 2 sided|||||0.13|-0.30|0.43
71061285|NCT06192589|141630465|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.06||||0.34|TWO_SIDED|90.0|0.96|1.16|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a single dose of cannabidiol on morphine compared to morphine alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.16|0.96|0.34
71061286|NCT06192589|141630465|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.12||||0.1|TWO_SIDED|90.0|1.0|1.26|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a multiple doses of cannabidiol on morphine compared to morphine alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect.||1.26|1.00|0.10
71061287|NCT06192589|141630466|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.19||||0.02|TWO_SIDED|90.0|1.05|1.35|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a single dose of cannabidiol on morphine compared to morphine alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.35|1.05|0.02
71061288|NCT06192589|141630466|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.11||||0.29|TWO_SIDED|90.0|0.94|1.3|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of multiple doses of cannabidiol on morphine compared to morphine alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.30|0.94|0.29
71061289|NCT06192589|141630473|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.01||||0.47|TWO_SIDED|90.0|0.98|1.05|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a single dose of cannabidiol on morphine compared to morphine alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.05|0.98|0.47
71110118|NCT01106157|141725708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.7||0.37|TWO_SIDED|95.0|-1.64|0.63|||t-test, 2 sided|||||0.63|-1.64|0.37
71110119|NCT01106157|141725709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.064|STANDARD_ERROR_OF_MEAN|0.16||0.69|TWO_SIDED|95.0|-0.4|0.27|||t-test, 2 sided|||||0.27|-0.40|0.69
71110120|NCT01106157|141725710|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.75|STANDARD_ERROR_OF_MEAN|81.3||0.89|TWO_SIDED|95.0|-156.8|180.3|||t-test, 2 sided|||||180.3|-156.8|0.89
71110121|NCT01106157|141725711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.21||0.2|TWO_SIDED|95.0|-0.15|0.7|||t-test, 2 sided|||||0.70|-0.15|0.2
71110122|NCT01106157|141725712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.13|STANDARD_ERROR_OF_MEAN|19.61||0.23|TWO_SIDED|95.0|-64.8|16.7|||t-test, 2 sided|||||16.7|-64.8|0.23
71110123|NCT01106157|141725713|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.037|STANDARD_ERROR_OF_MEAN|0.1||0.79|TWO_SIDED|95.0|-0.18|0.23|||t-test, 2 sided|||||0.23|-0.18|0.79
71110124|NCT01106157|141725714|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-7.67|STANDARD_ERROR_OF_MEAN|5.33||0.163|TWO_SIDED|95.0|-18.7|3.35|||t-test, 2 sided|||||3.35|-18.7|0.163
71110125|NCT02651116|141725738|SUPERIORITY||Rate Ratio|0.7899|STANDARD_ERROR_OF_MEAN|0.0929||0.0449|TWO_SIDED|95.0|0.6273|0.9947||P-Value less than or equal to (\<=) 0.05 level was considered significantly better and P-Value lying between 0.05 less than (\<) p\<=0.1 level was considered marginally significantly better.|Negative Binomial Regression|||Estimated rate ratio (ratio of rate of cough counts per 24 hours for DXM HBr to placebo), and corresponding 95% confidence interval (CI) for DXM HBr versus placebo was obtained from negative binomial model with treatment, study site (pooled), age group, and log-transformed baseline average cough count per hour as factors, with logarithm of the time over which the cough count was evaluated as the offset parameter.||0.9947|0.6273|0.0449
71110126|NCT02651116|141725738|SUPERIORITY|||||||0.6293||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|Negative Binomial Regression|||P-value was obtained from the negative binomial model with treatment, study site (pooled), age group, log-transformed baseline average cough count per hour (based on Baseline Run-in Period) as factors, with interaction term of treatment by age group, and logarithm of the time over which the cough count was evaluated as the offset parameter.||||0.6293
71110127|NCT02651116|141725739|SUPERIORITY||Rate Ratio|0.8048|STANDARD_ERROR_OF_MEAN|0.0912||0.0552|TWO_SIDED|95.0|0.6446|1.0049||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|Negative Binomial Regression|||Estimated rate ratio (ratio of rate of cough counts per specified duration for DXM HBr to placebo, used in evaluation of this outcome measure), and corresponding 95% CI for DXM HBr versus placebo was obtained from negative binomial model with treatment, study site (pooled), age group, and log-transformed baseline average cough count per hour as factors, with logarithm of the time over which the cough count was evaluated as the offset parameter.||1.0049|0.6446|0.0552
71061290|NCT06192589|141630473|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|0.99||||0.73|TWO_SIDED|90.0|0.96|1.03|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of multiple doses of cannabidiol on morphine compared to morphine alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.03|0.96|0.73
71061291|NCT06192589|141630474|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.12||||0.03|TWO_SIDED|90.0|1.03|1.21|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a single dose of cannabidiol on morphine compared to morphine alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.21|1.03|0.03
71061292|NCT06192589|141630474|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|0.98||||0.66|TWO_SIDED|90.0|0.91|1.06|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of multiple doses of cannabidiol on morphine compared to morphine alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.06|0.91|0.66
71061293|NCT06192589|141630475|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies.|Geometric mean ratio|1.08||||0.13|TWO_SIDED|90.0|0.99|1.18|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a single dose of cannabidiol on morphine compared to morphine alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect.||1.18|0.99|0.13
71061294|NCT06192589|141630475|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.26|||<|0.01|TWO_SIDED|90.0|1.17|1.36|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of multiple doses of cannabidiol on morphine compared to morphine alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.36|1.17|<0.01
71061295|NCT06192589|141630476|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.08||||0.12|TWO_SIDED|90.0|1.0|1.17|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a single dose of cannabidiol on morphine compared to morphine alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.17|1.00|0.12
71061296|NCT06192589|141630476|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.11||||0.07|TWO_SIDED|90.0|1.01|1.21|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of multiple doses of cannabidiol on morphine compared to morphine alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.21|1.01|0.07
71061297|NCT01866826|141630480|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||0.51
71061298|NCT01866826|141630481|SUPERIORITY|||||||||||||||||We calculated the proportion of pts with elevated viral levels \>50 copies/ml at each phase of the study.|We estimated that four of the seven patients would have an elevation in viral Ribonucleic Acid (RNA) level \>50 copies/ml.|||
71061299|NCT01866826|141630483|SUPERIORITY||Mean Difference (Net)|0.7872|||||TWO_SIDED|||||||||We calculated the percentage of total lymphocytes that were expressing activation markers at each time point, and compared the differences in the percentages in the Rifaximin and control groups. We used the Wilcoxon test to detect differences between the differences in percentages in the control and Rifaximin groups.||||
71061300|NCT01866826|141630483|SUPERIORITY|||||||0.54|||||||Wilcoxon|||We calculated the percentage of total lymphocytes that were expressing the activation markers at each time point, and compared the differences in the percentages in the Rifaximin and control groups. We used the T-test to detect differences between the differences in percentages in the control group and Rifaximin groups.||||0.54
71061301|NCT02493660|141630485|NON_INFERIORITY|The non-inferiority margin was 10% for all composite endpoints. The primary analysis method was a multilinear regression model for month 12 success with age (\<65 years, ≥65 years), gender, and treatment as the model covariates for the PP population for noninferiority testing.||||||0.0049|||||||Regression, Logistic|Primary analysis method was for month 12 success with age (\<65 years, ≥65 years), sex, and treatment as the model covariates.||||||0.0049
71061302|NCT02493660|141630488|NON_INFERIORITY|The non-inferiority margin was 10% for all composite endpoints.|||||<|0.05|||||||Regression, Logistic|||Results from logistic regression model.||||<0.05
71110128|NCT02651116|141725740|SUPERIORITY||Rate Ratio|0.9551|STANDARD_ERROR_OF_MEAN|0.1491||0.7684|TWO_SIDED|95.0|0.7032|1.2971||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|Negative Binomial Regression|||Estimated rate ratio (ratio of rate of cough counts per specified duration for DXM HBr to placebo, used in evaluation of this outcome measure), and corresponding 95% CI for DXM HBr versus placebo was obtained from negative binomial model with treatment, study site (pooled), age group, and log-transformed baseline average cough count per hour as factors, with logarithm of the time over which the cough count was evaluated as the offset parameter.||1.2971|0.7032|0.7684
71061303|NCT02502149|141630520|OTHER||Adjusted Geometric Mean Ratio|1.08|||||TWO_SIDED|90.0|0.93|1.24|||||The adjusted geometric mean ratio is calculated as 15K (PK2)/2K (PK1).|||1.24|0.93|
71061304|NCT02502149|141630521|OTHER||Adjusted Geometric Mean Ratio|1.01|||||TWO_SIDED|90.0|0.87|1.16|||||The adjusted geometric mean ratio is calculated as 15K (PK2)/2K (PK1).|||1.16|0.87|
71061305|NCT02222922|141630626|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|79.38||||0.3105|TWO_SIDED|90.0|54.01|116.65|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||116.65|54.01|0.3105
71061306|NCT02222922|141630627|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|77.23||||0.2316|TWO_SIDED|90.0|53.8|110.87|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||110.87|53.80|0.2316
71061307|NCT02222922|141630628|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|84.97||||0.4264|TWO_SIDED|90.0|60.05|120.22|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||120.22|60.05|0.4264
71061308|NCT02222922|141630629|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|88.32||||0.5123|TWO_SIDED|90.0|64.03|121.82|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||121.82|64.03|0.5123
71061309|NCT02222922|141630630|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|91.15||||0.824|TWO_SIDED|90.0|44.79|185.5|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||185.50|44.79|0.8240
71061310|NCT02222922|141630631|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|89.58||||0.7922|TWO_SIDED|90.0|43.94|182.62|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||182.62|43.94|0.7922
71061311|NCT02222922|141630632|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|91.17||||0.824|TWO_SIDED|90.0|44.87|185.25|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||185.25|44.87|0.8240
71061312|NCT02222922|141630633|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|102.31||||0.9553|TWO_SIDED|90.0|51.08|204.9|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||204.90|51.08|0.9553
71061313|NCT02222922|141630634|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|81.14||||0.2951|TWO_SIDED|90.0|57.99|113.54|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||113.54|57.99|0.2951
71061314|NCT02222922|141630635|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|84.02||||0.3769|TWO_SIDED|90.0|60.24|117.19|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||117.19|60.24|0.3769
71061315|NCT02222922|141630636|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|86.15||||0.4385|TWO_SIDED|90.0|62.2|119.32|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||119.32|62.20|0.4385
71061316|NCT02222922|141630637|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|88.75||||0.5678|TWO_SIDED|90.0|62.24|126.56|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||126.56|62.24|0.5678
71117642|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
71061317|NCT00116779|141630713|SUPERIORITY_OR_OTHER||Percentage of participants|86.0||||||95.0|73.0|94.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.|||94|73|
71061318|NCT00116779|141630713|SUPERIORITY_OR_OTHER||Percentage of participants|77.0||||||95.0|64.0|88.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.|||88|64|
71061319|NCT00116779|141630714|SUPERIORITY_OR_OTHER||Percentage of participants|90.0||||||95.0|79.0|96.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.|||96|79|
71061320|NCT00116779|141630714|SUPERIORITY_OR_OTHER||Percentage of participants|89.0||||||95.0|78.0|95.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.|||95|78|
71061321|NCT00116779|141630714|SUPERIORITY_OR_OTHER|||||||0.8413||95.0|||||Chi-squared|||||||0.8413
71061322|NCT00116779|141630715|SUPERIORITY_OR_OTHER||Percentage of participants|93.0||||||95.0|82.0|99.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.|||99|82|
71061323|NCT00116779|141630715|SUPERIORITY_OR_OTHER||Percentage of participants|98.0||||||95.0|87.0|100.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.|||100|87|
71061324|NCT00116779|141630716|SUPERIORITY_OR_OTHER|||||||0.904||95.0|||||Log Rank|||Time to 50% reduction||||.904
71061325|NCT00116779|141630716|SUPERIORITY_OR_OTHER|||||||0.778||95.0|||||Log Rank|||Days to 90% reduction||||.778
71061326|NCT02105467|141630726|SUPERIORITY_OR_OTHER||||||<|0.001|||||||One-sided, one-sample exact test|||Superiority of SVR12 in the Immediate Treatment group was tested against the historical response rate of 73%.||||<0.001
71061327|NCT02105467|141630727|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-10.8|9.6|||||Between-treatment difference (Immediate Treatment Group - Deferred Treatment Group) was analyzed using the Miettinen and Nurminen method.|||9.6|-10.8|
71061328|NCT02105467|141630728|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-4.4|2.0|||||Between-treatment difference (Immediate Treatment Group - Deferred Treatment Group) was analyzed using the Miettinen and Nurminen method.|||2.0|-4.4|
71061329|NCT01037218|141630731|SUPERIORITY_OR_OTHER||Difference in LS Means|3.38|||<|0.0001|TWO_SIDED|95.0|1.7|5.07|||ANCOVA|Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||5.07|1.70|<0.0001
71061330|NCT01037218|141630731|SUPERIORITY_OR_OTHER||Difference in LS Means|5.74|||<|0.0001|TWO_SIDED|95.0|4.05|7.43|||ANCOVA|Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||7.43|4.05|<0.0001
71061331|NCT01037218|141630731|SUPERIORITY_OR_OTHER||Difference in LS Means|7.53|||<|0.0001|TWO_SIDED|95.0|5.86|9.2|||ANCOVA|Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||9.20|5.86|<0.0001
71061332|NCT01037218|141630732|SUPERIORITY_OR_OTHER||Difference in LS Means|20.19|||<|0.0001|TWO_SIDED|95.0|13.44|26.93|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||26.93|13.44|<0.0001
71061333|NCT01037218|141630732|SUPERIORITY_OR_OTHER||Difference in LS Means|25.06|||<|0.0001|TWO_SIDED|95.0|18.32|31.81|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||31.81|18.32|<0.0001
71061334|NCT01037218|141630732|SUPERIORITY_OR_OTHER||Difference in LS Means|32.84|||<|0.0001|TWO_SIDED|95.0|26.18|39.5|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||39.50|26.18|<0.0001
71061335|NCT01037218|141630733|SUPERIORITY_OR_OTHER||Difference in LS Means|21.72|||<|0.0001|TWO_SIDED|95.0|14.19|29.24|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||29.24|14.19|<0.0001
71061336|NCT01037218|141630733|SUPERIORITY_OR_OTHER||Difference in LS Means|26.82|||<|0.0001|TWO_SIDED|95.0|19.27|34.37|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||34.37|19.27|<0.0001
71061337|NCT01037218|141630733|SUPERIORITY_OR_OTHER||Difference in LS Means|35.41|||<|0.0001|TWO_SIDED|95.0|27.98|42.83|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||42.83|27.98|<0.0001
70852419|NCT00966875|141193448|SUPERIORITY_OR_OTHER|||||||0.046||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.046
70936752|NCT00824850|141373422|SUPERIORITY_OR_OTHER||geometric mean fold rise|151.4|||||TWO_SIDED|95.0|42.01|545.84|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||545.84|42.01|
71061338|NCT01037218|141630734|SUPERIORITY_OR_OTHER||Difference in LS Means|1.52|||<|0.0001|TWO_SIDED|95.0|0.81|2.23|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||2.23|0.81|<0.0001
71061339|NCT01037218|141630734|SUPERIORITY_OR_OTHER||Difference in LS Means|2.29|||<|0.0001|TWO_SIDED|95.0|1.58|3.0|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||3.00|1.58|<0.0001
71061340|NCT01037218|141630734|SUPERIORITY_OR_OTHER||Difference in LS Means|2.9|||<|0.0001|TWO_SIDED|95.0|2.2|3.6|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||3.60|2.20|<0.0001
71061341|NCT01037218|141630735|SUPERIORITY_OR_OTHER||Difference in LS Means|0.59||||0.0673|TWO_SIDED|95.0|-0.04|1.22|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||1.22|-0.04|0.0673
71061342|NCT01037218|141630735|SUPERIORITY_OR_OTHER||Difference in LS Means|1.53|||<|0.0001|TWO_SIDED|95.0|0.9|2.16|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||2.16|0.90|<0.0001
71061343|NCT01037218|141630735|SUPERIORITY_OR_OTHER||Difference in LS Means|1.53|||<|0.0001|TWO_SIDED|95.0|0.91|2.15|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||2.15|0.91|<0.0001
71061344|NCT01037218|141630736|SUPERIORITY_OR_OTHER||Difference in LS Means|0.36||||0.0566|TWO_SIDED|95.0|-0.01|0.73|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||0.73|-0.01|0.0566
71061345|NCT01037218|141630736|SUPERIORITY_OR_OTHER||Difference in LS Means|0.71||||0.0002|TWO_SIDED|95.0|0.34|1.08|||ANCOVA|P-values obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||1.08|0.34|0.0002
71061346|NCT01037218|141630736|SUPERIORITY_OR_OTHER||Difference in LS Means|0.71||||0.0001|TWO_SIDED|95.0|0.34|1.07|||ANCOVA|P-values obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||1.07|0.34|0.0001
71061347|NCT01037218|141630737|SUPERIORITY_OR_OTHER||Difference in LS Means|0.86||||0.0019|TWO_SIDED|95.0|0.32|1.4|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||1.40|0.32|0.0019
71061348|NCT01037218|141630737|SUPERIORITY_OR_OTHER||Difference in LS Means|1.55|||<|0.0001|TWO_SIDED|95.0|1.01|2.09|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||2.09|1.01|<0.0001
71061349|NCT01037218|141630737|SUPERIORITY_OR_OTHER||Difference in LS Means|2.09|||<|0.0001|TWO_SIDED|95.0|1.55|2.62|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||2.62|1.55|<0.0001
71061350|NCT01037218|141630738|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Armitage test|||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||||<0.0001
71061351|NCT01037218|141630738|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||||<0.0001
71061352|NCT01037218|141630738|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||||<0.0001
71110129|NCT02651116|141725741|SUPERIORITY||Rate Ratio|0.7014|STANDARD_ERROR_OF_MEAN|0.1086||0.022|TWO_SIDED|95.0|0.5178|0.95||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|Negative Binomial Regression|||Estimated rate ratio (ratio of rate of cough counts per specified duration for DXM HBr to placebo, used in evaluation of this outcome measure), and corresponding 95% CI for DXM HBr versus placebo was obtained from negative binomial model with treatment, study site (pooled), age group, and log-transformed baseline average cough count per hour as factors, with logarithm of the time over which the cough count was evaluated as the offset parameter.||0.9500|0.5178|0.0220
71110130|NCT02651116|141725742|SUPERIORITY||Rate Ratio|0.7454|STANDARD_ERROR_OF_MEAN|0.0848||0.0098|TWO_SIDED|95.0|0.5964|0.9316||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|Negative Binomial Regression|||Estimated rate ratio (ratio of rate of cough counts per specified duration for DXM HBr to placebo, used in evaluation of this outcome measure), and corresponding 95% CI for DXM HBr versus placebo was obtained from negative binomial model with treatment, study site (pooled), age group, and log-transformed baseline average cough count per hour as factors, with logarithm of the time over which the cough count was evaluated as the offset parameter.||0.9316|0.5964|0.0098
71061353|NCT01037218|141630738|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||||<0.0001
71061354|NCT01037218|141630739|SUPERIORITY_OR_OTHER||Difference in LS Means|12.65|||<|0.0001|TWO_SIDED|95.0|7.01|18.29|||ANOVA|P-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||18.29|7.01|<0.0001
71110131|NCT02651116|141725743|SUPERIORITY||Difference in least squares mean|-0.221|STANDARD_ERROR_OF_MEAN|0.1324||0.0977|TWO_SIDED|95.0|-0.4831|0.0411||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANCOVA|||Analysis of covariance (ANCOVA) model contained treatment, study site (pooled), log-transformed baseline cough time and age group terms as factors.||0.0411|-0.4831|0.0977
71110132|NCT02651116|141725744|SUPERIORITY||Difference in least squares mean|-0.2881|STANDARD_ERROR_OF_MEAN|0.1224||0.0191|TWO_SIDED|95.0|-0.5287|-0.0475||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||Analysis of variance (ANOVA) model contained treatment, study site (pooled), the corresponding morning baseline cough frequency by participant, and age group included in the model. The statistical analysis was performed on the composite for all categories.||-0.0475|-0.5287|0.0191
71110133|NCT02651116|141725744|SUPERIORITY|||||||0.8355||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||ANOVA model contained treatment, study site (pooled), screening assessment by participant, interaction of treatment by age group and age group included in the model.||||0.8355
71110134|NCT02651116|141725745|SUPERIORITY||Difference in least squares mean|-0.3128|STANDARD_ERROR_OF_MEAN|0.1104||0.0049|TWO_SIDED|95.0|-0.5299|-0.0956||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||ANOVA model contained treatment, study site (pooled), the corresponding morning baseline cough severity by participant, and age group included in the model. The statistical analysis was performed on the composite for all categories.||-0.0956|-0.5299|0.0049
71110135|NCT02651116|141725745|SUPERIORITY|||||||0.8413||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||ANOVA model contained treatment, study site (pooled), screening assessment by participant, interaction of treatment by age group and age group included in the model.||||0.8413
70852420|NCT00966875|141193448|SUPERIORITY_OR_OTHER|||||||0.017||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.017
71061355|NCT01037218|141630739|SUPERIORITY_OR_OTHER||Difference in LS Means|19.61|||<|0.0001|TWO_SIDED|95.0|13.95|25.27|||ANOVA|P-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||25.27|13.95|<0.0001
71061356|NCT01037218|141630739|SUPERIORITY_OR_OTHER||Difference in LS Means|27.01|||<|0.0001|TWO_SIDED|95.0|21.44|32.59|||ANOVA|P-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||32.59|21.44|<0.0001
71061357|NCT01037218|141630740|SUPERIORITY_OR_OTHER||Difference in LS Means|0.44|||<|0.0001|TWO_SIDED|95.0|0.3|0.57|||ANCOVA|P-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||0.57|0.30|<0.0001
71061358|NCT01037218|141630740|SUPERIORITY_OR_OTHER||Difference in LS Means|0.54|||<|0.0001|TWO_SIDED|95.0|0.4|0.68|||ANCOVA|P-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||0.68|0.40|<0.0001
71110136|NCT02651116|141725746|SUPERIORITY||Difference in least squares mean|-0.1483|STANDARD_ERROR_OF_MEAN|0.1337||0.2679|TWO_SIDED|95.0|-0.4112|0.1146||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||ANOVA model contained treatment, study site (pooled), the corresponding morning baseline impact on sleep by participant, and age group included in the model. The statistical analysis was performed on the composite for all categories.||0.1146|-0.4112|0.2679
71110137|NCT02651116|141725746|SUPERIORITY|||||||0.2882||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||ANOVA model contained treatment, study site (pooled), screening assessment by participant, interaction of treatment by age group and age group included in the model.||||0.2882
71110138|NCT02651116|141725747|SUPERIORITY||Difference in least squares mean|-0.2812|STANDARD_ERROR_OF_MEAN|0.1242||0.0242|TWO_SIDED|95.0|-0.5255|-0.0369||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||ANOVA model contained treatment, study site (pooled), the corresponding afternoon baseline cough frequency by participant, and age group included in the model. The statistical analysis was performed on the composite for all categories.||-0.0369|-0.5255|0.0242
71110139|NCT02651116|141725747|SUPERIORITY|||||||0.2892||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||ANOVA model contained treatment, study site (pooled), afternoon baseline assessment by participant, interaction of treatment by age group and age group included in the model.||||0.2892
71061359|NCT01037218|141630740|SUPERIORITY_OR_OTHER||Difference in LS Means|0.83|||<|0.0001|TWO_SIDED|95.0|0.69|0.97|||ANCOVA|P-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||0.97|0.69|<0.0001
71061360|NCT01037218|141630741|SUPERIORITY_OR_OTHER||Difference in LS Means|15.18|||<|0.0001|TWO_SIDED|95.0|10.21|20.14|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||20.14|10.21|<0.0001
71061361|NCT01037218|141630741|SUPERIORITY_OR_OTHER||Difference in LS Means|14.94|||<|0.0001|TWO_SIDED|95.0|9.96|19.92|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||19.92|9.96|<0.0001
71061362|NCT01037218|141630741|SUPERIORITY_OR_OTHER||Difference in LS Means|21.06|||<|0.0001|TWO_SIDED|95.0|16.15|25.96|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||25.96|16.15|<0.0001
71061363|NCT01037218|141630742|SUPERIORITY_OR_OTHER||Difference in LS Means|17.51|||<|0.0001|TWO_SIDED|95.0|10.22|24.81|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||24.81|10.22|<0.0001
71061364|NCT01037218|141630742|SUPERIORITY_OR_OTHER||Difference in LS Means|28.32|||<|0.0001|TWO_SIDED|95.0|21.01|35.62|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||35.62|21.01|<0.0001
71061365|NCT01037218|141630742|SUPERIORITY_OR_OTHER||Difference in LS Means|33.82|||<|0.0001|TWO_SIDED|95.0|26.61|41.02|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||41.02|26.61|<0.0001
71061366|NCT01037218|141630743|SUPERIORITY_OR_OTHER||Difference in LS Means|18.73|||<|0.0001|TWO_SIDED|95.0|11.23|26.23|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||26.23|11.23|<0.0001
71061367|NCT01037218|141630743|SUPERIORITY_OR_OTHER||Difference in LS Means|29.39|||<|0.0001|TWO_SIDED|95.0|21.86|36.92|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||36.92|21.86|<0.0001
71110140|NCT02651116|141725748|SUPERIORITY||Difference in least squares mean|-0.3014|STANDARD_ERROR_OF_MEAN|0.1096||0.0063|TWO_SIDED|95.0|-0.517|-0.0858||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||ANOVA model contained treatment, study site (pooled), the corresponding afternoon baseline cough severity by participant, and age group included in the model. The statistical analysis was performed on the composite for all categories.||-0.0858|-0.5170|0.0063
70936753|NCT00824850|141373422|SUPERIORITY_OR_OTHER||geometric mean fold rise|23.7|||||TWO_SIDED|95.0|8.67|64.54|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||64.54|8.67|
71061368|NCT01037218|141630743|SUPERIORITY_OR_OTHER||Difference in LS Means|34.35|||<|0.0001|TWO_SIDED|95.0|26.94|41.75|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001(NCT00282607).||41.75|26.94|<0.0001
71061369|NCT02676882|141630744|OTHER|A Chi Squared analysis was performed to determine how the rate of relapse in Group 1 (27.3%) compared to that of historical controls in the literature (67.7%). (Cohen, JAMA 2006)||||||0.005||||||A priori threshold for statistical significance: p\<0.05|Chi-squared|||||||0.005
71061370|NCT02676882|141630745|OTHER|A one-way repeated measures ANOVA was used to examine the overall course of Group 2 participants' MADRS scores. (F(6, 29)=5.16, p=0.001).||||||0.001||||||a priori threshold for statistical significance: p \<0.05|ANOVA|||||||0.001
71061371|NCT02568072|141630746|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||||||0.44
71061372|NCT02568072|141630747|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||||||0.71
71061373|NCT02568072|141630748|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||||||0.37
71061374|NCT00897715|141630754|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|TWO_SIDED|||||0.05 is the a priori threshold for statistical significance|ANCOVA|||For the primary specific aim, we will compare the mean percent change on hsCRP between the intervention arm and the placebo arm using linear regression. We anticipate that the intervention will conservatively decrease hsCRP by 54%; whereas, placebo will have no effect. Accordingly, we have estimated that we will need 24 subjects in the experimental arm and 24 controls to have an 80% power, with an alpha of 0.05 to detect the above mentioned effect size.||||0.03
71061375|NCT00897715|141630755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED|||||0.05 is the a priori threshold for statistical significance|ANCOVA|||||||0.01
71061376|NCT02321111|141630768|OTHER|ANOVA||||||0.02|||||||ANOVA|||||||0.02
71061377|NCT00707239|141630800|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-5.4|||||TWO_SIDED|70.0|-21.6|10.9||||||Cure: Confidence interval (CI) was calculated using the Wilson score method, with continuity correction. Clinical response (rates of cure) by using a 2-sided 70 percent (%) CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.||10.9|-21.6|
71061378|NCT00707239|141630800|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.0|||||TWO_SIDED|70.0|-6.1|24.8||||||Cure: CI was calculated using the Wilson score method, with continuity correction. Clinical response (rates of cure) by using a 2-sided 70% CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.||24.8|-6.1|
71061379|NCT00707239|141630801|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.2|||||TWO_SIDED|70.0|-14.3|14.0||||||Cure: CI was calculated using the Wilson score method, with continuity correction. Clinical response (rates of cure) by using a 2-sided 70% CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.||14.0|-14.3|
71061380|NCT00707239|141630801|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.5|||||TWO_SIDED|70.0|4.3|31.8||||||Cure: CI was calculated using the Wilson score method, with continuity correction. Clinical response (rates of cure) by using a 2-sided 70% CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.||31.8|4.3|
71061381|NCT00707239|141630804|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-18.5|||||TWO_SIDED|70.0|-39.6|4.2||||||Eradication: CI was calculated using the Wilson score method, with continuity correction. Microbiological response (rates of eradication) by using a 2-sided 70% CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.||4.2|-39.6|
71061382|NCT00707239|141630804|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|70.0|-23.8|20.9||||||Eradication: CI was calculated using the Wilson score method, with continuity correction. Microbiological response (rates of eradication) by using a 2-sided 70% CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.||20.9|-23.8|
70852421|NCT00966875|141193448|SUPERIORITY_OR_OTHER|||||||0.066||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.066
70941732|NCT04748445|141383935|OTHER||Slope|0.0007046|STANDARD_ERROR_OF_MEAN|3.687||0.0583|TWO_SIDED|90.0|0.00009366|0.001315|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001315|0.00009366|0.0583
71061383|NCT00707239|141630805|SUPERIORITY_OR_OTHER|||||||0.527|TWO_SIDED|||||Statistical testing was done at 5% alpha.|Fisher Exact|||Nausea: p-value was calculated using 2-tail Fischer's exact test.||||0.527
71061384|NCT00707239|141630805|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED|||||Statistical testing was done at 5% alpha.|Fisher Exact|||Vomiting: p-value was calculated using 2-tail Fischer's exact test.||||0.390
71061385|NCT00707239|141630806|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Statistical testing was done at 5% alpha.|Fisher Exact|||p-value was calculated using 2-tail Fischer's exact test.||||1.000
71061386|NCT00707239|141630807|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Statistical testing was done at 5% alpha.|Fisher Exact|||p-value was calculated using 2-tail Fischer's exact test.||||1.000
71061387|NCT00707239|141630813|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0479||||0.78|TWO_SIDED|95.0|0.754|1.46|||Regression, Logistic|||Statistical analysis was carried out between categories, experienced nausea and did not experience nausea.||1.46|0.754|0.78
71061388|NCT00707239|141630813|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84644||||0.356|TWO_SIDED|95.0|0.593|1.21|||Regression, Logistic|||Statistical analysis was carried out between categories, experienced vomiting and did not experience vomiting.||1.21|0.593|0.356
71061389|NCT00707239|141630814|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0054||||0.836|TWO_SIDED|95.0|0.956|1.06|||Regression, Logistic|||Statistical analysis was carried out between categories, cure and failure/indeterminate.||1.06|0.956|0.836
71061390|NCT00707239|141630818|SUPERIORITY_OR_OTHER|||||||0.245|TWO_SIDED|||||Statistical testing was done at 5% alpha.|ANOVA|||Intravenous antibiotic treatment: One-way analysis of variance (ANOVA) with treatment as factor was used to calculate p-value.||||0.245
70936754|NCT00824850|141373422|SUPERIORITY_OR_OTHER||geometric mean fold rise|102.1|||||TWO_SIDED|95.0|32.0|325.4|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||325.40|32.00|
71061391|NCT00707239|141630818|SUPERIORITY_OR_OTHER|||||||0.484|TWO_SIDED|||||Statistical testing was done at 5% alpha.|ANOVA|||Hospital stay: One-way ANOVA with treatment as factor was used to calculate p-value.||||0.484
71061392|NCT00707239|141630818|SUPERIORITY_OR_OTHER|||||||0.192|TWO_SIDED|||||Statistical testing was done at 5% alpha.|ANOVA|||ICU stay: One-way ANOVA with treatment as factor was used to calculate p-value.||||0.192
71061393|NCT01651117|141630821|EQUIVALENCE|Mixed methods ANCOVA with patient random effects, to compare change in HbA1c from baseline to 6 months between treatment and control groups.|Mean Difference (Final Values)|-0.3268|STANDARD_ERROR_OF_MEAN|0.1739||0.0611|TWO_SIDED|95.0|-0.669|0.0154||Subject random effect included because same model was used for analyses of 2 separate follow up periods (baseline to 6 month, and baseline to 12 month, reported separately).|Mixed Models Analysis|Multiple imputation used for intent-to-treat analysis.|Negative parameter estimate means decrease in HbA1c was greater for treatment group than for control group.|||0.0154|-0.6690|0.0611
71061394|NCT02714218|141630861|SUPERIORITY||Odds Ratio (OR)|0.59||||0.0144|TWO_SIDED|95.0|0.38|0.9|||Cochran-Mantel-Haenszel|Two-sided p-value CMH Test for comparison of odds ratio of NIVO 3 + IPI 1 over NIVO 1 + IPI 3||||0.90|0.38|0.0144
71061395|NCT02714218|141630861|SUPERIORITY||Estimated Difference of rates|-12.7|||||TWO_SIDED|95.0|-22.7|-2.6|||||Estimate of NIVO 3 + IPI 1- NIVO 1 + IPI 3 is based on Cochran-Mantel-Haenszel (CMH) method of weighting, adjusting for PD-L1 expression and M stage at screening as entered into the IVRS|||-2.6|-22.7|
71061396|NCT02714218|141630862|SUPERIORITY||Odds Ratio (OR)|0.55||||0.0059|TWO_SIDED|95.0|0.36|0.84|||Cochran-Mantel-Haenszel|Two-sided p-value CMH Test for comparison of odds ratio of NIVO 3 + IPI 1 over NIVO 1 + IPI 3||||0.84|0.36|0.0059
71061397|NCT02714218|141630862|SUPERIORITY||Estimated Difference of rates|-14.4|||||TWO_SIDED|95.0|-24.5|-4.3|||||Estimate of NIVO 3 + IPI 1- NIVO 1 + IPI 3 is based on Cochran-Mantel-Haenszel (CMH) method of weighting, adjusting for PD-L1 expression and M stage at screening as entered into the IVRS|||-4.3|-24.5|
71061398|NCT02714218|141630863|SUPERIORITY||Odds Ratio (OR)|0.8||||0.2923|TWO_SIDED|95.0|0.53|1.21|||Cochran-Mantel-Haenszel||p-value from CMH Test for the comparison of the odds ratio of N3I1 over N1I3|||1.21|0.53|0.2923
71061399|NCT02714218|141630864|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.79|1.47|||||Hazard Ratio is N3I1 over N1I3. (NIVO 3 + IPI 1 (N3I1) over NIVO 1 + IPI 3 (N1I3))|||1.47|0.79|
71061400|NCT02714218|141630865|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.4512|TWO_SIDED|95.0|0.84|1.48|||Log Rank|||||1.48|0.84|0.4512
71061401|NCT01113892|141630881|NON_INFERIORITY|"The non-inferiority margin was 15%. The following null hypothesis (H0) and alternative hypothesis (HA) were tested, with the primary patency rate at 6 months for FUSION Bioline (PF), and the primary patency rate at 6 months for EXXCEL (PE).~H0: PF - PE \< - 0.15; HA: PF - PE \> - 0.15 An exact 1-sided test was used for the observed difference of patency rates between the FUSION Bioline (test) and EXXCEL (control) products."|Mean Difference (Net)|16.4|||<|0.0001|TWO_SIDED|95.0|2.7|29.9||The threshold for significance was p = .05|Exact 1-sided test||Difference = Patency (Fusion Bioline) - Patency (EXXCEL)|It was calculated that 200 participants randomized in a 1:1 fashion would have at least 80% power to detect a difference of 15% in the number of participants with primary patency between FUSION Bioline and EXXCEL groups at 6 months. It was assumed that the ratio of Above-Knee to Below-Knee procedures was 60:40; based on this, the primary patency rate for the combined Above-Knee and Below-Knee patients was 79%. Assumptions included a 10% withdrawal rate prior to the 6-month evaluation.||29.9|2.7|<.0001
70936755|NCT00824850|141373422|SUPERIORITY_OR_OTHER||geometric mean fold rise|31.1|||||TWO_SIDED|95.0|12.71|76.13|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||76.13|12.71|
71061402|NCT01113892|141630882|EQUIVALENCE|Fisher's Exact test was used to evaluate whether subjects with any MALE event or POD were homogeneous across the treatment arms.||||||0.033|ONE_SIDED|95.0|||||Fisher Exact|||The number and percentage of subjects with a MALE or POD event were summarized by treatment group.||||.033
71061403|NCT01113892|141630883|OTHER|||||||0.017|||||||Chi-squared|Proportion of subjects who achieved primary assisted patency for both treatment groups were compared using a Chi-Square test||||||.017
71061404|NCT01113892|141630884|OTHER|||||||0.137|||||||Chi-squared|Proportion of subjects who achieve secondary patency for both treatment groups will be compared using a Chi-Square test||||||.137
71061405|NCT01113892|141630885|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Difference between groups were compared with the Wilcoxon Rank Sum Test||||<.0001
71110141|NCT02651116|141725748|SUPERIORITY|||||||0.3268||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||ANOVA model contained treatment, study site (pooled), afternoon baseline assessment by participant, interaction of treatment by age group and age group included in the model.||||0.3268
70936756|NCT00824850|141373422|SUPERIORITY_OR_OTHER||geometric mean fold rise|18.7|||||TWO_SIDED|95.0|6.82|51.39|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||51.39|6.82|
70936757|NCT00824850|141373422|SUPERIORITY_OR_OTHER||geometric mean fold rise|64.4|||||TWO_SIDED|95.0|37.33|111.18|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||111.18|37.33|
70936758|NCT00824850|141373422|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.1|||||TWO_SIDED|95.0|6.64|18.52|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||18.52|6.64|
70936759|NCT00824850|141373422|SUPERIORITY_OR_OTHER||geometric mean fold rise|41.2|||||TWO_SIDED|95.0|23.09|73.48|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||73.48|23.09|
71061406|NCT01113892|141630887|NON_INFERIORITY|"Repeated 6 month analyses for 12 month results.The non-inferiority margin was 15%. The following null hypothesis (H0) and alternative hypothesis (HA) were tested, with the primary patency rate for FUSION Bioline (PF), and the primary patency rate for EXXCEL (PE).~H0: PF - PE \< - 0.15; HA: PF - PE \> - 0.15 An exact 1-sided test was used for the observed difference of patency rates between the FUSION Bioline (test) and EXXCEL (control) products, with a p-value ≤ .05 indicating significance."|Mean Difference (Net)|9.5||||0.0001|TWO_SIDED|95.0|-4.8|23.0|||Exact 1-sided test|||||23.0|-4.8|.0001
71061407|NCT01113892|141630889|OTHER|||||||0.181|||||||Chi-squared|Proportion of subjects who achieve primary assisted patency for both treatment groups will be compared using a Chi-Square test||||||.181
71110142|NCT02651116|141725749|SUPERIORITY||Difference in least squares mean|-0.2535|STANDARD_ERROR_OF_MEAN|0.1124||0.0247|TWO_SIDED|95.0|-0.4745|-0.0325||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||ANOVA model with treatment, study site (pooled), the baseline assessment in child global question cold assessment by participant and age group included in the model. The statistical analysis was performed on the composite for all categories.||-0.0325|-0.4745|0.0247
71110143|NCT02651116|141725749|SUPERIORITY|||||||0.4093||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||ANOVA model with treatment, study site (pooled), baseline assessment by participant, interaction of treatment by age group and age group included in the model.||||0.4093
70936760|NCT00824850|141373422|SUPERIORITY_OR_OTHER||geometric mean fold rise|479.6|||||TWO_SIDED|95.0|171.63|1339.96|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1339.96|171.63|
70936761|NCT00824850|141373422|SUPERIORITY_OR_OTHER||geometric mean fold rise|76.4|||||TWO_SIDED|95.0|21.63|270.02|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||270.02|21.63|
70936762|NCT00824850|141373422|SUPERIORITY_OR_OTHER||geometric mean fold rise|17.7|||||TWO_SIDED|95.0|7.61|41.08|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||41.08|7.61|
71061408|NCT01113892|141630891|OTHER|||||||0.68|||||||Chi-squared|Proportion of subjects who achieve secondary patency for both treatment groups will be compared using a Chi Square test||||||.68
71061409|NCT00235755|141630910|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Non-parametric rank analysis of covariance adjusted for baseline 28-seizure frequency and stratified by baseline seizure frequency category and region|Non-parametric rank ANCOVA|||||||<0.001
71061410|NCT00235755|141630910|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||Non-parametric rank analysis of covariance adjusted for baseline 28-seizure frequency and stratified by baseline seizure frequency category and region|Non-parametric rank ANCOVA|||||||0.007
71061411|NCT00235755|141630911|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71061412|NCT00235755|141630911|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71110144|NCT02651116|141725750|SUPERIORITY||Difference in least squares mean|0.1266|STANDARD_ERROR_OF_MEAN|0.2196||0.5652|TWO_SIDED|95.0|-0.3081|0.5614||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||Participant: ANOVA model with treatment, study site (pooled), and age group included in the model.||0.5614|-0.3081|0.5652
71110145|NCT02651116|141725750|SUPERIORITY||Difference in least squares mean|-0.1368|STANDARD_ERROR_OF_MEAN|0.1982||0.4914|TWO_SIDED|95.0|-0.5292|0.2556||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||Caregiver: ANOVA model with treatment, study site (pooled), and age group included in the model.||0.2556|-0.5292|0.4914
70936763|NCT00824850|141373423|SUPERIORITY_OR_OTHER||geometric mean fold rise|170.2|||||TWO_SIDED|95.0|22.24|1301.79|||||CI for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1301.79|22.24|
70936764|NCT00824850|141373423|SUPERIORITY_OR_OTHER||geometric mean fold rise|17.8|||||TWO_SIDED|95.0|5.27|59.91|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMRFs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||59.91|5.27|
70936765|NCT00824850|141373423|SUPERIORITY_OR_OTHER||geometric mean fold rise|67.8|||||TWO_SIDED|95.0|18.45|249.02|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||249.02|18.45|
70936766|NCT00824850|141373423|SUPERIORITY_OR_OTHER||geometric mean fold rise|22.2|||||TWO_SIDED|95.0|7.94|61.88|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||61.88|7.94|
71110146|NCT02651116|141725750|SUPERIORITY|||||||0.1029||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||Participant: ANOVA model with treatment, study site (pooled), interaction of treatment by age group and age group included in the model.||||0.1029
71110147|NCT02651116|141725750|SUPERIORITY|||||||0.4736||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||Caregiver: ANOVA model with treatment, study site (pooled), interaction of treatment by age group and age group included in the model.||||0.4736
71110148|NCT02655887|141725825|NON_INFERIORITY|PG of 74%, which was set at 10% (non-inferiority margin) below the weighted mean of primary patency (PP2) rate at 12 month at a combination of 55% (PTS) subjects at primary patency rate of 77.1% and 45% (NIVL) subjects at primary patency rate of 93.4%. When taking into consideration both co-primary efficacy and safety endpoints, with 138 BVS subjects, the overall study power is at least 85%\*99%=84%.|Weighted Z-statistics|88.3||||0.0001|ONE_SIDED|90.0|82.4||||Weighted Z-statistics|||"Hypothesis: H0 :Primary patency rate at 12 months post-index procedure from the overall VENOVO Venous Stent (BVS) patients (PTS and NIVL combined) is at most as good as that of the PG.~Ha: Primary patency rate at 12 months post-index procedure from the overall VENOVO Venous Stent (BVS) patients (PTS and NIVL combined) is better than that of PG."|||82.4|0.0001
71110149|NCT02655887|141725826|NON_INFERIORITY|The primary safety endpoint was evaluated against the PG of 89% which was set at 10% (non-inferiority margin) below the literature-derived average freedom from MAE rate at 30 day of 99%. A one-side p-value is derived based on an exact binomial test. When taking into consideration both co-primary efficacy and safety endpoints, with 138 BVS subjects, the overall study power is at least 85%\*99%=84%.|Exact binomial test|93.5||||0.0322|ONE_SIDED|90.0|89.5||||Exact binomial test|||"Hypothesis: H0: The primary safety endpoint absence from event rate in the VENOVO Venous Stent (BVS) through 30 day at most as large as that of the PG.~Ha: The primary safety endpoint absence from event rate in the VENOVO Venous Stent (BVS) through 30 day is better than that of the PG."|||89.5|0.0322
70852422|NCT00966875|141193450|SUPERIORITY_OR_OTHER|||||||0.538||||||P-value is for Week 12.|Fisher Exact|||||||0.538
70852423|NCT00966875|141193450|SUPERIORITY_OR_OTHER|||||||0.515||||||P-value is for Week 12.|Fisher Exact|||||||0.515
70936767|NCT00824850|141373423|SUPERIORITY_OR_OTHER||geometric mean fold rise|205.5|||||TWO_SIDED|95.0|70.04|602.78|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||602.78|70.04|
70936768|NCT00824850|141373423|SUPERIORITY_OR_OTHER||geometric mean fold rise|90.5|||||TWO_SIDED|95.0|40.28|203.27|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||203.27|40.28|
70941733|NCT04748445|141383935|OTHER||Slope|-1.564|STANDARD_ERROR_OF_MEAN|3.606||0.6654|TWO_SIDED|90.0|-7.54|4.413|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 10 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||4.413|-7.540|0.6654
71110150|NCT02655887|141725827|OTHER|||||||0.001||||||this p value is \< 0.001.|t-test, 2 sided|||"H0: The distribution at the 12-month follow-up remains unimproved compared to baseline.~Ha: The distribution shifts toward lower (less pain) classes."||||0.001
71110151|NCT02655887|141725828|OTHER|||||||0.001||||||p value is \< 0.001|t-test, 2 sided|||||||0.001
70936769|NCT00824850|141373423|SUPERIORITY_OR_OTHER||geometric mean fold rise|91.7|||||TWO_SIDED|95.0|36.25|232.13|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||232.13|36.25|
70936770|NCT00824850|141373423|SUPERIORITY_OR_OTHER||geometric mean fold rise|75.6|||||TWO_SIDED|95.0|47.32|120.91|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||120.91|47.32|
71061413|NCT04052620|141630953|NON_INFERIORITY|Non-inferiority criteria: if the upper 95% Confidence Interval (CI) of Least Square (LS) mean difference was less than 13 mm then DDEA 2.32% gel BID was concluded as non-inferior.|Mean Difference (Final Values)|1.11|STANDARD_ERROR_OF_MEAN|2.09||0.595|TWO_SIDED|95.0|-3.0|5.22|||ANCOVA|||||5.22|-3.00|0.5950
70936771|NCT00824850|141373423|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.7|||||TWO_SIDED|95.0|5.21|14.4|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||14.40|5.21|
71061414|NCT04052620|141630955|OTHER||Mean Difference (Final Values)|-2.43|STANDARD_ERROR_OF_MEAN|2.12||0.2536|TWO_SIDED|95.0|-6.61|1.75|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 3|||1.75|-6.61|0.2536
71061415|NCT04052620|141630955|OTHER||Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|1.76||0.6643|TWO_SIDED|95.0|-4.23|2.7|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 8|||2.70|-4.23|0.6643
71061416|NCT04052620|141630956|OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.19||0.3118|TWO_SIDED|95.0|-1.13|3.54|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 3|||3.54|-1.13|0.3118
71061417|NCT04052620|141630956|OTHER||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|1.35||0.4937|TWO_SIDED|95.0|-3.6|1.74|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||1.74|-3.60|0.4937
71061418|NCT04052620|141630956|OTHER||Mean Difference (Final Values)|1.46|STANDARD_ERROR_OF_MEAN|1.67||0.3825|TWO_SIDED|95.0|-1.83|4.74|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 8|||4.74|-1.83|0.3825
71061419|NCT04052620|141630957|OTHER||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|1.26||0.836|TWO_SIDED|95.0|-2.23|2.75|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 3|||2.75|-2.23|0.8360
71061420|NCT04052620|141630957|OTHER||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|1.24||0.3119|TWO_SIDED|95.0|-3.69|1.18|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||1.18|-3.69|0.3119
71061421|NCT04052620|141630957|OTHER||Mean Difference (Final Values)|1.66|STANDARD_ERROR_OF_MEAN|1.45||0.2535|TWO_SIDED|95.0|-1.2|4.52|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 8|||4.52|-1.20|0.2535
71061422|NCT04052620|141630958|OTHER||Mean Difference (Final Values)|0.74|STANDARD_ERROR_OF_MEAN|1.51||0.6242|TWO_SIDED|95.0|-2.23|3.71|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 3|||3.71|-2.23|0.6242
71061423|NCT04052620|141630958|OTHER||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|2.06||0.8905|TWO_SIDED|95.0|-4.33|3.77|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||3.77|-4.33|0.8905
70936772|NCT00824850|141373423|SUPERIORITY_OR_OTHER||geometric mean fold rise|60.0|||||TWO_SIDED|95.0|31.06|115.92|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||115.92|31.06|
71061424|NCT04052620|141630958|OTHER||Mean Difference (Final Values)|2.12|STANDARD_ERROR_OF_MEAN|2.24||0.3439|TWO_SIDED|95.0|-2.29|6.54|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 8|||6.54|-2.29|0.3439
71061425|NCT04052620|141630959|OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.13||0.1554|TWO_SIDED|95.0|-0.44|0.07|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 3|||0.07|-0.44|0.1554
71061426|NCT04052620|141630959|OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.14||0.0047|TWO_SIDED|95.0|-0.66|-0.12|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||-0.12|-0.66|0.0047
71061427|NCT04052620|141630959|OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.14||0.0082|TWO_SIDED|95.0|-0.66|-0.1|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 8|||-0.10|-0.66|0.0082
71061428|NCT04052620|141630960|OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.09||0.2182|TWO_SIDED|95.0|-0.3|0.07|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 3|||0.07|-0.30|0.2182
71061429|NCT04052620|141630960|OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.09||0.0574|TWO_SIDED|95.0|-0.36|0.01|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||0.01|-0.36|0.0574
71061430|NCT04052620|141630960|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.0194|TWO_SIDED|95.0|-0.37|-0.03|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 8|||-0.03|-0.37|0.0194
71061431|NCT04052620|141630961|OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.821||0.6545|TWO_SIDED|95.0|-1.25|1.986|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 1|||1.986|-1.250|0.6545
71061432|NCT04052620|141630961|OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.721||0.4924|TWO_SIDED|95.0|-1.915|0.924|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||0.924|-1.915|0.4924
71061433|NCT04052620|141630962|OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.823||0.9491|TWO_SIDED|95.0|-1.675|1.57|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 1|||1.570|-1.675|0.9491
71061434|NCT04052620|141630962|OTHER||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|1.451||0.582|TWO_SIDED|95.0|-2.059|3.659|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||3.659|-2.059|0.5820
71061435|NCT00473590|141631002|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.956||||0.9179|TWO_SIDED|95.0|0.404|2.261|||Log Rank|The strata were number of prior cancer treatments (1, \> 1) and β2-microglobulin level (\< 3.5, ≥ 3.5 mg/L).|The hazard ratios were estimated using Cox regression.|Stratified analysis||2.261|0.404|0.9179
71061436|NCT00473590|141631002|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.836||||0.6665|TWO_SIDED|95.0|0.369|1.893||The tests were exploratory because patients were not randomized to the two arms with respect to response status.|Log Rank||The hazard ratios were estimated using Cox regression.|Unstratified analysis.||1.893|0.369|0.6665
71110152|NCT00532844|141725854|SUPERIORITY||Geometric Mean Ratio|1.5|||<|0.001|TWO_SIDED|95.0|1.2|1.8||The model will constitute the independent variables of treatment regimen, treatment sequence, and period as fixed effects, and subject as a random effect. The dependent variable plasma BH4 concentration (AUC0-12 hr) expressed in log transformation.|Mixed Models Analysis|||To determine if administration of saproprterin dihydrochloride administered with Vitamin C results in higher plasma BH4 concentrations when compared with administration of sapropterin dihydrochloride alone in subjects with endothelial dysfunction. The difference in the plasma BH4 concentration (AUC0-12 hr) between the 2 regimens will be compared using a mixed model with a 0.05 level of significance. The difference is represented as the geometric mean ratio.||1.8|1.2|<0.001
71110153|NCT00532844|141725855|SUPERIORITY||Geometric Mean Ratio|0.9||||0.139|TWO_SIDED|95.0|0.7|1.0||The model will constitute the independent variables of treatment regimen, treatment sequence, and period as fixed effects, and subject as a random effect. The dependent variable plasma BH2 concentration (AUC0-12 hr) expressed in log transformation.|Mixed Models Analysis|||To determine if administration of saproprterin dihydrochloride administered with Vitamin C results in higher plasma BH2 when compared with administration of sapropterin dihydrochloride alone in subjects with endothelial dysfunction. The difference in the plasma BH2 concentration (AUC0-12 hr) between the 2 regimens will be compared using a mixed model with a 0.05 level of significance. The difference is represented as the geometric mean ratio.||1.0|0.7|0.139
71110154|NCT00532844|141725855|SUPERIORITY||Geometric Mean Ratio|0.96||||0.57|TWO_SIDED|95.0|0.83|1.11||The model will constitute independent variables of treatment regimen, treatment sequence, and period as fixed effects, and subject as a random effect. The dependent variable Total B concentration (AUC0-12 hr) expressed in log transformation.|Mixed Models Analysis|||To determine if administration of saproprterin dihydrochloride administered with Vitamin C results in Total B (biopterin) when compared with administration of sapropterin dihydrochloride alone in subjects with endothelial dysfunction. The difference in the Total B (biopterin) concentration (AUC0-12 hr) between the 2 regimens will be compared using a mixed model with a 0.05 level of significance. The difference is represented as the geometric mean ratio.||1.11|0.83|0.570
71110155|NCT00532844|141725858|SUPERIORITY|||||||0.593|||||||ANCOVA|The model will have the treatments and the baseline measurement as independent variables and measurement at Day 13 as the dependent variable.||The raw value of PAT obtained from the first period (baseline to Day 13) will be used to compare the two treatments.||||0.593
71110156|NCT02020590|141725885|OTHER||||||||TWO_SIDED|90.0||||||||"The success of ALLOB® treatment was based on the percentage of responders. A treated patient was considered as responding if, at the end of the study (6 months):~* He/she had not required rescue surgery and~* The GDE score as perceived by the patient had improved by at least 25% or the TUS (tomographic union score) as assessed by CT scan had increased by at least 2 points."|The response rate at Month 6 for the 21 patients in the PP population was 100 % (CI: 86.71 - 100.0%). None of the treated patients required rescue surgery. An improvement of GDE score of at least 25% was reported for 16 (76.2%) patients. An increase in TUS of at least 2 points was reported for 16 (76.2%) patients; all patients met at least one of these two criteria.|||
71061437|NCT00473590|141631003|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.633||||0.3134|TWO_SIDED|95.0|0.258|1.552|||Log Rank||The hazard ratios were estimated using Cox regression. The strata were number of prior cancer treatments (1, \> 1) and β2-microglobulin level (\< 3.5, ≥ 3.5 mg/L).|Stratified analysis||1.552|0.258|0.3134
71061438|NCT00473590|141631003|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.608||||0.2634|TWO_SIDED|95.0|0.251|1.468|||Log Rank||The hazard ratios were estimated using Cox regression.|Unstratified analysis||1.468|0.251|0.2634
71061439|NCT00473590|141631004|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.743||||0.2804|TWO_SIDED|95.0|0.432|1.276|||Log Rank|The analysis was stratified for number of prior cancer treatments (1, \> 1) and β2-microglobulin level (\< 3.5, ≥ 3.5 mg/L).|The hazard ratio was estimated using Cox regression. The hazard ratio is relative to BORT + P.|The null hypothesis was that there was no difference between the 2 treatment groups. The alternative hypothesis was that progression-free survival was longer in the BORT + BV group. Stratified Analysis.||1.276|0.432|0.2804
70852424|NCT00966875|141193450|SUPERIORITY_OR_OTHER|||||||0.03||||||P-value is for Week 12.|Fisher Exact|||||||0.030
71061440|NCT00473590|141631004|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.713||||0.2009|TWO_SIDED|95.0|0.424|1.2|||Log Rank||Hazard ratio relative to BORT + P was estimated using Cox regression.|Unstratified Analysis.||1.200|0.424|0.2009
70936773|NCT00824850|141373423|SUPERIORITY_OR_OTHER||geometric mean fold rise|269.8|||||TWO_SIDED|95.0|105.09|692.6|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||692.60|105.09|
71061441|NCT01112059|141631007|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||<|0.05|TWO_SIDED|95.0|0.128|0.633|||Wilcoxon (Mann-Whitney)|||||0.633|0.128|<0.05
71061442|NCT00395161|141631017|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Log Rank|Two-sided logrank test was used, stratified by immune compromised status at study entry (a factor also used to stratify the study randomization)||Null hypothesis was equal median time in both arms. Sample size calculated to yield 90% power to detect a significant effect, assuming inverse hazard rate of 1.5 using two-sided logrank test with alpha=0.05. This required recruitment until 263 patients with an event were enrolled (though the study was terminated early for futility by the DSMB).||||0.29
71061443|NCT00395161|141631018|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||Rate analysis (see comments)|95% CIs were calculated for rates in each arm, and rates compared between arms, via approach of DR Cox, Biometrika (1953), vol 40, pp. 354-60.||Null hypothesis of equal event rates in the two study arms.||||0.81
71061444|NCT00395161|141631019|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.09
70936774|NCT00824850|141373423|SUPERIORITY_OR_OTHER||geometric mean fold rise|37.7|||||TWO_SIDED|95.0|10.85|131.09|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||131.09|10.85|
71061445|NCT00395161|141631020|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Chi-squared|||||||0.07
71061446|NCT00395161|141631021|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||Chi-squared|||||||0.16
71110157|NCT04389866|141725891|SUPERIORITY||Mean Difference (Final Values)|-0.357|STANDARD_DEVIATION|0.864||0.018|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|The df = 13 for arm 1 (jawline injections) analysis of Jawline Rating Scale Assessments given by blinded physician.|Treatment Difference = 4 Weeks after last injection - Baseline|The null hypothesis for the 7 participants placed randomly 1:1 in the jawline injection arm was that there would be no statistically significant change in the blinded physician Jawline Rating Scale Assessment at baseline versus four weeks after last injection.||||0.018
71110158|NCT04389866|141725891|SUPERIORITY||Mean Difference (Final Values)|-0.214|STANDARD_DEVIATION|0.864||0.082|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|The df = 13 for arm 2 (jawline and lateral zygomatic cheek area injections) analysis of Jawline Rating Scale Assessments given by blinded physician.|Treatment Difference = 4 Weeks after last injection - Baseline|The null hypothesis for the 7 participants placed randomly 1:1 in the jawline and lateral (zygomatic) cheek area injections arm was that there would be no statistically significant change in the blinded physician Jawline Rating Scale Assessment at baseline versus four weeks after last injection.||||0.082
71061447|NCT00725920|141631040|SUPERIORITY_OR_OTHER|||||||0.0076||95.0|||||t-test, 2 sided|||||||0.0076
71061448|NCT03918629|141631041|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for geometric mean ratio (GMR) was \>0.67 for both Toxin A and Toxin B.|Adjusted Geometric Mean Ratio|0.82|||||TWO_SIDED|95.0|0.74|0.9|||||Adjusted geometric mean ratio (GMR) was estimated by the ratio of the adjusted GMCs (adjusted for baseline concentrations). CIs based on the student t distribution for the mean or the mean difference in logarithmic scale.|Toxin A||0.90|0.74|
71061449|NCT03918629|141631041|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for GMR was \>0.67 for both Toxin A and Toxin B.|Adjusted Geometric Mean Ratio|0.57|||||TWO_SIDED|95.0|0.49|0.66|||||Adjusted GMR was estimated by the ratio of the adjusted GMCs (adjusted for baseline concentrations). CIs based on the student t distribution for the mean difference in logarithmic scale.|Toxin B||0.66|0.49|
71061450|NCT03918629|141631042|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for the difference was \>-10% for both Toxin A and Toxin B.|Percentage difference|-1.8|||||TWO_SIDED|95.0|-6.4|2.9|||||The difference (2-Dose - 3-Dose) and the associated 95% CIs for the difference were calculated using the Miettinen and Nurminen method.|Toxin A||2.9|-6.4|
70936775|NCT00824850|141373423|SUPERIORITY_OR_OTHER||geometric mean fold rise|44.8|||||TWO_SIDED|95.0|21.31|94.01|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||94.01|21.31|
71061451|NCT03918629|141631042|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for the difference was \>-10% for both Toxin A and Toxin B.|Percentage difference|-16.8|||||TWO_SIDED|95.0|-21.3|-12.2|||||The difference (2-Dose - 3-Dose) and the associated 95% CIs for the difference were calculated using the Miettinen and Nurminen method.|Toxin B||-12.2|-21.3|
71061452|NCT03918629|141631051|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for GMR was \>0.67 for both Toxin A and Toxin B.|Adjusted Geometric Mean Ratio|0.87|||||TWO_SIDED|95.0|0.8|0.95|||||Adjusted GMR was estimated by the ratio of the adjusted GMCs (adjusted for baseline concentrations). CIs based on the student t distribution for the mean or the mean difference in logarithmic scale.|Toxin A||0.95|0.80|
71061453|NCT03918629|141631051|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for GMR was \>0.67 for both Toxin A and Toxin B.|Adjusted Geometric Mean Ratio|0.71|||||TWO_SIDED|95.0|0.62|0.81|||||Adjusted GMR was estimated by the ratio of the adjusted GMCs (adjusted for baseline concentrations). CIs based on the student t distribution for the mean or the mean difference in logarithmic scale.|Toxin B||0.81|0.62|
71061454|NCT03918629|141631052|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for the difference was \>-10% for both Toxin A and Toxin B.|Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.7|1.7|||||The difference (2-Dose - 3-Dose) and the associated 95% CIs for the difference were calculated using the Miettinen and Nurminen method.|Toxin A||1.7|-3.7|
71061455|NCT03918629|141631052|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for the difference was \>-10% for both Toxin A and Toxin B.|Percentage difference|-10.3|||||TWO_SIDED|95.0|-15.1|-5.5|||||The difference (2-Dose - 3-Dose) and the associated 95% CIs for the difference were calculated using the Miettinen and Nurminen method.|Toxin B||-5.5|-15.1|
71061456|NCT01891864|141631053|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin for the comparison of GP2015 with Enbrel with respect to PASI 75 response at Week 12 was based on response rates reported in two pivotal placebo controlled trials (Leonardi et al 2003; Papp et al 2005). Based on the observed effect size of 45-46%, an equivalence margin of 18% was chosen so that at least 60% of the treatment effect seen for Enbrel was maintained. A response rate of 49% was assumed for the comparator treatment Enbrel.|Risk Difference (RD)|-2.3|||||TWO_SIDED|95.0|-9.85|5.3||||||PASI 75 response rate (proportion of patients showing at least a 75% improvement in PASI) after the first 12 weeks of treatment (Treatment Period 1) was the primary endpoint to assess equivalence between GP2015 and Enbrel®. Therapeutic equivalence in terms of PASI75 could be concluded if the exact 95% confidence interval for the difference in the PASI75 rates is completely contained within the interval \[-18%; 18%\]. A logistic regression model was to be employed.||5.3|-9.85|
71061457|NCT01891864|141631054|NON_INFERIORITY_OR_EQUIVALENCE|A MMRM (Mixed Model Repeated Method) was performed on the percentage change from baseline in PASI score from baseline to Week 12. Therapeutic equivalence in terms of the % change from baseline in PASI score was to be determined if the 95% CI for the difference between GP2015 and Enbrel was contained within the interval \[-15%; 15%\].|Mean Difference (Final Values)|-0.64|||||TWO_SIDED|95.0|-3.474|2.204||||||||2.204|-3.474|
71110159|NCT04389866|141725892|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_DEVIATION|0.497||3.1e-07|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|The df = 13 for arm 1 (jawline injections) analysis of Jawline Rating Scale Assessments given by unblinded physician.|Treatment Difference = 4 Weeks after last injection - Baseline|The null hypothesis for the 7 participants placed randomly 1:1 in the jawline injection arm was that there would be no statistically significant change in the unblinded physician Jawline Rating Scale Assessment at baseline versus four weeks after last injection.||||0.00000031
71110160|NCT04389866|141725892|SUPERIORITY||Mean Difference (Final Values)|-0.714|STANDARD_DEVIATION|0.497||7.28e-05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|The df = 13 for jawline and lateral (zygomatic) cheek area injections arm analysis of Jawline Rating Scale Assessments given by unblinded physician.|Treatment Difference = 4 Weeks after last injection - Baseline|The null hypothesis for the 7 participants placed randomly 1:1 in the jawline and lateral (zygomatic) cheek area injections arm was that there would be no statistically significant change in the unblinded physician Jawline Rating Scale Assessment at baseline versus four weeks after last injection.||||0.0000728
70936776|NCT00824850|141373424|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.97|||||TWO_SIDED|95.0|1.31|2.95|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 4: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.95|1.31|
71061458|NCT01891864|141631054|NON_INFERIORITY_OR_EQUIVALENCE|The mean averaged treatment effect (ATE) of percent change from baseline in PASI score up to week 12 was derived for each patient and analyzed using an ANCOVA approach. Therapeutic equivalence in terms of the % change from baseline in PASI score was to be determined if the 95% CI for the difference between GP2015 and Enbrel was contained within the interval \[-15%; 15%\].|Mean Difference (Final Values)|-0.88|||||TWO_SIDED|95.0|-3.61|1.845||||||||1.845|-3.61|
71061459|NCT00868530|141631115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12|TWO_SIDED||||||t-test, 2 sided|||||||0.120
71061460|NCT04199104|141631123|SUPERIORITY||point estimate|19.3||||1.9e-06|TWO_SIDED|95.0|11.2|27.3|||Miettinen and Nurminen method|||||27.3|11.2|0.0000019
71061461|NCT04199104|141631124|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0001129|TWO_SIDED|95.0|0.55|0.83|||Regression, Cox|||||0.83|0.55|0.0001129
71061462|NCT04199104|141631125|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.8819584|TWO_SIDED|95.0|0.91|1.45|||Regression, Cox|||||1.45|0.91|0.8819584
71061463|NCT05120193|141631129|NON_INFERIORITY|The primary safety analysis is performed at a one-sided Type I error rate of α = 0.05. The Farrington-Manning method is used to calculate the upper 95% confidence bound for the difference (QI - QC) between the rate of the primary safety endpoint in the investigational arm (QI) and the rate of the primary safety endpoint in the control arm (QC). If the upper confidence bound is less than 0.08, the study is considered to have demonstrated safety of the investigational device.|Risk Difference (RD)|0.005|||<|0.0001|TWO_SIDED|90.0|-0.028|0.037|||Farrington-Manning|||"The null hypothesis (H0) for the primary safety analysis is that the true rate of primary safety events for the investigational device (QI) is equal to or greater than the true rate for the control device (QC) plus a non-inferiority margin (NIM) of 0.08. The alternative hypothesis (HA) is that the rate of primary safety events for the investigational arm (QI) is less than the rate of primary safety events for the control arm (QC) plus the NIM of 0.08.~H0: QI ≥ QC + 0.08 HA: QI \< QC + 0.08"||0.037|-0.028|<0.0001
71061464|NCT05120193|141631130|NON_INFERIORITY|The primary effectiveness analysis (PSE) is performed at a one-sided Type I error rate of α = 0.025. The Farrington-Manning method is used to calculate the lower 97.5% confidence bound for the difference (PI - PC) between the rate of the PSE in the investigational arm (PI) and the rate of the PSE in the control arm (PC). If the lower confidence bound is greater than -0.15, the study is considered to have demonstrated effectiveness of the investigational device.|Risk Difference (RD)|0.08||||0.025|TWO_SIDED|95.0|-0.009|0.168|||Farrington-Manning|||"The null hypothesis (H0) is that the true rate of primary effectiveness endpoint success (no failures through Day 360) for the investigational device (PI) is less than or equal to the true rate for the control device (PC) minus the NIM of 0.15. The alternative hypothesis (HA) is that the success rate for the investigational arm (PI) is greater than the success rate for the control device (PC) minus the NIM of 0.15.~H0: PI ≤ PC - 0.15 HA: PI \> PC - 0.15"||0.168|-0.009|0.025
71061465|NCT05120193|141631131|SUPERIORITY||Mean Difference (Final Values)|-29.2|||<|0.0001|TWO_SIDED|95.0|-31.7|-26.8|||t-test, 1 sided|||"The null hypothesis (H0) is that the mean total energy application time during the ablation procedure for the investigational device (ETI) is greater than or equal to the mean time for the control device (ETC). The alternative hypothesis (HA) is that the mean total energy application time for the investigational device is less.~H0: ETI ≥ ETC versus HA: ETI \< ETC"||-26.8|-31.7|<0.0001
71061466|NCT05120193|141631132|SUPERIORITY||Mean Difference (Final Values)|-26.8|||<|0.0001|TWO_SIDED|95.0|-32.2|-21.4|||t-test, 1 sided|||"The null hypothesis (H0) is that the mean treatment time for the investigational device (TTI) is greater than or equal to the mean treatment time for the control device (TTC). The alternative hypothesis (HA) is that the mean treatment time for the investigational device is less.~H0: TTI ≥ TTC versus HA: TTI \< TTC"||-21.4|-32.2|<0.0001
71061467|NCT05120193|141631133|SUPERIORITY||Mean Difference (Final Values)|-25.1||||0.025|TWO_SIDED|95.0|-33.0|-17.3|||t-test, 1 sided|||"The null hypothesis (H0) is that the mean procedure time for the investigational device (PTI) is greater than or equal to the mean procedure time for the control device (PTC). The alternative hypothesis (HA) is that the mean procedure time for the investigational device is less.~H0: PTI ≥ PTC versus HA: PTI \< PTC"||-17.3|-33.0|0.025
71061468|NCT01415518|141631173|SUPERIORITY_OR_OTHER||Ratio|1.069|||<|0.0001|TWO_SIDED|95.0|1.043|1.096|||ANCOVA|multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.096|1.043|<.0001
71061469|NCT01415518|141631174|SUPERIORITY_OR_OTHER||Ratio|1.067|||<|0.0001|TWO_SIDED|95.0|1.044|1.09|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.090|1.044|<.0001
71061470|NCT01415518|141631175|SUPERIORITY_OR_OTHER||Ratio|1.068|||<|0.0001||95.0|1.043|1.092|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.092|1.043|<.0001
71061471|NCT01415518|141631176|SUPERIORITY_OR_OTHER||Ratio|1.04||||0.0007|TWO_SIDED|95.0|1.017|1.064|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.064|1.017|0.0007
71061472|NCT01415518|141631177|SUPERIORITY_OR_OTHER||Ratio|1.045|||<|0.0001|TWO_SIDED|95.0|1.024|1.065|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.065|1.024|<.0001
71061473|NCT01415518|141631178|SUPERIORITY_OR_OTHER||Ratio|1.038||||0.0003|TWO_SIDED|95.0|1.017|1.06|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.060|1.017|0.0003
71061474|NCT01415518|141631179|SUPERIORITY_OR_OTHER||Ratio|1.035||||0.0248|TWO_SIDED|95.0|1.004|1.066|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.066|1.004|0.0248
71061475|NCT01415518|141631180|SUPERIORITY_OR_OTHER||Ratio|1.038||||0.0074|TWO_SIDED|95.0|1.01|1.067|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.067|1.010|0.0074
71061476|NCT01415518|141631181|SUPERIORITY_OR_OTHER||Mean Difference (Net)|25.172||||0.0001|TWO_SIDED|95.0|12.733|37.611|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||37.611|12.733|0.0001
71061477|NCT01415518|141631182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.136|||<|0.0001|TWO_SIDED|95.0|12.163|30.11|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||30.110|12.163|<.0001
71061478|NCT01415518|141631183|SUPERIORITY_OR_OTHER||Mean Difference (Net)|23.044|||<|0.0001|TWO_SIDED|95.0|14.927|31.161|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||31.161|14.927|<.0001
71061479|NCT01415518|141631184|SUPERIORITY_OR_OTHER||Mean Difference (Net)|31.513|||<|0.0001|TWO_SIDED|95.0|18.74|44.286|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||44.286|18.740|<.0001
71061480|NCT01415518|141631185|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.322|||<|0.0001|TWO_SIDED|95.0|14.425|34.22|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||34.220|14.425|<.0001
71061481|NCT01415518|141631186|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.168|||<|0.0001|TWO_SIDED|95.0|18.906|35.431|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||35.431|18.906|<.0001
71061482|NCT01415518|141631187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.297||||0.0102|TWO_SIDED|95.0|-0.522|-0.071|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate||||-0.071|-0.522|0.0102
71061483|NCT01415518|141631188|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.343||||0.0004|TWO_SIDED|95.0|-0.533|-0.153|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate||||-0.153|-0.533|0.0004
71110161|NCT04389866|141725893|SUPERIORITY||Mean Difference (Final Values)|-0.571|STANDARD_DEVIATION|0.611||0.014|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|The df = 13 for jawline injections analysis of Jawline Rating Scale Assessments given by subjects.|Treatment Difference = 4 Weeks after last injection - Baseline|The null hypothesis for the 7 participants placed randomly 1:1 in the jawline injection arm was that there would be no statistically significant change in the subjects' Jawline Rating Scale Assessment at baseline versus four weeks after last injection.||||0.014
71110162|NCT04389866|141725893|SUPERIORITY||Mean Difference (Final Values)|-0.714|STANDARD_DEVIATION|0.726||0.0065|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|The df = 13 for jawline and lateral (zygomatic) cheek area injections analysis of Jawline Rating Scale Assessments given by the subjects.|Treatment Difference = 4 Weeks after last injection - Baseline|The null hypothesis for the 7 participants placed randomly 1:1 in the jawline and lateral (zygomatic) cheek area injections arm was that there would be no statistically significant change in the subjects' Jawline Rating Scale Assessment at baseline versus four weeks after last injection.||||0.0065
71110163|NCT01490918|141725916|SUPERIORITY|||||||0.0036||||||The threshold for statistical significance was p=0.05|ANCOVA|Baselin HbA1c as covariate||primary outcome efficacy will be evaluated between group 1(placebo + metfromin + sitagliptin) and 2 (sitagliptine + metformin + acarbose)||||0.0036
71110164|NCT01490918|141725917|SUPERIORITY||||||<|0.0001||||||The threshold for statistical significance was p=0.05|ANCOVA|Baseline HbA1c as covariate||||||<0.0001
71110165|NCT01490918|141725918|SUPERIORITY|||||||0.0185||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline PPG2hr as covariate||||||0.0185
71110166|NCT01490918|141725919|SUPERIORITY|||||||0.0356||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.0356
71061484|NCT01415518|141631189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.342||||0.0002|TWO_SIDED|95.0|-0.523|-0.162|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate||||-0.162|-0.523|0.0002
71061485|NCT01415518|141631190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.279|||<|0.0001|TWO_SIDED|95.0|-0.381|-0.177|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of score as a covariate||||-0.177|-0.381|<.0001
71061486|NCT01415518|141631191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.193||||0.0002|TWO_SIDED|95.0|-0.294|-0.092|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of score as a covariate||||-0.092|-0.294|0.0002
71061487|NCT01415518|141631192|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.208||||0.0001|TWO_SIDED|95.0|-0.308|-0.108|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of score as a covariate||||-0.108|-0.308|0.0001
71061488|NCT01415518|141631193|SUPERIORITY_OR_OTHER||Rate ratio|0.565||||0.0425|TWO_SIDED|95.0|0.325|0.981|||Poisson regression|Poisson regression model with treatment as a factor and the duration time in study as an offset variable||||0.981|0.325|0.0425
71061489|NCT01415518|141631193|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.604||||0.088|TWO_SIDED|95.0|0.339|1.078|||Regression, Cox|Time to the first COPD exacerbation||||1.078|0.339|0.0880
71061490|NCT01415518|141631193|SUPERIORITY_OR_OTHER|||||||0.0845|||||||Log Rank|Time to the first COPD exacerbation||||||0.0845
71061491|NCT01415518|141631194|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.055||||0.2281|TWO_SIDED|95.0|-0.144|0.035|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate||||0.035|-0.144|0.2281
71061492|NCT01415518|141631195|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.122||||0.001|TWO_SIDED|95.0|-0.194|-0.049|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate||||-0.049|-0.194|0.0010
71110167|NCT01490918|141725920|SUPERIORITY|||||||0.8258||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.8258
71110168|NCT01490918|141725921|SUPERIORITY|||||||0.9217||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.9217
71110169|NCT01490918|141725922|SUPERIORITY|||||||0.16||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.16
71110170|NCT01490918|141725923|SUPERIORITY|||||||0.004||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.004
71110171|NCT01490918|141725924|SUPERIORITY|||||||0.292||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.292
71110172|NCT01490918|141725925|SUPERIORITY|||||||0.314||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.314
71110173|NCT01490918|141725926|SUPERIORITY|||||||0.7563||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.7563
71110174|NCT03141255|141725933|OTHER|||||||1|||||||Fisher Exact|||||||1
71110175|NCT03141255|141725934|SUPERIORITY|||||||0.47|||||||Fisher Exact|||||||0.47
71110176|NCT03141255|141725935|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
71110177|NCT03141255|141725936|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
71110178|NCT03141255|141725937|SUPERIORITY|||||||0.029|||||||Mixed Models Analysis|||||||0.029
71110179|NCT03141255|141725938|SUPERIORITY|||||||0.091|||||||Mixed Models Analysis|||||||0.091
71110180|NCT03141255|141725939|SUPERIORITY|||||||0.029|||||||Mixed Models Analysis|||||||0.029
71110181|NCT03141255|141725940|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.7
71110182|NCT03141255|141725941|SUPERIORITY|||||||0.516|||||||Fisher Exact|||||||0.516
71110183|NCT03141255|141725942|OTHER|||||||0.75|||||||Kaplan Meier|||||||0.75
71110184|NCT03141255|141725943|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||||||0.43
71110185|NCT03141255|141725944|SUPERIORITY|||||||0.052|||||||t-test, 2 sided|||||||0.052
70936777|NCT00824850|141373424|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|2.95|||||TWO_SIDED|95.0|1.78|4.9|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 6B: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||4.90|1.78|
70936778|NCT00824850|141373424|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.85|||||TWO_SIDED|95.0|1.25|2.75|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 9V: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.75|1.25|
71061493|NCT01415518|141631196|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.106||||0.0073|TWO_SIDED|95.0|-0.183|-0.029|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate||||-0.029|-0.183|0.0073
71061494|NCT01730053|141631205|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-34.2|||<|0.0001|TWO_SIDED|98.75|-49.2|-19.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Alirocumab group was compared to the corresponding active control group using an appropriate contrast statement.||-19.3|-49.2|<0.0001
71061495|NCT01730053|141631205|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-36.1|||<|0.0001|TWO_SIDED|98.75|-51.5|-20.7||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||As described in statistical analysis 1 of the endpoint.||-20.7|-51.5|<0.0001
71061496|NCT01730053|141631205|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.3|||=|0.0453|TWO_SIDED|98.75|-45.8|5.1||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||As described in statistical analysis 1 of the endpoint.||5.1|-45.8|=0.0453
71061497|NCT01730053|141631205|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.3|||=|0.0136|TWO_SIDED|98.75|-50.9|0.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||As described in statistical analysis 1 of the endpoint.||0.3|-50.9|=0.0136
71061498|NCT01730053|141631206|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-35.2|||<|0.0001|TWO_SIDED|98.75|-47.4|-23.0||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 1.25 % level.||-23.0|-47.4|<0.0001
71061499|NCT01730053|141631206|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-33.2|||<|0.0001|TWO_SIDED|98.75|-45.9|-20.5||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-20.5|-45.9|<0.0001
71061500|NCT01730053|141631206|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-24.5|||=|0.0131|TWO_SIDED|98.75|-49.2|0.2||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||0.2|-49.2|=0.0131
71061501|NCT01730053|141631207|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-35.2|||<|0.0001|TWO_SIDED|98.75|-47.4|-17.9||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-17.9|-47.4|<0.0001
71061502|NCT01730053|141631207|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-32.2|||<|0.0001|TWO_SIDED|98.75|-47.0|-17.5||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-17.5|-47|<0.0001
71061503|NCT01730053|141631208|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-35.3|||<|0.0001|TWO_SIDED|98.75|-48.2|-22.5||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-22.5|-48.2|<0.0001
71061504|NCT01730053|141631208|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-32.3|||<|0.0001|TWO_SIDED|98.75|-45.6|-19.0||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-19.0|-45.6|<0.0001
71061505|NCT01730053|141631209|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-29.2|||<|0.0001|TWO_SIDED|98.75|-40.1|-18.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-18.3|-40.1|<0.0001
71061506|NCT01730053|141631209|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-26.8|||<|0.0001|TWO_SIDED|98.75|-37.9|-15.7||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.7|-37.9|<0.0001
70936779|NCT00824850|141373424|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|2.24|||||TWO_SIDED|95.0|1.11|4.53|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 14: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||4.53|1.11|
70936780|NCT00824850|141373424|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|0.63|||||TWO_SIDED|95.0|0.38|1.05|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 18C: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.05|0.38|
71061507|NCT01730053|141631210|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-30.7|||<|0.0001|TWO_SIDED|98.75|-40.1|-21.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-21.3|-40.1|<0.0001
71061508|NCT01730053|141631210|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.3|||<|0.0001|TWO_SIDED|98.75|-38.0|-18.7||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-18.7|-38.0|<0.0001
71061509|NCT01730053|141631211|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-31.4|||<|0.0001|TWO_SIDED|98.75|-43.9|-18.9||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-18.9|-43.9|<0.0001
71061510|NCT01730053|141631211|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-29.3|||<|0.0001|TWO_SIDED|98.75|-42.1|-16.4||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-16.4|-42.1|<0.0001
70936781|NCT00824850|141373424|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|0.9|||||TWO_SIDED|95.0|0.5|1.62|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 19F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.62|0.50|
70936782|NCT00824850|141373424|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|0.83|||||TWO_SIDED|95.0|0.48|1.43|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 23F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.43|0.48|
70936783|NCT00824850|141373424|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.7|||||TWO_SIDED|95.0|0.96|3.0|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 1: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||3.00|0.96|
71061511|NCT01730053|141631212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-32.8|||<|0.0001|TWO_SIDED|98.75|-43.2|-22.4||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-22.4|-43.2|<0.0001
71061512|NCT01730053|141631212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.2|||<|0.0001|TWO_SIDED|98.75|-39.1|-17.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-17.3|-39.1|<0.0001
71061513|NCT01730053|141631213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.6|||<|0.0001|TWO_SIDED|98.75|-29.4|-11.8||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-11.8|-29.4|<0.0001
71061514|NCT01730053|141631213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.3|||<|0.0001|TWO_SIDED|98.75|-29.3|-11.2||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-11.2|-29.3|<0.0001
71061515|NCT01730053|141631214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.1|||<|0.0001|TWO_SIDED|98.75|-39.7|-16.5||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-16.5|-39.7|<0.0001
71061516|NCT01730053|141631214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-24.0|||<|0.0001|TWO_SIDED|98.75|-35.7|-12.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-12.3|-35.7|<0.0001
71061517|NCT01730053|141631215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-29.5|||<|0.0001|TWO_SIDED|98.75|-42.1|-16.9||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-16.9|-42.1|<0.0001
71061518|NCT01730053|141631215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-24.9|||<|0.0001|TWO_SIDED|98.75|-37.7|-12.2||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-12.2|-37.7|<0.0001
70852425|NCT00966875|141193450|SUPERIORITY_OR_OTHER|||||||0.053||||||P-value is for Week 12.|Fisher Exact|||||||0.053
70852426|NCT00966875|141193450|SUPERIORITY_OR_OTHER|||||||0.393||||||P-value is for Week 12.|Fisher Exact|||||||0.393
70852427|NCT00966875|141193450|SUPERIORITY_OR_OTHER|||||||0.077||||||P-value is for Week 12.|Fisher Exact|||||||0.077
70852428|NCT00966875|141193450|SUPERIORITY_OR_OTHER|||||||0.105||||||P-value is for Week 12.|Fisher Exact|||||||0.105
70936784|NCT00824850|141373424|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.25|||||TWO_SIDED|95.0|0.79|1.96|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 3: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.96|0.79|
70936785|NCT00824850|141373424|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|0.9|||||TWO_SIDED|95.0|0.54|1.52|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 5: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.52|0.54|
71061519|NCT01730053|141631216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.1|||<|0.0001|TWO_SIDED|98.75|-29.4|-10.7||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-10.7|-29.4|<0.0001
71061520|NCT01730053|141631216|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-17.2|||<|0.0001|TWO_SIDED|98.75|-26.7|-7.7||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-7.7|-26.7|<0.0001
71110186|NCT01925768|141725964|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|17.7||||0.004|TWO_SIDED|95.0|6.2|29.3||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights. The CI is based on a normal approximation.|||29.3|6.2|0.0040
70936786|NCT00824850|141373424|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.81|||||TWO_SIDED|95.0|0.98|3.34|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 6A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||3.34|0.98|
70936787|NCT00824850|141373424|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.72|||||TWO_SIDED|95.0|1.05|2.83|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 7F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.83|1.05|
70936788|NCT00824850|141373424|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.06|||||TWO_SIDED|95.0|0.67|1.66|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 19A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.66|0.67|
70936789|NCT00824850|141373425|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|2.18|||||TWO_SIDED|95.0|1.26|3.79|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 4: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||3.79|1.26|
70936790|NCT00824850|141373425|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|3.13|||||TWO_SIDED|95.0|1.84|5.32|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 6B: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||5.32|1.84|
70936791|NCT00824850|141373425|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.68|||||TWO_SIDED|95.0|1.13|2.51|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 9V: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.51|1.13|
71061521|NCT01730053|141631217|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|12.4|||<|0.0001|TWO_SIDED|98.75|2.6|59.5||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||59.5|2.6|<0.0001
71110187|NCT01925768|141725965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.103||||0.1677|TWO_SIDED|95.0|-0.251|0.044|||Mixed Models Analysis|Those with a baseline and at least 1 postbaseline value at the PBO controlled phase were counted with mixed effects model for repeated measure (MMRM)|The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate|||0.044|-0.251|0.1677
70936792|NCT00824850|141373425|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.96|||||TWO_SIDED|95.0|0.95|4.07|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 14: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||4.07|0.95|
71061522|NCT01730053|141631217|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.4|||=|0.0007|TWO_SIDED|98.75|1.8|40.5||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||40.5|1.8|=0.0007
71061523|NCT01730053|141631218|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|15.6|||<|0.0001|TWO_SIDED|98.75|2.58|88.2||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||88.2|2.58|<0.0001
70936793|NCT00824850|141373425|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|0.9|||||TWO_SIDED|95.0|0.51|1.56|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 18C: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.56|0.51|
70936794|NCT00824850|141373425|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.58|||||TWO_SIDED|95.0|0.93|2.66|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 19F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.66|0.93|
70936795|NCT00824850|141373425|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.62|||||TWO_SIDED|95.0|0.97|2.73|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 23F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.73|0.97|
71117643|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
71117644|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
71061524|NCT01730053|141631218|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|9.9|||=|0.001|TWO_SIDED|98.75|1.7|56.7||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||56.7|1.7|=0.001
71061525|NCT01730053|141631219|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|18.6|||<|0.0001|TWO_SIDED|98.75|3.6|96.2||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||96.2|3.6|<0.0001
71061526|NCT01730053|141631219|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|11.6|||<|0.0001|TWO_SIDED|98.75|2.5|53.1||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||53.1|2.5|<0.0001
71061527|NCT01730053|141631220|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|20.3|||<|0.0001|TWO_SIDED|98.75|2.4|67.7||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||67.7|2.4|<0.0001
71061528|NCT01730053|141631220|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|12.7|||=|0.0002|TWO_SIDED|98.75|2.4|67.7||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||67.7|2.4|=0.0002
71061529|NCT01730053|141631221|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-23.9|||<|0.0001|TWO_SIDED|98.75|-38.6|-9.1||Threshold for significance ≤ 0.0125.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-9.1|-38.6|<0.0001
71061530|NCT01730053|141631221|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-23.6|||=|0.0001|TWO_SIDED|98.75|-39.0|-8.2||Threshold for significance ≤ 0.0125.|Regression, Robust|||Analysis description as per the statistical analysis 1 of this endpoint.||-8.2|-39.0|=0.0001
71061531|NCT01730053|141631222|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|7.4|||=|0.0311|TWO_SIDED|98.75|-1.2|16.1||Threshold for significance ≤ 0.0125.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a robust regression model.||16.1|-1.2|=0.0311
71061532|NCT05085834|141631233|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.71|STANDARD_ERROR_OF_MEAN|0.14|<|0.01|TWO_SIDED|95.0|0.43|0.98|||linear combination of coefficients|||effect of Zinc supplementation on ln(Zinc, μg/dL)||0.98|0.43|<0.01
71061533|NCT05085834|141631234|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.002|STANDARD_ERROR_OF_MEAN|0.29||1|TWO_SIDED|95.0|-0.57|0.57|||linear combination of coefficients|||effect of Zinc supplementation on ln(hsCRP ng/mL)||0.57|-0.57|1.00
71061534|NCT05085834|141631234|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.08|TWO_SIDED|95.0|-0.18|0.01|||linear combination of coefficients|||effect of Zinc supplementation on ln(sCD14, ng/mL)||0.01|-0.18|0.08
71061535|NCT05085834|141631234|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.03|STANDARD_ERROR_OF_MEAN|0.09||0.77|TWO_SIDED|95.0|-0.21|0.15|||linear combination of coefficients|||effect of Zinc supplementation on ln(sCD163, ng/mL)||0.15|-0.21|0.77
71110188|NCT01925768|141725966|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|18.5||||0.004|TWO_SIDED|95.0|6.3|30.6||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel|Those who withdrew early or who did not have sufficient data at Week 16 were counted as non-responders.|Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights. The CI is based on a normal approximation.|||30.6|6.3|0.0040
71061536|NCT05085834|141631234|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.2|STANDARD_ERROR_OF_MEAN|0.15||0.19|TWO_SIDED|95.0|-0.1|0.5|||linear combination of coefficients|||effect of Zinc supplementation on ln(D-dimer, ng/mL)||0.50|-0.10|0.19
71061537|NCT05085834|141631234|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.19|STANDARD_ERROR_OF_MEAN|0.11||0.1|TWO_SIDED|95.0|-0.41|0.04|||linear combination of coefficients|||effect of Zinc supplementation on ln(VCAM, ng/mL)||0.04|-0.41|0.10
71061538|NCT05085834|141631234|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.41|STANDARD_ERROR_OF_MEAN|20.19||0.98|TWO_SIDED|95.0|-39.16|39.98|||linear combination of coefficients|||effect of Zinc supplementation on ln(ICAM, ng/mL)||39.98|-39.16|0.98
71061539|NCT05085834|141631235|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.55|TWO_SIDED|95.0|-0.09|0.16|||linear combination of coefficients|||effect of Zinc supplementation on ln(sTNF-RI , pg/mL)||0.16|-0.09|0.55
71110189|NCT01925768|141725967|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5||||0.0051|TWO_SIDED|95.0|-0.85|-0.15|||Mixed Models Analysis||The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate.|||-0.15|-0.85|0.0051
71110190|NCT01925768|141725968|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.68||||0.0167|TWO_SIDED|95.0|0.49|4.88|||Mixed Models Analysis|Those with a baseline and at least 1 postbaseline value at the PBO controlled phase were counted with mixed effects model for repeated measure (MMRM)|The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate|||4.88|0.49|0.0167
71110191|NCT01925768|141725969|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.4||||0.0039|TWO_SIDED|95.0|1.1|5.7||Based on an MMRM model for the change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD use and baseline Oral Corticosteroids use as factors and the baseline value as a covariate.|Mixed Models Analysis|||2-sided 95% CI for the difference in LS mean.||5.70|1.10|0.0039
71110192|NCT01925768|141725970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.0||||0.012|TWO_SIDED|95.0|-21.5|10.2|||Sign test|p-value based on distribution free signed rank test||||10.2|-21.5|0.012
71110193|NCT01925768|141725971|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|19.7||||0.0016|TWO_SIDED|95.0|8.0|31.3||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline oral corticosteroids (prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights. The CI is based on a normal approximation.|||31.3|8.0|0.0016
71110194|NCT01925768|141725972|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15||||0.0229|TWO_SIDED|95.0|-0.279|-0.021|||Mixed Models Analysis||The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate|||-0.021|-0.279|0.0229
71110195|NCT01925768|141725973|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.35|||Mixed Models Analysis||The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate|||-0.35|-1.00|<0.0001
71110196|NCT01925768|141725974|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.46||||0.0039|TWO_SIDED|95.0|1.13|5.8|||Mixed Models Analysis||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|||5.80|1.13|0.0039
71110197|NCT01925768|141725975|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann|10.0||||0.0168|TWO_SIDED|95.0|0.0|20.0|||Stratified Van Elteren test|p-value based on stratified Van Elteren test, using 2 stratification factors: previous DMARD use and baseline Oral Corticosteroids|Location shift and 95% CI based on Hodges-Lehmann for between treatment median estimates.|||20.0|0.0|0.0168
71110198|NCT01925768|141725976|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|20.7||||0.0015|TWO_SIDED|95.0|8.5|32.8||2 sided-p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|||32.8|8.5|0.0015
71110199|NCT01925768|141725977|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|9.7||||0.0252|TWO_SIDED|95.0|1.6|17.7||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 2; 2-sided 95% CI is based on a normal approximation to the weighted average||17.7|1.6|0.0252
71110200|NCT01925768|141725977|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|8.6||||0.1121|TWO_SIDED|95.0|-1.7|18.9||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 4; 2-sided 95% CI is based on a normal approximation to the weighted average||18.9|-1.7|0.1121
71061540|NCT05085834|141631235|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.004|STANDARD_ERROR_OF_MEAN|0.07||0.95|TWO_SIDED|95.0|-0.13|0.13|||linear combination of coefficients|||effect of Zinc supplementation on ln(sTNF-RII, pg/m)||0.13|-0.13|0.95
71061541|NCT05085834|141631235|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.07|STANDARD_ERROR_OF_MEAN|0.19||0.73|TWO_SIDED|95.0|-0.3|0.43|||linear combination of coefficients|||effect of Zinc supplementation on ln(IL-6, pg/mL)||0.43|-0.30|0.73
71061542|NCT05085834|141631235|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.12|STANDARD_ERROR_OF_MEAN|0.18||0.48|TWO_SIDED|95.0|-0.22|0.47|||linear combination of coefficients|||effect of Zinc supplementation on ln(IP-10, pg/mL)||0.47|-0.22|0.48
71061543|NCT05085834|141631236|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|1819.18|STANDARD_ERROR_OF_MEAN|8530.03||0.83|TWO_SIDED|95.0|-14899.37|18537.74|||linear combination of coefficients|||effect of Zinc supplementation on ln(OxLDL, U/L)||18537.74|-14899.37|0.83
71061544|NCT05085834|141631237|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.01|STANDARD_ERROR_OF_MEAN|0.07||0.84|TWO_SIDED|95.0|-0.12|0.15|||linear combination of coefficients|||effect of Zinc supplementation on ln(Non-HDL Cholesterol (mg/dL))||0.15|-0.12|0.84
71061545|NCT05085834|141631237|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.08|STANDARD_ERROR_OF_MEAN|0.06||0.18|TWO_SIDED|95.0|-0.19|0.04|||linear combination of coefficients|||effect of Zinc supplementation on ln(HDL (mg/dL))||0.04|-0.19|0.18
71110201|NCT01925768|141725977|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|17.8||||0.0036|TWO_SIDED|95.0|6.2|29.3||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 6; 2-sided 95% CI is based on a normal approximation to the weighted average||29.3|6.2|0.0036
71110202|NCT01925768|141725977|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|12.7||||0.0392|TWO_SIDED|95.0|0.8|24.6||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 8; 2-sided 95% CI is based on a normal approximation to the weighted average||24.6|0.8|0.0392
71061546|NCT05085834|141631237|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.02|STANDARD_ERROR_OF_MEAN|0.09||0.84|TWO_SIDED|95.0|-0.19|0.15|||linear combination of coefficients|||effect of Zinc supplementation on ln(LDL (mg/dL))||0.15|-0.19|0.84
71061547|NCT05085834|141631237|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.07|STANDARD_ERROR_OF_MEAN|0.11||0.55|TWO_SIDED|95.0|-0.15|0.29|||linear combination of coefficients|||effect of Zinc supplementation on ln(VLDL (mg/dL))||0.29|-0.15|0.55
71061548|NCT05085834|141631237|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.78|TWO_SIDED|95.0|-0.11|0.09|||linear combination of coefficients|||effect of Zinc supplementation on ln(Cholesterol (mg/dl))||0.09|-0.11|0.78
71061549|NCT05085834|141631237|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.07|STANDARD_ERROR_OF_MEAN|0.12||0.58|TWO_SIDED|95.0|-0.17|0.31|||linear combination of coefficients|||effect of Zinc supplementation on ln(Triglycerides (mg/dL))||0.31|-0.17|0.58
70936796|NCT00824850|141373425|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.41|||||TWO_SIDED|95.0|0.83|2.39|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 1: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.39|0.83|
71061550|NCT05085834|141631237|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.44|STANDARD_ERROR_OF_MEAN|0.47||0.35|TWO_SIDED|95.0|-1.36|0.48|||linear combination of coefficients|||effect of Zinc supplementation on Metabolic Syndrome||0.48|-1.36|0.35
71061551|NCT05085834|141631238|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.06|STANDARD_ERROR_OF_MEAN|0.07||0.36|TWO_SIDED|95.0|-0.07|0.2|||linear combination of coefficients|||effect of Zinc supplementation on ln(Chol:HDL Ratio)||0.20|-0.07|0.36
71061552|NCT05085834|141631239|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.35|STANDARD_ERROR_OF_MEAN|2.01||0.86|TWO_SIDED|95.0|-4.29|3.6|||linear combination of coefficients|||effect of Zinc supplementation on BMI (kg/m2)||3.60|-4.29|0.86
71061553|NCT05085834|141631240|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.74|TWO_SIDED|95.0|-0.08|0.05|||linear combination of coefficients|||effect of Zinc supplementation on ln(Waist-umbilicus (cm))||0.05|-0.08|0.74
71061554|NCT05085834|141631241|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-2.99|STANDARD_ERROR_OF_MEAN|12.23||0.81|TWO_SIDED|95.0|-26.97|20.99|||linear combination of coefficients|||effect of Zinc supplementation on Weight (lbs)||20.99|-26.97|0.81
71061555|NCT05085834|141631242|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.41|TWO_SIDED|95.0|-0.07|0.03|||linear combination of coefficients|||effect of Zinc supplementation on ln(Systolic blood pressure (mmHg))||0.03|-0.07|0.41
71061556|NCT05085834|141631242|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-1.68|STANDARD_ERROR_OF_MEAN|2.06||0.42|TWO_SIDED|95.0|-5.71|2.36|||linear combination of coeff|||effect of Zinc supplementation on Diastolic blood pressure (mmHg)||2.36|-5.71|0.42
71061557|NCT05085834|141631243|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.04|STANDARD_ERROR_OF_MEAN|0.11||0.7|TWO_SIDED|95.0|-0.26|0.17|||linear combination of coefficients|||effect of Zinc supplementation on ln(10 year ASCVD (%))||0.17|-0.26|0.70
71061558|NCT05085834|141631244|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.62|TWO_SIDED|95.0|-0.17|0.1|||linear combination of coefficients|||effect of Zinc supplementation on Reactive Hyperemic Index||0.10|-0.17|0.62
71061559|NCT05085834|141631244|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.59|STANDARD_ERROR_OF_MEAN|2.43||0.81|TWO_SIDED|95.0|-4.19|5.36|||linear combination of coefficients|||effect of Zinc supplementation on Augmentation Index||5.36|-4.19|0.81
71061560|NCT05085834|141631245|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.02|STANDARD_ERROR_OF_MEAN|0.14||0.9|TWO_SIDED|95.0|-0.26|0.3|||linear combination of coefficients|||effect of Zinc supplementation on ln(IFAB (pg/mL))||0.30|-0.26|0.90
70936797|NCT00824850|141373425|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.44|||||TWO_SIDED|95.0|0.89|2.34|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 3: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.34|0.89|
70936798|NCT00824850|141373425|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.06|||||TWO_SIDED|95.0|0.68|1.64|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 5: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.64|0.68|
70936799|NCT00824850|141373425|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.88|||||TWO_SIDED|95.0|1.05|3.35|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 6A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||3.35|1.05|
70936800|NCT00824850|141373425|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.48|||||TWO_SIDED|95.0|0.9|2.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 7F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.44|0.90|
70936801|NCT00824850|141373425|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.11|||||TWO_SIDED|95.0|0.75|1.66|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 19A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.66|0.75|
70936802|NCT00824850|141373426|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.8|||||TWO_SIDED|95.0|0.5|1.17|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 4: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.17|0.50|
71061561|NCT05085834|141631245|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.18|STANDARD_ERROR_OF_MEAN|0.15||0.24|TWO_SIDED|95.0|-0.12|0.47|||linear combination of coefficients|||effect of Zinc supplementation on ln(BDG (pg/mL))||0.47|-0.12|0.24
71061562|NCT05085834|141631246|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.69|TWO_SIDED|95.0|-0.21|0.32|||v|||effect of Zinc supplementation on ln(LBP (ng/mL))||0.32|-0.21|0.69
71061563|NCT05085834|141631246|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.09|STANDARD_ERROR_OF_MEAN|0.13||0.49|TWO_SIDED|95.0|-0.16|0.34|||linear combination of coefficients|||effect of Zinc supplementation on ln(Zonulin (ng/mL)||0.34|-0.16|0.49
71061564|NCT02157935|141631269|SUPERIORITY_OR_OTHER||Rate ratio|0.76||||0.0059|TWO_SIDED|95.0|0.62|0.92|||Negative binomial model|||||0.92|0.62|0.0059
71061565|NCT02157935|141631270|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0164|TWO_SIDED|95.0|0.64|0.96|||Regression, Cox|||||0.96|0.64|0.0164
71061566|NCT02157935|141631271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.343||||0.007|TWO_SIDED|95.0|-2.318|-0.368|||Mixed Models Analysis|||||-0.368|-2.318|0.0070
71061567|NCT02157935|141631272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.0091|TWO_SIDED|95.0|0.008|0.053|||Mixed Models Analysis|||||0.053|0.008|0.0091
70936803|NCT00824850|141373426|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.1|||||TWO_SIDED|95.0|0.7|1.73|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 6B: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.73|0.70|
71061568|NCT02157935|141631273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.203||||0.0082|TWO_SIDED|95.0|-0.353|-0.053|||ANCOVA|||||-0.053|-0.353|0.0082
71061569|NCT02157935|141631274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.028||||0.0048|TWO_SIDED|95.0|-0.048|-0.009|||ANCOVA|||||-0.009|-0.048|0.0048
70936804|NCT00824850|141373426|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.8|||||TWO_SIDED|95.0|0.61|1.15|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 9V: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.15|0.61|
70936805|NCT00824850|141373426|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.8|||||TWO_SIDED|95.0|0.56|1.25|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 14: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.25|0.56|
71061570|NCT02717507|141631299|OTHER||Slope|0.163|STANDARD_ERROR_OF_MEAN|0.112||0.15|TWO_SIDED|95.0|-0.057|0.383|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment was considered efficacious if the group by time interaction for LVWT/Dz was statistically significant at a two-sided p\<0.05 and the expected LVWT/Dz was higher for carvedilol than placebo over time.|The null hypothesis is that change in LVWT/Dz across time do not vary by arm. Assuming a type I error=0.05, 2-sided test, 15% attrition/year, and correlation range of 0.6-0.8 between measurements, we projected that a sample size of 125/arm would provide 80% power to detect an effect size of 0.23-0.32 for LVWT/Dz at 24m.||0.383|-0.057|0.15
71061571|NCT02717507|141631300|OTHER||Slope|-3.764|STANDARD_ERROR_OF_MEAN|1.705||0.03|TWO_SIDED|95.0|-7.105|-0.424|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||-0.424|-7.105|0.03
70936806|NCT00824850|141373426|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.8|||||TWO_SIDED|95.0|0.51|1.4|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 18C: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.40|0.51|
71061572|NCT02717507|141631301|OTHER||Slope|-0.045|STANDARD_ERROR_OF_MEAN|0.023||0.05|TWO_SIDED|95.0|-0.09|0.001|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||0.001|-0.09|0.05
71061573|NCT02717507|141631302|OTHER||Slope|-2.194|STANDARD_ERROR_OF_MEAN|1.605||0.17|TWO_SIDED|95.0|-5.34|0.951|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment was considered efficacious if the group by time interaction for LVESV was statistically significant at a two-sided p\<0.05 and the expected LVESV was lower for carvedilol than placebo over time.|||0.951|-5.34|0.17
71061574|NCT02717507|141631303|OTHER||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.01|TWO_SIDED|95.0|-141.0|-0.024|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||-0.024|-0141|0.01
71061575|NCT02717507|141631304|OTHER||Slope|-2.397|STANDARD_ERROR_OF_MEAN|2.603||0.36|TWO_SIDED|95.0|-7.499|2.704|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment was considered efficacious if the group by time interaction for LVEDV was statistically significant at a two-sided p\<0.05 and the expected LVEDV was lower for carvedilol than placebo over time.|||2.704|-7.499|0.36
71061576|NCT02717507|141631305|OTHER||Slope|0.433|STANDARD_ERROR_OF_MEAN|0.799||0.59|TWO_SIDED|95.0|-1.134|1.999|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||1.999|-1.134|0.59
71061577|NCT02717507|141631306|OTHER||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.302||0.84|TWO_SIDED|95.0|-0.652|0.532|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment can be considered beneficial if the mean difference (treatment - control) slope is positive|||0.532|-0.652|0.84
71061578|NCT02717507|141631307|OTHER||Slope|0.259|STANDARD_ERROR_OF_MEAN|0.373||0.49|TWO_SIDED|95.0|-0.472|0.991|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment was considered efficacious if the group by time interaction for LVEF was statistically significant at a two-sided p\<0.05 and the expected LVEF was higher for carvedilol than placebo over time.|The null hypothesis is that change in LVEF across time do not vary by arm. Assuming a type I error=0.05, 2-sided test, 15% attrition/year, and correlation range of 1.2-1.6 between measurements, we projected that a sample size of 125/arm would provide 80% power to detect an effect size of 0.23-0.32 for LVEF at 24m.||0.991|-0.472|0.49
71061579|NCT02717507|141631308|OTHER||Slope|0.009|STANDARD_ERROR_OF_MEAN|0.038||0.82|TWO_SIDED|95.0|-0.065|0.082|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||0.082|-0.065|0.82
71061580|NCT02717507|141631309|OTHER||Slope|2.121|STANDARD_ERROR_OF_MEAN|1.79||0.24|TWO_SIDED|95.0|-1.387|5.63|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment can be considered beneficial if the mean difference (treatment - control) slope is negative|||5.63|-1.387|0.24
71061581|NCT02717507|141631310|OTHER||Slope|5.113|STANDARD_ERROR_OF_MEAN|8.532||0.55|TWO_SIDED|95.0|-11.608|21.835|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment can be considered beneficial if the mean difference (treatment - control) slope is negative|||21.835|-11.608|0.55
71061582|NCT02717507|141631311|OTHER||Slope|-0.001|STANDARD_ERROR_OF_MEAN|0.001||0.51|TWO_SIDED|95.0|-0.004|0.002|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||0.002|-0.004|0.51
71061583|NCT02717507|141631312|OTHER||Slope|-0.022|STANDARD_ERROR_OF_MEAN|0.228||0.92|TWO_SIDED|95.0|-0.468|0.424|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||0.424|-0.468|0.92
71061584|NCT02717507|141631314|OTHER||Slope|0.024|STANDARD_ERROR_OF_MEAN|0.104||0.82|TWO_SIDED|95.0|-0.18|0.229|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment can be considered beneficial if the mean difference (treatment - control) slope is negative.|||0.229|-0.18|0.82
71061585|NCT02717507|141631315|OTHER||Slope|-0.096|STANDARD_ERROR_OF_MEAN|2.439||0.97|TWO_SIDED|95.0|-4.877|4.685|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||4.685|-4.877|0.97
71061586|NCT02717507|141631316|OTHER||Slope|1.248|STANDARD_ERROR_OF_MEAN|3.491||0.72|TWO_SIDED|95.0|-5.595|8.091|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment can be considered beneficial if the mean difference (treatment - control) slope is negative.|The null hypothesis is that change in Average Alanine aminotransferase across time-points described above does not differ by treatment arm, tested using a longitudinal GEE analysis of Average Alanine aminotransferase with a treatment by time interaction.||8.091|-5.595|0.72
70936807|NCT00824850|141373426|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.6|||||TWO_SIDED|95.0|0.32|1.12|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 19F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.12|0.32|
70936808|NCT00824850|141373426|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.6|||||TWO_SIDED|95.0|0.38|0.85|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 23F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||0.85|0.38|
71061587|NCT00742209|141631323|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|0.3||||0.579|TWO_SIDED|95.0|-0.6|1.1||A combination of a sequential method and the Hochberg procedure has been used to maintain the overall experiment-size alphas level of 0.05 for the comparison of GEn vs. placebo.|ANCOVA|An ANCOVA model with baseline number of MHD and IHS Headache Classification for presence or absence of aura as covariates was used.|Adjusted mean difference versus placebo|||1.1|-0.6|0.579
71061588|NCT02562066|141631342|OTHER||Mean Difference (Net)|1.63||||0.085|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Results show the difference in mean CFB at the end of Study Period 1.|A Mann-Whitney-Wilcoxon test for equality of the change from baseline (CFB) in the two treatments in Period 1 will be presented.||||0.085
71061589|NCT02562066|141631342|OTHER||Mean Difference (Net)|0.56|||||TWO_SIDED|95.0|-0.97|2.09|||Mixed Models Analysis||Results show the LSMeans for the estimated difference between treatments in Period 1 along with a 95% confidence interval for this difference.|A mixed effects linear model will be fit to the data with SGI raw scores as the response and fixed effect terms for treatment, period, age group, mutation type and sequence\*period, and a random effect for patient. The LSMeans for the estimated difference between treatments in Period 1 along with a 95% confidence interval for this difference.||2.09|-0.97|
71061590|NCT02562066|141631343|OTHER||Mean Difference (Net)|3.17||||0.376|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Results show the difference in mean CFB at the end of Study Period 1.|A Mann-Whitney-Wilcoxon test for equality of the change from baseline (CFB) in the two treatments in Period 1 will be presented.||||0.376
71061591|NCT02562066|141631343|OTHER||Mean Difference (Net)|1.14|||||TWO_SIDED|95.0|-2.31|4.58|||Mixed Models Analysis||Results show the LSMeans for the estimated difference between treatments in Period 1 along with a 95% confidence interval for this difference.|A mixed effects linear model will be fit to the data with Overall MFM-32 scores as the response and fixed effect terms for treatment, period, age group, mutation type and sequence\*period, and a random effect for patient. The LSMeans for the estimated difference between treatments in Period 1 along with a 95% confidence interval for this difference.||4.58|-2.31|
71061592|NCT02562066|141631344|OTHER||Mean Difference (Net)|-1.0||||0.8|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Results show the difference in mean CFB at the end of Study Period 1.|A Mann-Whitney-Wilcoxon test for equality of the change from baseline (CFB) in the two treatments in Period 1 will be presented.||||0.800
71061593|NCT02562066|141631344|OTHER||Mean Difference (Net)|0.63|||||TWO_SIDED|95.0|-5.25|6.5|||Mixed Models Analysis||Results show the LSMeans for the estimated difference between treatments in Period 1 along with a 95% confidence interval for this difference.|A mixed effects linear model will be fit to the data with Overall MFM-20 scores as the response and fixed effect terms for treatment, period, age group, mutation type and sequence\*period, and a random effect for patient. The LSMeans for the estimated difference between treatments in Period 1 along with a 95% confidence interval for this difference.||6.50|-5.25|
71061594|NCT03500198|141631376|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||< 0.0001
71061595|NCT03500198|141631378|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
71061596|NCT03500198|141631379|SUPERIORITY||||||<|0.0001|||||||1-sided logistic regression|||||||<0.0001
71061597|NCT01998919|141631415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.34|||||TWO_SIDED|95.0|-10.3|17.0|||||Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||17.0|-10.3|
71061598|NCT01998919|141631416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.63|||||TWO_SIDED|95.0|-5.6|26.8|||||Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||26.8|-5.6|
71061599|NCT01998919|141631417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.48|||||TWO_SIDED|95.0|-2.7|27.7|||||Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||27.7|-2.7|
71061600|NCT01998919|141631418|SUPERIORITY_OR_OTHER|||||||0.0075|||||||Log Rank|||||||0.0075
71061601|NCT01998919|141631418|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.42||||0.0099|TWO_SIDED|95.0|0.22|0.81|||Wald test|||||0.81|0.22|0.0099
70941734|NCT04748445|141383935|OTHER||Slope|0.00006573|STANDARD_ERROR_OF_MEAN|2.81||0.8154|TWO_SIDED|90.0|-0.0003998|0.0005313|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0005313|-0.0003998|0.8154
71061602|NCT01998919|141631419|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Log Rank|||||||0.0004
71061603|NCT01998919|141631419|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.48||||0.0001|TWO_SIDED|95.0|0.33|0.7|||Wald Test|||||0.70|0.33|0.0001
71061604|NCT01998919|141631420|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Log Rank|||||||0.0001
71061605|NCT01998919|141631420|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.33|0.68|||Wald test|||||0.68|0.33|<0.0001
71061606|NCT01998919|141631421|SUPERIORITY_OR_OTHER|||||||0.5991|||||||Log Rank|||||||0.5991
71061607|NCT01998919|141631421|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.3774|TWO_SIDED|95.0|0.58|1.23|||Wald test|||||1.23|0.58|0.3774
71061608|NCT01400477|141631506|SUPERIORITY|||||||0.89||||||A priori vape was \<0.05|ANOVA|df 1, 37||||||0.89
71061609|NCT01532934|141631520|SUPERIORITY_OR_OTHER|||||||0.02||||||As stated, the p-value reflects the Factor 1 by treatment interaction term and its effect on percent days abstinent/month.|Regression, Linear|||A priori hypothesis. Psychopathy Factor 1 (F1) X treatment interaction to predict higher substance use among people high in F1 + who get treatment relative to individuals with high F1 who get standard care.||||.02
71061610|NCT01532934|141631521|SUPERIORITY_OR_OTHER|||||||0.34||||||As stated, the p-value reflects the F1 X treatment interaction term and its effect on substance use consequences. A priori threshold for significance was p\<.05.|Regression, Linear|||Experimental hypothesis: The F1 X treatment interaction will show that individuals low on F1 who get treatment will reduce substance use consequences at six months relative to those low on F1 who get standard care.||||.34
71061611|NCT01532934|141631522|SUPERIORITY_OR_OTHER|||||||0.69||||||a priori threshold p\<.05|Regression, Logistic|||Experimental hypothesis: Treatment X F1 interaction will predict fewer charges at one-year follow-up for individuals low on F1 who got treatment relative to individuals low on F1 who did not.||||.69
71061612|NCT02291237|141631526|SUPERIORITY||LS Mean Difference(Eleclazine - Placebo)|-0.55||||0.416|TWO_SIDED|95.0|-1.87|0.78|||ANCOVA|P-value and Least Squares (LS) Means are from model with terms for sex, age (continuous), and treatment group and baseline peak VO2 as the covariate.||The analysis evaluated the change in Peak VO2 from baseline to Week 24 for the eleclazine group compared with that of the placebo group using analysis of covariance (ANCOVA) including terms for baseline Peak VO2, sex, and age (continuous).||0.78|-1.87|0.416
71061613|NCT02291237|141631527|SUPERIORITY||LS Mean Difference(Eleclazine - Placebo)|-0.42||||0.517|TWO_SIDED|95.0|-1.68|0.85||P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline peak VO2 as the covariate.|ANCOVA|||The analysis evaluated the change in Peak VO2 from baseline to Week 12 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline Peak VO2, sex, and age (continuous).||0.85|-1.68|0.517
71061614|NCT02291237|141631528|SUPERIORITY||LS Mean Difference(Eleclazine - Placebo)|1.54||||0.513|TWO_SIDED|95.0|-3.11|6.19|||ANCOVA|P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline score as the covariate.||The analysis evaluated the change in MLHFQ from baseline to Week 24 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline treadmill exercise time, sex, and age (continuous).||6.19|-3.11|0.513
71061615|NCT02291237|141631529|SUPERIORITY||LS Mean Difference(Eleclazine - Placebo)|0.1||||0.964|TWO_SIDED|95.0|-4.36|4.56|||ANCOVA|P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline score as the covariate.||The analysis evaluated the change in MLHFQ from baseline to Week 12 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline treadmill exercise time, sex, and age (continuous).||4.56|-4.36|0.964
71061616|NCT02291237|141631530|SUPERIORITY||LS Mean Difference(Eleclazine - Placebo)|-0.04||||0.944|TWO_SIDED|95.0|-1.18|1.1|||ANCOVA|P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline score as the covariate.||The analysis evaluated the change in treadmill exercise time from baseline to Week 24 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline treadmill exercise time, sex, and age (continuous).||1.10|-1.18|0.944
71061617|NCT02291237|141631531|SUPERIORITY||LS Mean Difference(Eleclazine - Placebo)|0.0||||0.993|TWO_SIDED|95.0|-0.96|0.97|||ANCOVA|P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline score as the covariate.||The analysis evaluated the change in treadmill exercise time from baseline to Week 12 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline treadmill exercise time, sex, and age (continuous).||0.97|-0.96|0.993
71061618|NCT00699998|141631562|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.915||||0.21|TWO_SIDED|95.0|0.793|1.055||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.055|0.793|0.210
71061619|NCT00699998|141631562|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.029||||0.731|TWO_SIDED|95.0|0.865|1.225||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.225|0.865|0.731
71061620|NCT00699998|141631563|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.388|TWO_SIDED|95.0|0.812|1.088|||Log Rank|Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.088|0.812|0.388
71061621|NCT00699998|141631563|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.998||||0.99|TWO_SIDED|95.0|0.833|1.195||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.195|0.833|0.990
71061622|NCT00699998|141631564|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.941||||0.353|TWO_SIDED|95.0|0.826|1.073||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.073|0.826|0.353
71061623|NCT00699998|141631564|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.029||||0.719|TWO_SIDED|95.0|0.869|1.218||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.218|0.869|0.719
71061624|NCT00699998|141631565|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.928||||0.27|TWO_SIDED|95.0|0.81|1.063||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.063|0.810|0.270
71061625|NCT00699998|141631565|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.017||||0.831|TWO_SIDED|95.0|0.862|1.2||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.200|0.862|0.831
71061626|NCT00699998|141631566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-100.208|||<|0.001|TWO_SIDED|95.0|-107.872|-92.545||p-value is for Day 30 comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Estimated Mean Difference (Final Values) for Day 30 comparison|||-92.545|-107.872|<0.001
71061627|NCT00699998|141631566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-104.475|||<|0.001|TWO_SIDED|95.0|-115.383|-93.566||p-value is for 12 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Estimated Mean Difference (Final Values) for 12 month comparison.|||-93.566|-115.383|<0.001
71061628|NCT00699998|141631566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-48.413|||<|0.001|TWO_SIDED|95.0|-63.718|-33.108||p-value is for 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Estimated Mean Difference (Final Values) is for the 30 day comparison.|||-33.108|-63.718|<0.001
71061629|NCT00699998|141631566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.264|||<|0.001|TWO_SIDED|95.0|-69.061|-23.468||p-value is for the 12 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Estimated Mean Difference (Final Values) is for the 12 month comparison.|||-23.468|-69.061|<0.001
71061630|NCT00699998|141631567|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|0.982||||0.631|TWO_SIDED|95.0|0.91|1.059||p-value is for the 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 30 day comparison.|||1.059|0.910|0.631
71061631|NCT00699998|141631567|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.01||||0.844|TWO_SIDED|95.0|0.916|1.113||p-value is for the 6 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 6 month comparison.|||1.113|0.916|0.844
71061632|NCT00699998|141631567|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.138||||0.098|TWO_SIDED|95.0|0.977|1.325||p-value is for the 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 30 day comparison.|||1.325|0.977|0.098
71061633|NCT00699998|141631567|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.066||||0.545|TWO_SIDED|95.0|0.867|1.31||p-value is for the 6 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 6 month comparison.|||1.310|0.867|0.545
71061634|NCT00699998|141631568|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.018||||0.727|TWO_SIDED|95.0|0.919|1.129||p-value is for the 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 30 day comparison.|||1.129|0.919|0.727
71061635|NCT00699998|141631568|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.057||||0.346|TWO_SIDED|95.0|0.942|1.187||p-value is for the 6 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 6 month comparison.|||1.187|0.942|0.346
71061636|NCT00699998|141631568|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.096||||0.458|TWO_SIDED|95.0|0.859|1.399||p-value is for the 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 30 day comparison.|||1.399|0.859|0.458
71061637|NCT00699998|141631568|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.033||||0.802|TWO_SIDED|95.0|0.803|1.329||p-value is for the 6 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 6 month comparison.|||1.329|0.803|0.802
71061638|NCT00699998|141631570|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||p-value is for the comparison of physical limitations at baseline. p-values are from a regression model with treatment group and the respective baseline quality-of-life measure as predictors.|ANCOVA|||||||0.5
71061639|NCT00699998|141631570|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||p-value is for the comparison of angina frequency at baseline. p-values are from a regression model with treatment group and the respective baseline quality-of-life measure as predictors.|ANCOVA|||||||0.72
71061640|NCT00699998|141631570|SUPERIORITY_OR_OTHER|||||||0.63||95.0||||p-value is for the comparison of physical limitations at 24 months. p-values are from a regression model with treatment group and the respective baseline quality-of-life measure as predictors.|ANCOVA|||||||0.63
71061641|NCT00699998|141631570|SUPERIORITY_OR_OTHER|||||||0.53||95.0||||p-value is for the comparison of angina frequency at at 24 months. p-values are from a regression model with treatment group and the respective baseline quality-of-life measure as predictors.|ANCOVA|||||||0.53
71061642|NCT02892331|141631578|SUPERIORITY|||||||0.006||||||VO2 testing was not performed for one participant in the HIGH-INT group.|ANCOVA|||Comparison between the CON and the HIGH-INT group||||0.006
71061643|NCT02892331|141631578|SUPERIORITY|||||||0.045||||||VO2 testing was not performed for one participant in the HIGH-INT group.|ANCOVA|||Comparison between the CON and MOD-INT group||||0.045
71061644|NCT02892331|141631578|SUPERIORITY|VO2 testing was not performed for one participant in the HIGH-INT group.||||||0.449|||||||ANCOVA|||Comparison between MOD-INT and High-INT groups||||0.449
71061645|NCT02892331|141631579|SUPERIORITY|||||||0.276|||||||ANCOVA|||Comparison between the CON and High-INT groups||||0.276
71061646|NCT02892331|141631579|SUPERIORITY|||||||0.633|||||||ANCOVA|||Comparison between the CON and MOD-INT groups||||0.633
71061647|NCT02892331|141631579|SUPERIORITY|||||||0.555|||||||ANCOVA|||Comparison between the MOD-INT and HIGH-INT groups||||0.555
71061648|NCT02892331|141631580|SUPERIORITY|||||||0.37|||||||ANCOVA|||Comparison between the CON group and the HIGH-INT group||||0.370
71061649|NCT02892331|141631580|SUPERIORITY|||||||0.383|||||||ANCOVA|||Comparison between the CON and the MOD-INT group||||0.383
71061650|NCT02892331|141631580|SUPERIORITY|||||||0.0972|||||||ANCOVA|||Comparison for the MOD-INT and HIGH-INT groups||||0.0972
71061651|NCT02892331|141631581|SUPERIORITY|||||||0.932|||||||ANCOVA|||Comparison between the CON and the HIGH-INT groups||||0.932
71061652|NCT02892331|141631581|SUPERIORITY|||||||0.307|||||||ANCOVA|||Comparison between the CON and MOD-INT groups||||0.307
71061653|NCT02892331|141631581|SUPERIORITY|||||||0.376|||||||ANCOVA|||Comparison between the MOD-INT and the HIGH-INT groups||||0.376
71061654|NCT02892331|141631582|SUPERIORITY|||||||0.136|||||||ANCOVA|||Comparison between the CON and the HIGH-INT groups||||0.136
71061655|NCT02892331|141631582|SUPERIORITY|||||||0.262|||||||ANCOVA|||Comparison between the CON and the MOD-INT group||||0.262
71061656|NCT02892331|141631582|SUPERIORITY|||||||0.715|||||||ANCOVA|||Comparison between the MOD-INT group and the HIGH-INT groups||||0.715
70936809|NCT00824850|141373426|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.3|||||TWO_SIDED|95.0|0.75|2.22|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 1: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.22|0.75|
70936810|NCT00824850|141373426|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.1|||||TWO_SIDED|95.0|0.82|1.61|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 3: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.61|0.82|
70936811|NCT00824850|141373426|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.36|2.13|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 5: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.13|0.36|
70936812|NCT00824850|141373426|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.55|1.39|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 6A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.39|0.55|
71061657|NCT02892331|141631583|SUPERIORITY|||||||0.056|||||||ANCOVA|||Comparison between the CON and High-INT groups||||0.056
71061658|NCT02892331|141631583|SUPERIORITY|||||||0.349|||||||ANCOVA|||Comparison between the CON and MOD-INT groups||||0.349
70936813|NCT00824850|141373426|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.1|||||TWO_SIDED|95.0|0.73|1.7|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 7F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.70|0.73|
70936814|NCT00824850|141373426|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.5|1.63|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 19A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.63|0.50|
70936815|NCT00824850|141373427|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.7|||||TWO_SIDED|95.0|0.35|1.27|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 4: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.27|0.35|
70936816|NCT00824850|141373427|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.3|||||TWO_SIDED|95.0|0.77|2.05|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 6B: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.05|0.77|
71061659|NCT02892331|141631583|SUPERIORITY|||||||0.359|||||||ANCOVA|||Comparison between the MOD-INT and HIGH-INT groups||||0.359
71061660|NCT02892331|141631584|SUPERIORITY|||||||0.224|||||||ANCOVA|||Comparison between the CON and HIGH-INT groups||||0.224
70941735|NCT04748445|141383935|OTHER||Slope|-0.0004071|STANDARD_ERROR_OF_MEAN|3.664||0.2687|TWO_SIDED|90.0|-0.001014|0.0002001|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0002001|-0.001014|0.2687
71061661|NCT02892331|141631584|SUPERIORITY|||||||0.199|||||||ANCOVA|||Comparison between the CON and MOD-INT groups||||0.199
71061662|NCT02892331|141631584|SUPERIORITY|||||||0.952|||||||ANCOVA|||Comparison between the MOD-INT and the HIGH-INT groups||||0.952
71061663|NCT02892331|141631585|SUPERIORITY|||||||0.783|||||||ANCOVA|||Comparison between the CON and HIGH-INT groups||||0.783
71061664|NCT02892331|141631585|SUPERIORITY|||||||0.098|||||||ANCOVA|||Comparison between the CON and MOD-INT groups||||0.098
71061665|NCT02892331|141631585|SUPERIORITY|||||||0.071|||||||ANCOVA|||Comparison between the MOD and HIGH-INT groups||||0.071
71061666|NCT02892331|141631586|SUPERIORITY|||||||0.94|||||||ANCOVA|||Comparison between the CON and the HIGH-INT groups||||0.940
71061667|NCT02892331|141631586|SUPERIORITY|||||||0.994|||||||ANCOVA|||Comparison between the CON and MOD-INT groups||||0.994
71061668|NCT02892331|141631586|SUPERIORITY|||||||0.94|||||||ANCOVA|||Comparison between the MOD-INT and HIGH-INT groups||||0.940
71061669|NCT02892331|141631587|SUPERIORITY|||||||0.769|||||||ANCOVA|||Comparison of the CON and HIGH-INT groups||||0.769
71061670|NCT02892331|141631587|SUPERIORITY|||||||0.8|||||||ANCOVA|||Comparison of the CON and MOD-INT groups||||0.800
71061671|NCT02892331|141631587|SUPERIORITY|||||||0.769|||||||ANCOVA|||||||0.769
71061672|NCT02892331|141631588|SUPERIORITY|||||||1|||||||ANCOVA|||Comparison between the CON and the MOD groups||||1.000
71061673|NCT02892331|141631588|SUPERIORITY|||||||0.993|||||||ANCOVA|||Comparison of HIGH-INT and CON groups||||0.993
71061674|NCT02892331|141631588|SUPERIORITY|||||||0.994|||||||ANCOVA|||Comparison between the MOD-INT and the HIGH-INT groups||||0.994
71061675|NCT02892331|141631589|SUPERIORITY|||||||0.821|||||||ANCOVA|||Change in insulin sensitivity (CON vs. HIGH-INT)||||0.821
71061676|NCT02892331|141631589|SUPERIORITY|||||||0.985|||||||ANCOVA|||Change in insulin sensitivity (CON vs. MOD-INT)||||0.985
71061677|NCT02892331|141631589|SUPERIORITY|||||||0.856|||||||ANCOVA|||Change in insulin sensitivity (MOD-INT vs. HIGH-INT)||||0.856
71061678|NCT02892331|141631590|SUPERIORITY|||||||0.093|||||||ANCOVA|||Comparison between the CON and HIGH-INT groups||||0.093
71061679|NCT02892331|141631590|SUPERIORITY|||||||0.033|||||||ANCOVA|||Comparison between the CON and the MOD-INT groups||||0.033
71061680|NCT02892331|141631590|SUPERIORITY|||||||0.602|||||||ANCOVA|||Comparison between the MOD-INT and HIGH-INT groups||||0.602
71061681|NCT02892331|141631591|SUPERIORITY|||||||0.424|||||||ANCOVA|||Change in PGC1A (CON vs. HIGH-INT)||||0.424
71061682|NCT02892331|141631591|SUPERIORITY|||||||0.308|||||||ANCOVA|||Change in PGC1A (CON vs. MOD-INT)||||0.308
71061683|NCT02892331|141631591|SUPERIORITY|||||||0.844|||||||ANCOVA|||Change in PGC1a (MOD-INT vs. HIGH-INT)||||0.844
71061684|NCT02892331|141631591|SUPERIORITY|||||||0.135|||||||ANCOVA|||Change in citrate synthase (CON vs. HIGH-INT)||||0.135
71061685|NCT02892331|141631591|SUPERIORITY|||||||0.8|||||||ANCOVA|||Change in Citrate synthase (CON vs. MOD-INT)||||0.800
71061686|NCT02892331|141631591|SUPERIORITY|||||||0.195|||||||ANCOVA|||Change in citrate synthase||||0.195
71110203|NCT01925768|141725977|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|11.0||||0.0884|TWO_SIDED|95.0|-1.3|23.2||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 12; 2-sided 95% CI is based on a normal approximation to the weighted average||23.2|-1.3|0.0884
71110204|NCT01925768|141725977|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|18.6||||0.004|TWO_SIDED|95.0|6.5|30.7||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 20; 2-sided 95% CI is based on a normal approximation to the weighted average||30.7|6.5|0.0040
71110205|NCT00251693|141725994|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 95% CI was greater than -10%, noninferiority was concluded. Superiority of primary efficacy endpoint was assessed by comparing the crude healing rate of dexlansoprazole MR 60 mg dose to that of lansoprazole 30 mg using a Cochran Mantel Haenszel (CMH) test with baseline LA EE Grade as strata.|Difference in percentage|6.33||||0.004||95.0|2.17|10.48||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Cochran-Mantel-Haenszel|||||10.48|2.17|0.004
71110206|NCT00251693|141725994|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 95% CI was greater than -10%, noninferiority was concluded. Superiority of primary efficacy endpoint was assessed by comparing the crude healing rate of dexlansoprazole MR 90 mg dose to that of lansoprazole 30 mg using a Cochran Mantel Haenszel (CMH) test with baseline LA EE Grade as strata.|Difference in percentage|6.84||||0.001||95.0|2.7|10.98||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Cochran-Mantel-Haenszel|||||10.98|2.70|0.001
70936817|NCT00824850|141373427|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.54|1.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 9V: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.44|0.54|
70936818|NCT00824850|141373427|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.6|||||TWO_SIDED|95.0|0.38|0.95|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 14: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||0.95|0.38|
71061687|NCT02892331|141631591|SUPERIORITY|||||||0.459|||||||ANCOVA|||Change in complex I||||0.459
71061688|NCT02892331|141631591|SUPERIORITY|||||||0.213|||||||ANCOVA|||Change in complex 1 (CON vs. MOD-INT groups)||||0.213
71061689|NCT02892331|141631591|SUPERIORITY|||||||0.971|||||||ANCOVA|||Change in complex II (MOD-INT vs. HIGH-INT)||||0.971
71061690|NCT02892331|141631591|SUPERIORITY|||||||0.634|||||||ANCOVA|||Change in complex III (CON vs. HIGH-INT)||||0.634
71110207|NCT00251693|141725994|SUPERIORITY_OR_OTHER|||||||0.727||95.0||||Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.727
71110208|NCT00251693|141725995|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.002
71061691|NCT02892331|141631591|SUPERIORITY|||||||0.919|||||||ANCOVA|||Change in Complex III (CON vs. MOD-INT groups)||||0.919
71061692|NCT02892331|141631591|SUPERIORITY|||||||0.574|||||||ANCOVA|||Change in complex III||||0.574
71061693|NCT02892331|141631591|SUPERIORITY|||||||0.295|||||||ANCOVA|||Change in Complex IV (CON vs. HIGH-INT)||||0.295
71061694|NCT02892331|141631591|SUPERIORITY|||||||0.097|||||||ANCOVA|||Change in complex IV (CON vs. MOD-INT)||||0.097
71061695|NCT02892331|141631591|SUPERIORITY|||||||0.468|||||||ANCOVA|||Change in complex IV||||0.468
71061696|NCT02892331|141631591|SUPERIORITY|||||||0.589|||||||ANCOVA|||Change in complex V||||0.589
71061697|NCT02892331|141631591|SUPERIORITY|||||||0.196|||||||ANCOVA|||Change in complex V (CON vs. MOD-INT)||||0.196
71061698|NCT02892331|141631591|SUPERIORITY|||||||0.436|||||||ANCOVA|||Change in Complex V (MOD-INT vs. HIGH-INT)||||0.436
71061699|NCT02892331|141631592|SUPERIORITY|||||||0.756|||||||ANCOVA|||Comparison of general health subscale (CON vs. HIGH INT)||||0.756
71061700|NCT02892331|141631592|SUPERIORITY|||||||0.115|||||||ANCOVA|||General Health Subscale (CON vs. MOD-INT)||||0.115
71110209|NCT00251693|141725995|SUPERIORITY_OR_OTHER|||||||0.045||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.045
71110210|NCT00251693|141725995|SUPERIORITY_OR_OTHER|||||||0.245||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.245
71110211|NCT00251693|141725996|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.011
71110212|NCT00251693|141725996|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.017
71110213|NCT00251693|141725996|SUPERIORITY_OR_OTHER|||||||0.927||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Log Rank|||||||0.927
70936819|NCT00824850|141373427|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.1|||||TWO_SIDED|95.0|0.64|1.91|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 18C: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.91|0.64|
70936820|NCT00824850|141373427|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.7|||||TWO_SIDED|95.0|0.28|1.62|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 19F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.62|0.28|
70936821|NCT00824850|141373427|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.4|||||TWO_SIDED|95.0|0.68|2.81|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 23F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.81|0.68|
70936822|NCT00824850|141373427|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.0|||||TWO_SIDED|95.0|0.53|1.77|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 1: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.77|0.53|
70936823|NCT00824850|141373427|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.1|||||TWO_SIDED|95.0|0.69|1.81|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 3: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.81|0.69|
70936824|NCT00824850|141373427|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.8|||||TWO_SIDED|95.0|0.32|1.85|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 5: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.85|0.32|
70936825|NCT00824850|141373427|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.4|||||TWO_SIDED|95.0|0.8|2.36|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 6A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.36|0.80|
70936826|NCT00824850|141373427|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.3|||||TWO_SIDED|95.0|0.65|2.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 7F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.44|0.65|
71061701|NCT02892331|141631592|SUPERIORITY|||||||0.225|||||||ANCOVA|||General Health Subscale (MOD-INT vs. HIGH-INT)||||0.225
71061702|NCT02892331|141631592|SUPERIORITY|||||||0.758|||||||ANCOVA|||Physical health Sub-scale (CON vs. HIGH-INT)||||0.758
70936827|NCT00824850|141373427|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.46|1.57|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 19A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.57|0.46|
70936828|NCT00824850|141373430|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.2|10.9||||||7vPnC serotype 4: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.9|-10.2|
71061703|NCT02892331|141631592|SUPERIORITY|||||||0.759|||||||ANCOVA|||Physical health subscale (CON vs. MOD-INT)||||0.759
70936829|NCT00824850|141373430|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
70936830|NCT00824850|141373430|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
70936831|NCT00824850|141373430|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
70936832|NCT00824850|141373430|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
70936833|NCT00824850|141373430|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
71061704|NCT02892331|141631592|SUPERIORITY|||||||0.465|||||||ANCOVA|||Physical Health subscale (MOD-INT vs. HIGH-INT)||||0.465
70936834|NCT00824850|141373430|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
71061705|NCT02892331|141631592|SUPERIORITY|||||||0.549|||||||ANCOVA|||Role Physical subscale (CON vs. HIGH-INT)||||0.549
71061706|NCT02892331|141631592|SUPERIORITY|||||||0.679|||||||ANCOVA|||Role Physical Subscale (CON vs. MOD-INT)||||0.679
71061707|NCT02892331|141631592|SUPERIORITY|||||||0.334|||||||ANCOVA|||Role Physical Subscale (MOD-INT vs. HIGH-INT)||||0.334
71061708|NCT02892331|141631592|SUPERIORITY|||||||0.273|||||||ANCOVA|||Bodily pain subscale (CON vs. HIGH-INT)||||0.273
71061709|NCT02892331|141631592|SUPERIORITY|||||||0.642|||||||ANCOVA|||Bodily pain subscale (CON vs. MOD-INT)||||0.642
71061710|NCT02892331|141631592|SUPERIORITY|||||||0.52|||||||ANCOVA|||Bodily Pain Subscale (MOD-INT vs. HIGH-INT)||||0.520
71061711|NCT02892331|141631592|SUPERIORITY|||||||0.46|||||||ANCOVA|||Vitality subscale (CON vs. HIGH-INT)||||0.460
71061712|NCT02892331|141631592|SUPERIORITY|||||||0.203|||||||ANCOVA|||Vitality sub-scale (CON vs. MOD-INT group)||||0.203
71061713|NCT02892331|141631592|SUPERIORITY|||||||0.058|||||||ANCOVA|||Vitality subscale (MOD-INT vs. HIGH-INT)||||0.058
71061714|NCT02892331|141631592|SUPERIORITY|||||||0.739|||||||ANCOVA|||Social Function subscale (CON vs. HIGH-INT)||||0.739
71061715|NCT02892331|141631592|SUPERIORITY|||||||0.059|||||||ANCOVA|||Social Function subscale (CON vs. MOD-INT)||||0.059
71061716|NCT02892331|141631592|SUPERIORITY|||||||0.038|||||||ANCOVA|||Social Function sub-scale (HIGH-INT vs. MOD-INT)||||0.0380
71061717|NCT02892331|141631592|SUPERIORITY|||||||0.95|||||||ANCOVA|||Comparison of mental health subscale (CON vs. HIGH-INT)||||0.950
71061718|NCT02892331|141631592|SUPERIORITY|||||||0.096|||||||ANCOVA|||Change in mental health subscale (CON Vs. MOD INT)||||0.096
71061719|NCT02892331|141631592|SUPERIORITY|||||||0.127|||||||ANCOVA|||Change in mental health subscale (MOD-INT vs. HIGH-INT)||||0.127
71061720|NCT02892331|141631592|SUPERIORITY|||||||0.373|||||||ANCOVA|||Change in role emotional subscale (CON vs HIGH-INT)||||0.373
71061721|NCT02892331|141631592|SUPERIORITY|||||||0.63|||||||ANCOVA|||Change in role emotional sub-scale||||0.630
71061722|NCT02892331|141631592|SUPERIORITY|||||||0.034|||||||ANCOVA|||Change in role emotional subscale (MOD vs. HIGH-INT)||||0.034
71061723|NCT02892331|141631592|SUPERIORITY|||||||0.07|||||||ANCOVA|||Change in role emotional subscale (CON vs. MOD-INT)||||0.070
71061724|NCT02892331|141631592|SUPERIORITY|||||||0.945|||||||ANCOVA|||Change in physical health sub-scale (MOD-INT vs. HIGH-INT)||||0.945
71061725|NCT02892331|141631593|SUPERIORITY|||||||0.65|||||||ANCOVA|||Change in the mental health sum scale (CON vs. HIGH-INT)||||0.650
71061726|NCT02892331|141631593|SUPERIORITY|||||||0.034|||||||ANCOVA|||Change in mental health (sum) subscale (MOD-INT vs. HIGH-INT)||||0.034
71061727|NCT02892331|141631593|SUPERIORITY|||||||0.33|||||||ANCOVA|||Change in physical health (sum)||||0.330
71061728|NCT02892331|141631593|SUPERIORITY|||||||0.297|||||||ANCOVA|||Change in physical health (sum) subscale||||0.297
71061729|NCT02892331|141631594|SUPERIORITY|||||||0.109|||||||ANCOVA|||Change in steps (CON vs. HIGH-INT)||||0.109
71061730|NCT02892331|141631594|SUPERIORITY|||||||0.099|||||||ANCOVA|||Change in steps (CON vs. MOD-INT)||||0.099
71061731|NCT02892331|141631594|SUPERIORITY|||||||0.947|||||||ANCOVA|||Change in steps (MOD-INT vs. HIGH-INT)||||0.947
71061732|NCT00610428|141631597|SUPERIORITY|||||||0.084||||||p-values calculated by Log-rank Test in step-down sequence (10 mg to 5 mg)|Survival|||Survival time is defined as time to the first successful headache relief.||||0.0840
71061733|NCT00610428|141631597|SUPERIORITY|Survival time is defined as time to the first successful headache relief.||||||0.0383||||||p-values calculated by Log-rank Test in step-down sequence (10 mg to 5 mg)|Survival|||||||0.0383
71061734|NCT02490631|141631617|SUPERIORITY|||||||0.456|||||||Chi-squared|||||||0.456
71061735|NCT02490631|141631618|SUPERIORITY|||||||0.019|||||||Chi-squared|||||||.019
71061736|NCT02546986|141631619|SUPERIORITY||Hazard Ratio (HR)|1.374||||0.1789|TWO_SIDED|90.0|0.926|2.038|||Stratified Log-Rank Test|Stratified by squamous cell carcinoma versus non-squamous cell carcinoma|Hazard ratio and associated 2-sided 90% CIs were estimated using a Cox proportional hazard model|||2.038|0.926|0.1789
71061737|NCT02546986|141631620|SUPERIORITY||Disease Control Rate Difference|-13.3||||0.1572|TWO_SIDED|90.0|-29.0|3.5|||Cochran-Mantel-Haenszel|Stratified by squamous cell carcinoma vs non-squamous cell carcinoma||||3.5|-29.0|0.1572
71061738|NCT02546986|141631621|SUPERIORITY||Hazard Ratio (HR)|1.375||||0.2968|TWO_SIDED|90.0|0.83|2.276|||Stratified Log Rank|Stratified by squamous cell carcinoma vs non-squamous cell carcinoma).|Hazard ratio and associated 2-sided 90% CIs were estimated using Cox proportional hazard model.|||2.276|0.830|0.2968
71061739|NCT02546986|141631622|SUPERIORITY||Overall Response Rate (ORR) Difference|5.3|||||TWO_SIDED|90.0|-11.5|21.3|||||The 90% exact unconditional confidence interval was used for ORR difference.|||21.3|-11.5|
71061740|NCT02546986|141631624|SUPERIORITY||Hazard Ratio (HR)|1.352||||0.199|TWO_SIDED|90.0|0.914|2.0|||Stratified Log-Rank Test|Stratified by squamous cell carcinoma versus non-squamous cell carcinoma|Hazard ratio and associated 2-sided 90% CIs were estimated using a Cox proportional hazard model|||2.000|0.914|0.1990
71061741|NCT05258773|141631646|SUPERIORITY||LS Mean difference Arm A - Arm B|-11.0||||0.1406|TWO_SIDED|95.0|-25.9|3.9||An analysis of covariance (ANCOVA) model was used to assess changes from baseline at 500Hz at the Day 49 visit comparing the treatment groups.The treatment group was included as a fixed factor, with baseline values as a covariate.|ANCOVA||The change in hearing threshold from baseline was expected to be smaller in the treated group (arm A) than in the control group (arm B).|||3.9|-25.9|0.1406
71061742|NCT05258773|141631646|SUPERIORITY||LS Mean difference Arm A - Arm B|-14.4||||0.0567|TWO_SIDED|95.0|-29.24|0.45||An ANCOVA model was used to assess changes from baseline at the average across three frequencies (250-750 Hz) at the Day 49 visit comparing the treatment groups. The treatment group was included as a fixed factor, with baseline values as a covariate.|ANCOVA||The change in hearing threshold from baseline was expected to be smaller in the treated group (arm A) than in the control group (arm B).|||0.45|-29.24|0.0567
71061743|NCT05258773|141631646|SUPERIORITY||LS Mean difference Arm A - Arm B|-9.0||||0.2588|TWO_SIDED|95.0|-25.0|7.1||An ANCOVA model was used to assess changes from baseline at 500Hz at EOS on Day 105 comparing the treatment groups.The treatment group was included as a fixed factor, with baseline values as a covariate.|ANCOVA||The change in hearing threshold from baseline was expected to be smaller in the treated group (arm A) than in the control group (arm B).|||7.1|-25.0|0.2588
71061744|NCT05258773|141631646|SUPERIORITY||LS Mean difference Arm A - Arm B|-13.84||||0.0979|TWO_SIDED|95.0|-30.49|2.8||An ANCOVA model was used to assess changes from baseline at the average across three frequencies (250-750 Hz) at EOS on Day 105, comparing the treatment groups. The treatment group was included as a fixed factor, with baseline values as a covariate.|ANCOVA||The change in hearing threshold from baseline was expected to be smaller in the treated group (arm A) than in the control group (arm B).|||2.80|-30.49|0.0979
71061745|NCT05277922|141631648|SUPERIORITY||Geometric mean ratio|0.9999|||||TWO_SIDED|95.0|0.8313|1.2025||||||||1.2025|0.8313|
71061746|NCT05277922|141631648|SUPERIORITY||Geometric mean ratio|1.2454|||||TWO_SIDED|95.0|1.0355|1.4979||||||||1.4979|1.0355|
71061747|NCT05277922|141631648|SUPERIORITY||Geometric mean ratio|1.2392|||||TWO_SIDED|95.0|1.0304|1.4904||||||||1.4904|1.0304|
70936835|NCT00824850|141373430|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
71061748|NCT05277922|141631648|SUPERIORITY||Geometric mean ratio|1.2394|||||TWO_SIDED|95.0|1.0305|1.4906||||||||1.4906|1.0305|
71061749|NCT05277922|141631648|SUPERIORITY||Geometric mean ratio|0.995|||||TWO_SIDED|95.0|0.8273|1.1967||||||||1.1967|0.8273|
71061750|NCT05277922|141631648|SUPERIORITY||Geometric mean ratio|1.5058|||||TWO_SIDED|95.0|1.252|1.811||||||||1.8110|1.2520|
71061751|NCT05277922|141631648|SUPERIORITY||Geometric mean ratio|1.506|||||TWO_SIDED|95.0|1.2522|1.8113||||||||1.8113|1.2522|
71061752|NCT05277922|141631648|SUPERIORITY||Geometric mean ratio|1.2091|||||TWO_SIDED|95.0|1.0053|1.4541||||||||1.4541|1.0053|
71061753|NCT05277922|141631648|SUPERIORITY||Geometric mean ratio|1.2151|||||TWO_SIDED|95.0|1.0103|1.4614||||||||1.4614|1.0103|
71110214|NCT00251693|141725997|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was supported if the lower bound of the 95% CI for the difference with lansoprazole 30 mg of the estimated 8-week healing rate was greater than -10%. Superiority was assessed based on log-rank tests comparing treatments for the endpoints.|Difference in percentage|6.2||||0.06||95.0|2.3|10.11||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Log Rank|||||10.11|2.30|0.060
71061754|NCT05277922|141631648|SUPERIORITY||Geometric mean ratio|1.2456|||||TWO_SIDED|95.0|1.0357|1.4981||||||||1.4981|1.0357|
71061755|NCT03593473|141631668|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at -40 minutes.||||0.37
71061756|NCT03593473|141631668|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at -20 minutes.||||0.40
71061757|NCT03593473|141631668|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at 0 minutes.||||0.63
71061758|NCT03593473|141631668|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at 10 minutes.||||0.72
71061759|NCT03593473|141631668|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at 15 minutes.||||0.88
71061760|NCT03593473|141631668|SUPERIORITY|||||||0.85|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at 28 minutes.||||0.85
71061761|NCT03593473|141631668|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at 38 minutes.||||0.72
71061762|NCT03593473|141631668|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at 48 minutes.||||0.57
71061763|NCT03593473|141631668|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||A mixed effects model with random intercept and slope was used to model cortisol as the outcome variable with time, study arm, and an interaction between time and study arm as the exposure variables. Times are restricted to times 0, +10, +15, and +28, which reflect the measures taken during the Trier Social Stress Test. The p-value presented below is for the interaction term between time and study arm.||||0.96
71061764|NCT03593473|141631669|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at -40 minutes.||||0.71
71061765|NCT03593473|141631669|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at -20 minutes.||||0.92
71061766|NCT03593473|141631669|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at 0 minutes.||||0.92
71061767|NCT03593473|141631669|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at 10 minutes.||||0.40
71061768|NCT03593473|141631669|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at 15 minutes.||||0.97
71061769|NCT03593473|141631669|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at 28 minutes.||||0.71
71061770|NCT03593473|141631669|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at 38 minutes.||||0.78
71061771|NCT03593473|141631669|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at 48 minutes.||||0.63
71061772|NCT03593473|141631669|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||A mixed effects model with random intercept and slope was used to model cortisol as the outcome variable with time, study arm, and an interaction between time and study arm as the exposure variables. This is the p-value for the interaction term between time and study arm.||||0.11
71061773|NCT03593473|141631670|SUPERIORITY|||||||0.07|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at -40 minutes and Cortisol at -20 minutes.||||0.07
71061774|NCT03593473|141631670|SUPERIORITY|||||||0.22|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at -20 minutes and Cortisol at 0 minutes.||||0.22
71061775|NCT03593473|141631670|SUPERIORITY|||||||0.14|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at 0 minutes and Cortisol at +10 minutes.||||0.14
71061776|NCT03593473|141631670|SUPERIORITY|||||||0.14|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at +10 minutes and Cortisol at +15 minutes.||||0.14
71061777|NCT03593473|141631670|SUPERIORITY|||||||0.05|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at +15 minutes and Cortisol at +28 minutes.||||0.05
71061778|NCT03593473|141631670|SUPERIORITY|||||||0.1|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at +28 minutes and Cortisol at +38 minutes.||||0.10
71061779|NCT03593473|141631670|SUPERIORITY|||||||0.9|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at +38 minutes and Cortisol at +48 minutes.||||0.90
71061780|NCT03593473|141631670|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||A mixed effects model with random intercept and slope was used to model cortisol at time j+1 as the outcome with ACTH at time j, study arm, and an interaction term between ACTH at time j and study arm as the exposure variables. The p-value presented below is for the interaction term between ACTH at time j and study arm.||||0.21
71061781|NCT03593473|141631671|SUPERIORITY|||||||0.8441|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -40 to -35||||0.8441
71061782|NCT03593473|141631671|SUPERIORITY|||||||0.7919|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -35 to -30||||0.7919
70936836|NCT00824850|141373430|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
71061783|NCT03593473|141631671|SUPERIORITY|||||||0.5639|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -30 to -25||||0.5639
71061784|NCT03593473|141631671|SUPERIORITY|||||||0.3139|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -25 to -20||||0.3139
71061785|NCT03593473|141631671|SUPERIORITY|||||||0.4222|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -20 to -15||||0.4222
71061786|NCT03593473|141631671|SUPERIORITY|||||||0.834|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -15 to -10||||0.834
71061787|NCT03593473|141631671|SUPERIORITY|||||||0.7562|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -10 to -5||||0.7562
71061788|NCT03593473|141631671|SUPERIORITY|||||||0.4245|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -5 to 0||||0.4245
71061789|NCT03593473|141631671|SUPERIORITY|||||||0.1425|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 5 to 8||||0.1425
71061790|NCT03593473|141631671|SUPERIORITY|||||||0.7175|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 8 to 13||||0.7175
71061791|NCT03593473|141631671|SUPERIORITY|||||||0.1417|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 13 to 18||||0.1417
71061792|NCT03593473|141631671|SUPERIORITY|||||||0.0514|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 18 to 23||||0.0514
71061793|NCT03593473|141631671|SUPERIORITY|||||||0.1507|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 23 to 28||||0.1507
71061794|NCT03593473|141631671|SUPERIORITY|||||||0.4204|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 8 to 33||||0.4204
71061795|NCT03593473|141631671|SUPERIORITY|||||||0.4209|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 33 to 38||||0.4209
71061796|NCT03593473|141631671|SUPERIORITY|||||||0.2569|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 38 to 43||||0.2569
71061797|NCT03593473|141631671|SUPERIORITY|||||||0.0828|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 43 to 48||||0.0828
71061798|NCT03593473|141631672|SUPERIORITY|||||||0.6452|||||||t-test, 2 sided|||Pre-ejection period at minutes -40 to -35||||0.6452
71061799|NCT03593473|141631672|SUPERIORITY|||||||0.3228|||||||t-test, 2 sided|||Pre-ejection period at minutes -35 to -30||||0.3228
71061800|NCT03593473|141631672|SUPERIORITY|||||||0.3541|||||||t-test, 2 sided|||Pre-ejection period at minutes -30 to -25||||0.3541
70936837|NCT00824850|141373430|SUPERIORITY_OR_OTHER||difference in proportions|3.1|||||TWO_SIDED|95.0|-9.3|17.0||||||Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||17.0|-9.3|
71061801|NCT03593473|141631672|SUPERIORITY|||||||0.4311|||||||t-test, 2 sided|||Pre-ejection period at minutes -25 to -20||||0.4311
71061802|NCT03593473|141631672|SUPERIORITY|||||||0.3349|||||||t-test, 2 sided|||Pre-ejection period at minutes -20 to -15||||0.3349
71061803|NCT03593473|141631672|SUPERIORITY|||||||0.2646|||||||t-test, 2 sided|||Pre-ejection period at minutes -15 to -10||||0.2646
71061804|NCT03593473|141631672|SUPERIORITY|||||||0.1095|||||||t-test, 2 sided|||Pre-ejection period at minutes -10 to -5||||0.1095
71061805|NCT03593473|141631672|SUPERIORITY|||||||0.0194|||||||t-test, 2 sided|||Pre-ejection period at minutes -5 to 0||||0.0194
71061806|NCT03593473|141631672|SUPERIORITY|||||||0.473|||||||t-test, 2 sided|||Pre-ejection period at minutes 5 to 8||||0.473
71061807|NCT03593473|141631672|SUPERIORITY|||||||0.5768|||||||t-test, 2 sided|||Pre-ejection period at minutes 8 to 13||||0.5768
71061808|NCT03593473|141631672|SUPERIORITY|||||||0.3477|||||||t-test, 2 sided|||Pre-ejection period at minutes 13 to 18||||0.3477
71061809|NCT03593473|141631672|SUPERIORITY|||||||0.1413|||||||t-test, 2 sided|||Pre-ejection period at minutes 18 to 23||||0.1413
71061810|NCT03593473|141631672|SUPERIORITY|||||||0.2128|||||||t-test, 2 sided|||Pre-ejection period at minutes 23 to 28||||0.2128
71061811|NCT03593473|141631672|SUPERIORITY|||||||0.1415|||||||t-test, 2 sided|||Pre-ejection period at minutes 28 to 33||||0.1415
71061812|NCT03593473|141631672|SUPERIORITY|||||||0.1126|||||||t-test, 2 sided|||Pre-ejection period at minutes 33 to 38||||0.1126
71061813|NCT03593473|141631672|SUPERIORITY|||||||0.1647|||||||t-test, 2 sided|||Pre-ejection period at minutes 38 to 43||||0.1647
71061814|NCT03593473|141631672|SUPERIORITY|||||||0.088|||||||t-test, 2 sided|||Pre-ejection period at minutes 43 to 48||||0.088
71061815|NCT06700512|141631681|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|paired||"H0 (Objective 1) SRT (study HA) is either not significantly different from SRT without HAs or significantly worse than SRT without HAs.~H1(Objective 1) SRT(study HA) is significantly better than SRT without HAs. A mean difference in SRT of 1 dB measured with the Oldenburg sentence test can be assumed as a typical difference in speech intelligibility to show a clinically meaningful improvement."||||<0.001
71061816|NCT06700512|141631681|NON_INFERIORITY|A mean difference in SRT of 1 dB measured with the Oldenburg sentence test (Wagener et al, 1999a-c), can be assumed as a typical difference in speech intelligibility to show a clinically meaningful improvement (Kollmeier et al, 2011). Thus if SRT with study hearing aids is 1dB or more worse than with subjects' own hearing aids and the difference is significant (p\<0.05), inferiority of study hearing aid is assumed otherwise study hearing aids are considered non-inferior|||||<|0.001||||||paired|t-test, 1 sided|||H0 (Objective 2) SRT (study HA) is significantly worse than SRT(own HAs). H1(Objective 2) There is no difference between SRT(study HA) and SRT(own HAs) or SRT (study HA) is significantly better than SRT (own HAs) SRT= Speech Reception Threshold in dB||||<0.001
71061817|NCT02806908|141631712|SUPERIORITY|||||||0.0022|||||||ANOVA|||||||0.0022
71061818|NCT02806908|141631713|SUPERIORITY|||||||0.0416|||||||ANOVA|||||||0.0416
71061819|NCT02806908|141631714|SUPERIORITY|||||||0.0963|||||||McNemar|||||||0.0963
71061820|NCT02806908|141631715|SUPERIORITY|||||||0.3018|||||||McNemar|||||||0.3018
71061821|NCT02806908|141631716|SUPERIORITY|||||||0.424|||||||McNemar|||||||0.4240
71061822|NCT02806908|141631717|SUPERIORITY|||||||0.7539|||||||McNemar|||||||0.7539
71061823|NCT02806908|141631718|SUPERIORITY|||||||0.7539|||||||McNemar|||||||0.7539
71061824|NCT02806908|141631719|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
71061825|NCT02806908|141631720|SUPERIORITY|||||||0.6291|||||||McNemar|||||||0.6291
71061826|NCT02806908|141631721|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
70936838|NCT00824850|141373430|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
71061827|NCT02806908|141631722|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
70936839|NCT00824850|141373430|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
70936840|NCT00824850|141373430|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
70936841|NCT00824850|141373431|SUPERIORITY_OR_OTHER||difference in proportions|-2.6|||||TWO_SIDED|95.0|-13.9|8.0||||||7vPnC serotype 4: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||8.0|-13.9|
70936842|NCT00824850|141373431|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.2|10.6||||||7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.6|-10.2|
70936843|NCT00824850|141373431|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
71061828|NCT02806908|141631723|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
71061829|NCT02806908|141631724|SUPERIORITY|||||||0.7744|||||||McNemar|||||||0.7744
71061830|NCT02806908|141631725|SUPERIORITY|||||||0.7539|||||||McNemar|||||||0.7539
71061831|NCT02806908|141631726|SUPERIORITY|||||||0.1141|||||||ANOVA|||||||0.1141
71061832|NCT02806908|141631727|SUPERIORITY|||||||0.4441|||||||ANOVA|||||||0.4441
71110215|NCT00251693|141725997|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was supported if the lower bound of the 95% CI for the difference with lansoprazole 30 mg of the estimated 8-week healing rate was greater than -10%. Superiority was assessed based on log-rank tests comparing treatments for the endpoints.|Difference in percentage|6.08||||0.029||95.0|2.16|10.0||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Log Rank|||||10.00|2.16|0.029
70936844|NCT00824850|141373431|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.3||||||7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.5|
70936845|NCT00824850|141373431|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
70936846|NCT00824850|141373431|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.1|10.5||||||7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.5|-10.1|
70936847|NCT00824850|141373431|SUPERIORITY_OR_OTHER||difference in proportions|3.0|||||TWO_SIDED|95.0|-9.1|16.6||||||7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||16.6|-9.1|
70936848|NCT00824850|141373431|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
70936849|NCT00824850|141373431|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
70936850|NCT00824850|141373431|SUPERIORITY_OR_OTHER||difference in proportions|3.3|||||TWO_SIDED|95.0|-8.6|17.2||||||Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||17.2|-8.6|
70936851|NCT00824850|141373431|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
70936852|NCT00824850|141373431|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.7|10.6||||||Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.6|-9.7|
70936853|NCT00824850|141373431|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
70941736|NCT04748445|141383935|OTHER||Slope|2.799|STANDARD_ERROR_OF_MEAN|3.317||0.4005|TWO_SIDED|90.0|-2.698|8.296|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 13 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||8.296|-2.698|0.4005
71061833|NCT02806908|141631728|SUPERIORITY|||||||0.3423|||||||ANOVA|||||||0.3423
71061834|NCT02806908|141631729|SUPERIORITY|||||||0.9384|||||||ANOVA|||||||0.9384
71061835|NCT02806908|141631730|SUPERIORITY|||||||0.0939|||||||ANOVA|||||||0.0939
71061836|NCT02806908|141631731|SUPERIORITY|||||||0.0246|||||||ANOVA|||||||0.0246
71061837|NCT02806908|141631732|SUPERIORITY|||||||0.1475|||||||ANOVA|||||||0.1475
71061838|NCT02806908|141631733|SUPERIORITY|||||||0.1513|||||||ANOVA|||||||0.1513
71061839|NCT02806908|141631734|SUPERIORITY|||||||0.0002|||||||ANOVA|||||||0.0002
71061840|NCT02806908|141631735|SUPERIORITY|||||||0.0005|||||||ANOVA|||||||0.0005
71061841|NCT02806908|141631736|SUPERIORITY|||||||0.4774|||||||ANOVA|||||||0.4774
71061842|NCT02806908|141631737|SUPERIORITY|||||||0.3801|||||||ANOVA|||||||0.3801
71061843|NCT02806908|141631738|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71061844|NCT01760304|141631739|SUPERIORITY|||||||0.769|||||||2-sided paired t-test|||a paired t-test was calculated comparing baseline measures and post intervention||||0.769
71110216|NCT00251693|141725997|SUPERIORITY_OR_OTHER|||||||0.707||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.707
71061845|NCT01760304|141631739|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired T-test|||a paired t-test was calculated comparing baseline measures and post intervention||||<0.0001
71061846|NCT01760304|141631741|SUPERIORITY_OR_OTHER||||||<|0.05|||||||paired t-test|||||||<0.05
71061847|NCT04429503|141631742|NON_INFERIORITY|p-value for one-sided non-inferiority (NI) test at a margin of 4 letters|Least Square (LS) Mean Difference|-0.57|||<|0.0001|TWO_SIDED|95.0|-2.26|1.13|||Mixed Model for Repeated Measurements||HDq12 minus 2q8|||1.13|-2.26|<0.0001
71061848|NCT04429503|141631742|NON_INFERIORITY|p-value for one-sided non-inferiority (NI) test at a margin of 4 letters|LS Mean Difference|-1.44||||0.0031|TWO_SIDED|95.0|-3.27|0.39|||Mixed Model for Repeated Measurements||HDq16 minus 2q8|||0.39|-3.27|0.0031
71061849|NCT04429503|141631743|NON_INFERIORITY|The non-inferiority margin was set at 15%|Adjusted Difference (%)|1.98|||||TWO_SIDED|95.0|-6.61|10.57|||||Difference with confidence interval (CI) was calculated using Mantel-Haenszel weighting scheme adjusted for stratification factors|||10.57|-6.61|
71061850|NCT04429503|141631743|NON_INFERIORITY|The non-inferiority margin was set at 15%.|Adjusted Difference (%)|-7.52|||||TWO_SIDED|95.0|-16.88|1.84|||||Difference with confidence interval (CI) was calculated using Mantel-Haenszel weighting scheme adjusted for stratification factors|||1.84|-16.88|
71061851|NCT05516108|141631764|OTHER|||||||0.004|||||||Mixed Models Analysis|Stata mixed||time (pre, post, follow-up) x condition (mindfulness, coping)||||.004
71061852|NCT05516108|141631765|OTHER|||||||0.02|||||||Mixed Models Analysis|||time (pre, post, follow-up) x condition (mindfulness, coping)||||.020
71061853|NCT05516108|141631766|OTHER|||||||0.74|||||||Mixed Models Analysis|Stata melogit||time (pre, post, follow-up) x condition (mindfulness, coping)||||.74
71061854|NCT05516108|141631767|OTHER|||||||0.1|||||||Mixed Models Analysis|||time (pre, post, follow-up) x condition (mindfulness, coping)||||.10
71061855|NCT05516108|141631768|OTHER|||||||0.009|||||||Mixed Models Analysis|Stata mixed||time (pre, post, follow-up) x condition (mindfulness, coping)||||.009
71061856|NCT02550561|141631833|SUPERIORITY|||||||0.317||||||Subjects that reported either moderately or markedly improved on the GRA scale at 6 weeks compared to 12 weeks.|McNemar|||||||0.317
71061857|NCT02550561|141631834|OTHER|||||||0.47|||||||paired t-tests|||The mean change in Visual Analog Scale (VAS) score for bladder pain||||0.47
70936854|NCT01928732|141373439|SUPERIORITY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|1.0|1.65|||||Odds ratios were calculated with CPT as the reference group and reflect the overall main effect of treatment across all outcome assessments (post-treatment, 3-months, and 6-months)|Overall Treatment Effect Response Odds Ratio (OR). Response is defined as greater than or equal to 10 point improvement in severity.||1.65|1.00|
71061858|NCT02550561|141631834|OTHER|||||||0.17|||||||paired t-test|||The mean change in Pelvis Pain and Urgency/Frequency Patient Symptom (PUF) score||||0.17
71061859|NCT02550561|141631834|OTHER|||||||0.08|||||||paired t-test|||The mean change for O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI)||||.08
71061860|NCT02550561|141631834|OTHER|||||||0.51|||||||paired t-test|||The mean change O'Leary-Sant Interstitial Cystitis Problem Index (ICPI)||||0.51
71061861|NCT02550561|141631834|OTHER|||||||0.22|||||||paired t-test|||The mean change in 24-h urinary frequency||||0.22
71061862|NCT01051960|141631842|OTHER|comparison of means|Mean Difference (Final Values)|-93.0||||0.0008|TWO_SIDED|||||significant at p\<0.05|t-test, 2 sided|||Whether change from baseline to 24-weeks is significantly different from zero||||.0008
71061863|NCT01051960|141631843|OTHER||Mean Difference (Final Values)|44.5||||7e-05|TWO_SIDED||||||t-test, 2 sided|||change from baseline to 24 weeks||||0.00007
71061864|NCT00776035|141631888|SUPERIORITY||||||<|0.005|||||||Student's t-test|||Average myocardial blood flow, men versus women||||<0.005
71061865|NCT00776035|141631889|SUPERIORITY||||||<|0.05|||||||Student's t-test|||Average myocardial fatty acid utilization, men versus women||||<0.05
71061866|NCT00791778|141631890|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.655|TWO_SIDED|95.0|0.72|1.63|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.10 stratified by the same factors as randomization|Sorafenib compared to Placebo|Sample size based on the primary efficacy endpoint of PFS. Clinically meaningful improvement defined as 65% increase in median PFS. With one-sided alpha of 0.10, power of 90% and a randomization ratio of 1:1 between Sorafenib and Placebo, a total of 105 PFS events were required.||1.63|0.72|0.655
71061867|NCT00791778|141631891|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.43||||0.951|TWO_SIDED|95.0|0.93|2.2|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.10 stratified by the same factors as randomization|Sorafenib compared to Placebo|||2.20|0.93|0.951
71061868|NCT00791778|141631892|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49||||0.84|TWO_SIDED|95.0|0.69|3.23|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.10 stratified by the same factors as randomization.|Sorafenib compared to Placebo|||3.23|0.69|0.84
71061869|NCT03335475|141631932|SUPERIORITY|||||||0.24|||||||Mixed Models Analysis|||||||0.24
71061870|NCT03335475|141631933|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|||||||0.70
71061871|NCT03335475|141631934|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||||||0.21
71061872|NCT02224157|141632008|NON_INFERIORITY|Non-inferiority analysis based on CI instead of p-value, hence no p-value calculated for this analysis. Upper limit of the 1-sided 95% confidence limit \<1.2 indicates Symbicort 'as needed' is non-inferior to Pulmicort bid|Rate ratio|0.97|||||ONE_SIDED|95.0||1.16|||Negative binomial model|Adjusted for randomised treatment, pre-study treatment and region. Logarithm of follow-up time is used as an offset variable.|A rate ratio less than 1 indicates a lower rate of exacerbations in the Symbicort 'as needed' treatment group.|||1.16||
71061873|NCT02224157|141632009|SUPERIORITY||Hazard Ratio (HR)|0.955||||0.664|TWO_SIDED|95.0|0.777|1.174|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first severe exacerbation.|||1.174|0.777|0.664
71061874|NCT02224157|141632010|SUPERIORITY||Least Square Mean Difference|-32.6||||0.003|TWO_SIDED|95.0|-53.7|-11.4|||Mixed Models Analysis|Rand treatment,pre-study treatment,region,visit,rand treatment by visit; fixed effects. Patient; random effect, baseline FEV1; covariate.|Mean difference greater than 0 favours Symbicort 'as needed'. Estimate corresponds to average treatment effect across all treatment visits.|||-11.4|-53.7|0.003
71110217|NCT00251693|141725998|SUPERIORITY_OR_OTHER|||||||0.705||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.705
71110218|NCT00251693|141725998|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.146
71110219|NCT00251693|141725998|SUPERIORITY_OR_OTHER|||||||0.283||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.283
71110220|NCT00251693|141725999|SUPERIORITY_OR_OTHER|||||||0.896||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.896
71110221|NCT00251693|141725999|SUPERIORITY_OR_OTHER|||||||0.241||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.241
71110222|NCT00251693|141725999|SUPERIORITY_OR_OTHER|||||||0.211||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Log Rank|||||||0.211
71110223|NCT04571060|141726008|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|8.8|||<|0.0001|TWO_SIDED|95.0|4.5|13.1||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||13.1|4.5|<0.0001
71110224|NCT04571060|141726009|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|8.7||||0.0012|TWO_SIDED|95.0|3.4|13.9||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||13.9|3.4|0.0012
71110225|NCT04571060|141726010|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|9.0||||0.0012|TWO_SIDED|95.0|3.6|14.5||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||14.5|3.6|0.0012
70936855|NCT01928732|141373439|SUPERIORITY||Odds Ratio (OR)|1.43|||||TWO_SIDED|95.0|1.12|1.74|||||Odds ratios were calculated with CPT as the reference group and reflect the overall main effect of treatment across all outcome assessments (post-treatment, 3-months, and 6-months)|Overall Treatment Effect Loss of Diagnosis Odds Ratio (OR). Loss of Diagnosis is defined as Response, plus no longer meeting DSM-5 symptom criteria and severity less than 25.||1.74|1.12|
71110226|NCT04571060|141726011|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|10.2||||0.0001|TWO_SIDED|95.0|5.0|15.5||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||15.5|5.0|0.0001
71110227|NCT04571060|141726012|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|7.6||||0.0048|TWO_SIDED|95.0|2.3|12.9||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||12.9|2.3|0.0048
71110228|NCT04571060|141726013|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|6.5||||0.013|TWO_SIDED|95.0|1.4|11.7||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||11.7|1.4|0.0130
71110229|NCT04571060|141726014|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|4.9||||0.0076|TWO_SIDED|95.0|1.3|8.5||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||8.5|1.3|0.0076
71110230|NCT04571060|141726015|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|3.7||||0.0308|TWO_SIDED|95.0|0.3|7.1||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||7.1|0.3|0.0308
71110231|NCT04571060|141726016|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|8.3||||0.0123|TWO_SIDED|95.0|1.8|14.9||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||14.9|1.8|0.0123
71110232|NCT04571060|141726017|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|8.6||||0.0018|TWO_SIDED|95.0|3.2|14.1||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||14.1|3.2|0.0018
71110233|NCT04571060|141726018|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|6.0||||0.0293|TWO_SIDED|95.0|0.6|11.4||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||11.4|0.6|0.0293
71110234|NCT04571060|141726019|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|4.7||||0.0362|TWO_SIDED|95.0|0.3|9.1||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||9.1|0.3|0.0362
71110235|NCT04571060|141726020|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|10.2|||<|0.0001|TWO_SIDED|95.0|5.5|15.0||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||15.0|5.5|<0.0001
71110236|NCT04571060|141726021|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|4.4||||0.0059|TWO_SIDED|95.0|1.3|7.6||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||7.6|1.3|0.0059
71110237|NCT04571060|141726022|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|7.8|||<|0.0001|TWO_SIDED|95.0|4.2|11.3||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||11.3|4.2|<0.0001
71110238|NCT01361217|141726032|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71110239|NCT01361217|141726032|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71110240|NCT01361217|141726033|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71110241|NCT04970069|141726069|SUPERIORITY||Ratio of geometric means|1.01||||0.89|TWO_SIDED|95.0|0.86|1.18|||Regression, Linear||The numerator and denominator for the ratio of geometric means are analgesic education and general preoperative education respectively.|Multiple imputation by chained equations (MICE) was used for imputing missing outcomes and covariates.||1.18|0.86|0.890
70936856|NCT01928732|141373439|SUPERIORITY||Odds Ratio (OR)|1.62|||||TWO_SIDED|95.0|1.24|2.0|||||Odds ratios were calculated with CPT as the reference group and reflect the overall main effect of treatment across all outcome assessments (post-treatment, 3-months, and 6-months)|Overall Treatment Effect Remission Odds Ratio (OR). Remission is defined as loss of diagnosis plus severity less than 12.||2.00|1.24|
71110242|NCT04970069|141726070|SUPERIORITY||Median Difference (Final Values)|-0.1||||0.617|TWO_SIDED|95.0|-0.3|0.2|||Regression, Linear|||||0.2|-0.3|0.617
71110243|NCT04970069|141726071|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.611|TWO_SIDED|95.0|-0.3|0.2|||Regression, Linear|||||0.2|-0.3|0.611
71110244|NCT01328743|141726082|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||.04
71061875|NCT02224157|141632012|SUPERIORITY||Least Square Mean Difference|0.03|||||TWO_SIDED|95.0|0.0|0.07||No p-value was calculated for this efficacy variable|ANCOVA|Model with randomised treatment, pre-study treatment and region as factors, and no. of 'as needed' inhalations at baseline as continuous covariate|A mean difference less than zero indicates a larger mean reduction in number of 'as needed' inhalations in the Symbicort 'as needed' group.|||0.07|0.00|
71061876|NCT02224157|141632013|SUPERIORITY||Least Square Mean Difference|-6.85|||<|0.001|TWO_SIDED|95.0|-8.37|-5.34|||ANCOVA|adjusted for randomised treatment, pre-study treatment and region as factors and the percent 'as needed' free days during run-in as a cont covariate.|An estimate of difference \>0 means that there was a larger increase in the % of 'as needed' free days in the Symbicort 'as-needed' arm.|||-5.34|-8.37|< 0.001
71061877|NCT02224157|141632014|SUPERIORITY||Least Square Mean Difference|-37.48|||<|0.001|TWO_SIDED|95.0|-39.18|-35.77|||ANOVA|model adjusted for: randomised treatment, pre-study treatment and region.|An estimate of difference \>0 means that there was a higher % of controller use days in the Symbicort 'as-needed' group.|||-35.77|-39.18|<0.001
71061878|NCT02224157|141632015|SUPERIORITY||Least Square Mean Difference|0.109|||<|0.001|TWO_SIDED|95.0|0.068|0.15|||Mixed Models Analysis|rand treatment, pre-study treatment, region, visit, rand treat by visit as fixed, patient as random, and baseline ACQ-5 as covariate.|Mean difference less than 0 favours Symbicort 'as needed'.|||0.150|0.068|<0.001
71061879|NCT02224157|141632016|SUPERIORITY||Least Square Mean Difference|-0.096|||<|0.001|TWO_SIDED|95.0|-0.137|-0.054|||Mixed Models Analysis|rand treatment, pre-study treatment, region, visit, rand treat by visit as fixed, patient as random and baseline AQLQ as covariate.|Mean difference greater than 0 favours Symbicort 'as needed'.|||-0.054|-0.137|<0.001
71061880|NCT02224157|141632017|SUPERIORITY||Rate ratio|0.97||||0.754|TWO_SIDED|95.0|0.78|1.2|||Negative binomial model|Adjusted for randomised treatment, pre-study treatment and region. Logarithm of follow-up time is used as an offset variable.|A rate ratio less than 1 indicates a lower rate of exacerbations in the Symbicort 'as needed' treatment group.|||1.20|0.78|0.754
71061881|NCT05906628|141632045|SUPERIORITY||Odds Ratio (OR)|9.82|||<|0.0001|TWO_SIDED|95.0|4.48|21.49|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by stratification factors IGA-CHE score (3 or 4) and region (North America or outside of North America).||||21.49|4.48|<0.0001
71061882|NCT05906628|141632045|SUPERIORITY||Response rate difference|42.5|STANDARD_ERROR_OF_MEAN|6.03|||TWO_SIDED|95.0|30.7|54.36||||||||54.36|30.70|
71061883|NCT05906628|141632046|SUPERIORITY||Odds Ratio (OR)|4.23|||<|0.0001|TWO_SIDED|95.0|2.14|8.38|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by stratification factors IGA-CHE score (3 or 4) and region (North America or outside of North America).||Week 4||8.38|2.14|<0.0001
71061884|NCT05906628|141632046|SUPERIORITY||Response rate difference|29.5|STANDARD_ERROR_OF_MEAN|6.52|||TWO_SIDED|95.0|16.69|42.24||||||Week 4||42.24|16.69|
71061885|NCT05906628|141632046|SUPERIORITY||Odds Ratio (OR)|3.9|||<|0.0001|TWO_SIDED|95.0|2.02|7.51|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by stratification factors IGA-CHE score (3 or 4) and region (North America or outside of North America).||Week 16||7.51|2.02|<0.0001
70936857|NCT01185340|141373447|SUPERIORITY_OR_OTHER|||||||0.751|||||||Mixed Models Analysis|||||||0.751
70936858|NCT00087516|141373466|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.79|STANDARD_ERROR_OF_MEAN|0.09|<|0.001||95.0|-0.96|-0.62|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline A1C||||-0.62|-0.96|<0.001
71061886|NCT05906628|141632046|SUPERIORITY||Response rate difference|29.5|STANDARD_ERROR_OF_MEAN|6.69|||TWO_SIDED|95.0|16.34|42.57||||||Week 16||42.57|16.34|
71061887|NCT05906628|141632047|SUPERIORITY||Odds Ratio (OR)|2.06||||0.1789|TWO_SIDED|95.0|0.718|5.923|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by stratification factors IGA-CHE score (3 or 4) and region (North America or outside of North America).||Day 3||5.923|0.718|0.1789
71061888|NCT05906628|141632047|SUPERIORITY||Odds Ratio (OR)|3.79||||0.0024|TWO_SIDED|95.0|1.603|8.951|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by stratification factors IGA-CHE score (3 or 4) and region (North America or outside of North America).||Week 1 (Day 7)||8.951|1.603|0.0024
71061889|NCT05906628|141632048|SUPERIORITY||Odds Ratio (OR)|9.91|||<|0.0001|TWO_SIDED|95.0|4.44|22.13|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by stratification factors IGA-CHE score (3 or 4) and region (North America or outside of North America).||Week 16||22.13|4.44|<0.0001
71061890|NCT05906628|141632048|SUPERIORITY||Response rate difference|45.6|STANDARD_ERROR_OF_MEAN|6.49|||TWO_SIDED|95.0|32.83|58.27||||||Week 16||58.27|32.83|
71061891|NCT05906628|141632050|SUPERIORITY||Cox regression model|1.719||||0.0025|TWO_SIDED|95.0|1.211|2.44|||Log Rank|stratified by randomization stratification factors|Cox regression model stratified by stratification factors (Baseline IGA-CHE 3/4, Region : North America or outside of North America) was conducted to compare the difference in hazard rate between treatment and vehicle.|||2.440|1.211|0.0025
71061892|NCT05906628|141632053|SUPERIORITY||Cox regression model|1.279||||0.1319|TWO_SIDED|95.0|0.931|1.759|||Log Rank|stratified by randomization stratification factors|Cox regression model stratified by stratification factors (Baseline IGA-CHE 3/4, Region : North America or outside of North America) was conducted to compare the difference in hazard rate between treatment and vehicle.|||1.759|0.931|0.1319
71061893|NCT05317312|141632076|SUPERIORITY||Mean Difference (Final Values)|18.7|STANDARD_ERROR_OF_MEAN|12.08||0.123|TWO_SIDED|95.0|-5.2|42.7|||Emax||The estimated difference between 1.25mg bid and placebo is based on the Emax model. The values that appear in the Outcome Measure Data Table are observed values.|||42.7|-5.2|0.123
71061894|NCT05317312|141632076|SUPERIORITY||Mean Difference (Final Values)|34.7|STANDARD_ERROR_OF_MEAN|10.25|<|0.001|TWO_SIDED|95.0|14.4|55.0|||Emax||||The estimated difference between 5mg bid and placebo is based on the Emax model. The values that appear in the Outcome Measure Data Table are observed values.|55.0|14.4|<0.001
71061895|NCT05317312|141632076|SUPERIORITY||Mean Difference (Final Values)|42.8|STANDARD_ERROR_OF_MEAN|9.53|<|0.001|TWO_SIDED|95.0|23.9|61.7|||Emax||The estimated difference between 15mg bid and placebo is based on the Emax model. The values that appear in the Outcome Measure Data Table are observed values.|||61.7|23.9|<0.001
71061896|NCT05317312|141632077|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-2.0|0.2|||||The estimated difference between 1.5mg bid and placebo is based on Mixed Model Repeated Measures.The values in the Outcome Measure Data are observed mean values.|||0.2|-2.0|
71061897|NCT05317312|141632077|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-1.8|0.4|||||The estimated difference between 5mg bid and placebo is based on Mixed Model Repeated Measures. The values in the Outcome Measure Data are observed mean values|||0.4|-1.8|
71061898|NCT05317312|141632077|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-1.9|0.3|||||The estimated difference between 15mg bid and placebo is based on Mixed Model Repeated Measures.. The values in the Outcome Measure Data are observed mean values|||0.3|-1.9|
71061899|NCT05317312|141632078|SUPERIORITY|||||||0.036|||||||Log Rank|||||||0.036
71061900|NCT05317312|141632078|SUPERIORITY|||||||0.006|||||||Log Rank|||||||0.006
71061901|NCT05317312|141632078|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
71061902|NCT05317312|141632079|SUPERIORITY|||||||0.411|||||||Log Rank|||||||0.411
71061903|NCT05317312|141632079|SUPERIORITY|||||||0.383|||||||Log Rank|||||||0.383
71061904|NCT05317312|141632079|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
71061905|NCT05317312|141632080|SUPERIORITY||Risk Difference (RD)|27.4||||0.042|TWO_SIDED|95.0|2.0|52.7|||Chi-squared|||||52.7|2.0|0.042
71061906|NCT05317312|141632080|SUPERIORITY||Risk Difference (RD)|34.5||||0.01|TWO_SIDED|95.0|9.7|59.3|||Chi-squared|||||59.3|9.7|0.01
71061907|NCT05317312|141632080|SUPERIORITY||Risk Difference (RD)|51.9|||<|0.001|TWO_SIDED|95.0|29.6|74.1|||Chi-squared|||||74.1|29.6|<0.001
71061908|NCT05317312|141632081|SUPERIORITY||Risk Difference (RD)|-31.2||||0.019|TWO_SIDED|95.0|-55.9|-6.5|||Chi-squared|||||-6.5|-55.9|0.019
71061909|NCT05317312|141632081|SUPERIORITY||Risk Difference (RD)|-16.9||||0.187|TWO_SIDED|95.0|-41.6|7.8|||Chi-squared|||||7.8|-41.6|0.187
71061910|NCT05317312|141632081|SUPERIORITY||Risk Difference (RD)|-44.4||||0.001|TWO_SIDED|95.0|-68.3|20.6|||Chi-squared|||||20.6|-68.3|0.001
71061911|NCT00380874|141632088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.08||0.2536||||||Cycle 1. No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 1. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.2536
71061912|NCT00380874|141632088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.23||0.5757||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 2. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.5757
71061913|NCT00380874|141632088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.3||0.6065||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 3. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.6065
71061914|NCT00380874|141632088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.31||0.4301||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 4. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.4301
71061915|NCT00380874|141632088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.49||0.3125||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 5. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.3125
71110245|NCT01328743|141726083|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<.01
71110246|NCT01328743|141726084|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<.01
71110247|NCT01328743|141726085|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||.48
71110248|NCT01328743|141726086|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||.25
71110249|NCT01328743|141726087|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
71110250|NCT01900665|141726088|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.095|TWO_SIDED|95.0|-1.73|0.14|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate the denominator degrees of freedom.||||0.14|-1.73|0.095
71110251|NCT02481258|141726106|EQUIVALENCE|Power calculations were based on a two-sample t-test. A priori calculations to detect an effect size of 0.57 units indicated that that 50 patients per arm were needed to have 80% power. The actual effect size observed in the present study was 0.86.||||||0.05|||||||ANCOVA|||The statistical analysis was done using an ANCOVA analysis adjusting for the baseline aortic valve calcium levels.||||0.05
71110252|NCT02481258|141726108|EQUIVALENCE|Power calculations were based on a two-sample t-tests assuming initial recruitment of 50 subjects.|||||>|0.05||||||Our a priori threshold for statistical significance was p \< 0.05.|ANCOVA|||||||>0.05
71110253|NCT02481258|141726109|EQUIVALENCE|Power calculations were based on a two-sample t-test.|||||>|0.05||||||Our a priori threshold for statistical significance was p \< 0.05.|ANCOVA|||The statistical analysis was done using an ANCOVA analysis adjusting for the baseline aortic valve calcium levels.||||>0.05
71110254|NCT04050384|141726124|OTHER||||||<|0.001|||||||ANCOVA|These analyses apply to the Frontal, Central, and Central-Parietal regions.||||||<0.001
71110255|NCT04050384|141726125|OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
71061916|NCT00380874|141632088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.41||0.8169||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 6.Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.8169
71061917|NCT00380874|141632088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.4||0.9359|||||||ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 7. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.9359
71061918|NCT00380874|141632088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.4||0.6233|||||||ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 8. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.6233
71061919|NCT00380874|141632088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.5||0.1569||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 9.Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.1569
71061920|NCT00380874|141632089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.11||0.7207||95.0|-0.25|0.17||Model terms include treatment, study center, and baseline score.|ANCOVA|Cycle 1. No multiple comparisons adjustment was made.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 1.||0.17|-0.25|0.7207
71110256|NCT04472650|141726137|OTHER||Ratio of Geometric Least Squares Means|87.63|||||TWO_SIDED|90.0|78.273|98.111||||||Sitravatinib Malate Salt Capsule (Test) vs. Sitravatinib Free Base Capsule (Reference). Analysis based on Relative Bioavailability Analysis Set, defined as the subset of participants in the PK Parameters Analysis Set who had at least 1 primary PK parameter (AUC0-t, AUC0-inf and Cmax of sitravatinib) in both periods.||98.111|78.273|
71110257|NCT04472650|141726138|OTHER||Ratio of Geometric Least Squares Means|87.5|||||TWO_SIDED|90.0|78.12|98.01||||||Sitravatinib Malate Salt Capsule (Test) vs. Sitravatinib Free Base Capsule (Reference). Analysis based on Relative Bioavailability Analysis Set, defined as the subset of participants in the PK Parameters Analysis Set who had at least 1 primary PK parameter (AUC0-t, AUC0-inf and Cmax of sitravatinib) in both periods.||98.01|78.12|
71110258|NCT04472650|141726139|OTHER||Ratio of Geometric Least Squares Means|88.8|||||TWO_SIDED|90.0|77.41|101.87||||||Sitravatinib Malate Salt Capsule (Test) vs. Sitravatinib Free Base Capsule (Reference). Analysis based on Relative Bioavailability Analysis Set, defined as the subset of participants in the PK Parameters Analysis Set who had at least 1 primary PK parameter (AUC0-t, AUC0-inf and Cmax of sitravatinib) in both periods.||101.87|77.41|
71110259|NCT00298389|141726146|SUPERIORITY|||||||0.05||||||calculated|Kruskal-Wallis|||||||0.05
71110260|NCT00298389|141726147|SUPERIORITY|||||||0.05|||||||Kruskal-Wallis|||||||0.05
71110261|NCT00288015|141726148|OTHER|This is a two-stage optimal simon design. If bevacizumab is not effective, there is a 0.050 probability of concluding that it is. If bevacizumab is effective, there is a 0.2000 probability of concluding that it is not.||||||||||||In first stage 12 patients will be entered, if \</=3 patients have PFS time\>3 months p\</=0.22 is likely true. In second stage a total of up to 31 patients data will be analysed. If \>/=10 patients show PFS\</=3 months, it will suggest p\>0.50 is true.|Kaplan-Meier estimate|||This is a two stage optimal simon design testing the Null hypothesis: bevacizumab is not effective with P\<=0.220 and the alternative hypothesis: bevacizumab is effective with P \>=0.450 and has a sample size of 16.96 and a probability of early termination of 0.739. p=probability (progression free survival - PFS time\>/=3 months).|P\<=0.220 is the threshold value of significance that the null hypothesis is true or the alternative hypothesis is true. P Value was not calculated from the data. Median survival time was calculated using a 20% censored Kaplan-Meier table and graph.|||
71061921|NCT00380874|141632089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.36||0.3111||95.0|-0.36|1.1||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 2.||1.10|-0.36|0.3111
71110262|NCT02383862|141726174|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|0.79||0.165|TWO_SIDED|95.0|-0.45|2.64|||t-test, 2 sided|||||2.64|-0.45|0.165
71110263|NCT02383862|141726175|SUPERIORITY||Mean Difference (Final Values)|0.84|STANDARD_ERROR_OF_MEAN|1.05||0.425|TWO_SIDED|95.0|-1.23|2.91|||t-test, 2 sided|||||2.91|-1.23|0.425
71110264|NCT02383862|141726176|SUPERIORITY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|1.05||0.539|TWO_SIDED|95.0|-1.41|2.7|||t-test, 2 sided|||||2.70|-1.41|0.539
71110265|NCT02383862|141726177|SUPERIORITY||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|1.16||0.471|TWO_SIDED|95.0|-1.44|3.11|||t-test, 2 sided|||||3.11|-1.44|0.471
71110266|NCT02383862|141726178|SUPERIORITY||Mean Difference (Final Values)|1.49|STANDARD_ERROR_OF_MEAN|1.1||0.174|TWO_SIDED|95.0|-0.66|3.65|||t-test, 2 sided|||||3.65|-0.66|0.174
71110267|NCT02383862|141726179|SUPERIORITY||Mean Difference (Final Values)|1.67|STANDARD_ERROR_OF_MEAN|1.36||0.222|TWO_SIDED|95.0|-1.0|4.35|||t-test, 2 sided|||||4.35|-1.00|0.222
71061922|NCT00380874|141632089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.48||0.5925||95.0|-0.7|1.22||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 3.||1.22|-0.70|0.5925
71110268|NCT01664247|141726210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.34|||<|0.0001|TWO_SIDED|95.0|-2.67|-2.01|||ANOVA||The treatment contrast estimated was IDeg - Placebo.|The pre-breakfast measures of SMPG values after 26 weeks of treatment were analysed an ANOVA method with treatment, region and sex as fixed effects, and age and baseline response as covariates.||-2.01|-2.67|<.0001
71110269|NCT01664247|141726211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.69|||<|0.0001|TWO_SIDED|95.0|-3.04|-2.34|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point before breakfast.||-2.34|-3.04|<.0001
70936859|NCT00087516|141373466|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.94|STANDARD_ERROR_OF_MEAN|0.09|<|0.001||95.0|-1.11|-0.77|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline A1C||||-0.77|-1.11|<0.001
71110270|NCT01664247|141726211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.09|||<|0.0001|TWO_SIDED|95.0|-2.71|-1.48|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point 90 mins after breakfast.||-1.48|-2.71|<.0001
71110271|NCT01664247|141726211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.01|||<|0.0001|TWO_SIDED|95.0|-2.47|-1.56|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point before lunch.||-1.56|-2.47|<.0001
71110272|NCT01664247|141726211|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.93|||<|0.0001|TWO_SIDED|95.0|-2.46|-1.4|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point 90 mins after start of lunch.||-1.40|-2.46|<.0001
71110273|NCT01664247|141726211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.74|||<|0.0001|TWO_SIDED|95.0|-2.25|-1.23|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point main evening meal.||-1.23|-2.25|<.0001
71110274|NCT01664247|141726211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|||<|0.0001|TWO_SIDED|95.0|-2.26|-1.18|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point 90 mins after main evening meal.||-1.18|-2.26|<.0001
71110275|NCT01664247|141726211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75|||<|0.0001|TWO_SIDED|95.0|-2.27|-1.23|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point before bedtime.||-1.23|-2.27|<.0001
70936860|NCT00087516|141373467|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.1|STANDARD_ERROR_OF_MEAN|3.6|<|0.001||95.0|-24.1|-10.1|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline FPG||||-10.1|-24.1|<0.001
70936861|NCT00087516|141373467|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.3|STANDARD_ERROR_OF_MEAN|3.5|<|0.001||95.0|-28.2|-14.4|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline FPG||||-14.4|-28.2|<0.001
70936862|NCT00087516|141373468|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-46.7|STANDARD_ERROR_OF_MEAN|6.5|<|0.001||95.0|-59.4|-34.1|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline 2-hr PMG||||-34.1|-59.4|<0.001
70936863|NCT00087516|141373468|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-54.1|STANDARD_ERROR_OF_MEAN|6.4|<|0.001||95.0|-66.7|-41.6|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline 2-hr PMG||||-41.6|-66.7|<0.001
70936864|NCT02065895|141373472|OTHER|ANOVA was used to first tests the hypothesis that there is a difference among the three groups.|Mean Difference (Final Values)|66.8||||0.0011|TWO_SIDED|95.0|33.4|80.3||The p value was adjusted for multiple comparisons using Sidak's correction. A priori the pimary outcome was defined as blood glucose AUC from 8 am - 12pm; however we used blood glucose AUC from 8am - 2pm to capture the entire meal response.|ANOVA|||Differences among the 3 groups were assessed by repeated measures ANOVA using Sidak's correction for multiple comparisons. All subjects were analyzed as a single group, no comparison group.||80.3|33.4|0.0011
70936865|NCT02065895|141373473|OTHER|||||||0.0059|||||||ANOVA|||||||0.0059
70936866|NCT01093690|141373475|SUPERIORITY_OR_OTHER|||||||0.41||||||No adjustment.|Chi-squared|1-sided test||the study had 80 percent power to detect an absolute difference of 20 percent in complete response (70% for metoclopramide group vs 50% for control group)||||0.41
70936867|NCT00569166|141373479|SUPERIORITY_OR_OTHER|||||||0.3679||95.0|||||Wilcoxon rank-sum|||Treatment effectiveness was measured using pairwise comparisons of hot flash score change from baseline in each paced breathing arm.||||0.3679
70936868|NCT00569166|141373479|SUPERIORITY_OR_OTHER|||||||0.4715||95.0|||||Wilcoxon rank-sum|||Treatment effectiveness was measured using pairwise comparisons of hot flash score change from baseline in each paced breathing arm.||||0.4715
70936869|NCT00486954|141373526|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.2088|TWO_SIDED|95.0|0.64|1.11|||Log Rank|||||1.11|0.64|0.2088
70936870|NCT01836523|141373585|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper bound of 95% confidence interval was \<0.3.|Treatment difference|-0.2|||||TWO_SIDED|95.0|-0.32|-0.07||||||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.||-0.07|-0.32|
70936871|NCT01836523|141373585|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper bound of 95% confidence interval was \<0.3.|Treatment difference|-0.15|||||TWO_SIDED|95.0|-0.27|-0.03||||||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.||-0.03|-0.27|
70936872|NCT01836523|141373585|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper bound of 95% confidence interval was \<0.3.|Treatment difference|-0.09|||||TWO_SIDED|95.0|-0.21|0.03||||||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.||0.03|-0.21|
70936873|NCT01836523|141373586|SUPERIORITY_OR_OTHER||Treatment difference|-4.9|||<|0.0001|TWO_SIDED|95.0|-5.65|-4.16|||Mixed Models Analysis|||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.||-4.16|-5.65|<0.0001
70936874|NCT01836523|141373586|SUPERIORITY_OR_OTHER||Treatment difference|-3.55|||<|0.0001|TWO_SIDED|95.0|-4.29|-2.81|||Mixed Models Analysis|||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.||-2.81|-4.29|<0.0001
70941737|NCT04748445|141383935|OTHER||Slope|1.123|STANDARD_ERROR_OF_MEAN|1.676||0.504|TWO_SIDED|90.0|-1.654|3.901|||Mixed Models Analysis|||MM\_Coefficient of Variation F0 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||3.901|-1.654|0.5040
70936875|NCT01836523|141373586|SUPERIORITY_OR_OTHER||Treatment difference|-2.19|||<|0.0001|TWO_SIDED|95.0|-2.91|-1.47|||Mixed Models Analysis|||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.||-1.47|-2.91|<0.0001
70936876|NCT01836523|141373587|SUPERIORITY_OR_OTHER||Treatment ratio|0.92|||<|0.0001|TWO_SIDED|95.0|0.88|0.96|||Mixed Models Analysis|||Analysis was done using MMRMs where all post-baseline measurements for specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as dependent variable, and visit, treatment, country and stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate. The measurements were log-transformed before analysis||0.96|0.88|<0.0001
70936877|NCT01836523|141373587|SUPERIORITY_OR_OTHER||Treatment ratio|0.95||||0.0148|TWO_SIDED|95.0|0.91|0.99|||Mixed Models Analysis|||Analysis was done using MMRMs where all post-baseline measurements for specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as dependent variable, and visit, treatment, country and stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate. The measurements were log-transformed before analysis||0.99|0.91|0.0148
70936878|NCT01836523|141373587|SUPERIORITY_OR_OTHER||Treatment ratio|1.0||||0.9615|TWO_SIDED|95.0|0.96|1.04|||Mixed Models Analysis|||Analysis was done using MMRMs where all post-baseline measurements for specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as dependent variable, and visit, treatment, country and stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate. The measurements were log-transformed before analysis||1.04|0.96|0.9615
71061923|NCT00380874|141632089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.55||0.5812||95.0|-0.8|1.41||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 4.||1.41|-0.80|0.5812
71061924|NCT00380874|141632089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.75|STANDARD_ERROR_OF_MEAN|0.7||0.2925||95.0|-0.67|2.16||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 5.||2.16|-0.67|0.2925
71061925|NCT00380874|141632089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.54||0.9276||95.0|-1.15|1.05||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 6.||1.05|-1.15|0.9276
71110276|NCT01664247|141726211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|||<|0.0001|TWO_SIDED|95.0|-2.91|-2.09|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point before breakfast the following day.||-2.09|-2.91|<.0001
71110277|NCT01118780|141726237|SUPERIORITY_OR_OTHER||LS mean difference|4.17|STANDARD_ERROR_OF_MEAN|0.86|<|0.001|TWO_SIDED|95.0|2.47|5.88|||Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||5.88|2.47|<0.001
71110278|NCT01118780|141726238|SUPERIORITY_OR_OTHER||LS mean difference|3.23|STANDARD_ERROR_OF_MEAN|0.82|<|0.001|TWO_SIDED|95.0|1.61|4.85|||Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||4.85|1.61|<0.001
71110279|NCT01118780|141726239|SUPERIORITY_OR_OTHER||LS mean difference|2.4|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|1.43|3.37||The p-value is for the change from baseline to Week 10 in the HAMA Psychic Anxiety Factor Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||3.37|1.43|<0.001
71061926|NCT00380874|141632089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.53||0.9952||95.0|-1.06|1.07|||ANCOVA|Model terms include treatment, study center, and baseline score.||Cycle 7.||1.07|-1.06|0.9952
71061927|NCT00380874|141632089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.55||0.6265||95.0|-0.85|1.38|||ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 8.||1.38|-0.85|0.6265
71110280|NCT01118780|141726239|SUPERIORITY_OR_OTHER||LS mean difference|1.76|STANDARD_ERROR_OF_MEAN|0.45|<|0.001|TWO_SIDED|95.0|0.87|2.65||The p-value is for the change from baseline to Week 10 in the HAMA Somatic Anxiety Factor Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||2.65|0.87|<0.001
71110281|NCT01118780|141726239|SUPERIORITY_OR_OTHER||LS mean difference|0.52|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|0.3|0.74||The p-value is for the change from baseline to Week 10 in the HAMA Anxious Mood Item Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.74|0.30|<0.001
71110282|NCT01118780|141726239|SUPERIORITY_OR_OTHER||LS mean difference|0.31|STANDARD_ERROR_OF_MEAN|0.11||0.007|TWO_SIDED|95.0|0.09|0.53||The p-value is for the change from baseline to Week 10 in the HAMA Tension Item Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.53|0.09|0.007
71110283|NCT01118780|141726240|SUPERIORITY_OR_OTHER||LS mean difference|2.19|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|1.2|3.18||The p-value is for the change from baseline to Week 10 in the HADS Anxiety Subscale Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||3.18|1.20|<0.001
70936879|NCT01836523|141373588|SUPERIORITY_OR_OTHER||Rate ratio|1.31||||0.0081|TWO_SIDED|95.0|1.07|1.59|||Negative binomial regression|||The endpoint was analysed using a negative binomial regression model with a log-link function and the log of the time period in which an occurrence of a hypoglycaemic episode was considered treatment emergent as offset. The model included fixed factors (treatment, country, stratification group) and a covariate (baseline HbA1c).||1.59|1.07|0.0081
70936880|NCT01836523|141373588|SUPERIORITY_OR_OTHER||Rate ratio|1.27||||0.0219|TWO_SIDED|95.0|1.03|1.55|||Negative binomial regression|||The endpoint was analysed using a negative binomial regression model with a log-link function and the log of the time period in which an occurrence of a hypoglycaemic episode was considered treatment emergent as offset. The model included fixed factors (treatment, country, stratification group) and a covariate (baseline HbA1c).||1.55|1.03|0.0219
70936881|NCT01836523|141373588|SUPERIORITY_OR_OTHER||Rate ratio|1.17||||0.1079|TWO_SIDED|95.0|0.97|1.43|||Negative binomial regression|||The endpoint was analysed using a negative binomial regression model with a log-link function and the log of the time period in which an occurrence of a hypoglycaemic episode was considered treatment emergent as offset. The model included fixed factors (treatment, country, stratification group) and a covariate (baseline HbA1c).||1.43|0.97|0.1079
70936882|NCT00321971|141373589|SUPERIORITY||Mean Difference (Final Values)|0.421|STANDARD_ERROR_OF_MEAN|0.11|<|0.05|TWO_SIDED|95.0|0.208|0.657|||Mixed Models Analysis|Intention-to-treat model|The CES-D data were log-transformed for analysis|Hypothesis: The experimental intervention group will endorse lower mean levels of depressive symptoms during follow-up than the study group receiving the comparison intervention.||0.657|0.208|<.05
70936883|NCT00813709|141373590|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.555||||0.002|TWO_SIDED|95.0|0.378|0.816|||Log Rank|||||0.816|0.378|0.002
70936884|NCT00813709|141373590|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.573||||0.006|TWO_SIDED|95.0|0.391|0.839|||Log Rank|||||0.839|0.391|0.006
70936885|NCT00813709|141373590|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.993||||0.941|TWO_SIDED|95.0|0.654|1.51|||Log Rank|||||1.510|0.654|0.941
70936886|NCT00813709|141373591|SUPERIORITY_OR_OTHER|||||||0.205||95.0|||||Log Rank|||||||0.205
70936887|NCT00813709|141373591|SUPERIORITY_OR_OTHER|||||||0.263||95.0|||||Log Rank|||||||0.263
70936888|NCT00813709|141373591|SUPERIORITY_OR_OTHER|||||||0.629||95.0|||||Log Rank|||||||0.629
70936889|NCT02753075|141373614|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.09||||0.829|TWO_SIDED|95.0|-0.289|0.461||For the Week 8 comparisons of two Oral Rinses against the Placebo Rinse, Dunnett's multiplicity adjustment is applied.|ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.461|-0.289|0.8290
71061928|NCT00380874|141632089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.62||0.4209||95.0|-1.77|0.76||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 9.||0.76|-1.77|0.4209
70936890|NCT02753075|141373614|SUPERIORITY_OR_OTHER||LS mean difference|-0.01||||0.9993|TWO_SIDED|95.0|-0.372|0.362||For the Week 8 comparisons of two Oral Rinses against the Placebo Rinse, Dunnett's multiplicity adjustment is applied.|ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.362|-0.372|0.9993
70936891|NCT02753075|141373615|SUPERIORITY_OR_OTHER||LS mean difference|0.09||||0.5892|TWO_SIDED|95.0|-0.242|0.424|||ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.424|-0.242|0.5892
70936892|NCT02753075|141373616|SUPERIORITY_OR_OTHER||LS mean difference|0.14||||0.2825|TWO_SIDED|95.0|-0.116|0.396|||ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.396|-0.116|0.2825
71061929|NCT00380874|141632089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.54||0.9657||95.0|-1.06|1.11||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Last Observation Carried Forward (LOCF)endpoint.||1.11|-1.06|0.9657
71061930|NCT00380874|141632090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.09||0.5392||95.0|-0.24|0.12|||ANCOVA|||Cycle 1.||0.12|-0.24|0.5392
71061931|NCT00380874|141632090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.22||0.5412||95.0|-0.3|0.57|||ANCOVA|||Cycle 2.||0.57|-0.30|0.5412
71061932|NCT00380874|141632090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.34||0.5358||95.0|-0.48|0.9|||ANCOVA|||Cycle 3.||0.90|-0.48|0.5358
71061933|NCT00380874|141632090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.41||0.4059||95.0|-0.48|1.17|||ANCOVA|||Cycle 4.||1.17|-0.48|0.4059
71061934|NCT00380874|141632090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|0.49||0.2712||95.0|-0.44|1.52|||ANCOVA|||Cycle 5.||1.52|-0.44|0.2712
71061935|NCT00380874|141632090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.38||0.9181||95.0|-0.81|0.73|||ANCOVA|||Cycle 6.||0.73|-0.81|0.9181
70936893|NCT02753075|141373616|SUPERIORITY_OR_OTHER||LS mean difference|0.03||||0.8448|TWO_SIDED|95.0|-0.229|0.28|||ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.280|-0.229|0.8448
70936894|NCT02753075|141373616|SUPERIORITY_OR_OTHER||LS mean difference|0.11||||0.3784|TWO_SIDED|95.0|-0.141|0.371|||ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.371|-0.141|0.3784
70941738|NCT04748445|141383935|OTHER||Slope|0.00007586|STANDARD_ERROR_OF_MEAN|2.882||0.979|TWO_SIDED|90.0|-0.004701|0.004852|||Mixed Models Analysis|||MM\_MFCC 1st order delta 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.004852|-0.004701|0.9790
71061936|NCT00380874|141632090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.42||0.4357||95.0|-0.52|1.17|||ANCOVA|||Cycle 7.||1.17|-0.52|0.4357
71061937|NCT00380874|141632090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.49||0.5103||95.0|-0.67|1.33|||ANCOVA|||||1.33|-0.67|0.5103
71061938|NCT00380874|141632090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.58||0.8499||95.0|-1.29|1.07|||ANCOVA|||Cycle 9.||1.07|-1.29|0.8499
71061939|NCT00380874|141632090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.39||0.7359||95.0|-0.9|0.64|||ANCOVA|||LOCF endpoint.||0.64|-0.90|0.7359
71061940|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.09||0.2034||95.0|-0.06|0.29|||ANCOVA|||Burning Spontaneous Pain Cycle 3||0.29|-0.06|0.2034
71061941|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.13||0.3062||95.0|-0.4|0.13|||ANCOVA|||Burning Spontaneous Pain Cycle 4||0.13|-0.40|0.3062
71061942|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.12||0.2787||95.0|-0.37|0.11|||ANCOVA|||Burning Spontaneous Pain Cycle 5||0.11|-0.37|0.2787
71061943|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.17||0.4124||95.0|-0.2|0.47|||ANCOVA|||Burning Spontaneous Pain Cycle 6||0.47|-0.20|0.4124
71061944|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.35||0.9541||95.0|-0.68|0.73|||ANCOVA|||Burning Spontaneous Pain Cycle 7||0.73|-0.68|0.9541
71061945|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.31||0.3383||95.0|-0.33|0.92|||ANOVA|||Burning Spontaneous Pain Cycle 8||0.92|-0.33|0.3383
71061946|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.39||0.8918||95.0|-0.84|0.74|||ANCOVA|||Burning Spontaneous Pain||0.74|-0.84|0.8918
71110284|NCT01118780|141726240|SUPERIORITY_OR_OTHER||LS mean difference|1.69|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|0.89|2.49||The p-value is for the change from baseline to Week 10 in the HADS Depression Subscale Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||2.49|0.89|<0.001
71110285|NCT01118780|141726241|SUPERIORITY_OR_OTHER||LS mean difference|0.53|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|0.26|0.79|||Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.79|0.26|<0.001
71061947|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.26||0.9614||95.0|-0.54|0.51|||ANCOVA|||Burning Spontaneous Pain LOCF endpoint||0.51|-0.54|0.9614
71061948|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.3022||95.0|-0.17|0.05|||ANCOVA|||Pressing Spontaneous Pain Cycle 2||0.05|-0.17|0.3022
71061949|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.04||0.3747||95.0|-0.04|0.12|||ANCOVA|||Pressing Spontaneous Pain Cycle 3||0.12|-0.04|0.3747
71061950|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.12||0.163||95.0|-0.4|0.07|||ANCOVA|||Pressing Spontaneous Pain Cycle 4||0.07|-0.40|0.1630
71061951|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.9568||95.0|-0.12|0.11|||ANOVA|||Pressing Spontaneous Pain Cycle 5||0.11|-0.12|0.9568
71061952|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.9793||95.0|-0.13|0.13|||ANCOVA|||Pressing Spontaneous Pain Cycle 6||0.13|-0.13|0.9793
71061953|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.25||0.885||95.0|-0.54|0.47|||ANCOVA|||Pressing Spontaneous Pain Cycle 7||0.47|-0.54|0.8850
71061954|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.21||0.2199||95.0|-0.17|0.7|||ANCOVA|||Pressing Spontaneous Pain Cycle 8||0.70|-0.17|0.2199
71061955|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.4017||95.0|-0.14|0.35|||ANCOVA|||Pressing Spontaneous Pain Cycle 9||0.35|-0.14|0.4017
71061956|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.09||0.4113||95.0|-0.1|0.24|||ANCOVA|||Pressing Spontaneous Pain LOCF Endpoint||0.24|-0.10|0.4113
71061957|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.3011||95.0|-0.06|0.02|||ANCOVA|||Paroxysmal Pain Cycle 3||0.02|-0.06|0.3011
71061958|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.1||0.4482||95.0|-0.26|0.12|||ANCOVA|||Paroxysmal Pain Cycle 4||0.12|-0.26|0.4482
71061959|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.1||0.3058||95.0|-0.31|0.1|||ANCOVA|||Paroxysmal Pain Cycle 5||0.10|-0.31|0.3058
71061960|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.12||0.3035||95.0|-0.38|0.12|||ANCOVA|||Paroxysmal Pain Cycle 6||0.12|-0.38|0.3035
71061961|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.23||0.9636||95.0|-0.46|0.48|||ANCOVA|||Paroxysmal Pain Cycle 7||0.48|-0.46|0.9636
71061962|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.35||0.366||95.0|-0.38|1.02|||ANCOVA|||Paroxysmal Pain Cycle 8||1.02|-0.38|0.3660
71061963|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.4093||95.0|-0.69|0.29|||ANCOVA|||Paroxysmal Pain Cycle 9||0.29|-0.69|0.4093
71110286|NCT01118780|141726242|SUPERIORITY_OR_OTHER||LS mean difference|0.62|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|0.33|0.91|||Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.91|0.33|<0.001
71110287|NCT01118780|141726243|SUPERIORITY_OR_OTHER||LS mean difference|0.55|STANDARD_ERROR_OF_MEAN|0.29||0.059|TWO_SIDED|95.0|-0.02|1.11||The p-value is for the change from baseline to Week 10 in BPI-SF Worst Pain Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.11|-0.02|0.059
70936895|NCT02753075|141373617|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.1688|TWO_SIDED|95.0|-10.0|0.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. Median Difference has been calculated from non-parametric Hodges-Lehmann estimations.|||0.000|-10.00|0.1688
71061964|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.5208||95.0|-0.39|0.2|||ANCOVA|||Paroxysmal Pain LOCF Endpoint||0.20|-0.39|0.5208
71061965|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.9931||95.0|-0.17|0.17|||ANCOVA|||Evoke Pain Cycle 2||0.17|-0.17|0.9931
71061966|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.17||0.5867||95.0|-0.25|0.44|||ANCOVA|||Evoke Pain Cycle 3||0.44|-0.25|0.5867
71061967|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.12||0.2748||95.0|-0.37|0.11|||ANCOVA|||Evoke Pain Cycle 4||0.11|-0.37|0.2748
71061968|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.2||0.5521||95.0|-0.51|0.28|||ANCOVA|||Evoke Pain Cycle 5||0.28|-0.51|0.5521
71061969|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.39||0.6734||95.0|-0.96|0.62|||ANCOVA|||Evoke Pain Cycle 6||0.62|-0.96|0.6734
71061970|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.37||0.1214||95.0|-0.16|1.33|||ANCOVA|||Evoke Pain Cycle 7||1.33|-0.16|0.1214
71061971|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.51||0.1845||95.0|-0.34|1.72|||ANCOVA|||Evoke Pain Cycle 8||1.72|-0.34|0.1845
71061972|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.37||0.6863||95.0|-0.6|0.9|||ANCOVA|||Evoke Pain Cycle 9||0.90|-0.60|0.6863
71061973|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.27||0.9273||95.0|-0.51|0.56|||ANCOVA|||Evoke Pain LOCF Endpoint||0.56|-0.51|0.9273
71061974|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.12||0.0416||95.0|0.01|0.5|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 2||0.50|0.01|0.0416
71110288|NCT01118780|141726243|SUPERIORITY_OR_OTHER||LS mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.24||0.079|TWO_SIDED|95.0|-0.05|0.89||The p-value is for the change from baseline to Week 10 in BPI-SF Least Pain Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.89|-0.05|0.079
71110289|NCT01118780|141726243|SUPERIORITY_OR_OTHER||LS mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.25||0.089|TWO_SIDED|95.0|-0.06|0.91||The p-value is for the change from baseline to Week 10 in BPI-SF Average Pain Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.91|-0.06|0.089
71110290|NCT01118780|141726243|SUPERIORITY_OR_OTHER||LS mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.25||0.371|TWO_SIDED|95.0|-0.27|0.73||The p-value is for the change from baseline to Week 10 in BPI-SF Pain Right Now Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.73|-0.27|0.371
71110291|NCT01118780|141726243|SUPERIORITY_OR_OTHER||LS mean difference|0.53|STANDARD_ERROR_OF_MEAN|0.29||0.066|TWO_SIDED|95.0|-0.04|1.09||The p-value is for the change from baseline to Week 10 in BPI-SF General Activity Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.09|-0.04|0.066
71110292|NCT01118780|141726243|SUPERIORITY_OR_OTHER||LS mean difference|0.41|STANDARD_ERROR_OF_MEAN|0.27||0.14|TWO_SIDED|95.0|-0.13|0.95||The p-value is for the change from baseline to Week 10 in BPI-SF Mood Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.95|-0.13|0.140
70936896|NCT02753075|141373617|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.438|TWO_SIDED|95.0|-5.0|0.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. Median Difference has been calculated from non-parametric Hodges-Lehmann estimations.|||0.000|-5.000|0.4380
71061975|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.15||0.1819||95.0|-0.1|0.5|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 3||0.50|-0.10|0.1819
71061976|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.17||0.0331||95.0|0.03|0.7|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 4||0.70|0.03|0.0331
71061977|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0608||95.0|-0.02|0.83|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 5||0.83|-0.02|0.0608
71061978|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.33||0.2809||95.0|-0.31|1.03|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 6||1.03|-0.31|0.2809
71061979|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.32||0.3445||95.0|-0.34|0.95|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 7||0.95|-0.34|0.3445
71061980|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.47||0.2806||95.0|-0.44|1.46|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 8||1.46|-0.44|0.2806
71061981|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.49||0.5217||95.0|-0.68|1.33|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 9||1.33|-0.68|0.5217
71061982|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.34||0.3628||95.0|-0.37|1.0|||ANCOVA|||Parethesia/Dysesthesia Pain LOCF Endpoint||1.00|-0.37|0.3628
71061983|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.3557||95.0|0.0|0.01|||ANCOVA|||Total Score Cycle 2||0.01|-0.00|0.3557
71061984|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.2824||95.0|0.0|0.01|||ANCOVA|||Total Score Cycle 3||0.01|-0.00|0.2824
71061985|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.5931||95.0|-0.01|0.01|||ANCOVA|||Total Score Cycle 4||0.01|-0.01|0.5931
70936897|NCT02753075|141373617|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.5693|TWO_SIDED|95.0|-5.0|0.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. Median Difference has been calculated from non-parametric Hodges-Lehmann estimations.|||0.000|-5.000|0.5693
70936898|NCT02753075|141373618|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.7789|TWO_SIDED|95.0|-5.0|0.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||0.000|-5.000|0.7789
70936899|NCT02753075|141373618|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.7214|TWO_SIDED|95.0|-5.0|0.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||0.000|-5.000|0.7214
70936900|NCT02753075|141373618|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.896|TWO_SIDED|95.0|-5.0|5.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||5.000|-5.000|0.8960
71061986|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.9865||95.0|-0.01|0.01|||ANCOVA|||Total Score Cycle 5||0.01|-0.01|0.9865
70936901|NCT02753075|141373619|SUPERIORITY_OR_OTHER||LS mean difference|0.45||||0.0978|TWO_SIDED|95.0|-0.084|0.987|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.987|-0.084|0.0978
70936902|NCT02753075|141373619|SUPERIORITY_OR_OTHER||LS mean difference|0.2||||0.4607|TWO_SIDED|95.0|-0.333|0.732|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.732|-0.333|0.4607
70936903|NCT02753075|141373619|SUPERIORITY_OR_OTHER||LS mean difference|0.25||||0.3542|TWO_SIDED|95.0|-0.283|0.787|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.787|-0.283|0.3542
71061987|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.9854||95.0|-0.02|0.02|||ANCOVA|||Total Score Cycle 6||0.02|-0.02|0.9854
71061988|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.01||0.3403||95.0|-0.01|0.04|||ANCOVA|||Total Score Cycle 7||0.04|-0.01|0.3403
71061989|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.2226||95.0|-0.01|0.05|||ANCOVA|||Total Score Cycle 8||0.05|-0.01|0.2226
71061990|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.9694||95.0|-0.03|0.03|||ANCOVA|||Total Score Cycle 9||0.03|-0.03|0.9694
71061991|NCT00380874|141632091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.8957||95.0|-0.02|0.02|||ANCOVA|||Total Score LOCF Endpoint||0.02|-0.02|0.8957
71061992|NCT00380874|141632093|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.49||0.7489||95.0||||No multiple comparisons adjustment was necessary.|ANCOVA|Model terms include treatment, study center, and baseline score.|Least squares (LS) means and corresponding standard errors derived from ANCOVA model were used.|LOCF cycle endpoint. Sample size based on original primary efficacy parameter (PEP) of time to persistent symptoms (developing in 35% of pregabalin subjects \& 60% of placebo subjects). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, study would have had at least 90% power using 100 subjects per treatment group. Original PEP was modified to secondary due to lack of persistent paresthetic symptom emergence.||||0.7489
71061993|NCT01451463|141632114|SUPERIORITY_OR_OTHER|||||||0.009|||||||t-test, 2 sided|||||||.009
71061994|NCT01451463|141632115|SUPERIORITY_OR_OTHER|||||||0.114|||||||t-test, 2 sided|||||||.114
71061995|NCT05479435|141632179|OTHER|||||||0.83|||||||Kruskal-Wallis|||||||0.830
71061996|NCT05479435|141632180|OTHER|||||||0.654|||||||ANCOVA|||||||0.654
71061997|NCT05479435|141632181|OTHER|||||||0.803|||||||ANCOVA|||||||0.803
71061998|NCT05479435|141632182|OTHER|||||||0.398|||||||ANCOVA|||||||0.398
71061999|NCT05479435|141632183|OTHER|||||||0.132|||||||Kruskal-Wallis|||||||0.132
71062000|NCT05479435|141632184|OTHER|||||||0.991|||||||Kruskal-Wallis|||||||0.991
71062001|NCT05479435|141632185|OTHER|||||||0.278|||||||Kruskal-Wallis|||||||0.278
71062002|NCT05479435|141632186|OTHER|||||||0.479|||||||ANCOVA|||||||0.479
71062003|NCT05479435|141632187|OTHER|||||||0.849|||||||Kruskal-Wallis|||||||0.849
71062004|NCT05479435|141632188|OTHER|||||||0.504|||||||Kruskal-Wallis|||||||0.504
70936904|NCT02753075|141373620|SUPERIORITY_OR_OTHER||LS mean difference|0.02||||0.9474|TWO_SIDED|95.0|-0.665|0.711|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.711|-0.665|0.9474
70936905|NCT02753075|141373620|SUPERIORITY_OR_OTHER||LS mean difference|-0.09||||0.7987|TWO_SIDED|95.0|-0.76|0.586|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.586|-0.760|0.7987
71062005|NCT05479435|141632189|OTHER|||||||0.017|||||||ANCOVA|||||||0.017
71062006|NCT05479435|141632190|OTHER|||||||0.025|||||||Kruskal-Wallis|||||||0.025
71062007|NCT05479435|141632191|OTHER|||||||0.016|||||||ANCOVA|||||||0.016
71062008|NCT05479435|141632192|OTHER|||||||0.041|||||||ANCOVA|||||||0.041
71062009|NCT05479435|141632193|OTHER|||||||0.352|||||||Kruskal-Wallis|||||||0.352
71062010|NCT05479435|141632194|OTHER|||||||0.39|||||||Kruskal-Wallis|||||||0.390
71062011|NCT05479435|141632195|OTHER|||||||0.928|||||||ANCOVA|||||||0.928
71062012|NCT05479435|141632196|OTHER|||||||0.558|||||||Kruskal-Wallis|||||||0.558
71062013|NCT05479435|141632197|OTHER|||||||0.133|||||||Kruskal-Wallis|||||||0.133
71062014|NCT05479435|141632198|OTHER|||||||0.367|||||||Kruskal-Wallis|||||||0.367
71062015|NCT05479435|141632199|OTHER|||||||0.631|||||||ANCOVA|||||||0.631
71062016|NCT05479435|141632200|OTHER|||||||0.056|||||||ANCOVA|||||||0.056
71062017|NCT05479435|141632201|OTHER|||||||0.979|||||||ANCOVA|||||||0.979
71062018|NCT05479435|141632202|OTHER|||||||0.377|||||||ANCOVA|||||||0.377
71062019|NCT05479435|141632203|OTHER|||||||0.979|||||||ANCOVA|||||||0.979
71062020|NCT05479435|141632204|OTHER|||||||0.055|||||||ANCOVA|||||||0.055
71062021|NCT05016960|141632265|OTHER|one group paired samples t test to compare scores at pre vs. post treatment||||||0.503|||||||t-test, 2 sided|||||||.503
71062022|NCT05016960|141632266|NON_INFERIORITY|one group paired samples t test||||||0.23|||||||t-test, 2 sided|||||||.230
71062023|NCT05016960|141632267|OTHER|one group paired samples t test||||||0.061|||||||t-test, 2 sided|||||||.061
71062024|NCT05016960|141632268|OTHER|one group paired samples t test|||||<|0.001|||||||t-test, 2 sided|||||||<.001
71062025|NCT05016960|141632269|OTHER|one group paired samples t test||||||0.01|||||||t-test, 2 sided|||||||.01
71062026|NCT05016960|141632270|OTHER|one group paired samples t test||||||0.625|||||||t-test, 2 sided|||||||.625
71062027|NCT05016960|141632271|OTHER|one group paired samples t test||||||0.134|||||||t-test, 2 sided|||||||.134
71062028|NCT05016960|141632272|OTHER|one group paired samples t test||||||0.515|||||||t-test, 2 sided|||||||.515
71062029|NCT05016960|141632273|OTHER|one group paired samples t test||||||0.41|||||||t-test, 2 sided|||||||.410
71062030|NCT05016960|141632274|OTHER|one group paired samples t test||||||0.706|||||||t-test, 2 sided|||||||.706
71062031|NCT05016960|141632275|OTHER|one group paired samples t test||||||0.062|||||||t-test, 2 sided|||||||.062
71062032|NCT05016960|141632276|OTHER|one group paired samples t test||||||0.39|||||||t-test, 2 sided|||||||.390
71062033|NCT05016960|141632277|OTHER|one group paired samples t test||||||0.38|||||||t-test, 2 sided|||||||.38
71062034|NCT05016960|141632278|OTHER|One group paired samples t test||||||0.064|||||||t-test, 2 sided|||||||.064
71062035|NCT04796961|141632279|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|0.1|0.7||||||||0.7|0.1|
71062036|NCT04796961|141632280|SUPERIORITY||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|-0.1|1.1||||||smoking screening||1.1|-0.1|
71062037|NCT04796961|141632280|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|95.0|-0.1|1.2||||||readiness to quit assessments||1.2|-0.1|
71062038|NCT04796961|141632280|SUPERIORITY||Mean Difference (Net)|1.4|||||TWO_SIDED|95.0|0.8|2.0||||||smoking cessation counseling||2.0|0.8|
71062039|NCT04796961|141632280|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|95.0|-0.5|1.7||||||smoking cessation pharmacotherapy||1.7|-0.5|
71062040|NCT02218463|141632292|SUPERIORITY|||||||0.206|||||||Fisher Exact|||Assessment of complete resolution between the 2 study arms.||||0.206
71062041|NCT02218463|141632293|SUPERIORITY|||||||0.0001|||||||ANOVA|||Time Effect||||0.0001
71062042|NCT02218463|141632293|SUPERIORITY|||||||0.37|||||||ANOVA|||Treatment Effect||||0.370
71062043|NCT02218463|141632293|SUPERIORITY|||||||0.425|||||||ANOVA|||Treatment by time interaction||||0.425
71062044|NCT02513160|141632305|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|150.0|||<|0.0001|TWO_SIDED|95.0|86.8|213.2||a priori threshold for significance of 0.05.|ANCOVA|Difference of LS means, 95% CI, and p-value represent ANCOVA results adjusted for baseline, sex, age, current asthma therapy, and treatment.|Active - placebo|A fixed-sequence multiple testing procedure was implemented to interpret the results from the primary analysis while controlling the family-wise error rate at 5%. The 640-mcg/day BAI dose was tested first. If the comparison to placebo resulted in p≤0.05, the 320-mcg/day BAI dose was then tested.||213.2|86.8|<0.0001
71062045|NCT02513160|141632305|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|144.0|||<|0.0001|TWO_SIDED|95.0|80.7|206.6||a priori threshold for significance of 0.05.|ANCOVA|Difference of LS means, 95% CI, and p-value represent ANCOVA results adjusted for baseline, sex, age, current asthma therapy, and treatment.|Active - placebo|A fixed-sequence multiple testing procedure was implemented to interpret the results from the primary analysis while controlling the family-wise error rate at 5%. The 640-mcg/day BAI dose was tested first. If the comparison to placebo resulted in p≤0.05, the 320-mcg/day BAI dose was then tested.||206.6|80.7|<0.0001
71062046|NCT02513160|141632305|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|148.0|||<|0.0001|TWO_SIDED|95.0|84.7|211.4||a priori threshold for significance of 0.05. The p-value was not adjusted.|ANCOVA|Difference of LS means and 95% CI represent ANCOVA results adjusted for baseline, sex, age, current asthma therapy, and treatment.|Active - placebo|||211.4|84.7|<0.0001
71078025|NCT01026818|141664566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.704|TWO_SIDED|95.0|0.48|1.65||The Type I error was controlled for multiplicity using a Bonferroni-Hommel procedure. First the largest p-value for the odds ratio to placebo was tested at the 5% level and in case of no rejection the second p-value was tested at the 2.5% level.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.||A sample size of 412 randomized participants provided 84% power to detect a 20% difference in the proportions for the 3 treatment groups. The sample size allowed for a 20% withdrawal during the study.||1.65|0.48|0.704
71078026|NCT01026818|141664567|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.15||||0.016|TWO_SIDED|95.0|1.16|3.99||P-value is for Month 9.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.||||3.99|1.16|0.016
71078027|NCT01026818|141664567|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.21|TWO_SIDED|95.0|0.79|2.85||P-value is for Month 9.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.||||2.85|0.79|0.210
71078028|NCT01026818|141664567|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.273|TWO_SIDED|95.0|0.79|2.28||P-value is for Month 13.5.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.||||2.28|0.79|0.273
71078029|NCT01026818|141664567|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.259|TWO_SIDED|95.0|0.8|2.29||P-value is for Month 13.5.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.||||2.29|0.80|0.259
71062047|NCT02513160|141632306|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|21.9||||0.0003|TWO_SIDED|95.0|10.11|33.71||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Treatment comparisons began with am PEF for BAI 640 mcg/day vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BAI 640 mcg/day vs placebo 2) the am PEF for BAI 320 mcg/day vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||33.71|10.11|0.0003
71062048|NCT02513160|141632306|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|30.1|||<|0.0001|TWO_SIDED|95.0|18.33|41.9||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in previous analysis.||41.90|18.33|<0.0001
71062049|NCT02513160|141632306|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|21.0||||0.0006|TWO_SIDED|95.0|9.14|32.83||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Comparisons for MDI dose versus placebo for the secondary efficacy endpoints were used for assay sensitivity.||32.83|9.14|0.0006
71062050|NCT02513160|141632307|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|143.0|||<|0.0001|TWO_SIDED|95.0|71.7|214.1||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.||214.1|71.7|<0.0001
71062051|NCT02513160|141632307|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|170.0|||<|0.0001|TWO_SIDED|95.0|98.5|240.5||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.||240.5|98.5|<0.0001
71062052|NCT02513160|141632307|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|133.0||||0.0003|TWO_SIDED|95.0|61.3|204.3||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Comparisons for MDI dose versus placebo for the secondary efficacy endpoints were used for assay sensitivity.||204.3|61.3|0.0003
71062053|NCT02513160|141632308|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.408|-0.64||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.||-0.640|-1.408|<0.0001
71062054|NCT02513160|141632308|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.482|-0.717||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.||-0.717|-1.482|<0.0001
71062055|NCT02513160|141632308|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-1.03|||<|0.0001|TWO_SIDED|95.0|-1.415|-0.643||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Comparisons for MDI dose versus placebo for the secondary efficacy endpoints were used for assay sensitivity.||-0.643|-1.415|<0.0001
71062056|NCT02513160|141632309|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.32|||<|0.0001|TWO_SIDED|95.0|-0.44|-0.203||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.||-0.203|-0.440|<0.0001
71062057|NCT02513160|141632309|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.25|||<|0.0001|TWO_SIDED|95.0|-0.365|-0.128||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.||-0.128|-0.365|<0.0001
70936906|NCT02753075|141373620|SUPERIORITY_OR_OTHER||LS mean difference|0.11||||0.7525|TWO_SIDED|95.0|-0.578|0.798|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.798|-0.578|0.7525
71078030|NCT01026818|141664568|SUPERIORITY_OR_OTHER||LS Mean Differences|2.8|STANDARD_ERROR_OF_MEAN|1.03||0.007|TWO_SIDED|95.0|0.76|4.83||P-value is for Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||4.83|0.76|0.007
71078031|NCT01026818|141664568|SUPERIORITY_OR_OTHER||LS Mean differences|1.59|STANDARD_ERROR_OF_MEAN|1.02||0.118|TWO_SIDED|95.0|-0.41|3.6||P-value is for Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||3.60|-0.41|0.118
71078032|NCT01026818|141664568|SUPERIORITY_OR_OTHER||LS Mean Differences|0.26|STANDARD_ERROR_OF_MEAN|1.04||0.802|TWO_SIDED|95.0|-1.79|2.31||P-value is for Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.31|-1.79|0.802
71078033|NCT01026818|141664568|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.22|STANDARD_ERROR_OF_MEAN|1.02||0.83|TWO_SIDED|95.0|-2.23|1.79||P-value is for Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.79|-2.23|0.830
71078034|NCT01026818|141664568|SUPERIORITY_OR_OTHER||LS Mean Differences|1.62|STANDARD_ERROR_OF_MEAN|1.22||0.184|TWO_SIDED|95.0|-0.78|4.03||P-value is for Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||4.03|-0.78|0.184
71062058|NCT02513160|141632309|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.3|||<|0.0001|TWO_SIDED|95.0|-0.423|-0.185||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Comparisons for MDI dose versus placebo for the secondary efficacy endpoints were used for assay sensitivity.||-0.185|-0.423|<0.0001
71062059|NCT02513160|141632310|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0058|||||||Log Rank|||||||0.0058
71062060|NCT02513160|141632310|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014|||||||Log Rank|||||||0.0014
71062061|NCT02513160|141632310|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0062|||||||Log Rank|||||||0.0062
71062062|NCT03851406|141632396|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||||||> 0.99
71062063|NCT03851406|141632397|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||||||> 0.99
71062064|NCT03851406|141632398|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||> 0.99
71062065|NCT03851406|141632398|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||> 0.99
71062066|NCT03851406|141632399|OTHER|||||||0.38||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.38
71062067|NCT03851406|141632399|OTHER|||||||0.38||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.38
71062068|NCT03851406|141632400|OTHER|||||||0.25||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.25
71062069|NCT03851406|141632400|OTHER|||||||0.63||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.63
71062070|NCT03851406|141632401|OTHER|||||||0.88||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.88
71062071|NCT03851406|141632401|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||>0.99
71062072|NCT03851406|141632402|OTHER|||||||0.88||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.88
71062073|NCT03851406|141632402|OTHER|||||||0.25||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.25
71062074|NCT03851406|141632403|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||>0.99
71062075|NCT03851406|141632403|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||>0.99
71062076|NCT03851406|141632404|OTHER|||||||0.75||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.75
71062077|NCT03851406|141632404|OTHER|||||||0.38||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.38
71062078|NCT03511105|141632432|OTHER||Absolute Difference|-30.46|STANDARD_ERROR_OF_MEAN|48.662|||TWO_SIDED|95.0|-127.07|65.51|||||Absolute difference (GSK2798745 - Placebo) and 95% CrI has been presented.|||65.51|-127.07|
71062079|NCT03511105|141632432|OTHER||Percentage change|8.73|STANDARD_ERROR_OF_MEAN|13.453|||TWO_SIDED|95.0|-21.41|31.3|||||Percentage change on GSK2798745 relative to placebo has been presented.|||31.30|-21.41|
71062080|NCT03511105|141632433|OTHER||Absolute Difference|-4.26|STANDARD_ERROR_OF_MEAN|13.679|||TWO_SIDED|95.0|-31.49|22.87|||||Absolute difference (GSK2798745 - Placebo) and 95% CrI have been presented.|||22.87|-31.49|
70936907|NCT01102426|141373625|SUPERIORITY||Hazard Ratio (HR)|0.65|||=|0.0054|TWO_SIDED|95.0|0.447|0.885||Cox regression: HR p=0.0062|Log Rank|||||0.885|0.447|=0.0054
71062081|NCT03511105|141632433|OTHER||Percentage change|7.31|STANDARD_ERROR_OF_MEAN|22.837|||TWO_SIDED|95.0|-48.2|41.64|||||Percentage change on GSK2798745 relative to placebo has been presented.|||41.64|-48.20|
71062082|NCT03511105|141632434|OTHER||Absolute Difference|-0.06|STANDARD_ERROR_OF_MEAN|3.178|||TWO_SIDED|95.0|-6.28|6.2|||||Absolute difference (GSK2798745 - Placebo) and 95% CrI have been presented.|||6.20|-6.28|
71062083|NCT03511105|141632434|OTHER||Percentage change|0.1|STANDARD_ERROR_OF_MEAN|5.429|||TWO_SIDED|95.0|-11.15|10.16|||||Percentage change on GSK2798745 relative to placebo has been presented.|||10.16|-11.15|
71062084|NCT02810457|141632458|EQUIVALENCE|A 90% CI for the ORR ratio between FKB238 and Avastin was estimated and compared to the margin (0.73 to 1.38), which was deemed to represent a clinically acceptable difference with respect to ORR. If the 90% CI was within the equivalence margin (0.73 to 1.38), an equivalence between FKB238 and Avastin, with respect to the ORR, was confirmed.|Ratio in ORR|0.96|||||TWO_SIDED|90.0|0.86|1.08||||||||1.08|0.86|
71062085|NCT02810457|141632459|OTHER|Ratio in ORR analysis of FKB238 versus Avastin.|Ratio in ORR|0.94|||||TWO_SIDED|90.0|0.83|1.06||||||Comparison between groups: Risk ratio in ORR at Week 19 by BICR.||1.06|0.83|
71062086|NCT02810457|141632460|OTHER|Hazard ratio analysis of FKB238 versus Avastin.|Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.82|1.16|||||Treatment hazard ratio \<1 favors FKB238.|Hazard ratio and its 95% CI were calculated using the Cox regression model adjusting for baseline characteristics (randomization stratification factors, Eastern Cooperative Oncology Group (ECOG) performance status at baseline, gender, smoking history and age) with ties handled by the Efron method.||1.16|0.82|
71062087|NCT02810457|141632461|OTHER|Hazard ratio analysis of FKB238 versus Avastin.|Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.96|1.45|||||Treatment hazard ratio \<1 favors FKB238.|Hazard ratio and its 95% CI were calculated using the Cox regression model adjusting for baseline characteristics (randomization stratification factors, ECOG performance status at baseline, gender, smoking history and age) with ties handled by the Efron method.||1.45|0.96|
71062088|NCT02810457|141632462|OTHER|Hazard ratio analysis of FKB238 versus Avastin.|Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.74|1.23|||||Treatment hazard ratio \<1 favors FKB238.|Hazard ratio and its 95% CI were calculated using the Cox regression model adjusting for baseline characteristics (randomization stratification factors, ECOG performance status at baseline, gender, smoking history and age) with ties handled by the Efron method.||1.23|0.74|
70936908|NCT01102426|141373626|SUPERIORITY|||||||0.0618|||||||Normal approximation|||||||0.0618
70936909|NCT01102426|141373627|SUPERIORITY||Hazard Ratio (HR)|0.512|||<|0.0001|TWO_SIDED|95.0|0.382|0.686||Cox regression HR: p\<0.0001|Log Rank|||||0.686|0.382|< 0.0001
70936910|NCT01102426|141373628|SUPERIORITY|||||||0.0002|||||||Normal approximation|||||||0.0002
70936911|NCT01102426|141373629|SUPERIORITY||Hazard Ratio (HR)|0.797|||=|0.1261|TWO_SIDED|95.0|0.596|1.067||Cox regression HR: p=0.1273|Log Rank|||Pre-specified||1.067|0.596|=0.1261
70936912|NCT01102426|141373630|SUPERIORITY|||||||0.3625|||||||Normal approximation|||||||0.3625
70936913|NCT01102426|141373631|SUPERIORITY|||||||0.1037|||||||Normal approximation|||||||0.1037
70936914|NCT01102426|141373632|SUPERIORITY||Hazard Ratio (HR)|0.384|||=|0.1015|TWO_SIDED|95.0|0.113|1.303||Cox regression HR: 0.1247|Log Rank|||||1.303|0.113|=0.1015
70936915|NCT01102426|141373634|SUPERIORITY||Hazard Ratio (HR)|0.043|||=|0.0001|TWO_SIDED|95.0|0.004|0.479||Cox regression HR: 0.0105|Log Rank|||Pre-specified||0.479|0.004|=0.0001
70936916|NCT01102426|141373637|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
70936917|NCT01102426|141373638|SUPERIORITY|||||||0.0085|||||||Fisher Exact|||||||0.0085
70936918|NCT01102426|141373640|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71062089|NCT02810457|141632463|OTHER|Comparison between arms: Odds ratio.|Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.64|1.58|||||Odds ratio \>1 favors FKB238.|The DCR was compared between treatment arms using logistic regression adjusting for baseline characteristics (randomization stratification factors, ECOG performance status at baseline, gender, smoking history and age).||1.58|0.64|
71062090|NCT04231825|141632483|SUPERIORITY|||||||0.55|||||||ANCOVA|||||||0.55
71062091|NCT04231825|141632484|SUPERIORITY|||||||0.51|||||||ANCOVA|||||||0.51
71110293|NCT01118780|141726243|SUPERIORITY_OR_OTHER||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.29||0.04|TWO_SIDED|95.0|0.03|1.18||The p-value is for the change from baseline to Week 10 in BPI-SF Walking Ability Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.18|0.03|0.040
70936919|NCT01102426|141373641|SUPERIORITY|||||||0.0029|||||||Fisher Exact|||||||0.0029
70936920|NCT01918033|141373665|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares (LS) Means|-0.09||||0.661|TWO_SIDED|95.0|-0.49|0.31|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Week 2|||0.31|-0.49|0.661
70936921|NCT01918033|141373665|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.08||||0.707|TWO_SIDED|95.0|-0.48|0.32|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Week 2|||0.32|-0.48|0.707
70936922|NCT01918033|141373668|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.48||||0.01|TWO_SIDED|95.0|-0.84|-0.11|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Day 3|||-0.11|-0.84|0.010
70936923|NCT01918033|141373668|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.46||||0.013|TWO_SIDED|95.0|-0.82|-0.1|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Day 3|||-0.10|-0.82|0.013
70936924|NCT01918033|141373668|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.12||||0.569|TWO_SIDED|95.0|-0.29|0.53|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Week 1|||0.53|-0.29|0.569
70936925|NCT01918033|141373668|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.09||||0.685|TWO_SIDED|95.0|-0.33|0.5|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Week 1|||0.50|-0.33|0.685
70936926|NCT01918033|141373669|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.547|TWO_SIDED|95.0|-0.15|0.08|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Sneezing Nasal Symptom Sub-Score at Week 2|||0.08|-0.15|0.547
70936927|NCT01918033|141373669|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.1||||0.067|TWO_SIDED|95.0|-0.22|0.01|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Sneezing Nasal Symptom Sub-Score at Week 2|||0.01|-0.22|0.067
70936928|NCT01918033|141373669|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.01||||0.895|TWO_SIDED|95.0|-0.15|0.13|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Rhinorrhea Nasal Symptom Sub-Score at Week 2|||0.13|-0.15|0.895
71062092|NCT04231825|141632485|SUPERIORITY|||||||0.8|||||||ANCOVA|||||||0.80
71062093|NCT04231825|141632486|SUPERIORITY|||||||0.02|||||||ANCOVA|||||||0.02
71062094|NCT04231825|141632487|SUPERIORITY|||||||0.03|||||||ANCOVA|||||||0.03
71062095|NCT02019472|141632488|SUPERIORITY_OR_OTHER||LS mean difference|-0.76|||<|0.001|TWO_SIDED|95.0|-1.07|-0.46|||ANCOVA|||||-0.46|-1.07|< 0.001
71062096|NCT02019472|141632488|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.39|||=|0.013|TWO_SIDED|95.0|-0.69|-0.08|||ANCOVA|||||-0.08|-0.69|=0.013
71062097|NCT02019472|141632489|SUPERIORITY_OR_OTHER||Percentage Difference|-4.8||||0.306|TWO_SIDED|95.0|-14.1|4.4|||Cochran-Mantel-Haenszel|||||4.4|-14.1|0.306
71062098|NCT02019472|141632489|SUPERIORITY_OR_OTHER||Percentage Difference|3.6||||0.464|TWO_SIDED|95.0|-6.0|13.1|||Cochran-Mantel-Haenszel|||||13.1|-6|0.464
71062099|NCT02019472|141632490|SUPERIORITY_OR_OTHER||Percentage Difference|5.4||||0.086|TWO_SIDED|95.0|-0.7|11.4|||Cochran-Mantel-Haenszel|||||11.4|-0.7|0.086
71062100|NCT02019472|141632490|SUPERIORITY_OR_OTHER||Percentage Difference|12.8|||<|0.001|TWO_SIDED|95.0|5.9|19.7|||Cochran-Mantel-Haenszel|||||19.7|5.9|< 0.001
71062101|NCT02019472|141632491|SUPERIORITY_OR_OTHER||Percentage Difference|-2.7||||0.603|TWO_SIDED|95.0|-12.8|7.4|||Cochran-Mantel-Haenszel|||||7.4|-12.8|0.603
71062102|NCT02019472|141632491|SUPERIORITY_OR_OTHER||Percentage Difference|2.4||||0.644|TWO_SIDED|95.0|-7.6|12.3|||Cochran-Mantel-Haenszel|||||12.3|-7.6|0.644
71062103|NCT03861390|141632492|OTHER|||||||0.24||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||||||0.24
71062104|NCT03861390|141632493|OTHER|||||||0.17||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||||||0.17
71062105|NCT03861390|141632494|OTHER|||||||0.7||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.70
71062106|NCT03861390|141632494|OTHER|||||||0.37||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.37
71062107|NCT03861390|141632495|OTHER|||||||0.77||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.77
71062108|NCT03861390|141632495|OTHER|||||||0.48||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.48
71062109|NCT03861390|141632496|OTHER|||||||0.96||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.96
71062110|NCT03861390|141632496|OTHER|||||||0.91||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.91
71062111|NCT03861390|141632497|OTHER|||||||0.46||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.46
71062112|NCT03861390|141632497|OTHER|||||||0.46||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.46
71062113|NCT03861390|141632498|OTHER|||||||0.82||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.82
71062114|NCT03861390|141632498|OTHER|The a priori threshold for statistical significance is \< 0.05.||||||0.99|||||||Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.99
70936929|NCT01918033|141373669|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.03||||0.627|TWO_SIDED|95.0|-0.1|0.17|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Rhinorrhea Nasal Symptom Sub-Score at Week 2|||0.17|-0.10|0.627
71062115|NCT03861390|141632499|OTHER|||||||0.38||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.38
71062116|NCT03861390|141632499|OTHER|||||||0.84||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.84
71062117|NCT03861390|141632500|OTHER|||||||0.49||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.49
71062118|NCT03861390|141632500|OTHER|||||||0.52||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.52
71062119|NCT01217112|141632502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.044||0.766|TWO_SIDED|90.0|-0.09|0.06|||ANCOVA|||Data was analysed by analysis of covariance (ANCOVA). The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.06|-0.09|0.766
71110294|NCT01118780|141726243|SUPERIORITY_OR_OTHER||LS mean difference|0.38|STANDARD_ERROR_OF_MEAN|0.29||0.187|TWO_SIDED|95.0|-0.19|0.94||The p-value is for the change from baseline to Week 10 in BPI-SF Normal Work Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.94|-0.19|0.187
71062120|NCT01217112|141632502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.043||0.424|TWO_SIDED|90.0|-0.04|0.11|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.11|-0.04|0.424
71062121|NCT01217112|141632502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.041||0.412|TWO_SIDED|90.0|-0.1|0.04|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.04|-0.10|0.412
71062122|NCT01217112|141632502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.043||0.668|TWO_SIDED|90.0|-0.05|0.09|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.09|-0.05|0.668
71062123|NCT01217112|141632503|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.046||0.978|TWO_SIDED|90.0|-0.08|0.08|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.08|-0.08|0.978
71062124|NCT01217112|141632503|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.045||0.864|TWO_SIDED|90.0|-0.08|0.07|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.07|-0.08|0.864
71062125|NCT01217112|141632503|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.05||0.537|TWO_SIDED|90.0|-0.12|0.05|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.05|-0.12|0.537
71062126|NCT01217112|141632503|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.045||0.26|TWO_SIDED|90.0|-0.02|0.13|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.13|-0.02|0.260
71062127|NCT01217112|141632504|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.18||0.088|TWO_SIDED|90.0|-0.61|-0.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||-0.01|-0.61|0.088
70936930|NCT01918033|141373669|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.04||||0.535|TWO_SIDED|95.0|-0.09|0.18|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Nasal Congestion Nasal Symptom Sub-Score at Week 2|||0.18|-0.09|0.535
71062128|NCT01217112|141632504|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.177||0.583|TWO_SIDED|90.0|-0.2|0.39|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.39|-0.20|0.583
71062129|NCT01217112|141632504|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.169||0.388|TWO_SIDED|90.0|-0.14|0.43|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.43|-0.14|0.388
71062130|NCT01217112|141632504|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.17||0.58|TWO_SIDED|90.0|-0.19|0.38|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.38|-0.19|0.580
71062131|NCT01217112|141632505|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.198||0.829|TWO_SIDED|90.0|-0.29|0.37|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.37|-0.29|0.829
71062132|NCT01217112|141632505|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.196||0.575|TWO_SIDED|90.0|-0.22|0.44|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.44|-0.22|0.575
71062133|NCT01217112|141632505|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.203||0.356|TWO_SIDED|90.0|-0.15|0.53|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.53|-0.15|0.356
71062134|NCT01217112|141632505|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.188||0.472|TWO_SIDED|90.0|-0.18|0.45|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.45|-0.18|0.472
71062135|NCT01217112|141632506|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.181||0.115|TWO_SIDED|90.0|-0.59|0.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.01|-0.59|0.115
71062136|NCT01217112|141632506|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.177||0.782|TWO_SIDED|90.0|-0.25|0.35|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.35|-0.25|0.782
71062137|NCT01217112|141632506|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.173||0.902|TWO_SIDED|90.0|-0.27|0.31|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.31|-0.27|0.902
71062138|NCT01217112|141632506|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.166||0.993|TWO_SIDED|90.0|-0.28|0.28|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.28|-0.28|0.993
71062139|NCT01217112|141632507|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.143||0.956|TWO_SIDED|90.0|-0.23|0.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.25|-0.23|0.956
71062140|NCT01217112|141632507|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.144||0.705|TWO_SIDED|90.0|-0.19|0.3|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.30|-0.19|0.705
71062141|NCT01217112|141632507|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.148||0.466|TWO_SIDED|90.0|-0.14|0.36|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.36|-0.14|0.466
71110295|NCT01118780|141726243|SUPERIORITY_OR_OTHER||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.26||0.515|TWO_SIDED|95.0|-0.34|0.68||The p-value is for the change from baseline to Week 10 in BPI-SF Relations With Other People Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.68|-0.34|0.515
70936931|NCT01918033|141373669|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.04||||0.557|TWO_SIDED|95.0|-0.1|0.18|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Nasal Congestion Nasal Symptom Sub-Score at Week 2|||0.18|-0.10|0.557
71062142|NCT01217112|141632507|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.136||0.876|TWO_SIDED|90.0|-0.21|0.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.25|-0.21|0.876
71062143|NCT01217112|141632508|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.034||0.408|TWO_SIDED|90.0|-0.03|0.09|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.09|-0.03|0.408
71110296|NCT01118780|141726243|SUPERIORITY_OR_OTHER||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.34||0.141|TWO_SIDED|95.0|-0.17|1.18||The p-value is for the change from baseline to Week 10 in BPI-SF Sleep Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.18|-0.17|0.141
70936932|NCT01918033|141373669|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.11||||0.119|TWO_SIDED|95.0|-0.25|0.03|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Nasal Itching Nasal Symptom Sub-Score at Week 2|||0.03|-0.25|0.119
70936933|NCT01918033|141373669|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.06||||0.403|TWO_SIDED|95.0|-0.2|0.08|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Nasal Itching Nasal Symptom Sub-Score at Week 2|||0.08|-0.20|0.403
70936934|NCT01918033|141373670|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.06||||0.376|TWO_SIDED|95.0|-0.2|0.07|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Swelling of INCM at Week 2|||0.07|-0.20|0.376
71062144|NCT01217112|141632508|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.032||0.714|TWO_SIDED|90.0|-0.04|0.07|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.07|-0.04|0.714
71062145|NCT01217112|141632508|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.032||0.267|TWO_SIDED|90.0|-0.09|0.02|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.02|-0.09|0.267
71062146|NCT01217112|141632508|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.032||0.484|TWO_SIDED|90.0|-0.03|0.08|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.08|-0.03|0.484
71062147|NCT01217112|141632509|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.039||0.56|TWO_SIDED|90.0|-0.09|0.04|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.04|-0.09|0.560
71062148|NCT01217112|141632509|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.037||0.956|TWO_SIDED|90.0|-0.06|0.06|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.06|-0.06|0.956
71062149|NCT01217112|141632509|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.039||0.403|TWO_SIDED|90.0|-0.1|0.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.03|-0.10|0.403
71062150|NCT01217112|141632509|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.037||0.617|TWO_SIDED|90.0|-0.04|0.08|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.08|-0.04|0.617
71062151|NCT01217112|141632510|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.108||0.815|TWO_SIDED|90.0|-0.16|0.21|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.21|-0.16|0.815
71062152|NCT01217112|141632510|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.105||0.418|TWO_SIDED|90.0|-0.09|0.26|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.26|-0.09|0.418
71110297|NCT01118780|141726243|SUPERIORITY_OR_OTHER||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.29||0.088|TWO_SIDED|95.0|-0.07|1.07||The p-value is for the change from baseline to Week 10 in BPI-SF Enjoyment of Life Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.07|-0.07|0.088
71062153|NCT01217112|141632510|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.111||0.236|TWO_SIDED|90.0|-0.05|0.32|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.32|-0.05|0.236
71110298|NCT01118780|141726244|SUPERIORITY_OR_OTHER||LS mean difference|-5.76|STANDARD_ERROR_OF_MEAN|1.87||0.002|TWO_SIDED|95.0|-9.4|-2.1|||ANCOVA||LS mean difference was calculated by placebo minus duloxetine. Negative values indicated improvement over placebo.|||-2.1|-9.4|0.002
71110299|NCT01118780|141726246|SUPERIORITY_OR_OTHER||LS mean difference|1.13|STANDARD_ERROR_OF_MEAN|0.43||0.01|TWO_SIDED|95.0|0.27|1.98||The p-value is for the change from baseline to Week 10 in SDS for Work/School Impairment Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.98|0.27|0.010
71062154|NCT01217112|141632510|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.103||0.556|TWO_SIDED|90.0|-0.11|0.23|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.23|-0.11|0.556
71062155|NCT01217112|141632511|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.241||0.329|TWO_SIDED|90.0|-0.64|0.17|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.17|-0.64|0.329
71062156|NCT01217112|141632511|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.236||0.232|TWO_SIDED|90.0|-0.11|0.68|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.68|-0.11|0.232
71062157|NCT01217112|141632511|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.222||0.164|TWO_SIDED|90.0|-0.06|0.68|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.68|-0.06|0.164
71062158|NCT01217112|141632511|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.232||0.302|TWO_SIDED|90.0|-0.15|0.63|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.63|-0.15|0.302
71062159|NCT01217112|141632512|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.231||0.614|TWO_SIDED|90.0|-0.5|0.27|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.27|-0.50|0.614
71062160|NCT01217112|141632512|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.227||0.669|TWO_SIDED|90.0|-0.28|0.48|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.48|-0.28|0.669
71062161|NCT01217112|141632512|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.24||0.621|TWO_SIDED|90.0|-0.28|0.52|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.52|-0.28|0.621
71062162|NCT01217112|141632512|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.222||0.867|TWO_SIDED|90.0|-0.33|0.41|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.41|-0.33|0.867
71062163|NCT01217112|141632513|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.55|STANDARD_ERROR_OF_MEAN|2.624||0.335|TWO_SIDED|90.0|-1.84|6.95|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||6.95|-1.84|0.335
71062164|NCT01217112|141632513|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.36|STANDARD_ERROR_OF_MEAN|2.545||0.358|TWO_SIDED|90.0|-1.9|6.62|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||6.62|-1.90|0.358
71062165|NCT01217112|141632513|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|2.406||0.9|TWO_SIDED|90.0|-3.72|4.33|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||4.33|-3.72|0.900
71062166|NCT01217112|141632513|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.02|STANDARD_ERROR_OF_MEAN|2.486||0.019|TWO_SIDED|90.0|1.86|10.19|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||10.19|1.86|0.019
71062167|NCT01217112|141632514|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.245||0.325|TWO_SIDED|90.0|-0.65|0.17|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.17|-0.65|0.325
71062168|NCT01217112|141632514|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.238||0.438|TWO_SIDED|90.0|-0.21|0.59|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.59|-0.21|0.438
71062169|NCT01217112|141632514|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.226||0.701|TWO_SIDED|90.0|-0.29|0.47|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.47|-0.29|0.701
71062170|NCT01217112|141632514|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.232||0.624|TWO_SIDED|90.0|-0.5|0.27|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.27|-0.50|0.624
71062171|NCT01217112|141632515|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.058||0.233|TWO_SIDED|90.0|-0.17|0.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.03|-0.17|0.233
71062172|NCT01217112|141632515|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.056||0.727|TWO_SIDED|90.0|-0.07|0.11|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.11|-0.07|0.727
71062173|NCT01217112|141632515|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.053||0.593|TWO_SIDED|90.0|-0.06|0.12|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.12|-0.06|0.593
71062174|NCT01217112|141632515|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.056||0.075|TWO_SIDED|90.0|-0.2|-0.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||-0.01|-0.20|0.075
71062175|NCT01217112|141632516|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.084||0.236|TWO_SIDED|90.0|-0.04|0.24|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.24|-0.04|0.236
71062176|NCT01217112|141632516|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.082||0.579|TWO_SIDED|90.0|-0.09|0.18|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.18|-0.09|0.579
71062177|NCT01217112|141632516|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.077||0.837|TWO_SIDED|90.0|-0.15|0.11|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.11|-0.15|0.837
71062178|NCT01217112|141632516|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.081||0.467|TWO_SIDED|90.0|-0.08|0.19|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.19|-0.08|0.467
71062179|NCT01217112|141632517|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.613||0.533|TWO_SIDED|90.0|-1.41|0.64|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.64|-1.41|0.533
71062180|NCT01217112|141632517|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.585||0.804|TWO_SIDED|90.0|-0.84|1.13|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.13|-0.84|0.804
71062181|NCT01217112|141632517|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.556||0.916|TWO_SIDED|90.0|-0.87|0.99|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.99|-0.87|0.916
71062182|NCT01217112|141632517|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|0.583||0.04|TWO_SIDED|90.0|-2.2|-0.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||-0.25|-2.20|0.040
71062183|NCT01217112|141632518|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.9|STANDARD_ERROR_OF_MEAN|10.838||0.366|TWO_SIDED|90.0|-28.06|8.27|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||8.27|-28.06|0.366
71062184|NCT01217112|141632518|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.11|STANDARD_ERROR_OF_MEAN|10.692||0.844|TWO_SIDED|90.0|-15.81|20.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||20.03|-15.81|0.844
71062185|NCT01217112|141632518|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.96|STANDARD_ERROR_OF_MEAN|10.026||0.118|TWO_SIDED|90.0|-32.76|0.84|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.84|-32.76|0.118
71062186|NCT01217112|141632518|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.67|STANDARD_ERROR_OF_MEAN|10.256||0.518|TWO_SIDED|90.0|-23.86|10.51|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||10.51|-23.86|0.518
71062187|NCT01217112|141632519|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.294||0.576|TWO_SIDED|90.0|-0.66|0.33|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.33|-0.66|0.576
71062188|NCT01217112|141632519|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.283||0.648|TWO_SIDED|90.0|-0.6|0.34|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.34|-0.60|0.648
71062189|NCT01217112|141632519|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.269||0.447|TWO_SIDED|90.0|-0.66|0.24|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.24|-0.66|0.447
70936935|NCT01918033|141373670|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.714|TWO_SIDED|95.0|-0.16|0.11|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Swelling of INCM at Week 2|||0.11|-0.16|0.714
70936936|NCT01918033|141373670|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.725|TWO_SIDED|95.0|-0.19|0.13|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Coloring of INCM at Week 2|||0.13|-0.19|0.725
70936937|NCT01918033|141373670|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.708|TWO_SIDED|95.0|-0.19|0.13|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Coloring of INCM at Week 2|||0.13|-0.19|0.708
70936938|NCT01918033|141373670|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.03||||0.68|TWO_SIDED|95.0|-0.1|0.16|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in NDP at Week 2|||0.16|-0.10|0.680
71062190|NCT01217112|141632519|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.283||0.273|TWO_SIDED|90.0|-0.79|0.16|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.16|-0.79|0.273
71062191|NCT01217112|141632520|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|1.097||0.615|TWO_SIDED|90.0|-2.4|1.29|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.29|-2.40|0.615
71062192|NCT01217112|141632520|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.973||0.342|TWO_SIDED|90.0|-0.7|2.57|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.57|-0.70|0.342
71062193|NCT01217112|141632520|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.934||0.314|TWO_SIDED|90.0|-2.52|0.62|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.62|-2.52|0.314
71062194|NCT01217112|141632520|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.964||0.889|TWO_SIDED|90.0|-1.48|1.75|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.75|-1.48|0.889
71062195|NCT01217112|141632521|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|50.89|STANDARD_ERROR_OF_MEAN|168.459||0.764|TWO_SIDED|90.0|-232.02|333.8|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||333.80|-232.02|0.764
71062196|NCT01217112|141632521|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-70.76|STANDARD_ERROR_OF_MEAN|156.72||0.654|TWO_SIDED|90.0|-333.96|192.44|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||192.44|-333.96|0.654
71062197|NCT01217112|141632521|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-111.5|STANDARD_ERROR_OF_MEAN|146.276||0.45|TWO_SIDED|90.0|-357.17|134.16|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||134.16|-357.17|0.450
71062198|NCT01217112|141632521|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|97.42|STANDARD_ERROR_OF_MEAN|149.124||0.517|TWO_SIDED|90.0|-153.02|347.86|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||347.86|-153.02|0.517
71062199|NCT01217112|141632522|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.33|STANDARD_ERROR_OF_MEAN|40.94||0.84|TWO_SIDED|90.0|-60.28|76.94|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||76.94|-60.28|0.840
70941739|NCT04748445|141383935|OTHER||Slope|0.0008249|STANDARD_ERROR_OF_MEAN|1.815||0.6503|TWO_SIDED|90.0|-0.002183|0.003833|||Mixed Models Analysis|||MM\_MFCC 1st order delta 02 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.003833|-0.002183|0.6503
71062200|NCT01217112|141632522|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.31|STANDARD_ERROR_OF_MEAN|39.521||0.834|TWO_SIDED|90.0|-57.92|74.55|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||74.55|-57.92|0.834
71062201|NCT01217112|141632522|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.62|STANDARD_ERROR_OF_MEAN|39.044||0.767|TWO_SIDED|90.0|-77.06|53.81|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||53.81|-77.06|0.767
71062202|NCT01217112|141632522|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|42.51|STANDARD_ERROR_OF_MEAN|39.68||0.289|TWO_SIDED|90.0|-23.99|109.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||109.01|-23.99|0.289
71110300|NCT01118780|141726246|SUPERIORITY_OR_OTHER||LS mean difference|0.9|STANDARD_ERROR_OF_MEAN|0.29||0.002|TWO_SIDED|95.0|0.32|1.48||The p-value is for the change from baseline to Week 10 in SDS for Social Life/Leisure Activities Impairment Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.48|0.32|0.002
71110301|NCT01118780|141726246|SUPERIORITY_OR_OTHER||LS mean difference|1.21|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|0.61|1.81||The p-value is for the change from baseline to Week 10 in SDS for Family/Home Management Impairment Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.81|0.61|<0.001
71110302|NCT01118780|141726247|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for percentage of participants having HAMA response at Week 10 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||<0.001
71110303|NCT01118780|141726247|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for percentage of participants having remission (HAMA Total Score ≤7) at Week 10 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||<0.001
71110304|NCT01118780|141726247|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for percentage of participants having remission (HAMA Total Score ≤10) at Week 10 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||<0.001
71110305|NCT01118780|141726248|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for the percentage of participants having functional remission (SDS Global Score ≤5) at Week 10 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||<0.001
71110306|NCT01118780|141726248|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for the percentage of participants having functional remission (SDS Global Score ≤6) at Week 10 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||<0.001
71110307|NCT01118780|141726249|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||The p-value is for the percentage of participants having HAMA sustained improvement overall and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||0.001
71110308|NCT01118780|141726249|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||The p-value is for the percentage of participants having HAMA sustained improvement from Week 2 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||0.038
70936939|NCT01918033|141373670|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.06||||0.373|TWO_SIDED|95.0|-0.07|0.19|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in NDP at Week 2|||0.19|-0.07|0.373
71110309|NCT01118780|141726253|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||The p-value was adjusted for pooled investigator.|Log Rank|||||||0.005
71110310|NCT01118780|141726254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for the time to first remission (HAMA Total Score ≤10) and was adjusted for pooled investigator.|Log Rank|||||||<0.001
71110311|NCT01118780|141726255|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||The p-value was adjusted for pooled investigator.|Log Rank|||||||0.001
71110312|NCT01118780|141726256|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||The p-value is for the time to first functional remission (SDS Global Functional Impairment Score ≤5) and was adjusted for pooled investigator.|Log Rank|||||||0.006
71110313|NCT01118780|141726256|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||The p-value is for time to first functional remission (SDS Global Functional Impairment Score ≤6) and was adjusted for pooled investigator.|Log Rank|||||||0.003
71110314|NCT01118780|141726257|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value was adjusted for pooled investigator.|Log Rank|||||||<0.001
71110315|NCT05018689|141726270|SUPERIORITY||Mean Difference (Net)|0.04||||0.642|TWO_SIDED|95.0|-0.13|0.22|||Regression, Linear|||How confident to identify someone showing depression?||0.22|-0.13|0.642
71110316|NCT05018689|141726270|SUPERIORITY||Mean Difference (Net)|0.02||||0.864|TWO_SIDED|95.0|-0.21|0.25|||Regression, Linear|||How confident to help a friend?||0.25|-0.21|0.864
71110317|NCT05018689|141726271|SUPERIORITY||comparison of odds ratios|0.78||||0.336|TWO_SIDED|95.0|0.47|1.3|||Regression, Logistic|||||1.30|0.47|0.336
71110318|NCT05018689|141726272|SUPERIORITY||comparison of odds ratios|1.05||||0.806|TWO_SIDED|95.0|0.7|1.59|||Regression, Logistic|||Depression runs in families. Answer: true||1.59|0.70|0.806
71110319|NCT05018689|141726272|SUPERIORITY||comparison of odds ratios|0.96||||0.781|TWO_SIDED|95.0|0.71|1.3|||Regression, Logistic|||Depression can be controlled through willpower. Answer: false||1.30|0.71|0.781
71110320|NCT05018689|141726272|SUPERIORITY||comparison of odds ratios|0.93||||0.72|TWO_SIDED|95.0|0.62|1.39|||Regression, Logistic|||Depression is treatable. Answer: true||1.39|0.62|0.720
71110321|NCT05018689|141726272|SUPERIORITY||comparison of odds ratios|1.11||||0.784|TWO_SIDED|95.0|0.52|2.38|||Regression, Logistic|||Abuse of alcohol and drugs can be a sign of depression. Answer: true||2.38|0.52|0.784
71110322|NCT05018689|141726272|SUPERIORITY||comparison of odds ratios|1.08||||0.662|TWO_SIDED|95.0|0.76|1.55|||Regression, Logistic|||Depression is a sign of personal weakness. Answer: false||1.55|0.76|0.662
70941740|NCT04748445|141383935|OTHER||Slope|-1.188|STANDARD_ERROR_OF_MEAN|1.322||0.3705|TWO_SIDED|90.0|-3.379|1.003|||Mixed Models Analysis|||MM\_MFCC 1st order delta 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-3).||1.003|-3.379|0.3705
71110323|NCT05018689|141726273|SUPERIORITY||comparison of odds ratios|0.8||||0.34|TWO_SIDED|95.0|0.51|1.26|||Regression, Logistic|||Difficulty concentrating or making decisions||1.26|0.51|0.340
71110324|NCT05018689|141726273|SUPERIORITY||comparison of odds ratios|0.81||||0.265|TWO_SIDED|95.0|0.56|1.17|||Regression, Logistic|||Feeling angry||1.17|0.56|0.265
71110325|NCT05018689|141726273|SUPERIORITY||comparison of odds ratios|0.7||||0.259|TWO_SIDED|95.0|0.38|1.3|||Regression, Logistic|||Changes in sleep patterns||1.30|0.38|0.259
71110326|NCT05018689|141726273|SUPERIORITY||comparison of odds ratios|1.12||||0.45|TWO_SIDED|95.0|0.84|1.49|||Regression, Logistic|||Frequent unexplained aches and pains||1.49|0.84|0.450
71110327|NCT05018689|141726273|SUPERIORITY||comparison of odds ratios|2.28||||0.025|TWO_SIDED|95.0|1.11|4.69|||Regression, Logistic|||Feeling tired or less energetic||4.69|1.11|0.025
71110328|NCT05018689|141726273|SUPERIORITY||comparison of odds ratios|1.01||||0.937|TWO_SIDED|95.0|0.71|1.44|||Regression, Logistic|||Eating more than usual||1.44|0.71|0.937
71110329|NCT05018689|141726273|SUPERIORITY||comparison of odds ratios|0.83||||0.447|TWO_SIDED|95.0|0.52|1.34|||Regression, Logistic|||Feeling irritable or restless||1.34|0.52|0.447
71110330|NCT05018689|141726274|SUPERIORITY||Mean Difference (Net)|0.02||||0.8|TWO_SIDED|95.0|-0.11|0.14|||Regression, Linear|||Friend||0.14|-0.11|0.800
71110331|NCT05018689|141726274|SUPERIORITY||Mean Difference (Net)|-0.05||||0.451|TWO_SIDED|95.0|-0.18|0.08|||Regression, Linear|||Parent/guardian||0.08|-0.18|0.451
71110332|NCT05018689|141726274|SUPERIORITY||Mean Difference (Net)|0.07||||0.335|TWO_SIDED|95.0|-0.07|0.2|||Regression, Linear|||School counselor||0.2|-0.07|0.335
71110333|NCT05018689|141726274|SUPERIORITY||Mean Difference (Net)|-0.04||||0.554|TWO_SIDED|95.0|-0.17|0.09|||Regression, Linear|||Teacher||0.09|-0.17|0.554
70852429|NCT04657666|141193468|SUPERIORITY||Combined least mean square difference|0.04|STANDARD_ERROR_OF_MEAN|0.1||0.7152|TWO_SIDED|95.0|-0.16|0.23||Based on a combination of 300 linear mixed models for crossover data on the response variable change from baseline in LLMT-6 with period level LLMT-6 baseline covariate, treatment group, period, and sequence as fixed effects.|Mixed Models Analysis|Pattern mixture model (PMM) control-based imputation, mixed model repeated measures (MMRM)||||0.23|-0.16|0.7152
71062203|NCT01217112|141632523|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.106||0.569|TWO_SIDED|90.0|-0.24|0.12|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.12|-0.24|0.569
71062204|NCT01217112|141632523|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.101||0.984|TWO_SIDED|90.0|-0.17|0.17|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.17|-0.17|0.984
71062205|NCT01217112|141632523|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.098||0.176|TWO_SIDED|90.0|-0.3|0.03|||ANCOVA|||v Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.03|-0.30|0.176
71062206|NCT01217112|141632523|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.099||0.895|TWO_SIDED|90.0|-0.15|0.18|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.18|-0.15|0.895
71062207|NCT01217112|141632524|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.745||0.871|TWO_SIDED|90.0|-1.13|1.37|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.37|-1.13|0.871
71062208|NCT01217112|141632524|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.721||0.826|TWO_SIDED|90.0|-1.05|1.37|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.37|-1.05|0.826
71062209|NCT01217112|141632524|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.703||0.693|TWO_SIDED|90.0|-1.46|0.9|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.90|-1.46|0.693
71110334|NCT05018689|141726274|SUPERIORITY||Mean Difference (Net)|-0.04||||0.541|TWO_SIDED|95.0|-0.19|0.1|||Regression, Linear|||Mental health professional||0.10|-0.19|0.541
70936940|NCT01918033|141373671|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.01||||0.849|TWO_SIDED|95.0|-0.14|0.12|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Eye Symptom Score at Week 2|||0.12|-0.14|0.849
71062210|NCT01217112|141632524|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.722||0.536|TWO_SIDED|90.0|-0.76|1.66|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.66|-0.76|0.536
71062211|NCT01217112|141632525|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|8.633||0.878|TWO_SIDED|90.0|-15.8|13.13|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||13.13|-15.80|0.878
71110335|NCT05018689|141726274|SUPERIORITY||Mean Difference (Net)|0.05||||0.454|TWO_SIDED|95.0|-0.09|0.19|||Regression, Linear|||Doctor||0.19|-0.09|0.454
71110336|NCT05018689|141726274|SUPERIORITY||Mean Difference (Net)|-0.02||||0.749|TWO_SIDED|95.0|-0.16|0.12|||Regression, Linear|||Internet/website||0.12|-0.16|0.749
71110337|NCT05018689|141726274|SUPERIORITY||Mean Difference (Net)|-0.13||||0.03|TWO_SIDED|95.0|-0.24|-0.01|||Regression, Linear|||Clergy, priest, rabbi, or other religious person||-0.01|-0.24|0.030
71110338|NCT05018689|141726274|SUPERIORITY||Mean Difference (Net)|0.06||||0.334|TWO_SIDED|95.0|-0.06|0.18|||Regression, Linear|||Phone helpline||0.18|-0.06|0.334
71110339|NCT05018689|141726274|SUPERIORITY||Mean Difference (Net)|0.07||||0.243|TWO_SIDED|95.0|-0.05|0.2|||Regression, Linear|||Crisis textline||0.20|-0.05|0.243
71110340|NCT05018689|141726274|SUPERIORITY||Mean Difference (Net)|-0.05||||0.492|TWO_SIDED|95.0|-0.19|0.09|||Regression, Linear|||Other relative (i.e., sister, brother, aunt, uncle)||0.09|-0.19|0.492
71110341|NCT05018689|141726274|SUPERIORITY||Mean Difference (Net)|-0.04||||0.61|TWO_SIDED|95.0|-0.17|0.1|||Regression, Linear|||Boyfriend or girlfriend||0.10|-0.17|0.610
71110342|NCT05018689|141726274|SUPERIORITY||Mean Difference (Net)|-0.12||||0.061|TWO_SIDED|95.0|-0.25|0.01|||Regression, Linear|||Coach||0.01|-0.25|0.061
71110343|NCT05018689|141726275|SUPERIORITY||comparison of odds ratios|1.27||||0.086|TWO_SIDED|95.0|0.97|1.66|||Regression, Logistic|||If you had depression symptoms for more than 2 weeks, would you ask for help?||1.66|0.97|0.086
71110344|NCT05018689|141726275|SUPERIORITY||comparison of odds ratios|1.13||||0.526|TWO_SIDED|95.0|0.77|1.66|||Regression, Logistic|||If you thought you had mental health issues, is there a trusted adult you would go to?||1.66|0.77|0.526
71110345|NCT05018689|141726276|SUPERIORITY||Mean Difference (Net)|0.06||||0.199|TWO_SIDED|95.0|-0.03|0.16|||Regression, Linear|||Do you know how to get help in your school?||0.16|-0.03|0.199
71110346|NCT05018689|141726277|SUPERIORITY||Mean Difference (Net)|-0.25|||<|0.001|TWO_SIDED|95.0|-0.38|-0.12|||Regression, Linear|||The new student is more dangerous than other students||-0.12|-0.38|<0.001
71110347|NCT05018689|141726277|SUPERIORITY||Mean Difference (Net)|-0.18||||0.003|TWO_SIDED|95.0|-0.29|-0.06|||Regression, Linear|||The student is to blame for his or her condition||-0.06|-0.29|0.003
71110348|NCT05018689|141726277|SUPERIORITY||Mean Difference (Net)|0.06||||0.31|TWO_SIDED|95.0|-0.06|0.18|||Regression, Linear|||I would have sympathy for the new student||0.18|-0.06|0.310
71110349|NCT05018689|141726277|SUPERIORITY||Mean Difference (Net)|-0.1||||0.114|TWO_SIDED|95.0|-0.21|0.02|||Regression, Linear|||The new student makes me feel scared||0.02|-0.21|0.114
71062212|NCT01217112|141632525|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.85|STANDARD_ERROR_OF_MEAN|8.377||0.919|TWO_SIDED|90.0|-13.18|14.89|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||14.89|-13.18|0.919
71062213|NCT01217112|141632525|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.72|STANDARD_ERROR_OF_MEAN|7.989||0.557|TWO_SIDED|90.0|-8.67|18.11|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||18.11|-8.67|0.557
71110350|NCT05018689|141726277|SUPERIORITY||Mean Difference (Net)|0.02||||0.738|TWO_SIDED|95.0|-0.1|0.15|||Regression, Linear|||The new student makes me feel uncomfortable||0.15|-0.10|0.738
71110351|NCT05018689|141726277|SUPERIORITY||Mean Difference (Net)|0.12||||0.04|TWO_SIDED|95.0|0.01|0.24|||Regression, Linear|||I would help the new student even if I did not know him or her well||0.24|0.01|0.040
71110352|NCT05018689|141726277|SUPERIORITY||Mean Difference (Net)|-0.17||||0.006|TWO_SIDED|95.0|-0.29|-0.05|||Regression, Linear|||I would try to stay away from the new student||-0.05|-0.29|0.006
71110353|NCT05018689|141726277|SUPERIORITY||Mean Difference (Net)|-0.02||||0.798|TWO_SIDED|95.0|-0.15|0.11|||Regression, Linear|||The new student would be made fun of at my school||0.11|-0.15|0.798
71110354|NCT05018689|141726277|SUPERIORITY||Mean Difference (Net)|-0.09||||0.197|TWO_SIDED|95.0|-0.22|0.05|||Regression, Linear|||The new student would be ignored at my school||0.05|-0.22|0.197
71110355|NCT05018689|141726277|SUPERIORITY||Mean Difference (Net)|0.03||||0.623|TWO_SIDED|95.0|-0.1|0.16|||Regression, Linear|||I think other students in my school would try to help the new student||0.16|-0.10|0.623
71110356|NCT05018689|141726278|SUPERIORITY||Mean Difference (Net)|0.05||||0.718|TWO_SIDED|95.0|-0.21|0.3|||Regression, Linear|||On a scale from 1 to 7, if you were seen going into the office of your school social worker or school psychologist, how would you feel?||0.30|-0.21|0.718
71110357|NCT05018689|141726279|SUPERIORITY||Mean Difference (Net)|0.21||||0.09|TWO_SIDED|95.0|-0.03|0.46|||Regression, Linear|||How comfortable are you talking about mental health issues with other students at your school?||0.46|-0.03|0.090
71110358|NCT05018689|141726280|SUPERIORITY||comparison of odds ratios|0.99||||0.944|TWO_SIDED|95.0|0.67|1.44|||Regression, Logistic|||Depression||1.44|0.67|0.944
71110359|NCT05018689|141726280|SUPERIORITY||comparison of odds ratios|1.18||||0.369|TWO_SIDED|95.0|0.82|1.68|||Regression, Logistic|||Anxiety||1.68|0.82|0.369
71110360|NCT05018689|141726280|SUPERIORITY||comparison of odds ratios|1.07||||0.676|TWO_SIDED|95.0|0.77|1.5|||Regression, Logistic|||Thoughts of suicide||1.50|0.77|0.676
71110361|NCT05018689|141726280|SUPERIORITY||comparison of odds ratios|0.79||||0.432|TWO_SIDED|95.0|0.44|1.42|||Regression, Logistic|||I do not think there are any mental health issues that are concerning for students||1.42|0.44|0.432
71110362|NCT05018689|141726280|SUPERIORITY||comparison of odds ratios|0.87||||0.533|TWO_SIDED|95.0|0.56|1.35|||Regression, Logistic|||Other||1.35|0.56|0.533
71110363|NCT05018689|141726281|SUPERIORITY||Mean Difference (Net)|-0.01||||0.769|TWO_SIDED|95.0|-0.11|0.08|||Regression, Linear|||How much do your teachers know about addressing student mental health needs?||0.08|-0.11|0.769
71110364|NCT05018689|141726281|SUPERIORITY||Mean Difference (Net)|0.05||||0.315|TWO_SIDED|95.0|-0.05|0.16|||Regression, Linear|||How much do your school counselors know about addressing student mental health needs?||0.16|-0.05|0.315
71110365|NCT05018689|141726282|SUPERIORITY||comparison of odds ratios|0.86||||0.345|TWO_SIDED|95.0|0.63|1.18|||Regression, Logistic|||Mental health information sheets at school||1.18|0.63|0.345
71110366|NCT05018689|141726282|SUPERIORITY||comparison of odds ratios|0.98||||0.899|TWO_SIDED|95.0|0.73|1.33|||Regression, Logistic|||Class activities about mental health||1.33|0.73|0.899
71110367|NCT05018689|141726282|SUPERIORITY||comparison of odds ratios|1.08||||0.612|TWO_SIDED|95.0|0.8|1.48|||Regression, Logistic|||Mental health information on school website||1.48|0.80|0.612
71110368|NCT05018689|141726282|SUPERIORITY||comparison of odds ratios|1.14||||0.476|TWO_SIDED|95.0|0.79|1.65|||Regression, Logistic|||Other||1.65|0.79|0.476
71110369|NCT05018689|141726283|SUPERIORITY||Mean Difference (Net)|-0.09||||0.141|TWO_SIDED|95.0|-0.22|0.03|||Regression, Linear|||On average, how often do your teachers speak to you about your emotions and feelings?||0.03|-0.22|0.141
71110370|NCT05018689|141726284|SUPERIORITY||Mean Difference (Net)|0.04||||0.392|TWO_SIDED|95.0|-0.05|0.13|||Regression, Linear|||Would you like your teachers to speak to you about your emotions and feelings?||0.13|-0.05|0.392
71110371|NCT02379052|141726288|SUPERIORITY||Least Squares (LS) Mean Difference|-1.7||||0.0304|TWO_SIDED|95.0|-3.22|-0.16|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||-0.16|-3.22|0.0304
71110372|NCT02379052|141726289|SUPERIORITY||Least Squares Mean Difference|-26.45||||0.0312|TWO_SIDED|95.0|-50.523|-2.387|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||-2.387|-50.523|0.0312
70936941|NCT01918033|141373671|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.07||||0.26|TWO_SIDED|95.0|-0.2|0.06|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Eye Symptom Score at Week 2|||0.06|-0.20|0.260
70936942|NCT01918033|141373672|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.826||||0.34|TWO_SIDED|95.0|0.558|1.223|||Regression, Logistic|Logistic model with global improvement rate as response variable and treatment, age strata, and severity as factors|Difference in the number of participants with moderate or remarkable improvement at Week 2. An odds ratio \>1 is in favor of the first group of the pairwise comparison.|||1.223|0.558|0.340
70936943|NCT01918033|141373672|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.755||||0.159|TWO_SIDED|95.0|0.51|1.116|||Regression, Logistic|Logistic model with global improvement rate as response variable and treatment, age strata, and severity as factors|Difference in the number of participants with moderate or remarkable improvement at Week 2. An odds ratio \>1 is in favor of the first group of the pairwise comparison.|||1.116|0.510|0.159
70936944|NCT01918033|141373673|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.02||||0.705|TWO_SIDED|95.0|-0.09|0.14|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Interference with Daily Activities at Week 2|||0.14|-0.09|0.705
70936945|NCT01918033|141373673|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.02||||0.782|TWO_SIDED|95.0|-0.13|0.1|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Interference with Daily Activities at Week 2|||0.10|-0.13|0.782
70936946|NCT01918033|141373674|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.1||||0.175|TWO_SIDED|95.0|-0.24|0.04|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Sneezing at Week 2|||0.04|-0.24|0.175
70936947|NCT01918033|141373674|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.12||||0.098|TWO_SIDED|95.0|-0.26|0.02|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Sneezing at Week 2|||0.02|-0.26|0.098
70936948|NCT01918033|141373674|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.12||||0.13|TWO_SIDED|95.0|-0.04|0.27|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Rhinorrhea at Week 2|||0.27|-0.04|0.130
70936949|NCT01918033|141373674|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.07||||0.375|TWO_SIDED|95.0|-0.08|0.22|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Rhinorrhea at Week 2|||0.22|-0.08|0.375
70936950|NCT01918033|141373674|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.08||||0.285|TWO_SIDED|95.0|-0.07|0.24|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Nasal Congestion at Week 2|||0.24|-0.07|0.285
70936951|NCT01918033|141373674|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.05||||0.49|TWO_SIDED|95.0|-0.1|0.21|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Nasal Congestion at Week 2|||0.21|-0.10|0.490
71062214|NCT01217112|141632525|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.2|STANDARD_ERROR_OF_MEAN|8.328||0.275|TWO_SIDED|90.0|-4.76|23.16|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||23.16|-4.76|0.275
70936952|NCT01918033|141373674|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.08||||0.345|TWO_SIDED|95.0|-0.23|0.08|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Nasal Itching at Week 2|||0.08|-0.23|0.345
70936953|NCT01918033|141373674|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.699|TWO_SIDED|95.0|-0.19|0.13|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Nasal Itching at Week 2|||0.13|-0.19|0.699
71110373|NCT02379052|141726290|SUPERIORITY||Least Squares Mean Difference|-0.8||||0.383|TWO_SIDED|95.0|-2.48|0.96|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||0.96|-2.48|0.3830
70936954|NCT01918033|141373675|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.06||||0.414|TWO_SIDED|95.0|-0.2|0.08|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Eye Symptom Score at Week 2|||0.08|-0.20|0.414
71062215|NCT01217112|141632526|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.45|STANDARD_ERROR_OF_MEAN|16.445||0.528|TWO_SIDED|90.0|-17.12|38.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||38.01|-17.12|0.528
71110374|NCT02379052|141726291|SUPERIORITY||Least Squares Mean Difference|-11.0||||0.4147|TWO_SIDED|95.0|-37.46|15.467|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||15.467|-37.460|0.4147
71110375|NCT02379052|141726292|SUPERIORITY||Percent Difference|26.6||||0.049|TWO_SIDED|95.0|-3.04|51.05|||Clopper-Pearson Exact||Difference is Dupilumab minus Placebo. CI = Confidence interval calculated using Clopper-Pearson Exact method|||51.05|-3.04|0.0490
71110376|NCT02379052|141726293|SUPERIORITY||Percent Difference|26.6||||0.049|TWO_SIDED|95.0|-3.04|51.05|||Clopper-Pearson Exact||Difference is Dupilumab minus Placebo. CI = Confidence interval calculated using Clopper-Pearson Exact method|||51.05|-3.04|0.0490
71110377|NCT02379052|141726294|SUPERIORITY||Least Squares Mean Difference|-23.23||||0.085|TWO_SIDED|95.0|-49.677|3.212|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||3.212|-49.677|0.0850
71110378|NCT02379052|141726295|SUPERIORITY||Least Squares Mean Difference|-13.9||||0.0635|TWO_SIDED|95.0|-28.54|0.78|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.|||0.78|-28.54|0.0635
71062216|NCT01217112|141632526|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|15.825||0.99|TWO_SIDED|90.0|-26.32|26.72|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||26.72|-26.32|0.990
71062217|NCT01217112|141632526|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.39|STANDARD_ERROR_OF_MEAN|15.369||0.776|TWO_SIDED|90.0|-21.37|30.15|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||30.15|-21.37|0.776
71062218|NCT01217112|141632526|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|44.51|STANDARD_ERROR_OF_MEAN|15.834||0.007|TWO_SIDED|90.0|17.98|71.05|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||71.05|17.98|0.007
71062219|NCT01217112|141632527|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.536||0.717|TWO_SIDED|90.0|-0.7|1.09|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.09|-0.70|0.717
71062220|NCT01217112|141632527|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.531||0.218|TWO_SIDED|90.0|-0.23|1.55|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.55|-0.23|0.218
71062221|NCT01217112|141632527|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.514||0.378|TWO_SIDED|90.0|-0.4|1.32|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.32|-0.40|0.378
71062222|NCT01217112|141632527|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.532||0.361|TWO_SIDED|90.0|-0.4|1.38|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.38|-0.40|0.361
71110379|NCT02379052|141726296|SUPERIORITY||Least Squares Mean Difference|-33.65||||0.0608|TWO_SIDED|95.0|-68.828|1.536|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\])|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.|||1.536|-68.828|0.0608
71110380|NCT02379052|141726297|SUPERIORITY||Least Squares Mean Difference|-21.1||||0.0318|TWO_SIDED|95.0|-40.42|-1.86|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.|||-1.86|-40.42|0.0318
71110381|NCT02379052|141726298|SUPERIORITY||Percent Difference|17.8||||0.1365|TWO_SIDED|95.0|-11.54|43.55||P-values were derived by Fisher exact test|Clopper-Pearson Exact|CI = Confidence interval calculated using Exact method|Difference is Dupilumab minus Placebo|||43.55|-11.54|0.1365
71110382|NCT02379052|141726299|SUPERIORITY||Percent Difference|35.0||||0.0044|TWO_SIDED|95.0|5.69|58.34||P-values were derived by Fisher exact test|Clopper-Pearson Exact|CI = Confidence interval calculated using Exact method|Difference is Dupilumab minus Placebo|||58.34|5.69|0.0044
71110383|NCT02379052|141726300|SUPERIORITY||Least Squares Mean Difference|-107.13|||<|0.0001|TWO_SIDED|95.0|-141.215|-73.046|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\])|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.|||-73.046|-141.215|<0.0001
71110384|NCT02379052|141726301|SUPERIORITY||Least Square Mean Difference|-1.6||||0.0006|TWO_SIDED|95.0|-2.5|-0.68|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\])|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.|||-0.68|-2.50|0.0006
70936955|NCT01918033|141373675|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.08||||0.281|TWO_SIDED|95.0|-0.22|0.06|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Eye Symptom Score at Week 2|||0.06|-0.22|0.281
70936956|NCT01702259|141373685|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
70936957|NCT01702259|141373686|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
70936958|NCT01702259|141373687|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
70936959|NCT01702259|141373688|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
71062223|NCT01217112|141632528|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.013||0.417|TWO_SIDED|90.0|-0.01|0.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.03|-0.01|0.417
71062224|NCT01217112|141632528|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.013||0.34|TWO_SIDED|90.0|-0.01|0.04|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.04|-0.01|0.340
71062225|NCT01217112|141632528|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.013||0.915|TWO_SIDED|90.0|-0.02|0.02|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.02|-0.02|0.915
71062226|NCT01217112|141632528|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.013||0.465|TWO_SIDED|90.0|-0.01|0.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.03|-0.01|0.465
71062227|NCT01217112|141632529|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.75|STANDARD_ERROR_OF_MEAN|1.616||0.646|TWO_SIDED|90.0|-1.96|3.45|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.45|-1.96|0.646
71062228|NCT01217112|141632529|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.99|STANDARD_ERROR_OF_MEAN|1.598||0.219|TWO_SIDED|90.0|-0.69|4.66|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||4.66|-0.69|0.219
71062229|NCT01217112|141632529|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.61|STANDARD_ERROR_OF_MEAN|1.563||0.307|TWO_SIDED|90.0|-1.0|4.23|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||4.23|-1.00|0.307
71062230|NCT01217112|141632529|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.52|STANDARD_ERROR_OF_MEAN|1.612||0.348|TWO_SIDED|90.0|-1.17|4.22|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||4.22|-1.17|0.348
71110385|NCT02379052|141726302|SUPERIORITY||Least Squares Mean Difference|0.33||||0.091|TWO_SIDED|95.0|-0.053|0.72|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.|||0.720|-0.053|0.0910
71110386|NCT04419467|141726309|SUPERIORITY||GM % treatment difference (80% CI)|-0.5||||0.485|TWO_SIDED|80.0|-14.8|16.3||One-sided p-value|Mixed Models Repeated Measures Analysis||Data analyzed are log-transformed values of ACR, using MMRM. Comparisons vs. placebo are back-transformed by exponentiation to obtain geometric mean (GM), then expressed as percent treatment difference.|||16.3|-14.8|0.485
70936960|NCT03136861|141373694|SUPERIORITY||Odds Ratio (OR)|1.89||||0.0264|TWO_SIDED|95.0|1.08|3.33|||Regression, Logistic|Logistic regression model: logit (proportion) = treatment + stratification factor of prior exposure to TNF inhibitors (i.e. TNF-naïve or TNFα-IR).||Average Spinal Pain Score \<4 at Week 8||3.33|1.08|0.0264
70936961|NCT03136861|141373694|SUPERIORITY||Odds Ratio (OR)|1.72||||0.072|TWO_SIDED|95.0|0.95|3.1|||Regression, Logistic|Logistic regression model: logit (proportion) = treatment + stratification factor of prior exposure to TNF inhibitors (i.e. TNF-naïve or TNFα-IR)||Total Spinal Pain Score \<4 at Week 8||3.10|0.95|0.0720
70936962|NCT03136861|141373694|SUPERIORITY||Odds Ratio (OR)|2.38||||0.0043|TWO_SIDED|95.0|1.31|4.31|||Regression, Logistic|Logistic regression model: logit (proportion) = treatment + stratification factor of prior exposure to TNF inhibitors (i.e. TNF-naïve or TNFα-IR)||Nocturnal Spinal Pain Score||4.31|1.31|0.0043
70936963|NCT03136861|141373695|SUPERIORITY||Odds Ratio (OR)|1.75||||0.0466|TWO_SIDED|95.0|1.01|3.04|||Regression, Logistic|Logistic regression model: logit (proportion) = treatment + stratification factor of prior exposure to TNF inhibitors (i.e. TNF-naïve or TNFα-IR).||BASDAI Score \<4 at Week 8||3.04|1.01|0.0466
70936964|NCT01235936|141373700|OTHER|The primary endpoint was compared using the Wilcoxon signed-rank test, with an alpha level of 0.05.||||||0.002|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||0.0020
70936965|NCT01235936|141373701|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.0156|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.0156
70936966|NCT01235936|141373702|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.||||||0.0098|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||0.0098
70936967|NCT01235936|141373703|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.0195|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.0195
71062231|NCT01217112|141632530|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.74|STANDARD_ERROR_OF_MEAN|1.299||0.187|TWO_SIDED|90.0|-0.44|3.91|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.91|-0.44|0.187
71110387|NCT04419467|141726309|SUPERIORITY||GM % treatment difference (80% CI)|8.6||||0.75|TWO_SIDED|80.0|-7.2|27.2||One-sided p-value|Mixed Models Repeated Measures Analysis||Data analyzed are log-transformed values of ACR, using MMRM. Comparisons vs. placebo are back-transformed by exponentiation to obtain geometric mean, then expressed as percent treatment difference|||27.2|-7.2|0.750
71110388|NCT05501639|141726326|OTHER|||||||0.758|||||||Log Rank|||||||0.758
71110389|NCT05501639|141726327|OTHER|||||||0.474|||||||Log Rank|||||||0.474
71110390|NCT05501639|141726328|OTHER|||||||0.472|||||||Chi-squared|||||||0.472
71110391|NCT05501639|141726329|OTHER||Incidence rate ratio|0.647|||||TWO_SIDED|95.0|0.261|1.604|||||Incidence rate ratio at 6 months|||1.604|0.261|
71110392|NCT05501639|141726329|OTHER||Incidence rate ratio|1.005|||||TWO_SIDED|95.0|0.513|1.969|||||Incidence rate ratio at 12 months|||1.969|0.513|
71110393|NCT05501639|141726330|OTHER|||||||0.222|||||||Chi-squared|||Hospitalisations||||0.222
71110394|NCT05501639|141726330|OTHER|||||||0.553|||||||Chi-squared|||Asthma-related hospitalisations||||0.553
70852430|NCT02386189|141193488|SUPERIORITY||Mean Difference (Net)|-4.65|STANDARD_DEVIATION|7.3||0.02|TWO_SIDED||||||t-test, 2 sided|||The t-test was conducted on change between baseline and 12-month follow-up.||||0.02
71110395|NCT05501639|141726330|OTHER|||||||0.192|||||||Chi-squared|||ED visits||||0.192
71062232|NCT01217112|141632530|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.72|STANDARD_ERROR_OF_MEAN|1.28||0.578|TWO_SIDED|90.0|-1.43|2.86|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.86|-1.43|0.578
71110396|NCT05501639|141726330|OTHER|||||||0.383|||||||Chi-squared|||Asthma-related ED visits||||0.383
71110397|NCT05501639|141726330|OTHER|||||||0.338|||||||Chi-squared|||OP visits||||0.338
71110398|NCT05501639|141726330|OTHER||||||<|0.0001|||||||Chi-squared|||Asthma-related OP visits||||<0.0001
71110399|NCT05501639|141726331|OTHER|||||||0.538|||||||t-test, 2 sided|||Hospitalisations||||0.538
71110400|NCT05501639|141726331|OTHER|||||||0.913|||||||t-test, 2 sided|||Asthma-related hospitalisations||||0.913
71110401|NCT05501639|141726331|OTHER|||||||0.688|||||||t-test, 2 sided|||ED visits||||0.688
71110402|NCT05501639|141726331|OTHER|||||||0.892|||||||t-test, 2 sided|||Asthma-related ED visits||||0.892
71110403|NCT05501639|141726331|OTHER||||||<|0.0001|||||||t-test, 2 sided|||OP visits||||<0.0001
71110404|NCT05501639|141726331|OTHER|||||||0.002|||||||t-test, 2 sided|||Asthma-related OP visits||||0.002
70852431|NCT02386189|141193489|SUPERIORITY||Mean Difference (Net)|2.91|STANDARD_DEVIATION|5.5||0.06|TWO_SIDED||||||t-test, 2 sided|||||||0.06
70852432|NCT02386189|141193490|SUPERIORITY||Mean Difference (Net)|0.28|STANDARD_DEVIATION|2.7||0.71|TWO_SIDED||||||t-test, 2 sided|||||||0.71
71110405|NCT05501639|141726332|OTHER|||||||0.378|||||||Chi-squared|||||||0.378
71110406|NCT00003869|141726368|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||Log Rank|||||||0.54
71110407|NCT00003869|141726369|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Fisher Exact|||||||0.18
71110408|NCT00003869|141726370|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Log Rank|||||||0.50
71110409|NCT00003869|141726371|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Fisher Exact|||||||0.04
71110410|NCT00003869|141726372|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Fisher Exact|||||||0.18
71110411|NCT01333436|141726412|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.8|STANDARD_DEVIATION|36.8||0.0078||95.0|||||t-test, 2 sided|||||||0.0078
71110412|NCT01333436|141726413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.5|STANDARD_DEVIATION|13.9||0.0675||95.0|||||t-test, 2 sided|||||||0.0675
71110413|NCT01333436|141726414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.4|STANDARD_DEVIATION|4.8||0.1798||95.0|||||t-test, 2 sided|||||||0.1798
71110414|NCT00444106|141726415|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||One-sided exact test for a single propn.|One-sided exact test for a single proportion.||"One-sided null hypothesis that the incidence rate of ABR Wave III latency changes is greater than or equal to 15%.~Increase in ABR Wave III latency between baseline and Day 7 of greater than 0.3 ms."||||<.0001
71110415|NCT00953706|141726443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|1.2||0.1509|TWO_SIDED|95.0|-0.6|4.1|||Mixed Models Analysis|||The primary analysis for the primary efficacy variable was based on a Mixed-Effects Model for Repeated Measures (MMRM). The model included absolute change from baseline in percent predicted forced expiratory volume in 1 second (FEV1) as the dependent variable, treatment (ivacaftor versus placebo) and visit as fixed effects, and participant as a random effect, with adjustment for age and continuous baseline value of percent predicted FEV1.||4.1|-0.6|0.1509
71110416|NCT00953706|141726444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|2.1||0.5408|TWO_SIDED|95.0|-2.9|5.6|||Mixed Models Analysis|||Analysis for the respiratory domain score endpoint was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with the dependent variable being absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for for age and baseline value for CFQ-R score, using unstructured covariance matrix||5.6|-2.9|0.5408
71110417|NCT00953706|141726445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|1.4||0.0384|TWO_SIDED|95.0|-5.6|-0.2|||Mixed Models Analysis|||Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable being absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous age and baseline value for age, sweat chloride, using unstructured covariance matrix.||-0.2|-5.6|0.0384
71117645|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
71062233|NCT01217112|141632530|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.13|STANDARD_ERROR_OF_MEAN|1.249||0.368|TWO_SIDED|90.0|-0.96|3.22|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.22|-0.96|0.368
71062234|NCT01217112|141632530|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|1.304||0.696|TWO_SIDED|90.0|-1.67|2.69|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.69|-1.67|0.696
71062235|NCT01217112|141632531|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|1.32||0.327|TWO_SIDED|90.0|-0.9|3.51|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.51|-0.90|0.327
71062236|NCT01217112|141632531|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|1.303||0.851|TWO_SIDED|90.0|-1.93|2.43|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.43|-1.93|0.851
71062237|NCT01217112|141632531|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|1.281||0.672|TWO_SIDED|90.0|-1.6|2.69|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.69|-1.60|0.672
71062238|NCT01217112|141632531|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|1.327||0.978|TWO_SIDED|90.0|-2.26|2.18|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.18|-2.26|0.978
71062239|NCT01217112|141632532|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.512||0.857|TWO_SIDED|90.0|-0.95|0.76|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.76|-0.95|0.857
70936968|NCT01235936|141373704|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.8262|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.8262
70936969|NCT01235936|141373710|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.002|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.0020
71062240|NCT01217112|141632532|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.549||0.543|TWO_SIDED|90.0|-0.58|1.26|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.26|-0.58|0.543
71062241|NCT01217112|141632532|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.495||0.859|TWO_SIDED|90.0|-0.74|0.92|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.92|-0.74|0.859
71062242|NCT01217112|141632532|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.526||0.467|TWO_SIDED|90.0|-1.27|0.5|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.50|-1.27|0.467
71062243|NCT01217112|141632533|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.406||0.124|TWO_SIDED|90.0|-1.32|0.05|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.05|-1.32|0.124
71110418|NCT00953706|141726446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.5||0.7265|TWO_SIDED|95.0|-1.1|0.7|||Mixed Models Analysis|||The analysis used the linear mixed model with treatment as fixed effects, visit (days on study) and treatment by visit interaction as random effects, with adjustment for age group (\< 18 years and ≥ 18 years) and percent predicted forced expiratory volume (FEV1) severity (\< 70%, ≥ 70% to ≤ 90%, \> 90%) at screening, with random intercept and random slope. Rate of change in the study period is the slope of weight versus time (days) multiplied by the number of days in the study period (112 days).||0.7|-1.1|0.7265
71062244|NCT01217112|141632533|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.439||0.909|TWO_SIDED|90.0|-0.68|0.79|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.79|-0.68|0.909
71062245|NCT01217112|141632533|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.392||0.245|TWO_SIDED|90.0|-1.12|0.2|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.20|-1.12|0.245
70936970|NCT01235936|141373711|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.2383|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.2383
70936971|NCT01235936|141373712|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.0039|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.0039
70936972|NCT01235936|141373713|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.0039|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.0039
70852433|NCT02386189|141193491|SUPERIORITY|||||||0.17|||||||Fisher Exact|||||||0.17
70936973|NCT01262456|141373760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|||<|0.0001|TWO_SIDED|95.0|-0.61|-0.22||A priori threshold for significance was p\<=0.05.|ANCOVA|Repeated measures ANCOVA of change from baseline at Week 1, Months 1, 2, 3, adjusted for age (\<65, ≥65 years), visit, and baseline nocturnal voids.||"Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary outcomes in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.~A summary of mean change in nocturnal voids, assessed longitudinally during 3 months of treatment, is presented below for the FAS using LOCF."||-0.22|-0.61|<0.0001
70936974|NCT01262456|141373760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.0003|TWO_SIDED|95.0|-0.57|-0.17||A priori threshold for significance was p\<=0.05|ANCOVA|Repeated measures ANCOVA of change from baseline at Week 1, Months 1, 2, 3, adjusted for age (\<65, ≥65 years), visit, and baseline nocturnal voids.||"Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary outcomes in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.~A summary of mean change in nocturnal voids, assessed longitudinally during 3 months of treatment, is presented below for the FAS using LOCF."||-0.17|-0.57|0.0003
71062246|NCT01217112|141632533|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.412||0.382|TWO_SIDED|90.0|-1.05|0.33|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.33|-1.05|0.382
71062247|NCT01217112|141632534|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.837||0.376|TWO_SIDED|90.0|-2.15|0.66|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.66|-2.15|0.376
71062248|NCT01217112|141632534|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.908||0.688|TWO_SIDED|90.0|-1.15|1.89|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.89|-1.15|0.688
71062249|NCT01217112|141632534|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.803||0.637|TWO_SIDED|90.0|-1.73|0.96|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.96|-1.73|0.637
71062250|NCT01217112|141632534|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.849||0.355|TWO_SIDED|90.0|-2.22|0.63|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.63|-2.22|0.355
71062251|NCT01217112|141632535|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.391||0.482|TWO_SIDED|90.0|-0.39|0.95|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.95|-0.39|0.482
71062252|NCT01217112|141632535|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.489||0.708|TWO_SIDED|90.0|-0.65|1.02|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.02|-0.65|0.708
71062253|NCT01217112|141632535|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|0.434||0.166|TWO_SIDED|90.0|-0.12|1.37|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.37|-0.12|0.166
71062254|NCT01217112|141632535|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.408||0.424|TWO_SIDED|90.0|-0.37|1.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.03|-0.37|0.424
71062255|NCT01217112|141632536|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|1.26||0.022|TWO_SIDED|90.0|0.94|5.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||5.25|0.94|0.022
71078035|NCT01026818|141664568|SUPERIORITY_OR_OTHER||LS Mean Differences|0.81|STANDARD_ERROR_OF_MEAN|1.2||0.5|TWO_SIDED|95.0|-1.54|3.16||P-value is for Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||3.16|-1.54|0.500
71078036|NCT01026818|141664569|SUPERIORITY_OR_OTHER||LS Mean Differences|0.37|STANDARD_ERROR_OF_MEAN|0.39||0.34||95.0|-0.39|1.14||P-value is for orgasmic function - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.14|-0.39|0.340
71110419|NCT02137070|141726458|SUPERIORITY||||||<|0.01||||||Voxel-size (p-FWE \< 0.01) and voxel-peak (p-unc \< 0.001) were corrected for multiple comparisons.|2x2 Factorial ANOVA in CONN|2x2 Factorial ANOVA in CONN - Group (Bariatric surgery vs. control) \& time (pre-surgery baseline vs. 18-month follow-up)||Analysis of variance comparing change scores from 18 months post-surgery relative to pre-surgical baseline were performed. Change in the surgical group was compared to change for the non-surgical controls. The dependent measures were connectivity strengths seeding from the hippocampus and left dorsal lateral pre-frontal cortex to other cortical areas.||||<0.01
70936975|NCT01262456|141373761|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04||||0.0004|TWO_SIDED|95.0|1.38|3.03||A priori threshold for significance was p\<=0.05.|Generalized Estimating Equation (GEE)|GEE Method for 33% responder status at Week 1, Month 1, Month 2, and Month 3, adjusted for age (\<65, ≥65 years), visit, and baseline nocturnal voids.||Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary endpoints in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.||3.03|1.38|0.0004
70941741|NCT04748445|141383935|OTHER||Slope|-0.0007258|STANDARD_ERROR_OF_MEAN|1.101||0.5111|TWO_SIDED|90.0|-0.002551|0.001099|||Mixed Models Analysis|||MM\_MFCC 1st order delta 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.001099|-0.002551|0.5111
71110420|NCT02292537|141726497|SUPERIORITY||LS Mean Difference|4.9|STANDARD_ERROR_OF_MEAN|0.91||1e-07|TWO_SIDED|95.0|3.1|6.7|||ANCOVA|ANCOVA model with treatment group as a factor and age at Screening and baseline HFMSE score as covariates.||||6.7|3.1|0.0000001
71110421|NCT02292537|141726498|SUPERIORITY||Odds Ratio (OR)|5.59||||0.0006|TWO_SIDED|95.0|2.09|14.91||Based on multiple imputation and logistic regression with treatment effect and adjustment for each participant's age at screening and HFMSE score at baseline.|Regression, Logistic|||||14.91|2.09|0.0006
71110422|NCT02292537|141726498|SUPERIORITY||Difference in Proportions|30.5|||||TWO_SIDED|95.0|12.74|48.31|||||Difference in proportions of Nusinersen minus Sham Procedure are from multiple imputation procedure and are based on binomial proportions.|||48.31|12.74|
71110423|NCT02292537|141726499|SUPERIORITY||Difference in Proportions|13.8||||0.0811|TWO_SIDED|95.0|-6.64|34.17|||Fisher Exact||Difference in proportions of Nusinersen minus Sham Procedure is based on exact unconditional confidence interval.|||34.17|-6.64|0.0811
71110424|NCT02292537|141726500|SUPERIORITY||LS Mean Difference|0.4|||||TWO_SIDED|95.0|0.2|0.7|||||Based on ANCOVA with treatment as a fixed effect and adjustment for each participant's age at screening and number of milestones at baseline.|||0.7|0.2|
71110425|NCT02292537|141726501|SUPERIORITY||LS Mean Differenec|3.7|||||TWO_SIDED|95.0|2.3|5.0|||||From multiple imputation procedure, based on ANCOVA with treatment as a fixed effect and adjustment for each participant's age at screening and derived total score at baseline.|||5.0|2.3|
71110426|NCT02292537|141726502|SUPERIORITY||Difference in Proportions|-1.4|||||TWO_SIDED|95.0|-21.84|19.34|||||Difference in proportions of Nusinersen minus Sham Procedure is based on exact unconditional confidence interval.|||19.34|-21.84|
71110427|NCT02292537|141726503|SUPERIORITY||Difference in Proportions|1.5|||||TWO_SIDED|95.0|-19.1|22.1|||||Difference in proportions of Nusinersen minus Sham Procedure is based on exact unconditional confidence interval.|||22.10|-19.10|
71110428|NCT01979614|141726512|SUPERIORITY_OR_OTHER||Standard Error|-0.1116||||0.438|TWO_SIDED|95.0|-0.399|0.176|||ANCOVA|||SAP for Global Myocardial Perfusion Reserve Index (MPRI)||0.176|-0.399|0.438
71110429|NCT00756275|141726521|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.33|||<|0.05|TWO_SIDED|95.0|0.91|20.56|||Chi-squared|||||20.56|.91|<0.05
71110430|NCT00756275|141726522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.59|STANDARD_ERROR_OF_MEAN|2.36||0.5|TWO_SIDED|95.0|-6.29|3.11|||t-test, 2 sided|||||3.11|-6.29|.50
71110431|NCT00756275|141726523|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9||||0.3|TWO_SIDED|95.0|0.58|14.5|||Fisher Exact|||||14.50|.58|.30
71110432|NCT00756275|141726524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.98|STANDARD_ERROR_OF_MEAN|8.38||0.34|TWO_SIDED|95.0|-24.64|8.68|||t-test, 2 sided|||||8.68|-24.64|.34
71110433|NCT00756275|141726525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.39|STANDARD_ERROR_OF_MEAN|8.1||0.36|TWO_SIDED|95.0|-8.73|23.52|||t-test, 2 sided|||||23.52|-8.73|.36
71110434|NCT00756275|141726526|SUPERIORITY_OR_OTHER|||||||0.57|||||||Chi-squared|||||||.57
71110435|NCT00756275|141726527|SUPERIORITY_OR_OTHER|||||||0.31|||||||Chi-squared|||||||.31
71110436|NCT00756275|141726528|SUPERIORITY_OR_OTHER|||||||0.72|||||||Chi-squared|||||||.72
71110437|NCT00756275|141726529|SUPERIORITY_OR_OTHER|||||||0.18|||||||Chi-squared|||||||.18
71110438|NCT00756275|141726530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|1.72||0.75|TWO_SIDED|95.0|-3.98|2.87|||t-test, 2 sided|||||2.87|-3.98|.75
71110439|NCT01244035|141726620|OTHER||LS Mean difference|1.1||||0.1325|TWO_SIDED|90.0|-0.54|2.74|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.||||2.74|-0.54|0.1325
71110440|NCT01244035|141726620|OTHER||LS Mean difference|4.16|||<|0.001|TWO_SIDED|90.0|2.53|5.79|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.||||5.79|2.53|<0.001
71110441|NCT01244035|141726620|OTHER||LS Mean difference|-3.06||||0.0016|TWO_SIDED|90.0|-4.7|-1.42|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.||||-1.42|-4.70|0.0016
71110442|NCT01244035|141726621|OTHER||LS Mean difference|-2.94||||0.0212|TWO_SIDED|90.0|-5.3|-0.57|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.||||-0.57|-5.30|0.0212
70852434|NCT02386189|141193492|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_DEVIATION|0.15||0.75|TWO_SIDED||||||t-test, 2 sided|||||||0.75
71110443|NCT01244035|141726621|OTHER||LS Mean difference|-2.76||||0.0299|TWO_SIDED|90.0|-5.16|-0.36|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.||||-0.36|-5.16|0.0299
71110444|NCT01244035|141726621|OTHER||LS Mean difference|-0.18||||0.4506|TWO_SIDED|90.0|-2.54|2.19|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.||||2.19|-2.54|0.4506
71110445|NCT03723980|141726627|SUPERIORITY||Mean Difference (Net)|2.96||||0.329|TWO_SIDED|95.0||||"the calculated p value is for time interval of 4 hours~threshold for statistical significance= \<0.05"|ANOVA|For multiple comparisons between groups, post hoc (LSD) was applied||||||0.329
71110446|NCT03723980|141726627|SUPERIORITY||Mean Difference (Net)|-0.92||||0.764|TWO_SIDED|95.0||||"The calculated p value is for time interval of 12 hours~threshold for statistical significance= \<0.05"|ANOVA|||||||0.764
71062256|NCT01217112|141632536|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.07|STANDARD_ERROR_OF_MEAN|1.532||0.014|TWO_SIDED|90.0|1.44|6.69|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||6.69|1.44|0.014
71062257|NCT01217112|141632536|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.85|STANDARD_ERROR_OF_MEAN|1.4||0.053|TWO_SIDED|90.0|0.45|5.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||5.25|0.45|0.053
71062258|NCT01217112|141632536|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.56|STANDARD_ERROR_OF_MEAN|1.299||0.012|TWO_SIDED|90.0|1.33|5.78|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||5.78|1.33|0.012
71062259|NCT01217112|141632537|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.35|STANDARD_ERROR_OF_MEAN|1.463||0.032|TWO_SIDED|90.0|0.84|5.85|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||5.85|0.84|0.032
71062260|NCT01217112|141632537|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.27|STANDARD_ERROR_OF_MEAN|1.798||0.026|TWO_SIDED|90.0|1.18|7.35|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||7.35|1.18|0.026
71062261|NCT01217112|141632537|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.44|STANDARD_ERROR_OF_MEAN|1.626||0.046|TWO_SIDED|90.0|0.65|6.22|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||6.22|0.65|0.046
71062262|NCT01217112|141632537|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.86|STANDARD_ERROR_OF_MEAN|1.512||0.018|TWO_SIDED|90.0|1.26|6.45|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||6.45|1.26|0.018
71062263|NCT01217112|141632538|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.87|STANDARD_ERROR_OF_MEAN|0.806||0.294|TWO_SIDED|90.0|-0.52|2.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.25|-0.52|0.294
71062264|NCT01217112|141632538|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.74|STANDARD_ERROR_OF_MEAN|0.988||0.092|TWO_SIDED|90.0|0.05|3.43|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.43|0.05|0.092
70936976|NCT01262456|141373761|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.98||||0.0009|TWO_SIDED|95.0|1.32|2.96||A priori threshold for significance was p\<=0.05.|Generalized Estimating Equation (GEE)|GEE Method for 33% responder status at Week 1, Month 1, Month 2, and Month 3, adjusted for age (\<65, ≥65 years), visit, and baseline nocturnal voids.||Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary endpoints in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.||2.96|1.32|0.0009
71062265|NCT01217112|141632538|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.26|STANDARD_ERROR_OF_MEAN|0.893||0.173|TWO_SIDED|90.0|-0.28|2.79|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.79|-0.28|0.173
71062266|NCT01217112|141632538|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.837||0.545|TWO_SIDED|90.0|-0.92|1.95|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.95|-0.92|0.545
71062267|NCT01217112|141632539|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.67|STANDARD_ERROR_OF_MEAN|1.214||0.038|TWO_SIDED|90.0|0.59|4.75|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||4.75|0.59|0.038
71062268|NCT01217112|141632539|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.71|STANDARD_ERROR_OF_MEAN|1.486||0.004|TWO_SIDED|90.0|2.16|7.26|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||7.26|2.16|0.004
70852435|NCT02386189|141193493|SUPERIORITY||Mean Difference (Final Values)|-3.6|STANDARD_DEVIATION|7.1||0.18|TWO_SIDED||||||t-test, 2 sided|||||||0.18
71062269|NCT01217112|141632539|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|1.35||0.088|TWO_SIDED|90.0|0.09|4.72|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||4.72|0.09|0.088
71062270|NCT01217112|141632539|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.54|STANDARD_ERROR_OF_MEAN|1.252||0.01|TWO_SIDED|90.0|1.39|5.68|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||5.68|1.39|0.010
71110447|NCT03723980|141726627|SUPERIORITY||Mean Difference (Net)|-1.57||||0.605|TWO_SIDED|95.0||||"The calculated p value is for time interval of day 2~threshold for statistical significance= \<0.05"|ANOVA|||||||0.605
70852436|NCT02386189|141193494|SUPERIORITY||Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|8.9||0.89|TWO_SIDED||||||t-test, 2 sided|||||||0.89
70936977|NCT01262456|141373762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0029|TWO_SIDED|95.0|-0.57|-0.12||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline nocturnal voids using last observation carried forward.||"Change from baseline in the adjusted mean number of nocturnal voids in the FAS using LOCF.~The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)."||-0.12|-0.57|0.0029
70936978|NCT01262456|141373762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.0128|TWO_SIDED|95.0|-0.52|-0.06||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline nocturnal voids.||"Change from baseline in the adjusted mean number of nocturnal voids in the FAS using LOCF.~The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)."||-0.06|-0.52|0.0128
70936979|NCT01262456|141373763|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.0233|TWO_SIDED|95.0|1.08|3.02||A priori threshold for significance was p\<=0.05.|Regression, Logistic|Logistical regression of 33% responder status adjusted for age (\<65, \>=65) and baseline nocturnal voids using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||3.02|1.08|0.0233
71062271|NCT01217112|141632540|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.53|STANDARD_ERROR_OF_MEAN|1.814||0.064|TWO_SIDED|90.0|0.42|6.64|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||6.64|0.42|0.064
71062272|NCT01217112|141632540|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.55|STANDARD_ERROR_OF_MEAN|2.237||0.008|TWO_SIDED|90.0|2.72|10.38|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||10.38|2.72|0.008
71062273|NCT01217112|141632540|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.65|STANDARD_ERROR_OF_MEAN|2.016||0.084|TWO_SIDED|90.0|0.19|7.1|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||7.10|0.19|0.084
71062274|NCT01217112|141632540|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.05|STANDARD_ERROR_OF_MEAN|1.871||0.041|TWO_SIDED|90.0|0.84|7.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||7.25|0.84|0.041
71062275|NCT01217112|141632541|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.044||0.129|TWO_SIDED|90.0|-0.14|0.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.01|-0.14|0.129
71062276|NCT01217112|141632541|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.051||0.961|TWO_SIDED|90.0|-0.08|0.09|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.09|-0.08|0.961
71110448|NCT03723980|141726627|SUPERIORITY||Mean Difference (Net)|-0.82||||0.786|TWO_SIDED|95.0||||"The calculated p value is for time interval of day 3~threshold for statistical significance= \<0.05"|ANOVA|||||||0.786
71062277|NCT01217112|141632541|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.048||0.128|TWO_SIDED|90.0|-0.16|0.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.01|-0.16|0.128
71062278|NCT01217112|141632541|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.045||0.3|TWO_SIDED|90.0|-0.12|0.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.03|-0.12|0.300
71062279|NCT01217112|141632542|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.65|STANDARD_ERROR_OF_MEAN|5.38||0.625|TWO_SIDED|90.0|-6.37|11.67|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||11.67|-6.37|0.625
71062280|NCT01217112|141632542|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.77|STANDARD_ERROR_OF_MEAN|5.519||0.226|TWO_SIDED|90.0|-2.48|16.02|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||16.02|-2.48|0.226
71062281|NCT01217112|141632542|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|5.103||0.904|TWO_SIDED|90.0|-7.94|9.18|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||9.18|-7.94|0.904
71062282|NCT01217112|141632542|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.17|STANDARD_ERROR_OF_MEAN|5.71||0.285|TWO_SIDED|90.0|-3.41|15.75|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||15.75|-3.41|0.285
71062283|NCT01217112|141632543|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.568||0.138|TWO_SIDED|90.0|-1.81|0.1|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.10|-1.81|0.138
71062284|NCT01217112|141632543|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.547||0.505|TWO_SIDED|90.0|-1.28|0.55|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.55|-1.28|0.505
70936980|NCT01262456|141373763|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72||||0.0386|TWO_SIDED|95.0|1.03|2.87||A priori threshold for significance was p\<=0.05.|Regression, Logistic|Logistical regression of 33% responder status adjusted for age (\<65, \>=65) and baseline nocturnal voids using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||2.87|1.03|0.0386
70936981|NCT01262456|141373764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.76||||0.0026|TWO_SIDED|95.0|15.02|70.51||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline time to first nocturnal void using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||70.51|15.02|0.0026
70936982|NCT01262456|141373764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.95||||0.0064|TWO_SIDED|95.0|11.03|66.88||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline time to first nocturnal void using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||66.88|11.03|0.0064
70941742|NCT04748445|141383935|OTHER||Slope|-0.001326|STANDARD_ERROR_OF_MEAN|7.555||0.0816|TWO_SIDED|90.0|-0.002578|-0.0000744|||Mixed Models Analysis|||MM\_MFCC 1st order delta 05 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0000744|-0.002578|0.0816
71062285|NCT01217112|141632543|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.54||0.743|TWO_SIDED|90.0|-0.73|1.08|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.08|-0.73|0.743
71062286|NCT01217112|141632543|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.565||0.54|TWO_SIDED|90.0|-0.6|1.29|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.29|-0.60|0.540
71062287|NCT01217112|141632545|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|1.664||0.701|TWO_SIDED|90.0|-2.14|3.43|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.43|-2.14|0.701
71062288|NCT01217112|141632545|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.77|STANDARD_ERROR_OF_MEAN|1.662||0.006|TWO_SIDED|90.0|1.99|7.55|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||7.55|1.99|0.006
71062289|NCT01217112|141632545|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.98|STANDARD_ERROR_OF_MEAN|1.589||0.542|TWO_SIDED|90.0|-1.68|3.64|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.64|-1.68|0.542
71062290|NCT01217112|141632545|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|1.627||0.827|TWO_SIDED|90.0|-2.36|3.08|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.08|-2.36|0.827
71062291|NCT03192488|141632546|SUPERIORITY||Mean Difference (Final Values)|1.06||||0.047|TWO_SIDED|95.0|0.01|2.11|||ANOVA|"The overall model was adjusted for the co-variate VO2max."||||2.11|0.01|0.047
71062292|NCT03192488|141632547|SUPERIORITY|||||||0.327|||||||ANOVA|||||||0.327
71062293|NCT03192488|141632547|SUPERIORITY|||||||0.557|||||||ANOVA|||||||0.557
71062294|NCT00572936|141632580|EQUIVALENCE|ANOVA was performed to compare the results between the three interventions.|||||<|0.05||||||threshold for significance was \<0.05|ANOVA|||||||<.05
71110449|NCT03723980|141726627|SUPERIORITY||Mean Difference (Net)|-0.72||||0.813|TWO_SIDED|95.0||||"The calculated p value is for time interval of day 4~threshold for statistical significance= \<0.05"|ANOVA|||||||0.813
71110450|NCT03723980|141726629|OTHER||Mean Difference (Net)|2.97|STANDARD_ERROR_OF_MEAN|3.0||0.334|TWO_SIDED|95.0||||"The calculated p value is for the difference between pre-operative time interval and 4 hours time interval.~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.334
71062295|NCT00572936|141632581|EQUIVALENCE|ANOVA was performed to compare the results between the three interventions.|||||<|0.05||||||threshold for statistical significance was \<0.05|ANOVA|||||||<0.05
71062296|NCT00572936|141632582|EQUIVALENCE|ANOVA was performed to compare the results between the three interventions.||||||0.93||||||threshold for statistical significance was \<0.05|ANOVA|||||||0.93
71062297|NCT00572936|141632583|EQUIVALENCE|ANOVA was performed to compare the results between the three interventions.||||||0.84||||||threshold for statistical significance was \<0.05|ANOVA|||||||0.84
71062298|NCT00572936|141632584|EQUIVALENCE|ANOVA was performed to compare the results between the three interventions.|||||<|0.05||||||threshold for statistical significance was \<0.05|ANOVA|||||||<0.05
71062299|NCT00572936|141632585|EQUIVALENCE|ANOVA was performed to compare the results between the three interventions.||||||0.89||||||threshold for statistical significance was \<0.05|ANOVA|||||||0.89
71062300|NCT00572936|141632586|EQUIVALENCE|Kruskal-Wallis test was used to compare the differences between outflow facility for the three interventions|||||<|0.05||||||threshold for statistical significance was \<0.05|Kruskal-Wallis|||||||<0.05
71110451|NCT03723980|141726629|OTHER||Mean Difference (Net)|2.33|STANDARD_ERROR_OF_MEAN|3.0||0.448|TWO_SIDED|95.0||||"The calculated p value is for the difference between time interval of 4 hours and time interval of 12 hours.~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.448
71110452|NCT03723980|141726629|OTHER||Mean Difference (Net)|5.88|STANDARD_ERROR_OF_MEAN|3.0||0.056|TWO_SIDED|95.0||||"The calculated p value is for the difference between time intervals of 12 hours and day 2~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.056
71062301|NCT00572936|141632587|EQUIVALENCE|Kruskal-Wallis test was used to compare the differences in uveoscleral outflow between the three interventions|||||<|0.05||||||threshold for statistical analysis was \<0.05|Kruskal-Wallis|||||||<0.05
70852437|NCT01147627|141193522|NON_INFERIORITY_OR_EQUIVALENCE|108 patients in each group was needed to provide 90% power to detect non-inferiority of exenatide, shown by a mean difference of 0.4% in HbA1c change from baseline.|||||<|0.05||95.0|||||ANCOVA|||||||<0.05
71062302|NCT02547428|141632588|SUPERIORITY||Treatment difference|-8.1|STANDARD_ERROR_OF_MEAN|1.48|<|0.001|TWO_SIDED|95.0|-11.0|-5.1|||ANCOVA||Sample size of 60 participants (30 per treatment sequence) was needed to provide minimum 85% power to detect 5 point difference between treatments at a 2-sided significance level of 5% using a paired t-test.|Null hypothesis was that there was no difference in ADHD-RS-IV total score change from Baseline between CTN SR and placebo. The analysis of covariance (ANCOVA) model included terms for period, sequence, and treatment as fixed effects, and Baseline score as a covariate, and a participate-within-sequence term as a random effect.||-5.1|-11.0|<0.001
71062303|NCT02547428|141632589|SUPERIORITY||Treatment difference|-7.1|STANDARD_ERROR_OF_MEAN|1.74|<|0.001|TWO_SIDED|95.0|-10.7|-3.6|||ANCOVA|||Null hypothesis was that there was no difference in ADHD-RS-IV total score change from Baseline between CTN SR 400 mg/day and placebo.||-3.6|-10.7|<0.001
71062304|NCT01479465|141632610|SUPERIORITY||Hazard Ratio (HR)|1.45||||0.0395|TWO_SIDED|95.0|1.01|2.06|||Log Rank|||"The null hypothesis was that the hazard ratio (HR) equals to 1 between SIM treatment arm and placebo, while the alternative hypothesis was that HR was less than 1.~The HR (95% confidence interval \[CI\]) and p-value (for comparison between SIM treatment arm and placebo) were based on two-sided log-rank test, stratified based on the 2-level Eastern Cooperative Oncology Group (ECOG) performance status (0 or \> 0) at randomization."||2.06|1.01|0.0395
71062305|NCT01479465|141632610|SUPERIORITY||Hazard Ratio (HR)|1.32||||0.1042|TWO_SIDED|95.0|0.92|1.89|||Log Rank|||"The null hypothesis was that the HR equals to 1 between SIM treatment arm and placebo, while the alternative hypothesis was that HR was less than 1.~The HR (95% CI) and p-value (for comparison between SIM treatment arm and placebo) were based on two-sided log-rank test, stratified based on the 2-level ECOG performance status (0 or \> 0) at randomization."||1.89|0.92|0.1042
71062306|NCT01366417|141632652|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.21|STANDARD_ERROR_OF_MEAN|0.133|<|0.05|TWO_SIDED|95.0|1.95|2.48|||ANOVA|||Hypothesis: ChloraPrep will meet or exceed the 1.0 log reduction in colony forming units/cm\^2 at 30 seconds after application.||2.48|1.95|< 0.05
71062307|NCT01366417|141632652|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.25|STANDARD_DEVIATION|0.133|<|0.05|TWO_SIDED|95.0|1.99|2.51|||ANOVA|||hypothesis: 70% Isopropyl Alcohol will meet or exceed 1.0 log 10 colony forming units / cm\^2 at 30 seconds after treatment||2.51|1.99|<0.05
71062308|NCT01366417|141632653|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.65|STANDARD_DEVIATION|0.133|<|0.05|TWO_SIDED|95.0|2.39|2.91|||ANOVA|||Hypothesis: ChloraPrep One Step will meet or exceed 2.0 log 10 reduction at 10 minutes after treatment.||2.91|2.39|<0.05
71062309|NCT01366417|141632653|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.6|STANDARD_DEVIATION|0.133|<|0.05|TWO_SIDED|95.0|2.33|2.86|||ANOVA|||Hypothesis: 70% Isopropyl Alcohol will meet or exceed 2.0 log 10 reduction at 10 minutes after treatment||2.86|2.33|<0.05
71062310|NCT01641640|141632654|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Binomial exact test|||Superiority would be demonstrated if the SVR12 rate was higher than the 60% null SVR rate based on historical control data.||||< 0.001
70852438|NCT01024309|141193565|SUPERIORITY_OR_OTHER|||||||0.04||||||Apriori level of significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum was used||||||.04
70852439|NCT01024309|141193566|SUPERIORITY_OR_OTHER|||||||0.08||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test||||||0.08
70852440|NCT01024309|141193567|SUPERIORITY_OR_OTHER|||||||0.04||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test was used||||||0.04
70941743|NCT04748445|141383935|OTHER||Slope|0.0005502|STANDARD_ERROR_OF_MEAN|1.056||0.6034|TWO_SIDED|90.0|-0.0012|0.002301|||Mixed Models Analysis|||MM\_MFCC 1st order delta 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.002301|-0.001200|0.6034
71062311|NCT01234350|141632660|OTHER||IRR|0.829||||0.4007|TWO_SIDED|95.0|0.536|1.283||Poisson-mixture regression was used to model the influence of age, stage of disease, and relevant medical history along with the treatment group effect on the number of events adjusted for individual study exposures measured in 100 PYE.|Wald test|The IRs for each treatment arm with 95% confidence interval (CI), and incidence rate ratio (IRRs) with 95% CI and p-values were based on Wald test.|IRR for treatment with the lower 95% confidence limit \>1 suggest increased risk of AESI; upper confidence limit \<1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.|The IRs were estimated using a Poisson-mixture regression model.||1.283|0.536|0.4007
71078037|NCT01026818|141664569|SUPERIORITY_OR_OTHER||LS Mean Differences|0.09|STANDARD_ERROR_OF_MEAN|0.38||0.821|TWO_SIDED|95.0|-0.67|0.84||P-value is for orgasmic function - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.84|-0.67|0.821
71078038|NCT01026818|141664569|SUPERIORITY_OR_OTHER||LS Mean Differences|0.46|STANDARD_ERROR_OF_MEAN|0.42||0.268|TWO_SIDED|95.0|-0.36|1.28||P-value is for orgasmic function - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.28|-0.36|0.268
71078039|NCT01026818|141664569|SUPERIORITY_OR_OTHER||LS Mean Differences|0.0|STANDARD_ERROR_OF_MEAN|0.41||0.998|TWO_SIDED|95.0|-0.8|0.8||P-value is for orgasmic function - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.80|-0.80|0.998
71078040|NCT01026818|141664569|SUPERIORITY_OR_OTHER||LS Mean Differences|0.15|STANDARD_ERROR_OF_MEAN|0.42||0.728|TWO_SIDED|95.0|-0.68|0.97||P-value is for orgasmic function - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.97|-0.68|0.728
71078041|NCT01026818|141664569|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.52|STANDARD_ERROR_OF_MEAN|0.41||0.203|TWO_SIDED|95.0|-1.33|0.28||P-value is for orgasmic function - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.28|-1.33|0.203
70936983|NCT01262456|141373765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-86.17||||0.0034|TWO_SIDED|95.0|-143.69|-28.64||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline nocturnal urine volume using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||-28.64|-143.69|0.0034
70936984|NCT01262456|141373765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-77.8||||0.0086|TWO_SIDED|95.0|-135.7|-19.89||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline nocturnal urine volume using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||-19.89|-135.70|0.0086
70936985|NCT01262456|141373766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-45.31||||0.4126|TWO_SIDED|95.0|-153.94|63.32||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline 24-hour urine volume using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||63.32|-153.94|0.4126
70936986|NCT01262456|141373766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.79||||0.7353|TWO_SIDED|95.0|-127.99|90.41||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline 24-hour urine volume using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||90.41|-127.99|0.7353
71062312|NCT01234350|141632661|OTHER||IRR|0.874||||0.671|TWO_SIDED|95.0|0.47|1.626||Poisson-mixture regression was used to model the influence of age, stage of disease, and relevant medical history along with the treatment group effect on the number of events adjusted for individual study exposures measured in 100 PYE.|Wald test|The IRs for each treatment arm with 95% CI, and IRRs with 95% CI and p-values were based on Wald test.|IRR for treatment with the lower 95% confidence limit \>1 suggest increased risk of AESI; upper confidence limit \<1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.|For osteoporosis and osteopenia events. The IRs were estimated using Poisson-mixture regression model.||1.626|0.470|0.6710
71078042|NCT01026818|141664569|SUPERIORITY_OR_OTHER||LS Mean Differences|0.02|STANDARD_ERROR_OF_MEAN|0.24||0.95|TWO_SIDED|95.0|-0.46|0.49||P-value is for sexual desire - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.49|-0.46|0.950
71078043|NCT01026818|141664569|SUPERIORITY_OR_OTHER||LS Mean Differences|0.01|STANDARD_ERROR_OF_MEAN|0.24||0.95|TWO_SIDED|95.0|-0.45|0.48||P-value is for sexual desire - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.48|-0.45|0.950
71078044|NCT01026818|141664569|SUPERIORITY_OR_OTHER||LS Mean Differences|0.06|STANDARD_ERROR_OF_MEAN|0.23||0.792|TWO_SIDED|95.0|-0.39|0.51||P-value is for sexual desire - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.51|-0.39|0.792
71078045|NCT01026818|141664569|SUPERIORITY_OR_OTHER||LS Mean Differences|0.11|STANDARD_ERROR_OF_MEAN|0.23||0.631|TWO_SIDED|95.0|-0.34|0.55||P-value is for sexual desire - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.55|-0.34|0.631
71078046|NCT01026818|141664569|SUPERIORITY_OR_OTHER||LS Mean Differences|0.1|STANDARD_ERROR_OF_MEAN|0.24||0.691|TWO_SIDED|95.0|-0.38|0.58||P-value is for sexual desire - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.58|-0.38|0.691
71078047|NCT01026818|141664569|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.06|STANDARD_ERROR_OF_MEAN|0.24||0.801|TWO_SIDED|95.0|-0.53|0.41||P-value is for sexual desire - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.41|-0.53|0.801
71078048|NCT01026818|141664569|SUPERIORITY_OR_OTHER||LS Mean Differences|0.93|STANDARD_ERROR_OF_MEAN|0.5||0.065|TWO_SIDED|95.0|-0.06|1.92||P-value is for intercourse satisfaction - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.92|-0.06|0.065
71078049|NCT01026818|141664569|SUPERIORITY_OR_OTHER||LS Mean Differences|0.54|STANDARD_ERROR_OF_MEAN|0.49||0.274|TWO_SIDED|95.0|-0.43|1.51||P-value is for intercourse satisfaction - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.51|-0.43|0.274
71078050|NCT01026818|141664569|SUPERIORITY_OR_OTHER||LS Mean Differences|0.48|STANDARD_ERROR_OF_MEAN|0.53||0.359|TWO_SIDED|95.0|-0.55|1.52||P-value is for intercourse satisfaction - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.52|-0.55|0.359
71078051|NCT01026818|141664569|SUPERIORITY_OR_OTHER||LS Mean Differences|0.09|STANDARD_ERROR_OF_MEAN|0.52||0.863|TWO_SIDED|95.0|-0.93|1.11||P-value is for intercourse satisfaction - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.11|-0.93|0.863
71078052|NCT01026818|141664569|SUPERIORITY_OR_OTHER||LS Mean Differences|0.56|STANDARD_ERROR_OF_MEAN|0.56||0.314|TWO_SIDED|95.0|-0.53|1.66||P-value is for intercourse satisfaction - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.66|-0.53|0.314
71078053|NCT01026818|141664569|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.06|STANDARD_ERROR_OF_MEAN|0.54||0.91|TWO_SIDED|95.0|-1.13|1.01||P-value is for intercourse satisfaction - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.01|-1.13|0.910
71110453|NCT03723980|141726629|OTHER||Mean Difference (Net)|0.94|STANDARD_ERROR_OF_MEAN|3.0||0.76|TWO_SIDED|95.0||||"The calculated p value is for the difference between time intervals of day 2 and day 3~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.760
71110454|NCT03723980|141726629|OTHER||Mean Difference (Net)|0.67|STANDARD_ERROR_OF_MEAN|3.0||0.828|TWO_SIDED|95.0||||"The calculated p value is for the difference between time intervals of day 3 and day 4~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.828
71110455|NCT03723980|141726629|OTHER||Mean Difference (Net)|11.8|STANDARD_ERROR_OF_MEAN|2.9||0|TWO_SIDED|95.0||||"The calculated p value is for the difference between pre-operative time interval and 4 hours time interval~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.000
71110456|NCT03723980|141726629|OTHER||Mean Difference (Net)|-1.54|STANDARD_ERROR_OF_MEAN|2.9||0.605|TWO_SIDED|95.0||||"The calculated p value is for the difference between time interval of 4 hours and time interval of 12 hours~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.605
71110457|NCT03723980|141726629|OTHER||Mean Difference (Net)|5.23|STANDARD_ERROR_OF_MEAN|2.9||0.8|TWO_SIDED|95.0||||"The calculated p value is for the difference between time intervals of 12 hours and day 2~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.80
70941744|NCT04748445|141383935|OTHER||Slope|-0.0004691|STANDARD_ERROR_OF_MEAN|7.305||0.522|TWO_SIDED|90.0|-0.00168|0.0007415|||Mixed Models Analysis|||MM\_MFCC 1st order delta 07 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0007415|-0.001680|0.5220
71062313|NCT01234350|141632661|OTHER||IRR|1.857||||0.4544|TWO_SIDED|95.0|0.367|9.403||Poisson-mixture regression was used to model the influence of age, stage of disease, and relevant medical history along with the treatment group effect on the number of events adjusted for individual study exposures measured in 100 PYE.|Wald test|The IRs for each treatment arm with 95% CI, and IRRs with 95% CI and p-values were based on Wald test.|IRR for treatment with the lower 95% confidence limit \>1 suggest increased risk of AESI; upper confidence limit \<1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.|For bone fracture events. The IRs were estimated using Poisson-mixture regression model.||9.403|0.367|0.4544
71062314|NCT01234350|141632662|OTHER||IRR|1.193||||0.2529|TWO_SIDED|95.0|0.882|1.613||Poisson mixture regression was used to model the influence of age, stage of disease, and history of diabetes mellitus along with the treatment group effect on the number of events adjusted for individual study exposures measured in 100 PYE.|Wald test|The IRs for each treatment arm with 95% CI, and IRRs with 95% CI and p-values were based on Wald test.|IRR for treatment with the lower 95% confidence limit \>1 suggest increased risk of AESI; upper confidence limit \<1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.|For glucose intolerance. The IRs were estimated using Poisson-mixture regression model.||1.613|0.882|0.2529
71110458|NCT03723980|141726629|OTHER||Mean Difference (Net)|1.69|STANDARD_ERROR_OF_MEAN|2.9||0.574|TWO_SIDED|95.0||||"The calculated p value is for the difference between time intervals of day 2 and day 3~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.574
71110459|NCT03723980|141726629|OTHER||Mean Difference (Net)|0.77|STANDARD_ERROR_OF_MEAN|2.9||0.796|TWO_SIDED|95.0||||"The calculated p value is for the difference between time intervals of day 3 and day 4~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.796
71110460|NCT03723980|141726630|OTHER||Mean Difference (Net)|-0.6||||0.412|TWO_SIDED|||||"The p-value calculated is for pain score difference at 4 hours~Threshold for statistical significance= \<0.05"|Wilcoxon (Mann-Whitney)|||||||0.412
71110461|NCT03723980|141726630|OTHER||Mean Difference (Net)|2.8||||0.94|TWO_SIDED|||||"The p-value calculated is for pain score difference at 12 hours~Threshold for statistical significance= \<0.05"|Wilcoxon (Mann-Whitney)|||||||0.94
71110462|NCT03723980|141726630|OTHER||Mean Difference (Net)|5.5||||0.035|TWO_SIDED|||||"The p-value calculated is for pain score difference at Day 2~Threshold for statistical significance= \<0.05"|Wilcoxon (Mann-Whitney)|||||||0.035
71110463|NCT03723980|141726630|OTHER||Mean Difference (Net)|4.4||||0.023|TWO_SIDED|||||"The p-value calculated is for pain score difference at Day 3~Threshold for statistical significance= \<0.05"|Wilcoxon (Mann-Whitney)|||||||0.023
71110464|NCT03723980|141726630|OTHER||Median Difference (Net)|4.3||||0.02|TWO_SIDED|||||"The p-value calculated is for pain score difference at Day 4.~Threshold for statistical significance= \<0.05"|Wilcoxon (Mann-Whitney)|||||||0.020
71110465|NCT03723980|141726631|OTHER|||||||0.15||||||"The p-value calculated is for pain score difference at 4 hours~Threshold for statistical significance= \<0.05"|Kruskal-Wallis|||||||0.15
71110466|NCT03723980|141726631|OTHER|||||||0.36||||||"The p-value calculated is for pain score difference at 12 hours~Threshold for statistical significance= \<0.05"|Kruskal-Wallis|||||||0.36
71110467|NCT03723980|141726631|OTHER|||||||0.13||||||"The p-value calculated is for pain score difference at day 2~Threshold for statistical significance= \<0.05"|Kruskal-Wallis|||||||0.13
70941745|NCT04748445|141383935|OTHER||Slope|-0.00153|STANDARD_ERROR_OF_MEAN|7.82||0.0526|TWO_SIDED|90.0|-0.002826|-0.0002344|||Mixed Models Analysis|||MM\_MFCC 1st order delta 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0002344|-0.002826|0.0526
71110468|NCT03723980|141726631|OTHER|||||||0.55||||||"The p-value calculated is for pain score difference at day 3~Threshold for statistical significance= \<0.05"|Kruskal-Wallis|||||||0.55
71110469|NCT03723980|141726631|OTHER|||||||0.17||||||"The p-value calculated is for pain score difference at day 4~Threshold for statistical significance= \<0.05"|Kruskal-Wallis|||||||0.17
71110470|NCT04512001|141726636|EQUIVALENCE|Margins for results to be considered equivalent: -0.6 to 0.5.|Least squares means difference|0.01|||||TWO_SIDED|90.0|-0.16|0.18||||||||0.18|-0.16|
71110471|NCT04512001|141726638|EQUIVALENCE|Margins for results to be considered equivalent: -15%, 15%.|Difference in % Response Rate|-3.94|||||TWO_SIDED|95.0|-9.97|2.11||||||||2.11|-9.97|
71110472|NCT03198767|141726648|SUPERIORITY||Ratio of number of events|0.71||||0.202|TWO_SIDED|80.0|0.5|1.0|||Mixed Models Analysis|||Day 3||1.00|0.50|0.202
71110473|NCT03198767|141726648|SUPERIORITY||Ratio of number of events|0.21|||<|0.001|TWO_SIDED|80.0|0.14|0.32|||Mixed Models Analysis|||Day 3||0.32|0.14|<0.001
71110474|NCT03198767|141726648|SUPERIORITY||Ratio of number of events|0.3|||<|0.001|TWO_SIDED|80.0|0.19|0.46|||Mixed Models Analysis|||Day 3||0.46|0.19|<0.001
71110475|NCT03198767|141726648|SUPERIORITY||Ratio of number of events|0.79||||0.275|TWO_SIDED|80.0|0.6|1.04|||Mixed Models Analysis|||Day 3||1.04|0.60|0.275
71062315|NCT01234350|141632662|OTHER||IRR|2.623||||0.0208|TWO_SIDED|95.0|1.158|5.944||Poisson-mixture regression is used to model the influence of age, stage of disease, and relevant medical history along with the treatment group effect on the number of events adjusted for individual trial exposures measured in 100 PYE.|Wald test|The IRs for each treatment arm with 95% CI, and IRRs with 95% CI and p-values were based on Wald test.|IRR for treatment with the lower 95% confidence limit \>1 suggest increased risk of AESI; upper confidence limit \<1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.|For T2DM. The IRs were estimated using Poisson-mixture regression model.||5.944|1.158|0.0208
71062316|NCT01234350|141632669|OTHER||Odds Ratio (OR)|0.747||||0.0821|TWO_SIDED|95.0|0.537|1.038||A logistic regression was used to model the influence of age, stage of disease and relevant medical history along with the treatment group on the time to event for all-cause mortality.|Regression, Logistic|Logistic regression was used to model the influence of age, stage of disease and relevant medical history along with the treatment group.||The analyses of all-cause mortality was based on logistic regressions.||1.038|0.537|0.0821
71062317|NCT01839708|141632670|OTHER||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71062318|NCT01839708|141632671|OTHER||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71062319|NCT01839708|141632672|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71062320|NCT01839708|141632673|OTHER||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71062321|NCT01839708|141632674|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71062322|NCT01839708|141632675|OTHER|||||||0.03|||||||Mixed Models Analysis|||||||0.03
71062323|NCT01839708|141632676|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71062324|NCT01839708|141632677|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71062325|NCT01839708|141632678|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
70852441|NCT01024309|141193568|SUPERIORITY_OR_OTHER|||||||0.22||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test was used||||||0.22
70941746|NCT04748445|141383935|OTHER||Slope|0.0004166|STANDARD_ERROR_OF_MEAN|7.294||0.5689|TWO_SIDED|90.0|-0.000792|0.001625|||Mixed Models Analysis|||MM\_MFCC 1st order delta 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001625|-0.0007920|0.5689
70941747|NCT04748445|141383935|OTHER||Slope|-0.002112|STANDARD_ERROR_OF_MEAN|7.299||0.0045|TWO_SIDED|90.0|-0.003321|-0.000902|||Mixed Models Analysis|||MM\_MFCC 1st order delta 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0009020|-0.003321|0.0045
71062326|NCT01839708|141632679|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71062327|NCT01839708|141632680|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71062328|NCT01839708|141632681|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71062329|NCT01839708|141632682|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71062330|NCT01839708|141632683|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71062331|NCT01836471|141632684|SUPERIORITY_OR_OTHER||least squares mean|0.01|STANDARD_ERROR_OF_MEAN|0.038||0.7269|TWO_SIDED|90.0|-0.5|0.08|||Mixed Models Analysis|||||0.08|-0.5|0.7269
71062332|NCT01836471|141632685|SUPERIORITY_OR_OTHER||least sqares mean|0.01|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|90.0|-0.08|0.09||||||||0.09|-0.08|
71062333|NCT01836471|141632685|SUPERIORITY_OR_OTHER||least squares mean|0.04|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|90.0|-0.04|0.13||||||||0.13|-0.04|
71062334|NCT01836471|141632685|SUPERIORITY_OR_OTHER||least squares mean|-0.04|STANDARD_ERROR_OF_MEAN|0.053|||TWO_SIDED|90.0|-0.13|0.05||||||||0.05|-0.13|
71062335|NCT01836471|141632686|SUPERIORITY_OR_OTHER|||||||0.9179|||||||Mixed Models Analysis|||||||0.9179
71062336|NCT01836471|141632687|SUPERIORITY_OR_OTHER||least squares mean|-0.02|STANDARD_ERROR_OF_MEAN|0.098|||TWO_SIDED|95.0|-0.22|0.17||||||||0.17|-0.22|
71062337|NCT01836471|141632687|SUPERIORITY_OR_OTHER||least sqares mean|-0.07|STANDARD_ERROR_OF_MEAN|0.128|||TWO_SIDED|95.0|-0.32|0.19||||||||0.19|-0.32|
71062338|NCT01836471|141632687|SUPERIORITY_OR_OTHER||least squares mean|0.1|STANDARD_ERROR_OF_MEAN|0.134|||TWO_SIDED|95.0|-0.16|0.37||||||||0.37|-0.16|
71062339|NCT01836471|141632687|SUPERIORITY_OR_OTHER||least squares mean|-0.17|STANDARD_ERROR_OF_MEAN|0.134|||TWO_SIDED|95.0|-0.43|0.09||||||||0.09|-0.43|
71062340|NCT01836471|141632688|SUPERIORITY_OR_OTHER|||||||0.793|||||||Mixed Models Analysis|||||||0.7930
71062341|NCT03051100|141632710|SUPERIORITY||Least squares mean difference|-60.5|STANDARD_ERROR_OF_MEAN|3.67|<|0.001|TWO_SIDED|95.0|-68.0|-53.0|||ANCOVA||Triplet therapy minus placebo|||-53.0|-68.0|<0.001
71062342|NCT03051100|141632711|SUPERIORITY||Least squares mean difference|-58.7|STANDARD_ERROR_OF_MEAN|3.02|<|0.001|TWO_SIDED|95.0|-64.9|-52.6|||ANCOVA||Triplet therapy minus placebo|non-HDL-C||-52.6|-64.9|<0.001
71062343|NCT03051100|141632711|SUPERIORITY||Least squares mean difference|-46.0|STANDARD_ERROR_OF_MEAN|2.77|<|0.001|TWO_SIDED|95.0|-51.6|-40.4|||ANCOVA||Triplet therapy minus placebo|TC||-40.4|-51.6|<0.001
70852442|NCT01024309|141193569|SUPERIORITY_OR_OTHER|||||||0.0029||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test was used||||||.0029
71062344|NCT03051100|141632711|SUPERIORITY||Least squares mean difference|-54.1|STANDARD_ERROR_OF_MEAN|2.74|<|0.001|TWO_SIDED|95.0|-59.7|-48.6|||ANCOVA|||apoB||-48.6|-59.7|<0.001
71062345|NCT03051100|141632711|SUPERIORITY||Least squares mean difference|-36.3|STANDARD_ERROR_OF_MEAN|6.58|<|0.001|TWO_SIDED|95.0|-49.7|-22.8|||ANCOVA|||TG||-22.8|-49.7|<0.001
71062346|NCT03051100|141632711|SUPERIORITY||Least squares mean difference|-1.5|STANDARD_ERROR_OF_MEAN|2.7|=|0.588|TWO_SIDED|95.0|-7.0|4.0|||ANCOVA|||HDL-C||4.0|-7.0|=0.588
71062347|NCT03051100|141632712|SUPERIORITY||Median treatment difference|-41.9|STANDARD_ERROR_OF_MEAN|9.86|<|0.001|TWO_SIDED|95.0|-60.0|-21.4|||Wilcoxon rank sum test|||||-21.4|-60.0|<0.001
71062348|NCT03051100|141632713|SUPERIORITY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
71062349|NCT03051100|141632714|SUPERIORITY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
71078054|NCT01026818|141664569|SUPERIORITY_OR_OTHER||LS Mean Differences|0.19|STANDARD_ERROR_OF_MEAN|0.3||0.532|TWO_SIDED|95.0|-0.4|0.78||P-value is for overall satisfaction - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.78|-0.40|0.532
71110476|NCT03198767|141726648|SUPERIORITY||Ratio of number of events|0.78||||0.234|TWO_SIDED|80.0|0.59|1.02|||Mixed Models Analysis|||Day 3||1.02|0.59|0.234
70936987|NCT03652610|141373780|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% CI for the hSBA GMT ratio for serogroup A is \> 0.5|GMT ratio|0.88|||||TWO_SIDED|95.0|0.64|1.2|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and country as factors.||To demonstrate non-inferiority of the investigational MenACWY liquid vaccine with approximately 30% Men A FS (GSK3536820A ACWY\_Liq Group) to that of currently licensed MenACWY vaccine (ACWY Group), as measured by the adjusted human serum bactericidal assay (hSBA) Geometric Mean Titers (GMTs) directed against N. meningitidis serogroup A at Day 29 after a single dose vaccination||1.20|0.64|
70936988|NCT03652610|141373781|OTHER||GMT ratio|1.19|||||TWO_SIDED|95.0|0.84|1.68|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and country as factors.||To compare the immunogenicity of the investigational MenACWY liquid vaccine with approximately 30% Men A FS (GSK3536820A ACWY\_Liq Group) and the currently licensed MenACWY vaccine (ACWY Group), as measured by the adjusted hSBA GMTs directed against N. meningitidis serogroup C at Day 29||1.68|0.84|
70936989|NCT03652610|141373781|OTHER||GMT ratio|1.23|||||TWO_SIDED|95.0|0.96|1.58|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and country as factors.||To compare the immunogenicity of the investigational MenACWY liquid vaccine with approximately 30% Men A FS (GSK3536820A ACWY\_Liq Group) and the currently licensed MenACWY vaccine (ACWY Group), as measured by the adjusted hSBA GMTs directed against N. meningitidis serogroup W at Day 29||1.58|0.96|
70936990|NCT03652610|141373781|OTHER||GMT ratio|1.19|||||TWO_SIDED|95.0|0.9|1.58|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and country as factors.||To compare the immunogenicity of the investigational MenACWY liquid vaccine with approximately 30% Men A FS (GSK3536820A ACWY\_Liq Group) and the currently licensed MenACWY vaccine (ACWY Group), as measured by the adjusted hSBA GMTs directed against N. meningitidis serogroup Y at Day 29||1.58|0.90|
70936991|NCT03652610|141373783|OTHER||Difference in percentage of subjects|-3.87|||||TWO_SIDED|95.0|-9.3|1.52|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup A at Day 29.||1.52|-9.30|
71062350|NCT05921903|141632723|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|3.52|||||TWO_SIDED|95.0|2.26|5.48|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/Pooled RSV\_IC) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant (Pooled RSV\_IC group) and healthy participants (RSV\_HA group) for the RSV-A strain at Visit 2.||5.48|2.26|
71062351|NCT05921903|141632723|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.62|||||TWO_SIDED|95.0|1.28|2.04|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/Pooled RSV\_IC) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant (Pooled RSV\_IC group) and healthy participants (RSV\_HA group) for the RSV-A strain at Visit 3.||2.04|1.28|
71062352|NCT05921903|141632724|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.26|||||TWO_SIDED|95.0|0.94|1.69|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_IC\_2/RSV\_IC\_1) (ANCOVA model applied to the log10- transformed titers). ANCOVA model included the group as fixed effect, and SOT type and baseline log10-transformed titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 1 dose of vaccine (RSV\_IC\_1 group) and participants that received lung or kidney solid organ transplant and 2 doses of vaccine (RSV\_IC\_2 group) for the RSV-A strain at Visit 4.||1.69|0.94|
71062353|NCT05921903|141632725|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.31|||||TWO_SIDED|95.0|1.01|1.68|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/RSV\_IC\_1) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 1 dose of study intervention (RSV\_IC\_1 group) and healthy participants (RSV\_HA group) for the RSV-A strain at Visit 4.||1.68|1.01|
71062354|NCT05921903|141632726|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.8|1.3|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/RSV\_IC\_2) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 2 doses of study intervention (RSV\_IC\_2 group) and healthy participants (RSV\_HA group) for the RSV-A strain at Visit 4.||1.30|0.80|
71078055|NCT01026818|141664569|SUPERIORITY_OR_OTHER||LS Mean Differences|0.15|STANDARD_ERROR_OF_MEAN|0.3||0.62|TWO_SIDED|95.0|-0.43|0.73||P-value is for overall satisfaction - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.73|-0.43|0.620
70936992|NCT03652610|141373783|OTHER||Difference in percentage of subjects|1.87|||||TWO_SIDED|95.0|-4.7|8.43|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup C at Day 29.||8.43|-4.70|
71110477|NCT03198767|141726648|SUPERIORITY||Ratio of number of events|0.98||||0.921|TWO_SIDED|80.0|0.73|1.3|||Mixed Models Analysis|||Day 3||1.30|0.73|0.921
71110478|NCT03198767|141726649|SUPERIORITY||Ratio of number of events|0.68||||0.04|TWO_SIDED|80.0|0.54|0.86|||Mixed Models Analysis|||||0.86|0.54|0.040
70852443|NCT01024309|141193570|SUPERIORITY_OR_OTHER|||||||0.13||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test was used||||||0.13
71062355|NCT05921903|141632728|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|3.37|||||TWO_SIDED|95.0|2.28|4.98|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/Pooled RSV\_IC) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant (Pooled RSV\_IC group) and healthy participants (RSV\_HA group) for the RSV-B strain at Visit 2.||4.98|2.28|
71062356|NCT05921903|141632728|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.67|||||TWO_SIDED|95.0|1.32|2.13|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/Pooled RSV\_IC) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant (Pooled RSV\_IC group) and healthy participants (RSV\_HA group) for the RSV-B strain at Visit 3.||2.13|1.32|
71078056|NCT01026818|141664569|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.08|STANDARD_ERROR_OF_MEAN|0.3||0.792|TWO_SIDED|95.0|-0.67|0.51||P-value is for overall satisfaction - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.51|-0.67|0.792
71078057|NCT01026818|141664569|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.24|STANDARD_ERROR_OF_MEAN|0.29||0.41|TWO_SIDED|95.0|-0.82|0.34||P-value is for overall satisfaction - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.34|-0.82|0.410
71110479|NCT03198767|141726649|SUPERIORITY||Ratio of number of events|0.37|||<|0.001|TWO_SIDED|80.0|0.28|0.49|||Mixed Models Analysis|||||0.49|0.28|<0.001
70852444|NCT01024309|141193571|SUPERIORITY_OR_OTHER|||||||0.29||||||a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum||||||0.29
70852445|NCT01024309|141193572|SUPERIORITY_OR_OTHER|||||||0.23||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test was used||||||0.23
70852446|NCT01024309|141193573|SUPERIORITY_OR_OTHER|||||||0.49||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcox Rank Sum Test||||||0.49
70852447|NCT03232333|141193624|SUPERIORITY||||||=|0.71|||||||t-test, 1 sided|||||||=0.71
70852448|NCT03232333|141193625|SUPERIORITY||||||=|0.63|||||||t-test, 1 sided|||||||=0.63
70852449|NCT03232333|141193626|SUPERIORITY||||||=|0.01|||||||t-test, 1 sided|||||||=.01
70852450|NCT00653432|141193631|SUPERIORITY|||||||0.145|||||||Ordinal GEE Model|||||||0.1450
71078058|NCT01026818|141664569|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.02|STANDARD_ERROR_OF_MEAN|0.34||0.955||95.0|-0.68|0.65||P-value is for overall satisfaction - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.65|-0.68|0.955
70852451|NCT00653432|141193632|SUPERIORITY|||||||0.5824|||||||Ordinal GEE Model|||||||0.5824
70852452|NCT00653432|141193633|SUPERIORITY|||||||0.9136|||||||Ordinal GEE Model|||||||0.9136
70852453|NCT00653432|141193634|SUPERIORITY|||||||0.1699|||||||Ordinal GEE Model|||||||0.1699
70852454|NCT00653432|141193635|SUPERIORITY|||||||0.3238|||||||Ordinal GEE Model|||||||0.3238
70852455|NCT00653432|141193636|SUPERIORITY|||||||0.0427|||||||Ordinal GEE Model|||||||0.0427
70852456|NCT00653432|141193637|SUPERIORITY|||||||0.8206|||||||Ordinal GEE Model|||||||0.8206
70852457|NCT00653432|141193638|SUPERIORITY|||||||0.9818|||||||Ordinal GEE Model|||||||0.9818
70852458|NCT00653432|141193639|SUPERIORITY|||||||0.0542|||||||Ordinal GEE Model|||||||0.0542
70852459|NCT00653432|141193640|SUPERIORITY|||||||0.323|||||||Ordinal GEE Model|||||||0.3230
70852460|NCT00567255|141193641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.56|||<|0.001||95.0|-5.19|-3.93|||ANCOVA|||||-3.93|-5.19|<0.001
70852461|NCT00567255|141193642|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.16|||<|0.001|TWO_SIDED|95.0|-5.95|-4.38|||ANCOVA|||||-4.38|-5.95|<0.001
70852462|NCT00567255|141193643|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.61|||<|0.001||95.0|4.95|8.84|||Regression, Logistic|||||8.84|4.95|<0.001
70852463|NCT00567255|141193644|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.5|||<|0.001|TWO_SIDED|95.0|4.05|7.47|||Regression, Logistic|||||7.47|4.05|<0.001
70852464|NCT00567255|141193645|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.36|||<|0.001|TWO_SIDED|95.0|3.6|7.98|||Regression, Logistic|||||7.98|3.60|<0.001
70852465|NCT00567255|141193646|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.43|||<|0.001|TWO_SIDED|95.0|-4.33|-2.53|||ANCOVA|||||-2.53|-4.33|<0.001
70852466|NCT00567255|141193647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.59|||<|0.001|TWO_SIDED|95.0|1.61|3.57|||ANCOVA|||||3.57|1.61|<0.001
70852467|NCT00567255|141193648|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.96||||0.007|TWO_SIDED||||||ANCOVA|||||||0.007
70852468|NCT00567255|141193649|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.77|||<|0.001|TWO_SIDED|95.0|2.46|5.09|||ANCOVA|||||5.09|2.46|<0.001
70852469|NCT00567255|141193650|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.24||||0.091|TWO_SIDED||||||ANCOVA|||||||0.091
70852470|NCT00567255|141193651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.64|||||TWO_SIDED|||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||
70852471|NCT00567255|141193652|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.38|||||TWO_SIDED|95.0|-1.6|0.85||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.85|-1.60|
70852472|NCT00567255|141193653|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.29|||||TWO_SIDED|||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||
71062357|NCT05921903|141632729|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.28|||||TWO_SIDED|95.0|0.97|1.7|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_IC\_2/RSV\_IC\_1) (ANCOVA model applied to the log10- transformed titers). ANCOVA model included the group as fixed effect, and SOT type and baseline log10-transformed titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 1 dose of vaccine (RSV\_IC\_1 group) and participants that received lung or kidney solid organ transplant and 2 doses of vaccine (RSV\_IC\_2 group) for the RSV-B strain at Visit 4.||1.70|0.97|
71062358|NCT05921903|141632730|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.29|||||TWO_SIDED|95.0|1.0|1.65|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/RSV\_IC\_1) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 1 dose of study intervention (RSV\_IC\_1 group) and healthy participants (RSV\_HA group) for the RSV-B strain at Visit 4.||1.65|1.00|
71062359|NCT05921903|141632731|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.01|||||TWO_SIDED|95.0|0.8|1.26|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/RSV\_IC\_2) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 2 doses of study intervention (RSV\_IC\_2 group) and healthy participants (RSV\_HA group) for the RSV-B strain at Visit 4.||1.26|0.80|
71062360|NCT00789854|141632754|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin for differences was set to 3 units in the MADRS total score.~A power set to 80% and using a Bonferroni-adjusted one-sided alpha\* = alpha/3 = 0.0083 yields a planned sample size of 192 patients per study group. With a drop out of 4% a total of 600 randomized patients were required to obtain 192 efficacy evaluable patients per treatment group."|Mean Difference (Final Values)|-2.322||||||97.5|-4.6|-0.05||The CI is for comparing add-on quetiapine versus add-on Lithium. The CI = confidence interval was adjusted for multiple comparisons. The -0.05 value should have been +3 or above to fail to reject the null hypothesis.|ANCOVA|Non-inferiority between add-on quetiapine XR and add-on lithium was shown in the Per Protocol analysis set.||Add-on quetiapine XR was tested versus add-on lithium for non-inferiority. The null hypothesis was that the add-on quetiapine treatment was non-inferior to add-on lithium.||-0.05|-4.6|
71078059|NCT01026818|141664569|SUPERIORITY_OR_OTHER||LS Mean Differences|0.05|STANDARD_ERROR_OF_MEAN|0.33||0.868|TWO_SIDED|95.0|-0.59|0.7||P-value is for overall satisfaction - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.70|-0.59|0.868
71078060|NCT01026818|141664570|SUPERIORITY_OR_OTHER||LS Mean Differences|0.33|STANDARD_ERROR_OF_MEAN|0.12||0.005|TWO_SIDED|95.0|0.1|0.56||P-value is for Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.56|0.10|0.005
71078061|NCT01026818|141664570|SUPERIORITY_OR_OTHER||LS Mean Differences|0.23|STANDARD_ERROR_OF_MEAN|0.11||0.041|TWO_SIDED|95.0|0.01|0.45||P-value is for Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.45|0.01|0.041
71110480|NCT03198767|141726649|SUPERIORITY||Ratio of number of events|0.54||||0.008|TWO_SIDED|80.0|0.41|0.72|||Mixed Models Analysis|||||0.72|0.41|0.008
71110481|NCT03198767|141726649|SUPERIORITY||Ratio of number of events|0.79||||0.141|TWO_SIDED|80.0|0.65|0.97|||Mixed Models Analysis|||||0.97|0.65|0.141
70852473|NCT00567255|141193654|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.23|||||TWO_SIDED|95.0|-9.92|-4.54||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||-4.54|-9.92|
70936993|NCT03652610|141373783|OTHER||Difference in percentage of subjects|4.54|||||TWO_SIDED|95.0|-1.97|11.01|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup W at Day 29.||11.01|-1.97|
70936994|NCT03652610|141373783|OTHER||Difference in percentage of subjects|5.25|||||TWO_SIDED|95.0|-1.11|11.57|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup Y at Day 29.||11.57|-1.11|
71078062|NCT01026818|141664570|SUPERIORITY_OR_OTHER||LS Mean Differences|0.28|STANDARD_ERROR_OF_MEAN|0.13||0.035||95.0|0.02|0.54||P-value is for Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.54|0.02|0.035
71078063|NCT01026818|141664570|SUPERIORITY_OR_OTHER||LS Mean Differences|0.13|STANDARD_ERROR_OF_MEAN|0.13||0.316|TWO_SIDED|95.0|-0.12|0.38||P-value is for Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.38|-0.12|0.316
71078064|NCT01026818|141664571|SUPERIORITY_OR_OTHER||LS Mean Differences|1.75|STANDARD_ERROR_OF_MEAN|1.02||0.086|TWO_SIDED|95.0|-0.25|3.76||P-value is for sexual relationship - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||3.76|-0.25|0.086
70852474|NCT00567255|141193655|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.36|||||TWO_SIDED|95.0|-7.29|-1.44||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||-1.44|-7.29|
70936995|NCT03652610|141373784|OTHER||Difference in percentage of subjects|-2.47|||||TWO_SIDED|95.0|-6.47|1.49|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A at Day 1||1.49|-6.47|
70852475|NCT00567255|141193656|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-0.7|1.3||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.30|-0.70|
70852476|NCT00567255|141193657|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.87|||||TWO_SIDED|95.0|0.16|1.58||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.58|0.16|
71062361|NCT00789854|141632754|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin for differences was set to 3 units in the MADRS total score.~A power set to 80% and using a Bonferroni-adjusted one-sided alpha\* = alpha/3 = 0.0083 yields a planned sample size of 192 patients per study group. With a drop out of 4% a total of 600 randomized patients were required to obtain 192 efficacy evaluable patients per treatment group."|Mean Difference (Final Values)|-1.639||||||97.5|-3.24|1.312||The CI is for comparing quetiapine XR mono versus add-on Lithium. The CI = confidence interval was adjusted for multiple comparisons. The 1.312 value should have been +3 or above to fail to reject the null hypothesis.|ANCOVA|Non-inferiority between quetiapine XR mono and add-on lithium was shown in the Per Protocol analysis set.||Quetiapine XR mono was tested versus add-on lithium for non-inferiority. The null hypothesis was that the quetiapine XR mono treatment was non-inferior to add-on lithium.||1.312|-3.24|
71062362|NCT00789854|141632755|SUPERIORITY_OR_OTHER|||||||0.0489||95.0||||Adjustment for multiplicity was done, alpha = 0.025|ANCOVA|Superiority testing of primary outcome showed no significant difference in the Modified Intention To Treat (ITT) population||The null hypothesis was that the add-on quetiapine XR treatment was not different to the add-on lithium treatment. The power calculation was done for the primary non-inferior analysis. This superiority analysis was only done if the non-inferior analysis was successful.||||0.0489
71062363|NCT00789854|141632755|SUPERIORITY_OR_OTHER|||||||0.4368||95.0||||Adjustment for multiplicity was done, alpha = 0.025|ANCOVA|Superiority testing of primary outcome showed no significant difference in the Modified Intention To Treat (ITT) population||The null hypothesis was that the quetiapine XR mono treatment was not different from the add-on lithium treatment. The power calculation was done for the primary non-inferior analysis. This superiority analysis was only done if the non-inferior analysis was successful.||||0.4368
71062364|NCT04581824|141632938|OTHER||Difference in Response Rate|9.32|||||TWO_SIDED|80.0|1.46|17.18|||||Mantel and Haenszel method with Sato's variance estimator was used for between arms comparison and was stratified by PD-L1 status and smoking status based on the strata data collected in interactive response technology (IRT) at randomization|||17.18|1.46|
71062365|NCT04796909|141632939|SUPERIORITY|||||||0.05|||||||Repeated-measures ANCOVA|||||||0.05
70936996|NCT03652610|141373784|OTHER||Difference in percentage of subjects|-0.58|||||TWO_SIDED|95.0|-6.99|5.83|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C at Day 1||5.83|-6.99|
71062366|NCT04796909|141632940|SUPERIORITY|||||||0.05|||||||Repeated-Measures ANCOVA|||||||0.05
71062367|NCT04796909|141632941|SUPERIORITY|||||||0.05|||||||Repeated-Measures ANCOVA|||||||0.05
71062368|NCT04796909|141632942|SUPERIORITY|||||||0.05|||||||Repeated-Measures ANCOVA|||||||0.05
71062369|NCT04796909|141632943|SUPERIORITY|||||||0.05|||||||Repeated-Measures ANCOVA|||||||0.05
71062370|NCT04796909|141632944|SUPERIORITY|||||||0.05|||||||Repeated-Measures ANCOVA|||||||0.05
71062371|NCT04796909|141632945|SUPERIORITY|||||||0.05|||||||Repeated-Measures ANCOVA|||||||0.05
71062372|NCT04796909|141632946|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
71062373|NCT04796909|141632947|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
71062374|NCT04796909|141632948|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
71062375|NCT04162847|141632984|SUPERIORITY||Odds Ratio (OR)|0.98||||0.76|TWO_SIDED|95.0|0.88|1.1|||Regression, Logistic|||Baseline||1.10|.88|.76
71062376|NCT04162847|141632984|SUPERIORITY||Odds Ratio (OR)|0.84||||0.001|TWO_SIDED|95.0|0.76|0.93|||Regression, Logistic|||6 week follow-up||.93|.76|.001
71062377|NCT04162847|141632984|SUPERIORITY||Odds Ratio (OR)|0.82||||0|TWO_SIDED|95.0|0.74|0.9|||Regression, Logistic|||6 month follow-up||.90|.74|.000
71062378|NCT04162847|141632984|SUPERIORITY||Odds Ratio (OR)|0.86||||0.002|TWO_SIDED|95.0|0.77|0.95|||Regression, Logistic|||2 year||.95|.77|.002
71062379|NCT04162847|141632985|SUPERIORITY||Odds Ratio (OR)|6.7||||0|TWO_SIDED|95.0|5.98|7.5|||Chi-squared|||A comparison of service uptake between the intervention and control groups over the 6-month follow-up period.||7.50|5.98|.000
70852477|NCT00567255|141193658|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|||||TWO_SIDED|95.0|-0.49|0.6||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.60|-0.49|
71062380|NCT04162847|141632985|SUPERIORITY||Odds Ratio (OR)|1.83||||0|TWO_SIDED|95.0|1.64|2.04|||Chi-squared|||A secondary analysis using the same criterion for the intervention group (access to the digital intervention during the 6-month follow-up) but expanding the control group definition to include individuals who reported having psychotherapy or starting a new medication at any point during the full 2-year follow-up period.||2.04|1.64|.000
71062381|NCT04162847|141632986|SUPERIORITY|||||||0|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||PHQ-9 6 week||||.000
71062382|NCT04162847|141632986|SUPERIORITY|||||||0|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||PHQ-9 6 months||||.000
71062383|NCT04162847|141632986|SUPERIORITY|||||||0.02|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||PHQ-9 2 year||||.02
71062384|NCT04162847|141632986|SUPERIORITY|||||||0.002|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||GADQ-IV 6 week||||.002
71062385|NCT04162847|141632986|SUPERIORITY|||||||0.8|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||GADQ-IV 6 month||||.80
71062386|NCT04162847|141632986|SUPERIORITY|||||||0.51|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||GADQ-IV 2 year||||.51
70936997|NCT03652610|141373784|OTHER||Difference in percentage of subjects|-5.95|||||TWO_SIDED|95.0|-12.33|0.47|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W at Day 1||0.47|-12.33|
70936998|NCT03652610|141373784|OTHER||Difference in percentage of subjects|-2.78|||||TWO_SIDED|95.0|-8.3|2.76|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y at Day 1||2.76|-8.30|
70936999|NCT03652610|141373784|OTHER||Difference in percentage of subjects|-3.69|||||TWO_SIDED|95.0|-8.65|1.21|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A at Day 29||1.21|-8.65|
70937000|NCT03652610|141373784|OTHER||Difference in percentage of subjects|-0.4|||||TWO_SIDED|95.0|-6.12|5.33|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C at Day 29||5.33|-6.12|
70937001|NCT03652610|141373784|OTHER||Difference in percentage of subjects|0.26|||||TWO_SIDED|95.0|-5.49|6.02|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W at Day 29||6.02|-5.49|
70937002|NCT03652610|141373784|OTHER||Difference in percentage of subjects|1.15|||||TWO_SIDED|95.0|-4.33|6.62|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y at Day 29||6.62|-4.33|
70937003|NCT03652610|141373785|OTHER||Difference in percentage of subjects|-2.91|||||TWO_SIDED|95.0|-7.24|1.37|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 1||1.37|-7.24|
70937004|NCT03652610|141373785|OTHER||Difference in percentage of subjects|-1.09|||||TWO_SIDED|95.0|-7.34|5.16|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 1||5.16|-7.34|
71062387|NCT04162847|141632986|SUPERIORITY|||||||0.004|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||SPDQ 6 week||||.004
71062388|NCT04162847|141632986|SUPERIORITY|||||||0.02|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||SPDQ 6 month||||.02
71062389|NCT04162847|141632986|SUPERIORITY|||||||0.09|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||SPDQ 2 year||||.09
70852478|NCT00567255|141193659|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.56|0.52||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.52|-0.56|
70937005|NCT03652610|141373785|OTHER||Difference in percentage of subjects|-5.95|||||TWO_SIDED|95.0|-12.35|0.5|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 1||0.50|-12.35|
70937006|NCT03652610|141373785|OTHER||Difference in percentage of subjects|-2.55|||||TWO_SIDED|95.0|-8.15|3.06|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 1||3.06|-8.15|
70937007|NCT03652610|141373785|OTHER||Difference in percentage of subjects|-3.92|||||TWO_SIDED|95.0|-8.87|0.96|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 29||0.96|-8.87|
70937008|NCT03652610|141373785|OTHER||Difference in percentage of subjects|0.07|||||TWO_SIDED|95.0|-5.52|5.65|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 29||5.65|-5.52|
70937009|NCT03652610|141373785|OTHER||Difference in percentage of subjects|-0.17|||||TWO_SIDED|95.0|-5.92|5.57|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 29||5.57|-5.92|
70937010|NCT03652610|141373785|OTHER||Difference in percentage of subjects|0.5|||||TWO_SIDED|95.0|-4.89|5.9|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 29||5.90|-4.89|
70937011|NCT01528605|141373819|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||The null hypothesis was no group difference||||<0.05
70937012|NCT01528605|141373820|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||The null hypothesis was no group difference||||<0.05
70937013|NCT01528605|141373821|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||"The null hypothesis is no group difference"||||>0.05
71062390|NCT04162847|141632986|SUPERIORITY|||||||0.66|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||PDSR 6 week||||.66
71062391|NCT04162847|141632986|SUPERIORITY|||||||0.85|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||PDSR 6 month||||.85
71062392|NCT04162847|141632986|SUPERIORITY|||||||0.97|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||PDSR 2 year||||.97
71062393|NCT04162847|141632986|SUPERIORITY|||||||0|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||EDE-Q Global 6 week||||.000
71110482|NCT03198767|141726649|SUPERIORITY||Ratio of number of events|0.9||||0.51|TWO_SIDED|80.0|0.74|1.1|||Mixed Models Analysis|||||1.10|0.74|0.510
70937014|NCT02326220|141373836|SUPERIORITY||H-L estimate of median difference|0.75|||<|0.0001|TWO_SIDED|95.0|0.667|0.833||Threshold for significance at 0.05 level.|ANCOVA||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|"Analysis was performed using the ranked analysis of covariance (ANCOVA) model with baseline frequency of the apheresis procedure (QW or Q2W) and Lp(a) levels (normal or elevated) as fixed effect and the baseline LDL-C level as a covariate. Hodges-Lehmann estimator of median difference (median of all pairwise differences; CI is Moses distribution free CI.~p-value is derived from the rank-based ANCOVA model. The model includes the baseline LDL-C value and stratification factors per IVRS."||0.833|0.667|< 0.0001
70941748|NCT04748445|141383935|OTHER||Slope|-0.0007706|STANDARD_ERROR_OF_MEAN|7.494||0.3058|TWO_SIDED|90.0|-0.002013|0.0004713|||Mixed Models Analysis|||MM\_MFCC 1st order delta 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0004713|-0.002013|0.3058
71062394|NCT04162847|141632986|SUPERIORITY|||||||0|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||EDE-Q Global 6 month||||.000
71062395|NCT04162847|141632986|SUPERIORITY|||||||0.54|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||EDE-Q Global 2 year||||.54
71062396|NCT04162847|141632987|SUPERIORITY|||||||0.48|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||Mental component summary 6 months||||.48
71062397|NCT04162847|141632987|SUPERIORITY|||||||0.04|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||Mental component summary 2 years||||.04
71062398|NCT04162847|141632987|SUPERIORITY|||||||0.97|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||Physical component summary 6 months||||.97
71062399|NCT04162847|141632987|SUPERIORITY|||||||0.8|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||Physical component summary 2 years||||.80
71062400|NCT05022667|141632999|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.3
71062401|NCT05022667|141633000|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||.5
71062402|NCT05022667|141633001|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||.2
71062403|NCT05022667|141633002|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.3
71062404|NCT05022667|141633003|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||.4
71062405|NCT05022667|141633005|SUPERIORITY|||||||0.3|||||||Chi-squared|||||||.3
70852479|NCT00567255|141193660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48|||||TWO_SIDED|95.0|-0.98|0.02||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.02|-0.98|
71062406|NCT00813150|141633009|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.196|TWO_SIDED|95.0|0.43|1.19|||Regression, Cox|||Null Hypothesis: The (median) time to progression is equal in both treatment groups||1.19|0.43|0.196
71062407|NCT00813150|141633010|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.196|TWO_SIDED|95.0|0.43|1.19|||Regression, Cox|||||1.19|0.43|0.196
71110483|NCT03198767|141726649|SUPERIORITY||Ratio of number of events|1.14||||0.401|TWO_SIDED|80.0|0.93|1.41|||Mixed Models Analysis|||||1.41|0.93|0.401
70852480|NCT02343549|141193676|SUPERIORITY||12-Month Survival Rate|0.333||||0.537|TWO_SIDED|95.0|0.075|0.701||This p-value is only based on partial enrollment of Stage 1. As enrollment was halted early, this p-value is descriptive in nature and cannot determine the success/failure of the trial.|Fisher Exact||Confidence interval estimated using the Clopper Pearson method.|Assuming the true 12-month survival rate is 0.30 under the null hypothesis, then this design will provide 90% power to detect a difference of 0.20 under the alternative hypothesis, assuming a one-sided alpha = 0.10 significance level. A Simon optimal 2-stage design with Stage 1 n=22 and a total of n=46 subjects was determined with the following rejection regions: For n = 22, the rejection region in number of subjects alive at 12 months is 0 - 7, and for n = 46 it is 8 - 17.||0.701|0.075|0.537
71062408|NCT00813150|141633011|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.645|TWO_SIDED|95.0|0.41|1.73|||Regression, Cox|||||1.73|0.41|0.645
71062409|NCT00813150|141633012|SUPERIORITY_OR_OTHER|||||||0.814|||||||Fisher Exact|||||||0.814
71062410|NCT03103087|141633029|SUPERIORITY||Treatment Difference|56.47|||<|0.0001|TWO_SIDED|95.0|46.45|66.49||P-value was stratified by baseline MBL volume (\< 225 mL or ≥ 225 mL) and geographic region (North America or Rest of World). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference is relugolix plus E2/NETA minus placebo.|||66.49|46.45|<0.0001
71110484|NCT03198767|141726650|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.426|TWO_SIDED|80.0|-0.56|0.13|||Mixed Models Analysis|||||0.13|-0.56|0.426
71110485|NCT03198767|141726650|SUPERIORITY||Median Difference (Final Values)|-1.06||||0.001|TWO_SIDED|80.0|-1.46|-0.67|||Mixed Models Analysis|||||-0.67|-1.46|0.001
71062411|NCT03103087|141633030|SUPERIORITY||Treatment Difference|47.3|||<|0.0001|TWO_SIDED|95.0|38.04|56.56||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America or Rest of World). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel|Treatment difference was relugolix plus E2/NETA minus placebo. 95% confidence interval (CI) for the difference is based on the normal approximation.||||56.56|38.04|<0.0001
71062412|NCT03103087|141633031|SUPERIORITY||Treatment Difference|-69.2|STANDARD_ERROR_OF_MEAN|7.58|<|0.0001|TWO_SIDED|95.0|-84.1|-54.3||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. Assessed at a 2-sided α = 0.05 significance.|Mixed Models Analysis||Treatment difference was relugolix plus E2/NETA minus placebo.|||-54.3|-84.1|<0.0001
71062413|NCT03103087|141633032|SUPERIORITY||Treatment Difference|55.88|||<|0.0001|TWO_SIDED|95.0|37.25|74.52||P-value is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference is relugolix plus E2/NETA minus placebo. 95% CI for difference is based on the normal approximation.|||74.52|37.25|<0.0001
71062414|NCT03103087|141633033|SUPERIORITY||Treatment Difference|29.99|||<|0.0001|TWO_SIDED|95.0|15.6|44.38||P-value is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference is relugolix plus E2/NETA minus placebo. 95% CI for difference is based on the normal approximation.|||44.38|15.6|<0.0001
71062415|NCT03103087|141633034|SUPERIORITY||Treatment Difference|-10.0|STANDARD_ERROR_OF_MEAN|8.03|=|0.2153|TWO_SIDED|95.0|-25.8|5.8||LS Means based on analysis of covariance model including treatment, randomization stratification factors, Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World), and Baseline values as covariate.|ANCOVA|||||5.8|-25.8|=0.2153
71110486|NCT03198767|141726650|SUPERIORITY||Mean Difference (Final Values)|-0.85||||0.009|TWO_SIDED|80.0|-1.25|-0.45|||Mixed Models Analysis|||||-0.45|-1.25|0.009
71110487|NCT03198767|141726650|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.135|TWO_SIDED|80.0|-0.68|-0.05|||Mixed Models Analysis|||||-0.05|-0.68|0.135
71110488|NCT03198767|141726650|SUPERIORITY||Median Difference (Final Values)|-0.19||||0.436|TWO_SIDED|80.0|-0.5|0.12|||Mixed Models Analysis|||||0.12|-0.50|0.436
71062416|NCT03103087|141633035|SUPERIORITY||Treatment Difference|-12.2|STANDARD_ERROR_OF_MEAN|4.57|=|0.0078|TWO_SIDED|95.0|-21.3|-3.2||LS Means based on analysis of covariance model including treatment, randomization stratification factors, Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World), and Baseline values as covariate.|ANCOVA|||||-3.2|-21.3|=0.0078
71062417|NCT03103087|141633036|SUPERIORITY||Treatment Difference|-33.4|STANDARD_ERROR_OF_MEAN|3.98|<|0.0001|TWO_SIDED|95.0|-41.2|-25.5||Assessed at a 2-sided α = 0.05 significance level.|Mixed Models Analysis||Relugolix plus E2/NETA minus placebo. Treatment, visit, region, Baseline MBL and treatment by visit interaction as fixed effects.|||-25.5|-41.2|<0.0001
71062418|NCT03103087|141633039|OTHER||Risk Ratio (RR)|0.16|||<|0.0001|TWO_SIDED|95.0|0.07|0.33|||Fisher Exact|||||0.33|0.07|<0.0001
71062419|NCT03103087|141633044|SUPERIORITY||||||<|0.0001||||||P-value is based on Log-rank test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World) from the proportional hazard regression model comparing relugolix plus E2/NETA with placebo.|Log Rank|||||||< 0.0001
71062420|NCT03103087|141633045|SUPERIORITY||||||<|0.0001||||||P-value for testing difference between relugolix plus E2/NETA and placebo is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||<0.0001
71062421|NCT03103087|141633046|SUPERIORITY||||||<|0.0001||||||P-value is based on Log-rank test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World) from the proportional hazard regression model comparing relugolix plus E2/NETA with placebo.|Log Rank|||||||<0.0001
71062422|NCT03103087|141633047|SUPERIORITY||||||<|0.0001||||||P-value is based on Log-rank test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World) from the proportional hazard regression model comparing relugolix plus E2/NETA with placebo.|Log Rank|||||||< 0.0001
71110489|NCT03198767|141726650|SUPERIORITY||Median Difference (Final Values)|0.18||||0.452|TWO_SIDED|80.0|-0.13|0.49|||Mixed Models Analysis|||||0.49|-0.13|0.452
71110490|NCT00570323|141726653|SUPERIORITY|||||||0.6202|||||||t-test, 2 sided|||||||0.6202
71110491|NCT04232943|141726661|OTHER|This study was designed to provide at least 96% power to detect ≥ 60% reduction in shedding rate in the IPV+ dmLT group assuming the shedding rate in the IPV alone group is at least 80%.|Risk Ratio (RR)|1.17|||||TWO_SIDED|95.0|0.56|2.464|||||RR = Ratio of proportions: (IPV+dmLT) / IPV|Analysis of Shedding of Poliovirus Type 1||2.464|0.560|
70852481|NCT02343549|141193677|OTHER|Estimation Only|Median|9.9|||||TWO_SIDED|95.0|4.8|12.8|||||The Kaplan Meier method was used to estimate median OS(in months). The Greenwood method was used to estimate confidence limits of median overall survival.|||12.8|4.8|
70852482|NCT02343549|141193678|OTHER|Estimation Only|Median|7.9|||||TWO_SIDED|95.0|4.8|10.4|||||The Kaplan Meier method was used to estimate median PFS (in months). The Greenwood method was used to estimate confidence limits of median progression free survival.|||10.4|4.8|
71062423|NCT03103087|141633048|SUPERIORITY||||||<|0.0001||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL).|Cochran-Mantel-Haenszel|||||||<0.0001
71062424|NCT03103087|141633049|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus Placebo based on mixed-effect model with treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
71062425|NCT03103087|141633050|SUPERIORITY||||||<|0.0001||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World). Lower limit of normal is Hgb \< 11.6 g/dL.|Cochran-Mantel-Haenszel|||||||<0.0001
71062426|NCT03103087|141633051|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included.|Mixed Models Analysis|||||||<0.0001
71062427|NCT03103087|141633052|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
71062428|NCT03103087|141633053|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
71062429|NCT03103087|141633054|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
71062430|NCT03103087|141633055|SUPERIORITY||||||<|0.0001||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||<0.0001
71062431|NCT03103087|141633056|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included.|Mixed Models Analysis|||||||<0.0001
71062432|NCT03103087|141633057|SUPERIORITY||||||<|0.0001||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||<0.0001
71062433|NCT03103087|141633058|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
71062434|NCT03103087|141633059|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
71062435|NCT03103087|141633061|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
71062436|NCT03103087|141633068|SUPERIORITY|||||||0.0004||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||0.0004
70852483|NCT02343549|141193679|OTHER|Estimation only|Response Rate|0.333|||||TWO_SIDED|95.0|0.075|0.701|||||Confidence interval estimated using the Clopper Pearson method.|||0.701|0.075|
70852484|NCT02343549|141193680|OTHER|Estimation only|Disease Control Rate|1.0|||||TWO_SIDED|95.0|0.664|1.0||||||||1.000|0.664|
70852485|NCT02343549|141193681|OTHER|Estimation only.|Median|8.1|||||TWO_SIDED|95.0|3.7|8.6|||||The Kaplan Meier method was used to estimate median duration of response (in months). The Greenwood method was used to estimate confidence limits of median duration of response.|||8.6|3.7|
70852486|NCT02343549|141193682|OTHER|Estimation Only|Median|7.9|||||TWO_SIDED|95.0|4.8|10.4|||||The Kaplan Meier method was used to estimate median duration of disease control (in months). The Greenwood method was used to estimate confidence limits of median duration of disease control.|||10.4|4.8|
70852487|NCT01864005|141193692|SUPERIORITY_OR_OTHER|||||||0.0021||||||not adjusted for multiple comparisons. statistical significance level: 0.05|Wilcoxon (Mann-Whitney)|||||||0.0021
70852488|NCT01864005|141193692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.421||||0.0003|TWO_SIDED|95.0|18.559|58.283|||ANOVA|||||58.283|18.559|0.0003
70852489|NCT01864005|141193693|SUPERIORITY_OR_OTHER|||||||0.0828|||||||Wilcoxon (Mann-Whitney)|||||||0.0828
70852490|NCT01864005|141193694|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
70852491|NCT01864005|141193695|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
70852492|NCT01864005|141193696|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
70852493|NCT00763698|141193697|SUPERIORITY_OR_OTHER||Objective Performance Criteria|80.0|||||ONE_SIDED|95.0|5.0||||Kaplan-Meier Survival Analysis|||The objective performance criteria established for freedom from left ventricular lead related complications at 3 months was greater than 80%. At least 80% of the patients were required to be free from left venticular lead related complications at 3 months.|||5|
70852494|NCT00763698|141193698|SUPERIORITY_OR_OTHER||Objective Performance Criteria|80.0|||||ONE_SIDED|97.5|2.5||||Wilson score interval method||||||2.5|
70852495|NCT02059291|141193700|SUPERIORITY||||||<|0.0001|||||||Fisher's exact test|||||||<0.0001
70852496|NCT02059291|141193700|SUPERIORITY|||||||0.002|||||||Fisher's exact test|||||||0.0020
70852497|NCT02059291|141193700|SUPERIORITY|||||||0.005|||||||Fisher's exact test|||||||0.0050
70852498|NCT02059291|141193701|SUPERIORITY||Odds Ratio (OR)|16.96|||<|0.0001|TWO_SIDED|95.0|4.15|69.21|||Regression, Logistic|||||69.21|4.15|<0.0001
70852499|NCT02059291|141193701|SUPERIORITY||Odds Ratio (OR)|13.63||||0.0006|TWO_SIDED|95.0|2.83|65.59|||Regression, Logistic|||||65.59|2.83|0.0006
70852500|NCT02059291|141193701|SUPERIORITY||Odds Ratio (OR)|23.79||||0.0028|TWO_SIDED|95.0|2.52|224.86|||Regression, Logistic|||||224.86|2.52|0.0028
70852501|NCT02059291|141193702|SUPERIORITY||Odds Ratio (OR)|29.78|||<|0.0001|TWO_SIDED|95.0|5.86|151.31|||Regression, Logistic|||||151.31|5.86|<0.0001
70852502|NCT02059291|141193702|SUPERIORITY||Odds Ratio (OR)|12.71||||0.001|TWO_SIDED|95.0|2.53|63.89|||Regression, Logistic|||||63.89|2.53|0.0010
70852503|NCT02059291|141193702|SUPERIORITY||Odds Ratio (OR)|6.64||||0.0149|TWO_SIDED|95.0|1.2|36.57|||Regression, Logistic|||||36.57|1.20|0.0149
70852504|NCT02059291|141193703|SUPERIORITY||Odds Ratio (OR)|17.46||||0.0286|TWO_SIDED|95.0|0.92|332.92|||Regression, Logistic|||||332.92|0.92|0.0286
70852505|NCT02059291|141193703|SUPERIORITY||Odds Ratio (OR)|5.26||||0.0778|TWO_SIDED|95.0|0.53|51.97|||Regression, Logistic|||||51.97|0.53|0.0778
70852506|NCT02059291|141193703|SUPERIORITY||Odds Ratio (OR)|16.69||||0.0235|TWO_SIDED|95.0|1.04|268.5|||Regression, Logistic|||||268.50|1.04|0.0235
71062437|NCT02549859|141633095|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
71062438|NCT02549859|141633096|SUPERIORITY||||||<|0.01|||||||Paired t-test, 2 sided|||||||<0.01
71062439|NCT02549859|141633097|SUPERIORITY||||||<|0.01|||||||Paired t-test, 2 sided|||||||<0.01
71062440|NCT02549859|141633098|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
71062441|NCT02549859|141633099|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
71062442|NCT02549859|141633100|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
71062443|NCT02549859|141633101|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
71062444|NCT02549859|141633102|SUPERIORITY||||||<|0.01|||||||Paired t-test, 2 sided|||||||<0.01
71062445|NCT02549859|141633103|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
71062446|NCT02549859|141633104|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
71062447|NCT02549859|141633105|SUPERIORITY||||||<|0.01|||||||Paired t-test, 2 sided|||||||<0.01
71062448|NCT02549859|141633106|SUPERIORITY||||||<|0.001|||||||Paired t-test, 2 sided|||||||<0.001
71062449|NCT02549859|141633107|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
71062450|NCT02549859|141633108|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
71062451|NCT02549859|141633109|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
71062452|NCT02549859|141633110|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
70852507|NCT02059291|141193704|SUPERIORITY||Odds Ratio (OR)|8.17||||0.0513|TWO_SIDED|95.0|0.75|113.44|||Regression, Logistic|||||113.44|0.75|0.0513
70852508|NCT02059291|141193704|SUPERIORITY||Odds Ratio (OR)|6.0||||0.2168|TWO_SIDED|95.0|0.27|366.24|||Regression, Logistic|||||366.24|0.27|0.2168
70852509|NCT02059291|141193704|SUPERIORITY||Odds Ratio (OR)|4.5||||0.3571|TWO_SIDED|95.0|0.15|313.49|||Regression, Logistic|||||313.49|0.15|0.3571
71062453|NCT02549859|141633111|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
71062454|NCT02549859|141633112|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
71062455|NCT02549859|141633113|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
71062456|NCT02549859|141633114|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
71062457|NCT03664232|141633116|SUPERIORITY||Least-Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.09|=|0.284|TWO_SIDED|80.0|-0.17|0.07|||Mixed effects model for repeatedmeasures|||||0.07|-0.17|=0.284
71062458|NCT03664232|141633117|SUPERIORITY||Least-Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.1|=|0.29|TWO_SIDED|80.0|-0.18|0.07|||MMRM|||||0.07|-0.18|=0.290
71062459|NCT03664232|141633118|SUPERIORITY||Least-Squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.1|=|0.231|TWO_SIDED|80.0|-0.21|0.06|||MMRM|||||0.06|-0.21|=0.231
71062460|NCT02342678|141633241|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.13|TWO_SIDED|95.0|-0.3|2.2|||ANCOVA|||||2.2|-0.3|0.13
71062461|NCT02342678|141633242|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.18|TWO_SIDED|95.0|-0.2|1.1|||ANCOVA|||||1.1|-0.2|0.18
71062462|NCT02342678|141633243|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.89|TWO_SIDED|95.0|-1.2|1.3|||ANCOVA|||||1.3|-1.2|0.89
71062463|NCT02342678|141633244|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.13|TWO_SIDED|95.0|-0.3|2.0|||ANCOVA|||||2.0|-0.3|0.13
71062464|NCT02342678|141633245|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.73|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||||0.4|-0.3|0.73
71062465|NCT02342678|141633246|SUPERIORITY||Mean Difference (Final Values)|-19.3||||0.38|TWO_SIDED|95.0|-62.9|24.3|||ANCOVA|||||24.3|-62.9|0.38
71062466|NCT02342678|141633247|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.24|TWO_SIDED|95.0|-3.7|14.8|||ANCOVA|||||14.8|-3.7|0.24
71062467|NCT02342678|141633248|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.46|TWO_SIDED|95.0|-0.4|0.9|||ANCOVA|||||0.9|-0.4|0.46
71062468|NCT00460603|141633274|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.585||||0.9726|TWO_SIDED|95.0|0.332|1.031|||Cochran-Mantel-Haenszel|||One-sided Cochran-Mantel-Haenszel test of treatment stratified by prior adjuvant chemotherapy (yes versus \[vs.\] no) and prior pelvic irradiation (yes vs. no) was used for the analysis.||1.031|0.332|0.9726
71062469|NCT00460603|141633274|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.735||||0.8391|TWO_SIDED|95.0|0.399|1.352|||Cochran-Mantel-Haenszel|||One-sided Cochran-Mantel-Haenszel test of treatment stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no) was used for the analysis.||1.352|0.399|0.8391
71062470|NCT00460603|141633274|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.797||||0.8192|TWO_SIDED|95.0|0.489|1.299|||Cochran-Mantel-Haenszel|||One-sided Cochran-Mantel-Haenszel test of treatment stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no) was used for the analysis.||1.299|0.489|0.8192
71062471|NCT00460603|141633306|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.5699|TWO_SIDED|95.0|0.47|2.45|||Log Rank|||Hazard ratio and corresponding 95% confidence interval (CI) was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||2.45|0.47|0.5699
71062472|NCT00460603|141633306|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.2167|TWO_SIDED|95.0|0.33|1.61|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||1.61|0.33|0.2167
71110492|NCT04232943|141726661|OTHER|This study was designed to provide at least 96% power to detect ≥ 60% reduction in shedding rate in the IPV+ dmLT group assuming the shedding rate in the IPV alone group is at least 80%.|Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.606|1.51|||||RR = Ratio of proportions: (IPV+dmLT) / IPV|Analysis of Shedding of Poliovirus Type 3||1.510|0.606|
71110493|NCT03896477|141726681|OTHER||GMC Ratio|2.91|||||TWO_SIDED|95.0|2.47|3.44||||||Serotype 1 geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||3.44|2.47|
71110494|NCT03896477|141726681|OTHER||GMC Ratio|1.44|||||TWO_SIDED|95.0|1.23|1.69||||||Serotype 1 geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.69|1.23|
71110495|NCT03896477|141726681|OTHER||GMC Ratio|1.93|||||TWO_SIDED|95.0|1.66|2.25||||||Serotype 5 geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||2.25|1.66|
71062473|NCT00460603|141633306|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49||||0.8746|TWO_SIDED|95.0|0.75|2.98|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||2.98|0.75|0.8746
71062474|NCT00460603|141633307|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.8884|TWO_SIDED|95.0|0.81|2.41|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||2.41|0.81|0.8884
71062475|NCT00460603|141633307|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12||||0.6648|TWO_SIDED|95.0|0.66|1.89|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||1.89|0.66|0.6648
71062476|NCT00460603|141633307|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.8065|TWO_SIDED|95.0|0.75|2.07|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||2.07|0.75|0.8065
71062477|NCT00460603|141633308|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.155||||0.6904|TWO_SIDED|95.0|0.656|2.033|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||2.033|0.656|0.6904
71062478|NCT00460603|141633308|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.203||||0.7364|TWO_SIDED|95.0|0.676|2.141|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||2.141|0.676|0.7364
71110496|NCT03896477|141726681|OTHER||GMC Ratio|0.76|||||TWO_SIDED|95.0|0.65|0.88||||||Serotype 5 geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||0.88|0.65|
71110497|NCT03896477|141726681|OTHER||GMC Ratio|16.03|||||TWO_SIDED|95.0|12.84|20.03||||||Serotype 6A geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||20.03|12.84|
71110498|NCT03896477|141726681|OTHER||GMC Ratio|0.87|||||TWO_SIDED|95.0|0.72|1.06||||||Serotype 6A geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.06|0.72|
71110499|NCT03896477|141726681|OTHER||GMC Ratio|2.51|||||TWO_SIDED|95.0|2.14|2.95||||||Serotype 6B geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||2.95|2.14|
71110500|NCT03896477|141726681|OTHER||GMC Ratio|0.8|||||TWO_SIDED|95.0|0.68|0.95||||||Serotype 6B geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||0.95|0.68|
71110501|NCT03896477|141726681|OTHER||GMC Ratio|2.11|||||TWO_SIDED|95.0|1.83|2.44||||||Serotype 7F geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||2.44|1.83|
71110502|NCT03896477|141726681|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.91|1.22||||||Serotype 7F geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.22|0.91|
71110503|NCT03896477|141726681|OTHER||GMC Ratio|1.41|||||TWO_SIDED|95.0|1.21|1.65||||||Serotype 9V geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.65|1.21|
71110504|NCT03896477|141726681|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.76|1.05||||||Serotype 9V geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.05|0.76|
71110505|NCT03896477|141726681|OTHER||GMC Ratio|1.65|||||TWO_SIDED|95.0|1.29|2.1||||||Serotype 14 geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||2.10|1.29|
71110506|NCT03896477|141726681|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.73|1.12||||||Serotype 14 geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.12|0.73|
70941749|NCT04748445|141383935|OTHER||Slope|0.0002388|STANDARD_ERROR_OF_MEAN|6.494||0.7137|TWO_SIDED|90.0|-0.0008374|0.001315|||Mixed Models Analysis|||MM\_MFCC 1st order delta 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001315|-0.0008374|0.7137
71062479|NCT00460603|141633308|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.941||||0.414|TWO_SIDED|95.0|0.535|1.653|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||1.653|0.535|0.4140
71062480|NCT00289848|141633320|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.03|STANDARD_DEVIATION|1.08|<|0.001||95.0|-1.23|-0.83|||ANCOVA|ANCOVA with terms of treatment, country, prior diabetes pharmacotherapy (not on AHA or on AHA), and baseline A1C as a covariate||||-0.83|-1.23|<0.001
71062481|NCT00289848|141633321|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-31.0|STANDARD_DEVIATION|39.8|<|0.001||95.0|-38.4|-23.7|||ANCOVA|ANCOVA with terms of treatment, country, prior diabetes pharmacotherapy (not on AHA or on AHA), and baseline FPG as a covariate||||-23.7|-38.4|<0.001
71110507|NCT03896477|141726681|OTHER||GMC Ratio|3.69|||||TWO_SIDED|95.0|2.91|4.67||||||Serotype 19A geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||4.67|2.91|
71110508|NCT03896477|141726681|OTHER||GMC Ratio|0.72|||||TWO_SIDED|95.0|0.6|0.87||||||Serotype 19A geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||0.87|0.60|
71110509|NCT03896477|141726681|OTHER||GMC Ratio|0.64|||||TWO_SIDED|95.0|0.52|0.79||||||Serotype 19F geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||0.79|0.52|
71110510|NCT03896477|141726681|OTHER||GMC Ratio|0.74|||||TWO_SIDED|95.0|0.62|0.89||||||Serotype 19F geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||0.89|0.62|
71110511|NCT03896477|141726681|OTHER||GMC Ratio|2.29|||||TWO_SIDED|95.0|1.89|2.76||||||Serotype 23F geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||2.76|1.89|
71110512|NCT03896477|141726681|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.82|1.22||||||Serotype 23F geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.22|0.82|
71110513|NCT01000506|141726719|SUPERIORITY_OR_OTHER||Rate Ratio|0.52|||<|0.001|TWO_SIDED|95.0|0.39|0.69||Hochberg testing procedure with a one-sided alpha of 2.5% used for controlling multiplicity|Negative Binomial regression model||Number of exacerbations per year in the mepolizumab 75mg IV arm divided by the number of exacerbations per year in the placebo arm.|||0.69|0.39|<0.001
71110514|NCT01000506|141726719|SUPERIORITY_OR_OTHER||Rate Ratio|0.61|||<|0.001|TWO_SIDED|95.0|0.46|0.81||Hochberg testing procedure with a one-sided alpha of 2.5% used for controlling multiplicity|Negative Binomial regression model||Number of exacerbations per year in the mepolizumab 250 mg IV arm divided by the number of exacerbations per year in the placebo arm.|||0.81|0.46|<0.001
71062482|NCT00289848|141633322|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-56.6|STANDARD_DEVIATION|59.2|<|0.001||95.0|-68.8|-44.3|||ANCOVA|ANCOVA with terms of treatment, country, prior diabetes pharmacotherapy (not on AHA or on AHA), and baseline 2-hr PMG as a covariate||||-44.3|-68.8|<0.001
71062483|NCT00860795|141633326|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|95.0|||||Regression, Linear|||||||.17
71062484|NCT00860795|141633327|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|95.0|||||Regression, Linear|||||||.72
71062485|NCT00860795|141633328|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED|95.0|||||Regression, Linear|||||||.2
71062486|NCT00860795|141633330|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED|95.0|||||Regression, Linear|||||||.51
71062487|NCT00860795|141633331|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|95.0|||||Regression, Linear|||||||.43
71062488|NCT00860795|141633332|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED|95.0|||||Regression, Linear|||||||.61
71062489|NCT03871543|141633333|OTHER|Statistical Difference|Mean difference|0.159|STANDARD_ERROR_OF_MEAN|0.287|||ONE_SIDED|95.0|-0.402||||Mixed Models Analysis|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Symptomatic minus Asymptomatic|Upper Lid|||-0.402|
71062490|NCT03871543|141633333|OTHER|Statistical Difference|Mean Difference|0.236|STANDARD_ERROR_OF_MEAN|0.289|||ONE_SIDED|95.0|-0.328||||Mixed Models Analysis|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Symptomatic minus Asymptomatic|Lower Lid|||-0.328|
70937015|NCT02326220|141373837|SUPERIORITY||Least Square (LS) Mean Difference|-55.3|STANDARD_ERROR_OF_MEAN|3.9|<|0.0001|TWO_SIDED|95.0|-63.0|-47.5||Threshold for significance at 0.05 level.|MMRM|MMRM: Mixed-effect model with repeated measures|Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-47.5|-63.0|< 0.0001
70937016|NCT02326220|141373838|SUPERIORITY||H-L estimate of median difference|0.5|||<|0.0001|TWO_SIDED|95.0|0.5|1.0||Threshold for significance at 0.05 level.|ANCOVA||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||1.000|0.500|<.0001
71062491|NCT03871543|141633334|OTHER|Statistical difference|Mean Ratio|0.918|||||ONE_SIDED|95.0||1.227|||Generalized Linear Mixed Model|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean ratio was calculated as Symptomatic divided by Asymptomatic|||1.227||
71062492|NCT03871543|141633335|OTHER|Statistical difference|Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.019|||ONE_SIDED|95.0||0.022|||Mixed Models Analysis|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Symptomatic minus Asymptomatic|||0.022||
71062493|NCT03871543|141633336|OTHER|Statistical difference|Mean Difference|1.185|STANDARD_ERROR_OF_MEAN|3.483|||ONE_SIDED|95.0|-4.613||||Mixed Models Analysis|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Symptomatic minus Asymptomatic||||-4.613|
71062494|NCT03871543|141633337|OTHER|Statistical difference|Mean Ratio|1.984|||||ONE_SIDED|95.0|1.198||||Generalized Linear Mixed Model|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean Ratio was calculated as Symptomatic divided by Asymptomatic|Upper Lid|||1.198|
71062495|NCT03871543|141633337|OTHER|Statistical Difference|Mean Ratio|1.8|||||ONE_SIDED|95.0|1.093||||Generalized Linear Mixed Model|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean Ratio was calculated as Symptomatic divided by Asymptomatic|Lower Lid|||1.093|
71062496|NCT03871543|141633338|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.1416||||0.3446|TWO_SIDED|95.0|-0.4148|0.1551|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.1551|-0.4148|0.3446
71062497|NCT03871543|141633339|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|0.0887||||0.5556|TWO_SIDED|95.0|-0.207|0.3694|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.3694|-0.2070|0.5556
71062498|NCT03871543|141633340|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.2052||||0.1676|TWO_SIDED|95.0|-0.4676|0.0905|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.0905|-0.4676|0.1676
71062499|NCT03871543|141633341|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|0.0903||||0.5483|TWO_SIDED|95.0|-0.2054|0.3709|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.3709|-0.2054|0.5483
71062500|NCT03871543|141633342|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.2679||||0.0719|TWO_SIDED|95.0|-0.5205|0.0278|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.0278|-0.5205|0.0719
71062501|NCT03871543|141633343|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.3434||||0.019|TWO_SIDED|95.0|-0.5786|0.0554|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.0554|-0.5786|0.0190
71062502|NCT03871543|141633344|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.2975||||0.042|TWO_SIDED|95.0|-0.541|-0.0078|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||-0.0078|-0.5410|0.0420
71062503|NCT03871543|141633345|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|0.127||||0.3973|TWO_SIDED|95.0|-0.1696|0.4024|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.4024|-0.1696|0.3973
71062504|NCT03871543|141633346|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.021||||0.8894|TWO_SIDED|95.0|-0.3094|0.271|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.2710|-0.3094|0.8894
71110515|NCT01000506|141726719|SUPERIORITY_OR_OTHER||Rate Ratio|0.48|||<|0.001|TWO_SIDED|95.0|0.36|0.64||Hochberg testing procedure with a one-sided alpha of 2.5% used for controlling multiplicity|Negative Binomial regression model||Number of exacerbations per year in the mepolizumab 750 mg IV arm divided by the number of exacerbations per year in the placebo arm.|||0.64|0.36|<0.001
71110516|NCT02185534|141726762|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25|Geometric mean ratio|104.43|||||TWO_SIDED|90.0|92.27|118.19|||||Geometric mean ratio is calculated as A/B, where A= European clopidogrel and B=Japanese clopidogrel|||118.19|92.27|
71062505|NCT03871543|141633347|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|0.0762||||0.6129|TWO_SIDED|95.0|-0.219|0.3585|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.3585|-0.2190|0.6129
71062506|NCT03871543|141633348|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.1402||||0.3493|TWO_SIDED|95.0|-0.4137|0.1565|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.1565|-0.4137|0.3493
70937017|NCT02326220|141373839|SUPERIORITY||LS Mean Difference|-44.0|||<|0.0001|TWO_SIDED|95.0|-51.3|-36.6||Threshold for significance at 0.05 level.|MMRM||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-36.6|-51.3|< 0.0001
70937018|NCT02326220|141373840|SUPERIORITY||LS Mean Difference|-50.0|||<|0.0001|TWO_SIDED|95.0|-57.3|-42.7||Threshold for significance at 0.05 level.|MMRM||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-42.7|-57.3|< 0.0001
70937019|NCT02326220|141373841|SUPERIORITY||LS Mean Difference|-39.4|||<|0.0001|TWO_SIDED|95.0|-45.6|-33.2||Threshold for significance at 0.05 level.|MMRM||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-33.2|-45.6|< 0.0001
70937020|NCT02326220|141373842|SUPERIORITY||LS Mean Difference|4.2||||0.3012|TWO_SIDED|95.0|-3.9|12.3||Threshold for significance at 0.05 level.|MMRM||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||12.3|-3.9|0.3012
70937021|NCT02699099|141373859|NON_INFERIORITY|Non-inferiority (1 month post-Dose 3 of SB257049) was defined as the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio (RTS,S group/Coad group) for anti-CS, being below a limit of 2.|Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.81|1.07|||ANOVA|||Adjusted GMC ratios for anti-CS antibody: To demonstrate the non-inferiority of the antibody response to the CS antigen when SB257049 is co-administered with YF vaccine and a combined measles and rubella vaccine versus SB257049 administered alone.||1.07|0.81|
70937022|NCT02699099|141373864|NON_INFERIORITY|Non-inferiority was defined as the upper limit of the 95% confidence interval (CI) for the difference in seroconversion rate of the anti-measles antibody, being below 10% for the two groups (Control Group minus Coad Group).|Difference in percentage|2.05|||||TWO_SIDED|95.0|-1.29|5.89|||Miettinen and Nurminen method|Miettinen and Nurminen method was used to construct 95%CI for difference between groups||Difference in seroconversion rates against measles antibodies: To demonstrate the non-inferiority of the antibody response to the measles vaccine antigen when YF vaccine and a combined measles and rubella vaccine are coadministered with SB257049 versus administration without SB257049.||5.89|-1.29|
70937023|NCT02699099|141373867|NON_INFERIORITY|Non-inferiority was defined as the upper limit of the 95% confidence interval (CI) for the difference in seroconversion rates of the anti-rubella antibody, being below 10% for the two groups (Control Group minus Coad Group).|Difference in percentage|0.5|||||TWO_SIDED|95.0|-1.29|2.78|||Miettinen and Nurminen method|Miettinen and Nurminen method was used to construct 95%CI for difference between groups||"Difference in seroconversion rates against Rubella antibodies: To demonstrate the non-inferiority of the antibody response to the rubella vaccine antigen when YF vaccine and a combined measles and rubella vaccine are coadministered.~with SB257049 versus administration without SB257049."||2.78|-1.29|
70937024|NCT02699099|141373870|NON_INFERIORITY|Non-inferiority was defined as the upper limit of the 95% confidence interval (CI) for the difference in seropositivity rates of the anti-yellow fever antibody , being below 10% for the two groups (Control Group minus Coad Group).|Difference in percentage|0.55|||||TWO_SIDED|95.0|-2.3|3.65|||Miettinen and Nurminen method|Miettinen and Nurminen method was used to construct 95%CI for difference between groups||Difference in seropositivity rates against Yellow Fever antibodies: To demonstrate the non-inferiority of the antibody response to the YF vaccine antigen when YF vaccine and a combined measles and rubella vaccine are coadministered with SB257049 versus administration without SB257049.||3.65|-2.30|
70937025|NCT02699099|141373896|NON_INFERIORITY|Non-inferiority (1 month post-Dose 3 of SB257049) was defined as the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio (RTS,S group/Coad group) for anti-CS, being below a limit of 2.|Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.81|1.07|||ANOVA|||Adjusted GMC ratios for anti-CS antibody: To demonstrate the non-inferiority of the antibody response to the CS antigen when SB257049 is co-administered with YF vaccine and a combined measles and rubella vaccine versus SB257049 administered alone.||1.07|0.81|
70937026|NCT03659136|141373916|OTHER||Hazard Ratio (HR)|1.19||||0.6534|TWO_SIDED|95.0|0.55|2.59|||Log-rank test|Two-sided log-rank test stratified for presence of baseline bone-only metastases, prior (CDK) 4/6 inhibitor treatment and menopause status.|Comparison vs. Placebo+Everolimus+Exemestane.|Cox proportional hazards model stratified for presence of baseline bone-only metastases, prior cyclin-dependent kinase (CDK) 4/6 inhibitor treatment and menopause status.||2.59|0.55|0.6534
70937027|NCT03659136|141373917|OTHER||Hazard Ratio (HR)|0.5||||0.1797|TWO_SIDED|95.0|0.18|1.4|||Log rank test|Two-sided log-rank test stratified for presence of baseline bone-only metastases, prior CDK 4/6 inhibitor treatment and menopause status.|Comparison vs. Placebo+Everolimus+Exemestane.|Cox proportional hazards model stratified for presence of baseline bone-only metastases, prior cyclin-dependent kinase (CDK) 4/6 inhibitor treatment and menopause status.||1.40|0.18|0.1797
71062507|NCT03871543|141633349|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.1192||||0.427|TWO_SIDED|95.0|-0.3958|0.1772|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.1772|-0.3958|0.4270
71062508|NCT01169064|141633359|SUPERIORITY_OR_OTHER|||||||0.365|||||||Chi-squared|||||||.365
71062509|NCT01169064|141633360|SUPERIORITY|||||||0.282|||||||Mixed Models Analysis|||||||.282
71062510|NCT01416636|141633368|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
71062511|NCT01416636|141633368|SUPERIORITY|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||||||0.0003
71062512|NCT01416636|141633369|SUPERIORITY|||||||0.605|||||||Wilcoxon (Mann-Whitney)|||||||0.605
71062513|NCT01416636|141633370|SUPERIORITY|||||||0.307|||||||Wilcoxon (Mann-Whitney)|||||||0.307
71062514|NCT01416636|141633371|SUPERIORITY|||||||0.0019|||||||Chi-squared|||||||0.0019
71062515|NCT01416636|141633372|SUPERIORITY|||||||0.557|||||||Wilcoxon (Mann-Whitney)|||||||0.557
71062516|NCT01416636|141633373|SUPERIORITY|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
71062517|NCT01416636|141633374|SUPERIORITY|||||||1e-05|||||||Wilcoxon (Mann-Whitney)|||||||0.00001
71062518|NCT01416636|141633375|SUPERIORITY|||||||3e-06|||||||Wilcoxon (Mann-Whitney)|||||||0.000003
71062519|NCT01416636|141633376|SUPERIORITY|||||||8e-05|||||||Wilcoxon (Mann-Whitney)|||||||0.00008
71062520|NCT01416636|141633377|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
71062521|NCT01416636|141633378|SUPERIORITY|||||||0.227|||||||Wilcoxon (Mann-Whitney)|||||||0.227
71062522|NCT02301169|141633380|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: no difference in mean change from baseline to day 42 of pain severity as measured by weekly means of the daily Average Pain Score (APS), T4P1001 compared with placebo|Mean Difference (Final Values)|0.3748299||||0.4162|TWO_SIDED|95.0|-0.5479411|1.297601||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons|t-test, 2 sided|Welch two sample t-test||||1.2976010|-0.5479411|0.4162
71062523|NCT02301169|141633381|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: no difference in mean change from baseline to day 42 of pain severity as measured by weekly means of the daily Worst Pain Score (WPS), T4P1001 compared with placebo.|Mean Difference (Final Values)|0.1255102||||0.7887|TWO_SIDED|95.0|-0.8152493|1.0662697||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons.|t-test, 2 sided|Welch two sample t-test||||1.0662697|-0.8152493|0.7887
71062524|NCT02301169|141633382|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: no difference in mean change from baseline to day 42 of pain severity as measured by Investigator Global Assessment of Change, T4P1001 compared with Placebo|Mean Difference (Final Values)|0.802381||||0.2353|TWO_SIDED|95.0|-0.5457743|2.1505362||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons.|t-test, 2 sided|Welch two sample t-test||||2.1505362|-0.5457743|0.2353
71062525|NCT02301169|141633383|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: no difference in mean change from baseline to day 42 of pain intensity measured after heat pain stimuli, T4P1001 compared with placebo.|Mean Difference (Final Values)|0.7656429||||0.06204|TWO_SIDED|95.0|-0.0406744|1.5719601||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons.|t-test, 2 sided|Welch two sample t-test||||1.5719601|-0.0406744|0.06204
71062526|NCT02301169|141633384|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: no difference in mean change from baseline to day 42 of pain severity as measured by the Brief Pain Inventory (BPI), T4P1001 compared with placebo.|Mean Difference (Final Values)|1.683333||||0.3386|TWO_SIDED|95.0|-1.83119|5.197857||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons.|t-test, 2 sided|Welch two sample t-test||||5.197857|-1.831190|0.3386
71062527|NCT02949973|141633391|OTHER||Percentage|70.0|||||TWO_SIDED|||||||||||||
71062528|NCT02949973|141633392|OTHER||Percentage|40.0|||||TWO_SIDED|||||||||||||
70937028|NCT03659136|141373918|OTHER||Odds Ratio (OR)|1.31||||0.4932|TWO_SIDED|95.0|0.6|2.86|||Regression, Logistic|Logistic regression model adjusted for presence of baseline bone-only metastases, prior CDK 4/6 inhibitor treatment and menopause status.|Comparison vs. Placebo+everolimus+exemestane. An odds ratio \>1 indicates a benefit to the xentuzumab arm.|||2.86|0.60|0.4932
71062529|NCT02949973|141633393|OTHER||Percentage|20.0|||||TWO_SIDED|||||||||||||
71062530|NCT02949973|141633394|OTHER||Percentage|20.0|||||TWO_SIDED|||||||||||||
71062531|NCT02949973|141633395|OTHER||Percentage|70.0|||||TWO_SIDED|95.0|34.8|93.3||||||||93.3|34.8|
71062532|NCT02949973|141633396|OTHER||Percentage|50.0|||||TWO_SIDED|95.0|15.7|84.3||||||||84.3|15.7|
71062533|NCT01422213|141633397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.363|STANDARD_ERROR_OF_MEAN|0.072|<|0.0001|TWO_SIDED|95.0|0.22|0.5||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the composite z-score was analysed using the mixed model for repeated measurements (MMRM) with an unstructured covariance structure. The model included terms for grouped site, baseline composite z-score, baseline composite z-score-by-visit interaction, and treatment-by-visit interaction.||0.50|0.22|<0.0001
71062534|NCT01422213|141633397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.071|<|0.0001|TWO_SIDED|95.0|0.19|0.47||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the composite z-score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline composite z-score, baseline composite z-score-by-visit interaction, and treatment-by-visit interaction.||0.47|0.19|<0.0001
71062535|NCT01422213|141633398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2|STANDARD_ERROR_OF_MEAN|0.87|<|0.0001|TWO_SIDED|95.0|2.5|5.9||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the DSST (number of correct symbols) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||5.90|2.50|<0.0001
71062536|NCT01422213|141633398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.26|STANDARD_ERROR_OF_MEAN|0.86|<|0.0001|TWO_SIDED|95.0|2.57|5.94||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the DSST (number of correct symbols) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||5.94|2.57|<0.0001
71062537|NCT01422213|141633399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02|STANDARD_ERROR_OF_MEAN|0.46||0.0287|TWO_SIDED|95.0|0.11|1.93||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the RAVLT (acquisition) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||1.93|0.11|0.0287
71062538|NCT01422213|141633399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.46||0.1988|TWO_SIDED|95.0|-0.31|1.5||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the RAVLT (acquisition) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||1.50|-0.31|0.1988
71062539|NCT01422213|141633400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|0.24||0.0033|TWO_SIDED|95.0|0.24|1.19||Since the p-value for RAVLT acquisition for 10 mg was \>0.025, the p-value for this test is nominal.|Mixed Models Analysis|||Based on the FAS, the RAVLT (delayed recall) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||1.19|0.24|0.0033
71062540|NCT01422213|141633400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.24||0.0073|TWO_SIDED|95.0|0.17|1.12||Since the p-value for RAVLT acquisition for 20 mg was \>0.025, the p-value for this test is nominal.|Mixed Models Analysis|||Based on the FAS, the RAVLT (delayed recall) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||1.12|0.17|0.0073
71062541|NCT01422213|141633401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.76|STANDARD_ERROR_OF_MEAN|1.37||0.0061|TWO_SIDED|95.0|-6.45|-1.08||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the TMT A (Speed of Processing) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-1.08|-6.45|0.0061
71062542|NCT01422213|141633401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|1.35||0.0052|TWO_SIDED|95.0|-6.46|-1.14||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the TMT A (Speed of Processing) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-1.14|-6.46|0.0052
71062543|NCT01422213|141633402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.57|STANDARD_ERROR_OF_MEAN|2.73||0.0058|TWO_SIDED|95.0|-12.93|-2.2||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the TMT B (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-2.20|-12.93|0.0058
71110517|NCT02185534|141726762|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio is calculated as A/C, where A= European clopidogrel and C=US clopidogrel|Geometric mean ratio|97.19|||||TWO_SIDED|90.0|81.12|116.45|||||Geometric mean ratio is calculated as A/C, where A= European clopidogrel and C=US clopidogrel|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25||116.45|81.12|
71110518|NCT02185534|141726763|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25.|Geometric mean ratio|108.06|||||TWO_SIDED|90.0|95.46|122.33|||||Geometric mean ratio is calculated as A/B, where A= European clopidogrel and B=Japanese clopidogrel|||122.33|95.46|
71062544|NCT01422213|141633402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.01|STANDARD_ERROR_OF_MEAN|2.7||0.0009|TWO_SIDED|95.0|-14.32|-3.7||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the TMT B (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-3.70|-14.32|0.0009
71062545|NCT01422213|141633403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|1.28||0.0018|TWO_SIDED|95.0|-6.5|-1.49||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the Congruent STROOP Time to Complete (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-1.49|-6.50|0.0018
71062546|NCT01422213|141633403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.45|STANDARD_ERROR_OF_MEAN|1.26||0.0005|TWO_SIDED|95.0|-6.93|-1.97||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the Congruent STROOP Time to Complete (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-1.97|-6.93|0.0005
71110519|NCT02185534|141726763|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25.|Geometric mean ratio|105.79|||||TWO_SIDED|90.0|95.22|117.53|||||Geometric mean ratio is calculated as A/C, where A= European clopidogrel and C=US clopidogrel|||117.53|95.22|
71110520|NCT02185534|141726764|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25.|Geometric mean ratio|93.94|||||TWO_SIDED|90.0|87.12|101.29|||||Geometric mean ratio is calculated as A/B, where A= European clopidogrel and B=Japanese clopidogrel|||101.29|87.12|
71110521|NCT02185534|141726764|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25|Geometric mean ratio|92.03|||||TWO_SIDED|90.0|84.91|99.75|||||Geometric mean ratio is calculated as A/C, where A= European clopidogrel and C=US clopidogrel|||99.75|84.91|
71110522|NCT02041299|141726765|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 96.01% confidence interval (CI) is less than or equal to 2 mg/g dw.|Mean Difference (Net)|0.26||||0.0399|TWO_SIDED|96.01|-0.97|1.48|||ANCOVA|||||1.48|-0.97|0.0399
71110523|NCT02041299|141726766|NON_INFERIORITY|Support for non-inferiority is demonstrated if the 96.01% CI contains zero (0)|Mean Difference (Net)|-0.000295||||0.0399|TWO_SIDED|96.01|-0.054247|0.053657|||ANCOVA|||Data for this measure were log-transformed.||0.053657|-0.054247|0.0399
71110524|NCT02041299|141726767|NON_INFERIORITY|Support for non-inferiority of deferiprone to deferoxamine in serum ferritin is demonstrated if the 96.01% CI contains zero (0)|Mean Difference (Net)|375.07||||0.0399|TWO_SIDED|96.01|-260.63|1010.76|||ANCOVA|||||1010.76|-260.63|0.0399
71110525|NCT02041299|141726768|SUPERIORITY|Comparison of treatment groups on change in score on SF-36 Physical Summary||||||0.9214|||||||ANCOVA|||||||0.9214
70937029|NCT03659136|141373920|OTHER||Odds Ratio (OR)|1.2||||0.7759|TWO_SIDED|95.0|0.34|4.43|||Regression, Logistic|Logistic regression model adjusted for presence of baseline bone-only metastases, prior CDK 4/6 inhibitor treatment and menopause status.|Comparison vs. Placebo+everolimus+exemestane. An odds ratio \>1 indicates a benefit to the xentuzumab arm.|||4.43|0.34|0.7759
71110526|NCT02041299|141726768|SUPERIORITY|||||||0.1174|||||||ANCOVA|||Comparison of treatment groups on change in score on SF-36 Mental Summary||||0.1174
71110527|NCT02041299|141726768|SUPERIORITY|||||||0.6488|||||||ANCOVA|||Comparison of treatment groups on change in score on CHQ-PF50 Physical Summary||||0.6488
71110528|NCT02041299|141726768|SUPERIORITY|||||||0.5915|||||||ANCOVA|||Comparison of treatment groups on change in score on CHQ-PF50 Psychosocial Summary||||0.5915
71110529|NCT02389465|141726769|OTHER|||||||0.44|||||||t-test, 2 sided|||IL6 levels in healthy controls pre- and post-treatment compared using a paired t-test||||.44
71110530|NCT02389465|141726769|OTHER|||||||0.11|||||||t-test, 2 sided|||IL6 levels in the placebo group pre- and post-treatment compared using a paired t-test||||.11
71110531|NCT02389465|141726769|OTHER|||||||0.42|||||||t-test, 2 sided|||IL6 levels in the escitalopram group pre- and post-treatment compared using a paired t-test||||.42
71110532|NCT02389465|141726769|OTHER|||||||0.49|||||||t-test, 2 sided|||IL-6 levels in the escitalopram + celecoxib group pre- and post-treatment compared using a paired t-tes||||.49
71110533|NCT02389465|141726769|OTHER|||||||0.23|||||||t-test, 2 sided|||IL6 levels at completion of study compared between all MDD groups (placebo, escitalopram, and escitalopram + celecoxib) and the healthy control group||||.23
71110534|NCT02389465|141726770|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||MADRS scores at the final visit compared between the healthy control and escitalopram + celecoxib groups||||.003
71110535|NCT02389465|141726770|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||MADRS scores at the final visit compared between the healthy control and escitalopram groups||||<.001
71110536|NCT02389465|141726770|SUPERIORITY|||||||0.034|||||||Wilcoxon (Mann-Whitney)|||MADRS scores at the final visit compared between the healthy control and placebo groups||||.034
71110537|NCT02389465|141726770|SUPERIORITY|||||||0.03|||||||ANCOVA|||MADRS scores at the final visit compared between the placebo groups and all groups receiving escitalopram (both with and without celecoxib)||||.03
71110538|NCT02389465|141726771|OTHER|||||||0.29|||||||t-test, 2 sided|||IL10 levels in healthy controls pre- and post-treatment compared using a paired t-test||||.29
70937030|NCT03659136|141373921|OTHER||Cox Proportional Hazard|0.97||||0.9279|TWO_SIDED|95.0|0.54|1.76|||Log Rank|Two-sided log-rank test stratified for presence of baseline bone-only metastases, prior CDK4/6 inhibitor treatment and menopause status.|Comparison versus Placebo+everolimus+exemestane.|Cox proportional hazards model stratified for presence of baseline bone-only metastases, prior cyclin-dependent kinase (CDK) 4/6 inhibitor treatment and menopause status.||1.76|0.54|0.9279
71062547|NCT01422213|141633404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.75|STANDARD_ERROR_OF_MEAN|2.04||0.001|TWO_SIDED|95.0|-10.76|-2.74||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the Incongruent STROOP Time to Complete (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-2.74|-10.76|0.0010
71110539|NCT02389465|141726771|OTHER|||||||0.19|||||||t-test, 2 sided|||IL10 levels in the placebo group pre- and post-treatment compared using a paired t-test||||.19
71062548|NCT01422213|141633404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.52|STANDARD_ERROR_OF_MEAN|2.02||0.0013|TWO_SIDED|95.0|-10.49|-2.54||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the Incongruent STROOP Time to Complete (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-2.54|-10.49|0.0013
71078065|NCT01026818|141664571|SUPERIORITY_OR_OTHER||LS Mean Differences|0.47|STANDARD_ERROR_OF_MEAN|1.0||0.637|TWO_SIDED|95.0|-1.5|2.45||P-value is for sexual relationship - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.45|-1.50|0.637
71078066|NCT01026818|141664571|SUPERIORITY_OR_OTHER||LS Mean Differences|0.17|STANDARD_ERROR_OF_MEAN|1.2||0.885|TWO_SIDED|95.0|-2.18|2.53||P-value is for sexual relationship - Month 13.5|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.53|-2.18|0.885
71078067|NCT01026818|141664571|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.04|STANDARD_ERROR_OF_MEAN|1.17||0.972|TWO_SIDED|95.0|-2.34|2.25||P-value is for sexual relationship - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.25|-2.34|0.972
71078068|NCT01026818|141664571|SUPERIORITY_OR_OTHER||LS Mean Differences|0.27|STANDARD_ERROR_OF_MEAN|0.55||0.621|TWO_SIDED|95.0|-0.81|1.36||P-value is for self-esteem - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.36|-0.81|0.621
71078069|NCT01026818|141664571|SUPERIORITY_OR_OTHER||LS Mean Differences|0.29|STANDARD_ERROR_OF_MEAN|0.54||0.598|TWO_SIDED|95.0|-0.78|1.35||P-value is for self-esteem - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.35|-0.78|0.598
71078070|NCT01026818|141664571|SUPERIORITY_OR_OTHER||LS Mean Differences|0.06|STANDARD_ERROR_OF_MEAN|0.59||0.923|TWO_SIDED|95.0|-1.1|1.21||P-value is for self-esteem - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.21|-1.10|0.923
71078071|NCT01026818|141664571|SUPERIORITY_OR_OTHER||LS Mean Differences|0.1|STANDARD_ERROR_OF_MEAN|0.58||0.857|TWO_SIDED|95.0|-1.03|1.24||P-value is for self-esteem - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.24|-1.03|0.857
71078072|NCT01026818|141664582|SUPERIORITY_OR_OTHER||LS Mean Differences|14.87|STANDARD_ERROR_OF_MEAN|5.57||0.008|TWO_SIDED|95.0|3.92|25.83||P-value is for Q1 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||25.83|3.92|0.008
71078073|NCT01026818|141664582|SUPERIORITY_OR_OTHER||LS Mean Differences|11.34|STANDARD_ERROR_OF_MEAN|5.45||0.038|TWO_SIDED|95.0|0.63|22.04||P-value is for Q1 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||22.04|0.63|0.038
71078074|NCT01026818|141664582|SUPERIORITY_OR_OTHER||LS Mean Differences|8.91|STANDARD_ERROR_OF_MEAN|6.15||0.148|TWO_SIDED|95.0|-3.18|21.0||P-value is for Q1 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||21.00|-3.18|0.148
71078075|NCT01026818|141664582|SUPERIORITY_OR_OTHER||LS Mean Differences|5.37|STANDARD_ERROR_OF_MEAN|6.03||0.373|TWO_SIDED|95.0|-6.48|17.23||P-value is for Q1 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||17.23|-6.48|0.373
71078076|NCT01026818|141664582|SUPERIORITY_OR_OTHER||LS Mean Differences|10.9|STANDARD_ERROR_OF_MEAN|4.96||0.029|TWO_SIDED|95.0|1.14|20.66||P-value is for Q1 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||20.66|1.14|0.029
71078077|NCT01026818|141664582|SUPERIORITY_OR_OTHER||LS Mean Differences|4.53|STANDARD_ERROR_OF_MEAN|4.91||0.357|TWO_SIDED|95.0|-5.12|14.17||P-value is for Q1 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||14.17|-5.12|0.357
71078078|NCT01026818|141664582|SUPERIORITY_OR_OTHER||LS Mean Differences|16.33|STANDARD_ERROR_OF_MEAN|5.42||0.003|TWO_SIDED|95.0|5.68|26.98||P-value is for Q2 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||26.98|5.68|0.003
71078079|NCT01026818|141664582|SUPERIORITY_OR_OTHER||LS Mean Differences|6.62|STANDARD_ERROR_OF_MEAN|5.3||0.212|TWO_SIDED|95.0|-3.8|17.04||P-value is for Q2 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||17.04|-3.80|0.212
71110540|NCT02389465|141726771|OTHER|||||||0.5|||||||t-test, 2 sided|||IL10 levels in the escitalopram group pre- and post-treatment compared using a paired t-test||||.5
71110541|NCT02389465|141726771|OTHER|||||||0.55|||||||t-test, 2 sided|||IL10 levels in the escitalopram + celecoxib group pre- and post-treatment compared using a paired t-test||||.55
71110542|NCT02389465|141726771|OTHER|||||||0.06|||||||t-test, 2 sided|||IL10 levels at completion of study compared between all MDD groups (placebo, escitalopram, and escitalopram + celecoxib) and the healthy control group||||.06
71110543|NCT00361972|141726815|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
71110544|NCT00361972|141726816|SUPERIORITY_OR_OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
71110545|NCT00503425|141726818|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Change from baseline in mean DAS28 was analyzed using paired t-test for course 1.|t-test, 2 sided|||||||<0.0001
71110546|NCT00503425|141726818|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Change from baseline in mean DAS28 was analyzed using paired t-test for course 2.|t-test, 2 sided|||||||<0.0001
71110547|NCT00503425|141726818|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Change from baseline in mean DAS28 was analyzed using paired t-test for course 3.|t-test, 2 sided|||||||<0.0001
71110548|NCT00503425|141726818|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Change from baseline in mean DAS28 was analyzed using paired t-test for course 4.|t-test, 2 sided|||||||0.0001
71110549|NCT00142792|141726829|SUPERIORITY_OR_OTHER|||||||0.18||||||Time by group interaction effect, F(2,372) = 1.8, p =0.18)|Mixed Models Analysis|A random intercept for each participant with a first-order antedependent covariance structure. Adjusted for site.||The study was powered to detect differences in FMA scores of a minimum effect size of 0.8 at a significance level of 0.01, the smallest effect size difference anticipated between Cyclic NMES and Cyclic Sensory Stimulation based on prior studies. A significance level of 0.01 in the power-analysis was taken since for each measurement occasion, three post-hoc tests are needed. To account for drop out of 20 % , the minimum number of participants required per group is 63.||||0.18
71110550|NCT00142792|141726829|SUPERIORITY||||||<|0.001||||||time effect, F(1,109)=87.7, p\<0.001)|Mixed Models Analysis|A random intercept for each participant with a first-order antedependent covariance structure. Adjusted for site.||||||<0.001
71110551|NCT00142792|141726830|SUPERIORITY_OR_OTHER|||||||0.27||||||time by group interaction effect, F(2,373) = 1.3, p =0.27|Mixed Models Analysis|A random intercept for each participant with a first-order antedependent covariance structure. Adjusted for site.||||||0.27
71062549|NCT01422213|141633405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.046|STANDARD_ERROR_OF_MEAN|0.012||0.0002|TWO_SIDED|95.0|-0.07|-0.02||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the SRT (Speed of Processing) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-0.02|-0.07|0.0002
71062550|NCT01422213|141633405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.029|STANDARD_ERROR_OF_MEAN|0.012||0.0157|TWO_SIDED|95.0|-0.05|-0.01||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the SRT (Speed of Processing) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-0.01|-0.05|0.0157
71062551|NCT01422213|141633406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.032|STANDARD_ERROR_OF_MEAN|0.009||0.0005|TWO_SIDED|95.0|-0.05|-0.01||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CRT (Attention) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-0.01|-0.05|0.0005
71110552|NCT00142792|141726830|SUPERIORITY||||||<|0.001||||||time effect, F(1,109)=91.1, p\<0.001|Mixed Models Analysis|A random intercept for each participant with a first-order antedependent covariance structure. Adjusted for site.||||||<0.001
71110553|NCT00437268|141726831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.431||||||The type 1 error rate was set at 0.20|Log Rank|||||||0.431
71110554|NCT00437268|141726832|SUPERIORITY_OR_OTHER_LEGACY|||||||0.593|||||||Fisher Exact|||||||0.593
71110555|NCT00437268|141726833|SUPERIORITY_OR_OTHER_LEGACY|||||||0.157|||||||Log Rank|||||||0.157
71110556|NCT00437268|141726834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.539||||||Kaplan-Meier analysis was used for statistical analysis.|Log Rank|||||||0.539
71062552|NCT01422213|141633406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.009||0.3549|TWO_SIDED|95.0|-0.03|0.01||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CRT (Attention) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||0.01|-0.03|0.3549
71110557|NCT00437268|141726835|SUPERIORITY_OR_OTHER_LEGACY|||||||0.695|||||||Fisher Exact|||||||0.695
71110558|NCT00444925|141726837|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine versus (vs) placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the fifth (5th) and ninety-fifth (95th) percentile, respectively).||||<0.0001
71110559|NCT00444925|141726837|SUPERIORITY_OR_OTHER|||||||0.0107||95.0||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment Difference Tolterodine ER vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0107
71117646|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
71110560|NCT00444925|141726837|SUPERIORITY_OR_OTHER|||||||0.0172||95.0||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0172
71110561|NCT00444925|141726838|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine vs placebo at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
71110562|NCT00444925|141726838|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Tolterodine ER vs placebo at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
71110563|NCT00444925|141726838|SUPERIORITY_OR_OTHER|||||||0.846||95.0|||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.8460
71110564|NCT00444925|141726838|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine vs placebo at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
71110565|NCT00444925|141726838|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Tolterodine ER vs placebo at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
71110566|NCT00444925|141726838|SUPERIORITY_OR_OTHER|||||||0.1937||95.0|||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.1937
71110567|NCT00444925|141726839|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||<0.0001
71110568|NCT00444925|141726839|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||<0.0001
71110569|NCT00444925|141726839|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
71110570|NCT00444925|141726839|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
71110571|NCT00444925|141726839|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
71110572|NCT00444925|141726839|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 12.||||<0.0001
71110573|NCT00444925|141726839|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.0220
70937031|NCT01277302|141373934|SUPERIORITY_OR_OTHER||Estimated interaction effect|0.071|STANDARD_ERROR_OF_MEAN|0.107||0.5091||||||This is the p-value of the treatment by time interaction in the longitudinal model. Analysis was not adjusted for multiple comparisons as there was only 1 comparison. p \< 0.05 (2-sided) was required for significance.|Longitudinal mixed model|The analysis was stratified by disease (BRVO or CRVO), randomization month, and randomization BCVA score category (≤35, \>35 to ≤50, or \>50 letters).||The null hypothesis was that there was no difference in the trend of change from Baseline in the visual acuity scores from Month 7 to Month 15 between the 2 treatment groups as assessed by the interaction term of treatment by time in a longitudinal model.||||0.5091
70937032|NCT00731692|141373943|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.95||||0.544|TWO_SIDED|95.0|0.8|1.12|||Regression, Cox|||||1.12|0.80|0.544
71062553|NCT01422213|141633407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|0.89|<|0.0001|TWO_SIDED|95.0|-6.45|-2.96||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the MADRS Total Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-2.96|-6.45|<0.0001
71062554|NCT01422213|141633407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|0.88|<|0.0001|TWO_SIDED|95.0|-8.43|-4.98||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the MADRS Total Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-4.98|-8.43|<0.0001
71062555|NCT01422213|141633408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.88|-0.42||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CGI-S Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-0.42|-0.88|<0.0001
71062556|NCT01422213|141633408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.08|-0.62||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CGI-S Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-0.62|-1.08|<0.0001
71062557|NCT01422213|141633409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.81|-0.4||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CGI-I Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site and treatment-by-visit interaction.||-0.40|-0.81|<0.0001
71062558|NCT01422213|141633409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.06|-0.65||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CGI-I Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site and treatment-by-visit interaction.||-0.65|-1.06|<0.0001
71062559|NCT01422213|141633410|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.0002|TWO_SIDED|95.0|1.44|3.33||Wald's Test. No adjustment for multiplicity was made.|Regression, Logistic|||||3.33|1.44|0.0002
71062560|NCT01422213|141633410|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.43|||<|0.0001|TWO_SIDED|95.0|2.26|5.21||Wald's Test. No adjustment for multiplicity was made.|Regression, Logistic|||||5.21|2.26|<0.0001
71062561|NCT01422213|141633411|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.09||||0.003|TWO_SIDED|95.0|1.29|3.41||Wald's Test. No adjustment for multiplicity was made.|Regression, Logistic|||||3.41|1.29|0.0030
71062562|NCT01422213|141633411|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.13|||<|0.0001|TWO_SIDED|95.0|1.95|5.03||Wald's Test. No adjustment for multiplicity was made.|Regression, Logistic|||||5.03|1.95|<0.0001
71062563|NCT01422213|141633412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.059||0.0393|TWO_SIDED|95.0|0.01|0.24||No adjustment for multiplicity was made.|ANCOVA|||||0.24|0.01|0.0393
71062564|NCT01422213|141633413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.068||0.0007|TWO_SIDED|95.0|0.1|0.36||No adjustment for multiplicity was made.|ANCOVA|||||0.36|0.10|0.0007
71110574|NCT00444925|141726840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.8|STANDARD_ERROR_OF_MEAN|3.4||0.0214|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference Least Squares Mean (LSMean) Difference Standard Error (SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||0.0214
71110575|NCT00444925|141726840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.2|STANDARD_ERROR_OF_MEAN|3.4||0.0149|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||0.0149
71062565|NCT01422213|141633413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.068||0.0246|TWO_SIDED|95.0|0.02|0.29||No adjustment for multiplicity was made.|ANCOVA|||||0.29|0.02|0.0246
71062566|NCT03197389|141633415|OTHER||Median Difference (Net)|0.0|||||TWO_SIDED|||||||||||||
71062567|NCT04129125|141633416|OTHER|The study sample size of 260 subjects was selected to have at least 90 percent power for primary safety and efficacy endpoints and all-cause mortality|Event rate|83.4|||<|0.0001|TWO_SIDED|95.0|78.0|88.0||The p-value a priori threshold for statistical significance was \<0.025|Fisher Exact|||The FDA agreed performance goal for the primary efficacy endpoint was for the lower bound of the two-sided 95% CI to be \>69%||88|78|<0.0001
71062568|NCT04129125|141633417|OTHER|The study sample size of 260 subjects was selected to have at least 90 percent power for primary safety and efficacy endpoints and all-cause mortality|Event rate|1.9|||||TWO_SIDED|95.0|0.6|4.4||||||The FDA agreed performance goal for the primary safety endpoint was for the observed rate to be ≤6.0%||4.4|0.6|
71110576|NCT00444925|141726840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|2.7||0.8659|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.8659
70937033|NCT00108355|141373976|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Log Rank|||Initial estimation: median time to recurrence of ascites of 38 days in the study group and 20 days in the control group in a fixed duration of 6 months (5% type-I error (2 sided) and an 80% power). However, due to low accrual and based on randomized trials using vasoconstrictors in the prevention of PCD and a study that showed that midodrine leads to a significant improvement in effective arterial blood volume, each of which had sample sizes of 24-25 patients,we decided on a sample size of 30.||||<0.05
70937034|NCT00413283|141373980|SUPERIORITY_OR_OTHER|||||||0.972|||||||Satterthwaite t-test|||||||0.972
70937035|NCT00413283|141373980|SUPERIORITY_OR_OTHER|||||||0.725|||||||Satterthwaite t-test|||||||0.725
70937036|NCT00413283|141373980|SUPERIORITY_OR_OTHER|||||||0.312|||||||Satterthwaite t-test|||||||0.312
70937037|NCT00413283|141373981|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
70937038|NCT00413283|141373981|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
71062569|NCT04129125|141633418|OTHER|The study sample size of 260 subjects was selected to have at least 90 percent power for primary safety and efficacy endpoints and all-cause mortality|Event rate|84.0||||0.0001|TWO_SIDED|95.0|78.0|89.0||The p-value a priori threshold for statistical significance was \<0.025|Fisher Exact|||The FDA agreed performance goal for the primary efficacy endpoint was for the lower bound of the two-sided 95% CI to be \>69%||89|78|0.0001
71062570|NCT04129125|141633419|OTHER|The study sample size of 260 subjects was selected to have at least 90 percent power for primary safety and efficacy endpoints and all-cause mortality|Event rate|0.9|||||TWO_SIDED|95.0|0.1|3.4||||||The FDA agreed performance goal for the primary safety endpoint was for the observed rate to be ≤6.0%||3.4|0.1|
71062571|NCT04129125|141633428|OTHER|The study sample size of 260 subjects was selected to have at least 90 percent power for primary safety and efficacy endpoints and all-cause mortality|Event rate|12.7|||||TWO_SIDED|95.0|8.5|16.7|||||Event and CI estimated using Kaplan-Meier method|The FDA agreed performance goal for the all-cause mortality endpoint was for the observed rate to be ≤20.3%||16.7|8.5|
71062572|NCT04129125|141633439|OTHER|The study sample size of 260 subjects was selected to have at least 90 percent power for primary safety and efficacy endpoints and all-cause mortality|Event rate|12.3|||||TWO_SIDED|95.0|8.1|17.2|||||Event and CI estimated using Kaplan-Meier method|The FDA agreed performance goal for the primary safety endpoint was for the observed rate to be ≤20.3%||17.2|8.1|
71062573|NCT02723344|141633469|OTHER|||||||0.056|||||||Wilcoxon-rank sum|||||||.056
71062574|NCT02723344|141633470|OTHER|||||||0.26||||||Wilcoxon Rank-Sum|Wilcoxon (Mann-Whitney)|||||||.26
70937039|NCT00413283|141373981|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
70937040|NCT00413283|141373982|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
70937041|NCT00413283|141373982|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
70937042|NCT00413283|141373982|SUPERIORITY_OR_OTHER|||||||0.342|||||||Fisher Exact|||||||0.342
70937043|NCT00413283|141373983|SUPERIORITY_OR_OTHER|||||||0.454|||||||Satterthwaite t-test|||||||0.454
70937044|NCT00413283|141373983|SUPERIORITY_OR_OTHER|||||||0.101|||||||Satterthwaite t-test|||||||0.101
70937045|NCT00413283|141373983|SUPERIORITY_OR_OTHER|||||||0.199|||||||Satterthwaite t-test|||||||0.199
70937046|NCT00413283|141373984|SUPERIORITY_OR_OTHER|||||||0.662|||||||Fisher Exact|||||||0.662
70937047|NCT00413283|141373984|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
70937048|NCT00413283|141373984|SUPERIORITY_OR_OTHER|||||||0.662|||||||Fisher Exact|||||||0.662
71062575|NCT02723344|141633472|OTHER|||||||0.64|||||||Wilcoxon Rank-Sum|||||||.64
71062576|NCT03473184|141633479|OTHER|p-values are from an ANOVA of the average numerical score (sum of erythema and edema) at 24 and 48 hours post irradiation (Days 3 and 4) with effects of subject and treatment, using Fisher's least significant differences.||||||1|||||||ANOVA|||Irradiated vehicle and untreated irradiated sites versus irradiated diacerein site, and non-irradiated vehicle site versus non-irradiated diacerein site and untreated irradiated site versus irradiated vehicle site.||||1.0000
71110577|NCT00444925|141726840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.5|STANDARD_ERROR_OF_MEAN|4.0|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
71110578|NCT00444925|141726840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7|STANDARD_ERROR_OF_MEAN|4.0||0.0036|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||0.0036
70937049|NCT00246129|141373986|SUPERIORITY|||||||0.467|||||||Log Rank|||||||0.467
70937050|NCT00246129|141373987|SUPERIORITY|||||||0.138|||||||Log Rank|||||||0.138
70937051|NCT02005172|141374006|EQUIVALENCE|The primary analysis used the TOST procedure for equivalence. A difference of less than 10% between devices on the proportion of diagnostic days during the monitoring period was considered to be equivalent. We hypothesized that the percentage of diagnostic days for the ELR and the KM would be 20% and 15%, respectively.||||||||||||||||For the primary endpoint, equivalence testing using the two one-sided test procedure was used to compare the proportion of (unpaired) days in which a diagnostic recording was made with each device during the monitoring period. For the purpose of this study, a difference of less than 10% between devices on the rate of detection of arrhythmias was taken to indicate equivalence.|"Descriptive statistics (means, standard deviation (SD), percentages) were used to summarize the demographic and clinical characteristics of the patients. The total number of tracings and the percentage of tracings with arrhythmias for each device were also calculated.~For the primary endpoint, equivalence testing using the two one-sided test (TOST) procedure was used to compare the proportion of (unpaired) days in which a diagnostic recording was made with each device during the monitoring period. Patients were asked to use both devices for the same duration. For the purpose of this study, a difference of less than 10% between devices on the rate of detection of arrhythmias was taken to indicate equivalence. The primary hypothesis was that the KM"|||
70937052|NCT01853384|141374010|SUPERIORITY_OR_OTHER|||||||0.5348||||||Analysis adjusted for sites, with significance being at P \< 0.05|Cochran-Mantel-Haenszel|||||||.5348
71062577|NCT03473184|141633479|OTHER|p-values are from an ANOVA of the average numerical score (sum of erythema and edema) at 24 and 48 hours post irradiation (Days 3 and 4) with effects of subject and treatment, using Fisher's least significant differences.||||||0.0008|||||||ANOVA|||Non-irradiated diacerein and vehicle sites versus irradiated diacerein site, and irradiated vehicle and untreated irradiated sites versus non-irradiated diacerein site, and non-irradiated vehicle site versus irradiated vehicle site, and untreated irradiated site versus non-irradiated vehicle site.||||0.0008
71062578|NCT02964247|141633480|SUPERIORITY||Treatment difference|-0.68|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.89|-0.48|||pattern mixture model||Liraglutide - Placebo|Statistical analysis for the primary estimand. Primary estimand: treatment effect (effectiveness) based on the FAS using week 26 measurements from the in-trial observation period. The change in HbA1c from baseline to week 26 were analysed using a pattern mixture model with multiple imputation to impute missing data, with treatment, country and the stratification factor (metformin use at baseline: yes vs. no) as categorical fixed effects and baseline HbA1c as covariate.||-0.48|-0.89|<.001
71062579|NCT02964247|141633480|SUPERIORITY|Test was not controlled for type I error. Secondary estimand: treatment effect (efficacy) based on the FAS using post baseline measurements up to and including week 26 from the on-treatment without rescue medication obs. period.|Treatment difference|-0.74|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.94|-0.53|||Mixed Models Analysis||Liraglutide - Placebo|Statistical analysis for the secondary estimand.The change in HbA1c from baseline up to and including week 26 at scheduled time points were analysed using MMRM with treatment, country and the stratification factor (metformin use at baseline: yes vs. no) as categorical fixed effects and baseline HbA1c as covariate, all nested within visit.||-0.53|-0.94|<.001
71062580|NCT02964247|141633481|SUPERIORITY||Treatment difference|-0.82|STANDARD_ERROR_OF_MEAN|0.46||0.077|TWO_SIDED|95.0|-1.73|0.09|||pattern mixture model||Liraglutide - Placebo|Statistical analysis for the primary estimand. Primary estimand: treatment effect (effectiveness) based on the FAS using week 26 measurements from the in-trial observation period. The change in body weight from baseline to week 26 were analysed using a pattern mixture model with multiple imputation to impute missing data, with treatment, country and the stratification factor (metformin use at baseline: yes vs. no) as categorical fixed effects and baseline body weight as covariate.||0.09|-1.73|0.077
71062581|NCT02964247|141633481|SUPERIORITY|Test was not controlled for type I error. Secondary estimand: treatment effect (efficacy) based on the FAS using post baseline measurements up to and including week 26 from the on-treatment without rescue medication obs. period.|Treatment difference|-0.86|STANDARD_ERROR_OF_MEAN|0.46||0.062|TWO_SIDED|95.0|-1.77|0.04|||Mixed Models Analysis||Liraglutide - Placebo|Statistical analysis for the secondary estimand. The change in body weight from baseline up to and including week 26 at scheduled time points were analysed using MMRM with treatment, country and the stratification factor (metformin use at baseline: yes vs. no) as categorical fixed effects and baseline body weight as covariate, all nested within visit.||0.04|-1.77|0.062
71062582|NCT03832686|141633514|OTHER|||||||0.86||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||||||0.86
71062583|NCT03832686|141633515|OTHER|||||||0.69||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||||||0.69
71062584|NCT03832686|141633516|OTHER|||||||0.47||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||Comparison of Eating in Public Score||||0.47
71062585|NCT03832686|141633516|OTHER|||||||0.73||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||Comparison of Normalcy of Diet score||||0.73
71062586|NCT03832686|141633517|OTHER|||||||0.65||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||Comparison of MBSImP Oral score||||0.65
71062587|NCT03832686|141633517|OTHER|||||||0.24||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||Comparison of MBSImP Pharyngeal score||||0.24
71062588|NCT03832686|141633518|OTHER|||||||0.53||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||||||0.53
71110579|NCT00444925|141726840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|3.3||0.1484|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.1484
71110580|NCT00444925|141726840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.1|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
70852510|NCT01433289|141193706|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||The study hypothesis tested whether Polyphenon E given twice daily for 14 days at the specified doses has an effect on antiviral activity compared with placebo, measured by differences from baseline to day 14 in plasma HIV-1 RNA level (log10 copies/mL). The Wilcoxon signed-rank test was used to test the null hypothesis that there was no change at Day 14 versus baseline.||||>0.05
70937053|NCT01853384|141374011|SUPERIORITY_OR_OTHER|||||||0.9456|||||||Regression, Cox|||||||.9456
71062589|NCT03832686|141633519|OTHER|||||||0.5||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||||||0.50
71062590|NCT01609790|141633521|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98|||||||Z-test|One-sided test, significance level 0.15||Assuming a 36% 6-month (6m) rate in the placebo arm \[from the March 2009 Food and Drug Administration (FDA) briefing\], a 55% rate in the AMG 386 arm, and an exponential distribution corresponds to median PFS of 4.1 and 7 months, respectively, with a hazard ratio of 0.59 (AMG 386 arm vs. placebo arm). A total of 114 patients (57 per arm) will yield 85% power to detect an absolute 19% difference of 6m PFS rate at a 1-sided alpha level of 0.15 based on a 2-sample proportion test.||||0.98
71062591|NCT01609790|141633522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.85|||||||Chi-squared|||||||0.85
71062592|NCT01609790|141633523|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.46||||0.09|TWO_SIDED|95.0|0.95|2.27|||Log Rank|||||2.27|0.95|0.09
71110581|NCT00444925|141726840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|STANDARD_ERROR_OF_MEAN|4.1||0.1029|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||0.1029
71062593|NCT01609790|141633524|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.51||||0.04|TWO_SIDED|95.0|1.02|2.24|||Log Rank|||||2.24|1.02|0.04
70852511|NCT01433289|141193706|SUPERIORITY|||||||0.74||||||Analysis was stratified by treatment group. The Kruskal-Wallis test was used to compare the change of log10 HIV-1 RNA copies/ml between treatment groups.|Kruskal-Wallis|||||||0.74
71062594|NCT01609790|141633525|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7|||||||Chi-squared|||||||0.7
71062595|NCT01662635|141633539|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Continuous variables were summarized as arithmetic means, medians and standard deviations; and categorical variables were reported as proportions with 95% confidence intervals. Inferential comparisons were performed using Student's t test. The x2 or Fisher's exact tests were used to assess significance among categorical variables.||||< 0.05
71062596|NCT00838903|141633566|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.91|||||TWO_SIDED|95.0|-1.16|-0.65|||ANCOVA|||||-0.65|-1.16|
71062597|NCT00838903|141633566|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35|||||TWO_SIDED|95.0|-0.53|-0.17|||ANCOVA|||||-0.17|-0.53|
71062598|NCT00838903|141633566|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27|||||TWO_SIDED|95.0|-0.45|-0.09|||ANCOVA|||||-0.09|-0.45|
71062599|NCT00838903|141633566|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value is for superiority testing of albiglutide over placebo at 0.05 level.|t-test, 2 sided|The p-value is from a two-sided t-test to test whether the difference of least square means (albiglutide - placebo) is equal to zero||||||<0.0001
70937054|NCT01853384|141374013|SUPERIORITY_OR_OTHER|||||||0.6194||||||Treatment Week 01|Cochran-Mantel-Haenszel|||||||.6194
70937055|NCT01853384|141374013|SUPERIORITY_OR_OTHER|||||||0.793||||||Treatment Week 02|Cochran-Mantel-Haenszel|||||||.7930
70937056|NCT01853384|141374013|SUPERIORITY_OR_OTHER|||||||0.3362||||||Treatment Week 03|Cochran-Mantel-Haenszel|||||||0.3362
71062600|NCT00838903|141633566|NON_INFERIORITY_OR_EQUIVALENCE|To test whether the difference of least square means (albiglutide - sitagliptin) is equal to the pre-specified non-inferiority margin of 0.3%.|||||<|0.0001||||||The p-value is for non-inferiority testing of albiglutide versus sitagliptin at 0.0125 level.|t-test, 1 sided|||||||<0.0001
71062601|NCT00838903|141633566|NON_INFERIORITY_OR_EQUIVALENCE|To test whether the difference of least square means (albiglutide - glimepiride) is equal to the pre-specified non-inferiority margin of 0.3%.|||||<|0.0001||||||The p-value is for non-inferiority testing of albiglutide versus glimepiride at 0.0125 level.|t-test, 1 sided|||||||<0.0001
71062602|NCT00838903|141633566|SUPERIORITY_OR_OTHER|||||||0.0001||||||The p-value is for superiority testing of albiglutide versus sitagliptin at 0.025 level.|t-test, 2 sided|The p-value is from a two-sided t-test to test whether the difference of least square means (albiglutide - sitagliptin) is equal to zero.||||||0.0001
71062603|NCT00838903|141633566|SUPERIORITY_OR_OTHER|||||||0.0033||||||The p-value is for superiority testing of albiglutide versus glimepiride at 0.025 level.|t-test, 2 sided|The p-value is from a two-sided t-test to test whether the difference of least square means (albiglutide - glimepiride) is equal to zero.||||||0.0033
71062604|NCT03096314|141633576|SUPERIORITY|||||||0.26|||||||Generalized linear model|||||||0.26
71062605|NCT03096314|141633577|SUPERIORITY||Risk Difference (RD)|4.3|||||TWO_SIDED|95.0|-0.1|8.6||||||||8.6|-0.1|
71062606|NCT03096314|141633578|SUPERIORITY||Risk Difference (RD)|3.7|||||TWO_SIDED|95.0|-0.5|8.0||||||||8.0|-0.5|
71062607|NCT03096314|141633579|SUPERIORITY||Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-5.4|6.0||||||||6.0|-5.4|
71062608|NCT03096314|141633580|SUPERIORITY||Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-2.7|0.0||||||||0.0|-2.7|
71062609|NCT03096314|141633581|SUPERIORITY||Mean Difference (Final Values)|-2.2|||||TWO_SIDED|95.0|-4.8|0.4||||||||0.4|-4.8|
71062610|NCT03096314|141633582|SUPERIORITY||Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-2.1|0.5||||||||0.5|-2.1|
71062611|NCT03096314|141633583|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|0.0|0.1||||||||0.1|0|
71062612|NCT03096314|141633584|SUPERIORITY||Risk Difference (RD)|0.7|||||TWO_SIDED|95.0|-2.1|3.6||||||||3.6|-2.1|
71062613|NCT03096314|141633585|SUPERIORITY||Risk Difference (RD)|6.5|||||TWO_SIDED|95.0|-22.0|34.9||||||Mild ARDS||34.9|-22.0|
71062614|NCT03096314|141633585|SUPERIORITY||Risk Difference (RD)|-25.6|||||TWO_SIDED|95.0|-56.3|5.1||||||Moderate ARDS||5.1|-56.3|
71062615|NCT03096314|141633585|SUPERIORITY||Risk Difference (RD)|19.1|||||TWO_SIDED|95.0|-2.9|41.1||||||Severe ARDS||41.1|-2.9|
71062616|NCT03096314|141633586|SUPERIORITY||Risk Difference (RD)|-1.1|||||TWO_SIDED|95.0|-7.3|5.0||||||No AKI||5.0|-7.3|
71062617|NCT03096314|141633586|SUPERIORITY||Risk Difference (RD)|-1.1|||||TWO_SIDED|95.0|-5.6|3.4||||||Mild AKI||3.4|-5.6|
71062618|NCT03096314|141633586|SUPERIORITY||Risk Difference (RD)|-0.6|||||TWO_SIDED|95.0|-4.4|3.2||||||Moderate AKI||3.2|-4.4|
71062619|NCT03096314|141633586|SUPERIORITY||Risk Difference (RD)|2.8|||||TWO_SIDED|95.0|-1.7|7.3||||||Severe AKI||7.3|-1.7|
71062620|NCT03096314|141633587|SUPERIORITY||Risk Difference (RD)|0.5|||||TWO_SIDED|95.0|-1.9|2.9||||||||2.9|-1.9|
71062621|NCT03096314|141633588|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.2|0.1||||||||0.1|-0.2|
71062622|NCT03096314|141633589|SUPERIORITY||Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-4.4|5.1||||||||5.1|-4.4|
71062623|NCT03096314|141633590|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.3|0.0||||||||0.0|-0.3|
71062624|NCT03096314|141633591|SUPERIORITY||Mean Difference (Final Values)|35.5|||||TWO_SIDED|95.0|31.5|39.6||||||||39.6|31.5|
71062625|NCT03096314|141633592|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
71062626|NCT03096314|141633593|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
71062627|NCT03096314|141633594|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.51
71062628|NCT03096314|141633595|SUPERIORITY|||||||0.25|||||||Fisher Exact|||||||0.25
71062629|NCT03096314|141633596|SUPERIORITY|||||||0.69|||||||Chi-squared|||||||0.69
71062630|NCT03096314|141633597|SUPERIORITY|||||||0.24|||||||Chi-squared|||||||0.24
71062631|NCT01062425|141633620|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||||||One-sided test with significance level of 0.15.|Z-test|||The null hypothesis was that the 6m PFS rates for both arms are 50%, and the alternative hypothesis was that patients receiving the experimental regimen would have a 6-month PFS rate of 66%. With 150 eligible patients, there would be an 80% statistical power to detect the 16% absolute increase in 6m PFS at a significance level of 0.15, using a one-sided Z test for two proportions.||||0.005
71110582|NCT00444925|141726840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.4|STANDARD_ERROR_OF_MEAN|3.3||0.0048|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.0048
71110583|NCT00444925|141726841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0002|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||0.0002
71062632|NCT01062425|141633621|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.44|TWO_SIDED|95.0|0.6|1.24||Significance level 0.05, two-sided test.|Log Rank||Placebo is the reference arm for the hazard ratio.|||1.24|0.6|0.44
71062633|NCT01062425|141633621|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.648|TWO_SIDED|95.0|0.62|1.34|||Regression, Cox||Placebo is reference level for the hazard ratio.|Multivariate analysis with the Cox proportional hazard model for overall survival was performed with the stratification variables as fixed variables to assess the treatment effect adjusting patient-specific risk factors. The covariates evaluated for the multivariate models were assigned protocol treatment, MGMT methylation status, and RPA risk class.||1.34|0.62|0.648
71062634|NCT01062425|141633622|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.67||||0.03|TWO_SIDED|95.0|0.47|0.95||Significance level 0.05, two-sided test.|Log Rank||Placebo is the reference arm for the hazard ratio.|||0.95|0.47|0.03
71062635|NCT01062425|141633622|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.67||||0.036|TWO_SIDED|95.0|0.46|0.97|||Regression, Cox||Placebo is the reference arm.|Multivariate analysis with the Cox proportional hazard model for progression-free survival was performed with the stratification variables as fixed variables to assess the treatment effect adjusting patient-specific risk factors. The covariates evaluated for the multivariate models were assigned protocol treatment, MGMT methylation status, and recursive partitioning analysis (RPA) risk class.||0.97|0.46|0.036
71062636|NCT01062425|141633623|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||||||Significance level 0.05, two-sided test.|Chi-squared|||||||0.02
71062637|NCT03003962|141633624|OTHER|"The analysis was performed using the stratified log-rank test, adjusting for PD-L1 expression (TC 25% to 49% versus \>= 50%) and histology and smoking status (squamous vs. non-squamous + never smoker vs.~non-squamous + former/current smoker) and using the rank tests of association approach."|Hazard Ratio (HR)|0.84||||0.037|TWO_SIDED|95.0|0.706|0.989|||Stratified Log-rank test||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model|||0.989|0.706|0.037
71062638|NCT03003962|141633625|OTHER|"The analysis was performed using the stratified log-rank test, adjusting for PD-L1 expression (TC 25% to 49% versus \>= 50%) and histology and smoking status (squamous vs. non-squamous + never smoker vs.~non-squamous + former/current smoker) and using the rank tests of association approach."|Hazard Ratio (HR)|0.96||||0.628|TWO_SIDED|95.0|0.793|1.151|||Stratified log-rank test||The HR and CI were calculated using a stratified Cox proportional hazards model.|||1.151|0.793|0.628
71062639|NCT02069015|141633670|SUPERIORITY||Mean Difference|0.05|||<|0.001|TWO_SIDED|95.0|-4.781|6.906|||paired t-test|||||6.906|-4.781|<0.001
70937057|NCT01853384|141374013|SUPERIORITY_OR_OTHER|||||||0.5263||||||Treatment Week 04|Cochran-Mantel-Haenszel|||||||0.5263
70937058|NCT01853384|141374013|SUPERIORITY_OR_OTHER|||||||0.1997||||||Treatment Week 05|Cochran-Mantel-Haenszel|||||||0.1997
71062640|NCT01108718|141633678|SUPERIORITY_OR_OTHER||Rate of Preference|0.45|STANDARD_DEVIATION|0.5|>|0.1|TWO_SIDED|95.0|0.43|0.47|||McNemar||Rate of preference refers specifically to Tempur-Pedic Mattress.|h0: Rate Preference Tempur-pedic mattress = Rate Preference control mattress h1: Rate Preference Tempur-pedic mattress = Rate Preference control mattress||.47|.43|>0.1
71062641|NCT01805089|141633694|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71062642|NCT03762265|141633697|SUPERIORITY||Difference in percentage|5.73|STANDARD_ERROR_OF_MEAN|7.535||0.4469|TWO_SIDED|95.0|-9.037|20.5|||Cochran-Mantel-Haenszel|||P-value and 95% confidence interval (CI) were based on Cochran-Mantel-Haenszel general association test stratified by disease type (PV or PF) and disease history (newly diagnosed \[\<=6 months prior to screening\] or relapsing \[diagnosed greater than \[\>\] 6 months prior to screening\]).||20.500|-9.037|0.4469
71062643|NCT03762265|141633698|SUPERIORITY||Difference in percentage|8.13|STANDARD_ERROR_OF_MEAN|7.085||0.251|TWO_SIDED|95.0|-5.752|22.019|||Cochran-Mantel-Haenszel|||P-value and 95% CI were based on Cochran-Mantel-Haenszel general association test stratified by disease type (PV or PF) and disease history (newly diagnosed \[\<=6 months prior to screening\] or relapsing \[diagnosed \>6 months prior to screening\]).||22.019|-5.752|0.2510
71062644|NCT00806403|141633740|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Fisher Exact|||Null hypothesis:there is no difference in ST resolution at 120 minutes after inclusion between thrombolysis and primary PCI. The power calculation was based on the aim to prove a 50% reduction of failure to achive at least a 50% ST resolution (40% failure in thrombolysis group and 20% failure in Primary PCI group). With a power of 80% and a significance level of 0.05 (2-sided test), a total of 166 patients would be required.||||0.56
71062645|NCT00806403|141633741|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
71062646|NCT00806403|141633742|SUPERIORITY_OR_OTHER|||||||0.04|||||||Fisher Exact|||Null hypothesis:there is no difference in number of patients with TIMI 3 flow at 5-7 days after inclusion between thrombolysis and primary PCI. The power calculation was based on the aim to prove a 65% reduction of failure to achive TIMI 3 flow (30% failure in thrombolysis group and 10% failure in Primary PCI group). With a power of 90% and a significance level of 0.05 (2-sided test), a total of 180 patients would be required.||||0.04
70937059|NCT01853384|141374013|SUPERIORITY_OR_OTHER|||||||0.1617||||||Treatment Week 06|Cochran-Mantel-Haenszel|||||||0.1617
70937060|NCT01853384|141374013|SUPERIORITY_OR_OTHER|||||||0.2611||||||Treatment Week 07|Cochran-Mantel-Haenszel|||||||0.2611
71062647|NCT00806403|141633743|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Fisher Exact|||||||0.50
71110584|NCT00444925|141726841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.0006|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||0.0006
70852512|NCT03241368|141193710|OTHER|Comparative - This purpose of this study is to evaluate performance of the PillCam Crohn's capsule \[referred to as capsule endoscopy (CE)\] as compared to IC with MRE.||||||0.125|||||||McNemar|Exact McNemar's test||This was a 1-arm, non-powered study. Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) was estimated for each treatment group, along with the 95% confidence interval. The difference between treatment groups in Sensitivity and Specificity was compared.||||0.125
70937061|NCT01853384|141374013|SUPERIORITY_OR_OTHER|||||||0.7232||||||Treatment Week 08|Cochran-Mantel-Haenszel|||||||0.7232
71062648|NCT00806403|141633744|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Fisher Exact|||||||0.21
71062649|NCT02857816|141633762|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||This is a single arm study. The primary objective was to demonstrate a statistically significant reduction between baseline and following the 12th PTNM therapy sessions in the number of UUI episodes per day.||||<0.0001
71062650|NCT01787292|141633766|SUPERIORITY|||||||0.001||||||To account for sequence carryover, we employed analysis of covariance inclusive of sequence by period covariates against treatment effects.|ANCOVA|Least square means were adjusted for carryover from the crossover design and between subjects effects were analyzed using Kenward-Roger df estimation||||||.001
71062651|NCT01787292|141633767|SUPERIORITY|||||||0.8|||||||ANCOVA|||To account for sequence carryover, we employed analysis of covariance inclusive of sequence by period covariates against treatment effects.||||.8
71062652|NCT01787292|141633768|SUPERIORITY|||||||0.05||||||To account for sequence carryover, we employed analysis of covariance inclusive of sequence by period covariates against treatment effects.|ANCOVA|||||||.05
71062653|NCT01787292|141633769|SUPERIORITY|||||||0.05||||||To account for sequence carryover, we employed analysis of covariance inclusive of sequence by period covariates against treatment effects.|ANCOVA|A Kenward-Rogers adjustment for degrees of freedom was made to account for carryover effects.||||||.05
71062654|NCT01787292|141633770|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||.01
71062655|NCT01787292|141633771|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||.01
71062656|NCT01787292|141633772|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||.01
71062657|NCT01787292|141633773|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||.5
71062658|NCT01787292|141633774|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|A Kenward-Rogers adjustment for df was made to account for carryover effects.||||||.6
71062659|NCT01787292|141633775|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||.4
71062660|NCT01787292|141633776|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||.05
71062661|NCT01787292|141633777|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||.25
71062662|NCT01787292|141633778|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||.01
71062663|NCT01597778|141633796|SUPERIORITY||Difference in Kaplan-Meier estimates|6.1||||0.4092|TWO_SIDED|95.0|-5.2|17.4||Statistical significance was determined using a pre-specified threshold of 0.05. Final p-value is adjusted for the interim looks per study design.|Z-test to compare the Kaplan-Meier Est.|||The primary null hypothesis of the study is that there is no difference between the 2 year PFS probabilities for dUCB vs. haplo-BM.||17.4|-5.2|0.4092
71062664|NCT01597778|141633796|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.06|TWO_SIDED|95.0|0.99|1.7||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||The null hypothesis of the study is that there is no difference between the 2 year PFS probabilities for dUCB vs. haplo-BM after adjustment for age, performance score, and disease type.||1.70|0.99|0.060
71062665|NCT01597778|141633798|SUPERIORITY|||||||0.046||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death before neutrophil recovery is competing risk.||The null hypothesis is that there is no difference between the neutrophil engraftment post-transplantation for dUCB vs. haplo-BM.||||0.046
71062666|NCT01597778|141633799|SUPERIORITY|||||||0.16||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death before Platelet recovery is competing risk.||The null hypothesis is that there is no difference between the platelet engraftment to 20k post-transplantation for dUCB vs. haplo-BM.||||0.160
70852513|NCT04343235|141193735|SUPERIORITY|||||||0.21|||||||Fisher Exact|||||||0.21
70937062|NCT01853384|141374013|SUPERIORITY_OR_OTHER|||||||0.4405||||||Treatment Week 09|Cochran-Mantel-Haenszel|||||||0.4405
70937063|NCT01853384|141374013|SUPERIORITY_OR_OTHER|||||||0.3516||||||Treatment Week 10|Cochran-Mantel-Haenszel|||||||0.3516
70852514|NCT04343235|141193736|SUPERIORITY|||||||0.7||||||Main effect for Randomization group|ANOVA|||||||0.70
70937064|NCT01853384|141374013|SUPERIORITY_OR_OTHER|||||||0.2821||||||Treatment Week 11|Cochran-Mantel-Haenszel|||||||0.2821
70937065|NCT01853384|141374013|SUPERIORITY_OR_OTHER|||||||0.3722||||||Treatment Week 12|Cochran-Mantel-Haenszel|||||||0.3722
71062667|NCT01597778|141633799|SUPERIORITY|||||||0.146||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death before Platelet recovery is competing risk.||The null hypothesis is that there is no difference between the platelet engraftment to 50k post-transplantation for dUCB vs. haplo-BM.||||0.146
71062668|NCT01597778|141633801|SUPERIORITY|||||||0.693||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death before 2nd graft failure is competing risk.||The null hypothesis is that there is no difference between the secondary graft failure probabilities post-transplantation for dUCB vs. haplo-BM.||||0.693
71062669|NCT01597778|141633802|SUPERIORITY|||||||0.142||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death prior to aGVHD is competing risk.||The null hypothesis is that there is no difference between the aGVHD grade II - IV probabilities post-transplantation for dUCB vs. haplo-BM.||||0.142
71062670|NCT01597778|141633802|SUPERIORITY|||||||0.604||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death prior to aGVHD is competing risk.||The null hypothesis is that there is no difference between the aGVHD grade III - IV probabilities post-transplantation for dUCB vs. haplo-BM.||||0.604
71062671|NCT01597778|141633803|SUPERIORITY|||||||0.361||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death before cGVHD is competing risk.||The null hypothesis is that there is no difference between the cGVHD probabilities post-transplantation for dUCB vs. haplo-BM.||||0.361
71062672|NCT01597778|141633804|SUPERIORITY|||||||0.0373||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Log Rank|||The null hypothesis is that there is no difference between the OS probabilities at year 2 post-randomization for dUCB vs. haplo-BM.||||0.0373
71062673|NCT01597778|141633804|SUPERIORITY|||||||0.0235||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Log Rank|||The null hypothesis is that there is no difference between the OS probabilities at year 2 post-transplant for dUCB vs. haplo-BM.||||0.0235
71062674|NCT01597778|141633805|SUPERIORITY|||||||0.039||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality across the two treatment groups.||The null hypothesis is that there is no difference between the TRM probabilities post-randomization for dUCB vs. haplo-BM.||||0.039
71062675|NCT01597778|141633805|SUPERIORITY|||||||0.03||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality across the two treatment groups.||The null hypothesis is that there is no difference between the TRM probabilities post-transplantation for dUCB vs. haplo-BM||||0.030
71062676|NCT01597778|141633806|SUPERIORITY|||||||0.968||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death prior to relapse is competing risk.||The null hypothesis is that there is no difference between the relapse/progression probabilities post-randomization for dUCB vs. haplo-BM.||||0.968
70852515|NCT04343235|141193737|SUPERIORITY|||||||0.77|||||||ANOVA|Main effect for randomization group||||||0.77
70852516|NCT04343235|141193738|SUPERIORITY|||||||0.54|||||||ANOVA|Main effect for randomization group||||||0.54
70852517|NCT04343235|141193739|SUPERIORITY||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|1.0||0.47|TWO_SIDED|95.0|-1.5|3.1|||t-test, 2 sided|||||3.1|-1.5|0.47
70852518|NCT04343235|141193740|SUPERIORITY|||||||0.57|||||||Fisher Exact|||||||0.57
70852519|NCT04343235|141193741|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
70852520|NCT00865280|141193742|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|-2.0|||||TWO_SIDED|95.0|-12.4|8.5|||||The 95% confidence interval (CI) was based on a normal approximation to the binomial distribution with continuity correction. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||8.5|-12.4|
70852521|NCT00865280|141193743|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|-3.6|||||TWO_SIDED|95.0|-15.5|8.3|||||The 95% CI was based on a normal approximation to the binomial distribution with continuity correction. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||8.3|-15.5|
70937066|NCT01853384|141374013|SUPERIORITY_OR_OTHER|||||||0.5348||||||Week 12 - Primary Endpoint|Cochran-Mantel-Haenszel|||||||0.5348
70937067|NCT01853384|141374015|SUPERIORITY_OR_OTHER|||||||0.5909||||||Week 01|ANCOVA|||||||0.5909
71062677|NCT01597778|141633806|SUPERIORITY|||||||0.907||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death prior to relapse is competing risk.||The null hypothesis is that there is no difference between the relapse/progression probabilities post- transplantation for dUCB vs. haplo-BM.||||0.907
71062678|NCT01597778|141633809|SUPERIORITY|||||||0.0003||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference between the total duration of hospitalization within 6 months post-randomization for dUCB vs. haplo-BM.||||0.0003
71062679|NCT04740918|141633855|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (estrogen receptors (ER) and/or progesterone receptor (PgR) positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the Hazard Ratio (HR).|Hazard Ratio (HR)|0.75||||0.2876|TWO_SIDED|95.0|0.44|1.28|||Log Rank|||||1.28|0.44|0.2876
71062680|NCT04740918|141633856|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the HR.|Hazard Ratio (HR)|1.59||||0.5151|TWO_SIDED|95.0|0.39|6.43|||Log Rank|||||6.43|0.39|0.5151
71062681|NCT04740918|141633857|SUPERIORITY|A Cochran-Mantel-Haenszel chi-square test, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis), was used to test for difference in response rates.|Odds Ratio (OR)|1.16||||0.724|TWO_SIDED|95.0|0.5|2.7|||Cochran-Mantel-Haenszel|||||2.70|0.50|0.7240
71062682|NCT04740918|141633858|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the HR.|Hazard Ratio (HR)|0.65||||0.3531|TWO_SIDED|95.0|0.26|1.61|||Log Rank|||||1.61|0.26|0.3531
70937068|NCT01853384|141374015|SUPERIORITY_OR_OTHER|||||||0.8234||||||Week 02|ANCOVA|||||||0.8234
71062683|NCT04740918|141633859|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the HR.|Hazard Ratio (HR)|1.35||||0.7175|TWO_SIDED|95.0|0.27|6.81|||Log Rank|||||6.81|0.27|0.7175
71062684|NCT04740918|141633860|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the HR.||||||0.3173|||||||Log Rank|||||||0.3173
71062685|NCT04740918|141633861|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the HR.|Hazard Ratio (HR)|1.19||||0.8658|TWO_SIDED|95.0|0.16|8.6|||Log Rank|||||8.60|0.16|0.8658
71062686|NCT04740918|141633862|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the HR.|Hazard Ratio (HR)|1.16||||0.8407|TWO_SIDED|95.0|0.27|4.99|||Log Rank|||||4.99|0.27|0.8407
71062687|NCT02524847|141633872|OTHER||Overall response rate (%)|55.2|||<|0.001|TWO_SIDED|95.0|35.7|73.6|||t-test, 2 sided|2-sided p-value for testing the null hypothesis H0: Standard therapy has a CR+PR rate = 10% after 4 weeks, using the exact Binomial test.||||73.6|35.7|<.001
71062688|NCT01709500|141633886|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.4|||<|0.0001|TWO_SIDED|95.0|-58.1|-44.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Alirocumab group was compared to the placebo group using an appropriate contrast statement.||-44.8|-58.1|<0.0001
71062689|NCT01709500|141633887|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.2|||<|0.0001|TWO_SIDED|95.0|-58.7|-45.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 5% level.||-45.6|-58.7|<0.0001
71062690|NCT01709500|141633888|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.4|||<|0.0001|TWO_SIDED|95.0|-54.7|-42.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-42.2|-54.7|<0.0001
71062691|NCT01709500|141633889|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.8|||<|0.0001|TWO_SIDED|95.0|-55.0|-42.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-42.5|-55|<0.0001
71062692|NCT01709500|141633890|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.3|||<|0.0001|TWO_SIDED|95.0|-44.1|-34.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-34.5|-44.1|<0.0001
71062693|NCT01709500|141633891|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.8|||<|0.0001|TWO_SIDED|95.0|-44.5|-35.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-35.1|-44.5|<0.0001
71062694|NCT01709500|141633892|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.7|||<|0.0001|TWO_SIDED|95.0|-51.8|-39.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-39.7|-51.8|<0.0001
71062695|NCT01709500|141633893|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.4|||<|0.0001|TWO_SIDED|95.0|-52.3|-40.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-40.4|-52.3|<0.0001
71062696|NCT01709500|141633894|SUPERIORITY_OR_OTHER||LS Mean difference|-32.8|||<|0.0001|TWO_SIDED|95.0|-37.4|-28.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-28.1|-37.4|<0.0001
71062697|NCT01709500|141633895|SUPERIORITY_OR_OTHER||LS Mean Difference|-34.5|||<|0.0001|TWO_SIDED|95.0|-39.2|-29.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-29.8|-39.2|<0.0001
71062698|NCT01709500|141633896|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.0|||<|0.0001|TWO_SIDED|95.0|-47.8|-36.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-36.2|-47.8|<0.0001
71062699|NCT01709500|141633897|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.9|||<|0.0001|TWO_SIDED|95.0|-34.5|-25.4|||Mixed Models Analysis|Threshold for significance ≤ 0.05.||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-25.4|-34.5|<0.0001
71062700|NCT01709500|141633898|SUPERIORITY_OR_OTHER||LS Mean Difference|-58.8|||<|0.0001|TWO_SIDED|95.0|-66.8|-50.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-50.8|-66.8|<0.0001
71062701|NCT01709500|141633899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|52.2|||<|0.0001|TWO_SIDED|95.0|20.9|130.0||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||130|20.9|<0.0001
71062702|NCT01709500|141633900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|53.3|||<|0.0001|TWO_SIDED|95.0|21.4|132.6||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||132.6|21.4|<0.0001
71110585|NCT00444925|141726841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.7395|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.7395
71110586|NCT00444925|141726841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
71110587|NCT00444925|141726841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0007|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||0.0007
71110588|NCT00444925|141726841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4185|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.4185
71110589|NCT00444925|141726841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
71110590|NCT00444925|141726841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0005|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||0.0005
71110591|NCT00444925|141726841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3798|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.3798
71110592|NCT00444925|141726842|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||0.0001
71110593|NCT00444925|141726842|SUPERIORITY_OR_OTHER|||||||0.0002||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||0.0002
70852522|NCT00865280|141193744|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|7.7|||||TWO_SIDED|95.0|-11.2|26.6|||||The 95% CI was based on a normal approximation to the binomial distribution with continuity correction. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||26.6|-11.2|
70852523|NCT00865280|141193745|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|-0.3|||||TWO_SIDED|95.0|-8.3|7.6|||||The 95% CI was based on a normal approximation to the binomial distribution with continuity correction. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||7.6|-8.3|
70852524|NCT00865280|141193746|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|7.7|||||TWO_SIDED|95.0|-11.2|26.6|||||The 95% CI was based on a normal approximation to the binomial distribution with continuity correction. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||26.6|-11.2|
70852525|NCT00865280|141193747|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|-0.3|||||TWO_SIDED|95.0|-8.3|7.6|||||The 95% CI was based on a normal approximation to the binomial distribution with continuity correction. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||7.6|-8.3|
70937069|NCT01853384|141374015|SUPERIORITY_OR_OTHER|||||||0.1556||||||Week 03|ANCOVA|||||||0.1556
70937070|NCT01853384|141374015|SUPERIORITY_OR_OTHER|||||||0.3487||||||Week 04|ANCOVA|||||||0.3487
70937071|NCT01853384|141374015|SUPERIORITY_OR_OTHER|||||||0.1064||||||Week 05|ANCOVA|||||||0.1064
71062703|NCT01709500|141633901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|239.7|||<|0.0001|TWO_SIDED|95.0|31.6|1820.3||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||1820.3|31.6|<0.0001
71062704|NCT01709500|141633902|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|240.6|||<|0.0001|TWO_SIDED|95.0|31.4|1841.7||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||1841.7|31.4|<0.0001
71062705|NCT01709500|141633903|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-20.3|||<|0.0001|TWO_SIDED|95.0|-26.4|-14.2||Threshold for significance ≤ 0.05.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-14.2|-26.4|<0.0001
71062706|NCT01709500|141633904|SUPERIORITY_OR_OTHER||LS Mean Difference|6.8|||=|0.0009|TWO_SIDED|95.0|2.8|10.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||10.7|2.8|= 0.0009
71062707|NCT01709500|141633905|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-10.9|||=|0.0012|TWO_SIDED|95.0|-17.5|-4.3||Threshold for significance ≤ 0.05.|Regression, Robust|||Testing according to the hierarchical testing procedure. Statistical analysis used a multiple imputation approach followed by a robust regression model.||-4.3|-17.5|= 0.0012
71062708|NCT01709500|141633906|SUPERIORITY_OR_OTHER||LS Mean Difference|4.4|||=|0.0062|TWO_SIDED|95.0|1.3|7.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||7.5|1.3|= 0.0062
70852526|NCT01616693|141193749|SUPERIORITY||Difference in seroconversion proportion|4.4|||||TWO_SIDED|97.5|-4.4|13.2||||||||13.2|-4.4|
70852527|NCT01616693|141193749|SUPERIORITY||Difference in seroconversion proportion|7.5|||||TWO_SIDED|95.0|-1.4|16.2||||||||16.2|-1.4|
70852528|NCT01616693|141193749|SUPERIORITY||Difference in seroconversion proportion|12.0|||||TWO_SIDED|95.0|0.8|22.8||||||||22.8|.8|
71062709|NCT01709500|141633907|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-19.1|||<|0.0001|TWO_SIDED|95.0|-25.0|-13.1||Threshold for significance ≤ 0.05.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-13.1|-25|<0.0001
71062710|NCT01709500|141633908|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3|||=|0.0147|TWO_SIDED|95.0|0.9|7.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||7.8|0.9|= 0.0147
71062711|NCT01709500|141633909|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.6|||=|0.024|TWO_SIDED|95.0|-16.1|-1.1||Threshold for significance ≤ 0.05.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-1.1|-16.1|= 0.024
71062712|NCT01709500|141633910|SUPERIORITY_OR_OTHER||LS Mean Difference|2.3|||=|0.1475|TWO_SIDED|95.0|-0.8|5.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||5.5|-0.8|= 0.1475
70852529|NCT01616693|141193751|SUPERIORITY||Mean Difference (Net)|1.1|||||TWO_SIDED|95.0|-4.3|6.6||||||||6.6|-4.3|
70852530|NCT01616693|141193751|SUPERIORITY||Mean Difference (Net)|-3.1|||||TWO_SIDED|95.0|-8.6|2.3||||||||2.3|-8.6|
70852531|NCT01616693|141193751|SUPERIORITY||Mean Difference (Net)|-2.0|||||TWO_SIDED|95.0|-9.8|5.7||||||||5.7|-9.8|
70852532|NCT00743106|141193763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0||||0.15|TWO_SIDED|95.0|-31.0|9.0|||Wilcoxon (Mann-Whitney)||The mean decrease in GFR was an estimated 11% less for fenoldopam than for placebo (interim-adjusted 95% confidence interval 9% more, 31% less).|||9|-31|0.15
70852533|NCT00743106|141193764|SUPERIORITY||ratio of geometric mean|0.98||||0.78|TWO_SIDED|95.0|0.79|1.19|||Mixed Models Analysis|||We assessed the effect of fenoldopam on creatinine over time (immediately postoperatively and on PODs 1-4). A linear mixed effects model was used to assess the main effect of fenoldopam on the postoperative log-transformed (base 2) serum creatinine, adjusting for baseline serum creatinine.||1.19|0.79|0.78
70852534|NCT02874144|141193769|SUPERIORITY|intention-to-treat with participants analyzed according to a randomly assigned treatment group irrespective of compliance.|Slope|0.0|STANDARD_ERROR_OF_MEAN|0.0|<|0.05|TWO_SIDED|||||The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|Regression, Linear|||We used baseline scores to track change to follow-up scores and used a difference-in-differences (D-I-D) statistical approach to compare the change over time compare relative rate of change over time between scores within the treatment group (AZD1981 plus INCS) and within the to scores within the placebo group (INCS treatment only)..|For inflammatory mediator analyses, data were reported as mean (SEM) with statistical significance determined by Kruskal-Wallis test.|||<0.05
70852535|NCT02874144|141193769|SUPERIORITY|This was a superiority trial. We used repeated-measures linear regression using the mixed procedure to calculate means for each outcome by visits and treatment status. We used baseline scores to track change to follow-up scores and used a difference-in-differences (D-I-D) statistical approach to compare the change over time between scores within the treatment group (AZD1981 plus INCS) to scores within the placebo group (INCS treatment only).|Mean Difference (Final Values)|-20.0|||<|0.05|TWO_SIDED|||||No, the p-value was not adjusted for multiple comparisons.|repeated-measures linear regression|We used repeated-measures linear regression using the MIXED procedure to calculate means (SEMS) for each outcome by visits and treatment status.|Our study did not include at relative risk.|The trial design is a continuous outcome superiority trial with primary efficacy outcome measures of change in Total Polyp Score (TPS) comparing AZD to placebo arm from V1 to V5. Total polyp score is a standardized method for assessing nasal polyp size by endoscopy, based on a scale of 1-4 per side. Inclusion criterion for this study is a TPS of ≥4 with a maximum of 8 and a standard deviation ± 2. A clinically meaningful effect is considered to be a decrease in total polyp score of 1.5.||||<0.05
70852536|NCT02975557|141193795|OTHER|||||||1|||||||Fisher Exact|The type I error was adjusted by using the alpha spending function approach with O'Brien-Fleming type boundaries.||We evaluated if the categorical type of tolerability measure is different between control (Artificial Tears) and intervention (Brimonidine, including both 0.15% high and 0.075% low doses groups).||||1
71062713|NCT02387840|141633913|OTHER|This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different||||||0.0002|||||||Wilcoxon (Mann-Whitney)|||Comparison of T1 values||||0.0002
71062714|NCT02387840|141633913|OTHER|This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||Comparison of T2 values||||0.0003
71062715|NCT02387840|141633914|OTHER|This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different||||||0.081|||||||Wilcoxon (Mann-Whitney)|||Comparison of T1 values||||0.081
71062716|NCT02387840|141633914|OTHER|This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different||||||0.081|||||||Wilcoxon (Mann-Whitney)|||Comparison of T2 values||||0.081
71062717|NCT02387840|141633915|OTHER|This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Comparison of T1 values||||0.12
71062718|NCT02387840|141633915|OTHER|This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Comparison of T2 values||||0.14
71062719|NCT00908544|141633918|OTHER|Changes (within CHI group) in HIV DNA in PBMC from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at months 36.|Mean Difference (Final Values)|0.2||||0.98|TWO_SIDED|95.0|0.0|0.4|||t-test, 1 sided|||||0.4|0.0|0.98
71062720|NCT00908544|141633918|OTHER|Changes (within PHI group) in HIV DNA in PBMC from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at months 36.|Mean Difference (Final Values)|-1.4|||<|0.01|TWO_SIDED|95.0|-1.7|-1.1|||t-test, 1 sided|||||-1.1|-1.7|<0.01
71062721|NCT00908544|141633918|OTHER|Changes (within CHI group) in HIV DNA in PBMC from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at months 84.|Mean Difference (Final Values)|0.12||||0.93|TWO_SIDED|95.0|-0.1|0.3|||t-test, 1 sided|||||0.3|-0.1|0.93
71062722|NCT00908544|141633918|OTHER|Changes (within PHI group) in HIV DNA in PBMC from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at months 84.|Mean Difference (Final Values)|-1.3|||<|0.01|TWO_SIDED|95.0|-1.6|-1.0|||t-test, 1 sided|||||-1.0|-1.6|<0.01
71062723|NCT00908544|141633919|OTHER|Changes (within CHI Group) in HIV DNA in CD4+T cells from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at month 36.|Mean Difference (Final Values)|0.2||||0.99|TWO_SIDED|95.0|0.0|0.4|||t-test, 1 sided|||||0.4|0.0|0.99
71062724|NCT00908544|141633919|OTHER|Changes (within PHI Group) in HIV DNA in CD4+T cells from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at month 36.|Mean Difference (Final Values)|-1.7|||<|0.01|TWO_SIDED|95.0|-2.0|-1.5|||t-test, 1 sided|||||-1.5|-2.0|<0.01
71062725|NCT00908544|141633919|OTHER|Changes (within CHI Group) in HIV DNA in CD4+T cells from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at month 84.|Mean Difference (Final Values)|0.2||||0.97|TWO_SIDED|95.0|0.0|0.3|||t-test, 1 sided|||||0.3|-0.0|0.97
71062726|NCT00908544|141633919|OTHER|Changes (within PHI Group) in HIV DNA in CD4+T cells from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at month 84.|Mean Difference (Final Values)|-1.7|||<|0.01|TWO_SIDED|95.0|-2.0|-1.4|||t-test, 1 sided|||||-1.4|-2.0|<0.01
71062727|NCT03170544|141633938|OTHER||Mean|1.33|STANDARD_ERROR_OF_MEAN|0.326|||TWO_SIDED|95.0|0.63|2.04|||||Mean (SE) and 95% CI were based on a linear fixed effects model containing a fixed effect for treatment (MK1092 Doses, Glargine).||The primary hypothesis would be supported if the Bayesian posterior probability of the true mean of GIRmax of MK-1092 lying within 1.5 and 4.5 mg/kg/min exceeded the prespecified threshold of 70% (in Part 3).|2.04|0.63|
71062728|NCT03170544|141633938|OTHER||Mean|2.74|STANDARD_ERROR_OF_MEAN|0.326|||TWO_SIDED|95.0|2.03|3.44|||||Mean (SE) and 95% CI were based on a linear fixed effects model containing a fixed effect for treatment (MK1092 Doses, Glargine).||The primary hypothesis would be supported if the Bayesian posterior probability of the true mean of GIRmax of MK-1092 lying within 1.5 and 4.5 mg/kg/min exceeded the prespecified threshold of 70% (in Part 3).|3.44|2.03|
71062729|NCT03888469|141633968|NON_INFERIORITY|Non-inferiority margin = 0.05|Least Squares Mean Difference|0.0|||||ONE_SIDED|95.0||0.0|||Mixed effects repeated measures model|Mixed effects repeated measures model with terms for lens, period and sequence as fixed effects and subject as a random effect.|Difference = DDT2 - Moist|||0.00||
71062730|NCT03477006|141633972|SUPERIORITY|||||||0.91|||||||Chi-squared|||||||0.91
71062731|NCT03477006|141633973|SUPERIORITY|||||||0.23|||||||Chi-squared|||||||0.23
71062732|NCT03477006|141633974|SUPERIORITY|||||||0.76|||||||Chi-squared|||||||0.76
71062733|NCT02174627|141633975|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% confidence interval (CI) of the difference between roxadustat and placebo exceeded 0 g/dL.|LS Mean Difference|1.35|STANDARD_ERROR_OF_MEAN|0.041|<|0.001|TWO_SIDED|95.0|1.27|1.43|||ANCOVA|||Difference between groups (roxadustat minus placebo) in LS mean changes; MAR-based multiple imputation ANCOVA model.||1.43|1.27|<0.001
71062734|NCT02174627|141633976|SUPERIORITY||Relative Risk|9.12|||<|0.001|TWO_SIDED|95.0|7.63|10.89|||Cochran-Mantel-Haenszel|||Comparison of the percentage of responders for roxadustat versus placebo was analysed using a Cochran-Mantel-Haenszel test adjusting for baseline Hb, baseline eGFR, geographic region and CV history.||10.89|7.63|<0.001
71062735|NCT02174627|141633977|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0 g/dL.|LS Mean Difference|1.13|STANDARD_ERROR_OF_MEAN|0.112|<|0.001|TWO_SIDED|95.0|0.91|1.35|||ANCOVA|||Difference between groups (roxadustat minus placebo) in LS mean changes; MAR-based multiple imputation ANCOVA model.||1.35|0.91|<0.001
71062736|NCT02174627|141633978|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0.|LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.013|<|0.001|TWO_SIDED|95.0|0.47|0.52|||ANCOVA|||Difference between groups (roxadustat minus placebo) in LS mean changes; ANCOVA model.||0.52|0.47|<0.001
71110594|NCT00444925|141726842|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
70937072|NCT01853384|141374015|SUPERIORITY_OR_OTHER|||||||0.2888||||||Week 06|ANCOVA|||||||0.2888
70937073|NCT01853384|141374015|SUPERIORITY_OR_OTHER|||||||0.6095||||||Week 07|ANCOVA|||||||0.6095
70937074|NCT01853384|141374015|SUPERIORITY_OR_OTHER|||||||0.1566||||||Week 08|ANCOVA|||||||0.1566
70937075|NCT01853384|141374015|SUPERIORITY_OR_OTHER|||||||0.4216||||||Week 09|ANCOVA|||||||0.4216
71062737|NCT02174627|141633979|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0.|LS Mean Difference|0.42|STANDARD_ERROR_OF_MEAN|0.013|<|0.001|TWO_SIDED|95.0|0.4|0.45|||ANCOVA|||Difference between groups (roxadustat minus placebo) in LS mean changes; ANCOVA model.||0.45|0.40|<0.001
71062738|NCT02174627|141633980|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0.|LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.033|<|0.001|TWO_SIDED|95.0|-0.42|-0.29|||ANCOVA|||Difference between groups (roxadustat minus placebo) in LS mean changes; ANCOVA model.||-0.29|-0.42|<0.001
71110595|NCT00444925|141726842|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
70852537|NCT01711216|141193819|SUPERIORITY_OR_OTHER|||||||0.3181|TWO_SIDED|||||Test statistic (d.f.) 1.0157 (1) A Mantel-Haenszel chi-square test was used, exact p-value was computed using Monte Carlo estimation.|Mantel Haenszel|||Test of association between the number of regular menstrual cycles during the follow-up period and the number of dydrogesterone therapy cycles received during the treatment period (Follow-up Analysis Set) Follow-up Analysis Set (N=915)||||0.3181
70937076|NCT01853384|141374015|SUPERIORITY_OR_OTHER|||||||0.8166||||||Week10|ANCOVA|||||||0.8166
70937077|NCT01853384|141374015|SUPERIORITY_OR_OTHER|||||||0.9114||||||Week 11|ANCOVA|||||||0.9114
70937078|NCT01853384|141374015|SUPERIORITY_OR_OTHER|||||||0.9733||||||Week 12|ANCOVA|||||||0.9733
70937079|NCT01853384|141374016|SUPERIORITY_OR_OTHER|||||||0.7439||||||Week 01|ANCOVA|||||||0.7439
70937080|NCT01853384|141374016|SUPERIORITY_OR_OTHER|||||||0.6992||||||Week 02|ANCOVA|||||||0.6992
70937081|NCT01853384|141374016|SUPERIORITY_OR_OTHER|||||||0.0867||||||Week 03|ANCOVA|||||||0.0867
70937082|NCT01853384|141374016|SUPERIORITY_OR_OTHER|||||||0.5739||||||Week 04|ANCOVA|||||||0.5739
70937083|NCT01853384|141374016|SUPERIORITY_OR_OTHER|||||||0.6497||||||Week 05|ANCOVA|||||||0.6497
70937084|NCT01853384|141374016|SUPERIORITY_OR_OTHER|||||||0.1427||||||Week 06|ANCOVA|||||||0.1427
71062739|NCT02174627|141633981|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the upper limit of the 2-sided 95% CI for the HR was ≤1.0.|Hazard Ratio (HR)|0.26|||<|0.001|TWO_SIDED|95.0|0.23|0.31|||Regression, Cox|||Treatments were compared using a Cox proportional hazards model, with baseline Hb and baseline eGFR as continuous variables used as covariates, and treatment group, CV history and geographic region as fixed effects. The Efron method was used for ties and p-values were calculated using the Wald test.||0.31|0.23|<0.001
70937085|NCT01853384|141374016|SUPERIORITY_OR_OTHER|||||||0.0682||||||Week 07|ANCOVA|||||||0.0682
70937086|NCT01853384|141374016|SUPERIORITY_OR_OTHER|||||||0.0161||||||Week 08|ANCOVA|||||||0.0161
70937087|NCT01853384|141374016|SUPERIORITY_OR_OTHER|||||||0.0973||||||Week 09|ANCOVA|||||||0.0973
70937088|NCT01853384|141374016|SUPERIORITY_OR_OTHER|||||||0.4661||||||Week 10|ANCOVA|||||||0.4661
70937089|NCT01853384|141374016|SUPERIORITY_OR_OTHER|||||||0.601||||||Week 11|ANCOVA|||||||0.6010
70937090|NCT01853384|141374016|SUPERIORITY_OR_OTHER|||||||0.3369||||||Week 12|ANCOVA|||||||0.3369
70937091|NCT01205126|141374022|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was demonstrated if upper bound of the 2-sided 95% CI was less than the non-inferiority margin of 1.5.|Least square mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.6||0.855|TWO_SIDED|95.0|-1.3|1.1||P-value was calculated by ANCOVA model using Baseline as covariate for change at Day 29.|ANCOVA|||||1.1|-1.3|0.855
70937092|NCT01205126|141374023|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was demonstrated if upper bound of the 2-sided 95% CI was less than the non-inferiority margin of 1.5.|Least square mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.39||0.615|TWO_SIDED|95.0|-1.0|0.6|||ANCOVA|P-value was calculated by ANCOVA model using Baseline as covariate for change at Day 29.||||0.6|-1.0|0.615
71062740|NCT02174627|141633982|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the upper limit of the 2-sided 95% CI for the HR was ≤1.0.|Hazard Ratio (HR)|0.37|||<|0.001|TWO_SIDED|95.0|0.3|0.44|||Regression, Cox|||Treatments were compared using a Cox proportional hazards model, with baseline Hb and baseline eGFR as continuous variables used as covariates, and treatment group, CV history and geographic region as fixed effects. The Efron method was used for ties and p-values were calculated using the Wald test.||0.44|0.30|<0.001
71062741|NCT02174627|141633983|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0.|LS Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.283||0.12|TWO_SIDED|95.0|-0.11|0.99|||Mixed Models Analysis|||Difference between groups (roxadustat minus placebo) in LS mean changes; MMRM analysis.||0.99|-0.11|0.120
71062742|NCT02174627|141633984|OTHER||Rate of Change Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.254||0.046|TWO_SIDED|95.0|-1.0|-0.01||Nominal p-value (as prior sequential outcome measure p-value did not meet \< 0.05.|Random Effects Analysis|||Difference between groups (roxadustat minus placebo) in rate of change in eGFR; random effects analysis.||-0.01|-1.00|0.046
71110596|NCT00444925|141726842|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.||||<0.0001
71110597|NCT00444925|141726842|SUPERIORITY_OR_OTHER|||||||0.0003||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.||||0.0003
71110598|NCT00444925|141726843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.273|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||0.2730
71110599|NCT00444925|141726843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.0652|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||0.0652
70852538|NCT03698591|141193843|OTHER||F-statistic|6.155||||0.019|TWO_SIDED|||||P-value corresponds to 3 way interaction. A priori significance threshold of p \< .05.|ANOVA|||The null hypothesis was that distancing performance would not differ by arm of the study. Within-subjects factors included task condition (distancing vs. distraction) and study arm. Study arm order was used as a between-subjects factor.||||.019
70852539|NCT03698591|141193843|OTHER||F-statistic|5.911||||0.021|TWO_SIDED|||||P-value corresponds to two-way interaction. A priori significance threshold of p \< .05.|ANOVA|||This analysis evaluated the two-way interaction of task condition and study period. The null hypothesis was that distancing performance would not differ by study period. Within-subjects factors included task condition and study period.||||.021
70937093|NCT01205126|141374024|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was demonstrated if upper bound of the 2-sided 95% CI was less than the non-inferiority margin of 1.5.|Least square mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.44||0.621|TWO_SIDED|95.0|-1.1|0.7|||ANCOVA|P-value was calculated by ANCOVA model using Baseline as covariate for change at Day 29.||||0.7|-1.1|0.621
71062743|NCT02174627|141633985|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0.|LS Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.269||0.051|TWO_SIDED|95.0|0.0|1.05||Nominal p-value (as prior sequential outcome measure p-value did not meet \< 0.05.|Mixed Models Analysis|||Difference between groups (roxadustat minus placebo) in LS mean changes; MMRM analysis.||1.05|0.00|0.051
71062744|NCT00071110|141633987|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||Statistic (t): -1.00|t-test, 2 sided|||||||0.32
71062745|NCT00071110|141633988|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||Statistic (t): 1.56|t-test, 2 sided|||||||0.09
71062746|NCT00071110|141633989|SUPERIORITY_OR_OTHER|||||||0.17||95.0||||Statistic (t): 1.40|t-test, 2 sided|||||||0.17
71062747|NCT03578367|141634017|OTHER|No test performed|Risk Difference (RD)|19.5|||||TWO_SIDED|90.0|5.0|33.1||||||||33.1|5.0|
71062748|NCT03578367|141634017|OTHER|No test performed|Risk Difference (RD)|28.57|||||TWO_SIDED|90.0|12.4|44.8||||||||44.8|12.4|
71062749|NCT03578367|141634018|OTHER|No test performed|Risk Difference (RD)|14.29|||||TWO_SIDED|90.0|-1.7|30.3||||||||30.3|-1.7|
71062750|NCT03578367|141634018|OTHER|No test performed|Risk Difference (RD)|23.81|||||TWO_SIDED|90.0|5.9|41.7||||||||41.7|5.9|
71062751|NCT01267019|141634036|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||This is a statistical analysis to determine the training effect of social cognitive skills training (in vivo and social cog versus control).||||< .05
71062752|NCT01267019|141634037|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
71062753|NCT01267019|141634038|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
71110600|NCT00444925|141726843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.3503|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.3503
70852540|NCT03698591|141193843|OTHER||t-statistic|-1.656||||0.108|TWO_SIDED|||||A priori significance threshold of p \< .05.|t-test, 2 sided|||A dependent-samples t-test was used to compare distancing performance between study periods 1 and 2. The null hypothesis was that distancing performance would not differ by study period.||||.108
70852541|NCT03698591|141193843|OTHER||F-statistic|0.004||||0.948|TWO_SIDED|||||A priori threshold of p \< .05. This value reflects the test of the main effect of study arm.|ANOVA|||For this analysis, study arm and task condition were used as within-subjects factors, study arm order was used as a between-subjects factor, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.||||.948
70852542|NCT03698591|141193844|OTHER||F-statistic|0.031||||0.862|TWO_SIDED|||||P-value corresponds to the two way interaction of task condition and study arm . A priori significance threshold of p \< .05.|ANOVA|||The null hypothesis was that distancing self-reported effort would not differ by arm of the study. Within-subjects factors included task condition (distancing vs. distraction) and study arm. Study arm order was used as a between-subjects factor.||||.862
70852543|NCT03698591|141193844|OTHER||F-statistic|4.04||||0.054|TWO_SIDED|||||P-value corresponds to the main effect of study period. A priori threshold of p \< .05.|ANOVA|||A follow-up ANOVA was run with within-subjects factors of task condition and study period.||||.054
70937094|NCT01205126|141374025|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was demonstrated if upper bound of the 2-sided 95% CI was less than the non-inferiority margin of 1.5.||||||0.832|||||||ANCOVA|P-value was calculated by ANCOVA model using Baseline as covariate for change at Day 29.||||||0.832
71062754|NCT02729025|141634039|SUPERIORITY||LS Mean Treatment Difference|-3.0|STANDARD_ERROR_OF_MEAN|2.24||0.18|TWO_SIDED|95.0|-7.4|1.39|||Multivariate regression model||Treatment difference used placebo as the reference|A multivariate regression was modelled on the primary endpoint as well as three other response variables (percent change in Lp\[a\] at Weeks 8 and 16, baseline MDS TBR, and baseline Lp\[a\]). The primary endpoint was regressed on the treatment group and statin stratification factor; baseline MDS TBR and Lp(a) were regressed on the statin stratification factor, and percent changes in Lp(a) were regressed on the treatment group, statin stratification factor, visit, and treatment group by visit.||1.39|-7.40|0.18
71062755|NCT02729025|141634040|SUPERIORITY||LS Mean Treatment Difference|-13.89|STANDARD_ERROR_OF_MEAN|2.73|<|0.0001|TWO_SIDED|95.0|-19.29|-8.49|||Repeated measures linear effects model|The model included treatment group, statin stratification, scheduled visit, and the interaction of treatment with scheduled visit.|Treatment difference used placebo as the reference|||-8.49|-19.29|<0.0001
71062756|NCT02729025|141634041|SUPERIORITY||LS Mean Treatment Difference|-60.66|STANDARD_ERROR_OF_MEAN|2.6|<|0.0001|TWO_SIDED|95.0|-65.81|-55.51|||Repeated measures linear effects model|The model included treatment group, statin stratification, scheduled visit, and the interaction of treatment with scheduled visit.|Treatment difference used placebo as the reference|||-55.51|-65.81|<0.0001
71062757|NCT02729025|141634042|SUPERIORITY||LS Mean Treatment Difference|-51.29|STANDARD_ERROR_OF_MEAN|2.15|<|0.0001|TWO_SIDED|95.0|-55.85|-47.33|||Repeated measures linear effects model|The model included treatment group, statin stratification, scheduled visit, and the interaction of treatment with scheduled visit.|Treatment difference used placebo as the reference|||-47.33|-55.85|<0.0001
71062758|NCT03504397|141634118|SUPERIORITY||Hazard Ratio (HR)|0.734||||0.0024|TWO_SIDED|95.0|0.591|0.91||"Log-rank test stratified by:~* Region (Asia vs Non-Asia)~* Number of organs with metastatic sites (0 to 2 vs ≥ 3)~* Prior gastrectomy (Yes or No)"|Log Rank|||||0.910|0.591|0.0024
71062759|NCT03504397|141634119|SUPERIORITY||Hazard Ratio (HR)|0.784||||0.0075|TWO_SIDED|95.0|0.644|0.954||"Log-rank test stratified by:~* Region (Asia vs Non-Asia)~* Number of organs with metastatic sites (0 to 2 vs ≥ 3)~* Prior gastrectomy (Yes or No)"|Log Rank|||||0.954|0.644|0.0075
71062760|NCT03504397|141634120|SUPERIORITY||Hazard Ratio (HR)|1.295||||0.028|TWO_SIDED|95.0|0.994|1.687||"Log-rank test stratified by:~* Region (Asia vs Non-Asia)~* Number of organs with metastatic sites (0 to 2 vs ≥ 3)~* Prior gastrectomy (Yes or No)"|Log Rank|||||1.687|0.994|0.0280
71062761|NCT03504397|141634121|SUPERIORITY||Hazard Ratio (HR)|0.713||||0.0508|TWO_SIDED|95.0|0.475|1.071||"Log-rank test stratified by:~* Region (Asia vs Non-Asia)~* Number of organs with metastatic sites (0 to 2 vs ≥ 3)~* Prior gastrectomy (Yes or No)"|Log Rank|||||1.071|0.475|0.0508
71062762|NCT03504397|141634122|SUPERIORITY||Hazard Ratio (HR)|1.142||||0.1685|TWO_SIDED|95.0|0.874|1.492|||Log Rank||"Log-rank test stratified by:~* Region (Asia vs Non-Asia)~* Number of organs with metastatic sites (0 to 2 vs ≥ 3)~* Prior gastrectomy (Yes or No)"|||1.492|0.874|0.1685
71110601|NCT00444925|141726843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.2667|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||0.2667
71110602|NCT00444925|141726843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1643|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||0.1643
71110603|NCT00444925|141726843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.7264|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.7264
71110604|NCT00444925|141726843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3269|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||0.3269
71110605|NCT00444925|141726843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.5059|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||0.5059
71062763|NCT03504397|141634123|SUPERIORITY|||||||0.4536|||||||Cochran-Mantel-Haenszel|Based on 1-sided Cochran-Mantel-Haenszel (CMH) test. Stratification factors were Region, Number of Metastatic Sites and Prior Gastrectomy.||||||0.4536
71062764|NCT03504397|141634124|SUPERIORITY||Hazard Ratio (HR)|0.789||||0.0721|TWO_SIDED|95.0|0.573|1.087|||Log Rank||"Log-rank test stratified by:~* Region (Asia vs Non-Asia)~* Number of organs with metastatic sites (0 to 2 vs ≥ 3)~* Prior gastrectomy (Yes or No)"|||1.087|0.573|0.0721
71062765|NCT03190993|141634133|OTHER|Linear mixed effect models were used to test if changes (Day 28 - Baseline) were equal between treatment groups (primary outcome).|Mean Difference (Net)|0.56|STANDARD_ERROR_OF_MEAN|0.43|=|0.22|TWO_SIDED||||||Regression, Linear|||||||=0.22
71062766|NCT03588910|141634153|SUPERIORITY|Wilcoxon rank-sum tests||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||.87
71062767|NCT03588910|141634154|SUPERIORITY|Wilcoxon rank-sum tests||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||.36
71062768|NCT03588910|141634155|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||.91
71062769|NCT03588910|141634156|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||.29
71062770|NCT03588910|141634157|SUPERIORITY|||||||0.36|||||||Chi-squared|||||||.36
71062771|NCT00611923|141634158|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.57|||||||t-test, 2 sided|||paired t-test analysis comparing change from baseline PMTS score at month 1 between flutamide and placebo groups||||= 0.57
71062772|NCT00611923|141634158|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.27|||||||t-test, 2 sided|||paired t-test analysis comparing change from baseline PMTS score at month 2 between flutamide and placebo groups.||||= .27
71062773|NCT00611923|141634159|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.52|||||||t-test, 2 sided|||paired t-test comparing change in DRSP scores from baseline to Month 1 of treatment Larger positive change score indicates a greater reduction in symptoms from baseline.||||= 0.52
71062774|NCT00611923|141634159|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.2|||||||t-test, 2 sided|||paired t-test comparing change in DRSP scores from baseline to Month 2 of treatment Larger positive change score indicates a greater reduction in symptoms from baseline.||||= 0.2
71062775|NCT00611923|141634160|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.8|||||||t-test, 2 sided|||||||= 0.8
71062776|NCT00611923|141634160|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.1|||||||t-test, 2 sided|||||||= 0.1
71062777|NCT00611923|141634161|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.15|||||||t-test, 2 sided|||paired t-test was performed comparing the Clinical Global Improvement score at month 1 between placebo and flutamide groups||||=.15
71062778|NCT00611923|141634161|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.05|||||||t-test, 2 sided|||t-test was performed comparing the Clinical Global Improvement score at month 2 between placebo and flutamide groups||||= .05
71062779|NCT00611923|141634162|SUPERIORITY_OR_OTHER_LEGACY|Comparison of change from baseline score to treatment month 1 between placebo and flutamide treated subjects.|||||=|0.5|||||||t-test, 2 sided|||||||=0.5
71062780|NCT00611923|141634162|SUPERIORITY_OR_OTHER_LEGACY|paired t-test analysis comparing change from baseline CGI severity score at month 2 between flutamide and placebo groups|||||<|0.04|||||||t-test, 2 sided|||||||<.04
71062781|NCT00611923|141634163|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.2|||||||t-test, 2 sided|||paired t-test was performed comparing the Patient Global Improvement score at month 1 between placebo and flutamide groups||||=0.2
71062782|NCT00611923|141634163|SUPERIORITY_OR_OTHER_LEGACY|paired t-test was performed comparing the Patient Globall Improvement score at treatment month 2 between placebo and flutamide groups|||||=|0.06|||||||t-test, 2 sided|||||||=0.06
71062783|NCT03380429|141634204|SUPERIORITY||Mean Difference (Final Values)|12.0|||<|0.001|TWO_SIDED|95.0|5.2|18.8||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||18.8|5.2|<0.001
71062784|NCT03380429|141634205|OTHER||Mean Difference (Final Values)|8.2||||0.016|TWO_SIDED|95.0|1.6|14.9||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||14.9|1.6|0.016
71062785|NCT03380429|141634205|OTHER||Mean Difference (Final Values)|9.3||||0.006|TWO_SIDED|95.0|2.7|16.0||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||16.0|2.7|0.006
71062786|NCT03380429|141634205|OTHER||Mean Difference (Final Values)|8.1||||0.018|TWO_SIDED|95.0|1.4|14.8||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||14.8|1.4|0.018
71062787|NCT03380429|141634206|OTHER||Mean Difference (Final Values)|9.3||||0.003|TWO_SIDED|95.0|3.2|15.3||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||15.3|3.2|0.003
71062788|NCT03380429|141634206|OTHER||Mean Difference (Final Values)|7.7||||0.011|TWO_SIDED|95.0|1.8|13.7||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||13.7|1.8|0.011
71062789|NCT03380429|141634206|OTHER||Mean Difference (Final Values)|5.5||||0.066|TWO_SIDED|95.0|-0.4|11.4||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||11.4|-0.4|0.066
71062790|NCT03380429|141634206|OTHER||Mean Difference (Final Values)|2.8||||0.359|TWO_SIDED|95.0|-3.1|8.7||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||8.7|-3.1|0.359
71062791|NCT03380429|141634207|OTHER||Mean Difference (Final Values)|9.7||||0.004|TWO_SIDED|95.0|3.1|16.3||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||16.3|3.1|0.004
71062792|NCT03380429|141634207|OTHER||Mean Difference (Final Values)|7.1||||0.032|TWO_SIDED|95.0|0.6|13.5||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||13.5|0.6|0.032
71062793|NCT03380429|141634207|OTHER||Mean Difference (Final Values)|5.9||||0.07|TWO_SIDED|95.0|-0.5|12.4||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||12.4|-0.5|0.070
70852544|NCT03698591|141193844|OTHER||t-statistic|2.694||||0.012|TWO_SIDED|||||A priori significance threshold of p \< .05.|t-test, 2 sided|||A follow-up dependent-samples t-test was run to test a potential effect of study period on distancing effort.||||.012
71062794|NCT03380429|141634207|OTHER||Mean Difference (Final Values)|3.4||||0.294|TWO_SIDED|95.0|-3.0|9.9||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||9.9|-3.0|0.294
71062795|NCT03380429|141634208|OTHER||Mean Difference (Final Values)|4.8||||0.118|TWO_SIDED|95.0|-1.2|10.8||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline rescue use, duration of run-in (visits), country, gender and age.|||10.8|-1.2|0.118
71062796|NCT03380429|141634208|OTHER||Mean Difference (Final Values)|4.8||||0.105|TWO_SIDED|95.0|-1.0|10.7||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline rescue use, duration of run-in (visits), country, gender and age.|||10.7|-1.0|0.105
71062797|NCT03380429|141634208|OTHER||Mean Difference (Final Values)|9.2||||0.002|TWO_SIDED|95.0|3.3|15.1||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline rescue use, duration of run-in (visits), country, gender and age.|||15.1|3.3|0.002
71062798|NCT03380429|141634208|OTHER||Mean Difference (Final Values)|7.3||||0.015|TWO_SIDED|95.0|1.5|13.2||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline rescue use, duration of run-in (visits), country, gender and age.|||13.2|1.5|0.015
71062799|NCT03380429|141634210|OTHER||Mean Difference (Net)|-0.5||||0.4|TWO_SIDED|95.0|-1.6|0.6||p-value was calculated using Mixed Model Repeated Measures (MMRM).|MMRM||Analysis was performed by MMRM adjusted for randomized treatment arm,Baseline ACT total score,randomized treatment arm-by-visit interaction,Baseline ACT total score-by-visit interaction,gender,age,country and participant fitted as a random factor.|||0.6|-1.6|0.400
71062800|NCT03380429|141634210|OTHER||Mean Difference (Net)|0.4||||0.441|TWO_SIDED|95.0|-0.7|1.5||p-value was calculated using MMRM.|MMRM||Analysis was performed by MMRM adjusted for randomized treatment arm,Baseline ACT total score,randomized treatment arm-by-visit interaction,Baseline ACT total score-by-visit interaction,gender,age,country and participant fitted as a random factor.|||1.5|-0.7|0.441
71062801|NCT03380429|141634210|OTHER||Mean Difference (Net)|0.8||||0.164|TWO_SIDED|95.0|-0.3|1.9||p-value was calculated using MMRM.|MMRM||Analysis was performed by MMRM adjusted for randomized treatment arm,Baseline ACT total score,randomized treatment arm-by-visit interaction,Baseline ACT total score-by-visit interaction,gender,age,country and participant fitted as a random factor.|||1.9|-0.3|0.164
71062802|NCT03380429|141634210|OTHER||Mean Difference (Net)|0.3||||0.661|TWO_SIDED|95.0|-0.9|1.4||p-value was calculated using MMRM.|MMRM||Analysis was performed by MMRM adjusted for randomized treatment arm,Baseline ACT total score,randomized treatment arm-by-visit interaction,Baseline ACT total score-by-visit interaction,gender,age,country and participant fitted as a random factor.|||1.4|-0.9|0.661
71062803|NCT03380429|141634211|OTHER||Odds Ratio (OR)|0.75||||0.385|TWO_SIDED|95.0|0.39|1.44||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.44|0.39|0.385
71062804|NCT03380429|141634211|OTHER||Odds Ratio (OR)|1.24||||0.517|TWO_SIDED|95.0|0.64|2.42||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||2.42|0.64|0.517
71062805|NCT03380429|141634211|OTHER||Odds Ratio (OR)|0.97||||0.921|TWO_SIDED|95.0|0.51|1.85||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.85|0.51|0.921
71062806|NCT03380429|141634211|OTHER||Odds Ratio (OR)|0.72||||0.321|TWO_SIDED|95.0|0.38|1.38||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.38|0.38|0.321
71062807|NCT03380429|141634212|OTHER||Odds Ratio (OR)|1.04||||0.911|TWO_SIDED|95.0|0.54|1.98||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.98|0.54|0.911
71062808|NCT03380429|141634212|OTHER||Odds Ratio (OR)|1.33||||0.383|TWO_SIDED|95.0|0.7|2.54||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||2.54|0.70|0.383
71062809|NCT03380429|141634212|OTHER||Odds Ratio (OR)|1.08||||0.814|TWO_SIDED|95.0|0.57|2.04||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||2.04|0.57|0.814
71062810|NCT03380429|141634212|OTHER||Odds Ratio (OR)|1.01||||0.986|TWO_SIDED|95.0|0.53|1.89||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.89|0.53|0.986
71062811|NCT03380429|141634213|OTHER||Odds Ratio (OR)|0.93||||0.833|TWO_SIDED|95.0|0.48|1.81||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.81|0.48|0.833
71062812|NCT03380429|141634213|OTHER||Odds Ratio (OR)|1.35||||0.383|TWO_SIDED|95.0|0.69|2.67||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||2.67|0.69|0.383
70937095|NCT01205126|141374026|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was demonstrated if upper bound of the 2-sided 95% CI was less than the non-inferiority margin of 1.5.||||||0.304|||||||ANCOVA|P-value was calculated by ANCOVA model using Baseline as covariate for change at Day 29||||||0.304
70937096|NCT01205126|141374027|SUPERIORITY_OR_OTHER|||||||0.276|||||||rank sum test, 2 sided|||||||0.276
70937097|NCT03331978|141374028|SUPERIORITY||Mean Difference (Net)|6.89|STANDARD_ERROR_OF_MEAN|3.91||0.08|TWO_SIDED|95.0|-0.82|14.61|||Regression, Linear|Model is adjusted for participant sex, which was found to be significantly associated with adherence in a similar repeated measures model.|Values entered are for regression coefficient for intervention indicator (versus control) and represents the adjusted difference across all follow-up time points.|Tested with repeated measures linear regression where all 6 past-month post-intervention measurements of adherence were stacked together such that each participant could contribute up to 6 records. Standard errors were adjusted for clustering on participant, and weights for presence of data were used. Fixed effects were an intervention indicator and continuous adherence measured at baseline. Model included all participants with adherence data (a) at baseline and (b) at least one follow-up month.||14.61|-0.82|.08
70937098|NCT03331978|141374029|SUPERIORITY||Odds Ratio (OR)|1.98||||0.0257|TWO_SIDED|95.0|1.09|3.6||Per above, p-value is from repeated measures logistic regression with standard errors adjusted for clustering on participant.|Regression, Logistic||Odds ratio is for intervention indicator (versus controls).|Tested with repeated measures logistic regression where all 6 past-month post-intervention measurements of adherence were stacked together such that each participant could contribute up to 6 records. Standard errors were adjusted for clustering on participant, and weights for presence of data were used. Fixed effects were an intervention indicator and baseline dichotomous adherence. Model included all participants with adherence data (a) at baseline and (b) at least one follow-up month.||3.60|1.09|.0257
70937099|NCT03331978|141374030|SUPERIORITY||Odds Ratio (OR)|1.82||||0.26|TWO_SIDED|95.0|0.64|5.18||As mentioned above, p-value comes from repeated measures regression with standard errors adjusted for clustering on participant.|Regression, Logistic||Odds ratio is for intervention indicator (versus controls).|Tested with repeated measures logistic regression where both post-intervention measurements were stacked together such that each participant could contribute up to 2 records. Standard errors were adjusted for clustering on participant, and weights for presence of viral suppression data were used. Fixed effects were an intervention indicator and baseline viral suppression. Model included all viral suppression data (a) at baseline and (b) close to either of the two follow-up surveys.||5.18|0.64|.26
70937100|NCT03331978|141374031|SUPERIORITY||Odds Ratio (OR)|0.57||||0.05|TWO_SIDED|95.0|0.32|1.0||As mentioned above, p-value is from repeated measures regression with standard errors adjusted for clustering on participant.|Regression, Logistic||Odds ratio is for intervention indicator (versus controls).|Tested with repeated measures logistic regression where both post-intervention responses were stacked together such that each participant could contribute up to 2 records. Standard errors were adjusted for clustering on participant, and weights for follow-up response were used. Fixed effects were an intervention indicator and baseline stigma. Model included all participants with responses (a) at baseline and (b) at least one of the two follow-up surveys.||1.00|0.32|.05
71062813|NCT03380429|141634213|OTHER||Odds Ratio (OR)|0.85||||0.628|TWO_SIDED|95.0|0.44|1.63||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.63|0.44|0.628
70941750|NCT04748445|141383935|OTHER||Slope|0.0002121|STANDARD_ERROR_OF_MEAN|6.877||0.7583|TWO_SIDED|90.0|-0.0009275|0.001352|||Mixed Models Analysis|||MM\_MFCC 1st order delta 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001352|-0.0009275|0.7583
71062814|NCT03380429|141634213|OTHER||Odds Ratio (OR)|0.94||||0.844|TWO_SIDED|95.0|0.49|1.8||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.80|0.49|0.844
71062815|NCT05691712|141634247|SUPERIORITY||LS Mean Difference|-16.1|||<|0.001|TWO_SIDED|95.0|-19.9|-12.36|||Mixed Models Analysis|||||-12.36|-19.9|<0.001
71062816|NCT05691712|141634247|SUPERIORITY||LS Mean Difference|-15.9|||<|0.001|TWO_SIDED|95.0|-19.7|-12.1|||Mixed Models Analysis|||||-12.10|-19.7|<0.001
71062817|NCT05691712|141634248|SUPERIORITY||LS Mean Difference|-13.06|||<|0.001|TWO_SIDED|95.0|-16.8|-9.34|||Mixed Models Analysis|||||-9.34|-16.8|<0.001
71062818|NCT05691712|141634249|SUPERIORITY||LS Mean Difference|-4.4|||<|0.001|TWO_SIDED|95.0|-5.8|-2.9|||Mixed Models Analysis|||||-2.9|-5.8|<0.001
71062819|NCT05691712|141634249|SUPERIORITY||LS Mean Difference|-6.5|||<|0.001|TWO_SIDED|95.0|-8.0|-5.0|||Mixed Models Analysis|||||-5.0|-8.0|<0.001
71062820|NCT05691712|141634249|SUPERIORITY||LS Mean Difference|-6.0|||<|0.001|TWO_SIDED|95.0|-7.5|-4.5|||Mixed Models Analysis|||||-4.5|-7.5|<0.001
71062821|NCT05691712|141634251|SUPERIORITY||LS Mean Difference|-21.9|||<|0.001|TWO_SIDED|95.0|-32.4|-11.3|||Mixed Models Analysis|||||-11.3|-32.4|<0.001
71062822|NCT05691712|141634251|SUPERIORITY||LS Mean Difference|-28.9|||<|0.001|TWO_SIDED|95.0|-39.6|-18.1|||Mixed Models Analysis|||||-18.1|-39.6|<0.001
71062823|NCT05691712|141634251|SUPERIORITY||LS Mean Difference|-27.3|||<|0.001|TWO_SIDED|95.0|-38.2|-16.5|||Mixed Models Analysis|||||-16.5|-38.2|<0.001
71062824|NCT00226499|141634263|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|94.943|||<|0.0001|TWO_SIDED|97.5|92.446|96.615|||Regression, Cox|||Vaccine Efficacy (VE) was measured by calculating the relative risk of a confirmed varicella case in a vaccine group compared to a confirmed varicella case in the control group.||96.615|92.446|<0.0001
71062825|NCT00226499|141634263|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|65.428||||0.1265|TWO_SIDED|97.5|57.182|72.086|||Regression, Cox|||Vaccine Efficacy (VE) was measured by calculating the relative risk of a confirmed varicella case in a vaccine group compared to a confirmed varicella case in the control group.||72.086|57.182|0.1265
70937101|NCT03331978|141374032|SUPERIORITY||Mean Difference (Net)|-0.215|STANDARD_ERROR_OF_MEAN|0.091||0.0199|TWO_SIDED|95.0|-0.395|-0.034||As described above, p-value is from repeated measures regression with standard errors adjusted for clustering on participant|Regression, Linear||Estimation parameter is the regression coefficient for intervention indicator (vs. control) and represents the adjusted difference across both follow-up time points.|Tested with repeated measures linear regression where both post-intervention responses were stacked together such that each participant could contribute up to 2 records. Standard errors were adjusted for clustering on participant, and weights for follow-up response were used. Fixed effects were an intervention indicator and baseline stigma. Model included all participants with responses (a) at baseline and (b) at least one of the two follow-up surveys.||-0.034|-0.395|.0199
70937102|NCT00687297|141374044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||1||95.0|||||Fisher Exact|||Fisher's exact test with two-sided Type I error of 5% was used to test the null hypothesis of no difference in response rate between arms.||||1.00
71062826|NCT00226499|141634264|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|99.498||||0.0001|TWO_SIDED|95.0|97.522|99.898|||Regression, Cox|||VE was measured by calculating the relative risk of a moderate or severe confirmed varicella case in a vaccine group compared to a moderate or severe confirmed varicella case in the control group.||99.898|97.522|0.0001
71062827|NCT00226499|141634264|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|90.741||||0.1265|TWO_SIDED|95.0|85.866|93.934|||Regression, Cox|||VE was measured by calculating the relative risk of a moderate or severe confirmed varicella case in a vaccine group compared to a moderate or severe confirmed varicella case in the control group.||93.934|85.866|0.1265
71062828|NCT00226499|141634265|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|92.487|||<|0.0001|TWO_SIDED|95.0|89.927|94.396|||Regression, Cox|||VE was measured by calculating the relative risk of a probable or confirmed varicella case in a vaccine group compared to a probable or confirmed varicella case in the control group.||94.396|89.927|<0.0001
71062829|NCT00226499|141634265|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|64.585||||0.1265|TWO_SIDED|95.0|57.503|70.486|||Regression, Cox|||VE was measured by calculating the relative risk of a probable or confirmed varicella case in a vaccine group compared to a probable or confirmed varicella case in the control group.||70.486|57.503|0.1265
71062830|NCT00226499|141634285|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|95.855|||<|0.0001|TWO_SIDED|95.0|94.075|97.101|||Regression, Cox|||VE was measured by calculating the relative risk of a confirmed varicella case in a vaccine group compared to a confirmed varicella case in the control group.||97.101|94.075|<0.0001
71062831|NCT00226499|141634285|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|69.812||||0.1265|TWO_SIDED|95.0|62.848|75.47|||Regression, Cox|||VE was measured by calculating the relative risk of a confirmed varicella case in a vaccine group compared to a confirmed varicella case in the control group.||75.470|62.848|0.1265
71062832|NCT00226499|141634286|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|99.072|||<|0.0001|TWO_SIDED|95.0|97.907|99.589|||Regression, Cox|||VE was measured by calculating the relative risk of a moderate or severe confirmed varicella case in a vaccine group compared to a moderate or severe confirmed varicella case in the control group.||99.589|97.907|<0.0001
71062833|NCT00226499|141634286|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|89.532||||0.1265|TWO_SIDED|95.0|86.126|92.102|||Regression, Cox|||VE was measured by calculating the relative risk of a moderate or severe confirmed varicella case in a vaccine group compared to a moderate or severe confirmed varicella case in the control group.||92.102|86.126|0.1265
71062834|NCT00226499|141634287|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|94.816|||<|0.0001|TWO_SIDED|95.0|92.838|96.248|||Regression, Cox|||VE was measured by calculating the relative risk of a probable or confirmed varicella case in a vaccine group compared to a probable or confirmed varicella case in the control group.||96.248|92.838|<0.0001
71062835|NCT00226499|141634287|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|68.932||||0.1265|TWO_SIDED|95.0|61.893|74.671|||Regression, Cox|||VE was measured by calculating the relative risk of a probable or confirmed varicella case in a vaccine group compared to a probable or confirmed varicella case in the control group.||74.671|61.893|0.1265
71062836|NCT00946920|141634301|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between treatments (degarelix versus goserelin acetate) was chosen to be -5 percentage points.|Kaplan-Meier estimate|79.6|||||TWO_SIDED|95.0|75.6|83.7||||||The cumulative probability of testosterone ≤0.5 ng/mL from Day 3 to Day 364 was estimated by the Kaplan-Meier method. Only testosterone measurements taken at scheduled trial visits from Day 3 to Day 364 were included in the analysis. The hypothesis to test was the following: a non-inferiority assessment determined whether degarelix was non-inferior to goserelin with respect to the cumulative probability of testosterone ≤0.5 ng/mL from Day 3 to Day 364.||83.7|75.6|
71110606|NCT00444925|141726843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.699|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.6990
70937103|NCT00687297|141374045|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49||||0.02|TWO_SIDED|95.0|1.07|2.07||p-value from Wald test|Regression, Cox|The model was adjusted for gender (male vs. female) and stage (Stage IIIB vs. Stage IV/Recurrent)||There was 80% power to detect a 50% improvement in median progression-free survival, using a stratified log-rank test with one-sided Type I error of 10%.||2.07|1.07|0.02
71062837|NCT01268527|141634319|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|711.4||||0.0038|TWO_SIDED|95.0|292.5|1130.3|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, Least Squares Means (LSM), and Confidence Intervals (CI) were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||1130.3|292.5|0.0038
71062838|NCT01268527|141634319|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|1119.8|||<|0.0001|TWO_SIDED|95.0|858.9|1380.6|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||1380.6|858.9|<0.0001
71062839|NCT01268527|141634319|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|780.0||||0.0523|TWO_SIDED|95.0|-8.5|1568.5|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||1568.5|-8.5|0.0523
71062840|NCT01268527|141634319|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|1775.1|||<|0.0001|TWO_SIDED|95.0|1392.3|2158.0|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||2158.0|1392.3|<0.0001
71062841|NCT01268527|141634319|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|921.4||||0.0002|TWO_SIDED|95.0|515.7|1327.1|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||1327.1|515.7|0.0002
71062842|NCT01268527|141634319|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|937.8||||0.0115|TWO_SIDED|95.0|267.6|1607.9|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||1607.9|267.6|0.0115
71062843|NCT01268527|141634320|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|101.5||||0.0042|TWO_SIDED|95.0|36.0|167.0|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||167.0|36.0|0.0042
71062844|NCT01268527|141634320|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|182.4|||<|0.0001|TWO_SIDED|95.0|140.3|224.4|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||224.4|140.3|<0.0001
71062845|NCT01268527|141634320|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|169.5|||<|0.0001|TWO_SIDED|95.0|127.4|211.5|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||211.5|127.4|<0.0001
71062846|NCT01268527|141634320|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|246.6|||<|0.0001|TWO_SIDED|95.0|185.0|308.1|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||308.1|185.0|<0.0001
71062847|NCT01268527|141634320|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|132.3||||0.0043|TWO_SIDED|95.0|53.9|210.7|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||210.7|53.9|0.0043
71062848|NCT01268527|141634320|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|145.0||||0.0036|TWO_SIDED|95.0|64.2|225.8|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM) and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||225.8|64.2|0.0036
71062849|NCT01268527|141634321|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|80.7||||0.0013|TWO_SIDED|95.0|34.6|126.7|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||126.7|34.6|0.0013
71062850|NCT01268527|141634321|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|127.9|||<|0.0001|TWO_SIDED|95.0|92.4|163.5|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||163.5|92.4|<0.0001
71062851|NCT01268527|141634321|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|110.2||||0.0458|TWO_SIDED|95.0|2.4|218.0|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||218.0|2.4|0.0458
71062852|NCT01268527|141634321|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|207.5|||<|0.0001|TWO_SIDED|95.0|155.2|259.9|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||259.9|155.2|<0.0001
70937104|NCT01584648|141374049|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.59|0.91|||||Hazard ratios (HRs) were estimated using a Pike estimator.|||0.91|0.59|
70937105|NCT01584648|141374050|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.64|1.02|||||Hazard ratios (HRs) were estimated using a Pike estimator.|||1.02|0.64|
70937106|NCT01328756|141374068|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Change from baseline to LOTA value was assessed for differences from zero using a 2-sided, 1 sample t-test at a 0.05 significance level.||||< 0.001
70937107|NCT00244751|141374079|SUPERIORITY_OR_OTHER|||||||0.3608|||||||reduced regression model|||||||0.3608
70937108|NCT00244751|141374079|SUPERIORITY_OR_OTHER|||||||0.3575|||||||reduced regression model|||||||0.3575
70937109|NCT00244751|141374080|SUPERIORITY_OR_OTHER|||||||0.9157|||||||reduced regression model|||||||0.9157
70937110|NCT00244751|141374080|SUPERIORITY_OR_OTHER|||||||0.9501|||||||reduced regression model|||||||0.9501
70937111|NCT00244751|141374081|SUPERIORITY_OR_OTHER|||||||0.6483|||||||Cochran-Mantel-Haenszel Test|||Comparison for Ranked assessment (fibrosis)||||0.6483
70937112|NCT00244751|141374081|SUPERIORITY_OR_OTHER|||||||0.1776|||||||Cochran-Mantel-Haenszel Test|||Comparison for Ranked assessment (necrosis)||||0.1776
70937113|NCT02206607|141374107|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR1/IR|31.27|||||TWO_SIDED|90.0|28.09|34.8||||||||34.80|28.09|
70937114|NCT02206607|141374107|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR2/IR|25.56|||||TWO_SIDED|90.0|23.11|28.27||||||||28.27|23.11|
70937115|NCT02206607|141374107|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR3/IR|32.04|||||TWO_SIDED|90.0|28.93|35.49||||||||35.49|28.93|
71062853|NCT01268527|141634321|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|125.3||||0.0003|TWO_SIDED|95.0|71.5|179.0|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||179.0|71.5|0.0003
71062854|NCT01268527|141634321|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|128.6||||0.0029|TWO_SIDED|95.0|93.9|163.3|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||163.3|93.9|0.0029
70937116|NCT02206607|141374108|SUPERIORITY_OR_OTHER||Least Square Mean|15.72|STANDARD_ERROR_OF_MEAN|3.357||1|TWO_SIDED|80.0|11.39|20.06||1-sided p-value|Mixed Models Analysis|Treatment, period, sequence as fixed effects and subjects-within-sequence as random effects.||||20.06|11.39|1.0000
70937117|NCT02206607|141374108|SUPERIORITY_OR_OTHER||Least Square Mean|16.31|STANDARD_ERROR_OF_MEAN|3.399||1|TWO_SIDED|80.0|11.93|20.7||1-sided p-value|Mixed Models Analysis|Treatment, period, sequence as fixed effects and subjects-within-sequence as random effects.||||20.70|11.93|1.000
70937118|NCT02206607|141374108|SUPERIORITY_OR_OTHER||Least Square Mean|20.38|STANDARD_ERROR_OF_MEAN|3.291||1|TWO_SIDED|80.0|16.13|24.62||1-sided p-value|Mixed Models Analysis|||||24.62|16.13|1.0000
71078080|NCT01026818|141664582|SUPERIORITY_OR_OTHER||LS Mean Differences|4.55|STANDARD_ERROR_OF_MEAN|6.17||0.461|TWO_SIDED|95.0|-7.58|16.68||P-value is for Q2 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||16.68|-7.58|0.461
71078081|NCT01026818|141664582|SUPERIORITY_OR_OTHER||LS Mean Differences|-1.26|STANDARD_ERROR_OF_MEAN|6.05||0.835|TWO_SIDED|95.0|-13.16|10.63||P-value is for Q2 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||10.63|-13.16|0.835
71078082|NCT01026818|141664582|SUPERIORITY_OR_OTHER||LS Mean Differences|13.36|STANDARD_ERROR_OF_MEAN|6.15||0.03|TWO_SIDED|95.0|1.27|25.46||P-value is for Q2 - Month13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||25.46|1.27|0.030
71078083|NCT01026818|141664582|SUPERIORITY_OR_OTHER||LS Mean Differences|5.96|STANDARD_ERROR_OF_MEAN|6.07||0.326|TWO_SIDED|95.0|-5.97|17.89||P-value is for Q2 - Month13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||17.89|-5.97|0.326
70937119|NCT02206607|141374109|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR1/IR|25.21|||||TWO_SIDED|90.0|23.28|27.31||||||||27.31|23.28|
70937120|NCT02206607|141374109|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR2/IR|26.38|||||TWO_SIDED|90.0|24.36|28.57||||||||28.57|24.36|
70937121|NCT02206607|141374109|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR3/IR|36.94|||||TWO_SIDED|90.0|34.09|40.02||||||||40.02|34.09|
70937122|NCT02206607|141374115|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR1/IR|31.06|||||TWO_SIDED|90.0|28.28|34.1||||||||34.10|28.28|
70937123|NCT02206607|141374115|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR2/IR|24.96|||||TWO_SIDED|90.0|22.73|27.4||||||||27.40|22.73|
70937124|NCT02206607|141374115|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR3/IR|31.69|||||TWO_SIDED|90.0|28.86|34.81||||||||34.81|28.86|
70937125|NCT02516202|141374125|SUPERIORITY|||||||0.25||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||||||0.25
70937126|NCT02516202|141374125|SUPERIORITY|||||||0.31||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||||||0.31
71078084|NCT01026818|141664582|SUPERIORITY_OR_OTHER||LS Mean Differences|12.06|STANDARD_ERROR_OF_MEAN|5.13||0.019||95.0|1.98|22.15||P-value is for Q3 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||22.15|1.98|0.019
71062855|NCT01288079|141634325|SUPERIORITY_OR_OTHER||LS mean|-1.5|STANDARD_ERROR_OF_MEAN|2.95||0.617|TWO_SIDED|95.0|-7.35|4.39|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit treatment by visit interaction, region, responsiveness, and region by responsiveness are fixed effects in the model; pooled center is a random effect.||4.39|-7.35|0.617
71062856|NCT01288079|141634325|SUPERIORITY_OR_OTHER||LS mean|-3.6|STANDARD_ERROR_OF_MEAN|3.26||0.277|TWO_SIDED|95.0|-10.06|2.91|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness are fixed effects in the model; pooled center is a random effect.||2.91|-10.06|0.277
71062857|NCT01288079|141634325|SUPERIORITY_OR_OTHER||LS mean|-3.9|STANDARD_ERROR_OF_MEAN|2.95||0.194|TWO_SIDED|95.0|-9.72|2.0|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness are fixed effects in the model; pooled center is a random effect.||2.00|-9.72|0.194
71062858|NCT00503698|141634404|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.97||||0.91|TWO_SIDED|95.0|0.6|1.57|||Regression, Cox|Time to all-cause death analysed using stratified Cox regression model with treatment and sex as fixed factors, age and time in dialysis as covariates||||1.57|0.60|0.91
71062859|NCT00503698|141634405|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.4977|TWO_SIDED|95.0|0.6|1.28|||Regression, Cox|Time to all-cause death analysed using stratified Cox regression model with treatment and sex as fixed factors, age and time in dialysis as covariates||||1.28|0.60|0.4977
71062860|NCT00503698|141634406|SUPERIORITY_OR_OTHER||Rate ratio|1.13||||0.4409|TWO_SIDED|95.0|0.83|1.53|||Negative binomial regression|||||1.53|0.83|0.4409
71062861|NCT02259010|141634427|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Ratio|0.98|||||TWO_SIDED|90.0|0.82|1.19|||||Estimates were obtained using a mixed effects model of log (PK parameter) with fixed terms for the itraconazole effect and random terms for participant within period.|||1.19|0.82|
71110607|NCT00444925|141726845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0008|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||0.0008
71110608|NCT00444925|141726845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||<0.0001
71110609|NCT00444925|141726845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.382|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.3820
71110610|NCT00444925|141726845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
71110611|NCT00444925|141726845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||<0.0001
71110612|NCT00444925|141726845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3498|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.3498
71062862|NCT02259010|141634428|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Ratio|1.35|||||TWO_SIDED|90.0|1.02|1.79|||||Estimates were obtained using a mixed effects model of log (PK parameter) with fixed terms for the itraconazole effect and random terms for participant within period.|||1.79|1.02|
71062863|NCT02259010|141634429|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Ratio|1.39|||||TWO_SIDED|90.0|0.99|1.95|||||Estimates were obtained using a mixed effects model of log (PK parameter) with fixed terms for the itraconazole effect and random terms for participant within period.|||1.95|0.99|
71062864|NCT03830333|141634440|NON_INFERIORITY|Ceftolozane/tazobactam + metronidazole is concluded to be non-inferior to meropenem + placebo if the lower bound of the 95% CI for the treatment difference in percent response is above -12.5 percentage points.|Difference in percentages|2.1|||||TWO_SIDED|95.0|-4.7|8.8||||||Difference in percentage was based on Miettinen and Nurminen method with the Cochran-Mantel-Haenszel (CMH) weighting stratified by anatomic site of infection (bowel \[small or large\] versus other site of cIAI).||8.8|-4.7|
71062865|NCT03830333|141634441|OTHER||Difference in percentages|-4.4|||||TWO_SIDED|95.0|-12.6|3.7||||||Difference in percentage was based on Miettinen and Nurminen method with the CMH weighting stratified by anatomic site of infection (bowel \[small or large\] versus other site of cIAI).||3.7|-12.6|
71110613|NCT00444925|141726845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
70937127|NCT02516202|141374126|SUPERIORITY|||||||0.99||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||||||0.99
70937128|NCT02516202|141374126|SUPERIORITY|||||||0.05||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||||||0.05
70937129|NCT02516202|141374127|SUPERIORITY|||||||0.64||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||||||0.64
71062866|NCT03830333|141634442|OTHER||Difference in percentages|1.4|||||TWO_SIDED|95.0|-3.8|6.7||||||Difference in percentage was based on Miettinen and Nurminen method with the CMH weighting stratified by anatomic site of infection (bowel \[small or large\] versus other site of cIAI).||6.7|-3.8|
71062867|NCT03830333|141634443|OTHER||Difference in percentages|-1.5|||||TWO_SIDED|95.0|-8.0|4.8||||||Difference in percentage was based on Miettinen and Nurminen method with the CMH weighting stratified by anatomic site of infection (bowel \[small or large\] versus other site of cIAI).||4.8|-8.0|
71062868|NCT03830333|141634444|OTHER||Difference in percentages|1.2|||||TWO_SIDED|95.0|-9.2|10.4||||||Difference in percentage based on Miettinen and Nurminen method with the CMH weighting stratified by anatomic site of infection (bowel \[small or large\] versus other site of cIAI).||10.4|-9.2|
71062869|NCT03830333|141634445|OTHER|Difference in percentage was based on unstratified Miettinen and Nurminen method. Confidence Interval is displayed only when there are at least 4 participants in at least one treatment group.|Difference in percentages|-1.0|||||TWO_SIDED|95.0|-11.9|8.7||||||Gram-negative aerobes comparison: Based on unstratified Miettinen and Nurminen method.||8.7|-11.9|
71062870|NCT03830333|141634445|OTHER|Difference in percentage was based on unstratified Miettinen and Nurminen method. Confidence Interval is displayed only when there are at least 4 participants in at least one treatment group.|Difference in percentages|-1.2|||||TWO_SIDED|95.0|-12.5|8.5||||||All enterobacteriaceae comparison: Based on unstratified Miettinen and Nurminen method.||8.5|-12.5|
71062871|NCT03830333|141634445|OTHER|Difference in percentage was based on unstratified Miettinen and Nurminen method. Confidence Interval is displayed only when there are at least 4 participants in at least one treatment group.|Difference in percentages|-8.2|||||TWO_SIDED|95.0|-42.2|20.0||||||Gram-positive aerobes comparison: Based on unstratified Miettinen and Nurminen method.||20.0|-42.2|
71062872|NCT03830333|141634446|OTHER||Difference in Percentages|-0.7|||||TWO_SIDED|95.0|-12.6|11.2||||||Difference in percentage was based on Miettinen \& Nurminen method.||11.2|-12.6|
71062873|NCT03830333|141634447|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-4.4|4.4||||||Difference in percentage was based on Miettinen \& Nurminen method.||4.4|-4.4|
71062874|NCT02996227|141634466|NON_INFERIORITY|The noninferiority was defined as no more than 25% greater opioid consumption and no worse than 1-point higher pain score at rest. Non-inferiority of TAP with liposomal bupivacaine to epidural could be claimed if the upper limit of the 95.2% CI for the mean difference of pain scores at rest was less than 1 point and the CI for the ratio of geometric means in opioid consumption was less than 1.25.|Mean Difference (Final Values)|0.09|||<|0.001|TWO_SIDED|95.2|-0.12|0.3|||Mixed Models Analysis|||||0.30|-0.12|<0.001
71062875|NCT02996227|141634467|NON_INFERIORITY|The noninferiority was defined as no more than 25% greater opioid consumption and no worse than 1-point higher pain score at rest. Non-inferiority of TAP with liposomal bupivacaine to epidural could be claimed if the upper limit of the 95.2% CI for the mean difference of pain scores at rest was less than 1 point and the CI for the ratio of geometric means in opioid consumption was less than 1.25.|Ratio of Geometric means|1.37||||0.754|TWO_SIDED|95.2|1.05|1.79|||Mixed Models Analysis|||||1.79|1.05|0.754
71062876|NCT02996227|141634468|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.56|TWO_SIDED|99.0|0.53|2.76|||Regression, Linear|linear regression after logarithm transformation||||2.76|0.53|0.560
71062877|NCT02996227|141634469|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.357|TWO_SIDED|99.0|-0.65|1.37|||Regression, Linear||Difference in means between two groups was assessed using mixed effects model with repeated measurements with unstructured correlation structure|||1.37|-0.65|0.357
71062878|NCT02996227|141634470|SUPERIORITY||Risk Ratio (RR)|0.64||||0.006|TWO_SIDED|99.0|0.42|0.98|||generalized linear regression|||||0.98|0.42|0.006
71062879|NCT02996227|141634471|SUPERIORITY||Mean Difference (Final Values)|0.77||||0.695|TWO_SIDED|99.0|-4.31|5.85|||Regression, Linear||Difference in means between two groups was assessed using mixed effects model with repeated measurements with unstructured correlation structure.|||5.85|-4.31|0.695
71062880|NCT02996227|141634472|SUPERIORITY||Ratio of geometric means|0.98||||0.738|TWO_SIDED|99.0|0.86|1.12|||Regression, Linear|linear regression after logarithmic transformation||||1.12|0.86|0.738
71062881|NCT04242446|141634488|SUPERIORITY||Odds Ratio (OR)|2.0||||0.03|TWO_SIDED|97.5|0.979|4.089|||Regression, Logistic|||||4.089|0.979|0.030
71062882|NCT04242446|141634488|SUPERIORITY||Odds Ratio (OR)|2.234||||0.006|TWO_SIDED|97.5|1.159|4.307|||Regression, Logistic|||||4.307|1.159|0.006
71062883|NCT04242446|141634489|SUPERIORITY||Odds Ratio (OR)|1.416||||0.35|TWO_SIDED|97.5|0.615|3.26||Nominal p-value only due to the testing hierarchy failing on the HISCR50 outcome.|Regression, Logistic|||||3.260|0.615|0.350
71062884|NCT04242446|141634489|SUPERIORITY||Odds Ratio (OR)|2.175||||0.021|TWO_SIDED|97.5|1.021|4.635|||Regression, Logistic|||||4.635|1.021|0.021
71062885|NCT04242446|141634490|SUPERIORITY||LS mean difference|-2.574||||0.002|TWO_SIDED|97.5|-4.472|-0.675||Nominal p-value only due to the testing hierarchy failing on the HISCR50 outcome.|ANCOVA|||||-0.675|-4.472|0.002
71062886|NCT04242446|141634490|SUPERIORITY||LS mean difference|-2.682|||<|0.001|TWO_SIDED|97.5|-4.394|-0.97|||ANCOVA|||||-0.970|-4.394|<0.001
71062887|NCT04242446|141634491|SUPERIORITY||LS mean difference|-0.551||||0.201|TWO_SIDED|97.5|-1.521|0.418||Nominal p-value only due to the testing hierarchy failing on the HISCR50 outcome.|ANCOVA|||||0.418|-1.521|0.201
71062888|NCT04242446|141634491|SUPERIORITY||LS mean difference|-1.186||||0.002|TWO_SIDED|97.5|-2.05|-0.322|||ANCOVA|||||-0.322|-2.050|0.002
71062889|NCT04242446|141634492|SUPERIORITY||Odds Ratio (OR)|1.618||||0.367|TWO_SIDED|97.5|0.489|5.352||Nominal p-value only due to the testing hierarchy failing on the HISCR50 outcome.|Regression, Logistic|||||5.352|0.489|0.367
71062890|NCT04242446|141634492|SUPERIORITY||Odds Ratio (OR)|2.757||||0.041|TWO_SIDED|97.5|0.909|8.364|||Regression, Logistic|||||8.364|0.909|0.041
71062891|NCT03349060|141634533|SUPERIORITY||Difference in Percentage|15.8||||0.0037|TWO_SIDED|95.0|6.8|24.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and confidence interval (CI) for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||24.8|6.8|0.0037
71062892|NCT03349060|141634533|SUPERIORITY||Difference in Percentage|36.0|||<|0.0001|TWO_SIDED|95.0|26.2|45.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||45.7|26.2|<0.0001
71062893|NCT03349060|141634534|SUPERIORITY||Difference in Percentage|27.9|||<|0.0001|TWO_SIDED|95.0|17.4|38.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.3|17.4|<0.0001
71062894|NCT03349060|141634534|SUPERIORITY||Difference in Percentage|51.0|||<|0.0001|TWO_SIDED|95.0|40.5|61.5|||Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||61.5|40.5|<0.0001
71110614|NCT00444925|141726845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||<0.0001
71110615|NCT00444925|141726845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0542|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.0542
71110616|NCT00444925|141726846|SUPERIORITY_OR_OTHER|||||||0.0004||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||0.0004
71110617|NCT00444925|141726846|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||0.0001
71110618|NCT00444925|141726846|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
71110619|NCT00444925|141726846|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
71062895|NCT03349060|141634535|SUPERIORITY||Difference in Percentage|18.0||||0.0004|TWO_SIDED|95.0|10.2|25.8|||Cochran-Mantel-Haenszel|||Week 2: Each complete imputed data set was analyzed using the Cochran-Mantel-Haenszel (CMH) risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||25.8|10.2|0.0004
71062896|NCT03349060|141634535|SUPERIORITY||Difference in Percentage|42.5|||<|0.0001|TWO_SIDED|95.0|33.6|51.4|||Cochran-Mantel-Haenszel|||Week 2: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||51.4|33.6|<0.0001
71062897|NCT03349060|141634535|SUPERIORITY||Difference in Percentage|15.0||||0.0251|TWO_SIDED|95.0|1.9|28.0|||Cochran-Mantel-Haenszel|||Week 4: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||28.0|1.9|0.0251
70937130|NCT02516202|141374127|SUPERIORITY|||||||0.17||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||||||0.17
70937131|NCT02516202|141374129|SUPERIORITY|||||||0.02||||||p-value calculation includes 195 participants with known responses at week 12.|Chi-squared|||||||0.02
70937132|NCT02516202|141374130|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
70937133|NCT02516202|141374130|SUPERIORITY|||||||0.6|||||||Chi-squared|||||||0.60
71062898|NCT03349060|141634535|SUPERIORITY||Difference in Percentage|41.1|||<|0.0001|TWO_SIDED|95.0|27.8|54.4|||Cochran-Mantel-Haenszel|||Week 4: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||54.4|27.8|<0.0001
71062899|NCT03349060|141634535|SUPERIORITY||Difference in Percentage|20.0||||0.0019|TWO_SIDED|95.0|7.4|32.7|||Cochran-Mantel-Haenszel|||Week 8: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||32.7|7.4|0.0019
71062900|NCT03349060|141634535|SUPERIORITY||Difference in Percentage|45.3|||<|0.0001|TWO_SIDED|95.0|32.7|57.8|||Cochran-Mantel-Haenszel|||Week 8: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||57.8|32.7|<0.0001
71062901|NCT03349060|141634535|SUPERIORITY||Difference in Percentage|22.5||||0.0003|TWO_SIDED|95.0|10.3|34.8|||Cochran-Mantel-Haenszel|||Week 12: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||34.8|10.3|0.0003
71062902|NCT03349060|141634535|SUPERIORITY||Difference in Percentage|41.7|||<|0.0001|TWO_SIDED|95.0|29.6|53.9|||Cochran-Mantel-Haenszel|||Week 12: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||53.9|29.6|<0.0001
70937134|NCT02516202|141374131|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
70937135|NCT02516202|141374131|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
71110620|NCT00444925|141726846|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.||||<0.0001
71110621|NCT00444925|141726846|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.||||0.0001
70937136|NCT00337610|141374132|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.02|STANDARD_DEVIATION|1.19|<|0.001||95.0|-1.36|-0.67|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic agent (AHA) \[medication\] (on Monotherapy AHA or on Metformin-based combination therapy)||||-0.67|-1.36|<0.001
70937137|NCT00337610|141374133|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-25.5|STANDARD_DEVIATION|42.2|<|0.001||95.0|-37.7|-13.3|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic medication (on Monotherapy AHA or on Metformin-based combination therapy)||||-13.3|-37.7|<0.001
70937138|NCT00337610|141374134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-54.1|STANDARD_DEVIATION|63.8|<|0.001||95.0|-74.7|-33.6|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic medication (on Monotherapy AHA or on Metformin-based combination therapy)||||-33.6|-74.7|<0.001
70937139|NCT00337610|141374135|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.01|STANDARD_DEVIATION|1.34|<|0.001||95.0|-1.4|-0.62|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic medication (on Monotherapy AHA or on Metformin-based combination therapy)||||-0.62|-1.40|<0.001
70937140|NCT04012970|141374146|SUPERIORITY||||||<|0.05|||||||ANOVA|2-way, repeated measures||||||<0.05
70937141|NCT04012970|141374146|SUPERIORITY||||||<|0.01|||||||ANCOVA|||Stiffness change ran with covariates (baseline stiffness, BMI, ODI, waist circumference, height and gender).||||<0.01
70937142|NCT04012970|141374147|SUPERIORITY||||||<|0.01|||||||ANOVA|2-way, repeated measures||||||<0.01
70937143|NCT04012970|141374147|SUPERIORITY||||||<|0.01|||||||ANCOVA|||Stiffness change ran with covariates (baseline stiffness, BMI, ODI, waist circumference, height and gender).||||<0.01
70937144|NCT04012970|141374148|SUPERIORITY||||||<|0.01|||||||ANOVA|2-way, repeated measures||||||<0.01
70937145|NCT04012970|141374148|SUPERIORITY||||||<|0.05|||||||ANCOVA|||Tone change ran with covariates (baseline stiffness, BMI, ODI, waist circumference, height and gender).||||<0.05
71110622|NCT00444925|141726847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||<0.0001
71110623|NCT00444925|141726847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||<0.0001
71110624|NCT00444925|141726847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.5581|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.5581
71110625|NCT00444925|141726847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
71110626|NCT00444925|141726847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||<0.0001
71110627|NCT00444925|141726847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.151|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.1510
71110628|NCT00444925|141726847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
71110629|NCT00444925|141726847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.2||0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||0.0001
71110630|NCT00444925|141726847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1391|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.1391
71110631|NCT00444925|141726848|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||<0.0001
71110632|NCT00444925|141726848|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||<0.0001
71110633|NCT00444925|141726848|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
71110634|NCT00444925|141726848|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
71110635|NCT00444925|141726848|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.||||<0.0001
70937146|NCT04012970|141374149|SUPERIORITY||||||<|0.01|||||||ANOVA|2-way, repeated measures||||||<0.01
71110636|NCT00444925|141726848|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.||||0.0001
70937147|NCT04012970|141374149|SUPERIORITY||||||<|0.05|||||||ANCOVA|||Tone change ran with covariates (baseline stiffness, BMI, ODI, waist circumference, height and gender).||||<0.05
71110637|NCT00444925|141726849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||<0.0001
71110638|NCT00444925|141726849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||<0.0001
71110639|NCT00444925|141726849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.5972|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.5972
71110640|NCT00444925|141726849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
70937148|NCT04012970|141374150|SUPERIORITY||||||<|0.01|||||||ANOVA|2-way, repeated measures||||||<0.01
70937149|NCT04012970|141374151|SUPERIORITY||||||<|0.001|||||||ANOVA|2-way, repeated measures||||||<0.001
70937150|NCT03205488|141374152|SUPERIORITY|||||||0.3626|||||||Fisher Exact|One-sided Fisher's Exact tested the proportion of participants who met tolerability between the Nilotinib 150 group to the Placebo group.||||||0.3626
70937151|NCT03205488|141374152|SUPERIORITY|||||||0.3895|||||||Fisher Exact|One-sided Fisher's Exact tested the proportion of participants who met tolerability between the Nilotinib 300 group to the Placebo group.||||||0.3895
70937152|NCT03205488|141374153|EQUIVALENCE|H0 : p1 = p2, where p represents the proportion of SAEs for each group. HA : p1 ≠ p2||||||1|||||||Fisher Exact|Fisher's Exact test compared a proportion of participants who experienced any serious adverse event in the Nilotinib 150 group and the Placebo group.||||||1.00
70937153|NCT03205488|141374153|EQUIVALENCE|H0 : λ1 = λ2, where λ represents the rate of SAEs for each group. HA : λ1 ≠ λ2|Risk Ratio (RR)|0.4977||||0.5689|TWO_SIDED|95.0|0.0451|5.489|||Regression, Poisson|Rates of serious adverse event between the Nilotinib 150 group and the placebo were also compared using a Poisson regression model||||5.489|0.0451|0.5689
71110641|NCT00444925|141726849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||<0.0001
71110642|NCT00444925|141726849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.1267|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.1267
71110643|NCT00444925|141726849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
71110644|NCT00444925|141726849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||<0.0001
71110645|NCT00444925|141726849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.0289|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.0289
71110646|NCT00444925|141726850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||<0.0001
70937154|NCT03205488|141374153|EQUIVALENCE|H0 : p1 = p3, where p represents the proportion of SAEs for each group. HA : p1 ≠ p3||||||0.61|||||||Fisher Exact|Fisher's Exact test compared a proportion of participants who experienced any serious adverse event in the Nilotinib 300 group and the Placebo group.||||||0.61
71062903|NCT03349060|141634536|SUPERIORITY||Difference in Percentage|16.3||||0.0055|TWO_SIDED|95.0|7.4|25.2|||Cochran-Mantel-Haenszel|||Week 2: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||25.2|7.4|0.0055
70852545|NCT03698591|141193844|OTHER||F-statistic|3.196||||0.085|TWO_SIDED|||||A priori threshold of p \< .05. This value reflects the test of the main effect of study arm.|ANOVA|||Post-hoc analyses were used to explore treatment effects using covariates related to the treatment parameters. For this analysis, study arm and task condition were used as within-subjects factors, study arm order was used as a between-subjects factor, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.||||.085
70852546|NCT03698591|141193844|OTHER||F-statistic|7.162||||0.013|TWO_SIDED|||||A priori threshold of p \< .05. This value reflects the test of the main effect of study arm.|ANOVA|||This analysis examined the effect of study arm specifically on distancing effort. The within-subjects factor was study arm, between-subjects factor was study arm order, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.||||.013
70852547|NCT03698591|141193845|OTHER||F-statistic|6.155||||0.019|TWO_SIDED|||||P-value corresponds to 3 way interaction. A priori significance threshold of p \< .05.|ANOVA|||The null hypothesis was that distraction performance would not differ by arm of the study. Within-subjects factors included task condition (distancing vs. distraction) and study arm. Study arm order was used as a between-subjects factor.||||.019
70852548|NCT03698591|141193845|OTHER||F-statistic|5.911||||0.021|TWO_SIDED|||||P-value corresponds to two-way interaction. A priori significance threshold of p \< .05.|ANOVA|||This analysis evaluated the two-way interaction of task condition and study period. The null hypothesis was that distraction performance would not differ by study period. Within-subjects factors included task condition and study period.||||.021
70852549|NCT03698591|141193845|OTHER||t-statistic|1.282||||0.21|TWO_SIDED|||||A priori significance threshold of p \< .05.|t-test, 2 sided|||A dependent-samples t-test was used to compare distraction performance between study periods 1 and 2. The null hypothesis was that distraction performance would not differ by study period.||||.210
70852550|NCT03698591|141193845|OTHER||F-statistic|0.004||||0.948|TWO_SIDED|||||A priori threshold of p \< .05. This value reflects the test of the main effect of study arm.|ANOVA|||Post-hoc analyses were used to explore treatment effects using covariates related to the treatment parameters. For this analysis, study arm and task condition were used as within-subjects factors, study arm order was used as a between-subjects factor, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.||||.948
70852551|NCT03698591|141193846|OTHER||F-statistic|0.031||||0.862|TWO_SIDED|||||P-value corresponds to the two way interaction of task condition and study arm . A priori significance threshold of p \< .05.|ANOVA|||The null hypothesis was that distraction self-reported effort would not differ by arm of the study. Within-subjects factors included task condition (distancing vs. distraction) and study arm. Study arm order was used as a between-subjects factor.||||.862
70852552|NCT03698591|141193846|OTHER||F-statistic|4.04||||0.054|TWO_SIDED|||||P-value corresponds to the main effect of study period. A priori threshold of p \< .05.|ANOVA|||A follow-up ANOVA was run with within-subjects factors of task condition and study period.||||.054
70852553|NCT03698591|141193846|OTHER||t-statistic|0.828||||0.415|TWO_SIDED|||||A priori significance threshold of p \< .05.|t-test, 2 sided|||A follow-up dependent-samples t-test was run to test the effect of study period on distraction effort.||||.415
70852554|NCT03698591|141193846|OTHER||F-statistic|3.196||||0.085|TWO_SIDED|||||A priori threshold of p \< .05. This value reflects the test of the main effect of study arm.|ANOVA|||Post-hoc analyses were used to explore treatment effects using covariates related to the treatment parameters. For this analysis, study arm and task condition were used as within-subjects factors, study arm order was used as a between-subjects factor, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.||||.085
70852555|NCT03698591|141193846|OTHER||F-statistic|0.396||||0.535|TWO_SIDED|||||A priori threshold of p \< .05. This value reflects the test of the main effect of study arm.|ANOVA|||This analysis examined the effect of study arm specifically on distraction performance. The within-subjects factor was study arm, between-subjects factor was study arm order, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.||||.535
70937155|NCT03205488|141374153|EQUIVALENCE|H0 : λ1 = λ3, where λ represents the rate of SAEs for each group. HA : λ1 ≠ λ3|Risk Ratio (RR)|0.5206||||0.594|TWO_SIDED|95.0|0.0472|5.7409|||Regression, Poisson|Rates of serious adverse event between the Nilotinib 300 group and the placebo were also compared using a Poisson regression model||||5.7409|0.0472|0.5940
71062904|NCT03349060|141634536|SUPERIORITY||Difference in Percentage|43.3|||<|0.0001|TWO_SIDED|95.0|33.1|53.6|||Cochran-Mantel-Haenszel|||Week 2: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||53.6|33.1|<0.0001
71110647|NCT00444925|141726850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||<0.0001
71110648|NCT00444925|141726850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.6||0.7288|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.7288
70941751|NCT04748445|141383935|OTHER||Slope|-2.784|STANDARD_ERROR_OF_MEAN|1.667||0.0974|TWO_SIDED|90.0|-5.547|-2.155|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 01 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit it was 10\^-5. For lower limit, estimated value and dispersion value it was 10\^-3).||-2.155|-5.547|0.0974
71062905|NCT03349060|141634536|SUPERIORITY||Difference in Percentage|12.5||||0.1138|TWO_SIDED|95.0|-3.0|28.0|||Cochran-Mantel-Haenszel|||Week 4: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||28.0|-3.0|0.1138
71062906|NCT03349060|141634536|SUPERIORITY||Difference in Percentage|41.8|||<|0.0001|TWO_SIDED|95.0|26.2|57.4|||Cochran-Mantel-Haenszel|||Week 4: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||57.4|26.2|<0.0001
71062907|NCT03349060|141634536|SUPERIORITY||Difference in Percentage|28.7|||<|0.0001|TWO_SIDED|95.0|15.3|42.1|||Cochran-Mantel-Haenszel|||Week 12: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||42.1|15.3|<0.0001
71062908|NCT03349060|141634536|SUPERIORITY||Difference in Percentage|47.8|||<|0.0001|TWO_SIDED|95.0|34.6|61.1|||Cochran-Mantel-Haenszel|||Week 12: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||61.1|34.6|<0.0001
71110649|NCT00444925|141726850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
71110650|NCT00444925|141726850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||<0.0001
71062909|NCT03349060|141634537|SUPERIORITY||Difference in least squares (LS) mean|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.6|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-1.4|<0.0001
71062910|NCT03349060|141634537|SUPERIORITY||Difference in LS mean|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.0|-1.2|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.2|-2.0|<0.0001
71062911|NCT03349060|141634537|SUPERIORITY||Difference in LS mean|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.6|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-1.6|<0.0001
71110651|NCT00444925|141726850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.2473|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.2473
71110652|NCT00444925|141726850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
71110653|NCT00444925|141726850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||<0.0001
71110654|NCT00444925|141726850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.7||0.1047|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.1047
71110655|NCT00444925|141726851|SUPERIORITY_OR_OTHER|||||||0.0143||95.0|||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 1||||0.0143
71110656|NCT00444925|141726851|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 4||||<0.0001
71110657|NCT00444925|141726851|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 12||||<0.0001
70937156|NCT03205488|141374154|NON_INFERIORITY|The hypotheses of interest (H0: δ ≤ -9.8 (7 x 1.4) vs. HA: δ \> -9.8) where δ represents the change from baseline to 6 months using the MDS-UPDRS Part III ON in the Nilotinib 150 mg treatment group. The hypotheses of interest were evaluated based on an assessment of parameter estimates from a non-linear mixed effects model, adjusted for a participant's Levodopa Equivalent Daily Dose (LEDD) at each time point.|Slope|1.05||||0.0001|ONE_SIDED|90.0|-0.78||||Mixed Models Analysis|||The key secondary objective is to conduct a futility analysis within each treatment group which examines the observed change in the MDS-UPDRS Part III ON within the two dose groups compared to previously reported changes from the Pagan et al (2016) study (NCT02281474).|||-0.78|0.0001
70937157|NCT03205488|141374154|NON_INFERIORITY|The hypotheses of interest (H0: δ ≤ -9.8 (7 x 1.4) vs. HA: δ \> -9.8) where δ represents the change from baseline to 6 months using the MDS-UPDRS Part III ON in the Nilotinib 300 mg treatment group. The hypotheses of interest were evaluated based on an assessment of parameter estimates from a non-linear mixed effects model, adjusted for a participant's Levodopa Equivalent Daily Dose (LEDD) at each time point.|Slope|0.93||||0.0001|ONE_SIDED|90.0|-0.89||||Mixed Models Analysis|||The key secondary objective is to conduct a futility analysis within each treatment group which examines the observed change in the MDS-UPDRS Part III ON within the two dose groups compared to previously reported changes from the Pagan et al (2016) study (NCT02281474).|||-0.89|0.0001
70937158|NCT03205488|141374154|EQUIVALENCE|H0 : β1 = β 2 = β 3, where β represents the slope for each group. HA : at least one β i ≠ β j. Using the same LMM as in the key secondary analysis, a two degree of freedom test was used to test for any differences in the slopes from baseline to 1 month for the three treatment groups.||||||0.031|||||||Mixed Models Analysis|||Additional secondary objective #1 is to establish the degree of symptomatic effect of Nilotinib as measured by the change in the MDS\_UPDRS Part III ON score between baseline and 1 month.|In order to assess which group may be driving these findings, pairwise comparisons were also utilized (Nilotinib 150 vs PBO at 1 Month, Nilotinib 300 vs PBO at 1 month, Nilotinib 300 vs Nilotinib 150 at 1 month).|||0.031
71062912|NCT03349060|141634537|SUPERIORITY||Difference in LS mean|-2.2|||<|0.0001|TWO_SIDED|95.0|-2.8|-1.7|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.7|-2.8|<0.0001
71062913|NCT03349060|141634537|SUPERIORITY||Difference in LS mean|-0.9||||0.0035|TWO_SIDED|95.0|-1.5|-0.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.3|-1.5|0.0035
71062914|NCT03349060|141634537|SUPERIORITY||Difference in LS mean|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.3|-2.5|<0.0001
71062915|NCT03349060|141634537|SUPERIORITY||Difference in LS mean|-1.1||||0.001|TWO_SIDED|95.0|-1.7|-0.4|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.4|-1.7|0.0010
71062916|NCT03349060|141634537|SUPERIORITY||Difference in LS mean|-2.1|||<|0.0001|TWO_SIDED|95.0|-2.7|-1.4|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.4|-2.7|<0.0001
71062917|NCT03349060|141634538|SUPERIORITY||Difference in LS mean|-1.3||||0.0002|TWO_SIDED|95.0|-2.0|-0.6|||Mixed Models Analysis|||MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-2.0|0.0002
71062918|NCT03349060|141634538|SUPERIORITY||Difference in LS mean|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.6|||Mixed Models Analysis|||MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.6|-3.0|<0.0001
71062919|NCT03349060|141634539|SUPERIORITY|||||||0.0071||||||P-value was controlled by randomization strata.|Log Rank|||||||0.0071
71062920|NCT03349060|141634539|SUPERIORITY||||||<|0.0001||||||P-value was controlled by randomization strata.|Log Rank|||||||<0.0001
71062921|NCT03349060|141634540|SUPERIORITY||Difference in Percentage|6.5||||0.0869|TWO_SIDED|95.0|-0.3|13.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||13.3|-0.3|0.0869
71062922|NCT03349060|141634540|SUPERIORITY||Difference in Percentage|20.3||||0.0001|TWO_SIDED|95.0|12.0|28.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||28.6|12.0|0.0001
71062923|NCT03349060|141634540|SUPERIORITY||Difference in Percentage|13.1||||0.0259|TWO_SIDED|95.0|2.6|23.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.6|2.6|0.0259
71062924|NCT03349060|141634540|SUPERIORITY||Difference in Percentage|33.0|||<|0.0001|TWO_SIDED|95.0|21.7|44.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||44.2|21.7|<0.0001
71110658|NCT00444925|141726852|SUPERIORITY_OR_OTHER|||||||0.0773||95.0|||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 1||||0.0773
71110659|NCT00444925|141726852|SUPERIORITY_OR_OTHER|||||||0.0017||95.0|||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 4||||0.0017
71110660|NCT00444925|141726852|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 12||||0.0008
71062925|NCT03349060|141634540|SUPERIORITY||Difference in Percentage|25.0||||0.0001|TWO_SIDED|95.0|14.2|35.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.8|14.2|0.0001
71062926|NCT03349060|141634540|SUPERIORITY||Difference in Percentage|44.6|||<|0.0001|TWO_SIDED|95.0|33.6|55.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||55.6|33.6|<0.0001
71062927|NCT03349060|141634541|SUPERIORITY||Difference in Percentage|3.9||||0.0802|TWO_SIDED|95.0|-0.7|8.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||8.5|-0.7|0.0802
71062928|NCT03349060|141634541|SUPERIORITY||Difference in Percentage|9.8||||0.0045|TWO_SIDED|95.0|4.0|15.7||P-value was adjusted by randomization strata (baseline disease severity and age category)|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||15.7|4.0|0.0045
70852556|NCT01675167|141193904|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.98|||<|1e-05|TWO_SIDED|95.0|-1.32|-0.64||P value was adjusted using weighted z-test (CHW).|ANCOVA|||||-0.64|-1.32|<.00001
71062929|NCT03349060|141634541|SUPERIORITY||Difference in Percentage|5.2||||0.1888|TWO_SIDED|95.0|-1.9|12.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||12.4|-1.9|0.1888
71062930|NCT03349060|141634541|SUPERIORITY||Difference in Percentage|21.7|||<|0.0001|TWO_SIDED|95.0|13.0|30.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||30.5|13.0|<0.0001
71062931|NCT03349060|141634541|SUPERIORITY||Difference in Percentage|13.8||||0.0071|TWO_SIDED|95.0|5.2|22.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||22.4|5.2|0.0071
71062932|NCT03349060|141634541|SUPERIORITY||Difference in Percentage|29.3|||<|0.0001|TWO_SIDED|95.0|19.8|38.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.7|19.8|<0.0001
71062933|NCT03349060|141634542|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.8|3.8||P-value could not be calculated since percentage of participants with event was 0.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.8|-3.8|
71110661|NCT00444925|141726853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|STANDARD_ERROR_OF_MEAN|1.5|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment difference Fesoterodine vs placebo at Week 12||||<0.0001
71110662|NCT00444925|141726854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.2|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL concern domain.||||<0.0001
71110663|NCT00444925|141726854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL coping domain.||||<0.0001
71110664|NCT00444925|141726854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|STANDARD_DEVIATION|1.5||0.0008|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL sleep domain.||||0.0008
71110665|NCT00444925|141726854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL social interaction domain.||||<0.0001
71110666|NCT00444925|141726854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.3|STANDARD_ERROR_OF_MEAN|1.3|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL scale score total.||||<0.0001
70937159|NCT03205488|141374154|EQUIVALENCE|H0 : β1 = β 2 = β 3, where β represents the slope for each group. HA : at least one β i ≠ β j. For this analysis, a separate LMM was constructed, modeling the change from final visit on study drug to the 30 and 60 day follow up visits, while adjusting for the MDS-UPDRS Part III ON scores at the final visit on study drug as well as the Levodopa Equivalent Daily Dose (LEDD) at each visit.||||||0.47|||||||Mixed Models Analysis|||Additional secondary objective #2 is to establish the degree of symptomatic effect of Nilotinib as measured by the change in the MDS\_UPDRS Part III ON score between the final visit on study drug and 30 days off study drug.||||0.47
70937160|NCT03205488|141374154|EQUIVALENCE|H0 : β1 = β 2 = β 3, where β represents the slope for each group. HA : at least one β i ≠ β j. Using the same LMM as in the key secondary analysis, a two degree of freedom test was used to test for any differences in the slopes from baseline to 6 months for the three treatment groups.||||||0.077|||||||Mixed Models Analysis|||Additional secondary objective #3 is to assess the impact of Nilotinib on the progression of PD disability as measured by the change in the MDS\_UPDRS Part III ON score between baseline and 6 months.|Pairwise comparisons were also examined for trends (Active 150 vs PBO at 6 Months, Active 300 vs PBO at 6 months).|||0.077
70937161|NCT03205488|141374154|EQUIVALENCE|H0 : β1 = β 2 = β 3, where β represents the slope for each group. HA : at least one β i ≠ β j. Using a similar LMM as in the key secondary analysis, except simplified to only include baseline, month 3 and month 6, a two degree of freedom test was used to test for any differences in the slopes from baseline to 6 months for the three treatment groups.||||||0.17|||||||Mixed Models Analysis|||Additional secondary objective #3 is to assess the impact of Nilotinib on the progression of PD disability as measured by the change in the MDS\_UPDRS Part III OFF score between baseline and 6 months.||||0.17
71062934|NCT03349060|141634542|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.8|3.8||P-value could not be calculated since percentage of participants with event was 0.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.8|-3.8|
71062935|NCT03349060|141634542|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.9|3.9||P-value could not be calculated since percentage of participants with event was 0.||||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.9|-3.9|
71062936|NCT03349060|141634542|SUPERIORITY||Difference in Percentage|6.5||||0.0234|TWO_SIDED|95.0|1.3|11.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.7|1.3|0.0234
71062937|NCT03349060|141634542|SUPERIORITY||Difference in Percentage|4.6||||0.0592|TWO_SIDED|95.0|-0.3|9.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.5|-0.3|0.0592
71062938|NCT03349060|141634542|SUPERIORITY||Difference in Percentage|11.7||||0.0022|TWO_SIDED|95.0|5.5|17.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||17.9|5.5|0.0022
71062939|NCT03349060|141634542|SUPERIORITY||Difference in Percentage|7.0||||0.019|TWO_SIDED|95.0|1.7|12.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||12.3|1.7|0.0190
71062940|NCT03349060|141634542|SUPERIORITY||Difference in Percentage|13.1||||0.001|TWO_SIDED|95.0|6.7|19.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||19.4|6.7|0.0010
71062941|NCT03349060|141634543|SUPERIORITY||Difference in Percentage|24.0|||<|0.0001|TWO_SIDED|95.0|13.9|34.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||34.1|13.9|<0.0001
71062942|NCT03349060|141634543|SUPERIORITY||Difference in Percentage|45.1|||<|0.0001|TWO_SIDED|95.0|34.7|55.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||55.5|34.7|<0.0001
71062943|NCT03349060|141634543|SUPERIORITY||Difference in Percentage|33.5|||<|0.0001|TWO_SIDED|95.0|21.6|45.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||45.4|21.6|<0.0001
70937162|NCT04867382|141374155|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.27||0.63|TWO_SIDED||||||t-test, 2 sided|||||||.63
70937163|NCT04867382|141374156|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.17||0.27|TWO_SIDED||||||t-test, 2 sided|||||||0.27
71062944|NCT03349060|141634543|SUPERIORITY||Difference in Percentage|52.7|||<|0.0001|TWO_SIDED|95.0|41.2|64.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||64.2|41.2|<0.0001
71062945|NCT03349060|141634543|SUPERIORITY||Difference in Percentage|34.1|||<|0.0001|TWO_SIDED|95.0|21.9|46.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||46.3|21.9|<0.0001
71062946|NCT03349060|141634543|SUPERIORITY||Difference in Percentage|52.9|||<|0.0001|TWO_SIDED|95.0|41.3|64.6|||Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||64.6|41.3|<0.0001
71062947|NCT03349060|141634543|SUPERIORITY||Difference in Percentage|35.3|||<|0.0001|TWO_SIDED|95.0|23.3|47.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||47.4|23.3|<0.0001
71062948|NCT03349060|141634543|SUPERIORITY||Difference in Percentage|53.5|||<|0.0001|TWO_SIDED|95.0|42.0|65.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||65.0|42.0|<0.0001
71062949|NCT03349060|141634544|SUPERIORITY||Difference in Percentage|0.6||||0.7285|TWO_SIDED|95.0|-3.9|5.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.2|-3.9|0.7285
71062950|NCT03349060|141634544|SUPERIORITY||Difference in Percentage|4.0||||0.1448|TWO_SIDED|95.0|-1.2|9.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.2|-1.2|0.1448
70852557|NCT01675167|141193905|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by stratum (dose level)||Responders with ≥30% pain reduction||||<.0001
70937164|NCT04867382|141374157|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.22||0.37|TWO_SIDED||||||t-test, 2 sided|||||||.37
71062951|NCT03349060|141634544|SUPERIORITY||Difference in Percentage|3.9||||0.2576|TWO_SIDED|95.0|-2.6|10.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||10.5|-2.6|0.2576
71062952|NCT03349060|141634544|SUPERIORITY||Difference in Percentage|20.4||||0.0001|TWO_SIDED|95.0|12.0|28.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||28.9|12.0|0.0001
70937165|NCT04867382|141374158|SUPERIORITY||Odds Ratio (OR)|1.75||||0.12|TWO_SIDED|95.0|0.86|3.57|||Regression, Logistic|||||3.57|0.86|.12
70937166|NCT01326455|141374168|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|TWO_SIDED|95.0|||||Chi-squared|||Lancaster et. al. (2004) quoted the number 30 as a general sample size for a pilot study. Each arm of this study had 25 people (due to time constraints), giving a total of 75 people. The data were analyzed using t-tests for equality of means, a two-way analysis of variance (ANOVA), and chi-square. Significance was set at p \< 0.05.||||0.25
71062953|NCT03349060|141634544|SUPERIORITY||Difference in Percentage|9.0||||0.0423|TWO_SIDED|95.0|1.3|16.8|||Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||16.8|1.3|0.0423
71062954|NCT03349060|141634544|SUPERIORITY||Difference in Percentage|28.0|||<|0.0001|TWO_SIDED|95.0|18.7|37.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||37.2|18.7|<0.0001
71062955|NCT03349060|141634544|SUPERIORITY||Difference in Percentage|13.3||||0.0066|TWO_SIDED|95.0|5.4|21.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||21.2|5.4|0.0066
71062956|NCT03349060|141634544|SUPERIORITY||Difference in Percentage|33.4|||<|0.0001|TWO_SIDED|95.0|24.3|42.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||42.5|24.3|<0.0001
71062957|NCT03349060|141634545|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.8|3.8||P-value could not be calculated since percentage of participants with events was 0.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.8|-3.8|
71110667|NCT00444925|141726855|SUPERIORITY_OR_OTHER|||||||0.0072||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs placebo at Week 1.||||0.0072
71110668|NCT00444925|141726855|SUPERIORITY_OR_OTHER|||||||0.0116||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Tolterodine ER vs placebo at Week 1.||||0.0116
71110669|NCT00444925|141726855|SUPERIORITY_OR_OTHER|||||||0.7828||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.7828
71110670|NCT00444925|141726855|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
71110671|NCT00444925|141726855|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Tolterodine ER vs placebo at Week 4.||||<0.0001
70937167|NCT01326455|141374169|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47|||||||Chi-squared|||||||0.47
71062958|NCT03349060|141634545|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.8|3.8||P-value could not be calculated since percentage of participants with events was 0.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.8|-3.8|
71110672|NCT00444925|141726855|SUPERIORITY_OR_OTHER|||||||0.3104||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.3104
71110673|NCT00444925|141726855|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
71110674|NCT00444925|141726855|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Tolterodine ER vs placebo at Week 12.||||0.0004
71110675|NCT00444925|141726855|SUPERIORITY_OR_OTHER|||||||0.0153||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.0153
70937168|NCT01326455|141374170|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|95.0|||||ANOVA|||||||0.002
70937169|NCT01326455|141374170|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
70937170|NCT01326455|141374170|SUPERIORITY_OR_OTHER_LEGACY|||||||0.144|||||||ANOVA|||||||0.144
71062959|NCT03349060|141634545|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.9|3.9||P-value could not be calculated since percentage of participants with events was 0.||||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.9|-3.9|
71110676|NCT01342926|141726896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|||||TWO_SIDED|90.0|-0.57|0.43|||||6 months visit|||0.43|-0.57|
71110677|NCT01342926|141726896|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.2|||||TWO_SIDED|90.0|-0.31|0.71|||||12 months visit|||0.71|-0.31|
71110678|NCT01342926|141726896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||||TWO_SIDED|90.0|-0.33|0.68|||||18 months visit|||0.68|-0.33|
71110679|NCT01342926|141726896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|||||TWO_SIDED|90.0|-0.71|0.26|||||6 months visit|||0.26|-0.71|
71110680|NCT01342926|141726896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||||TWO_SIDED|90.0|-0.26|0.72|||||12 months visit|||0.72|-0.26|
71110681|NCT01342926|141726896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|||||TWO_SIDED|90.0|-0.21|0.77|||||18 months visit|||0.77|-0.21|
71110682|NCT01342926|141726896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|||||TWO_SIDED|90.0|-0.66|0.29|||||6 months visit|||0.29|-0.66|
71110683|NCT01342926|141726896|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.28|||||TWO_SIDED|90.0|-0.19|0.75|||||12 months visit|||0.75|-0.19|
71110684|NCT01342926|141726896|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.39|||||TWO_SIDED|90.0|-0.08|0.86|||||18 months visit|||0.86|-0.08|
71110685|NCT01342926|141726904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||||TWO_SIDED|90.0|-0.34|0.61|||||6 months visit|||0.61|-0.34|
71110686|NCT01342926|141726904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|||||TWO_SIDED|90.0|-0.07|0.89|||||12 months visit|||0.89|-0.07|
71110687|NCT01342926|141726904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42|||||TWO_SIDED|90.0|-0.06|0.89|||||18 months visit|||0.89|-0.06|
71110688|NCT01342926|141726904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|||||TWO_SIDED|90.0|-0.55|0.37|||||6 months visit|||0.37|-0.55|
71110689|NCT01342926|141726904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||||TWO_SIDED|90.0|-0.13|0.8|||||12 months visit|||0.80|-0.13|
71110690|NCT01342926|141726904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||||TWO_SIDED|90.0|-0.3|0.63|||||18 months visit|||0.63|-0.30|
71110691|NCT01342926|141726904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|||||TWO_SIDED|90.0|-0.31|0.57|||||6 months visit|||0.57|-0.31|
71110692|NCT01342926|141726904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.54|||||TWO_SIDED|90.0|0.1|0.99|||||12 months visit|||0.99|0.10|
71110693|NCT01342926|141726904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91|||||TWO_SIDED|90.0|0.47|1.36|||||18 months visit|||1.36|0.47|
71110694|NCT01342926|141726905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|90.0|-0.34|0.55|||||6 months visit|||0.55|-0.34|
71110695|NCT01342926|141726905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|||||TWO_SIDED|90.0|0.0|0.9|||||12 months visit|||0.90|0.00|
71110696|NCT01342926|141726905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||||TWO_SIDED|90.0|-0.12|0.77|||||18 months visit|||0.77|-0.12|
71110697|NCT01342926|141726905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|||||TWO_SIDED|90.0|-0.51|0.35|||||6 months visit|||0.35|-0.51|
71110698|NCT01342926|141726905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||||TWO_SIDED|90.0|-0.21|0.66|||||12 months visit|||0.66|-0.21|
71110699|NCT01342926|141726905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|||||TWO_SIDED|90.0|-0.32|0.55|||||18 months visit|||0.55|-0.32|
71110700|NCT01342926|141726905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|90.0|-0.48|0.35|||||6 months visit|||0.35|-0.48|
71110701|NCT01342926|141726905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|90.0|-0.22|0.62|||||12 months visit|||0.62|-0.22|
71110702|NCT01342926|141726905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||||TWO_SIDED|90.0|0.08|0.92|||||18 months visit|||0.92|0.08|
71062960|NCT03349060|141634545|SUPERIORITY||Difference in Percentage|6.5||||0.0234|TWO_SIDED|95.0|1.3|11.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.7|1.3|0.0234
71062961|NCT03349060|141634545|SUPERIORITY||Difference in Percentage|4.6||||0.0604|TWO_SIDED|95.0|-0.3|9.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.5|-0.3|0.0604
71062962|NCT03349060|141634545|SUPERIORITY||Difference in Percentage|11.7||||0.0022|TWO_SIDED|95.0|5.5|17.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||17.9|5.5|0.0022
71062963|NCT03349060|141634545|SUPERIORITY||Difference in Percentage|6.4||||0.0255|TWO_SIDED|95.0|1.2|11.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.6|1.2|0.0255
71062964|NCT03349060|141634545|SUPERIORITY||Difference in Percentage|13.1||||0.001|TWO_SIDED|95.0|6.7|19.4|||Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||19.4|6.7|0.0010
71062965|NCT03349060|141634546|SUPERIORITY||Difference in LS mean|-5.8|||<|0.0001|TWO_SIDED|95.0|-8.2|-3.3|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-3.3|-8.2|<0.0001
71062966|NCT03349060|141634546|SUPERIORITY||Difference in LS mean|-10.6|||<|0.0001|TWO_SIDED|95.0|-13.0|-8.1|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-8.1|-13.0|<0.0001
71062967|NCT03349060|141634546|SUPERIORITY||Difference in LS mean|-7.9|||<|0.0001|TWO_SIDED|95.0|-10.7|-5.0|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-5.0|-10.7|<0.0001
71110703|NCT03382912|141726914|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.3|5.9|||||Odds Ratio stratified based on tumor histology at randomization (interactive web response system (IWRS)), smoking status (IWRS). Confidence intervals were based on the Clopper-Pearson method.|||5.9|0.3|
71110704|NCT03382912|141726915|SUPERIORITY||Hazard Ratio (HR)|1.006|||||TWO_SIDED|95.0|0.519|1.951|||||The estimate of the hazard ration (HR) stratified based on tumor histology at randomization (interactive web response system (IWRS)) and smoking status (IWRS).|||1.951|0.519|
71110705|NCT03382912|141726916|SUPERIORITY||Hazard Ratio (HR)|1.871|||||TWO_SIDED|95.0|0.772|4.532|||||||The estimate of the hazard ration (HR) stratified based on tumor histology at randomization (IWRS) and smoking status (IWRS).|4.532|0.772|
71062968|NCT03349060|141634546|SUPERIORITY||Difference in LS mean|-12.7|||<|0.0001|TWO_SIDED|95.0|-15.6|-9.9|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-9.9|-15.6|<0.0001
71062969|NCT03349060|141634546|SUPERIORITY||Difference in LS mean|-8.5|||<|0.0001|TWO_SIDED|95.0|-11.6|-5.5|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-5.5|-11.6|<0.0001
71062970|NCT03349060|141634546|SUPERIORITY||Difference in LS mean|-13.5|||<|0.0001|TWO_SIDED|95.0|-16.5|-10.4|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-10.4|-16.5|<0.0001
71062971|NCT03349060|141634546|SUPERIORITY||Difference in LS mean|-8.3|||<|0.0001|TWO_SIDED|95.0|-11.6|-5.1|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-5.1|-11.6|<0.0001
71062972|NCT03349060|141634546|SUPERIORITY||Difference in LS mean|-14.0|||<|0.0001|TWO_SIDED|95.0|-17.3|-10.8|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-10.8|-17.3|<0.0001
71062973|NCT03349060|141634547|SUPERIORITY||Difference in LS mean|-7.8||||0.0004|TWO_SIDED|95.0|-12.1|-3.5|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-3.5|-12.1|0.0004
71062974|NCT03349060|141634547|SUPERIORITY||Difference in LS mean|-14.8|||<|0.0001|TWO_SIDED|95.0|-19.0|-10.5|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-10.5|-19.0|<0.0001
71062975|NCT03349060|141634547|SUPERIORITY||Difference in LS mean|-11.7|||<|0.0001|TWO_SIDED|95.0|-16.6|-6.9|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-6.9|-16.6|<0.0001
71062976|NCT03349060|141634547|SUPERIORITY||Difference in LS mean|-18.5|||<|0.0001|TWO_SIDED|95.0|-23.4|-13.6|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-13.6|-23.4|<0.0001
70937171|NCT01326455|141374171|SUPERIORITY_OR_OTHER_LEGACY|||||||0.372|||||||ANOVA|||||||0.372
70937172|NCT01326455|141374172|SUPERIORITY_OR_OTHER_LEGACY|||||||0.468|||||||Chi-squared|||||||0.468
70937173|NCT02008916|141374181|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0093|TWO_SIDED|95.0|1.24|4.69|||Regression, Logistic|||||4.69|1.24|0.0093
70937174|NCT02008916|141374181|SUPERIORITY||Odds Ratio (OR)|2.68||||0.0037|TWO_SIDED|95.0|1.38|5.21|||Regression, Logistic|||||5.21|1.38|0.0037
70937175|NCT02008916|141374182|SUPERIORITY||Odds Ratio (OR)|2.59||||0.01|TWO_SIDED|95.0|1.26|5.35|||Regression, Logistic|||||5.35|1.26|0.0100
70937176|NCT02008916|141374182|SUPERIORITY||Odds Ratio (OR)|2.81||||0.0051|TWO_SIDED|95.0|1.36|5.78|||Regression, Logistic|||||5.78|1.36|0.0051
71062977|NCT03349060|141634547|SUPERIORITY||Difference in LS mean|-14.3|||<|0.0001|TWO_SIDED|95.0|-19.7|-9.0|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-9.0|-19.7|<0.0001
70852558|NCT01675167|141193905|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by Stratum (Dose Level)||Responders with ≥50% pain reduction||||<.0001
70937177|NCT02008916|141374183|SUPERIORITY||Relative treatment effect|0.51|||<|0.0001|TWO_SIDED|95.0|0.38|0.68|||Mixed Models Analysis||Relative treatment effect = exponential of the difference in LSM on the log e scale or the geometric LSM ratio on the original scale. For values less than 1, AIN457 has a greater reduction than Placebo.|||0.68|0.38|<0.0001
70937178|NCT02008916|141374183|SUPERIORITY||Relative treatment effect|0.44|||<|0.0001|TWO_SIDED|95.0|0.33|0.6|||Mixed Models Analysis||Relative treatment effect = exponential of the difference in LSM on the log e scale or the geometric LSM ratio on the original scale. For values less than 1, AIN457 has a greater reduction than Placebo.|||0.60|0.33|<0.0001
70937179|NCT02008916|141374184|SUPERIORITY||Odds Ratio (OR)|4.46||||0.0002|TWO_SIDED|95.0|2.01|9.92|||Regression, Logistic|||||9.92|2.01|0.0002
70937180|NCT02008916|141374184|SUPERIORITY||Odds Ratio (OR)|4.21||||0.0004|TWO_SIDED|95.0|1.89|9.38|||Regression, Logistic|||||9.38|1.89|0.0004
70937181|NCT02008916|141374185|SUPERIORITY||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.39||0.0347|TWO_SIDED|95.0|-1.6|-0.06|||Mixed Models Analysis|||||-0.06|-1.60|0.0347
70937182|NCT02008916|141374185|SUPERIORITY||Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|0.39||0.0018|TWO_SIDED|95.0|-2.0|-0.46|||Mixed Models Analysis|||||-0.46|-2.00|0.0018
70937183|NCT02008916|141374189|SUPERIORITY||Odds Ratio (OR)|7.71||||0.0593|TWO_SIDED|95.0|0.92|64.42|||Regression, Logistic|||||64.42|0.92|0.0593
70937184|NCT02008916|141374189|SUPERIORITY||Odds Ratio (OR)|19.39||||0.0046|TWO_SIDED|95.0|2.49|150.79|||Regression, Logistic|||||150.79|2.49|0.0046
70937185|NCT00090519|141374226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.969|TWO_SIDED|95.0|-0.714|0.686|||ANOVA|||||0.686|-0.714|0.969
70937186|NCT00090519|141374227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.09||||0.015|TWO_SIDED|95.0|0.21|1.97||P-value is for change from baseline.|ANCOVA|||||1.97|0.21|0.015
71062978|NCT03349060|141634547|SUPERIORITY||Difference in LS mean|-22.6|||<|0.0001|TWO_SIDED|95.0|-28.0|-17.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-17.3|-28.0|<0.0001
70937187|NCT00090519|141374228|SUPERIORITY_OR_OTHER|||||||0.577||95.0||||P-value is for first occurrence of focal/grid photocoagulation yes versus no.|Chi-squared|||||||0.577
70937188|NCT00090519|141374229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.041|TWO_SIDED|95.0|0.02|0.87||P-value is for change from baseline.|ANCOVA|||||0.87|0.02|0.041
70937189|NCT00090519|141374230|SUPERIORITY_OR_OTHER|||||||0.475||95.0||||P-value is for progression of nonproliferative diabetic retinopathy (DR) by seven-field stereo fundus photography progression versus no progression.|Chi-squared|||||||0.475
70937190|NCT00090519|141374231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.52||||0.211|TWO_SIDED|95.0|-0.87|3.92||P-value is for change from baseline.|ANCOVA|||||3.92|-0.87|0.211
70937191|NCT00090519|141374232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|63.22||||0.365|TWO_SIDED|95.0|-73.68|200.12||P-value is for change from baseline.|t-test, 2 sided|||||200.12|-73.68|0.365
70937192|NCT00090519|141374233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.52||||0.009|TWO_SIDED|95.0|0.38|2.66||P-value is for change from baseline.|ANCOVA|||||2.66|0.38|0.009
70937193|NCT00090519|141374235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.081|TWO_SIDED|95.0|0.2|1.12||P-value is for occurrence of sustained moderate visual loss (SMVL) in a diabetic retinopathy (DR) study eye yes versus no.|Chi-squared|||||1.12|0.20|0.081
70937194|NCT02548585|141374283|SUPERIORITY||||||<|0.0001|||||||ANCOVA|p-value was based on pairwise comparison using analysis of covariance (ANCOVA) adjusted by baseline value.||||||< 0.0001
70937195|NCT02548585|141374284|SUPERIORITY|||||||0.0008|||||||ANCOVA|p-value was based on pairwise comparison using ANCOVA adjusted by baseline value.||||||0.0008
70937196|NCT01782209|141374309|OTHER||Incidence|17.3|||||TWO_SIDED|95.0|13.4|21.8|||||95% Clopper-Pearson Confidence Interval|||21.8|13.4|
70937197|NCT02033174|141374310|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.05
70937198|NCT03242863|141374311|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
70937199|NCT03242863|141374312|SUPERIORITY|||||||0.0015|||||||Mixed Models Analysis|||||||0.0015
70937200|NCT03242863|141374313|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
70937201|NCT03242863|141374314|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
70937202|NCT01079949|141374322|SUPERIORITY_OR_OTHER|||||||0.5739||95.0|||||Wilcoxon two sample test|||||||0.5739
70937203|NCT01079949|141374327|SUPERIORITY_OR_OTHER|||||||0.1734||95.0|||||Wilcoxon two sample test|||||||0.1734
70937204|NCT01079949|141374328|SUPERIORITY_OR_OTHER|||||||0.0642||95.0|||||Wilcoxon two sample test|||||||0.0642
70937205|NCT01079949|141374332|SUPERIORITY_OR_OTHER|||||||0.408||95.0|||||Wilcoxon two sample test|||||||0.4080
70937206|NCT01079949|141374335|SUPERIORITY_OR_OTHER|||||||0.0648||95.0|||||Wilcoxon two sample test|||||||0.0648
70937207|NCT01079949|141374336|SUPERIORITY_OR_OTHER|||||||0.6799||95.0|||||ANOVA|||||||0.6799
70937208|NCT01079949|141374337|SUPERIORITY_OR_OTHER|||||||0.0634||95.0|||||Wilcoxon two sample test|||||||0.0634
70852559|NCT02522624|141194051|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Linear|||||||<.001
71062979|NCT03349060|141634547|SUPERIORITY||Difference in LS mean|-13.8|||<|0.0001|TWO_SIDED|95.0|-19.3|-8.2|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-8.2|-19.3|<0.0001
71062980|NCT03349060|141634547|SUPERIORITY||Difference in LS mean|-22.0|||<|0.0001|TWO_SIDED|95.0|-27.6|-16.5|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-16.5|-27.6|<0.0001
71062981|NCT03349060|141634548|SUPERIORITY||Difference in Percentage|1.3||||0.521|TWO_SIDED|95.0|-3.4|6.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.0|-3.4|0.5210
71062982|NCT03349060|141634548|SUPERIORITY||Difference in Percentage|4.0||||0.1416|TWO_SIDED|95.0|-1.3|9.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.3|-1.3|0.1416
71062983|NCT03349060|141634548|SUPERIORITY||Difference in Percentage|4.6||||0.2002|TWO_SIDED|95.0|-2.1|11.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.2|-2.1|0.2002
71062984|NCT03349060|141634548|SUPERIORITY||Difference in Percentage|23.6|||<|0.0001|TWO_SIDED|95.0|15.1|32.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||32.2|15.1|<0.0001
71110706|NCT03382912|141726917|SUPERIORITY||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|0.4|4.1|||||Odds Ratio stratified based on tumor histology at randomization (IWRS) and smoking status (IWRS). Confidence intervals were based on the Clopper-Pearson method.|||4.1|0.4|
71110707|NCT00707993|141726945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|||||ONE_SIDED|97.5||0.13|||ANCOVA|Treatment, randomization schedule, and geographic region as class effects; baseline value for the endpoint as a continuous covariate.||Primary null hypothesis: the average Week 52 HbA1c change from Baseline for alogliptin is inferior to that for glipizide (1-sided 97.5% CI \[alpha=0.025\] compared to non-inferiority margin of 0.4%). If the primary null hypothesis was rejected (non-inferiority demonstrated), an additional comparison for statistical superiority of alogliptin was performed. The CI was re-evaluated; statistical superiority declared if the upper limit was \< 0%.||0.13||
70937209|NCT01079949|141374339|SUPERIORITY_OR_OTHER|||||||0.0166||95.0|||||Wilcoxon two sample test|||||||0.0166
70937210|NCT01079949|141374340|SUPERIORITY_OR_OTHER|||||||0.8812||95.0|||||ANOVA|||||||0.8812
71062985|NCT03349060|141634548|SUPERIORITY||Difference in Percentage|9.6||||0.0434|TWO_SIDED|95.0|1.3|17.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||17.9|1.3|0.0434
71062986|NCT03349060|141634548|SUPERIORITY||Difference in Percentage|26.6|||<|0.0001|TWO_SIDED|95.0|17.1|36.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||36.2|17.1|<0.0001
71062987|NCT03349060|141634548|SUPERIORITY||Difference in Percentage|15.8||||0.0019|TWO_SIDED|95.0|7.5|24.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||24.0|7.5|0.0019
71062988|NCT03349060|141634548|SUPERIORITY||Difference in Percentage|33.3|||<|0.0001|TWO_SIDED|95.0|24.0|42.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||42.7|24.0|<0.0001
71062989|NCT03349060|141634549|SUPERIORITY||Difference in Percentage|10.8||||0.0151|TWO_SIDED|95.0|3.3|18.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||18.3|3.3|0.0151
71062990|NCT03349060|141634549|SUPERIORITY||Difference in Percentage|30.0|||<|0.0001|TWO_SIDED|95.0|21.0|39.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||39.0|21.0|<0.0001
71062991|NCT03349060|141634549|SUPERIORITY||Difference in Percentage|21.2||||0.001|TWO_SIDED|95.0|10.2|32.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||32.3|10.2|0.0010
71062992|NCT03349060|141634549|SUPERIORITY||Difference in Percentage|37.9|||<|0.0001|TWO_SIDED|95.0|26.6|49.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||49.3|26.6|<0.0001
70937211|NCT02144285|141374344|SUPERIORITY_OR_OTHER||Absolute Bioavailability|0.45|||||TWO_SIDED|90.0|0.34|0.6||||||||0.60|0.34|
70937212|NCT01513447|141374363|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Fisher Exact|||||||0.67
71062993|NCT03349060|141634549|SUPERIORITY||Difference in Percentage|23.5||||0.0003|TWO_SIDED|95.0|12.6|34.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||34.3|12.6|0.0003
71062994|NCT03349060|141634549|SUPERIORITY||Difference in Percentage|41.7|||<|0.0001|TWO_SIDED|95.0|30.7|52.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||52.7|30.7|<0.0001
71062995|NCT03349060|141634549|SUPERIORITY||Difference in Percentage|19.6||||0.0026|TWO_SIDED|95.0|8.1|31.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||31.1|8.1|0.0026
71062996|NCT03349060|141634549|SUPERIORITY||Difference in Percentage|40.0|||<|0.0001|TWO_SIDED|95.0|28.3|51.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||51.7|28.3|<0.0001
71062997|NCT03349060|141634550|SUPERIORITY||Difference in Percentage|1.3||||0.3151|TWO_SIDED|95.0|-2.9|5.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.6|-2.9|0.3151
71062998|NCT03349060|141634550|SUPERIORITY||Difference in Percentage|6.0||||0.0292|TWO_SIDED|95.0|0.7|11.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.3|0.7|0.0292
71062999|NCT03349060|141634550|SUPERIORITY||Difference in Percentage|-0.2||||0.9402|TWO_SIDED|95.0|-5.9|5.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.5|-5.9|0.9402
71063000|NCT03349060|141634550|SUPERIORITY||Difference in Percentage|15.3||||0.0019|TWO_SIDED|95.0|7.3|23.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.2|7.3|0.0019
71063001|NCT03349060|141634550|SUPERIORITY||Difference in Percentage|10.8||||0.0078|TWO_SIDED|95.0|4.2|17.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||17.4|4.2|0.0078
71063002|NCT03349060|141634550|SUPERIORITY||Difference in Percentage|22.2|||<|0.0001|TWO_SIDED|95.0|14.2|30.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||30.1|14.2|<0.0001
71063003|NCT03349060|141634550|SUPERIORITY||Difference in Percentage|8.2||||0.0528|TWO_SIDED|95.0|1.0|15.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||15.3|1.0|0.0528
71063004|NCT03349060|141634550|SUPERIORITY||Difference in Percentage|26.4|||<|0.0001|TWO_SIDED|95.0|17.6|35.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.3|17.6|<0.0001
71063005|NCT03349060|141634551|SUPERIORITY||Difference in LS mean|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.9|-0.6|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-1.9|<0.0001
71063006|NCT03349060|141634551|SUPERIORITY||Difference in LS mean|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.7|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.7|-3.0|<0.0001
71063007|NCT03349060|141634551|SUPERIORITY||Difference in LS mean|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.2|-0.9|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.9|-2.2|<0.0001
71063008|NCT03349060|141634551|SUPERIORITY||Difference in LS mean|-2.7|||<|0.0001|TWO_SIDED|95.0|-3.4|-2.0|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-2.0|-3.4|<0.0001
71063009|NCT03349060|141634551|SUPERIORITY||Difference in LS mean|-1.5|||<|0.0001|TWO_SIDED|95.0|-2.3|-0.8|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.8|-2.3|<0.0001
71063010|NCT03349060|141634551|SUPERIORITY||Difference in LS mean|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.8|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.8|-3.2|<0.0001
71063011|NCT03349060|141634551|SUPERIORITY||Difference in LS mean|-1.3||||0.0005|TWO_SIDED|95.0|-2.1|-0.6|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-2.1|0.0005
71063012|NCT03349060|141634551|SUPERIORITY||Difference in LS mean|-2.1|||<|0.0001|TWO_SIDED|95.0|-2.9|-1.4|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.4|-2.9|<0.0001
71063013|NCT03349060|141634552|SUPERIORITY||Difference in LS mean|-10.9|||<|0.0001|TWO_SIDED|95.0|-14.8|-7.0|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-7.0|-14.8|<0.0001
71063014|NCT03349060|141634552|SUPERIORITY||Difference in LS mean|-18.9|||<|0.0001|TWO_SIDED|95.0|-22.7|-15.1|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-15.1|-22.7|<0.0001
71063015|NCT03349060|141634552|SUPERIORITY||Difference in LS mean|-12.6|||<|0.0001|TWO_SIDED|95.0|-17.3|-7.8|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-7.8|-17.3|<.0001
71063016|NCT03349060|141634552|SUPERIORITY||Difference in LS mean|-22.1|||<|0.0001|TWO_SIDED|95.0|-26.8|-17.3|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-17.3|-26.8|<.0001
71063017|NCT03349060|141634552|SUPERIORITY||Difference in LS mean|-14.3|||<|0.0001|TWO_SIDED|95.0|-19.5|-9.0|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-9.0|-19.5|<.0001
70852560|NCT02522624|141194051|SUPERIORITY_OR_OTHER|||||||0.16||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Linear|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).||||0.16
70852561|NCT02522624|141194051|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Linear|||Controlling for Numeracy.||||<.001
71063018|NCT03349060|141634552|SUPERIORITY||Difference in LS mean|-22.0|||<|0.0001|TWO_SIDED|95.0|-27.2|-16.7|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-16.7|-27.2|<.0001
71063019|NCT03349060|141634552|SUPERIORITY||Difference in LS mean|-13.3|||<|0.0001|TWO_SIDED|95.0|-19.0|-7.7|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-7.7|-19.0|<0.0001
71063020|NCT03349060|141634552|SUPERIORITY||Difference in LS mean|-21.9|||<|0.0001|TWO_SIDED|95.0|-27.5|-16.3|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-16.3|-27.5|<.0001
71063021|NCT03349060|141634553|SUPERIORITY||Difference in Percentage|22.3||||0.0028|TWO_SIDED|95.0|8.7|35.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.9|8.7|0.0028
71063022|NCT03349060|141634553|SUPERIORITY||Difference in Percentage|40.1|||<|0.0001|TWO_SIDED|95.0|27.1|53.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||53.2|27.1|<0.0001
71063023|NCT03349060|141634553|SUPERIORITY||Difference in Percentage|17.1||||0.0217|TWO_SIDED|95.0|2.8|31.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||31.4|2.8|0.0217
71063024|NCT03349060|141634553|SUPERIORITY||Difference in Percentage|32.2|||<|0.0001|TWO_SIDED|95.0|18.5|45.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||45.9|18.5|<0.0001
71063025|NCT03349060|141634553|SUPERIORITY||Difference in Percentage|15.7||||0.0363|TWO_SIDED|95.0|1.4|30.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||30.0|1.4|0.0363
71078085|NCT01026818|141664582|SUPERIORITY_OR_OTHER||LS Mean Differences|2.48|STANDARD_ERROR_OF_MEAN|5.02||0.621|TWO_SIDED|95.0|-7.38|12.35||P-value is for Q3 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||12.35|-7.38|0.621
70937213|NCT01513447|141374364|SUPERIORITY_OR_OTHER||Mean Difference (Net)|102.0||||0.29|TWO_SIDED|95.0|-230.0|171.0|||Wilcoxon (Mann-Whitney)|||||171|-230|0.29
70937214|NCT01276509|141374365|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.05|STANDARD_ERROR_OF_MEAN|0.121||0.3393|TWO_SIDED|90.0|-0.149|0.249|||Mixed Models Analysis|||Difference from placebo at Week 8||0.249|-0.149|0.3393
70937215|NCT01276509|141374365|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.124|STANDARD_ERROR_OF_MEAN|0.117||0.1433|TWO_SIDED|90.0|-0.068|0.316|||Mixed Models Analysis|||Difference from placebo at Week 8||0.316|-0.068|0.1433
70937216|NCT01276509|141374365|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.15|STANDARD_ERROR_OF_MEAN|0.113||0.0922|TWO_SIDED|90.0|-0.036|0.335|||Mixed Models Analysis|||Difference from placebo at Week 8||0.335|-0.036|0.0922
71063026|NCT03349060|141634553|SUPERIORITY||Difference in Percentage|23.7||||0.0011|TWO_SIDED|95.0|9.8|37.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||37.7|9.8|0.0011
71063027|NCT03349060|141634553|SUPERIORITY||Difference in Percentage|20.1||||0.008|TWO_SIDED|95.0|5.8|34.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||34.5|5.8|0.0080
71063028|NCT03349060|141634553|SUPERIORITY||Difference in Percentage|29.1|||<|0.0001|TWO_SIDED|95.0|15.0|43.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||43.3|15.0|<0.0001
71063029|NCT03349060|141634554|SUPERIORITY||Difference in LS mean|-3.8|||<|0.0001|TWO_SIDED|95.0|-5.4|-2.2|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-2.2|-5.4|<0.0001
71063030|NCT03349060|141634554|SUPERIORITY||Difference in LS mean|-5.5|||<|0.0001|TWO_SIDED|95.0|-7.1|-3.9|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-3.9|-7.1|<0.0001
70937217|NCT01276509|141374365|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.034|STANDARD_ERROR_OF_MEAN|0.117||0.3864|TWO_SIDED|90.0|-0.158|0.225|||Mixed Models Analysis|||Difference from placebo at Week 12||0.225|-0.158|0.3864
71063031|NCT03349060|141634554|SUPERIORITY||Difference in LS mean|-3.3||||0.0001|TWO_SIDED|95.0|-5.0|-1.7|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.7|-5.0|0.0001
71063032|NCT03349060|141634554|SUPERIORITY||Difference in LS mean|-6.1|||<|0.0001|TWO_SIDED|95.0|-7.8|-4.5|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-4.5|-7.8|<.0001
70937218|NCT01276509|141374365|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.061|STANDARD_ERROR_OF_MEAN|0.117||0.3005|TWO_SIDED|90.0|-0.131|0.253|||Mixed Models Analysis|||Difference from placebo at Week 12||0.253|-0.131|0.3005
70937219|NCT01276509|141374365|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|-0.011|STANDARD_ERROR_OF_MEAN|0.114||0.5385|TWO_SIDED|90.0|-0.198|0.176|||Mixed Models Analysis|||Difference from placebo at Week 12||0.176|-0.198|0.5385
70937220|NCT01276509|141374368|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.124|STANDARD_ERROR_OF_MEAN|0.107||0.1234|TWO_SIDED|90.0|-0.052|0.299|||Mixed Models Analysis|||Difference from placebo at week 8||0.299|-0.052|0.1234
70937221|NCT01276509|141374368|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.071|STANDARD_ERROR_OF_MEAN|0.099||0.2378|TWO_SIDED|90.0|-0.092|0.234|||Mixed Models Analysis|||Difference from placebo at week 8||0.234|-0.092|0.2378
70937222|NCT01276509|141374368|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.102|STANDARD_ERROR_OF_MEAN|0.1||0.1529|TWO_SIDED|90.0|-0.062|0.266|||Mixed Models Analysis|||Difference from placebo at week 8||0.266|-0.062|0.1529
71063033|NCT03349060|141634554|SUPERIORITY||Difference in LS mean|-2.8||||0.0075|TWO_SIDED|95.0|-4.8|-0.7|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.7|-4.8|0.0075
71063034|NCT03349060|141634554|SUPERIORITY||Difference in LS mean|-5.3|||<|0.0001|TWO_SIDED|95.0|-7.4|-3.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-3.3|-7.4|<0.0001
71063035|NCT03349060|141634554|SUPERIORITY||Difference in LS mean|-2.8||||0.0072|TWO_SIDED|95.0|-4.8|-0.8|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.8|-4.8|0.0072
71063036|NCT03349060|141634554|SUPERIORITY||Difference in LS mean|-4.9|||<|0.0001|TWO_SIDED|95.0|-6.9|-2.9|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-2.9|-6.9|<0.0001
71063037|NCT03349060|141634555|SUPERIORITY||Difference in LS mean|-1.3||||0.275|TWO_SIDED|95.0|-3.5|1.0|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||1.0|-3.5|0.2750
71063038|NCT03349060|141634555|SUPERIORITY||Difference in LS mean|-2.5||||0.028|TWO_SIDED|95.0|-4.8|-0.3|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.3|-4.8|0.0280
71110708|NCT01415583|141726979|NON_INFERIORITY|Consistent with the noninferiority design, the null hypothesis states that the bleeding rate in patients receiving perioperative dexamethasone differed from the bleeding rate in patients receiving perioperative placebo; the alternative hypothesis states that the bleeding rate with dexamethasone is not greater than placebo by more than the noninferiority margin.||||||0.05|||||||t-test, 1 sided|||||||0.05
71063039|NCT03349060|141634555|SUPERIORITY||Difference in LS mean|-3.5||||0.0051|TWO_SIDED|95.0|-5.9|-1.1|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.1|-5.9|0.0051
71063040|NCT03349060|141634555|SUPERIORITY||Difference in LS mean|-6.4|||<|0.0001|TWO_SIDED|95.0|-8.8|-4.0|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-4.0|-8.8|<0.0001
71063041|NCT03349060|141634555|SUPERIORITY||Difference in LS mean|-2.1||||0.1706|TWO_SIDED|95.0|-5.1|0.9|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.9|-5.1|0.1706
71063042|NCT03349060|141634555|SUPERIORITY||Difference in LS mean|-4.4||||0.0048|TWO_SIDED|95.0|-7.4|-1.4|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.4|-7.4|0.0048
71063043|NCT03349060|141634555|SUPERIORITY||Difference in LS mean|-2.5||||0.0629|TWO_SIDED|95.0|-5.2|0.1|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.1|-5.2|0.0629
71063044|NCT03349060|141634555|SUPERIORITY||Difference in LS mean|-3.6||||0.01|TWO_SIDED|95.0|-6.2|-0.9|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.9|-6.2|0.0100
71110709|NCT01415583|141726979|NON_INFERIORITY|This noninferiority margin was set at 5%, meaning a difference in bleeding rates that did not exceed 5% would be taken as evidence that the bleeding with dexamethasone is not greater than that with placebo by more than 5%.||||||0.05|||||||t-test, 1 sided|||||||0.05
70937223|NCT01276509|141374368|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.038|STANDARD_ERROR_OF_MEAN|0.112||0.3661|TWO_SIDED|90.0|-0.146|0.222|||Mixed Models Analysis|||Difference from placebo at week 12||0.222|-0.146|0.3661
71063045|NCT03349060|141634556|SUPERIORITY||Difference in Percentage|6.6||||0.1238|TWO_SIDED|95.0|-0.7|13.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||13.9|-0.7|0.1238
71063046|NCT03349060|141634556|SUPERIORITY||Difference in Percentage|20.1||||0.0008|TWO_SIDED|95.0|11.0|29.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||29.2|11.0|0.0008
71063047|NCT03349060|141634556|SUPERIORITY||Difference in Percentage|6.8||||0.2091|TWO_SIDED|95.0|-2.8|16.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||16.4|-2.8|0.2091
71063048|NCT03349060|141634556|SUPERIORITY||Difference in Percentage|24.0||||0.0005|TWO_SIDED|95.0|12.9|35.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.0|12.9|0.0005
71063049|NCT03349060|141634556|SUPERIORITY||Difference in Percentage|9.1||||0.1161|TWO_SIDED|95.0|-0.9|19.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||19.1|-0.9|0.1161
71063050|NCT03349060|141634556|SUPERIORITY||Difference in Percentage|26.5||||0.0002|TWO_SIDED|95.0|15.3|37.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||37.7|15.3|0.0002
71063051|NCT03349060|141634556|SUPERIORITY||Difference in Percentage|8.1||||0.1837|TWO_SIDED|95.0|-2.8|19.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||19.1|-2.8|0.1837
71063052|NCT03349060|141634556|SUPERIORITY||Difference in Percentage|19.8||||0.0046|TWO_SIDED|95.0|8.1|31.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||31.6|8.1|0.0046
71063053|NCT03349060|141634557|SUPERIORITY||Difference in Percentage|3.2||||0.4795|TWO_SIDED|95.0|-10.3|16.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||16.6|-10.3|0.4795
71110710|NCT00552071|141726985|OTHER|||||||0.4||||||A two-sided p value of \<0.05 was considered significant.|t-test, 2 sided|||||||0.40
71110711|NCT00552071|141726986|OTHER|||||||0.43||||||A two-sided p value of \<0.05 was considered significant.|t-test, 2 sided|||||||0.43
71063054|NCT03349060|141634557|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-12.7|12.7||P-value could not be calculated since percentage of participants with events was 0.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||12.7|-12.7|
71063055|NCT03349060|141634557|SUPERIORITY||Difference in Percentage|13.3||||0.1452|TWO_SIDED|95.0|-3.6|30.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||30.3|-3.6|0.1452
71063056|NCT03349060|141634557|SUPERIORITY||Difference in Percentage|9.7||||0.2232|TWO_SIDED|95.0|-6.1|25.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||25.4|-6.1|0.2232
71063057|NCT03349060|141634557|SUPERIORITY||Difference in Percentage|5.8||||0.5707|TWO_SIDED|95.0|-13.7|25.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||25.4|-13.7|0.5707
71063058|NCT03349060|141634557|SUPERIORITY||Difference in Percentage|5.8||||0.5777|TWO_SIDED|95.0|-13.6|25.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||25.1|-13.6|0.5777
71063059|NCT03349060|141634557|SUPERIORITY||Difference in Percentage|19.3||||0.0744|TWO_SIDED|95.0|1.0|37.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||37.5|1.0|0.0744
71063060|NCT03349060|141634557|SUPERIORITY||Difference in Percentage|9.7||||0.2232|TWO_SIDED|95.0|-6.1|25.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||25.4|-6.1|0.2232
71063061|NCT03349060|141634558|SUPERIORITY||Difference in Percentage|31.6|||<|0.0001|TWO_SIDED|95.0|17.2|46.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||46.0|17.2|<0.0001
71063062|NCT03349060|141634558|SUPERIORITY||Difference in Percentage|35.7|||<|0.0001|TWO_SIDED|95.0|21.5|49.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||49.9|21.5|<0.0001
71063063|NCT03349060|141634558|SUPERIORITY||Difference in Percentage|20.4||||0.009|TWO_SIDED|95.0|5.2|35.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.6|5.2|0.0090
71063064|NCT03349060|141634558|SUPERIORITY||Difference in Percentage|33.3|||<|0.0001|TWO_SIDED|95.0|19.0|47.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||47.7|19.0|<0.0001
71063065|NCT03349060|141634558|SUPERIORITY||Difference in Percentage|16.5||||0.0421|TWO_SIDED|95.0|0.6|32.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||32.4|0.6|0.0421
71063066|NCT03349060|141634558|SUPERIORITY||Difference in Percentage|33.8|||<|0.0001|TWO_SIDED|95.0|18.9|48.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||48.8|18.9|<0.0001
71063067|NCT03349060|141634558|SUPERIORITY||Difference in Percentage|23.5||||0.0035|TWO_SIDED|95.0|8.2|38.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.8|8.2|0.0035
71063068|NCT03349060|141634558|SUPERIORITY||Difference in Percentage|28.8||||0.0002|TWO_SIDED|95.0|13.8|43.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||43.9|13.8|0.0002
71063069|NCT03349060|141634559|SUPERIORITY||Difference in Percentage|17.1||||0.2497|TWO_SIDED|95.0|-9.1|43.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||43.2|-9.1|0.2497
71063070|NCT03349060|141634559|SUPERIORITY||Difference in Percentage|17.1||||0.2371|TWO_SIDED|95.0|-9.0|43.3|||Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||43.3|-9.0|0.2371
71110712|NCT00532129|141727001|SUPERIORITY_OR_OTHER||||||=|0.029|TWO_SIDED||||||t-test, 2 sided|||CFB in GHS/QoL statistical analysis at Cycle 5.||||=0.029
70937224|NCT01276509|141374368|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.055|STANDARD_ERROR_OF_MEAN|0.116||0.3169|TWO_SIDED|90.0|-0.136|0.246|||Mixed Models Analysis|||Difference from placebo at week 12||0.246|-0.136|0.3169
70937225|NCT01276509|141374368|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.066|STANDARD_ERROR_OF_MEAN|0.111||0.2755|TWO_SIDED|90.0|-0.116|0.248|||Mixed Models Analysis|||Difference from placebo at week 12||0.248|-0.116|0.2755
70937226|NCT03854734|141374382|SUPERIORITY|Generalized estimating equations (GEE) model using the framework of a log-binomial logistic regression model.|Risk Ratio (RR)|1.12|||||TWO_SIDED|95.0|1.0|1.25|||Regression, Logistic|||Analysis for vaccine intention of Tdap||1.25|1.00|
70937227|NCT03854734|141374382|SUPERIORITY|Generalized estimating equations (GEE) model using the framework of a log-binomial logistic regression model.|Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|1.0|1.29|||Regression, Logistic|||Analysis for vaccine intention of MCV||1.29|1.00|
70937228|NCT03854734|141374382|SUPERIORITY|Generalized estimating equations (GEE) model using the framework of a log-binomial logistic regression model.|Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.96|1.14|||Regression, Logistic|||Analysis for vaccine intention of HPV||1.14|0.96|
70937229|NCT00805792|141374409|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Regression, Linear|||The statistical significance of the change was assessed by the P value associated with estimated regression coefficient (beta coefficient or slope).||||<.001
70937230|NCT00805792|141374410|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Regression, Linear|||The statistical significance of the change was assessed by the P value associated with estimated regression coefficient (beta coefficient or slope).||||<.001
70937231|NCT00805792|141374411|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Regression, Linear|||The statistical significance of the change was assessed by the P value associated with estimated regression coefficient (beta coefficient or slope).||||<.001
70937232|NCT04471805|141374422|SUPERIORITY||||||<|0.05||||||Post hoc analyses (paired t-tests and Bonferroni correction) and effect size (Cohen's d) were calculated to clarify significant main effects and interactions.|ANOVA|Normality and sphericity evaluated with Shapiro-Wilk test and Mauchly's test. Greenhouse-Geisser corrections used when sphericity was violated.||||||<0.05
70937233|NCT04471805|141374423|SUPERIORITY||||||<|0.05||||||Post hoc analyses (paired t-tests and Bonferroni correction) and effect size (Cohen's d) were calculated to clarify significant main effects and interactions.|ANOVA|Normality and sphericity evaluated with Shapiro-Wilk test and Mauchly's test. Greenhouse-Geisser corrections used when sphericity was violated.||||||<0.05
70937234|NCT01163214|141374425|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||t-test, 2 sided|||||||0.78
70937235|NCT01163214|141374425|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.58
70937236|NCT01163214|141374426|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||t-test, 2 sided|||||||0.76
70937237|NCT01163214|141374426|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.59
70937238|NCT01163214|141374427|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Comparison of arms for intraoperative narcotic use.||||<0.001
70937239|NCT01163214|141374427|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Comparison of arms for narcotic use on day of surgery as needed.||||<0.001
70937240|NCT01163214|141374427|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||t-test, 2 sided|||Comparison of arms for narcotic use on post operative day 1 as needed.||||0.17
71063071|NCT03349060|141634559|SUPERIORITY||Difference in Percentage|28.8||||0.0697|TWO_SIDED|95.0|-0.8|58.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||58.3|-0.8|0.0697
70937241|NCT01163214|141374427|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||t-test, 2 sided|||Comparison of arms for narcotic use on post operative day 2 as needed.||||0.51
70937242|NCT01163214|141374428|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for postoperative day 1 morning.||||<0.001
70937243|NCT01163214|141374428|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for postoperative day 1 afternoon.||||<0.001
70937244|NCT01163214|141374428|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for postoperative day 2 morning.||||0.002
70937245|NCT01163214|141374428|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for postoperative day 2 afternoon.||||0.97
70937246|NCT01163214|141374429|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for length of stay in the hospital.||||0.02
70937247|NCT01163214|141374430|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for femoral nerve.||||0.49
70937248|NCT01163214|141374430|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for common peroneal nerve.||||0.01
70937249|NCT01163214|141374430|SUPERIORITY_OR_OTHER|||||||0.62|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for tibial nerve.||||0.62
70937250|NCT01163214|141374430|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for femoral, peroneal, or tibial nerves.||||0.009
70937251|NCT01393964|141374431|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|104.096||||0.704|TWO_SIDED|90.0|86.983|124.576|||ANOVA|||The reference arm is NRF participants.||124.576|86.983|0.704
70937252|NCT01393964|141374431|SUPERIORITY_OR_OTHER||ratio of adjusted means|100.454||||0.965|TWO_SIDED|90.0|84.453|119.488|||ANOVA|||The reference arm is NRF participants.||119.488|84.453|0.965
70937253|NCT01393964|141374432|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|126.596||||0.164|TWO_SIDED|90.0|95.52|167.783|||ANOVA|||AUC(0-T). The reference arm is NRF participants.||167.783|95.52|0.164
70937254|NCT01393964|141374432|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|116.123||||0.355|TWO_SIDED|90.0|88.458|152.439|||ANOVA|||AUC(0-T). The reference arm is NRF participants.||152.439|88.458|0.355
71063072|NCT03349060|141634559|SUPERIORITY||Difference in Percentage|43.9||||0.003|TWO_SIDED|95.0|16.2|71.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||71.7|16.2|0.0030
71110713|NCT00532129|141727001|SUPERIORITY_OR_OTHER||||||=|0.027|TWO_SIDED||||||t-test, 2 sided|||CFB in GHS/QoL statistical analysis at Cycle 11.||||=0.027
71063073|NCT03349060|141634559|SUPERIORITY||Difference in Percentage|31.0||||0.0583|TWO_SIDED|95.0|2.0|59.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||59.9|2.0|0.0583
71063074|NCT03349060|141634559|SUPERIORITY||Difference in Percentage|41.2||||0.0085|TWO_SIDED|95.0|13.2|69.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||69.1|13.2|0.0085
71063075|NCT03349060|141634559|SUPERIORITY||Difference in Percentage|19.3||||0.1948|TWO_SIDED|95.0|-9.8|48.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||48.5|-9.8|0.1948
71063076|NCT03349060|141634559|SUPERIORITY||Difference in Percentage|30.6||||0.0296|TWO_SIDED|95.0|2.8|58.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||58.5|2.8|0.0296
71063077|NCT03349060|141634560|SUPERIORITY||Difference in LS mean|-0.5||||0.1718|TWO_SIDED|95.0|-1.1|0.2|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.2|-1.1|0.1718
71063078|NCT03349060|141634560|SUPERIORITY||Difference in LS mean|-1.1||||0.0018|TWO_SIDED|95.0|-1.7|-0.4|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.4|-1.7|0.0018
71063079|NCT03349060|141634560|SUPERIORITY||Difference in LS mean|-1.3||||0.0005|TWO_SIDED|95.0|-2.0|-0.6|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-2.0|0.0005
71063080|NCT03349060|141634560|SUPERIORITY||Difference in LS mean|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.1|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.1|-2.5|<0.0001
71063081|NCT03349060|141634560|SUPERIORITY||Difference in LS mean|-0.7||||0.0476|TWO_SIDED|95.0|-1.5|0.0|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.0|-1.5|0.0476
71063082|NCT03349060|141634560|SUPERIORITY||Difference in LS mean|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.4|-1.0|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.0|-2.4|<0.0001
71063083|NCT03349060|141634560|SUPERIORITY||Difference in LS mean|-1.1||||0.0028|TWO_SIDED|95.0|-1.9|-0.4|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.4|-1.9|0.0028
71063084|NCT03349060|141634560|SUPERIORITY||Difference in LS mean|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.3|-0.9|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.9|-2.3|<0.0001
71063085|NCT03349060|141634561|SUPERIORITY||Difference in LS mean|-0.2||||0.6134|TWO_SIDED|95.0|-0.9|0.5|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.5|-0.9|0.6134
71063086|NCT03349060|141634561|SUPERIORITY||Difference in LS mean|-0.7||||0.0422|TWO_SIDED|95.0|-1.4|0.0|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.0|-1.4|0.0422
71063087|NCT03349060|141634561|SUPERIORITY||Difference in LS mean|-0.5||||0.205|TWO_SIDED|95.0|-1.2|0.3|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.3|-1.2|0.2050
71063088|NCT03349060|141634561|SUPERIORITY||Difference in LS mean|-1.2||||0.0012|TWO_SIDED|95.0|-1.9|-0.5|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.5|-1.9|0.0012
71063089|NCT03349060|141634561|SUPERIORITY||Difference in LS mean|-0.4||||0.2657|TWO_SIDED|95.0|-1.2|0.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.3|-1.2|0.2657
71063090|NCT03349060|141634561|SUPERIORITY||Difference in LS mean|-1.2||||0.0019|TWO_SIDED|95.0|-2.0|-0.5|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.5|-2.0|0.0019
71063091|NCT03349060|141634561|SUPERIORITY||Difference in LS mean|-0.5||||0.1675|TWO_SIDED|95.0|-1.3|0.2|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.2|-1.3|0.1675
71063092|NCT03349060|141634561|SUPERIORITY||Difference in LS mean|-1.0||||0.0085|TWO_SIDED|95.0|-1.8|-0.3|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.3|-1.8|0.0085
71063093|NCT03349060|141634562|SUPERIORITY||Difference in Percentage|8.8||||0.5539|TWO_SIDED|95.0|-19.6|37.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||37.2|-19.6|0.5539
71063094|NCT03349060|141634562|SUPERIORITY||Difference in Percentage|27.9||||0.0561|TWO_SIDED|95.0|0.8|55.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||55.1|0.8|0.0561
71063095|NCT03349060|141634562|SUPERIORITY||Difference in Percentage|-4.9||||0.746|TWO_SIDED|95.0|-33.4|23.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.7|-33.4|0.7460
71110714|NCT00532129|141727001|SUPERIORITY_OR_OTHER||||||=|0.602|TWO_SIDED||||||t-test, 2 sided|||CFB in GHS/QoL statistical analysis at end of FU.||||=0.602
71110715|NCT00532129|141727001|SUPERIORITY_OR_OTHER||||||=|0.631|TWO_SIDED||||||t-test, 2 sided|||CFB in physical functioning statistical analysis at Cycle 5.||||=0.631
71110716|NCT00532129|141727001|SUPERIORITY_OR_OTHER||||||=|0.339|TWO_SIDED||||||t-test, 2 sided|||CFB in physical functioning statistical analysis at Cycle 11.||||=0.339
71110717|NCT00532129|141727001|SUPERIORITY_OR_OTHER||||||=|0.44|TWO_SIDED||||||t-test, 2 sided|||CFB in physical functioning statistical analysis at end of FU.||||=0.440
71110718|NCT00532129|141727001|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||t-test, 2 sided|||CFB in role functioning statistical analysis at Cycle 5.||||=1.000
71110719|NCT00532129|141727001|SUPERIORITY_OR_OTHER||||||=|0.465|TWO_SIDED||||||t-test, 2 sided|||CFB in role functioning statistical analysis at Cycle 11.||||=0.465
71110720|NCT00532129|141727001|SUPERIORITY_OR_OTHER||||||=|0.431|TWO_SIDED||||||t-test, 2 sided|||CFB in role functioning statistical analysis at end of FU.||||=0.431
71110721|NCT00532129|141727001|SUPERIORITY_OR_OTHER||||||=|0.65|TWO_SIDED||||||t-test, 2 sided|||CFB in emotional functioning statistical analysis at Cycle 5.||||=0.650
71110722|NCT00532129|141727001|SUPERIORITY_OR_OTHER||||||=|0.98|TWO_SIDED||||||t-test, 2 sided|||CFB in emotional functioning statistical analysis at Cycle 11.||||=0.980
71110723|NCT00532129|141727001|SUPERIORITY_OR_OTHER||||||=|0.906|TWO_SIDED||||||t-test, 2 sided|||CFB in emotional functioning statistical analysis at end of FU.||||=0.906
71110724|NCT00532129|141727001|SUPERIORITY_OR_OTHER||||||=|0.381|TWO_SIDED||||||t-test, 2 sided|||CFB in cognitive functioning statistical analysis at Cycle 5.||||=0.381
71110725|NCT00532129|141727001|SUPERIORITY_OR_OTHER||||||=|0.886|TWO_SIDED||||||t-test, 2 sided|||CFB in cognitive functioning statistical analysis at Cycle 11.||||=0.886
71110726|NCT00532129|141727001|SUPERIORITY_OR_OTHER||||||=|0.264|TWO_SIDED||||||t-test, 2 sided|||CFB in cognitive functioning statistical analysis at end of FU.||||=0.264
71110727|NCT00532129|141727001|SUPERIORITY_OR_OTHER||||||=|0.424|TWO_SIDED||||||t-test, 2 sided|||CFB in social functioning statistical analysis at Cycle 5.||||=0.424
71110728|NCT00532129|141727001|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||t-test, 2 sided|||CFB in social functioning statistical analysis at Cycle 11.||||=1.000
71110729|NCT00532129|141727001|SUPERIORITY_OR_OTHER||||||=|0.312|TWO_SIDED||||||t-test, 2 sided|||CFB in social functioning statistical analysis at end of FU.||||=0.312
71110730|NCT00532129|141727001|SUPERIORITY_OR_OTHER||||||=|0.664|TWO_SIDED||||||t-test, 2 sided|||CFB in fatigue statistical analysis at Cycle 5.||||=0.664
71110731|NCT00532129|141727001|SUPERIORITY_OR_OTHER||||||=|0.17|TWO_SIDED||||||t-test, 2 sided|||CFB in fatigue functioning statistical analysis at Cycle 11.||||=0.170
71110732|NCT00532129|141727001|SUPERIORITY_OR_OTHER||||||=|0.318|TWO_SIDED||||||t-test, 2 sided|||CFB in fatigue statistical analysis at end of FU.||||=0.318
71110733|NCT00532129|141727001|SUPERIORITY_OR_OTHER||||||=|0.536|TWO_SIDED||||||t-test, 2 sided|||CFB in Nausea/vomiting statistical analysis at Cycle 5.||||=0.536
71110734|NCT00532129|141727001|SUPERIORITY_OR_OTHER||||||=|0.9|TWO_SIDED||||||t-test, 2 sided|||CFB in nausea/vomiting statistical analysis at Cycle 11.||||=0.900
71110735|NCT00532129|141727001|SUPERIORITY_OR_OTHER||||||=|0.188|TWO_SIDED||||||t-test, 2 sided|||CFB in nausea/vomiting statistical analysis at end of FU.||||=0.188
71110736|NCT00532129|141727001|SUPERIORITY_OR_OTHER||||||=|0.37|TWO_SIDED||||||t-test, 2 sided|||CFB in pain statistical analysis at Cycle 5.||||=0.370
71110737|NCT00532129|141727001|SUPERIORITY_OR_OTHER||||||=|0.813|TWO_SIDED||||||t-test, 2 sided|||CFB in pain statistical analysis at Cycle 11.||||=0.813
71110738|NCT00532129|141727001|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||t-test, 2 sided|||CFB in pain statistical analysis at end of FU.||||=1.000
71110739|NCT03427814|141727015|SUPERIORITY||||||=|0.1428|||||||Log Rank|The one-sided p-value was based on a stratified log-rank test.||||||= 0.1428
71110740|NCT03846427|141727028|SUPERIORITY|P value was based on the exact binomial test against the null hypothesis of ORR = 30% with alternative of ORR \> 30%|||||<|0.0001|||||||Binomial exact method|||||||<0.0001
71110741|NCT01693250|141727054|SUPERIORITY||Mean Difference (Final Values)|1.68|STANDARD_DEVIATION|0.5|<|0.001|TWO_SIDED|95.0|||||Mixed Models Analysis|||This is a feasibility and pilot study. We acknowledge that our sample size will not have adequate power to detect any statistically significant outcomes. We chose a sample size that would be large enough to assess feasibility and effect size and to accommodate recruitment within the study time and budget of this application. We hope to be able to estimate the effect size of the intervention.||||<.001
71110742|NCT01693250|141727055|SUPERIORITY||Mean Difference (Final Values)|2.66||||0.001|TWO_SIDED|95.0|||||Mixed Models Analysis|||We hypothesized the intervention group will have significant reduction of systematic blood pressure compared to the control group at 6 month follow up.||||.001
71110743|NCT04971967|141727088|SUPERIORITY|||||||0.07|||||||Generalized linear regression|||||||0.07
71110744|NCT04971967|141727089|SUPERIORITY|||||||0.3|||||||Generalized linear regression|||||||0.30
70937255|NCT01393964|141374432|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|129.858||||0.228|TWO_SIDED|90.0|90.366|186.609|||ANOVA|||AUC (INF). The reference arm is NRF participants.||186.609|90.366|0.228
70937256|NCT01393964|141374432|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|110.4||||0.642|TWO_SIDED|90.0|76.825|158.647|||ANOVA|||AUC(INF). The reference arm is NRF participants.||158.647|76.825|0.642
70937257|NCT04405180|141374442|SUPERIORITY||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|4.0||0.9017|TWO_SIDED|||||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data|ANCOVA|||||||0.9017
70937258|NCT04405180|141374443|SUPERIORITY||Mean Difference (Net)|0.0342|STANDARD_ERROR_OF_MEAN|0.0417||0.4215|TWO_SIDED||||||ANCOVA|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.4215
70937259|NCT04405180|141374444|SUPERIORITY||Mean Difference (Net)|6.0|STANDARD_ERROR_OF_MEAN|53.0||0.9024|TWO_SIDED||||||ANCOVA|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||.9024
70937260|NCT04405180|141374445|SUPERIORITY||Mean Difference (Net)|-59.0|STANDARD_ERROR_OF_MEAN|42.0||0.1646|TWO_SIDED||||||Mixed Models Analysis|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.1646
70937261|NCT04405180|141374446|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|1.2||0.9814|TWO_SIDED||||||ANCOVA|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.9814
70937262|NCT04405180|141374447|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.6217|TWO_SIDED||||||Mixed Models Analysis|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.6217
71063096|NCT03349060|141634562|SUPERIORITY||Difference in Percentage|0.0||||1|TWO_SIDED|95.0|-28.3|28.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||28.3|-28.3|1.0000
71063097|NCT03349060|141634562|SUPERIORITY||Difference in Percentage|20.8||||0.1474|TWO_SIDED|95.0|-4.5|46.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||46.2|-4.5|0.1474
71063098|NCT03349060|141634562|SUPERIORITY||Difference in Percentage|37.3||||0.0123|TWO_SIDED|95.0|12.1|62.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||62.5|12.1|0.0123
70852562|NCT02522624|141194052|SUPERIORITY_OR_OTHER|||||||0.002||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Linear|||||||0.002
70937263|NCT04405180|141374448|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.7981|TWO_SIDED||||||Mixed Models Analysis|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.7981
70937264|NCT04405180|141374449|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.4||0.6677|TWO_SIDED||||||Mixed Models Analysis|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.6677
70937265|NCT04405180|141374450|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|1.1||0.3745|TWO_SIDED||||||Mixed Models Analysis|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.3745
70937266|NCT04405180|141374451|SUPERIORITY||Mean Difference (Net)|243.0|STANDARD_ERROR_OF_MEAN|400.0||0.5496|TWO_SIDED||||||ANCOVA|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.5496
70852563|NCT02522624|141194052|SUPERIORITY_OR_OTHER|||||||0.3|||||||Regression, Linear|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).||||0.30
70852564|NCT02522624|141194052|SUPERIORITY_OR_OTHER|||||||0.82|||||||Regression, Linear|||Controlling for Numeracy.||||0.82
70937267|NCT03879538|141374452|SUPERIORITY||Mean Difference (Net)|-0.57||||0.19|TWO_SIDED|95.0|-1.42|0.28||a priori threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Mean difference is Nitrous Oxide minus Control.|Null hypothesis: Mean of pain score assessed at one-week and one-month follow-up after end of treatment for Nitrous Oxide group equals that assessed at same time points for the Control group.||0.28|-1.42|0.19
70937268|NCT03879538|141374453|SUPERIORITY||Mean Difference (Net)|0.13||||0.36|TWO_SIDED|95.0|-0.16|0.43||a priori threshold for statistical significance is p\<0.05.|Mixed Models Analysis||Mean difference is Nitrous oxide minus control.|Null hypothesis for testing difference in means of physical health Z-score between two study groups: mean of physical health Z-score assessed at one-week and one-month follow-ups for Nitrous Oxide group was equal to that assessed at the same follow-up time points for Control group.||0.43|-0.16|0.36
70941752|NCT04748445|141383935|OTHER||Slope|-1.368|STANDARD_ERROR_OF_MEAN|9.117||0.881|TWO_SIDED|90.0|-1.648|1.374|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 02 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and lower limit it was 10\^-3. For estimated value and dispersion value it was 10\^-4).||1.374|-1.648|0.8810
71063099|NCT03349060|141634562|SUPERIORITY||Difference in Percentage|-0.4||||0.976|TWO_SIDED|95.0|-28.5|27.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||27.6|-28.5|0.9760
71063100|NCT03349060|141634562|SUPERIORITY||Difference in Percentage|7.8||||0.5965|TWO_SIDED|95.0|-20.4|36.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||36.1|-20.4|0.5965
71063101|NCT03349060|141634563|SUPERIORITY||Difference in Percentage|24.0||||0.2278|TWO_SIDED|95.0|-9.9|58.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||58.0|-9.9|0.2278
71063102|NCT03349060|141634563|SUPERIORITY||Difference in Percentage|35.2||||0.0996|TWO_SIDED|95.0|-2.0|72.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||72.4|-2.0|0.0996
71063103|NCT03349060|141634563|SUPERIORITY||Difference in Percentage|14.5||||0.4449|TWO_SIDED|95.0|-21.6|50.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||50.6|-21.6|0.4449
71063104|NCT03349060|141634563|SUPERIORITY||Difference in Percentage|16.9||||0.4139|TWO_SIDED|95.0|-21.6|55.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||55.5|-21.6|0.4139
71063105|NCT03349060|141634563|SUPERIORITY||Difference in Percentage|-6.7||||0.729|TWO_SIDED|95.0|-40.7|27.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||27.4|-40.7|0.7290
71063106|NCT03349060|141634563|SUPERIORITY||Difference in Percentage|8.7||||0.6585|TWO_SIDED|95.0|-27.3|44.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||44.6|-27.3|0.6585
71063107|NCT03349060|141634563|SUPERIORITY||Difference in Percentage|18.2||||0.3638|TWO_SIDED|95.0|-18.7|55.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||55.1|-18.7|0.3638
71063108|NCT03349060|141634563|SUPERIORITY||Difference in Percentage|40.5||||0.055|TWO_SIDED|95.0|2.4|78.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||78.5|2.4|0.0550
71063109|NCT03349060|141634564|SUPERIORITY||Difference in Percentage|-18.8||||0.4036|TWO_SIDED|95.0|-58.4|20.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||20.9|-58.4|0.4036
71063110|NCT03349060|141634564|SUPERIORITY||Difference in Percentage|-35.3||||0.158|TWO_SIDED|95.0|-75.9|5.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.3|-75.9|0.1580
71063111|NCT03349060|141634564|SUPERIORITY||Difference in Percentage|-14.2||||0.514|TWO_SIDED|95.0|-53.5|25.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||25.1|-53.5|0.5140
71063112|NCT03349060|141634564|SUPERIORITY||Difference in Percentage|-19.8||||0.4149|TWO_SIDED|95.0|-63.3|23.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.7|-63.3|0.4149
71063113|NCT03349060|141634564|SUPERIORITY||Difference in Percentage|-18.8||||0.4036|TWO_SIDED|95.0|-58.4|20.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||20.9|-58.4|0.4036
71063114|NCT03349060|141634564|SUPERIORITY||Difference in Percentage|-30.7||||0.2092|TWO_SIDED|95.0|-70.9|9.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.6|-70.9|0.2092
71063115|NCT03349060|141634564|SUPERIORITY||Difference in Percentage|11.9||||0.5982|TWO_SIDED|95.0|-29.1|53.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||53.0|-29.1|0.5982
71110745|NCT04971967|141727091|SUPERIORITY|||||||0.28|||||||Generalized linear regression|||||||0.28
71110746|NCT04971967|141727093|SUPERIORITY|||||||0.07|||||||Generalized linear regression|||||||0.07
71110747|NCT04971967|141727094|SUPERIORITY|||||||0.11|||||||Generalized linear regression|||||||0.11
71117647|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
71063116|NCT03349060|141634564|SUPERIORITY||Difference in Percentage|4.2||||0.8647|TWO_SIDED|95.0|-36.3|44.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||44.7|-36.3|0.8647
71063117|NCT03349060|141634565|SUPERIORITY||Difference in Percentage|-78.6||||0.0546|TWO_SIDED|95.0|-117.5|-39.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||-39.6|-117.5|0.0546
71063118|NCT03349060|141634565|SUPERIORITY||Difference in Percentage|-27.9||||0.3573|TWO_SIDED|95.0|-62.5|6.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.7|-62.5|0.3573
71063119|NCT03349060|141634565|SUPERIORITY||Difference in Percentage|-3.6||||0.9219|TWO_SIDED|95.0|-55.6|48.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||48.5|-55.6|0.9219
71063120|NCT03349060|141634565|SUPERIORITY||Difference in Percentage|24.6||||0.3173|TWO_SIDED|95.0|-14.4|63.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||63.6|-14.4|0.3173
71063121|NCT03349060|141634565|SUPERIORITY||Difference in Percentage|-25.0||||0.5408|TWO_SIDED|95.0|-77.0|27.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||27.0|-77.0|0.5408
71063122|NCT03349060|141634565|SUPERIORITY||Difference in Percentage|24.6||||0.3173|TWO_SIDED|95.0|-14.4|63.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||63.6|-14.4|0.3173
71063123|NCT03349060|141634565|SUPERIORITY||Difference in Percentage|-25.0||||0.5408|TWO_SIDED|95.0|-77.0|27.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||27.0|-77.0|0.5408
71063124|NCT03349060|141634565|SUPERIORITY||Difference in Percentage|24.6||||0.3173|TWO_SIDED|95.0|-14.4|63.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||63.6|-14.4|0.3173
71063125|NCT03349060|141634566|SUPERIORITY||Difference in LS mean|-2.8||||0.0006|TWO_SIDED|95.0|-4.4|-1.2|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.2|-4.4|0.0006
71110748|NCT04723355|141727156|NON_INFERIORITY|In the sample size calculations, we assumed that the innovative 3-lead wireless water resistant Holter System would have a concordance in the diagnosis of arrhythmia compared to the conventional Holter device similar to a previous study that compared a patch to the conventional Holter device. With this assumption, a total sample of 182 participants would have 80% power to demonstrate an accuracy of at least 85% with a significance level of 2.5% (the 95% CI lower limit should be above 85%).|Accuracy|0.87|||||TWO_SIDED|95.0|0.81|0.92||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||0.92|0.81|
71063126|NCT03349060|141634566|SUPERIORITY||Difference in LS mean|-6.3|||<|0.0001|TWO_SIDED|95.0|-7.9|-4.7|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-4.7|-7.9|<0.0001
71063127|NCT03349060|141634566|SUPERIORITY||Difference in LS mean|-3.8|||<|0.0001|TWO_SIDED|95.0|-5.6|-2.0|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-2.0|-5.6|<0.0001
71063128|NCT03349060|141634566|SUPERIORITY||Difference in LS mean|-8.4|||<|0.0001|TWO_SIDED|95.0|-10.2|-6.6|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-6.6|-10.2|<0.0001
71063129|NCT03349060|141634566|SUPERIORITY||Difference in LS mean|-2.7||||0.0096|TWO_SIDED|95.0|-4.7|-0.7|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.7|-4.7|0.0096
71063130|NCT03349060|141634566|SUPERIORITY||Difference in LS mean|-7.2|||<|0.0001|TWO_SIDED|95.0|-9.3|-5.2|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-5.2|-9.3|<0.0001
71063131|NCT03349060|141634566|SUPERIORITY||Difference in LS mean|-3.1||||0.0049|TWO_SIDED|95.0|-5.2|-0.9|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.9|-5.2|0.0049
70937269|NCT03879538|141374453|SUPERIORITY||Mean Difference (Net)|0.087||||0.66|TWO_SIDED|95.0|-0.31|0.48||a priori threshold for statistical significance is p\<0.05.|Mixed Models Analysis||Mean difference is Nitrous oxide minus control.|Null hypothesis for testing difference in means of mental health Z-score between two study groups: mean of mental health Z-score assessed at one-week and one-month follow-ups for Nitrous Oxide group was equal to that assessed at the same follow-up time points for Control group.||0.48|-0.31|0.66
70937270|NCT03879538|141374454|SUPERIORITY||Mean Difference (Net)|-0.7||||0.23|TWO_SIDED|95.0|-1.85|0.46||a priori threshold for statistical significance is p = 0.05.|Mixed Models Analysis||Mean difference is Nitrous Oxide minus Control.|Null hypothesis: Mean of PGIC scale assessed at one-week and one-month follow-up time points for Nitrous Oxide patients is equal to that assessed at the same time points for Control patients.||0.46|-1.85|0.23
71063132|NCT03349060|141634566|SUPERIORITY||Difference in LS mean|-6.9|||<|0.0001|TWO_SIDED|95.0|-9.0|-4.7|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-4.7|-9.0|<0.0001
71063133|NCT03349060|141634567|SUPERIORITY||Difference in LS mean|-0.4||||0.002|TWO_SIDED|95.0|-0.6|-0.1|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.1|-0.6|0.0020
71063134|NCT03349060|141634567|SUPERIORITY||Difference in LS mean|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.6|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-1.0|<0.0001
71063135|NCT03349060|141634567|SUPERIORITY||Difference in LS mean|-0.5||||0.0011|TWO_SIDED|95.0|-0.7|-0.2|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.2|-0.7|0.0011
71063136|NCT03349060|141634567|SUPERIORITY||Difference in LS mean|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.7|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.7|-1.2|<0.0001
70937271|NCT03265132|141374470|SUPERIORITY||Risk Difference (RD)|1.0||||0.0022|TWO_SIDED|95.0|0.42|1.0|||Fisher Exact|||||1.00|0.42|0.0022
70937272|NCT00666705|141374533|SUPERIORITY_OR_OTHER||Ratio (percent)|85.76||||||90.0|79.89|92.07|||Mixed Models Analysis|Natural log transformed AUCτ was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.|Ratio (percent) (Test/Reference) of Adjusted Geometric Means|The alternate hypothesis of bioequivalence is that there is no difference between treatment groups. For maraviroc, a sample size of 18 subjects provided 99% power that the 90% confidence interval (CI) for the ratio of Test (raltegravir co-administered with maraviroc) to Reference (maraviroc administered alone) treatment for the area under the plasma concentration-time profile over the dosing interval (AUCτ) would lie within the acceptance region of (80%, 125%).||92.07|79.89|
70937273|NCT00666705|141374534|SUPERIORITY_OR_OTHER||Ratio (percent)|79.48||||||90.0|67.19|94.02|||Mixed Models Analysis|Natural log transformed Cmax was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.|Ratio (percent) (Test/Reference) of Adjusted Geometric Means|The alternate hypothesis of bioequivalence is that there is no difference between treatment groups. For maraviroc, a sample size of 18 subjects provided 91% power that the 90% CI for the ratio of Test (raltegravir co-administered with maraviroc) to Reference (maraviroc administered alone) treatment for the maximum concentration (Cmax) would lie within the acceptance region of (80%, 125%).||94.02|67.19|
71063137|NCT03349060|141634567|SUPERIORITY||Difference in LS mean|-0.5||||0.002|TWO_SIDED|95.0|-0.8|-0.2|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.2|-0.8|0.0020
71063138|NCT03349060|141634567|SUPERIORITY||Difference in LS mean|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.6|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-1.2|<0.0001
71110749|NCT04723355|141727156|OTHER||Sensitivity|0.9|||||TWO_SIDED|95.0|0.83|0.95||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.95|0.83|
71063139|NCT03349060|141634567|SUPERIORITY||Difference in LS mean|-0.5||||0.0014|TWO_SIDED|95.0|-0.8|-0.2|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.2|-0.8|0.0014
71063140|NCT03349060|141634567|SUPERIORITY||Difference in LS mean|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.6|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-1.3|<0.0001
71063141|NCT03349060|141634568|SUPERIORITY||Difference in Percentage|6.0||||0.0575|TWO_SIDED|95.0|0.3|11.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.7|0.3|0.0575
71063142|NCT03349060|141634568|SUPERIORITY||Difference in Percentage|18.1||||0.0002|TWO_SIDED|95.0|10.7|25.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||25.5|10.7|0.0002
71063143|NCT03349060|141634568|SUPERIORITY||Difference in Percentage|9.2||||0.0411|TWO_SIDED|95.0|1.3|17.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||17.1|1.3|0.0411
70937274|NCT00666705|141374535|SUPERIORITY_OR_OTHER||Ratio (percent)|63.25||||||90.0|44.27|90.39|||Mixed Models Analysis|Natural log transformed AUCτ was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.|Ratio (percent) (Test/Reference) of Adjusted Geometric Means|For raltegravir, a sample size of 18 subjects provided 90% CIs for the difference between treatments of raltegravir (±0.205) on the natural log scale for AUCτ, with 90% coverage probability.||90.39|44.27|
70937275|NCT00666705|141374536|SUPERIORITY_OR_OTHER||Ratio (percent)|90.33||||||90.0|85.28|95.68|||Mixed Models Analysis|Natural log transformed C12 was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.|Ratio (percent) (Test/Reference) of Adjusted Geometric Means|The alternate hypothesis of bioequivalence is that there is no difference between treatment groups.||95.68|85.28|
71063144|NCT03349060|141634568|SUPERIORITY||Difference in Percentage|26.2|||<|0.0001|TWO_SIDED|95.0|16.9|35.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.5|16.9|<0.0001
71063145|NCT03349060|141634568|SUPERIORITY||Difference in Percentage|8.9||||0.0781|TWO_SIDED|95.0|-0.1|18.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||18.0|-0.1|0.0781
70937276|NCT00666705|141374537|SUPERIORITY_OR_OTHER||Ratio (percent)|66.77||||||90.0|41.22|108.15|||Mixed Models Analysis|Natural log transformed Cmax was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.|Ratio (percent) (Test/Reference) of Adjusted Geometric Means|For raltegravir, a sample size of 18 subjects provided 90% CIs for the difference between treatments of raltegravir (±0.293) on the natural log scale for Cmax, with 90% coverage probability.||108.15|41.22|
70937277|NCT00666705|141374538|SUPERIORITY_OR_OTHER||ratio (percent)|72.42||||||90.0|57.82|90.71|||Mixed Models Analysis|Natural log transformed C12 was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.|Ratio (percent) (Test/Reference) of Adjusted Geometric Means|||90.71|57.82|
70937278|NCT01109979|141374539|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.04
70937279|NCT01228734|141374540|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.629|||<|0.001|TWO_SIDED|95.0|0.498|0.794|||Log Rank|||||0.794|0.498|<0.001
70937280|NCT02580799|141374553|SUPERIORITY_OR_OTHER||||||=|0.137|TWO_SIDED||||||Chi-squared|||Site A: Site B variability assessment||||=0.137
70937281|NCT02580799|141374553|SUPERIORITY_OR_OTHER||||||=|0.454|TWO_SIDED||||||Chi-squared|||Site A: Site C variability assessment||||=0.454
70937282|NCT02580799|141374553|SUPERIORITY_OR_OTHER||||||=|0.211|TWO_SIDED||||||Chi-squared|||Site A: Site D variability assessment||||=0.211
70937283|NCT02580799|141374553|SUPERIORITY_OR_OTHER||||||=|0.294|TWO_SIDED||||||Chi-squared|||Site A: Site E variability assessment||||=0.294
70937284|NCT02580799|141374555|SUPERIORITY_OR_OTHER||||||=|0.054|TWO_SIDED||||||Chi-squared|||Site B: Site C variability assessment||||=0.054
70937285|NCT02580799|141374555|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Chi-squared|||Site B: Site D variability assessment||||=1.000
70937286|NCT02580799|141374555|SUPERIORITY_OR_OTHER||||||=|0.968|TWO_SIDED||||||Chi-squared|||Site B: Site E variability assessment||||=0.968
70937287|NCT02580799|141374568|SUPERIORITY_OR_OTHER||||||=|0.246|TWO_SIDED||||||Chi-squared|||Site C: Site D variability assessment||||=0.246
70937288|NCT02580799|141374568|SUPERIORITY_OR_OTHER||||||=|0.032|TWO_SIDED||||||Chi-squared|||Site C: Site E variability assessment||||=0.032
70937289|NCT02580799|141374568|SUPERIORITY_OR_OTHER||||||=|0.007|TWO_SIDED||||||Chi-squared|||Site D: Site E variability assessment||||=0.007
71063146|NCT03349060|141634568|SUPERIORITY||Difference in Percentage|26.2|||<|0.0001|TWO_SIDED|95.0|16.2|36.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||36.3|16.2|<0.0001
71110750|NCT04723355|141727156|OTHER||Specificity|0.83|||||TWO_SIDED|95.0|0.72|0.9||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.90|0.72|
70937290|NCT02580799|141374570|SUPERIORITY_OR_OTHER||||||=|0.988|TWO_SIDED||||||Chi-squared|||Abroad: Site A variability assessment||||=0.988
70937291|NCT02580799|141374570|SUPERIORITY_OR_OTHER||||||=|0.008|TWO_SIDED||||||Chi-squared|||Abroad: Site B variability assessment||||=0.008
71110751|NCT04723355|141727156|OTHER||Positive predictive value|0.88|||||TWO_SIDED|95.0|0.8|0.93||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.93|0.80|
70937292|NCT02580799|141374570|SUPERIORITY_OR_OTHER||||||=|0.031|TWO_SIDED||||||Chi-squared|||Abroad: Site C variability assessment||||=0.031
70937293|NCT02580799|141374570|SUPERIORITY_OR_OTHER||||||=|0.554|TWO_SIDED||||||Chi-squared|||Abroad: Site D variability assessment||||=0.554
70937294|NCT02580799|141374570|SUPERIORITY_OR_OTHER||||||=|0.709|TWO_SIDED||||||Chi-squared|||Abroad: Site E variability assessment||||=0.709
70937295|NCT03456856|141374572|SUPERIORITY||least square mean difference|-4.5|STANDARD_ERROR_OF_MEAN|1.7||0.013|TWO_SIDED|95.0|-8.0|-1.0|||repeated measures linear model|||The estimated mean treatment difference (95% CI) takes into account a presumed -5 bpm change from baseline heart rate in the absence of ivabradine (as seen in the placebo group in the SHIFT study, (NCT02441218, PMID 20801500).||-1.0|-8.0|0.013
70937296|NCT02410278|141374598|SUPERIORITY||Odds Ratio (OR)|3.931||||0.0617|TWO_SIDED|95.0|0.938|20.832|||weighted logistic regression model|||Odds ratio is the odds of an event in the Montelukast treatment group divided by the odds of an event in the placebo treatment group. P-value is from the likelihood ratio test that the odds ratio is 1. CI = profile likelihood confidence interval.||20.832|0.938|0.0617
71063147|NCT03349060|141634568|SUPERIORITY||Difference in Percentage|14.2||||0.0075|TWO_SIDED|95.0|5.3|23.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.2|5.3|0.0075
70937297|NCT02410278|141374599|SUPERIORITY||adjusted mean difference|0.084||||0.3753|TWO_SIDED|95.0|-0.104|0.273|||ANCOVA|||Results are obtained from an ANCOVA model for comparing average change of the GSRS score in the two treatment groups, adjusted for age, weight and baseline GSRS score. Weights, defined as the proportions of days with GSRS score recorded during the Day 1 - Day 10 period are applied to adjust for missing data.||0.273|-0.104|0.3753
70937298|NCT02410278|141374600|SUPERIORITY||adjusted mean difference|0.081||||0.0376|TWO_SIDED|95.0|0.005|0.158|||Repeated measures model|||Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and Week 10.||0.158|0.005|0.0376
71063148|NCT03349060|141634568|SUPERIORITY||Difference in Percentage|29.3|||<|0.0001|TWO_SIDED|95.0|19.6|38.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.9|19.6|<0.0001
71063149|NCT03349060|141634569|SUPERIORITY||Difference in LS mean|0.034||||0.0453|TWO_SIDED|95.0|0.001|0.066|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.066|0.001|0.0453
71063150|NCT03349060|141634569|SUPERIORITY||Difference in LS mean|0.068|||<|0.0001|TWO_SIDED|95.0|0.036|0.101|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.101|0.036|<0.0001
71063151|NCT03349060|141634569|SUPERIORITY||Difference in LS mean|0.025||||0.1821|TWO_SIDED|95.0|-0.012|0.062|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.062|-0.012|0.1821
71063152|NCT03349060|141634569|SUPERIORITY||Difference in LS mean|0.055||||0.0038|TWO_SIDED|95.0|0.018|0.092|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.092|0.018|0.0038
71063153|NCT03349060|141634569|SUPERIORITY||Difference in LS mean|0.048||||0.0241|TWO_SIDED|95.0|0.006|0.09|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.090|0.006|0.0241
71063154|NCT03349060|141634569|SUPERIORITY||Difference in LS mean|0.093|||<|0.0001|TWO_SIDED|95.0|0.051|0.134|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.134|0.051|<0.0001
71063155|NCT03349060|141634569|SUPERIORITY||Difference in LS mean|0.044||||0.0461|TWO_SIDED|95.0|0.001|0.087|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.087|0.001|0.0461
71063156|NCT03349060|141634569|SUPERIORITY||Difference in LS mean|0.064||||0.0037|TWO_SIDED|95.0|0.021|0.107|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.107|0.021|0.0037
71063157|NCT03349060|141634570|SUPERIORITY||Difference in LS mean|4.548||||0.0319|TWO_SIDED|95.0|0.397|8.7|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||8.700|0.397|0.0319
71063158|NCT03349060|141634570|SUPERIORITY||Difference in LS mean|8.659|||<|0.0001|TWO_SIDED|95.0|4.496|12.822|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||12.822|4.496|<0.0001
71063159|NCT03349060|141634570|SUPERIORITY||Difference in LS mean|4.361||||0.0702|TWO_SIDED|95.0|-0.362|9.084|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||9.084|-0.362|0.0702
71063160|NCT03349060|141634570|SUPERIORITY||Difference in LS mean|10.085|||<|0.0001|TWO_SIDED|95.0|5.349|14.821|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||14.821|5.349|<0.0001
71063161|NCT03349060|141634570|SUPERIORITY||Difference in LS mean|6.045||||0.03|TWO_SIDED|95.0|0.589|11.501|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||11.501|0.589|0.0300
71063162|NCT03349060|141634570|SUPERIORITY||Difference in LS mean|9.803||||0.0005|TWO_SIDED|95.0|4.368|15.237|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||15.237|4.368|0.0005
71110752|NCT04723355|141727156|OTHER||Negative predictive value|0.86|||||TWO_SIDED|95.0|0.76|0.93||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.93|0.76|
70937299|NCT02410278|141374601|SUPERIORITY||Hazard Ratio (HR)|1.094||||0.7952|TWO_SIDED|95.0|0.554|2.164|||Regression, Cox|||Hazard ratio and the P-value are based on the Cox's proportional hazard regression model, adjusted for age, weight and baseline GSRS score. Hazard ratio (HR) is the ratio of hazard rates of Montelukast and placebo treatment groups. P-value is from the Wald test that HR is 1. CI = Wald confidence interval.||2.164|0.554|0.7952
71063163|NCT03349060|141634570|SUPERIORITY||Difference in LS mean|7.569||||0.0067|TWO_SIDED|95.0|2.119|13.019|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||13.019|2.119|0.0067
71063164|NCT03349060|141634570|SUPERIORITY||Difference in LS mean|9.374||||0.0008|TWO_SIDED|95.0|3.933|14.815|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||14.815|3.933|0.0008
71063165|NCT03349060|141634571|SUPERIORITY||Difference in LS mean|-0.004||||0.9568|TWO_SIDED|95.0|-0.137|0.13|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.130|-0.137|0.9568
71063166|NCT03349060|141634571|SUPERIORITY||Difference in LS mean|0.09||||0.1782|TWO_SIDED|95.0|-0.042|0.223|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.223|-0.042|0.1782
71063167|NCT03349060|141634571|SUPERIORITY||Difference in LS mean|0.174||||0.0491|TWO_SIDED|95.0|0.001|0.347|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.347|0.001|0.0491
71063168|NCT03349060|141634571|SUPERIORITY||Difference in LS mean|0.284||||0.0015|TWO_SIDED|95.0|0.112|0.456|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.456|0.112|0.0015
71063169|NCT03349060|141634571|SUPERIORITY||Difference in LS mean|0.004||||0.9638|TWO_SIDED|95.0|-0.185|0.194|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.194|-0.185|0.9638
71063170|NCT03349060|141634571|SUPERIORITY||Difference in LS mean|0.08||||0.4016|TWO_SIDED|95.0|-0.109|0.27|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.270|-0.109|0.4016
71063171|NCT03349060|141634571|SUPERIORITY||Difference in LS mean|0.007||||0.9429|TWO_SIDED|95.0|-0.184|0.198|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.198|-0.184|0.9429
71063172|NCT03349060|141634571|SUPERIORITY||Difference in LS mean|0.062||||0.5212|TWO_SIDED|95.0|-0.13|0.254|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.254|-0.130|0.5212
71063173|NCT03349060|141634572|SUPERIORITY||Difference in LS mean|2.131||||0.6467|TWO_SIDED|95.0|-7.095|11.358|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||11.358|-7.095|0.6467
71063174|NCT03349060|141634572|SUPERIORITY||Difference in LS mean|11.549||||0.0147|TWO_SIDED|95.0|2.338|20.761|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||20.761|2.338|0.0147
71063175|NCT03349060|141634572|SUPERIORITY||Difference in LS mean|6.853||||0.1894|TWO_SIDED|95.0|-3.453|17.159|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||17.159|-3.453|0.1894
71063176|NCT03349060|141634572|SUPERIORITY||Difference in LS mean|16.99||||0.0015|TWO_SIDED|95.0|6.699|27.281|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||27.281|6.699|0.0015
71063177|NCT03349060|141634572|SUPERIORITY||Difference in LS mean|8.672||||0.1267|TWO_SIDED|95.0|-2.518|19.862|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||19.862|-2.518|0.1267
71063178|NCT03349060|141634572|SUPERIORITY||Difference in LS mean|9.354||||0.1009|TWO_SIDED|95.0|-1.866|20.573|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||20.573|-1.866|0.1009
71110753|NCT04723355|141727156|OTHER||Cohen Kappa coefficient|0.74|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
71110754|NCT04723355|141727156|OTHER||Positive likelihood ratio|5.21|||||TWO_SIDED|95.0|3.17|8.58||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||8.58|3.17|
71063179|NCT03349060|141634572|SUPERIORITY||Difference in LS mean|6.071||||0.1915|TWO_SIDED|95.0|-3.107|15.249|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||15.249|-3.107|0.1915
71063180|NCT03349060|141634572|SUPERIORITY||Difference in LS mean|12.948||||0.0064|TWO_SIDED|95.0|3.754|22.143|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||22.143|3.754|0.0064
71110755|NCT04723355|141727156|OTHER||Negative likelihood ratio|0.12|||||TWO_SIDED|95.0|0.06|0.21||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||0.21|0.06|
70937300|NCT02410278|141374602|SUPERIORITY||Hazard Ratio (HR)|0.946||||0.8328|TWO_SIDED|95.0|0.563|1.589|||Regression, Cox|||Hazard ratio and the P-value are based on the Cox's proportional hazard regression model, adjusted for age, weight and baseline GSRS score. Hazard ratio (HR) is the ratio of hazard rates of Montelukast and placebo treatment groups. P-value is from the Wald test that HR is 1. CI = Wald confidence interval.||1.589|0.563|0.8328
70937301|NCT02410278|141374603|SUPERIORITY||adjusted mean difference|0.115||||0.1743|TWO_SIDED|95.0|-0.052|0.283|||Repeated measures model|||Change from Day 1 to Week 1: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.283|-0.052|0.1743
71110756|NCT04723355|141727157|OTHER||Accuracy|0.99|||||TWO_SIDED|95.0|0.97|1.0||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||1.00|0.97|
71110757|NCT04723355|141727157|OTHER||Sensitivity|1.0|||||TWO_SIDED|95.0|0.85|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.85|
71110758|NCT04723355|141727157|OTHER||Specificity|0.99|||||TWO_SIDED|95.0|0.97|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.97|
71110759|NCT04723355|141727157|OTHER||Positive predictive value|0.96|||||TWO_SIDED|95.0|0.78|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.78|
70937302|NCT02410278|141374603|SUPERIORITY||adjusted mean difference|0.079||||0.2677|TWO_SIDED|95.0|-0.063|0.221|||Repeated measures model|||Change from Day 1 to Week 2: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.221|-0.063|0.2677
70937303|NCT02410278|141374603|SUPERIORITY||adjusted mean difference|0.085||||0.1788|TWO_SIDED|95.0|-0.04|0.211|||Repeated measures model|||Change from Day 1 to Week 3: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.211|-0.040|0.1788
70937304|NCT02410278|141374603|SUPERIORITY||adjusted mean difference|0.1||||0.0866|TWO_SIDED|95.0|-0.015|0.216|||Repeated measures model|||Change from Day 1 to Week 4: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.216|-0.015|0.0866
71063181|NCT03349060|141634573|SUPERIORITY||Difference in LS mean|3.6||||0.0102|TWO_SIDED|95.0|0.9|6.4||Analysis of covariance (ANCOVA) model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||6.4|0.9|0.0102
71063182|NCT03349060|141634573|SUPERIORITY||Difference in LS mean|4.5||||0.0013|TWO_SIDED|95.0|1.8|7.3||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||7.3|1.8|0.0013
71063183|NCT03349060|141634574|SUPERIORITY||Difference in LS mean|1.0||||0.5241|TWO_SIDED|95.0|-2.1|4.2||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||4.2|-2.1|0.5241
71110760|NCT04723355|141727157|OTHER||Negative predictive value|1.0|||||TWO_SIDED|95.0|0.98|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.98|
71110761|NCT04723355|141727157|OTHER||Cohen Kappa coefficient|0.97|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
71110762|NCT04723355|141727157|OTHER||Positive likelihood ratio|157.0|||||TWO_SIDED|95.0|22.25|1107.61||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||1107.61|22.25|
71110763|NCT04723355|141727157|OTHER||Negative likelihood ratio|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||0|0|
71110764|NCT04723355|141727158|OTHER||Accuracy|0.85|||||TWO_SIDED|95.0|0.79|0.9||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||0.90|0.79|
71110765|NCT04723355|141727158|OTHER||Sensitivity|0.82|||||TWO_SIDED|95.0|0.71|0.9||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.90|0.71|
71110766|NCT04723355|141727158|OTHER||Specificity|0.88|||||TWO_SIDED|95.0|0.8|0.93||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.93|0.80|
71110767|NCT04723355|141727158|OTHER||Positive predictive value|0.82|||||TWO_SIDED|95.0|0.71|0.9||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.90|0.71|
71110768|NCT04723355|141727158|OTHER||Negative predictive value|0.88|||||TWO_SIDED|95.0|0.8|0.93||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.93|0.80|
71110769|NCT04723355|141727158|OTHER||Cohen Kappa coefficient|0.7|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
70937305|NCT02410278|141374603|SUPERIORITY||adjusted mean difference|0.1||||0.0509|TWO_SIDED|95.0|0.0|0.201|||Repeated measures model|||Change from Day 1 to Week 5: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.201|-0.000|0.0509
70937306|NCT02410278|141374603|SUPERIORITY||adjusted mean difference|0.088||||0.0649|TWO_SIDED|95.0|-0.006|0.182|||Repeated measures model|||Change from Day 1 to Week 6: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.182|-0.006|0.0649
70937307|NCT02410278|141374603|SUPERIORITY||adjusted mean difference|0.088||||0.0479|TWO_SIDED|95.0|0.001|0.176|||Repeated measures model|||Change from Day 1 to Week 7: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.176|0.001|0.0479
70937308|NCT02410278|141374603|SUPERIORITY||adjusted mean difference|0.082||||0.054|TWO_SIDED|95.0|-0.001|0.166|||Repeated measures model|||Change from Day 1 to Week 8: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.166|-0.001|0.0540
70937309|NCT02410278|141374604|SUPERIORITY||adjusted mean difference|0.129||||0.2469|TWO_SIDED|95.0|-0.092|0.349|||Repeated measures model|||Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight (kg) and baseline GSRS score, and has unstructured variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and Day 3.||0.349|-0.092|0.2469
71063184|NCT03349060|141634574|SUPERIORITY||Difference in LS mean|0.9||||0.5821|TWO_SIDED|95.0|-2.3|4.1||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||4.1|-2.3|0.5821
71063185|NCT03349060|141634575|SUPERIORITY||Difference in LS mean|3.8||||0.0013|TWO_SIDED|95.0|1.5|6.1||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||6.1|1.5|0.0013
71063186|NCT03349060|141634575|SUPERIORITY||Difference in LS mean|4.7|||<|0.0001|TWO_SIDED|95.0|2.4|7.0||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||7.0|2.4|<0.0001
71063187|NCT03349060|141634576|SUPERIORITY||Difference in LS mean|1.7||||0.2256|TWO_SIDED|95.0|-1.0|4.4||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||4.4|-1.0|0.2256
71063188|NCT03349060|141634576|SUPERIORITY||Difference in LS mean|3.0||||0.0275|TWO_SIDED|95.0|0.3|5.8||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||5.8|0.3|0.0275
71063189|NCT02861586|141634578|SUPERIORITY||Geometric mean ratio|3.9|||<|0.0001|TWO_SIDED|95.0|2.0|7.7||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||7.7|2.0|<0.0001
71110770|NCT04723355|141727158|OTHER||Positive likelihood ratio|6.79|||||TWO_SIDED|95.0|4.03|11.43||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||11.43|4.03|
71110771|NCT04723355|141727158|OTHER||Negative likelihood ratio|0.21|||||TWO_SIDED|95.0|0.13|0.34||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||0.34|0.13|
70937310|NCT02410278|141374605|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0000
71063190|NCT02861586|141634578|SUPERIORITY||Geometric mean ratio|0.3|||<|0.0001|TWO_SIDED|95.0|0.1|0.6||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.6|0.1|<0.0001
71063191|NCT02861586|141634578|SUPERIORITY||Geometric mean ratio|1.5||||0.6334|TWO_SIDED|95.0|0.8|3.0||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||3.0|0.8|0.6334
71063192|NCT02861586|141634578|SUPERIORITY||Geometric mean ratio|0.6||||0.8065|TWO_SIDED|95.0|0.2|1.6||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||1.6|0.2|0.8065
71063193|NCT02861586|141634578|SUPERIORITY||Geometric mean ratio|10.0|||<|0.0001|TWO_SIDED|95.0|3.8|26.6||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||26.6|3.8|<0.0001
71063194|NCT02861586|141634578|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.0|0.3||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.3|0.0|<0.0001
71110772|NCT04723355|141727159|OTHER||Accuracy|0.93|||||TWO_SIDED|95.0|0.88|0.96||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||0.96|0.88|
71110773|NCT04723355|141727159|OTHER||Sensitivity|0.78|||||TWO_SIDED|95.0|0.56|0.93||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.93|0.56|
71110774|NCT04723355|141727159|OTHER||Specificity|0.95|||||TWO_SIDED|95.0|0.9|0.98||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.98|0.90|
71110775|NCT04723355|141727159|OTHER||Positive predictive value|0.69|||||TWO_SIDED|95.0|0.48|0.86||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.86|0.48|
71110776|NCT04723355|141727159|OTHER||Negative predictive value|0.97|||||TWO_SIDED|95.0|0.93|0.99||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.99|0.93|
71110777|NCT04723355|141727159|OTHER||Cohen Kappa coefficient|0.69|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
71110778|NCT04723355|141727159|OTHER||Positive likelihood ratio|15.26|||||TWO_SIDED|95.0|7.51|30.99||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||30.99|7.51|
71110779|NCT04723355|141727159|OTHER||Negative likelihood ratio|0.23|||||TWO_SIDED|95.0|0.11|0.5||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||0.50|0.11|
71110780|NCT04723355|141727160|OTHER||Accuracy|0.93|||||TWO_SIDED|95.0|0.89|0.96||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||0.96|0.89|
70852565|NCT02522624|141194053|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Linear|||||||<.001
71110781|NCT04723355|141727160|OTHER||Sensitivity|0.58|||||TWO_SIDED|95.0|0.28|0.85||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.85|0.28|
71110782|NCT04723355|141727160|OTHER||Specificity|0.96|||||TWO_SIDED|95.0|0.92|0.98||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.98|0.92|
71110783|NCT04723355|141727160|OTHER||Positive predictive value|0.5|||||TWO_SIDED|95.0|0.23|0.77||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.77|0.23|
71110784|NCT04723355|141727160|OTHER||Negative predictive value|0.97|||||TWO_SIDED|95.0|0.93|0.99||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.99|0.93|
71110785|NCT04723355|141727160|OTHER||Cohen Kappa coefficient|0.77|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
71110786|NCT04723355|141727160|OTHER||Positive likelihood ratio|13.92|||||TWO_SIDED|95.0|5.84|33.17||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||33.17|5.84|
71110787|NCT04723355|141727160|OTHER||Negative likelihood ratio|0.43|||||TWO_SIDED|95.0|0.22|0.85||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||0.85|0.22|
71110788|NCT04723355|141727161|OTHER||Accuracy|0.98|||||TWO_SIDED|95.0|0.95|1.0||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||1.00|0.95|
71110789|NCT04723355|141727161|OTHER||Sensitivity|0.75|||||TWO_SIDED|95.0|0.19|0.99||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.99|0.19|
71110790|NCT04723355|141727161|OTHER||Specificity|0.99|||||TWO_SIDED|95.0|0.96|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.96|
70852566|NCT02522624|141194053|SUPERIORITY_OR_OTHER|||||||0.82|||||||Regression, Linear|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).||||0.82
71110791|NCT04723355|141727161|OTHER||Positive predictive value|0.6|||||TWO_SIDED|95.0|0.15|0.95||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.95|0.15|
71110792|NCT04723355|141727161|OTHER||Negative predictive value|0.99|||||TWO_SIDED|95.0|0.97|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.97|
71110793|NCT04723355|141727161|OTHER||Cohen Kappa coefficient|0.66|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
71110794|NCT04723355|141727161|OTHER||Positive likelihood ratio|65.63|||||TWO_SIDED|95.0|14.8|291.07||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||291.07|14.80|
71110795|NCT04723355|141727161|OTHER||Negative likelihood ratio|0.25|||||TWO_SIDED|95.0|0.05|1.38||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||1.38|0.05|
71063195|NCT02861586|141634578|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.0|0.3||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.3|0.0|<0.0001
71063196|NCT02861586|141634578|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.0|0.1||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.1|0.0|<0.0001
71063197|NCT02861586|141634578|SUPERIORITY||Geometric mean ratio|0.4||||0.0011|TWO_SIDED|95.0|0.2|0.8||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.8|0.2|0.0011
71063198|NCT02861586|141634578|SUPERIORITY||Geometric mean ratio|0.2|||<|0.0001|TWO_SIDED|95.0|0.1|0.4||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.4|0.1|<0.0001
71063199|NCT02861586|141634578|SUPERIORITY||Geometric mean ratio|2.6||||0.0718|TWO_SIDED|95.0|1.0|6.9||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||6.9|1.0|0.0718
71063200|NCT02861586|141634578|SUPERIORITY||Geometric mean ratio|0.4||||0.0593|TWO_SIDED|95.0|0.1|1.0||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||1.0|0.1|0.0593
70937311|NCT02410278|141374606|SUPERIORITY|||||||1|||||||Fisher's Exact|||||||1.0000
70937312|NCT02410278|141374607|SUPERIORITY|||||||0.2604|||||||Chi-squared|||||||0.2604
71063201|NCT02861586|141634578|SUPERIORITY||Gemetric mean ratio|0.4||||0.0593|TWO_SIDED|95.0|0.1|1.0||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||1.0|0.1|0.0593
71063202|NCT02861586|141634578|SUPERIORITY||Geometric mean ratio|5.2|||<|0.0001|TWO_SIDED|95.0|2.6|10.4||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||10.4|2.6|<0.0001
71063203|NCT02861586|141634578|SUPERIORITY||Geometric mean ratio|2.2||||0.2005|TWO_SIDED|95.0|0.8|5.7||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||5.7|0.8|0.2005
71063204|NCT02861586|141634578|SUPERIORITY||Geometric mean ratio|35.0|||<|0.0001|TWO_SIDED|95.0|13.1|93.1||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||93.1|13.1|<0.0001
71063205|NCT02861586|141634578|SUPERIORITY||Geometric mean ratio|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.1||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.1|0.0|<0.0001
71063206|NCT02861586|141634578|SUPERIORITY||Geometric mean ratio|0.0|||<|0.0001|TWO_SIDED|0.0|0.0|0.1|||ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.1|0.0|<0.0001
71063207|NCT02861586|141634578|SUPERIORITY||Geometric mean ratio|0.4||||0.1138|TWO_SIDED|95.0|0.2|1.1||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||1.1|0.2|0.1138
71063208|NCT02861586|141634578|SUPERIORITY||Geometric mean ratio|6.7|||<|0.0001|TWO_SIDED|95.0|2.5|18.1||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||18.1|2.5|<0.0001
71063209|NCT02861586|141634578|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.1|0.4||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.4|0.1|<0.0001
71063210|NCT02861586|141634578|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.1|0.4||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.4|0.1|<0.0001
71110796|NCT04723355|141727162|OTHER||Accuracy|0.98|||||TWO_SIDED|95.0|0.94|0.99||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||0.99|0.94|
71110797|NCT04723355|141727162|OTHER||Sensitivity|0.64|||||TWO_SIDED|95.0|0.31|0.89||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.89|0.31|
71110798|NCT04723355|141727162|OTHER||Specificity|1.0|||||TWO_SIDED|95.0|0.98|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.98|
71110799|NCT04723355|141727162|OTHER||Positive predictive value|1.0|||||TWO_SIDED|95.0|0.59|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.59|
71110800|NCT04723355|141727162|OTHER||Negative predictive value|0.98|||||TWO_SIDED|95.0|0.94|0.99||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.99|0.94|
71110801|NCT04723355|141727162|OTHER||Cohen Kappa coefficient|0.77|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
71110802|NCT04723355|141727162|OTHER|||||||||||||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.|The positive likelihood ratio could not be calculated due to the value of zero in the denominator|||
71110803|NCT04723355|141727162|OTHER||Negative likelihood ratio|0.36|||||TWO_SIDED|95.0|0.17|0.79||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||0.79|0.17|
71063211|NCT02861586|141634578|SUPERIORITY||Geometric mean ratio|16.0|||<|0.0001|TWO_SIDED|95.0|4.9|52.4||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||52.4|4.9|<0.0001
71063212|NCT02861586|141634578|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.0|0.2||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.2|0.0|<0.0001
71063213|NCT02861586|141634578|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.0|0.2||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.2|0.0|<0.0001
71063214|NCT02861586|141634578|SUPERIORITY||Geometric mean ratio|1.0||||1|TWO_SIDED|95.0|0.3|3.3||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||3.3|0.3|1.0000
71063215|NCT02861586|141634578|SUPERIORITY||Geometric mean ratio|1.0||||1|TWO_SIDED|95.0|0.3|3.3||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||3.3|0.3|1.0000
71063216|NCT02861586|141634578|SUPERIORITY||Geometric mean ratio|1.0||||1|TWO_SIDED|95.0|0.3|3.2||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||3.2|0.3|1.0000
71063217|NCT02861586|141634587|SUPERIORITY||Geometric mean ratio|0.9||||0.9775|TWO_SIDED|95.0|0.4|2.0|||ANOVA|Analysis of variance was performed with baseline measles titer group as a fixed factor.||||2.0|0.4|0.9775
71063218|NCT02861586|141634587|SUPERIORITY||Geometric mean ratio|1.3||||0.8366|TWO_SIDED|95.0|0.6|3.1|||ANOVA|Analysis of variance was performed with baseline measles titer group as a fixed factor.||||3.1|0.6|0.8366
71063219|NCT02861586|141634587|SUPERIORITY||Geometric mean ratio|1.5||||0.5625|TWO_SIDED|95.0|0.7|3.6|||ANOVA|Analysis of variance was performed with baseline measles titer group as a fixed factor.||||3.6|0.7|0.5625
71063220|NCT02861586|141634587|SUPERIORITY||Geometric mean ratio|1.5||||0.5924|TWO_SIDED|95.0|0.6|3.5|||ANOVA|Analysis of variance was performed with baseline measles titer group as a fixed factor.||||3.5|0.6|0.5924
71063221|NCT02861586|141634587|SUPERIORITY||Geometric mean ratio|1.8||||0.3122|TWO_SIDED|95.0|0.8|4.1|||ANOVA|Analysis of variance was performed with baseline measles titer group as a fixed factor.||||4.1|0.8|0.3122
71063222|NCT02861586|141634587|SUPERIORITY||Geometric mean ratio|1.2||||0.9665|TWO_SIDED|95.0|0.5|2.8|||ANOVA|Analysis of variance was performed with baseline measles titer group as a fixed factor.||||2.8|0.5|0.9665
71110804|NCT04723355|141727164|OTHER||Mean Difference (Final Values)|-0.94|||||TWO_SIDED|95.0|-6.2|4.31||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||4.31|-6.20|
71063223|NCT00803790|141634600|SUPERIORITY_OR_OTHER_LEGACY||least square mean ratio|1.01|||||TWO_SIDED|90.0|0.92|1.11||||||||1.11|0.92|
71063224|NCT00803790|141634601|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Ratio|0.94|||||TWO_SIDED|90.0|0.89|1.0||||||Least squares mean ratio for AUC 0-80 hr for vitamin D following administration of combination tablet and vitamin D alone. No correction for endogenous Vitamin D concentration pre-treatment was made in the analysis.||1.00|0.89|
71063225|NCT00803790|141634602|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Ratio|0.94|||||TWO_SIDED|90.0|0.88|1.0||||||"Least squares mean ratio for Cmax for vitamin D following administration of combination tablet and vitamin D alone.~No correction for endogenous Vitamin D concentration pre-treatment was made in the analysis."||1.00|0.88|
71063226|NCT05161481|141634608|OTHER|"The adjusted mean values for percentage change at Week 24 are derived for each group using the MMRM. The mean difference for the Comparison vs Placebo, is the adjusted mean of the treatment group subtracted from the adjusted mean of the placebo group."|Difference of adjusted means|-8.4|STANDARD_ERROR_OF_MEAN|8.9|||TWO_SIDED|95.0|-26.25|9.45||||||Model includes baseline HVPG as linear covariate and treatment and use of NSBBs or carvedilol as fixed effects, treatment by visit interaction and baseline HVPG by visit interaction. The following covariance structure has been used to fit the mixed model: Unstructured.||9.45|-26.25|
71063227|NCT05161481|141634608|OTHER|"The adjusted mean values for percentage change at Week 24 are derived for each group using the MMRM. The mean difference for the Comparison vs Placebo, is the adjusted mean of the treatment group subtracted from the adjusted mean of the placebo group."|Difference of adjusted means|-14.18|STANDARD_ERROR_OF_MEAN|9.93|||TWO_SIDED|95.0|-34.09|5.72||||||Model includes baseline HVPG as linear covariate and treatment and use of NSBBs or carvedilol as fixed effects, treatment by visit interaction and baseline HVPG by visit interaction. The following covariance structure has been used to fit the mixed model: Unstructured.||5.72|-34.09|
71063228|NCT05161481|141634609|OTHER|"The adjusted mean values for percentage change at Week 8 are derived for each group using the MMRM. The mean difference for the Comparison vs Placebo, is the adjusted mean of the treatment group subtracted from the adjusted mean of the placebo group."|Difference of adjusted means|3.51|STANDARD_ERROR_OF_MEAN|6.23|||TWO_SIDED|95.0|-8.94|15.96||||||The analysis of covariance (ANCOVA) model includes baseline hepatic venous pressure gradient (HVPG) as a linear covariate, with treatment and use of non-selective beta-blockers (NSBBs) or carvedilol as fixed effects. All intercurrent events (ICEs) will be handled using the treatment policy for the primary objective as a sensitivity analysis. That is, all data collected after the intercurrent events will be included in the analysis.||15.96|-8.94|
71063229|NCT05161481|141634609|OTHER|"The adjusted mean values for percentage change at Week 8 are derived for each group using the MMRM. The mean difference for the Comparison vs Placebo, is the adjusted mean of the treatment group subtracted from the adjusted mean of the placebo group."|Difference of adjusted means|2.69|STANDARD_ERROR_OF_MEAN|6.82|||TWO_SIDED|95.0|-10.94|16.33||||||ANCOVA) model includes baseline hepatic venous pressure gradient (HVPG) as a linear covariate, with treatment and use of non-selective beta-blockers (NSBBs) or carvedilol as fixed effects. All intercurrent events (ICEs) will be handled using the treatment policy for the primary objective as a sensitivity analysis. That is, all data collected after the intercurrent events will be included in the analysis.||16.33|-10.94|
71063230|NCT03985800|141634617|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|1.26||||0.53||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time interaction term is 1.26 with two degrees of freedom.||Null hypothesis: The trajectory of IBD complexity score does not differ by treatment group.||||0.53
71110805|NCT04723355|141727164|OTHER||Lin´s concordance correlation coeficient|0.97|||||TWO_SIDED|95.0|0.96|0.98||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.98|0.96|
71110806|NCT04723355|141727165|OTHER||Mean Difference (Final Values)|-2.71|||||TWO_SIDED|95.0|-17.09|11.67||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||11.67|-17.09|
71110807|NCT04723355|141727165|OTHER||Lin´s concordance correlation coeficient|0.95|||||TWO_SIDED|95.0|0.93|0.96||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.96|0.93|
71110808|NCT04723355|141727166|OTHER||Mean Difference (Final Values)|0.39|||||TWO_SIDED|95.0|-5.43|6.22||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||6.22|-5.43|
71110809|NCT04723355|141727166|OTHER||Lin´s concordance correlation coeficient|0.95|||||TWO_SIDED|95.0|0.93|0.96||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.96|0.93|
71110810|NCT04723355|141727167|OTHER||Mean Difference (Final Values)|-6.37|||||TWO_SIDED|95.0|-1391.46|1378.72||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||1378.72|-1391.46|
71110811|NCT04723355|141727167|OTHER||Lin´s concordance correlation coeficient|0.95|||||TWO_SIDED|95.0|0.94|0.96||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.96|0.94|
71110812|NCT04723355|141727168|OTHER||Mean Difference (Final Values)|11.04|||||TWO_SIDED|95.0|-2089.58|2111.65||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||2111.65|-2089.58|
71078086|NCT01026818|141664582|SUPERIORITY_OR_OTHER||LS Mean Differences|0.23|STANDARD_ERROR_OF_MEAN|5.73||0.968||95.0|-11.03|11.49||P-value is for Q3 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||11.49|-11.03|0.968
71110813|NCT04723355|141727168|OTHER||Lin´s concordance correlation coeficient|0.92|||||TWO_SIDED|95.0|0.89|0.94||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.94|0.89|
71110814|NCT04723355|141727169|OTHER||Mean Difference (Final Values)|-0.12|||||TWO_SIDED|95.0|-5.45|5.2||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||5.20|-5.45|
71110815|NCT04723355|141727169|OTHER||Lin´s concordance correlation coeficient|0.93|||||TWO_SIDED|95.0|0.91|0.94||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.94|0.91|
71110816|NCT04723355|141727170|OTHER||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-13.38|12.07||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||12.07|-13.38|
71110817|NCT04723355|141727170|OTHER||Lin´s concordance correlation coeficient|0.987|||||TWO_SIDED|95.0|0.98|0.99||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.99|0.98|
71110818|NCT04723355|141727171|OTHER||Mean Difference (Final Values)|-0.09|||||TWO_SIDED|95.0|-1.75|1.56||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||1.56|-1.75|
71110819|NCT04723355|141727171|OTHER||Lin´s concordance correlation coeficient|0.9976|||||TWO_SIDED|95.0|0.997|0.998||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.998|0.997|
71110820|NCT04723355|141727172|SUPERIORITY||chi-squared test statistic|23.529|||<|0.0001|TWO_SIDED||||||Chi-squared|||||||<0.0001
71110821|NCT01109108|141727173|OTHER||Risk Ratio (RR)|1.0|||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
71110822|NCT01516632|141727197|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62|||||TWO_SIDED|95.0|0.82|3.21||||||||3.21|.82|
71110823|NCT01516632|141727198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.55|||||TWO_SIDED|95.0|1.22|5.3||||||||5.30|1.22|
71110824|NCT01516632|141727199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.33|||||TWO_SIDED|95.0|1.48|7.45||||||||7.45|1.48|
70852567|NCT02522624|141194053|SUPERIORITY_OR_OTHER|||||||0.15|||||||Regression, Linear|||Controlling for Numeracy.||||0.15
71078087|NCT01026818|141664582|SUPERIORITY_OR_OTHER||LS Mean Differences|-5.51|STANDARD_ERROR_OF_MEAN|5.62||0.327|TWO_SIDED|95.0|-16.55|5.54||P-value is for Q3 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||5.54|-16.55|0.327
71110825|NCT00348946|141727210|SUPERIORITY|BOT Visual-motor control||||||0.005|||||||ANCOVA|||||||0.005
71110826|NCT00348946|141727210|SUPERIORITY|||||||0.17|||||||ANCOVA|||BOT upper limb speed||||0.17
71110827|NCT00348946|141727210|SUPERIORITY|||||||0.17|||||||ANCOVA|||BOT strength||||0.17
71110828|NCT00348946|141727210|SUPERIORITY|||||||0.06|||||||ANCOVA|||Hand dynamometer||||0.06
71110829|NCT00348946|141727210|SUPERIORITY|||||||0.87|||||||ANCOVA|||PANESS||||0.87
71110830|NCT00348946|141727211|SUPERIORITY|||||||0.44|||||||ANCOVA|||DAS: General concept ability||||0.44
71110831|NCT00348946|141727211|SUPERIORITY|||||||0.57|||||||ANCOVA|||DAS: Verbal Cluster||||0.57
71063231|NCT03985800|141634617|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|1.14||||0.57||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*age interaction term is 1.14 with two degrees of freedom.||Aim 2b., moderation by age. Null hypothesis: Age does not moderate the trajectory of complexity score by treatment group.||||0.57
71063232|NCT03985800|141634617|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|0.08||||0.96||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*diagnosis interaction term is 0.08 with two degrees of freedom.||Aim 2b., moderation by diagnosis. Null hypothesis: Diagnosis does not moderate the trajectory of complexity score by treatment group.||||0.96
71063233|NCT03985800|141634617|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|6.41||||0.17||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*site interaction term is 6.41 with two degrees of freedom.||Aim 2b., moderation by site. Null hypothesis: Site does not moderate the trajectory of complexity score by treatment group.||||0.17
71063234|NCT03985800|141634617|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|2.6||||0.27||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*site interaction term is 2.6 with two degrees of freedom.||Aim 2b., moderation by eHealth literacy. Null hypothesis: eHealth literacy does not moderate the trajectory of complexity score by treatment group.||||0.27
71063235|NCT03985800|141634618|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|0.21||||0.9||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time interaction term is 0.21 with two degrees of freedom.||Aim 1. The trajectory of PHQ-ADS does not differ by treatment group.||||0.90
71063236|NCT03985800|141634618|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|1.21||||0.55||||||Threshold for statistical significance was 0.05.|Mixed Models Analysis|||Aim 2a, moderation by disease activity. Null hypothesis: Disease activity does not moderate the trajectory of behavioral health score by treatment group.||||0.55
71063237|NCT03985800|141634618|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|1.37||||0.5||||||Threshold for statistical significance was 0.05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*age interaction term is 1.37 with two degrees of freedom.||Aim 2b, moderation by age. Null hypothesis: Age does not moderate the trajectory of behavioral health score by treatment group.||||0.50
71063238|NCT03985800|141634618|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|5.16||||0.08||||||Threshold for statistical significance was 0.05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*diagnosis interaction term is 5.16 with two degrees of freedom.||Aim 2b, moderation by diagnosis. Null hypothesis: Diagnosis does not moderate the trajectory of behavioral health score by treatment group.||||0.08
71078088|NCT01026818|141664582|SUPERIORITY_OR_OTHER||LS Mean Differences|11.67|STANDARD_ERROR_OF_MEAN|6.32||0.066|TWO_SIDED|95.0|-0.76|24.09||P-value is for Q3 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||24.09|-0.76|0.066
71078089|NCT01026818|141664582|SUPERIORITY_OR_OTHER||LS Mean Differences|5.09|STANDARD_ERROR_OF_MEAN|6.23||0.415|TWO_SIDED|95.0|-7.17|17.34||P-value is for Q3 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||17.34|-7.17|0.415
71110832|NCT00348946|141727211|SUPERIORITY|||||||0.55|||||||ANCOVA|||DAS: Nonverbal Cluster||||0.55
71110833|NCT00348946|141727211|SUPERIORITY|||||||0.65|||||||ANCOVA|||DAS: Spatial Cluster||||0.65
71110834|NCT00348946|141727212|SUPERIORITY|||||||0.23|||||||ANCOVA|||Digit Span backward||||0.23
71110835|NCT00348946|141727212|SUPERIORITY|||||||0.36|||||||ANCOVA|||Phonetic fluency||||0.36
71110836|NCT00348946|141727212|SUPERIORITY|||||||0.37|||||||ANCOVA|||Semantic fluency||||0.37
71063239|NCT03985800|141634618|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|0.11||||1||||||Threshold for statistical significance was 0.05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*site interaction term is 0.11 with two degrees of freedom.||Aim 2b, moderation by site. Null hypothesis: Site does not moderate the trajectory of behavioral health score by treatment group.||||1.0
71063240|NCT03985800|141634618|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|3.23||||0.2||||||Threshold for statistical significance was 0.05|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*eHealth literacy interaction term is 3.23 with two degrees of freedom.||Aim 2b, moderation by eHealth literacy. Null hypothesis: eHealth literacy does not moderate the trajectory of behavioral health score by treatment group.||||0.20
71063241|NCT03985800|141634619|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|3.09||||0.53||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time interaction term is 3.09 with two degrees of freedom.||Null hypothesis: The trajectory of functional impairment does not differ by treatment group.||||0.53
71063242|NCT03985800|141634620|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|6.01||||0.05||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time interaction term is 6.01 with two degrees of freedom.||Null hypothesis: The trajectory of IBD-IBS symptom severity does not differ by treatment group.||||0.05
71063243|NCT03985800|141634621|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|4.14||||0.13||||||The threshold for statistical significance was .05.|Mixed Models Analysis|For hospitalizations, the Chi-squared statistic for the group\*time interaction term is 4.14 with two degrees of freedom||Null hypothesis: The trajectory of hospitalizations does not differ by treatment group.||||0.13
71063244|NCT03985800|141634621|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|0.82||||0.67||||||The threshold for statistical significance was .05.|Mixed Models Analysis|For ED visits, the Chi-squared statistic for the group\*time interaction term is 0.82 with two degrees of freedom.||Null hypothesis: The trajectory of ED visits does not differ by treatment group.||||0.67
71063245|NCT03985800|141634622|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|1.98||||0.37||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time interaction term is 1.98 with two degrees of freedom.||Null hypothesis: The trajectory of self-efficacy does not differ by treatment group.||||0.37
71063246|NCT03985800|141634623|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|5.57||||0.06||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time interaction term is 5.57 with two degrees of freedom.||Null hypothesis: The trajectory of quality of life does not differ by treatment group.||||0.06
71063247|NCT01256450|141634733|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.587|TWO_SIDED|95.0|-0.646|0.366|||ANCOVA|||||0.366|-0.646|.5870
71063248|NCT04242498|141634773|SUPERIORITY||Odds Ratio (OR)|2.422||||0.004|TWO_SIDED|97.5|1.221|4.804|||Regression, Logistic|||||4.804|1.221|0.004
71110837|NCT00348946|141727212|SUPERIORITY|||||||0.41|||||||ANCOVA|||CPT: omissions||||0.41
71110838|NCT00348946|141727212|SUPERIORITY|||||||0.73|||||||ANCOVA|||CPT: commissions||||0.73
71110839|NCT00348946|141727212|SUPERIORITY|||||||0.4|||||||ANCOVA|||CPT: hit reaction time||||0.40
70941753|NCT04748445|141383935|OTHER||Slope|-0.001551|STANDARD_ERROR_OF_MEAN|6.294||0.0151|TWO_SIDED|90.0|-0.002594|-0.0005077|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 03 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0005077|-0.002594|0.0151
71063249|NCT04242498|141634773|SUPERIORITY||Odds Ratio (OR)|2.287||||0.003|TWO_SIDED|97.5|1.22|4.291|||Regression, Logistic|||||4.291|1.220|0.003
71110840|NCT00348946|141727212|SUPERIORITY|||||||0.95|||||||ANCOVA|||CPT: variability||||0.95
71110841|NCT00348946|141727212|SUPERIORITY|||||||0.78|||||||ANCOVA|||CPT: preservations||||0.78
71110842|NCT00348946|141727213|SUPERIORITY|||||||0.16|||||||ANCOVA|||CBCL: Behavior total||||0.16
71110843|NCT00348946|141727213|SUPERIORITY|||||||0.1|||||||ANCOVA|||CBCL: Internalizing total||||0.10
71110844|NCT00348946|141727213|SUPERIORITY|||||||0.24|||||||ANCOVA|||CBCL: externalizing total||||0.24
71110845|NCT00348946|141727213|SUPERIORITY|||||||0.5|||||||ANCOVA|||CDI: Total||||0.50
71063250|NCT04242498|141634774|SUPERIORITY||Odds Ratio (OR)|2.722||||0.007|TWO_SIDED|97.5|1.182|6.267|||Regression, Logistic|||||6.267|1.182|0.007
71063251|NCT04242498|141634774|SUPERIORITY||Odds Ratio (OR)|3.007||||0.002|TWO_SIDED|97.5|1.374|6.581|||Regression, Logistic|||||6.581|1.374|0.002
71063252|NCT04242498|141634775|SUPERIORITY||Odds Ratio (OR)|0.798||||0.497|TWO_SIDED|97.5|0.378|1.683|||Regression, Logistic|||||1.683|0.378|0.497
71063253|NCT04242498|141634775|SUPERIORITY||Odds Ratio (OR)|1.05||||0.868|TWO_SIDED|97.5|0.541|2.041|||Regression, Logistic|||||2.041|0.541|0.868
71063254|NCT04242498|141634776|SUPERIORITY||LS mean difference|-2.393|||<|0.001|TWO_SIDED|97.5|-3.92|-0.867||Nominal p-value only due to the testing hierarchy failing on the flare outcome.|ANCOVA|||||-0.867|-3.920|<0.001
70852568|NCT02522624|141194054|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.1|TWO_SIDED|95.0|0.92|2.36||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Logistic|||||2.36|0.92|0.10
71063255|NCT04242498|141634776|SUPERIORITY||LS mean difference|-2.309|||<|0.001||97.5|-3.705|-0.914||Nominal p-value only due to the testing hierarchy failing on the flare outcome.|ANCOVA|||||-0.914|-3.705|<0.001
71063256|NCT04242498|141634777|SUPERIORITY||LS mean difference|-0.898||||0.01|TWO_SIDED|97.5|-1.684|-0.113||Nominal p-value only due to the testing hierarchy failing on the flare outcome.|ANCOVA|||||-0.113|-1.684|0.010
71063257|NCT04242498|141634777|SUPERIORITY||LS mean difference|-1.265|||<|0.001|TWO_SIDED|97.5|-1.978|-0.552||Nominal p-value only due to the testing hierarchy failing on the flare outcome.|ANCOVA|||||-0.552|-1.978|<0.001
71063258|NCT04242498|141634778|SUPERIORITY||Odds Ratio (OR)|3.273||||0.028|TWO_SIDED|97.5|0.974|10.997||Nominal p-value only due to the testing hierarchy failing on the flare outcome.|Regression, Logistic|||||10.997|0.974|0.028
71063259|NCT04242498|141634778|SUPERIORITY||Odds Ratio (OR)|3.756||||0.01|TWO_SIDED|97.5|1.189|11.867||Nominal p-value only due to the testing hierarchy failing on the flare outcome.|Regression, Logistic|||||11.867|1.189|0.010
71078090|NCT01026818|141664582|SUPERIORITY_OR_OTHER||LS Mean Differences|11.87|STANDARD_ERROR_OF_MEAN|4.61||0.011|TWO_SIDED|95.0|2.79|20.94||P-value is for Q4 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||20.94|2.79|0.011
71078091|NCT01026818|141664582|SUPERIORITY_OR_OTHER||LS Mean Differences|3.85|STANDARD_ERROR_OF_MEAN|4.51||0.394|TWO_SIDED|95.0|-5.03|12.72||P-value is for Q4 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||12.72|-5.03|0.394
71078092|NCT01026818|141664582|SUPERIORITY_OR_OTHER||LS Mean Differences|-1.94|STANDARD_ERROR_OF_MEAN|4.75||0.684|TWO_SIDED|95.0|-11.28|7.41||P-value is for Q4 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||7.41|-11.28|0.684
71078093|NCT01026818|141664582|SUPERIORITY_OR_OTHER||LS Mean Differences|-7.14|STANDARD_ERROR_OF_MEAN|4.66||0.126|TWO_SIDED|95.0|-16.3|2.02||P-value is for Q4 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.02|-16.30|0.126
70852569|NCT02522624|141194054|SUPERIORITY_OR_OTHER|||||||0.26|||||||Regression, Logistic|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).||||0.26
70852570|NCT02522624|141194054|SUPERIORITY_OR_OTHER|||||||0.58|||||||Regression, Linear|||Controlling for Numeracy.||||0.58
71078094|NCT01026818|141664582|SUPERIORITY_OR_OTHER||LS Mean Differences|11.52|STANDARD_ERROR_OF_MEAN|6.13||0.061|TWO_SIDED|95.0|-0.53|23.57||P-value is for Q4 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||23.57|-0.53|0.061
71078095|NCT01026818|141664582|SUPERIORITY_OR_OTHER||LS Mean Differences|5.06|STANDARD_ERROR_OF_MEAN|6.05||0.403|TWO_SIDED|95.0|-6.83|16.95||P-value is for Q4 - Month13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||16.95|-6.83|0.403
71078096|NCT01026818|141664582|SUPERIORITY_OR_OTHER||LS Mean Differences|11.38|STANDARD_ERROR_OF_MEAN|4.58||0.013||95.0|2.38|20.38||P-value is for Q5 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||20.38|2.38|0.013
71078097|NCT01026818|141664582|SUPERIORITY_OR_OTHER||LS Mean Differences|3.69|STANDARD_ERROR_OF_MEAN|4.47||0.41|TWO_SIDED|95.0|-5.11|12.49||P-value is for Q5 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||12.49|-5.11|0.410
71078098|NCT01026818|141664582|SUPERIORITY_OR_OTHER||LS Mean Differences|-2.85|STANDARD_ERROR_OF_MEAN|4.61||0.537|TWO_SIDED|95.0|-11.92|6.22||P-value is for Q5 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||6.22|-11.92|0.537
71078099|NCT01026818|141664582|SUPERIORITY_OR_OTHER||LS Mean Differences|-8.59|STANDARD_ERROR_OF_MEAN|4.52||0.058|TWO_SIDED|95.0|-17.48|0.3||P-value is for Q5 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.30|-17.48|0.058
71078100|NCT01026818|141664582|SUPERIORITY_OR_OTHER||LS Mean Differences|11.44|STANDARD_ERROR_OF_MEAN|6.09||0.061|TWO_SIDED|95.0|-0.54|23.41||P-value is for Q5 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||23.41|-0.54|0.061
71078101|NCT01026818|141664582|SUPERIORITY_OR_OTHER||LS Mean Differences|5.59|STANDARD_ERROR_OF_MEAN|6.01||0.353|TWO_SIDED|95.0|-6.23|17.4||P-value is for Q5 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||17.40|-6.23|0.353
71078102|NCT01026818|141664583|SUPERIORITY_OR_OTHER||LS Mean Differences|-5.12|STANDARD_ERROR_OF_MEAN|3.66||0.162|TWO_SIDED|95.0|-12.32|2.08|||ANCOVA|ANCOVA model included treatment, baseline, age group, and country.||||2.08|-12.32|0.162
71063260|NCT04760626|141634782|NON_INFERIORITY|Non-inferiority of insulin icodec was considered confirmed if the upper limit of the two-sided 95% confidence interval (CI) for mean treatment difference (insulin icodec with doseguide minus once daily basal insulin analogue) was strictly below 0.3 percent point.|Treatment difference|-0.38|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.09|||ANCOVA|||The response and change from baseline in response after 52 weeks were analysed using an analysis of covariance (ANCOVA) model with region and randomised treatment as fixed factors, and baseline HbA1c as a covariate.||-0.09|-0.66|<0.0001
71110846|NCT00348946|141727214|SUPERIORITY|||||||0.15|||||||ANCOVA|||||||0.15
71110847|NCT02820844|141727244|OTHER||Mean Difference (Net)|-2.16|||<|0.001|TWO_SIDED|95.0|-3.14|-1.18||Analysis was performed using mixed-model for repeated measures (MMRM) with treatment, site, visit, treatment-by-visit interaction, Baseline value, Baseline-by-visit interaction as fixed effects.|MMRM||Mean difference (Net) at Week 12 has been presented.|||-1.18|-3.14|<0.001
71078103|NCT01026818|141664583|SUPERIORITY_OR_OTHER||LS Mean Differences|-1.88|STANDARD_ERROR_OF_MEAN|3.61||0.603||95.0|-8.99|5.24|||ANCOVA|ANCOVA model included treatment, baseline, age group, and country.||||5.24|-8.99|0.603
70852571|NCT02522624|141194055|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.52|||<|0.001|TWO_SIDED|95.0|1.58|4.01||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Logistic|||||4.01|1.58|<.001
71078104|NCT01026818|141664587|SUPERIORITY_OR_OTHER||LS Mean Differences|3.49|STANDARD_ERROR_OF_MEAN|2.7||0.196|TWO_SIDED|95.0|-1.82|8.8||P-value is for Urinary Incontinence - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||8.80|-1.82|0.196
71078105|NCT01026818|141664587|SUPERIORITY_OR_OTHER||LS Mean Differences|0.53|STANDARD_ERROR_OF_MEAN|2.65||0.841|TWO_SIDED|95.0|-4.69|5.75||P-value is for Urinary Incontinence - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||5.75|-4.69|0.841
71078106|NCT01026818|141664587|SUPERIORITY_OR_OTHER||LS Mean Differences|1.98|STANDARD_ERROR_OF_MEAN|2.76||0.474|TWO_SIDED|95.0|-3.45|7.4||P-value is for Urinary Incontinence - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||7.40|-3.45|0.474
71078107|NCT01026818|141664587|SUPERIORITY_OR_OTHER||LS Mean Differences|0.1|STANDARD_ERROR_OF_MEAN|2.7||0.971|TWO_SIDED|95.0|-5.21|5.41||P-value is for Urinary Incontinence - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||5.41|-5.21|0.971
71078108|NCT01026818|141664587|SUPERIORITY_OR_OTHER||LS Mean Differences|1.57|STANDARD_ERROR_OF_MEAN|1.32||0.236|TWO_SIDED|95.0|-1.03|4.17||P-value is for Urinary Irritative/Obstructive - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||4.17|-1.03|0.236
71078109|NCT01026818|141664587|SUPERIORITY_OR_OTHER||LS Mean Differences|1.02|STANDARD_ERROR_OF_MEAN|1.29||0.429|TWO_SIDED|95.0|-1.52|3.56||P-value is for Urinary Irritative/Obstructive - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||3.56|-1.52|0.429
71078110|NCT01026818|141664587|SUPERIORITY_OR_OTHER||LS Mean Differences|1.56|STANDARD_ERROR_OF_MEAN|1.36||0.252|TWO_SIDED|95.0|-1.12|4.24||P-value is for Urinary Irritative/Obstructive - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||4.24|-1.12|0.252
71078111|NCT01026818|141664587|SUPERIORITY_OR_OTHER||LS Mean Differences|1.52|STANDARD_ERROR_OF_MEAN|1.32||0.251|TWO_SIDED|95.0|-1.08|4.11||P-value is for Urinary Irritative/Obstructive - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||4.11|-1.08|0.251
71078112|NCT01026818|141664587|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.54|STANDARD_ERROR_OF_MEAN|1.27||0.671|TWO_SIDED|95.0|-3.03|1.95||P-value is for Bowel - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.95|-3.03|0.671
71078113|NCT01026818|141664587|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.21|STANDARD_ERROR_OF_MEAN|1.24||0.868|TWO_SIDED|95.0|-2.64|2.23||P-value is for Bowel - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.23|-2.64|0.868
71078114|NCT01026818|141664587|SUPERIORITY_OR_OTHER||LS Mean Differences|0.1|STANDARD_ERROR_OF_MEAN|1.25||0.938|TWO_SIDED|95.0|-2.37|2.57||P-value is for Bowel - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.57|-2.37|0.938
71078115|NCT01026818|141664587|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.29|STANDARD_ERROR_OF_MEAN|1.22||0.813|TWO_SIDED|95.0|-2.69|2.12||P-value is for Bowel - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.12|-2.69|0.813
71078116|NCT01026818|141664587|SUPERIORITY_OR_OTHER||LS Mean Differences|9.55|STANDARD_ERROR_OF_MEAN|3.28||0.004|TWO_SIDED|95.0|3.1|15.99||P-value is for Sexual - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||15.99|3.10|0.004
71078117|NCT01026818|141664587|SUPERIORITY_OR_OTHER||LS Mean Differences|2.69|STANDARD_ERROR_OF_MEAN|3.21||0.403|TWO_SIDED|95.0|-3.63|9.0||P-value is for Sexual - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||9.00|-3.63|0.403
71110848|NCT02820844|141727245|OTHER||Mean Difference (Net)|29.69|||<|0.001|TWO_SIDED|95.0|18.47|40.91||Analysis performed using MMRM, with treatment, site, visit, Baseline urinary urgency incontinence (UUI) episodes over 3 day diary (\<=9 or \>=10), treatment-by-visit interaction, Baseline value, Baseline-by-visit interaction as fixed effects.|MMRM||Mean difference (Net) at Week 12 has been presented.|||40.91|18.47|<0.001
71110849|NCT02820844|141727300|OTHER||Hazard Ratio (HR)|0.45|||<|0.001|TWO_SIDED|95.0|0.34|0.6||P-value is from log-rank test stratified by Baseline urinary urgency incontinence episodes over 3 day diary (\<=9 versus \>=10).|Log Rank||Hazard ratio and 95% Confidence Interval (CI) are estimated using the Cox proportional hazard model with treatment and Baseline urinary urgency incontinence episodes over 3 day diary (\<=9 versus \>=10) as fixed effect.|||0.60|0.34|<0.001
71110850|NCT02820844|141727301|OTHER||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.38|0.66||P-value is from log-rank test stratified by Baseline urinary urgency incontinence episodes over 3 day diary (\<=9 versus \>=10)|Log Rank||Hazard ratio and 95% CI are estimated using the Cox proportional hazard model with treatment and Baseline urinary urgency incontinence episodes over 3 day diary (\<=9 versus \>=10) as fixed effect.|||0.66|0.38|<0.001
71110851|NCT02266147|141727363|OTHER|MTD was not observed because no DLTs occurred at the maximum dose tested. Because this is a safety endpoint, a statistical analysis was not conducted.||||||||||||||||MTD was not observed because no DLTs occurred at the maximum dose tested. Because this is a safety endpoint, a statistical analysis was not conducted.|MTD was not observed because no DLTs occurred at the maximum dose tested. Because this is a safety endpoint, a statistical analysis was not conducted.|||
71110852|NCT01896687|141727400|SUPERIORITY_OR_OTHER||||||<|0.001||||||"The worst pain and interference scores as dependent variables, and time (baseline, 1-, and 3 week follow up visit), group (Calmare or Sham), and group by time interaction terms as the independent variable."|ANOVA|||||||<0.001
71110853|NCT02831855|141727401|NON_INFERIORITY|Non-inferiority (NI) of Tofacitinib 11 mg + Methotrexate Placebo to Tofacitinib 11 mg + continued Methotrexate was concluded if the upper bound of 95% 2-sided confidence interval (CI) for difference between the 2 arms (Tofacitinib 11 mg + Methotrexate Placebo reporting arm - Tofacitinib 11 mg + continued Methotrexate arm) was lower than 0.6.|Least Square (LS) Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.09||0.0005|TWO_SIDED|95.0|0.12|0.48||The p-value is one-sided for the test against the NI margin of 0.6.|MMRM|||Linear mixed-effect model of repeated measures (MMRM) was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a biological disease-modifying anti-rheumatic drug (bDMARD), and baseline DAS28-4 (ESR) value as a covariate.||0.48|0.12|0.0005
70852572|NCT02522624|141194055|SUPERIORITY_OR_OTHER|||||||0.39||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Logistic|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).||||0.39
71063261|NCT01753310|141634789|SUPERIORITY_OR_OTHER||Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|1.95|<|0.001|TWO_SIDED|95.0|-12.17|-4.47|||t-test, 2 sided|The 2 sided t-test was on weighted overall treatment difference.|Based on the sample size weighted overall treatment difference.|The superiority of Dysport® to placebo was tested at a two-tailed 5% level by using a stratified analysis of covariance (ANCOVA) with baseline TWSTRS total score as covariate and stratified by the randomisation stratification factor (BoNT-A naïve versus BoNT-A non-naïve).||-4.47|-12.17|<0.001
71063262|NCT01753310|141634790|SUPERIORITY_OR_OTHER||Mean Difference|-5.4|STANDARD_ERROR_OF_MEAN|1.65|=|0.001|TWO_SIDED|95.0|-8.67|-2.14|||t-test, 2 sided|The 2 sided t-test was on weighted overall treatment difference.|Based on the sample size weighted overall treatment difference.|The superiority of Dysport® to placebo was tested at a two-tailed 5% level by using a stratified ANCOVA with baseline TWSTRS total score as covariate and stratified by the randomisation stratification factor (BoNT-A naïve versus BoNT-A non-naïve).||-2.14|-8.67|=0.001
71063263|NCT01753310|141634791|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||The superiority of Dysport® to placebo on CGIC of CD was tested at a two-tailed 5% level by using an analysis of variance (ANOVA) with treatment and randomisation stratification factor as main effects.||||<0.001
71063264|NCT01753310|141634792|SUPERIORITY_OR_OTHER||||||=|0.033|||||||Mantel-Haenszel chi-squared test|||The superiorty of Dysport® to placebo on treatment response was tested at a two-tailed 5% level by using a Mantel-Haenszel chi-squared test stratified by the randomisation factor.||||=0.033
71063265|NCT01753310|141634793|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||The superiority of Dysport® to placebo on CGIC of CD was tested at a two-tailed 5% level by using an ANOVA with treatment and randomisation stratification factor as main effects.||||<0.001
71063266|NCT01753310|141634794|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mantel-Haenszel chi-squared test|||The superiorty of Dysport® to placebo on treatment response was tested at a two-tailed 5% level by using a Mantel-Haenszel chi-squared test stratified by the randomisation factor.||||<0.001
71063267|NCT01753310|141634795|SUPERIORITY_OR_OTHER||||||=|0.174|||||||ANOVA|||The superiority of Dysport® to placebo on CDIP-58 was tested at a two-tailed 5% level by using an ANOVA with treatment and randomisation stratification factor as main effects.||||=0.174
71063268|NCT01753310|141634796|SUPERIORITY_OR_OTHER||||||=|0.583|||||||ANOVA|||The superiority of Dysport® to placebo on CDIP-58 was tested at a two-tailed 5% level by using an ANOVA with treatment and randomisation stratification factor as main effects.||||=0.583
71110854|NCT02831855|141727402|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|0.03|0.41||||||Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline DAS28-4 (ESR) value as a covariate.||0.41|0.03|
71063269|NCT02946463|141634797|NON_INFERIORITY|LDH-N was analyzed using a generalized estimating equation (GEE) approach. The model included the following terms: treatment group, history of transfusion (as a categorical variable based on the stratification factor levels), and baseline LDH level (as a continuous variable). Noninferiority margin was based on the lower bound of the 95% confidence interval (CI) for the odds ratio (OR) of ravulizumab versus eculizumab for LDH normalization being greater than an OR of 0.39.|Odds Ratio (OR)|1.187|||||TWO_SIDED|95.0|0.796|1.769||||||A minimum of 142 participants were estimated to provide 80% power to demonstrate noninferiority of ravulizumab to eculizumab.||1.769|0.796|
71063270|NCT02946463|141634798|NON_INFERIORITY|Noninferiority margin was based on the lower bound of the 95% CI. Noninferiority margin was -20%.|Treatment difference|6.8|||||TWO_SIDED|95.0|-4.66|18.14|||||Treatment difference was estimated for ravulizumab - eculizumab.|A minimum of 193 participants were estimated to provide 80% power to demonstrate noninferiority of ravulizumab to eculizumab. The difference of percentages were calculated using stratified Newcombe CI method. Stratification factors were: observed stratification groups of packed red blood cells (pRBC)/whole blood units transfused in the 1 year prior to first dose of study drug and screening LDH levels.||18.14|-4.66|
71078118|NCT01026818|141664587|SUPERIORITY_OR_OTHER||LS Mean Differences|3.18|STANDARD_ERROR_OF_MEAN|3.82||0.406|TWO_SIDED|95.0|-4.34|10.69||P-value is for Sexual - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||10.69|-4.34|0.406
71078119|NCT01026818|141664587|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.79|STANDARD_ERROR_OF_MEAN|3.72||0.832|TWO_SIDED|95.0|-8.11|6.53||P-value is for Sexual - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||6.53|-8.11|0.832
70852573|NCT02522624|141194055|SUPERIORITY_OR_OTHER|||||||0.57|||||||Regression, Linear|||Controlling for Numeracy.||||0.57
70852574|NCT02522624|141194056|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.32|||<|0.001|TWO_SIDED|95.0|5.94|17.95||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Logistic|||||17.95|5.94|<.001
70852575|NCT02522624|141194056|SUPERIORITY_OR_OTHER|||||||0.001||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Logistic|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).||||0.001
70852576|NCT02522624|141194056|SUPERIORITY_OR_OTHER|||||||0.46|||||||Regression, Linear|||Controlling for numeracy.||||0.46
70852577|NCT02123251|141194057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.2139||0.0553|TWO_SIDED|95.0|-0.0092|0.8293|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, race, gender, and baseline hypertension.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||0.8293|-0.0092|0.0553
70852578|NCT02123251|141194058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2916|STANDARD_ERROR_OF_MEAN|1.9571||0.2416|TWO_SIDED|95.0|-6.1274|1.5442|||Generalized Estimating Equation Model||The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||1.5442|-6.1274|0.2416
70852579|NCT02123251|141194059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0893|STANDARD_ERROR_OF_MEAN|1.2622||0.3881|TWO_SIDED|95.0|-3.5632|1.3846|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||1.3846|-3.5632|0.3881
70852580|NCT02123251|141194060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3432|STANDARD_ERROR_OF_MEAN|7.7086||0.8617|TWO_SIDED|95.0|-16.4517|13.7653|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||13.7653|-16.4517|0.8617
71078120|NCT01026818|141664587|SUPERIORITY_OR_OTHER||LS Mean Differences|1.9|STANDARD_ERROR_OF_MEAN|1.47||0.197|TWO_SIDED|95.0|-0.99|4.79||P-value is for Hormonal - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||4.79|-0.99|0.197
71078121|NCT01026818|141664587|SUPERIORITY_OR_OTHER||LS Mean Differences|2.89|STANDARD_ERROR_OF_MEAN|1.44||0.045|TWO_SIDED|95.0|0.06|5.72||P-value is for Hormonal - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||5.72|0.06|0.045
70937313|NCT02137785|141374627|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Analysis uses observed data only. Missing data was not imputed except for subjects with missing CCR are classified as not having a CCR (ie non-responder).|Cochran-Mantel-Haenszel|CMH test stratified by analysis center||A hierarchical procedure was used to control the level of significance. If the primary analysis was sig (p≤0.05), then AKCR at Week 12 were to be compared. If this analysis was significant, then the AKCR at Week 8 were to be compared. If this analysis was significant, then the CCR at Week 8 was to be compared.||||0.0001
70937314|NCT02137785|141374628|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|linear mixed model with fixed effects for treatment group, time point, and treatment group by time point interaction||||||<0.0001
71063271|NCT02946463|141634799|NON_INFERIORITY|Noninferiority margin was based on the upper bound of the 95% CI. Noninferiority margin was 20%.|Treatment difference|-6.7|||||TWO_SIDED|95.0|-14.21|0.18|||||Treatment difference was estimated for ravulizumab - eculizumab.|The difference of percentages was calculated using stratified Newcombe CI method. The stratification factors were: observed stratification groups of pRBC units transfused in the 1 year prior to first dose of study drug and screening LDH levels.||0.18|-14.21|
71063272|NCT02946463|141634800|NON_INFERIORITY|Noninferiority margin was based on the upper bound of the 95% CI. Noninferiority margin was 20%.|Treatment difference|-0.83|||||TWO_SIDED|95.0|-5.21|3.56|||||Treatment difference was estimated for ravulizumab - eculizumab.|||3.56|-5.21|
71063273|NCT02946463|141634801|NON_INFERIORITY|Noninferiority margin was based on the lower bound of the 95% CI. Noninferiority margin was -5%.|Treatment difference|0.67|||||TWO_SIDED|95.0|-1.21|2.55|||||Treatment difference was estimated for ravulizumab - eculizumab.|||2.55|-1.21|
71063274|NCT02946463|141634802|NON_INFERIORITY|Noninferiority margin was based on the lower bound of the 95% CI. Noninferiority margin was -20%.|Treatment difference|2.9|||||TWO_SIDED|95.0|-8.8|14.64|||||Treatment difference was estimated for ravulizumab - eculizumab.|The difference of percentages was calculated using stratified Newcombe CI method. The stratification factors were: observed stratification groups of pRBC units transfused in the 1 year prior to first dose of study drug and screening LDH levels.||14.64|-8.80|
71063275|NCT01383174|141634803|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||0.015
71063276|NCT01383174|141634804|SUPERIORITY_OR_OTHER|||||||0.465|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.465
71063277|NCT01383174|141634805|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.025
71063278|NCT01383174|141634806|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.004
71063279|NCT01383174|141634807|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.013
71063280|NCT01383174|141634808|SUPERIORITY_OR_OTHER|||||||0.267|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.267
71063281|NCT01383174|141634809|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.030
71063282|NCT01383174|141634810|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.045
71063283|NCT01383174|141634811|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.005
71063284|NCT01383174|141634812|SUPERIORITY_OR_OTHER|||||||0.226|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.226
71063285|NCT04616612|141634822|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||.04
71110855|NCT02831855|141727403|SUPERIORITY||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|0.08|0.43||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment -by-visit interaction, prior use of a bDMARD and baseline DAS28-4 (CRP) value as a covariate.||0.43|0.08|
71110856|NCT02831855|141727403|SUPERIORITY||LS Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|0.11|0.45||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment -by-visit interaction, prior use of a bDMARD and baseline DAS28-4 (CRP) value as a covariate.||0.45|0.11|
71110857|NCT02831855|141727404|SUPERIORITY||LS Mean Difference|1.74|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|95.0|0.4|3.07||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline CDAI value as a covariate.||3.07|0.40|
70937315|NCT02137785|141374629|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|linear mixed model with fixed effects for treatment group, time point, and treatment group by time point interaction||||||<0.0001
70937316|NCT02137785|141374630|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Analysis uses observed data only. Missing data was not imputed except for subjects with missing CCR are classified as not having a CCR (ie non-responder).|Cochran-Mantel-Haenszel|CMH test stratified by analysis center||||||0.0001
70937317|NCT02584257|141374678|SUPERIORITY||Least Square Means Differences|3.171|STANDARD_ERROR_OF_MEAN|0.238|<|0.0001|TWO_SIDED|95.0|2.732|3.61||Fixed effects of dose, week, and sequence and the random effect of the patient was carried out to ensure that the overall treatment effect was significant at p\<0.05|Brief Mixed Models Analysis|For this model, the dependent variable was log2(PC20FEV1) values where PC20FEV1 was measured in mg/mL||||3.610|2.732|<0.0001
70937318|NCT02584257|141374678|SUPERIORITY||Least Square Means Differences|3.824|STANDARD_ERROR_OF_MEAN|0.238|<|0.0001|TWO_SIDED|95.0|3.384|4.263||Fixed effects of dose, week, and sequence and the random effect of the patient was carried out to ensure that the overall treatment effect was significant at p\<0.05.|Brief Mixed Models Analysis|For this model, the dependent variable was log2(PC20FEV1) values where PC20FEV1 was measured in mg/mL||||4.263|3.384|<0.0001
70937319|NCT02584257|141374678|SUPERIORITY||Least Square Means Differences|3.32|STANDARD_ERROR_OF_MEAN|0.241|<|0.0001|TWO_SIDED|95.0|2.876|3.764||Fixed effects of dose, week, and sequence and the random effect of the patient was carried out to ensure that the overall treatment effect was significant at p\<0.05.|Brief Mixed Models Analysis|For this model, the dependent variable was log2(PC20FEV1) values where PC20FEV1 was measured in mg/mL.||||3.764|2.876|<0.0001
70937320|NCT02584257|141374678|SUPERIORITY||Least Square Means Differences|3.872|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|3.43|4.315||Fixed effects of dose, week, and sequence and the random effect of the patient was carried out to ensure that the overall treatment effect was significant at p\<0.05.|Brief Mixed Models Analysis|For this model, the dependent variable was log2(PC20FEV1) values where PC20FEV1 was measured in mg/mL||||4.315|3.430|<0.0001
70937321|NCT02584257|141374678|EQUIVALENCE|A blinded interim analysis was performed after 60 patients completed all treatment visits which determined that 80 subjects would be sufficient to complete the study with 90% power.|Frel|1.15|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|0.93|1.48|||||Frel is the relative bioavailability of the test versus reference product. The CI was a bias corrected and accelerated CI based on a bootstrapping procedure. The FDA acceptable CI was between 0.67 and 1.50.|An Emax model was developed and the 90% confidence interval of Frel was a bias corrected accelerated confidence interval based on a bootstrapping procedure. The bootstrapping procedure used for this analysis was residual resampling. The Per-Protocol population was the primary population for bioequivalence analysis. Patients in the PP population must have completed at least 2 treatment periods with valid PC20FEV1 measurements and had no major protocol deviations within those intervals.||1.48|0.93|
71063286|NCT04616612|141634823|SUPERIORITY|||||||0.04|||||||ANCOVA|||||||.04
71063287|NCT04616612|141634824|OTHER||||||||||||||||||"Qualitative data evaluated from interviews tailored after the acceptability scale questionnaire. These interview questions specifically asked participant to rate from strongly disagree to strongly agree on each question and then rationalize answers.~Mobile support: 77% of participants agreed that mobile messages supported their health behaviors.~Time required: 85% disagreed that the intervention took too much time to learn.~Program effectiveness: 92% enjoyed this learning approach, with 100% agreeing they could use the information to improve health behaviors.~Rationalization feedback found participants in rural areas reported difficulties accessing texts."|||
71063288|NCT04616612|141634825|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||||||0.11
71110858|NCT02831855|141727404|SUPERIORITY||LS Mean Difference|2.13|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|0.83|3.43||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline CDAI value as a covariate.||3.43|0.83|
71110859|NCT02831855|141727405|SUPERIORITY||LS Mean Difference|1.95|STANDARD_ERROR_OF_MEAN|0.72|||TWO_SIDED|95.0|0.53|3.37||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline SDAI value as a covariate.||3.37|0.53|
71110860|NCT02831855|141727405|SUPERIORITY||LS Mean Difference|2.23|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|0.86|3.59||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline SDAI value as a covariate.||3.59|0.86|
71110861|NCT02831855|141727406|SUPERIORITY||Difference in percentage of participants|-5.69|||||TWO_SIDED|95.0|-14.15|2.76||||||Week 36||2.76|-14.15|
71110862|NCT02831855|141727406|SUPERIORITY||Difference in percentage of participants|-4.54|||||TWO_SIDED|95.0|-13.04|3.94||||||Week 48||3.94|-13.04|
70937322|NCT03693989|141374702|OTHER|||||||0.065|||||||t-test, 2 sided|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.065
71110863|NCT02831855|141727407|SUPERIORITY||Difference in percentage of participants|-5.14|||||TWO_SIDED|95.0|-13.07|2.77||||||Week 36||2.77|-13.07|
70937323|NCT03693989|141374703|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.223|||||||t-test, 2 sided|||||||0.223
70937324|NCT03693989|141374704|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.621|||||||Chi-squared, Corrected|||||||0.621
70937325|NCT03693989|141374705|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.246|||||||Fisher Exact|||||||0.246
70937326|NCT03693989|141374706|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.497|||||||Fisher Exact|||||||0.497
71063289|NCT04616612|141634826|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||||||0.11
71063290|NCT04616612|141634827|SUPERIORITY|||||||0.66|||||||Mixed Models Analysis|||||||0.66
71063291|NCT04616612|141634828|SUPERIORITY|||||||0.66|||||||Mixed Models Analysis|||||||0.66
71110864|NCT02831855|141727407|SUPERIORITY||Difference in percentage of participants|-8.52|||||TWO_SIDED|95.0|-16.28|-0.76||||||Week 48||-0.76|-16.28|
71110865|NCT02831855|141727408|SUPERIORITY||Difference in percentage of participants|-7.39|||||TWO_SIDED|95.0|-15.17|0.38||||||Week 36||0.38|-15.17|
70937327|NCT03693989|141374707|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.047|||||||t-test, 2 sided|||||||0.047
70937328|NCT03693989|141374708|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.3|||||||Chi-squared, Corrected|||||||0.300
71063292|NCT04616612|141634829|SUPERIORITY|||||||0.84|||||||Mixed Models Analysis|||||||.84
71063293|NCT04616612|141634830|SUPERIORITY|||||||0.84|||||||Mixed Models Analysis|||||||0.84
71063294|NCT01597973|141634831|SUPERIORITY|||||||0.21|||||||Chi-squared|||||||0.21
71063295|NCT01597973|141634832|SUPERIORITY|||||||0.583|||||||Chi-squared|||||||0.5830
71063296|NCT01597973|141634833|SUPERIORITY|||||||0.07|||||||Chi-squared|||||||0.07
71063297|NCT01597973|141634834|SUPERIORITY|||||||0.255|||||||Chi-squared|||||||0.255
71063298|NCT01597973|141634835|SUPERIORITY|||||||0.59|||||||Chi-squared|||nephrotoxicity analysis||||0.59
71063299|NCT01597973|141634835|SUPERIORITY|||||||0.22|||||||Fisher Exact|||Hypersensitivity analysis||||0.22
71063300|NCT01597973|141634835|SUPERIORITY|||||||0.94|||||||Chi-squared|||Hepatoxicity analysis||||0.94
71063301|NCT01597973|141634835|SUPERIORITY|||||||1|||||||Fisher Exact|||Seizures analysis||||1.00
71063302|NCT01597973|141634835|SUPERIORITY|||||||0.2|||||||Fisher Exact|||Neurotoxicity analysis||||0.20
71063303|NCT04281485|141634840|SUPERIORITY||Least Square Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.78|=|0.9116|TWO_SIDED|95.0|-1.46|1.64|||Mixed Models Analysis||||The Mixed Model Repeated Measures (MMRM) model contained fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction with additional fixed effects for baseline value (continuous variable), screening age (continuous variable), baseline value by visit interaction, and screening age by visit interaction with an unstructured variance-covariance matrix.|1.64|-1.46|=0.9116
71063304|NCT04281485|141634841|SUPERIORITY||Least Square Mean Difference|85.75|STANDARD_ERROR_OF_MEAN|17.17|=|0.0002|TWO_SIDED|95.0|49.15|122.35|||ANCOVA|The ANCOVA model contained treatment group (categorical variable) and screening age (continuous variable).||||122.35|49.15|=0.0002
71063305|NCT04281485|141634842|SUPERIORITY||Least Square Mean Difference|51.46|STANDARD_ERROR_OF_MEAN|9.49|<|0.0001|TWO_SIDED|95.0|31.43|71.49|||ANCOVA|The ANCOVA model contained treatment group (categorical variable) and screening age (continuous variable).||||71.49|31.43|<0.0001
71063306|NCT04281485|141634843|SUPERIORITY||Geometric Ratio of LS Means|0.64|||=|0.0002|TWO_SIDED|95.0|0.5|0.81|||Mixed Models Analysis||||MMRM approach for log transformed data including visits through Week 52 where serum CK concentration was assessed with fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction, and with additional fixed effects for natural log of baseline (continuous variable), screening age covariate (continuous variable), natural log of baseline by visit interaction, and screening age covariate by visit interaction with an unstructured variance-covariance matrix.|0.81|0.50|=0.0002
71110866|NCT02831855|141727408|SUPERIORITY||Difference in percentage of participants|-11.91|||||TWO_SIDED|95.0|-19.56|-4.26||||||Week 48||-4.26|-19.56|
71110867|NCT02831855|141727409|SUPERIORITY||Difference in percentage of participants|-7.02|||||TWO_SIDED|95.0|-14.81|0.77||||||Week 36||0.77|-14.81|
71110868|NCT02831855|141727409|SUPERIORITY||Difference in percentage of participants|-10.02|||||TWO_SIDED|95.0|-17.68|-2.37||||||Week 48||-2.37|-17.68|
71063307|NCT04281485|141634844|SUPERIORITY||Odds Ratio (OR)|1.73|||=|0.2784|TWO_SIDED|95.0|0.64|4.62|||Binomial regression||||The generalized mixed linear model assumed a binomial distribution with logit link \& contains fixed effects for treatment group (categorical variable) \& screening age (continuous variable).|4.62|0.64|=0.2784
71063308|NCT04281485|141634845|SUPERIORITY||Odds Ratio (OR)|0.9|||=|0.5437|TWO_SIDED|95.0|0.63|1.28|||Binomial Regression||||The generalized mixed linear model assumed a binomial distribution with a logit link and contained fixed effects for treatment group (categorical variable) and screening age (continuous variable).|1.28|0.63|=0.5437
71063309|NCT04281485|141634846|SUPERIORITY||Least Square Mean Difference|-0.079|STANDARD_ERROR_OF_MEAN|0.082|=|0.3343|TWO_SIDED|95.0|-0.242|0.083|||Mixed Models Analysis||||The MMRM model contained fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction with additional fixed effects for baseline value (continuous variable), screening age (continuous variable), baseline value by visit interaction, and screening age by visit interaction with an unstructured variance-covariance matrix.|0.083|-0.242|=0.3343
71063310|NCT04281485|141634847|SUPERIORITY||Least Square Mean Difference|-0.004|STANDARD_ERROR_OF_MEAN|0.024|=|0.8826|TWO_SIDED|95.0|-0.052|0.045|||Mixed Models Analysis||||The MMRM model contained fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction with additional fixed effects for baseline value (continuous variable), screening age (continuous variable), baseline value by visit interaction, and screening age by visit interaction with an unstructured variance-covariance matrix.|0.045|-0.052|=0.8826
71063311|NCT04281485|141634848|SUPERIORITY||Least Square Mean Difference|2.01|STANDARD_ERROR_OF_MEAN|1.63|=|0.219|TWO_SIDED|95.0|-1.22|5.24|||Mixed Models Analysis||||The MMRM model contained fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction with additional fixed effects for baseline value (continuous variable), screening age (continuous variable), baseline value by visit interaction, and screening age by visit interaction with an unstructured variance-covariance matrix.|5.24|-1.22|=0.2190
71110869|NCT02831855|141727410|SUPERIORITY||Difference in percentage of participants|-8.52|||||TWO_SIDED|95.0|-15.27|-1.78||||||Week 36||-1.78|-15.27|
71110870|NCT02831855|141727410|SUPERIORITY||Difference in percentage of participants|-1.33|||||TWO_SIDED|95.0|-8.5|5.83|||Two Sided|||Week 48||5.83|-8.50|
71110871|NCT02831855|141727411|SUPERIORITY||Difference in percentage of participants|-8.11|||||TWO_SIDED|95.0|-15.4|-0.82||||||Week 36||-0.82|-15.40|
71110872|NCT02831855|141727411|SUPERIORITY||Difference in percentage of participants|-6.21|||||TWO_SIDED|95.0|-13.74|1.32||||||Week 48||1.32|-13.74|
70937329|NCT03693989|141374709|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.045|||||||t-test, 2 sided|||||||0.045
70937330|NCT03693989|141374710|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.346|||||||Fisher Exact|||burning eyes comparison||||0.346
70937331|NCT03693989|141374710|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.489|||||||Fisher Exact|||Itching eyes comparison||||0.489
70937332|NCT03693989|141374710|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.497|||||||Fisher Exact|||foreign body sensation eyes comparison||||0.497
70937333|NCT03693989|141374710|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||1|||||||Fisher Exact|||blurred vision comparison||||1.000
70937334|NCT00113529|141374711|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|37.1||||||95.0|21.5|55.1|||||ORR=proportion of subjects with confirmed CR or PR, relative to total subjects who received at least 1 dose of study medication, had a baseline disease assessment, and had the correct histological cancer type.|||55.1|21.5|
70937335|NCT00113529|141374717|SUPERIORITY_OR_OTHER||probability|82.4||||||95.0|64.9|91.7||||||||91.7|64.9|
70937336|NCT00113529|141374726|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.075
70937337|NCT00113529|141374726|SUPERIORITY_OR_OTHER|||||||0.749||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.749
71063312|NCT04281485|141634849|SUPERIORITY||Least Square Mean Difference|1.11|STANDARD_ERROR_OF_MEAN|2.96|=|0.7096||95.0|-4.79|7.0|||Mixed Models Analysis||||The MMRM model contained fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction with additional fixed effects for baseline value (continuous variable), screening age (continuous variable), baseline value by visit interaction, and screening age by visit interaction with an unstructured variance-covariance matrix.|7.00|-4.79|=0.7096
71063313|NCT00127231|141634850|EQUIVALENCE||Odds Ratio (OR)|0.42|||<|0.005|TWO_SIDED|95.0|0.23|0.75|||Mixed Models Analysis|||Drinking frequency was analyzed using a generalized binomial mixed-effects model with the logit link function and a random intercept. The use of a binomial distribution was indicated for this analysis because the outcome was assessed using a 90-day TLFB interview, which has a cap at 90 days.||0.75|0.23|<0.005
71063314|NCT00191477|141634938|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.946||||0.777||95.0|0.643|1.392||Only 87 recurrences and 7 deaths were documented at planned end of follow-up. The study was stopped early for futility reasons based on an interim analysis using pre-defined stopping boundaries for the hazard ratio (HR) of RFS.|Log Rank|||Sample-size calculation based on estimated 1-year recurrence-free survival (RFS) rates of 63% (gemcitabine) and 50% (placebo). 191 critical events were required to detect a difference in RFS (80% power, log-rank test, alpha=0.050). Sample size of 328 patients with clinical evidence of superficial bladder cancer needed to observe these 191 events within a 24-month follow-up period, assuming 246 of these patients would receive instillation and have histopathological diagnosis of pTa/pT1(G1-3/Gx).||1.392|0.643|0.777
71063315|NCT01697748|141634981|SUPERIORITY|With an SSI rate of 15% at Tampa General Hospital at the time of study design, a sample size of 600 patients was determined to provide a power of 80% to detect a 50% absolute reduction (15 vs. 7.5%) surgical site infection at a two sided alpha = 0.05. Assuming an approximate 10% dropout loss to follow up rate, the total sample size was adjusted to 660.|Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.44|1.96||Variables with at least a borderline association with a treatment arm (P≤ .10) were included in a multiple logistic regression model to verify which is independently associated with the outcome of interest||No P values were reported for the association between dressing type and infection, only relative risk and 95% confidence intervals were reported.||With an SSI rate of 15% at Tampa General Hospital at the time of study design, a sample size of 600 patients was determined to provide a power of 80% to detect a 50% absolute reduction (15 vs. 7.5%) surgical site infection at a two sided alpha = 0.05. Assuming an approximate 10% dropout loss to follow up rate, the total sample size was adjusted to 660.|Besides the Chi Square, Fisher's Exact test, Student T-test, Mann Whitney U test, and logistic regression were utilized where appropriate|1.96|0.44|
71063316|NCT01697748|141634981|SUPERIORITY|With an SSI rate of 15% at Tampa General Hospital at the time of study design, a sample size of 600 patients was determined to provide a power of 80% to detect a 50% absolute reduction (15% vs. 7.5%) surgical site infection at a two side alpha = 0.05. Assuming an approximate 10% dropout loss to follow up rate, the total sample size was adjusted to 660.|||||<|0.05|TWO_SIDED|95.0||||Variables with at least a borderline association (P≤.10) were then included in a multiple logistic regression model to verify which is independently associated with the outcome of interest|Mixed Models Analysis|In addition to the Chi-Square, Fisher's exact test, Student T-Test, Mann Whitney U test and logistic regression were utilized when appropriate.||||||<0.05
71063317|NCT01697748|141634982|SUPERIORITY||||||<|0.05|||||||see below|Chi square, Fisher Exact, Student t-test, Wilcoxon-Mann-Whitney test where appropriate|||In addition to Chi-Square, Fisher's Exact test, Student T-test, Wilcoxon-Mann Whitney test were utilized where appropriate|||<.05
71063318|NCT01697748|141634983|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Chi Square, Fisher's Exact, Student's T test, Wilcoxon-Mann-Whitney test and logistic regression when appropriate,|||Besides the Chi Square, Fisher's Exact test, Student T-test, Wilcoxon-Mann-Whitney Test, and logistic regression were utilized where appropriate|||<.05
71063319|NCT01697748|141634983|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Chi Square, Fisher Exact, Student t-test, Wilcoxon-Mann-Whitney test|||Besides the Chi Square, Fisher's Exact test, Student T-test, Wilcoxon-Mann-Whitney test and logistic regression were utilized where appropriate|||<.05
71063320|NCT01697748|141634985|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis||||Besides the Chi Square, Fisher's Exact test, Student T-test, Wilcoxon-Mann-Whitney test, and logistic regression were utilized where appropriate|||<0.05
71063321|NCT01697748|141634986|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis||||In addition to the Chi-square, Fisher's exact test, Student T-Test, Wilcoxon-Mann-Whitney test and logistic regression were utilized where approprate|||<0.05
71063322|NCT03889418|141635020|SUPERIORITY||Odds Ratio, log|-0.009|STANDARD_ERROR_OF_MEAN|0.153||0.956|TWO_SIDED|95.0|-0.309|0.292|||Mixed Models Analysis|||||0.292|-0.309|0.956
71063323|NCT03889418|141635021|SUPERIORITY||Risk Ratio, log|-0.103|STANDARD_ERROR_OF_MEAN|0.05||0.039|TWO_SIDED|95.0|-0.2|-0.005|||Mixed Models Analysis|||||-.005|-0.200|0.039
71063324|NCT03889418|141635022|SUPERIORITY||Rate Ratio, log|0.049|STANDARD_ERROR_OF_MEAN|0.282||0.864|TWO_SIDED|95.0|-0.506|0.603|||Mixed Models Analysis|||||0.603|-0.506|0.864
71110873|NCT02831855|141727412|SUPERIORITY||Difference in percentage of participants|-5.63|||||TWO_SIDED|95.0|-14.12|2.84||||||Week 36||2.84|-14.12|
71110874|NCT02831855|141727412|SUPERIORITY||Difference in percentage of participants|-4.13|||||TWO_SIDED|95.0|-12.62|4.36||||||Week 48||4.36|-12.62|
71110875|NCT02831855|141727413|SUPERIORITY||Difference in percentage of participants|-8.84|||||TWO_SIDED|95.0|-16.44|-1.24||||||Week 36||-1.24|-16.44|
71110876|NCT02831855|141727413|SUPERIORITY||Difference in percentage of participants|-2.41|||||TWO_SIDED|95.0|-10.18|5.35||||||Week 48||5.35|-10.18|
71110877|NCT02831855|141727414|SUPERIORITY||Difference in percentage of participants|-8.85|||||TWO_SIDED|95.0|-16.38|-1.31||||||Week 36||-1.31|-16.38|
71110878|NCT02831855|141727414|SUPERIORITY||Difference in percentage of participants|-3.16|||||TWO_SIDED|95.0|-10.99|4.65||||||Week 48||4.65|-10.99|
71110879|NCT02831855|141727415|SUPERIORITY||Difference in percentage of participants|-6.96|||||TWO_SIDED|95.0|-14.06|0.14||||||Week 36||0.14|-14.06|
71110880|NCT02831855|141727415|SUPERIORITY||Difference in percentage of participants|-6.59|||||TWO_SIDED|95.0|-13.8|0.61||||||Week 48||0.61|-13.80|
71063325|NCT03889418|141635023|SUPERIORITY||rate ratio, log|0.018|STANDARD_ERROR_OF_MEAN|0.148||0.901|TWO_SIDED|95.0|-0.272|0.308|||Mixed Models Analysis|||||0.308|-0.272|0.901
71063326|NCT00204490|141635058|OTHER|||||||0.071|||||||t-test, 2 sided|||(FGBT% at 1 year of treatment minus FGBT% at baseline) divided by FGBT% at baseline.||||0.071
71063327|NCT00204490|141635058|OTHER|||||||0.08|||||||t-test, 2 sided|||(FGBT% at 2 year of treatment minus FGBT% at baseline) divided by FGBT% at baseline.||||0.080
71110881|NCT02831855|141727416|SUPERIORITY||Difference in percentage of participants|-12.75|||||TWO_SIDED|95.0|-21.01|-4.48||||||Week 36||-4.48|-21.01|
71110882|NCT02831855|141727416|SUPERIORITY||Difference in percentage of participants|-11.99|||||TWO_SIDED|95.0|-20.22|-3.75||||||Week 48||-3.75|-20.22|
71110883|NCT02831855|141727417|SUPERIORITY||Difference in percentage of participants|-5.37|||||TWO_SIDED|95.0|-13.63|2.89||||||Week 36||2.89|-13.63|
71110884|NCT02831855|141727417|SUPERIORITY||Difference in percentage of participants|-4.97|||||TWO_SIDED|95.0|-13.32|3.36||||||Week 48||3.36|-13.32|
71110885|NCT02831855|141727418|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|0.02|0.16||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline HAQ-DI.||0.16|0.02|
71063328|NCT00204490|141635058|OTHER||Slope|-0.107|STANDARD_ERROR_OF_MEAN|0.045||0.019|TWO_SIDED||||||Regression, Linear|Mixed model|slope for interaction of treatment and time, placebo was the reference group; square root transformed outcome.|Intention to treat||||0.019
71063329|NCT02166333|141635061|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.54|TWO_SIDED|95.0|0.76|1.15||The P value is nominal and two-sided.|Log Rank||The Experience on Best Dose versus 200 IU/day hazard ratio and its 95% confidence interval were derived from a Cox regression model with dose group as the single model variable.|The Experience on Best Dose group includes all participants assigned or switched to best dose (1000 IU/day) and excludes 41 participants randomized to 2000 or 4000 IU/day who were never issued a bottle of best dose. For those randomized to 2000 or 4000 IU/day, at-risk time and events are measured from the date of their switch to best dose. 150 Experience on Best Dose participants (median follow-up, 10.2 mos) and 125 200 IU/day participants (median follow-up, 20.3 mos) were censored.||1.15|0.76|0.54
71110886|NCT02831855|141727418|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-0.06|0.09||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline HAQ-DI.||0.09|-0.06|
71110887|NCT02831855|141727419|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-1.79|0.92||||||Change at Week 36: Physical Functioning- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 physical component score as a covariate.||0.92|-1.79|
71110888|NCT02831855|141727419|SUPERIORITY||LS Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|95.0|-0.82|1.85||||||Change at Week 48: Physical Functioning- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 physical component score as a covariate.||1.85|-0.82|
71110889|NCT02831855|141727419|SUPERIORITY||LS Mean Difference|-1.67|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-2.97|-0.37||||||Change at Week 36: Role Physical Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 role physical score score as a covariate.||-0.37|-2.97|
71110890|NCT02831855|141727419|SUPERIORITY||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-2.13|0.66||||||Change at Week 48: Role Physical Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 role physical score score as a covariate.||0.66|-2.13|
71110891|NCT02831855|141727419|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-1.5|1.21||||||Change at Week 36: Social functioning- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 Social functioning score as a covariate.||1.21|-1.50|
71063330|NCT02166333|141635061|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.86|1.25|||||The comparison of the Pooled Higher Doses group versus the 200 IU/d group is a sensitivity analysis.|||1.25|0.86|
71063331|NCT02166333|141635062|SUPERIORITY|The overall P tests for difference between groups in differential change from baseline over time and is from a 3 degree of freedom test of the combined 3 treatment-by-time interaction terms from the longitudinal mixed effects model.||||||0.15||||||The P value is nominal and not adjusted for multiple comparisons.|Regression, Linear|3 degree of freedom interaction test||The two groups were assessed for differential change over time in change from baseline using a longitudinal mixed effects regression model with gait speed as the outcome and fixed effects including a single treatment term, 3 time point terms and 3 treatment-by-time interaction terms and a random intercept for participant.||||0.15
71063332|NCT00359424|141635088|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.5||||0.7031|TWO_SIDED|95.0|-6.1|9.1||The CMH statistic is tested at the two-sided alpha level of 0.05. For the interim analyses of the primary efficacy analysis, the alpha spending function method (Lan and DeMets, 1987) with O'Brien and Fleming (1979) stopping boundaries were adopted.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusting for the dichotomized baseline NIHSS score (\<20 or ≥20).|Positive adjusted risk difference indicates greater risk in the Endovascular group, while negative adjusted risk difference indicates greater risk in the IV Only group.|Test of null hypothesis (equal proportions of subjects with mRS of 0-2 at 90 days post-randomization in IV Only and Endovascular treatment arms) versus alternative hypothesis (unequal proportions of subjects with mRS of 0-2 at 90 days post-randomization in IV Only and Endovascular treatment arms).||9.1|-6.1|.7031
71063333|NCT00359424|141635089|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.0||||0.5241|TWO_SIDED|99.0|-10.3|6.2||The CMH statistic is tested at the two-sided alpha level of 0.01.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusting for the dichotomized baseline NIHSS score (\<20 or ≥20).|Positive adjusted risk difference indicates greater risk in the Endovascular group, while negative adjusted risk difference indicates greater risk in the IV Only group.|Test of null hypothesis (equal proportions of subjects with mortality within 90 days post-randomization in IV Only and Endovascular treatment arms) versus alternative hypothesis (unequal proportions of subjects with mortality within 90 days post-randomization in IV Only and Endovascular treatment arms).||6.2|-10.3|.5241
71063334|NCT00359424|141635090|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.4||||0.8275|TWO_SIDED|99.0|-4.6|5.5||The CMH statistic is tested at the two-sided alpha level of 0.01.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusting for the dichotomized baseline NIHSS score (\<20 or ≥20).|Positive adjusted risk difference indicates greater risk in the Endovascular group, while negative adjusted risk difference indicates greater risk in the IV Only group.|Test of null hypothesis (equal proportions of subjects with sICH within 30 hours post IV tPA initiation in IV Only and Endovascular treatment arms) versus alternative hypothesis (unequal proportions of subjects with sICH within 30 hours post IV tPA initiation in IV Only and Endovascular treatment arms).||5.5|-4.6|.8275
71063335|NCT03655405|141635135|SUPERIORITY||Incidence Rate Ratio|0.972||||0.723|TWO_SIDED|95.0|0.83|1.138|||Regression, Poisson|Number of PIMs at follow-up, adjusted for baseline value||||1.138|0.830|0.723
71063336|NCT03655405|141635136|SUPERIORITY||Incidence Rate Ratio|0.763||||0.033|TWO_SIDED|95.0|0.594|0.979|||Regression, Poisson|Number of potentially inappropriate DDD at follow-up, adjusted for baseline value||||0.979|0.594|0.033
71063337|NCT03655405|141635137|SUPERIORITY||Incidence Rate Ratio|0.915||||0.064|TWO_SIDED|95.0|0.834|1.005|||Regression, Poisson|Number of chronic drugs at follow-up, adjusted for baseline value||||1.005|0.834|0.064
71110892|NCT02831855|141727419|SUPERIORITY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-1.95|0.93||||||Change at Week 48: Social functioning- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 Social functioning score as a covariate.||0.93|-1.95|
71110893|NCT02831855|141727419|SUPERIORITY||LS Mean Difference|-1.45|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|95.0|-2.9|-0.01||||||Change at Week 36: Bodily Pain Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 bodily pain score as a covariate.||-0.01|-2.90|
71110894|NCT02831855|141727419|SUPERIORITY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-2.23|0.73||||||Change at Week 48: Bodily Pain Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 bodily pain score as a covariate.||0.73|-2.23|
71110895|NCT02831855|141727419|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.71|||TWO_SIDED|95.0|-2.29|0.49||||||Change at Week 36: Mental Health Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 mental health score as a covariate.||0.49|-2.29|
71110896|NCT02831855|141727419|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-1.94|1.02||||||Change at Week 48: Mental Health Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 mental health score as a covariate.||1.02|-1.94|
71110897|NCT02831855|141727419|SUPERIORITY||LS Mean Difference|-1.11|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|95.0|-2.64|0.43||||||Change at Week 36: Role Emotional Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 role emotional score as a covariate.||0.43|-2.64|
71063338|NCT03655405|141635138|SUPERIORITY||Incidence Rate Ratio|1.019||||0.857|TWO_SIDED|95.0|0.833|1.246|||Regression, Poisson|Number of chronic drugs at follow-up, adjusted for baseline value||||1.246|0.833|0.857
71063339|NCT03655405|141635140|SUPERIORITY||Slope|-1.36||||0.769|TWO_SIDED|95.0|-10.6|7.89|||Regression, Linear|Scale value at follow-up, adjusted for baseline value||Analysis for the scale component||7.89|-10.60|0.769
71110898|NCT02831855|141727419|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-1.95|1.01||||||Change at Week 48: Role Emotional Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 role emotional score as a covariate.||1.01|-1.95|
71110899|NCT02831855|141727419|SUPERIORITY||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-2.52|0.22||||||Change at Week 36: Vitality Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 vitality score as a covariate.||0.22|-2.52|
70937338|NCT00113529|141374726|SUPERIORITY_OR_OTHER|||||||0.834||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.834
70937339|NCT00113529|141374726|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||1.000
70937340|NCT00113529|141374726|SUPERIORITY_OR_OTHER|||||||0.332||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.332
70937341|NCT00113529|141374727|SUPERIORITY_OR_OTHER|||||||0.473||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.473
70937342|NCT00113529|141374727|SUPERIORITY_OR_OTHER|||||||0.286||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.286
70937343|NCT00113529|141374727|SUPERIORITY_OR_OTHER|||||||0.277||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.277
70937344|NCT00113529|141374727|SUPERIORITY_OR_OTHER|||||||0.956||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.956
70937345|NCT00113529|141374727|SUPERIORITY_OR_OTHER|||||||0.278||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.278
70937346|NCT00113529|141374728|SUPERIORITY_OR_OTHER|||||||0.275||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.275
70937347|NCT00113529|141374728|SUPERIORITY_OR_OTHER|||||||0.227||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.227
70937348|NCT00113529|141374728|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.029
71063340|NCT03655405|141635140|SUPERIORITY||Slope|-0.096||||0.075|TWO_SIDED|95.0|-0.202|0.01|||Regression, Linear|Scale value at follow-up, adjusted for baseline value||Analysis for the index component||0.01|-0.202|0.075
71063341|NCT03655405|141635141|SUPERIORITY||Incidence Rate Ratio|1.237||||0.212|TWO_SIDED|95.0|0.886|1.727|||Mixed-effect regression, Poisson|Number at follow-up, adjusted for baseline value||||1.727|0.886|0.212
71063342|NCT03655405|141635142|SUPERIORITY||p-value|0.675||||0.675|TWO_SIDED||||||Fisher Exact|||||||0.675
71110900|NCT02831855|141727419|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-1.94|0.91||||||Change at Week 48: Vitality Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 vitality score as a covariate.||0.91|-1.94|
71110901|NCT02831855|141727419|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-1.3|1.08||||||Change at Week 36: General Health Perception Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 general health perception score as a covariate.||1.08|-1.30|
70937349|NCT00113529|141374728|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||1.000
71063343|NCT03655405|141635143|SUPERIORITY||p-value|0.615||||0.615|TWO_SIDED||||||Fisher Exact|||||||0.615
71063344|NCT03655405|141635144|SUPERIORITY||p-value|0.366||||0.366|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.366
71063345|NCT03655405|141635145|SUPERIORITY||p-value|0.738||||0.738|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.738
71063346|NCT03655405|141635146|SUPERIORITY||p-value|0.781||||0.781|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.781
70937350|NCT00113529|141374728|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||1.000
70937351|NCT00113529|141374729|SUPERIORITY_OR_OTHER|||||||0.435||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.435
70937352|NCT00113529|141374729|SUPERIORITY_OR_OTHER|||||||0.722||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.722
70937353|NCT00113529|141374729|SUPERIORITY_OR_OTHER|||||||0.645||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.645
70937354|NCT00113529|141374729|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.140
70937355|NCT00113529|141374729|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.046
70937356|NCT00113529|141374730|SUPERIORITY_OR_OTHER|||||||0.734||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.734
70937357|NCT00113529|141374730|SUPERIORITY_OR_OTHER|||||||0.854||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.854
70937358|NCT00113529|141374730|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.230
70937359|NCT00113529|141374730|SUPERIORITY_OR_OTHER|||||||0.067||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.067
70937360|NCT00113529|141374730|SUPERIORITY_OR_OTHER|||||||0.164||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.164
70937361|NCT00113529|141374730|SUPERIORITY_OR_OTHER|||||||0.121||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.121
70937362|NCT00113529|141374731|SUPERIORITY_OR_OTHER|||||||0.734||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.734
70937363|NCT00113529|141374731|SUPERIORITY_OR_OTHER|||||||0.462||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.462
70937364|NCT00113529|141374731|SUPERIORITY_OR_OTHER|||||||0.423||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.423
70937365|NCT00113529|141374731|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.510
70937366|NCT00113529|141374731|SUPERIORITY_OR_OTHER|||||||0.608||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.608
70937367|NCT00113529|141374731|SUPERIORITY_OR_OTHER|||||||0.121||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.121
70937368|NCT00113529|141374732|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.910
70937369|NCT00113529|141374732|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.020
70937370|NCT00113529|141374732|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||1.000
70937371|NCT00113529|141374732|SUPERIORITY_OR_OTHER|||||||0.509||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.509
70937372|NCT00113529|141374732|SUPERIORITY_OR_OTHER|||||||0.883||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.883
70937373|NCT00113529|141374732|SUPERIORITY_OR_OTHER|||||||0.582||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.582
70937374|NCT00113529|141374733|SUPERIORITY_OR_OTHER|||||||0.428||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.428
70937375|NCT00113529|141374733|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.075
70937376|NCT00113529|141374733|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||1.000
70937377|NCT00113529|141374733|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.019
71110902|NCT02831855|141727419|SUPERIORITY||LS Mean Difference|0.62|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-0.6|1.83||||||Change at Week 48: General Health Perception Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 general health perception score as a covariate.||1.83|-0.60|
71110903|NCT02831855|141727420|SUPERIORITY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-2.01|0.37||||||Change at Week 36: Physical Component Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 physical component score- as a covariate.||0.37|-2.01|
71110904|NCT02831855|141727420|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-1.11|1.29||||||Change at Week 48: Physical Component Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a biological disease-modifying anti-rheumatic drug (DMARD), and baseline SF-36 physical component score- as a covariate.||1.29|-1.11|
71110905|NCT02831855|141727420|SUPERIORITY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|95.0|-2.13|0.49||||||Change at Week 36: Mental Component Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 mental component score as a covariate.||0.49|-2.13|
70852581|NCT02123251|141194061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.787|STANDARD_ERROR_OF_MEAN|28.5519||0.5333|TWO_SIDED|95.0|-73.7478|38.1737|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||38.1737|-73.7478|0.5333
70937378|NCT00113529|141374733|SUPERIORITY_OR_OTHER|||||||0.124||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.124
70937379|NCT00113529|141374733|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.055
70937380|NCT00113529|141374734|SUPERIORITY_OR_OTHER|||||||0.734||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.734
71063347|NCT03655405|141635147|SUPERIORITY||p-value|0.958||||0.958|TWO_SIDED||||||Fisher Exact|||||||0.958
71063348|NCT03655405|141635148|SUPERIORITY||p-value|0.911||||0.911|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.911
71063349|NCT01445730|141635177|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
71063350|NCT01445730|141635178|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
71063351|NCT01445730|141635179|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
71063352|NCT01445730|141635180|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
71063353|NCT01445730|141635181|OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||||||0.006
71063354|NCT01445730|141635182|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
71063355|NCT01445730|141635183|OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
71063356|NCT03805412|141635193|SUPERIORITY|||||||0.694|||||||t-test, 2 sided|||||||0.694
71110906|NCT02831855|141727420|SUPERIORITY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-2.06|0.7||||||Change at Week 48: Mental Component Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 mental component score as a covariate.||0.70|-2.06|
71110907|NCT02831855|141727421|SUPERIORITY||LS Mean Difference|1.61|STANDARD_ERROR_OF_MEAN|2.41|||TWO_SIDED|95.0|-3.14|6.37||||||Change at Week 36: Absenteeism Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI absenteeism score as a covariate.||6.37|-3.14|
70937381|NCT00113529|141374734|SUPERIORITY_OR_OTHER|||||||0.854||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.854
70937382|NCT00113529|141374734|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.230
70937383|NCT00113529|141374734|SUPERIORITY_OR_OTHER|||||||0.067||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.067
70937384|NCT00113529|141374734|SUPERIORITY_OR_OTHER|||||||0.164||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.164
70937385|NCT00113529|141374734|SUPERIORITY_OR_OTHER|||||||0.121||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.121
70937386|NCT00113529|141374735|SUPERIORITY_OR_OTHER|||||||0.734||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.734
70937387|NCT00113529|141374735|SUPERIORITY_OR_OTHER|||||||0.462||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.462
70937388|NCT00113529|141374735|SUPERIORITY_OR_OTHER|||||||0.423||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.423
70937389|NCT00113529|141374735|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.510
70937390|NCT00113529|141374735|SUPERIORITY_OR_OTHER|||||||0.608||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.608
70937391|NCT00113529|141374735|SUPERIORITY_OR_OTHER|||||||0.121||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.121
70937392|NCT00113529|141374736|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.910
70937393|NCT00113529|141374736|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.020
70937394|NCT00113529|141374736|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||1.000
70937395|NCT00113529|141374736|SUPERIORITY_OR_OTHER|||||||0.509||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.509
70937396|NCT00113529|141374736|SUPERIORITY_OR_OTHER|||||||0.883||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.883
71063357|NCT01465412|141635194|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the least squares mean (LSM) Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.075|||||TWO_SIDED|90.0|0.695|1.662||||||The analysis was performed using an analysis of covariance (ANCOVA) model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, Body Mass Index (BMI) and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||1.662|0.695|
71063358|NCT01465412|141635194|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|2.598|||||TWO_SIDED|90.0|1.334|5.06||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||5.060|1.334|
71063359|NCT01465412|141635195|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.305|||||TWO_SIDED|90.0|0.84|2.027||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||2.027|0.840|
70937397|NCT00113529|141374736|SUPERIORITY_OR_OTHER|||||||0.582||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.582
70937398|NCT00113529|141374737|SUPERIORITY_OR_OTHER|||||||0.428||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.428
70937399|NCT00113529|141374737|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.075
71063360|NCT01465412|141635195|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.434|||||TWO_SIDED|90.0|0.643|3.198||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||3.198|0.643|
71063361|NCT01465412|141635196|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.852|||||TWO_SIDED|90.0|0.81|4.234||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||4.234|0.810|
71063362|NCT01465412|141635196|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|2.392|||||TWO_SIDED|90.0|1.306|4.382||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||4.382|1.306|
71063363|NCT01465412|141635197|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.548|||||TWO_SIDED|90.0|0.918|2.61||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||2.610|0.918|
71063364|NCT01465412|141635197|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.407|||||TWO_SIDED|90.0|0.72|2.75||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||2.750|0.720|
70937400|NCT00113529|141374737|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||1.000
70937401|NCT00113529|141374737|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.019
70937402|NCT00113529|141374737|SUPERIORITY_OR_OTHER|||||||0.124||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.124
70937403|NCT00113529|141374737|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.055
70937404|NCT00795639|141374755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.0||||0.0104|TWO_SIDED|95.0|3.0|26.0||Significance test performed using non-parametric analysis of covariance controlling for Baseline 6MWD and PAH etiology and PAH not secondary to a connective tissue disease (other).|ANCOVA||Missing value at Week 12 assigned as zero if the subject had a predefined clinical worsening event, otherwise, missing value at Week 12 imputed with the last non-missing 6MWD based on LOCF.|||26|3|0.0104
70937405|NCT00795639|141374756|SUPERIORITY_OR_OTHER|||||||0.2908|TWO_SIDED|||||Significance tests of WHO Functional Class performed using the Cochran-Mantel-Haenszel (CMH) test, stratified by Baseline 6MWD (less than 310 meters and greater than or equal to 310 meters) and PAH Etiology (Connective Tissue Disease and others).|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores, and the p-value corresponding to ANCOVA (row mean scores) statistics were used.||Week 12||||0.2908
71063365|NCT01465412|141635198|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.555|||||TWO_SIDED|90.0|0.617|3.917||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||3.917|0.617|
71063366|NCT01465412|141635198|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|4.806|||||TWO_SIDED|90.0|2.77|8.335||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||8.335|2.770|
71063367|NCT01465412|141635199|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.269|||||TWO_SIDED|90.0|0.703|2.288||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||2.288|0.703|
71063368|NCT01465412|141635199|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.98|||||TWO_SIDED|90.0|1.316|2.977||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||2.977|1.316|
71063369|NCT01465412|141635200|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.326|||||TWO_SIDED|90.0|0.749|2.348||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||2.348|0.749|
71063370|NCT01465412|141635200|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|4.041|||||TWO_SIDED|90.0|1.46|11.187||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||11.187|1.460|
71078122|NCT01026818|141664587|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.53|STANDARD_ERROR_OF_MEAN|1.34||0.692|TWO_SIDED|95.0|-3.16|2.1||P-value is for Hormonal - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.10|-3.16|0.692
70937406|NCT01138657|141374789|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.36|0.7|||Log Rank|||The primary analysis of the primary endpoint was performed on Main Study data, excluding the Japanese sub-study. The statistical test was performed at a 2-sided significance level of 0.05. The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment as factor.||0.70|0.36|<0.001
71078123|NCT01026818|141664587|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.09|STANDARD_ERROR_OF_MEAN|1.3||0.943|TWO_SIDED|95.0|-2.65|2.46||P-value is for Hormonal - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.46|-2.65|0.943
71078124|NCT01026818|141664588|SUPERIORITY_OR_OTHER||LS Mean Differences|4.2|STANDARD_ERROR_OF_MEAN|1.89||0.028|TWO_SIDED|95.0|0.47|7.93||P-value is for length.|ANCOVA|ANCOVA model included terms for treatment, baseline, age group and country.||||7.93|0.47|0.028
70937407|NCT01138657|141374789|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.56|||<|0.001|TWO_SIDED|95.0|0.4|0.76|||Log Rank|||An additional analysis of the primary endpoint was performed using the Integrated Study data (Main Study + Japan sub-study). The statistical test was performed at a 2-sided significance level of 0.05. The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment and race (Japanese versus non-Japanese) as factors.||0.76|0.40|< 0.001
71078125|NCT01026818|141664588|SUPERIORITY_OR_OTHER||LS Mean Differences|-1.53|STANDARD_ERROR_OF_MEAN|1.87||0.413|TWO_SIDED|95.0|-5.2|2.14||P-value is for length.|ANCOVA|ANCOVA model included terms for treatment, baseline, age group and country.||||2.14|-5.20|0.413
70941754|NCT04748445|141383935|OTHER||Slope|0.00184|STANDARD_ERROR_OF_MEAN|7.343||0.0135|TWO_SIDED|90.0|0.0006233|0.003057|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.003057|0.0006233|0.0135
71063371|NCT01465412|141635201|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.609|||||TWO_SIDED|90.0|1.007|2.572||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||2.572|1.007|
70941755|NCT04748445|141383935|OTHER||Slope|0.00129|STANDARD_ERROR_OF_MEAN|5.029||0.0115|TWO_SIDED|90.0|0.0004563|0.002123|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 05 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.002123|0.0004563|0.0115
71063372|NCT01465412|141635201|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|2.231|||||TWO_SIDED|90.0|0.844|5.896||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||5.896|0.844|
71063373|NCT04390113|141635202|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.6253|TWO_SIDED|95.0|0.55|1.55|||Log Rank|||||1.55|0.55|0.6253
71063374|NCT00030901|141635214|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||P-value is adjusted for stratification factors age older than 60, African American, baseline PSA, and vitamin E supplementation.|Regression, Logistic|||With target sample size of 466 randomized patients (233 per arm), there is a 90% of power to detect a one-third reduction in the three-year incidence rate of prostate cancer. The alpha level is set at 0.025, one-sided.||||0.73
71063375|NCT03817190|141635218|SUPERIORITY||Proportion of participants|-0.2277||||0.688|TWO_SIDED|95.0|-1.0415|0.586|||GLMM|||||0.5860|-1.0415|0.6880
71063376|NCT03817190|141635219|SUPERIORITY||Proportion of participants|-0.276||||0.4321|TWO_SIDED|95.0|-0.9185|0.3665|||GLMM|||||0.3665|-0.9185|0.4321
71063377|NCT04225715|141635331|SUPERIORITY||Difference in Response Rate|7.2|||||TWO_SIDED|95.0|-2.1|16.4|||||95% CI for difference of two proportions was calculated using Cochran-Mantel-Haenszel (CMH) method.|||16.4|-2.1|
71063378|NCT04225715|141635331|SUPERIORITY||Difference in Response Rate|3.5|||||TWO_SIDED|95.0|-3.1|10.0|||||95% CI for difference of two proportions was calculated using CMH method.|||10|-3.1|
71063379|NCT04225715|141635331|SUPERIORITY||Difference in Response Rate|24.3|||||TWO_SIDED|95.0|9.0|39.5|||||95% CI for difference of two proportions was calculated using CMH method.|||39.5|9|
71063380|NCT04225715|141635331|SUPERIORITY||Difference in Response Rate|12.3|||||TWO_SIDED|95.0|1.3|23.3|||||95% CI for difference of two proportions was calculated using CMH method.|||23.3|1.3|
71063381|NCT04225715|141635331|SUPERIORITY||Difference in Response Rate|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||95% CI for difference of two proportions was calculated using CMH method.|||0|0|
71063382|NCT04225715|141635331|SUPERIORITY||Difference in Response Rate|6.7|||||TWO_SIDED|95.0|-2.2|15.7|||||95% CI for difference of two proportions was calculated using CMH method.|||15.7|-2.2|
71063383|NCT04225715|141635332|SUPERIORITY||6.2|6.2|||||TWO_SIDED|95.0|-2.0|14.5|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 7: Week 24||14.5|-2|
71063384|NCT04225715|141635332|SUPERIORITY||Difference in Response Rate|13.4|||||TWO_SIDED|95.0|1.2|25.6|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 8: Week 36||25.6|1.2|
71063385|NCT04225715|141635332|SUPERIORITY||Difference in Response Rate|7.2|||||TWO_SIDED|95.0|-2.1|16.4|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 2: Week 48||16.4|-2.1|
71063386|NCT04225715|141635332|SUPERIORITY||Difference in Response Rate|3.5|||||TWO_SIDED|95.0|-3.1|10.0|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 3: Week 48||10|-3.1|
71063387|NCT04225715|141635332|SUPERIORITY||Difference in Response Rate|31.2|||||TWO_SIDED|95.0|14.7|47.6|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 4: Week 48||47.6|14.7|
71063388|NCT04225715|141635332|SUPERIORITY||Difference in Response Rate|18.4|||||TWO_SIDED|95.0|5.4|31.4|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 6: Week 48||31.4|5.4|
71063389|NCT04225715|141635332|SUPERIORITY||Difference in Response Rate|8.1|||||TWO_SIDED|95.0|-3.9|20.1|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 2: FUW 48||20.1|-3.9|
71063390|NCT04225715|141635332|SUPERIORITY||Difference in Response Rate|-2.7|||||TWO_SIDED|95.0|-8.1|2.7|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 3: FUW 48||2.7|-8.1|
71063391|NCT04225715|141635332|SUPERIORITY||Difference in Response Rate|14.6|||||TWO_SIDED|95.0|0.4|28.8|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 4: FUW 48||28.8|0.4|
71063392|NCT04225715|141635332|SUPERIORITY||Difference in Response Rate|9.5|||||TWO_SIDED|95.0|-2.5|21.5|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 6: FUW 48||21.5|-2.5|
71063393|NCT05251337|141635351|SUPERIORITY|||||||0.462|||||||Mixed Models Analysis|||||||0.462
71063394|NCT05251337|141635352|SUPERIORITY|||||||0.285|||||||Mixed Models Analysis|||||||0.285
71063395|NCT05251337|141635354|SUPERIORITY|||||||0.091|||||||t-test, 2 sided|||||||0.091
71063396|NCT00471081|141635371|SUPERIORITY||Percentage of subjects with hSBA titers|88.4|||||TWO_SIDED|95.0|81.9|93.2|||||Immunogenecity of GSK134612 was demonstrated if the lower limit (LL) of the 2-sided exact 95% confidence interval (CI) was higher than the pre-defined clinical limit of 80%.|To demonstrate the immunogenicity of GSK134612 administered on a 2-dose schedule at 9 and 12 months of age with respect to serum bactericidal assay using human complement (hSBA) titers ≥1:8 for each discrete N. meningitidis serogroup A.||93.2|81.9|
70937408|NCT01138657|141374790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.29||||0.011|TWO_SIDED|95.0|-0.51|-0.07|||ANOVA|ANOVA with treatment as factor adjusted for clustered observations (i.e., observations from each of the participant's eyes).|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.07|-0.51|0.011
70937409|NCT01138657|141374790|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.25||||0.019|TWO_SIDED|95.0|-0.46|-0.04|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations (from each of the participant's eyes).|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.04|-0.46|0.019
70937410|NCT01138657|141374791|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.27|||<|0.001|TWO_SIDED|95.0|-0.43|-0.11|||ANOVA|ANOVA with treatment as factor adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.11|-0.43|<0.001
70937411|NCT01138657|141374791|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.28|||<|0.001|TWO_SIDED|95.0|-0.43|-0.12|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.12|-0.43|<0.001
70937412|NCT01138657|141374792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.07||||0.003|TWO_SIDED|95.0|-0.11|-0.02|||ANOVA|ANOVA with treatment as factor adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.02|-0.11|0.003
70937413|NCT01138657|141374792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.06||||0.008|TWO_SIDED|95.0|-0.1|-0.02|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.02|-0.10|0.008
70937414|NCT01138657|141374793|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7||||0.231|TWO_SIDED|95.0|0.39|1.26|||Log Rank||The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment as factor.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||1.26|0.39|0.231
70937415|NCT01138657|141374793|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.68||||0.191|TWO_SIDED|95.0|0.38|1.21|||Log Rank||The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment and race (Japanese versus non-Japanese) as factors.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||1.21|0.38|0.191
70937416|NCT01138657|141374794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-11.4||||0.02|TWO_SIDED|95.0|-20.9|-1.8|||ANOVA|ANOVA with treatment and OCT machine as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-1.8|-20.9|0.020
70937417|NCT01138657|141374794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-5.1||||0.428|TWO_SIDED|95.0|-17.7|7.5|||Chi-squared, Corrected|ANOVA with treatment, race (Japanese versus non-Japanese) and OCT machine as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||7.5|-17.7|0.428
71110908|NCT02831855|141727421|SUPERIORITY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|2.28|||TWO_SIDED|95.0|-5.01|3.99||||||Change at Week 48: Absenteeism Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI absenteeism score as a covariate.||3.99|-5.01|
71110909|NCT02831855|141727421|SUPERIORITY||LS Mean Difference|3.19|STANDARD_ERROR_OF_MEAN|1.88|||TWO_SIDED|95.0|-0.51|6.89||||||Change at Week 36: Daily activity impairment- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI daily activity impairment score as a covariate.||6.89|-0.51|
71110910|NCT02831855|141727421|SUPERIORITY||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|2.04|||TWO_SIDED|95.0|-2.41|5.61||||||Change at Week 48: Daily activity impairment- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI daily activity impairment score as a covariate.||5.61|-2.41|
71110911|NCT02831855|141727421|SUPERIORITY||LS Mean Difference|3.01|STANDARD_ERROR_OF_MEAN|2.97|||TWO_SIDED|95.0|-2.84|8.87||||||Change at Week 36: Presenteeism- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI presenteeism score as a covariate.||8.87|-2.84|
71063397|NCT00471081|141635371|SUPERIORITY||Percentage of subjects with hSBA titers|100.0|||||TWO_SIDED|95.0|97.3|100.0|||||Immunogenecity of GSK134612 was demonstrated if the lower limit (LL) of the 2-sided exact 95% confidence interval (CI) was higher than the pre-defined clinical limit of 90%.|To demonstrate the immunogenicity of GSK134612 administered on a 2-dose schedule at 9 and 12 months of age with respect to serum bactericidal assay using human complement (hSBA) titers ≥1:8 for each discrete N. meningitidis serogroup C.||100|97.3|
71063398|NCT00471081|141635371|SUPERIORITY||Percentage of subjects with hSBA titers|99.3|||||TWO_SIDED|95.0|96.2|100.0|||||Immunogenecity of GSK134612 was demonstrated if the lower limit (LL) of the 2-sided exact 95% confidence interval (CI) was higher than the pre-defined clinical limit of 80%.|To demonstrate the immunogenicity of GSK134612 administered on a 2-dose schedule at 9 and 12 months of age with respect to serum bactericidal assay using human complement (hSBA) titers ≥1:8 for each discrete N. meningitidis serogroup W-135.||100|96.2|
71063399|NCT00471081|141635371|SUPERIORITY||Percentage of subjects with hSBA titers|99.3|||||TWO_SIDED|95.0|96.2|100.0|||||Immunogenecity of GSK134612 was demonstrated if the lower limit (LL) of the 2-sided exact 95% confidence interval (CI) was higher than the pre-defined clinical limit of 80%.|To demonstrate the immunogenicity of GSK134612 administered on a 2-dose schedule at 9 and 12 months of age with respect to serum bactericidal assay using human complement (hSBA) titers ≥1:8 for each discrete N. meningitidis serogroup Y.||100|96.2|
71063400|NCT04537078|141635395|OTHER||Median Difference (Final Values)|1.5||||0.254|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.254
71063401|NCT04537078|141635396|OTHER||Median Difference (Final Values)|9.48||||0.219|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.219
71063402|NCT04537078|141635397|OTHER||Median Difference (Final Values)|1.0||||0.269|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.269
71063403|NCT04537078|141635398|OTHER||Median Difference (Final Values)|0.0||||0.072|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.072
71063404|NCT04537078|141635399|OTHER|||||||1|||||||Fisher Exact|||||||1
71063405|NCT04537078|141635400|OTHER|||||||0.72|||||||Chi-squared|||||||0.720
71063406|NCT04537078|141635401|OTHER||Median Difference (Final Values)|2.0||||0.002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.002
71063407|NCT04537078|141635402|OTHER||Median Difference (Final Values)|600.0||||0.007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.007
71063408|NCT04537078|141635403|OTHER||Median Difference (Final Values)|2.0||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.001
71063409|NCT04537078|141635404|OTHER||Median Difference (Final Values)|33.33||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.04
71063410|NCT04537078|141635405|OTHER||Median Difference (Final Values)|2.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71063411|NCT04537078|141635406|OTHER||Median Difference (Final Values)|0.0||||0.851|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.851
71063412|NCT04537078|141635407|OTHER||Median Difference (Final Values)|25.0||||0.304|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.304
71063413|NCT04537078|141635408|OTHER||Median Difference (Final Values)|1.0||||0.486|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.486
71063414|NCT01568892|141635409|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.16|||<|0.001|TWO_SIDED|95.0|-1.52|-0.8|||ANCOVA||The estimated value represents the adjusted mean difference between the two treatment arms.|||-0.80|-1.52|<0.001
71063415|NCT01704495|141635460|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.56||||0.119|TWO_SIDED|90.0|0.98|2.49||2-sided p-value|Poisson regression|Correction for overdispersion made by Pearson chi-square|AZD5069 45 mg BID vs Placebo|||2.49|0.98|0.119
71063416|NCT01704495|141635460|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.53||||0.141|TWO_SIDED|90.0|0.95|2.46||2-sided|Poisson Regression|Correction for overdispersion made by Pearson chi-square|AZD5069 15 mg BID vs Placebo|||2.46|0.95|0.141
71063417|NCT01704495|141635460|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.29||||0.397|TWO_SIDED|90.0|0.79|2.11||2-sided|Poisson Regression|Correction for overdispersion made by Pearson chi-square|AZD5069 5 mg BID vs Placebo|||2.11|0.79|0.397
71063418|NCT00997373|141635503|SUPERIORITY_OR_OTHER|||||||0.0373|TWO_SIDED||||||Fisher Exact|||||||0.0373
71063419|NCT03810092|141635512|OTHER||Odds Ratio, log|-0.04||||0.05|TWO_SIDED|95.0|-0.55|0.42|||Regression, Linear|||Relationship between ADL score evolution and hemoglobine rate, in the no transfusion group||0.42|-0.55|0.05
71063420|NCT03810092|141635512|OTHER||Odds Ratio, log|0.39||||0.05|TWO_SIDED|95.0|-1.0|2.2|||Regression, Logistic|||Relationship between ADL score evolution and hemoglobine rate, in the transfusion group||2.2|-1|0.05
71063421|NCT03296527|141635526|NON_INFERIORITY|If the lower-limit of the two-sided 95% confidence interval (CI) was greater than the non-inferiority limit (-10.0%), the null hypothesis was rejected. In that case, it would be claimed that FE 999049 was non-inferior to GONAL-F with respect to ongoing pregnancy rate in women undergoing controlled ovarian stimulation.|Risk Difference (RD)|5.4|||||TWO_SIDED|95.0|-0.2|11.0|||||The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.|Percentage of participants with ongoing pregnancy rate||11.0|-0.2|
71063422|NCT03296527|141635527|OTHER||Risk Difference (RD)|6.3|||||TWO_SIDED|95.0|0.3|12.3|||||The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.|Percentage of participants with positive beta-hCG||12.3|0.3|
71078126|NCT01026818|141664588|SUPERIORITY_OR_OTHER||LS Mean Differences|2.37|STANDARD_ERROR_OF_MEAN|1.49||0.112|TWO_SIDED|95.0|-0.55|5.3||P-value is for girth.|ANCOVA|ANCOVA model included terms for treatment, baseline, age group and country.||||5.30|-0.55|0.112
71078127|NCT01026818|141664588|SUPERIORITY_OR_OTHER||LS Mean Differences|3.16|STANDARD_ERROR_OF_MEAN|1.46||0.031|TWO_SIDED|95.0|0.29|6.03||P-value is for girth.|ANCOVA|ANCOVA model included terms for treatment, baseline, age group and country.||||6.03|0.29|0.031
71078128|NCT03543176|141664602|OTHER|||||||0.448||||||P-value for low impact of COPD is presented|Fisher Exact|||||||0.448
71078129|NCT03543176|141664602|OTHER|||||||0.033||||||P-value for medium impact of COPD is presented|Fisher Exact|||||||0.033
71078130|NCT03543176|141664602|OTHER|||||||0.172||||||P-value for high impact of COPD is presented|Fisher Exact|||||||0.172
71078131|NCT03543176|141664602|OTHER|||||||0.01||||||P-value for very high impact of COPD is presented|Fisher Exact|||||||0.010
71078132|NCT03543176|141664603|OTHER|||||||0.176||||||P-value for breathlessness reported in COPD assessed using mMRC is presented|Fisher Exact|||||||0.176
71063423|NCT03296527|141635528|OTHER||Risk Difference (RD)|4.9|||||TWO_SIDED|95.0|-0.9|10.7|||||The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.|Percentage of participants with at least one gestational sac 5-6 weeks after transfer||10.7|-0.9|
71063424|NCT03296527|141635529|OTHER||Risk Difference (RD)|4.2|||||TWO_SIDED|95.0|-1.5|9.8|||||The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.|Percentage of participants with at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer||9.8|-1.5|
70937418|NCT01138657|141374795|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|4.2||||0.01|TWO_SIDED|95.0|1.02|7.38|||ANOVA|ANOVA with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||7.38|1.02|0.010
71063425|NCT03296527|141635530|OTHER||Risk Difference (RD)|3.9|||||TWO_SIDED|95.0|-1.6|9.5|||||The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.|Percentage of implanted embryos 5-6 weeks after transfer||9.5|-1.6|
71078133|NCT03543176|141664604|OTHER|||||||0.732||||||P-value for Baseline comorbidity burden score was calculated.|t-test, 2 sided|||||||0.732
71078134|NCT03543176|141664605|OTHER|||||||0.013||||||P-value for count of unique medications was calculated.|t-test, 2 sided|||||||0.013
71078135|NCT03543176|141664606|OTHER|||||||0.178||||||P-value for total number of medications dispensing was calculated.|t-test, 2 sided|||||||0.178
71078136|NCT03543176|141664612|OTHER|||||||0.692||||||P-value for count of unique COPD medications was calculated|t-test, 2 sided|||||||0.692
71078137|NCT03543176|141664613|OTHER||||||<|0.001||||||P-value for total number of COPD medications dispensing was calculated|t-test, 2 sided|||||||<0.001
71078138|NCT03300050|141664634|OTHER||GMT Ratio|2.73|||<|0.0001|TWO_SIDED|95.0|1.73|4.29|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Adjusted Geometric Mean Titer (GMT) Ratio 28 Days Post-Boost Dose||4.29|1.73|<0.0001
71078139|NCT03300050|141664634|OTHER||GMT Ratio|1.06||||0.9411|TWO_SIDED|95.0|0.68|1.66|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||1.66|0.68|0.9411
71078140|NCT03300050|141664634|OTHER||GMT Ratio|0.39|||<|0.0001|TWO_SIDED|95.0|0.24|0.62|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||0.62|0.24|<0.0001
71078141|NCT03300050|141664635|OTHER||Difference|59.6||||0.0025|TWO_SIDED|95.0|23.59|81.02|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||81.02|23.59|0.0025
71078142|NCT03300050|141664635|OTHER||Difference|17.9||||0.4421|TWO_SIDED|95.0|-16.24|49.0|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||49.00|-16.24|0.4421
71078143|NCT03300050|141664635|OTHER||Difference|-41.8||||0.0461|TWO_SIDED|95.0|-68.75|-4.8|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||-4.80|-68.75|0.0461
71078144|NCT03300050|141664639|OTHER||GMT Ratio|1.71||||0.1665|TWO_SIDED|95.0|0.84|3.48|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgA (Serum) Humoral Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||3.48|0.84|0.1665
71078145|NCT03300050|141664639|OTHER||GMT Ratio|1.1||||0.9377|TWO_SIDED|95.0|0.55|2.2|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgA (Serum) Humoral Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||2.20|0.55|0.9377
71078146|NCT03300050|141664639|OTHER||GMT Ratio|0.64||||0.3088|TWO_SIDED|95.0|0.31|1.33|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||1.33|0.31|0.3088
71078147|NCT03300050|141664640|OTHER||Difference|16.3||||0.4667|TWO_SIDED|95.0|-19.85|48.88|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||48.88|-19.85|0.4667
71078148|NCT03300050|141664640|OTHER||Difference|-1.8|||>|0.9999|TWO_SIDED|95.0|-34.76|32.17|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||32.17|-34.76|>0.9999
71078149|NCT03300050|141664640|OTHER||Difference|-18.1||||0.4495|TWO_SIDED|95.0|-51.15|19.37|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||19.37|-51.15|0.4495
71078150|NCT03300050|141664644|OTHER||GMT Ratio|1.61||||0.0928|TWO_SIDED|95.0|0.94|2.77|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Adjusted GMT Ratio 28 Days Post-Boost Dose||2.77|0.94|0.0928
71078151|NCT03300050|141664644|OTHER||GMT Ratio|1.32||||0.4198|TWO_SIDED|95.0|0.77|2.26|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Adjusted GMT Ratio 28 Days Post-Boost Dose||2.26|0.77|0.4198
71110912|NCT02831855|141727421|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|3.77|||TWO_SIDED|95.0|-8.34|6.54||||||Change at Week 48: Presenteeism- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI presenteeism score as a covariate.||6.54|-8.34|
71110913|NCT02831855|141727421|SUPERIORITY||LS Mean Difference|2.84|STANDARD_ERROR_OF_MEAN|3.45|||TWO_SIDED|95.0|-3.97|9.65||||||Change at Week 36: Work productivity loss- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI work productivity loss score as a covariate.||9.65|-3.97|
71110914|NCT02831855|141727421|SUPERIORITY||LS Mean Difference|-2.46|STANDARD_ERROR_OF_MEAN|4.19|||TWO_SIDED|95.0|-10.72|5.8||||||Change at Week 48: Work productivity loss- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI work productivity loss score as a covariate.||5.80|-10.72|
71110915|NCT02831855|141727422|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.07|-0.01||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline EQ-5D score as a covariate.||-0.01|-0.07|
71110916|NCT02831855|141727422|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.06|0.01||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline EQ-5D score as a covariate.||0.01|-0.06|
71110917|NCT02831855|141727423|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-1.37|1.0||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline FACIT - fatigue scale score as a covariate.||1.00|-1.37|
71110918|NCT02831855|141727423|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.64|||TWO_SIDED|95.0|-1.07|1.44||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline FACIT - fatigue scale score as a covariate.||1.44|-1.07|
71110919|NCT02831855|141727424|SUPERIORITY||Difference in percentage of participants|-10.02|STANDARD_ERROR_OF_MEAN|3.87|||TWO_SIDED|95.0|-17.61|-2.42||||||Week 36||-2.42|-17.61|
71110920|NCT02831855|141727424|SUPERIORITY||Difference in percentage of participants|-6.62|STANDARD_ERROR_OF_MEAN|3.89|||TWO_SIDED|95.0|-14.26|1.0||||||Week 48||1.00|-14.26|
71110921|NCT01803880|141727436|NON_INFERIORITY|"Non-inferiority Margin = 10 points. Non-inferiority of study device was concluded if lower limit of one-sided 97.5% CI for treatment difference \<10.~Superiority of study device was established if LS means of treatment difference and lower limit of one-sided 97.5% CI for treatment difference ≤0."|One-sided 97.5% confidence interval (CI)|-7.42|STANDARD_ERROR_OF_MEAN|5.137|>|0.05|ONE_SIDED|97.5|-19.29|||All unscheduled visits were to be included and nominal visits were to be applied using analysis visit windows. Both the assigned analysis visits and the site reported nominal visits were provided in the subject data listings.|ANCOVA|Due to early termination, all inferential analysis was interpreted as descriptive and carried out in an exploratory manner.||An ANCOVA model was used to compare the difference in the devices for change from Baseline in the KOOS at Week 52. KOOS was derived as the average of five subscale scores. LOCF imputation was considered for missing value. One-sided 97.5% confidence interval (CI) for treatment difference (Study-Control) was to be used for determining non-inferiority/superiority of the study device.|||-19.29|>0.05
71110922|NCT01152788|141727485|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.1||||0.76|TWO_SIDED|95.0|0.6|2.01|||Log Rank|||||2.01|0.6|0.76
71110923|NCT01152788|141727486|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-18.7|16.8||||||||16.8|-18.7|
71110924|NCT01152788|141727487|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8||||0.55|TWO_SIDED|95.0|0.38|1.68|||Log Rank|||||1.68|0.38|0.55
71110925|NCT01152788|141727488|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||Chi-squared|||||||0.01
71110926|NCT00889707|141727491|SUPERIORITY_OR_OTHER|||||||0.04||||||Test of superiority computed using an ANCOVA model with terms for treatment group, baseline total IPSS, and baseline prostate volume. Tested for 2-sided 0.05 level of statistical significance.|ANCOVA|ANCOVA model with terms for treatment group, baseline total IPSS, and baseline prostate volume.||||||0.040
71110927|NCT00889707|141727492|SUPERIORITY_OR_OTHER|||||||0.047||||||ANCOVA model with terms for treatment group, baseline total IPSS, baseline prostate volume, and baseline Qmax.|ANCOVA|Model with terms for treatment group, baseline total IPSS, baseline prostate volume, and baseline Qmax.||||||0.047
71110928|NCT01445847|141727578|SUPERIORITY_OR_OTHER||Percentage|5.0|||<|0.05|TWO_SIDED|95.0|1.7|9.1|||Comparison of proportions|||We used incidence reported to AIMS study to calculate the sample size of this study. We set the null hypothesis as (percentage point of laryngospasm incidence in placebo group (µ1) - percentage point of laryngospasm incidence in Lidocaine group (µ2) = 0), with alternative hypothesis is (µ1 \> µ2) by 5% was analyzed by comparison of two proportions. A sample size of 380 patients (190 per group) was adequate to detect a 5-percentage point difference in the incidence with 80% power and p = 0.05.||9.1|1.7|<0.05
71110929|NCT00125788|141727579|SUPERIORITY|||||||0.076|||||||Cochran-Mantel-Haenszel|||||||0.076
71110930|NCT00125788|141727580|SUPERIORITY|||||||0.072|||||||Cochran-Mantel-Haenszel|||||||0.072
71110931|NCT00125788|141727581|SUPERIORITY|||||||0.129|||||||Cochran-Mantel-Haenszel|||||||0.129
71110932|NCT02628444|141727643|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% confidence interval (CI) of the ratio of GMTs between groups (Group 2/Group 1) was greater than (\>) 1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|1.09|||||TWO_SIDED|95.0|0.862|1.39||||||Group 2/Group 1: Serotype 1||1.39|0.862|
71110933|NCT02628444|141727643|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.993|||||TWO_SIDED|95.0|0.82|1.2||||||Group 2/Group 1: Serotype 2||1.20|0.820|
71110934|NCT02628444|141727643|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.983|||||TWO_SIDED|95.0|0.816|1.18||||||Group 2/Group 1: Serotype 3||1.18|0.816|
70852582|NCT02123251|141194062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9097|STANDARD_ERROR_OF_MEAN|5.2351||0.862|TWO_SIDED|95.0|-9.3509|11.1702|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||11.1702|-9.3509|0.8620
70852583|NCT02123251|141194063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7177|STANDARD_ERROR_OF_MEAN|1.0433||0.4915|TWO_SIDED|95.0|-1.3272|2.7626|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||2.7626|-1.3272|0.4915
70852584|NCT02123251|141194064|SUPERIORITY_OR_OTHER||||||>|0.05|||||||standard diffs-in-diffs model|||A standard diffs-in-diffs model was utilized to estimate the causal effect of the intervention on medical costs per patient/day. The average change in cost over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no difference in the cost per patient per day from baseline to endpoint between groups.||||>0.05
70852585|NCT02123251|141194065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6403|STANDARD_ERROR_OF_MEAN|0.3148||0.042|TWO_SIDED|95.0|0.0233|1.2572|||Generalized Estimating Equation Model||The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|The average change in scores over time for the intervention group was compared to that for the control group. The difference in these average changes is referred to as the difference-in-differences values which was assessed for significance at p = 0.05. Null hypothesis assumed no difference in the General Diet subscale from baseline to endpoint between groups. Generalized estimating equation modeling was used to examine changes in SDSCA between groups at different time points.||1.2572|0.0233|0.0420
71063426|NCT03296527|141635531|OTHER||Risk Difference (RD)|4.4|||||TWO_SIDED|95.0|-0.9|9.7|||||The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.|Percentage of participants with ongoing implantation rate||9.7|-0.9|
71063427|NCT03296527|141635532|SUPERIORITY|Logistic regression including AMH group as a factor.|Odds Ratio (OR)|0.79||||0.083|TWO_SIDED|95.0|0.6|1.03||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with \<4 or \>=15 oocytes retrieved||1.03|0.60|0.083
71063428|NCT03296527|141635532|OTHER|Logistic regression including AMH group as a factor.|Odds Ratio (OR)|0.89||||0.489|TWO_SIDED|95.0|0.65|1.23||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with \<4 or \>=20 oocytes retrieved||1.23|0.65|0.489
71063429|NCT03296527|141635533|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.6||||0.075|TWO_SIDED|95.0|0.34|1.06||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with early OHSS (any grade)||1.06|0.34|0.075
71063430|NCT03296527|141635533|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.75||||0.365|TWO_SIDED|95.0|0.4|1.4||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with early OHSS (moderate/severe)||1.40|0.40|0.365
71063431|NCT03296527|141635533|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.33||||0.012|TWO_SIDED|95.0|0.13|0.83||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with any preventive intervention||0.83|0.13|0.012
71063432|NCT03296527|141635533|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.49||||0.004|TWO_SIDED|95.0|0.3|0.81||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with early OHSS (any grade) and/or preventive interventions||0.81|0.30|0.004
71063433|NCT03296527|141635533|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.56||||0.029|TWO_SIDED|95.0|0.33|0.95|||Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with early OHSS (moderate/severe) and/or preventive interventions||0.95|0.33|0.029
71063434|NCT03296527|141635534|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|4.58||||0.002|TWO_SIDED|95.0|1.52|13.74||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with cycle cancellation due to poor response||13.74|1.52|0.002
71063435|NCT03296527|141635534|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.39|||<|0.001|TWO_SIDED|95.0|0.24|0.62||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with transfer cancellation due to excessive ovarian response/OHSS risk||0.62|0.24|<0.001
71063436|NCT03296527|141635534|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.62||||0.02|TWO_SIDED|95.0|0.42|0.93||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with cycle cancellation due to poor or excessive response, or transfer cancellation due to excessive response/OHSS risk||0.93|0.42|0.020
71063437|NCT03296527|141635535|SUPERIORITY||||||<|0.001||||||2-sided|van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 10 mm||||<.001
70937419|NCT01138657|141374795|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|3.67||||0.019|TWO_SIDED|95.0|0.62|6.71|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||6.71|0.62|0.019
71063438|NCT03296527|141635535|SUPERIORITY||||||<|0.001||||||2-sided|van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 12 mm||||<.001
71063439|NCT03296527|141635535|SUPERIORITY|||||||0.568||||||2-sided|van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 15 mm||||0.568
71063440|NCT03296527|141635535|SUPERIORITY|||||||0.839||||||2-sided|van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 17 mm||||0.839
71063441|NCT03296527|141635536|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 10 mm||||<.001
71063442|NCT03296527|141635536|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 12 mm||||<.001
71063443|NCT03296527|141635536|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 15 mm||||<.001
71063444|NCT03296527|141635536|SUPERIORITY|||||||0.011|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 17 mm||||0.011
71063445|NCT03296527|141635537|SUPERIORITY|||||||0.14|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Largest follicle (mm)||||0.140
71063446|NCT03296527|141635537|SUPERIORITY|||||||0.155|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Average follicle size (mm)||||0.155
71063447|NCT03296527|141635537|SUPERIORITY|||||||0.159|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Treatment comparison: Average size of 3 largest follicles (mm)||||0.159
71063448|NCT03296527|141635538|SUPERIORITY|||||||0.848|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Largest follicle (mm)||||0.848
71063449|NCT03296527|141635538|SUPERIORITY|||||||0.629|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Average follicle size (mm)||||0.629
71063450|NCT03296527|141635538|SUPERIORITY|||||||0.768|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Average size of 3 largest follicles (mm)||||0.768
70937420|NCT01138657|141374796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|1.86||||0.346|TWO_SIDED|95.0|-2.03|5.75|||ANOVA|ANOVA with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||5.75|-2.03|0.346
71063451|NCT03296527|141635539|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Mean number of oocytes retrieved||||<.001
71063452|NCT03296527|141635541|SUPERIORITY|||||||0.197|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Percentage of MII oocytes / oocytes retrieved||||0.197
71063453|NCT03296527|141635542|SUPERIORITY|||||||0.79|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Fertilization rate relative to oocytes retrieved||||0.790
71063454|NCT03296527|141635543|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of embryos on day 3||||<.001
71063455|NCT03296527|141635543|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of good-quality embryos on Day 3||||<.001
71063456|NCT03296527|141635544|SUPERIORITY||Mean ratio|0.81|||<|0.001|TWO_SIDED|95.0|0.74|0.88||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of LH on stimulation Day 6||0.88|0.74|<0.001
70937421|NCT01138657|141374796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|1.31||||0.496|TWO_SIDED|95.0|-2.47|5.09|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||5.09|-2.47|0.496
70937422|NCT01138657|141374797|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|5.12||||0.036|TWO_SIDED|95.0|0.34|9.9|||ANOVA|ANOVA with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||9.90|0.34|0.036
70937423|NCT01138657|141374797|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|4.14||||0.077|TWO_SIDED|95.0|-0.45|8.72|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||8.72|-0.45|0.077
71063457|NCT03296527|141635545|SUPERIORITY||Mean ratio|0.9||||0.018|TWO_SIDED|95.0|0.82|0.98||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.||Circulating concentrations of LH at end-of-stimulation||0.98|0.82|0.018
71063458|NCT03296527|141635546|SUPERIORITY||Mean ratio|0.77|||<|0.001|TWO_SIDED|95.0|0.7|0.84||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Estradiol on stimulation Day 6||0.84|0.70|<0.001
71063459|NCT03296527|141635547|SUPERIORITY||Mean ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.68|0.81||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Estradiol at end-of-stimulation||0.81|0.68|<0.001
71063460|NCT03296527|141635548|SUPERIORITY||Mean Ratio|0.89||||0.003|TWO_SIDED|95.0|0.82|0.96||The p-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Progesterone on stimulation Day 6||0.96|0.82|0.003
71063461|NCT03296527|141635549|SUPERIORITY||Mean ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.68|0.79||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Progesterone at end-of-stimulation||0.79|0.68|<0.001
71063462|NCT03296527|141635550|SUPERIORITY||Mean ratio|0.76|||<|0.001|TWO_SIDED|95.0|0.7|0.83||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.||Circulating concentrations of Inhibin A on stimulation Day 6||0.83|0.70|<0.001
71063463|NCT03296527|141635551|SUPERIORITY||Mean ratio|0.77|||<|0.001|TWO_SIDED|95.0|0.71|0.83||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Inhibin A at end-of-stimulation||0.83|0.71|<0.001
71063464|NCT03296527|141635552|SUPERIORITY||Mean ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.77|0.89||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Inhibin B on stimulation Day 6||0.89|0.77|<0.001
71063465|NCT03296527|141635553|SUPERIORITY||Mean ratio|0.87||||0.001|TWO_SIDED|95.0|0.8|0.95||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Inhibin B at end-of-stimulation||0.95|0.80|0.001
70937424|NCT01138657|141374798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|10.02|||<|0.001|TWO_SIDED|95.0|4.86|15.19|||ANOVA|ANOVA with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||15.19|4.86|<0.001
70937425|NCT01138657|141374798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|8.83|||<|0.001|TWO_SIDED|95.0|3.88|13.79|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%||13.79|3.88|<0.001
71110935|NCT02628444|141727643|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.96|||||TWO_SIDED|95.0|0.809|1.14||||||Group 2/Group 1: Serotype 4||1.14|0.809|
71110936|NCT02628444|141727644|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|1.03|||||TWO_SIDED|95.0|0.757|1.4||||||Group 2/Group 1: Serotype 1||1.40|0.757|
71110937|NCT02628444|141727644|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.897|||||TWO_SIDED|95.0|0.705|1.14||||||Group 2/Group 1: Serotype 2||1.14|0.705|
71110938|NCT02628444|141727644|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.917|||||TWO_SIDED|95.0|0.724|1.16||||||Group 2/Group 1: Serotype 3||1.16|0.724|
71110939|NCT02628444|141727644|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.884|||||TWO_SIDED|95.0|0.72|1.09||||||Group 2/Group 1: Serotype 4||1.09|0.720|
71110940|NCT02628444|141727645|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|0.567|||||TWO_SIDED|98.75|0.399|0.805||||||Group 1a Booster/Group 1 Post-dose 3: Serotype 1||0.805|0.399|
71110941|NCT02628444|141727645|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|0.746|||||TWO_SIDED|98.75|0.55|1.01||||||Group 1a Booster/Group 1 Post-dose 3: Serotype 2||1.01|0.550|
71110942|NCT02628444|141727645|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|1.04|||||TWO_SIDED|98.75|0.686|1.57||||||Group 1a Booster/Group 1 Post-dose 3: Serotype 3||1.57|0.686|
71110943|NCT02628444|141727645|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|0.647|||||TWO_SIDED|98.75|0.434|0.963||||||Group 1a Booster/Group 1 Post-dose 3: Serotype 4||0.963|0.434|
70937426|NCT02841449|141374801|OTHER|||||||0.886|||||||t-test, 2 sided|paired sample||||||0.886
71063466|NCT03296527|141635554|SUPERIORITY||Mean ratio|1.08|||<|0.001|TWO_SIDED|95.0|1.04|1.12||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of FSH on stimulation Day 6||1.12|1.04|<0.001
71063467|NCT03296527|141635555|SUPERIORITY||Mean ratio|0.92|||<|0.001|TWO_SIDED|95.0|0.89|0.95||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of FSH at end-of-stimulation||0.95|0.89|<0.001
71063468|NCT03296527|141635556|SUPERIORITY||Mean ratio|1.03||||0.184|TWO_SIDED|95.0|0.99|1.07||The p-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of FSH at oocyte retrieval visit||1.07|0.99|0.184
71110944|NCT02628444|141727646|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided Bonferroni corrected 95% CI for the ratio of GMTs between groups (Group 2a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.627|||||TWO_SIDED|98.75|0.342|1.15||||||Group 2a Booster dose/Group 1 Post-dose 3: Serotype 1||1.15|0.342|
71110945|NCT02628444|141727646|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided Bonferroni corrected 95% CI for the ratio of GMTs between groups (Group 2a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.809|||||TWO_SIDED|98.75|0.505|1.3||||||Group 2a Booster/Group 1 Post-dose 3: Serotype 2||1.30|0.505|
71063469|NCT03296527|141635557|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value is based on van Elteren test adjusted for AMH group.||Total gonadotropin dose||||<.001
71063470|NCT03296527|141635559|SUPERIORITY|Treatment groups were compared using the van Elteren test.||||||0.001|||||||van Elteren|p-value is based on van Elteren test adjusted for AMH group.||Number of stimulation days||||0.001
71063471|NCT00122382|141635587|SUPERIORITY_OR_OTHER||Estimated Difference between ABA and PLA|15.1|||<|0.001|TWO_SIDED|95.0|6.0|24.2||p-value of \<0.05: probability for testing the difference between ABA and PLA.|Chi-squared, Continuity-Corrected|||Estimated Difference between ABA and PLA is the estimated difference between ABA and PLA in the proportion of subjects achieving an ACR 50 response.||24.2|6.0|<0.001
70937427|NCT02841449|141374801|OTHER|||||||0.43||||||The above is the trial\*time interaction. trial, p = 0.627; time, p \< 0.001|ANOVA|repeated measures||||||0.430
70937428|NCT02841449|141374802|OTHER|||||||0.369|||||||t-test, 2 sided|paired samples||||||0.369
71110946|NCT02628444|141727646|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided Bonferroni corrected 95% CI for the ratio of GMTs between groups (Group 2a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|1.19|||||TWO_SIDED|98.75|0.732|1.94||||||Group 2a Booster/Group 1 Post-dose 3: Serotype 3||1.94|0.732|
70937429|NCT02841449|141374802|OTHER|||||||0.859||||||The above is the trial\*time interaction. trial p = 0.200; time p \< 0.001|ANOVA|repeated measures||||||0.859
71110947|NCT02628444|141727646|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided Bonferroni corrected 95% CI for the ratio of GMTs between groups (Group 2a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.499|||||TWO_SIDED|98.75|0.331|0.754||||||Group 2a Booster/Group 1 Post-dose 3: Serotype 4||0.754|0.331|
71110948|NCT02628444|141727647|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1b booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|0.688|||||TWO_SIDED|98.75|0.479|0.989||||||Group 1b Booster/Group 1 Post-dose 3: Serotype 1||0.989|0.479|
71110949|NCT02628444|141727647|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1b booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|0.871|||||TWO_SIDED|98.75|0.673|1.13||||||Group 1b Booster/Group 1 Post-dose 3: Serotype 2||1.13|0.673|
71110950|NCT02628444|141727647|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1b booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|1.15|||||TWO_SIDED|98.75|0.887|1.49||||||Group 1b Booster/Group 1 Post-dose 3: Serotype 3||1.49|0.887|
71110951|NCT02628444|141727647|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1b booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|0.655|||||TWO_SIDED|98.75|0.471|0.911||||||Group 1b Booster/Group 1 Post-dose 3: Serotype 4||0.911|0.471|
71110952|NCT02628444|141727648|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2b Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.889|||||TWO_SIDED|98.75|0.462|1.71||||||Group 2b Booster/Group 1 Post-dose 3: Serotype 1||1.71|0.462|
71110953|NCT02628444|141727648|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2b Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.677|||||TWO_SIDED|98.75|0.402|1.14||||||Group 2b Booster/Group 1 Post-dose 3: Serotype 2||1.14|0.402|
71110954|NCT02628444|141727648|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2b Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.911|||||TWO_SIDED|98.75|0.573|1.45||||||Group 2b Booster/Group 1 Post-dose 3: Serotype 3||1.45|0.573|
70937430|NCT02841449|141374803|OTHER||||||<|0.001|||||||t-test, 2 sided|paired samples||||||<0.001
70937431|NCT02841449|141374803|OTHER|||||||0.261||||||The above is the trial\*time interaction. trial p = 0.002; time p = 0.282|ANOVA|repeated measures||||||0.261
70937432|NCT02841449|141374804|OTHER|||||||0.736|||||||t-test, 2 sided|paired samples||||||0.736
71110955|NCT02628444|141727648|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2b Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.702|||||TWO_SIDED|98.75|0.447|1.1||||||Group 2b Booster/Group 1 Post-dose 3: Serotype 4||1.10|0.447|
71110956|NCT02628444|141727649|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|1.05|||||TWO_SIDED|95.0|0.833|1.33||||||Group2/Group1: Serotype 1 (28 days after last vaccination)||1.33|0.833|
70937433|NCT02841449|141374805|OTHER|||||||0.542|||||||t-test, 2 sided|paired samples||||||0.542
70937434|NCT02841449|141374806|OTHER|||||||0.4|||||||t-test, 2 sided|paired samples||||||0.400
70937435|NCT02841449|141374807|OTHER|||||||0.646|||||||ANOVA|repeated measures||Visual analogue scale for thirst||||0.646
70937436|NCT02841449|141374807|OTHER|||||||0.403|||||||ANOVA|repeated measures||visual analogue scale for desire for savoury||||0.403
70937437|NCT02841449|141374807|OTHER|||||||0.022|||||||ANOVA|repeated measures||visual analogue scale for desire for salt||||0.022
70937438|NCT02841449|141374807|OTHER|||||||0.849|||||||ANOVA|repeated measures||visual analogue scale for hunger||||0.849
70937439|NCT02841449|141374807|OTHER|||||||0.062|||||||ANOVA|repeated measures||visual analogue scale for fullness||||0.062
70937440|NCT02841449|141374807|OTHER|||||||0.549|||||||ANOVA|repeated measures||visual analogue scale for how much participants felt they could eat||||0.549
70937441|NCT02841449|141374807|OTHER|||||||0.402|||||||ANOVA|repeated measures||visual analogue scale for sweet desire||||0.402
70937442|NCT02841449|141374807|OTHER|||||||0.138|||||||ANOVA|repeated measures||visual analogue scale for fatty food desire||||0.138
70937443|NCT02841449|141374808|OTHER|||||||0.055||||||Above is trial\*time effect. trial p = 0.135; time p = 0.011|ANOVA|repeated measures||||||0.055
70937444|NCT02841449|141374809|OTHER|||||||0.226|||||||t-test, 2 sided|paired sample||||||0.226
70937445|NCT02841449|141374810|OTHER||||||<|0.001|||||||t-test, 2 sided|paired samples||||||< 0.001
71063472|NCT00122382|141635588|SUPERIORITY_OR_OTHER||Estimated Difference between ABA and PLA|15.5|||<|0.001|TWO_SIDED|95.0|8.2|22.8||p-value of \<0.05: probability for testing the difference between ABA and PLA.|Chi-squared, Continuity-Corrected|||Estimated Difference between ABA and PLA is the estimated difference between ABA and PLA in the proportion of subjects achieving MCR.||22.8|8.2|<0.001
71063473|NCT00122382|141635589|SUPERIORITY_OR_OTHER||Estimate of/Adjusted Difference|-0.73|||<|0.001|TWO_SIDED|95.0|-0.98|-0.48||p-value of \<0.05: probability for testing the difference between ABA and PLA.|ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.||||-0.48|-0.98|<0.001
71063474|NCT00122382|141635590|SUPERIORITY_OR_OTHER||Estimated Difference between ABA and PLA|9.8||||0.024|TWO_SIDED|95.0|1.3|18.4||p-value of \<0.05: probability for testing the difference between ABA and PLA.|Chi-squared, Continuity-Corrected|||Estimated Difference between ABA and PLA is the estimated difference between ABA and PLA in the proportion of subjects achieving HAQ response.||18.4|1.3|0.024
71063475|NCT00122382|141635591|SUPERIORITY_OR_OTHER||Estimate of/Adjusted Difference|2.5||||0.005|TWO_SIDED|95.0|0.77|4.23||p-value of \<0.05: probability for testing the difference between ABA and PLA.|ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.||PCS Adjusted Mean Change from Baseline to Month 12||4.23|0.77|0.005
71063476|NCT00122382|141635591|SUPERIORITY_OR_OTHER||Estimate of/Adjusted Difference|1.81||||0.046|TWO_SIDED|95.0|0.03|3.6||p-value of \<0.05: probability for testing the difference between ABA and PLA.|ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.||MCS Adjusted Mean Change from Baseline to Month 12||3.60|0.03|0.046
71063477|NCT00122382|141635592|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||P-value of \<0.05: probability for comparison of change in radiographic scores between abatacept and placebo.|Nonparametric ANCOVA|||comparison of change in erosion scores between abatacept and placebo||||0.033
71110957|NCT02628444|141727649|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|0.99|||||TWO_SIDED|95.0|0.821|1.19||||||Group2/Group1: Serotype 2 (28 days after last vaccination)||1.19|0.821|
71110958|NCT02628444|141727649|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|0.972|||||TWO_SIDED|95.0|0.81|1.17||||||Group2/Group1: Serotype 3 (28 days after last vaccination)||1.17|0.810|
71110959|NCT02628444|141727649|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|0.963|||||TWO_SIDED|95.0|0.814|1.14||||||Group2/Group1: Serotype 4 (28 days after last vaccination)||1.14|0.814|
70937446|NCT00346398|141374842|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3||||0.28|TWO_SIDED|95.0|0.5|10.5||Odds Ratios are calculated using a logistic regression with a Wald chi square test. Experimental group participants had a higher proportion of allergic sensitization than participants who received placebo|Chi-squared|||Participants who drop out (have missing efficacy endpoints) are considered treatment failures.||10.5|0.5|0.28
71063478|NCT00122382|141635592|SUPERIORITY_OR_OTHER|||||||0.353||95.0||||P-value of \<0.05: probability for comparison of change in radiographic scores between abatacept and placebo.|Nonparametric ANCOVA|||comparison of change in JSN scores between abatacept and placebo||||0.353
71063479|NCT00122382|141635594|SUPERIORITY_OR_OTHER||Estimated Difference between ABA and PLA|18.1|||<|0.001|TWO_SIDED|95.0|9.6|26.6||Total score was tested only if there was statistical significance in remission rate. For each test, the nominal type I error rate is set at 5%; this sequential testing procedure preserves the overall type I error rate at 5%.|Chi-squared, Continuity-Corrected|||Estimated Difference between ABA and PLA is the estimated difference between ABA and PLA in the proportion of subjects achieving DAS28-CRP remission.||26.6|9.6|<0.001
71063480|NCT00122382|141635595|SUPERIORITY_OR_OTHER||||||<|0.04||95.0||||Total score was tested only if there was statistical significance in remission rate. For each test, the nominal type I error rate is set at 5%; this sequential testing procedure preserves the overall type I error rate at 5%.|non-parametric ANCOVA|||||||<0.040
71063481|NCT00122382|141635610|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||signed rank test|||||||<0.001
71063482|NCT02040805|141635613|NON_INFERIORITY|Margin based on clinically meaningful change of \>= 5 points.||||||0.04|||||||t-test, 1 sided|||Test of non-inferiority.||||0.04
71063483|NCT02040805|141635614|NON_INFERIORITY|Margin based on clinically meaningful change of \>= 2.5 points.||||||0.05|||||||t-test, 1 sided|||Test of non-inferiority.||||0.05
71063484|NCT02040805|141635615|OTHER|linear mixed models analysis|||||<|0.0001|||||||Mixed Models Analysis|df=1||||||<0.0001
71063485|NCT02040805|141635616|OTHER|linear mixed model|||||<|0.0001|||||||Mixed Models Analysis|df=1||||||<0.0001
71063486|NCT01008605|141635617|SUPERIORITY_OR_OTHER||Lower limit, 95% one-sided CI|95.83|||||ONE_SIDED|95.0|87.46||||||||||87.46|
71063487|NCT01213966|141635624|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||PPR24 was summarized descriptively. No statistical test was performed. The PRR24 values were summarised when the corresponding regression fit had a p-value of p ≤0.01 and an adjusted coefficient of determination (R2) ≥0.85.|Regression, Linear|||PPR24 was summarised descriptively. No statistical test was performed.||||0.01
71110960|NCT02628444|141727649|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|1.03|||||TWO_SIDED|95.0|0.762|1.39||||||Group2/Group1: Serotype 1 (1 year after last vaccination)||1.39|0.762|
71110961|NCT02628444|141727649|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|0.917|||||TWO_SIDED|95.0|0.724|1.16||||||Group2/Group1: Serotype 2 (1 year after last vaccination)||1.16|0.724|
70937447|NCT00346398|141374843|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.85|TWO_SIDED|95.0|0.2|6.1||Odds Ratios are calculated using unadjusted exact logistic regression with mid p-value to adjust for the discreteness of the distribution|Chi-squared|||Participants who drop out (have missing efficacy endpoints) are considered treatment failures.||6.1|0.2|0.85
70937448|NCT00346398|141374844|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.8||||0.28|TWO_SIDED|95.0|0.6|5.6||P-value is calculated using a log-rank test|Regression, Logistic||Hazard ratio and 95% confidence intervals are calculated using an unadjusted Cox regression|||5.6|0.6|0.28
70937449|NCT03979040|141374845|NON_INFERIORITY|A non-inferiority margin of -.5 was set for outcome analysis with a one-sided alpha of .025.|Mean Difference (Net)|-0.5||||0.025|ONE_SIDED|97.5||||P value = .025 (one-sided) and sign test below|Sign test|||||||.025
70937450|NCT03979040|141374846|NON_INFERIORITY|A non-inferiority margin of -.5 was set for outcome analysis with a one-sided alpha of .025.|Mean Difference (Net)|-0.5||||0.025|ONE_SIDED|97.5|||||Sign test|||||||.025
70937451|NCT03979040|141374847|NON_INFERIORITY|A non-inferiority margin of -.5 was set for outcome analysis with a one-sided alpha of .025.|Mean Difference (Net)|-0.5||||0.025|ONE_SIDED|97.5|||||Sign test|||||||.025
71063488|NCT01205776|141635652|NON_INFERIORITY|p-value and 95% CI of the Difference derived from the Com-Nougue Approach of non-inferiority for two Kaplan-Meier Failure rates with a non-inferiority margin of 2% at the 0.05 level of significance.|Hazard Ratio (HR)|-3.1|||<|0.0001|TWO_SIDED|||||p-value and 95% CI of the Difference derived from the Com-Nougue Approach of non-inferiority for two Kaplan-Meier Failure rates with a non-inferiority margin of 2% at the 0.05 level of significance.|Com-Nougue|||||||<0.0001
71063489|NCT01205776|141635664|NON_INFERIORITY|p-value and 95% CI of the Difference derived from the Com-Nougue Approach of non-inferiority for two Kaplan-Meier Failure rates with a non-inferiority margin of 8.4% at the 0.05 level of significance.|Hazard Ratio (HR)|4.0||||0.011|TWO_SIDED|||||p-value and 95% CI of the Difference derived from the Com-Nougue Approach of non-inferiority for two Kaplan-Meier Failure rates with a non-inferiority margin of 8.4% at the 0.05 level of significance.|Com-Nougue Approach|||||||0.011
71063490|NCT01622673|141635747|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for TUMS® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.678|||||TWO_SIDED|90.0|0.531|0.866|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and treatment period and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean C12hrs for TUMS® + raltegravir / geometric least squares mean C12hrs for raltegravir alone|||0.866|0.531|
71063491|NCT01622673|141635747|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% CI falls above 0.4 for the geometric least squares mean ratio for MINTOX® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.373|||||TWO_SIDED|90.0|0.293|0.475|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and treatment period and random effect for participant|The parameter estimated, geometric least squares mean ratio, is the geometric least squares mean C12hrs for MINTOX® + raltegravir / geometric least squares mean C12hrs for raltegravir alone|||0.475|0.293|
71063492|NCT01622673|141635748|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® before raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.437|||||TWO_SIDED|90.0|0.344|0.554|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean C12hrs for MINTOX® before raltegravir / geometric least squares mean C12hrs for raltegravir alone|||0.554|0.344|
71063493|NCT01622673|141635748|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® after raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.433|||||TWO_SIDED|90.0|0.341|0.55|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean C12hrs for MINTOX® after raltegravir / geometric least squares mean C12hrs for raltegravir alone|||0.550|0.341|
71063494|NCT01622673|141635749|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for TUMS® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.445|||||TWO_SIDED|90.0|0.35|0.565|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and treatment period and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean AUC0-12hrs for TUMS® + raltegravir / geometric least squares mean AUC0-12hrs for raltegravir alone|||0.565|0.350|
71063495|NCT01622673|141635749|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.51|||||TWO_SIDED|90.0|0.402|0.646|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and treatment period and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean AUC0-12hrs for MINTOX® + raltegravir / geometric least squares mean AUC0-12hrs for raltegravir alone|||0.646|0.402|
71063496|NCT01622673|141635750|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® before raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.485|||||TWO_SIDED|90.0|0.351|0.669|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean AUC0-12hrs for MINTOX® before raltegravir / geometric least squares mean AUC0-12hrs for raltegravir alone|||0.669|0.351|
71078152|NCT03300050|141664644|OTHER||GMT Ratio|0.82||||0.6754|TWO_SIDED|95.0|0.47|1.45|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Adjusted GMT Ratio 28 Days Post-Boost Dose||1.45|0.47|0.6754
71110962|NCT02628444|141727649|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|0.933|||||TWO_SIDED|95.0|0.742|1.17||||||Group2/Group1: Serotype 3 (1 year after last vaccination)||1.17|0.742|
71110963|NCT02628444|141727649|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|0.916|||||TWO_SIDED|95.0|0.75|1.12||||||Group2/Group1: Serotype 4 (1 year after last vaccination)||1.12|0.750|
71110964|NCT02079909|141727686|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.3919|TWO_SIDED||||||Mixed Models Analysis|||||||0.3919
71110965|NCT02079909|141727687|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.7588|TWO_SIDED||||||Mixed Models Analysis|||||||0.7588
71110966|NCT02079909|141727688|SUPERIORITY||Mean Difference (Final Values)|1.29||||0.3212|TWO_SIDED||||||Mixed Models Analysis|||||||0.3212
71110967|NCT02277249|141727689|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||No power calculation performed given that this was a pilot study. The null hypothesis was that there would be no difference in pain score with injection between the two study arms. The Wilcoxon rank sum test was selected because of the study's small sample size and the non-normal distribution of pain scores. Intention to treat analyses were used.||||0.36
71110968|NCT01869634|141727707|OTHER|Wilcoxon signed-rank test. Paired samples.||||||0.0025|||||||Sign test|||Comparison between HIV positive naïve to ART before and after ART has been done.||||0.0025
71110969|NCT01869634|141727708|OTHER|Two-sample Wilcoxon rank-sum (Mann-Whitney) test||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
70937452|NCT02607956|141374848|NON_INFERIORITY|A sample of approximately 600 participants randomized 1:1 achieves at least 95% power using a non-inferiority margin of 12% assuming a response rate in both groups of 91% (Reference Genvoya studies) and a one-sided alpha level of 0.025.|Difference in Percentages|-3.5|||||TWO_SIDED|95.002|-7.9|1.0|||||Differences in percentages of participants between groups and their 95.002% CIs were calculated based on Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||1.0|-7.9|
71110970|NCT01869634|141727708|OTHER|Wilcoxon signed-rank test||||||0.826|||||||Sign test|||Comparison of coronary artery wall thickness before and after ART in the HIV infected participants.||||0.826
71110971|NCT01869634|141727709|OTHER|Two-sample Wilcoxon rank-sum (Mann-Whitney) test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||comparison between groups (HIV+ vs HIV-)||||<0.001
71110972|NCT01869634|141727709|OTHER|||||||0.807|||||||Sign test|||Changes in systemic immune activation through IL6||||0.807
71110973|NCT04551898|141727729|SUPERIORITY||Least square Mean|-0.25||||0.4829|TWO_SIDED|90.0|-0.84|0.34|||Mixed Models Analysis|||||0.34|-0.84|0.4829
71110974|NCT04551898|141727729|SUPERIORITY||Least square Mean|-0.51||||0.1739|TWO_SIDED|90.0|-1.13|0.11|||Mixed Models Analysis|||||0.11|-1.13|0.1739
71110975|NCT04551898|141727729|SUPERIORITY||Least square Mean|0.19||||0.6006|TWO_SIDED|90.0|-0.4|0.77|||Mixed Models Analysis|||||0.77|-0.40|0.6006
71110976|NCT04551898|141727729|SUPERIORITY|||||||0.4996||||||H0: there is a flat dose response curve comparing change from baseline to Day 8 in viral load in the Placebo and other BGB-DXP593 dose groups|t-test, 1 sided|MCP Mod was used to test the primary hypothesis and provide 1-sided p-value accordingly.||||||0.4996
71110977|NCT00559104|141727828|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.51||||0.51|TWO_SIDED|95.0|0.07|3.79|||Regression, Cox||"Parameter Dispersion Type: Standard Error of the Parameter Estimate, not of the mean.~Standard Error = 1.02475"|There is no power calculation as this is a phase II study. This is an Event-free Survival, in which an event can be Relapse/Progression, or Death. Censoring can be at the End of follow-up date, or at the End of study date.||3.79|0.07|0.51
71110978|NCT00559104|141727829|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.66||||0.69|TWO_SIDED|95.0|0.09|4.99|||Regression, Cox||"Numerator: Carmustine in the conditioning. Denominator: Irradiation in the conditioning.~Parameter: Hazard ratio. Dispersion: Standard Error of the Hazard Ratio."|Phase II analysis: There was no power calculation.||4.99|0.09|0.69
71110979|NCT00620373|141727839|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||t-test, 2 sided|||Significant difference p ≤ 0.05||||.016
71110980|NCT00620373|141727839|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||McNemar|||significant difference p ≤ 0.05||||.07
71110981|NCT00620373|141727840|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||McNemar|||For all cancers; significant difference p ≤ 0.05||||.016
71110982|NCT00620373|141727840|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||McNemar|||For all cancers; significant difference p ≤ 0.05||||.07
71110983|NCT00620373|141727840|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||McNemar|||For invasive cancers; significant difference p ≤ 0.05||||.063
71110984|NCT00620373|141727840|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||McNemar|||For invasive cancers; significant difference p ≤ 0.05||||.063
71110985|NCT00620373|141727840|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||McNemar|||For ductal carcinoma in situ; significant difference p ≤ 0.05||||.5
71110986|NCT00620373|141727840|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||McNemar|||For ductal carcinoma in situ; significant difference p ≤ 0.05||||>.99
71110987|NCT00620373|141727842|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||McNemar|||significant difference p ≤ 0.05||||<.001
71110988|NCT00620373|141727842|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||McNemar|||significant difference p ≤ 0.05||||.069
71110989|NCT00620373|141727843|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||McNemar|||significant difference p ≤ 0.05||||<.001
71110990|NCT00620373|141727843|SUPERIORITY_OR_OTHER|||||||0.218||95.0|||||McNemar|||significant difference p ≤ 0.05||||.218
71110991|NCT01891396|141727942|SUPERIORITY|||||||0.0099|||||||ANOVA|||||||0.0099
71110992|NCT01891396|141727943|SUPERIORITY|||||||0.0367|||||||ANOVA|||||||0.0367
71110993|NCT01891396|141727944|SUPERIORITY|||||||0.0289|||||||ANOVA|||||||0.0289
71110994|NCT01891396|141727945|SUPERIORITY|||||||0.0141|||||||ANOVA|||||||0.0141
71110995|NCT01891396|141727946|SUPERIORITY|||||||0.0002|||||||ANOVA|||||||0.0002
71110996|NCT01891396|141727947|SUPERIORITY|||||||0.0533|||||||ANOVA|||||||0.0533
71110997|NCT01891396|141727948|SUPERIORITY|||||||0.0323|||||||ANOVA|||||||0.0323
70937453|NCT02607956|141374848|SUPERIORITY|||||||0.12|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.12
70937454|NCT02607956|141374849|OTHER||Difference in Percentages|-2.3|||||TWO_SIDED|95.0|-7.9|3.2|||||Differences in percentages of participants between groups and their 95% CIs were calculated based on MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||3.2|-7.9|
71063497|NCT01622673|141635750|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® after raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.696|||||TWO_SIDED|90.0|0.504|0.96|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean AUC0-12hrs for MINTOX® after raltegravir / geometric least squares mean AUC0-12hrs for raltegravir alone|||0.960|0.504|
71063498|NCT01622673|141635751|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for TUMS® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.476|||||TWO_SIDED|90.0|0.362|0.627|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and treatment period and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean Cmax for TUMS® + raltegravir / geometric least squares mean Cmax for raltegravir alone|||0.627|0.362|
71063499|NCT01622673|141635751|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% CI falls above 0.4 for the geometric least squares mean ratio for MINTOX® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.555|||||TWO_SIDED|95.0|0.423|0.729|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and treatment period and random effect for participant|The parameter estimated, geometric least squares mean ratio, is the geometric least squares mean Cmax for MINTOX® + raltegravir / geometric least squares mean Cmax for raltegravir alone|||0.729|0.423|
71063500|NCT01622673|141635752|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® before raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.485|||||TWO_SIDED|90.0|0.332|0.709|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean Cmax for MINTOX® before raltegravir / geometric least squares mean Cmax for raltegravir alone|||0.709|0.332|
71063501|NCT01622673|141635752|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® after raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.775|||||TWO_SIDED|90.0|0.53|1.132|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean Cmax for MINTOX® after raltegravir / geometric least squares mean Cmax for raltegravir alone|||1.132|0.530|
71063502|NCT05514873|141635762|NON_INFERIORITY|Non-inferiority of Week 12 MG-ADL over Baseline was shown if the upper limit of the 2-sided 95% confidence interval (CI) is less than 2.|||||<|0.001|||||||Mixed Model for Repeated Measures (MMRM)|||||||<0.001
71110998|NCT01891396|141727949|SUPERIORITY|||||||0.0072|||||||ANOVA|||||||0.0072
71063503|NCT07091916|141635783|OTHER|This objective was for the purpose of gathering data pertaining to device safety over the first 2 weeks post-implant. There were no pre-specified performance criteria or hypotheses for this objective.|Proportion|92.9|||||TWO_SIDED||||||descriptive statistics|||The first primary objective is to characterize the freedom from major complications related to the EV ICD System and/or procedure at 2 weeks post-implant. The endpoint is defined as a subject's first occurrence of a major complication related to the EV ICD System and/or procedure, as determined by an independent Clinical Events Committee (CEC), that occurs on or prior to 2 weeks (14 days) post-implant.||||
71063504|NCT07091916|141635784|OTHER|There were no hypotheses for this objective.|Proportion|100.0|||||||||||descriptive statistics|||The primary efficacy objective was to characterize the defibrillation efficacy at implant of the EV ICD System.||||
71063505|NCT00437021|141635794|NON_INFERIORITY|The non-inferiority margin is 1. Non-inferiority of Group A is concluded if the upper limit of the 95% confidence interval for the mean difference in the log2 transformed peak titers between groups is less than 1.|Mean Difference (Final Values)|1.48|||||TWO_SIDED|95.0|0.97|1.99|||||Estimate and corresponding 95% confidence interval are calculated on the log2 scale.|Null hypothesis: The mean difference in log2 transformed titers between Group B and Group A \>= 1.||1.99|0.97|
71063506|NCT00437021|141635795|NON_INFERIORITY|The non-inferiority margin is 1. Non-inferiority of Group A is concluded if the upper limit of the 95% confidence interval for the mean difference in the log2 transformed peak titers between groups is less than 1.|Mean Difference (Final Values)|2.895|||||TWO_SIDED|95.0|2.22|3.69|||||Estimate and corresponding 95% confidence interval are calculated on the log2 scale.|Null hypothesis: The mean difference in log2 transformed titers between Group B and Group A \>= 1.||3.69|2.22|
71110999|NCT01891396|141727950|SUPERIORITY|||||||0.003|||||||ANOVA|||||||0.0030
71111000|NCT01891396|141727951|SUPERIORITY|||||||0.044|||||||ANOVA|||||||0.0440
71111001|NCT01891396|141727952|SUPERIORITY|||||||0.0579|||||||ANOVA|||||||0.0579
71111002|NCT01891396|141727953|SUPERIORITY|||||||0.0005|||||||ANOVA|||||||0.0005
71111003|NCT01891396|141727954|SUPERIORITY|||||||0.0046|||||||ANOVA|||||||0.0046
71111004|NCT01891396|141727955|SUPERIORITY|||||||0.0029|||||||ANOVA|||||||0.0029
71111005|NCT01891396|141727956|SUPERIORITY|||||||0.0087|||||||ANOVA|||||||0.0087
71111006|NCT01891396|141727957|SUPERIORITY|||||||0.0154|||||||ANOVA|||||||0.0154
71111007|NCT01891396|141727958|SUPERIORITY|||||||0.0227|||||||ANOVA|||||||0.0227
71111008|NCT01891396|141727959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|TWO_SIDED||||||ANOVA|||||||0.0002
71111009|NCT01891396|141727960|SUPERIORITY|||||||0.0148|||||||ANOVA|||||||0.0148
71111010|NCT01891396|141727961|SUPERIORITY|||||||0.0113|||||||ANOVA|||||||0.0113
71063507|NCT00437021|141635803|NON_INFERIORITY|The non-inferiority margin is 1. Non-inferiority of Group A is concluded if the upper limit of the 95% confidence interval for the mean difference in the log2 transformed peak titers between groups is less than 1.|Mean Difference (Final Values)|2.21|||||TWO_SIDED|95.0|1.65|2.76|||||Estimate and corresponding 95% confidence interval are calculated on the log2 scale.|Null hypothesis: The mean difference in log2 transformed titers between Group B and Group A \>= 1.||2.76|1.65|
71063508|NCT00437021|141635804|NON_INFERIORITY|The non-inferiority margin is 1. Non-inferiority of Group A is concluded if the upper limit of the 95% confidence interval for the mean difference in the log2 transformed peak titers between groups is less than 1.|Mean Difference (Final Values)|3.08|||||TWO_SIDED|95.0|2.57|3.59|||||Estimate and corresponding 95% confidence interval are calculated on the log2 scale.|Null hypothesis: The mean difference in log2 transformed titers between Group B and Group A \>= 1.||3.59|2.57|
71063509|NCT03158038|141635853|SUPERIORITY||Rate difference|0.0|||||TWO_SIDED|95.0|-6.7|1.9||||||||1.9|-6.7|
71063510|NCT03158038|141635854|SUPERIORITY||Rate difference|1.3|||||TWO_SIDED|95.0|-12.8|13.2||||||Statistical analysis up to Day 8||13.2|-12.8|
71063511|NCT03158038|141635854|SUPERIORITY||Rate difference|0.4|||||TWO_SIDED|95.0|-14.1|13.2||||||Statistical analysis up to Day 15||13.2|-14.1|
71063512|NCT02612623|141635907|OTHER||LSM Difference|-0.56|||||TWO_SIDED|95.0|-2.08|0.96|||||Gefapixant minus Placebo|Least squares mean (LSM) difference: Mixed effect repeated measures model (MMRM) uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.||0.96|-2.08|
71063513|NCT02612623|141635907|OTHER||LSM Difference|-0.71|||||TWO_SIDED|95.0|-2.34|0.92|||||Gefapixant minus Placebo|LSM difference: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.||0.92|-2.34|
71063514|NCT02612623|141635907|OTHER||LSM Difference|-1.35|||||TWO_SIDED|95.0|-2.99|0.3|||||Gefapixant minus Placebo|LSM difference: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.||0.30|-2.99|
71063515|NCT02612623|141635907|OTHER||Percentage Change|-42.6|||||TWO_SIDED|95.0|-87.5|162.3|||||100 x \[(Exponent of LSM Difference) minus 1\]|Estimated Percentage Change: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.||162.3|-87.5|
71063516|NCT02612623|141635907|OTHER||Percentage Change|-50.8|||||TWO_SIDED|95.0|-90.3|151.1|||||100 x \[(Exponent of LSM Difference) minus 1\]|Estimated Percentage Change: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.||151.1|-90.3|
71063517|NCT02612623|141635907|OTHER||Percentage Change|-74.0|||||TWO_SIDED|95.0|-95.0|34.7|||||100 x \[(Exponent of LSM Difference) minus 1\]|Estimated Percentage Change: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.||34.7|-95.0|
71063518|NCT03971071|141635948|SUPERIORITY||Common odds ratio|1.37||||0.13|TWO_SIDED|95.0|0.92|2.05|||Cochran-Mantel-Haenszel||Erenumab 70 mg versus Placebo. Common odds ratio and p-value were obtained from a Cochran-Mantel-Haenszel test, stratified by concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No).|||2.05|0.92|0.13
71063519|NCT03971071|141635948|SUPERIORITY||Common odds ratio|2.01|||<|0.001|TWO_SIDED|95.0|1.33|3.05|||Cochran-Mantel-Haenszel||Erenumab 140 mg versus Placebo. Common odds ratio and p-value were obtained from a Cochran-Mantel-Haenszel test, stratified by concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No).|||3.05|1.33|<0.001
71063520|NCT03971071|141635949|SUPERIORITY||Least squares mean difference|-1.23||||0.033|TWO_SIDED|95.0|-2.35|-0.1||Nominal p-value is presented without multiplicity adjustment.|Linear Mixed Model||Erenumab 70 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.|||-0.10|-2.35|0.033
71063521|NCT03971071|141635949|SUPERIORITY||Least squares mean difference|-2.74|||<|0.001|TWO_SIDED|95.0|-3.87|-1.62||Nominal p-value is presented without multiplicity adjustment.|Linear Mixed Model||Erenumab 140 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.|||-1.62|-3.87|<0.001
71063522|NCT03971071|141635950|SUPERIORITY||Common odds ratio|1.62||||0.019|TWO_SIDED|95.0|1.08|2.43|||Cochran-Mantel-Haenszel||Erenumab 70 mg versus Placebo. Common odds ratio and p-value were obtained from a Cochran-Mantel-Haenszel test, stratified by concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No).|||2.43|1.08|0.019
71063523|NCT03971071|141635950|SUPERIORITY||Common odds ratio|2.63|||<|0.001|TWO_SIDED|95.0|1.75|3.96|||Cochran-Mantel-Haenszel||Erenumab 140 mg versus Placebo. Common odds ratio and p-value were obtained from a Cochran-Mantel-Haenszel test, stratified by concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No).|||3.96|1.75|<0.001
71063524|NCT03971071|141635951|SUPERIORITY||Least squares mean difference|-3.25||||0.007|TWO_SIDED|95.0|-5.62|-0.88||Nominal p-value is presented without multiplicity adjustment.|Linear Mixed Model||Erenumab 70 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.|||-0.88|-5.62|0.007
71063525|NCT03971071|141635951|SUPERIORITY||Least squares mean difference|-2.13||||0.075|TWO_SIDED|95.0|-4.48|0.22||Nominal p-value is presented without multiplicity adjustment.|Linear Mixed Model||Erenumab 140 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.|||0.22|-4.48|0.075
71063526|NCT03971071|141635952|SUPERIORITY||Least squares mean difference|-2.61||||0.028|TWO_SIDED|95.0|-4.92|-0.29||Nominal p-value is presented without multiplicity adjustment.|Linear Mixed Model||Erenumab 70 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.|||-0.29|-4.92|0.028
71111011|NCT01891396|141727962|SUPERIORITY|||||||0.0016|||||||ANOVA|||||||0.0016
70937455|NCT02607956|141374849|OTHER|||||||0.41|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.41
70937456|NCT02607956|141374850|OTHER||Difference in Percentages|-1.9|||||TWO_SIDED|95.0|-7.8|3.9|||||Differences in percentages of participants between groups and their 95% CIs were calculated based on MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||3.9|-7.8|
70937457|NCT02607956|141374850|OTHER|||||||0.52|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.52
70937458|NCT02607956|141374851|OTHER||Difference in Percentages|-3.9|||||TWO_SIDED|95.0|-9.4|1.5|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||1.5|-9.4|
70937459|NCT02607956|141374851|OTHER|||||||0.16|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.16
71063527|NCT03971071|141635952|SUPERIORITY||Least squares mean difference|-2.37||||0.043|TWO_SIDED|95.0|-4.67|-0.07||Nominal p-value is presented without multiplicity adjustment.|Linear Mixed Model||Erenumab 140 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.|||-0.07|-4.67|0.043
71063528|NCT02816736|141635974|SUPERIORITY||ratio of the AUCs|0.95||||0.45|TWO_SIDED|95.0|0.84|1.08|||Regression, Linear|||AUC was normalized for time; With the log-scale, the value of 0 indicates, on average, no change in NTproBNP from baseline.||1.08|0.84|0.45
71063529|NCT02816736|141635975|SUPERIORITY||Mean Difference (Net)|-11.22||||0.15|TWO_SIDED|95.0|-26.4|3.97|||general linear model|||||3.97|-26.4|0.15
71063530|NCT02816736|141635976|SUPERIORITY||Odds Ratio (OR)|1.14||||0.51|TWO_SIDED|95.0|0.78|1.68|||ordinal logistic regression|||||1.68|0.78|0.51
71063531|NCT02816736|141635977|SUPERIORITY||Odds Ratio (OR)|1.55||||0.16|TWO_SIDED|95.0|0.84|2.87|||Regression, Logistic|||||2.87|0.84|0.16
71063532|NCT02816736|141635978|SUPERIORITY||Odds Ratio (OR)|0.99||||0.99|TWO_SIDED|95.0|0.34|2.91|||Regression, Logistic|||||2.91|0.34|0.99
71063533|NCT02816736|141635979|SUPERIORITY||Odds Ratio (OR)|2.05||||0.035|TWO_SIDED|95.0|1.05|4.0|||Regression, Logistic|||||4.00|1.05|0.035
71063534|NCT01139775|141635990|SUPERIORITY_OR_OTHER||Bayesian Posterior Probability|0.96|||||TWO_SIDED||||||||Pemetrexed + cisplatin + LY2603618 was considered superior to pemetrexed + cisplatin if the posterior probability of superiority exceeded 0.85.|The analysis for comparing progression-free survival time between the treatment arms used a Bayesian Augmented Control model with a hierarchical random-effects distribution on treatment effects. The final model incorporated historical data from a completed Phase 3 study (NCT00789373) to augment the prospective control arm data.||||
70937460|NCT02607956|141374852|OTHER||Difference in Percentages|-2.5|||||TWO_SIDED|95.0|-8.8|3.8|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||3.8|-8.8|
71063535|NCT01139775|141635992|SUPERIORITY_OR_OTHER|||||||0.2294|TWO_SIDED|||||The test of treatment effect was conducted at a 2-sided alpha level of 0.10.|Log Rank|||||||0.2294
71063536|NCT01139775|141635993|SUPERIORITY_OR_OTHER|||||||0.0824|TWO_SIDED|||||The test of treatment effect was conducted at a 2-sided alpha level of 0.10.|Chi-squared|||||||0.0824
71063537|NCT01139775|141635994|SUPERIORITY_OR_OTHER|||||||0.4924|TWO_SIDED|||||The test of treatment effect was conducted at a 2-sided alpha level of 0.10.|Wilcoxon (Mann-Whitney)|||||||0.4924
71063538|NCT01139775|141636005|SUPERIORITY_OR_OTHER|||||||0.0946|TWO_SIDED|||||The test of treatment effect was conducted at a 2-sided alpha level of 0.10.|Chi-squared|||||||0.0946
71063539|NCT00450437|141636034|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.89|||||TWO_SIDED|95.0|0.68|1.16|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain A at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.16|0.68|
71063540|NCT00450437|141636034|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.95|||||TWO_SIDED|95.0|0.73|1.23|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.23|0.73|
70937461|NCT02607956|141374852|OTHER|||||||0.44|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.44
71063541|NCT00450437|141636034|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.06|||||TWO_SIDED|95.0|0.81|1.38|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.38|0.81|
71111012|NCT01891396|141727963|SUPERIORITY|||||||0.0056|||||||ANOVA|||||||0.0056
71111013|NCT01891396|141727964|SUPERIORITY|||||||0.0095|||||||ANOVA|||||||0.0095
71111014|NCT01891396|141727965|SUPERIORITY|||||||0.0136|||||||ANOVA|||||||0.0136
71111015|NCT01891396|141727966|SUPERIORITY|||||||0.0005|||||||ANOVA|||||||0.0005
70937462|NCT02607956|141374853|OTHER||Difference in Percentages|-1.1|||||TWO_SIDED|95.0|-7.4|5.3|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||5.3|-7.4|
70937463|NCT02607956|141374853|OTHER|||||||0.74|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.74
70937464|NCT02607956|141374854|OTHER||Difference in LSM|0.08||||0.081|TWO_SIDED|95.0|-0.01|0.17|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in least-squares mean (LSM), and its 95% confidence interval (CI) were adjusted by baseline HIV-1 RNA stratum and region stratum.|||0.17|-0.01|0.081
70937465|NCT02607956|141374855|OTHER||Difference in LSM|0.06||||0.18|TWO_SIDED|95.0|-0.03|0.15|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.|||0.15|-0.03|0.18
70937466|NCT02607956|141374856|OTHER||Difference in LSM|0.09||||0.054|TWO_SIDED|95.0|0.0|0.18|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.|||0.18|0.00|0.054
70937467|NCT02607956|141374857|OTHER||Difference in LSM|-23.0||||0.096|TWO_SIDED|95.0|-49.0|4.0|||ANOVA|P-value was adjusted by the baseline HIV-1 RNA and region stratum.|Difference in LSM, and its 95% CI were adjusted by the baseline HIV-1 RNA and region stratum.|||4|-49|0.096
70937468|NCT02607956|141374858|OTHER||Difference in LSM|-47.0||||0.008|TWO_SIDED|95.0|-81.0|-12.0|||ANOVA|P-value was adjusted by the baseline HIV-1 RNA and region stratum.|Difference in LSM, and its 95% CI were adjusted by the baseline HIV-1 RNA and region stratum.|||-12|-81|0.008
70937469|NCT02607956|141374859|OTHER||Difference in LSM|-14.0||||0.48|TWO_SIDED|95.0|-52.0|25.0|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.|||25|-52|0.48
70937470|NCT00696241|141374902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.75|||<|0.001||95.0|-13.17|-8.34||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-8.34|-13.17|<0.001
70937471|NCT00696241|141374902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.08|||<|0.001|TWO_SIDED|95.0|-14.48|-9.67||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-9.67|-14.48|<0.001
70937472|NCT00696241|141374902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.21|||<|0.001|TWO_SIDED|95.0|-15.62|-10.81||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-10.81|-15.62|<0.001
70937473|NCT00696241|141374902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.687|TWO_SIDED|95.0|-1.55|2.35||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||2.35|-1.55|0.687
70937474|NCT00696241|141374902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||0.352|TWO_SIDED|95.0|-2.87|1.02||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||1.02|-2.87|0.352
70937475|NCT00696241|141374902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06||||0.038|TWO_SIDED|95.0|-4.0|-0.12||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-0.12|-4.00|0.038
70937476|NCT00696241|141374903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.23|||<|0.001|TWO_SIDED|95.0|-15.45|-9.0||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-9.00|-15.45|<0.001
70937477|NCT00696241|141374903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.42|||<|0.001|TWO_SIDED|95.0|-15.64|-9.2||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-9.20|-15.64|<0.001
70937478|NCT00696241|141374903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.53|||<|0.001|TWO_SIDED|95.0|-18.74|-12.31||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-12.31|-18.74|<0.001
70937479|NCT00696241|141374903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.662|TWO_SIDED|95.0|-2.05|3.22||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||3.22|-2.05|0.662
70937480|NCT00696241|141374903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.768|TWO_SIDED|95.0|-2.24|3.03||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||3.03|-2.24|0.768
71111016|NCT01891396|141727967|SUPERIORITY|||||||0.0059|||||||ANOVA|||||||0.0059
71111017|NCT04229888|141727998|NON_INFERIORITY|To establish non-inferiority of the treatment effect on the primary outcome change in DEQ-5 score, the upper bound of the two-sided 95% confidence interval on mean difference between the light based (sham) treatment and Lipiflow treatment were compared against a non-inferiority margin M=6 representing the largest clinically acceptable difference based on historical data.||||||0.02|||||||ANOVA|||||||0.02
70937481|NCT00696241|141374903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.71||||0.043|TWO_SIDED|95.0|-5.34|-0.09||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-0.09|-5.34|0.043
70937482|NCT00696241|141374904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.78|||<|0.001|TWO_SIDED|95.0|-8.34|-5.22||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.22|-8.34|<0.001
70937483|NCT00696241|141374904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.68|||<|0.001|TWO_SIDED|95.0|-9.24|-6.13||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.13|-9.24|<0.001
71063542|NCT00450437|141636034|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.2|||||TWO_SIDED|95.0|0.9|1.6|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.6|0.9|
71078153|NCT03300050|141664645|OTHER||Difference|19.2||||0.4515|TWO_SIDED|95.0|-17.19|50.49|||Fisher Exact|||Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Seroresponse (\>4-Fold) Rate 28 Days Post-Boost Dose||50.49|-17.19|0.4515
71078154|NCT03300050|141664645|OTHER||Difference|14.3||||0.4837|TWO_SIDED|95.0|-21.22|46.19|||Fisher Exact|||Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Seroresponse (\>4-Fold) Rate 28 Days Post-Boost Dose||46.19|-21.22|0.4837
71078155|NCT03300050|141664645|OTHER||Difference|-4.9|||>|0.9999|TWO_SIDED|95.0|-38.8|30.46|||Fisher Exact|||Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Seroresponse (\>4-Fold) Rate 28 Days Post-Boost Dose||30.46|-38.80|>0.9999
71078156|NCT03300050|141664648|OTHER||Difference|2.93||||0.0031|TWO_SIDED|95.0|1.56|7.49|||Wilcoxon (Mann-Whitney)||Based on log10 AUC, using the Hodges-Lehmann location parameter difference back-transformed to the original scale.|Comparison of Serum cH6/1 - ADCC Activity: AUC at 28 Days Post-Boost||7.49|1.56|0.0031
71078157|NCT03300050|141664648|OTHER||Difference|1.25||||0.2048|TWO_SIDED|95.0|0.73|2.23|||Wilcoxon (Mann-Whitney)||Based on log10 AUC, using the Hodges-Lehmann location parameter difference back-transformed to the original scale.|Comparison of Serum cH6/1 - ADCC Activity: AUC at 28 Days Post-Boost||2.23|0.73|0.2048
71078158|NCT03300050|141664648|OTHER||Difference|0.43||||0.0392|TWO_SIDED|95.0|0.18|1.0|||Wilcoxon (Mann-Whitney)|||Comparison of Serum cH6/1 - ADCC Activity: AUC at 28 Days Post-Boost||1.00|0.18|0.0392
71078159|NCT03300050|141664649|OTHER||Difference|1.16||||0.8243|TWO_SIDED|95.0|0.14|4.95|||Wilcoxon (Mann-Whitney)||Based on the Hodges-Lehmann location parameter difference on the log scale then back-transformed to the original scale.|Comparison of Serum cH6/1 - ADCC Activity: Fold Increase in AUC at 28 Days Post-Boost||4.95|0.14|0.8243
71078160|NCT03300050|141664649|OTHER||Difference|1.74||||0.253|TWO_SIDED|95.0|0.67|6.06|||Wilcoxon (Mann-Whitney)||Based on the Hodges-Lehmann location parameter difference on the log scale then back-transformed to the original scale.|Comparison of Serum cH6/1 - ADCC Activity: Fold Increase in AUC at 28 Days Post-Boost||6.06|0.67|0.2530
71078161|NCT03300050|141664649|OTHER||Difference|1.83||||0.5654|TWO_SIDED|95.0|0.47|39.92|||Wilcoxon (Mann-Whitney)||Based on the Hodges-Lehmann location parameter difference on the log scale then back-transformed to the original scale.|Comparison of Serum cH6/1 - ADCC Activity: Fold Increase in AUC at 28 Days Post-Boost||39.92|0.47|0.5654
71078162|NCT03300050|141664653|OTHER||GMT Ratio|1.21||||0.883|TWO_SIDED|95.0|0.45|3.27|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||3.27|0.45|0.8830
71078163|NCT03300050|141664653|OTHER||GMT Ratio|0.86||||0.9238|TWO_SIDED|95.0|0.33|2.26|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||2.26|0.33|0.9238
71078164|NCT03300050|141664653|OTHER||GMT Ratio|0.71||||0.6926|TWO_SIDED|95.0|0.26|1.97|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||1.97|0.26|0.6926
71078165|NCT03300050|141664654|OTHER||Difference|11.7||||0.7036|TWO_SIDED|95.0|-25.72|45.82|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||45.82|-25.72|0.7036
71078166|NCT03300050|141664654|OTHER||Difference|-3.8|||>|0.9999|TWO_SIDED|95.0|-37.9|31.31|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||31.31|-37.90|>0.9999
71078167|NCT03300050|141664654|OTHER||Difference|-15.5||||0.6951|TWO_SIDED|95.0|-49.56|22.79|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||22.79|-49.56|0.6951
71078168|NCT03300050|141664658|OTHER||GMT Ratio|0.65||||0.3203|TWO_SIDED|95.0|0.32|1.33|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days post-Boost Dose||1.33|0.32|0.3203
71078169|NCT03300050|141664658|OTHER||GMT Ratio|0.72||||0.5009|TWO_SIDED|95.0|0.35|1.47|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days post-Boost Dose||1.47|0.35|0.5009
71063543|NCT00450437|141636034|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.33|||||TWO_SIDED|95.0|1.0|1.77|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.77|1|
71063544|NCT00450437|141636034|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.9|||||TWO_SIDED|95.0|0.68|1.2|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.2|0.68|
71063545|NCT00450437|141636034|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.79|||||TWO_SIDED|95.0|0.63|0.97|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain W at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||0.97|0.63|
71063546|NCT00450437|141636034|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.06|||||TWO_SIDED|95.0|0.86|1.13|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.13|0.86|
71063547|NCT00450437|141636034|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.35|||||TWO_SIDED|95.0|1.09|1.67|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.67|1.09|
71063548|NCT00450437|141636034|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.79|||||TWO_SIDED|95.0|0.61|1.02|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain Y at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.02|0.61|
71063549|NCT00450437|141636034|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.91|||||TWO_SIDED|95.0|0.7|1.18|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.18|0.7|
71063550|NCT00450437|141636034|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.16|||||TWO_SIDED|95.0|0.89|1.5|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.5|0.89|
71111018|NCT04229888|141727999|NON_INFERIORITY|To establish non-inferiority of the treatment effect on the primary outcome change in MG score, the upper bound of the two-sided 95% confidence interval on mean difference between the light based (sham) treatment and Lipiflow treatment were compared against a non-inferiority margin M= 1 representing the largest clinically acceptable difference based on historical data.||||||0.07|||||||ANOVA|||||||0.07
71111019|NCT04229888|141728000|NON_INFERIORITY|To establish non-inferiority of the treatment effect on the primary outcome change in TBUT, the upper bound of the two-sided 95% confidence interval on mean difference between the light based (sham) treatment and Lipiflow treatment were compared against a non-inferiority margin M=6 representing the largest clinically acceptable difference based on historical data.||||||0.66|||||||ANOVA|||||||0.66
71111020|NCT01964378|141728005|NON_INFERIORITY|Non-inferiority margin of 8 mg. Assuming equal mean values in both the cebranopadol and morphine groups, it was calculated that for the final analysis of the primary endpoint 170 subjects would have been required per treatment arm in the Per Protocol Set using a 2 sample-t-test for 90% power and a 1-sided significance level of α = 0.025.|point-estimate|-7.48|STANDARD_ERROR_OF_MEAN|2.3|<|0.0001|TWO_SIDED|95.0|-12.05|-2.918|||MMRM|||The MMRM (mixed model repeated measurement) model includes fixed effects of pooled country, treatment, week, treatment-by-week interaction, history of opioid intake, baseline pain intensity as covariate \& subject-specific random effects. Dependent variable being the weekly average rescue medication intake.||-2.918|-12.05|< 0.0001
71111021|NCT01964378|141728006|NON_INFERIORITY|Non-inferiority margin of 8 mg. Assuming that 65% of the participants are available for the Per Protocol Set, a total of 524 participant would have to be allocated (randomized) to IMP. With 262 participants per group in the Full Analysis Set, the non-inferiority of cebranopadol as compared to morphine sulfate prolonged release could have been demonstrated with at least 98% power and a 1-sided significance level of α = 0.025.|point-estimate|-4.67|STANDARD_ERROR_OF_MEAN|2.3|<|0.0001|TWO_SIDED|95.0|-9.245|-0.099||MMRM model: fixed effects of pooled country, treatment, week, treatment-by-week interaction, opioid intake history, baseline pain intensity as covariate \& subject-specific random effects. Dependent variable: weekly average rescue medication intake.|MMRM (mixed model repeated measurement)|For participants with no data in the Maintenance Phase, the average amount of rescue medication over the last 3 days of titration was imputed.|Non-inferiority of cebranopadol compared with morphine will be established if the upper bound of the resulting 95% confidence interval for the average treatment difference is below the non-inferiority margin of 8mg.|The primary endpoint will be analyzed by means of a mixed-effects model for repeated measures (MMRM), based on observed case weekly averages. Under the assumption of a missing-at-random missing data mechanism, an MMRM does not require an imputation of missing data and can obtain an improved estimate of variance.||-0.099|-9.245|< 0.0001
71111022|NCT03542266|141728019|OTHER||Proportion (percent)|75.0|||||TWO_SIDED|95.0|46.5|90.3|||||Exact (Clopper-Pearson) 95% confidence interval for complete response rate.|||90.3|46.5|
70937484|NCT00696241|141374904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.92|||<|0.001|TWO_SIDED|95.0|-9.47|-6.36||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.36|-9.47|<0.001
70937485|NCT00696241|141374904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.679|TWO_SIDED|95.0|-0.99|1.52||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.52|-0.99|0.679
70937486|NCT00696241|141374904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.319|TWO_SIDED|95.0|-1.89|0.62||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.62|-1.89|0.319
70937487|NCT00696241|141374904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87||||0.172|TWO_SIDED|95.0|-2.13|0.38||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.38|-2.13|0.172
71063551|NCT00450437|141636035|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|8.0|||||TWO_SIDED|95.0|3.0|14.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.||14|3|
71063552|NCT00450437|141636035|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.0|7.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenC.||7|-2|
71063553|NCT00450437|141636035|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|12.0|||||TWO_SIDED|95.0|6.0|18.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenW.||18|6|
71111023|NCT00149799|141728025|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.73||||0.048|TWO_SIDED|95.0|1.01|8.59|||Regression, Cox|p-value is based on the likelihood ratio Chi-Square statistic.||Cox proportional hazards regression was used to compare relapse rates (accounting for censoring and time from randomization to relapse) in Phase II.||8.59|1.01|0.048
71111024|NCT00149799|141728027|SUPERIORITY||Slope difference|-0.07006|STANDARD_ERROR_OF_MEAN|0.04163||0.093|TWO_SIDED|||||A priori threshold for statistical significance: 0.0167 Model term of interest: treatment by time interaction (i.e., slope difference between treatments over time)|Mixed Models Analysis|Degrees of freedom=556||"We compared change in depression over time by randomized treatment group (Escitalopram vs. Placebo) using a random coefficient model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in depression symptom severity in the Escitalopram group will not be significantly different from the placebo group \[to be tested\]."||||0.0930
70937488|NCT00696241|141374905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.02|||<|0.001|TWO_SIDED|95.0|-8.83|-5.22||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.22|-8.83|<0.001
71063554|NCT00450437|141636035|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|27.0|||||TWO_SIDED|95.0|20.0|33.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.||33|20|
71063555|NCT00450437|141636036|NON_INFERIORITY_OR_EQUIVALENCE|MenACWY was considered noninferior to Menactra if the upper limit of the two-sided 95% CI of the difference in the percentage of subjects experiencing at least one severe systemic reaction \[MenACWY minus Menactra\] was less than 6%.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-1.0|2.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, safety.||2|-1|
71063556|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-10.0|3.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||3|-10|
71063557|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-6.0|||||TWO_SIDED|95.0|-12.0|0.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||0|-12|
71063558|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-9.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||4|-9|
71063559|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|5.0|||||TWO_SIDED|95.0|0.0|10.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||10|0|
71063560|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|4.0|||||TWO_SIDED|95.0|-1.0|10.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||10|-1|
71078170|NCT03300050|141664658|OTHER||GMT Ratio|1.1||||0.9542|TWO_SIDED|95.0|0.51|2.37|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days post-Boost Dose||2.37|0.51|0.9542
71078171|NCT03300050|141664659|OTHER||Difference|-1.7|||>|0.9999|TWO_SIDED|95.0|-30.62|23.79|||Fisher Exact|||Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days post-Boost Dose||23.79|-30.62|>0.9999
71078172|NCT03300050|141664659|OTHER||Difference|6.7|||>|0.9999|TWO_SIDED|95.0|-16.24|30.34|||Fisher Exact|||Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days post-Boost Dose||30.34|-16.24|>0.9999
71078173|NCT03300050|141664659|OTHER||Difference|8.3||||0.4615|TWO_SIDED|95.0|-19.94|36.04|||Fisher Exact|||Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days post-Boost Dose||36.04|-19.94|0.4615
71078174|NCT03300050|141664663|OTHER||GMT Ratio|1.2||||0.9164|TWO_SIDED|95.0|0.38|3.8|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||3.80|0.38|0.9164
71078175|NCT03300050|141664663|OTHER||GMT Ratio|0.76||||0.8642|TWO_SIDED|95.0|0.21|2.79|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||2.79|0.21|0.8642
70937489|NCT00696241|141374905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.07|||<|0.001|TWO_SIDED|95.0|-8.87|-5.27||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.27|-8.87|<0.001
70937490|NCT00696241|141374905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.62|||<|0.001|TWO_SIDED|95.0|-10.42|-6.82||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.82|-10.42|<0.001
70937491|NCT00696241|141374905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.908|TWO_SIDED|95.0|-1.39|1.56||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.56|-1.39|0.908
70937492|NCT00696241|141374905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.956|TWO_SIDED|95.0|-1.43|1.52||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.52|-1.43|0.956
70937493|NCT00696241|141374905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51||||0.044|TWO_SIDED|95.0|-2.98|-0.04||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.04|-2.98|0.044
70937494|NCT00696241|141374906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.03|||<|0.001|TWO_SIDED|95.0|-13.59|-8.48||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.48|-13.59|<0.001
70937495|NCT00696241|141374906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.2|||<|0.001|TWO_SIDED|95.0|-14.75|-9.65||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.65|-14.75|<0.001
70937496|NCT00696241|141374906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.41|||<|0.001|TWO_SIDED|95.0|-15.97|-10.86||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-10.86|-15.97|<0.001
70937497|NCT00696241|141374906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.879|TWO_SIDED|95.0|-1.9|2.22||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.22|-1.90|0.879
70937498|NCT00696241|141374906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.334|TWO_SIDED|95.0|-3.07|1.04||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.04|-3.07|0.334
70937499|NCT00696241|141374906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.22||||0.034|TWO_SIDED|95.0|-4.28|-0.16||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.16|-4.28|0.034
71063561|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|-1.0|||||TWO_SIDED|95.0|-6.0|5.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||5|-6|
71063562|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|-6.0|||||TWO_SIDED|95.0|-13.0|0.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||0|-13|
71078176|NCT03300050|141664663|OTHER||GMT Ratio|0.63||||0.6545|TWO_SIDED|95.0|0.18|2.27|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||2.27|0.18|0.6545
70937500|NCT00696241|141374907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.12|||<|0.001|TWO_SIDED|95.0|-8.79|-5.45||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.45|-8.79|<0.001
70937501|NCT00696241|141374907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.84|||<|0.001|TWO_SIDED|95.0|-9.51|-6.18||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.18|-9.51|<0.001
70937502|NCT00696241|141374907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.28|||<|0.001|TWO_SIDED|95.0|-9.94|-6.61||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.61|-9.94|<0.001
70937503|NCT00696241|141374907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.877|TWO_SIDED|95.0|-1.24|1.45||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.45|-1.24|0.877
71078177|NCT03300050|141664664|OTHER||Difference|7.7|||>|0.9999|TWO_SIDED|95.0|-27.1|40.96|||Fisher Exact|||Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Seroresponse (\>4-Fold) Rate 28 Days Post-Boost Dose||40.96|-27.10|>0.9999
71078178|NCT03300050|141664664|OTHER||Difference|30.8||||0.1045|TWO_SIDED|95.0|-1.76|58.19|||Fisher Exact|||Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||58.19|-1.76|0.1045
71078179|NCT03300050|141664664|OTHER||Difference|23.1||||0.2292|TWO_SIDED|95.0|-8.62|50.86|||Fisher Exact|||Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||50.86|-8.62|0.2292
71078180|NCT03517449|141664756|SUPERIORITY||Hazard Ratio (HR)|0.56|||<|0.0001|TWO_SIDED|95.0|0.47|0.66|||Log Rank||Regression, Cox method|||0.66|0.47|<0.0001
70852586|NCT02123251|141194066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1188|STANDARD_ERROR_OF_MEAN|1.031||0.0399|TWO_SIDED|95.0|0.0981|4.1395|||Generalized Estimating Equation Model|The effect of age and gender is adjusted in the GEE model.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|The average change in scores over time for the intervention group was compared to that of the control group. The difference in the average changes is referred to as the difference-in-differences values which was assessed for significance at p=0.05. Null assumed no group difference in the Physical Component Summary measure of SF-36v2 from baseline to midpoint. Generalized estimating equation (GEE) modeling was used to examine changes in health measures between groups at different time points.||4.1395|0.0981|.0399
70937504|NCT00696241|141374907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.369|TWO_SIDED|95.0|-1.96|0.73||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.73|-1.96|0.369
71063563|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|4.0|||||TWO_SIDED|95.0|-3.0|11.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||11|-3|
71063564|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|10.0|||||TWO_SIDED|95.0|4.0|17.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||17|4|
71063565|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-6.0|||||TWO_SIDED|95.0|-13.0|1.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||1|-13|
71063566|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-6.0|8.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||8|-6|
71063567|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|7.0|||||TWO_SIDED|95.0|0.0|14.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||14|0|
71063568|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-10.0|3.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||3|-10|
71078181|NCT03517449|141664757|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.51|0.75|||Log Rank||Regression, Cox method|||0.75|0.51|<0.0001
71078182|NCT03517449|141664758|SUPERIORITY||Difference in Percent|17.2|||<|0.0001|TWO_SIDED|95.0|11.5|22.9|||Miettinen & Nurminen method|||||22.9|11.5|<0.0001
71078183|NCT01119846|141664770|SUPERIORITY_OR_OTHER||Slope|0.5782|||||TWO_SIDED|90.0|0.523|0.6335|||||Dose Proportionality for GSK1292263 Using the Power Model.|||0.6335|0.5230|
71078184|NCT01119846|141664772|SUPERIORITY_OR_OTHER||Slope|0.5828|||||TWO_SIDED|90.0|0.5282|0.6375|||||Dose Proportionality for GSK1292263 Using the Power Model for AUC0-24.|||0.6375|0.5282|
71078185|NCT01119846|141664772|SUPERIORITY_OR_OTHER||Slope|0.5808|||||TWO_SIDED|90.0|0.5325|0.6291|||||Dose Proportionality for GSK1292263 Using the Power Model for AUC0-last.|||0.6291|0.5325|
71078186|NCT01119846|141664787|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.036|||||TWO_SIDED|95.0|-1.17|1.1||||||||1.10|-1.17|
70852587|NCT04672954|141194070|OTHER||Ratio|1.29||||0.3941|TWO_SIDED|90.0|0.78|2.13|||ANCOVA||Ratio = BI / Placebo. Geometric standard error = 1.34|The difference between the expected means for ln(T) - ln(R) was estimated by the difference in the corresponding least square means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were back-transformed to the original scale to give the point estimator and interval estimates.||2.13|0.78|0.3941
71063569|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-6.0|||||TWO_SIDED|95.0|-12.0|0.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||0|-12|
71063570|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-9.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||4|-9|
71063571|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|2.0|||||TWO_SIDED|95.0|-3.0|6.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||6|-3|
71063572|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|3.0|||||TWO_SIDED|95.0|-2.0|7.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||7|-2|
71063573|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-3.0|6.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||6|-3|
71063574|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|-2.0|||||TWO_SIDED|95.0|-5.0|1.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||1|-5|
71063575|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|-1.0|||||TWO_SIDED|95.0|-4.0|2.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||2|-4|
71078187|NCT01119846|141664787|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.225|||||TWO_SIDED|95.0|-0.9|1.35||||||||1.35|-0.90|
71078188|NCT01119846|141664787|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.046|||||TWO_SIDED|95.0|-1.1|1.19||||||||1.19|-1.10|
71078189|NCT01119846|141664787|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.679|||||TWO_SIDED|95.0|-1.8|0.45||||||||0.45|-1.80|
71078190|NCT01119846|141664788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|||||TWO_SIDED|95.0|-1.8|2.33|||||Comparison of AUC(0-24)|||2.33|-1.80|
71078191|NCT01119846|141664788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.614|||||TWO_SIDED|95.0|-1.53|2.76|||||Comparison of AUC(0-24)|||2.76|-1.53|
71078192|NCT01119846|141664788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.451|||||TWO_SIDED|95.0|-1.64|2.54|||||Comparison of AUC(0-24)|||2.54|-1.64|
71078193|NCT01119846|141664788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.469|||||TWO_SIDED|95.0|-1.39|2.33|||||Comparison of AUC(0-24)|||2.33|-1.39|
71078194|NCT01119846|141664788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29|||||TWO_SIDED|95.0|-2.53|1.95|||||Comparison of AUC(0-13)|||1.95|-2.53|
71078195|NCT01119846|141664788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.026|||||TWO_SIDED|95.0|-2.35|2.3|||||Comparison of AUC(0-13)|||2.30|-2.35|
71078196|NCT01119846|141664788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.163|||||TWO_SIDED|95.0|-2.48|2.15|||||Comparison of AUC(0-13)|||2.15|-2.48|
71078197|NCT01119846|141664788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|||||TWO_SIDED|95.0|-1.88|2.21|||||Comparison of AUC(0-13)|||2.21|-1.88|
70937505|NCT00696241|141374907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05||||0.126|TWO_SIDED|95.0|-2.39|0.3||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.30|-2.39|0.126
70937506|NCT00696241|141374908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.13|||<|0.001|TWO_SIDED|95.0|-12.79|-7.48||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.48|-12.79|<0.001
70937507|NCT00696241|141374908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.43|||<|0.001|TWO_SIDED|95.0|-14.07|-8.78||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.78|-14.07|<0.001
70937508|NCT00696241|141374908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.38|||<|0.001|TWO_SIDED|95.0|-15.03|-9.73||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.73|-15.03|<0.001
70937509|NCT00696241|141374908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03||||0.346|TWO_SIDED|95.0|-1.12|3.18||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.18|-1.12|0.346
70937510|NCT00696241|141374908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.811|TWO_SIDED|95.0|-2.4|1.88||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.88|-2.40|0.811
70937511|NCT00696241|141374908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.267|TWO_SIDED|95.0|-3.35|0.93||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.93|-3.35|0.267
71111025|NCT00149799|141728028|SUPERIORITY||Slope difference|0.001176|STANDARD_ERROR_OF_MEAN|0.03991||0.9766|TWO_SIDED|||||A priori threshold for statistical significance: 0.0167 Model term of interest: treatment by time interaction (i.e., slope difference between treatments over time)|Mixed Models Analysis|Degrees of freedom=43||"We compared change in functional impairment over time during trial phase 2 by treatment group (Escitalopram vs. Placebo) using a random coefficient model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in functional impairment in the Escitalopram group will not be significantly different from that of the placebo group \[to be tested\]."||||0.9766
70937512|NCT00696241|141374909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.03|||<|0.001|TWO_SIDED|95.0|-7.84|-4.21||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.21|-7.84|<0.001
70937513|NCT00696241|141374909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.94|||<|0.001|TWO_SIDED|95.0|-8.75|-5.13||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.13|-8.75|<0.001
70937514|NCT00696241|141374909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.84|||<|0.001|TWO_SIDED|95.0|-8.65|-5.03||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.03|-8.65|<0.001
70937515|NCT00696241|141374909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64||||0.394|TWO_SIDED|95.0|-0.83|2.1||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.10|-0.83|0.394
70937516|NCT00696241|141374909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.712|TWO_SIDED|95.0|-1.74|1.19||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.19|-1.74|0.712
70937517|NCT00696241|141374909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.818|TWO_SIDED|95.0|-1.63|1.29||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.29|-1.63|0.818
70937518|NCT00696241|141374910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.35|||<|0.001|TWO_SIDED|95.0|-14.05|-8.64||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.64|-14.05|<0.001
70937519|NCT00696241|141374910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.68|||<|0.001|TWO_SIDED|95.0|-15.38|-9.98||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.98|-15.38|<0.001
70937520|NCT00696241|141374910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.81|||<|0.001|TWO_SIDED|95.0|-16.51|-11.11||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-11.11|-16.51|<0.001
70937521|NCT00696241|141374910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.75|TWO_SIDED|95.0|-1.83|2.54||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.54|-1.83|0.750
70937522|NCT00696241|141374910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98||||0.378|TWO_SIDED|95.0|-3.16|1.2||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.20|-3.16|0.378
70937523|NCT00696241|141374910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.059|TWO_SIDED|95.0|-4.28|0.08||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.08|-4.28|0.059
70937524|NCT00696241|141374911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.25|||<|0.001|TWO_SIDED|95.0|-9.02|-5.48||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.48|-9.02|<0.001
71063576|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||4|-2|
71063577|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-8.0|2.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||2|-8|
71078198|NCT01119846|141664788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.352|||||TWO_SIDED|95.0|-1.58|0.87|||||Comparison of iAUC(0-13)|||0.87|-1.58|
71078199|NCT01119846|141664788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.136|||||TWO_SIDED|95.0|-1.41|1.13|||||Comparison of iAUC(0-13)|||1.13|-1.41|
71078200|NCT01119846|141664788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.091|||||TWO_SIDED|95.0|-1.36|1.18|||||Comparison of iAUC(0-13)|||1.18|-1.36|
71078201|NCT01119846|141664788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.206|||||TWO_SIDED|95.0|-1.33|0.91|||||Comparison of iAUC(0-13)|||0.91|-1.33|
71078202|NCT01119846|141664788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.499|||||TWO_SIDED|95.0|-1.68|0.68|||||Comparison of iAUC(0-24)|||0.68|-1.68|
71078203|NCT01119846|141664788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.017|||||TWO_SIDED|95.0|-1.24|1.21|||||Comparison of iAUC(0-24)|||1.21|-1.24|
71078204|NCT01119846|141664788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.247|||||TWO_SIDED|95.0|-1.44|0.95|||||Comparison of iAUC(0-24)|||0.95|-1.44|
71078205|NCT01119846|141664788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.661|||||TWO_SIDED|95.0|-1.72|0.4|||||Comparison of iAUC(0-24)|||0.40|-1.72|
71078206|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-49.898|||||TWO_SIDED|95.0|-479.74|379.94|||||Comparison of C-peptide, AUC 0-12|||379.94|-479.74|
71078207|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-61.642|||||TWO_SIDED|95.0|-507.32|384.04|||||Comparison of C-peptide, AUC 0-12|||384.04|-507.32|
71078208|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-85.849|||||TWO_SIDED|95.0|-530.07|358.37|||||Comparison of C-peptide, AUC 0-12|||358.37|-530.07|
71078209|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-101.422|||||TWO_SIDED|95.0|-494.09|291.25|||||Comparison of C-peptide, AUC 0-12|||291.25|-494.09|
71078210|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.239|||||TWO_SIDED|95.0|-340.32|261.85|||||Comparison of C-peptide, iAUC 0-12|||261.85|-340.32|
71078211|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-117.435|||||TWO_SIDED|95.0|-429.61|194.74|||||Comparison of C-peptide, iAUC 0-12|||194.74|-429.61|
71078212|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-121.982|||||TWO_SIDED|95.0|-433.14|189.18|||||Comparison of C-peptide, iAUC 0-12|||189.18|-433.14|
71078213|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-81.016|||||TWO_SIDED|95.0|-356.07|194.03|||||Comparison of C-peptide, iAUC 0-12|||194.03|-356.07|
71078214|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.812|||||TWO_SIDED|95.0|-8.08|13.7|||||Comparison of GIP total, AUC 0-12|||13.70|-8.08|
71078215|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.023|||||TWO_SIDED|95.0|-8.27|14.32|||||Comparison of GIP total, AUC 0-12|||14.32|-8.27|
71078216|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.483|||||TWO_SIDED|95.0|0.23|22.74|||||Comparison of GIP total, AUC 0-12|||22.74|0.23|
71078217|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.093|||||TWO_SIDED|95.0|-17.04|2.86|||||Comparison of GIP total, AUC 0-12|||2.86|-17.04|
71078218|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||||TWO_SIDED|95.0|-7.28|12.28|||||Comparison of GIP total, iAUC 0-12|||12.28|-7.28|
71078219|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.526|||||TWO_SIDED|95.0|-6.61|13.67|||||Comparison of GIP total, iAUC 0-12|||13.67|-6.61|
71078220|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.934|||||TWO_SIDED|95.0|-2.17|18.04|||||Comparison of GIP total, iAUC 0-12|||18.04|-2.17|
71078221|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.055|||||TWO_SIDED|95.0|-15.99|1.88|||||Comparison of GIP total, iAUC 0-12|||1.88|-15.99|
71078222|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.018|||||TWO_SIDED|95.0|-0.79|0.76|||||Comparison of GLP-1 active, AUC 0-12|||0.76|-0.79|
71078223|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|||||TWO_SIDED|95.0|-0.78|0.82|||||Comparison of GLP-1 active, AUC 0-12|||0.82|-0.78|
71078224|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|||||TWO_SIDED|95.0|-0.78|0.85|||||Comparison of GLP-1 active, AUC 0-12|||0.85|-0.78|
71078225|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.454|||||TWO_SIDED|95.0|2.74|4.17|||||Comparison of GLP-1 active, AUC 0-12|||4.17|2.74|
71078226|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|||||TWO_SIDED|95.0|-0.78|0.75|||||Comparison of GLP-1 active, iAUC 0-12|||0.75|-0.78|
71078227|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.006|||||TWO_SIDED|95.0|-0.79|0.8|||||Comparison of GLP-1 active, iAUC 0-12|||0.80|-0.79|
71078228|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.018|||||TWO_SIDED|95.0|-0.79|0.83|||||Comparison of GLP-1 active, iAUC 0-12|||0.83|-0.79|
71078229|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.399|||||TWO_SIDED|95.0|2.69|4.11|||||Comparison of GLP-1 active, iAUC 0-12|||4.11|2.69|
71078230|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|||||TWO_SIDED|95.0|-2.06|2.17|||||Comparison of GLP-1 total, AUC 0-12|||2.17|-2.06|
70937525|NCT00696241|141374911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.16|||<|0.001|TWO_SIDED|95.0|-9.92|-6.4||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.40|-9.92|<0.001
70937526|NCT00696241|141374911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.41|||<|0.001|TWO_SIDED|95.0|-10.17|-6.65||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.65|-10.17|<0.001
70937527|NCT00696241|141374911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.845|TWO_SIDED|95.0|-1.29|1.57||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.57|-1.29|0.845
70937528|NCT00696241|141374911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77||||0.29|TWO_SIDED|95.0|-2.19|0.65||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.65|-2.19|0.290
70937529|NCT00696241|141374911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02||||0.161|TWO_SIDED|95.0|-2.44|0.41||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.41|-2.44|0.161
70937530|NCT00696241|141374912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.94|||<|0.001|TWO_SIDED|95.0|-13.88|-8.0||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.00|-13.88|<0.001
70937531|NCT00696241|141374912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.18|||<|0.001|TWO_SIDED|95.0|-14.11|-8.24||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.24|-14.11|<0.001
70937532|NCT00696241|141374912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.21|||<|0.001|TWO_SIDED|95.0|-15.15|-9.28||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.28|-15.15|<0.001
70937533|NCT00696241|141374912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05||||0.385|TWO_SIDED|95.0|-3.43|1.33||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.33|-3.43|0.385
71063578|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-8.0|2.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||2|-8|
71063579|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-5.0|5.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||5|-5|
71078231|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.223|||||TWO_SIDED|95.0|-1.97|2.42|||||Comparison of GLP-1 total, AUC 0-12|||2.42|-1.97|
70937534|NCT00696241|141374912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29||||0.285|TWO_SIDED|95.0|-3.66|1.08||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.08|-3.66|0.285
70937535|NCT00696241|141374912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33||||0.054|TWO_SIDED|95.0|-4.7|0.04||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.04|-4.70|0.054
71078232|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.835|||||TWO_SIDED|95.0|-0.35|4.02|||||Comparison of GLP-1 total, AUC 0-12|||4.02|-0.35|
71078233|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.629|||||TWO_SIDED|95.0|-3.56|0.3|||||Comparison of GLP-1 total, AUC 0-12|||0.30|-3.56|
71078234|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|||||TWO_SIDED|95.0|-1.7|1.86|||||Comparison of GLP-1 total, iAUC 0-12|||1.86|-1.70|
71078235|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.286|||||TWO_SIDED|95.0|-1.56|2.13|||||Comparison of GLP-1 total, iAUC 0-12|||2.13|-1.56|
71078236|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.764|||||TWO_SIDED|95.0|-1.08|2.6|||||Comparison of GLP-1 total, iAUC 0-12|||2.60|-1.08|
71078237|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.336|||||TWO_SIDED|95.0|-2.96|0.29|||||Comparison of GLP-1 total, iAUC 0-12|||0.29|-2.96|
71078238|NCT01119846|141664789|SUPERIORITY||Mean Difference (Final Values)|0.962|||||TWO_SIDED|95.0|-4.26|6.18|||||Comparison of Glucagon, AUC 0-12|||6.18|-4.26|
71078239|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.067|||||TWO_SIDED|95.0|-2.56|8.69|||||Comparison of Glucagon, AUC 0-12|||8.69|-2.56|
71078240|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.517|||||TWO_SIDED|95.0|-2.98|8.01|||||Comparison of Glucagon, AUC 0-12|||8.01|-2.98|
71078241|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.714|||||TWO_SIDED|95.0|-5.56|4.13|||||Comparison of Glucagon, AUC 0-12|||4.13|-5.56|
71111026|NCT00149799|141728029|SUPERIORITY||Slope difference|0.05723|STANDARD_ERROR_OF_MEAN|0.1963||0.7724|TWO_SIDED|||||A priori threshold for statistical significance: 0.0167 Model term of interest: treatment by time interaction (i.e., slope difference between treatments over time)|Mixed Models Analysis|Degrees of freedom=36||"We compared change in Q-LES-Q-SF percent scores over time by randomized treatment group (Escitalopram vs. Placebo) using a random coefficient model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in Q-LES-Q-SF percent scores in the Escitalopram group will not be significantly different from that of the placebo group \[to be tested\]."||||0.7724
71111027|NCT01072136|141728031|NON_INFERIORITY_OR_EQUIVALENCE|Under the assumption of a clinical cure proportion of 75% for the Azithromycin/Cefixime group, a 10% non-inferiority margin (i.e., no more than a 10% lower cure rate in the placebo group) at the one-sided 0.05 significance level with 85% power required 270 study participants in each arm (540 total) using an unpooled Z-test (normal approximation). Anticipating that approximately 30% of enrolled participants would not be in the per protocol group, 772 participants were targeted for enrollment.|Risk Difference (RD)|14.0|||||ONE_SIDED|95.0|-12.2||||||Asymptotic one-sided 95% confidence limit for the difference in clinical cure proportions(placebo minus treatment) were computed so that the lower limit could be examined relative to the non-inferiority margin of -10%.|The primary efficacy outcome was MPC clinical cure at 2 months. This was a non-inferiority trial designed to reject the null hypothesis that placebo control is inferior to empiric therapy for MPC.|||-12.2|
71111028|NCT01392573|141728051|SUPERIORITY_OR_OTHER||Treatment contrast|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.25|-0.84|||ANCOVA|ANCOVA model with treatment, country and previous antidiabetic treatment as fixed effects and baseline HbA1c value as covariate||||-0.84|-1.25|<0.0001
71111029|NCT03008070|141728053|SUPERIORITY||Risk Ratio (RR)|1.52|||=|0.061|TWO_SIDED|95.0|0.98|2.12|||Cochran-Mantel-Haenszel|||"The primary endpoint was a binary outcome (Yes/No). Responders rates were compared between the placebo and lanifibranor 800 mg at the end of the treatment period (week 24) using a Cochran Mantel Haenzel test stratified on diabetic status at baseline (that was the stratified factors in the randomisation).~The CMH risk ratio is used to estimate the effect size. Patients with missing data are considered as non-responders."||2.12|0.98|=0.061
71111030|NCT03008070|141728053|SUPERIORITY||Risk Ratio (RR)|1.82|||=|0.004|TWO_SIDED|95.0|1.24|2.4|||Cochran-Mantel-Haenszel|||"The primary endpoint was a binary outcome (Yes/No). Responders rates were compared between the placebo and lanifibranor 1200 mg at the end of the treatment period (week 24) using a Cochran Mantel Haenzel test stratified on diabetic status at baseline (that was the stratified factors in the randomisation).~The CMH risk ratio is used to estimate the effect size. Patients with missing data are considered as non-responders."||2.4|1.24|=0.004
71111031|NCT00841412|141728081|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76|||<|0.05|TWO_SIDED|95.0|0.59|0.96|||Mixed Models Analysis||The above results are for just one of multiple feeding assistance care process measures: proportion of meals during which residents received assistance to eat baseline to post intervention.|||0.96|0.59|<0.05
71111032|NCT04409834|141728082|SUPERIORITY|"Stratified Win-Ratio Analysis, 2-sided~* The estimated win ratio is calculated by taking the total number of wins in the FDAC arm divided by the total number of wins in the SDPAC arm. A win ratio greater than 1 was in favor of the FDAC arm.~* The win ratio methodology is explained in the following reference Pocock et al. Eur Heart J 2012;33:176-82 (doi:10.1093/eurheartj/ehr352)."|Win Ratio|1.95||||0.028|TWO_SIDED|95.0|1.08|3.55|||Stratified Win-Ratio Analysis, 2-sided|||FDAC = Full Dose Anticoagulation; SDPAC = Standard Dose Prophylactic Anticoagulation||3.55|1.08|0.028
71111033|NCT04409834|141728083|SUPERIORITY|"Stratified Win-Ratio Analysis, 2-sided~* The estimated win ratio is calculated by taking the total number of wins in the FDAC arm divided by the total number of wins in the SDPAC arm. A win ratio greater than 1 was in favor of the FDAC arm.~* The win ratio methodology is explained in the following reference Pocock et al. Eur Heart J 2012;33:176-82 (doi:10.1093/eurheartj/ehr352)."|Win Ratio|1.79||||0.087|TWO_SIDED|95.0|0.92|3.47|||Stratified Win-Ratio Analysis, 2-sided|||FDAC = Full Dose Anticoagulation; SDPAC = Standard Dose Prophylactic Anticoagulation||3.47|0.92|0.087
71111034|NCT04409834|141728084|SUPERIORITY|"Stratified Win-Ratio Analysis, 2-sided~* The estimated win ratio is calculated by taking the total number of wins in the Anti-platelet arm divided by the total number of wins in the No Anti-platelet arm. A win ratio greater than 1 was in favor of the Anti-platelet arm.~* The win ratio methodology is explained in the following reference Pocock et al. Eur Heart J 2012;33:176-82 (doi:10.1093/eurheartj/ehr352)."|Win Ratio|1.04||||0.9|TWO_SIDED|95.0|0.54|2.01|||Stratified Win-Ratio Analysis, 2-sided|||||2.01|0.54|0.90
71111035|NCT04409834|141728085|SUPERIORITY|"Stratified Win-Ratio Analysis, 2-sided~* The estimated win ratio is calculated by taking the total number of wins in the Anti-platelet arm divided by the total number of wins in the No Anti-platelet arm. A win ratio greater than 1 was in favor of the Anti-platelet arm.~* The win ratio methodology is explained in the following reference Pocock et al. Eur Heart J 2012;33:176-82 (doi:10.1093/eurheartj/ehr352)."|Win Ratio|0.79||||0.53|TWO_SIDED|95.0|0.38|1.65|||Stratified Win-Ratio Analysis, 2-sided|||||1.65|0.38|0.53
71111036|NCT00928187|141728107|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesizing 80% efficacy at the 50 copies/mL Viral Load (VL) threshold in the control group at W48, we calculated a required sample size of 150 participants per group to show non-inferiority of ABC/ddI and DRV groups compared with control group in ITT analysis, with a non-inferiority margin of 15%, a power of 90% and a two-sided α of 5%.|differences in proportions|5.6|||||TWO_SIDED|95.0|-5.1|16.4||||||||16.4|-5.1|
71111037|NCT00928187|141728107|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesizing 80% efficacy at the 50 copies/mL VL threshold in the control group at W48, we calculated a required sample size of 150 participants per group to show non-inferiority of ABC/ddI and DRV groups compared with control group in ITT analysis, with a non-inferiority margin of 15%, a power of 90% and a two-sided α of 5%.|difference in proportions|6.1|||||TWO_SIDED|95.0|-4.5|16.7||||||||16.7|-4.5|
71111038|NCT00928187|141728112|SUPERIORITY_OR_OTHER|||||||0.001|||||||Chi-squared|||||||0.001
71111039|NCT00928187|141728113|SUPERIORITY_OR_OTHER|||||||0.26|||||||Chi-squared|||||||0.26
71063580|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-2.0|||||TWO_SIDED|95.0|-9.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||4|-9|
71078242|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.866|||||TWO_SIDED|95.0|-6.4|0.67|||||Comparison of Glucagon, iAUC 0-12|||0.67|-6.40|
71078243|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.865|||||TWO_SIDED|95.0|-4.68|2.95|||||Comparison of Glucagon, iAUC 0-12|||2.95|-4.68|
71078244|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.436|||||TWO_SIDED|95.0|-4.16|3.29|||||Comparison of Glucagon, iAUC 0-12|||3.29|-4.16|
71078245|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.573|||||TWO_SIDED|95.0|-4.86|1.71|||||Comparison of Glucagon, iAUC 0-12|||1.71|-4.86|
71078246|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.74|||||TWO_SIDED|95.0|-168.38|118.9|||||Comparison of Insulin, AUC 0-13|||118.90|-168.38|
71078247|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.229|||||TWO_SIDED|95.0|-161.16|136.7|||||Comparison of Insulin, AUC 0-13|||136.70|-161.16|
71078248|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.628|||||TWO_SIDED|95.0|-158.07|138.81|||||Comparison of Insulin, AUC 0-13|||138.81|-158.07|
71078249|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-66.936|||||TWO_SIDED|95.0|-198.15|64.28|||||Comparison of Insulin, AUC 0-13|||64.28|-198.15|
71078250|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.042|||||TWO_SIDED|95.0|-150.57|78.48|||||Comparison of Insulin, iAUC 0-13|||78.48|-150.57|
71078251|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.525|||||TWO_SIDED|95.0|-141.27|96.22|||||Comparison of Insulin, iAUC 0-13|||96.22|-141.27|
71078252|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.0|||||TWO_SIDED|95.0|-140.36|96.36|||||Comparison of Insulin, iAUC 0-13|||96.36|-140.36|
71078253|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-66.324|||||TWO_SIDED|95.0|-170.95|38.3|||||Comparison of Insulin, iAUC 0-13|||38.30|-170.95|
71078254|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.982|||||TWO_SIDED|95.0|-2.66|14.62|||||Comparison of PYY total, AUC 0-12|||14.62|-2.66|
71078255|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.908|||||TWO_SIDED|95.0|-0.05|17.86|||||Comparison of PYY total, AUC 0-12|||17.86|-0.05|
71078256|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.317|||||TWO_SIDED|95.0|5.39|23.24|||||Comparison of PYY total, AUC 0-12|||23.24|5.39|
71078257|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.44|||||TWO_SIDED|95.0|-13.33|2.45|||||Comparison of PYY total, AUC 0-12|||2.45|-13.33|
71078258|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.999|||||TWO_SIDED|95.0|-1.87|11.87|||||Comparison of PYY total, iAUC 0-12|||11.87|-1.87|
71078259|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.909|||||TWO_SIDED|95.0|-0.22|14.03|||||Comparison of PYY total, iAUC 0-12|||14.03|-0.22|
71078260|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.036|||||TWO_SIDED|95.0|1.93|16.14|||||Comparison of PYY total, iAUC 0-12|||16.14|1.93|
71078261|NCT01119846|141664789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.39|||||TWO_SIDED|95.0|-12.67|-0.11|||||Comparison of PYY total, iAUC 0-12|||-0.11|-12.67|
71078262|NCT01119846|141664790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.564|||||TWO_SIDED|95.0|-2.69|1.56|||||Comparison of AUC 0-3|||1.56|-2.69|
71078263|NCT01119846|141664790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.846|||||TWO_SIDED|95.0|-3.05|1.36|||||Comparison of AUC 0-3|||1.36|-3.05|
71078264|NCT01119846|141664790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.175|||||TWO_SIDED|95.0|-3.37|1.02|||||Comparison of AUC 0-3|||1.02|-3.37|
71078265|NCT01119846|141664790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.617|||||TWO_SIDED|95.0|-2.56|1.33|||||Comparison of AUC 0-3|||1.33|-2.56|
71078266|NCT01119846|141664790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.626|||||TWO_SIDED|95.0|-1.64|0.39|||||Comparison of iAUC 0-3|||0.39|-1.64|
71078267|NCT01119846|141664790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.956|||||TWO_SIDED|95.0|-2.01|0.09|||||Comparison of iAUC 0-3|||0.09|-2.01|
71078268|NCT01119846|141664790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.103|||||TWO_SIDED|95.0|-2.15|-0.06|||||Comparison of iAUC 0-3|||-0.06|-2.15|
70937536|NCT00696241|141374913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.84|||<|0.001|TWO_SIDED|95.0|-8.93|-4.75||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.75|-8.93|<0.001
70937537|NCT00696241|141374913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.8|||<|0.001|TWO_SIDED|95.0|-8.89|-4.72||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.72|-8.89|<0.001
70937538|NCT00696241|141374913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.55|||<|0.001|TWO_SIDED|95.0|-9.64|-5.47||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.47|-9.64|<0.001
70937539|NCT00696241|141374913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.642|TWO_SIDED|95.0|-2.09|1.29||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.29|-2.09|0.642
70937540|NCT00696241|141374913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.672|TWO_SIDED|95.0|-2.05|1.32||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.32|-2.05|0.672
71063581|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-5.0|||||TWO_SIDED|95.0|-11.0|1.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||1|-11|
71063582|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-2.0|||||TWO_SIDED|95.0|-8.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||4|-8|
71063583|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-3.0|5.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%)||5|-3|
71063584|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-4.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||4|-4|
71063585|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-4.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||4|-4|
71078269|NCT01119846|141664790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99|||||TWO_SIDED|95.0|-1.91|-0.07|||||Comparison of iAUC 0-3|||-0.07|-1.91|
71078270|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|152.962|||||TWO_SIDED|95.0|-200.57|506.49|||||Comparison of C-peptide, AUC 0-2|||506.49|-200.57|
70937541|NCT00696241|141374913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.196|TWO_SIDED|95.0|-2.8|0.57||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.57|-2.80|0.196
71078271|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|113.866|||||TWO_SIDED|95.0|-252.69|480.42|||||Comparison of C-peptide, AUC 0-2|||480.42|-252.69|
70937542|NCT00696241|141374914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.48|||<|0.001|TWO_SIDED|95.0|2.71|7.39||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||7.39|2.71|<0.001
70937543|NCT00696241|141374914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.97|||<|0.001|TWO_SIDED|95.0|3.01|8.2||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||8.20|3.01|<0.001
71063586|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|-2.0|||||TWO_SIDED|95.0|-5.0|1.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||1|-5|
71063587|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|-1.0|||||TWO_SIDED|95.0|-4.0|2.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||2|-4|
71063588|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-2.0|3.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||3|-2|
71063589|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-8.0|1.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||1|-8|
71063590|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-4.0|||||TWO_SIDED|95.0|-9.0|0.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||0|-9|
71063591|NCT00450437|141636037|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-1.0|||||TWO_SIDED|95.0|-5.0|3.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||3|-5|
71078272|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|114.474|||||TWO_SIDED|95.0|-250.89|479.83|||||Comparison of C-peptide, AUC 0-2|||479.83|-250.89|
71078273|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|136.638|||||TWO_SIDED|95.0|-186.32|459.6|||||Comparison of C-peptide, AUC 0-2|||459.60|-186.32|
71078274|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|163.622|||||TWO_SIDED|95.0|-127.31|454.55|||||Comparison of C-peptide, iAUC 0-2|||454.55|-127.31|
71078275|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|58.074|||||TWO_SIDED|95.0|-243.57|359.72|||||Comparison of C-peptide, iAUC 0-2|||359.72|-243.57|
71078276|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|78.341|||||TWO_SIDED|95.0|-222.32|379.0|||||Comparison of C-peptide, iAUC 0-2|||379.00|-222.32|
71078277|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|157.044|||||TWO_SIDED|95.0|-108.73|422.82|||||Comparison of C-peptide, iAUC 0-2|||422.82|-108.73|
71078278|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.539|||||TWO_SIDED|95.0|-4.79|17.87|||||Comparison of GIP total, AUC 0-2|||17.87|-4.79|
71078279|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.095|||||TWO_SIDED|95.0|-7.65|15.84|||||Comparison of GIP total, AUC 0-2|||15.84|-7.65|
71078280|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.033|||||TWO_SIDED|95.0|1.33|24.74|||||Comparison of GIP total, AUC 0-2|||24.74|1.33|
71078281|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.824|||||TWO_SIDED|95.0|-13.17|7.52|||||Comparison of GIP total, AUC 0-2|||7.52|-13.17|
71063592|NCT00450437|141636038|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with seroresponse one month after vaccination is \> -10%.|Vaccine group difference|4.0|||||TWO_SIDED|95.0|0.0|8.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.||8|0|
71063593|NCT00450437|141636038|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with seroresponse one month after vaccination is \> -10%.|Vaccine group difference|5.0|||||TWO_SIDED|95.0|1.0|9.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenC.||9|1|
71063594|NCT00450437|141636038|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with seroresponse one month after vaccination is \> -10%.|Vaccine group difference|15.0|||||TWO_SIDED|95.0|11.0|20.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs.Licensed MenaCWY vaccine, MenW.||20|11|
71063595|NCT00450437|141636038|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with seroresponse one month after vaccination is \> -10%.|Vaccine group difference|23.0|||||TWO_SIDED|95.0|19.0|28.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.||28|19|
71063596|NCT00450437|141636038|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:8 one month after vaccination is \> -10%.|Vaccine group difference|4.0|||||TWO_SIDED|95.0|0.0|8.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.||8|0|
71063597|NCT00450437|141636038|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:8 one month after vaccination is \> -10%.|Vaccine group difference|3.0|||||TWO_SIDED|95.0|0.0|7.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenC.||7|0|
71111040|NCT00928187|141728114|SUPERIORITY_OR_OTHER|||||||0.13|||||||Chi-squared|||||||0.13
71111041|NCT01682356|141728120|SUPERIORITY|||||||0.0153|||||||t-test, 2 sided|Paired||||||0.0153
71063598|NCT00450437|141636038|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with with hSBA ≥ 1:8 one month after vaccination is \> -10%.|Vaccine group difference|6.0|||||TWO_SIDED|95.0|4.0|9.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenW.||9|4|
71111042|NCT01682356|141728121|SUPERIORITY|||||||0.0131|||||||t-test, 2 sided|Paired||||||0.0131
71111043|NCT01682356|141728122|SUPERIORITY|||||||0.83||||||P value adjusted for multiplicity|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.83
71111044|NCT01682356|141728123|SUPERIORITY||||||<|1e-07||||||P values adjusted for multiplicity. Exact P value 6.06 x 10\^-18.|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||<0.0000001
71063599|NCT00450437|141636038|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:8 one month after vaccination is \> -10%.|Vaccine group difference|15.0|||||TWO_SIDED|95.0|12.0|20.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.||20|12|
71063600|NCT00450437|141636038|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:4 one month after vaccination is \> -10%.|Vaccine group difference|3.0|||||TWO_SIDED|95.0|-1.0|7.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.||7|-1|
71111045|NCT01682356|141728124|SUPERIORITY||||||<|1e-07||||||P values adjusted for multiplicity. Exact P value 1.87 x 10\^-20.|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||<0.0000001
71111046|NCT01682356|141728125|SUPERIORITY||||||<|1e-07||||||P values adjusted for multiplicity. Exact P value 8.23 x 10\^-21.|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||<0.0000001
71111047|NCT01682356|141728126|SUPERIORITY|||||||0.6847||||||P values adjusted for multiplicity|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.6847
71111048|NCT01682356|141728127|SUPERIORITY|||||||0.6847||||||P values adjusted for multiplicity|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.6847
71111049|NCT01682356|141728128|SUPERIORITY|||||||0.4078||||||P values adjusted for multiplicity|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.4078
71111050|NCT01682356|141728129|SUPERIORITY|||||||0.4078||||||P values adjusted for multiplicity|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.4078
71063601|NCT00450437|141636038|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:4 one month after vaccination is \> -10%.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-1.0|4.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenC.||4|-1|
71063602|NCT00450437|141636038|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:4 one month after vaccination is \> -10%.|Vaccine group difference|6.0|||||TWO_SIDED|95.0|3.0|8.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenW.||8|3|
71063603|NCT00450437|141636038|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:4 one month after vaccination is \> -10%.|Vaccine group difference|12.0|||||TWO_SIDED|95.0|9.0|16.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.||16|9|
71078282|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.227|||||TWO_SIDED|95.0|-3.47|15.93|||||Comparison of GIP total, iAUC 0-2|||15.93|-3.47|
71078283|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.598|||||TWO_SIDED|95.0|-5.46|14.65|||||Comparison of GIP total, iAUC 0-2|||14.65|-5.46|
71078284|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.484|||||TWO_SIDED|95.0|-0.54|19.51|||||Comparison of GIP total, iAUC 0-2|||19.51|-0.54|
71078285|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.786|||||TWO_SIDED|95.0|-11.65|6.08|||||Comparison of GIP total, iAUC 0-2|||6.08|-11.65|
71078286|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.066|||||TWO_SIDED|95.0|-0.38|0.52|||||Comparison of GLP-1 active, AUC 0-2|||0.52|-0.38|
71078287|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.256|||||TWO_SIDED|95.0|-0.21|0.72|||||Comparison of GLP-1 active, AUC 0-2|||0.72|-0.21|
71078288|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|||||TWO_SIDED|95.0|-0.42|0.51|||||Comparison of GLP-1 active, AUC 0-2|||0.51|-0.42|
71078289|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.694|||||TWO_SIDED|95.0|2.28|3.11|||||Comparison of GLP-1 active, AUC 0-2|||3.11|2.28|
71078290|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.071|||||TWO_SIDED|95.0|-0.36|0.5|||||Comparison of GLP-1 active, iAUC 0-2|||0.50|-0.36|
71078291|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.243|||||TWO_SIDED|95.0|-0.2|0.69|||||Comparison of GLP-1 active, iAUC 0-2|||0.69|-0.20|
71078292|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|||||TWO_SIDED|95.0|-0.41|0.47|||||Comparison of GLP-1 active, iAUC 0-2|||0.47|-0.41|
71078293|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.643|||||TWO_SIDED|95.0|2.25|3.04|||||Comparison of GLP-1 active, iAUC 0-2|||3.04|2.25|
71078294|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.055|||||TWO_SIDED|95.0|-1.44|1.55|||||Comparison of GLP-1 total, AUC 0-2|||1.55|-1.44|
71078295|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.268|||||TWO_SIDED|95.0|-1.28|1.82|||||Comparison of GLP-1 total, AUC 0-2|||1.82|-1.28|
71078296|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.894|||||TWO_SIDED|95.0|-0.65|2.44|||||Comparison of GLP-1 total, AUC 0-2|||2.44|-0.65|
71078297|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.483|||||TWO_SIDED|95.0|-2.85|-0.12|||||Comparison of GLP-1 total, AUC 0-2|||-0.12|-2.85|
71078298|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|||||TWO_SIDED|95.0|-1.18|1.34|||||Comparison of GLP-1 total, iAUC 0-2|||1.34|-1.18|
71078299|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.331|||||TWO_SIDED|95.0|-0.97|1.63|||||Comparison of GLP-1 total, iAUC 0-2|||1.63|-0.97|
71078300|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.177|||||TWO_SIDED|95.0|-1.48|1.12|||||Comparison of GLP-1 total, iAUC 0-2|||1.12|-1.48|
71078301|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.19|||||TWO_SIDED|95.0|-2.34|-0.04|||||Comparison of GLP-1 total, iAUC 0-2|||-0.04|-2.34|
71078302|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.235|||||TWO_SIDED|95.0|-1.51|3.98|||||Comparison of Glucagon, AUC 0-2|||3.98|-1.51|
71078303|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.877|||||TWO_SIDED|95.0|0.04|5.71|||||Comparison of Glucagon, AUC 0-2|||5.71|0.04|
71078304|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.473|||||TWO_SIDED|95.0|-1.21|4.16|||||Comparison of Glucagon, AUC 0-2|||4.16|-1.21|
71078305|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.274|||||TWO_SIDED|95.0|-2.2|2.74|||||Comparison of Glucagon, AUC 0-2|||2.74|-2.20|
71078306|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.177|||||TWO_SIDED|95.0|-4.92|0.56|||||Comparison of Glucagon, iAUC 0-2|||0.56|-4.92|
71078307|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.909|||||TWO_SIDED|95.0|-4.74|0.93|||||Comparison of Glucagon, iAUC 0-2|||0.93|-4.74|
71078308|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.053|||||TWO_SIDED|95.0|-3.74|1.63|||||Comparison of Glucagon, iAUC 0-2|||1.63|-3.74|
71078309|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.249|||||TWO_SIDED|95.0|-3.72|1.22|||||Comparison of Glucagon, iAUC 0-2|||1.22|-3.72|
71078310|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.389|||||TWO_SIDED|95.0|-95.82|122.59|||||Comparison of Insulin, AUC 0-3|||122.59|-95.82|
71078311|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.98|||||TWO_SIDED|95.0|-103.25|123.21|||||Comparison of Insulin, AUC 0-3|||123.21|-103.25|
71078312|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.426|||||TWO_SIDED|95.0|-80.43|145.28|||||Comparison of Insulin, AUC 0-3|||145.28|-80.43|
71078313|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.994|||||TWO_SIDED|95.0|-76.77|122.76|||||Comparison of Insulin, AUC 0-3|||122.76|-76.77|
71078314|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.088|||||TWO_SIDED|95.0|-86.79|90.97|||||Comparison of Insulin, iAUC 0-3|||90.97|-86.79|
71078315|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.316|||||TWO_SIDED|95.0|-92.47|91.84|||||Comparison of Insulin, iAUC 0-3|||91.84|-92.47|
71063604|NCT00450437|141636039|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence lower limit was 0.5. If the lower limit of two sided 95% CIs for the ratio of the hSBA GMT (GMT for investigational vaccine / GMT for licensed vaccine) at one month following vaccination was above this limit, Investigational MenACWY vaccine would be non-inferior to Licensed MenACWY vaccine for Neisseria Meningitidis strain A with respect to the immune response.|hSBA GMT ratios|1.32|||||TWO_SIDED|95.0|1.12|1.56|||ANOVA|||"Non-inferiority of Investigational MenACWY Vaccine vs. Licensed MenACWY vaccine, MenA.~The study would be considered a success if the lower limit of the two-sided 95% CIs for the hSBA GMT ratios comparing Investigational MenACWY vaccine to Licensed MenACWY vaccine for Neisseria Meningitidis strain A at 1 month after vaccination was to be above 0.5."||1.56|1.12|
71063605|NCT00450437|141636039|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence lower limit was 0.5. If the lower limit of two sided 95% CIs for the ratio of the hSBA GMT (GMT for investigational vaccine / GMT for licensed vaccine) at one month following vaccination was above this limit, Investigational MenACWY vaccine would be non-inferior to Licensed MenACWY vaccine for Neisseria Meningitidis strain C with respect to the immune response.|hSBA GMT ratios|1.4|||||TWO_SIDED|95.0|1.17|1.67|||ANOVA|||"Non-inferiority of Investigation MenACWY vaccine vs. Licensed MenACWY vaccine, MenC.~The study would be considered a success if the lower limit of the two-sided 95% CIs for the hSBA GMT ratios comparing Investigational MenACWY vaccine to Licensed MenACWY vaccine for Neisseria Meningitidis strain C at 1 month after vaccination was to be above 0.5."||1.67|1.17|
71063606|NCT00450437|141636039|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence lower limit was 0.5. If the lower limit of two sided 95% CIs for the ratio of the hSBA GMT (GMT for investigational vaccine / GMT for licensed vaccine) at one month following vaccination was above this limit, Investigational MenACWY vaccine would be non-inferior to Licensed MenACWY vaccine for Neisseria Meningitidis strain W with respect to the immune response.|hSBA GMT ratios|1.76|||||TWO_SIDED|95.0|1.51|2.05|||ANOVA|||"Non-inferiority of Investigational MenACWY vaccine vs. Licensed MenACWY vaccine, MenW.~The study would be considered a success if the lower limit of the two-sided 95% CIs for the hSBA GMT ratios comparing Investigational MenACWY vaccine to Licensed MenACWY vaccine for Neisseria Meningitidis strain W at 1 month after vaccination was to be above 0.5."||2.05|1.51|
71063607|NCT00450437|141636039|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence lower limit was 0.5. If the lower limit of two sided 95% CIs for the ratio of the hSBA GMT (GMT for investigational vaccine / GMT for licensed vaccine) at one month following vaccination was above this limit, Investigational MenACWY vaccine would be non-inferior to Licensed MenACWY vaccine for Neisseria Meningitidis strain Y with respect to the immune response.|hSBA GMT ratios|2.49|||||TWO_SIDED|95.0|2.11|2.95|||ANOVA|||"Non-inferiority of Investigational MenACWY Vaccine vs. Licensed MenACWY vaccine, MenY.~The study would be considered a success if the lower limit of the two-sided 95% CIs for the hSBA GMT ratios comparing Investigational MenACWY vaccine to Licensed MenACWY vaccine for Neisseria Meningitidis strain Y at 1 month after vaccination was to be above 0.5."||2.95|2.11|
71063608|NCT00450437|141636041|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|-1.0|||||TWO_SIDED|95.0|-7.0|5.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.||5|-7|
71063609|NCT00450437|141636041|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|9.0|||||TWO_SIDED|95.0|3.0|15.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine. MenC.||15|3|
71063610|NCT00450437|141636041|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|9.0|||||TWO_SIDED|95.0|2.0|17.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenW.||17|2|
71063611|NCT00450437|141636041|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|16.0|||||TWO_SIDED|95.0|9.0|23.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.||23|9|
71063612|NCT03907488|141636042|SUPERIORITY||||||<|0.005||||||One sided P-value|Log Rank|||The primary analysis of PFS used a stratified log rank test statistic and is reported as two-sided test. Stratified Cox regression was used to estimate treatment hazard ratios for treatment effect. 95% two-sided intervals are reported. The Kaplan-Meier method was used to estimate PFS curves.||||<0.005
71063613|NCT01766076|141636052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.0|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Mann Whitney test was used for nonparametric variables||||||<0.05
71063614|NCT01611883|141636079|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Ezetimibe treatment group will be considered non-inferior to the placebo control group if the upper bound of the two-sided 95% confidence interval (CI) of the between-treatment difference (ezetimibe minus placebo) in means for change in HbA1c from baseline to the end of treatment does not exceed 0.5%.|Difference in Least-squares Means|0.08|||||TWO_SIDED|95.0|-0.07|0.23|||Longitudinal analysis of covariance|"Treatment group, HbA1c level, insulin use, time, and time × treatment group interaction as factors, and baseline as covariate"|ezetimibe minus placebo|||0.23|-0.07|
70941756|NCT04748445|141383935|OTHER||Slope|-0.0001473|STANDARD_ERROR_OF_MEAN|5.891||0.8029|TWO_SIDED|90.0|-0.001123|0.0008288|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0008288|-0.001123|0.8029
70937544|NCT00696241|141374914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.53|||<|0.001|TWO_SIDED|95.0|3.95|10.79||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||10.79|3.95|<0.001
71063615|NCT01611883|141636080|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|0.0|||||TWO_SIDED|95.0|-0.47|0.47|||Longitudinal analysis of covariance||ezetimibe minus placebo|||0.47|-0.47|
71063616|NCT01611883|141636081|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-4.8|||||TWO_SIDED|95.0|-12.1|2.5|||Longitudinal Analysis of Covariance||ezetimibe minus placebo|||2.5|-12.1|
71063617|NCT01611883|141636082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.779|||||||Fisher Exact|||Comparison of percentage difference between ezetimibe and placebo||||0.779
71063618|NCT01611883|141636083|SUPERIORITY_OR_OTHER_LEGACY|||||||0.365|||||||Fisher Exact|||Comparison of percentage difference between ezetimibe and placebo||||0.365
71063619|NCT01611883|141636084|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-21.05|||<|0.001|TWO_SIDED|95.0|-25.06|-17.03|||Longitudinal analysis of covariance|"Treatment group, HbA1c level, insulin use, time, and time × treatment group interaction as factors, and baseline as covariate"|ezetimibe minus placebo|||-17.03|-25.06|<0.001
71063620|NCT01611883|141636085|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-13.54|||<|0.001|TWO_SIDED|95.0|-16.66|-10.42|||Longitudinal analysis of covariance|"Treatment group, HbA1c level, insulin use, time, and time × treatment group interaction as factors, and baseline as covariate"|ezetimibe minus placebo|||-10.42|-16.66|<0.001
71063621|NCT01611883|141636086|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-11.36||||0.025|TWO_SIDED|95.0|-21.27|-1.44|||Longitudinal Analysis of Covariance|"Treatment group, HbA1c level, insulin use, time, and time × treatment group interaction as factors, and baseline as covariate"|ezetimibe minus placebo|||-1.44|-21.27|0.025
71063622|NCT01611883|141636087|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|2.45||||0.246|TWO_SIDED|95.0|-1.71|6.61|||Longitudinal Analysis of Covariance|"Treatment group, HbA1c level, insulin use, time, and time × treatment group interaction as factors, and baseline as covariate"|ezetimibe minus placebo|||6.61|-1.71|0.246
71063623|NCT01611883|141636088|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-19.07|||<|0.001|TWO_SIDED|95.0|-22.71|-15.43|||Longitudinal Analysis of Covariance|"Treatment group, HbA1c level, insulin use, time, and time × treatment group interaction as factors, and baseline as covariate"|ezetimibe minus placebo|||-15.43|-22.71|<0.001
71063624|NCT05142722|141636108|SUPERIORITY||Least Squares (LS) Means|-32.65|STANDARD_ERROR_OF_MEAN|1.602|<|0.0001|TWO_SIDED|95.0|-35.79|-29.5|||ANCOVA|||||-29.50|-35.79|<.0001
71063625|NCT05142722|141636109|SUPERIORITY||Least Squares (LS) Means|-33.78|STANDARD_ERROR_OF_MEAN|1.678|<|0.0001|TWO_SIDED|95.0|-37.07|-30.49|||ANCOVA|||||-30.49|-37.07|<.0001
71063626|NCT05142722|141636110|SUPERIORITY||Least Squares (LS) Means|-23.98|STANDARD_ERROR_OF_MEAN|1.979|<|0.0001|TWO_SIDED|95.0|-27.87|-20.09||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-20.09|-27.87|<.0001
71063627|NCT05142722|141636111|SUPERIORITY||Least Squares (LS) Means|-18.92|STANDARD_ERROR_OF_MEAN|0.936|<|0.0001|TWO_SIDED|95.0|-20.76|-17.09||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-17.09|-20.76|<.0001
71063628|NCT05142722|141636112|SUPERIORITY||Least Squares (LS) Means|-18.31|STANDARD_ERROR_OF_MEAN|1.057|<|0.0001|TWO_SIDED|95.0|-20.38|-16.23||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-16.23|-20.38|<.0001
71063629|NCT05142722|141636113|SUPERIORITY||Least Squares (LS) Means|-13.8|STANDARD_ERROR_OF_MEAN|1.219|<|0.0001|TWO_SIDED|95.0|-16.2|-11.41||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-11.41|-16.20|<.0001
71063630|NCT05142722|141636114|SUPERIORITY||Least Squares (LS) Means|-29.44|STANDARD_ERROR_OF_MEAN|1.251|<|0.0001|TWO_SIDED|95.0|-31.89|-26.99||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-26.99|-31.89|<.0001
71063631|NCT05142722|141636115|SUPERIORITY||Least Squares (LS) Means|-28.32|STANDARD_ERROR_OF_MEAN|1.339|<|0.0001|TWO_SIDED|95.0|-30.94|-25.69||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-25.69|-30.94|<.0001
71063632|NCT05142722|141636116|SUPERIORITY||Least Squares (LS) Means|-23.02|STANDARD_ERROR_OF_MEAN|1.564|<|0.0001|TWO_SIDED|95.0|-26.09|-19.95||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-19.95|-26.09|<.0001
71063633|NCT05142722|141636117|SUPERIORITY||Least Squares (LS) Means|136.26|STANDARD_ERROR_OF_MEAN|1.939|<|0.0001|TWO_SIDED|95.0|132.46|140.07||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||140.07|132.46|<.0001
71063634|NCT05142722|141636118|SUPERIORITY||Least Squares (LS) Means|134.43|STANDARD_ERROR_OF_MEAN|2.343|<|0.0001|TWO_SIDED|95.0|129.84|139.03||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||139.03|129.84|<.0001
71063635|NCT05142722|141636119|SUPERIORITY||Least Squares (LS) Means|122.04|STANDARD_ERROR_OF_MEAN|2.299|<|0.0001|TWO_SIDED|95.0|117.53|126.55||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||126.55|117.53|<.0001
71063636|NCT05142722|141636120|SUPERIORITY||Least Squares (LS) Means|-14.12|STANDARD_ERROR_OF_MEAN|20.183||0.4841|TWO_SIDED|95.0|-53.68|25.44||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05; therefore hierarchical testing was stopped for subsequent secondary endpoints|ANCOVA|||||25.44|-53.68|0.4841
71063637|NCT04846569|141636167|SUPERIORITY||Mean Difference (Final Values)|0.004|||||TWO_SIDED|95.0|-0.38|0.39||||||||0.39|-0.38|
71063638|NCT04846569|141636168|SUPERIORITY||Mean Difference (Final Values)|-0.15|||||TWO_SIDED|95.0|-0.78|0.47||||||||0.47|-0.78|
71063639|NCT04846569|141636169|SUPERIORITY|||||||||||||||||All participants who we were able to obtain records for were virally suppressed thus an effect size was unable to be calculated.|All participants who we were able to obtain records for were virally suppressed thus an effect size was unable to be calculated as originally planned.|||
71063640|NCT04846569|141636170|SUPERIORITY||Median Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.2|0.53||||||||0.53|-0.20|
71063641|NCT04846569|141636171|OTHER|Qualitative data analysis|||||||||||||||||Thematic qualitative data analysis was conducted to determine the count of participants reporting positively about the intervention|||
71063642|NCT01467713|141636172|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.286|TWO_SIDED|98.3|0.42|1.39|||Log Rank||Cox proportional hazards model with only treatment in the model.|||1.39|0.42|0.286
71063643|NCT01467713|141636172|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.332|TWO_SIDED|98.3|0.43|1.43|||Log Rank||Cox proportional hazards model with only treatment in the model.|||1.43|0.43|0.332
71111051|NCT01682356|141728130|SUPERIORITY|||||||0.3042||||||P value adjusted for multiplicity|ANOVA|Breath nitric oxide values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.3042
71063644|NCT01467713|141636172|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.808|TWO_SIDED|98.3|0.6|1.86|||Log Rank||Cox proportional hazards model with only treatment in the model.|||1.86|0.60|0.808
71063645|NCT01467713|141636172|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.286|TWO_SIDED|98.3|0.48|1.61|||Log Rank||Cox proportional hazards model with treatment, pooled center, age, gender, and baseline MADRS score in the model.|||1.61|0.48|0.286
71063646|NCT01467713|141636172|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.332|TWO_SIDED|98.3|0.42|1.49|||Log Rank||Cox proportional hazards model with treatment, pooled center, age, gender, and baseline MADRS score in the model.|||1.49|0.42|0.332
71063647|NCT01467713|141636172|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.808|TWO_SIDED|98.3|0.6|1.95|||Log Rank||Cox proportional hazards model with treatment, pooled center, age, gender, and baseline MADRS score in the model.|||1.95|0.60|0.808
71063648|NCT00607620|141636222|SUPERIORITY||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.79|0.98||||||||0.98|0.79|
71063649|NCT00607620|141636223|SUPERIORITY||Mean Difference (Net)|-1.2|||||TWO_SIDED|95.0|-2.1|-0.3|||||The data represented refers to the group mean difference (intervention versus control) of the change score between baseline to 12-months.|||-0.3|-2.1|
71063650|NCT00607620|141636224|SUPERIORITY||Mean Difference (Net)|3.4|||||TWO_SIDED|95.0|0.4|6.4|||||The data represented refers to the group mean difference (intervention versus control) of the change score between 6-months and 12-months.|||6.4|0.4|
71063651|NCT00607620|141636225|SUPERIORITY||Mean Difference (Net)|-0.7|||||TWO_SIDED|95.0|-3.3|1.9|||||The data represented refers to the group mean difference (intervention versus control) of the change score between 6-months and 12-months.|||1.9|-3.3|
71063652|NCT00607620|141636226|SUPERIORITY||Mean Difference (Net)|-0.01|||||TWO_SIDED|95.0|-1.02|0.99|||||The data represented refers to the group mean difference (intervention versus control) of the change score between 6-months and 12-months.|||0.99|-1.02|
71063653|NCT01620138|141636227|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71063654|NCT03175536|141636274|SUPERIORITY||Mean Difference (Net)|3.4||||0.05|TWO_SIDED|95.0|-5.2|12.1|||GEE models|Negative binomial regression with GEE model; term of interest was interaction between study group and time period (baseline vs follow-up year).|Using terms from the regression model, we applied marginal effects methods to calculate mean adjusted baseline and follow-up PDC and absolute changes|||12.1|-5.2|0.05
71063655|NCT03175536|141636275|SUPERIORITY||Mean Difference (Net)|1.3||||0.05|TWO_SIDED|95.0|-4.4|7.0|||GEE model|Negative binomial regression with GEE model; term of interest was interaction between study group and time period (baseline vs follow-up year).|Using terms from the regression model, we applied marginal effects methods to calculate mean adjusted baseline and follow-up PDC and absolute changes|||7.0|-4.4|0.05
71063656|NCT03175536|141636276|SUPERIORITY||Mean Difference (Net)|6.0||||0.05|TWO_SIDED|95.0|0.7|11.3|||GEE model|Binomial regression with GEE model; term of interest was interaction between study group and time period (baseline vs follow-up year).|Using terms from the regression model, we applied marginal effects methods to calculate mean adjusted baseline and follow-up PDC and absolute changes.|||11.3|0.7|0.05
71063657|NCT03175536|141636277|SUPERIORITY||Mean Difference (Net)|0.16||||0.05|TWO_SIDED|95.0|-0.74|1.06|||GEE model|Negative binomial regression with GEE model; term of interest was interaction between study group and time period (baseline vs follow-up year).|Using terms from the regression model, we applied marginal effects methods to calculate mean adjusted baseline and follow-up PDC and absolute changes|||1.06|-0.74|0.05
71111052|NCT01682356|141728131|SUPERIORITY||||||<|1e-07||||||P value adjusted for multiplicity. Exact P value 3.469 x 10\^-7.|ANOVA|Breath nitric oxide values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||<0.0000001
71111053|NCT01682356|141728132|SUPERIORITY||||||<|1e-07||||||P value adjusted for multiplicity. Exact P value 7.202 x 10\^-8|ANOVA|Breath nitric oxide values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||<0.0000001
71063658|NCT03175536|141636278|SUPERIORITY||Median Difference (Net)|-34.0||||0.05|TWO_SIDED|95.0|-47.0|-21.0|||GEE model|Negative binomial regression with GEE model; term of interest was interaction between study group and time period (baseline vs follow-up year).|Using terms from the regression model, we applied marginal effects methods to calculate mean adjusted baseline and follow-up PDC and absolute changes.|||-21|-47|0.05
71063659|NCT01100086|141636292|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|102.0|||||TWO_SIDED|90.0|99.35|105.42|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||105.42|99.35|
71063660|NCT01100086|141636293|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|98.0|||||TWO_SIDED|90.0|94.94|101.19|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||101.19|94.94|
71063661|NCT01100086|141636294|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|98.3|||||TWO_SIDED|90.0|95.2|101.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||101.48|95.20|
71063662|NCT01100086|141636294|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|98.3|||||TWO_SIDED|90.0|95.2|101.48|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||101.48|95.20|
71063663|NCT02954601|141636311|OTHER|Values obtained using a Mixed Model Repeated Measures Analysis of Variance with an unstructured covariance matrix. Treatment, Period and Baseline value (for change and percent change) are factors in the model with repeated values for a subject.||||||0.1311|||||||Mixed Models Analysis|||||||0.1311
71063664|NCT02954601|141636314|OTHER|||||||0.3061|TWO_SIDED|95.0|||||Mixed Models Analysis|||Values obtained using a Mixed Model Repeated Measures Analysis of Variance with an unstructured covariance matrix. Treatment period and Baseline value (for change and percent change) are factors in the model with repeated values for subject.||||0.3061
71063665|NCT00333983|141636315|SUPERIORITY_OR_OTHER|||||||0.025||||||P value was set at .025 to adjust for 2 treatment comparisons and for interim monitoring for the treatment effect.|Mixed Models Analysis|||An analysis of all robot interventions compared with intensive conventional exercise for Fugl-Meyer change were completed using linear mixed models.||||.025
71063666|NCT00833105|141636316|SUPERIORITY_OR_OTHER||||||<|0.025|TWO_SIDED||||||Mixed Models Analysis|Random subject effect||||||<0.025
71063667|NCT00833105|141636317|SUPERIORITY_OR_OTHER|||||||0.299|TWO_SIDED||||||Mixed Models Analysis|Random subject effect||||||0.299
71063668|NCT00833105|141636318|SUPERIORITY_OR_OTHER|||||||0.459|TWO_SIDED||||||Mixed Models Analysis|Random subject effect||||||0.459
71063669|NCT00833105|141636319|SUPERIORITY_OR_OTHER|||||||0.343|TWO_SIDED||||||Mixed Models Analysis|Random subject effect||||||0.343
71063670|NCT00833105|141636320|SUPERIORITY_OR_OTHER|||||||0.951|TWO_SIDED||||||Mixed Models Analysis|Random subject effects||||||0.951
71063671|NCT00833105|141636321|SUPERIORITY_OR_OTHER|||||||0.371|TWO_SIDED||||||Mixed Models Analysis|Random subject effect||||||0.371
71063672|NCT00833105|141636322|SUPERIORITY_OR_OTHER|||||||0.164|TWO_SIDED||||||Mixed Models Analysis|Random subject effect||||||0.164
71063673|NCT00833105|141636323|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon Signed-Rank|No multiple comparison procedure||Pre-training score is average of a total of 9 efforts, including 3 efforts from the first 3 days of training. Post-training score is average of a total of 9 efforts, including 3 efforts from the last 3 days of training.||||<0.01
71063674|NCT00833105|141636324|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||No multiple comparison procedure performed|Wilcoxon Signed Rank Test|||||||<0.05
71063675|NCT00833105|141636325|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||No multiple comparison procedure|Wilcoxon Signed Rank Test|||||||<0.0001
71063676|NCT00833105|141636326|SUPERIORITY_OR_OTHER||||||<|0.005|TWO_SIDED|||||No multiple comparison adjustment.|Wilcoxon Signed Rank Test|||||||<0.005
71063677|NCT00833105|141636327|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||No multiple comparison adjustment.|Wilcoxon Signed Rank Test|||||||<0.001
71063678|NCT00833105|141636328|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||No multiple comparisons adjustment.|Wilcoxon Signed Rank Test|||||||<0.001
71063679|NCT03982511|141636445|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.73|TWO_SIDED|||||Given that this is a pilot RCT, primary aim is to estimate effect sizes for a more fully-powered RCT. P-values will be provided in addition to effect size.|ANOVA|Repeated measures|Effect size: 0.17|Difference on difference from T2 to T1 for BMI z-score||||.73
71063680|NCT03982511|141636445|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.18||0.98|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for BMI z-score from T3 to T1|Effect size: -0.01|||.98
71078316|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.053|||||TWO_SIDED|95.0|-71.8|111.91|||||Comparison of Insulin, iAUC 0-3|||111.91|-71.80|
71078317|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.606|||||TWO_SIDED|95.0|-57.59|104.8|||||Comparison of Insulin, iAUC 0-3|||104.80|-57.59|
71078318|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.506|||||TWO_SIDED|95.0|-3.13|10.14|||||Comparison of PYY total, AUC 0-2|||10.14|-3.13|
71078319|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.295|||||TWO_SIDED|95.0|0.41|14.18|||||Comparison of PYY total, AUC 0-2|||14.18|0.41|
71078320|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.006|||||TWO_SIDED|95.0|0.15|13.87|||||Comparison of PYY total, AUC 0-2|||13.87|0.15|
71078321|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.555|||||TWO_SIDED|95.0|-8.62|3.51|||||Comparison of PYY total, AUC 0-2|||3.51|-8.62|
70937545|NCT00696241|141374914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.173|TWO_SIDED|95.0|0.57|1.11||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.11|0.57|0.173
70937546|NCT00696241|141374914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.449|TWO_SIDED|95.0|0.63|1.23||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.23|0.63|0.449
70937547|NCT00696241|141374914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.402|TWO_SIDED|95.0|0.83|1.62||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.62|0.83|0.402
70937548|NCT00696241|141374915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.86|||<|0.001|TWO_SIDED|95.0|1.82|4.48||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||4.48|1.82|<0.001
71063681|NCT03982511|141636445|SUPERIORITY||Mean Difference (Net)|1.93|STANDARD_ERROR_OF_MEAN|3.97||0.63|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for BMI percentile from T2 to T1|Effect size: 0.24|||0.63
71063682|NCT03982511|141636445|SUPERIORITY||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|4.51||0.96|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for BMI percentile from T3 to T1|Effect size: 0.03|||0.96
70937549|NCT00696241|141374915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.39|||<|0.001|TWO_SIDED|95.0|2.15|5.35||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||5.35|2.15|<0.001
70937550|NCT00696241|141374915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.81|||<|0.001|TWO_SIDED|95.0|2.41|6.02||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||6.02|2.41|<0.001
70937551|NCT00696241|141374915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.177|TWO_SIDED|95.0|0.52|1.13||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.13|0.52|0.177
70937552|NCT00696241|141374915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.628|TWO_SIDED|95.0|0.61|1.35||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.35|0.61|0.628
71063683|NCT03982511|141636446|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.12||0.12|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for Emotion regulation subscale from T2 to T1|Effect size: 0.79|||0.12
71063684|NCT03982511|141636446|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.14||0.96|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for emotion regulation subscale from T3 to T1|Effect size: -0.02|||0.96
71063685|NCT03982511|141636447|SUPERIORITY||Mean Difference (Net)|-6.08|STANDARD_ERROR_OF_MEAN|5.42||0.28|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for child weekly screen time from T2 to T1|Effect size: -0.41|||0.28
71063686|NCT03982511|141636447|SUPERIORITY||Mean Difference (Net)|5.83|STANDARD_ERROR_OF_MEAN|7.17||0.43|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for child weekly screen time from T3 to T1|Effect size: 0.42|||0.43
71078322|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.523|||||TWO_SIDED|95.0|-2.13|7.17|||||Comparison of PYY total, iAUC 0-2|||7.17|-2.13|
71078323|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.296|||||TWO_SIDED|95.0|0.47|10.12|||||Comparison of PYY total, iAUC 0-2|||10.12|0.47|
71078324|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.726|||||TWO_SIDED|95.0|-3.08|6.53|||||Comparison of PYY total, iAUC 0-2|||6.53|-3.08|
71078325|NCT01119846|141664791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.506|||||TWO_SIDED|95.0|-7.75|0.74|||||Comparison of PYY total, iAUC 0-2|||0.74|-7.75|
71078326|NCT01119846|141664792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.241|||||TWO_SIDED|95.0|-0.84|1.32||||||||1.32|-0.84|
71078327|NCT01119846|141664792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.523|||||TWO_SIDED|95.0|-0.6|1.64||||||||1.64|-0.60|
71078328|NCT01119846|141664792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.053|||||TWO_SIDED|95.0|-1.17|1.06||||||||1.06|-1.17|
70937553|NCT00696241|141374915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.928|TWO_SIDED|95.0|0.68|1.52||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.52|0.68|0.928
71063687|NCT03982511|141636448|SUPERIORITY||Mean Difference (Net)|35.32|STANDARD_ERROR_OF_MEAN|23.86||0.16|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference score for MVPA minutes from T2 to T1|Effect size: 0.85|||0.16
71063688|NCT03982511|141636448|SUPERIORITY|Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|Mean Difference (Net)|16.09|STANDARD_ERROR_OF_MEAN|30.32||0.61|TWO_SIDED||||||ANOVA|Repeated measures||Difference on difference score for MVPA minutes from T3 to T1|Effect size: 0.35|||0.61
71063689|NCT03982511|141636448|SUPERIORITY||Mean Difference (Net)|-64.4|STANDARD_ERROR_OF_MEAN|54.5||0.26|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference score for sedentary minutes from T2 to T1|Effect size: -0.68|||0.26
71063690|NCT03982511|141636448|SUPERIORITY||Mean Difference (Net)|66.25|STANDARD_ERROR_OF_MEAN|66.43||0.34|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference score for sedentary minutes from T3 to T1|effect size: 0.66|||0.34
71063691|NCT03982511|141636449|SUPERIORITY||Mean Difference (Net)|-0.64|STANDARD_ERROR_OF_MEAN|0.75||0.41|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for parent-reported sleep time from T2 to T1|effect size: -0.41|||0.41
71063692|NCT03982511|141636449|SUPERIORITY||Mean Difference (Net)|1.39|STANDARD_ERROR_OF_MEAN|0.95||0.16|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for parent-reported sleep time from T3 to T1|effect size: 0.76|||0.16
71063693|NCT03982511|141636450|SUPERIORITY||Mean Difference (Net)|-12.62|STANDARD_ERROR_OF_MEAN|14.84||0.42|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for actigraphy-recorded sleep time from T2 to T1|effect size: -0.54|||0.42
71063694|NCT03982511|141636450|SUPERIORITY||Mean Difference (Net)|-38.83|STANDARD_ERROR_OF_MEAN|16.61||0.04|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for actigraphy-recorded sleep time from T3 to T1|effect size: -1.56|||0.04
71063695|NCT03982511|141636451|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.26||0.77|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for problematic media use from T2 to T1|effect size: 0.15|||0.77
71063696|NCT03982511|141636451|SUPERIORITY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.28||0.47|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for problematic media use from T3 to T1|effect size: -0.38|||0.47
71078329|NCT01119846|141664792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|||||TWO_SIDED|95.0|-0.81|1.16||||||||1.16|-0.81|
71078330|NCT01119846|141664793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.08|0.06|||||Comparison of G/I ratio|||0.06|-0.08|
71078331|NCT01119846|141664793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|||||TWO_SIDED|95.0|-0.07|0.07|||||Comparison of G/I ratio|||0.07|-0.07|
71078332|NCT01119846|141664793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|||||TWO_SIDED|95.0|-0.07|0.07|||||Comparison of G/I ratio|||0.07|-0.07|
71078333|NCT01119846|141664793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.017|||||TWO_SIDED|95.0|-0.04|0.08|||||Comparison of G/I ratio|||0.08|-0.04|
71078334|NCT01119846|141664793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.269|||||TWO_SIDED|95.0|-8.31|12.85|||||Comparison of I/G ratio|||12.85|-8.31|
71078335|NCT01119846|141664793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.959|||||TWO_SIDED|95.0|-8.01|13.93|||||Comparison of I/G ratio|||13.93|-8.01|
71078336|NCT01119846|141664793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.053|||||TWO_SIDED|95.0|-4.88|16.99|||||Comparison of I/G ratio|||16.99|-4.88|
71078337|NCT01119846|141664793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.017|||||TWO_SIDED|95.0|-5.65|13.68|||||Comparison of I/G ratio|||13.68|-5.65|
71078338|NCT01119846|141664794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025|||||TWO_SIDED|95.0|-0.28|0.22|||||Comparison of insulin glucose index|||0.22|-0.28|
71078339|NCT01119846|141664794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.055|||||TWO_SIDED|95.0|-0.2|0.31|||||Comparison of insulin glucose index|||0.31|-0.20|
71078340|NCT01119846|141664794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.028|||||TWO_SIDED|95.0|-0.29|0.23|||||Comparison of insulin glucose index|||0.23|-0.29|
71078341|NCT01119846|141664794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.041|||||TWO_SIDED|95.0|-0.27|0.19|||||Comparison of insulin glucose index|||0.19|-0.27|
71078342|NCT01119846|141664795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.346|||||TWO_SIDED|95.0|-2.06|1.37||||||||1.37|-2.06|
71078343|NCT01119846|141664795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|||||TWO_SIDED|95.0|-1.82|1.73||||||||1.73|-1.82|
71078344|NCT01119846|141664795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.388|||||TWO_SIDED|95.0|-2.16|1.38||||||||1.38|-2.16|
71078345|NCT01119846|141664795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.133|||||TWO_SIDED|95.0|-1.43|1.7||||||||1.70|-1.43|
71078346|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.523|||||TWO_SIDED|95.0|-3.04|2.0|||||Comparison of Day 7, 1 Hour|||2.00|-3.04|
71078347|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.569|||||TWO_SIDED|95.0|-3.07|1.94|||||Comparison of Day 7, 1 Hour|||1.94|-3.07|
70937554|NCT00696241|141374916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.53|||<|0.001|TWO_SIDED|95.0|2.66|7.72||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||7.72|2.66|<0.001
70937555|NCT00696241|141374916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.04|||<|0.001|TWO_SIDED|95.0|2.96|8.58||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||8.58|2.96|<0.001
70937556|NCT00696241|141374916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.75|||<|0.001|TWO_SIDED|95.0|3.96|11.48||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||11.48|3.96|<0.001
70937557|NCT00696241|141374916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.217|TWO_SIDED|95.0|0.58|1.13||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.13|0.58|0.217
70937558|NCT00696241|141374916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.537|TWO_SIDED|95.0|0.64|1.26||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.26|0.64|0.537
70937559|NCT00696241|141374916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.276|TWO_SIDED|95.0|0.86|1.68||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.68|0.86|0.276
70937560|NCT01742832|141374917|OTHER|Linear repeated measures regression models were constructed to assess trends over time between groups where the dependent variable was outcome measure (MADRS score) and independent variables included visit, treatment group, visit by treatment group interaction, and any baseline variables that were significant between groups.||||||0.342||||||P-value for linear regression assessing outcome measure (MADRS score) and treatment group.|Regression, Linear|||||||0.342
71078348|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.064|||||TWO_SIDED|95.0|-0.45|4.57|||||Comparison of Day 7, 1 Hour|||4.57|-0.45|
70941757|NCT04748445|141383935|OTHER||Slope|-0.0005556|STANDARD_ERROR_OF_MEAN|4.647||0.2342|TWO_SIDED|90.0|-0.001326|0.0002146|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 07 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0002146|-0.001326|0.2342
71063697|NCT03982511|141636452|SUPERIORITY||Mean Difference (Net)|9.11|STANDARD_ERROR_OF_MEAN|2.76||0.005|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for child-centered skills from T2 to T1|effect size: 1.65|||0.005
71063698|NCT03982511|141636452|SUPERIORITY||Mean Difference (Net)|8.22|STANDARD_ERROR_OF_MEAN|3.81||0.05|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for child-centered skills from T3 to T1|effect size: 1.20|||0.05
71063699|NCT03982511|141636453|SUPERIORITY||Mean Difference (Net)|-17.23|STANDARD_ERROR_OF_MEAN|6.93||0.02|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for PCDI scores from T2 to T1.|effect size: -1.21|||0.02
71063700|NCT03982511|141636453|SUPERIORITY||Mean Difference (Net)|-19.43|STANDARD_ERROR_OF_MEAN|6.4||0.008|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for PCDI scores from T3 to T1|effect size: -1.57|||0.008
71063701|NCT03982511|141636454|SUPERIORITY||Mean Difference (Net)|-0.25|STANDARD_ERROR_OF_MEAN|0.36||0.5|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for pressure to eat scores from T2 to T1|effect size: -0.34|||0.50
71063702|NCT03982511|141636454|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.37||0.98|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for pressure to eat scores from T3 to T1|effect size: -0.01|||0.98
71063703|NCT03982511|141636455|SUPERIORITY||Mean Difference (Net)|-0.46|STANDARD_ERROR_OF_MEAN|0.32||0.17|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for restrictive feeding scores from T2 to T1|effect size: -0.70|||0.17
71063704|NCT03982511|141636455|SUPERIORITY||Mean Difference (Net)|-0.35|STANDARD_ERROR_OF_MEAN|0.35||0.34|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for restrictive feeding scores from T3 to T1|effect size: -0.51|||0.34
71063705|NCT03982511|141636456|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.23||0.91|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for emotional feeding scores from T2 to T1|effect size: -0.06|||0.91
71063706|NCT03982511|141636456|SUPERIORITY||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.22||0.45|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for emotional feeding scores from T3 to T1|effect size: -0.40|||0.45
71063707|NCT03982511|141636457|SUPERIORITY||Mean Difference (Net)|-0.47|STANDARD_ERROR_OF_MEAN|0.2||0.03|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for instrumental feeding scores from T2 to T1.|effect size: -1.12|||0.03
71063708|NCT03982511|141636457|SUPERIORITY||Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|0.23||0.03|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for instrumental feeding scores from T3 to T1|effect size: -1.25|||0.03
71063709|NCT03982511|141636458|SUPERIORITY||Mean Difference (Net)|2.23|STANDARD_ERROR_OF_MEAN|1.06||0.05|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for active mediation from T2 to T1|effect size: 1.02|||0.05
71063710|NCT03982511|141636458|SUPERIORITY||Mean Difference (Net)|2.5|STANDARD_ERROR_OF_MEAN|1.47||0.11|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for active mediation scores from T3 to T1|effect size: 0.88|||0.11
71063711|NCT03982511|141636459|SUPERIORITY||Mean Difference (Net)|3.64|STANDARD_ERROR_OF_MEAN|1.0||0.002|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for restrictive mediation scores from T2 to T1|effect size: 1.77|||0.002
71063712|NCT03982511|141636459|SUPERIORITY||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|1.08||0.24|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for restrictive mediation scores from T3 to T1|effect size: 0.63|||0.24
71063713|NCT03982511|141636460|SUPERIORITY||Mean Difference (Net)|0.68|STANDARD_ERROR_OF_MEAN|1.05||0.53|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for social coviewing from T2 to T1|effect size: 0.31|||0.53
71078349|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.316|||||TWO_SIDED|95.0|-2.19|2.82|||||Comparison of Day 7, 1 Hour|||2.82|-2.19|
71078350|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.484|||||TWO_SIDED|95.0|-3.99|1.02|||||Comparison of Day 7, 1 Hour|||1.02|-3.99|
71063714|NCT03982511|141636460|SUPERIORITY||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|1.1||0.77|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for social coviewing from T3 to T1|effect size: 0.15|||0.77
71063715|NCT03982511|141636461|SUPERIORITY||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|1.23||0.91|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for number of screens in the home from T2 to T1|effect size: 0.04|||0.91
71063716|NCT03982511|141636461|SUPERIORITY||Mean Difference (Net)|0.65|STANDARD_ERROR_OF_MEAN|1.36||0.64|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for number of screens in the home from T3 to T1|effect size: 0.17|||0.64
71063717|NCT03982511|141636461|SUPERIORITY||Mean Difference (Net)|-0.36|STANDARD_ERROR_OF_MEAN|0.34||0.31|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for number of screens in child bedroom from T2 to T1|effect size: -0.36|||0.31
71063718|NCT03982511|141636461|SUPERIORITY||Mean Difference (Net)|-0.91|STANDARD_ERROR_OF_MEAN|0.39||0.04|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for number of screens in child bedroom from T3 to T1|effect size: -0.85|||0.04
71063719|NCT03982511|141636462|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.03|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided|ANOVA|repeated measures||Difference on difference for TV on during mealtime from T2 to T1|effect size: -1.25|||0.03
71063720|NCT03982511|141636462|SUPERIORITY||Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.19||0.1|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided|ANOVA|repeated measures||Difference on difference for TV on during mealtime from T3 to T1|effect size: -1.08|||0.10
71063721|NCT03982511|141636462|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.41|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for mobile device present during mealtime from T2 to T1|effect size: -0.44|||0.41
71063722|NCT03982511|141636462|SUPERIORITY||Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.22||0.21|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for mobile device present during mealtime from T3 to T1|effect size: -0.80|||0.21
71063723|NCT03982511|141636462|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.16||0.02|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for other media present during mealtime from T2 to T1|effect size: -1.29|||0.02
71063724|NCT03982511|141636462|SUPERIORITY||Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.16||0.2|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for other media present during mealtime from T3 to T1|effect size: -0.82|||0.20
71063725|NCT03982511|141636463|SUPERIORITY||Mean Difference (Net)|0.42|STANDARD_ERROR_OF_MEAN|0.14||0.009|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for mealtime task accomplishment scores from T2 to T1|effect size: 1.55|||0.009
71063726|NCT03982511|141636463|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.15||0.84|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for mealtime task accomplishment scores from T3 to T1|effect size: -0.13|||0.84
71063727|NCT03982511|141636463|SUPERIORITY||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.2||0.24|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for mealtime behavior control scores from T2 to T1|effect size: 0.63|||0.24
71063728|NCT03982511|141636463|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.15||0.84|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for mealtime behavior control scores from T3 to T1.|effect size: -0.13|||0.84
71063729|NCT03982511|141636464|SUPERIORITY||Mean Difference (Net)|-9.5|STANDARD_ERROR_OF_MEAN|2.17||0|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for ECBI intensity t-scores from T2 to T1|effect size: -1.50|||0.00
71078351|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.795|||||TWO_SIDED|95.0|-3.27|1.68|||||Comparison of Day 7, 2 Hours|||1.68|-3.27|
71078352|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.313|||||TWO_SIDED|95.0|-2.78|2.15|||||Comparison of Day 7, 2 Hours|||2.15|-2.78|
71078353|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.441|||||TWO_SIDED|95.0|-0.03|4.91|||||Comparison of Day 7, 2 Hours|||4.91|-0.03|
71078354|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.884|||||TWO_SIDED|95.0|-1.58|3.34|||||Comparison of Day 7, 2 Hours|||3.34|-1.58|
71078355|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.222|||||TWO_SIDED|95.0|-3.69|1.24|||||Comparison of Day 7, 2 Hours|||1.24|-3.69|
71078356|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.017|||||TWO_SIDED|95.0|-2.06|2.03|||||Comparison of Day 7, 4 Hours|||2.03|-2.06|
71063730|NCT03982511|141636464|SUPERIORITY||Mean Difference (Net)|-7.63|STANDARD_ERROR_OF_MEAN|2.48||0.01|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for ECBI intensity t-scores from T3 to T1|effect size: -1.12|||0.01
71063731|NCT03982511|141636465|SUPERIORITY||Mean Difference (Net)|-6.93|STANDARD_ERROR_OF_MEAN|2.63||0.02|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for internalizing symptoms from T2 to T1|effect size: -0.93|||0.02
71063732|NCT03982511|141636465|SUPERIORITY||Mean Difference (Net)|-6.58|STANDARD_ERROR_OF_MEAN|3.56||0.08|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for internalizing symptoms from T3 to T1|effect size: -0.68|||0.08
71063733|NCT03982511|141636465|SUPERIORITY||Mean Difference (Net)|-6.47|STANDARD_ERROR_OF_MEAN|6.92||0.36|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for adaptive skills from T2 to T1|effect size: -0.33|||0.36
71063734|NCT03982511|141636465|SUPERIORITY||Mean Difference (Net)|-3.57|STANDARD_ERROR_OF_MEAN|8.83||0.69|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for adaptive skills from T3 to T1|effect size: -0.15|||0.69
71063735|NCT03982511|141636466|SUPERIORITY||Mean Difference (Net)|35.78|STANDARD_ERROR_OF_MEAN|7.21||0|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for PSICA intensity scores from T2 to T1 (higher scores indicate better outcomes).|effect size: 1.70|||0.000
70937561|NCT03060525|141374938|SUPERIORITY||Mean Difference (Final Values)|-3.36|STANDARD_ERROR_OF_MEAN|1.51||0.026|TWO_SIDED|95.0|-6.32|-0.41|||Mixed Models Analysis|||Difference in weight change from Baseline to 6months, between Immediate Intervention participants (group and videophone combined) vs. Delayed Intervention participants (group and videophone combined). \[analysis of 2 arms, immediate intervention vs. delayed intervention\]||-0.41|-6.32|0.026
70937562|NCT03060525|141374939|SUPERIORITY||Mean Difference (Final Values)|-1.27|STANDARD_ERROR_OF_MEAN|0.59||0.03|TWO_SIDED|95.0|-2.42|-0.12|||Mixed Models Analysis|||Difference in Body Mass Index (BMI) change from Baseline to 6months, between Immediate Intervention participants (group and videophone combined) vs. Delayed Intervention participants (group and videophone combined). \[analysis of 2 arms, immediate intervention vs. delayed intervention\]||-0.12|-2.42|0.03
70937563|NCT03060525|141374940|SUPERIORITY||Median Difference (Net)|247.5||||0.63|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change in amount of physical activity = 6-month MET-minutes/week - baseline MET-minutes/week (change from pre to post intervention), using the International Physical Activity Questionnaire. IPAQ score is a continuous measure and reports median MET-minutes per week (a combination of walking met-minutes/week + moderate activity MET-minutes/week + vigorous activity MET-minutes/week). \[analysis of 2 arms, immediate intervention vs. delayed intervention\]||||0.63
71063736|NCT03982511|141636466|SUPERIORITY||Mean Difference (Net)|21.78|STANDARD_ERROR_OF_MEAN|7.64||0.01|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for PSICA intensity scores from T3 to T1|effect size: 1.04|||0.01
71063737|NCT03982511|141636467|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.73|TWO_SIDED|||||Given this is a pilot RCT, primary aim is to estimate effect size for a more fully-powered RCT. P-values will be provided in addition to effect size.|ANOVA|Repeated measures|Effect size: 0.17|Difference on difference from T2 to T1 for BMI z-score||||.73
71111054|NCT01682356|141728133|SUPERIORITY|||||||2.13e-06||||||P value adjusted for multiplicity. Exact P value 2.129 x 10\^-6.|ANOVA|Breath nitric oxide values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.00000213
71111055|NCT01682356|141728134|SUPERIORITY|||||||0.3918||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.3918
71111056|NCT01682356|141728135|SUPERIORITY|||||||0.0598||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.05980
71063738|NCT03982511|141636467|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.18||0.98|TWO_SIDED|||||Given this is a pilot RCT, primary aim is to estimate effect size for a more fully-powered RCT. P-values will be provided in addition to effect size.|ANOVA|Repeated measures||Difference on difference for BMI z-scores from T3 to T1.|Effect size: -0.01|||.98
71111057|NCT01682356|141728136|SUPERIORITY|||||||0.3918||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.3918
71111058|NCT01682356|141728137|SUPERIORITY|||||||0.0987||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.09870
71063739|NCT00568451|141636470|SUPERIORITY_OR_OTHER||Median|12.5|||||ONE_SIDED|95.0|4.5||||Kaplan-Meier||||||4.5|
71063740|NCT05344560|141636483|NON_INFERIORITY|A non-inferiority margin of -5 points was used.|Mean Difference (Final Values)|-2.92|STANDARD_ERROR_OF_MEAN|2.018|||TWO_SIDED|95.0|-6.92|1.07|||Generalized Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Test \[senofilcon A (C3) HEV chromophore\] minus Control \[senofilcon A (C3)\]|||1.07|-6.92|
71063741|NCT02535026|141636492|SUPERIORITY_OR_OTHER|||||||0.28|||||||Chi-squared|||ER status association with age groups||||0.280
70937564|NCT01974102|141374941|SUPERIORITY||||||<|0.015|||||||t-test, 2 sided|||||||<0.015
70937565|NCT01974102|141374942|SUPERIORITY||||||<|0.03|||||||t-test, 2 sided|||||||<0.03
71063742|NCT02535026|141636493|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||ER status association with nuclear grade.||||<0.001
71063743|NCT02535026|141636494|SUPERIORITY_OR_OTHER||||||=|0.03|||||||Chi-squared|||ER status association with lymphovascular invasion.||||=0.03
71063744|NCT02535026|141636495|SUPERIORITY_OR_OTHER||||||=|0.004|||||||Chi-squared|||PR status association with age groups||||=0.004
71063745|NCT02535026|141636496|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||PR status association with nuclear grade.||||<0.001
71063746|NCT02535026|141636497|SUPERIORITY_OR_OTHER||||||=|0.025|||||||ANOVA|||PR status association with lymphovascular invasion.||||=0.025
71063747|NCT02535026|141636498|SUPERIORITY_OR_OTHER||||||=|0.056|||||||ANOVA|||HER2 status association with age groups.||||=0.056
71063748|NCT02535026|141636499|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||HER2 status association with nuclear grade.||||<0.001
71063749|NCT02535026|141636500|SUPERIORITY_OR_OTHER||||||=|0.129|||||||Chi-squared|||||||=0.129
70937566|NCT01416285|141374987|SUPERIORITY|||||||0.004|||||||Kaplan-Meier and COX regression|Univariate and multi-variable||All-cause death||||0.004
71063750|NCT02535026|141636501|SUPERIORITY_OR_OTHER||||||=|0.003|||||||ANOVA|||Breast cancer phenotypes association with age groups.||||=0.003
71063751|NCT02535026|141636502|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Breast cancer phenotypes association with nuclear grades.||||<0.001
71063752|NCT02535026|141636503|SUPERIORITY_OR_OTHER||||||=|0.001|||||||ANOVA|||phenotypes of breast cancer association with lymphovascular invasion.||||=0.001
71063753|NCT02535026|141636504|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||phenotypes of breast cancer association with ER status.||||<0.001
71063754|NCT02535026|141636505|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Phenotypes of breast cancer association with PR status.||||<0.001
71063755|NCT02535026|141636506|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||phenotypes of breast cancer association with HER2 status.||||<0.001
71063756|NCT00360282|141636525|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Sign test|||||||0.007
71063757|NCT00360282|141636526|SUPERIORITY_OR_OTHER|||||||0.549|TWO_SIDED||||||Sign test|||||||.549
71063758|NCT00925704|141636527|SUPERIORITY_OR_OTHER_LEGACY|||||||0.171||95.0|||||Mixed Models Analysis|||Exogenous calcitriol was analyzed using a mixed linear effects model. This model contained sequence group, period, and treatment as fixed effects. The subject within sequence effect was included as a random effect.||||0.171
71063759|NCT00925704|141636527|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024||95.0|||||Mixed Models Analysis|||Exogenous calcitriol was analyzed using a mixed linear effects model. This model contained sequence group, period, and treatment as fixed effects. The subject within sequence effect was included as a random effect.||||0.024
71063760|NCT00925704|141636528|SUPERIORITY_OR_OTHER_LEGACY|||||||0.313||95.0|||||Mixed Models Analysis|||Exogenous calcitriol was analyzed using a mixed linear effects model. This model contained sequence group, period, and treatment as fixed effects. The subject within sequence effect was included as a random effect.||||0.313
71063761|NCT00925704|141636528|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Mixed Models Analysis|||Exogenous calcitriol was analyzed using a mixed linear effects model. This model contained sequence group, period, and treatment as fixed effects. The subject within sequence effect was included as a random effect.||||< 0.001
71063762|NCT00925704|141636529|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||95.0|||||Wilcoxon (Hodges-Lehmann)|||Analysis for Tmax used the Hodges-Lehmann estimate for Wilcoxon's Signed Rank Test.||||0.039
71063763|NCT00925704|141636529|SUPERIORITY_OR_OTHER_LEGACY|||||||0.305||95.0|||||Wilcoxon (Hodges-Lehmann)|||Analysis for Tmax used the Hodges-Lehmann estimate for Wilcoxon's Signed Rank Test.||||0.305
71078357|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.475|||||TWO_SIDED|95.0|-1.56|2.51|||||Comparison of Day 7, 4 Hours|||2.51|-1.56|
71078358|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.512|||||TWO_SIDED|95.0|-0.53|3.55|||||Comparison of Day 7, 4 Hours|||3.55|-0.53|
71078359|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.233|||||TWO_SIDED|95.0|-0.8|3.26|||||Comparison of Day 7, 4 Hours|||3.26|-0.80|
71078360|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.011|||||TWO_SIDED|95.0|-3.05|1.02|||||Comparison of Day 7, 4 Hours|||1.02|-3.05|
71078361|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.189|||||TWO_SIDED|95.0|-3.05|2.67|||||Comparison of Day 7, 6 Hours|||2.67|-3.05|
71078362|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.456|||||TWO_SIDED|95.0|-2.39|3.3|||||Comparison of Day 7, 6 Hours|||3.30|-2.39|
71078363|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.706|||||TWO_SIDED|95.0|-0.14|5.56|||||Comparison of Day 7, 6 Hours|||5.56|-0.14|
71078364|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.062|||||TWO_SIDED|95.0|-1.78|3.91|||||Comparison of Day 7, 6 Hours|||3.91|-1.78|
71078365|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.708|||||TWO_SIDED|95.0|-5.55|0.14|||||Comparison of Day 7, 6 Hours|||0.14|-5.55|
71078366|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.147|||||TWO_SIDED|95.0|-2.41|2.7|||||Comparison of Day 7, 10 Hours|||2.70|-2.41|
71078367|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.452|||||TWO_SIDED|95.0|-2.09|2.99|||||Comparison of Day 7, 10 Hours|||2.99|-2.09|
71078368|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.418|||||TWO_SIDED|95.0|-0.13|4.96|||||Comparison of Day 7, 10 Hours|||4.96|-0.13|
71078369|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.063|||||TWO_SIDED|95.0|-1.47|3.6|||||Comparison of Day 7, 10 Hours|||3.60|-1.47|
71111059|NCT01682356|141728138|SUPERIORITY|||||||0.6044||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.6044
71111060|NCT01682356|141728139|SUPERIORITY|||||||0.6044||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.6044
71111061|NCT01682356|141728140|SUPERIORITY|||||||0.8819||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.8819
71111062|NCT01682356|141728141|SUPERIORITY|||||||0.8987||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.8987
71111063|NCT02688192|141728207|SUPERIORITY|||||||0.39|||||||ANOVA|df = 33||Effects of the intervention on changes in the General Subscale from baseline to post-intervention (3 months) were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.||||0.39
71111064|NCT02688192|141728207|SUPERIORITY|||||||0.49|||||||ANOVA|df = 33||Effects of the intervention on changes in the Sleep/Rest Subscale from baseline to post-intervention (3 months) were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.||||.49
70937567|NCT01416285|141374987|SUPERIORITY|||||||0.003|||||||Kaplan-Meier and COX regression|Univariate and multi-variable||Heart failure-related re-hospitalizations||||0.003
71111065|NCT02688192|141728207|SUPERIORITY|||||||0.83|||||||ANOVA|df = 33||Effect of the intervention on changes in the Cognitive Subscale from baseline to post-intervention (3 months) were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.||||.83
71111066|NCT02688192|141728208|SUPERIORITY|||||||0.98|||||||ANOVA|df = 33||Effects of the intervention on changes in the PedsQL Physical Summary score were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.||||.98
71111067|NCT02688192|141728208|SUPERIORITY|||||||0.85|||||||ANOVA|df = 29||Effects of the intervention on changes in the PedsQL Psychosocial Summary score were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.||||.85
71111068|NCT02688192|141728209|SUPERIORITY|||||||0.29|||||||ANOVA|df = 29||||||.29
71111069|NCT02688192|141728210|SUPERIORITY|||||||0.019|||||||ANOVA|df = 32||Effect of the intervention on changes in lower body estimated 1-RM was evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data||||.019
71111070|NCT02688192|141728210|SUPERIORITY|||||||0.34|||||||ANOVA|df = 32||Effect of the intervention on changes in upper body estimated 1-RM was evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.||||.34
71111071|NCT01282866|141728230|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71111072|NCT01299389|141728234|SUPERIORITY_OR_OTHER||Least squares (LS) means difference|-9.7|STANDARD_ERROR_OF_MEAN|2.19|<|0.0001|TWO_SIDED|95.0|-14.0|-5.4|||ANCOVA|||Change at Week 13 or Early Discontinuation: P value were calculated using an analysis of covariance (ANCOVA) model with treatment and country as factors and baseline PANSS total score as a covariate.||-5.4|-14.0|<0.0001
71111073|NCT01299389|141728237|SUPERIORITY_OR_OTHER||LS Mean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.69|<|0.0001|TWO_SIDED|95.0|-4.1|-1.4|||ANCOVA|||Positive symptoms (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.||-1.4|-4.1|<0.0001
71111074|NCT01299389|141728237|SUPERIORITY_OR_OTHER||LS Mean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.61||0.0012|TWO_SIDED|95.0|-3.2|-0.8|||ANCOVA|||Negative symptoms (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.||-0.8|-3.2|0.0012
71111075|NCT01299389|141728237|SUPERIORITY_OR_OTHER||LS Mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.57|<|0.0001|TWO_SIDED|95.0|-3.4|-1.1|||ANCOVA|||Disorganized thoughts (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.||-1.1|-3.4|<0.0001
71111076|NCT01299389|141728237|SUPERIORITY_OR_OTHER||LS Mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.45||0.0023|TWO_SIDED|95.0|-2.3|-0.5|||ANCOVA|||Uncontrolled hostility/excitement (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.||-0.5|-2.3|0.0023
71063764|NCT02996968|141636530|NON_INFERIORITY|"Non-inferiority was declared if the POUR rate at 1-week with self-discontinuation was no worse than the POUR rate at 1-week with office-discontinuation, by a pre-specified margin of 15%.~A sample size was calculated to be 74 patients in each arm based on the following:~* The estimated POUR requiring indwelling urinary catheter at 1-week postoperative is 16%~* The non-inferiority margin was set at 15%.~* The power was set at 80%"|Proportion Difference|0.002||||0.5|ONE_SIDED|95.0||0.095||2-sample test for equality of proportions with continuity correction|Two proportions Z-test|||||0.095||0.5
71063765|NCT00216125|141636531|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|10.0||||0.883|TWO_SIDED|95.0|||||Log Rank|||||||0.883
71063766|NCT00449865|141636552|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||Global Statistical Test|The global statistical test yielded t = -0.75 (2-sided p-value = .45, df=1865.8).||||||0.45
71063767|NCT00444535|141636553|OTHER|Clopper-Pearson exact test (binomial)|Exact binomial procedure|69.2||||||95.0|54.9|81.3||||||||81.3|54.9|
71063768|NCT01011816|141636576|SUPERIORITY_OR_OTHER|||||||0.52|||||||Fisher Exact|||Null: No differenc between the percent success of Saline and BIOSTAT BIOLOGX||||0.52
71063769|NCT00558467|141636579|SUPERIORITY_OR_OTHER||Least Squares mean difference|0.01||||0.996|TWO_SIDED|95.0|-4.95|4.97|||ANCOVA|||||4.97|-4.95|0.996
71063770|NCT00558467|141636580|SUPERIORITY_OR_OTHER||Least square means difference|-3.94|||||TWO_SIDED|95.0|-5.81|-2.08|||Repeated Measures|||||-2.08|-5.81|
71063771|NCT00558467|141636581|SUPERIORITY_OR_OTHER||Least square means difference|-5.3|||||TWO_SIDED|95.0|-7.21|-3.39|||Repeated measures|||||-3.39|-7.21|
71063772|NCT00558467|141636583|SUPERIORITY_OR_OTHER||Least square means difference|-5.97|||||TWO_SIDED|95.0|-7.88|-4.06|||Repeated measures|||||-4.06|-7.88|
71063773|NCT00558467|141636584|SUPERIORITY_OR_OTHER||Least Squares Mean differnce|-0.15||||0.978|TWO_SIDED|95.0|-11.05|10.75|||ANCOVA|||||10.75|-11.05|0.9780
71063774|NCT00558467|141636589|SUPERIORITY_OR_OTHER|||||||0.1052|||||||Cochran-Mantel-Haenszel|||||||0.1052
71063775|NCT00558467|141636590|SUPERIORITY_OR_OTHER|||||||0.2274|||||||Cochran-Mantel-Haenszel|||||||0.2274
71063776|NCT00558467|141636591|SUPERIORITY_OR_OTHER|||||||0.7691|||||||Cochran-Mantel-Haenszel|||||||0.7691
70937568|NCT01416285|141374987|SUPERIORITY||||||<|0.001|||||||Kaplan-Meier and COX regression|Univariate and multi-variable||a composite outcome of both death and heart failure-related re-hospitalizations||||<0.001
71063777|NCT00558467|141636592|SUPERIORITY_OR_OTHER|||||||0.0674|||||||Cochran-Mantel-Haenszel|||||||0.0674
71063778|NCT00558467|141636593|SUPERIORITY_OR_OTHER|||||||0.4944|||||||Cochran-Mantel-Haenszel|||||||0.4944
71063779|NCT00558467|141636594|SUPERIORITY_OR_OTHER|||||||0.162|||||||Cochran-Mantel-Haenszel|||||||0.162
71063780|NCT00558467|141636595|SUPERIORITY_OR_OTHER|||||||0.6375|||||||Cochran-Mantel-Haenszel|||||||0.6375
71063781|NCT00558467|141636596|SUPERIORITY_OR_OTHER|||||||0.6625|||||||Cochran-Mantel-Haenszel|||||||0.6625
71063782|NCT00558467|141636597|SUPERIORITY_OR_OTHER|||||||0.2664|||||||Cochran-Mantel-Haenszel|||||||0.2664
71063783|NCT00558467|141636598|SUPERIORITY_OR_OTHER|||||||0.7302|||||||Cochran-Mantel-Haenszel|||||||0.7302
71063784|NCT00558467|141636599|SUPERIORITY_OR_OTHER|||||||0.7723|||||||Cochran-Mantel-Haenszel|||||||0.7723
71063785|NCT00558467|141636600|SUPERIORITY_OR_OTHER|||||||0.4852|||||||Cochran-Mantel-Haenszel|||||||0.4852
71063786|NCT00558467|141636601|SUPERIORITY_OR_OTHER|||||||0.4607|||||||Cochran-Mantel-Haenszel|||||||0.4607
71063787|NCT00558467|141636602|SUPERIORITY_OR_OTHER|||||||0.7723|||||||Cochran-Mantel-Haenszel|||||||0.7723
71063788|NCT00558467|141636603|SUPERIORITY_OR_OTHER|||||||0.9389|||||||Cochran-Mantel-Haenszel|||||||0.9389
71063789|NCT02025725|141636621|SUPERIORITY|||||||0.881|||||||ANCOVA|||||||0.881
71063790|NCT02025725|141636622|SUPERIORITY||Mean Difference (Net)|-0.201||||0.036|TWO_SIDED||||||ANCOVA|||Change in mean daily GSA total score from Baseline to Week 1: metoclopramide nasal spray minus placebo.||||0.036
71063791|NCT02025725|141636622|SUPERIORITY||Mean Difference (Net)|-0.336||||0.025|TWO_SIDED||||||ANCOVA|||Change in mean daily GSA total score from Baseline to Week 2: metoclopramide nasal spray minus placebo||||0.025
71063792|NCT02025725|141636622|SUPERIORITY||Mean Difference (Net)|-0.347||||0.039|TWO_SIDED||||||ANCOVA|||Change in mean daily GSA total score from Baseline to Week 3: metoclopramide nasal spray minus placebo.||||0.039
71063793|NCT02025725|141636622|SUPERIORITY||Mean Difference (Net)|-0.364||||0.085|TWO_SIDED||||||ANCOVA|||Change in mean daily GSA total score from Baseline to Week 4: metoclopramide nasal spray minus placebo.||||0.085
71063794|NCT06509438|141636624|OTHER|Compare 4 weeks after the last injection to baseline|Difference of medians|-0.45|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71063795|NCT06509438|141636624|OTHER|Compare 12 weeks after the last injection to baseline|Difference of medians|-0.4|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71063796|NCT03331796|141636628|SUPERIORITY||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|3.1||0.63|TWO_SIDED|95.0|-4.8|7.9|||Regression, Linear|Adjusted for baseline||||7.9|-4.8|0.63
71063797|NCT03331796|141636628|SUPERIORITY||Mean Difference (Final Values)|6.9|STANDARD_ERROR_OF_MEAN|3.3||0.0476|TWO_SIDED|95.0|0.1|13.7|||Regression, Linear|||||13.7|0.1|0.0476
71063798|NCT03331796|141636629|SUPERIORITY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|4.1||0.45|TWO_SIDED|95.0|-11.4|5.2|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||5.2|-11.4|0.45
71063799|NCT03331796|141636629|SUPERIORITY||Mean Difference (Final Values)|5.7|STANDARD_ERROR_OF_MEAN|4.4||0.21|TWO_SIDED|95.0|-3.3|14.8|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||14.8|-3.3|0.21
71063800|NCT03331796|141636630|SUPERIORITY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.38||0.29|TWO_SIDED|95.0|-0.36|1.19|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||1.19|-0.36|0.29
71063801|NCT03331796|141636630|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.4||0.51|TWO_SIDED|95.0|-0.55|1.08|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||1.08|-0.55|0.51
71063802|NCT03331796|141636631|SUPERIORITY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|1.0||0.33|TWO_SIDED|95.0|-1.0|3.0|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||3.0|-1.0|.33
71063803|NCT03331796|141636631|SUPERIORITY||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|1.0||0.0038|TWO_SIDED|95.0|1.1|5.3|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||5.3|1.1|0.0038
70937569|NCT02935673|141374997|SUPERIORITY||AUC(1-7) difference vs (pooled) placebo|-0.32|||||TWO_SIDED|95.0|-0.89|0.24|||||||Mixed model for repeated measures, using all available viral load data of baseline and up to and including Day 7, taking missing data into account under the missing at random assumption.|0.24|-0.89|
70937570|NCT02935673|141374997|SUPERIORITY||AUC(1-7) difference vs (pooled) placebo|-0.36|||||TWO_SIDED|95.0|-1.33|0.62|||||||Mixed model for repeated measures, using all available viral load data of baseline and up to and including Day 7, taking missing data into account under the missing at random assumption.|0.62|-1.33|
70937571|NCT01020435|141375140|OTHER||Mean Difference (Final Values)|4.1|||||TWO_SIDED|95.0|-0.9|9.2||||||Tx 1 - SBP (Unadjusted)||9.2|-0.9|
70937572|NCT01020435|141375140|OTHER||Mean Difference (Final Values)|2.5|||||TWO_SIDED|95.0|-0.4|5.3||||||Tx 1 - DBP (Unadjusted)||5.3|-0.4|
70937573|NCT01020435|141375140|OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-6.2|5.6||||||Wk 3 - SBP (Unadjusted)||5.6|-6.2|
70937574|NCT01020435|141375140|OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-4.0|3.5||||||Wk 3 - DBP (Unadjusted)||3.5|-4.0|
71063804|NCT03331796|141636632|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.78||0.58|TWO_SIDED|95.0|-1.1|2.0|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||2.0|-1.1|0.58
71063805|NCT03331796|141636632|SUPERIORITY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.86||0.59|TWO_SIDED|95.0|-2.2|1.3|||Regression, Linear|Adjusted for baseline||||1.3|-2.2|0.59
71063806|NCT03331796|141636633|SUPERIORITY||Mean Difference (Final Values)|5.5|STANDARD_ERROR_OF_MEAN|5.2||0.3|TWO_SIDED|95.0|-5.2|16.1|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||16.1|-5.2|0.30
71063807|NCT03331796|141636633|SUPERIORITY||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|4.9||0.34|TWO_SIDED|95.0|-14.9|5.3|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||5.3|-14.9|0.34
71063808|NCT03331796|141636634|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|10.6||0.996|TWO_SIDED|95.0|-22.0|22.1|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||22.1|-22.0|0.996
71063809|NCT03331796|141636634|SUPERIORITY||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|10.8||0.87|TWO_SIDED|95.0|-20.6|24.3|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||24.3|-20.6|0.87
71063810|NCT03331796|141636635|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|1.06||0.97|TWO_SIDED|95.0|-2.14|2.22|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||2.22|-2.14|0.97
71063811|NCT03331796|141636635|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|1.11||0.91|TWO_SIDED|95.0|-2.15|2.41|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||2.41|-2.15|0.91
71063812|NCT03331796|141636636|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_DEVIATION|1.0||0.84|TWO_SIDED|95.0|-2.3|1.9|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||1.9|-2.3|0.84
71063813|NCT03331796|141636636|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|1.0||0.8|TWO_SIDED|95.0|-1.9|2.4|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||2.4|-1.9|0.80
71063814|NCT03331796|141636637|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|2.0||0.48|TWO_SIDED|95.0|-5.5|2.6|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||2.6|-5.5|0.48
71063815|NCT03331796|141636637|SUPERIORITY||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|2.0||0.18|TWO_SIDED|95.0|-6.8|1.3|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||1.3|-6.8|0.18
71063816|NCT03331796|141636638|SUPERIORITY||Median Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|1.5||0.075|TWO_SIDED|95.0|-5.7|0.3|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||0.3|-5.7|0.075
71063817|NCT03331796|141636638|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|1.6||0.195|TWO_SIDED|95.0|-5.4|1.1|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||1.1|-5.4|0.195
71063818|NCT03331796|141636639|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.1||0.28|TWO_SIDED|95.0|-1.0|3.4|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||3.4|-1.0|0.28
70937575|NCT01020435|141375140|OTHER||Mean Difference (Final Values)|3.5|||||TWO_SIDED|95.0|-1.9|8.9||||||Wk 6 - SBP (Unadjusted)||8.9|-1.9|
70937576|NCT01020435|141375140|OTHER||Mean Difference (Final Values)|1.5|||||TWO_SIDED|95.0|-2.1|5.0||||||Wk 6 - DBP (Unadjusted)||5.0|-2.1|
70937577|NCT01020435|141375140|OTHER||Mean Difference (Final Values)|4.7|||||TWO_SIDED|95.0|-0.4|9.8||||||Tx 1 - SBP (Adjusted)||9.8|-0.4|
70937578|NCT01020435|141375140|OTHER||Mean Difference (Final Values)|3.6|||||TWO_SIDED|95.0|0.6|6.5||||||Tx 1 - DBP (Adjusted)||6.5|0.6|
70937579|NCT01020435|141375140|OTHER||Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0|-5.0|6.9||||||Wk 3 - SBP (Adjusted)||6.9|-5.0|
70937580|NCT01020435|141375140|OTHER||Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.8|4.9||||||Wk 3 - DBP (Adjusted)||4.9|-2.8|
71063819|NCT03331796|141636639|SUPERIORITY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|1.1||0.21|TWO_SIDED|95.0|-0.8|3.6|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||3.6|-0.8|0.21
71078370|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.509|||||TWO_SIDED|95.0|-4.05|1.03|||||Comparison of Day 7, 10 Hours|||1.03|-4.05|
70937581|NCT01020435|141375140|OTHER||Mean Difference (Final Values)|4.8|||||TWO_SIDED|95.0|-0.4|10.0||||||Wk 6 - SBP (Adjusted)||10.0|-0.4|
70937582|NCT01020435|141375140|OTHER||Mean Difference (Final Values)|2.3|||||TWO_SIDED|95.0|-1.2|5.8||||||Wk 6 - DBP (Adjusted)||5.8|-1.2|
70937583|NCT02978183|141375152|SUPERIORITY|||||||0.0882||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.0882
70937584|NCT02978183|141375152|SUPERIORITY|||||||0.8032||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 5 Minutes Post-CAC||||0.8032
70937585|NCT02978183|141375152|SUPERIORITY|||||||0.9003||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 7 Minutes Post-CAC||||0.9003
70937586|NCT02978183|141375152|SUPERIORITY|||||||0.9523||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Post-CAC||||0.9523
71063820|NCT03331796|141636640|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.3||0.66|TWO_SIDED|95.0|-3.2|2.1|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||2.1|-3.2|0.66
70937587|NCT02978183|141375152|SUPERIORITY|||||||0.9071||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.9071
70937588|NCT02978183|141375152|SUPERIORITY|||||||0.7509||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.7509
70937589|NCT02978183|141375152|SUPERIORITY|||||||0.2824||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.2824
71063821|NCT03331796|141636640|SUPERIORITY||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|1.3||0.11|TWO_SIDED|95.0|-4.9|0.5|||Regression, Linear|||a priori threshold for statistical significance = .05||0.5|-4.9|0.11
71063822|NCT03331796|141636641|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.11||0.59|TWO_SIDED|95.0|-0.29|0.17|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||0.17|-0.29|0.59
71063823|NCT03331796|141636641|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.64|TWO_SIDED|95.0|-0.17|0.28|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||0.28|-0.17|0.64
70937590|NCT02978183|141375152|SUPERIORITY|||||||0.4017||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.4017
70937591|NCT02978183|141375152|SUPERIORITY|||||||0.4497||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.4497
70937592|NCT02978183|141375152|SUPERIORITY|||||||0.165||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.1650
71063824|NCT03331796|141636644|SUPERIORITY|||||||0.768||||||a priori threshold for statistical significance = .05|ANOVA|||||||0.768
70937593|NCT02978183|141375152|SUPERIORITY|||||||0.3494||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 5 Minutes Post-CAC||||0.3494
70937594|NCT02978183|141375152|SUPERIORITY|||||||0.4781||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 7 Minutes Post-CAC||||0.4781
70937595|NCT02978183|141375152|SUPERIORITY|||||||0.9847||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.9847
70937596|NCT02978183|141375152|SUPERIORITY|||||||0.9731||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.9731
70937597|NCT02978183|141375152|SUPERIORITY|||||||0.6984||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.6984
70937598|NCT02978183|141375152|SUPERIORITY|||||||0.6265||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.6265
71063825|NCT02565628|141636689|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.02|STANDARD_ERROR_OF_MEAN|10.49||0.6382|ONE_SIDED|90.0||8.97|||Mixed Models Analysis|||||8.97||0.6382
71063826|NCT04227197|141636717|SUPERIORITY|The p value compares the trend in the number of indicated or completed evaluations in the Intervention arm versus Control arm.||||||0.018|||||||Cochran-Armitage trend test|Two tailed; no continuity correction||||||0.018
70937599|NCT02978183|141375152|SUPERIORITY|||||||0.7848||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.7848
70937600|NCT02978183|141375152|SUPERIORITY|||||||0.5789||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.5789
71063827|NCT04227197|141636719|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group.||||||0.468|||||||ANOVA|||This is the p value for the PedsQL Psychosocial Health Score||||0.468
71063828|NCT04227197|141636719|SUPERIORITY|||||||0.802|||||||ANOVA|||This p value is for the PedsQL Physical Functioning Score||||0.802
71063829|NCT04227197|141636719|SUPERIORITY|||||||0.761|||||||ANOVA|||This is the p value for the PedsQL Total Scale Score||||0.761
71063830|NCT04227197|141636719|SUPERIORITY|||||||0.965|||||||ANOVA|||This is the p value for the PedsQL FIM Parental HRQL Summary Score||||0.965
71063831|NCT04227197|141636719|SUPERIORITY|||||||0.619|||||||ANOVA|||This is the p value for the PedsQL FIM Family Functioning Summary Score||||0.619
71063832|NCT04227197|141636719|SUPERIORITY|||||||0.469|||||||ANOVA|||This is the p value for the PedsQL FIM Total Scale Score||||0.469
71063833|NCT04227197|141636720|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group||||||0.068|||||||ANOVA|||This is for the change from baseline on PedsQL Psychosocial Health Score||||0.068
71063834|NCT04227197|141636720|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group||||||0.907|||||||ANOVA|||This is for the change from baseline for PedsQL Physical Functioning Score||||0.907
71063835|NCT04227197|141636720|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group||||||0.196|||||||ANOVA|||This is for the change from baseline for PedsQL Total Scale Score||||0.196
71063836|NCT04227197|141636720|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group||||||0.112|||||||ANOVA|||This is for the change from baseline for PedsQL FIM Parental HRQL Summary Score||||0.112
70937601|NCT02978183|141375153|SUPERIORITY|||||||0.8165||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.8165
70937602|NCT02978183|141375153|SUPERIORITY|||||||0.659||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Post-CAC||||0.6590
71111077|NCT01299389|141728237|SUPERIORITY_OR_OTHER||LS Mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.37||0.0025|TWO_SIDED|95.0|-1.9|-0.4|||ANCOVA|||Anxiety/depression (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.||-0.4|-1.9|0.0025
71111078|NCT01299389|141728238|SUPERIORITY_OR_OTHER||LS Mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.59||0.0003|TWO_SIDED|95.0|-3.3|-1.0|||ANCOVA|||Change at Week 13 or Early Discontinuation: P value were calculated using an ANCOVA model with treatment and country as factors and baseline PANSS total score as a covariate.||-1.0|-3.3|0.0003
71111079|NCT01299389|141728239|SUPERIORITY_OR_OTHER||LS Mean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-4.1|-1.5|||ANCOVA|||Change at Week 13 or Early Discontinuation: P value were calculated using an ANCOVA model with treatment and country as factors and baseline PANSS total score as a covariate.||-1.5|-4.1|<0.0001
71111080|NCT01299389|141728240|SUPERIORITY_OR_OTHER||LS Mean difference|-4.6|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-6.9|-2.3|||ANCOVA|||Change at Week 13 or Early Discontinuation: P value were calculated using an ANCOVA model with treatment and country as factors and baseline PANSS total score as a covariate.||-2.3|-6.9|<0.0001
71111081|NCT01151020|141728241|SUPERIORITY_OR_OTHER_LEGACY||Free from major adverse event rate (%)|96.4|||<|0.001|TWO_SIDED|95.0|91.0|99.0|||Exact binomial test|||Null hypothesis: The 30-day freedom from MAE for patients treated with the Zenith® TX2® Low Profile TAA Endovascular Graft does not meet the performance goal of 80.6%.||99|91|< 0.001
70937603|NCT02978183|141375153|SUPERIORITY|||||||0.7455||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.7455
70937604|NCT02978183|141375153|SUPERIORITY|||||||0.9212||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.9212
70937605|NCT02978183|141375153|SUPERIORITY|||||||0.9509||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.9509
70937606|NCT02978183|141375153|SUPERIORITY|||||||0.7897||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.7897
70937607|NCT02978183|141375153|SUPERIORITY|||||||0.3183||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.3183
70937608|NCT02978183|141375153|SUPERIORITY|||||||0.7604||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.7604
70937609|NCT02978183|141375153|SUPERIORITY|||||||0.7343||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.7343
70937610|NCT02978183|141375153|SUPERIORITY|||||||0.153||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.1530
70937611|NCT02978183|141375153|SUPERIORITY|||||||0.3307||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.3307
70937612|NCT02978183|141375153|SUPERIORITY|||||||0.3399||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.3399
71111082|NCT01151020|141728242|SUPERIORITY_OR_OTHER_LEGACY||Device success rate (%)|92.7|||<|0.001|TWO_SIDED|95.0|86.2|96.8|||Exact binomial test|||Null Hypothesis: The 12-month device success for patients treated with the Zenith® TX2® Low Profile TAA Endovascular Graft does not meet the performance goal of 80.7%.||96.8|86.2|< 0.001
71111083|NCT03502915|141728289|EQUIVALENCE|The equivalence margin is the standard error of the estimated difference.|Mean Difference (Final Values)|0.053|STANDARD_DEVIATION|2.508||0.943|TWO_SIDED|95.0|-1.402|1.507|||t-test, 2 sided|||||1.507|-1.402|0.943
71111084|NCT03502915|141728290|EQUIVALENCE|The equivalence margin is the standard error of the estimated difference.|Mean Difference (Final Values)|0.443|STANDARD_DEVIATION|2.867||0.597|TWO_SIDED|95.0|-1.229|2.114|||t-test, 2 sided|||||2.114|-1.229|0.597
71111085|NCT03502915|141728291|EQUIVALENCE|The equivalence margin is the standard error of the estimated difference.|Mean Difference (Final Values)|0.12|STANDARD_DEVIATION|1.28||0.748|TWO_SIDED|95.0|-0.629|0.869|||t-test, 2 sided|||||0.869|-0.629|0.748
70937613|NCT02978183|141375153|SUPERIORITY|||||||0.5137||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.5137
71111086|NCT03502915|141728292|EQUIVALENCE|The equivalence margin is the standard error of the estimated difference.|Mean Difference (Final Values)|-2.634|STANDARD_DEVIATION|3.816||0.025|TWO_SIDED|95.0|-4.927|-0.341|||t-test, 2 sided|||||-0.341|-4.927|0.025
71111087|NCT03502915|141728293|EQUIVALENCE|The equivalence margin is the standard error of the estimated difference.|Mean Difference (Final Values)|0.056|STANDARD_DEVIATION|2.742||0.944|TWO_SIDED|95.0|-1.543|1.655|||t-test, 2 sided|||||1.655|-1.543|0.944
71111088|NCT01107964|141728315|SUPERIORITY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||||||0.61
71111089|NCT01107964|141728316|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
71111090|NCT01107964|141728317|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||||||0.44
71111091|NCT01107964|141728318|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
71111092|NCT00362882|141728326|SUPERIORITY|||||||0.17|||||||Log Rank|||||||0.17
70937614|NCT02978183|141375153|SUPERIORITY|||||||0.9962||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.9962
70937615|NCT02978183|141375154|SUPERIORITY|||||||0.3259||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.3259
71063837|NCT04227197|141636720|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group||||||0.245|||||||ANOVA|||This is for change from baseline for PedsQL FIM Family Functioning Summary Score||||0.245
71063838|NCT04227197|141636720|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group||||||0.219|||||||ANOVA|||This is for change from baseline for PedsQL FIM Total Scale Score||||0.219
70937616|NCT02978183|141375154|SUPERIORITY|||||||0.9785||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Post-CAC||||0.9785
71063839|NCT02992236|141636728|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71063840|NCT03446027|141636731|OTHER|"Prespecified Tobit Regression mode: the model included the AWD baseline measurement, a treatment indicator and the type of centre (SET versus non-SET) as covariates. As the data collected for AWD showed a right-skewed distribution, a square root transformation was used to normalise the data and used for the regression Tobit model. This resulted in the unit of measure being units rather than meters."|square root transformation|0.835||||0.28|TWO_SIDED|95.0|-0.674|2.343|||Tobit Regression|||"Right censored Tobit regression model for AWD at 3 months for the ITT population.~Difference between arms (between baseline and 3 months) - the primary analysis estimates the difference in the AWD at 3 months between the two treatment groups control vs. device. Control group includes both BMT and BMT + SET and the treatment group includes NMES + BMT and NMES + BMT + SET Included participants with both baseline and 3 month treadmill data."||2.343|-0.674|0.28
71063841|NCT03446027|141636732|OTHER|"Right censored, Tobit Regression model to assess the effects of baseline characteristics for ICD at 3 months for the ITT Population. This resulted in the unit of measure being units and not meters.~Included participants with both baseline and 3 month treadmill data. Calculation between arms - estimates the difference in the ICD at 3 months between the two treatment groups.~Control group includes both BMT and BMT + SET and the treatment group includes NMES + BMT and NMES + BMT + SET"|square root transformation|0.972||||0.23|TWO_SIDED|95.0|-0.6|2.546|||Right censored, Tobit Regression|||||2.546|-0.600|0.23
71063842|NCT03446027|141636736|OTHER|"Linear Regression Model for Duplex ultrasonography (Volume flow - measured in one leg) at 3 months for the ITT population.~Difference (calculation) between the two groups and not per arm (control vs treatment). Unit of measure is Units due to the use of a linear regression model rather than cc/min."|Linear regression|0.483||||0.516|TWO_SIDED|95.0|-0.984|1.95|||Regression, Linear|||||1.950|-0.984|0.516
71063843|NCT04556305|141636790|SUPERIORITY|||||||0.409|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.409
71063844|NCT04556305|141636790|SUPERIORITY|||||||0.456|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.456
71063845|NCT04556305|141636790|SUPERIORITY|||||||0.692|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.692
71063846|NCT04556305|141636791|SUPERIORITY|||||||0.179|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.179
71063847|NCT04556305|141636791|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.910
71063848|NCT04556305|141636791|SUPERIORITY|||||||0.159|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.159
71063849|NCT04556305|141636792|SUPERIORITY|||||||0.078|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.078
70937617|NCT02978183|141375154|SUPERIORITY|||||||0.5112||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.5112
70937618|NCT02978183|141375154|SUPERIORITY|||||||0.7771||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.7771
70937619|NCT02978183|141375154|SUPERIORITY|||||||0.6232||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.6232
70937620|NCT02978183|141375154|SUPERIORITY|||||||0.8895||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.8895
70937621|NCT02978183|141375154|SUPERIORITY|||||||0.8974||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.8974
71063850|NCT04556305|141636792|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.130
71063851|NCT04556305|141636792|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.430
71063852|NCT04556305|141636793|SUPERIORITY|||||||0.772|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.772
71063853|NCT04556305|141636793|SUPERIORITY|||||||0.107|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.107
71063854|NCT04556305|141636793|SUPERIORITY|||||||0.915|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.915
71111093|NCT00906178|141728338|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.57|1.94||||||||1.94|.57|
71111094|NCT00906178|141728339|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.62|1.65||||||||1.65|.62|
71111095|NCT00906178|141728340|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56|||||TWO_SIDED|95.0|0.93|2.62||||||||2.62|.93|
71111096|NCT00906178|141728341|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.37|1.3||||||||1.30|.37|
71111097|NCT03328832|141728364|EQUIVALENCE|equivalence means p value \> 0.05||||||0.276|||||||t-test, 2 sided|||||||0.276
70937622|NCT02978183|141375154|SUPERIORITY|||||||0.9604||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.9604
70937623|NCT02978183|141375154|SUPERIORITY|||||||0.5301||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 minutes Post-CAC||||0.5301
70937624|NCT02978183|141375154|SUPERIORITY|||||||0.0386||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.0386
70937625|NCT02978183|141375154|SUPERIORITY|||||||0.1034||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.1034
70937626|NCT02978183|141375154|SUPERIORITY|||||||0.0985||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.0985
71063855|NCT04556305|141636794|SUPERIORITY|||||||0.078|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.078
71063856|NCT04556305|141636794|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.130
71063857|NCT04556305|141636794|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.430
71063858|NCT04556305|141636795|SUPERIORITY|||||||0.487|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.487
71063859|NCT04556305|141636795|SUPERIORITY|||||||0.827|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.827
71063860|NCT04556305|141636795|SUPERIORITY|||||||0.908|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.908
71063861|NCT04556305|141636796|SUPERIORITY|||||||0.371|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.371
71063862|NCT04556305|141636796|SUPERIORITY|||||||0.633|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.633
71111098|NCT03328832|141728365|EQUIVALENCE|equivalence means p value \> 0.05||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
71111099|NCT03328832|141728366|EQUIVALENCE|Equivalence means p value \> 0.05||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
71111100|NCT00873821|141728369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.83|||<|0.001|TWO_SIDED|95.0|26.33|55.32|||Mixed Models Analysis|||Difference (placebo minus MK-0941) in change from baseline to Day 13||55.32|26.33|<0.001
70937627|NCT02978183|141375154|SUPERIORITY|||||||0.2342||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.2342
71063863|NCT04556305|141636796|SUPERIORITY|||||||0.23|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.230
71063864|NCT04556305|141636797|SUPERIORITY|||||||0.798|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.798
71063865|NCT04556305|141636797|SUPERIORITY|||||||0.461|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.461
71063866|NCT04556305|141636797|SUPERIORITY|||||||0.419|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.419
71063867|NCT04556305|141636798|SUPERIORITY|||||||0.619|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.619
71063868|NCT04556305|141636798|SUPERIORITY|||||||0.468|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.468
71063869|NCT04556305|141636798|SUPERIORITY|||||||0.387|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.387
71111101|NCT00778336|141728370|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \> 0.||||||<0.0001
71111102|NCT00778336|141728370|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \> 0.||||||<0.0001
71111103|NCT00778336|141728370|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \> 0.||||||<0.0001
71111104|NCT00778336|141728370|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \> 0.||||||<0.0001
71111105|NCT01166347|141728426|NON_INFERIORITY|The non-inferiority margin was 15%.|Difference in Percentages|3.7||||0.011|ONE_SIDED|95.0||12.56|||Wald test||Difference = Control - HeartWare|Primary endpoint is 2 year survival free from disabling stroke (Modified Rankin Scale \>=4), death, exchange, explant due to device malfunction or urgent transplantation. Subjects who are electively transplanted or explanted due to recovery (no disabling stroke) must survive to 2 years post original implant to be considered a success.||12.56||0.0110
71117648|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
71117649|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
70937628|NCT02978183|141375154|SUPERIORITY|||||||0.3016||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.3016
70937629|NCT02978183|141375155|SUPERIORITY|||||||0.4927||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.4927
70937630|NCT02978183|141375155|SUPERIORITY|||||||0.8686||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 minutes Post-CAC||||0.8686
70937631|NCT02978183|141375155|SUPERIORITY|||||||0.5772||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.5772
71117650|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
70937632|NCT02978183|141375155|SUPERIORITY|||||||0.97||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.9700
71063870|NCT04556305|141636799|SUPERIORITY|||||||0.38|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.380
71063871|NCT04556305|141636799|SUPERIORITY|||||||0.759|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.759
70937633|NCT02978183|141375155|SUPERIORITY|||||||0.7516||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.7516
71063872|NCT04556305|141636799|SUPERIORITY|||||||0.219|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.219
71063873|NCT04556305|141636800|SUPERIORITY|||||||0.995|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.995
71063874|NCT04556305|141636800|SUPERIORITY|||||||0.946|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.946
71063875|NCT04556305|141636800|SUPERIORITY|||||||0.593|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.593
71063876|NCT04556305|141636801|SUPERIORITY|||||||0.092|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.092
71063877|NCT04556305|141636801|SUPERIORITY|||||||0.245|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.245
71063878|NCT04556305|141636801|SUPERIORITY|||||||0.107|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.107
71063879|NCT04556305|141636802|SUPERIORITY|||||||0.244|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.244
71063880|NCT04556305|141636802|SUPERIORITY|||||||0.085|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.085
71063881|NCT04556305|141636802|SUPERIORITY|||||||0.71|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.710
70937634|NCT02978183|141375155|SUPERIORITY|||||||0.9532||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.9532
71063882|NCT04556305|141636803|SUPERIORITY|||||||0.491|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.491
71063883|NCT04556305|141636803|SUPERIORITY|||||||0.444|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.444
71063884|NCT04556305|141636803|SUPERIORITY|||||||0.279|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.279
71063885|NCT03808948|141636811|OTHER||Odds Ratio (OR)|0.62||||0.4842|TWO_SIDED|95.0|0.08|1.97|||Regression, Logistic|||Binary logistic regression with mGFR/eGFR ratio as independent variate, AKI as binary outcome||1.97|0.08|0.4842
70937635|NCT02978183|141375155|SUPERIORITY|||||||0.7522||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.7522
71063886|NCT03207815|141636814|SUPERIORITY||Difference in Treatment Failure Rate|-30.1||||0.0064|TWO_SIDED|95.0|-56.2|-4.1||P-value was estimated from the Cochran-Mantel-Haenszel (CMH) test, adjusted for the stratification factors.|Cochran-Mantel-Haenszel|Participants with missing values on treatment failure status were analyzed as treatment failures using a nonresponder imputation (NRI) method.||||-4.1|-56.2|0.0064
71063887|NCT03207815|141636815|SUPERIORITY||Stratified Hazard Ratio|0.309||||0.0014|TWO_SIDED|95.0|0.144|0.663||P-value was derived from the log rank test stratified by the stratification factors.|Stratified Log-Rank Test||Stratified hazard ratio (95% confidence interval \[CI\]) were derived from the Cox model stratified by the stratification factors.|||0.663|0.144|0.0014
71078371|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3|||||TWO_SIDED|95.0|-4.2|1.6|||||Comparison of Day 7, 12 Hours|||1.60|-4.20|
71078372|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.325|||||TWO_SIDED|95.0|-4.21|1.56|||||Comparison of Day 7, 12 Hours|||1.56|-4.21|
71078373|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|-1.89|3.89|||||Comparison of Day 7, 12 Hours|||3.89|-1.89|
71078374|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.265|||||TWO_SIDED|95.0|-3.14|2.62|||||Comparison of Day 7, 12 Hours|||2.62|-3.14|
71078375|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.516|||||TWO_SIDED|95.0|-3.4|2.37|||||Comparison of Day 7, 12 Hours|||2.37|-3.40|
71078376|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.515|||||TWO_SIDED|95.0|-2.29|1.26|||||Comparison of Day 14, 24 Hours|||1.26|-2.29|
71078377|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.225|||||TWO_SIDED|95.0|-1.99|1.55|||||Comparison of Day 14, 24 Hours|||1.55|-1.99|
71078378|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.501|||||TWO_SIDED|95.0|-1.28|2.28|||||Comparison of Day 14, 24 Hours|||2.28|-1.28|
70937636|NCT02978183|141375155|SUPERIORITY|||||||0.6804||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.6804
70937637|NCT02978183|141375155|SUPERIORITY|||||||0.6267||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.6267
71063888|NCT03207815|141636816|SUPERIORITY||Least Squares Mean Treatment Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.355|TWO_SIDED|95.0|-0.4|0.2||P-value was estimated using a repeated measure Analysis of Covariance (ANCOVA) model which included treatment, eye, interaction of treatment and eye, stratification factors and best state value.|Repeated Measure ANCOVA|The repeated measure ANCOVA model was used to control for the clustered observations from each eye of a participant.|Treatment difference in Least Squares (LS)-means (95% CI) were obtained from the repeated measure ANCOVA model.|||0.2|-0.4|0.3550
71063889|NCT03207815|141636817|SUPERIORITY||LS Mean Treatment Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0145|TWO_SIDED|95.0|-0.8|-0.1||P-value was estimated using a repeated measure ANCOVA model which included treatment, eye, interaction of treatment and eye, stratification factors and best state value.|Repeated Measure ANCOVA|The repeated measure ANCOVA model was used to control for the clustered observations from each eye of a participant.|Treatment difference in LS-means (95% CI) were obtained from the repeated measure ANCOVA model.|||-0.1|-0.8|0.0145
71063890|NCT03207815|141636818|SUPERIORITY||LS Mean Treatment Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.025||0.0389|TWO_SIDED|95.0|-0.1|0.0||P-value was estimated using a repeated measure ANCOVA model which included treatment, eye, interaction of treatment and eye, stratification factors and best state value.|Repeated Measure ANCOVA|The repeated measure ANCOVA model was used to control for the clustered observations from each eye of a participant.|Treatment difference in LS-means (95% CI) were obtained from the repeated measure ANCOVA model.|||-0.00|-0.10|0.0389
71063891|NCT03207815|141636819|SUPERIORITY||LS Mean Treatment Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.011||0.034|TWO_SIDED|95.0|-0.05|0.0||P-value was estimated using a repeated measure ANCOVA model which included treatment, eye, interaction of treatment and eye, OCT machine, and best state value.|Repeated Measure ANCOVA|The repeated measure ANCOVA model was used to control for the clustered observations from each eye of a participant.|Treatment difference in LS-means (95% CI) were obtained from the repeated measure ANCOVA model.|||-0.00|-0.05|0.0340
71063892|NCT03207815|141636820|SUPERIORITY||Stratified Hazard Ratio|1.193||||0.5893|TWO_SIDED|95.0|0.625|2.277||P-value was derived from the log rank test stratified by the stratification factors.|Stratified Log-Rank Test||Stratified hazard ratio (95% CI) were derived from the Cox model stratified by the stratification factors.|||2.277|0.625|0.5893
71063893|NCT01671007|141636823|OTHER||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.64|1.08|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.08|0.64|
71063894|NCT01671007|141636824|OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.7|1.27|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.27|0.70|
71063895|NCT01671007|141636825|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.43|1.06|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.06|0.43|
71063896|NCT01671007|141636826|OTHER||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.43|1.09|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.09|0.43|
71063897|NCT01671007|141636830|OTHER||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.38|0.88|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous myocardial infarction, abnormal kidney function, concomitant antiplatelets use and concomitant use of drugs related to bleeding.||0.88|0.38|
71063898|NCT01671007|141636833|OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.49|1.84|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous myocardial infarction, concomitant antiplatelets use, concomitant use of drugs related to bleeding, hypertension, and diabetes.||1.84|0.49|
70937638|NCT02978183|141375155|SUPERIORITY|||||||0.0976||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.0976
70937639|NCT02978183|141375155|SUPERIORITY|||||||0.4687|||||||ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.4687
70937640|NCT02978183|141375155|SUPERIORITY|||||||0.0421||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.0421
70937641|NCT02978183|141375155|SUPERIORITY|||||||0.6085||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.6085
71078379|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.168|||||TWO_SIDED|95.0|-1.98|1.65|||||Comparison of Day 14, 24 Hours|||1.65|-1.98|
71078380|NCT01119846|141664796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.043|||||TWO_SIDED|95.0|-2.81|0.73|||||Comparison of Day 14, 24 Hours|||0.73|-2.81|
71063899|NCT01671007|141636834|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.6|1.01|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.01|0.60|
70937642|NCT02978183|141375155|SUPERIORITY|||||||0.9634||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.9634
71063900|NCT00391768|141636841|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Spearman Correlation|||||||0.07
71063901|NCT00391768|141636841|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Spearman Correlation|||||||0.60
71063902|NCT00391768|141636841|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Spearman Correlation|||||||0.27
71063903|NCT00391768|141636841|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||Spearman Correlation|||||||0.77
71063904|NCT00391768|141636841|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||Spearman Correlation|||||||0.47
71063905|NCT00391768|141636841|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||Spearman Correlation|||||||0.96
71063906|NCT00406367|141636843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|||<|0.001|TWO_SIDED|95.0|-1.4|-0.5||No type I-error adjustment was necessary in this study.|ANCOVA|Indepent variables in the model were treatment, baseline JRS-Severity score, gender, age, dose, and pooled center.||The null hypothesis in the analysis of covariance (ANCOVA) model was the absence of difference in the change from baseline in the JRS severity subscore between incobotulinumtoxinA (Xeomin) and placebo. The ANCOVA model was performed 2-sided (type-I error=5 percent) and change from baseline in the JRS Severity subscore assessed by a blinded Independent Rater as dependent variable. The independent variables were treatment, baseline JRS Severity subscore, gender, age, dose group, and pooled center.||-0.5|-1.4|<0.001
70937643|NCT02978183|141375156|SUPERIORITY|||||||0.3322||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.3322
71063907|NCT03187301|141636863|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% confidence intervals (CIs) for APL-130277 versus placebo fell below 10 msec.|Least Square (LS) Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|0.5|7.4||||||15 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The mixed model for repeated measurements (MMRM) included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||7.4|0.5|
71063908|NCT03187301|141636863|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% CIs for APL-130277 versus placebo fell below 10 msec.|Least Square (LS) Mean difference|3.0|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|-0.5|6.5||||||30 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||6.5|-0.5|
71063909|NCT03187301|141636863|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% CIs for APL-130277 versus placebo fell below 10 msec.|Least Square (LS) Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|0.2|7.2||||||45 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||7.2|0.2|
71078381|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-70.457|||||TWO_SIDED|95.0|-214.72|73.8|||||Day 7, 1 Hour|||73.80|-214.72|
71078382|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-151.722|||||TWO_SIDED|95.0|-295.98|-7.46|||||Day 7, 1 Hour|||-7.46|-295.98|
71078383|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-69.113|||||TWO_SIDED|95.0|-213.48|75.25|||||Day 7, 1 Hour|||75.25|-213.48|
70937644|NCT02978183|141375156|SUPERIORITY|||||||0.8026||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Pre-CAC||||0.8026
71063910|NCT03187301|141636863|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% CIs for APL-130277 versus placebo fell below 10 msec.|Least Square (LS) Mean Difference|6.2|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|2.7|9.7||||||60 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||9.7|2.7|
71063911|NCT03187301|141636863|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% CIs for APL-130277 versus placebo fell below 10 msec.|Least Square (LS) Mean Difference|4.8|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|1.3|8.3||||||2 hours post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||8.3|1.3|
71063912|NCT03187301|141636863|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% CIs for APL-130277 versus placebo fell below 10 msec.|Least Square (LS) Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|90.0|-1.7|5.3||||||3 hours post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||5.3|-1.7|
71063913|NCT03187301|141636863|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% CIs for APL-130277 versus placebo fell below 10 msec.|Least Sqaure (LS) Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.12||||90.0|-4.2|2.8||||||4 hours post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||2.8|-4.2|
71063914|NCT03187301|141636868|NON_INFERIORITY|15 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Difference|4.4|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|90.0|0.3|8.6||||||||8.6|0.3|
71063915|NCT03187301|141636868|NON_INFERIORITY|30 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|90.0|-1.6|6.7||||||||6.7|-1.6|
71063916|NCT03187301|141636868|NON_INFERIORITY|45 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|90.0|-0.9|7.4||||||||7.4|-0.9|
71063917|NCT03187301|141636868|NON_INFERIORITY|60 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|90.0|-0.9|7.5||||||||7.5|-0.9|
71063918|NCT03187301|141636868|NON_INFERIORITY|2 hours post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|90.0|0.8|9.2||||||||9.2|0.8|
71063919|NCT03187301|141636868|NON_INFERIORITY|3 hours post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Difference|4.6|STANDARD_ERROR_OF_MEAN|2.55|||TWO_SIDED|90.0|0.4|8.8||||||||8.8|0.4|
71063920|NCT03187301|141636868|NON_INFERIORITY|4 hours post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Differeence|2.6|STANDARD_ERROR_OF_MEAN|2.56|||TWO_SIDED|90.0|-1.6|6.9||||||||6.9|-1.6|
71078384|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-104.468|||||TWO_SIDED|95.0|-248.72|39.78|||||Day 7, 1 Hour|||39.78|-248.72|
71078385|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-118.462|||||TWO_SIDED|95.0|-263.93|27.01|||||Day 7, 1 Hour|||27.01|-263.93|
71078386|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-114.34|||||TWO_SIDED|95.0|-264.78|36.1|||||Day 7, 2 Hours|||36.10|-264.78|
70937645|NCT02978183|141375156|SUPERIORITY|||||||0.9981||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Pre-CAC||||0.9981
71063921|NCT03187301|141636872|NON_INFERIORITY|The hypothesis of assay sensitivity(difference in QTcF time between moxifloxacin and placebo)was evaluated by observing if any of the 4 post-dose evaluation time points had a one-sided(Bonferroni-corrected)95% lower confidence limit which was equal to, or exceeded, 5 msec.|Least Square (LS) Mean Difference|10.0|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|5.3|14.8||||||60 mins post-dose: time-matched, baseline-corrected comparison between moxifloxacin and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||14.8|5.3|
71063922|NCT03187301|141636872|NON_INFERIORITY|The hypothesis of assay sensitivity(difference in QTcF time between moxifloxacin and placebo)was evaluated by observing if any of the 4 post-dose evaluation time points had a one-sided(Bonferroni-corrected)95% lower confidence limit which was equal to, or exceeded, 5 msec.|Least Square (LS) Mean Difference|12.3|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|90.0|7.5|17.1||||||2 hours post-dose: time-matched, baseline-corrected comparison between moxifloxacin and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||17.1|7.5|
71063923|NCT03187301|141636872|NON_INFERIORITY|The hypothesis of assay sensitivity(difference in QTcF time between moxifloxacin and placebo)was evaluated by observing if any of the 4 post-dose evaluation time points had a one-sided(Bonferroni-corrected)95% lower confidence limit which was equal to, or exceeded, 5 msec.|Least Square (LS) Mean Difference|10.9|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|90.0|6.1|15.7||||||3 hours post-dose: time-matched, baseline-corrected comparison between moxifloxacin and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||15.7|6.1|
71063924|NCT03187301|141636872|NON_INFERIORITY|The hypothesis of assay sensitivity(difference in QTcF time between moxifloxacin and placebo)was evaluated by observing if any of the 4 post-dose evaluation time points had a one-sided(Bonferroni-corrected)95% lower confidence limit which was equal to, or exceeded, 5 msec.|Least Square (LS) Mean Difference|9.0|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|90.0|4.2|13.8||||||4 hours post-dose: time-matched, baseline-corrected comparison between moxifloxacin and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||13.8|4.2|
71063925|NCT02158585|141636880|SUPERIORITY||Mean Difference (Final Values)|8.93||||0.5618|TWO_SIDED|95.0|-3.49|21.35|||Wilcoxon (Mann-Whitney)|||Null hypothesis: no difference between groups in average total number of vertigo attacks||21.35|-3.49|0.5618
71063926|NCT02158585|141636881|SUPERIORITY|||||||0.03429|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: no difference between average total number of vertigo attacks in pre-treatment and treatment||||0.03429
71063927|NCT02158585|141636882|SUPERIORITY||Mean Difference (Net)|4.57||||0.0092|TWO_SIDED|95.0|0.85|8.29|||Wilcoxon (Mann-Whitney)|||Null hypothesis: no difference in total average number of vertigo attacks during 3 week time periods||8.29|0.85|0.0092
71111106|NCT01166347|141728427|SUPERIORITY||Difference in Percentages|1.1||||0.5922|TWO_SIDED|95.0|-8.5|10.8||If p\<0.05, then the test is statistically significant.|Regression, Logistic|Treatment as the only independent variable.|Difference = HeartWare - Control|If non-inferiority is established for the primary endpoint, statistical testing for superiority and p-value estimation for the 3 secondary endpoints (incidence of bleeding, incidence of major infection, overall survival) will be performed in a pre-specified sequence and testing will continue at the nominal alpha level until the first non-significant result. This fixed sequence procedure strongly controls the family-wise error rate for the collection of the 3 secondary endpoints.||10.8|-8.5|0.5922
71111107|NCT02891226|141728446|SUPERIORITY||Odds Ratio (OR)|2.75||||0.079|TWO_SIDED|90.0|1.07|7.08|||Regression, Logistic|||||7.08|1.07|0.079
70937646|NCT02978183|141375156|SUPERIORITY|||||||0.5645||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.5645
70937647|NCT02978183|141375156|SUPERIORITY|||||||0.5455||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.5455
71063928|NCT02158585|141636885|SUPERIORITY||Median Difference (Final Values)|11.14||||0.0385|TWO_SIDED|95.0|-15.64|37.92|||Wilcoxon (Mann-Whitney)|||||37.92|-15.64|0.0385
71063929|NCT04630002|141636927|OTHER||Ratio of geometric least square means|1.137|||||TWO_SIDED|90.0|0.999|1.293|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter AUC(0-tau).|||1.293|0.9990|
71111108|NCT02891226|141728446|SUPERIORITY||Odds Ratio (OR)|4.92||||0.003|TWO_SIDED|90.0|2.01|12.07|||Regression, Logistic|||||12.07|2.01|0.003
71111109|NCT02891226|141728446|SUPERIORITY||Odds Ratio (OR)|6.14|||<|0.001|TWO_SIDED|90.0|2.81|13.42|||Regression, Logistic|||||13.42|2.81|<0.001
71111110|NCT02891226|141728447|SUPERIORITY||Odds Ratio (OR)|4.31||||0.241|TWO_SIDED|90.0|0.55|33.58|||Regression, Logistic|||||33.58|0.55|0.241
70937648|NCT02978183|141375156|SUPERIORITY|||||||0.698||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.6980
70937649|NCT02978183|141375156|SUPERIORITY|||||||0.6115||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.6115
70937650|NCT02978183|141375156|SUPERIORITY|||||||0.4528||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.4528
71063930|NCT04630002|141636928|OTHER||Ratio of geometric least square means|1.068|||||TWO_SIDED|90.0|0.9185|1.242|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter Cmax.|||1.242|0.9185|
71063931|NCT04630002|141636929|OTHER||Ratio of geometric least square means|0.9891|||||TWO_SIDED|90.0|0.9313|1.051|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter AUC(0-tau).|||1.051|0.9313|
71063932|NCT04630002|141636930|OTHER||Ratio of geometric least square means|1.05|||||TWO_SIDED|90.0|0.9816|1.122|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter Cmax.|||1.122|0.9816|
71063933|NCT04630002|141636931|OTHER||Ratio of geometric least square means|1.102|||||TWO_SIDED|90.0|1.025|1.185|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter AUC(0-tau).|||1.185|1.025|
71111111|NCT02891226|141728447|SUPERIORITY||Odds Ratio (OR)|11.16||||0.032|TWO_SIDED|90.0|1.76|70.64|||Regression, Logistic|||||70.64|1.76|0.032
71063934|NCT04630002|141636932|OTHER||Ratio of geometric least square means|1.12|||||TWO_SIDED|90.0|0.9947|1.26|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter Cmax.|||1.260|0.9947|
71063935|NCT04630002|141636933|OTHER||Ratio of geometric least square means|0.5299|||||TWO_SIDED|90.0|0.4801|0.5848|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter AUC(0-tau).|||0.5848|0.4801|
70937651|NCT02978183|141375156|SUPERIORITY|||||||0.7551||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.7551
70937652|NCT02978183|141375156|SUPERIORITY|||||||0.5318||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.5318
70937653|NCT02978183|141375156|SUPERIORITY|||||||0.9748||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.9748
70937654|NCT02978183|141375156|SUPERIORITY|||||||0.7706||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.7706
70937655|NCT02978183|141375156|SUPERIORITY|||||||0.3414||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.3414
70937656|NCT02978183|141375156|SUPERIORITY|||||||0.4361||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.4361
70937657|NCT02978183|141375157|SUPERIORITY|||||||0.0603||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.0603
70937658|NCT02978183|141375157|SUPERIORITY|||||||0.4857||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 minutes Post-CAC||||0.4857
70937659|NCT02978183|141375157|SUPERIORITY|||||||0.9815||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.9815
71063936|NCT04630002|141636934|OTHER||Ratio of geometric least square means|0.6001|||||TWO_SIDED|90.0|0.5271|0.6833|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter Cmax.|||0.6833|0.5271|
71063937|NCT04630002|141636935|OTHER||Ratio of geometric least square means|1.144|||||TWO_SIDED|90.0|1.082|1.21|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter AUC(0-tau).|||1.210|1.082|
71063938|NCT04630002|141636936|OTHER||Ratio of geometric least square means|1.104|||||TWO_SIDED|90.0|1.026|1.187|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter Cmax.|||1.187|1.026|
71063939|NCT04630002|141636937|OTHER||Ratio of geometric least square means|0.9435|||||TWO_SIDED|90.0|0.8147|1.093|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter AUC(0-tau).|||1.093|0.8147|
71111112|NCT02891226|141728447|SUPERIORITY||Odds Ratio (OR)|16.04||||0.009|TWO_SIDED|90.0|2.82|91.32|||Regression, Logistic|||||91.32|2.82|0.009
71111113|NCT02891226|141728448|SUPERIORITY||Odds Ratio (OR)|2.0||||0.33|TWO_SIDED|90.0|0.62|6.45|||Regression, Logistic|||||6.45|0.62|0.330
71111114|NCT02891226|141728448|SUPERIORITY||Odds Ratio (OR)|5.72||||0.006|TWO_SIDED|90.0|2.02|16.21|||Regression, Logistic|||||16.21|2.02|0.006
71111115|NCT02891226|141728448|SUPERIORITY||Odds Ratio (OR)|3.52||||0.029|TWO_SIDED|90.0|1.37|9.07|||Regression, Logistic|||||9.07|1.37|0.029
71111116|NCT02891226|141728449|SUPERIORITY||LS Mean difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.234||0.007|TWO_SIDED|90.0|-1.03|-0.25|||Mixed Models Analysis|||||-0.25|-1.03|0.007
71111117|NCT02891226|141728449|SUPERIORITY||LS Mean difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|90.0|-1.21|-0.45|||Mixed Models Analysis|||||-0.45|-1.21|<0.001
71111118|NCT02891226|141728449|SUPERIORITY||LS Mean difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.188||0.005|TWO_SIDED|90.0|-0.84|-0.22|||Mixed Models Analysis|||||-0.22|-0.84|0.005
71111119|NCT02891226|141728451|SUPERIORITY||LS Mean difference (Final Values)|24.05|STANDARD_ERROR_OF_MEAN|6.358|<|0.001|TWO_SIDED|90.0|13.53|34.56|||Mixed Models Analysis|||||34.56|13.53|<0.001
71111120|NCT02891226|141728451|SUPERIORITY||LS Mean difference (Final Values)|29.46|STANDARD_ERROR_OF_MEAN|6.421|<|0.001|TWO_SIDED|90.0|18.84|40.08|||Mixed Models Analysis|||||40.08|18.84|<0.001
71111121|NCT02891226|141728451|SUPERIORITY||LS Mean difference (Final Values)|25.24|STANDARD_ERROR_OF_MEAN|5.185|<|0.001|TWO_SIDED|90.0|16.67|33.82|||Mixed Models Analysis|||||33.82|16.67|<0.001
71111122|NCT02891226|141728452|SUPERIORITY||LS Mean difference (Final Values)|7.91|STANDARD_ERROR_OF_MEAN|2.072|<|0.001|TWO_SIDED|90.0|4.48|11.34|||Mixed Models Analysis|||||11.34|4.48|<0.001
71111123|NCT02891226|141728452|SUPERIORITY||LS Mean difference (Final Values)|6.2|STANDARD_ERROR_OF_MEAN|2.102||0.004|TWO_SIDED|90.0|2.72|9.67|||Mixed Models Analysis|||||9.67|2.72|0.004
71111124|NCT02891226|141728452|SUPERIORITY||LS Mean difference (Final Values)|6.73|STANDARD_ERROR_OF_MEAN|1.686|<|0.001|TWO_SIDED|90.0|3.94|9.51|||Mixed Models Analysis|||||9.51|3.94|<0.001
71111125|NCT02891226|141728453|SUPERIORITY||LS Mean difference (Final Values)|5.14|STANDARD_ERROR_OF_MEAN|1.927||0.008|TWO_SIDED|90.0|1.95|8.32|||Mixed Models Analysis|||Mental Component Summary (MCS)||8.32|1.95|0.008
71111126|NCT02891226|141728453|SUPERIORITY||LS Mean difference (Final Values)|4.18|STANDARD_ERROR_OF_MEAN|1.951||0.033|TWO_SIDED|90.0|0.96|7.41|||Mixed Models Analysis|||Mental Component Summary (MCS)||7.41|0.96|0.033
71111127|NCT02891226|141728453|SUPERIORITY||LS Mean difference (Final Values)|3.71|STANDARD_ERROR_OF_MEAN|1.589||0.021|TWO_SIDED|90.0|1.08|6.34|||Mixed Models Analysis|||Mental Component Summary (MCS)||6.34|1.08|0.021
71111128|NCT02891226|141728453|SUPERIORITY||LS Mean difference (Final Values)|1.59|STANDARD_ERROR_OF_MEAN|1.319||0.229|TWO_SIDED|90.0|-0.59|3.77|||Mixed Models Analysis|||Physical Component Summary (PCS)||3.77|-0.59|0.229
71111129|NCT02891226|141728453|SUPERIORITY||LS Mean difference (Final Values)|4.91|STANDARD_ERROR_OF_MEAN|1.349|<|0.001|TWO_SIDED|90.0|2.67|7.14|||Mixed Models Analysis|||Physical Component Summary (PCS)||7.14|2.67|<0.001
71111130|NCT02891226|141728453|SUPERIORITY||LS Mean difference (Final Values)|3.6|STANDARD_ERROR_OF_MEAN|1.078||0.001|TWO_SIDED|90.0|1.81|5.38|||Mixed Models Analysis|||Physical Component Summary (PCS)||5.38|1.81|0.001
71111131|NCT00145626|141728463|SUPERIORITY_OR_OTHER||Cumulative Incidence|0.214|STANDARD_ERROR_OF_MEAN|0.114|||TWO_SIDED||||||||The cumulative incidence estimate and its standard error for occurrence of regimen-related mortality by the end of the first 100 days post-transplant was calculated.|||||
71111132|NCT03533660|141728553|SUPERIORITY||||||<|0.05||||||Applies to SOCRATES subscales recognition, ambivalence, taking steps at 6 weeks|t-test, 2 sided|||||||<.05
71111133|NCT03533660|141728553|SUPERIORITY||||||>|0.05||||||Applies to SOCRATES total scores and subscales (recognition, ambivalence, and taking steps) at intake and 3 months|t-test, 2 sided|||||||>.05
71111134|NCT03533660|141728554|SUPERIORITY||||||>|0.05||||||Applies to alcohol self-efficacy scale total score and subscales scores at intake, 6 weeks and 3 months|t-test, 2 sided|||||||>.05
71111135|NCT00996658|141728557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.0001||95.0|-0.83|-0.31|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and centre||||-0.31|-0.83|< 0.0001
71111136|NCT00996658|141728558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|||<|0.0001||95.0|-0.61|-0.21|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and centre||||-0.21|-0.61|< 0.0001
71111137|NCT00996658|141728559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.0001||95.0|-0.79|-0.28|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and centre||||-0.28|-0.79|< 0.0001
71111138|NCT00996658|141728560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.0001||95.0|-0.8|-0.29|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and centre||||-0.29|-0.80|< 0.0001
71111139|NCT00996658|141728561|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.939||||0.0033|TWO_SIDED|95.0|1.432|6.032|||Regression, Logistic|||Linagliptin vs Placebo||6.032|1.432|0.0033
71111140|NCT00996658|141728562|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.902||||0.0074|TWO_SIDED|95.0|1.44|10.572|||Regression, Logistic|||Linagliptin vs Placebo||10.572|1.440|0.0074
71111141|NCT00996658|141728563|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.059||||0.0071|TWO_SIDED|95.0|1.216|3.485|||Regression, Logistic|||Linagliptin vs. Placebo||3.485|1.216|0.0071
71111142|NCT00996658|141728564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4||||0.028||95.0|-19.6|-1.1|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline FPG, and centre||||-1.1|-19.6|0.0280
71111143|NCT00996658|141728565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.7||||0.0006||95.0|-24.5|-6.8|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline FPG, and centre||||-6.8|-24.5|0.0006
71111144|NCT00996658|141728566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9||||0.021||95.0|-20.2|-1.7|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline FPG, and centre||||-1.7|-20.2|0.0210
71111145|NCT00996658|141728567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.2||||0.2137||95.0|-16.0|3.6|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline FPG, and centre||||3.6|-16.0|0.2137
71111146|NCT04446312|141728579|NON_INFERIORITY|The pre-defined non-inferiority margin was 10%.|Risk Difference (RD)|0.15|||<|0.001|TWO_SIDED|95.0|-3.97|4.27|||Mantel Haenszel|||||4.27|-3.97|<0.001
71111147|NCT00200967|141728608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|7.0||0.99||95.0|-14.0|14.0|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for AM PEF rate.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design. A sample size of 40 participants per genotype was required to detect a difference of 25 L/min in AM PEF (and relevant effect sizes for secondary outcomes) with a two-sided, 0.05 significance level test with 90% statistical power and a 15% drop-out rate.||14|-14|0.99
70937660|NCT02978183|141375157|SUPERIORITY|||||||0.6213||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.6213
71063940|NCT04630002|141636938|OTHER||Ratio of geometric least square means|0.8928|||||TWO_SIDED|90.0|0.7467|1.068|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter Cmax.|||1.068|0.7467|
71063941|NCT00442897|141636986|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.714||||||95.0|1.77|7.78|||||Odds ratio was adjusted by baseline LDL strata.|||7.78|1.77|
71063942|NCT00442897|141636987|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.579||||||95.0|1.32|5.06|||||Odds ratio was adjusted by baseline LDL strata.|||5.06|1.32|
71063943|NCT04498182|141636988|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|2.81||0.2305|TWO_SIDED|95.0|-8.9|2.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||2.2|-8.9|0.2305
71063944|NCT04498182|141636988|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|2.81||0.7436|TWO_SIDED|95.0|-4.6|6.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.4|-4.6|0.7436
71063945|NCT04498182|141636989|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.7||0.4936|TWO_SIDED|95.0|-1.9|0.9|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.9|-1.9|0.4936
71063946|NCT04498182|141636989|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.7||0.7131|TWO_SIDED|95.0|-1.1|1.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.6|-1.1|0.7131
71063947|NCT04498182|141636990|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|2.81||0.2305|TWO_SIDED|95.0|-8.9|2.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||2.2|-8.9|0.2305
71063948|NCT04498182|141636990|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|2.81||0.7436|TWO_SIDED|95.0|-4.6|6.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.4|-4.6|0.7436
71063949|NCT04498182|141636991|SUPERIORITY||LS Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|3.17||0.0281|TWO_SIDED|95.0|-13.2|-0.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-0.8|-13.2|0.0281
71063950|NCT04498182|141636991|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|3.18||0.9186|TWO_SIDED|95.0|-5.9|6.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.6|-5.9|0.9186
71063951|NCT04498182|141636992|SUPERIORITY||LS Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|3.17||0.0281|TWO_SIDED|95.0|-13.2|-0.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-0.8|-13.2|0.0281
70852588|NCT04672954|141194070|OTHER||Ratio|1.66||||0.1089|TWO_SIDED|90.0|0.99|2.79|||ANCOVA||Ratio = BI / Placebo. Geometric standard error = 1.35|The difference between the expected means for ln(T) - ln(R) was estimated by the difference in the corresponding least square means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were back-transformed to the original scale to give the point estimator and interval estimates.||2.79|0.99|0.1089
70937661|NCT02978183|141375157|SUPERIORITY|||||||0.1831||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.1831
70937662|NCT02978183|141375157|SUPERIORITY|||||||0.6489||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.6489
71063952|NCT04498182|141636992|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|3.18||0.9186|TWO_SIDED|95.0|-5.9|6.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.6|-5.9|0.9186
71063953|NCT04498182|141636993|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.75||0.9846|TWO_SIDED|95.0|-1.5|1.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.5|-1.5|0.9846
71063954|NCT04498182|141636993|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.75||0.6508|TWO_SIDED|95.0|-1.1|1.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.8|-1.1|0.6508
71063955|NCT04498182|141636994|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.75||0.9846|TWO_SIDED|95.0|-1.5|1.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.5|-1.5|0.9846
71063956|NCT04498182|141636994|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.75||0.6508|TWO_SIDED|95.0|-1.1|1.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.8|-1.1|0.6508
71063957|NCT04498182|141636995|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.7||0.4936|TWO_SIDED|95.0|-1.9|0.9|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.9|-1.9|0.4936
71063958|NCT04498182|141636995|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.7||0.7131|TWO_SIDED|95.0|-1.1|1.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.6|-1.1|0.7131
71063959|NCT04498182|141636996|SUPERIORITY||LS Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|3.38||0.0786|TWO_SIDED|95.0|-12.6|0.7|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.7|-12.6|0.0786
71063960|NCT04498182|141636996|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|3.39||0.9477|TWO_SIDED|95.0|-6.9|6.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.5|-6.9|0.9477
71063961|NCT04498182|141636997|SUPERIORITY||LS Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|3.38||0.0786|TWO_SIDED|95.0|-12.6|0.7|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.7|-12.6|0.0786
70937663|NCT02978183|141375157|SUPERIORITY|||||||0.2622||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.2622
70937664|NCT02978183|141375157|SUPERIORITY|||||||0.2397||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.2397
70937665|NCT02978183|141375157|SUPERIORITY|||||||0.3202||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.3202
71063962|NCT04498182|141636997|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|3.39||0.9477|TWO_SIDED|95.0|-6.9|6.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.5|-6.9|0.9477
71111148|NCT00200967|141728609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|7.0||0.82||95.0|-15.0|12.0|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for PM PEF rate.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||12|-15|0.82
71111149|NCT00200967|141728610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.5||0.31||95.0|-1.6|0.5|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for PEF variability.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||0.5|-1.6|0.31
71111150|NCT00200967|141728611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.09||95.0|-0.02|0.07|||Wilcoxon (Mann-Whitney)||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for asthma symptoms.|A mixed-effects linear model was attempted but could not converge because very few symptoms were recorded, so a nonparametric analysis was applied.||0.07|-0.02|0.09
71063963|NCT04498182|141636998|SUPERIORITY||LS Means Difference|-5.0|STANDARD_ERROR_OF_MEAN|3.16||0.1153|TWO_SIDED|95.0|-11.2|1.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.2|-11.2|0.1153
71063964|NCT04498182|141636998|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|3.15||0.9975|TWO_SIDED|95.0|-6.2|6.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.2|-6.2|0.9975
71063965|NCT04498182|141636999|SUPERIORITY||LS Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|3.16||0.1153|TWO_SIDED|95.0|-11.2|1.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.2|-11.2|0.1153
71063966|NCT04498182|141636999|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|3.15||0.9975|TWO_SIDED|95.0|-6.2|6.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.2|-6.2|0.9975
71063967|NCT04498182|141637000|SUPERIORITY||LS Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|3.82||0.1518|TWO_SIDED|95.0|-13.0|2.0|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||2.0|-13.0|0.1518
71063968|NCT04498182|141637000|SUPERIORITY||LS Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|3.87||0.407|TWO_SIDED|95.0|-4.4|10.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||10.8|-4.4|0.4070
71063969|NCT04498182|141637001|SUPERIORITY||LS Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|3.82||0.1518|TWO_SIDED|95.0|-13.0|2.0|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||2.0|-13.0|0.1518
71063970|NCT04498182|141637001|SUPERIORITY||LS Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|3.87||0.407|TWO_SIDED|95.0|-4.4|10.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||10.8|-4.4|0.4070
71063971|NCT04498182|141637002|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|3.56||0.756|TWO_SIDED|95.0|-8.1|5.9|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||5.9|-8.1|0.7560
71063972|NCT04498182|141637002|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|3.62||0.8308|TWO_SIDED|95.0|-7.9|6.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.4|-7.9|0.8308
71063973|NCT04498182|141637003|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|3.56||0.756|TWO_SIDED|95.0|-8.1|5.9|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||5.9|-8.1|0.7560
71063974|NCT04498182|141637003|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|3.62||0.8308|TWO_SIDED|95.0|-7.9|6.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.4|-7.9|0.8308
71063975|NCT04498182|141637004|SUPERIORITY||LS Mean Difference|-7.9|STANDARD_ERROR_OF_MEAN|2.26||0.0005|TWO_SIDED|95.0|-12.4|-3.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-3.5|-12.4|0.0005
71111151|NCT00200967|141728612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.25||95.0|-0.1|0.2|||Wilcoxon (Mann-Whitney)||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for rescue medication use.|A mixed-effects linear model was attempted but could not converge because very few usages of rescue medications were recorded, so a nonparametric analysis was applied.||0.2|-0.1|0.25
71111152|NCT00200967|141728613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.34||95.0|-0.1|0.03|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for Spirometry FEV1, pre-bronchodilator.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||0.03|-0.10|0.34
71063976|NCT04498182|141637004|SUPERIORITY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|2.26||0.0585|TWO_SIDED|95.0|-8.7|0.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.2|-8.7|0.0585
70852589|NCT04672954|141194070|OTHER||Ratio|1.14||||0.6308|TWO_SIDED|90.0|0.71|1.85|||ANCOVA||Ratio = BI / Placebo. Geometric standard error = 1.32|The difference between the expected means for ln(T) - ln(R) was estimated by the difference in the corresponding least square means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were back-transformed to the original scale to give the point estimator and interval estimates.||1.85|0.71|0.6308
70852590|NCT04672954|141194070|OTHER||Ratio|1.75||||0.069|TWO_SIDED|90.0|1.06|2.89|||ANCOVA||Ratio = BI / Placebo. Geometric standard error = 1.33|The difference between the expected means for ln(T) - ln(R) was estimated by the difference in the corresponding least square means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were back-transformed to the original scale to give the point estimator and interval estimates.||2.89|1.06|0.0690
71063977|NCT04498182|141637005|SUPERIORITY||LS Mean Difference|-7.9|STANDARD_ERROR_OF_MEAN|2.26||0.0005|TWO_SIDED|95.0|-12.4|-3.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-3.5|-12.4|0.0005
71063978|NCT04498182|141637005|SUPERIORITY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|2.26||0.0585|TWO_SIDED|95.0|-8.7|0.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.2|-8.7|0.0585
70852591|NCT02617485|141194083|EQUIVALENCE|Equivalence met if the 90% CI of the Geo LS Means ratio is contained with the pre-specified equivalence margin of 70% - 143%.|Ratio of Geo LS-means|1.0406|||||TWO_SIDED|90.0|0.9565|1.1321||||||Estimated Geo LS-means ratio.||1.1321|0.9565|
70852592|NCT02617485|141194084|EQUIVALENCE|Equivalence met if the 90% CI of the Geo LS Means ratio is contained with the pre-specified equivalence margin of 70% - 143%.|Ratio of Geo LS-means|1.0611|||||TWO_SIDED|90.0|0.9822|1.1464||||||Estimated Geo LS-means ratio.||1.1464|0.9822|
71063979|NCT04498182|141637006|SUPERIORITY||LS Mean Difference|-8.9|STANDARD_ERROR_OF_MEAN|2.77||0.0015|TWO_SIDED|95.0|-14.3|-3.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-3.4|-14.3|0.0015
71063980|NCT04498182|141637006|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.78||0.6812|TWO_SIDED|95.0|-6.6|4.3|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||4.3|-6.6|0.6812
71078387|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-116.462|||||TWO_SIDED|95.0|-266.9|33.98|||||Day 7, 2 Hours|||33.98|-266.90|
70937666|NCT02978183|141375157|SUPERIORITY|||||||0.2663||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.2663
70937667|NCT02978183|141375157|SUPERIORITY|||||||0.5672||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.5672
70937668|NCT02978183|141375157|SUPERIORITY|||||||0.5055||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.5055
70937669|NCT02978183|141375157|SUPERIORITY|||||||0.8143||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.8143
70937670|NCT02978183|141375157|SUPERIORITY|||||||0.6901||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.6901
71063981|NCT04498182|141637007|SUPERIORITY||LS Mean Difference|-8.9|STANDARD_ERROR_OF_MEAN|2.77||0.0015|TWO_SIDED|95.0|-14.3|-3.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-3.4|-14.3|0.0015
71063982|NCT04498182|141637007|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.78||0.6812|TWO_SIDED|95.0|-6.6|4.3|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||4.3|-6.6|0.6812
71063983|NCT04498182|141637008|SUPERIORITY||LS Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|2.5||0.152|TWO_SIDED|95.0|-8.5|1.3|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.3|-8.5|0.1520
71063984|NCT04498182|141637008|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|2.49||0.8515|TWO_SIDED|95.0|-5.4|4.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||4.4|-5.4|0.8515
71063985|NCT04498182|141637009|SUPERIORITY||LS Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|2.5||0.152|TWO_SIDED|95.0|-8.5|1.3|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.3|-8.5|0.1520
71063986|NCT04498182|141637009|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|2.49||0.8515|TWO_SIDED|95.0|-5.4|4.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||4.4|-5.4|0.8515
71063987|NCT04498182|141637010|SUPERIORITY||LS Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|2.91||0.0302|TWO_SIDED|95.0|-12.1|-0.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-0.6|-12.1|0.0302
71063988|NCT04498182|141637010|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.92||0.8013|TWO_SIDED|95.0|-6.5|5.0|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||5.0|-6.5|0.8013
71063989|NCT04498182|141637011|SUPERIORITY||LS Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|2.91||0.0302|TWO_SIDED|95.0|-12.1|-0.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-0.6|-12.1|0.0302
71063990|NCT04498182|141637011|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.92||0.8013|TWO_SIDED|95.0|-6.5|5.0|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||5.0|-6.5|0.8013
71063991|NCT04498182|141637012|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|2.52||0.8166|TWO_SIDED|95.0|-4.4|5.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||5.5|-4.4|0.8166
71063992|NCT04498182|141637012|SUPERIORITY||LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|2.52||0.3371|TWO_SIDED|95.0|-2.5|7.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||7.4|-2.5|0.3371
71063993|NCT04498182|141637013|SUPERIORITY|||||||0.3365|||||||Wilcoxon (Mann-Whitney)|||||||0.3365
71063994|NCT04498182|141637013|SUPERIORITY|||||||0.7323|||||||Wilcoxon (Mann-Whitney)|||||||0.7323
71063995|NCT04498182|141637014|SUPERIORITY|||||||0.1557|||||||Wilcoxon (Mann-Whitney)|||||||0.1557
71063996|NCT04498182|141637014|SUPERIORITY|||||||0.6845|||||||Wilcoxon (Mann-Whitney)|||||||0.6845
71063997|NCT04498182|141637015|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|2.52||0.8166|TWO_SIDED|95.0|-4.4|5.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||5.5|-4.4|0.8166
71063998|NCT04498182|141637015|SUPERIORITY|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|2.52||0.3371|TWO_SIDED|95.0|-2.5|7.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||7.4|-2.5|0.3371
71063999|NCT04498182|141637016|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|2.81||0.5215|TWO_SIDED|95.0|-3.7|7.3|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||7.3|-3.7|0.5215
70937671|NCT02978183|141375158|SUPERIORITY|||||||0.4032||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.4032
70937672|NCT02978183|141375158|SUPERIORITY|||||||0.2946||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Post-CAC||||0.2946
70937673|NCT02978183|141375158|SUPERIORITY|||||||0.2863||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.2863
70937674|NCT02978183|141375158|SUPERIORITY|||||||0.0891||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.0891
71064000|NCT04498182|141637016|SUPERIORITY||LS Mean Difference|4.2|STANDARD_ERROR_OF_MEAN|2.81||0.1312|TWO_SIDED|95.0|-1.3|9.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||9.8|-1.3|0.1312
71064001|NCT04498182|141637017|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|2.81||0.5215|TWO_SIDED|95.0|-3.7|7.3|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||7.3|-3.7|0.5215
71064002|NCT04498182|141637017|SUPERIORITY||LS Mean Difference|4.2|STANDARD_ERROR_OF_MEAN|2.81||0.1312|TWO_SIDED|95.0|-1.3|9.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||9.8|-1.3|0.1312
71064003|NCT04498182|141637018|SUPERIORITY||LS Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.99||0.0254|TWO_SIDED|95.0|-8.4|-0.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-0.6|-8.4|0.0254
71064004|NCT04498182|141637018|SUPERIORITY||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.99||0.1362|TWO_SIDED|95.0|-6.9|0.9|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.9|-6.9|0.1362
71064005|NCT04498182|141637019|SUPERIORITY||LS Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.99||0.0254|TWO_SIDED|95.0|-8.4|-0.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-0.6|-8.4|0.0254
71064006|NCT04498182|141637019|SUPERIORITY||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.99||0.1362|TWO_SIDED|95.0|-6.9|0.9|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.9|-6.9|0.1362
71078388|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.201|||||TWO_SIDED|95.0|-154.75|146.35|||||Day 7, 2 Hours|||146.35|-154.75|
71064007|NCT04498182|141637020|SUPERIORITY||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|2.06||0.0573|TWO_SIDED|95.0|-8.0|0.1|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.1|-8.0|0.0573
71064008|NCT04498182|141637020|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|2.06||0.993|TWO_SIDED|95.0|-4.0|4.1|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||4.1|-4.0|0.9930
71064009|NCT04498182|141637021|SUPERIORITY||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|2.06||0.0573|TWO_SIDED|95.0|-8.0|0.1|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.1|-8.0|0.0573
71064010|NCT04498182|141637021|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|2.06||0.993|TWO_SIDED|95.0|-4.0|4.1|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||4.1|-4.0|0.9930
71064011|NCT04498182|141637022|SUPERIORITY||Odds Ratio (OR)|1.48||||0.3068|TWO_SIDED|95.0|0.7|3.15|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||3.15|0.70|0.3068
71064012|NCT04498182|141637022|SUPERIORITY||Odds Ratio (OR)|1.22||||0.6167|TWO_SIDED|95.0|0.56|2.68|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||2.68|0.56|0.6167
71064013|NCT04498182|141637023|SUPERIORITY||Odds Ratio (OR)|0.64||||0.2867|TWO_SIDED|95.0|0.28|1.46|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||1.46|0.28|0.2867
71064014|NCT04498182|141637023|SUPERIORITY||Odds Ratio (OR)|0.7||||0.3803|TWO_SIDED|95.0|0.32|1.57|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||1.57|0.32|0.3803
71064015|NCT04498182|141637024|SUPERIORITY||Odds Ratio (OR)|1.44||||0.4375|TWO_SIDED|95.0|0.58|3.58|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||3.58|0.58|0.4375
71064016|NCT04498182|141637024|SUPERIORITY||Odds Ratio (OR)|1.3||||0.584|TWO_SIDED|95.0|0.51|3.27|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||3.27|0.51|0.5840
71064017|NCT04498182|141637025|SUPERIORITY||Odds Ratio (OR)|0.73||||0.5046|TWO_SIDED|95.0|0.29|1.84|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||1.84|0.29|0.5046
71064018|NCT04498182|141637025|SUPERIORITY||Odds Ratio (OR)|1.27||||0.5751|TWO_SIDED|95.0|0.56|2.88|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||2.88|0.56|0.5751
71064019|NCT02375971|141637047|SUPERIORITY|The primary efficacy variable was treatment success, defined as the absence of active ROP and absence of unfavorable structural outcomes in both eyes 24 weeks after starting study treatment.|Odds Ratio (OR)|2.19||||0.0254|TWO_SIDED|95.0|0.9932|4.8235|||Cochran-Mantel-Haenszel|||||4.8235|0.9932|0.0254
71064020|NCT02667704|141637059|SUPERIORITY_OR_OTHER||Ratio of geometric means in percentage|98.85|STANDARD_DEVIATION|11.4|||TWO_SIDED|90.0|91.32|107.01|||ANOVA||Relative bioavailability was estimated by the ratio (T/R) of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient of variation.|Analysis of variance (ANOVA) model on the log scale including treatment as fixed effect and subject as a random effect||107.010|91.320|
71064021|NCT02667704|141637060|SUPERIORITY_OR_OTHER||Ratio of geometric means in percentage|103.36|STANDARD_DEVIATION|26.5|||TWO_SIDED|90.0|86.134|124.025|||ANOVA||Relative bioavailability was estimated by the ratio (T/R) of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient of variation.|Analysis of variance (ANOVA) model on the log scale including treatment as fixed effect and subject as a random effect||124.025|86.134|
71064022|NCT02667704|141637061|SUPERIORITY_OR_OTHER||Ratio of geometric means in percentage|101.98|STANDARD_DEVIATION|10.3|||TWO_SIDED|90.0|94.909|109.57|||ANOVA||Relative bioavailability was estimated by the ratio (T/R) of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient of variation.|Analysis of variance (ANOVA) model on the log scale including treatment as fixed effect and subject as a random effect||109.570|94.909|
71064023|NCT00832455|141637062|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||McNemar|||||||<0.001
71064024|NCT00832455|141637062|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||McNemar|||||||<0.001
71064025|NCT00832455|141637064|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||McNemar-Bowker|The McNemar-Bowker test is a statistical procedure used to compare the proportion of physician satisfaction at week 0 compared to week 12.||||||<0.001
71064026|NCT00832455|141637064|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||McNemar-Bowker|The McNemar-Bowker test is a statistical procedure used to compare the proportion of physician satisfaction at week 0 compared to week 8.||||||<0.001
71064027|NCT00832455|141637065|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||McNemar-Bowker|The McNemar-Bowker test is a statistical procedure used to compare the proportion of patient satisfaction at week 0 compared to week 12.||||||<0.001
71064028|NCT00832455|141637066|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 2 sided|Change in PACQLQ score between Week 12 and baseline is statistically different than zero||||||<0.001
71064029|NCT02275819|141637067|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||.14
71064030|NCT02275819|141637068|SUPERIORITY|||||||0.22|||||||t-test, 2 sided|||||||.22
71064031|NCT02275819|141637069|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||||||.12
71064032|NCT02275819|141637070|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||.08
71064033|NCT02275819|141637071|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||||||0.43
71078389|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-48.27|||||TWO_SIDED|95.0|-198.7|102.16|||||Day 7, 2 Hours|||102.16|-198.70|
71078390|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-50.605|||||TWO_SIDED|95.0|-202.31|101.1|||||Day 7, 2 Hours|||101.10|-202.31|
71078391|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.231|||||TWO_SIDED|95.0|-40.84|26.38|||||Day 7, 4 Hours|||26.38|-40.84|
71064034|NCT00343044|141637075|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED|||||Standard statistical methods (log-rank tests) were used in post hoc analyses that compared efficacy parameters in patients who received 1 vs 2 prior treatment regimens.|Log Rank|||Planned enrollment of 40 patients was determined assuming a median progression free survival (PFS) of 9 months (based on a median PFS of 7.2 months for low-dose, metronomic cyclophosphamide plus bevacizumab in a phase 2 study) and an analysis calculating the sample size at which the narrowing of its 95% confidence interval (CI) became greater than .2 for every 2 patients added. Progression free survival was estimated using the Kaplan-Meier method.||||.08
71064035|NCT00343044|141637076|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Standard statistical methods (log-rank tests) were used in post hoc analyses that compared efficacy parameters in patients who received 1 vs 2 prior treatment regimens.|Log Rank|||Overall survival(OS)was estimated using the Kaplan-Meier method.||||.02
71064036|NCT01575834|141637091|SUPERIORITY||Odds Ratio (OR)|0.27|||<|0.001|TWO_SIDED|95.0|0.15|0.47||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.|Values \< 1 for odds ratio favor romosozumab.|||0.47|0.15|< 0.001
71064037|NCT01575834|141637092|SUPERIORITY||Odds Ratio (OR)|0.24|||<|0.001|TWO_SIDED|95.0|0.15|0.39||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.|Values \< 1 for odds ratio favor romosozumab.|||0.39|0.15|< 0.001
71064038|NCT01575834|141637093|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.008|TWO_SIDED|95.0|0.46|0.89||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||0.89|0.46|0.008
71064039|NCT01575834|141637094|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.096|TWO_SIDED|95.0|0.53|1.05||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||1.05|0.53|0.096
70937675|NCT02978183|141375158|SUPERIORITY|||||||0.5347||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.5347
71064040|NCT01575834|141637095|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.057|TWO_SIDED|95.0|0.57|0.97||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||0.97|0.57|0.057
71064041|NCT01575834|141637096|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.096|TWO_SIDED|95.0|0.52|0.87||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||0.87|0.52|0.096
71064042|NCT01575834|141637097|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.096|TWO_SIDED|95.0|0.44|1.02||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||1.02|0.44|0.096
71064043|NCT01575834|141637098|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.096|TWO_SIDED|95.0|0.49|0.91||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab|||0.91|0.49|0.096
71064044|NCT01575834|141637099|SUPERIORITY||Odds Ratio (OR)|0.28||||0.096|TWO_SIDED|95.0|0.17|0.49||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.|Values \< 1 for odds ratio favor romosozumab.|||0.49|0.17|0.096
71064045|NCT01575834|141637100|SUPERIORITY||Odds Ratio (OR)|0.26||||0.096|TWO_SIDED|95.0|0.16|0.41||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test|Values \< 1 for odds ratio favor romosozumab.|||0.41|0.16|0.096
71064046|NCT01575834|141637101|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.18|TWO_SIDED|95.0|0.22|1.35||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||1.35|0.22|0.18
70937676|NCT02978183|141375158|SUPERIORITY|||||||0.3733||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.3733
70937677|NCT02978183|141375158|SUPERIORITY|||||||0.2506||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.2506
70937678|NCT02978183|141375158|SUPERIORITY|||||||0.8667||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.8667
70937679|NCT02978183|141375158|SUPERIORITY|||||||0.764||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.7640
70937680|NCT02978183|141375158|SUPERIORITY|||||||0.8008||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.8008
70937681|NCT02978183|141375158|SUPERIORITY|||||||0.4729||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.4729
70937682|NCT02978183|141375158|SUPERIORITY|||||||0.4742||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.4742
70937683|NCT02978183|141375158|SUPERIORITY|||||||0.2922||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.2922
70937684|NCT02978183|141375158|SUPERIORITY|||||||0.3657||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.3657
70937685|NCT02978183|141375159|SUPERIORITY|||||||0.66||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.6600
70937686|NCT02978183|141375159|SUPERIORITY|||||||0.6877||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 minutes Post-CAC||||0.6877
71064047|NCT01575834|141637102|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.12|TWO_SIDED|95.0|0.24|1.04||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||1.04|0.24|0.12
70937687|NCT02978183|141375159|SUPERIORITY|||||||0.334||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.3340
70937688|NCT02978183|141375159|SUPERIORITY|||||||0.7874||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.7874
71064048|NCT01575834|141637103|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.012|TWO_SIDED|95.0|0.4|0.9|||Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||0.90|0.40|0.012
70937689|NCT02978183|141375159|SUPERIORITY|||||||0.3812||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.3812
71064049|NCT01575834|141637104|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.002|TWO_SIDED|95.0|0.46|0.84|||Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||0.84|0.46|0.002
71064050|NCT01575834|141637105|SUPERIORITY||Odds Ratio (OR)|0.11||||0.011|TWO_SIDED|95.0|0.01|0.87|||Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.|Values \< 1 for odds ratio favor romosozumab.|||0.87|0.01|0.011
71064051|NCT01575834|141637106|SUPERIORITY||Odds Ratio (OR)|0.06|||<|0.001|TWO_SIDED|95.0|0.01|0.44|||Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.|Values \< 1 for odds ratio favor romosozumab.|||0.44|0.01|< 0.001
71064052|NCT01575834|141637107|SUPERIORITY||LS Mean Difference|12.7|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|12.4|12.9|||ANCOVA|||The treatment comparison of BMD at the lumbar spine was analyzed using an analysis of covariance (ANCOVA) model which included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.||12.9|12.4|< 0.001
70937690|NCT02978183|141375159|SUPERIORITY|||||||0.6987|||||||ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.6987
71078392|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.025|||||TWO_SIDED|95.0|-38.63|28.58|||||Day 7, 4 Hours|||28.58|-38.63|
70937691|NCT02978183|141375159|SUPERIORITY|||||||0.6832||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.6832
70937692|NCT02978183|141375159|SUPERIORITY|||||||0.8521||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.8521
70937693|NCT02978183|141375159|SUPERIORITY|||||||0.7516||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.7516
70937694|NCT02978183|141375159|SUPERIORITY|||||||0.6252||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.6252
70937695|NCT02978183|141375159|SUPERIORITY|||||||0.8321||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.8321
70937696|NCT02978183|141375159|SUPERIORITY|||||||0.8173||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.8173
70937697|NCT02978183|141375159|SUPERIORITY|||||||0.5445||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.5445
70937698|NCT02978183|141375159|SUPERIORITY|||||||0.681||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.6810
70937699|NCT02978183|141375160|SUPERIORITY|||||||0.0111||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.0111
70937700|NCT02978183|141375160|SUPERIORITY|||||||0.3391||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Post-CAC||||0.3391
70937701|NCT02978183|141375160|SUPERIORITY|||||||0.239||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.2390
70937702|NCT02978183|141375160|SUPERIORITY|||||||0.3068||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.3068
70937703|NCT02978183|141375160|SUPERIORITY|||||||0.4914||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.4914
70937704|NCT02978183|141375160|SUPERIORITY|||||||0.5185||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.5185
70937705|NCT02978183|141375160|SUPERIORITY|||||||0.5262||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.5262
70937706|NCT02978183|141375160|SUPERIORITY|||||||0.6098||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.6098
70937707|NCT02978183|141375160|SUPERIORITY|||||||0.8849||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.8849
70937708|NCT02978183|141375160|SUPERIORITY|||||||0.6941||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.6941
70937709|NCT02978183|141375160|SUPERIORITY|||||||0.5728||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.5728
70937710|NCT02978183|141375160|SUPERIORITY|||||||0.5931||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.5931
70937711|NCT02978183|141375160|SUPERIORITY|||||||0.7513||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.7513
70937712|NCT02978183|141375160|SUPERIORITY|||||||0.7297||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.7297
70937713|NCT02978183|141375161|SUPERIORITY|||||||0.1259||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.1259
70937714|NCT02978183|141375161|SUPERIORITY|||||||0.9234||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Post-CAC||||0.9234
70937715|NCT02978183|141375161|SUPERIORITY|||||||0.8816||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.8816
70937716|NCT02978183|141375161|SUPERIORITY|||||||0.5703||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.5703
70937717|NCT02978183|141375161|SUPERIORITY|||||||0.5428||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.5428
70937718|NCT02978183|141375161|SUPERIORITY|||||||0.7454||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.7454
70937719|NCT02978183|141375161|SUPERIORITY|||||||0.8195||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.8195
70937720|NCT02978183|141375161|SUPERIORITY|||||||0.0909||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.0909
71064053|NCT01575834|141637108|SUPERIORITY||LS Mean Difference|11.1|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|10.8|11.4|||ANCOVA|||The treatment comparison of BMD at the lumbar spine was analyzed using an analysis of covariance (ANCOVA) model which included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.||11.4|10.8|< 0.001
71064054|NCT01575834|141637109|SUPERIORITY||LS Mean Difference|5.8|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|5.6|6.0|||ANCOVA|||The treatment comparison of BMD at the total hip was analyzed using an ANCOVA model which included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.||6.0|5.6|< 0.001
71064055|NCT01575834|141637110|SUPERIORITY||LS Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|5.1|5.5|||ANCOVA|||The treatment comparison of BMD at the total hip was analyzed using an ANCOVA model which included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.||5.5|5.1|< 0.001
71064056|NCT01575834|141637111|SUPERIORITY||LS Mean Difference|5.2|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|4.9|5.4|||ANCOVA|||The treatment comparison of BMD at the femoral neck was analyzed using an ANCOVA model which included included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.||5.4|4.9|< 0.001
71064057|NCT01575834|141637112|SUPERIORITY||LS Mean Difference|4.9|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|4.7|5.2|||ANCOVA|||The treatment comparison of BMD at the femoral neck was analyzed using an ANCOVA model which included included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.||5.2|4.7|< 0.001
70937721|NCT02978183|141375161|SUPERIORITY|||||||0.4881||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.4881
70937722|NCT02978183|141375161|SUPERIORITY|||||||0.3391||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.3391
70937723|NCT02978183|141375161|SUPERIORITY|||||||0.6065||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.6065
71064058|NCT03858998|141637124|SUPERIORITY||Risk Difference (RD)|0.004||||0.91|TWO_SIDED|95.0|-0.06|0.07|||Chi-squared||Direction = Linkage minus SOC|||0.07|-0.06|0.91
71078393|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.523|||||TWO_SIDED|95.0|-24.11|43.16|||||Day 7, 4 Hours|||43.16|-24.11|
70937724|NCT02978183|141375161|SUPERIORITY|||||||0.3393||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.3393
70937725|NCT02978183|141375161|SUPERIORITY|||||||0.8364||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.8364
70937726|NCT02978183|141375161|SUPERIORITY|||||||0.8858||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.8858
70937727|NCT02978183|141375162|SUPERIORITY|||||||0.8818||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.8818
70937728|NCT02978183|141375162|SUPERIORITY|||||||0.8679||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 minutes Post-CAC||||0.8679
70937729|NCT02978183|141375162|SUPERIORITY|||||||0.7856||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.7856
70937730|NCT02978183|141375162|SUPERIORITY|||||||0.7507||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.7507
70937731|NCT02978183|141375162|SUPERIORITY|||||||0.8189||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.8189
70937732|NCT02978183|141375162|SUPERIORITY|||||||0.9206||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.9206
70937733|NCT02978183|141375162|SUPERIORITY|||||||0.9591||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.9591
70937734|NCT02978183|141375162|SUPERIORITY|||||||0.5302||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.5302
70937735|NCT02978183|141375162|SUPERIORITY|||||||0.7591||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.7591
70937736|NCT02978183|141375162|SUPERIORITY|||||||0.8978||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.8978
70937737|NCT02978183|141375162|SUPERIORITY|||||||0.7179||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.7179
70937738|NCT02978183|141375162|SUPERIORITY|||||||0.7262||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.7262
70937739|NCT02978183|141375162|SUPERIORITY|||||||0.8275||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.8275
70937740|NCT02978183|141375162|SUPERIORITY|||||||0.618||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.6180
71064059|NCT00720213|141637143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.98|STANDARD_DEVIATION|8.03||0.0054|TWO_SIDED|95.0|1.44|6.51|||Wilcoxon Signed Rank test|||Each participant was treated with the BiPAP autoSV2 (ASV2) and autoSV Advanced (ASV3) on two separate nights; therefore, the data were analyzed as paired samples. Depending on normality, each endpoint was analyzed with either a paired t-test or the nonparametric Wilcoxon Signed Ranks test. All comparisons were 2-sided conducted at a 5% level of significance.||6.51|1.44|0.0054
71064060|NCT00365794|141637171|OTHER|||||||0.77|||||||t-test, 2 sided|||Total body mass||||0.77
71064061|NCT00365794|141637171|OTHER|||||||0.003|||||||t-test, 2 sided|||Total fat mass||||0.003
71064062|NCT00365794|141637171|OTHER|||||||0.0007|||||||t-test, 2 sided|||Statistical analysis is for change in trunk fat mass after 20 weeks of testosterone gel.||||0.0007
71064063|NCT00365794|141637171|OTHER|||||||0.01|||||||t-test, 2 sided|||Statistical analysis is for change in extremity fat mass after 20 weeks of testosterone gel.||||0.01
71064064|NCT00365794|141637172|OTHER|||||||0.12||||||No adjustment in p for multiple comparisons.|t-test, 2 sided|||||||0.12
71064065|NCT00365794|141637173|OTHER|||||||0.008|||||||t-test, 2 sided|||||||0.008
71064066|NCT00365794|141637174|OTHER|||||||0.0002||||||No adjustment for multiple comparisons.|t-test, 2 sided|||||||0.0002
71064067|NCT00365794|141637175|OTHER|||||||0.04|||||||t-test, 2 sided|||Statistical analysis for change in whole body insulin sensitivity after treatment with testosterone gel for 20 weeks.||||0.04
71064068|NCT00365794|141637175|OTHER|||||||0.59|||||||t-test, 2 sided|||Statistical analysis for change in hepatic glucose output (measure of central insulin sensitivity) after treatment with testosterone gel for 20 weeks||||0.59
71064069|NCT00365794|141637175|OTHER|||||||0.03|||||||t-test, 2 sided|||Statistical analysis for change in rate of peripheral glucose disposal (test of peripheral insulin sensitivity) after treatment with testosterone gel for 20 weeks||||0.03
71064070|NCT00365794|141637176|OTHER|||||||0.0006|||||||t-test, 2 sided|||Change in DEXA extremity (appendicular) lean tissue, a measure of extremity muscle mass after 20 weeks ot treatent with testosterone gel.||||0.0006
71064071|NCT00365794|141637177|OTHER|Test for fasting triglycerides||||||0.02|||||||t-test, 2 sided|||A change in 20 plasma lipids (fasting triglycerides and lipid fractions) after 20 weeks of treatment with testosterone gel.||||0.02
71064072|NCT00365794|141637177|OTHER|Test for total cholesterol||||||0.004|||||||t-test, 2 sided|||A change in 20 plasma lipids (fasting triglycerides and lipid fractions) after 20 weeks of treatment with testosterone gel||||0.004
71064073|NCT00365794|141637177|OTHER|Test for LDL cholesterol||||||0.02|||||||t-test, 2 sided|||nts A change in 20 plasma lipids (fasting triglycerides and lipid fractions) after 20 weeks of treatment with testosterone gel||||.02
71064074|NCT00365794|141637177|OTHER|Test for HDL cholesterol||||||0.004|||||||t-test, 2 sided|||A change in 20 plasma lipids (fasting triglycerides and lipid fractions) after 20 weeks of treatment with testosterone gel||||0.004
71064075|NCT00365794|141637178|OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.06
71064076|NCT00365794|141637179|OTHER|||||||0.97|||||||t-test, 2 sided|||||||0.97
71064077|NCT00365794|141637180|OTHER|||||||0.83|||||||t-test, 2 sided|||||||0.83
71064078|NCT00745901|141637181|SUPERIORITY_OR_OTHER|||||||0.9698||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.9698
71064079|NCT00745901|141637182|SUPERIORITY_OR_OTHER|||||||0.0715||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0715
71064080|NCT00745901|141637183|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0050
71064081|NCT00745901|141637184|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0006
71064082|NCT00745901|141637185|SUPERIORITY_OR_OTHER|||||||0.0031||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0031
70937741|NCT02978183|141375163|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity were not employed|Fisher Exact|||Day 7: 10 minutes post-CAC||||>0.9999
70937742|NCT02978183|141375163|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 7: 15 minutes post-CAC||||>0.9999
71064083|NCT00745901|141637186|SUPERIORITY_OR_OTHER|||||||0.0013||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0013
71064084|NCT00745901|141637187|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71064085|NCT00745901|141637188|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71064086|NCT00745901|141637189|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71064087|NCT00745901|141637190|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71064088|NCT00745901|141637191|SUPERIORITY_OR_OTHER|||||||0.0033||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0033
71064089|NCT00745901|141637192|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0060
71064090|NCT00745901|141637193|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71064091|NCT00745901|141637194|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71064092|NCT00745901|141637195|SUPERIORITY_OR_OTHER|||||||0.912||95.0|||||Fisher Exact|||||||0.912
71064093|NCT00745901|141637196|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||||||0.003
71064094|NCT00745901|141637197|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Fisher Exact|||||||0.002
71064095|NCT00745901|141637198|SUPERIORITY_OR_OTHER|||||||0.816||95.0|||||Fisher Exact|||||||0.816
71064096|NCT00745901|141637199|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Fisher Exact|||||||0.012
71064097|NCT00745901|141637200|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||||||0.003
71064098|NCT00884117|141637211|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<0.0001
71064099|NCT00884117|141637211|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Pairwise Wilcoxon|||||||<0.01
71064100|NCT00884117|141637211|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Pairwise Wilcoxon|||||||<0.01
71064101|NCT00884117|141637212|SUPERIORITY_OR_OTHER|||||||0.015|||||||Kruskal-Wallis|||||||0.015
71064102|NCT00884117|141637212|SUPERIORITY_OR_OTHER|||||||0.009|||||||Pairwise Wilcoxon|||||||0.009
71064103|NCT00884117|141637212|SUPERIORITY_OR_OTHER|||||||0.03|||||||Pairwise Wilcoxon|||||||0.03
71064104|NCT00884117|141637213|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Kruskal-Wallis|||||||0.0005
71064105|NCT00884117|141637213|SUPERIORITY_OR_OTHER|||||||0.008|||||||Pairwise Wilcoxon|||||||0.008
71064106|NCT00884117|141637213|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Pairwise Wilcoxon|||||||<0.0001
71064107|NCT00884117|141637214|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Kruskal-Wallis|||||||0.0002
71064108|NCT00884117|141637214|SUPERIORITY_OR_OTHER|||||||0.008|||||||Pairwise Wilcoxon|||||||0.008
71064109|NCT00884117|141637214|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Pairwise Wilcoxon|||||||<0.0001
71064110|NCT00884117|141637217|SUPERIORITY_OR_OTHER|||||||0.4464|||||||Cochran-Mantel-Haenszel|||Resistant versus Susceptible||||0.4464
71064111|NCT00884117|141637218|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Resistant versus Susceptible||||<0.0001
71064112|NCT00884117|141637219|SUPERIORITY_OR_OTHER|||||||0.2499|||||||Cochran-Mantel-Haenszel|||Resistant versus Susceptible||||0.2499
71064113|NCT02712554|141637234|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71064114|NCT02712554|141637234|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71064115|NCT02712554|141637234|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2344|||||||ANOVA|||||||0.2344
71064116|NCT02712554|141637234|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4737|||||||ANOVA|||||||0.4737
71064117|NCT02712554|141637234|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71064118|NCT02712554|141637234|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71064119|NCT02712554|141637238|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo||||<.0001
71064120|NCT02712554|141637238|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo||||<.0001
71064121|NCT02712554|141637238|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1267|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.1267
71064122|NCT02712554|141637238|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1767|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.1767
71064123|NCT02712554|141637238|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo||||<.0001
71064124|NCT02712554|141637238|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo||||<.0001
71064125|NCT02712554|141637238|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0119|||||||ANOVA|||Emin: Treatment C (low-dose M366) - Placebo||||0.0119
71064126|NCT02712554|141637238|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0025|||||||ANOVA|||Emin: Treatment D (high-dose M366) - Placebo||||0.0025
71064127|NCT02712554|141637238|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1679|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.1679
71064128|NCT02712554|141637238|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0318|||||||ANOVA|||Emin: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.0318
71064129|NCT02712554|141637238|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Placebo||||0.0002
71064130|NCT02712554|141637238|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||||||<.0001
71064131|NCT02712554|141637239|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo||||<.0001
71064132|NCT02712554|141637239|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo||||<.0001
71064133|NCT02712554|141637239|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0858|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.0858
71064134|NCT02712554|141637239|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2877|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.2877
71064135|NCT02712554|141637239|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo||||<.0001
71064136|NCT02712554|141637239|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo||||<.0001
71064137|NCT02712554|141637239|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009|||||||ANOVA|||Emin: Treatment C (low-dose M366) - Placebo||||0.0009
71064138|NCT02712554|141637239|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||ANOVA|||Emin: Treatment D (high-dose M366) - Placebo||||0.0001
71064139|NCT02712554|141637239|SUPERIORITY_OR_OTHER_LEGACY|||||||0.113|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.1130
71064140|NCT02712554|141637239|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0575|||||||ANOVA|||Emin: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.0575
71064141|NCT02712554|141637239|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Placebo||||<.0001
71064142|NCT02712554|141637239|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emin: Treatment B (high-dose CL-108) - Placebo||||<.0001
71064143|NCT02712554|141637240|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo||||<.0001
71064144|NCT02712554|141637240|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo||||<.0001
71064145|NCT02712554|141637240|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4025|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.4025
71064146|NCT02712554|141637240|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3184|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.3184
71064147|NCT02712554|141637240|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo||||<.0001
71064148|NCT02712554|141637240|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo||||<.0001
71064149|NCT02712554|141637241|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment C (low-dose M366) - Placebo||||<.0001
70937743|NCT02978183|141375163|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 7: 20 minutes post-CAC||||>0.9999
71064150|NCT02712554|141637241|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment D (high-dose M366) - Placebo||||<.0001
71064151|NCT02712554|141637241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2628|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.2628
71064152|NCT02712554|141637241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2262|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.2262
71064153|NCT02712554|141637241|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo||||<.0001
71064154|NCT02712554|141637241|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo||||<.0001
71064155|NCT02712554|141637242|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo||||<.0001
71064156|NCT02712554|141637242|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo||||<.0001
70937744|NCT02978183|141375163|SUPERIORITY|||||||0.7312||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 7: 25 minutes post-CAC||||0.7312
70937745|NCT02978183|141375163|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 7: 30 minutes post-CAC||||>0.9999
71064157|NCT02712554|141637242|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1839|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.1839
71064158|NCT02712554|141637242|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1751|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.1751
71064159|NCT02712554|141637242|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo||||<.0001
71064160|NCT02712554|141637242|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo||||<.0001
71064161|NCT02712554|141637243|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment C (low-dose M366) - Placebo||||<.0001
71064162|NCT02712554|141637243|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment D (high-dose M366) - Placebo||||<.0001
71064163|NCT02712554|141637243|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4013|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.4013
71064164|NCT02712554|141637243|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0736|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.0736
71064165|NCT02712554|141637243|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo||||<.0001
71064166|NCT02712554|141637243|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo||||<.0001
71064167|NCT02712554|141637244|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo||||<0.001
71111153|NCT00200967|141728614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.91||95.0|-0.08|0.07|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for Spirometry FVC, pre-bronchodilator.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||0.07|-0.08|0.91
71111154|NCT00200967|141728615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|7.0||0.93||95.0|-15.0|14.0|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for Spirometry PEF rate, pre-bronchodilator.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||14|-15|0.93
71111155|NCT00200967|141728616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.08||0.13||95.0|-0.04|0.31|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for eNO.|A mixed-effects linear model was applied to the natural logarithm of eNO to account for the repeated measurements within each treatment period of the crossover design.||0.31|-0.04|0.13
71111156|NCT00200967|141728617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.24||0.79||95.0|-0.56|0.43|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for EBC.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||0.43|-0.56|0.79
71111157|NCT00200967|141728618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32|STANDARD_ERROR_OF_MEAN|0.45||0.004||95.0|0.43|2.21|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for methacholine PC20.|A mixed-effects linear model was applied to the base-2 logarithm of the methacholine PC20 to account for the repeated measurements within each treatment period of the crossover design.||2.21|0.43|0.004
71111158|NCT00200967|141728619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.12||0.89||95.0|-0.23|0.26|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for ACQ.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||0.26|-0.23|0.89
70937746|NCT02978183|141375163|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 8: 10 minutes post-CAC||||>0.9999
71064168|NCT02712554|141637244|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo||||<0.001
71064169|NCT02712554|141637244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2223|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.2223
71064170|NCT02712554|141637244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1638|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.1638
71064171|NCT02712554|141637244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0041|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo||||0.0041
71064172|NCT02712554|141637244|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo||||<0.001
71064173|NCT02712554|141637245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment C (low-dose M366) - Placebo||||0.0001
71064174|NCT02712554|141637245|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment D (high-dose M366) - Placebo||||<0.0001
71111159|NCT01444430|141728628|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the 95% CI of the hazard ratio will be used to assess statistical non-inferiority (non-inferiority margin=2).|Hazard Ratio (HR)|1.073|||||TWO_SIDED|95.0|0.698|1.65|||Regression, Cox|||||1.650|0.698|
71111160|NCT01444430|141728629|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.835||||0.002|TWO_SIDED|95.0|0.745|0.937|||Regression, Cox|||||0.937|0.745|0.002
71111161|NCT01444430|141728630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|3.3|5.4|||ANOVA|||||5.4|3.3|<0.001
71111162|NCT01444430|141728631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.6||0.272|TWO_SIDED|95.0|-0.5|1.7|||ANOVA|||||1.7|-0.5|0.272
71111163|NCT01444430|141728632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0|<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||ANOVA|||||-0.1|-0.2|<0.001
71111164|NCT01444430|141728633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|-0.1|-0.06|||ANCOVA|||||-0.06|-0.10|<0.001
71111165|NCT01444430|141728634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.004|TWO_SIDED|95.0|-1.0|-0.2|||ANOVA|||||-0.2|-1.0|0.004
71111166|NCT01444430|141728635|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.739||||0.095|TWO_SIDED|95.0|0.518|1.055|||Regression, Cox|||||1.055|0.518|0.095
71111167|NCT01061723|141728659|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.966|TWO_SIDED|95.0|0.4|2.5||Threshold for significance = 0.05|Cochran-Mantel-Haenszel|||Sarilumab group was compared to placebo group. Analysis was performed using two-sided Cochran-Mantel-Haenszel test. Pairwise comparisons of the response rates between each dose of sarilumab and placebo were derived.||2.5|0.4|0.966
71111168|NCT01061723|141728659|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.467|TWO_SIDED|95.0|0.6|3.5||Threshold for significance = 0.05|Cochran-Mantel-Haenszel|||||3.5|0.6|0.467
70937747|NCT02978183|141375163|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 8: 15 minutes post-CAC||||>0.9999
71064175|NCT02712554|141637245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2706|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.2706
71064176|NCT02712554|141637245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5507|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.5507
71064177|NCT02712554|141637245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0047|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo||||0.0047
71064178|NCT02712554|141637245|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo||||<0.0001
71064179|NCT02712554|141637246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||ANOVA|||Emin: Treatment C (low-dose M366) - Placebo||||0.0001
71064180|NCT02712554|141637246|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emin: Treatment D (high-dose M366) - Placebo||||<0.0001
70852593|NCT01248104|141194108|SUPERIORITY_OR_OTHER_LEGACY|Continuous variables were compared by multivariate linear regression analysis to adjust for possible covariates of intraoperative fluids, age, bypass time, and procedure time. Tukey-Kramer test was then used to compare for specific differences between groups for each variable. Categorical data were compared using Fisher's exact test. All comparisons were made at a significance level of 0.05, and analysis was performed with Minitab version 17).||||||0.35||||||The primary outcome measure showed that there was no difference in PRBC transfusion frequency or amounts in the operating room or the in ICU up to POD 2|ANOVA|||A power analysis based on the comparison of a 15% difference in total transfusion amounts up to POD 2 between the treatment groups indicated a total sample size of 80 with a power of 0.8, confidence interval 0.9, and p= 0.05.||||0.35
70852594|NCT01410357|141194133|SUPERIORITY|||||||0.785||||||Bonferroni corrections were conducted to adjust for multiple comparisons.|Mixed Models Analysis|||||||.785
70852595|NCT01410357|141194134|SUPERIORITY|||||||0.016|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.||||||.016
70852596|NCT01410357|141194135|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.||||||<0.001
70852597|NCT01410357|141194136|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.||||||.003
70852598|NCT01410357|141194137|SUPERIORITY|||||||0.086|||||||Mixed Models Analysis|||||||.086
70852599|NCT01410357|141194138|SUPERIORITY|||||||0.872|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.||||||.872
70852600|NCT01410357|141194139|SUPERIORITY|||||||0.662|||||||Mixed Models Analysis|||||||.662
70852601|NCT01410357|141194140|SUPERIORITY|||||||0.633|||||||Mixed Models Analysis|||||||.633
70852602|NCT01410357|141194141|SUPERIORITY|||||||0.175|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.||||||.175
70852603|NCT01410357|141194142|SUPERIORITY|||||||0.68|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.||||||.680
70852604|NCT01410357|141194143|SUPERIORITY|||||||0.407|||||||Mixed Models Analysis|||||||.407
70852605|NCT01410357|141194144|SUPERIORITY|||||||0.87|||||||Mixed Models Analysis|||||||.870
70852606|NCT01410357|141194145|SUPERIORITY|||||||0.707|||||||Mixed Models Analysis|||||||.707
71064181|NCT02712554|141637246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.0014
70852607|NCT01410357|141194146|SUPERIORITY|||||||0.838|||||||Mixed Models Analysis|||||||.838
70852608|NCT01410357|141194147|SUPERIORITY|||||||0.853|||||||Mixed Models Analysis|||||||.853
70852609|NCT01410357|141194148|SUPERIORITY|||||||0.853|||||||Mixed Models Analysis|||||||.853
70852610|NCT01410357|141194149|SUPERIORITY|||||||0.51|||||||Mixed Models Analysis|||||||.510
70852611|NCT01410357|141194150|SUPERIORITY|||||||0.573|||||||Mixed Models Analysis|||||||.573
70852612|NCT01410357|141194151|SUPERIORITY|||||||0.758|||||||Mixed Models Analysis|||||||.758
70852613|NCT01410357|141194152|SUPERIORITY|||||||0.156|||||||Mixed Models Analysis|||||||.156
70852614|NCT01410357|141194153|SUPERIORITY|||||||0.156|||||||Mixed Models Analysis|||||||.156
70852615|NCT01410357|141194154|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
70852616|NCT01410357|141194155|SUPERIORITY|||||||0.878|||||||Mixed Models Analysis|||||||.878
70852617|NCT01410357|141194156|SUPERIORITY|||||||0.014|||||||Mixed Models Analysis|||||||.014
70852618|NCT01410357|141194157|SUPERIORITY|||||||0.227|||||||Mixed Models Analysis|||||||.227
70852619|NCT01589653|141194164|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be considered confirmed if the upper bound of the two-sided 95% CI was below or equal to 0.4% or equivalently when the p-value for the one-sided test of H0: D \> 0.4% against HA: D ≤ 0.4%, was less than or equal to 2.5%, where D is the mean treatment difference (subject-driven titration minus investigator-driven titration).|Treatment difference|-0.23|||<|0.001|TWO_SIDED|95.0|-0.54|0.08|||Regression, Linear|Analyses were adjusted for treatment, strata, country and baseline HbA1c||The null-hypothesis was tested against the alternative hypothesis of non-inferiority as given by: H0: D \> 0.4% against HA: D ≤ 0.4% where D is the mean treatment difference for change in HbA1c (subject-driven titration minus investigator-driven titration).||0.08|-0.54|<0.001
70852620|NCT00505076|141194195|SUPERIORITY_OR_OTHER|||||||0.21|||||||ANCOVA|||An analysis of covariance (ANCOVA), adjusting for baseline scores, was used to compare treatment groups on cognitive and functional measures. The predefined primary cognition outcome measure was the MCCB (MATRICS (Measurement and Treatment Research to Improve Cognition in Schizophrenia Research) Consensus Cognitive Battery) composite T-score, tested at overall two-sided alpha=0.05.||||0.21
70852621|NCT00505076|141194196|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||ANCOVA|||The sample size was determined using the analysis of covariance power formula, n=2\[za+zβ\]2s2 (1-R2)/d2, with za=2.24, zβ=0.842 (corresponding to power=0.80), R=the correlation between baseline and end of study measures of the outcome, d the difference between groups, and s the standard deviation of the outcome. Actual recruitment was only about 20 participants per group, but the observed R≅0.9, suggesting power to detect an effect size of 0.49.||||0.47
70852622|NCT00505076|141194197|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||ANCOVA|||The sample size was determined using the analysis of covariance power formula, n=2\[za+zβ\]2s2 (1-R2)/d2, with za=2.24, zβ=0.842 (corresponding to power=0.80), R=the correlation between baseline and end of study measures of the outcome, d the difference between groups, and s the standard deviation of the outcome. Actual recruitment was only about 20 participants per group, but the observed R≅0.9, suggesting power to detect an effect size of 0.49.||||0.84
70937748|NCT02978183|141375163|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 8: 20 minutes post-CAC||||>0.9999
71064182|NCT02712554|141637246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|||||||ANOVA|||Emin: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.0080
71064183|NCT02712554|141637246|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Placebo||||<0.0001
70937749|NCT02978183|141375163|SUPERIORITY|||||||0.4297||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 8: 25 minutes post-CAC||||0.4297
70937750|NCT02978183|141375163|SUPERIORITY|||||||0.4791||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 8: 30 minutes post-CAC||||0.4791
70937751|NCT02102724|141375175|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||The null hypotheses were that there are no differences between the two groups' change scores for any study outcomes. The power analysis was based on a study of krill oil for reducing CRP levels in persons with arthritis (N = 90) that yielded an effect size (Cohen's d) of 1.2. A sample size of 37 was determined to yield a power of 0.80 to detect an effect size of 1.0 with a two-tailed alpha of 0.05.|The change scores of the two groups (week 12 minus baseline) were compared using Wilcoxon rank sum tests.|||< 0.05
70937752|NCT02429115|141375187|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
70937753|NCT02429115|141375188|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
70937754|NCT02429115|141375189|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
70937755|NCT01450397|141375213|SUPERIORITY_OR_OTHER||||||<|0.0013|||||||t-test, 2 sided|||||||<0.0013
71064184|NCT02712554|141637246|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emin: Treatment B (high-dose CL-108) - Placebo||||<0.0001
70937756|NCT01964547|141375214|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size is adequate to confirm the non-inferiority of Sativex with a clinical relevant reduction delta of 10%, assuming there is no difference between treatments in the actual change in cognition and also assuming a standard deviation for treatment difference of 10, using a one-tailed 2.5% significance level and power of 90%. Sativex is deemed to be non-inferior to placebo if the lower 1-sided 97.5% CI of the estimated mean treatment difference (Sativex-Placebo) is greater than -10%.|Estimated mean treatment difference|-1.47|STANDARD_ERROR_OF_MEAN|2.492|||ONE_SIDED|97.5|-6.41||||ANCOVA|||The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment group and center grouping as factors and the baseline score as covariate. The planned sample size was 120 participants(60 patients in the Sativex arm and 60 in the placebo arm).|||-6.41|
70937757|NCT01964547|141375215|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sativex is deemed to be non-inferior to placebo if the upper 1-sided 97.5% CI of the estimated mean treatment difference (Sativex-Placebo) is less than +5%.|Estimated mean treatment difference|-0.29|STANDARD_ERROR_OF_MEAN|1.323|||ONE_SIDED|97.5||2.33|||ANCOVA|||The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment group and center grouping as factors and the baseline score as covariate.||2.33||
70937758|NCT01964547|141375216|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.02||||0.0001|TWO_SIDED|95.0|1.96|8.22|||Regression, Logistic|||Data were analysed using ordinal logistic regression using the cumulative proportional odds model, with global impression of change as the dependent variable and treatment group as factor.||8.22|1.96|0.0001
71064185|NCT02712554|141637247|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0024|||||||ANOVA|||TA\_AUE0-8hr: Treatment C (low-dose M366) - Placebo||||0.0024
71064186|NCT02712554|141637247|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012|||||||ANOVA|||TA\_AUE0-8hr: Treatment D (high-dose M366) - Placebo||||0.0012
71064187|NCT02712554|141637247|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0037|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.0037
71064188|NCT02712554|141637247|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.0011
71064189|NCT02712554|141637247|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo||||<0.0001
71064190|NCT02712554|141637247|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo||||<0.0001
71064191|NCT02712554|141637248|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo||||<0.0001
71064192|NCT02712554|141637248|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo||||<0.0001
70937759|NCT01964547|141375217|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.79||||0.0142|TWO_SIDED|95.0|1.23|6.31|||Regression, Logistic|||Data were analysed using ordinal logistic regression using the cumulative proportional odds model, with global impression of change as the dependent variable and treatment group as factor.||6.31|1.23|0.0142
71064193|NCT02712554|141637248|SUPERIORITY_OR_OTHER_LEGACY|||||||0.063|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.0630
71064194|NCT02712554|141637248|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4436|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.4436
70937760|NCT01964547|141375218|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.07||||0.0019|TWO_SIDED|95.0|1.51|6.21|||Regression, Logistic|||Data were analysed using ordinal logistic regression using the cumulative proportional odds model, with global impression of change as the dependent variable and treatment group as factor.||6.21|1.51|0.0019
70937761|NCT01964547|141375219|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-2.36|STANDARD_ERROR_OF_MEAN|1.88||0.212|TWO_SIDED|95.0|-6.09|1.37|||ANCOVA|||The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment group and center grouping as factors and the baseline score as covariate.||1.37|-6.09|0.212
70937762|NCT01964547|141375222|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|4.88|STANDARD_ERROR_OF_MEAN|8.25||0.556|TWO_SIDED|95.0|-11.51|21.27|||ANCOVA|||The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment group and centre grouping as factors and baseline score as covariate.||21.27|-11.51|0.556
71064195|NCT02712554|141637248|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo||||<0.0001
71064196|NCT02712554|141637248|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo||||<0.0001
71064197|NCT02712554|141637249|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment C (low-dose M366) - Placebo||||<0.0001
71064198|NCT02712554|141637249|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment D (high-dose M366) - Placebo||||<0.0001
71064199|NCT02712554|141637249|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2335|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.2335
71064200|NCT02712554|141637249|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1808|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.1808
71064201|NCT02712554|141637249|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo||||<0.0001
70937763|NCT01964547|141375222|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann median difference|-1.0||||0.088|TWO_SIDED|95.0|-3.0|0.0|||Wilcoxon (Mann-Whitney)|||The change at end of treatment was compared between treatment groups using non-parametric methods as the distribution of data was non-normal.||0|-3|0.088
70937764|NCT00912964|141375224|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.005|TWO_SIDED|95.0|-0.74|-0.06||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.06|-0.74|0.005
70937765|NCT00912964|141375224|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.42||||0.001|TWO_SIDED|95.0|-0.76|-0.08||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.08|-0.76|0.001
70937766|NCT00912964|141375225|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.6||||0.15|TWO_SIDED|95.0|-1.6|10.8||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||10.8|-1.6|0.15
70941758|NCT04748445|141383935|OTHER||Slope|0.001128|STANDARD_ERROR_OF_MEAN|5.339||0.0366|TWO_SIDED|90.0|0.0002436|0.002013|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.002013|0.0002436|0.0366
71078394|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.618|||||TWO_SIDED|95.0|-36.22|30.99|||||Day 7, 4 Hours|||30.99|-36.22|
71111169|NCT01061723|141728659|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.559|TWO_SIDED|95.0|0.3|1.9||Threshold for significance = 0.05|Cochran-Mantel-Haenszel|||||1.9|0.3|0.559
71111170|NCT01061723|141728659|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.496|TWO_SIDED|95.0|0.6|3.4||Threshold for significance = 0.05|Cochran-Mantel-Haenszel|||||3.4|0.6|0.496
71111171|NCT01061723|141728659|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.143|TWO_SIDED|95.0|0.8|4.2||Threshold for significance = 0.05|Cochran-Mantel-Haenszel|||||4.2|0.8|0.143
71078395|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.8|||||TWO_SIDED|95.0|-13.09|54.69|||||Day 7, 4 Hours|||54.69|-13.09|
71078396|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-58.864|||||TWO_SIDED|95.0|-156.11|38.38|||||Day 7, 6 Hours|||38.38|-156.11|
71111172|NCT02476032|141728671|OTHER|||||||0.05|TWO_SIDED|90.0||||P-values for pairwise group comparisons were adjusted for multiple comparisons using the Tukey method.|t-test, 2 sided|||Within group comparisons: t-tests comparing the mean change to 0 were utilized. P-values less than 0.05 were considered statistically significant. SAS V9.3 (SAS Institute Inc., Cary, NC) was used for analysis. The sample size of 20 participants per group was based on having 90% power to detect a one standard deviation difference between the DO-strip groups and the placebo group means using ANOVA with a 0.05 level of significance.||||0.05
71078397|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-77.9|||||TWO_SIDED|95.0|-175.15|19.35|||||Day 7, 6 Hours|||19.35|-175.15|
71078398|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.323|||||TWO_SIDED|95.0|-69.0|125.65|||||Day 7, 6 Hours|||125.65|-69.00|
71078399|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.499|||||TWO_SIDED|95.0|-121.74|72.74|||||Day 7, 6 Hours|||72.74|-121.74|
71078400|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-59.755|||||TWO_SIDED|95.0|-157.82|38.31|||||Day 7, 6 Hours|||38.31|-157.82|
71078401|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.222|||||TWO_SIDED|95.0|-69.85|69.4|||||Day 7, 10 Hours|||69.40|-69.85|
71111173|NCT02476032|141728672|OTHER|||||||0.05|TWO_SIDED|90.0||||P-values for pairwise group comparisons were adjusted for multiple comparisons using the Tukey method.|t-test, 2 sided|||Within group comparisons: t-tests comparing the mean change to 0 were utilized. P-values less than 0.05 were considered statistically significant. SAS V9.3 (SAS Institute Inc., Cary, NC) was used for analysis. The sample size of 20 participants per group was based on having 90% power to detect a one standard deviation difference between the DO-strip groups and the placebo group means using ANOVA with a 0.05 level of significance.||||0.05
71111174|NCT01537315|141728678|SUPERIORITY_OR_OTHER|||||||0.4521|TWO_SIDED|||||A paired comparison between baseline CRP values with values obtained after 1, 3, and 6 months of treatment was conducted, with a p-value of 0.05 used as the a priori threshold of statistical significance.|ANOVA|||||||0.4521
71111175|NCT02975804|141728683|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
71111176|NCT02975804|141728684|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
71111177|NCT02975804|141728685|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
71111178|NCT02975804|141728686|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
71111179|NCT02975804|141728687|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
71111180|NCT02975804|141728688|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
71064202|NCT02712554|141637249|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo||||<0.0001
71111181|NCT02975804|141728692|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
71111182|NCT02975804|141728693|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
71111183|NCT04263766|141728753|EQUIVALENCE|We tested whether TMS delivered to DLPFC had a difference effect on confidence compared to delivered to Vertex.|||||<|0.001|||||||t-test, 2 sided|||Our null hypothesis is TMS to DLPFC would not lead to a significant change in confidence across all 4 delay conditions compared to TMS to the vertex.||||<.001
71111184|NCT04263766|141728753|EQUIVALENCE|We tested whether TMS to DLPFC leads to equivalent increase in confidence for four delay conditions.||||||0.99|||||||ANOVA|||||||0.99
71064203|NCT02712554|141637252|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||MPC: Treatment C (low-dose M366) - Placebo||||<0.0001
71064204|NCT02712554|141637252|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Treatment D: M366 37.5 mg/1625 mg, Treatment E: Placebo||||<0.0001
71064205|NCT02712554|141637252|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1268|||||||ANOVA|||MPC: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.1268
71064206|NCT02712554|141637252|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014|||||||ANOVA|||MPC: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.0014
71064207|NCT02712554|141637252|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||MPC: Treatment A (low-dose CL-108) - Placebo||||<0.0001
71064208|NCT02712554|141637252|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||MPC: Treatment B (high-dose CL-108) - Placebo||||<0.0001
71064209|NCT02712554|141637253|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment C (low-dose M366) - Placebo||||<0.0001
71064210|NCT02712554|141637253|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment D (high-dose M366) - Placebo||||<0.0001
71064211|NCT02712554|141637253|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.0120
71064212|NCT02712554|141637253|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||<0.0001
71064213|NCT02712554|141637253|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo||||<0.0001
71064214|NCT02712554|141637253|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo||||<0.0001
71064215|NCT03859427|141637254|NON_INFERIORITY|The non-inferiority margin was 0.87 for the estimated ORR risk ratio.|Risk Ratio (RR)|0.954||||0.0666|TWO_SIDED|95.0|0.882|1.032||P-value (2.5% significance level) of the non-inferiority test via the synthesis approach (FDA, 2016) for non-inferiority comparison of ORR between treatment arms.|Synthesis approach||Risk ratio and 95% CIs were estimated by a stratified analysis using the Cochran-Mantel-Haenszel method.|||1.032|0.882|0.0666
71064216|NCT03859427|141637256|OTHER||Odds Ratio (OR)|1.049|||||TWO_SIDED|95.0|0.653|1.683|||||Odds ratio and 95% CIs were estimated by a stratified analysis using the Cochran-Mantel-Haenszel method.|||1.683|0.653|
71064217|NCT03859427|141637262|OTHER||Odds Ratio (OR)|1.235|||||TWO_SIDED|95.0|0.775|1.97|||||Odds ratio and 95% CIs were estimated by a stratified analysis using the Cochran-Mantel-Haenszel method.|||1.970|0.775|
71064218|NCT03859427|141637263|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.657|1.711|||||Odds ratio and 95% CIs were estimated by a stratified analysis using the Cochran-Mantel-Haenszel method.|||1.711|0.657|
71064219|NCT03859427|141637264|OTHER||Least Squares (LS) Mean Difference|2.53|||||TWO_SIDED|95.0|0.38|4.69|||||Analysis was based on repeated measures analysis of covariance (ANCOVA) model, including arm, baseline scale score, randomization stratification factors and visit as repeated measure.|||4.69|0.38|
71064220|NCT03859427|141637265|OTHER||LS Mean Difference|1.73|||||TWO_SIDED|95.0|-1.26|4.72|||||Analysis was based on ANCOVA model, including arm, baseline scale score, randomization stratification factors and visit as repeated measure.|||4.72|-1.26|
71064221|NCT03859427|141637266|OTHER||LS Mean difference|-0.26|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|95.0|-2.54|2.03|||||Treatment difference at Cycle 5|||2.03|-2.54|
70937767|NCT00912964|141375225|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|12.4|||<|0.001|TWO_SIDED|95.0|6.3|18.6||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||18.6|6.3|<0.001
70937768|NCT00912964|141375226|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47||||0.007|TWO_SIDED|95.0|-0.82|-0.13||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.13|-0.82|0.007
70937769|NCT00912964|141375226|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.42||||0.015|TWO_SIDED|95.0|-0.76|-0.08||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.08|-0.76|0.015
70937770|NCT00912964|141375227|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34||||0.039|TWO_SIDED|95.0|-0.68|-0.01||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.01|-0.68|0.039
70937771|NCT00912964|141375227|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.51|||<|0.001|TWO_SIDED|95.0|-0.85|-0.17||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.17|-0.85|<0.001
70937772|NCT00912964|141375228|SUPERIORITY_OR_OTHER_LEGACY||LS Difference|-0.18||||0.3|TWO_SIDED|95.0|-0.53|0.16||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||0.16|-0.53|0.30
70937773|NCT00912964|141375228|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-0.37||||0.035|TWO_SIDED|95.0|-0.71|-0.03||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.03|-0.71|0.035
71064222|NCT03859427|141637266|OTHER||LS Mean difference|-0.48|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|-3.24|2.28|||||Treatment difference at Cycle 12|||2.28|-3.24|
71064223|NCT03859427|141637266|OTHER||LS Mean difference|1.44|STANDARD_ERROR_OF_MEAN|1.59|||TWO_SIDED|95.0|-1.69|4.58|||||Treatment difference at safety follow-up|||4.58|-1.69|
71064224|NCT01804946|141637284|NON_INFERIORITY_OR_EQUIVALENCE|The pre-determined margin of 20% of the control group effect was used.|Risk Difference (RD)|0.0||||0.05|ONE_SIDED|95.0||||One-sided, p-value was adjusted for multiple comparisons using the adaptive Holm method|Wald method of Z statistics calculation|Wald method of Z statistics computed a confidence interval of proportion difference.||PP set was analyzed||||0.05
71064225|NCT01804946|141637285|NON_INFERIORITY_OR_EQUIVALENCE|The pre-determined margin of 20% of the control group effect was used.|Risk Difference (RD)|0.0|||<|0.05|ONE_SIDED|95.0||||One-sided, p-value was adjusted for multiple comparisons using the adaptive Holm method|Wald method of Z statistics calculation|Wald method of Z statistics computed a confidence interval of proportion difference.||PP set was analyzed||||<0.05
71078402|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.222|||||TWO_SIDED|95.0|-77.28|61.98|||||Day 7, 10 Hours|||61.98|-77.28|
71078403|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.148|||||TWO_SIDED|95.0|-62.55|76.85|||||Day 7, 10 Hours|||76.85|-62.55|
71064226|NCT01804946|141637286|NON_INFERIORITY_OR_EQUIVALENCE|The clinically significant margin was assumed to be 0.2 of Oseltamivir effect|Mean Difference (Final Values)|0.0|||<|0.05|ONE_SIDED|95.0||||To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|Means were compared using the modified two-sample Student t-test including computation of a confidence interval for a difference between means||PP set was analyzed||||<0.05
71064227|NCT01804946|141637287|NON_INFERIORITY_OR_EQUIVALENCE|The clinically significant margin was assumed to be 0.2°C|Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.5|<|0.05|ONE_SIDED|95.0||||To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|Means were compared using the modified two-sample Student t-test including computation of a confidence interval for a difference between means.||PP set was analyzed||||<0.05
71064228|NCT01804946|141637288|NON_INFERIORITY_OR_EQUIVALENCE|The margin of no clinical importance was assumed to be 0.5 point or less to assess any symptom based on 4 point scale.|Mean Difference (Final Values)|0.0|||<|0.05|ONE_SIDED|95.0||||To adjust for multiple comparisons the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|Means were compared using the modified two-sample Student t-test including computation of a confidence interval for a difference between means||PP set was analyzed||||<0.05
71064229|NCT01804946|141637289|NON_INFERIORITY_OR_EQUIVALENCE|To compare the number of antipyretic intake the margin of no clinical importance was assumed to be 0.2|Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.5|<|0.05|ONE_SIDED|95.0||||To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|Means were compared using the modified two-sample Student t-test including computation of a confidence interval for a difference between means||PP set was analyzed||||<0.05
71064230|NCT01804946|141637290|NON_INFERIORITY_OR_EQUIVALENCE|To compare the quality of life total score the margin of no clinical importance was assumed to be 0.2 of Oseltamivir group value|Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|2.2|<|0.05|ONE_SIDED|95.0||||To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|The changes of means (Day 7 vs Day 1) were compared using the modified two-sample Student t-test including computation of a confidence interval||PP set was analyzed||||<0.05
71064231|NCT01804946|141637291|NON_INFERIORITY_OR_EQUIVALENCE|To compare the patient subjective health status assessment the margin of no clinical importance was assumed to be 0.2 of Oseltamivir group value|Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|18.2|<|0.05|ONE_SIDED|95.0||||To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|Changes of means (Day 7 vs Day 1) were compared using the modified two-sample Student t-test including computation of a confidence interval||PP set was analyzed||||<0.05
71064232|NCT01804946|141637292|NON_INFERIORITY_OR_EQUIVALENCE|The clinically significant difference (margin) between two percentages was assumed to be 20% or more of the effect of Oseltamivir|Risk Difference (RD)|0.0|||<|0.05|ONE_SIDED|95.0|||||The Wald method of Z statistics calcul|The Wald method of Z statistics calculation was performed including computation a confidence interval for a difference between proportions||PP set was analyzed||||<0.05
71064233|NCT00722137|141637293|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.001|TWO_SIDED|95.0|0.5|0.79|||Log Rank|Based on Log rank test stratified with International Prognostic Index (IPI) risk and stage of disease.|Hazards ratio estimate is based on a Cox´s model stratified by IPI risk and stage of disease. A hazard ratio \< 1 indicates an advantage for VcR-CAP.|||0.79|0.50|<0.001
71078404|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|32.734|||||TWO_SIDED|95.0|-36.89|102.36|||||Day 7, 10 Hours|||102.36|-36.89|
71078405|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.76|||||TWO_SIDED|95.0|-81.01|61.49|||||Day 7, 10 Hours|||61.49|-81.01|
70852623|NCT00647270|141194198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.074|TWO_SIDED|95.0|-13.3|7.4|||Chi-squared||Treatment difference between adalimumab 80 mg monthly and placebo divided by the difference between adalimumab 40 mg eow and placebo.|Adalimumab 80 mg monthly versus placebo: The null hypothesis associated with this comparison stated that adalimumab 80 mg monthly would be inferior to placebo with respect to ACR20 response percentage; the alternative hypothesis was that adalimumab 80 mg monthly would be superior to placebo with respect to ACR20 response.||7.4|-13.3|0.074
70852624|NCT00647270|141194198|NON_INFERIORITY_OR_EQUIVALENCE|A sensitivity analysis was proposed for the non-inferiority comparison. If the lower confidence limit of θ80 - θ40 was greater than -0.1, then the non-inferiority of adalimumab 80 mg monthly to adalimumab 40 mg eow would be claimed||||||0.74||95.0||||Non - inferiority of adalimumab 80 mg monthly compared with 40 mg eow could not be tested because the null hypothesis of the first comparison was not rejected.|Chi-squared|||The non-inferiority of adalimumab 80 mg monthly to adalimumab 40 mg every other week (eow) was to be claimed if at least 50% of the treatment effect of adalimumab 40 mg eow over placebo was to be achieved by adalimumab 80 mg monthly over placebo.||||0.74
70852625|NCT00647270|141194199|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||Using a fixed-sequence multiple-testing approach at an alpha level of 0.05 to test the secondary endpoints, the testing of the null-hypothesis began with the first endpoint and stopped as soon as failure to reject a hypothesis occurred (i.e., P value \> 0.05). Using this procedure, testing stopped after secondary endpoint number 1, change from Baseline in HAQ at Week 12.||||0.002
70852626|NCT00647270|141194200|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANCOVA|||Using a fixed-sequence multiple-testing approach at an alpha level of 0.05 to test the secondary endpoints, the testing of the null-hypothesis began with the first endpoint and stopped as soon as failure to reject a hypothesis occurred (i.e., P value \> 0.05). Using this procedure, testing stopped after secondary endpoint number 1, change from Baseline in HAQ at Week 12.||||0.005
70852627|NCT00647270|141194200|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||Using a fixed-sequence multiple-testing approach at an alpha level of 0.05 to test the secondary endpoints, the testing of the null-hypothesis began with the first endpoint and stopped as soon as failure to reject a hypothesis occurred (i.e., P value \> 0.05). Using this procedure, testing stopped after secondary endpoint number 1, change from Baseline in HAQ at Week 12.||||0.002
70852628|NCT00647270|141194201|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||The ANCOVA Model was adjusted for the Baseline Measure.|ANCOVA|||Using a fixed-sequence multiple-testing approach at an alpha level of 0.05 to test the secondary endpoints, the testing of the null-hypothesis began with the first endpoint and stopped as soon as failure to reject a hypothesis occurred (i.e., P value \> 0.05). Using this procedure, testing stopped after secondary endpoint number 1, change from Baseline in HAQ at Week 12.||||0.002
70937774|NCT00912964|141375229|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-0.07||||0.083|TWO_SIDED|95.0|-0.15|0.01||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||0.01|-0.15|0.083
70937775|NCT00912964|141375229|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|||<|0.001|TWO_SIDED|95.0|-0.22|-0.06||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.06|-0.22|<0.001
70937776|NCT00912964|141375230|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36||||0.004|TWO_SIDED|95.0|-0.67|-0.05||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.05|-0.67|0.004
70937777|NCT00912964|141375230|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39||||0.002|TWO_SIDED|95.0|-0.69|-0.08||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.08|-0.69|0.002
70937778|NCT00912964|141375231|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33||||0.13|TWO_SIDED|95.0|-0.76|0.1||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||0.10|-0.76|0.13
70937779|NCT00912964|141375231|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59||||0.007|TWO_SIDED|95.0|-1.01|-0.16||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.16|-1.01|0.007
70937780|NCT02978716|141375263|SUPERIORITY||Mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.58||0.7048|TWO_SIDED|95.0|-0.8|1.5||A Hochberg-based gatekeeping procedure was used to control the global family-wise error rate across the multiple null hypotheses in the strong sense at a 1-sided 0.025 level.|Analysis of covariance (ANCOVA)|||Duration of SN in Cycle 1 in Group 3 vs Group 1.||1.5|-0.8|0.7048
70937781|NCT02978716|141375263|SUPERIORITY||Mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.71||0.3364|TWO_SIDED|95.0|-0.6|2.3||2-sided p-value was calculated using a ANCOVA with study baseline ANC value as covariate, stratification factors of lines of systemic therapy, liver involvement and treatment as fixed effects.|ANCOVA|||Duration of SN in Cycle 1 in Group 2 vs Group 1.||2.3|-0.6|0.3364
71064234|NCT00722137|141637294|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.45|0.74|||Log Rank|Based on Log rank test stratified with IPI risk and stage of disease.|Hazards ratio estimate is based on a Cox´s model stratified by IPI risk and stage of disease. A hazard ratio \< 1 indicates an advantage for VcR-CAP.|||0.74|0.45|<0.001
70937782|NCT02978716|141375264|SUPERIORITY||Adjusted rate ratio|0.776|STANDARD_ERROR_OF_MEAN|0.2762||0.7048|TWO_SIDED|95.0|0.386|1.559||A 1-sided p-value was calculated using Hochberg-based gatekeeping procedure to control the global familywise error rate across the multiple null hypotheses.|Modified Poisson method|||Number of participants with SN in Group 3 vs Group 1.||1.559|0.386|0.7048
71064235|NCT00722137|141637296|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.38|0.65|||Log Rank|Based on Log rank test stratified with IPI risk and stage of disease.|Hazards ratio estimate is based on a Cox´s model stratified by IPI risk and stage of disease. A hazard ratio \< 1 indicates an advantage for VcR-CAP.|||0.65|0.38|<0.001
71064236|NCT00722137|141637297|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||=|0.001|TWO_SIDED|95.0|0.38|0.65|||Log Rank|||||0.65|0.38|=0.001
71064237|NCT00722137|141637298|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.428||||0.275|TWO_SIDED|95.0|0.749|2.722|||Cochran-Mantel-Haenszel Chi-Square||Mantel-Haenszel estimate of the common odds ratio for stratified tables is used, with IPI risk and Stage of Disease as stratification factors. An odds ratio (OR) \> 1 indicates an advantage for VcR-CAP.|||2.722|0.749|0.275
71064238|NCT00722137|141637299|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.688|||<|0.007|TWO_SIDED|95.0|1.148|2.481|||Cochran-Mantel-Haenszel Chi-Square||Mantel-Haenszel estimate of the common odds ratio for stratified tables is used, with IPI risk and Stage of Disease as stratification factors. An odds ratio (OR) \> 1 indicates an advantage for VcR-CAP.|||2.481|1.148|<0.007
71064239|NCT00722137|141637300|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.173|TWO_SIDED|95.0|0.59|1.1|||Log Rank|Based on Log rank test stratified with IPI risk and stage of disease.|Hazards ratio estimate is based on a Cox´s model stratified by IPI risk and stage of disease. A hazard ratio \< 1 indicates an advantage for VcR-CAP.|||1.10|0.59|0.173
71064240|NCT01120184|141637382|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The study was powered for superiority with target hazard ratio (HR) equal to 0.75, as well as for non-inferiority with HR equal to 1.1765 for comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm. Non-inferiority was established if the upper bound of the 97.5% CI was less than (\<) 1.1765. Superiority was achieved if the upper bound of the 97.5% CI was \<1.00.|Hazard Ratio (HR)|0.91||||0.3125|TWO_SIDED|97.5|0.73|1.13||Test and p-value apply for superiority test. Two-sided significance level of 2.5% was used to adjust for independent comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm.|Log Rank||Direction of comparison: Trastuzumab Emtansine + Placebo vs. Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||1.13|0.73|0.3125
71064241|NCT01120184|141637382|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The study was powered for superiority with target HR equal to 0.75, as well as for non-inferiority with HR equal to 1.1765 for comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm. Non-inferiority was established if the upper bound of the 97.5% CI was \<1.1765. Superiority was achieved if the upper bound of the 97.5% CI was \<1.00.|Hazard Ratio (HR)|0.87||||0.1407|TWO_SIDED|97.5|0.69|1.08||Test and p-value apply for superiority test. Two-sided significance level of 2.5% was used to adjust for independent comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm.|Log Rank||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs. Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||1.08|0.69|0.1407
71064242|NCT01120184|141637382|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The study was powered for superiority with target HR equal to 0.75, as well as for non-inferiority with HR equal to 1.1765 for comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm.|Hazard Ratio (HR)|0.91||||0.3075|TWO_SIDED|97.5|0.73|1.13||Test and p-value apply for superiority test. Primary endpoint did not meet superiority of PFS for trastuzumab emtansine + pertuzumab versus trastuzumab + taxane (two-sided significance level 2.5%); thus, tests and p-value are considered descriptive.|Log Rank||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs. Trastuzumab Emtansine + Placebo|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||1.13|0.73|0.3075
71064243|NCT01120184|141637384|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.6568|TWO_SIDED|97.5|0.73|1.2|||Log Rank||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||1.20|0.73|0.6568
71064244|NCT01120184|141637384|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.5691|TWO_SIDED|97.5|0.67|1.11|||Log Rank||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||1.11|0.67|0.5691
71064245|NCT01120184|141637386|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|97.5|0.69|1.04|||||Direction of comparison: Trastuzumab Emtasine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||1.04|0.69|
71064246|NCT01120184|141637386|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|97.5|0.63|0.95|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.95|0.63|
71064247|NCT01120184|141637388|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|97.5|0.66|0.97|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.97|0.66|
71064248|NCT01120184|141637388|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|97.5|0.65|0.95|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.95|0.65|
71064249|NCT01120184|141637398|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|-8.2|||||TWO_SIDED|95.0|-15.9|-0.5|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|||-0.5|-15.9|
70852629|NCT00647270|141194202|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||The ANCOVA Model was adjusted for Baseline Measure.|ANCOVA|The ANCOVA Model was adjusted for Baseline Measure.||Using a fixed-sequence multiple-testing approach at an alpha level of 0.05 to test the secondary endpoints, the testing of the null-hypothesis began with the first endpoint and stopped as soon as failure to reject a hypothesis occurred (i.e., P value \> 0.05). Using this procedure, testing stopped after secondary endpoint number 1, change from Baseline in HAQ at Week 12.||||0.005
70937783|NCT02978716|141375264|SUPERIORITY||Adjusted rate ratio|0.961|STANDARD_ERROR_OF_MEAN|0.364||0.9154|TWO_SIDED|95.0|0.457|2.019||The p-value was calculated using modified Poisson method adjusting for number of cycles, accounting for the number of prior lines of therapy (0 versus 1 - 2) and liver involvement as the stratification factors and baseline ANC as a covariate.|Modified Poisson Regression|||Number of participants with SN in Group 2 vs Group 1.||2.019|0.457|0.9154
70937784|NCT02978716|141375267|SUPERIORITY||Adjusted hazard ratio (HR)|0.4|STANDARD_ERROR_OF_MEAN|0.125||0.0004|TWO_SIDED|95.0|0.22|0.74||P-value was calculated using the stratified log-rank test to account for the number of prior lines of therapy (0 versus 1 - 2) and liver involvement as the stratification factors.|stratified log-rank test||Cox regression model.|Overall survival in Group 3 vs Group 1.||0.74|0.22|0.0004
70937785|NCT02978716|141375267|SUPERIORITY||Adjusted HR|0.31|STANDARD_ERROR_OF_MEAN|0.111||0.0016|TWO_SIDED|95.0|0.15|0.63||P-value was calculated using the stratified log-rank test to account for the number of prior lines of therapy (0 versus 1 - 2) and liver involvement as the stratification factors.|stratified log-rank test||Cox regression model.|Overall survival in Group 2 vs Group 1.||0.63|0.15|0.0016
70937786|NCT02978716|141375287|SUPERIORITY||Adjusted HR|0.493|STANDARD_ERROR_OF_MEAN|0.1957||0.7048|TWO_SIDED|95.0|0.226|1.073||A 1-sided p-value was calculated using Hochberg-based gatekeeping procedure to control the global familywise error rate across the multiple null hypotheses.|modified Poisson regression|||RBC Transfusions in Group 3 vs Group 1.||1.073|0.226|0.7048
70937787|NCT02978716|141375287|SUPERIORITY||Adjusted rate ratio|0.885|STANDARD_ERROR_OF_MEAN|0.3089||0.7272|TWO_SIDED|95.0|0.447|1.754||P-value was calculated using modified Poisson method adjusting for duration of treatment in days accounting for number of prior lines of therapy (0 versus 1 - 2); liver involvement as the stratification factors and baseline hemoglobin as a covariate.|Modified Poisson Regression|||RBC Transfusions in Group 2 vs Group 1.||1.754|0.447|0.7272
70937788|NCT02978716|141375288|SUPERIORITY||Adjusted rate ratio|0.988|STANDARD_ERROR_OF_MEAN|0.6105||0.7048|TWO_SIDED|95.0|0.294|3.317||A 1-sided p-value was calculated using Hochberg-based gatekeeping procedure to control the global familywise error rate across the multiple null hypotheses.|modified Poisson regression|||Platelet Transfusions in Group 3 vs Group 1.||3.317|0.294|0.7048
70937789|NCT02978716|141375288|SUPERIORITY||Adjusted rate ratio|0.527|STANDARD_ERROR_OF_MEAN|0.4077||0.4078|TWO_SIDED|95.0|0.116|2.399||P-value: calculated using modified Poisson method adjusting for duration of treatment in days accounting for number of prior lines of therapy (0 versus 1 - 2); liver involvement as stratification factors and baseline platelet count as a covariate.|Modified Poisson Regression|||Platelet Transfusions in Group 2 vs Group 1.||2.399|0.116|0.4078
71064250|NCT01120184|141637398|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|-3.7|||||TWO_SIDED|95.0|-11.4|3.9|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|||3.9|-11.4|
71064251|NCT01120184|141637398|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|4.5|||||TWO_SIDED|95.0|-3.3|12.2|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab Emtansine + Placebo|||12.2|-3.3|
70937790|NCT02978716|141375289|SUPERIORITY||Adjusted rate ratio|0.645|STANDARD_ERROR_OF_MEAN|0.1902||0.7048|TWO_SIDED|95.0|0.362|1.15||A 1-sided p-value was calculated using Hochberg-based gatekeeping procedure to control the global familywise error rate across the multiple null hypotheses.|modified Poisson regression|||G-CSF Administration in Group 3 vs Group 1.||1.150|0.362|0.7048
71064252|NCT01120184|141637399|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|-4.6|||||TWO_SIDED|95.0|-12.1|2.8|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|||2.8|-12.1|
71064253|NCT01120184|141637399|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|-1.8|||||TWO_SIDED|95.0|-9.2|5.7|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|||5.7|-9.2|
70937791|NCT02978716|141375289|SUPERIORITY||Adjusted rate ratio|0.936|STANDARD_ERROR_OF_MEAN|0.226||0.7835|TWO_SIDED|95.0|0.583|1.502||P-value was calculated using modified Poisson method adjusting for number of cycles, accounting for the number of prior lines of therapy (0 versus 1 - 2) and liver involvement as the stratification factors and baseline ANC as a covariate.|Modified Poisson Regression|||G-CSF Administration in Group 2 vs Group 1.||1.502|0.583|0.7835
70937792|NCT02978716|141375292|SUPERIORITY||Adjusted rate ratio|0.991|STANDARD_ERROR_OF_MEAN|0.3718||0.7048|TWO_SIDED|95.0|0.475|2.067||The 1-sided p-value was calculated using Hochberg-based gatekeeping procedure to control the global family wise error rate across the multiple null hypotheses.|negative binomial regression|||All-cause Dose Reductions in Group 3 vs Group 1.||2.067|0.475|0.7048
71064254|NCT01120184|141637399|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|2.9|||||TWO_SIDED|95.0|-4.5|10.3|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab Emtansine + Placebo|||10.3|-4.5|
71064255|NCT01120184|141637400|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|97.5|0.43|0.84|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.84|0.43|
71064256|NCT01120184|141637400|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.62|||||TWO_SIDED|97.5|0.45|0.85|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.85|0.45|
71078406|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.594|||||TWO_SIDED|95.0|-123.36|84.18|||||Day 7, 12 Hours|||84.18|-123.36|
71078407|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-46.924|||||TWO_SIDED|95.0|-150.69|56.85|||||Day 7, 12 Hours|||56.85|-150.69|
71111185|NCT04263766|141728753|EQUIVALENCE|We tested whether TMS delivered to Vertex leads to a same effect on confidence regardless of the delay conditions.||||||0.83|||||||ANOVA|||||||0.83
71111186|NCT04263766|141728754|EQUIVALENCE|We used a two-way ANOVA to test whether TMS affected Mratio differently for DLPFC and Vertex and across different delay conditions.|||||>|0.19|||||||ANOVA|||Our null hypothesis is TMS to DLPFC would not lead to a significant change in Mratio across all 4 delay conditions compared to TMS to the vertex.||||>0.19
71111187|NCT02553928|141728762|OTHER||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.19||0.097|TWO_SIDED|95.0|-0.06|0.69||Based on full analysis set|ANCOVA||The comparison is to BID memantine.|The ADCS-CGIC was analyzed based on an analysis of covariance (ANCOVA) of ADCS-CGIC score at Week 12, with treatment and site as fixed factors, and baseline score as a covariate using observed cases.||0.69|-0.06|0.097
71111188|NCT02440139|141728774|SUPERIORITY||difference in sensitivity|-0.124|STANDARD_DEVIATION|0.034|<|0.05|TWO_SIDED|95.0|-0.186|-0.062|||Mixed Models Analysis|||||-0.062|-0.186|<0.05
71111189|NCT02440139|141728775|SUPERIORITY||Difference in LROC curves|-0.14|STANDARD_DEVIATION|0.039|<|0.05|TWO_SIDED|95.0|-0.209|-0.071|||ANOVA|||For each study arm, the difference in the least-squares means of the two arms was estimated. A two-sided 95% confidence interval on this difference in study arms (i.e. unaided minus aided by the software) was used to test the hypothesis that the difference in the area under the LROC curve (AUC). The superiority of ClearRead CT will be concluded if the upper bound of the two-sided 95% confidence interval on the difference is less than zero.||-0.071|-0.209|<0.05
71111190|NCT02933879|141728777|SUPERIORITY|||||||0.4615|||||||Z-test, 2 sided|||||||0.4615
71111191|NCT02933879|141728779|SUPERIORITY|||||||0.0404|||||||Z-test, 2 sided|||||||0.0404
71111192|NCT02933879|141728779|SUPERIORITY|||||||0.2106|||||||Z-test, 2 sided|||||||0.2106
71111193|NCT02933879|141728781|SUPERIORITY|||||||1|||||||Z-test, 2 sided|||||||1.0000
71111194|NCT02933879|141728783|SUPERIORITY|||||||1|||||||Z-test, 2 sided|||||||1.0000
71111195|NCT02933879|141728786|SUPERIORITY|||||||0.2467|||||||Z-test, 2 sided|||||||0.2467
71111196|NCT00075764|141728789|OTHER||Hazard Ratio (HR)|0.8||||0.007|TWO_SIDED|95.0|0.68|0.94|||Log Rank|Two-sided stratified log-rank test||||0.94|0.68|0.007
71111197|NCT00075764|141728791|OTHER||Hazard Ratio (HR)|0.81||||0.049|TWO_SIDED|95.0|0.65|1.0|||Log Rank|A log-rank test, stratified according to prior or no prior tamoxifen therapy.||||1.00|0.65|0.049
71111198|NCT01773967|141728811|SUPERIORITY|||||||0.83|||||||Mantel Haenszel|||||||0.83
71111199|NCT01773967|141728813|SUPERIORITY|||||||0.26|||||||Van Elteren's modification Mann-Whitney|||||||0.26
71111200|NCT01135459|141728814|OTHER||Odds Ratio (OR)|0.7649||||0.3989|TWO_SIDED|95.0|0.4|1.4|||Regression, Logistic|||Analysis was performed using a logistic regression model with treatment and stratification factors as main factors.||1.4|0.4|0.3989
71111201|NCT02413996|141728841|SUPERIORITY||Mean Difference (Net)|5.94|STANDARD_DEVIATION|5.3||0.05|TWO_SIDED|95.0|-4.62|16.51|||t-test, 2 sided|||Does VRRS rehabilitation is superior to the traditional one?||16.51|-4.62|0.05
71111202|NCT01672879|141728850|SUPERIORITY||Difference in LSMeans [SIM - Placebo]|0.1|||||TWO_SIDED|95.0|-1.2|1.5||||||A mixed-effect model for repeated measures (MMRM) with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% confidence interval (CI) for the treatment difference between each treatment arm and placebo in least squares mean (LSMean) change from baseline in HVPG at Week 96. With MMRM setting, all participants with available data from 3 treatment groups with change in HVPG at Week 96 contributed to the overall model.||1.5|-1.2|
71111203|NCT01672879|141728850|SUPERIORITY||Difference in LSMeans [SIM - Placebo]|0.1|||||TWO_SIDED|95.0|-1.2|1.4||||||An MMRM with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% CI for the treatment difference between each treatment arm and placebo in LSMean change from baseline in HVPG at Week 96. With MMRM setting, all participants with available data from 3 treatment groups with change in HVPG at Week 96 contributed to the overall model.||1.4|-1.2|
71111204|NCT01672879|141728851|SUPERIORITY|||||||0.41|||||||Stratified log-rank test|||Differences in EFS between a given SIM group and placebo were assessed using the log-rank test stratified by HVPG category (\< 10 mmHg vs ≥ 10 mmHg) and presence or absence of diabetes at baseline.||||0.41
71111205|NCT01672879|141728851|SUPERIORITY|||||||0.065|||||||Stratified log-rank test|||Differences in EFS between a given SIM group and placebo were assessed using the log-rank test stratified by HVPG category (\< 10 mmHg vs ≥ 10 mmHg) and presence or absence of diabetes at baseline.||||0.065
71111206|NCT02948582|141728889|SUPERIORITY||least squares mean|0.033||||0.1257|TWO_SIDED|95.0|-0.009|0.075|||least squares mean|||"An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.~A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2."||0.075|-0.009|0.1257
71117651|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
71117652|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
71117653|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
70937793|NCT02978716|141375292|SUPERIORITY||Adjusted rate ratio|0.82|STANDARD_ERROR_OF_MEAN|0.2744||0.5541|TWO_SIDED|95.0|0.426|1.58||P-value was calculated using negative binomial method adjusting for number of cycles, accounting for the number of prior lines of therapy (0 versus 1 - 2) and liver involvement as the stratification factors.|negative binomial regression|||All-cause Dose Reductions in Group 2 vs Group 1.||1.580|0.426|0.5541
70937794|NCT00960206|141375298|SUPERIORITY_OR_OTHER|||||||0.0832|||||||Log Rank|||To compare the Kaplan-Meier survivorship between the two systems||||0.0832
70937795|NCT00960206|141375298|SUPERIORITY_OR_OTHER|||||||0.1657|||||||Log Rank|||To compare the Kaplan-Meier survivorship between the two systems||||0.1657
70937796|NCT00960206|141375299|SUPERIORITY_OR_OTHER|||||||0.3701|||||||Fisher Exact|||To compare the # of cases at 10 years for those that have a HHS ≥ 80 to those that have \< 80 for all three arms||||0.3701
70937797|NCT00960206|141375301|SUPERIORITY_OR_OTHER|||||||0.6011|||||||Fisher Exact|||Compare the # of cases at 10 years satisfied with their total hip replacement for all three groups||||0.6011
70937798|NCT00960206|141375301|SUPERIORITY_OR_OTHER|||||||0.206|||||||Fisher Exact|||Compare the # of cases at 10 years for having pain in their hip for all three groups||||0.2060
70937799|NCT02470806|141375302|NON_INFERIORITY|Stepwise regression method - Primary efficacy analysis, difference between treatment groups in percentage change in wound area from baseline visit to end of 12-week treatment period for the PP population.||||||0.001|TWO_SIDED|95.0|||||Stepwise regression|||Percentage change in wound area from Baseline to end of 12-week treatment period (PP population - all wounds)||||0.001
70937800|NCT01094106|141375315|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||In a previous non-randomised study at our institution, the mean oxycodone consumption in the control group was 60.7 mg (SD, 22.2 mg) during the first 48 h after caesarean section. At α = 0.05, 31 patients would be needed in each group to achieve a power of 90% for detecting a 30% reduction in the need for rescue opioids, which we considered a clinically meaningful effect. We decided to enrol 70 patients. The final study population was 67 patients.||||0.10
70937801|NCT01094106|141375316|SUPERIORITY|||||||0.08||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores at rest, 0-6 h||||0.08
70937802|NCT01094106|141375316|SUPERIORITY|||||||0.86||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores at rest, 6-12 h||||0.86
70937803|NCT01094106|141375316|SUPERIORITY|||||||0.66||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores at rest, 12-24 h||||0.66
70937804|NCT01094106|141375316|SUPERIORITY|||||||0.79||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores at rest, 24-36 h||||0.79
70937805|NCT01094106|141375316|SUPERIORITY|||||||0.2||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores at rest, 36-48 h||||0.20
70937806|NCT01094106|141375316|SUPERIORITY|||||||0.36||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores when moving, 0-6 h||||0.36
70937807|NCT01094106|141375316|SUPERIORITY|||||||0.43||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores when moving, 6-12 h||||0.43
70937808|NCT01094106|141375316|SUPERIORITY|||||||0.68||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores when moving, 12-24 h||||0.68
70937809|NCT01094106|141375316|SUPERIORITY|||||||0.37||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores when moving, 24-36 h||||0.37
70937810|NCT01094106|141375316|SUPERIORITY|||||||0.06||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores when moving, 36-48 h||||0.06
70937811|NCT01094106|141375317|SUPERIORITY|||||||0.3|||||||Chi-squared|||||||0.30
70937812|NCT01294644|141375321|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.6|||<|0.001|TWO_SIDED|95.0|1.52|4.43|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|The odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 1 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||4.43|1.52|<0.001
70937813|NCT01294644|141375321|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.13|||<|0.001|TWO_SIDED|95.0|1.83|5.36|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|The odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 2 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||5.36|1.83|<0.001
70937814|NCT01294644|141375322|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.71||||0.02|TWO_SIDED|95.0|1.48|92.67|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|Odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|||92.67|1.48|0.020
70937815|NCT01294644|141375322|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.53||||0.021|TWO_SIDED|95.0|1.46|91.24|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|Odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|||91.24|1.46|0.021
71078408|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.715|||||TWO_SIDED|95.0|-79.16|128.59|||||Day 7, 12 Hours|||128.59|-79.16|
71078409|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.966|||||TWO_SIDED|95.0|-111.73|95.8|||||Day 7, 12 Hours|||95.80|-111.73|
71064257|NCT01120184|141637402|SUPERIORITY_OR_OTHER_LEGACY||Difference in Symptom Rate|-32.2|||||TWO_SIDED|95.0|-40.0|-24.0|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||-24|-40|
71064258|NCT01120184|141637402|SUPERIORITY_OR_OTHER_LEGACY||Difference in Symptom Rate|-24.2|||||TWO_SIDED|95.0|-32.0|-16.0|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||-16|-32|
71064259|NCT01120184|141637402|SUPERIORITY_OR_OTHER_LEGACY||Difference in Symptom Rate|8.0|||||TWO_SIDED|95.0|-2.3|18.4|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab Emtansine + Placebo|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||18.4|-2.3|
71064260|NCT01120184|141637406|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.57|0.86|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.86|0.57|
71064261|NCT01120184|141637406|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.55|0.84|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.84|0.55|
71064262|NCT01120184|141637410|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.4|1.15|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|||1.15|0.40|
71064263|NCT01120184|141637411|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.66|||||TWO_SIDED|95.0|0.41|1.07|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|||1.07|0.41|
71064264|NCT01120184|141637413|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|97.5|0.65|1.25|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|||1.25|0.65|
71064265|NCT01120184|141637415|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|97.5|0.74|1.34|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|||1.34|0.74|
71064266|NCT04003636|141637420|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0034|TWO_SIDED|95.0|0.72|0.95|||Regression, Cox|One-sided p-value based on log-rank test stratified by geographic region, disease status, site of origin with small strata collapsed|HR=Arm A/Arm B|||0.95|0.72|0.0034
71064267|NCT04003636|141637421|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0225|TWO_SIDED|95.0|0.75|1.0|||Regression, Cox|One-sided p-value based on log-rank test stratified by geographic region, disease status, site of origin with small strata collapsed|HR=Arm A/Arm B|||1.00|0.75|0.0225
71064268|NCT04003636|141637422|SUPERIORITY||Difference in Percentages|0.2||||0.4735|TWO_SIDED|95.0|-5.2|5.6||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0|Miettinen & Nurminen||Difference=Arm A minus Arm B|||5.6|-5.2|0.4735
71064269|NCT03656068|141637437|OTHER|Wilcoxon signed-rank test was used for statistical inference.|Median Difference (Net)|0.003||||0.0039|TWO_SIDED|||||p-value for testing median = 0|Sign test|||||||0.0039
71064270|NCT03656068|141637438|OTHER|Wilcoxon signed-rank test was used for statistical inference.|Median Difference (Net)|10.0||||0.0026|TWO_SIDED|||||p-value for testing median = 0|Sign test|||||||0.0026
70852630|NCT00835211|141194237|NON_INFERIORITY_OR_EQUIVALENCE|Analyses of Variance (ANOVA) were performed on the log-transformed AUC0-t, AUCinf and Cmax. These analyses were performed using the SAS® procedure.|Test/Ref Ratio of LS Means x 100|97.5||||||90.0|87.8|108.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||108.3|87.8|
71064271|NCT03656068|141637439|OTHER|Wilcoxon signed-rank test was used for statistical inference.|Median Difference (Net)|0.002||||0.5555|TWO_SIDED|||||p-value for testing median = 0|Sign test|||||||0.5555
71064272|NCT03656068|141637440|OTHER|Wilcoxon signed-rank test was used for statistical inference.|Median Difference (Net)|1.72||||0.3778|TWO_SIDED|||||p-value for testing median = 0|Sign test|||||||0.3778
71064273|NCT03656068|141637441|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-8.1||||0.4638|TWO_SIDED|95.0|-31.0|14.8||p-value for testing mean = 0|t-test, 2 sided|||||14.8|-31.0|0.4638
71064274|NCT03656068|141637442|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-1.65||||0.6532|TWO_SIDED|95.0|-9.26|5.97||p-value for testing mean = 0|t-test, 2 sided|||||5.97|-9.26|0.6532
71064275|NCT03656068|141637443|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.38||||0.7254|TWO_SIDED|95.0|-1.86|2.61||p-value for testing mean = 0|t-test, 2 sided|||||2.61|-1.86|0.7254
71064276|NCT03656068|141637444|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|8.77||||0.3772|TWO_SIDED|95.0|-11.7|29.25||p-value for testing mean = 0|t-test, 2 sided|||||29.25|-11.70|0.3772
71078410|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.108|||||TWO_SIDED|95.0|-103.08|109.29|||||Day 7, 12 Hours|||109.29|-103.08|
70937816|NCT01294644|141375323|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.37|||<|0.001|TWO_SIDED|95.0|3.06|9.44|||Regression, Logistic|Logistic regression analysis with treatment and Baseline SSRS value in the model.|Odds ratio was based on a logistic regression model adjusted for Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 1 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||9.44|3.06|<0.001
70937817|NCT01294644|141375323|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.62|||<|0.001|TWO_SIDED|95.0|2.65|8.04|||Regression, Logistic|Logistic regression analysis with treatment and Baseline SSRS value in the model|Odds ratio was based on a logistic regression model adjusted for Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 2 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||8.04|2.65|<0.001
70937818|NCT01294644|141375324|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.35|||<|0.001|TWO_SIDED|95.0|-0.51|-0.19|||Mixed Models Repeated Measures|The model included the fixed effect factors visit and treatment, the visit\*treatment interaction, and the Baseline CR-SMFRS values as covariate.||||-0.19|-0.51|<0.001
70937819|NCT01294644|141375324|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-0.56|-0.24|||Mixed Models Repeated Measures|The model included the fixed effect factors visit and treatment, the visit\*treatment interaction, and the baseline CR-SMFRS values as covariate.||||-0.24|-0.56|<0.001
70937820|NCT01294644|141375325|SUPERIORITY_OR_OTHER||LS Mean Difference|1.36|||<|0.001|TWO_SIDED|95.0|0.97|1.75|||ANCOVA|The model includes the fixed effect factor treatment and the Baseline values as covariate.||||1.75|0.97|<0.001
70937821|NCT01294644|141375325|SUPERIORITY_OR_OTHER||LS Mean Difference|1.26|||<|0.001|TWO_SIDED|95.0|0.87|1.65|||ANCOVA|The model includes the fixed effect factor treatment and the Baseline values as covariate.||||1.65|0.87|<0.001
71064277|NCT03656068|141637445|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.12||||0.5799|TWO_SIDED|95.0|-0.56|0.33||p-value for testing mean = 0|t-test, 2 sided|||||0.33|-0.56|0.5799
71064278|NCT03656068|141637446|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-1.89||||0.7088|TWO_SIDED|95.0|-12.65|8.87||p-value for testing mean = 0|t-test, 2 sided|||||8.87|-12.65|0.7088
71064279|NCT03656068|141637447|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.35||||0.0609|TWO_SIDED|95.0|-0.72|0.02||p-value for testing mean = 0|t-test, 2 sided|||||0.02|-0.72|0.0609
70852631|NCT00835211|141194238|NON_INFERIORITY_OR_EQUIVALENCE|Analyses of Variance (ANOVA) were performed on the log-transformed AUC0-t, AUCinf and Cmax. These analyses were performed using the SAS® procedure.|Test/Ref Ratio of LS Means x 100|95.6||||||90.0|86.9|105.2|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.2|86.9|
70937822|NCT01294644|141375326|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8||||0.09|TWO_SIDED|95.0|-1.72|0.13|||Mixed Models Repeated Measures|The model includes the fixed effect factors visit and treatment, the visit\*treatment interaction, and the Baseline values as covariate.||||0.13|-1.72|0.090
70937823|NCT01294644|141375326|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.97||||0.04|TWO_SIDED|95.0|-1.89|-0.05|||Mixed Models Repeated Measures|The model includes the fixed effect factors visit and treatment, the visit\*treatment interaction, and the Baseline values as covariate.||||-0.05|-1.89|0.040
70937824|NCT01294644|141375327|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||Pearson's chi-square test|||||||0.009
70937825|NCT01294644|141375327|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Pearson's chi-square test|||||||0.001
70937826|NCT02158806|141375364|SUPERIORITY|Participants analysed in the groups to which they were randomised (intention to treat analysis).|Cox Proportional Hazard|0.85|STANDARD_ERROR_OF_MEAN|0.146||0.246|TWO_SIDED|95.0|0.64|1.13|||Log Rank||Placebo group = reference group|Placebo group = reference group||1.13|0.64|0.246
70937827|NCT02158806|141375365|SUPERIORITY|Participants analysed in the groups to which they were randomised (intention to treat analysis).|Risk Ratio (RR)|0.88||||0.073|TWO_SIDED|95.0|0.76|1.01|||Chi-squared|||||1.01|0.76|0.073
70937828|NCT02158806|141375366|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.25|TWO_SIDED|95.0|-1.9|0.5||Adjusted for baseline values.|ANCOVA|One participant in aspirin group had missing data for 24 week endpoint visit; we used the baseline value for imputation.|Placebo group = reference group.|||0.5|-1.9|0.25
70937829|NCT02158806|141375367|SUPERIORITY||Mean Difference (Net)|1.1||||0.714|TWO_SIDED|95.0|-5.0|7.2|||Regression, Linear|Adjusted for baseline values||Change in Physical Functioning||7.2|-5.0|0.714
70937830|NCT02158806|141375367|SUPERIORITY||Mean Difference (Net)|1.4||||0.768|TWO_SIDED|95.0|-8.0|10.8|||Regression, Linear|Adjusted for baseline values||Change in Role Physical||10.8|-8.0|0.768
71064280|NCT03656068|141637448|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-6.61||||0.1556|TWO_SIDED|95.0|-16.16|2.94||p-value for testing mean = 0|t-test, 2 sided|||||2.94|-16.16|0.1556
71064281|NCT03656068|141637449|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-14.6||||0.0709|TWO_SIDED|95.0|-30.6|1.4||p-value for testing mean = 0|t-test, 2 sided|||||1.4|-30.6|0.0709
70937831|NCT02158806|141375367|SUPERIORITY||Mean Difference (Net)|2.3||||0.449|TWO_SIDED|95.0|-3.7|8.4|||Regression, Linear|Adjusted for baseline values||Change in Bodily Pain||8.4|-3.7|0.449
71064282|NCT03656068|141637450|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-3.61||||0.1799|TWO_SIDED|95.0|-9.02|1.81||p-value for testing mean = 0|t-test, 2 sided|||||1.81|-9.02|0.1799
71064283|NCT03656068|141637451|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-6.8||||0.3306|TWO_SIDED|95.0|-21.2|7.6||p-value for testing mean = 0|t-test, 2 sided|||||7.6|-21.2|0.3306
71064284|NCT03656068|141637452|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-1.94||||0.4504|TWO_SIDED|95.0|-7.25|3.37||p-value for testing mean = 0|t-test, 2 sided|||||3.37|-7.25|0.4504
70937832|NCT02158806|141375367|SUPERIORITY||Mean Difference (Net)|-0.3||||0.873|TWO_SIDED|95.0|-4.3|3.6|||Regression, Linear|Adjusted for baseline values||Change in General Health||3.6|-4.3|0.873
71064285|NCT03656068|141637453|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|33.8||||0.1349|TWO_SIDED|95.0|-11.5|79.0||p-value for testing mean = 0|t-test, 2 sided|||||79.0|-11.5|0.1349
71117654|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
70937833|NCT02158806|141375367|SUPERIORITY||Mean Difference (Net)|4.2||||0.057|TWO_SIDED|95.0|-0.1|8.5|||Regression, Linear|Adjusted for baseline values||Change in Vitality||8.5|-0.1|0.057
71064286|NCT03656068|141637454|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|76.24||||0.0117|TWO_SIDED|95.0|19.04|133.43||p-value for testing mean = 0|t-test, 2 sided|||||133.43|19.04|0.0117
71064287|NCT03656068|141637455|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|31.3||||0.4281|TWO_SIDED|95.0|-50.3|112.9||p-value for testing mean = 0|t-test, 2 sided|||||112.9|-50.3|0.4281
71064288|NCT03656068|141637456|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|117.37||||0.0407|TWO_SIDED|95.0|5.6|229.14||p-value for testing mean = 0|t-test, 2 sided|||||229.14|5.60|0.0407
71064289|NCT03656068|141637457|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|47.28||||0.7065|TWO_SIDED|95.0|-210.9|305.46||p-value for testing mean = 0|t-test, 2 sided|||||305.46|-210.90|0.7065
71064290|NCT03656068|141637458|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|43.11||||0.1693|TWO_SIDED|95.0|-19.95|106.17||p-value for testing mean = 0|t-test, 2 sided|||||106.17|-19.95|0.1693
71064291|NCT03656068|141637459|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-48.14||||0.7099|TWO_SIDED|95.0|-317.64|221.36||p-value for testing mean = 0|t-test, 2 sided|||||221.36|-317.64|0.7099
71064292|NCT03656068|141637460|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|30.03||||0.3597|TWO_SIDED|95.0|-37.48|97.55||p-value for testing mean = 0|t-test, 2 sided|||||97.55|-37.48|0.3597
71064293|NCT03656068|141637461|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|169.0||||0.9893|TWO_SIDED|95.0|-25908.2|26246.2||p-value for testing mean = 0|t-test, 2 sided|||||26246.2|-25908.2|0.9893
71064294|NCT03656068|141637462|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|13.82||||0.1454|TWO_SIDED|95.0|-5.21|32.85||p-value for testing mean = 0|t-test, 2 sided|||||32.85|-5.21|0.1454
71064295|NCT03656068|141637463|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|3016.8||||0.8089|TWO_SIDED|95.0|-22996.2|29029.7||p-value for testing mean = 0|t-test, 2 sided|||||29029.7|-22996.2|0.8089
71064296|NCT03656068|141637464|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|12.78||||0.1365|TWO_SIDED|95.0|-4.5|30.06||p-value for testing mean = 0|t-test, 2 sided|||||30.06|-4.50|0.1365
70937834|NCT02158806|141375367|SUPERIORITY||Mean Difference (Net)|1.0||||0.756|TWO_SIDED|95.0|-5.1|7.0|||Regression, Linear|Adjusted for baseline values||Change in Social Functioning||7.0|-5.1|0.756
71064297|NCT03656068|141637465|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|28.954||||0.1322|TWO_SIDED|95.0|-9.525|67.433||p-value for testing mean = 0|t-test, 2 sided|||||67.433|-9.525|0.1322
71064298|NCT03656068|141637466|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|23.99||||0.1062|TWO_SIDED|95.0|-5.59|53.57|||t-test, 2 sided|p-value for testing mean = 0||||53.57|-5.59|0.1062
71064299|NCT03656068|141637467|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|28.311||||0.0831|TWO_SIDED|95.0|-4.151|60.774||p-value for testing mean = 0|t-test, 2 sided|||||60.774|-4.151|0.0831
70852632|NCT00835211|141194239|NON_INFERIORITY_OR_EQUIVALENCE|Analyses of Variance (ANOVA) were performed on the log-transformed AUC0-t, AUCinf and Cmax. These analyses were performed using the SAS® procedure.|Test/Ref Ratio of LS Means x 100|96.5||||||90.0|87.7|106.1|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.1|87.7|
70937835|NCT02158806|141375367|SUPERIORITY||Mean Difference (Net)|3.7||||0.4|TWO_SIDED|95.0|-4.9|12.3|||Regression, Linear|Adjusted for baseline values||Change in Role Emotional||12.3|-4.9|0.400
70937836|NCT02158806|141375367|SUPERIORITY||Mean Difference (Net)|-2.3||||0.236|TWO_SIDED|95.0|-6.2|1.5|||Regression, Linear|Adjusted for baseline values||Change in Mental Health||1.5|-6.2|0.236
70937837|NCT02158806|141375368|SUPERIORITY||Mean Difference (Net)|3.4||||0.156|TWO_SIDED|95.0|-1.3|8.0||Adjusted for baseline values|Regression, Linear|||||8.0|-1.3|0.156
71064300|NCT03656068|141637468|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|32.72||||0.0543|TWO_SIDED|95.0|-0.69|66.13||p-value for testing mean = 0|t-test, 2 sided|||||66.13|-0.69|0.0543
71064301|NCT03656068|141637469|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.056||||0.6325|TWO_SIDED|95.0|-0.185|0.298||p-value for testing mean = 0|t-test, 2 sided|||||0.298|-0.185|0.6325
71064302|NCT03656068|141637470|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.46||||0.6925|TWO_SIDED|95.0|-1.94|2.87||p-value for testing mean = 0|t-test, 2 sided|||||2.87|-1.94|0.6925
71064303|NCT03656068|141637471|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.161||||0.2733|TWO_SIDED|95.0|-0.14|0.462|||t-test, 2 sided|||||0.462|-0.140|0.2733
71064304|NCT03656068|141637472|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|1.47||||0.3288|TWO_SIDED|95.0|-1.63|4.56||p-value for testing mean = 0|t-test, 2 sided|||||4.56|-1.63|0.3288
71064305|NCT03656068|141637473|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|5.649||||0.9271|TWO_SIDED|95.0|-121.923|133.22||p-value for testing mean = 0|t-test, 2 sided|||||133.220|-121.923|0.9271
71064306|NCT03656068|141637474|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.89||||0.9244|TWO_SIDED|95.0|-18.58|20.37||p-value for testing mean = 0|t-test, 2 sided|||||20.37|-18.58|0.9244
71064307|NCT03656068|141637475|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-30.244||||0.7288|TWO_SIDED|95.0|-211.93|151.441||p-value for testing mean = 0|t-test, 2 sided|||||151.441|-211.930|0.7288
70937838|NCT02158806|141375369|SUPERIORITY||Mean Difference (Net)|-1.5||||0.438|TWO_SIDED|95.0|-5.2|2.2|||Regression, Linear|Adjusted for baseline values||Change in social function||2.2|-5.2|0.438
71064308|NCT03656068|141637476|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|3.34||||0.7824|TWO_SIDED|95.0|-21.85|28.52||p-value for testing mean = 0|t-test, 2 sided|||||28.52|-21.85|0.7824
71064309|NCT03656068|141637477|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-47.629||||0.6448|TWO_SIDED|95.0|-260.433|165.176||p-value for testing mean = 0|t-test, 2 sided|||||165.176|-260.433|0.6448
71064310|NCT03656068|141637478|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.38||||0.9806|TWO_SIDED|95.0|-32.04|32.8||p-value for testing mean = 0|t-test, 2 sided|||||32.80|-32.04|0.9806
71064311|NCT03656068|141637479|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-113.616||||0.3256|TWO_SIDED|95.0|-351.124|123.891||p-value for testing mean = 0|t-test, 2 sided|||||123.891|-351.124|0.3256
71064312|NCT03656068|141637480|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|8.78||||0.6582|TWO_SIDED|95.0|-32.52|50.09||p-value for testing mean = 0|t-test, 2 sided|||||50.09|-32.52|0.6582
71064313|NCT03656068|141637481|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.2438||||0.5459|TWO_SIDED|95.0|-1.0847|0.5972||p-value for testing mean = 0|t-test, 2 sided|||||0.5972|-1.0847|0.5459
71064314|NCT03656068|141637482|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|23.91||||0.286|TWO_SIDED|95.0|-22.15|69.97|||t-test, 2 sided|||||69.97|-22.15|0.2860
71064315|NCT03656068|141637483|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.2893||||0.4887|TWO_SIDED|95.0|-1.158|0.5794||p-value for testing mean = 0|t-test, 2 sided|||||0.5794|-1.1580|0.4887
70937839|NCT02158806|141375369|SUPERIORITY||Mean Difference (Net)|-1.3||||0.408|TWO_SIDED|95.0|-4.5|1.9|||Regression, Linear|Adjusted for baseline values||Change in domestic activities||1.9|-4.5|0.408
71064316|NCT03656068|141637484|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|30.27||||0.361|TWO_SIDED|95.0|-38.21|98.75||p-value for testing mean = 0|t-test, 2 sided|||||98.75|-38.21|0.3610
71064317|NCT03656068|141637485|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.63||||0.4945|TWO_SIDED|95.0|-2.51|1.26||p-value for testing mean = 0|t-test, 2 sided|||||1.26|-2.51|0.4945
71064318|NCT03656068|141637486|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.99||||0.8191|TWO_SIDED|95.0|-9.94|7.95||p-value for testing mean = 0|t-test, 2 sided|||||7.95|-9.94|0.8191
71064319|NCT03656068|141637487|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-3.22||||0.0243|TWO_SIDED|95.0|-5.96|-0.47||p-value for testing mean = 0|t-test, 2 sided|||||-0.47|-5.96|0.0243
71064320|NCT03656068|141637488|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-9.94||||0.0493|TWO_SIDED|95.0|-19.84|-0.04||p-value for testing mean = 0|t-test, 2 sided|||||-0.04|-19.84|0.0493
71064321|NCT03656068|141637489|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.6||||0.3066|TWO_SIDED|95.0|-0.59|1.79||p-value for testing mean = 0|t-test, 2 sided|||||1.79|-0.59|0.3066
71064322|NCT03656068|141637490|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|3.4||||0.2671|TWO_SIDED|95.0|-2.82|9.63||p-value for testing mean = 0|t-test, 2 sided|||||9.63|-2.82|0.2671
71064323|NCT03656068|141637491|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.11||||0.8241|TWO_SIDED|95.0|-0.94|1.16||p-value for testing mean = 0|t-test, 2 sided|||||1.16|-0.94|0.8241
71064324|NCT03656068|141637492|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|1.1||||0.7587|TWO_SIDED|95.0|-6.37|8.57||p-value for testing mean = 0|t-test, 2 sided|||||8.57|-6.37|0.7587
70937840|NCT02158806|141375369|SUPERIORITY||Mean Difference (Net)|-1.3||||0.568|TWO_SIDED|95.0|-5.6|3.1|||Regression, Linear|Adjusted for baseline values||Change in cosmesis||3.1|-5.6|0.568
70937841|NCT02158806|141375369|SUPERIORITY||Mean Difference (Net)|-3.0||||0.257|TWO_SIDED|95.0|-8.1|2.2|||Regression, Linear|Adjusted for baseline values||Change in emotional status||2.2|-8.1|0.257
70937842|NCT02158806|141375369|SUPERIORITY||Mean Difference (Net)|-1.9||||0.273|TWO_SIDED|95.0|-5.2|1.5|||Regression, Linear|Adjusted for baseline values||||1.5|-5.2|0.273
71064325|NCT03656068|141637493|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.567||||0.3784|TWO_SIDED|95.0|-1.88|0.746||p-value for testing mean = 0|t-test, 2 sided|||||0.746|-1.880|0.3784
71064326|NCT03656068|141637494|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-4.64||||0.3526|TWO_SIDED|95.0|-14.8|5.53||p-value for testing mean = 0|t-test, 2 sided|||||5.53|-14.80|0.3526
71064327|NCT03656068|141637495|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.098||||0.9218|TWO_SIDED|95.0|-1.978|2.173||p-value for testing mean = 0|t-test, 2 sided|||||2.173|-1.978|0.9218
71064328|NCT03656068|141637496|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.15||||0.9833|TWO_SIDED|95.0|-14.71|15.01||p-value for testing mean = 0|t-test, 2 sided|||||15.01|-14.71|0.9833
71064329|NCT03656068|141637497|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|12.68||||0.3957|TWO_SIDED|95.0|-17.79|43.16||p-value for testing mean = 0|t-test, 2 sided|||||43.16|-17.79|0.3957
71064330|NCT03656068|141637498|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|3.81||||0.344|TWO_SIDED|95.0|-4.39|12.01||p-value for testing mean = 0|t-test, 2 sided|||||12.01|-4.39|0.3440
71064331|NCT03656068|141637499|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|15.22||||0.0607|TWO_SIDED|95.0|-0.77|31.21||p-value for testing mean = 0|t-test, 2 sided|||||31.21|-0.77|0.0607
71064332|NCT03656068|141637500|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|5.83||||0.0644|TWO_SIDED|95.0|-0.39|12.05||p-value for testing mean = 0|t-test, 2 sided|||||12.05|-0.39|0.0644
71064333|NCT03656068|141637501|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.3665||||0.0487|TWO_SIDED|95.0|-0.7306|-0.0023||p-value for testing mean = 0|t-test, 2 sided|||||-0.0023|-0.7306|0.0487
71064334|NCT03656068|141637502|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|16.64||||0.5919|TWO_SIDED|95.0|-47.25|80.54||p-value for testing mean = 0|t-test, 2 sided|||||80.54|-47.25|0.5919
71064335|NCT03656068|141637503|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.2679||||0.1272|TWO_SIDED|95.0|-0.634|0.0983||p-value for testing mean = 0|t-test, 2 sided|||||0.0983|-0.6340|0.1272
71064336|NCT03656068|141637504|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|15.02||||0.5881|TWO_SIDED|95.0|-47.55|77.59||p-value for testing mean = 0|t-test, 2 sided|||||77.59|-47.55|0.5881
71064337|NCT03656068|141637505|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.18||||0.1458|TWO_SIDED|95.0|-0.42|0.07|||t-test, 2 sided|||||0.07|-0.42|0.1458
71064338|NCT03656068|141637506|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-11.53||||0.1495|TWO_SIDED|95.0|-27.61|4.54||p-value for testing mean = 0|t-test, 2 sided|||||4.54|-27.61|0.1495
71064339|NCT03656068|141637507|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.12||||0.3174|TWO_SIDED|95.0|-0.4|0.15||p-value for testing mean = 0|t-test, 2 sided|||||0.15|-0.40|0.3174
71064340|NCT03656068|141637508|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-8.02||||0.242|TWO_SIDED|95.0|-22.86|6.82||p-value for testing mean = 0|t-test, 2 sided|||||6.82|-22.86|0.2420
71064341|NCT00162981|141637515|SUPERIORITY_OR_OTHER||||||<|0.0182||95.0|||||1-sided Wilcoxon signed rank test|1-sided Wilcoxon signed rank test was used to assess the difference from baseline.||||||<0.0182
71064342|NCT00162981|141637515|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||1-sided Wilcoxon signed rank test was used to assess the difference from baseline.|1-sided Wilcoxon signed rank test|||||||0.0001
71064343|NCT00162981|141637518|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a standard deviation of 50%, one-tailed significance at 0.05 and a power of 80% to detect a reduction of at least 25% (baseline to final in a within-subjects design), then approximately 27 subjects would have been required in each treatment arm. Assuming a 10% drop-out rate, then approximately 30 subjects per treatment were to be enrolled in the study.|||||<|0.0001||95.0|||||1-sided Wilcoxon Rank-Sum Test|1-sided Wilcoxon Rank-Sum Test was used to compare the high dose group to the low dose group.||||||<0.0001
71064344|NCT00300235|141637524|SUPERIORITY_OR_OTHER||proportion of subjects|35.2||||||95.0|32.5|37.9||||||This was a survey designed to estimate prevalence, no formal comparisons between age or genotype groups were performed.||37.9|32.5|
71064345|NCT00455403|141637528|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.01||||0.7279|TWO_SIDED|||||"Applies to row Title year 1"|Mixed Models Analysis||"applies to row title year 1"|||||0.7279
71064346|NCT00502242|141637617|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.228||||0.0002|TWO_SIDED|95.0|0.099|0.528||2-sided p-value; alpha equals (=) 0.05|Log Rank|Stratified log-rank test with region and race strata|Stratified Cox proportional hazard model with region and race strata|||0.528|0.099|0.0002
71064347|NCT00502242|141637618|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.425||||0.0031|TWO_SIDED|95.0|0.237|0.763||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Log Rank|Stratified log-rank test with region and race strata|Stratified Cox proportional hazard model with region and race strata|||0.763|0.237|0.0031
71064348|NCT00502242|141637619|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 24 weeks post-conversion||||0.002
71064349|NCT00502242|141637619|SUPERIORITY_OR_OTHER|||||||0.074|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 52 weeks post-conversion||||0.074
71064350|NCT00502242|141637620|SUPERIORITY_OR_OTHER|||||||0.093|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 24 weeks post-conversion||||0.093
71064351|NCT00502242|141637620|SUPERIORITY_OR_OTHER|||||||0.219|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 52 weeks post-conversion||||0.219
71064352|NCT00502242|141637621|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 24 weeks post-conversion||||0.002
71064353|NCT00502242|141637621|SUPERIORITY_OR_OTHER|||||||0.121|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 52 weeks post-conversion||||0.121
71064354|NCT00502242|141637622|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.16|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 3, Ramipril||||
71064355|NCT00502242|141637622|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.36|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 3, Placebo||||
71064356|NCT00502242|141637622|SUPERIORITY_OR_OTHER||Treatment Ratio|0.85||||0.0098|TWO_SIDED|95.0|0.76|0.96||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from baseline at Week 3, Ramipril versus (vs.) Placebo||0.96|0.76|0.0098
71064357|NCT00502242|141637622|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.18|||||TWO_SIDED||||||||Adjusted for baseline|Change from baseline at Week 4, Ramipril||||
71064358|NCT00502242|141637622|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.52|||||TWO_SIDED||||||||Adjusted for baseline|Change from baseline at Week 4, Placebo||||
71064359|NCT00502242|141637622|SUPERIORITY_OR_OTHER||Treatment Ratio|0.78||||0.0003|TWO_SIDED|95.0|0.68|0.89||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from baseline at Week 4, Ramipril vs. Placebo||0.89|0.68|0.0003
70937843|NCT02158806|141375370|SUPERIORITY||Risk Ratio (RR)|1.01||||0.917|TWO_SIDED|95.0|0.87|1.17|||Chi-squared|||||1.17|0.87|0.917
70937844|NCT02158806|141375371|SUPERIORITY||Incidence Rate Ratio|1.1||||0.71|TWO_SIDED|95.0|0.7|1.7|||IRR test statistic|Incidence Rate Ratio (IRR) test statistic compared to probability of the same obtained from standard normal distribution tables.||||1.7|0.7|0.71
70937845|NCT01898299|141375373|SUPERIORITY||Cohen's d effectsize|0.48||||0.036|TWO_SIDED||||||ANCOVA|Control for Chlopromazine equivalents||||||0.036
71064360|NCT00502242|141637622|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.27|||||TWO_SIDED||||||||Adjusted for baseline|Change from baseline at Week 8, Ramipirl||||
71064361|NCT00502242|141637622|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.61|||||TWO_SIDED||||||||Adjusted for baseline|Change from baseline at Week 8, Placebo||||
71064362|NCT00502242|141637622|SUPERIORITY_OR_OTHER||Treatment Ratio|0.79||||0.0016|TWO_SIDED|95.0|0.68|0.91||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 8, Ramipril vs. Placebo||0.91|0.68|0.0016
71064363|NCT00502242|141637622|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.34|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 12, Ramipril||||
71064364|NCT00502242|141637622|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.63|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 12, Placebo||||
71064365|NCT00502242|141637622|SUPERIORITY_OR_OTHER||Treatment Ratio|0.82||||0.0165|TWO_SIDED|95.0|0.7|0.96||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 12, Ramipril vs. Placebo||0.96|0.70|0.0165
71064366|NCT00502242|141637622|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.48|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 24, Ramipril||||
71064367|NCT00502242|141637622|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.78|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 24, Placebo||||
71064368|NCT00502242|141637622|SUPERIORITY_OR_OTHER||Treatment Ratio|0.83||||0.0264|TWO_SIDED|95.0|0.7|0.98||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 24, Ramipril vs. Placebo||0.98|0.70|0.0264
71064369|NCT00502242|141637622|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.43|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 30, Ramipril||||
71064370|NCT00502242|141637622|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.82|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 30, Placebo||||
71064371|NCT00502242|141637622|SUPERIORITY_OR_OTHER||Treatment Ratio|0.79||||0.0062|TWO_SIDED|95.0|0.66|0.93||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 30, Ramipril vs. Placebo||0.93|0.66|0.0062
71064372|NCT00502242|141637622|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.4|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 36, Ramipril||||
70852633|NCT05498701|141194254|OTHER||Ratios of Adjusted Geometric Means|93.19|||||TWO_SIDED|90.0|87.1|99.7||||||Bioequivalence of the Test treatment (Tafamidis free acid 12.2 mg oral tablet \[Fasted\]) to Reference treatment (Tafamidis meglumine 20 mg oral capsule \[Fasted\]) was concluded if the 90% confidence intervals for the ratios of adjusted geometric means for tafamidis AUCinf fell entirely within the acceptance region of (80%,125%).||99.70|87.10|
70937846|NCT04919499|141375410|OTHER|A mixed model with repeated measurements (MMRM) was used for the analysis with fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.|Adjusted mean difference|-0.0252|STANDARD_ERROR_OF_MEAN|0.0376|||TWO_SIDED|95.0|-0.1048|0.0545|||||Calculated as \[high-dose BI 765128\] - \[Sham\]|||0.0545|-0.1048|
71064373|NCT00502242|141637622|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.67|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 36, Placebo||||
71064374|NCT00502242|141637622|SUPERIORITY_OR_OTHER||Treatment Ratio|0.84||||0.0341|TWO_SIDED|95.0|0.72|0.99||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 36, Ramipril vs. Placebo||0.99|0.72|0.0341
70941759|NCT04748445|141383935|OTHER||Slope|-0.0003297|STANDARD_ERROR_OF_MEAN|5.134||0.522|TWO_SIDED|90.0|-0.00118|0.0005212|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0005212|-0.001180|0.5220
71064375|NCT00502242|141637622|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.56|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 52, Ramipril||||
71064376|NCT00502242|141637622|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.86|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 52, Placebo||||
71064377|NCT00502242|141637622|SUPERIORITY_OR_OTHER||Treatment Ratio|0.84||||0.06|TWO_SIDED|95.0|0.7|1.01||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 52, Ramipril vs. Placebo||1.01|0.70|0.0600
71064378|NCT00502242|141637623|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.46|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 3, Ramipril||||
71064379|NCT00502242|141637623|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.05|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 3, Placebo||||
71078411|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.114|||||TWO_SIDED|95.0|-25.12|4.89|||||Day 14, 24 Hours|||4.89|-25.12|
71111207|NCT02948582|141728889|SUPERIORITY||least squares mean|0.072||||0.0008|TWO_SIDED|95.0|0.03|0.113|||least squares mean|||"An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.~A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2."||0.113|0.030|0.0008
71111208|NCT02948582|141728889|SUPERIORITY||least squares mean|0.102|||<|0.0001|TWO_SIDED|95.0|0.061|0.144|||least squares mean|||"An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.~A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2."||0.144|0.061|<0.0001
71111209|NCT02948582|141728889|SUPERIORITY||least squares mean|0.108|||<|0.0001|TWO_SIDED|95.0|0.066|0.15|||least squares mean|||"An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.~A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2."||0.150|0.066|<0.0001
71111210|NCT02948582|141728889|SUPERIORITY||least squares mean|0.098|||<|0.0001|TWO_SIDED|95.0|0.056|0.14|||least squares mean|||"An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.~A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2."||0.140|0.056|<0.0001
71064380|NCT00502242|141637623|SUPERIORITY_OR_OTHER||Treatment Ratio|0.71||||0.0034|TWO_SIDED|95.0|0.57|0.89||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 3, Ramipril vs. Placebo||0.89|0.57|0.0034
71064381|NCT00502242|141637623|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.43|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 4, Ramipril||||
71064382|NCT00502242|141637623|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.37|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 4, Placebo||||
71064383|NCT00502242|141637623|SUPERIORITY_OR_OTHER||Treatment Ratio|0.6|||<|0.0001|TWO_SIDED|95.0|0.47|0.76||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 4, Ramipril vs. Placebo||0.76|0.47|<0.0001
71064384|NCT00502242|141637623|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.67|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 8, Ramipril||||
71064385|NCT00502242|141637623|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.74|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 8, Placebo||||
71064386|NCT00502242|141637623|SUPERIORITY_OR_OTHER||Treatment Ratio|0.61||||0.0002|TWO_SIDED|95.0|0.47|0.79||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 8, Ramipril vs. Placebo||0.79|0.47|0.0002
71111211|NCT02948582|141728890|SUPERIORITY||least squares mean|0.086|||<|0.0001|TWO_SIDED|95.0|0.05|0.123|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC0\_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.123|0.050|<0.0001
71111212|NCT02948582|141728890|SUPERIORITY||least squares mean|0.151|||<|0.0001|TWO_SIDED|95.0|0.114|0.187|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC0\_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.187|0.114|<0.0001
71111213|NCT02948582|141728890|SUPERIORITY||least squares mean|0.156|||<|0.0001|TWO_SIDED|95.0|0.12|0.193|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC0\_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.193|0.120|<0.0001
70937847|NCT04919499|141375411|OTHER|A mixed model with repeated measurements (MMRM) was used for the analysis with fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.|Adjusted mean difference|-0.0101|STANDARD_ERROR_OF_MEAN|0.0236|||TWO_SIDED|95.0|-0.0625|0.0422|||||Calculated as \[high-dose BI 765128\] - \[Sham\]|||0.0422|-0.0625|
70937848|NCT04919499|141375412|OTHER|A mixed model with repeated measurements (MMRM) was used for the analysis with fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.|Adjusted mean difference|0.0016|STANDARD_ERROR_OF_MEAN|0.0181|||TWO_SIDED|95.0|-0.0504|0.0536|||||Calculated as \[high-dose BI 765128\] - \[Sham\]|||0.0536|-0.0504|
70937849|NCT04919499|141375413|OTHER|A mixed model with repeated measurements (MMRM) was used for the analysis with fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.|Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|2.4|||TWO_SIDED|95.0|-4.7|5.0|||||"Calculated as \[high-dose BI 765128\] - \[Sham\]~Results were rounded to one decimal place."|||5.0|-4.7|
70937850|NCT04520256|141375435|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
70937851|NCT04520256|141375436|SUPERIORITY||Estimated Change|-0.27||||0.693|TWO_SIDED|95.0|-0.54|0.01|||Mixed Models Analysis|||||0.01|-.54|0.693
71064387|NCT00502242|141637623|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.91|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 12, Ramipril||||
71064388|NCT00502242|141637623|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.92|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 12, Placebo||||
70937852|NCT04520256|141375436|SUPERIORITY||Estimated Change|0.09||||0.9|TWO_SIDED|95.0|0.01|0.18|||Mixed Models Analysis|||||0.18|0.01|0.900
70937853|NCT04520256|141375436|SUPERIORITY||Estimated Change|-0.03||||0.96|TWO_SIDED|95.0|-0.06|0.01|||Mixed Models Analysis|||||0.01|-0.06|0.960
71064389|NCT00502242|141637623|SUPERIORITY_OR_OTHER||Treatment Ratio|0.65||||0.0032|TWO_SIDED|95.0|0.49|0.87||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 12, Ramipril vs. Placebo||0.87|0.49|0.0032
71064390|NCT00502242|141637623|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.33|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 24, Ramipril||||
70937854|NCT04520256|141375436|SUPERIORITY||Estimated Change|0.44||||0.113|TWO_SIDED|95.0|0.01|0.88|||Mixed Models Analysis|||||0.88|0.01|0.113
71064391|NCT00502242|141637623|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|3.39|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 24, Placebo||||
71064392|NCT00502242|141637623|SUPERIORITY_OR_OTHER||Treatment Ratio|0.69||||0.013|TWO_SIDED|95.0|0.51|0.92||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 24, Ramipril vs. Placebo||0.92|0.51|0.0130
71064393|NCT00502242|141637623|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.5|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 30, Ramipril||||
70937855|NCT04520256|141375436|SUPERIORITY||Estimated Change|0.92||||0.187|TWO_SIDED|95.0|0.01|1.84|||Mixed Models Analysis|||||1.84|0.01|0.187
70937856|NCT04520256|141375437|SUPERIORITY|||||||0.999|||||||Mixed Models Analysis|||||||0.999
70937857|NCT04520256|141375438|SUPERIORITY||Estimated Proportion|0.12||||0.999|TWO_SIDED|95.0|0.0|0.56|||Mixed Models Analysis|||||.56|0|.999
70937858|NCT04520256|141375438|SUPERIORITY||Estimated Proportion|0.15||||0.999|TWO_SIDED|95.0|0.0|0.68|||Mixed Models Analysis|||||.68|0|.999
71064394|NCT00502242|141637623|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|3.39|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 30, Placebo||||
71064395|NCT00502242|141637623|SUPERIORITY_OR_OTHER||Treatment Ratio|0.74||||0.0577|TWO_SIDED|95.0|0.54|1.01||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 30, Ramipril vs. Placebo||1.01|0.54|0.0577
71064396|NCT00502242|141637623|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.52|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 36, Ramipril||||
70937859|NCT04520256|141375438|SUPERIORITY||Estimated Proportion|0.11||||0.999|TWO_SIDED|95.0|0.0|0.52|||Mixed Models Analysis|||||.52|0|.999
70937860|NCT04520256|141375438|SUPERIORITY||Estimated Proportion|0.11||||0.999|TWO_SIDED|95.0|0.0|0.5|||Mixed Models Analysis|||||.50|0|.999
70937861|NCT04520256|141375438|SUPERIORITY||Estimated Proportion|0.1||||0.999|TWO_SIDED|95.0|0.0|0.47|||Mixed Models Analysis|||||.47|0|.999
70937862|NCT03786471|141375445|SUPERIORITY||marginal difference of LS means|0.3||||0.33|TWO_SIDED|97.5|-0.18|0.78||Alpha = 0.025; Hochberg correction for three pairwise comparisons|Mixed Models Analysis|||||0.78|-0.18|0.33
70937863|NCT03786471|141375445|SUPERIORITY||marginal difference of LS means|-0.62||||0.33|TWO_SIDED|97.5|-1.61|0.37||Alpha = 0.025; Hochberg correction for three pairwise comparisons|Mixed Models Analysis|||||0.37|-1.61|0.33
70937864|NCT03786471|141375445|SUPERIORITY||marginal difference of LS means|-0.33||||0.46|TWO_SIDED|97.5|-1.32|0.67||Alpha = 0.025; Hochberg correction for three pairwise comparisons|Mixed Models Analysis|||||0.67|-1.32|0.46
70937865|NCT03786471|141375452|SUPERIORITY||marginal difference of LS means|0.25||||0.54|TWO_SIDED|97.5|-0.16|0.66||Alpha = 0.025; Hochberg correction for three pairwise comparisons|Mixed Models Analysis|||||0.66|-0.16|0.54
71064397|NCT00502242|141637623|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|3.27|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 36, Placebo||||
71078412|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.718|||||TWO_SIDED|95.0|-23.71|6.28|||||Day 14, 24 Hours|||6.28|-23.71|
70937866|NCT03786471|141375452|SUPERIORITY||marginal difference of LS means|-0.1||||0.79|TWO_SIDED|97.5|-0.94|0.74||Alpha = 0.025; Hochberg correction for three pairwise comparisons|Mixed Models Analysis|||||0.74|-0.94|0.79
70937867|NCT03786471|141375452|SUPERIORITY||marginal difference of LS means|0.14||||0.79|TWO_SIDED|97.5|-0.7|0.99||Alpha = 0.025; Hochberg correction for three pairwise comparisons|Mixed Models Analysis|||||0.99|-0.70|0.79
70937868|NCT03786471|141375459|SUPERIORITY||marginal difference of LS means|0.52||||0.48|TWO_SIDED|95.0|-0.09|1.13||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||1.13|-.09|0.48
70937869|NCT03786471|141375459|SUPERIORITY||marginal difference of LS means|-0.81||||0.62|TWO_SIDED|95.0|-2.07|0.45||Alpha = 0.05; Hochberg correction for three pairwise comparisons \*three secondary outcomes|Mixed Models Analysis|||||0.45|-2.07|0.62
70937870|NCT03786471|141375459|SUPERIORITY||marginal difference of LS means|-1.33||||0.23|TWO_SIDED|95.0|-2.58|-0.07||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||-0.07|-2.58|0.23
70937871|NCT03786471|141375466|SUPERIORITY||marginal difference of LS means|0.28||||0.23|TWO_SIDED|95.0|0.01|0.54||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||.54|.01|0.23
70937872|NCT03786471|141375466|SUPERIORITY||marginal difference of LS means|0.01||||0.98|TWO_SIDED|95.0|-0.53|0.55||Alpha = 0.05; Hochberg correction for three pairwise comparisons \*three secondary outcomes|Mixed Models Analysis|||||.55|-.53|.98
70937873|NCT03786471|141375466|SUPERIORITY||marginal difference of LS means|-0.27||||0.65|TWO_SIDED|95.0|-0.81|0.27||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||0.27|-0.81|0.65
70937874|NCT03786471|141375471|SUPERIORITY||marginal difference of LS means|-0.16||||0.62|TWO_SIDED|95.0|-0.37|0.06||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||0.06|-0.37|0.62
71064398|NCT00502242|141637623|SUPERIORITY_OR_OTHER||Treatment Ratio|0.77||||0.1146|TWO_SIDED|95.0|0.56|1.07||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 36, Ramipril vs. Placebo||1.07|0.56|0.1146
70937875|NCT03786471|141375471|SUPERIORITY||marginal difference of LS means|0.7||||0.01|TWO_SIDED|95.0|0.26|1.14||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||1.14|0.26|0.01
70937876|NCT03786471|141375471|SUPERIORITY||marginal difference of LS means|0.85||||0.001|TWO_SIDED|95.0|0.42|1.29||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||1.29|0.42|0.001
70937877|NCT05492786|141375494|SUPERIORITY|||||||0.517||||||The p-value reported is 2-tailed and based on heteroskedasticity-robust standard errors.|Regression, Linear|||Null hypothesis: there is no difference in flu shots for patients whose clinicians were shown alerts with information about their risk status (patients randomized to the High-risk Alert or High-risk Alert with Risk Factors arms) compared with those whose clinicians were shown the standard alert. Alternative hypothesis: patients in the High-risk Alert and High-risk Alert with Risk Factors arms will exhibit improved flu vaccination rates compared with those in the standard Alert arm.||||0.517
70937878|NCT05492786|141375494|SUPERIORITY|||||||0.226||||||The p-value reported is 2-tailed and based on heteroskedasticity-robust standard errors.|Regression, Linear|||Null hypothesis: there is no difference in flu shots for patients whose clinicians were shown alerts the factors that contributed to a patient's high risk (High-risk Alert with Risk Factors arm) compared with those whose clinicians were shown the alert with risk level only (High-risk Alert arm). Alternative hypothesis: patients in the High-risk Alert with Risk Factors arm will exhibit improved flu vaccination rates compared with those in the High-risk Alert arm.||||0.226
70937879|NCT03346200|141375505|NON_INFERIORITY|The non-inferiority margin was based on the proportion of responders and was set to 17%. That is, we defined non-inferiority to mean that the proportion of responders in the non-referent study arms is not less than one third of the responders in the 20 mg group (50% minus 33% = 17%)|Median Difference (Final Values)|52.5|||<|0.01|TWO_SIDED|97.5|41.9|100.0|||one-sided Wald tests|P-values were corrected for multiple comparisons using the Holm-Bonferroni method. Non-inferiority p-values were declared if less than a=0.025||||100|41.9|<0.01
70937880|NCT00264576|141375539|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|0.85|||||TWO_SIDED|95.0|0.7|1.04|||ANOVA|||"The following hypotheses were tested for A/H1N1 strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.04|0.70|
70937881|NCT00264576|141375539|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|0.57|||||TWO_SIDED|95.0|0.46|0.7|||ANOVA|||"The following hypotheses were tested for A/H3N2 strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||0.70|0.46|
70937882|NCT00264576|141375539|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|1.14|||||TWO_SIDED|95.0|0.95|1.36|||ANOVA|||"The following hypotheses were tested for B strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.36|0.95|
71064399|NCT00502242|141637623|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.92|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 52, Ramipril||||
71064400|NCT00502242|141637623|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|3.45|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 52, Placebo||||
70941760|NCT04748445|141383935|OTHER||Slope|-2.104|STANDARD_ERROR_OF_MEAN|3.528||0.552|TWO_SIDED|90.0|-7.95|3.742|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 10 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||3.742|-7.950|0.5520
71078413|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.622|||||TWO_SIDED|95.0|-15.63|14.38|||||Day 14, 24 Hours|||14.38|-15.63|
71078414|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.454|||||TWO_SIDED|95.0|-27.78|2.88|||||Day 14, 24 Hours|||2.88|-27.78|
71078415|NCT01119846|141664797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.681|||||TWO_SIDED|95.0|-24.02|6.66|||||Day 14, 24 Hours|||6.66|-24.02|
71078416|NCT00795769|141664813|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 1 sided|||18% n=9 of the patients vomited compared to the FHCRC historic rate of 28%. p=0.03. PMID: 21372706 reference for historical data at FHCRC.||||0.03
71078417|NCT00795769|141664813|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 1 sided|||Twelve patients (24%) had a greater than two-point increase in MAT score for nausea from baseline by the end of their infusion. That rate compares to the FHCRC historic rate of 58% (p \<0.0001). PMID: 21372706 reference for historical data at FHCRC||||<0.0001
71078418|NCT01370616|141664816|NON_INFERIORITY_OR_EQUIVALENCE|If the 95% confidence interval for the estimated difference between the two groups has a lower bound greater than -15%, then ertapenem sodium will be considered at least as effective as piperacillin/tazobactam sodium.|Estimated Difference|-3.8|||||TWO_SIDED|95.0|-8.3|0.0|||||Ertapenem minus Piperacillin/tazobactam. Based on Miettinen \& Nurminen method stratified by the severity of diabetes foot infection.|||0.0|-8.3|
71078419|NCT01370616|141664817|SUPERIORITY_OR_OTHER||Estimated Difference|-1.7|||||TWO_SIDED|95.0|-5.5|1.8|||||Ertapenem minus Piperacillin/tazobactam. Based on Miettinen \& Nurminen method stratified by the severity of diabetes foot infection.|||1.8|-5.5|
71078420|NCT01370616|141664818|SUPERIORITY_OR_OTHER||Estimated Difference|-2.3|||||TWO_SIDED|95.0|-7.7|2.8|||||Ertapenem minus Piperacillin/tazobactam. Based on Miettinen \& Nurminen method stratified by the severity of diabetes foot infection.|||2.8|-7.7|
71078421|NCT01370616|141664819|SUPERIORITY_OR_OTHER||Estimated Difference|-4.1|||||TWO_SIDED|95.0|-11.9|3.4|||||Ertapenem minus Piperacillin/tazobactam. Based on Miettinen \& Nurminen method stratified by the severity of diabetes foot infection.|||3.4|-11.9|
71078422|NCT01370616|141664820|SUPERIORITY_OR_OTHER||Estimated Difference|-4.3|||||TWO_SIDED|95.0|-12.1|3.3|||||Ertapenem minus Piperacillin/tazobactam. Based on Miettinen \& Nurminen method stratified by the severity of diabetes foot infection.|||3.3|-12.1|
71078423|NCT01370616|141664821|SUPERIORITY_OR_OTHER||Estimated Difference|7.3|||||TWO_SIDED|95.0|-0.9|15.4|||||Ertapenem minus Piperacillin/tazobactam group. Based on Miettinen \& Nurminen method without adjusting strata.|||15.4|-0.9|
71078424|NCT01370616|141664822|SUPERIORITY_OR_OTHER||Estimated Difference|-2.5|||||TWO_SIDED|95.0|-8.5|3.4|||||Ertapenem minus Piperacillin/tazobactam group. Based on Miettinen \& Nurminen method without adjusting strata.|||3.4|-8.5|
71078425|NCT01370616|141664823|SUPERIORITY_OR_OTHER||Estimated Difference|1.8|||||TWO_SIDED|95.0|-2.0|5.8|||||Ertapenem minus Piperacillin/tazobactam group. Based on Miettinen \& Nurminen method without adjusting strata.|||5.8|-2.0|
71078426|NCT01370616|141664824|SUPERIORITY_OR_OTHER||Estimated Difference|-1.8|||||TWO_SIDED|95.0|-5.7|1.9|||||Ertapenem minus Piperacillin/tazobactam group. Based on Miettinen \& Nurminen method without adjusting strata.|||1.9|-5.7|
71078427|NCT00212264|141664830|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||ANOVA|||||||.001
71078428|NCT00212264|141664831|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||t-test, 1 sided|Note that the no-treatment control group completed the study after 2 months and was not included in this analysis of treatment effect durability.||||||.32
71078429|NCT03597139|141664888|SUPERIORITY||Mean Difference (Final Values)|4.6||||0.1491|TWO_SIDED|95.0|-1.7|10.9|||ANCOVA|||||10.9|-1.7|0.1491
71078430|NCT03597139|141664889|SUPERIORITY||Mean Difference (Final Values)|6.1||||0.1187|TWO_SIDED|95.0|-1.6|13.9|||ANCOVA|||||13.9|-1.6|0.1187
71078431|NCT03597139|141664890|SUPERIORITY||Mean Difference (Final Values)|6.4||||0.2128|TWO_SIDED|95.0|-3.7|16.5|||ANCOVA|||||16.5|-3.7|0.2128
71078432|NCT03597139|141664891|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.8408|TWO_SIDED|95.0|-11.8|9.6|||ANCOVA|||||9.6|-11.8|0.8408
71078433|NCT03597139|141664892|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.5356|TWO_SIDED|95.0|-6.1|11.6|||ANCOVA|||||11.6|-6.1|0.5356
71078434|NCT03597139|141664893|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.1787|TWO_SIDED|95.0|-2.7|14.1|||ANCOVA|||||14.1|-2.7|0.1787
71078435|NCT03597139|141664894|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.7666|TWO_SIDED|95.0|-12.6|9.3|||ANCOVA|||||9.3|-12.6|0.7666
71078436|NCT03597139|141664895|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.8082|TWO_SIDED|95.0|-10.7|8.4|||ANCOVA|||||8.4|-10.7|0.8082
71064401|NCT00502242|141637623|SUPERIORITY_OR_OTHER||Treatment Ratio|0.85||||0.3496|TWO_SIDED|95.0|0.6|1.2||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 52, Ramipril vs. Placebo||1.20|0.60|0.3496
71064402|NCT00502242|141637624|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 24 weeks post-conversion||||1.0000
71064403|NCT00502242|141637624|SUPERIORITY_OR_OTHER|||||||0.1115|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 52 weeks post-conversion||||0.1115
71064404|NCT00502242|141637625|SUPERIORITY_OR_OTHER||Adjusted LS Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|1.26||0.4933|TWO_SIDED|95.0|-3.33|1.61||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with MDRD change as dependent variable, treatment and region/race as factors, and baseline as covariate.|Adjusted for baseline|Change from Baseline at Week 12||1.61|-3.33|0.4933
71064405|NCT00502242|141637625|SUPERIORITY_OR_OTHER||Adjusted LS Mean Difference|2.48|STANDARD_ERROR_OF_MEAN|1.45||0.0888|TWO_SIDED|95.0|-0.38|5.33||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with MDRD change as dependent variable, treatment and region/race as factors, and baseline as covariate.|Adjusted for baseline|Change from Baseline at Week 24||5.33|-0.38|0.0888
71064406|NCT00502242|141637625|SUPERIORITY_OR_OTHER||Adjusted LS Mean Difference|2.12|STANDARD_ERROR_OF_MEAN|1.46||0.1475|TWO_SIDED|95.0|-0.75|4.99||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with MDRD change as dependent variable, treatment and region/race as factors, and baseline as covariate|Adjusted for baseline|Change from Baseline at Week 52||4.99|-0.75|0.1475
71064407|NCT00502242|141637626|SUPERIORITY_OR_OTHER||Treatment Ratio|0.84||||0.1167|TWO_SIDED|95.0|0.68|1.04||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|Log (Fraction of albumin to protein in urine) as dependent variable, treatment and region/race as factor, and Log(baseline) as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean.|Week 24||1.04|0.68|0.1167
71064408|NCT00502242|141637626|SUPERIORITY_OR_OTHER||Treatment Ratio|1.04||||0.7519|TWO_SIDED|95.0|0.82|1.31||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|Log (Fraction of albumin to protein in urine) as dependent variable, treatment and region/race as factor, and Log(baseline) as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean.|Week 52||1.31|0.82|0.7519
71064409|NCT00502242|141637627|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL, Low DBP ≤50 mmHg||||0.470
71064410|NCT00502242|141637627|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL, High DBP ≥110 mmHg||||0.220
71064411|NCT00502242|141637627|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL, Low SBP: ≤90 mmHg||||0.470
71064412|NCT00502242|141637627|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL, High SBP: ≥180 mmHg||||1.000
71064413|NCT00502242|141637627|SUPERIORITY_OR_OTHER|||||||0.725|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On Therapy, Low DBP ≤50 mmHg||||0.725
71064414|NCT00502242|141637627|SUPERIORITY_OR_OTHER|||||||0.227|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On Therapy, High DBP ≥110 mmHg||||0.227
71064415|NCT00502242|141637627|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On Therapy, Low SBP: ≤90 mmHg||||1.000
71064416|NCT00502242|141637627|SUPERIORITY_OR_OTHER|||||||0.106|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On Therapy, High SBP: ≥180 mmHg||||0.106
71064417|NCT00502242|141637627|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off Therapy, High DBP ≥110 mmHg||||1.000
71064418|NCT00502242|141637627|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off Therapy, Low SBP: ≤90 mmHg||||1.000
71064419|NCT00502242|141637627|SUPERIORITY_OR_OTHER|||||||0.475|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline, Low DBP ≤50 mmHg||||0.475
71064420|NCT00502242|141637627|SUPERIORITY_OR_OTHER|||||||0.475|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline, Low SBP: ≤90 mmHg||||0.475
71064421|NCT00502242|141637629|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline||||1.000
71064422|NCT00502242|141637629|SUPERIORITY_OR_OTHER|||||||0.626|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL||||0.626
71064423|NCT00502242|141637629|SUPERIORITY_OR_OTHER|||||||0.297|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On-Therapy||||0.297
71064424|NCT00502242|141637629|SUPERIORITY_OR_OTHER|||||||0.356|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off-Therapy||||0.356
71064425|NCT00502242|141637630|SUPERIORITY_OR_OTHER|||||||0.064|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline||||0.064
71064426|NCT00502242|141637630|SUPERIORITY_OR_OTHER|||||||0.069|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL||||0.069
71064427|NCT00502242|141637630|SUPERIORITY_OR_OTHER|||||||0.752|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On-Therapy||||0.752
71064428|NCT00502242|141637630|SUPERIORITY_OR_OTHER|||||||0.261|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off-Therapy||||0.261
71064429|NCT00502242|141637631|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.09|STANDARD_ERROR_OF_MEAN|0.1||0.381|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||TC, Week 4||||0.381
71064430|NCT00502242|141637631|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.01|STANDARD_ERROR_OF_MEAN|0.13||0.956|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||TC, Week 12||||0.956
71064431|NCT00502242|141637631|SUPERIORITY_OR_OTHER||Difference in adjusted means|0.02|STANDARD_ERROR_OF_MEAN|0.14||0.903|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||TC, Week 24||||0.903
71064432|NCT00502242|141637631|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.1|STANDARD_ERROR_OF_MEAN|0.15||0.503|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||TC, Week 52||||0.503
71064433|NCT00502242|141637631|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.451|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||HDL-C, Week 4||||0.451
71064434|NCT00502242|141637631|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.919|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||HDL-C, Week 12||||0.919
71064435|NCT00502242|141637631|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.02|STANDARD_ERROR_OF_MEAN|0.04||0.637|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||HDL-C, Week 24||||0.637
71064436|NCT00502242|141637631|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.229|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||HDL-C, Week 52||||0.229
71064437|NCT00502242|141637631|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.03|STANDARD_ERROR_OF_MEAN|0.09||0.766|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||LDL-C, Week 4||||0.766
71064438|NCT00502242|141637631|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.14|STANDARD_ERROR_OF_MEAN|0.11||0.217|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||LDL-C, Week 12||||0.217
71064439|NCT00502242|141637631|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.457|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||LDL-C, Week 24||||0.457
71064440|NCT00502242|141637631|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.26|STANDARD_ERROR_OF_MEAN|0.13||0.041|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||LDL-C, Week 52||||0.041
71064441|NCT00502242|141637631|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.25|STANDARD_ERROR_OF_MEAN|0.12||0.044|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||Triglycerides, Week 4||||0.044
71064442|NCT00502242|141637631|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.18|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||Triglycerides, Week 12||||0.180
71064443|NCT00502242|141637631|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.19|STANDARD_ERROR_OF_MEAN|0.17||0.264|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||Triglycerides, Week 24||||0.264
71064444|NCT00502242|141637631|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.14|STANDARD_ERROR_OF_MEAN|0.17||0.408|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||Triglycerides, Week 52||||0.408
71064445|NCT00502242|141637632|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.487||||0.0732|TWO_SIDED|95.0|0.887|6.978||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Log Rank||Hazard ratio was based on the Cox proportional hazards model.|||6.978|0.887|0.0732
71064446|NCT00502242|141637634|SUPERIORITY_OR_OTHER|||||||0.7165|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel row mean test||Post-SRL, AM BCAR||||0.7165
71064447|NCT00502242|141637634|SUPERIORITY_OR_OTHER|||||||0.4795|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel row mean test||Post-SRL (On-Therapy), AM BCAR||||0.4795
71064448|NCT00502242|141637635|SUPERIORITY_OR_OTHER|||||||0.4773|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Week 52||||0.4773
71064449|NCT00502242|141637636|SUPERIORITY_OR_OTHER|||||||0.124|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline||||0.124
71064450|NCT00502242|141637636|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL||||0.410
71064451|NCT00502242|141637636|SUPERIORITY_OR_OTHER|||||||0.423|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On-Therapy||||0.423
71064452|NCT00502242|141637636|SUPERIORITY_OR_OTHER|||||||0.297|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off-Therapy||||0.297
71064453|NCT00502242|141637637|SUPERIORITY_OR_OTHER|||||||0.726|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||||||0.726
71064454|NCT00502242|141637638|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||||||1.000
71064455|NCT00502242|141637639|SUPERIORITY_OR_OTHER|||||||0.753|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||||||0.753
71064456|NCT00502242|141637640|SUPERIORITY_OR_OTHER|||||||0.224|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline||||0.224
71064457|NCT00502242|141637640|SUPERIORITY_OR_OTHER|||||||0.179|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL||||0.179
71064458|NCT00502242|141637640|SUPERIORITY_OR_OTHER|||||||0.604|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On-Therapy||||0.604
71064459|NCT00502242|141637640|SUPERIORITY_OR_OTHER|||||||0.486|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off-Therapy||||0.486
71078437|NCT03597139|141664896|SUPERIORITY||Mean Difference (Final Values)|11.6||||0.6362|TWO_SIDED|95.0|-37.0|60.3|||ANCOVA|||||60.3|-37|0.6362
71078438|NCT03597139|141664897|SUPERIORITY||Mean Difference (Final Values)|9.6||||0.0961|TWO_SIDED|95.0|-1.7|20.9||Frequency|ANCOVA|||Frequency||20.9|-1.7|0.0961
71064460|NCT02104219|141637667|SUPERIORITY_OR_OTHER|||||||0.0755|TWO_SIDED|||||The p-value is based on a nonparametric sign test used to determine whether the median RGI-C score differs from 0 for each time interval. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||Pairs of radiographs were centrally evaluated by 3 independent, blinded pediatric radiologists trained in the assessment of the skeletal manifestations of HPP. The mean RGI-C score across the 3 radiologists was calculated and served as the patient's RGI-C score for a specific time point||||0.0755
71064461|NCT02104219|141637668|SUPERIORITY_OR_OTHER|||||||0.6344|TWO_SIDED|||||The p-value is based on a nonparametric sign test used to determine whether the median change in height Z-score from baseline to last assessment differs from 0. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||The earliest documented height measurement that was abstracted within the period from 5 to 15 years of age, inclusive, was defined as the baseline height. Height measurements were assigned to Z-scores calculated using Centers for Disease Control and Prevention 2000 growth charts and methodology. Changes in height Z-score from Baseline were computed by subtracting baseline height Z-score from post baseline height Z-scores. The post baseline time points were grouped by time intervals.||||0.6344
71064462|NCT02104219|141637669|SUPERIORITY_OR_OTHER|||||||0.452|TWO_SIDED|||||The p-value is based on a nonparametric sign test used to determine whether the median change in weight Z-score from baseline to last assessment differs from 0. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||The earliest documented weight measurement that was abstracted within the period from 5 to 15 years of age, inclusive, was defined as the baseline weight. Weight measurements were assigned to Z-scores calculated using Centers for Disease Control and Prevention 2000 growth charts and methodology. Changes in weight Z-score from Baseline were computed by subtracting baseline weight Z-score from post baseline weight Z-scores. The post baseline time points were grouped by time intervals.||||0.4520
71064463|NCT02104219|141637670|SUPERIORITY_OR_OTHER|||||||0.4545|TWO_SIDED|||||The p-value is based on a nonparametric sign test used to determine whether change from baseline in the median RSS score differs from 0 for each time interval. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||The Baseline x-ray set defined for RGI-C, which was compared with its subsequent x-ray sets, was also used as the Baseline x-ray set for the RSS reading. Changes from Baseline were computed based on this baseline RSS score, and postbaseline time points were grouped by intervals of time from Baseline.||||0.4545
71064464|NCT01339260|141637687|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.001|TWO_SIDED|95.0|1.16|1.87||If superiority of netupitant/palonosetron was established for the CR delayed, CR acute and then CR overall at cycle 1 were to be tested according to a hierarchical procedure;no adjustment for multiplicity was needed.The a priori threshold was 0.050|Cochran-Mantel-Haenszel||Cochran Mantel Haenszel (CMH) test including treatment, age class and region as strata. All missing data were to be imputed as treatment failures.|The null hypothesis was rejected if the 2 sided p value from the Cochran Mantel Haenszel test was less than or equal to 0.050 and in the right direction i.e., the Odds Ratio (OR) was in favor of netupitant/palonosetron. Power was 90%.||1.87|1.16|0.001
71064465|NCT01339260|141637688|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.047|TWO_SIDED|95.0|1.0|1.87||If the null hypothesis for CR delayed was rejected, analysis of the first key secondary endpoint CR acute was to be performed. Since the analysis was performed according to a hierarchical procedure, no further adjustment for multiplicity was needed.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test including treatment, age class and region as strata. All missing data were to be imputed as treatment failures.||CR in the acute phase was to be tested using the same 2 sided CMH test as for the primary endpoint. netupitant/palonosetron combination was to be considered superior to palonosetron in the acute phase if the 2 sided p value from the CMH was less than or equal to 0.050 and in the right direction.||1.87|1.0|0.047
71064466|NCT01339260|141637689|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.001|TWO_SIDED|95.0|1.17|1.85||If the null hypothesis for CR acute was rejected, analysis of the 2nd key secondary endpoint CR overall was to be performed. Since the analysis was performed according to a hierarchical procedure, no further adjustment for multiplicity was needed.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test including treatment, age class and region as strata. All missing data were to be imputed as treatment failures.||CR in the overall phase was to be tested using the same 2 sided CMH test as for the primary endpoint. netupitant/palonosetron combination was to be considered superior to palonosetron in the overall phase if the 2 sided p value from the CMH was less than or equal to 0.050 and in the right direction.||1.85|1.17|0.001
71064467|NCT03137160|141637690|SUPERIORITY|||||||1|||||||Fisher Exact|||This is the Investigator Global Assessment comparing the proportion of subjects who achieved a 2 pt reduction at study close (0).||||1
71064468|NCT03448419|141637701|SUPERIORITY||Median difference (HL-estimate)|-4.0||||0.4236|TWO_SIDED|95.0|-16.0|6.0|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodge-Lehman (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of placebo and the effect of empagliflozin.||6.0|-16.0|0.4236
71064469|NCT03448419|141637702|SUPERIORITY||Median difference (HL-estimate)|3.13||||0.0893|TWO_SIDED|95.0|0.0|7.29|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodge-Lehman (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of placebo and the effect of empagliflozin.||7.29|0.00|0.0893
71064470|NCT03448419|141637703|SUPERIORITY||Median Difference (HL-estimate)|0.1||||0.4702|TWO_SIDED|95.0|-0.2|0.4|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodge-Lehman (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of placebo and the effect of empagliflozin.||0.40|-0.20|0.4702
71064471|NCT03448419|141637704|SUPERIORITY||Median difference (HL-estimate)|0.0||||0.983|TWO_SIDED|95.0|-9.0|9.0|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodge-Lehman (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of placebo and the effect of empagliflozin.||9.0|-9.0|0.9830
71064472|NCT03448419|141637705|OTHER||Difference of adjusted means|-0.31||||0.0053|TWO_SIDED|95.0|-0.53|-0.09|||Mixed Model repeated Measures (MMRM)|Covariates: visit-by-treatment interaction, baseline-by-visit interaction. Unstructured covariance structure was used to model within-patient errors.||||-0.09|-0.53|0.0053
71064473|NCT03448419|141637706|OTHER|||||||0.6189|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.6189
71064474|NCT03448419|141637707|OTHER|||||||0.6672|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.6672
71064475|NCT03448419|141637708|OTHER|||||||0.5147|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.5147
71064476|NCT03448419|141637709|OTHER|||||||0.863|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.8630
71064477|NCT03448419|141637710|OTHER||Adjusted geometric mean ratio|0.91||||0.141|TWO_SIDED|95.0|0.81|1.03|||Mixed Model repeated Measures (MMRM)|Covariates: NT-proBNP-by-visit interaction and visit-by-treatment interaction. Unstructured covariance structure to model within-patient errors.|Adjusted geometric mean ratio \[Empagliflozin/Placebo\] of relative change to baseline.|The endpoint 'relative change from baseline in NT-proBNP at Week 12' (after log-transformation) was evaluated using an MMRM analysis over time with baseline log-transformed NT-proBNP-by-visit interaction and visit-by-treatment interaction as covariates.Unstructured covariance structure was used to model within-patient errors.||1.03|0.81|0.1410
71064478|NCT04548193|141637740|SUPERIORITY||Mean Difference (Final Values)|6.14||||0.28|TWO_SIDED|95.0|-5.72|17.99|||Wilcoxon (Mann-Whitney)|||||17.99|-5.72|0.28
71064479|NCT04548193|141637741|SUPERIORITY||Mean Difference (Final Values)|0.72||||0.0054|TWO_SIDED|95.0|0.06|1.38|||Wilcoxon (Mann-Whitney)|||||1.38|0.06|.0054
71064480|NCT04548193|141637743|SUPERIORITY||Mean Difference (Final Values)|0.94||||0.0098|TWO_SIDED|95.0|0.24|1.65|||Wilcoxon (Mann-Whitney)|||||1.65|0.24|.0098
71064481|NCT00630825|141637744|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71064482|NCT00630825|141637744|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71064483|NCT00630825|141637744|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71064484|NCT00630825|141637745|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71064485|NCT00630825|141637745|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71064486|NCT00630825|141637745|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71064487|NCT00630825|141637746|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71064488|NCT00630825|141637746|SUPERIORITY_OR_OTHER|||||||0.047||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.047
71064489|NCT00630825|141637746|SUPERIORITY_OR_OTHER|||||||0.025||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.025
71064490|NCT00630825|141637747|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 4. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71064491|NCT00630825|141637747|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 4. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71064492|NCT00630825|141637747|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 4. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71064493|NCT00630825|141637747|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 8. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71064494|NCT00630825|141637747|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 8. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71064495|NCT00630825|141637747|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 8. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71064496|NCT00630825|141637747|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71064497|NCT00630825|141637747|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71064498|NCT00630825|141637747|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71064499|NCT00630825|141637748|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of HOMA2-%B. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71064500|NCT00630825|141637748|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of HOMA2-%B. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71064501|NCT00630825|141637748|SUPERIORITY_OR_OTHER|||||||0.004||||||Treatment comparison of HOMA2-%B. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.004
71064502|NCT00630825|141637748|SUPERIORITY_OR_OTHER|||||||0.904||||||Treatment comparison of HOMA2-%S. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.904
71064503|NCT00630825|141637748|SUPERIORITY_OR_OTHER|||||||0.138|||||||ANCOVA|Treatment comparison of HOMA2-%S. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.||||||0.138
71064504|NCT00630825|141637748|SUPERIORITY_OR_OTHER|||||||0.729||||||Treatment comparison of HOMA2-%S. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.729
71064505|NCT00630825|141637750|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 4 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71064506|NCT00630825|141637750|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 4 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71064507|NCT00630825|141637750|SUPERIORITY_OR_OTHER|||||||0.113||||||Treatment comparison at 4 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.113
71064508|NCT00630825|141637750|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 8 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71064509|NCT00630825|141637750|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 8 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71064510|NCT00630825|141637750|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 8 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71064511|NCT00630825|141637750|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 16 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71064512|NCT00630825|141637750|SUPERIORITY_OR_OTHER|||||||0.004||||||Treatment comparison at 16 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.004
71064513|NCT00630825|141637750|SUPERIORITY_OR_OTHER|||||||0.001||||||Treatment comparison at 16 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.001
71064514|NCT00630825|141637751|SUPERIORITY_OR_OTHER|||||||0.009||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.009
71064515|NCT00630825|141637751|SUPERIORITY_OR_OTHER|||||||0.028||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.028
71064516|NCT00630825|141637751|SUPERIORITY_OR_OTHER|||||||0.047||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.047
71064517|NCT02211209|141637768|SUPERIORITY||Least Squares Mean Difference|-94.1|||<|0.0001|TWO_SIDED|95.0|-121.7|-66.6|||ANCOVA|||||-66.6|-121.7|< 0.0001
71064518|NCT02211209|141637770|SUPERIORITY||Least Squares Mean Difference|-1804.0|STANDARD_ERROR_OF_MEAN|251.0|<|0.0001|TWO_SIDED|95.0|-2306.0|-1302.0|||ANCOVA|||||-1302|-2306|< 0.0001
71064519|NCT02211209|141637771|SUPERIORITY||Odds Ratio (OR)|186.16||||0.0001|TWO_SIDED|95.0|12.86||NA indicates that the upper limit of 95% CI was not estimable. The upper limit of the odds ratio estimate from the logistic regression model was \>999.999, and it was reported as NA per statistical reporting convention.||Regression, Logistic||||||12.86|0.0001
71064520|NCT02211209|141637772|SUPERIORITY||Odds Ratio (OR)|99.69|||<|0.0001|TWO_SIDED|95.0|15.75|631.06|||Regression, Logistic|||||631.06|15.75|<0.0001
71064521|NCT02211209|141637774|SUPERIORITY|||||||0.6131|||||||t-test, 2 sided|||||||0.6131
71064522|NCT02211209|141637775|SUPERIORITY||Least Squares Mean Difference|138.0||||0.1206|TWO_SIDED|95.0|-36.0|312.0|||ANCOVA|||||312|-36|0.1206
71064523|NCT02792062|141637776|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|113.06||||0.659|TWO_SIDED|90.0|70.37|181.67|||Mixed Models Analysis|||Mixed effect model with natural log-transformed Cmax of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value before breakfast - value in fasted condition without breakfast).||181.67|70.37|0.659
71064524|NCT02792062|141637776|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|45.43||||0.012|TWO_SIDED|90.0|27.86|74.07|||Mixed Models Analysis|||Mixed effect model with natural log-transformed Cmax of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value after breakfast - value in fasted condition without breakfast).||74.07|27.86|0.012
71064525|NCT02792062|141637777|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|84.28||||0.238|TWO_SIDED|90.0|66.09|107.47|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUC∞ of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value before breakfast - value in fasted condition without breakfast).||107.47|66.09|0.238
71064526|NCT02792062|141637777|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|53.2|||<|0.001|TWO_SIDED|90.0|41.39|68.37|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUC∞ of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value after breakfast - value in fasted condition without breakfast).||68.37|41.39|<0.001
71064527|NCT02792062|141637778|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|84.68||||0.256|TWO_SIDED|90.0|66.23|108.27|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUC(0-120) of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value before breakfast - value in fasted condition without breakfast).||108.27|66.23|0.256
71078439|NCT03597139|141664897|SUPERIORITY||Mean Difference (Final Values)|7.7||||0.1722|TWO_SIDED|95.0|-3.4|18.7|||ANCOVA|||Severity||18.7|-3.4|0.1722
71078440|NCT03597139|141664898|SUPERIORITY||Mean Difference (Final Values)|5.2||||0.0051|TWO_SIDED|95.0|1.6|8.9||Left Eye|ANCOVA|||Left Eye||8.9|1.6|0.0051
71064528|NCT02792062|141637778|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|52.56|||<|0.001|TWO_SIDED|90.0|40.78|67.74|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUC(0-120) of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value after breakfast - value in fasted condition without breakfast).||67.74|40.78|<0.001
71064529|NCT02792062|141637779|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|84.68||||0.256|TWO_SIDED|90.0|66.23|108.27|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUClast of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value before breakfast - value in fasted condition without breakfast).||108.27|66.23|0.256
71064530|NCT02792062|141637779|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|52.56|||<|0.001|TWO_SIDED|90.0|40.78|67.74|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUClast of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value after breakfast - value in fasted condition without breakfast).||67.74|40.78|<0.001
71064531|NCT02282813|141637839|SUPERIORITY_OR_OTHER|||||||0.1041|||||||Cochran-Mantel-Haenszel|||||||0.1041
71064532|NCT02282813|141637840|SUPERIORITY_OR_OTHER|||||||0.0503|||||||Cochran-Mantel-Haenszel|||||||.0503
71064533|NCT02282813|141637841|SUPERIORITY_OR_OTHER|||||||0.4817|||||||Cochran-Mantel-Haenszel|||||||0.4817
71064534|NCT02282813|141637842|SUPERIORITY_OR_OTHER|||||||0.8086|||||||Cochran-Mantel-Haenszel|||||||0.8086
71064535|NCT01514292|141637843|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Fisher Exact|||"Hence, the hypothesis is established as:~Ho: pi \< 71.5% Ha: pi \>71.5% Thus, the objective is to conclude that the proportion of G4 Sensor-YSI points in the present study meeting the 20 mg/dL/20% criterion is no worse than the existing FDA-approved SEVEN PLUS System. The null hypothesis will be rejected if pi observed in this study is greater than 71.5%, the G4 System performance is no worse than the historical performance of the existing FDA approved CGM system will be concluded."||||0.0001
71064536|NCT02220764|141637845|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Log Rank|||Null hypothesis: The chipping rates between tooth- and implant- supoorted FDPs are equally distributed.||||0.03
71064537|NCT05000164|141637847|SUPERIORITY||Least-square Mean|-0.12|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.17|-0.07|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|The upper limit of each 95% confidence interval was compared to 0.0 logMAR for distance.|Distance (4m)||-0.07|-0.17|
71064538|NCT05000164|141637847|SUPERIORITY||Least-square Mean|-0.01|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|95.0|-0.06|0.04|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|The upper limit of each 95% confidence interval was compared to 0.17 logMAR for intermediate.|Intermediate (64cm)||0.04|-0.06|
71064539|NCT05000164|141637847|SUPERIORITY||Least-square Mean|0.09|STANDARD_ERROR_OF_MEAN|0.024|||TWO_SIDED|95.0|0.04|0.15|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|The upper limit of each 95% confidence interval was compared to 0.17 logMAR for near.|Near (40cm)||0.15|0.04|
71064540|NCT03493854|141637848|NON_INFERIORITY|The null hypothesis could be rejected and non-inferiority concluded if the lower bound of the 90% confidence interval of the geometric mean ratio was ≥0.8.|Geometric Mean Ratio|1.22|||||TWO_SIDED|90.0|1.14|1.31|||||The CtroughSC/CtroughIV geometric mean ratio was calculated as the SC dose of pertuzumab (Arm B) relative to the pertuzumab IV dose (Arm A).|The null hypothesis was that the pertuzumab Arm A SC dose is inferior to the pertuzumab Arm B IV dose (i.e., the CtroughSC/CtroughIV geometric mean ratio of the SC dose of pertuzumab relative to the IV dose is not greater than 0.8).||1.31|1.14|
71064541|NCT03493854|141637849|NON_INFERIORITY|The null hypothesis could be rejected and non-inferiority concluded if the lower bound of the 90% confidence interval of the geometric mean ratio was ≥0.8. Non-inferiority was tested in hierarchical order after the primary outcome measure, to adjust for multiple statistical testing and control the type I error at one sided 5% significance level.|Geometric Mean Ratio|1.33|||||TWO_SIDED|90.0|1.24|1.43|||||The CtroughSC/CtroughIV geometric mean ratio was calculated as the SC dose of trastuzumab (Arm B) relative to the trastuzumab IV dose (Arm A).|The null hypothesis was that the trastuzumab Arm B SC dose is inferior to the Arm A trastuzumab IV dose (i.e., the CtroughSC/CtroughIV geometric mean ratio of the SC dose of trastuzumab relative to the IV dose is not greater than 0.8).||1.43|1.24|
71064542|NCT03493854|141637850|OTHER|Descriptive analysis only. tpCR was analyzed outside of a hypothesis-testing framework and according to the methodology outlined in the outcome measure description.|Difference in tpCR Rate|0.15|||||TWO_SIDED|95.0|-8.67|8.97|||||Difference in tpCR rate was calculated as Arm B: PH FDC SC minus Arm A: P+H IV.|||8.97|-8.67|
71064543|NCT03493854|141637851|OTHER|Descriptive analysis only|Hazard Ratio (HR)|1.2||||0.5216|TWO_SIDED|95.0|0.68|2.11|||Log Rank|||||2.11|0.68|0.5216
71064544|NCT03493854|141637852|OTHER|Descriptive analysis only|Hazard Ratio (HR)|1.15||||0.5992|TWO_SIDED|95.0|0.68|1.97|||Log Rank|||||1.97|0.68|0.5992
71064545|NCT03493854|141637853|OTHER|Descriptive analysis only|Hazard Ratio (HR)|1.2||||0.4844|TWO_SIDED|95.0|0.72|1.98|||Log Rank|||||1.98|0.72|0.4844
71064546|NCT03493854|141637854|OTHER|Descriptive analysis only|Hazard Ratio (HR)|1.16||||0.5474|TWO_SIDED|95.0|0.71|1.88|||Log Rank|||||1.88|0.71|0.5474
71064547|NCT03493854|141637855|OTHER|Descriptive analysis only|Hazard Ratio (HR)|1.17||||0.6291|TWO_SIDED|95.0|0.61|2.24|||Log Rank|||||2.24|0.61|0.6291
71064548|NCT03493854|141637856|OTHER|Descriptive analysis only|Hazard Ratio (HR)|1.26||||0.5609|TWO_SIDED|95.0|0.58|2.72|||Log Rank|||||2.72|0.58|0.5609
70852634|NCT05498701|141194255|OTHER||Ratio of Adjusted Geometric Means|81.0||||||90.0|76.25|86.04||||||Bioequivalence of the Test treatment (Tafamidis free acid 12.2 mg oral tablet \[Fasted\]) to Reference treatment (Tafamidis meglumine 20 mg oral capsule \[Fasted\]) was concluded if the 90% confidence intervals for the ratios of adjusted geometric means for tafamidis Cmax fell entirely within the acceptance region of (80%,125%).||86.04|76.25|
71064549|NCT02105987|141637909|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is -10%.|Mean Difference (Net)|-3.4|||||TWO_SIDED|95.0|-9.1|2.4|||Cochran-Mantel-Haenszel||Based on Cochran-Mantel Haenszel stratified analysis adjusting for the following Baseline stratification factor: Original ART third agent class (PI, NNRTI, or INI).|||2.4|-9.1|
71064550|NCT02105987|141637911|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-2.0|1.4|||Cochran-Mantel-Haenszel||Based on Cochran-Mantel Haenszel stratified analysis adjusting for the following Baseline stratification factor: Original ART third agent class (PI, NNRTI, or INI).|||1.4|-2.0|
70937883|NCT00264576|141375539|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination geometric mean titers (GMTs) had to be \>0.5.|Ratio of GMT|0.92|||||TWO_SIDED|95.0|0.76|1.12|||ANOVA|||"The following hypotheses were tested for A/H1N1 strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.12|0.76|
71064551|NCT02105987|141637916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.096|TWO_SIDED|95.0|-0.02|0.23|||ANCOVA||Statistical analysis of cholesterol is presented|||0.23|-0.02|0.096
71064552|NCT02105987|141637916|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.07||||0.167|TWO_SIDED|95.0|-0.03|0.18|||ANCOVA||Statistical analysis of LDL cholesterol is presented|||0.18|-0.03|0.167
71064553|NCT02105987|141637916|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.02||||0.317|TWO_SIDED|95.0|-0.02|0.06|||ANCOVA||Statistical analysis of HDL cholesterol is presented|||0.06|-0.02|0.317
71064554|NCT02105987|141637916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.187|TWO_SIDED|95.0|-0.05|0.27|||ANCOVA||Statistical analysis of triglycerides is presented|||0.27|-0.05|0.187
71064555|NCT02105987|141637917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.175|TWO_SIDED|95.0|-0.04|0.25|||ANCOVA||Statistical analysis of total cholesterol/HDL cholesterol ratio is presented|||0.25|-0.04|0.175
71111214|NCT02948582|141728890|SUPERIORITY||least squares mean|0.202|||<|0.0001|TWO_SIDED|95.0|0.165|0.239|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC0\_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.239|0.165|<0.0001
71111215|NCT02948582|141728890|SUPERIORITY||least squares mean|0.199|||<|0.0001|TWO_SIDED|95.0|0.162|0.235|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC0\_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.235|0.162|<0.0001
70852635|NCT01763996|141194273|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8||||0.756|TWO_SIDED|95.0|-10.1|13.76||0.05 level of significance|ANOVA|Analysis of variance (ANOVA) model that includes sequence, period, and treatment as fixed factors and subjects within sequence as a random factor.||||13.76|-10.10|0.756
71064556|NCT02105987|141637918|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.4|||<|0.001|TWO_SIDED|95.0|1.3|3.5|||ANCOVA||Statistical analysis for total score is presented|||3.5|1.3|<0.001
71064557|NCT02105987|141637918|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0||||0.002|TWO_SIDED|95.0|0.4|1.7|||ANCOVA||Statistical analysis for general satisfaction/clinical subscale score is presented|||1.7|0.4|0.002
71064558|NCT02105987|141637918|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|||<|0.001|TWO_SIDED|95.0|0.8|1.8|||ANCOVA||Statistical analysis for lifestyle/ease subscale is presented|||1.8|0.8|<0.001
71064559|NCT02105987|141637919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.51|||<|0.001|TWO_SIDED|95.0|4.86|8.16|||ANCOVA|||||8.16|4.86|<0.001
71064560|NCT02105987|141637920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.87|||<|0.001|TWO_SIDED|95.0|-8.64|-5.11|||ANCOVA|||||-5.11|-8.64|<0.001
71064561|NCT02105987|141637921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|||<|0.001|TWO_SIDED|95.0|-0.17|-0.1|||ANCOVA|||||-0.10|-0.17|<0.001
71064562|NCT02105987|141637922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.375|TWO_SIDED|95.0|-0.31|0.12|||ANCOVA|||||0.12|-0.31|0.375
71064563|NCT02105987|141637923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.749|TWO_SIDED|95.0|-0.93|1.3|||ANCOVA|||||1.30|-0.93|0.749
71064564|NCT02105987|141637924|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.86|||<|0.001|TWO_SIDED|95.0|0.82|0.9||Bone specific alkaline phosphatase|ANCOVA|||||0.90|0.82|<0.001
71064565|NCT02105987|141637924|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.91||||0.002|TWO_SIDED|95.0|0.85|0.96||Osteocalcin|ANCOVA|||||0.96|0.85|0.002
71064566|NCT02105987|141637924|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|-0.09||||0.001|TWO_SIDED|95.0|-0.15|-0.04||Procollagen 1 n-terminal propeptide|ANCOVA|||||-0.04|-0.15|0.001
71064567|NCT02105987|141637924|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.91||||0.001|TWO_SIDED|95.0|0.86|0.96||Type I collagen c-telopeptides|ANCOVA|||||0.96|0.86|0.001
71064568|NCT02105987|141637925|SUPERIORITY_OR_OTHER||Geometric Mean ratio|0.64|||<|0.001|TWO_SIDED|95.0|0.57|0.72||Fatty acid binding protein 2|ANCOVA|||||0.72|0.57|<0.001
71064569|NCT02105987|141637925|SUPERIORITY_OR_OTHER||Geometric Mean ratio|1.08||||0.311|TWO_SIDED|95.0|0.93|1.24||Interleukin 6|ANCOVA|||||1.24|0.93|0.311
71064570|NCT02105987|141637925|SUPERIORITY_OR_OTHER||Geometric Mean ratio|0.92|||<|0.001|TWO_SIDED|95.0|0.89|0.96||Soluble CD14|ANCOVA|||||0.96|0.89|<0.001
71064571|NCT02105987|141637925|SUPERIORITY_OR_OTHER||Geometric Mean ratio|1.01||||0.742|TWO_SIDED|95.0|0.95|1.08||Soluble vasc cell adhesion molecule 1|ANCOVA|||||1.08|0.95|0.742
71064572|NCT02105987|141637926|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0||||0.999|TWO_SIDED|95.0|0.84|1.19|||ANCOVA|||||1.19|0.84|0.999
71064573|NCT02105987|141637927|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0||||0.981|TWO_SIDED|95.0|0.91|1.1|||ANCOVA|||||1.10|0.91|0.981
71064574|NCT02105987|141637928|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.97||||0.64|TWO_SIDED|95.0|0.85|1.11|||ANCOVA|||||1.11|0.85|0.640
71064575|NCT02105987|141637929|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.97||||0.645|TWO_SIDED|95.0|0.87|1.09|||ANCOVA|||||1.09|0.87|0.645
71111216|NCT02948582|141728891|SUPERIORITY||least squares mean|0.058||||0.0028|TWO_SIDED|95.0|0.021|0.095|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC12\_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.095|0.021|0.0028
71064576|NCT02105987|141637930|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.01||||0.577|TWO_SIDED|95.0|0.97|1.06|||ANCOVA|||||1.06|0.97|0.577
71064577|NCT02105987|141637931|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.01||||0.687|TWO_SIDED|95.0|0.98|1.03|||ANCOVA|||||1.03|0.98|0.687
71064578|NCT01262872|141637937|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|-7.9|||||TWO_SIDED|95.0|-36.3|14.6||||||VE-10PP-LD 3+0d vs Synflorix 3+0d - 1M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, one month (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||14.6|-36.3|
71064579|NCT01262872|141637937|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|6.4|||||TWO_SIDED|95.0|-17.8|25.7||||||VE-10PP-LD 3+0d vs Synflorix 3+0d - 5M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, five months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||25.7|-17.8|
71064580|NCT01262872|141637937|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|2.5|||||TWO_SIDED|95.0|-22.6|22.5||||||VE-10PP-LD 3+0d vs Synflorix 3+0d - 8M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, eight months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||22.5|-22.6|
71064581|NCT01262872|141637937|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|4.5|||||TWO_SIDED|95.0|-21.4|25.0||||||VE-10PP-HD 3+0d vs Synflorix 3+0d - 1M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, one month (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||25.0|-21.4|
71064582|NCT01262872|141637937|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|5.3|||||TWO_SIDED|95.0|-19.2|24.8||||||VE-10PP-HD 3+0d vs Synflorix 3+0d - 5M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, five months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||24.8|-19.2|
71064583|NCT01262872|141637937|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|0.6|||||TWO_SIDED|95.0|-24.9|20.9||||||VE-10PP-HD 3+0d vs Synflorix 3+0d - 8M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, eight months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||20.9|-24.9|
71064584|NCT01262872|141637938|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE (see above)|6.6|||||TWO_SIDED|95.0|-18.2|26.2||||||VE-10PP-HD 2+1d vs Synflorix 2+1d - 1M post-Dose 2. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, one month (M) post-dose 2 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||26.2|-18.2|
71111217|NCT02948582|141728891|SUPERIORITY||least squares mean|0.1|||<|0.0001|TWO_SIDED|95.0|0.063|0.137|||least squares mena|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC12\_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.137|0.063|<0.0001
71111218|NCT02948582|141728891|SUPERIORITY||least squares mean|0.105|||<|0.0001|TWO_SIDED|95.0|0.068|0.142|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC12\_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.142|0.068|<0.0001
70852636|NCT00993226|141194284|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_DEVIATION|0.29||0.467|TWO_SIDED|95.0|-0.79|0.36|||t-test in ANOVA model|||Exploratory comparison between SABER-Bupivacaine and Bupivacaine HCl not analyzed inferentially||0.36|-0.79|0.467
71111219|NCT02948582|141728891|SUPERIORITY||least squares mean|0.135|||<|0.0001|TWO_SIDED|95.0|0.098|0.173|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC12\_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.173|0.098|<0.0001
70937884|NCT00264576|141375539|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination geometric mean titers (GMTs) had to be \>0.5.|Ratio of GMT|0.61|||||TWO_SIDED|95.0|0.5|0.75|||ANOVA|||"The following hypotheses were tested for A/H3N2 strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||0.75|0.50|
70937885|NCT00264576|141375539|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination geometric mean titers (GMTs) had to be \>0.5.|Ratio of GMT|1.31|||||TWO_SIDED|95.0|1.09|1.57|||ANOVA|||"The following hypotheses were tested for B strain as measured by cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.57|1.09|
70937886|NCT00264576|141375545|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|0.85|||||TWO_SIDED|95.0|0.7|1.03|||ANCOVA|||"The following hypotheses were tested for A/H1N1 strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.03|0.70|
70937887|NCT00264576|141375545|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|0.63|||||TWO_SIDED|95.0|0.52|0.76|||ANCOVA|||"The following hypotheses were tested for A/H3N2 strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||0.76|0.52|
70941761|NCT04748445|141383935|OTHER||Slope|0.0005126|STANDARD_ERROR_OF_MEAN|4.289||0.2343|TWO_SIDED|90.0|-0.0001981|0.001223|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 11 (The statistical data given below have exponential factor in addition to the values mentioned. For ldispersion value it was 10\^-4).||0.001223|-0.0001981|0.2343
71064585|NCT01262872|141637938|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE (see above)|6.3|||||TWO_SIDED|95.0|-18.0|25.7||||||VE-10PP-HD 2+1d vs Synflorix 2+1d - 5M post-Dose 2. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, five months (M) post-dose 2 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||25.7|-18.0|
71064586|NCT01262872|141637938|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE (see above)|-3.5|||||TWO_SIDED|95.0|-29.3|17.2||||||VE-10PP-HD 2+1d vs Synflorix 2+1d - 3M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, three months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||17.2|-29.3|
71064587|NCT01420068|141638052|SUPERIORITY||Mean Difference (Net)|0.31||||0.84|TWO_SIDED|95.0|-2.74|3.37||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and hypertension etiology (primary, secondary) as factors, and Baseline weight as covariates.||||3.37|-2.74|0.840
71064588|NCT01420068|141638053|SUPERIORITY||Mean Difference (Net)|0.69||||0.303|TWO_SIDED|95.0|-0.63|2.02||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and hypertension etiology (primary, secondary) as factors, and Baseline height as covariates.||||2.02|-0.63|0.303
71064589|NCT01420068|141638054|SUPERIORITY||Mean Difference (Net)|0.03||||0.957|TWO_SIDED|95.0|-1.06|1.12||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and hypertension etiology (primary, secondary) as factors, and Baseline BMI as covariates.||||1.12|-1.06|0.957
71064590|NCT01420068|141638056|SUPERIORITY||Mean Difference (Net)|0.02||||0.992|TWO_SIDED|95.0|-3.29|3.33||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline weight as covariates||Primary Hypertension group (at LT Visit 18 \[Week 104\])||3.33|-3.29|0.992
71064591|NCT01420068|141638056|SUPERIORITY||Mean Difference (Net)|-3.06||||0.215|TWO_SIDED|95.0|-8.22|2.1||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline weight as covariates.||Secondary hypertension group (at LT Visit 19 \[Week 156\])||2.10|-8.22|0.215
71064592|NCT01420068|141638057|SUPERIORITY||Mean Difference (Net)|0.62||||0.403|TWO_SIDED|95.0|-0.85|2.09||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline height as covariates||Primary Hypertension group (at LT Visit 18 \[Week 104\])||2.09|-0.85|0.403
71064593|NCT01420068|141638057|SUPERIORITY||Mean Difference (Net)|0.92||||0.67|TWO_SIDED|95.0|-3.74|5.57||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline height as covariates.||Secondary hypertension group (at LT Visit 19 \[Week 156\])||5.57|-3.74|0.670
70852637|NCT00993226|141194285|SUPERIORITY||LS Mean Difference|-2.51|STANDARD_DEVIATION|2.57||0.331|TWO_SIDED|95.0|-7.59|2.58|||t-test in ANOVA model|||Exploratory comparison between SABER-Bupivacaine and Bupivacaine HCl not analyzed inferentially||2.58|-7.59|0.331
71064594|NCT01420068|141638058|SUPERIORITY||Mean Difference (Net)|-0.11||||0.86|TWO_SIDED|95.0|-1.29|1.08||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline BMI as covariates||Primary Hypertension group (at LT Visit 18 \[Week 104\])||1.08|-1.29|0.860
71064595|NCT01420068|141638058|SUPERIORITY||Mean Difference (Net)|-1.17||||0.32|TWO_SIDED|95.0|-3.66|1.32||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline BMI as covariates.||Secondary hypertension group (at LT Visit 19 \[Week 156\])||1.32|-3.66|0.320
71064596|NCT00758290|141638060|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.05
71064597|NCT01153815|141638074|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Exact Smirnov test|||||||<0.001
71064598|NCT01786993|141638083|SUPERIORITY_OR_OTHER||Event-Free Probability|0.932|||||TWO_SIDED|95.0|0.904|0.951||||||"The hypothesis is formally expressed as:~H0: Freedom from system-related complications through 9 months ≤ 75% Ha: Freedom from system-related complications through 9 months \> 75%"||0.951|0.904|
71064599|NCT01786993|141638084|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a binomial distribution with a 44% probability for non-responders between 3 months and 9 months in both study arms, the sample size required for 85% power to reject the null hypothesis at the 5% significance level is 394. To adjust for a potential net crossover of 15% and an overall attrition rate of 20%, the total number of patients required to be enrolled in this study is 506.|Difference of proportions|-0.049||||0.0131|ONE_SIDED|97.5|-0.138||||normal approximation for binomial dist|||"H0: (Non-responder rate in the BiV arm between 3 M randomization and 9 M) - (Non-responder rate in the MPP arm between 3 M randomization and 9 M) ≤ -0.15~Ha: (Non-responder rate in the BiV arm between 3 M randomization and 9 M) - (Non-responder rate in the MPP arm between 3 M randomization and 9 M) \> -0.15~The null hypothesis will be rejected at the 2.5% significance level if the lower one-sided 97.5% confidence bound for the difference in the proportions is above -0.15."|||-0.138|0.0131
71064600|NCT01890122|141638085|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.107|<|0.0001|TWO_SIDED|95.0|-0.7|-0.278||An analysis of covariance (ANCOVA) model was used with treatment and country as fixed effects, and Baseline HbA1c as a continuous covariate.|ANCOVA|||||-0.278|-0.700|< 0.0001
71064601|NCT01890122|141638085|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.108|<|0.0001|TWO_SIDED|95.0|-0.889|-0.467||An ANCOVA model was used with treatment and country as fixed effects, and Baseline HbA1c as a continuous covariate.|ANCOVA|||||-0.467|-0.889|< 0.0001
71064602|NCT02907177|141638109|SUPERIORITY||Treatment effect (rate ratio)|1.27||||0.5252|TWO_SIDED|95.0|0.608|2.654|||Negative binomial regression||Rate ratio is ponesimod 20 mg / DMF versus placebo /DMF|||2.654|0.608|0.5252
71064603|NCT02505217|141638113|SUPERIORITY|||||||0.007|||||||Regression, Cox|||||||0.007
71064604|NCT01624740|141638121|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||ANOVA|Period effect p=0.11||||||0.74
71064605|NCT02999269|141638122|SUPERIORITY|||||||0.04||||||p-value for time by amplitude interaction|Regression, Linear|||For the primary outcomes (change in HDRS24), we performed a full longitudinal model with an unstructured repeated measures covariance matrix on subjects who completed the study in the assigned treatment arm. The dependent variable was HDRS at each visit and the independent variables included progress (time within the ECT series: pre-, mid-, and post-ECT), amplitude, age, sex, pulse width and the following interactions: progress/amplitude, progress/sex, and progress/pulse width.|Time-by-amplitude interaction (F4, 72 = 2.65, p = 0.04).|||0.04
71064606|NCT02999269|141638122|SUPERIORITY|||||||0.0001|||||||Regression, Linear|||||||0.0001
71064607|NCT02999269|141638123|SUPERIORITY|||||||0.37|||||||Regression, Linear|||||||0.37
71064608|NCT02999269|141638123|SUPERIORITY|||||||0.5||||||p-value is time-by-amplitude interaction|Regression, Linear|||||||0.50
71064609|NCT02999269|141638123|SUPERIORITY||||||<|0.01||||||Progress (F2,71 = 11.15, p \< 0.01)|Regression, Linear|||||||< 0.01
71064610|NCT01102257|141638131|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
71064611|NCT00529087|141638147|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|24.4|||<|0.001||95.0|17.3|31.4|||Chi-squared|||||31.4|17.3|<0.001
71064612|NCT00529087|141638148|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|19.5|||<|0.001||95.0|15.1|24.0|||t-test, 2 sided|||||24.0|15.1|<0.001
71064613|NCT00529087|141638148|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|20.9|||<|0.001||95.0|16.1|25.7|||t-test, 2 sided|||||25.7|16.1|<0.001
71064614|NCT00529087|141638149|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Log Rank|Log-rank test for comparisons of survival distributions||||||<0.001
71064615|NCT00529087|141638150|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|1.6|||<|0.001||95.0|1.1|2.1|||ANCOVA|Treatment as factor and baseline weekly RFBM as covariate||||2.1|1.1|<0.001
71064616|NCT00529087|141638150|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.7||||0.011||95.0|0.2|1.2|||ANCOVA|Treatment as factor and baseline weekly RFBM as covariate||||1.2|0.2|0.011
71064617|NCT00529087|141638152|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|20.4|||<|0.001||95.0|9.5|31.3|||Chi-squared|||||31.3|9.5|<0.001
71064618|NCT00529087|141638152|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|7.0||||0.212||95.0|-4.0|18.0|||Chi-squared|||||18.0|-4.0|0.212
71064619|NCT00529087|141638153|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||The statistical analysis for all time points (1, 2, 3 and 6 hours) is only shown once as the p value is the same for all time points.||||<0.001
71064620|NCT00529087|141638153|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||The statistical analysis for all time points (1, 2, 3 and 6 hours) is only shown once as the p value is the same for all time points.||||<0.001
71064621|NCT00529087|141638154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.5|||<|0.001||95.0|11.2|17.9|||ANOVA|Treatment as a factor||1 hour||17.9|11.2|<0.001
71064622|NCT00529087|141638154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.0|||<|0.001||95.0|4.6|11.4|||ANOVA|Treatment as a factor||1 hour||11.4|4.6|<0.001
71064623|NCT00529087|141638154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.5|||<|0.001||95.0|14.4|22.5|||ANOVA|Treatment as a factor||2 hours||22.5|14.4|<0.001
71064624|NCT00529087|141638154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.4|||<|0.001||95.0|6.3|14.5|||ANOVA|Treatment as a factor||2 hours||14.5|6.3|<0.001
71064625|NCT00529087|141638154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.3|||<|0.001||95.0|15.0|23.5|||ANOVA|Treatment as a factor||3 hours||23.5|15.0|<0.001
71111220|NCT02948582|141728891|SUPERIORITY||least squares mean|0.128|||<|0.0001|TWO_SIDED|95.0|0.091|0.166|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC12\_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.166|0.091|<0.0001
70852638|NCT00791817|141194289|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3897|||||TWO_SIDED|90.0|1.1998|1.6097||||Confidence Interval is on the Ratio of Fed to Fasted|Confidence Interval is on the Ratio of Fed to Fasted|values are Geometric Means and Confidence Intervals are on the Ratio of Fed to Fasted||1.6097|1.1998|
70852639|NCT01134705|141194305|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.84|||<|0.001|TWO_SIDED|95.0|-1.2|-0.5||A priori threshold for statistical significance is p\<0.05|Repeated measures Analysis of covariance|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.5|-1.2|<0.001
70852640|NCT01134705|141194306|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.78|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4||A priori threshold for statistical significance is p\<0.05|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.4|-1.1|<0.001
70852641|NCT01134705|141194307|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58||||0.001|TWO_SIDED|95.0|-0.9|-0.2||A priori threshold for statistical significance is p\<0.05|ANCOVA|ANCOVA with treatment, baseline and center in the model.||||-0.2|-0.9|0.001
70852642|NCT04784442|141194308|SUPERIORITY|The overall Type I error rate will be controlled by performing comparison versus the placebo group starting from the highest ETC 1002 dose group by a closed testing procedure at a two-sided significance level of 0.05.|Least squares mean difference|-19.35|STANDARD_ERROR_OF_MEAN|2.768|<|0.001|TWO_SIDED|95.0|-24.81|-13.88|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-13.88|-24.81|<0.001
70852643|NCT04784442|141194308|SUPERIORITY||Least squares mean difference|-19.93|STANDARD_ERROR_OF_MEAN|2.798|<|0.001|TWO_SIDED|95.0|-25.45|-14.41|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 120 mg arm minus the value for the placebo arm.|||-14.41|-25.45|<0.001
70852644|NCT04784442|141194308|SUPERIORITY||Least squares mean difference|-8.67|STANDARD_ERROR_OF_MEAN|2.813||0.002|TWO_SIDED|95.0|-14.22|-3.12|||ANCOVA||||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|-3.12|-14.22|0.002
70852645|NCT01578850|141194322|SUPERIORITY_OR_OTHER||Difference in Proportions|26.3|||<|0.001|TWO_SIDED|95.0|16.78|35.81|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).|Participants who took rescue therapy had the final value taken before rescue used for analysis at all ensuing time points.|||35.81|16.78|<0.001
70852646|NCT01578850|141194323|SUPERIORITY_OR_OTHER||Difference in proportions|23.7||||0.019|TWO_SIDED|95.0|6.83|40.61|||Cochran-Mantel-Haenszel|The p-value from CMH test of general association was stratified by geographic region.||||40.61|6.83|0.019
70852647|NCT01578850|141194325|SUPERIORITY_OR_OTHER||Difference in proportions|-0.6||||0.371|TWO_SIDED|95.0|-1.76|0.57|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Baseline||0.57|-1.76|0.371
70852648|NCT01578850|141194325|SUPERIORITY_OR_OTHER||Difference in proportions|0.6||||0.358|TWO_SIDED|95.0|-0.59|1.81|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Baseline||1.81|-0.59|0.358
70852649|NCT01578850|141194325|SUPERIORITY_OR_OTHER||Difference in proportions|2.6||||0.667|TWO_SIDED|95.0|-4.76|9.98|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 24||9.98|-4.76|0.667
70852650|NCT01578850|141194325|SUPERIORITY_OR_OTHER||Difference in proportions|21.5||||0.001|TWO_SIDED|95.0|10.99|32.02|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 28||32.02|10.99|0.001
70852651|NCT01578850|141194325|SUPERIORITY_OR_OTHER||Difference in proportions|19.0||||0.004|TWO_SIDED|95.0|8.81|29.1|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 28||29.10|8.81|0.004
70852652|NCT01578850|141194325|SUPERIORITY_OR_OTHER||Difference in proportions|30.8|||<|0.001|TWO_SIDED|95.0|20.79|40.83|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 36||40.83|20.79|<0.001
70852653|NCT01578850|141194325|SUPERIORITY_OR_OTHER||Difference in proportions|27.2|||<|0.001|TWO_SIDED|95.0|16.89|37.54|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 36||37.54|16.89|<0.001
71064626|NCT00529087|141638154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|||<|0.001||95.0|6.7|15.3|||ANOVA|Treatment as a factor||3 hours||15.3|6.7|<0.001
71064627|NCT00529087|141638154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.5|||<|0.001||95.0|15.2|23.9|||ANOVA|Treatment as a factor||4 hours||23.9|15.2|<0.001
71064628|NCT00529087|141638154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|||<|0.001||95.0|6.6|15.4|||ANOVA|Treatment as a factor||4 hours||15.4|6.6|<0.001
71064629|NCT00529087|141638154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.7|||<|0.001||95.0|15.2|24.1|||ANOVA|Treatment as a factor||6 hours||24.1|15.2|<0.001
71064630|NCT00529087|141638154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.7|||<|0.001||95.0|6.2|15.2|||ANOVA|Treatment as a factor||6 hours||15.2|6.2|<0.001
71064631|NCT00529087|141638155|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|21.0|||<|0.001||95.0|10.2|31.9|||Chi-squared|||||31.9|10.2|<0.001
71064632|NCT00529087|141638155|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|5.6||||0.316||95.0|-5.3|16.5|||Chi-squared|||||16.5|-5.3|0.316
71064633|NCT00529087|141638156|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|19.7|||<|0.001||95.0|9.4|30.1|||Chi-squared|||||30.1|9.4|<0.001
71064634|NCT00529087|141638156|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|13.3||||0.016||95.0|2.6|24.0|||Chi-squared|||||24.0|2.6|0.016
71064635|NCT00529087|141638157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4|||<|0.001||95.0|1.0|1.9|||ANCOVA|Treatment as factor, Baseline as covariate||||1.9|1.0|<0.001
71064636|NCT00529087|141638157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.102||95.0|-0.1|0.8|||ANCOVA|Treatment as factor, Baseline as covariate||||0.8|-0.1|0.102
71064637|NCT00529087|141638158|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|1.1|||<|0.001||95.0|0.6|1.5|||ANCOVA|||||1.5|0.6|<0.001
71064638|NCT00529087|141638158|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.4|||<|0.001||95.0|0.0|0.9|||ANCOVA|||||0.9|0.0|<0.001
71064639|NCT00529087|141638159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.2|||<|0.001||95.0|0.8|1.6|||ANCOVA|Treatment as factor, Baseline as covariate||||1.6|0.8|<0.001
71064640|NCT00529087|141638159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5||||0.012||95.0|0.1|0.9|||ANCOVA|Treatment as factor, Baseline as covariate||||0.9|0.1|0.012
71111221|NCT03810014|141728904|SUPERIORITY||Risk Difference (RD)|2.5||||0.01|TWO_SIDED|98.0|0.2|4.8|||Generalized estimating equations|||(Arm 3 + Arm 4) vs (Arm 1 + Arm 2)||4.80|0.20|0.01
71111222|NCT03810014|141728904|SUPERIORITY||Risk Ratio, log|1.025||||0.012|TWO_SIDED|98.0|1.002|1.049|||Generalized estimating equations|||(Arm 3 + Arm 4) vs (Arm 1 + Arm 2)||1.049|1.002|0.012
71064641|NCT00529087|141638160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5||||0.002||95.0|0.2|0.7|||ANCOVA|Treatment as factor, Baseline as covariate||||0.7|0.2|0.002
71064642|NCT00529087|141638160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.119||95.0|-0.1|0.5|||ANCOVA|Treatment as factor, Baseline as covariate||||0.5|-0.1|0.119
71064643|NCT00529087|141638161|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-0.3||||0.008||95.0|-0.5|-0.1|||ANCOVA|Treatment as factor, Baseline as covariate||||-0.1|-0.5|0.008
71064644|NCT00529087|141638161|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-0.2||||0.015||95.0|-0.5|0.0|||ANCOVA|Treatment as factor, Baseline as covariate||||0.0|-0.5|0.015
71064645|NCT00529087|141638164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1||||0.731||95.0|-5.4|7.7|||ANCOVA|Treatment as factor, Baseline as covariate||||7.7|-5.4|0.731
71064646|NCT00529087|141638164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.779||95.0|-5.6|7.5|||ANCOVA|Treatment as factor, Baseline as covariate||||7.5|-5.6|0.779
71064647|NCT00529087|141638165|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|5.6||||0.023||95.0|0.8|10.4|||ANCOVA|Treatment as factor, baseline as covariate||||10.4|0.8|0.023
71064648|NCT00529087|141638165|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|2.8||||0.258||95.0|-2.0|7.6|||ANCOVA|Treatment as factor, baseline as covariate||||7.6|-2.0|0.258
71064649|NCT00529087|141638167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.0||||0.071||95.0|-0.6|14.5|||ANCOVA|Treatment as factor, baseline as covariate||||14.5|-0.6|0.071
71064650|NCT00529087|141638167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.6||||0.087||95.0|-1.0|14.2|||ANCOVA|Treatment as factor, baseline as covariate||||14.2|-1.0|0.087
71064651|NCT00529087|141638168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.6||||0.038||95.0|0.4|14.7|||ANCOVA|Treatment as factor, baseline as covariate||||14.7|0.4|0.038
71064652|NCT00529087|141638168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.3||||0.237||95.0|-2.8|11.5|||ANCOVA|Treatment as factor, baseline as covariate||||11.5|-2.8|0.237
71064653|NCT00457002|141638192|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.87||||0.4364|TWO_SIDED|95.0|0.62|1.23|||Mantel Haenszel|||To conclude superiority of apixaban versus enoxaparin on the primary efficacy endpoint, the upper bound of the two-sided 95.004% confidence interval (CI) for the relative risk (pa/ pe) must be less than 1.||1.23|0.62|0.4364
71064654|NCT00457002|141638192|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.39|||||TWO_SIDED|95.0|-1.37|0.59||||||||0.59|-1.37|
71064655|NCT00457002|141638193|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.69|1.63||||||Formal testing of noninferiority for the key secondary efficacy endpoint was not performed since the superiority of the primary efficacy endpoint was not demonstrated.||1.63|0.69|
71064656|NCT00457002|141638193|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.61|0.81||||||||0.81|-0.61|
71064657|NCT00457002|141638194|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.7|1.71||||||||1.71|0.70|
71064658|NCT00457002|141638194|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.14|||||TWO_SIDED|95.0|-0.57|0.85||||||||0.85|-0.57|
71064659|NCT00457002|141638195|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.78|1.2||||||||1.20|0.78|
71064660|NCT00457002|141638195|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.24|||||TWO_SIDED|95.0|-1.65|1.17||||||||1.17|-1.65|
71064661|NCT00457002|141638196|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.79|1.22||||||||1.22|0.79|
71064662|NCT00457002|141638196|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.12|||||TWO_SIDED|95.0|-1.52|1.29||||||||1.29|-1.52|
71064663|NCT00457002|141638197|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.65|1.29||||||||1.29|0.65|
71064664|NCT00457002|141638197|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.26|||||TWO_SIDED|95.0|-1.23|0.71||||||||0.71|-1.23|
71064665|NCT00457002|141638198|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.68|||||TWO_SIDED|95.0|0.11|4.05||||||||4.05|0.11|
71064666|NCT00457002|141638198|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.03|||||TWO_SIDED|95.0|-0.16|0.1||||||||0.10|-0.16|
71064667|NCT00457002|141638199|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.89|||||TWO_SIDED|95.0|0.68|1.16||||||||1.16|0.68|
71111223|NCT03810014|141728904|SUPERIORITY||Risk Difference (RD)|-0.6||||0.33|TWO_SIDED|98.0|-2.2|0.9|||Generalized estimating equations|||(Arm 1 + Arm 3) vs (Arm 2 + Arm 4)||0.90|-2.20|0.33
71111224|NCT03810014|141728904|SUPERIORITY||Risk Ratio, log|0.994||||0.332|TWO_SIDED|98.0|0.979|1.009|||Generalized estimating equations|||(Arm 1 + Arm 3) vs (Arm 2 + Arm 4)||1.009|0.979|0.332
71111225|NCT02148263|141728954|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||||||0.83
71111226|NCT02148263|141728955|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
71111227|NCT02148263|141728956|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||||||.94
71064668|NCT00457002|141638199|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.38|||||TWO_SIDED|95.0|-1.25|0.48||||||||0.48|-1.25|
71064669|NCT00457002|141638200|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5|||||TWO_SIDED|95.0|0.26|0.96||||||||0.96|0.26|
71064670|NCT00457002|141638200|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.4|||||TWO_SIDED|95.0|-0.78|-0.03||||||||-0.03|-0.78|
71064671|NCT00457002|141638201|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.04|||||TWO_SIDED|95.0|0.84|1.28||||||||1.28|0.84|
71064672|NCT00457002|141638201|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.28|||||TWO_SIDED|95.0|-1.18|1.73||||||||1.73|-1.18|
71064673|NCT00457002|141638202|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.32|2.43||||||||2.43|0.32|
71064674|NCT00457002|141638202|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.03|||||TWO_SIDED|95.0|-0.26|0.2||||||||0.20|-0.26|
71064675|NCT00457002|141638203|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.32|2.43||||||||2.43|0.32|
71064676|NCT00457002|141638203|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.03|||||TWO_SIDED|95.0|-0.26|0.2||||||||0.20|-0.26|
71064677|NCT00457002|141638204|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.31|||||TWO_SIDED|95.0|0.11|0.83||||||||0.83|0.11|
71064678|NCT00457002|141638204|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.34|||||TWO_SIDED|95.0|-0.62|-0.07||||||||-0.07|-0.62|
71064679|NCT00457002|141638205|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.65|1.37||||||||1.37|0.65|
71064680|NCT00457002|141638205|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.14|||||TWO_SIDED|95.0|-1.04|0.76||||||||0.76|-1.04|
71064681|NCT00457002|141638206|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.15|||||TWO_SIDED|95.0|-0.29|-0.02||||||Note: Relative risk was not estimable (0.0); only risk difference could be estimated.||-0.02|-0.29|
71064682|NCT00457002|141638207|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.41|||||TWO_SIDED|95.0|0.14|1.16||||||||1.16|0.14|
71064683|NCT00457002|141638207|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.22|||||TWO_SIDED|95.0|-0.47|0.03||||||||0.03|-0.47|
71064684|NCT00457002|141638208|SUPERIORITY_OR_OTHER||Adjusted Difference of event rates|0.29||||0.0437|TWO_SIDED|95.0|0.01|0.57||The Mantel-Haenszel test stratified by the stratification factors will be used at the one-sided alpha=0.025 level.|Mantel Haenszel|||Adjusted difference of event rates takes the stratification factor into consideration: previous VTE (yes, no) and active or previous cancer (yes, no).||0.57|0.01|0.0437
71064685|NCT00457002|141638209|SUPERIORITY_OR_OTHER||Adjusted Difference of event rates|0.36|||||TWO_SIDED|95.0|-0.33|1.06||||||Adjusted difference of event rates takes the stratification factor into consideration: previous VTE (yes, no) and active or previous cancer (yes, no).||1.06|-0.33|
71064686|NCT00457002|141638210|SUPERIORITY_OR_OTHER||Adjustted difference of event rates|0.59|||||TWO_SIDED|95.0|-16.0|1.33||||||Adjusted difference of event rates takes the stratification factor into consideration: previous VTE (yes, no) and active or previous cancer (yes, no).||1.33|-016|
71064687|NCT00457002|141638211|SUPERIORITY_OR_OTHER||Adjusted Difference of Event Rates|0.87|||||TWO_SIDED|95.0|-0.4|2.14||||||||2.14|-0.40|
71064688|NCT00457002|141638212|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.74|1.61||||||||1.61|0.74|
71064689|NCT00457002|141638212|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.2|||||TWO_SIDED|95.0|-0.66|1.07||||||||1.07|-0.66|
71064690|NCT00457002|141638221|SUPERIORITY_OR_OTHER||Adjusted Event rate difference|0.0|||||TWO_SIDED|95.0|-0.3|0.29|||||stratification factor: previous VTE (yes, no), and active or previous cancer (yes, no).|Adjusted difference in event rates in MI or stroke.||0.29|-0.30|
71064691|NCT00457002|141638221|SUPERIORITY_OR_OTHER||Adjusted difference of event rates|0.09|||||TWO_SIDED|95.0|-0.11|0.3|||||stratification factor: previous VTE (yes, no), and active or previous cancer (yes, no).|Adjusted difference of event rates for myocardial infarction.||0.30|-0.11|
71064692|NCT00457002|141638221|SUPERIORITY_OR_OTHER||Adjusted difference in event rates|-0.1|||||TWO_SIDED|95.0|-0.32|0.12||||||Adjusted difference in event rates for stroke.||0.12|-0.32|
71064693|NCT00457002|141638221|SUPERIORITY_OR_OTHER||Adjusted difference in event rates|0.09|||||TWO_SIDED|95.0|-0.09|0.28|||||stratification factor: previous VTE (yes, no), and active or previous cancer (yes, no).|Adjusted difference of event rates in thrombocytopenia.||0.28|-0.09|
71064694|NCT01017874|141638246|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.217|TWO_SIDED|95.0|0.63|1.13|||Wilcoxon (Mann-Whitney)|||||1.13|0.63|0.217
71064695|NCT01017874|141638247|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.788|TWO_SIDED|95.0|0.68|1.31|||Wilcoxon (Mann-Whitney)|||||1.31|0.68|0.788
71064696|NCT01017874|141638250|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.252|TWO_SIDED|95.0|0.63|1.14|||Wilcoxon (Mann-Whitney)|||||1.14|0.63|0.252
71064697|NCT01017874|141638251|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.952|TWO_SIDED|95.0|0.53|1.32|||Wilcoxon (Mann-Whitney)|||||1.32|0.53|0.952
71064698|NCT03809663|141638309|SUPERIORITY||Odds Ratio (OR)|1.686||||0.56|TWO_SIDED|95.0|0.29|9.809||Nominal p-value|Regression, Logistic|||||9.809|0.290|0.56
71064699|NCT03809663|141638309|SUPERIORITY||Odds Ratio (OR)|1.011||||0.99|TWO_SIDED|95.0|0.135|7.551||Nominal p-value|Regression, Logistic|||||7.551|0.135|0.99
71064700|NCT03809663|141638309|SUPERIORITY||Odds Ratio (OR)|2.146||||0.38|TWO_SIDED|95.0|0.39|11.8||Nominal p-value|Regression, Logistic|||||11.800|0.390|0.38
71064701|NCT03809663|141638310|SUPERIORITY||Odds Ratio (OR)|0.982||||0.97|TWO_SIDED|95.0|0.344|2.803||Nominal p-value|Regression, Logistic|||||2.803|0.344|0.97
71064702|NCT03809663|141638310|SUPERIORITY||Odds Ratio (OR)|1.217||||0.7|TWO_SIDED|95.0|0.441|3.356||Nominal p-value|Regression, Logistic|||||3.356|0.441|0.70
71064703|NCT03809663|141638310|SUPERIORITY||Odds Ratio (OR)|0.73||||0.58|TWO_SIDED|95.0|0.243|2.197||Nominal p-value|Regression, Logistic|||||2.197|0.243|0.58
71064704|NCT03309943|141638337|SUPERIORITY|Mixed model analysis examining the effects of drug condition on response to smoking vs. non-smoking cues (collapsed across category - proximal, standard environment, personal environment). Data were analyzed using the underlying raw values versus collapsing them together.||||||0.019|||||||Mixed Models Analysis|Adjusted for FTCD. Carried out using SPSS Mixed Models with a repeated statement and compound symmetry covariance structure.||||||.019
71078441|NCT03597139|141664898|SUPERIORITY||Mean Difference (Final Values)|4.8||||0.0104|TWO_SIDED|95.0|1.1|8.4||Right Eye|ANCOVA|||Right Eye||8.4|1.1|0.0104
70937888|NCT00264576|141375545|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|1.16|||||TWO_SIDED|95.0|0.98|1.38|||ANCOVA|||"The following hypotheses were tested for B strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.38|0.98|
70937889|NCT00264576|141375545|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|0.92|||||TWO_SIDED|95.0|0.76|1.12||To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|ANCOVA|||"The following hypotheses were tested for A/H1N1 strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.12|0.76|
70937890|NCT00264576|141375545|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|0.69|||||TWO_SIDED|95.0|0.57|0.83|||ANCOVA|||"The following hypotheses were tested for A/H3N2 strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||0.83|0.57|
70937891|NCT00264576|141375545|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|1.33|||||TWO_SIDED|95.0|1.13|1.58|||ANCOVA|||"The following hypotheses were tested for B strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.58|1.13|
70937892|NCT02834624|141375568|OTHER||||||<|0.05|||||||t-test, 1 sided|||Sample size calculations used a Chi-square for independence, u = 1, p =.05, power = .80, effect size = .60, which required 22 total subjects.||||<.05
71064705|NCT03309943|141638338|SUPERIORITY|Mixed model analysis examining the effects of drug condition on response to smoking vs. non-smoking cues (collapsed across category - proximal, standard environment, personal environment). Data were analyzed using the underlying raw values versus collapsing them together.||||||0.83|||||||Mixed Models Analysis|Adjusted for FTCD||||||.830
71064706|NCT03309943|141638339|SUPERIORITY|Mixed model analysis examining the effects of drug condition on response to smoking vs. non-smoking cues (collapsed across category - proximal, standard environment, personal environment). Data were analyzed using the underlying raw values versus collapsing them together.||||||0.006|||||||Mixed Models Analysis|||||||.006
70937893|NCT02834624|141375570|OTHER|||||||0.63|||||||t-test, 1 sided|||||||0.63
70937894|NCT00092456|141375571|NON_INFERIORITY_OR_EQUIVALENCE|If equivalence was established in all 3 pairwise comparisons for a given serotype, the 3 lots were considered consistent for that serotype. Each comparison consisted of 2 one-sided tests of equivalence with α=0.05. Statistical significance for the 2 one-sided equivalence tests for each pair of lots was established if the p-values for the hypothesis tests were each less than 0.05. This corresponds to the 2-sided 90% CI for the fold difference in the 2 lots being contained entirely within (0.5,2).|||||<|0.001||95.0||||The reported p-value is for all 5 serotypes, no multiplicity adjustment made, and Type I error rate controlled at the 0.05 level. P\<0.05 implies that the difference is statistically significantly less than the prespecified difference of 2 fold.|ANOVA|||A pairwise comparison of lots was made for each serotype, for each pair of lots.||||<0.001
70937895|NCT00092456|141375571|NON_INFERIORITY_OR_EQUIVALENCE|If equivalence was established in all 3 pairwise comparisons for a given serotype, the 3 lots were considered consistent for that serotype. Each comparison consisted of 2 one-sided tests of equivalence with α=0.05. Statistical significance for the 2 one-sided equivalence tests for each pair of lots was established if the p-values for the hypothesis tests were each less than 0.05. This corresponds to the 2-sided 90% CI for the fold difference in the 2 lots being contained entirely within (0.5,2)|||||<|0.001||95.0||||The reported p-value is for all 5 serotypes, no multiplicity adjustment made, and Type I error rate controlled at the 0.05 level. P\<0.05 implies that the difference is statistically significantly less than the prespecified difference of 2 fold.|ANOVA|||A pairwise comparison of lots was made for each serotype, for each pair of lots.||||<0.001
71064707|NCT03309943|141638340|SUPERIORITY|Mixed model analysis examining the effects of drug condition on response to smoking vs. non-smoking cues (collapsed across category - proximal, standard environment, personal environment). Data were analyzed using the underlying raw values versus collapsing them together.||||||0.653|||||||Mixed Models Analysis|||||||.653
71078442|NCT03597139|141664899|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.0003|TWO_SIDED|95.0|-3.2|-1.0||Left Eye|ANCOVA||Add in RE LE info|Left Eye||-1.0|-3.2|0.0003
71078443|NCT03597139|141664899|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.0038|TWO_SIDED|95.0|-2.6|-0.5||Right Eye|ANCOVA|||Right Eye||-0.5|-2.6|0.0038
71078444|NCT02724410|141664916|OTHER|Chi Square test of independence||||||0.7188|||||||Chi-squared|||||||0.7188
71078445|NCT02724410|141664917|OTHER|Chi Square test of independence||||||0.5933|||||||Chi-squared|||||||.5933
71078446|NCT02724410|141664918|OTHER|Chi Square test of independence|||||>|0.99|||||||Chi-squared|||||||>.99
71078447|NCT02724410|141664919|OTHER|T-test for difference between groups|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<.0001
71078448|NCT00410072|141664958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.9||||0.0882|TWO_SIDED|95.0|-1.0|14.9|||Cochran-Mantel-Haenszel|||Week 96||14.9|-1.0|0.0882
71078449|NCT00410072|141664959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.5|||||TWO_SIDED|95.0|2.3|24.8|||NC=F|||||24.8|2.3|
71078450|NCT00410072|141664959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2|||||TWO_SIDED|95.0|-7.7|12.0|||NC=F|||||12.0|-7.7|
71064708|NCT03309943|141638341|SUPERIORITY|Mixed model analysis examining the effects of drug condition on response to smoking vs. non-smoking cues (collapsed across category - proximal, standard environment, personal environment). Data were analyzed using the underlying raw values versus collapsing them together.||||||0.012|||||||Mixed Models Analysis|Adjusted for FTCD||||||.012
71064709|NCT03309943|141638342|SUPERIORITY|Mixed model analysis examining the effects of drug condition on PPI indexes while viewing proximal smoking cues (which drove activation effects).||||||0.013|||||||Mixed Models Analysis|||||||.013
71064710|NCT03309943|141638343|SUPERIORITY|Repeated Measures ANCOVA analysis examining condition differences (adjusting for FTCD score)||||||0.024|||||||Repeated Measures ANCOVA|Adjusted for FTCD.||||||.024
71064711|NCT03309943|141638344|SUPERIORITY|Repeated Measures ANCOVA analysis examining condition differences (adjusting for FTCD score)||||||0.086|||||||Repeated Measures ANCOVA|Adjusted for FTCD score||||||.086
70937896|NCT00092456|141375571|NON_INFERIORITY_OR_EQUIVALENCE|If equivalence was established in all 3 pairwise comparisons for a given serotype, the 3 lots were considered consistent for that serotype. Each comparison consisted of 2 one-sided tests of equivalence with α=0.05. Statistical significance for the 2 one-sided equivalence tests for each pair of lots was established if the p-values for the hypothesis tests were each less than 0.05. This corresponds to the 2-sided 90% CI for the fold difference in the 2 lots being contained entirely within (0.5,2).|||||<|0.001||95.0||||The reported p-value is for all 5 serotypes, no multiplicity adjustment made, and Type I error rate controlled at the 0.05 level. P\<0.05 implies that the difference is statistically significantly less than the prespecified difference of 2 fold.|ANCOVA|||A pairwise comparison of lots was made for each serotype, for each pair of lots.||||<0.001
70937897|NCT01250717|141375603|SUPERIORITY_OR_OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.12||||||||0.12|0|
71064712|NCT03309943|141638345|SUPERIORITY|Repeated Measures ANCOVA analysis examining condition differences (adjusting for FTCD score)||||||0.14|||||||Repeated Measures ANCOVA|Adjusted for FTCD score||||||.140
71064713|NCT03309943|141638346|SUPERIORITY|Standard ANCOVA analysis examining condition differences (adjusting for baseline craving and FTCD score).||||||0.556|||||||ANCOVA|Adjusted for baseline craving and FTCD score||||||.556
71064714|NCT03309943|141638347|SUPERIORITY|Standard ANCOVA analysis examining condition differences (adjusting for FTCD score).||||||0.463||||||Adjusted for FTCD score only.|ANCOVA|||||||.463
71064715|NCT00427648|141638365|SUPERIORITY|||||||0.588|||||||Kruskal-Wallis|||null hypothesis - no difference in average number of voids between the 2 groups, power calculation estimated 40 participants needed per arm to show a 2 void difference between lidocaine and saline placebo.||||0.588
71064716|NCT00427648|141638366|SUPERIORITY|||||||0.617|||||||Kruskal-Wallis|||||||0.617
70852654|NCT01578850|141194325|SUPERIORITY_OR_OTHER||Difference in proportions|31.3|||<|0.001|TWO_SIDED|95.0|21.51|41.08|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 44||41.08|21.51|<0.001
70937898|NCT05066230|141375619|SUPERIORITY||Difference of weighted percentages|39.7|||<|0.0001|TWO_SIDED|95.02|31.3|48.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by baseline DRSS level (≤level 47 vs. ≥level 53) and HbA1c level (≤8.5% vs. \>8.5%).|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||48.1|31.3|<0.0001
70937899|NCT05066230|141375620|SUPERIORITY||Difference of weighted percentages|-18.7|||<|0.0001|TWO_SIDED|95.02|-26.2|-11.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by baseline DRSS level (≤level 47 vs. ≥level 53) and HbA1c level (≤8.5% vs. \>8.5%).|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||-11.2|-26.2|<0.0001
70941762|NCT04748445|141383935|OTHER||Slope|2.703|STANDARD_ERROR_OF_MEAN|4.094||0.5103|TWO_SIDED|90.0|-4.081|9.487|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 12 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||9.487|-4.081|0.5103
71064717|NCT00427648|141638367|SUPERIORITY|||||||0.441|||||||Kruskal-Wallis|||||||0.441
70852655|NCT01578850|141194325|SUPERIORITY_OR_OTHER||Difference in proportions|30.2|||<|0.001|TWO_SIDED|95.0|19.95|40.47|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 44||40.47|19.95|<0.001
71064718|NCT00427648|141638368|SUPERIORITY|||||||0.189|||||||Kruskal-Wallis|||||||0.189
71064719|NCT00427648|141638369|SUPERIORITY|||||||0.342|||||||Kruskal-Wallis|||||||0.342
71064720|NCT00427648|141638370|SUPERIORITY|||||||0.802|||||||Kruskal-Wallis|||||||0.802
71064721|NCT00427648|141638371|SUPERIORITY|||||||0.366|||||||Kruskal-Wallis|||||||0.366
71064722|NCT00789373|141638414|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||6e-05|TWO_SIDED|95.0|0.49|0.79|||Log Rank|||900 patients were planned to be enrolled in order to randomize 558 pts to maintenance therapy. This trial was powered for the primary endpoint, PFS (90% power, assuming 238 events with 52% censoring and a PFS Hazard Ratio (HR)=0.65, alpha=0.05). This trial was also powered for a secondary endpoint, OS (93% power, assuming 390 events with 30% censoring and an OS HR=0.70). Alpha was controlled for both a preliminary analysis (alpha=0.0001) and final analysis of OS (alpha=0.0499).||0.79|0.49|0.00006
71064723|NCT00789373|141638415|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.0002|TWO_SIDED|95.0|0.51|0.81|||Log Rank|||||0.81|0.51|0.0002
71064724|NCT00789373|141638416|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0195|TWO_SIDED|95.0|0.64|0.96||The predefined alpha for the final analysis of OS is 0.0498 for the unadjusted log-rank test.|Log Rank||Unadjusted HR from Cox model with treatment as the only cofactor.|Type 1 (alpha) error was controlled for the analyses of both PFS and OS in order to maintain an overall two-sided alpha level of 0.05 using a statistical gatekeeping and alpha spending scheme. The unconditional statistical power of the final OS analysis was 93%.||0.96|0.64|0.0195
71064725|NCT03321968|141638424|SUPERIORITY||Adjusted GMT Ratio|1.01|||||TWO_SIDED|95.0|0.87|1.18|||||Adjusted GMT/GMT Ratio based on analysis of covariance (ANCOVA) model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|A/H1N1 (California)||1.18|0.87|
71064726|NCT03321968|141638424|SUPERIORITY||Adjusted GMT Ratio|0.96|||||TWO_SIDED|95.0|0.82|1.12|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|A/H1N1 (California)||1.12|0.82|
71064727|NCT03321968|141638424|SUPERIORITY||Adjusted GMT Ratio|0.94|||||TWO_SIDED|95.0|0.81|1.1|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|A/H1N1 (California)||1.10|0.81|
71064728|NCT03321968|141638424|SUPERIORITY||Adjusted GMT Ratio|0.94|||||TWO_SIDED|95.0|0.77|1.13|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|A/H3N2 (Hong Kong)||1.13|0.77|
71064729|NCT03321968|141638424|SUPERIORITY||Adjusted GMT Ratio|1.09|||||TWO_SIDED|95.0|0.91|1.32|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|A/H3N2 (Hong Kong)||1.32|0.91|
71064730|NCT03321968|141638424|SUPERIORITY||Adjusted GMT Ratio|1.17|||||TWO_SIDED|95.0|0.97|1.41|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|A/H3N2 (Hong Kong)||1.41|0.97|
70937900|NCT05066230|141375621|SUPERIORITY||Difference of weighted percentages|5.6||||0.0058|TWO_SIDED|95.02|1.6|9.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by baseline DRSS level (≤level 47 vs. ≥level 53), HbA1c level (≤8.5% vs. \>8.5%).|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||9.5|1.6|0.0058
70937901|NCT05066230|141375622|SUPERIORITY||Difference of weighted percentages|-6.5||||0.0149|TWO_SIDED|95.02|-11.8|-1.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by baseline DRSS level (≤level 47 vs. ≥level 53) and HbA1c level (≤8.5% vs. \>8.5%).|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||-1.3|-11.8|0.0149
70937902|NCT02164578|141375634|SUPERIORITY|||||||0.004|||||||ANCOVA|ANCOVA for repeated measurements with baseline as covariate||The hypothesis H0 is tested against the one-sided alternative hypothesis H1 H0: µ∆FBF,Riva, week 20 ≤ µ∆FBF, ASA, week 20 versus H1: µΔFBF, Riva, week 20 \> µΔFBF, ASA, week 20 by test procedures for continuous data.||||0.004
71064731|NCT03321968|141638424|SUPERIORITY||Adjusted GMT Ratio|1.0|||||TWO_SIDED|95.0|0.87|1.15|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|B/Brisbane||1.15|0.87|
71064732|NCT03321968|141638424|SUPERIORITY||Adjusted GMT Ratio|1.09|||||TWO_SIDED|95.0|0.95|1.26|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|B/Brisbane||1.26|0.95|
71064733|NCT03321968|141638424|SUPERIORITY||Adjusted GMT Ratio|1.1|||||TWO_SIDED|95.0|0.95|1.26|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|B/Brisbane||1.26|0.95|
71064734|NCT03321968|141638424|SUPERIORITY||Adjusted GMT Ratio|0.93|||||TWO_SIDED|95.0|0.8|1.09|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|B/Phuket||1.09|0.80|
71064735|NCT03321968|141638424|SUPERIORITY||Adjusted GMT Ratio|0.91|||||TWO_SIDED|95.0|0.78|1.07|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|B/Phuket||1.07|0.78|
71111228|NCT02148263|141728957|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||.96
70937903|NCT02164578|141375635|OTHER|||||||0.07|||||||ANCOVA|||||||0.070
70937904|NCT02164578|141375636|OTHER|||||||0.045|||||||ANCOVA|ANCOVA for repeated measurements with baseline as covariate||||||0.045
70937905|NCT02164578|141375637|OTHER|||||||0.125|||||||ANCOVA|||||||0.125
71064736|NCT03321968|141638424|SUPERIORITY||Adjusted GMT Ratio|0.98|||||TWO_SIDED|95.0|0.84|1.15|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|B/Phuket||1.15|0.84|
70937906|NCT02164578|141375638|OTHER|||||||0.217|||||||Wilcoxon (Mann-Whitney)|||||||0.217
70937907|NCT02164578|141375639|OTHER|||||||0.589|||||||Wilcoxon (Mann-Whitney)|||||||0.589
70937908|NCT02507297|141375644|SUPERIORITY|||||||0.367|||||||t-test, 2 sided|||Baseline to 8 weeks after baseline||||.367
70937909|NCT02507297|141375644|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||Baseline to 12 weeks postpartum||||.48
70937910|NCT02507297|141375645|SUPERIORITY|||||||0.136|||||||t-test, 2 sided|||Baseline to 8 weeks after baseline||||.136
70937911|NCT02507297|141375645|SUPERIORITY|||||||0.324|||||||t-test, 2 sided|||Baseline to 12 weeks postpartum||||.324
71064737|NCT04830969|141638439|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.16
71064738|NCT04830969|141638440|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.08
71064739|NCT04830969|141638441|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||0.14
71064740|NCT04830969|141638441|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.8
71064741|NCT04830969|141638442|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||<0.01
71064742|NCT04830969|141638442|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.09
71064743|NCT04830969|141638443|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||< 0.01
71064744|NCT04830969|141638443|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.03
71064745|NCT04830969|141638444|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||< 0.01
71064746|NCT04830969|141638444|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.09
71064747|NCT04830969|141638445|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||Baseline to 3 months||||0.01
71064748|NCT04830969|141638445|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||0.86
71111229|NCT02148263|141728958|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||.14
71111230|NCT02148263|141728959|SUPERIORITY|This is for the upper eyelid evaluation.||||||0.27|||||||Fisher Exact|||||||.27
71111231|NCT02148263|141728959|SUPERIORITY|||||||0.58|||||||Fisher Exact|||This is for the lower eyelid evaluation.||||.58
71111232|NCT02148263|141728960|SUPERIORITY|||||||0.5|||||||Fisher Exact|||Extent||||.50
71064749|NCT04830969|141638445|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||Baseline to 6 months||||0.047
71064750|NCT04830969|141638445|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.75
71064751|NCT04830969|141638446|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||Baseline to 3 months||||0.44
71064752|NCT04830969|141638446|SUPERIORITY|||||||0.22|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||0.22
70937912|NCT02507297|141375646|SUPERIORITY|||||||0.916|||||||t-test, 2 sided|||Baseline to 8 weeks after baseline||||.916
71111233|NCT02148263|141728960|SUPERIORITY|||||||0.76|||||||Fisher Exact|||Type||||.76
70937913|NCT02507297|141375646|SUPERIORITY|||||||0.752|||||||t-test, 2 sided|||Baseline to 12 weeks postpartum||||.752
70937914|NCT02507297|141375647|SUPERIORITY|||||||0.568|||||||t-test, 2 sided|||Baseline to 8 weeks after baseline||||.568
70937915|NCT02507297|141375647|SUPERIORITY|||||||0.568|||||||t-test, 2 sided|||Baseline to 12 weeks postpartum||||.568
71064753|NCT04830969|141638446|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||Baseline to 6 months||||0.29
71064754|NCT04830969|141638446|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.15
71064755|NCT04830969|141638447|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||Baseline to 3 months||||<0.01
70937916|NCT02507297|141375648|SUPERIORITY|||||||0.486|||||||t-test, 2 sided|||||||.486
71064756|NCT04830969|141638447|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||0.31
71111234|NCT02148263|141728960|SUPERIORITY|||||||0.5|||||||Fisher Exact|||Depth||||.50
71111235|NCT02148263|141728961|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
70852656|NCT01578850|141194325|SUPERIORITY_OR_OTHER||Difference in proportions|26.3|||<|0.001|TWO_SIDED|95.0|16.78|35.81|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 52||35.81|16.78|<0.001
70937917|NCT03740737|141375688|OTHER||Treatment difference|63.0|||<|0.001|TWO_SIDED|95.0|55.5|67.1|||Fisher Exact||95% exact Agresti-Min confidence intervals.|||67.1|55.5|<0.001
70937918|NCT03740737|141375689|OTHER||Treatment difference|29.5|||<|0.001|TWO_SIDED|95.0|22.5|33.7|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Ongoing Pregnancy Rate in the Fresh Cycle||33.7|22.5|<0.001
70937919|NCT03740737|141375693|OTHER||Treatment difference|31.8|||<|0.001|TWO_SIDED|95.0|24.7|36.0|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Clinical pregnancy rate in the fresh cycle||36.0|24.7|<0.001
70937920|NCT03740737|141375693|OTHER||Treatment difference|68.2|||<|0.001|TWO_SIDED|95.0|61.2|72.1|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Clinical pregnancy rate cumulatively||72.1|61.2|<0.001
70937921|NCT03740737|141375694|OTHER||Treatment difference|30.5|||<|0.001|TWO_SIDED|95.0|23.4|34.6|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Vital pregnancy rate in the fresh cycle||34.6|23.4|<0.001
70937922|NCT03740737|141375694|OTHER||Treatment difference|65.1|||<|0.001|TWO_SIDED|95.0|57.5|69.1|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Vital pregnancy rate cumulatively||69.1|57.5|<0.001
70937923|NCT03740737|141375696|OTHER||Treatment difference|35.0|||<|0.001|TWO_SIDED|95.0|28.1|39.2|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Positive βhCG rate in the fresh cycle||39.2|28.1|<0.001
71064757|NCT04830969|141638447|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||Baseline to 6 months||||0.08
71064758|NCT04830969|141638447|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.54
71064759|NCT04830969|141638448|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||Baseline to 3 months||||0.01
71064760|NCT04830969|141638448|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||0.04
71064761|NCT04830969|141638448|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Baseline to 6 months||||0.03
71064762|NCT04830969|141638448|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.38
71064763|NCT04830969|141638449|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Baseline to 3 months||||0.02
71064764|NCT04830969|141638449|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||0.18
71064765|NCT04830969|141638449|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||Baseline to 6 months||||0.08
71064766|NCT04830969|141638449|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.41
71064767|NCT04830969|141638450|SUPERIORITY|||||||0.27|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.27
71064768|NCT04830969|141638451|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.54
71064769|NCT04830969|141638452|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.12
71064770|NCT04830969|141638453|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.20
71064771|NCT04830969|141638453|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.07
71064772|NCT04830969|141638454|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
71064773|NCT04830969|141638454|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.64
71064774|NCT04830969|141638455|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
71064775|NCT04830969|141638455|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.11
71111236|NCT02148263|141728962|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
71111237|NCT00132301|141728964|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.4|TWO_SIDED|95.0|0.58|1.11||Log rank test stratified by site.|Log Rank|||||1.11|0.58|0.40
71111238|NCT02012218|141728965|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values were calculated according to testing a null hypothesis of zero mean change.|Mixed Models Analysis|This analysis was conducted using a mixed model repeated measures analysis on observed case data.||The null hypothesis of zero in mean change from baseline in MADRS total score at Week 6 was tested for each treatment group at significance level of 0.05 (2-sided).||||<0.0001
70937924|NCT03740737|141375696|OTHER||Treatment difference|72.4|||<|0.001|TWO_SIDED|95.0|65.3|76.2|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Positive βhCG rate cumulatively||76.2|65.3|<0.001
71064776|NCT04830969|141638456|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||at baseline||||0.7
71064777|NCT04830969|141638456|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||6 months||||0.29
71064778|NCT04830969|141638457|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||||||0.53
71064779|NCT01537042|141638494|SUPERIORITY_OR_OTHER||Treatment Ratio|0.44||||0.0232|TWO_SIDED|95.0|0.22|0.88|||ANCOVA|An analysis of covariance (ANCOVA) was performed for the log-transformed PLMI ratio with treatment and region as factors and Baseline as a covariate.||||0.88|0.22|0.0232
70937925|NCT03740737|141375708|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
71064780|NCT01779440|141638518|SUPERIORITY|||||||0.65||||||The P-Value of 0.65 was calculated from the difference between groups for the above outcome variable.|Chi-squared|||||||0.65
71064781|NCT01408303|141638531|SUPERIORITY_OR_OTHER||LS mean difference relative to olive oil|-2.95|||<|0.05|||||||ANCOVA|p-value from ANCOVA with factors for treatment, statin use and potency, and baseline value as a covariate, and adjusted using Hommel's procedure.||||||<0.05
71064782|NCT01408303|141638531|SUPERIORITY_OR_OTHER||LS mean difference relative to olive oil|-6.0|||<|0.0001|||||||ANCOVA|p-value from ANCOVA with factors for treatment, statin use and potency, and baseline value as a covariate, and adjusted using Hommel's procedure.||||||<0.0001
71064783|NCT01367886|141638567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.53|STANDARD_DEVIATION|4.88||0.19|||||||t-test, 2 sided|||||||0.19
71111239|NCT02720523|141728980|SUPERIORITY||Response Rate Difference|32.7|||<|0.001|TWO_SIDED|95.0|14.3|51.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||51.0|14.3|<0.001
70852657|NCT01578850|141194325|SUPERIORITY_OR_OTHER||Difference in proportions|27.1|||<|0.001|TWO_SIDED|95.0|16.67|37.47|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 52||37.47|16.67|<0.001
70937926|NCT03740737|141375709|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
71064784|NCT01367886|141638568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|STANDARD_DEVIATION|0.87||0.0021|||||||t-test, 2 sided|||||||0.0021
70937927|NCT03740737|141375710|OTHER|||||||0.22|||||||Fisher Exact|||||||0.220
71111240|NCT02720523|141728980|SUPERIORITY||Response Rate Difference|40.8|||<|0.001|TWO_SIDED|95.0|23.5|58.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||58.1|23.5|<0.001
71111241|NCT02720523|141728980|SUPERIORITY||Response Rate Difference|37.1|||<|0.001|TWO_SIDED|95.0|19.4|54.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||54.9|19.4|<0.001
70937928|NCT03740737|141375711|OTHER|||||||0.588|||||||Fisher Exact|||||||0.588
70937929|NCT01286311|141375758|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.99|TWO_SIDED|95.0|0.54|1.86|||Generalized Logistic Regression|||||1.86|0.54|0.99
70937930|NCT01286311|141375759|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.27|TWO_SIDED|95.0|0.84|1.85|||Generalized Logistic Regression|||||1.85|0.84|0.27
70937931|NCT01286311|141375760|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13||||0.038|TWO_SIDED|95.0|1.05|4.32|||Generalized Logistic Regression|||||4.32|1.05|0.038
70937932|NCT01286311|141375761|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.72||||0.13|TWO_SIDED|95.0|0.73|10.1|||Generalized Logistic Regression|||||10.1|0.73|0.13
70937933|NCT01286311|141375762|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.18||||0.3|TWO_SIDED|95.0|0.5|9.5|||Generalized Logistic Regression|||||9.5|0.50|0.30
70941763|NCT04748445|141383935|OTHER||Slope|-0.000202|STANDARD_ERROR_OF_MEAN|5.334||0.7056|TWO_SIDED|90.0|-0.001086|0.0006819|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0006819|-0.001086|0.7056
71064785|NCT01367886|141638569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34|STANDARD_DEVIATION|1.02||0.18|||||||t-test, 2 sided|||||||0.18
71064786|NCT01367886|141638570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.38|STANDARD_DEVIATION|1.34||0.0025|||||||t-test, 2 sided|||||||0.0025
71064787|NCT01938092|141638571|SUPERIORITY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||||||0.62
71064788|NCT01938092|141638572|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||0.66
71064789|NCT01938092|141638573|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
71064790|NCT00985504|141638574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.612|TWO_SIDED|95.0|-1.87|1.1|||Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||1.10|-1.87|0.612
71064791|NCT00985504|141638575|SUPERIORITY_OR_OTHER|||||||0.504||95.0||||This is the p-value for Cognition Items Total Score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.504
71064792|NCT00985504|141638575|SUPERIORITY_OR_OTHER|||||||0.665||95.0||||This is the p-value for the Behavior Items Total Score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.665
71064793|NCT00985504|141638575|SUPERIORITY_OR_OTHER|||||||0.489||95.0||||This is the p-value for Emotional Items Total Score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.489
71064794|NCT00985504|141638575|SUPERIORITY_OR_OTHER|||||||0.945||95.0||||This is the p-value for Other Items Total Score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.945
71064795|NCT00985504|141638576|SUPERIORITY_OR_OTHER|||||||0.157||95.0||||This is the p-value for the Total Score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.157
71064796|NCT00985504|141638576|SUPERIORITY_OR_OTHER|||||||0.119||95.0||||This is the p-value for the Energy Level score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.119
71064797|NCT00985504|141638576|SUPERIORITY_OR_OTHER|||||||0.184||95.0||||This is the p-value for the Motivation and Interest score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.184
71111242|NCT02720523|141728980|OTHER|Cochran-Armitage test was conducted for demonstrating a dose response relationship.|||||<|0.001|||||||Cochran-Armitage test|||||||<0.001
70937934|NCT03034863|141375763|SUPERIORITY||Slope|-0.37|STANDARD_ERROR_OF_MEAN|0.17||0.03|TWO_SIDED|||||All p-values are two-tailed|Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.03
70937935|NCT03034863|141375764|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.69|TWO_SIDED||||||Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.69
71064798|NCT00985504|141638576|SUPERIORITY_OR_OTHER|||||||0.226||95.0||||This is the p-value for the Cognitive Functioning score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.226
71064799|NCT00985504|141638576|SUPERIORITY_OR_OTHER|||||||0.059||95.0||||This is the p-value for the Weight Gain score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.059
71064800|NCT00985504|141638576|SUPERIORITY_OR_OTHER|||||||0.466||95.0||||This is the p-value for the Sleep score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.466
71064801|NCT00985504|141638576|SUPERIORITY_OR_OTHER|||||||0.822||95.0||||This is the p-value for the Sexual Functioning score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.822
71064802|NCT00985504|141638576|SUPERIORITY_OR_OTHER|||||||0.599||95.0||||This is the p-value for the Affect score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.599
71064803|NCT00985504|141638577|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||This is the p-value for the PGI-I.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.723
71064804|NCT00985504|141638578|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.410
71064805|NCT00985504|141638579|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||This is the p-value for the Total Score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.880
71064806|NCT00985504|141638579|SUPERIORITY_OR_OTHER|||||||0.224||95.0||||This is the p-value for the Item 8 (Inability to Feel) score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.224
71064807|NCT00985504|141638580|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED|95.0||||This is the p-value for the Total Score.|ANCOVA|ANCOVA main effect F test||||||0.910
71064808|NCT00985504|141638580|SUPERIORITY_OR_OTHER|||||||0.882||95.0||||This is the p-value for the Motivation/Interest/Enthusiasm Score.|ANCOVA|ANCOVA main effect F test||||||0.882
71064809|NCT00985504|141638580|SUPERIORITY_OR_OTHER|||||||0.657||95.0||||This is the p-value for the Wakefulness/Alertness Score.|ANCOVA|ANCOVA main effect F test||||||0.657
71064810|NCT00985504|141638580|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||This is the p-value for the Energy Score.|ANCOVA|ANCOVA main effect F test||||||0.457
71111243|NCT02720523|141728981|SUPERIORITY||Least Squares (LS) Mean Difference|-1.29|||<|0.001|TWO_SIDED|95.0|-1.693|-0.88|||ANCOVA|ANCOVA model including treatment as the fixed factor, and baseline value and the stratification factor prior bDMARD use as covariates.|Difference = Upadacitinib - Placebo|||-0.880|-1.693|<0.001
70937936|NCT03034863|141375765|SUPERIORITY|||||||0.49||||||All p-values are two-tailed|Fisher Exact|Compares veterans who reported 1+ attempts at any follow-up wave out of total number of veterans in each group (i.e., 0/19 for SAFER; 2/20 for I-SPI).||||||.49
71064811|NCT00985504|141638580|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||This is the p-value for the Ability to Focus/Sustain Attention Score.|ANCOVA|ANCOVA main effect F test||||||0.737
71064812|NCT00985504|141638580|SUPERIORITY_OR_OTHER|||||||0.404||95.0||||This is the p-value for the Ability to Remember/Recall Information Score.|ANCOVA|ANCOVA main effect F test||||||0.404
71064813|NCT00985504|141638580|SUPERIORITY_OR_OTHER|||||||0.808||95.0||||This is the p-value for the Ability to Find Words Score.|ANCOVA|ANCOVA main effect F test||||||0.808
71064814|NCT00985504|141638580|SUPERIORITY_OR_OTHER|||||||0.431||95.0||||This is the p-value for the Sharpness/Mental Acuity Score.|ANCOVA|ANCOVA main effect F test||||||0.431
71064815|NCT00985504|141638581|SUPERIORITY_OR_OTHER|||||||0.821||95.0||||This is the p-value for the SDS Total Score.|ANCOVA|ANCOVA main effect F test||||||0.821
71064816|NCT00985504|141638581|SUPERIORITY_OR_OTHER|||||||0.491||95.0||||This is the p-value for the Item 1 (Work) Score.|ANCOVA|ANCOVA main effect F test||||||0.491
71064817|NCT00985504|141638581|SUPERIORITY_OR_OTHER|||||||0.451||95.0||||This is the p-value for the Item 2 (Family) Score.|ANCOVA|ANCOVA main effect F test||||||0.451
71064818|NCT00985504|141638581|SUPERIORITY_OR_OTHER|||||||0.443||95.0||||This is the p-value for the Item 3 (Social) Score.|ANCOVA|ANCOVA main effect F test||||||0.443
71064819|NCT00985504|141638581|SUPERIORITY_OR_OTHER|||||||0.719||95.0||||This is the p-value for the Item 4 (Days Lost) Score.|ANCOVA|ANCOVA main effect F test||||||0.719
71064820|NCT00985504|141638581|SUPERIORITY_OR_OTHER|||||||0.517||95.0||||This is the p-value for the Item 5 (Days Underproductive) Score.|ANCOVA|ANCOVA main effect F test||||||0.517
71064821|NCT00985504|141638582|SUPERIORITY_OR_OTHER|||||||0.776||95.0|||||Fisher Exact|||||||0.776
71064822|NCT00985504|141638583|SUPERIORITY_OR_OTHER|||||||0.691||95.0|||||Log Rank|||The log-rank test was conducted using Kaplan-Meier Product-Limit method.||||0.691
71064823|NCT00985504|141638584|SUPERIORITY_OR_OTHER|||||||0.724||95.0|||||Fisher Exact|||||||0.724
71064824|NCT03711786|141638587|SUPERIORITY||Odds Ratio (OR)|1.2||||0.836|TWO_SIDED|95.0|0.22|6.65|||Regression - GEE, logistic|From Wald z-statistic from generalized estimating equations (GEE) model with bias-corrected standard error|Enhanced arm (index) compared to basic arm (referent). GEE model with bias-corrected standard errors.|||6.65|0.22|0.836
71064825|NCT03711786|141638588|SUPERIORITY||Odds Ratio (OR)|0.86||||0.877|TWO_SIDED|95.0|0.12|6.14|||Regression - GEE, logistic|From Wald z-statistic from GEE model with bias-corrected standard error|Enhanced arm (index) compared to basic arm (referent). GEE model with bias-corrected standard errors.|||6.14|0.12|0.877
71064826|NCT03711786|141638589|SUPERIORITY||Odds Ratio (OR)|18.36||||0.001|TWO_SIDED|95.0|3.23|104.23|||Regression - GEE, logistic|From Wald z-statistic from GEE model with bias-corrected standard error|Enhanced arm (index) compared to basic arm (referent). GEE model with bias-corrected standard errors.|||104.23|3.23|0.001
71111244|NCT02720523|141728981|SUPERIORITY||LS Mean Difference|-1.6|||<|0.001|TWO_SIDED|95.0|-2.005|-1.19|||ANCOVA|ANCOVA model including treatment as the fixed factor, and baseline value and the stratification factor prior bDMARD use as covariates.|Difference = Upadacitinib - Placebo|||-1.190|-2.005|<0.001
71111245|NCT02720523|141728981|SUPERIORITY||LS Mean Difference|-1.62|||<|0.001|TWO_SIDED|95.0|-2.027|-1.216|||ANCOVA|ANCOVA model including treatment as the fixed factor, and baseline value and the stratification factor prior bDMARD use as covariates.|Difference = Upadacitinib - Placebo|||-1.216|-2.027|<0.001
71111246|NCT02720523|141728982|SUPERIORITY||LS Mean Difference|-0.3|||<|0.001|TWO_SIDED|95.0|-0.465|-0.144|||ANCOVA|ANCOVA model includes treatment as the fixed factor, and the baseline value and stratification factor prior bDMARD use as the covariates.|Difference = Upadacitinib - Placebo|||-0.144|-0.465|<0.001
71111247|NCT02720523|141728982|SUPERIORITY||LS Mean Difference|-0.34|||<|0.001|TWO_SIDED|95.0|-0.505|-0.184|||ANCOVA|ANCOVA model includes treatment as the fixed factor, and the baseline value and stratification factor prior bDMARD use as the covariates.|Difference = Upadacitinib - Placebo|||-0.184|-0.505|<0.001
71064827|NCT03711786|141638590|SUPERIORITY||Odds Ratio (OR)|2.15||||0.017|TWO_SIDED|95.0|1.15|4.01|||Regression - GEE, logistic|From Wald z-statistic from GEE model with bias-corrected standard error|Enhanced arm (index) compared to basic arm (referent). GEE model with bias-corrected standard errors.|||4.01|1.15|0.017
71064828|NCT03711786|141638591|SUPERIORITY||Odds Ratio (OR)|0.9||||0.759|TWO_SIDED|95.0|0.45|1.8|||Regression - GEE, logistic|From Wald z-statistic from GEE model with bias-corrected standard error|Enhanced arm (index) compared to basic arm (referent). GEE model with bias-corrected standard errors.|||1.80|0.45|0.759
71064829|NCT04031846|141638597|OTHER|Difference in % and 95 % confidence interval (CI) are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|0.6|||=|0.824|TWO_SIDED|95.0|-5.0|6.3|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in % : Injection site erythema||6.3|-5.0|= 0.824
71064830|NCT04031846|141638597|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|2.8|||=|0.324|TWO_SIDED|95.0|-2.8|8.4|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Injection site induration||8.4|-2.8|= 0.324
71064831|NCT04031846|141638597|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|11.3|||<|0.001|TWO_SIDED|95.0|5.8|16.6|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Injection site pain||16.6|5.8|< 0.001
71064832|NCT04031846|141638597|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|4.1|||=|0.128|TWO_SIDED|95.0|-1.2|9.4|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Injection site swelling||9.4|-1.2|= 0.128
71111248|NCT02720523|141728982|SUPERIORITY||LS Mean Difference|-0.39|||<|0.001|TWO_SIDED|95.0|-0.55|-0.229|||ANCOVA|ANCOVA model includes treatment as the fixed factor, and the baseline value and stratification factor prior bDMARD use as the covariates.|Difference = Upadacitinib - Placebo|||-0.229|-0.550|<0.001
71111249|NCT02720523|141728983|SUPERIORITY||Response Rate Difference|24.5||||0.007|TWO_SIDED|95.0|7.3|41.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||41.7|7.3|0.007
71111250|NCT02720523|141728983|SUPERIORITY||Response Rate Difference|49.0|||<|0.001|TWO_SIDED|95.0|32.1|65.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||65.9|32.1|<0.001
71111251|NCT02720523|141728983|SUPERIORITY||Response Rate Difference|41.7|||<|0.001|TWO_SIDED|95.0|24.5|58.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||58.8|24.5|<0.001
71111252|NCT02720523|141728984|SUPERIORITY||Response Rate Difference|18.4||||0.004|TWO_SIDED|95.0|6.4|30.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||30.3|6.4|0.004
71111253|NCT02720523|141728984|SUPERIORITY||Response Rate Difference|32.7|||<|0.001|TWO_SIDED|95.0|18.7|46.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||46.6|18.7|<0.001
70852658|NCT01578850|141194327|SUPERIORITY_OR_OTHER||Difference in proportions|1.3||||0.774|TWO_SIDED|95.0|-9.03|11.68|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 24||11.68|-9.03|0.774
70937937|NCT03034863|141375766|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.04||0.03|TWO_SIDED||||||Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.03
70852659|NCT01578850|141194327|SUPERIORITY_OR_OTHER||Difference in proportions|12.3||||0.034|TWO_SIDED|95.0|2.86|21.69|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 28||21.69|2.86|0.034
71064833|NCT04031846|141638598|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|0.4|||=|0.885|TWO_SIDED|95.0|-5.0|5.8|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Decreased appetite||5.8|-5.0|= 0.885
71064834|NCT04031846|141638598|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|5.4|||=|0.045|TWO_SIDED|95.0|0.1|10.7|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Irritability||10.7|0.1|= 0.045
71064835|NCT04031846|141638598|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|4.4|||=|0.131|TWO_SIDED|95.0|-1.3|10.0|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Somnolence||10.0|-1.3|= 0.131
71111254|NCT02720523|141728984|SUPERIORITY||Response Rate Difference|26.0|||<|0.001|TWO_SIDED|95.0|12.9|39.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||39.0|12.9|<0.001
71064836|NCT04031846|141638598|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|-0.1|||=|0.898|TWO_SIDED|95.0|-2.4|2.1|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Urticaria||2.1|-2.4|= 0.898
71064837|NCT04031846|141638599|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|-0.2|||||TWO_SIDED|95.0|-1.0|0.5|||||V114 minus Prevenar 13™|Difference in %||0.5|-1.0|
70937938|NCT03034863|141375767|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.07||0.87|TWO_SIDED||||||Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.87
70937939|NCT03034863|141375768|SUPERIORITY||Slope|0.17|STANDARD_ERROR_OF_MEAN|0.08||0.03|TWO_SIDED||||||Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.03
71064838|NCT04031846|141638600|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.62|||<|0.001|TWO_SIDED|95.0|0.57|0.68||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 1 GMC Ratio: CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.68|0.57|< 0.001
71064839|NCT04031846|141638600|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.28|||<|0.001|TWO_SIDED|95.0|1.17|1.39||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 3 GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.39|1.17|< 0.001
71064840|NCT04031846|141638600|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.75|||<|0.001|TWO_SIDED|95.0|0.68|0.82||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 4 GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.82|0.68|< 0.001
71064841|NCT04031846|141638600|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.64|||<|0.001|TWO_SIDED|95.0|0.59|0.7||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 5 GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.70|0.59|< 0.001
71064842|NCT04031846|141638600|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.68|||<|0.001|TWO_SIDED|95.0|0.61|0.76||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 6A GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.76|0.61|< 0.001
71064843|NCT04031846|141638600|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.95|||<|0.001|TWO_SIDED|95.0|0.85|1.07||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 6B GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.07|0.85|< 0.001
71064844|NCT04031846|141638600|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.72|0.85||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 7F GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.85|0.72|< 0.001
71064845|NCT04031846|141638600|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.72|||<|0.001|TWO_SIDED|95.0|0.66|0.78||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 9V GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.78|0.66|< 0.001
71078451|NCT00410072|141664959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.6||||0.046|TWO_SIDED|95.0|0.2|21.0|||Cochran-Mantel-Haenszel|||||21.0|0.2|0.0460
70852660|NCT01578850|141194327|SUPERIORITY_OR_OTHER||Difference in proportions|16.9||||0.02|TWO_SIDED|95.0|6.33|27.54|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 28||27.54|6.33|0.020
70937940|NCT03034863|141375769|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.08||0.16|TWO_SIDED||||||Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.16
71078452|NCT00410072|141664959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-12.0|9.5|||NC=F|||||9.5|-12.0|
70852661|NCT01578850|141194327|SUPERIORITY_OR_OTHER||Difference in proportions|14.6||||0.007|TWO_SIDED|95.0|5.48|23.8|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 36||23.80|5.48|0.007
70937941|NCT03034863|141375770|SUPERIORITY||Slope|0.09|STANDARD_ERROR_OF_MEAN|0.35||0.81|TWO_SIDED|||||All p-values are two-tailed|Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.81
70937942|NCT03034863|141375771|SUPERIORITY||Slope|-0.37|STANDARD_ERROR_OF_MEAN|0.62||0.55|TWO_SIDED|||||All p-values are two-tailed|Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.55
70937943|NCT03034863|141375772|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.64|TWO_SIDED|||||All p-values are two-tailed|Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.64
70937944|NCT03034863|141375773|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.62|TWO_SIDED|||||All p-values are two-tailed|Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.62
70937945|NCT03034863|141375774|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.03||0.16|TWO_SIDED|||||All p-values are two-tailed|Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.16
71064846|NCT04031846|141638600|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.75|||<|0.001|TWO_SIDED|95.0|0.67|0.83||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 14 GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.83|0.67|< 0.001
71064847|NCT04031846|141638600|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.88|||<|0.001|TWO_SIDED|95.0|0.8|0.95||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 18C GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.95|0.80|< 0.001
71064848|NCT04031846|141638600|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.75|0.91||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 19A GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.91|0.75|< 0.001
71064849|NCT04031846|141638600|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.88|||<|0.001|TWO_SIDED|95.0|0.8|0.97||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 19F GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.97|0.80|< 0.001
71064850|NCT04031846|141638600|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.87|||<|0.001|TWO_SIDED|95.0|0.79|0.97||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 23F GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.97|0.79|< 0.001
71064851|NCT04031846|141638600|SUPERIORITY|Superiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>2.0 (1-sided p-value \<0.025).|GMC Ratio|71.79|||<|0.001|TWO_SIDED|95.0|65.16|79.1||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 22F GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||79.10|65.16|< 0.001
71064852|NCT04031846|141638600|SUPERIORITY|Superiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>2.0 (1-sided p-value \<0.025).|GMC Ratio|46.58|||<|0.001|TWO_SIDED|95.0|42.19|51.42||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 33F GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||51.42|42.19|< 0.001
70937946|NCT03403153|141375847|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<0.01
70852662|NCT01578850|141194327|SUPERIORITY_OR_OTHER||Difference in proportions|24.9|||<|0.001|TWO_SIDED|95.0|14.72|34.98|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 36||34.98|14.72|<0.001
70852663|NCT01578850|141194327|SUPERIORITY_OR_OTHER||Difference in proportions|18.8|||<|0.001|TWO_SIDED|95.0|10.16|27.38|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 44||27.38|10.16|<0.001
70937947|NCT03403153|141375848|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<.01
70937948|NCT03403153|141375849|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<.01
71064853|NCT04031846|141638601|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-2.8|||<|0.001|TWO_SIDED|95.0|-4.7|-1.3||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 1|95% CI is based on the Miettinen \& Nurminen method.|-1.3|-4.7|< 0.001
71064854|NCT04031846|141638601|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|8.2|||<|0.001|TWO_SIDED|95.0|4.4|12.2||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 3|95% CI is based on the Miettinen \& Nurminen method.|12.2|4.4|< 0.001
71064855|NCT04031846|141638601|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-2.2|||<|0.001|TWO_SIDED|95.0|-4.5|-0.1||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 4|95% CI is based on the Miettinen \& Nurminen method.|-0.1|-4.5|< 0.001
71064856|NCT04031846|141638601|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.9|||<|0.001|TWO_SIDED|95.0|-2.2|-0.2||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 5|95% CI is based on the Miettinen \& Nurminen method.|-0.2|-2.2|< 0.001
71064857|NCT04031846|141638601|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-1.9|1.1||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 6A|95% CI is based on the Miettinen \& Nurminen method.|1.1|-1.9|< 0.001
71064858|NCT04031846|141638601|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-1.7|||<|0.001|TWO_SIDED|95.0|-3.5|-0.1||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 6B|95% CI is based on the Miettinen \& Nurminen method.|-0.1|-3.5|< 0.001
71064859|NCT04031846|141638601|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.9|0.9||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 7F|95% CI is based on the Miettinen \& Nurminen method.|0.9|-0.9|< 0.001
71064860|NCT04031846|141638601|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-1.1|||<|0.001|TWO_SIDED|95.0|-2.4|-0.4||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 9V|95% CI is based on the Miettinen \& Nurminen method.|-0.4|-2.4|< 0.001
71064861|NCT04031846|141638601|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.0|0.5||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 14|95% CI is based on the Miettinen \& Nurminen method.|0.5|-1.0|< 0.001
71064862|NCT04031846|141638601|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-1.8|0.9||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 18C|95% CI is based on the Miettinen \& Nurminen method.|0.9|-1.8|< 0.001
71064863|NCT04031846|141638601|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.9|||<|0.001|TWO_SIDED|95.0|-2.2|-0.2||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 19A|95% CI is based on the Miettinen \& Nurminen method.|-0.2|-2.2|< 0.001
71064864|NCT04031846|141638601|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-1.3|0.3||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 19F|95% CI is based on the Miettinen \& Nurminen method.|0.3|-1.3|< 0.001
71064865|NCT04031846|141638601|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.5|||<|0.001|TWO_SIDED|95.0|-2.7|1.5||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 23F|95% CI is based on the Miettinen \& Nurminen method.|1.5|-2.7|< 0.001
71111255|NCT02720523|141728985|SUPERIORITY||LS Mean Difference|4.33|||<|0.001|TWO_SIDED|95.0|2.1|6.57|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||6.57|2.10|<0.001
71111256|NCT02720523|141728985|SUPERIORITY||LS Mean Difference|3.5||||0.002|TWO_SIDED|95.0|1.25|5.75|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||5.75|1.25|0.002
71064866|NCT04031846|141638601|SUPERIORITY|Superiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>10 percentage points (1-sided p-value \<0.025).|Percentage Difference|93.8|||<|0.001|TWO_SIDED|95.0|91.5|95.6||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 22F|95% CI is based on the Miettinen \& Nurminen method.|95.6|91.5|< 0.001
71064867|NCT04031846|141638601|SUPERIORITY|Superiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>10 percentage points (1-sided p-value \<0.025).|Percentage Difference|94.9|||<|0.001|TWO_SIDED|95.0|92.7|96.5||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 33F|95% CI is based on the Miettinen \& Nurminen method.|96.5|92.7|< 0.001
71064868|NCT04031846|141638602|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|-0.6|||<|0.001|TWO_SIDED|95.0|-1.7|0.4||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Diphtheria toxoid|95% CI is based on the Miettinen \& Nurminen method.|0.4|-1.7|< 0.001
70937949|NCT03403153|141375850|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<.01
70937950|NCT03403153|141375851|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<.01
70937951|NCT03403153|141375852|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<.01
71064869|NCT04031846|141638602|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -5% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-1.3|0.3||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Tetanus toxoid|95% CI is based on the Miettinen \& Nurminen method.|0.3|-1.3|< 0.001
71064870|NCT04031846|141638602|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.3|0.9||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Pertussis PT|95% CI is based on the Miettinen \& Nurminen method.|0.9|-1.3|< 0.001
71064871|NCT04031846|141638602|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.0|0.5||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Pertussis FHA|95% CI is based on the Miettinen \& Nurminen method.|0.5|-1.0|< 0.001
71078453|NCT00410072|141664960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|||||TWO_SIDED|95.0|-1.8|16.0|||NC=F|||Analysis at week 48. The stratified analysis was based on HBeAg strata at randomization.||16.0|-1.8|
70937952|NCT03403153|141375853|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<.01
70937953|NCT02791308|141375906|EQUIVALENCE|Proportion of Subjects with Treatment Success at Visit 4/Day 15|Other|0.407|||||TWO_SIDED|90.0|-15.57|3.53||||||Percentage of Subjects with Treatment Success at Visit 4/Day 15||3.53|-15.57|
71078454|NCT00410072|141664960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|||||TWO_SIDED|95.0|-1.1|15.2|||NC=F|||Analysis at week 96. The stratified analysis was based on HBeAg strata at randomization.||15.2|-1.1|
70937954|NCT00674765|141375915|SUPERIORITY_OR_OTHER|||||||0.388|||||||t-test, 2 sided|t=.87||||||.388
70937955|NCT04421456|141375916|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect. For the PANSS-T score, baseline PANSS-P, baseline PANSS-N, and baseline PANSS-G are included in the model as fixed effects for the associated baseline instead of baseline PANSS-T.|Least square mean difference|-1.75|STANDARD_ERROR_OF_MEAN|2.33||0.4528|TWO_SIDED|95.0|-6.35|2.84|||Mixed-effects repeated measures model|||||2.84|-6.35|0.4528
70937956|NCT04421456|141375916|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect. For the PANSS-T score, baseline PANSS-P, baseline PANSS-N, and baseline PANSS-G are included in the model as fixed effects for the associated baseline instead of baseline PANSS-T.|Least square mean difference|-1.96|STANDARD_ERROR_OF_MEAN|2.44||0.4226|TWO_SIDED|95.0|-6.76|2.85|||Mixed-effects repeated measures model|||||2.85|-6.76|0.4226
71078455|NCT00410072|141664961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|-1.5|17.1|||NC=F|||Analysis at Week 48. The stratified analysis was based on HBeAg strata at randomization.||17.1|-1.5|
71078456|NCT00410072|141664961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|||||TWO_SIDED|95.0|-0.2|17.3|||NC=F|||Analysis at Week 96. The stratified analysis was based on HBeAg strata at randomization.||17.3|-0.2|
71078457|NCT00410072|141664963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4|||||TWO_SIDED|95.0|-18.8|-2.0|||NC+F|||Analysis at Week 48. The stratified analysis is based on HBeAg strata at randomization.||-2.0|-18.8|
71078458|NCT00410072|141664963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.8|||||TWO_SIDED|95.0|-21.5|-4.1|||NC=F|||Analysis at Week 96. The stratified analysis is based on HBeAg strata at randomization.||-4.1|-21.5|
71078459|NCT00410072|141664964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.8|||||TWO_SIDED|95.0|-15.9|4.2|||NC=F|||Analysis at Week 48||4.2|-15.9|
71078460|NCT00410072|141664964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2|||||TWO_SIDED|95.0|-20.6|2.3|||NC=F|||Analysis at Week 96||2.3|-20.6|
71078461|NCT00410072|141664965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1|||||TWO_SIDED|95.0|-13.8|5.6|||NC=F|||Analysis at Week 48||5.6|-13.8|
71078462|NCT00410072|141664965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|||||TWO_SIDED|95.0|-21.5|-0.1|||NC=F|||Analysis at Week 96||-0.1|-21.5|
71064872|NCT04031846|141638602|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-1.3|0.3||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Pertussis PRN|95% CI is based on the Miettinen \& Nurminen method.|0.3|-1.3|< 0.001
71064873|NCT04031846|141638602|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.3|2.1||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Hib PRP|95% CI is based on the Miettinen \& Nurminen method.|2.1|-1.3|< 0.001
71064874|NCT04031846|141638602|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|-0.8|||<|0.001|TWO_SIDED|95.0|-2.0|0.0||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: HBsAg|95% CI is based on the Miettinen \& Nurminen method.|-0.0|-2.0|< 0.001
71064875|NCT04031846|141638602|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -5% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|0.7||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Poliovirus 1|95% CI is based on the Miettinen \& Nurminen method.|0.7|-0.7|< 0.001
70937957|NCT04421456|141375917|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.83||0.4479|TWO_SIDED|95.0|-2.25|1.0|||Mixed-effects repeated measures model|||||1.00|-2.25|0.4479
71064876|NCT04031846|141638602|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -5% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|0.7||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Poliovirus 2|95% CI is based on the Miettinen \& Nurminen method.|0.7|-0.7|< 0.001
71064877|NCT04031846|141638602|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -5% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.5|1.1||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Poliovirus 3|95% CI is based on the Miettinen \& Nurminen method.|1.1|-0.5|< 0.001
71078463|NCT00410072|141664966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|||||TWO_SIDED|95.0|-5.3|1.9|||NC=F|||Analysis at Week 48||1.9|-5.3|
71078464|NCT00410072|141664966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|-3.9|6.1|||NC=F|||Analysis at Week 96||6.1|-3.9|
71078465|NCT00410072|141664967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-2.2|2.0|||NC=F|||Analysis at Week 48||2.0|-2.2|
71078466|NCT00410072|141664967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-2.3|4.9|||NC=F|||Analysis at Week 96||4.9|-2.3|
71078467|NCT01421147|141664981|SUPERIORITY_OR_OTHER||LS Mean Difference|0.108||||0.055|TWO_SIDED|95.0|-0.002|0.219|||ANCOVA|||||0.219|-0.002|0.055
71078468|NCT01421147|141664982|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41||||0.205|TWO_SIDED|95.0|-0.23|1.05||P-value is for change at 6 weeks.|ANCOVA|||||1.05|-0.23|0.205
71078469|NCT01421147|141664982|SUPERIORITY_OR_OTHER||LS Mean difference|0.4||||0.32|TWO_SIDED|95.0|-0.4|1.21||P-value is for change at 12 weeks.|ANCOVA|||||1.21|-0.40|0.320
71078470|NCT01421147|141664982|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.373|TWO_SIDED|95.0|-0.46|1.21||P-value is for change at Endpoint, up to 24 weeks.|ANCOVA|||||1.21|-0.46|0.373
71078471|NCT01421147|141664982|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81||||0.131|TWO_SIDED|95.0|-0.25|1.86||P-value is for change at Endpoint, up to 52 weeks.|ANCOVA|||||1.86|-0.25|0.131
71078472|NCT01421147|141664983|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.007||||0.86|TWO_SIDED|95.0|-0.087|0.072||P-value is for change at 6 weeks.|ANCOVA|||||0.072|-0.087|0.860
71078473|NCT01421147|141664983|SUPERIORITY_OR_OTHER||LS Mean Difference|0.113||||0.03|TWO_SIDED|95.0|0.011|0.215||P-value is for change at 12 weeks.|ANCOVA|||||0.215|0.011|0.030
71078474|NCT01421147|141664983|SUPERIORITY_OR_OTHER||LS Mean Difference|0.098||||0.08|TWO_SIDED|95.0|-0.012|0.208||P-value is for change at 24 weeks.|ANCOVA|||||0.208|-0.012|0.080
71078475|NCT01421147|141664983|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.314|TWO_SIDED|95.0|-0.057|0.177||P-value is for change at 36 weeks.|ANCOVA|||||0.177|-0.057|0.314
71078476|NCT01421147|141664983|SUPERIORITY_OR_OTHER||LS Mean Difference|0.004||||0.948|TWO_SIDED|95.0|-0.119|0.127||P-value is for change at 52 weeks.|ANCOVA|||||0.127|-0.119|0.948
71078477|NCT01421147|141664983|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.737|TWO_SIDED|95.0|-0.099|0.14||P-value is for change at Endpoint, up to 52 weeks.|ANCOVA|||||0.140|-0.099|0.737
71078478|NCT01421147|141664984|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.489|TWO_SIDED|95.0|-0.33|0.69||P-value is for Baseline-AM Pre-Meal.|ANCOVA|||||0.69|-0.33|0.489
71078479|NCT01421147|141664984|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48||||0.066|TWO_SIDED|95.0|-1.0|0.03||P-value is for Baseline-AM 2 hrs PP.|ANCOVA|||||0.03|-1.00|0.066
71078480|NCT01421147|141664984|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.28||||0.209|TWO_SIDED|95.0|-0.71|0.16||P-value is for Baseline-MD Pre-Meal.|ANCOVA|||||0.16|-0.71|0.209
71064878|NCT04031846|141638603|NON_INFERIORITY|Non-inferiority of Rotarix™ administered concomitantly with V114 to Rotarix™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMT ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMT Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.8|1.16||1-sided p-value|t-distribution||V114/Prevenar 13™|GMT Ratio: CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group||1.16|0.80|< 0.001
71064879|NCT04031846|141638604|OTHER||GMC Ratio|0.8|||||TWO_SIDED|95.0|0.73|0.88|||||V114 / Prevenar 13™|GMC Ratio Serotype 1: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.88|0.73|
71111257|NCT02720523|141728985|SUPERIORITY||LS Mean Difference|5.93|||<|0.001|TWO_SIDED|95.0|3.64|8.22|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||8.22|3.64|<0.001
71111258|NCT02720523|141728986|SUPERIORITY||Response Rate Difference|34.7|||<|0.001|TWO_SIDED|95.0|17.0|52.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||52.4|17.0|<0.001
71111259|NCT02720523|141728986|SUPERIORITY||Response Rate Difference|51.0|||<|0.001|TWO_SIDED|95.0|34.2|67.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||67.9|34.2|<0.001
71111260|NCT02720523|141728986|SUPERIORITY||Response Rate Difference|53.6|||<|0.001|TWO_SIDED|95.0|37.1|70.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||70.1|37.1|<0.001
71064880|NCT04031846|141638604|OTHER||GMC Ratio|1.85|||||TWO_SIDED|95.0|1.7|2.02|||||V114 / Prevenar 13™|GMC Ratio Serotype 3: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||2.02|1.70|
71064881|NCT04031846|141638604|OTHER||GMC Ratio|1.08|||||TWO_SIDED|95.0|0.98|1.19|||||V114 / Prevenar 13™|GMC Ratio Serotype 4: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.19|0.98|
71064882|NCT04031846|141638604|OTHER||GMC Ratio|0.84|||||TWO_SIDED|95.0|0.74|0.94|||||V114 / Prevenar 13™|GMC Ratio Serotype 5: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.94|0.74|
71111261|NCT02720523|141728987|SUPERIORITY||Response Rate Difference|30.6|||<|0.001|TWO_SIDED|95.0|15.5|45.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||45.7|15.5|<0.001
71111262|NCT02720523|141728987|SUPERIORITY||Response Rate Difference|51.0|||<|0.001|TWO_SIDED|95.0|35.6|66.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||66.4|35.6|<0.001
71111263|NCT02720523|141728987|SUPERIORITY||Response Rate Difference|43.9|||<|0.001|TWO_SIDED|95.0|28.5|59.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||59.3|28.5|<0.001
71111264|NCT02720523|141728988|SUPERIORITY||Response Rate Difference|22.4||||0.006|TWO_SIDED|95.0|7.4|37.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||37.5|7.4|0.006
71111265|NCT02720523|141728988|SUPERIORITY||Response Rate Difference|16.3||||0.026|TWO_SIDED|95.0|2.1|30.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||30.6|2.1|0.026
71064883|NCT04031846|141638604|OTHER||GMC Ratio|0.45|||||TWO_SIDED|95.0|0.4|0.52|||||V114 / Prevenar 13™|GMC Ratio Serotype 6A: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.52|0.40|
71111266|NCT02720523|141728988|SUPERIORITY||Response Rate Difference|25.8||||0.002|TWO_SIDED|95.0|10.6|41.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||41.0|10.6|0.002
71111267|NCT02720523|141728989|SUPERIORITY||LS Mean Difference|2.66||||0.04|TWO_SIDED|95.0|0.12|5.2|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||5.20|0.12|0.040
70937958|NCT04421456|141375917|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|-1.22|STANDARD_ERROR_OF_MEAN|0.87||0.1616|TWO_SIDED|95.0|-2.92|0.49|||Mixed-effects repeated measures model|||||0.49|-2.92|0.1616
70937959|NCT04421456|141375918|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.76||0.6787|TWO_SIDED|95.0|-1.8|1.18|||Mixed-effects repeated measures model|||||1.18|-1.80|0.6787
70937960|NCT04421456|141375918|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|0.76|STANDARD_ERROR_OF_MEAN|0.78||0.3351|TWO_SIDED|95.0|-0.79|2.3|||Mixed-effects repeated measures model|||||2.30|-0.79|0.3351
70937961|NCT04421456|141375919|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.45||0.4504|TWO_SIDED|95.0|-3.96|1.76|||Mixed-effects repeated measures model|||||1.76|-3.96|0.4504
70937962|NCT04421456|141375919|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|-1.23|STANDARD_ERROR_OF_MEAN|1.52||0.4195|TWO_SIDED|95.0|-4.22|1.76|||Mixed-effects repeated measures model|||||1.76|-4.22|0.4195
70937963|NCT04421456|141375920|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm, visit by treatment arm interaction and visit by associated baseline interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.16||0.885|TWO_SIDED|95.0|-0.35|0.3|||Mixed-effects repeated measures model|||||0.30|-0.35|0.8850
70937964|NCT04421456|141375920|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm, visit by treatment arm interaction and visit by associated baseline interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.16||0.7808|TWO_SIDED|95.0|-0.36|0.27|||Mixed-effects repeated measures model|||||0.27|-0.36|0.7808
70937965|NCT04421456|141375921|SUPERIORITY||Odds Ratio (OR)|1.412||||0.6707|TWO_SIDED|95.0|0.288|6.924|||Regression, Logistic|||||6.924|0.288|0.6707
71064884|NCT04031846|141638604|OTHER||GMC Ratio|1.18|||||TWO_SIDED|95.0|1.0|1.41|||||V114 / Prevenar 13™|GMC Ratio Serotype 6B: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.41|1.00|
70937966|NCT04421456|141375921|SUPERIORITY||Odds Ratio (OR)|0.576||||0.4883|TWO_SIDED|95.0|0.121|2.744|||Regression, Logistic|||||2.744|0.121|0.4883
70937967|NCT01694199|141375937|SUPERIORITY_OR_OTHER|||||||0.3529|||||||ANCOVA|||||||0.3529
70937968|NCT01694199|141375938|SUPERIORITY_OR_OTHER|||||||0.2766|||||||ANCOVA|||||||0.2766
70937969|NCT01694199|141375939|SUPERIORITY_OR_OTHER|||||||0.1467|||||||ANOVA|||P=0.1467||||0.1467
70937970|NCT01694199|141375940|SUPERIORITY_OR_OTHER|||||||0.5009|||||||ANOVA|||P = 0.5009||||0.5009
70937971|NCT01694199|141375941|SUPERIORITY_OR_OTHER|||||||0.9038|||||||ANOVA|||||||0.9038
70937972|NCT03031782|141375963|SUPERIORITY||Cox Proportional Hazard|0.28|||<|0.001|TWO_SIDED|95.0|0.13|0.63|||Log Rank|Hazard ratios and associated 95% confidence intervals are based on a Cox proportional hazards model with treatment and analysis factors||Survival analysis of time to flare - TP2 (FAS2)||0.63|0.13|<0.001
70937973|NCT01930188|141375974|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 1.0 mg and sitagliptin was below the pre-specified non-inferiority margin (0.3 %).|treatment difference|-1.06|||<|0.0001|TWO_SIDED|95.0|-1.21|-0.91|||Mixed Models Analysis|Post-baseline responses analysed with mixed model for repeated measurements-treatment \& country (fixed) \& baseline (covariate) all nested within visit||||-0.91|-1.21|<0.0001
70937974|NCT01930188|141375974|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 0.5 mg and sitagliptin was below the pre-specified non-inferiority margin (0.3 %).|treatment difference|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.21|-0.62|||Mixed Models Analysis|Analysis done with mixed model for repeated measurements (treatment \& country as fixed factors \& baseline value as covariate) all nested within visit||||-0.62|-1.21|<0.0001
70937975|NCT00886834|141375989|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||t-test, 2 sided|||||||0.64
70937976|NCT03122860|141375991|SUPERIORITY||Median Difference (Final Values)|-0.46||||0.179|TWO_SIDED|95.0|-1.13|0.21|||ANCOVA|||||0.21|-1.13|0.179
70937977|NCT03122860|141375991|SUPERIORITY||Median Difference (Final Values)|-0.7||||0.031|TWO_SIDED|95.0|-1.34|-0.06|||ANCOVA|||||-0.06|-1.34|0.031
70937978|NCT03122860|141375991|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.675|TWO_SIDED|95.0|-0.81|0.52|||ANCOVA|||||0.52|-0.81|0.675
71064885|NCT04031846|141638604|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.76|0.91|||||V114 / Prevenar 13™|GMC Ratio Serotype 7F: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.91|0.76|
71064886|NCT04031846|141638604|OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.77|0.96|||||V114 / Prevenar 13™|GMC Ratio Serotype 9V: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.96|0.77|
71064887|NCT04031846|141638604|OTHER||GMC Ratio|0.75|||||TWO_SIDED|95.0|0.66|0.86|||||V114 / Prevenar 13™|GMC Ratio Serotype 14: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.86|0.66|
71064888|NCT04031846|141638604|OTHER||GMC Ratio|0.85|||||TWO_SIDED|95.0|0.77|0.95|||||V114 / Prevenar 13™|GMC Ratio Serotype 18C: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.95|0.77|
71064889|NCT04031846|141638604|OTHER||GMC Ratio|0.78|||||TWO_SIDED|95.0|0.7|0.87|||||V114 / Prevenar 13™|GMC Ratio Serotype 19A: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.87|0.70|
71064890|NCT04031846|141638604|OTHER||GMC Ratio|0.77|||||TWO_SIDED|95.0|0.7|0.85|||||V114 / Prevenar 13™|GMC Ratio Serotype 19F: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.85|0.70|
71064891|NCT04031846|141638604|OTHER||GMC Ratio|1.22|||||TWO_SIDED|95.0|1.07|1.4|||||V114 / Prevenar 13™|GMC Ratio Serotype 23F: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.40|1.07|
71064892|NCT04031846|141638604|OTHER||GMC Ratio|57.69|||||TWO_SIDED|95.0|51.2|65.0|||||V114 / Prevenar 13™|GMC Ratio Serotype 22F: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||65.00|51.20|
71064893|NCT04031846|141638604|OTHER||GMC Ratio|6.24|||||TWO_SIDED|95.0|5.46|7.14|||||V114 / Prevenar 13™|GMC Ratio Serotype 33F: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||7.14|5.46|
71064894|NCT04031846|141638605|OTHER||Percentage Difference|-2.0|||||TWO_SIDED|95.0|-4.4|0.3|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 1|95% CI are based on the Miettinen \& Nurminen method.|0.3|-4.4|
71064895|NCT04031846|141638605|OTHER||Percentage Difference|25.7|||||TWO_SIDED|95.0|21.1|30.3|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 3|95% CI are based on the Miettinen \& Nurminen method.|30.3|21.1|
71064896|NCT04031846|141638605|OTHER||Percentage Difference|-2.9|||||TWO_SIDED|95.0|-5.7|-0.3|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 4|95% CI are based on the Miettinen \& Nurminen method.|-0.3|-5.7|
71064897|NCT04031846|141638605|OTHER||Percentage Difference|-3.9|||||TWO_SIDED|95.0|-8.1|0.3|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 5|95% CI are based on the Miettinen \& Nurminen method.|0.3|-8.1|
71111268|NCT02720523|141728989|SUPERIORITY||LS Mean Difference|1.79||||0.169|TWO_SIDED|95.0|-0.77|4.35|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||4.35|-0.77|0.169
70937979|NCT03122860|141375991|SUPERIORITY||Mean Difference (Final Values)|-0.82||||0.022|TWO_SIDED|95.0|-1.51|-0.12|||ANCOVA|||||-0.12|-1.51|0.022
71064898|NCT04031846|141638605|OTHER||Percentage Difference|-19.4|||||TWO_SIDED|95.0|-23.9|-15.0|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 6A|95% CI are based on the Miettinen \& Nurminen method.|-15.0|-23.9|
71064899|NCT04031846|141638605|OTHER||Percentage Difference|4.6|||||TWO_SIDED|95.0|-1.5|10.7|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 6B|95% CI are based on the Miettinen \& Nurminen method.|10.7|-1.5|
71064900|NCT04031846|141638605|OTHER||Percentage Difference|-1.1|||||TWO_SIDED|95.0|-2.9|0.5|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 7F|95% CI are based on the Miettinen \& Nurminen method.|0.5|-2.9|
71064901|NCT04031846|141638605|OTHER||Percentage Difference|-6.7|||||TWO_SIDED|95.0|-10.1|-3.5|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 9V|95% CI are based on the Miettinen \& Nurminen method.|-3.5|-10.1|
71064902|NCT04031846|141638605|OTHER||Percentage Difference|-0.5|||||TWO_SIDED|95.0|-2.6|1.7|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 14|95% CI are based on the Miettinen \& Nurminen method.|1.7|-2.6|
71064903|NCT04031846|141638605|OTHER||Percentage Difference|-0.7|||||TWO_SIDED|95.0|-3.9|2.6|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 18C|95% CI are based on the Miettinen \& Nurminen method.|2.6|-3.9|
71064904|NCT04031846|141638605|OTHER||Percentage Difference|-1.2|||||TWO_SIDED|95.0|-3.5|1.0|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 19A|95% CI are based on the Miettinen \& Nurminen method.|1.0|-3.5|
71064905|NCT04031846|141638605|OTHER||Percentage Difference|-0.5|||||TWO_SIDED|95.0|-2.0|0.7|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 19F|95% CI are based on the Miettinen \& Nurminen method.|0.7|-2.0|
71064906|NCT04031846|141638605|OTHER||Percentage Difference|6.6|||||TWO_SIDED|95.0|1.3|11.9|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 23F|95% CI are based on the Miettinen \& Nurminen method.|11.9|1.3|
71064907|NCT04031846|141638605|OTHER||Percentage Difference|90.4|||||TWO_SIDED|95.0|87.4|92.7|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 22F|95% CI are based on the Miettinen \& Nurminen method.|92.7|87.4|
71064908|NCT04031846|141638605|OTHER||Percentage Difference|45.9|||||TWO_SIDED|95.0|41.3|50.3|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 33F|95% CI are based on the Miettinen \& Nurminen method.|50.3|41.3|
71064909|NCT04031846|141638608|OTHER|Percentage difference and CI are based on the Miettinen \& Nurminen method.|Percentage Difference|15.8|||||TWO_SIDED|95.0|12.9|19.2|||||V114 minus Prevenar 13™|Percentage Difference: V114 Serotype 22F minus Prevenar 13™ Serotype 3||19.2|12.9|
71064910|NCT04031846|141638608|OTHER|Percentage difference and CI are based on the Miettinen \& Nurminen method.|Percentage Difference|15.3|||||TWO_SIDED|95.0|12.2|18.7|||||V114 minus Prevenar 13™|Percentage Difference: V114 Serotype 33F minus Prevenar 13™ Serotype 3||18.7|12.2|
70937980|NCT03122860|141375991|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.78|TWO_SIDED|95.0|-0.79|0.59|||ANCOVA|||||0.59|-0.79|0.780
71064911|NCT06868654|141638609|OTHER||Hazard Ratio (HR)|0.24|||||TWO_SIDED|95.0|0.11|0.56|||||Hazard ratio was estimated using a Cox Proportional Hazards model stratified by the number of lines of prior therapy, prior bortezomib and revised international staging system (R-ISS) at screening, with a covariate of treatment.|||0.56|0.11|
71064912|NCT00764660|141638641|SUPERIORITY_OR_OTHER||Difference in LS Means|2.4||||0.41|TWO_SIDED|95.0|-3.4|8.2|||Repeated Measures Model||Repeated Measures Model with factors for treatment, pooled centers, assessment and assessment by treatment interaction.|||8.2|-3.4|0.41
71064913|NCT00764660|141638642|SUPERIORITY_OR_OTHER||Difference in Least Squares (LS) Means|-1.9||||0.3|TWO_SIDED|95.0|-5.5|1.7|||Repeated Measures Model||Repeated Measures Model with factors for treatment, pooled centers, assessment and assessment by treatment interaction.|||1.7|-5.5|0.30
71064914|NCT00764660|141638643|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.52|TWO_SIDED|95.0|0.57|1.33|||Chi-squared|Zero Inflated Negative Binomial (ZINB) Distribution with terms for treatment and region||||1.33|0.57|0.52
71064915|NCT00764660|141638644|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.81|TWO_SIDED|95.0|0.71|1.31|||Chi-squared|ZINB Distribution with terms for treatment and region||||1.31|0.71|0.81
71064916|NCT00764660|141638645|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||0.26|TWO_SIDED|95.0|0.81|2.12||Model with factors treatment and pooled centers as stratum.|Kaplan-Meier|||||2.12|0.81|0.26
71064917|NCT00764660|141638646|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.1||||0.59|TWO_SIDED|95.0|-9.9|5.7|||Repeated Measures Model|Repeated Measures Model with factors for treatment, pooled centers, assessment and assessment by treatment interaction.||||5.7|-9.9|0.59
71078481|NCT01421147|141664984|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31||||0.232|TWO_SIDED|95.0|-0.2|0.82||P-value is for Baseline-MD 2 hrs PP.|ANCOVA|||||0.82|-0.20|0.232
71078482|NCT01421147|141664984|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05||||0.856|TWO_SIDED|95.0|-0.49|0.58||P-value is for Baseline-EV Pre-Meal.|ANCOVA|||||0.58|-0.49|0.856
70937981|NCT03122860|141375992|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.612|TWO_SIDED|95.0|-8.32|4.91|||ANCOVA|||||4.91|-8.32|0.612
71078483|NCT01421147|141664984|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11||||0.693|TWO_SIDED|95.0|-0.66|0.44||P-value is for Baseline-Bed Time.|ANCOVA|||||0.44|-0.66|0.693
70937982|NCT03122860|141375992|SUPERIORITY||Mean Difference (Final Values)|-4.01||||0.223|TWO_SIDED|95.0|-10.47|2.46|||ANCOVA|||||2.46|-10.47|0.223
70937983|NCT03122860|141375992|SUPERIORITY||Mean Difference (Final Values)|1.84||||0.59|TWO_SIDED|95.0|-4.89|8.57|||ANCOVA|||||8.57|-4.89|0.590
71078484|NCT01421147|141664984|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.7|TWO_SIDED|95.0|-0.61|0.41||P-value is for Baseline-0300 hrs.|ANCOVA|||||0.41|-0.61|0.700
71078485|NCT01421147|141664984|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17||||0.399|TWO_SIDED|95.0|-0.23|0.58||P-value is for Endpoint, up to 24 wk-AM Pre-Meal.|ANCOVA|||||0.58|-0.23|0.399
71078486|NCT01421147|141664984|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.248|TWO_SIDED|95.0|-0.18|0.68||P-value is for Endpoint, up to 24 wk-AM 2 hrs PP.|ANCOVA|||||0.68|-0.18|0.248
71078487|NCT01421147|141664984|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.883|TWO_SIDED|95.0|-0.44|0.38||P-value is for Endpoint, up to 24 wk-MD Pre-Meal.|ANCOVA|||||0.38|-0.44|0.883
71078488|NCT01421147|141664984|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.687|TWO_SIDED|95.0|-0.34|0.52||P-value is for Endpoint, up to 24 wk-MD 2 hrs PP.|ANCOVA|||||0.52|-0.34|0.687
71078489|NCT01421147|141664984|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.364|TWO_SIDED|95.0|-0.24|0.65||P-value is for Endpoint, up to 24 wk-EV Pre-Meal.|ANCOVA|||||0.65|-0.24|0.364
71078490|NCT01421147|141664984|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.03|TWO_SIDED|95.0|-0.95|-0.05||P-value is for Endpoint, up to 24 wk- Bed Time.|ANCOVA|||||-0.05|-0.95|0.030
71078491|NCT01421147|141664984|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.45||||0.033|TWO_SIDED|95.0|-0.86|-0.04||P-value is for Endpoint, up to 24 wk-0300 hrs.|ANCOVA|||||-0.04|-0.86|0.033
71078492|NCT01421147|141664984|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.26||||0.23|TWO_SIDED|95.0|-0.68|0.16||P-value is for Endpoint, up to 52 wk-AM Pre-Meal.|ANCOVA|||||0.16|-0.68|0.230
71078493|NCT01421147|141664984|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32||||0.148|TWO_SIDED|95.0|-0.76|0.11||P-value is for Endpoint, up to 52 wk-AM 2 hrs PP.|ANCOVA|||||0.11|-0.76|0.148
71078494|NCT01421147|141664984|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.866|TWO_SIDED|95.0|-0.43|0.36||P-value is for Endpoint, up to 52 wk-MD Pre-Meal.|ANCOVA|||||0.36|-0.43|0.866
71078495|NCT01421147|141664984|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13||||0.545|TWO_SIDED|95.0|-0.56|0.3||P-value is for Endpoint, up to 52 wk-MD 2 hrs PP.|ANCOVA|||||0.30|-0.56|0.545
71078496|NCT01421147|141664984|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01||||0.955|TWO_SIDED|95.0|-0.44|0.42||P-value is for Endpoint, up to 52 wk-EV Pre-Meal.|ANCOVA|||||0.42|-0.44|0.955
71078497|NCT01421147|141664984|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48||||0.031|TWO_SIDED|95.0|-0.92|-0.04||P-value is for Endpoint, up to 52 wk-Bed Time.|ANCOVA|||||-0.04|-0.92|0.031
71078498|NCT01421147|141664984|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21||||0.355|TWO_SIDED|95.0|-0.65|0.23||P-vale is for Endpoint, up to 52 wk-0300 hrs.|ANCOVA|||||0.23|-0.65|0.355
70937984|NCT03122860|141375992|SUPERIORITY||Mean Difference (Final Values)|-7.36||||0.031|TWO_SIDED|95.0|-14.03|-0.69|||ANCOVA|||||-0.69|-14.03|0.031
71064918|NCT00764660|141638647|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.34|TWO_SIDED|95.0|0.65|3.43|||Regression, Logistic|An Odds Ratio (SCH 900435/Placebo) \>1 means SCH 900435 has a higher probability of achieving complete abstinence.||||3.43|0.65|0.34
71064919|NCT00764660|141638650|SUPERIORITY_OR_OTHER||Difference in LS Means|2.88||||0.54|TWO_SIDED|95.0|-6.3|12.06|||Contrained Longitudinal Data Analysis||Constrained Longitudinal Data Analysis (cLDA) Model with terms for treatment, pooled centers, assessment by treatment interaction.|||12.06|-6.30|0.54
71064920|NCT00764660|141638651|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.1||||0.51|TWO_SIDED|95.0|-12.35|6.15|||cLDA Model||cLDA Model with terms for treatment, pooled centers, assessment by treatment interaction.|||6.15|-12.35|0.51
71111269|NCT02720523|141728989|SUPERIORITY||LS Mean Difference|0.85||||0.516|TWO_SIDED|95.0|-1.73|3.43|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||3.43|-1.73|0.516
71111270|NCT02720523|141728990|SUPERIORITY||LS Mean Difference|-2.54||||0.021|TWO_SIDED|95.0|-4.68|-0.39|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||-0.39|-4.68|0.021
70937985|NCT03122860|141375992|SUPERIORITY||Mean Difference (Final Values)|-2.89||||0.403|TWO_SIDED|95.0|-9.7|3.92|||ANCOVA|||||3.92|-9.70|0.403
70937986|NCT03122860|141375993|SUPERIORITY||Mean Difference (Final Values)|-2.58||||0.432|TWO_SIDED|95.0|-9.04|3.88|||ANCOVA|||||3.88|-9.04|0.432
71064921|NCT00764660|141638652|SUPERIORITY_OR_OTHER||Difference in LS Means|-9.17||||0.05|TWO_SIDED|95.0|-18.27|-0.07|||cLDA Model||cLDA Model with terms for treatment, pooled centers, assessment by treatment interaction.|||-0.07|-18.27|0.05
71064922|NCT01540487|141638665|SUPERIORITY_OR_OTHER||adjusted gMean ratio|99.5|||||TWO_SIDED|90.0|94.7|104.5|||ANOVA|||||104.5|94.7|
71064923|NCT01540487|141638665|SUPERIORITY_OR_OTHER||adjusted gMean ratio|100.8|||||TWO_SIDED|90.0|95.1|106.8|||ANOVA|||||106.8|95.1|
71064924|NCT01540487|141638666|SUPERIORITY_OR_OTHER||adjusted gMean ratio|101.9|||||TWO_SIDED|90.0|95.4|109.0|||ANOVA|||||109.0|95.4|
71111271|NCT02720523|141728990|SUPERIORITY||LS Mean Difference|-2.06||||0.08|TWO_SIDED|95.0|-4.36|0.25|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||0.25|-4.36|0.080
71111272|NCT02720523|141728990|SUPERIORITY||LS Mean Difference|-1.56||||0.22|TWO_SIDED|95.0|-4.06|0.94|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||0.94|-4.06|0.220
71111273|NCT02720523|141728991|SUPERIORITY||LS Mean Difference|-1.81|||<|0.001|TWO_SIDED|95.0|-2.57|-1.04|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||-1.04|-2.57|<0.001
70937987|NCT03122860|141375993|SUPERIORITY||Mean Difference (Final Values)|-4.34||||0.18|TWO_SIDED|95.0|-10.69|2.02|||ANCOVA|||||2.02|-10.69|0.180
71064925|NCT01540487|141638666|SUPERIORITY_OR_OTHER||adjusted gMean ratio|111.4|||||TWO_SIDED|90.0|100.4|123.5|||ANOVA|||||123.5|100.4|
71064926|NCT01540487|141638667|SUPERIORITY_OR_OTHER||adjusted gMean ratio|97.0|||||TWO_SIDED|90.0|90.6|103.8|||ANOVA|||||103.8|90.6|
71064927|NCT01540487|141638667|SUPERIORITY_OR_OTHER||adjusteg gMean ratio|103.0|||||TWO_SIDED|90.0|96.2|110.1|||ANOVA|||||110.1|96.2|
71064928|NCT01540487|141638668|SUPERIORITY_OR_OTHER||adjusted gMean ratio|94.6|||||TWO_SIDED|90.0|85.4|104.8|||ANOVA|||||104.8|85.4|
71064929|NCT01540487|141638668|SUPERIORITY_OR_OTHER||adjusted gMean ratio|102.5|||||TWO_SIDED|90.0|92.2|113.9|||ANOVA|||||113.9|92.2|
71064930|NCT01540487|141638669|SUPERIORITY_OR_OTHER||adjusted gMean ratio|110.1|||||TWO_SIDED|90.0|100.5|120.6|||ANOVA|||||120.6|100.5|
71064931|NCT01540487|141638669|SUPERIORITY_OR_OTHER||adjusted gMean ratio|89.3|||||TWO_SIDED|90.0|80.2|99.3|||ANOVA|||||99.3|80.2|
71064932|NCT01540487|141638670|SUPERIORITY_OR_OTHER||adjusted gMean ratio|98.0|||||TWO_SIDED|90.0|92.0|104.5|||ANOVA|||||104.5|92.0|
71064933|NCT01540487|141638670|SUPERIORITY_OR_OTHER||adjusted gMean ratio|102.8|||||TWO_SIDED|90.0|97.0|109.0|||ANOVA|||||109.0|97.0|
71064934|NCT01540487|141638671|SUPERIORITY_OR_OTHER||adjusted gMean ratio|99.5|||||TWO_SIDED|90.0|94.7|104.6|||ANOVA|||||104.6|94.7|
71064935|NCT01540487|141638671|SUPERIORITY_OR_OTHER||adjusted gMean ratio|100.8|||||TWO_SIDED|90.0|95.1|106.8|||ANOVA|||||106.8|95.1|
71064936|NCT01894841|141638695|SUPERIORITY||Partial eta squared|0.03||||0.13|TWO_SIDED|||||Adjusted for change in depression from baseline to 1yr (measured via QIDS).|RMANOVA|||||||.13
71064937|NCT01894841|141638696|SUPERIORITY||Partial eta squared|0.01||||0.79|TWO_SIDED||||||RMANOVA|Adjusted for change in depression from baseline to 1yr (measured via QIDS).||||||.79
70937988|NCT03122860|141375993|SUPERIORITY||Mean Difference (Final Values)|1.19||||0.718|TWO_SIDED|95.0|-5.33|7.72|||ANCOVA|||||7.72|-5.33|0.718
70937989|NCT03122860|141375993|SUPERIORITY||Mean Difference (Final Values)|-7.99||||0.017|TWO_SIDED|95.0|-14.54|-1.45|||ANCOVA|||||-1.45|-14.54|0.017
70937990|NCT03122860|141375993|SUPERIORITY||Mean Difference (Final Values)|-1.39||||0.682|TWO_SIDED|95.0|-8.06|5.29|||ANCOVA|||||5.29|-8.06|0.682
70937991|NCT03122860|141375994|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.822|TWO_SIDED|95.0|-0.16|0.21|||ANCOVA|||||0.21|-0.16|0.822
70937992|NCT03122860|141375994|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.162|TWO_SIDED|95.0|-0.27|0.04|||ANCOVA|||||0.04|-0.27|0.162
70937993|NCT03122860|141375994|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.267|TWO_SIDED|95.0|-0.34|0.09|||ANCOVA|||||0.09|-0.34|0.267
70937994|NCT03122860|141375994|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.685|TWO_SIDED|95.0|-0.18|0.12|||ANCOVA|||||0.12|-0.18|0.685
71064938|NCT01894841|141638697|SUPERIORITY||Partial eta squared|0.02||||0.49|TWO_SIDED|||||Adjusted for change in depression from baseline to 1yr (measured via QIDS).|RMANOVA|||||||.49
71064939|NCT01894841|141638698|SUPERIORITY||Partial eta-squared|0.003||||0.96|TWO_SIDED|||||Adjusted for change in depression from baseline to 1yr (measured via QIDS).|RMANOVA|||||||.96
71064940|NCT01894841|141638699|SUPERIORITY||Partial eta squared|0.01||||0.62|TWO_SIDED||||||RMANOVA|Adjusted for change in depression from baseline to 1yr (measured via QIDS).||||||.62
71064941|NCT00708552|141638750|SUPERIORITY||Mean Difference (Net)|1.1||||0.159|TWO_SIDED|95.0|-0.4|2.7|||Mixed model repeated measures|||ADAS-Cog Total Score, Placebo Vs SB-742457-15mg at Week 24||2.7|-0.4|0.159
71064942|NCT00708552|141638750|SUPERIORITY||Mean Difference (Net)|0.7||||0.41|TWO_SIDED|95.0|-0.9|2.3|||Mixed model repeated measures|||ADAS-Cog Total Score, Placebo Vs SB-742457-35mg at Week 24||2.3|-0.9|0.410
71064943|NCT00708552|141638750|SUPERIORITY||Mean Difference (Net)|-0.2||||0.821|TWO_SIDED|95.0|-1.6|1.2|||Mixed model repeated measures|||ADAS-Cog Total Score, Placebo Vs Donepezil at Week 24||1.2|-1.6|0.821
71064944|NCT00708552|141638751|SUPERIORITY||Mean Difference (Net)|0.2||||0.254|TWO_SIDED|95.0|-0.1|0.5|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs SB-742457-15mg at Week 24||0.5|-0.1|0.254
71064945|NCT00708552|141638751|SUPERIORITY||Mean Difference (Net)|-0.1||||0.394|TWO_SIDED|95.0|-0.4|0.2|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs SB-742457-35mg at Week 24||0.2|-0.4|0.394
71064946|NCT00708552|141638751|SUPERIORITY||Mean Difference (Net)|-0.3||||0.049|TWO_SIDED|95.0|-0.6|0.0|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs Donepezil at Week 24||-0.0|-0.6|0.049
71064947|NCT00708552|141638752|SUPERIORITY||Mean Difference (Net)|-1.6||||0.423|TWO_SIDED|95.0|-5.6|2.3|||Mixed model repeated measures|||RBANS Total Score, Placebo Vs SB-742457-15mg at Week 24||2.3|-5.6|0.423
71064948|NCT00708552|141638752|SUPERIORITY||Mean Difference (Net)|-2.1||||0.305|TWO_SIDED|95.0|-6.1|1.9|||Mixed model repeated measures|||RBANS Total Score, Placebo Vs SB-742457-35mg at Week 24||1.9|-6.1|0.305
71064949|NCT00708552|141638752|SUPERIORITY||Mean Difference (Net)|2.0||||0.282|TWO_SIDED|95.0|-1.7|5.7|||Mixed model repeated measures|||RBANS Total Score, Placebo Vs Donepezil at Week 24||5.7|-1.7|0.282
71064950|NCT00708552|141638753|SUPERIORITY||Mean Difference (Net)|1.4||||0.096|TWO_SIDED|95.0|-0.3|3.1|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs SB-742457-15mg at Week 24||3.1|-0.3|0.096
71064951|NCT00708552|141638753|SUPERIORITY||Mean Difference (Net)|1.0||||0.281|TWO_SIDED|95.0|-0.8|2.8|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs SB-742457-35mg at Week 24||2.8|-0.8|0.281
71064952|NCT00708552|141638753|SUPERIORITY||Mean Difference (Net)|0.4||||0.63|TWO_SIDED|95.0|-1.1|1.9|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs Donepezil at Week 24||1.9|-1.1|0.630
71064953|NCT00708552|141638753|SUPERIORITY||Mean Difference (Net)|-1.1||||0.655|TWO_SIDED|95.0|-5.7|3.6|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs SB-742457-15mg at Week 24||3.6|-5.7|0.655
71064954|NCT00708552|141638753|SUPERIORITY||Mean Difference (Net)|-1.5||||0.545|TWO_SIDED|95.0|-6.2|3.3|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs SB-742457-35mg at Week 24||3.3|-6.2|0.545
71064955|NCT00708552|141638753|SUPERIORITY||Mean Difference (Net)|2.4||||0.27|TWO_SIDED|95.0|-1.9|6.8|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs Donepezil at Week 24||6.8|-1.9|0.270
71064956|NCT00708552|141638754|SUPERIORITY||Mean Difference (Net)|1.5||||0.138|TWO_SIDED|95.0|-0.5|3.6|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs SB-742457-15mg at Week 24||3.6|-0.5|0.138
71111274|NCT02720523|141728991|SUPERIORITY||LS Mean Difference|-1.82|||<|0.001|TWO_SIDED|95.0|-2.59|-1.05|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||-1.05|-2.59|<0.001
70937995|NCT03122860|141375994|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.342|TWO_SIDED|95.0|-0.09|0.24|||ANCOVA|||||0.24|-0.09|0.342
71064957|NCT00708552|141638754|SUPERIORITY||Mean Difference (Net)|1.3||||0.216|TWO_SIDED|95.0|-0.7|3.2|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs SB-742457-35mg at Week 24||3.2|-0.7|0.216
71064958|NCT00708552|141638754|SUPERIORITY||Mean Difference (Net)|-0.1||||0.921|TWO_SIDED|95.0|-1.9|1.7|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs Donepezil at Week 24||1.7|-1.9|0.921
71064959|NCT00708552|141638754|SUPERIORITY||Mean Difference (Net)|-2.1||||0.41|TWO_SIDED|95.0|-7.0|2.9|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs SB-742457-15mg at Week 24||2.9|-7.0|0.410
71064960|NCT00708552|141638754|SUPERIORITY||Mean Difference (Net)|-1.1||||0.667|TWO_SIDED|95.0|-5.9|3.8|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs SB-742457-35mg at Week 24||3.8|-5.9|0.667
71064961|NCT00708552|141638754|SUPERIORITY||Mean Difference (Net)|2.7||||0.246|TWO_SIDED|95.0|-1.9|7.2|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs Donepezil at Week 24||7.2|-1.9|0.246
71064962|NCT00708552|141638755|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.146|TWO_SIDED|95.0|-0.1|0.6|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+ score, Placebo Vs SB-742457-15mg at Week 24||0.6|-0.1|0.146
71064963|NCT00708552|141638755|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.733|TWO_SIDED|95.0|-0.4|0.3|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+ score, Placebo Vs SB-742457-35mg at Week 24||0.3|-0.4|0.733
71064964|NCT00708552|141638755|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.145|TWO_SIDED|95.0|-0.5|0.1|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+ score, Placebo Vs Donepezil at Week 24||0.1|-0.5|0.145
71064965|NCT00708552|141638756|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.295|TWO_SIDED|95.0|-0.2|0.6|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+, Placebo Vs SB-742457-15mg at Week 24||0.6|-0.2|0.295
71064966|NCT00708552|141638756|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.495|TWO_SIDED|95.0|-0.5|0.2|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+, Placebo Vs SB-742457-35mg at Week 24||0.2|-0.5|0.495
71064967|NCT00708552|141638756|SUPERIORITY||Mean Difference (Net)|-0.3||||0.166|TWO_SIDED|95.0|-0.6|0.1|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+, Placebo Vs Donepezil at Week 24||0.1|-0.6|0.166
71064968|NCT00708552|141638757|SUPERIORITY||Mean Difference (Net)|0.1||||0.847|TWO_SIDED|95.0|-1.1|1.4|||Mixed model repeated measures|||ADAS-Cog Total Score, Placebo Vs SB-742457-15mg at Week 12||1.4|-1.1|0.847
70937996|NCT03122860|141375995|SUPERIORITY||Mean Difference (Final Values)|-2.13||||0.5|TWO_SIDED|95.0|-8.36|4.1|||ANCOVA|||||4.10|-8.36|0.500
70937997|NCT03122860|141375995|SUPERIORITY||Mean Difference (Final Values)|-5.54||||0.082|TWO_SIDED|95.0|-11.8|0.72|||ANCOVA|||||0.72|-11.80|0.082
71064969|NCT00708552|141638757|SUPERIORITY||Mean Difference (Net)|-0.1||||0.833|TWO_SIDED|95.0|-1.4|1.1|||Mixed Models Analysis|||ADAS-Cog Total Score, Placebo Vs SB-742457-35mg at Week 12||1.1|-1.4|0.833
71064970|NCT00708552|141638757|SUPERIORITY||Mean Difference (Net)|-0.5||||0.443|TWO_SIDED|95.0|-1.6|0.7|||Mixed model repeated measures|||ADAS-Cog Total Score, Placebo Vs Donepzil at Week 12||0.7|-1.6|0.443
70937998|NCT03122860|141375995|SUPERIORITY||Mean Difference (Final Values)|-1.94||||0.552|TWO_SIDED|95.0|-8.36|4.48|||ANCOVA|||||4.48|-8.36|0.552
70937999|NCT03122860|141375995|SUPERIORITY||Mean Difference (Final Values)|-6.86||||0.033|TWO_SIDED|95.0|-13.16|-0.56|||ANCOVA|||||-0.56|-13.16|0.033
71064971|NCT00708552|141638758|SUPERIORITY||Mean Difference (Net)|0.1||||0.32|TWO_SIDED|95.0|-0.1|0.3|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs SB-742457-15mg at Week 12||0.3|-0.1|0.320
71064972|NCT00708552|141638758|SUPERIORITY||Mean Difference (Net)|0.0||||0.927|TWO_SIDED|95.0|-0.2|0.2|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs SB-742457-35mg at Week 12||0.2|-0.2|0.927
71064973|NCT00708552|141638758|SUPERIORITY||Mean Difference (Net)|-0.2||||0.059|TWO_SIDED|95.0|-0.4|0.0|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs Donepzil at Week 12||0.0|-0.4|0.059
71064974|NCT00708552|141638759|SUPERIORITY||Mean Difference (Net)|-1.9||||0.257|TWO_SIDED|95.0|-5.2|1.4|||Mixed model repeated measures|||RBANS total score, Placebo Vs SB-742457-15mg at Week 12||1.4|-5.2|0.257
71064975|NCT00708552|141638759|SUPERIORITY||Mean Difference (Net)|0.9||||0.57|TWO_SIDED|95.0|-2.2|4.0|||Mixed model repeated measures|||RBANS total score, Placebo Vs SB-742457-35mg at Week 12||4.0|-2.2|0.570
71064976|NCT00708552|141638759|SUPERIORITY||Mean Difference (Net)|3.4||||0.031|TWO_SIDED|95.0|0.3|6.4|||Mixed model repeated measures|||RBANS total score, Placebo Vs Donepzil at Week 12||6.4|0.3|0.031
71064977|NCT00708552|141638760|SUPERIORITY||Mean Difference (Net)|0.2||||0.798|TWO_SIDED|95.0|-1.1|1.5|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs SB-742457-15mg at Week 12||1.5|-1.1|0.798
70938000|NCT03122860|141375995|SUPERIORITY||Mean Difference (Final Values)|0.45||||0.887|TWO_SIDED|95.0|-5.79|6.68|||ANCOVA|||||6.68|-5.79|0.887
71064978|NCT00708552|141638760|SUPERIORITY||Mean Difference (Net)|0.1||||0.918|TWO_SIDED|95.0|-1.3|1.4|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs SB-742457-35mg at Week 12||1.4|-1.3|0.918
71064979|NCT00708552|141638760|SUPERIORITY||Mean Difference (Net)|0.1||||0.924|TWO_SIDED|95.0|-1.2|1.3|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs Donepezil at Week 12||1.3|-1.2|0.924
71064980|NCT00708552|141638760|SUPERIORITY||Mean Difference (Net)|-0.8||||0.676|TWO_SIDED|95.0|-4.7|3.0|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs SB-742457-15mg at Week 12||3.0|-4.7|0.676
70938001|NCT03122860|141375996|SUPERIORITY||Mean Difference (Final Values)|-2.14||||0.473|TWO_SIDED|95.0|-7.99|3.72|||ANCOVA|||||3.72|-7.99|0.473
70938002|NCT03122860|141375996|SUPERIORITY||Mean Difference (Final Values)|-6.31||||0.04|TWO_SIDED|95.0|-12.33|-0.29|||ANCOVA|||||-0.29|-12.33|0.040
70938003|NCT03122860|141375996|SUPERIORITY||Mean Difference (Final Values)|1.72||||0.577|TWO_SIDED|95.0|-4.35|7.79|||ANCOVA|||||7.79|-4.35|0.577
70938004|NCT03122860|141375996|SUPERIORITY||Mean Difference (Final Values)|-8.95||||0.003|TWO_SIDED|95.0|-14.9|-3.01|||ANCOVA|||||-3.01|-14.90|0.003
70938005|NCT03122860|141375996|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.947|TWO_SIDED|95.0|-6.37|5.96|||ANCOVA|||||5.96|-6.37|0.947
70938006|NCT03122860|141375997|SUPERIORITY||Mean Difference (Final Values)|-3.05||||0.299|TWO_SIDED|95.0|-8.83|2.73|||ANCOVA|||||2.73|-8.83|0.299
70938007|NCT03122860|141375997|SUPERIORITY||Mean Difference (Final Values)|-7.18||||0.021|TWO_SIDED|95.0|-13.24|-1.12|||ANCOVA|||||-1.12|-13.24|0.021
70938008|NCT03122860|141375997|SUPERIORITY||Mean Difference (Final Values)|1.29||||0.675|TWO_SIDED|95.0|-4.75|7.33|||ANCOVA|||||7.33|-4.75|0.675
70938009|NCT03122860|141375997|SUPERIORITY||Mean Difference (Final Values)|-8.63||||0.006|TWO_SIDED|95.0|-14.7|-2.55|||ANCOVA|||||-2.55|-14.70|0.006
71064981|NCT00708552|141638760|SUPERIORITY||Mean Difference (Net)|3.1||||0.086|TWO_SIDED|95.0|-0.4|6.7|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs SB-742457-35mg at Week 12||6.7|-0.4|0.086
71064982|NCT00708552|141638760|SUPERIORITY||Mean Difference (Net)|4.2||||0.021|TWO_SIDED|95.0|0.6|7.7|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs Donepezil at Week 12||7.7|0.6|0.021
71064983|NCT00708552|141638761|SUPERIORITY||Mean Difference (Net)|0.1||||0.908|TWO_SIDED|95.0|-1.5|1.7|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs SB-742457-15mg at Week 12||1.7|-1.5|0.908
71064984|NCT00708552|141638761|SUPERIORITY||Mean Difference (Net)|-0.2||||0.826|TWO_SIDED|95.0|-1.7|1.4|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs SB-742457-35mg at Week 12||1.4|-1.7|0.826
71064985|NCT00708552|141638761|SUPERIORITY||Mean Difference (Net)|-1.2||||0.088|TWO_SIDED|95.0|-2.7|0.2|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs Donepezil at Week 12||0.2|-2.7|0.088
71064986|NCT00708552|141638761|SUPERIORITY||Mean Difference (Net)|-3.6||||0.053|TWO_SIDED|95.0|-7.3|0.0|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs SB-742457-15mg at Week 12||0.0|-7.3|0.053
71064987|NCT00708552|141638761|SUPERIORITY||Mean Difference (Net)|-0.4||||0.848|TWO_SIDED|95.0|-4.0|3.3|||Mixed Models Analysis|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs SB-742457-35mg at Week 12||3.3|-4.0|0.848
71064988|NCT00708552|141638761|SUPERIORITY||Mean Difference (Net)|4.7||||0.011|TWO_SIDED|95.0|1.1|8.2|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs Donepezil at Week 12||8.2|1.1|0.011
71064989|NCT00708552|141638762|SUPERIORITY||Mean Difference (Net)|0.1||||0.671|TWO_SIDED|95.0|-0.2|0.3|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CIBIC+ score, Placebo Vs SB-742457-15mg at Week 12||0.3|-0.2|0.671
71064990|NCT00708552|141638762|SUPERIORITY||Mean Difference (Net)|-0.1||||0.413|TWO_SIDED|95.0|-0.4|0.2|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CIBIC+ Total score, Placebo Vs SB-742457-35mg at Week 12||0.2|-0.4|0.413
70938010|NCT03122860|141375997|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.925|TWO_SIDED|95.0|-5.99|6.59|||ANCOVA|||||6.59|-5.99|0.925
70938011|NCT03122860|141375998|SUPERIORITY||Mean Difference (Final Values)|-0.58||||0.062|TWO_SIDED|95.0|-1.18|0.03|||ANCOVA|||||0.03|-1.18|0.062
70938012|NCT03122860|141375998|SUPERIORITY||Mean Difference (Final Values)|-0.96||||0.001|TWO_SIDED|95.0|-1.54|-0.37|||ANCOVA|||||-0.37|-1.54|0.001
70938013|NCT03122860|141375998|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.693|TWO_SIDED|95.0|-0.75|0.5|||ANCOVA|||||0.50|-0.75|0.693
70938014|NCT03122860|141375998|SUPERIORITY||Mean Difference (Final Values)|-0.78||||0.012|TWO_SIDED|95.0|-1.39|-0.17|||ANCOVA|||||-0.17|-1.39|0.012
70938015|NCT03122860|141375998|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.697|TWO_SIDED|95.0|-0.49|0.74|||ANCOVA|||||0.74|-0.49|0.697
70938016|NCT03122860|141375999|SUPERIORITY||Mean Difference (Final Values)|-3.32||||0.254|TWO_SIDED|95.0|-9.04|2.4|||ANCOVA|||||2.40|-9.04|0.254
70938017|NCT03122860|141375999|SUPERIORITY||Mean Difference (Final Values)|-6.86||||0.031|TWO_SIDED|95.0|-13.1|-0.63|||ANCOVA|||||-0.63|-13.10|0.031
70938018|NCT03122860|141375999|SUPERIORITY||Mean Difference (Final Values)|-1.46||||0.616|TWO_SIDED|95.0|-7.2|4.28|||ANCOVA|||||4.28|-7.20|0.616
71111275|NCT02720523|141728991|SUPERIORITY||LS Mean Difference|-1.96|||<|0.001|TWO_SIDED|95.0|-2.73|-1.18|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||-1.18|-2.73|<0.001
70938019|NCT03122860|141375999|SUPERIORITY||Mean Difference (Final Values)|-7.62||||0.01|TWO_SIDED|95.0|-13.41|-1.82|||ANCOVA|||||-1.82|-13.41|0.010
70938020|NCT03122860|141375999|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.961|TWO_SIDED|95.0|-5.74|5.46|||ANCOVA|||||5.46|-5.74|0.961
70938021|NCT03875729|141376000|SUPERIORITY||Mean Difference (Net)|0.1253|||<|0.001|TWO_SIDED|95.0|0.0852|0.1653||ITT: The ANCOVA model included treatment, age group at randomization, and baseline C-peptide ln(AUC+1) as independent variables. Missing data at Week 78 were multiply imputed using pattern-mixture model under the missing not at random assumption.|ANCOVA||Least squares mean (LSmean) difference = Teplizumab - Placebo|This study was designed to show a difference of at least a 40% in C-peptide response between teplizumab and placebo. In geometric means, this translates to a value of (1.4×0.28) = 0.392. Consequently, approximately 300 participants were planned for enrollment, assuming 2-sided α=0.05, 90% power, 2:1 randomization, and a 10% dropout rate.||0.1653|0.0852|<0.001
70938022|NCT03875729|141376000|SUPERIORITY||Mean Difference (Net)|0.1385|||<|0.001|TWO_SIDED|95.0|0.0994|0.1776||PP: The ANCOVA model included treatment, age group at randomization, and baseline C-peptide ln(AUC+1) as independent variables. Missing data at Week 78 were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA||Least squares mean (LSmean) difference = teplizumab - placebo|||0.1776|0.0994|<0.001
70938023|NCT03875729|141376001|SUPERIORITY||Mean Difference (Final Values)|-0.131||||0.085|TWO_SIDED|95.0|-0.28|0.018||ITT: ANCOVA model included treatment, age group at randomization, and screening peak C-peptide category as independent variables. Missing data at Week 78 were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA||LSmean difference = teplizumab - placebo.|||0.018|-0.280|0.085
71111276|NCT02340169|141728992|OTHER||||||||||||||||||Adrenal suppression rates in the evaluable population were 35% (21 out of 60), 43.3% (13 out of 30) and 20% (2 out of 10) in Cohorts 1, 2 a nd 3, respectively.|||
71111277|NCT01102491|141729013|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
70938024|NCT03875729|141376001|SUPERIORITY||Mean Difference (Final Values)|-0.167|||<|0.001|TWO_SIDED|95.0|-0.256|-0.078||PP: ANCOVA model included treatment, age group at randomization, and screening peak C-peptide category as independent variables. Missing data at Week 78 were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA||LSmean difference = teplizumab - placebo.|||-0.078|-0.256|<0.001
70938025|NCT03875729|141376002|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.606|TWO_SIDED|95.0|-0.42|0.24||ITT: ANCOVA model included treatment, age group at randomization, screening peak C-peptide category, baseline HbA1c as independent variables. Missing data were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA|||||0.24|-0.42|0.606
70938026|NCT03875729|141376002|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.454|TWO_SIDED|95.0|-0.46|0.2||PP: ANOVA model included treatment, age group at randomization, screening peak C-peptide category, baseline HbA1c as independent variables. Missing data were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA||LSmean difference = teplizumab - placebo.|||0.20|-0.46|0.454
70938027|NCT03875729|141376003|SUPERIORITY||Mean Difference (Final Values)|4.71||||0.151|TWO_SIDED|95.0|-1.72|11.15||ITT: The ANCOVA model included treatment, age group at randomization, and screening peak C-peptide category as independent variables. Missing data were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA||LSmean difference = teplizumab - placebo.|||11.15|-1.72|0.151
70938028|NCT03875729|141376003|SUPERIORITY||Mean Difference (Final Values)|6.17||||0.045|TWO_SIDED|95.0|0.13|12.22||PP: The ANCOVA model included treatment, age group at randomization, and screening peak C-peptide category as independent variables. Missing data were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA||LSmean difference = teplizumab - placebo.|||12.22|0.13|0.045
70938029|NCT03875729|141376004|SUPERIORITY||Rate ratio|1.1||||0.634|TWO_SIDED|95.0|0.74|1.64||ITT: Estimates and p-values were obtained from a negative binomial regression model using rate of hypoglycemic episodes as dependent variable and treatment, age group at randomization, and screening peak C-peptide category as independent variables.|Negative binomial regression model||Rate ratio = teplizumab / placebo.|||1.64|0.74|0.634
70938030|NCT03875729|141376004|SUPERIORITY||Rate ratio|1.09||||0.69|TWO_SIDED|95.0|0.72|1.65||PP: Estimates and p-values were obtained from a negative binomial regression model using rate of hypoglycemic episodes as dependent variable and treatment age group at randomization, and screening peak C-peptide category as independent variables.|Rate ratio||Rate ratio = teplizumab / placebo.|||1.65|0.72|0.690
71111278|NCT00276406|141729052|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|||Analysis was adjusted for BMI and baseline values and incorporated Bonferroni corrections.||||<0.01
71111279|NCT00276406|141729056|SUPERIORITY_OR_OTHER|||||||0.096||95.0|||||ANCOVA|||Analysis was adjusted for BMI and baseline values and incorporated Bonferroni corrections.||||0.096
71111280|NCT00276406|141729057|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANCOVA|||||||0.02
70938031|NCT00999336|141376016|OTHER|Geometric least squares means, ratios, and confidence intervals (CIs) were estimated from an analysis of covariance (ANCOVA) of natural log transformed values.|Ratio|1.89|||||TWO_SIDED|90.0|1.18|3.03|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 186 as a multiplier in the Modified Diet in Renal Disease Study Group (MDRD) equation.|||3.03|1.18|
70938032|NCT00999336|141376016|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.27|||||TWO_SIDED|90.0|1.43|3.59|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||3.59|1.43|
70938033|NCT00999336|141376016|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.63|||||TWO_SIDED|90.0|1.71|4.06|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||4.06|1.71|
70938034|NCT00999336|141376016|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.39|||||TWO_SIDED|90.0|0.888|2.18|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||2.18|0.888|
70938035|NCT00999336|141376016|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.94|||||TWO_SIDED|90.0|1.14|3.31|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||3.31|1.14|
71064991|NCT00708552|141638762|SUPERIORITY||Mean Difference (Net)|-0.1||||0.245|TWO_SIDED|95.0|-0.4|0.1|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CIBIC+ Total score, Placebo Vs Donepezil at Week 12||0.1|-0.4|0.245
71064992|NCT00708552|141638763|SUPERIORITY||Mean Difference (Net)|0.1||||0.369|TWO_SIDED|95.0|-0.2|0.4|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on CIBIC+ score, Placebo Vs SB-742457-15mg at Week 12||0.4|-0.2|0.369
71064993|NCT00708552|141638763|SUPERIORITY||Mean Difference (Net)|0.1||||0.55|TWO_SIDED|95.0|-0.2|0.4|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on CIBIC+ Total score, Placebo Vs SB-742457-35mg at Week 12||0.4|-0.2|0.550
71064994|NCT00708552|141638763|SUPERIORITY||Mean Difference (Net)|-0.3||||0.082|TWO_SIDED|95.0|-0.5|0.0|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on CIBIC+ Total score, Placebo Vs Donepezil at Week 12||0.0|-0.5|0.082
70938036|NCT00999336|141376016|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.44|||||TWO_SIDED|90.0|1.41|4.22|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||4.22|1.41|
70938037|NCT00999336|141376016|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.86|||||TWO_SIDED|90.0|1.74|4.7|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||4.7|1.74|
70938038|NCT00999336|141376016|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.47|||||TWO_SIDED|90.0|0.944|2.3|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||2.3|0.944|
70938039|NCT00999336|141376017|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.88|||||TWO_SIDED|90.0|1.05|3.35|||||Statistical comparison of Cmax on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||3.35|1.05|
71064995|NCT00708552|141638764|SUPERIORITY||Mean Difference (Net)|-0.7||||0.417|TWO_SIDED|95.0|-2.4|1.0|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs SB-742457-15mg at Week 12||1.0|-2.4|0.417
71064996|NCT00708552|141638764|SUPERIORITY||Mean Difference (Net)|0.3||||0.725|TWO_SIDED|95.0|-1.4|2.0|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs SB-742457-35mg at Week 12||2.0|-1.4|0.725
70938040|NCT00999336|141376017|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.32|||||TWO_SIDED|90.0|1.32|4.07|||||Statistical comparison of Cmax on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||4.07|1.32|
70938041|NCT00999336|141376017|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.52|||||TWO_SIDED|90.0|1.48|4.29|||||Statistical comparison of Cmax on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||4.29|1.48|
70938042|NCT00999336|141376017|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.34|||||TWO_SIDED|90.0|0.772|2.32|||||Statistical comparison of Cmax on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||2.32|0.772|
71064997|NCT00708552|141638764|SUPERIORITY||Mean Difference (Net)|0.6||||0.506|TWO_SIDED|95.0|-1.1|2.2|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs Donepezil at Week 12||2.2|-1.1|0.506
71064998|NCT00708552|141638764|SUPERIORITY||Mean Difference (Net)|-0.3||||0.723|TWO_SIDED|95.0|-2.3|1.6|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs SB-742457-15mg at Week 24||1.6|-2.3|0.723
71064999|NCT00708552|141638764|SUPERIORITY||Median Difference (Net)|-0.1||||0.919|TWO_SIDED|95.0|-2.2|2.0|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs SB-742457-35mg at Week 24||2.0|-2.2|0.919
71065000|NCT00708552|141638764|SUPERIORITY||Mean Difference (Net)|-0.1||||0.896|TWO_SIDED|95.0|-2.3|2.0|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs Donepezil at Week 24||2.0|-2.3|0.896
71065001|NCT00708552|141638765|SUPERIORITY||Mean Difference (Net)|-0.2||||0.594|TWO_SIDED|95.0|-0.9|0.5|||ANCOVA|||CSDD Total score, Placebo Vs SB-742457-15mg at Week 24||0.5|-0.9|0.594
71065002|NCT00708552|141638765|SUPERIORITY||Mean Difference (Net)|0.2||||0.523|TWO_SIDED|95.0|-0.5|0.9|||ANCOVA|||CSDD Total score, Placebo Vs SB-742457-35mg at Week 24||0.9|-0.5|0.523
71065003|NCT00708552|141638765|SUPERIORITY||Mean Difference (Net)|0.3||||0.429|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||CSDD Total score, Placebo Vs Donepezil at Week 24||1.0|-0.4|0.429
70938043|NCT00999336|141376017|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.96|||||TWO_SIDED|90.0|1.01|3.78|||||Statistical comparison of Cmax on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||3.78|1.01|
70938044|NCT00999336|141376017|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.38|||||TWO_SIDED|90.0|1.21|4.67|||||Statistical comparison of Cmax on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||4.67|1.21|
70938045|NCT00999336|141376017|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.69|||||TWO_SIDED|90.0|1.46|4.96|||||Statistical comparison of Cmax on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||4.96|1.46|
70938046|NCT00999336|141376017|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.37|||||TWO_SIDED|90.0|0.793|2.38|||||Statistical comparison of Cmax on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||2.38|0.793|
70938047|NCT02159352|141376027|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|0.384|||||TWO_SIDED|90.0|0.348|0.423||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed Cmax.||0.423|0.348|
70938048|NCT02159352|141376027|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|0.337|||||TWO_SIDED|90.0|0.306|0.371||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed Cmax.||0.371|0.306|
70938049|NCT02159352|141376028|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|0.703|||||TWO_SIDED|90.0|0.658|0.75||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed AUC(TAU).||0.750|0.658|
70938050|NCT02159352|141376028|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|0.577|||||TWO_SIDED|90.0|0.535|0.622||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed AUC(TAU).||0.622|0.535|
70938051|NCT02159352|141376031|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|0.768|||||TWO_SIDED|90.0|0.697|0.846||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed Cmax/D.||0.846|0.697|
70938052|NCT02159352|141376031|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|0.673|||||TWO_SIDED|90.0|0.611|0.742||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed Cmax/D.||0.742|0.611|
70938053|NCT02159352|141376032|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|1.406|||||TWO_SIDED|90.0|1.317|1.501||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed (AUC(TAU)/D).||1.501|1.317|
71065004|NCT00708552|141638766|SUPERIORITY||Mean Difference (Net)|0.0||||0.966|TWO_SIDED|95.0|-0.8|0.8|||ANCOVA|||MMSE Total score, Placebo Vs SB-742457-15mg at Week 24||0.8|-0.8|0.966
71065005|NCT00708552|141638766|SUPERIORITY||Mean Difference (Net)|0.3||||0.505|TWO_SIDED|95.0|-0.5|1.1|||ANCOVA|||MMSE Total score, Placebo Vs SB-742457-35mg at Week 24||1.1|-0.5|0.505
71065006|NCT00708552|141638766|SUPERIORITY||Mean Difference (Net)|0.8||||0.044|TWO_SIDED|95.0|0.0|1.6|||ANCOVA|||MMSE Total score, Placebo Vs Donepezil at Week 24||1.6|0.0|0.044
71065007|NCT00708552|141638767|SUPERIORITY||Mean Difference (Net)|0.0||||0.869|TWO_SIDED|95.0|-0.5|0.5|||Mixed model repeated measures|||Basic Score, Placebo Vs SB-742457-15mg at Week 12||0.5|-0.5|0.869
71065008|NCT00708552|141638767|SUPERIORITY||Mean Difference (Net)|0.2||||0.5|TWO_SIDED|95.0|-0.4|0.8|||Mixed model repeated measures|||Basic Score, Placebo Vs SB-742457-35mg at Week 12||0.8|-0.4|0.500
70938054|NCT02159352|141376032|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|1.154|||||TWO_SIDED|90.0|1.07|1.244||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed (AUC(TAU)/D).||1.244|1.070|
70938055|NCT01214109|141376038|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|82.62||||||90.0|74.45|91.69|||ANOVA|||0.125 mg t.i.d. IR is the reference treatment, 0.375 mg q.d. ER is the test treatment||91.69|74.45|
70938056|NCT01214109|141376038|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|96.17||||||90.0|69.33|133.42|||ANOVA|||0.5 mg t.i.d. IR is the reference treatment, 1.5 mg q.d. ER is the test treatment||133.42|69.33|
70938057|NCT01214109|141376039|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|88.01||||||90.0|80.76|95.92|||ANOVA|||0.125 mg t.i.d. IR vs. 0.375 mg q.d. ER 0.125 mg t.i.d. IR is the reference treatment, 0.375 mg q.d. ER is the test treatment||95.92|80.76|
70938058|NCT01214109|141376039|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|89.37||||||90.0|81.16|98.42|||ANOVA|||0.5 mg t.i.d. IR vs. 1.5 mg q.d. ER 0.5 mg t.i.d. IR is the reference treatment, 1.5 mg q.d. ER is the test treatment||98.42|81.16|
71065009|NCT00708552|141638767|SUPERIORITY||Mean Difference (Net)|0.3||||0.14|TWO_SIDED|95.0|-0.1|0.8|||Mixed model repeated measures|||Basic Score, Placebo Vs Donepezil at Week 12||0.8|-0.1|0.140
71065010|NCT00708552|141638767|SUPERIORITY||Mean Difference (Net)|0.0||||0.91|TWO_SIDED|95.0|-0.6|0.5|||Mixed model repeated measures|||Basic Score, Placebo Vs SB-742457-15mg at Week 24||0.5|-0.6|0.910
71065011|NCT00708552|141638767|SUPERIORITY||Mean Difference (Net)|0.1||||0.774|TWO_SIDED|95.0|-0.5|0.7|||Mixed model repeated measures|||Basic Score, Placebo Vs SB-742457-35mg at Week 24||0.7|-0.5|0.774
71065012|NCT00708552|141638767|SUPERIORITY||Mean Difference (Net)|-0.1||||0.726|TWO_SIDED|95.0|-0.7|0.5|||Mixed model repeated measures|||Basic Score, Placebo Vs Donepezil at Week 24||0.5|-0.7|0.726
71065013|NCT00708552|141638767|SUPERIORITY||Mean Difference (Net)|-0.8||||0.292|TWO_SIDED|95.0|-2.2|0.7|||Mixed model repeated measures|||Instrumental Score, Placebo Vs SB-742457-15mg at Week 12||0.7|-2.2|0.292
71078499|NCT01421147|141664985|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17||||0.32|TWO_SIDED|95.0|-0.52|0.17||P-value is for Baseline.|ANCOVA|||||0.17|-0.52|0.320
70938059|NCT01214109|141376040|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|88.82||||||90.0|79.89|98.76|||ANOVA|||0.125 mg t.i.d. IR vs. 0.375 mg q.d. ER 0.125 mg t.i.d. IR is the reference treatment, 0.375 mg q.d. ER is the test treatment||98.76|79.89|
70938060|NCT01214109|141376040|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|91.97||||||90.0|60.07|140.25|||ANOVA|||0.5 mg t.i.d. IR vs. 1.5 mg q.d. ER 0.5 mg t.i.d. IR is the reference treatment, 1.5 mg q.d. ER is the test treatment||140.25|60.07|
70938061|NCT01214109|141376041|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|92.84||||||90.0|83.8|102.86|||ANOVA|||0.125 mg t.i.d. IR is the reference treatment, 0.375 mg q.d. ER is the test treatment||102.86|83.8|
70938062|NCT01214109|141376041|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|95.05||||||90.0|84.88|106.43|||ANOVA|||0.5 mg t.i.d. IR is the reference treatment, 1.5 mg q.d. ER is the test treatment||106.43|84.88|
70938063|NCT04620733|141376058|SUPERIORITY||Risk Difference (RD)|41.7|||<|0.0001|TWO_SIDED|95.0|27.7|53.4||Two-sided p-value for pair-wise comparison was based on the CMH test adjusted for both randomization stratification variables (baseline ALP level: \< 350 U/L and ≥ 350 U/L; baseline Pruritus NRS: \< 4 and ≥ 4).|Cochran-Mantel-Haenszel|||||53.4|27.7|< 0.0001
70938064|NCT04620733|141376061|SUPERIORITY||Risk Difference (RD)|25.0|||<|0.0001|TWO_SIDED|95.0|18.3|33.2|||Cochran-Mantel-Haenszel||Two-sided p-value for pair-wise comparison is based on the Cochran Mantel Haenszel test adjusted for both stratification variables (baseline ALP level: \< 350 U/L and \>= 350 U/L; baseline pruritus NRS: \< 4 and \>= 4).|||33.2|18.3|< 0.0001
71065014|NCT00708552|141638767|SUPERIORITY||Mean Difference (Net)|0.0||||0.946|TWO_SIDED|95.0|-1.3|1.4|||Mixed model repeated measures|||Instrumental Score, Placebo Vs SB-742457-35mg at Week 12||1.4|-1.3|0.946
71065015|NCT00708552|141638767|SUPERIORITY||Mean Difference (Net)|0.2||||0.802|TWO_SIDED|95.0|-1.3|1.6|||Mixed model repeated measures|||Instrumental Score, Placebo Vs Donepezil at Week 12||1.6|-1.3|0.802
71065016|NCT00708552|141638767|SUPERIORITY||Mean Difference (Net)|-0.4||||0.636|TWO_SIDED|95.0|-2.1|1.3|||Mixed model repeated measures|||Instrumental Score, Placebo Vs SB-742457-15mg at Week 24||1.3|-2.1|0.636
71065017|NCT00708552|141638767|SUPERIORITY||Mean Difference (Net)|-0.3||||0.752|TWO_SIDED|95.0|-2.0|1.5|||Mixed model repeated measures|||Instrumental Score, Placebo Vs SB-742457-35mg at Week 24||1.5|-2.0|0.752
71065018|NCT00708552|141638767|SUPERIORITY||Mean Difference (Net)|-0.1||||0.92|TWO_SIDED|95.0|-1.9|1.7|||Mixed model repeated measures|||Instrumental Score, Placebo Vs Donepezil at Week 24||1.7|-1.9|0.920
70938065|NCT04620733|141376062|SUPERIORITY||Least Squares (LS) Mean Difference|-1.5||||0.0047|TWO_SIDED|95.0|-2.5|-0.5|||MMRM|Mixed-Effect Model Repeated Measure (MMRM)||||-0.5|-2.5|0.0047
70938066|NCT02221934|141376063|SUPERIORITY||Risk Difference (RD)|0.176||||0.002|TWO_SIDED|95.0|0.07|0.283|||Regression, Logistic||Difference in Responders between groups presented.|||0.283|0.070|0.002
71065019|NCT00708552|141638767|SUPERIORITY||Mean Difference (Net)|0.0||||0.972|TWO_SIDED|95.0|-0.7|0.6|||Mixed model repeated measures|||Total Independence Score, Placebo Vs SB-742457-15mg at Week 12||0.6|-0.7|0.972
71065020|NCT00708552|141638767|SUPERIORITY||Mean Difference (Net)|0.3||||0.378|TWO_SIDED|95.0|-0.4|0.9|||Mixed model repeated measures|||Total Independence Score, Placebo Vs SB-742457-35mg at Week 12||0.9|-0.4|0.378
70938067|NCT03072238|141376098|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0335|TWO_SIDED|95.0|0.61|0.98|||Log Rank|||||0.98|0.61|0.0335
71065021|NCT00708552|141638767|SUPERIORITY||Mean Difference (Net)|0.3||||0.346|TWO_SIDED|95.0|-0.3|0.9|||Mixed model repeated measures|||Total Independence Score, Placebo Vs Donepezil at Week 12||0.9|-0.3|0.346
71065022|NCT00708552|141638767|SUPERIORITY||Mean Difference (Net)|0.1||||0.72|TWO_SIDED|95.0|-0.6|0.9|||Mixed model repeated measures|||Total Independence Score, Placebo Vs SB-742457-15mg at Week 24||0.9|-0.6|0.720
71065023|NCT00708552|141638767|SUPERIORITY||Mean Difference (Net)|0.2||||0.598|TWO_SIDED|95.0|-0.6|1.0|||Mixed model repeated measures|||Total Independence Score, Placebo Vs SB-742457-35mg at Week 24||1.0|-0.6|0.598
71065024|NCT00708552|141638767|SUPERIORITY||Mean Difference (Net)|0.3||||0.48|TWO_SIDED|95.0|-0.5|1.1|||Mixed model repeated measures|||Total Independence Score, Placebo Vs Donepezil at Week 24||1.1|-0.5|0.480
71065025|NCT01609010|141638795|SUPERIORITY_OR_OTHER|||||||0.3023|||||||Log Rank|||||||0.3023
71065026|NCT01609010|141638796|SUPERIORITY_OR_OTHER|||||||0.3362|||||||Chi-squared|||Week 10, Cycle 1||||0.3362
71065027|NCT01609010|141638796|SUPERIORITY_OR_OTHER|||||||0.1157|||||||Chi-squared|||Week 16, Cycle 2||||0.1157
71065028|NCT01609010|141638797|SUPERIORITY_OR_OTHER|||||||0.854|||||||Chi-squared|||Week 10, Cycle 1||||0.8540
70938068|NCT03072238|141376099|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0431|TWO_SIDED|95.0|0.71|0.99|||Log Rank|||||0.99|0.71|0.0431
70938069|NCT03072238|141376100|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.5698|TWO_SIDED|95.0|0.76|1.17|||Log Rank|||||1.17|0.76|0.5698
70938070|NCT03072238|141376101|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.2515|TWO_SIDED|95.0|0.79|1.07|||Log Rank|||||1.07|0.79|0.2515
70938071|NCT03072238|141376102|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.601|TWO_SIDED|95.0|0.58|1.01|||Log Rank|||||1.01|0.58|0.6010
70938072|NCT03072238|141376103|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.1723|TWO_SIDED|95.0|0.72|1.06|||Log Rank|||||1.06|0.72|0.1723
70938073|NCT03072238|141376104|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.1566|TWO_SIDED|95.0|0.65|1.07|||Log Rank|||||1.07|0.65|0.1566
70938074|NCT03072238|141376105|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0419|TWO_SIDED|95.0|0.69|0.99|||Log Rank|||||0.99|0.69|0.0419
70938075|NCT03072238|141376106|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.3198|TWO_SIDED|95.0|0.89|1.45|||Log Rank|||||1.45|0.89|0.3198
70938076|NCT03072238|141376107|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.0071|TWO_SIDED|95.0|1.06|1.47|||Log Rank|||||1.47|1.06|0.0071
70938077|NCT03072238|141376108|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0045|TWO_SIDED|95.0|0.59|0.91|||Log Rank|||||0.91|0.59|0.0045
70938078|NCT03072238|141376109|SUPERIORITY||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.61|0.83|||Log Rank|||||0.83|0.61|< 0.0001
70938079|NCT03072238|141376110|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.1359|TWO_SIDED|95.0|0.57|1.08|||Log Rank|||||1.08|0.57|0.1359
70938080|NCT03072238|141376111|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.1398|TWO_SIDED|95.0|0.68|1.06|||Log Rank|||||1.06|0.68|0.1398
71065029|NCT01609010|141638797|SUPERIORITY_OR_OTHER|||||||0.0051|||||||Chi-squared|||Week 16, Cycle 2||||0.0051
71065030|NCT01609010|141638799|SUPERIORITY_OR_OTHER|||||||0.784|||||||Log Rank|Stratification by previous treatment for lymphoma (yes or no).||CR+CRu+PR||||0.7840
71065031|NCT01609010|141638799|SUPERIORITY_OR_OTHER|||||||0.4419|||||||Log Rank|Stratification by previous treatment for lymphoma (yes or no).||CR+CRu||||0.4419
71065032|NCT01609010|141638799|SUPERIORITY_OR_OTHER|||||||0.5942|||||||Log Rank|Stratification by previous treatment for lymphoma (yes or no).||CR only||||0.5942
71065033|NCT01609010|141638801|SUPERIORITY_OR_OTHER|||||||0.8946|||||||Log Rank|Stratified by previous treatment for lymphoma (yes or no).||||||0.8946
71065034|NCT01609010|141638803|SUPERIORITY_OR_OTHER|||||||0.4963|||||||Log Rank|Stratified by previous treatment for lymphoma (yes or no).||||||0.4963
71065035|NCT03150719|141638845|SUPERIORITY||Mean Difference|2.7|||||TWO_SIDED|95.0|1.0|4.4||||||||4.4|1.0|
71065036|NCT03150719|141638846|SUPERIORITY||Mean Difference|6.7|||||TWO_SIDED|95.0|2.5|10.9||||||||10.9|2.5|
71065037|NCT03150719|141638847|SUPERIORITY||Mean Difference|1.1|||||TWO_SIDED|95.0|-4.9|7.0||||||||7.0|-4.9|
71065038|NCT01790984|141638850|OTHER||General linear mixed model|2.0|||<|0.05|TWO_SIDED|||||Outcome measures were analysed as dependent variables in a general linear mixed model. All outcome variables in the model analysed were part of an priori hypothesis, and for this reason were not subject to adjustment for multiple comparisons.|Mixed Models Analysis|Mixed model analysis was appropriate for testing differences between 2 Groups on 2 Diets (NAFLD, Control,high \& low sugar diets).|Details of our statistical approach are given below.|The sample size of the NAFDL \& Control groups was based on primary outcome measures for a trace-labelling study of VLDL kinetics (VLDL1 apo B \& TAG production rates). From the literature there was an 80% probability that our study will detect a difference in the production rates of VLDL1 apo B of 30% (α=39%), and 26% for VLDL1-TAG (α=33%). A paired comparison of two diets (5% level), gave sample sizes of n=15 for each group. Note: All reported P-values were calculated.|For outcome measures for which there were four samples from each participant (pre- and post-diets, for each period), the post-diet measurements were analysed as dependent variables in a general linear mixed model, with the following fixed categorical, non-random, explanatory effects: period, treatment (low and high sugar diet), period by treatment interaction (to detect carry-over effects), liver fat level (NAFLD and Control) and treatment by liver fat level interaction. The pre-diet measurements for each period, and bodyweights (pre- and post-diets) were included as covariates in the model, with participant as a model random effect. For outcome measures for which there were two samples for each participant (post-diets; end of each dietary intervention period only), each measurement for the combined groups (NAFLD and controls), for the 2-period cross-over, were analysed in a general linear mixed model with the same fixed categorical effects and bodyweights as covariates.|||<0.05
71111281|NCT00276406|141729058|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANCOVA|||Bowel diaries were analyzed by computing the mean scores for the 9-day baseline period and separately for the last 7 days of the treatment period (i.e., when the pyridostigmine dose was stable in each subject.) Individual subject treatment period mean bowel function scores were then compared using a similar ANCOVA model, with the corresponding individual subject baseline mean bowel function score and gender as covariates.||||0.005
71111282|NCT00276406|141729059|SUPERIORITY_OR_OTHER||||||<|0.04||95.0|||||ANCOVA|||Bowel diaries were analyzed by computing the mean scores for the 9-day baseline period and separately for the last 7 days of the treatment period (i.e., when the pyridostigmine dose was stable in each subject.) Individual subject treatment period mean bowel function scores were then compared using a similar ANCOVA model, with the corresponding individual subject baseline mean bowel function score and gender as covariates.||||<0.04
71111283|NCT02297815|141729064|SUPERIORITY_OR_OTHER||Score difference|-1.4||||0.008|TWO_SIDED|95.0|-2.44|-0.36|||Weighted linear regression|Propensity-score based full matching performed. Average treatment effect weights calculated and applied to a weighted linear regression.|Narrow antibiotics is the reference group. A score difference less than zero indicates that broad spectrum antibiotics are associated with a lower (poorer) health related quality of life score.|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted linear regression.||-0.36|-2.44|0.008
71065039|NCT01790984|141638851|OTHER||General linear mixed model|11.0|||<|0.05|TWO_SIDED|||||Outcome measures were analysed as dependent variables in a general linear mixed model. All outcome variables in the model analysed were part of an priori hypothesis, and for this reason were not subject to adjustment for multiple comparisons.|Mixed Models Analysis|Mixed model analysis was appropriate for testing the impact of 'Diet' (high and low sugar) and Group (NAFLD and Control) status on outcome variables.|Details of our statistical analyses are given below.|The sample size for NAFLD \& Control groups was based on primary outcome measures for a trace-labelling study of VLDL kinetics (VLDL1 apo B and triacylglycerol production rates). From the literature there was an 80% probability that our study will detect a difference in the production rates of VLDL1 apo B of 30% (α=39%), and 26% for VLDL1-TG (α=33%). A paired comparison of two diets (5% level) produced sample sizes of n=15 for each group. Note: All reported P-values were calculated.|For outcome measures for which there were four samples from each participant (pre- and post-diets, for each period), the post-diet measurements were analysed as dependent variables in a general linear mixed model, with the following fixed categorical, non-random, explanatory effects: period, treatment (low and high sugar diet), period by treatment interaction (to detect carry-over effects), liver fat level (NAFLD and Control) and treatment by liver fat level interaction. The pre-diet measurements for each period, and bodyweights (pre- and post-diets) were included as covariates in the model, with participant as a model random effect. For outcome measures for which there were two samples for each participant (post-diets; end of each dietary intervention period only), each measurement for the combined groups (NAFLD and controls), for the 2-period cross-over, were analysed in a general linear mixed model with the same fixed categorical effects and bodyweights as covariates.|||<0.05
71078500|NCT01421147|141664985|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.781|TWO_SIDED|95.0|-0.33|0.25||P-value is for Endpoint, up to 24 weeks.|ANCOVA|||||0.25|-0.33|0.781
71078501|NCT01421147|141664985|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.26||||0.06|TWO_SIDED|95.0|-0.53|0.01||P-value is for Endpoint, up to 52 weeks.|ANCOVA|||||0.01|-0.53|0.060
71078502|NCT01421147|141664986|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.823|TWO_SIDED|95.0|-0.23|0.29||P-value is for change at 6 weeks.|ANCOVA|||||0.29|-0.23|0.823
71078503|NCT01421147|141664986|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.541|TWO_SIDED|95.0|-0.25|0.47||P-value is for change at 12 weeks.|ANCOVA|||||0.47|-0.25|0.541
70938081|NCT03072238|141376112|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.8239|TWO_SIDED|95.0|0.61|1.48|||Log Rank|||||1.48|0.61|0.8239
71065040|NCT01790984|141638852|OTHER||General linear mixed model|110.0|||<|0.05|TWO_SIDED|||||Outcome measures were analysed as dependent variables in a general linear mixed model. All outcome variables in the model analysed were part of an priori hypothesis, and for this reason were not subject to adjustment for multiple comparisons.|Mixed Models Analysis|Mixed model analysis was appropriate for testing the impact of 'Diet' (high and low sugar) and Group (NAFLD and Control) status on outcome variables.|Details of our statistical analyses are given below.|The sample size of the NAFDL \& Control groups was based on primary outcome measures for a trace-labelling study of VLDL kinetics (VLDL1 apo B \& TAG production rates). From the literature there was an 80% probability that our study will detect a difference in the production rates of VLDL1 apo B of 30% (α=39%), and 26% for VLDL1-TG (α=33%). A paired comparison of two diets (5% level), gave sample sizes of n=15 for each group. Note: All reported P-values were calculated.|For outcome measures for which there were four samples from each participant (pre- and post-diets, for each period), the post-diet measurements were analysed as dependent variables in a general linear mixed model, with the following fixed categorical, non-random, explanatory effects: period, treatment (low and high sugar diet), period by treatment interaction (to detect carry-over effects), liver fat level (NAFLD and Control) and treatment by liver fat level interaction. The pre-diet measurements for each period, and bodyweights (pre- and post-diets) were included as covariates in the model, with participant as a model random effect. For outcome measures for which there were two samples for each participant (post-diets; end of each dietary intervention period only), each measurement for the combined groups (NAFLD and controls), for the 2-period cross-over, were analysed in a general linear mixed model with the same fixed categorical effects and bodyweights as covariates.|||<0.05
71065041|NCT01790984|141638853|OTHER||General linear mixed model|0.26|||<|0.05|TWO_SIDED|||||Outcome measures were analysed as dependent variables in a general linear mixed model. All outcome variables in the model analysed were part of an priori hypothesis, and for this reason were not subject to adjustment for multiple comparisons.|Mixed Models Analysis|Mixed model analysis was appropriate for testing the impact of 'Diet' (high and low sugar) and Group (NAFLD and Control) status on outcome variables.|Details of our statistical approach are given below.|The sample size of the NAFDL \& Control groups was based on primary outcome measures for a trace-labelling study of VLDL kinetics (VLDL1 apo B \& TAG production rates). From the literature there was an 80% probability that our study will detect a difference in the production rates of VLDL1 apo B of 30% (α=39%), and 26% for VLDL1-TG (α=33%). A paired comparison of two diets (5% level), gave sample sizes of n=15 for each group. Note: All reported P-values were calculated.|For outcome measures for which there were four samples from each participant (pre- and post-diets, for each period), the post-diet measurements were analysed as dependent variables in a general linear mixed model, with the following fixed categorical, non-random, explanatory effects: period, treatment (low and high sugar diet), period by treatment interaction (to detect carry-over effects), liver fat level (NAFLD and Control) and treatment by liver fat level interaction. The pre-diet measurements for each period, and bodyweights (pre- and post-diets) were included as covariates in the model, with participant as a model random effect. For outcome measures for which there were two samples for each participant (post-diets; end of each dietary intervention period only), each measurement for the combined groups (NAFLD and controls), for the 2-period cross-over, were analysed in a general linear mixed model with the same fixed categorical effects and bodyweights as covariates.|||<0.05
71065042|NCT01790984|141638854|OTHER||General linear mixed model|10.0|||>|0.05|TWO_SIDED|||||Outcome measures were analysed as dependent variables in a general linear mixed model. All outcome variables in the model analysed were part of an priori hypothesis, and for this reason were not subject to adjustment for multiple comparisons.|Mixed Models Analysis|Mixed model analysis was appropriate for testing the impact of 'Diet' (high and low sugar) and Group (NAFLD and Control) status on outcome variables|Details of our statistical analyses are described below.|The sample size of the NAFDL \& Control groups was based on primary outcome measures for a trace-labelling study of VLDL kinetics (VLDL1 apo B \& TAG production rates). From the literature there was an 80% probability that our study will detect a difference in the production rates of VLDL1 apo B of 30% (α=39%), and 26% for VLDL1-TG (α=33%). A paired comparison of two diets (5% level), gave sample sizes of n=15 for each group. Note: All reported P-values were calculated.|For outcome measures for which there were four samples from each participant (pre- and post-diets, for each period), the post-diet measurements were analysed as dependent variables in a general linear mixed model, with the following fixed categorical, non-random, explanatory effects: period, treatment (low and high sugar diet), period by treatment interaction (to detect carry-over effects), liver fat level (NAFLD and Control) and treatment by liver fat level interaction. The pre-diet measurements for each period, and bodyweights (pre- and post-diets) were included as covariates in the model, with participant as a model random effect. For outcome measures for which there were two samples for each participant (post-diets; end of each dietary intervention period only), each measurement for the combined groups (NAFLD and controls), for the 2-period cross-over, were analysed in a general linear mixed model with the same fixed categorical effects and bodyweights as covariates.|||>0.05
71111284|NCT02297815|141729065|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.4||||0.39|TWO_SIDED|95.0|-3.1|7.9|||Weighted logistic regression|Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.|Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.||7.9|-3.1|0.39
71078504|NCT01421147|141664986|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17||||0.435|TWO_SIDED|95.0|-0.25|0.59||P-value is for change at 18 weeks.|ANCOVA|||||0.59|-0.25|0.435
71078505|NCT01421147|141664986|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24||||0.32|TWO_SIDED|95.0|-0.23|0.71||P-value is for change at Endpoint, up to 24 weeks.|ANCOVA|||||0.71|-0.23|0.320
71078506|NCT01421147|141664986|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34||||0.253|TWO_SIDED|95.0|-0.25|0.93||P-value is for change at Endpoint, up to 52 weeks.|ANCOVA|||||0.93|-0.25|0.253
71078507|NCT01421147|141664987|SUPERIORITY_OR_OTHER||LS Mean Difference|0.64||||0.401|TWO_SIDED|95.0|-0.86|2.15||P-value is for Baseline-Behavior TS.|ANCOVA|||||2.15|-0.86|0.401
71078508|NCT01421147|141664987|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.778|TWO_SIDED|95.0|-1.16|1.55||P-value is for 24 weeks-Behavior TS|ANCOVA|||||1.55|-1.16|0.778
71078509|NCT01421147|141664987|SUPERIORITY_OR_OTHER||LS Mean Difference|0.16||||0.804|TWO_SIDED|95.0|-1.12|1.45||P-value is for Endpoint, up to 52 weeks-Behavior TS.|ANCOVA|||||1.45|-1.12|0.804
71078510|NCT01421147|141664987|SUPERIORITY_OR_OTHER||LS Mean Difference|1.21||||0.304||95.0|-1.1|3.51||P-value is for Baseline-Worry TS.|ANCOVA|||||3.51|-1.10|0.304
70938082|NCT03072238|141376113|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.6018|TWO_SIDED|95.0|0.66|1.27|||Log Rank|||||1.27|0.66|0.6018
70938083|NCT03072238|141376114|SUPERIORITY||Difference in Overall Response Rate|20.93||||0.003|TWO_SIDED|95.0|6.2|35.65|||Cochran-Mantel-Haenszel|||||35.65|6.20|0.0030
70938084|NCT03072238|141376115|SUPERIORITY||Difference in Overall Response Rate|16.46||||0.0008|TWO_SIDED|95.0|6.66|26.27|||Cochran-Mantel-Haenszel|||||26.27|6.66|0.0008
70938085|NCT03072238|141376118|SUPERIORITY||Difference in Overall Response Rate|11.81||||0.0012|TWO_SIDED|95.0|4.34|19.29|||Cochran-Mantel-Haenszel|||||19.29|4.34|0.0012
70938086|NCT03072238|141376119|SUPERIORITY||Difference in Overall Response Rate|5.87||||0.0178|TWO_SIDED|95.0|0.83|10.9|||Cochran-Mantel-Haenszel|||||10.90|0.83|0.0178
70938087|NCT03072238|141376120|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0246|TWO_SIDED|95.0|0.45|0.95|||Log Rank|||||0.95|0.45|0.0246
70938088|NCT02489799|141376133|EQUIVALENCE|The study was powered based on two former studies utilizing RIAS, (both powered =.8 and alpha =.05). With a 0.6 effect size, the required sample size is 72 patients (36 per group) for a one-tailed test of study hypotheses (power =.8 and alpha =.05).|Incidence Rate Ratio|1.06||||0.545|TWO_SIDED|95.0|0.87|1.3|||Poisson model using GEE|We fit a Poisson model using generalized estimating equations. No adjustments were made for degrees of freedom.|The incidence rate ratio compares intervention to control.|We employed two ways of interpreting this data. The first treats the outcome continuously, which is described in the results section. Here we describe the outcome treating it as a ratio. We created a variable representing the numerator of the ratio (type 1) and the denominator of the ratio (type 2) thereby treating the information in both the numerator and denominator as random (each a Poisson variable).||1.30|0.87|0.545
70938089|NCT01241448|141376143|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.29||||0.094|TWO_SIDED|90.0|-0.58|-0.01||No multiplicity adjustments were used to calculate the p-value.|Mixed Models Analysis|||Sixty-five randomized patients (45 completers) per arm were expected to provide at least 90% power to detect 0.8% HbA1c difference with placebo assuming a SD for change in HbA1c of 1.2% (0.05 1-sided type I error).||-0.01|-0.58|0.094
71078511|NCT01421147|141664987|SUPERIORITY_OR_OTHER||LS Mean Difference|1.12||||0.323|TWO_SIDED|95.0|-1.1|3.34||P-value is for 24 weeks-Worry TS.|ANCOVA|||||3.34|-1.10|0.323
71111285|NCT02297815|141729066|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.5||||0.59|TWO_SIDED|95.0|-3.9|6.8|||Weighted logistic regression|Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.|Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.||6.8|-3.9|0.59
70938090|NCT01241448|141376143|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.62|||<|0.001|TWO_SIDED|90.0|-0.9|-0.34||No multiplicity adjustments were used to calculate the p-value.|Mixed Models Analysis|||Sixty-five randomized patients (45 completers) per arm were expected to provide at least 90% power to detect 0.8% HbA1c difference with placebo assuming a SD for change in HbA1c of 1.2% (0.05 1-sided type I error).||-0.34|-0.90|<0.001
70938091|NCT01241448|141376143|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.77|||<|0.01|TWO_SIDED|90.0|-1.05|-0.48||No multiplicity adjustments were used to calculate the p-value.|Mixed Models Analysis|||Sixty-five randomized patients (45 completers) per arm were expected to provide at least 90% power to detect 0.8% HbA1c difference with placebo assuming a SD for change in HbA1c of 1.2% (0.05 1-sided type I error).||-0.48|-1.05|<0.01
70938092|NCT01690000|141376161|SUPERIORITY_OR_OTHER||||||<|0.05||||||The p-value was calculated|t-test, 2 sided|||The p-value was calculated||||<0.05
70938093|NCT04540952|141376205|SUPERIORITY|Power analysis indicated that with a sample size of 34 per arm, would provide 81% power to detect an effect size of 0.7 (0.7\*SD of fluid deficit) with a two-sided, two sample t test (a=0.05).|Mean Difference (Final Values)|11.3||||0.93|TWO_SIDED|95.0|-260.7|283.4|||t-test, 2 sided|||||283.4|-260.7|0.93
70938094|NCT02291861|141376211|SUPERIORITY||LSM difference|-1.9||||0.001|TWO_SIDED|95.0|-3.09|-0.79||Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~The primary endpoint compared the change in total motor AIMS score from baseline to week 12 between the SD-809 36 mg/day group and the placebo group."||-0.79|-3.09|0.001
70938095|NCT02291861|141376211|SUPERIORITY||LSM difference|-1.8||||0.003|TWO_SIDED|95.0|-3.0|-0.63||Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~This key secondary endpoint compared the change in total motor AIMS score from baseline to week 12 between the SD-809 24 mg/day group and the placebo group, and is the third analysis in the fixed-sequence."||-0.63|-3.00|0.003
70938096|NCT02291861|141376211|SUPERIORITY||LSM difference|-0.7||||0.217|TWO_SIDED|95.0|-1.84|0.42||Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~This key secondary endpoint compared the change in total motor AIMS score from baseline to week 12 between the SD-809 12 mg/day group and the placebo group, and is the fifth analysis in the fixed-sequence."||0.42|-1.84|0.217
71078512|NCT01421147|141664987|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.824||95.0|-1.92|2.41||P-value is for Endpoint, up to 52 weeks-Worry TS.|ANCOVA|||||2.41|-1.92|0.824
71078513|NCT01421147|141664988|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.77||||0.681|TWO_SIDED|95.0|-4.42|2.89||P-value is for IR-Baseline.|ANCOVA|||||2.89|-4.42|0.681
71078514|NCT01421147|141664988|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56||||0.744|TWO_SIDED|95.0|-2.79|3.9||P-value is for IR-24 weeks.|ANCOVA|||||3.90|-2.79|0.744
70941764|NCT04748445|141383935|OTHER||Slope|-2.66|STANDARD_ERROR_OF_MEAN|9.22||0.0046|TWO_SIDED|90.0|-4.188|-1.132|||Mixed Models Analysis|||READ\_MFCC 1st order delta 01 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-3. For estimated value it was 10\^-4).||-1.132|-4.188|0.0046
71065043|NCT01790984|141638855|OTHER||General linear mixed model|0.28|||<|0.05|TWO_SIDED|||||Outcome measures were analysed as dependent variables in a general linear mixed model. All outcome variables in the model analysed were part of an priori hypothesis, and for this reason were not subject to adjustment for multiple comparisons.|Mixed Models Analysis|Mixed model analysis was appropriate for testing the impact of 'Diet' (high and low sugar) and Group (NAFLD and Control) status on outcome variables.|Details of our statistical analyses are given below.|The sample size of the NAFDL \& Control groups was based on primary outcome measures for a trace-labelling study of VLDL kinetics (VLDL1 apo B \& TAG production rates). From the literature there was an 80% probability that our study will detect a difference in the production rates of VLDL1 apo B of 30% (α=39%), and 26% for VLDL1-TG (α=33%). A paired comparison of two diets (5% level), gave sample sizes of n=15 for each group. Note: All reported P-values were calculated.|For outcome measures for which there were four samples from each participant (pre- and post-diets, for each period), the post-diet measurements were analysed as dependent variables in a general linear mixed model, with the following fixed categorical, non-random, explanatory effects: period, treatment (low and high sugar diet), period by treatment interaction (to detect carry-over effects), liver fat level (NAFLD and Control) and treatment by liver fat level interaction. The pre-diet measurements for each period, and bodyweights (pre- and post-diets) were included as covariates in the model, with participant as a model random effect. For outcome measures for which there were two samples for each participant (post-diets; end of each dietary intervention period only), each measurement for the combined groups (NAFLD and controls), for the 2-period cross-over, were analysed in a general linear mixed model with the same fixed categorical effects and bodyweights as covariates.|||<0.05
71065044|NCT00386360|141639048|SUPERIORITY_OR_OTHER||LS Mean Difference|0.231||||0.7096|TWO_SIDED|95.0|-0.995|1.458|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||1.458|-0.995|0.7096
71065045|NCT00386360|141639049|SUPERIORITY_OR_OTHER||LS Mean Difference|0.543||||0.2973|TWO_SIDED|95.0|-0.485|1.571|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||1.571|-0.485|0.2973
71065046|NCT00386360|141639050|SUPERIORITY_OR_OTHER||LS Mean Difference|0.485||||0.1275|TWO_SIDED|95.0|-0.141|1.11|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||1.110|-0.141|0.1275
71065047|NCT00386360|141639051|SUPERIORITY_OR_OTHER||LS Mean Difference|0.664||||0.336|TWO_SIDED|95.0|-0.697|2.025|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||2.025|-0.697|0.3360
71065048|NCT00386360|141639052|SUPERIORITY_OR_OTHER||LS Mean Difference|0.334||||0.4565|TWO_SIDED|95.0|-0.551|1.219|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||1.219|-0.551|0.4565
71065049|NCT00386360|141639053|SUPERIORITY_OR_OTHER||LS Mean Difference|0.611||||0.0614|TWO_SIDED|95.0|-0.03|1.252|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||1.252|-0.030|0.0614
71078515|NCT01421147|141664988|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.94||||0.582|TWO_SIDED|95.0|-4.29|2.41||P-value is for IR-Endpoint, up to 52 weeks.|ANCOVA|||||2.41|-4.29|0.582
71078516|NCT01421147|141664988|SUPERIORITY_OR_OTHER||LS Mean Difference|0.82||||0.694|TWO_SIDED|95.0|-3.26|4.89||P-value is for LF-Baseline.|ANCOVA|||||4.89|-3.26|0.694
71078517|NCT01421147|141664988|SUPERIORITY_OR_OTHER||LS Mean Difference|0.84||||0.673|TWO_SIDED|95.0|-3.08|4.77||P-value is for LF-24 weeks.|ANCOVA|||||4.77|-3.08|0.673
71078518|NCT01421147|141664988|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.91||||0.645|TWO_SIDED|95.0|-4.79|2.97||P-value is for LF-Endpoint, up to 52 weeks.|ANCOVA|||||2.97|-4.79|0.645
71078519|NCT01421147|141664988|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.961|TWO_SIDED|95.0|-3.62|3.81||P-value is for GC-Baseline.|ANCOVA|||||3.81|-3.62|0.961
71078520|NCT01421147|141664988|SUPERIORITY_OR_OTHER||LS Mean Difference|1.25||||0.463|TWO_SIDED|95.0|-2.1|4.61||P-value is for GC-24 weeks.|ANCOVA|||||4.61|-2.10|0.463
71065050|NCT00386360|141639054|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06||||0.9212|TWO_SIDED|95.0|-1.258|1.138|||ANOVA|LS means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||1.138|-1.258|0.9212
71065051|NCT00386360|141639055|SUPERIORITY_OR_OTHER||LS Mean Difference|3.27|||<|0.0001|TWO_SIDED|95.0|2.231|4.31|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||4.310|2.231|<0.0001
71065052|NCT00386360|141639056|SUPERIORITY_OR_OTHER||LS Mean Difference|1.444|||<|0.0001|TWO_SIDED|95.0|0.748|2.14|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||2.140|0.748|<0.0001
71065053|NCT00386360|141639057|SUPERIORITY_OR_OTHER||LS Mean Difference|1.408||||0.0036|TWO_SIDED|95.0|0.469|2.348|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||2.348|0.469|0.0036
71065054|NCT00386360|141639058|SUPERIORITY_OR_OTHER||LS Mean Difference|1.458||||0.0087|TWO_SIDED|95.0|0.375|2.541|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||2.541|0.375|0.0087
71065055|NCT00386360|141639059|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.54||||0.0002|TWO_SIDED|95.0|-59.957|-19.123|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||-19.123|-59.957|0.0002
71065056|NCT00386360|141639060|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.269|||<|0.0001|TWO_SIDED|95.0|-51.3|-29.238|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||-29.238|-51.300|<0.0001
71065057|NCT00386360|141639061|SUPERIORITY_OR_OTHER||LS Mean Difference|0.092||||0.1385|TWO_SIDED|95.0|-0.03|0.213|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||0.213|-0.030|0.1385
71065058|NCT02230904|141639062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.115|STANDARD_DEVIATION|1.635|||TWO_SIDED|||||||||The change in average adhesiveness score was average score for Treatment B minus average score for Treatment A.||||
71065059|NCT02230904|141639069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.442|STANDARD_DEVIATION|0.895|||TWO_SIDED|||||||||The change in average adhesiveness score was average score for Treatment B minus average score for Treatment A.||||
71065060|NCT00232739|141639095|SUPERIORITY_OR_OTHER||Primary analysis posterior probability|0.9926||||||||||The primary analysis of comparing Sirolimus stent with POBA using Bayesian regression model yields that Sirolimus is superior to POBA in reducing the BAR risk.|Bayesian regression model|Multi-level Bayesian regression model was used in the secondary analysis|Secondary analysis for comparing Sirolimus stent with BMS1 and BMS2 signified that Sirolimus stent is superior to POBA, BMS1 and BMS2 in reducing the BAR risk.|Historical control groups consist of propensity-scored matched cohorts (100 patients each, based on Reference Vessel Diameter, lesion length, diabetes, left anterior artery diseased vessel, and gender) of plain old balloon angioplasty (POBA), first generation (Palmaz-Schatz) bare metal stent (BMS1), and BX VELOCITY bare metal stent (BMS2). Study showed the risk of 6-month in-lesion binary angiographic restenosis (BAR) was much lower for the 2.25 Sirolimus stent compared with POBA, BMS1 or BMS2.||||
71078521|NCT01421147|141664988|SUPERIORITY_OR_OTHER||LS Mean Difference|0.91||||0.609|TWO_SIDED|95.0|-2.59|4.41||P-value is for GC-Endpoint, up to 52 weeks.|ANCOVA|||||4.41|-2.59|0.609
71065061|NCT00463047|141639111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|0.18|0.29|||Mixed effects ANOVA|Crossover analysis||The statistical hypothesis to be tested was:HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID15 for double-blind episodes for which patients use FBT and oxycodone (OXY), respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.29|0.18|<0.0001
71078522|NCT01421147|141664988|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.61||||0.708|TWO_SIDED|95.0|-3.81|2.59||P-value is for HC-Baseline.|ANCOVA|||||2.59|-3.81|0.708
71078523|NCT01421147|141664988|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.03||||0.51|TWO_SIDED|95.0|-4.09|2.03||P-value is for HC-24 weeks.|ANCOVA|||||2.03|-4.09|0.510
71078524|NCT01421147|141664988|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.26||||0.422|TWO_SIDED|95.0|-4.34|1.82||P-value is for HC-Endpoint, up to 52 weeks.|ANCOVA|||||1.82|-4.34|0.422
71078525|NCT01421147|141664988|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.53||||0.367|TWO_SIDED|95.0|-4.85|1.8||P-value is for IDD-Baseline.|ANCOVA|||||1.80|-4.85|0.367
71078526|NCT01421147|141664988|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41||||0.786|TWO_SIDED|95.0|-2.54|3.35||P-value is for IDD-24 weeks.|ANCOVA|||||3.35|-2.54|0.786
71078527|NCT01421147|141664988|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29||||0.845|TWO_SIDED|95.0|-3.16|2.59||P-value is for IDD-Endpoint, up to 52 weeks.|ANCOVA|||||2.59|-3.16|0.845
71078528|NCT01421147|141664988|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.59||||0.676|TWO_SIDED|95.0|-3.36|2.18||P-value is for ITSQ Total-Baseline.|ANCOVA|||||2.18|-3.36|0.676
71078529|NCT01421147|141664988|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.862|TWO_SIDED|95.0|-2.33|2.78||P-value is for ITSQ Total-24 weeks.|ANCOVA|||||2.78|-2.33|0.862
71078530|NCT01421147|141664988|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54||||0.685|TWO_SIDED|95.0|-3.15|2.07||P-value is for ITSQ Total-Endpoint, up to 52 weeks.|ANCOVA|||||2.07|-3.15|0.685
71078531|NCT01421147|141664989|SUPERIORITY_OR_OTHER||LS Mean Difference|0.014||||0.235|TWO_SIDED|95.0|-0.009|0.036||P-value is for Endpoint, up to 24 wk-Basal Insulin.|ANCOVA|||||0.036|-0.009|0.235
71078532|NCT01421147|141664989|SUPERIORITY_OR_OTHER||LS Mean Difference|0.006||||0.726|TWO_SIDED|95.0|-0.026|0.038||P-value is for Endpoint, up to 24 wk-Bolus Insulin.|ANCOVA|||||0.038|-0.026|0.726
71078533|NCT01421147|141664989|SUPERIORITY_OR_OTHER||LS Mean Difference|0.019||||0.377|TWO_SIDED|95.0|-0.023|0.062||P-value is for Endpoint, up to 24 wk-Total Insulin.|ANCOVA|||||0.062|-0.023|0.377
71078534|NCT01421147|141664989|SUPERIORITY_OR_OTHER||LS Mean Difference|0.018||||0.159|TWO_SIDED|95.0|-0.007|0.042||P-value is for Endpoint, up to 52 wk-Basal Insulin.|ANCOVA|||||0.042|-0.007|0.159
71078535|NCT01421147|141664989|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.001||||0.957|TWO_SIDED|95.0|-0.034|0.032||P-value is for Endpoint, up to 52 wk-Bolus Insulin.|ANCOVA|||||0.032|-0.034|0.957
71078536|NCT01421147|141664989|SUPERIORITY_OR_OTHER||LS Mean Difference|0.017||||0.45|TWO_SIDED|95.0|-0.028|0.062||P-value is for Endpoint, up to 52 wk-Total Insulin.|ANCOVA|||||0.062|-0.028|0.450
71078537|NCT01421147|141664990|SUPERIORITY_OR_OTHER||LS Mean Difference|1.724||||0.096|TWO_SIDED|95.0|-0.308|3.755||P-value is for Endpoint, up to 24 wk-Basal Insulin.|ANCOVA|||||3.755|-0.308|0.096
71078538|NCT01421147|141664990|SUPERIORITY_OR_OTHER||LS Mean Difference|1.267||||0.374|TWO_SIDED|95.0|-1.531|4.065||P-value is for Endpoint, up to 24 wk-Bolus Insulin.|ANCOVA|||||4.065|-1.531|0.374
71078539|NCT01421147|141664990|SUPERIORITY_OR_OTHER||LS Mean Difference|2.964||||0.151|TWO_SIDED|95.0|-1.081|7.01||P-value is for Endpoint, up to 24 wk-Total Insulin.|ANCOVA|||||7.010|-1.081|0.151
71078540|NCT01421147|141664990|SUPERIORITY_OR_OTHER||LS Mean Difference|2.059||||0.072|TWO_SIDED|95.0|-0.187|4.305||P-value is for Endpoint, up to 52 wk-Basal Insulin.|ANCOVA|||||4.305|-0.187|0.072
71078541|NCT01421147|141664990|SUPERIORITY_OR_OTHER||LS Mean Difference|0.702||||0.617|TWO_SIDED|95.0|-2.058|3.462||P-value is for Endpoint, up to 52 wk-Bolus Insulin.|ANCOVA|||||3.462|-2.058|0.617
71078542|NCT01421147|141664990|SUPERIORITY_OR_OTHER||LS Mean Difference|2.8||||0.188|TWO_SIDED|95.0|-1.37|6.971||P-value is for Endpoint, up to 52 wk-Total Insulin.|ANCOVA|||||6.971|-1.370|0.188
71078543|NCT01421147|141664991|SUPERIORITY_OR_OTHER|||||||0.015||||||P-value is for HbA1c- at Baseline \<7.0 %.|Fisher Exact|||||||0.015
71078544|NCT01421147|141664991|SUPERIORITY_OR_OTHER|||||||0.606||||||P-value is for HbA1c- at Baseline ≤6.5%.|Fisher Exact|||||||0.606
71078545|NCT01421147|141664991|SUPERIORITY_OR_OTHER|||||||0.012||||||P-value is for HbA1c- at 6 weeks \<7.0%.|Fisher Exact|||||||0.012
71078546|NCT01421147|141664991|SUPERIORITY_OR_OTHER|||||||0.053||||||P-value is for HbA1c- at 6 weeks ≤6.5%.|Fisher Exact|||||||0.053
71078547|NCT01421147|141664991|SUPERIORITY_OR_OTHER|||||||0.398||||||P-value is for HbA1c- at 12 weeks \<7.0%.|Fisher Exact|||||||0.398
71078548|NCT01421147|141664991|SUPERIORITY_OR_OTHER|||||||0.17||||||P-value is for HbA1c- at 12 weeks ≤6.5%.|Fisher Exact|||||||0.170
71078549|NCT01421147|141664991|SUPERIORITY_OR_OTHER|||||||0.926||||||P-value is for HbA1c- at 24 weeks \<7.0%.|Fisher Exact|||||||0.926
71078550|NCT01421147|141664991|SUPERIORITY_OR_OTHER|||||||0.824||||||P-value is for HbA1c- at 24 weeks ≤6.5%.|Fisher Exact|||||||0.824
71065062|NCT00463047|141639112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.0081|TWO_SIDED|95.0|0.01|0.05||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID5 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.05|0.01|0.0081
71065063|NCT00463047|141639113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|0.05|0.13||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID10 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.13|0.05|<0.0001
71065064|NCT00463047|141639114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|0.3|0.45||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID10 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.45|0.30|<0.0001
71065065|NCT00463047|141639115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|0.2|0.35||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID45 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.35|0.20|<0.0001
71065066|NCT00463047|141639116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|0.08|0.25||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID60 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.25|0.08|<0.0001
71065067|NCT00463047|141639123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001||95.0|0.39|0.58|||ANOVA|||||0.58|0.39|<0.0001
71065068|NCT00463047|141639124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.34|<|0.0001|TWO_SIDED|95.0|0.7|1.16|||ANOVA|||||1.16|0.70|<0.0001
71065069|NCT00463047|141639125|SUPERIORITY_OR_OTHER|||||||0.1966||95.0|||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.1966
71078551|NCT01421147|141664991|SUPERIORITY_OR_OTHER|||||||0.385||||||P-value is for HbA1c- at 36 weeks \<7.0%.|Fisher Exact|||||||0.385
71078552|NCT01421147|141664991|SUPERIORITY_OR_OTHER|||||||0.408||||||P-value is for HbA1c- at 36 weeks ≤6.5%.|Fisher Exact|||||||0.408
71078553|NCT01421147|141664991|SUPERIORITY_OR_OTHER|||||||0.551||||||P-value is for HbA1c- at 52 weeks \<7.0%.|Fisher Exact|||||||0.551
71078554|NCT01421147|141664991|SUPERIORITY_OR_OTHER|||||||0.9||||||P-value is for HbA1c- at 52 weeks ≤6.5%.|Fisher Exact|||||||0.900
71078555|NCT01421147|141664991|SUPERIORITY_OR_OTHER|||||||0.646||||||P-value is for HbA1c- Endpoint, up to 24 weeks \<7.0%.|Fisher Exact|||||||0.646
71078556|NCT01421147|141664991|SUPERIORITY_OR_OTHER|||||||0.661||||||P-value is for HbA1c- Endpoint, up to 24 weeks ≤6.5%.|Fisher Exact|||||||0.661
71078557|NCT01421147|141664991|SUPERIORITY_OR_OTHER|||||||0.209||||||P-value is for HbA1c- Endpoint, up to 52 weeks \<7.0%.|Fisher Exact|||||||0.209
71078558|NCT01421147|141664991|SUPERIORITY_OR_OTHER|||||||0.54||||||P-value is for HbA1c- Endpoint, up to 52 weeks ≤6.5%.|Fisher Exact|||||||0.540
71078559|NCT01421147|141664992|SUPERIORITY_OR_OTHER|||||||0.703||||||P-value is for Total Events with BG ≤70 mg/dL,if available-24 wk.|Fisher Exact|||||||0.703
71078560|NCT01421147|141664992|SUPERIORITY_OR_OTHER|||||||0.495||||||P-value is for Total Events with BG ≤70 mg/dL,if available-52-wk.|Fisher Exact|||||||0.495
71078561|NCT01421147|141664992|SUPERIORITY_OR_OTHER|||||||0.174||||||P-value is for Severe Events-24 wk.|Fisher Exact|||||||0.174
71078562|NCT01421147|141664992|SUPERIORITY_OR_OTHER|||||||0.828||||||P-value is for Severe Events-52 wk.|Fisher Exact|||||||0.828
71078563|NCT01421147|141664992|SUPERIORITY_OR_OTHER|||||||0.661||||||P-value is for Nocturnal Events with BG ≤70 mg/dL-24 wk.|Fisher Exact|||||||0.661
71078564|NCT01421147|141664992|SUPERIORITY_OR_OTHER|||||||0.606||||||P-value is for Nocturnal Events with BG ≤70 mg/dL-52 wk.|Fisher Exact|||||||0.606
71078565|NCT01421147|141664993|SUPERIORITY_OR_OTHER|||||||0.717||||||P-value is for Total Events with BG ≤70 mg/dL, if available-24 wk.|Wilcoxon (Mann-Whitney)|||||||0.717
71065070|NCT00463047|141639126|SUPERIORITY_OR_OTHER|||||||0.0275||95.0|||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0275
71065071|NCT00463047|141639127|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0001
71065072|NCT00463047|141639128|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||<0.0001
71065073|NCT00463047|141639129|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0004
71065074|NCT00463047|141639130|SUPERIORITY_OR_OTHER|||||||0.0074||95.0|||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0074
71065075|NCT00463047|141639131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001||95.0|0.55|0.83||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||||0.83|0.55|<0.0001
71065076|NCT00463047|141639133|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5054||||0.3022|TWO_SIDED|95.0|0.7|3.3|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||3.3|0.7|0.3022
71065077|NCT00463047|141639134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4042||||0.0268|TWO_SIDED|95.0|1.0|1.9|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.9|1.0|0.0268
71065078|NCT00463047|141639135|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4631||||0.0008|TWO_SIDED|95.0|1.2|1.8|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.8|1.2|0.0008
71065079|NCT00463047|141639136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3184||||0.0084|TWO_SIDED|95.0|1.1|1.6|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.6|1.1|0.0084
71065080|NCT00463047|141639137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0788||||0.5283|TWO_SIDED|95.0|0.9|1.4|||Generalize estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.4|0.9|0.5283
71065081|NCT00463047|141639138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9491||||0.711|TWO_SIDED|95.0|0.7|1.3|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.3|0.7|0.7110
71065082|NCT00463047|141639139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5355||||0.3288|TWO_SIDED|95.0|0.2|1.9|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.9|0.2|0.3288
71065083|NCT00463047|141639140|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1485||||0.5145|TWO_SIDED|95.0|0.8|1.7|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.7|0.8|0.5145
71065084|NCT00463047|141639141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4481||||0.0191|TWO_SIDED|95.0|1.1|2.0|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||2.0|1.1|0.0191
71065085|NCT00463047|141639142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4396||||0.0006|TWO_SIDED|95.0|1.2|1.8|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.8|1.2|0.0006
71065086|NCT00463047|141639143|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3426||||0.0044|TWO_SIDED|95.0|1.1|1.6|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.6|1.1|0.0044
71065087|NCT00463047|141639144|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1448||||0.2184|TWO_SIDED|95.0|0.9|1.4|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.4|0.9|0.2184
71065088|NCT00463047|141639145|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9249||||0.5808|TWO_SIDED|95.0|0.7|1.2|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.2|0.7|0.5808
71065089|NCT00463047|141639146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8908|||<|0.0001|TWO_SIDED|95.0|1.7|2.2|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A cumulative logit link function and independent working correlation were applied in this model. Treatment differences for each time point were measured across all categories of responses.||2.2|1.7|<0.0001
71078566|NCT01421147|141664993|SUPERIORITY_OR_OTHER|||||||0.163||||||P-value is for Severe Events-24 wk.|Wilcoxon (Mann-Whitney)|||||||0.163
71078567|NCT01421147|141664993|SUPERIORITY_OR_OTHER|||||||0.669||||||P-value is for Nocturnal Events with BG ≤70 mg/dL-24 wk.|Wilcoxon (Mann-Whitney)|||||||0.669
71065090|NCT00463047|141639147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5841|||<|0.0001|TWO_SIDED|95.0|1.4|1.8|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A cumulative logit link function and independent working correlation were applied in this model. Treatment differences for each time point were measured across all categories of responses.||1.8|1.4|<0.0001
71065091|NCT03020992|141639173|OTHER||Rate ratio|0.18|||<|0.001|TWO_SIDED|95.0|0.116|0.281|||Poisson regression|||"The Poisson regression allowed for a comparison of event rates adjusting for differences in time between prestudy/on-study periods.~Event rates were based on a Poisson model with generalized estimating equations and a log-link, including an offset term for time interval length, and with period and disease duration of axSpA (\<2 years/≥2 years) as covariates. A repeated statement was included for participants and assumed an exchangeable correlation structure between prestudy and on-study flares."||0.281|0.116|<0.001
71065092|NCT01006122|141639205|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.747||0.418|TWO_SIDED|80.0|-0.81|1.12|||Mixed Models Analysis|||One sided p-value was based on linear mixed effects model with treatment and period as fixed effects, baseline MWT as a covariate and participant as random effect.||1.12|-0.81|0.418
71065093|NCT01006122|141639206|SUPERIORITY_OR_OTHER||LS Means Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.457||0.054|TWO_SIDED|80.0|-1.32|-0.15|||Mixed Models Analysis|||Day 5 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||-0.15|-1.32|0.054
71065094|NCT01006122|141639206|SUPERIORITY_OR_OTHER||LS Means Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.453||0.247|TWO_SIDED|80.0|-0.89|0.27|||Mixed Models Analysis|||Day 10 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||0.27|-0.89|0.247
71065095|NCT01006122|141639206|SUPERIORITY_OR_OTHER||LS Means Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.457||0.095|TWO_SIDED|80.0|-1.19|-0.01|||Mixed Models Analysis|||Day 15 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||-0.01|-1.19|0.095
71065096|NCT01006122|141639206|SUPERIORITY_OR_OTHER||LS Means Difference|0.13|STANDARD_ERROR_OF_MEAN|0.487||0.604|TWO_SIDED|80.0|-0.5|0.75|||Mixed Models Analysis|||Day 20 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||0.75|-0.50|0.604
71065097|NCT01006122|141639206|SUPERIORITY_OR_OTHER||LS Means Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.473||0.232|TWO_SIDED|80.0|-0.95|0.26|||Mixed Models Analysis|||Day 7 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||0.26|-0.95|0.232
71065098|NCT01006122|141639206|SUPERIORITY_OR_OTHER||LS Means Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.473||0.093|TWO_SIDED|80.0|-1.23|-0.02|||Mixed Models Analysis|||Day 14 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||-0.02|-1.23|0.093
71065099|NCT01006122|141639206|SUPERIORITY_OR_OTHER||LS Means Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.498||0.274|TWO_SIDED|80.0|-0.94|0.34|||Mixed Models Analysis|||Day 21 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||0.34|-0.94|0.274
71065100|NCT01006122|141639207|SUPERIORITY_OR_OTHER||LS Means Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.244||0.121|TWO_SIDED|80.0|-0.6|0.03|||Mixed Models Analysis|||Day 5 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||0.03|-0.60|0.121
71065101|NCT01006122|141639207|SUPERIORITY_OR_OTHER||LS Means Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.243||0.394|TWO_SIDED|80.0|-0.38|0.25|||Mixed Models Analysis|||Day 10 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||0.25|-0.38|0.394
71065102|NCT01006122|141639207|SUPERIORITY_OR_OTHER||LS Means Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.244||0.073|TWO_SIDED|80.0|-0.67|-0.04|||Mixed Models Analysis|||Day 15 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||-0.04|-0.67|0.073
71065103|NCT01006122|141639207|SUPERIORITY_OR_OTHER||LS Means Difference|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.495|TWO_SIDED|80.0|-0.34|0.33|||Mixed Models Analysis|||Day 20 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||0.33|-0.34|0.495
71078568|NCT01421147|141664993|SUPERIORITY_OR_OTHER|||||||0.738||||||P-value is for Total Events with BG ≤70 mg/dL, if available-52 wk.|Wilcoxon (Mann-Whitney)|||||||0.738
70941765|NCT04748445|141383935|OTHER||Slope|0.000649|STANDARD_ERROR_OF_MEAN|4.448||0.1471|TWO_SIDED|90.0|-0.0000881|0.001386|||Mixed Models Analysis|||READ\_MFCC 1st order delta 02 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001386|-0.0000881|0.1471
71078569|NCT01421147|141664993|SUPERIORITY_OR_OTHER|||||||0.826||||||P-value is for Severe Events-52 wk.|Wilcoxon (Mann-Whitney)|||||||0.826
71111286|NCT02297815|141729067|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.2|||<|0.001|TWO_SIDED|95.0|7.3|17.2|||Weighted logistic regression|Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.|Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.||17.2|7.3|<0.001
71111287|NCT02297815|141729068|SUPERIORITY_OR_OTHER||Risk Difference (RD)|4.9||||0.09|TWO_SIDED|95.0|-0.8|10.6|||Weighted logistic regression|Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.|Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.||10.6|-0.8|0.09
71111288|NCT02297815|141729069|SUPERIORITY||Risk Difference (RD)|4.6||||0.07|TWO_SIDED|95.0|-0.3|9.6|||Weighted logistic regression|Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.|Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.||9.6|-0.3|0.07
71111289|NCT02197572|141729079|OTHER||Least Squares Mean|-2.2|||||ONE_SIDED|95.0||2.2||||||Change from Baseline at 0.25 Hours Postdose||2.2||
71111290|NCT02197572|141729079|OTHER||Least Squares Mean|-8.3|||||ONE_SIDED|95.0||-4.0||||||Change from Baseline at 0.5 Hours Postdose||-4.0||
71111291|NCT02197572|141729079|OTHER||Least Squares Mean|-1.8|||||ONE_SIDED|95.0||2.6||||||Change from Baseline at 1 Hour Postdose||2.6||
71111292|NCT02197572|141729079|OTHER||Least Squares Mean|-2.7|||||ONE_SIDED|95.0||1.7||||||Change from Baseline at 1.5 Hours Postdose||1.7||
71111293|NCT02197572|141729079|OTHER||Least Squares Mean|-5.0|||||ONE_SIDED|95.0||-0.6||||||Change from Baseline at 2 Hours Postdose||-0.6||
71111294|NCT02197572|141729079|OTHER||Least Squares Mean|-7.6|||||ONE_SIDED|95.0||-3.2||||||Change from Baseline at 2.5 Hours Postdose||-3.2||
71111295|NCT02197572|141729079|OTHER||Least Squares Mean|-9.1|||||ONE_SIDED|95.0||-4.6||||||Change from Baseline at 3 Hours Postdose||-4.6||
71111296|NCT02197572|141729079|OTHER||Least Squares Mean|-7.2|||||ONE_SIDED|95.0||-2.9||||||Change from Baseline at 4 Hours Postdose||-2.9||
71111297|NCT02197572|141729079|OTHER||Least Squares Mean|-8.8|||||ONE_SIDED|95.0||-4.6||||||Change from Baseline at 6 Hours Postdose||-4.6||
71111298|NCT02197572|141729079|OTHER||Least Squares Mean|-2.2|||||ONE_SIDED|95.0||2.4||||||Change from Baseline at 8 Hours Postdose||2.4||
71111299|NCT02197572|141729079|OTHER||Least Squares Mean|-6.6|||||ONE_SIDED|95.0||-0.5||||||Change from Baseline at 10 Hours Postdose||-0.5||
70938097|NCT02291861|141376212|SUPERIORITY||Odds Ratio (OR)|2.11||||0.059|TWO_SIDED|95.0|0.96|4.645|||Cochran-Mantel-Haenszel|The statistical test was a Cochran-Mantel-Haenszel (CMH) test stratified by baseline use of dopamine receptor antagonist (DRAs).|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~This key secondary endpoint compared the percentage of patients considered a treatment success at week 12 between the SD-809 36 mg/day group and the placebo group, and is the second analysis in the fixed-sequence."||4.645|0.960|0.059
71111300|NCT02197572|141729079|OTHER||Least Squares Mean|7.1|||||ONE_SIDED|95.0||11.4||||||Change from Baseline at 24 Hours Postdose||11.4||
71111301|NCT02197572|141729079|OTHER||Least Squares Mean|2.8|||||ONE_SIDED|95.0||8.1||||||Change from Baseline at 48 Hours Postdose||8.1||
71111302|NCT00473889|141729095|SUPERIORITY_OR_OTHER|||||||0.992||95.0||||This is a one sided p-value, which corresponds to the null hypothesis.|Stratified Log Rank|Disease stage and bevacizumab eligibility are the stratification factors in the stratified log rank test.||||||0.992
71111303|NCT00473889|141729096|SUPERIORITY_OR_OTHER|||||||0.862||95.0||||This is a one sided p-value, which corresponds to the null hypothesis.|Finkelstein's Interval Censored Method|Disease stage and bevacizumab eligibility are the stratification factors in the Finkelstein's Interval Censored Method Model.||||||0.862
71111304|NCT00473889|141729097|SUPERIORITY_OR_OTHER|||||||0.899||95.0||||This is a one sided p-value, which corresponds to the null hypothesis.|Stratified Miettinen and Nurminen|Disease stage and bevacizumab eligibility are the stratification factors in the stratified Miettinen and Nurmimen method.||||||0.899
71111305|NCT03783962|141729098|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|||||||.003
71111306|NCT03783962|141729099|SUPERIORITY|||||||0.97|||||||Mixed Models Analysis|||||||.97
71111307|NCT03783962|141729100|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||.08
71111308|NCT03783962|141729100|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
71111309|NCT03783962|141729100|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
71111310|NCT03783962|141729101|SUPERIORITY|||||||0.18|||||||Mixed Models Analysis|||||||.18
71111311|NCT03783962|141729101|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||||||.40
71111312|NCT03783962|141729101|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||.01
71111313|NCT03783962|141729102|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||||||.40
71111314|NCT03783962|141729102|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
71111315|NCT03783962|141729102|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
71111316|NCT03783962|141729103|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||.25
71111317|NCT03783962|141729103|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
71111318|NCT03783962|141729103|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
71111319|NCT03783962|141729104|SUPERIORITY|||||||0.26|||||||Mixed Models Analysis|||||||.26
71111320|NCT03783962|141729104|SUPERIORITY|||||||0.41|||||||Mixed Models Analysis|||||||.41
71111321|NCT03783962|141729104|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||||||.02
71111322|NCT03783962|141729105|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||.03
71111323|NCT03783962|141729105|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||||||.02
71111324|NCT03783962|141729105|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
70938098|NCT02291861|141376212|SUPERIORITY||Odds Ratio (OR)|2.71||||0.014|TWO_SIDED|95.0|1.211|6.052|||Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~This key secondary endpoint compared the percentage of patients considered a treatment success at week 12 between the SD-809 24 mg/day group and the placebo group, and is the fourth analysis in the fixed-sequence."||6.052|1.211|0.014
71111325|NCT03783962|141729106|SUPERIORITY|||||||0.58|||||||Mixed Models Analysis|||||||.58
71111326|NCT03783962|141729106|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||.05
71111327|NCT03783962|141729106|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||.01
71111328|NCT03783962|141729107|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||.009
71111329|NCT03783962|141729108|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
71111330|NCT03458325|141729109|SUPERIORITY||Mean Difference (Final Values)|-16.0|||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||"The comparator arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF. The filter was further strengthened by analyzing diagnostic codes and resource utilization during their hospital stay to exclude hospitalizations other than Heart Failure.~Each subject from the Furoscix group was matched to controls in ratios ranging from 1:1 to 4:1."||-11,802.70|-22,187.90|<0.0001
71111331|NCT03458325|141729110|SUPERIORITY||Percentage Difference|-6.4||||0.6765|TWO_SIDED||||||Fisher Exact|||"The comparator arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF. The filter was further strengthened by analyzing diagnostic codes and resource utilization during their hospital stay to exclude hospitalizations other than Heart Failure.~Each subject from the Furoscix group was matched to controls in ratios ranging from 1:1 to 4:1."||||0.6765
71111332|NCT03458325|141729111|SUPERIORITY||Mean Difference (Net)|5.3||||0.5856|TWO_SIDED||||||Fisher Exact|||"The comparator arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF. The filter was further strengthened by analyzing diagnostic codes and resource utilization during their hospital stay to exclude hospitalizations other than Heart Failure.~Each subject from the Furoscix group was matched to controls in ratios ranging from 1:1 to 4:1."||||0.5856
71111333|NCT03458325|141729112|SUPERIORITY||Mean Difference (Net)|-1.9||||1|TWO_SIDED||||||Fisher Exact|||"The comparator arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF. The filter was further strengthened by analyzing diagnostic codes and resource utilization during their hospital stay to exclude hospitalizations other than Heart Failure.~Each subject from the Furoscix group was matched to controls in ratios ranging from 1:1 to 4:1."||||1.000
71111334|NCT03458325|141729113|SUPERIORITY||Mean Difference (Net)|65.1|||<|0.0001|TWO_SIDED||||||Chi-squared|||"The comparator arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF. The filter was further strengthened by analyzing diagnostic codes and resource utilization during their hospital stay to exclude hospitalizations other than Heart Failure.~Each subject from the Furoscix group was matched to controls in ratios ranging from 1:1 to 4:1."||||<0.0001
71111335|NCT03458325|141729114|SUPERIORITY||Mean Difference (Net)|12.8||||0.0443|TWO_SIDED|95.0|0.4|25.3|||t-test, 2 sided|P-value was obtained from the paired t-test statistic.||Analysis for Summary Score||25.3|0.4|0.0443
71111336|NCT03458325|141729115|SUPERIORITY|Statistical Analysis for the mean change in NT-proBNP over 30 days|Mean Difference (Final Values)|-122.6||||0.5133|TWO_SIDED|95.0|-525.8|280.5|||t-test, 2 sided|||||280.5|-525.8|0.5133
71111337|NCT03458325|141729115|SUPERIORITY||Mean Difference (Final Values)|-719.9||||0.042|TWO_SIDED|95.0|-1406.5|-33.2|||t-test, 2 sided|||Statistical Analysis for mean change in BNP over 30 days||-33.2|-1406.5|0.0420
71111338|NCT02956746|141729119|OTHER|||||||0.4187||||||threshold for significance p-values \< 0.05|ANOVA|||||||0.4187
71111339|NCT02621476|141729140|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71065104|NCT01006122|141639207|SUPERIORITY_OR_OTHER||LS Means Difference|0.14|STANDARD_ERROR_OF_MEAN|0.253||0.711|TWO_SIDED|80.0|-0.18|0.46|||Mixed Models Analysis|||Day 7 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||0.46|-0.18|0.711
71065105|NCT01006122|141639207|SUPERIORITY_OR_OTHER||LS Means Difference|0.18|STANDARD_ERROR_OF_MEAN|0.253||0.767|TWO_SIDED|80.0|-0.14|0.51|||Mixed Models Analysis|||Day 14 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||0.51|-0.14|0.767
71065106|NCT01006122|141639207|SUPERIORITY_OR_OTHER||LS Means Difference|0.14|STANDARD_ERROR_OF_MEAN|0.266||0.698|TWO_SIDED|80.0|-0.2|0.48|||Mixed Models Analysis|||Day 21 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||0.48|-0.20|0.698
71065107|NCT01006122|141639210|SUPERIORITY_OR_OTHER||LS Means Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.142||0.127|TWO_SIDED|80.0|-0.34|0.02|||Mixed Models Analysis|||Day 5 (TP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.02|-0.34|0.127
71065108|NCT01006122|141639210|SUPERIORITY_OR_OTHER||LS Means Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.141||0.303|TWO_SIDED|80.0|-0.25|0.11|||Mixed Models Analysis|||Day 10 (TP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.11|-0.25|0.303
71065109|NCT01006122|141639210|SUPERIORITY_OR_OTHER||LS Means Difference|0.09|STANDARD_ERROR_OF_MEAN|0.143||0.738|TWO_SIDED|80.0|-0.09|0.27|||Mixed Models Analysis|||Day 15 (TP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.27|-0.09|0.738
71065110|NCT01006122|141639210|SUPERIORITY_OR_OTHER||LS Means Difference|0.16|STANDARD_ERROR_OF_MEAN|0.152||0.85|TWO_SIDED|80.0|-0.04|0.35|||Mixed Models Analysis|||Day 20 (TP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.35|-0.04|0.850
70941766|NCT04748445|141383935|OTHER||Slope|1.355|STANDARD_ERROR_OF_MEAN|3.323||0.6842|TWO_SIDED|90.0|-4.152|6.862|||Mixed Models Analysis|||READ\_MFCC 1st order delta 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||6.862|-4.152|0.6842
71065111|NCT01006122|141639210|SUPERIORITY_OR_OTHER||LS Means Difference|0.05|STANDARD_ERROR_OF_MEAN|0.148||0.631|TWO_SIDED|80.0|-0.14|0.24|||Mixed Models Analysis|||Day 7 (SP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.24|-0.14|0.631
71065112|NCT01006122|141639210|SUPERIORITY_OR_OTHER||LS Means Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.147||0.16|TWO_SIDED|80.0|-0.34|0.04|||Mixed Models Analysis|||Day 14 (SP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.04|-0.34|0.160
71065113|NCT01006122|141639210|SUPERIORITY_OR_OTHER||LS Means Difference|0.02|STANDARD_ERROR_OF_MEAN|0.156||0.541|TWO_SIDED|80.0|-0.18|0.22|||Mixed Models Analysis|||Day 21 (SP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.22|-0.18|0.541
71065114|NCT02560922|141639222|SUPERIORITY||Mean Difference (Final Values)|-0.63||||0.128|TWO_SIDED|95.0|-1.45|0.18|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||0.18|-1.45|0.128
71065115|NCT02560922|141639222|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.068|TWO_SIDED|95.0|-1.73|0.06|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||0.06|-1.73|0.068
71065116|NCT02560922|141639223|SUPERIORITY||Mean Difference (Final Values)|-2.62||||0.129|TWO_SIDED|95.0|-6.01|0.77|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||0.77|-6.01|0.129
71065117|NCT02560922|141639223|SUPERIORITY||Mean Difference (Final Values)|-3.31||||0.084|TWO_SIDED|95.0|-7.07|0.44|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||0.44|-7.07|0.084
71065118|NCT02560922|141639224|SUPERIORITY||Mean Difference (Final Values)|-1.61||||0.209|TWO_SIDED|95.0|-4.14|0.91|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||0.91|-4.14|0.209
71065119|NCT02560922|141639224|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.128|TWO_SIDED|95.0|-5.03|0.63|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||0.63|-5.03|0.128
71065120|NCT02560922|141639225|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.222|TWO_SIDED|95.0|-2.18|0.51|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||0.51|-2.18|0.222
71065121|NCT02560922|141639225|SUPERIORITY||Mean Difference (Final Values)|-1.14||||0.128|TWO_SIDED|95.0|-2.6|0.33|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||0.33|-2.60|0.128
71065122|NCT02560922|141639226|SUPERIORITY||Mean Difference (Final Values)|1.71||||0.111|TWO_SIDED|95.0|-0.4|3.82|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||3.82|-0.40|0.111
71065123|NCT02560922|141639226|SUPERIORITY||Mean Difference (Final Values)|0.73||||0.502|TWO_SIDED|95.0|-1.42|2.88|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||2.88|-1.42|0.502
71065124|NCT02560922|141639227|SUPERIORITY||Mean Difference (Final Values)|0.76||||0.433|TWO_SIDED|95.0|-1.15|2.66|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||2.66|-1.15|0.433
71078570|NCT01421147|141664993|SUPERIORITY_OR_OTHER|||||||0.25||||||P-value is for Nocturnal Events with BG ≤70 mg/dL-52 wk.|Wilcoxon (Mann-Whitney)|||||||0.250
71078571|NCT00904917|141665028|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||t-test, 2 sided|||||||.015
71078572|NCT00904917|141665030|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||Regression, Linear|||||||.037
71078573|NCT05206734|141665033|OTHER||Hazard Ratio (HR)|1.28|||||TWO_SIDED|95.0|1.12|1.46|||||HR was calculated using a Cox Proportional Hazard model adjusted for age,sex,socioeconomic status, ethnicity and common childhood conditions. Reflects a comparison of the incidence rates between participants diagnosed with IBD and those without IBD.|||1.46|1.12|
70938099|NCT02291861|141376212|SUPERIORITY||Odds Ratio (OR)|1.15||||0.734|TWO_SIDED|95.0|0.509|2.61|||Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~This key secondary endpoint compared the percentage of patients considered a treatment success at week 12 between the SD-809 12 mg/day group and the placebo group, and is the sixth (last) analysis in the fixed-sequence."||2.610|0.509|0.734
70938100|NCT02291861|141376213|SUPERIORITY||LSM difference|-3.6||||0.207|TWO_SIDED|95.0|-9.18|2.0||5% level of significance (2-sided)|ANCOVA|The statistical model was an ANCOVA with treatment group and baseline use of DRAs as fixed effects and the baseline value as a covariate.|SD-809 - placebo|||2.00|-9.18|0.207
71065125|NCT02560922|141639227|SUPERIORITY||Mean Difference (Final Values)|1.71||||0.12|TWO_SIDED|95.0|-0.45|3.86|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||3.86|-0.45|0.120
71065126|NCT02560922|141639228|SUPERIORITY||Mean Difference (Final Values)|15.31||||0.001|TWO_SIDED|95.0|9.09|21.53|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||21.53|9.09|0.001
71065127|NCT02560922|141639228|SUPERIORITY||Mean Difference (Final Values)|11.67|||<|0.001|TWO_SIDED|95.0|5.08|18.27|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||18.27|5.08|<0.001
71065128|NCT02560922|141639229|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.356|TWO_SIDED|95.0|-1.57|0.57|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||0.57|-1.57|0.356
71065129|NCT02560922|141639229|SUPERIORITY||Mean Difference (Final Values)|-1.02||||0.087|TWO_SIDED|95.0|-2.19|0.15|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||0.15|-2.19|0.087
71065130|NCT02560922|141639230|SUPERIORITY||Mean Difference (Final Values)|1.01|||<|0.001|TWO_SIDED|95.0|0.61|1.41|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||1.41|0.61|<0.001
71065131|NCT02560922|141639230|SUPERIORITY||Mean Difference (Final Values)|0.67||||0.002|TWO_SIDED|95.0|0.24|1.09|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||1.09|0.24|0.002
70938101|NCT02291861|141376213|SUPERIORITY||LSM difference|-3.1||||0.281|TWO_SIDED|95.0|-8.86|2.59||5% level of significance (2-sided)|ANCOVA|The statistical model was an ANCOVA with treatment group and baseline use of DRAs as fixed effects and the baseline value as a covariate.|SD-809 - placebo|||2.59|-8.86|0.281
70938102|NCT02291861|141376213|SUPERIORITY||LSM difference|1.3||||0.627|TWO_SIDED|95.0|-4.1|6.79||5% level of significance (2-sided)|ANCOVA|The statistical model was an ANCOVA with treatment group and baseline use of DRAs as fixed effects and the baseline value as a covariate.|SD-809 - placebo|||6.79|-4.10|0.627
71065132|NCT02560922|141639231|SUPERIORITY||Mean Difference (Final Values)|-1.27|||<|0.001|TWO_SIDED|95.0|-1.6|-0.95|||Mixed Models Analysis|||Test of between-group difference in self-reported change in symptoms (from baseline) at 3 months||-0.95|-1.60|<0.001
71065133|NCT02560922|141639231|SUPERIORITY||Mean Difference (Final Values)|-0.87|||<|0.001|TWO_SIDED|95.0|-1.24|-0.51|||Mixed Models Analysis|||Test of between-group difference in self-reported change in symptoms (from baseline) at 9 months||-0.51|-1.24|<0.001
71065134|NCT03926117|141639243|SUPERIORITY||Median Difference (Final Values)|-66.2|||<|0.0001|TWO_SIDED|95.0|-86.15|-49.12|||Hodges-Lehmann method|||Percent change from baseline is analyzed using nonparametric Hodges-Lehmann estimator. The nonparametric analysis accounts for covariates baseline hemoglobin (greater than or equal to (\>=) 11 or less than (\<) 11 grams per deciliter (g/dL)) and chronic kidney disease stage (3, 4 or 5) by aligning responses within each stratum defined by the covariates prior to analysis.||-49.12|-86.15|<0.0001
71065135|NCT03926117|141639243|SUPERIORITY||Median Difference (Final Values)|-77.71|||<|0.0001|TWO_SIDED|95.0|-94.98|-62.97|||Hodges-Lehmann method|||Percent change from baseline is analyzed using nonparametric Hodges-Lehmann estimator. The nonparametric analysis accounts for covariates baseline hemoglobin (\>= 11 or \< 11 g/dL) and chronic kidney disease stage (3, 4 or 5) by aligning responses within each stratum defined by the covariates prior to analysis.||-62.97|-94.98|<0.0001
71065136|NCT03926117|141639243|SUPERIORITY||Median Difference (Final Values)|-87.76|||<|0.0001|TWO_SIDED|95.0|-101.0|-70.54|||Hodges-Lehmann method|||Percent change from baseline is analyzed using nonparametric Hodges-Lehmann estimator. The nonparametric analysis accounts for covariates baseline hemoglobin (\>= 11 or \< 11 g/dL) and chronic kidney disease stage (3, 4 or 5) by aligning responses within each stratum defined by the covariates prior to analysis.||-70.54|-101.00|<0.0001
71065137|NCT02554682|141639261|SUPERIORITY|||||||0.906|||||||Generalized Linear Model|||||||.906
71065138|NCT02554682|141639261|SUPERIORITY|||||||0.796|||||||Generalized Linear Model|||||||.796
71065139|NCT02554682|141639261|SUPERIORITY|||||||0.886|||||||Generalized Linear Model|||||||.886
71065140|NCT02554682|141639261|OTHER|||||||0.082|||||||Generalized Linear Model|||||||.082
71065141|NCT02554682|141639262|SUPERIORITY|||||||0.677|||||||Generalized Linear Model|||||||0.677
71065142|NCT02554682|141639262|SUPERIORITY|||||||0.02|||||||Generalized Linear Model|||||||0.020
71065143|NCT02554682|141639262|SUPERIORITY|||||||0.952|||||||Generalized Linear Model|||||||.952
71065144|NCT02554682|141639262|SUPERIORITY|||||||0.21|||||||Generalized Linear Model|||||||0.210
71065145|NCT02554682|141639263|SUPERIORITY|||||||0.505|||||||Generalized Linear Model|||||||0.505
71065146|NCT02554682|141639263|SUPERIORITY|||||||0.176|||||||Generalized Linear Model|||||||.176
71065147|NCT02554682|141639263|SUPERIORITY|||||||0.134|||||||Generalized Linear Model|||||||0.134
71065148|NCT02554682|141639263|SUPERIORITY|||||||0.029|||||||Generalized Linear Model|||||||0.029
71065149|NCT02554682|141639264|SUPERIORITY|||||||0.037|||||||t-test, 2 sided|||||||.037
71065150|NCT02554682|141639265|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||.003
71065151|NCT02554682|141639266|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
71065152|NCT02554682|141639267|SUPERIORITY|||||||0.571|||||||t-test, 2 sided|||||||.571
71065153|NCT02554682|141639268|SUPERIORITY|||||||0.394|||||||t-test, 2 sided|||||||.394
71065154|NCT02554682|141639269|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||.008
71065155|NCT02554682|141639270|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
71065156|NCT02554682|141639271|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||.001
71065157|NCT02554682|141639272|SUPERIORITY|||||||0.159|||||||t-test, 2 sided|||||||.159
71065158|NCT02554682|141639273|SUPERIORITY|||||||0.112|||||||t-test, 2 sided|||||||.112
71065159|NCT02554682|141639274|SUPERIORITY|||||||0.165|||||||t-test, 2 sided|||||||.165
71065160|NCT02554682|141639275|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||.006
71065161|NCT00086138|141639282|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.98|TWO_SIDED|95.0|0.52|1.97|||Chi-squared|||The statistical analyses compared data collected from the CGIC of participants who received sertraline who had a score equal to or better than the CGIC of participants who received the placebo intervention.||1.97|0.52|0.98
71065162|NCT00086138|141639283|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06||||0.11|TWO_SIDED|95.0|0.84|5.04|||Chi-squared|||||5.04|0.84|0.11
71065163|NCT00708461|141639319|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.125|STANDARD_ERROR_OF_MEAN|0.1202||0.36|TWO_SIDED|95.0|-0.21|0.46||Adjusted for age, educational attainment, race/ethnicity, and smoking status as individual, fixed-effect covariates. 95% confidence intervals and p-values derived from t-statistics with 4 degrees of freedom, reflecting the group-randomized design.|ANCOVA|Adjusted for age, educational attainment, race/ethnicity, and smoking status as individual, fixed-effect covariates.||"The null hypothesis was no effect of the environmental intervention. The following power assumptions were made:~* Intraclass correlation (ICC) of 0.016, estimated from an earlier study~* Variance of 118 kg, estimated from an earlier study~* Cohort N=400~* 15% attrition (by turnover) Using the external control and a worksite correlation of 0.2 gives a detectable difference of about 1.5 kg or 3 lb, or an effect size of 0.14. The effect size using internal control is 0.20."||0.46|-0.21|0.36
71065164|NCT00953654|141639357|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|The degrees of freedom were adjusted when the sphericity assumption was violated based on Mauchly's test.||Effects of RET and AET were compared to WL using a 3 condition by 3 time ANCOVA. An a priori statistical power analysis showed that a sample of 30 patients would provide a statistical power of .80 to detect a condition-by-time interaction for PSWQ scores assuming a two-tailed alpha value of 0.05, a correlation across repeated measures of 0.75 and a desire to detect a standardized effect size of 0.65.||||<0.05
71065165|NCT03517540|141639366|SUPERIORITY||Odds Ratio (OR)|0.8||||0.688|TWO_SIDED|95.0|0.25|2.63|||Cochran-Mantel-Haenszel|||||2.63|0.25|0.688
71065166|NCT03517540|141639366|SUPERIORITY||Odds Ratio (OR)|1.01||||0.985|TWO_SIDED|95.0|0.51|1.99|||Cochran-Mantel-Haenszel|||||1.99|0.51|0.985
71065167|NCT03517540|141639366|SUPERIORITY||Odds Ratio (OR)|0.92||||0.87|TWO_SIDED|95.0|0.3|2.84|||Cochran-Mantel-Haenszel|||||2.84|0.3|0.870
71065168|NCT03517540|141639366|SUPERIORITY||Odds Ratio (OR)|1.21||||0.71|TWO_SIDED|95.0|0.41|3.61|||Cochran-Mantel-Haenszel|||||3.61|0.41|0.710
71065169|NCT03517540|141639367|SUPERIORITY||Odds Ratio (OR)|0.37||||0.136|TWO_SIDED|95.0|0.08|1.61|||Cochran-Mantel-Haenszel|||||1.61|0.08|0.136
71065170|NCT03517540|141639367|SUPERIORITY||Odds Ratio (OR)|0.83||||0.747|TWO_SIDED|95.0|0.24|2.9|||Cochran-Mantel-Haenszel|||||2.9|0.24|0.747
71065171|NCT03517540|141639367|SUPERIORITY||Odds Ratio (OR)|0.84||||0.784|TWO_SIDED|95.0|0.18|3.63|||Cochran-Mantel-Haenszel|||||3.63|0.18|0.784
71065172|NCT03517540|141639367|SUPERIORITY||Odds Ratio (OR)|1.45||||0.521|TWO_SIDED|95.0|0.4|5.69|||Cochran-Mantel-Haenszel|||||5.69|0.4|0.521
71065173|NCT04850989|141639419|SUPERIORITY||Mean Difference (Net)|-5.14|STANDARD_DEVIATION|0.49|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||< 0.05
71065174|NCT04850989|141639420|SUPERIORITY||Mean Difference (Net)|-11.54|STANDARD_DEVIATION|-1.23|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||< 0.05
71065175|NCT04850989|141639421|SUPERIORITY||Mean Difference (Net)|-8.08|STANDARD_DEVIATION|1.91|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||< 0.05
70938103|NCT02291861|141376214|SUPERIORITY||Odds Ratio (OR)|1.51||||0.296|TWO_SIDED|95.0|0.694|3.285||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|||3.285|0.694|0.296
71065176|NCT04850989|141639422|SUPERIORITY||Mean Difference (Net)|-8.08|STANDARD_DEVIATION|1.91|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||< 0.05
71065177|NCT04850989|141639423|SUPERIORITY||Mean Difference (Net)|-3.48|STANDARD_DEVIATION|0.28|>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||> 0.05
71065178|NCT03055338|141639431|SUPERIORITY||Difference in LSM|2.6||||0.44|TWO_SIDED|95.0|-4.0|9.2|||Longitudinal ANCOVA|Includes terms for treatment, baseline PANSS total score, age, duration of illness, week, and the interaction of week by treatment.|Difference in LSM = MK-8189 - Risperidone|||9.2|-4.0|0.440
71065179|NCT03055338|141639431|SUPERIORITY||Difference in LSM|-4.7||||0.074|TWO_SIDED|95.0|-9.8|0.5|||Longitudinal ANCOVA|Includes terms for treatment, baseline PANSS total score, age, duration of illness, week, and the interaction of week by treatment.|Difference in LSM = MK-8189 - Placebo|||0.5|-9.8|0.074
71065180|NCT03055338|141639431|SUPERIORITY||Difference in LSM|-7.3||||0.033|TWO_SIDED|95.0|-14.0|-0.6|||Longitudinal ANCOVA|Includes terms for treatment, baseline PANSS total score, age, duration of illness, week, and the interaction of week by treatment.|Difference in LSM = Risperidone - Placebo|||-0.6|-14.0|0.033
71065181|NCT03055338|141639432|OTHER||Difference in % versus Placebo|17.2|||||TWO_SIDED|95.0|3.0|30.8|||||Difference in % = MK-8918 - Placebo||Based on Miettinen \& Nurminen method.|30.8|3.0|
71065182|NCT03055338|141639433|OTHER||Difference in % versus Placebo|-1.2|||||TWO_SIDED|95.0|-9.6|7.0|||||Difference in % = MK-8918 - Placebo||Based on Miettinen \& Nurminen method.|7.0|-9.6|
71065183|NCT03055338|141639434|OTHER||Difference in LSM|0.2|||||TWO_SIDED|95.0|-0.2|0.6|||||Difference in LSM = MK-8189 - Risperidone|||0.6|-0.2|
71065184|NCT03055338|141639434|OTHER||Difference in LSM|-0.2|||||TWO_SIDED|95.0|-0.5|0.2|||||Difference in LSM = MK-8189 - Placebo|||0.2|-0.5|
71065185|NCT03055338|141639434|OTHER||Difference in LSM|-0.4|||||TWO_SIDED|95.0|-0.8|0.1|||||Difference in LSM = Risperidone - Placebo|||0.1|-0.8|
71065186|NCT02151851|141639439|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.899|||<|0.001|TWO_SIDED|95.0|2.382|6.382||Difference of CZP + MTX versus Placebo + MTX (and corresponding p-value) was estimated from a logistic regression model with factors for treatment and region.|Regression, Logistic|||||6.382|2.382|<0.001
71065187|NCT02151851|141639440|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.641|||<|0.001|TWO_SIDED|95.0|3.57|16.352||Difference of CZP + MTX versus Placebo + MTX (and corresponding p-value) was estimated from a logistic regression model with factors for treatment and region.|Regression, Logistic|||||16.352|3.570|<0.001
71111340|NCT00131352|141729184|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||ANCOVA|The repeated measures ANCOVA model included terms for treatment, site, time and time-by-treatment interaction; the baseline score was a covariate.||||||0.047
71111341|NCT00131352|141729185|SUPERIORITY_OR_OTHER|||||||0.064||95.0|||||ANCOVA|||||||0.064
70938104|NCT02291861|141376214|SUPERIORITY||Odds Ratio (OR)|1.82||||0.134|TWO_SIDED|95.0|0.826|3.994||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|||3.994|0.826|0.134
71065188|NCT02151851|141639441|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.248|||<|0.001|TWO_SIDED|95.0|2.209|23.786||Difference of CZP + MTX versus Placebo + MTX (and corresponding p-value) was estimated from a logistic regression model with factors for treatment and region.|Regression, Logistic|||||23.786|2.209|<0.001
71065189|NCT01256164|141639456|NON_INFERIORITY_OR_EQUIVALENCE|With 90 subjects, randomized on a 2:1 ratio into the Fibrocaps plus gelatin sponge active arm or the gelatin sponge arm, and assuming a mean TTH of 3.5 minutes with a standard deviation of 2.5 minutes in the active arm and a mean TTH of 6 minutes in the control arm, this translates in a power of 99.4% at a two-sided significance level alpha of 5%, using a two-sample t-test.|||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71065190|NCT01256164|141639457|SUPERIORITY_OR_OTHER|||||||1||95.0|||||t-test, 2 sided|||||||1.00
71065191|NCT01256164|141639458|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||Intent-to-treat analysis||||<0.001
71065192|NCT01256164|141639459|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||intent-to- treat analysis||||0.001
71065193|NCT01256164|141639460|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||intent-to-treat analysis||||0.003
71065194|NCT03503370|141639461|SUPERIORITY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.39|1.8|||||Hazard ratio from Cox Proportional Hazard comparing the chlorhexidine group to the placebo group.|||1.80|0.39|
71065195|NCT03503370|141639462|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
71065196|NCT03503370|141639463|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.34|1.77|||||Hazard ratio from Cox Proportional Hazard comparing the chlorhexidine group to the placebo group.|||1.77|0.34|
71065197|NCT01598064|141639483|SUPERIORITY_OR_OTHER|||||||0.25|||||||Chi-squared|||||||0.25
71065198|NCT04506463|141639488|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||||||0.850
71065199|NCT04506463|141639488|SUPERIORITY|||||||0.085|||||||Mixed Models Analysis|||||||0.085
70938105|NCT02291861|141376214|SUPERIORITY||Odds Ratio (OR)|0.69||||0.372|TWO_SIDED|95.0|0.302|1.563||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|||1.563|0.302|0.372
70938106|NCT02291861|141376215|SUPERIORITY||Odds Ratio (OR)|3.8||||0.007|TWO_SIDED|95.0|1.395|10.359||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|||10.359|1.395|0.007
71065200|NCT04506463|141639488|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||||||0.850
71065201|NCT04506463|141639489|SUPERIORITY|||||||0.062|||||||Mixed Models Analysis|||||||0.062
71065202|NCT04506463|141639489|SUPERIORITY|||||||0.007|||||||Mixed Models Analysis|||||||0.007
71065203|NCT04506463|141639489|SUPERIORITY|||||||0.936|||||||Mixed Models Analysis|||||||0.936
71065204|NCT04506463|141639490|SUPERIORITY|||||||0.042|||||||Mixed Models Analysis|||||||0.042
71065205|NCT04506463|141639490|SUPERIORITY|||||||0.037|||||||Mixed Models Analysis|||||||0.037
71065206|NCT04506463|141639490|SUPERIORITY|||||||0.648|||||||Mixed Models Analysis|||||||0.648
71065207|NCT01436370|141639496|SUPERIORITY_OR_OTHER|||||||0.145|||||||Fisher Exact|||This is the comparison for the B/Brisbane/60/2008 strain.||||0.145
71065208|NCT01436370|141639496|SUPERIORITY_OR_OTHER|||||||0.145|||||||Fisher Exact|||This is the comparison for the A/Perth/16/2009 (A/H3N2) strain||||0.145
71065209|NCT01436370|141639496|SUPERIORITY_OR_OTHER|||||||0.999|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain.||||0.999
71065210|NCT01436370|141639504|SUPERIORITY_OR_OTHER|||||||0.182|||||||Fisher Exact|||This is the comparison for the B/Wisconsin/1/2010 strain||||0.182
71065211|NCT01436370|141639504|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain.||||0.500
71065212|NCT01436370|141639504|SUPERIORITY_OR_OTHER|||||||0.087|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain.||||0.087
71065213|NCT01436370|141639505|SUPERIORITY_OR_OTHER|||||||0.234|||||||Fisher Exact|||This is the comparison for the B/Brisbane/60/2008 strain at Day 7.||||0.234
71065214|NCT01436370|141639505|SUPERIORITY_OR_OTHER|||||||0.25|||||||Fisher Exact|||This is the comparison for the B/Brisbane/60/2008 strain at Day 180.||||0.250
71065215|NCT01436370|141639505|SUPERIORITY_OR_OTHER|||||||0.145|||||||Fisher Exact|||This is the comparison for the A/Perth/16/2009 (A/H3N2) strain at Day 7.||||0.145
71065216|NCT01436370|141639505|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||This is the comparison for the A/Perth/16/2009 (A/H3N2) strain at Day 180.||||0.500
71065217|NCT01436370|141639505|SUPERIORITY_OR_OTHER|||||||0.999|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 7.||||0.999
71065218|NCT01436370|141639505|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 180.||||0.500
71065219|NCT01436370|141639506|SUPERIORITY_OR_OTHER|||||||0.716|||||||Fisher Exact|||This is the comparison for the B/Wisconsin/1/2010 strain at Day 7.||||0.716
71065220|NCT01436370|141639506|SUPERIORITY_OR_OTHER|||||||0.999|||||||Fisher Exact|||This is the comparison for the B/Wisconsin/1/2010 strain at Day 180.||||0.999
71065221|NCT01436370|141639506|SUPERIORITY_OR_OTHER|||||||0.503|||||||Fisher Exact|||This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain at Day 7.||||0.503
71065222|NCT01436370|141639506|SUPERIORITY_OR_OTHER|||||||0.475|||||||Fisher Exact|||This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain at Day 180.||||0.475
71065223|NCT01436370|141639506|SUPERIORITY_OR_OTHER|||||||0.182|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 7.||||0.182
71065224|NCT01436370|141639506|SUPERIORITY_OR_OTHER|||||||0.014|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 180.||||0.014
71065225|NCT01436370|141639508|SUPERIORITY_OR_OTHER|||||||0.317|||||||McNemar|||This is the comparison for the B/Brisbane/60/2008 strain at Day 21.||||0.317
71111342|NCT00131352|141729186|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.022|TWO_SIDED|95.0|0.35|0.92|||Generalized Estimating Equations (GEE)|||Estimate of Odds Ratio (Placebo/Synvisc-One) using WOMAC A1 data at Week 26.||0.92|0.35|0.022
71111343|NCT00131352|141729187|SUPERIORITY_OR_OTHER|||||||0.679||95.0|||||ANCOVA|||||||0.679
71065226|NCT01436370|141639508|SUPERIORITY_OR_OTHER|||||||0.564|||||||McNemar|||This is the comparison for the A/Perth/16/2009 (A/H3N2) strain at Day 21.||||0.564
71065227|NCT01436370|141639508|SUPERIORITY_OR_OTHER|||||||0.999|||||||McNemar|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 21.||||0.999
71065228|NCT01436370|141639508|SUPERIORITY_OR_OTHER|||||||0.564|||||||McNemar|||This is the comparison for the B/Brisbane/60/2008 strain at Day 21.||||0.564
71065229|NCT01436370|141639508|SUPERIORITY_OR_OTHER|||||||0.999|||||||McNemar|||This is the comparison for the A/Perth/16/2009 (A/H3N2) strain at Day 21.||||0.999
71065230|NCT01436370|141639508|SUPERIORITY_OR_OTHER|||||||0.655|||||||McNemar|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 21.||||0.655
71065231|NCT01436370|141639509|SUPERIORITY_OR_OTHER|||||||0.18|||||||McNemar|||This is the comparison for the B/Wisconsin/1/2010 strain at Day 21.||||0.180
71065232|NCT01436370|141639509|SUPERIORITY_OR_OTHER|||||||0.763|||||||McNemar|||This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain at Day 21.||||0.763
71111344|NCT00131352|141729188|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||ANCOVA|||||||0.266
70938107|NCT02291861|141376215|SUPERIORITY||Odds Ratio (OR)|3.96||||0.005|TWO_SIDED|95.0|1.46|10.716||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|||10.716|1.460|0.005
71065233|NCT01436370|141639509|SUPERIORITY_OR_OTHER|||||||0.096|||||||McNemar|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 21.||||0.096
71111345|NCT00131352|141729189|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.51||||0.005|TWO_SIDED|95.0|0.31|0.82|||Generalized Estimating Equations (GEE)|||Model-based estimate of Odds Ratio (Placebo/Synvisc-One) using PTGA data at Week 26.||0.82|0.31|0.005
70938108|NCT02291861|141376215|SUPERIORITY||Odds Ratio (OR)|1.13||||0.829|TWO_SIDED|95.0|0.383|3.316||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|||3.316|0.383|0.829
70938109|NCT02291861|141376216|SUPERIORITY||Mean Difference (Final Values)|-21.5|||<|0.001|TWO_SIDED|95.0|-33.44|-9.52||5% level of significance (2-sided). Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo|||-9.52|-33.44|<0.001
71065234|NCT01436370|141639509|SUPERIORITY_OR_OTHER|||||||0.157|||||||McNemar|||This is the comparison for the B/Wisconsin/1/2010 strain at Day 21||||0.157
71065235|NCT01436370|141639509|SUPERIORITY_OR_OTHER|||||||0.705|||||||McNemar|||This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain at Day 21.||||0.705
71111346|NCT00131352|141729190|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.025|TWO_SIDED|95.0|0.34|0.93|||Generalized Estimating Equations (GEE)|||Model-based estimate of Odds Ratio (Placebo/Synvisc-One) using COGA data at Week 26.||0.93|0.34|0.025
71065236|NCT01436370|141639509|SUPERIORITY_OR_OTHER|||||||0.132|||||||McNemar|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 21.||||0.132
71065237|NCT01754129|141639513|OTHER||||||<|0.001||||||Missing values were replaced using the Last Observation Carried Forward (LOCF) technique for data of questionnaires. Missing data at Visit 3 was replaced with the (non-missing) data recorded at Visit 2.|Paired t-test|||Mean change from baseline to Visit 3||||<0.001
71065238|NCT01754129|141639513|OTHER||||||<|0.001|||||||Paired t-test|||Change from baseline to Visit 2||||<0.001
71065239|NCT04229095|141639544|SUPERIORITY||Slope|-4.58|STANDARD_ERROR_OF_MEAN|1.82||0.007|ONE_SIDED|95.0||-1.01|||Mixed Models Analysis||The effect of the drug on lowering VAS was limited to individuals with impaired sleep at baseline (PSQI \> or = to 5).|Mixed effect model with directional hypothesis that drug reduces strength of craving (VAS). Principle predictors were drug condition, and baseline sleep disturbance (Pittsburgh Sleep Quality Index {PSQI} total score less than 5 or 5 and greater). Arms were combined for this analysis.||-1.01||.007
71065240|NCT04229095|141639546|SUPERIORITY||Mean Difference (Net)|-1.52|STANDARD_ERROR_OF_MEAN|0.54||0.0025|ONE_SIDED|95.0||-0.46|||Mixed Models Analysis|||Mixed effect model with directional hypothesis that drug reduces number of drinks per day. Principle predictors were drug condition and sex. Arms were combined for this analysis.||-0.46||.0025
71065241|NCT05483686|141639547|SUPERIORITY|||||||0.19|||||||Regression, Logistic|||This analysis aims to detect a significant change (p = .05) in percentage of participants with HIV transmission risk between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.19
71065242|NCT05483686|141639548|SUPERIORITY||||||=|0.24|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in ART adherence between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||=.24
71065243|NCT05483686|141639549|SUPERIORITY|||||||0.79|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in condom use between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.79
71065244|NCT05483686|141639550|SUPERIORITY|||||||0.81|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in barriers to ART use between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.81
71065245|NCT05483686|141639551|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in barriers to PrEP use between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.14
71065246|NCT05483686|141639552|SUPERIORITY|||||||0.81|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in barriers to condom use between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.81
71111347|NCT00131352|141729191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.156|TWO_SIDED|95.0|0.41|1.16|||Generalized Estimating Equations (GEE)|||Estimate of Odds Ratio (Placebo/Synvisc-One) using Responder classification data at Week 26.||1.16|0.41|0.156
71111348|NCT01194219|141729192|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|27.8|||<|0.0001|TWO_SIDED|95.0|23.1|32.5|||Chi-squared|||||32.5|23.1|<0.0001
71111349|NCT01194219|141729193|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|17.8|||<|0.0001|TWO_SIDED|95.0|13.7|21.9|||Chi-squared|||||21.9|13.7|<0.0001
71065247|NCT05483686|141639553|SUPERIORITY|||||||0.3|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in social support between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.30
70938110|NCT02291861|141376216|SUPERIORITY||Mean Difference (Final Values)|-20.2||||0.001|TWO_SIDED|95.0|-32.57|-7.92||5% level of significance (2-sided). Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo|||-7.92|-32.57|0.001
70938111|NCT02291861|141376216|SUPERIORITY||Mean Difference (Final Values)|-8.4||||0.16|TWO_SIDED|95.0|-20.15|3.34||5% level of significance (2-sided). Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo|||3.34|-20.15|0.160
70938112|NCT01297595|141376235|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|99.58|||||TWO_SIDED|90.0|91.08|108.87||||||Natural log transformed AUC (0 - ∞) of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as a fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. This was an estimation study and there was no formal statistical hypothesis.||108.87|91.08|
70938113|NCT01297595|141376237|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|99.35|||||TWO_SIDED|90.0|90.51|109.07||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as a fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. This was an estimation study and there was no formal statistical hypothesis.||109.07|90.51|
70938114|NCT01297595|141376238|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|96.84|||||TWO_SIDED|90.0|88.22|106.32||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as a fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. This was an estimation study and there was no formal statistical hypothesis.||106.32|88.22|
70938115|NCT01047709|141376249|SUPERIORITY_OR_OTHER||relative % difference|19.5|STANDARD_DEVIATION|23.0||0.011|TWO_SIDED|95.0|4.9|31.9|||GEE||SD of control night|Relative treatment effect on AHI, using GEE modeling, accounting for crossover design.||31.9|4.9|0.011
71065248|NCT05483686|141639554|SUPERIORITY|||||||0.94|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in gender identity comfort between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.94
71065249|NCT01543178|141639563|SUPERIORITY_OR_OTHER|||||||0.0232|TWO_SIDED|||||The a priori threshold for statistical significance was p \< 0.05.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel method was adjusted for analysis center and time to recurrence during Maintenance Phase 1.||A worst case analysis was performed, in which patients with \< 4 days of IBS symptom data in a given week were considered as non-responders for that week.||||0.0232
71111350|NCT01194219|141729194|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-40.78|||<|0.0001|TWO_SIDED|95.0|-46.34|-35.21|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||-35.21|-46.34|<0.0001
70938116|NCT01047709|141376249|SUPERIORITY_OR_OTHER||Relative % difference|19.5|STANDARD_DEVIATION|16.0||0.011||95.0|4.9|31.9|||GEE||SD of intervention night|Relative treatment effect on AHI, using GEE modeling, accounting for crossover design.||31.9|4.9|0.011
71065250|NCT03351608|141639570|SUPERIORITY||GM Ratio (SUG 2 mg / NEO + [GLY or ATR])|0.22|||<|0.0001|TWO_SIDED|95.0|0.16|0.32|||ANOVA|||||0.32|0.16|< 0.0001
71111351|NCT01194219|141729195|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-35.3|||<|0.0001|TWO_SIDED|95.0|-39.9|-30.6|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||-30.6|-39.9|<0.0001
70938117|NCT03015220|141376305|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.5||||0.2963|TWO_SIDED|95.0|0.7|3.2||Unadjusted two-sided p-value for the test of no difference from 1.|Regression, Cox||"Oral Semaglutide 3 mg~/Dulaglutide 0.75 mg"|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||3.20|0.70|0.2963
70941767|NCT04748445|141383935|OTHER||Slope|0.00007664|STANDARD_ERROR_OF_MEAN|2.574||0.7664|TWO_SIDED|90.0|-0.0003499|0.0005032|||Mixed Models Analysis|||READ\_MFCC 1st order delta 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0005032|-0.0003499|0.7664
71111352|NCT01194219|141729196|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|41.7|||<|0.0001|TWO_SIDED|95.0|35.7|47.7|||Chi-squared|||||47.7|35.7|<0.0001
71065251|NCT02877004|141639573|SUPERIORITY|||||||0.723|||||||ANCOVA|Data were analyzed using analysis of covariance with the baseline value included as the covariate.||||||0.723
71065252|NCT02877004|141639574|SUPERIORITY|||||||0.368|||||||ANCOVA|Data were analyzed using analysis of covariance with the baseline value included as the covariate||||||.368
71111353|NCT01194219|141729197|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-24.2|||<|0.0001|TWO_SIDED|95.0|-28.7|-19.8|||ANOVA|Based on an analysis of variance model for the change from baseline at Week 16, with treatment group as a factor (an ANOVA model).||||-19.8|-28.7|<0.0001
71065253|NCT02727478|141639575|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||< 0.001
71065254|NCT02727478|141639576|SUPERIORITY||||||=|0.001|||||||ANOVA|||||||=0.001
71065255|NCT02727478|141639577|OTHER|||||||0.254|||||||Wilcoxon (Mann-Whitney)|||||||0.254
71065256|NCT02727478|141639578|SUPERIORITY||||||=|0.065|||||||Wilcoxon (Mann-Whitney)|||||||=0.065
71065257|NCT02727478|141639579|SUPERIORITY||||||=|0.301|||||||ANOVA|||||||=0.301
70938118|NCT03015220|141376305|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.8||||0.5997|TWO_SIDED|95.0|0.35|1.83||Unadjusted two-sided p-value for the test of no difference from 1.|Regression, Cox||"Oral Semaglutide 7 mg~/Dulaglutide 0.75 mg"|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.83|0.35|0.5997
70938119|NCT03015220|141376305|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.55||||0.1871|TWO_SIDED|95.0|0.23|1.33||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||"Oral Semaglutide 14 mg~/Dulaglutide 0.75 mg"|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.33|0.23|0.1871
70938120|NCT03015220|141376306|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.9||||0.1672|TWO_SIDED|95.0|0.76|4.72||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||"Oral Semaglutide 3 mg~/Dulaglutide 0.75 mg"|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||4.72|0.76|0.1672
70938121|NCT03015220|141376306|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.6||||0.3391|TWO_SIDED|95.0|0.21|1.72||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||"Oral Semaglutide 7 mg~/Dulaglutide 0.75 mg"|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||1.72|0.21|0.3391
70938122|NCT03015220|141376306|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.12||||0.011|TWO_SIDED|95.0|0.02|0.62||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||"Oral Semaglutide 14 mg~/Dulaglutide 0.75 mg"|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.62|0.02|0.0110
70938123|NCT02291549|141376323|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.0074|TWO_SIDED|95.0|-0.39|-0.06||The 2-sided alpha was 0.05. P-value was not adjusted for multiple comparison.|ANCOVA|Where appropriate, confidence intervals of the difference were constructed using the estimate of the least-squares means||ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups. The primary efficacy hypothesis was that the use of the S8 Sinus Implant would reduce the Nasal Obstruction/Congestion score compared to the control group. The null hypothesis was H0: β1=0 and alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.||-0.06|-0.39|0.0074
71065258|NCT02727478|141639580|SUPERIORITY||||||=|0.792|||||||ANOVA|||||||=0.792
71065259|NCT02727478|141639581|OTHER|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
71111354|NCT01194219|141729198|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-4.5|||<|0.0001|TWO_SIDED|95.0|-5.4|-3.6|||ANOVA||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor, the baseline value, and the treatment by baseline interaction term as covariates.|||-3.6|-5.4|<0.0001
71111355|NCT01194219|141729199|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.08|||<|0.0001|TWO_SIDED|95.0|1.81|4.35|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||4.35|1.81|<0.0001
71111356|NCT01194219|141729200|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|16.7|||<|0.0001|TWO_SIDED|95.0|12.8|20.7|||Chi-squared|||||20.7|12.8|<0.0001
70938124|NCT02291549|141376324|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.0073|TWO_SIDED|95.0|-0.6|-0.09||The 2-sided alpha was 0.05. P-value was not adjusted for multiple comparisons.|ANCOVA|ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups.||The between treatment group difference was estimated using the ANCOVA model with site and treatment group as fixed effects. The primary efficacy hypothesis was that the use of the S8 Sinus Implant would reduce the bilateral polyp grade compared to the control group. The null hypothesis was H0: β1=0 and alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.||-0.09|-0.60|0.0073
70938125|NCT02291549|141376325|SUPERIORITY||Odds Ratio (OR)|2.69||||0.0004|TWO_SIDED|95.0|1.63|4.44||P-value adjusted for multiplicity using the Holm's step-down procedure at a 2-sided significance level of 0.05.|Cochran-Mantel-Haenszel|Adjusted p-value is presented.||Test: H0: OR = 1 vs. OR ≠ 1 by Cochrane-Mantel-Haenszel test||4.44|1.63|0.0004
70941768|NCT04748445|141383935|OTHER||Slope|-1.708|STANDARD_ERROR_OF_MEAN|2.028||0.4015|TWO_SIDED|90.0|-5.069|1.654|||Mixed Models Analysis|||READ\_MFCC 1st order delta 05 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||1.654|-5.069|0.4015
71065260|NCT00375973|141639651|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Regression, Linear|||||||0.23
71065261|NCT00375973|141639652|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Regression, Linear|||||||0.05
71065262|NCT00375973|141639653|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Regression, Linear|||||||0.67
71065263|NCT00375973|141639654|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Regression, Linear|||||||0.02
71065264|NCT00375973|141639655|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Regression, Linear|||||||0.06
71065265|NCT00375973|141639656|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Fisher Exact|||||||0.02
71065266|NCT00375973|141639657|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||Fisher Exact|||||||0.24
71111357|NCT01194219|141729201|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.649|||<|0.0001|TWO_SIDED|95.0|1.768|3.969|||Log Rank|||||3.969|1.768|<0.0001
71111358|NCT04474197|141729218|SUPERIORITY||Least Squares (LS) Mean Difference|2.3|||<|0.0001|TWO_SIDED|95.0|1.5|3.1|||Mixed-effects Model for Repeated Measure|||||3.1|1.5|<0.0001
70938126|NCT02291549|141376326|SUPERIORITY||Mean Difference (Final Values)|-7.96||||0.0007|TWO_SIDED|95.0|-12.1|-3.83||P-value adjusted for multiplicity using the Holm's step-down procedure at a 2-sided significance level of 0.05.|ANCOVA|Adjusted p-value is presented.||ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups.The null hypothesis was H0: β1 = 0 and the alternative hypothesis was H1: β1 ≠ 0. Although the alternative hypothesis was specified as 2-sided, only a statistically significant, negative estimate of β1 constituted evidence of effectiveness. The 2-sided alpha for this test was 0.05.||-3.83|-12.10|0.0007
70938127|NCT02291549|141376327|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.0248|TWO_SIDED|95.0|-0.48|-0.07||P-value adjusted for multiplicity using the Holm's step-down procedure at a 2-sided significance level of 0.05.|ANCOVA|Adjusted p-value is presented.||ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups. The null hypothesis was H0: β1=0 and the alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.||-0.07|-0.48|0.0248
70938128|NCT02291549|141376328|SUPERIORITY||Mean Difference (Final Values)|-0.46||||0.047|TWO_SIDED|95.0|-0.85|-0.06||P-value adjusted for multiplicity using the Holm's step-down procedure at a 2-sided significance level of 0.05.|ANCOVA|The adjusted p-value is presentenced.||ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups. The null hypothesis was H0: β1=0 and alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.||-0.06|-0.85|0.0470
70938129|NCT02291549|141376329|SUPERIORITY|||||||0.913||||||P-value adjusted for multiplicity using the Holm's step-down procedure at a 2-sided significance level of 0.05.|ANCOVA|Adjusted p-value is presented.||ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups. The null hypothesis was H0: β1=0 and alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.||||0.9130
70938130|NCT01970527|141376341|SUPERIORITY|||||||0.67|||||||Log Rank|||||||0.67
70938131|NCT01970527|141376343|SUPERIORITY|||||||0.71|||||||Log Rank|||||||0.71
71111359|NCT04474197|141729218|SUPERIORITY||LS Mean Difference|2.3|||<|0.0001|TWO_SIDED|95.0|1.6|3.1|||Mixed-effects Model for Repeated Measure|||||3.1|1.6|<0.0001
70938132|NCT01115309|141376345|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 is considered statistically significant.|t-test, 2 sided|||||||<0.0001
70938133|NCT01115309|141376346|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 is considered statistically significant.|t-test, 2 sided|||||||<0.0001
70938134|NCT04447287|141376365|OTHER||Geometric LS Mean Ratio|89.72|||||TWO_SIDED|90.0|81.21|99.11||||||||99.11|81.21|
70938135|NCT04447287|141376366|OTHER||Geometric LS Mean Ratio|92.15|||||TWO_SIDED|90.0|80.22|105.86||||||||105.86|80.22|
70938136|NCT04447287|141376367|OTHER||Geometric LS Mean Ratio|109.09|||||TWO_SIDED|90.0|101.1|117.71||||||||117.71|101.10|
70938137|NCT04447287|141376368|OTHER||Geometric LS Mean Ratio|117.77|||||TWO_SIDED|90.0|106.41|130.34||||||||130.34|106.41|
71111360|NCT04474197|141729218|SUPERIORITY||LS Mean Difference|2.2|||<|0.0001|TWO_SIDED|95.0|1.5|2.9|||Mixed-effects Model for Repeated Measure|||||2.9|1.5|<0.0001
70938138|NCT04447287|141376369|OTHER||Geometric LS Mean Ratio|79.39|||||TWO_SIDED|90.0|68.1|92.55||||||||92.55|68.10|
70938139|NCT04447287|141376370|OTHER||Geometric LS Mean Ratio|74.45|||||TWO_SIDED|90.0|59.28|93.5||||||||93.50|59.28|
70938140|NCT03246724|141376384|NON_INFERIORITY|A non-inferiority margin of 0.5, will assure that, if non-inferiority is proven, the mean patient satisfaction with oral sedation will correspond to scores corresponding to satisfied or higher. A 0.5 margin to be considered clinically similar enough to declare non-inferiority because it allows for expected patient satisfaction variability, and demonstrates ample justification for providers to offer oral sedation as a safe alternative.|||||<|0.05||||||As a sensitivity analysis, an ANCOVA model will be fit to the data adjusting for factors that are out of balance following randomization. The mean difference between the adjusted means will be calculated.|ANCOVA|If lower bound of the 90% two-sided Confidence Interval of mean difference is higher than -0.5, the oral sedation will be deemed non-inferior to IV.||"Testable hypothesis: Patient satisfaction mean will be non-inferior when given oral triazolam in comparison to IV midazolam during all basic cataracts, retina, cornea, and glaucoma ocular procedures.~Null hypothesis: The null hypothesis is that the oral sedation group will have a primary endpoint mean equal to or less than that of the IV sedation group by the non-inferiority margin or more."||||<0.05
70938141|NCT03246724|141376385|NON_INFERIORITY|A non-inferiority margin of 0.5, will assure that, if non-inferiority is proven, the mean patient satisfaction with oral sedation will correspond to scores corresponding to satisfied or higher. We determined a 0.5 margin to be considered clinically similar enough to declare non-inferiority because it allows for expected patient satisfaction variability, and demonstrates ample justification for providers to offer oral sedation as a safe alternative.|||||<|0.05||||||Surgeon satisfaction score will be independently analyzed. Summary statistics including, means, standard deviations along with points estimates of the mean difference between the two groups and 90% Confidence Intervals.|ANCOVA|If lower bound of the 90% two-sided Confidence Interval of mean difference is higher than -0.5, oral sedation will be deemed non-inferior to IV.||"Null hypothesis: Mean surgeon satisfaction score for oral triazolam will be statistically significant in comparison to mean surgeon satisfaction score for IV midazolam during all cataracts, retina, cornea, and glaucoma ocular procedures.~Alternate hypothesis: Mean surgeon satisfaction score for oral triazolam will not be statistically significant in comparison to mean surgeon satisfaction score for IV midazolam during all cataracts, retina, cornea, and glaucoma ocular procedures."||||<0.05
71111361|NCT04474197|141729220|SUPERIORITY||LS Mean Difference|3.5|||<|0.0001|TWO_SIDED|95.0|2.4|4.6|||Mixed-effects Model for Repeated Measure|||||4.6|2.4|<0.0001
71111362|NCT04474197|141729220|SUPERIORITY||LS Mean Difference|3.0|||<|0.0001|TWO_SIDED|95.0|1.9|4.0|||Mixed-effects Model for Repeated Measure|||||4.0|1.9|<0.0001
71111363|NCT04474197|141729220|SUPERIORITY||LS Mean Difference|2.7|||<|0.0001|TWO_SIDED|95.0|1.8|3.7|||Mixed-effects Model for Repeated Measure|||||3.7|1.8|<0.0001
71111364|NCT00635349|141729229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower confidence limit interval was less than -1.0 (1-sided , 97.5% confidence interval)|Mean Difference (Final Values)|1.81||||0.4258|ONE_SIDED|97.5|-6.31||||t-test, 1 sided||||||-6.31|0.4258
70938142|NCT03246724|141376386|NON_INFERIORITY|A non-inferiority margin of 0.5, will assure that, if non-inferiority is proven, the mean patient satisfaction with oral sedation will correspond to scores corresponding to satisfied or higher. We determined a 0.5 margin to be considered clinically similar enough to declare non-inferiority because it allows for expected patient satisfaction variability, and demonstrates ample justification for providers to offer oral sedation as a safe alternative.|||||<|0.05||||||Anesthesiologist/CRNA satisfaction score will be independently analyzed. Summary statistics including, means, standard deviations along with points estimates of the mean difference between the two groups and 90% Confidence Intervals.|ANCOVA|If lower bound of the 90% two-sided Confidence Interval of mean difference is higher than -0.5, the oral sedation will be deemed non-inferior to IV.||"Null hypothesis: Mean anesthesiologist/CRNA satisfaction score for oral triazolam will be statistically significant in comparison to mean anesthesiologist/CRNA satisfaction score for IV midazolam during cataracts, retina, cornea, and glaucoma procedures.~Alternate hypothesis:Mean anesthesiologist/CRNA satisfaction score for oral triazolam will not be statistically significant in comparison to mean satisfaction score for IV midazolam during cataracts, retina, cornea, and glaucoma procedures."||||<0.05
70938143|NCT03246724|141376387|OTHER|Additional anesthesia intervention will be using summary statistics including, counts and proportions along with point's estimates of the proportion difference between the two groups and 90% Confidence Intervals.|||||<|0.05|||||||t-test, 2 sided|||"Null hypothesis:The total additional anesthesia interventions for oral triazolam will be statistically significant in comparison to additional anesthesia interventions for IV midazolam during cataracts, retina, cornea, and glaucoma procedures.~Alternate hypothesis:The total additional anesthesia interventions for oral triazolam will not be statistically significant in comparison to additional anesthesia interventions for IV midazolam during cataracts, retina, cornea, and glaucoma procedures"||||<0.05
70938144|NCT03246724|141376388|OTHER|Surgical complications will be using summary statistics including, counts and proportions along with point's estimates of the proportion difference between the two groups and 90% Confidence Intervals.|||||<|0.05|||||||t-test, 2 sided|||"Null hypothesis: The total surgical complications for oral triazolam will be statistically significant in comparison to total surgical complications for IV midazolam during all cataracts, retina, cornea, and glaucoma ocular procedures.~Alternate hypothesis: The total surgical complications for oral triazolam will not be statistically significant in comparison to total surgical complications for IV midazolam during all cataracts, retina, cornea, and glaucoma ocular procedures."||||<0.05
70938145|NCT01307800|141376437|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.1|STANDARD_ERROR_OF_MEAN|2.4||0.994|TWO_SIDED|95.0|-0.5|8.8||The comparison between 80 mg LY2140023, BID and placebo was conducted at a 1-sided alpha level of 0.025, with adjustment for multiplicity by applying the Step-down Dunnett procedure.|Mixed Models Analysis|||||8.8|-0.5|0.994
70938146|NCT01307800|141376437|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.0|STANDARD_ERROR_OF_MEAN|2.5||0.973|TWO_SIDED|95.0|-1.9|7.9||The comparison between 40 mg LY2140023, BID and placebo was conducted at a 1-sided alpha level of 0.025, with adjustment for multiplicity by applying the Step-down Dunnett procedure.|Mixed Models Analysis|||||7.9|-1.9|0.973
70938147|NCT01307800|141376437|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.8|STANDARD_ERROR_OF_MEAN|2.2||0.896|TWO_SIDED|95.0|-1.6|7.2||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||7.2|-1.6|0.896
70938148|NCT01307800|141376438|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.3|STANDARD_ERROR_OF_MEAN|2.5||0.955|TWO_SIDED|95.0|-0.7|9.3||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||9.3|-0.7|0.955
70938149|NCT01307800|141376438|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.4|STANDARD_ERROR_OF_MEAN|2.5||0.912|TWO_SIDED|95.0|-1.6|8.4||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||8.4|-1.6|0.912
70938150|NCT01307800|141376438|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.9|STANDARD_ERROR_OF_MEAN|2.4||0.223|TWO_SIDED|95.0|-1.8|7.7||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||7.7|-1.8|0.223
70938151|NCT01307800|141376439|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|1.5||0.61|TWO_SIDED|95.0|-3.5|2.6||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.6|-3.5|0.610
70938152|NCT01307800|141376439|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.3|STANDARD_ERROR_OF_MEAN|1.7||0.223|TWO_SIDED|95.0|-2.0|4.6||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||4.6|-2.0|0.223
71111365|NCT00635349|141729230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.0628|ONE_SIDED|97.5|-1.41||||t-test, 1 sided||||||-1.41|0.0628
71111366|NCT00635349|141729231|SUPERIORITY_OR_OTHER|||||||0.0131||||||Day 29: p-value was calculated by fisher exact test|Fisher Exact|||||||0.0131
70938153|NCT01307800|141376439|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.2|STANDARD_ERROR_OF_MEAN|1.5||0.414|TWO_SIDED|95.0|-4.2|1.7||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||1.7|-4.2|0.414
70938154|NCT01307800|141376440|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|1.6||0.603|TWO_SIDED|95.0|-3.7|2.8||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.8|-3.7|0.603
70938155|NCT01307800|141376440|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.5|STANDARD_ERROR_OF_MEAN|1.7||0.192|TWO_SIDED|95.0|-1.9|4.8||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||4.8|-1.9|0.192
71111367|NCT00635349|141729231|SUPERIORITY_OR_OTHER|||||||0.9834||||||Day 57; p-value was calculated by Chi-squared test|Chi-squared|||||||0.9834
71111368|NCT00635349|141729231|SUPERIORITY_OR_OTHER|||||||0.1131||||||Day 85; p-value was calculated by Chi-squared test|Chi-squared|||||||0.1131
71111369|NCT03951766|141729281|SUPERIORITY||Mean Difference (Final Values)|-1.5|||<|0.0001|TWO_SIDED|95.0|-1.9|-1.1||The a priori threshold for statistical significance was alpha=.05. We did not adjust for multiple comparisons, because this was a secondary outcome. The p-value is for a planned specific comparison of week 6 to baseline.|t-test, 2 sided|||||-1.1|-1.9|<.0001
70938156|NCT01307800|141376440|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|1.6||0.619|TWO_SIDED|95.0|-3.9|2.3||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.3|-3.9|0.619
70938157|NCT01307800|141376441|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|9.5|STANDARD_ERROR_OF_MEAN|4.1||0.022|TWO_SIDED|95.0|1.4|17.6||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||17.6|1.4|0.022
70938158|NCT01307800|141376441|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|8.7|STANDARD_ERROR_OF_MEAN|4.6||0.061|TWO_SIDED|95.0|-0.4|17.8||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||17.8|-0.4|0.061
70938159|NCT01307800|141376441|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.2|STANDARD_ERROR_OF_MEAN|4.1||0.304|TWO_SIDED|95.0|-3.9|12.3||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||12.3|-3.9|0.304
70938160|NCT01307800|141376442|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.6|STANDARD_ERROR_OF_MEAN|0.8||0.036|TWO_SIDED|95.0|0.1|3.1||The comparison between 80 mg LY2140023, BID and placebo for the change from baseline in PANSS positive subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||3.1|0.1|0.036
70938161|NCT01307800|141376442|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.8||0.616|TWO_SIDED|95.0|-1.2|2.0||The comparison between 40 mg LY2140023, BID and placebo for change from baseline in PANSS positive subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.0|-1.2|0.616
71111370|NCT03951766|141729282|SUPERIORITY||Median Difference (Final Values)|-24.9|||<|0.0001|TWO_SIDED|95.0|-32.7|-17.1||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-17.1|-32.7|<.0001
71111371|NCT03951766|141729283|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.06|TWO_SIDED|95.0|0.0|0.4||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6|t-test, 2 sided|||PANAS positive affect||0.4|-0.0|0.06
70938162|NCT01307800|141376442|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.7||0.307|TWO_SIDED|95.0|-0.7|2.2||The comparison between 10 mg LY2140023, BID and placebo for change from baseline in PANSS positive subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.2|-0.7|0.307
70938163|NCT01307800|141376442|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.7||0.382|TWO_SIDED|95.0|-0.8|2.1||The comparison between 80 mg LY2140023, BID and placebo for the change from baseline in PANSS negative subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.1|-0.8|0.382
70938164|NCT01307800|141376442|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.3|STANDARD_ERROR_OF_MEAN|0.8||0.107|TWO_SIDED|95.0|-0.3|2.8||The comparison between 40 mg LY2140023, BID and placebo for the change from baseline in PANSS negative subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.8|-0.3|0.107
70938165|NCT01307800|141376442|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.7||0.436|TWO_SIDED|95.0|-0.9|2.0||The comparison between 10 mg LY2140023, BID and placebo for the change from baseline in PANSS negative subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.0|-0.9|0.436
70938166|NCT01307800|141376442|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.3|STANDARD_ERROR_OF_MEAN|1.3||0.073|TWO_SIDED|95.0|-0.2|4.9||The comparison between 80 mg LY2140023, BID and placebo for the change from baseline in PANSS general psychopathology subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||4.9|-0.2|0.073
70938167|NCT01307800|141376442|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.5|STANDARD_ERROR_OF_MEAN|1.4||0.28|TWO_SIDED|95.0|-1.2|4.2||The comparison between 40 mg LY2140023, BID and placebo for the change from baseline in PANSS general psychopathology subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||4.2|-1.2|0.280
70938168|NCT01307800|141376442|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.6|STANDARD_ERROR_OF_MEAN|1.3||0.209|TWO_SIDED|95.0|-0.9|4.0||The comparison between 10 mg LY2140023, BID and placebo for the change from baseline in PANSS general psychopathology subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||4.0|-0.9|0.209
70938169|NCT01307800|141376443|SUPERIORITY_OR_OTHER_LEGACY|||||||0.137||95.0||||The p-value was 2-sided without adjustment for multiplicity.|Fisher Exact|||||||0.137
70938170|NCT01307800|141376443|SUPERIORITY_OR_OTHER_LEGACY|||||||0.824||95.0||||The p-value was 2-sided without adjustment for multiplicity.|Fisher Exact|||||||0.824
70938171|NCT01307800|141376443|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999||95.0||||The p-value was 2-sided without adjustment for multiplicity.|Fisher Exact|||||||>0.999
70938172|NCT01307800|141376445|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.13||0.34|TWO_SIDED|95.0|-0.13|0.38||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||0.38|-0.13|0.340
70938173|NCT01307800|141376445|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.14||0.659|TWO_SIDED|95.0|-0.33|0.21||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||0.21|-0.33|0.659
71111372|NCT03951766|141729283|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.36|TWO_SIDED|95.0|-0.4|0.1||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||PANAS negative affect||0.1|-0.4|0.36
70938174|NCT01307800|141376445|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.413|TWO_SIDED|95.0|-0.14|0.35||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||0.35|-0.14|0.413
71065267|NCT01691560|141639684|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.09||||0.4553|TWO_SIDED|95.0|-0.14|0.32|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.32|-0.14|0.4553
71065268|NCT01691560|141639684|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.07||||0.5689|TWO_SIDED|95.0|-0.16|0.3|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.30|-0.16|0.5689
71065269|NCT01691560|141639684|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.04||||0.7517|TWO_SIDED|95.0|-0.2|0.27|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.27|-0.20|0.7517
71065270|NCT01691560|141639684|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.02||||0.8549|TWO_SIDED|95.0|-0.21|0.25|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.25|-0.21|0.8549
71065271|NCT01691560|141639684|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.05||||0.6685|TWO_SIDED|95.0|-0.18|0.29|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.29|-0.18|0.6685
71065272|NCT01691560|141639684|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03||||0.8031|TWO_SIDED|95.0|-0.26|0.2|||ANCOVA||Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.20|-0.26|0.8031
71065273|NCT01691560|141639685|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0467|TWO_SIDED|95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|0|0.0467
71065274|NCT01691560|141639685|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.1133|TWO_SIDED|95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test.|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|0|0.1133
71065275|NCT01691560|141639685|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.2579||95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|0|0.2579
71065276|NCT01691560|141639685|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.6149|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test.|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0|0|0.6149
71065277|NCT01691560|141639685|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.3259|TWO_SIDED|95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|0|0.3259
71065278|NCT01691560|141639685|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.5721|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0|0|0.5721
71065279|NCT01691560|141639686|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.36||||0.0292|TWO_SIDED|95.0|0.04|0.69|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.69|0.04|0.0292
71065280|NCT01691560|141639686|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.12||||0.4484|TWO_SIDED|95.0|-0.44|0.2|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.20|-0.44|0.4484
71065281|NCT01691560|141639686|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.12||||0.4537|TWO_SIDED|95.0|-0.45|0.2|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.20|-0.45|0.4537
70852664|NCT01578850|141194327|SUPERIORITY_OR_OTHER||Difference in proportions|30.9|||<|0.001|TWO_SIDED|95.0|21.03|40.76|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 44||40.76|21.03|<0.001
71111373|NCT03951766|141729284|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.1627|TWO_SIDED|95.0|-0.1|0.4||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.4|-0.1|0.1627
71111374|NCT03951766|141729285|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.62|TWO_SIDED|95.0|-3.8|6.3||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||Single-item - past week||6.3|-3.8|0.62
71111375|NCT03951766|141729285|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.83|TWO_SIDED|95.0|-5.4|4.4||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||Single-item - right now||4.4|-5.4|0.83
71111376|NCT03951766|141729286|SUPERIORITY||Mean Difference (Final Values)|13.1|||<|0.0001|TWO_SIDED|95.0|7.6|18.7||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||SEQ-12 - Internal||18.7|7.6|<.0001
71111377|NCT03951766|141729286|SUPERIORITY||Mean Difference (Final Values)|11.1|||<|0.0001|TWO_SIDED|95.0|6.1|16.1|||t-test, 2 sided|||SEQ-12 - External||16.1|6.1|<.0001
70852665|NCT01578850|141194327|SUPERIORITY_OR_OTHER||Difference in proportions|20.6|||<|0.001|TWO_SIDED|95.0|11.78|29.52|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 52||29.52|11.78|<0.001
70938175|NCT01307800|141376446|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|1.5||0.91|TWO_SIDED|95.0|-3.1|2.7||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.7|-3.1|0.910
71065282|NCT01691560|141639686|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.49||||0.0037|TWO_SIDED|95.0|0.16|0.81|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.81|0.16|0.0037
71065283|NCT01691560|141639686|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.48||||0.004|TWO_SIDED|95.0|0.16|0.81|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Treatment as fixed factor, baseline Schiff score as covariate. Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.81|0.16|0.0040
71065284|NCT01691560|141639686|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0||||0.9974|TWO_SIDED|95.0|-0.32|0.32|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.32|-0.32|0.9974
71065285|NCT01691560|141639687|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.8861|TWO_SIDED|95.0|-5.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|-5|0.8861
71065286|NCT01691560|141639687|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0641|TWO_SIDED|95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|0|0.0641
71065287|NCT01691560|141639687|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.1831||95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|0|0.1831
71065288|NCT01691560|141639687|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0871|TWO_SIDED|95.0|-10.0|0.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0|-10|0.0871
70938176|NCT01307800|141376446|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.8|STANDARD_ERROR_OF_MEAN|1.6||0.265|TWO_SIDED|95.0|-4.9|1.3||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||1.3|-4.9|0.265
70938177|NCT01307800|141376446|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|1.4||0.531|TWO_SIDED|95.0|-3.7|1.9||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||1.9|-3.7|0.531
71111378|NCT03951766|141729287|SUPERIORITY||Mean Difference (Final Values)|5.5||||0.0126|TWO_SIDED|95.0|1.2|9.8||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||9.8|1.2|0.0126
71111379|NCT03951766|141729288|SUPERIORITY||Mean Difference (Final Values)|-6.6||||0.0053|TWO_SIDED|95.0|-11.1|-2.0||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-2.0|-11.1|0.0053
71111380|NCT03951766|141729289|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.76|TWO_SIDED|95.0|-0.1|0.2||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||ATS - Adverse Effects||0.2|-0.1|0.76
71111381|NCT03951766|141729289|SUPERIORITY||Mean Difference (Final Values)|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.5||The a priori threshold for statistical significance was alpha=.05. We did not adjust for multiple comparisons, because this was a secondary outcome. The p-value is for a planned specific comparison of week 6 to baseline.|t-test, 2 sided|||ATS - Psychoactive Benefits||-0.5|-1.0|<.0001
71065289|NCT01691560|141639687|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.169|TWO_SIDED|95.0|-10.0|0.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0|-10|0.1690
71065290|NCT01691560|141639687|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.3829|TWO_SIDED|95.0|-5.0|0.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0|-5|0.3829
71065291|NCT01691560|141639688|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.03||||0.9421|TWO_SIDED|95.0|-0.74|0.8|||ANCOVA|ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.80|-0.74|0.9421
71065292|NCT01691560|141639688|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.15||||0.6918|TWO_SIDED|95.0|-0.9|0.6|||ANCOVA|ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.60|-0.90|0.6918
71065293|NCT01691560|141639688|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.13||||0.7421|TWO_SIDED|95.0|-0.63|0.88|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.88|-0.63|0.7421
71065294|NCT01691560|141639688|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.18||||0.6433|TWO_SIDED|95.0|-0.58|0.94|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.94|-0.58|0.6433
71065295|NCT01691560|141639688|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.1||||0.801|TWO_SIDED|95.0|-0.86|0.67|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.67|-0.86|0.8010
71065296|NCT01691560|141639688|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.28||||0.4692|TWO_SIDED|95.0|-0.48|1.03|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||1.03|-0.48|0.4692
71065297|NCT01691560|141639689|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.31||||0.4797|TWO_SIDED|95.0|-0.55|1.16|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||1.16|-0.55|0.4797
71065298|NCT01691560|141639689|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.54||||0.2023|TWO_SIDED|95.0|-1.37|0.29|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.29|-1.37|0.2023
71065299|NCT01691560|141639689|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.45||||0.2917|TWO_SIDED|95.0|-1.29|0.39|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.39|-1.29|0.2917
71065300|NCT01691560|141639689|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.85||||0.0503|TWO_SIDED|95.0|0.0|1.69|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||1.69|0.00|0.0503
71065301|NCT01691560|141639689|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.76||||0.0811|TWO_SIDED|95.0|-0.09|1.61|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||1.61|-0.09|0.0811
71065302|NCT01691560|141639689|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.09||||0.8322|TWO_SIDED|95.0|-0.75|0.93|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.93|-0.75|0.8322
71065303|NCT02019264|141639735|NON_INFERIORITY|Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates. MACE met non-inferiority when the one-sided upper bound of 97.5% confidence interval of the HR was less than 1.4 (the non-inferiority margin).|Hazard Ratio (HR)|1.005||||0.0001|TWO_SIDED|97.5|0.842|1.198|||Primary Analytic Method|||||1.198|0.842|0.0001
71065304|NCT02019264|141639736|SUPERIORITY|Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|0.969||||0.5464|TWO_SIDED|95.0|0.873|1.074|||Primary Analytic Method|||||1.074|0.873|0.5464
71065305|NCT02019264|141639737|SUPERIORITY|Hazard ratio was based on Cox-regression model including treatment as covariate.|Hazard Ratio (HR)|0.807||||0.038|TWO_SIDED|95.0|0.659|0.988|||Primary Analytic Method|||||0.988|0.659|0.0380
71065306|NCT02019264|141639738|NON_INFERIORITY|Myocardial Infarction: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates. 97.5% confidence interval refers to the upper limit of the displayed 2-sided 95% confidence interval.|Hazard Ratio (HR)|0.991||||0.0001|TWO_SIDED|97.5|0.824|1.191|||Primary Analytic Method|||||1.191|0.824|0.0001
71065307|NCT02019264|141639738|NON_INFERIORITY|Time to Stroke: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates. 97.5% CI refers to the upper limit of the displayed 2-sided 95% CI.|Hazard Ratio (HR)|0.856||||0.0005|TWO_SIDED|97.5|0.639|1.145|||Primary Analytic Method|||||1.145|0.639|0.0005
71065308|NCT02019264|141639738|NON_INFERIORITY|Cardiovascular Death: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates. 97.5% confidence interval refers to the upper limit of the displayed 2-sided 95% confidence interval.|Hazard Ratio (HR)|1.045||||0.0262|TWO_SIDED|97.5|0.778|1.404|||Primary Analytic Method|||||1.404|0.778|0.0262
71065309|NCT02019264|141639738|SUPERIORITY|Hospitalization for Unstable Angina: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|1.163||||0.3243|TWO_SIDED|95.0|0.861|1.571|||Primary Analytic Method|||||1.571|0.861|0.3243
71065310|NCT02019264|141639738|SUPERIORITY|Heart Failure: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|0.952||||0.6758|TWO_SIDED|95.0|0.757|1.197|||Primary Analytic Method|||||1.197|0.757|0.6758
71065311|NCT02019264|141639738|SUPERIORITY|Coronary Revascularization: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|0.981||||0.7817|TWO_SIDED|95.0|0.856|1.125|||Primary Analytic Method|||||1.125|0.856|0.7817
71065312|NCT02019264|141639739|SUPERIORITY|Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|1.082||||0.4212|TWO_SIDED|95.0|0.893|1.31|||Primary Analytic Method|||||1.310|0.893|0.4212
71065313|NCT02019264|141639740|SUPERIORITY|Hazard ratio was based on a Cox regression model including treatment as covariate.|Hazard Ratio (HR)|1.124||||0.181|TWO_SIDED|95.0|0.947|1.333|||Primary Analytic Method|||||1.333|0.947|0.1810
71065314|NCT02019264|141639741|SUPERIORITY|Hazard ratio was based on a Cox regression model including treatment as covariate.|Hazard Ratio (HR)|0.773||||0.0116|TWO_SIDED|95.0|0.633|0.944|||Primary Analytic Method|||||0.944|0.633|0.0116
71065315|NCT02019264|141639742|SUPERIORITY||Least square (LS) Mean Difference (Net)|-0.39|||<|0.0001|TWO_SIDED|95.0|-0.43|-0.35||P-value was based on analysis of covariance (ANCOVA) model with treatment and stratification variable (presence of established CV disease or CV risk factors without established CV disease) as factors, and baseline HbA1c, as a covariate.|ANCOVA|||||-0.35|-0.43|<0.0001
71065316|NCT02019264|141639743|SUPERIORITY|Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|0.869||||0.0054|TWO_SIDED|95.0|0.787|0.959|||Primary Analytic Method|||||0.959|0.787|0.0054
71111382|NCT03951766|141729289|SUPERIORITY||Mean Difference (Final Values)|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.3||The a priori threshold for statistical significance was alpha=.05. We did not adjust for multiple comparisons, because this was a secondary outcome. The p-value is for a planned specific comparison of week 6 to baseline.|t-test, 2 sided|||ATS - Pleasure||-0.3|-0.8|<.0001
71065317|NCT02019264|141639744|SUPERIORITY|Hazard ratio on a Cox regression model including treatment as covariate.|Hazard Ratio (HR)|0.904||||0.3661|TWO_SIDED|95.0|0.727|1.125|||Primary Analytic Method|||||1.125|0.727|0.3661
71065318|NCT02019264|141639745|SUPERIORITY||Hazard Ratio (HR)|0.855||||0.0082|TWO_SIDED|95.0|0.762|0.96|||Primary Analytic Method|||||0.960|0.762|0.0082
71065319|NCT02019264|141639746|SUPERIORITY|Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|1.182||||0.0297|TWO_SIDED|95.0|1.017|1.375|||Primary Analytic Method|||||1.375|1.017|0.0297
71065320|NCT02019264|141639747|SUPERIORITY||Odds Ratio (OR)|1.21||||0.5015|TWO_SIDED|95.0|0.69|2.11||P-value was based on logistic regression including treatment as a factor and baseline body mass index (BMI) as a covariate.|Regression, Logistic|||||2.11|0.69|0.5015
71065321|NCT02019264|141639748|SUPERIORITY||Odds Ratio (OR)|1.31||||0.7249|TWO_SIDED|95.0|0.29|5.98||P-value was based on logistic regression including treatment as a factor and baseline BMI as a covariate.|Regression, Logistic|||||5.98|0.29|0.7249
71065322|NCT02019264|141639749|SUPERIORITY||Least square (LS) Mean Difference (Net)|-0.9036||||0.2976|TWO_SIDED|95.0|-1.2908|-0.5163||P value was based on a mixed-effects model (unstructured covariance matrix) with repeated measures with treatment, month and treatment by month interaction as factors and baseline pulmonary arterial systolic pressure and baseline BMI as covariates.|Mixed-effects model|||||-0.5163|-1.2908|0.2976
71065323|NCT01511978|141639750|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71065324|NCT01511978|141639751|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
71065325|NCT01737710|141639768|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.082|TWO_SIDED|95.0|0.92|3.55||Null hypothesis: no difference in the percent of participants that were seroprotected against influenza B at Day 28 between the two groups.|Fisher Exact|||||3.55|0.92|0.082
71065326|NCT01737710|141639769|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.801|TWO_SIDED|95.0|0.26|2.56||Null hypothesis: no difference in the percent of participants that were seroprotected against influenza H1N1 at Day 28 between the two groups|Fisher Exact|||||2.56|0.26|0.801
71111383|NCT03951766|141729290|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.25|TWO_SIDED|95.0|-0.3|0.1||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.1|-0.3|0.25
71111384|NCT03951766|141729291|SUPERIORITY|DBI - Positive Experiences|Mean Difference (Final Values)|-20.7|||<|0.0001|TWO_SIDED|95.0|-27.2|-14.3||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-14.3|-27.2|<.0001
70938178|NCT01307800|141376447|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|2.62||0.983|TWO_SIDED|95.0|-5.21|5.1||The comparison between 80 mg LY2140023, BID and placebo for the change from baseline in EQ-5D Questionnaire (VAS) was 2-sided without adjustment for multiplicity.|ANCOVA|||||5.10|-5.21|0.983
71065327|NCT01737710|141639770|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.02||||0.177|TWO_SIDED|95.0|0.75|5.71||Null hypothesis: no difference in the percentage of participants that were seroprotected against influenza H3N2 at Day 28 between the two groups.|Fisher Exact|||||5.71|0.75|0.177
71065328|NCT01737710|141639771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25||||0.092|TWO_SIDED|95.0|0.96|1.61||Null hypothesis: the fold differences in geometric mean titers against influenza B are not different between the two groups.|ANCOVA|||||1.61|0.96|0.092
71065329|NCT01737710|141639772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.103|TWO_SIDED|95.0|0.32|1.11||Null hypothesis: the fold differences in geometric mean titers against influenza H1N1 are not different between the two groups.|ANCOVA|||||1.11|0.32|0.103
71065330|NCT01737710|141639773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04||||0.895|TWO_SIDED|95.0|0.6|1.8||Null hypothesis: the fold differences in geometric mean titers against influenza H3N2 are not different between the two groups.|ANCOVA|||||1.80|0.60|0.895
71065331|NCT01737710|141639774|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03|||>|0.999|TWO_SIDED|95.0|0.54|1.97||Null hypothesis: no difference in the percentage of participants that were seroprotected against influenza B at Day 28 between the two groups.|Fisher Exact|||||1.97|0.54|>0.999
71065332|NCT01737710|141639775|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.253|TWO_SIDED|95.0|0.09|1.63||Null hypothesis: no difference in the percentage of participants that were seroprotected against influenza H1N1 at Day 28 between the two groups.|Fisher Exact|||||1.63|0.09|0.253
71065333|NCT01737710|141639776|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.218|TWO_SIDED|95.0|0.06|1.58||Null hypothesis: no difference in the percentage of participants that were seroprotected against influenza H3N2 at Day 28 between the two groups.|Fisher Exact|||||1.58|0.06|0.218
71065334|NCT01737710|141639777|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57||||0.14|TWO_SIDED|95.0|0.84|2.94||Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza B at Day 28 between the two groups.|Fisher Exact|||||2.94|0.84|0.140
71065335|NCT01737710|141639778|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.791|TWO_SIDED|95.0|0.24|2.65||Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza H1N1 at Day 28 between the two groups.|Fisher Exact|||||2.65|0.24|0.791
71065336|NCT01737710|141639779|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.833|TWO_SIDED|95.0|0.47|2.92||Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza H3N2 at Day 28 between the two groups.|Fisher Exact|||||2.92|0.47|0.833
71065337|NCT01737710|141639780|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.378|TWO_SIDED|95.0|0.4|1.38||Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza B at Day 28 between the two groups.|Fisher Exact|||||1.38|0.40|0.378
71111385|NCT03951766|141729291|SUPERIORITY|DBI - Negative Experiences|Mean Difference (Final Values)|-2.9||||0.27|TWO_SIDED|95.0|-8.1|2.3||"We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6."|t-test, 2 sided|||||2.3|-8.1|0.27
70938179|NCT01307800|141376447|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.56|STANDARD_ERROR_OF_MEAN|2.74||0.351|TWO_SIDED|95.0|-7.94|2.83||The comparison between 40 mg LY2140023, BID and placebo for the change from baseline in EQ-5D Questionnaire (VAS) was 2-sided without adjustment for multiplicity.|ANCOVA|||||2.83|-7.94|0.351
71065338|NCT01737710|141639781|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.783|TWO_SIDED|95.0|0.21|2.62||Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza H1N1 at Day 28 between the two groups.|Fisher Exact|||||2.62|0.21|0.783
71065339|NCT01737710|141639782|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.45||||0.143|TWO_SIDED|95.0|0.13|1.39|||Fisher Exact|Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza H3N2 at Day 28 between the two groups.||||1.39|0.13|0.143
71065340|NCT00942890|141639783|SUPERIORITY_OR_OTHER||Slope|0.9|STANDARD_ERROR_OF_MEAN|0.24|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
71065341|NCT00942890|141639789|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Regression, Linear|||||||<0.05
71065342|NCT04922255|141639795|SUPERIORITY|||||||0.04|||||||ANOVA|||||||0.04
71065343|NCT04922255|141639796|SUPERIORITY|||||||0.5|||||||Kruskal-Wallis|||||||0.50
71065344|NCT04922255|141639797|SUPERIORITY|||||||0.3|||||||ANOVA|||||||0.30
71065345|NCT04922255|141639798|SUPERIORITY|||||||0.7|||||||Chi-squared|||||||0.70
71065346|NCT04922255|141639799|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
71065347|NCT02677922|141639802|SUPERIORITY||Odds Ratio (OR)|4.86||||0.0003|TWO_SIDED|95.0|1.99|11.85|||Chi-squared|||||11.85|1.99|0.0003
71065348|NCT02677922|141639805|SUPERIORITY||Cox Proportional Hazard|0.59||||0.1083|TWO_SIDED|95.0|0.3|1.13|||Log Rank|||||1.13|0.30|0.1083
71065349|NCT02677922|141639807|SUPERIORITY||Odds Ratio (OR)|8.65|||<|0.001|TWO_SIDED|95.0|2.74|27.31|||Chi-squared|||||27.31|2.74|<0.001
71065350|NCT02677922|141639808|SUPERIORITY||Odds Ratio (OR)|1.77||||0.1943|TWO_SIDED|95.0|0.74|4.2|||Chi-squared|||||4.20|0.74|0.1943
71065351|NCT02677922|141639811|SUPERIORITY||Cox Proportional Hazard|0.99||||0.972|TWO_SIDED|95.0|0.52|1.87|||Log Rank|Unstratified log-rank test|Cox proportional hazards regression model|||1.87|0.52|0.9720
71065352|NCT02677922|141639812|OTHER|Confidence interval of difference|Difference|2.6|||||TWO_SIDED|95.0|-17.3|22.5|||||The CI for the difference was derived using Greenwood's variance estimate.|||22.5|-17.3|
71111386|NCT03951766|141729292|SUPERIORITY|Pros of Being Smoke-Free|Mean Difference (Final Values)|-9.1||||0.009|TWO_SIDED|95.0|-15.9|-2.3||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-2.3|-15.9|0.009
71065354|NCT02268916|141639853|SUPERIORITY|The study was powered based on a two-sample t-test of the primary outcomes, changes in physical activity or social participant over 6 months. Based on previous literature, in order to detect an effect size of 0.28 with at least 70% power, we aimed to recruit at least 35 participants in each treatment group.|Mean Difference (Final Values)|0.39|||=|0.18|TWO_SIDED|95.0|-0.18|0.97|||Mixed Models Analysis|The outcome was adjusted for time of visit, visit x intervention group, age, gender, body mass index, insulin, depression, and time-up-and-go score.||We hypothesized that at the end of 6 months, the intervention group will have increased physical activity as measured by CHAMPS compared to the control group.||0.97|-0.18|=0.18
71111387|NCT03951766|141729292|SUPERIORITY|Cons of Quitting|Mean Difference (Final Values)|-5.1||||0.25|TWO_SIDED|95.0|-13.7|3.6||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||3.6|-13.7|0.25
71111388|NCT03951766|141729293|SUPERIORITY|PSS total scores|Mean Difference (Final Values)|-2.4||||0.0069|TWO_SIDED|95.0|-4.1|-0.7||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-0.7|-4.1|0.0069
71111389|NCT03951766|141729293|SUPERIORITY|PSS - Perceived Helplessness|Mean Difference (Final Values)|-0.3||||0.0043|TWO_SIDED|95.0|-0.5|-0.1||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-0.1|-0.5|0.0043
71111390|NCT03951766|141729293|SUPERIORITY|PSS - Perceived Self-Efficacy|Mean Difference (Final Values)|0.1||||0.1953|TWO_SIDED|95.0|-0.1|0.4||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.4|-0.1|0.1953
71111391|NCT03951766|141729294|SUPERIORITY|Brief COPE Self-distraction|Mean Difference (Final Values)|0.4||||0.087|TWO_SIDED|95.0|-0.1|0.8||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.8|-0.1|0.087
71111392|NCT03951766|141729294|SUPERIORITY|Brief COPE active coping|Mean Difference (Final Values)|-0.209||||0.2866|TWO_SIDED|95.0|-0.6|0.2||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.2|-0.6|0.2866
71111393|NCT03951766|141729294|SUPERIORITY|Brief COPE denial|Mean Difference (Final Values)|0.0||||0.9296|TWO_SIDED|95.0|-0.4|0.4||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6|t-test, 2 sided|||||0.4|-0.4|0.9296
71111394|NCT03951766|141729294|SUPERIORITY|Brief COPE substance use|Mean Difference (Final Values)|-0.1||||0.6599|TWO_SIDED|95.0|-0.5|0.3||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6|t-test, 2 sided|||||0.3|-0.5|0.6599
71111395|NCT03951766|141729294|SUPERIORITY|Brief COPE use of emotional support|Mean Difference (Final Values)|0.3||||0.2315|TWO_SIDED|95.0|-0.2|0.7||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6|t-test, 2 sided|||||0.7|-0.2|0.2315
71111396|NCT03951766|141729294|SUPERIORITY|Brief COPE use of instrumental support|Mean Difference (Final Values)|0.1||||0.6183|TWO_SIDED|95.0|-0.3|0.6||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.6|-0.3|0.6183
71111397|NCT03951766|141729294|SUPERIORITY|Brief COPE behavioral disengagement|Mean Difference (Final Values)|0.3||||0.2037|TWO_SIDED|95.0|-0.1|0.7||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.7|-0.1|0.2037
71111398|NCT03951766|141729294|SUPERIORITY|Brief COPE venting|Mean Difference (Final Values)|-0.5||||0.006|TWO_SIDED|95.0|-0.9|-0.2||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-0.2|-0.9|0.0060
71111399|NCT03951766|141729294|SUPERIORITY|Brief COPE positive reframing|Mean Difference (Final Values)|-0.2||||0.3045|TWO_SIDED|95.0|-0.7|0.2||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.2|-0.7|0.3045
71111400|NCT03951766|141729294|SUPERIORITY|Brief COPE planning|Mean Difference (Final Values)|-0.6||||0.0029|TWO_SIDED|95.0|-1.0|-0.2||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-0.2|-1.0|0.0029
71111401|NCT03951766|141729294|SUPERIORITY|Brief COPE humor|Mean Difference (Final Values)|0.0||||0.8274|TWO_SIDED|95.0|-0.5|0.4||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.4|-0.5|0.8274
71111402|NCT03951766|141729294|SUPERIORITY|Brief COPE acceptance|Mean Difference (Final Values)|0.4||||0.0349|TWO_SIDED|95.0|0.0|0.9||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.9|0.0|0.0349
71065355|NCT02268916|141639854|SUPERIORITY||Slope|-2.2||||0.19|TWO_SIDED|95.0|-5.45|1.06|||Mixed Models Analysis|||We hypothesized that at the end of 6 months, intervention group will have improved participation as measured by satisfaction with participation in social roles.||1.06|-5.45|0.19
71065356|NCT02268916|141639854|SUPERIORITY||Slope|-1.02||||0.57|TWO_SIDED|95.0|-4.53|2.48|||Mixed Models Analysis|||We hypothesized that at the end of 6 months, intervention group will have improved participation as measured by satisfaction with participation in discretionary social activities.||2.48|-4.53|0.57
71065357|NCT02268916|141639854|SUPERIORITY||Slope|-2.44||||0.12|TWO_SIDED|95.0|-5.52|0.63|||Mixed Models Analysis|||We hypothesized that at the end of 6 months, intervention group will have improved participation as measured by the survey on the ability to participate in social roles and activities.||0.63|-5.52|0.12
71111403|NCT03951766|141729294|SUPERIORITY|Brief COPE religion|Mean Difference (Final Values)|0.2||||0.3451|TWO_SIDED|95.0|-0.2|0.6||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.6|-0.2|0.3451
70938180|NCT01307800|141376447|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.12|STANDARD_ERROR_OF_MEAN|2.54||0.403|TWO_SIDED|95.0|-2.86|7.11||The comparison between 10 mg LY2140023, BID and placebo for the change from baseline in EQ-5D Questionnaire (VAS) was 2-sided without adjustment for multiplicity.|ANCOVA|||||7.11|-2.86|0.403
70938181|NCT01307800|141376450|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-5.6|STANDARD_ERROR_OF_MEAN|2.4||0.021|TWO_SIDED|95.0|-10.4|-0.8||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||-0.8|-10.4|0.021
70938182|NCT01307800|141376450|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.8|STANDARD_ERROR_OF_MEAN|2.6||0.487|TWO_SIDED|95.0|-3.3|6.9||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||6.9|-3.3|0.487
71065358|NCT02268916|141639855|SUPERIORITY||Slope|-1.99|||<|0.05|TWO_SIDED|95.0|-3.97|-0.02|||Mixed Models Analysis|||We hypothesized that at 6-month follow-up, the intervention group will have better performance than the control group in timed up and go test.||-0.02|-3.97|<0.05
71111404|NCT03951766|141729294|SUPERIORITY|Brief COPE self-blame|Mean Difference (Final Values)|-0.8||||0.0006|TWO_SIDED|95.0|-1.2|-0.3||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-0.3|-1.2|0.0006
71111405|NCT03579693|141729334|SUPERIORITY||Mean Difference (Final Values)|0.44||||0.33|TWO_SIDED|95.0|-0.43|1.31|||Mixed Models Analysis||Interpretation of mean difference is for a typical participant, i.e. random effect of 0.|||1.31|-0.43|0.33
71111406|NCT03579693|141729334|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.93|TWO_SIDED|95.0|-0.9|0.82|||Mixed Models Analysis||Interpretation of mean difference is for a typical participant, i.e. random effect of 0.|||0.82|-0.90|0.93
70938183|NCT01307800|141376450|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|2.4||0.693|TWO_SIDED|95.0|-5.6|3.7||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||3.7|-5.6|0.693
70938184|NCT01307800|141376451|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.661|TWO_SIDED|95.0|-0.1|0.06||The comparison between 80 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.06|-0.10|0.661
70938185|NCT01307800|141376451|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.04||0.201|TWO_SIDED|95.0|-0.14|0.03||The comparison between 40 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.03|-0.14|0.201
70938186|NCT01307800|141376451|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.697|TWO_SIDED|95.0|-0.09|0.06||The comparison between 10 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.06|-0.09|0.697
71111407|NCT03579693|141729335|SUPERIORITY||Mean Difference (Final Values)|-1.76||||0.05|TWO_SIDED|95.0|-3.47|0.0|||Mixed Models Analysis||Interpretation of mean difference is for a typical participant, i.e. random effect of 0.|||0.00|-3.47|0.050
71111408|NCT03579693|141729335|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.47|TWO_SIDED|95.0|-2.28|1.05|||Mixed Models Analysis||Interpretation of mean difference is for a typical participant, i.e. random effect of 0.|||1.05|-2.28|0.47
70938187|NCT01307800|141376452|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.13||0.694|TWO_SIDED|95.0|-0.2|0.31||The comparison between 80 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.31|-0.20|0.694
71065359|NCT02268916|141639856|SUPERIORITY||Slope|0.11||||0.02|TWO_SIDED|95.0|0.02|0.2|||Mixed Models Analysis|||We hypothesized that at 6-month follow-up, the intervention group will have better performance than the control group in gait speed.||0.20|0.02|0.02
71065360|NCT02268916|141639857|SUPERIORITY||Slope|40.04||||0.02|TWO_SIDED|95.0|7.9|72.17|||Mixed Models Analysis|||We hypothesized that at 6-month follow-up, the intervention group will have better performance than the control group in six-minute walk test.||72.17|7.90|0.02
71065361|NCT00460811|141639890|SUPERIORITY_OR_OTHER|||||||0.0002|||||||ANCOVA|||For each of the 4 active linaclotide groups, the null hypothesis was that there was no difference between placebo and the dose group in the change from baseline in the weekly normalized CSBM Rate. An observed cases (OC) approach to missing post-baseline data was applied: any missing data were not imputed.||||0.0002
71065362|NCT00460811|141639890|SUPERIORITY_OR_OTHER|||||||0.0036||95.0|||||ANCOVA|||For each of the 4 active linaclotide groups, the null hypothesis was that there was no difference between placebo and the dose group in the change from baseline in the weekly normalized CSBM Rate. An observed cases (OC) approach to missing post-baseline data was applied: any missing data were not imputed.||||0.0036
71065363|NCT00460811|141639890|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||For each of the 4 active linaclotide groups, the null hypothesis was that there was no difference between placebo and the dose group in the change from baseline in the weekly normalized CSBM Rate. An observed cases (OC) approach to missing post-baseline data was applied: any missing data were not imputed.||||<0.0001
71065364|NCT00460811|141639890|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||ANCOVA|||For each of the 4 active linaclotide groups, the null hypothesis was that there was no difference between placebo and the dose group in the change from baseline in the weekly normalized CSBM Rate. An observed cases (OC) approach to missing post-baseline data was applied: any missing data were not imputed.||||0.0008
71065365|NCT02748356|141639897|OTHER|1 sample t-test|||||=|0.351|||||||t-test, 2 sided|This is a single group comparison||||||=0.351
71065366|NCT03515811|141639903|OTHER||Percentage and confidence interval|10.6|||||TWO_SIDED|95.0|5.0|19.2|||||95% CI: 5.0%-19.2%|||19.2|5.0|
71065367|NCT03515811|141639903|OTHER||Percentage and confidence interval|0.0|||||TWO_SIDED|95.0|0.0|7.0|||||95% CI: 0.0%-7.0%|||7.0|0.0|
71065368|NCT03515811|141639904|OTHER||Percentage and confidence interval|6.6|||||TWO_SIDED|95.0|3.1|12.2|||||95% CI: 3.1%-12.2%|||12.2|3.1|
71065369|NCT05870371|141639944|OTHER||Mean Difference (Net)|0.37|||=|0.002|TWO_SIDED|||||The above p value corresponds to the Mastoid Process left algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Mastoid Process left algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.002
71065370|NCT05870371|141639944|OTHER||Mean Difference (Net)|0.28|||=|0.018|TWO_SIDED|||||The above p value corresponds to the Mastoid Process right algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Mastoid Process right algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.018
71065371|NCT05870371|141639944|OTHER||Mean Difference (Net)|0.32|||=|0.02|TWO_SIDED|||||The above p value corresponds to the Bladder 10 left (BL 10) algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Bladder 10 left (BL 10) algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.020
71117655|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
71065372|NCT05870371|141639944|OTHER||Mean Difference (Net)|0.39|||=|0.025|TWO_SIDED|||||The above p value corresponds to the Bladder 10 right (BL 10) algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Bladder 10 right (BL 10) algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.025
71065373|NCT05870371|141639944|OTHER||Mean Difference (Net)|0.55|||<|0.001|TWO_SIDED|||||The above p value corresponds to the Zygapophyseal Joint left algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Zygapophyseal Joint left algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||<0.001
71065374|NCT05870371|141639944|OTHER||Mean Difference (Net)|0.57|||<|0.001|TWO_SIDED|||||The above p value corresponds to the Zygapophyseal Joint right algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Zygapophyseal Joint right algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||<0.001
71065375|NCT05870371|141639944|OTHER||Mean Difference (Net)|0.36|||=|0.139|TWO_SIDED|||||The above p value corresponds to the Upper Trapezius Muscle left algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Upper Trapezius Muscle left algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.139
71065376|NCT05870371|141639944|OTHER||Mean Difference (Net)|0.3|||=|0.011|TWO_SIDED|||||The above p value corresponds to the Upper Trapezius Muscle right algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Upper Trapezius Muscle right algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.011
71065377|NCT05870371|141639944|OTHER||Mean Difference (Net)|0.67|||=|0.01|TWO_SIDED|||||The above p value corresponds to the Levator Scapulae Muscle left algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Levator Scapulae Muscle left algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.010
70938188|NCT01307800|141376452|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.596|TWO_SIDED|95.0|-0.34|0.2||The comparison between 40 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.20|-0.34|0.596
70938189|NCT01307800|141376452|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.13||0.055|TWO_SIDED|95.0|0.0|0.49||The comparison between 10 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.49|0.00|0.055
70938190|NCT01307800|141376453|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.14||0.929|TWO_SIDED|95.0|-0.27|0.29||The comparison between 80 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.29|-0.27|0.929
70938191|NCT01307800|141376453|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.15||0.519|TWO_SIDED|95.0|-0.19|0.38||The comparison between 40 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.38|-0.19|0.519
70938192|NCT01307800|141376453|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.13|STANDARD_ERROR_OF_MEAN|0.14||0.323|TWO_SIDED|95.0|-0.13|0.4||The comparison between 10 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.40|-0.13|0.323
70938193|NCT01307800|141376454|SUPERIORITY_OR_OTHER_LEGACY|||||||0.758||95.0||||The comparison between 80 mg LY2140023, BID and placebo in the percentage of participants with a change from baseline in C-SSRS suicidal ideation was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Fisher Exact|||||||0.758
71065378|NCT05870371|141639944|OTHER||Mean Difference (Net)|0.62|||=|0.06|TWO_SIDED|||||The above p value corresponds to the Levator Scapulae Muscle right algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Levator Scapulae Muscle right algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.06
71065379|NCT05870371|141639944|OTHER||Mean Difference (Net)|0.51|||=|0.05|TWO_SIDED|||||The above p value corresponds to the Deltoid Muscle left algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Deltoid Muscle left algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.050
71065380|NCT05870371|141639944|OTHER||Mean Difference (Net)|0.41|||=|0.068|TWO_SIDED|||||The above p value corresponds to the Deltoid Muscle right algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Deltoid Muscle right algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.068
71065381|NCT05870371|141639944|OTHER||Mean Difference (Net)|0.59|||=|0.049|TWO_SIDED|||||The above p value corresponds to the Tibialis Anterior Muscle left algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Tibialis Anterior Muscle left algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.049
71065382|NCT05870371|141639944|OTHER||Mean Difference (Net)|0.73|||=|0.004|TWO_SIDED|||||The above p value corresponds to the Tibialis Anterior Muscle right algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Tibialis Anterior Muscle right algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.004
71117656|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
70938194|NCT01307800|141376454|SUPERIORITY_OR_OTHER_LEGACY|||||||0.576||95.0||||The comparison between 40 mg LY2140023, BID and placebo in the percentage of participants with a change from baseline in C-SSRS suicidal ideation was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Fisher Exact|||||||0.576
70938195|NCT01307800|141376454|SUPERIORITY_OR_OTHER_LEGACY|||||||0.425||95.0||||The comparison between 10 mg LY2140023, BID and placebo in the percentage of participants with a change from baseline in C-SSRS suicidal ideation was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Fisher Exact|||||||0.425
70938196|NCT01307800|141376457|SUPERIORITY_OR_OTHER_LEGACY|||||||0.444||95.0||||The comparison between 80 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|ANOVA|Analysis of variance (ANOVA) model on rank-transformed change.||||||0.444
71065383|NCT05870371|141639944|OTHER||Dependence coefficient (β)|-0.03|STANDARD_ERROR_OF_MEAN|0.03|=|0.297|TWO_SIDED|||||The above p value corresponds to the Mastoid Process left algometric site. The threshold for statistical significance was p \< 0.05. The above value correspond to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Mastoid Process left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.297
70938197|NCT01307800|141376457|SUPERIORITY_OR_OTHER_LEGACY|||||||0.799||95.0||||The comparison between 40 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|ANOVA|ANOVA model on rank-transformed change.||||||0.799
71111409|NCT00295646|141729336|SUPERIORITY|A two-sided significance level of 2.5% was used in this 2x2 factorial design of two primary endpoints according to the Bonferroni-Holm adjustment to control multiplicity.|Cox Proportional Hazard|1.1||||0.59|TWO_SIDED|95.0|0.78|1.53||Two-sided significance level of 2.5%, with the application of the Bonferroni-Holm adjustment for multiple comparisons|Log Rank||From the Cox Proportional hazard model with endocrine treatment fitted as a covariate. A hazard ratio \> 1.0 indicates a higher average event rate and a shorter disease-free time for arimidex relative to tamoxifen.|To determine the effect of arimidex (AZ and AC) compared to tamoxifen (TZ and TC) in terms of disease-free survival. Disease-free survival (DFS) is defined as the time from randomization to the first occurrence of a local or regional recurrence, cancer in the contralateral breast, distant metastasis, second primary carcinoma, or death from any cause.||1.53|0.78|0.59
71111410|NCT00295646|141729337|SUPERIORITY|A two-sided significance level of 2.5% was used in this 2x2 factorial design of two primary endpoints according to the Bonferroni-Holm adjustment to control multiplicity.|Cox Proportional Hazard|0.64||||0.01|TWO_SIDED|95.0|0.46|0.91||Two-sided significance level of 2.5%, with the application of the Bonferroni-Holm adjustment for multiple comparisons|Log Rank||From the Cox Proportional hazard model with Zoledronic Acid treatment fitted as a covariate. A hazard ratio \< 1.0 indicates a lower average event rate and a longer disease-free time for Zoledronic Acid relative to no Zoledronic Acid.|To determine the effect of Zoledronic Acid (AZ and TZ) compared to no Zoledronic Acid (AC and TC) in terms of disease-free survival. Disease-free survival (DFS) is defined as the time from randomization to the first occurrence of a local or regional recurrence, cancer in the contralateral breast, distant metastasis, second primary carcinoma, or death from any cause.||0.91|0.46|0.01
71065384|NCT05870371|141639944|OTHER||Dependence coefficient (β)|-0.004|STANDARD_ERROR_OF_MEAN|0.03|=|0.855|TWO_SIDED|||||The above p value corresponds to the Mastoid Process right algometric site. The threshold for statistical significance was p \< 0.05. The above value correspond to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Mastoid Process right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.855
71065385|NCT05870371|141639944|OTHER||Dependence coefficient (β)|-0.01|STANDARD_ERROR_OF_MEAN|0.02|=|0.594|TWO_SIDED|||||The above p value corresponds to the Bladder 10 (BL 10) left algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Bladder 10 (BL 10) left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.594
71065386|NCT05870371|141639944|OTHER||Dependence coefficient (β)|0.002|STANDARD_ERROR_OF_MEAN|0.02|=|0.929|TWO_SIDED|||||The above p value corresponds to the Bladder 10 (BL 10) right algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Bladder 10 (BL 10) right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.929
71065387|NCT05870371|141639944|OTHER||Dependence coefficient (β)|0.002|STANDARD_ERROR_OF_MEAN|0.05|=|0.725|TWO_SIDED|||||The above p value corresponds to the Zygapophyseal Joint left algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Zygapophyseal Joint left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.725
71065388|NCT05870371|141639944|OTHER||Dependence coefficient (β)|-0.01|STANDARD_ERROR_OF_MEAN|0.02|=|0.725|TWO_SIDED|||||The above p value corresponds to the Zygapophyseal Joint right algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Zygapophyseal Joint right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.725
71065389|NCT05870371|141639944|OTHER||Dependence coefficient (β)|0.02|STANDARD_ERROR_OF_MEAN|0.03|=|0.398|TWO_SIDED|||||The above p value corresponds to the Upper Trapezius Muscle left algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Upper Trapezius Muscle left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.398
71065390|NCT05870371|141639944|OTHER||Dependence coefficient (β)|0.04|STANDARD_ERROR_OF_MEAN|0.03|=|0.186|TWO_SIDED|||||The above p value corresponds to the Mastoid Process right algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Upper Trapezius Muscle right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.186
71065391|NCT05870371|141639944|OTHER||Dependence coefficient (β)|0.01|STANDARD_ERROR_OF_MEAN|0.02|=|0.833|TWO_SIDED|||||The above p value corresponds to the Levator Scapulae Muscle left algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Levator Scapulae Muscle left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.833
71065392|NCT05870371|141639944|OTHER||Dependence coefficient (β)|-0.02|STANDARD_ERROR_OF_MEAN|0.03|=|0.469|TWO_SIDED|||||The above p value corresponds to the Levator Scapulae Muscle right algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Levator Scapulae Muscle right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.469
71065393|NCT05870371|141639944|OTHER||Dependence coefficient (β)|-0.02|STANDARD_ERROR_OF_MEAN|0.03|=|0.399|TWO_SIDED|||||The above p value corresponds to the Deltoid Muscle left algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Deltoid Muscle left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.399
71065394|NCT05870371|141639944|OTHER||Dependence coefficient (β)|-0.01|STANDARD_ERROR_OF_MEAN|0.02|=|0.752|TWO_SIDED|||||The above p value corresponds to the Deltoid Muscle right algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Deltoid Muscle right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.752
71065395|NCT05870371|141639944|OTHER||Dependence coefficient (β)|-0.07|STANDARD_ERROR_OF_MEAN|0.02|=|0.002|TWO_SIDED|||||The above p value corresponds to the Tibialis Anterior Muscle left algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Tibialis Anterior Muscle left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.002
71065396|NCT05870371|141639944|OTHER||Dependence coefficient (β)|-0.07|STANDARD_ERROR_OF_MEAN|0.02|=|0.003|TWO_SIDED|||||The above p value corresponds to the Tibialis Anterior Muscle right algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Tibialis Anterior Muscle right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.003
71065397|NCT05870371|141639945|OTHER||Mean Difference (Net)|5.41|||=|0.002|TWO_SIDED|||||The above p value corresponds to the Rotation maximum. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Rotation maximum.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||=0.002
71078574|NCT05206734|141665034|OTHER||Risk Ratio (RR)|1.82|||||TWO_SIDED|95.0|1.33|2.52|||||RR calculated using negative binomial model adjusted for age,sex,socioeconomic status,ethnicity,IBD type and comorbidities.Reflects a comparison of the incidence rate ratio between IBD participants diagnosed with and without mental health conditions.|||2.52|1.33|
70938198|NCT01307800|141376457|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073||95.0||||The comparison between 10 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|ANOVA|ANOVA model on rank-transformed change.||||||0.073
71111411|NCT00295646|141729338|SUPERIORITY|No multiplicity adjustment was applied.|Cox Proportional Hazard|1.11||||0.53|TWO_SIDED|95.0|0.8|1.56|||Log Rank||From the Cox Proportional hazard model with endocrine treatment fitted as a covariate. A hazard ratio \> 1.0 indicates a higher average event rate and a shorter recurrence-free time for arimidex relative to tamoxifen.|To determine the effect of arimidex (AZ and AC) compared to tamoxifen (TZ and TC) in terms of recurrence-free survival. Recurrence-free survival is defined as the time from randomization to the first occurrence of a local or regional recurrence, cancer in the contralateral breast, distant metastasis, second primary carcinoma, or death related to breast cancer.||1.56|0.80|0.53
71117657|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
71117658|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
70852666|NCT01578850|141194327|SUPERIORITY_OR_OTHER||Difference in proportions|27.2|||<|0.001|TWO_SIDED|95.0|17.38|36.93|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 52||36.93|17.38|<0.001
71117659|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
71117660|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
71117661|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
71117662|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
71117663|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
71117664|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
71117665|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
71117666|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
71117667|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
71117668|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
71065398|NCT05870371|141639945|OTHER||Mean Difference (Net)|4.92|||=|0.046|TWO_SIDED|||||The above p value corresponds to the Rotation average. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Rotation average.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||=0.046
71065399|NCT05870371|141639945|OTHER||Mean Difference (Net)|3.81|||<|0.001|TWO_SIDED|||||The above p value corresponds to the Lateral Flexion maximum. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Lateral Flexion maximum.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||<0.001
70938199|NCT01307800|141376458|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.46||0.761|TWO_SIDED|95.0|-0.76|1.04||The comparison between 80 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||1.04|-0.76|0.761
71065400|NCT05870371|141639945|OTHER||Mean Difference (Net)|3.57|||=|0.043|TWO_SIDED|||||The above p value corresponds to the Lateral Flexion average. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Lateral Flexion average.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||=0.043
71065401|NCT05870371|141639945|OTHER||Mean Difference (Net)|4.52|||=|0.018|TWO_SIDED|||||The above p value corresponds to the Flexion maximum. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Flexion maximum.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||=0.018
71111412|NCT00295646|141729339|SUPERIORITY|No multiplicity adjustment was applied.|Cox Proportional Hazard|0.65||||0.01|TWO_SIDED|95.0|0.46|0.92|||Log Rank|||To determine the effect of Zoledronic Acid (AZ and TZ) compared to no Zoledronic Acid (AC and TC) in terms of recurrence-free survival. Recurrence-free survival is defined as the time from randomization to the first occurrence of a local or regional recurrence, cancer in the contralateral breast, distant metastasis, second primary carcinoma, or death related to breast cancer.|From the Cox Proportional hazard model with Zoledronic Acid treatment fitted as a covariate. A hazard ratio \< 1.0 indicates a lower average event rate and a longer recurrence-free time for Zoledronic Acid relative to no Zoledronic Acid.|0.92|0.46|0.01
71111413|NCT00295646|141729340|SUPERIORITY|No multiplicity adjustment was applied.|Cox Proportional Hazard|1.8||||0.07|TWO_SIDED|95.0|0.96|3.38|||Log Rank||From the Cox Proportional hazard model with endocrine treatment fitted as a covariate. A hazard ratio \> 1.0 indicates a higher average event rate and a shorter survival time for arimidex relative to tamoxifen.|To determine the effect of anastrozole (AZ and AC) compared to tamoxifen (TZ and TC) in terms of overall survival. Overall survival is defined as the time from randomization to death from any cause.||3.38|0.96|0.07
71111414|NCT00295646|141729341|SUPERIORITY|No multiplicity adjustment was applied.|Cox Proportional Hazard|0.6||||0.1|TWO_SIDED|95.0|0.32|1.11|||Log Rank||From the Cox Proportional hazard model with Zoledronic Acid treatment fitted as a covariate. A hazard ratio \< 1.0 indicates a lower average event rate and a longer survival time for Zoledronic Acid relative to no Zoledronic Acid.|To determine the effect of Zoledronic Acid (AZ and TZ) compared to no Zoledronic Acid (AC and TC) in terms of overall survival. Overall survival is defined as the time from randomization to death from any cause.||1.11|0.32|0.10
71111415|NCT02626156|141729342|SUPERIORITY||Risk Difference (RD)|0.13|STANDARD_ERROR_OF_MEAN|0.07||0.091|TWO_SIDED|95.0|-0.02|0.3|||Chi-squared||Asymptotic standard error was used|||0.3|-0.02|0.091
71111416|NCT03083665|141729384|SUPERIORITY||Percent reduction over Placebo|24.5||||0.0005|TWO_SIDED|95.0|11.7|35.5||Statistical testing with control of Type I error rate were based on a Hochberg multiple comparison procedure.|ANCOVA||Based on ANCOVA with log-transformed \[log(x+1)\] Treatment Period 28-day adjusted partial seizure frequency.|||35.5|11.7|0.0005
71111417|NCT03083665|141729384|SUPERIORITY||Percent reduction over Placebo|33.4|||<|0.0001|TWO_SIDED|95.0|21.9|43.1||Statistical testing with control of Type I error rate were based on a Hochberg multiple comparison procedure.|ANCOVA||Based on ANCOVA with log-transformed \[log(x+1)\] Treatment Period 28-day adjusted partial seizure frequency.|||43.1|21.9|<0.0001
71111418|NCT01467466|141729394|SUPERIORITY||Odds Ratio (OR)|0.95||||0.7|TWO_SIDED|95.0|0.73|1.24|||Wald's Chi-Square|||||1.24|0.73|0.70
71111419|NCT01467466|141729395|SUPERIORITY||Odds Ratio (OR)|1.02||||0.86|TWO_SIDED|95.0|0.78|1.34|||Wald's Chi-Square|||||1.34|0.78|0.86
71111420|NCT02622295|141729396|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
71111421|NCT02622295|141729397|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
71111422|NCT02622295|141729398|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
71111423|NCT02622295|141729399|SUPERIORITY|||||||0.467|||||||ANOVA|||||||0.467
71111424|NCT02622295|141729400|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
71111425|NCT02622295|141729401|SUPERIORITY|||||||0.932|||||||ANOVA|||||||0.932
71111426|NCT02622295|141729402|SUPERIORITY|||||||0.326|||||||ANOVA|||||||0.326
71111427|NCT02622295|141729403|SUPERIORITY|||||||0.673|||||||ANOVA|||||||0.673
71111428|NCT02622295|141729404|SUPERIORITY|||||||0.539|||||||ANOVA|||||||0.539
71111429|NCT02622295|141729405|SUPERIORITY|||||||0.155|||||||ANOVA|||||||0.155
71111430|NCT02622295|141729406|SUPERIORITY|||||||0.164|||||||ANOVA|||||||0.164
71111431|NCT02622295|141729407|SUPERIORITY|||||||0.493|||||||ANOVA|||||||0.493
71111432|NCT02622295|141729408|SUPERIORITY|||||||0.458|||||||ANOVA|||||||0.458
71065402|NCT05870371|141639945|OTHER||Mean Difference (Net)|4.45|||=|0.102|TWO_SIDED|||||The above p value corresponds to the Flexion average. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Flexion average.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||=0.102
71065403|NCT05870371|141639945|OTHER||Mean Difference (Net)|5.85|||=|0.16|TWO_SIDED|||||The above p value corresponds to the Extension maximum. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Extension maximum.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||=0.160
71065404|NCT05870371|141639945|OTHER||Mean Difference (Net)|5.48|||<|0.039|TWO_SIDED|||||The above p value corresponds to the Extension average. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Extension average.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||<0.039
71065405|NCT05870371|141639945|OTHER||Dependence coefficient (β)|-5.0|STANDARD_ERROR_OF_MEAN|1.51|=|0.001|TWO_SIDED|||||The above p-value corresponds to the Rotation maximum. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Rotation maximum. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.001
71065406|NCT05870371|141639945|OTHER||Dependence coefficient (β)|-5.0|STANDARD_ERROR_OF_MEAN|1.51|=|0.002|TWO_SIDED||||||Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Rotation average. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.002
71065407|NCT05870371|141639945|OTHER||Dependence coefficient (β)|-4.84|STANDARD_ERROR_OF_MEAN|1.6|=|0.048|TWO_SIDED|||||The above p value corresponds to the Lateral Flexion maximum. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Lateral Flexion maximum. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.048
71065408|NCT05870371|141639945|OTHER||Dependence coefficient (β)|-2.0|STANDARD_ERROR_OF_MEAN|1.06|=|0.059|TWO_SIDED|||||The above p value corresponds to the Lateral Flexion average. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Lateral Flexion average. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.059
71065409|NCT05870371|141639945|OTHER||Dependence coefficient (β)|-0.92|STANDARD_ERROR_OF_MEAN|1.62|=|0.57|TWO_SIDED|||||The above p value corresponds to the Flexion maximum. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Flexion maximum. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.57
71065410|NCT05870371|141639945|OTHER||Dependence coefficient (β)|-0.14|STANDARD_ERROR_OF_MEAN|1.65|=|0.931|TWO_SIDED|||||The above p value corresponds to the Flexion average. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Flexion average. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.931
70938200|NCT01307800|141376458|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.47||0.761|TWO_SIDED|95.0|-0.78|1.06||The comparison between 40 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||1.06|-0.78|0.761
71078575|NCT05206734|141665035|OTHER||Hazard Ratio (HR)|1.63|||||TWO_SIDED|95.0|1.02|2.62|||||HR calculated using Cox regression models adjusted for age,sex,socioeconomic status,ethnicity,IBD type and comorbidities.Reflects a comparison of the incidence rate ratio between IBD participants diagnosed with and without mental health conditions.|||2.62|1.02|
71065411|NCT05870371|141639945|OTHER||Dependence coefficient (β)|-1.17|STANDARD_ERROR_OF_MEAN|1.99|=|0.558|TWO_SIDED|||||The above p value corresponds to the Extension maximum. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Extension maximum . The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.558
71065412|NCT05870371|141639945|OTHER||Dependence coefficient (β)|-0.03|STANDARD_ERROR_OF_MEAN|1.96|=|0.989|TWO_SIDED|||||The above p value corresponds to the Extension average. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Extension average. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.989
71065413|NCT05870371|141639946|OTHER||Mean Difference (Net)|1.37|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||Null hypothesis: The application of ATM does not affect the strength of deep neck flexor muscles as measured by the Chattanooga Stabilizer Pressure Biofeedback in patients with chronic pain in the cervical spine (secondary hypothesis).||||<0.001
71065414|NCT05870371|141639946|OTHER||Dependence coefficient (β)|0.01|STANDARD_ERROR_OF_MEAN|0.01|=|0.437|TWO_SIDED|||||The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of applying ATM does not differ in improving the strength of deep neck flexor muscles measured by the Chattanooga Stabilizer Pressure Biofeedback in patients with chronic neck pain than applying A-S (secondary hypothesis).||||=0.437
71065415|NCT05870371|141639947|OTHER||Mean Difference (Net)|0.02|||=|0.919|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||Null Hypothesis: The application of ATM does not affect the respiratory function assessed by the portable spirometer (MIR Spirodoc) in patients with chronic neck pain (secondary hypothesis).||||=0.919
71065416|NCT05870371|141639947|OTHER||Dependence coefficients (β)|-0.05|STANDARD_ERROR_OF_MEAN|0.02|=|0.01|TWO_SIDED|||||The above value corresponds to the comparison between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis||The above value corresponds to the comparison between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of the respiratory function in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.010
71065417|NCT05870371|141639948|OTHER||Mean Difference (Net)|0.09|||=|0.659|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||Null Hypothesis: The application of ATM does not affect the respiratory function assessed by the portable spirometer (MIR Spirodoc) in patients with chronic neck pain (secondary hypothesis).||||=0.659
71065418|NCT05870371|141639948|OTHER||Dependence coefficient (β)|-0.04|STANDARD_ERROR_OF_MEAN|0.02|=|0.05|TWO_SIDED|||||The above value correspond to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of the respiratory function in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.05
71078576|NCT05206734|141665036|OTHER||Risk Ratio (RR)|2.78|||||TWO_SIDED|95.0|1.76|4.43|||||RR calculated using negative binomial model adjusted for age,sex,socioeconomic status,ethnicity,IBD type and comorbidities.Reflects a comparison of the incidence rate ratio between IBD participants diagnosed with and without mental health conditions.|||4.43|1.76|
71078577|NCT05206734|141665038|OTHER||Risk Ratio (RR)|1.33|||||TWO_SIDED|95.0|1.12|1.58|||||RR calculated using negative binomial model adjusted for age,sex,socioeconomic status,ethnicity,IBD type and comorbidities.Reflects a comparison of the incidence rate ratio between IBD participants diagnosed with and without mental health conditions.|||1.58|1.12|
71078578|NCT05206734|141665039|OTHER||Risk Ratio (RR)|1.87|||||TWO_SIDED|95.0|1.29|2.75|||||RR calculated using negative binomial model adjusted for age,sex,socioeconomic status,ethnicity,IBD type and comorbidities.Reflects a comparison of the incidence rate ratio between IBD participants diagnosed with and without mental health conditions.|||2.75|1.29|
71078579|NCT02330172|141665042|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
71078580|NCT02330172|141665043|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
71078581|NCT00734656|141665044|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||t-test, 2 sided|||null hypothesis - dutasteride does not affect blood alcohol following standardized dose of alcohol (0.8 gr/kg)||||0.28
71078582|NCT00734656|141665045|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Mixed Models Analysis|||null hypothesis: dutasteride pre-treatment does not reduce the sedative effect of alcohol||||0.010
71078583|NCT00734656|141665046|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Mixed Models Analysis|||null hypothesis: dutasteride pre-treatment does not reduce the stimulating effect of alcohol||||0.17
70938201|NCT01307800|141376458|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.44||0.489|TWO_SIDED|95.0|-1.17|0.56||The comparison between 10 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.56|-1.17|0.489
71065419|NCT05870371|141639949|OTHER||Mean Difference (Net)|10.28|||=|0.09|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||Null Hypothesis: The application of ATM does not affect the respiratory function assessed by the portable spirometer (MIR Spirodoc) in patients with chronic neck pain (secondary hypothesis).||||=0.09
71065420|NCT05870371|141639949|OTHER||Dependence coefficient (β)|-0.06|STANDARD_ERROR_OF_MEAN|0.02|=|0.005|TWO_SIDED|||||The above value correspond to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of the respiratory function in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.005
71111433|NCT01144416|141729418|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pre-defined non-inferiority margin was -8%|Difference in percentage vital pregnancy|-3.0|||||TWO_SIDED|95.0|-7.4|1.4|||generalized linear model|The estimated difference in percentage vital pregnancy was adjusted for age class as stratified (≤38 yrs vs. \>38 yrs)||||1.4|-7.4|
71111434|NCT01144416|141729419|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pre-defined non-inferiority margin was -3 oocytes.|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-0.2|1.2|||ANOVA|The estimated difference in number of oocytes retrieved was adjusted for age class as stratified (≤38 yrs vs. \>38 yrs) and center.||||1.2|-0.2|
71111435|NCT01144416|141729420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pre-defined non-inferiority margin was -8%|Difference in Live Birth Rates|-2.3|||||TWO_SIDED|95.0|-6.5|1.9|||generalized linear model|The estimated difference in live birth rate was adjusted for age class as stratified (≤38 yrs vs. \>38 yrs)||||1.9|-6.5|
71111436|NCT01144416|141729421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3||95.0|||||Fisher Exact|||||||0.30
71111437|NCT01144416|141729422|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999||95.0|||||Fisher Exact|||||||>0.999
71111438|NCT03541499|141729441|SUPERIORITY|||||||0.807|||||||Barnard's exact test|||At any time point||||0.807
71111439|NCT03541499|141729441|SUPERIORITY|||||||0.043|||||||Barnard's exact test|||At any time point||||0.043
71111440|NCT03541499|141729442|SUPERIORITY|||||||1|||||||Barnard's exact test|||Any time point||||1.000
71111441|NCT03541499|141729442|SUPERIORITY|||||||0.301|||||||Barnard's exact test|||Any time point||||0.301
71111442|NCT03541499|141729443|SUPERIORITY|||||||1|||||||Barnard's exact test|||Any time point||||1.000
71065421|NCT05870371|141639950|OTHER||Mean Difference (Net)|-7.87|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Total McGill Score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Total McGill Score.|Null Hypothesis: The application of ATM does not affect the pain in the cervical spine in terms of its intensity and quality, i.e., its sensory, emotional and behavioral dimensions using the McGill Pain Questionnaire-short form (SFMPQ) in patients with chronic neck pain (secondary hypothesis).||||<0.001
71111443|NCT03541499|141729443|SUPERIORITY|||||||0.009|||||||Barnard's exact test|||Any time point||||0.009
71111444|NCT03541499|141729445|SUPERIORITY|||||||0.526|||||||Barnard's exact test|||IgA, any time point||||0.526
71111445|NCT03541499|141729445|SUPERIORITY|||||||0.1|||||||Barnard's exact test|||IgA, any time point||||0.100
71111446|NCT03541499|141729445|SUPERIORITY|||||||0.055|||||||Barnard's exact test|||IgG, any time point||||0.055
71111447|NCT03541499|141729445|SUPERIORITY|||||||0.023|||||||Barnard's exact test|||IgG, any time point||||0.023
71111448|NCT03541499|141729446|SUPERIORITY|||||||0.174|||||||Barnard's exact test|||IgA, any time point||||0.174
71111449|NCT03541499|141729446|SUPERIORITY|||||||0.006|||||||Barnard's exact test|||IgA, any time point||||0.006
71111450|NCT03541499|141729446|SUPERIORITY|||||||0.745|||||||Barnard's exact test|||IgG, any time point||||0.745
71111451|NCT03541499|141729446|SUPERIORITY|||||||0.023|||||||Barnard's exact test|||IgG, any time point||||0.023
71111452|NCT03541499|141729452|SUPERIORITY|||||||0.023|||||||Barnard's exact test|||IgA, any time point||||0.023
71111453|NCT03541499|141729452|SUPERIORITY|||||||0.142|||||||Barnard's exact test|||IgA, any time point||||0.142
71111454|NCT03541499|141729452|SUPERIORITY|||||||0.526|||||||Barnard's exact test|||IgG, any time point||||0.526
71111455|NCT03541499|141729452|SUPERIORITY|||||||0.142|||||||Barnard's exact test|||IgG, any time point||||0.142
71111456|NCT03541499|141729453|SUPERIORITY|||||||0.836|||||||Barnard's exact test|||IgA, any time point||||0.836
71111457|NCT03541499|141729453|SUPERIORITY|||||||1|||||||Barnard's exact test|||IgA, any time point||||1.000
71111458|NCT03541499|141729453|SUPERIORITY|||||||0.526|||||||Barnard's exact test|||IgG, any time point||||0.526
71111459|NCT03541499|141729453|SUPERIORITY|||||||0.119|||||||Barnard's exact test|||IgG, any time point||||0.119
71111460|NCT03541499|141729454|SUPERIORITY|||||||0.271|||||||Barnard's exact test|||Any time point||||0.271
71111461|NCT03541499|141729454|SUPERIORITY|||||||0.226|||||||Barnard's exact test|||Any time point||||0.226
71111462|NCT03541499|141729455|SUPERIORITY|||||||0.783|||||||Barnard's exact test|||Any time point||||0.783
71111463|NCT03541499|141729455|SUPERIORITY|||||||0.001|||||||Barnard's exact test|||Any time point||||0.001
71111464|NCT03541499|141729456|SUPERIORITY|||||||0.745|||||||Barnard's exact test|||Any time point||||0.745
71111465|NCT03541499|141729456|SUPERIORITY|||||||0.068|||||||Barnard's exact test|||Any time point||||0.068
71111466|NCT03541499|141729457|SUPERIORITY|||||||0.585|||||||Barnard's exact test|||Any time point||||0.585
71111467|NCT03541499|141729457|SUPERIORITY|||||||1|||||||Barnard's exact test|||Any time point||||1.000
71111468|NCT02131662|141729459|SUPERIORITY_OR_OTHER||Percentage difference|58.28|||||TWO_SIDED|95.0|44.55|70.94||||||The placebo-adjusted amenorrhea rate was summarized by dose with unconditional 2-sided 95% confidence intervals for each active treatment group. This unconditional confidence interval was calculated by inverting 2 separate one-sided tests of half the nominal significance level each.||70.94|44.55|
71065422|NCT05870371|141639950|OTHER||Mean Difference (Net)|-5.55|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Sensory Score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Sensory Score.|Null Hypothesis: The application of ATM does not affect the pain in the cervical spine in terms of its intensity and quality, i.e., its sensory, emotional and behavioral dimensions using the McGill Pain Questionnaire-short form (SFMPQ) in patients with chronic neck pain (secondary hypothesis).||||<0.001
71065423|NCT05870371|141639950|OTHER||Mean Difference (Net)|-2.33|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Affective Score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Affective Score.|Null Hypothesis: The application of ATM does not affect the pain in the cervical spine in terms of its intensity and quality, i.e., its sensory, emotional and behavioral dimensions using the McGill Pain Questionnaire-short form (SFMPQ) in patients with chronic neck pain (secondary hypothesis).||||<0.001
71065424|NCT05870371|141639950|OTHER||Dependence coefficient (β)|0.0|STANDARD_ERROR_OF_MEAN|0.05|=|0.996|TWO_SIDED|||||The above p-value corresponds to the Total McGill score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models. The above p-value corresponds to the comparison which is between groups at baseline.|The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the reduction of pain in terms of its intensity and quality in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.996
71065425|NCT05870371|141639950|OTHER||Dependence coefficient (β)|0.0|STANDARD_ERROR_OF_MEAN|0.05|=|0.968|TWO_SIDED|||||The above p-value corresponds to the Sensory Score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models. The above p-value corresponds to the comparison which is between groups at baseline.|The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the reduction of pain in terms of its intensity and quality in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.968
71065426|NCT05870371|141639950|OTHER||Dependence coefficient (β)|0.01|STANDARD_ERROR_OF_MEAN|0.05|=|0.854|TWO_SIDED|||||The above p-value corresponds to the Affective Score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models. The above p-value corresponds to the comparison which is between groups at baseline.|The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the reduction of pain in terms of its intensity and quality in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.854
71065427|NCT05870371|141639951|OTHER||Mean Difference (Net)|-2.59|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||||||<0.001
71065428|NCT05870371|141639951|OTHER||Dependence coefficient (β)|0.0|STANDARD_ERROR_OF_MEAN|0.03|=|0.952|TWO_SIDED|||||The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the comparison which is between groups at baseline.|||||=0.952
71065429|NCT05870371|141639952|OTHER||Mean Difference (Net)|-1.06|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|Log transformation was used for the mixed linear models.||||||<0.001
71065430|NCT05870371|141639952|OTHER||Dependence coefficient (β)|0.0|STANDARD_ERROR_OF_MEAN|0.02|=|0.989|TWO_SIDED|||||The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the comparison which is between groups at baseline.|||||=0.989
71111469|NCT02131662|141729459|SUPERIORITY_OR_OTHER||Percentage difference|52.37|||||TWO_SIDED|95.0|38.8|65.42||||||The placebo-adjusted amenorrhea rate was summarized by dose with unconditional 2-sided 95% confidence intervals for each active treatment group. This unconditional confidence interval was calculated by inverting 2 separate one-sided tests of half the nominal significance level each.||65.42|38.8|
71111470|NCT02131662|141729459|SUPERIORITY_OR_OTHER||Percentage difference|54.01|||||TWO_SIDED|95.0|40.41|66.95||||||The placebo-adjusted amenorrhea rate was summarized by dose with unconditional 2-sided 95% confidence intervals for each active treatment group. This unconditional confidence interval was calculated by inverting 2 separate one-sided tests of half the nominal significance level each.||66.95|40.41|
71065431|NCT05870371|141639953|OTHER||Mean Difference (Net)|-5.6|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||Null Hypothesis: The application of ATM does not affect the functionality recorded with the Neck Disability Index (NDI) in patients with chronic pain in the cervical spine (secondary hypothesis).||||<0.001
71065432|NCT05870371|141639953|OTHER||Dependence coefficient (β)|0.0|STANDARD_ERROR_OF_MEAN|0.03|=|0.973|TWO_SIDED|||||The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of functionality recorded with the Neck Disability Index (NDI) in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.973
71065433|NCT05870371|141639954|OTHER||Mean Difference (Net)|-2.11|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Depression subscale of HADS. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|Log transformation was used for the mixed linear models.|The above value corresponds to the Depression subscale of HADS.|Null Hypothesis: The application of ATM does not affect the anxiety and depression captured by the Hospital Anxiety \& Depression Scale (HADS) in patients with chronic neck pain (secondary hypothesis).||||<0.001
71111471|NCT02131662|141729459|SUPERIORITY_OR_OTHER||Percentage difference|28.28|||||TWO_SIDED|95.0|15.92|41.5||||||The placebo-adjusted amenorrhea rate was summarized by dose with unconditional 2-sided 95% confidence intervals for each active treatment group. This unconditional confidence interval was calculated by inverting 2 separate one-sided tests of half the nominal significance level each.||41.5|15.92|
71065434|NCT05870371|141639954|OTHER||Mean Difference (Net)|-2.05|||<|0.001|TWO_SIDED|||||The above value corresponds to the Anxiety subscale of HADS. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|Log transformation was used for the mixed linear models.|The above value corresponds to the Anxiety subscale of HADS.|Null Hypothesis: The application of ATM does not affect the anxiety and depression captured by the Hospital Anxiety \& Depression Scale (HADS) in patients with chronic neck pain (secondary hypothesis).||||<0.001
71065435|NCT05870371|141639954|OTHER||Dependence coefficient (β)|0.04|STANDARD_ERROR_OF_MEAN|0.04|=|0.305|TWO_SIDED|||||The above p-value corresponds to the Depression subscale of HADS. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Depression subscale of HADS. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the reduction of anxiety and depression captured by the Hospital Anxiety \& Depression Scale (HADS) in patients with chronic pain in the cervical spine from the application of A-S (secondary hypothesis).||||=0.305
71065436|NCT05870371|141639954|OTHER||Dependence coefficient (β)|0.05|STANDARD_ERROR_OF_MEAN|0.03|=|0.137|TWO_SIDED|||||The above p-value corresponds to the Anxiety subscale of HADS. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|Log transformation was used for the mixed linear models.|The above values correspond to the Anxiety subscale of HADS. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the reduction of anxiety and depression captured by the Hospital Anxiety \& Depression Scale (HADS) in patients with chronic pain in the cervical spine from the application of A-S (secondary hypothesis).||||=0.137
71065437|NCT05870371|141639955|OTHER||Mean Difference (Net)|-3.82|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||Null Hypothesis: The application of ATM does not affect the kinesiophobia as measured by the Tampa Scale Kinesiophobia (TSK\_GR) in patients with chronic neck pain (secondary hypothesis).||||<0.001
71065438|NCT05870371|141639955|OTHER||Dependence coefficient (β)|0.02|STANDARD_ERROR_OF_MEAN|0.01|=|0.151|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ from the application of A-S in reducing kinesiophobia measured by the Tampa Scale Kinesiophobia (TSK\_GR) in patients with chronic neck pain (secondary hypothesis).||||=0.151
71065439|NCT05870371|141639955|OTHER||||||=|0.021||||||The threshold for statistical significance was p \< 0.05.|McNemar|||||||=0.021
71065440|NCT05870371|141639956|OTHER||Mean Difference (Net)|-4.24|||=|0.006|TWO_SIDED|||||The above p-value corresponds to the FABQ\_physical subscale. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the FABQ\_physical subscale.|Null Hypothesis: The application of ATM does not affect the perception of the fear and the effort to avoid pain in relation to physical and work activities assessed by the Fear Avoidance Beliefs Questionnaire\_Greek version (FABQ\_GR) in patients with chronic neck pain (secondary hypothesis).||||=0.006
71065441|NCT05870371|141639956|OTHER||Mean Difference (Net)|-2.24|||=|0.001|TWO_SIDED|||||The above p-value corresponds to the FABQ\_work subscale. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the FABQ\_work subscale.|Null Hypothesis: The application of ATM does not affect the perception of the fear and the effort to avoid pain in relation to physical and work activities assessed by the Fear Avoidance Beliefs Questionnaire\_Greek version (FABQ\_GR) in patients with chronic neck pain (secondary hypothesis).||||=0.001
71065442|NCT05870371|141639956|OTHER||Dependence coefficient (β)|0.1|STANDARD_ERROR_OF_MEAN|0.07|=|0.197|TWO_SIDED|||||The above p-value corresponds to the FABQ\_work subscale. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the FABQ\_work subscale. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of perception of fear and effort to avoid pain in relation to physical and work activities assessed by the Fear Avoidance Beliefs Questionnaire\_Greek version (FABQ\_GR) in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.197
70938202|NCT00689351|141376471|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.77|||||TWO_SIDED|95.0|0.62|0.97|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 4: Ratio of geometric means (13vPnC, 7vPnC)||0.97|0.62|
71078584|NCT00734656|141665047|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||null hypothesis - A single 4 mg dose of dutasteride does not reduce serum 3a-androstanediol glucuronide levels||||<0.001
71078585|NCT01088711|141665052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|90.76|||||TWO_SIDED|90.0|82.7|99.37|||Difference in geometric means (GMs)|||||99.37|82.70|
71078586|NCT01088711|141665054|SUPERIORITY_OR_OTHER||Ratio of geometric least-squares means|1.92|||||TWO_SIDED|90.0|1.55|2.38|||||GMR is ratio of active GLP-1 levels in omarigliptin:placebo groups.|||2.38|1.55|
71078587|NCT01088711|141665055|SUPERIORITY_OR_OTHER||Ratio of geometric least-squares means|0.91|||||TWO_SIDED|90.0|0.72|1.17|||||GMR is ratio of total GLP-1 levels in omarigliptin:placebo groups.|||1.17|0.72|
70938203|NCT00689351|141376471|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.17|||||TWO_SIDED|95.0|0.87|1.57|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 6B: Ratio of geometric means (13vPnC, 7vPnC)||1.57|0.87|
71065443|NCT05870371|141639956|OTHER||Dependence coefficient (β)|0.07|STANDARD_ERROR_OF_MEAN|0.04|=|0.066|TWO_SIDED|||||The above p-value corresponds to the FABQ\_physical subscale. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the FABQ\_physical subscale. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of perception of fear and effort to avoid pain in relation to physical and work activities assessed by the Fear Avoidance Beliefs Questionnaire\_Greek version (FABQ\_GR) in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.066
71065444|NCT05870371|141639957|OTHER||Mean Difference (Net)|-7.07|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Total PCS score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Total PCS score.|Null Hypothesis: The application of ATM does not affect the degree of pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||<0.001
71065445|NCT05870371|141639957|OTHER||Mean Difference (Net)|-2.02|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Rumination subscale of PCS. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Rumination subscale of PCS.|Null Hypothesis: The application of ATM does not affect the degree of pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||<0.001
71065446|NCT05870371|141639957|OTHER||Mean Difference (Net)|-1.66|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Magnification subscale of PCS. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Magnification subscale of PCS.|Null Hypothesis: The application of ATM does not affect the degree of pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||<0.001
71065447|NCT05870371|141639957|OTHER||Mean Difference (Net)|-3.39|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Helplessness subscale of PCS. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Helplessness subscale of PCS.|Null Hypothesis: The application of ATM does not affect the degree of pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||<0.001
71065448|NCT05870371|141639957|OTHER||Dependence coefficient (β)|0.01|STANDARD_ERROR_OF_MEAN|0.05|=|0.871|TWO_SIDED|||||The above p-value corresponds to the Total PCS score. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Total PCS score. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ from the application of A-S in reducing pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).|The above values correspond to the comparison which is between groups at baseline.|||=0.871
71065449|NCT05870371|141639957|OTHER||Dependence coefficient (β)|-0.01|STANDARD_ERROR_OF_MEAN|0.06|=|0.887|TWO_SIDED|||||The above p-value corresponds to the Rumination subscale of PCS. The above value correspond to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Rumination subscale of PCS. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ from the application of A-S in reducing pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||=0.887
71065450|NCT05870371|141639957|OTHER||Dependence coefficient (β)|0.01|STANDARD_ERROR_OF_MEAN|0.05|=|0.879|TWO_SIDED|||||The above p-value corresponds to the Magnification subscale of PCS. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Magnification subscale of PCS. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ from the application of A-S in reducing pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||=0.879
71065451|NCT05870371|141639957|OTHER||Dependence coefficient (β)|0.0|STANDARD_ERROR_OF_MEAN|0.05|=|0.961|TWO_SIDED|||||The above p-value corresponds to the Helplessness subscale of PCS. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Helplessness subscale of PCS. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ from the application of A-S in reducing pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||=0.961
71065452|NCT05870371|141639958|OTHER||Mean Difference (Net)|4.99|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Physical Component Summary/PCS subscale of SF-12. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Physical Component Summary/PCS subscale of SF-12.|Null Hypothesis: The application of ATM does not affect the quality of life as measured by the Short Form 12-item Health Survey (SF-12) in patients with chronic neck pain (secondary hypothesis).||||<0.001
71111472|NCT01402869|141729472|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||LSD post hoc test was used for multiple group comparisons. P\<.05|ANOVA|LSD post hoc test was used for multiple group comparisons.||Null hypothesis: There is no statistically significant difference in peak methemoglobin blood levels following the administration of prilocaine, lidocaine, or no local anesthetic in pre-cooperative children undergoing comprehensive dental rehabilitation under general anesthesia.||||<.001
71065453|NCT05870371|141639958|OTHER||Mean Difference (Net)|8.33|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Mental Component Summary/MCS subscale of SF-12. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Mental Component Summary/MCS subscale of SF-12.|Null Hypothesis: The application of ATM does not affect the quality of life as measured by the Short Form 12-item Health Survey (SF-12) in patients with chronic neck pain (secondary hypothesis).||||<0.001
71065454|NCT05870371|141639958|OTHER||Dependence coefficient (β)|-0.76|STANDARD_ERROR_OF_MEAN|1.32|=|0.564|TWO_SIDED|||||The above p-value corresponds to the Physical Component Summary/PCS of SF-12. The above p-value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Physical Component Summary/PCS subscale of SF-12. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of quality of life measured by the Short Form 12-item Health Survey (SF-12) in patients with chronic pain in the cervical spine from the application of A-S (secondary hypothesis).||||=0.564
71065455|NCT05870371|141639958|OTHER||Dependence coefficient (β)|-3.05|STANDARD_ERROR_OF_MEAN|1.34|=|0.023|TWO_SIDED|||||The above p-value corresponds to Mental Component Summary/MCS of SF-12. The above p-value corresponds to the comparison which is between groups at baseline.The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Mental Component Summary/MCS of SF-12. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of quality of life measured by the Short Form 12-item Health Survey (SF-12) in patients with chronic pain in the cervical spine from the application of A-S (secondary hypothesis).||||=0.023
71065456|NCT05870371|141639959|OTHER||||||=|0.014||||||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||=0.014
71065457|NCT05870371|141639959|OTHER||Median Difference (Net)|1.0|||||TWO_SIDED|||||||||||||
71065458|NCT05870371|141639959|OTHER||Median Difference (Net)|2.0|||||TWO_SIDED|||||||||||||
71065459|NCT01780038|141639968|OTHER||||||||||||||||||Frequencies and percentages were used to determine this secondary outcome.|||
71065460|NCT01085630|141639971|SUPERIORITY|||||||0.2423|||||||Fisher Exact|||||||0.2423
71065461|NCT01237041|141639973|SUPERIORITY|Univariate ANOVA||||||0.016||||||A priori threshold p\<0.05|ANOVA|Comparison of 3 dose-finding groups. Post-hoc comparisons between groups also done.||ANOVA to compare AUC of GH among groups||||.016
71065462|NCT01237041|141639974|SUPERIORITY|ANOVA of the 3 dose-finding groups. Data transformed using log(10) for analysis||||||0.043||||||A priori threshold for significance p\<0.05|ANOVA|||Analysis of FFA Area Under Curve in dose-finding studies. Data were log-transformed before analysis.||||.043
71065463|NCT01237041|141639975|SUPERIORITY|||||||0.543|||||||ANOVA|||ANOVA, 3 dose-finding groups||||0.543
71065464|NCT01237041|141639976|SUPERIORITY|||||||0.113|||||||ANOVA|||ANOVA, 2 groups, essentially an unpaired t-test.||||.113
71065465|NCT00651261|141639986|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78||||0.009|TWO_SIDED|95.0|0.63|0.96|||1-sided stratified log-rank|||||0.96|0.63|0.009
71065466|NCT00651261|141639987|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78||||0.0024|TWO_SIDED|95.0|0.66|0.93|||1-sided stratified log rank|||||0.93|0.66|0.0024
71065467|NCT00651261|141639989|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|||||||Fisher Exact|||||||0.15
71065468|NCT00651261|141639990|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0049|||||||1-sided stratified log rank|||||||0.0049
71065469|NCT01134107|141639992|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.36|||||TWO_SIDED|95.0|0.06|0.66|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline HbA1c|This was the primary gated analysis.||0.66|0.06|
71065470|NCT01134107|141639993|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.18|||||TWO_SIDED|95.0|-0.1|0.47|||||Least Squares Mean Difference = Insulin Lispro 6 Day (Day 1-6) minus Insulin Aspart 6 Day (Day 1-6); adjusted for Treatment + Sequence + Period + Baseline HbA1c|||0.47|-0.10|
71065471|NCT01134107|141639993|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.42|||||TWO_SIDED|95.0|0.25|0.58|||||Least Squares Mean Difference = Insulin Lispro 6 Day (Day 6) minus Insulin Lispro 6 Day (Day 2); adjusted for DayGroup + Period + Baseline HbA1c|||0.58|0.25|
71065472|NCT01134107|141639994|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.38|||||TWO_SIDED|95.0|-0.13|0.88|||||Daily Total Insulin: Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose|||0.88|-0.13|
71065473|NCT01134107|141639994|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.02|||||TWO_SIDED|95.0|-0.26|0.31|||||Daily Basal Insulin: Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose|||0.31|-0.26|
71111473|NCT01402869|141729472|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||<.001
70938204|NCT00689351|141376471|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.88|||||TWO_SIDED|95.0|0.73|1.07|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 9V: Ratio of geometric means (13vPnC, 7vPnC)||1.07|0.73|
71065474|NCT01134107|141639994|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.23|||||TWO_SIDED|95.0|-0.15|0.6|||||Daily Bolus Insulin: Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose|||0.60|-0.15|
71065475|NCT01134107|141639995|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.16|||||TWO_SIDED|95.0|0.08|0.24|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Period + Sequence + Baseline HbA1c|||0.24|0.08|
71065476|NCT01134107|141639996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.39|1.63|||||Odds Ratio of HbA1c ≤6.5% for Insulin Lispro 6 Day versus Insulin Aspart 6 Day.|||1.63|0.39|
71065477|NCT01134107|141639996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36|||||TWO_SIDED|95.0|0.2|0.63|||||Odds Ratio of HbA1c \<7% for Insulin Lispro 6 Day versus Insulin Aspart 6 Day.|||0.63|0.20|
71065478|NCT01134107|141639997|SUPERIORITY_OR_OTHER|||||||0.595||95.0||||P-value for Total Insulin Dose computed using Crossover model: Variable = Treatment + Sequence + Period + Baseline Insulin Total Dose.|Crossover Model|||||||0.595
71065479|NCT01134107|141639997|SUPERIORITY_OR_OTHER|||||||0.506||95.0||||P-value for Basal Insulin Dose computed using Crossover model: Variable = Treatment + Sequence + Period + Baseline Insulin Basal Dose.|Crossover Model|||||||0.506
71111474|NCT01402869|141729472|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||P\<.05|least significant difference post hoc|||LSD post hoc pairwise comparison||||<.001
71065480|NCT01134107|141639997|SUPERIORITY_OR_OTHER|||||||0.79||95.0||||P-value for Bolus Insulin Dose computed using Crossover model: Variable = Treatment + Sequence + Period + Baseline Insulin Bolus Dose.|Crossover Model|||||||0.790
71065481|NCT01134107|141639999|SUPERIORITY_OR_OTHER|||||||0.059||95.0|||||negative binomial test|P-value computed using a negative binomial test including factors for treatment, period and sequence.||||||0.059
71065482|NCT01134107|141640000|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for overall pump complications associated with a premature reservoir change computed using Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used.|Gart's Test|||||||1.00
71065483|NCT01134107|141640000|SUPERIORITY_OR_OTHER|||||||0.472||95.0||||P-value for overall pump complications associated with a premature infusion set change computed using Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used.|Gart's Test|||||||0.472
71065484|NCT01134107|141640001|SUPERIORITY_OR_OTHER|||||||0.383||95.0||||P-value for Premature Reservoir Change computed using negative binomial test including factors for treatment, period and sequence.|negative binomial test|||||||0.383
71065485|NCT01134107|141640001|SUPERIORITY_OR_OTHER|||||||0.499||95.0||||P-value for Premature Infusion Set Change computed using negative binomial test including factors for treatment, period and sequence.|negative binomial test|||||||0.499
71065486|NCT01134107|141640002|SUPERIORITY_OR_OTHER|||||||1||95.0||||The p-value is for the Documented Hypoglycemic Episodes category treatment arm comparison. The p-value for the All Reported Hypoglycemic Episodes category could not be generated using Gart's Test.|Gart's Test|Participants represented in both treatment groups, and with non-missing incidence value in each treatment period, were used for p-value calculation.||||||1.00
71065487|NCT01134107|141640003|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Negative Binomial Test|P-value computed using a negative binomial test including factors for treatment, period and sequence.||||||<0.001
71065488|NCT01134107|141640004|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Crossover Model|P-value computed using crossover model. Response = treatment + sequence + period + baseline body weight||||||<0.001
71065489|NCT01134107|141640005|SUPERIORITY_OR_OTHER|||||||0.147||95.0||||P-value for the Systolic Blood Pressure (SBP) computed using crossover model. Response = treatment + sequence + period + baseline systolic blood pressure.|Crossover Model|||||||0.147
71065490|NCT01134107|141640005|SUPERIORITY_OR_OTHER|||||||0.894||95.0||||P-value for Diastolic Blood Pressure (DBP) computed using crossover model. Response = treatment + sequence + period + baseline diastolic blood pressure.|Crossover Model|||||||0.894
71065491|NCT00687271|141640006|OTHER||Difference in Percentage Change|-10.0|||||TWO_SIDED|95.0|-14.6|-5.5|||Longitudinal Data Analysis (LDA) model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-5.5|-14.6|
71065492|NCT00687271|141640006|OTHER||Difference in Percentage Change|-17.9|||||TWO_SIDED|95.0|-23.4|-12.5|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-12.5|-23.4|
71065493|NCT00687271|141640009|OTHER||Difference in Percentage Change|-8.6|||||TWO_SIDED|95.0|-12.7|-4.4|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-4.4|-12.7|
71065494|NCT00687271|141640009|OTHER||Diffence in Percentage Change|-13.9|||||TWO_SIDED|95.0|-18.9|-8.9|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-8.9|-18.9|
71065495|NCT00687271|141640010|OTHER||Difference in Percentage Change|-7.7|||||TWO_SIDED|95.0|-11.5|-3.9|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-3.9|-11.5|
71111475|NCT01402869|141729472|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||=|0.89||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||=.89
71111476|NCT01402869|141729473|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001|||||||ANOVA|LSD post hoc test was used for multiple group comparisons.||Null hypothesis: There is no statistically significant difference in the time frame to peak methemoglobin levels following the administration of prilocaine, lidocaine, or no local anesthetic in pre-cooperative children undergoing comprehensive dental rehabilitation under general anesthesia.||||<.001
71111477|NCT01402869|141729473|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||=|0.43||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||=.43
70938205|NCT00689351|141376471|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.91|||||TWO_SIDED|95.0|0.7|1.19|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 14: Ratio of geometric means (13vPnC, 7vPnC)||1.19|0.70|
70938206|NCT00689351|141376471|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.97|||||TWO_SIDED|95.0|0.79|1.18|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 18C: Ratio of geometric means (13vPnC, 7vPnC)||1.18|0.79|
70938207|NCT00689351|141376471|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.92|||||TWO_SIDED|95.0|0.71|1.19|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 19F: Ratio of geometric means (13vPnC, 7vPnC)||1.19|0.71|
70938208|NCT00689351|141376471|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.04|||||TWO_SIDED|95.0|0.8|1.36|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 23F: Ratio of geometric means (13vPnC, 7vPnC)||1.36|0.80|
71065496|NCT00687271|141640010|OTHER||Difference in Percentage Change|-12.2|||||TWO_SIDED|95.0|-16.8|-7.6|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-7.6|-16.8|
71065497|NCT00687271|141640011|OTHER||Difference in Percentage Change|-7.4|||||TWO_SIDED|95.0|-10.8|-4.1|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-4.1|-10.8|
71065498|NCT00687271|141640011|OTHER||Difference in Percentage Change|-11.0|||||TWO_SIDED|95.0|-15.1|-7.0|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-7.0|-15.1|
71065499|NCT00687271|141640012|OTHER||Dfferecne in Percentage Change|-2.4|||||TWO_SIDED|95.0|-6.6|1.8|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||1.8|-6.6|
71065500|NCT00687271|141640012|OTHER||Difference in Percentage Change|-0.7|||||TWO_SIDED|95.0|-5.8|4.4|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||4.4|-5.8|
71065501|NCT00687271|141640013|OTHER||Difference in Percentage Change|-1.0|||||TWO_SIDED|95.0|-7.7|5.9|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||5.9|-7.7|
71065502|NCT00687271|141640013|OTHER||Difference in Percentage Change|5.5|||||TWO_SIDED|95.0|-4.6|16.9|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||16.9|-4.6|
71065503|NCT02314260|141640018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.917|STANDARD_ERROR_OF_MEAN|0.0318||0|TWO_SIDED|95.0|0.854|0.979||Under the nonparametric assumption. P-value \<0.05, means statistical significance|t-test, 2 sided||The positive actual state is failed induction and performing Caesarean Section, So as the numbers approaches 1, induction fails. the Y-axis of the curve is sensitivity and the x- axis is (1-Specificity).|Null hypothesis: true area = 0.5 The positive actual state is failed induction, the true positive rate (Sensitivity) is plotted in function of the false positive rate (100-Specificity)||0.979|0.854|0.000
71065504|NCT02314260|141640019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.806|STANDARD_ERROR_OF_MEAN|0.0578||0|TWO_SIDED|95.0|0.693|0.919||Under the nonparametric assumption P value \<0.05 is statistically significant|t-test, 2 sided||The positive actual state is failed induction and performing Caesarean Section, So as the numbers approaches 1, induction fails. the Y-axis of the curve is sensitivity and the x- axis is (1-specificity).|Null hypothesis: true area = 0.5 The positive actual state is failed induction, the true positive rate (Sensitivity) is plotted in function of the false positive rate (100-Specificity)||0.919|0.693|0.000
71065505|NCT02314260|141640020|SUPERIORITY_OR_OTHER||Slope|4.5|STANDARD_ERROR_OF_MEAN|0.0318||0|TWO_SIDED|95.0|0.0|10.0||P\<0.05 is significant|t-test, 2 sided||at a cutoff value of 4.5, the sensitivity for failure to labour induction is 0.83 (83%), with a specificity of 0.87(87%).|The smallest cutoff value is the minimum observed test value minus 1, and the largest cutoff value is the maximum observed test value plus 1. All the other cutoff values are the averages of two consecutive ordered observed test values.||10|0.00|0.000
71065506|NCT02314260|141640021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5|STANDARD_ERROR_OF_MEAN|0.0578||0|TWO_SIDED|95.0|0.0|10.0||P\<0.05 is significant|t-test, 2 sided||at a cutoff value of 5.5, the sensitivity for failure to labour induction is 0.83 (83%), with a specificity of 0.73 (73%).|The smallest cutoff value is the minimum observed test value minus 1, and the largest cutoff value is the maximum observed test value plus 1. All the other cutoff values are the averages of two consecutive ordered observed test values.||10|0.00|0.000
71065507|NCT02362672|141640023|SUPERIORITY||Mean Difference (Net)|-0.55||||0.0019|TWO_SIDED||||||z-test|||NKTR-181 (Double-blind Treatment Phase), Placebo (Double-blind Treatment Phase)||||0.0019
71065508|NCT02801617|141640035|NON_INFERIORITY|it will be considered not inferior if they keep the IOP goal with differences of no more than 2 mmHg analysis by protocol||||||0.861|||||||t-test, 2 sided|||||||0.861
71065509|NCT02801617|141640035|NON_INFERIORITY|it will be considered not inferior if they keep the TIOP with differences of no more than 2 mmHg||||||0.89|||||||t-test, 2 sided|||||||0.890
71065510|NCT02801617|141640036|NON_INFERIORITY|intention-to-treat analysis (ITT)||||||0.329|||||||Chi-squared|||||||0.329
71065511|NCT02801617|141640037|NON_INFERIORITY|it will be considered not inferior if they keep the percentage of ocular burning with differences of no more than 20%||||||0.388|||||||Chi-squared, Corrected|||||||0.388
70938209|NCT00689351|141376471|SUPERIORITY_OR_OTHER||Ratio of geometric means|329.44|||||TWO_SIDED|95.0|242.98|446.67|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 1: Ratio of geometric means (13vPnC, 7vPnC)||446.67|242.98|
70938210|NCT00689351|141376471|SUPERIORITY_OR_OTHER||Ratio of geometric means|40.79|||||TWO_SIDED|95.0|30.27|54.97|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 3: Ratio of geometric means (13vPnC, 7vPnC)||54.97|30.27|
70938211|NCT00689351|141376471|SUPERIORITY_OR_OTHER||Ratio of geometric means|13.12|||||TWO_SIDED|95.0|9.92|17.34|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 5: Ratio of geometric means (13vPnC, 7vPnC)||17.34|9.92|
71065512|NCT02801617|141640038|NON_INFERIORITY|it will be considered not inferior if they keep the percentage of ocular burning with differences of no more than 20%||||||0.125|||||||Chi-squared, Corrected|||||||0.125
71065513|NCT02801617|141640039|NON_INFERIORITY|it will be considered not inferior if they keep the percentage of ocular burning with differences of no more than 20%||||||0.434|||||||Chi-squared, Corrected|||||||0.434
71065514|NCT02801617|141640040|NON_INFERIORITY|it will be considered not inferior if they keep the percentage of ocular burning with differences of no more than 20%||||||0|||||||Chi-squared, Corrected|||||||0
71065515|NCT02801617|141640041|NON_INFERIORITY|it will be considered not inferior if they keep the percentage of ocular burning with differences of no more than 20%||||||0.039|||||||Chi-squared|||||||0.039
71111478|NCT01402869|141729473|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||<.001
71111479|NCT01402869|141729473|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||<.001
71111480|NCT01402869|141729474|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||95.0||||P\<.05|ANOVA|LSD post hoc test was used for multiple group comparisons.||Null hypothesis: There is no statistically significant difference in delta methemoglobin blood levels following the administration prilocaine, lidocaine, or no local anesthetic in pre-cooperative children undergoing comprehensive dental rehabilitation under general anesthesia.||||<.001
71111481|NCT01402869|141729474|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||<.001
70938212|NCT00689351|141376471|SUPERIORITY_OR_OTHER||Ratio of geometric means|9.01|||||TWO_SIDED|95.0|6.46|12.56|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 6A: Ratio of geometric means (13vPnC, 7vPnC)||12.56|6.46|
71065516|NCT01081769|141640064|SUPERIORITY_OR_OTHER|||||||0.0191|||||||Log Rank|||||||0.0191
71065517|NCT01081769|141640078|SUPERIORITY_OR_OTHER|||||||0.0323|||||||Fisher Exact|||||||0.0323
71065518|NCT00507455|141640079|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was less than 15 cmH2O for PdetQmax, then the treatment is non-inferior to the placebo in PdetQmax.|LS Mean Difference|-6.15|||||TWO_SIDED|95.0|-14.67|2.37|||||Least squares (LS) means were analyzed using analysis of covariance (ANCOVA) with the site and treatment group as the factors and the baseline value as the covariate.|A hierarchical step-down procedure was used to control for multiplicity. The comparison between solifenacin 6 mg + tamsulosin 0.4 mg and placebo was conducted first. If non-inferiority was demonstrated, solifenacin 9 mg + tamsulosin 0.4 mg was then compared to placebo. If the first comparison did not demonstrate non-inferiority, no further testing was performed. This procedure maintained the overall type I error of 1-sided 2.5%.||2.37|-14.67|
71065519|NCT00507455|141640079|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was less than 15 cmH2O for PdetQmax, then the treatment is non-inferior to the placebo in PdetQmax.|LS Mean Difference|-5.0|||||TWO_SIDED|95.0|-13.85|3.84|||||Least squares (LS) means were analyzed using analysis of covariance (ANCOVA) with the site and treatment group as the factors and the baseline value as the covariate.|A hierarchical step-down procedure was used to control for multiplicity. The comparison between solifenacin 6 mg + tamsulosin 0.4 mg and placebo was conducted first. If non-inferiority was demonstrated, solifenacin 9 mg + tamsulosin 0.4 mg was then compared to placebo. If the first comparison did not demonstrate non-inferiority, no further testing was performed. This procedure maintained the overall type I error of 1-sided 2.5%.||3.84|-13.85|
71065520|NCT00507455|141640081|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was greater than -3 mL/sec for Qmax, then the treatment is non-inferior to the placebo in Qmax.|LS Mean Difference|1.67|||||TWO_SIDED|95.0|0.5|2.85|||||Least squares (LS) means were analyzed using analysis of covariance (ANCOVA) with the site and treatment group as the factors and the baseline value as the covariate.|A hierarchical step-down procedure was used to control for multiplicity. The comparison between solifenacin 6 mg + tamsulosin 0.4 mg and placebo was conducted first. If non-inferiority was demonstrated, solifenacin 9 mg + tamsulosin 0.4 mg was then compared to placebo. If the first comparison did not demonstrate non-inferiority, no further testing was performed. This procedure maintained the overall type I error of 1-sided 2.5%.||2.85|0.50|
71111482|NCT01402869|141729474|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||<.001
71111483|NCT01402869|141729474|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||=|0.92||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||=.92
71111484|NCT01740687|141729475|OTHER||95% upper Bayesian credible interval|1.23|||||||||||||%|predetermined study success threshold of 2.1% at 1 year||||
71111485|NCT01740687|141729476|OTHER||95% upper Bayesian credible interval|1.33|||||||||||||%|predetermined study success threshold of 2.8% at 3 years||||
71111486|NCT01963767|141729483|SUPERIORITY_OR_OTHER|||||||0.03|||||||ANCOVA|||Ancovas were conducted with group as the between subjects factor and performance at baseline as the covariate.||||.03
71111487|NCT03941483|141729490|SUPERIORITY||Risk Ratio (RR)|1.174||||0.595|TWO_SIDED|90.0|0.715|1.927|||Chi-squared|||||1.927|0.715|0.595
71111488|NCT03941483|141729491|SUPERIORITY||Risk Ratio (RR)|1.297||||0.335|TWO_SIDED|90.0|0.831|2.026|||Chi-squared|||||2.026|0.831|0.335
71111489|NCT03941483|141729492|SUPERIORITY||Risk Ratio (RR)|1.025||||0.773|TWO_SIDED|90.0|0.891|1.179|||Chi-squared|||||1.179|0.891|0.773
70852667|NCT01578850|141194329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||<|0.001|TWO_SIDED|95.0|-0.73|-0.2|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 28||-0.20|-0.73|<0.001
71065521|NCT00507455|141640081|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was greater than -3 mL/sec for Qmax, then the treatment is non-inferior to the placebo in Qmax.|LS Mean Difference|2.18|||||TWO_SIDED|95.0|0.98|3.37|||||Least squares (LS) means were analyzed using analysis of covariance (ANCOVA) with the site and treatment group as the factors and the baseline value as the covariate.|A hierarchical step-down procedure was used to control for multiplicity. The comparison between solifenacin 6 mg + tamsulosin 0.4 mg and placebo was conducted first. If non-inferiority was demonstrated, solifenacin 9 mg + tamsulosin 0.4 mg was then compared to placebo. If the first comparison did not demonstrate non-inferiority, no further testing was performed. This procedure maintained the overall type I error of 1-sided 2.5%.||3.37|0.98|
71065522|NCT04994691|141640099|SUPERIORITY||Risk Ratio (RR)|1.92||||0|TWO_SIDED|95.0|1.38|2.6|||Regression, Logistic||Standard Message vs. No Message|||2.60|1.38|0.000
71065523|NCT04994691|141640099|SUPERIORITY||Risk Ratio (RR)|1.52||||0.023|TWO_SIDED|95.0|1.06|2.13|||Regression, Logistic||Tailored Message vs. No Message|||2.13|1.06|0.023
71065524|NCT04994691|141640099|SUPERIORITY||Risk Ratio (RR)|1.26||||0.124|TWO_SIDED|95.0|0.94|1.66|||Regression, Logistic||Standard Message vs. Tailored Message|||1.66|0.94|0.124
71065525|NCT04994691|141640100|SUPERIORITY||Risk Ratio (RR)|1.97||||0.001|TWO_SIDED|95.0|1.32|2.84|||Regression, Logistic||Standard Message vs. No Message|||2.84|1.32|0.001
71065526|NCT04994691|141640100|SUPERIORITY||Risk Ratio (RR)|1.57||||0.04|TWO_SIDED|95.0|1.02|2.34|||Regression, Logistic||Tailored Message vs. No Message|||2.34|1.02|0.040
71065527|NCT04994691|141640100|SUPERIORITY||Risk Ratio (RR)|1.26||||0.202|TWO_SIDED|95.0|0.88|1.74|||Regression, Logistic||Standard Message vs. Tailored Message|||1.74|0.88|0.202
71065528|NCT01814696|141640146|SUPERIORITY_OR_OTHER_LEGACY|||||||0.605||||||a prior threshold p\<0.05|Fisher Exact|||||||0.605
71065529|NCT01814696|141640147|SUPERIORITY_OR_OTHER_LEGACY|||||||0.604|TWO_SIDED||||||Fisher Exact|||Heart failure related ED visits||||0.604
70852668|NCT01578850|141194329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.006|TWO_SIDED|95.0|-0.61|-0.11|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 28||-0.11|-0.61|0.006
71065530|NCT01814696|141640147|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Fisher Exact|||Non-heart failure related ED visits||||1.000
71065531|NCT01814696|141640147|SUPERIORITY_OR_OTHER_LEGACY|||||||0.677|TWO_SIDED||||||Fisher Exact|||All cause ED visits||||0.677
71065532|NCT01814696|141640148|SUPERIORITY_OR_OTHER_LEGACY|||||||0.341|TWO_SIDED||||||Fisher Exact|||||||0.341
71065533|NCT01814696|141640148|SUPERIORITY_OR_OTHER_LEGACY|||||||0.042|TWO_SIDED||||||Fisher Exact|||||||0.042
71065534|NCT01814696|141640149|SUPERIORITY_OR_OTHER_LEGACY|||||||0.497|TWO_SIDED||||||Wilcoxon rank-sum test|||All cause||||0.497
71065535|NCT01814696|141640149|SUPERIORITY_OR_OTHER_LEGACY|||||||0.413|TWO_SIDED||||||Wilcoxon rank-sum test|||Heart failure related||||0.413
71065536|NCT01814696|141640149|SUPERIORITY_OR_OTHER_LEGACY|||||||0.944|TWO_SIDED||||||Wilcoxon rank-sum test|||Non-heart failure ED visits||||0.944
71065537|NCT01814696|141640150|SUPERIORITY_OR_OTHER_LEGACY|||||||0.057|TWO_SIDED||||||Wilcoxon rank-sum test|||All cause||||0.057
70852669|NCT01578850|141194329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|||<|0.001|TWO_SIDED|95.0|-0.96|-0.39|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 36||-0.39|-0.96|<0.001
71065538|NCT01814696|141640150|SUPERIORITY_OR_OTHER_LEGACY|||||||0.236|TWO_SIDED||||||Wilcoxon rank-sum test|||Heart failure related||||0.236
71065539|NCT01814696|141640150|SUPERIORITY_OR_OTHER_LEGACY|||||||0.236|TWO_SIDED||||||Wilcoxon rank-sum test|||Non heart failure related||||0.236
71065540|NCT01814696|141640151|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034|||||||Wilcoxon rank-sum test|||All cause||||0.034
70852670|NCT01578850|141194329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|||<|0.001|TWO_SIDED|95.0|-0.82|-0.28|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 36||-0.28|-0.82|<0.001
71065541|NCT01814696|141640151|SUPERIORITY_OR_OTHER_LEGACY|||||||0.196|||||||Wilcoxon rank-sum test|||Heart failure related||||0.196
71065542|NCT01814696|141640151|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21|TWO_SIDED||||||Wilcoxon rank-sum test|||Non heart failure related||||0.210
71065543|NCT01814696|141640152|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||||||0.002
71065544|NCT00812981|141640177|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was defined as the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio of HI antibodies against the A/Indonesia/05/2005 strain between the two groups (1562902A CP Group over 1562902A NP Group), being below (\<) 2.0.|Adjusted GMT ratio|0.84|||||TWO_SIDED|95.0|0.71|0.99|||ANCOVA|||Difference in adjusted GMT ratio for HI antibodies: To demonstrate that the NP 1562902A vaccine was non-inferior to the CP 1562902A vaccine, with respect to HI antibody GMT against the A/Indonesia/05/2005 strain, 42 days following vaccination.||0.99|0.71|
71065545|NCT04205643|141640216|SUPERIORITY||Difference estimated using CMH weights|21.1|||<|0.0001|TWO_SIDED|95.0|11.8|29.3||If the primary endpoint is significant, a fixed sequence procedure was employed to control the overall type I error rate of the key secondary endpoints.|Cochran-Mantel-Haenszel|Stratified by Previous biologic agent and/or JAK inhibitors exposure, Use of oral corticosteroids treatment at Week 0, Clinical remission at Week 10.|The 95% stratified Newcombe CI with CMH weights|||29.3|11.8|<0.0001
71065546|NCT01757184|141640237|SUPERIORITY|||||||0.0271|||||||Fisher Exact|Fisher's exact test at α=0.05.||A sample size of 50 randomized participants (approximately 25 participants per treatment group) provided 97% power to detect a statistically significant difference between sebelipase alfa and placebo, using Fisher's exact test at α=0.05.||||0.0271
71065547|NCT01757184|141640238|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71065548|NCT01757184|141640239|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71065549|NCT01757184|141640240|SUPERIORITY|||||||0.0003|||||||Fisher Exact|||||||0.0003
71065550|NCT01757184|141640241|SUPERIORITY|||||||0.0375|||||||Wilcoxon (Mann-Whitney)|||||||0.0375
71065551|NCT01757184|141640242|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71065552|NCT01757184|141640243|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71065553|NCT01757184|141640244|SUPERIORITY|||||||0.4216|||||||Fisher Exact|||||||0.4216
71065554|NCT01757184|141640245|SUPERIORITY|||||||0.0068|||||||Wilcoxon (Mann-Whitney)|||||||0.0068
71065555|NCT01014169|141640256|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.13|||||TWO_SIDED|95.0|0.95|1.34||||||||1.34|0.95|
71065556|NCT01014169|141640257|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.99|1.25||||||||1.25|0.99|
71065557|NCT01014169|141640258|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.12||||||95.0|1.0|1.25||||||||1.25|1.00|
71065558|NCT02589639|141640264|SUPERIORITY|The superiority of empagliflozin 10 mg against placebo was tested for change from baseline in HbA1c after 16 weeks of treatment at the level of α=0.05 (2-sided)|Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.11|-0.73|||ANCOVA|Analysis of Covariance (ANCOVA) comparing the change from baseline in HbA1c after 16 weeks of treatment||"The statistical model was:~Change from baseline in HbA1c after 16 weeks = overall mean + baseline HbA1c + treatment + baseline renal function + type of insulin therapies + random error"|Adjusted Mean Difference calculated as (Empagliflozin 10 mg - Placebo)|-0.73|-1.11|<0.0001
71065559|NCT02589639|141640264|SUPERIORITY|The superiority of empagliflozin 25 mg against placebo was tested for change from baseline in HbA1c after 16 weeks of treatment at the level of α=0.05 (2-sided)|Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.18|-0.82|||ANCOVA|Analysis of Covariance (ANCOVA) comparing the change from baseline in HbA1c after 16 weeks of treatment|Adjusted Mean Difference calculated as (Empagliflozin 10 mg - Placebo)|The statistical model was: Change from baseline in HbA1c after 16 weeks = overall mean + baseline HbA1c + treatment + baseline renal function + type of insulin therapies + random error||-0.82|-1.18|<0.0001
71065560|NCT02593097|141640276|SUPERIORITY|||||||0.83|||||||Hills-Armitage|||||||0.83
71065561|NCT02593097|141640277|SUPERIORITY|||||||0.16|||||||McNemar|||||||0.16
71065562|NCT01554527|141640303|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||Intent to treat for controls vs. treatment (adherent/non-adherent)||||0.07
71065563|NCT01554527|141640304|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|||Intent to treat for controls vs. treatment (adherent/non-adherent)||||0.34
71065564|NCT01554527|141640305|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||Intent to treat for controls vs. treatment (adherent/non-adherent)||||0.93
71065565|NCT01554527|141640306|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||Intent to treat for controls vs. treatment (adherent/non-adherent)||||0.5
71065566|NCT01554527|141640307|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||Intent to treat for controls vs. treatment (adherent/non-adherent)||||0.25
71065567|NCT01052480|141640311|SUPERIORITY_OR_OTHER|||||||0.069|||||||Log Rank|||||||0.069
71065568|NCT00529373|141640333|OTHER||Hazard Ratio (HR)|0.46|||<|0.001|TWO_SIDED|95.0|0.4|0.53|||Generalized linear model|||Odanacatib 50 mg OW vs Placebo. Generalized linear model for binary data with cloglog link and terms for time interval, treatment, stratum, and geographic region. cloglog link = complementary log log transformation of probability of an event up to the time-point.||0.53|0.40|<0.001
71065569|NCT00529373|141640334|OTHER||Hazard Ratio (HR)|0.53|||<|0.001|TWO_SIDED|95.0|0.39|0.71|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.71|0.39|<0.001
71065570|NCT00529373|141640335|OTHER||Hazard Ratio (HR)|0.77|||<|0.001|TWO_SIDED|95.0|0.68|0.87|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.87|0.68|<0.001
71065571|NCT00529373|141640336|OTHER||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|95.0|0.42|0.55|||Generalized linear model|||Odanacatib 50 mg OW vs Placebo. Generalized linear model for binary data with cloglog link and terms for time interval, treatment, stratum, and geographic region. cloglog link = complementary log log transformation of probability of an event up to the time-point.||0.55|0.42|<0.001
71065572|NCT00529373|141640337|OTHER||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.4|0.67|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.67|0.40|<0.001
71065573|NCT00529373|141640338|OTHER||Hazard Ratio (HR)|0.74|||<|0.001|TWO_SIDED|95.0|0.66|0.83|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.83|0.66|<0.001
71065574|NCT00529373|141640339|OTHER|Miettinen \& Nurminen|Difference in rates|0.88|||||TWO_SIDED|95.0|-2.3|4.07||||||||4.07|-2.3|
71065575|NCT00529373|141640340|OTHER|Miettinen \& Nurminen|Difference in rates|0.11|||||TWO_SIDED|95.0|-0.16|0.37||||||||0.37|-0.16|
71065576|NCT00529373|141640344|OTHER||Difference in Least Squares Means|8.92|||<|0.001|TWO_SIDED|95.0|3.9|13.93|||Longitudinal model|||Odanacatib 50 mg vs Placebo||13.93|3.9|<0.001
71065577|NCT00529373|141640345|OTHER||Difference in Least Squares Means|26.45|||<|0.001|TWO_SIDED|95.0|16.49|36.4|||Longitudinal model|||Odanacatib 50 mg vs Placebo||36.40|16.49|<0.001
71065578|NCT00529373|141640346|OTHER||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.14|0.09||||||Odanacatib 50 mg OW - Placebo at Month 12. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.09|-0.14|
71065579|NCT00529373|141640346|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.12|0.12||||||Odanacatib 50 mg OW - Placebo at Month 24. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.12|-0.12|
71065580|NCT00529373|141640346|OTHER||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.17|0.09||||||Odanacatib 50 mg OW - Placebo at Month 36. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.09|-0.17|
71065581|NCT00529373|141640346|OTHER||Mean Difference (Final Values)|-0.21|||||TWO_SIDED|95.0|-0.5|0.08||||||Odanacatib 50 mg OW - Placebo at Month 48. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.08|-0.50|
71065582|NCT00529373|141640347|OTHER||Difference in Least Squares Means|0.11|||||TWO_SIDED|95.0|-0.16|0.38||||||Odanacatib 50 mg OW - Placebo at Month 12. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.38|-0.16|
70852671|NCT01578850|141194329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75|||<|0.001|TWO_SIDED|95.0|-1.03|-0.46|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 44||-0.46|-1.03|<0.001
70852672|NCT01578850|141194329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|||<|0.001|TWO_SIDED|95.0|-0.92|-0.37|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 44||-0.37|-0.92|<0.001
70938213|NCT00689351|141376471|SUPERIORITY_OR_OTHER||Ratio of geometric means|165.9|||||TWO_SIDED|95.0|122.95|223.85|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 7F: Ratio of geometric means (13vPnC, 7vPnC)||223.85|122.95|
70938214|NCT00689351|141376471|SUPERIORITY_OR_OTHER||Ratio of geometric means|2.24|||||TWO_SIDED|95.0|1.83|2.75|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 19A: Ratio of geometric means (13vPnC, 7vPnC)||2.75|1.83|
70938215|NCT00689351|141376472|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.78|||||TWO_SIDED|95.0|0.6|1.02|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 4: Ratio of geometric means (13vPnC, 7vPnC)||1.02|0.60|
71065583|NCT00529373|141640347|OTHER||Difference in Least Squares Means|0.14|||||TWO_SIDED|95.0|-0.15|0.44||||||Odanacatib 50 mg OW - Placebo at Month 24. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.44|-0.15|
70852673|NCT01578850|141194329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|||<|0.001|TWO_SIDED|95.0|-0.98|-0.4|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 52||-0.40|-0.98|<0.001
70852674|NCT01578850|141194329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|||<|0.001|TWO_SIDED|95.0|-0.91|-0.36|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 52||-0.36|-0.91|<0.001
70852675|NCT01578850|141194330|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||||||<0.001
70852676|NCT01578850|141194332|SUPERIORITY_OR_OTHER||Difference in proportions|1.4||||0.961|TWO_SIDED|95.0|-6.13|8.9|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-CRP Week 24||8.90|-6.13|0.961
70852677|NCT01578850|141194332|SUPERIORITY_OR_OTHER||Difference in proportions|21.5||||0.001|TWO_SIDED|95.0|10.99|32.02|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-ESR Week 28||32.02|10.99|0.001
70852678|NCT01578850|141194332|SUPERIORITY_OR_OTHER||Difference in proportions|18.3||||0.007|TWO_SIDED|95.0|8.08|28.53|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-CRP Week 28||28.53|8.08|0.007
71065584|NCT00529373|141640347|OTHER||Difference in Least Squares Means|0.19|||||TWO_SIDED|95.0|-0.15|0.54||||||Odanacatib 50 mg OW - Placebo at Month 36. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.54|-0.15|
71065585|NCT00529373|141640347|OTHER||Difference in Least Squares Means|0.19|||||TWO_SIDED|95.0|-0.24|0.62||||||Odanacatib 50 mg OW - Placebo at Month 48. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.62|-0.24|
71065586|NCT00529373|141640348|OTHER||Difference in Least Squares Means|0.04|||||TWO_SIDED|95.0|-0.08|0.15||||||Odanacatib 50 mg OW - Placebo at Month 12. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.15|-0.08|
70852679|NCT01578850|141194332|SUPERIORITY_OR_OTHER||Difference in proportions|31.4|||<|0.001|TWO_SIDED|95.0|21.42|41.39|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-ESR Week 36||41.39|21.42|<0.001
70852680|NCT01578850|141194332|SUPERIORITY_OR_OTHER||Difference in proportions|27.2|||<|0.001|TWO_SIDED|95.0|16.83|37.54|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-CRP Week 36||37.54|16.83|<0.001
70852681|NCT01578850|141194332|SUPERIORITY_OR_OTHER||Difference in proportions|31.3|||<|0.001|TWO_SIDED|95.0|21.53|41.02|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-ESR Week 44||41.02|21.53|<0.001
70852682|NCT01578850|141194332|SUPERIORITY_OR_OTHER||Difference in proportions|30.8|||<|0.001|TWO_SIDED|95.0|20.54|41.05|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-CRP Week 44||41.05|20.54|<0.001
70852683|NCT01578850|141194332|SUPERIORITY_OR_OTHER||Difference in proportions|26.3|||<|0.001|TWO_SIDED|95.0|16.82|35.74|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-ESR Week 52||35.74|16.82|<0.001
70852684|NCT01578850|141194332|SUPERIORITY_OR_OTHER||Difference in proportions|27.0|||<|0.001|TWO_SIDED|95.0|16.63|37.44|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-CRP Week 52||37.44|16.63|<0.001
71065587|NCT00529373|141640348|OTHER||Difference in Least Squares Means|0.08|||||TWO_SIDED|95.0|-0.06|0.21||||||Odanacatib 50 mg OW - Placebo at Month 24. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.21|-0.06|
71065588|NCT00529373|141640348|OTHER||Difference in Least Squares Means|0.03|||||TWO_SIDED|95.0|-0.12|0.17||||||Odanacatib 50 mg OW - Placebo at Month 36. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.17|-0.12|
71065589|NCT00529373|141640348|OTHER||Difference in Least Squares Means|0.09|||||TWO_SIDED|95.0|-0.09|0.28||||||Odanacatib 50 mg OW - Placebo at Month 48. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.28|-0.09|
71065590|NCT00529373|141640349|OTHER|Miettinen \& Nurminen|Difference in rates|1.52|||||TWO_SIDED|95.0|-1.8|4.84||||||||4.84|-1.8|
71065591|NCT00529373|141640350|OTHER|Miettinen \& Nurminen|Difference in rates|0.27|||||TWO_SIDED|95.0|-0.04|0.58||||||||0.58|-0.04|
71065592|NCT00529373|141640351|OTHER||Hazard Ratio (HR)|0.28|||<|0.001|TWO_SIDED|95.0|0.19|0.4|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.40|0.19|<0.001
71065593|NCT00529373|141640352|OTHER||Difference in Least Squares Means|0.01||||0.041|TWO_SIDED|95.0|0.0|0.03|||Mixed Models Analysis|||Odanacatib 50 mg OW versus Placebo. The mixed model contained fixed effects for treatment, region, stratum, treatment-year interaction and random effect intercept and slope (year) and unstructured covariance matrix.||0.03|0.00|0.041
71065594|NCT00529373|141640353|OTHER||Odds Ratio (OR)|0.89||||0.014|TWO_SIDED|95.0|0.81|0.98|||Logistic model|||Odanacatib 50 mg OW versus Placebo. Treatment comparison for height loss at any time during the treatment period. The logistic model contained terms for treatment, geographic region and stratum.||0.98|0.81|0.014
71065595|NCT00529373|141640354|OTHER||Difference in Least Squares Means|1.32|||<|0.001|TWO_SIDED|95.0|0.9|1.75|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||1.75|0.90|<0.001
71065596|NCT00529373|141640354|OTHER||Difference in Least Squares Means|2.49|||<|0.001|TWO_SIDED|95.0|2.37|2.61|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.61|2.37|<0.001
71065597|NCT00529373|141640354|OTHER||Difference in Least Squares Means|4.47|||<|0.001|TWO_SIDED|95.0|4.31|4.62|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.62|4.31|<0.001
71065598|NCT00529373|141640354|OTHER||Difference in Least Squares Means|6.44|||<|0.001|TWO_SIDED|95.0|6.25|6.64|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.64|6.25|<0.001
71065599|NCT00529373|141640354|OTHER||Difference in Least Squares Means|8.62|||<|0.001|TWO_SIDED|95.0|8.11|9.12|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||9.12|8.11|<0.001
71065600|NCT00529373|141640354|OTHER||Difference in Least Squares Means|9.49|||<|0.001|TWO_SIDED|95.0|8.7|10.29|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||10.29|8.70|<0.001
71065601|NCT00529373|141640355|OTHER||Difference in Least Squares Means|2.96|||<|0.001|TWO_SIDED|95.0|2.47|3.46|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||3.46|2.47|<0.001
71065602|NCT00529373|141640355|OTHER||Difference in Least Squares Means|4.07|||<|0.001|TWO_SIDED|95.0|3.93|4.22|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.22|3.93|<0.001
71065603|NCT00529373|141640355|OTHER||Difference in Least Squares Means|6.05|||<|0.001|TWO_SIDED|95.0|5.87|6.23|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.23|5.87|<0.001
71065604|NCT00529373|141640355|OTHER||Difference in Least Squares Means|7.84|||<|0.001|TWO_SIDED|95.0|7.62|8.06|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||8.06|7.62|<0.001
70938216|NCT00689351|141376472|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.11|||||TWO_SIDED|95.0|0.83|1.48|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 6B: Ratio of geometric means (13vPnC, 7vPnC)||1.48|0.83|
70938217|NCT00689351|141376472|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.95|||||TWO_SIDED|95.0|0.76|1.19|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 9V: Ratio of geometric means (13vPnC, 7vPnC)||1.19|0.76|
70938218|NCT00689351|141376472|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.74|||||TWO_SIDED|95.0|0.57|0.95|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 14: Ratio of geometric means (13vPnC, 7vPnC)||0.95|0.57|
71065605|NCT00529373|141640355|OTHER||Difference in Least Squares Means|9.72|||<|0.001|TWO_SIDED|95.0|9.16|10.27|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||10.27|9.16|<0.001
71065606|NCT00529373|141640355|OTHER||Difference in Least Squares Means|11.23|||<|0.001|TWO_SIDED|95.0|10.23|12.23|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||12.23|10.23|<0.001
71065607|NCT00529373|141640356|OTHER||Difference in Least Squares Means|1.49|||<|0.001|TWO_SIDED|95.0|0.95|2.03|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.03|0.95|<0.001
71065608|NCT00529373|141640356|OTHER||Difference in Least Squares Means|2.21|||<|0.001|TWO_SIDED|95.0|2.05|2.37|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.37|2.05|<0.001
71065609|NCT00529373|141640356|OTHER||Difference in Least Squares Means|4.38|||<|0.001|TWO_SIDED|95.0|4.19|4.57|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.57|4.19|<0.001
71065610|NCT00529373|141640356|OTHER||Difference in Least Squares Means|6.46|||<|0.001|TWO_SIDED|95.0|6.24|6.68|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.68|6.24|<0.001
71065611|NCT00529373|141640356|OTHER||Difference in Least Squares Means|8.42|||<|0.001|TWO_SIDED|95.0|7.82|9.02|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||9.02|7.82|<0.001
71065612|NCT00529373|141640356|OTHER||Difference in Least Squares Means|8.53|||<|0.001|TWO_SIDED|95.0|7.54|9.53|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||9.53|7.54|<0.001
71065613|NCT00529373|141640357|OTHER||Difference in Least Squares Means|1.74|||<|0.001|TWO_SIDED|95.0|1.03|2.46|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.46|1.03|<0.001
71065614|NCT00529373|141640357|OTHER||Difference in Least Squares Means|3.5|||<|0.001|TWO_SIDED|95.0|3.31|3.7|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||3.70|3.31|<0.001
71065615|NCT00529373|141640357|OTHER||Difference in Least Squares Means|6.41|||<|0.001|TWO_SIDED|95.0|6.17|6.65|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 24||6.65|6.17|<0.001
71065616|NCT00529373|141640357|OTHER||Difference in Least Squares Means|9.27|||<|0.001|TWO_SIDED|95.0|8.98|9.57|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 36||9.57|8.98|<0.001
71111490|NCT03941483|141729493|SUPERIORITY||Risk Ratio (RR)|1.038||||0.563|TWO_SIDED|90.0|0.935|1.152|||Chi-squared|||||1.152|0.935|0.563
71065617|NCT00529373|141640357|OTHER||Difference in Least Squares Means|12.44|||<|0.001|TWO_SIDED|95.0|11.66|13.22|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 48||13.22|11.66|<0.001
71065618|NCT00529373|141640357|OTHER||Difference in Least Squares Means|13.81|||<|0.001|TWO_SIDED|95.0|12.58|15.04|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 60||15.04|12.58|<0.001
71065619|NCT00529373|141640358|OTHER||Difference in Least Squares Means|1.11|||<|0.001|TWO_SIDED|95.0|0.67|1.55|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||1.55|0.67|<0.001
71111491|NCT03941483|141729494|SUPERIORITY||Risk Ratio (RR)|1.174||||0.717|TWO_SIDED|90.0|0.567|2.429|||Chi-squared|||||2.429|0.567|0.717
71111492|NCT03941483|141729495|SUPERIORITY||Risk Ratio (RR)|1.614||||0.266|TWO_SIDED|90.0|0.789|3.3|||Chi-squared|||||3.300|0.789|0.266
70938219|NCT00689351|141376472|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.92|||||TWO_SIDED|95.0|0.72|1.19|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 18C: Ratio of geometric means (13vPnC, 7vPnC)||1.19|0.72|
71065620|NCT00529373|141640358|OTHER||Difference in Least Squares Means|1.35|||<|0.001|TWO_SIDED|95.0|0.85|1.84|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||1.84|0.85|<0.001
71065621|NCT00529373|141640358|OTHER||Difference in Least Squares Means|1.93|||<|0.001|TWO_SIDED|95.0|1.38|2.47|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.47|1.38|<0.001
71065622|NCT00529373|141640358|OTHER||Difference in Least Squares Means|2.2||||0.001|TWO_SIDED|95.0|0.89|3.51|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||3.51|0.89|0.001
71065623|NCT00529373|141640358|OTHER||Difference in Least Squares Means|3.5||||0.001|TWO_SIDED|95.0|1.46|5.54|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||5.54|1.46|0.001
71065624|NCT00529373|141640359|OTHER||Difference in Least Squares Means|5.79|||<|0.001|TWO_SIDED|95.0|5.37|6.2|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.2|5.37|<0.001
71065625|NCT00529373|141640359|OTHER||Difference in Least Squares Means|4.02|||<|0.001|TWO_SIDED|95.0|3.67|4.37|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.37|3.67|<0.001
70938220|NCT00689351|141376472|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.45|||||TWO_SIDED|95.0|1.11|1.88|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 19F: Ratio of geometric means (13vPnC, 7vPnC)||1.88|1.11|
71065626|NCT00529373|141640359|OTHER||Difference in Least Squares Means|7.62|||<|0.001|TWO_SIDED|95.0|7.11|8.13|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||8.13|7.11|<0.001
71065627|NCT00529373|141640359|OTHER||Difference in Least Squares Means|9.51|||<|0.001|TWO_SIDED|95.0|7.96|11.06|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||11.06|7.96|<0.001
71065628|NCT00529373|141640360|OTHER||Difference in Least Squares Means|2.4|||<|0.001|TWO_SIDED|95.0|2.11|2.68|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.68|2.11|<0.001
71065629|NCT00529373|141640360|OTHER||Difference in Least Squares Means|4.21|||<|0.001|TWO_SIDED|95.0|3.84|4.57|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.57|3.84|<0.001
71065630|NCT00529373|141640360|OTHER||Difference in Least Squares Means|5.86|||<|0.001|TWO_SIDED|95.0|5.41|6.3|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.30|5.41|<0.001
71065631|NCT00529373|141640360|OTHER||Difference in Least Squares Means|8.54|||<|0.001|TWO_SIDED|95.0|7.0|10.09|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||10.09|7.00|<0.001
71065632|NCT00529373|141640361|OTHER||Difference in Least Squares Means|2.21|||<|0.001|TWO_SIDED|95.0|1.83|2.59|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.59|1.83|<0.001
71065633|NCT00529373|141640361|OTHER||Difference in Least Squares Means|4.33|||<|0.001|TWO_SIDED|95.0|3.87|4.78|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.78|3.87|<0.001
71065634|NCT00529373|141640361|OTHER||Difference in Least Squares Means|6.09|||<|0.001|TWO_SIDED|95.0|5.56|6.62|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.62|5.56|<0.001
71065635|NCT00529373|141640361|OTHER||Difference in Least Squares Means|9.08|||<|0.001|TWO_SIDED|95.0|6.97|11.19|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||11.19|6.97|<0.001
71111493|NCT01082081|141729496|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.77||||0.0004|TWO_SIDED|95.0|2.15|7.39|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID\^6h between Paracetamol 1000 mg caplet and Paracetamol 500 mg caplet.||7.39|2.15|0.0004
70941769|NCT04748445|141383935|OTHER||Slope|2.51|STANDARD_ERROR_OF_MEAN|1.904||0.1897|TWO_SIDED|90.0|-6.446|5.665|||Mixed Models Analysis|||READ\_MFCC 1st order delta 06 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-4. For lower limit it was 10\^-5).||5.665|-6.446|0.1897
71065636|NCT00529373|141640362|OTHER||Difference in Least Squares Means|3.44|||<|0.001|TWO_SIDED|95.0|2.98|3.9|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 12||3.90|2.98|<0.001
71065637|NCT00529373|141640362|OTHER||Difference in Least Squares Means|6.03|||<|0.001|TWO_SIDED|95.0|5.47|6.59|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.59|5.47|<0.001
71065638|NCT00529373|141640362|OTHER||Difference in Least Squares Means|8.49|||<|0.001|TWO_SIDED|95.0|7.81|9.16|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||9.16|7.81|<0.001
71065639|NCT00529373|141640362|OTHER||Difference in Least Squares Means|11.76|||<|0.001|TWO_SIDED|95.0|9.15|14.36|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||14.36|9.15|<0.001
71065640|NCT00529373|141640363|OTHER||Difference in Least Squares Means|1.08||||0.083|TWO_SIDED|95.0|-0.14|2.31|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.31|-0.14|0.083
71065641|NCT00529373|141640363|OTHER||Difference in Least Squares Means|1.05||||0.129|TWO_SIDED|95.0|-0.31|2.4|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.40|-0.31|0.129
71065642|NCT00529373|141640363|OTHER||Difference in Least Squares Means|1.21||||0.104|TWO_SIDED|95.0|-0.25|2.67|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.67|-0.25|0.104
71065643|NCT00529373|141640363|OTHER||Difference in Least Squares Means|1.55||||0.617|TWO_SIDED|95.0|-4.92|8.02|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||8.02|-4.92|0.617
71065644|NCT00529373|141640364|OTHER||Difference in Least Squares Means|-58.99|||<|0.001|TWO_SIDED|95.0|-64.68|-53.3|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6.||-53.30|-64.68|<0.001
71065645|NCT00529373|141640364|OTHER||Difference in Least Squares Means|-60.01|||<|0.001|TWO_SIDED|95.0|-66.4|-53.61|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12.||-53.61|-66.40|<0.001
71065646|NCT00529373|141640364|OTHER||Difference in Least Squares Means|-46.7|||<|0.001|TWO_SIDED|95.0|-53.23|-40.17|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24.||-40.17|-53.23|<0.001
71065647|NCT00529373|141640364|OTHER||Difference in Least Squares Means|-44.67||||0.05|TWO_SIDED|95.0|-52.62|-36.72|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36.||-36.72|-52.62|0.050
71065648|NCT00529373|141640364|OTHER||Difference in Least Squares Means|-18.73||||0.05|TWO_SIDED|95.0|-37.44|-0.01|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48.||-0.01|-37.44|0.050
71065649|NCT00529373|141640365|OTHER||Difference in Least Squares Means|-51.7|||<|0.001|TWO_SIDED|95.0|-56.11|-47.28|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6.||-47.28|-56.11|<0.001
71065650|NCT00529373|141640365|OTHER||Difference in Least Squares Means|-53.59|||<|0.001|TWO_SIDED|95.0|-58.39|-48.79|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12.||-48.79|-58.39|<0.001
71065651|NCT00529373|141640365|OTHER||Difference in Least Squares Means|-56.68|||<|0.001|TWO_SIDED|95.0|-62.52|-50.84|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24.||-50.84|-62.52|<0.001
71065652|NCT00529373|141640365|OTHER||Difference in Least Squares Means|-59.14|||<|0.001|TWO_SIDED|95.0|-66.04|-52.23|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36.||-52.23|-66.04|<0.001
71065653|NCT00529373|141640365|OTHER||Difference in Least Squares Means|-44.54|||<|0.001|TWO_SIDED|95.0|-61.72|-27.36|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48.||-27.36|-61.72|<0.001
71065654|NCT00529373|141640366|OTHER||Mean Difference (Final Values)|-14.13|||<|0.001|TWO_SIDED|95.0|-17.0|-11.27|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-11.27|-17.00|<0.001
71065655|NCT00529373|141640366|OTHER||Mean Difference (Final Values)|-12.01|||<|0.001|TWO_SIDED|95.0|-15.22|-8.79|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-8.79|-15.22|<0.001
71065656|NCT00529373|141640366|OTHER||Mean Difference (Final Values)|-9.29|||<|0.001|TWO_SIDED|95.0|-13.45|-5.13|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-5.13|-13.45|<0.001
71065657|NCT00529373|141640366|OTHER||Mean Difference (Final Values)|-7.64|||<|0.001|TWO_SIDED|95.0|-11.87|-3.41|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-3.41|-11.87|<0.001
71065658|NCT00529373|141640366|OTHER||Mean Difference (Final Values)|-0.77||||0.896|TWO_SIDED|95.0|-12.34|10.79|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||10.79|-12.34|0.896
71111494|NCT01082081|141729496|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.25|||<|0.0001|TWO_SIDED|95.0|4.04|10.45|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID\^6h between Paracetamol 1000 mg caplet and placebo caplet.||10.45|4.04|<0.0001
71111495|NCT01082081|141729496|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.48||||0.1307|TWO_SIDED|95.0|-0.74|5.69|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID\^6h between Paracetamol 500 mg caplet and placebo caplet.||5.69|-0.74|0.1307
71111496|NCT00932035|141729511|SUPERIORITY|To achieve a power of 0.84, a sample size of 72 patients, evenly distributed is required. With 36 patients per group, a Fisher's exact test with a one-sided alpha of 0.05 will have a 84% power to detect the difference between the experimental group (axillary reverse mapping) of 5% or less and a control group (standard dissection) of 30% or more. Response estimates were chosen based on reported lymphedema rates.||||||0.45|||||||Fisher Exact|||||||0.45
71111497|NCT00932035|141729512|SUPERIORITY|||||||0.5|||||||Fisher Exact|||||||0.50
71111498|NCT00932035|141729513|SUPERIORITY|||||||0.59|||||||Chi-squared|||||||0.59
71111499|NCT02709512|141729536|SUPERIORITY|Relative Risk Ratio (ADIPemPlatinum/PlaceboPemPlatinum) is the common relative risk of having a response (CR or PR) based on the Mantel-Haenszel estimator controlling for tumor histology. A relative risk ratio greater than one is favorable to ADIPemPlatinum.|Risk Ratio (RR)|1.02||||0.9489|TWO_SIDED|95.0|0.5|2.11|||Cochran-Mantel-Haenszel|||||2.11|0.50|0.9489
71111500|NCT02709512|141729537|SUPERIORITY||Cox Proportional Hazard|0.64||||0.0078|TWO_SIDED|95.0|0.47|0.88|||Log Rank|||||0.88|0.47|0.0078
71111501|NCT02709512|141729538|SUPERIORITY||Cox Proportional Hazard|0.71||||0.0234|TWO_SIDED|95.0|0.55|0.93|||Log Rank|||||0.93|0.55|0.0234
70852685|NCT01578850|141194332|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0||||0.766|TWO_SIDED|95.0|-1.69|1.65|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-ESR Week 24||1.65|-1.69|0.766
70852686|NCT01578850|141194332|SUPERIORITY_OR_OTHER||Difference in Proportions|8.2||||0.091|TWO_SIDED|95.0|2.32|14.1|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-ESR Week 28||14.10|2.32|0.091
70852687|NCT01578850|141194332|SUPERIORITY_OR_OTHER||Difference in proportions|6.5||||0.227|TWO_SIDED|95.0|1.28|11.75|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-CRP Week 28||11.75|1.28|0.227
70941770|NCT04748445|141383935|OTHER||Slope|2.393|STANDARD_ERROR_OF_MEAN|1.627||0.1439|TWO_SIDED|90.0|-3.035|5.09|||Mixed Models Analysis|||READ\_MFCC 1st order delta 07 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-4. For lower limit it was 10\^-5).||5.090|-3.035|0.1439
71111502|NCT02709512|141729539|SUPERIORITY||Cox Proportional Hazard|0.65||||0.0193|TWO_SIDED|95.0|0.46|0.9|||Log Rank|||||0.90|0.46|0.0193
71111503|NCT00600106|141729546|SUPERIORITY_OR_OTHER|All tests were two-sided with p values \<0.05.||||||0.36|||||||t-test (nonparametric Wilcoxon test)|||"Data were presented in tables as means and SDs for continuous variables and frequencies for categorical variables. Comparisons between the placebo and 1/10 NA/EE groups were don using Wilcoxon rank sum test for continuous measurement and Fisher's exact test for discrete data. The strategy of analysis was intention to treat with comparing the study groups in term of treatment to which they were randomly allocated."||||0.36
71111504|NCT00600106|141729547|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.93
71111505|NCT00600106|141729548|SUPERIORITY_OR_OTHER|All tests were two-sided with p values \<0.05.||||||0.77|||||||Wilcoxon rank sum test|||"Data were presented in tables as means and SDs for continuous variables and frequencies for categorical variables. Comparisons between the placebo and 1/10 NA/EE groups were don using Wilcoxon rank sum test for continuous measurement and Fisher's exact test for discrete data. The strategy of analysis was intention to treat with comparing the study groups in term of treatment to which they were randomly allocated."||||0.77
70852688|NCT01578850|141194332|SUPERIORITY_OR_OTHER||Difference in proportions|9.9||||0.072|TWO_SIDED|95.0|3.27|16.6|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-ESR Week 36||16.60|3.27|0.072
70852689|NCT01578850|141194332|SUPERIORITY_OR_OTHER||Difference in proportions|8.8||||0.108|TWO_SIDED|95.0|2.43|15.2|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-CRP Week 36||15.20|2.43|0.108
70941771|NCT04748445|141383935|OTHER||Slope|4.111|STANDARD_ERROR_OF_MEAN|1.553||0.0092|TWO_SIDED|90.0|1.537|6.685|||Mixed Models Analysis|||READ\_MFCC 1st order delta 08 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||6.685|1.537|0.0092
71065659|NCT00529373|141640367|OTHER||Mean Difference (Final Values)|-29.43|||<|0.001|TWO_SIDED|95.0|-33.47|-25.39|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-25.39|-33.47|<0.001
71065660|NCT00529373|141640367|OTHER||Mean Difference (Final Values)|-25.94|||<|0.001|TWO_SIDED|95.0|-30.54|-21.34|||Longitudinal|||Odanacatib 50 mg OW - Placebo at Month 12. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-21.34|-30.54|<0.001
71065661|NCT00529373|141640367|OTHER||Mean Difference (Final Values)|-16.26|||<|0.001|TWO_SIDED|95.0|-21.41|-11.12|||Longitudinal|||Odanacatib 50 mg OW - Placebo at Month 24. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-11.12|-21.41|<0.001
71065662|NCT00529373|141640367|OTHER||Mean Difference (Final Values)|-12.11|||<|0.001|TWO_SIDED|95.0|-18.03|-6.19|||Longitudinal|||Odanacatib 50 mg OW - Placebo at Month 36. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-6.19|-18.03|<0.001
71065663|NCT00529373|141640367|OTHER||Mean Difference (Final Values)|-3.34||||0.61|TWO_SIDED|95.0|-16.12|9.45|||Longitudinal|||Odanacatib 50 mg OW - Placebo at Month 48. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||9.45|-16.12|0.610
71065664|NCT00529373|141640368|OTHER||Hazard Ratio (HR)|1.12||||0.182|TWO_SIDED|95.0|0.95|1.34|||Regression, Cox|No adjustments for multiplicity were applied; p-value is unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.34|0.95|0.182
71065665|NCT00529373|141640369|OTHER||Hazard Ratio (HR)|1.18||||0.235|TWO_SIDED|95.0|0.9|1.55|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.55|0.9|0.235
71065666|NCT00529373|141640370|OTHER||Hazard Ratio (HR)|1.12||||0.127|TWO_SIDED|95.0|0.97|1.29|||Regression, Cox|No adjustments for multiplicity were applied; p-value is unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.29|0.97|0.127
71065667|NCT00529373|141640371|OTHER||Hazard Ratio (HR)|1.06||||0.857|TWO_SIDED|95.0|0.59|1.89|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.89|0.59|0.857
71065668|NCT00529373|141640372|OTHER||Hazard Ratio (HR)|1.1||||0.606|TWO_SIDED|95.0|0.76|1.59|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.59|0.76|0.606
71065669|NCT00529373|141640373|OTHER||Hazard Ratio (HR)|1.25||||0.074|TWO_SIDED|95.0|0.98|1.6|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.6|0.98|0.074
71065670|NCT00529373|141640374|OTHER||Hazard Ratio (HR)|1.12||||0.127|TWO_SIDED|95.0|0.97|1.29|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.29|0.97|0.127
71065671|NCT00529373|141640375|OTHER||Hazard Ratio (HR)|1.16||||0.277|TWO_SIDED|95.0|0.89|1.52|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.52|0.89|0.277
71065672|NCT00529373|141640376|OTHER||Hazard Ratio (HR)|0.82||||0.256|TWO_SIDED|95.0|0.58|1.15|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.15|0.58|0.256
71065673|NCT00529373|141640377|OTHER||Hazard Ratio (HR)|0.86||||0.794|TWO_SIDED|95.0|0.29|2.57|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||2.57|0.29|0.794
71065674|NCT00529373|141640378|OTHER||Hazard Ratio (HR)|1.32||||0.034|TWO_SIDED|95.0|1.02|1.7|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.7|1.02|0.034
71065675|NCT00529373|141640379|OTHER||Hazard Ratio (HR)|1.91||||0.081|TWO_SIDED|95.0|0.93|3.97|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||3.97|0.93|0.081
71065676|NCT00529373|141640380|OTHER||Difference in Least Squares Means|1.47|||<|0.001|TWO_SIDED|95.0|0.92|2.01|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.01|0.92|<0.001
71065677|NCT00529373|141640380|OTHER||Difference in Least Squares Means|2.21|||<|0.001|TWO_SIDED|95.0|2.05|2.37|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.37|2.05|<0.001
71065678|NCT00529373|141640380|OTHER||Difference in Least Squares Means|4.39|||<|0.001|TWO_SIDED|95.0|4.2|4.57|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.57|4.20|<0.001
71065679|NCT00529373|141640380|OTHER||Difference in Least Squares Means|6.5|||<|0.001|TWO_SIDED|95.0|6.28|6.72|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.72|6.28|<0.001
71065680|NCT00529373|141640380|OTHER||Difference in Least Squares Means|8.29|||<|0.001|TWO_SIDED|95.0|8.02|8.57|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||8.57|8.02|<0.001
70938221|NCT00689351|141376472|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.05|||||TWO_SIDED|95.0|0.78|1.4|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 23F: Ratio of geometric means (13vPnC, 7vPnC)||1.40|0.78|
70938222|NCT00689351|141376472|SUPERIORITY_OR_OTHER||Ratio of geometric means|234.33|||||TWO_SIDED|95.0|176.33|311.41|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 1: Ratio of geometric means (13vPnC, 7vPnC)||311.41|176.33|
70938223|NCT00689351|141376472|SUPERIORITY_OR_OTHER||Ratio of geometric means|16.63|||||TWO_SIDED|95.0|12.19|22.69|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 3: Ratio of geometric means (13vPnC, 7vPnC)||22.69|12.19|
70938224|NCT00689351|141376472|SUPERIORITY_OR_OTHER||Ratio of geometric means|6.84|||||TWO_SIDED|95.0|5.39|8.67|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 5: Ratio of geometric means (13vPnC, 7vPnC)||8.67|5.39|
70938225|NCT00689351|141376472|SUPERIORITY_OR_OTHER||Ratio of geometric means|4.08|||||TWO_SIDED|95.0|3.07|5.43|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 6A: Ratio of geometric means (13vPnC, 7vPnC)||5.43|3.07|
70938226|NCT00689351|141376472|SUPERIORITY_OR_OTHER||Ratio of geometric means|110.92|||||TWO_SIDED|95.0|77.09|159.59|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 7F: Ratio of geometric means (13vPnC, 7vPnC)||159.59|77.09|
70938227|NCT00689351|141376472|SUPERIORITY_OR_OTHER||Ratio of geometric means|4.25|||||TWO_SIDED|95.0|3.39|5.33|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 19A: Ratio of geometric means (13vPnC, 7vPnC)||5.33|3.39|
71065681|NCT00529373|141640380|OTHER||Difference in Least Squares Means|10.05|||<|0.001|TWO_SIDED|95.0|9.72|10.38|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||10.38|9.72|<0.001
71065682|NCT00529373|141640381|OTHER||Difference in Least Squares Means|1.1|||<|0.001|TWO_SIDED|95.0|0.66|1.54|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||1.54|0.66|<0.001
71065683|NCT00529373|141640381|OTHER||Difference in Least Squares Means|1.36|||<|0.001|TWO_SIDED|95.0|0.87|1.85|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||1.85|0.87|<0.001
71065684|NCT00529373|141640381|OTHER||Difference in Least Squares Means|1.96|||<|0.001|TWO_SIDED|95.0|1.42|2.5|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.50|1.42|<0.001
71065685|NCT00529373|141640381|OTHER||Difference in Least Squares Means|2.18|||<|0.001|TWO_SIDED|95.0|1.4|2.96|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.96|1.40|<0.001
71065686|NCT00529373|141640381|OTHER||Difference in Least Squares Means|2.33||||0.001|TWO_SIDED|95.0|1.54|3.11|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||3.11|1.54|0.001
70938228|NCT00689351|141376473|SUPERIORITY_OR_OTHER|||||||0.862|||||||Fisher Exact|||Comparison between treatments for any tenderness.||||0.862
70938229|NCT00689351|141376473|SUPERIORITY_OR_OTHER|||||||0.157|||||||Fisher Exact|||Comparison between treatments for significant tenderness.||||0.157
70938230|NCT00689351|141376473|SUPERIORITY_OR_OTHER|||||||0.55|||||||Fisher Exact|||Comparison between treatments for any swelling.||||0.550
71065687|NCT00529373|141640382|OTHER||Hazard Ratio (HR)|0.33|||<|0.001|TWO_SIDED|95.0|0.24|0.45|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. the Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.45|0.24|<0.001
71065688|NCT00529373|141640383|OTHER||Hazard Ratio (HR)|0.67|||<|0.001|TWO_SIDED|95.0|0.6|0.75|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.75|0.60|<0.001
71065689|NCT00529373|141640384|OTHER||Difference in Least Squares Means|1.34|||<|0.001|TWO_SIDED|95.0|0.94|1.74|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||1.74|0.94|<0.001
71065690|NCT00529373|141640384|OTHER||Difference in Least Squares Means|2.5|||<|0.001|TWO_SIDED|95.0|2.38|2.62|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.62|2.38|<0.001
71065691|NCT00529373|141640384|OTHER||Difference in Least Squares Means|4.47|||<|0.001|TWO_SIDED|95.0|4.31|4.62|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.62|4.31|<0.001
71065692|NCT00529373|141640384|OTHER||Difference in Least Squares Means|6.46|||<|0.001|TWO_SIDED|95.0|6.26|6.65|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.65|6.26|<0.001
71065693|NCT00529373|141640384|OTHER||Difference in Least Squares Means|8.48|||<|0.001|TWO_SIDED|95.0|8.24|8.73|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||8.73|8.24|<0.001
71065694|NCT00529373|141640384|OTHER||Difference in Least Squares Means|10.29|||<|0.001|TWO_SIDED|95.0|9.99|10.59|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||10.59|9.99|<0.001
71065695|NCT00529373|141640385|OTHER||Difference in Least Squares Means|1.74|||<|0.001|TWO_SIDED|95.0|1.06|2.42|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.42|1.06|<0.001
71065696|NCT00529373|141640385|OTHER||Difference in Least Squares Means|3.5|||<|0.001|TWO_SIDED|95.0|3.31|3.7|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||3.70|3.31|<0.001
71065697|NCT00529373|141640385|OTHER||Difference in Least Squares Means|6.41|||<|0.001|TWO_SIDED|95.0|6.16|6.65|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 24||6.65|6.16|<0.001
70852690|NCT01578850|141194332|SUPERIORITY_OR_OTHER||Difference in proportions|11.7||||0.035|TWO_SIDED|95.0|4.69|18.72|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-ESR Week 44||18.72|4.69|0.035
71065698|NCT00529373|141640385|OTHER||Difference in Least Squares Means|9.25|||<|0.001|TWO_SIDED|95.0|8.95|9.54|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||9.54|8.95|<0.001
71065699|NCT00529373|141640385|OTHER||Difference in Least Squares Means|12.14|||<|0.001|TWO_SIDED|95.0|11.76|12.51|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||12.51|11.76|<0.001
71065700|NCT00529373|141640385|OTHER||Difference in Least Squares Means|14.56|||<|0.001|TWO_SIDED|95.0|14.11|15.01|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||15.01|14.11|<0.001
71065701|NCT00529373|141640386|OTHER||Difference in Least Squares Means|2.9|||<|0.001|TWO_SIDED|95.0|2.4|3.39|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||3.39|2.40|<0.001
71065702|NCT00529373|141640386|OTHER||Difference in Least Squares Means|4.01|||<|0.001|TWO_SIDED|95.0|3.87|4.15|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.15|3.87|<0.001
71065703|NCT00529373|141640386|OTHER||Difference in Least Squares Means|5.93|||<|0.001|TWO_SIDED|95.0|5.75|6.11|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.11|5.75|<0.001
70938231|NCT00689351|141376473|SUPERIORITY_OR_OTHER|||||||0.052|||||||Fisher Exact|||Comparison between treatments for mild swelling.||||0.052
71065704|NCT00529373|141640386|OTHER||Difference in Least Squares Means|7.7|||<|0.001|TWO_SIDED|95.0|7.48|7.91|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||7.91|7.48|<0.001
71065705|NCT00529373|141640386|OTHER||Difference in Least Squares Means|9.34|||<|0.001|TWO_SIDED|95.0|9.08|9.61|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||9.61|9.08|<0.001
71065706|NCT00529373|141640386|OTHER||Difference in Least Squares Means|10.87|||<|0.001|TWO_SIDED|95.0|10.55|11.19|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||11.19|10.55|<0.001
71065707|NCT00529373|141640395|OTHER||Difference in Least Squares Means|2.76|||<|0.001|TWO_SIDED|95.0|1.43|4.1|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||4.10|1.43|<0.001
71065708|NCT00529373|141640396|OTHER||Difference in Least Squares Means|5.55|||<|0.001|TWO_SIDED|95.0|4.06|7.05|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||7.05|4.06|<0.001
71065709|NCT00529373|141640397|OTHER||Difference in Least Squares Means|2.79||||0.005|TWO_SIDED|95.0|0.86|4.72|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||4.72|0.86|0.005
71111506|NCT00600106|141729550|SUPERIORITY_OR_OTHER|All tests were two-sided with p values \<0.05.||||||0.38|||||||Wilcoxon rank sum test|||"Data were presented in tables as means and SDs for continuous variables and frequencies for categorical variables. Comparisons between the placebo and 1/10 NA/EE groups were don using Wilcoxon rank sum test for continuous measurement and Fisher's exact test for discrete data. The strategy of analysis was intention to treat with comparing the study groups in term of treatment to which they were randomly allocated."||||0.38
70938232|NCT00689351|141376473|SUPERIORITY_OR_OTHER|||||||0.366|||||||Fisher Exact|||Comparison between treatments for moderate swelling.||||0.366
70938233|NCT00689351|141376473|SUPERIORITY_OR_OTHER|||||||0.301|||||||Fisher Exact|||Comparison between treatments for any redness.||||0.301
71065710|NCT00529373|141640398|OTHER||Difference in Least Squares Means|3.63|||<|0.001|TWO_SIDED|95.0|2.35|4.9|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||4.90|2.35|<0.001
71065711|NCT00529373|141640399|OTHER||Difference in Least Squares Means|5.65|||<|0.001|TWO_SIDED|95.0|3.79|7.5|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||7.50|3.79|<0.001
71065712|NCT00529373|141640400|OTHER||Difference in Least Squares Means|-62.25|||<|0.001|TWO_SIDED|95.0|-79.99|-44.5|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||-44.50|-79.99|<0.001
71065713|NCT00529373|141640401|OTHER||Difference in Least Squares Means|-26.7||||0.001|TWO_SIDED|95.0|-42.56|-10.83|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||-10.83|-42.56|0.001
71111507|NCT00600106|141729554|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||t-test (nonparametric Wilcoxon test)|||"Data were presented in tables as means and SDs for continuous variables and frequencies for categorical variables. Comparisons between the placebo and 1/10 NA/EE groups were don using Wilcoxon rank sum test for continuous measurement and Fisher's exact test for discrete data. The strategy of analysis was intention to treat with comparing the study groups in term of treatment to which they were randomly allocated. All tests were two-sided with p values \<0.05."||||0.17
71065714|NCT00529373|141640402|OTHER||Difference in Least Squares Means|1.67||||0.016|TWO_SIDED|95.0|0.32|3.01|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||3.01|0.32|0.016
71065715|NCT00529373|141640403|OTHER||Difference in Least Squares Means|-25.02|||<|0.001|TWO_SIDED|95.0|-35.92|-14.12|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||-14.12|-35.92|<0.001
71065716|NCT00529373|141640404|OTHER||Difference in Least Squares Means|-64.43|||<|0.001|TWO_SIDED|95.0|-87.8|-41.07|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||-41.07|-87.80|<0.001
71065717|NCT00529373|141640405|OTHER||Difference in Least Squares Means|8.53|||<|0.001|TWO_SIDED|95.0|5.79|11.28|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||11.28|5.79|<0.001
71111508|NCT00600106|141729555|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.49
71111509|NCT00600106|141729556|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.77
71111510|NCT00600106|141729557|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.40
71111511|NCT00600106|141729558|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.99
70938234|NCT00689351|141376473|SUPERIORITY_OR_OTHER|||||||0.362|||||||Fisher Exact|||Comparison between treatments for mild redness.||||0.362
70938235|NCT00689351|141376473|SUPERIORITY_OR_OTHER|||||||0.718|||||||Fisher Exact|||Comparison between treatments for moderate redness.||||0.718
70938236|NCT00689351|141376474|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Fisher Exact|||Comparison between treatments for any tenderness.||||>0.99
70938237|NCT00689351|141376474|SUPERIORITY_OR_OTHER|||||||0.245|||||||Fisher Exact|||Comparison between treatments for significant tenderness.||||0.245
70938238|NCT00689351|141376474|SUPERIORITY_OR_OTHER|||||||0.447|||||||Fisher Exact|||Comparison between treatments for any swelling.||||0.447
70938239|NCT00689351|141376474|SUPERIORITY_OR_OTHER|||||||0.684|||||||Fisher Exact|||Comparison between treatments for mild swelling.||||0.684
70938240|NCT00689351|141376474|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Fisher Exact|||Comparison between treatments for moderate swelling.||||>0.99
71065718|NCT00529373|141640406|OTHER||Difference in Least Squares Means|11.08|||<|0.001|TWO_SIDED|95.0|8.41|13.74|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||13.74|8.41|<0.001
71065719|NCT00529373|141640407|OTHER||Difference in Least Squares Means|10.41|||<|0.001|TWO_SIDED|95.0|8.05|12.78|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||12.78|8.05|<0.001
71065720|NCT00529373|141640408|OTHER||Difference in Least Squares Means|9.98|||<|0.001|TWO_SIDED|95.0|6.91|13.06|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||13.06|6.91|<0.001
71065721|NCT00529373|141640409|OTHER||Difference in Least Squares Means|14.94|||<|0.001|TWO_SIDED|95.0|11.29|18.59|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||18.59|11.29|<0.001
71065722|NCT00529373|141640410|OTHER||Hazard Ratio (HR)|0.79||||0.366|TWO_SIDED|95.0|0.47|1.33|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.33|0.47|0.366
71065723|NCT00529373|141640411|OTHER||Hazard Ratio (HR)|1.13||||0.246|TWO_SIDED|95.0|0.92|1.4|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.4|0.92|0.246
71065724|NCT00529373|141640412|OTHER||Hazard Ratio (HR)|0.8||||0.638|TWO_SIDED|95.0|0.32|2.03|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||2.03|0.32|0.638
71065725|NCT00529373|141640413|OTHER||Hazard Ratio (HR)|1.17||||0.029|TWO_SIDED|95.0|1.02|1.36|||Regression, Cox|No adjustments for multiplicity were applied; p-value is unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.36|1.02|0.029
71065726|NCT00529373|141640414|OTHER||Hazard Ratio (HR)|1.05||||0.341|TWO_SIDED|95.0|0.95|1.17|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.17|0.95|0.341
71065727|NCT00529373|141640415|OTHER||Hazard Ratio (HR)|1.23||||0.198|TWO_SIDED|95.0|0.9|1.68|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.68|0.9|0.198
71111512|NCT00600106|141729559|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.21
71111513|NCT00252512|141729560|SUPERIORITY||||||<|0.001||||||Above is calculated p value, a priori threshold for significance set at \<.05|GEE full factorial modeling|||||||<.001
71111514|NCT00252512|141729561|SUPERIORITY|||||||0.015||||||a priori threshold of \<.05|t-test, 2 sided|||8 week analysis||||.015
70938241|NCT00689351|141376474|SUPERIORITY_OR_OTHER|||||||0.578|||||||Fisher Exact|||Comparison between treatments for any redness.||||0.578
71065728|NCT00529373|141640416|OTHER||Hazard Ratio (HR)|0.94||||0.798|TWO_SIDED|95.0|0.7|1.26|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.26|0.7|0.798
71065729|NCT00529373|141640417|OTHER||Hazard Ratio (HR)|1.37||||0.005|TWO_SIDED|95.0|1.1|1.71|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.71|1.1|0.005
71065730|NCT00529373|141640418|OTHER||Hazard Ratio (HR)|1.22||||0.059|TWO_SIDED|95.0|0.99|1.5|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.5|0.99|0.059
71065731|NCT00529373|141640419|OTHER||Hazard Ratio (HR)|1.61||||0.114|TWO_SIDED|95.0|0.89|2.9|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||2.9|0.89|0.114
71065732|NCT00529373|141640420|OTHER||Hazard Ratio (HR)|1.14||||0.159|TWO_SIDED|95.0|0.99|1.31|||Regression, Cox|No adjustments for multiplicity were applied; p-value is unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.31|0.99|0.159
71065733|NCT00529373|141640421|OTHER||Hazard Ratio (HR)|1.17||||0.178|TWO_SIDED|95.0|0.93|1.46|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.46|0.93|0.178
71065734|NCT00529373|141640422|OTHER|Miettinen \& Nurminen|Difference in rates|0.04|||||TWO_SIDED|95.0|-0.01|0.09||||||||0.09|-0.01|
71065735|NCT00529373|141640423|OTHER|Miettinen \& Nurminen|Difference in rates|0.02|||||TWO_SIDED|95.0|0.01|0.05||||||||0.05|0.01|
71065736|NCT00529373|141640424|OTHER|Miettinen \& Nurminen|Difference in rates|0.06|||||TWO_SIDED|95.0|0.03|0.11||||||||0.11|0.03|
71065737|NCT00529373|141640425|OTHER|Miettinen \& Nurminen|Difference in rates|0.03|||||TWO_SIDED|95.0|0.02|0.06||||||||0.06|0.02|
70938242|NCT00689351|141376474|SUPERIORITY_OR_OTHER|||||||0.451|||||||Fisher Exact|||Comparison between treatments for mild redness.||||0.451
70938243|NCT00689351|141376474|SUPERIORITY_OR_OTHER|||||||0.712|||||||Fisher Exact|||Comparison between treatments for moderate redness.||||0.712
70938244|NCT00689351|141376475|SUPERIORITY_OR_OTHER|||||||0.681|||||||Fisher Exact|||Comparison between treatments for any tenderness.||||0.681
71065738|NCT03627546|141640447|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||.01
71065739|NCT03627546|141640448|SUPERIORITY|||||||0.0007|||||||Chi-squared|||||||0.0007
71065740|NCT00961350|141640503|SUPERIORITY_OR_OTHER||Proportions|3.8||||0.02||95.0|1.8|6.8|||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.|The proportion is from the PA32540 treatment group.|The primary efficacy endpoint was the proportion of subjects with gastric ulcers throughout 6 months of treatment. The primary endpoint was analyzed with the CMH test stratified by NSAID use (COX-2/Other NSAID/No) at randomization. A sample size of 250 subjects/treatment would provide 86% power to detect the difference of 8% between EC aspirin 325 mg (13%) and PA32540 (5%) with a 2-sided significance of 5%; and, provides adequate power to test the key secondary endpoints in sequential order.||6.8|1.8|0.020
71065741|NCT00961350|141640504|SUPERIORITY_OR_OTHER|||||||0.002|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects developing gastric ulcers and/or duodenal ulcers at 6 months was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||0.002
71065742|NCT00961350|141640505|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects with Treatment Success was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||<0.001
71065743|NCT00961350|141640506|SUPERIORITY_OR_OTHER|||||||0.002|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects discontinuing from the study due to NSAID-associated upper GI adverse events was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||0.002
71065744|NCT00961350|141640507|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO and by baseline heartburn severity at randomization.||The proportion of subjects who had no heartburn at 6 months (regardless of the presence or absence of heartburn at baseline) was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||<0.001
71065745|NCT01022307|141640516|NON_INFERIORITY_OR_EQUIVALENCE|Power analysis showed that the effect size was small, with a 50% chance of detecting a p \< 0.05 effect requiring 247 subjects.|||||<|0.04|TWO_SIDED||||||F-test|Greenhouse Geisser correction.||F-test evaluating effects of Group||||< 0.04
71065746|NCT05253573|141640547|SUPERIORITY||Risk Ratio (RR)|1.85|||||TWO_SIDED|95.0|1.21|2.83||||||The overall number of participants analyzed reflects the cancer survivors and/or independent caregivers. Participants are not represented separately (as cancer survivors or caregivers) for each Arm. This is because the originally proposed statistical data analysis plan did not aim to analyze the data by each group of caregivers versus cancer patients/survivors (because the statistical power would be very low for doing so||2.83|1.21|
71065747|NCT00300885|141640569|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.915||95.0|0.94|1.41||According to protocol specified O'Brien-Fleming type alpha spending function and 384 deaths at interim analysis (IA), one-sided alpha value for IA was 0.0046.|Log Rank||Two treatment groups compared using one-sided log-rank test (Sorafenib+C/P over Placebo+C/P) with overall alpha of 0.025 stratified by same stratification factors as randomization|Sample size based on primary efficacy endpoint of OS. Clinically meaningful improvement defined as 30% improvement in median OS (i.e. HR of 0.76923, Sorafenib+C/P over Placebo+C/P -Null: theta\>=1, Alternative: theta\<=0.76923). With overall one-sided alpha of 0.025, 90% power and randomization of 1:1, one formal interim analysis and one final analysis were planned using O'Brien-Fleming type error spending function, and a total of 614 events (deaths) were required.||1.41|0.94|0.915
71065748|NCT00300885|141640570|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.433||95.0|0.84|1.16|||Log Rank|||Two treatment groups compared using one-sided log-rank test (Sorafenib+C/P over Placebo+C/P) with alpha of 0.025 stratified by same stratification factors at randomization||1.16|0.84|0.433
70938245|NCT00689351|141376475|SUPERIORITY_OR_OTHER|||||||0.482|||||||Fisher Exact|||Comparison between treatments for significant tenderness.||||0.482
71111515|NCT00252512|141729561|SUPERIORITY|||||||0.45||||||a priori threshold of \<.05|t-test, 2 sided|||6 month analysis||||0.45
71111516|NCT00252512|141729561|SUPERIORITY|||||||0.0497||||||a prior threshold of .05|t-test, 2 sided|||12 month analysis||||.0497
71111517|NCT00252512|141729562|SUPERIORITY||||||>|0.05||||||a priori threshold \<.05|Estimation Equation mean modeling|||Costs for period between 6 month follow-up and 12 month follow up.||||>.05
71111518|NCT00252512|141729562|SUPERIORITY||||||>|0.05|||||||Estimating Equation mean modeling|||Costs for period between 6 month follow up and 12 month follow up.||||>.05
71111519|NCT00252512|141729563|SUPERIORITY|||||||0.28||||||a priori threshold \<.05|Chi-squared|||Analysis for 8 week follow up||||.28
71111520|NCT00252512|141729563|SUPERIORITY|||||||0.013||||||A priori threshold \<.05|Chi-squared|||Analysis for 6 month follow up||||.013
71111521|NCT00252512|141729563|SUPERIORITY|||||||0.76||||||A priori threshold \<.05|Chi-squared|||Analysis for 12 month follow up||||.76
71111522|NCT00252512|141729564|SUPERIORITY|||||||0.66||||||A priori threshold \<.05|Chi-squared|||Analysis for 8 week follow-up||||.66
71111523|NCT00252512|141729564|SUPERIORITY|||||||0.37||||||A priori threshold \<.05|Chi-squared|||Analysis for 6 month follow up.||||.37
71111524|NCT00252512|141729564|SUPERIORITY|||||||0.19||||||a priori threshold \<.05|Chi-squared|||Analysis for 12 month follow up.||||.19
71111525|NCT00252512|141729565|SUPERIORITY|||||||0.05||||||A priori threshold of \<.05|Chi-squared|||Analysis for 8 week follow-up||||.05
71111526|NCT00252512|141729565|SUPERIORITY|||||||0.8||||||A priori threshold of \<.05|Chi-squared|||Analysis for 6 month follow-up.||||.80
70852691|NCT01578850|141194332|SUPERIORITY_OR_OTHER||Difference in proportions|10.6||||0.03|TWO_SIDED|95.0|4.2|17.06|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-ESR Week 44||17.06|4.20|0.030
71111527|NCT00252512|141729565|SUPERIORITY|||||||0.12||||||A priori threshold of \<.05|Chi-squared|||Analysis for 12 month follow-up.||||.12
71111528|NCT01665911|141729575|SUPERIORITY_OR_OTHER|||||||0.049||||||Non-fluoridated milk, 200 ml vs. 1.5 mg Sodium Fluoride in 100 ml milk|ANOVA|||Based on prior studies using a variety of products in this model, the within-product standard deviation of %SMH recovery is estimated to be 13% and the correlation between products is expected to be approximately 0.5. With a sample size of 28 subjects in a 5-way crossover study, the study will have 80% power to detect a %SMH recovery difference of 8.6%, assuming two-sided tests each conducted at a 5% significance level.||||0.0490
71111529|NCT01665911|141729575|SUPERIORITY_OR_OTHER|||||||0.19||||||Non-fluoridated milk, 200 ml vs. 1.5 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.19
71111530|NCT01665911|141729575|SUPERIORITY_OR_OTHER|||||||0.0017||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0017
71111531|NCT01665911|141729575|SUPERIORITY_OR_OTHER|||||||0.0092||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0092
70852692|NCT01578850|141194332|SUPERIORITY_OR_OTHER||Difference in proportions|11.1||||0.048|TWO_SIDED|95.0|4.15|18.06|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-ESR Week 52||18.06|4.15|0.048
70938246|NCT00689351|141376475|SUPERIORITY_OR_OTHER|||||||0.683|||||||Fisher Exact|||Comparison between treatments for any swelling.||||0.683
70938247|NCT00689351|141376475|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Fisher Exact|||Comparison between treatments for mild swelling.||||>0.99
70938248|NCT00689351|141376475|SUPERIORITY_OR_OTHER|||||||0.533|||||||Fisher Exact|||Comparison between treatments for moderate swelling.||||0.533
71111532|NCT01665911|141729575|SUPERIORITY_OR_OTHER|||||||0.45||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 1.5 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.45
71111533|NCT01665911|141729575|SUPERIORITY_OR_OTHER|||||||0.18||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.18
71111534|NCT01665911|141729575|SUPERIORITY_OR_OTHER|||||||0.47||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.47
71111535|NCT01665911|141729575|SUPERIORITY_OR_OTHER|||||||0.0423||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0423
71111536|NCT01665911|141729575|SUPERIORITY_OR_OTHER|||||||0.15||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.15
71111537|NCT01665911|141729575|SUPERIORITY_OR_OTHER|||||||0.54||||||3 mg sodium fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.54
71111538|NCT01665911|141729576|SUPERIORITY_OR_OTHER|||||||0.24||||||Non-fluoridated milk, 200 ml vs. 1.5 mg Sodium Fluoride in 100 ml milk|ANOVA|||||||0.24
71111539|NCT01665911|141729576|SUPERIORITY_OR_OTHER|||||||0.17||||||Non-fluoridated milk, 200 ml vs. 1.5 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.17
71111540|NCT01665911|141729576|SUPERIORITY_OR_OTHER|||||||0.0008||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0008
71111541|NCT01665911|141729576|SUPERIORITY_OR_OTHER|||||||0.0003||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0003
71111542|NCT01665911|141729576|SUPERIORITY_OR_OTHER|||||||0.24||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 1.5 mg Sodium Fluoride in 200 ml milk|ANOVA|||||||0.24
71111543|NCT01665911|141729576|SUPERIORITY_OR_OTHER|||||||0.26||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.26
71111544|NCT01665911|141729576|SUPERIORITY_OR_OTHER|||||||0.18||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.18
71111545|NCT01665911|141729576|SUPERIORITY_OR_OTHER|||||||0.0269||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0269
71111546|NCT01665911|141729576|SUPERIORITY_OR_OTHER|||||||0.0142||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0142
71111547|NCT01665911|141729576|SUPERIORITY_OR_OTHER|||||||0.81||||||3 mg sodium fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.81
71111548|NCT01665911|141729577|SUPERIORITY_OR_OTHER|||||||0||||||Non-fluoridated milk, 200 ml vs. 1.5 mg Sodium Fluoride in 100 ml milk|ANOVA|||||||0.0000
71111549|NCT01665911|141729577|SUPERIORITY_OR_OTHER|||||||0||||||Non-fluoridated milk, 200 ml vs. 1.5 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0000
71065749|NCT00300885|141640571|SUPERIORITY_OR_OTHER||difference in response rate (CR+PR rate)|-3.65||||0.1015||95.0|-9.18|1.89||no adjustments|Cochran-Mantel-Haenszel||difference in response rates (Complete Response (CR) + Partial Response (PR)) = Placebo+C/P - Sorafenib+C/P|Objective response rate (ie. CR+PR rate) was compared between treatment arms using Cochran-Mantel-Haenszel test with one-side alpha 0.025 adjusting for same stratification factors as randomization||1.89|-9.18|0.1015
71065750|NCT02582242|141640575|OTHER||Treatment difference at week 24|-0.09||||0.2601|TWO_SIDED|95.0|-0.23|0.06|||Mixed model for repeated measurements||Treatment difference at week 24: BIAsp 30 (TID) - BIAsp 30 (BID). Number of subjects contributed to the statistical analysis: N=217 for BIAsp 30 (TID) and N=213 for BIAsp 30 (BID).|The analysis was based on a mixed-effect model for repeated measures including changes from baseline in HbA1c at visit 6, 10, 14, 18, 22 and 26 (in week 4, 8, 12, 16, 20 and 24, respectively). The model included treatment, strata and region as fixed factors, subject as random effect, baseline HbA1c as covariate and interaction between all fixed effects and visit, and between the covariate and visit.||0.06|-0.23|0.2601
71065751|NCT00603902|141640593|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio, log|2.69|||<|0.0001|TWO_SIDED|95.0|2.31|3.13|||Regression, Logistic|Adjustments for baseline body weight.||||3.13|2.31|<0.0001
71065752|NCT00603902|141640594|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.0|||<|0.0001|TWO_SIDED|95.0|-3.44|-2.56|||ANCOVA|||||-2.56|-3.44|<0.0001
71065753|NCT00459290|141640600|SUPERIORITY_OR_OTHER|||||||0.7912|||||||Log Rank|||||||0.7912
71065754|NCT00459290|141640601|SUPERIORITY_OR_OTHER|||||||0.1545|||||||Log Rank|||||||0.1545
71065755|NCT00459290|141640602|SUPERIORITY_OR_OTHER|||||||0.0648|||||||Log Rank|||||||0.0648
71065756|NCT06110494|141640660|OTHER|Pairwise comparisons were done using Mann-Whitney U test of log10 transformed CFU reduction data to compare the antimicrobial effectiveness.||||||0.05||||||Pairwise comparisons were done using Mann-Whitney U test of log 10 transformed data to compare the antimicrobial effectiveness of Fer/H2O2 in comparison with the negative (saline) and positive (NaOCl) controls with P values set at \< 0.05|Wilcoxon (Mann-Whitney)|||The sample size estimate was calculated in Pass Software 2021, using a test that compares the ratio of two means from independent samples using data that has been log-normalized. An alpha of 0.05 and power of 80% was assumed, with means and standard deviations pulled from previous studies that employed similar methodology. This produced a required sample size of 16 for each group. Pairwise comparisons were done using Mann-Whitney U test to compare the antimicrobial effectiveness.||||0.05
71065757|NCT03612596|141640698|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||||||0.94
71065758|NCT03612596|141640699|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||||||0.88
71065759|NCT03612596|141640700|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||||||0.94
71065760|NCT03612596|141640701|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
71065761|NCT03612596|141640702|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
71065762|NCT03612596|141640703|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|Please note that this analysis was not powered and was used to characterize effect size (d = 1.26) rather than test efficacy.||||||0.53
71111550|NCT01665911|141729577|SUPERIORITY_OR_OTHER|||||||0||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0000
71065763|NCT03612596|141640704|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|Please note that this analysis was not powered and was used to characterize effect size (d = 1.16) rather than test efficacy.||||||0.44
71065764|NCT03612596|141640705|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|Please note that this analysis was not powered and was used to characterize effect size (d = 0.67) rather than test efficacy.||||||0.93
71065765|NCT03612596|141640706|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||||||0.29
71065766|NCT03612596|141640707|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||||||0.16
71065767|NCT03612596|141640708|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
71065768|NCT03612596|141640709|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.70
71065769|NCT03612596|141640710|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||||||0.71
71065770|NCT02573181|141640717|OTHER|Difference in percentage with AEs|Difference|4.2|||||TWO_SIDED|95.0|-7.4|15.8|||||Difference and 95% CI calculated based on Miettinen \& Nurminen method.|||15.8|-7.4|
71065771|NCT02573181|141640719|OTHER|Difference in % with fatigue|Fatigue difference|-0.9|||||TWO_SIDED|95.0|-10.7|8.8|||||Difference and 95% CI calculated based on the Miettinen \& Nurminen method.|||8.8|-10.7|
71065772|NCT02573181|141640719|OTHER|Difference in % with arthralgia|Arthralgia difference|-3.2|||||TWO_SIDED|95.0|-10.2|3.4|||||Difference and 95% CI calculated based on the Miettinen \& Nurminen method.|||3.4|-10.2|
71065773|NCT02573181|141640719|OTHER|Difference in % with myalgia|Myalgia difference|4.6|||||TWO_SIDED|95.0|-3.9|13.3|||||Difference and 95% CI calculated based on the Miettinen \& Nurminen method.|||13.3|-3.9|
71065774|NCT02573181|141640719|OTHER|Difference in % with headache|Headache difference|-2.5|||||TWO_SIDED|95.0|-11.4|6.4|||||Difference and 95% CI calculated based on the Miettinen \& Nurminen method.|||6.4|-11.4|
71065775|NCT03421210|141640726|OTHER|||||||0.001|||||||t-test, 1 sided|||Differences in brain activation in response to personal smoking versus standard smoking cues were examined.||||0.001
71065776|NCT03777436|141640740|SUPERIORITY||Adjusted difference|20.1||||0.0003|TWO_SIDED|95.0|9.2|30.9|||Cochran-Mantel-Haenszel||Adjusted difference is the weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights. 2-sided 95% CIs based on the stratified Newcombe method. Two-sided p-values were based on the CMH test.|||30.9|9.2|0.0003
71065777|NCT03777436|141640741|SUPERIORITY||Adjusted difference|15.2||||0.0004|TWO_SIDED|95.0|6.9|23.6|||Cochran-Mantel-Haenszel||Adjusted difference is the weighted average of the treatment differences across the strata with the CMH weights. 2-sided 95% CIs based on the stratified Newcombe method. Two-sided p-values were based on the CMH test.|||23.6|6.9|0.0004
71065778|NCT03777436|141640742|SUPERIORITY||Adjusted difference|27.4|||<|0.0001|TWO_SIDED|95.0|15.4|39.3|||Cochran-Mantel-Haenszel||Adjusted difference is the weighted average of the treatment differences across the strata with the CMH weights. 2-sided 95% CIs based on the stratified Newcombe method. Two-sided p-values were based on the CMH test.|||39.3|15.4|<0.0001
71065779|NCT03777436|141640743|SUPERIORITY||Least squares mean difference|-3.33|STANDARD_ERROR_OF_MEAN|0.942||0.0005|TWO_SIDED|95.0|-5.18|-1.47|||MMRM||Based on MMRM model.|||-1.47|-5.18|0.0005
71111551|NCT01665911|141729577|SUPERIORITY_OR_OTHER|||||||0||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0000
71065780|NCT03777436|141640744|SUPERIORITY||Least squares mean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.79||0.0008|TWO_SIDED|95.0|-4.2|-1.1|||MMRM||Based on MMRM model.|||-1.1|-4.2|0.0008
71065781|NCT03777436|141640745|SUPERIORITY||Difference|-15.1|STANDARD_ERROR_OF_MEAN|2.6|<|0.0001|TWO_SIDED|95.0|-20.3|-10.0|||MMRM||Based on MMRM model.|||-10.0|-20.3|<0.0001
71065782|NCT01342770|141640751|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Wilcoxon Signed Rank|||||||0.06
71065783|NCT02347774|141640788|SUPERIORITY|A sample size of 215 subjects per treatment would give \~ 90% power to detect a treatment difference of 80 mL in the change from baseline in trough FEV1 at Week 12 between each of the 2 SUN-101 dose groups and placebo at alpha= 0.05, assuming a standard deviation of 255 mL and using a 2-sided test.|Least Mean Squared (SE)|0.0736|STANDARD_ERROR_OF_MEAN|0.01989||0.0002|TWO_SIDED|95.0|0.0346|0.1127|||Least Mean Squared (SE)||In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|The change from baseline in trough FEV1 was analyzed using a mixed model repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1127|0.0346|0.0002
71065784|NCT02347774|141640788|SUPERIORITY|A sample size of 215 subjects per treatment would give \~ 90% power to detect a treatment difference of 80 mL in the change from baseline in trough FEV1 at Week 12 between each of the 2 SUN-101 dose groups and placebo at alpha= 0.05, assuming a standard deviation of 255 mL and using a 2-sided test.|Least Mean Squared (SE)|0.081|STANDARD_ERROR_OF_MEAN|0.02006||0.0001|TWO_SIDED|95.0|0.0416|0.1204|||Least Mean Squared (SE)||In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|The change from baseline in trough FEV1 was analyzed using a mixed model repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1204|0.0416|0.0001
71065785|NCT02347774|141640789|SUPERIORITY||Least Mean Squared (SE)|0.082|STANDARD_ERROR_OF_MEAN|0.02055|<|0.0001|TWO_SIDED|95.0|0.0417|0.1224||In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|Least Mean Squared (SE)|I||The change from baseline in trough FEV1 was analyzed using a mixed model repeated measures model including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1224|0.0417|<0.0001
71065786|NCT02347774|141640789|SUPERIORITY||Least Mean Squared (SE)|0.084|STANDARD_ERROR_OF_MEAN|0.02069||0.0001|TWO_SIDED|95.0|0.0433|0.1246||In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|Least Mean Squared (SE)|||The change from baseline in trough FEV1 was analyzed using a mixed model repeated measures model including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1246|0.0433|0.0001
71065787|NCT00921557|141640810|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Comparison of percent change from baseline to week 24||||<0.001
71065788|NCT00921557|141640810|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||Comparison of percent change from baseline to week 48||||<0.001
71065789|NCT00921557|141640811|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||||||Not adjusted for multiple comparisons|Fisher Exact|||Comparison of percentage of participants experiencing primary safety outcome||||>0.99
71065790|NCT01303172|141640884|OTHER||Cox Proportional Hazard|0.54||||0.011|TWO_SIDED|95.0|0.33|0.87|||Log Rank|||The difference between the two treatment groups was tested with a two-sided log-rank test and a Cox regression model was used to estimate the hazard ratio (HR) and its 95% CI and associated p-value.||0.87|0.33|0.011
71065791|NCT04468347|141640895|OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED||||||ANOVA|The two-way ANOVA included cognitive and amyloid status, and their interaction as fixed effects.||||||<0.0001
71065792|NCT04468347|141640895|OTHER||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.038||0.0005|TWO_SIDED||||||ANOVA|The two-way ANOVA included cognitive and amyloid status, and their interaction as fixed effects.||||||0.0005
70852693|NCT01578850|141194332|SUPERIORITY_OR_OTHER||Difference in proportions|11.2||||0.016|TWO_SIDED|95.0|4.92|17.58|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-CRP Week 52||17.58|4.92|0.016
70852694|NCT01578850|141194334|SUPERIORITY_OR_OTHER||Difference in proportions|0.6||||0.358|TWO_SIDED|95.0|-0.59|1.81|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: LDA Baseline||1.81|-0.59|0.358
70938249|NCT00689351|141376475|SUPERIORITY_OR_OTHER|||||||0.692|||||||Fisher Exact|||Comparison between treatments for any redness.||||0.692
71065793|NCT04468347|141640895|OTHER||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.033||0.2161|TWO_SIDED||||||ANOVA|The two-way ANOVA included cognitive and amyloid status, and their interaction as fixed effects.||||||0.2161
71065794|NCT04468347|141640896|OTHER|||||||0.1998|||||||Cochran-Mantel-Haenszel|||||||0.1998
71065795|NCT04468347|141640897|OTHER|||||||0.0646|||||||Cochran-Mantel-Haenszel|||||||0.0646
71065796|NCT00554515|141640898|SUPERIORITY|Comparison against historical control ORR of 14%.||||||0.042|||||||exact binomial test|||||||0.042
71065797|NCT00554515|141640899|SUPERIORITY|||||||0.39|||||||Fisher Exact|||Objective response rates were compared between ISM good and poor risk subgroups. ISM good risk ORR reported under primary endpoint.||||0.39
71065798|NCT00554515|141640900|SUPERIORITY|||||||0.0014|||||||exact binomial test|||Test against the historical ORR was conducted in the overall study population as secondary analyses.||||0.0014
71065799|NCT00554515|141640903|SUPERIORITY|||||||0.89|||||||Fisher Exact|||Objective response rates were compared between MSKCC subgroups.||||.89
71065800|NCT00554515|141640905|SUPERIORITY|||||||0.33|||||||Fisher Exact|||Objective response rates were compared between tumor type subgroups||||.33
71111552|NCT01665911|141729577|SUPERIORITY_OR_OTHER|||||||0.14||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 1.5 mg Sodium Fluoride in 200 ml milk|ANOVA|||||||0.14
71111553|NCT01665911|141729577|SUPERIORITY_OR_OTHER|||||||0.0012||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0012
71111554|NCT01665911|141729577|SUPERIORITY_OR_OTHER|||||||0.19||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.19
71111555|NCT01665911|141729577|SUPERIORITY_OR_OTHER|||||||0||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0000
71111556|NCT01665911|141729577|SUPERIORITY_OR_OTHER|||||||0.0075||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0075
71111557|NCT01665911|141729577|SUPERIORITY_OR_OTHER|||||||0.0444||||||3 mg sodium fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0444
71111558|NCT00770562|141729600|SUPERIORITY_OR_OTHER|||||||0.004|||||||Fisher Exact|||||||0.004
71111559|NCT00770562|141729601|SUPERIORITY_OR_OTHER|||||||0.001|||||||Fisher Exact|||||||0.001
71111560|NCT00770562|141729602|SUPERIORITY_OR_OTHER|||||||0.015|||||||Fisher Exact|||||||0.015
71111561|NCT01816776|141729603|SUPERIORITY||Risk Difference (RD)|41.0|||<|0.0001|TWO_SIDED|95.0|25.0|54.0||1-sided. p\<0.025 considered significant.|Fisher Exact||Risk difference = Treatment - Control|||54|25|<0.0001
71111562|NCT01816776|141729605|SUPERIORITY||Mean Difference (Net)|-22.8|||<|0.0001|TWO_SIDED|95.0|-29.0|-16.6||1-sided. Secondary endpoints hierarchically tested with p\<0.025 considered significant.|Wilcoxon (Mann-Whitney)||Mean difference = Treatment - Control|||-16.6|-29.0|<0.0001
71111563|NCT01816776|141729606|SUPERIORITY||Mean Difference (Net)|-25.0|||<|0.0001|TWO_SIDED|95.0|-31.2|-18.7||Secondary endpoints hierarchically tested with p\<0.025 considered significant.|t-test, 1 sided||Mean difference = Treatment - Control|||-18.7|-31.2|<0.0001
71111564|NCT01816776|141729607|SUPERIORITY||Mean Difference (Net)|-15.2|||<|0.0001|TWO_SIDED|95.0|-21.6|-8.7||Secondary endpoints hierarchically tested with p\<0.025 considered significant.|t-test, 1 sided||Mean difference = Treatment - Control|||-8.7|-21.6|<0.0001
71111565|NCT01816776|141729608|SUPERIORITY||Mean Difference (Net)|2.4||||0.0244|TWO_SIDED|95.0|-0.4|5.1||1-sided. Secondary endpoints hierarchically tested with p\<0.025 considered significant.|Wilcoxon (Mann-Whitney)||Mean difference = Treatment - Control|||5.1|-0.4|0.0244
70852695|NCT01578850|141194334|SUPERIORITY_OR_OTHER||Difference in proportions|3.4||||0.341|TWO_SIDED|95.0|-2.38|9.16|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: LDA: Week 24||9.16|-2.38|0.341
71111566|NCT01816776|141729609|SUPERIORITY||Risk Difference (RD)|55.0|||<|0.0001|TWO_SIDED|95.0|40.0|68.0||1-sided. Secondary endpoints hierarchically tested with p\<0.025 considered significant.|Fisher Exact||Risk difference = Treatment - Control|||68|40|<0.0001
71111567|NCT01816776|141729610|SUPERIORITY||Mean Difference (Net)|-22.7|||<|0.0001|TWO_SIDED|95.0|-28.9|-16.5||Secondary endpoints hierarchically tested with p\<0.025 considered significant.|t-test, 1 sided||Mean difference = Treatment - Control|||-16.5|-28.9|<0.0001
71111568|NCT01816776|141729611|SUPERIORITY||Mean Difference (Net)|-3.7|||<|0.0001|TWO_SIDED|95.0|-5.5|-2.0||1-sided. Secondary endpoints hierarchically tested with p\<0.025 considered significant.|Wilcoxon (Mann-Whitney)||Mean difference = Treatment - Control|||-2.0|-5.5|<0.0001
71111569|NCT01057693|141729620|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.32||||0.1221|TWO_SIDED|95.0|-0.74|0.09|||ANCOVA|||P-value was calculated using analysis of covariance (ANCOVA), with terms for baseline mean pain score, center and treatment in the model.||0.09|-0.74|0.1221
71111570|NCT00237666|141729647|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
70852696|NCT01578850|141194334|SUPERIORITY_OR_OTHER||Difference in proportions|18.3||||0.004|TWO_SIDED|95.0|8.4|28.27|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: LDA: Week 28||28.27|8.40|0.004
71111571|NCT00363142|141729671|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of FPV/r100 to FPV/r200 would be declared if the lower limit of the 2-sided 95% confidence interval on the difference in percentage of participants not meeting the virologic failure definition \[FPV/r100 minus FPV/r200\] was -12% or greater.|Difference in the percentages|-2.12||||||95.0|-9.36|5.12|||||Difference in percentages = percentage in Arm 1 minus percentage in Arm 2|||5.12|-9.36|
71111572|NCT01313910|141729694|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxin-rank test used to determine decrease in bowel movements/day after 8 weeks of intervention||||0.008
71111573|NCT01313910|141729695|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
71111574|NCT01313910|141729696|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71111575|NCT01313910|141729698|SUPERIORITY_OR_OTHER|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
71111576|NCT01340664|141729709|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.098|<|0.001|TWO_SIDED|95.0|-0.637|-0.251|||ANCOVA|||||-0.251|-0.637|<0.001
71111577|NCT01340664|141729709|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.098|<|0.001|TWO_SIDED|95.0|-0.792|-0.407|||ANCOVA|||||-0.407|-0.792|<0.001
71111578|NCT01340664|141729710|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-23.6|STANDARD_ERROR_OF_MEAN|4.673|<|0.001|TWO_SIDED|95.0|-32.78|-14.38|||ANCOVA|||||-14.38|-32.78|<0.001
71111579|NCT01340664|141729710|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-24.0|STANDARD_ERROR_OF_MEAN|4.661|<|0.001||95.0|-33.18|-14.83|||ANCOVA|||||-14.83|-33.18|<0.001
71111580|NCT01340664|141729711|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.1|-1.3|||ANCOVA|||||-1.3|-3.1|<0.001
71111581|NCT01340664|141729711|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.5|-1.7|||ANCOVA|||||-1.7|-3.5|<0.001
71111582|NCT01340664|141729712|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.43||||0.013|TWO_SIDED|95.0|1.21|4.9|||Regression, Logistic|||||4.90|1.21|0.013
71111583|NCT01340664|141729712|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.38|||<|0.001|TWO_SIDED|95.0|1.68|6.81|||Regression, Logistic|||||6.81|1.68|<0.001
71111584|NCT01926444|141729723|OTHER|||||||0.506|||||||ANOVA|||AUC- censorsed (standardized); FAS||||0.506
71111585|NCT01926444|141729723|OTHER|||||||0.299|||||||ANOVA|||AUC LOCF (standardized); FAS||||0.299
71111586|NCT01926444|141729723|OTHER|||||||0.234|||||||ANOVA|||AUC Censored (Standardized)- PP Population||||0.234
71111587|NCT01926444|141729723|OTHER|||||||0.219|||||||ANOVA|||AUC LOCF (Standardized)- PP Population||||0.219
71111588|NCT01926444|141729724|OTHER|||||||0.047|||||||Chi-squared|||Time to Caecum||||0.047
71111589|NCT01926444|141729725|OTHER|||||||0.047|||||||Chi-squared|||||||0.047
71111590|NCT01637584|141729768|SUPERIORITY_OR_OTHER||||||<|0.001||||||Threshold for significance: \<.05|Full Factorial ANOVAs and Paired T-tests|||Wakefulness \> Non-Rapid Eye Movement (NREM): Mean K-cluster voxels (Ke)=15,586: x,y,z= -36, -74, 0. Left Brodmann's Area (BA) 3, 6, 7, 10, 17, 19, 20,21,23, 38||||<0.001
71111591|NCT01637584|141729768|SUPERIORITY_OR_OTHER|||||||0.039||||||Threshold for significance: \<.05|Full Factorial ANOVAs and Paired T-tests|||Wakefulness \< NREM: Ke=7,013: x,y,z= 26, 22, -40. Right BA 4, 10-14, 21, 25, 32, 38, 45;||||0.039
71111592|NCT01637584|141729768|SUPERIORITY_OR_OTHER|||||||0.701||||||Threshold for significance: \<.05|Full Factorial ANOVAs and Paired T-tests|||Wakefulness \> (Rapid Eye Movement (REM): No cluster size, coordinates, or brain regions to report||||0.701
71111593|NCT01637584|141729768|SUPERIORITY_OR_OTHER|||||||1||||||Threshold for significance: \<.05|Full Factorial ANOVAs and Paired T-tests|||Wakefulness \< REM: No cluster size, coordinates, or brain regions to report||||1.00
71111594|NCT01637584|141729768|SUPERIORITY_OR_OTHER|||||||0.03||||||Threshold for significance: \<.05|Full Factorial ANOVAs and Paired T-tests|||Within-state decrease in rCMRglc: Ke=6,150: x,y,z= -30, -30, 2. Left BA 40, insula, hippocampus, caudate, and putamen;||||0.03
71111595|NCT01637584|141729768|SUPERIORITY_OR_OTHER|||||||0.01||||||Threshold for significance: \<.05|Full Factorial ANOVAs and Paired T-tests|||Within-state increase in rCMRglc: Ke=7,049: x,y,z= 66, -18, 26. Right BA 1, 3, 15, 21, 22, 23, 41, 42||||0.01
70938250|NCT00689351|141376475|SUPERIORITY_OR_OTHER|||||||0.662|||||||Fisher Exact|||Comparison between treatments for mild redness.||||0.662
71111596|NCT02969915|141729784|SUPERIORITY||Risk Ratio (RR)|1.21|||||TWO_SIDED|95.0|0.64|2.26||||||||2.26|0.64|
71111597|NCT02969915|141729785|SUPERIORITY||Risk Ratio (RR)|1.31|||||TWO_SIDED|95.0|0.91|1.9||||||||1.90|0.91|
71111598|NCT02969915|141729786|SUPERIORITY||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.7|1.95||||||||1.95|0.70|
71111599|NCT02969915|141729787|SUPERIORITY||Risk Ratio (RR)|1.29|||||TWO_SIDED|95.0|0.85|1.95||||||||1.95|0.85|
71111600|NCT02969915|141729788|SUPERIORITY||Risk Ratio (RR)|1.17|||||TWO_SIDED|95.0|0.79|1.75||||||||1.75|0.79|
71111601|NCT02969915|141729789|SUPERIORITY||Risk Ratio (RR)|1.48|||||TWO_SIDED|95.0|0.38|5.76||||||||5.76|0.38|
71111602|NCT02969915|141729790|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.68|1.36||||||||1.36|0.68|
71111603|NCT02969915|141729791|SUPERIORITY||Risk Ratio, log|1.38|||||TWO_SIDED|95.0|0.77|2.46||||||||2.46|0.77|
71111604|NCT02969915|141729792|SUPERIORITY||Risk Ratio (RR)|0.39|||||TWO_SIDED|95.0|0.09|1.8||||||||1.80|0.09|
71111605|NCT01393899|141729819|SUPERIORITY_OR_OTHER||Difference in Percentage|1.44|||||TWO_SIDED|80.0|-12.11|14.99||||||||14.99|-12.11|
70938251|NCT00689351|141376475|SUPERIORITY_OR_OTHER|||||||0.331|||||||Fisher Exact|||Comparison between treatments for moderate redness.||||0.331
70938252|NCT00689351|141376476|SUPERIORITY_OR_OTHER|||||||0.409|||||||Fisher Exact|||Comparison between treatments for any tenderness.||||0.409
70938253|NCT00689351|141376476|SUPERIORITY_OR_OTHER|||||||0.617|||||||Fisher Exact|||Comparison between treatments for significant tenderness.||||0.617
71111606|NCT01393899|141729819|SUPERIORITY_OR_OTHER||Difference in Percentage|17.72|||||TWO_SIDED|80.0|4.07|31.37||||||||31.37|4.07|
71111607|NCT01393899|141729820|SUPERIORITY_OR_OTHER||Difference in Percentage|0.61|||||TWO_SIDED|80.0|-11.57|12.79||||||Week 4||12.79|-11.57|
71111608|NCT01393899|141729820|SUPERIORITY_OR_OTHER||Difference in Percentage|0.78|||||TWO_SIDED|80.0|-12.29|13.84||||||Week 8||13.84|-12.29|
71111609|NCT01393899|141729820|SUPERIORITY_OR_OTHER||Difference in Percentage|5.81|||||TWO_SIDED|80.0|-8.04|19.67||||||Week 12||19.67|-8.04|
71111610|NCT01393899|141729820|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.94|||||TWO_SIDED|80.0|-14.56|12.68||||||Week 20||12.68|-14.56|
71111611|NCT01393899|141729820|SUPERIORITY_OR_OTHER||Difference in Percentage|5.26|||||TWO_SIDED|80.0|-6.52|17.04||||||Week 4||17.04|-6.52|
71111612|NCT01393899|141729820|SUPERIORITY_OR_OTHER||Difference in Percentage|-8.53|||||TWO_SIDED|80.0|-21.94|4.88||||||Week 8||4.88|-21.94|
71111613|NCT01393899|141729820|SUPERIORITY_OR_OTHER||Difference in Percentage|3.49|||||TWO_SIDED|80.0|-10.4|17.37||||||Week 12||17.37|-10.40|
71111614|NCT01393899|141729820|SUPERIORITY_OR_OTHER||Difference in Percentage|10.69|||||TWO_SIDED|80.0|-3.08|24.46||||||Week 20||24.46|-3.08|
71111615|NCT01393899|141729821|SUPERIORITY_OR_OTHER||Difference in Percentage|-1.72|||||TWO_SIDED|80.0|-14.06|10.63||||||Week 4||10.63|-14.06|
71111616|NCT01393899|141729821|SUPERIORITY_OR_OTHER||Difference in Percentage|-3.88|||||TWO_SIDED|80.0|-17.15|9.4||||||Week 8||9.40|-17.15|
71111617|NCT01393899|141729821|SUPERIORITY_OR_OTHER||Difference in Percentage|5.81|||||TWO_SIDED|80.0|-8.04|19.67||||||Week 12||19.67|-8.04|
71111618|NCT01393899|141729821|SUPERIORITY_OR_OTHER||Difference in Percentage|1.44|||||TWO_SIDED|80.0|-12.11|14.99||||||Week 20||14.99|-12.11|
71111619|NCT01393899|141729821|SUPERIORITY_OR_OTHER||Difference in Percentage|1.5|||||TWO_SIDED|80.0|-11.88|14.87||||||Week 26||14.87|-11.88|
71111620|NCT01393899|141729821|SUPERIORITY_OR_OTHER||Difference in Percentage|2.93|||||TWO_SIDED|80.0|-9.06|14.92||||||Week 4||14.92|-9.06|
71111621|NCT01393899|141729821|SUPERIORITY_OR_OTHER||Difference in Percentage|-8.53|||||TWO_SIDED|80.0|-21.94|4.88||||||Week 8||4.88|-21.94|
71111622|NCT01393899|141729821|SUPERIORITY_OR_OTHER||Difference in Percentage|1.16|||||TWO_SIDED|80.0|-12.74|15.06||||||Week 12||15.06|-12.74|
71111623|NCT01393899|141729821|SUPERIORITY_OR_OTHER||Difference in Percentage|13.07|||||TWO_SIDED|80.0|-0.63|26.77||||||Week 20||26.77|-0.63|
71111624|NCT01393899|141729821|SUPERIORITY_OR_OTHER||Difference in Percentage|20.1|||||TWO_SIDED|80.0|6.54|33.66||||||Week 26||33.66|6.54|
71111625|NCT01393899|141729822|SUPERIORITY_OR_OTHER||Difference in Percentage|3.43|||||TWO_SIDED|80.0|-10.41|17.28||||||Week 4||17.28|-10.41|
71111626|NCT01393899|141729822|SUPERIORITY_OR_OTHER||Difference in Percentage|1.22|||||TWO_SIDED|80.0|-12.67|15.11||||||Week 8||15.11|-12.67|
71111627|NCT01393899|141729822|SUPERIORITY_OR_OTHER||Difference in Percentage|13.18|||||TWO_SIDED|80.0|-0.31|26.67||||||Week 12||26.67|-0.31|
71111628|NCT01393899|141729822|SUPERIORITY_OR_OTHER||Difference in Percentage|1.61|||||TWO_SIDED|80.0|-11.33|14.55||||||Week 20||14.55|-11.33|
71111629|NCT01393899|141729822|SUPERIORITY_OR_OTHER||Difference in Percentage|8.64|||||TWO_SIDED|80.0|-4.36|21.64||||||Week 26||21.64|-4.36|
71111630|NCT01393899|141729822|SUPERIORITY_OR_OTHER||Difference in Percentage|5.76|||||TWO_SIDED|80.0|-8.04|19.56||||||Week 4||19.56|-8.04|
70938254|NCT00689351|141376476|SUPERIORITY_OR_OTHER|||||||0.807|||||||Fisher Exact|||Comparison between treatments for any swelling.||||0.807
71111631|NCT01393899|141729822|SUPERIORITY_OR_OTHER||Difference in Percentage|-8.08|||||TWO_SIDED|80.0|-21.83|5.66||||||Week 8||5.66|-21.83|
71111632|NCT01393899|141729822|SUPERIORITY_OR_OTHER||Difference in Percentage|1.55|||||TWO_SIDED|80.0|-11.63|14.73||||||Week 12||14.73|-11.63|
71111633|NCT01393899|141729822|SUPERIORITY_OR_OTHER||Difference in Percentage|8.58|||||TWO_SIDED|80.0|-4.64|21.81||||||Week 20||21.81|-4.64|
70938255|NCT00689351|141376476|SUPERIORITY_OR_OTHER|||||||0.527|||||||Fisher Exact|||Comparison between treatments for mild swelling.||||0.527
71065801|NCT00554515|141640906|SUPERIORITY|||||||0.89|||||||Fisher Exact|||Objective response rates were compared between clear cell histology subgroups||||.89
70938256|NCT00689351|141376476|SUPERIORITY_OR_OTHER|||||||0.144|||||||Fisher Exact|||Comparison between treatments for moderate swelling.||||0.144
70938257|NCT00689351|141376476|SUPERIORITY_OR_OTHER|||||||0.495|||||||Fisher Exact|||Comparison between treatments for severe swelling.||||0.495
70938258|NCT00689351|141376476|SUPERIORITY_OR_OTHER|||||||0.506|||||||Fisher Exact|||Comparison between treatments for any redness.||||0.506
70938259|NCT00689351|141376476|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Fisher Exact|||Comparison between treatments for mild redness.||||>0.99
70938260|NCT00689351|141376476|SUPERIORITY_OR_OTHER|||||||0.2|||||||Fisher Exact|||Comparison between treatments for moderate redness.||||0.200
70938261|NCT00689351|141376477|SUPERIORITY_OR_OTHER|||||||0.633|||||||Fisher Exact|||Comparison between treatments for fever ≥38 degrees C but but less than or equal to (≤)39 degrees C.||||0.633
70938262|NCT00689351|141376477|SUPERIORITY_OR_OTHER|||||||0.721|||||||Fisher Exact|||Comparison between treatments for decreased appetite.||||0.721
70938263|NCT00689351|141376477|SUPERIORITY_OR_OTHER|||||||0.009|||||||Fisher Exact|||Comparison between treatments for irritability.||||0.009
70938264|NCT00689351|141376477|SUPERIORITY_OR_OTHER|||||||0.253|||||||Fisher Exact|||Comparison between treatments for increased sleep.||||0.253
70938265|NCT00689351|141376477|SUPERIORITY_OR_OTHER|||||||0.143|||||||Fisher Exact|||Comparison between treatments for decreased sleep.||||0.143
71065802|NCT00554515|141640907|SUPERIORITY|||||||0.19|||||||Fisher Exact|||Objective response rates were compared between CA-9 score subgroups||||.19
71065803|NCT00554515|141640908|SUPERIORITY|||||||0.01|||||||Fisher Exact|||Objective response rates were compared between PD-L1 tumor subgroups||||0.01
71065804|NCT00554515|141640909|SUPERIORITY|||||||0.08|||||||Fisher Exact|||Objective response rates were compared between B7-H3 tumor subgroups||||.08
71065805|NCT00554515|141640910|SUPERIORITY|||||||0.28|||||||Fisher Exact|||Objective response rates were compared between CA-9 SNP subgroups||||.28
71065806|NCT02977572|141640913|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||Based upon previous results, the investigators considered that the need for an intubation could be reduced by 15% \[19% in the CPAP group (control) vs. 4% in the NIV group (study)\]. The estimated sample size was 55 participants in each group (confidence interval \[1-α\] = 90% and power \[1-β\] = 85%).||||1.000
71065807|NCT01197534|141640951|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.15|||<|0.001|TWO_SIDED|95.0|0.08|0.22||Week 24|Mantel Haenszel|Treatment difference in proportion of responders using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.22|0.08|<0.001
71065808|NCT01197534|141640952|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.08|||<|0.001|TWO_SIDED|95.0|0.04|0.12|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.12|0.04|<0.001
71065809|NCT01197534|141640953|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.13|||<|0.001|TWO_SIDED|95.0|0.07|0.18|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.18|0.07|<0.001
71065810|NCT01197534|141640953|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.1|||<|0.001|TWO_SIDED|95.0|0.05|0.15|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.15|0.05|<0.001
71065811|NCT01197534|141640954|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.07|||<|0.001|TWO_SIDED|95.0|0.03|0.1|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.10|0.03|<0.001
71065812|NCT01197534|141640954|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.03||||0.033|TWO_SIDED|95.0|0.0|0.07|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.07|0.00|0.033
71065813|NCT01197534|141640955|SUPERIORITY_OR_OTHER||||||<|0.001||||||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-values are estimated using the Van Elteren test stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||||<0.001
70938266|NCT00689351|141376478|SUPERIORITY_OR_OTHER|||||||0.781|||||||Fisher Exact|||Comparison between treatments for fever ≥38 degrees C but ≤39 degrees C.||||0.781
70938267|NCT00689351|141376478|SUPERIORITY_OR_OTHER|||||||0.06|||||||Fisher Exact|||Comparison between treatments for decreased appetite.||||0.060
70938268|NCT00689351|141376478|SUPERIORITY_OR_OTHER|||||||0.159|||||||Fisher Exact|||Comparison between treatments for irritability.||||0.159
70938269|NCT00689351|141376478|SUPERIORITY_OR_OTHER|||||||0.839|||||||Fisher Exact|||Comparison between treatments for increased sleep.||||0.839
70938270|NCT00689351|141376478|SUPERIORITY_OR_OTHER|||||||0.264|||||||Fisher Exact|||Comparison between treatments for decreased sleep.||||0.264
70938271|NCT00689351|141376479|SUPERIORITY_OR_OTHER|||||||0.563|||||||Fisher Exact|||Comparison between treatments for fever ≥38 degrees C but ≤39 degrees C.||||0.563
70938272|NCT00689351|141376479|SUPERIORITY_OR_OTHER|||||||0.468|||||||Fisher Exact|||Comparison between treatments for fever \>39 degrees C but ≤40 degrees C.||||0.468
70938273|NCT00689351|141376479|SUPERIORITY_OR_OTHER|||||||0.535|||||||Fisher Exact|||Comparison between treatments for decreased appetite.||||0.535
70938274|NCT00689351|141376479|SUPERIORITY_OR_OTHER|||||||0.019|||||||Fisher Exact|||Comparison between treatments for irritability.||||0.019
71065814|NCT01197534|141640955|SUPERIORITY_OR_OTHER||||||<|0.001||||||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-values are estimated using the Van Elteren test stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||||<0.001
71065815|NCT01197534|141640956|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.1|||<|0.001|TWO_SIDED|95.0|3.42|14.8|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||14.80|3.42|<0.001
71065816|NCT01197534|141640956|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0|||<|0.001|TWO_SIDED|95.0|1.88|8.65|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||8.65|1.88|<0.001
71065817|NCT01197534|141640957|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.3|||<|0.001|TWO_SIDED|95.0|3.23|16.65|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||16.65|3.23|<0.001
71065818|NCT01197534|141640957|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.4|||<|0.001|TWO_SIDED|95.0|2.81|14.71|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||14.71|2.81|<0.001
71065819|NCT01197534|141640958|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.84|||<|0.001|TWO_SIDED|95.0|2.06|3.91||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|Proportional odds model|No Response, moderate response and good response are included in the model, with treatment, background use of DMARD and pooled country as factors.|An odds ratio \> 1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.91|2.06|<0.001
71111634|NCT01393899|141729822|SUPERIORITY_OR_OTHER||Difference in Percentage|13.29|||||TWO_SIDED|80.0|0.15|26.43||||||Week 26||26.43|0.15|
71111635|NCT01393899|141729823|SUPERIORITY_OR_OTHER||Difference in Percentage|6.57|||||TWO_SIDED|80.0|-8.63|21.78||||||Week 4||21.78|-8.63|
71111636|NCT01393899|141729823|SUPERIORITY_OR_OTHER||Difference in Percentage|0.29|||||TWO_SIDED|80.0|-16.63|17.2||||||Week 8||17.20|-16.63|
71111637|NCT01393899|141729823|SUPERIORITY_OR_OTHER||Difference in Percentage|24.29|||||TWO_SIDED|80.0|7.19|41.38||||||Week 12||41.38|7.19|
71111638|NCT01393899|141729823|SUPERIORITY_OR_OTHER||Difference in Percentage|6.86|||||TWO_SIDED|80.0|-10.32|24.03||||||Week 20||24.03|-10.32|
70938275|NCT00689351|141376479|SUPERIORITY_OR_OTHER|||||||0.398|||||||Fisher Exact|||Comparison between treatments for increased sleep.||||0.398
70938276|NCT00689351|141376479|SUPERIORITY_OR_OTHER|||||||0.125|||||||Fisher Exact|||Comparison between treatments for decreased sleep.||||0.125
70938277|NCT00689351|141376480|SUPERIORITY_OR_OTHER|||||||0.596|||||||Fisher Exact|||Comparison between treatments for fever ≥38 degrees C but ≤39 degrees C.||||0.596
70938278|NCT00689351|141376480|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Fisher Exact|||Comparison between treatments for fever \>39 degrees C but ≤40 degrees C.||||>0.99
70938279|NCT00689351|141376480|SUPERIORITY_OR_OTHER|||||||0.663|||||||Fisher Exact|||Comparison between treatments for decreased appetite.||||0.663
70938280|NCT00689351|141376480|SUPERIORITY_OR_OTHER|||||||0.439|||||||Fisher Exact|||Comparison between treatments for irritability.||||0.439
71111639|NCT01393899|141729823|SUPERIORITY_OR_OTHER||Difference in Percentage|11.29|||||TWO_SIDED|80.0|-5.22|27.79||||||Week 26||27.79|-5.22|
71111640|NCT01393899|141729823|SUPERIORITY_OR_OTHER||Difference in Percentage|8.77|||||TWO_SIDED|80.0|-6.41|23.95||||||Week 4||23.95|-6.41|
71111641|NCT01393899|141729823|SUPERIORITY_OR_OTHER||Difference in Percentage|-14.0|||||TWO_SIDED|80.0|-31.59|3.59||||||Week 8||3.59|-31.59|
71111642|NCT01393899|141729823|SUPERIORITY_OR_OTHER||Difference in Percentage|2.31|||||TWO_SIDED|80.0|-15.35|19.97||||||Week 12||19.97|-15.35|
70938281|NCT00689351|141376480|SUPERIORITY_OR_OTHER|||||||0.613|||||||Fisher Exact|||Comparison between treatments for increased sleep.||||0.613
70938282|NCT00689351|141376480|SUPERIORITY_OR_OTHER|||||||0.138|||||||Fisher Exact|||Comparison between treatments for decreased sleep.||||0.138
70938283|NCT01313663|141376491|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|90.0|0.32|2.65|||||HRs were estimated using the Pike estimator. The hazard ratio and p-value from the stratified log-rank test were adjusted for disease stage at Baseline only, due to sparse data.|||2.65|0.32|
70938284|NCT02255474|141376506|SUPERIORITY||Mean Difference (Final Values)|-1.01|||<|0.01|TWO_SIDED|||||Adjusted for multiple comparisons, treatment group p-value|Mixed Models Analysis|||Both eyes used in analysis adjusting for correlation.||||<0.01
70938285|NCT02255474|141376507|SUPERIORITY||quadratic coefficient|0.02||||0.05|TWO_SIDED||||||Mixed Models Analysis|||Individual subject eye length profiles were fit using quadratic equations as a function of gaze angle. The analysis of quadratic coefficients included treatment group, study year (categorical variable), and their interaction adjusted for age, study site, and ethnicity.||||0.05
70938286|NCT02255474|141376508|SUPERIORITY||regression coefficient|-0.12||||0.05|TWO_SIDED||||||Regression, Linear|Models control for age, sex, axial length at baseline, race, treatment group, treatment group by race interaction.||This analysis looks at the three-year change in spherical equivalent refractive error for different eccentricities of peripheral defocus measured with contact lenses in place||||0.05
70938287|NCT02255474|141376509|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.05|TWO_SIDED|||||Adjusted for multiple comparisons|Mixed Models Analysis|||Both eyes used in the analysis controlling for the correlation.||||0.05
71065820|NCT01197534|141640958|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.44|||<|0.001|TWO_SIDED|95.0|1.77|3.37||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|Proportional odds model|No Response, moderate response and good response are included in the model, with treatment, background use of DMARD and pooled country as factors.|An odds ratio \> 1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.37|1.77|<0.001
71111643|NCT01393899|141729823|SUPERIORITY_OR_OTHER||Difference in Percentage|10.15|||||TWO_SIDED|80.0|-7.41|27.71||||||Week 20||27.71|-7.41|
70938288|NCT01082159|141376541|SUPERIORITY_OR_OTHER||change from baseline|3.59|STANDARD_DEVIATION|2.87|<|0.0001|TWO_SIDED|95.0|2.76|4.42|||t-test, 2 sided|||||4.42|2.76|<0.0001
70938289|NCT01082159|141376542|SUPERIORITY_OR_OTHER||Change from Baseline|12.17|STANDARD_DEVIATION|19.14|<|0.0001|TWO_SIDED|95.0|6.64|17.71|||t-test, 2 sided|||||17.71|6.64|<0.0001
70938290|NCT02367794|141376557|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0006|TWO_SIDED|95.0|0.64|0.88|||Log Rank|||||0.88|0.64|0.0006
70938291|NCT02367794|141376558|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1581|TWO_SIDED|95.0|0.73|1.05|||Log Rank|||||1.05|0.73|0.1581
71111644|NCT01393899|141729823|SUPERIORITY_OR_OTHER||Difference in Percentage|22.0|||||TWO_SIDED|80.0|4.96|39.04||||||Week 26||39.04|4.96|
70938292|NCT02367794|141376559|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.876||||0.4451|TWO_SIDED|95.0|0.623|1.231|||Log Rank|||Teff \>=-1.91 in ITT||1.231|0.623|0.4451
70938293|NCT02367794|141376559|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.941||||0.7343|TWO_SIDED|95.0|0.664|1.335|||Log Rank|||Teff \>=-1.91 in ITT||1.335|0.664|0.7343
70938294|NCT02367794|141376559|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.942||||0.661|TWO_SIDED|95.0|0.72|1.232|||Log Rank|||Teff \<-1.91 Negative in ITT||1.232|0.720|0.6610
70938295|NCT02367794|141376559|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.253||||0.0893|TWO_SIDED|95.0|0.965|1.627|||Log Rank|||Teff \<-1.91 Negative in ITT||1.627|0.965|0.0893
70938296|NCT02367794|141376560|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.61||||0.0006|TWO_SIDED|95.0|0.46|0.81|||Log Rank|||Teff\>=-1.91||0.81|0.46|0.0006
70938297|NCT02367794|141376560|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.06||||0.63|TWO_SIDED|95.0|0.84|1.33|||Log Rank|||Teff\>=-1.91||1.33|0.84|0.630
70938298|NCT02367794|141376560|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.88||||0.258|TWO_SIDED|95.0|0.7|1.1|||Log Rank|||Teff\<-1.91||1.10|0.70|0.258
70938299|NCT02367794|141376560|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.06||||0.63|TWO_SIDED|95.0|0.84|1.33|||Log Rank|||Teff\<-1.91||1.33|0.84|0.630
70938300|NCT02367794|141376561|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.4|0.72|||Log Rank|||||0.72|0.40|<.0001
70938301|NCT02367794|141376561|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.61||||0.0018|TWO_SIDED|95.0|0.45|0.84|||Log Rank|||||0.84|0.45|0.0018
70938302|NCT02367794|141376562|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.48|0.77|||Log Rank|||||0.77|0.48|<.0001
70938303|NCT02367794|141376562|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.48|0.77|||Log Rank|||||0.77|0.48|<.0001
70938304|NCT02367794|141376563|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.725||||0.0518|TWO_SIDED|95.0|0.524|1.004|||Log Rank|||||1.004|0.524|0.0518
70938305|NCT02367794|141376563|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.832||||0.2841|TWO_SIDED|95.0|0.594|1.165|||Log Rank|||||1.165|0.594|0.2841
71111645|NCT01393899|141729824|SUPERIORITY_OR_OTHER||Difference in Percentage|1.83|||||TWO_SIDED|80.0|-9.75|13.4||||||||13.40|-9.75|
70938306|NCT02367794|141376564|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.871||||0.2956|TWO_SIDED|95.0|0.671|1.129|||Log Rank|||||1.129|0.671|0.2956
70938307|NCT02367794|141376564|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.861||||0.2473|TWO_SIDED|95.0|0.668|1.109|||Log Rank|||||1.109|0.668|0.2473
70938308|NCT02367794|141376565|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.41||||0.0248|TWO_SIDED|95.0|1.04|1.91|||Cochran-Mantel-Haenszel|||||1.91|1.04|0.0248
70938309|NCT02367794|141376565|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.4||||0.0308|TWO_SIDED|95.0|1.03|1.9|||Cochran-Mantel-Haenszel|||||1.90|1.03|0.0308
71111646|NCT01393899|141729824|SUPERIORITY_OR_OTHER||Difference in Percentage|18.11|||||TWO_SIDED|80.0|5.57|30.64||||||||30.64|5.57|
71111647|NCT01393899|141729825|SUPERIORITY_OR_OTHER||Difference in Percentage|-7.75|||||TWO_SIDED|80.0|-20.39|4.88||||||||4.88|-20.39|
71111648|NCT01393899|141729825|SUPERIORITY_OR_OTHER||Difference in Percentage|17.83|||||TWO_SIDED|80.0|4.33|31.33||||||||31.33|4.33|
71111649|NCT01393899|141729827|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-30.26|||=|0.0637|TWO_SIDED|80.0|-51.1|-9.42|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 4||-9.42|-51.10|=0.0637
70938310|NCT02367794|141376566|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.408|0.689|||Log Rank|||||0.689|0.408|<.0001
70938311|NCT02367794|141376566|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.64||||0.0007|TWO_SIDED|95.0|0.493|0.831|||Log Rank|||||0.831|0.493|0.0007
70938312|NCT02367794|141376567|SUPERIORITY||Difference in Event Free Rate|0.06||||0.9871|TWO_SIDED|95.0|-7.48|7.61|||Z-test|||Event Free Rate (%) at Year 1||7.61|-7.48|0.9871
70938313|NCT02367794|141376567|SUPERIORITY||Difference in Event Free Rate|5.93||||0.1133|TWO_SIDED|95.0|-1.41|13.26|||Z-test|||Event Free Rate (%) at Year 2||13.26|-1.41|0.1133
70938314|NCT02367794|141376567|SUPERIORITY||Difference in Event Free Rate|-3.97||||0.3072|TWO_SIDED|95.0|-11.6|3.65|||Z-test|||Event Free Rate (%) at Year 1||3.65|-11.60|0.3072
71065821|NCT01197534|141640959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|||<|0.001|TWO_SIDED|95.0|1.73|3.46|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.46|1.73|<0.001
71065822|NCT01197534|141640959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||<|0.001|TWO_SIDED|95.0|1.46|2.94|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.94|1.46|<0.001
71065823|NCT01197534|141640960|SUPERIORITY_OR_OTHER|||||||0.904||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Cochran-Mantel-Haenszel|Residuals from ANCOVA are analysed using a Cochran-Mantel-Haenszel approach, adjusting for the effects of pooled country and background use of DMARD.||This analysis is performed using an ANCOVA model on the ranks of the change from baseline, by pooled country and background use of DMARD, including a term for the ranks of the baseline score as a covariate.||||0.904
71065824|NCT01197534|141640960|SUPERIORITY_OR_OTHER|||||||0.342||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Cochran-Mantel-Haenszel|Residuals from ANCOVA are analysed using a Cochran-Mantel-Haenszel approach, adjusting for the effects of pooled country and background use of DMARD.||This analysis is performed using an ANCOVA model on the ranks of the change from baseline, by pooled country and background use of DMARD, including a term for the ranks of the baseline score as a covariate.||||0.342
71065825|NCT01197534|141640961|SUPERIORITY_OR_OTHER||Treatment difference|2.47|||<|0.001|TWO_SIDED|95.0|1.47|3.48||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as continuous covariate and treatment, background use of DMARD and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.48|1.47|<0.001
70852697|NCT01578850|141194334|SUPERIORITY_OR_OTHER||Difference in proportions|24.1|||<|0.001|TWO_SIDED|95.0|13.88|34.4|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: LDA: Week 36||34.40|13.88|<0.001
70938315|NCT02367794|141376567|SUPERIORITY||Difference in Event Free Rate|1.21||||0.743|TWO_SIDED|95.0|-6.01|8.42|||Z-test|||Event Free Rate (%) at Year 2||8.42|-6.01|0.7430
70938316|NCT02367794|141376568|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.797||||0.0461|TWO_SIDED|95.0|0.638|0.996|||Log Rank|||||0.996|0.638|0.0461
70938317|NCT02367794|141376568|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.04||||0.7295|TWO_SIDED|95.0|0.834|1.296|||Log Rank|||||1.296|0.834|0.7295
70938318|NCT02367794|141376569|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.828||||0.0942|TWO_SIDED|95.0|0.663|1.033|||Log Rank|||||1.033|0.663|0.0942
70938319|NCT02367794|141376569|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.968||||0.7709|TWO_SIDED|95.0|0.776|1.207|||Log Rank|||||1.207|0.776|0.7709
70938320|NCT02367794|141376571|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.93||||0.4007|TWO_SIDED|95.0|0.784|1.102|||Log Rank|||||1.102|0.784|0.4007
71065826|NCT01197534|141640961|SUPERIORITY_OR_OTHER||Treatment difference|1.64||||0.001|TWO_SIDED|95.0|0.63|2.65||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as continuous covariate and treatment, background use of DMARD and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.65|0.63|0.001
71065827|NCT01197534|141640962|SUPERIORITY_OR_OTHER||Treatment difference|2.09|||<|0.001|TWO_SIDED|95.0|0.97|3.2||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as continuous covariate and treatment, background use of DMARD and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.20|0.97|<0.001
70852698|NCT01578850|141194334|SUPERIORITY_OR_OTHER||Difference in proportions|27.1|||<|0.001|TWO_SIDED|95.0|16.85|37.35|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: LDA: Week 44||37.35|16.85|<0.001
70938321|NCT00882050|141376580|OTHER|||||||0.05|||||||Regression, Logistic|||logistic regression|Because we tested interventions against the placebo arm, we increased our subjects to overcome loss of power. 23 per group will provide 80% power assuming a reduced alpha of 0.01 to accommodate the multiple testing issues.|||0.05
70941772|NCT04748445|141383935|OTHER||Slope|-0.0000415|STANDARD_ERROR_OF_MEAN|1.134||0.715|TWO_SIDED|90.0|-0.0002294|0.0001464|||Mixed Models Analysis|||READ\_MFCC 1st order delta 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0001464|-0.0002294|0.7150
70938322|NCT00882050|141376580|SUPERIORITY|Demographic data analyzed with nominal data tested by chi-square, ordinal data by Mann-Whitney, and normal data by t-test. Further, a linear regression analysis to determine the effect of intervention dose on glucose level and typical confounders such as age, weight, and type of surgery was completed. Adverse and SAEs were analyzed by chi-square for occurrence.||||||0.05||||||Due to have 3 trial groups our p value was adjusted for multiple comparisons as a a priori threshold (if a single comparison) was 0.05.|Regression, Logistic|The regression (see above) is a secondary analysis. Groups had been stratified on diabetic (y/n) to balance this potential confounder||Primary t tests of glucose between the 3 groups at 90 minutes post. Secondary MANOVA to determine the effect over time. Change in mean glucose of 20 mg/dl between all groups detectable by 18 subjects per group assuming a SD of 20mg/dl., an 82% power with an alpha of 0.05. Because we tested interventions against the placebo arm, we increased our subjects to overcome loss of power. 23 per group will provide 80% power assuming a reduced alpha of 0.01 to accommodate the multiple testing issues.||||0.05
70938323|NCT00091572|141376612|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.2663||95.0|0.8|1.06|||Log Rank||Temozolomide events (progressions/deaths) = 401. Dacarbazine events (progressions/deaths) = 398.|||1.06|0.80|0.2663
71065828|NCT01197534|141640962|SUPERIORITY_OR_OTHER||Treatment difference|1.96|||<|0.001|TWO_SIDED|95.0|0.83|3.08||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as continuous covariate and treatment, background use of DMARD and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.08|0.83|<0.001
71065829|NCT02811965|141641021|SUPERIORITY||||||<|5e-05||||||A priori threshold p \< 0.05|Repeated Measures ANOVA|||||||<0.00005
71111650|NCT01393899|141729827|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-21.06|||=|0.3054|TWO_SIDED|80.0|-47.43|5.31|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8||5.31|-47.43|=0.3054
71111651|NCT01393899|141729827|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-42.52|||=|0.1316|TWO_SIDED|80.0|-78.57|-6.48|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12||-6.48|-78.57|=0.1316
71111652|NCT01393899|141729827|SUPERIORITY_OR_OTHER||Adjusted Mean Dofference|-18.01|||=|0.5704|TWO_SIDED|80.0|-59.01|22.99|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 20||22.99|-59.01|=0.5704
71111653|NCT01393899|141729827|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.0|||=|0.8389|TWO_SIDED|80.0|-44.22|32.21|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26||32.21|-44.22|=0.8389
71065830|NCT02811965|141641021|SUPERIORITY|||||||5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.00005
71111654|NCT01393899|141729827|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-23.56|||=|0.1452|TWO_SIDED|80.0|-44.27|-2.85|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 4||-2.85|-44.27|=0.1452
71065831|NCT02811965|141641021|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71111655|NCT01393899|141729827|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-9.61|||=|0.6399|TWO_SIDED|80.0|-36.03|16.81|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8||16.81|-36.03|=0.6399
71111656|NCT01393899|141729827|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-37.0|||=|0.1949|TWO_SIDED|80.0|-73.57|-0.42|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12||-0.42|-73.57|=0.1949
71111657|NCT01393899|141729827|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-47.74|||=|0.1358|TWO_SIDED|80.0|-88.62|-6.87|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 20||-6.87|-88.62|=0.1358
71111658|NCT01393899|141729827|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-50.38|||=|0.089|TWO_SIDED|80.0|-88.03|-12.72|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26||-12.72|-88.03|=0.0890
71065832|NCT02811965|141641021|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71065833|NCT02811965|141641021|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71111659|NCT01393899|141729828|SUPERIORITY_OR_OTHER||Difference in Percentage|-7.44|||||TWO_SIDED|80.0|-16.14|1.26||||||Week 4||1.26|-16.14|
71111660|NCT01393899|141729828|SUPERIORITY_OR_OTHER||Difference in Percentage|-7.43|||||TWO_SIDED|80.0|-18.27|3.41||||||Week 8||3.41|-18.27|
71111661|NCT01393899|141729828|SUPERIORITY_OR_OTHER||Difference in Percentage|-12.48|||||TWO_SIDED|80.0|-25.68|0.72||||||Week 12||0.72|-25.68|
71111662|NCT01393899|141729828|SUPERIORITY_OR_OTHER||Difference in Percentage|-12.73|||||TWO_SIDED|80.0|-26.81|1.34||||||Week 20||1.34|-26.81|
71111663|NCT01393899|141729828|SUPERIORITY_OR_OTHER||Difference in Percentage|-18.9|||||TWO_SIDED|80.0|-39.52|1.72||||||Week 26||1.72|-39.52|
71111664|NCT01393899|141729828|SUPERIORITY_OR_OTHER||Difference in Percentage|-2.96|||||TWO_SIDED|80.0|-12.39|6.48||||||Week 4||6.48|-12.39|
71111665|NCT01393899|141729828|SUPERIORITY_OR_OTHER||Difference in Percentage|1.61|||||TWO_SIDED|80.0|-10.14|13.36||||||Week 8||13.36|-10.14|
71111666|NCT01393899|141729828|SUPERIORITY_OR_OTHER||Difference in Percentage|-8.09|||||TWO_SIDED|80.0|-21.54|5.36||||||Week 12||5.36|-21.54|
71111667|NCT01393899|141729828|SUPERIORITY_OR_OTHER||Difference in Percentage|-12.9|||||TWO_SIDED|80.0|-26.99|1.19||||||Week 20||1.19|-26.99|
70938324|NCT00091572|141376613|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9999||95.0|0.86|1.17|||Log Rank||Temozolomide events (deaths) = 320. Dacarbazine events (deaths) = 325.|||1.17|0.86|0.9999
71065834|NCT02811965|141641021|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71065835|NCT02811965|141641021|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71065836|NCT02811965|141641021|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71065837|NCT02811965|141641021|SUPERIORITY|||||||0.01||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.01
71065838|NCT02811965|141641021|SUPERIORITY|||||||0.0002||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.0002
71065839|NCT02811965|141641021|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71065840|NCT02811965|141641021|SUPERIORITY||||||<|5e-05|||||||t-test, 2 sided|||||||<0.00005
71065841|NCT02811965|141641021|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71065842|NCT02811965|141641021|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71065843|NCT02811965|141641021|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71065844|NCT02811965|141641021|SUPERIORITY|||||||0.24||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.24
71065845|NCT02811965|141641021|SUPERIORITY|||||||0.14||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.14
71065846|NCT02811965|141641021|SUPERIORITY|||||||0.0093||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.0093
71065847|NCT02811965|141641021|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71065848|NCT02811965|141641021|SUPERIORITY|||||||0.14||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.14
71065849|NCT02811965|141641021|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71065850|NCT02811965|141641021|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71065851|NCT02811965|141641022|SUPERIORITY||||||<|5e-05||||||A priori threshold p\<0.05.|Repeated Measures ANOVA|||||||<0.00005
71065852|NCT02811965|141641022|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71065853|NCT02811965|141641022|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71065854|NCT02811965|141641022|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71065855|NCT02811965|141641022|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71065856|NCT02811965|141641022|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71065857|NCT02811965|141641022|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71065858|NCT02811965|141641022|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71065859|NCT02811965|141641022|SUPERIORITY|||||||0.0011||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.0011
71065860|NCT02811965|141641022|SUPERIORITY|||||||5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.00005
71065861|NCT02811965|141641022|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71065862|NCT02811965|141641022|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71065863|NCT02811965|141641022|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71065864|NCT02811965|141641022|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71065865|NCT02811965|141641022|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71065866|NCT02811965|141641022|SUPERIORITY|||||||0.53||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.53
71065867|NCT02811965|141641022|SUPERIORITY|||||||0.092||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.092
71065868|NCT02811965|141641022|SUPERIORITY|||||||0.0044|||||||t-test, 2 sided|||||||0.0044
71065869|NCT02811965|141641022|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71065870|NCT02811965|141641022|SUPERIORITY|||||||0.084||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.084
71065871|NCT02811965|141641022|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71065872|NCT02811965|141641022|SUPERIORITY|||||||5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.00005
71065873|NCT00615550|141641032|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.55||||0.02|TWO_SIDED|95.0|0.33|0.92|||Cochran-Mantel-Haenszel|||||0.92|0.33|0.020
71065874|NCT00615550|141641033|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||Cochran-Mantel-Haenszel|||Statistical analysis presented for composite score data.||||0.048
71065875|NCT00615550|141641033|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.39||||0.026|TWO_SIDED|95.0|0.17|0.92|||Cochran-Mantel-Haenszel|||Statistical analysis presented for RDS data.||0.92|0.17|0.026
71065876|NCT00615550|141641034|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5||||0.036|TWO_SIDED|95.0|0.25|0.97|||Cochran-Mantel-Haenszel|||Statistical analysis presented for births \<=27 6/7 weeks data.||0.97|0.25|0.036
71065877|NCT00615550|141641034|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.62||||0.016|TWO_SIDED|95.0|0.42|0.92|||Cochran-Mantel-Haenszel|||Statistical analysis presented for \<= 34 6/7 weeks data.||0.92|0.42|0.016
71065878|NCT00615550|141641034|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.89||||0.376|TWO_SIDED|95.0|0.68|1.16|||Cochran-Mantel-Haenszel|||Statistical analysis presented for \<36 weeks data.||1.16|0.68|0.376
71065879|NCT00615550|141641035|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.57||||0.431|TWO_SIDED|95.0|0.14|2.35|||Cochran-Mantel-Haenszel|||||2.35|0.14|0.431
71065880|NCT00615550|141641036|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.47||||0.01|TWO_SIDED|95.0|0.26|0.85|||Cochran-Mantel-Haenszel|||Statistical analysis for birth weight \< 1500 grams data.||0.85|0.26|0.01
70852699|NCT01578850|141194334|SUPERIORITY_OR_OTHER||Difference in proportions|24.0|||<|0.001|TWO_SIDED|95.0|13.61|34.42|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: LDA: Week 52||34.42|13.61|<0.001
71065881|NCT00615550|141641036|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.83||||0.213|TWO_SIDED|95.0|0.62|1.11|||Cochran-Mantel-Haenszel|||Statistical analysis for birth weight \< 2500 grams data.||1.11|0.62|0.213
71065882|NCT02640664|141641052|SUPERIORITY||Mean Difference (Net)|4.7|STANDARD_ERROR_OF_MEAN|2.93|||TWO_SIDED|95.0|-1.1|10.5||primary endpoint in the extension study does not have p-values. It's a descriptive analysis.|ANOVA|||||10.5|-1.1|
71065883|NCT02640664|141641052|SUPERIORITY||Mean Difference (Net)|2.5|STANDARD_ERROR_OF_MEAN|2.96|||TWO_SIDED|95.0|-3.4|8.3||primary endpoint in the extension study does not have p-values. It's a descriptive analysis.|ANOVA|||||8.3|-3.4|
71065884|NCT02640664|141641052|SUPERIORITY||Mean Difference (Net)|2.2|STANDARD_ERROR_OF_MEAN|2.79|||TWO_SIDED|95.0|-3.3|7.8||primary endpoint in the extension study does not have p-values. It's a descriptive analysis.|ANOVA|||||7.8|-3.3|
70852700|NCT01578850|141194334|SUPERIORITY_OR_OTHER||Difference in proportions|2.3||||0.774|TWO_SIDED|95.0|-5.5|10.06|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Remission: Week 24||10.06|-5.50|0.774
71065885|NCT02640664|141641055|SUPERIORITY||Mean Difference (Net)|8.0|STANDARD_ERROR_OF_MEAN|4.42|||TWO_SIDED|95.0|-0.8|16.7||P value not applicable because it's a descriptive analysis.|ANOVA|||||16.7|-0.8|
71065886|NCT02640664|141641055|SUPERIORITY||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|4.49|||TWO_SIDED|95.0|-7.3|10.5||P value not applicable because it's a descriptive analysis.|ANOVA|||||10.5|-7.3|
71065887|NCT02640664|141641055|SUPERIORITY||Mean Difference (Net)|6.4|STANDARD_ERROR_OF_MEAN|4.24|||TWO_SIDED|95.0|-2.0|14.8|||ANOVA|||||14.8|-2.0|
71065888|NCT01294241|141641094|SUPERIORITY_OR_OTHER||||||=|0.008||||||Post-hoc superiority analysis: Wounds that were either evaluated controversially (n=2) or as being equal (n=2) were excluded from the analysis of the primary efficacy variable.|Two-sided exact binomial test|||The intra-individual difference in reepithelialization of wound (halves) was tested using a two-sided exact binomial test. The test was performed at a significance level of 5% for the null-hypothesis of no difference δ = 0 against the hypotheses δ ≠ 0: H0: δ = 0 H1: δ ≠ 0||||=0.008
71065889|NCT01294241|141641095|SUPERIORITY_OR_OTHER||||||=|0.21||||||Post-hoc superiority analysis|Wilcoxon (Mann-Whitney)|||The intra-individual difference in median percentage of wound epithelialization was tested using a two-sided Wilcoxon test.||||=0.21
71065890|NCT01294241|141641096|SUPERIORITY_OR_OTHER|||||||0.33||||||Post-hoc superiority analysis|Wilcoxon (Mann-Whitney)|||The intra-individual difference in median percentage of wound epithelialization was tested using a two-sided Wilcoxon test.||||0.33
71065891|NCT02748213|141641098|SUPERIORITY_OR_OTHER||Difference in Response Rates|2.2||||0.717|TWO_SIDED|95.0|-10.17|14.56|||Chi-squared||The approximate 95% CI for the difference in response (CR or PR) rates was determined using the Hauck-Anderson correction.|||14.56|-10.17|0.717
71065892|NCT02748213|141641100|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0449|TWO_SIDED|95.0|0.53|0.99|||Log Rank||Hazard Ratio (HR) calculated using Herceptin + Taxotere arm as reference.|||0.99|0.53|0.0449
71065893|NCT02748213|141641102|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.4758|TWO_SIDED|95.0|0.56|1.32|||Log Rank||HR calculated using Herceptin + Taxotere arm as reference.|||1.32|0.56|0.4758
71065894|NCT02640950|141641164|SUPERIORITY||||||<|0.001||||||Paired t test for pre and post treatment scores for all subjects|t-test, 2 sided|||Paired t-test of pre and post treatment scores on MADRS||||<0.001
71065895|NCT02640950|141641165|OTHER|Descriptive Frequencies Analysis|||||||||||||||||A frequencies analysis was conducted to determine the number of participants that were diagnosed with BP I and BP II as well as the number of participants that developed an onset of maniac symptoms during the 7 week treatment period.|||
71065896|NCT00915018|141641170|SUPERIORITY||Hazard Ratio (HR)|1.015||||0.8934|TWO_SIDED|95.0|0.813|1.269|||Log Rank|||||1.269|0.813|0.8934
71065897|NCT00915018|141641171|OTHER||Risk Difference (RD)|0.028||||0.5219|TWO_SIDED|95.0|-0.048|0.105|||Mantel Haenszel|||||0.105|-0.048|0.5219
71065898|NCT00915018|141641172|OTHER||Hazard Ratio (HR)|0.974||||0.8431|TWO_SIDED|95.0|0.752|1.262|||Log Rank|||||1.262|0.752|0.8431
71065899|NCT00915018|141641173|OTHER||Risk Difference (RD)|-0.032||||0.236|TWO_SIDED|95.0|-0.093|0.029|||Mantel Haenszel|||||0.029|-0.093|0.2360
71065900|NCT00915018|141641174|OTHER||Hazard Ratio (HR)|0.449||||0.0036|TWO_SIDED|95.0|0.259|0.78|||Log Rank|||||0.780|0.259|0.0036
71065901|NCT02498444|141641207|OTHER||Risk Ratio (RR)|1.29||||0.03|TWO_SIDED|95.0|1.02|1.64|||Poisson regression|Poisson regression model demonstrating associations between treatment groups and outcomes (chest tube duration in days and length of stay in days)||||1.64|1.02|0.03
71111668|NCT01393899|141729828|SUPERIORITY_OR_OTHER||Difference in Percentage|-26.28|||||TWO_SIDED|80.0|-46.54|-6.02||||||Week 26||-6.02|-46.54|
70938325|NCT00091572|141376614|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43||||0.0718||95.0|0.97|2.12|||Cochran-Mantel-Haenszel||Temozolomide numerator (responders) = 55. Dacarbazine numerator (responders) = 37.|||2.12|0.97|0.0718
70938326|NCT02340806|141376633|SUPERIORITY|||||||0.67|||||||Chi-squared, Corrected|||||||.67
70938327|NCT02340806|141376634|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||.08
70938328|NCT02340806|141376635|SUPERIORITY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||||||.21
70938329|NCT02340806|141376636|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||.14
70938330|NCT02340806|141376637|SUPERIORITY|||||||0.66|||||||Kruskal-Wallis|||||||.66
70938331|NCT02340806|141376639|SUPERIORITY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||.92
71111669|NCT01393899|141729829|SUPERIORITY_OR_OTHER||Difference in Percentage|10.61|||||TWO_SIDED|80.0|-11.44|32.66||||||||32.66|-11.44|
70938332|NCT02340806|141376640|SUPERIORITY|||||||0.58|||||||Kruskal-Wallis|||||||.58
71065902|NCT02498444|141641208|OTHER||Risk Ratio (RR)|1.23||||0.0498|TWO_SIDED|95.0|1.0|1.51||Poisson regression model demonstrating associations between treatment groups and outcomes (chest tube duration in days and length of stay in days)|Poisson regression|||||1.51|1.00|0.0498
71065903|NCT02498444|141641209|OTHER|||||||0.05|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 0||||0.05
71111670|NCT01393899|141729829|SUPERIORITY_OR_OTHER||Difference in Percentage|16.67|||||TWO_SIDED|80.0|-4.15|37.49||||||||37.49|-4.15|
70852701|NCT01578850|141194334|SUPERIORITY_OR_OTHER||Difference in proportions|0.4||||0.645|TWO_SIDED|95.0|-7.15|8.03|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Remission: Week 28||8.03|-7.15|0.645
70938333|NCT02340806|141376641|SUPERIORITY|||||||0.67|||||||Chi-squared|||||||.67
70938334|NCT02340806|141376642|SUPERIORITY|||||||0.99|||||||Chi-squared|||||||.99
70938335|NCT02340806|141376643|SUPERIORITY|||||||0.37|||||||Kruskal-Wallis|||||||.37
70938336|NCT02591056|141376653|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||t-test, 2 sided|t=+7.45; df=26||||||<0.0001
71065904|NCT02498444|141641209|OTHER||||||<|0.01|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 12||||<0.01
70938337|NCT01159600|141376654|SUPERIORITY_OR_OTHER||Mean difference|-1.63|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|97.5|-2.17|-1.08||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|ANCOVA with baseline HbA1c and baseline body weight as linear covariates and baseline eGFR, geographical region and treatment as fixed effects|Difference calculated as Met: empa 10mg minus Met: placebo|Null hypothesis: No difference in change from baseline to week 24 in body weight between Empagliflozin 10mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons (10mg vs placebo and 25mg vs placebo) within each background therapy group (metformin and metformin + SU). If for a specific dose the null hypothesis was rejected for the primary endpoint, the same dose was tested against placebo for the change from baseline in body weight.||-1.08|-2.17|<0.0001
70938338|NCT01159600|141376654|SUPERIORITY_OR_OTHER||Mean difference|-2.01|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|97.5|-2.56|-1.46||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|ANCOVA with baseline HbA1c and baseline body weight as linear covariates and baseline eGFR, geographical region and treatment as fixed effects|Difference calculated as Met: empa 25mg minus Met: placebo|Null hypothesis: No difference in change from baseline to week 24 in body weight between Empagliflozin 25mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons (10mg vs placebo and 25mg vs placebo) within each background therapy group (metformin and metformin + SU). If for a specific dose the null hypothesis was rejected for the primary endpoint, the same dose was tested against placebo for the change from baseline in body weight.||-1.46|-2.56|<0.0001
70938339|NCT01159600|141376654|SUPERIORITY_OR_OTHER||Mean difference|-1.76|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|97.5|-2.25|-1.28||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|ANCOVA with baseline HbA1c and baseline body weight as linear covariates and baseline eGFR, geographical region and treatment as fixed effects|Difference calculated as Met+SU: empa 10mg minus Met+SU: placebo|Null hypothesis: No difference in change from baseline to week 24 in body weight between Empagliflozin 10mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons (10mg vs placebo and 25mg vs placebo) within each background therapy group (metformin and metformin + SU). If for a specific dose the null hypothesis was rejected for the primary endpoint, the same dose was tested against placebo for the change from baseline in body weight.||-1.28|-2.25|<0.0001
70941773|NCT04748445|141383935|OTHER||Slope|1.593|STANDARD_ERROR_OF_MEAN|1.291||0.2194|TWO_SIDED|90.0|-5.457|3.731|||Mixed Models Analysis|||READ\_MFCC 1st order delta 10 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-4. For lower limit it was 10\^-5).||3.731|-5.457|0.2194
70941774|NCT04748445|141383935|OTHER||Slope|0.0001893|STANDARD_ERROR_OF_MEAN|9.442||0.0471|TWO_SIDED|90.0|0.00003283|0.0003458|||Mixed Models Analysis|||READ\_MFCC 1st order delta 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-5).||0.0003458|0.00003283|0.0471
71065905|NCT02498444|141641209|OTHER|||||||0.14|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 24||||0.14
71065906|NCT02498444|141641210|OTHER|||||||0.23|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 0||||0.23
71065907|NCT02498444|141641210|OTHER|||||||0.27|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 12||||0.27
71065908|NCT02498444|141641210|OTHER|||||||0.65|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 24||||0.65
71065909|NCT02498444|141641211|OTHER|||||||0.37|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 0||||0.37
71065910|NCT02498444|141641211|OTHER||||||<|0.01|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 12||||<0.01
71111671|NCT01393899|141729831|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.93|||<|0.0001|TWO_SIDED|95.0|-1.34|-0.53|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 4||-0.53|-1.34|<0.0001
71111672|NCT01393899|141729831|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.76|||=|0.0024|TWO_SIDED|95.0|-1.24|-0.28|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8||-0.28|-1.24|=0.0024
71111673|NCT01393899|141729831|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.75|||=|0.0044|TWO_SIDED|95.0|-1.26|-0.24|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12||-0.24|-1.26|=0.0044
71111674|NCT01393899|141729831|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.56|||=|0.0582|TWO_SIDED|95.0|-1.13|0.02|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 20||0.02|-1.13|=0.0582
71111675|NCT01393899|141729831|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.61|||=|0.0865|TWO_SIDED|95.0|-1.31|0.09|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26||0.09|-1.31|=0.0865
71111676|NCT01393899|141729831|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.32|-0.52|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 4||-0.52|-1.32|<0.0001
71111677|NCT01393899|141729831|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.92|||=|0.0002|TWO_SIDED|95.0|-1.4|-0.45|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8||-0.45|-1.40|=0.0002
71111678|NCT01393899|141729831|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.23|||<|0.0001|TWO_SIDED|95.0|-1.75|-0.71|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12||-0.71|-1.75|<0.0001
71111679|NCT01393899|141729831|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.87|-0.74|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 20||-0.74|-1.87|<0.0001
71111680|NCT01393899|141729831|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.62|||<|0.0001|TWO_SIDED|95.0|-2.3|-0.95|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26||-0.95|-2.30|<0.0001
71111681|NCT01393899|141729833|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.39|||=|0.0566|TWO_SIDED|95.0|-0.79|0.01|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8||0.01|-0.79|=0.0566
71111682|NCT01393899|141729833|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21|||=|0.3144|TWO_SIDED|95.0|-0.61|0.2|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12||0.20|-0.61|=0.3144
71111683|NCT01393899|141729833|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.56|||=|0.0434|TWO_SIDED|95.0|-1.1|-0.02|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26||-0.02|-1.10|=0.0434
71111684|NCT01393899|141729833|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.57|||=|0.005|TWO_SIDED|95.0|-0.96|-0.18|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8||-0.18|-0.96|=0.0050
71111685|NCT01393899|141729833|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.66|||=|0.0017|TWO_SIDED|95.0|-1.06|-0.25|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12||-0.25|-1.06|=0.0017
71111686|NCT01393899|141729833|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.72|-0.67|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26||-0.67|-1.72|<0.0001
71111687|NCT02520388|141729855|SUPERIORITY|||||||0.05|||||||Mixed model repeated measures analysis|||||||0.05
71111688|NCT02520388|141729856|SUPERIORITY|||||||0.05|||||||Mixed model repeated measures analysis|||||||0.05
71111689|NCT03035864|141729870|SUPERIORITY||difference in LS means|-0.11|||=|0.974|TWO_SIDED|95.0|-6.85|6.63|||ANCOVA|||Frequency statistical analysis||6.63|-6.85|=0.974
70852702|NCT01578850|141194334|SUPERIORITY_OR_OTHER||Difference in proportions|8.4||||0.08|TWO_SIDED|95.0|0.36|16.35|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Remission: Week 36||16.35|0.36|0.080
70852703|NCT01578850|141194334|SUPERIORITY_OR_OTHER||Difference in proportions|9.6||||0.025|TWO_SIDED|95.0|1.49|17.68|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Remission: Week 44||17.68|1.49|0.025
71111690|NCT03035864|141729870|SUPERIORITY||Difference in least square means|2.88|||=|0.399|TWO_SIDED|95.0|-3.85|9.61|||ANCOVA|||Statistical analysis related to severity||9.61|-3.85|=0.399
71111691|NCT03035864|141729871|SUPERIORITY||difference in least square means|0.04|||=|0.214|TWO_SIDED|95.0|-0.02|0.1|||ANCOVA|||||0.10|-0.02|=0.214
71111692|NCT03035864|141729875|SUPERIORITY||difference in least square means|-0.43|||=|0.881|TWO_SIDED|95.0|-6.13|5.27|||ANCOVA|||Frequency - week 4||5.27|-6.13|=0.881
71111693|NCT03035864|141729875|SUPERIORITY||difference in least square means|-0.31|||=|0.926|TWO_SIDED|95.0|-6.96|6.33|||ANCOVA|||Frequency - week 8||6.33|-6.96|=0.926
71111694|NCT03035864|141729875|SUPERIORITY||difference in least square means|-2.29|||=|0.426|TWO_SIDED|95.0|-7.97|3.38|||ANCOVA|||Frequency - Week 12||3.38|-7.97|=0.426
71111695|NCT03035864|141729875|SUPERIORITY||Difference in least square means|0.62|||=|0.828|TWO_SIDED|95.0|-5.04|6.29|||ANCOVA|||Severity - Week 4||6.29|-5.04|=0.828
71111696|NCT03035864|141729875|SUPERIORITY||difference in least square means|2.86|||=|0.394|TWO_SIDED|95.0|-3.75|9.47|||ANCOVA|||Severity - Week 8||9.47|-3.75|=0.394
71111697|NCT03035864|141729875|SUPERIORITY||difference in least square means|-1.49|||=|0.552|TWO_SIDED|95.0|-6.41|3.44|||ANCOVA|||Severeity - Week 12||3.44|-6.41|=0.552
71111698|NCT00480740|141729876|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of dexmedetomindine plus sevoflurane compared with the baseline (sevoflurane alone) for any given variable was reached when the difference (steady-state \[dexmedetomidine + sevoflurane\]-baseline \[sevoflurane0\]/baseline \[sevoflurane\]0 and its associated 95% confidence interval (CI) fell completely withing the range of +/-20% indicated by the gray column.||||||0.05||95.0||||The original study design was powered to achieve at least 80% power to detect noninferiority with the two-tailed alpha level set at 0.05 for data with two measurements.|t-test, 2 sided|||||||0.05
71111699|NCT01890265|141729885|SUPERIORITY||LS mean difference|4.33|||=|0.0331|TWO_SIDED|95.0|0.35|8.3||The analysis of the change from Baseline to Week 48 in FVC (% predicted) was based on the random coefficient regression model based on observed cases.|Random coefficient regression|||The absolute LS mean treatment difference (pamrevlumab - placebo) for change from Baseline to Week 48 in FVC (% predicted) is presented.||8.3|0.35|= 0.0331
71111700|NCT01890265|141729886|SUPERIORITY||LS mean difference|-1.8|||=|0.0236|TWO_SIDED|95.0|-3.3|-0.2|||ANCOVA with MI|||The absolute LS mean treatment difference (pamrevlumab - placebo) for change from Baseline to Week 24 in QLF score is presented.||-0.2|-3.3|= 0.0236
70938340|NCT01159600|141376654|SUPERIORITY_OR_OTHER||Mean difference|-1.99|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|97.5|-2.48|-1.5||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|ANCOVA with baseline HbA1c and baseline body weight as linear covariates and baseline eGFR, geographical region and treatment as fixed effects|Difference calculated as Met+SU: empa 25mg minus Met+SU: placebo|Null hypothesis: No difference in change from baseline to week 24 in body weight between Empagliflozin 25mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons (10mg vs placebo and 25mg vs placebo) within each background therapy group (metformin and metformin + SU). If for a specific dose the null hypothesis was rejected for the primary endpoint, the same dose was tested against placebo for the change from baseline in body weight.||-1.50|-2.48|<0.0001
70941775|NCT04748445|141383935|OTHER||Slope|0.000138|STANDARD_ERROR_OF_MEAN|6.614||0.039|TWO_SIDED|90.0|0.0000284|0.0002476|||Mixed Models Analysis|||READ\_MFCC 1st order delta 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-5).||0.0002476|0.00002840|0.0390
71065911|NCT02498444|141641211|OTHER|||||||0.3|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 24||||0.30
71065912|NCT02027545|141641212|SUPERIORITY|||||||0.491|||||||Regression, Logistic|||||||0.491
71065913|NCT02027545|141641213|SUPERIORITY|||||||0.049|||||||Regression, Logistic|||||||0.049
70941776|NCT04748445|141383935|OTHER||Slope|1.166|STANDARD_ERROR_OF_MEAN|1.04||0.2645|TWO_SIDED|90.0|-5.579|2.89|||Mixed Models Analysis|||READ\_MFCC 1st order delta 13 (The statistical data given below have (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-4. For lower limit it was 10\^-5).||2.890|-5.579|0.2645
71065914|NCT02453334|141641215|OTHER||Odds Ratio (OR)|0.51||||0.0143|TWO_SIDED|95.0|0.3|0.87|||Cochran-Mantel-Haenszel|||||0.87|0.30|0.0143
71065915|NCT02453334|141641215|OTHER||Percentage difference|-15.6|||||TWO_SIDED|95.0|-28.01|-3.1||||||||-3.10|-28.01|
71065916|NCT02453334|141641217|OTHER||Odds Ratio (OR)|2.04||||0.0097|TWO_SIDED|95.0|1.19|3.5|||Cochran-Mantel-Haenszel|||||3.50|1.19|0.0097
71065917|NCT02453334|141641217|OTHER||Percentage difference|16.4|||||TWO_SIDED|95.0|4.19|28.51||||||Percentage difference||28.51|4.19|
71065918|NCT02453334|141641218|OTHER||Percentage difference|-2.7|||||TWO_SIDED|95.0|-12.85|7.45||||||||7.45|-12.85|
71065919|NCT02453334|141641218|OTHER||Odds Ratio (OR)|0.83||||0.5758|TWO_SIDED|95.0|0.43|1.6|||Cochran-Mantel-Haenszel|||Placebo group was used as the denominator for odds ratio calculation.||1.60|0.43|0.5758
71065920|NCT02453334|141641219|OTHER||Odds Ratio (OR)|1.4||||0.2772|TWO_SIDED|95.0|0.76|2.56||Placebo group was used as the denominator for odds ratio calculation|Cochran-Mantel-Haenszel|||||2.56|0.76|0.2772
71065921|NCT02453334|141641219|OTHER||Percentage difference|5.7|||||TWO_SIDED|95.0|-5.01|16.43||||||||16.43|-5.01|
71065922|NCT02453334|141641220|OTHER|||||||0.0011|||||||Log Rank|P-value was estimated using logrank test stratified by country||||||0.0011
71065923|NCT02453334|141641221|OTHER||Percentage difference|0.7|||||TWO_SIDED|95.0|-7.6|9.08||||||||9.08|-7.60|
71065924|NCT02453334|141641221|OTHER||Odds Ratio (OR)|1.05||||0.8924|TWO_SIDED|95.0|0.49|2.29|||Cochran-Mantel-Haenszel|||||2.29|0.49|0.8924
71065925|NCT02453334|141641222|OTHER||Percentage difference|-9.8|||||TWO_SIDED|95.0|-20.41|0.77||||||||0.77|-20.41|
71065926|NCT02453334|141641222|OTHER||Odds Ratio (OR)|0.55||||0.074|TWO_SIDED|95.0|0.28|1.06|||Cochran-Mantel-Haenszel|Placebo group was used as the denominator for odds ratio calculation.||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country. Placebo group was used as the denominator for odds ratio calculation.||1.06|0.28|0.0740
71065927|NCT02453334|141641223|OTHER||Percentage difference|-12.1|||||TWO_SIDED|95.0|-23.31|-0.91||||||||-0.91|-23.31|
71065928|NCT02453334|141641223|OTHER||Odds Ratio (OR)|0.51||||0.0446|TWO_SIDED|95.0|0.26|0.99||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.|Cochran-Mantel-Haenszel|Placebo group was used as the denominator for odds ratio calculation||||0.99|0.26|0.0446
71065929|NCT02453334|141641224|OTHER||Percentage difference|-19.8|||||TWO_SIDED|95.0|-30.9|-8.69||||||||-8.69|-30.90|
71065930|NCT02453334|141641224|OTHER||Odds Ratio (OR)|0.3||||0.001|TWO_SIDED|95.0|0.14|0.63||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.|Cochran-Mantel-Haenszel|Placebo group was used as the denominator for odds ratio calculation.||||0.63|0.14|0.0010
71065931|NCT02453334|141641225|OTHER||Percentage difference|-21.4|||||TWO_SIDED|95.0|-33.22|-9.51||||||||-9.51|-33.22|
71065932|NCT02453334|141641225|OTHER||Odds Ratio (OR)|0.29||||0.0009|TWO_SIDED|95.0|0.13|0.61||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country|Cochran-Mantel-Haenszel||Placebo group was used as the denominator for odds ratio calculation.|||0.61|0.13|0.0009
71065933|NCT02453334|141641226|OTHER||Percentage difference|-16.0|||||TWO_SIDED|95.0|-27.73|-4.26||||||||-4.26|-27.73|
71065934|NCT02453334|141641226|OTHER||Odds Ratio (OR)|0.34||||0.0093|TWO_SIDED|95.0|0.14|0.79||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.|Cochran-Mantel-Haenszel||Placebo group was used as the denominator for odds ratio calculation.|||0.79|0.14|0.0093
71065935|NCT02453334|141641227|OTHER||Percentage difference|-4.4|||||TWO_SIDED|95.0|-15.37|6.57||||||||6.57|-15.37|
71065936|NCT02453334|141641227|OTHER||Odds Ratio (OR)|0.7||||0.4786|TWO_SIDED|95.0|0.26|1.89||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.|Cochran-Mantel-Haenszel||Placebo group was used as the denominator for odds ratio calculation.|||1.89|0.26|0.4786
71065937|NCT02453334|141641228|OTHER||Percentage difference|-7.4|||||TWO_SIDED|95.0|-19.25|4.55||||||||4.55|-19.25|
71065938|NCT02453334|141641228|OTHER||Odds Ratio (OR)|0.54||||0.2084|TWO_SIDED|95.0|0.2|1.43||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.|Cochran-Mantel-Haenszel||Placebo group was used as the denominator for odds ratio calculation.|||1.43|0.20|0.2084
71065939|NCT02453334|141641229|OTHER||Percentage difference|3.1|||||TWO_SIDED|95.0|-9.33|15.54||||||||15.54|-9.33|
70941777|NCT04748445|141383935|OTHER||Slope|-0.00119|STANDARD_ERROR_OF_MEAN|5.79||0.042|TWO_SIDED|90.0|-0.002149|-0.0002303|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0002303|-0.002149|0.0420
71065940|NCT02453334|141641229|OTHER||Odds Ratio (OR)|1.25||||0.6508|TWO_SIDED|95.0|0.48|3.24|||Cochran-Mantel-Haenszel|The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.|Placebo group was used as the denominator for odds ratio calculation.|||3.24|0.48|0.6508
71065941|NCT02453334|141641231|OTHER|||||||0.0063||||||P-value was estimated using logrank test stratified by pooled sites.|Log Rank|||||||0.0063
71065942|NCT00693498|141641235|OTHER||||||<|0.03||||||the reported value is for POD#1 assessment|Wald Wolfowitz|||||||<0.03
71065943|NCT00693498|141641235|OTHER|||||||0.29||||||for POD#2 assessment|Wald-Wolf|||||||0.29
71065944|NCT00302848|141641259|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations for VTE risk showed that 50,000 patients should be sufficient to exclude a twofold risk.|Hazard Ratio (HR)|1.0|||<|0.05||95.0|0.6|1.8|||Regression, Cox|||Null hypothesis: HR ≥ 2 (VTE of DRSP vs. LNG)||1.8|0.6|<0.05
71065945|NCT00676364|141641337|NON_INFERIORITY_OR_EQUIVALENCE|We determined that we will need to enroll 43 children in each group, for a power of .80, alpha=0.05. We used a per protocol analysis.|Mean Difference (Final Values)|2.1||||0.71|||||||Chi-squared||To assess the association between pain and anxiety with intervention group while controlling for other factors, linear regression was used.|P-value determined from linear regression models that include age, gender, number of needle sticks in previous 2 years and nurse reported difficulty in performing venipuncture.||||0.71
71065946|NCT00402688|141641338|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is a risk difference of 0.2.|Risk Difference (RD)|0.063||||||95.0|-0.089|0.215|||||Difference in success rates (levofloxacin 500mg for 4 weeks minus levofloxacin 750mg for 2 weeks ).|||0.215|-0.089|
71065947|NCT00402688|141641338|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is a risk difference of 0.2.|Risk Difference (RD)|0.045||||||95.0|-0.106|0.195|||||Difference in success rates (levofloxacin 500mg for 4 weeks minus levofloxacin 750mg for 3 weeks).|||0.195|-0.106|
71065948|NCT04157296|141641362|SUPERIORITY||Mean Difference (Final Values)|-0.226|||||TWO_SIDED|||||||||leftIFG (Change in Brain activity \[post minus pre\])||||
71065949|NCT04157296|141641362|SUPERIORITY||Median Difference (Final Values)|-0.309|||||TWO_SIDED|||||||||rightIFG (Change in Brain activity \[post minus pre\])||||
71065950|NCT04157296|141641362|SUPERIORITY||Mean Difference (Final Values)|-0.179|||||TWO_SIDED|||||||||leftParietal (Change in Brain activity \[post minus pre\])||||
71065951|NCT04157296|141641362|SUPERIORITY||Mean Difference (Final Values)|0.324|||||TWO_SIDED|||||||||rightParietal (Change in Brain activity \[post minus pre\])||||
71065952|NCT04157296|141641362|SUPERIORITY||Mean Difference (Final Values)|0.41|||||TWO_SIDED|||||||||leftdACC (Change in Brain activity \[post minus pre\])||||
70941778|NCT04748445|141383935|OTHER||Slope|-4.504|STANDARD_ERROR_OF_MEAN|3.04||0.141|TWO_SIDED|90.0|-9.542|5.341|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 02 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit, estimated value and dispersion value it was 10\^-4. For upper limit it was 10\^-5).||5.341|-9.542|0.1410
71065953|NCT04157296|141641362|SUPERIORITY||Mean Difference (Final Values)|-0.067|||||TWO_SIDED|||||||||rightdACC (Change in Brain activity \[post minus pre\])||||
71065954|NCT04157296|141641362|SUPERIORITY||Mean Difference (Final Values)|0.302|||||TWO_SIDED|||||||||leftInsula (Change in Brain activity \[post minus pre\])||||
71065955|NCT04157296|141641362|SUPERIORITY|rightInsula (Change in Brain activity \[post minus pre\])|Mean Difference (Final Values)|0.234|||||TWO_SIDED|||||||||rightInsula (Change in Brain activity \[post minus pre\])||||
71065956|NCT04157296|141641362|SUPERIORITY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|||||||||TCN (Change in Connectivity \[post minus pre\])||||
71065957|NCT04157296|141641363|SUPERIORITY|||||||0.241|||||||t-test, 1 sided|||||||0.241
71065958|NCT04157296|141641364|SUPERIORITY|||||||0.233|||||||t-test, 1 sided|||||||0.233
71065959|NCT04157296|141641365|SUPERIORITY|||||||0.042|||||||t-test, 1 sided|||||||0.042
71065960|NCT04157296|141641366|SUPERIORITY|||||||0.349|||||||t-test, 1 sided|||||||0.349
71065961|NCT02237196|141641367|SUPERIORITY||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.5038||0.314|TWO_SIDED|95.0|-1.51|0.49|||Longitudinal repeated measures analysis|Model adjusts for Site, Baseline TNSS AUC, and Baseline Cat exposure (low vs high)||||0.49|-1.51|0.314
71065962|NCT03980145|141641377|SUPERIORITY|||||||0.405||||||Statistical significance set at .05|ANOVA|||Null hypothesis is no difference between the two groups||||.405
71065963|NCT03980145|141641377|SUPERIORITY|||||||0.133|||||||ANOVA|||Null hypothesis is no difference between pretest and posttest||||.133
71065964|NCT03980145|141641377|SUPERIORITY|||||||0.05|||||||ANOVA|||Evaluated the difference between the pretest and posttest within the conventional physical therapy group||||.050
71065965|NCT03980145|141641377|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.017|TWO_SIDED|95.0|0.015|0.124||p value was adjusted for multiple comparisons using a Bonferroni correction|ANOVA|||Evaluating the impact of whether comfortable walking speed for both groups combined resulted in a significant improvement in walking speed||.124|.015|.017
71065966|NCT03980145|141641378|SUPERIORITY|||||||0.369|||||||ANOVA|||Comparison of the impact between the two arms looking an improved walking endurance||||.369
71065967|NCT03980145|141641378|SUPERIORITY|||||||0.71|||||||ANOVA|||Evaluation of impact of end-effector robotic training alone||||.710
71065968|NCT03980145|141641378|SUPERIORITY|||||||0.682|||||||ANOVA|||Evaluating the impact of conventional therapy on walking endurance Null hypothesis is no difference between pretest and posttest||||.682
71065969|NCT03980145|141641378|SUPERIORITY|||||||0.568||||||p value adjusted for multiple comparisons - Bonferroni|ANOVA|||Evaluating the impact of whether both groups combined resulted in a significant change in walking distance||||.568
71065970|NCT03980145|141641379|SUPERIORITY|||||||0.594||||||Outcome specific to the physical domain|ANOVA|||Evaluation of the physical domain||||.594
71065971|NCT03980145|141641379|SUPERIORITY|||||||0.061|||||||ANOVA|||Pretest- Posttest End Effector Robotic Training Comparison for the Physical Domain||||.061
71065972|NCT03980145|141641379|SUPERIORITY|||||||0.812|||||||ANOVA|||Pretest posttest comparison of conventional training group for physical domain||||.812
71065973|NCT03980145|141641379|SUPERIORITY|||||||0.235|||||||ANOVA|||Combined conventional and end-effector training for outcomes in the physical domain||||.235
71065974|NCT03980145|141641379|SUPERIORITY|||||||0.465|||||||ANOVA|||Between group assessment of changes in the MFIS Cognitive domain||||.465
70852704|NCT01578850|141194334|SUPERIORITY_OR_OTHER||Difference in proportions|9.0||||0.088|TWO_SIDED|95.0|1.02|16.88|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Remission: Week 52||16.88|1.02|0.088
70941779|NCT04748445|141383935|OTHER||Slope|2.968|STANDARD_ERROR_OF_MEAN|3.334||0.3751|TWO_SIDED|90.0|-2.557|8.492|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||8.492|-2.557|0.3751
71065975|NCT03980145|141641379|SUPERIORITY|||||||0.165|||||||ANOVA|||Within group differences for the End Effector Robotic Training Group for the Cognitive Domain||||.165
71065976|NCT03980145|141641379|SUPERIORITY|||||||0.682|||||||ANOVA|||Within group assessment for the conventional group within the cognitive domain of the MFIS||||.682
71065977|NCT03980145|141641379|SUPERIORITY||Mean Difference (Final Values)|5.39||||0.017|TWO_SIDED|95.0|1.12|9.67||p value adjusted using a Bonferroni correction|ANOVA|||Combined group outcomes comparing pretest to posttest for the cognitive domain||9.67|1.12|.017
71065978|NCT03980145|141641379|SUPERIORITY|||||||0.052|||||||ANOVA|||Between group comparison for the MFIS Psychological Subscale||||.052
71065979|NCT03980145|141641379|SUPERIORITY|||||||0.483|||||||ANOVA|||Within group comparison for the end-effector robotic training group for the MFIS Psychological subscale||||.483
71065980|NCT03980145|141641379|SUPERIORITY|||||||0.056|||||||ANOVA|||Within group assessment for the conventional physical therapy group for the MFIS Psychological subscale||||.056
71065981|NCT03980145|141641379|SUPERIORITY||Mean Difference (Final Values)|1.313||||0.048|TWO_SIDED|95.0|0.016|2.619||p value is adjusted for multiple comparisons using a Bonferroni correction|ANOVA|||Change in MFIS for all subjects from pre to posttest for the psychological subscale||2.619|.016|.048
71065982|NCT03980145|141641379|SUPERIORITY|||||||0.01|||||||ANOVA|||Between group assessment of differences in total score||||.010
71065983|NCT03980145|141641379|SUPERIORITY|||||||0.089|||||||ANOVA|||Within assessment of change in total fatigue score||||.089
71065984|NCT03980145|141641379|SUPERIORITY|||||||0.5|||||||ANOVA|||Within group assessment of change in total score||||.50
71065985|NCT03980145|141641379|SUPERIORITY||Mean Difference (Final Values)|9.464||||0.1|TWO_SIDED|95.0|2.678|16.251|||ANOVA|||Combined assessment of all subject improvement in total MFIS score||16.251|2.678|0.10
71065986|NCT03980145|141641380|SUPERIORITY|||||||0.071|||||||ANOVA|||Null hypothesis set for no difference between groups Assessment of between group differences for the physical subscale||||.071
70852705|NCT01578850|141194334|SUPERIORITY_OR_OTHER||Difference in proportions|0.6||||0.358|TWO_SIDED|95.0|-0.59|1.81|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: LDA: Baseline||1.81|-0.59|0.358
71065987|NCT03980145|141641380|SUPERIORITY||Mean Difference (Final Values)|14.84||||0.005|TWO_SIDED|95.0|6.02|23.66|||ANOVA|||With group assessment of change on the physical subscale of the MSIS||23.66|6.02|.005
71065988|NCT03980145|141641380|SUPERIORITY||Mean Difference (Final Values)|13.57||||0.001|TWO_SIDED|95.0|8.3|18.85|||ANOVA|||With group assessment of change on the physical subscale of the MSIS||18.85|8.30|.001
71065989|NCT03980145|141641380|SUPERIORITY||Mean Difference (Final Values)|14.21||||2.6e-05|TWO_SIDED|95.0|9.367|19.04||p value adjusted for multiple comparisons using Bonferroni|ANOVA|||Combined group assessment of change on the physical subscale of the MSIS||19.04|9.367|.000026
71065990|NCT03980145|141641380|SUPERIORITY|||||||0.084||||||Pretest measures were statistically different between the two groups|ANOVA|||Between group comparison for the psychological subscale for the MSIS||||.084
71065991|NCT03980145|141641380|SUPERIORITY|||||||0.412|||||||ANOVA|||Within group comparison for the psychological subscale for the MSIS||||.412
71065992|NCT03980145|141641380|SUPERIORITY||Mean Difference (Final Values)|22.22||||0.00018|TWO_SIDED|95.0|15.59|28.85|||ANOVA|||Within group comparison for the psychological subscale for the MSIS||28.85|15.59|.00018
71065993|NCT03980145|141641380|SUPERIORITY||Mean Difference (Final Values)|13.19||||0.00049|TWO_SIDED|95.0|7.013|19.38|||ANOVA|||Combined group comparison for the psychological subscale for the MSIS||19.38|7.013|.00049
71065994|NCT03980145|141641381|SUPERIORITY|||||||0.352|||||||ANOVA|||Null hypothesis is no difference between the two groups||||.352
71065995|NCT03980145|141641381|SUPERIORITY|||||||0.079|||||||ANOVA|||Within group assessment||||.079
71065996|NCT03980145|141641381|SUPERIORITY|||||||0.393|||||||ANOVA|||Within group assessment||||.393
71065997|NCT03980145|141641381|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.048|TWO_SIDED|95.0|0.001|0.116|||ANOVA|Adjusted for multiple mean comparisons||Evaluating the impact of whether fast walking speed for both groups combined resulted in a significant improvement in walking speed||.116|.001|.048
71065998|NCT03980145|141641382|SUPERIORITY|||||||0.117|||||||ANOVA|||Between group assessment for the HADS Anxiety Subscale||||.117
71065999|NCT03980145|141641382|SUPERIORITY||Mean Difference (Final Values)|1.75||||0.041|TWO_SIDED|95.0|0.093|3.407|||ANOVA|||Within group assessment for HADS Anxiety Subscale||3.407|.093|.041
71066000|NCT03980145|141641382|SUPERIORITY|||||||0.15|||||||ANOVA|||Within group assessment for HADS Anxiety Subscale||||.150
71066001|NCT03980145|141641382|SUPERIORITY||Mean Difference (Final Values)|1.518||||0.012|TWO_SIDED|95.0|0.39|2.646||p value adjusted for multiple comparisons|ANOVA|||Combined group assessment of HADS Anxiety Subscale||2.646|.390|.012
71066002|NCT03980145|141641383|SUPERIORITY|||||||0.239|||||||ANOVA|||||||.239
71066003|NCT03980145|141641383|SUPERIORITY|||||||0.667|||||||ANOVA|||Comparison between groups for differences in sensory pain score||||.667
71066004|NCT03980145|141641383|SUPERIORITY|||||||0.77|||||||ANOVA|||Between group differences in affective pain||||.770
71066005|NCT03980145|141641384|SUPERIORITY|||||||0.136|||||||ANOVA|||Between group assessment of LLFDI Disability Frequency||||.136
71066006|NCT03980145|141641384|SUPERIORITY|||||||0.833|||||||ANOVA|||Combined group assessment of improvement in LLFDI Disability Frequency||||.833
71066007|NCT03980145|141641384|SUPERIORITY||Mean Difference (Final Values)|6.996||||0.044|TWO_SIDED|95.0|0.212|13.781|||ANOVA|||Between Group Assessment of improvement in LLFDI Disability Limitations||13.781|.212|.044
71066008|NCT03980145|141641384|SUPERIORITY|||||||0.212|||||||ANOVA|||Combined group assessment of improvement in LLFDI Disability Limitations||||.212
71066009|NCT03980145|141641385|SUPERIORITY|||||||0.338|||||||ANOVA|||Between group comparison for the LLDFI Function||||.338
71111701|NCT01890265|141729886|SUPERIORITY||LS mean difference|-3.2|||=|0.0729|TWO_SIDED|95.0|-6.6|0.3|||ANCOVA with MI|||The absolute LS mean treatment difference (pamrevlumab - placebo) for change from Baseline to Week 48 in QLF score is presented.||0.3|-6.6|= 0.0729
71111702|NCT01890265|141729887|SUPERIORITY||Absolute difference|-21.4|||=|0.0133|TWO_SIDED|95.0|-36.6|-6.2|||Regression, Logistic|||The absolute treatment difference (pamrevlumab - placebo) for percentage of participants with IPF progression at Week 48 is presented.||-6.2|-36.6|= 0.0133
71111703|NCT02881775|141729903|SUPERIORITY|||||||0.9994||||||The threshold for significance was P \<.05|ANOVA|"Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors.~Degrees of freedom (DF) = 34.1"||Comparison of CAR BL Change (treatment by time)||||.9994
70938341|NCT01159600|141376655|SUPERIORITY_OR_OTHER||Mean difference|-7.65|STANDARD_ERROR_OF_MEAN|2.74||0.0055|TWO_SIDED|97.5|-13.81|-1.48||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c and baseline MDG as linear covariates and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met: empa 10mg minus Met: placebo|Null hypothesis (H0): No difference in change from baseline to week 24 in MDG between Empa 10mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons within each background therapy group. If for a specific dose H0 was rejected for the primary endpoint, the same dose was tested against placebo for change from baseline in body weight. If superiority over placebo was shown at this gate level, then testing proceeded to change from baseline in MDG with that dose||-1.48|-13.81|0.0055
71111704|NCT02881775|141729904|SUPERIORITY|||||||0.9768||||||The threshold for statistical significance was p \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 45||Comparison of MVIC BL Change (treatment by time)||||.9768
71111705|NCT02881775|141729905|SUPERIORITY|||||||0.444||||||threshold for statistical significance is p \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 43.1||Comparison of NPRS BL Change (treatment by time)||||0.4440
71111706|NCT02881775|141729906|SUPERIORITY|||||||0.6608||||||Threshold for statistical significance is P \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 45||PPT BL Change (treatment by time)||||.6608
71111707|NCT02881775|141729907|SUPERIORITY|||||||0.7706||||||Threshold for statistical significance is P \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 45||Comparison of TUG BL Change (treatment by time)||||.7706
71111708|NCT02881775|141729908|SUPERIORITY|||||||0.3665||||||Threshold for statistical significance is P \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 33||Comparison of AMT-MEP BL Change (treatment by time)||||.3665
71111709|NCT02881775|141729909|SUPERIORITY|||||||0.3889||||||Threshold for statistical significance is P \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 33||Comparison of SICI BL Change (treatment by time)||||.3889
71111710|NCT02881775|141729910|SUPERIORITY|||||||0.2192||||||Threshold for statistical significance is P \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 33||Comparison of ICF BL Change (treatment by time)||||.2192
71111711|NCT00809926|141729911|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.6||||0.295|TWO_SIDED|95.0|-4.61|1.4|||ANCOVA|||||1.40|-4.61|0.295
71111712|NCT00809926|141729912|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.2||||0.79|TWO_SIDED|95.0|-1.93|1.47|||ANCOVA|||||1.47|-1.93|0.790
71111713|NCT00809926|141729913|SUPERIORITY_OR_OTHER||Difference|8.1||||0.101|TWO_SIDED|95.0|-1.56|17.67|||Cochran-Mantel-Haenszel|||||17.67|-1.56|0.101
71111714|NCT00809926|141729914|SUPERIORITY_OR_OTHER||Difference|11.6||||0.018|TWO_SIDED|95.0|2.0|21.33|||Cochran-Mantel-Haenszel|||||21.33|2.00|0.018
71111715|NCT00809926|141729917|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.4||||0.028|TWO_SIDED|95.0|-6.34|-0.37|||ANCOVA|||||-0.37|-6.34|0.028
71111716|NCT00809926|141729918|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.1||||0.04|TWO_SIDED|95.0|-6.02|-0.14|||GENMOD|Based on a generalized estimating equations using SAS procedure GENMOD.||||-0.14|-6.02|0.040
71111717|NCT00809926|141729919|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-8.7||||0.004|TWO_SIDED|95.0|-14.38|-2.93|||ANCOVA|||||-2.93|-14.38|0.004
71111718|NCT00809926|141729920|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-4.9||||0.006|TWO_SIDED|95.0|-8.37|-1.42|||ANCOVA|||||-1.42|-8.37|0.006
71111719|NCT01198574|141729948|SUPERIORITY_OR_OTHER||||||<|0.05|||||||GLM for repeated measures|The Hb concentration at Week 0, Week 6 and Week 12 are analyzed using GLM repeated measures.||"Null Hypothesis~1. Haemoglobin level was not influenced by sub-clinical inflammation during iron supplementation in the anaemic adolescent school girls~2. Vitamin A does not improve the haemoglobin level of the anaemic schoolgirls during iron supplementation in the presence of inflammation."||||<0.05
71111720|NCT01198574|141729949|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||GLM for repeated measures ANOVA|||"Null hypothesis~1. Iron status indicator (serum ferritin) was not influenced by sub-clinical inflammation during iron supplementation in the anaemic adolescent school girls~2. Vitamin A does not improve the iron status indicator (serum ferritin) concentration of the anaemic schoolgirls during iron supplementation in the presence of inflammation."||||<0.05
71111721|NCT01198574|141729950|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||GLM for repeated measures ANOVA|||"Null Hypothesis~1. iron status indicator (sTfR) was not influenced by sub-clinical inflammation during iron supplementation in the anaemic adolescent school girls~2. Vitamin A does not improve iron status indicator (sTfR) of the anaemic schoolgirls during iron supplementation in the presence of inflammation."||||<0.05
70941780|NCT04748445|141383935|OTHER||Slope|-0.0000796|STANDARD_ERROR_OF_MEAN|2.101||0.7053|TWO_SIDED|90.0|-0.0004277|0.0002685|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0002685|-0.0004277|0.7053
71066010|NCT03980145|141641385|SUPERIORITY||Mean Difference (Final Values)|7.508||||0.007|TWO_SIDED|95.0|2.73|12.28|||ANOVA|||Within group assessment of LLFDI Function||12.28|2.73|.007
71066011|NCT03980145|141641385|SUPERIORITY|||||||0.067|||||||ANOVA|||Within group assessment for changes in LLFDI Function||||.067
71066012|NCT03980145|141641385|SUPERIORITY||Mean Difference (Final Values)|5.99||||0.001|TWO_SIDED|95.0|2.9|9.08||p value adjusted for multiple comparisons|ANOVA|||Combined group improvement in LLFDI Function||9.08|2.90|.001
71066013|NCT00863343|141641403|SUPERIORITY_OR_OTHER||Sensitivity|0.82|||||TWO_SIDED|95.0|0.59|0.94|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||0.94|0.59|
71066014|NCT00863343|141641403|SUPERIORITY_OR_OTHER||Specificity|0.987|||||TWO_SIDED|95.0|0.97|0.99|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||0.99|0.97|
71066015|NCT00863343|141641404|SUPERIORITY_OR_OTHER||Sensitivity|0.81|||||TWO_SIDED|95.0|0.63|0.92|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||0.92|0.63|
71066016|NCT00863343|141641404|SUPERIORITY_OR_OTHER||Specificity|0.997|||||TWO_SIDED|95.0|0.98|1.0|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||1.0|0.98|
71066017|NCT00863343|141641405|SUPERIORITY_OR_OTHER||Sensitivity|0.88|||||TWO_SIDED|95.0|0.7|0.96|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||0.96|0.70|
71066018|NCT00863343|141641405|SUPERIORITY_OR_OTHER||Specificity|0.997||||||95.0|0.98|1.0|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||1.0|0.98|
71066019|NCT00863343|141641406|SUPERIORITY_OR_OTHER||Sensitivity|0.79|||||TWO_SIDED|95.0|0.6|0.9|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||0.90|0.60|
71066020|NCT00863343|141641406|SUPERIORITY_OR_OTHER||Specificity|0.997|||||TWO_SIDED|95.0|0.98|1.0|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||1.0|0.98|
71066021|NCT01421225|141641407|EQUIVALENCE|The null hypothesis was that the number of hours would be the same (no effect of control).|Mean Difference (Final Values)|2.2||||0.12|TWO_SIDED|||||Statistical analysis was performed using a paired t-test.|t-test, 2 sided|||We tested the number of nighttime (10 PM - 8 AM) hours glucose was in the target range (110-200 mg/dL) on each of the two nights for which the patient was followed (one night under Standard Insulin Pump Therapy; one night under Closed-loop Insulin Therapy)||||0.12
71066022|NCT01322490|141641411|SUPERIORITY|One-sided p-value is from a stratified log-rank test for PROSTVAC-V/F-TRICOM + GM-CSF placebo vs. Placebo Control with Treatment Arm included in model. Stratification is by randomization strata.||||||0.4742||||||The overall type-one error probability for the entire trial was designed as a one-sided P=0.025. There were two main overall comparisons, which necessitated a type-one error probability to 0.0125 for each comparison using a Bonferroni correction.|Log Rank|The primary analysis method was a stratified log-rank test, and was performed using the ITT Set analyzing data according to the randomized arm.||||||0.4742
71111722|NCT00325130|141729958|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -5%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
71066023|NCT01322490|141641411|SUPERIORITY|One-sided p-value is from a stratified log-rank test for PROSTVAC-V/F-TRICOM + GM-CSF vs. Placebo Control with Treatment Arm included in model. Stratification is by randomization strata.||||||0.5885||||||The overall type-one error probability for the entire trial was designed as a one-sided P=0.025. There were two main overall comparisons, which necessitated a type-one error probability to 0.0125 for each comparison using a Bonferroni correction.|Log Rank|The primary analysis method was a stratified log-rank test, and was performed using the ITT Set analyzing data according to the randomized arm.||||||0.5885
71066024|NCT01322490|141641412|SUPERIORITY|Odds Ratio and Wald 95% CI estimates are for odds of alive without event for PROSTVAC-V/F-TRICOM + GM-CSF placebo vs. Placebo Control and are from a logistic regression model with Treatment Arm included in model stratified by randomization strata.|Odds Ratio (OR)|0.9588|||||TWO_SIDED|95.0|0.7144|1.2867|||||The Alive Without Event endpoint was analyzed using stratified logistic regression. The 95% CI on the odds ratio estimate was computed as the measure of the magnitude of effect.|||1.2867|0.7144|
71066025|NCT01322490|141641412|SUPERIORITY|Odds Ratio and Wald 95% CI estimates are for odds of alive without event for PROSTVAC-V/F-TRICOM + GM-CSF vs. Placebo Control and are from a logistic regression model with Treatment Arm included in model stratified by randomization strata.|Odds Ratio (OR)|0.8941|||||TWO_SIDED|95.0|0.6647|1.2026|||||The Alive Without Event endpoint was analyzed using stratified logistic regression. The 95% CI on the odds ratio estimate was computed as the measure of the magnitude of effect.|||1.2026|0.6647|
71066026|NCT01342523|141641428|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.825|TWO_SIDED|95.0|0.88|1.17||P-value is not adjusted for multiple comparisons.|Regression, Logistic|The logistic regression model included all 5 treatment main effects and the 10 two-way interactions as well as gender, race, and age as covariates.||Null hypothesis: No difference in 3-month abstinence rates for participants receiving CIS vs No CIS. We hypothesized that CIS would result in significantly higher abstinence rates compared to No CIS.||1.17|0.88|.825
71066027|NCT01342523|141641428|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.028|TWO_SIDED|95.0|1.02|1.36||P-value is not adjusted for multiple comparisons|Regression, Logistic|The logistic regression model included all 5 treatment main effects and the 10 two-way interactions as well as gender, race, and age as covariates.||Null hypothesis: No difference in 3-month abstinence rates for participants receiving NRT vs No NRT. We hypothesized that NRT would result in significantly higher abstinence rates compared to No NRT.||1.36|1.02|.028
71066028|NCT01342523|141641428|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.755|TWO_SIDED|95.0|0.85|1.13||P-value is not adjusted for multiple comparisons|Regression, Logistic|The logistic regression model included all 5 treatment main effects and the 10 two-way interactions as well as gender, race, and age as covariates.||Null hypothesis: No difference in 3-month abstinence rates for participants receiving Email Messaging vs No Email Messaging. We hypothesized that Email Messaging would result in significantly higher abstinence rates compared to No Email Messaging.||1.13|0.85|.755
71066029|NCT01342523|141641428|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.057|TWO_SIDED|95.0|0.996|1.33||P-value is not adjusted for multiple comparisons|Regression, Logistic|The logistic regression model included all 5 treatment main effects and the 10 two-way interactions as well as gender, race, and age as covariates.||Null hypothesis: No difference in 3-month abstinence rates for participants receiving the Full SmokeFree.gov Website vs the Lite SmokeFree.gov Website . We hypothesized that the Full SmokeFree.gov Website would result in significantly higher abstinence rates compared to the LiteSmokeFree.gov Website .||1.33|0.996|.057
71066030|NCT01342523|141641428|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.555||95.0|0.83|1.11||P-value is not adjusted for multiple comparisons|Regression, Logistic|The logistic regression model included all 5 treatment main effects and the 10 two-way interactions as well as gender, race, and age as covariates.||Null hypothesis: No difference in 3-month abstinence rates for participants receiving the Full Cessation Booklet vs the Brief Cessation Booklet We hypothesized that the Full Cessation Booklet would result in significantly higher abstinence rates compared to the Brief Cessation Booklet.||1.11|0.83|.555
71066031|NCT01422889|141641438|SUPERIORITY_OR_OTHER||percentage|2.2|||||TWO_SIDED|||||A p-value was not calculated for the ION Registry 12 month cardiac events. For the protocol specified primary endpoint analysis including data pooled from the PERSEUS SV, PERSEUS WH and TE Prove patient populations please see the citations.||||2.2% (23/1028) of ION Registry subjects experienced CD/MI related to the ION stent at 12 months||||
71066032|NCT01422889|141641439|SUPERIORITY_OR_OTHER||percentage|2.6|||||ONE_SIDED|||||A p-value was not calculated for the ION Registry 2 year cardiac events. For the protocol specified secondary endpoint analysis including data pooled from the PERSEUS SV, PERSEUS WH and TE Prove patient populations please see the citations.||||2.6% (27/1054) of ION Registry subjects experienced ARC ST Definite/Probable related to the ION stent at 2 years.||||
71066033|NCT00665431|141641468|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority margin (NI) margin of 10mm between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-5.94|3.34|||ANCOVA|||||3.34|-5.94|
71066034|NCT00665431|141641469|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority (NI) margin of 10mm between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|-2.11|||||TWO_SIDED|95.0|-6.82|2.6|||ANCOVA|||||2.60|-6.82|
71066035|NCT00665431|141641470|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority (NI) margin of 10mm between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|3.45|||||TWO_SIDED|95.0|-1.41|8.31|||ANCOVA|||||8.31|-1.41|
71066036|NCT01329380|141641484|OTHER|||||||0.0328|||||||Mann-Whitney U-test|||Age||||0.0328
71066037|NCT01329380|141641484|OTHER|||||||0.7128|||||||Fisher Exact|||Sex||||0.7128
71066038|NCT01329380|141641484|OTHER|||||||0.0465|||||||Mann-Whitney U-test|||Body mass index||||0.0465
71066039|NCT01329380|141641484|OTHER|||||||0.8872|||||||Mann-Whitney U-test|||Duration of illness||||0.8872
71066040|NCT01329380|141641484|OTHER|||||||0.0388|||||||Fisher Exact|||Smoking history||||0.0388
71066041|NCT01329380|141641484|OTHER|||||||0.4855|||||||Fisher Exact|||Complications||||0.4855
71066042|NCT01329380|141641484|OTHER|||||||0.663|||||||Fisher Exact|||Complications - Liver disorder||||0.6630
71066043|NCT01329380|141641484|OTHER|||||||0.2067|||||||Fisher Exact|||Complications - Renal disorder||||0.2067
71066044|NCT01329380|141641484|OTHER|||||||0.8749|||||||Fisher Exact|||Complications - Cardiovascular disorder||||0.8749
71066045|NCT01329380|141641484|OTHER|||||||0.482|||||||Fisher Exact|||Complications - Blood disorder||||0.4820
71066046|NCT01329380|141641484|OTHER|||||||0.6355|||||||Fisher Exact|||Complications - Respiratory disorder||||0.6355
71066047|NCT01329380|141641484|OTHER|||||||0.8193|||||||Fisher Exact|||Complications - Diabetes mellitus||||0.8193
71066048|NCT01329380|141641484|OTHER|||||||0.5723|||||||Fisher Exact|||Complications - Uveitis||||0.5723
71066049|NCT01329380|141641484|OTHER|||||||1|||||||Fisher Exact|||Complications - Inflammatory bowel disease||||1.0000
71066050|NCT01329380|141641484|OTHER|||||||1|||||||Fisher Exact|||Complications - Psoriasis||||1.0000
71066051|NCT01329380|141641484|OTHER|||||||0.0144|||||||Fisher Exact|||Past Illnesses||||0.0144
71066052|NCT01329380|141641484|OTHER|||||||1|||||||Fisher Exact|||Allergy history||||1.0000
71066053|NCT01329380|141641484|OTHER|||||||0.3928|||||||Fisher Exact|||Adalimumab self-injection status||||0.3928
71066054|NCT01329380|141641484|OTHER|||||||0.2735|||||||Fisher Exact|||Prior medications - NSAIDs||||0.2735
71066055|NCT01329380|141641484|OTHER|||||||0.8875|||||||Fisher Exact|||Prior medications - Biological products||||0.8875
71066056|NCT01329380|141641484|OTHER|||||||0.254|||||||Fisher Exact|||Prior medications - Adrenal corticosteroids||||0.2540
71066057|NCT01329380|141641484|OTHER|||||||0.0226|||||||Fisher Exact|||Concomitant drugs||||0.0226
71066058|NCT01329380|141641484|OTHER|||||||1|||||||Fisher Exact|||Concomitant drug: NSAIDs||||1.0000
71066059|NCT01329380|141641484|OTHER|||||||0.2481|||||||Fisher Exact|||Concomitant drugs - DMARDs||||0.2481
71066060|NCT01329380|141641484|OTHER|||||||0.1558|||||||Fisher Exact|||Concomitant drugs - Methotrexate||||0.1558
71066061|NCT01329380|141641484|OTHER|||||||1|||||||Fisher Exact|||Concomitant drugs - salazosulfapyridine||||1.0000
71066062|NCT01329380|141641484|OTHER|||||||0.0094|||||||Fisher Exact|||Concomitant drugs - Adrenal corticosteroids||||0.0094
71066063|NCT01329380|141641484|OTHER|||||||1|||||||Fisher Exact|||Concomitant therapy||||1.0000
70938342|NCT01159600|141376655|SUPERIORITY_OR_OTHER||Mean difference|-12.37|STANDARD_ERROR_OF_MEAN|2.75|<|0.0001|TWO_SIDED|97.5|-18.55|-6.19||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c and baseline MDG as linear covariates and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met: empa 25mg minus Met: placebo|Null hypothesis (H0): No difference in change from baseline to week 24 in MDG between Empa 25mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons within each background therapy group. If for a specific dose H0 was rejected for the primary endpoint, the same dose was tested against placebo for change from baseline in body weight. If superiority over placebo was shown at this gate level, then testing proceeded to change from baseline in MDG with that dose||-6.19|-18.55|<0.0001
70938343|NCT01159600|141376655|SUPERIORITY_OR_OTHER||Mean difference|-10.02|STANDARD_ERROR_OF_MEAN|2.53|<|0.0001|TWO_SIDED|97.5|-15.72|-4.32||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c and baseline MDG as linear covariates and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met+SU: empa 10mg minus Met+SU: placebo|Null hypothesis (H0): No difference in change from baseline to week 24 in MDG between Empa 10mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons within each background therapy group. If for a specific dose H0 was rejected for the primary endpoint, the same dose was tested against placebo for change from baseline in body weight. If superiority over placebo was shown at this gate level, then testing proceeded to change from baseline in MDG with that dose||-4.32|-15.72|<0.0001
70938344|NCT01159600|141376655|SUPERIORITY_OR_OTHER||Mean difference|-13.06|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|97.5|-19.15|-6.98||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c and baseline MDG as linear covariates and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met+SU: empa 25mg minus Met+SU: placebo|Null hypothesis (H0): No difference in change from baseline to week 24 in MDG between Empa 25mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons within each background therapy group. If for a specific dose H0 was rejected for the primary endpoint, the same dose was tested against placebo for change from baseline in body weight. If superiority over placebo was shown at this gate level, then testing proceeded to change from baseline in MDG with that dose||-6.98|-19.15|<0.0001
70938345|NCT01159600|141376656|SUPERIORITY_OR_OTHER||Mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.72|-0.42||Each of the hypotheses (10mg vs placebo and 25mg vs. placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c as a linear covariate and baseline eGFR (renal function), geographical region and treatment as fixed effects.|Difference calculated as Met: empa 10mg minus Met: placebo|Null hypothesis: No difference in change from baseline to week 24 in HbA1c between Empagliflozin 10mg and placebo. The study consisted of two substudies as defined by the two background medications 'metformin' and 'metformin + SU'. Within each group of background medication, each of the two hypotheses (10mg vs placebo and 25mg vs. placebo) was tested in a two-sided test.||-0.42|-0.72|<0.0001
71066064|NCT01329380|141641484|OTHER|||||||0.8836|||||||Fisher Exact|||Human leukocyte antigen B27 (HLA-B27) test result||||0.8836
71066065|NCT01329380|141641484|OTHER|||||||1|||||||Fisher Exact|||BASDAI at start of treatment||||1.0000
71066066|NCT02915705|141641508|SUPERIORITY||LS Mean Difference|1.14|||<|0.0001|TWO_SIDED|95.0|0.83|1.45|||ANCOVA|||Least squares (LS) mean, standard error (SE), confidence interval (CI), and 2-sided p value per ANCOVA model, which included RGI-C as the dependent variable, treatment group and baseline age stratification factor as independent variables and baseline RSS score as a continuous covariate.||1.45|0.83|< 0.0001
71066067|NCT02915705|141641509|SUPERIORITY||Odds Ratio (OR)|39.1|||<|0.0001|TWO_SIDED|95.0|7.2|211.7||Odds ratio, CI, and 2-sided p-value were per logistic regression model, which included treatment group and baseline age stratification factor as independent variables and baseline RSS score as a continuous covariate.|Regression, Logistic|||||211.7|7.2|< 0.0001
71066068|NCT02915705|141641510|SUPERIORITY||Odds Ratio (OR)|34.1||||0.0002|TWO_SIDED|95.0|5.6|206.3||Odds ratio, CI, and 2-sided p-value were per generalized linear mixed model, which includes treatment, visit, treatment by visit interaction and baseline age stratification factor as factors, baseline RSS total score as a continuous covariate.|generalized linear mixed model|||||206.3|5.6|0.0002
71066069|NCT02915705|141641511|SUPERIORITY||difference in LS means|1.02|||<|0.0001|TWO_SIDED|95.0|0.72|1.33|||GEE model|||Per generalized estimating equation (GEE) model, which included RGI-C as the dependent variable, treatment, visit, treatment by visit interaction and baseline age stratification factor as factors, baseline RSS score as a continuous covariate, with exchangeable covariate structure.||1.33|0.72|< 0.0001
71066070|NCT02915705|141641512|SUPERIORITY||LS Mean Difference|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.74|-0.94||LS mean, SE, CI, and 2-sided p value per ANCOVA model, which included treatment group and baseline age stratification factor as independent variables and baseline RSS score as a continuous covariate.|ANCOVA|||||-0.94|-1.74|< 0.0001
71066071|NCT02915705|141641513|SUPERIORITY||difference in LS means|-1.21|||<|0.0001|TWO_SIDED|95.0|-1.59|-0.83||LS mean, SE, CI, and 2-sided p value per GEE model, which included treatment, visit, treatment by visit interaction and baseline age stratification factor as factors, baseline RSS score as a continuous covariate.|GEE model|||||-0.83|-1.59|< 0.0001
71066072|NCT02915705|141641514|SUPERIORITY||LS Mean Difference|0.4||||0.0162|TWO_SIDED|95.0|0.07|0.72||LS mean, SE, CI, and 2-sided p value per GEE model, which included treatment, visit, treatment by visit interaction, and baseline age stratification factor as factors; and baseline RSS score as a continuous covariate.|GEE model|||||0.72|0.07|0.0162
71066073|NCT02915705|141641515|SUPERIORITY||difference in LS means|0.97|||<|0.0001|TWO_SIDED|95.0|0.57|1.37||LS mean, SE, CI, and 2-sided p value per GEE model, which included treatment, visit, treatment by visit interaction, and baseline age stratification factor as factors; and baseline RSS score as a continuous covariate.|GEE model|||||1.37|0.57|< 0.0001
71111723|NCT00325130|141729960|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -5%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
71111724|NCT00325130|141729961|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -5%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
71066074|NCT02915705|141641516|SUPERIORITY||LS Mean Difference|0.12||||0.0408|TWO_SIDED|95.0|0.01|0.24|||GEE model|||LS mean, SE, CI, and 2-sided p value per GEE model, which included change from baseline for recumbent length/standing height Z score as the dependent variable, treatment group, visit, interaction between treatment group by visit and baseline RSS stratification as factors, age and baseline recumbent length/standing height Z score as continuous covariates, with exchangeable covariance structure.||0.24|0.01|0.0408
71111725|NCT00325130|141729962|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -5%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
71111726|NCT00325130|141729963|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
71111727|NCT00325130|141729964|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
71111728|NCT00325130|141729965|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
71111729|NCT00325130|141729966|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
71111730|NCT00325130|141729967|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
71111731|NCT00325130|141729968|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
70852706|NCT01578850|141194334|SUPERIORITY_OR_OTHER||Difference in proportions|3.3||||0.258|TWO_SIDED|95.0|-3.57|10.13|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: LDA: Week 24||10.13|-3.57|0.258
71066075|NCT02915705|141641517|SUPERIORITY||difference in LS means|0.14||||0.049|TWO_SIDED|95.0|0.0|0.29|||GEE model|||LS mean, SE, CI, and 2-sided p value per GEE model, which included change from baseline for recumbent length/standing height Z score as the dependent variable, treatment group, visit, interaction between treatment group by visit and baseline RSS stratification as factors, age and baseline recumbent length/standing height Z score as continuous covariates, with exchangeable covariance structure.||0.29|0.00|0.0490
71066076|NCT02915705|141641518|SUPERIORITY||difference in LS means|1.02||||0.0386|TWO_SIDED|95.0|0.06|1.99|||ANCOVA|||LS mean, SE, CI, and 2-sided p value per ANCOVA model, which included change from baseline for growth velocity Z score as the dependent variable, treatment group and baseline RSS total score stratification as factors, baseline Z score and age as continuous covariates.||1.99|0.06|0.0386
71066077|NCT02915705|141641519|SUPERIORITY||difference in LS means|1.12||||0.0047|TWO_SIDED|95.0|0.37|1.88|||ANCOVA|||LS mean, SE, CI, and 2-sided p value per ANCOVA model, which included change from baseline for growth velocity Z score as the dependent variable, treatment group and baseline RSS total score stratification as factors, baseline Z score and age as continuous covariates.||1.88|0.37|0.0047
71066078|NCT02915705|141641520|SUPERIORITY||difference|1.04|||<|0.0001|TWO_SIDED|95.0|0.81|1.27|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 1||1.27|0.81|< 0.0001
71066079|NCT02915705|141641520|SUPERIORITY||difference|1.03|||<|0.0001|TWO_SIDED|95.0|0.79|1.27|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 4||1.27|0.79|< 0.0001
71066080|NCT02915705|141641520|SUPERIORITY||difference|0.78|||<|0.0001|TWO_SIDED|95.0|0.58|0.97|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 8||0.97|0.58|< 0.0001
71066081|NCT02915705|141641520|SUPERIORITY||difference|0.63|||<|0.0001|TWO_SIDED|95.0|0.44|0.81|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 16||0.81|0.44|< 0.0001
71066082|NCT02915705|141641520|SUPERIORITY||difference|0.51|||<|0.0001|TWO_SIDED|95.0|0.3|0.72|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 24||0.72|0.30|< 0.0001
70938346|NCT01159600|141376656|SUPERIORITY_OR_OTHER||Mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.79|-0.48||Each of the hypotheses (10mg vs placebo and 25mg vs. placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c as a linear covariate and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met: empa 25mg minus Met: placebo|Null hypothesis: No difference in change from baseline to week 24 in HbA1c between Empagliflozin 25mg and placebo. The study consisted of two substudies as defined by the two background medications 'metformin' and 'metformin + SU'. Within each group of background medication, each of the two hypotheses (10mg vs placebo and 25mg vs. placebo) was tested in a two-sided test.||-0.48|-0.79|<0.0001
70938347|NCT01159600|141376656|SUPERIORITY_OR_OTHER||Mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.79|-0.49||Each of the hypotheses (10mg vs placebo and 25mg vs. placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c as a linear covariate and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met+SU: empa 10mg minus Met+SU: placebo|Null hypothesis: No difference in change from baseline to week 24 in HbA1c between Empagliflozin 10mg and placebo. The study consisted of two substudies as defined by the two background medications 'metformin' and 'metformin + SU'. Within each group of background medication, each of the two hypotheses (10mg vs placebo and 25mg vs. placebo) was tested in a two-sided test.||-0.49|-0.79|<0.0001
70941781|NCT04748445|141383935|OTHER||Slope|5.075|STANDARD_ERROR_OF_MEAN|1.878||0.0078|TWO_SIDED|90.0|1.964|8.187|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 05 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||8.187|1.964|0.0078
71066083|NCT02915705|141641520|SUPERIORITY||difference|0.7|||<|0.0001|TWO_SIDED|95.0|0.51|0.89|||GEE model|||Week 32||0.89|0.51|< 0.0001
70852707|NCT01578850|141194334|SUPERIORITY_OR_OTHER||Difference in proportions|17.7||||0.005|TWO_SIDED|95.0|7.49|27.92|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: LDA: Week 28||27.92|7.49|0.005
71066084|NCT02915705|141641520|SUPERIORITY||difference|0.71|||<|0.0001|TWO_SIDED|95.0|0.51|0.91|||GEE model||Difference (burosumab - Oral Phosphate/Active Vitamin D)|Week 40||0.91|0.51|< 0.0001
71066085|NCT02915705|141641520|SUPERIORITY||difference|0.61|||<|0.0001|TWO_SIDED|95.0|0.39|0.82|||GEE model|||Week 52||0.82|0.39|< 0.0001
71066086|NCT02915705|141641520|SUPERIORITY||difference|0.69|||<|0.0001|TWO_SIDED|95.0|0.49|0.9|||GEE model|||Week 64||0.90|0.49|< 0.0001
71066087|NCT02915705|141641522|SUPERIORITY||difference in LS means|0.74|||<|0.0001|TWO_SIDED|95.0|0.58|0.91|||ANCOVA||Difference (KRN23 - Oral Phosphate/Active Vitamin D)|||0.91|0.58|< 0.0001
71066088|NCT02915705|141641525|SUPERIORITY||difference|48.27|||<|0.0001|TWO_SIDED|95.0|36.53|60.02|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 1||60.02|36.53|< 0.0001
71066089|NCT02915705|141641525|SUPERIORITY||difference|21.09|||<|0.0001|TWO_SIDED|95.0|12.01|30.16|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 4||30.16|12.01|< 0.0001
71066090|NCT02915705|141641525|SUPERIORITY||difference|15.75||||0.001|TWO_SIDED|95.0|6.35|25.15|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 8||25.15|6.35|0.0010
71066091|NCT02915705|141641525|SUPERIORITY||difference|12.97||||0.0078|TWO_SIDED|95.0|3.41|22.53|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 16||22.53|3.41|0.0078
71066092|NCT02915705|141641525|SUPERIORITY||difference|10.89||||0.0101|TWO_SIDED|95.0|2.59|19.19|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 24||19.19|2.59|0.0101
71066093|NCT02915705|141641525|SUPERIORITY||difference|6.23||||0.1165|TWO_SIDED|95.0|-1.55|14.02|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 32||14.02|-1.55|0.1165
71066094|NCT02915705|141641525|SUPERIORITY||difference|11.21||||0.0317|TWO_SIDED|95.0|0.98|21.44|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 40||21.44|0.98|0.0317
71066095|NCT02915705|141641525|SUPERIORITY||difference|5.01||||0.3044|TWO_SIDED|95.0|-4.55|14.56|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 52||14.56|-4.55|0.3044
71066096|NCT02915705|141641525|SUPERIORITY||difference|8.7||||0.0145|TWO_SIDED|95.0|1.72|15.68|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D|Week 64||15.68|1.72|0.0145
71066097|NCT02915705|141641527|SUPERIORITY||difference|1.65|||<|0.0001|TWO_SIDED|95.0|1.28|2.02|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 4||2.02|1.28|< 0.0001
71066098|NCT02915705|141641527|SUPERIORITY||difference|1.42|||<|0.0001|TWO_SIDED|95.0|1.19|1.64|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 8||1.64|1.19|< 0.0001
71066099|NCT02915705|141641527|SUPERIORITY||difference|1.16|||<|0.0001|TWO_SIDED|95.0|0.84|1.48|||GEE model|||Week 16||1.48|0.84|< 0.0001
71066100|NCT02915705|141641527|SUPERIORITY||difference|1.11|||<|0.0001|TWO_SIDED|95.0|0.8|1.41|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 24||1.41|0.80|< 0.0001
71066101|NCT02915705|141641527|SUPERIORITY||difference|1.24|||<|0.0001|TWO_SIDED|95.0|0.98|1.51|||GEE model|||Week 32||1.51|0.98|< 0.0001
71066102|NCT02915705|141641527|SUPERIORITY||difference|1.35|||<|0.0001|TWO_SIDED|95.0|1.1|1.6|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 40||1.60|1.10|< 0.0001
71066103|NCT02915705|141641527|SUPERIORITY||difference|1.26|||<|0.0001|TWO_SIDED|95.0|0.97|1.54|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 52||1.54|0.97|< 0.0001
71066104|NCT02915705|141641527|SUPERIORITY||difference|1.25|||<|0.0001|TWO_SIDED|95.0|0.96|1.54|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 64||1.54|0.96|< 0.0001
71066105|NCT02915705|141641529|SUPERIORITY||difference|-92.53|||<|0.0001|TWO_SIDED|95.0|-131.4|-53.66|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 16||-53.66|-131.40|< 0.0001
71066106|NCT02915705|141641529|SUPERIORITY||difference|-85.57|||<|0.0001|TWO_SIDED|95.0|-126.37|-44.76|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 24||-44.76|-126.37|< 0.0001
71066107|NCT02915705|141641529|SUPERIORITY||difference|-95.95|||<|0.0001|TWO_SIDED|95.0|-136.05|-55.84|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 40||-55.84|-136.05|< 0.0001
70938348|NCT01159600|141376656|SUPERIORITY_OR_OTHER||Mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.74|-0.44||Each of the hypotheses (10mg vs placebo and 25mg vs. placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c as a linear covariate and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met+SU: empa 25mg minus Met+SU: placebo|Null hypothesis: No difference in change from baseline to week 24 in HbA1c between Empagliflozin 25mg and placebo. The study consisted of two substudies as defined by the two background medications 'metformin' and 'metformin + SU'. Within each group of background medication, each of the two hypotheses (10mg vs placebo and 25mg vs. placebo) was tested in a two-sided test.||-0.44|-0.74|<0.0001
70938349|NCT01301183|141376668|OTHER|ANCOVA||||||0.109||||||Adjusted for baseline age, height, bone density and 12-month weight change|ANCOVA|||||||.109
71066108|NCT02915705|141641529|SUPERIORITY||difference|-111.28|||<|0.0001|TWO_SIDED|95.0|-152.08|-70.49|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 52||-70.49|-152.08|< 0.0001
71066109|NCT02915705|141641529|SUPERIORITY||difference|-146.56|||<|0.0001|TWO_SIDED|95.0|-191.61|-101.52|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 64||-101.52|-191.61|< 0.0001
71066110|NCT02915705|141641532|SUPERIORITY||difference in LS means|-5.02||||0.0212|TWO_SIDED|95.0|-9.29|-0.75|||GEE model|||Pain Interference Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||-0.75|-9.29|0.0212
71066111|NCT02915705|141641532|SUPERIORITY||difference in LS means|2.68||||0.1009|TWO_SIDED|95.0|-0.52|5.89|||GEE model|||Physical Function Mobility Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||5.89|-0.52|0.1009
71066112|NCT02915705|141641532|SUPERIORITY||difference in LS means|-3.25||||0.1676|TWO_SIDED|95.0|-7.86|1.37|||GEE model|||Fatigue Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||1.37|-7.86|0.1676
71066113|NCT02915705|141641533|SUPERIORITY||difference in LS means|-2.26||||0.3091|TWO_SIDED|95.0|-6.61|2.09|||GEE model|||Pain Interference Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||2.09|-6.61|0.3091
71066114|NCT02915705|141641533|SUPERIORITY||difference in LS means|1.9||||0.3145|TWO_SIDED|95.0|-1.8|5.59|||GEE model|||Physical Function Mobility Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||5.59|-1.80|0.3145
71066115|NCT02915705|141641533|SUPERIORITY||difference in LS means|-1.08||||0.681|TWO_SIDED|95.0|-6.21|4.06|||GEE model|||Fatigue Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||4.06|-6.21|0.6810
71066116|NCT02915705|141641534|SUPERIORITY||Difference in LS Means|0.01||||0.9862|TWO_SIDED|95.0|-0.79|0.8|||GEE model|||GEE model includes change from baseline for FPS-R as the dependent variable, treatment group, visit, interaction between treatment group by visit and baseline RSS stratification as factors, baseline FPS-R as a covariate, with exchangeable covariance structure. The LS Mean, SE, 95% CI and 2-sided p-value are from the GEE model.||0.80|-0.79|0.9862
71066117|NCT02915705|141641535|SUPERIORITY||difference in LS means|0.05||||0.8786|TWO_SIDED|95.0|-0.58|0.68|||GEE model|||GEE model includes change from baseline for FPS-R as the dependent variable, treatment group, visit, interaction between treatment group by visit and baseline RSS stratification as factors, baseline FPS-R as a covariate, with exchangeable covariance structure. The LS Mean, SE, 95% CI and 2-sided p-value are from the GEE model.||0.68|-0.58|0.8786
71066118|NCT02915705|141641536|SUPERIORITY||difference in LS means|43.46||||0.0514|TWO_SIDED|95.0|-0.26|87.17|||GEE model|||2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||87.17|-0.26|0.0514
71066119|NCT02915705|141641537|SUPERIORITY||difference in LS means|45.55||||0.0399|TWO_SIDED|95.0|2.09|89.02|||GEE model|||2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||89.02|2.09|0.0399
71111732|NCT00325130|141729969|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.5."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
71066120|NCT02915705|141641538|SUPERIORITY||difference in LS means|6.72||||0.0633|TWO_SIDED|95.0|-0.37|13.82|||GEE model|||2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||13.82|-0.37|0.0633
71066121|NCT02915705|141641539|SUPERIORITY||difference in LS means|7.27||||0.0496|TWO_SIDED|95.0|0.01|14.52|||GEE model|||2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||14.52|0.01|0.0496
71066122|NCT00150488|141641543|OTHER|Compared to baseline|||||<|0.001|||||||Chi-squared|||||||<0.001
71066123|NCT03291431|141641546|OTHER|Chi-Square comparison of frequencies|Pearson Chi-Square|0.17||||0.99|TWO_SIDED|||||A p-value of \<0.05 is considered statistically significant.|Chi-squared|||||||0.99
71066124|NCT03291431|141641547|OTHER||Slope|-0.2||||0.68|TWO_SIDED|95.0||||p \< .05 considered statistically significant.|Mixed Models Analysis||Rate of change compared between groups using linear mixed modeling.|Linear mixed modeling||||0.68
71066125|NCT03291431|141641548|OTHER|||||||0.34||||||p-value \< .05 considered statistically significant.|Mixed Models Analysis|||||||0.34
71066126|NCT03291431|141641549|OTHER|Linear mixed modeling|Slope|-1.99||||0.7|TWO_SIDED|||||p \< .05 considered statistically significant.|Mixed Models Analysis||Rate of change compared between groups using linear mixed modeling.|||||0.70
71066127|NCT03291431|141641550|OTHER||Slope|0.3||||0.11|TWO_SIDED|||||p \< .05 considered statistically significant.|Mixed Models Analysis|||Linear mixed modeling||||0.11
71066128|NCT00550745|141641558|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.26||||||95.0|0.91|1.73|||||Relative risk (ZOSTAVAX™/placebo) of proportion of subjects reporting ≥ 1 serious AE through 42 Days postvaccination and 95% Confidence Interval were based on Miettinen and Nurminen \[Comparative analysis of two rates. Stat Med 1985;4:213-26\] method.|||1.73|0.91|
71066129|NCT00550745|141641559|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.13||||||95.0|0.98|1.32|||||Relative risk (ZOSTAVAX™/placebo) of proportion of subjects reporting ≥ 1 serious AE through 6 months postvaccination and 95% Confidence Interval were based on Miettinen and Nurminen \[Comparative analysis of two rates. Stat Med 1985;4:213-26\] method.|||1.32|0.98|
71066130|NCT03850483|141641569|SUPERIORITY||Least square (LS) mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.65||0.1641|TWO_SIDED|90.0|-1.71|0.43||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||0.43|-1.71|0.1641
71066131|NCT03850483|141641569|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.65||0.61|TWO_SIDED|90.0|-0.89|1.26||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||1.26|-0.89|0.6100
71066132|NCT03850483|141641569|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.65||0.1686|TWO_SIDED|90.0|-1.7|0.45||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||0.45|-1.70|0.1686
71066133|NCT03850483|141641569|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.64||0.1051|TWO_SIDED|90.0|-1.87|0.25||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||0.25|-1.87|0.1051
71066134|NCT03850483|141641569|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.68||0.3583|TWO_SIDED|90.0|-1.37|0.88||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||0.88|-1.37|0.3583
71111733|NCT00325130|141729970|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.5."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
71111734|NCT00325130|141729971|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.5."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
71066135|NCT03850483|141641569|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.66||0.1131|TWO_SIDED|90.0|-1.88|0.29||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||0.29|-1.88|0.1131
71066136|NCT03850483|141641569|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.64||0.1812|TWO_SIDED|90.0|-1.64|0.47||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||0.47|-1.64|0.1812
71066137|NCT03850483|141641570|SUPERIORITY||Risk Difference (RD)|3.4||||0.3747|TWO_SIDED|90.0|-10.6|17.9|||Chan and Zhang method|||||17.9|-10.6|0.3747
71066138|NCT03850483|141641570|SUPERIORITY||Risk Difference (RD)|8.5||||0.243|TWO_SIDED|90.0|-6.6|25.9|||Chan and Zhang method|||||25.9|-6.6|0.2430
71066139|NCT03850483|141641570|SUPERIORITY||Risk Difference (RD)|3.4||||0.3747|TWO_SIDED|90.0|-10.6|17.9|||Chan and Zhang method|||||17.9|-10.6|0.3747
71066140|NCT03850483|141641570|SUPERIORITY||Risk Difference (RD)|14.5||||0.0665|TWO_SIDED|0.0665|-1.3|31.5|||Chan and Zhang method|||||31.5|-1.3|0.0665
71066141|NCT03850483|141641570|SUPERIORITY||Risk Difference (RD)|6.1||||0.3423|TWO_SIDED|90.0|-12.1|25.5|||Chan and Zhang method|||||25.5|-12.1|0.3423
71066142|NCT03850483|141641570|SUPERIORITY||Risk Difference (RD)|12.9||||0.1271|TWO_SIDED|90.0|-4.7|30.9|||Chan and Zhang method|||||30.9|-4.7|0.1271
71066143|NCT03850483|141641570|SUPERIORITY||Risk Difference (RD)|3.2||||0.401|TWO_SIDED|90.0|-13.2|21.1|||Chan and Zhang method|||||21.1|-13.2|0.4010
71066144|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|-0.1||||0.4225|TWO_SIDED|90.0|-11.2|10.4|||Chan and Zhang method|||Week 1||10.4|-11.2|0.4225
71066145|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7483|TWO_SIDED|90.0|-14.0|5.0|||Chan and Zhang method|||Week 1||5.0|-14.0|0.7483
71066146|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7539|TWO_SIDED|90.0|-14.0|4.8|||Chan and Zhang method|||Week 1||4.8|-14.0|0.7539
71066147|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7539|TWO_SIDED|90.0|-14.0|4.8|||Chan and Zhang method|||Week 1||4.8|-14.0|0.7539
70938350|NCT01301183|141376669|OTHER|||||||0.344||||||Adjusted for age, height, baseline trabecular number and change in weight over 12 months|ANCOVA|||||||0.344
71111735|NCT00325130|141729972|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.5."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
71111736|NCT00325130|141729973|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.67."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
71111737|NCT00325130|141729974|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.67."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
71111738|NCT00325130|141729975|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.67."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
71111739|NCT00325130|141729976|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.67."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
71111740|NCT00326001|141729977|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||P-value not adjusted for multiple comparisons|t-test, 2 sided|||||||0.25
70938351|NCT01072149|141376670|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.233|||<|0.001|TWO_SIDED|95.0|0.179|0.287|||Mixed Models Analysis|||||0.287|0.179|<0.001
71111741|NCT00326001|141729978|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||Chi-squared|||||||0.042
71111742|NCT00326001|141729979|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Chi-squared|||||||0.53
71111743|NCT00326001|141729980|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71111744|NCT03046927|141729996|EQUIVALENCE|p values were obtained using generalized linear model with GEE for repeated measures.|Mean Difference (Net)|0.08|||<|0.001|TWO_SIDED||||||generalized linear model with dependent||Trend analysis was performed using generalized linear model with GEE for repeated measures.|||||<0.001
70938352|NCT01072149|141376670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|||<|0.001|TWO_SIDED|95.0|0.165|0.275|||Mixed Models Analysis|||||0.275|0.165|<0.001
71111745|NCT03046927|141729997|OTHER||trend analysis|0.04|||<|0.01|TWO_SIDED|||||The threshold for statistical significance was p=0.05|generalized linear model|p values were obtained using generalized linear model with GEE for repeated measures.|Trend analysis was performed using generalized linear model with GEE for repeated measures.|||||<0.01
71111746|NCT03046927|141729998|OTHER|p values were derived from trend analysis using generalized linear models|Mean Difference (Net)|0.507||||0.0241|TWO_SIDED|95.0|0.066|0.947||The p-value was derived from a statistical model adjusted for age, sex, and BMI|General linear models|||||0.947|0.066|0.0241
71111747|NCT03046927|141729999|OTHER|p values were obtained from a generalized linear model with repeated measures|Mean Difference (Net)|10.37||||0.23|TWO_SIDED|95.0|-6.4|27.13||The p-value was derived from a statistical model adjusted for age, sex, and BMI|Regression, Linear|||||27.13|-6.40|0.23
71111748|NCT03046927|141730000|OTHER||trend analysis|0.02|||<|0.001|TWO_SIDED||||||generalized linear model|p values were obtained using generalized linear model with GEE for repeated measures.|||Trend analysis was obtained using generalized linear model GEE.|||<0.001
71111749|NCT01530178|141730076|OTHER|Non-specified|Mean Difference (Final Values)|-27.91||||0.003|TWO_SIDED|95.0|-44.7|-11.2|||ANOVA|||||-11.2|-44.7|0.003
70852708|NCT01578850|141194334|SUPERIORITY_OR_OTHER||Difference in proportions|27.2|||<|0.001|TWO_SIDED|95.0|16.93|37.55|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: LDA: Week 36||37.55|16.93|<0.001
70938353|NCT01072149|141376670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.236|||<|0.001|TWO_SIDED|95.0|0.181|0.291|||Mixed Models Analysis|||||0.291|0.181|<0.001
70938354|NCT00080119|141376697|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.93|TWO_SIDED|95.0|0.67|1.44||Threshold p-value for significance = 0.0492|Log Rank||Hazard ratio for INH relative to Placebo|||1.44|0.67|0.93
70938355|NCT00080119|141376698|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.43|TWO_SIDED|95.0|0.55|1.3||Threshold p-value for significance = 0.0493|Log Rank||Hazard ratio for INH relative to Placebo|||1.30|0.55|0.43
70938356|NCT00949234|141376724|OTHER||||||<|0.05|||||||Chi-squared|||There was no power calculation for this analysis. The study was mainly descriptive, but Chi-square tests were used to determine if there were differences between individuals who were retained at the 24 Week Follow-up visit from individuals who were not retained at the 24 Week Follow-up visit.||||<0.05
70938357|NCT00988429|141376791|SUPERIORITY_OR_OTHER_LEGACY|||||||0.058||95.0|||||ANCOVA|||||||0.058
71111750|NCT01530178|141730076|OTHER|Non-specified|Mean Difference (Final Values)|-2.131||||0.68|TWO_SIDED|95.0|-12.91|8.652|||ANOVA|||||8.652|-12.91|0.68
71111751|NCT01530178|141730076|OTHER||Mean Difference (Final Values)|-25.78||||0.0005|TWO_SIDED|95.0|-38.39|-13.17|||ANOVA|||||-13.17|-38.39|0.0005
71111752|NCT00293813|141730086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1||||||95.0|2.6|5.7|||ANCOVA|||||5.7|2.6|
71111753|NCT00293813|141730086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||||95.0|-0.6|2.6|||ANCOVA|||||2.6|-.6|
71111754|NCT01139411|141730088|SUPERIORITY_OR_OTHER|||||||0.06||||||Threshold for significance: 0.05|ANCOVA|||"Null hypothesis was that the amount of weight lost by adolescents in Enhanced Parent Involvement and Minimal Parent involvement would not be significantly different. The study was powered at .8 to achieve a medium effect size (f = .26; partial eta sq. = 0.06).~The end-of-treatment BMI value was the dependent variable, with the baseline BMI value entered as a covariate."||||0.06
71111755|NCT01139411|141730089|SUPERIORITY_OR_OTHER|||||||0.58||||||Threshold for significance: 0.05|ANCOVA|||The end-of-treatment value was the dependent variable, with the baseline value entered as a covariate.||||0.58
71111756|NCT01139411|141730090|SUPERIORITY_OR_OTHER|||||||0.19||||||Threshold for significance: 0.05|ANCOVA|||||||0.19
71111757|NCT01139411|141730091|SUPERIORITY_OR_OTHER|||||||0.72||||||Threshold for significance: 0.05|ANCOVA|||||||0.72
71111758|NCT01139411|141730092|SUPERIORITY_OR_OTHER|||||||0.41|||||||ANCOVA|||||||0.41
71111759|NCT01139411|141730093|SUPERIORITY_OR_OTHER|||||||0.01||||||Threshold for significance: 0.05|ANCOVA|||||||0.01
71111760|NCT01139411|141730094|SUPERIORITY_OR_OTHER|||||||0.61||||||Threshold for significance: 0.05|ANCOVA|||||||0.61
71111761|NCT01521923|141730095|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.719|||=|0.112|TWO_SIDED|95.0|0.881|3.354|||Regression, Logistic|||In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in a hierarchical order beginning with the CZP standard maintenance dosing (200 mg Q2W) + MTX group vs the CZP stopped dosing (PBO) + MTX group. If this analysis was statistically significant at the alpha =0.05 level, then an additional comparison of the CZP reduced frequency dosing (200 mg Q4W) + MTX group vs the CZP stopped dosing + MTX group was performed with testing at the alpha =0.05 level||3.354|0.881|=0.112
71111762|NCT01521923|141730095|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.889|||=|0.041|TWO_SIDED|95.0|1.026|3.48|||Regression, Logistic|||In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in a hierarchical order. A hierarchical test procedure was applied to protect the Overall significance level for the multiplicity of endpoints. Hypothesis testing was performed in the following predefined order, each at a 2-sided 95 % alpha level||3.480|1.026|=0.041
71111763|NCT00460655|141730162|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.428||||0.006||95.0|-5.841|-1.016|||t-test, 2 sided|||||-1.016|-5.841|0.006
71111764|NCT01484496|141730198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.0006|TWO_SIDED|95.0|1.25|2.25|||Regression, Logistic|||||2.25|1.25|0.0006
70938358|NCT00988429|141376791|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0|||||ANCOVA|||||||0.004
71111765|NCT01484496|141730199|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.51||||0.0004|TWO_SIDED|95.0|0.35|0.74|||Cox proportional hazards model|||||0.74|0.35|0.0004
71111766|NCT01484496|141730200|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.0732|TWO_SIDED|95.0|0.95|2.84|||Regression, Logistic|||||2.84|0.95|0.0732
71111767|NCT04830215|141730205|OTHER||||||<|0.0001||||||MMRM included fixed effect terms for visit, baseline value, an interaction term of baseline value by visit, and trial center.|MMRM|||||||<0.0001
71111768|NCT04830215|141730206|OTHER||||||<|0.0001||||||MMRM included fixed effect terms for visit, baseline value, an interaction term of baseline value by visit, and trial center.|MMRM|||||||<0.0001
71111769|NCT03994211|141730221|OTHER||Geometric Mean Ratio Estimate|0.94|||||TWO_SIDED|90.0|0.83|1.06||||||||1.06|0.83|
71111770|NCT03994211|141730222|OTHER||Geometric Mean Ratio|1.05|||||TWO_SIDED|90.0|0.95|1.15||||||||1.15|0.95|
71111771|NCT03994211|141730223|OTHER||Geometric Mean Ratio|0.62|||||TWO_SIDED|90.0|0.54|0.7||||||||0.70|0.54|
71111772|NCT03994211|141730224|OTHER||Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.91|1.09||||||||1.09|0.91|
70938359|NCT00988429|141376792|SUPERIORITY_OR_OTHER_LEGACY|||||||0.068|||||||ANCOVA|||||||0.068
70938360|NCT00988429|141376792|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
70938361|NCT01074229|141376793|SUPERIORITY_OR_OTHER|||||||0.05|||||||Kruskal-Wallis|Using Dunns test with Bonferroni conrrection for individual comparisons.||||||.05
71111773|NCT03994211|141730225|OTHER||Geometric Mean Ratio|0.57|||||TWO_SIDED|90.0|0.48|0.69||||||||0.69|0.48|
71111774|NCT03994211|141730226|OTHER||Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.9|1.09||||||||1.09|0.90|
71111775|NCT04677543|141730267|SUPERIORITY||Percentage Difference|10.4||||0.2819|TWO_SIDED|95.0|-8.6|29.5|||Standardized Logistic Regression||The percentage difference and confidence intervals are estimated by standardized logistic regression with treatment group and history of MAC lung infection as factors in the model.|||29.5|-8.6|0.2819
71111776|NCT04677543|141730268|SUPERIORITY||Percentage Difference|6.1||||0.508|TWO_SIDED|95.0|-11.9|24.1|||Standardized Logistic Regression||The percentage difference and confidence intervals are estimated by standardized logistic regression with treatment group and history of MAC lung infection as factors in the model.|||24.1|-11.9|0.5080
71111777|NCT04677543|141730269|SUPERIORITY||Percentage Difference|16.7||||0.0712|TWO_SIDED|95.0|-1.4|34.9|||Standardized Logistic Regression|||||34.9|-1.4|0.0712
71111778|NCT04677543|141730270|SUPERIORITY||Least Square Mean Difference|4.48||||0.1073|TWO_SIDED|95.0|-0.97|9.93|||ANCOVA|||||9.93|-0.97|0.1073
71111779|NCT04677543|141730271|SUPERIORITY||Least Square Mean Difference|-0.4||||0.613|TWO_SIDED|95.0|-2.2|1.3|||ANCOVA|||||1.3|-2.2|0.6130
71111780|NCT04677543|141730272|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.3542|TWO_SIDED|95.0|0.79|1.92|||Regression, Cox||A Cox regression model was applied to calculate the hazard ratio. The model included effects for treatment and history of MAC lung infection (initial or subsequent).|||1.92|0.79|0.3542
71111781|NCT04677543|141730273|SUPERIORITY||Hazard Ratio (HR)|1.35||||0.1583|TWO_SIDED|95.0|0.89|2.06|||Regression, Cox||A Cox regression model was applied to calculate the hazard ratio. The model included effects for treatment and history of MAC lung infection (initial or subsequent).|||2.06|0.89|0.1583
71111782|NCT02110485|141730281|SUPERIORITY|||||||0.03|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
71111783|NCT02110485|141730282|OTHER|||||||0.27|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.27
71111784|NCT02110485|141730283|OTHER|||||||0.67|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.67
71111785|NCT02110485|141730284|OTHER|||||||0.17|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.17
71111786|NCT02110485|141730285|OTHER|||||||0.84|||||||Fisher Exact|||||||.84
71111787|NCT02110485|141730286|OTHER|||||||0.99|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.99
70938362|NCT01074229|141376793|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|28.0||||0.05|TWO_SIDED|95.0|9.0|37.0|||Dunns test|Bonferonni correction||||37|9|.05
70938363|NCT01074229|141376793|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.0||||0.05|TWO_SIDED|95.0|14.0|42.0|||Dunns Test|Bonferroni correction||||42|14|.05
70938364|NCT01074229|141376794|SUPERIORITY_OR_OTHER|||||||0.05|||||||Kruskal-Wallis|With Dunns test and Bonferonni correction.||||||.05
70938365|NCT01074229|141376794|SUPERIORITY_OR_OTHER||Median Difference (Net)|10.0||||0.003|TWO_SIDED|95.0|3.0|15.0|||Dunns test|||||15|3|0.003
70938366|NCT01074229|141376794|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0||||0.14|TWO_SIDED|95.0|-1.0|12.0|||Dunns test|||||12|-1|0.14
71066148|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-6.4|8.9|||Chan and Zhang method|||Week 1||8.9|-6.4|0.5000
71066149|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|2.9||||0.2125|TWO_SIDED|90.0|-3.4|13.2|||Chan and Zhang method|||Week 1||13.2|-3.4|0.2125
71066150|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|2.7||||0.2267|TWO_SIDED|90.0|-3.5|12.2|||Chan and Zhang method|||Week 1||12.2|-3.5|0.2267
71066151|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7592|TWO_SIDED|90.0|-14.0|4.6|||Chan and Zhang method|||Week 2||4.6|-14.0|0.7592
71066152|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7299|TWO_SIDED|90.0|-14.0|5.5|||Chan and Zhang method|||Week 2||5.5|-14.0|0.7299
70938367|NCT02823574|141376805|SUPERIORITY||Odds Ratio (OR)|0.68||||0.2897|TWO_SIDED|95.5|0.33|1.43|||Mantel Haenszel|||Treatment A over Treatment B||1.43|0.33|0.2897
70938368|NCT02823574|141376810|SUPERIORITY||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.78|1.41|||||computed using a cox proportional hazard model stratified by randomization PD-L1 and HPV status|||1.41|0.78|
70938369|NCT02823574|141376811|SUPERIORITY||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.78|1.41|||||computed using a cox proportional hazard model stratified by randomization PDL-1 and HPV status|||1.41|0.78|
70938370|NCT02823574|141376812|SUPERIORITY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.87|1.36|||||computed using a cox proportional hazard model stratified by randomization PDL-1 and HPV status|||1.36|0.87|
70938371|NCT02823574|141376813|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.81|1.45|||||computed using a cox proportional hazard model stratified by randomization PDL-1 and HPV status|||1.45|0.81|
71066153|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|-0.3||||0.4463|TWO_SIDED|90.0|-11.3|9.4|||Chan and Zhang method|||Week 2||9.4|-11.3|0.4463
71066154|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7539|TWO_SIDED|90.0|-14.0|4.8|||Chan and Zhang method|||Week 2||4.8|-14.0|0.7539
70938372|NCT02823574|141376814|SUPERIORITY||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.81|1.61|||||computed using a cox proportional hazard model stratified by randomization PDL-1 and HPV status|||1.61|0.81|
70938373|NCT02823574|141376839|SUPERIORITY||Odds Ratio (OR)|0.64|||||TWO_SIDED|95.0|0.32|1.29|||Mantel Haenszel|||Treatment A over Treatment B||1.29|0.32|
70938374|NCT03845517|141376859|SUPERIORITY||Risk Difference (RD)|-7.5||||0.8076|TWO_SIDED|95.0|-24.5|9.5||One sided p-value.|Cochran-Mantel-Haenszel|||||9.5|-24.5|0.8076
70938375|NCT03845517|141376859|SUPERIORITY||Risk Difference (RD)|5.2||||0.2189|TWO_SIDED|95.0|-7.9|18.3||One sided p-value.|Cochran-Mantel-Haenszel|||||18.3|-7.9|0.2189
70938376|NCT03845517|141376859|SUPERIORITY||Risk Difference (RD)|1.7||||0.401|TWO_SIDED|95.0|-11.8|15.3||One sided p-value.|Cochran-Mantel-Haenszel|||||15.3|-11.8|0.4010
70938377|NCT03845517|141376860|SUPERIORITY||Risk Difference (RD)|-2.1||||0.595|TWO_SIDED|95.0|-19.1|14.9||One sided p-value.|Cochran-Mantel-Haenszel|||||14.9|-19.1|0.5950
70938378|NCT03845517|141376860|SUPERIORITY||Risk Difference (RD)|8.6||||0.1125|TWO_SIDED|95.0|-5.3|22.6||One sided p-value.|Cochran-Mantel-Haenszel|||||22.6|-5.3|0.1125
70938379|NCT03845517|141376860|SUPERIORITY||Risk Difference (RD)|9.6||||0.0891|TWO_SIDED|95.0|-4.4|23.6||One sided p-value.|Cochran-Mantel-Haenszel|||||23.6|-4.4|0.0891
70938380|NCT01494467|141376881|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
70938381|NCT01494467|141376882|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-8.22|||<|0.001|TWO_SIDED|95.0|-10.18|-6.25|||ANCOVA|||||-6.25|-10.18|<0.001
70938382|NCT01494467|141376883|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
70938383|NCT00257309|141376921|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.21|TWO_SIDED|95.0|0.38|1.23||Unadjusted analysis|Chi-squared|||||1.23|0.38|0.21
71066155|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|-2.2||||0.7009|TWO_SIDED|90.0|-10.1|5.9|||Chan and Zhang method|||Week 2||5.9|-10.1|0.7009
71066156|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|4.0||||0.2507|TWO_SIDED|90.0|-4.5|15.6|||Chan and Zhang method|||Week 2||15.6|-4.5|0.2507
71066157|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|3.5||||0.2993|TWO_SIDED|90.0|-4.8|14.3|||Chan and Zhang method|||Week 2||14.3|-4.8|0.2993
71066158|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7363|TWO_SIDED|90.0|-14.0|5.5|||Chan and Zhang method|||Week 4||5.5|-14.0|0.7363
71066159|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|0.4||||0.5369|TWO_SIDED|90.0|-10.5|12.3|||Chan and Zhang method|||Week 4||12.3|-10.5|0.5369
71066160|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7483|TWO_SIDED|90.0|-14.0|5.0|||Chan and Zhang method|||Week 4||5.0|-14.0|0.7483
71066161|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7483|TWO_SIDED|90.0|-14.0|5.0|||Chan and Zhang method|||Week 4||5.0|-14.0|0.7483
71066162|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|-2.2||||0.599|TWO_SIDED|90.0|-13.7|11.6|||Chan and Zhang method|||Week 4||11.6|-13.7|0.5990
71066163|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|-5.9||||0.7926|TWO_SIDED|90.0|-16.4|4.9|||Chan and Zhang method|||Week 4||4.9|-16.4|0.7926
71066164|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|3.2||||0.3402|TWO_SIDED|90.0|-9.0|17.6|||Chan and Zhang method|||Week 4||17.6|-9.0|0.3402
71066165|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|-3.2||||0.7364|TWO_SIDED|90.0|-14.4|5.7|||Chan and Zhang method|||Week 6||5.7|-14.4|0.7364
71066166|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|4.2||||0.3009|TWO_SIDED|90.0|-7.4|17.7|||Chan and Zhang method|||Week 6||17.7|-7.4|0.3009
71066167|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|3.2||||0.34|TWO_SIDED|90.0|-8.1|15.9|||Chan and Zhang method|||Week 6||15.9|-8.1|0.3400
70938384|NCT02009332|141376922|OTHER||maximum deliverable dose (MDD)|400.0|||||TWO_SIDED||||||||Maximum deliverable dose (MDD) was not reached in the Phase 1 study as no DLTs were observed in any of the dose groups up to ABI-009 400 mg/week.|||||
71111788|NCT00995436|141730287|NON_INFERIORITY_OR_EQUIVALENCE|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.|Mean Difference (Final Values)|-0.58|||||TWO_SIDED|95.0|-1.53|0.36|||||Maxillary right molar|||0.36|-1.53|
71111789|NCT00995436|141730287|NON_INFERIORITY_OR_EQUIVALENCE|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.|Mean Difference (Final Values)|-0.96|||||TWO_SIDED|95.0|-1.89|-0.04|||||Maxillary left molar|||-0.04|-1.89|
71111790|NCT00995436|141730287|NON_INFERIORITY_OR_EQUIVALENCE|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.|Mean Difference (Final Values)|0.62|||||TWO_SIDED|95.0|-0.32|1.55|||||Maxillary right molar|||1.55|-0.32|
70938385|NCT04739306|141376930|EQUIVALENCE|Predefined equivalence margin: -3 letters to +3 letters|Estimated difference in LS means|0.58|||||TWO_SIDED|90.0|-0.52|1.67|||ANCOVA|Analysis conducted for study eye. Primary endpoint as the dependent variable, treatment as a factor, baseline BCVA and country as covariates.||||1.67|-0.52|
70938386|NCT03386344|141376935|SUPERIORITY||Difference in Least Squares (LS) Means|-0.45|STANDARD_ERROR_OF_MEAN|0.102|<|0.0001|TWO_SIDED|95.0|-0.649|-0.25|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline HbA1c as a covariate.||-0.250|-0.649|<0.0001
71066168|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|7.1||||0.1631|TWO_SIDED|90.0|-4.8|21.1|||Chan and Zhang method|||Week 6||21.1|-4.8|0.1631
71066169|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|-3.2||||0.6214|TWO_SIDED|90.0|-17.8|13.0|||Chan and Zhang method|||Week 6||13.0|-17.8|0.6214
71066170|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|-3.2||||0.6214|TWO_SIDED|90.0|-17.8|13.0|||Chan and Zhang method|||Week 6||13.0|-17.8|0.6214
71066171|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|-3.5||||0.6413|TWO_SIDED|90.0|-17.9|11.7|||Chan and Zhang method|||Week 6||11.7|-17.9|0.6413
71066172|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-13.1|13.1|||Chan and Zhang method|||Week 8||13.1|-13.1|0.5000
71111791|NCT00995436|141730287|NON_INFERIORITY_OR_EQUIVALENCE|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.|Mean Difference (Final Values)|-0.09|||||TWO_SIDED|95.0|-1.0|0.83|||||Maxillary left molar|||0.83|-1|
71111792|NCT00995436|141730287|NON_INFERIORITY_OR_EQUIVALENCE|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.||||||0.05||||||Maxillary right molar. F(2, 67) = 3.10. Overall effect of treatment.|ANCOVA|||||||0.05
71111793|NCT00995436|141730287|NON_INFERIORITY_OR_EQUIVALENCE|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.||||||0.08||||||Overall effect of treatment F(2,67) = 2.58.|ANCOVA|||Maxillary left molar.||||0.08
71111794|NCT03674970|141730294|OTHER|||||||0.55|||||||ANOVA|||||||.55
71111795|NCT03674970|141730295|OTHER|||||||0.2146|||||||ANOVA|||||||.2146
70938387|NCT03386344|141376935|SUPERIORITY||Difference in LS Means|-0.43|STANDARD_ERROR_OF_MEAN|0.102|<|0.0001|TWO_SIDED|95.0|-0.634|-0.235|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline HbA1c as a covariate.||-0.235|-0.634|<0.0001
70938388|NCT03386344|141376936|SUPERIORITY||Difference in LS Means|-0.24|STANDARD_ERROR_OF_MEAN|0.423||0.5707|TWO_SIDED|95.0|-1.07|0.59|||ANCOVA|||Percent change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline BMD as a covariate.||0.590|-1.070|0.5707
71066173|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|0.7||||0.5134|TWO_SIDED|90.0|-12.6|15.2|||Chan and Zhang method|||Week 8||15.2|-12.6|0.5134
71066174|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|-0.2||||0.4468|TWO_SIDED|90.0|-13.4|12.5|||Chan and Zhang method|||Week 8||12.5|-13.4|0.4468
71066175|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|7.6||||0.2778|TWO_SIDED|90.0|-6.8|23.9|||Chan and Zhang method|||Week 8||23.9|-6.8|0.2778
71066176|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|2.1||||0.4571|TWO_SIDED|90.0|-14.5|21.0|||Chan and Zhang method|||Week 8||21.0|-14.5|0.4571
71066177|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|-0.1||||0.4741|TWO_SIDED|90.0|-15.3|16.7|||Chan and Zhang method|||Week 8||16.7|-15.3|0.4741
71066178|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|0.4||||0.5153|TWO_SIDED|90.0|-14.8|16.7|||Chan and Zhang method|||Week 8||16.7|-14.8|0.5153
71066179|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|-7.0||||0.8287|TWO_SIDED|90.0|-21.1|5.3|||Chan and Zhang method|||Week 10||5.3|-21.1|0.8287
71066180|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|-2.3||||0.5675|TWO_SIDED|90.0|-17.8|14.2|||Chan and Zhang method|||Week 10||14.2|-17.8|0.5675
71066181|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|6.9||||0.2648|TWO_SIDED|90.0|-9.8|23.2|||Chan and Zhang method|||Week 10||23.2|-9.8|0.2648
71066182|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|3.9||||0.3792|TWO_SIDED|90.0|-11.8|20.8|||Chan and Zhang method|||Week 10||20.8|-11.8|0.3792
71111796|NCT03674970|141730296|OTHER|||||||0.5642|||||||ANOVA|||||||.5642
71111797|NCT03674970|141730297|OTHER|||||||0.4353|||||||ANOVA|||||||.4353
71111798|NCT03674970|141730298|OTHER|||||||0.0348|||||||ANOVA|||||||.0348
71111799|NCT03674970|141730299|OTHER|||||||0.404|||||||ANOVA|||||||.4040
71111800|NCT03299244|141730300|NON_INFERIORITY|Etelcalcetide was considered non-inferior if the upper bound of the two-sided 95% confidence interval of the treatment difference (Cinacalcet - Etelcalcetide) was smaller than 12%, or if the lower bound of (Etelcalcetide - Cinacalcet) greater than -12%. If this criterion was met, the 2 key secondary endpoints were tested sequentially. If both key secondary endpoints were statistically significant, the other secondary endpoints were to be formally tested at an overall significance level of 0.05.|Treatment Difference|4.52|||||TWO_SIDED|95.0|-3.05|12.09|||||Treatment difference (Etelcalcetide - Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region.|"The analysis was conducted on the full analysis set (637 participants). Imputation under the non-inferiority null method was applied to participants who did not have PTH data during the EAP.~The Mantel-Haenszel estimator was used to calculate the treatment (Cinacalcet - Etelcalcetide), stratified by screening PTH level (\< 900 pg/mL, ≥ 900 pg/mL), screening serum cCa (\< 9.0 mg/dL, ≥ 9.0 mg/dL) measured by the central laboratory, and country (China versus non-China)."||12.09|-3.05|
71111801|NCT03299244|141730301|SUPERIORITY|Testing of this key secondary efficacy endpoint at an overall significance level of 0.05 was to be performed if non-inferiority was demonstrated for the primary endpoint.|Odds Ratio (OR)|2.02|||<|0.001|TWO_SIDED|95.0|1.47|2.77|||Cochran-Mantel-Haenszel|CMH test stratified by screening iPTH level, screening cCa level, and country/region.|Odds ratio (Etelcalcetide : Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region.|||2.77|1.47|<0.001
71111802|NCT03299244|141730302|SUPERIORITY|Testing of this key secondary efficacy endpoint at an overall significance level of 0.05 was to be performed if non-inferiority was demonstrated for the primary endpoint, and superiority was demonstrated for the previous key secondary endpoint.|Odds Ratio (OR)|1.42||||0.033|TWO_SIDED|95.0|1.03|1.96|||Cochran-Mantel-Haenszel|CMH test stratified by screening iPTH level, screening cCa level, and country/region.|Odds ratio (Etelcalcetide : Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region.|||1.96|1.03|0.033
71111803|NCT03299244|141730303|SUPERIORITY||Difference in Least Squares Means|-2.82|STANDARD_ERROR_OF_MEAN|0.67|<|0.001|TWO_SIDED|95.0|-4.14|-1.5|||Mixed-effects Model Repeated Measures|Model includes treatment group, randomization stratification factors, study week, and study week by treatment as covariates.|Treatment difference (Etelcalcetide - Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region. Standard error of the mean is the standard error of the least squares means difference.|||-1.50|-4.14|<0.001
71111804|NCT03299244|141730304|SUPERIORITY||Odds Ratio (OR)|1.16||||0.41|TWO_SIDED|95.0|0.82|1.65|||Cochran-Mantel-Haenszel|CMH test stratified by screening iPTH level, screening cCa level, and country/region.|Odds ratio (Etelcalcetide : Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region.|||1.65|0.82|0.41
71111805|NCT02227810|141730337|OTHER|||||||0.652|||||||t-test, 2 sided|||||||0.652
71111806|NCT02227810|141730337|SUPERIORITY|||||||0.123|||||||t-test, 2 sided|||||||0.123
71111807|NCT02227810|141730338|SUPERIORITY|||||||0.051|||||||t-test, 2 sided|||||||0.051
71111808|NCT02227810|141730338|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71111809|NCT02227810|141730339|SUPERIORITY_OR_OTHER|||||||0.051|||||||t-test, 2 sided|||||||0.051
70938389|NCT03386344|141376936|SUPERIORITY||Difference in LS Means|-0.15|STANDARD_ERROR_OF_MEAN|0.419||0.7247|TWO_SIDED|95.0|-0.969|0.674|||ANCOVA|||Percent change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline BMD as a covariate.||0.674|-0.969|0.7247
71111810|NCT02227810|141730340|SUPERIORITY_OR_OTHER|||||||0.792|||||||t-test, 2 sided|||||||0.792
71111811|NCT03063606|141730345|SUPERIORITY|Analyses used all available data. Analyses to compare treatments were all intent-to-treat.||||||0.0002|||||||Mixed Models Analysis|Analyses were performed for all randomized patients who attended the first treatment session.||||||.0002
71111812|NCT03063606|141730346|SUPERIORITY|||||||0.83||||||Analyses used all available data. Analyses to compare treatments were all intent-to-treat.|Mixed Models Analysis|Analyses were performed for all randomized patients who attended the first treatment session.||||||.83
71111813|NCT03079531|141730351|OTHER|||||||0.01|||||||Wilcoxon signed rank test|||The null hypothesis is that there would be no difference in papule/pustule count at baseline and after 16 weeks of secukinumab; the alternative hypothesis is that there would be a difference. Using an alpha=0.05 and power=0.80 (two sided test), the sample size needed would be 20. Assuming a dropout rate of 20%, 24 patients would be needed to achieve sufficient sample size.||||0.01
71111814|NCT03079531|141730352|OTHER|||||||0.02|||||||Wilcoxon signed rank test|||||||0.02
71111815|NCT03079531|141730353|OTHER|||||||0.03|||||||Wilcoxon signed rank test|||||||0.03
71111816|NCT03079531|141730354|OTHER|||||||0.2|||||||Wilcoxon signed rank test|||||||0.2
71111817|NCT03079531|141730355|OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
71111818|NCT03079531|141730357|OTHER|||||||0.56|||||||Wilcoxon signed rank test|||||||0.56
71111819|NCT03265145|141730380|OTHER||Hazard Ratio (HR)|1.23|||||TWO_SIDED|95.0|0.87|1.72|||||"Cox proportional hazards model with baseline ICS prior use as a covariate was used to estimate the hazard ratio (HR) and the two-sided 95% Wald confidence interval (CI).~Ratio: Stiolto Respimat/triple therapy."|||1.72|0.87|
71111820|NCT03265145|141730381|OTHER||adjusted annual rate ratio|1.41|||||TWO_SIDED|95.0|0.97|2.04|||||Ratio: Stiolto Respimat/triple therapy|||2.04|0.97|
71111821|NCT03265145|141730382|OTHER||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.62|2.0|||||"Cox proportional hazards model with baseline ICS prior use as a covariate was used to estimate the hazard ratio (HR) and the two-sided 95% Wald confidence interval (CI).~Ratio: Stiolto Respimat/triple therapy."|||2.00|0.62|
71111822|NCT03265145|141730383|OTHER||adjusted annual rate ratio|1.08|||||TWO_SIDED|95.0|0.58|2.01|||||Ratio: Stiolto Respimat/triple therapy|||2.01|0.58|
71111823|NCT03265145|141730384|OTHER||Risk Ratio (RR)|1.21|||||TWO_SIDED|95.0|0.89|1.64|||||Ratio: Stiolto Respimat/triple therapy|A Cochran-Mantel-Haenszel (CMH) model with baseline ICS prior use as stratum was used to estimate the Risk Ratio (RR) (Stiolto Respimat versus triple therapy) of moderate or severe COPD exacerbations along with 95% CI.||1.64|0.89|
71111824|NCT03265145|141730384|OTHER||Risk Difference (RD)|0.036|||||TWO_SIDED|95.0|-0.022|0.094|||||Ratio: Stiolto Respimat/triple therapy|A Cochran-Mantel-Haenszel (CMH) model with baseline ICS prior use as stratum was used to estimate the Risk Difference (Stiolto Respimat versus triple therapy) of moderate or severe COPD exacerbations along with 95% CI.||0.094|-0.022|
71111825|NCT03159468|141730385|OTHER|||||||0.041||||||This p-value is for the main effect of beverage condition.|ANOVA|||||||.041
71111826|NCT03159468|141730385|OTHER|||||||0.16||||||This p-value is for the main effect of intervention condition.|ANOVA|||||||.160
71111827|NCT03159468|141730385|OTHER|||||||0.462||||||This p-value is for the beverage condition by intervention condition interaction.|ANOVA|||||||.462
71111828|NCT00802997|141730386|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||t-test, 2 sided|||||||0.035
71111829|NCT01848977|141730450|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||Unpaired t-test was used to compare the difference between SrO2 and StO2.||||<0.05
71111830|NCT02522429|141730547|OTHER|||||||0.05||||||Statistic adjusted at familywise level alpha of 0.05 with a Gaussian Random Field Cluster Correction (Z \> 2.7)|t-test, 1 sided|||||||0.05
71111831|NCT02522429|141730548|OTHER||||||<|0.05||||||Statistic adjusted at familywise level alpha of 0.05 with a Gaussian Random Field Cluster Correction (Z \> 2.7). All significant voxels have an associated p-value smaller-or-equal to 0.05 (corrected for multiplicity).|t-test, 1 sided|||||||<0.05
71111832|NCT02522429|141730550|OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Maximum CRS-R prior to LIFUP compared to Maximum CRS-R after LIFUP||||<0.05
71111833|NCT00500357|141730554|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.28|0.56|||||Confidence Intervals (CI) for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 minus \[-\] Vax 1).|Serotype 1: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.56|0.28|
71111834|NCT00500357|141730554|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.67|1.01|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 3: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||1.01|0.67|
71111835|NCT00500357|141730554|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.44|0.72|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 4: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.72|0.44|
71111836|NCT00500357|141730554|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.32|0.53|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 5: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.53|0.32|
71111837|NCT00500357|141730554|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.45|0.91|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 6A: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.91|0.45|
71111838|NCT00500357|141730554|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.56|1.01|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 6B: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||1.01|0.56|
71111839|NCT00500357|141730554|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.25|0.65|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 7F: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.65|0.25|
71111840|NCT00500357|141730554|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.16|0.4|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 9V: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.40|0.16|
71111841|NCT00500357|141730554|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.4|0.78|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 14: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.78|0.40|
70938390|NCT03386344|141376937|SUPERIORITY||Difference in LS Means|0.14|STANDARD_ERROR_OF_MEAN|0.308||0.6454|TWO_SIDED|95.0|-0.462|0.745|||ANCOVA|||Percent change from baseline to Week 26 was analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline lumbar spine as a covariate.||0.745|-0.462|0.6454
70938391|NCT03386344|141376937|SUPERIORITY||Difference in LS Means|0.19|STANDARD_ERROR_OF_MEAN|0.308||0.5289|TWO_SIDED|95.0|-0.41|0.798|||ANCOVA|||Percent change from baseline to Week 26 was analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline lumbar spine as a covariate.||0.798|-0.410|0.5289
71066183|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|2.7||||0.4438|TWO_SIDED|90.0|-16.3|23.1|||Chan and Zhang method|||Week 10||23.1|-16.3|0.4438
71066184|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|-7.5||||0.7014|TWO_SIDED|90.0|-23.3|9.4|||Chan and Zhang method|||Week 10||9.4|-23.3|0.7014
71066185|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|-2.8||||0.5841|TWO_SIDED|90.0|-19.7|15.0|||Chan and Zhang method|||Week 10||15.0|-19.7|0.5841
71066186|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-15.3|15.3|||Chan and Zhang method|||Week 12||15.3|-15.3|0.5000
71066187|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|-2.7||||0.5834|TWO_SIDED|90.0|-17.5|12.3|||Chan and Zhang method|||Week 12||12.3|-17.5|0.5834
71066188|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|10.3||||0.1534|TWO_SIDED|90.0|-6.4|27.2|||Chan and Zhang method|||Week 12||27.2|-6.4|0.1534
71066189|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|7.5||||0.272|TWO_SIDED|90.0|-8.8|24.9|||Chan and Zhang method|||Week 12||24.9|-8.8|0.2720
71066190|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|-8.1||||0.6815|TWO_SIDED|90.0|-25.1|10.4|||Chan and Zhang method|||Week 12||10.4|-25.1|0.6815
71066191|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|3.5||||0.39|TWO_SIDED|90.0|-14.4|22.0|||Chan and Zhang method|||Week 12||22.0|-14.4|0.3900
71066192|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|-2.7||||0.5865|TWO_SIDED|90.0|-20.0|15.9|||Chan and Zhang method|||Week 12||15.9|-20.0|0.5865
71066193|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|4.2||||0.3087|TWO_SIDED|90.0|-8.2|18.9|||Chan and Zhang method|||Week 14||18.9|-8.2|0.3087
71111842|NCT00500357|141730554|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.4|0.65|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 18C: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.65|0.40|
71066194|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|5.2||||0.3137|TWO_SIDED|90.0|-8.2|20.9|||Chan and Zhang method|||Week 14||20.9|-8.2|0.3137
71066195|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|18.0||||0.0245|TWO_SIDED|90.0|2.7|34.8|||Chan and Zhang method|||Week 14||34.8|2.7|0.0245
71066196|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|10.8||||0.1119|TWO_SIDED|90.0|-3.0|26.0|||Chan and Zhang method|||Week 14||26.0|-3.0|0.1119
71066197|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|2.7||||0.414|TWO_SIDED|90.0|-13.2|20.4|||Chan and Zhang method|||Week 14||20.4|-13.2|0.4140
71066198|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|9.7||||0.2356|TWO_SIDED|90.0|-7.2|28.5|||Chan and Zhang method|||Week 14||28.5|-7.2|0.2356
71066199|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|4.5||||0.3638|TWO_SIDED|90.0|-11.5|21.5|||Chan and Zhang method|||Week 14||21.5|-11.5|0.3638
71066200|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|7.7||||0.1613|TWO_SIDED|90.0|-5.2|22.9|||Chan and Zhang method|||Week 16||22.9|-5.2|0.1613
71066201|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|13.9||||0.0557|TWO_SIDED|90.0|-0.5|31.4|||Chan and Zhang method|||Week 16||31.4|-0.5|0.0557
71066202|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|21.6||||0.0114|TWO_SIDED|90.0|5.6|38.3|||Chan and Zhang method|||Week 16||38.3|5.6|0.0114
71066203|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|11.9||||0.0753|TWO_SIDED|90.0|-1.8|28.1|||Chan and Zhang method|||Week 16||28.1|-1.8|0.0753
71066204|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|-3.1||||0.5635|TWO_SIDED|90.0|-20.1|15.2|||Chan and Zhang method|||Week 16||15.2|-20.1|0.5635
71066205|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|-3.6||||0.6201|TWO_SIDED|90.0|-20.3|14.5|||Chan and Zhang method|||Week 16||14.5|-20.3|0.6201
71066206|NCT03850483|141641571|SUPERIORITY||Risk Difference (RD)|-0.7||||0.4792|TWO_SIDED|90.0|-17.6|17.0|||Chan and Zhang method|||Week 16||17.0|-17.6|0.4792
71066207|NCT03850483|141641572|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.31||0.8038|TWO_SIDED|90.0|-0.25|0.79|||MMRM|||Week 1: Mixed-effect model with repeated measures (MMRM) analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.79|-0.25|0.8038
71066208|NCT03850483|141641572|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.31||0.8267|TWO_SIDED|90.0|-0.22|0.81|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.81|-0.22|0.8267
71066209|NCT03850483|141641572|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.31||0.6039|TWO_SIDED|90.0|-0.43|0.6|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.60|-0.43|0.6039
71066210|NCT03850483|141641572|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.31||0.6339|TWO_SIDED|90.0|-0.41|0.62|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.62|-0.41|0.6339
71066211|NCT03850483|141641572|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.2666|TWO_SIDED|90.0|-0.68|0.31|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.31|-0.68|0.2666
71066212|NCT03850483|141641572|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.29||0.2257|TWO_SIDED|90.0|-0.7|0.26|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.26|-0.70|0.2257
71066213|NCT03850483|141641572|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.29||0.1306|TWO_SIDED|90.0|-0.81|0.15|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.15|-0.81|0.1306
71066214|NCT03850483|141641572|SUPERIORITY||LS mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.37||0.9704|TWO_SIDED|90.0|0.09|1.31|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.31|0.09|0.9704
71066215|NCT03850483|141641572|SUPERIORITY||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.38||0.889|TWO_SIDED|90.0|-0.16|1.09|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.09|-0.16|0.8890
71066216|NCT03850483|141641572|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.37||0.4506|TWO_SIDED|90.0|-0.66|0.57|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.57|-0.66|0.4506
71066217|NCT03850483|141641572|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.37||0.584|TWO_SIDED|90.0|-0.53|0.69|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.69|-0.53|0.5840
71066218|NCT03850483|141641572|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.38||0.0769|TWO_SIDED|90.0|-1.17|0.08|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.08|-1.17|0.0769
71066219|NCT03850483|141641572|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.38||0.0242|TWO_SIDED|90.0|-1.39|-0.13|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.13|-1.39|0.0242
71066220|NCT03850483|141641572|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.38||0.0127|TWO_SIDED|90.0|-1.49|-0.23|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.23|-1.49|0.0127
71066221|NCT03850483|141641572|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.44||0.6693|TWO_SIDED|90.0|-0.54|0.93|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.93|-0.54|0.6693
71111843|NCT00500357|141730554|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.3|0.48|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 19A: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.48|0.30|
71111844|NCT00500357|141730554|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.35|0.67|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 19F: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.67|0.35|
71066222|NCT03850483|141641572|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.45||0.6742|TWO_SIDED|90.0|-0.55|0.96|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.96|-0.55|0.6742
71066223|NCT03850483|141641572|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.44||0.4486|TWO_SIDED|90.0|-0.79|0.67|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.67|-0.79|0.4486
71066224|NCT03850483|141641572|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.44||0.3219|TWO_SIDED|90.0|-0.93|0.53|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.53|-0.93|0.3219
71066225|NCT03850483|141641572|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.55||0.0096|TWO_SIDED|90.0|-2.21|-0.39|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.39|-2.21|0.0096
71066226|NCT03850483|141641572|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.54||0.0862|TWO_SIDED|90.0|-1.64|0.15|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.15|-1.64|0.0862
71066227|NCT03850483|141641572|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.54||0.0111|TWO_SIDED|90.0|-2.15|-0.36|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.36|-2.15|0.0111
71066228|NCT03850483|141641572|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.5||0.6107|TWO_SIDED|90.0|-0.68|0.97|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.97|-0.68|0.6107
71066229|NCT03850483|141641572|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.51||0.724|TWO_SIDED|90.0|-0.54|1.15|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.15|-0.54|0.7240
71066230|NCT03850483|141641572|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.43|TWO_SIDED|90.0|-0.91|0.74|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.74|-0.91|0.4300
71066231|NCT03850483|141641572|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.5||0.0501|TWO_SIDED|90.0|-1.66|0.0|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.00|-1.66|0.0501
71066232|NCT03850483|141641572|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.58||0.0157|TWO_SIDED|90.0|-2.23|-0.3|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.30|-2.23|0.0157
71066233|NCT03850483|141641572|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.57||0.0645|TWO_SIDED|90.0|-1.83|0.07|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.07|-1.83|0.0645
71066234|NCT03850483|141641572|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.57||0.0621|TWO_SIDED|90.0|-1.84|0.06|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.06|-1.84|0.0621
71066235|NCT03850483|141641572|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.55||0.2959|TWO_SIDED|90.0|-1.21|0.62|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.62|-1.21|0.2959
71066236|NCT03850483|141641572|SUPERIORITY||LS mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.57||0.9043|TWO_SIDED|90.0|-0.19|1.69|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.69|-0.19|0.9043
71066237|NCT03850483|141641572|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.55||0.2014|TWO_SIDED|90.0|-1.38|0.45|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.45|-1.38|0.2014
71066238|NCT03850483|141641572|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.56||0.0948|TWO_SIDED|90.0|-1.66|0.19|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.19|-1.66|0.0948
71066239|NCT03850483|141641572|SUPERIORITY||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.65||0.0416|TWO_SIDED|90.0|-2.21|-0.06|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.06|-2.21|0.0416
71066240|NCT03850483|141641572|SUPERIORITY||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.64||0.0454|TWO_SIDED|90.0|-2.14|-0.03|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.03|-2.14|0.0454
71066241|NCT03850483|141641572|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.64||0.0256|TWO_SIDED|90.0|-2.31|-0.2|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.20|-2.31|0.0256
71066242|NCT03850483|141641572|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.57||0.2326|TWO_SIDED|90.0|-1.36|0.53|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.53|-1.36|0.2326
71066243|NCT03850483|141641572|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.59||0.5141|TWO_SIDED|90.0|-0.95|0.99|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.99|-0.95|0.5141
71066244|NCT03850483|141641572|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.57||0.1124|TWO_SIDED|90.0|-1.64|0.25|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.25|-1.64|0.1124
71066245|NCT03850483|141641572|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.58||0.0983|TWO_SIDED|90.0|-1.7|0.21|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.21|-1.70|0.0983
71066246|NCT03850483|141641572|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.72||0.0412|TWO_SIDED|90.0|-2.46|-0.07|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.07|-2.46|0.0412
70938392|NCT03386344|141376938|SUPERIORITY||Difference in LS Means|0.75|STANDARD_ERROR_OF_MEAN|0.462||0.105|TWO_SIDED|95.0|-0.157|1.654|||ANCOVA|||Percent change from baseline to Week 26 was analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline BMD as a covariate.||1.654|-0.157|0.1050
71066247|NCT03850483|141641572|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.71||0.034|TWO_SIDED|90.0|-2.47|-0.13|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.13|-2.47|0.0340
71066248|NCT03850483|141641572|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.71||0.0379|TWO_SIDED|90.0|-2.44|-0.09|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.09|-2.44|0.0379
71066249|NCT03850483|141641572|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.68||0.1291|TWO_SIDED|90.0|-1.91|0.36|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.36|-1.91|0.1291
71066250|NCT03850483|141641572|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.7||0.5776|TWO_SIDED|90.0|-1.03|1.3|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.30|-1.03|0.5776
71066251|NCT03850483|141641572|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.69||0.1044|TWO_SIDED|90.0|-2.0|0.27|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.27|-2.00|0.1044
71066252|NCT03850483|141641572|SUPERIORITY||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.69||0.0608|TWO_SIDED|90.0|-2.23|0.07|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.07|-2.23|0.0608
71066253|NCT03850483|141641572|SUPERIORITY||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.8||0.0309|TWO_SIDED|90.0|-2.84|-0.18|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.18|-2.84|0.0309
71066254|NCT03850483|141641572|SUPERIORITY||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.78||0.0242|TWO_SIDED|90.0|-2.85|-0.26|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.26|-2.85|0.0242
71066255|NCT03850483|141641572|SUPERIORITY||LS mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.78||0.0394|TWO_SIDED|90.0|-2.69|-0.09|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.09|-2.69|0.0394
71066256|NCT03850483|141641574|SUPERIORITY||LS mean difference|2.6|STANDARD_ERROR_OF_MEAN|5.09||0.6917|TWO_SIDED|90.0|-5.86|10.97|||MMRM|||Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||10.97|-5.86|0.6917
71066257|NCT03850483|141641574|SUPERIORITY||LS mean difference|7.3|STANDARD_ERROR_OF_MEAN|5.07||0.9241|TWO_SIDED|90.0|-1.09|15.69|||MMRM|||Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||15.69|-1.09|0.9241
71066258|NCT03850483|141641574|SUPERIORITY||LS mean difference|5.1|STANDARD_ERROR_OF_MEAN|5.03||0.8443|TWO_SIDED|90.0|-3.21|13.42|||MMRM|||Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||13.42|-3.21|0.8443
71066259|NCT03850483|141641574|SUPERIORITY||LS mean difference|2.5|STANDARD_ERROR_OF_MEAN|5.04||0.6911|TWO_SIDED|90.0|-5.82|10.86|||MMRM|||Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||10.86|-5.82|0.6911
71066260|NCT03850483|141641574|SUPERIORITY||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|4.79||0.3676|TWO_SIDED|90.0|-9.56|6.31|||MMRM|||Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||6.31|-9.56|0.3676
71066261|NCT03850483|141641574|SUPERIORITY||LS mean difference|-6.3|STANDARD_ERROR_OF_MEAN|4.72||0.0915|TWO_SIDED|90.0|-14.13|1.5|||MMRM|||Week 1: Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.50|-14.13|0.0915
71066262|NCT03850483|141641574|SUPERIORITY||LS mean difference|-6.2|STANDARD_ERROR_OF_MEAN|4.72||0.097|TWO_SIDED|90.0|-13.96|1.65|||MMRM|||Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.65|-13.96|0.0970
71066263|NCT03850483|141641574|SUPERIORITY||LS mean difference|9.2|STANDARD_ERROR_OF_MEAN|5.91||0.9389|TWO_SIDED|90.0|-0.59|18.97|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||18.97|-0.59|0.9389
71066264|NCT03850483|141641574|SUPERIORITY||LS mean difference|9.0|STANDARD_ERROR_OF_MEAN|6.07||0.9295|TWO_SIDED|90.0|-1.06|19.02|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors||19.02|-1.06|0.9295
71066265|NCT03850483|141641574|SUPERIORITY||LS mean difference|3.7|STANDARD_ERROR_OF_MEAN|5.92||0.7308|TWO_SIDED|90.0|-6.15|13.45|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||13.45|-6.15|0.7308
71066266|NCT03850483|141641574|SUPERIORITY||LS mean difference|1.8|STANDARD_ERROR_OF_MEAN|5.94||0.6199|TWO_SIDED|90.0|-8.01|11.64|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||11.64|-8.01|0.6199
71066267|NCT03850483|141641574|SUPERIORITY||LS mean difference|-9.0|STANDARD_ERROR_OF_MEAN|6.09||0.0699|TWO_SIDED|90.0|-19.13|1.04|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.04|-19.13|0.0699
71066268|NCT03850483|141641574|SUPERIORITY||LS mean difference|-11.6|STANDARD_ERROR_OF_MEAN|6.14||0.03|TWO_SIDED|90.0|-21.79|-1.48|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-1.48|-21.79|0.0300
71066269|NCT03850483|141641574|SUPERIORITY||LS mean difference|-13.1|STANDARD_ERROR_OF_MEAN|6.09||0.0168|TWO_SIDED|90.0|-23.15|-2.98|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-2.98|-23.15|0.0168
71066270|NCT03850483|141641574|SUPERIORITY||LS mean difference|3.6|STANDARD_ERROR_OF_MEAN|6.61||0.7083|TWO_SIDED|90.0|-7.3|14.57|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||14.57|-7.30|0.7083
71066271|NCT03850483|141641574|SUPERIORITY||LS mean difference|8.5|STANDARD_ERROR_OF_MEAN|6.77||0.8955|TWO_SIDED|90.0|-2.66|19.75|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||19.75|-2.66|0.8955
71066272|NCT03850483|141641574|SUPERIORITY||LS mean difference|6.5|STANDARD_ERROR_OF_MEAN|6.56||0.8386|TWO_SIDED|90.0|-4.35|17.37|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||17.37|-4.35|0.8386
71066273|NCT03850483|141641574|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|6.58||0.4371|TWO_SIDED|90.0|-11.93|9.84|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||9.84|-11.93|0.4371
71066274|NCT03850483|141641574|SUPERIORITY||LS mean difference|-20.7|STANDARD_ERROR_OF_MEAN|8.91||0.0108|TWO_SIDED|90.0|-35.42|-5.92|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-5.92|-35.42|0.0108
71066275|NCT03850483|141641574|SUPERIORITY||LS mean difference|-10.9|STANDARD_ERROR_OF_MEAN|8.75||0.1066|TWO_SIDED|90.0|-25.43|3.55|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||3.55|-25.43|0.1066
71066276|NCT03850483|141641574|SUPERIORITY||LS mean difference|-16.0|STANDARD_ERROR_OF_MEAN|8.76||0.0344|TWO_SIDED|90.0|-30.54|-1.55|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-1.55|-30.54|0.0344
71066277|NCT03850483|141641574|SUPERIORITY||LS mean difference|3.4|STANDARD_ERROR_OF_MEAN|8.29||0.6594|TWO_SIDED|90.0|-10.3|17.13|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||17.13|-10.30|0.6594
71066278|NCT03850483|141641574|SUPERIORITY||LS mean difference|5.3|STANDARD_ERROR_OF_MEAN|8.52||0.7307|TWO_SIDED|90.0|-8.85|19.36|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||19.36|-8.85|0.7307
71066279|NCT03850483|141641574|SUPERIORITY||LS mean difference|1.9|STANDARD_ERROR_OF_MEAN|8.28||0.5914|TWO_SIDED|90.0|-11.78|15.61|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||15.61|-11.78|0.5914
70852709|NCT01578850|141194334|SUPERIORITY_OR_OTHER||Difference in proportions|32.0|||<|0.001|TWO_SIDED|95.0|21.83|42.23|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: LDA: Week 44||42.23|21.83|<0.001
70852710|NCT01578850|141194334|SUPERIORITY_OR_OTHER||Difference in proportions|28.3|||<|0.001|TWO_SIDED|95.0|18.0|38.69|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: LDA: Week 52||38.69|18.00|<0.001
71066280|NCT03850483|141641574|SUPERIORITY||LS mean difference|-12.3|STANDARD_ERROR_OF_MEAN|8.34||0.0709|TWO_SIDED|90.0|-26.13|1.49|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.49|-26.13|0.0709
71066281|NCT03850483|141641574|SUPERIORITY||LS mean difference|-18.8|STANDARD_ERROR_OF_MEAN|9.53||0.0253|TWO_SIDED|90.0|-34.55|-3.01|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-3.01|-34.55|0.0253
71066282|NCT03850483|141641574|SUPERIORITY||LS mean difference|-13.4|STANDARD_ERROR_OF_MEAN|9.38||0.078|TWO_SIDED|90.0|-28.89|2.15|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||2.15|-28.89|0.0780
71066283|NCT03850483|141641574|SUPERIORITY||LS mean difference|-9.7|STANDARD_ERROR_OF_MEAN|9.36||0.1516|TWO_SIDED|90.0|-25.17|5.83|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||5.83|-25.17|0.1516
71111845|NCT00500357|141730554|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|1.3|||||TWO_SIDED|95.0|0.86|1.86|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 23F: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||1.86|0.86|
71111846|NCT00500357|141730557|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.34|0.57|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 1: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.57|0.34|
71111847|NCT00500357|141730557|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.66|0.95|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 3: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.95|0.66|
71111848|NCT00500357|141730557|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.76|1.22|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 4: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.22|0.76|
71111849|NCT00500357|141730557|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.57|0.8|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 5: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.80|0.57|
70852711|NCT01578850|141194334|SUPERIORITY_OR_OTHER||Difference in proportions|3.0||||0.672|TWO_SIDED|95.0|-5.51|11.51|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Remission: Week 24||11.51|-5.51|0.672
70852712|NCT01578850|141194334|SUPERIORITY_OR_OTHER||Difference in proportions|0.0||||0.556|TWO_SIDED|95.0|-8.03|8.0|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Remission: Week 28||8.00|-8.03|0.556
71111850|NCT00500357|141730557|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|2.0|||||TWO_SIDED|95.0|1.39|2.84|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 6A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||2.84|1.39|
71111851|NCT00500357|141730557|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.11|1.63|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 6B: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.63|1.11|
71111852|NCT00500357|141730557|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.18|0.41|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 7F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.41|0.18|
70938393|NCT03386344|141376938|SUPERIORITY||Difference in LS Means|0.32|STANDARD_ERROR_OF_MEAN|0.46||0.4804|TWO_SIDED|95.0|-0.577|1.226|||ANCOVA|||Percent change from baseline to Week 26 was analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline BMD as a covariate.||1.226|-0.577|0.4804
70938394|NCT03386344|141376939|SUPERIORITY||Difference in LS Means|-1.91|STANDARD_ERROR_OF_MEAN|0.336|<|0.0001|TWO_SIDED|95.0|-2.568|-1.252|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline body weight as a covariate.||-1.252|-2.568|<0.0001
71066284|NCT03850483|141641574|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|9.14||0.4861|TWO_SIDED|90.0|-15.45|14.81|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||14.81|-15.45|0.4861
71066285|NCT03850483|141641574|SUPERIORITY||LS mean difference|11.0|STANDARD_ERROR_OF_MEAN|9.38||0.8795|TWO_SIDED|90.0|-4.48|26.55|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||26.55|-4.48|0.8795
71066286|NCT03850483|141641574|SUPERIORITY||LS mean difference|-5.1|STANDARD_ERROR_OF_MEAN|9.11||0.2867|TWO_SIDED|90.0|-20.22|9.94|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||9.94|-20.22|0.2867
71066287|NCT03850483|141641574|SUPERIORITY||LS mean difference|-10.6|STANDARD_ERROR_OF_MEAN|9.23||0.1267|TWO_SIDED|90.0|-25.86|4.69|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||4.69|-25.86|0.1267
71066288|NCT03850483|141641574|SUPERIORITY||LS mean difference|-17.1|STANDARD_ERROR_OF_MEAN|10.49||0.0526|TWO_SIDED|90.0|-34.48|0.26|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.26|-34.48|0.0526
71066289|NCT03850483|141641574|SUPERIORITY||LS mean difference|-14.3|STANDARD_ERROR_OF_MEAN|10.25||0.0827|TWO_SIDED|90.0|-31.26|2.68|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||2.68|-31.26|0.0827
71066290|NCT03850483|141641574|SUPERIORITY||LS mean difference|-16.1|STANDARD_ERROR_OF_MEAN|10.26||0.0592|TWO_SIDED|90.0|-33.12|0.86|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.86|-33.12|0.0592
71066291|NCT03850483|141641574|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|9.03||0.4657|TWO_SIDED|90.0|-15.72|14.16|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||14.16|-15.72|0.4657
71066292|NCT03850483|141641574|SUPERIORITY||LS mean difference|3.9|STANDARD_ERROR_OF_MEAN|9.3||0.6612|TWO_SIDED|90.0|-11.52|19.26|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||19.26|-11.52|0.6612
71066293|NCT03850483|141641574|SUPERIORITY||LS mean difference|-8.5|STANDARD_ERROR_OF_MEAN|9.03||0.1749|TWO_SIDED|90.0|-23.42|6.48|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||6.48|-23.42|0.1749
71066294|NCT03850483|141641574|SUPERIORITY||LS mean difference|-9.3|STANDARD_ERROR_OF_MEAN|9.12||0.1548|TWO_SIDED|90.0|-24.39|5.8|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||5.80|-24.39|0.1548
71066295|NCT03850483|141641574|SUPERIORITY||LS mean difference|-21.0|STANDARD_ERROR_OF_MEAN|11.89||0.04|TWO_SIDED|90.0|-40.67|-1.28|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-1.28|-40.67|0.0400
71066296|NCT03850483|141641574|SUPERIORITY||LS mean difference|-22.6|STANDARD_ERROR_OF_MEAN|11.6||0.0267|TWO_SIDED|90.0|-41.82|-3.39|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-3.39|-41.82|0.0267
71066297|NCT03850483|141641574|SUPERIORITY||LS mean difference|-22.2|STANDARD_ERROR_OF_MEAN|11.63||0.0295|TWO_SIDED|90.0|-41.42|-2.89|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-2.89|-41.42|0.0295
71066298|NCT03850483|141641574|SUPERIORITY||LS mean difference|-9.1|STANDARD_ERROR_OF_MEAN|10.38||0.1903|TWO_SIDED|90.0|-26.3|8.05|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||8.05|-26.30|0.1903
71066299|NCT03850483|141641574|SUPERIORITY||LS mean difference|1.4|STANDARD_ERROR_OF_MEAN|10.65||0.553|TWO_SIDED|90.0|-16.21|19.06|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||19.06|-16.21|0.5530
71111853|NCT00500357|141730557|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.27|0.68|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 9V: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.68|0.27|
71066300|NCT03850483|141641574|SUPERIORITY||LS mean difference|-13.8|STANDARD_ERROR_OF_MEAN|10.37||0.0933|TWO_SIDED|90.0|-30.92|3.4|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||3.40|-30.92|0.0933
71066301|NCT03850483|141641574|SUPERIORITY||LS mean difference|-19.0|STANDARD_ERROR_OF_MEAN|10.49||0.036|TWO_SIDED|90.0|-36.37|-1.65|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-1.65|-36.37|0.0360
71066302|NCT03850483|141641574|SUPERIORITY||LS mean difference|-24.5|STANDARD_ERROR_OF_MEAN|13.46||0.0354|TWO_SIDED|90.0|-46.85|-2.23|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-2.23|-46.85|0.0354
71066303|NCT03850483|141641574|SUPERIORITY||LS mean difference|-26.1|STANDARD_ERROR_OF_MEAN|13.07||0.0239|TWO_SIDED|90.0|-47.77|-4.46|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-4.46|-47.77|0.0239
71066304|NCT03850483|141641574|SUPERIORITY||LS mean difference|-24.1|STANDARD_ERROR_OF_MEAN|13.11||0.0342|TWO_SIDED|90.0|-45.84|-2.38|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-2.38|-45.84|0.0342
71066305|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.43||0.3279|TWO_SIDED|90.0|-0.91|0.52|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.52|-0.91|0.3279
71066306|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.44||0.3566|TWO_SIDED|90.0|-0.88|0.56|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.56|-0.88|0.3566
71066307|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.45||0.1165|TWO_SIDED|90.0|-1.29|0.21|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.21|-1.29|0.1165
71066308|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.43||0.3633|TWO_SIDED|90.0|-0.85|0.55|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.55|-0.85|0.3633
71066309|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.42||0.3766|TWO_SIDED|90.0|-0.83|0.56|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.56|-0.83|0.3766
71066310|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.43||0.1179|TWO_SIDED|90.0|-1.22|0.2|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.20|-1.22|0.1179
71066311|NCT03850483|141641576|SUPERIORITY||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.44||0.8647|TWO_SIDED|90.0|-0.24|1.2|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||1.20|-0.24|0.8647
71066312|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.43||0.3294|TWO_SIDED|90.0|-0.9|0.52|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.52|-0.90|0.3294
71066313|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.44||0.1231|TWO_SIDED|90.0|-1.23|0.21|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.21|-1.23|0.1231
71066314|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.45||0.0878|TWO_SIDED|90.0|-1.37|0.13|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.13|-1.37|0.0878
71066315|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.43||0.1225|TWO_SIDED|90.0|-1.2|0.21|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.21|-1.20|0.1225
71111854|NCT00500357|141730557|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.57|0.83|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 14: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.83|0.57|
71111855|NCT00500357|141730557|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.66|1.03|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 18C: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.03|0.66|
71111856|NCT00500357|141730557|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.58|0.78|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 19A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.78|0.58|
71111857|NCT00500357|141730557|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.47|0.73|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 19F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.73|0.47|
71111858|NCT00500357|141730557|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|1.5|||||TWO_SIDED|95.0|1.18|1.94|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 23F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.94|1.18|
71111859|NCT00500357|141730558|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.65|||||TWO_SIDED|95.0|0.52|0.82|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 1: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.82|0.52|
71111860|NCT00500357|141730558|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.52|||||TWO_SIDED|95.0|0.43|0.62|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 3: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.62|0.43|
71066316|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.43||0.3663|TWO_SIDED|90.0|-0.85|0.56|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.56|-0.85|0.3663
71066317|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.43||0.0929|TWO_SIDED|90.0|-1.27|0.14|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.14|-1.27|0.0929
71066318|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.44||0.3111|TWO_SIDED|90.0|-0.95|0.51|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.51|-0.95|0.3111
71066319|NCT03850483|141641576|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.43||0.4745|TWO_SIDED|90.0|-0.74|0.69|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.69|-0.74|0.4745
71111861|NCT00500357|141730558|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.63|||||TWO_SIDED|95.0|0.53|0.76|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 4: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.76|0.53|
71111862|NCT00500357|141730558|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.32|||||TWO_SIDED|95.0|0.27|0.39|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 5: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.39|0.27|
71111863|NCT00500357|141730558|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.74|1.1|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 6A: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||1.10|0.74|
71111864|NCT00500357|141730558|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.79|||||TWO_SIDED|95.0|0.63|0.99|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 6B: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.99|0.63|
71066320|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.44||0.2409|TWO_SIDED|90.0|-1.03|0.42|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.42|-1.03|0.2409
71066321|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.45||0.2018|TWO_SIDED|90.0|-1.13|0.37|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.37|-1.13|0.2018
71066322|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.43||0.3925|TWO_SIDED|90.0|-0.83|0.59|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.59|-0.83|0.3925
71111865|NCT00500357|141730558|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.72|||||TWO_SIDED|95.0|0.6|0.87|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 7F: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.87|0.60|
71066323|NCT03850483|141641576|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.42||0.5348|TWO_SIDED|90.0|-0.66|0.73|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.73|-0.66|0.5348
71066324|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.43||0.0739|TWO_SIDED|90.0|-1.33|0.09|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.09|-1.33|0.0739
71066325|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.44||0.4014|TWO_SIDED|90.0|-0.84|0.62|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.62|-0.84|0.4014
71066326|NCT03850483|141641576|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.45||0.6588|TWO_SIDED|90.0|-0.56|0.93|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.93|-0.56|0.6588
71066327|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.46||0.2997|TWO_SIDED|90.0|-1.0|0.52|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.52|-1.00|0.2997
71066328|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.47||0.2518|TWO_SIDED|90.0|-1.08|0.46|||MMRM|||Week 4:MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.46|-1.08|0.2518
71066329|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.44||0.2634|TWO_SIDED|90.0|-1.0|0.45|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.45|-1.00|0.2634
71066330|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.45||0.1999|TWO_SIDED|90.0|-1.11|0.36|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.36|-1.11|0.1999
71111866|NCT00500357|141730558|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.42|0.6|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 9V: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.60|0.42|
71111867|NCT00500357|141730558|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.76|||||TWO_SIDED|95.0|0.59|0.98|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 14: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.98|0.59|
71111868|NCT00500357|141730558|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.38|||||TWO_SIDED|95.0|0.31|0.46|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 18C: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.46|0.31|
71066331|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.44||0.1847|TWO_SIDED|90.0|-1.13|0.33|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.33|-1.13|0.1847
71066332|NCT03850483|141641576|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.46||0.4569|TWO_SIDED|90.0|-0.81|0.71|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.71|-0.81|0.4569
71066333|NCT03850483|141641576|SUPERIORITY||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.45||0.8536|TWO_SIDED|90.0|-0.27|1.22|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||1.22|-0.27|0.8536
71066334|NCT03850483|141641576|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.46||0.4812|TWO_SIDED|90.0|-0.79|0.74|||MMRM|||Week 6:MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.74|-0.79|0.4812
71066335|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.47||0.2276|TWO_SIDED|90.0|-1.13|0.42|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.42|-1.13|0.2276
71111869|NCT00500357|141730558|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.49|0.74|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 19A: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.74|0.49|
71111870|NCT00500357|141730558|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.64|||||TWO_SIDED|95.0|0.52|0.79|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 19F: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.79|0.52|
71111871|NCT00500357|141730558|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.76|||||TWO_SIDED|95.0|0.62|0.93|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 23F: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.93|0.62|
70938395|NCT03386344|141376939|SUPERIORITY||Difference in LS Means|-1.7|STANDARD_ERROR_OF_MEAN|0.335|<|0.0001|TWO_SIDED|95.0|-2.36|-1.046|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline body weight as a covariate.||-1.046|-2.360|<0.0001
70938396|NCT03386344|141376940|SUPERIORITY||Difference in LS Means|-18.891|STANDARD_ERROR_OF_MEAN|4.5766|<|0.0001|TWO_SIDED|95.0|-27.8605|-9.9205|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, baseline fasting plasma glucose as a covariate.||-9.9205|-27.8605|<0.0001
70938397|NCT03386344|141376940|SUPERIORITY||Difference in LS Means|-21.333|STANDARD_ERROR_OF_MEAN|4.5902|<|0.0001|TWO_SIDED|95.0|-30.3294|-12.336|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, baseline fasting plasma glucose as a covariate.||-12.3360|-30.3294|<0.0001
70938398|NCT03386344|141376941|SUPERIORITY||Difference in LS Means|-0.8|STANDARD_ERROR_OF_MEAN|1.48||0.5864|TWO_SIDED|95.0|-3.705|2.095|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline SBP as a covariate.||2.095|-3.705|0.5864
70938399|NCT03386344|141376941|SUPERIORITY||Difference in LS Means|-1.16|STANDARD_ERROR_OF_MEAN|1.478||0.4315|TWO_SIDED|95.0|-4.058|1.734|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline SBP as a covariate.||1.734|-4.058|0.4315
70938400|NCT03386344|141376942|SUPERIORITY||Percentage Difference|10.5||||0.0172|TWO_SIDED|95.0|1.78|19.23|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups from randomization strata of HbA1c (≤8.5, \>8.5%) at screening and randomization strata of sex (male, female) using Cochran-Mantel-Haenszel weights.||19.23|1.78|0.0172
71066336|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.45||0.0895|TWO_SIDED|90.0|-1.34|0.14|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.14|-1.34|0.0895
71066337|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.47||0.0411|TWO_SIDED|90.0|-1.58|-0.04|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.04|-1.58|0.0411
71066338|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.47||0.0928|TWO_SIDED|90.0|-1.4|0.15|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.15|-1.40|0.0928
70938401|NCT03386344|141376942|SUPERIORITY||Percentage Difference|12.0||||0.0076|TWO_SIDED|95.0|3.23|20.86|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups from randomization strata of HbA1c (≤8.5, \>8.5%) at screening and randomization strata of sex (male, female) using Cochran-Mantel-Haenszel weights.||20.86|3.23|0.0076
70938402|NCT00237718|141376953|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
70938403|NCT00237718|141376954|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71066339|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.49||0.0799|TWO_SIDED|90.0|-1.48|0.12|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.12|-1.48|0.0799
71066340|NCT03850483|141641576|SUPERIORITY||LS mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.46||0.7872|TWO_SIDED|90.0|-0.39|1.11|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||1.11|-0.39|0.7872
71066341|NCT03850483|141641576|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.47||0.6294|TWO_SIDED|90.0|-0.61|0.92|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.92|-0.61|0.6294
70938404|NCT02991118|141376955|SUPERIORITY||Difference in LS mean|-17.42|STANDARD_ERROR_OF_MEAN|1.8|<|0.001|TWO_SIDED|95.0|-20.951|-13.896|||ANCOVA|||||-13.896|-20.951|<0.001
70938405|NCT02991118|141376956|SUPERIORITY||Difference in LS mean|-14.77|STANDARD_ERROR_OF_MEAN|2.418|<|0.001|TWO_SIDED|95.0|-19.504|-10.027|||ANCOVA|||||-10.027|-19.504|<0.001
70938406|NCT02991118|141376957|SUPERIORITY||Difference in LS mean|-13.03|STANDARD_ERROR_OF_MEAN|1.652|<|0.001|TWO_SIDED|95.0|-16.27|-9.794|||ANCOVA|||||-9.794|-16.270|<0.001
70938407|NCT02991118|141376958|SUPERIORITY||Difference in LS mean|-11.2|STANDARD_ERROR_OF_MEAN|1.224|<|0.001|TWO_SIDED|95.0|-13.599|-8.801|||ANCOVA|||||-8.801|-13.599|<0.001
70938408|NCT02991118|141376959|SUPERIORITY||Difference in LS mean|-13.02|STANDARD_ERROR_OF_MEAN|1.587|<|0.001|TWO_SIDED|95.0|-16.13|-9.907|||ANCOVA|||||-9.907|-16.130|<0.001
70938409|NCT02991118|141376960|SUPERIORITY||Location shift|-8.733|||<|0.039|TWO_SIDED|95.0|-17.238|-0.434|||Wilcoxon Rank Sum Test||The location shift and asymptotic 95% confidence interval are based on Hodges-Lehman estimation.|||-0.434|-17.238|<0.039
71111872|NCT00500357|141730559|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.68|||||TWO_SIDED|95.0|0.6|0.78|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 1: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.78|0.60|
70938410|NCT02991118|141376963|SUPERIORITY||Difference in LS mean|4.89|STANDARD_ERROR_OF_MEAN|3.258||0.134|TWO_SIDED|95.0|-1.504|11.292|||ANCOVA|||||11.292|-1.504|0.134
70938411|NCT02991118|141376964|SUPERIORITY||Difference in LS mean|-6.13|STANDARD_ERROR_OF_MEAN|1.139|<|0.001|TWO_SIDED|95.0|-8.369|-3.896|||ANCOVA|||||-3.896|-8.369|<0.001
70938412|NCT02991118|141376965|SUPERIORITY||Difference in LS mean|-12.27|STANDARD_ERROR_OF_MEAN|2.314|<|0.001|TWO_SIDED|95.0|-16.813|-7.722|||ANCOVA|||||-7.722|-16.813|<0.001
71066342|NCT03850483|141641576|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.48||0.5174|TWO_SIDED|90.0|-0.76|0.8|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.80|-0.76|0.5174
71066343|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.46||0.3136|TWO_SIDED|90.0|-0.98|0.53|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.53|-0.98|0.3136
71066344|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.48||0.102|TWO_SIDED|90.0|-1.42|0.18|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.18|-1.42|0.1020
71066345|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.47||0.1923|TWO_SIDED|90.0|-1.2|0.37|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.37|-1.20|0.1923
71066346|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.49||0.0997|TWO_SIDED|90.0|-1.44|0.18|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.18|-1.44|0.0997
71066347|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.47||0.2497|TWO_SIDED|90.0|-1.08|0.45|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.45|-1.08|0.2497
70938413|NCT02991118|141376966|SUPERIORITY||Difference in LS mean|-12.63|STANDARD_ERROR_OF_MEAN|2.01|<|0.001|TWO_SIDED|95.0|-16.58|-8.682|||ANCOVA|||||-8.682|-16.580|<0.001
71066348|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.47||0.2568|TWO_SIDED|90.0|-1.08|0.47|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.47|-1.08|0.2568
71066349|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.48||0.373|TWO_SIDED|90.0|-0.95|0.64|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.64|-0.95|0.3730
71066350|NCT03850483|141641576|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.46||0.0137|TWO_SIDED|90.0|-1.76|-0.26|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.26|-1.76|0.0137
71066351|NCT03850483|141641576|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.49||0.0055|TWO_SIDED|90.0|-2.06|-0.44|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.44|-2.06|0.0055
71066352|NCT03850483|141641576|SUPERIORITY||LS mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.48||0.0069|TWO_SIDED|90.0|-1.99|-0.4|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.40|-1.99|0.0069
71066353|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.51||0.1648|TWO_SIDED|90.0|-1.34|0.34|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.34|-1.34|0.1648
71066354|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.46||0.2931|TWO_SIDED|90.0|-1.02|0.51|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.51|-1.02|0.2931
70938414|NCT02991118|141376967|SUPERIORITY||Difference in LS mean|-9.92|STANDARD_ERROR_OF_MEAN|1.976|<|0.001|TWO_SIDED|95.0|-13.803|-6.037|||ANCOVA|||||-6.037|-13.803|<0.001
70938415|NCT02991118|141376968|SUPERIORITY||Difference in LS mean|-10.77|STANDARD_ERROR_OF_MEAN|1.489|<|0.001|TWO_SIDED|95.0|-13.698|-7.848|||ANCOVA|||||-7.848|-13.698|<0.001
70938416|NCT02991118|141376969|SUPERIORITY||Difference in LS mean|-8.36|STANDARD_ERROR_OF_MEAN|1.458|<|0.001|TWO_SIDED|95.0|-11.223|-5.493|||ANCOVA|||||-5.493|-11.223|<0.001
70938417|NCT02991118|141376970|SUPERIORITY||Difference in LS mean|-13.0|STANDARD_ERROR_OF_MEAN|2.451|<|0.001|TWO_SIDED|95.0|-17.829|-8.175|||ANCOVA|||||-8.175|-17.829|<0.001
70938418|NCT02991118|141376971|SUPERIORITY||Difference in LS mean|-9.58|STANDARD_ERROR_OF_MEAN|1.796|<|0.001|TWO_SIDED|95.0|-13.107|-6.047|||ANCOVA|||||-6.047|-13.107|<0.001
71066355|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.47||0.3047|TWO_SIDED|90.0|-1.01|0.53|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.53|-1.01|0.3047
71066356|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.48||0.1924|TWO_SIDED|90.0|-1.22|0.38|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.38|-1.22|0.1924
71066357|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.46||0.0465|TWO_SIDED|90.0|-1.52|-0.02|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.02|-1.52|0.0465
71066358|NCT03850483|141641576|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.49||0.0048|TWO_SIDED|90.0|-2.08|-0.47|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.47|-2.08|0.0048
71066359|NCT03850483|141641576|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.48||0.0186|TWO_SIDED|90.0|-1.78|-0.21|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.21|-1.78|0.0186
71066360|NCT03850483|141641576|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.51||0.0675|TWO_SIDED|90.0|-1.61|0.08|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.08|-1.61|0.0675
71066361|NCT03850483|141641578|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.33||0.3232|TWO_SIDED|90.0|-0.69|0.39|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.39|-0.69|0.3232
71066362|NCT03850483|141641578|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.33||0.0736|TWO_SIDED|90.0|-1.03|0.07|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.07|-1.03|0.0736
71066363|NCT03850483|141641578|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.35||0.0743|TWO_SIDED|90.0|-1.07|0.07|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.07|-1.07|0.0743
71066364|NCT03850483|141641578|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.32||0.0641|TWO_SIDED|90.0|-1.03|0.04|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.04|-1.03|0.0641
71066365|NCT03850483|141641578|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.36||0.3887|TWO_SIDED|90.0|-0.71|0.5|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.50|-0.71|0.3887
71066366|NCT03850483|141641578|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.37||0.0767|TWO_SIDED|90.0|-1.15|0.08|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.08|-1.15|0.0767
71066367|NCT03850483|141641578|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.38||0.2529|TWO_SIDED|90.0|-0.89|0.38|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.38|-0.89|0.2529
71066368|NCT03850483|141641578|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.39||0.5304|TWO_SIDED|90.0|-0.61|0.67|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.67|-0.61|0.5304
71066369|NCT03850483|141641578|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.39||0.292|TWO_SIDED|90.0|-0.87|0.43|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.43|-0.87|0.2920
71066370|NCT03850483|141641578|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.41||0.2593|TWO_SIDED|90.0|-0.7|0.57|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.57|-0.70|0.2593
71066371|NCT03850483|141641578|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.38||0.431|TWO_SIDED|90.0|-0.7|0.57|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.57|-0.70|0.4310
71066372|NCT03850483|141641578|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.39||0.5477|TWO_SIDED|90.0|-0.59|0.69|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.69|-0.59|0.5477
70938419|NCT02991118|141376972|SUPERIORITY||Location shift|-21.278|||<|0.001|TWO_SIDED|95.0|-32.25|-10.034|||Wilcoxon Rank Sum Test||The location shift and asymptotic 95% confidence interval are based on Hodges-Lehman estimation.|||-10.034|-32.250|<0.001
70938420|NCT02991118|141376973|SUPERIORITY||Location shift|-7.587||||0.102|TWO_SIDED|95.0|-16.978|1.653|||Wilcoxon Rank Sum Test||The location shift and asymptotic 95% confidence interval are based on Hodges-Lehman estimation.|||1.653|-16.978|0.102
70938421|NCT02991118|141376974|SUPERIORITY||Difference in LS mean|-15.07|STANDARD_ERROR_OF_MEAN|2.641|<|0.001|TWO_SIDED|95.0|-20.26|-9.878|||ANCOVA|||||-9.878|-20.260|<0.001
70938422|NCT00595959|141376975|SUPERIORITY_OR_OTHER|||||||0.001||||||No adjustments|t-test, 1 sided|||Comparing to an expected value of 20% reduction from initial to post-laser||||0.001
70938423|NCT02077374|141376991|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.0||||0.0195|TWO_SIDED|95.0|-30.7|-2.5|||Wilcoxon (Mann-Whitney)||Based on Hodges-Lehmann estimator|Statistical Analysis for the difference in mean change in alanine aminotransferase (ALT) from Baseline to Day28/ET between IDN-6556 and placebo||-2.5|-30.7|0.0195
70938424|NCT02077374|141376993|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.8||||0.8724|TWO_SIDED|95.0|-14.5|11.2|||Wilcoxon (Mann-Whitney)||Based on Hodges-Lehmann estimator|Statistical Analysis for the difference in change in aspartate aminotransferase (AST) from baseline to Day 28/ET between IDN-6556 and placebo||11.2|-14.5|0.8724
70938425|NCT02077374|141376994|SUPERIORITY_OR_OTHER||Median Difference (Net)|-145.0||||0.1149|TWO_SIDED|95.0|-336.0|55.0|||Wilcoxon (Mann-Whitney)||Based on Hodges-Lehmann estimator|Statistical Analysis for the difference in change for cCK18/M30 from Baseline to Day 28/ET between IDN-6556 and Placebo||55|-336|0.1149
71111873|NCT00500357|141730559|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.55|||||TWO_SIDED|95.0|0.48|0.64|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 3: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.64|0.48|
70938426|NCT02077374|141376995|SUPERIORITY_OR_OTHER||Median Difference (Net)|-250.0||||0.1365|TWO_SIDED|95.0|-590.0|63.0|||Wilcoxon (Mann-Whitney)||Based on Hodges-Lehmann estimator|Statistical Analysis for the difference in change for caspase 3/7 from Baseline to Day 28/ET between IDN-6556 and Placebo||63|-590|0.1365
70938427|NCT02077374|141376996|SUPERIORITY_OR_OTHER||Median Difference (Net)|-327.0||||0.0471|TWO_SIDED|95.0|-628.0|-7.0|||Wilcoxon (Mann-Whitney)||Based on Hodges-Lehmann estimator|Statistical Analysis of the difference in the change in full-length cytokeratine 18 (flCK18/M65) from Baseline to Day 28/ET between IDN-6556 and placebo||-7|-628|0.0471
70938428|NCT03032965|141377008|SUPERIORITY|||||||0.83|||||||Log Rank|Kaplan Meier log rank||||||.83
70938429|NCT03032965|141377009|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||.35
70938430|NCT03032965|141377011|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
70938431|NCT00636168|141377017|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0013|TWO_SIDED|95.0|0.64|0.9|||Log Rank|stratified 2-sided log-rank test||The hazard ratio, and its 95 % confidence interval was estimated using a Cox proportional hazards model, stratified by stage (IIIa vs. IIIb vs. IIIc with 1-3 positive lymph-nodes vs. IIIc with \>= 4 positive lymph-nodes) as indicated at randomization, with treatment as the single covariate.. The analysis was performed after 528 RFS events per IRC were reported. Two-sided, 95% confidence intervals for median RFS were computed by the Brookmeyer and Crowley method using log-log transformation.||0.90|0.64|0.0013
70938432|NCT00636168|141377020|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0024|TWO_SIDED|95.8|0.64|0.92|||Log Rank|stratified 2-sided log-rank test||Medians and associated 2-sided 95% confidence intervals are calculated using the method of Brookmeyer and Crowley. Analysis was stratified for stage (IIIa vs. IIIb vs. IIIc with 1-3 positive lymph-nodes vs. IIIc with \>= 4 positive lymph-nodes) as recorded at randomization. P-value was based on stratified 2-sided log-rank test. Hazard of 10 mg/kg Ipilimumab over hazard of Placebo, with 2-sided 95.8% confidence interval are based on a stratified Cox proportional hazards model||0.92|0.64|0.0024
70938433|NCT00636168|141377023|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0013|TWO_SIDED|95.1|0.58|0.88|||Log Rank|stratified 2-sided log-rank test||Medians and associated 2-sided 95% confidence intervals are calculated using the method of Brookmeyer and Crowley. Analysis was stratified for stage (IIIa vs. IIIb vs. IIIc with 1-3 positive lymph-nodes vs. IIIc with \>= 4 positive lymph-nodes) as recorded at randomization. P-value was based on stratified 2-sided log-rank test. Hazard of 10 mg/kg Ipilimumab over hazard of Placebo, with 2-sided 95.1% confidence interval are based on a stratified Cox proportional hazards model||0.88|0.58|0.0013
70938434|NCT02707952|141377032|NON_INFERIORITY|The percentage of participants achieving SVR12 was calculated for each arm and a 2-sided 95% CI for the difference in SVR12 rates (Arm A minus Arm B) was calculated using the normal approximation to the binomial distribution to assess non-inferiority in SVR12 rates of arm A to arm B. If the lower bound of the confidence interval (CI) for the difference was above the non-inferiority margin of -10%, then arm A was considered non-inferior to arm B.|Rate Difference|-0.9|||||TWO_SIDED|95.0|-2.8|0.9|||||95% CI was calculated using the normal approximation to the binomial distribution.|||0.9|-2.8|
70938435|NCT02006641|141377037|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.51||1|TWO_SIDED|95.0|-1.1|0.92||Corrected for multiplicity|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.||0.92|-1.10|1.000
71111874|NCT00500357|141730559|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.75|||||TWO_SIDED|95.0|0.65|0.87|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 4: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.87|0.65|
70938436|NCT02006641|141377037|SUPERIORITY||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.52||0.2223|TWO_SIDED|95.0|-0.38|1.65||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.||1.65|-0.38|0.2223
70941782|NCT04748445|141383935|OTHER||Slope|-1.88|STANDARD_ERROR_OF_MEAN|1.174||0.1119|TWO_SIDED|90.0|-3.826|6.611|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 06 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit, estimated value and dispersion value it was 10\^-4. For upper limit it was 10\^-6).||6.611|-3.826|0.1119
70941783|NCT04748445|141383935|OTHER||Slope|1.667|STANDARD_ERROR_OF_MEAN|1.164||0.1545|TWO_SIDED|90.0|-2.615|3.596|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 07 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-4. For lower limit it was 10\^-5).||3.596|-2.615|0.1545
71066373|NCT03850483|141641578|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.39||0.0696|TWO_SIDED|90.0|-1.24|0.07|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.07|-1.24|0.0696
71066374|NCT03850483|141641578|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.41||0.3583|TWO_SIDED|90.0|-0.82|0.53|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.53|-0.82|0.3583
71066375|NCT03850483|141641578|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.47||0.6826|TWO_SIDED|90.0|-0.56|1.01|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.01|-0.56|0.6826
71066376|NCT03850483|141641578|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.48||0.457|TWO_SIDED|90.0|-0.84|0.74|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.74|-0.84|0.4570
71066377|NCT03850483|141641578|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.49||0.3265|TWO_SIDED|90.0|-1.03|0.59|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.59|-1.03|0.3265
71066378|NCT03850483|141641578|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.46||0.3039|TWO_SIDED|90.0|-1.0|0.53|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.53|-1.00|0.3039
71066379|NCT03850483|141641578|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.5||0.2086|TWO_SIDED|90.0|-1.23|0.42|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.42|-1.23|0.2086
71066380|NCT03850483|141641578|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.5||0.2172|TWO_SIDED|90.0|-1.22|0.44|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.44|-1.22|0.2172
71111875|NCT00500357|141730559|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.68|||||TWO_SIDED|95.0|0.61|0.76|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 5: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.76|0.61|
71111876|NCT00500357|141730559|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.49|||||TWO_SIDED|95.0|1.27|1.75|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 6A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.75|1.27|
71111877|NCT00500357|141730559|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.07|||||TWO_SIDED|95.0|0.94|1.21|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 6B: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.21|0.94|
71111878|NCT00500357|141730559|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.68|||||TWO_SIDED|95.0|0.58|0.79|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 7F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.79|0.58|
71111879|NCT00500357|141730559|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.53|0.68|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 9V: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.68|0.53|
71111880|NCT00500357|141730559|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.59|||||TWO_SIDED|95.0|0.51|0.67|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 14: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.67|0.51|
71111881|NCT00500357|141730559|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.67|||||TWO_SIDED|95.0|0.6|0.74|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 18C: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.74|0.60|
70938437|NCT02006641|141377038|SUPERIORITY||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.65||1|TWO_SIDED|95.0|-1.11|1.46||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A positive mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.||1.46|-1.11|1.000
71111882|NCT00500357|141730559|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.78|||||TWO_SIDED|95.0|0.69|0.88|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 19A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.88|0.69|
71111883|NCT00500357|141730559|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.54|||||TWO_SIDED|95.0|0.47|0.62|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 19F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.62|0.47|
71111884|NCT00500357|141730559|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.06|||||TWO_SIDED|95.0|0.9|1.25|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 23F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.25|0.90|
71111885|NCT01734785|141730575|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001||95.0|-0.93|-0.46|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 25 mg minus Placebo.|Superiority of Empagliflozin 25 mg vs. placebo: change in HbA1c using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c as linear covariate(s) \& baseline Estimated glomerula filtration rate (eGFR), geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).||-0.46|-0.93|<0.0001
71111886|NCT01734785|141730575|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001||95.0|-1.02|-0.55|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 10 mg minus Placebo.|Superiority of Empagliflozin 10 mg vs. placebo: change in HbA1c using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c as linear covariate(s) \& baseline Estimated glomerula filtration rate (eGFR), geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).||-0.55|-1.02|<0.0001
71111887|NCT01734785|141730576|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.09|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001||95.0|-2.61|-1.57|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 25 mg minus Placebo.|Superiority of Empagliflozin 25 mg vs. placebo: change in FPG using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline FPG, baseline HbA1c as linear covariate(s) \& baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).||-1.57|-2.61|<0.0001
71111888|NCT01734785|141730576|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001||95.0|-2.31|-1.28|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 10 mg minus Placebo.|Superiority of Empagliflozin 10 mg vs. placebo: change in FPG using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline FPG, baseline HbA1c as linear covariate(s) \& baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).||-1.28|-2.31|<0.0001
71111889|NCT01734785|141730577|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.22|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001||95.0|-2.92|-1.52|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 25 mg minus Placebo.|Superiority of Empagliflozin 25 mg vs. placebo: change in body weight using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline weight, baseline HbA1c as linear covariate(s) \& baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).||-1.52|-2.92|<0.0001
71111890|NCT01734785|141730577|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.77|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001||95.0|-3.47|-2.07|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 10 mg minus Placebo.|Superiority of Empagliflozin 10 mg vs. placebo:change in body weight using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline weight, baseline HbA1c as linear covariate(s) \& baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).||-2.07|-3.47|<0.0001
71111891|NCT00161616|141730578|SUPERIORITY_OR_OTHER|||||||0.0541|||||||Fisher Exact|||Comparison of Healed vs Not healed/No outcome for week 13.||||0.0541
71111892|NCT00161616|141730578|SUPERIORITY_OR_OTHER|||||||0.7983|||||||Fisher Exact|||Comparison of Healed vs Not healed/No outcome for week 20.||||0.7983
71111893|NCT00161616|141730579|SUPERIORITY_OR_OTHER|||||||0.8961|||||||Fisher Exact|||||||0.8961
71111894|NCT00861757|141730587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.6||0.003|TWO_SIDED|95.0|-3.0|-0.6|||ANCOVA|||||-0.6|-3.0|0.003
71111895|NCT00861757|141730587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.6||0.004|TWO_SIDED|95.0|-2.9|-0.6|||ANCOVA|||||-0.6|-2.9|0.004
71111896|NCT00861757|141730587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-3.7|-1.3|||ANCOVA|||||-1.3|-3.7|<0.001
71111897|NCT00861757|141730588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.2|-0.6||This is the p value for the Voiding (Obstructive) Score.|ANCOVA|||||-0.6|-2.2|<0.001
70852713|NCT01578850|141194334|SUPERIORITY_OR_OTHER||Difference in proportions|10.3||||0.022|TWO_SIDED|95.0|2.07|18.45|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Remission: Week 36||18.45|2.07|0.022
70938438|NCT02006641|141377038|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.66||1|TWO_SIDED|95.0|-1.27|1.33||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A positive mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.||1.33|-1.27|1.000
71028352|NCT02270736|141564041|SUPERIORITY||Least square mean (LS-mean) difference|0.4|STANDARD_ERROR_OF_MEAN|0.116|=|0.0008|TWO_SIDED|95.0|0.17|0.63|||MMRM|||Statistical analysis at Week 8: LS-Mean is from a MMRM analysis model with treatment group, pooled investigation sites, and age groups as fixed factors, visit\*treatment as interaction term, visit as repeated factor, and baseline mTDS score as covariate.||0.63|0.17|=0.0008
71028353|NCT02270736|141564041|SUPERIORITY||Least square mean (LS-mean) difference|0.4|STANDARD_ERROR_OF_MEAN|0.132|=|0.0026|TWO_SIDED|95.0|0.14|0.66|||MMRM|||Statistical analysis at Week 12: LS-Mean is from a MMRM analysis model with treatment group, pooled investigation sites, and age groups as fixed factors, visit\*treatment as interaction term, visit as repeated factor, and baseline mTDS score as covariate.||0.66|0.14|=0.0026
71028354|NCT00067236|141564086|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.0||||0.4239|TWO_SIDED|95.0|||||ANOVA|||Changes from baseline in efficacy parameters at Day 90.||||0.4239
71066381|NCT03850483|141641578|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.52||0.2855|TWO_SIDED|90.0|-1.16|0.57|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.57|-1.16|0.2855
71028355|NCT01124149|141564122|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.61|||<|0.001|TWO_SIDED|95.0|1.76|3.87|||Regression, Logistic|||||3.87|1.76|<0.001
71028356|NCT01124149|141564123|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.1|||<|0.001|TWO_SIDED|95.0|1.44|3.07|||Regression, Logistic|||||3.07|1.44|<0.001
71066382|NCT03850483|141641578|SUPERIORITY||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.51||0.8372|TWO_SIDED|90.0|-0.34|1.36|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.36|-0.34|0.8372
71028357|NCT01644500|141564130|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.58|||<|0.001|TWO_SIDED|95.0|-0.76|-0.39|||Mixed Models Analysis|||||-0.39|-0.76|<0.001
71028358|NCT01644500|141564130|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.32|||<|0.001|TWO_SIDED|95.0|-0.5|-0.13|||Mixed Models Analysis|||||-0.13|-0.50|<0.001
71028359|NCT01644500|141564131|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.7|||<|0.001|TWO_SIDED|5.0|1.8|4.1||Treatment comparison for HbA1c ≤6.5%.|Fisher Exact|||||4.1|1.8|<0.001
71066383|NCT03850483|141641578|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.52||0.4792|TWO_SIDED|90.0|-0.89|0.84|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.84|-0.89|0.4792
71028360|NCT01644500|141564131|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.0|2.3||Treatment comparison for HbA1c ≤6.5%.|Fisher Exact|||||2.3|1.0|<0.001
71028361|NCT01644500|141564131|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.9|||<|0.001|TWO_SIDED|95.0|1.8|4.5||Treatment comparison for HbA1c \<7.0%.|Fisher Exact|||||4.5|1.8|<0.001
71028362|NCT01644500|141564131|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.6||||0.192|TWO_SIDED|95.0|1.1|2.5||Treatment comparison for HbA1c \<7.0%.|Fisher Exact|||||2.5|1.1|0.192
71028363|NCT01644500|141564132|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.83|||<|0.001|TWO_SIDED|95.0|-1.15|-0.51|||Mixed Models Analysis|||||-0.51|-1.15|<0.001
71028364|NCT01644500|141564132|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.38||||0.022|TWO_SIDED|95.0|-0.7|-0.05|||Mixed Models Analysis|||||-0.05|-0.70|0.022
71028365|NCT01644500|141564133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.67|||<|0.001|TWO_SIDED|95.0|-0.89|-0.45||Treatment comparison for morning (fasting).|Mixed Models Analysis|||||-0.45|-0.89|<0.001
71028366|NCT01644500|141564133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.12||||0.304|TWO_SIDED|95.0|-0.34|0.11||Treatment comparison for morning (fasting).|Mixed Models Analysis|||||0.11|-0.34|0.304
71028367|NCT01644500|141564133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.36|||<|0.001|TWO_SIDED|95.0|-1.8|-0.92||Treatment comparison for morning (2 hours post-prandial) meal.|Mixed Models Analysis|||||-0.92|-1.80|<0.001
71028368|NCT01644500|141564133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.55||||0.015|TWO_SIDED|95.0|-0.99|-0.11||Treatment comparison for morning (2 hours post-prandial) meal.|Mixed Models Analysis|||||-0.11|-0.99|0.015
71028369|NCT01644500|141564133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.73|||<|0.001|TWO_SIDED|95.0|-1.1|-0.36||Treatment comparison for midday (pre-prandial) meal.|Mixed Models Analysis|||||-0.36|-1.10|<0.001
71028370|NCT01644500|141564133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.06||||0.74|TWO_SIDED|95.0|-0.43|0.31||Treatment comparison for midday (pre-prandial) meal.|Mixed Models Analysis|||||0.31|-0.43|0.740
71028371|NCT01644500|141564133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.56|||<|0.001|TWO_SIDED|95.0|-1.99|-1.13||Treatment comparison of midday (2 hours post-prandial) meal.|Mixed Models Analysis|||||-1.13|-1.99|<0.001
70941784|NCT04748445|141383935|OTHER||Slope|1.531|STANDARD_ERROR_OF_MEAN|9.552||0.1114|TWO_SIDED|90.0|-5.164|3.114|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 08 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and estimated value it was 10\^-4. For lower limit it was 10\^-6 and for dispersion value it was 10\^-5).||3.114|-5.164|0.1114
71111898|NCT00861757|141730588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.4||0.005|TWO_SIDED|95.0|-1.9|-0.3||This is the p value for the Voiding (Obstructive) Score.|ANCOVA|||||-0.3|-1.9|0.005
71111899|NCT00861757|141730588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.7|-1.1||This is the p value for the Voiding (Obstructive) Score.|ANCOVA|||||-1.1|-2.7|<0.001
71111900|NCT00861757|141730588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.072|TWO_SIDED|95.0|-1.0|0.0||This is the p value for the Storage (Irritative) Score.|ANCOVA|||||0.0|-1.0|0.072
71111901|NCT00861757|141730588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.021|TWO_SIDED|95.0|-1.1|-0.1||This is the p value for the Storage (Irritative) Score.|ANCOVA|||||-0.1|-1.1|0.021
71111902|NCT00861757|141730588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.023|TWO_SIDED|95.0|-1.1|-0.1||This is the p value for the Storage (Irritative) Score.|ANCOVA|||||-0.1|-1.1|0.023
71111903|NCT00861757|141730589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.031|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||-0.0|-0.6|0.031
71111904|NCT00861757|141730589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.013|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|||||-0.1|-0.6|0.013
71111905|NCT00861757|141730589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.9|-0.4|||ANCOVA|||||-0.4|-0.9|<0.001
70852714|NCT01578850|141194334|SUPERIORITY_OR_OTHER||Difference in proportions|9.0||||0.047|TWO_SIDED|95.0|0.85|17.25|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Remission: Week 44||17.25|0.85|0.047
71028372|NCT01644500|141564133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.81|||<|0.001|TWO_SIDED|95.0|-1.24|-0.39||Treatment comparison of midday (2 hours post-prandial) meal.|Mixed Models Analysis|||||-0.39|-1.24|<0.001
71111906|NCT00861757|141730590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.201|TWO_SIDED|95.0|-1.0|0.2|||ANCOVA|||||0.2|-1.0|0.201
71111907|NCT00861757|141730590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.393|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||||0.3|-0.8|0.393
71111908|NCT00861757|141730590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.3||0.007|TWO_SIDED|95.0|-1.4|-0.2|||ANCOVA|||||-0.2|-1.4|0.007
71111909|NCT00861757|141730591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.5||0.331|TWO_SIDED|95.0|-1.6|0.5|||ANCOVA|||||0.5|-1.6|0.331
71111910|NCT00861757|141730591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.5||0.14|TWO_SIDED|95.0|-1.8|0.3|||ANCOVA|||||0.3|-1.8|0.140
71111911|NCT00861757|141730591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.94|TWO_SIDED|95.0|-1.1|1.0|||ANCOVA|||||1.0|-1.1|0.940
71111912|NCT00861757|141730592|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 2.5 mg Tadalafil) and 7 categories of the PGI-I.|Cochran-Mantel-Haenszel|||||||<0.001
71111913|NCT00861757|141730592|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 5.0 mg Tadalafil) and 7 categories of the PGI-I.|Cochran-Mantel-Haenszel|||||||<0.001
71111914|NCT00861757|141730592|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (placebo vs 0.2 mg Tamsulosin) and 7 categories of the PGI-I.|Cochran-Mantel-Haenszel|||||||<0.001
71111915|NCT00861757|141730593|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 2.5 mg Tadalafil) and 7 categories of the CGI-I.|Cochran-Mantel-Haenszel|||||||0.034
71111916|NCT00861757|141730593|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 5.0 mg Tadalafil) and 7 categories of the CGI-I.|Cochran-Mantel-Haenszel|||||||0.002
71111917|NCT00861757|141730593|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 0.2 mg Tamsulosin) and 7 categories of the CGI-I.|Cochran-Mantel-Haenszel|||||||0.001
71111918|NCT00861757|141730594|SUPERIORITY_OR_OTHER|||||||0.412||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.412
71111919|NCT00861757|141730594|SUPERIORITY_OR_OTHER|||||||0.083||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.083
71111920|NCT00861757|141730594|SUPERIORITY_OR_OTHER|||||||0.456||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.456
71028373|NCT01644500|141564133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.67|||<|0.001|TWO_SIDED|95.0|-1.0|-0.34||Treatment comparison for evening (pre-prandial) meal.|Mixed Models Analysis|||||-0.34|-1.00|<0.001
71028374|NCT01644500|141564133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.08||||0.638|TWO_SIDED|95.0|-0.41|0.25||Treatment comparison for evening (pre-prandial) meal.|Mixed Models Analysis|||||0.25|-0.41|0.638
71028375|NCT01644500|141564133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.27|||<|0.001|TWO_SIDED|95.0|-1.68|-0.87||Treatment comparison for evening (2 hours post-prandial) meal.|Mixed Models Analysis|||||-0.87|-1.68|<0.001
71111921|NCT00861757|141730595|SUPERIORITY_OR_OTHER|||||||0.688||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.688
71111922|NCT00861757|141730595|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.510
71111923|NCT00861757|141730595|SUPERIORITY_OR_OTHER|||||||0.212||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.212
71111924|NCT00861757|141730596|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||This is the p value for systolic blood pressure.|Wilcoxon (Mann-Whitney)|||||||0.005
71111925|NCT00861757|141730596|SUPERIORITY_OR_OTHER|||||||0.274||95.0||||This is the p value for systolic blood pressure.|Wilcoxon (Mann-Whitney)|||||||0.274
70938439|NCT02006641|141377039|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.08||1|TWO_SIDED|95.0|-0.23|0.1||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.||0.10|-0.23|1.000
70938440|NCT02006641|141377039|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.09||1|TWO_SIDED|95.0|-0.12|0.21||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.||0.21|-0.12|1.000
70938441|NCT01697956|141377063|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI for the geometric mean ratio of BDP nasal aerosol versus placebo was greater than 0.80.|ratio of BDP nasal aerosol to placebo|0.91|||||TWO_SIDED|95.0|0.81|1.03||||||The standard deviation of the logarithmically transformed data on the change from baseline (expressed as a ratio) in 24-hr serum cortisol weighted mean is assumed to be 0.30. Using this standard deviation, 90 subjects (approximately 60 and 30 subjects in the BDP Nasal Aerosol and placebo groups, respectively) will yield approximately 90% power to demonstrate non-inferiority between BDP Nasal Aerosol and placebo, if there is no true difference between treatment groups.||1.03|0.81|
70938442|NCT03293238|141377084|SUPERIORITY|||||||0.527|||||||ANOVA|||||||0.527
70938443|NCT03293238|141377085|SUPERIORITY|||||||0.749|||||||ANOVA|||||||0.749
70938444|NCT00866619|141377091|SUPERIORITY|Criterion for success = lower limit (LL) of 97.5% confidence interval (CI) of VE \> 0.|Vaccine efficacy|55.8|||<|0.0001|TWO_SIDED|97.5|50.6|60.4|||Regression, Cox|||The analysis aimed to compare RfoCPFMI between groups over the Months 2.5-14 time period. Using RfoCFPMI, a Cox regression model was used to evaluate vaccine efficacy (VE) allowing for adjustment by factors. VE was calculated as 1 minus \[Hazard Ratio (HR) in GSK257049 \[5-17M\] Group (HR1) divided by HR in control VeroRab Comparator \[5-17M\] Group (HR2)\]; i. e. 1 - (HR1/HR2).||60.4|50.6|<0.0001
70938445|NCT00866619|141377092|SUPERIORITY|Point estimate of efficacy was adjusted for study site as stratification factor for the analysis. Criterion for success = lower limit (LL) of 97.5% confidence interval (CI) of VE \> 0.|Vaccine efficacy|31.315|||<|0.0001|TWO_SIDED|97.5|23.556|38.286|||Regression, Cox|||The analysis aimed to compare RfoCPFMI between groups over the Months 2.5-14 time period. Using RfoCFPMI, a Cox regression model was used to evaluate vaccine efficacy (VE) allowing for adjustment by factors. VE was calculated as 1 minus \[Hazard Ratio (HR) in GSK257049 \[6-12W\] Group (HR1) divided by HR in control Menjugate Comparator \[6-12W\] Group (HR2)\]; i. e. 1 - (HR1/HR2).||38.286|23.556|<0.0001
71066384|NCT03850483|141641578|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.53||0.3331|TWO_SIDED|90.0|-1.12|0.65|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.65|-1.12|0.3331
70938446|NCT00645411|141377158|NON_INFERIORITY_OR_EQUIVALENCE|Cell derived vaccine was considered non-inferior to egg-derived vaccine in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV) was \>0.667.|Ratio of GMTs|0.85|||||TWO_SIDED|95.0|0.72|1.01|||ANOVA|||Non-inferiority of cTIV to eTIV against A/H1N1 influenza strain as measured by HI egg-derived antigen assay||1.01|0.72|
70938447|NCT00645411|141377158|NON_INFERIORITY_OR_EQUIVALENCE|Cell derived vaccine (cTIV ) was considered non-inferior to egg-derived vaccine (eTIV) in postvaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs(cTIV/eTIV) was \>0.667.|Ratio of GMTs|0.59|||||TWO_SIDED|95.0|0.49|0.72|||ANOVA|||Non-inferiority of cTIV to eTIV against A/H3N2 influenza strain as measured by HI egg-derived antigen assay.||0.72|0.49|
70938448|NCT00645411|141377158|NON_INFERIORITY_OR_EQUIVALENCE|Cell derived vaccine (cTIV ) was considered non-inferior to egg-derived vaccine (eTIV)in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV) was \>0.667.|Ratio of GMTs|0.56|||||TWO_SIDED|95.0|0.46|0.68|||ANOVA|||Non-inferiority of cTIV to eTIV against influenza B strain as measured by HI egg-derived antigen assay.||0.68|0.46|
70941785|NCT04748445|141383935|OTHER||Slope|0.0001989|STANDARD_ERROR_OF_MEAN|1.076||0.0668|TWO_SIDED|90.0|0.00002067|0.0003772|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0003772|0.00002067|0.0668
71066385|NCT03850483|141641578|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.51||0.108|TWO_SIDED|90.0|-1.47|0.21|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.21|-1.47|0.1080
71066386|NCT03850483|141641578|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.48||0.0455|TWO_SIDED|90.0|-1.61|-0.02|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.02|-1.61|0.0455
71111926|NCT00861757|141730596|SUPERIORITY_OR_OTHER|||||||0.538||95.0||||This is the p value for systolic blood pressure.|Wilcoxon (Mann-Whitney)|||||||0.538
71111927|NCT00861757|141730596|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||This is the p value for diastolic blood pressure.|Wilcoxon (Mann-Whitney)|||||||0.008
71111928|NCT00861757|141730596|SUPERIORITY_OR_OTHER|||||||0.216||95.0||||This is the p value for diastolic blood pressure.|Wilcoxon (Mann-Whitney)|||||||0.216
70938449|NCT00645411|141377158|NON_INFERIORITY_OR_EQUIVALENCE|Cell derived vaccine (cTIV) was considered non-inferior to egg-derived vaccine (eTIV) in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV) was \>0.667.|Ratio of GMTs|0.92|||||TWO_SIDED|95.0|0.79|1.08|||ANOVA|||Non-inferiority of cTIV to eTIV against A/H1N1 influenza strain as measured by HI cell-derived antigen assay.||1.08|0.79|
70938450|NCT00645411|141377158|NON_INFERIORITY_OR_EQUIVALENCE|Cell derived vaccine (cTIV) was considered non-inferior to egg-derived vaccine (eTIV)in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV) was \>0.667.|Ratio of GMTs|0.65|||||TWO_SIDED|95.0|0.54|0.78|||ANOVA|||Non-inferiority of cTIV to eTIV against A/H3N2 influenza strain as measured by HI cell-derived antigen assay.||0.78|0.54|
71066387|NCT03850483|141641578|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.48||0.0761|TWO_SIDED|90.0|-1.49|0.1|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.10|-1.49|0.0761
71066388|NCT03850483|141641578|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.5||0.0273|TWO_SIDED|90.0|-1.8|-0.14|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.14|-1.80|0.0273
71066389|NCT03850483|141641578|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.54||0.7214|TWO_SIDED|90.0|-0.57|1.2|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.20|-0.57|0.7214
71111929|NCT00861757|141730596|SUPERIORITY_OR_OTHER|||||||0.524||95.0||||This is the p value for diastolic blood pressure.|Wilcoxon (Mann-Whitney)|||||||0.524
71111930|NCT00861757|141730597|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||This is the p value for systolic blood pressure.|Wilcoxon rank-sum test|||||||0.007
71111931|NCT00861757|141730597|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||This is the p value for systolic blood pressure.|Wilcoxon rank-sum test|||||||0.723
70852715|NCT01578850|141194334|SUPERIORITY_OR_OTHER||Difference in proportions|12.1||||0.031|TWO_SIDED|95.0|3.7|20.57|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Remission: Week 52||20.57|3.70|0.031
71066390|NCT03850483|141641578|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.55||0.6132|TWO_SIDED|90.0|-0.75|1.06|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.06|-0.75|0.6132
71066391|NCT03850483|141641578|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.56||0.5704|TWO_SIDED|90.0|-0.83|1.02|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.02|-0.83|0.5704
71111932|NCT00861757|141730597|SUPERIORITY_OR_OTHER|||||||0.273||95.0||||This is the p value for systolic blood pressure.|Wilcoxon rank-sum test|||||||0.273
71111933|NCT00861757|141730597|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||This is the p value for diastolic blood pressure.|Wilcoxon rank-sum test|||||||0.005
71111934|NCT00861757|141730597|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||This is the p value for diastolic blood pressure.|Wilcoxon rank-sum test|||||||0.054
70938451|NCT00645411|141377158|NON_INFERIORITY_OR_EQUIVALENCE|Cell derived vaccine (cTIV) was considered non-inferior to egg-derived vaccine (eTIV)in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV)was \>0.667.|Ratio of GMTs|0.87|||||TWO_SIDED|95.0|0.71|1.06|||ANOVA|||Non-inferiority of cTIV to eTIV against B influenza strain as measured by HI cell-derived antigen assay.||1.06|0.71|
71066392|NCT03850483|141641578|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.53||0.3449|TWO_SIDED|90.0|-1.1|0.67|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.67|-1.10|0.3449
71111935|NCT00861757|141730597|SUPERIORITY_OR_OTHER|||||||0.278||95.0||||This is the p value for diastolic blood pressure.|Wilcoxon rank-sum test|||||||0.278
71111936|NCT00861757|141730598|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||Wilcoxon rank-sum test|||||||0.330
71111937|NCT00861757|141730598|SUPERIORITY_OR_OTHER|||||||0.838||95.0|||||Wilcoxon rank-sum test|||||||0.838
71111938|NCT00861757|141730598|SUPERIORITY_OR_OTHER|||||||0.409||95.0|||||Wilcoxon rank-sum test|||||||0.409
71111939|NCT01709110|141730610|SUPERIORITY||Odds Ratio (OR)|0.4071||||9.4e-05|TWO_SIDED|95.0|0.256|0.647|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.647|0.256|0.000094
71111940|NCT01709110|141730610|SUPERIORITY||Risk Ratio (RR)|0.4431||||9.4e-05|TWO_SIDED|95.0|0.29|0.677|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.677|0.290|0.000094
71111941|NCT01709110|141730611|SUPERIORITY||Odds Ratio (OR)|0.4187||||7.5e-05|TWO_SIDED|95.0|0.269|0.652|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.652|0.269|0.000075
71111942|NCT01709110|141730611|SUPERIORITY||Risk Ratio (RR)|0.4561||||7.5e-05|TWO_SIDED|95.0|0.305|0.682|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.682|0.305|0.000075
71111943|NCT01709110|141730612|SUPERIORITY||Stratified Hazard Ratio (HR)|0.4831||||0.000869|TWO_SIDED|95.0|0.316|0.739|||Stratified Log Rank|Stratified Log Rank test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.|The Stratified Hazard Ratio estimate and corresponding 95% CI were obtained from the number of observed and expected events as part of the stratified log-rank test calculations.|||0.739|0.316|0.000869
71111944|NCT01709110|141730613|SUPERIORITY||Stratified Hazard Ratio (HR)|0.6553||||0.099023|TWO_SIDED|95.0|0.39|1.101|||Stratified Log Rank|Stratified Log Rank test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.|The Stratified Hazard Ratio estimate and corresponding 95% CI were obtained from the number of observed and expected events as part of the stratified log-rank test calculations.|||1.101|0.390|0.099023
70938452|NCT00645411|141377159|NON_INFERIORITY_OR_EQUIVALENCE|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was \>-10%.|Difference in % (cTIV minus eTIV)|-1.0|||||TWO_SIDED|95.0|-4.0|1.0|||binomial or the method of Miettinen and|||Non-inferiority of cTIV to eTIV against A/H1N1 influenza strain as measured by HI egg-derived antigen assay.||1|-4|
70938453|NCT00645411|141377159|NON_INFERIORITY_OR_EQUIVALENCE|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was \>-10%.|Difference % (cTIV - eTIV)|-9.0|||||TWO_SIDED|95.0|-13.0|-4.0|||binomial or Miettinen & Nurimen method|||Non-inferiority of cTIV to eTIV against A/H3N2 influenza strain as measured by HI egg-derived antigen assay.||-4|-13|
70941786|NCT04748445|141383935|OTHER||Slope|0.00005573|STANDARD_ERROR_OF_MEAN|9.318||0.5509|TWO_SIDED|90.0|-0.0000986|0.0002101|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-5).||0.0002101|-0.0000986|0.5509
71066393|NCT03850483|141641578|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.58||0.0493|TWO_SIDED|90.0|-1.94|0.0|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.00|-1.94|0.0493
71066394|NCT03850483|141641578|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.57||0.149|TWO_SIDED|90.0|-1.55|0.35|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.35|-1.55|0.1490
71066395|NCT03850483|141641578|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.6||0.054|TWO_SIDED|90.0|-1.96|0.02|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.02|-1.96|0.0540
71066396|NCT03850483|141641578|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.61||0.3119|TWO_SIDED|90.0|-1.32|0.71|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.71|-1.32|0.3119
71066397|NCT03850483|141641578|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.62||0.3947|TWO_SIDED|90.0|-1.2|0.86|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.86|-1.20|0.3947
71066398|NCT03850483|141641578|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.64||0.4205|TWO_SIDED|90.0|-1.18|0.93|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.93|-1.18|0.4205
71111945|NCT01709110|141730614|SUPERIORITY||Stratified Hazard Ratio (HR)|0.5786||||0.062432|TWO_SIDED|95.0|0.318|1.052|||Stratified Log Rank|Stratified Log Rank test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.|The Stratified Hazard Ratio estimate and corresponding 95% CI were obtained from the number of observed and expected events as part of the stratified log-rank test calculations.|||1.052|0.318|0.062432
71111946|NCT01709110|141730615|SUPERIORITY||Odds Ratio (OR)|0.3812|||<|0.001|TWO_SIDED|95.0|0.237|0.614|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.614|0.237|<0.001
71111947|NCT01709110|141730615|SUPERIORITY||Risk Ratio (RR)|0.4173|||<|0.001|TWO_SIDED|95.0|0.27|0.646|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.646|0.270|<0.001
71111948|NCT01709110|141730616|SUPERIORITY||Odds Ratio (OR)|0.1593||||0.007|TWO_SIDED|95.0|0.035|0.728|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.728|0.035|0.007
71111949|NCT01709110|141730616|SUPERIORITY||Risk Ratio (RR)|0.1643||||0.007|TWO_SIDED|95.0|0.036|0.744|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.744|0.036|0.007
71066399|NCT03850483|141641578|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.6||0.0472|TWO_SIDED|90.0|-2.02|-0.02|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.02|-2.02|0.0472
71066400|NCT03850483|141641578|SUPERIORITY||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.59||0.0044|TWO_SIDED|90.0|-2.55|-0.6|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.60|-2.55|0.0044
71066401|NCT03850483|141641578|SUPERIORITY||LS mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.58||0.0098|TWO_SIDED|90.0|-2.32|-0.41|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.41|-2.32|0.0098
71066402|NCT03850483|141641578|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.61||0.1285|TWO_SIDED|90.0|-1.71|0.32|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.32|-1.71|0.1285
70938454|NCT00645411|141377159|NON_INFERIORITY_OR_EQUIVALENCE|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was \>-10%.|Difference % (cTIV minus eTIV)|-15.0|||||TWO_SIDED|95.0|-21.0|-9.0|||binominal or Miettinen &Nurimen method|||Non-inferiority of cTIV to eTIV against B influenza strain as measured by HI egg-derived antigen assay.||-9|-21|
70938455|NCT00645411|141377159|NON_INFERIORITY_OR_EQUIVALENCE|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was \>-10%|Difference % (cTIV minus eTIV)|-1.0|||||TWO_SIDED|95.0|-3.0|2.0|||binominal or Miettinen &Nurimen method|||Non-inferiority of cTIV to eTIV against A/H1N1 influenza strain as measured by HI cell-derived antigen assay.||2|-3|
70938456|NCT00645411|141377159|NON_INFERIORITY_OR_EQUIVALENCE|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was \>-10%.|Difference % (cTIV minus eTIV)|-5.0|||||TWO_SIDED|95.0|-9.5|0.0|||binominal or Miettinen &Nurimen method|||Non-inferiority of cTIV to eTIV against A/H3N2 influenza strain as measured by HI cell-derived antigen assay.||0|-9.5|
71066403|NCT03850483|141641578|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.6||0.3243|TWO_SIDED|90.0|-1.27|0.72|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.72|-1.27|0.3243
71066404|NCT03850483|141641578|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.61||0.3795|TWO_SIDED|90.0|-1.2|0.82|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.82|-1.20|0.3795
71066405|NCT03850483|141641578|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.62||0.307|TWO_SIDED|90.0|-1.35|0.72|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.72|-1.35|0.3070
71066406|NCT03850483|141641578|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.59||0.1014|TWO_SIDED|90.0|-1.74|0.22|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.22|-1.74|0.1014
71066407|NCT03850483|141641578|SUPERIORITY||LS mean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.62||0.0033|TWO_SIDED|90.0|-2.75|-0.69|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.69|-2.75|0.0033
71066408|NCT03850483|141641578|SUPERIORITY||LS mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.6||0.028|TWO_SIDED|90.0|-2.18|-0.17|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.17|-2.18|0.0280
71066409|NCT03850483|141641578|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.64||0.0781|TWO_SIDED|90.0|-1.98|0.15|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.15|-1.98|0.0781
71066410|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|-0.1||||0.4216|TWO_SIDED|90.0|-9.4|9.1|||Chan and Zhang method|||Week 1||9.1|-9.4|0.4216
71066411|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|-0.1||||0.4216|TWO_SIDED|90.0|-9.4|9.1|||Chan and Zhang method|||Week 1||9.1|-9.4|0.4216
71066412|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|-2.8||||0.7362|TWO_SIDED|90.0|-12.5|5.0|||Chan and Zhang method|||Week 1||5.0|-12.5|0.7362
71066413|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|-2.8||||0.7417|TWO_SIDED|90.0|-12.5|4.7|||Chan and Zhang method|||Week 1||4.7|-12.5|0.7417
71066414|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-5.9|8.0|||Chan and Zhang method|||Week 1||8.0|-5.9|0.5000
71066415|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|5.7||||0.0714|TWO_SIDED|90.0|-0.8|16.9|||Chan and Zhang method|||Week 1||16.9|-0.8|0.0714
71066416|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|5.3||||0.0813|TWO_SIDED|90.0|-1.1|15.7|||Chan and Zhang method|||Week 1||15.7|-1.1|0.0813
71066417|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|-2.8||||0.7417|TWO_SIDED|90.0|-12.5|4.7|||Chan and Zhang method|||Week 2||4.7|-12.5|0.7417
71066418|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|-2.8||||0.7417|TWO_SIDED|90.0|-12.5|4.7|||Chan and Zhang method|||Week 2||4.7|-12.5|0.7417
71066419|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-9.6|9.6|||Chan and Zhang method|||Week 2||9.6|-9.6|0.5000
71066420|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|-0.1||||0.4216|TWO_SIDED|90.0|-9.4|9.1|||Chan and Zhang method|||Week 2||9.1|-9.4|0.4216
71066421|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|-2.0||||0.6894|TWO_SIDED|90.0|-9.4|5.9|||Chan and Zhang method|||Week 2||5.9|-9.4|0.6894
71066422|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|3.7||||0.2518|TWO_SIDED|90.0|-4.2|14.3|||Chan and Zhang method|||Week 2||14.3|-4.2|0.2518
71066423|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|8.5||||0.0565|TWO_SIDED|90.0|-0.3|20.3|||Chan and Zhang method|||Week 2||20.3|-0.3|0.0565
71066424|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|-0.2||||0.4446|TWO_SIDED|90.0|-11.0|11.0|||Chan and Zhang method|||Week 4||11.0|-11.0|0.4446
71066425|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|-5.6||||0.9001|TWO_SIDED|90.0|-16.5|1.9|||Chan and Zhang method|||Week 4||1.9|-16.5|0.9001
71066426|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-11.0|11.0|||Chan and Zhang method|||Week 4||11.0|-11.0|0.5000
71066427|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|-0.2||||0.4446|TWO_SIDED|90.0|-11.0|11.0|||Chan and Zhang method|||Week 4||11.0|-11.0|0.4446
71028376|NCT01644500|141564133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.45||||0.03|TWO_SIDED|95.0|-0.85|-0.04||Treatment comparison for evening (2 hours post-prandial) meal.|Mixed Models Analysis|||||-0.04|-0.85|0.030
71028377|NCT01644500|141564133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.19|||<|0.001|TWO_SIDED|95.0|-1.56|-0.82||Treatment comparison for bedtime.|Mixed Models Analysis|||||-0.82|-1.56|<0.001
71028378|NCT01644500|141564133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.66|||<|0.001|TWO_SIDED|95.0|-1.03|-0.29||Treatment comparison for bedtime.|Mixed Models Analysis|||||-0.29|-1.03|<0.001
71028379|NCT01644500|141564134|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Treatment comparison for all hypoglycemic episodes.|Negative binomial regression model|||||||<0.001
71028380|NCT01644500|141564134|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Treatment comparison for all hypoglycemic episodes.|Negative binomial regression model|||||||<0.001
71028381|NCT01644500|141564134|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||||||Treatment comparison for nocturnal hypoglycemic episodes. Nocturnal hypoglycemic episodes are rounded off to 2 decimal places.|Negative binomial regression model|||||||0.008
71028382|NCT01644500|141564134|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||||||Treatment comparison for nocturnal hypoglycemic episodes. Nocturnal hypoglycemic episodes are rounded off to 2 decimal places.|Negative binomial regression model|||||||0.006
71028383|NCT01644500|141564135|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71028384|NCT01644500|141564135|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
71028385|NCT01644500|141564136|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|17.41|||<|0.001|TWO_SIDED|95.0|11.27|23.55|||ANCOVA|||Insulin HOMA2-%B||23.55|11.27|<0.001
71028386|NCT01644500|141564136|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.92||||0.012|TWO_SIDED|95.0|1.78|14.06|||ANCOVA|||Insulin HOMA2%B||14.06|1.78|0.012
71028387|NCT01644500|141564136|SUPERIORITY||Mean Difference (Net)|16.44|||<|0.001|TWO_SIDED|95.0|11.81|21.06|||ANCOVA|||C-Peptide-Based HOMA2-%B||21.06|11.81|<0.001
71028388|NCT01644500|141564136|SUPERIORITY||Mean Difference (Net)|9.99|||<|0.001|TWO_SIDED|95.0|5.36|14.62|||ANCOVA|||C-Peptide-Based HOMA2-%B||14.62|5.36|<0.001
71028389|NCT01644500|141564137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.34||||0.913|TWO_SIDED|95.0|-5.83|6.51|||ANCOVA|||Insulin-Based HOMA2%S||6.51|-5.83|0.913
71028390|NCT01644500|141564137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-3.14||||0.318|TWO_SIDED|95.0|-9.3|3.03|||ANCOVA|||Insulin-Based HOMA2%S||3.03|-9.30|0.318
71028391|NCT01644500|141564137|SUPERIORITY||Mean Difference (Net)|-1.39||||0.576|TWO_SIDED|95.0|-6.27|3.49|||ANCOVA|||C-Peptide-Based HOMA2-%S||3.49|-6.27|0.576
71028392|NCT01644500|141564137|SUPERIORITY||Mean Difference (Net)|-6.79||||0.007|TWO_SIDED|95.0|-11.68|-1.89|||ANCOVA|||C-Peptide-Based HOMA2-%S||-1.89|-11.68|0.007
71028393|NCT01644500|141564140|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18||||||Treatment comparison for SBP.|Mixed Models Analysis|||||||0.180
71028394|NCT01644500|141564140|SUPERIORITY_OR_OTHER_LEGACY|||||||0.245||||||Treatment comparison for SBP.|Mixed Models Analysis|||||||0.245
71028395|NCT01644500|141564140|SUPERIORITY_OR_OTHER_LEGACY|||||||0.717||||||Treatment comparison for DBP.|Mixed Models Analysis|||||||0.717
71028396|NCT01644500|141564140|SUPERIORITY_OR_OTHER_LEGACY|||||||0.619||||||Treatment comparison for DBP.|Mixed Models Analysis|||||||0.619
71028397|NCT01644500|141564141|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71028398|NCT01644500|141564141|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035|||||||Mixed Models Analysis|||||||0.035
71028399|NCT01644500|141564144|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71028400|NCT01644500|141564144|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71028401|NCT01644500|141564145|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71028402|NCT01644500|141564145|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71028403|NCT00721409|141564190|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.488||||0.0004|TWO_SIDED|95.0|0.319|0.748||1-sided p-value from the log-rank test stratified by stratification factors per randomization and Part.|Log Rank|||The primary hypothesis to be tested was H0: λ=1 versus. HA: λ\<1, where λ was the palbociclib plus letrozole:letrozole alone hazard ratio (HR). A HR less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Letrozole. Stratified analysis was presented above.||0.748|0.319|0.0004
71028404|NCT00721409|141564190|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.299|||<|0.0001|TWO_SIDED|95.0|0.156|0.572||1-sided p-value from the log-rank test.|Log Rank|||The primary hypothesis to be tested was H0: λ=1 versus. HA: λ\<1, where λ was the palbociclib plus letrozole:letrozole alone hazard ratio (HR). A HR less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Letrozole. Unstratified analysis was presented above.||0.572|0.156|<0.0001
71028405|NCT00721409|141564190|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.508||||0.0046|TWO_SIDED|95.0|0.303|0.853||1-sided p-value from the log-rank test.|Log Rank|||The primary hypothesis to be tested was H0: λ=1 versus. HA: λ\<1, where λ was the palbociclib plus letrozole:letrozole alone hazard ratio (HR). A HR less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Letrozole. Unstratified analysis was presented above.||0.853|0.303|0.0046
71028406|NCT00721409|141564203|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.897||||0.2812|TWO_SIDED|95.0|0.623|1.294||1-sided p-value from the log-rank test stratified by Part (α = 0.10).|Log Rank|||Stratified analysis was presented above. Hazard ratio was assuming proportional hazards, a hazard ratio less than 1 indicated a reduction in hazard rate in favor of palbociclib + letrozole.||1.294|0.623|0.2812
71028407|NCT00721409|141564203|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.837||||0.2803|TWO_SIDED|95.0|0.458|1.527||1-sided p-value from the unstratified log-rank test (α=0.10).|Log Rank|||Unstratified analysis was presented above.||1.527|0.458|0.2803
71028408|NCT00721409|141564203|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.935||||0.3875|TWO_SIDED|95.0|0.59|1.48||1-sided p-value from the unstratified log-rank test (α=0.10).|Log Rank|||Unstratified analysis was presented above.||1.480|0.590|0.3875
71028409|NCT00721409|141564204|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.5||||0.1347|TWO_SIDED|95.0|0.76|2.97||1-sided p-value is from the stratified exact test (1-sided, α =0.10)|Cochran-Mantel-Haenszel|||Objective Response CI was calculated using the exact Clopper-Pearson method. The stratified analysis presented above was based on CMH test stratified by Part. An Odds Ratio \>1 means better response in favor of palbociclib + letrozole arm.||2.97|0.76|0.1347
71066428|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|0.2||||0.5054|TWO_SIDED|90.0|-10.5|12.5|||Chan and Zhang method|||Week 4||12.5|-10.5|0.5054
71066429|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|3.3||||0.3401|TWO_SIDED|90.0|-8.2|16.9|||Chan and Zhang method|||Week 4||16.9|-8.2|0.3401
71066430|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|12.9||||0.0489|TWO_SIDED|90.0|0.1|27.5|||Chan and Zhang method|||Week 4||27.5|0.1|0.0489
71066431|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|-2.9||||0.6349|TWO_SIDED|90.0|-14.8|8.4|||Chan and Zhang method|||Week 6||8.4|-14.8|0.6349
71111950|NCT01709110|141730617|SUPERIORITY||Stratified Hazard Ratio (HR)|0.696||||0.078|TWO_SIDED|95.0|0.461|1.05|||Stratified Log Rank|Stratified Log Rank test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.|The Stratified Hazard Ratio estimates and corresponding 95% CI were obtained from the number of observed and expected events as part of the stratified log-rank test calculations.|||1.050|0.461|0.078
71111951|NCT01709110|141730618|SUPERIORITY||Least Squares Mean|-0.13|STANDARD_ERROR_OF_MEAN|0.08||0.093|TWO_SIDED|95.0|-0.28|0.02||Model included the following fixed effects: treatment, visit, treatment-by-visit interaction, antecedent of recent clinical vertebral fractures, recent use of bisphosphonate and baseline body height(cm).|Mixed Models Analysis|An unstructured covariance matrix was assumed to account for the correlation between observations of the same participant.|Treatment difference was calculated as Teriparatide - Risedronate.|||0.02|-0.28|0.093
71111952|NCT01709110|141730619|SUPERIORITY||Least Squares Mean|-0.09|STANDARD_ERROR_OF_MEAN|0.17||0.585|TWO_SIDED|95.0|-0.42|0.24||Model included the following fixed effects: treatment, visit, treatment-by-visit interaction, antecedent of recent clinical vertebral fractures, recent use of bisphosphonate and baseline back pain (no pain - worst pain \[0-10\]).|Mixed Models Analysis|An unstructured covariance matrix was assumed to account for the correlation between observations of the same participant.|Treatment difference was calculated as Teriparatide - Risedronate.|||0.24|-0.42|0.585
71111953|NCT01709110|141730620|SUPERIORITY||Least Squares Mean|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.757|TWO_SIDED|95.0|-0.03|0.02||Model included the following fixed effects: treatment, visit, treatment-by-visit interaction, antecedent of recent clinical vertebral fractures, recent use of bisphosphonate baseline EQ-5D-5L (UK).|Mixed Models Analysis|An unstructured covariance matrix was assumed to account for the correlation between observations of the same participant.|Treatment difference was calculated as Teriparatide - Risedronate.|||0.02|-0.03|0.757
71066432|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|-5.6||||0.8253|TWO_SIDED|90.0|-17.2|4.4|||Chan and Zhang method|||Week 6||4.4|-17.2|0.8253
71111954|NCT01709110|141730621|SUPERIORITY||Least Squares Mean|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.694|TWO_SIDED|95.0|-0.02|0.01||Model included the following fixed effects: treatment, visit, treatment-by-visit interaction, antecedent of recent clinical vertebral fractures, recent use of bisphosphonate baseline EQ-5D-5L (US).|Mixed Models Analysis|An unstructured covariance matrix was assumed to account for the correlation between observations of the same participant.|Treatment difference was calculated as Teriparatide - Risedronate.|||0.01|-0.02|0.694
71111955|NCT03332173|141730622|SUPERIORITY||||||<|0.0001||||||P value was based on the exact binomial test against the null hypothesis H0: MRR = 0.30 at a significance level of 0.025 (1-sided)|Exact binomial test|||Zanubrutinib versus historical control estimate of 30%||||<0.0001
71066433|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-12.5|12.5|||Chan and Zhang method|||Week 6||12.5|-12.5|0.5000
71066434|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|5.2||||0.2709|TWO_SIDED|90.0|-8.3|19.1|||Chan and Zhang method|||Week 6||19.1|-8.3|0.2709
71066435|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|0.2||||0.5054|TWO_SIDED|90.0|-10.5|12.5|||Chan and Zhang method|||Week 6||12.5|-10.5|0.5054
71066436|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|-2.4||||0.6319|TWO_SIDED|90.0|-12.9|9.3|||Chan and Zhang method|||Week 6||9.3|-12.9|0.6319
71111956|NCT00910910|141730637|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.323|TWO_SIDED|90.0|0.88|1.66|||stratified log rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|Stratification factors: Disease stage (Binet A or Binet B or Rai I or Rai II versus (VS) Binet C or Rai III or Rai IV); Presence of at least one of the co-morbidities Asparate transaminase (AST)/Alanine transaminase (ALT) ≥ 3.0 times Upper Limits of Normal (ULN,) Creatinine clearance ≥ 30 to \< 60 mL/min, Yes VS No); Presence of at least one 11q deletion, 17p deletion, unmutated Immunoglobulin Heavy-chain Variable-region (IgVH) or Beta-2 Microglobulin (ß2M )\> 4.0 mg/L (Yes versus No VS Unknown)||1.66|0.88|0.323
71066437|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|5.0||||0.3199|TWO_SIDED|90.0|-6.4|18.1|||Chan and Zhang method|||Week 6||18.1|-6.4|0.3199
71117669|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
71117670|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
71066438|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|-5.7||||0.7306|TWO_SIDED|90.0|-19.1|6.1|||Chan and Zhang method|||Week 8||6.1|-19.1|0.7306
71066439|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|-5.7||||0.7306|TWO_SIDED|90.0|-19.1|6.1|||Chan and Zhang method|||Week 8||6.1|-19.1|0.7306
71066440|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|-8.3||||0.8808|TWO_SIDED|90.0|-20.6|2.7|||Chan and Zhang method|||Week 8||2.7|-20.6|0.8808
71066441|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|-0.3||||0.4644|TWO_SIDED|90.0|-13.7|13.7|||Chan and Zhang method|||Week 8||13.7|-13.7|0.4644
71066442|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|7.8||||0.1534|TWO_SIDED|90.0|-3.4|20.9|||Chan and Zhang method|||Week 8||20.9|-3.4|0.1534
71066443|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|-0.4||||0.4867|TWO_SIDED|90.0|-10.0|11.4|||Chan and Zhang method|||Week 8||11.4|-10.0|0.4867
71066444|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|12.3||||0.0435|TWO_SIDED|90.0|0.4|25.9|||Chan and Zhang method|||Week 8||25.9|0.4|0.0435
71066445|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|-2.9||||0.6349|TWO_SIDED|90.0|-14.8|8.4|||Chan and Zhang method|||Week 10||8.4|-14.8|0.6349
71066446|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|-0.2||||0.4565|TWO_SIDED|90.0|-12.6|12.5|||Chan and Zhang method|||Week 10||12.5|-12.6|0.4565
71066447|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-12.5|12.5|||Chan and Zhang method|||Week 10||12.5|-12.5|0.5000
71066448|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|7.9||||0.1765|TWO_SIDED|90.0|-5.7|21.8|||Chan and Zhang method|||Week 10||21.8|-5.7|0.1765
71066449|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|0.3||||0.5013|TWO_SIDED|90.0|-14.0|15.2|||Chan and Zhang method|||Week 10||15.2|-14.0|0.5013
71066450|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|-7.8||||0.7969|TWO_SIDED|90.0|-20.7|5.9|||Chan and Zhang method|||Week 10||5.9|-20.7|0.7969
71066451|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|-3.2||||0.6424|TWO_SIDED|90.0|-16.4|10.6|||Chan and Zhang method|||Week 10||10.6|-16.4|0.6424
71066452|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|10.7||||0.062|TWO_SIDED|90.0|-0.7|23.6|||Chan and Zhang method|||Week 14||23.6|-0.7|0.0620
71066453|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|2.8||||0.3402|TWO_SIDED|90.0|-7.0|13.4|||Chan and Zhang method|||Week 14||13.4|-7.0|0.3402
71066454|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|5.8||||0.1743|TWO_SIDED|90.0|-4.5|17.6|||Chan and Zhang method|||Week 14||17.6|-4.5|0.1743
71066455|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|10.7||||0.062|TWO_SIDED|90.0|-0.7|23.6|||Chan and Zhang method|||Week 14||23.6|-0.7|0.0620
71066456|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|2.6||||0.3534|TWO_SIDED|90.0|-7.8|15.4|||Chan and Zhang method|||Week 14||15.4|-7.8|0.3534
71066457|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|5.5||||0.2508|TWO_SIDED|90.0|-5.5|18.8|||Chan and Zhang method|||Week 14||18.8|-5.5|0.2508
71066458|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|1.9||||0.4238|TWO_SIDED|90.0|-8.2|13.6|||Chan and Zhang method|||Week 14||13.6|-8.2|0.4238
71066459|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|5.9||||0.2696|TWO_SIDED|90.0|-6.2|19.3|||Chan and Zhang method|||Week 16||19.3|-6.2|0.2696
71066460|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|3.0||||0.3648|TWO_SIDED|90.0|-8.6|15.3|||Chan and Zhang method|||Week 16||15.3|-8.6|0.3648
71066461|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|8.7||||0.1267|TWO_SIDED|90.0|-3.8|22.2|||Chan and Zhang method|||Week 16||22.2|-3.8|0.1267
71066462|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|10.7||||0.0832|TWO_SIDED|90.0|-2.5|24.4|||Chan and Zhang method|||Week 16||24.4|-2.5|0.0832
71066463|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|6.5||||0.2099|TWO_SIDED|90.0|-5.7|21.3|||Chan and Zhang method|||Week 16||21.3|-5.7|0.2099
71066464|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|3.6||||0.3474|TWO_SIDED|90.0|-8.0|17.4|||Chan and Zhang method|||Week 16||17.4|-8.0|0.3474
71066465|NCT03850483|141641582|SUPERIORITY||Risk Difference (RD)|8.1||||0.2124|TWO_SIDED|90.0|-4.0|21.6|||Chan and Zhang method|||Week 16||21.6|-4.0|0.2124
71066466|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|13.7||||0.0544|TWO_SIDED|90.0|-0.3|27.9|||Chan and Zhang method|||Week 1||27.9|-0.3|0.0544
71066467|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|6.1||||0.2697|TWO_SIDED|90.0|-6.3|19.6|||Chan and Zhang method|||Week 1||19.6|-6.3|0.2697
71066468|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|16.5||||0.0286|TWO_SIDED|90.0|2.0|31.0|||Chan and Zhang method|||Week 1||31.0|2.0|0.0286
71066469|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|7.8||||0.1512|TWO_SIDED|90.0|-4.7|20.8|||Chan and Zhang method|||Week 1||20.8|-4.7|0.1512
71066470|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|-7.7||||0.79|TWO_SIDED|90.0|-21.9|7.4|||Chan and Zhang method|||Week 1||7.4|-21.9|0.7900
71066471|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|7.3||||0.3137|TWO_SIDED|90.0|-8.5|24.0|||Chan and Zhang method|||Week 1||24.0|-8.5|0.3137
71066472|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|5.0||||0.3789|TWO_SIDED|90.0|-10.9|22.6|||Chan and Zhang method|||Week 1||22.6|-10.9|0.3789
71066473|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|13.7||||0.0636|TWO_SIDED|90.0|-1.0|28.5|||Chan and Zhang method|||Week 2||28.5|-1.0|0.0636
71066474|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|9.6||||0.1435|TWO_SIDED|90.0|-4.9|24.5|||Chan and Zhang method|||Week 2||24.5|-4.9|0.1435
71066475|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|25.7||||0.0058|TWO_SIDED|90.0|8.9|42.4|||Chan and Zhang method|||Week 2||42.4|8.9|0.0058
71066476|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|22.9||||0.0112|TWO_SIDED|90.0|6.5|38.9|||Chan and Zhang method|||Week 2||38.9|6.5|0.0112
71066477|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|4.9||||0.3349|TWO_SIDED|90.0|-10.8|21.3|||Chan and Zhang method|||Week 2||21.3|-10.8|0.3349
71066478|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|10.6||||0.2065|TWO_SIDED|90.0|-6.1|27.7|||Chan and Zhang method|||Week 2||27.7|-6.1|0.2065
71066479|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|11.4||||0.1871|TWO_SIDED|90.0|-5.6|29.1|||Chan and Zhang method|||Week 2||29.1|-5.6|0.1871
71066480|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|13.4||||0.1245|TWO_SIDED|90.0|-4.9|31.4|||Chan and Zhang method|||Week 4||31.4|-4.9|0.1245
71066481|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|14.0||||0.128|TWO_SIDED|90.0|-4.7|33.7|||Chan and Zhang method|||Week 4||33.7|-4.7|0.1280
71066482|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|32.9||||0.003|TWO_SIDED|90.0|12.4|50.5|||Chan and Zhang method|||Week 4||50.5|12.4|0.0030
70941787|NCT04748445|141383935|OTHER||Slope|0.00001774|STANDARD_ERROR_OF_MEAN|8.677||0.8383|TWO_SIDED|90.0|-0.000126|0.0001615|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-5).||0.0001615|-0.0001260|0.8383
71066483|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|22.6||||0.0235|TWO_SIDED|90.0|3.1|40.6|||Chan and Zhang method|||Week 4||40.6|3.1|0.0235
71066484|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|4.9||||0.3728|TWO_SIDED|90.0|-13.6|24.1|||Chan and Zhang method|||Week 4||24.1|-13.6|0.3728
71066485|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|25.5||||0.0153|TWO_SIDED|90.0|4.0|43.6|||Chan and Zhang method|||Week 4||43.6|4.0|0.0153
71066486|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|9.4||||0.2543|TWO_SIDED|90.0|-8.8|27.8|||Chan and Zhang method|||Week 4||27.8|-8.8|0.2543
71066487|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|7.9||||0.2785|TWO_SIDED|90.0|-10.2|26.4|||Chan and Zhang method|||Week 6||26.4|-10.2|0.2785
71066488|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|13.3||||0.1434|TWO_SIDED|90.0|-7.4|33.7|||Chan and Zhang method|||Week 6||33.7|-7.4|0.1434
71066489|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|36.1||||0.0015|TWO_SIDED|90.0|12.8|54.1|||Chan and Zhang method|||Week 6||54.1|12.8|0.0015
71066490|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|24.1||||0.0242|TWO_SIDED|90.0|3.4|43.9|||Chan and Zhang method|||Week 6||43.9|3.4|0.0242
71066491|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|35.1||||0.0037|TWO_SIDED|90.0|10.0|54.1|||Chan and Zhang method|||Week 6||54.1|10.0|0.0037
71066492|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|16.6||||0.1037|TWO_SIDED|90.0|-4.9|36.7|||Chan and Zhang method|||Week 6||36.7|-4.9|0.1037
71066493|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|1.8||||0.4607|TWO_SIDED|90.0|-17.7|22.5|||Chan and Zhang method|||Week 6||22.5|-17.7|0.4607
71066494|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|12.2||||0.1725|TWO_SIDED|90.0|-8.0|31.9|||Chan and Zhang method|||Week 8||31.9|-8.0|0.1725
71111957|NCT00910910|141730638|SUPERIORITY||Cox Proportional Hazard|0.99||||0.967|TWO_SIDED|90.0|0.76|1.29||The p-value is based on a stratified log-rank test|Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|Stratification factors: Disease stage (Binet A or Binet B or Rai I or Rai II versus (VS) Binet C or Rai III or Rai IV); Presence of at least one of the co-morbidities Asparate transaminase (AST)/Alanine transaminase (ALT) ≥ 3.0 times Upper Limits of Normal (ULN,) Creatinine clearance ≥ 30 to \< 60 mL/min, Yes VS No); Presence of at least one 11q deletion, 17p deletion, unmutated Immunoglobulin Heavy-chain Variable-region (IgVH) or Beta-2 Microglobulin (ß2M )\> 4.0 mg/L (Yes versus No VS Unknown)||1.29|0.76|0.967
71066495|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|22.8||||0.0451|TWO_SIDED|90.0|0.2|43.6|||Chan and Zhang method|||Week 8||43.6|0.2|0.0451
71066496|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|44.4||||0.0003|TWO_SIDED|90.0|21.3|62.9|||Chan and Zhang method|||Week 8||62.9|21.3|0.0003
71066497|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|26.7||||0.0239|TWO_SIDED|90.0|3.8|47.6|||Chan and Zhang method|||Week 8||47.6|3.8|0.0239
71066498|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|20.8||||0.0643|TWO_SIDED|90.0|-2.1|41.2|||Chan and Zhang method|||Week 8||41.2|-2.1|0.0643
71066499|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|-6.0||||0.6676|TWO_SIDED|90.0|-25.9|15.9|||Chan and Zhang method|||Week 8||15.9|-25.9|0.6676
71066500|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|17.6||||0.0898|TWO_SIDED|90.0|-4.2|37.8|||Chan and Zhang method|||Week 8||37.8|-4.2|0.0898
71066501|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|11.8||||0.2707|TWO_SIDED|90.0|-10.1|32.9|||Chan and Zhang method|||Week 10||32.9|-10.1|0.2707
71066502|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|9.0||||0.2981|TWO_SIDED|90.0|-14.2|31.0|||Chan and Zhang method|||Week 10||31.0|-14.2|0.2981
71066503|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|31.0||||0.011|TWO_SIDED|90.0|8.0|51.4|||Chan and Zhang method|||Week 10||51.4|8.0|0.0110
71066504|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|33.3||||0.0083|TWO_SIDED|90.0|9.1|53.2|||Chan and Zhang method|||Week 10||53.2|9.1|0.0083
71066505|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|4.8||||0.4217|TWO_SIDED|90.0|-18.3|27.5|||Chan and Zhang method|||Week 10||27.5|-18.3|0.4217
71066506|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|1.3||||0.5152|TWO_SIDED|90.0|-20.8|23.2|||Chan and Zhang method|||Week 10||23.2|-20.8|0.5152
71066507|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|-11.8||||0.7002|TWO_SIDED|90.0|-33.1|11.7|||Chan and Zhang method|||Week 10||11.7|-33.1|0.7002
71066508|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|27.6||||0.0169|TWO_SIDED|90.0|5.2|47.9|||Chan and Zhang method|||Week 12||47.9|5.2|0.0169
71066509|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|25.9||||0.0283|TWO_SIDED|90.0|3.2|46.2|||Chan and Zhang method|||Week 12||46.2|3.2|0.0283
71066510|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|37.9||||0.002|TWO_SIDED|90.0|14.3|57.1|||Chan and Zhang method|||Week 12||57.1|14.3|0.0020
71066511|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|31.4||||0.0095|TWO_SIDED|90.0|8.4|51.5|||Chan and Zhang method|||Week 12||51.5|8.4|0.0095
71066512|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|21.0||||0.0798|TWO_SIDED|90.0|-2.7|42.6|||Chan and Zhang method|||Week 12||42.6|-2.7|0.0798
71066513|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|10.9||||0.2848|TWO_SIDED|90.0|-11.3|31.8|||Chan and Zhang method|||Week 12||31.8|-11.3|0.2848
71066514|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|0.5||||0.5062|TWO_SIDED|90.0|-21.1|23.1|||Chan and Zhang method|||Week 12||23.1|-21.1|0.5062
71066515|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|36.9||||0.0012|TWO_SIDED|90.0|16.7|55.3|||Chan and Zhang method|||Week 14||55.3|16.7|0.0012
71066516|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|38.7||||0.0007|TWO_SIDED|90.0|17.3|57.4|||Chan and Zhang method|||Week 14||57.4|17.3|0.0007
71066517|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|47.0||||0.0001|TWO_SIDED|90.0|24.6|65.1|||Chan and Zhang method|||Week 14||65.1|24.6|0.0001
71066518|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|29.9||||0.0039|TWO_SIDED|90.0|9.5|48.7|||Chan and Zhang method|||Week 14||48.7|9.5|0.0039
71066519|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|4.5||||0.3895|TWO_SIDED|90.0|-17.5|26.5|||Chan and Zhang method|||Week 14||26.5|-17.5|0.3895
71066520|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|10.1||||0.2793|TWO_SIDED|90.0|-11.8|31.8|||Chan and Zhang method|||Week 14||31.8|-11.8|0.2793
71066521|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|-8.5||||0.7027|TWO_SIDED|90.0|-28.4|12.2|||Chan and Zhang method|||Week 14||12.2|-28.4|0.7027
71066522|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|37.0||||0.0009|TWO_SIDED|90.0|15.4|55.2|||Chan and Zhang method|||Week 16||55.2|15.4|0.0009
71066523|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|23.0||||0.0205|TWO_SIDED|90.0|4.1|43.2|||Chan and Zhang method|||Week 16||43.2|4.1|0.0205
71066524|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|46.8||||0.0001|TWO_SIDED|90.0|24.6|65.7|||Chan and Zhang method|||Week 16||65.7|24.6|0.0001
71066525|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|44.6||||0.0002|TWO_SIDED|90.0|21.5|62.9|||Chan and Zhang method|||Week 16||62.9|21.5|0.0002
71066526|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|-18.5||||0.9209|TWO_SIDED|90.0|-38.3|3.2|||Chan and Zhang method|||Week 16||3.2|-38.3|0.9209
71066527|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|-13.9||||0.793|TWO_SIDED|90.0|-34.4|8.7|||Chan and Zhang method|||Week 16||8.7|-34.4|0.7930
71066528|NCT03850483|141641583|SUPERIORITY||Risk Difference (RD)|-5.1||||0.6156|TWO_SIDED|90.0|-28.0|20.1|||Chan and Zhang method|||Week 16||20.1|-28.0|0.6156
71066529|NCT03018080|141641685|OTHER|Estimation only.|Rate|0.238|||||TWO_SIDED|95.0|0.082|0.472|||||Confidence interval estimated using the Clopper Pearson method.|The reported grade 3/4 toxicity rate with weekly paclitaxel was 0.35. If it became evident that the grade 3/4 treatment-related toxicity rate on either arm convincingly exceeded 0.35, the study arm would have been halted. Convincing evidence of exceeding 0.35 was based on Bayesian methods and continuous monitoring, where the stopping rule would have held enrollment if the posterior probability at any point exceeded 0.50 or higher.||0.472|0.082|
71066530|NCT03018080|141641685|OTHER|Estimation only.|Rate|0.316|||||TWO_SIDED|95.0|0.126|0.566|||||Confidence interval estimated using the Clopper Pearson method.|The reported grade 3/4 toxicity rate with weekly paclitaxel was 0.35. If it became evident that the grade 3/4 treatment-related toxicity rate on either arm convincingly exceeded 0.35, the study arm would have been halted. Convincing evidence of exceeding 0.35 was based on Bayesian methods and continuous monitoring, where the stopping rule would have held enrollment if the posterior probability at any point exceeded 0.50 or higher.||0.566|0.126|
71066531|NCT03018080|141641686|OTHER|Estimation only|Rate|0.191|||||TWO_SIDED|95.0|0.055|0.419|||||Confidence interval estimated using the Clopper Pearson method.|||0.419|0.055|
70938457|NCT00645411|141377159|NON_INFERIORITY_OR_EQUIVALENCE|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was \>-10%.|Difference % (cTIV minus eTIV)|0.0|||||TWO_SIDED|95.0|-6.0|6.0|||binominal or Miettinen &Nurimen method|||Non-inferiority of cTIV to eTIV against B influenza strain as measured by HI cell-derived antigen assay.||6|-6|
71066532|NCT03018080|141641686|OTHER|Estimation only.|Rate|0.421|||||TWO_SIDED|95.0|0.203|0.665|||||Confidence interval estimated using the Clopper Pearson method|||0.665|0.203|
71066533|NCT03018080|141641687|OTHER|Estimation only|Median|4.1|||||TWO_SIDED|95.0|1.4|6.9|||||The Kaplan Meier method was used to estimate the median PFS(in months) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||6.9|1.4|
71066534|NCT03018080|141641687|OTHER|Estimation only|Median|3.9|||||TWO_SIDED|95.0|1.4|6.8|||||The Kaplan Meier method was used to estimate the median PFS(in months) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||6.8|1.4|
71066535|NCT03018080|141641688|OTHER|Estimation only|Median|27.6|||||TWO_SIDED|95.0|9.7||Upper limit of the confidence interval is not reached due to censoring rate||||The Kaplan Meier method was used to estimate median OS (in months). The Greenwood method was used to estimate confidence limits of median overall survival.||||9.7|
71066536|NCT03018080|141641688|OTHER|Estimation only|Median|9.0|||||TWO_SIDED|95.0|6.8|14.0|||||The Kaplan Meier method was used to estimate median OS (in months). The Greenwood method was used to estimate confidence limits of median overall survival.|||14.0|6.8|
71066537|NCT03018080|141641689|OTHER|Estimation only.|Rate|0.667|||||TWO_SIDED|95.0|0.43|0.854|||||Confidence interval estimated using the Clopper Pearson method|||0.854|0.430|
71111958|NCT00910910|141730641|SUPERIORITY||Odds Ratio (OR)|0.65||||0.032|TWO_SIDED|95.0|0.44|0.96|||Fisher Exact|||||0.96|0.44|0.032
71066538|NCT03018080|141641689|OTHER|Estimation only|Rate|0.632|||||TWO_SIDED|95.0|0.384|0.837|||||Confidence interval estimated using the Clopper Pearson method|||0.837|0.384|
71066539|NCT03018080|141641690|OTHER|Estimation only|Median|7.3|||||TWO_SIDED|95.0|5.6|8.3|||||"The Kaplan Meier method was used to estimate median duration of response (in months).~The Greenwood method was used to estimate confidence limits of median duration of response."|||8.3|5.6|
71066540|NCT03018080|141641690|OTHER|Estimation only|Median|4.0|||||TWO_SIDED|95.0|2.6|8.3|||||"The Kaplan Meier method was used to estimate median duration of response (in months).~The Greenwood method was used to estimate confidence limits of median duration of response."|||8.3|2.6|
71066541|NCT01019694|141641692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.6|||<|0.0001||95.0|6.02|13.19|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||13.19|6.02|< 0.0001
71066542|NCT01019694|141641692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2||||0.0009||95.0|2.57|9.91|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||9.91|2.57|0.0009
71066543|NCT01019694|141641693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3||||0.0006||95.0|2.29|8.28|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||8.28|2.29|0.0006
71111959|NCT00910910|141730642|SUPERIORITY||Odds Ratio (OR)|0.66||||0.047|TWO_SIDED|95.0|0.45|0.98|||Fisher Exact|||||0.98|0.45|0.047
71066544|NCT01019694|141641693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.4|||<|0.0001||95.0|4.41|10.39|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||10.39|4.41|< 0.0001
71066545|NCT01019694|141641694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9|||<|0.0001||95.0|4.71|11.09|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||11.09|4.71|< 0.0001
71066546|NCT01019694|141641694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.6|||<|0.0001||95.0|6.44|12.83|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||12.83|6.44|< 0.0001
71066547|NCT01019694|141641695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.2|||<|0.0001||95.0|5.94|12.37|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||12.37|5.94|< 0.0001
71066548|NCT01019694|141641695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.7|||<|0.0001||95.0|4.44|10.96|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||10.96|4.44|< 0.0001
71066549|NCT01019694|141641696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.3|||<|0.0001||95.0|7.9|14.76|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||14.76|7.90|< 0.0001
71066550|NCT01019694|141641696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.7|||<|0.0001||95.0|4.23|11.23|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||11.23|4.23|< 0.0001
71066551|NCT01019694|141641698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.1167||95.0|-0.05|0.42|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.42|-0.05|0.1167
71066552|NCT01019694|141641698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.0026||95.0|0.13|0.59|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.59|0.13|0.0026
71066553|NCT01019694|141641699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.2826||95.0|-0.11|0.38|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.38|-0.11|0.2826
71066554|NCT01019694|141641699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.0013||95.0|0.16|0.66|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.66|0.16|0.0013
71066555|NCT01019694|141641700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.0023||95.0|0.13|0.59|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.59|0.13|0.0023
71066556|NCT01019694|141641700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||<|0.0001||95.0|0.25|0.71|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.71|0.25|< 0.0001
71066557|NCT01019694|141641701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.0006||95.0|0.18|0.65|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.65|0.18|0.0006
71066558|NCT01019694|141641701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.0004||95.0|0.2|0.68|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.68|0.20|0.0004
71066559|NCT01019694|141641702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.0673||95.0|-0.02|0.47|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.47|-0.02|0.0673
71066560|NCT01019694|141641702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.0245||95.0|0.04|0.54|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.54|0.04|0.0245
71066561|NCT01019694|141641704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.5695||95.0|-0.24|0.13|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.13|-0.24|0.5695
71066562|NCT01019694|141641704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3093||95.0|-0.28|0.09|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.09|-0.28|0.3093
71066563|NCT01019694|141641705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3578||95.0|-0.31|0.11|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.11|-0.31|0.3578
71066564|NCT01019694|141641705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.7433||95.0|-0.18|0.25|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.25|-0.18|0.7433
71066565|NCT01019694|141641706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.524||95.0|-0.29|0.15|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.15|-0.29|0.524
71066566|NCT01019694|141641706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3171||95.0|-0.34|0.11|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.11|-0.34|0.3171
70852716|NCT01578850|141194336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.049|TWO_SIDED|95.0|-4.19|-0.01|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Week 28||-0.01|-4.19|0.049
70852717|NCT01578850|141194336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.38||||0.005|TWO_SIDED|95.0|-5.72|-1.05|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Week 36||-1.05|-5.72|0.005
70938458|NCT01020487|141377219|SUPERIORITY_OR_OTHER||Difference|27.8||||0.045|TWO_SIDED|95.0|7.5|52.8|||Fisher Exact|||Treatment effects were evaluated based on a two-sided significance level of 0.050. The primary efficacy analysis was a comparison between the paricalcitol capsules and placebo groups in the percentage of participants achieving 2 consecutive ≥ 30% reductions in iPTH from baseline regardless of CKD stage conducted using Fisher's exact test.||52.8|7.5|0.045
71066567|NCT01019694|141641707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.2499||95.0|-0.38|0.1|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.10|-0.38|0.2499
71066568|NCT01019694|141641707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.6144||95.0|-0.31|0.18|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.18|-0.31|0.6144
71066569|NCT01019694|141641708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.5142||95.0|-0.16|0.33|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.33|-0.16|0.5142
71066570|NCT01019694|141641708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.2691||95.0|-0.39|0.11|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.11|-0.39|0.2691
71066571|NCT01019694|141641710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.6236||95.0|-0.23|0.14|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.14|-0.23|0.6236
71066572|NCT01019694|141641710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3342||95.0|-0.28|0.09|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.09|-0.28|0.3342
71066573|NCT01019694|141641711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.1884||95.0|-0.36|0.07|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.07|-0.36|0.1884
71066574|NCT01019694|141641711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.6978||95.0|-0.17|0.26|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.26|-0.17|0.6978
71066575|NCT01019694|141641712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.4197||95.0|-0.32|0.13|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.13|-0.32|0.4197
71066576|NCT01019694|141641712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3949||95.0|-0.33|0.13|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.13|-0.33|0.3949
71066577|NCT01019694|141641713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.299||95.0|-0.38|0.12|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.12|-0.38|0.299
71066578|NCT01019694|141641713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.1404||95.0|-0.44|0.06|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.06|-0.44|0.1404
71066579|NCT01019694|141641714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.463||95.0|-0.36|0.16|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.16|-0.36|0.463
71111960|NCT00910910|141730643|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.826|TWO_SIDED|90.0|0.58|1.52|||Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups|||1.52|0.58|0.826
71066580|NCT01019694|141641714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.3824||95.0|-0.15|0.38|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.38|-0.15|0.3824
71066581|NCT01019694|141641715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.8282||95.0|-0.036|0.045|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.045|-0.036|0.8282
71066582|NCT01019694|141641715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.6587||95.0|-0.032|0.05|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.050|-0.032|0.6587
71066583|NCT01019694|141641716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.1185||95.0|-0.009|0.081|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.081|-0.009|0.1185
71066584|NCT01019694|141641716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.2651||95.0|-0.02|0.072|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.072|-0.020|0.2651
71066585|NCT01019694|141641717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.5852||95.0|-0.058|0.033|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.033|-0.058|0.5852
71066586|NCT01019694|141641717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.7242||95.0|-0.054|0.038|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.038|-0.054|0.7242
71066587|NCT01019694|141641718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.0328||95.0|0.005|0.11|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||||0.110|0.005|0.0328
71066588|NCT01019694|141641718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.8896||95.0|-0.058|0.05|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.050|-0.058|0.8896
71111961|NCT00910910|141730644|SUPERIORITY||Cox Proportional Hazard|0.71||||0.149|TWO_SIDED|90.0|0.48|1.05|||Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|||1.05|0.48|0.149
71111962|NCT00910910|141730647|SUPERIORITY||Cox Proportional Hazard|1.03||||0.883|TWO_SIDED|90.0|0.73|1.46|||Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|||1.46|0.73|0.883
71066589|NCT01019694|141641719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.402||95.0|-0.042|0.105|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.105|-0.042|0.402
71066590|NCT01019694|141641719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.659||95.0|-0.057|0.09|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.090|-0.057|0.659
71066591|NCT01019694|141641720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.0893||95.0|-0.01|0.139|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.139|-0.010|0.0893
71066592|NCT01019694|141641720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.5424||95.0|-0.052|0.099|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.099|-0.052|0.5424
71066593|NCT01019694|141641721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.6396||95.0|-0.104|0.064|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.064|-0.104|0.6396
71066594|NCT01019694|141641721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.6455||95.0|-0.106|0.066|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.066|-0.106|0.6455
71066595|NCT01019694|141641722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.2596||95.0|-0.038|0.141|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.141|-0.038|0.2596
71066596|NCT01019694|141641722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.6659||95.0|-0.112|0.071|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.071|-0.112|0.6659
71066597|NCT01019694|141641724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.476||95.0|-0.4|0.19|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.19|-0.40|0.476
71066598|NCT01019694|141641724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.6976||95.0|-0.35|0.23|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.23|-0.35|0.6976
71066599|NCT01019694|141641725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9506||95.0|-0.4|0.37|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.37|-0.40|0.9506
71066600|NCT01019694|141641725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.2362||95.0|-0.15|0.62|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.62|-0.15|0.2362
71066601|NCT01019694|141641726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.5645||95.0|-0.3|0.54|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.54|-0.30|0.5645
71066602|NCT01019694|141641726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.0163||95.0|0.1|0.95|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.95|0.10|0.0163
71066603|NCT01019694|141641727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.4339||95.0|-0.6|0.26|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.26|-0.60|0.4339
71066604|NCT01019694|141641727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.4886||95.0|-0.28|0.59|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.59|-0.28|0.4886
71066605|NCT01019694|141641728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.7637||95.0|-0.5|0.37|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.37|-0.50|0.7637
71066606|NCT01019694|141641728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.3755||95.0|-0.24|0.65|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.65|-0.24|0.3755
71066607|NCT04244084|141641731|SUPERIORITY||Median Difference (Final Values)|-0.89||||0.0155|TWO_SIDED|95.0|-1.61|-0.17|||ANCOVA|Site used as covariate||Mean differences (MMH-407 vs. Placebo) were compared||-0.17|-1.61|0.0155
71111963|NCT00910910|141730648|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.06||||0.709|TWO_SIDED|90.0|0.83|1.34|||stratified log rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups|||1.34|0.83|0.709
70938459|NCT01020487|141377220|SUPERIORITY_OR_OTHER|||||||0.128|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CHM) test, adjusting for CKD Stage.||||||0.128
71066608|NCT04244084|141641732|SUPERIORITY|||||||0.1839|||||||Wilcoxon (Mann-Whitney)|||||||0.1839
71066609|NCT04244084|141641733|SUPERIORITY|||||||0.064||||||Day used as independent strata.|Cochran-Mantel-Haenszel|||||||0.0640
71066610|NCT04244084|141641734|SUPERIORITY|||||||0.1927|||||||Wilcoxon (Mann-Whitney)|||||||0.1927
71066611|NCT04244084|141641735|SUPERIORITY|||||||0.0014||||||Day used as independent strata.|Cochran-Mantel-Haenszel|||||||0.0014
71066612|NCT04244084|141641736|SUPERIORITY|||||||0.2009|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to Day 1 row."||||0.2009
71066613|NCT04244084|141641736|SUPERIORITY|||||||0.4717|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to Day 2 row."||||0.4717
71111964|NCT01434654|141730725|SUPERIORITY_OR_OTHER|||||||0.99||||||P-value for arm\*time interaction fixed effect.|Mixed Models Analysis|49 datapoints included from baseline, 6 months, and 12 months visits (low CNS penetrance n=14; high CNS penetrance n=35)||The primary outcome was analysed using a mixed-effect regression model with arm and time as fixed linear effects, arm\*time interaction as a non-linear fixed effect and participant as a random effect to account for participant attrition.||||0.99
71111965|NCT01434654|141730726|SUPERIORITY_OR_OTHER|||||||0.58|||||||ANOVA|||Change in NAA/H20 levels was analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.58
71111966|NCT01434654|141730726|SUPERIORITY_OR_OTHER|||||||0.44|||||||ANOVA|||Change in Cr/H20 levels was analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.44
71111967|NCT01434654|141730726|SUPERIORITY_OR_OTHER|||||||0.86|||||||ANOVA|||Change in Cho/H20 levels was analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.86
71111968|NCT01434654|141730726|SUPERIORITY_OR_OTHER|||||||0.98|||||||ANOVA|||Change in mIo/H20 levels was analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.98
71111969|NCT01434654|141730727|SUPERIORITY_OR_OTHER|||||||0.16|||||||ANOVA|||Change in NAA/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.16
71111970|NCT01434654|141730727|SUPERIORITY_OR_OTHER|||||||0.09|||||||ANOVA|||Change in Cr/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.09
71111971|NCT01434654|141730727|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANOVA|||Change in Cho/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.06
71111972|NCT01434654|141730727|SUPERIORITY_OR_OTHER|||||||0.68|||||||ANOVA|||Change in mIo/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.68
71111973|NCT01434654|141730727|SUPERIORITY_OR_OTHER|||||||0.58|||||||ANOVA|||Change in Glx/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.58
71111974|NCT00703963|141730731|SUPERIORITY_OR_OTHER|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Statistical significance was defined as p \< 0.05.||||0.20
71111975|NCT00703963|141730732|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Statistical significance was defined as p \< 0.05.||||0.05
71111976|NCT00703963|141730733|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Statistical significance was defined as p \< 0.05.||||<0.001
71111977|NCT00402324|141730736|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||All tests of treatment effects will be conducted at a two-sided alpha level of 0.05 unless otherwise stated.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) Change = Therapy PooledINV Visit Baseline Baseline\*Visit Therapy\*Visit. P-value from therapy term in model.||The overall power of the two co-primary analyses-the probability of simultaneously rejecting both co-primary null hypotheses-for this sample size under assumed effect sizes of 0.5 and 0.45 is estimated as approximately 85-87% and 77-80%, respectively.||||<0.001
71111978|NCT00402324|141730737|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||All tests of treatment effects will be conducted at a two-sided alpha level of 0.05 unless otherwise stated.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) Change = Therapy PooledINV Visit Baseline Baseline\*Visit Therapy\*Visit. P-value from therapy term in model.||The overall power of the two co-primary analyses-the probability of simultaneously rejecting both co-primary null hypotheses-for this sample size under assumed effect sizes of 0.5 and 0.45 is estimated as approximately 85-87% and 77-80%, respectively.||||0.022
71111979|NCT00402324|141730738|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Fisher Exact|||||||0.100
71111980|NCT00402324|141730739|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||Fisher Exact|||||||0.048
71111981|NCT00402324|141730740|SUPERIORITY_OR_OTHER|||||||0.056||95.0|||||ANCOVA|Type III sums of squares of ANCOVA model: Change= TRT + Pooled Investigator + Baseline.||||||0.056
71111982|NCT00402324|141730742|SUPERIORITY_OR_OTHER|||||||0.657||95.0||||P-value for Total Cholesterol Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator||||||0.657
71111983|NCT00402324|141730742|SUPERIORITY_OR_OTHER|||||||0.924||95.0||||P-value for Low Density Lipoprotein Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator||||||0.924
71111984|NCT00402324|141730742|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||P-value for High Density Lipoprotein Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator||||||0.122
71111985|NCT00402324|141730743|SUPERIORITY_OR_OTHER|||||||0.293||95.0||||P-value for Fasting Triglycerides Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator||||||0.293
71111986|NCT00402324|141730744|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value for Fasting Blood Glucose Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator||||||0.007
71111987|NCT00402324|141730745|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||P-value for Bilirubin Total Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator||||||0.046
71111988|NCT00402324|141730746|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Type III sums of squares of ANCOVA model: Change= Treatment + Pooled Investigator + Baseline||||||<0.001
71111989|NCT00402324|141730747|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Type III sums of squares of ANCOVA model: Change= Treatment + Pooled Investigator + Baseline||||||<0.001
71111990|NCT00402324|141730748|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71111991|NCT01277822|141730749|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin was 3 mmHg as Korean Food and Drug Administration (KFDA) guidance.|Mean Difference (Final Values)|-1.3|STANDARD_DEVIATION|7.7||0.1339|TWO_SIDED|95.0|-3.0|0.4|||t-test, 2 sided|Last observed non-missing, post-baseline value was imputed for missing value. If no such value existed, the value was treated as missing in analysis||||0.4|-3.0|0.1339
71111992|NCT01277822|141730750|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4478||||||No imputation for missing data was performed|t-test, 2 sided|||||||0.4478
71111993|NCT01277822|141730751|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0717|||||||t-test, 2 sided|Last observed non-missing, post-baseline value was imputed for missing value. If no such value existed, the value was treated as missing in analysis||||||0.0717
71111994|NCT01277822|141730752|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8736|||||||t-test, 2 sided|No imputation for missing data was performed||||||0.8736
71111995|NCT01277822|141730753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2508||||||No imputation for missing data was performed|Chi-squared|||||||0.2508
71066614|NCT04244084|141641736|SUPERIORITY|||||||0.5144|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to Day 3 row."||||0.5144
71066615|NCT04244084|141641737|SUPERIORITY|||||||0.62|||||||Fisher Exact|||||||0.62
71066616|NCT04244084|141641739|SUPERIORITY|||||||0.5981|||||||Kruskal-Wallis|||"This analysis applies to Systolic blood pressure/Visit 1 row."||||0.5981
71066617|NCT04244084|141641739|SUPERIORITY|||||||0.4913|||||||Kruskal-Wallis|||"This analysis applies to Systolic blood pressure/Visit 2 row."||||0.4913
71066618|NCT04244084|141641739|SUPERIORITY|||||||0.6441|||||||Kruskal-Wallis|||"This analysis applies to Systolic blood pressure/Visit 3 row."||||0.6441
71066619|NCT04244084|141641739|SUPERIORITY|||||||0.8186|||||||Kruskal-Wallis|||"This analysis applies to Diastolic blood pressure/Visit 1 row."||||0.8186
71066620|NCT04244084|141641739|SUPERIORITY|||||||0.8931|||||||Kruskal-Wallis|||"This analysis applies to Diastolic blood pressure/Visit 2 row."||||0.8931
71066621|NCT04244084|141641739|SUPERIORITY|||||||0.5887|||||||Kruskal-Wallis|||"This analysis applies to Diastolic blood pressure/Visit 3 row."||||0.5887
71066622|NCT04244084|141641740|SUPERIORITY|||||||0.4426|||||||Kruskal-Wallis|||"This analysis applies to Heart rate/Visit 1 row."||||0.4426
71066623|NCT04244084|141641740|SUPERIORITY|||||||0.5998|||||||Kruskal-Wallis|||"This analysis applies to Heart rate/Visit 2 row."||||0.5998
71066624|NCT04244084|141641740|SUPERIORITY|||||||0.971|||||||Kruskal-Wallis|||"This analysis applies to Heart rate/Visit 3 row."||||0.9710
71066625|NCT04244084|141641741|SUPERIORITY|||||||0.6197|||||||Kruskal-Wallis|||"This analysis applies to Breathing rate/Visit 1 row."||||0.6197
71066626|NCT04244084|141641741|SUPERIORITY|||||||0.7042|||||||Kruskal-Wallis|||"This analysis applies to Breathing rate/Visit 2 row."||||0.7042
71066627|NCT04244084|141641741|SUPERIORITY|||||||0.7693|||||||Kruskal-Wallis|||"This analysis applies to Breathing rate/Visit 3 row."||||0.7693
71066628|NCT04244084|141641742|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71066629|NCT04632069|141641761|SUPERIORITY||Mean Difference (Final Values)|2.1|STANDARD_DEVIATION|0.4||0.009|TWO_SIDED||||||Regression, Linear|repeated measures linear regression: time periods: -14 to Day 0, Day 1-18(independent variable); daily po volumes (Dependent Variable)||Daily change in po feeding volumes expressed as po ml/kg/d \[reported as the mean daily change from Day 1 to 18 during NAC/NAC+taVNS minus baseline mean daily change Day -14 to day 0 (before treatment)\] Null hypothesis: there will be no significant difference in daily change in po feeding volume (ml/kg/d) from baseline to during treatment Power analysis: Estimated +0.2 ml/kg/d before taVNS, and +3ml/kg/d during the 18days of NAC+taVNS treatment, requiring 10 infants with power of 80%, a=0.05.||||0.009
71066630|NCT04632069|141641762|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_DEVIATION|0.08||0.01|TWO_SIDED||||||t-test, 2 sided|paired t-test|mean difference between \[GSH\] Day 4 of NAC and \[GSH\] at baseline|\[GSH\] at baseline compared with \[GSH\] at day 4 of NAC- by paired t-test in which each participant's \[GSH\] is compared at 2 time points Null hypothesis: the \[GSH\] in the basal ganglia will be no different after Day 4 of NAC than \[GSH\] at baseline Power calculation:With 80% power, alpha of 0.05, we would need 7 patients to show a significant change in basal ganglia \[GSH\] of 0.14 +/- 0.13mM from baseline to Day 4 of NAC (paired t-test).||||0.01
71066631|NCT03412734|141641776|OTHER||Odds Ratio (OR)|10.6|||<|0.001|TWO_SIDED|95.0|3.02|37.34||p-value is adjusted for baseline BV (Bacterial Vaginosis)|Regression, Logistic|||We hypothesized that chlorhexidine would have a lower bacterial count compared to iodine. Our sample size was calculated to be 71 patients per arm to detect a 22% difference in cultures defined as contaminated at 90 minutes from surgical preparation.||37.34|3.02|<0.001
71066632|NCT00927862|141641786|NON_INFERIORITY_OR_EQUIVALENCE|Based on power calculations and feasibility, the minimum recruitment target for the randomized, PG-guided comparison was set at 500 patients. All qualifying parallel control patients were included, anticipated to number ≥1000. For hypothesis 1, the power to exclude inferiority of the modified PG arm vs standard PG arm at a margin (delta) of 5% with 250 patients per group at a 2-sided alpha \<0.05 is 87%, assuming a common standard deviation of 0.20.|Mean Difference (Final Values)|0.34|STANDARD_DEVIATION|0.2|<|0.05|TWO_SIDED|95.0||||Comparisons between groups for primary endpoints were made using the unpaired T-test.|t-test, 2 sided|||Comparisons between groups for primary endpoints were made using the unpaired T-test. All consented, randomized patients who were successfully genotyped and received at least one dose of warfarin with at least one post-dose INR were included in efficacy analyses (modified intention to treat \[mITT\]).||||<0.05
71066633|NCT00820248|141641795|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.83|TWO_SIDED|95.0|0.6|1.5|||Regression, Cox||Hazard ratio of panitumumab vs cisplatin|The log rank test stratified by the stratification factors at randomization was used to compare the difference in PFS between two treatment arms.||1.50|0.60|0.83
71066634|NCT00820248|141641796|SUPERIORITY||Cox Proportional Hazard|0.89||||0.66|TWO_SIDED|95.0|0.54|1.48|||Log Rank||hazard ratio for panitumumab vs cisplatin|||1.48|0.54|0.66
71066635|NCT00862823|141641863|NON_INFERIORITY_OR_EQUIVALENCE|The sample size was determined so there was an 80% chance that a 90% pairwise interval for 2 equivalent formulations would satifsy the FDA criteria for AUC and Cmax of log (0.8), log (1.2).|Geometric Mean Ratio|0.97|||<|0.05||90.0||||Bioequivalent measurew were log-transformed|log transformation|||||||<0.05
71066636|NCT02049814|141641865|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of 95% CI of Least Square Mean (LS mean) of HbA1C Changes was less than 0.4%, it was considered that the non-inferiority was established.||||||0.0001|||||||Paired t-test|||||||0.0001
71066637|NCT02307279|141641940|SUPERIORITY||Mean Difference (Net)|-2.07|STANDARD_ERROR_OF_MEAN|0.59||0.0007|TWO_SIDED|95.0|-3.24|-0.9|||ANCOVA|Adjusted for stratification factors, and baseline weight|Difference in adjusted mean taken for comparability between the two groups (treatment - placebo)|Simple Superiority, H0: μ (Placebo) -μ (Gelesis100) = 0||-0.90|-3.24|0.0007
71066638|NCT02307279|141641940|SUPERIORITY|||||||0.1193|||||||ANCOVA|Adjusted for stratification factors, and baseline weight||Super-Superiority (\>3% difference), H0: μ(Placebo)-μ(Gelesis100) \< 3%||||0.1193
71066639|NCT02307279|141641941|SUPERIORITY|The performance goal for body weight responders was set at 35%.|||||<|0.0001|||||||Binomial Proportion Test|||H0: π (Gelesis100)\< 0.35||||<0.0001
71066640|NCT02307279|141641941|SUPERIORITY||Odds Ratio (OR)|2.01||||0.0008|TWO_SIDED|95.0|1.34|3.01|||Regression, Logistic|Adjusted for stratification factors and baseline weight||"OR-trt refers to the odds ratio of being a body weight responder for Gelesis100 vs. Placebo.~H0: OR-trt= 1."||3.01|1.34|0.0008
71066641|NCT02484456|141641948|SUPERIORITY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.79||0.68|TWO_SIDED||||||Mixed Models Analysis|||||||0.68
71066642|NCT02484456|141641949|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.72||0.83|TWO_SIDED||||||Mixed Models Analysis|||||||0.83
71066643|NCT02484456|141641950|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.89||0.71|TWO_SIDED||||||Mixed Models Analysis|||||||0.71
71066644|NCT02484456|141641951|SUPERIORITY||Mean Difference (Final Values)|1.23|STANDARD_ERROR_OF_MEAN|1.06||0.25|TWO_SIDED||||||Mixed Models Analysis|||||||0.25
71066645|NCT02484456|141641952|SUPERIORITY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|1.27||0.51|TWO_SIDED||||||Mixed Models Analysis|||||||0.51
71066646|NCT02484456|141641953|SUPERIORITY||Mean Difference (Final Values)|-1.83|STANDARD_ERROR_OF_MEAN|1.58||0.26|TWO_SIDED||||||Mixed Models Analysis|||||||0.26
71066647|NCT02484456|141641954|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|1.02||0.67|TWO_SIDED||||||Mixed Models Analysis|||||||0.67
71066648|NCT02484456|141641955|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|1.34||0.99|TWO_SIDED||||||Mixed Models Analysis|||||||0.99
71066649|NCT02484456|141641956|SUPERIORITY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|1.2||0.83|TWO_SIDED||||||Mixed Models Analysis|||||||0.83
71066650|NCT02484456|141641957|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|1.51||0.51|TWO_SIDED||||||Mixed Models Analysis|||||||0.51
71066651|NCT02484456|141641958|SUPERIORITY||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|1.76||0.37|TWO_SIDED||||||Mixed Models Analysis|||||||0.37
71066652|NCT02484456|141641959|SUPERIORITY||Mean Difference (Final Values)|-2.02|STANDARD_ERROR_OF_MEAN|1.89||0.29|TWO_SIDED||||||Mixed Models Analysis|||||||0.29
71066653|NCT02484456|141641960|SUPERIORITY||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.92||0.6|TWO_SIDED||||||Mixed Models Analysis|||||||0.60
71066654|NCT02484456|141641961|SUPERIORITY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.98||0.53|TWO_SIDED||||||Mixed Models Analysis|||||||0.53
71066655|NCT02484456|141641962|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|1.1||0.88|TWO_SIDED||||||Mixed Models Analysis|||||||0.88
71066656|NCT02484456|141641963|SUPERIORITY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|0.91||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.13
71066657|NCT02484456|141641964|SUPERIORITY||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|1.3||0.38|TWO_SIDED||||||Mixed Models Analysis|||||||0.38
71066658|NCT02484456|141641965|SUPERIORITY||Mean Difference (Final Values)|-2.05|STANDARD_ERROR_OF_MEAN|1.26||0.12|TWO_SIDED||||||Mixed Models Analysis|||||||0.12
71066659|NCT02484456|141641966|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.98||0.84|TWO_SIDED||||||Mixed Models Analysis|||||||0.84
71066660|NCT02484456|141641967|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|1.23||0.97|TWO_SIDED||||||Mixed Models Analysis|||||||0.97
71066661|NCT02484456|141641968|SUPERIORITY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|1.39||0.81|TWO_SIDED||||||Mixed Models Analysis|||||||0.81
71066662|NCT02484456|141641969|SUPERIORITY||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|1.31||0.47|TWO_SIDED||||||Mixed Models Analysis|||||||0.47
71066663|NCT02484456|141641970|SUPERIORITY||Mean Difference (Final Values)|-1.82|STANDARD_ERROR_OF_MEAN|1.89||0.35|TWO_SIDED||||||Mixed Models Analysis|||||||0.35
71066664|NCT02484456|141641971|SUPERIORITY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|1.63||0.12|TWO_SIDED||||||Mixed Models Analysis|||||||0.12
71066665|NCT02411396|141642022|OTHER|In order to eliminate bias from the naïve estimation on the treatment effects due to the confounders, time varying propensity score model was developed. This balanced the covariates between the two arms at each single acute visit of each patient. A sub classification on the propensity scores was used to estimate the potential outcome for each arm and the average treatment effects (ATE). Bootstrapping was employed to estimate the standard error of ATE.|Mean Difference (Final Values)|124.6|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|118.3|130.9||||||This analysis is to compare outcome measure between ED or IC visits by using time varying propensity score method developed by our group to adjust imbalance of covariates between the two arms. Each patient can have multiple visits to the facility of choice.||130.9|118.3|
71066666|NCT02411396|141642023|OTHER|In order to eliminate bias from the naïve estimation on the treatment effects due to the confounders, time varying propensity score model was developed. This balanced the covariates between the two arms at each single acute visit of each patient. A sub classification on the propensity scores was used to estimate the potential outcome for each arm and the average treatment effects (ATE). Bootstrapping was employed to estimate the standard error of ATE.|Odds Ratio (OR)|5.14|||||TWO_SIDED|95.0|4.13|6.41|||||VOC in patients with SCD whom went to EDs represents the numerator, VOC in patients with SCD whom went to ICs represents the denominator for Odds Ratio.|||6.41|4.13|
71066667|NCT02411396|141642024|OTHER|In order to eliminate bias from the naïve estimation on the treatment effects due to the confounders, time varying propensity score model was developed. This balanced the covariates between the two arms at each single acute visit of each patient. A sub classification on the propensity scores was used to estimate the potential outcome for each arm and the average treatment effects (ATE). Bootstrapping was employed to estimate the standard error of ATE.|Odds Ratio (OR)|2.24|||||TWO_SIDED|95.0|1.84|2.72|||||VOC in patients with SCD whom went to ICs represents the numerator, VOC in patients with SCD whom went to EDs represents the denominator for Odds Ratio.|||2.72|1.84|
70852718|NCT01578850|141194336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.02|||<|0.001|TWO_SIDED|95.0|-6.37|-1.67|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Week 44||-1.67|-6.37|<0.001
70852719|NCT01578850|141194336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.02|||<|0.001|TWO_SIDED|95.0|-6.36|-1.68|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Week 52||-1.68|-6.36|<0.001
71066668|NCT02064816|141642040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_DEVIATION|3.5||0.277763|TWO_SIDED|95.0|-0.46|1.56|||Mann-Whitney Non Parametric test|||||1.56|-0.46|0.277763
71066669|NCT02064816|141642041|SUPERIORITY_OR_OTHER||Least Square (LS) Mean difference|1.3492||||0.0083|TWO_SIDED|95.0|0.3495|2.3489|||linear mixed model for repeated measures|||Week 4||2.3489|0.3495|0.0083
71066670|NCT02064816|141642041|SUPERIORITY_OR_OTHER||LS Mean difference|1.3367||||0.0079|TWO_SIDED|95.0|0.3534|2.32|||linear mixed model for repeated measures|||Week 8||2.3200|0.3534|0.0079
71066671|NCT02064816|141642042|SUPERIORITY_OR_OTHER||LS Mean difference|0.4003||||0.4311|TWO_SIDED|95.0|-0.5992|1.3998|||linear mixed model for repeated measures|||ISRs subscale Week 4||1.3998|-0.5992|0.4311
71066672|NCT02064816|141642042|SUPERIORITY_OR_OTHER||LS Mean difference|0.08479||||0.8635|TWO_SIDED|95.0|-0.885|1.0546|||linear mixed model for repeated measures|||ISRs subscale Week 8||1.0546|-0.8850|0.8635
71066673|NCT02064816|141642042|SUPERIORITY_OR_OTHER||LS Mean difference|-0.3245||||0.5099|TWO_SIDED|95.0|-1.2927|0.6437|||linear mixed model for repeated measures|||ISRs subscale Week 12||0.6437|-1.2927|0.5099
71066674|NCT02064816|141642042|SUPERIORITY_OR_OTHER||LS Mean difference|-0.07079||||0.8574|TWO_SIDED|95.0|-0.8452|0.7036|||linear mixed model for repeated measures|||Global side-effect subscale: Week 4||0.7036|-0.8452|0.8574
71066675|NCT02064816|141642042|SUPERIORITY_OR_OTHER||LS Mean difference|0.1897||||0.6338|TWO_SIDED|95.0|-0.5926|0.972|||linear mixed model for repeated measures|||Global side-effect subscale: Week 8||0.9720|-0.5926|0.6338
71066676|NCT02064816|141642042|SUPERIORITY_OR_OTHER||LS Mean difference|0.4097||||0.3042|TWO_SIDED|95.0|-0.3734|1.1929|||linear mixed model for repeated measures|||Global side-effect subscale: Week 12||1.1929|-0.3734|0.3042
71066677|NCT02064816|141642042|SUPERIORITY_OR_OTHER||LS Mean difference|-0.4083||||0.1038|TWO_SIDED|95.0|-0.9008|0.08419|||linear mixed model for repeated measures|||Benefits: Week 4||0.08419|-0.9008|0.1038
71066678|NCT02064816|141642042|SUPERIORITY_OR_OTHER||LS Mean difference|-0.1358||||0.594|TWO_SIDED|95.0|-0.637|0.3653|||linear mixed model for repeated measures|||Benefits: Week 8||0.3653|-0.6370|0.5940
71066679|NCT02064816|141642042|SUPERIORITY_OR_OTHER||LS Mean difference|-0.05809||||0.8217|TWO_SIDED|95.0|-0.5651|0.4489|||linear mixed model for repeated measures|||Benefits: Week 12||0.4489|-0.5651|0.8217
71066680|NCT02064816|141642042|SUPERIORITY_OR_OTHER||LS Mean difference|0.5909||||0.489|TWO_SIDED|95.0|-1.0873|2.269|||linear mixed model for repeated measures|||Description of pain: Week 4||2.2690|-1.0873|0.4890
71066681|NCT02064816|141642042|SUPERIORITY_OR_OTHER||LS Mean difference|-0.7689||||0.3719|TWO_SIDED|95.0|-2.4607|0.9229|||linear mixed model for repeated measures|||Description of pain: Week 8||0.9229|-2.4607|0.3719
71066682|NCT02064816|141642042|SUPERIORITY_OR_OTHER||LS Mean difference|0.1422||||0.869|TWO_SIDED|95.0|-1.5521|1.8364|||linear mixed model for repeated measures|||Description of pain: Week 12||1.8364|-1.5521|0.8690
71066683|NCT02064816|141642042|SUPERIORITY_OR_OTHER||LS Mean difference|0.6544||||0.8328|TWO_SIDED|95.0|-5.4393|6.7482|||linear mixed model for repeated measures|||VAS: Week 4||6.7482|-5.4393|0.8328
71066684|NCT02064816|141642042|SUPERIORITY_OR_OTHER||LS Mean difference|-2.2294||||0.4764|TWO_SIDED|95.0|-8.38|3.9212|||linear mixed model for repeated measures|||VAS: Week 8||3.9212|-8.3800|0.4764
71066685|NCT02064816|141642042|SUPERIORITY_OR_OTHER||LS Mean difference|-5.4196||||0.0852|TWO_SIDED|95.0|-11.5939|0.7547|||linear mixed model for repeated measures|||VAS: Week 12||0.7547|-11.5939|0.0852
71066686|NCT02064816|141642042|SUPERIORITY_OR_OTHER||LS Mean difference|0.006873||||0.9639|TWO_SIDED|95.0|-0.2918|0.3055|||linear mixed model for repeated measures|||Rating of pain: Week 4||0.3055|-0.2918|0.9639
71066687|NCT02064816|141642042|SUPERIORITY_OR_OTHER||LS Mean difference|-0.08689||||0.5715|TWO_SIDED|95.0|-0.3886|0.2148|||linear mixed model for repeated measures|||Rating of pain: Week 8||0.2148|-0.3886|0.5715
71066688|NCT02064816|141642042|SUPERIORITY_OR_OTHER||LS Mean difference|-0.2224||||0.1502|TWO_SIDED|95.0|-0.5256|0.0809|||linear mixed model for repeated measures|||Rating of pain: Week 12||0.08090|-0.5256|0.1502
71066689|NCT01732458|141642096|SUPERIORITY_OR_OTHER||Difference in Percentage vs. Ondansetron|-16.5|||||TWO_SIDED|95.0|-34.0|2.0||||||The Miettinen and Nurminen method was used to provide 95% confidence intervals (CIs) for between-treatment differences in the percentage of participants with events.||2.0|-34.0|
71066690|NCT01732458|141642096|SUPERIORITY_OR_OTHER||Difference in Percentage vs. Ondansetron|-4.4|||||TWO_SIDED|95.0|-22.9|14.3||||||The Miettinen and Nurminen method was used to provide 95% confidence intervals (CIs) for between-treatment differences in the percentage of participants with events.||14.3|-22.9|
71066691|NCT01732458|141642096|SUPERIORITY_OR_OTHER||Difference in Percentage vs. Ondansetron|-12.4|||||TWO_SIDED|95.0|-30.3|6.3||||||The Miettinen and Nurminen method was used to provide 95% confidence intervals (CIs) for between-treatment differences in the percentage of participants with events.||6.3|-30.3|
71066692|NCT00570063|141642121|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-1.61|STANDARD_ERROR_OF_MEAN|8.94||0.86|TWO_SIDED|90.0|-16.49|13.27|||Mixed Models Analysis|||P-value and 90 percent confidence interval (CI) were obtained from mixed effects repeated measures analysis using covariance structures spatial power covariance structure (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||13.27|-16.49|0.86
71066693|NCT00570063|141642122|SUPERIORITY_OR_OTHER||LS mean difference|-1.23|STANDARD_ERROR_OF_MEAN|2.69||0.65|TWO_SIDED|90.0|-5.71|3.24|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||3.24|-5.71|0.65
71111996|NCT01277822|141730754|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2508||||||No imputation for missing data was performed|Chi-squared|||||||0.2508
71111997|NCT01277822|141730755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6646|||||||Chi-squared|||||||0.6646
71066694|NCT00570063|141642123|SUPERIORITY_OR_OTHER||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|2.61||0.93|TWO_SIDED|90.0|-4.59|4.1|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||4.10|-4.59|0.93
71066695|NCT00570063|141642124|SUPERIORITY_OR_OTHER||LS mean difference|0.74|STANDARD_ERROR_OF_MEAN|4.18||0.86|TWO_SIDED|90.0|-6.21|7.69|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||7.69|-6.21|0.86
71066696|NCT00570063|141642125|SUPERIORITY_OR_OTHER||LS mean difference|-2.57|STANDARD_ERROR_OF_MEAN|3.22||0.43|TWO_SIDED|90.0|-7.92|2.79|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||2.79|-7.92|0.43
71066697|NCT00570063|141642126|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|2.68||0.91|TWO_SIDED|90.0|-4.76|4.16|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||4.16|-4.76|0.91
71066698|NCT00570063|141642127|SUPERIORITY_OR_OTHER||LS mean difference|0.63|STANDARD_ERROR_OF_MEAN|2.29||0.78|TWO_SIDED|90.0|-3.17|4.43|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||4.43|-3.17|0.78
71066699|NCT00570063|141642128|SUPERIORITY_OR_OTHER||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|1.35||0.92|TWO_SIDED|90.0|-2.11|2.39|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||2.39|-2.11|0.92
71066700|NCT00570063|141642129|SUPERIORITY_OR_OTHER||LS mean difference|0.84|STANDARD_ERROR_OF_MEAN|1.62||0.6|TWO_SIDED|90.0|-1.85|3.54|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||3.54|-1.85|0.60
71066701|NCT00570063|141642130|SUPERIORITY_OR_OTHER||LS mean difference|0.44|STANDARD_ERROR_OF_MEAN|1.86||0.81|TWO_SIDED|90.0|-2.65|3.53|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||3.53|-2.65|0.81
71111998|NCT01277822|141730756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7911||||||Left ankle: Last observed non-missing, post-baseline value was imputed for missing value. If no such value existed, the value was treated as missing in analysis|t-test, 2 sided|||||||0.7911
71066702|NCT00570063|141642131|SUPERIORITY_OR_OTHER||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.48||0.93|TWO_SIDED|90.0|-0.84|0.76|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||0.76|-0.84|0.93
71066703|NCT00570063|141642132|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.68||0.99|TWO_SIDED|90.0|-1.13|1.14|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects.||1.14|-1.13|0.99
71111999|NCT01277822|141730756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5933||||||Right ankle: Last observed non-missing, post-baseline value was imputed for missing value. If no such value existed, the value was treated as missing in analysis|t-test, 2 sided|||||||0.5933
71112000|NCT00997984|141730772|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||A hierarchical testing structure was employed. First placebo vs all-active, then placebo vs am and lastly placebo vs pm. Testing was stopped when one comparison was not significant (p\<0.05).|ANCOVA|||Study designed to detect an effect size of 0.4 with 90% at the 0.05 significance level.||||<0.001
71112001|NCT00997984|141730772|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||A hierarchical testing structure was employed. First placebo vs all-active, then placebo vs am and lastly placebo vs pm. Testing was stopped when one comparison was not significant (p\<0.05).|ANCOVA|||Study designed to detect an effect size of 0.4 with 90% at the 0.05 significance level.||||<0.001
71112002|NCT00997984|141730772|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||A hierarchical testing structure was employed. First placebo vs all-active, then placebo vs am and lastly placebo vs pm. Testing was stopped when one comparison was not significant (p\<0.05).|ANCOVA|||Study designed to detect an effect size of 0.4 with 90% at the 0.05 significance level.||||<0.001
71112003|NCT00997984|141730773|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||<0.001
71112004|NCT00997984|141730773|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||<0.001
71112005|NCT00997984|141730773|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||<0.001
71112006|NCT00997984|141730774|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||<0.001
70852720|NCT01578850|141194336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.22||||0.047|TWO_SIDED|95.0|-4.4|-0.03|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Week 28||-0.03|-4.40|0.047
71066704|NCT00570063|141642133|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.158|STANDARD_DEVIATION|0.844|||TWO_SIDED|90.0|-1.546|1.231||||||Change at Day 21: Cried||1.231|-1.546|
71066705|NCT00570063|141642133|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.444|STANDARD_DEVIATION|1.078|||TWO_SIDED|90.0|-1.329|2.218||||||Change at Day 21: Felt blue or depressed||2.218|-1.329|
71066706|NCT00570063|141642133|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.544|STANDARD_DEVIATION|4.32|||TWO_SIDED|90.0|-5.561|8.649||||||Change at Day 21: Irritability||8.649|-5.561|
71066707|NCT00570063|141642133|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.573|STANDARD_DEVIATION|2.955|||TWO_SIDED|90.0|-4.287|5.433||||||Change at Day 21: Manifest psychosis||5.433|-4.287|
71066708|NCT00570063|141642133|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.556|STANDARD_DEVIATION|2.096|||TWO_SIDED|90.0|-2.892|4.003||||||Change at Day 21: Personal neatness||4.003|-2.892|
71066709|NCT00570063|141642133|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.327|STANDARD_DEVIATION|0.532|||TWO_SIDED|90.0|-1.202|0.547||||||Change at Day 21: Refused to speak||0.547|-1.202|
71066710|NCT00570063|141642133|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.632|STANDARD_DEVIATION|2.749|||TWO_SIDED|90.0|-5.152|3.889||||||Change at Day 21: Retardation||3.889|-5.152|
71066711|NCT00570063|141642133|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17|STANDARD_DEVIATION|0.572|||TWO_SIDED|90.0|-1.11|0.771||||||Change at Day 21: Said he/she was no good||0.771|-1.110|
71066712|NCT00570063|141642133|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.561|STANDARD_DEVIATION|2.63|||TWO_SIDED|90.0|-4.887|3.764||||||Change at Day 21: Social competence||3.764|-4.887|
71066713|NCT00570063|141642133|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.62|STANDARD_DEVIATION|4.447|||TWO_SIDED|90.0|-7.934|6.694||||||Change at Day 21: Social interest||6.694|-7.934|
71066714|NCT00570063|141642134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.712|STANDARD_DEVIATION|12.24|||TWO_SIDED|90.0|-14.42|25.845||||||||25.845|-14.42|
71066715|NCT00570063|141642144|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.849|STANDARD_DEVIATION|4.23|||TWO_SIDED|90.0|-7.807|6.109||||||||6.109|-7.807|
71066716|NCT00570063|141642145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.195|STANDARD_DEVIATION|9.307|||TWO_SIDED|90.0|-19.5|11.114||||||||11.114|-19.50|
71066717|NCT00570063|141642146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.273|STANDARD_DEVIATION|3.488|||TWO_SIDED|90.0|-6.01|5.465||||||Change at Day 21: Parkinsonism||5.465|-6.010|
71066718|NCT00570063|141642146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.182|STANDARD_DEVIATION|3.008|||TWO_SIDED|90.0|-5.13|4.766||||||Change at Day 21: Dyskinesia||4.766|-5.130|
71066719|NCT00570063|141642146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.932|STANDARD_DEVIATION|1.425|||TWO_SIDED|90.0|-3.275|1.411||||||Change at Day 21: Dystonia||1.411|-3.275|
71112007|NCT00997984|141730774|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||<0.001
71066720|NCT00570063|141642146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.705|STANDARD_DEVIATION|1.652|||TWO_SIDED|90.0|-2.013|3.422||||||Change at Day 21: Akathisia||3.422|-2.013|
71066721|NCT00570063|141642147|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.291|STANDARD_DEVIATION|1.203|||TWO_SIDED|90.0|-2.27|1.688||||||Change at Day 4||1.688|-2.270|
71066722|NCT00570063|141642147|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.327|STANDARD_DEVIATION|1.349|||TWO_SIDED|90.0|-1.892|2.547||||||Change at Day 7||2.547|-1.892|
71066723|NCT00570063|141642147|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.436|STANDARD_DEVIATION|1.448|||TWO_SIDED|90.0|-1.946|2.817||||||Change at Day 14||2.817|-1.946|
71066724|NCT00570063|141642147|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|1.133|||TWO_SIDED|90.0|-1.763|1.963||||||Change at Day 21||1.963|-1.763|
71066725|NCT03307252|141642152|OTHER||Adjusted geometric mean (gMean) ratio|100.7|STANDARD_ERROR_OF_MEAN|17.9|||TWO_SIDED|90.0|88.84|114.15|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|114.15|88.84|
71066726|NCT03307252|141642152|OTHER||Adjusted gMean ratio|93.76|STANDARD_ERROR_OF_MEAN|12.1|||TWO_SIDED|90.0|86.12|102.06|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|102.06|86.12|
71066727|NCT03307252|141642152|OTHER||Adjusted gMean Ratio|82.97|STANDARD_ERROR_OF_MEAN|10.7|||TWO_SIDED|90.0|76.96|89.46|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|89.46|76.96|
71112008|NCT00997984|141730774|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||<0.001
71112009|NCT00997984|141730775|SUPERIORITY_OR_OTHER_LEGACY|||||||0.099||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.099
71112010|NCT00997984|141730775|SUPERIORITY_OR_OTHER_LEGACY|||||||0.596||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.596
71112011|NCT00997984|141730775|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.023
71112012|NCT00997984|141730777|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||<0.001
71112013|NCT00997984|141730777|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||<0.001
71112014|NCT00997984|141730777|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||<0.001
71112015|NCT00997984|141730778|SUPERIORITY_OR_OTHER_LEGACY|||||||0.712||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.712
71066728|NCT03307252|141642152|OTHER||Adjusted gMean Ratio|113.4|STANDARD_ERROR_OF_MEAN|21.5|||TWO_SIDED|90.0|97.62|131.72|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|131.72|97.62|
71066729|NCT03307252|141642153|OTHER||Adjusted geometric mean (gMean) ratio|131.41|STANDARD_ERROR_OF_MEAN|17.9|||TWO_SIDED|90.0|115.93|148.97|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|148.97|115.93|
71066730|NCT03307252|141642153|OTHER||Adjusted gMean ratio|119.78|STANDARD_ERROR_OF_MEAN|12.1|||TWO_SIDED|90.0|110.03|130.39|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|130.39|110.03|
71066731|NCT03307252|141642153|OTHER||Adjusted gMean Ratio|108.55|STANDARD_ERROR_OF_MEAN|10.7|||TWO_SIDED|90.0|100.68|117.03|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|117.03|100.68|
71066732|NCT03307252|141642153|OTHER||Adjusted gMean Ratio|348.06|STANDARD_ERROR_OF_MEAN|21.5|||TWO_SIDED|90.0|299.64|404.31|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|404.31|299.64|
71066733|NCT03307252|141642154|OTHER||Adjusted geometric mean (gMean) ratio|125.61|STANDARD_ERROR_OF_MEAN|13.2|||TWO_SIDED|90.0|113.99|138.43|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|138.43|113.99|
71066734|NCT03307252|141642154|OTHER||Adjusted gMean ratio|101.21|STANDARD_ERROR_OF_MEAN|9.2|||TWO_SIDED|90.0|94.59|108.3|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|108.30|94.59|
71066735|NCT03307252|141642154|OTHER||Adjusted gMean Ratio|130.94|STANDARD_ERROR_OF_MEAN|13.6|||TWO_SIDED|90.0|119.82|143.1|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|143.10|119.82|
71066736|NCT03307252|141642154|OTHER||Adjusted gMean Ratio|107.42|STANDARD_ERROR_OF_MEAN|12.9|||TWO_SIDED|90.0|97.57|118.27|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|118.27|97.57|
71066737|NCT03307252|141642155|OTHER||Adjusted geometric mean (gMean) ratio|106.78|STANDARD_ERROR_OF_MEAN|15.5|||TWO_SIDED|90.0|96.51|118.15|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|118.15|96.51|
71112016|NCT00997984|141730778|SUPERIORITY_OR_OTHER_LEGACY|||||||0.531||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.531
71066738|NCT03307252|141642155|OTHER||Adjusted gMean ratio|271.63|STANDARD_ERROR_OF_MEAN|15.9|||TWO_SIDED|90.0|246.74|299.03|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|299.03|246.74|
71112017|NCT00997984|141730778|SUPERIORITY_OR_OTHER_LEGACY|||||||0.226||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.226
71112018|NCT00997984|141730779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.859||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||0.859
71112019|NCT00997984|141730779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.527||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||0.527
71112020|NCT00997984|141730779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.739||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||0.739
71112021|NCT00997984|141730780|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||<0.001
70938460|NCT01020487|141377221|SUPERIORITY_OR_OTHER||Differenbce|-72.4|||<|0.001|TWO_SIDED|95.0|-108.05|-36.75|||Mixed Models Analysis|||Overall Comparison (all time points): A mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.||-36.75|-108.05|< 0.001
70938461|NCT01020487|141377221|SUPERIORITY_OR_OTHER||Difference|-62.55||||0.006|TWO_SIDED|95.0|-105.6|-19.49|||Mixed Models Analysis|||Week 2 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.||-19.49|-105.60|0.006
71066739|NCT03307252|141642155|OTHER||Adjusted gMean Ratio|100.8|STANDARD_ERROR_OF_MEAN|9.6|||TWO_SIDED|90.0|94.62|107.39|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|107.39|94.62|
71066740|NCT03307252|141642155|OTHER||Adjusted gMean Ratio|223.24|STANDARD_ERROR_OF_MEAN|13.9|||TWO_SIDED|90.0|203.79|244.55|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|244.55|203.79|
71066741|NCT03307252|141642156|OTHER||Adjusted geometric mean (gMean) ratio|121.64|STANDARD_ERROR_OF_MEAN|27.7|||TWO_SIDED|90.0|100.43|147.33|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|147.33|100.43|
71066742|NCT03307252|141642156|OTHER||Adjusted gMean ratio|95.18|STANDARD_ERROR_OF_MEAN|19.6|||TWO_SIDED|90.0|83.03|109.11|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|109.11|83.03|
71066743|NCT03307252|141642156|OTHER||Adjusted gMean Ratio|80.19|STANDARD_ERROR_OF_MEAN|13.4|||TWO_SIDED|90.0|73.01|88.08|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|88.08|73.01|
71066744|NCT03307252|141642156|OTHER||Adjusted gMean Ratio|115.39|STANDARD_ERROR_OF_MEAN|30.1|||TWO_SIDED|90.0|93.8|141.94|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|141.94|93.80|
71066745|NCT03307252|141642157|OTHER||Adjusted geometric mean (gMean) ratio|218.26|STANDARD_ERROR_OF_MEAN|27.7|||TWO_SIDED|90.0|180.19|264.36|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|264.36|180.19|
71066746|NCT03307252|141642157|OTHER||Adjusted gMean ratio|135.07|STANDARD_ERROR_OF_MEAN|19.6|||TWO_SIDED|90.0|117.83|154.84|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|154.84|117.83|
71112022|NCT00997984|141730780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.004
71112023|NCT00997984|141730780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.001
71112024|NCT01763333|141730828|SUPERIORITY_OR_OTHER||Slope|0.8728|||||TWO_SIDED|95.0|0.6942|1.0513|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose). Dose proportionality of tablets for Cmax was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.||1.0513|0.6942|
71117671|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
70941788|NCT04748445|141383935|OTHER||Slope|0.00007327|STANDARD_ERROR_OF_MEAN|6.63||0.2713|TWO_SIDED|90.0|-0.0000366|0.0001831|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-5).||0.0001831|-0.0000366|0.2713
71066747|NCT03307252|141642157|OTHER||Adjusted gMean Ratio|112.31|STANDARD_ERROR_OF_MEAN|13.4|||TWO_SIDED|90.0|102.26|123.35|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|123.35|102.26|
71066748|NCT03307252|141642157|OTHER||Adjusted gMean Ratio|1125.1|STANDARD_ERROR_OF_MEAN|30.1|||TWO_SIDED|90.0|914.63|1384.0|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|1384.00|914.63|
71066749|NCT03307252|141642158|OTHER||Adjusted geometric mean (gMean) ratio|218.26|STANDARD_ERROR_OF_MEAN|27.7|||TWO_SIDED|90.0|180.19|264.36|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|264.36|180.19|
71066750|NCT03307252|141642158|OTHER||Adjusted gMean ratio|104.78|STANDARD_ERROR_OF_MEAN|21.0|||TWO_SIDED|90.0|89.97|122.03|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|122.03|89.97|
71066751|NCT03307252|141642158|OTHER||Adjusted gMean Ratio|122.65|STANDARD_ERROR_OF_MEAN|20.1|||TWO_SIDED|90.0|107.68|139.69|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|139.69|107.68|
71066752|NCT03307252|141642158|OTHER||Adjusted gMean Ratio|116.88|STANDARD_ERROR_OF_MEAN|14.4|||TWO_SIDED|90.0|105.07|130.03|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|130.03|105.07|
71066753|NCT03307252|141642159|OTHER||Adjusted geometric mean (gMean) ratio|87.07|STANDARD_ERROR_OF_MEAN|20.9|||TWO_SIDED|90.0|76.08|99.64|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|99.64|76.08|
71066754|NCT03307252|141642159|OTHER||Adjusted gMean ratio|122.94|STANDARD_ERROR_OF_MEAN|18.0|||TWO_SIDED|90.0|110.25|137.09|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|137.09|110.25|
71066755|NCT03307252|141642159|OTHER||Adjusted gMean Ratio|101.35|STANDARD_ERROR_OF_MEAN|12.0|||TWO_SIDED|90.0|93.65|109.7|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|109.70|93.65|
71066756|NCT03307252|141642159|OTHER||Adjusted gMean Ratio|428.23|STANDARD_ERROR_OF_MEAN|26.8|||TWO_SIDED|90.0|359.78|509.7|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|509.70|359.78|
71078588|NCT01240902|141665057|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier|26.0|STANDARD_ERROR_OF_MEAN|2.0|<|0.0001|TWO_SIDED|95.0|22.3|30.1|||z-test, 1 sided||Kaplan-Meier Event Rate Greenwood Standard Error|TAVR with the Medtronic CoreValve System meets the Performance Goal in the 12 month rate of all-cause mortality or major stroke H0: = πMCS TAVI ≥ 43.0% HA: = πMCS TAVI \< 43.0% In the above expressions πMCS TAVI denotes the rate of all-cause mortality or major stroke during a fixed follow-up of 1 year.||30.1|22.3|<0.0001
71078589|NCT01240902|141665057|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier|39.3|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED||||||||Kaplan-Meier Event Rate Greenwood Standard Error|No performance goal created, only descriptive statistics are provided.||||
71078590|NCT01240902|141665057|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The 12 month all-cause mortality estimated rate was 20% for each group with a noninferiority margin of 7.5 percentage points. Assuming a 1:1 ratio in the treatment assignments, we estimated that a total of 355 patients were required in each group for the study to have power of 80% at a one-sided alpha level of 0.05. Accounting for a 10% loss to follow-up, we calculated that we would need to enroll 790 patients.|||||<|0.0001|TWO_SIDED||||||z-test, 1 sided|||||||<0.0001
70938462|NCT01020487|141377221|SUPERIORITY_OR_OTHER||Difference|-68.43||||0.032|TWO_SIDED|95.0|-130.39|-6.47|||Mixed Models Analysis|||Week 4 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.||-6.47|-130.39|0.032
70938463|NCT01020487|141377221|SUPERIORITY_OR_OTHER||Difference|-70.09||||0.043|TWO_SIDED|95.0|-137.82|-2.37|||Mixed Models Analysis|||Week 8 Comparison: A mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.||-2.37|-137.82|0.043
70938464|NCT01020487|141377221|SUPERIORITY_OR_OTHER||Difference|-88.52||||0.002|TWO_SIDED|95.0|-142.04|-35.01|||Mixed Models Analysis|||Week 12 Comparison: A mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.||-35.01|-142.04|0.002
70938465|NCT01020487|141377222|SUPERIORITY_OR_OTHER|||||||0.327|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CHM) test, adjusting for CKD Stage.||||||0.327
70938466|NCT01020487|141377223|SUPERIORITY_OR_OTHER|||||||0.194|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CHM) test, adjusting for CKD Stage.||||||0.194
70938467|NCT01020487|141377224|SUPERIORITY_OR_OTHER||Difference|0.14||||0.469|TWO_SIDED|95.0|-0.25|0.53|||Mixed Models Analysis|||Overall Comparison (all time points): a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement||0.53|-0.25|0.469
70938468|NCT01020487|141377224|SUPERIORITY_OR_OTHER||Difference|-0.01||||0.975|TWO_SIDED|95.0|-0.39|0.37|||Mixed Models Analysis|||Week 4 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.||0.37|-0.39|0.975
70852721|NCT01578850|141194336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.54||||0.004|TWO_SIDED|95.0|-5.97|-1.12|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Week 36||-1.12|-5.97|0.004
70938469|NCT01020487|141377224|SUPERIORITY_OR_OTHER||Difference|0.12||||0.567|TWO_SIDED|95.0|-0.32|0.56|||Mixed Models Analysis|||Week 8 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement||0.56|-0.32|0.567
71066757|NCT03307252|141642160|OTHER||Adjusted gMean ratio|92.24|STANDARD_ERROR_OF_MEAN|11.2|||TWO_SIDED|90.0|85.28|99.76|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|99.76|85.28|
71066758|NCT03307252|141642160|OTHER||Adjusted gMean Ratio|83.99|STANDARD_ERROR_OF_MEAN|10.0|||TWO_SIDED|90.0|78.32|90.08|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|90.08|78.32|
71066759|NCT03307252|141642160|OTHER||Adjusted gMean Ratio|124.06|STANDARD_ERROR_OF_MEAN|23.9|||TWO_SIDED|90.0|105.11|146.43|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|146.43|105.11|
70852722|NCT01578850|141194336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.33|||<|0.001|TWO_SIDED|95.0|-6.78|-1.88|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Week 44||-1.88|-6.78|<0.001
70938470|NCT01020487|141377224|SUPERIORITY_OR_OTHER||Difference|0.3||||0.462|TWO_SIDED|95.0|-0.53|1.12|||Mixed Models Analysis|||Week 12 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement||1.12|-0.53|0.462
70938471|NCT01366976|141377232|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Mixed Models Analysis|||We hypothesized that acetaminophen would reduce peak isofuran concentrations by 22 pg/mL (40% reduction from peak concentrations). If the true difference in the acetaminophen and placebo group means is 22 pg/mL (SD=30 pg/mL), we would need to study 30 experimental subjects and 30 control subjects to be able to reject the null hypothesis that the population means of the acetaminophen and placebo groups are equal with probability (power) 0.8.||||0.05
70938472|NCT01366976|141377234|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Mixed Models Analysis|||||||0.12
70938473|NCT00307489|141377252|SUPERIORITY_OR_OTHER|||||||0.544||95.0||||P-values were from a Cochran-Mantel-Haenszel test, controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||.544
70938474|NCT00307489|141377253|SUPERIORITY_OR_OTHER|||||||0.208||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|van Elteren|||||||0.208
70938475|NCT00307489|141377254|SUPERIORITY_OR_OTHER|||||||0.712||95.0||||Controlling for baseline HBeAg and prior lamivudine use.|van Elteren|||||||0.712
70938476|NCT00307489|141377255|SUPERIORITY_OR_OTHER|||||||0.988||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.988
70938477|NCT00307489|141377256|SUPERIORITY_OR_OTHER|||||||0.423||95.0||||Controlling for baseline HBeAg status and prior lamivudine use|Cochran-Mantel-Haenszel|||||||0.423
70938478|NCT00307489|141377257|SUPERIORITY_OR_OTHER|||||||0.109||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.109
71066760|NCT03307252|141642161|OTHER||Adjusted gMean Ratio|112.73|STANDARD_ERROR_OF_MEAN|11.2|||TWO_SIDED|90.0|104.23|121.92|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|121.92|104.23|
71066761|NCT03307252|141642161|OTHER||Adjusted gMean Ratio|108.56|STANDARD_ERROR_OF_MEAN|10.0|||TWO_SIDED|90.0|101.22|116.43|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|116.43|101.22|
71066762|NCT03307252|141642161|OTHER||Adjusted gMean Ratio|340.67|STANDARD_ERROR_OF_MEAN|23.9|||TWO_SIDED|90.0|288.63|402.1|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|402.10|288.63|
71066763|NCT03307252|141642162|OTHER||Adjusted gMean ratio|100.78|STANDARD_ERROR_OF_MEAN|10.0|||TWO_SIDED|90.0|93.59|108.51|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|108.51|93.59|
71066764|NCT03307252|141642162|OTHER||Adjusted gMean Ratio|131.37|STANDARD_ERROR_OF_MEAN|13.4|||TWO_SIDED|90.0|120.37|143.37|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|143.37|120.37|
71066765|NCT03307252|141642162|OTHER||Adjusted gMean Ratio|106.55|STANDARD_ERROR_OF_MEAN|12.8|||TWO_SIDED|90.0|96.87|117.19|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|117.19|96.87|
71066766|NCT03307252|141642163|OTHER||Adjusted gMean ratio|260.11|STANDARD_ERROR_OF_MEAN|14.7|||TWO_SIDED|90.0|237.96|284.32|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|284.32|237.96|
71066767|NCT03307252|141642163|OTHER||Adjusted gMean Ratio|101.21|STANDARD_ERROR_OF_MEAN|9.4|||TWO_SIDED|90.0|95.15|107.66|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|107.66|95.15|
71066768|NCT03307252|141642163|OTHER||Adjusted gMean Ratio|215.28|STANDARD_ERROR_OF_MEAN|13.1|||TWO_SIDED|90.0|197.53|234.63|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|234.63|197.53|
71066769|NCT02157376|141642175|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the two-sided 95% confidence interval for the difference is larger than -0.05, the non-inferiority claim will be met.|Risk Difference (RD)|1.9||||0.393|TWO_SIDED|95.0|-2.8|6.5|||Pearson's Chi-square||The difference in treatment group percentages is given by Cimetidine minus Esomeprazole.|Assuming a bleeding percent of 6.3% for the active comparator, a risk reduction of 3.7% for esomeprazole, and a 5% non-inferiority margin, 150 patients per treatment arm will provide 94% power to demonstrate non-inferiority. The null hypothesis is that the bleeding rate for iv esomeprazole 40 mg bid exceeds the rate for iv cimetidine by an amount at least as large as 5%.||6.5|-2.8|0.393
70938479|NCT00307489|141377258|SUPERIORITY_OR_OTHER|||||||0.952||95.0|||||Cochran-Mantel-Haenszel|Controlling for baseline HBeAg and prior lamivudine use.||||||0.952
70938480|NCT00307489|141377259|SUPERIORITY_OR_OTHER|||||||0.655||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.655
70938481|NCT00307489|141377260|SUPERIORITY_OR_OTHER|||||||0.401||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.401
70938482|NCT00307489|141377261|SUPERIORITY_OR_OTHER|||||||0.401||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.401
70938483|NCT00307489|141377262|SUPERIORITY_OR_OTHER|||||||0.103||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|van Elteren|||||||0.103
70938484|NCT00307489|141377263|SUPERIORITY_OR_OTHER|||||||0.999||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|van Elteren|||||||0.999
70938485|NCT00307489|141377264|SUPERIORITY_OR_OTHER|||||||0.781||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.781
71066770|NCT01578239|141642194|SUPERIORITY||Hazard Ratio (HR)|0.177|||<|0.0001|TWO_SIDED|95.0|0.108|0.289||Derived from a two-sided test between the two groups|Log Rank||Hazard ratio is expressed as Lu-DOTA-Tyr-Octreotate / Octreotide LAR and estimated from the corresponding Cox model.|||0.289|0.108|<0.0001
71066771|NCT01578239|141642195|SUPERIORITY|||||||0.0141|||||||Fisher Exact|||||||0.0141
70938486|NCT00307489|141377265|SUPERIORITY_OR_OTHER|||||||0.936||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.936
71066772|NCT01578239|141642196|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.3039|TWO_SIDED|95.0|0.6|1.17|||Log Rank|||||1.17|0.60|0.3039
71066773|NCT01578239|141642197|SUPERIORITY||Cox Proportional Hazard|0.84||||0.3039|TWO_SIDED|95.0|0.6|1.17|||Log Rank||Hazard Ratio of Lu-DOTA-Tyr-Octreotate vs. Octreotide LAR|||1.17|0.60|0.3039
71066774|NCT01578239|141642198|SUPERIORITY||Hazard Ratio (HR)|0.137|||<|0.0001|TWO_SIDED|95.0|0.077|0.242|||Log Rank|||||0.242|0.077|<0.0001
71066775|NCT01031680|141642212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.0473|<|0.0001|TWO_SIDED|95.0|-0.56|-0.37||Significant at alpha=0.025 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|ANCOVA|with treatment group and stratum as effects and baseline value as covariate for each endpoint|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.37|-0.56|<0.0001
71066776|NCT01031680|141642213|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.9|||<|0.0001|TWO_SIDED|95.0|7.0|12.9||Significant at alpha=0.025 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|Cochran-Mantel-Haenszel|with age-by-insulin use-by-time from most recent qualifying CV event as stratum||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||12.9|7.0|<0.0001
71066777|NCT01031680|141642214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.97|STANDARD_ERROR_OF_MEAN|0.7898||0.0126|TWO_SIDED|95.0|-3.52|-0.42||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.42|-3.52|0.0126
71112025|NCT01763333|141730828|SUPERIORITY_OR_OTHER||Slope|0.9341|||||TWO_SIDED|95.0|0.8277|1.0405|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose). Dose proportionality of solution for Cmax was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.||1.0405|0.8277|
71112026|NCT01763333|141730828|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|112.74|||||TWO_SIDED|90.0|95.579|132.993|||||Adjusted gMean ratio.|Relative bioavailability comparison Tab. fed (T1): Tab. fasted (R1) for Cmax. The per protocol set for the evaluation of relative bioavailability of T1 vs R1 (PPS-BA-T1-R1) was used.||132.993|95.579|
71112027|NCT01763333|141730828|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|52.66|||||TWO_SIDED|90.0|40.488|68.499|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2) : Sol. fasted (R2) for Cmax. The per protocol set for the evaluation of relative bioavailability of T2 vs R2 (PPS-BA-T2-R2) was used.||68.499|40.488|
71117740|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-2.51||||0.721|TWO_SIDED|95.0|-16.2|11.18||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.18|-16.20|0.721
71117741|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|0.44||||0.951|TWO_SIDED|95.0|-13.47|14.35||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.35|-13.47|0.951
71117742|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-29.13||||0.005|TWO_SIDED|95.0|-46.66|-11.59||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-11.59|-46.66|0.005
70938487|NCT00307489|141377266|SUPERIORITY_OR_OTHER|||||||0.784||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.784
71066778|NCT01031680|141642215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.27|STANDARD_ERROR_OF_MEAN|0.191|<|0.0001||95.0|-2.64|-1.89||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.89|-2.64|<0.0001
71066779|NCT01031680|141642216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.95|STANDARD_ERROR_OF_MEAN|0.8203||0.0174|TWO_SIDED|95.0|-3.56|-0.34||Significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.34|-3.56|0.0174
71066780|NCT01031680|141642217|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.5|STANDARD_ERROR_OF_MEAN|2.126|<|0.0001|TWO_SIDED|95.0|8.3|16.6||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value and stratum (gender)||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||16.6|8.3|<0.0001
71066781|NCT01921101|141642226|SUPERIORITY_OR_OTHER|||||||0.29|||||||Chi-squared|||||||0.29
71066782|NCT01483027|141642231|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0013|TWO_SIDED|95.0|0.54|0.88|||Log Rank|||Analysis performed using a log-rank test||0.88|0.54|0.0013
71066783|NCT01483027|141642232|SUPERIORITY||Hazard Ratio (HR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.46|0.77|||Log Rank|||Analysis performed using a log-rank test.||0.77|0.46|<0.0001
71066784|NCT00652626|141642288|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|98.4|||||TWO_SIDED|90.0|64.0|151.3|||||Ratio of geometric means is calculated as Azacitidine 50 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% confidence interval (CI) of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-t, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons||151.3|64.0|
71066785|NCT00652626|141642288|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|67.5|||||TWO_SIDED|90.0|44.7|101.8|||||Ratio of geometric means is calculated as Azacitidine 75 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-t, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons||101.8|44.7|
71066786|NCT00652626|141642288|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|82.7|||||TWO_SIDED|90.0|53.8|127.2|||||Ratio of geometric means is calculated as Azacitidine 100 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-t, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons||127.2|53.8|
71066787|NCT00652626|141642289|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|97.4|||||TWO_SIDED|90.0|63.8|148.8|||||Ratio of geometric mean is calculated as Azacitidine 50 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-inf, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons.||148.8|63.8|
71066788|NCT00652626|141642289|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|68.5|||||TWO_SIDED|90.0|45.7|102.7|||||Ratio of geometric mean is calculated as Azacitidine 75 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-inf, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons.||102.7|45.7|
71066789|NCT00652626|141642289|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|83.2|||||TWO_SIDED|90.0|54.5|127.1|||||Ratio of geometric mean is calculated as Azacitidine 100 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-inf, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons.||127.1|54.5|
71066790|NCT00652626|141642290|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|127.7|||||TWO_SIDED|90.0|66.3|245.7|||||Ratio of geometric means is calculated as Azacitidine 50 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized Cmax, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons||245.7|66.3|
71066791|NCT00652626|141642290|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|84.7|||||TWO_SIDED|90.0|45.3|158.5|||||Ratio of geometric means is calculated as Azacitidine 75 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized Cmax, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons||158.5|45.3|
71066792|NCT00652626|141642290|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|107.5|||||TWO_SIDED|90.0|55.9|207.0|||||Ratio of geometric means is calculated as Azacitidine 100 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized Cmax, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons||207.0|55.9|
70938488|NCT00307489|141377267|SUPERIORITY_OR_OTHER|||||||0.703||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.703
70938489|NCT00307489|141377268|SUPERIORITY_OR_OTHER|||||||0.254||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.254
70938490|NCT00307489|141377269|SUPERIORITY_OR_OTHER|||||||0.254||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.254
70938491|NCT00307489|141377270|SUPERIORITY_OR_OTHER|||||||0.878||95.0|||||Cochran-Mantel-Haenszel|||||||0.878
70938492|NCT02964234|141377282|SUPERIORITY||Odds Ratio (OR)|10.59||||0.005|TWO_SIDED|95.0|2.01|56.31||We clustered by cohort, given both interventions used a group format, and adjusted for age, socioeconomic status (education, income, insurance status) baseline mammography history, and baseline mammography intention.|Regression, Logistic|||We conducted logistic regressions, clustering by cohort, given both interventions used a group format, and adjusting for age, education, income, insurance status, baseline mammography history, and baseline mammography intention. The null hypothesis was there would be no study arm differences. A priori power analysis suggested that a sample size of 150, assuming alpha = .05, power = .80 would lead us to detect medium/large effects (OR = 2.8).||56.31|2.01|.005
70938493|NCT02964234|141377283|SUPERIORITY||Slope|-0.19||||0.03|TWO_SIDED|95.0|-0.34|-0.04|||Regression, Linear|With GEE. Models had exchangeable correlation structure, a gamma distribution, and log link.||Analyses were conducted using GEE with an exchangeable correlation structure and a gamma distribution with log link. All models included study arm, time, and the study arm\*time. Covariates included age, education, and mammography history. With 150 Latinas, alpha = 0.05, power = 0.80, ICC = 0.0-0.05, we expected to detect small/medium interaction effects.||-0.04|-0.34|0.03
71066793|NCT00652626|141642293|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|101.1|||||TWO_SIDED|90.0|71.2|143.6|||||Ratio of geometric mean is calculated as Azacitidine 50 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance model on the nature log-transformed CL/F obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons.||143.6|71.2|
71066794|NCT00652626|141642293|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|144.9|||||TWO_SIDED|90.0|103.6|202.7|||||Ratio of geometric mean is calculated as Azacitidine 75 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance model on the nature log-transformed CL/F obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons.||202.7|103.6|
71066795|NCT00652626|141642293|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|101.4|||||TWO_SIDED|90.0|71.4|143.9|||||Ratio of geometric mean is calculated as Azacitidine 100 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance model on the nature log-transformed CL/F obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons.||143.9|71.4|
71066796|NCT00652626|141642296|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|169.3|||||TWO_SIDED|90.0|109.2|262.5|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of AUC0-t after a single dose (Day 1) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters"||262.5|109.2|
71066797|NCT00652626|141642296|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|140.4|||||TWO_SIDED|90.0|90.6|217.7|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of AUC0-t after multiple doses (Day 5) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters."||217.7|90.6|
71066798|NCT00652626|141642297|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|166.3|||||TWO_SIDED|90.0|108.6|254.6|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of AUC0-inf after a single dose (Day 1) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters."||254.6|108.6|
71066799|NCT00652626|141642297|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|141.2|||||TWO_SIDED|90.0|92.2|216.2|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of AUC0-inf after multiple doses (Day 5) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters."||216.2|92.2|
71066800|NCT00652626|141642298|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|141.7|||||TWO_SIDED|90.0|73.2|274.6|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of Cmax after a single dose (Day 1) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters."||274.6|73.2|
71066801|NCT00652626|141642298|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|105.6|||||TWO_SIDED|90.0|54.5|204.6|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of Cmax after multiple doses (Day 5) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters."||204.6|54.5|
71066802|NCT00652626|141642299|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.25||||0.1342|TWO_SIDED|90.0|0.0|0.52|||Wilcoxon (Mann-Whitney)||Median difference is Severe RI - Normal RF.|Comparison of Tmax after a single dose (Day 1) in participants with normal renal function and participants with severe renal impairment.||0.52|0|0.1342
71066803|NCT00652626|141642299|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.25||||0.1017|TWO_SIDED|90.0|0.0|0.5|||Wilcoxon (Mann-Whitney)||Median difference is Severe RI - Normal RF.|Comparison of Tmax after multiple doses (Day 5) in participants with normal renal function and participants with severe renal impairment.||0.50|0|0.1017
71066804|NCT02898597|141642310|SUPERIORITY||Odds Ratio (OR)|12.31|||<|0.05|TWO_SIDED|95.0|1.37|110.3|||Regression, Logistic|||||110.30|1.37|< 0.05
71066805|NCT02898597|141642310|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||Fisher Exact test was performed, comparing the proportion of participants whose abstinence was verified with salivary cotinine test between the two arms, which was significant (p = 0.02).||||<0.05
71066806|NCT01234870|141642323|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The MR images resulting from two different image acquisition techniques, including Non-Corrected Breath-Hold Shallow-Breathing and Motion-Corrected, were assessed independently by two radiologists (average of 7 years of experience in reading cardiac MRI) using the American Heart Association modified 16 segment model and were evaluated using a four point Likert scale (1 = poor, 2 = fair, 3 = good, and 4 = excellent) for image quality||||<0.001
71066807|NCT01262287|141642347|SUPERIORITY_OR_OTHER|||||||0.9|||||||t-test, 2 sided|||||||0.9
71066808|NCT01262287|141642348|SUPERIORITY_OR_OTHER|||||||0.9|||||||t-test, 2 sided|||||||0.9
71066809|NCT01262287|141642348|SUPERIORITY_OR_OTHER|||||||0.9|||||||t-test, 2 sided|||||||0.9
71066810|NCT01637922|141642359|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|118.12|STANDARD_DEVIATION|15.4||0.1638|TWO_SIDED|90.0|107.06|130.32||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. Methadone(MTD) alone on Day 1||130.32|107.06|0.1638
71066811|NCT01637922|141642360|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|114.08|STANDARD_DEVIATION|13.2||0.0391|TWO_SIDED|90.0|104.812|124.164||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. Methadone(MTD) alone on Day 1||124.164|104.812|0.0391
71066812|NCT01637922|141642361|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|111.79|STANDARD_DEVIATION|18.7||0.0603|TWO_SIDED|90.0|99.243|125.922||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. Methadone(MTD) alone on Day 1||125.922|99.243|0.0603
71066813|NCT01637922|141642362|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|117.65|STANDARD_DEVIATION|15.0||0.1424|TWO_SIDED|90.0|106.89|129.5||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|S-Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. S-Methadone(MTD) alone on Day 1||129.50|106.89|0.1424
71066814|NCT01637922|141642363|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|111.46|STANDARD_DEVIATION|16.3||0.0367|TWO_SIDED|90.0|100.42|123.715||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|S-Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. S-Methadone(MTD) alone on Day 1||123.715|100.420|0.0367
71066815|NCT01637922|141642364|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|111.52|STANDARD_DEVIATION|17.7||0.0488|TWO_SIDED|90.0|99.577|124.888||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|S-Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. S-Methadone(MTD) alone on Day 1||124.888|99.577|0.0488
71066816|NCT01637922|141642365|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.01098|||||TWO_SIDED|95.0|-0.189801|0.16864||||||Pearson correlation of trough concentrations of R-methadone and OOWS||0.168640|-0.189801|
71066817|NCT01637922|141642365|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.10188|||||TWO_SIDED|95.0|-0.287471|0.092062||||||Pearson correlation of change from baseline for trough concentrations of R-methadone and OOWS||0.092062|-0.287471|
70938494|NCT02964234|141377284|SUPERIORITY||Odds Ratio (OR)|6.15|||<|0.0001|TWO_SIDED|95.0|2.82|13.32||Analyses clustered by cohort and adjusted for age, SES (education, income, insurance), mammography history, mammography intention, and baseline supportive breast cancer social network size.|Ordinal regression|||We used ordinal regression, given the non-normal distribution revealed by preliminary analyses. Analyses clustered by cohort and adjusted for age, SES (education, income, insurance), mammography history, mammography intention, and baseline supportive breast cancer social network size. Power analyses suggested that with 150 Latinas, alpha = .05, power = .80, we would be able to detect a small effect (Cohen's f = 0.05).||13.32|2.82|<0.0001
71066818|NCT01637922|141642365|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.03198|||||TWO_SIDED|95.0|-0.209893|0.148238||||||Pearson correlation of trough concentrations of S-methadone and OOWS||0.148238|-0.209893|
71066819|NCT01637922|141642365|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.0026|||||TWO_SIDED|95.0|-0.189172|0.194156||||||Pearson correlation of change from baseline for trough concentrations of S-methadone and OOWS||0.194156|-0.189172|
71066820|NCT01637922|141642365|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.03364|||||TWO_SIDED|95.0|-0.214505|0.149733||||||Pearson correlation of trough concentrations of Buprenorphine and OOWS||0.149733|-0.214505|
71066821|NCT01637922|141642365|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.14703|||||TWO_SIDED|95.0|-0.404929|0.135425||||||Pearson correlation of change from baseline for trough concentrations of Buprenorphine and OOWS||0.135425|-0.404929|
71066822|NCT01637922|141642365|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.05431|||||TWO_SIDED|95.0|-0.240578|0.136305||||||Pearson correlation of trough concentrations of norbuprenorphine and OOWS||0.136305|-0.240578|
71066823|NCT01637922|141642365|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.09727|||||TWO_SIDED|95.0|-0.344024|0.163687||||||Pearson correlation of change from baseline for trough concentrations of norbuprenorphine and OOWS||0.163687|-0.344024|
71066824|NCT01637922|141642365|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.36105|||||||||||||Confidence interval is not provided due to sparse data. There was only 1 patient for this analysis.|Pearson correlation of trough concentrations of naloxone and OOWS||||
71066825|NCT01637922|141642366|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|108.71|STANDARD_DEVIATION|36.1||0.1642|TWO_SIDED|90.0|85.14|138.8||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|BUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. BUPRENORPHINE(BUP) alone on Day 1||138.80|85.14|0.1642
71066826|NCT01637922|141642367|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|92.43|STANDARD_DEVIATION|33.7||0.142|TWO_SIDED|90.0|73.48|116.27||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|BUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. BUPRENORPHINE(BUP) alone on Day 1||116.27|73.48|0.1420
71066827|NCT01637922|141642368|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|108.36|STANDARD_DEVIATION|38.1||0.1915|TWO_SIDED|90.0|81.611|143.883||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|BUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. BUPRENORPHINE(BUP) alone on Day 1||143.883|81.611|0.1915
70852723|NCT01578850|141194336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.27|||<|0.001|TWO_SIDED|95.0|-6.7|-1.84|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Week 52||-1.84|-6.70|<0.001
71066828|NCT01637922|141642369|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.04783|||||TWO_SIDED|95.0|-0.13275|0.224946||||||Pearson correlation of trough concentrations of R-methadone and SOWS||0.224946|-0.132750|
71066829|NCT01637922|141642369|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.39865|||||TWO_SIDED|95.0|-0.547072|-0.222288||||||Pearson correlation of change from baseline for trough concentrations of R-methadone and SOWS||-0.222288|-0.547072|
71066830|NCT01637922|141642369|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.11175|||||TWO_SIDED|95.0|-0.069336|0.284848||||||Pearson correlation of trough concentrations of S-methadone and SOWS||0.284848|-0.069336|
71066831|NCT01637922|141642369|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.16815|||||TWO_SIDED|95.0|-0.34787|0.025107||||||Pearson correlation of change from baseline for trough concentrations of S-methadone and SOWS||0.025107|-0.347870|
71066832|NCT01637922|141642369|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.0126|||||TWO_SIDED|95.0|-0.17016|0.194417||||||Pearson correlation of trough concentrations of Buprenorphine and SOWS||0.194417|-0.170160|
71066833|NCT01637922|141642369|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.02352|||||TWO_SIDED|95.0|-0.253932|0.29696||||||Pearson correlation of change from baseline for trough concentrations of Buprenorphine and SOWS||0.296960|-0.253932|
71066834|NCT01637922|141642369|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.05787|||||TWO_SIDED|95.0|-0.24392|0.132819||||||Pearson correlation of trough concentrations of norbuprenorphine and SOWS||0.132819|-0.243920|
71066835|NCT01637922|141642369|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.04052|||||TWO_SIDED|95.0|-0.218159|0.293233||||||Pearson correlation of change from baseline for trough concentrations of norbuprenorphine and SOWS||0.293233|-0.218159|
71066836|NCT01637922|141642369|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.92231|||||||||||||Confidence interval is not provided due to sparse data. There was only 1 patient for this analysis.|Pearson correlation of trough concentrations of naloxone and SOWS||||
71066837|NCT01637922|141642370|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|138.0|STANDARD_DEVIATION|50.7||0.6889|TWO_SIDED|90.0|97.2|195.92||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|NORBUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. NORBUPRENORPHINE(BUP) alone on Day 1||195.92|97.20|0.6889
70938495|NCT03512041|141377292|SUPERIORITY|||||||0.172|||||||ANOVA|||||||0.172
70938496|NCT03512041|141377293|SUPERIORITY|||||||0.169|||||||ANOVA|||||||0.169
70938497|NCT03512041|141377294|SUPERIORITY|||||||0.501|||||||ANOVA|||||||0.501
70938498|NCT00828139|141377295|SUPERIORITY_OR_OTHER||3-month PFS|0.24|||||TWO_SIDED|90.0|0.14|0.37|||||The estimated value corresponds to the probability of PFS at month 3.|3-month PFS was estimated using the method of Kaplan-Meier. The 3-month PFS estimated value corresponds to the probability of PFS at month 3.||0.37|0.14|
71066838|NCT01637922|141642371|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|132.86|STANDARD_DEVIATION|51.1||0.6188|TWO_SIDED|90.0|93.32|189.16||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|NORBUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. NORBUPRENORPHINE(BUP) alone on Day 1||189.16|93.32|0.6188
71066839|NCT01637922|141642372|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|112.03|STANDARD_DEVIATION|52.5||0.3152|TWO_SIDED|90.0|74.85|167.67||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|NORBUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. NORBUPRENORPHINE(BUP) alone on Day 1||167.67|74.85|0.3152
71066840|NCT01637922|141642373|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|98.94|STANDARD_DEVIATION|19.6||0.0107|TWO_SIDED|90.0|85.81|114.076||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|NALOXONE(BUP) + Faldaprevir(FDV) on Day 9 vs. NALOXONE(BUP) alone on Day 1||114.076|85.810|0.0107
71066841|NCT01637922|141642374|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|94.33|STANDARD_DEVIATION|27.6||0.0738|TWO_SIDED|90.0|78.017|114.054||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|NALOXONE(BUP) + Faldaprevir(FDV) on Day 9 vs. NALOXONE(BUP) alone on Day 1||114.054|78.017|0.0738
71066842|NCT00638404|141642376|OTHER|correlation of anxiety, anticipated pain medication use and anticipated pain to 24 hour evoked pain measured|||||<|0.001|||||||Spearman Correlation|anxiety to evoked pain is 0.24 (P\<.001); anticipated pain to evoked pain is 0.33 (P\<.001); anticipated pain medication to evoked pain is 0.33(P\<.001).||||||<.001
71066843|NCT00638404|141642376|OTHER|correlation of anxiety to evoked pain at 24 hour|||||<|0.001|||||||Spearman Correlation|||||||<.001
71066844|NCT00638404|141642376|OTHER|correlation of anticipated pain medication 24 hour evoked pain measured|||||<|0.001|||||||Spearman Correlation|||||||<.001
71066845|NCT00638404|141642376|OTHER|correlation of anticipated pain to 24 hour evoked pain measured|||||<|0.001|||||||Spearman Correlation|||||||<.001
71112028|NCT01763333|141730828|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|239.63|||||TWO_SIDED|90.0|197.445|290.83|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fasted (R2): Tab. fasted (R1) for Cmax. The per protocol set for the evaluation of relative bioavailability of R2 vs R1 (PPS-BA-R2-R1) was used.||290.830|197.445|
70938499|NCT00828139|141377295|SUPERIORITY_OR_OTHER||3-month PFS|0.15|||||TWO_SIDED|90.0|0.07|0.27|||||The estimated value corresponds to the probability of PFS at month 3.|3-month PFS was estimated using the method of Kaplan-Meier.||0.27|0.07|
71066846|NCT00638404|141642377|OTHER||||||<|0.001|||||||Spearman Correlation|||preoperative questionnaire evaluating anticipated amount of pain medication potentially needed postoperatively; 0= none at all up to 100=as much as possible||||<.001
71066847|NCT00638404|141642378|OTHER||||||<|0.001|||||||Spearman Correlation|||||||<.001
71066848|NCT00638404|141642379|OTHER|Correlation of|||||<|0.001|||||||Spearman Correlation|||||||<.001
71066849|NCT02110758|141642391|OTHER|||||||0.025|||||||Regression, Logistic|||To estimate exposure to the intervention on the Access composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).||||.025
70938500|NCT00828139|141377295|SUPERIORITY_OR_OTHER||3-month PFS|0.27|||||TWO_SIDED|90.0|0.18|0.39|||||The estimated value corresponds to the probability of PFS at month 3.|3-month PFS was estimated using the method of Kaplan-Meier.||0.39|0.18|
70938501|NCT00828139|141377295|SUPERIORITY_OR_OTHER||3-month PFS|0.1|||||TWO_SIDED|90.0|0.04|0.2|||||The estimated value corresponds to the probability of PFS at month 3.|3-month PFS was estimated using the method of Kaplan-Meier.||0.2|0.04|
70938502|NCT00828139|141377295|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32|||||TWO_SIDED|90.0|0.91|1.92||||||Hazard Ratio was evaluated using a logrank test.||1.92|0.91|
70938503|NCT00828139|141377295|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51|||||TWO_SIDED|90.0|1.08|2.1||||||Hazard Ratio was evaluated using log-rank test.||2.10|1.08|
70941789|NCT04748445|141383935|OTHER||Slope|0.0001534|STANDARD_ERROR_OF_MEAN|9.067||0.0931|TWO_SIDED|90.0|0.00000317|0.0003037|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-5).||0.0003037|0.00000317|0.0931
71066850|NCT02110758|141642391|OTHER|||||||0.69|||||||Regression, Logistic|||To estimate exposure to the intervention on the Affective Communication composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).||||0.69
71066851|NCT02110758|141642391|OTHER|||||||0.013|||||||Regression, Logistic|||To estimate exposure to the intervention on the Shared Decision-Making composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).||||.013
71066852|NCT02110758|141642391|OTHER|||||||0.85|||||||Regression, Logistic|||To estimate exposure to the intervention on the Patient Self-Management composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).||||0.85
71066853|NCT02110758|141642391|OTHER|||||||0.013|||||||Regression, Logistic|||To estimate exposure to the intervention on the Exchanging Information composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).||||.013
71066854|NCT02110758|141642391|OTHER|||||||0.053|||||||Regression, Logistic|||To estimate exposure to the intervention on the Overall Rating of Treatment Team composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).||||.053
71066855|NCT02110758|141642393|OTHER|||||||0.2|||||||Regression, Logistic|||To estimate exposure to the intervention on Per Member Per Month Hospitalizations, we used a difference-in-differences model with fixed effects for practices. The dependent variable was Per Member Per Month Hospitalizations. The intervention effects were represented by the coefficient estimates for utilization time period (baseline or follow-up) interacted with status (pilot or comparison).||||0.2
71066856|NCT02110758|141642393|OTHER|||||||0.62|||||||Regression, Logistic|||To estimate exposure to the intervention on Per Member Per Month Emergency Department (ED) Visits, we used a difference-in-differences model with fixed effects for practices. The dependent variable was Per Member Per Month ED Visits. The intervention effects were represented by the coefficient estimates for utilization time period (baseline or follow-up) interacted with status (pilot or comparison).||||0.62
71066857|NCT02110758|141642393|OTHER|||||||0.68|||||||Regression, Logistic|||To estimate exposure to the intervention on Per Member Per Month Primary Care Visits, we used a difference-in-differences model with fixed effects for practices. The dependent variable was Per Member Per Month Primary Care Visits. The intervention effects were represented by the coefficient estimates for utilization time period (baseline or follow-up) interacted with status (pilot or comparison).||||0.68
71066858|NCT02110758|141642393|OTHER|||||||0.03|||||||Regression, Logistic|||To estimate exposure to the intervention on Per Member Per Month Specialist Visits, we used a difference-in-differences model with fixed effects for practices. The dependent variable was Per Member Per Month Specialist Visits. The intervention effects were represented by the coefficient estimates for utilization time period (baseline or follow-up) interacted with status (pilot or comparison).||||0.03
71066859|NCT02074358|141642404|SUPERIORITY_OR_OTHER||mixed effect model|425.3|||<|0.001|TWO_SIDED|95.0|219.8|630.7|||Mixed Models Analysis||Treatment B versus Treatment A|The ETP change from pre-PCC baseline was analyzed using a mixed effect model that included treatment, sequence, and period as main effects. A hierarchical analysis was conducted with comparisons beginning with the primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||630.7|219.8|<0.001
71066860|NCT02074358|141642404|SUPERIORITY_OR_OTHER||mixed effect model|90.6||||0.131|TWO_SIDED|95.0|-31.3|212.4||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for any secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||212.4|-31.3|0.131
71066861|NCT02074358|141642405|SUPERIORITY_OR_OTHER||mixed effect model|-0.21||||0.389|TWO_SIDED|95.0|-0.73|0.3||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for other secondary endpoints since a non-significant treatment difference was observed for this first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|TGA Lag Time. ETP change from pre-PCC baseline was analyzed using a mixed effect model that included treatment, sequence, and period as main effects. A hierarchical analysis was conducted with comparisons beginning with the primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||0.30|-0.73|0.389
70938504|NCT01922102|141377325|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.2|||<|0.001|TWO_SIDED|95.0|3.3|7.1||Superiority could be claimed if the corresponding one-sided p-value was ≤ 0.025/2 = 0.0125, or if both one-sided p-values were ≤ 0.025.|Cochran-Mantel-Haenszel||Differences in LS means and the two-sided 95% CIs are estimated from pairwise ANOVA (stratified) model.|2 one-sided hypotheses were tested under the Type I error rate of 0.025, using the Hochberg procedure: H01: μRanibizumab-I - μvPDT ≤ 0 vs. HA1: μRanibizumab-I - μvPDT \> 0 and H02: μRanibizumab-II - μvPDT ≤ 0 vs. HA2: μRanibizumab-II - μvPDT \> 0, where μRanibizumab-I, μRanibizumab-II and μvPDT were the means of the primary efficacy variable for ranibizumab treatment Group I, ranibizumab treatment Group II, and vPDT treatment Group III, respectively.||7.1|3.3|<0.001
71066862|NCT02074358|141642405|SUPERIORITY_OR_OTHER||mixed effect model|-0.16||||0.142|TWO_SIDED|95.0|-0.38|0.06||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|Lag Time. ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||0.06|-0.38|0.142
71066863|NCT02074358|141642405|SUPERIORITY_OR_OTHER||mixed effect model|1.35||||0.2|TWO_SIDED|95.0|-0.81|3.52||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|Time to Peak. ETP change from pre-PCC baseline was analyzed using a mixed effect model that included treatment, sequence, and period as main effects. A hierarchical analysis was conducted with comparisons beginning with the primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||3.52|-0.81|0.200
71066864|NCT02074358|141642405|SUPERIORITY_OR_OTHER||mixed effect model|4.62|||<|0.001|TWO_SIDED|95.0|2.8|6.44||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|Time to Peak. ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||6.44|2.80|<0.001
71066865|NCT02074358|141642406|SUPERIORITY_OR_OTHER||mixed effect model|21.1||||0.014|TWO_SIDED|95.0|4.9|37.2||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|The ETP change from pre-PCC baseline was analyzed using a mixed effect model that included treatment, sequence, and period as main effects. A hierarchical analysis was conducted with comparisons beginning with the primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||37.2|4.9|0.014
71066866|NCT02074358|141642406|SUPERIORITY_OR_OTHER||mixed effect model|-6.4||||0.076|TWO_SIDED|95.0|-13.5|0.8||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||0.8|-13.5|0.076
71066867|NCT02074358|141642407|SUPERIORITY_OR_OTHER||mixed effect model|0.0||||0.996|TWO_SIDED|95.0|-5.6|5.6||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|The ETP change from pre-PCC baseline was analyzed using a mixed effect model that included treatment, sequence, and period as main effects. A hierarchical analysis was conducted with comparisons beginning with the primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||5.6|-5.6|0.996
71112029|NCT01763333|141730828|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|105.47|||||TWO_SIDED|90.0|85.427|130.208|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2): Tab. fed (T1) for Cmax. The per protocol set for the evaluation of relative bioavailability of T2 vs T1 (PPS-BA-T2-T1) was used.||130.208|85.427|
71112030|NCT01763333|141730830|SUPERIORITY_OR_OTHER||Slope|0.8341|||||TWO_SIDED|95.0|0.6485|1.0198|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose).Dose proportionality of tablets for AUC0-inf was analysed.The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.||1.0198|0.6485|
71112031|NCT01763333|141730830|SUPERIORITY_OR_OTHER||Slope|0.9149|||||TWO_SIDED|95.0|0.8059|1.0239|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose).Dose proportionality of solution for AUC0-inf was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.||1.0239|0.8059|
71117743|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-34.3||||0.001|TWO_SIDED|95.0|-51.62|-16.97||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-16.97|-51.62|0.001
70941790|NCT04748445|141383936|OTHER||Slope|-1.931|STANDARD_ERROR_OF_MEAN|3.554||0.5878|TWO_SIDED|90.0|-7.82|3.958|||Mixed Models Analysis|||EE\_Entropy (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-3).||3.958|-7.820|0.5878
71066868|NCT02074358|141642407|SUPERIORITY_OR_OTHER||mixed effect model|-6.5|||<|0.001|TWO_SIDED|95.0|-9.5|-3.6||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-3.6|-9.5|<0.001
71066869|NCT02074358|141642408|SUPERIORITY_OR_OTHER||mixed effect model|-1.64|||<|0.001|TWO_SIDED|95.0|-2.16|-1.12||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|PT (Neoplastin CI+). ETP change from pre-PCC baseline was analyzed using mixed effect model that included treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-1.12|-2.16|<0.001
71066870|NCT02074358|141642408|SUPERIORITY_OR_OTHER||mixed effect model|-1.47|||<|0.001|TWO_SIDED|95.0|-1.95|-0.99||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|PT (Neoplastin CI+). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-0.99|-1.95|<0.001
71066871|NCT02074358|141642408|SUPERIORITY_OR_OTHER||mixed effect model|-2.59|||<|0.001|TWO_SIDED|95.0|-3.3|-1.89||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|PT (Recombiplastin 2G). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-1.89|-3.30|<0.001
71066872|NCT02074358|141642408|SUPERIORITY_OR_OTHER||mixed effect model|-1.89|||<|0.001|TWO_SIDED|95.0|-2.59|-1.2||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|PT (Recombiplastin 2G). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-1.20|-2.59|<0.001
70938505|NCT01922102|141377325|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.6|||<|0.001|TWO_SIDED|95.0|3.5|7.6||Superiority could be claimed if the corresponding one-sided p-value was ≤ 0.025/2 = 0.0125, or if both one-sided p-values were ≤ 0.025.|Cochran-Mantel-Haenszel||Differences in LS means and the two-sided 95% CIs are estimated from pairwise ANOVA (stratified) model.|"The following 2 one-sided hypotheses were tested under the Type I error rate of 0.025, using the Hochberg procedure:~H01: μRanibizumab-I - μvPDT ≤ 0 vs. HA1: μRanibizumab-I - μvPDT \> 0 and H02: μRanibizumab-II - μvPDT ≤ 0 vs. HA2: μRanibizumab-II - μvPDT \> 0, where μRanibizumab-I, μRanibizumab-II and μvPDT were the means of the primary efficacy variable for ranibizumab treatment Group I, ranibizumab treatment Group II, and vPDT treatment Group III, respectively."||7.6|3.5|<0.001
70941791|NCT04748445|141383936|OTHER||Slope|-1.479|STANDARD_ERROR_OF_MEAN|2.847||0.9587|TWO_SIDED|90.0|-4.866|4.57|||Mixed Models Analysis|||MM\_Entropy (The statistical data given below have exponential factor in addition to the values mentioned. For estimated value it was 10\^-4. For dispersion value, lower limit and upper limit it was 10\^-3).||4.570|-4.866|0.9587
71066873|NCT02074358|141642408|SUPERIORITY_OR_OTHER||mixed effect model|8.47|||<|0.001|TWO_SIDED|95.0|6.29|10.66||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|aPTT. The ETP change from pre-PCC baseline was analyzed using a mixed effect model and included treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||10.66|6.29|<0.001
71066874|NCT02074358|141642408|SUPERIORITY_OR_OTHER||mixed effect model|2.3|||<|0.001|TWO_SIDED|95.0|1.28|3.32||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|aPTT. ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||3.32|1.28|<0.001
71066875|NCT02074358|141642409|SUPERIORITY_OR_OTHER||mixed effect model|-0.198|||<|0.001|TWO_SIDED|95.0|-0.266|-0.13||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|INR (Neoplastin CI+). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-0.130|-0.266|<0.001
71066876|NCT02074358|141642409|SUPERIORITY_OR_OTHER||mixed effect model|-0.17|||<|0.001|TWO_SIDED|95.0|-0.229|-0.111||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|INR (Neoplastin CI+). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-0.111|-0.229|<0.001
71066877|NCT02074358|141642409|SUPERIORITY_OR_OTHER||mixed effect model|-0.239|||<|0.001|TWO_SIDED|95.0|-0.305|-0.173||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|INR (Recombiplastin 2G). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-0.173|-0.305|<0.001
71066878|NCT02074358|141642409|SUPERIORITY_OR_OTHER||mixed effect model|-0.176|||<|0.001|TWO_SIDED|95.0|-0.242|-0.11||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|INR (Recombiplastin 2G). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-0.110|-0.242|<0.001
71066879|NCT02074358|141642410|SUPERIORITY_OR_OTHER||mixed effect models|-0.239||||0.204|TWO_SIDED|95.0|-0.625|0.146||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|Anti-Xa Activity. ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||0.146|-0.625|0.204
71066880|NCT02074358|141642410|SUPERIORITY_OR_OTHER||mixed effect models|-0.17||||0.114|TWO_SIDED|95.0|-0.389|0.048||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|Anti-Xa Activity. ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||0.048|-0.389|0.114
71066881|NCT02074358|141642420|SUPERIORITY_OR_OTHER||mixed effect model|1.039|||||TWO_SIDED|90.0|0.972|1.111|||||Treatment B versus Treatment A|Analysis used a linear mixed effect model including treatment, period, and sequence as fixed effects and within-participant measurements as repeated measures. Point estimates and 90% confidence intervals (CIs) for differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale between each PCC treatment and placebo (ie, Treatment B versus Treatment A, and Treatment C versus Treatment A). No adjustment was made for multiplicity.||1.111|0.972|
71066882|NCT02074358|141642420|SUPERIORITY_OR_OTHER||mixed effect model|1.021|||||TWO_SIDED|90.0|0.938|1.112|||||Treatment C versus Treatment A|Analysis used a linear mixed effect model including treatment, period, and sequence as fixed effects and within-participant measurements as repeated measures. Point estimates and 90% confidence intervals (CIs) for differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale between each PCC treatment and placebo (ie, Treatment C versus Treatment A). No adjustment was made for multiplicity.||1.112|0.938|
71066883|NCT02074358|141642422|SUPERIORITY_OR_OTHER||mixed effect model|1.019|||||TWO_SIDED|90.0|0.955|1.087|||||Treatment B versus Treatment A|Analysis used a linear mixed effect model including treatment, period, and sequence as fixed effects and within-participant measurements as repeated measures. Point estimates and 90% confidence intervals (CIs) for differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale between each PCC treatment and placebo (ie, Treatment B versus Treatment A). No adjustment was made for multiplicity.||1.087|0.955|
71066884|NCT02074358|141642422|SUPERIORITY_OR_OTHER||mixed effect model|1.018|||||TWO_SIDED|90.0|0.94|1.102|||||Treatment C versus Treatment A|Analysis used a linear mixed effect model including treatment, period, and sequence as fixed effects and within-participant measurements as repeated measures. Point estimates and 90% confidence intervals (CIs) for differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale between each PCC treatment and placebo (ie, Treatment C versus Treatment A). No adjustment was made for multiplicity.||1.102|0.940|
71066885|NCT01164579|141642432|SUPERIORITY_OR_OTHER||Difference in least squares (LS) Mean|-0.63|STANDARD_ERROR_OF_MEAN|0.57||0.2696|TWO_SIDED|90.0|-1.58|0.31||2-sided p-value; alpha equals (=) 0.10|mixed model repeated measures analysis|||||0.31|-1.58|0.2696
71066886|NCT01164579|141642432|SUPERIORITY_OR_OTHER||Difference in LS Mean|-0.52|STANDARD_ERROR_OF_MEAN|0.57||0.3561|TWO_SIDED|90.0|-1.46|0.41||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||||0.41|-1.46|0.3561
71066887|NCT01164579|141642433|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.55|STANDARD_ERROR_OF_MEAN|0.59||0.0089|TWO_SIDED|90.0|-2.52|-0.58||2-sided p-value; alpha= 0.10|mixed model repeated measures analysis|||||-0.58|-2.52|0.0089
71066888|NCT01164579|141642433|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.74|STANDARD_ERROR_OF_MEAN|0.59||0.0038|TWO_SIDED|90.0|-2.72|-0.76||2-sided p-value; alpha= 0.10|mixed model repeated measures analysis|||||-0.76|-2.72|0.0038
71066889|NCT01164579|141642434|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.25|STANDARD_ERROR_OF_MEAN|0.57||0.6576|TWO_SIDED|90.0|-1.19|0.69||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||0.69|-1.19|0.6576
71066890|NCT01164579|141642434|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.17|STANDARD_ERROR_OF_MEAN|0.55||0.7565|TWO_SIDED|90.0|-1.09|0.74||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||0.74|-1.09|0.7565
71112032|NCT01763333|141730830|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean Ratio|86.61|||||TWO_SIDED|90.0|76.529|98.029|||||Adjusted gMean ratio.|Relative bioavailability comparison Tab. fed (T1): Tab. fasted (R1) for AUC0-inf. The per protocol set for the evaluation of relative bioavailability of T1 vs R1 (PPS-BA-T1-R1) was used.||98.029|76.529|
71066891|NCT01164579|141642434|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.94|STANDARD_ERROR_OF_MEAN|0.58||0.1038|TWO_SIDED|90.0|-1.89|0.01||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.01|-1.89|0.1038
71066892|NCT01164579|141642434|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.01|STANDARD_ERROR_OF_MEAN|0.59||0.0868|TWO_SIDED|90.0|-1.98|-0.04||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.04|-1.98|0.0868
71066893|NCT01164579|141642434|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.6|STANDARD_ERROR_OF_MEAN|0.62||0.0103|TWO_SIDED|90.0|-2.62|-0.58||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.58|-2.62|0.0103
71066894|NCT01164579|141642434|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.49|STANDARD_ERROR_OF_MEAN|0.63||0.435|TWO_SIDED|90.0|-1.53|0.55||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.55|-1.53|0.4350
71066895|NCT01164579|141642435|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4|STANDARD_ERROR_OF_MEAN|0.58||0.489|TWO_SIDED|90.0|-1.36|0.56||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||0.56|-1.36|0.4890
71066896|NCT01164579|141642435|SUPERIORITY_OR_OTHER||Difference in LS Means|0.08|STANDARD_ERROR_OF_MEAN|0.57||0.8817|TWO_SIDED|90.0|-0.85|1.02||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||1.02|-0.85|0.8817
71066897|NCT01164579|141642435|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.24|STANDARD_ERROR_OF_MEAN|0.59||0.0351|TWO_SIDED|90.0|-2.21|-0.27||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||-0.27|-2.21|0.0351
71066898|NCT01164579|141642435|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.32|STANDARD_ERROR_OF_MEAN|0.58||0.0231|TWO_SIDED|90.0|-2.28|-0.37||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||-0.37|-2.28|0.0231
71066899|NCT01164579|141642435|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.1|STANDARD_ERROR_OF_MEAN|0.62||0.0008|TWO_SIDED|90.0|-3.13|-1.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-1.08|-3.13|0.0008
71066900|NCT01164579|141642435|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.29|STANDARD_ERROR_OF_MEAN|0.63||0.0003|TWO_SIDED|90.0|-3.32|-1.25||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-1.25|-3.32|0.0003
71066901|NCT01164579|141642436|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.35||0.2689|TWO_SIDED|90.0|-0.96|0.19||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||0.19|-0.96|0.2689
71066902|NCT01164579|141642436|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0|STANDARD_ERROR_OF_MEAN|0.35||0.9935|TWO_SIDED|90.0|-0.58|0.57||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||0.57|-0.58|0.9935
71066903|NCT01164579|141642436|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.57|STANDARD_ERROR_OF_MEAN|0.35||0.1086|TWO_SIDED|90.0|-1.15|0.01||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||0.01|-1.15|0.1086
71066904|NCT01164579|141642436|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.08|STANDARD_ERROR_OF_MEAN|0.35||0.8092|TWO_SIDED|90.0|-0.66|0.49||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||0.49|-0.66|0.8092
71066905|NCT01164579|141642436|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.35||0.0463|TWO_SIDED|90.0|-1.29|-0.12||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.12|-1.29|0.0463
71066906|NCT01164579|141642436|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.35||0.0624|TWO_SIDED|90.0|-1.25|-0.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.08|-1.25|0.0624
71066907|NCT01164579|141642436|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.29|STANDARD_ERROR_OF_MEAN|0.37||0.0005|TWO_SIDED|90.0|-1.9|-0.69||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.69|-1.90|0.0005
71066908|NCT01164579|141642436|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.26|STANDARD_ERROR_OF_MEAN|0.37||0.0008|TWO_SIDED|90.0|-1.87|-0.65||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.65|-1.87|0.0008
71066909|NCT01164579|141642437|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.72||0.5019|TWO_SIDED|90.0|-1.68|0.71||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.71|-1.68|0.5019
71066910|NCT01164579|141642437|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.07|STANDARD_ERROR_OF_MEAN|0.73||0.1462|TWO_SIDED|90.0|-2.28|0.14||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.14|-2.28|0.1462
71066911|NCT01164579|141642437|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.74||0.49|TWO_SIDED|90.0|-1.74|0.72||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.72|-1.74|0.4900
71066912|NCT01164579|141642437|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.51|STANDARD_ERROR_OF_MEAN|0.75||0.0459|TWO_SIDED|90.0|-2.76|-0.27|||mixed model repeated measures analysis|||Month 12||-0.27|-2.76|0.0459
71066913|NCT01164579|141642438|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.72||0.5019|TWO_SIDED|90.0|-1.68|0.71||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.71|-1.68|0.5019
71066914|NCT01164579|141642438|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.07|STANDARD_ERROR_OF_MEAN|0.73||0.1462|TWO_SIDED|90.0|-2.28|0.14||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.14|-2.28|0.1462
71066915|NCT01164579|141642438|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.74||0.49|TWO_SIDED|90.0|-1.74|0.72||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.72|-1.74|0.4900
71066916|NCT01164579|141642438|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.51|STANDARD_ERROR_OF_MEAN|0.75||0.0459|TWO_SIDED|90.0|-2.76|-0.27||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.27|-2.76|0.0459
71066917|NCT01164579|141642439|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.07|STANDARD_ERROR_OF_MEAN|0.5||0.8959|TWO_SIDED|90.0|-0.89|0.76||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.76|-0.89|0.8959
71066918|NCT01164579|141642439|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.41|STANDARD_ERROR_OF_MEAN|0.5||0.4193|TWO_SIDED|90.0|-1.25|0.43||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.43|-1.25|0.4193
70938506|NCT01922102|141377326|NON_INFERIORITY_OR_EQUIVALENCE|"one-sided hypotheses were tested under the Type I error rate of 0.025, if H01 and H02 were rejected: H03: μRanibizumab-II - μRanibizumab-I ≤ -5 vs. HA3: μRanibizumab-II - μRanibizumab-I \> -5.~Otherwise, H03 was not to be considered as rejected."|Mean Difference (Net)|0.4|||<|0.001|TWO_SIDED|95.0|-1.3|2.1||Non-inferiority could be claimed if the corresponding one-sided p-value was ≤ 0.025.|Cochran-Mantel-Haenszel||Differences in LS means and the two-sided 95% CIs are estimated from pairwise ANOVA (stratified) model.|||2.1|-1.3|<0.001
70938507|NCT01077284|141377360|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.001
70938508|NCT01077284|141377360|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)|||||||0.003
70938509|NCT01077284|141377361|SUPERIORITY_OR_OTHER|||||||0.13||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)|||||||0.130
70938510|NCT01077284|141377361|SUPERIORITY_OR_OTHER|||||||0.348||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)|||||||0.348
70938511|NCT01077284|141377362|SUPERIORITY_OR_OTHER|||||||0.403||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)|||||||0.403
70938512|NCT01077284|141377362|SUPERIORITY_OR_OTHER|||||||0.413||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)|||||||0.413
70938513|NCT01077284|141377363|SUPERIORITY_OR_OTHER|||||||0.5535||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|ANOVA|P-values are from ANOVA with treatment as a fixed effect.||||||0.5535
70938514|NCT01077284|141377363|SUPERIORITY_OR_OTHER|||||||0.94||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|ANOVA|P-values are from ANOVA with treatment as a fixed effect.||||||0.9400
70938515|NCT01180400|141377367|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.91||0.944|TWO_SIDED|95.0|-1.86|1.73||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.73|-1.86|0.944
71066919|NCT01164579|141642439|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.29|STANDARD_ERROR_OF_MEAN|0.51||0.5764|TWO_SIDED|90.0|-1.13|0.56||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.56|-1.13|0.5764
70938516|NCT01180400|141377368|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01|STANDARD_ERROR_OF_MEAN|0.26||0.974|TWO_SIDED|95.0|0.61|1.66|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.66|0.61|0.974
70938517|NCT01180400|141377369|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45|STANDARD_ERROR_OF_MEAN|0.41||0.184|TWO_SIDED|95.0|0.84|2.53|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.53|0.84|0.184
71028410|NCT00721409|141564204|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.37||||0.0849|TWO_SIDED|95.0|0.74|7.84||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.||7.84|0.74|0.0849
71028411|NCT00721409|141564204|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.14||||0.4515|TWO_SIDED|95.0|0.48|2.76||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.||2.76|0.48|0.4515
71066920|NCT01164579|141642439|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.83|STANDARD_ERROR_OF_MEAN|0.52||0.1101|TWO_SIDED|90.0|-1.69|0.02||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.02|-1.69|0.1101
71066921|NCT01164579|141642440|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.07|STANDARD_ERROR_OF_MEAN|0.5||0.8959|TWO_SIDED|90.0|-0.89|0.76||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.76|-0.89|0.8959
71066922|NCT01164579|141642440|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.41|STANDARD_ERROR_OF_MEAN|0.5||0.4193|TWO_SIDED|90.0|-1.25|0.43||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.43|-1.25|0.4193
71066923|NCT01164579|141642440|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.29|STANDARD_ERROR_OF_MEAN|0.51||0.5764|TWO_SIDED|90.0|-1.13|0.56||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.56|-1.13|0.5764
71066924|NCT01164579|141642440|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.83|STANDARD_ERROR_OF_MEAN|0.52||0.1101|TWO_SIDED|90.0|-1.69|0.02||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.02|-1.69|0.1101
71066925|NCT01164579|141642441|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.42|STANDARD_ERROR_OF_MEAN|0.35||0.2351|TWO_SIDED|90.0|-1.0|0.16||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.16|-1.00|0.2351
71066926|NCT01164579|141642441|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.36||0.0631|TWO_SIDED|90.0|-1.27|-0.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.08|-1.27|0.0631
70938518|NCT01180400|141377370|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44|STANDARD_ERROR_OF_MEAN|0.71||0.461|TWO_SIDED|95.0|0.55|3.78|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||3.78|0.55|0.461
70938519|NCT01180400|141377371|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87|STANDARD_ERROR_OF_MEAN|0.31||0.689|TWO_SIDED|95.0|0.43|1.75|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.75|0.43|0.689
70938520|NCT01180400|141377372|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.44||0.831|TWO_SIDED|95.0|0.35|2.32|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.32|0.35|0.831
70938521|NCT01180400|141377373|SUPERIORITY_OR_OTHER||LS mean|0.5|STANDARD_ERROR_OF_MEAN|0.72||0.525|TWO_SIDED|95.0|-0.96|1.89|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.89|-0.96|0.525
70938522|NCT01180400|141377374|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.964||95.0|-0.28|0.26|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.26|-0.28|0.964
70938523|NCT01180400|141377375|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93|STANDARD_ERROR_OF_MEAN|0.25||0.783|TWO_SIDED|95.0|0.54|1.58|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||1.58|0.54|0.783
71066927|NCT01164579|141642441|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.23|STANDARD_ERROR_OF_MEAN|0.36||0.5369|TWO_SIDED|90.0|-0.83|0.38||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.38|-0.83|0.5369
71066928|NCT01164579|141642441|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.69|STANDARD_ERROR_OF_MEAN|0.37||0.062|TWO_SIDED|90.0|-1.31|-0.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.08|-1.31|0.0620
71066929|NCT01164579|141642442|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.42|STANDARD_ERROR_OF_MEAN|0.35||0.2351|TWO_SIDED|90.0|-1.0|0.16||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.16|-1.00|0.2351
71066930|NCT01164579|141642442|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.36||0.0631|TWO_SIDED|90.0|-1.27|-0.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.08|-1.27|0.0631
71112033|NCT01763333|141730830|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|74.44|||||TWO_SIDED|90.0|66.322|83.562|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2) : Sol. fasted (R2) for AUC0-inf.The per protocol set for the evaluation of relative bioavailability of T2 vs R2 (PPS-BA-T2-R2) was used.||83.562|66.322|
70938524|NCT01180400|141377376|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.51||0.832|TWO_SIDED|95.0|-0.89|1.11||Analysis for change in MADRS total score from randomization to Week 9.|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.11|-0.89|0.832
70938525|NCT01180400|141377377|SUPERIORITY_OR_OTHER||LS mean|0.5|STANDARD_ERROR_OF_MEAN|0.67||0.468|TWO_SIDED|95.0|-0.84|1.82|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.82|-0.84|0.468
71066931|NCT01164579|141642442|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.23|STANDARD_ERROR_OF_MEAN|0.36||0.5369|TWO_SIDED|90.0|-0.83|0.38||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.38|-0.83|0.5369
71066932|NCT01164579|141642442|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.69|STANDARD_ERROR_OF_MEAN|0.37||0.062|TWO_SIDED|90.0|-1.31|-0.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.08|-1.31|0.0620
71066933|NCT01164579|141642443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.12|STANDARD_ERROR_OF_MEAN|11.24||0.243|TWO_SIDED|90.0|-5.36|31.62|||Normal approximation to the binomial|||Month 1||31.62|-5.36|0.2430
71066934|NCT01164579|141642443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.41|STANDARD_ERROR_OF_MEAN|11.24||0.0147|TWO_SIDED|90.0|8.91|45.9|||Normal approximation to the binomial|||Month 1||45.90|8.91|0.0147
71066935|NCT01164579|141642443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.03|STANDARD_ERROR_OF_MEAN|11.25||0.0127|TWO_SIDED|90.0|9.51|46.54|||Normal approximation to the binomial|||Month 2||46.54|9.51|0.0127
71066936|NCT01164579|141642443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.57|STANDARD_ERROR_OF_MEAN|11.45||0.0724|TWO_SIDED|90.0|1.73|39.41|||Normal approximation to the binomial|||Month 2||39.41|1.73|0.0724
71066937|NCT01164579|141642443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.49|STANDARD_ERROR_OF_MEAN|10.85||0.0086|TWO_SIDED|90.0|10.63|46.35|||Normal approximation to the binomial|||Month 3||46.35|10.63|0.0086
71066938|NCT01164579|141642443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.46|STANDARD_ERROR_OF_MEAN|11.55||0.2808|TWO_SIDED|90.0|-6.54|31.47|||Normal approximation to the binomial|||Month 3||31.47|-6.54|0.2808
71066939|NCT01164579|141642443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.18|STANDARD_ERROR_OF_MEAN|11.16||0.0115|TWO_SIDED|90.0|9.81|46.55|||Normal approximation to the binomial|||Month 9||46.55|9.81|0.0115
70938526|NCT01180400|141377378|SUPERIORITY_OR_OTHER||LS mean|1.0|STANDARD_ERROR_OF_MEAN|0.77||0.187|TWO_SIDED|95.0|-0.49|2.52|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.52|-0.49|0.187
70938527|NCT01180400|141377379|SUPERIORITY_OR_OTHER||LS mean|1.3|STANDARD_ERROR_OF_MEAN|0.86||0.145|TWO_SIDED|95.0|-0.44|2.95|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects the model; pooled center is a random effect.||2.95|-0.44|0.145
70938528|NCT01180400|141377380|SUPERIORITY_OR_OTHER||LS mean|-0.04|STANDARD_ERROR_OF_MEAN|0.766||0.956|TWO_SIDED|95.0|-1.549|1.466||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.466|-1.549|0.956
70938529|NCT01180400|141377381|SUPERIORITY_OR_OTHER||LS mean|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.201|TWO_SIDED|95.0|-0.98|0.21||Analysis for change in SDS work/school domain score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.21|-0.98|0.201
71066940|NCT01164579|141642443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.09|STANDARD_ERROR_OF_MEAN|11.56||0.1921|TWO_SIDED|90.0|-3.94|34.12|||Normal approximation to the binomial|||Month 9||34.12|-3.94|0.1921
71066941|NCT01164579|141642443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.18|STANDARD_ERROR_OF_MEAN|11.16||0.0115|TWO_SIDED|90.0|9.81|46.55|||Normal approximation to the binomial|||Month 12||46.55|9.81|0.0115
71066942|NCT01164579|141642443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.86|STANDARD_ERROR_OF_MEAN|11.5||0.1203|TWO_SIDED|90.0|-1.05|36.79|||Normal approximation to the binomial|||Month 12||36.79|-1.05|0.1203
71066943|NCT01164579|141642444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.15|STANDARD_ERROR_OF_MEAN|7.58||0.0078|TWO_SIDED|90.0|7.68|32.62|||Normal approximation to the binomial|||Month 1||32.62|7.68|0.0078
71066944|NCT01164579|141642444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.15|STANDARD_ERROR_OF_MEAN|7.58||0.0078|TWO_SIDED|90.0|7.68|32.62|||Normal approximation to the binomial|||Month 1||32.62|7.68|0.0078
71066945|NCT01164579|141642444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.49|STANDARD_ERROR_OF_MEAN|10.37||0.0044|TWO_SIDED|90.0|12.43|46.56|||Normal approximation to the binomial|||Month 2||46.56|12.43|0.0044
71066946|NCT01164579|141642444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.11|STANDARD_ERROR_OF_MEAN|9.92||0.0845|TWO_SIDED|90.0|0.79|33.43|||Normal approximation to the binomial|||Month 2||33.43|0.79|0.0845
71066947|NCT01164579|141642444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.24|STANDARD_ERROR_OF_MEAN|11.0||0.0275|TWO_SIDED|90.0|6.14|42.35|||Normal approximation to the binomial|||Month 3||42.35|6.14|0.0275
71066948|NCT01164579|141642444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.67|STANDARD_ERROR_OF_MEAN|10.91||0.0186|TWO_SIDED|90.0|7.71|43.63|||Normal approximation to the binomial|||Month 3||43.63|7.71|0.0186
71066949|NCT01164579|141642444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.52|STANDARD_ERROR_OF_MEAN|10.75||0.0009|TWO_SIDED|90.0|17.82|53.22|||Normal approximation to the binomial|||Month 6||53.22|17.82|0.0009
71066950|NCT01164579|141642444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.6|STANDARD_ERROR_OF_MEAN|10.72||0.0169|TWO_SIDED|90.0|7.95|43.24|||Normal approximation to the binomial|||Month 6||43.24|7.95|0.0169
71066951|NCT01164579|141642444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.41|STANDARD_ERROR_OF_MEAN|11.24||0.0147|TWO_SIDED|90.0|8.91|45.9|||Normal approximation to the binomial|||Month 9||45.90|8.91|0.0147
71066952|NCT01164579|141642444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.71|STANDARD_ERROR_OF_MEAN|11.18||0.1882|TWO_SIDED|90.0|-3.68|33.11|||Normal approximation to the binomial|||Month 9||33.11|-3.68|0.1882
71066953|NCT01164579|141642444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.41|STANDARD_ERROR_OF_MEAN|11.24||0.0147|TWO_SIDED|90.0|8.91|45.9|||Normal approximation to the binomial|||Month 12||45.90|8.91|0.0147
71066954|NCT01164579|141642444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.71|STANDARD_ERROR_OF_MEAN|11.18||0.1882|TWO_SIDED|90.0|-3.68|33.11|||Normal approximation to the binomial|||Month 12||33.11|-3.68|0.1882
71066955|NCT01164579|141642445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.57|STANDARD_ERROR_OF_MEAN|4.73||0.07|TWO_SIDED|90.0|0.78|16.35|||Normal approximation to the binomial|||Month 1||16.35|0.78|0.0700
71066956|NCT01164579|141642445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.85|STANDARD_ERROR_OF_MEAN|2.81||0.3102|TWO_SIDED|90.0|-1.77|7.48|||Normal approximation to the binomial|||Month 1||7.48|-1.77|0.3102
71066957|NCT01164579|141642445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.02|STANDARD_ERROR_OF_MEAN|8.68||0.0027|TWO_SIDED|90.0|11.73|40.3|||Normal approximation to the binomial|||Month 2||40.30|11.73|0.0027
71066958|NCT01164579|141642445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.81|STANDARD_ERROR_OF_MEAN|7.86||0.0324|TWO_SIDED|90.0|3.88|29.75|||Normal approximation to the binomial|||Month 2||29.75|3.88|0.0324
71066959|NCT01164579|141642445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.9|STANDARD_ERROR_OF_MEAN|8.97||0.0969|TWO_SIDED|90.0|0.13|29.67|||Normal approximation to the binomial|||Month 3||29.67|0.13|0.0969
71066960|NCT01164579|141642445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.96|STANDARD_ERROR_OF_MEAN|9.04||0.0606|TWO_SIDED|90.0|2.09|31.84|||Normal approximation to the binomial|||Month 3||31.84|2.09|0.0606
70938530|NCT01180400|141377382|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.27||0.756|TWO_SIDED|95.0|-0.62|0.45|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.45|-0.62|0.756
70938531|NCT01180400|141377383|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.27||0.62|TWO_SIDED|95.0|-0.4|0.68|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.68|-0.40|0.620
71066961|NCT01164579|141642445|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.66|STANDARD_ERROR_OF_MEAN|10.49||0.2276|TWO_SIDED|90.0|-4.6|29.93|||Normal approximation to the binomial|||Month 6||29.93|-4.60|0.2276
71066962|NCT01164579|141642445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.93|STANDARD_ERROR_OF_MEAN|10.23||0.3827|TWO_SIDED|90.0|-7.9|25.76|||Normal approximation to the binomial|||Month 6||25.76|-7.90|0.3827
71112034|NCT01763333|141730830|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|137.25|||||TWO_SIDED|90.0|119.708|157.353|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fasted (R2): Tab. fasted (R1) for AUC0-inf.The per protocol set for the evaluation of relative bioavailability of R2 vs R1 (PPS-BA-R2-R1) was used.||157.353|119.708|
71066963|NCT01164579|141642445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.5|STANDARD_ERROR_OF_MEAN|10.15||0.2177|TWO_SIDED|90.0|-4.18|29.2|||Normal approximation to the binomial|||Month 9||29.20|-4.18|0.2177
71066964|NCT01164579|141642445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.41|STANDARD_ERROR_OF_MEAN|10.15||0.1558|TWO_SIDED|90.0|-2.29|31.12|||Normal approximation to the binomial|||Month 9||31.12|-2.29|0.1558
71066965|NCT01164579|141642445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.23|STANDARD_ERROR_OF_MEAN|9.8||0.8997|TWO_SIDED|90.0|-14.89|17.36|||Normal approximation to the binomial|||Month 12||17.36|-14.89|0.8997
71112035|NCT01763333|141730830|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|116.48|||||TWO_SIDED|90.0|111.462|121.724|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2): Tab. fed (T1) for AUC0-inf.The per protocol set for the evaluation of relative bioavailability of T2 vs T1 (PPS-BA-T2-T1) was used.||121.724|111.462|
70938532|NCT01180400|141377384|SUPERIORITY_OR_OTHER||LS mean|0.15|STANDARD_ERROR_OF_MEAN|1.592||0.924|TWO_SIDED|95.0|-2.981|3.286|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||3.286|-2.981|0.924
71066966|NCT01164579|141642445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.71|STANDARD_ERROR_OF_MEAN|10.36||0.2587|TWO_SIDED|90.0|-5.34|28.76|||Normal approximation to the binomial|||Month 12||28.76|-5.34|0.2587
71066967|NCT01164579|141642446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|||||TWO_SIDED|90.0|-0.56|0.13||||||Baseline||0.13|-0.56|
71066968|NCT01164579|141642446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|||||TWO_SIDED|90.0|-0.19|0.43||||||Baseline||0.43|-0.19|
71066969|NCT01164579|141642446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|||||TWO_SIDED|90.0|-1.38|-0.5||||||Month 1||-0.50|-1.38|
71066970|NCT01164579|141642446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|||||TWO_SIDED|90.0|-1.01|-0.22||||||Month 1||-0.22|-1.01|
71066971|NCT01164579|141642446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21|||||TWO_SIDED|90.0|-1.73|-0.7||||||Month 2||-0.70|-1.73|
71066972|NCT01164579|141642446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|||||TWO_SIDED|90.0|-1.2|-0.18||||||Month 2||-0.18|-1.20|
71066973|NCT01164579|141642446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81|||||TWO_SIDED|90.0|-1.33|-0.29||||||Month 3||-0.29|-1.33|
71066974|NCT01164579|141642446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|||||TWO_SIDED|90.0|-0.94|0.12||||||Month 3||0.12|-0.94|
71066975|NCT01164579|141642446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18|||||TWO_SIDED|90.0|-1.75|-0.61||||||Month 6||-0.61|-1.75|
71066976|NCT01164579|141642446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18|||||TWO_SIDED|90.0|-1.73|-0.63||||||Month 6||-0.63|-1.73|
71066977|NCT01164579|141642446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21|||||TWO_SIDED|90.0|-1.81|-0.61||||||Month 9||-0.61|-1.81|
71066978|NCT01164579|141642446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|||||TWO_SIDED|90.0|-1.33|-0.13||||||Month 9||-0.13|-1.33|
71066979|NCT01164579|141642446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|90.0|-1.69|-0.51||||||Month 12||-0.51|-1.69|
71066980|NCT01164579|141642446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|90.0|-1.51|-0.29||||||Month 12||-0.29|-1.51|
71112036|NCT01763333|141730831|SUPERIORITY_OR_OTHER||Slope|0.8428|||||TWO_SIDED|95.0|0.658|1.0275|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose). Dose proportionality of tablets for AUC 0- tz was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.||1.0275|0.6580|
71112037|NCT01763333|141730831|SUPERIORITY_OR_OTHER||Slope|0.9307|||||TWO_SIDED|95.0|0.8187|1.0426|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1.|This was non confirmatory testing (Single dose). Dose proportionality of solution for AUC0-tz was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.||1.0426|0.8187|
70852724|NCT01578850|141194338|SUPERIORITY_OR_OTHER||Difference in proportions|-0.2||||0.742|TWO_SIDED|95.0|-4.21|3.9|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 20: Week 24||3.90|-4.21|0.742
71066981|NCT01164579|141642447|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.88|STANDARD_ERROR_OF_MEAN|0.26||0.001|TWO_SIDED|90.0|-1.31|-0.45||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||-0.45|-1.31|0.0010
71066982|NCT01164579|141642447|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.26||0.0102|TWO_SIDED|90.0|-1.1|-0.24||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||-0.24|-1.10|0.0102
71066983|NCT01164579|141642447|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.08|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|90.0|-1.52|-0.64||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 2||-0.64|-1.52|<0.0001
71066984|NCT01164579|141642447|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.27||0.0175|TWO_SIDED|90.0|-1.08|-0.2||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 2||-0.20|-1.08|0.0175
71066985|NCT01164579|141642447|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.68|STANDARD_ERROR_OF_MEAN|0.27||0.0125|TWO_SIDED|90.0|-1.13|-0.23||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||-0.23|-1.13|0.0125
71066986|NCT01164579|141642447|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.27||0.1457|TWO_SIDED|90.0|-0.84|0.05||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||0.05|-0.84|0.1457
71066987|NCT01164579|141642447|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.02|STANDARD_ERROR_OF_MEAN|0.28||0.0003|TWO_SIDED|90.0|-1.48|-0.57||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.57|-1.48|0.0003
71066988|NCT01164579|141642447|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.03|STANDARD_ERROR_OF_MEAN|0.28||0.0002|TWO_SIDED|90.0|-1.49|-0.58||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.58|-1.49|0.0002
71066989|NCT01164579|141642447|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.16|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|90.0|-1.63|-0.69||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 9||-0.69|-1.63|<0.0001
71066990|NCT01164579|141642447|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.28||0.0196|TWO_SIDED|90.0|-1.14|-0.2||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 9||-0.20|-1.14|0.0196
71066991|NCT01164579|141642447|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.01|STANDARD_ERROR_OF_MEAN|0.3||0.0007|TWO_SIDED|90.0|-1.5|-0.52||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.52|-1.50|0.0007
71066992|NCT01164579|141642447|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.84|STANDARD_ERROR_OF_MEAN|0.3||0.0049|TWO_SIDED|90.0|-1.32|-0.35||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.35|-1.32|0.0049
71066993|NCT01164579|141642448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|90.0|-0.53|0.15||||||Baseline||0.15|-0.53|
71066994|NCT01164579|141642448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|||||TWO_SIDED|90.0|-0.24|0.36||||||Baseline||0.36|-0.24|
71066995|NCT01164579|141642448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91|||||TWO_SIDED|90.0|-1.4|-0.42||||||Month 1||-0.42|-1.40|
71066996|NCT01164579|141642448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|||||TWO_SIDED|90.0|-1.01|-0.14||||||Month 1||-0.14|-1.01|
71066997|NCT01164579|141642448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28|||||TWO_SIDED|90.0|-1.82|-0.73||||||Month 2||-0.73|-1.82|
71066998|NCT01164579|141642448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|||||TWO_SIDED|90.0|-1.25|-0.13||||||Month 2||-0.13|-1.25|
71066999|NCT01164579|141642448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|||||TWO_SIDED|90.0|-1.55|-0.38||||||Month 3||-0.38|-1.55|
71067000|NCT01164579|141642448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|||||TWO_SIDED|90.0|-1.12|0.11||||||Month 3||0.11|-1.12|
71067001|NCT01164579|141642448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.43|||||TWO_SIDED|90.0|-2.13|-0.72||||||Month 6||-0.72|-2.13|
71067002|NCT01164579|141642448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24|||||TWO_SIDED|90.0|-1.91|-0.57||||||Month 6||-0.57|-1.91|
71067003|NCT01164579|141642448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11|||||TWO_SIDED|90.0|-1.84|-0.39||||||Month 9||-0.39|-1.84|
71067004|NCT01164579|141642448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||||TWO_SIDED|90.0|-1.3|0.13||||||Month 9||0.13|-1.30|
71067005|NCT01164579|141642448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11|||||TWO_SIDED|90.0|-1.84|-0.39||||||Month 12||-0.39|-1.84|
71067006|NCT01164579|141642448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|90.0|-1.43|0.11||||||Month 12||0.11|-1.43|
70852725|NCT01578850|141194338|SUPERIORITY_OR_OTHER||Difference in proportions|9.8||||0.143|TWO_SIDED|95.0|2.45|17.06|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 20: Week 28||17.06|2.45|0.143
70938533|NCT01180400|141377385|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.345|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.10|-0.30|0.345
70938534|NCT01180400|141377386|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.942|TWO_SIDED|95.0|-0.2|0.19|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.19|-0.20|0.942
70938535|NCT01180400|141377387|SUPERIORITY_OR_OTHER||LS mean|-0.011|STANDARD_ERROR_OF_MEAN|0.0198||0.576|TWO_SIDED|95.0|-0.05|0.0279||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0279|-0.0500|0.576
70938536|NCT01180400|141377387|SUPERIORITY_OR_OTHER||LS mean|-0.4|STANDARD_ERROR_OF_MEAN|2.11||0.842|TWO_SIDED|95.0|-4.58|3.73||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||3.73|-4.58|0.842
70938537|NCT00248794|141377404|SUPERIORITY_OR_OTHER||||||<|0.97|||||||ANOVA|||||||<.97
70938538|NCT00248794|141377405|SUPERIORITY_OR_OTHER|||||||0.77|||||||ANOVA|||||||.77
70938539|NCT03449979|141377409|SUPERIORITY|||||||0.0852|||||||ANOVA|degrees of freedom = (1,39); F-statistic = 3.119||Interaction in the effect of tACS on left frontal alpha oscillation in the depressed group. Two-way interaction of within-participant factor of before/after tACS and between-participant factor of alpha-tACS/placebo.||||0.0852
70938540|NCT03449979|141377409|SUPERIORITY|||||||0.6676|||||||ANOVA|degrees of freedom = (1,39); F-statistic = 0.187||Interaction in the effect of tACS on left frontal alpha oscillation in the healthy group. Two-way interaction of within-participant factor of before/after tACS and between-participant factor of alpha-tACS/placebo.||||0.6676
70938541|NCT03449979|141377409|SUPERIORITY|||||||0.929||||||degrees of freedom = (1,41); F-statistic = 0.008|ANOVA|||Main effect of alpha-tACS on session (before and after) on left frontal alpha oscillations across both groups (healthy and patient).||||0.929
70938542|NCT03449979|141377409|SUPERIORITY|||||||0.195|||||||t-test, 1 sided|degrees of freedom = 20; t-statistic = -0.08789||Difference in alpha oscillations after versus before in the depressed cohort (one-tailed Student's t-test) with the hypothesis to decrease pathologically elevate left frontal alpha oscillations||||0.1950
70938543|NCT03449979|141377409|SUPERIORITY|||||||0.8603|||||||t-test, 1 sided|degrees of freedom = 20; t-statistic = 1.1117||Difference in alpha oscillations after versus before in the healthy cohort (one-tailed Student's t-test) run as a control analysis||||0.8603
70938544|NCT00700999|141377426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92|STANDARD_DEVIATION|0.9||0.001|TWO_SIDED|95.0|-1.38|-0.45|||t-test, 2 sided|||||-0.45|-1.38|.001
70938545|NCT00700999|141377426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_DEVIATION|1.78||0.869|TWO_SIDED|95.0|-0.84|0.99|||t-test, 2 sided|||||.99|-.84|.869
71067007|NCT01164579|141642449|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.84|STANDARD_ERROR_OF_MEAN|0.29||0.0046|TWO_SIDED|90.0|-1.32|-0.35||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||-0.35|-1.32|0.0046
70938546|NCT02432183|141377451|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0061|||||||Kruskal-Wallis|post-hoc comparison with Dunn's multiple comparison test: p=0.0326 between arm 1 and 2; p=0.0147 between arm 1 and 3||||||0.0061
71067008|NCT01164579|141642449|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.63|STANDARD_ERROR_OF_MEAN|0.29||0.0303|TWO_SIDED|90.0|-1.11|-0.15||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||-0.15|-1.11|0.0303
70938547|NCT01133678|141377473|OTHER|||||||0.19||||||A recommendation to stop the trial early was stipulated if the conditional power at the interim analysis (after 50 patients) was \<10% using a stochastic curtailment approach.. This would occur if the interim test statistic is t \< -0.287.|t-test, 2 sided|t-statistic = -1.330, exceeding threshold (\<-0.287, conditional power\<10%) for early termination.||||||0.190
70938548|NCT00424476|141377490|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.0006||95.0|1.3|2.59||For the primary analysis of the primary efficacy endpoint, a step-down sequential testing procedure was used to control the type 1 error.|Regression, Logistic|Adjusted for baseline stratification factors (SELENA SLEDAI Score: ≤9 vs ≥10; proteinuria: \<2g vs ≥2g per 24hr; Race: African/indig-American vs Other)||||2.59|1.30|0.0006
70938549|NCT00424476|141377490|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.0129|TWO_SIDED|95.0|1.1|2.19||After superiority of 10 mg/kg vs placebo was established, the 1 mg/kg group was tested vs placebo (2-sided alpha=0.05).|Regression, Logistic|Adjusted for baseline stratification factors.||||2.19|1.10|0.0129
70938550|NCT00424476|141377491|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.0024|TWO_SIDED|95.0|1.21|2.41|||Regression, Logistic|Adjusted for baseline stratification factors.||||2.41|1.21|0.0024
70938551|NCT00424476|141377491|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.0189|TWO_SIDED|95.0|1.07|2.14|||Regression, Logistic|Adjusted for baseline stratification factors.||||2.14|1.07|0.0189
70938552|NCT00424476|141377492|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||ANCOVA|Adjusted for baseline PGA score and baseline stratification factors.||||||0.0003
70938553|NCT00424476|141377492|SUPERIORITY_OR_OTHER|||||||0.2712||95.0|||||ANCOVA|Adjusted for baseline PGA score and baseline stratification factors.||||||0.2712
70938554|NCT00424476|141377493|SUPERIORITY_OR_OTHER|||||||0.887|||||||ANCOVA|Adjusted for the baseline PCS score and baseline stratification factors.||||||0.8870
70938555|NCT00424476|141377493|SUPERIORITY_OR_OTHER|||||||0.8127|||||||ANCOVA|Adjusted for the baseline PCS score and baseline stratification factors.||||||0.8127
70938556|NCT00424476|141377494|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.0526|TWO_SIDED|95.0|0.99|3.08|||Regression, Logistic|Adjusted for baseline prednisone dose level and baseline stratification factors.||||3.08|0.99|0.0526
70938557|NCT00424476|141377494|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.89||||0.0252|TWO_SIDED|95.0|1.08|3.31|||Regression, Logistic|Adjusted for baseline prednisone dose level and baseline stratification factors.||||3.31|1.08|0.0252
70938558|NCT01280656|141377510|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Chi-squared|||||||0.003
71067009|NCT01164579|141642449|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.18|STANDARD_ERROR_OF_MEAN|0.3||0.0001|TWO_SIDED|90.0|-1.69|-0.68||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 2||-0.68|-1.69|0.0001
71067010|NCT01164579|141642449|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.3||0.0255|TWO_SIDED|90.0|-1.17|-0.18||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 2||-0.18|-1.17|0.0255
71067011|NCT01164579|141642449|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.89|STANDARD_ERROR_OF_MEAN|0.3||0.0035|TWO_SIDED|90.0|-1.39|-0.39||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||-0.39|-1.39|0.0035
70938559|NCT01280656|141377511|SUPERIORITY_OR_OTHER|||||||0.693|||||||Chi-squared|||||||0.693
71067012|NCT01164579|141642449|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.55|STANDARD_ERROR_OF_MEAN|0.3||0.0683|TWO_SIDED|90.0|-1.05|-0.05||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||-0.05|-1.05|0.0683
71067013|NCT01164579|141642449|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.29|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|90.0|-1.81|-0.78||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.78|-1.81|<0.0001
71067014|NCT01164579|141642449|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.08|STANDARD_ERROR_OF_MEAN|0.31||0.0006|TWO_SIDED|90.0|-1.59|-0.56||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.56|-1.59|0.0006
71067015|NCT01164579|141642449|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.15|STANDARD_ERROR_OF_MEAN|0.32||0.0004|TWO_SIDED|90.0|-1.67|-0.62||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 9||-0.62|-1.67|0.0004
71067016|NCT01164579|141642449|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.58|STANDARD_ERROR_OF_MEAN|0.32||0.0706|TWO_SIDED|90.0|-1.1|-0.05||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 9||-0.05|-1.10|0.0706
71067017|NCT01164579|141642449|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.13|STANDARD_ERROR_OF_MEAN|0.33||0.0008|TWO_SIDED|90.0|-1.67|-0.58||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.58|-1.67|0.0008
71067018|NCT01164579|141642449|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.66|STANDARD_ERROR_OF_MEAN|0.33||0.0466|TWO_SIDED|90.0|-1.21|-0.12||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.12|-1.21|0.0466
71067019|NCT01164579|141642450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.51|STANDARD_ERROR_OF_MEAN|11.04||0.0032|TWO_SIDED|90.0|14.34|50.68||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||50.68|14.34|0.0032
71067020|NCT01164579|141642450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.18|STANDARD_ERROR_OF_MEAN|11.16||0.0115|TWO_SIDED|90.0|9.81|46.55||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||46.55|9.81|0.0115
71067021|NCT01164579|141642450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.41|STANDARD_ERROR_OF_MEAN|9.48||0.0002|TWO_SIDED|90.0|18.81|50.02||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||50.02|18.81|0.0002
71067022|NCT01164579|141642450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.79|STANDARD_ERROR_OF_MEAN|10.48||0.0231|TWO_SIDED|90.0|6.55|41.03||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||41.03|6.55|0.0231
71067023|NCT01164579|141642450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.41|STANDARD_ERROR_OF_MEAN|9.48||0.0002|TWO_SIDED|90.0|18.81|50.02||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||50.02|18.81|0.0002
71067024|NCT01164579|141642450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.02|STANDARD_ERROR_OF_MEAN|10.69||0.0493|TWO_SIDED|90.0|3.43|38.61||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||38.61|3.43|0.0493
71067025|NCT01164579|141642450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.18|STANDARD_ERROR_OF_MEAN|9.88||0.0005|TWO_SIDED|90.0|17.92|50.43||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||50.43|17.92|0.0005
71067026|NCT01164579|141642450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.72|STANDARD_ERROR_OF_MEAN|10.73||0.027|TWO_SIDED|90.0|6.07|41.37||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||41.37|6.07|0.0270
71067027|NCT01164579|141642450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.46|STANDARD_ERROR_OF_MEAN|10.73||0.0018|TWO_SIDED|90.0|15.8|51.12||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||51.12|15.80|0.0018
71067028|NCT01164579|141642450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.49|STANDARD_ERROR_OF_MEAN|11.22||0.0363|TWO_SIDED|90.0|5.02|41.96||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||41.96|5.02|0.0363
71067029|NCT01164579|141642450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.4|STANDARD_ERROR_OF_MEAN|10.48||0.0005|TWO_SIDED|90.0|19.16|53.64||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||53.64|19.16|0.0005
71067030|NCT01164579|141642450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.27|STANDARD_ERROR_OF_MEAN|11.08||0.0177|TWO_SIDED|90.0|8.04|44.5||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||44.50|8.04|0.0177
71067031|NCT01164579|141642451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.52|STANDARD_ERROR_OF_MEAN|9.66||0.0197|TWO_SIDED|90.0|6.62|38.42||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||38.42|6.62|0.0197
71067032|NCT01164579|141642451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.33|STANDARD_ERROR_OF_MEAN|8.16||0.4379|TWO_SIDED|90.0|-7.09|19.76||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||19.76|-7.09|0.4379
71067033|NCT01164579|141642451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.37|STANDARD_ERROR_OF_MEAN|10.92||0.0093|TWO_SIDED|90.0|10.4|46.34||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||46.34|10.40|0.0093
71067034|NCT01164579|141642451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.48|STANDARD_ERROR_OF_MEAN|10.48||0.1669|TWO_SIDED|90.0|-2.75|31.73||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||31.73|-2.75|0.1669
71067035|NCT01164579|141642451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.37|STANDARD_ERROR_OF_MEAN|10.92||0.0093|TWO_SIDED|90.0|10.4|46.34||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||46.34|10.40|0.0093
71067036|NCT01164579|141642451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.04|STANDARD_ERROR_OF_MEAN|10.64||0.0596|TWO_SIDED|90.0|2.53|37.55||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||37.55|2.53|0.0596
71067037|NCT01164579|141642451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.73|STANDARD_ERROR_OF_MEAN|11.07||0.0017|TWO_SIDED|90.0|16.51|52.96||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||52.96|16.51|0.0017
71067038|NCT01164579|141642451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.52|STANDARD_ERROR_OF_MEAN|11.04||0.0097|TWO_SIDED|90.0|10.36|46.69||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||46.69|10.36|0.0097
71067039|NCT01164579|141642451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.97|STANDARD_ERROR_OF_MEAN|11.11||0.0016|TWO_SIDED|90.0|16.68|53.26||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||53.26|16.68|0.0016
71067040|NCT01164579|141642451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.6|STANDARD_ERROR_OF_MEAN|11.13||0.0102|TWO_SIDED|90.0|10.28|46.91||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||46.91|10.28|0.0102
71067041|NCT01164579|141642451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.73|STANDARD_ERROR_OF_MEAN|11.07||0.0017|TWO_SIDED|90.0|16.51|52.96||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||52.96|16.51|0.0017
71067042|NCT01164579|141642451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.97|STANDARD_ERROR_OF_MEAN|11.07||0.0381|TWO_SIDED|90.0|4.74|41.19||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||41.19|4.74|0.0381
71067043|NCT01164579|141642452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.77|STANDARD_ERROR_OF_MEAN|7.67||0.0959|TWO_SIDED|90.0|0.15|25.4||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||25.40|0.15|0.0959
71067044|NCT01164579|141642452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|5.4||0.9544|TWO_SIDED|90.0|-8.58|9.19||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||9.19|-8.58|0.9544
71067045|NCT01164579|141642452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.18|STANDARD_ERROR_OF_MEAN|9.34||0.0036|TWO_SIDED|90.0|11.81|42.55||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||42.55|11.81|0.0036
71067046|NCT01164579|141642452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.55|STANDARD_ERROR_OF_MEAN|7.66||0.264|TWO_SIDED|90.0|-4.04|21.16||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||21.16|-4.04|0.2640
71067047|NCT01164579|141642452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.83|STANDARD_ERROR_OF_MEAN|9.79||0.0544|TWO_SIDED|90.0|2.72|34.95||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||34.95|2.72|0.0544
71067048|NCT01164579|141642452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.7|STANDARD_ERROR_OF_MEAN|8.92||0.329|TWO_SIDED|90.0|-5.96|23.38||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||23.38|-5.96|0.3290
71067049|NCT01164579|141642452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.84|STANDARD_ERROR_OF_MEAN|10.48||0.0032|TWO_SIDED|90.0|13.59|48.09||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||48.09|13.59|0.0032
71067050|NCT01164579|141642452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.11|STANDARD_ERROR_OF_MEAN|9.92||0.0845|TWO_SIDED|90.0|0.79|33.43||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||33.43|0.79|0.0845
71067051|NCT01164579|141642452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.08|STANDARD_ERROR_OF_MEAN|10.72||0.0037|TWO_SIDED|90.0|13.44|48.72||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||48.72|13.44|0.0037
71067052|NCT01164579|141642452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.96|STANDARD_ERROR_OF_MEAN|10.36||0.054|TWO_SIDED|90.0|2.91|37.02||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||37.02|2.91|0.0540
71067053|NCT01164579|141642452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.54|STANDARD_ERROR_OF_MEAN|10.24||0.001|TWO_SIDED|90.0|16.7|50.39||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||50.39|16.70|0.0010
71067054|NCT01164579|141642452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.81|STANDARD_ERROR_OF_MEAN|9.66||0.0401|TWO_SIDED|90.0|3.92|35.71||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||35.71|3.92|0.0401
71067055|NCT01164579|141642453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.91|STANDARD_ERROR_OF_MEAN|10.99||0.0005|TWO_SIDED|90.0|19.83|55.99||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||55.99|19.83|0.0005
71067056|NCT01164579|141642453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.12|STANDARD_ERROR_OF_MEAN|11.09||0.0028|TWO_SIDED|90.0|14.87|51.38||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||51.38|14.87|0.0028
71067057|NCT01164579|141642453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.83|STANDARD_ERROR_OF_MEAN|10.1||0.0105|TWO_SIDED|90.0|9.21|42.45||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||42.45|9.21|0.0105
71067058|NCT01164579|141642453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.98|STANDARD_ERROR_OF_MEAN|11.13||0.37|TWO_SIDED|90.0|-8.33|28.3||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||28.30|-8.33|0.3700
71067059|NCT01164579|141642453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|39.82|STANDARD_ERROR_OF_MEAN|9.54|<|0.0001|TWO_SIDED|90.0|24.11|55.53||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||55.53|24.11|<0.0001
71067060|NCT01164579|141642453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.09|STANDARD_ERROR_OF_MEAN|11.24||0.1076|TWO_SIDED|90.0|-0.4|36.59||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||36.59|-0.40|0.1076
70938560|NCT01280656|141377513|SUPERIORITY_OR_OTHER|||||||0.573|TWO_SIDED||||||Chi-squared|||||||0.573
71067061|NCT01164579|141642453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.94|STANDARD_ERROR_OF_MEAN|10.21||0.0008|TWO_SIDED|90.0|17.13|50.75||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||50.75|17.13|0.0008
71067062|NCT01164579|141642453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.42|STANDARD_ERROR_OF_MEAN|10.74||0.0139|TWO_SIDED|90.0|8.74|44.1||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||44.10|8.74|0.0139
70938561|NCT01280656|141377515|SUPERIORITY_OR_OTHER|||||||0.982|TWO_SIDED||||||Chi-squared|||Mean at the site||||0.982
70938562|NCT01280656|141377515|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Chi-squared|||Mean at home||||0.012
70938563|NCT01280656|141377516|SUPERIORITY_OR_OTHER|||||||0.476|||||||t-test, 2 sided|||Responders vs Non-responders||||0.476
70938564|NCT01280656|141377516|SUPERIORITY_OR_OTHER|||||||0.32|||||||t-test, 2 sided|||Responders vs Non-Responders||||0.320
70938565|NCT01280656|141377517|SUPERIORITY_OR_OTHER|||||||0.792|TWO_SIDED||||||Chi-squared|||||||0.792
70938566|NCT01280656|141377518|SUPERIORITY_OR_OTHER|||||||0.202|TWO_SIDED||||||Chi-squared|||||||0.202
70938567|NCT01280656|141377519|SUPERIORITY_OR_OTHER|||||||0.921|TWO_SIDED||||||Chi-squared|||||||0.921
71067063|NCT01164579|141642453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.4|STANDARD_ERROR_OF_MEAN|10.48||0.0005|TWO_SIDED|90.0|19.16|53.64||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||53.64|19.16|0.0005
71067064|NCT01164579|141642453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.27|STANDARD_ERROR_OF_MEAN|11.08||0.0177|TWO_SIDED|90.0|8.04|44.5|||Normal approximation to the binomial|||Month 9||44.50|8.04|0.0177
71067065|NCT01164579|141642453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.46|STANDARD_ERROR_OF_MEAN|10.73||0.0018|TWO_SIDED|90.0|15.8|51.12||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||51.12|15.80|0.0018
71067066|NCT01164579|141642453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.49|STANDARD_ERROR_OF_MEAN|11.22||0.0363|TWO_SIDED|90.0|5.02|41.96||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||41.96|5.02|0.0363
71067067|NCT01164579|141642454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.88|STANDARD_ERROR_OF_MEAN|7.42||0.016|TWO_SIDED|90.0|5.66|30.1||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||30.10|5.66|0.0160
71067068|NCT01164579|141642454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.86|STANDARD_ERROR_OF_MEAN|5.43||0.2798|TWO_SIDED|90.0|-3.06|14.8||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||14.80|-3.06|0.2798
71112038|NCT01763333|141730831|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean)|gMean Ratio|86.16|||||TWO_SIDED|90.0|75.735|98.027|||||Adjusted geometric mean (gMean) ratio.|Relative bioavailability comparison Tab. fed (T1) : Tab. fasted (R1) for AUC 0-tz. The per protocol set for the evaluation of relative bioavailability of T1 vs R1 (PPS-BA-T1-R1) was used.||98.027|75.735|
70938568|NCT01280656|141377520|SUPERIORITY_OR_OTHER|||||||0.202|TWO_SIDED||||||Chi-squared|||||||0.202
71067069|NCT01164579|141642454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.18|STANDARD_ERROR_OF_MEAN|9.34||0.0036|TWO_SIDED|90.0|11.81|42.55||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||42.55|11.81|0.0036
71067070|NCT01164579|141642454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.78|STANDARD_ERROR_OF_MEAN|7.3||0.4287|TWO_SIDED|90.0|-6.23|17.79||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||17.79|-6.23|0.4287
71067071|NCT01164579|141642454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.83|STANDARD_ERROR_OF_MEAN|9.79||0.0544|TWO_SIDED|90.0|2.72|34.95||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||34.95|2.72|0.0544
70938569|NCT01280656|141377521|SUPERIORITY_OR_OTHER|||||||0.973|TWO_SIDED||||||Chi-squared|||Total||||0.973
70938570|NCT02138838|141377523|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|8.1||||0.48|TWO_SIDED|95.0|-13.7|29.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by baseline age group|SOC+Cinacalcet - SOC|||29.9|-13.7|0.48
70938571|NCT02138838|141377524|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-9.9||||0.42|TWO_SIDED|95.0|-33.3|13.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel stratified by baseline age group (6-\<12 years, 12-\<18 years)|SOC+Cinacalcet - SOC|A hierarchical testing procedure was used to test the primary and biochemical secondary endpoints. The primary endpoint was tested at a 2-sided significance level of 0.05. The secondary endpoints were tested using Holm's method at 0.05 (2-sided) should the primary endpoint achieve a significant result.||13.4|-33.3|0.42
70938572|NCT02138838|141377525|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-10.4||||0.25|TWO_SIDED|95.0|-27.7|6.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by baseline age group|SOC+Cinacalcet - SOC|||6.8|-27.7|0.25
70938573|NCT02138838|141377526|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|19.0||||0.23|TWO_SIDED|95.0|-12.5|50.5|||ANCOVA|Analysis of covariance (ANCOVA) with baseline age group as the covariate.|SOC+Cinacalcet - SOC|||50.5|-12.5|0.23
71067072|NCT01164579|141642454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.04|STANDARD_ERROR_OF_MEAN|9.51||0.0732|TWO_SIDED|90.0|1.39|32.69||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||32.69|1.39|0.0732
71067073|NCT01164579|141642454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.25|STANDARD_ERROR_OF_MEAN|10.61||0.036|TWO_SIDED|90.0|4.79|39.72||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||39.72|4.79|0.0360
71067074|NCT01164579|141642454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.85|STANDARD_ERROR_OF_MEAN|9.85||0.3688|TWO_SIDED|90.0|-7.35|25.07||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||25.07|-7.35|0.3688
70938574|NCT02138838|141377527|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-0.34||||0.059|TWO_SIDED|95.0|-0.7|0.01|||ANCOVA|Analysis of covariance (ANCOVA) with baseline age group as the covariate.||||0.01|-0.70|0.059
70938575|NCT02138838|141377528|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.76||||0.039|TWO_SIDED|95.0|0.04|1.48|||ANCOVA|Analysis of covariance (ANCOVA) with baseline age group as the covariate.|SOC+Cinacalcet - SOC|||1.48|0.04|0.039
70938576|NCT00780741|141377529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.09|TWO_SIDED|95.0|-0.01|0.21|||Point estimate on mean difference|Bootstrap sampling with replacement (N=10,000) was used to calculate the 95% confidence interval.|Mean difference calculated as the proportion with success in immediate group minus proportion with success in deferred group. 95% confidence interval obtained using bootstrap sampling with replacement.|||0.21|-0.01|0.09
70852726|NCT01578850|141194338|SUPERIORITY_OR_OTHER||Difference in proportions|11.4||||0.111|TWO_SIDED|95.0|3.31|19.51|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 20: Week 36||19.51|3.31|0.111
71067075|NCT01164579|141642454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.19|STANDARD_ERROR_OF_MEAN|10.67||0.0182|TWO_SIDED|90.0|7.63|42.76||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||42.76|7.63|0.0182
71067076|NCT01164579|141642454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.41|STANDARD_ERROR_OF_MEAN|10.15||0.1558|TWO_SIDED|90.0|-2.29|31.12||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||31.12|-2.29|0.1558
71067077|NCT01164579|141642454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.78|STANDARD_ERROR_OF_MEAN|10.49||0.0012|TWO_SIDED|90.0|16.51|51.05||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||51.05|16.51|0.0012
71067078|NCT01164579|141642454|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.33|STANDARD_ERROR_OF_MEAN|9.78||0.1426|TWO_SIDED|90.0|-1.74|30.42||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||30.42|-1.74|0.1426
71067079|NCT01164579|141642455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.88|STANDARD_ERROR_OF_MEAN|4.03||0.1449|TWO_SIDED|90.0|-0.75|12.52||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||12.52|-0.75|0.1449
71067080|NCT01164579|141642455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.85|STANDARD_ERROR_OF_MEAN|2.81||0.3102|TWO_SIDED|90.0|-1.77|7.48||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||7.48|-1.77|0.3102
71067081|NCT01164579|141642455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.94|STANDARD_ERROR_OF_MEAN|7.06||0.0342|TWO_SIDED|90.0|3.32|26.55||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||26.55|3.32|0.0342
71067082|NCT01164579|141642455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.85|STANDARD_ERROR_OF_MEAN|4.65||0.54|TWO_SIDED|90.0|-4.8|10.51||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||10.51|-4.80|0.5400
71067083|NCT01164579|141642455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.01|STANDARD_ERROR_OF_MEAN|9.19||0.2759|TWO_SIDED|90.0|-5.1|25.13||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||25.13|-5.10|0.2759
71067084|NCT01164579|141642455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.73|STANDARD_ERROR_OF_MEAN|6.25||0.0859|TWO_SIDED|90.0|-21.02|-0.45||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||-0.45|-21.02|0.0859
71067085|NCT01164579|141642455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.89|STANDARD_ERROR_OF_MEAN|9.62||0.0985|TWO_SIDED|90.0|0.06|31.73||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||31.73|0.06|0.0985
71067086|NCT01164579|141642455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|8.05||0.9628|TWO_SIDED|90.0|-12.86|13.61||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||13.61|-12.86|0.9628
71067087|NCT01164579|141642455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.07|STANDARD_ERROR_OF_MEAN|10.19||0.0612|TWO_SIDED|90.0|2.31|35.84||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||35.84|2.31|0.0612
71067088|NCT01164579|141642455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.32|STANDARD_ERROR_OF_MEAN|8.36||0.7807|TWO_SIDED|90.0|-16.08|11.43||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||11.43|-16.08|0.7807
71067089|NCT01164579|141642455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.83|STANDARD_ERROR_OF_MEAN|9.79||0.0544|TWO_SIDED|90.0|2.72|34.95||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||34.95|2.72|0.0544
71067090|NCT01164579|141642455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.93|STANDARD_ERROR_OF_MEAN|8.66||0.4937|TWO_SIDED|90.0|-8.32|20.18||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||20.18|-8.32|0.4937
71067091|NCT01605552|141642456|SUPERIORITY|||||||0.21|||||||ANCOVA||||Cohen's d = 0.61|||.21
71067092|NCT01605552|141642457|SUPERIORITY|||||||0.019|||||||ANCOVA||||Cohen's d = 1.33|||.019
71067093|NCT01605552|141642458|SUPERIORITY|||||||0.09|||||||ANCOVA||||Cohen's d = 0.78|||.09
71067094|NCT01605552|141642459|SUPERIORITY|||||||0.43|||||||ANCOVA||||Cohen's d = 0.43|||.43
71067095|NCT03491462|141642460|SUPERIORITY|||||||0.6208|||||||Gehan's extended Wilcoxon's test|||||||0.6208
71067096|NCT01050582|141642467|SUPERIORITY_OR_OTHER||Slope|0.447|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|0.22|0.674|||Regression, Linear|Covariates: weight (wt) divided expected wt for age and height (ht), age, use of concomitant medication with growth effects, preexposure ht z-score.|Slope associated with treatment dummy variable with 1 indicating risperidone and 0 indicating other atypical antipychotics.|Null hypothesis is that there is no difference between the risperidone and other atypical antipsychotics groups in current height z-score.||0.674|0.220|<0.001
71067097|NCT01050582|141642468|SUPERIORITY_OR_OTHER||Slope|-0.221|STANDARD_ERROR_OF_MEAN|0.25||0.378|TWO_SIDED|95.0|-0.711|0.269|||Regression, Linear|Covariates: Tanner stage and gender|Slope associated with treatment dummy variable with 1 indicating risperidone and 0 indicating other atypical antipsychotics.|The null hypothesis is that there is no difference between the risperidone and other atypical antipsychotics groups in age (years) at current Tanner stage.||0.269|-0.711|0.378
71067098|NCT01050582|141642469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.865|||>|0.999||95.0|0.189|3.963|||Fisher Exact||Estimated OR is from a logistic regression model including factors for treatment arm, age, indication, and use of concomitant medication with growth effects.|Null hypothesis is that there is no difference between the risperidone and other atypical antipsychotics groups in frequency of retrospectively reported potentially prolactin-related adverse events||3.963|0.189|>0.999
71067099|NCT03935425|141642492|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
71067100|NCT00885664|141642503|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||||||0.45
71067101|NCT00885664|141642504|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71067102|NCT00885664|141642505|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
71067103|NCT00885664|141642506|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||||||0.81
71067104|NCT00885664|141642507|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||||||0.99
71067105|NCT00885664|141642508|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
71067106|NCT00885664|141642509|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
70938577|NCT00780741|141377530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-139.0||||0.24|TWO_SIDED|95.0|-377.0|94.0|||Point estimate on mean difference|Bootstrap sampling with replacement (N=10,000) was used to calculate the 95% confidence interval.|Mean difference calculated as the average cost in immediate group minus average cost in deferred group. 95% confidence interval obtained using bootstrap sampling with replacement.|||94|-377|0.24
70938578|NCT00780741|141377531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|||<|0.0001|TWO_SIDED|95.0|-4.0|-1.8|||Point estimate on mean difference|Bootstrap sampling with replacement (N=10,000) was used to calculate the 95% confidence interval.|Mean difference calculated as the average months of symptoms in immediate group minus average months of symptoms in deferred group. 95% confidence interval obtained using bootstrap sampling with replacement.|||-1.8|-4.0|<0.0001
71067107|NCT00885664|141642510|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71067108|NCT00885664|141642511|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71067109|NCT00885664|141642512|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
71067110|NCT00885664|141642513|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
71067111|NCT01562782|141642527|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups in the primary outcome- the mean fold change in plasma VLDL triglyceride palmitate, 0-4 hours. A power calculation was based on data obtained in 15 overweight subjects. Assuming a mean absolute difference of 2.7 in South Asians and 1.0 in Caucasians and a standard deviation of 2.0 for both, group sample sizes of 16 and 16 were expected to achieve 80% power to detect a difference of 1.7 using a 2-sided Mann-Whitney test.|Mean Difference (Final Values)|0.61||||0.05|TWO_SIDED||||||Mixed Models Analysis|||The equivalence test was used to compare the fold change in plasma VLDL triglyceride palmitate in Caucasians and South Asians.||||0.05
71067112|NCT01562782|141642528|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||The equivalence test was used to compare 1) the fold change in triglycerides in South Asians and Caucasians and 2) the fold change in VLDL triglycerides in South Asians and Caucasians.||||<0.05
71067113|NCT01562782|141642529|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||The equivalence test is used to compare levels after the sugar beverage of 1) glucose at 1 hour 2) lactate at 1 hour 3) NEFA at 2 hours in South Asians vs Caucasians.||||<0.05
71067114|NCT01562782|141642530|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71067115|NCT01562782|141642531|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71067116|NCT01562782|141642532|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||Pearson or Spearman's rank test|||The equivalence test was used to analyze the relationship between the primary outcome, fold change in VLDL TG palmitate, and the listed levels of biomarkers of carbohydrate and fat metabolism. The correlation analysis was performed on data from each study group separately.||||<0.05
71067117|NCT01562782|141642533|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71067118|NCT01562782|141642534|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71067119|NCT01562782|141642535|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71067120|NCT01562782|141642536|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71067121|NCT00911612|141642539|SUPERIORITY_OR_OTHER|||||||0.22||95.0||||Not adjusted since only one comparison was made.|ANCOVA|||An analysis of covariance was used to compare drug with placebo adjusting for baseline geometric center at 24 hours , BMI, and 7 alpha CHO.||||0.22
71067122|NCT00911612|141642540|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANCOVA|||An analysis of covariance was used to compare drug with placebo adjusting for BMI and 7 alpha HCO.||||0.02
71067123|NCT00945035|141642544|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Study Primary Hypothesis: The plasma etoricoxib AUC(0-∞) and Cmax values following a single-dose administration of the 120 mg etoricoxib (30%) URC formulation will be bioequivalent to the plasma AUC(0-∞) and Cmax of 120 mg etoricoxib (20%) in the FMI formulation following single-dose administration (geometric mean ratio \[GMR\] no less than 0.8 and no greater than 1.25).|Least-Squares Mean Ratio|1.02||||||90.0|0.97|1.07||||||Least-Squares Mean Ratio (B/A); A=FMI Formulation (20%), Final Market Image; B=URC Formulation (30%), Unmilled Roller Compaction||1.07|0.97|
71067124|NCT00945035|141642545|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Study Primary Hypothesis: The plasma etoricoxib AUC(0-∞) and Cmax values following a single-dose administration of the 120 mg etoricoxib (30%) URC formulation will be bioequivalent to the plasma AUC(0-∞) and Cmax of 120 mg etoricoxib (20%) in the FMI formulation following single-dose administration (geometric mean ratio \[GMR\] no less than 0.8 and no greater than 1.25).|Least-Squares Mean Ratio|1.03||||||90.0|0.95|1.11||||||Least-Squares Mean Ratio (B/A); A=FMI Formulation (20%), Final Market Image; B=URC Formulation (30%), Unmilled Roller Compaction||1.11|0.95|
71067125|NCT01908829|141642560|SUPERIORITY||Least Squares (LS) Means|-0.26|STANDARD_ERROR_OF_MEAN|0.11|=|0.001|TWO_SIDED|95.0|-0.47|-0.05||P values for pairwise comparisons were from the stratified rank ANCOVA model. P \< 0.05 indicated superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group based on ANCOVA model. Means (LS means) and 95% Confidence Intervals (CIs) are from an ANCOVA model with sex, age group (\< 65, ≥ 65 years), geographic region, and 4-week incontinence episode reduction group as fixed factors and mean number of incontinence episodes per 24 hours at baseline as a covariate.||-0.05|-0.47|=0.001
70938579|NCT01867307|141377558|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-220.0|STANDARD_ERROR_OF_MEAN|55.5|<|0.0001|TWO_SIDED|95.0|-440.6|-202.7||P-value is from a paired t-test.|Paired t- test||Difference calculated as (Day 14 - baseline) values|Point estimates of the changes from baseline and 95% Confidence interval around the estimates on treatment day 14 were computed.||-202.7|-440.6|<0.0001
70938580|NCT01867307|141377558|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-234.0|STANDARD_ERROR_OF_MEAN|25.8|<|0.0001|TWO_SIDED|95.0|-312.3|-201.5||P-value is from a paired t-test|Paired t-test||Difference calculated as (Day 14 - baseline) values|Point estimates of the changes from baseline and 95% Confidence interval around the estimates on treatment day 14 were computed.||-201.5|-312.3|<0.0001
70938581|NCT00623714|141377564|SUPERIORITY_OR_OTHER||Geometric Mean Fold Difference|0.34||||0.011|TWO_SIDED|90.0|0.16|0.7||1-sided, alpha = 0.05|ANOVA|Analysis performed on log-transformed fold change from baseline and results were back-transformed for reporting.||||0.70|0.16|0.011
70938582|NCT00623714|141377565|SUPERIORITY_OR_OTHER||Geometric Mean Fold Difference|0.4||||0.002|TWO_SIDED|95.0|0.26|0.63||1-sided, alpha = 0.05|ANOVA|Analysis performed on log-transformed fold change from baseline and results were back-transformed for reporting.||||0.63|0.26|0.002
71078852|NCT01964716|141665735|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.28|||||TWO_SIDED|97.5|1.09|1.49||||||Serotype 18C: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.49|1.09|
71117672|NCT01559259|141740589|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.28|||<|0.001|TWO_SIDED|95.0|0.17|0.45||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||0.45|0.17|<0.001
70852727|NCT01578850|141194338|SUPERIORITY_OR_OTHER||Difference in proportions|10.1||||0.175|TWO_SIDED|95.0|1.8|18.49|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 20: Week 44||18.49|1.80|0.175
70938583|NCT00234832|141377609|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.162||||0.015|TWO_SIDED|95.0|1.029|1.311||No adjustment for multiple testing or interim analysis was performed. The primary outcome was tested at a 2-sided alpha level of 0.05.|Log Rank||The Cox model included factors for treatment, country, gender, and age (continuous) at Lead-in Period baseline. For the calculation of risk, the sibutramine arm is the numerator and the placebo arm is the denominator.|For the sample size calculation, a two-tailed alpha level of 0.05 was used along with power of 90%. The annual composite event rate in the placebo arm was assumed to be 7.0%. A sample of 3983 subjects in each of the 2 groups, corrected for a 30% noncompliance rate (15% in Year 1 and 6.3% in each year, Years 2 to 4), followed for at least 3 years was expected to have 90% power to detect a relative risk reduction of 15% with sibutramine relative to placebo.||1.311|1.029|0.015
70938584|NCT00234832|141377609|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.01||||0.948|TWO_SIDED|95.0|0.738|1.384|||Log Rank|||This analysis included only subjects with DM only in a comparison of sibutramine and placebo.||1.384|0.738|0.948
70938585|NCT00234832|141377609|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.276||||0.149|TWO_SIDED|95.0|0.916|1.776|||Log Rank|||This analysis included only subjects with CV only in a comparison of sibutramine and placebo.||1.776|0.916|0.149
70938586|NCT00234832|141377609|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.182||||0.022|TWO_SIDED|95.0|1.024|1.365|||Log Rank|||This analysis included only subjects with CV + DM in a comparison of sibutramine and placebo.||1.365|1.024|0.022
70938587|NCT00234832|141377610|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.043||||0.543|TWO_SIDED|95.0|0.91|1.196|||Log Rank|||||1.196|0.910|0.543
70938588|NCT00234832|141377611|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.097||||0.051|TWO_SIDED|95.0|0.999|1.204|||Log Rank|||||1.204|0.999|0.051
70938589|NCT00234832|141377612|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.276||||0.022|TWO_SIDED|95.0|1.036|1.571|||Log Rank|||||1.571|1.036|0.022
70938590|NCT00234832|141377613|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.355||||0.025|TWO_SIDED|95.0|1.038|1.767|||Log Rank|||||1.767|1.038|0.025
70938591|NCT00234832|141377614|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.582||||0.343|TWO_SIDED|95.0|0.613|4.081|||Log Rank|||||4.081|0.613|0.343
70938592|NCT00234832|141377615|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.988||||0.899|TWO_SIDED|95.0|0.822|1.188|||Log Rank|||||1.188|0.822|0.899
70938593|NCT04454125|141377621|SUPERIORITY||Odds Ratio (OR)|0.61||||0.32|TWO_SIDED|95.0|0.23|1.61|||Generalized linear model, repeat measure|Generalized linear model (GLM) fitted with binomial distribution and logit link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group arm, visit, interaction term (arm\*visit) and adjusting for visit 2 severe asthma exacerbation.|Outcome= severe asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).||1.61|0.23|0.32
70938594|NCT04454125|141377621|SUPERIORITY||Odds Ratio (OR)|0.31||||0.29|TWO_SIDED|95.0|0.03|2.76|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the intervention group (AQI intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit) and adjusting for visit 2 severe asthma exacerbation.|Outcome= severe asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).||2.76|0.03|0.29
71078853|NCT01964716|141665735|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.01|||||TWO_SIDED|97.5|0.82|1.24||||||Serotype 19A: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.24|0.82|
70852728|NCT01578850|141194338|SUPERIORITY_OR_OTHER||Difference in proportions|10.8||||0.088|TWO_SIDED|95.0|2.49|19.05|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 20: Week 52||19.05|2.49|0.088
71067126|NCT01908829|141642561|SUPERIORITY||LS Means|-0.33|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.52|-0.14||P values for pairwise comparisons are from the stratified rank ANCOVA model. P \< 0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 4 differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group based on ANCOVA model. Means (LS means) and 95% CIs are from an ANCOVA model with sex, age group (\< 65, ≥ 65 years), geographic region, and 4-week incontinence episode reduction group as fixed factors and mean number of incontinence episodes per 24 hours at baseline as a covariate.||-0.14|-0.52|<0.001
71067127|NCT01908829|141642561|SUPERIORITY||LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.18||P values for pairwise comparisons are from the stratified rank ANCOVA model. P \< 0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 8 differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group based on ANCOVA model. Means (LS means) and 95% CIs are from an ANCOVA model with sex, age group (\< 65, ≥ 65 years), geographic region, and 4-week incontinence episode reduction group as fixed factors and mean number of incontinence episodes per 24 hours at baseline as a covariate.||-0.18|-0.60|<0.001
71067128|NCT01908829|141642561|SUPERIORITY||LS Means|-0.25|STANDARD_ERROR_OF_MEAN|0.11|=|0.001|TWO_SIDED|95.0|-0.46|-0.03||P-values for pairwise comparisons are from the stratified rank ANCOVA model. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 12 differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group based on ANCOVA model. Means (LS means) and 95% CIs are from an ANCOVA model with sex, age group (\< 65, ≥ 65 years), geographic region, and 4-week incontinence episode reduction group as fixed factors and mean number of incontinence episodes per 24 hours at baseline as a covariate.||-0.03|-0.46|=0.001
71067129|NCT01908829|141642562|SUPERIORITY||LS Means|-0.26|STANDARD_ERROR_OF_MEAN|0.1|=|0.01|TWO_SIDED|95.0|-0.47|-0.06||P-values for pairwise comparisons are from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.06|-0.47|=0.010
71067130|NCT01908829|141642562|SUPERIORITY||LS Means|-0.42|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.65|-0.19||P-values for pairwise comparisons are from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.19|-0.65|<0.001
71067131|NCT01908829|141642562|SUPERIORITY||LS Means|-0.47|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.7|-0.23||P-values for pairwise comparisons are from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.23|-0.70|<0.001
71067132|NCT01908829|141642562|SUPERIORITY||LS Means|-0.45|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.67|-0.22||P-values for pairwise comparisons are from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.22|-0.67|<0.001
71067133|NCT01908829|141642563|SUPERIORITY||Rate Ratio|0.87|STANDARD_ERROR_OF_MEAN|0.05|=|0.005|TWO_SIDED|95.0|0.79|0.96||p\<0.05 indicates superiority in favor of treatment group with lowest rate of incontinence episodes.|Mixed Effects Poisson|||Week 4 rate ratio, 95% CIs, \& p-value for number of incontinence episodes (IEs) during Week 4 3-day diary between combination \& solifenacin treatment was calculated from Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week IE reduction group as factors, log of (number of IEs/valid diary days) at baseline as covariate \& log of number of valid diary days as the offset variable.||0.96|0.79|=0.005
71067134|NCT01908829|141642563|SUPERIORITY||Rate Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|0.66|0.86||p\<0.05 indicates superiority in favor of treatment group with lowest rate of incontinence episodes.|Mixed Effects Poisson|||Week 8 rate ratio, 95% CIs, \& p-value for number of incontinence episodes (IEs) during Week 8 3-day diary between combination \& solifenacin treatment was calculated from Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week IE reduction group as factors, log of (number of IEs/valid diary days) at baseline as covariate \& log of number of valid diary days as the offset variable.||0.86|0.66|<0.001
70852729|NCT01578850|141194338|SUPERIORITY_OR_OTHER||Difference in proportions|2.5||||0.584|TWO_SIDED|95.0|-4.78|9.75|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 50: Week 24||9.75|-4.78|0.584
71112039|NCT01763333|141730831|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean)|gMean ratio|74.42|||||TWO_SIDED|90.0|65.979|83.941|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2) : Sol. fasted (R2) for AUC 0-tz.The per protocol set for the evaluation of relative bioavailability of T2 vs R2 (PPS-BA-T2-R2) was used.||83.941|65.979|
71112040|NCT01763333|141730831|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|137.2|||||TWO_SIDED|90.0|119.611|157.374|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fasted (R2): Tab. fasted (R1) for AUC 0-tz.The per protocol set for the evaluation of relative bioavailability of R2 vs R1(PPS-BA-R2-R1) was used.||157.374|119.611|
71112041|NCT01763333|141730831|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|116.83|||||TWO_SIDED|90.0|111.814|122.079|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2): Tab. fed (T1) for AUC 0-tz.The per protocol set for the evaluation of relative bioavailability of T2 vs T1 (PPS-BA-T2-T1) was used.||122.079|111.814|
71112042|NCT00556439|141730857|OTHER|Kaplan-Meier curves of relapse free survival were constructed, and differences in treatment arms compared using the logrank test. The analysis of the primary outcome was based upon intent to treat.||||||0.049||||||The p value of 0.049 reflects comparison of relapse free survival of abatacept versus placebo in giant cell arteritis.|Log Rank|||The planned sample size was determined by the minimally clinically meaningful result (i.e., an approximate 30% improvement in relapse-free survival) to be detected utilizing a one-sided alpha of 0.1. Kaplan-Meier curves of RFS were constructed for each stratum, and differences in treatment arms compared using the logrank test. The analysis of the primary outcome was based upon intent to treat.||||0.049
71112043|NCT00556439|141730857|OTHER|Kaplan-Meier curves of relapse free survival were constructed, and differences in treatment arms compared using the logrank test. The analysis of the primary outcome was based upon intent to treat.||||||0.853||||||The p value of 0.853 reflects comparison of relapse free survival of abatacept versus placebo in Takayasu arteritis.|Log Rank|||The planned sample size was determined by the minimally clinically meaningful result (i.e., an approximate 30% improvement in relapse-free survival) to be detected utilizing a one-sided alpha of 0.1. Kaplan-Meier curves of RFS were constructed for each stratum, and differences in treatment arms compared using the logrank test. The analysis of the primary outcome was based upon intent to treat.||||0.853
71112044|NCT02931838|141730864|SUPERIORITY|||||||0.4873||||||Nominal p-value|Chi-squared|P-value is from the Fishers Exact if at least one cell count is \<5. Otherwise, p-value is from the Chi-Square test.||||||0.4873
71112045|NCT02931838|141730864|SUPERIORITY|||||||0.0003||||||Nominal p-value|Chi-squared|P-value is from the Fishers Exact if at least one cell count is \<5. Otherwise, p-value is from the Chi-Square test.||||||0.0003
71112046|NCT02931838|141730864|SUPERIORITY||||||<|0.0001||||||Nominal p-value|Chi-squared|P-value is from the Fishers Exact if at least one cell count is \<5. Otherwise, p-value is from the Chi-Square test.||||||<0.0001
71112047|NCT02931838|141730864|SUPERIORITY||||||<|0.0001||||||Nominal p-value|Chi-squared|P-value is from the Fishers Exact if at least one cell count is \<5. Otherwise, p-value is from the Chi-Square test.||||||< 0.0001
71112048|NCT02931838|141730864|SUPERIORITY||||||<|0.0001||||||Nominal p-value|Chi-squared|P-value is from the Fishers Exact if at least one cell count is \<5. Otherwise, p-value is from the Chi-Square test.||||||<0.0001
70852730|NCT01578850|141194338|SUPERIORITY_OR_OTHER||Difference in proportions|11.5||||0.226|TWO_SIDED|95.0|1.59|21.34|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 50: Week 28||21.34|1.59|0.226
71112049|NCT03419897|141730896|SUPERIORITY|||||||0.0001|||||||Binomial exact test|||Tislelizumab compared with historical ORR rate of 7%||||0.0001
71112050|NCT03759639|141730913|SUPERIORITY||Hodges-Lehmann Estimator|1.0||||0.029|TWO_SIDED|90.0|0.25|1.75|||1-sided Wilcoxon signed-rank test|||||1.75|0.25|0.029
71112051|NCT03759639|141730915|SUPERIORITY||Hodges-Lehmann Estimator|0.13||||0.318|TWO_SIDED|90.0|-0.25|0.5|||1-sided Wilcoxon signed-rank test|||||0.50|-0.25|0.318
71112052|NCT03759639|141730918|SUPERIORITY||Hodges-Lehmann Estimator|0.0854||||0.084|TWO_SIDED|90.0|-0.0123|0.1777|||1-sided Wilcoxon signed-rank test|||Treatment With IB1001||0.1777|-0.0123|0.084
71112053|NCT03759639|141730918|SUPERIORITY||Hodges-Lehmann Estimator|-0.0399||||0.315|TWO_SIDED|90.0|-0.1269|0.1031|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||0.1031|-0.1269|0.315
71112054|NCT03759639|141730919|SUPERIORITY||Hodges-Lehmann Estimator|-1.25||||0.001|TWO_SIDED|90.0|-1.75|-0.5|||1-sided Wilcoxon signed-rank test|||Treatment With IB1001||-0.50|-1.75|0.001
71112055|NCT03759639|141730919|SUPERIORITY||Hodges-Lehmann Estimator|1.25||||0.002|TWO_SIDED|90.0|0.5|2.0|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||2.00|0.50|0.002
71112056|NCT03759639|141730921|SUPERIORITY||Hodges-Lehmann Estimator|0.0||||0.121|TWO_SIDED|90.0|-0.021|0.0|||1-sided Wilcoxon signed-rank test|||Treatment with IB1001||0.000|-0.021|0.121
71112057|NCT03759639|141730921|SUPERIORITY||Hodges-Lehmann Estimator|0.021||||0.056|TWO_SIDED|90.0|0.0|0.042|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||0.042|0.000|0.056
71112058|NCT03759639|141730922|SUPERIORITY||Mean Difference (Net)|3.4|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Treatment With IB1001||||<0.001
71112059|NCT03759639|141730922|SUPERIORITY||Mean Difference (Net)|4.5||||0.006|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Post-Treatment Washout||||0.006
71112060|NCT03759639|141730923|SUPERIORITY||Mean Difference (Net)|3.4||||0.005|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Treatment With IB1001||||0.005
71067135|NCT01908829|141642563|SUPERIORITY||Rate Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.08|=|0.021|TWO_SIDED|95.0|0.7|0.97||p\<0.05 indicates superiority in favor of treatment group with lowest rate of incontinence episodes.|Mixed Effects Poisson|||Week 12 rate ratio, 95% CIs, \& p-value for number of incontinence episodes (IEs) during Week 12 3-day diary between combination \& solifenacin treatment was calculated from Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week IE reduction group as factors, log of (number of IEs/valid diary days) at baseline as covariate \& log of number of valid diary days as the offset variable.||0.97|0.70|=0.021
71112061|NCT03759639|141730923|SUPERIORITY||Mean Difference (Net)|4.4||||0.038|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Treatment With IB1001||||0.038
71112062|NCT03759639|141730924|SUPERIORITY||Mean Difference (Net)|3.3||||0.003|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Treatment with IB1001||||0.003
71067136|NCT01908829|141642563|SUPERIORITY||Rate Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.08|=|0.014|TWO_SIDED|95.0|0.71|0.96||p\<0.05 indicates superiority in favor of treatment group with lowest rate of incontinence episodes.|Mixed Effects Poisson|||EoT rate ratio, 95% CIs, \& p-value for number of incontinence episodes (IEs) during EoT 3-day diary between combination \& solifenacin treatment was calculated from Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week IE reduction group as factors, log of (number of IEs/valid diary days) at baseline as covariate \& log of number of valid diary days as the offset variable.||0.96|0.71|=0.014
71067137|NCT01908829|141642564|SUPERIORITY||LS Means|3.86|STANDARD_ERROR_OF_MEAN|2.19|<|0.078|TWO_SIDED|95.0|-0.43|8.16||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||8.16|-0.43|<0.078
71067138|NCT01908829|141642564|SUPERIORITY||LS Means|11.19|STANDARD_ERROR_OF_MEAN|2.66|<|0.001|TWO_SIDED|95.0|5.98|16.4||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||16.40|5.98|<0.001
71067139|NCT01908829|141642564|SUPERIORITY||LS Means|12.38|STANDARD_ERROR_OF_MEAN|2.92|<|0.001|TWO_SIDED|95.0|6.65|18.12||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||18.12|6.65|<0.001
71112063|NCT03759639|141730924|SUPERIORITY||Mean Difference (Net)|4.4||||0.034|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Post-Treatment Washout||||0.034
70852731|NCT01578850|141194338|SUPERIORITY_OR_OTHER||Difference in proportions|17.2||||0.012|TWO_SIDED|95.0|6.76|27.56|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 50: Week 36||27.56|6.76|0.012
70852732|NCT01578850|141194338|SUPERIORITY_OR_OTHER||Difference in proportions|19.0||||0.006|TWO_SIDED|95.0|8.59|29.35|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 50: Week 44||29.35|8.59|0.006
71112064|NCT00958360|141730925|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.05
71112065|NCT00958360|141730926|SUPERIORITY_OR_OTHER|||||||0.13|||||||t-test, 2 sided|||||||0.13
71112066|NCT00958360|141730927|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.05
71112067|NCT00958360|141730928|SUPERIORITY_OR_OTHER|||||||0.013|||||||t-test, 2 sided|||||||0.013
71112068|NCT00958360|141730929|SUPERIORITY_OR_OTHER|||||||0.013|||||||t-test, 2 sided|||||||0.013
71112069|NCT00336284|141730932|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71112070|NCT00336284|141730933|NON_INFERIORITY_OR_EQUIVALENCE|Sample size of the study is based on the safety endpoint and based on a Blackwelder type test of non inferiority with the standard design criteria: Type I error (one-sided), statistical power of 80%, and 2:1 randomization. The evaluation of the primary safety endpoint was based on an exact binomial non-inferiority test comparing the proportions of patient deaths, strokes or surgical interventions.||||||0.005||95.0|||||Exact binomial test for non-inferiority|1-sided||||||0.005
71112071|NCT00336284|141730934|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||t-test, 2 sided|||||||0.016
71112072|NCT03308968|141730942|OTHER||Least square (LS) mean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-3.84|-2.42|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) method with treatment, sex, region, special group of treatment failure (yes or no), migraine classification (that is; CM or EM), and treatment-by-migraine classification interaction as fixed effects, and baseline number of migraine days and years since onset of migraines as covariates. The stratification factors (as randomized) were used in the model.||-2.42|-3.84|<0.0001
70852733|NCT01578850|141194338|SUPERIORITY_OR_OTHER||Difference in Proportions|17.7||||0.014|TWO_SIDED|95.0|7.3|28.16|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 50: Week 52||28.16|7.30|0.014
71067140|NCT01908829|141642564|SUPERIORITY||LS Means|11.52|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|6.06|16.99||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||16.99|6.06|<0.001
71067141|NCT01908829|141642565|SUPERIORITY||LS Means|-0.44|STANDARD_ERROR_OF_MEAN|0.15|=|0.003|TWO_SIDED|95.0|-0.73|-0.16||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.16|-0.73|=0.003
71067142|NCT01908829|141642566|SUPERIORITY||LS Means|-0.35|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.54|-0.17||P-values for pairwise comparisons were from stratified rank ANCOVA model. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.17|-0.54|<0.001
71067143|NCT01908829|141642566|SUPERIORITY||LS Means|-0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.65|-0.25||P-values for pairwise comparisons were from stratified rank ANCOVA model. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 8 djusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.25|-0.65|<0.001
71067144|NCT01908829|141642566|SUPERIORITY||LS Means|-0.26|STANDARD_ERROR_OF_MEAN|0.11|=|0.004|TWO_SIDED|95.0|-0.47|-0.05||P-values for pairwise comparisons were from stratified rank ANCOVA model. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.05|-0.47|=0.004
71067145|NCT01908829|141642566|SUPERIORITY||LS Means|-0.27|STANDARD_ERROR_OF_MEAN|0.1|=|0.003|TWO_SIDED|95.0|-0.47|-0.07||P-values for pairwise comparisons were from stratified rank ANCOVA model. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.07|-0.47|=0.003
71067146|NCT01908829|141642567|SUPERIORITY||Rate Ratio|0.85|STANDARD_ERROR_OF_MEAN|0.05|=|0.003|TWO_SIDED|95.0|0.76|0.94||p\<0.05 indicates superiority in favor of treatment group with lowest rate of UI episodes.|Mixed Effects Poisson|||Week 4 rate ratio, 95% CIs, and p-value for number of UI episodes during Week 4 3-day diary between combination and solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of UI episodes/number of valid diary days) at baseline as covariate and log of number of valid diary as the offset variable.||0.94|0.76|=0.003
71067147|NCT01908829|141642567|SUPERIORITY||Rate Ratio|0.74|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|0.63|0.86||p\<0.05 indicates superiority in favor of treatment group with lowest rate of UI episodes.|Mixed Effects Poisson|||Week 8 rate ratio, 95% CIs, and p-value for number of UI episodes during Week 8 3-day diary between combination and solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of UI episodes/number of valid diary days) at baseline as covariate and log of number of valid diary as the offset variable.||0.86|0.63|<0.001
71067148|NCT01908829|141642567|SUPERIORITY||Rate Ratio|0.83|STANDARD_ERROR_OF_MEAN|0.09|=|0.038|TWO_SIDED|95.0|0.69|0.99||p\<0.05 indicates superiority in favor of treatment group with lowest rate of UI episodes.|Mixed Effects Poisson|||Week 12 rate ratio, 95% CIs, and p-value for number of UI episodes during Week 12 3-day diary between combination and solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of UI episodes/number of valid diary days) at baseline as covariate and log of number of valid diary as the offset variable.||0.99|0.69|=0.038
71078854|NCT01964716|141665735|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.04|||||TWO_SIDED|97.5|0.85|1.26||||||Serotype 19F: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.26|0.85|
70938595|NCT04454125|141377621|SUPERIORITY||Odds Ratio (OR)|0.51||||0.58|TWO_SIDED|95.0|0.05|5.68|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link||Outcome= severe asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit) and adjusting for visit 2 severe asthma exacerbation.|5.68|0.05|0.58
70938596|NCT04454125|141377621|SUPERIORITY||Odds Ratio (OR)|0.5||||0.02|TWO_SIDED|95.0|0.27|0.91|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit) and adjusting for visit 2 moderate asthma exacerbation.|Outcome= moderate asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).||0.91|0.27|0.02
70938597|NCT04454125|141377621|SUPERIORITY||Odds Ratio (OR)|0.23||||0.03|TWO_SIDED|95.0|0.06|0.86|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit) and adjusting for visit 2 moderate asthma exacerbation.|Outcome= moderate asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).||0.86|0.06|0.03
70938598|NCT04454125|141377621|SUPERIORITY||Odds Ratio (OR)|0.47||||0.3|TWO_SIDED|95.0|0.11|1.95|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit) and adjusting for visit 2 moderate asthma exacerbation.|Outcome= moderate asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).||1.95|0.11|0.30
70938599|NCT04454125|141377622|SUPERIORITY||Mean Difference (Net)|0.17||||0.8|TWO_SIDED|95.0|-1.17|1.51|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome=Asthma Control Test Score. Obtained at all visits.||1.51|-1.17|0.80
70938600|NCT04454125|141377622|SUPERIORITY||Mean Difference (Net)|2.02||||0.001|TWO_SIDED|95.0|0.88|3.15|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome=Asthma Control Test Score. Obtained at all visits.||3.15|0.88|0.001
70938601|NCT04454125|141377622|SUPERIORITY||Mean Difference (Net)|1.85||||0.04|TWO_SIDED|95.0|0.09|3.61|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome=Asthma Control Test Score. Obtained at all visits.||3.61|0.09|0.04
71067149|NCT01908829|141642567|SUPERIORITY||Rate Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.09|=|0.022|TWO_SIDED|95.0|0.69|0.97||p\<0.05 indicates superiority in favor of treatment group with lowest rate of UI episodes.|Mixed Effects Poisson|||EoT rate ratio, 95% CIs, and p-value for number of UI episodes during EoT 3-day diary between combination and solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of UI episodes/number of valid diary days) at baseline as covariate and log of number of valid diary as the offset variable.||0.97|0.69|=0.022
71067150|NCT01908829|141642568|SUPERIORITY||LS Means|-0.45|STANDARD_ERROR_OF_MEAN|0.13|=|0.001|TWO_SIDED|95.0|-0.72|-0.19||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.19|-0.72|=0.001
71078855|NCT01964716|141665735|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.2|||||TWO_SIDED|97.5|0.98|1.48||||||Serotype 23F: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.48|0.98|
71078856|NCT01964716|141665744|SUPERIORITY_OR_OTHER||percent difference|-7.7|||||TWO_SIDED|95.0|-17.2|1.9||||||Serotype 1: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||1.9|-17.2|
71078857|NCT01964716|141665744|SUPERIORITY_OR_OTHER||percent difference|-1.2|||||TWO_SIDED|95.0|-4.4|1.1||||||Serotype 3: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||1.1|-4.4|
71078858|NCT01964716|141665744|SUPERIORITY_OR_OTHER||percent difference|0.0|||||TWO_SIDED|95.0|-2.3|2.3||||||Serotype 4: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.3|-2.3|
71078859|NCT01964716|141665744|SUPERIORITY_OR_OTHER||percent difference|-2.4|||||TWO_SIDED|95.0|-10.6|5.7||||||Serotype 5: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||5.7|-10.6|
71078860|NCT01964716|141665744|SUPERIORITY_OR_OTHER||percent difference|0.0|||||TWO_SIDED|95.0|-2.9|2.8||||||Serotype 6A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.8|-2.9|
71078861|NCT01964716|141665744|SUPERIORITY_OR_OTHER||percent difference|0.0|||||TWO_SIDED|95.0|-4.5|4.6||||||Serotype 6B: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||4.6|-4.5|
71112073|NCT03308968|141730942|OTHER||LS mean difference|-3.5|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-4.19|-2.78|||ANCOVA|||Analysis was performed using ANCOVA method with treatment, sex, region, special group of treatment failure (yes or no), migraine classification (that is; CM or EM), and treatment-by-migraine classification interaction as fixed effects, and baseline number of migraine days and years since onset of migraines as covariates. The stratification factors (as randomized) were used in the model.||-2.78|-4.19|<0.0001
71112074|NCT02482298|141730980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.06367|||TWO_SIDED|90.0|-0.061|0.151|||Mixed Models Analysis|||||0.1510|-0.0610|
71112075|NCT02482298|141730980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0801|STANDARD_ERROR_OF_MEAN|0.06192|||TWO_SIDED|90.0|-0.023|0.1832|||Mixed Models Analysis|||||0.1832|-0.0230|
71112076|NCT02482298|141730982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1192|STANDARD_ERROR_OF_MEAN|0.05059|||TWO_SIDED|90.0|0.035|0.2035|||Mixed Models Analysis|||||0.2035|0.0350|
71067151|NCT01908829|141642568|SUPERIORITY||LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.93|-0.35||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.35|-0.93|<0.001
71067152|NCT01908829|141642568|SUPERIORITY||LS Means|-0.52|STANDARD_ERROR_OF_MEAN|0.15|=|0.001|TWO_SIDED|95.0|-0.82|-0.22||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.22|-0.82|=0.001
71067153|NCT01908829|141642568|SUPERIORITY||LS Means|-0.54|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.83|-0.25||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.25|-0.83|<0.001
71067154|NCT01908829|141642569|SUPERIORITY||LS Means|-0.26|STANDARD_ERROR_OF_MEAN|0.1|=|0.008|TWO_SIDED|95.0|-0.46|-0.07||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group \& geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.07|-0.46|=0.008
71067155|NCT01908829|141642569|SUPERIORITY||LS Means|-0.34|STANDARD_ERROR_OF_MEAN|0.11|=|0.002|TWO_SIDED|95.0|-0.55|-0.13||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group \& geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.13|-0.55|=0.002
71067156|NCT01908829|141642569|SUPERIORITY||LS Means|-0.28|STANDARD_ERROR_OF_MEAN|0.1|=|0.006|TWO_SIDED|95.0|-0.47|-0.08||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group \& geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.08|-0.47|=0.006
71067157|NCT01908829|141642569|SUPERIORITY||LS Means|-0.31|STANDARD_ERROR_OF_MEAN|0.1|=|0.002|TWO_SIDED|95.0|-0.51|-0.12||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group \& geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.12|-0.51|=0.002
71067158|NCT01908829|141642570|SUPERIORITY||Rate Ratio|0.97|STANDARD_ERROR_OF_MEAN|0.06|=|0.545|TWO_SIDED|95.0|0.87|1.08||p\<0.05 indicates superiority in favor of treatment group with lowest rate of pads used.|Mixed Effects Poisson|||Week 4 rate ratio, 95% CIs, and p-value for number of pads used during the 3-day diary between combination \& solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of pads used/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||1.08|0.87|=0.545
70938602|NCT04454125|141377622|SUPERIORITY||Mean Difference (Net)|-0.31||||0.7|TWO_SIDED|95.0|-1.87|1.25|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome=Childhood Asthma Control Test Score. Obtained at all visits.||1.25|-1.87|0.70
71067159|NCT01908829|141642570|SUPERIORITY||Rate Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.08|=|0.01|TWO_SIDED|95.0|0.7|0.95||p\<0.05 indicates superiority in favor of treatment group with lowest rate of pads used.|Mixed Effects Poisson|||Week 8 rate ratio, 95% CIs, and p-value for number of pads used during the 3-day diary between combination \& solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of pads used/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||0.95|0.70|=0.010
71067160|NCT01908829|141642570|SUPERIORITY||Rate Ratio|0.79|STANDARD_ERROR_OF_MEAN|0.09|=|0.007|TWO_SIDED|95.0|0.67|0.94||p\<0.05 indicates superiority in favor of treatment group with lowest rate of pads used.|Mixed Effects Poisson|||Week 12 rate ratio, 95% CIs, and p-value for number of pads used during the 3-day diary between combination \& solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of pads used/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||0.94|0.67|=0.007
71067161|NCT01908829|141642570|SUPERIORITY||Rate Ratio|0.78|STANDARD_ERROR_OF_MEAN|0.08|=|0.003|TWO_SIDED|95.0|0.66|0.92||p\<0.05 indicates superiority in favor of treatment group with lowest rate of pads used.|Mixed Effects Poisson|||EoT rate ratio, 95% CIs, and p-value for number of pads used during the 3-day diary between combination \& solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of pads used/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||0.92|0.66|=0.003
71067162|NCT01908829|141642571|SUPERIORITY||LS Means|-0.01|STANDARD_ERROR_OF_MEAN|0.05|=|0.836|TWO_SIDED|95.0|-0.1|0.08||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.08|-0.10|=0.836
71067163|NCT01908829|141642571|SUPERIORITY||LS Means|-0.02|STANDARD_ERROR_OF_MEAN|0.05|=|0.617|TWO_SIDED|95.0|-0.12|0.07||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.07|-0.12|=0.617
71067164|NCT01908829|141642571|SUPERIORITY||LS Means|-0.07|STANDARD_ERROR_OF_MEAN|0.05|=|0.134|TWO_SIDED|95.0|-0.17|0.02||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.02|-0.17|=0.134
71067165|NCT01908829|141642571|SUPERIORITY||LS Means|-0.06|STANDARD_ERROR_OF_MEAN|0.05|=|0.174|TWO_SIDED|95.0|-0.16|0.03||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||EOT adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.03|-0.16|=0.174
71078862|NCT01964716|141665744|SUPERIORITY_OR_OTHER||percent difference|0.0|||||TWO_SIDED|95.0|-2.3|2.3||||||Serotype 7F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.3|-2.3|
71112077|NCT02482298|141730982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0975|STANDARD_ERROR_OF_MEAN|0.04923|||TWO_SIDED|90.0|0.0155|0.1795|||Mixed Models Analysis|||||0.1795|0.0155|
71078863|NCT01964716|141665744|SUPERIORITY_OR_OTHER||percent difference|4.7|||||TWO_SIDED|95.0|-4.5|14.1||||||Serotype 9V: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||14.1|-4.5|
71078864|NCT01964716|141665744|SUPERIORITY_OR_OTHER||percent difference|-7.8|||||TWO_SIDED|95.0|-15.8|0.0||||||Serotype 14: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||-0.0|-15.8|
71078865|NCT01964716|141665744|SUPERIORITY_OR_OTHER||percent difference|0.0|||||TWO_SIDED|95.0|-2.9|2.9||||||Serotype 18C: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.9|-2.9|
71078866|NCT01964716|141665744|SUPERIORITY_OR_OTHER||percent difference|-1.9|||||TWO_SIDED|95.0|-6.6|2.4||||||Serotype 19A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.4|-6.6|
71078867|NCT01964716|141665744|SUPERIORITY_OR_OTHER||percent difference|-0.7|||||TWO_SIDED|95.0|-6.3|4.9||||||Serotype 19F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||4.9|-6.3|
71067166|NCT01908829|141642572|SUPERIORITY||Rate Ratio|1.0|STANDARD_ERROR_OF_MEAN|0.04|=|0.993|TWO_SIDED|95.0|0.93|1.08||p\<0.05 indicates superiority in favor of treatment group with lowest rate of nocturia episodes.|Mixed Effects Poisson|||Week 4 rate ratio, 95% CIs, \& p-value for number of nocturia episodes during 3-day diary between combination \& solifenacin treatment calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week incontinence episode reduction group as factors, log of (number of nocturia episodes/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||1.08|0.93|=0.993
71067167|NCT01908829|141642572|SUPERIORITY||Rate Ratio|0.99|STANDARD_ERROR_OF_MEAN|0.04|=|0.736|TWO_SIDED|95.0|0.9|1.07||p\<0.05 indicates superiority in favor of treatment group with lowest rate of nocturia episodes.|Mixed Effects Poisson|||Week 8 rate ratio, 95% CIs, \& p-value for number of nocturia episodes during 3-day diary between combination \& solifenacin treatment calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week incontinence episode reduction group as factors, log of (number of nocturia episodes/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||1.07|0.90|=0.736
71067168|NCT01908829|141642572|SUPERIORITY||Rate Ratio|0.93|STANDARD_ERROR_OF_MEAN|0.05|=|0.121|TWO_SIDED|95.0|0.85|1.02||p\<0.05 indicates superiority in favor of treatment group with lowest rate of nocturia episodes.|Mixed Effects Poisson|||Week 12 rate ratio, 95% CIs, \& p-value for number of nocturia episodes during 3-day diary between combination \& solifenacin treatment calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week incontinence episode reduction group as factors, log of (number of nocturia episodes/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||1.02|0.85|=0.121
71067169|NCT01908829|141642572|SUPERIORITY||Rate Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.04|=|0.172|TWO_SIDED|95.0|0.86|1.03||p\<0.05 indicates superiority in favor of treatment group with lowest rate of nocturia episodes.|Mixed Effects Poisson|||EoT rate ratio, 95% CIs, \& p-value for number of nocturia episodes during 3-day diary between combination \& solifenacin treatment calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week incontinence episode reduction group as factors, log of (number of nocturia episodes/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||1.03|0.86|=0.172
71067170|NCT01908829|141642578|SUPERIORITY||LS Means|-2.89|STANDARD_ERROR_OF_MEAN|0.91|=|0.002|TWO_SIDED|95.0|-4.68|-1.1||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-1.10|-4.68|=0.002
71078868|NCT01964716|141665744|SUPERIORITY_OR_OTHER||percent difference|-1.3|||||TWO_SIDED|95.0|-5.8|3.0||||||Serotype 23F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||3.0|-5.8|
71078869|NCT01964716|141665745|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.7|1.2||||||Serotype 1: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.20|0.70|
71078870|NCT01964716|141665745|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.69|0.93||||||Serotype 3: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||0.93|0.69|
71078871|NCT01964716|141665745|SUPERIORITY_OR_OTHER||GMT Ratio|1.1|||||TWO_SIDED|95.0|0.89|1.39||||||Serotype 4: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.39|0.89|
71078872|NCT01964716|141665745|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.8|1.22||||||Serotype 5: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.22|0.80|
71078873|NCT01964716|141665745|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.7|1.06||||||Serotype 6A: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.06|0.70|
71078874|NCT01964716|141665745|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.74|1.33||||||Serotype 6B: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.33|0.74|
71078875|NCT01964716|141665745|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.7|1.0||||||Serotype 7F: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.00|0.70|
71078876|NCT01964716|141665745|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.79|1.27||||||Serotype 9V: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.27|0.79|
71067171|NCT01908829|141642578|SUPERIORITY||LS Means|-4.5|STANDARD_ERROR_OF_MEAN|0.97|<|0.001|TWO_SIDED|95.0|-6.4|-2.6||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-2.60|-6.40|<0.001
71067172|NCT01908829|141642578|SUPERIORITY||LS Means|-5.59|STANDARD_ERROR_OF_MEAN|1.0|<|0.001|TWO_SIDED|95.0|-7.56|-3.62||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-3.62|-7.56|<0.001
71067173|NCT01908829|141642578|SUPERIORITY||LS Means|-4.96|STANDARD_ERROR_OF_MEAN|0.98|<|0.001|TWO_SIDED|95.0|-6.88|-3.04||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-3.04|-6.88|<0.001
71067174|NCT01908829|141642579|SUPERIORITY||LS Means|1.92|STANDARD_ERROR_OF_MEAN|0.83|=|0.021|TWO_SIDED|95.0|0.29|3.55||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||3.55|0.29|=0.021
71067175|NCT01908829|141642579|SUPERIORITY||LS Means|2.31|STANDARD_ERROR_OF_MEAN|0.89|=|0.01|TWO_SIDED|95.0|0.56|4.06||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.06|0.56|=0.010
71067176|NCT01908829|141642579|SUPERIORITY||LS Means|3.49|STANDARD_ERROR_OF_MEAN|0.94|<|0.001|TWO_SIDED|95.0|1.65|5.33||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||5.33|1.65|<0.001
71067177|NCT01908829|141642579|SUPERIORITY||LS Means|3.15|STANDARD_ERROR_OF_MEAN|0.92|=|0.001|TWO_SIDED|95.0|1.35|4.95||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.95|1.35|=0.001
71067178|NCT01908829|141642580|SUPERIORITY||LS Means|2.9|STANDARD_ERROR_OF_MEAN|0.96|=|0.003|TWO_SIDED|95.0|1.02|4.78||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.78|1.02|=0.003
71067179|NCT01908829|141642580|SUPERIORITY||LS Means|3.35|STANDARD_ERROR_OF_MEAN|1.05|=|0.001|TWO_SIDED|95.0|1.29|5.4||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||5.40|1.29|=0.001
71112078|NCT03782259|141731011|SUPERIORITY||||||<|0.0125||||||Given that there were 4 separate comparisons of the primary outcomes, the level of significance was adjusted from 0.05 to 0.0125 (.05/4) using the Bonferroni correction.|Wilcoxon (Mann-Whitney)|There were no adjustments for covariates.||||||< 0 .0125
71112079|NCT03782259|141731012|SUPERIORITY||||||<|0.0125||||||Given that there were 4 separate comparisons of the primary outcomes, the level of significance was adjusted from 0.05 to 0.0125 (.05/4) using the Bonferroni correction.|Wilcoxon (Mann-Whitney)|There were no adjustments for covariates.||||||< 0 .0125
71112080|NCT05507567|141731024|OTHER|||||||0.0331|||||||Chi-squared|||A priori primary analysis group||||0.0331
71112081|NCT05507567|141731025|OTHER|||||||0.1427||||||Hodges-Lehmann (H-L) estimation|Wilcoxon (Mann-Whitney)|1-sided Wilcoxon rank-sum||||||0.1427
71112082|NCT05507567|141731026|OTHER|||||||0.1307||||||H-L estimation|Wilcoxon (Mann-Whitney)|1-sided Wilcoxon rank-sum||||||0.1307
70852734|NCT01578850|141194338|SUPERIORITY_OR_OTHER||Difference in Proportions|-2.7||||0.702|TWO_SIDED|95.0|-13.49|8.11|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 70: Week 24||8.11|-13.49|0.702
70938603|NCT04454125|141377622|SUPERIORITY||Mean Difference (Net)|3.96||||0.14|TWO_SIDED|95.0|-1.27|9.2|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome=Childhood Asthma Control Test Score. Obtained at all visits.||9.20|-1.27|0.14
70938604|NCT04454125|141377622|SUPERIORITY||Mean Difference (Net)|4.27||||0.13|TWO_SIDED|95.0|-1.19|9.73|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome=Childhood Asthma Control Test Scores.||9.73|-1.19|0.13
71067180|NCT01908829|141642580|SUPERIORITY||LS Means|4.71|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|2.55|6.87||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||6.87|2.55|<0.001
71067181|NCT01908829|141642580|SUPERIORITY||LS Means|4.29|STANDARD_ERROR_OF_MEAN|1.07|<|0.001|TWO_SIDED|95.0|2.2|6.39||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||6.39|2.20|<0.001
71067182|NCT01908829|141642581|SUPERIORITY||LS Means|1.94|STANDARD_ERROR_OF_MEAN|0.96|=|0.044|TWO_SIDED|95.0|0.05|3.83||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||3.83|0.05|=0.044
71067183|NCT01908829|141642581|SUPERIORITY||LS Means|2.5|STANDARD_ERROR_OF_MEAN|1.0|=|0.012|TWO_SIDED|95.0|0.55|4.46||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.46|0.55|=0.012
71067184|NCT01908829|141642581|SUPERIORITY||LS Means|3.61|STANDARD_ERROR_OF_MEAN|1.05|=|0.001|TWO_SIDED|95.0|1.54|5.67||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||5.67|1.54|=0.001
71067185|NCT01908829|141642581|SUPERIORITY||LS Means|3.28|STANDARD_ERROR_OF_MEAN|1.03|=|0.001|TWO_SIDED|95.0|1.27|5.29||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||5.29|1.27|=0.001
71067186|NCT01908829|141642582|SUPERIORITY||LS Means|0.54|STANDARD_ERROR_OF_MEAN|0.96|=|0.575|TWO_SIDED|95.0|-1.35|2.43||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||2.43|-1.35|=0.575
71067187|NCT01908829|141642582|SUPERIORITY||LS Means|1.61|STANDARD_ERROR_OF_MEAN|1.0|=|0.109|TWO_SIDED|95.0|-0.36|3.58||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||3.58|-0.36|=0.109
71078877|NCT01964716|141665745|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.48|1.08||||||Serotype 14: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.08|0.48|
70941792|NCT04748445|141383937|OTHER||Slope|-3.262|STANDARD_ERROR_OF_MEAN|4.487||0.9421|TWO_SIDED|90.0|-7.761|7.109|||Mixed Models Analysis|||EE\_Formant 1 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-1. For estimated value it was 10\^-2).||7.109|-7.761|0.9421
71067188|NCT01908829|141642582|SUPERIORITY||LS Means|2.26|STANDARD_ERROR_OF_MEAN|1.05|=|0.032|TWO_SIDED|95.0|0.2|4.32||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.32|0.20|=0.032
71067189|NCT01908829|141642582|SUPERIORITY||LS Means|1.86|STANDARD_ERROR_OF_MEAN|1.02|=|0.069|TWO_SIDED|95.0|-0.15|3.87||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||3.87|-0.15|=0.069
71067190|NCT01908829|141642583|SUPERIORITY||LS Means|1.73|STANDARD_ERROR_OF_MEAN|0.83|=|0.037|TWO_SIDED|95.0|0.1|3.36||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||3.36|0.10|=0.037
71067191|NCT01908829|141642583|SUPERIORITY||LS Means|1.09|STANDARD_ERROR_OF_MEAN|0.85|=|0.199|TWO_SIDED|95.0|-0.57|2.76||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||2.76|-0.57|=0.199
71067192|NCT01908829|141642583|SUPERIORITY||LS Means|2.62|STANDARD_ERROR_OF_MEAN|0.87|=|0.003|TWO_SIDED|95.0|0.92|4.31||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.31|0.92|=0.003
71067193|NCT01908829|141642583|SUPERIORITY||LS Means|2.48|STANDARD_ERROR_OF_MEAN|0.85|=|0.004|TWO_SIDED|95.0|0.81|4.15||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.15|0.81|=0.004
71067194|NCT01908829|141642584|SUPERIORITY||LS Means|0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|0.2|0.6||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as the 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.6|0.2|<0.001
71067195|NCT01908829|141642584|SUPERIORITY||LS Means|0.3|STANDARD_ERROR_OF_MEAN|0.1|=|0.019|TWO_SIDED|95.0|0.0|0.5||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as the 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.5|0.0|=0.019
71078878|NCT01964716|141665745|SUPERIORITY_OR_OTHER||GMT Ratio|1.7|||||TWO_SIDED|95.0|1.38|2.19||||||Serotype 18C: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||2.19|1.38|
71078879|NCT01964716|141665745|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.74|1.16||||||Serotype 19A: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.16|0.74|
71078880|NCT01964716|141665745|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.71|1.18||||||Serotype 19F: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.18|0.71|
70941793|NCT04748445|141383937|OTHER||Slope|-0.06912|STANDARD_ERROR_OF_MEAN|5.997||0.9084|TWO_SIDED|90.0|-1.063|0.9247|||Mixed Models Analysis|||EE\_Formant 1 Bandwidth (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||0.9247|-1.063|0.9084
71067196|NCT01908829|141642584|SUPERIORITY||LS Means|0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|0.3|0.7||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as the 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.7|0.3|<0.001
71067197|NCT01908829|141642584|SUPERIORITY||LS Means|0.4|STANDARD_ERROR_OF_MEAN|0.1|=|0.001|TWO_SIDED|95.0|0.2|0.6||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as the 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.6|0.2|=0.001
71067198|NCT01908829|141642585|SUPERIORITY||LS Means|-0.2|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.4|-0.1||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as the 95% CIs and p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Difference of adjusted mean was calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.1|-0.4|<0.001
71067199|NCT01908829|141642585|SUPERIORITY||LS Means|-0.2|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.4|-0.1||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as the 95% CIs and p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Difference of adjusted mean was calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.1|-0.4|<0.001
71067200|NCT01908829|141642585|SUPERIORITY||LS Means|-0.3|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.4|-0.2||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as the 95% CIs and p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Difference of adjusted mean was calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.2|-0.4|<0.001
71067201|NCT01908829|141642585|SUPERIORITY||LS Means|-0.3|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.4|-0.1||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as the 95% CIs and p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Difference of adjusted mean was calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.1|-0.4|<0.001
71067202|NCT01908829|141642587|SUPERIORITY||Odds Ratio (OR)|1.48|||<|0.001|TWO_SIDED|95.0|1.19|1.84||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.84|1.19|<0.001
71067203|NCT01908829|141642587|SUPERIORITY||Odds Ratio (OR)|1.57|||<|0.001|TWO_SIDED|95.0|1.25|1.98||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.98|1.25|<0.001
71067204|NCT01908829|141642587|SUPERIORITY||Odds Ratio (OR)|1.54|||=|0.001|TWO_SIDED|95.0|1.21|1.95||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.95|1.21|=0.001
71067205|NCT01908829|141642587|SUPERIORITY||Odds Ratio (OR)|1.51|||<|0.001|TWO_SIDED|95.0|1.2|1.9||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.90|1.20|<0.001
71112083|NCT05507567|141731027|OTHER|||||||0.0382||||||H-L estimation|Wilcoxon (Mann-Whitney)|1-sided Wilcoxon rank-sum||||||0.0382
71112084|NCT05507567|141731028|OTHER|||||||0.011||||||H-L estimation|Wilcoxon (Mann-Whitney)|1-sided Wilcoxon rank-sum||||||0.0110
71112085|NCT03024112|141731042|OTHER|||||||0.68|||||||t-test, 1 sided|||||||0.680
71112086|NCT03703232|141731046|SUPERIORITY|||||||0.092|||||||Wilcoxon signed-rank test|||||||0.092
71112087|NCT03703232|141731047|SUPERIORITY|||||||0.76|||||||Wilcoxon signed-rank test|||||||0.760
71112088|NCT03703232|141731048|SUPERIORITY|||||||0.007|||||||Wilcoxon signed-rank test|||||||0.007
71112089|NCT03703232|141731049|SUPERIORITY|||||||0.003|||||||Wilcoxon signed-rank test|||||||0.003
71112090|NCT03703232|141731050|SUPERIORITY|||||||0.861|||||||Wilcoxon signed-rank test|||||||0.861
70938605|NCT04454125|141377623|SUPERIORITY||Mean Difference (Net)|0.25||||0.11|TWO_SIDED|95.0|-0.06|0.55|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Pediatric Asthma Quality of Life Questionnaire. Obtained at randomization and exit visits (visit 1 and visit 7).||0.55|-0.06|0.11
70938606|NCT04454125|141377623|SUPERIORITY||Mean Difference (Net)|0.54||||0.002|TWO_SIDED|95.0|0.2|0.88|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Pediatric Asthma Quality of Life Questionnaire. Obtained at randomization and exit visits (visit 1 and visit 7).||0.88|0.20|0.002
70938607|NCT04454125|141377623|SUPERIORITY||Mean Difference (Net)|0.3||||0.2|TWO_SIDED|95.0|-0.16|0.75|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Pediatric Asthma Quality of Life Questionnaire. Obtained at randomization and exit visits (visit 1 and visit 7).||0.75|-0.16|0.20
70938608|NCT04454125|141377624|SUPERIORITY||Odds Ratio (OR)|0.94||||0.87|TWO_SIDED|95.0|0.45|1.96|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Reported checking the AQI prior to going outside to be active||1.96|0.45|0.87
71067206|NCT01908829|141642588|SUPERIORITY||Odds Ratio (OR)|1.24|||=|0.119|TWO_SIDED|95.0|0.95|1.63||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.63|0.95|=0.119
71112091|NCT03703232|141731052|SUPERIORITY|||||||0.405|||||||Wilcoxon signed-rank test|||||||0.405
71112092|NCT03703232|141731053|SUPERIORITY|||||||0.798|||||||Wilcoxon signed-rank test|||||||0.798
70938609|NCT04454125|141377624|SUPERIORITY||Odds Ratio (OR)|6.89||||0.004|TWO_SIDED|95.0|1.85|25.6|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Reported checking the AQI prior to going outside to be active||25.6|1.85|0.004
70938610|NCT04454125|141377624|SUPERIORITY||Odds Ratio (OR)|7.31||||0.01|TWO_SIDED|95.0|1.62|32.9|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Reported checking the AQI prior to going outside to be active||32.9|1.62|0.01
70938611|NCT04454125|141377625|SUPERIORITY||Odds Ratio (OR)|0.34||||0.15|TWO_SIDED|95.0|0.08|1.47|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Reported outdoor activity behavioral change in response to the AQI, obtained at all visits.||1.47|0.08|0.15
70938612|NCT04454125|141377625|SUPERIORITY||Odds Ratio (OR)|0.96||||0.94|TWO_SIDED|95.0|0.35|2.68|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Reported outdoor activity behavioral change in response to the AQI, obtained at all visits.||2.68|0.35|0.94
71067207|NCT01908829|141642588|SUPERIORITY||Odds Ratio (OR)|1.56|||<|0.001|TWO_SIDED|95.0|1.23|1.98||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.98|1.23|<0.001
71112093|NCT03703232|141731054|SUPERIORITY|||||||0.382|||||||Wilcoxon signed-rank test|||||||0.382
71112094|NCT03703232|141731055|SUPERIORITY|||||||0.179|||||||Wilcoxon signed-rank test|||||||0.179
71112095|NCT03703232|141731056|SUPERIORITY|||||||0.984|||||||Wilcoxon signed-rank test|||||||0.984
71112096|NCT01771991|141731058|SUPERIORITY||sum of scores|453.0|STANDARD_DEVIATION|39.6||0.57|TWO_SIDED||||||Wilcoxon Rank-Sum||Standard Deviation under the Null hypothesis for each group.|||||0.57
71112097|NCT01771991|141731059|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_DEVIATION|1.5||0.65|TWO_SIDED|95.0|-0.6|0.95|||t-test, 2 sided|||Looking at the difference in pain change over time. The null hypothesis is there was no difference between the two treatment groups.||0.95|-0.60|0.65
71112098|NCT01771991|141731060|SUPERIORITY||Mean Difference (Final Values)|2.63|STANDARD_DEVIATION|17.79||0.57|TWO_SIDED|95.0|-6.65|11.91|||t-test, 2 sided|||Looking at the difference in range of motion change over time. The null hypothesis is there was no difference between the two treatment groups.||11.91|-6.65|0.57
71112099|NCT01399229|141731061|NON_INFERIORITY_OR_EQUIVALENCE|"Agreement between SureCALL® and Tocodynamometer Contraction Peak Times~Null hypothesis: The mean peak difference between RMS and TOCO is equal to 0. Alternative hypothesis: The mean peak difference is not equal to 0."|Mean Difference (Net)|0.99|STANDARD_ERROR_OF_MEAN|1.4086||0.4901|TWO_SIDED|95.0|-28.74|30.72|||Mixed Models Analysis|||||30.72|-28.74|0.4901
71112100|NCT03726658|141731070|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose). Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.|Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|2.24||0.98|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05.|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose). Since this was a phase 1 study no power calculation was performed.||||0.98
71067208|NCT01908829|141642588|SUPERIORITY||Odds Ratio (OR)|1.44|||=|0.002|TWO_SIDED|95.0|1.14|1.82||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.82|1.14|=0.002
71112101|NCT03726658|141731070|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose). Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.|Median Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|2.25||0.25|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05.|Mixed Models Analysis|Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose).||Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose). Since this was a phase 1 study no power calculation was performed.||||0.25
71067209|NCT01908829|141642588|SUPERIORITY||Odds Ratio (OR)|1.47|||=|0.001|TWO_SIDED|95.0|1.17|1.84||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.84|1.17|=0.001
71067210|NCT01908829|141642589|SUPERIORITY||Odds Ratio (OR)|1.15|||=|0.305|TWO_SIDED|95.0|0.88|1.5||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.50|0.88|=0.305
71067211|NCT01908829|141642589|SUPERIORITY||Odds Ratio (OR)|1.37|||=|0.014|TWO_SIDED|95.0|1.06|1.76||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.76|1.06|=0.014
71067212|NCT01908829|141642589|SUPERIORITY||Odds Ratio (OR)|1.37|||=|0.012|TWO_SIDED|95.0|1.07|1.76||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.76|1.07|=0.012
71067213|NCT01908829|141642589|SUPERIORITY||Odds Ratio (OR)|1.29|||=|0.036|TWO_SIDED|95.0|1.02|1.64||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.64|1.02|=0.036
71067214|NCT01908829|141642590|SUPERIORITY||Odds Ratio (OR)|1.49|||=|0.001|TWO_SIDED|95.0|1.18|1.88||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.88|1.18|=0.001
71112102|NCT03726658|141731070|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose).|Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|2.26||0.93|TWO_SIDED|||||Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose).|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose).||||0.93
71067215|NCT01908829|141642590|SUPERIORITY||Odds Ratio (OR)|1.69|||<|0.001|TWO_SIDED|95.0|1.31|2.18||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||2.18|1.31|<0.001
71067216|NCT01908829|141642590|SUPERIORITY||Odds Ratio (OR)|1.96|||<|0.001|TWO_SIDED|95.0|1.47|2.61||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||2.61|1.47|<0.001
71067217|NCT01908829|141642590|SUPERIORITY||Odds Ratio (OR)|1.75|||<|0.001|TWO_SIDED|95.0|1.34|2.3||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||2.30|1.34|<0.001
71067218|NCT01908829|141642591|SUPERIORITY||Odds Ratio (OR)|1.44|||=|0.003|TWO_SIDED|95.0|1.14|1.82||p\<0.05 indicates superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.82|1.14|=0.003
71067219|NCT01908829|141642591|SUPERIORITY||Odds Ratio (OR)|1.51|||=|0.001|TWO_SIDED|95.0|1.18|1.93||p\<0.05 indicates superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.93|1.18|=0.001
71067220|NCT01908829|141642591|SUPERIORITY||Odds Ratio (OR)|1.64|||<|0.001|TWO_SIDED|95.0|1.27|2.13||p\<0.05 indicates superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||2.13|1.27|<0.001
71067221|NCT01908829|141642591|SUPERIORITY||Odds Ratio (OR)|1.5|||=|0.001|TWO_SIDED|95.0|1.17|1.91||p\<0.05 indicates superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.91|1.17|=0.001
71067222|NCT01908829|141642592|SUPERIORITY||Odds Ratio (OR)|1.42|||=|0.003|TWO_SIDED|95.0|1.13|1.79||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.79|1.13|=0.003
71067223|NCT01908829|141642592|SUPERIORITY||Odds Ratio (OR)|1.44|||=|0.004|TWO_SIDED|95.0|1.12|1.84||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.84|1.12|=0.004
71067224|NCT01908829|141642592|SUPERIORITY||Odds Ratio (OR)|1.5|||=|0.003|TWO_SIDED|95.0|1.15|1.96||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.96|1.15|=0.003
71067225|NCT01908829|141642592|SUPERIORITY||Odds Ratio (OR)|1.43|||=|0.006|TWO_SIDED|95.0|1.11|1.84||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.84|1.11|=0.006
71067226|NCT01908829|141642593|SUPERIORITY||Odds Ratio (OR)|1.28|||=|0.065|TWO_SIDED|95.0|0.99|1.66|||Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.66|0.99|=0.065
71067227|NCT01908829|141642593|SUPERIORITY||Odds Ratio (OR)|1.41|||=|0.004|TWO_SIDED|95.0|1.11|1.79|||Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.79|1.11|=0.004
71067228|NCT01908829|141642593|SUPERIORITY||Odds Ratio (OR)|1.64|||<|0.001|TWO_SIDED|95.0|1.3|2.07|||Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||2.07|1.30|<0.001
71067229|NCT01908829|141642593|SUPERIORITY||Odds Ratio (OR)|1.55|||<|0.001|TWO_SIDED|95.0|1.24|1.94|||Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.94|1.24|<0.001
71112103|NCT03726658|141731071|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group|Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|2.02||0.43|TWO_SIDED|||||a priori threshold for statistical significance was \<0.05|Mixed Models Analysis|||Chane from baseline in treated group compared to change from baseline in placebo group. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.43
71067230|NCT01339923|141642636|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority.|Vaccine group difference|-1.0|||||TWO_SIDED|95.0|-6.4|3.9|||Miettinen and Nurminen method|||Non-inferiority of MenC-CRM was determined following co-administration of MenC-CRM and rMenB+OMV NZ vs MenC-CRM control group at 1 month after 2nd vaccination for serogroup C.||3.9|-6.4|
71067231|NCT01339923|141642636|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority.|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-5.2|7.6|||Miettinen and Nurminen method|||Non-inferiority of MenC-CRM was determined following co-administration of MenC-CRM and rMenB+OMV NZ vs MenC-CRM control group at 1 month after booster vaccination for serogroup C.||7.6|-5.2|
71067232|NCT01430403|141642652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48|STANDARD_ERROR_OF_MEAN|0.331||0.03|TWO_SIDED|95.0|0.25|0.92|||Odds Ratio|Adjusted for Site, dosing group and treatment step|Placebo serves as the reference group. Values \< 1 represent more exacerbations in the placebo arm.|Null hypothesis is that there is no difference between the arms. Power calculation is described in detail in the study protocol.||0.92|0.25|0.03
71112104|NCT03726658|141731071|EQUIVALENCE|Change from baseline in treated group compared to change in baseline in placebo group|Median Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|2.02||0.84|TWO_SIDED|||||The a priori threshold for statistical significance was P \<0.05|Mixed Models Analysis|||Change from baseline in treated group compared to change in placebo group. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.84
71067233|NCT01430403|141642653|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73|STANDARD_ERROR_OF_MEAN|0.41||0.45|TWO_SIDED|95.0|0.33|1.64|||Odds Ratio|Adjusted for Site, dosing group and treatment step|ICS Boost serves as the reference group. Values \< 1 represent more exacerbations in the ICS arm.|Null hypothesis is that there is no difference between the arms. Power calculation is described in detail in the study protocol.||1.64|0.33|0.45
71067234|NCT01430403|141642654|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.53|||<|0.01|TWO_SIDED|95.0|2.38|5.22|||Chi-squared||Adjusted for site|||5.22|2.38|<0.01
71067235|NCT01430403|141642655|SUPERIORITY_OR_OTHER||Linear Regression|0.004||||0.94|TWO_SIDED|95.0|-0.1|0.11|||F-Test|||||0.11|-0.10|0.94
71067236|NCT01430403|141642655|SUPERIORITY_OR_OTHER||Linear Regression|-0.13||||0.33|TWO_SIDED|95.0|-0.4|0.13|||F-Test|||||0.13|-0.40|0.33
71067237|NCT01430403|141642656|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.552|TWO_SIDED|95.0|0.87|1.31|||Chi-squared|||||1.31|0.87|0.552
71067238|NCT01430403|141642656|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.37|TWO_SIDED|95.0|0.87|1.44|||Chi-squared|||||1.44|0.87|0.37
71067239|NCT01430403|141642657|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.3||0.09|TWO_SIDED|95.0|-1.11|0.07|||Regression, Linear|Adjustments for randomization CASI, site, dosing group and treatment group step (2-4 as one step and 5 separately)||||0.07|-1.11|0.09
71067240|NCT01430403|141642658|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.3||0.39|TWO_SIDED|95.0|-0.86|0.34|||Regression, Linear|Adjustments for randomization CASI, site and dosing group||||0.34|-0.86|0.39
71112105|NCT03726658|141731072|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 9|Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|2.65||0.69|TWO_SIDED|||||A priori threshold for statistical significance was P\<0.05.|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 9. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.69
71112106|NCT03726658|141731072|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 9|Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|2.66||0.44|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 9. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.44
71112107|NCT03726658|141731072|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 9|Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|2.66||0.43|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 9. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.43
71112108|NCT03726658|141731072|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 15|Median Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|2.65||0.55|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05.|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 15. Since this was a phase 1 study no power calculaton was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.55
71112109|NCT03726658|141731072|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 15.|Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|2.66||0.44|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 15. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.44
71067241|NCT01430403|141642659|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|1.58||0.84|TWO_SIDED|95.0|-3.42|2.78|||Regression, Linear|Adjustments for randomization FEV1 % predicted, site, dosing group and treatment group step (2-4 as one step and 5 separately)||||2.78|-3.42|0.84
71067242|NCT01430403|141642660|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.37|STANDARD_ERROR_OF_MEAN|1.59||0.14|TWO_SIDED|95.0|-0.76|5.51|||Regression, Linear|Adjustments for randomization FEV1 % predicted, site and dosing group.||||5.51|-0.76|0.14
71067243|NCT01430403|141642661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25|STANDARD_ERROR_OF_MEAN|0.89||0.78|TWO_SIDED|95.0|-1.49|1.99|||Regression, Linear|Adjustments for randomization FEV1:FVCx100, site, dosing group and treatment group step (2-4 as one step and 5 separately)||||1.99|-1.49|0.78
71067244|NCT01430403|141642662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.15|STANDARD_ERROR_OF_MEAN|0.89||0.2|TWO_SIDED|95.0|-0.61|2.91|||Regression, Linear|Adjustments for randomization FEV1:FVCx100, site and dosing group.||||2.91|-0.61|0.20
71067245|NCT01430403|141642663|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.11|STANDARD_ERROR_OF_MEAN|0.4||0.006|TWO_SIDED|95.0|0.32|1.9|||Regression, Linear|Adjustments for randomization ACT, site, dosing group and treatment group step (2-4 as one step and 5 separately)||||1.90|0.32|0.006
71067246|NCT01430403|141642664|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.41||0.89|TWO_SIDED|95.0|-0.76|0.86|||Regression, Linear|Adjustments for randomization ACT, site and dosing group.||||0.86|-0.76|0.89
71067247|NCT01430403|141642665|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.71|STANDARD_ERROR_OF_MEAN|0.36||0.05|TWO_SIDED|95.0|0.0|1.41|||Regression, Linear|Adjustments for randomization C-ACT, site, dosing group and treatment group step (2-4 as one step and 5 separately)||||1.41|0.00|0.05
71067248|NCT01430403|141642666|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58|STANDARD_ERROR_OF_MEAN|0.37||0.12|TWO_SIDED|95.0|-0.15|1.3|||Regression, Linear|Adjustments for randomization C-ACT, site and dosing group||||1.30|-0.15|0.12
71067249|NCT01430403|141642667|SUPERIORITY_OR_OTHER||Rate Ratio|0.72|STANDARD_ERROR_OF_MEAN|0.68||0.63|TWO_SIDED|95.0|0.19|0.72|||Negative Binomial Generalized Estimating|Adjustments for site, dosing group and treatment group step (2-4 as one step and 5 separately)||||0.72|0.19|0.63
71067250|NCT01430403|141642668|SUPERIORITY_OR_OTHER||Ratio|1.0|STANDARD_ERROR_OF_MEAN|0.63||0.99|TWO_SIDED|95.0|0.29|3.46|||Negative Binomial Generalized Estimating|Adjustments for site and dosing group||||3.46|0.29|0.99
71067251|NCT01430403|141642669|SUPERIORITY_OR_OTHER||Ratio|0.72|STANDARD_ERROR_OF_MEAN|0.32||0.31|TWO_SIDED|95.0|0.39|1.35|||Negative Binomial Generalized Estimating|Adjustments for site, dosing group and treatment group step (2-4 as one step and 5 separately)||||1.35|0.39|0.31
71067252|NCT01430403|141642670|SUPERIORITY_OR_OTHER||Ratio|0.48|STANDARD_ERROR_OF_MEAN|0.39||0.06|TWO_SIDED|95.0|0.23|1.02|||Negative Binomial Generalized Estimating|Adjustments for site and dosing group||||1.02|0.23|0.06
71067253|NCT01430403|141642671|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|1.48||0.9|TWO_SIDED|95.0|-3.08|2.72|||Regression, Linear|Adjustments for site, dosing group and treatment group step (2-4 as one step and 5 separately)||||2.72|-3.08|0.90
71067254|NCT01430403|141642672|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|1.52||0.86|TWO_SIDED|95.0|-3.26|2.71|||Regression, Linear|Adjustments for site and dosing group.||||2.71|-3.26|0.86
71067255|NCT00403481|141642674|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|One-sample t-test|||||||<0.0001
71067256|NCT00403481|141642675|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||\<0.0001 for both daytime and nighttime. No multiplicity adjustments.|one-sample t-test|||||||<0.0001
71067257|NCT00403481|141642676|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||One-sample t-test|||||||<0.0001
71067258|NCT00403481|141642677|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||No multiplicity adjustments|one-sample t-test|||||||0.0001
71067259|NCT00403481|141642679|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||one-sample t-test|||||||<0.0001
71067260|NCT00403481|141642680|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||\<0.0001 applies to both the daytime and nighttime analyses|one-sample t-test|||||||<0.0001
71112110|NCT03726658|141731072|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 15|Median Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|2.69||0.56|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 15. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.56
71067261|NCT00403481|141642681|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||one-sample t-test|||||||<0.0001
71067262|NCT00403481|141642682|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||\<0.0001 applies to both 4 hour and 6 hour analyses|one-sample t-test|||||||<0.0001
71067263|NCT02099110|141642691|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.46|||<|0.001|TWO_SIDED|95.0|-0.63|-0.3||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.30|-0.63|<0.001
71067264|NCT02099110|141642691|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.43|||<|0.001|TWO_SIDED|95.0|-0.6|-0.27||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.27|-0.60|<0.001
71067265|NCT02099110|141642691|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.44|||<|0.001|TWO_SIDED|95.0|-0.61|-0.27||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.27|-0.61|<0.001
71112111|NCT03726658|141731072|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 22.|Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|2.74||0.8|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05.|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 22. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.80
71067266|NCT02099110|141642691|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.47|||<|0.001|TWO_SIDED|95.0|-0.63|-0.3||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.30|-0.63|<0.001
71112112|NCT03726658|141731072|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 22.|Median Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|2.74||0.45|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 22. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.45
71112113|NCT03726658|141731072|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 22.|Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|2.77||0.67|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 22. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.67
71067267|NCT02099110|141642692|SUPERIORITY_OR_OTHER||Difference in % vs Ertugliflozin 5 mg|-3.2|||||TWO_SIDED|95.0|-11.7|5.5|||||Based on Miettinen \& Nurminen method.|||5.5|-11.7|
71067268|NCT02099110|141642692|SUPERIORITY_OR_OTHER||Difference in % vs. Ertugliflozin 15 mg|-1.9|||||TWO_SIDED|95.0|-10.6|6.8|||||Based on Miettinen \& Nurminen method.|||6.8|-10.6|
71067269|NCT02099110|141642692|SUPERIORITY_OR_OTHER||Difference in % vs. Sitagliptin 100 mg|1.4|||||TWO_SIDED|95.0|-7.4|10.1|||||Based on Miettinen \& Nurminen method.|||10.1|-7.4|
71067270|NCT02099110|141642692|SUPERIORITY_OR_OTHER||Difference in % vs. Sitagliptin 100 mg|-1.8|||||TWO_SIDED|95.0|-10.5|7.0|||||Based on Miettinen \& Nurminen method.|||7.0|-10.5|
71067271|NCT02099110|141642693|SUPERIORITY_OR_OTHER||Difference in % vs. Ertugliflozin 5 mg|0.1|||||TWO_SIDED|95.0|-3.3|3.6|||||Based on Miettinen \& Nurminen method.|||3.6|-3.3|
71067272|NCT02099110|141642693|SUPERIORITY_OR_OTHER||Difference in % vs. Ertugliflozin 15 mg|0.5|||||TWO_SIDED|95.0|-3.0|4.0|||||Based on Miettinen \& Nurminen method.|||4.0|-3.0|
71067273|NCT02099110|141642693|SUPERIORITY_OR_OTHER||Difference in % vs. Sitagliptin 100 mg|0.5|||||TWO_SIDED|95.0|-2.9|3.9|||||Based on Miettinen \& Nurminen method.|||3.9|-2.9|
71067274|NCT02099110|141642693|SUPERIORITY_OR_OTHER||Difference in % vs. Sitagliptin 100 mg|0.9|||||TWO_SIDED|95.0|-2.5|4.4|||||Based on Miettinen \& Nurminen method.|||4.4|-2.5|
71067275|NCT02099110|141642694|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.85|||<|0.001|TWO_SIDED|95.0|-2.48|-1.22||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-1.22|-2.48|<0.001
70938613|NCT04454125|141377625|SUPERIORITY||Odds Ratio (OR)|2.79||||0.26|TWO_SIDED|95.0|0.47|16.5|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Reported outdoor activity behavioral change in response to the AQI, obtained at all visits.||16.5|0.47|0.26
70938614|NCT04454125|141377626|SUPERIORITY||Odds Ratio (OR)|0.42||||0.004|TWO_SIDED|95.0|0.24|0.76|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Obtained at all visits||0.76|0.24|0.004
70938615|NCT04454125|141377626|SUPERIORITY||Odds Ratio (OR)|0.13|||<|0.0001|TWO_SIDED|95.0|0.05|0.31|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Obtained at all visits.||0.31|0.05|<0.0001
71067276|NCT02099110|141642694|SUPERIORITY_OR_OTHER||Difference in the least squares means|-2.27|||<|0.001|TWO_SIDED|95.0|-2.9|-1.64||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained logitudinal data analysis|||||-1.64|-2.90|<0.001
71067277|NCT02099110|141642695|SUPERIORITY_OR_OTHER||Difference in the least squares means|-8.23||||0.004|TWO_SIDED|95.0|-13.82|-2.65||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA|||||-2.65|-13.82|0.004
71112114|NCT03726658|141731073|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 11|Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|2.36||0.43|TWO_SIDED|||||a priori threshold for statistical significance was p\>0.05|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 11. Since this was a phase 1 study, no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.43
71112115|NCT03726658|141731073|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 11|Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|2.38||0.59|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 11. Since this was a phase 1 study, no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.59
70938616|NCT04454125|141377626|SUPERIORITY||Odds Ratio (OR)|0.29||||0.03|TWO_SIDED|95.0|0.1|0.87|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Obtained at all visits.||0.87|0.10|0.03
70938617|NCT01799993|141377707|SUPERIORITY||Odds Ratio (OR)|0.841||||0.4263|TWO_SIDED|95.0|0.554|1.277|||Cochran-Mantel-Haenszel|||||1.277|0.554|0.4263
70938618|NCT01799993|141377708|SUPERIORITY|||||||0.6421|||||||Chi-squared|||||||0.6421
71112116|NCT03726658|141731073|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 14|Mean Difference (Final Values)|-2.3|STANDARD_ERROR_OF_MEAN|2.44||0.35|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 14, Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.35
70938619|NCT01799993|141377709|SUPERIORITY|||||||0.7984|||||||Chi-squared|||||||0.7984
70938620|NCT01799993|141377710|SUPERIORITY|||||||0.7144|||||||ANOVA|||||||0.7144
70938621|NCT01799993|141377711|SUPERIORITY|||||||0.4278|||||||ANOVA|||||||0.4278
70938622|NCT00759681|141377733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.208|STANDARD_ERROR_OF_MEAN|0.0538||0.05|TWO_SIDED|95.0|0.103|0.314|||Exact binomial confidence limit|Effectiveness: 95% confidence limits of the difference between groups, and ensuring that the lower limit of the difference was greater than 10%.||Effectiveness was evaluated using a superiority hypothesis, comparing treatment sites with regards to the proportion achieving immediate suture line sealing between the groups. Effectiveness was based on a two-tailed, 0.05 hypothesis test, with a minimum effect size set at 10%. The mean difference in the proportion of sites achieving immediate suture line sealing was compared between the Control and Investigation Device groups.||0.314|0.103|0.05
71067278|NCT02099110|141642695|SUPERIORITY_OR_OTHER||Difference in the least squares means|-11.79|||<|0.001|TWO_SIDED|95.0|-17.35|-6.23||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA|||||-6.23|-17.35|<0.001
71067279|NCT02099110|141642695|SUPERIORITY_OR_OTHER||Difference in the least squares means|-18.4|||<|0.001|TWO_SIDED|95.0|-24.03|-12.77||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA|||||-12.77|-24.03|<0.001
71067280|NCT02099110|141642695|SUPERIORITY_OR_OTHER||Difference in the least squares means|-23.14|||<|0.001|TWO_SIDED|95.0|-28.76|-17.53||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA|||||-17.53|-28.76|<0.001
70938623|NCT00759681|141377734|NON_INFERIORITY_OR_EQUIVALENCE|Safety was evaluated using non-inferiority hypothesis evaluating the proportion of cases with any instance of sign. bleeding, neurological deficit or immune/inflammatory allergic response. Safety based on one-tailed, 0.05 alpha, with equivalence limit set at 15%.|Mean Difference (Final Values)|-0.135|STANDARD_ERROR_OF_MEAN|0.0671||0.05|ONE_SIDED|95.0||-0.003|||Exact binomial confidence limit|Safety: 95% confidence limits of the difference between groups, and ensuring that the upper limit of the difference was less than or equal to 15%.|The cumulative incidence of safety endpoints for the Investigational Treatment group was an average of 13.5% less than for the Control group.|The mean difference is equivalent to the proportion of Investigational Device patients minus the proportion of Control patients experiencing any instance of significant bleeding, neurological deficit or immune/inflammatory allergic response.||-0.003||0.05
70938624|NCT00476151|141377735|SUPERIORITY_OR_OTHER|||||||0.083|TWO_SIDED|95.0|||||ANCOVA|||||||0.083
70938625|NCT04332991|141377747|SUPERIORITY||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.73|1.42|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group.|Outcome measure was adjusted for age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization.||1.42|0.73|
70938626|NCT04332991|141377748|SUPERIORITY||Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.9|1.81|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.81|0.90|
70938627|NCT04332991|141377749|SUPERIORITY||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.84|1.61|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.61|0.84|
71067281|NCT02099110|141642696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.14|||<|0.001|TWO_SIDED|95.0|2.68|6.4||Adjusted Odds Ratio using a logistic regression model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR.|Regression, Logistic|||||6.40|2.68|<0.001
71067282|NCT02099110|141642696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.53|||<|0.001|TWO_SIDED|95.0|1.68|3.83||Adjusted Odds Ratio using a logistic regression model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR.|Regression, Logistic|||||3.83|1.68|<0.001
71112117|NCT03726658|141731073|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 14|Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.48||0.82|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 14. Since this was a phase 1 study, no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.82
70938628|NCT04332991|141377750|SUPERIORITY||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.69|1.38|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure is adjusted for : age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization.||1.38|0.69|
70938629|NCT04332991|141377751|SUPERIORITY||Odds Ratio (OR)|1.56|||||TWO_SIDED|95.0|0.68|3.57|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||3.57|0.68|
70938630|NCT04332991|141377752|SUPERIORITY||Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.54|2.09|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||2.09|0.54|
70938631|NCT04332991|141377753|SUPERIORITY||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.6|2.14|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||2.14|0.60|
70938632|NCT04332991|141377754|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.68|1.34|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.34|0.68|
71112118|NCT03726658|141731073|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 18|Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|2.62||0.61|TWO_SIDED||||||Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 18. Since this was a phase 1 study, no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.61
70938633|NCT04332991|141377755|SUPERIORITY||Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|0.76|2.08|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||2.08|0.76|
70938634|NCT04332991|141377756|SUPERIORITY||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.61|1.72|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.72|0.61|
71067283|NCT02099110|141642696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.95|||<|0.001|TWO_SIDED|95.0|1.92|4.54||Adjusted Odds Ratio using a logistic regression model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR.|Regression, Logistic|||||4.54|1.92|<0.001
71067284|NCT02099110|141642696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.56|||<|0.001|TWO_SIDED|95.0|1.69|3.89|||Regression, Logistic|Adjusted Odds Ratio using a logistic regression model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR.||||3.89|1.69|<0.001
70938635|NCT04332991|141377757|SUPERIORITY||Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|0.84|1.88|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.88|0.84|
70938636|NCT04332991|141377758|SUPERIORITY||Odds Ratio (OR)|1.17|||||TWO_SIDED|95.0|0.85|1.61|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.61|0.85|
71112119|NCT03726658|141731073|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 18|Median Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|2.69||0.47|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 18. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.47
71112120|NCT03726658|141731073|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 21|Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|2.48||0.76|TWO_SIDED||||||Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 21. Since this was a phase 1 study, no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.76
71112121|NCT03726658|141731073|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 21|Median Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|2.51||0.99|TWO_SIDED|||||Change from baseline in treated group compared to change from baseline in placebo group on Day 21|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 21. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.99
71112122|NCT00412958|141731074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.796|TWO_SIDED|95.0|0.24|6.36|||Regression, Logistic|||P-values are from Wald chi-square tests from a logistic regression model with study center and treatment as categorical fixed effects comparing active treatment groups with the placebo group as the reference group.||6.36|0.24|0.796
71112123|NCT00412958|141731074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.447|TWO_SIDED|95.0|0.39|8.36|||Regression, Logistic|||P-values are from Wald chi-square test from a logistic regression model with study center and treatment as categorical fixed effects comparing active treatment groups with the placebo group as the reference group.||8.36|0.39|0.447
70938637|NCT04332991|141377759|SUPERIORITY||Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-1.0|1.8||||||||1.8|-1.0|
70938638|NCT04332991|141377760|SUPERIORITY||Odds Ratio (OR)|1.36|||||TWO_SIDED|95.0|0.61|3.02|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||3.02|0.61|
70938639|NCT04332991|141377761|SUPERIORITY||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.24|2.7|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||2.70|0.24|
70938640|NCT04332991|141377762|SUPERIORITY||Odds Ratio (OR)|2.51|||||TWO_SIDED|95.0|0.78|8.12|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||8.12|0.78|
71112124|NCT00412958|141731074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.28||||0.107|TWO_SIDED|95.0|0.77|13.95|||Regression, Logistic|||P-values are from Wald chi-square test from a logistic regression model with study center and treatment as categorical fixed effects comparing active treatment groups with the placebo group as the reference group.||13.95|0.77|0.107
71112125|NCT00090779|141731075|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.005
71112126|NCT00090779|141731076|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
71112127|NCT03012828|141731131|OTHER|The model was used for predicting population average and 90% 2-sided bootstrapped CI of the baseline-adjusted difference between active and placebo at each time point bound at clinically relevant concentrations.|Slope|-0.0077||||0.4727|TWO_SIDED|90.0|-0.0255|0.0101|||Mixed Models Analysis||The primary mixed effects model analysis revealed a nearly flat dQTcF - plasma concentration gradient|The primary analysis used a mixed-effects model to explore the relationship between the time-matched, baseline-adjusted QTcF (delta (d)QTcF) and moxidectin concentrations. dQTcF was a dependent variable and treatment, time point, and treatment by time point interaction as the independent variables with baseline QTcF as a covariate and time-matched concentrations of moxidectin as a covariate with random effects of intercept and slope for each subject.Concentrations of zero were used for placebo.||0.0101|-0.0255|0.4727
71112128|NCT04855240|141731157|SUPERIORITY||LSM difference|-10.5|STANDARD_ERROR_OF_MEAN|7.61||0.1683|TWO_SIDED|95.0|-25.4|4.4|||ANOVA|||||4.4|-25.4|0.1683
71112129|NCT04855240|141731157|SUPERIORITY||LSM difference|1.6|STANDARD_ERROR_OF_MEAN|7.64||0.8356|TWO_SIDED|95.0|-13.4|16.6|||ANOVA|||||16.6|-13.4|0.8356
71112130|NCT04855240|141731158|SUPERIORITY||Hazard Ratio (HR)|0.831||||0.228|TWO_SIDED|95.0|0.598|1.155|||Log Rank|||||1.155|0.598|0.2280
71112131|NCT04855240|141731158|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.5604|TWO_SIDED|95.0|0.793|1.527|||Log Rank|||||1.527|0.793|0.5604
71112132|NCT04855240|141731159|SUPERIORITY||Risk Difference (RD)|0.11||||0.2457|TWO_SIDED|95.0|-0.05|0.26|||Cochran-Mantel-Haenszel|||||0.26|-0.05|0.2457
71112133|NCT04855240|141731159|SUPERIORITY||Risk Difference (RD)|-0.06||||0.3997|TWO_SIDED|95.0|-0.22|0.09|||Cochran-Mantel-Haenszel|||||0.09|-0.22|0.3997
71112134|NCT04855240|141731160|SUPERIORITY||Risk Difference (RD)|0.07||||0.4771|TWO_SIDED|95.0|-0.09|0.22|||Cochran-Mantel-Haenszel|||||0.22|-0.09|0.4771
71112135|NCT04855240|141731160|SUPERIORITY||Risk Difference (RD)|-0.09||||0.2925|TWO_SIDED|95.0|-0.24|0.06|||Cochran-Mantel-Haenszel|||||0.06|-0.24|0.2925
71112136|NCT04855240|141731161|SUPERIORITY||Risk Difference (RD)|0.07||||0.4628|TWO_SIDED|95.0|-0.09|0.22|||Cochran-Mantel-Haenszel|||||0.22|-0.09|0.4628
70938641|NCT04332991|141377763|SUPERIORITY||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.45|1.05|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||1.05|0.45|
71067285|NCT02099110|141642697|SUPERIORITY_OR_OTHER||Difference in the least squares means|7.61||||0.155|TWO_SIDED|95.0|-2.9|18.13||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||18.13|-2.90|0.155
71067286|NCT02099110|141642697|SUPERIORITY_OR_OTHER||Difference in the least squares means|-4.87||||0.369|TWO_SIDED|95.0|-15.54|5.8||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||5.80|-15.54|0.369
71067287|NCT02099110|141642697|SUPERIORITY_OR_OTHER||Difference in the least squares means|1.81||||0.734|TWO_SIDED|95.0|-8.66|12.27||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||12.27|-8.66|0.734
71067288|NCT02099110|141642697|SUPERIORITY_OR_OTHER||Difference in the least squares means|-9.59||||0.075|TWO_SIDED|95.0|-20.17|0.98||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the least squares means|||||0.98|-20.17|0.075
71067289|NCT02099110|141642698|SUPERIORITY_OR_OTHER||Difference in the least squares means|-2.76||||0.005|TWO_SIDED|95.0|-4.69|-0.83||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.83|-4.69|0.005
71067290|NCT02099110|141642698|SUPERIORITY_OR_OTHER||Difference in the least squares means|-3.01||||0.002|TWO_SIDED|95.0|-4.94|-1.09||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-1.09|-4.94|0.002
71067291|NCT01377922|141642726|OTHER|Estimated via a MMRM with change from baseline (Day 1, Part 2), Day 8, and Day 14 as the dependent variable and terms for treatment, time (Day 8, Day 14), treatment-by-time interaction, and double-blind baseline QMG score as fixed effects and patient as a random effect. The model assumed time effect to be random between patients.||||||0.0452|||||||Mixed Models Analysis|Pairwise contrast at Day 14 from MMRM model.||||||0.0452
71067292|NCT01377922|141642727|OTHER|||||||0.0028||||||Pairwise contrast at Day 14 from MMRM model.|Mixed Models Analysis|||Estimated via a MMRM with change from baseline (Day 1, Part 2), Day 8, and Day 14 as the dependent variable and terms for treatment, time (Day 8, Day 14), treatment-by-time interaction, and double-blind baseline SGI score as fixed effects and patient as a random effect. The model assumed time effect to be random between patients||||0.0028
71067293|NCT01377922|141642728|OTHER|||||||0.6274|||||||Mixed Models Analysis|||Estimated via a MMRM with change from baseline (Day 1, Part 2), Day 8, and Day 14 as the dependent variable and terms for treatment, time (Day 8, Day 14), treatment-by-time interaction, and double-blind baseline T25FW walking speed as fixed effects and patient as a random effect. The model assumed time effect to be random between patients.||||0.6274
71112137|NCT04855240|141731161|SUPERIORITY||Risk Difference (RD)|-0.09||||0.309|TWO_SIDED|95.0|-0.24|0.06|||Cochran-Mantel-Haenszel|||||0.06|-0.24|0.3090
71067294|NCT01377922|141642729|OTHER|||||||0.0267|||||||Mixed Models Analysis|||Estimated via a MMRM with change from baseline (Day 1, Part 2), Day 8, and Day 14 as the dependent variable and terms for treatment, time (Day 8, Day 14), treatment-by-time interaction as fixed effects and patient as a random effect. The model assumed time effect to be random between patients||||0.0267
71067295|NCT03482453|141642787|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least square means (LS means) for the log-transformed parameters were exponentiated to obtain the point estimates and 90 percent (%) Confidence Intervals (CIs) of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|0.881|||||TWO_SIDED|90.0|0.7108|1.0921||||||||1.0921|0.7108|
71112138|NCT04855240|141731162|SUPERIORITY||LSM difference|-17.7|STANDARD_ERROR_OF_MEAN|15.36||0.2494|TWO_SIDED|95.0|-47.8|12.4|||ANOVA|||||12.4|-47.8|0.2494
71112139|NCT04855240|141731162|SUPERIORITY||LSM difference|5.1|STANDARD_ERROR_OF_MEAN|15.42||0.7385|TWO_SIDED|95.0|-25.1|35.4|||ANOVA|||||35.4|-25.1|0.7385
71112140|NCT04855240|141731163|SUPERIORITY||LSM difference|-22.6|STANDARD_ERROR_OF_MEAN|22.91||0.3238|TWO_SIDED|95.0|-67.5|22.3|||ANOVA|||||22.3|-67.5|0.3238
71112141|NCT04855240|141731163|SUPERIORITY||LSM difference|7.8|STANDARD_ERROR_OF_MEAN|22.99||0.7344|TWO_SIDED|95.0|-37.3|52.9|||ANOVA|||||52.9|-37.3|0.7344
71067296|NCT03482453|141642787|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|0.9637|||||TWO_SIDED|90.0|0.8361|1.1107||||||||1.1107|0.8361|
71067297|NCT03482453|141642788|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|0.9317|||||TWO_SIDED|90.0|0.8458|1.0263||||||||1.0263|0.8458|
71067298|NCT03482453|141642793|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|1.0153|||||TWO_SIDED|90.0|0.8977|1.1483||||||||1.1483|0.8977|
71067299|NCT03482453|141642793|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|0.9506|||||TWO_SIDED|90.0|0.874|1.0339||||||||1.0339|0.8740|
71112142|NCT04855240|141731164|SUPERIORITY||LSM difference|-0.3|STANDARD_ERROR_OF_MEAN|1.72||0.8489|TWO_SIDED|95.0|-3.7|3.0|||ANOVA|||||3.0|-3.7|0.8489
71112143|NCT04855240|141731164|SUPERIORITY||LSM difference|1.9|STANDARD_ERROR_OF_MEAN|1.72||0.2768|TWO_SIDED|95.0|-1.5|5.3|||ANOVA|||||5.3|-1.5|0.2768
70938642|NCT04332991|141377764|SUPERIORITY||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.24|2.7|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||2.70|0.24|
70938643|NCT04332991|141377765|SUPERIORITY||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.59|1.59|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||1.59|0.59|
70938644|NCT04332991|141377766|SUPERIORITY||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.3|1.58|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||1.58|0.30|
70938645|NCT04332991|141377767|SUPERIORITY||Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|0.48|3.18|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||3.18|0.48|
70938646|NCT04332991|141377768|SUPERIORITY||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.24|3.96|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||3.96|0.24|
70938647|NCT04332991|141377769|SUPERIORITY||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.73|1.53|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||1.53|0.73|
70852735|NCT01578850|141194338|SUPERIORITY_OR_OTHER||Difference in proportions|7.1||||0.378|TWO_SIDED|95.0|-3.37|17.5|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 70: Week 28||17.50|-3.37|0.378
70938648|NCT04332991|141377770|SUPERIORITY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.92|1.89|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||1.89|0.92|
70938649|NCT04332991|141377771|SUPERIORITY||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.21|2.94|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||2.94|0.21|
70938650|NCT04332991|141377772|SUPERIORITY||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.06|15.74|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||15.74|0.06|
70938651|NCT04332991|141377773|SUPERIORITY||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.69|1.35|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.35|0.69|
70938652|NCT01129011|141377784|SUPERIORITY_OR_OTHER||proportions|11.9||||0.001|TWO_SIDED|95.0|7.9|17.1|||Cochran-Mantel-Haenszel|CMH test stratified by use of low-dose aspirin (Yes/No) at randomization.||The primary efficacy endpoint was the proportion of subjetcs developing gastric ulcers throughout 6 months of study treatment. A summary, including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of gastric ulcers at 6 months. The cumulative proportion of subjects developing gastric ulcers at 6 months was analyzed using the CMH test stratified by use of low-dose aspirin (Yes/No) at randomization.||17.1|7.9|0.001
71067300|NCT03482453|141642794|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|0.9603|||||TWO_SIDED|90.0|0.8861|1.0408||||||||1.0408|0.8861|
71112144|NCT04855240|141731165|SUPERIORITY||LSM difference|-1.2|STANDARD_ERROR_OF_MEAN|2.54||0.6291|TWO_SIDED|95.0|-6.2|3.8|||ANOVA|||||3.8|-6.2|0.6291
71112145|NCT04855240|141731165|SUPERIORITY||LSM difference|2.5|STANDARD_ERROR_OF_MEAN|2.55||0.3182|TWO_SIDED|95.0|-2.5|7.5|||ANOVA|||||7.5|-2.5|0.3182
71112146|NCT04855240|141731166|SUPERIORITY||LSM difference|-4.2|STANDARD_ERROR_OF_MEAN|4.35||0.3299|TWO_SIDED|95.0|-12.8|4.3|||ANOVA|||||4.3|-12.8|0.3299
71112147|NCT04855240|141731166|SUPERIORITY||LSM difference|0.6|STANDARD_ERROR_OF_MEAN|4.37||0.8822|TWO_SIDED|95.0|-7.9|9.2|||ANOVA|||||9.2|-7.9|0.8822
70938653|NCT01129011|141377785|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
70938654|NCT01129011|141377786|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Cochran-Mantel-Haenszel|||||||0.009
70938655|NCT01129011|141377787|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Cochran-Mantel-Haenszel|||||||0.007
70938656|NCT01129011|141377788|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
70938657|NCT01767376|141377794|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardised asymptotic 95% confidence interval (CI) for rSBA GMT ratios for serogroup A between the two groups (Nimenrix+Boostrix Group minus Nimenrix Group) being greater than or equal to (≥) the pre-defined limit of 0.5.|Adjusted GMT ratio|1.19|||||TWO_SIDED|95.0|0.97|1.48|||ANCOVA|||To demonstrate the non-inferiority of Nimenrix co-administered with Boostrix (Nimenrix+Boostrix Group) compared to Nimenrix administered alone (Nimenrix Group) with respect to serum bactericidal assay using rabbit complement (rSBA) geometric mean titers (GMTs) for serogroup A, one month after Nimenrix vaccination.||1.48|0.97|
70941794|NCT04748445|141383937|OTHER||Slope|1.985|STANDARD_ERROR_OF_MEAN|1.23||0.8721|TWO_SIDED|90.0|-1.841|2.238|||Mixed Models Analysis|||EE\_Formant 2 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^0. For estimated value it was 10\^-1).||2.238|-1.841|0.8721
70941795|NCT04748445|141383937|OTHER||Slope|0.6573|STANDARD_ERROR_OF_MEAN|2.191||0.7647|TWO_SIDED|90.0|-2.974|4.288|||Mixed Models Analysis|||EE\_Formant 2 Bandwidth (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^0).||4.288|-2.974|0.7647
71067301|NCT02547220|141642831|SUPERIORITY||Difference in percentage|2.6||||0.6857|TWO_SIDED|95.0|-29.4|34.5|||Fisher Exact||Difference in percentage was calculated by the difference in percentage of new or worsening TG at 6 months between CINRYZE and placebo|||34.5|-29.4|0.6857
71112148|NCT04855240|141731167|SUPERIORITY||LSM difference|-7.1|STANDARD_ERROR_OF_MEAN|8.62||0.4094|TWO_SIDED|95.0|-24.0|9.8|||ANOVA|||||9.8|-24.0|0.4094
71112149|NCT04855240|141731167|SUPERIORITY||LSM difference|3.4|STANDARD_ERROR_OF_MEAN|8.65||0.6901|TWO_SIDED|95.0|-13.5|20.4|||ANOVA|||||20.4|-13.5|0.6901
70938658|NCT01767376|141377794|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardised asymptotic 95% confidence interval (CI) for rSBA GMT ratios for serogroup C between the two groups (Nimenrix+Boostrix Group minus Nimenrix Group) being greater than or equal to (≥) the pre-defined limit of 0.5.|Adjusted GMT ratio|1.12|||||TWO_SIDED|95.0|0.85|1.47|||ANCOVA|||To demonstrate the non-inferiority of Nimenrix co-administered with Boostrix (Nimenrix+Boostrix Group) compared to Nimenrix administered alone (Nimenrix Group) with respect to serum bactericidal assay using rabbit complement (rSBA) geometric mean titers (GMTs) for serogroup C, one month after Nimenrix vaccination.||1.47|0.85|
70938659|NCT01767376|141377794|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardised asymptotic 95% confidence interval (CI) for rSBA GMT ratios for serogroup W-135 between the two groups (Nimenrix+Boostrix Group minus Nimenrix Group) being greater than or equal to (≥) the pre-defined limit of 0.5.|Adjusted GMT ratio|1.06|||||TWO_SIDED|95.0|0.86|1.32|||ANCOVA|||To demonstrate the non-inferiority of Nimenrix co-administered with Boostrix (Nimenrix+Boostrix Group) compared to Nimenrix administered alone (Nimenrix Group) with respect to serum bactericidal assay using rabbit complement (rSBA) geometric mean titers (GMTs) for serogroup W-135, one month after Nimenrix vaccination.||1.32|0.86|
71067302|NCT03771560|141642855|OTHER||Mean Difference (Final Values)|-2.4||||0.56|TWO_SIDED|95.0|-11.3|6.4|||Paired Sample t-test|||The parent-reported change in mean ABC total score from baseline to week 12.||6.4|-11.3|0.56
71067303|NCT03771560|141642856|OTHER||Mean Difference (Final Values)|1.2||||0.68|TWO_SIDED|95.0|-5.2|7.6|||Paired Sample t-test|||The teacher-reported change in mean ABC total score from baseline to week 12.||7.6|-5.2|0.68
71067304|NCT03771560|141642857|OTHER||Mean Difference (Final Values)|-7.8||||0.095|TWO_SIDED|95.0|-17.3|1.6|||Paired Sample t-test|||The parent-reported change in mean SRS total score from baseline to week 12.||1.6|-17.3|0.095
71067305|NCT03771560|141642858|OTHER||Median Difference (Final Values)|-0.5||||0.95|TWO_SIDED|95.0|-7.0|13.5|||Wilcoxon (Mann-Whitney)|||The teacher-reported change in mean SRS total score from baseline to week 12.||13.5|-7.0|0.95
71067306|NCT03771560|141642859|OTHER||Mean Difference (Final Values)|-0.8||||0.69|TWO_SIDED|95.0|-5.2|3.5|||Paired Sample t-test|||The parent-reported change in mean PedsQL total score from baseline to week 12.||3.5|-5.2|0.69
71067307|NCT02887183|141642860|OTHER||Least Squared Geometric Mean Ratio|0.632|||<|0.0001|TWO_SIDED|95.0|0.5865|0.681|||ANCOVA|||||0.6810|0.5865|<.0001
71067308|NCT02887183|141642861|OTHER||Least Squared Mean|-7.57|||<|0.0001|TWO_SIDED|95.0|-7.98|-7.15|||ANCOVA|||LAVi||-7.15|-7.98|<.0001
71067309|NCT02887183|141642861|OTHER||Least Squared Mean|-12.25|||<|0.0001|TWO_SIDED|95.0|-12.92|-11.58|||ANCOVA|||LVEDVi||-11.58|-12.92|<.0001
71067310|NCT02887183|141642861|OTHER||Least Squared Mean|-15.29|||<|0.0001|TWO_SIDED|95.0|-16.03|-14.55|||ANCOVA|||LVESVi||-14.55|-16.03|<.0001
71067311|NCT02887183|141642862|OTHER||Least Squared Mean|9.37|||<|0.001|TWO_SIDED|95.0|8.84|9.9|||ANCOVA|||||9.90|8.84|<.001
71067312|NCT02887183|141642863|OTHER|Pearson's Correlation|||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||LVESVi, LVEDVi, LAVi. LVEF||||<.0001
71067313|NCT02887183|141642864|OTHER|Pearson's Correlation|||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||LVESVi, LVEDVi, LAVi. LVEF||||<.0001
71067314|NCT02887183|141642865|OTHER|Pearson's Correlation|||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects with new onset HF and/or RAAS naïve||||<.0001
71067315|NCT02887183|141642865|OTHER|Pearson's Correlation||||||0.0003|TWO_SIDED|95.0|||||t-test, 2 sided|||"Subjects with HFrEF and low NT-proBNP"||||0.0003
71067316|NCT02887183|141642865|OTHER|Pearson's Correlation||||||0.0956|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects not receiving target dose||||0.0956
71067317|NCT02887183|141642866|OTHER|Pearson's Correlation||||||0.006|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects with new onset HF and/or RAAS naïve||||0.0060
71067318|NCT02887183|141642866|OTHER|Pearson's Correlation||||||0.0012|TWO_SIDED|95.0|||||t-test, 2 sided|||"Subjects with HFrEF and low NT-proBNP"||||0.0012
71067319|NCT02887183|141642866|OTHER|Pearson's Correlation||||||0.0181|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects not receiving target dose||||0.0181
71067320|NCT02887183|141642867|OTHER|Pearson's Correlation||||||0.2498|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects with new onset HF and/or RAAS naïve||||0.2498
71067321|NCT02887183|141642867|OTHER|Pearson's Correlation||||||0.0495|TWO_SIDED|95.0|||||t-test, 2 sided|||"Subjects with HFrEF and low NT-proBNP"||||0.0495
71067322|NCT02887183|141642867|OTHER|Pearson's Correlation||||||0.2685|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects not receiving target dose||||0.2685
71067323|NCT02887183|141642868|OTHER|Pearson's Correlation||||||0.0029|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects with new onset HF and/or RAAS naïve||||0.0029
71067324|NCT02887183|141642868|OTHER|Pearson's Correlation||||||0.0011|TWO_SIDED|95.0|||||t-test, 2 sided|||"Subjects with HFrEF and low NT-proBNP"||||0.0011
71067325|NCT02887183|141642868|OTHER|Pearson's Correlation||||||0.0012|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects not receiving target dose||||0.0012
71067326|NCT02887183|141642869|OTHER||Least Squared Mean|9.32|||<|0.0001|TWO_SIDED|95.0|7.94|10.69|||ANCOVA|||||10.69|7.94|<.0001
71067327|NCT06047366|141642879|OTHER|||||||0.18||||||p \< 0.05 was used as the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||||||0.18
71067328|NCT06047366|141642880|OTHER|||||||0.09||||||p \< 0.05 was used as the threshold for statistical significance|Log Rank|||||||0.09
71067329|NCT03483961|141642953|SUPERIORITY|||||||0.0015||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 2 vs. Group 1.||Groups 2-8 are compared to Group 1.||||0.0015
70938660|NCT01767376|141377794|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardised asymptotic 95% confidence interval (CI) for rSBA GMT ratios for serogroup Y between the two groups (Nimenrix+Boostrix Group minus Nimenrix Group) being greater than or equal to (≥) the pre-defined limit of 0.5.|Adjusted GMT ratio|1.27|||||TWO_SIDED|95.0|1.02|1.59|||ANCOVA|||To demonstrate the non-inferiority of Nimenrix co-administered with Boostrix (Nimenrix+Boostrix Group) compared to Nimenrix administered alone (Nimenrix Group) with respect to serum bactericidal assay using rabbit complement (rSBA) geometric mean titers (GMTs) for serogroup Y, one month after Nimenrix vaccination.||1.59|1.02|
70941796|NCT04748445|141383937|OTHER||Slope|0.6504|STANDARD_ERROR_OF_MEAN|8.958||0.4692|TWO_SIDED|90.0|-0.8341|2.135|||Mixed Models Analysis|||EE\_Formant 3 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||2.135|-0.8341|0.4692
71067330|NCT03483961|141642953|SUPERIORITY|||||||0.0761||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 3 vs. Group 1.||Groups 2-8 are compared to Group 1||||0.0761
71067331|NCT03483961|141642953|SUPERIORITY|||||||0.9317||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 4 vs. Group 1.||Groups 2-8 are compared to Group 1.||||0.9317
71067332|NCT03483961|141642953|SUPERIORITY||||||<|0.0001||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 5 vs. Group 1.||Groups 2-8 are compared to Group 1.||||<.0001
71067333|NCT03483961|141642953|SUPERIORITY|||||||0.0045||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 6 vs. Group 1.||Groups 2-8 are compared to Group 1.||||0.0045
71067334|NCT03483961|141642953|SUPERIORITY|||||||0.1437||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 7 vs. Group 1.||Groups 2-8 are compared to Group 1.||||0.1437
71067335|NCT03483961|141642953|SUPERIORITY|||||||0.3216||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 8 vs. Group 1.||Groups 2-8 are compared to Group 1.||||0.3216
71067336|NCT00267969|141642966|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
71067337|NCT00267969|141642966|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control for the multiplicity for the primary endpoint analysis, the Holm's procedure was used at an overall significance level of 0.05|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significance level of 0.05. Sample Size: With 750 patients (250 in each treatment group), simulation studies were conducted to calculate the power to detect a treatment difference in the primary endpoint between ustekinumab groups and placebo using a CMH test stratified by baseline weight \[\<=90kg vs \> 90 kg). For all the scenarios evaluated, the power is \>99% at an overall significance level of 0.05.||||<0.001
71112150|NCT04855240|141731168|SUPERIORITY||LSM difference|-5.1|STANDARD_ERROR_OF_MEAN|8.59||0.5536|TWO_SIDED|95.0|-21.9|11.7|||ANOVA|||||11.7|-21.9|0.5536
71112151|NCT04855240|141731168|SUPERIORITY||LSM difference|2.4|STANDARD_ERROR_OF_MEAN|8.64||0.7811|TWO_SIDED|95.0|-14.5|19.3|||ANOVA|||||19.3|-14.5|0.7811
71067338|NCT00267969|141642967|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel(CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
71067339|NCT00267969|141642967|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control the multiplicity for the primary and the secondary endpoint analyses, Holm's procedure was used but the two comparisons for the primary endpoint and the two comparisons for the 1st second endpoint analyses need to be significant first|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significance level of 0.05.||||<0.001
71112152|NCT04855240|141731169|SUPERIORITY||LSM difference|-0.2|STANDARD_ERROR_OF_MEAN|0.29||0.5267|TWO_SIDED|95.0|-0.8|0.4|||ANOVA|||||0.4|-0.8|0.5267
71112153|NCT04855240|141731169|SUPERIORITY||LSM difference|0.3|STANDARD_ERROR_OF_MEAN|0.29||0.3228|TWO_SIDED|95.0|-0.3|0.9|||ANOVA|||||0.9|-0.3|0.3228
71067340|NCT00267969|141642968|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|Treatment and patient's baseline weight (≤ 90kg vs \> 90 kg) as factors in the model||||||<0.001
71067341|NCT00267969|141642968|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control the multiplicity for the primary and the secondary endpoint analyses, Holm's procedure was used but the two comparisons for the primary endpoint and the two comparisons for the 1st second endpoint analyses need to be significant first|ANOVA on van der Waerden normal scores|Treatment and patient's baseline weight (≤ 90kg vs \> 90 kg) as factors in the model||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significance level of 0.05.||||<0.001
71067342|NCT00267969|141642969|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
71112154|NCT04855240|141731170|SUPERIORITY||LSM difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.7617|TWO_SIDED|95.0|-0.5|0.4|||ANOVA|||||0.4|-0.5|0.7617
71112155|NCT04855240|141731170|SUPERIORITY||LSM difference|0.1|STANDARD_ERROR_OF_MEAN|0.24||0.6241|TWO_SIDED|95.0|-0.4|0.6|||ANOVA|||||0.6|-0.4|0.6241
71112156|NCT04855240|141731171|SUPERIORITY||LSM difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.3442|TWO_SIDED|95.0|-0.5|0.2|||ANOVA|||||0.2|-0.5|0.3442
70938661|NCT01767376|141377795|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group), in terms of percentage of subjects with anti-D concentrations ≥ 1.0 IU/mL, being greater than or equal to (≥) the pre-defined limit of -10%.|Difference in percentage|-2.14|||||TWO_SIDED|95.0|-7.88|3.53||||||To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) in terms of anti-diphtheria toxoid (anti-D) antibody concentrations one month after Boostrix vaccination.||3.53|-7.88|
71067343|NCT00267969|141642969|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
71067344|NCT00267969|141642969|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||To control the overall multiplicity, the combined groups was tested first and each dose will then be tested; but the primary and the 1st 2 secondary endpoint analyses need to be significant before this endpoint can be tested|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||Null Hypothesis: No difference between combined maintenance group and the combined withdrawal group, ustekinumab 90 mg maintenance group and the withdrawal group, ustekinumab 45 mg maintenance group and the withdrawal group at an overall significance level of 0.05.||||0.001
71067345|NCT01309360|141642979|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1
71067346|NCT01309360|141642979|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1
71067347|NCT01309360|141642979|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1
71067348|NCT01309360|141642980|SUPERIORITY_OR_OTHER|||||||0||95.0|||||Kruskal-Wallis|||||||0
71067349|NCT01309360|141642981|SUPERIORITY_OR_OTHER|||||||0.059||95.0|||||Fisher Exact|||||||0.059
71067350|NCT01309360|141642981|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71067351|NCT01309360|141642981|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Fisher Exact|||||||0.2
71112157|NCT04855240|141731171|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.7896|TWO_SIDED|95.0|-0.3|0.4|||ANOVA|||||0.4|-0.3|0.7896
71112158|NCT04855240|141731172|SUPERIORITY||LSM difference|-0.3|STANDARD_ERROR_OF_MEAN|0.49||0.6003|TWO_SIDED|95.0|-1.2|0.7|||ANOVA|||||0.7|-1.2|0.6003
70941797|NCT04748445|141383937|OTHER||Slope|-0.09459|STANDARD_ERROR_OF_MEAN|1.255||0.94|TWO_SIDED|90.0|-2.174|1.985|||Mixed Models Analysis|||EE\_Formant 3 Bandwidth (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^0).||1.985|-2.174|0.9400
71067352|NCT01309360|141642982|SUPERIORITY_OR_OTHER|||||||0.675||95.0|||||Fisher Exact|||||||0.675
71112159|NCT04855240|141731172|SUPERIORITY||LSM difference|0.4|STANDARD_ERROR_OF_MEAN|0.49||0.4086|TWO_SIDED|95.0|-0.6|1.4|||ANOVA|||||1.4|-0.6|0.4086
71067353|NCT01309360|141642982|SUPERIORITY_OR_OTHER|||||||0.087||95.0|||||Fisher Exact|||||||0.087
71067354|NCT01309360|141642982|SUPERIORITY_OR_OTHER|||||||0.348||95.0|||||Fisher Exact|||||||0.348
71067355|NCT01309360|141642983|SUPERIORITY_OR_OTHER|||||||0.247||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.247
71067356|NCT01309360|141642983|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71067357|NCT01309360|141642983|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71067358|NCT01309360|141642984|SUPERIORITY_OR_OTHER|||||||0.116||95.0|||||Fisher Exact|||||||0.116
71067359|NCT01309360|141642984|SUPERIORITY_OR_OTHER|||||||0.116||95.0|||||Fisher Exact|||||||0.116
71067360|NCT01309360|141642984|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1
71067361|NCT02308540|141642992|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 1 GMC Ratio|0.31||||0.0025|TWO_SIDED|90.0|0.17|0.57|||t-test, 2 sided|||||0.57|0.17|0.0025
71067362|NCT02308540|141642992|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 5 GMC Ratio|0.74||||0.454|TWO_SIDED|90.0|0.38|1.45|||t-test, 2 sided|||||1.45|0.38|0.4540
71067363|NCT02308540|141642992|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 6A GMC Ratio|4.69||||0.0003|TWO_SIDED|90.0|2.46|8.94|||t-test, 2 sided|||||8.94|2.46|0.0003
71067364|NCT02308540|141642992|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 6B GMC Ratio|2.22||||0.046|TWO_SIDED|90.0|1.16|4.24|||t-test, 2 sided|||||4.24|1.16|0.0460
71067365|NCT02308540|141642992|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 7F GMC Ratio|0.76||||0.3365|TWO_SIDED|90.0|0.47|1.22|||t-test, 2 sided|||||1.22|0.47|0.3365
71067366|NCT02308540|141642992|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 9V GMC Ratio|0.56||||0.0313|TWO_SIDED|90.0|0.37|0.87|||t-test, 2 sided|||||0.87|0.37|0.0313
71067367|NCT02308540|141642992|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 14 GMC Ratio|1.08||||0.806|TWO_SIDED|90.0|0.65|1.79|||t-test, 2 sided|||||1.79|0.65|0.8060
71067368|NCT02308540|141642992|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 19A GMC Ratio|1.74||||0.2044|TWO_SIDED|90.0|0.84|3.58|||t-test, 2 sided|||||3.58|0.84|0.2044
71112160|NCT04855240|141731173|SUPERIORITY||LSM difference|-0.4|STANDARD_ERROR_OF_MEAN|0.61||0.4958|TWO_SIDED|95.0|-1.6|0.8|||ANOVA|||||0.8|-1.6|0.4958
71112161|NCT04855240|141731173|SUPERIORITY||LSM difference|0.5|STANDARD_ERROR_OF_MEAN|0.61||0.4595|TWO_SIDED|95.0|-0.8|1.7|||ANOVA|||||1.7|-0.8|0.4595
71112162|NCT04855240|141731174|SUPERIORITY||Risk Difference (RD)|0.08||||0.1686|TWO_SIDED|95.0|-0.04|0.19|||Cochran-Mantel-Haenszel|||||0.19|-0.04|0.1686
71067369|NCT02308540|141642992|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 19F GMC Ratio|1.67||||0.149|TWO_SIDED|90.0|0.93|3.02|||t-test, 2 sided|||||3.02|0.93|0.1490
71067370|NCT02308540|141642992|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 23F GMC Ratio|1.13||||0.7565|TWO_SIDED|90.0|0.59|2.15|||t-test, 2 sided|||||2.15|0.59|0.7565
71067371|NCT02308540|141642993|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 1 GMC Ratio|0.75||||0.2653|TWO_SIDED|90.0|0.54|1.31|||Two-tailed from z-test|||||1.31|0.54|0.2653
71067372|NCT02308540|141642993|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 5 GMC Ratio|0.69||||0.2059|TWO_SIDED|90.0|0.45|1.2|||Two-tailed from z-test|||||1.20|0.45|0.2059
71067373|NCT02308540|141642993|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 6A GMC Ratio|0.84||||0.5664|TWO_SIDED|90.0|0.55|1.54|||Two-tailed from z-test|||||1.54|0.55|0.5664
71067374|NCT02308540|141642993|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 6B GMC Ratio|0.82||||0.4456|TWO_SIDED|90.0|0.57|1.31|||Two-tailed from z-test|||||1.31|0.57|0.4456
71067375|NCT02308540|141642993|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 7F GMC Ratio|0.74||||0.2189|TWO_SIDED|90.0|0.52|1.14|||Two-tailed from z-test|||||1.14|0.52|0.2189
71067376|NCT02308540|141642993|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 9V GMC Ratio|0.6||||0.097|TWO_SIDED|90.0|0.38|1.03|||Two-tailed from z-test|||||1.03|0.38|0.0970
70852736|NCT01578850|141194338|SUPERIORITY_OR_OTHER||Difference in proportions|17.3||||0.004|TWO_SIDED|95.0|7.12|27.56|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 70: Week 36||27.56|7.12|0.004
71067377|NCT02308540|141642993|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 14 GMC Ratio|1.76||||0.0713|TWO_SIDED|90.0|1.02|2.79|||Two-tailed from z-test|||||2.79|1.02|0.0713
71067378|NCT02308540|141642993|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 19A GMC Ratio|0.71||||0.3443|TWO_SIDED|90.0|0.42|1.35|||Two-tailed from z-test|||||1.35|0.42|0.3443
71067379|NCT02308540|141642993|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 19F GMC Ratio|0.76||||0.3278|TWO_SIDED|90.0|0.48|1.23|||Two-tailed from z-test|||||1.23|0.48|0.3278
70852737|NCT01578850|141194338|SUPERIORITY_OR_OTHER||Difference in proportions|18.5||||0.001|TWO_SIDED|95.0|8.4|28.55|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 70: Week 44||28.55|8.40|0.001
71067380|NCT02308540|141642993|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 23F GMC Ratio|0.65||||0.2039|TWO_SIDED|90.0|0.4|1.16|||Two-tailed from z-test|||||1.16|0.40|0.2039
71067381|NCT02308540|141642994|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 1 GMC Ratio|0.89||||0.255|TWO_SIDED|90.0|0.74|1.06|||t-test, 2 sided|||||1.06|0.74|0.2550
71067382|NCT02308540|141642994|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 5 GMC Ratio|1.2||||0.0865|TWO_SIDED|90.0|1.01|1.43|||t-test, 2 sided|||||1.43|1.01|0.0865
71067383|NCT02308540|141642994|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 6A GMC Ratio|0.56||||0.0006|TWO_SIDED|90.0|0.43|0.74|||t-test, 2 sided|||||0.74|0.43|0.0006
71067384|NCT02308540|141642994|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 6B GMC Ratio|0.43|||<|0.0001|TWO_SIDED|90.0|0.33|0.57|||t-test, 2 sided|||||0.57|0.33|<0.0001
71067385|NCT02308540|141642994|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 7F GMC Ratio|0.56|||<|0.0001|TWO_SIDED|90.0|0.47|0.68|||t-test, 2 sided|||||0.68|0.47|<0.0001
71067386|NCT02308540|141642994|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 9V GMC Ratio|0.49|||<|0.0001|TWO_SIDED|90.0|0.41|0.59|||t-test, 2 sided|||||0.59|0.41|<0.0001
71067387|NCT02308540|141642994|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 14 GMC Ratio|1.11||||0.5234|TWO_SIDED|90.0|0.85|1.45|||t-test, 2 sided|||||1.45|0.85|0.5234
71067388|NCT02308540|141642994|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 19A GMC Ratio|0.29|||<|0.0001|TWO_SIDED|90.0|0.22|0.36|||t-test, 2 sided|||||0.36|0.22|<0.0001
71067389|NCT02308540|141642994|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 19F GMC Ratio|0.72||||0.004|TWO_SIDED|90.0|0.6|0.87|||t-test, 2 sided|||||0.87|0.60|0.0040
71067390|NCT02308540|141642994|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 23F GMC Ratio|0.58||||0.0001|TWO_SIDED|90.0|0.46|0.73|||t-test, 2 sided|||||0.73|0.46|0.0001
71067391|NCT02308540|141642996|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 1|-1.0|||||TWO_SIDED|90.0|-5.13|2.66||||||||2.66|-5.13|
71067392|NCT02308540|141642996|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 5|3.0|||||TWO_SIDED|90.0|-1.1|7.95||||||||7.95|-1.10|
71067393|NCT02308540|141642996|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 6A|-12.0|||||TWO_SIDED|90.0|-20.94|-2.97||||||||-2.97|-20.94|
71067394|NCT02308540|141642996|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 6B|-7.9|||||TWO_SIDED|90.0|-15.0|-1.01||||||||-1.01|-15.0|
71067395|NCT02308540|141642996|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 7F|-3.0|||||TWO_SIDED|90.0|-7.95|1.1||||||||1.10|-7.95|
71067396|NCT02308540|141642996|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 9V|-3.0|||||TWO_SIDED|90.0|-9.17|2.9||||||||2.90|-9.17|
71067397|NCT02308540|141642996|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 14|1.0|||||TWO_SIDED|90.0|-4.0|6.27||||||||6.27|-4.00|
71067398|NCT02308540|141642996|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 19A|-5.9|||||TWO_SIDED|90.0|-12.38|0.17||||||||0.17|-12.38|
71067399|NCT02308540|141642996|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 19F|0.0|||||TWO_SIDED|90.0|-4.22|4.33||||||||4.33|-4.22|
71067400|NCT02308540|141642996|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 23F|-6.0|||||TWO_SIDED|90.0|-12.77|0.4||||||||0.40|-12.77|
70938662|NCT01767376|141377795|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group), in terms of percentage of subjects with anti-T concentrations ≥ 1.0 IU/mL, being greater than or equal to (≥) the pre-defined limit of -10%.|Difference in percentage|-0.44|||||TWO_SIDED|95.0|-2.48|1.26||||||To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) in terms of anti-tetanus toxoid (anti-T) antibody concentrations one month after Boostrix vaccination.||1.26|-2.48|
71067401|NCT02308540|141642998|OTHER|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 1|9.1|||||TWO_SIDED|90.0|-15.55|36.11||||||||36.11|-15.55|
71067402|NCT02308540|141642998|OTHER|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 5|0.0|||||TWO_SIDED|90.0|-18.56|18.56||||||||18.56|-18.56|
71067403|NCT02308540|141642998|OTHER|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 6B|5.0|||||TWO_SIDED|90.0|-12.35|22.97||||||||22.97|-12.35|
71067404|NCT02308540|141642998|OTHER|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 14|5.3|||||TWO_SIDED|90.0|-12.15|24.01||||||||24.01|-12.15|
71067405|NCT02308540|141642998|OTHER|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 19A|-5.9|||||TWO_SIDED|90.0|-26.41|11.01||||||||11.01|-26.41|
71067406|NCT02308540|141642998|OTHER|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 19F|5.0|||||TWO_SIDED|90.0|-11.64|22.97||||||||22.97|-11.64|
71067407|NCT02649439|141643048|SUPERIORITY|||||||0.4852|||||||Wilcoxon signed rank test|||||||0.4852
71067408|NCT02649439|141643049|SUPERIORITY|||||||0.3269|||||||Wilcoxon signed rank test|||||||0.3269
71067409|NCT02649439|141643052|SUPERIORITY|||||||0.0255||||||The reported p-value is representative of the PBMCs in monocyte nonclassical between responders and non-responders.|Mann Whitney Test|||||||0.0255
71067410|NCT02649439|141643052|OTHER|||||||0.0021||||||The reported p-value is representative of the PBMCs in monocyte nonclassical PD-L1+ between responders and non-responders.|Mann Whitney Test|||||||0.0021
71067411|NCT02649439|141643052|SUPERIORITY|||||||0.0486||||||The reported p-value is representative of the PBMCs in monocyte PD-1+ between responders and non-responders.|Mann Whitney Test|||||||0.0486
71067412|NCT02649439|141643053|SUPERIORITY|||||||0.7317||||||The reported p-value is representative of the PBMCs in CD4 between responders and non-responders.|Mann Whitney Test|||||||0.7317
71067413|NCT02649439|141643053|SUPERIORITY|||||||0.7545||||||The reported p-value is representative of the PBMCs in CD8 between responders and non-responders.|Mann Whitney Test|||||||0.7545
71067414|NCT02649439|141643053|SUPERIORITY|||||||0.531||||||The reported p-value is representative of the PBMCs in Treg between responders and non-responders.|Mann Whitney Test|||||||0.5310
71067415|NCT02649439|141643053|SUPERIORITY|||||||0.8451||||||The reported p-value is representative of the PBMCs in NK between responders and non-responders.|Mann Whitney Test|||||||0.8451
71067416|NCT02649439|141643053|SUPERIORITY|||||||0.9377||||||The reported p-value is representative of the PBMCs in MDSC between responders and non-responders.|Mann Whitney Test|||||||0.9377
71067417|NCT02649439|141643054|SUPERIORITY|||||||0.2012||||||The reported p-value is representative of the % of CD4 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.2012
71067418|NCT02649439|141643054|SUPERIORITY|||||||0.4891||||||The reported p-value is representative of the % of CD8 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.4891
71067419|NCT02649439|141643054|SUPERIORITY|||||||0.4609||||||The reported p-value is representative of the % of Tregs in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.4609
71067420|NCT02649439|141643054|SUPERIORITY|||||||0.0012||||||The reported p-value is representative of the % of NK in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.0012
71067421|NCT02649439|141643054|SUPERIORITY|||||||0.0825||||||The reported p-value is representative of the % of MDSC in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.0825
71067422|NCT02649439|141643054|SUPERIORITY|||||||0.5988||||||The reported p-value is representative of the % of naïve CD4 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.5988
71067423|NCT02649439|141643054|SUPERIORITY|||||||0.592|||||||Wilcoxon signed rank test|The reported p-value is representative of the % of naïve CD8 in PBMCs at Day 1 and Day 29.||||||0.5920
71067424|NCT02649439|141643054|SUPERIORITY|||||||0.6221||||||The reported p-value is representative of the % of CD4 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.6221
71067425|NCT02649439|141643054|SUPERIORITY|||||||0.7334||||||The reported p-value is representative of the % of CD8 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.7334
71067426|NCT02649439|141643054|OTHER|||||||0.791||||||The reported p-value is representative of the % of Tregs in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.7910
71067427|NCT02649439|141643054|SUPERIORITY|||||||0.5186||||||The reported p-value is representative of the % of NK in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.5186
71067428|NCT02649439|141643054|SUPERIORITY|The reported p-value is representative of the % of MDSC in PBMCs at Day 1 and Day 29.||||||0.5186|||||||Wilcoxon signed rank test|||||||0.5186
71067429|NCT02649439|141643054|SUPERIORITY|||||||0.9097||||||The reported p-value is representative of the % of naïve CD4 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.9097
71067430|NCT02649439|141643054|SUPERIORITY|||||||0.7334||||||The reported p-value is representative of the % of naïve CD8 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.7334
71112163|NCT04855240|141731174|SUPERIORITY||Risk Difference (RD)|0.0||||0.8333|TWO_SIDED|95.0|-0.1|0.11|||Cochran-Mantel-Haenszel|||||0.11|-0.10|0.8333
70938663|NCT01767376|141377796|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group) for GMC ratios of antibodies against the pertussis (PT) antigen, being greater than or equal to (≥) the predefined limit of 0.67.|Adjusted GMC ratio|0.76|||||TWO_SIDED|95.0|0.66|0.89|||ANCOVA|||To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) with respect to geometric mean concentrations (GMCs) of antibodies against pertussis toxoid (PT), one month after Boostrix vaccination.||0.89|0.66|
70938664|NCT01767376|141377796|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group) for GMC ratios of antibodies against the filamentous haemagglutinin (FHA) antigen, being greater than or equal to (≥) the predefined limit of 0.67.|Adjusted GMC ratio|0.57|||||TWO_SIDED|95.0|0.5|0.65|||ANCOVA|||To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) with respect to geometric mean concentrations (GMCs) of antibodies against filamentous haemagglutinin (FHA), one month after Boostrix vaccination.||0.65|0.50|
71067431|NCT01028014|141643128|SUPERIORITY_OR_OTHER||||||>|0.05||||||P values comparing differences across groups, as well as within group changes, were all \>0.05.P-values were not adjusted for multiple testing; p\<0.05 was considered statistically significant.|Wilcoxon (Mann-Whitney)|||Using difference in EMG amplitude as primary outcome, assuming standard deviation of 6, we had greater than 80% power to detect a 10-microvolt change in urethral muscle activity with sample size of 9 participants per group. Due to non-normality and small sample sizes, non-parametric tests were used and data presented as median (IQR). Kruskal-Wallis p-values are reported to compare median scores across groups. Wilcoxon sign-test p-values are reported to evaluate 2-week change within groups.||||>0.05
71112164|NCT04855240|141731175|SUPERIORITY||Risk Difference (RD)|0.09||||0.1939|TWO_SIDED|95.0|-0.02|0.2|||Cochran-Mantel-Haenszel|||||0.20|-0.02|0.1939
71112165|NCT04855240|141731175|SUPERIORITY||Risk Difference (RD)|0.0||||0.9595|TWO_SIDED|95.0|-0.1|0.1|||Cochran-Mantel-Haenszel|||||0.10|-0.10|0.9595
71112166|NCT04855240|141731176|SUPERIORITY||Risk Difference (RD)|0.09||||0.1894|TWO_SIDED|95.0|-0.02|0.2|||Cochran-Mantel-Haenszel|||||0.20|-0.02|0.1894
71112167|NCT04855240|141731176|SUPERIORITY||Risk Difference (RD)|0.0||||0.9595|TWO_SIDED|95.0|-0.1|0.1|||Cochran-Mantel-Haenszel|||||0.10|-0.10|0.9595
71112168|NCT04855240|141731177|SUPERIORITY||Risk Difference (RD)|0.09||||0.7117|TWO_SIDED|95.0|-0.06|0.24|||Cochran-Mantel-Haenszel|||||0.24|-0.06|0.7117
71112169|NCT04855240|141731177|SUPERIORITY||Risk Difference (RD)|-0.04||||0.7599|TWO_SIDED|95.0|-0.19|0.1|||Cochran-Mantel-Haenszel|||||0.10|-0.19|0.7599
71112170|NCT04855240|141731178|SUPERIORITY||Risk Difference (RD)|0.0||||0.707|TWO_SIDED|95.0|-0.16|0.16|||Cochran-Mantel-Haenszel|||||0.16|-0.16|0.7070
71112171|NCT04855240|141731178|SUPERIORITY||Risk Difference (RD)|-0.04||||0.6877|TWO_SIDED|95.0|-0.2|0.12|||Cochran-Mantel-Haenszel|||||0.12|-0.20|0.6877
71112172|NCT04855240|141731179|SUPERIORITY||Risk Difference (RD)|-0.07||||0.869|TWO_SIDED|95.0|-0.22|0.07|||Cochran-Mantel-Haenszel|||||0.07|-0.22|0.8690
71112173|NCT04855240|141731179|SUPERIORITY||Risk Difference (RD)|-0.04||||0.379|TWO_SIDED|95.0|-0.19|0.1|||Cochran-Mantel-Haenszel|||||0.10|-0.19|0.3790
71112174|NCT04855240|141731180|SUPERIORITY||LSM difference|5.9|STANDARD_ERROR_OF_MEAN|3.49||0.0897|TWO_SIDED|95.0|-0.9|12.8|||ANOVA|||||12.8|-0.9|0.0897
71112175|NCT04855240|141731180|SUPERIORITY||LSM difference|-0.2|STANDARD_ERROR_OF_MEAN|3.5||0.9434|TWO_SIDED|95.0|-7.1|6.7|||ANOVA|||||6.7|-7.1|0.9434
71112176|NCT04855240|141731181|SUPERIORITY||Risk Difference (RD)|0.09||||0.8355|TWO_SIDED|95.0|-0.04|0.21|||Cochran-Mantel-Haenszel|||||0.21|-0.04|0.8355
71112177|NCT04855240|141731181|SUPERIORITY||Risk Difference (RD)|0.02||||0.3561|TWO_SIDED|95.0|-0.12|0.15|||Cochran-Mantel-Haenszel|||||0.15|-0.12|0.3561
71112178|NCT04855240|141731182|SUPERIORITY||Risk Difference (RD)|0.04||||0.9413|TWO_SIDED|95.0|-0.06|0.13|||Cochran-Mantel-Haenszel|||||0.13|-0.06|0.9413
71112179|NCT04855240|141731182|SUPERIORITY||Risk Difference (RD)|-0.04||||0.7819|TWO_SIDED|95.0|-0.15|0.07|||Cochran-Mantel-Haenszel|||||0.07|-0.15|0.7819
71112180|NCT04855240|141731183|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.22||0.8461|TWO_SIDED|95.0|-0.5|0.4|||ANOVA|||||0.4|-0.5|0.8461
71112181|NCT04855240|141731183|SUPERIORITY||LSM difference|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1727|TWO_SIDED|95.0|-0.1|0.7|||ANOVA|||||0.7|-0.1|0.1727
71112182|NCT04855240|141731184|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.22||0.9022|TWO_SIDED|95.0|-0.4|0.5|||ANOVA|||||0.5|-0.4|0.9022
71112183|NCT04855240|141731184|SUPERIORITY||LSM difference|0.3|STANDARD_ERROR_OF_MEAN|0.23||0.245|TWO_SIDED|95.0|-0.2|0.7|||ANOVA|||||0.7|-0.2|0.2450
71112184|NCT04855240|141731185|SUPERIORITY||LSM difference|0.2|STANDARD_ERROR_OF_MEAN|0.4205||0.4205|TWO_SIDED|95.0|-0.2|0.6|||ANOVA|||||0.6|-0.2|0.4205
71112185|NCT04855240|141731185|SUPERIORITY||LSM difference|0.2|STANDARD_ERROR_OF_MEAN|0.21||0.4336|TWO_SIDED|95.0|-0.2|0.6|||ANOVA|||||0.6|-0.2|0.4336
71112186|NCT04855240|141731186|SUPERIORITY||LSM difference|0.2|STANDARD_ERROR_OF_MEAN|0.22||0.2718|TWO_SIDED|95.0|-0.2|0.7|||ANOVA|||||0.7|-0.2|0.2718
71112187|NCT04855240|141731186|SUPERIORITY||LSM difference|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1727|TWO_SIDED|95.0|-0.1|0.7|||ANOVA|||||0.7|-0.1|0.1727
71112188|NCT01539070|141731202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3|||<|0.05|TWO_SIDED|95.0|1.8|10.8|||Regression, Linear|All Regression models adjusted for clustering by clinic, child age, change in age, BMI z-score, maternal education and occupation, and season|The change in the average vegetable consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||10.8|1.8|<0.05
71112189|NCT01539070|141731202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|||<|0.05|TWO_SIDED|95.0|-13.6|10.3|||Regression, Linear||The change in the average fruit consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||10.3|-13.6|<0.05
71112190|NCT01539070|141731202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||<|0.05|TWO_SIDED|95.0|-5.4|6.5|||Regression, Linear||The change in the average water consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||6.5|-5.4|<0.05
71112191|NCT01539070|141731202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|||<|0.05|TWO_SIDED|95.0|-8.9|1.1|||Regression, Linear||The change in the average sweet snacks consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||1.1|-8.9|<0.05
71112192|NCT01539070|141731202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||<|0.05|TWO_SIDED|95.0|-0.5|1.1|||Regression, Linear||The change in the average fast food consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||1.1|-0.5|<0.05
71112193|NCT01539070|141731202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||<|0.05|TWO_SIDED|95.0|-0.5|0.0|||Regression, Linear||The change in the average savory snacks consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||0.0|-0.5|<0.05
71067432|NCT01028014|141643129|SUPERIORITY_OR_OTHER||||||>|0.05||||||P values comparing differences across groups, as well as within group changes, were all \>0.05.P-values were not adjusted for multiple testing; p\<0.05 was considered statistically significant.|Wilcoxon (Mann-Whitney)|||Using difference in EMG amplitude as primary outcome, assuming standard deviation of 6, we had greater than 80% power to detect a 10-microvolt change in urethral muscle activity with sample size of 9 participants per group. Due to non-normality and small sample sizes, non-parametric tests were used and data presented as median (IQR). Kruskal-Wallis p-values are reported to compare median scores across groups. Wilcoxon sign-test p-values are reported to evaluate 2-week change within groups.||||>0.05
71067433|NCT02016105|141643140|EQUIVALENCE|Adjusted response rates were estimated using a logistic regression model including treatment, body weight strata, region and prior systemic therapy. The 95% CI for the rate difference was derived based on the normal approximation and standard error computed using the delta method.To conclude equivalent efficacy, the 95% CI had to be entirely within the interval \[-18%, 18%\].|Risk Difference (RD)|1.8|STANDARD_ERROR_OF_MEAN|4.75|||TWO_SIDED|95.0|-7.46|11.15||||||||11.15|-7.46|
71112194|NCT01539070|141731202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.05|TWO_SIDED|95.0|-4.9|3.4|||Regression, Linear||The change in the average sugar-sweetened beverage consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||3.4|-4.9|<0.05
71112195|NCT01539070|141731202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|||<|0.05|TWO_SIDED|95.0|-8.4|4.1|||Regression, Linear||The change in the average added sugar in beverage consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||4.1|-8.4|<0.05
70852738|NCT01578850|141194338|SUPERIORITY_OR_OTHER||Difference in proportions|16.0||||0.005|TWO_SIDED|95.0|5.96|26.02|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 70: Week 52||26.02|5.96|0.005
71112196|NCT01539070|141731203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.8|||<|0.05|TWO_SIDED|95.0|-29.1|5.5|||Regression, Linear|All Regression models adjusted for clustering by clinic, child age, change in age, BMI z-score, maternal education and occupation, and season|The change in mean physical activity between the baseline measurement and 3 months, the intervention group compared with the control group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI) are reported.||5.5|-29.1|<0.05
71112197|NCT01539070|141731203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||<|0.05|TWO_SIDED|95.0|-0.2|0.5|||Regression, Linear||The change in mean sleep time between the baseline measurement and 3 months, the intervention group compared with the control group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||0.5|-0.2|<0.05
71112198|NCT01539070|141731203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|||<|0.05|TWO_SIDED|95.0|-4.4|1.1|||Regression, Linear||The change in mean screen time between the baseline measurement and 3 months, the intervention group compared with the control group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||1.1|-4.4|<0.05
71112199|NCT01539070|141731205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|||<|0.05|TWO_SIDED|95.0|-0.04|0.35|||Regression, Linear|||In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||0.35|-0.04|<0.05
71112200|NCT02998671|141731206|SUPERIORITY|Comparison at end of Period 1 (P1): CJM112 versus Placebo.|Ratio of geometric means|1.18|||||TWO_SIDED|90.0|0.79|1.81|||Bayesian model for repeated measurements||"Ratio of Geometric Means (CJM112 / Placebo) calculated. A value \> 1 indicates a higher number of lesion counts in the CJM112 group.~Bayesian analysis. The credible interval was calculated and presented under confidence interval."|||1.81|0.79|
71112201|NCT02998671|141731206|SUPERIORITY|Comparison at end of Period 1 (P1): CJM112 versus Placebo.|Ratio of geometric means|1.1|||||TWO_SIDED|90.0|0.66|1.8|||Bayesian model for repeated measurements||"Ratio of Geometric Means (CJM112 / Placebo) calculated. A value \> 1 indicates a higher number of lesion counts in the CJM112 group.~Bayesian analysis. The credible interval was calculated and presented under confidence interval."|||1.80|0.66|
70852739|NCT01578850|141194338|SUPERIORITY_OR_OTHER||Difference in proportions|-0.3||||0.921|TWO_SIDED|95.0|-6.19|5.67|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 90: Week 24||5.67|-6.19|0.921
71112202|NCT03162796|141731239|SUPERIORITY||Difference in percentage|29.8|||<|0.001|TWO_SIDED|95.0|18.6|41.1|||Cochran-Mantel-Haenszel|||||41.1|18.6|< 0.001
71112203|NCT03162796|141731239|SUPERIORITY||Difference in percentage|37.1|||<|0.001|TWO_SIDED|95.0|26.1|48.2|||Cochran-Mantel-Haenszel|||||48.2|26.1|< 0.001
71112204|NCT03162796|141731240|SUPERIORITY||Least Square (LS) Mean Difference|-0.2483|||<|0.001|TWO_SIDED|95.0|-0.364|-0.1325|||ANCOVA|||||-0.1325|-0.3640|< 0.001
71112205|NCT03162796|141731240|SUPERIORITY||LS Mean difference|-0.3226|||<|0.001|TWO_SIDED|95.0|-0.4385|-0.2066|||ANCOVA|||||-0.2066|-0.4385|< 0.001
71112206|NCT03162796|141731241|SUPERIORITY||Difference in percentage|21.4|||<|0.001|TWO_SIDED|95.0|12.1|30.7||Nominal|Cochran-Mantel-Haenszel|||||30.7|12.1|< 0.001
71112207|NCT03162796|141731241|SUPERIORITY||Difference in percentage|27.2|||<|0.001|TWO_SIDED|95.0|17.6|36.8||Nominal|Cochran-Mantel-Haenszel|||||36.8|17.6|< 0.001
71112208|NCT03162796|141731242|SUPERIORITY||Difference in percentage|42.0|||<|0.001|TWO_SIDED|95.0|28.9|55.1|||Cochran-Mantel-Haenszel|||||55.1|28.9|< 0.001
71112209|NCT03162796|141731242|SUPERIORITY||Difference in percentage|60.0|||<|0.001|TWO_SIDED|95.0|48.3|71.8|||Cochran-Mantel-Haenszel|||||71.8|48.3|< 0.001
71112210|NCT03162796|141731243|SUPERIORITY||Difference in percentage|26.7|||<|0.001|TWO_SIDED|95.0|15.3|38.1||Nominal|Cochran-Mantel-Haenszel|||||38.1|15.3|< 0.001
71112211|NCT03162796|141731243|SUPERIORITY||Difference in percentage|34.8|||<|0.001|TWO_SIDED|95.0|23.5|46.0||Nominal|Cochran-Mantel-Haenszel|||||46.0|23.5|< 0.001
71112212|NCT03162796|141731244|SUPERIORITY||LS Mean difference|-0.73|||<|0.001||95.0|-0.98|-0.48||Nominal|ANCOVA|||||-0.48|-0.98|< 0.001
71112213|NCT03162796|141731244|SUPERIORITY||LS Mean difference|-0.91|||<|0.001||95.0|-1.16|-0.66||Nominal|ANCOVA|||||-0.66|-1.16|< 0.001
71112214|NCT03162796|141731245|SUPERIORITY||Difference in percentage|6.4||||0.069|TWO_SIDED|95.0|-0.3|13.1|||Cochran-Mantel-Haenszel|||||13.1|-0.3|0.069
71112215|NCT03162796|141731245|SUPERIORITY||Difference in percentage|14.8|||<|0.001|TWO_SIDED|95.0|6.9|22.7|||Cochran-Mantel-Haenszel|||||22.7|6.9|< 0.001
71112216|NCT03162796|141731246|SUPERIORITY||Difference in percentage|10.2||||0.036|TWO_SIDED|95.0|1.0|19.3||Nominal|Cochran-Mantel-Haenszel|||||19.3|1.0|0.036
71112217|NCT03162796|141731246|SUPERIORITY||Difference in percentage|13.9||||0.006|TWO_SIDED|95.0|4.4|23.4||Nominal|Cochran-Mantel-Haenszel|||||23.4|4.4|0.006
71112218|NCT03162796|141731247|SUPERIORITY||LS Mean difference|4.14|||<|0.001|TWO_SIDED|95.0|2.42|5.85|||ANCOVA|||||5.85|2.42|< 0.001
70852740|NCT01578850|141194338|SUPERIORITY_OR_OTHER||Difference in proportions|3.3||||0.41|TWO_SIDED|95.0|-2.19|8.86|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 90: Week 28||8.86|-2.19|0.410
71067434|NCT02016105|141643141|EQUIVALENCE|"LS means, SE and 95% CI were estimated by a Mixed Model Repeated Measures (MMRM) model with treatment, visit, treatment-by-visit interaction, body weight strata, region and prior systemic therapy, as fixed factors and baseline PASI score as covariate.~Therapeutic equivalence in terms of the % change from baseline in PASI score was to be determined if the 95% CI for the difference between GP2017 and Humira treatment was contained within the interval \[-15%; 15%\]."|LS means difference|0.8|STANDARD_ERROR_OF_MEAN|2.03|||TWO_SIDED|95.0|-3.15|4.84||||||||4.84|-3.15|
71067435|NCT02016105|141643142|EQUIVALENCE|LSM, SE and 95% CI were estimated using an ANCOVA model with treatment, body weight strata, region and prior systemic therapy as fixed effects and baseline PASI score as covariate. Therapeutic equivalence in terms of the % change from baseline in PASI score was to be determined if the 95% CI for the difference between GP2017 and Humira was contained within the interval \[-15%; 15%\].|LS means difference|1.2|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|-2.78|5.08||||||||5.08|-2.78|
71067436|NCT02751450|141643168|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.15|-0.882|||ANCOVA|Change from baseline in Schiff Sensitivity Score as response and treatment as a factor and baseline Schiff as a covariate|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|All statistical analyses were conducted under the null hypothesis (H0) of no difference between treatments versus the alternate hypothesis (H1) of a difference between treatments.||-0.882|-1.150|<0.0001
71067437|NCT01290679|141643172|SUPERIORITY_OR_OTHER||Difference in proportions of SVR12|32.2|||<|0.001|TWO_SIDED|95.0|23.3|41.2|||Cochran-Mantel-Haenszel|||The null hypothesis is there is no difference in proportions of SVR12 between the treatment groups.||41.2|23.3|<0.001
71067438|NCT01290679|141643173|SUPERIORITY_OR_OTHER||Difference in proportions of SVRW72|29.3|||<|0.001|TWO_SIDED|95.0|20.2|38.5|||Cochran-Mantel-Haenszel|||The null hypothesis is there is no difference in proportions of SVRW72 between the treatment groups.||38.5|20.2|<0.001
71067439|NCT01290679|141643174|SUPERIORITY_OR_OTHER||Difference in proportions of SVR24|31.5|||<|0.001|TWO_SIDED|95.0|22.5|40.5|||Cochran-Mantel-Haenszel|||The null hypothesis is there is no difference in proportions of SVR24 between the treatment groups.||40.5|22.5|<0.001
71067440|NCT01290679|141643175|SUPERIORITY_OR_OTHER||Difference in proportions of SVR4|32.3|||<|0.001|TWO_SIDED|95.0|23.5|41.0|||Cochran-Mantel-Haenszel|||The null hypothesis is there is no difference in proportions of SVR4 between the treatment groups.||41.0|23.5|<0.001
71067441|NCT01290679|141643202|SUPERIORITY_OR_OTHER||Mean differences|-16.776|STANDARD_ERROR_OF_MEAN|6.3081||0.008|TWO_SIDED|95.0|-29.1502|-4.4025|||Piecewise Linear Model|||Fatigue Severity Score AUC60||-4.4025|-29.1502|0.008
71067442|NCT01290679|141643202|SUPERIORITY_OR_OTHER||Mean differences|-18.837|STANDARD_ERROR_OF_MEAN|7.4715||0.012|TWO_SIDED|95.0|-33.4933|-4.1801|||Piecewise Linear Model|||Fatigue Severity Score AUC72||-4.1801|-33.4933|0.012
71067443|NCT01290679|141643203|SUPERIORITY_OR_OTHER||Mean differences|-282.16|STANDARD_ERROR_OF_MEAN|105.4927||0.008|TWO_SIDED|95.0|-489.1252|-75.1949|||Piecewise Linear Model|||Impairment in Work Productivity AUC60||-75.1949|-489.1252|0.008
71067444|NCT01290679|141643203|SUPERIORITY_OR_OTHER||Mean differences|-324.363|STANDARD_ERROR_OF_MEAN|124.026||0.009|TWO_SIDED|95.0|-567.708|-81.0182|||Piecewise Linear Model|||Impairment in Work Productivity AUC72||-81.0182|-567.7080|0.009
71067445|NCT01290679|141643204|SUPERIORITY_OR_OTHER||Mean Differences|-282.436|STANDARD_ERROR_OF_MEAN|104.9894||0.007|TWO_SIDED|95.0|-488.415|-76.4566|||Piecewise linear model|||Impairment in Daily Activities AUC60||-76.4566|-488.4150|0.007
71067446|NCT01290679|141643204|SUPERIORITY_OR_OTHER||Mean differences|-329.204|STANDARD_ERROR_OF_MEAN|123.408||0.008|TWO_SIDED|95.0|-571.3389|-87.0695|||Piecewise Linear Model|||Impairment in Daily Activities AUC72||-87.0695|-571.3389|0.008
71067447|NCT01290679|141643205|SUPERIORITY_OR_OTHER||Mean differences|-186.852|STANDARD_ERROR_OF_MEAN|121.4741||0.125|TWO_SIDED|95.0|-425.4109|51.7059|||Piecewise linear model|||Time Missed from Work AUC60||51.7059|-425.4109|0.125
71067448|NCT01290679|141643205|SUPERIORITY_OR_OTHER||Mean differences|-188.202|STANDARD_ERROR_OF_MEAN|141.1702||0.183|TWO_SIDED|95.0|-465.507|89.104|||Piecewise linear model|||Time Missed from Work AUC72||89.1040|-465.5070|0.183
71067449|NCT03660189|141643223|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||||||0.54
71067450|NCT03660189|141643223|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||||||0.44
71067451|NCT03660189|141643225|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71067452|NCT03660189|141643228|SUPERIORITY|||||||0.91|||||||Fisher Exact|||||||0.91
71067453|NCT03660189|141643229|SUPERIORITY|||||||0.45|||||||Fisher Exact|||||||0.45
71067454|NCT03660189|141643233|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71067455|NCT03660189|141643234|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71067456|NCT00994461|141643255|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Cochran-Mantel-Haenszel (CMH) test stratified by H. pylori status was employed for the comparison of celecoxib and loxoprofen with placebo. The multiplicity of test was not adjusted because these comparisons were for the secondary objective.|Cochran-Mantel-Haenszel|CMH test stratified by H. pylori status was employed. Continuous correction was used.||Hypothesis testing was conducted with significant p-value level of under 0.05.||||<0.0001
71067457|NCT02347813|141643264|OTHER||Mean Difference (Final Values)|0.5||||0.75|TWO_SIDED|95.0|||||ANOVA|||||||0.750
71067458|NCT01385137|141643266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.58|TWO_SIDED|95.0|-0.79|0.44|||Regression, Linear|||||0.44|-0.79|0.58
71067459|NCT01385137|141643268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.13||||0.42|TWO_SIDED|95.0|-7.3|3.04|||Regression, Linear|||||3.04|-7.30|0.42
71067460|NCT01385137|141643269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72||||0.77|TWO_SIDED|95.0|-4.17|5.6|||Regression, Linear|||||5.60|-4.17|0.77
71067461|NCT01385137|141643270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.14||||0.21|TWO_SIDED|95.0|-1.16|5.44|||Regression, Linear|||||5.44|-1.16|0.21
71067462|NCT02837731|141643271|SUPERIORITY||Mean Difference (Final Values)|-1.37||||0.021|TWO_SIDED|95.0|-2.53|0.21|||t-test, 2 sided|||||0.21|-2.53|0.021
71067463|NCT02837731|141643272|OTHER||Mean Difference (Final Values)|-0.124||||0.042|TWO_SIDED|95.0|-0.27|-0.01|||Fisher Exact||Converted Estimated Value of -12.4% to decimal value of -0.124.|||-0.01|-0.27|0.042
71067464|NCT02837731|141643273|OTHER||Mean Difference (Final Values)|-0.1642||||0.044|TWO_SIDED|95.0|-0.33|0.0|||Chi-squared||Converted Estimated Value of -16.42% to decimal value of -0.1642.|||0|-0.33|0.044
71067465|NCT02837731|141643274|OTHER||Mean Difference (Final Values)|-2.91||||0.113|TWO_SIDED|95.0|-6.67|0.85|||Fisher Exact|||||0.85|-6.67|0.113
70941798|NCT04748445|141383937|OTHER||Slope|0.6945|STANDARD_ERROR_OF_MEAN|7.972||0.3853|TWO_SIDED|90.0|-0.6265|2.015|||Mixed Models Analysis|||MM\_Formant 1 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||2.015|-0.6265|0.3853
71067466|NCT02837731|141643275|OTHER||Mean Difference (Final Values)|-72.43|||||TWO_SIDED|95.0|-154.08|9.22|||Wilcoxon (Mann-Whitney)|||||9.22|-154.08|
71067467|NCT02837731|141643276|OTHER||Mean Difference (Final Values)|-14.91||||0.426|TWO_SIDED|95.0|-52.5|22.68|||Wilcoxon (Mann-Whitney)|||||22.68|-52.50|0.426
71067468|NCT02837731|141643277|OTHER||Mean Difference (Final Values)|0.09||||0.453|TWO_SIDED|95.0|-0.34|0.52|||ANCOVA|||||0.52|-0.34|0.453
71067469|NCT02644668|141643293|SUPERIORITY||Least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.9086|TWO_SIDED|95.0|-0.13|0.11|||Mixed Models Analysis|||||0.11|-0.13|0.9086
71067470|NCT02644668|141643293|SUPERIORITY||Least squares mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.065||0.4361|TWO_SIDED|95.0|-0.18|0.08|||Mixed Models Analysis|||||0.08|-0.18|0.4361
71067471|NCT02644668|141643294|SUPERIORITY||Least squares mean difference|-2.94|STANDARD_ERROR_OF_MEAN|4.749||0.5382|TWO_SIDED|95.0|-12.43|6.55|||Mixed Models Analysis|||||6.55|-12.43|0.5382
71067472|NCT02644668|141643294|SUPERIORITY||Least squares mean difference|0.99|STANDARD_ERROR_OF_MEAN|5.099||0.8464|TWO_SIDED|95.0|-9.19|11.18|||Mixed Models Analysis|||||11.18|-9.19|0.8464
71067473|NCT02644668|141643295|SUPERIORITY||Least squares mean difference|11.69|STANDARD_ERROR_OF_MEAN|5.506||0.0378|TWO_SIDED|95.0|0.68|22.7|||Mixed Models Analysis|||||22.70|0.68|0.0378
71067474|NCT02644668|141643295|SUPERIORITY||Least squares mean difference|13.15|STANDARD_ERROR_OF_MEAN|5.913||0.0298|TWO_SIDED|95.0|1.33|24.97|||Mixed Models Analysis|||||24.97|1.33|0.0298
71067475|NCT02644668|141643296|SUPERIORITY||Least squares mean difference|-4.59|STANDARD_ERROR_OF_MEAN|7.56||0.5461|TWO_SIDED|95.0|-19.69|10.52|||Mixed Models Analysis|||||10.52|-19.69|0.5461
71067476|NCT02644668|141643296|SUPERIORITY||Least squares mean difference|-15.23|STANDARD_ERROR_OF_MEAN|8.175||0.0672|TWO_SIDED|95.0|-31.56|1.11|||Mixed Models Analysis|||||1.11|-31.56|0.0672
71067477|NCT02644668|141643297|SUPERIORITY||Least squares mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.928||0.6849|TWO_SIDED|95.0|-2.23|1.48|||Mixed Models Analysis|||||1.48|-2.23|0.6849
71067478|NCT02644668|141643297|SUPERIORITY||Least squares mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.98||0.3091|TWO_SIDED|95.0|-2.96|0.95|||Mixed Models Analysis|||||0.95|-2.96|0.3091
71067479|NCT02644668|141643298|SUPERIORITY||Least squares mean difference|0.61|STANDARD_ERROR_OF_MEAN|0.571||0.2878|TWO_SIDED|95.0|-0.53|1.75|||Mixed Models Analysis|||||1.75|-0.53|0.2878
71067480|NCT02644668|141643298|SUPERIORITY||Least squares mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.616||0.8512|TWO_SIDED|95.0|-1.34|1.11|||Mixed Models Analysis|||||1.11|-1.34|0.8512
71067481|NCT02644668|141643299|SUPERIORITY||Least squares mean difference|-0.78|STANDARD_ERROR_OF_MEAN|2.528||0.7612|TWO_SIDED|95.0|-6.08|4.52|||Mixed Models Analysis|||||4.52|-6.08|0.7612
71067482|NCT02644668|141643299|SUPERIORITY||Least squares mean difference|-3.1|STANDARD_ERROR_OF_MEAN|3.231||0.3502|TWO_SIDED|95.0|-9.91|3.7|||Mixed Models Analysis|||||3.70|-9.91|0.3502
71067483|NCT02644668|141643300|SUPERIORITY||Least squares mean difference|7.72|STANDARD_ERROR_OF_MEAN|10.484||0.4684|TWO_SIDED|95.0|-13.86|29.3|||Mixed Models Analysis|||||29.30|-13.86|0.4684
71067484|NCT02644668|141643300|SUPERIORITY||Least squares mean difference|24.89|STANDARD_ERROR_OF_MEAN|12.55||0.0584|TWO_SIDED|95.0|-0.95|50.74|||Mixed Models Analysis|||||50.74|-0.95|0.0584
71067485|NCT02644668|141643301|SUPERIORITY||Odds Ratio (OR)|0.43||||0.1686|TWO_SIDED|95.0|0.13|1.43|||Regression, Logistic|||Odds ratio of active vs placebo comparison of the patients' global assessment of better than pre-dose vs same or worse than pre-dose||1.43|0.13|0.1686
71067486|NCT02644668|141643301|SUPERIORITY||Odds Ratio (OR)|0.67||||0.5259|TWO_SIDED|95.0|0.2|2.3|||Regression, Logistic|||Odds ratio of active vs placebo comparison of the patients' global assessment of better than pre-dose vs same or worse than pre-dose||2.30|0.20|0.5259
71067487|NCT02644668|141643302|SUPERIORITY||Odds Ratio (OR)|1.22||||0.7655|TWO_SIDED|95.0|0.34|4.4|||Regression, Logistic|||Odds ratio of active vs placebo comparison of the patients' global assessment of better than pre-dose vs same or worse than pre-dose||4.40|0.34|0.7655
71067488|NCT02644668|141643302|SUPERIORITY||Odds Ratio (OR)|1.61||||0.492|TWO_SIDED|95.0|0.41|6.25|||Regression, Logistic|||Odds ratio of active vs placebo comparison of the patients' global assessment of better than pre-dose vs same or worse than pre-dose||6.25|0.41|0.4920
71067489|NCT00789698|141643345|NON_INFERIORITY_OR_EQUIVALENCE|This is a non-inferiority analysis. Lurasidone will be declared as effective as quetiapine XR in preventing relapse if the upper bound of a 2-sided 95% confidence limit for the hazard ration of lurasidone vs. quetiapine is no greater than an equivalence hazard ratio margin of 1.93.|Hazard Ratio (HR)|0.728|||||TWO_SIDED|95.0|0.41|1.295||There is no hypothesis tested. Since this was a non-inferiority study, the upper bound of the 95% CI for the hazard ratio was compared to the pre-specified margin of 1.93 to demonstrate the non-inferiority of lurasidone compared to Quetiapine XR.|COX Proportional Hazards Model|||Comparison of time to relapse of psychotic symptoms between LUR-LUR and QXR-QXR as analyzed using the Cox proportional-hazards model.||1.295|0.410|
71067490|NCT00596817|141643349|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.01||||0.0035|TWO_SIDED|95.0|1.26|3.21|||Cox-model|Cox-model using an exact method to handle ties||||3.21|1.26|0.0035
71067491|NCT00596817|141643350|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.09||||0.001|TWO_SIDED|95.0|1.35|3.23||A nominal p-value is provided.|Cox-Model|||||3.23|1.35|0.0010
71067492|NCT00596817|141643351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|STANDARD_ERROR_OF_MEAN|0.66||0.002|TWO_SIDED|95.0|-3.36|-0.77||A nominal p-value is provided.|ANCOVA|||||-0.77|-3.36|0.0020
71067493|NCT00596817|141643352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31|STANDARD_ERROR_OF_MEAN|0.55||0.0171|TWO_SIDED|95.0|-2.39|-0.24||A nominal p-value is provided.|ANCOVA|||||-0.24|-2.39|0.0171
71067494|NCT00596817|141643353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.6||0.0612|TWO_SIDED|95.0|-2.3|0.05||A nominal p-value is provided.|ANCOVA|||||0.05|-2.30|0.0612
71067495|NCT00596817|141643354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.1||0.0002|TWO_SIDED|95.0|-0.57|-0.18||A nominal p-value is provided.|ANCOVA|||||-0.18|-0.57|0.0002
71067496|NCT00596817|141643355|SUPERIORITY_OR_OTHER||Difference|6.35||||0.025|TWO_SIDED|95.0|1.13|11.56||A nominal p-value is provided.|Fisher Exact|||||11.56|1.13|0.025
71067497|NCT00596817|141643356|SUPERIORITY_OR_OTHER||Difference|12.13||||0.002|TWO_SIDED|95.0|4.73|19.52||A nominal p-value is provided.|Fisher Exact|||||19.52|4.73|0.002
71067498|NCT00596817|141643357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.73||0.3642|TWO_SIDED|95.0|-2.12|0.78||A nominal p-value is provided.|ANCOVA|||||0.78|-2.12|0.3642
71067499|NCT01560234|141643444|SUPERIORITY_OR_OTHER||Slope|0.81|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|0.63|1.0|||Regression, Linear||AUC (nmol\*h/L) 5 to 30 μg|||1.00|0.63|
71067500|NCT01560234|141643445|SUPERIORITY_OR_OTHER||Slope|0.84|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|0.65|1.04|||Regression, Linear||AUC(0-t) (nmol\*h/L) 5 to 30 μg|||1.04|0.65|
71067501|NCT01560234|141643446|SUPERIORITY_OR_OTHER||Slope|0.95|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|90.0|0.87|1.04|||Regression, Linear||Cmax (nmol/L) 0.5 to 30 μg|||1.04|0.87|
71067502|NCT01560234|141643447|SUPERIORITY_OR_OTHER||Percentage of Placebo|99.75|||||TWO_SIDED|95.0|65.76|151.32|||ANCOVA||Cohort 1/0.15 ug vs Placebo|24 hour Plasma||151.32|65.76|
71067503|NCT01560234|141643447|SUPERIORITY_OR_OTHER||Percentage of Placebo|92.99|||||TWO_SIDED|95.0|61.21|141.27|||ANCOVA||Cohort 2/1.5ug vs Placebo|24 hour Plasma||141.27|61.21|
71067504|NCT01560234|141643447|SUPERIORITY_OR_OTHER||Percentage of Placebo|145.83|||||TWO_SIDED|95.0|96.11|221.28|||ANCOVA||Cohort 4/5 ug vs Placebo|24 hour Plasma||221.28|96.11|
71067505|NCT01560234|141643447|SUPERIORITY_OR_OTHER||Percentage of Placebo|106.23|||||TWO_SIDED|95.0|66.42|169.93|||ANCOVA||Cohort 3/1.5 ug vs Placebo|24 hour Plasma||169.93|66.42|
71067506|NCT01560234|141643447|SUPERIORITY_OR_OTHER||Percentage of Placebo|223.76||||||95.0|144.98|345.35|||ANCOVA||Cohort 5/15 μg vs Placebo|24 hour plasma||345.35|144.98|
71067507|NCT01560234|141643447|SUPERIORITY_OR_OTHER||Percentage of Placebo|228.23|||||TWO_SIDED|95.0|150.36|346.41|||ANCOVA||Cohort 7/15 μg vs Placebo|24 hour plasma||346.41|150.36|
71067508|NCT01560234|141643447|SUPERIORITY_OR_OTHER||Percentage of Placebo|684.03|||||TWO_SIDED|95.0|495.31|944.65|||ANCOVA||Cohort 6 and 8/30 μg vs Placebo|24 hour plasma||944.65|495.31|
71067509|NCT01560234|141643448|SUPERIORITY_OR_OTHER||Percentage of Placebo|95.81|||||TWO_SIDED|95.0|72.7|126.28|||ANCOVA||Cohort 1/0.15 ug vs Placebo|48 hour plasma||126.28|72.70|
71067510|NCT01560234|141643448|SUPERIORITY_OR_OTHER||Percentage of Placebo|91.72|||||TWO_SIDED|95.0|69.53|121.0|||ANCOVA||Cohort 2/0.5 ug vs Placebo|48 hour plasma||121.00|69.53|
71067511|NCT01560234|141643448|SUPERIORITY_OR_OTHER||Percentage of Placebo|112.34|||||TWO_SIDED|95.0|82.3|153.35|||ANCOVA||Cohort 3/1.5 ug vs Placebo|48 hour Plasma||153.35|82.30|
71067512|NCT01560234|141643448|SUPERIORITY_OR_OTHER||Percentage of Placebo|120.0|||||TWO_SIDED|95.0|91.04|158.18|||ANCOVA||Cohort 4/5 ug vs Placebo|48 hour plasma||158.18|91.04|
71067513|NCT01560234|141643448|SUPERIORITY_OR_OTHER||Percentage of Placebo|102.67|||||TWO_SIDED|95.0|77.02|136.87|||ANCOVA||Cohort 5/15 ug vs Placebo|48 hour placebo||136.87|77.02|
71067514|NCT01560234|141643448|SUPERIORITY_OR_OTHER||Percentage of Placebo|146.86|||||TWO_SIDED|95.0|111.39|193.62|||ANCOVA||Cohort 7/15 ug vs Placebo|48 hour plasma||193.62|111.39|
71067515|NCT01560234|141643448|SUPERIORITY_OR_OTHER||Percentage of Placebo|240.04|||||TWO_SIDED|95.0|193.82|297.28|||ANCOVA||Cohort 6 and 8/30 ug|48 hour plasma||297.28|193.82|
71067516|NCT01560234|141643450|SUPERIORITY_OR_OTHER||Comparison of Placebo|114.87|||||TWO_SIDED|95.0|34.83|378.78|||ANCOVA||Cohort 1/0.15 ug vs Placebo|24 hour Sputum||378.78|34.83|
71067517|NCT01560234|141643450|SUPERIORITY_OR_OTHER||Comparison of Placebo|81.89|||||TWO_SIDED|95.0|24.96|268.7|||ANCOVA||Cohort 2/0.5 ug vs Placebo|24 hour Sputum||268.70|24.96|
71067518|NCT01560234|141643450|SUPERIORITY_OR_OTHER||Comparison of Placebo|81.55|||||TWO_SIDED|95.0|20.63|322.42|||ANCOVA||Cohort 3/1.5 ug vs Placebo|24 hour Sputum||322.42|20.63|
71067519|NCT01560234|141643450|SUPERIORITY_OR_OTHER||Comparison of Placebo|304.37|||||TWO_SIDED|95.0|76.61|1209.33|||ANCOVA||Cohort 4/5 ug vs Placebo|24 hour Sputum||1209.33|76.61|
71067520|NCT01560234|141643450|SUPERIORITY_OR_OTHER||Comparison of Placebo|193.8|||||TWO_SIDED|95.0|59.01|636.49|||ANCOVA||Cohort 5/15 μg vs Placebo|24 hour Sputum||636.49|59.01|
71067521|NCT01560234|141643450|SUPERIORITY_OR_OTHER||Comparison of Placebo|467.96|||||TWO_SIDED|95.0|142.77|1533.92|||ANCOVA||Cohort 7/15 μg vs Placebo|24 hour Sputum||1533.92|142.77|
71067522|NCT01560234|141643450|SUPERIORITY_OR_OTHER||Comparison of Placebo|1087.35|||||TWO_SIDED|95.0|317.19|3727.57|||ANCOVA||Cohort 6 and 8/30 μg vs Placebo|24 hour Sputum||3727.57|317.19|
71067523|NCT00648115|141643452|SUPERIORITY_OR_OTHER||Pearson chi square|7.3|||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
71067524|NCT01073605|141643454|SUPERIORITY_OR_OTHER|||||||0.02922|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||||||0.02922
70938665|NCT01767376|141377796|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group) for GMC ratios of antibodies against the pertactin (PRN) antigen, being greater than or equal to (≥) the predefined limit of 0.67.|Adjusted GMC ratio|0.72|||||TWO_SIDED|95.0|0.59|0.88|||ANCOVA|||To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) with respect to geometric mean concentrations (GMCs) of antibodies against pertactin (PRN), one month after Boostrix vaccination.||0.88|0.59|
70938666|NCT03745651|141377838|SUPERIORITY||Odds Ratio (OR)|8.84|||<|0.0001|TWO_SIDED|95.0|4.125|21.202||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||21.202|4.125|< 0.0001
70938667|NCT03745651|141377838|SUPERIORITY||Odds Ratio (OR)|15.8|||<|0.0001|TWO_SIDED|95.0|7.354|38.061||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||38.061|7.354|< 0.0001
71067525|NCT01073605|141643454|SUPERIORITY_OR_OTHER|||||||0.74299|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||||||0.74299
71067526|NCT01073605|141643454|SUPERIORITY_OR_OTHER|||||||0.00467|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||||||0.00467
71067527|NCT01073605|141643456|SUPERIORITY_OR_OTHER|||||||0.00125|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||1 year||||0.00125
71067528|NCT01073605|141643456|SUPERIORITY_OR_OTHER|||||||0.25995|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||1 year||||0.25995
71067529|NCT01073605|141643456|SUPERIORITY_OR_OTHER|||||||8e-05|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||1 year||||0.00008
71067530|NCT01073605|141643456|SUPERIORITY_OR_OTHER|||||||0.03273|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||2 years||||0.03273
71067531|NCT01073605|141643456|SUPERIORITY_OR_OTHER|||||||0.68581|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||2 years||||0.68581
71067532|NCT01073605|141643456|SUPERIORITY_OR_OTHER|||||||0.0053|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||2 years||||0.00530
71067533|NCT01073605|141643456|SUPERIORITY_OR_OTHER|||||||0.57556|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years||||0.57556
71067534|NCT01073605|141643456|SUPERIORITY_OR_OTHER|||||||0.63956|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years||||0.63956
70938668|NCT03745651|141377839|SUPERIORITY||Odds Ratio (OR)|6.84|||<|0.0001|TWO_SIDED|95.0|3.723|13.184||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||13.184|3.723|< 0.0001
71067535|NCT01073605|141643456|SUPERIORITY_OR_OTHER|||||||0.16421|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years||||0.16421
70938669|NCT03745651|141377839|SUPERIORITY||Odds Ratio (OR)|10.67|||<|0.0001|TWO_SIDED|95.0|5.775|20.732||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||20.732|5.775|< 0.0001
71067536|NCT01073605|141643460|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years||||0.0001
71067537|NCT01073605|141643460|SUPERIORITY_OR_OTHER|||||||0.58324|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years||||0.58324
70938670|NCT03745651|141377840|SUPERIORITY||Odds Ratio (OR)|4.17|||<|0.0001|TWO_SIDED|95.0|2.045|9.036||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||9.036|2.045|< 0.0001
71067538|NCT01073605|141643460|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years||||<0.0001
71067539|NCT01073605|141643465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.67||||0.0681|TWO_SIDED|95.0|-0.05|1.39||There is no adjustment for multiplicity of treatment comparisons.|ANCOVA|The Analysis of Covariance took into account the patient covariates age and gender.||||1.39|-0.05|0.0681
71112219|NCT03162796|141731247|SUPERIORITY||LS Mean difference|4.91|||<|0.001||95.0|3.19|6.63|||ANCOVA|||||6.63|3.19|< 0.001
71112220|NCT03162796|141731248|SUPERIORITY||Difference in percentage|13.0||||0.094|TWO_SIDED|95.0|-1.6|27.5||Nominal|Cochran-Mantel-Haenszel|||||27.5|-1.6|0.094
71112221|NCT03162796|141731248|SUPERIORITY||Difference in percentage|19.8||||0.013|TWO_SIDED|95.0|4.9|34.6||Nominal|Cochran-Mantel-Haenszel|||||34.6|4.9|0.013
71112222|NCT03162796|141731249|SUPERIORITY||LS Mean difference|-0.33||||0.185|TWO_SIDED|95.0|-0.83|0.16||Nominal|ANCOVA|||||0.16|-0.83|0.185
71112223|NCT03162796|141731249|SUPERIORITY||LS Mean difference|-0.74||||0.004|TWO_SIDED|95.0|-1.24|-0.24||Nominal|ANCOVA|||||-0.24|-1.24|0.004
71112224|NCT03162796|141731250|SUPERIORITY||LS Mean difference|0.83||||0.398|TWO_SIDED|95.0|-1.1|2.77||Nominal|ANCOVA|||||2.77|-1.10|0.398
71112225|NCT03162796|141731250|SUPERIORITY||LS Mean difference|1.23||||0.214|TWO_SIDED|95.0|-0.71|3.16||Nominal|ANCOVA|||||3.16|-0.71|0.214
71112226|NCT03162796|141731251|SUPERIORITY||Difference in percentage|16.6||||0.088|TWO_SIDED|95.0|-1.5|34.8||Nominal|Cochran-Mantel-Haenszel|||||34.8|-1.5|0.088
71112227|NCT03162796|141731251|SUPERIORITY||Difference in percentage|13.4||||0.212|TWO_SIDED|95.0|-6.9|33.7||Nominal|Cochran-Mantel-Haenszel|||||33.7|-6.9|0.212
71112228|NCT03162796|141731252|SUPERIORITY||LS Mean difference|-1.82||||0.121|TWO_SIDED|95.0|-4.12|0.49||Nominal|ANCOVA|||||0.49|-4.12|0.121
71112229|NCT03162796|141731252|SUPERIORITY||LS Mean difference|-1.53||||0.225|TWO_SIDED|95.0|-4.0|0.95||Nominal|ANCOVA|||||0.95|-4.00|0.225
70852741|NCT01578850|141194338|SUPERIORITY_OR_OTHER||Difference in proportions|6.4||||0.073|TWO_SIDED|95.0|0.41|12.48|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 90: Week 36||12.48|0.41|0.073
70852742|NCT01578850|141194338|SUPERIORITY_OR_OTHER||Difference in proportions|4.6||||0.219|TWO_SIDED|95.0|-0.97|10.08|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 90: Week 44||10.08|-0.97|0.219
71112230|NCT02473471|141731339|OTHER|The sample size was calculated based on a type I error frequency of 5%. According to the power analysis and assuming a large effect size difference between groups (effect size= 0.8), the power analysis yielded 28 subjects per group at a conventional alpha level (p = 0.05) and desired power (1 - β) of 0.90||||||0.77|||||||t-test, 2 sided|||||||0.77
71112231|NCT02473471|141731340|OTHER|||||||0.5|||||||t-test, 2 sided|||||||0.50
71112232|NCT02473471|141731341|OTHER|||||||0.76|||||||t-test, 2 sided|||||||0.76
70852743|NCT01578850|141194338|SUPERIORITY_OR_OTHER||Difference in proportions|5.9||||0.196|TWO_SIDED|95.0|-0.6|12.4|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 90: Week 52||12.40|-0.60|0.196
71112233|NCT02473471|141731342|OTHER|||||||0.56|||||||t-test, 2 sided|||||||0.56
71112234|NCT02473471|141731343|OTHER|||||||0.88|||||||t-test, 2 sided|||||||0.88
71112235|NCT02473471|141731344|OTHER|||||||0.74||||||There was no significant difference in tooth movement between control and MOP sides from baseline to 1st, 2nd and 3rd months. P Value \< 0.05 was considered statistically significant.|t-test, 2 sided|||||||0.74
71112236|NCT02473471|141731345|OTHER|||||||0.59|||||||t-test, 2 sided|||Root length at baseline.||||0.59
71112237|NCT02473471|141731345|OTHER|||||||0.48|||||||t-test, 2 sided|||Root length at 3 months||||0.48
71112238|NCT02473471|141731346|OTHER|||||||0.388|||||||t-test, 2 sided|||Immediate after intervention||||0.388
71112239|NCT02473471|141731346|OTHER|||||||0.092|||||||t-test, 2 sided|||1 hour after intervention||||0.092
71112240|NCT02473471|141731346|OTHER|||||||0.1|||||||t-test, 2 sided|||12 hour after intervention||||0.100
71112241|NCT02473471|141731346|OTHER|||||||0.302|||||||t-test, 2 sided|||Day 1 after intervention||||0.302
70852744|NCT01578850|141194340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.062|TWO_SIDED|95.0|-1.84|0.05|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Tender Joint Count: Week 28||0.05|-1.84|0.062
71112242|NCT02473471|141731346|OTHER|||||||0.582|||||||t-test, 2 sided|||Day 3 after intervention||||0.582
71112243|NCT02473471|141731346|OTHER|||||||0.743|||||||t-test, 2 sided|||Day 5 after intervention||||0.743
71112244|NCT02473471|141731346|OTHER|||||||0.809|||||||t-test, 2 sided|||Day 7 after intervention||||0.809
71112245|NCT02473471|141731347|OTHER|||||||0.09|||||||t-test, 2 sided|||Day 1||||0.09
71112246|NCT02473471|141731347|OTHER|||||||0.29|||||||t-test, 2 sided|||Day 3||||0.29
71112247|NCT02473471|141731347|OTHER|||||||0.57|||||||t-test, 2 sided|||Day 5||||0.57
71112248|NCT02473471|141731347|OTHER|||||||0.82|||||||t-test, 2 sided|||Day 7||||0.82
71112249|NCT02473471|141731348|OTHER|||||||0.27|||||||t-test, 2 sided|||Day 1||||0.27
71112250|NCT02473471|141731348|OTHER|||||||0.37|||||||t-test, 2 sided|||Day 3||||0.37
71112251|NCT02473471|141731348|OTHER|||||||0.33|||||||t-test, 2 sided|||Day 5||||0.33
71112252|NCT02473471|141731348|OTHER||||||>|0.05|||||||t-test, 2 sided|||Day 7||||> 0.05
71112253|NCT02473471|141731349|OTHER|||||||0.05|||||||t-test, 2 sided|||Day 1||||0.05
71112254|NCT02473471|141731349|OTHER|||||||0.47|||||||t-test, 2 sided|||Day 3||||0.47
71112255|NCT02473471|141731349|OTHER|||||||0.09|||||||t-test, 2 sided|||Day 5||||0.09
71112256|NCT02473471|141731349|OTHER|||||||0.16|||||||t-test, 2 sided|||||||0.16
71112257|NCT02473471|141731350|OTHER|||||||0.18|||||||t-test, 2 sided|||Day 1||||0.18
71112258|NCT02473471|141731350|OTHER|||||||0.57|||||||t-test, 2 sided|||Day 3||||0.57
71112259|NCT02473471|141731350|OTHER|||||||0.3|||||||t-test, 2 sided|||Day 5||||0.30
71112260|NCT02473471|141731350|OTHER|||||||0.56|||||||t-test, 2 sided|||Day 7||||0.56
71112261|NCT02473471|141731351|OTHER||||||<|0.05|||||||Descriptive statistics|||||||< 0.05
71112262|NCT01181804|141731363|NON_INFERIORITY_OR_EQUIVALENCE|Comparison of boceprevir tablet versus capsule used a mixed-effects model with fixed effects for formulation, sequence, and period, and a random effect for participant within sequence. The geometric mean ratio (GMR) of boceprevir tablet to boceprevir capsule is presented with two-sided 90% CIs. Equivalence of formulations was signified by the GMR falling within prespecified bioequivalence bounds.|Least Squares Geometric Mean Ratio|1.11|||||TWO_SIDED|90.0|1.07|1.15|||ANOVA|||||1.15|1.07|
71067540|NCT01073605|141643465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.8971|TWO_SIDED|95.0|-0.65|0.74||There is no adjustment for multiplicity of treatment comparisons.|ANCOVA|The Analysis of Covariance took into account the patient covariates age and gender.||||0.74|-0.65|0.8971
71067541|NCT01073605|141643465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63||||0.0583|TWO_SIDED|95.0|-1.27|0.02||There is no adjustment for multiplicity of treatment comparisons.|ANCOVA|The Analysis of Covariance took into account the patient covariates age and gender.||||0.02|-1.27|0.0583
71067542|NCT00083759|141643491|SUPERIORITY_OR_OTHER|||||||0.089||95.0|||||Cochran-Mantel-Haenszel|||||||0.089
71067543|NCT00083759|141643492|SUPERIORITY_OR_OTHER|||||||0.171||95.0|||||Cochran-Mantel-Haenszel|||||||0.171
71067544|NCT00083759|141643493|SUPERIORITY_OR_OTHER|||||||0.526||95.0|||||Cochran-Mantel-Haenszel|||||||0.526
71067545|NCT01057810|141643528|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.3667|TWO_SIDED|95.87|0.88|1.39|||Log Rank||Hazard ratio = ipilimumab over placebo|||1.39|0.88|0.3667
71067546|NCT01057810|141643529|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.55|0.8|||||HR = ipilimumab over placebo|||0.80|0.55|
71067547|NCT01057810|141643530|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.87|0.52|0.83|||||HR = Ipilimumab over placebo|||0.83|0.52|
71067548|NCT01057810|141643531|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.87|0.71|1.35|||||HR = Ipilimumab over placebo|||1.35|0.71|
71067549|NCT02088905|141643535|SUPERIORITY|||||||0.08||||||No adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Comparison of ECBI Problem Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||.080
71067550|NCT02088905|141643535|SUPERIORITY|||||||0.026||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of ECBI Intensity Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||.026
71112263|NCT01181804|141731364|NON_INFERIORITY_OR_EQUIVALENCE|Comparison of boceprevir tablet versus capsule used a mixed-effects model with fixed effects for formulation, sequence, and period, and a random effect for participant within sequence. The geometric mean ratio (GMR) of boceprevir tablet to boceprevir capsule is presented with two-sided 90% CIs. Equivalence of formulations was signified by the GMR falling within prespecified bioequivalence bounds.|Least Squares Geometric mean ratio|1.43|||||TWO_SIDED|90.0|1.32|1.54|||ANOVA|||||1.54|1.32|
71067551|NCT02088905|141643535|OTHER|Type III Tests of Fixed Effects|||||<|0.001||||||Mixed Model Analysis - Significance of Timepoint within the model in determining the effectiveness of assigned treatment.|Mixed Models Analysis|||Mixed Model Analysis of ECBI Intensity Scores, with variables of Timepoint, Treatment Assignment, and Timepoint\*Treatment Assignment interaction. Random intercept used.||||<.001
71067552|NCT02088905|141643535|OTHER|Type III Tests of Fixed Effects||||||0.182||||||Mixed Model Analysis - Significance of Treatment Assignment within the model in determining the effectiveness of assigned treatment.|Mixed Models Analysis|||Mixed Model Analysis of ECBI Intensity Scores, with variables of Timepoint, Treatment Assignment, and Timepoint\*Treatment Assignment interaction. Random intercept used.||||.182
71067553|NCT02088905|141643535|OTHER|Type III Tests of Fixed Effects||||||0.015||||||Mixed Model Analysis - Significance of Treatment Assignment and Timepoint Interaction Term within the model in determining the effectiveness of assigned treatment.|Mixed Models Analysis|||Mixed Model Analysis of ECBI Intensity Scores, with variables of Timepoint, Treatment Assignment, and Timepoint\*Treatment Assignment interaction. Random intercept used.||||.015
71067554|NCT02088905|141643536|SUPERIORITY|||||||0.203||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of PSI Parental Distress between Week 18 scores, 1 sided test for Treatment Group Superiority||||.203
71067555|NCT02088905|141643536|SUPERIORITY|||||||0.17||||||No adjustment for multiple comparisons|Wilcoxon (Mann-Whitney)|||Comparison of PSI Parent-Child Dysfunctional Interaction between Week 18 scores, 1 sided test for Treatment Group Superiority||||0.17
71067556|NCT02088905|141643536|SUPERIORITY|||||||0.308||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of PSI Difficult Child between Week 18 scores, 1 sided test for Treatment Group Superiority||||0.308
71067557|NCT02088905|141643536|SUPERIORITY|||||||0.413||||||No adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Comparison of PSI Total Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||.413
71067558|NCT02088905|141643538|SUPERIORITY|||||||0.271||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Total Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||0.271
71067559|NCT02088905|141643538|SUPERIORITY|||||||0.434||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Awareness Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||.434
71067560|NCT02088905|141643538|SUPERIORITY|||||||0.298||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Cognition Scores between Week 18 scores, 1 sided test for Treatment Group Superiority||||.298
71112264|NCT01181804|141731365|NON_INFERIORITY_OR_EQUIVALENCE|Comparison of boceprevir tablet versus capsule used a mixed-effects model with fixed effects for formulation, sequence, and period, and a random effect for participant within sequence. The geometric mean ratio (GMR) of boceprevir tablet to boceprevir capsule is presented with two-sided 90% CIs. Equivalence of formulations was signified by the GMR falling within prespecified bioequivalence bounds.|Least Squares Geometric mean ratio|1.1|||||TWO_SIDED|95.0|1.06|1.14|||ANOVA|||||1.14|1.06|
71112265|NCT01181804|141731366|NON_INFERIORITY_OR_EQUIVALENCE|Comparison of boceprevir tablet versus capsule used a mixed-effects model with fixed effects for formulation, sequence, and period, and a random effect for participant within sequence. The geometric mean ratio (GMR) of boceprevir tablet to boceprevir capsule is presented with two-sided 90% CIs. Equivalence of formulations was signified by the GMR falling within prespecified bioequivalence bounds.|Least Squares Geometric mean ratio|1.15|||||TWO_SIDED|90.0|1.09|1.21|||ANOVA|||||1.21|1.09|
71067561|NCT02088905|141643538|SUPERIORITY|||||||0.294||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Communication Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||.294
71112266|NCT03163134|141731372|OTHER|||||||0.017|||||||Chi-squared|||||||0.017
71112267|NCT03163134|141731373|OTHER|||||||0.577|||||||Chi-squared|||||||0.577
71112268|NCT02063984|141731374|SUPERIORITY||Odds Ratio (OR)|0.42|||||TWO_SIDED|95.0|0.11|1.56|||||Outcome was tested in a zero-inflated negative binomial (ZINB) model|CM+No WMT is the comparison condition||1.56|.11|
71112269|NCT02063984|141731375|SUPERIORITY||Ratio of means|1.56|||||TWO_SIDED|95.0|0.79|3.07|||||Outcome was tested in a zero-inflated negative binomial (ZINB) model|CM+No WMT is the comparison condition||3.07|.79|
71067562|NCT02088905|141643538|SUPERIORITY|||||||0.441||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Motivation between Week 18 scores, 1 sided test for Treatment Group Superiority||||.441
71067563|NCT02088905|141643538|SUPERIORITY|||||||0.204||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Restricted and Repetitive Behavior Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||.204
71067564|NCT02088905|141643540|SUPERIORITY||||||<|0.001||||||No adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Comparison of DPICS Negative Skills between Week 18 scores, 1 sided test for Treatment Group Superiority||||<.001
71067565|NCT02088905|141643540|SUPERIORITY||||||<|0.001||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of DPICS Positive Skills between Week 18 scores, 1 sided test for Treatment Group Superiority. Data transformed using a square root transformation.||||<.001
71067566|NCT04606394|141643543|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.33|TWO_SIDED||||||Chi-squared|||Data outcome reported was the number and percentage of subject test days with DPI Failure in subjects in suboptimal PIF (\<60 L/min) versus normal PIF subjects. Statistical analysis performed was a comparison between rates of DPI Failure in the 2 groups.||||0.33
71067567|NCT04606394|141643544|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.04|TWO_SIDED||||||Chi-squared|||Data outcome reported was the number and percentage of subject test days with DPI Failure in subjects in suboptimal PIF (\<60 L/min) versus normal PIF subjects. Statistical analysis performed was a comparison between rates of DPI Failure in the 2 groups.||||0.04
71067568|NCT04481789|141643550|OTHER|Estimates of least squares mean difference of log-transformed PK parameters between treatments were obtained with their 2-sided 90%CIs for the difference. These estimates and limits were then back-transformed to obtain ratios of least squares geometric means. If the 90%CIs lay entirely within the limits of 0.80 to 1.25, this would provide evidence of no effect of edaravone on the PK of rosuvastatin, sildenafil, and furosemide (LS Mean Ratio: Rosuvastatin + Edaravone / Rosuvastatin Alone).|LS Mean Ratio|1.02|||||TWO_SIDED|90.0|0.97|1.08||||||PK parameters of rosuvastatin, sildenafil, and furosemide alone and in the presence of edaravone were analyzed for the assessments of effect on PK of rosuvastatin, sildenafil, and furosemide by edaravone.||1.08|0.97|
71067569|NCT04481789|141643550|OTHER|Estimates of least squares mean difference of log-transformed PK parameters between treatments were obtained with their 2-sided 90%CIs for the difference. These estimates and limits were then back-transformed to obtain ratios of least squares geometric means. If the 90%CIs lay entirely within the limits of 0.80 to 1.25, this would provide evidence of no effect of edaravone on the PK of rosuvastatin, sildenafil, and furosemide (LS Mean Ratio: Sildenafil + Edaravone / Sildenafil Alone).|LS Mean Ratio|0.93|||||TWO_SIDED|90.0|0.88|0.99||||||PK parameters of rosuvastatin, sildenafil, and furosemide alone and in the presence of edaravone were analyzed for the assessments of effect on PK of rosuvastatin, sildenafil, and furosemide by edaravone.||0.99|0.88|
71067570|NCT04481789|141643550|OTHER|Estimates of least squares mean difference of log-transformed PK parameters between treatments were obtained with their 2-sided 90%CIs for the difference. These estimates and limits were then back-transformed to obtain ratios of least squares geometric means. If the 90%CIs lay entirely within the limits of 0.80 to 1.25, this would provide evidence of no effect of edaravone on the PK of rosuvastatin, sildenafil, and furosemide (LS Mean Ratio: Furosemide + Edaravone / Furosemide Alone).|LS Mean Ratio|1.03|||||TWO_SIDED|90.0|0.98|1.09||||||PK parameters of rosuvastatin, sildenafil, and furosemide alone and in the presence of edaravone were analyzed for the assessments of effect on PK of rosuvastatin, sildenafil, and furosemide by edaravone.||1.09|0.98|
71067571|NCT04481789|141643551|OTHER|Estimates of least squares mean difference of log-transformed PK parameters between treatments were obtained with their 2-sided 90%CIs for the difference. These estimates and limits were then back-transformed to obtain ratios of least squares geometric means. If the 90%CIs lay entirely within the limits of 0.80 to 1.25, this would provide evidence of no effect of edaravone on the PK of rosuvastatin, sildenafil, and furosemide (LS Mean Ratio: Rosuvastatin + Edaravone / Rosuvastatin).|LS Mean Ratio|0.98|||||TWO_SIDED|90.0|0.91|1.06||||||PK parameters of rosuvastatin, sildenafil, and furosemide alone and in the presence of edaravone were analyzed for the assessments of effect on PK of rosuvastatin, sildenafil, and furosemide by edaravone.||1.06|0.91|
71067572|NCT04481789|141643551|OTHER|Estimates of least squares mean difference of log-transformed PK parameters between treatments were obtained with their 2-sided 90%CIs for the difference. These estimates and limits were then back-transformed to obtain ratios of least squares geometric means. If the 90%CIs lay entirely within the limits of 0.80 to 1.25, this would provide evidence of no effect of edaravone on the PK of rosuvastatin, sildenafil, and furosemide (LS Mean Ratio: Sildenafil + Edaravone / Sildenafil Alone).|LS Mean Ratio|0.94|||||TWO_SIDED|90.0|0.8|1.1||||||PK parameters of rosuvastatin, sildenafil, and furosemide alone and in the presence of edaravone were analyzed for the assessments of effect on PK of rosuvastatin, sildenafil, and furosemide by edaravone.||1.10|0.80|
71067573|NCT04481789|141643551|OTHER|Estimates of least squares mean difference of log-transformed PK parameters between treatments were obtained with their 2-sided 90%CIs for the difference. These estimates and limits were then back-transformed to obtain ratios of least squares geometric means. If the 90%CIs lay entirely within the limits of 0.80 to 1.25, this would provide evidence of no effect of edaravone on the PK of rosuvastatin, sildenafil, and furosemide (LS Mean Ratio: Furosemide + Edaravone / Furosemide Alone).|LS Mean Ratio|1.08|||||TWO_SIDED|90.0|0.96|1.23||||||PK parameters of rosuvastatin, sildenafil, and furosemide alone and in the presence of edaravone were analyzed for the assessments of effect on PK of rosuvastatin, sildenafil, and furosemide by edaravone.||1.23|0.96|
71067574|NCT04481789|141643566|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of 1 Hour After a High-fat Meal condition to the fasted state.|LS Mean Ratio|0.842|||||TWO_SIDED|90.0|0.697|1.017||||||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.017|0.697|
71067575|NCT04481789|141643566|OTHER|Estimated difference in least squares means and corresponding 90% CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of 4 Hours After a High-fat Meal condition to the fasted state.|LS Mean Ratio|0.737|||||TWO_SIDED|90.0|0.61|0.891||||||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||0.891|0.610|
71067576|NCT04481789|141643567|OTHER|Estimated difference in least squares means and corresponding 90% CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of 1 Hour After a High-fat Meal condition to the fasted state.|LS Mean Ratio|0.657|||||TWO_SIDED|90.0|0.379|1.137||||||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.137|0.379|
71067577|NCT04481789|141643567|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of 4 Hours After a High-fat Meal condition to the fasted state.|LS Mean Ratio|0.522|||||TWO_SIDED|90.0|0.301|0.903||||||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||0.903|0.301|
71067578|NCT03139578|141643586|NON_INFERIORITY|Non-inferiority margin of 0.625 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of 0.625, then non-inferiority of Test relative to Control was concluded.|Cumulative Odds Ratio|1.18|||||TWO_SIDED|95.0|0.46|3.06|||Generalized linear mixed model|Simulation-based adjustment was utilized to address the multiple comparisons of different base curves.|Cumulative odds ratio was calculated as Test over Control.|||3.06|0.46|
71067579|NCT03139578|141643586|NON_INFERIORITY|Non-inferiority margin of 0.625 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of 0.625, then non-inferiority of Test relative to Control was concluded.|Cumulative Odds Ratio|0.93|||||TWO_SIDED|95.0|0.34|2.52|||Generalized linear mixed model|Simulation-based adjustment was utilized to address the multiple comparisons of different base curves.|Cumulative odds ratio was calculated as Test over Control.|||2.52|0.34|
71067580|NCT03139578|141643587|EQUIVALENCE|Equivalence margin of 70% was used for no difference in lens power requirement.|Proportion (%)|93.8|||||TWO_SIDED|97.5|81.1|98.1|||Wilson Method||Lens power requirement difference was calculated as Test minus Control. Then the proportion of eyes with similar lens power requirements (no difference or difference within ±0.25D) was calculated.|||98.1|81.1|
71067581|NCT03139578|141643587|EQUIVALENCE|Equivalence margin of 70% was used for no difference in lens power requirement.|Proportion (%)|83.3|||||TWO_SIDED|97.5|68.3|92.1|||Wilson Method||Lens power requirement difference was calculated as Test minus Control. Then the proportion of eyes with similar lens power requirements (no difference or difference within ±0.25D) was calculated.|||92.1|68.3|
71067582|NCT03139578|141643587|EQUIVALENCE|Equivalence margin of 80% was used for the lens power requirement difference within ±0.25 D.|Proportion (%)|100.0|||||TWO_SIDED|97.5|90.5|100.0|||Wilson Method||Lens power requirement difference was calculated as Test minus Control. Then the proportion of eyes with similar lens power requirements (no difference or difference within ±0.25D) was calculated.|||100|90.5|
71067583|NCT03139578|141643587|EQUIVALENCE|Equivalence margin of 80% was used for the lens power requirement difference within ±0.25 D.|Proportion (%)|100.0|||||TWO_SIDED|97.5|90.5|100.0|||Wilson Method||Lens power requirement difference was calculated as Test minus Control. Then the proportion of eyes with similar lens power requirements (no difference or difference within ±0.25D) was calculated.|||100.0|90.5|
71067584|NCT03139578|141643588|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.2|||||TWO_SIDED|95.0|-0.3|0.7|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.7|-0.3|
71067585|NCT03139578|141643588|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.5|0.5|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.5|-0.5|
71067586|NCT03139578|141643589|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|-0.1|||||TWO_SIDED|95.0|-0.4|0.3|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.3|-0.4|
71067587|NCT03139578|141643589|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.2|0.5|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.5|-0.2|
71067588|NCT03139578|141643590|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.4|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.4|-0.1|
71067589|NCT03139578|141643590|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.2|0.3|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.3|-0.2|
70938671|NCT03745651|141377840|SUPERIORITY||Odds Ratio (OR)|5.8|||<|0.0001|TWO_SIDED|95.0|2.833|12.657||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||12.657|2.833|< 0.0001
70938672|NCT03745651|141377841|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8553|TWO_SIDED|95.0|0.598|2.094||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||2.094|0.598|0.8553
70938673|NCT03745651|141377841|SUPERIORITY||Odds Ratio (OR)|1.47||||0.2359|TWO_SIDED|95.0|0.805|2.741||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||2.741|0.805|0.2359
70938674|NCT03745651|141377842|SUPERIORITY||Odds Ratio (OR)|1.62||||0.1784|TWO_SIDED|95.0|0.827|3.342||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||3.342|0.827|0.1784
71067590|NCT03139578|141643591|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.5|0.5|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.5|-0.5|
71067591|NCT03139578|141643591|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|-0.1|||||TWO_SIDED|95.0|-0.6|0.4|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.4|-0.6|
71067592|NCT03139578|141643592|NON_INFERIORITY|Non-inferiority margin of 0.1 was used. If the upper limit of 95% confidence interval was lower than a non-inferiority margin of 0.1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.002|||||TWO_SIDED|95.0|-0.009|0.012|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.012|-0.009|
71067593|NCT03139578|141643592|NON_INFERIORITY|Non-inferiority margin of 0.1 was used. If the upper limit of 95% confidence interval was lower than a non-inferiority margin of 0.1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|-0.001|||||TWO_SIDED|95.0|-0.012|0.009|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.009|-0.012|
71067594|NCT03793842|141643610|EQUIVALENCE|Equivalence margin 1 J/min||||||0.002|||||||t-test, 2 sided|||||||.002
71067595|NCT03793842|141643611|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.2
71067596|NCT03793842|141643612|EQUIVALENCE|Equivalence margin 1 cm H20|Mean Difference (Net)|0.05||||0.006|TWO_SIDED||||||t-test, 2 sided|||||||0.006
71067597|NCT03793842|141643613|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
71067598|NCT03793842|141643614|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||0.008
71067599|NCT01075256|141643711|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.1||||0.3628|TWO_SIDED|95.0|-6.7|2.46||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no diference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||2.46|-6.70|0.3628
71067600|NCT01075256|141643711|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.2||||0.9361|TWO_SIDED|95.0|-4.45|4.83||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||4.83|-4.45|0.9361
71067601|NCT01075256|141643711|SUPERIORITY_OR_OTHER||Adjusted Mean difference|2.3||||0.3257|TWO_SIDED|95.0|-2.31|6.92||No adustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||6.92|-2.31|0.3257
71112270|NCT02063984|141731376|SUPERIORITY||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.18|4.82||||||CM+No WMT is the comparison condition||4.82|.18|
71112271|NCT02063984|141731377|SUPERIORITY||Ratio of means|0.92|||||TWO_SIDED|95.0|0.33|2.54|||||Outcome was tested in a zero-inflated negative binomial (ZINB) model|CM+No WMT is the comparison condition||2.54|.33|
71112272|NCT02063984|141731378|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.45|2.45||||||Strategy 1 is the comparison condition||2.45|.45|
70938675|NCT03745651|141377842|SUPERIORITY||Odds Ratio (OR)|1.96||||0.0472|TWO_SIDED|95.0|1.007|4.0||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||4.000|1.007|0.0472
70938676|NCT03745651|141377852|SUPERIORITY||Least Squares Mean Difference|-31.91|STANDARD_ERROR_OF_MEAN|4.92|<|0.0001|TWO_SIDED|95.0|-41.57|-22.25|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 2||-22.25|-41.57|<0.0001
71067602|NCT01075256|141643712|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.0||||0.6674|TWO_SIDED|95.0|-5.73|3.68||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||3.68|-5.73|0.6674
71112273|NCT02063984|141731378|SUPERIORITY||Odds Ratio (OR)|2.29|||||TWO_SIDED|95.0|0.84|6.2||||||Strategy 1 is the comparison condition||6.20|.84|
71112274|NCT02063984|141731378|SUPERIORITY||Odds Ratio (OR)|0.51|||||TWO_SIDED|95.0|0.23|1.13||||||Strategy 1 is the comparison condition||1.13|.23|
70938677|NCT03745651|141377852|SUPERIORITY||Least Squares Mean Difference|-35.13|STANDARD_ERROR_OF_MEAN|4.93|<|0.0001|TWO_SIDED|95.0|-44.81|-25.44|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 2||-25.44|-44.81|<0.0001
71067603|NCT01075256|141643712|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0||||0.9888|TWO_SIDED|95.0|-4.74|4.81||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is the high concentration minus placebo such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||4.81|-4.74|0.9888
71067604|NCT01075256|141643712|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.1||||0.6599|TWO_SIDED|95.0|-3.69|5.81||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||5.81|-3.69|0.6599
71067605|NCT01075256|141643713|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1||||0.9759|TWO_SIDED|95.0|-6.34|6.54||No adjustments for multiple comparisons|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||6.54|-6.34|0.9759
71067606|NCT01075256|141643713|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.5||||0.8903|TWO_SIDED|95.0|-6.97|6.06||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||6.06|-6.97|0.8903
71067607|NCT01075256|141643713|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.6||||0.8662|TWO_SIDED|95.0|-7.04|5.93||No adjustments for multiple comparisons|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.||5.93|-7.04|0.8662
71067608|NCT01075256|141643714|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.6||||0.8419|TWO_SIDED|95.0|-6.93|5.66||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||5.66|-6.93|0.8419
71067609|NCT01075256|141643714|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.3||||0.9147|TWO_SIDED|95.0|-6.03|6.72||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||6.72|-6.03|0.9147
71067610|NCT01075256|141643714|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.0||||0.76|TWO_SIDED|95.0|-5.36|7.33||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||7.33|-5.36|0.7600
71067611|NCT01075256|141643715|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.5||||0.9124|TWO_SIDED|95.0|-8.28|9.24||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||9.24|-8.28|0.9124
71112275|NCT02063984|141731379|SUPERIORITY||Ratio of means|1.21|||||TWO_SIDED|95.0|0.76|1.92||||||Strategy 1 is the comparison condition||1.92|.76|
71112276|NCT02063984|141731379|SUPERIORITY||Ratio of means|0.76|||||TWO_SIDED|95.0|0.49|1.18||||||Strategy 1 is the comparison condition||1.18|.49|
71112277|NCT02063984|141731379|SUPERIORITY||Ratio of means|1.33|||||TWO_SIDED|95.0|0.83|2.15||||||Strategy 1 is the comparison condition||2.15|.83|
71112278|NCT01158820|141731385|OTHER|No data available for power analysis|Mean Difference (Net)|0.028|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71112279|NCT01158820|141731386|SUPERIORITY||Mean Difference (Final Values)|43.75|||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||units are µg|See reference power analysis||||<0.01
71112280|NCT01158820|141731387|SUPERIORITY||Median Difference (Final Values)|1.75||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||units are mg|See reference for power analysis||||0.01
70938678|NCT03745651|141377852|SUPERIORITY||Least Squares Mean Difference|-44.56|STANDARD_ERROR_OF_MEAN|4.4|<|0.0001|TWO_SIDED|95.0|-53.19|-35.92|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 4||-35.92|-53.19|<0.0001
70938679|NCT03745651|141377852|SUPERIORITY||Least Squares Mean Difference|-45.91|STANDARD_ERROR_OF_MEAN|4.4|<|0.0001|TWO_SIDED|95.0|-54.55|-37.26|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 4||-37.26|-54.55|<0.0001
71112281|NCT00005947|141731415|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||0.052||95.0|0.99|2.11|||Log Rank||Obtained from a Cox proportional hazards model with treatment group as the independent variable \[placebo/sipuleucel-T\].|||2.11|0.99|0.052
70938680|NCT03745651|141377852|SUPERIORITY||Least Squares Mean Difference|-44.53|STANDARD_ERROR_OF_MEAN|4.35|<|0.0001|TWO_SIDED|95.0|-53.08|-35.98|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 8||-35.98|-53.08|<0.0001
71067612|NCT01075256|141643715|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.5||||0.9083|TWO_SIDED|95.0|-9.13|8.14||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level||8.14|-9.13|0.9083
71067613|NCT01075256|141643715|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.0||||0.8231|TWO_SIDED|95.0|-9.73|7.77||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||7.77|-9.73|0.8231
71067614|NCT01075256|141643716|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.4||||0.5946|TWO_SIDED|95.0|-9.32|16.09||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||16.09|-9.32|0.5946
71067615|NCT01075256|141643716|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0||||0.9944|TWO_SIDED|95.0|-12.51|12.6||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||12.60|-12.51|0.9944
71067616|NCT01075256|141643716|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.3||||0.5998|TWO_SIDED|95.0|-16.06|9.38||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||9.38|-16.06|0.5998
71067617|NCT01075256|141643717|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.2||||0.7952|TWO_SIDED|95.0|-10.51|8.09||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||8.09|-10.51|0.7952
71067618|NCT01075256|141643717|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.4||||0.601|TWO_SIDED|95.0|-11.56|6.76||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||6.76|-11.56|0.6010
71067619|NCT01075256|141643717|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.2||||0.7976|TWO_SIDED|95.0|-10.48|8.1||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||8.10|-10.48|0.7976
71067620|NCT01075256|141643718|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.7||||0.906|TWO_SIDED|95.0|-10.38|11.68||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||11.68|-10.38|0.9060
71067621|NCT01075256|141643718|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.7||||0.7575|TWO_SIDED|95.0|-12.63|9.25||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||9.25|-12.63|0.7575
71067622|NCT01075256|141643718|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.3||||0.6727|TWO_SIDED|95.0|-13.42|8.73||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||8.73|-13.42|0.6727
71112282|NCT00005947|141731415|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.052|TWO_SIDED|95.0|0.47|1.01|||Log Rank||Obtained from a Cox proportional hazards model with treatment group as the independent variable \[sipuleucel-T/placebo\]|||1.01|0.47|0.052
71067623|NCT02115581|141643720|SUPERIORITY_OR_OTHER|||||||0.267||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.267
71067624|NCT02115581|141643721|SUPERIORITY_OR_OTHER|||||||0.011|||||||Fisher Exact|||||||0.011
71067625|NCT00869622|141643760|SUPERIORITY_OR_OTHER|||||||0.0229|TWO_SIDED||||||Fisher Exact|||||||0.0229
71067626|NCT01515865|141643798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.8||||0.3145|TWO_SIDED|95.0|-37.6|9.8|||Fisher Exact|||||9.8|-37.6|0.3145
71067627|NCT01113385|141643802|SUPERIORITY_OR_OTHER|||||||0.009||||||p value reflects the difference in mean FSPF pre vs post galactose treatment.|t-test, 2 sided|||||||0.009
70938681|NCT03745651|141377852|SUPERIORITY||Least Squares Mean Difference|-46.0|STANDARD_ERROR_OF_MEAN|4.33|<|0.0001|TWO_SIDED|95.0|-54.51|-37.48|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 8||-37.48|-54.51|<0.0001
70938682|NCT03745651|141377853|SUPERIORITY||Least Squares Mean Difference|-39.4|STANDARD_ERROR_OF_MEAN|3.59|<|0.0001|TWO_SIDED|95.0|-46.48|-32.38|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent change from Baseline in SCORAD score at Week 8||-32.38|-46.48|<0.0001
70938683|NCT03745651|141377853|SUPERIORITY||Least Squares Mean Difference|-43.5|STANDARD_ERROR_OF_MEAN|3.56|<|0.0001|TWO_SIDED|95.0|-50.51|-36.53|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent change from Baseline in SCORAD score at Week 8||-36.53|-50.51|<0.0001
70938684|NCT03745651|141377854|SUPERIORITY||Least Squares Mean Difference|-1.52|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.02|-1.01|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 2||-1.01|-2.02|<0.0001
70938685|NCT03745651|141377854|SUPERIORITY||Least Squares Mean Difference|-1.74|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.24|-1.24|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 2||-1.24|-2.24|<0.0001
70938686|NCT03745651|141377854|SUPERIORITY||Least Squares Mean Difference|-1.79|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|-2.36|-1.23|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 4||-1.23|-2.36|<0.0001
70938687|NCT03745651|141377854|SUPERIORITY||Least Squares Mean Difference|-1.97|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|-2.53|-1.4|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 4||-1.40|-2.53|<0.0001
71067628|NCT05406479|141643837|NON_INFERIORITY|For the hypothesis testing of non-inferiority the confidence interval should be compared to the non-inferiority margin. More specifically, non-inferiority is established if the upper limit of a one-sided 95% confidence interval around the difference in means QTc 24 hours after treatment administration (BE-PEP - SDR-PEP) is below the non-inferiority limit of +10 ms. A two-sample t-test was used to compare the two groups, but the p-value returned should not be used to conclude non-inferiority.|Mean Difference (Final Values)|-0.193|||||TWO_SIDED|95.0|-5.146|4.76||||||Adults||4.76|-5.146|
71067629|NCT05406479|141643837|NON_INFERIORITY|For the hypothesis testing of non-inferiority the confidence interval should be compared to the non-inferiority margin. More specifically, non-inferiority is established if the upper limit of a one-sided 95% confidence interval around the difference in means QTc 24 hours after treatment administration (BE-PEP - SDR-PEP) is below the non-inferiority limit of +10 ms. A two-sample t-test was used to compare the two groups, but the p-value returned should not be used to conclude non-inferiority.|Mean Difference (Final Values)|10.556|||||TWO_SIDED|95.0|0.926|20.185||||||Adolescents (13-17)||20.185|0.926|
70938688|NCT03745651|141377854|SUPERIORITY||Least Squares Mean Difference|-1.89|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-2.49|-1.29|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 8||-1.29|-2.49|<0.0001
70938689|NCT03745651|141377854|SUPERIORITY||Least Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.3|-1.1|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 8||-1.10|-2.30|<0.0001
70938690|NCT03745651|141377856|SUPERIORITY||Least Squares Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.94|-0.97|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in Skin Pain NRS score at Week 8||-0.97|-1.94|<0.0001
71067630|NCT05406479|141643837|NON_INFERIORITY|For the hypothesis testing of non-inferiority the confidence interval should be compared to the non-inferiority margin. More specifically, non-inferiority is established if the upper limit of a one-sided 95% confidence interval around the difference in means QTc 24 hours after treatment administration (BE-PEP - SDR-PEP) is below the non-inferiority limit of +10 ms. A two-sample t-test was used to compare the two groups, but the p-value returned should not be used to conclude non-inferiority.|Mean Difference (Final Values)|2.076|||||TWO_SIDED|95.0|-3.374|7.525||||||Children (5-12)||7.525|-3.374|
71067631|NCT03567005|141643839|NON_INFERIORITY|The pre-specified non-inferiority margin is 0.05. With a sample size of 36 (18 per sequence group), there was approximately 80% power to reject the null hypothesis of inferiority in distance visual acuity with assumed standard deviation of 0.098 for paired difference (one-sided alpha=0.05).|Least Squares Mean (LSM) Difference|0.0|STANDARD_ERROR_OF_MEAN|0.008|||ONE_SIDED|95.0||0.02||||||||0.02||
71112283|NCT00005947|141731416|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.71||||0.01||95.0|1.13|2.58|||Log Rank||Cox proportional hazards model with treatment as the independent variable \[placebo/sipuleucel-T\].|ITT Population - all randomized participants||2.58|1.13|0.010
70938691|NCT03745651|141377856|SUPERIORITY||Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.72|-0.76|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in Skin Pain NRS score at Week 8||-0.76|-1.72|<0.0001
71067632|NCT03567005|141643840|NON_INFERIORITY|The pre-specified non-inferiority margin is 1.0. With a sample size of 48 (24 per sequence group), there was approximately 80% power to reject the null hypothesis of inferiority in subjective overall vision with assumed standard deviation of 2.29 for paired differences (one-sided alpha=0.05).|LSM Difference|0.0|STANDARD_ERROR_OF_MEAN|0.15|||ONE_SIDED|95.0|-0.3||||||||||-0.3|
71067633|NCT00379080|141643855|OTHER|||||||0.04|||||||Regression, Cox|||VEGFR2||||0.04
71067634|NCT00379080|141643855|OTHER|||||||0.04|||||||Regression, Cox|||PIGF||||0.04
71112284|NCT00005947|141731416|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.586||||0.01|TWO_SIDED|95.0|0.388|0.884|||Log Rank||Cox proportional hazards model with treatment as the independent variable \[sipuleucel-T/placebo\]|ITT Population - all randomized participants.||0.884|0.388|0.010
70938692|NCT03745651|141377859|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.57||0.2903|TWO_SIDED|95.0|-1.71|0.51|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 2||0.51|-1.71|0.2903
70938693|NCT03745651|141377859|SUPERIORITY||Least Squares Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.57||0.0837|TWO_SIDED|95.0|-2.09|0.13|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 2||0.13|-2.09|0.0837
71067635|NCT00379080|141643855|OTHER|||||||0.02|||||||Regression, Cox|||CAIX||||0.02
71067636|NCT00379080|141643855|OTHER|||||||0.05|||||||Regression, Cox|||sFLT\_1||||0.05
71067637|NCT00379080|141643855|OTHER|||||||0.01|||||||Regression, Cox|||sFLT\_1||||0.01
71067638|NCT00379080|141643855|OTHER|||||||0.05|||||||Regression, Cox|||VEGFR2||||0.05
71067639|NCT02901067|141643857|SUPERIORITY|This is a secondary outcome thus no power analysis was done.|||||>|0.05|||||||Fisher Exact|||We hypothesized that the experimental group would present less fibrinolysis shutdown than the control group in all times measured.||||>0.05
71067640|NCT02901067|141643862|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
71067641|NCT02901067|141643865|SUPERIORITY|||||||0.1|||||||Fisher Exact|||We hypothesized that the experimental group would have less pulmonary embolism events than the control group.||||0.10
71067642|NCT02901067|141643866|SUPERIORITY|||||||0.046|||||||Fisher Exact|||We hypothesized that the experimental group would have a lower incidence of venous thromboembolism (VTE) than the control group.||||0.046
71067643|NCT01222520|141643898|SUPERIORITY_OR_OTHER||Least square mean difference|9.14|||<|0.0001||95.0|7.09|11.18|||ANCOVA|||||11.18|7.09|<0.0001
70852745|NCT01578850|141194340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.015|TWO_SIDED|95.0|-2.41|-0.27|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Tender Joint Count: Week 36||-0.27|-2.41|0.015
70938694|NCT03745651|141377859|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.61||0.6272|TWO_SIDED|95.0|-1.5|0.91|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 4||0.91|-1.50|0.6272
71067644|NCT01222520|141643899|SUPERIORITY_OR_OTHER||Least square mean difference|14.88|||<|0.0001||95.0|11.82|17.94|||ANCOVA|||||17.94|11.82|<0.0001
71067645|NCT01222520|141643900|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71067646|NCT01222520|141643901|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71067647|NCT01222520|141643902|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71067648|NCT01222520|141643903|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71067649|NCT01222520|141643904|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71067650|NCT01089608|141643907|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.01||||0.072|TWO_SIDED|95.0|-16.3|0.28|||Mixed Models Analysis|||||0.28|-16.30|0.072
71067651|NCT00955955|141643908|SUPERIORITY_OR_OTHER||Mean Score Reduction|-5.6|STANDARD_DEVIATION|5.7||0.05||95.0|||||SPCD|Sequential Parallel Comparison Design (SPCD)|These results reflect the mean score reduction for the pooled Deplin sample.|Hypothesis 1: There will be a statistically significant difference between the two groups in the degree of improvement, as measured by the change in the 17-item Hamilton Depression Rating Scale (HAM-D-17) score from baseline to endpoint, using the sequential parallel comparison design \[51\]; with a greater degree of reduction in HAM-D-17 scores in the 6(S)-5-MTHF 15 mg qd group than in the placebo group, with the change on placebo being estimated from Trials 1 and 2.||||.05
71067652|NCT03423173|141643910|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|Geometric Mean Titer (GMT) Ratio|0.69|||||TWO_SIDED|95.0|0.46|1.04|||||Analysis of variance (ANOVA) model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-1||1.04|0.46|
71067653|NCT03423173|141643910|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|0.91|||||TWO_SIDED|95.0|0.6|1.38|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-1||1.38|0.60|
71067654|NCT03423173|141643910|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|0.63|||||TWO_SIDED|95.0|0.41|0.96|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-1||0.96|0.41|
71067655|NCT03423173|141643910|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|1.3|||||TWO_SIDED|95.0|0.98|1.71|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-2||1.71|0.98|
71067656|NCT03423173|141643910|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|0.67|||||TWO_SIDED|95.0|0.51|0.88|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-2||0.88|0.51|
71067657|NCT03423173|141643910|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|0.86|||||TWO_SIDED|95.0|0.65|1.15|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-2||1.15|0.65|
71067658|NCT03423173|141643910|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|1.27|||||TWO_SIDED|95.0|0.91|1.78|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-3||1.78|0.91|
71067659|NCT03423173|141643910|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.68|1.33|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-3||1.33|0.68|
71067660|NCT03423173|141643910|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|1.22|||||TWO_SIDED|95.0|0.87|1.71|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-3||1.71|0.87|
71067661|NCT03423173|141643910|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|0.62|||||TWO_SIDED|95.0|0.46|0.82|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-4||0.82|0.46|
71067662|NCT03423173|141643910|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|1.62|||||TWO_SIDED|95.0|1.22|2.17|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-4||2.17|1.22|
71067663|NCT03423173|141643910|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.75|1.35|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-4||1.35|0.75|
71067664|NCT03423173|141643911|OTHER||Seropositivity Rates Difference|0.6|||||TWO_SIDED|95.0|-4.99|6.06|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-1 at Day 120||6.06|-4.99|
70938695|NCT03745651|141377859|SUPERIORITY||Least Squares Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.61||0.1609|TWO_SIDED|95.0|-2.07|0.34|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 4||0.34|-2.07|0.1609
71067665|NCT03423173|141643911|OTHER||Seropositivity Rate Difference|-1.65|||||TWO_SIDED|95.0|-6.9|3.19|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-1 at Day 120||3.19|-6.90|
71067666|NCT03423173|141643911|OTHER||Seropositivity Rate Difference|-2.25|||||TWO_SIDED|95.0|-7.45|2.69|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-1 at Day 120||2.69|-7.45|
71067667|NCT03423173|141643911|OTHER||Seropositivity Rate Difference|7.87|||||TWO_SIDED|95.0|0.64|15.3|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-1 at Day 270||15.30|0.64|
71112285|NCT02195700|141731457|SUPERIORITY||LSM difference|-1.4|STANDARD_ERROR_OF_MEAN|0.6||0.0188|TWO_SIDED|95.0|-2.6|-0.2||5% level of significance (2-sided)|unstructured covariance|||The linear mixed model for repeated measurements (MMRM) included fixed effects for treatment, each scheduled time point (5 levels: weeks 2, 4, 6, 9, and 12), the treatment-by-time point interaction, and the DRA status. Baseline AIMS score was a covariate. The unstructured covariance model was used, and the primary analysis compared the SD-809 and placebo groups at week 12. This was based on the F-test using the Satterhwaite method to compute the denominator degrees of freedom.||-0.2|-2.6|0.0188
70852746|NCT01578850|141194340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.65||||0.003|TWO_SIDED|95.0|-2.72|-0.57|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Tender Joint Count: Week 44||-0.57|-2.72|0.003
71067668|NCT03423173|141643911|OTHER||Seropositivity Rate Difference|1.5|||||TWO_SIDED|95.0|-4.67|7.65|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-1 at Day 270||7.65|-4.67|
71067669|NCT03423173|141643911|OTHER||Seropositivity Rate Difference|-6.37|||||TWO_SIDED|95.0|-14.0|1.04|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-1 at Day 270||1.04|-14.00|
71067670|NCT03423173|141643911|OTHER||Seropositivity Rate Difference|0.72|||||TWO_SIDED|95.0|-3.87|5.29|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-2 at Day 120||5.29|-3.87|
71067671|NCT03423173|141643911|OTHER||Seropositivity Rate Difference|-0.83|||||TWO_SIDED|95.0|-5.24|3.17|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-2 at Day 120||3.17|-5.24|
71067672|NCT03423173|141643911|OTHER||Seropositivity Rate Difference|-1.55|||||TWO_SIDED|95.0|-6.05|2.58|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-2 at Day 120||2.58|-6.05|
71067673|NCT03423173|141643911|OTHER||Seropositivity Rate Difference|2.42|||||TWO_SIDED|95.0|-2.12|7.44|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-2 at Day 270||7.44|-2.12|
71067674|NCT03423173|141643911|OTHER||Seropositivity Rate Difference|0.83|||||TWO_SIDED|95.0|-3.41|5.24|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-2 at Day 270||5.24|-3.41|
71067675|NCT03423173|141643911|OTHER||Seropositivity Rate Difference|-1.59|||||TWO_SIDED|95.0|-6.67|3.17|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-2 at Day 270||3.17|-6.67|
71067676|NCT03423173|141643911|OTHER||Seropositivity Rate Difference|2.93|||||TWO_SIDED|95.0|-3.07|9.06|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-3 at Day 120||9.06|-3.07|
70938696|NCT03745651|141377859|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.73||0.3362|TWO_SIDED|95.0|-2.13|0.73|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 8||0.73|-2.13|0.3362
70938697|NCT03745651|141377859|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.73||0.269|TWO_SIDED|95.0|-2.23|0.62|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 8||0.62|-2.23|0.2690
70938698|NCT03745651|141377860|SUPERIORITY||Least Squares Mean Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.54||0.0482|TWO_SIDED|95.0|-2.13|-0.01|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 2||-0.01|-2.13|0.0482
70938699|NCT03745651|141377860|SUPERIORITY||Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.54||0.0271|TWO_SIDED|95.0|-2.26|-0.14|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 2||-0.14|-2.26|0.0271
70938700|NCT03745651|141377860|SUPERIORITY||Least Squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.6||0.2091|TWO_SIDED|95.0|-1.94|0.42|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 4||0.42|-1.94|0.2091
70938701|NCT03745651|141377860|SUPERIORITY||Least Squares Mean Difference|-1.53|STANDARD_ERROR_OF_MEAN|0.6||0.0111|TWO_SIDED|95.0|-2.71|-0.35|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 4||-0.35|-2.71|0.0111
70938702|NCT03745651|141377860|SUPERIORITY||Least Squares Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.68||0.0802|TWO_SIDED|95.0|-2.51|0.14|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 8||0.14|-2.51|0.0802
70938703|NCT03745651|141377860|SUPERIORITY||Least Squares Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.67||0.0666|TWO_SIDED|95.0|-2.56|0.09|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 8||0.09|-2.56|0.0666
71067677|NCT03423173|141643911|OTHER||Seropositivity Rate Difference|-0.81|||||TWO_SIDED|95.0|-6.17|4.44|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-3 at Day 120||4.44|-6.17|
71067678|NCT03423173|141643911|OTHER||Seropositivity Rate Difference|-3.73|||||TWO_SIDED|95.0|-9.74|2.03|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-3 at Day 120||2.03|-9.74|
71067679|NCT03423173|141643911|OTHER||Seropositivity Rate Difference|6.79|||||TWO_SIDED|95.0|-1.03|14.56|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-3 at Day 270||14.56|-1.03|
71067680|NCT03423173|141643911|OTHER||Seropositivity Rate Difference|3.0|||||TWO_SIDED|95.0|-4.28|10.23|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-3 at Day 270||10.23|-4.28|
70938704|NCT03745651|141377863|SUPERIORITY||Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-4.84|-2.97|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in %BSA at Week 8||-2.97|-4.84|<0.0001
70938705|NCT03745651|141377863|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|0.47|<|0.0001|TWO_SIDED|95.0|-5.47|-3.63|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in %BSA at Week 8||-3.63|-5.47|<0.0001
70938706|NCT03745651|141377865|SUPERIORITY||Least Squares Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001|TWO_SIDED|95.0|-7.38|-4.86|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in POEM score at Week 8||-4.86|-7.38|<0.0001
70938707|NCT03745651|141377865|SUPERIORITY||Least Squares Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001|TWO_SIDED|95.0|-7.17|-4.67|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in POEM score at Week 8||-4.67|-7.17|<0.0001
71067681|NCT03423173|141643911|OTHER||Seropositivity Rate Difference|-3.79|||||TWO_SIDED|95.0|-11.97|4.39|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-3 at Day 270||4.39|-11.97|
71067682|NCT03423173|141643911|OTHER||Seropositivity Rate Difference|-2.5|||||TWO_SIDED|95.0|-7.68|1.55|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-4 at Day 120||1.55|-7.68|
71067683|NCT03423173|141643911|OTHER||Seropositivity Rate Difference|0.04|||||TWO_SIDED|95.0|-5.47|5.62|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-4 at Day 120||5.62|-5.47|
71067684|NCT03423173|141643911|OTHER||Seropositivity Rate Difference|2.54|||||TWO_SIDED|95.0|-1.52|7.81|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-4 at Day 120||7.81|-1.52|
71067685|NCT03423173|141643911|OTHER||Seropositivity Rate Difference|-1.52|||||TWO_SIDED|95.0|-9.14|5.69|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-4 at Day 270||5.69|-9.14|
71067686|NCT03423173|141643911|OTHER||Seropositivity Rate Difference|1.13|||||TWO_SIDED|95.0|-6.9|8.95|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-4 at Day 270||8.95|-6.90|
70938708|NCT03745651|141377867|SUPERIORITY||Least Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-4.19|-2.32|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total DLQI score at Week 8||-2.32|-4.19|<0.0001
70938709|NCT03745651|141377867|SUPERIORITY||Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.47|<|0.0001|TWO_SIDED|95.0|-3.67|-1.83|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total DLQI score at Week 8||-1.83|-3.67|<0.0001
70938710|NCT03745651|141377869|SUPERIORITY||Least Squares Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|1.55||0.0099|TWO_SIDED|95.0|-7.24|-1.03|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total CDLQI score at Week 8||-1.03|-7.24|0.0099
70938711|NCT03745651|141377869|SUPERIORITY||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|1.59||0.0542|TWO_SIDED|95.0|-6.3|0.06|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total CDLQI score at Week 8||0.06|-6.30|0.0542
70938712|NCT03745651|141377873|SUPERIORITY||Odds Ratio (OR)|5.16|||<|0.0001|TWO_SIDED|95.0|2.987|9.049||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||Percentage of participants with a score of either 1 or 2 on the PGIC at Week 8||9.049|2.987|<0.0001
70938713|NCT03745651|141377873|SUPERIORITY||Odds Ratio (OR)|7.47|||<|0.0001|TWO_SIDED|95.0|4.23|13.415||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||Percentage of participants with a score of either 1 or 2 on the PGIC at Week 8||13.415|4.230|<0.0001
70938714|NCT03745651|141377874|SUPERIORITY||Least Squares Mean Difference|4.4|STANDARD_ERROR_OF_MEAN|1.78||0.015|TWO_SIDED|95.0|0.85|7.86|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in EQ VAS score at Week 8||7.86|0.85|0.0150
71067687|NCT03423173|141643911|OTHER||Seropositivity Rate Difference|2.64|||||TWO_SIDED|95.0|-4.68|10.18|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-4 at Day 270||10.18|-4.68|
71067688|NCT03423173|141643912|OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.56|1.42|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-1||1.42|0.56|
71067689|NCT03423173|141643912|OTHER||GMT Ratio|0.81|||||TWO_SIDED|95.0|0.51|1.28|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-1||1.28|0.51|
71067690|NCT03423173|141643912|OTHER||GMT Ratio|0.73|||||TWO_SIDED|95.0|0.46|1.16|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-1||1.16|0.46|
71112286|NCT02195700|141731458|SUPERIORITY||Differences in %|7.9||||0.4001|TWO_SIDED|95.0|-10.2|25.2||5% level of significance (2-sided)|Pearson's chi-square test|||The secondary efficacy endpoints were analyzed using a hierarchical testing procedure. If the primary analysis was statistically significant (p\<0.05), then the first key secondary endpoint was to be analyzed. If the first key secondary endpoint was statistically significant, then the second key secondary endpoint was to be similarly analyzed. For any analysis that was not statistically significant, all subsequent analyses of key secondary endpoints were exploratory rather than confirmatory.||25.2|-10.2|0.4001
70938715|NCT03745651|141377874|SUPERIORITY||Least Squares Mean Difference|5.1|STANDARD_ERROR_OF_MEAN|1.77||0.0044|TWO_SIDED|95.0|1.59|8.54|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in EQ VAS score at Week 8||8.54|1.59|0.0044
70938716|NCT03745651|141377875|SUPERIORITY||Least Squares Mean Difference|-5.6|STANDARD_ERROR_OF_MEAN|3.81||0.142|TWO_SIDED|95.0|-13.12|1.89|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent work time missed due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||1.89|-13.12|0.1420
70938717|NCT03745651|141377875|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|3.82||0.0375|TWO_SIDED|95.0|-15.51|-0.47|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent work time missed due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-0.47|-15.51|0.0375
70941799|NCT04748445|141383937|OTHER||Slope|0.02424|STANDARD_ERROR_OF_MEAN|1.021||0.9811|TWO_SIDED|90.0|-1.667|1.716|||Mixed Models Analysis|||MM\_Formant 1 Bandwidth (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^0).||1.716|-1.667|0.9811
71067691|NCT03423173|141643912|OTHER||GMT Ratio|1.37|||||TWO_SIDED|95.0|1.02|1.86|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-2||1.86|1.02|
71112287|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L inferior frontal gyrus||||<0.05
71067692|NCT03423173|141643912|OTHER||GMT Ratio|0.65|||||TWO_SIDED|95.0|0.48|0.87|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-2||0.87|0.48|
71067693|NCT03423173|141643912|OTHER||GMT ratio|0.89|||||TWO_SIDED|95.0|0.66|1.21|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-2||1.21|0.66|
71067694|NCT03423173|141643912|OTHER||GMT Ratio|1.4|||||TWO_SIDED|95.0|1.0|1.94|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-3||1.94|1.00|
71067695|NCT03423173|141643912|OTHER||GMT Ratio|0.88|||||TWO_SIDED|95.0|0.64|1.21|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-3||1.21|0.64|
71067696|NCT03423173|141643912|OTHER||GMT Ratio|1.23|||||TWO_SIDED|95.0|0.88|1.71|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-3||1.71|0.88|
71067697|NCT03423173|141643912|OTHER||GMT Ratio|0.83|||||TWO_SIDED|95.0|0.58|1.18|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-4||1.18|0.58|
70938718|NCT03745651|141377875|SUPERIORITY||Least Squares Mean Difference|-9.1|STANDARD_ERROR_OF_MEAN|2.75||0.0012|TWO_SIDED|95.0|-14.48|-3.63|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent impairment while working due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-3.63|-14.48|0.0012
70938719|NCT03745651|141377875|SUPERIORITY||Least Squares Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|2.74||0.0095|TWO_SIDED|95.0|-12.58|-1.77|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent impairment while working due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-1.77|-12.58|0.0095
70938720|NCT03745651|141377875|SUPERIORITY||Least Squares Mean Difference|-15.2|STANDARD_ERROR_OF_MEAN|3.8|<|0.0001|TWO_SIDED|95.0|-22.69|-7.73|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent overall work impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-7.73|-22.69|<0.0001
70938721|NCT03745651|141377875|SUPERIORITY||Least Squares Mean Difference|-12.6|STANDARD_ERROR_OF_MEAN|3.79||0.001|TWO_SIDED|95.0|-20.1|-5.18|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent overall work impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-5.18|-20.10|0.0010
70938722|NCT03745651|141377875|SUPERIORITY||Least Squares Mean Difference|-12.1|STANDARD_ERROR_OF_MEAN|2.09|<|0.0001|TWO_SIDED|95.0|-16.18|-7.95|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent activity impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-7.95|-16.18|<0.0001
70938723|NCT03745651|141377875|SUPERIORITY||Least Squares Mean Difference|-10.4|STANDARD_ERROR_OF_MEAN|2.08|<|0.0001|TWO_SIDED|95.0|-14.53|-6.37|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent activity impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-6.37|-14.53|<0.0001
70938724|NCT04883541|141377891|SUPERIORITY|the t-test in independent groups|Mean Difference (Net)|0.02|STANDARD_DEVIATION|0.8|<|0.05|TWO_SIDED|0.05|||||t-test, 2 sided|||||||<0.05
70938725|NCT01383616|141377892|SUPERIORITY|||||||0.85|||||||t-test, 2 sided|||Comparison of 3 month ODI Score between Unipedicular and Bipedicular kyphoplasty groups||||0.85
70938726|NCT01383616|141377893|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||0.008
70938727|NCT01383616|141377894|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
70938728|NCT01383616|141377895|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||||||0.93
70938729|NCT01383616|141377896|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
70938730|NCT01383616|141377897|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
70938731|NCT01383616|141377898|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||||||0.90
70938732|NCT01383616|141377899|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
70938733|NCT01383616|141377900|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||||||0.87
70938734|NCT01383616|141377901|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
71067698|NCT03423173|141643912|OTHER||GMT Ratio|1.51|||||TWO_SIDED|95.0|1.07|2.14|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-4||2.14|1.07|
71067699|NCT03423173|141643912|OTHER||GMT Ratio|1.25|||||TWO_SIDED|95.0|0.88|1.78|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-4||1.78|0.88|
71067700|NCT02920008|141643918|SUPERIORITY||||||=|0.3287|||||||Stratified log-rank|||||||= 0.3287
71067701|NCT03169881|141643941|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.88|TWO_SIDED|95.0|-3.09|2.64||The mean difference in Bayley-III cognitive scores between treatment groups was adjusted for center, gestational age group, and familial clustering.|Mixed Models Analysis||Adjusted mean difference in cognitive score for the Darbepoetin minus Placebo treatment groups.|Null hypothesis: Weekly administration of Darbepoetin during the neonatal period will not impact neurocognitive outcomes at 22-26 months compared to Placebo in premature infants 23 to 28 weeks gestation.||2.64|-3.09|0.88
71067702|NCT03852264|141643955|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|2.61|||||TWO_SIDED|90.0|-1.29|6.38|||||Contrast reflecting Pet Dog Interaction - Toys Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||6.38|-1.29|
71067703|NCT03852264|141643955|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|1.62|||||TWO_SIDED|90.0|-2.18|5.45|||||Contrast reflecting Unfamiliar Dog Interaction - Toys Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||5.45|-2.18|
71067704|NCT03852264|141643955|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|-1.0|||||TWO_SIDED|90.0|-4.93|2.83|||||Contrast reflecting Unfamiliar Dog Interaction - Pet Dog Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||2.83|-4.93|
71067705|NCT03852264|141643956|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|0.3482|||||TWO_SIDED|90.0|-0.476|1.211|||||Contrast reflecting Pet Dog Interaction - Toys Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||1.211|-0.476|
71067706|NCT03852264|141643956|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|-0.0635|||||TWO_SIDED|90.0|-0.931|0.803|||||Contrast reflecting Unfamiliar Dog Interaction - Toys Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||0.803|-0.931|
71067707|NCT03852264|141643956|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|-0.422|||||TWO_SIDED|90.0|-1.319|0.445|||||Contrast reflecting Unfamiliar Dog Interaction - Pet Dog Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||0.445|-1.319|
71067708|NCT03852264|141643957|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|0.468|||||TWO_SIDED|90.0|-101.0|99.5|||||Contrast reflecting Pet Dog Interaction - Toys Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||99.5|-101|
71067709|NCT03852264|141643957|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|-115.0|||||TWO_SIDED|90.0|-225.0|-15.5|||||Contrast reflecting Unfamiliar Dog Interaction - Toys Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||-15.5|-225|
71067710|NCT03852264|141643957|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|-115.48|||||TWO_SIDED|90.0|-223.0|-16.2|||||Contrast reflecting Unfamiliar Dog Interaction - Pet Dog Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||-16.2|-223|
71067711|NCT01631149|141643959|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7|STANDARD_DEVIATION|0.4|<|0.001|||||||t-test, 2 sided|||"The individual scores obtained during surgery were averaged.~The average values were compared using a t-test between treatments."||||<0.001
71067712|NCT02217410|141643978|OTHER||Mean Difference (Final Values)|0.095||||0.8976|TWO_SIDED|95.0|-0.067|0.263|||Bayesian posterior probability|Posterior probability that the composite efficacy failure difference between CFZ533 and Tac is \< 20%.|Month 3|||0.263|-0.067|0.8976
71067713|NCT02217410|141643978|OTHER||Mean Difference (Final Values)|0.093||||0.8836|TWO_SIDED|95.0|-0.084|0.271|||Bayesian posterior probability|Posterior probability that the composite efficacy failure difference between CFZ533 and Tac is \< 20%.|Month 6|||0.271|-0.084|0.8836
71067714|NCT02217410|141643978|OTHER||Mean Difference (Final Values)|0.093||||0.8822|TWO_SIDED|95.0|-0.085|0.272|||Bayesian posterior probability|Posterior probability that the composite efficacy failure difference between CFZ533 and Tac is \< 20%.|Month 9|||0.272|-0.085|0.8822
71067715|NCT02217410|141643978|OTHER||Mean Difference (Final Values)|0.093||||0.8821|TWO_SIDED|95.0|-0.087|0.273|||Bayesian posterior probability|Posterior probability that the composite efficacy failure difference between CFZ533 and Tac is \< 20%.|Month 12|||0.273|-0.087|0.8821
71067716|NCT00637000|141643992|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|The statistical method used was a group by time repeated measures model with a first-order autoregressive covariance structure||To test the primary study hypothesis that neither soluble film formulation would precipitate an opioid withdrawal syndrome, peak COWS score in the 23.5 hour period after the initial soluble film administration were compared to pre-administration baseline COWS scores (30 minutes prior to soluble film administration) using a group by time repeated measures model with a first-order autoregressive covariance structure.||||<0.0001
71067717|NCT00637000|141643993|SUPERIORITY_OR_OTHER|||||||0|||||||Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.000
71067718|NCT00637000|141643994|SUPERIORITY_OR_OTHER|||||||0.035||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.035
71067719|NCT00637000|141643995|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
71067720|NCT00637000|141643996|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
71067721|NCT00637000|141643997|SUPERIORITY_OR_OTHER|||||||0.006||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.006
71067722|NCT00637000|141643998|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
71067723|NCT00637000|141643999|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
71067724|NCT00637000|141644000|SUPERIORITY_OR_OTHER|||||||0.762||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.762
71067725|NCT00637000|141644001|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
71067726|NCT00637000|141644002|SUPERIORITY_OR_OTHER|||||||0.349||||||The p-value is not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.349
71067727|NCT00637000|141644003|SUPERIORITY_OR_OTHER|||||||0.028||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.028
71067728|NCT00637000|141644004|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
71067729|NCT00637000|141644005|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
71067730|NCT00637000|141644006|SUPERIORITY_OR_OTHER|||||||0.117||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.117
71067731|NCT00637000|141644007|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
71067732|NCT00637000|141644008|SUPERIORITY_OR_OTHER|||||||0.238||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.238
71112288|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Desire to void: L superior temporal gyrus||||<0.05
71112289|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L inferior temporal gyrus||||<0.05
71112290|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L middle temporal gyrus||||<0.05
71112291|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R middle temporal gyrus||||<0.05
71112292|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L inferior parietal lobule||||<0.05
71112293|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R inferior parietal lobule||||<0.05
71112294|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R paracentral lobule||||<0.05
71112295|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R superior parietal lobule||||<0.05
71112296|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R supplementary motor area||||<0.05
71112297|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L postcentral gyrus||||<0.05
71112298|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R postcentral gyrus||||<0.05
71112299|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L angular gyrus||||<0.05
71112300|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R supramarginal gyrus||||<0.05
71112301|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L superior medial gyrus||||<0.05
71112302|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L inferior occipital gyrus||||<0.05
71112303|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L middle cingulate cortex||||<0.05
71112304|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R middle cingulate cortex||||<0.05
71112305|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R posterior cingulate cortex||||<0.05
71112306|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L thalamus||||<0.05
71112307|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R thalamus||||<0.05
71112308|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L precuneus||||<0.05
71112309|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R precuneus||||<0.05
71112310|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L caudate nucleus||||<0.05
71112311|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire void: L hippocampus||||<0.05
71112312|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L hippocampus||||<0.05
71112313|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L putamen||||<0.05
71112314|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L precentral gyrus||||<0.05
71112315|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R precentral gyrus||||<0.05
71112316|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L insula lobe||||<0.05
71112317|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L superior frontal gyrus||||<0.05
71112318|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L middle frontal gyrus||||<0.05
71112319|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R cerebellum||||<0.05
71112320|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R fusiform gyrus||||<0.05
71112321|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L postcentral gyrus||||<0.05
71112322|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R postcentral gyrus||||<0.05
71112323|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L precentral gyrus||||<0.05
71112324|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R precentral gyrus||||<0.05
71112325|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L superior temporal gyrus||||<0.05
71112326|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R superior temporal gyrus||||<0.05
71112327|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L middle temporal gyrus||||<0.05
71112328|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R middle temporal gyrus||||<0.05
71112329|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L inferior temporal gyrus||||<0.05
71112330|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L supramarginal gyrus||||<0.05
71112331|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R supramarginal gyrus||||<0.05
71112332|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding Initiation: L inferior occipital gyrus||||<0.05
71112333|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R superior occipital gyrus||||<0.05
71112334|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding Initiation: R middle occipital gyrus||||<0.05
71112335|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L inferior frontal gyrus (p. Orbitalis)||||<0.05
71112336|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L inferior frontal gyrus (p. Triangularis)||||<0.05
71112337|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L inferior frontal gyrus (p. Opercularis)||||<0.05
71112338|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R inferior frontal gyrus (p. Orbitalis)||||<0.05
71112339|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R inferior frontal gyrus (p. Triangularis)||||<0.05
71067733|NCT00839527|141644015|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.87|||<|0.0001|TWO_SIDED|95.0|-1.07|-0.68|||ANCOVA|||||-0.68|-1.07|<0.0001
71067734|NCT00839527|141644015|NON_INFERIORITY_OR_EQUIVALENCE|The p-value is from a one-sided t-test testing at the 0.025 level of significance whether or not the difference of least square means (albiglutide - pioglitazone) is less than or equal to the pre-specified non-inferiority margin of 0.3%.|Mean Difference (Net)|0.25||||0.2685|TWO_SIDED|95.0|0.1|0.4|||t-test, 1 sided|||||0.40|0.10|0.2685
71067735|NCT00943150|141644029|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|||||||<0.001
70941800|NCT04748445|141383937|OTHER||Slope|-0.9256|STANDARD_ERROR_OF_MEAN|1.083||0.3944|TWO_SIDED|90.0|-2.72|0.869|||Mixed Models Analysis|||MM\_Formant 2 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^0).||0.8690|-2.720|0.3944
71067736|NCT00943150|141644030|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||ANOVA|||CD3+ at 0 weeks||||0.33
71067737|NCT00943150|141644030|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|||CD3+ at 3 weeks||||0.02
71067738|NCT00943150|141644030|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||ANOVA|||CD3+ at 6 weeks||||0.71
71067739|NCT00943150|141644030|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||ANOVA|||CD68+ at 0 weeks||||0.67
71067740|NCT00943150|141644030|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|||CD68+ at 3 weeks||||0.01
71067741|NCT00943150|141644030|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||ANOVA|||CD68+ at 6 weeks||||0.48
71112340|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L cerebellum||||<0.05
71112341|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L rectal gyrus||||<0.05
71112342|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R rectal gyrus||||<0.05
71067742|NCT00943150|141644031|SUPERIORITY_OR_OTHER|||||||0.1128||95.0|||||Exact Wilcoxon rank-sum test|||||||0.1128
71067743|NCT00943150|141644032|SUPERIORITY_OR_OTHER|||||||0.0898||95.0|||||Exact Wilcoxon test|||||||0.0898
71067744|NCT00943150|141644033|SUPERIORITY_OR_OTHER|||||||0.076||95.0|||||Exact Wilcoxon test|||Intraoperative narcotic use comparison||||0.0760
71067745|NCT00943150|141644033|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||Exact Wilcoxon test|||Postoperative narcotic use comparison||||0.5900
71067746|NCT00943150|141644034|SUPERIORITY_OR_OTHER|||||||0.4589||95.0|||||Exact Wilcoxon test|||||||0.4589
71067747|NCT00943150|141644035|SUPERIORITY_OR_OTHER|||||||0.999||95.0|||||Exact Wilcoxon test|||||||0.999
71067748|NCT00943150|141644036|SUPERIORITY_OR_OTHER|||||||0.0412||95.0|||||Exact Wilcoxon test|||||||0.0412
71067749|NCT04431908|141644037|OTHER|Sensitivity, specificity and accuracy was measured utilizing the true and false positives, as well as the true and false negatives. For a subject to have a true positive, the subject must have had a positive PCR test for COVID-19 as well as scored 0, 1 or 2 correct answers on the smell test. For a subject to have a true negative, the subject must have had a negative PCR test for COVID-19 as well as scored 3, 4 or 5 correct answers on the smell test.|Specificity|89.35|||||TWO_SIDED|||||||||||||
71067750|NCT04431908|141644037|OTHER|Sensitivity, specificity and accuracy was measured utilizing the true and false positives, as well as the true and false negatives. For a subject to have a true positive, the subject must have had a positive PCR test for COVID-19 as well as scored 0, 1 or 2 correct answers on the smell test. For a subject to have a true negative, the subject must have had a negative PCR test for COVID-19 as well as scored 3, 4 or 5 correct answers on the smell test.|Sensitivity|42.55|||||TWO_SIDED|||||||||||||
71067751|NCT04431908|141644037|OTHER|Sensitivity, specificity and accuracy was measured utilizing the true and false positives, as well as the true and false negatives. For a subject to have a true positive, the subject must have had a positive PCR test for COVID-19 as well as scored 0, 1 or 2 correct answers on the smell test. For a subject to have a true negative, the subject must have had a negative PCR test for COVID-19 as well as scored 3, 4 or 5 correct answers on the smell test.|Accuracy|87.24|||||TWO_SIDED|||||||||||||
71067752|NCT04431908|141644039|OTHER|Sensitivity, specificity and accuracy was measured utilizing the true and false positives, as well as the true and false negatives. For a subject to have a true positive, the subject must have had a positive PCR test for COVID-19 as well as scored 0, 1 or 2 correct answers on the smell test. For a subject to have a true negative, the subject must have had a negative PCR test for COVID-19 as well as scored 3, 4 or 5 correct answers on the smell test.|Specificity|88.73|||||TWO_SIDED|||||||||||||
71067753|NCT04431908|141644039|OTHER|Sensitivity, specificity and accuracy was measured utilizing the true and false positives, as well as the true and false negatives. For a subject to have a true positive, the subject must have had a positive PCR test for COVID-19 as well as scored 0, 1 or 2 correct answers on the smell test. For a subject to have a true negative, the subject must have had a negative PCR test for COVID-19 as well as scored 3, 4 or 5 correct answers on the smell test.|Sensitivity|33.33|||||TWO_SIDED|||||||||||||
71067754|NCT04431908|141644039|OTHER|Sensitivity, specificity and accuracy was measured utilizing the true and false positives, as well as the true and false negatives. For a subject to have a true positive, the subject must have had a positive PCR test for COVID-19 as well as scored 0, 1 or 2 correct answers on the smell test. For a subject to have a true negative, the subject must have had a negative PCR test for COVID-19 as well as scored 3, 4 or 5 correct answers on the smell test.|Accuracy|88.13|||||TWO_SIDED|||||||||||||
71067755|NCT01704651|141644040|SUPERIORITY_OR_OTHER|||||||0.34|||||||t-test, 2 sided|||||||0.34
71067756|NCT01704651|141644041|SUPERIORITY_OR_OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
71067757|NCT03315286|141644042|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
71067758|NCT03315286|141644043|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
71067759|NCT03315286|141644044|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||Baseline results are reported here.||||0.6
71067760|NCT03315286|141644044|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||6 month data is reported here||||0.3
71067761|NCT03315286|141644045|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||Baseline data is reported here.||||0.2
71067762|NCT03315286|141644045|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||6 month data is reported here||||0.4
71067763|NCT03315286|141644046|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||baseline data is reported here||||0.07
71112343|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L superior medial gyrus||||<0.05
71112344|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R superior medial gyrus||||<0.05
71112345|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L superior frontal gyrus||||<0.05
71067764|NCT03315286|141644046|SUPERIORITY|||||||0.0002|||||||t-test, 2 sided|||6 month data is reported here||||0.0002
71067765|NCT03075891|141644048|SUPERIORITY|||||||0.032|||||||Cochran-Mantel-Haenszel|||||||0.032
71067766|NCT00828568|141644079|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence limit around the difference in proportion of patients considered a Treatment Success between test and reference products was calculated using Blackwelder's method with Yate's continuity correction. If the 90% confidence interval for the test to reference ratio for the primary endpoint was within -0.20 to +0.20, then the test product would have been declared therapeutically equivalent to the reference product.|Mean Difference (Final Values)|4.85||||||90.0|-5.37|15.08||||||||15.08|-5.37|
71067767|NCT00828568|141644081|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
71067768|NCT00828568|141644081|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<.0001
71067769|NCT02477332|141644107|SUPERIORITY||Estimated target dose|32.5|||<|0.05|TWO_SIDED|60.0|27.5|42.5|||Regression, Logistic|Target dose was based on this estimated dose response. The 60% CI included the 20 - 80th percentile of target dose estimated in the bootstrap samples.|Min dose with effect size \>15%|||42.5|27.5|<.05
71067770|NCT02549287|141644120|SUPERIORITY||Odds Ratio, log|0.55||||0.12|TWO_SIDED|95.0|-0.11|1.2||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||1.20|-0.11|0.12
71067771|NCT02549287|141644121|SUPERIORITY||Odds Ratio, log|0.41||||0.14|TWO_SIDED|95.0|-0.2|1.03||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||1.03|-0.20|0.14
71067772|NCT02549287|141644122|SUPERIORITY||Odds Ratio, log|0.44||||0.2|TWO_SIDED|95.0|-0.2|1.07||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||1.07|-0.20|0.20
71067773|NCT02549287|141644123|SUPERIORITY||Odds Ratio, log|-0.07||||0.77|TWO_SIDED|95.0|-0.58|0.43||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.43|-0.58|0.77
71067774|NCT02549287|141644124|SUPERIORITY||Odds Ratio, log|0.35||||0.29|TWO_SIDED|95.0|-0.27|0.97|||Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.97|-0.27|0.29
71067775|NCT02549287|141644125|SUPERIORITY||Odds Ratio, log|0.49||||0.15|TWO_SIDED|95.0|-0.08|1.06||Other \[Marginal Model (e.g., GEE)\]|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||1.06|-0.08|0.15
71067776|NCT02549287|141644126|SUPERIORITY||Odds Ratio, log|-0.11||||0.61|TWO_SIDED|95.0|-0.73|0.52||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.52|-0.73|0.61
71067777|NCT02549287|141644127|SUPERIORITY||Odds Ratio, log|-0.22||||0.47|TWO_SIDED|95.0|-0.76|0.32||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.32|-0.76|0.47
71067778|NCT02549287|141644128|SUPERIORITY||Slope|-0.75||||0.65|TWO_SIDED|95.0|-3.7|2.2||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||2.20|-3.70|0.65
71067779|NCT02549287|141644129|SUPERIORITY||Odds Ratio, log|0.05||||0.64|TWO_SIDED|95.0|-0.59|0.69||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.69|-0.59|0.64
71067780|NCT02549287|141644130|SUPERIORITY||Odds Ratio, log|-0.25||||0.44|TWO_SIDED|95.0|-0.79|0.29||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.29|-0.79|0.44
71067781|NCT02549287|141644131|SUPERIORITY||Odds Ratio, log|0.25||||0.47|TWO_SIDED|95.0|-0.39|0.89||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.89|-0.39|0.47
71067782|NCT02549287|141644132|SUPERIORITY||Slope|-0.18||||0.63|TWO_SIDED|95.0|-3.57|3.22||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||3.22|-3.57|0.63
71067783|NCT04463251|141644173|OTHER||Least square means ratio|0.58|||||TWO_SIDED|95.0|0.37|0.91|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 80 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.91|0.37|
71067784|NCT04463251|141644173|OTHER||Least square means ratio|0.58|||||TWO_SIDED|95.0|0.37|0.91|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 160 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.91|0.37|
71067785|NCT04463251|141644174|OTHER||Least square means ratio|0.54|||||TWO_SIDED|95.0|0.34|0.87|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 80 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.87|0.34|
71078881|NCT01964716|141665745|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.67|1.25||||||Serotype 23F: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.25|0.67|
70938735|NCT01124916|141377913|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8728.0|STANDARD_ERROR_OF_MEAN|853.129|<|0.001|TWO_SIDED|95.0|7028.846|10427.154|||t-test, 2 sided|||The null hypothesis is that there is no difference in the total cost of care between standard and robotic-assisted laparoscopic abdominal sacrocolpopexy six weeks after surgery.||10427.154|7028.846|<.001
70938736|NCT01124916|141377914|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.2|STANDARD_ERROR_OF_MEAN|7.846||0.43|TWO_SIDED|95.0|-21.769|9.369|||t-test, 2 sided|||The null hypothesis is that there is no difference in urinary distress between women assigned to LASC and those assigned to RASC six months after intervention as measured by the UDI.||9.369|-21.769|.43
71067786|NCT04463251|141644174|OTHER||Least square means ratio|0.6|||||TWO_SIDED|95.0|0.37|0.95|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 160 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.95|0.37|
71067787|NCT04463251|141644175|OTHER||Least square means ratio|0.56|||||TWO_SIDED|95.0|0.34|0.91|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 80 mg / Placebo.~Ratio was calculated instead of difference because log data transformation"|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.91|0.34|
71067788|NCT04463251|141644175|OTHER||Least square means ratio|0.61|||||TWO_SIDED|95.0|0.38|0.98|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 160 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.98|0.38|
71067789|NCT04463251|141644176|OTHER||Least square means ratio|0.56|||||TWO_SIDED|95.0|0.34|0.91|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 80 mg / Placebo.~Ratio was calculated instead of difference because log data transformation"|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.91|0.34|
71067790|NCT04463251|141644176|OTHER||Least square means ratio|0.61|||||TWO_SIDED|95.0|0.38|0.98|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 160 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.98|0.38|
71067791|NCT04463251|141644177|OTHER||Least square means ratio|0.52|||||TWO_SIDED|95.0|0.34|0.81||||||"The following (two-sided) hypotheses were tested:~Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is equal to 1.~Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is different from 1."|"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 80 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|0.81|0.34|
71067792|NCT04463251|141644177|OTHER||Least square means ratio|0.48|||||TWO_SIDED|95.0|0.31|0.74|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 160 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is equal to 1.~Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is different from 1."||0.74|0.31|
70938737|NCT03014726|141377922|OTHER|Recurrence \< 0.5 as defined by an IPSS score of less than or equal to 11. The performance goal is met if the upper limit of the one-sided 95% confidence interval for recurrence is less than 50%.|||||<|0.001|||||||1-sample binomial z-test|||||||<0.001
71067793|NCT04463251|141644178|OTHER||Least square means ratio|0.47|||||TWO_SIDED|95.0|0.29|0.75|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 80 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is equal to 1.~Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is different from 1."||0.75|0.29|
71078882|NCT02179749|141665779|SUPERIORITY||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.2||0.51|TWO_SIDED||||||ANOVA|||||||0.51
70938738|NCT05265247|141377924|EQUIVALENCE|The two formulations were considered to be bioequivalent if the point estimate for the ratio lies completely within the range of 0.8-1.25.|Ratio of Geometric least squares mean|0.9531|||||TWO_SIDED|90.0|0.851|1.0673||||||||1.0673|0.8510|
70938739|NCT05265247|141377925|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% 2-sided confidence interval (CI) for the ratio lies completely within the range of 0.8-1.25.|Ratio of Geometric least squares mean|0.9538|||||TWO_SIDED|90.0|0.898|1.0132||||||||1.0132|0.8980|
71067794|NCT04463251|141644178|OTHER||Least square means ratio|0.47|||||TWO_SIDED|95.0|0.3|0.75|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 160 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is equal to 1.~Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is different from 1."||0.75|0.30|
71067795|NCT01314872|141644234|SUPERIORITY_OR_OTHER||Difference in least squares (LS) means|-0.46||||0.056|TWO_SIDED|95.0|-0.92|0.01|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.||||0.01|-0.92|0.056
71067796|NCT01314872|141644234|SUPERIORITY_OR_OTHER||Difference in LS means|-0.45||||0.064|TWO_SIDED|95.0|-0.93|0.03|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.||||0.03|-0.93|0.064
71067797|NCT01314872|141644234|SUPERIORITY_OR_OTHER||Difference in LS means|-0.64||||0.007|TWO_SIDED|95.0|-1.11|-0.18|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.||||-0.18|-1.11|0.007
71067798|NCT01314872|141644234|SUPERIORITY_OR_OTHER||Difference in LS means|-0.91|||<|0.001|TWO_SIDED|95.0|-1.37|-0.44|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.||||-0.44|-1.37|< 0.001
71067799|NCT01314872|141644234|SUPERIORITY_OR_OTHER||Difference in LS means|-0.54||||0.026|TWO_SIDED|95.0|-1.02|-0.07|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.||||-0.07|-1.02|0.026
71067800|NCT01314872|141644239|SUPERIORITY_OR_OTHER||Difference in LS means|-0.28||||0.167|TWO_SIDED|95.0|-0.68|0.12|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||0.12|-0.68|0.167
71067801|NCT01314872|141644239|SUPERIORITY_OR_OTHER||Difference in LS means|-0.57||||0.005|TWO_SIDED|95.0|-0.97|-0.17|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.17|-0.97|0.005
71067802|NCT01314872|141644239|SUPERIORITY_OR_OTHER||Difference in LS means|-0.72|||<|0.001|TWO_SIDED|95.0|-1.11|-0.33|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.33|-1.11|< 0.001
71067803|NCT01314872|141644239|SUPERIORITY_OR_OTHER||Difference in LS means|-0.71|||<|0.001|TWO_SIDED|95.0|-1.1|-0.32|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.32|-1.10|< 0.001
71067804|NCT01314872|141644239|SUPERIORITY_OR_OTHER||Difference in LS means|-0.46||||0.03|TWO_SIDED|95.0|-0.87|-0.04|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.04|-0.87|0.030
71067805|NCT01314872|141644240|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.18||||0.401|TWO_SIDED|95.0|-0.61|0.25|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||0.25|-0.61|0.401
71112346|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R superior frontal gyrus||||<0.05
71067806|NCT01314872|141644240|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.48||||0.029|TWO_SIDED|95.0|-0.91|-0.05|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.05|-0.91|0.029
71067807|NCT01314872|141644240|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.005|TWO_SIDED|95.0|-1.02|-0.18|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.18|-1.02|0.005
71067808|NCT01314872|141644240|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.58||||0.007|TWO_SIDED|95.0|-1.01|-0.16|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.16|-1.01|0.007
71067809|NCT01314872|141644240|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.34||||0.14|TWO_SIDED|95.0|-0.78|0.11|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||0.11|-0.78|0.140
71067810|NCT01314872|141644241|SUPERIORITY_OR_OTHER||Difference in LS means|-0.18||||0.598|TWO_SIDED|95.0|-0.84|0.49|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||0.49|-0.84|0.598
71067811|NCT01314872|141644241|SUPERIORITY_OR_OTHER||Difference in LS means|-0.67||||0.052|TWO_SIDED|95.0|-1.35|0.01|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||0.01|-1.35|0.052
71067812|NCT01314872|141644241|SUPERIORITY_OR_OTHER||Difference in LS means|-0.76||||0.024|TWO_SIDED|95.0|-1.43|-0.1|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.10|-1.43|0.024
71067813|NCT01314872|141644241|SUPERIORITY_OR_OTHER||Difference in LS means|-1.24|||<|0.001|TWO_SIDED|95.0|-1.9|-0.58|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.58|-1.90|< 0.001
71112347|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L middle frontal gyrus||||<0.05
71112348|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R middle frontal gyrus||||<0.05
71067814|NCT01314872|141644241|SUPERIORITY_OR_OTHER||Difference in LS means|-0.94||||0.007|TWO_SIDED|95.0|-1.62|-0.26|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.26|-1.62|0.007
71112349|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L supplementary motor area (SMA)||||<0.05
71112350|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R SMA||||<0.05
71112351|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L paracentral lobule||||<0.05
71112352|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R paracentral lobule||||<0.05
70938740|NCT04791917|141377942|SUPERIORITY|||||||0.26|||||||ANCOVA|F(1,41) = 1.32, partial eta squared = .03||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on breakpoint for alcohol including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.26
71067815|NCT01314872|141644242|SUPERIORITY_OR_OTHER||Difference in LS means|-0.49|||||TWO_SIDED|95.0|-1.0|0.03||||||||0.03|-1.00|
71067816|NCT01314872|141644242|SUPERIORITY_OR_OTHER||Difference in LS means|-1.1|||||TWO_SIDED|95.0|-1.62|-0.58||||||||-0.58|-1.62|
71067817|NCT01314872|141644243|SUPERIORITY_OR_OTHER||Difference in LS means|-0.29|||||TWO_SIDED|95.0|-0.71|0.13||||||||0.13|-0.71|
71067818|NCT01314872|141644243|SUPERIORITY_OR_OTHER||Difference in LS means|-0.21|||||TWO_SIDED|95.0|-0.64|0.21||||||||0.21|-0.64|
71067819|NCT01314872|141644244|SUPERIORITY_OR_OTHER||Difference in LS means|-0.07|||||TWO_SIDED|95.0|-0.56|0.43||||||||0.43|-0.56|
71067820|NCT01314872|141644244|SUPERIORITY_OR_OTHER||Difference in LS means|0.02|||||TWO_SIDED|95.0|-0.48|0.51||||||||0.51|-0.48|
71067821|NCT01314872|141644245|SUPERIORITY_OR_OTHER||Difference in LS means|-0.76|||||TWO_SIDED|95.0|-1.45|-0.08||||||||-0.08|-1.45|
71067822|NCT01314872|141644245|SUPERIORITY_OR_OTHER||Difference in LS means|-1.24|||||TWO_SIDED|95.0|-1.93|-0.56||||||||-0.56|-1.93|
71067823|NCT02986282|141644274|OTHER||Median Difference (Final Values)|-0.0600326|||<|0.05|TWO_SIDED|95.0|-0.0799661|-0.0449876|||Wilcoxon (Mann-Whitney)|||It was calculated that the study sample size of 79 subjects would be needed to detect a difference of 0.1 in the ABI measured in sinus rhythm and during atrial fibrillation, with a two-tailed α of 0.05 and a (1-β) of 0.90. Our initial estimate of sample size of 115 patients incorporated an assumption of dropout. Intra-observer variability was calculated using intra-class correlation coefficient.||-0.0449876|-0.0799661|<0.05
71067824|NCT02986282|141644275|OTHER||Median Difference (Final Values)|-0.0249837|||<|0.05|TWO_SIDED|95.0|-0.039992|-0.0100226|||Wilcoxon (Mann-Whitney)|||||-0.0100226|-0.039992|<0.05
71067825|NCT00468481|141644299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|384.7|||<|0.0001||95.0|282.42|486.98|||ANCOVA|Analysis of Covariance (ANCOVA) with treatment as factor and Baseline (RBC folate) as covariate|Difference = DRSP/EE/MTHF - YAZ|The null hypothesis was that the difference between DRSP/EE/MTHF and Yaz treatment groups in the RBC folate levels at week 24 was 0.||486.98|282.42|<0.0001
71067826|NCT00468481|141644300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.87|||<|0.0001||95.0|14.04|23.7|||ANCOVA|Analysis of Covariance (ANCOVA) with treatment as factor and Baseline (plasma folate) as covariate|Difference =DRSP/EE/MTHF - YAZ|The null hypothesis was that the difference between DRSP/EE/MTHF and Yaz treatment groups in the plasma folate levels at week 24 was 0.||23.70|14.04|<0.0001
71067827|NCT00734162|141644363|SUPERIORITY_OR_OTHER||||||<|0.001||||||A p-value of \< 0.05 was considered statistically significant.|Cochran-Mantel-Haenszel|||Analysis is the difference between treatment groups in the proportion of participants who met the outcome measure criterion, controlling for randomization age group.||||< 0.001
71067828|NCT00653133|141644402|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Null hypothesis: There is no difference in reported complications associated with the placement of continuous peripheral nerve block catheters between ultrasound imaging guided placement and nerve stimulator guided placement.||||<0.05
71067829|NCT01068730|141644404|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% confidence intervals (CIs) for the test-to-reference ratios (B/A) and (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf.|Ratio (%) of Geometric LS Means|102.58|||||TWO_SIDED|95.0|99.07|106.23|||||Ratio=Treatment B/Treatment A. Geometric least squares (LS) means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the 500-mg or 1000-mg Glucophage tablets manufactured by BMS and 500-mg or 1000-mg Diabex tablets manufactured in Australia by Alphapharm, then 20 subjects would have provided 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would have provided 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||106.23|99.07|
71067830|NCT01068730|141644404|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% confidence intervals (CIs) for the test-to-reference ratios (B/A) and (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf.|Ratio (%) of Geometric LS Means|99.67|||||TWO_SIDED|95.0|96.16|103.31|||||Ratio=Treatment D/Treatment C. Geometric LS means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the 500-mg or 1000-mg Glucophage tablets manufactured by BMS and 500-mg or 1000-mg Diabex tablets manufactured in Australia by Alphapharm, then 20 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would have provided 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||103.31|96.16|
71067831|NCT01068730|141644404|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|7062.8||||||||||||||Geometric least squares means for Treatment A||||
71067832|NCT01068730|141644404|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|7245.2||||||||||||||Geometric least squares means for Treatment B||||
71067833|NCT01068730|141644404|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|11680.0||||||||||||||Geometric least squares means for Treatment C||||
71067834|NCT01068730|141644404|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)]|11641.0||||||95.0||||||||Geometric least squares means for Treatment D||||
71078591|NCT01240902|141665058|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1033|TWO_SIDED|||||Hierarchical test item #5, MACCE at 30 days or hospital discharge; whichever was longer. K-M rates TAVR 8.21%, SAVR 10.93%, Difference -2.73%, Standard Error 2.16%, and Upper 95% CI 1.5%.|Kaplan-Meier Point Estimate|Using Greenwood formula||"Powered Secondary Hypothesis: TAVR with the Medtronic CoreValve System was superior to SAVR in binary rate of MACCE at 30 days or hospital discharge, whichever was longer:~H0: πMCS TAVR = πSAVR HA: πMCS TAVR \< πSAVR In the above expression πMCS TAVR and πSAVR denoted rates of MACCE at 30 days or hospital discharge, whichever was longer.~Assumptions:~1:1 treatment allocation ratio One-sided alpha=0.025 SAVR = 20.0% MCS TAVI = 12.1% Power = \>80%"||||0.1033
70852747|NCT01578850|141194340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75||||0.002|TWO_SIDED|95.0|-2.85|-0.66|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Tender Joint Count: Week 52||-0.66|-2.85|0.002
71067835|NCT01068730|141644405|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% confidence intervals (CIs) for the test-to-reference ratios (B/A) and (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf.|Ratio (%) of Geometric LS Means|101.12|||||TWO_SIDED|95.0|96.36|106.11|||||Ratio=Treatment B/Treatment A. Geometric LS means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the 500-mg or 1000-mg Glucophage tablets manufactured by BMS and 500-mg or 1000-mg Diabex tablets manufactured in Australia by Alphapharm, then 20 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would have provided 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||106.11|96.36|
71067836|NCT01068730|141644405|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% confidence intervals (CIs) for the test-to-reference ratios (B/A) and (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf.|Ratio (%) of Geometric LS Means|98.65|||||TWO_SIDED|95.0|93.94|103.59|||||Ratio=Treatment B/Treatment A. Geometric LS means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the 500-mg or 1000-mg Glucophage tablets manufactured by BMS and 500-mg or 1000-mg Diabex tablets manufactured in Australia by Alphapharm, then 20 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would have provided 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||103.59|93.94|
71067837|NCT01068730|141644405|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|1013.6||||||||||||||Geometric least squares means for Treatment A||||
71067838|NCT01068730|141644405|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|1024.9||||||||||||||Geometric least squares means for Treatment B||||
71067839|NCT01068730|141644405|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|1643.8||||||||||||||Geometric least squares means for Treatment C||||
71067840|NCT01068730|141644405|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|1621.6||||||||||||||Geometric least squares means for Treatment D||||
71067841|NCT01068730|141644415|SUPERIORITY_OR_OTHER||Ratio (%) of Geometric LS Means|103.19|||||TWO_SIDED|95.0|99.75|106.75|||||Ratio=Treatment B/Treatment A. Geometric LS means values are presented in other statistical analysis entries.|||106.75|99.75|
71067842|NCT01068730|141644415|SUPERIORITY_OR_OTHER||Ratio (%) of Geometric LS Means|99.44|||||TWO_SIDED|95.0|96.08|102.92|||||Ratio=Treatment D/Treatment C. Geometric LS means values are presented in other statistical analysis entries.|||102.92|96.08|
71067843|NCT01068730|141644415|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|6907.1||||||||||||||Geometric least squares means for Treatment A||||
71067844|NCT01068730|141644415|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|7127.4||||||95.0||||||||Geometric least squares means for Treatment B||||
71067845|NCT01068730|141644415|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|11391.0||||||||||||||Geometric least squares means for Treatment C||||
71067846|NCT01068730|141644415|SUPERIORITY_OR_OTHER||[Geometric Least Squares Mean (ng*hr/mL)|11327.0||||||||||||||Geometric least squares means for Treatment D||||
71067847|NCT01270464|141644419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.0507||0.0018|TWO_SIDED|95.0|0.06|0.259||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||The primary variable was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.259|0.060|0.0018
71067848|NCT01270464|141644419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.0508||0.0237|TWO_SIDED|95.0|0.016|0.215||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||The primary variable was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.215|0.016|0.0237
71067849|NCT01270464|141644420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.0543||0.0174|TWO_SIDED|95.0|0.023|0.237||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.237|0.023|0.0174
71067850|NCT01270464|141644420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.0543||0.3731|TWO_SIDED|95.0|-0.058|0.155||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.155|-0.058|0.3731
71112353|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R superior parietal lobule||||<0.05
71112354|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R inferior parietal lobule||||<0.05
71112355|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L superior orbital gyrus||||<0.05
71112356|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L middle orbital gyrus||||<0.05
71112357|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R middle orbital gyrus||||<0.05
71112358|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R calcarine gyrus||||<0.05
71112359|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L calcarine gyrus||||<0.05
71112360|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L anterior cingulate cortex||||<0.05
70938741|NCT04791917|141377943|SUPERIORITY|||||||0.11|||||||ANCOVA|F(1,43) = 2.60, partial eta squared = .06||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Omax for alcohol including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.11
70938742|NCT04791917|141377944|SUPERIORITY|||||||0.17|||||||ANCOVA|F(1,42) = 1.95, partial eta squared = .04||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on alcohol Pmax including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.17
70938743|NCT04791917|141377945|SUPERIORITY|||||||0.91|||||||ANCOVA|F(1,43)=.01, partial eta squared = .00||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on alcohol essential value including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.91
71067851|NCT01270464|141644421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.233|STANDARD_ERROR_OF_MEAN|0.1212||0.0552|TWO_SIDED|95.0|-0.005|0.472||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.472|-0.005|0.0552
71067852|NCT01270464|141644421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.1215||0.802|TWO_SIDED|95.0|-0.209|0.27||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.270|-0.209|0.8020
71067853|NCT01270464|141644423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.359|STANDARD_ERROR_OF_MEAN|0.111||0.0014|TWO_SIDED|95.0|-0.577|-0.14||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||-0.140|-0.577|0.0014
71067854|NCT01270464|141644423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.238|STANDARD_ERROR_OF_MEAN|0.1108||0.0329|TWO_SIDED|95.0|-0.456|-0.019||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||-0.019|-0.456|0.0329
71067855|NCT01270464|141644424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.359|STANDARD_ERROR_OF_MEAN|0.1582||0.0241|TWO_SIDED|95.0|0.047|0.67||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.670|0.047|0.0241
71067856|NCT01270464|141644424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|STANDARD_ERROR_OF_MEAN|0.1591||0.0822|TWO_SIDED|95.0|-0.036|0.591||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.591|-0.036|0.0822
71067857|NCT01270464|141644425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.0193||0.016|TWO_SIDED|95.0|0.009|0.085||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.085|0.009|0.0160
71112361|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L middle cingulate cortex||||<0.05
71112362|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R middle cingulate cortex||||<0.05
71112363|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R angular gyrus||||<0.05
70938744|NCT04791917|141377946|SUPERIORITY|||||||0.14|||||||ANCOVA|F(1,41) = 2.24, partial eta squared = .05||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on intensity of cannabis demand including baseline urge to consume cannabis and CUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.14
70941801|NCT04748445|141383937|OTHER||Slope|0.935|STANDARD_ERROR_OF_MEAN|1.289||0.4696|TWO_SIDED|90.0|-1.201|3.071|||Mixed Models Analysis|||MM\_Formant 2 Bandwidth (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^0).||3.071|-1.201|0.4696
71112364|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L thalamus||||<0.05
71112365|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R thalamus||||<0.05
71112366|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L precuneus||||<0.05
71112367|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R precuneus||||<0.05
70938745|NCT04791917|141377947|SUPERIORITY|||||||0.83|||||||ANCOVA|F(1,41) = .04, partial eta squared = .001||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on breakpoint of cannabis demand including baseline urge to consume cannabis and CUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.83
71067858|NCT01270464|141644425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.051|STANDARD_ERROR_OF_MEAN|0.0193||0.0094|TWO_SIDED|95.0|0.012|0.089||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.089|0.012|0.0094
71067859|NCT01270464|141644426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.624|STANDARD_ERROR_OF_MEAN|0.2551||0.0151|TWO_SIDED|95.0|-1.126|-0.121||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||-0.121|-1.126|0.0151
71067860|NCT01270464|141644426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.648|STANDARD_ERROR_OF_MEAN|0.2559||0.0119|TWO_SIDED|95.0|-1.152|-0.144||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||-0.144|-1.152|0.0119
71067861|NCT01270464|141644427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.494|STANDARD_ERROR_OF_MEAN|0.0242||0|TWO_SIDED|95.0|-0.542|-0.447||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Regression, Logistic|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||-0.447|-0.542|0.0000
71067862|NCT01270464|141644427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.323|STANDARD_ERROR_OF_MEAN|0.0243||0|TWO_SIDED|95.0|-0.37|-0.275||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||-0.275|-0.370|0.0000
71067863|NCT01369030|141644433|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.5|STANDARD_DEVIATION|6.3||0|||||||Wilcoxon signed-rank test|||||||0.000
71067864|NCT04075682|141644499|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus their not being equal.|Mean Difference (Net)|0.26|STANDARD_ERROR_OF_MEAN|0.51||0.6|TWO_SIDED|95.0|-0.73|1.25||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.25|-0.73|0.60
71067865|NCT04075682|141644499|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus their not being equal.|Mean Difference (Net)|-0.78|STANDARD_ERROR_OF_MEAN|0.73||0.29|TWO_SIDED|95.0|-2.22|0.66||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.66|-2.22|0.29
71078883|NCT02179749|141665779|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.04||0.038|TWO_SIDED||||||Mixed Models Analysis|||Latent growth model includes one week on study drug and two weeks after the last dose of study drug. Principal predictors were drug plasma concentration and baseline treatment goal of abstinence or non abstinence. Arms were combined for this analysis.||||0.038
70938746|NCT04791917|141377948|SUPERIORITY|||||||0.15|||||||ANCOVA|F(1,41) = 2.20, partial eta squared = .05||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Omax for cannabis including baseline urge to consume cannabis and CUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.15
71067866|NCT04075682|141644499|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.25|STANDARD_ERROR_OF_MEAN|0.72||0.73|TWO_SIDED|95.0|-1.67|1.16||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.16|-1.67|0.73
71067867|NCT04075682|141644499|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|1.04||0.77|TWO_SIDED|95.0|-2.34|1.74||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||1.74|-2.34|0.77
71067868|NCT04075682|141644499|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.73|STANDARD_ERROR_OF_MEAN|1.1||0.51|TWO_SIDED|95.0|-1.43|2.88||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||2.88|-1.43|0.51
71067869|NCT04075682|141644499|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|2.02|STANDARD_ERROR_OF_MEAN|1.02||0.05|TWO_SIDED|95.0|0.02|4.01||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||4.01|0.02|0.05
71067870|NCT04075682|141644499|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.91|STANDARD_ERROR_OF_MEAN|1.49||0.54|TWO_SIDED|95.0|-3.84|2.02||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.02|-3.84|0.54
71067871|NCT04075682|141644499|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|2.02|STANDARD_ERROR_OF_MEAN|1.61||0.21|TWO_SIDED|95.0|-1.13|5.17||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||5.17|-1.13|0.21
71078884|NCT02179749|141665780|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|36.7||0.5|TWO_SIDED||||||ANOVA|411 and 102 degrees of freedom||||||0.50
71112368|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R caudate nucleus||||<0.05
71078885|NCT02756364|141665781|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.537|TWO_SIDED|95.0|0.47|1.26|||Log Rank||HR obtained by stratified Cox proportional hazard model with treatment arm, original interactive response technology (IRT) stratification factors as covariates. A hazard ratio of \<1 was considered statistically significant.|||1.26|0.47|0.537
71078886|NCT02756364|141665781|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.849|TWO_SIDED|95.0|0.53|1.45|||Log Rank||HR obtained by stratified Cox proportional hazard model with treatment arm, original IRT stratification factors as covariates. A hazard ratio of \<1 was considered statistically significant.|||1.45|0.53|0.849
70938747|NCT04791917|141377949|SUPERIORITY|||||||0.24|||||||ANCOVA|F(1,41) = 1.41, partial eta squared = .03||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Omax for cannabis including baseline urge to consume cannabis and CUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.24
70938748|NCT04791917|141377950|SUPERIORITY|||||||0.97|||||||ANCOVA|F(1,41) = .001, partial eta squared = .00||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Essential Value for cannabis including baseline urge to consume cannabis and CUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.97
70938749|NCT04791917|141377950|SUPERIORITY|||||||0.03|||||||ANCOVA|F(1,41) = 4.86, partial eta squared = .11||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Essential Value for cannabis including baseline urge to consume cannabis and CUDIT score as covariates. Here we report the results of the analysis of the Time X Group interaction.||||.03
70938750|NCT04791917|141377951|SUPERIORITY|||||||0.04|||||||ANCOVA|F(1,42) = 4.66, partial eta squared = .10||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on intensity of alcohol demand including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.04
70938751|NCT04791917|141377951|SUPERIORITY||Slope|0.1||||0.26|TWO_SIDED||||||ANCOVA|||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Intensity of alcohol demand including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the effect of Time on Intensity for men in the DOMS group.||||.26
70938752|NCT04791917|141377951|SUPERIORITY||Slope|-0.09||||0.22|TWO_SIDED||||||ANCOVA|||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Intensity of alcohol demand including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the effect of Time on Intensity for women in the DOMS group.||||.22
70938753|NCT04791917|141377951|SUPERIORITY||Slope|-0.1||||0.27|TWO_SIDED||||||ANCOVA|||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Intensity of alcohol demand including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the effect of Time on Intensity for men in the sham DOMS group.||||.27
70938754|NCT04791917|141377951|SUPERIORITY||Slope|0.06||||0.49|TWO_SIDED||||||ANCOVA|||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Intensity of alcohol demand including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the effect of Time on Intensity for women in the sham DOMS group.||||.49
70938755|NCT02790788|141377952|SUPERIORITY||Mean Difference (Net)|3.3|STANDARD_ERROR_OF_MEAN|4.3||0.44|TWO_SIDED|95.0|-5.2|11.8|||t-test, 2 sided|||Independent Samples t-test||11.8|-5.2|0.44
70938756|NCT02790788|141377954|SUPERIORITY||Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|3.6||0.17|TWO_SIDED|95.0|-2.2|12.2|||t-test, 2 sided|||||12.2|-2.2|0.17
70938757|NCT02790788|141377955|SUPERIORITY||Mean Difference (Final Values)|10.6|STANDARD_ERROR_OF_MEAN|5.0||0.043|TWO_SIDED|95.0|0.4|20.8|||t-test, 2 sided|||||20.8|0.4|0.043
71078592|NCT01240902|141665062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.6|STANDARD_DEVIATION|0.9|<|0.0001|TWO_SIDED|||||Hierarchical test item #3, change from baseline to 1 year.|t-test, 2 sided|||Change in NYHA classification from baseline to 1 year from secondary objective #5. The paired t-test will be used to test the null hypothesis that the mean paired difference is zero versus the two-sided alternative that the mean is not zero.||||<0.0001
71112369|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L putamen||||<0.05
70938758|NCT02790788|141377956|SUPERIORITY||Mean Difference (Net)|-2.0|STANDARD_ERROR_OF_MEAN|3.7||0.59|TWO_SIDED|95.0|-9.3|5.3|||t-test, 2 sided|||||5.3|-9.3|0.59
70938759|NCT02790788|141377957|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|2.0||0.64|TWO_SIDED|95.0|-3.1|5.0|||t-test, 2 sided|||||5.0|-3.1|0.64
70938760|NCT02790788|141377958|SUPERIORITY||Mean Difference (Net)|-4.0|STANDARD_ERROR_OF_MEAN|3.0||0.2|TWO_SIDED|95.0|-10.1|2.1|||t-test, 2 sided|||||2.1|-10.1|0.20
70938761|NCT02790788|141377959|SUPERIORITY||Mean Difference (Net)|2.8|STANDARD_ERROR_OF_MEAN|1.9||0.14|TWO_SIDED|95.0|-0.9|6.6|||t-test, 2 sided|||||6.6|-0.9|0.14
70938762|NCT02790788|141377960|SUPERIORITY||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|3.4||0.9|TWO_SIDED|95.0|-6.4|7.3|||t-test, 2 sided|||||7.3|-6.4|0.90
70938763|NCT02790788|141377961|SUPERIORITY||Mean Difference (Net)|2.1|STANDARD_ERROR_OF_MEAN|2.2||0.33|TWO_SIDED|95.0|-2.2|6.4|||t-test, 2 sided|||||6.4|-2.2|0.33
70938764|NCT02790788|141377962|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|2.8||0.92|TWO_SIDED|95.0|-5.3|5.8|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO LVEDA WITHIN 12 HOURS AFTER ROSC||5.8|-5.3|0.92
70938765|NCT02790788|141377962|SUPERIORITY||Mean Difference (Net)|-0.81|STANDARD_ERROR_OF_MEAN|1.3||0.54|TWO_SIDED|95.0|-3.4|1.8|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO RVEDA WITHIN 12 HOURS AFTER ROSC||1.8|-3.4|0.54
70938766|NCT02790788|141377962|SUPERIORITY||Mean Difference (Net)|4.6|STANDARD_ERROR_OF_MEAN|2.17||0.048|TWO_SIDED|95.0|0.04|9.15|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO LVEDA AT 72 HOURS AFTER ROSC||9.15|0.04|0.048
70938767|NCT02790788|141377962|SUPERIORITY||Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|1.4||0.18|TWO_SIDED|95.0|-1.0|4.7|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO RVEDA AT 72 HOURS AFTER ROSC||4.7|-1.0|0.18
70938768|NCT02790788|141377963|SUPERIORITY||Mean Difference (Net)|-3.6|STANDARD_ERROR_OF_MEAN|3.6||0.32|TWO_SIDED|95.0|-10.9|3.7|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO LVEF WITHIN 12 HOURS AFTER ROSC||3.7|-10.9|0.32
70938769|NCT02790788|141377963|SUPERIORITY||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|3.1||0.76|TWO_SIDED|95.0|-7.2|5.3|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO RVEF WITHIN 12 HOURS AFTER ROSC||5.3|-7.2|0.76
70938770|NCT02790788|141377963|SUPERIORITY||Mean Difference (Net)|-4.9|STANDARD_ERROR_OF_MEAN|4.2||0.25|TWO_SIDED|95.0|-13.5|3.7|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO LVEF AT 72 HOURS AFTER ROSC||3.7|-13.5|0.25
70938771|NCT02790788|141377963|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|3.5||0.61|TWO_SIDED|95.0|-9.1|5.5|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO RVEF WITHIN 72 HOURS AFTER ROSC||5.5|-9.1|0.61
71078887|NCT02756364|141665782|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.276|TWO_SIDED|95.0|0.36|1.4|||Log Rank||HR obtained by stratified Cox proportional hazard model with treatment arm, original IRT stratification factors as covariates. A hazard ratio of \<1 was considered statistically significant.|||1.40|0.36|0.276
70938772|NCT02790788|141377964|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.09||0.41|TWO_SIDED|95.0|-0.25|0.11|||t-test, 2 sided|||RESULTS CORRESPOND TO END-DIASTOLIC ECCI WITHIN 12 HOURS OF ROSC.||0.11|-0.25|0.41
70938773|NCT02790788|141377964|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.09||0.38|TWO_SIDED|95.0|-0.26|0.1|||t-test, 2 sided|||RESULTS CORRESPOND TO END-SYSTOLIC ECCI WITHIN 12 HOURS AFTER ROSC.||0.10|-0.26|0.38
70938774|NCT02790788|141377964|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.1||0.46|TWO_SIDED|95.0|-0.29|0.14|||t-test, 2 sided|||RESULTS CORRESPOND TO END-DIASTOLIC ECCI AT 72 HOURS AFTER ROSC.||0.14|-0.29|0.46
70938775|NCT02790788|141377964|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.11||0.34|TWO_SIDED|95.0|-0.33|0.12|||t-test, 2 sided|||RESULTS CORRESPOND TO END-SYSTOLIC ECCI AT 72 HOURS AFTER ROSC.||0.12|-0.33|0.34
70938776|NCT02790788|141377965|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.65||0.9|TWO_SIDED|95.0|-1.5|1.3|||t-test, 2 sided|||||1.3|-1.5|0.90
70938777|NCT02790788|141377966|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.37||0.59|TWO_SIDED|95.0|-0.54|0.94|||t-test, 2 sided|||||0.94|-0.54|0.59
70938778|NCT02790788|141377967|SUPERIORITY||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.38||0.67|TWO_SIDED|95.0|-0.6|0.93|||t-test, 2 sided|||||0.93|-0.60|0.67
70938779|NCT02790788|141377968|SUPERIORITY||Mean Difference (Net)|0.19|STANDARD_ERROR_OF_MEAN|0.41||0.65|TWO_SIDED|95.0|-0.64|1.02|||t-test, 2 sided|||||1.02|-0.64|0.65
70938780|NCT02790788|141377969|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|1.0||0.41|TWO_SIDED|95.0|-1.2|2.8||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 0-6 HOURS AFTER ROSC.|t-test, 2 sided|||||2.8|-1.2|0.41
70938781|NCT02790788|141377969|SUPERIORITY||Mean Difference (Net)|-0.36|STANDARD_ERROR_OF_MEAN|0.28||0.2|TWO_SIDED|95.0|-0.92|0.19|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 12-18 HOURS AFTER ROSC.||0.19|-0.92|0.20
70938782|NCT02790788|141377969|SUPERIORITY||Median Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|0.26||0.07|TWO_SIDED|95.0|-1.0|0.04|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 12-18 HOURS AFTER ROSC.||0.04|-1.00|0.07
70938783|NCT02790788|141377969|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.29||0.36|TWO_SIDED|95.0|-0.85|0.31|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 18-24 HOURS AFTER ROSC.||0.31|-0.85|0.36
70938784|NCT02790788|141377969|SUPERIORITY||Median Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.25||0.54|TWO_SIDED|95.0|-0.66|0.35|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 24-30 HOURS AFTER ROSC.||0.35|-0.66|0.54
70938785|NCT02790788|141377969|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.28||0.62|TWO_SIDED|95.0|-0.69|0.42|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 30-36 HOURS AFTER ROSC.||0.42|-0.69|0.62
70938786|NCT02790788|141377969|SUPERIORITY||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.28||0.6|TWO_SIDED|95.0|-0.71|0.41|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 36-42 HOURS AFTER ROSC.||0.41|-0.71|0.60
70938787|NCT02790788|141377969|SUPERIORITY||Median Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.26||0.54|TWO_SIDED|95.0|-0.69|0.36|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 42-48 HOURS AFTER ROSC.||0.36|-0.69|0.54
70938788|NCT02790788|141377970|SUPERIORITY||Mean Difference (Net)|0.71|STANDARD_ERROR_OF_MEAN|0.87||0.42|TWO_SIDED|95.0|-2.5|1.1|||t-test, 2 sided|||RESULTS CORRESPOND TO CBFI AT 4 HOURS AFTER ROSC AND AT A MEAN MAP LEVEL OF 75.5 MMHG||1.1|-2.5|0.42
70938789|NCT02790788|141377970|SUPERIORITY||Median Difference (Net)|0.68|STANDARD_ERROR_OF_MEAN|0.79||0.4|TWO_SIDED|95.0|-0.94|2.3|||t-test, 2 sided|||RESULTS CORRESPOND TO CBFI AT 4 HOURS AFTER ROSC AND AT A MEAN MAP LEVEL OF 96.0 MMHG||2.30|-0.94|0.40
70938790|NCT02790788|141377970|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|1.15||0.44|TWO_SIDED|95.0|-1.49|3.28|||t-test, 2 sided|||RESULTS CORRESPOND TO CBFI AT 72 HOURS AFTER ROSC AND AT A MEAN MAP LEVEL OF 75.5 MMHG||3.28|-1.49|0.44
70938791|NCT02790788|141377970|SUPERIORITY||Median Difference (Net)|1.15|STANDARD_ERROR_OF_MEAN|1.23||0.36|TWO_SIDED|95.0|-1.4|3.7|||t-test, 2 sided|||RESULTS CORRESPOND TO CBFI AT 72 HOURS AFTER ROSC AND AT A MEAN MAP LEVEL OF 97.0 MMHG||3.70|-1.40|0.36
70938792|NCT02790788|141377971|SUPERIORITY|||||||0.84|||||||Mann Whitney|||||||0.84
70938793|NCT02790788|141377972|SUPERIORITY||Mean Difference (Net)|-0.025|STANDARD_ERROR_OF_MEAN|0.144||0.86|TWO_SIDED|95.0|-0.311|0.262|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-6 AT 4 HOURS AFTER ROSC||0.262|-0.311|0.86
70938794|NCT02790788|141377972|SUPERIORITY||Mean Difference (Net)|-0.064|STANDARD_ERROR_OF_MEAN|0.111||0.56|TWO_SIDED|95.0|-0.287|0.158|||t-test, 2 sided|||RESULTS CORRESPOND TO TNF-α AT 4 HOURS AFTER ROSC||0.158|-0.287|0.56
70938795|NCT02790788|141377972|SUPERIORITY||Mean Difference (Net)|0.034|STANDARD_ERROR_OF_MEAN|0.053||0.52|TWO_SIDED|95.0|-0.071|0.139|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-1β AT 4 HOURS AFTER ROSC||0.139|-0.071|0.52
70938796|NCT02790788|141377972|SUPERIORITY||Mean Difference (Net)|-0.041|STANDARD_ERROR_OF_MEAN|0.107||0.7|TWO_SIDED|95.0|-0.254|0.172|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-8 AT 4 HOURS AFTER ROSC||0.172|-0.254|0.70
70938797|NCT02790788|141377972|SUPERIORITY||Mean Difference (Net)|0.007|STANDARD_ERROR_OF_MEAN|0.167||0.97|TWO_SIDED|95.0|-0.326|0.34|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-10 AT 4 HOURS AFTER ROSC||0.340|-0.326|0.97
70938798|NCT02790788|141377972|SUPERIORITY||Median Difference (Net)|0.067|STANDARD_ERROR_OF_MEAN|0.129||0.61|TWO_SIDED|95.0|-0.192|0.326|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-6 AT 24 HOURS AFTER ROSC||0.326|-0.192|0.61
70938799|NCT02790788|141377972|SUPERIORITY||Mean Difference (Net)|0.014|STANDARD_ERROR_OF_MEAN|0.126||0.91|TWO_SIDED|95.0|-0.238|0.267|||t-test, 2 sided|||RESULTS CORRESPOND TO TNFα AT 24 HOURS AFTER ROSC||0.267|-0.238|0.91
70938800|NCT02790788|141377972|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.03||0.19|TWO_SIDED|95.0|-0.1|0.021|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-1β AT 24 HOURS AFTER ROSC||0.021|-0.100|0.19
70938801|NCT02790788|141377972|SUPERIORITY||Mean Difference (Net)|-0.022|STANDARD_ERROR_OF_MEAN|0.111||0.85|TWO_SIDED|95.0|-0.244|0.201|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-8 AT 24 HOURS AFTER ROSC||0.201|-0.244|0.85
70938802|NCT02790788|141377972|SUPERIORITY||Mean Difference (Net)|0.147|STANDARD_ERROR_OF_MEAN|0.162||0.37|TWO_SIDED|95.0|-0.179|0.473|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-10 AT 24 HOURS AFTER ROSC||0.473|-0.179|0.37
70938803|NCT02790788|141377972|SUPERIORITY||Mean Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.127||0.74|TWO_SIDED|95.0|-0.298|0.212|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-6 AT 48 HOURS AFTER ROSC||0.212|-0.298|0.74
71112370|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L amygdala||||<0.05
70938804|NCT02790788|141377972|SUPERIORITY||Mean Difference (Net)|0.036|STANDARD_ERROR_OF_MEAN|0.14||0.8|TWO_SIDED|95.0|-0.246|0.318|||t-test, 2 sided|||RESULTS CORRESPOND TO ΤΝFα AT 48 HOURS AFTER ROSC||0.318|-0.246|0.80
70938805|NCT02790788|141377972|SUPERIORITY||Mean Difference (Net)|0.056|STANDARD_ERROR_OF_MEAN|0.043||0.2|TWO_SIDED|95.0|-0.03|0.142|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-1β AT 48 HOURS AFTER ROSC||0.142|-0.030|0.20
70938806|NCT02790788|141377972|SUPERIORITY||Mean Difference (Net)|-0.024|STANDARD_ERROR_OF_MEAN|0.111||0.83|TWO_SIDED|95.0|-0.246|0.198|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-8 AT 48 HOURS AFTER ROSC||0.198|-0.246|0.83
70938807|NCT02790788|141377972|SUPERIORITY||Mean Difference (Net)|0.027|STANDARD_ERROR_OF_MEAN|0.124||0.83|TWO_SIDED|95.0|-0.223|0.276|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-10 AT 48 HOURS AFTER ROSC||0.276|-0.223|0.83
71067872|NCT04075682|141644499|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-1.07|STANDARD_ERROR_OF_MEAN|1.48||0.47|TWO_SIDED|95.0|-3.97|1.83||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.83|-3.97|0.47
71067873|NCT04075682|141644500|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.49||0.57|TWO_SIDED|95.0|-0.68|1.24||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.24|-0.68|0.57
71067874|NCT04075682|141644500|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-1.25|STANDARD_ERROR_OF_MEAN|0.71||0.08|TWO_SIDED|95.0|-2.63|0.14||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.14|-2.63|0.08
71067875|NCT04075682|141644500|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.7||0.39|TWO_SIDED|95.0|-1.97|0.77||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment, comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||0.77|-1.97|0.39
71067876|NCT04075682|141644500|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.51|STANDARD_ERROR_OF_MEAN|1.0||0.61|TWO_SIDED|95.0|-1.45|2.47||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||2.47|-1.45|0.61
71112371|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R insula lobe||||<0.05
71112372|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L rolandic operculum||||<0.05
71112373|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L hippocampus||||<0.05
70938808|NCT02790788|141377972|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.161||0.85|TWO_SIDED|95.0|-0.294|0.354|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-6 AT 72 HOURS AFTER ROSC||0.354|-0.294|0.85
70938809|NCT02790788|141377972|SUPERIORITY||Mean Difference (Net)|0.048|STANDARD_ERROR_OF_MEAN|0.145||0.74|TWO_SIDED|95.0|-0.243|0.339|||t-test, 2 sided|||RESULTS CORRESPOND TO ΤΝFα AT 72 HOURS AFTER ROSC||0.339|-0.243|0.74
70938810|NCT02790788|141377972|SUPERIORITY||Median Difference (Net)|0.013|STANDARD_ERROR_OF_MEAN|0.039||0.75|TWO_SIDED|95.0|-0.066|0.091|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-1β AT 72 HOURS AFTER ROSC||0.091|-0.066|0.75
70938811|NCT02790788|141377972|SUPERIORITY||Mean Difference (Net)|-0.045|STANDARD_ERROR_OF_MEAN|0.096||0.64|TWO_SIDED|95.0|-0.238|0.149|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-8 AT 72 HOURS AFTER ROSC||0.149|-0.238|0.64
70938812|NCT02790788|141377972|SUPERIORITY||Mean Difference (Net)|0.179|STANDARD_ERROR_OF_MEAN|0.147||0.23|TWO_SIDED|95.0|-0.116|0.475|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-10 AT 72 HOURS AFTER ROSC||0.475|-0.116|0.23
70938813|NCT02790788|141377973|SUPERIORITY||Percent Difference|4.9||||0.45|TWO_SIDED|95.0|-4.8|14.6|||Fisher Exact|||||14.6|-4.8|0.45
70938814|NCT02790788|141377974|SUPERIORITY||Mann-Whitney U|50903.5||||0.68|TWO_SIDED||||||Mann Whitney|||RESULTS CORRESPOND TO THE NUMBER OF EPISODES OF HYPERGLYCEMIA||||0.68
70938815|NCT02790788|141377974|SUPERIORITY||Mann Whitney U|52188.5||||0.68|TWO_SIDED||||||Mann-Whitney|||RESULTS CORRESPOND TO THE NUMBER OF EPISODES OF HYPERNATREMIA||||0.68
70938816|NCT02790788|141377974|SUPERIORITY||Mann-Whitney U|1128.5||||0.37|TWO_SIDED||||||Mann-Whitney|||RESULTS CORRESPOND TO THE NUMBER OF EPISODES OF INFECTION||||0.37
70938817|NCT00134056|141377975|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04||||0.64|TWO_SIDED|95.0|0.9|1.19|||Log Rank|||The primary analysis was by intention to treat and the Hochberg procedure was used for multiple testing of co-primary endpoints. Assuming a 4 year accrual, 2.5 years of follow-up, and 930 eligible patients, the study was designed to have 87% power to detect a 25% increase from 18.0 months to 22.5 months in median overall survival with a one-sided log rank with alpha of 0.0125.||1.19|0.90|0.64
70938818|NCT00134056|141377976|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.02||||0.81|TWO_SIDED|95.0|0.89|1.16|||Log Rank|||The primary analysis was by intention to treat and the Hochberg procedure was used for multiple testing of co-primary endpoints. Assuming a 4 year accrual, 2.5 years of follow-up, and 930 eligible patients, the study was designed to have 87% power to detect a 25% increase from 6.0 months to 7.5 months in median overall survival with a one-sided log rank with alpha of 0.0125.||1.16|0.89|0.81
70938819|NCT00872339|141377994|SUPERIORITY_OR_OTHER|||||||0.45|||||||Chi-squared|||||||0.45
70938820|NCT00872339|141377996|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<.001
70938821|NCT02312258|141378007|SUPERIORITY||Hazard Ratio (HR)|1.09|||=|0.473|TWO_SIDED|95.0|0.861|1.381|||Log Rank||||"P-value comparing OS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), International Staging System (ISS) stage before initial therapy (stage I or II vs stage III), age (\<75 versus \[vs\] \>=75 years) at randomization, and best response to initial therapy (complete response (CR) or very good partial response (VGPR) vs partial response (PR)).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 versus\[vs\] \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.381|0.861|=0.473
70938822|NCT02312258|141378009|SUPERIORITY||Hazard Ratio (HR)|0.655|||<|0.001|TWO_SIDED|95.0|0.537|0.799|||Log Rank||||"P-value comparing TTP between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|0.799|0.537|<0.001
70938823|NCT02312258|141378010|SUPERIORITY||Hazard Ratio (HR)|0.984|||=|0.893|TWO_SIDED|95.0|0.777|1.246|||Log Rank||||"P-value comparing PFS2 between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.246|0.777|=0.893
70938824|NCT02312258|141378011|SUPERIORITY||Hazard Ratio (HR)|0.777|||=|0.018|TWO_SIDED|95.0|0.631|0.957|||Log Rank||||"P-value comparing TTNT between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|0.957|0.631|=0.018
70938825|NCT02312258|141378012|SUPERIORITY||Hazard Ratio (HR)|1.111|||=|0.462|TWO_SIDED|95.0|0.839|1.47|||Log Rank||||"P-value comparing Time to End of Next Line Therapy between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.470|0.839|=0.462
70938826|NCT02312258|141378013|SUPERIORITY||Hazard Ratio (HR)|1.293|||||TWO_SIDED|95.0|0.968|1.727|||||||Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant.|1.727|0.968|
70941802|NCT04748445|141383937|OTHER||Slope|2.105|STANDARD_ERROR_OF_MEAN|1.231||0.0896|TWO_SIDED|90.0|0.06596|4.145|||Mixed Models Analysis|||MM\_Formant 3 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^0).||4.145|0.06596|0.0896
71112374|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R hippocampus||||<0.05
71112375|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R fusiform gyrus||||<0.05
71067877|NCT04075682|141644500|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|1.07||0.9|TWO_SIDED|95.0|-2.23|1.97||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.97|-2.23|0.90
71112376|NCT03574610|141731547|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R rolandic operculum||||<0.05
71112377|NCT03574610|141731548|OTHER|||||||0.45||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||Voided volume - baseline vs post-treatment||||0.45
71112378|NCT03574610|141731548|OTHER|||||||0.39||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||Voided volume - baseline vs 4 month follow-up||||0.39
71112379|NCT03574610|141731548|OTHER|||||||0.014||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||PVR - baseline vs post-treatment||||0.014
71112380|NCT03574610|141731548|OTHER|||||||0.66||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||PVR - baseline vs 4 month follow-up||||0.66
70938827|NCT02312258|141378016|SUPERIORITY||Hazard Ratio (HR)|0.582|||=|0.001|TWO_SIDED|95.0|0.425|0.796|||Log Rank|||PFS for Participants with Known MRD+ at Study Entry|"P-value comparing PFS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|0.796|0.425|=0.001
70941803|NCT04748445|141383937|OTHER||Slope|1.664|STANDARD_ERROR_OF_MEAN|1.358||0.2227|TWO_SIDED|90.0|-5.864|3.915|||Mixed Models Analysis|||MM\_Formant 3 Bandwidth (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^0. For lower limit it was 10\^-1).||3.915|-5.864|0.2227
71112381|NCT03574610|141731548|OTHER|||||||0.31||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||Bladder capacity - baseline vs post-treatment||||0.31
71112382|NCT03574610|141731548|OTHER|||||||0.001||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||Bladder capacity - baseline vs 4 month follow-up||||0.001
71112383|NCT03574610|141731549|OTHER|||||||0.004||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||% PVR/BC - baseline vs post-treatment||||0.004
71112384|NCT03574610|141731549|OTHER|||||||0.038||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||%PVR/BC - baseline vs 4 month follow-up||||0.038
71112385|NCT03574610|141731550|OTHER|||||||0.19||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||Qmax - baseline vs post-treatment||||0.19
71112386|NCT03574610|141731550|OTHER|||||||0.91||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||Max - baseline vs 4 month follow-up||||0.91
71112387|NCT03574610|141731551|OTHER|||||||0.13||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||Liverpool nomogram percentile - baseline vs post-treatment||||0.13
71112388|NCT03574610|141731551|OTHER|||||||0.26||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||Liverpool nomogram percentile - baseline vs 4 month follow-up||||0.26
71112389|NCT03574610|141731552|OTHER|||||||0.4||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||UDI-6 Q1 - baseline vs post-treatment||||0.40
71112390|NCT03574610|141731552|OTHER|||||||0.086||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||UDI-6 Q1 - baseline vs 4 month follow-up||||0.086
71112391|NCT03574610|141731552|OTHER|||||||0.54||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test.||UDI-6 Q2 - baseline vs post-treatment||||0.54
71112392|NCT03574610|141731552|OTHER|||||||0.19||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||UDI-6 Q2 - baseline vs 4 month follow-up||||0.19
71112393|NCT03574610|141731552|OTHER|||||||0.04||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||UDI-6 Q5 - baseline vs post-treatment||||0.04
71112394|NCT03574610|141731552|OTHER|||||||0.026||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||UDI-6 5 - baseline vs 4 month follow-up||||0.026
71112395|NCT03574610|141731553|OTHER|||||||0.044||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||AUASS Q3 - baseline vs post-treatment||||0.044
71112396|NCT03574610|141731553|OTHER|||||||0.017||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||AUASS Q3 - baseline vs 4 month follow-up||||0.017
70938828|NCT02312258|141378016|SUPERIORITY||Hazard Ratio (HR)|1.537|||=|0.398|TWO_SIDED|95.0|0.563|4.194|||Log Rank|||PFS for Participants with Known MRD- at Study Entry|"P-value comparing PFS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|4.194|0.563|=0.398
70938829|NCT02312258|141378016|SUPERIORITY||Hazard Ratio (HR)|10.173|||=|0.012|TWO_SIDED|95.0|1.194|86.649|||Log Rank|||OS for Participants with Known MRD Status (MRD- Status, MRD+ Status) at Study Entry|"P-value comparing OS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|86.649|1.194|=0.012
70938830|NCT02312258|141378018|SUPERIORITY||Hazard Ratio (HR)|1.011|||=|0.963|TWO_SIDED|95.0|0.631|1.621|||Log Rank||||"P-value comparing PFS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.621|0.631|=0.963
70938831|NCT02312258|141378022|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.001|TWO_SIDED|95.0|0.387|0.727|||Log Rank|||PFS Based on Frailty Status of Fit|"P-value comparing PFS between treatment groups was based on Log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\<75 vs \>=75 years) at randomization.~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\<75 vs \>=75 years) at randomization, comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|0.727|0.387|<0.001
70938832|NCT02312258|141378022|SUPERIORITY||Hazard Ratio (HR)|0.746|||=|0.098|TWO_SIDED|95.0|0.526|1.058|||Log Rank|||PFS Based on Frailty Status of Unfit|"P-value comparing PFS between treatment groups was based on Log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\<75 vs \>=75 years) at randomization.~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\<75 vs \>=75 years) at randomization, comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.058|0.526|=0.098
70938833|NCT02312258|141378022|SUPERIORITY||Hazard Ratio (HR)|0.733|||=|0.147|TWO_SIDED|95.0|0.481|1.117|||Log Rank|||PFS Based on Frailty Status of Frail|"P-value comparing PFS between treatment groups was based on Log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\<75 vs \>=75 years) at randomization.~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\<75 vs \>=75 years) at randomization, comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.117|0.481|=0.147
70941804|NCT04748445|141383938|OTHER||Slope|-4.024|STANDARD_ERROR_OF_MEAN|3.122||0.8977|TWO_SIDED|90.0|-5.577|4.772|||Mixed Models Analysis|||EE\_Voiced Frames (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, and dispersion value it was 10\^-3. For estimated value it was 10\^-4).||4.772|-5.577|0.8977
71067878|NCT04075682|141644500|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|2.05|STANDARD_ERROR_OF_MEAN|0.98||0.04|TWO_SIDED|95.0|0.13|3.97||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||3.97|0.13|0.04
71078888|NCT02756364|141665782|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.47|TWO_SIDED|95.0|0.47|1.68|||Log Rank||HR obtained by stratified Cox proportional hazard model with treatment arm, original IRT stratification factors as covariates. A hazard ratio of \<1 was considered statistically significant.|||1.68|0.47|0.470
71112397|NCT03574610|141731553|OTHER|||||||0.54||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||AUASS Q5 - baseline vs post-treatment||||0.54
71112398|NCT03574610|141731553|OTHER|||||||0.503||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||AUASS Q5 - baseline vs 4 month follow-up||||0.503
70938834|NCT02312258|141378022|SUPERIORITY||Hazard Ratio (HR)|0.897|||=|0.714|TWO_SIDED|95.0|0.502|1.602|||Log Rank|||OS Based on Frailty Status of Fit|"P-value comparing OS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.602|0.502|=0.714
70938835|NCT02312258|141378022|SUPERIORITY||Hazard Ratio (HR)|1.75|||=|0.124|TWO_SIDED|95.0|0.85|3.601|||Log Rank|||OS Based on Frailty Status of Unfit|"P-value comparing OS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|3.601|0.850|=0.124
70941805|NCT04748445|141383938|OTHER||Slope|-0.0006624|STANDARD_ERROR_OF_MEAN|7.961||0.407|TWO_SIDED|90.0|-0.001982|0.0006569|||Mixed Models Analysis|||MM\_Voiced Frames (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0006569|-0.001982|0.4070
71067879|NCT04075682|141644500|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.67|STANDARD_ERROR_OF_MEAN|1.43||0.64|TWO_SIDED|95.0|-2.14|3.48||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||3.48|-2.14|0.64
71078593|NCT01240902|141665062|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin= 0.375. For subjects with NYHA categories at both baseline and 1 year visit, the NYHA classification improvements were calculated as NYHAbaseline - NYHA1year.|||||<|0.0001|TWO_SIDED|||||Hierarchical test item #3, change from baseline to 1 year.|t-test, 1 sided|||"Change in NYHA classification from baseline to 1 year: TAVR vs. SAVR from secondary objective #5. The one-sided two-sample t-test was used to test non-inferiority at a level 0.05 the hypotheses:~H0: µ MCS TAVR ≤ µ SAVR -0.375 HA: µ MCS TAVR \> µ SAVR -0.375 In the above expression µ MCS TAVR and µ SAVR denoted the mean number of classification improvements in NYHA from baseline to 1 year."||||<0.0001
71112399|NCT03574610|141731553|OTHER|||||||0.023||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||AUASS Q7 - baseline vs post-treatment||||0.023
71112400|NCT03574610|141731553|OTHER|||||||0.049||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||AUASS Q7 - baseline vs 4 month follow-up||||0.049
71112401|NCT03574610|141731553|OTHER|||||||0.089||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||AUASS Q8 - baseline vs post-treatment||||0.089
71112402|NCT03574610|141731553|OTHER|||||||0.161||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||AUASS Q8 - baseline vs 4 month follow-up||||0.161
71112403|NCT03574610|141731554|OTHER|||||||0.01||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||NBSS (Incontinence) - baseline vs post-treatment||||0.010
71112404|NCT03574610|141731554|OTHER|||||||0.41||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||NBSS (Incontinence) - baseline vs 4 month follow-up||||0.41
71112405|NCT03574610|141731554|OTHER|||||||0.32||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||NBSS (Storage and Voiding) - baseline vs post-treatment||||0.32
71112406|NCT03574610|141731554|OTHER|||||||0.02||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||NBSS (Storage and Voiding) - baseline vs 4 month follow-up||||0.02
71112407|NCT03574610|141731554|OTHER|||||||0.34||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||NBSS (Consequences) - baseline vs post-treatment||||0.34
71112408|NCT03574610|141731554|OTHER|||||||0.61||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||NBSS (Consequences) - baseline vs 4 month follow-up||||0.61
71112409|NCT03574610|141731554|OTHER|||||||0.02||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||NBSS (QoL) - baseline vs post-treatment||||0.02
71112410|NCT03574610|141731554|OTHER|||||||0.07||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||NBSS (QoL) - baseline vs 4 month follow-up||||0.07
71112411|NCT01032954|141731555|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||P-value threshold for significance: \<0.05|GLM= GENERAL LINEAR MODELS WITH REPEATED|||||||<0.05
71112412|NCT01032954|141731556|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||P-value threshold for significance: \<0.05|GLM|||||||<0.05
71112413|NCT03980743|141731563|SUPERIORITY|||||||0.97|||||||Mixed Models Analysis|||Time x treatment (week 0 and week 24)||||0.97
71112414|NCT03980743|141731564|SUPERIORITY|||||||0.273|||||||Mixed Models Analysis|||Time x treatment (week 0 and week 24) for Healthy Eating||||0.273
71112415|NCT03980743|141731565|SUPERIORITY|Time x treatment (week 0 and week 24) with sum score||||||0.691|||||||Mixed Models Analysis|||||||0.691
71067880|NCT04075682|141644500|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|1.56||0.92|TWO_SIDED|95.0|-2.91|3.2||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||3.20|-2.91|0.92
71112416|NCT02263326|141731583|NON_INFERIORITY|We considered DTG/3TC was noninferior to cART if the 90% confidence interval for the difference in proportions, calculated with Miettinen-Nurminen (score) confidence limits, excluded the 12% noninferiority margin.|Risk Difference (RD)|0.0015|||||TWO_SIDED|90.0|-0.098|0.102||||||A sample size of 41 participants per arm provided 80% power to show noninferiority of DTG/3TC to cART based on a 12% noninferiority margin, assuming an estimated treatment failure rate of 5% per arm by week 24 and 5% 1-sided type I error rate.||0.102|-0.098|
71112417|NCT02263326|141731584|NON_INFERIORITY|The difference in virologic outcomes based on the FDA snapshot algorithm at week 48 (HIV RNA \<50 copies/mL) was compared between arms, with 95% confidence intervals.|Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.126|0.165||||||||0.165|-0.126|
71112418|NCT02263326|141731585|OTHER|||||||0.866|||||||Wilcoxon (Mann-Whitney)|||||||0.866
71112419|NCT02263326|141731586|OTHER|||||||0.613|||||||Wilcoxon (Mann-Whitney)|||||||0.613
71112420|NCT02263326|141731587|OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.420
71112421|NCT02263326|141731588|OTHER|||||||0.074|||||||Wilcoxon (Mann-Whitney)|||||||0.074
71112422|NCT02263326|141731590|OTHER||Mean Difference (Final Values)|0.5||||0.76|TWO_SIDED|95.0|-3.0|4.1|||Regression, Linear|||||4.1|-3.0|0.76
71112423|NCT02397915|141731591|SUPERIORITY_OR_OTHER||||||<|0.001||||||Par. preferences were analyzed using Prescott's test, as approximated by a Cochran-Mantel-Haenszel test, adjusted for country and symptomatology. All preference p-values were also adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||<0.001
71112424|NCT02397915|141731592|SUPERIORITY_OR_OTHER|||||||0.065||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute scent/odor.|Cochran-Mantel-Haenszel|||||||0.065
71112425|NCT02397915|141731592|SUPERIORITY_OR_OTHER|||||||0.532||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute immediate taste.|Cochran-Mantel-Haenszel|||||||0.532
71112426|NCT02397915|141731592|SUPERIORITY_OR_OTHER|||||||0.138||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute after taste.|Cochran-Mantel-Haenszel|||||||0.138
71112427|NCT02397915|141731592|SUPERIORITY_OR_OTHER||||||<|0.001||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute LDTT.|Cochran-Mantel-Haenszel|||||||<0.001
71112428|NCT02397915|141731592|SUPERIORITY_OR_OTHER|||||||0.017||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute LRON.|Cochran-Mantel-Haenszel|||||||0.017
71112429|NCT02397915|141731592|SUPERIORITY_OR_OTHER|||||||0.046||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute more soothing.|Cochran-Mantel-Haenszel|||||||0.046
71112430|NCT02397915|141731592|SUPERIORITY_OR_OTHER||||||<|0.001||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute less irritating.|Cochran-Mantel-Haenszel|||||||<0.001
71112431|NCT02397915|141731592|SUPERIORITY_OR_OTHER|||||||0.532||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute UTS.|Cochran-Mantel-Haenszel|||||||0.532
71112432|NCT02397915|141731593|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||1||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||1.000
71067881|NCT04075682|141644500|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-2.25|STANDARD_ERROR_OF_MEAN|1.41||0.11|TWO_SIDED|95.0|-5.02|0.52||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||0.52|-5.02|0.11
71067882|NCT04075682|141644501|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.59||0.57|TWO_SIDED|95.0|-1.48|0.82||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.82|-1.48|0.57
71067883|NCT04075682|141644501|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.97|STANDARD_ERROR_OF_MEAN|1.14||0.39|TWO_SIDED|95.0|-3.22|1.27||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial warnings (averaged over insert) vs no pictorial warnings (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4)||1.27|-3.22|0.39
71067884|NCT04075682|141644501|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|1.63||0.92|TWO_SIDED|95.0|-3.35|3.04||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||3.04|-3.35|0.92
71067885|NCT04075682|141644502|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.48||0.4|TWO_SIDED|95.0|-1.33|0.53||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.53|-1.33|0.40
71067886|NCT04075682|141644502|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.94||0.99|TWO_SIDED|95.0|-1.83|1.86||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial health warning labels (HWLs) (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||1.86|-1.83|0.99
71067887|NCT04075682|141644502|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.85|STANDARD_ERROR_OF_MEAN|1.34||0.17|TWO_SIDED|95.0|-0.78|4.48||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||4.48|-0.78|0.17
71078594|NCT01240902|141665065|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Hierarchical test item #4|t-test, 2 sided|||Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline to 1 year from secondary objective #8. The paired t-test will be used to test the null hypothesis that the mean paired difference is zero versus the two-sided alternative that the mean is not zero.||||<0.0001
70941806|NCT04748445|141383939|OTHER||Slope|0.0008654|STANDARD_ERROR_OF_MEAN|1.441||0.5491|TWO_SIDED|90.0|-0.001522|0.003253|||Mixed Models Analysis|||EE\_Jitter Local (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.003253|-0.001522|0.5491
71067888|NCT04075682|141644503|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.44|STANDARD_ERROR_OF_MEAN|0.58||0.45|TWO_SIDED|95.0|-0.69|1.57||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.57|-0.69|0.45
71067889|NCT04075682|141644503|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|0.58||0.41|TWO_SIDED|95.0|-1.61|0.66||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.66|-1.61|0.41
71067890|NCT04075682|141644503|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-1.44|STANDARD_ERROR_OF_MEAN|0.84||0.08|TWO_SIDED|95.0|-3.08|0.2||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.20|-3.08|0.08
71067891|NCT04075682|141644503|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.82||0.52|TWO_SIDED|95.0|-2.14|1.09||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.09|-2.14|0.52
71067892|NCT04075682|141644503|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|1.11||0.75|TWO_SIDED|95.0|-1.82|2.51||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||2.51|-1.82|0.75
71112433|NCT02397915|141731594|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||1||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||1.00
71112434|NCT02397915|141731595|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||1||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||1.00
71112435|NCT02397915|141731596|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.179||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.179
71112436|NCT02397915|141731597|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||1||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||1.00
71112437|NCT02397915|141731598|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|||<|0.001||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||<0.001
71112438|NCT02397915|141731599|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|||<|0.001||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||<0.001
71067893|NCT04075682|141644503|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.74|STANDARD_ERROR_OF_MEAN|1.57||0.64|TWO_SIDED|95.0|-3.82|2.33||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||2.33|-3.82|0.64
70941807|NCT04748445|141383939|OTHER||Slope|-2.206|STANDARD_ERROR_OF_MEAN|3.176||0.9447|TWO_SIDED|90.0|-5.483|5.042|||Mixed Models Analysis|||MM\_Jitter Local (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, and dispersion value it was 10\^-3. For estimated value it was 10\^-4).||5.042|-5.483|0.9447
71067894|NCT04075682|141644503|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|1.18||0.91|TWO_SIDED|95.0|-2.17|2.45||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||2.45|-2.17|0.91
71067895|NCT04075682|141644503|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.84|STANDARD_ERROR_OF_MEAN|1.25||0.5|TWO_SIDED|95.0|-3.29|1.6||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.60|-3.29|0.50
71067896|NCT04075682|141644503|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|3.14|STANDARD_ERROR_OF_MEAN|1.16||0.007|TWO_SIDED|95.0|0.86|5.41||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||5.41|0.86|0.007
71067897|NCT04075682|141644503|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.09|STANDARD_ERROR_OF_MEAN|1.69||0.52|TWO_SIDED|95.0|-2.22|4.4||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||4.40|-2.22|0.52
71067898|NCT04075682|141644503|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|1.82||0.86|TWO_SIDED|95.0|-3.89|3.23||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||3.23|-3.89|0.86
71067899|NCT04075682|141644503|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.86|STANDARD_ERROR_OF_MEAN|1.68||0.61|TWO_SIDED|95.0|-4.15|2.43||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.43|-4.15|0.61
71067900|NCT04075682|141644504|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.26|STANDARD_ERROR_OF_MEAN|0.28||0.29|TWO_SIDED|95.0|0.82|1.96||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.96|0.82|0.29
71067901|NCT04075682|141644504|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.19|STANDARD_ERROR_OF_MEAN|0.27||0.43|TWO_SIDED|95.0|0.77|1.85||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||1.85|0.77|0.43
71067902|NCT04075682|141644504|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.18|STANDARD_ERROR_OF_MEAN|0.37||0.6|TWO_SIDED|95.0|0.63|2.2||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||2.20|0.63|0.60
71067903|NCT04075682|141644504|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.25|STANDARD_ERROR_OF_MEAN|0.4||0.48|TWO_SIDED|95.0|0.67|2.33||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||2.33|0.67|0.48
71067904|NCT04075682|141644504|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.8|STANDARD_ERROR_OF_MEAN|0.36||0.62|TWO_SIDED|95.0|0.34|1.91||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||1.91|0.34|0.62
71067905|NCT04075682|141644504|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|3.04|STANDARD_ERROR_OF_MEAN|1.93||0.079|TWO_SIDED|95.0|0.88|10.52||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||10.52|0.88|0.079
71067906|NCT04075682|141644504|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.1|STANDARD_ERROR_OF_MEAN|0.95||0.1|TWO_SIDED|95.0|0.87|5.12||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||5.12|0.87|0.10
71078595|NCT01240902|141665065|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin 5||||||0.0063|TWO_SIDED|||||Hierarchical test item #4|t-test, 1 sided|||"Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline to 1 year: TAVR vs. SAVR from secondary objective #8. The one-sided two-sample t-test was used to test non-inferiority at a level 0.05 the hypotheses:~H0: µ MCS TAVR ≤ µ SAVR -5 HA: µ MCS TAVR \> µ SAVR -5 In the above expression µ MCS TAVR and µ SAVR denoted the mean improvements in the KCCQ score from baseline to 1 year."||||0.0063
71067907|NCT04075682|141644504|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.38|STANDARD_ERROR_OF_MEAN|0.68||0.52|TWO_SIDED|95.0|0.52|3.61||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||3.61|0.52|0.52
71067908|NCT04075682|141644504|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.32|STANDARD_ERROR_OF_MEAN|0.59||0.54|TWO_SIDED|95.0|0.55|3.17||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||3.17|0.55|0.54
71067909|NCT04075682|141644504|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.88|STANDARD_ERROR_OF_MEAN|1.21||0.33|TWO_SIDED|95.0|0.53|6.61||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||6.61|0.53|0.33
71067910|NCT04075682|141644504|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.53|STANDARD_ERROR_OF_MEAN|1.08||0.55|TWO_SIDED|95.0|0.38|6.11||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||6.11|0.38|0.55
71067911|NCT04075682|141644504|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.61|STANDARD_ERROR_OF_MEAN|0.39||0.44|TWO_SIDED|95.0|0.18|2.14||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.14|0.18|0.44
71112439|NCT02397915|141731600|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||1||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||1.000
71112440|NCT02397915|141731601|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.188||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.188
71112441|NCT02397915|141731602|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.951||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.951
71112442|NCT02397915|141731603|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.951||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.951
71112443|NCT02397915|141731604|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.951||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.951
71112444|NCT02397915|141731605|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.004||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.004
71112445|NCT02397915|141731606|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.223||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.223
71067912|NCT04075682|141644504|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.29|STANDARD_ERROR_OF_MEAN|0.28||0.251|TWO_SIDED|95.0|0.84|1.98||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the multiple imputation models for pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.98|0.84|0.2510
70941808|NCT04748445|141383940|OTHER||Slope|0.007567|STANDARD_ERROR_OF_MEAN|1.12||0.5004|TWO_SIDED|90.0|-0.01099|0.02612|||Mixed Models Analysis|||EE\_Shimmer Local (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.02612|-0.01099|0.5004
71067913|NCT04075682|141644504|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.27|STANDARD_ERROR_OF_MEAN|0.28||0.2822|TWO_SIDED|95.0|0.82|1.95||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the multiple imputation model for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||1.95|0.82|0.2822
71067914|NCT04075682|141644504|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.34|STANDARD_ERROR_OF_MEAN|0.42||0.3558|TWO_SIDED|95.0|0.72|2.47||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for multiple imputation models for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||2.47|0.72|0.3558
71067915|NCT04075682|141644504|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.36|STANDARD_ERROR_OF_MEAN|0.43||0.3291|TWO_SIDED|95.0|0.73|2.51||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the multiple imputation model for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||2.51|0.73|0.3291
71067916|NCT04075682|141644504|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.89|STANDARD_ERROR_OF_MEAN|0.39||0.7818|TWO_SIDED|95.0|0.38|2.09||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||2.09|0.38|0.7818
71078596|NCT01240902|141665065|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Hierarchical test item #6. Item #5 failed, therefore, item #6 also fails. Nominal p- value provided.|t-test, 2 sided|||"Change in SF-12 Physical Summary Scale from baseline to 30 days: TAVR vs. SAVR from secondary objective #8. The two-sided two-sample t-test was used to test at a level 0.05 the hypotheses:~H0: µ MCS TAVR = µ SAVR HA: µ MCS TAVR ≠ µ SAVR In the above expression µ MCS TAVR and µ SAVR denoted the mean improvements in the SF-12 Physical Summary Scale from baseline to 30 days."||||<0.0001
71078889|NCT02756364|141665783|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.495|TWO_SIDED|95.0|0.46|1.25|||Log Rank||HR obtained by stratified Cox proportional hazard model with treatment arm, original IRT stratification factors as covariates. A hazard ratio of \<1 was considered statistically significant.|||1.25|0.46|0.495
71078890|NCT02756364|141665783|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.646|TWO_SIDED|95.0|0.49|1.38|||Log Rank||HR obtained by stratified Cox proportional hazard model with treatment arm, original IRT stratification factors as covariates. A hazard ratio of \<1 was considered statistically significant.|||1.38|0.49|0.646
71078891|NCT02756364|141665784|SUPERIORITY||Odds Ratio (OR)|2.23|||||TWO_SIDED|95.0|0.68|7.29|||||The odds ratio and 95% CIs were obtained using a stratified Cochran-Mantel-Haenszel model with the original IRT stratification factors (visceral metastases, previous sensitivity to hormonal therapy, and previous exposure to CDK4/6 inhibitors).|||7.29|0.68|
71078892|NCT02756364|141665784|SUPERIORITY||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.34|4.39|||||The odds ratio and 95% CIs were obtained using a stratified Cochran-Mantel-Haenszel model with the original IRT stratification factors (visceral metastases, previous sensitivity to hormonal therapy, and previous exposure to CDK4/6 inhibitors).|||4.39|0.34|
71078893|NCT02756364|141665785|SUPERIORITY||Odds Ratio (OR)|2.56|||||TWO_SIDED|95.0|0.94|6.94|||||The odds ratio and 95% CIs were obtained using a stratified Cochran-Mantel-Haenszel model with the original IRT stratification factors (visceral metastases, previous sensitivity to hormonal therapy, and previous exposure to CDK4/6 inhibitors).|||6.94|0.94|
71067917|NCT04075682|141644504|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.87|STANDARD_ERROR_OF_MEAN|1.79||0.0912|TWO_SIDED|95.0|0.84|9.73||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||9.73|0.84|0.0912
70941809|NCT04748445|141383940|OTHER||Slope|0.00606|STANDARD_ERROR_OF_MEAN|1.101||0.5831|TWO_SIDED|90.0|-0.01219|0.02431|||Mixed Models Analysis|||MM\_Shimmer Local (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.02431|-0.01219|0.5831
71067918|NCT04075682|141644504|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.94|STANDARD_ERROR_OF_MEAN|0.87||0.1361|TWO_SIDED|95.0|0.81|4.66||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||4.66|0.81|0.1361
71067919|NCT04075682|141644504|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.19|STANDARD_ERROR_OF_MEAN|0.58||0.72|TWO_SIDED|95.0|0.46|3.07||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||3.07|0.46|0.7200
71067920|NCT04075682|141644504|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.48|STANDARD_ERROR_OF_MEAN|0.66||0.3737|TWO_SIDED|95.0|0.62|3.53||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||3.53|0.62|0.3737
71067921|NCT04075682|141644504|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.58|STANDARD_ERROR_OF_MEAN|1.63||0.1345|TWO_SIDED|95.0|0.75|8.9||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||8.90|0.75|0.1345
71078597|NCT01240902|141665066|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Hierarchical test item #2|t-test, 2 sided|||"EOA:~Change in effective orifice area from Baseline to 1 year from secondary objective #9. The paired t-test will be used to test the null hypothesis that the mean paired difference is zero versus the two-sided alternative that the mean is not zero."||||<0.0001
71078598|NCT01240902|141665066|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin 0.375|||||<|0.0001|TWO_SIDED|||||Hierarchical test item #2|t-test, 1 sided|||"EOA:~Change in effective orifice area from Baseline to 1 year: TAVR vs.SAVR from secondary objective #9. The one-sided two-sample t-test was used to test non-inferiority at a level 0.05 the hypotheses:~H0: µ MCS TAVR ≤ µ SAVR -0.375 HA: µ MCS TAVR \> µ SAVR -0.375 In the above expression µ MCS TAVR and µ SAVR denoted the mean improvements in effective orifice area from Baseline to 1 year measured in cm2."||||<0.0001
71078599|NCT01240902|141665067|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Hierarchical test item #1|t-test, 2 sided|||"Transvalvular Mean Gradient:~Change in transvalvular mean gradient from baseline to 1 year from secondary objective #9. The paired t-test will be used to test the null hypothesis that the mean paired difference is zero versus the two-sided alternative that the mean is not zero."||||<0.0001
70941810|NCT04748445|141383941|OTHER||Slope|2.13|STANDARD_ERROR_OF_MEAN|3.211|<|0.0001|TWO_SIDED|90.0|1.598|2.662|||Mixed Models Analysis|||READ\_Speaking Rate (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, and estimated value it was 10\^-2. For dispersion value it was 10\^-3).||2.662|1.598|<.0001
70941811|NCT01855997|141383953|SUPERIORITY_OR_OTHER|||||||5.59e-06|TWO_SIDED||||||t-test, 2 sided|||rs1876154||||0.00000559
71067922|NCT04075682|141644504|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.96|STANDARD_ERROR_OF_MEAN|1.36||0.3318|TWO_SIDED|95.0|0.5|7.67||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||7.67|0.50|0.3318
71067923|NCT04075682|141644504|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.79|STANDARD_ERROR_OF_MEAN|0.49||0.7017|TWO_SIDED|95.0|0.23|2.7||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.70|0.23|0.7017
71067924|NCT04075682|141644505|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.47|STANDARD_ERROR_OF_MEAN|0.7||0.001|TWO_SIDED|95.0|1.42|4.31||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||4.31|1.42|0.001
71078600|NCT01240902|141665067|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin 15|||||<|0.0001|TWO_SIDED|||||Hierarchical test item #1|t-test, 1 sided|||"Transvalvular Mean Gradient:~Change in transvalvular mean gradient from baseline to 1 year: TAVR vs.SAVR from secondary objective #9. The one-sided two-sample t-test was used to test non-inferiority at a level of 0.05 the hypotheses: H0: μ MCS TAVR ≤ μ SAVR -15 HA: μ MCS TAVR \> μ SAVR -15 In the above expression μ MCS TAVR and μ SAVR denoted the mean improvements in mean gradient from Baseline to 1 year measured in mmHg."||||<0.0001
71112446|NCT02397915|141731607|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|||<|0.001||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||<0.001
71112447|NCT02397915|141731608|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.008||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.008
71112448|NCT02397915|141731609|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.831||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.831
71112449|NCT02397915|141731610|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|||<|0.001||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||<0.001
71112450|NCT02397915|141731611|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.007||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.007
71112451|NCT02397915|141731612|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.568||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.568
71112452|NCT02397915|141731613|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.951||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.951
71112453|NCT04551963|141731718|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.49|||||TWO_SIDED|90.0|0.42|0.56||||||Arm A: Zanubrutinib alone vs. Zanubrutinib + fluconazole||0.56|0.42|
71112454|NCT04551963|141731718|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.42|||||TWO_SIDED|90.0|0.34|0.51||||||Arm a: Zanubrutinib alone vs. Zanubrutinib + diltiazem||0.51|0.34|
71112455|NCT04551963|141731719|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.81|||||TWO_SIDED|90.0|0.66|0.99||||||Arm B: Zanubrutinib alone vs. zanubrutinib + voriconazole||0.99|0.66|
70938836|NCT02312258|141378022|SUPERIORITY||Hazard Ratio (HR)|0.854|||=|0.63|TWO_SIDED|95.0|0.448|1.627|||Log Rank|||OS Based on Frailty Status of Frail|"P-value comparing OS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.627|0.448|=0.630
71067925|NCT04075682|141644505|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.89|STANDARD_ERROR_OF_MEAN|0.54||0.025|TWO_SIDED|95.0|1.09|3.3||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||3.30|1.09|0.025
71067926|NCT04075682|141644505|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.37|STANDARD_ERROR_OF_MEAN|0.56||0.44|TWO_SIDED|95.0|0.62|3.06||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||3.06|0.62|0.44
71067927|NCT04075682|141644505|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.8|STANDARD_ERROR_OF_MEAN|0.73||0.15|TWO_SIDED|95.0|0.81|3.97||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||3.97|0.81|0.15
71067928|NCT04075682|141644505|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.19|STANDARD_ERROR_OF_MEAN|0.67||0.76|TWO_SIDED|95.0|0.39|3.58||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||3.58|0.39|0.76
71067929|NCT04075682|141644505|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.79|STANDARD_ERROR_OF_MEAN|0.63||0.77|TWO_SIDED|95.0|0.16|3.8||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||3.80|0.16|0.77
71067930|NCT04075682|141644505|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.18|STANDARD_ERROR_OF_MEAN|1.23||0.17|TWO_SIDED|95.0|0.72|6.61||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||6.61|0.72|0.17
71078601|NCT01441245|141665084|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.04|TWO_SIDED||||||t-test, 2 sided|||Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values \<0.05 were considered significant.||||0.04
70938837|NCT03905512|141378117|SUPERIORITY|Statistical significance was tested at a level of 0.05.||||||0.181|||||||Cochran-Mantel-Haenszel|||||||0.181
70938838|NCT05062343|141378137|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
70938839|NCT05062343|141378138|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
70938840|NCT05062343|141378139|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
70938841|NCT05062343|141378140|SUPERIORITY|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
70938842|NCT05062343|141378141|SUPERIORITY|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||||||0.98
70938843|NCT05062343|141378142|SUPERIORITY|||||||0.045|||||||Chi-squared|||||||0.045
70938844|NCT05062343|141378143|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
70938845|NCT05062343|141378144|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
70938846|NCT00267774|141378200|OTHER||||||<|0.0001||||||A 2-sided value of P\<0.05 was considered to indicate statistical significance.|t-test, 2 sided|||||||<0.0001
70938847|NCT03444298|141378201|SUPERIORITY|||||||0.67||||||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||||0.67
70938848|NCT03444298|141378202|SUPERIORITY|||||||0.43||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.43
71067931|NCT04075682|141644505|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.46|STANDARD_ERROR_OF_MEAN|0.29||0.22|TWO_SIDED|95.0|0.14|1.57||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.57|0.14|0.22
70938849|NCT03444298|141378203|SUPERIORITY|||||||0.27||||||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||||0.27
70938850|NCT03444298|141378204|SUPERIORITY|||||||0.92||||||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||||0.92
70938851|NCT03444298|141378205|SUPERIORITY|||||||0.99||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.99
70938852|NCT03444298|141378205|SUPERIORITY|||||||0.04||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.04
70938853|NCT03444298|141378206|SUPERIORITY|||||||0.98||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.98
70938854|NCT03444298|141378206|SUPERIORITY|||||||0.02||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.02
70938855|NCT03444298|141378207|SUPERIORITY|||||||0.84||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.84
70938856|NCT03444298|141378208|SUPERIORITY|||||||0.59||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.59
70938857|NCT03444298|141378209|SUPERIORITY|||||||0.83||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.83
70938858|NCT03444298|141378210|SUPERIORITY|||||||0.51||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.51
70938859|NCT03444298|141378211|SUPERIORITY|||||||0.48||||||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||||0.48
70938860|NCT03444298|141378212|SUPERIORITY||||||<|0.01||||||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||||<0.01
70938861|NCT03444298|141378213|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||||<0.0001
70938862|NCT01857362|141378220|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established if the 90% confidence interval for the ratio is completely within the acceptance range (0.80-1.25)|Ratio of geomectric means|1.0|||||TWO_SIDED|90.0|0.988|1.045|||ANOVA|||||1.045|0.988|
70938863|NCT01857362|141378221|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established if the 90% confidence interval for the ratio is completely within the acceptance range (0.80-1.25)|ratio of geometric means|0.989|||||TWO_SIDED|90.0|0.945|1.034|||ANOVA|||||1.034|0.945|
70938864|NCT00409006|141378256|SUPERIORITY_OR_OTHER|||||||0.0618||95.0|||||Log Rank|||||||0.0618
70938865|NCT00409006|141378257|SUPERIORITY_OR_OTHER|||||||0.369||95.0|||||Regression, Logistic|Used the Wald Chi-squared statistic from a logistic regression analysis.||||||0.369
70938866|NCT00507429|141378264|SUPERIORITY_OR_OTHER|||||||0.223|||||||Log Rank|||||||0.223
70938867|NCT01574105|141378284|NON_INFERIORITY_OR_EQUIVALENCE|Sample sizes of 26 in heparin resistant group and 26 in heparin sensitive group achieve 90% power at the 0.025 level of significance to detect a non-inferiority using a one-sided two-sample t-test, assuming a noninferiority margin is 200 milliliters in the postoperative chest tube loss.|||||<|0.1||95.0|||||ANCOVA|||For the analysis of the patient characteristics Wilcoxon, Chi-square and Fischer's exact tests were used. An upper bound of a two-sided 95% confidence interval (CI) of the mean difference between resistant and sensitive groups for all values of chest tube losses was computed by analysis of covariance (ANCOVA), and compared with pre-specified noninferiority limits. Covariates in the ANCOVA model included patient characteristics differing between two groups with a p-value \<0.1.||||<0.1
70938868|NCT00608959|141378286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.91|STANDARD_DEVIATION|1.563|<|0.001||95.0|-2.55|-1.26|||t-test, 2 sided|||Based on a two-sided test at the 5% level of significance, and assuming a SD of 1.3, a sample size of 20 subjects would provide 90% power to detect a mean change of 0.942. No information was available concerning the within-subject variability between the arms.||-1.26|-2.55|<0.001
70941812|NCT01855997|141383953|SUPERIORITY_OR_OTHER|||||||7.66e-06|TWO_SIDED||||||t-test, 2 sided|||rs2812338||||0.00000766
70941813|NCT01855997|141383953|SUPERIORITY_OR_OTHER|||||||9.82e-06|TWO_SIDED||||||t-test, 2 sided|||rs10824875||||0.00000982
71067932|NCT04075682|141644505|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|3.45|STANDARD_ERROR_OF_MEAN|1.94||0.02|TWO_SIDED|95.0|1.15|10.37||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||10.37|1.15|0.02
71067933|NCT04075682|141644505|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|5.45|STANDARD_ERROR_OF_MEAN|4.4||0.04|TWO_SIDED|95.0|1.12|26.53||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||26.53|1.12|0.04
71067934|NCT04075682|141644505|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.59|STANDARD_ERROR_OF_MEAN|0.53||0.56|TWO_SIDED|95.0|0.1|3.47||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||3.47|0.10|0.56
71112456|NCT04551963|141731719|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.49|||||TWO_SIDED|90.0|0.41|0.58||||||Arm B: Zanubrutinib alone vs zanubrutinib + clarithromycin||0.58|0.41|
71067935|NCT04075682|141644505|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.55|STANDARD_ERROR_OF_MEAN|0.44||0.46|TWO_SIDED|95.0|0.11|2.68||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.68|0.11|0.46
71067936|NCT04075682|141644505|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.58|STANDARD_ERROR_OF_MEAN|0.66||0.0002|TWO_SIDED|95.0|1.56|4.27||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||4.27|1.56|0.0002
71067937|NCT04075682|141644505|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.89|STANDARD_ERROR_OF_MEAN|0.48||0.0135|TWO_SIDED|95.0|1.14|3.12||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||3.12|1.14|0.0135
71112457|NCT04551963|141731720|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.94|||||TWO_SIDED|90.0|0.82|1.08||||||Arm A: Zanubrutinib alone vs. zanubrutinib + fluconazole||1.08|0.82|
71112458|NCT04551963|141731720|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.81|||||TWO_SIDED|90.0|0.66|0.99||||||Arm A: Zanubrutinib alone vs. zanubrutinib + diltiazem||0.99|0.66|
70941814|NCT01855997|141383953|SUPERIORITY_OR_OTHER|||||||1.27e-06|TWO_SIDED||||||t-test, 2 sided|||rs1831559||||0.00000127
70938869|NCT00608959|141378286|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.87|STANDARD_DEVIATION|1.656|<|0.001||95.0|-2.57|-1.17|||t-test, 2 sided|||Based on a two-sided test at the 5% level of significance, and assuming a SD of 1.3, a sample size of 20 subjects would provide 90% power to detect a mean change of 0.942. No information was available concerning the within-subject variability between the arms.||-1.17|-2.57|<0.001
70938870|NCT04351243|141378289|SUPERIORITY||Risk Difference (RD)|0.05||||0.1885|TWO_SIDED|95.0|-0.06|0.17||one-sided p value|Mantel Haenszel|||||0.17|-0.06|0.1885
70938871|NCT01248715|141378299|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||.460
70938872|NCT01248715|141378300|SUPERIORITY|||||||0.9999|||||||Wilcoxon (Mann-Whitney)|||||||.9999
70938873|NCT01248715|141378301|SUPERIORITY|||||||0.732|||||||Wilcoxon (Mann-Whitney)|||||||.732
71067938|NCT04075682|141644505|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.51|STANDARD_ERROR_OF_MEAN|0.56||0.2619|TWO_SIDED|95.0|0.73|3.12||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||3.12|0.73|0.2619
70938874|NCT01248715|141378302|SUPERIORITY|||||||0.9999|||||||Wilcoxon (Mann-Whitney)|||||||.9999
70938875|NCT01248715|141378303|SUPERIORITY|||||||0.685|||||||Wilcoxon (Mann-Whitney)|||||||.685
70938876|NCT01248715|141378304|SUPERIORITY|||||||0.796|||||||Wilcoxon (Mann-Whitney)|||||||.796
70938877|NCT01248715|141378305|SUPERIORITY|||||||0.9999|||||||Wilcoxon (Mann-Whitney)|||||||.9999
71067939|NCT04075682|141644505|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.07|STANDARD_ERROR_OF_MEAN|0.76||0.0474|TWO_SIDED|95.0|1.01|4.24||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||4.24|1.01|0.0474
70938878|NCT01215253|141378341|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.117|TWO_SIDED|95.0|0.67|1.05|||Regression, Cox|||||1.05|0.67|0.117
70938879|NCT01215253|141378342|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.891|TWO_SIDED|95.0|0.76|1.26|||Regression, Cox|||||1.26|0.76|0.891
70938880|NCT01215253|141378343|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.028|TWO_SIDED|95.0|0.51|0.96|||Anderson-Gill analysis|||||0.96|0.51|0.028
70938881|NCT01215253|141378344|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.398|TWO_SIDED|95.0|0.38|1.47|||Regression, Cox|||||1.47|0.38|0.398
70938882|NCT01215253|141378345|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.316|TWO_SIDED|95.0|0.91|1.34|||Regression, Cox|||||1.34|0.91|0.316
70938883|NCT01215253|141378346|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.577|TWO_SIDED|95.0|0.84|1.37|||Regression, Cox|||||1.37|0.84|0.577
70938884|NCT01215253|141378347|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.871|TWO_SIDED|95.0|0.69|1.37|||Regression, Cox|||||1.37|0.69|0.871
70938885|NCT01215253|141378348|SUPERIORITY|||||||0.508|||||||nonparametric Wilcoxon rank-sum test|||||||0.508
70938886|NCT01215253|141378349|SUPERIORITY|||||||0.948|||||||nonparametric Wilcoxon rank-sum test|||||||0.948
70938887|NCT01215253|141378350|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.038|TWO_SIDED|95.0|0.55|0.98|||Regression, Cox|||||0.98|0.55|0.038
70938888|NCT01215253|141378351|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.947|TWO_SIDED|95.0|0.73|1.41|||Regression, Cox|||||1.41|0.73|0.947
70938889|NCT01215253|141378352|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.414|TWO_SIDED|95.0|0.36|1.52|||Anderdon-Gill analysis|||||1.52|0.36|0.414
70938890|NCT00674609|141378353|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|-0.67||||0.014|TWO_SIDED|95.0|-1.21|-0.14|||ANCOVA|||The change in mean pain NRS score (average pain) was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and region and treatment group as factors. The null hypothesis was that of no treatment difference.||-0.14|-1.21|0.014
70938891|NCT00674609|141378353|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.32||||0.244|TWO_SIDED|95.0|-0.86|0.22|||ANCOVA|||The change in mean pain NRS score (average pain) was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and region and treatment group as factors. The null hypothesis was that of no treatment difference.||0.22|-0.86|0.244
70938892|NCT00674609|141378354|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.31||||0.346|TWO_SIDED|95.0|-0.97|0.34|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||0.34|-0.97|0.346
70938893|NCT00674609|141378354|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.02||||0.95|TWO_SIDED|95.0|-0.64|0.68|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||0.68|-0.64|0.95
70938894|NCT00674609|141378355|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.49||||0.11|TWO_SIDED|95.0|-0.11|1.09|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.09|-0.11|0.11
70938895|NCT00674609|141378355|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.46||||0.126|TWO_SIDED|95.0|-0.13|1.05|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.05|-0.13|0.126
70938896|NCT00674609|141378356|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.65||||0.045|TWO_SIDED|95.0|0.01|1.28|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.28|0.01|0.045
70938897|NCT00674609|141378356|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.62||||0.053|TWO_SIDED|95.0|-0.01|1.25|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.25|-0.01|0.053
70938898|NCT00674609|141378357|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|0.83||||0.016|TWO_SIDED|95.0|0.16|1.51|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.51|0.16|0.016
70938899|NCT00674609|141378357|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.66||||0.056|TWO_SIDED|95.0|-0.02|1.33|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.33|-0.02|0.056
70938900|NCT00674609|141378358|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.68||||0.021|TWO_SIDED|95.0|0.1|1.25|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.25|0.10|0.021
70938901|NCT00674609|141378358|SUPERIORITY_OR_OTHER_LEGACY||Estimated treatment difference|0.64||||0.028|TWO_SIDED|95.0|0.07|1.22|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.22|0.07|0.028
71078894|NCT02756364|141665785|SUPERIORITY||Odds Ratio (OR)|1.75|||||TWO_SIDED|95.0|0.69|4.44|||||The odds ratio and 95% CIs were obtained using a stratified Cochran-Mantel-Haenszel model with the original IRT stratification factors (visceral metastases, previous sensitivity to hormonal therapy, and previous exposure to CDK4/6 inhibitors).|||4.44|0.69|
70941815|NCT01855997|141383953|SUPERIORITY_OR_OTHER|||||||3.96e-06|TWO_SIDED||||||t-test, 2 sided|||rs10851257||||0.00000396
70941816|NCT01855997|141383953|SUPERIORITY_OR_OTHER|||||||6.48e-06|TWO_SIDED||||||t-test, 2 sided|||rs6492344||||0.00000648
70941817|NCT01855997|141383953|SUPERIORITY_OR_OTHER|||||||2.21e-06|TWO_SIDED||||||t-test, 2 sided|||rs12584550||||0.00000221
71078895|NCT02655016|141665787|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.502|0.755||p-value was calculated based on stratified log-rank test using randomization stratification factors: administration of neoadjuvant chemotherapy, best response to platinum therapy and homologous recombination deficiency (HRD) status.|Log Rank||If hazard ratio was found to be \<1 then niraparib can be considered as superior to placebo.|||0.755|0.502|<0.0001
71078896|NCT02655016|141665788|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.1238|TWO_SIDED|95.0|0.442|1.106||p-value was calculated based on stratified log-rank test using randomization stratification factors: administration of neoadjuvant chemotherapy, best response to platinum therapy and HRD status.|Log Rank||If hazard ratio was found to be \<1 then niraparib can be considered as superior to placebo.|||1.106|0.442|0.1238
71067940|NCT04075682|141644505|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.13|STANDARD_ERROR_OF_MEAN|0.58||0.8094|TWO_SIDED|95.0|0.42|3.07||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||3.07|0.42|0.8094
71067941|NCT04075682|141644505|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.83|STANDARD_ERROR_OF_MEAN|0.6||0.7978|TWO_SIDED|95.0|0.2|3.44||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||3.44|0.20|0.7978
71067942|NCT04075682|141644505|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.29|STANDARD_ERROR_OF_MEAN|1.15||0.1016|TWO_SIDED|95.0|0.85|6.15||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||6.15|0.85|0.1016
71067943|NCT04075682|141644505|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.45|STANDARD_ERROR_OF_MEAN|0.25||0.157|TWO_SIDED|95.0|0.15|1.36||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.36|0.15|0.1570
71067944|NCT04075682|141644505|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|3.02|STANDARD_ERROR_OF_MEAN|1.53||0.0297|TWO_SIDED|95.0|1.11|8.18||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||8.18|1.11|0.0297
71067945|NCT04075682|141644505|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|5.28|STANDARD_ERROR_OF_MEAN|3.81||0.0213|TWO_SIDED|95.0|1.28|21.73||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||21.73|1.28|0.0213
71112459|NCT04551963|141731721|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.83|||||TWO_SIDED|90.0|0.65|1.06||||||Arm B: Zanubrutinib alone vs. zanubrutinib + voriconazole||1.06|0.65|
71112460|NCT04551963|141731721|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.48|||||TWO_SIDED|90.0|0.4|0.58||||||Arm B: Zanubrutinib alone vs zanubrutinib + clarithromycin||0.58|0.40|
70941818|NCT01855997|141383953|SUPERIORITY_OR_OTHER|||||||9.02e-06|TWO_SIDED||||||t-test, 2 sided|||rs9555773||||0.00000902
70941819|NCT01855997|141383953|SUPERIORITY_OR_OTHER|||||||7.7e-07|TWO_SIDED||||||t-test, 2 sided|||rs7983441||||0.00000077
70941820|NCT01855997|141383953|SUPERIORITY_OR_OTHER|||||||4.8e-07|TWO_SIDED||||||t-test, 2 sided|||rs12446868||||0.00000048
70852748|NCT01578850|141194340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.68|TWO_SIDED|95.0|-0.77|0.5|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Swollen Joint Count: Week 28||0.50|-0.77|0.680
70938902|NCT00674609|141378359|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|2.47||||0.443|TWO_SIDED|95.0|-3.87|8.81|||ANCOVA|||Analysis of the change from baseline was assessed using ANCOVA, adjusting for the effects of the baseline value. The significance of the treatment effect, after adjusting for the baseline value, was assessed using the F-test from the ANCOVA. If found significant at the 5% level, then the mean difference between treatments together with 95% CI were presented.||8.81|-3.87|0.443
70938903|NCT00674609|141378359|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|0.84||||0.793|TWO_SIDED|95.0|-5.46|7.13|||ANCOVA|||Analysis of the change from baseline was assessed using ANCOVA, adjusting for the effects of the baseline value. The significance of the treatment effect, after adjusting for the baseline value, was assessed using the F-test from the ANCOVA. If found significant at the 5% level, then the mean difference between treatments together with 95% CI were presented.||7.13|-5.46|0.793
71067946|NCT04075682|141644505|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.96|STANDARD_ERROR_OF_MEAN|0.78||0.9648|TWO_SIDED|95.0|0.2|4.74||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||4.74|0.20|0.9648
70852749|NCT01578850|141194340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.437|TWO_SIDED|95.0|-1.04|0.45|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Swollen Joint Count: Week 36||0.45|-1.04|0.437
70852750|NCT01578850|141194340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.131|TWO_SIDED|95.0|-1.31|0.17|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Swollen Joint Count: Week 44||0.17|-1.31|0.131
70852751|NCT01578850|141194340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.199|TWO_SIDED|95.0|-1.22|0.25|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Swollen Joint Count: Week 52||0.25|-1.22|0.199
70941821|NCT01855997|141383953|SUPERIORITY_OR_OTHER|||||||3.7e-07|TWO_SIDED||||||t-test, 2 sided|||rs247878||||0.00000037
71067947|NCT04075682|141644505|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.72|STANDARD_ERROR_OF_MEAN|0.53||0.6512|TWO_SIDED|95.0||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||||0.6512
71067948|NCT04075682|141644506|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.55|STANDARD_ERROR_OF_MEAN|0.66||0.41|TWO_SIDED|95.0|-0.75|1.85||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.85|-0.75|0.41
71067949|NCT04075682|141644506|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-1.67|STANDARD_ERROR_OF_MEAN|0.96||0.08|TWO_SIDED|95.0|-3.55|0.21||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.21|-3.55|0.08
71067950|NCT04075682|141644506|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|0.95||0.55|TWO_SIDED|95.0|-2.42|1.29||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.29|-2.42|0.55
71112461|NCT04551963|141731722|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.45|||||TWO_SIDED|90.0|0.35|0.58||||||Arm A: Zanubrutinib alone vs. zanubrutinib + fluconazole||0.58|0.35|
71112462|NCT04551963|141731722|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.41|||||TWO_SIDED|90.0|0.32|0.51||||||Arm A: Zanubrutinib alone vs. zanubrutinib + diltiazem||0.51|0.32|
71112463|NCT04551963|141731723|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.82|||||TWO_SIDED|90.0|0.68|1.0||||||Arm B: Zanubrutinib alone vs. zanubrutinib + voriconazole||1.00|0.68|
71112464|NCT04551963|141731723|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.5|||||TWO_SIDED|90.0|0.39|0.64||||||Arm B: Zanubrutinib alone vs. zanubrutinib + clarithromycin||0.64|0.39|
71112465|NCT00700622|141731748|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 92 subjects in each group was required to complete the trial. Approximately 230 subjects were to be randomized to achieve 184 completers (assuming a 20% dropout rate). This would have provided 80% power for a noninferiority design to test the difference of a 4-month change in HbA1c levels between treatment groups, assuming the upper noninferiority margins Δ of 0.5% with a standard deviation of 1.2 and a 1-sided alpha of 0.025.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.119|||TWO_SIDED|95.0|-0.31|0.17|||ANCOVA|||||0.17|-0.31|
71112466|NCT01204905|141731788|OTHER|This was a pilot study with a small sample population. There were no power calculations performed.|||||||||||||||||The percentage of patients with HIV-1 viral loads less than 50 c/ml at 48 weeks.|||
71112467|NCT01204905|141731789|OTHER|There were no power calculations performed due to the size of the pilot study.|||||||||||||||||Number of weeks to virologic suppression|||
71112468|NCT02526212|141731792|SUPERIORITY|||||||0.44|||||||Fisher Exact|||Due to the small sample size, planned analyses that assessed for clustering by group assignment or primary care physician could not be conducted. Chi square using fisher's exact test was conducted to investigate differences in abstinence between study arms.||||0.44
70941822|NCT01855997|141383954|SUPERIORITY_OR_OTHER|||||||9.87e-06|TWO_SIDED||||||t-test, 2 sided|||rs1876154||||0.00000987
71112469|NCT02526212|141731795|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||Each of the 17 items were rated on a scale from 1 to 5. For each participant, the scores from these items were summed and divided by 17 for an average satisfaction score. The average satisfaction score was compared between study arms.||||0.20
71112470|NCT03645096|141731797|SUPERIORITY||Mean Difference (Final Values)|0.0493|STANDARD_ERROR_OF_MEAN|0.0554||0.195|TWO_SIDED|95.0|-0.0703|0.1689||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (500 mg)|"Null Hypothesis: Amygdala-PCC functional connectivity (z-score) at 500 mg will be less than or equal to that at placebo.~Alternative Hypothesis: Amygdala-PCC functional connectivity (z-score) at 500 mg will be greater than that at placebo."||0.1689|-0.0703|.195
71112471|NCT03645096|141731797|SUPERIORITY||Mean Difference (Final Values)|0.0262|STANDARD_ERROR_OF_MEAN|0.0565||0.325|TWO_SIDED|95.0|-0.0943|0.1467||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (800 mg)|"Null Hypothesis: Amygdala-PCC functional connectivity (z-score) at 800 mg will be less than or equal to that at placebo.~Alternative Hypothesis: Amygdala-PCC functional connectivity (z-score) at 800 mg will be greater than that at placebo."||0.1467|-0.0943|.325
71112472|NCT03645096|141731798|SUPERIORITY||Mean Difference (Final Values)|-0.0071|STANDARD_ERROR_OF_MEAN|0.0878||0.468|TWO_SIDED|95.0|-0.1969|0.1827||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (500 mg)|"Null Hypothesis: dlPFC-Insula functional connectivity (z-score) at 500 mg will be less than or equal to that at placebo.~Alternative Hypothesis: dlPFC-Insula functional connectivity (z-score) at 500 mg will be greater than that at placebo."||0.1827|-0.1969|.468
71112473|NCT03645096|141731798|SUPERIORITY||Mean Difference (Final Values)|0.0097|STANDARD_ERROR_OF_MEAN|0.0891||0.458|TWO_SIDED|95.0|-0.1803|0.1996||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (800 mg)|"Null Hypothesis: dlPFC-Insula functional connectivity (z-score) at 800 mg will be less than or equal to that at placebo.~Alternative Hypothesis: dlPFC-Insula functional connectivity (z-score) at 800 mg will be greater than that at placebo."||0.1996|-0.1803|.458
71112474|NCT03645096|141731799|SUPERIORITY||Mean Difference (Final Values)|0.0038|STANDARD_ERROR_OF_MEAN|0.0078||0.316|TWO_SIDED|95.0|-0.0132|0.0209||Paired samples t-test with corrected standard deviation of the difference.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (500 mg)|"Null Hypothesis: GABA concentration (mM) at 500 mg will be less than or equal to that at placebo.~Alternative Hypothesis: GABA concentration (mM) at 500 mg will be greater than that at placebo."||0.0209|-0.0132|.316
71112475|NCT03645096|141731799|SUPERIORITY||Mean Difference (Final Values)|0.0131|STANDARD_ERROR_OF_MEAN|0.0084||0.071|TWO_SIDED|95.0|-0.005|0.0312||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (800 mg)|"Null Hypothesis: GABA concentration (mM) at 500 mg will be less than or equal to that at placebo.~Alternative Hypothesis: GABA concentration (mM) at 500 mg will be greater than that at placebo."||0.0312|-0.0050|.071
70941823|NCT01855997|141383954|SUPERIORITY_OR_OTHER|||||||6.05e-06|TWO_SIDED||||||t-test, 2 sided|||rs7753766||||0.00000605
70941824|NCT01855997|141383954|SUPERIORITY_OR_OTHER|||||||9.46e-06|TWO_SIDED||||||t-test, 2 sided|||rs604241||||0.00000946
70852752|NCT01578850|141194340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16||||0.115|TWO_SIDED|95.0|-2.6|0.28|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Tender Joint Count: Week 28||0.28|-2.60|0.115
71067951|NCT04075682|141644506|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.2|STANDARD_ERROR_OF_MEAN|1.36||0.38|TWO_SIDED|95.0|-1.47|3.86||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||3.86|-1.47|0.38
71067952|NCT04075682|141644506|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.54|STANDARD_ERROR_OF_MEAN|1.44||0.71|TWO_SIDED|95.0|-3.35|2.28||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||2.28|-3.35|0.71
71067953|NCT04075682|141644506|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|3.21|STANDARD_ERROR_OF_MEAN|1.34||0.02|TWO_SIDED|95.0|0.59|5.83||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||5.83|0.59|0.02
71067954|NCT04075682|141644506|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|1.94||0.98|TWO_SIDED|95.0|-3.85|3.76||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||3.76|-3.85|0.98
71067955|NCT04075682|141644506|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-2.13|STANDARD_ERROR_OF_MEAN|2.08||0.31|TWO_SIDED|95.0|-6.2|1.95||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.95|-6.2|0.31
71078602|NCT01441245|141665085|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.|||||<|0.01|TWO_SIDED||||||Chi-squared|||Qualitative variables are expressed as percentage and compared with chi-square test. p values \<0.05 were considered significant.||||<0.01
71112476|NCT03645096|141731800|SUPERIORITY||Mean Difference (Final Values)|-11322.45|STANDARD_ERROR_OF_MEAN|3750.52||0.006|TWO_SIDED|95.0|-19577.27|-3067.62||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (500 mg)|"Null Hypothesis: Pregnenolone level (pg/mL) at 500 mg will be less than or equal to that at placebo.~Alternative Hypothesis: Pregnenolone level (pg/mL) at 500 mg will be greater than that at placebo."||-3067.62|-19577.27|.006
70852753|NCT01578850|141194340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88||||0.017|TWO_SIDED|95.0|-3.42|-0.35|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Tender Joint Count: Week 36||-0.35|-3.42|0.017
70852754|NCT01578850|141194340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.34||||0.004|TWO_SIDED|95.0|-3.91|-0.76|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Tender Joint Count: Week 44||-0.76|-3.91|0.004
70941825|NCT01855997|141383954|SUPERIORITY_OR_OTHER|||||||7.7e-07|TWO_SIDED||||||t-test, 2 sided|||rs12446868||||0.00000077
70938904|NCT00674609|141378360|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.04||||0.619|TWO_SIDED|95.0|-5.23|3.15|||ANCOVA|||Change in pain scores on-treatment were be compared between groups using analysis of covariance (ANCOVA). The baseline pain score was fitted as a covariate in the model. The significance of the treatment effect after adjusting for baseline pain score was assessed using the F-test from the ANCOVA. If this was significant at the 5% level, then the mean difference between treatments together with the 95% confidence interval was presented for Sativex versus placebo and THC versus placebo.||3.15|-5.23|0.619
71112477|NCT03645096|141731800|SUPERIORITY||Mean Difference (Final Values)|-11828.78|STANDARD_ERROR_OF_MEAN|3620.42||0.003|TWO_SIDED|95.0|-19650.24|-4007.33||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (800 mg)|"Null Hypothesis: Pregnenolone level (pg/mL) at 800 mg will be less than or equal to that at placebo.~Alternative Hypothesis: Pregnenolone level (pg/mL) at 800 mg will be greater than that at placebo."||-4007.33|-19650.24|.003
71112478|NCT03645096|141731801|SUPERIORITY||Mean Difference (Final Values)|-2523.58|STANDARD_ERROR_OF_MEAN|545.83||0.001|TWO_SIDED|95.0|-3724.93|-1322.22||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (500 mg)|"Null Hypothesis: Allopregnanolone level (pg/mL) at 500 mg will be less than or equal to that at placebo.~Alternative Hypothesis: Allopregnanolone level (pg/mL) at 500 mg will be greater than that at placebo."||-1322.22|-3724.93|.001
71112479|NCT03645096|141731801|SUPERIORITY||Mean Difference (Final Values)|-2480.62|STANDARD_ERROR_OF_MEAN|582.63||0.001|TWO_SIDED|95.0|-3739.32|-1221.93||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (800 mg)|"Null Hypothesis: Allopregnanolone level (pg/mL) at 800 mg will be less than or equal to that at placebo.~Alternative Hypothesis: Allopregnanolone level (pg/mL) at 800 mg will be greater than that at placebo."||-1221.93|-3739.32|.001
70938905|NCT00674609|141378360|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-4.07||||0.048|TWO_SIDED|95.0|-8.1|-0.05|||ANCOVA|||Change in pain scores on-treatment were be compared between groups using analysis of covariance (ANCOVA). The baseline pain score was fitted as a covariate in the model. The significance of the treatment effect after adjusting for baseline pain score was assessed using the F-test from the ANCOVA. If this was significant at the 5% level, then the mean difference between treatments together with the 95% confidence interval was presented for Sativex versus placebo and THC versus placebo.||-0.05|-8.10|0.048
70938906|NCT00674609|141378361|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|-0.04||||0.688|TWO_SIDED|95.0|-0.25|0.16|||Regression, Logistic|||The on-treatment data was calculated from all available data during the last three days. The number of days the escape medication was used out of the last three days taken in the study was compared between treatments using logistic regression with a cumulative logit model. From this analysis the frequency distribution (%) of number days escape medication was used was presented together with the odds ratio, p-value and 95% CI for the treatment contrasts.||0.16|-0.25|0.688
71112480|NCT03645096|141731802|NON_INFERIORITY|"Using the two one-sided test (TOST) procedure (Schuirmann, 1987), equivalence is established at the α significance level if a (1-2α) × 100% confidence interval for the difference in efficacies (new - current) is contained within the interval (-δ, δ)~Schuirmann, D. J. (1987). A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. Journal of pharmacokinetics and biopharmaceutics, 15, 657-680."|Mean Difference (Final Values)|0.7059|STANDARD_ERROR_OF_MEAN|1.6377||0.336|TWO_SIDED|95.0|-2.7659|4.1777||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (500 mg)|"Null Hypothesis: SAFTEE (total) scores at 500 mg will be greater than or equal to that at placebo.~Alternative Hypothesis: SAFTEE (total) scores at 500 mg will be less than that at placebo."||4.1777|-2.7659|.336
71112481|NCT03645096|141731802|NON_INFERIORITY|"Using the two one-sided test (TOST) procedure (Schuirmann, 1987), equivalence is established at the α significance level if a (1-2α) × 100% confidence interval for the difference in efficacies (new - current) is contained within the interval (-δ, δ)~Schuirmann, D. J. (1987). A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. Journal of pharmacokinetics and biopharmaceutics, 15, 657-680."|Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|3.4662||0.24|TWO_SIDED|95.0|-9.8131|4.8131||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (800 mg)|"Null Hypothesis: SAFTEE (total) scores at 800 mg will be greater than or equal to that at placebo.~Alternative Hypothesis: SAFTEE (total) scores at 800 mg will be less than that at placebo."||4.8131|-9.8131|.240
71112482|NCT00040742|141731804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.566|STANDARD_ERROR_OF_MEAN|0.145||0.017|TWO_SIDED|||||The p-value was adjusted using theTukey-Kramer method.|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (0.5 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 0.5g and placebo of change from baseline of Peak Acute Nausea = 0.~Ha: Mean difference between 0.5g and placebo of change from baseline of Peak Acute Nausea \> 0. (Two-sided)"||||.017
71112483|NCT00040742|141731804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.506|STANDARD_ERROR_OF_MEAN|0.141||0.036|TWO_SIDED|||||The p-value was adjusted using theTukey-Kramer method.|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (1 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 1.0g and placebo of change from baseline of Peak Acute Nausea = 0.~Ha: Mean difference between 1.0g and placebo of change from baseline of Peak Acute Nausea \> 0. (Two-sided)"||||0.036
71112484|NCT00040742|141731804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.269|STANDARD_ERROR_OF_MEAN|0.137||0.431|TWO_SIDED|||||The p-value was adjusted using theTukey-Kramer method.|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (1.5 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 1.5g and placebo of change from baseline of Peak Acute Nausea = 0.~Ha: Mean difference between 1.5g and placebo of change from baseline of Peak Acute Nausea \> 0. (Two-sided)"||||0.431
70852755|NCT01578850|141194340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.58||||0.002|TWO_SIDED|95.0|-4.19|-0.97|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Tender Joint Count: Week 52||-0.97|-4.19|0.002
70941826|NCT01855997|141383954|SUPERIORITY_OR_OTHER|||||||1.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs247878||||0.00000197
70852756|NCT01578850|141194340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.368|TWO_SIDED|95.0|-1.13|0.42|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Swollen Joint Count: Week 28||0.42|-1.13|0.368
71112485|NCT00040742|141731804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.16||0.003|TWO_SIDED||||||Mixed Models Analysis|Parameter estimated using a contrast.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (any ginger - placebo). Negative values are favorable for the ginger group.|"Placebo vs. Any Ginger. H0: Mean difference between \[(0.5g +1.0g +1.5g) / 3\] and placebo of change from baseline of Peak Acute Nausea = 0.~Ha: Mean difference between \[(0.5g +1.0g +1.5g) / 3\] and placebo of change from baseline of Peak Acute Nausea \> 0. (Two-sided)"||||0.003
70852757|NCT01578850|141194340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.208|TWO_SIDED|95.0|-1.46|0.32|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Swollen Joint Count: Week 36||0.32|-1.46|0.208
70941827|NCT01855997|141383955|SUPERIORITY_OR_OTHER|||||||6.77e-06|TWO_SIDED||||||t-test, 2 sided|||rs12210761||||0.00000677
70941828|NCT01855997|141383955|SUPERIORITY_OR_OTHER|||||||7.98e-06|TWO_SIDED||||||t-test, 2 sided|||rs1831559||||0.00000798
70941829|NCT01855997|141383955|SUPERIORITY_OR_OTHER|||||||5.12e-06|TWO_SIDED||||||t-test, 2 sided|||rs7983441||||0.00000512
71112486|NCT00040742|141731805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.441|STANDARD_ERROR_OF_MEAN|0.127||0.046|TWO_SIDED|||||The p-value was adjusted using theTukey-Kramer method|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (0.5 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 0.5g and placebo of change from baseline of Average Acute Nausea = 0.~Ha: Mean difference between 0.5g and placebo of change from baseline of Average Acute Nausea \> 0. (Two-sided)"||||0.046
71112487|NCT00040742|141731805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.402|STANDARD_ERROR_OF_MEAN|0.124||0.076|TWO_SIDED|||||The p-value was adjusted using theTukey-Kramer method.|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (1 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 1.0g and placebo of change from baseline of Average Acute Nausea = 0.~Ha: Mean difference between 1.0g and placebo of change from baseline of Average Acute Nausea \> 0. (Two-sided)"||||0.076
71112488|NCT00040742|141731805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.158|STANDARD_ERROR_OF_MEAN|0.12||0.738|TWO_SIDED|||||The p-value was adjusted using theTukey-Kramer method.|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (1.5 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 1.5g and placebo of change from baseline of Average Acute Nausea = 0.~Ha: Mean difference between 1.5g and placebo of change from baseline of Average Acute Nausea \> 0. (Two-sided)"||||0.738
71112489|NCT00040742|141731805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.14||0.013|TWO_SIDED||||||Mixed Models Analysis|Contrasts used for estimation.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (any ginger - placebo). Negative values are favorable for the ginger group.|"Placebo vs Any Ginger. H0: Mean difference between \[(0.5g +1.0g +1.5g) / 3\] and placebo of change from baseline of Average Acute Nausea = 0.~Ha: Mean difference between \[(0.5g +1.0g +1.5g) / 3\] and placebo of change from baseline of Average Acute Nausea \> 0. (Two-sided)"||||0.013
71112490|NCT00405392|141731828|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71112491|NCT00405392|141731829|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71112492|NCT00405392|141731830|SUPERIORITY_OR_OTHER|||||||0.9456|||||||t-test, 2 sided|||||||0.9456
71112493|NCT04904744|141731839|SUPERIORITY||Odds Ratio (OR)|1.35||||0.165|TWO_SIDED|95.0|0.88|2.06|||Regression, Logistic||Low Tailored Message vs. No Message (reference group)|||2.06|0.88|0.165
70941830|NCT01855997|141383955|SUPERIORITY_OR_OTHER|||||||3.45e-06|TWO_SIDED||||||t-test, 2 sided|||rs12446868||||0.00000345
71112494|NCT04904744|141731839|SUPERIORITY||Odds Ratio (OR)|1.33||||0.193|TWO_SIDED|95.0|0.87|2.03|||Regression, Logistic||Low tailored message plus COVID-19 vaccine message vs. No Message|||2.03|0.87|0.193
71112495|NCT04904744|141731839|SUPERIORITY||Odds Ratio (OR)|1.02||||0.93|TWO_SIDED|95.0|0.68|1.52|||Regression, Logistic||Low Tailored Message vs. Low tailored message plus COVID-19 vaccine message|||1.52|0.68|0.930
71112496|NCT04904744|141731840|SUPERIORITY||Odds Ratio (OR)|2.07||||0.008|TWO_SIDED|95.0|1.21|3.52|||Regression, Logistic||Low Tailored Message vs. No Message|||3.52|1.21|0.008
71112497|NCT04904744|141731840|SUPERIORITY||Odds Ratio (OR)|1.25||||0.457|TWO_SIDED|95.0|0.7|2.23|||Regression, Logistic||Low tailored message plus COVID-19 vaccine message vs. No Message|||2.23|0.70|0.457
71112498|NCT04904744|141731840|SUPERIORITY||Odds Ratio (OR)|1.66||||0.049|TWO_SIDED|95.0|1.0|2.74|||Regression, Logistic||Low Tailored Message vs. Low tailored message plus COVID-19 vaccine message|||2.74|1.00|0.049
71112499|NCT04904744|141731841|SUPERIORITY||Odds Ratio (OR)|2.04||||0.104|TWO_SIDED|95.0|0.86|4.82|||Regression, Logistic||Low Tailored Message vs. No Message|||4.82|0.86|0.104
71112500|NCT04904744|141731841|SUPERIORITY||Odds Ratio (OR)|1.26||||0.631|TWO_SIDED|95.0|0.49|3.22|||Regression, Logistic||Low tailored message plus COVID-19 vaccine message vs. No Message|||3.22|0.49|0.631
71112501|NCT04904744|141731841|SUPERIORITY||Odds Ratio (OR)|1.62||||0.238|TWO_SIDED|95.0|0.73|3.61|||Regression, Logistic||Low Tailored Message vs. Low tailored message plus COVID-19 vaccine message|||3.61|0.73|0.238
71112502|NCT02550288|141731843|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-36.3|||<|0.001|TWO_SIDED|95.0|-40.5|-32.2|||Constrained longitudinal data analysis|||||-32.2|-40.5|<0.001
71112503|NCT02550288|141731843|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-11.6|||<|0.001|TWO_SIDED|95.0|-14.9|-8.2|||Constrained longitudinal data analysis|||||-8.2|-14.9|<0.001
71112504|NCT02550288|141731843|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-39.9|||<|0.001|TWO_SIDED|95.0|-44.1|-35.8|||Constrained longitudinal data analysis|||||-35.8|-44.1|<0.001
71112505|NCT02550288|141731843|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-10.1|||<|0.001|TWO_SIDED|95.0|-13.5|-6.8|||Constrained longitudinal data analysis|||||-6.8|-13.5|<0.001
71112506|NCT02819297|141731861|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70941831|NCT01855997|141383955|SUPERIORITY_OR_OTHER|||||||3.72e-06|TWO_SIDED||||||t-test, 2 sided|||rs247878||||0.00000372
70941832|NCT01855997|141383956|SUPERIORITY_OR_OTHER|||||||4.59e-06|TWO_SIDED||||||t-test, 2 sided|||rs12210761||||0.00000459
70941833|NCT01855997|141383956|SUPERIORITY_OR_OTHER|||||||9.25e-06|TWO_SIDED||||||t-test, 2 sided|||rs1411283||||0.00000925
71067956|NCT04075682|141644506|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|1.93||0.68|TWO_SIDED|95.0|-4.58|2.97||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.97|-4.58|0.68
71067957|NCT04075682|141644507|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.3||0.45|TWO_SIDED|95.0|-0.81|0.36||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.36|-0.81|0.45
71067958|NCT04075682|141644507|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.25||0.5767|TWO_SIDED|95.0|-0.64|0.7||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.70|-0.64|0.5767
71067959|NCT04075682|141644508|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|0.34||0.36|TWO_SIDED|95.0|-0.98|0.36||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.36|-0.98|0.36
71067960|NCT04075682|141644508|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.67||0.63|TWO_SIDED|95.0|-1.64|0.99||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||0.99|-1.64|0.63
71067961|NCT04075682|141644508|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.25|STANDARD_ERROR_OF_MEAN|0.95||0.79|TWO_SIDED|95.0|-1.62|2.12||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||2.12|-1.62|0.79
71112507|NCT03928418|141731881|SUPERIORITY||Mean Difference (Net)|3.5|||<|0.001|TWO_SIDED|95.0|2.1|4.9||p-value comparing live call booster to SOC arm: p \< 0.001 (calculated)|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline # of drinking days, visit, arm, interaction btwn visit and arm|SOC arm minus live call booster arm reported here.|||4.9|2.1|<0.001
71112508|NCT03928418|141731881|SUPERIORITY||Mean Difference (Net)|3.6|||<|0.001|TWO_SIDED|95.0|2.2|5.1||p-value comparing technology booster to SOC arm: p \< 0.001 (calculated)|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline # of drinking days, visit, arm, interaction btwn visit and arm|SOC arm minus technology booster arm reported here.|||5.1|2.2|<0.001
70941834|NCT01855997|141383956|SUPERIORITY_OR_OTHER|||||||7.72e-06|TWO_SIDED||||||t-test, 2 sided|||rs12446868||||0.00000772
70941835|NCT01855997|141383957|SUPERIORITY_OR_OTHER|||||||4.7e-06|TWO_SIDED||||||t-test, 2 sided|||rs11163805||||0.00000470
70941836|NCT01855997|141383957|SUPERIORITY_OR_OTHER|||||||6.74e-06|TWO_SIDED||||||t-test, 2 sided|||rs6443144||||0.00000674
70941837|NCT01855997|141383957|SUPERIORITY_OR_OTHER|||||||9.52e-06|TWO_SIDED||||||t-test, 2 sided|||rs11139349||||0.00000952
70852758|NCT01578850|141194340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84||||0.064|TWO_SIDED|95.0|-1.73|0.05|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Swollen Joint Count: Week 44||0.05|-1.73|0.064
70941838|NCT01855997|141383957|SUPERIORITY_OR_OTHER|||||||6.08e-06|TWO_SIDED||||||t-test, 2 sided|||rs1831559||||0.00000608
71067962|NCT04075682|141644508|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.31||0.4491|TWO_SIDED|95.0|-0.84|0.37||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|These results from the multiple imputation model are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.37|-0.84|0.4491
71067963|NCT04075682|141644508|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.59||0.8713|TWO_SIDED|95.0|-1.26|1.06||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||1.06|-1.26|0.8713
71078603|NCT01441245|141665086|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.01|TWO_SIDED||||||t-test, 2 sided|||||||0.01
71078897|NCT02655016|141665789|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0001|TWO_SIDED|95.0|0.521|0.802||p-value was calculated based on stratified log-rank test using randomization stratification factors: administration of neoadjuvant chemotherapy, best response to platinum therapy and HRD status.|Log Rank||If hazard ratio was found to be \<1 then niraparib can be considered as superior to placebo.|||0.802|0.521|0.0001
71078898|NCT02655016|141665790|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.2242|TWO_SIDED|95.0|0.577|1.139||p-value was calculated based on stratified log-rank test using randomization stratification factors: administration of neoadjuvant chemotherapy, best response to platinum therapy and HRD status.|Log Rank||If hazard ratio was found to be \<1 then niraparib can be considered as superior to placebo.|||1.139|0.577|0.2242
71078899|NCT02223364|141665802|SUPERIORITY|||||||0.144|||||||Wilcoxon (Mann-Whitney)|||||||0.144
71078900|NCT02223364|141665802|SUPERIORITY|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
71078901|NCT02223364|141665802|SUPERIORITY|||||||0.196|||||||Wilcoxon (Mann-Whitney)|||||||0.196
71078902|NCT02223364|141665803|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71078903|NCT02223364|141665803|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70941839|NCT01855997|141383957|SUPERIORITY_OR_OTHER|||||||4.04e-06|TWO_SIDED||||||t-test, 2 sided|||rs7983441||||0.00000404
70941840|NCT01855997|141383957|SUPERIORITY_OR_OTHER|||||||4.07e-06|TWO_SIDED||||||t-test, 2 sided|||rs11868362||||0.00000407
70941841|NCT01855997|141383958|SUPERIORITY_OR_OTHER|||||||6.66e-06|TWO_SIDED||||||t-test, 2 sided|||rs1384010||||0.00000666
71078904|NCT02223364|141665803|SUPERIORITY|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
71078905|NCT02223364|141665804|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71078906|NCT02223364|141665804|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71078907|NCT02223364|141665804|SUPERIORITY|||||||0.257|||||||Wilcoxon (Mann-Whitney)|||||||0.257
71078908|NCT02223364|141665805|SUPERIORITY|||||||0.059|||||||Wilcoxon (Mann-Whitney)|||||||0.059
71078909|NCT02223364|141665805|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
71078910|NCT02223364|141665805|SUPERIORITY|||||||0.214|||||||Wilcoxon (Mann-Whitney)|||||||0.214
71078911|NCT02223364|141665806|SUPERIORITY|||||||0.189|||||||Wilcoxon (Mann-Whitney)|||||||0.189
71078912|NCT02223364|141665806|SUPERIORITY|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||||||0.043
71078913|NCT02223364|141665806|SUPERIORITY|||||||0.357|||||||Wilcoxon (Mann-Whitney)|||||||0.357
71078914|NCT02223364|141665807|SUPERIORITY|||||||0.958|||||||Wilcoxon (Mann-Whitney)|||||||0.958
71078915|NCT02223364|141665807|SUPERIORITY|||||||0.203|||||||Wilcoxon (Mann-Whitney)|||||||0.203
71078916|NCT02223364|141665807|SUPERIORITY|||||||0.132|||||||Wilcoxon (Mann-Whitney)|||||||0.132
71078917|NCT02223364|141665808|SUPERIORITY|||||||0.493|||||||Wilcoxon (Mann-Whitney)|||||||0.493
71078918|NCT02223364|141665808|SUPERIORITY|||||||0.299|||||||Wilcoxon (Mann-Whitney)|||||||0.299
71078919|NCT02223364|141665808|SUPERIORITY|||||||0.797|||||||Wilcoxon (Mann-Whitney)|||||||0.797
71078920|NCT02223364|141665809|SUPERIORITY|||||||0.571|||||||Wilcoxon (Mann-Whitney)|||||||0.571
71078921|NCT02223364|141665809|SUPERIORITY|||||||0.991|||||||Wilcoxon (Mann-Whitney)|||||||0.991
71078922|NCT02223364|141665809|SUPERIORITY|||||||0.496|||||||Wilcoxon (Mann-Whitney)|||||||0.496
71078923|NCT02223364|141665810|SUPERIORITY|||||||0.807|||||||Wilcoxon (Mann-Whitney)|||||||0.807
71078924|NCT02223364|141665810|SUPERIORITY|||||||0.171|||||||Wilcoxon (Mann-Whitney)|||||||0.171
71078925|NCT02223364|141665810|SUPERIORITY|||||||0.104|||||||Wilcoxon (Mann-Whitney)|||||||0.104
71078926|NCT02223364|141665812|SUPERIORITY|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
71078927|NCT02223364|141665812|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71078928|NCT02223364|141665812|SUPERIORITY|||||||0.293|||||||Wilcoxon (Mann-Whitney)|||||||0.293
70938907|NCT00674609|141378361|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.01||||0.899|TWO_SIDED|95.0|-0.19|0.22|||Regression, Logistic|||The on-treatment data was calculated from all available data during the last three days. The number of days the escape medication was used out of the last three days taken in the study was compared between treatments using logistic regression with a cumulative logit model. From this analysis the frequency distribution (%) of number days escape medication was used was presented together with the odds ratio, p-value and 95% CI for the treatment contrasts.||0.22|-0.19|0.899
71067964|NCT04075682|141644508|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.85||0.99|TWO_SIDED|95.0|-1.66|1.66||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||1.66|-1.66|0.99
71067965|NCT04075682|141644509|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.69|STANDARD_ERROR_OF_MEAN|0.34||0.04|TWO_SIDED|95.0|0.02|1.37||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.37|0.02|0.04
71067966|NCT04075682|141644509|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.87|STANDARD_ERROR_OF_MEAN|0.5||0.08|TWO_SIDED|95.0|-1.85|0.11||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.11|-1.85|0.08
71067967|NCT04075682|141644509|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.23|STANDARD_ERROR_OF_MEAN|0.49||0.65|TWO_SIDED|95.0|-0.74|1.19||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.19|-0.74|0.65
71067968|NCT04075682|141644509|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.73|STANDARD_ERROR_OF_MEAN|0.71||0.3|TWO_SIDED|95.0|-0.66|2.11||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||2.11|-0.66|0.30
71067969|NCT04075682|141644509|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.75||0.78|TWO_SIDED|95.0|-1.68|1.26||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.26|-1.68|0.78
71067970|NCT04075682|141644509|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.48|STANDARD_ERROR_OF_MEAN|0.69||0.03|TWO_SIDED|95.0|0.12|2.83||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||2.83|0.12|0.03
71067971|NCT04075682|141644509|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|1.01||0.95|TWO_SIDED|95.0|-1.92|2.04||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.04|-1.92|0.95
71067972|NCT04075682|141644509|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.78|STANDARD_ERROR_OF_MEAN|1.09||0.48|TWO_SIDED|95.0|-2.91|1.36||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.36|-2.91|0.48
71067973|NCT04075682|141644509|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|1.0||0.37|TWO_SIDED|95.0|-2.86|1.07||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.07|-2.86|0.37
71067974|NCT04075682|141644509|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.73|STANDARD_ERROR_OF_MEAN|0.31||0.0192|TWO_SIDED|95.0|0.12|1.34||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.34|0.12|0.0192
71067975|NCT04075682|141644509|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.59|STANDARD_ERROR_OF_MEAN|0.45||0.186|TWO_SIDED|95.0|-1.48|0.29||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.29|-1.48|0.1860
71067976|NCT04075682|141644509|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.39|STANDARD_ERROR_OF_MEAN|0.44||0.3863|TWO_SIDED|95.0|-0.49|1.26||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.26|-0.49|0.3863
71078604|NCT01441245|141665087|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.02|TWO_SIDED||||||t-test, 2 sided|||||||0.02
71078929|NCT02223364|141665813|SUPERIORITY|||||||0.202|||||||Wilcoxon (Mann-Whitney)|||||||0.202
71078930|NCT02223364|141665813|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
71078931|NCT02223364|141665813|SUPERIORITY|||||||0.148|||||||Wilcoxon (Mann-Whitney)|||||||0.148
71112509|NCT03928418|141731882|SUPERIORITY||Mean Difference (Net)|36.4||||0.643|TWO_SIDED|95.0|-117.5|190.3||p-value comparing live call booster arm to SOC arm: p = 0.643|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline PEth level, visit, arm, interaction btwn visit and arm|SOC arm minus live call booster arm reported here.|||190.3|-117.5|0.643
71112510|NCT03928418|141731882|SUPERIORITY||Mean Difference (Net)|-30.9||||0.711|TWO_SIDED|95.0|-194.8|132.9||p-value comparing technology booster arm to SOC arm: p = 0.711|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline PEth level, visit, arm, interaction btwn visit and arm|SOC arm minus technology booster arm reported here.|||132.9|-194.8|0.711
71112511|NCT03928418|141731883|SUPERIORITY||Mean Difference (Net)|-2.3||||0.515|TWO_SIDED|95.0|-9.3|4.7||p-value comparing live call booster arm to SOC: p = 0.515|Regression, Logistic||SOC minus live call booster arm presented here.|||4.7|-9.3|0.515
71112512|NCT03928418|141731883|SUPERIORITY||Mean Difference (Net)|-0.9||||0.801|TWO_SIDED|95.0|-8.3|6.4||p-value comparing technology booster arm to SOC: p = 0.801|Regression, Logistic||SOC minus technology booster arm presented here.|||6.4|-8.3|0.801
71112513|NCT03928418|141731884|SUPERIORITY||Mean Difference (Net)|28.9|||<|0.001|TWO_SIDED|95.0|17.0|40.7||p-value comparing live call booster arm to SOC: p \< 0.001 (calculated)|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline alcohol use, visit, arm, interaction btwn visit and arm|SOC minus live call booster arm presented here.|||40.7|17.0|<0.001
71112514|NCT03928418|141731884|SUPERIORITY||Mean Difference (Net)|24.9|||<|0.001|TWO_SIDED|95.0|13.0|36.8||p-value comparing technology booster arm to SOC: p \< 0.001 (calculated)|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline alcohol use, visit, arm, interaction btwn visit and arm|SOC minus technology booster arm presented here.|||36.8|13.0|<0.001
71112515|NCT03928418|141731885|SUPERIORITY||Mean Difference (Net)|4.4||||0.002|TWO_SIDED|95.0|1.6|7.3||p-value comparing live call booster arm to SOC: p = 0.002|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline alcohol use, visit, arm, interaction btwn visit and arm|SOC arm minus live call booster arm presented here.|||7.3|1.6|0.002
71112516|NCT03928418|141731885|SUPERIORITY||Mean Difference (Net)|4.3||||0.003|TWO_SIDED|95.0|1.5|7.2||p-value comparing technology booster arm to SOC: p = 0.003|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline alcohol use, visit, arm, interaction btwn visit and arm|SOC arm minus technology booster arm presented here.|||7.2|1.5|0.003
71112517|NCT03928418|141731887|SUPERIORITY||Mean Difference (Net)|-0.8||||0.61|TWO_SIDED|95.0|-3.8|2.2||p-value comparing live call booster arm to SOC arm: p = 0.610.|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline ART adherence, visit, arm, interaction btwn visit and arm|SOC minus live call booster arm presented here.|||2.2|-3.8|0.610
71112518|NCT03928418|141731887|SUPERIORITY||Mean Difference (Net)|-1.1||||0.474|TWO_SIDED|95.0|-4.1|1.9||p-value comparing technology booster arm to SOC arm: p = 0.474.|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline ART adherence, visit, arm, interaction btwn visit and arm|SOC minus technology booster arm presented here.|||1.9|-4.1|0.474
71112519|NCT00763256|141731894|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||The null hypothesis states that there is no difference between groups.||||0.05
71112520|NCT00763256|141731895|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||The null hypothesis states that there is no difference between groups.||||0.05
71112521|NCT00763256|141731896|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||The null hypothesis states that there is no difference between groups.||||0.05
70941842|NCT01855997|141383958|SUPERIORITY_OR_OTHER|||||||8.44e-06|TWO_SIDED||||||t-test, 2 sided|||rs1351518||||0.00000844
71112522|NCT00763256|141731897|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||The null hypothesis states that there is no difference between groups.||||0.05
71112523|NCT00763256|141731898|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||The null hypothesis states that there is no difference between groups.||||0.05
71112524|NCT00244725|141731905|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.45||||0.012|TWO_SIDED|95.0|1.1|1.9|||Fisher Exact|||||1.9|1.1|0.012
71112525|NCT00244725|141731905|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.42||||0.017|TWO_SIDED|95.0|1.1|1.9|||Fisher Exact|||||1.9|1.1|0.017
71112526|NCT00244725|141731905|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.32||||0.08|TWO_SIDED|95.0|1.0|1.8|||Fisher Exact|||||1.8|1.0|0.080
71112527|NCT00418093|141731924|SUPERIORITY_OR_OTHER||Proportion|0.684|||||TWO_SIDED|95.0|0.43|0.87||Exact 95% CI for the partial response rate (13/19 = 0.684): 43.4% \~ 87.4%|Estimation of PR based on Binomial Model|We did not perform a test. Point estimate of PR and its exact 95% CI based on Binomial Model is provided. Thus there is no p-value to report.|Point estimate of PR and its exact 95% CI based on Binomial Model|||0.87|0.43|
71112528|NCT00418093|141731924|SUPERIORITY_OR_OTHER||Single Proportion|0.684|||||TWO_SIDED|95.0|0.434|0.874||We did not perform hypothesis test. We made an estimation for a single proportion (partial response) with its two-sided 95% exact Binomial confidence interval.|Fisher Exact||Estimation of a single proportion (partial response rate) with exact 95% Binomial confidence interval|||0.874|0.434|
71112529|NCT03711370|141731933|OTHER|Repeated measures ANOVA was used to model between-subject effects of group (Clear versus Opaque), within-subjects effects of use of clear versus opaque bottles during the feeding observations, and potential group by bottle type interactions on infant intake during post-test feeding observations.||||||0.76||||||Statistical significance was defined as p \< 0.05.|Mixed Models Analysis|Models controlled for pre-test values, infant sex and age, time since last feeding, and whether the assessment was in-person or remote.||||||0.76
71117744|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-36.26|||<|0.001|TWO_SIDED|95.0|-53.8|-18.73||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-18.73|-53.80|<0.001
70938908|NCT03785756|141378362|EQUIVALENCE|The primary analysis was based on a two-sided test at the significance level of 0.05. The treatment difference is presented with a 95% confidence interval (CI).|Mean Difference (Final Values)|34.05|||<|0.0001|TWO_SIDED|95.0|26.72|41.38|||ANCOVA|Estimates from an ANCOVA model with SPID12 score as the dependent variable. Terms for treatment and baseline pain score were included as covariates.||The primary efficacy hypothesis was that SPID12 for placebo was equal to SPID12 for ibuprofen 2 × 300 mg PR tablets.||41.38|26.72|<0.0001
71067977|NCT04075682|141644509|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.36|STANDARD_ERROR_OF_MEAN|0.64||0.571|TWO_SIDED|95.0|-0.89|1.61||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||1.61|-0.89|0.5710
71067978|NCT04075682|141644509|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.73|STANDARD_ERROR_OF_MEAN|0.68||0.2797|TWO_SIDED|95.0|-2.06|0.6||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||0.60|-2.06|0.2797
71067979|NCT04075682|141644509|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.33|STANDARD_ERROR_OF_MEAN|0.62||0.0312|TWO_SIDED|95.0|0.12|2.55||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||2.55|0.12|0.0312
71067980|NCT04075682|141644509|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.91||0.5086|TWO_SIDED|95.0|-1.19|2.39||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.39|-1.19|0.5086
71067981|NCT04075682|141644509|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.98||0.9474|TWO_SIDED|95.0|-1.86|1.99||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.99|-1.86|0.9474
71078605|NCT01441245|141665088|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||0.04
71078932|NCT02223364|141665814|SUPERIORITY|||||||0.933|||||||Wilcoxon (Mann-Whitney)|||||||0.933
71078933|NCT02223364|141665814|SUPERIORITY|||||||0.169|||||||Wilcoxon (Mann-Whitney)|||||||0.169
70938909|NCT03884478|141378399|OTHER||Mean Difference (Final Values)|3.25|STANDARD_ERROR_OF_MEAN|0.82||0.0001|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*T2 interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 2 month follow-up in the Alcohol+Coping Arm versus the Control Arm.||||.0001
71078934|NCT02223364|141665814|SUPERIORITY|||||||0.126|||||||Wilcoxon (Mann-Whitney)|||||||0.126
70852759|NCT01578850|141194340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.081|TWO_SIDED|95.0|-1.66|0.1|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Swollen Joint Count: Week 52||0.10|-1.66|0.081
70938910|NCT03884478|141378399|OTHER||Mean Difference (Final Values)|2.31|STANDARD_ERROR_OF_MEAN|0.77||0.005|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Control Arm\*T2 interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 2 month follow-up in the Alcohol+Control Arm versus the Control Arm.||||.005
71067982|NCT04075682|141644509|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.9||0.5018|TWO_SIDED|95.0|-2.36|1.16||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.16|-2.36|0.5018
70941843|NCT01855997|141383958|SUPERIORITY_OR_OTHER|||||||7.94e-06|TWO_SIDED||||||t-test, 2 sided|||rs1157322||||0.00000794
71078935|NCT02223364|141665815|SUPERIORITY|||||||0.768|||||||Kruskal-Wallis|||||||0.768
71078936|NCT02223364|141665816|SUPERIORITY|||||||0.623|||||||Regression, Cox|||Within group comparison of baseline and 3 months (approximately 12 weeks)||||0.623
71078937|NCT02223364|141665816|SUPERIORITY|||||||0.001|||||||Regression, Cox|||Within group comparison of baseline and 3 months (approximately 12 weeks)||||0.001
70941844|NCT01855997|141383958|SUPERIORITY_OR_OTHER|||||||3.1e-06|TWO_SIDED||||||t-test, 2 sided|||rs11868362||||0.00000310
71078938|NCT02223364|141665816|SUPERIORITY|||||||0.048|||||||Regression, Cox|||Within group comparison of baseline and three months (approximately 12 weeks)||||0.048
71078939|NCT02685072|141665889|SUPERIORITY||Odds Ratio (OR)|0.5818||||0.3253|TWO_SIDED|95.0|0.1968|1.7202|||Chi-squared|degrees of freedom =1|Odds ratio represents odds of smoking abstinence in TPN + progesterone group versus TPN + placebo group|||1.7202|0.1968|0.3253
71078940|NCT02685072|141665890|SUPERIORITY||Odds Ratio (OR)|1.0781||||0.8944|TWO_SIDED|95.0|0.355|3.2744|||Chi-squared|degrees of freedom = 1|Odds ratio represents odds of CO \< 10 (negative for smoking) in TPN + progesterone versus TPN + placebo groups|||3.2744|0.3550|0.8944
71078941|NCT02685072|141665891|SUPERIORITY||Odds Ratio (OR)|0.7619||||0.662|TWO_SIDED|95.0|0.2247|2.5838|||Chi-squared|degrees of freedom = 1|Odds ratio represents odds of CO \< 10 ppm (negative for smoking) in TPN + progesterone versus TPN + placebo.|||2.5838|0.2247|0.6620
71078942|NCT02685072|141665892|SUPERIORITY||Odds Ratio (OR)|0.913||||0.8661|TWO_SIDED|95.0|0.3171|2.6287|||Chi-squared|degrees of freedom = 1|Odds ratio represents odds of CO \< 10 ppm (negative for smoking) in TPN + progesterone versus TPN + placebo.|||2.6287|0.3171|0.8661
71078943|NCT02685072|141665893|SUPERIORITY||Mean Difference (Final Values)|-9.1|STANDARD_DEVIATION|31.7||0.31|TWO_SIDED|95.0|-27.1|9.0|||t-test, 2 sided||(Placebo + TPN) - (Progesterone + TPN)|||9.0|-27.1|0.31
71078944|NCT02685072|141665894|SUPERIORITY||Mean Difference (Final Values)|0.148||||0.791|TWO_SIDED|95.0|-0.9747|1.2707|||t-test, 2 sided||(placebo + TPN) - (progesterone + TPN)|||1.2707|-0.9747|0.7910
71078945|NCT02685072|141665895|SUPERIORITY||Mean Difference (Final Values)|9.26||||0.0065|TWO_SIDED|95.0|2.71|15.81|||t-test, 2 sided|||||15.81|2.71|0.0065
71078946|NCT02685072|141665906|SUPERIORITY||Odds Ratio (OR)|0.7172||||0.6449|TWO_SIDED|95.0|0.1738|2.9594|||Chi-squared|degrees of freedom = 1|Odds ratio represents odds of CO \< 10 ppm (negative for smoking) in TPN + progesterone versus TPN + placebo.|||2.9594|0.1738|.6449
71078947|NCT02685072|141665907|SUPERIORITY||Odds Ratio (OR)|0.7172||||0.6449|TWO_SIDED|95.0|0.1738|2.9594|||Chi-squared|degrees of freedom = 1|Odds ratio represents odds of prolonged abstinence in TPN + progesterone versus TPN + placebo.|||2.9594|0.1738|0.6449
71078948|NCT02717442|141665930|SUPERIORITY||Risk Ratio (RR)|0.658|||=|0.029|TWO_SIDED|95.0|0.453|0.957||Study week was based on each 4-week interval and was modeled as a categorical variable, and an offset for the log of the number of diary entries recorded for each 4-week interval post-baseline was included for each subject.|Regression, Linear|||The primary efficacy endpoint was compared between OTO-104 and placebo at the 2-tailed 0.05 alpha level using a generalized Poisson linear mixed model. The model included fixed effects for randomized treatment group, sex, study week, a treatment group by study week interaction, and the count of lead-in period DVD standardized to 28 days as a covariate.||0.957|0.453|=0.029
71078949|NCT02717442|141665931|SUPERIORITY||Risk Ratio (RR)|0.59|||=|0.014|TWO_SIDED|95.0|0.388|0.896|||Regression, Linear|||The primary efficacy endpoint was compared between OTO-104 and placebo at the 2-tailed 0.05 alpha level using a generalized Poisson linear mixed model. The model included fixed effects for randomized treatment group, sex, study week, a treatment group by study week interaction, and the count of lead-in period DVD standardized to 28 days as a covariate.||0.896|0.388|=0.014
71078950|NCT02798354|141665938|SUPERIORITY||Risk Difference (RD)|3.9|||<|0.0001|TWO_SIDED|95.0|2.4|5.3|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave|||5.3|2.4|<0.0001
71078951|NCT02798354|141665939|SUPERIORITY||Risk Difference (RD)|16.0|||<|0.0001|TWO_SIDED|95.0|12.3|20.0|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave|||20|12.3|<0.0001
71078952|NCT02798354|141665940|SUPERIORITY||Risk Difference (RD)|1.1||||0.302|TWO_SIDED|95.0|-1.0|3.1|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, lab test sent, and wave|||3.1|-1.0|0.302
71112530|NCT03711370|141731934|OTHER|Repeated measures ANOVA was used to model between-subject effects of group (Clear versus Opaque), within-subjects effects of use of clear versus opaque bottles during the feeding observations, and potential group by-bottle type interactions on maternal sensitivity during post-test feeding observations.||||||0.64||||||Statistical significance was defined as p \< 0.05.|Mixed Models Analysis|Models controlled for pre-test values, infant sex and age, time since last feeding, and whether the assessment was in-person or remote.||||||0.64
71112531|NCT03711370|141731935|OTHER|General linear models were used to compare post-test weight-for-length z-scores (WLZ).||||||0.02||||||Statistical significance was defined as p \< 0.05.|Regression, Linear|These models controlled for baseline values (i.e., baseline WLZ), infant sex and age, and whether the assessment was in-person or remote.||||||0.02
71112532|NCT03711370|141731936|OTHER|General linear models were used to compare post-test waist circumference for the Clear versus Opaque groups.||||||0.07||||||Statistical significance was defined as p \< 0.05.|Regression, Linear|Model controlled for baseline values (i.e., waist circumference), infant sex and age, and whether the assessment was in-person or remote.||||||0.07
71112533|NCT03711370|141731937|OTHER|General linear models were used to compare post-test triceps skinfold z-scores for the Clear versus Opaque groups.||||||0.7||||||Statistical significance was defined as p \< 0.05.|Regression, Linear|Model controlled for baseline values (i.e.,triceps skinfolds z-scores), infant sex and age, and whether the assessment was in-person or remote.||||||0.70
71112534|NCT01625416|141731984|SUPERIORITY|||||||0.05|||||||Chi-squared|Chi square (2) =5.9, p=0.05|||This chi-square analysis was derived from a mixed repeated measures model comparing intervention results with control results over 4 time points.|||0.05
71112535|NCT01625416|141731985|SUPERIORITY|||||||0.69|||||||Chi-squared|Chi square(2) = 0.74, p = 0.69|||This chi-square analysis was derived from a mixed repeated measures model comparing intervention results with control results over 4 time points.|||0.69
71112536|NCT01625416|141731988|SUPERIORITY|||||||0.97||||||Chi square (2) = 0.06, p = 0.97|Chi-squared||||This chi-square analysis was derived from a mixed repeated measures model comparing intervention results with control results over 4 time points.|||0.97
71067983|NCT04075682|141644510|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.45|STANDARD_ERROR_OF_MEAN|0.39||0.25|TWO_SIDED|95.0|-0.31|1.21||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.21|-0.31|0.25
70938911|NCT03884478|141378399|OTHER||Mean Difference (Final Values)|0.94|STANDARD_ERROR_OF_MEAN|0.82||0.25|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 2 month follow-up in the Alcohol+Coping Arm versus the Alcohol Only Arm.||||.25
70941845|NCT01855997|141383959|SUPERIORITY_OR_OTHER|||||||2.07e-06|TWO_SIDED||||||t-test, 2 sided|||rs11139349||||0.00000207
71078606|NCT01441245|141665088|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.|Risk Ratio (RR)|2.06||||0.01|TWO_SIDED|95.0|1.65|2.57|||Regression, Linear||BNP levels at discharge \>500 pg/ml (RR: 2.06 \[1.65-2.57\];).|||2.57|1.65|0.01
71112537|NCT01625416|141731989|SUPERIORITY|||||||0.71|||||||Chi-squared|Chi-Square (2) =0.68, p=0.71|||This chi-square analysis was derived from a mixed repeated measures model comparing intervention results with control results over 4 time points.|||0.71
71112538|NCT02311881|141732014|SUPERIORITY_OR_OTHER||LS mean difference|-2.51||||0.1626|TWO_SIDED|95.0|-6.037|1.016|||ANCOVA||LS treatment means from mixed model analysis of covariance with treatment, target joint and center pools as fixed effects and baseline as a covariate.|"H0: There is no significant difference in mean change from baseline through week 12 of WOMAC Pain between twice daily Paracetamol 1000 mg SR tablets and placebo.~H1: There is a significant difference in mean change from baseline through week 12 of WOMAC Pain between twice daily Paracetamol 1000 mg SR tablets and placebo."||1.016|-6.037|0.1626
71112539|NCT02311881|141732014|NON_INFERIORITY_OR_EQUIVALENCE|Paracetamol 2000mg BID is non-inferior to Paracetamol 1330mg TID if the upper bound of the 95% confidence Interval is less than 5.3.|LS mean difference|-2.36|||||TWO_SIDED|95.0|-5.894|1.166|||ANCOVA||LS treatment means from mixed model analysis of covariance with treatment, target joint and center pools as fixed effects and baseline as a covariate.|"H0: Difference in mean change from baseline through week 12 of WOMAC Pain between Paracetamol 1000 mg SR tablet and Paracetamol 665 mg SR tablet is ≤ - 5.3 (inferiority).~H1: Difference in mean change from baseline through week 12 of WOMAC Pain between Paracetamol 1000 mg SR tablet and Paracetamol 665 mg SR tablet is \> - 5.3 (noninferiority)."||1.166|-5.894|
71112540|NCT02311881|141732014|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.9352|TWO_SIDED|95.0|-3.687|3.394|||ANCOVA||LS treatment means from mixed model analysis of covariance with treatment, target joint and center pools as fixed effects and baseline as a covariate.|"H0: There is no significant difference in mean change from baseline through week 12 of WOMAC Pain between Paracetamol 665 mg SR tablets and placebo.~H1: There is a significant difference in mean change from baseline through week 12 of WOMAC Pain between Paracetamol 665 mg SR tablets and placebo."||3.394|-3.687|0.9352
71112541|NCT00819156|141732024|SUPERIORITY_OR_OTHER_LEGACY||Percentage|61.0||||||95.0|41.0|78.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||78|41|
70941846|NCT01855997|141383959|SUPERIORITY_OR_OTHER|||||||8.99e-06|TWO_SIDED||||||t-test, 2 sided|||rs1157322||||0.00000899
70938912|NCT03884478|141378400|OTHER||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.84||0.025|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Control Arm.||||.025
70938913|NCT03884478|141378400|OTHER||Mean Difference (Final Values)|1.24|STANDARD_ERROR_OF_MEAN|0.79||0.11|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*T2 interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 4 month follow-up in the Alcohol+Control Arm versus the Control Arm.||||.11
70938914|NCT03884478|141378400|OTHER||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.84||0.66|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Alcohol+Control Arm.||||.66
70938915|NCT03884478|141378401|OTHER||Mean Difference (Final Values)|1.51|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in peak drinks from baseline to the 2 month follow-up in the Alcohol+Coping Arm versus the Control Arm.||||<.001
70938916|NCT03884478|141378401|OTHER||Mean Difference (Final Values)|1.48|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on peak drinks. To probe the significant Alcohol+Control Arm\*Time interaction, a Tukey post-hoc test examined the change in peak drinks at the 2 month follow-up in the Alcohol+Control Arm versus the Control Arm.||||<.001
70938917|NCT03884478|141378401|OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.25||0.88|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on peak drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in peak drinks at the 2 month follow-up in the Alcohol+Coping Arm versus the Alcohol+Control Arm.||||.88
70938918|NCT03884478|141378402|OTHER||Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|0.26||0.03|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Control Arm.||||.03
70938919|NCT03884478|141378402|OTHER||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.24||0.059|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on peak drinks. To probe the significant Alcohol+Control Arm\*Time interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 4 month follow-up in the Alcohol+Control Arm versus the Control Arm.||||.059
71078953|NCT02798354|141665941|SUPERIORITY||Risk Difference (RD)|26.6|||<|0.0001|TWO_SIDED|95.0|22.4|30.7|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave|||30.7|22.4|<0.0001
70938920|NCT03884478|141378402|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.26||0.71|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in peak drinks from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Alcohol+Control Arm.||||.71
70938921|NCT03884478|141378403|OTHER||Mean Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 2 month follow-up in the Alcohol+Coping Arm versus the Control Arm.||||<.001
70938922|NCT03884478|141378403|OTHER||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Control Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 2 month follow-up in the Alcohol+Control Arm versus the Control Arm.||||<.001
70941847|NCT01855997|141383960|SUPERIORITY_OR_OTHER|||||||5.73e-06|TWO_SIDED||||||t-test, 2 sided|||rs1384010||||0.00000573
70941848|NCT01855997|141383960|SUPERIORITY_OR_OTHER|||||||9.46e-06|TWO_SIDED||||||t-test, 2 sided|||rs1351518||||0.00000946
71112542|NCT00819156|141732024|SUPERIORITY_OR_OTHER_LEGACY||Percentage|84.0||||||95.0|64.0|95.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||95|64|
70938923|NCT03884478|141378403|OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.19||0.87|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 2 month follow-up in the Alcohol+Coping Arm versus the Alcohol+Control Arm.||||.87
71067984|NCT04075682|141644510|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.53|STANDARD_ERROR_OF_MEAN|0.56||0.34|TWO_SIDED|95.0|-1.63|0.57||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.57|-1.63|0.34
71078607|NCT01441245|141665089|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.03|TWO_SIDED||||||t-test, 2 sided|||Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values \<0.05 were considered significant.||||0.03
71112543|NCT00819156|141732024|SUPERIORITY_OR_OTHER_LEGACY||Percentage|96.0||||||95.0|81.0|100.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||100|81|
71112544|NCT00819156|141732024|SUPERIORITY_OR_OTHER_LEGACY||Percentage|90.0||||||95.0|73.0|98.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||98|73|
71112545|NCT00819156|141732024|SUPERIORITY_OR_OTHER_LEGACY||Percentage|90.0||||||95.0|73.0|98.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||98|73|
71112546|NCT00819156|141732024|SUPERIORITY_OR_OTHER_LEGACY||Percentage|92.0||||||95.0|74.0|99.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||99|74|
70938924|NCT03884478|141378404|OTHER||Median Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Control Arm.||||<.001
70941849|NCT01855997|141383960|SUPERIORITY_OR_OTHER|||||||7.31e-06|TWO_SIDED||||||t-test, 2 sided|||rs1157322||||0.00000731
70941850|NCT01855997|141383960|SUPERIORITY_OR_OTHER|||||||9.45e-06|TWO_SIDED||||||t-test, 2 sided|||rs646097||||0.00000945
71112547|NCT00819156|141732025|SUPERIORITY_OR_OTHER_LEGACY||Percentage|92.0||||||95.0|80.0|98.0|||||The estimated value is the percentage of patients with Testosterone (T) \<=0.5 nanograms (ng)/milliliter (mL) from Day 28 to Day 364 for Patients With T \<=0.5 ng/mL at Day 28. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||98|80|
71112548|NCT00819156|141732025|SUPERIORITY_OR_OTHER_LEGACY||Percentage|96.0||||||95.0|86.0|100.0|||||The estimated value is the percentage of patients with Testosterone (T) \<=0.5 nanograms (ng)/milliliter (mL) from Day 28 to Day 364 for Patients With T \<=0.5 ng/mL at Day 28. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||100|86|
71112549|NCT00819156|141732025|SUPERIORITY_OR_OTHER_LEGACY||Percentage|100.0||||||95.0|93.0|100.0|||||The estimated value is the percentage of patients with Testosterone (T) \<=0.5 nanograms (ng)/milliliter (mL) from Day 28 to Day 364 for Patients With T \<=0.5 ng/mL at Day 28. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||100|93|
71112550|NCT00819156|141732026|SUPERIORITY_OR_OTHER_LEGACY||Percentage|70.0||||||95.0|51.0|85.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||85|51|
71112551|NCT00819156|141732026|SUPERIORITY_OR_OTHER_LEGACY||Percentage|91.0||||||95.0|75.0|98.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||98|75|
71112552|NCT00819156|141732026|SUPERIORITY_OR_OTHER_LEGACY||Percentage|97.0||||||95.0|84.0|100.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||100|84|
71112553|NCT00819156|141732026|SUPERIORITY_OR_OTHER_LEGACY||Percentage|97.0||||||95.0|83.0|100.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||100|83|
71112554|NCT00819156|141732026|SUPERIORITY_OR_OTHER_LEGACY||Percentage|94.0||||||95.0|80.0|99.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||99|80|
71112555|NCT00819156|141732026|SUPERIORITY_OR_OTHER_LEGACY||Percentage|93.0||||||95.0|77.0|99.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||99|77|
70938925|NCT03884478|141378404|OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.19||0.002|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Control Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 4 month follow-up in the Alcohol+Control Arm versus the Control Arm.||||.002
70938926|NCT03884478|141378404|OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.2||0.43|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Alcohol+Control Arm.||||.43
71067985|NCT04075682|141644510|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.56||0.76|TWO_SIDED|95.0|-1.26|0.92||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||0.92|-1.26|0.76
71067986|NCT04075682|141644510|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|0.78||0.15|TWO_SIDED|95.0|-0.42|2.63||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||2.63|-0.42|0.15
71067987|NCT04075682|141644510|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.003|STANDARD_ERROR_OF_MEAN|0.85||1|TWO_SIDED|95.0|-1.66|1.66||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.66|-1.66|1.00
71067988|NCT04075682|141644510|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|0.78||0.01|TWO_SIDED|95.0|0.38|3.43||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||3.43|0.38|0.01
71067989|NCT04075682|141644510|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.62|STANDARD_ERROR_OF_MEAN|1.11||0.58|TWO_SIDED|95.0|-1.56|2.8||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.80|-1.56|0.58
71078954|NCT02798354|141665942|SUPERIORITY||Risk Difference (RD)|20.1|||<|0.0001|TWO_SIDED|95.0|16.2|24.1|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave|||24.1|16.2|<0.0001
71078955|NCT02798354|141665943|SUPERIORITY||Risk Difference (RD)|14.0|||<|0.0001|TWO_SIDED|95.0|10.3|17.7|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave|||17.7|10.3|<0.0001
71078956|NCT02798354|141665944|SUPERIORITY||Risk Difference (RD)|0.1||||0.922|TWO_SIDED|95.0|-1.8|1.9|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, lab test sent, and wave|||1.9|-1.8|0.922
71078957|NCT00528372|141665948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.1522||0.0207||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA|||||||0.0207
71067990|NCT04075682|141644510|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-1.06|STANDARD_ERROR_OF_MEAN|1.23||0.39|TWO_SIDED|95.0|-3.47|1.35||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.35|-3.47|0.39
71067991|NCT04075682|141644510|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.85|STANDARD_ERROR_OF_MEAN|1.12||0.45|TWO_SIDED|95.0|-3.05|1.35||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.35|-3.05|0.45
71067992|NCT04075682|141644510|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.54|STANDARD_ERROR_OF_MEAN|0.34||0.1147|TWO_SIDED|95.0|-0.13|1.21||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.21|-0.13|0.1147
71067993|NCT04075682|141644510|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.44|STANDARD_ERROR_OF_MEAN|0.49||0.3721|TWO_SIDED|95.0|-1.41|0.53||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.53|-1.41|0.3721
71067994|NCT04075682|141644510|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.49||0.8827|TWO_SIDED|95.0|-0.89|1.03||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.03|-0.89|0.8827
71067995|NCT04075682|141644510|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.54|STANDARD_ERROR_OF_MEAN|0.68||0.4335|TWO_SIDED|95.0|-0.8|1.87||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||1.87|-0.80|0.4335
71112556|NCT00819156|141732027|SUPERIORITY_OR_OTHER_LEGACY||Percentage|83.0||||||95.0|65.0|94.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||94|65|
71112557|NCT00819156|141732027|SUPERIORITY_OR_OTHER_LEGACY||Percentage|94.0||||||95.0|79.0|99.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||99|79|
71112558|NCT00819156|141732027|SUPERIORITY_OR_OTHER_LEGACY||Percentage|87.0||||||95.0|70.0|96.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||96|70|
71112559|NCT00819156|141732027|SUPERIORITY_OR_OTHER_LEGACY||Percentage|93.0||||||95.0|78.0|99.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||99|78|
71112560|NCT00819156|141732027|SUPERIORITY_OR_OTHER_LEGACY||Percentage|91.0||||||95.0|76.0|98.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||98|76|
70941851|NCT01855997|141383961|SUPERIORITY_OR_OTHER|||||||1.6e-07|TWO_SIDED||||||t-test, 2 sided|||rs17037122||||0.00000016
70938927|NCT02301299|141378460|OTHER|For power calculation, we assumed that the intervention would be almost fully implemented in May 2016 and the early hospital arrival would be observed until Dec 2017. Therefore, a post-intervention period would be 20 months. To have one-third of the study period as an intervention period, we planned to analyze five-year (60-month) data from January 2013 to December 2017.|||||<|0.0001|||||||Regression, Linear|Using the seasonally adjusted time series data, we conducted linear regression analysis for time series data in PROC AUTOREG.||The effect size was defined as the sum of expected slope change in monthly early hospital arrival rate over the standard deviation. Assuming an autocorrelation level of 0.3, both level and trend change effect size of 0.5 would be detectable at 90% power at a significance level of 0.05.|Using SAS PROC TIMESERIES, individual admission data were aggregated into monthly time series data to calculate a monthly early arrival rate. In this procedure, we also generated seasonally adjusted time series data to take into account a seasonal pattern. Using the seasonally adjusted time series data, we conducted linear regression analysis for time series data in PROC AUTOREG. The statistical hypothesis of the regression model was that there are a level change and a slope change after the intervention. In the regression model, we included a time variable to account for a natural trend prior to the intervention introduction (or in absence of the intervention). We assumed that the patient population was stable during the five-year period and no other factors than the intervention affected the outcome; no other potential confounding factors were not considered. A backward elimination was used to correct for autocorrelation. Maximum likelihood method was used to estimate parameters.|||<.0001
70941852|NCT01855997|141383962|SUPERIORITY_OR_OTHER|||||||8.8e-07|TWO_SIDED||||||t-test, 2 sided|||rs17037122||||0.00000088
71067996|NCT04075682|141644510|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.62|STANDARD_ERROR_OF_MEAN|0.74||0.4063|TWO_SIDED|95.0|-2.07|0.84||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||0.84|-2.07|0.4063
71067997|NCT04075682|141644510|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.69|STANDARD_ERROR_OF_MEAN|0.68||0.0132|TWO_SIDED|95.0|0.35|3.03||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||3.03|0.35|0.0132
71067998|NCT04075682|141644510|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.83|STANDARD_ERROR_OF_MEAN|0.98||0.3949|TWO_SIDED|95.0|-1.08|2.75||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.75|-1.08|0.3949
71067999|NCT04075682|141644510|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.39|STANDARD_ERROR_OF_MEAN|1.08||0.7145|TWO_SIDED|95.0|-2.5|1.72||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.72|-2.50|0.7145
71068000|NCT04075682|141644510|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.98||0.6081|TWO_SIDED|95.0||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||||0.6081
71078958|NCT00528372|141665948|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.1541||0.0005||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA|||||||0.0005
71078959|NCT00528372|141665948|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.1518|<|0.0001||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA|||||||<0.0001
70941853|NCT01855997|141383963|SUPERIORITY_OR_OTHER|||||||8.79e-06|TWO_SIDED||||||t-test, 2 sided|||rs2464266||||0.00000879
71068001|NCT04075682|141644511|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.46||0.58|TWO_SIDED|95.0|-1.15|0.64||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.64|-1.15|0.58
71068002|NCT04075682|141644511|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.9||0.82|TWO_SIDED|95.0|-1.98|1.57||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4)||1.57|-1.98|0.82
71068003|NCT04075682|141644511|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.67|STANDARD_ERROR_OF_MEAN|1.31||0.2|TWO_SIDED|95.0|-0.9|4.24||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||4.24|-0.90|0.20
71068004|NCT04075682|141644511|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.36||0.88|TWO_SIDED|95.0|-0.77|0.66||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation analysis are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.66|-0.77|0.8800
71068005|NCT04075682|141644511|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Median Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.72||0.8864|TWO_SIDED|95.0|-1.3|1.5||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4)||1.50|-1.30|0.8864
71078960|NCT00528372|141665948|SUPERIORITY_OR_OTHER||Difference from placebo|-0.61|STANDARD_ERROR_OF_MEAN|0.1536|||TWO_SIDED|95.0|-0.91|-0.3||||||||-0.30|-0.91|
71078961|NCT00528372|141665948|SUPERIORITY_OR_OTHER||Difference from placebo|-0.56|STANDARD_ERROR_OF_MEAN|0.1527|||TWO_SIDED|95.0|-0.86|-0.26||||||||-0.26|-0.86|
71078962|NCT00528372|141665948|SUPERIORITY_OR_OTHER||Difference from placebo|-0.56|STANDARD_ERROR_OF_MEAN|0.1474|||TWO_SIDED|95.0|-0.85|-0.27||||||||-0.27|-0.85|
71078963|NCT00528372|141665949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.1|STANDARD_ERROR_OF_MEAN|5.734||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.|||Week 24|||||
71078964|NCT00528372|141665949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.9|STANDARD_ERROR_OF_MEAN|5.806||0.0007||||||Statistically significant according to hierarchical testing procedure (p\<0.05)|ANCOVA||Week 24|||||0.0007
71078965|NCT00528372|141665949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.7|STANDARD_ERROR_OF_MEAN|5.626|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05)|ANCOVA||Week 24|||||<0.0001
71078966|NCT00528372|141665949|SUPERIORITY_OR_OTHER||Difference from placebo|-21.5|STANDARD_ERROR_OF_MEAN|5.686|||TWO_SIDED|95.0|-32.6|-10.3||||||||-10.3|-32.6|
71078967|NCT00528372|141665949|SUPERIORITY_OR_OTHER||Difference from placebo|-23.3|STANDARD_ERROR_OF_MEAN|5.711|||TWO_SIDED|95.0|-34.4|-12.0||||||||-12.0|-34.4|
71078968|NCT00528372|141665949|SUPERIORITY_OR_OTHER||Difference from placebo|-25.5|STANDARD_ERROR_OF_MEAN|5.567|||TWO_SIDED|95.0|-36.4|-14.5||||||||-14.5|-36.4|
71078969|NCT00528372|141665951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.06|STANDARD_ERROR_OF_MEAN|0.6307||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.||||||||
71078970|NCT00528372|141665951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.6388||0.3101||||||Tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||||0.3101
70941854|NCT01855997|141383964|SUPERIORITY_OR_OTHER|||||||4.52e-06|TWO_SIDED||||||t-test, 2 sided|||rs9496139||||0.00000452
70941855|NCT01855997|141383964|SUPERIORITY_OR_OTHER|||||||4.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs2014238||||0.00000497
70941856|NCT01855997|141383964|SUPERIORITY_OR_OTHER|||||||4.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs2980231||||0.00000497
71068006|NCT04075682|141644511|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.12|STANDARD_ERROR_OF_MEAN|1.02||0.2748|TWO_SIDED|95.0|-0.89|3.12||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||3.12|-0.89|0.2748
71068007|NCT04075682|141644512|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.1|STANDARD_ERROR_OF_MEAN|0.5||0.83|TWO_SIDED|95.0|0.45|2.7||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be lower in the insert groups than in the no insert groups.||2.70|0.45|0.83
71068008|NCT04075682|141644512|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.86|STANDARD_ERROR_OF_MEAN|1.34||0.03|TWO_SIDED|95.0|1.14|7.18||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||7.18|1.14|0.03
71078971|NCT00528372|141665951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.6223||0.1189||||||Tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||||0.1189
70941857|NCT01855997|141383965|SUPERIORITY_OR_OTHER|||||||7.48e-06|TWO_SIDED||||||t-test, 2 sided|||exm2237722||||0.00000748
70941858|NCT01855997|141383965|SUPERIORITY_OR_OTHER|||||||7.3e-07|TWO_SIDED||||||t-test, 2 sided|||rs16924016||||0.00000073
70941859|NCT01855997|141383965|SUPERIORITY_OR_OTHER|||||||2.89e-06|TWO_SIDED||||||t-test, 2 sided|||rs2899723||||0.00000289
70941860|NCT01855997|141383965|SUPERIORITY_OR_OTHER|||||||9.12e-06|TWO_SIDED||||||t-test, 2 sided|||rs8027115||||0.00000912
70941861|NCT01855997|141383965|SUPERIORITY_OR_OTHER|||||||4.94e-06|TWO_SIDED||||||t-test, 2 sided|||exm2267780||||0.00000494
71068009|NCT04075682|141644512|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.53|STANDARD_ERROR_OF_MEAN|0.27||0.18|TWO_SIDED|95.0|0.15|1.44||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be lower in the insert and pictorial warning group than in the pictorial warning only group.||1.44|0.15|0.18
71068010|NCT04075682|141644512|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.01|STANDARD_ERROR_OF_MEAN|1.3||0.99|TWO_SIDED|95.0|0.08|12.57||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be lower for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||12.57|0.08|0.99
71068011|NCT04075682|141644512|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.52||0.86|TWO_SIDED|95.0|0.29|2.82||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.||These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||2.82|0.29|0.86
71068012|NCT04075682|141644512|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.1|STANDARD_ERROR_OF_MEAN|0.43||0.8045|TWO_SIDED|||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be lower in the insert groups than in the no insert groups.||||0.8045
71068013|NCT04075682|141644512|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.53|STANDARD_ERROR_OF_MEAN|1.01||0.0205|TWO_SIDED|||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||||0.0205
71068014|NCT04075682|141644512|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.53|STANDARD_ERROR_OF_MEAN|0.26||0.1918|TWO_SIDED|||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be lower in the insert and pictorial warning group than in the pictorial warning only group.||||0.1918
71078608|NCT01441245|141665090|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.01|TWO_SIDED||||||t-test, 2 sided|||Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values \<0.05 were considered significant.||||0.01
71078972|NCT00528372|141665951|SUPERIORITY_OR_OTHER||Difference from placebo|-1.63|STANDARD_ERROR_OF_MEAN|0.6254|||TWO_SIDED|95.0|-2.86|-0.41||||||||-0.41|-2.86|
71078973|NCT00528372|141665951|SUPERIORITY_OR_OTHER||Difference from placebo|-1.36|STANDARD_ERROR_OF_MEAN|0.6279|||TWO_SIDED|95.0|-2.6|-0.13||||||||-0.13|-2.60|
71078974|NCT00528372|141665951|SUPERIORITY_OR_OTHER||Difference from placebo|-0.87|STANDARD_ERROR_OF_MEAN|0.6103|||TWO_SIDED|95.0|-2.06|0.33||||||||0.33|-2.06|
71078975|NCT00528372|141665953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|4.324||||||||||||||||
71078976|NCT00528372|141665953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.9|STANDARD_ERROR_OF_MEAN|4.342||||||||||||||||
70941862|NCT01855997|141383966|SUPERIORITY_OR_OTHER|||||||6.27e-06|TWO_SIDED||||||t-test, 2 sided|||rs9973954||||0.00000627
70941863|NCT01855997|141383966|SUPERIORITY_OR_OTHER|||||||6.96e-06|TWO_SIDED||||||t-test, 2 sided|||exm2237722||||0.00000696
71112561|NCT00819156|141732027|SUPERIORITY_OR_OTHER_LEGACY||Percentage|93.0||||||95.0|78.0|99.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||99|78|
71112562|NCT00819156|141732028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0933||95.0|||||Log Rank|||||||0.0933
71112563|NCT00819156|141732029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.165||95.0|||||Log Rank|||||||0.165
71112564|NCT00819156|141732030|SUPERIORITY_OR_OTHER_LEGACY|||||||0.429||95.0|||||Log Rank|||||||0.429
71112565|NCT01575808|141732047|SUPERIORITY_OR_OTHER_LEGACY||Percentage|91.0|||<|0.0001|ONE_SIDED|95.0|86.3||||z-test|One-sided z-test||A literature-based Surgical Bypass Efficacy Goal of 65% was compared to the percentage of subjects maintaining primary assisted patency at 12 months. A one-sided z-test using a Type I error of 5% was performed to test the hypotheses that the 12-month primary assisted patency probability of GP1101 is superior to the SBEG of 65%.|||86.3|<0.0001
71112566|NCT01575808|141732048|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Hypothesis is that the post-procedure hospital stay duration for GP1101 is superior to the post-procedure hospital stay for the retrospective surgical bypass group.||||<0.0001
70941864|NCT01855997|141383966|SUPERIORITY_OR_OTHER|||||||4.26e-06|TWO_SIDED||||||t-test, 2 sided|||rs1040084||||0.00000426
70941865|NCT01855997|141383966|SUPERIORITY_OR_OTHER|||||||4.35e-06|TWO_SIDED||||||t-test, 2 sided|||rs1913484||||0.00000435
71112567|NCT01575808|141732049|SUPERIORITY_OR_OTHER_LEGACY||Percentage|100.0|||<|0.0001|TWO_SIDED|95.0|96.5|100.0|||Fisher Exact||Confidence interval calculated with binomial exact method.|The hypothesis is that the rate of avoidance of general anesthesia for GP1101 is superior to the rate of avoidance of general anesthesis for the retrospective surgical bypass group.||100|96.5|<0.0001
71112568|NCT01575808|141732050|SUPERIORITY_OR_OTHER_LEGACY||Percentage|100.0|||||TWO_SIDED|95.0|96.5|100.0|||||Confidence intervals calculated using the binomial exact method.|||100.0|96.5|
71112569|NCT01575808|141732080|OTHER||Percentage|97.1|||||TWO_SIDED|95.0|91.7|99.4||||||||99.4|91.7|
71112570|NCT01575808|141732100|OTHER||Percentage|100.0|||||TWO_SIDED|95.0|96.5|100.0|||||Confidence Interval calculated with binomial exact method.|||100.0|96.5|
71112571|NCT03292874|141732142|SUPERIORITY|||||||0.014||||||"Areas under the receiver operating characteristics curve (AUC) were compared between models with standard and high-resolution MRI variables using the nonparametric method described by DeLong.~DeLong. Biometrics 1988;44(3):837-45."|nonparametric method|||||||0.014
71112572|NCT00485758|141732155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.9|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-21.4|-14.4|||Wilcoxon (Mann-Whitney)|Study times: 4, 8 and 12 weeks. Terms: treatment-by-time, gender-by-time and baseline low-density lipoprotein cholesterol -by-time interaction.||||-14.4|-21.4|<0.001
71112573|NCT00485758|141732156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.2|STANDARD_ERROR_OF_MEAN|1.3|<|0.001||95.0|20.7|25.7|||Repeated Measures Analysis|Study times: 4, 8 and 12 weeks. Terms: treatment-by-time, gender-by-time and baseline high-density lipoprotein cholesterol -by-time interaction.||||25.7|20.7|<0.001
71112574|NCT00485758|141732157|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-23.1|||<|0.001||95.0|-27.2|-18.9|||ANCOVA|Nonparametric Analysis of Covariance model based on Tukey's normalized ranks with term for treatment, gender and Tukey's normal score of baseline.|The median difference between treatments is based on the Hodges-Lehmann estimates of shift with a corresponding distribution-free Confidence Interval based on Wilcoxon's rank|||-18.9|-27.2|<0.001
71112575|NCT00654745|141732158|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.9|||<|0.0001|TWO_SIDED|95.0|-21.5|-18.4|||t-test, 2 sided|||||-18.4|-21.5|<0.0001
71112576|NCT00654745|141732159|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.2|||<|0.0001|TWO_SIDED|95.0|-12.2|-10.3||24-hour mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-10.3|-12.2|<0.0001
71112577|NCT00654745|141732159|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.7|||<|0.0001|TWO_SIDED|95.0|-12.9|-10.5||daytime mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-10.5|-12.9|<0.0001
71112578|NCT00654745|141732159|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.4|||<|0.0001|TWO_SIDED|95.0|-11.7|-9.0||nighttime mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-9.0|-11.7|<0.0001
71112579|NCT00654745|141732159|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.9|||<|0.0001|TWO_SIDED|95.0|-12.2|-9.7||last 6 hours mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-9.7|-12.2|<0.0001
71117745|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-34.56|||<|0.001|TWO_SIDED|95.0|-51.77|-17.35||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-17.35|-51.77|<0.001
70941866|NCT01855997|141383966|SUPERIORITY_OR_OTHER|||||||2.21e-06|TWO_SIDED||||||t-test, 2 sided|||rs16924016||||0.00000221
70941867|NCT01855997|141383966|SUPERIORITY_OR_OTHER|||||||5.23e-06|TWO_SIDED||||||t-test, 2 sided|||exm1010813||||0.00000523
70941868|NCT01855997|141383966|SUPERIORITY_OR_OTHER|||||||7.57e-06|TWO_SIDED||||||t-test, 2 sided|||rs6576456||||0.00000757
70941869|NCT01855997|141383967|SUPERIORITY_OR_OTHER|||||||1.53e-06|TWO_SIDED||||||t-test, 2 sided|||rs17037122||||0.00000153
70941870|NCT01855997|141383967|SUPERIORITY_OR_OTHER|||||||7.08e-06|TWO_SIDED||||||t-test, 2 sided|||rs10475403||||0.00000708
71068015|NCT04075682|141644512|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.03|STANDARD_ERROR_OF_MEAN|1.12||0.99|TWO_SIDED|||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be lower for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||||0.99
71068016|NCT04075682|141644512|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.56|STANDARD_ERROR_OF_MEAN|1.54||0.6873|TWO_SIDED|||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||||0.6873
71068017|NCT04075682|141644513|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.35|STANDARD_ERROR_OF_MEAN|0.39||0.37|TWO_SIDED|95.0|-1.12|0.41||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.41|-1.12|0.37
71068018|NCT04075682|141644514|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.99|STANDARD_ERROR_OF_MEAN|0.05||0.92|TWO_SIDED|95.0|0.9|1.1||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.10|0.90|0.92
71078977|NCT00528372|141665953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.6|STANDARD_ERROR_OF_MEAN|4.176||||||||||||||||
71078978|NCT00528372|141665953|SUPERIORITY_OR_OTHER||Difference from placebo|-12.0|STANDARD_ERROR_OF_MEAN|4.223|||TWO_SIDED|95.0|-20.3|-3.7||||||||-3.7|-20.3|
71078979|NCT00528372|141665953|SUPERIORITY_OR_OTHER||Difference from placebo|-16.2|STANDARD_ERROR_OF_MEAN|4.321|||TWO_SIDED|95.0|-24.7|-7.7||||||||-7.7|-24.7|
70941871|NCT01855997|141383967|SUPERIORITY_OR_OTHER|||||||7.27e-06|TWO_SIDED||||||t-test, 2 sided|||rs715243||||0.00000727
71078980|NCT00528372|141665953|SUPERIORITY_OR_OTHER||Difference from placebo|-17.9|STANDARD_ERROR_OF_MEAN|4.228|||TWO_SIDED|95.0|-26.2|-9.5||||||||-9.5|-26.2|
71078981|NCT00528372|141665955|SUPERIORITY_OR_OTHER||Percentage difference|9.7||||||||||||||||||
71078982|NCT00528372|141665955|SUPERIORITY_OR_OTHER||Percentage difference|12.6||||||||||||||||||
71078983|NCT00528372|141665955|SUPERIORITY_OR_OTHER||Percentage difference|19.2||||||||||||||||||
71078984|NCT00528372|141665955|SUPERIORITY_OR_OTHER||Percent difference from placebo|19.8|||||TWO_SIDED|95.0|4.9|34.7||||||||34.7|4.9|
71078985|NCT00528372|141665955|SUPERIORITY_OR_OTHER||Percent difference from placebo|12.4|||||TWO_SIDED|95.0|-2.5|27.3||||||||27.3|-2.5|
71078986|NCT00528372|141665955|SUPERIORITY_OR_OTHER||Percent difference from placebo|19.9|||||TWO_SIDED|95.0|5.3|34.5||||||||34.5|5.3|
71078987|NCT00528372|141665956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|0.6979||||||||||||||||
71078988|NCT00528372|141665956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.19|STANDARD_ERROR_OF_MEAN|0.6828||||||||||||||||
71078989|NCT00528372|141665956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.23|STANDARD_ERROR_OF_MEAN|0.6404||||||||||||||||
71078990|NCT00528372|141665956|SUPERIORITY_OR_OTHER||Difference from placebo|-1.55|STANDARD_ERROR_OF_MEAN|0.7394|||TWO_SIDED|95.0|-3.33|-0.42||||||||-0.42|-3.33|
71078991|NCT00528372|141665956|SUPERIORITY_OR_OTHER||Difference from placebo|-1.27|STANDARD_ERROR_OF_MEAN|0.7257|||TWO_SIDED|95.0|-2.69|0.16||||||||0.16|-2.69|
71078992|NCT00528372|141665956|SUPERIORITY_OR_OTHER||Difference from placebo|-0.87|STANDARD_ERROR_OF_MEAN|0.6103|||TWO_SIDED|95.0|-2.06|0.33||||||||0.33|-2.06|
71078993|NCT00528372|141665957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.175||||||||||||||||
71078994|NCT00528372|141665957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.175||||||||||||||||
71078995|NCT00528372|141665957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.1708||||||||||||||||
71078996|NCT00528372|141665957|SUPERIORITY_OR_OTHER||Difference from placebo|-0.6|STANDARD_ERROR_OF_MEAN|0.1798|||TWO_SIDED|95.0|-0.95|-0.25||||||||-0.25|-0.95|
70941872|NCT01855997|141383968|SUPERIORITY_OR_OTHER|||||||3.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs17037122||||0.00000397
70941873|NCT01855997|141383969|SUPERIORITY_OR_OTHER|||||||6.86e-06|TWO_SIDED||||||t-test, 2 sided|||rs6443144||||0.00000686
70941874|NCT01855997|141383969|SUPERIORITY_OR_OTHER|||||||5.96e-06|TWO_SIDED||||||t-test, 2 sided|||rs2189452||||0.00000596
71068019|NCT04075682|141644514|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|1.0|STANDARD_ERROR_OF_MEAN|0.05||0.95|TWO_SIDED|95.0|0.9|1.11||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||1.11|0.90|0.95
71068020|NCT04075682|141644514|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.99|STANDARD_ERROR_OF_MEAN|0.08||0.85|TWO_SIDED|95.0|0.85|1.14||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||1.14|0.85|0.85
71068021|NCT04075682|141644514|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.98|STANDARD_ERROR_OF_MEAN|0.07||0.75|TWO_SIDED|95.0|0.84|1.13||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.13|0.84|0.75
71068022|NCT04075682|141644514|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.97|STANDARD_ERROR_OF_MEAN|0.11||0.78|TWO_SIDED|95.0|0.78|1.2||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4)||1.20|0.78|0.78
71068023|NCT04075682|141644514|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|1.31|STANDARD_ERROR_OF_MEAN|0.22||0.11|TWO_SIDED|95.0|0.94|1.82||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||1.82|0.94|0.11
71068024|NCT04075682|141644514|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.99|STANDARD_ERROR_OF_MEAN|0.11||0.93|TWO_SIDED|95.0|0.8|1.22||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||1.22|0.80|0.93
71078609|NCT01441245|141665091|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.05|TWO_SIDED||||||t-test, 2 sided|||Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values \<0.05 were considered significant||||0.05
71112580|NCT00654745|141732159|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.1|||<|0.0001|TWO_SIDED|95.0|-12.4|-9.8||last 4 hours mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-9.8|-12.4|<0.0001
71068025|NCT04075682|141644514|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.98|STANDARD_ERROR_OF_MEAN|0.11||0.86|TWO_SIDED|95.0|0.78|1.23||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.23|0.78|0.86
71068026|NCT04075682|141644514|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.99|STANDARD_ERROR_OF_MEAN|0.11||0.94|TWO_SIDED|95.0|0.81|1.22||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||1.22|0.81|0.94
71068027|NCT04075682|141644514|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|1.29|STANDARD_ERROR_OF_MEAN|0.21||0.13|TWO_SIDED|95.0|0.93|1.78||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.78|0.93|0.13
71068028|NCT04075682|141644514|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.99|STANDARD_ERROR_OF_MEAN|0.18||0.96|TWO_SIDED|95.0|0.7|1.41||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.41|0.70|0.96
71068029|NCT04075682|141644514|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.99|STANDARD_ERROR_OF_MEAN|0.16||0.95|TWO_SIDED|95.0|0.72|1.36||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.36|0.72|0.95
71068030|NCT00497289|141644533|SUPERIORITY|||||||0.3654|||||||Wilcoxon (Mann-Whitney)|||||||0.3654
71068031|NCT00497289|141644534|SUPERIORITY|||||||0.0264|||||||Wilcoxon (Mann-Whitney)|||||||0.0264
71068032|NCT03200704|141644542|NON_INFERIORITY|90% power, 2.5% one-sided significance level,5% non-inferiority margin|||||<|0.0001|||||||Regression, Logistic|||"Hypothesis:~H0: QT ≤ QC - 0.05 H1: QT \> QC - 0.05"||||<0.0001
71068033|NCT00778869|141644546|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Student t-test|||||||<0.05
71078997|NCT00528372|141665957|SUPERIORITY_OR_OTHER||Difference from placebo|-0.55|STANDARD_ERROR_OF_MEAN|0.1741|||TWO_SIDED|95.0|-0.89|-0.21||||||||-0.21|-0.89|
71078998|NCT00528372|141665957|SUPERIORITY_OR_OTHER||Difference from placebo|-0.58|STANDARD_ERROR_OF_MEAN|0.1704|||TWO_SIDED|95.0|-0.92|-0.25||||||||-0.25|-0.92|
71078999|NCT00528372|141665958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.6|STANDARD_ERROR_OF_MEAN|6.526||||||||||||||||
71079000|NCT00528372|141665958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.1|STANDARD_ERROR_OF_MEAN|6.761||||||||||||||||
71079001|NCT00528372|141665958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|6.334||||||||||||||||
71079002|NCT00528372|141665958|SUPERIORITY_OR_OTHER||Percent difference from placebo|18.8|||||TWO_SIDED|95.0|5.5|32.1||||||||32.1|5.5|
71079003|NCT00528372|141665958|SUPERIORITY_OR_OTHER||Percent difference from placebo|11.3|||||TWO_SIDED|95.0|-1.8|24.4||||||||24.4|-1.8|
71079004|NCT00528372|141665958|SUPERIORITY_OR_OTHER||Percent difference from placebo|11.4|||||TWO_SIDED|95.0|-1.0|23.9||||||||23.9|-1.0|
70941875|NCT01855997|141383969|SUPERIORITY_OR_OTHER|||||||4.89e-06|TWO_SIDED||||||t-test, 2 sided|||rs9324018||||0.00000489
71079005|NCT00528372|141665959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.736||||||||||||||||
71079006|NCT00528372|141665959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.7371||||||||||||||||
70941876|NCT01855997|141383970|SUPERIORITY_OR_OTHER|||||||8.34e-06|TWO_SIDED||||||t-test, 2 sided|||rs2189452||||0.00000834
71068034|NCT01218087|141644552|NON_INFERIORITY_OR_EQUIVALENCE|Following the first interim analysis of the first 40 infants, the sample size calculation was revised. A revised sample size of 62 infants (31 per treatment arm) was based on an observed reduction of 41% to 11% in the experimental group with a goal p value of 0.01.||||||0.03|TWO_SIDED||||||Fisher Exact|||||||0.03
71068035|NCT03425396|141644604|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-3.5|||||TWO_SIDED|95.0|-16.8|9.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||9.6|-16.8|
71068036|NCT03425396|141644604|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-13.0|||||TWO_SIDED|95.0|-27.4|1.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||1.2|-27.4|
71068037|NCT03425396|141644604|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-5.6|||||TWO_SIDED|95.0|-19.6|7.4|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||7.4|-19.6|
71068038|NCT03425396|141644604|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-3.2|||||TWO_SIDED|95.0|-44.1|14.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.7|-44.1|
71068039|NCT03425396|141644605|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-1.6|||||TWO_SIDED|95.0|-14.3|11.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||11.2|-14.3|
71068040|NCT03425396|141644605|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-3.7|||||TWO_SIDED|95.0|-16.8|9.0|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||9.0|-16.8|
71068041|NCT03425396|141644605|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|0.0|||||TWO_SIDED|95.0|-12.3|12.3|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||12.3|-12.3|
70941877|NCT01855997|141383970|SUPERIORITY_OR_OTHER|||||||4.87e-06|TWO_SIDED||||||t-test, 2 sided|||rs7968170||||0.00000487
70941878|NCT01855997|141383970|SUPERIORITY_OR_OTHER|||||||9.18e-06|TWO_SIDED||||||t-test, 2 sided|||rs9324018||||0.00000918
70941879|NCT01855997|141383971|SUPERIORITY_OR_OTHER|||||||1.37e-06|TWO_SIDED||||||t-test, 2 sided|||rs9287655||||0.00000137
71068042|NCT03425396|141644605|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-3.2|||||TWO_SIDED|95.0|-44.1|14.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.7|-44.1|
71068043|NCT03425396|141644606|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-2.0|||||TWO_SIDED|95.0|-22.5|16.8|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||16.8|-22.5|
71068044|NCT03425396|141644606|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-4.7|||||TWO_SIDED|95.0|-23.3|14.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.2|-23.3|
71068045|NCT03425396|141644606|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|5.7|||||TWO_SIDED|95.0|-13.0|22.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||22.6|-13.0|
71068046|NCT03425396|141644606|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|10.0|||||TWO_SIDED|95.0|-40.4|28.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||28.9|-40.4|
71068047|NCT03425396|141644607|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|1.7|||||TWO_SIDED|95.0|-10.0|13.4|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||13.4|-10.0|
71112581|NCT00654745|141732159|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.5|||<|0.0001|TWO_SIDED|95.0|-13.1|-10.0||last 2 hours mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-10.0|-13.1|<0.0001
71112582|NCT00654745|141732160|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.8|||<|0.0001|TWO_SIDED|95.0|-22.6|-18.9||daytime mean SBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-18.9|-22.6|<0.0001
70941880|NCT01855997|141383971|SUPERIORITY_OR_OTHER|||||||3.39e-06|TWO_SIDED||||||t-test, 2 sided|||rs2803073||||0.00000339
70941881|NCT01855997|141383971|SUPERIORITY_OR_OTHER|||||||9.27e-06|TWO_SIDED||||||t-test, 2 sided|||rs1937590||||0.00000927
70941882|NCT01855997|141383971|SUPERIORITY_OR_OTHER|||||||1.66e-06|TWO_SIDED||||||t-test, 2 sided|||rs2945861||||0.00000166
71068048|NCT03425396|141644607|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%|Treatment difference|-2.9|||||TWO_SIDED|95.0|-16.2|9.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||9.7|-16.2|
71068049|NCT03425396|141644607|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%|Treatment Difference|7.7|||||TWO_SIDED|95.0|-0.3|18.5|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||18.5|-0.3|
71068050|NCT03425396|141644607|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatm,ent difference|7.7|||||TWO_SIDED|95.0|-34.9|20.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||20.6|-34.9|
71068051|NCT03425396|141644608|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%|Treatment difference|0.0|||||TWO_SIDED|95.0|-12.6|12.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||12.6|-12.6|
71068052|NCT03425396|141644608|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-2.7|||||TWO_SIDED|95.0|-16.3|10.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||10.2|-16.3|
71112583|NCT00654745|141732160|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-18.5|||<|0.0001|TWO_SIDED|95.0|-20.4|-16.6||nighttime mean SBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-16.6|-20.4|<0.0001
71112584|NCT00654745|141732160|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-18.9|||<|0.0001|TWO_SIDED|95.0|-20.7|-17.0||last 6 hours mean SBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-17.0|-20.7|<0.0001
71068053|NCT03425396|141644608|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|6.0|||||TWO_SIDED|95.0|-4.5|17.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated|||17.7|-4.5|
71068054|NCT03425396|141644608|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|8.2|||||TWO_SIDED|95.0|-35.3|20.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||20.7|-35.3|
71068055|NCT03425396|141644609|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%|Treatment difference|-6.0|||||TWO_SIDED|95.0|-27.3|13.3|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||13.3|-27.3|
71112585|NCT00654745|141732160|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.1|||<|0.0001|TWO_SIDED|95.0|-21.1|-17.1||last 4 hours mean SBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-17.1|-21.1|<0.0001
70941883|NCT01855997|141383971|SUPERIORITY_OR_OTHER|||||||4.55e-06|TWO_SIDED||||||t-test, 2 sided|||rs1997894||||0.00000455
70941884|NCT01855997|141383971|SUPERIORITY_OR_OTHER|||||||5.68e-06|TWO_SIDED||||||t-test, 2 sided|||rs1495471||||0.00000568
70941885|NCT01855997|141383971|SUPERIORITY_OR_OTHER|||||||1.25e-06|TWO_SIDED||||||t-test, 2 sided|||rs9324018||||0.00000125
70941886|NCT01855997|141383971|SUPERIORITY_OR_OTHER|||||||9.82e-06|TWO_SIDED||||||t-test, 2 sided|||rs1152537||||0.00000982
71068056|NCT03425396|141644609|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-10.6|||||TWO_SIDED|95.0|-29.2|8.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||8.6|-29.2|
71068057|NCT03425396|141644609|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment Difference|1.3|||||TWO_SIDED|95.0|-19.0|19.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||19.2|-19.0|
71068058|NCT03425396|141644609|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|10.0|||||TWO_SIDED|95.0|-40.4|28.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||28.9|-40.4|
71068059|NCT03425396|141644610|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-5.3|||||TWO_SIDED|95.0|-18.6|7.8|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||7.8|-18.6|
71068060|NCT03425396|141644610|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-14.8|||||TWO_SIDED|95.0|-29.6|-0.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||-0.6|-29.6|
71068061|NCT03425396|141644610|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-9.3|||||TWO_SIDED|95.0|-23.2|4.4|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||4.4|-23.2|
71068062|NCT03425396|141644610|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-3.2|||||TWO_SIDED|95.0|-44.1|14.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.7|-44.1|
71068063|NCT03425396|141644611|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-0.3|||||TWO_SIDED|95.0|-13.1|12.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||12.7|-13.1|
70941887|NCT01855997|141383972|SUPERIORITY_OR_OTHER|||||||8.46e-06|TWO_SIDED||||||t-test, 2 sided|||rs10236906||||0.00000846
71068064|NCT03425396|141644611|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-5.8|||||TWO_SIDED|95.0|-20.7|7.8|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||7.8|-20.7|
71068065|NCT03425396|141644611|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-1.1|||||TWO_SIDED|95.0|-15.1|11.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||11.6|-15.1|
71068066|NCT03425396|141644611|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|8.2|||||TWO_SIDED|95.0|-35.3|20.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||20.7|-35.3|
71068067|NCT03425396|141644612|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-6.0|||||TWO_SIDED|95.0|-27.3|13.3|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated|||13.3|-27.3|
71079007|NCT00528372|141665959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|0.7078||||||||||||||||
70941888|NCT01855997|141383972|SUPERIORITY_OR_OTHER|||||||5.62e-06|TWO_SIDED||||||t-test, 2 sided|||rs2945861||||0.00000562
70941889|NCT01855997|141383972|SUPERIORITY_OR_OTHER|||||||4.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs7042473||||0.00000497
71079008|NCT00528372|141665959|SUPERIORITY_OR_OTHER||Difference from placebo|-1.87|STANDARD_ERROR_OF_MEAN|0.7394|||TWO_SIDED|95.0|-3.33|-0.42||||||||-0.42|-3.33|
71079009|NCT00528372|141665959|SUPERIORITY_OR_OTHER||Difference from placebo|-1.27|STANDARD_ERROR_OF_MEAN|0.7257|||TWO_SIDED|95.0|-2.69|0.16||||||||0.16|-2.69|
71079010|NCT00528372|141665959|SUPERIORITY_OR_OTHER||Difference from placebo|-0.97|STANDARD_ERROR_OF_MEAN|0.7135||||95.0|-2.37|0.44||||||||0.44|-2.37|
71079011|NCT02774005|141665974|SUPERIORITY||Odds Ratio (OR)|2.286||||0.0021|TWO_SIDED|95.0|1.352|3.884|||Wald Chi-square|||||3.884|1.352|0.0021
71079012|NCT02774005|141665975|SUPERIORITY||Odds Ratio (OR)|1.646||||0.0873|TWO_SIDED|95.0|0.929|2.918|||Waldi-Chi-Square|||||2.918|0.929|0.0873
71079013|NCT02774005|141665976|SUPERIORITY||Odds Ratio (OR)|7.323||||0.0005|TWO_SIDED|95.0|2.339|25.912|||Waldi-Chi-Square|||||25.912|2.339|0.0005
71079014|NCT03275389|141666027|EQUIVALENCE|The use of the adjuvant (AS03) is to be considered justified if the lower limit of the 94.46% CI of the GMC ratio (adjuvanted vs non-adjuvanted) is \> 1.50|GMC ratio|2.47|||||TWO_SIDED|94.46|2.06|2.95|||Dunnett's t test|Comparison performed using a 2-sided alpha=0.1 and Dunnett adjustment for multiple comparisons,||To evaluate the adjuvant effect of AS03 (Pooling of results at Day 29 of D-SUIV Adjuvant Group 1, at Day 29 of D-SUIV Adjuvant Group 2 and Day 85 of D-SUIV Adjuvant Group 3) on the humoral immune response for anti-H1 stalk antibody by ELISA at Day 29 and Day 85 (i.e. 28 days post-vaccination) when compared to the non-adjuvanted formulations (Pooling of results at Day 29 of D-SUIV Unadjuvanted Group 1, at Day 29 of D-SUIV Unadjuvanted Group 2 and Day 85 of D-SUIV Unadjuvanted Group 3).||2.95|2.06|
71079015|NCT03275389|141666027|EQUIVALENCE|The use of the adjuvant (AS01) is to be considered justified if the lower limit of the 94.46% CI of the GMC ratio (adjuvanted vs non-adjuvanted) is \> 1.50|GMC ratio|1.75|||||TWO_SIDED|94.46|1.46|2.1|||Dunnett's t test|Comparison performed using a 2-sided alpha=0.1 and Dunnett adjustment for multiple comparisons,||To evaluate the adjuvant effect of AS01 (Pooling of results at Day 29 of D-SUIV Adjuvant Group 4, at Day 29 of D-SUIV Adjuvant Group 5 and Day 85 of D-SUIV Adjuvant Group 6) on the humoral immune response for anti-H1 stalk antibody by ELISA at Day 29 and Day 85 (i.e. 28 days post-vaccination) when compared to the non-adjuvanted formulations (Pooling of results at Day 29 of D-SUIV Unadjuvanted Group 1, at Day 29 of D-SUIV Unadjuvanted Group 2 and Day 85 of D-SUIV Unadjuvanted Group 3).||2.1|1.46|
71079016|NCT02379273|141666043|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p = 0.05.|ANOVA|||A Friedman repeated-measures ANOVA on ranks was applied to the unilateral CNC data with follow-up pairwise comparisons based on the Tukey Test.||||<0.001
71079017|NCT02379273|141666043|SUPERIORITY|A Friedman repeated-measures ANOVA on ranks was applied to the bilateral CNC data with follow-up pairwise comparisons based on the Tukey Test.|||||<|0.001||||||The threshold for statistical significance was p = 0.05.|ANOVA|||||||<0.001
71079018|NCT02379273|141666044|SUPERIORITY|A Friedman repeated-measures ANOVA on ranks was applied to the unilateral AzBio data with follow-up pairwise comparisons based on the Tukey Test.|||||<|0.001||||||The threshold for statistical significance was p = 0.05.|ANOVA|||||||<0.001
70852760|NCT01578850|141194342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.005|TWO_SIDED|95.0|-0.9|-0.16|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 28||-0.16|-0.90|0.005
71068068|NCT03425396|141644612|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-13.5|||||TWO_SIDED|95.0|-32.4|5.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated|||5.9|-32.4|
71068069|NCT03425396|141644612|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-3.0|||||TWO_SIDED|95.0|-25.7|15.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated|||15.6|-25.7|
71068070|NCT03425396|141644612|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|10.0|||||TWO_SIDED|95.0|-40.4|28.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated|||28.9|-40.4|
71068071|NCT03425396|141644613|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-21.3|||||TWO_SIDED|95.0|-44.1|-1.0|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||-1.0|-44.1|
71068072|NCT03425396|141644613|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-13.9|||||TWO_SIDED|95.0|-32.2|4.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||4.9|-32.2|
71068073|NCT03425396|141644613|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-19.4|||||TWO_SIDED|95.0|-43.1|1.1|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||1.1|-43.1|
71068074|NCT03425396|141644613|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|6.7|||||TWO_SIDED|95.0|-43.8|23.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||23.2|-43.8|
71068075|NCT03425396|141644614|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-14.7|||||TWO_SIDED|95.0|-37.2|3.1|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||3.1|-37.2|
71068076|NCT03425396|141644614|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-15.9|||||TWO_SIDED|95.0|-34.3|1.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||1.2|-34.3|
71068077|NCT03425396|141644614|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-23.8|||||TWO_SIDED|95.0|-46.9|-4.3|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||-4.3|-46.9|
70941890|NCT01855997|141383972|SUPERIORITY_OR_OTHER|||||||9.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs2077415||||0.00000997
71068078|NCT03425396|141644614|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|3.4|||||TWO_SIDED|95.0|-48.5|19.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||19.7|-48.5|
71068079|NCT03425396|141644615|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-20.7|||||TWO_SIDED|95.0|-45.1|6.0|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||6.0|-45.1|
71068080|NCT03425396|141644615|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-17.8|||||TWO_SIDED|95.0|-40.2|5.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||5.9|-40.2|
71068081|NCT03425396|141644615|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-11.4|||||TWO_SIDED|95.0|-36.8|14.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.7|-36.8|
71068082|NCT03425396|141644615|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|3.3|||||TWO_SIDED|95.0|-47.0|33.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||33.2|-47.0|
71079019|NCT02379273|141666044|SUPERIORITY|A Friedman repeated-measures ANOVA on ranks was applied to the bilateral AzBio data with follow-up pairwise comparisons based on the Tukey Test.|||||<|0.001||||||The threshold for statistical significance was p = 0.05.|ANOVA|||||||<0.001
71079020|NCT02379273|141666045|SUPERIORITY|A one-way repeated-measures analysis of variance was applied to the data, with follow-up pairwise comparisons based on the Holm-Sidak method.|||||<|0.001||||||The threshold for statistical significance was p=0.05.|ANOVA|||||||<0.001
71079021|NCT02379273|141666046|SUPERIORITY|A one-way repeated-measures analysis of variance was applied to the data, with follow-up pairwise comparisons based on the Holm-Sidak method.|||||<|0.001|||||||ANOVA|The threshold for statistical significance was p=0.05.||||||<0.001
71079022|NCT02379273|141666047|SUPERIORITY|Pre- and postoperative mean scores were compared based on Friedman repeated-measures analysis of variance with follow-up pairwise comparisons based on the Tukey Test.|||||<|0.001||||||The threshold for statistical significance was p=0.05.|ANOVA|||||||<0.001
71079023|NCT00978341|141666048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.462||0.6797||95.0|-0.83|1.22|||ANOVA|||Difference from placebo (including Baseline), Day 1: 0.5 hours post-dose.||1.22|-0.83|0.6797
71079024|NCT00978341|141666048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.528||0.4811||95.0|-1.54|0.77|||ANOVA|||Difference from placebo (including Baseline), Day 1: 1 hour post-dose.||0.77|-1.54|0.4811
71079025|NCT00978341|141666048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.454||0.1693||95.0|-1.67|0.33|||ANOVA|||Difference from placebo (including Baseline), Day 1: 2 hours post-dose.||0.33|-1.67|0.1693
71068083|NCT03425396|141644616|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-13.6|||||TWO_SIDED|95.0|-40.4|13.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||13.2|-40.4|
71068084|NCT03425396|141644616|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-9.6|||||TWO_SIDED|95.0|-32.7|14.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.6|-32.7|
71068085|NCT03425396|141644616|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-11.9|||||TWO_SIDED|95.0|-38.2|14.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.9|-38.2|
71068086|NCT03425396|141644616|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|1.4|||||TWO_SIDED|95.0|-50.3|30.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||30.9|-50.3|
71068087|NCT03689374|141644639|NON_INFERIORITY|The responses were analyzed using an ANCOVA with treatment as fixed factor and baseline value as a covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomized treatment, using a regression model including randomized treatment group and data from baseline and all previous visits as covariates. The prespecified non inferiority margin was 0.3%-point.|Treatment difference|-0.29|||<|0.0001|TWO_SIDED|95.0|-0.38|-0.2|||t-distributed test|The non-inferiority p-value was calculated as two times the one-sided p-value from a t-distributed test.||||-0.20|-0.38|<0.0001
71068088|NCT05088603|141644665|SUPERIORITY|||||||0.106|||||||Fisher Exact|||||||0.106
71068089|NCT05088603|141644666|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
71068090|NCT05088603|141644667|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
71112586|NCT00654745|141732160|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.5|||<|0.0001|TWO_SIDED|95.0|-21.7|-17.4||last 2 hours mean SBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-17.4|-21.7|<0.0001
71112587|NCT00654745|141732161|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.3|||<|0.0001|TWO_SIDED|95.0|-12.0|-8.6||Change in mean seated systolic blood pressure from baseline to week 3.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-8.6|-12.0|<0.0001
70941891|NCT01855997|141383972|SUPERIORITY_OR_OTHER|||||||8.64e-06|TWO_SIDED||||||t-test, 2 sided|||rs9324018||||0.00000864
70941892|NCT01855997|141383973|SUPERIORITY_OR_OTHER|||||||3.68e-06|TWO_SIDED||||||t-test, 2 sided|||rs17037122||||0.00000368
70941893|NCT01855997|141383973|SUPERIORITY_OR_OTHER|||||||5.77e-06|TWO_SIDED||||||t-test, 2 sided|||rs715243||||0.00000577
70941894|NCT01855997|141383974|SUPERIORITY_OR_OTHER|||||||9.5e-06|TWO_SIDED||||||t-test, 2 sided|||rs2302503||||0.00000950
71068091|NCT05088603|141644669|SUPERIORITY|||||||0.529|||||||Fisher Exact|||||||0.529
71068092|NCT05088603|141644670|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
71068093|NCT05088603|141644671|SUPERIORITY|||||||0.502|||||||Fisher Exact|||||||0.502
71068094|NCT05088603|141644672|SUPERIORITY|||||||0.431|||||||Fisher Exact|||||||0.431
71068095|NCT05088603|141644673|SUPERIORITY|||||||0.434|||||||Fisher Exact|||||||0.434
71068096|NCT05088603|141644674|SUPERIORITY|||||||0.159|||||||Fisher Exact|||||||0.159
71068097|NCT05088603|141644675|SUPERIORITY|||||||0.051|||||||Fisher Exact|||||||0.051
71068098|NCT00594100|141644678|SUPERIORITY_OR_OTHER||Binomial Proportion|0.054|STANDARD_ERROR_OF_MEAN|0.016||0.002|TWO_SIDED|95.0|0.027|0.095|||One-Sample Binomial|Significance test was based on a one-sample binomial test|95% Confidence Interval is exact binomial using Clopper-Pearson method. Standard Error is from Normal approximation.|The EMPiRE Study tested the null hypothesis that the true MAE rate was greater than or equal to an Objective Performance Criterion (OPC) of 11.83% versus the alternative hypothesis that the true MAE rate was less than the OPC. The sample size was calculated based on 80% power and a Type I error rate of 0.025. The OPC was calculated from results of published carotid artery stenting studies that utilized distal embolic protection systems.||0.095|0.027|0.002
71068099|NCT02162719|141644708|SUPERIORITY||Hazard Ratio (Stratified Analysis)|0.6||||0.0372|TWO_SIDED|90.0|0.4|0.91||Stratification variables were adjuvant/neoadjuvant treatment including treatment with or without radiation, disease-free interval from last dose (\<=12 vs \>12 months vs. no prior chemotherapy), PTEN status of tumor (H-score 0, vs. 1 to 150, vs. \>150).|Log Rank|||||0.91|0.40|0.0372
71068100|NCT02162719|141644709|SUPERIORITY||Hazard Ratio (Stratified Analysis)|0.59||||0.1753|TWO_SIDED|90.0|0.3|1.16||Stratification variables were adjuvant/neoadjuvant treatment including treatment with or without radiation, disease-free interval from last dose (\<=12 vs \>12 months vs. no prior chemotherapy), PTEN status of tumor (H-score 0, vs. 1 to 150, vs. \>150).|Log Rank|||||1.16|0.30|0.1753
71068101|NCT02162719|141644710|SUPERIORITY||Hazard Ratio (Unstratified Analysis)|0.76||||0.3636|TWO_SIDED|90.0|0.46|1.27|||Log Rank|||||1.27|0.46|0.3636
71068102|NCT02162719|141644711|SUPERIORITY||Hazard Ratio (Stratified Analysis)|0.8||||0.3607|TWO_SIDED|95.0|0.5|1.28||Stratification variables were adjuvant/neoadjuvant treatment including treatment with/without radiation, disease-free interval from last dose (\<=12 vs \>12 months vs. no prior chemotherapy), PTEN status of tumor (H-score 0, vs. 1 to 150, vs. \>150).|Log Rank|||||1.28|0.50|0.3607
71068103|NCT02162719|141644712|SUPERIORITY||Hazard Ratio (Stratified Analysis)|0.73||||0.4422|TWO_SIDED|95.0|0.32|1.65||Stratification variables were adjuvant/neoadjuvant treatment including treatment with/without radiation, disease-free interval from last dose (\<=12 vs \>12 months vs. no prior chemotherapy), PTEN status of tumor (H-score 0, vs. 1 to 150, vs. \>150).|Log Rank|||||1.65|0.32|0.4422
71068104|NCT02162719|141644713|SUPERIORITY||Hazard Ratio (Unstratified Analysis)|1.13||||0.7599|TWO_SIDED|95.0|0.52|2.47|||Log Rank|||||2.47|0.52|0.7599
71068105|NCT01931475|141644738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-0.8|-0.2||||||||-0.2|-0.80|
70941895|NCT01855997|141383974|SUPERIORITY_OR_OTHER|||||||7.41e-06|TWO_SIDED||||||t-test, 2 sided|||rs6015181||||0.00000741
71068106|NCT01931475|141644739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-0.54|-0.19||||||||-0.19|-0.54|
71068107|NCT01931475|141644740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.49|||||TWO_SIDED|95.0|-5.62|-1.35|||||Total Score|||-1.35|-5.62|
71068108|NCT01931475|141644740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|||||TWO_SIDED|95.0|-1.21|-0.21|||||Pain|||-0.21|-1.21|
71068109|NCT01931475|141644740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.36|||||TWO_SIDED|95.0|-3.95|-0.78|||||Physical Function|||-0.78|-3.95|
71068110|NCT01931475|141644740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||||TWO_SIDED|95.0|-0.62|-0.16|||||Stiffness|||-0.16|-0.62|
71068111|NCT01931475|141644741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|||||TWO_SIDED|95.0|-0.41|-0.15||||||||-0.15|-0.41|
71068112|NCT01931475|141644742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|||||TWO_SIDED|95.0|-1.07|-0.34|||||BPI Severity of Worst Pain|||-0.34|-1.07|
71068113|NCT01931475|141644742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29|||||TWO_SIDED|95.0|-0.6|0.03|||||BPI Severity of Least Pain|||0.03|-0.60|
71068114|NCT01931475|141644742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||||TWO_SIDED|95.0|-0.82|-0.11|||||BPI Severity of Right Now Pain|||-0.11|-0.82|
71068115|NCT01931475|141644743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|||||TWO_SIDED|95.0|-0.53|-0.02|||||BPI Interference Average Score|||-0.02|-0.53|
71068116|NCT01931475|141644743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|||||TWO_SIDED|95.0|-0.94|-0.19|||||General activity|||-0.19|-0.94|
71068117|NCT01931475|141644743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||||TWO_SIDED|95.0|-0.74|-0.05|||||Mood|||-0.05|-0.74|
71068118|NCT01931475|141644743|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.47|||||TWO_SIDED|95.0|-0.82|-0.11|||||Walking ability|||-0.11|-0.82|
71068119|NCT01931475|141644743|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.31|||||TWO_SIDED|95.0|-0.68|0.06|||||Normal work (includes both work outside the home and housework)|||0.06|-0.68|
71068120|NCT01931475|141644743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|||||TWO_SIDED|95.0|-0.34|0.21|||||Relations with other people|||0.21|-0.34|
70941896|NCT01855997|141383975|SUPERIORITY_OR_OTHER|||||||8.05e-06|TWO_SIDED||||||t-test, 2 sided|||rs1550116||||0.00000805
70941897|NCT01855997|141383975|SUPERIORITY_OR_OTHER|||||||7.02e-06|TWO_SIDED||||||t-test, 2 sided|||rs1550115||||0.00000702
71068121|NCT01931475|141644743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|||||TWO_SIDED|95.0|-0.57|0.14|||||Sleep|||0.14|-0.57|
71068122|NCT01931475|141644743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|95.0|-0.4|0.27|||||Enjoyment of life|||0.27|-0.40|
71068123|NCT01931475|141644745|SUPERIORITY_OR_OTHER||Total Effect|97.49||||0.002|TWO_SIDED||||||Regression, Linear|||Path analysis for the direct analgesic effect was used to test the null hypothesis that the change in BPI average pain severity depends on the improvement of HADS-D or HADS-A, versus the alternative that the improvement in BPI average pain severity is due to a direct analgesic effect of the treatment and not dependent upon the improvement in depression and anxiety symptoms.||||0.002
71068124|NCT06175026|141644781|SUPERIORITY||Mean Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|0.062|<|0.001|TWO_SIDED|95.0|1.13|1.37||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||The null hypothesis was that the health messages would not elicit different levels of perceived message effectiveness compared to the neutral messages.||1.37|1.13|<0.001
71068125|NCT06175026|141644781|SUPERIORITY||Mean Difference (Final Values)|1.14|STANDARD_ERROR_OF_MEAN|0.062|<|0.001|TWO_SIDED|95.0|1.03|1.26||The p-value was not adjusted for multiple comparisons. The a prior threshold for statistical significance was 0.05.|Mixed Models Analysis|||The null hypothesis was that the environment messages would not elicit different perceived message effectiveness than the control messages.||1.26|1.03|<.001
71068126|NCT06175026|141644781|SUPERIORITY||Mean Difference (Final Values)|1.29|STANDARD_ERROR_OF_MEAN|0.062|<|0.001|TWO_SIDED|95.0|1.17|1.41||The p-value was not adjusted for multiple comparisons. The a prior threshold for statistical significance was 0.05.|Mixed Models Analysis|||The null hypothesis was that the health and environment messages would not elicit different perceived message effectiveness than the control messages.||1.41|1.17|<0.001
71068127|NCT06175026|141644781|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.062||0.1892|TWO_SIDED|95.0|-0.018|0.223||This p-value was adjusted for multiple comparisons (considering 3 tests among intervention arms) using the Bonferroni Holm method.|Mixed Models Analysis|||||.223|-0.018|.1892
71068128|NCT06175026|141644781|SUPERIORITY||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.62||0.47|TWO_SIDED|95.0|-0.17|0.08||This p-value was adjusted for multiple comparisons (considering 3 tests among intervention arms) using the Bonferroni Holm method.|Mixed Models Analysis|||||.08|-.17|.47
71079026|NCT00978341|141666048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.487||0.4034||95.0|-1.78|0.87|||ANOVA|||Difference from placebo (including Baseline) , Day 1: 3 hours post-dose.||0.87|-1.78|0.4034
71079027|NCT00978341|141666048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.694||0.1935||95.0|-2.36|0.5|||ANOVA|||Difference from placebo (including Baseline), Day 1: 4 hours post-dose.||0.50|-2.36|0.1935
71079028|NCT00978341|141666048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|0.715||0.0694||95.0|-2.83|0.12|||ANOVA|||Difference from placebo (including Baseline), Day 1: 5 hours post-dose.||0.12|-2.83|0.0694
71079029|NCT00978341|141666048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.55|STANDARD_ERROR_OF_MEAN|0.713||0.0396||95.0|-3.02|-0.08|||ANOVA|||Difference from placebo (including Baseline), Day 1: 6 hours post-dose.||-0.08|-3.02|0.0396
71079030|NCT00978341|141666048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.319||0.1531||95.0|-1.25|0.24|||ANOVA|||Difference from placebo (including Baseline), Day 1: 8 hours post-dose.||0.24|-1.25|0.1531
71079031|NCT00978341|141666048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.637||0.0951||95.0|-2.79|0.29|||ANOVA|||Difference from placebo (including Baseline), Day 1: 10 hours post-dose.||0.29|-2.79|0.0951
71079032|NCT00978341|141666048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|0.615||0.0614||95.0|-2.84|0.09|||ANOVA|||Difference from placebo (including Baseline), Day 1: 12 hours post-dose.||0.09|-2.84|0.0614
71068129|NCT06175026|141644781|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.062||0.051|TWO_SIDED|95.0|-0.27|-0.03||This p-value was adjusted for multiple comparisons (considering 3 tests among intervention arms) using the Bonferroni Holm method.|Mixed Models Analysis|||||-.03|-.27|.051
71068130|NCT04081610|141644785|NON_INFERIORITY|Compare the safety of the Lagricel® Ofteno multi-dose formulation against Lagricel® Ofteno unit doses manufactured by Sophia Laboratories S.A. of C.V. through the incidence of AD.|Median Difference (Final Values)|0.05||||0.409|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.409
71068131|NCT04081610|141644786|NON_INFERIORITY|Compare the tolerability of the Lagricel® Ofteno multi-dose formulation against Lagricel® Ofteno unit-dose manufactured by Sophia Laboratories S.A. of C.V. using the ICO score.||||||0.442|||||||Wilcoxon (Mann-Whitney)|||||||0.442
71068132|NCT04081610|141644786|EQUIVALENCE|F=2.606, 15.926||||||0.009|||||||Wilcoxon (Mann-Whitney)|||Final vs initial Eye Comfort Index||||0.009
71068133|NCT04081610|141644786|EQUIVALENCE|F=3.051, 19.336||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Final vs initial Eye Comfort Index||||0.002
71068134|NCT04081610|141644787|NON_INFERIORITY|Compare the safety of the Lagricel® Ofteno multi-dose formulation against Lagricel® Ofteno unit doses manufactured by Sophia Laboratories S.A. of C.V. through changes in BCVA.||||||0.904|||||||Wilcoxon (Mann-Whitney)|||||||0.904
71068135|NCT04081610|141644787|EQUIVALENCE|F=-1.414, 1.061||||||0.157|||||||Sign test|||Final vs initial VA||||0.157
71068136|NCT04081610|141644787|EQUIVALENCE|||||||1|||||||Sign test|||Final vs initial VA||||1.000
71068137|NCT04081610|141644788|NON_INFERIORITY|Compare the safety of the Lagricel® Ofteno multi-dose formulation against Lagricel® Ofteno unit doses manufactured by Sophia Laboratories S.A. of C.V. by changes in corneal and conjunctival staining with fluorescein.||||||1|||||||Fisher Exact|||||||1.000
71068138|NCT04081610|141644788|EQUIVALENCE|Chi-squared (2)= 6.400||||||0.041|||||||Chi-squared|||Final vs initial fluorescein staining||||0.041
71068139|NCT04081610|141644788|EQUIVALENCE|Chi-squared (2)=0.814||||||0.665|||||||Chi-squared|||||||0.665
71112588|NCT00654745|141732161|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.9|||<|0.0001|TWO_SIDED|95.0|-19.8|-16.1||Change in mean seated systolic blood pressure from baseline to week 6.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-16.1|-19.8|<0.0001
70941898|NCT01855997|141383975|SUPERIORITY_OR_OTHER|||||||7.02e-06|TWO_SIDED||||||t-test, 2 sided|||rs2082881||||0.00000702
70941899|NCT01855997|141383975|SUPERIORITY_OR_OTHER|||||||7.43e-06|TWO_SIDED||||||t-test, 2 sided|||exm2265462||||0.00000743
71068140|NCT04081610|141644789|NON_INFERIORITY|Compare the safety of the Lagricel® Ofteno multi-dose formulation against Lagricel® Ofteno unit doses manufactured by Sophia Laboratories S.A. of C.V. by changes of corneal and conjunctival staining with lysamine green.||||||0.713|||||||Fisher Exact|||||||0.713
71068141|NCT04081610|141644789|EQUIVALENCE|Chi-squared (3)=14.345||||||0.002|||||||Chi-squared|||Final vs initial lissamine green staining||||0.002
71068142|NCT04081610|141644789|EQUIVALENCE|Chi-squared (2)=0.506||||||0.777|||||||Chi-squared|||Final vs initial lissamine green staining||||0.777
71068143|NCT04081610|141644790|NON_INFERIORITY|Compare the safety of the Lagricel® Ofteno multi-dose formulation against Lagricel® Ofteno unit doses manufactured by Sophia Laboratories S.A. of C.V. by changes in conjunctival hyperemia.||||||1|||||||Chi-squared, Corrected|||||||1.000
71068144|NCT04081610|141644790|EQUIVALENCE|F=4.167, 1||||||0.031|||||||Fisher Exact|||Final vs initial conjunctival hyperemia||||0.031
71068145|NCT04081610|141644790|EQUIVALENCE|No significant change was observed.||||||1|||||||Chi-squared, Corrected|||Final vs initial conjunctival hyperemia||||1.000
71068146|NCT02225860|141644792|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||"The analysis of the primary and secondary outcome was based on an intention to treat principle. Copeptin was measured in each subject at baseline and week 2 and the change from baseline to end point (delta) was calculated for all subjects. The delta copeptin between subjects in the intervention and control arms was compared with a two sample t test for independent groups. One sample t-tests of the delta were used to examine whether there was any change over time for each group separately."||||<0.01
71068147|NCT02225860|141644793|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||"The analysis of the primary and secondary outcome was based on an intention to treat principle. Copeptin was measured in each subject at baseline and week 2 and the change from baseline to end point (delta) was calculated for all subjects. The delta copeptin between subjects in the intervention and control arms was compared with a two sample t test for independent groups. One sample t-tests of the delta were used to examine whether there was any change over time for each group separately."||||<0.01
71068148|NCT05338502|141644795|SUPERIORITY||Geometric Least Squares Mean (LSM) Ratio|0.9|||||TWO_SIDED|90.0|0.797|1.02|||ANOVA|||Fasted State||1.02|0.797|
71068149|NCT05338502|141644795|SUPERIORITY||Geometric LS Mean Ratio|0.99|||||TWO_SIDED|90.0|0.876|1.12|||ANOVA|||Fed state||1.12|0.876|
71068150|NCT05338502|141644796|SUPERIORITY||Geometric LS Mean Ratio|0.932|||||TWO_SIDED|90.0|0.829|1.05|||ANOVA|||Fasted state||1.05|0.829|
71068151|NCT05338502|141644796|SUPERIORITY||Geometric LS Mean Ratio|1.0|||||TWO_SIDED|90.0|0.888|1.13|||ANOVA|||Fed State||1.13|0.888|
71068152|NCT05338502|141644798|SUPERIORITY||Geometric LS Mean Ratio|0.818|||||TWO_SIDED|90.0|0.68|0.985|||ANOVA|||Fasted State||0.985|0.680|
71068153|NCT05338502|141644798|SUPERIORITY||Geometric LS Mean Ratio|0.782|||||TWO_SIDED|90.0|0.645|0.949|||ANOVA|||Fed state||0.949|0.645|
71068154|NCT01250873|141644815|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.17|||||TWO_SIDED|90.0|1.06|1.3|||ANOVA|||||1.30|1.06|
71068155|NCT01250873|141644816|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.14|||||TWO_SIDED|90.0|1.01|1.28|||ANOVA|||||1.28|1.01|
71068156|NCT01250873|141644817|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.8281|TWO_SIDED|90.0|-0.5|1.0|||Wilcoxon (Mann-Whitney)|||||1.00|-0.50|0.8281
70941900|NCT01855997|141383975|SUPERIORITY_OR_OTHER|||||||7.8e-07|TWO_SIDED||||||t-test, 2 sided|||rs6443144||||0.00000078
70941901|NCT01855997|141383975|SUPERIORITY_OR_OTHER|||||||8.94e-06|TWO_SIDED||||||t-test, 2 sided|||rs1403069||||0.00000894
70852761|NCT01578850|141194342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.001|TWO_SIDED|95.0|-1.18|-0.38|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 36||-0.38|-1.18|<0.001
70941902|NCT01855997|141383975|SUPERIORITY_OR_OTHER|||||||5.71e-06|TWO_SIDED||||||t-test, 2 sided|||rs9691873||||0.00000571
70941903|NCT01855997|141383975|SUPERIORITY_OR_OTHER|||||||7.29e-06|TWO_SIDED||||||t-test, 2 sided|||rs8012912||||0.00000729
71068157|NCT01250873|141644818|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.27|||||TWO_SIDED|90.0|1.17|1.39|||ANOVA|||||1.39|1.17|
71068158|NCT01250873|141644819|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.22|||||TWO_SIDED|90.0|1.1|1.36|||ANOVA|||||1.36|1.10|
71068159|NCT01250873|141644820|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.0||||0.3125|TWO_SIDED|90.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||||2.00|0.00|0.3125
71068160|NCT02278939|141644822|SUPERIORITY|||||||0.003||||||This was an intention to treat analysis using the Tukey-Kramer adjustment to account for unequal group sample sizes|ANOVA|||Hypothesis: the intervention group will have a significantly greater reduction in weight (kg) compared to the control from baseline to 3-months||||0.003
71068161|NCT02278939|141644823|SUPERIORITY|||||||0.001||||||This was an intention to treat analysis using the Tukey-Kramer adjustment to account for unequal group sample sizes|ANOVA|||Hypothesis: the intervention group will have a statistically greater reduction in percent weight compared to the control from baseline to 3-months||||.001
71068162|NCT02278939|141644824|SUPERIORITY|||||||0.002||||||This was an intention to treat analysis using the Tukey-Kramer adjustment to account for differences in group sample sizes|ANOVA|||Hypothesis: the intervention group will have a statistically greater reduction in BMI compared to the control from baseline to 3 months||||.002
71068163|NCT00930774|141644840|SUPERIORITY_OR_OTHER|||||||0.527|||||||ANOVA|df = 3,83; F=0.748||||||0.527
71068164|NCT00930774|141644841|SUPERIORITY_OR_OTHER|||||||0.835|||||||ANOVA|df = 3,83; F=0.286||||||0.835
71112589|NCT00654745|141732161|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.0|||<|0.0001|TWO_SIDED|95.0|-22.2|-17.8||Change in mean seated systolic blood pressure from baseline to week 9|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-17.8|-22.2|<0.0001
71112590|NCT00654745|141732161|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.7|||<|0.0001|TWO_SIDED|95.0|-25.7|-21.7||Change in mean seated systolic blood pressure from baseline to week 12|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-21.7|-25.7|<0.0001
71112591|NCT00654745|141732161|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.5|||<|0.0001|TWO_SIDED|95.0|-30.8|-26.2||Change in mean seated systolic blood pressure from baseline to week 15|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-26.2|-30.8|<0.0001
71112592|NCT00654745|141732161|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-31.1|||<|0.0001|TWO_SIDED|95.0|-33.3|-28.8||Change in mean seated systolic blood pressure from baseline to week 18|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-28.8|-33.3|<0.0001
71112593|NCT00654745|141732162|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1|||<|0.0001|TWO_SIDED|95.0|-5.1|-3.1||Change in mean seated diastolic blood pressure from baseline to week 3.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-3.1|-5.1|<0.0001
71112594|NCT00654745|141732162|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.2|||<|0.0001|TWO_SIDED|95.0|-9.4|-7.1||Change in mean seated diastolic blood pressure from baseline to week 6|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-7.1|-9.4|<0.0001
71112595|NCT00654745|141732162|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.7|||<|0.0001|TWO_SIDED|95.0|-10.9|-8.4||Change in mean seated diastolic blood pressure from baseline to week 9|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-8.4|-10.9|<0.0001
70941904|NCT01855997|141383975|SUPERIORITY_OR_OTHER|||||||8.28e-06|TWO_SIDED||||||t-test, 2 sided|||rs11158827||||0.00000828
71068165|NCT00930774|141644842|SUPERIORITY_OR_OTHER|||||||0.983|||||||ANOVA|df = 3,83; F=0.054||||||0.983
71068166|NCT00930774|141644843|SUPERIORITY_OR_OTHER|||||||0.554||||||df = 3,83; F=0.701|ANOVA|||||||0.554
71068167|NCT00930774|141644844|SUPERIORITY_OR_OTHER|||||||0.757||||||df = 3,83; F=0.395|ANOVA|||||||0.757
71068168|NCT00930774|141644845|SUPERIORITY_OR_OTHER|||||||0.302|||||||ANOVA|df = 3,83; F=1.236||||||0.302
71068169|NCT00930774|141644846|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|df = 3,83. F=6.343||||||0.001
71068170|NCT00930774|141644846|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71068171|NCT00930774|141644847|SUPERIORITY_OR_OTHER|||||||0.013|||||||ANOVA|df = 3,83; F=3.797||||||0.013
71068172|NCT00930774|141644847|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||||||0.05
71068173|NCT01680861|141644848|SUPERIORITY_OR_OTHER|||||||0.32|||||||Log Rank|||||||0.32
71068174|NCT01680861|141644849|SUPERIORITY_OR_OTHER|||||||0.99|||||||Log Rank|||||||0.99
71068175|NCT01680861|141644850|SUPERIORITY_OR_OTHER|||||||1|||||||Log Rank|||||||1.0
71068176|NCT01680861|141644851|SUPERIORITY_OR_OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.06
71068177|NCT01680861|141644852|SUPERIORITY_OR_OTHER|||||||0.18|||||||t-test, 2 sided|||||||0.18
71068178|NCT01680861|141644853|SUPERIORITY_OR_OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.65
71068179|NCT01598090|141644866|NON_INFERIORITY|Non-inferiority of Lambda/RBV/TVR to Alfa/RBV/TVR was not established because the lower limit of the 95% CI was less than the predefined non-inferiority margin of -12%. As a result, key secondary endpoints were not tested hierarchically to compare treatment groups.||||||0.0855||||||Non-inferiority testing is based on lower limit of confidence interval.|Mantel Haenszel|||||||0.0855
71068180|NCT00520533|141644926|SUPERIORITY|||||||0.194|||||||t-test, 2 sided|||Comparison of Biological T1/2 at Week 1 and Week 5.||||0.194
71068181|NCT00520533|141644927|SUPERIORITY|||||||0.172|||||||t-test, 2 sided|||Comparison of Effective T1/2 at Week 1 and Week 5.||||0.172
71068182|NCT02438826|141644936|SUPERIORITY||LSMean Difference|-0.8||||0.334|TWO_SIDED|95.0|-2.77|1.17||Cui, Hung, Wang (CHW) procedure applied|Mixed Models Analysis|||||1.17|-2.77|0.334
71068183|NCT02438826|141644937|SUPERIORITY||Odds Ratio (OR)|1.297||||0.17|TWO_SIDED|95.0|0.83|2.028||Cui, Hung, Wang (CHW) procedure applied|Mixed Models Analysis|||||2.028|0.830|0.170
71068184|NCT02438826|141644938|SUPERIORITY|||||||0.946||||||Chui, Hung, Wang (CHW) procedure applied)|Mixed Models Analysis|||||||0.946
71068185|NCT02438826|141644939|SUPERIORITY||Odds Ratio (OR)|1.51||||0.057|TWO_SIDED|95.0|0.987|2.309|||Mixed Models Analysis|||||2.309|0.987|0.057
71068186|NCT02438826|141644940|SUPERIORITY||Odds Ratio (OR)|1.141||||0.713|TWO_SIDED|95.0|0.563|2.314|||Mixed Models Analysis|||||2.314|0.563|0.713
70941905|NCT01855997|141383975|SUPERIORITY_OR_OTHER|||||||8.85e-06|TWO_SIDED||||||t-test, 2 sided|||rs11870323||||0.00000885
70941906|NCT01855997|141383975|SUPERIORITY_OR_OTHER|||||||7.17e-06|TWO_SIDED||||||t-test, 2 sided|||rs4821558||||0.00000717
71068187|NCT02438826|141644941|SUPERIORITY||Odds Ratio (OR)|1.008||||0.979|TWO_SIDED|95.0|0.548|1.856|||Mixed Models Analysis|||||1.856|0.548|0.979
71068188|NCT02438826|141644942|SUPERIORITY||Odds Ratio (OR)|0.788||||0.437|TWO_SIDED|95.0|0.431|1.44|||Mixed Models Analysis|||||1.440|0.431|0.437
71068189|NCT02397122|141644950|SUPERIORITY|||||||0.259|||||||Mann-Whitney|||Baseline||||0.259
71068190|NCT02397122|141644950|SUPERIORITY|||||||0.097|||||||Mann-Whitney|||6 weeks||||0.097
71068191|NCT02397122|141644950|SUPERIORITY|||||||0.07||||||\<0.05|Mann-Whitney U|||6 months||||0.070
71068192|NCT02397122|141644951|SUPERIORITY|||||||0.067|||||||Mann-Whitney|||Baseline||||0.067
71068193|NCT02397122|141644951|SUPERIORITY|||||||0.13|||||||Mann-Whitney|||6 weeks||||0.130
71068194|NCT02397122|141644951|SUPERIORITY|||||||0.128||||||\<0.05|Mann-Whitney U|||6 months||||0.128
70941907|NCT01855997|141383976|SUPERIORITY_OR_OTHER|||||||6.29e-06|TWO_SIDED||||||t-test, 2 sided|||rs6443144||||0.00000629
70941908|NCT01855997|141383976|SUPERIORITY_OR_OTHER|||||||5.79e-06|TWO_SIDED||||||t-test, 2 sided|||rs1692421||||0.00000579
70941909|NCT01855997|141383976|SUPERIORITY_OR_OTHER|||||||5.53e-06|TWO_SIDED||||||t-test, 2 sided|||rs1692423||||0.00000553
71068195|NCT02397122|141644952|SUPERIORITY|||||||0.298|||||||Mann-Whitney|||Baseline||||0.298
71068196|NCT02397122|141644952|SUPERIORITY|||||||0.152|||||||Mann-Whitney|||6 weeks||||0.152
71068197|NCT02397122|141644952|SUPERIORITY|||||||0.317||||||\<0.05|Mann-Whitney U|||6 months||||0.317
71068198|NCT02397122|141644953|SUPERIORITY|||||||0.136|||||||Mann-Whitney|||Baseline||||0.136
71068199|NCT02397122|141644953|SUPERIORITY|||||||0.041|||||||Mann-Whitney|||6 weeks||||0.041
71068200|NCT02397122|141644953|SUPERIORITY|||||||0.064||||||\<0.05|Mann-Whitney U|||6 months||||0.064
71068201|NCT02397122|141644954|SUPERIORITY|||||||0.245|||||||Mann-Whitney|||Baseline||||0.245
71068202|NCT02397122|141644954|SUPERIORITY|||||||0.099|||||||Mann-Whitney|||6 weeks||||0.099
71068203|NCT02397122|141644954|SUPERIORITY|||||||0.077|||||||Mann-Whitney U|||||||0.077
71068204|NCT02397122|141644955|SUPERIORITY|||||||0.946|||||||Mann-Whitney|||Baseline||||0.946
71068205|NCT02397122|141644955|SUPERIORITY|||||||0.001|||||||Mann-Whitney|||6 weeks||||0.001
71068206|NCT02397122|141644955|SUPERIORITY|||||||0.001||||||\<0.05|Mann-Whitney U|||6 months||||0.001
71068207|NCT02703467|141645007|SUPERIORITY||||||>|0.05||||||calculated|t-test, 2 sided|||||||>0.05
71068208|NCT00877487|141645049|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.23|||<|0.0001|TWO_SIDED|95.0|-19.1|-11.4|||ANCOVA|||||-11.4|-19.1|<0.0001
71068209|NCT00877487|141645050|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
71068210|NCT00877487|141645051|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
71068211|NCT04740827|141645061|SUPERIORITY||Least Squares Mean Difference|-2.43|STANDARD_ERROR_OF_MEAN|0.426|<|0.0001|TWO_SIDED|95.0|-3.27|-1.59|||MMRM||MMRM=baseline monthly migraine days as covariate, treatment group, visit, region and number of classes of failed prior treatments as fixed factors; treatment group and baseline-by-visit as interaction terms, with an unstructured covariance matrix.|||-1.59|-3.27|<0.0001
71068212|NCT04740827|141645062|SUPERIORITY||Least Squares Mean Difference|-2.35|STANDARD_ERROR_OF_MEAN|0.425|<|0.0001|TWO_SIDED|95.0|-3.19|-1.52|||MMRM||MMRM=baseline monthly migraine days as covariate, treatment group, visit, region and number of classes of failed prior treatments as fixed factors; treatment group and baseline-by-visit as interaction terms, with an unstructured covariance matrix.|||-1.52|-3.19|<0.0001
71068213|NCT04740827|141645063|SUPERIORITY||Odds Ratio (OR)|5.15|||<|0.0001|TWO_SIDED|95.0|3.02|8.79|||Regression, Logistic||Odds ratio and p-value are based on logistic regression with treatment group, region, baseline monthly migraine days, and number of classes of failed prior prophylactic treatments (2 and \>2) as explanatory variables.|||8.79|3.02|<0.0001
71068214|NCT04740827|141645064|SUPERIORITY||Odds Ratio (OR)|4.82|||<|0.0001|TWO_SIDED|95.0|2.85|8.14|||Regression, Logistic||Odds ratio and p-value are based on logistic regression with treatment group, region, baseline monthly migraine days, and number of classes of failed prior prophylactic treatments (2 and \>2) as explanatory variables.|||8.14|2.85|<0.0001
71068215|NCT04740827|141645065|SUPERIORITY||Least Squares Mean Difference|-2.28|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|-3.15|-1.42|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||-1.42|-3.15|<0.0001
71068216|NCT04740827|141645066|SUPERIORITY||Least Squares Mean Difference|-2.19|STANDARD_ERROR_OF_MEAN|0.439|<|0.0001|TWO_SIDED|95.0|-3.05|-1.32|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||-1.32|-3.05|<0.0001
71068217|NCT04740827|141645067|SUPERIORITY||Least Squares Mean Difference|-2.68|STANDARD_ERROR_OF_MEAN|0.381|<|0.0001|TWO_SIDED|95.0|-3.43|-1.93|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||-1.93|-3.43|<0.0001
71068218|NCT04740827|141645068|SUPERIORITY||Least Squares Mean Difference|-2.61|STANDARD_ERROR_OF_MEAN|0.38|<|0.0001|TWO_SIDED|95.0|-3.36|-1.86|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||-1.86|-3.36|<0.0001
71068219|NCT04740827|141645069|SUPERIORITY||Least Squares Mean Difference|17.67|STANDARD_ERROR_OF_MEAN|2.348|<|0.0001|TWO_SIDED|95.0|13.05|22.3|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||22.30|13.05|<0.0001
71068220|NCT04740827|141645070|SUPERIORITY||Least Squares Mean Difference|17.88|STANDARD_ERROR_OF_MEAN|2.308|<|0.0001|TWO_SIDED|95.0|13.34|22.42|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||22.42|13.34|<0.0001
71068221|NCT04740827|141645071|SUPERIORITY||Least Squares Mean Difference|-4.71|STANDARD_ERROR_OF_MEAN|0.844|<|0.0001|TWO_SIDED|95.0|-6.37|-3.05|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||-3.05|-6.37|<0.0001
71068222|NCT04740827|141645072|SUPERIORITY||Least Squares Mean Difference|-4.39|STANDARD_ERROR_OF_MEAN|0.786|<|0.0001|TWO_SIDED|95.0|-5.94|-2.85|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||-2.85|-5.94|<0.0001
71068223|NCT04740827|141645073|SUPERIORITY||Least Squares Mean Difference|-6.42|STANDARD_ERROR_OF_MEAN|0.912|<|0.0001|TWO_SIDED|95.0|-8.22|-4.63|||MMRM||MMRM=baseline monthly migraine days as covariate, treatment group, visit, region and number of classes of failed prior treatments as fixed factors; treatment group and baseline-by-visit as interaction terms, with an unstructured covariance matrix.|||-4.63|-8.22|<0.0001
71068224|NCT02060058|141645075|OTHER|The evaluation of SVR rate was based on full-analysis-set (FAS) and modified intention-to-treat population (mITT). FAS population included subjects receiving ≥ 1 dose of any antiviral agents (boceprevir and/or PEG-IFN, and/or RBV). MITT population included subjects receiving ≥ 1 dose of boceprevir.||||||0.01|||||||Chi-squared|||||||0.01
71068225|NCT01435018|141645080|NON_INFERIORITY|"Non-inferiority is defined as demonstrating that the 48-week PFS rate in ET+ART is within 15 percent of PTX+ART. The selection of the 15 percent non-inferiority margin was a combination of clinical judgment and statistical reasoning. A poll of the sites was conducted to derive the maximum treatment difference that is considered clinically relevant (i.e. largest acceptable difference in order to gain the advantages (e.g. cost) of the experimental chemotherapy)."|Cumulative rate difference|-30.3|||||TWO_SIDED|95.0|-52.3|-8.3|||||Confidence interval (CI) estimation was stratified by screening CD4 count using Greenwood's variance with the inverse of this variance used for the stratum weights. CI stratified by country was not performed due to small number of observations.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 PFS rate with 95% two-sided confidence interval.||-8.3|-52.3|
70941910|NCT01855997|141383976|SUPERIORITY_OR_OTHER|||||||9.46e-06|TWO_SIDED||||||t-test, 2 sided|||rs9691873||||0.00000946
71068226|NCT01435018|141645081|NON_INFERIORITY|"Non-inferiority is defined as demonstrating that the 48-week PFS rate in BV+ART is within 15 percent of PTX+ART. The selection of the 15 percent non-inferiority margin was a combination of clinical judgment and statistical reasoning. A poll of the sites was conducted to derive the maximum treatment difference that is considered clinically irrelevant (i.e. largest acceptable difference in order to gain the advantages (e.g. cost) of the experimental chemotherapy)."|Cumulative rate difference|-19.8|||||TWO_SIDED|95.0|-32.3|-7.4|||||Confidence interval estimation was stratified by screening CD4 count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 PFS rate with 95% two-sided confidence interval.||-7.4|-32.3|
71068227|NCT01435018|141645081|NON_INFERIORITY|"Non-inferiority is defined as demonstrating that the 48-week PFS rate in BV+ART is within 15 percent of PTX+ART. The selection of the 15 percent non-inferiority margin was a combination of clinical judgment and statistical reasoning. A poll of the sites was conducted to derive the maximum treatment difference that is considered clinically irrelevant (i.e. largest acceptable difference in order to gain the advantages (e.g. cost) of the experimental chemotherapy)."|Cumulative rate difference|-20.1|||||TWO_SIDED|95.0|-32.2|-7.9|||||Confidence interval estimation was stratified by country using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative PFS rate with 95% two-sided confidence interval.||-7.9|-32.2|
71079033|NCT00978341|141666048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.619||0.1946||95.0|-2.29|0.54|||ANOVA|||Difference from placebo (including Baseline), Day 8: pre-dose.||0.54|-2.29|0.1946
71068228|NCT01435018|141645082|OTHER||Cumulative rate difference|14.7|||||TWO_SIDED|95.0|-1.9|31.4|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of death with 95% two-sided confidence interval.||31.4|-1.9|
71068229|NCT01435018|141645083|OTHER||Cumulative rate difference|8.4|||||TWO_SIDED|95.0|-0.4|17.2|||||Confidence interval estimation was stratified by screening CD4 count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of death with 95% two-sided confidence interval.||17.2|-0.4|
71068230|NCT01435018|141645085|OTHER||Cumulative rate difference|16.3|||||TWO_SIDED|95.0|3.7|28.8||||||Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of IERC-confirmed KS progression with 95% two-sided confidence interval.|Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|28.8|3.7|
71068231|NCT01435018|141645086|OTHER||Cumulative rate difference|-15.0|||||TWO_SIDED|95.0|-34.4|4.3|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of AIDS-defining events with 95% two-sided confidence interval.||4.3|-34.4|
71068232|NCT01435018|141645087|OTHER||Cumulative rate difference|-3.3|||||TWO_SIDED|95.0|-13.3|6.6|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of AIDS-defining events with 95% two-sided confidence interval.||6.6|-13.3|
71068233|NCT01435018|141645088|OTHER||Cumulative rate difference|4.3|||||TWO_SIDED|95.0|-1.9|10.6|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of HIV-1 RNA virologic failure with 95% two-sided confidence interval.||10.6|-1.9|
71068234|NCT01435018|141645089|OTHER||Cumulative rate difference|5.5|||||TWO_SIDED|95.0|-0.1|11.0|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of HIV-1 RNA virologic failure with 95% two-sided confidence interval.||11.0|-0.1|
71068235|NCT01435018|141645092|OTHER||Cumulative rate difference|19.4|||||TWO_SIDED|95.0|-4.1|43.0|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, or AIDS defining event.||43.0|-4.1|
71068236|NCT01435018|141645093|OTHER||Cumulative rate difference|14.4|||||TWO_SIDED|95.0|1.8|27.0|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, or AIDS defining event.||27.0|1.8|
71068237|NCT01435018|141645094|OTHER||Cumulative rate difference|24.2|||||TWO_SIDED|95.0|0.9|47.4|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, AIDS defining event, or virologic failure.||47.4|0.9|
71112596|NCT00654745|141732162|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.2|||<|0.0001|TWO_SIDED|95.0|-12.5|-9.9||Change in mean seated diastolic blood pressure from baseline to week 12|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-9.9|-12.5|<0.0001
71112597|NCT00654745|141732162|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.4|||<|0.0001|TWO_SIDED|95.0|-15.7|-13.1||Change in mean seated diastolic blood pressure from baseline to week 15|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-13.1|-15.7|<0.0001
70941911|NCT01855997|141383976|SUPERIORITY_OR_OTHER|||||||4.5e-06|TWO_SIDED||||||t-test, 2 sided|||rs7968170||||0.00000450
71068238|NCT01435018|141645095|OTHER||Cumulative rate difference|18.8|||||TWO_SIDED|95.0|6.3|31.3|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, AIDS defining event, or virologic failure.||31.3|6.3|
70852762|NCT01578850|141194342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|||<|0.001|TWO_SIDED|95.0|-1.35|-0.54|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 44||-0.54|-1.35|<0.001
70941912|NCT01855997|141383977|SUPERIORITY_OR_OTHER|||||||1.18e-06|TWO_SIDED||||||t-test, 2 sided|||rs9287655||||0.00000118
70941913|NCT01855997|141383977|SUPERIORITY_OR_OTHER|||||||5.31e-06|TWO_SIDED||||||t-test, 2 sided|||rs216312||||0.00000531
70941914|NCT01855997|141383978|SUPERIORITY_OR_OTHER|||||||5.93e-06|TWO_SIDED||||||t-test, 2 sided|||rs993147||||0.00000593
70941915|NCT01855997|141383978|SUPERIORITY_OR_OTHER|||||||9.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs10978436||||0.00000997
71068239|NCT01435018|141645096|OTHER||Cumulative rate difference|24.2|||||TWO_SIDED|95.0|0.9|47.4|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, AIDS defining event, virologic failure, or KS-IRIS.||47.4|0.9|
71068240|NCT01435018|141645097|OTHER||Cumulative rate difference|17.7|||||TWO_SIDED|95.0|6.2|29.3|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, AIDS defining event, virologic failure, or KS-IRIS.||29.3|6.2|
71068241|NCT01435018|141645098|OTHER||Cumulative rate difference|37.5|||||TWO_SIDED|95.0|13.6|61.4|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of change in KS treatment.||61.4|13.6|
71068242|NCT01435018|141645099|OTHER||Cumulative rate difference|11.1|||||TWO_SIDED|95.0|-0.4|22.7|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of change in KS treatment.||22.7|-0.4|
71068243|NCT01435018|141645100|OTHER||Cumulative rate difference|14.7|||||TWO_SIDED|95.0|-1.9|31.4|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the cumulative rate of death with 95% two-sided confidence interval.||31.4|-1.9|
71068244|NCT01435018|141645101|OTHER||Cumulative rate difference|8.4|||||TWO_SIDED|95.0|-0.4|17.2|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the cumulative rate of death with 95% two-sided confidence interval.||17.2|-0.4|
71068245|NCT01435018|141645102|OTHER||Hazard Ratio (HR)|1.9|||||TWO_SIDED|95.0|1.1|3.4|||||Hazard ratio for ET+ART relative to PTX+ART adjusted for screening CD4 lymphocyte count.|||3.4|1.1|
71068246|NCT01435018|141645103|OTHER||Hazard Ratio (HR)|1.5|||||TWO_SIDED|95.0|1.1|2.2|||||Hazard ratio for BV+ART relative to PTX+ART adjusted for screening CD4 lymphocyte count.|||2.2|1.1|
71068247|NCT01435018|141645104|OTHER||Odds Ratio (OR)|0.3|||||TWO_SIDED|95.0|0.1|0.7|||||Odds ratio for ET+ART relative to PTX+ART adjusted for screening CD4 lymphocyte count.|||0.7|0.1|
71068248|NCT01435018|141645105|OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.5|1.3|||||Odds ratio for BV+ART relative to PTX+ART adjusted for screening CD4 lymphocyte count and country.|||1.3|0.5|
71068249|NCT03806933|141645132|OTHER||Hazard Ratio (HR)|1.03|||=|0.881|TWO_SIDED|95.0|0.7|1.51||P-values were based on Wald Chi-Square tests for hazard ratios.|Wald Chi-square test||Hazard ratio (HR) was estimated using a Cox proportional hazards regression model. 95% CIs were calculated based on individual Wald tests.|||1.51|0.7|= 0.881
71112598|NCT00654745|141732162|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.1|||<|0.0001|TWO_SIDED|95.0|-16.5|-13.6||Change in mean seated diastolic blood pressure from baseline to week 18|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-13.6|-16.5|<0.0001
71068250|NCT03806933|141645132|OTHER||Hazard Ratio (HR)|0.72|||=|0.089|TWO_SIDED|95.0|0.49|1.05||P-values were based on Wald Chi-Square tests for hazard ratios.|Wald Chi-square test||HR was estimated using a Cox proportional hazards regression model. 95% CIs were calculated based on individual Wald tests.|||1.05|0.49|= 0.089
71068251|NCT03806933|141645132|OTHER||Hazard Ratio (HR)|0.56||||0.0035|TWO_SIDED|95.0|0.38|0.83|||Wald Chi-square test|P-values were based on Wald Chi-Square tests for hazard ratios.|HR was estimated using a Cox proportional hazards regression model. 95% CIs were calculated based on individual Wald tests.|||0.83|0.38|0.0035
71068252|NCT02282631|141645161|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|"U=390.5 Z=-2.3 p=0.02~The mean and SD values are provided for descriptive purposes only."||||||0.02
71068253|NCT02282631|141645162|SUPERIORITY_OR_OTHER|||||||0.02||||||"U=665.5 Z=-2.3 p=0.02~The mean and SD values are provided for descriptive purposes only."|Wilcoxon (Mann-Whitney)|||||||0.02
71068254|NCT02282631|141645163|SUPERIORITY_OR_OTHER|||||||0.02||||||"U=596.5 Z=-2.4 p=0.02~The mean and SD values are provided for descriptive purposes only."|Wilcoxon (Mann-Whitney)|||||||0.02
71068255|NCT02282631|141645164|SUPERIORITY_OR_OTHER|||||||0.01||||||"U=955.0 Z=-2.5 p=0.01~The mean and SD values are provided for descriptive purposes only."|Wilcoxon (Mann-Whitney)|||||||0.01
71068256|NCT01058993|141645172|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|Student t-test-comparison means of normal subjects \& controls.||||||<0.05
71112599|NCT00383331|141732192|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Fisher Exact|||The response rates are separately evaluated for these two treatment arms. For each arm, a sample size of 48 achieves 91% power to detect a difference of 20% between the null hypothesis of 15% response rate and the alternative hypothesis of 35% using a one-sided, binomial hypothesis test with a target significance level of 2.5% (the actual significance level is 2.2%).||||0.48
71112600|NCT00383331|141732197|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Log Rank|||||||0.56
70941916|NCT01855997|141383978|SUPERIORITY_OR_OTHER|||||||5.81e-06|TWO_SIDED||||||t-test, 2 sided|||rs2370220||||0.00000581
71068257|NCT01058993|141645172|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Ratio paired t-test|Ratio paired t-test for comparison of baselines and responses for each category of leukocytes||The patients' leukocyte counts before and after plerixafor were compared.||||<0.05
71068258|NCT03214380|141645215|NON_INFERIORITY|Non-inferiority Margin = 0.4 for HbA1c|Least Square Mean Difference (LSMean)|0.06|||||TWO_SIDED|95.0|-0.05|0.16||||||||0.16|-0.05|
71068259|NCT03214380|141645216|SUPERIORITY||Mean Difference (Net)|-11.8|||<|0.001|TWO_SIDED|95.0|-18.1|-5.5|||ANCOVA|||||-5.5|-18.1|<0.001
71068260|NCT03214380|141645217|SUPERIORITY||Mean Difference (Net)|-17.4|||<|0.001|TWO_SIDED|95.0|-25.3|-9.5|||ANCOVA|||||-9.5|-25.3|<0.001
71068261|NCT00394836|141645230|SUPERIORITY_OR_OTHER||percentage of responders|13.0|||||TWO_SIDED|95.0|4.0|31.0|||||Response rate is calculated as the number of responses divided by the number of participants treated \* 100.|||31|4|
71068262|NCT00394836|141645230|SUPERIORITY_OR_OTHER||percentage of responders|10.0|||||TWO_SIDED|95.0|5.0|19.0||||||||19|5|
71068263|NCT04932655|141645307|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|103.22|||||TWO_SIDED|90.0|96.88|109.98||||||||109.98|96.88|
71068264|NCT04932655|141645307|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|109.64|||||TWO_SIDED|90.0|102.9|116.82||||||||116.82|102.9|
71068265|NCT04932655|141645307|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|102.9|||||TWO_SIDED|90.0|96.57|109.64||||||||109.64|96.57|
71068266|NCT04932655|141645308|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|98.47|||||TWO_SIDED|90.0|96.33|100.65||||||||100.65|96.33|
71068267|NCT04932655|141645308|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|98.88|||||TWO_SIDED|90.0|96.74|101.07||||||||101.07|96.74|
71068268|NCT04932655|141645308|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|100.32|||||TWO_SIDED|90.0|98.15|102.54||||||||102.54|98.15|
71068269|NCT04932655|141645309|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|98.5|||||TWO_SIDED|90.0|96.33|100.71||||||||100.71|96.33|
71068270|NCT04932655|141645309|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|99.03|||||TWO_SIDED|90.0|96.85|101.26||||||||101.26|96.85|
71068271|NCT04932655|141645309|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|100.25|||||TWO_SIDED|90.0|98.05|102.5||||||||102.50|98.05|
71068272|NCT01665157|141645310|SUPERIORITY_OR_OTHER|||||||0.435||||||Not significant|ANOVA|||||||0.435
71068273|NCT01665157|141645311|SUPERIORITY_OR_OTHER|||||||0.046|||||||Chi-squared|||||||0.046
71068274|NCT01665157|141645311|SUPERIORITY_OR_OTHER|||||||0.024|||||||Chi-squared|||"Null hypothesis: Low-residue diet package and 2L PEG vs. Self-controlled diet and 2L PEG provides same preparation quality."||||0.024
71068275|NCT01665157|141645311|SUPERIORITY_OR_OTHER|||||||0.041|||||||Chi-squared|||||||0.041
71068276|NCT01665157|141645314|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Chi-squared|||||||<0.01
71068277|NCT01665157|141645315|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Chi-squared|||||||<0.01
71068278|NCT01665157|141645316|SUPERIORITY_OR_OTHER|||||||0.025|||||||Chi-squared|||||||0.025
71068279|NCT02780713|141645325|SUPERIORITY||Percentage|17.02|||||TWO_SIDED|95.0|11.79|24.58||||||||24.58|11.79|
71068280|NCT02780713|141645325|SUPERIORITY||Percentage|36.28|||||TWO_SIDED|95.0|23.84|55.2||||||||55.20|23.84|
71068281|NCT02780713|141645325|SUPERIORITY||Percentage|24.1|||||TWO_SIDED|95.0|16.84|34.48||||||||34.48|16.84|
71068282|NCT02780713|141645326|SUPERIORITY||Percentage|31.75|||||TWO_SIDED|95.0|25.77|39.12||||||||39.12|25.77|
71068283|NCT02780713|141645326|SUPERIORITY||Percentage|54.17|||||TWO_SIDED|95.0|42.16|69.6||||||||69.60|42.16|
71068284|NCT02780713|141645326|SUPERIORITY||Pecentage|41.23|||||TWO_SIDED|95.0|34.79|48.86||||||||48.86|34.79|
71068285|NCT02111577|141645338|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and Eastern Cooperative Oncology Group (ECOG) score (0, 1 vs 2)|Hazard Ratio (HR)|1.042||||0.596|TWO_SIDED|95.0|0.895|1.213|||Log Rank|||Stratified||1.213|0.895|0.596
71068286|NCT02111577|141645338|SUPERIORITY||Hazard Ratio (HR)|1.036||||0.648|TWO_SIDED|95.0|0.891|1.204|||Log Rank|||Unstratified||1.204|0.891|0.648
71068287|NCT02111577|141645339|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.908||||0.335|TWO_SIDED|95.0|0.746|1.105|||Log Rank|||Stratified||1.105|0.746|0.335
71068288|NCT02111577|141645339|SUPERIORITY||Hazard Ratio (HR)|0.879||||0.192|TWO_SIDED|95.0|0.725|1.067|||Log Rank|||Unstratified||1.067|0.725|0.192
71068289|NCT02111577|141645340|SUPERIORITY|Stratified by region (US vs other), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|1.312||||0.071|TWO_SIDED|95.0|0.976|1.762|||Log Rank|||Stratified||1.762|0.976|0.071
71068290|NCT02111577|141645340|SUPERIORITY||Hazard Ratio (HR)|1.283||||0.09|TWO_SIDED|95.0|0.961|1.712|||Log Rank|||Unstratified||1.712|0.961|0.09
71068291|NCT02111577|141645341|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|1.461||||0.049|TWO_SIDED|95.0|1.0|2.134|||Log Rank|||Stratified||2.134|1|0.049
71068292|NCT02111577|141645341|SUPERIORITY||Hazard Ratio (HR)|1.436||||0.053|TWO_SIDED|95.0|0.993|2.077|||Log Rank|||Unstratified||2.077|0.993|0.053
71068293|NCT02111577|141645342|SUPERIORITY|Stratified by region (US vs other) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.938||||0.501|TWO_SIDED|95.0|0.779|1.13|||Log Rank|||Stratified||1.13|0.779|0.501
71068294|NCT02111577|141645342|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.512|TWO_SIDED|95.0|0.781|1.131|||Log Rank|||Unstratified||1.131|0.781|0.512
71068295|NCT02111577|141645343|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.99||||0.886|TWO_SIDED|95.0|0.863|1.136|||Log Rank|||Stratified||1.136|0.863|0.886
71068296|NCT02111577|141645343|SUPERIORITY||Hazard Ratio (HR)|1.001||||0.992|TWO_SIDED|95.0|0.875|1.145|||Log Rank|||Unstratified||1.145|0.875|0.992
71068297|NCT02111577|141645344|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|1.001||||0.994|TWO_SIDED|95.0|0.847|1.184|||Log Rank|||Stratified||1.184|0.847|0.994
71068298|NCT02111577|141645344|SUPERIORITY||Hazard Ratio (HR)|1.002||||0.982|TWO_SIDED|95.0|0.851|1.18|||Log Rank|||Unstratified||1.18|0.851|0.982
71068299|NCT02111577|141645345|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|1.077||||0.392|TWO_SIDED|95.0|0.909|1.277|||Log Rank|||Stratified||1.277|0.909|0.392
71068300|NCT02111577|141645345|SUPERIORITY||Hazard Ratio (HR)|1.068||||0.439|TWO_SIDED|95.0|0.905|1.262|||Log Rank|||Unstratified||1.262|0.905|0.439
71068301|NCT02111577|141645346|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|1.03||||0.754|TWO_SIDED|95.0|0.857|1.238|||Log Rank|||Stratified||1.238|0.857|0.754
71068302|NCT02111577|141645346|SUPERIORITY||Hazard Ratio (HR)|1.009||||0.924|TWO_SIDED|95.0|0.844|1.207|||Log Rank|||Unstratified||1.207|0.844|0.924
71068303|NCT02111577|141645347|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.918||||0.732|TWO_SIDED|95.0|0.563|1.497|||Log Rank|||Stratified||1.497|0.563|0.732
71068304|NCT02111577|141645347|SUPERIORITY||Hazard Ratio (HR)|0.913||||0.713|TWO_SIDED|95.0|0.561|1.485|||Log Rank|||Unstratified||1.485|0.561|0.713
71068305|NCT02111577|141645348|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.891||||0.694|TWO_SIDED|95.0|0.5|1.587|||Log Rank|||Stratified||1.587|0.5|0.694
71068306|NCT02111577|141645348|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.661|TWO_SIDED|95.0|0.496|1.562|||Log Rank|||Unstratified||1.562|0.496|0.661
71068307|NCT02111577|141645349|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.895||||0.111|TWO_SIDED|95.0|0.781|1.027|||Log Rank|||Stratified||1.027|0.781|0.111
71068308|NCT02111577|141645349|SUPERIORITY||Hazard Ratio (HR)|0.913||||0.184|TWO_SIDED|95.0|0.798|1.044|||Log Rank|||Unstratified||1.044|0.798|0.184
71068309|NCT02111577|141645350|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.939||||0.46|TWO_SIDED|95.0|0.795|1.11|||Log Rank|||Stratified||1.11|0.795|0.46
71068310|NCT02111577|141645350|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.534|TWO_SIDED|95.0|0.807|1.118|||Log Rank|||Unstratified||1.118|0.807|0.534
71112601|NCT00924612|141732198|OTHER||Odds Ratio, log|130.83|STANDARD_ERROR_OF_MEAN|0.0844||0.0025|TWO_SIDED|90.0|113.59|150.7|||t-test, 2 sided|||Comparison of diets based on full crossover model|ANOVA of a multicenter, 4 sequence, 5 treatment crossover model using ln-transformed data. Normal fat diet compared to fasting, very low fat, low fat, and high fat diets as part of the overall analysis. No adjustments for multiplicity made.|150.70|113.59|0.0025
71112602|NCT00924612|141732198|OTHER||Odds Ratio, log|101.84|STANDARD_ERROR_OF_MEAN|0.0954||0.8494|TWO_SIDED|90.0|86.8|119.47|||t-test, 2 sided|||Comparison of diets based on full crossover model||119.47|86.80|0.8494
71112603|NCT00924612|141732198|OTHER||Odds Ratio, log|73.55|STANDARD_ERROR_OF_MEAN|0.0902||0.0013|TWO_SIDED|90.0|63.23|85.55|||t-test, 2 sided|||Comparison of diets based on full crossover model||85.55|63.23|0.0013
71112604|NCT00924612|141732198|OTHER||Odds Ratio, log|62.62|STANDARD_ERROR_OF_MEAN|0.0954|<|0.0001|TWO_SIDED|90.0|53.38|76.46|||t-test, 2 sided|||Comparison of diets based on full crossover model||76.46|53.38|<0.0001
71112605|NCT04852055|141732202|SUPERIORITY||average marginal effect|-2.8|||||TWO_SIDED|95.0|-6.1|0.5||||||||0.5|-6.1|
71112606|NCT04852055|141732203|SUPERIORITY||average marginal effect|-0.6|||||TWO_SIDED|95.0|-3.0|1.8||||||||1.8|-3.0|
71068311|NCT02111577|141645351|SUPERIORITY|Adjusted by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Risk Ratio (RR)|0.845||||0.485|TWO_SIDED|95.0|0.528|1.355|||Log binomial model|||Stratified||1.355|0.528|0.485
71068312|NCT02111577|141645352|SUPERIORITY|Adjusted by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Risk Ratio (RR)|0.92||||0.768|TWO_SIDED|95.0|0.529|1.601|||Log binomial model|||Stratified||1.601|0.529|0.768
71068313|NCT04501640|141645381|OTHER||Geomteric Least Squares (LS) Mean Ratio|57.06|||||TWO_SIDED|90.0|46.21|70.47|||||Ratios and confidence intervals are transformed back to raw scale \& values are expressed as percentages.|Assessment based on an analysis of variance (ANOVA) performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.||70.47|46.21|
71068314|NCT04501640|141645381|OTHER||Geometric LSMean Ratio|61.42|||||TWO_SIDED|90.0|52.06|72.47|||||Ratios and confidence intervals are transformed back to raw scale \& values are expressed as percentages.|Assessment based on an ANOVA performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.||72.47|52.06|
71068315|NCT04501640|141645382|OTHER||Geomteric LSMean Ratio|53.31|||||TWO_SIDED|90.0|43.02|66.05|||||Ratios and confidence intervals are transformed back to raw scale \& values are expressed as percentages.|Assessment based on an ANOVA performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.||66.05|43.02|
71068316|NCT04501640|141645382|OTHER||Geomteric LSMean Ratio|59.14|||||TWO_SIDED|90.0|49.48|70.7|||||Ratios and confidence intervals are transformed back to raw scale \& values are expressed as percentages.|Assessment based on an ANOVA performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.||70.70|49.48|
71068317|NCT04501640|141645383|OTHER||Geometric LSMean Ratio|38.93|||||TWO_SIDED|90.0|26.78|56.59|||||Ratios and confidence intervals are transformed back to raw scale \& values are expressed as percentages.|Assessment based on an ANOVA performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.||56.59|26.78|
71068318|NCT04501640|141645383|OTHER||Geometric LSMean Ratio|47.9|||||TWO_SIDED|90.0|31.76|72.24|||||Ratios and confidence intervals are transformed back to raw scale \& values are expressed as percentages.|Assessment based on an ANOVA performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.||72.24|31.76|
71112607|NCT02229825|141732206|OTHER|||||||0.88||||||p-value for treatment effect|ANCOVA|ANCOVA with stratification factors (country and pretreatment) and baseline score and treatment as the main factor.||The null hypothesis was that the mean change in MADRS total score between week 4 and baseline was the same for the 2 duloxetine treatment groups.||||0.88
71112608|NCT02229825|141732207|OTHER|||||||0.86||||||Treatment effect.|ANCOVA|Analysis of covariance (ANCOVA) with stratification factors and HAMD6 baseline as covariates and treatment regimen as main factor.||Comparison between treatment regimes at Week 4.||||0.86
71112609|NCT02229825|141732208|OTHER||||||<|0.0001|||||||Signed Rank test|||Within-group comparisons, week 8 versus baseline.||||<0.0001
70852763|NCT01578850|141194342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|||<|0.001|TWO_SIDED|95.0|-1.33|-0.53|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 52||-0.53|-1.33|<0.001
71068319|NCT01981954|141645385|OTHER||||||<|0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 MCC Analysis||||<0.001
71068320|NCT01981954|141645387|OTHER|||||||0.003||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline=0.|t-test, 2 sided|||Week 24 Analysis||||0.003
71068321|NCT01981954|141645388|OTHER|||||||0.744||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.744
71068322|NCT01981954|141645389|OTHER|||||||0.352||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.352
71068323|NCT01981954|141645390|OTHER||||||<|0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||<0.001
71068324|NCT01981954|141645391|OTHER|||||||0.177||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.177
71068325|NCT01981954|141645392|OTHER|||||||0.025||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analyis||||0.025
71068326|NCT01981954|141645393|OTHER|||||||0.05||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.050
71068327|NCT01981954|141645394|OTHER|||||||0.567||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.567
71068328|NCT01981954|141645395|OTHER|||||||0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.001
71068329|NCT01981954|141645396|OTHER||||||<|0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||<0.001
71068330|NCT01981954|141645397|OTHER|||||||0.004||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.004
71068331|NCT01981954|141645398|OTHER|||||||0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.001
71068332|NCT01981954|141645399|OTHER|||||||0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.001
71068333|NCT01981954|141645416|OTHER|||||||0.688||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.688
71068334|NCT01981954|141645417|OTHER|||||||0.61||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.610
71068335|NCT01981954|141645418|OTHER|||||||0.562||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.562
71068336|NCT01981954|141645419|OTHER|||||||0.657||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.657
71112610|NCT02229825|141732208|OTHER||||||<|0.0001|||||||Singed Rank test|||Within-group comparison, week 8 versus baseline.||||<0.0001
71112611|NCT02229825|141732208|OTHER||||||<|0.0001|||||||Singed Rank test|||Within-group comparison, week 8 versus baseline.||||<0.0001
71112612|NCT02229825|141732208|OTHER||||||<|0.0001|||||||Signed Rank test|||Within-group comparison, week 8 versus baseline.||||<0.0001
70852764|NCT01578850|141194344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.048|TWO_SIDED|95.0|-1.0|-0.01|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 28||-0.01|-1.00|0.048
71068337|NCT01981954|141645420|OTHER|||||||0.631||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.631
71068338|NCT01981954|141645421|OTHER|||||||0.41||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.410
71068339|NCT01981954|141645422|OTHER|||||||0.94||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.940
71068340|NCT01981954|141645423|OTHER|||||||1||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||1.000
71068341|NCT01981954|141645424|OTHER|||||||0.575||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0|t-test, 2 sided|||Week 24 Analysis||||0.575
71068342|NCT01981954|141645425|OTHER|||||||0.031||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.031
71068343|NCT01981954|141645426|OTHER|||||||0.721||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.721
71068344|NCT03655470|141645427|SUPERIORITY||Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.07||0.3|TWO_SIDED||||||Mixed Models Analysis|||||||.30
71068345|NCT03063086|141645440|SUPERIORITY||Mean Difference (Final Values)|0.172|||<|0.0001|TWO_SIDED|95.0|0.137|0.208|||Mixed Models Analysis|||||0.208|0.137|<0.0001
71112613|NCT02229825|141732210|OTHER||||||<|0.0001|||||||McNemar|||Within group comparisons were performed at week 8 versus baseline.||||<0.0001
71112614|NCT02229825|141732210|OTHER||||||<|0.0001|||||||McNemar|||Within group comparisons were performed at week 8 versus baseline.||||<0.0001
71112615|NCT02229825|141732210|OTHER||||||<|0.0001|||||||McNemar|||Within group comparisons were performed at week 8 versus baseline.||||<0.0001
70941917|NCT01855997|141383978|SUPERIORITY_OR_OTHER|||||||8.02e-06|TWO_SIDED||||||t-test, 2 sided|||rs2279519||||0.00000802
71112616|NCT02229825|141732210|OTHER||||||<|0.0001|||||||McNemar|||Within group comparisons were performed at week 8 versus baseline.||||<0.0001
71112617|NCT02229825|141732211|OTHER|||||||0.32||||||Treatment effect.|Regression, Logistic|||Treatment groups were compared regarding the number of responders and non-responders at week 4, using a logistic regression with stratification factors (country and pretreatment) and baseline scores as covariates and treatment regimen as main factor.||||0.32
71068346|NCT03063086|141645440|SUPERIORITY||Median Difference (Final Values)|0.159|||<|0.0001|TWO_SIDED|95.0|0.123|0.195|||Mixed Models Analysis|||||0.195|0.123|<0.0001
70941918|NCT01855997|141383979|SUPERIORITY_OR_OTHER|||||||5.58e-06|TWO_SIDED||||||t-test, 2 sided|||rs12992677||||0.00000558
71068347|NCT03063086|141645445|SUPERIORITY||Mean Difference (Final Values)|0.124|||<|0.0001|TWO_SIDED|95.0|0.086|0.161|||Mixed Models Analysis|||||0.161|0.086|<0.0001
71068348|NCT04590586|141645446|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.6672|TWO_SIDED|95.0|0.59|2.35|||Stratified log-rank test|Stratified by baseline score of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), and geographic region.|Hazard ratio (Lanadelumab vs. placebo) from a Cox regression model including baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||2.35|0.59|0.6672
70941919|NCT01855997|141383980|SUPERIORITY_OR_OTHER|||||||9.9e-06|TWO_SIDED||||||t-test, 2 sided|||rs12992677||||0.00000990
70941920|NCT01855997|141383981|SUPERIORITY_OR_OTHER|||||||4.8e-07|TWO_SIDED||||||t-test, 2 sided|||rs7549785||||0.00000048
70941921|NCT01855997|141383982|SUPERIORITY_OR_OTHER|||||||4.8e-07|TWO_SIDED||||||t-test, 2 sided|||rs7549785||||0.00000048
70941922|NCT01855997|141383983|SUPERIORITY_OR_OTHER|||||||7.38e-06|TWO_SIDED||||||t-test, 2 sided|||rs10814834||||0.00000738
71068349|NCT04590586|141645447|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8779|TWO_SIDED|95.0|0.77|1.24|||Stratified log-rank test|Stratified by baseline score of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), and geographic region.|Hazard ratio (apremilast vs. placebo) from a Cox regression model including baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||1.24|0.77|0.8779
71079034|NCT00978341|141666048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.553||0.2843||95.0|-2.2|0.84|||ANOVA|||Difference from placebo (including Baseline), Day 8: 0.5 hours post-dose.||0.84|-2.20|0.2843
71079035|NCT00978341|141666048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.82||0.215||95.0|-2.75|0.65|||ANOVA|||Difference from placebo (including Baseline), Day 8: 1 hour post-dose.||0.65|-2.75|0.2150
71079036|NCT00978341|141666048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.189||0.9601||95.0|-0.44|0.42|||ANOVA|||Difference from placebo (including Baseline), Day 8: 2 hours post-dose.||0.42|-0.44|0.9601
71079037|NCT00978341|141666048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.311||0.867||95.0|-0.64|0.74|||ANOVA|||Difference from placebo (including baseline), Day 8: 3 hours post-dose.||0.74|-0.64|0.8670
71079038|NCT00978341|141666048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.393||0.9024||95.0|-0.94|0.84|||ANOVA|||Difference from placebo (including baseline), Day 8: 4 hours post-dose.||0.84|-0.94|0.9024
71079039|NCT00978341|141666048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.293||0.9708||95.0|-0.67|0.65|||ANOVA|||Difference from placebo (including Baseline), Day 8: 5 hours post-dose.||0.65|-0.67|0.9708
71079040|NCT00978341|141666048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.395||0.1078||95.0|-1.62|0.19|||ANOVA|||Difference from placebo (including Baseline), Day 8: 6 hours post-dose.||0.19|-1.62|0.1078
71079041|NCT00978341|141666048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.419||0.446||95.0|-1.28|0.61|||ANOVA|||Difference from placebo (including Baseline), Day 8: 8 hours post-dose.||0.61|-1.28|0.4460
71079042|NCT00978341|141666048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.394||0.5266||95.0|-1.13|0.62|||ANOVA|||Difference from placebo (including Baseline), Day 8: 10 hours post-dose.||0.62|-1.13|0.5266
71079043|NCT00978341|141666048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.273||0.029||95.0|-1.29|-0.08|||ANOVA|||Difference from placebo (including Baseline), Day 8: 12 hours post-dose.||-0.08|-1.29|0.0290
71079044|NCT00978341|141666048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.531||0.183||95.0|-2.01|0.45|||ANOVA|||Difference from placebo (including Baseline), Day 8: 24 hours post-dose.||0.45|-2.01|0.1830
71079045|NCT00978341|141666048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.406||0.9884||95.0|-0.9|0.91|||ANOVA|||Difference from placebo (including Baseline), Day 8: 36 hours post-dose.||0.91|-0.90|0.9884
71079046|NCT00978341|141666048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.354||0.8082||95.0|-0.87|0.69|||ANOVA|||Difference from placebo (including Baseline), Day 8: 48 hours post-dose.||0.69|-0.87|0.8082
71079047|NCT00978341|141666049|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.714||0.2101||95.0|-2.39|0.55|||ANOVA|||Difference from placebo (including baseline); Day 2. Combined analysis: values for the two patient groups were analyzed together using ANOVA and/or mixed models.||0.55|-2.39|0.2101
71079048|NCT00978341|141666049|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.623||0.1065||95.0|-2.33|0.24|||ANOVA|||Difference from placebo (including baseline); Day 3.||0.24|-2.33|0.1065
71079049|NCT00978341|141666049|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.254||0.0697||95.0|-1.11|0.05|||ANOVA|||Difference from placebo (including baseline); Day 4.||0.05|-1.11|0.0697
71079050|NCT00978341|141666049|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.65||0.4589||95.0|-1.83|0.85|||ANOVA|||Difference from placebo; Day 5.||0.85|-1.83|0.4589
71079051|NCT00978341|141666049|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|0.742||0.1326||95.0|-2.69|0.38|||ANOVA|||Difference from placebo; Day 6.||0.38|-2.69|0.1326
71079052|NCT00978341|141666049|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.638||0.282||95.0|-2.45|0.9|||ANOVA|||Difference from placebo (including baseline); Day 7.||0.90|-2.45|0.2820
71079053|NCT00978341|141666049|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.356||0.0108||95.0|-2.21|-0.44|||ANOVA|||Difference from placebo (including baseline); Day 8.||-0.44|-2.21|0.0108
71079054|NCT00978341|141666050|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.26|STANDARD_ERROR_OF_MEAN|19.06||0.9068||95.0|-41.78|37.27|||ANOVA|||Difference from placebo; Day 1: 4 hours post-dose (including Baseline).||37.27|-41.78|0.9068
71068350|NCT04590586|141645459|OTHER||Risk Difference (RD)|-4.0||||0.3773|TWO_SIDED|95.0|-12.9|4.9|||Regression, Logistic||Risk difference is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||4.9|-12.9|0.3773
71068351|NCT04590586|141645459|OTHER||Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.52|1.28|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||1.28|0.52|
71068352|NCT04590586|141645460|OTHER||Risk Difference (RD)|-2.9||||0.4846|TWO_SIDED|95.0|-11.2|5.3|||Regression, Logistic||Risk difference is from a logistic regression including baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||5.3|-11.2|0.4846
71068353|NCT04590586|141645460|OTHER||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.51|1.37|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||1.37|0.51|
71068354|NCT04590586|141645461|OTHER||Risk Difference (RD)|0.2||||0.9665|TWO_SIDED|95.0|-7.3|7.6|||Regression, Logistic||Risk difference is from a logistic regression including baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||7.6|-7.3|0.9665
71068355|NCT04590586|141645461|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.59|1.74|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||1.74|0.59|
71068356|NCT04590586|141645462|OTHER||Odds Ratio (OR)|1.02||||0.9119|TWO_SIDED|95.0|0.71|1.46|||Proportional odds model||Odds ratio (Apremilast vs. Placebo) from a proportional odds model including the baseline clinical severity of 2 on the 8-point ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), region, and treatment arm as factors.|Day 8||1.46|0.71|0.9119
71068357|NCT04590586|141645462|OTHER||Odds Ratio (OR)|1.09||||0.6475|TWO_SIDED|95.0|0.75|1.58|||Proportional odds model||Odds ratio (Apremilast vs. Placebo) from a proportional odds model including the baseline clinical severity of 2 on the 8-point ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), region, and treatment arm as factors.|Day 15||1.58|0.75|0.6475
71068358|NCT04590586|141645462|OTHER||Odds Ratio (OR)|0.98||||0.9071|TWO_SIDED|95.0|0.64|1.48|||Proportional odds model||Odds ratio (Apremilast vs. Placebo) from a proportional odds model including the baseline clinical severity of 2 on the 8-point ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), region, and treatment arm as factors.|Day 29||1.48|0.64|0.9071
71068359|NCT04590586|141645463|OTHER||Odds Ratio (OR)|1.15||||0.4507|TWO_SIDED|95.0|0.8|1.66|||Proportional odds model||Odds ratio (Apremilast vs. Placebo) from a proportional odds model including the baseline clinical severity of 2 on the 8-point ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), region, and treatment arm as factors.|||1.66|0.80|0.4507
71068360|NCT04590586|141645464|OTHER||Odds Ratio (OR)|0.99||||0.9741|TWO_SIDED|95.0|0.64|1.53|||Proportional odds model||Odds ratio (Apremilast vs. Placebo) from a proportional odds model including the baseline clinical severity of 2 on the 8-point ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), region, and treatment arm as factors.|||1.53|0.64|0.9741
71068361|NCT04590586|141645465|OTHER||Odds Ratio (OR)|1.04||||0.8754|TWO_SIDED|95.0|0.64|1.7|||Proportional odds model||Odds ratio (Apremilast vs. Placebo) from a proportional odds model including the baseline clinical severity of 2 on the 8-point ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), region, and treatment arm as factors.|||1.70|0.64|0.8754
70941923|NCT01855997|141383983|SUPERIORITY_OR_OTHER|||||||4.51e-06|TWO_SIDED||||||t-test, 2 sided|||rs10491723||||0.00000451
71068362|NCT04590586|141645466|OTHER||Risk Difference (RD)|0.2||||0.9695|TWO_SIDED|95.0|-8.7|9.1|||Regression, Logistic||Risk difference is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|Analysis of clinical recovery on Day 8||9.1|-8.7|0.9695
71068363|NCT04590586|141645466|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.64|1.59|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|Analysis of clinical recovery on Day 8||1.59|0.64|
71068364|NCT04590586|141645466|OTHER||Risk Difference (RD)|-2.4||||0.6236|TWO_SIDED|95.0|-11.9|7.1|||Regression, Logistic||Risk difference is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|Analysis of clinical recovery on Day 15||7.1|-11.9|0.6236
71068365|NCT04590586|141645466|OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.59|1.37|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|Analysis of clinical recovery on Day 15||1.37|0.59|
71068366|NCT04590586|141645466|OTHER||Risk Difference (RD)|-6.2||||0.1664|TWO_SIDED|95.0|-14.9|2.5|||Regression, Logistic||Risk difference is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|Analysis of clinical recovery on Day 29||2.5|-14.9|0.1664
70941924|NCT01855997|141383983|SUPERIORITY_OR_OTHER|||||||8.78e-06|TWO_SIDED||||||t-test, 2 sided|||rs6592052||||0.00000878
71068367|NCT04590586|141645466|OTHER||Odds Ratio (OR)|0.72|||||TWO_SIDED|95.0|0.45|1.15|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|Analysis of clinical recovery on Day 29||1.15|0.45|
71079055|NCT00978341|141666050|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.52|STANDARD_ERROR_OF_MEAN|15.813||0.7807||95.0|-30.53|39.57|||ANOVA|||Difference from placebo; Day 8: pre-dose (including Baseline).||39.57|-30.53|0.7807
71068368|NCT04590586|141645467|OTHER||Risk Difference (RD)|-0.5||||0.9043|TWO_SIDED|95.0|-9.3|8.3|||Regression, Logistic||Risk difference is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||8.3|-9.3|0.9043
71068369|NCT04590586|141645467|OTHER||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.62|1.54|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||1.54|0.62|
71068370|NCT02218736|141645479|SUPERIORITY|||||||0.0095|||||||t-test, 1 sided|||||||0.0095
71068371|NCT02218736|141645480|SUPERIORITY|||||||0.0345|||||||t-test, 1 sided|||||||0.0345
71068372|NCT02218736|141645481|SUPERIORITY|||||||0.43|||||||t-test, 1 sided|||||||0.430
71068373|NCT05481125|141645482|NON_INFERIORITY|Non-inferiority margin = 0.1 logMAR|Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.0125|||ONE_SIDED|95.0||-0.024||Since a non-inferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the non-inferiority margin.|||Mean difference (Clareon/Clareon Toric minus Eyhance/Eyhance Toric). Upper Confidence Limit is presented.|||-0.024||
71068374|NCT00422695|141645512|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
71068375|NCT00422695|141645512|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71068376|NCT04791319|141645513|SUPERIORITY||MH weights|7.1||||0.489|TWO_SIDED|95.0|-12.1|26.2||Threshold for significance at 0.05 level.|Chi-squared|||||26.2|-12.1|0.489
71068377|NCT04791319|141645513|SUPERIORITY||MH Weights|7.1||||0.448|TWO_SIDED|95.0|-9.4|23.7|||Chi-squared|||||23.7|-9.4|0.448
71068378|NCT04791319|141645513|SUPERIORITY||MH Weights|42.0||||0.001|TWO_SIDED|95.0|22.9|61.1|||Chi-squared|||||61.1|22.9|0.001
71068379|NCT05831644|141645592|SUPERIORITY||Mean Difference (Final Values)|-0.124||||0.1925|TWO_SIDED|90.0|-0.285|0.037|||ANOVA|||The primary endpoint (RHI score) was compared between treatments using an analysis of variance model (ANOVA) with treatment and period as fixed effects and subjects as random effect.||0.037|-0.285|0.1925
71068380|NCT05831644|141645593|SUPERIORITY||Mean Difference (Final Values)|-4.94||||0.1941|TWO_SIDED|90.0|-11.392|1.513|||ANOVA|||The secondary pharmacodynamic endpoint (AI) was analysed using a similar ANOVA model as for the primary endpoint.||1.513|-11.392|0.1941
70941925|NCT01855997|141383983|SUPERIORITY_OR_OTHER|||||||5.21e-06|TWO_SIDED||||||t-test, 2 sided|||rs16943470||||0.00000521
71068381|NCT03010800|141645614|SUPERIORITY|||||||0.0469||||||One subject experienced incontinence with the Yoni.Fit in place (#8) (9.2 g Pad Wt. Without and 17.3 g Pad Wt. With). This was attributed to incorrect Yoni.Fit sizing. This subject was not included in the p-value calculation.|Wilcoxon (Mann-Whitney)|||"Null hypothesis is that the pad weights With Yoni.Fit and Without Yoni.Fit are equivalent.~A one-sided Wilcoxson paired T-test of the group means will be performed. If the p-value is significant, the null hypothesis will be rejected."||||0.0469
71068382|NCT03386994|141645616|OTHER|||||||0.0002|||||||ANOVA|Total annual IPF-related costs||||||0.0002
71068383|NCT03386994|141645616|OTHER|||||||0.0007|||||||ANOVA|Annual direct health IPF-related costs||||||0.0007
71068384|NCT03386994|141645616|OTHER||||||<|0.0001|||||||ANOVA|Annual direct non-health IPF-related costs||||||<0.0001
71068385|NCT03386994|141645616|OTHER|||||||0.6839|||||||ANOVA|Annual indirect IPF-related costs||||||0.6839
71068386|NCT03386994|141645617|OTHER|||||||0.002|||||||Kruskal-Wallis|Timepoint: T0||||||0.0020
71068387|NCT03386994|141645617|OTHER|||||||0.1385|||||||Kruskal-Wallis|Timepoint: T6||||||0.1385
71068388|NCT03386994|141645617|OTHER|||||||0.0233|||||||Kruskal-Wallis|Timepoint: T12||||||0.0233
71068389|NCT03386994|141645618|OTHER|||||||0.156||||||Timepoint: T0|Kruskal-Wallis|||||||0.1560
71068390|NCT03386994|141645618|OTHER|||||||0.3144||||||Timepoint: T6|Kruskal-Wallis|||||||0.3144
71068391|NCT03386994|141645618|OTHER|||||||0.2019||||||Timepoint: T12|Kruskal-Wallis|||||||0.2019
71068392|NCT03386994|141645619|OTHER|||||||0.0075||||||Timepoint: T0|Kruskal-Wallis|||||||0.0075
71068393|NCT03386994|141645619|OTHER|||||||0.0361||||||Timepoint: T6|Kruskal-Wallis|||||||0.0361
70941926|NCT01855997|141383984|SUPERIORITY_OR_OTHER|||||||7.2e-06|TWO_SIDED||||||t-test, 2 sided|||rs6592052||||0.00000720
71068394|NCT03386994|141645619|OTHER|||||||0.4794||||||Timepoint: T12|Kruskal-Wallis|||||||0.4794
71068395|NCT03386994|141645620|OTHER|||||||0.0333|||||||Fisher Exact|||||||0.0333
71068396|NCT03386994|141645622|OTHER|||||||0.4711|||||||ANOVA|Total annual IPF-related costs||||||0.4711
71068397|NCT03386994|141645622|OTHER|||||||0.4095|||||||ANOVA|Annual direct health IPF-related costs||||||0.4095
71068398|NCT03386994|141645622|OTHER|||||||0.0435|||||||ANOVA|Annual direct non-health IPF-related costs||||||0.0435
71068399|NCT03386994|141645622|OTHER|||||||0.5479|||||||ANOVA|Annual indirect IPF-related costs||||||0.5479
71068400|NCT03386994|141645624|OTHER|||||||0.7486|||||||ANOVA|Total annual IPF-related costs||||||0.7486
71068401|NCT03386994|141645624|OTHER|||||||0.7652|||||||ANOVA|Annual direct health IPF-related costs||||||0.7652
71068402|NCT03386994|141645624|OTHER|||||||0.0037|||||||ANOVA|Annual direct non-health IPF-related costs||||||0.0037
71068403|NCT03386994|141645624|OTHER|||||||0.6119|||||||ANOVA|Annual indirect IPF-related costs||||||0.6119
71068404|NCT03386994|141645625|OTHER|||||||0.1581|||||||ANOVA|Total annual IPF-related costs||||||0.1581
71068405|NCT03386994|141645625|OTHER|||||||0.1581|||||||ANOVA|Annual direct health IPF-related costs||||||0.1581
71068406|NCT03386994|141645625|OTHER|||||||0.7165|||||||ANOVA|Annual direct non-health IPF-related costs||||||0.7165
71068407|NCT03386994|141645625|OTHER|||||||1|||||||ANOVA|Annual indirect IPF-related costs||||||1.0000
71068408|NCT03386994|141645626|OTHER|||||||0.0733|||||||Kruskal-Wallis|||||||0.0733
71068409|NCT03386994|141645628|OTHER|||||||0.0207|||||||Kruskal-Wallis|||||||0.0207
71068410|NCT03386994|141645629|OTHER|||||||0.0942|||||||Kruskal-Wallis|||||||0.0942
71068411|NCT03386994|141645630|OTHER|||||||0.0747|||||||Kruskal-Wallis|||||||0.0747
71068412|NCT03386994|141645632|OTHER|||||||0.1282|||||||Kruskal-Wallis|||||||0.1282
71068413|NCT03386994|141645633|OTHER|||||||0.7471|||||||Kruskal-Wallis|||||||0.7471
71079056|NCT00978341|141666050|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.51|STANDARD_ERROR_OF_MEAN|17.526||0.2293||95.0|-61.79|16.78|||ANOVA|||Difference from placebo; Day 8: 4 hours post-dose (including Baseline).||16.78|-61.79|0.2293
71068414|NCT02702388|141645646|NON_INFERIORITY|Odds ratio of ORR as of Week 24 response (18 mg vs 24 mg) along with its 95% confidence interval (CI) using the Cochran-Mantel-Haenszel (CMH) method, stratified by the randomization stratification factors. The test was performed per the 95% CI using the noninferiority margin of 0.4. Noninferiority will be declared if the lower limit of the 95% CI for the odds ratio is greater than 0.4.|Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.26|0.96||||||||0.96|0.26|
71068415|NCT02729051|141645679|NON_INFERIORITY|If the lower bound of the two-sided 95% confidence interval around the (FF/UMEC/VI versus FF/VI+UMEC) treatment difference is above -50 milliliter (mL) then FF/UMEC/VI was to be considered non-inferior to FF/VI+UMEC.|Mean Difference (Final Values)|0.018|STANDARD_ERROR_OF_MEAN|0.0161|||TWO_SIDED|95.0|-0.013|0.05|||||MMRM method included covariates of Baseline FEV1, stratum (number of long-acting bronchodilators per day during the run-in: 0/1 or 2), visit, geographical region, treatment, visit by treatment and visit by Baseline interaction.|||0.050|-0.013|
71068416|NCT02729051|141645680|OTHER||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.71|1.2|||||Analysis included covariates of treatment group, stratum (number of long-acting bronchodilators per day during the run-in: 0/1 or 2), geographical region, visit, Baseline, Baseline by visit and treatment by visit interactions.|||1.20|0.71|
71068417|NCT02729051|141645681|OTHER||Least Square Mean Difference|-0.906|STANDARD_ERROR_OF_MEAN|0.8327|||TWO_SIDED|95.0|-2.54|0.728|||||Analysis performed using a repeated measures model with covariates of Baseline SGRQ, stratum (number of long-acting bronchodilators per day during the run-in: 0/1 or 2), visit, geographical region, treatment, visit by treatment and visit by Baseline.|||0.728|-2.540|
71068418|NCT02729051|141645682|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.72|1.25|||||Include covariates of treatment group, stratum (number of long-acting bronchodilators/ day during the run-in: 0/1 or 2), geographical region, visit, Baseline dyspnea index (BDI) focal score, BDI focal score/ visit and treatment/ visit interactions.|||1.25|0.72|
71068419|NCT02729051|141645683|OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.1773|||TWO_SIDED|95.0|-0.211|0.485|||||Analysis included covariates of BDI focal score, stratum (number of long-acting bronchodilators per day during the run-in: 0/1 or 2), visit, geographical region, treatment, visit by treatment and visit by BDI Focal score interactions.|||0.485|-0.211|
71068420|NCT02729051|141645684|OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.68|1.12|||||Analysis was performed using a Cox proportional hazards model.|||1.12|0.68|
71068421|NCT04445714|141645713|SUPERIORITY||Mean Difference (Final Values)|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.34|-1.03|||Paired t-test test|||Change from baseline||-1.03|-1.34|<.0001
71068422|NCT04445714|141645714|SUPERIORITY||Mean Difference (Final Values)|-2.1|||<|0.0001|TWO_SIDED|95.0|-2.66|-1.51|||Paired t-test test|||Change from baseline||-1.51|-2.66|<.0001
71068423|NCT04445714|141645715|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.8416|TWO_SIDED|95.0|-2.34|1.91|||Paired t-test test|||Change from baseline||1.91|-2.34|0.8416
71068424|NCT04445714|141645716|SUPERIORITY||Mean Difference (Final Values)|-24.4|||<|0.0001|TWO_SIDED|95.0|-33.4|-15.4|||Paired t-test test|||Change from baseline||-15.4|-33.4|<.0001
71068425|NCT02805660|141645718|SUPERIORITY|An exact test for single proportion was performed to test null hypothesis (H0): ORR \<= 5% against alternative hypothesis (H1): ORR \> 5% for Cohorts 1, 3, and 4 and to test H0: ORR \<= 27% against H1: ORR \> 27% for Cohort 2.||||||0.537|||||||Exact Test|||||||0.537
71068426|NCT02805660|141645718|SUPERIORITY|An exact test for single proportion was performed to test null hypothesis (H0): ORR \<= 5% against alternative hypothesis (H1): ORR \> 5% for Cohorts 1, 3, and 4 and to test H0: ORR \<= 27% against H1: ORR \> 27% for Cohort 2.|||||>|0.999|||||||Exact Test|||||||>0.999
71068427|NCT02805660|141645718|SUPERIORITY|An exact test for single proportion was performed to test null hypothesis (H0): ORR \<= 5% against alternative hypothesis (H1): ORR \> 5% for Cohorts 1, 3, and 4 and to test H0: ORR \<= 27% against H1: ORR \> 27% for Cohort 2.||||||0.283|||||||Exact Test|||||||0.283
71068428|NCT02805660|141645718|SUPERIORITY|An exact test for single proportion was performed to test null hypothesis (H0): ORR \<= 5% against alternative hypothesis (H1): ORR \> 5% for Cohorts 1, 3, and 4 and to test H0: ORR \<= 27% against H1: ORR \> 27% for Cohort 2.||||||0.025|||||||Exact Test|||||||0.025
71068429|NCT04223635|141645735|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Interval (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|92.6|||||TWO_SIDED|90.0|54.38|157.69|||||For the comparison, moderate HI represents the numerator and normal HF represents the denominator.|||157.69|54.38|
71068430|NCT04223635|141645737|OTHER|Least squares means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric Least Square Mean|147.17|||||TWO_SIDED|90.0|95.39|227.07|||||For the comparison, moderate HI represents the numerator and normal HF represents the denominator.|||227.07|95.39|
71068431|NCT04223635|141645738|OTHER|Least squares means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric Least Square Mean|142.87|||||TWO_SIDED|90.0|91.21|223.79|||||For the comparison, moderate HI represents the numerator and normal HF represents the denominator.|||223.79|91.21|
71068432|NCT01399047|141645755|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.105||||0.21|TWO_SIDED|95.0|-0.033|0.243|||Prescott's test||Mycophenolate was tolerated in 17/19 subjects (89.5%, 95% CI: 66.9% - 98.7%), while placebo was tolerated in 19/19 subjects (100%, 95% CI: 82.4% - 100%). The difference in tolerability rates was 10.5% (95% CI: -3.3% - 24.3%, p=0.21).|The primary outcome variable was tolerability, defined as the proportion of subjects able to complete 8 weeks on the assigned treatment. Tolerability was compared among the treatment groups using Prescott's test. A 95% confidence interval was computed for the tolerability of mycophenolate, placebo, and their difference.||0.243|-0.033|0.21
71068433|NCT01399047|141645756|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.69||||0.72|TWO_SIDED|95.0|-4.67|3.28|||Prescott's test|||||3.28|-4.67|0.72
71068434|NCT01399047|141645757|SUPERIORITY|||||||0.78|||||||Prescott's test|||||||0.78
71068435|NCT01399047|141645758|SUPERIORITY|||||||0.98|||||||Prescott's test|||||||0.98
71068436|NCT01399047|141645759|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.26
71068437|NCT02046005|141645760|SUPERIORITY||Risk Ratio (RR)|1.23||||0.043|TWO_SIDED|95.0|1.01|1.51||We compared the PRE-RA group (PRE-RA arm and PRE-RA Plus arm combined) to the Comparison arm for the primary composite outcome at the 3 primary post-intervention time points using generalized estimating equations (GEE).|generalized estimating equations||PRE-RA group (combined PRE-RA arm and PRE-RA Plus arm) compared to Comparison arm (reference)|"In the primary analysis, we combined the PRE-RA and PRE-RA Plus arms into a single PRE-RA group and compared it to the Comparison arm (aka General Rheumatoid Arthritis Education)"||1.51|1.01|0.043
71068438|NCT00251303|141645761|SUPERIORITY_OR_OTHER|||||||0.959||95.0|||||Chi-squared|||||||0.959
71068439|NCT04532619|141645763|SUPERIORITY||Slope|0.5||||0.014|TWO_SIDED|95.0|0.1|0.89||Computed p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.||0.89|0.10|0.014
71068440|NCT04532619|141645764|SUPERIORITY||Slope|-0.05||||0.8|TWO_SIDED|95.0|-0.41|0.32||computed p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.||0.32|-0.41|0.80
71068441|NCT04532619|141645765|SUPERIORITY||Slope|-0.29||||0.009|TWO_SIDED|95.0|-0.51|-0.07||computed p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.||-0.07|-0.51|0.009
71068442|NCT04532619|141645766|SUPERIORITY||Slope|0.17||||0.118|TWO_SIDED|95.0|-0.04|0.38||calculated p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.||0.38|-0.04|0.118
71068443|NCT04532619|141645767|SUPERIORITY||Odds Ratio, log|-0.9|STANDARD_ERROR_OF_MEAN|0.77||0.24|TWO_SIDED|||||computed p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology. A logistic link function was used for this binary outcome.||||.24
71068444|NCT04532619|141645768|SUPERIORITY||Slope|-1.33||||0.43|TWO_SIDED|95.0|-4.64|1.98||computed p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.||1.98|-4.64|0.43
71068445|NCT04532619|141645769|SUPERIORITY||Slope|-2.06||||0.07|TWO_SIDED|95.0|-4.27|0.15||computed p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.||0.15|-4.27|0.07
71068446|NCT00504725|141645770|SUPERIORITY_OR_OTHER|||||||0.39||95.0||||We will use two way ANOVA (looking for effects due to drug and time) with a p value of 0.05 indicative of statistical significance.|ANOVA|||IL-6||||0.39
71068447|NCT00504725|141645770|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||IL-8||||0.18
71068448|NCT00504725|141645770|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||IL-10||||0.14
71068449|NCT00504725|141645771|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||ANOVA|||||||0.37
71068450|NCT00504725|141645772|SUPERIORITY_OR_OTHER|||||||0.44||95.0||||Baseline Pain Level Score|Fisher Exact|||||||0.44
71068451|NCT00504725|141645772|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||4 Hour Pain Level Score|Fisher Exact|||||||0.20
71068452|NCT00504725|141645772|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||24 Hour Pain Level Score|Fisher Exact|||||||0.37
71068453|NCT00504725|141645772|SUPERIORITY_OR_OTHER|||||||0.15||95.0||||Pain Level Score at Discharge|Fisher Exact|||||||0.15
71068454|NCT00769067|141645784|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.657||||0.012|TWO_SIDED|95.0|0.472|0.914||2-Sided.|Log Rank|Adjusted for the stratification factors: EGFR status, KRAS status and baseline ECOG performance status.|The estimated HR was for the Dacomitinib arm versus the Erlotinib arm.|"Total 128 events (progression/death) provided 80% power to detect a hazard ratio (HR) of 1.45 (Erlotinib versus Dacomitinib arm) with 1-sided alpha=0.10.This represented a 45% improvement in true median PFS.~HR and 95% confidence interval estimated from stratified Cox Regression;2-sided p-value was based on stratified log-rank test with epidermal growth factor receptor (EGFR) status, Kirsten Rat Sarcoma status (KRAS), baseline Eastern Cooperative Oncology Group (ECOG) as stratification factors"||0.914|0.472|0.012
71068455|NCT00769067|141645785|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|||||2-Sided.|Chi-squared|Unadjusted.||||||0.011
71079057|NCT00978341|141666051|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.386||0.3774||95.0|-0.54|1.27|||ANOVA|||Difference from placebo (including Baseline); Day 1: 0.5 hours post-dose.||1.27|-0.54|0.3774
70852765|NCT01578850|141194344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|||<|0.001|TWO_SIDED|95.0|-1.44|-0.43|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 36||-0.43|-1.44|<0.001
71068456|NCT00769067|141645788|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.822||||0.252|TWO_SIDED|95.0|0.587|1.151||2-Sided.|Log Rank|Adjusted by stratification factors: EGFR status, KRAS status and baseline ECOG performance status.|The estimated HR was for the Dacomitinib arm versus the Erlotinib arm.|HR and its 95% confidence interval were estimated from stratified Cox Regression and 2-sided p-value was based on the stratified log-rank test with EGFR status, KRAS status and baseline ECOG as stratification factors.||1.151|0.587|0.252
71068457|NCT03625466|141645789|SUPERIORITY||Mean Difference|-1.5|||||TWO_SIDED|95.0|-5.5|2.6||||||||2.6|-5.5|
71068458|NCT02028767|141645809|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.57|STANDARD_ERROR_OF_MEAN|1.024||0|TWO_SIDED|90.0|94.662|102.639||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log scale: sequence, period and treatment as fixed effects; subjects within sequences as random effect"|||102.639|94.662|0.0000
71068459|NCT02028767|141645809|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.71|STANDARD_ERROR_OF_MEAN|1.024|<|0.0001|TWO_SIDED|90.0|94.783|102.796||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log-scale: sequence, subjects within sequences, period and treatment as fixed effects"|Analysis with fixed effects for all terms||102.796|94.783|<0.0001
71068460|NCT02028767|141645810|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.93|STANDARD_ERROR_OF_MEAN|1.019||0|TWO_SIDED|90.0|95.856|102.107||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log-scale: sequence, period and treatment as fixed effects; subjects within sequences as random effect"|||102.107|95.856|0.0000
71112618|NCT02229825|141732213|OTHER|||||||0.57||||||Treatment effect.|Regression, Logistic|||Treatment groups were compared regarding the number of responders and non-responders at week 4, using a logistic regression with stratification factors (country and pretreatment) and baseline scores as covariates and treatment regimen as main factor.||||0.57
71112619|NCT02229825|141732216|OTHER|||||||0.68|||||||Cochran-Mantel-Haenszel|Stratified by country, 60 mg vs. 120 mg||"At week 4 CGI-S items were pooled to reduce the possible number of classes before formal testing. The 3 classes used (instead of 7 items) were: 1-2: normal, 3-5: moderate, 6-7: severe. Treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre."||||0.68
71112620|NCT02229825|141732217|OTHER||Statistic|-528.0|||<|0.0001|||||||Signed Rank test||Difference is value at week 8 minus week 4.|At week 8, within-group comparison versus week 4 was performed.||||<0.0001
71112621|NCT02229825|141732217|OTHER||Statistic|-540.0|||<|0.0001|||||||Signed Rank test||Difference is value at week 8 minus week 4.|At week 8, within-group comparison versus week 4 was performed.||||<0.0001
71112622|NCT02229825|141732217|OTHER||Statistic|-1024.5|||<|0.0001|||||||Signed Rank test||Difference is value at week 8 minus week 4.|At week 8, within-group comparison versus week 4 was performed.||||<0.0001
71112623|NCT02229825|141732217|OTHER||Statistic|-279.0|||<|0.0001|||||||Signed Rank test||Difference is value at week 8 minus week 4.|At week 8, within-group comparison versus week 4 was performed.||||<0.0001
71112624|NCT02229825|141732218|OTHER|No formal hypothesis was tested.||||||0.07||||||Stratified by country, 60 mg vs. 120 mg|Cochran-Mantel-Haenszel|||"At week 4 CGI-S items were pooled to reduce the possible number of classes before formal testing. The 3 classes used (instead of 7 items) were: 1-2: normal, 3-5: moderate, 6-7: severe. Treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre."||||0.07
71112625|NCT02229825|141732220|OTHER||CMH statistic|0.0||||1|||||||Cochran-Mantel-Haenszel|||"Before testing, PGI-I items were pooled to reduce the possible number of classes. The 3 classes used (instead of 7 items) were: 1-2= improved, 3-5=Stable, 6-7=Worsened. At week 4 treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre."||||1.00
71112626|NCT02229825|141732222|OTHER|||||||0.92||||||Treatment effect|ANCOVA|||Comparison between HAMA scores between treatment regimens.||||0.92
71112627|NCT02229825|141732223|OTHER||||||<|0.0001|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||<0.0001
71112628|NCT02229825|141732223|OTHER||||||<|0.0001|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||<0.0001
71112629|NCT02229825|141732223|OTHER||||||<|0.0001|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||<0.0001
71112630|NCT02229825|141732223|OTHER||||||<|0.0001|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||<0.0001
71112631|NCT02229825|141732225|OTHER||||||<|0.0001|||||||Student statistic t-test|||Within-group comparison, Week 8 versus baseline.||||<0.0001
71112632|NCT02229825|141732225|OTHER|||||||0.001|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||0.001
71112633|NCT02229825|141732225|OTHER||||||<|0.0001|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||<0.0001
71028412|NCT00721409|141564205|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.93||||0.0471|TWO_SIDED|95.0|0.91|4.08||1-sided p-value is from the stratified exact test (1-sided, α =0.10)|Cochran-Mantel-Haenszel|||Objective Response CI was calculated using the exact Clopper-Pearson method. The stratified analysis presented above was based on CMH test stratified by Part. An Odds Ratio \>1 means better response in favor of palbociclib + letrozole arm.||4.08|0.91|0.0471
71079058|NCT00978341|141666051|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.215||0.4153||95.0|-0.33|0.7|||ANOVA|||Difference from placebo (including Baseline); Day 1: 1 hour post-dose.||0.70|-0.33|0.4153
70852766|NCT01578850|141194344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.001|TWO_SIDED|95.0|-1.33|-0.33|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 44||-0.33|-1.33|0.001
71028413|NCT00721409|141564205|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.34||||0.118|TWO_SIDED|95.0|0.65|8.66||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.||8.66|0.65|0.1180
71028414|NCT00721409|141564205|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.72||||0.1631|TWO_SIDED|95.0|0.65|4.54||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.||4.54|0.65|0.1631
71028415|NCT00721409|141564207|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.18||||0.0009|TWO_SIDED|95.0|1.48|6.98||1-sided p-value is from the stratified exact test (1-sided, α =0.10).|Cochran-Mantel-Haenszel|||CBR CI was calculated using the exact Clopper-Pearson method. The stratified analysis presented above was based on CMH test stratified by Part. An Odds Ratio \>1 means better response in favor of palbociclib + letrozole arm.||6.98|1.48|0.0009
71028416|NCT00721409|141564207|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.18||||0.0065|TWO_SIDED|95.0|1.3|13.9||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.||13.90|1.30|0.0065
71028417|NCT00721409|141564207|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.55||||0.0442|TWO_SIDED|95.0|0.89|7.7||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.||7.70|0.89|0.0442
71028418|NCT00721409|141564208|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.399|||<|0.0001|TWO_SIDED|95.0|0.265|0.601||1-sided p-value is from the stratified log-rank test (α =0.10).|Log Rank|||Kaplan-Meier method was applied for median and 95% CI. Hazard ratio was based on assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of palbociclib + letrozole.||0.601|0.265|<0.0001
70852767|NCT01578850|141194344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.002|TWO_SIDED|95.0|-1.33|-0.31|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 52||-0.31|-1.33|0.002
71068461|NCT02028767|141645810|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.96|STANDARD_ERROR_OF_MEAN|1.019|<|0.0001|TWO_SIDED|90.0|95.877|102.15||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log-scale: sequence, subjects within sequences, period and treatment as fixed effects"|Analysis with fixed effects for all terms||102.150|95.877|<0.0001
71068462|NCT02028767|141645811|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.28|STANDARD_ERROR_OF_MEAN|1.023||0|TWO_SIDED|90.0|94.549|102.156||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log-scale: sequence, period and treatment as fixed effects; subjects within sequences as random effect"|||102.156|94.549|0.0000
71068463|NCT02028767|141645811|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.35|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|90.0|94.603|102.252|||ANOVA|The p-value relates to the null hypothesis of non-equivalence.|"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log-scale: sequence, subjects within sequences, period and treatment as fixed effects"|Analysis with fixed effects for all terms||102.252|94.603|<0.0001
71068464|NCT03521115|141645813|SUPERIORITY||Odds Ratio (OR)|0.4|||<|0.01|TWO_SIDED||||||Regression, Logistic|b=-.91, controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.||6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.01
71068465|NCT03521115|141645813|SUPERIORITY||Odds Ratio (OR)|0.58|||<|0.1|TWO_SIDED||||||Regression, Logistic||Controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.10
71068466|NCT03521115|141645813|SUPERIORITY||Chi-Square|5.129||||0.077|TWO_SIDED||||||Chi-squared|||18 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. All controls were assigned 0 dosage.||||.077
71068467|NCT03521115|141645814|SUPERIORITY||b|-0.47|||<|0.001|TWO_SIDED||||||Regression, Linear|Controled for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.||6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.001
71068468|NCT03521115|141645814|SUPERIORITY||b|-0.97|||<|0.01|TWO_SIDED||||||Regression, Linear|Controlled for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.||12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.01
71068469|NCT03521115|141645814|SUPERIORITY||F|0.85|||>|0.1|TWO_SIDED||||||ANOVA|||18 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. All controls were assigned 0 dosage.||||>0.10
71068470|NCT03521115|141645815|SUPERIORITY||b|-0.22|||<|0.1|TWO_SIDED||||||Regression, Linear||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.10
71068471|NCT03521115|141645815|SUPERIORITY||b|-0.24|||<|0.05|TWO_SIDED||||||Regression, Linear||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.05
71068472|NCT03521115|141645815|SUPERIORITY||F|0.43|||>|0.1|TWO_SIDED||||||ANOVA|||18 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. All controls were assigned 0 dosage.||||>0.10
71079059|NCT00978341|141666051|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.48||||0.147||95.0|-0.23|1.2|||ANOVA|||Difference from placebo (including Baseline); Day 1: 2 hours post-dose.||1.20|-0.23|0.1470
71079060|NCT00978341|141666051|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.3||0.1862||95.0|-1.18|0.29|||ANOVA|||Difference from placebo (including Baseline); Day 1: 3 hours post-dose.||0.29|-1.18|0.1862
70852768|NCT01578850|141194346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.11||||0.033|TWO_SIDED|95.0|-27.07|-1.16|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 28||-1.16|-27.07|0.033
70852769|NCT01578850|141194346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.04||||0.013|TWO_SIDED|95.0|-30.39|-3.68|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 36||-3.68|-30.39|0.013
71068473|NCT03521115|141645816|SUPERIORITY||b|-0.16|||<|0.1|TWO_SIDED||||||Regression, Linear|Controlled for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.||6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<.10
71068474|NCT03521115|141645816|SUPERIORITY||b|-0.26|||<|0.05|TWO_SIDED||||||Regression, Linear|Controlled for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.||12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.05
71068475|NCT03521115|141645816|SUPERIORITY||F|1.55|||>|0.1|TWO_SIDED||||||ANOVA|||18 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. All controls were assigned 0 dosage.||||>0.10
71079061|NCT00978341|141666051|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.22||0.8321||95.0|-0.45|0.55|||ANOVA|||Difference from placebo (including Baseline); Day 1: 4 hours post-dose.||0.55|-0.45|0.8321
71079062|NCT00978341|141666051|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.269||0.4251||95.0|-0.42|0.88|||ANOVA|||Difference from placebo (including Baseline); Day 1: 5 hours post-dose.||0.88|-0.42|0.4251
71079063|NCT00978341|141666051|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.269||0.6394||95.0|-0.53|0.8|||ANOVA|||Difference from placebo (including Baseline); Day 1: 6 hours post-dose.||0.80|-0.53|0.6394
70852770|NCT01578850|141194346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.54||||0.019|TWO_SIDED|95.0|-30.35|-2.73|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 44||-2.73|-30.35|0.019
71079064|NCT00978341|141666051|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.302||0.9964||95.0|-0.68|0.68|||ANOVA|||Difference from placebo (including Baseline); Day 8: pre-dose.||0.68|-0.68|0.9964
71079065|NCT00978341|141666051|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.324||0.3638||95.0|-0.47|1.11|||ANOVA|||Difference from placebo (including Baseline); Day 8: 0.5 hours post-dose.||1.11|-0.47|0.3638
71079066|NCT00978341|141666051|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.223||0.1202||95.0|-0.15|0.99|||ANOVA|||Difference from placebo (including Baseline); Day 8: 1 hour post-dose.||0.99|-0.15|0.1202
71079067|NCT00978341|141666051|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.355||0.1204||95.0|-0.19|1.39|||ANOVA|||Difference from placebo (including Baseline); Day 8: 2 hours post-dose.||1.39|-0.19|0.1204
71079068|NCT00978341|141666051|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.289||0.4213||95.0|-0.44|0.93|||ANOVA|||Difference from placebo (including Baseline); Day 8: 3 hours post-dose.||0.93|-0.44|0.4213
71079069|NCT00978341|141666051|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.205||0.6028||95.0|-0.34|0.56|||ANOVA|||Difference from placebo (including Baseline); Day 8: 4 hours post-dose.||0.56|-0.34|0.6028
71079070|NCT00978341|141666051|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.491||0.3624||95.0|-0.68|1.64|||ANOVA|||Difference from placebo (including Baseline); Day 8: 5 hours post-dose.||1.64|-0.68|0.3624
71079071|NCT00978341|141666051|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.461||0.3163||95.0|-0.52|1.49|||ANOVA|||Difference from placebo (including Baseline); Day 8: 6 hours post-dose.||1.49|-0.52|0.3163
71079072|NCT00978341|141666052|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.39|STANDARD_ERROR_OF_MEAN|9.738||0.5919||95.0|-16.26|27.04|||ANOVA|||Difference from placebo (including Baseline); Day 1.||27.04|-16.26|0.5919
71079073|NCT00978341|141666052|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.58|STANDARD_ERROR_OF_MEAN|14.603||0.3981||95.0|-17.7|42.87|||ANOVA|||Difference from placebo (including Baseline); Day 8: pre-dose.||42.87|-17.70|0.3981
71079074|NCT00978341|141666052|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.64|STANDARD_ERROR_OF_MEAN|12.123||0.8314||95.0|-24.0|29.28|||ANOVA|||Difference from placebo (including Baseline); Day 8: 4 hours post-dose.||29.28|-24.00|0.8314
71079075|NCT00978341|141666053|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.054||0.7569||95.0|-0.14|0.1|||ANOVA|||Difference from placebo (including Baseline); Day 1: 2 hours post-dose.||0.10|-0.14|0.7569
71079076|NCT00978341|141666053|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.09||0.4814||95.0|-0.26|0.13|||ANOVA|||Difference from placebo (including Baseline); Day 1: 4 hours post-dose.||0.13|-0.26|0.4814
71079077|NCT00978341|141666053|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.143||0.6222||95.0|-0.37|0.23|||ANOVA|||Difference from placebo (including Baseline); Day 1: 6 hours post-dose.||0.23|-0.37|0.6222
71079078|NCT00978341|141666053|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.113||0.3035||95.0|-0.35|0.12|||ANOVA|||Difference from placebo (including Baseline); Day 8: pre-dose.||0.12|-0.35|0.3035
71079079|NCT00978341|141666053|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.122||0.1881||95.0|-0.42|0.09|||ANOVA|||Difference from placebo (including Baseline); Day 8: 2 hours post-dose.||0.09|-0.42|0.1881
71068476|NCT03521115|141645817|SUPERIORITY||b|-0.35|||<|0.05|TWO_SIDED||||||Regression, Linear||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.05
71068477|NCT03521115|141645817|SUPERIORITY||b|-0.02|||>|0.1|TWO_SIDED||||||Regression, Linear||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||>0.10
70941927|NCT03866434|141384006|EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%.|% ratio of Geometric LSmeans|64.225|||||TWO_SIDED|90.0|53.212|77.516|||ANOVA|A 2-factor analysis of variance (ANOVA) model with fixed factors for treatment and participant was fitted to the natural logtransformed PK parameters.|This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole \[Day 8\] versus anagrelide alone \[Day 1\]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the least squares (LS) mean difference in the log-transformed parameters back transformed to the original scale) and their 90 percent (%) confidence intervals (CI) were calculated.||77.516|53.212|
71068478|NCT03521115|141645818|SUPERIORITY||b|0.299|||<|0.01|TWO_SIDED||||||generalized estimating equations||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.01
71068479|NCT03521115|141645819|SUPERIORITY||b|0.268|||<|0.03|TWO_SIDED||||||generalized estimating equations|||Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<.03
71068480|NCT03521115|141645820|SUPERIORITY||b|0.075|||>|0.1|TWO_SIDED||||||generalized estimating equations||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||>0.10
71068481|NCT03521115|141645821|SUPERIORITY||b|0.051|||>|0.1|TWO_SIDED||||||generalized estimating equations||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||>0.10
71068482|NCT03521115|141645822|SUPERIORITY||b|0.72|||<|0.05|TWO_SIDED||||||generalized estimating equations|||Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.05
71112634|NCT02229825|141732225|OTHER|||||||0.28|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||0.28
71112635|NCT00803361|141732291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.62||||0.006|TWO_SIDED|95.0|-2.76|-0.48||p-value is for Change from Baseline.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-0.48|-2.76|0.006
71112636|NCT00803361|141732292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.56||||0.024|TWO_SIDED|95.0|-4.78|-0.34||p-value is for Change from Baseline|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-0.34|-4.78|0.024
71112637|NCT00803361|141732293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.004|TWO_SIDED|95.0|-0.74|-0.15|||ANOVA|||||-0.15|-0.74|0.004
71112638|NCT00803361|141732294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.125|TWO_SIDED|95.0|-0.93|0.11||p-value is for Severity of Worst Pain Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.11|-0.93|0.125
71112639|NCT00803361|141732294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.014|TWO_SIDED|95.0|-0.75|-0.09||p-value is for Severity of Least Pain Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-0.09|-0.75|0.014
71112640|NCT00803361|141732294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.012|TWO_SIDED|95.0|-0.93|-0.11||p-value is for Severity of Average Pain Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-0.11|-0.93|0.012
71112641|NCT00803361|141732294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.002|TWO_SIDED|95.0|-1.14|-0.25||p-value is for Severity of Pain Right Now Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-0.25|-1.14|0.002
71068483|NCT03521115|141645823|SUPERIORITY||||||>|0.1|||||||Chi-squared|||Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||>0.10
71068484|NCT01471340|141645824|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The projected sample size provided 90% power at a 2.5% alpha level (one-sided) to determine non-inferiority of MF/F and MF. For analysis of the first SAO in participants, MF/F MDI BID was considered non-inferior to MF MDI BID if the upper bound for the 95% confidence interval (CI) of the hazard ratio (HR) of MF/F MDI BID versus MF MDI BID was lower than 2.0 (noninferiority margin).|Hazard Ratio (HR)|1.22||||0.411|TWO_SIDED|95.0|0.76|1.94|||Cox proportional-hazard model||The HR and 95% CI were based on the Cox proportional-hazard model with covariates of treatment (MF/F or MF) and ICS dose level (200 or 400 mcg).|Pertains only to the First SAO; pooled MF/F treatments and pooled MF treatments||1.94|0.76|0.411
71068485|NCT01471340|141645825|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.89||||0.021|TWO_SIDED|95.0|0.8|0.98|||Cox proportional-hazard model|Superiority of MF/F MDI BID vs MF MDI BID was determined if the HR was less than 1 and achieved statistical significance (one-sided p-value \< 0.025).|The HR and 95% CI were based on the Cox proportional-hazard model with covariates of treatment (MF/F or MF) and ICS dose level (200 or 400 mcg).|Pertains only to the First SAEX; pooled MF/F treatments and pooled MF treatments||0.98|0.80|0.021
70852771|NCT01578850|141194346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.66||||0.007|TWO_SIDED|95.0|-33.78|-5.54|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 52||-5.54|-33.78|0.007
71068486|NCT00526669|141645827|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||Biomarker: TS|Wilcoxon signed rank test|||||||0.10
71068487|NCT00526669|141645827|SUPERIORITY_OR_OTHER|||||||0.097||95.0||||Biomarker: DPD|Wilcoxon signed rank test|||||||0.097
71112642|NCT00803361|141732294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.101|TWO_SIDED|95.0|-0.87|0.08||p-value is for Interference of Pain, General Activity, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.08|-0.87|0.101
71112643|NCT00803361|141732294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.252|TWO_SIDED|95.0|-0.83|0.22||p-value is for Interference of Pain, Mood, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.22|-0.83|0.252
71112644|NCT00803361|141732294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.149|TWO_SIDED|95.0|-0.72|0.11||p-value is for Interference of Pain,Walking Ability, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.11|-0.72|0.149
71112645|NCT00803361|141732294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.367|TWO_SIDED|95.0|-0.71|0.26||p-value is for Interference of Pain, Normal Work, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.26|-0.71|0.367
71112646|NCT00803361|141732294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.395|TWO_SIDED|95.0|-0.59|0.24||p-value is for Interference of Pain, Relations with Others, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.24|-0.59|0.395
71112647|NCT00803361|141732294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.731|TWO_SIDED|95.0|-0.63|0.44||p-value is for Interference of Pain, Sleep, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.44|-0.63|0.731
71112648|NCT00803361|141732294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.186|TWO_SIDED|95.0|-0.85|0.17||p-value is for Interference of Pain, Enjoyment of Life, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.17|-0.85|0.186
71112649|NCT00803361|141732294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.22|TWO_SIDED|95.0|-0.67|0.16||p-value is for Mean Interference Score, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.16|-0.67|0.220
71068488|NCT00526669|141645827|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||Biomarker: EGFR/HER1|Wilcoxon signed rank test|||||||0.10
71068489|NCT00526669|141645827|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||Biomarker: HER2|Wilcoxon signed rank test|||||||0.26
71068490|NCT00526669|141645827|SUPERIORITY_OR_OTHER|||||||0.38||95.0||||Biomarker: HER3|Wilcoxon signed rank test|||||||0.38
71068491|NCT00526669|141645828|SUPERIORITY_OR_OTHER||percentage of participants|17.9|||||TWO_SIDED|95.0|9.6|29.2|||||The estimated value represents the percentage of participants with complete response or partial response.|||29.2|9.6|
71068492|NCT00526669|141645829|SUPERIORITY_OR_OTHER||percentage of participants|29.0|||||TWO_SIDED|95.0|17.9|40.3|||||The estimated value reflects the percentage of participants who achieved progression-free survival.|||40.3|17.9|
71068493|NCT04259424|141645853|OTHER|||||||0.15|||||||t-test, 2 sided|||||||.15
71068494|NCT01893281|141645886|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71068495|NCT04016779|141645929|SUPERIORITY||Least Squares Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|1.28||0.004|TWO_SIDED|95.0|-6.2|-1.2|||Mixed Model for Repeated Measures|||||-1.2|-6.2|0.0040
71112650|NCT00803361|141732295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.076|TWO_SIDED|95.0|-1.29|0.06||p-value is for symptoms have disrupted your work/schoolwork - change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.06|-1.29|0.076
71112651|NCT00803361|141732295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.14|TWO_SIDED|95.0|-1.16|0.17||p-value is for symptoms disrupted social/leisure - change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.17|-1.16|0.140
71112652|NCT00803361|141732295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.087|TWO_SIDED|95.0|-1.14|0.08||p-value is for symptoms disrupted family life - change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.08|-1.14|0.087
71112653|NCT00803361|141732295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.62||||0.083|TWO_SIDED|95.0|-3.46|0.21||p-value is for Global Functional Impairment Total Score - change|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.21|-3.46|0.083
71112654|NCT00803361|141732296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.32||||0.063|TWO_SIDED|95.0|-10.93|0.3||p-value is for Severity of Overall Pain, Past Week, Change|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline||||0.30|-10.93|0.063
71112655|NCT00803361|141732296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.66|TWO_SIDED|95.0|-6.64|4.22||p-value is for Severity of Headaches, Past Week, Change.|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline||||4.22|-6.64|0.660
71112656|NCT00803361|141732296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.03||||0.025|TWO_SIDED|95.0|-11.3|-0.76||p-value is for Severity of Back Pain, Past Week, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-0.76|-11.30|0.025
71112657|NCT00803361|141732296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.93||||0.26|TWO_SIDED|95.0|-8.06|2.19||p-value is for Severity of Shoulder Pain, Past Week, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||2.19|-8.06|0.260
71112658|NCT00803361|141732296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.67||||0.145|TWO_SIDED|95.0|-8.61|1.28||p-value is for Pain Interference, Daily Activities, Change|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||1.28|-8.61|0.145
71112659|NCT00803361|141732296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.15||||0.011|TWO_SIDED|95.0|-12.64|-1.66||p-value is for Pain During Waking Hours, Past Week, Change|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-1.66|-12.64|0.011
71112660|NCT00803361|141732297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.068|TWO_SIDED|95.0|-1.72|0.06||p-value is for Change from Baseline|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.06|-1.72|0.068
71112661|NCT02674464|141732335|SUPERIORITY||Odds Ratio (OR)|0.9||||0.68|TWO_SIDED|95.0|0.62|1.3||The a priori threshold for statistical significance was \<0.05.|Generalized Estimating Equations (GEE)|Assuming an exchangeable correlation structure|CC/SC arm compared to the SCP arm.|||1.30|0.62|0.68
71112662|NCT02674464|141732336|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.6|TWO_SIDED|95.0|-1.32|2.3||The a priori threshold for statistical significance was \<0.05.|Mixed Effects Regression||CC/SC arm was compared to the SCP arm.|||2.30|-1.32|0.60
71068496|NCT04016779|141645930|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.0023|TWO_SIDED|95.0|-0.7|-0.2|||Mixed Model for Repeated Measures|||||-0.2|-0.7|0.0023
71068497|NCT04016779|141645931|SUPERIORITY||Difference in percentage of responders|5.6||||0.303|TWO_SIDED|95.0|-5.0|16.1|||Pearson's chi-squared test|||||16.1|-5.0|0.3030
71068498|NCT04016779|141645932|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0076|TWO_SIDED|95.0|-0.6|-0.1|||Mixed Model for Repeated Measures|||||-0.1|-0.6|0.0076
71068499|NCT04016779|141645933|SUPERIORITY||Difference in percentage of responders|10.7||||0.0744|TWO_SIDED|95.0|-1.0|22.1|||Pearson's chi-squared test|||||22.1|-1.0|0.0744
71068500|NCT04016779|141645934|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.43||0.9205|TWO_SIDED|95.0|-0.9|0.8|||Mixed Model for Repeated Measures|||||0.8|-0.9|0.9205
71068501|NCT04016779|141645935|SUPERIORITY||Least Squares Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.77||0.0015|TWO_SIDED|95.0|-4.0|-0.9|||Mixed Model for Repeated Measures|||||-0.9|-4.0|0.0015
71068502|NCT04016779|141645936|SUPERIORITY||Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.66||0.038|TWO_SIDED|95.0|-2.7|-0.1|||Mixed Model for Repeated Measures|||||-0.1|-2.7|0.0380
71068503|NCT04016779|141645937|SUPERIORITY||Difference in percentage of responders|12.4||||0.0395|TWO_SIDED|95.0|0.6|23.8|||Pearson's chi-squared test|||||23.8|0.6|0.0395
71068504|NCT04016779|141645938|SUPERIORITY||Difference in percentage of responders|6.4||||0.2736|TWO_SIDED|95.0|-5.0|17.5|||Pearson's chi-squared test|||||17.5|-5.0|0.2736
71112663|NCT02674464|141732337|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.38|TWO_SIDED|95.0|-1.04|2.71||The a priori threshold for statistical significance was \<0.05.|Mixed Effects Regression|||||2.71|-1.04|0.38
71112664|NCT02674464|141732338|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.05|TWO_SIDED|95.0|-2.43|0.01||The a priori threshold for statistical significance was \<0.05.|Mixed Effects Regression||CC/SC arm compared to SCP arm.|||0.01|-2.43|0.05
71112665|NCT01262638|141732371|SUPERIORITY||Difference in Least Squares Means|-15.7|||<|0.0001|TWO_SIDED|95.0|-21.8|-9.7|||ANCOVA|||||-9.7|-21.8|<0.0001
71112666|NCT01262638|141732371|SUPERIORITY||Difference in Least Squares Means|-22.9|||<|0.0001|TWO_SIDED|95.0|-28.9|-16.9|||ANCOVA|||||-16.9|-28.9|<0.0001
71068505|NCT04016779|141645939|SUPERIORITY||Least Square Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.22||0.0468|TWO_SIDED|95.0|-4.8|0.0|||ANCOVA|||||0.0|-4.8|0.0468
71068506|NCT04016779|141645940|SUPERIORITY||Least Square Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.04||0.4462|TWO_SIDED|95.0|-2.8|1.3|||ANCOVA|||||1.3|-2.8|0.4462
71068507|NCT04016779|141645941|SUPERIORITY||Least Square Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|1.29||0.01|TWO_SIDED|95.0|-5.9|-0.8|||ANCOVA|||||-0.8|-5.9|0.0100
71068508|NCT04016779|141645942|SUPERIORITY||Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|1.16||0.2186|TWO_SIDED|95.0|-3.7|0.9|||ANCOVA|||||0.9|-3.7|0.2186
71068509|NCT04016779|141645943|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.1||0.0344|TWO_SIDED|95.0|-4.5|-0.2|||ANCOVA|||||-0.2|-4.5|0.0344
71068510|NCT04016779|141645944|SUPERIORITY||Least Square Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.99||0.368|TWO_SIDED|95.0|-1.1|2.8|||ANCOVA|||||2.8|-1.1|0.3680
70852772|NCT01578850|141194348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.21||||0.078|TWO_SIDED|95.0|-8.91|0.48|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||General Health VAS: Week 28||0.48|-8.91|0.078
71068511|NCT04016779|141645945|SUPERIORITY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.1||0.6361|TWO_SIDED|95.0|-2.7|1.6|||ANCOVA|||||1.6|-2.7|0.6361
71068512|NCT04016779|141645946|SUPERIORITY||Least Square Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|1.2||0.1708|TWO_SIDED|95.0|-4.0|0.7|||ANCOVA|||||0.7|-4.0|0.1708
71068513|NCT04016779|141645947|SUPERIORITY||Least Square Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.3||0.0094|TWO_SIDED|95.0|-6.0|-0.8|||ANCOVA|||||-0.8|-6.0|0.0094
71068514|NCT04016779|141645948|SUPERIORITY||Least Square Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.34||0.0104|TWO_SIDED|95.0|-6.1|-0.8|||ANCOVA|||||-0.8|-6.1|0.0104
71068515|NCT04016779|141645949|SUPERIORITY||Least Square Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|1.13||0.0178|TWO_SIDED|95.0|-4.9|-0.5|||ANCOVA|||||-0.5|-4.9|0.0178
71068516|NCT04016779|141645950|SUPERIORITY||Least Square Mean Difference|-3.2|STANDARD_ERROR_OF_MEAN|1.34||0.0187|TWO_SIDED|95.0|-5.8|-0.5|||ANCOVA|||||-0.5|-5.8|0.0187
71068517|NCT00910208|141645951|SUPERIORITY|||||||0.82|||||||ANOVA|||||||0.82
71068518|NCT00910208|141645952|SUPERIORITY|||||||0.47|||||||Chi-squared|||||||0.47
71068519|NCT00910208|141645953|SUPERIORITY|||||||0.06|||||||ANOVA|||||||0.06
71068520|NCT00910208|141645954|SUPERIORITY|||||||0.033|||||||Chi-squared|||||||0.033
71068521|NCT00910208|141645955|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
71068522|NCT00910208|141645956|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71068523|NCT02295020|141645957|SUPERIORITY_OR_OTHER|||||||0.181|||||||t-test, 2 sided|||||||0.181
71068524|NCT02295020|141645958|SUPERIORITY_OR_OTHER|||||||0.232|||||||t-test, 2 sided|||||||0.232
71112667|NCT01262638|141732371|SUPERIORITY||Difference in Least Squares Means|-24.5|||<|0.0001|TWO_SIDED|95.0|-30.5|-18.4|||ANCOVA|||||-18.4|-30.5|<0.0001
71112668|NCT00894699|141732389|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
71112669|NCT00894699|141732389|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71112670|NCT02091362|141732436|SUPERIORITY_OR_OTHER||LS Mean Difference|2.26|||<|0.001|TWO_SIDED|95.0|1.11|3.4|||Mixed Models Analysis|||||3.40|1.11|<.001
71112671|NCT02091362|141732437|SUPERIORITY_OR_OTHER||LS Mean Difference|1.37|||<|0.01|TWO_SIDED|95.0|0.66|2.08|||Mixed Models Analysis|||||2.08|0.66|<0.01
71068525|NCT02295020|141645959|SUPERIORITY_OR_OTHER|||||||0.311|||||||t-test, 2 sided|||||||0.311
71068526|NCT02295020|141645961|SUPERIORITY_OR_OTHER|||||||0.449|||||||t-test, 2 sided|||||||0.449
71068527|NCT02295020|141645962|SUPERIORITY_OR_OTHER|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||||||0.860
71068528|NCT02295020|141645963|SUPERIORITY_OR_OTHER|||||||0.735|||||||Wilcoxon (Mann-Whitney)|||||||0.735
71068529|NCT02295020|141645964|SUPERIORITY_OR_OTHER|||||||0.479|||||||Wilcoxon (Mann-Whitney)|||||||0.479
71068530|NCT02295020|141645965|SUPERIORITY_OR_OTHER|||||||0.323|||||||Wilcoxon (Mann-Whitney)|||||||0.323
71068531|NCT02295020|141645966|SUPERIORITY_OR_OTHER|||||||0.878|||||||Wilcoxon (Mann-Whitney)|||||||0.878
71068532|NCT00355147|141645976|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.69|TWO_SIDED||||||Mixed Models Analysis|Adjusted for site, strata, baseline score, randomized group, month and the group by month interaction|This score represents change from baseline to six months across the groups.|This is an analysis of the outcome, Stroke Specific Quality of Life Overall Total Score.||||0.69
71068533|NCT00355147|141645976|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.47|STANDARD_ERROR_OF_MEAN|0.23||0.05|TWO_SIDED|||||Adjusted for site, strata, baseline value, treatment group, month of assessment, treatment group x month, random subject effect|Mixed Models Analysis||This score represents change from baseline to three months across groups.|This is an analysis of the Perceived Energy Domain within the Stroke Specific Quality of Life Measure||||0.05
71068534|NCT00355147|141645977|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12||||0.66|TWO_SIDED||||||Mixed Models Analysis|Adjusted by site, strata, baseline score, treatment group, month and group by month interaction|The score is the change from baseline to six months between groups.|||||0.66
71068535|NCT00355147|141645978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.74||||0.06|TWO_SIDED|95.0|0.88|51.31|||Regression, Logistic|||||51.31|0.88|0.06
71068536|NCT00355147|141645978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.45||||0.036|TWO_SIDED|95.0|1.08|10.96|||Regression, Logistic|||Within group Intervention Pre Post Comparison Compliance with Diabetes Medication||10.96|1.08|0.036
71068537|NCT00355147|141645978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.51||||0.407|TWO_SIDED|95.0|0.1|2.7|||Regression, Logistic|||Within Group attention control group intervention pre post comparison compliance with Diabetes Medication||2.70|0.10|0.407
71068538|NCT00355147|141645979|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.05|TWO_SIDED|95.0|0.54|4.48|||Regression, Logistic|||Between Group Intervention Pre Post Comparison Compliance with Statin Medication||4.48|0.54|0.05
71068539|NCT00355147|141645979|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.98||||0.0001|TWO_SIDED|95.0|2.81|12.76|||Regression, Logistic|||Within Group Intervention Pre Post Comparison Compliance with Statin Medication||12.76|2.81|0.0001
71112672|NCT05319899|141732448|OTHER||Geometric Mean Ratio (%)|140.63|||||TWO_SIDED|90.0|118.94|166.26||||||Analysis was performed using analysis of variance (ANOVA).||166.26|118.94|
71112673|NCT05319899|141732448|OTHER||Geometric Mean Ratio (%)|77.65|||||TWO_SIDED|90.0|65.67|91.8||||||Analysis was performed using ANOVA.||91.80|65.67|
71112674|NCT05319899|141732449|OTHER||Geometric Mean Ratio (%)|128.23|||||TWO_SIDED|90.0|112.99|145.52||||||Analysis was performed using ANOVA.||145.52|112.99|
71112675|NCT05319899|141732449|OTHER||Geometric Mean Ratio (%)|95.94|||||TWO_SIDED|90.0|84.54|108.88||||||Analysis was performed using ANOVA.||108.88|84.54|
71112676|NCT00191945|141732561|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.9|STANDARD_ERROR_OF_MEAN|1.6|<|0.001||95.0|-11.0|-4.8|||Mixed Models Analysis|Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.|Least Squares Mean difference at week 12 (Atomoxetine minus Placebo)|||-4.8|-11.0|<0.001
71068540|NCT00355147|141645979|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.83||||0.0004|TWO_SIDED|95.0|1.83|8.01|||Regression, Logistic|||Within Group Attention Control Pre Post Comparison Compliance with Statin Medication.||8.01|1.83|0.0004
71068541|NCT00355147|141645980|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.34||||0.096|TWO_SIDED|95.0|0.86|6.4|||Regression, Logistic|||Between Group Intervention Pre Post Comparison Compliance with Hypertension Medication||6.40|0.86|0.096
71068542|NCT00355147|141645980|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.68||||0.0004|TWO_SIDED|95.0|1.81|7.48|||Regression, Logistic|||Within Group Intervention Pre Post Comparison Compliance with Hypertension Medication||7.48|1.81|0.0004
71068543|NCT00355147|141645980|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57||||0.21|TWO_SIDED|95.0|0.77|3.21|||Regression, Logistic|||Within Group Attention Group Pre Post Comparison Compliance with Hypertension Medication.||3.21|0.77|0.21
71068544|NCT03514485|141646013|SUPERIORITY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.34|0.25||||||Linear mixed effects models were then used to make the comparisons of all combinations of primary care and school-based interventions with respect to Asthma Control. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.25|-0.34|
71068545|NCT03514485|141646013|SUPERIORITY||Mean Difference (Final Values)|-0.08|||||TWO_SIDED|95.0|-0.34|0.18||||||Linear mixed effects models were then used to make the comparisons of all combinations of primary care and school-based interventions with respect to Asthma Control. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the COVID-19 pandemic.||0.18|-0.34|
71068546|NCT03514485|141646013|SUPERIORITY||Mean Difference (Final Values)|-0.22|||||TWO_SIDED|95.0|-0.48|0.04||||||Linear mixed effects models were then used to make the comparisons of all combinations of primary care and school-based interventions with respect to Asthma Control. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the COVID-19 pandemic.||0.04|-0.48|
71079080|NCT00978341|141666053|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.072||0.3159||95.0|-0.09|0.24|||ANOVA|||Difference from placebo (including Baseline); Day 8: 4 hours post-dose.||0.24|-0.09|0.3159
71079081|NCT00978341|141666053|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.103||0.8203||95.0|-0.22|0.27|||ANOVA|||Difference from placebo (including Baseline); Day 8: 6 hours post-dose.||0.27|-0.22|0.8203
71079082|NCT03035916|141666056|OTHER|||||||0.454|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."||||0.454
71079083|NCT03035916|141666056|OTHER|||||||0.402|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."||||0.402
71079084|NCT03035916|141666056|OTHER|||||||0.901|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."||||0.901
71079085|NCT03035916|141666056|OTHER|||||||0.54|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."||||0.540
71079086|NCT03035916|141666056|OTHER|||||||0.523|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."||||0.523
71079087|NCT03035916|141666056|OTHER|||||||0.26|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."||||0.260
71079088|NCT03035916|141666056|OTHER|||||||0.139|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."||||0.139
71079089|NCT03035916|141666056|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."||||0.001
71079090|NCT03035916|141666056|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."||||0.001
71079091|NCT03035916|141666056|OTHER|||||||0.464|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."||||0.464
71079092|NCT03035916|141666056|OTHER|||||||0.007|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."||||0.007
71079093|NCT03035916|141666056|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."||||0.001
71028419|NCT00721409|141564208|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.299|||<|0.0001|TWO_SIDED|95.0|0.156|0.572||1-sided p-value is from unstratified log-rank test (α=0.10).|Log Rank|||Unstratified analysis was presented above. Kaplan-Meier method was applied for median and 95% CI.||0.572|0.156|<0.0001
71028420|NCT00721409|141564208|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.486||||0.003|TWO_SIDED|95.0|0.288|0.822||1-sided p-value is from unstratified log-rank test (α=0.10).|Log Rank|||Unstratified analysis was presented above. Kaplan-Meier method was applied for median and 95% CI.||0.822|0.288|0.0030
71028421|NCT00721409|141564209|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.69|TWO_SIDED|95.0|-0.7|1.0||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Severity Scale.||1.0|-0.7|0.6900
71028422|NCT00721409|141564209|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.7125|TWO_SIDED|95.0|-1.8|1.2||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Severity Scale.||1.2|-1.8|0.7125
71028423|NCT00721409|141564209|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5||||0.4012|TWO_SIDED|95.0|-0.6|1.5||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Severity Scale.||1.5|-0.6|0.4012
71028424|NCT00721409|141564210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.3346|TWO_SIDED|95.0|-0.5|1.3||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Interference Scale.||1.3|-0.5|0.3346
71028425|NCT00721409|141564210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.563|TWO_SIDED|95.0|-1.0|1.9||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Interference Scale.||1.9|-1.0|0.5630
71028426|NCT00721409|141564210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5||||0.4427|TWO_SIDED|95.0|-0.7|1.6||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Severity Scale.||1.6|-0.7|0.4427
71028427|NCT00818883|141564290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6|||<|0.001|TWO_SIDED|95.0|-8.3|-2.9||Overall type I error rate controlled using stepwise testing procedure. First treatment test done at Week 6. If statistically significant at significance level of 5%, then treatment comparison at Week 10 was performed. Tested at 5% significance level.|ANCOVA|||Analysis of Covariance (ANCOVA) model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.||-2.9|-8.3|<0.001
71028428|NCT00818883|141564290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.0|||<|0.001||95.0|-7.5|-2.5||Overall type I error rate controlled using stepwise testing procedure. First treatment test done at Week 6. If statistically significant at significance level of 5%, then treatment comparison at Week 10 was performed. Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.||-2.5|-7.5|<0.001
71028429|NCT00818883|141564291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7|||<|0.001|TWO_SIDED|95.0|-5.2|-2.2||Overall type I error rate controlled using stepwise testing procedure. First treatment test done at Week 6. If statistically significant at significance level of 5%, then treatment comparison at Week 10 was performed. Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.||-2.2|-5.2|<0.001
71028430|NCT00818883|141564291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|||<|0.001|TWO_SIDED|95.0|-4.1|-1.3||Overall type I error rate controlled using stepwise testing procedure. First treatment test done at Week 6. If statistically significant at significance level of 5%, then treatment comparison at Week 10 was performed. Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.||-1.3|-4.1|<0.001
71028431|NCT00818883|141564292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.3|||<|0.001|TWO_SIDED|95.0|-10.5|-4.2||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.||-4.2|-10.5|<0.001
71028432|NCT00818883|141564292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2||||0.001|TWO_SIDED|95.0|-6.8|-1.7||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.||-1.7|-6.8|0.001
71028433|NCT00818883|141564293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3|||<|0.001|TWO_SIDED|95.0|-6.3|-2.3||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.||-2.3|-6.3|<0.001
71028434|NCT00818883|141564293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.006|TWO_SIDED|95.0|-4.2|-0.7||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.||-0.7|-4.2|0.006
71028435|NCT00818883|141564294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.8|||<|0.001|TWO_SIDED|95.0|-8.4|-3.2||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.||-3.2|-8.4|<0.001
71028436|NCT00818883|141564294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2|||<|0.001|TWO_SIDED|95.0|-6.4|-2.0||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.||-2.0|-6.4|<0.001
71028437|NCT00818883|141564295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8|||<|0.001|TWO_SIDED|95.0|-5.5|-2.1||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.||-2.1|-5.5|<0.001
71028438|NCT00818883|141564295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6|||<|0.001|TWO_SIDED|95.0|-4.1|-1.1||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.||-1.1|-4.1|<0.001
71112677|NCT00191945|141732562|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.5|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-9.5|-3.6|||Mixed Models Analysis|Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.|Least Squares Mean difference at Week 9 (Atomoxetine - Placebo)|A gatekeeper strategy was employed for sequentially testing the secondary hypotheses using a REML-based Mixed-Model Repeated Measures (MMRM) technique as defined for the primary efficacy analyses. If primary hypothesis is significant at 0.05 (2-sided), first secondary hypothesis will be tested at Visit 6 from MMRM. If comparison is significant, subsequent secondary hypotheses will be tested in sequence until first null hypothesis fails to be rejected.||-3.6|-9.5|<0.001
71112678|NCT00191945|141732563|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.2|STANDARD_ERROR_OF_MEAN|1.5||0.0009||95.0|-8.2|-2.2|||Mixed Models Analysis|Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.|Least Squares Mean difference at 6 weeks (Atomoxetine - Placebo)|A gatekeeper strategy was employed for sequentially testing the secondary hypotheses using a REML-based Mixed-Model Repeated Measures (MMRM) technique as defined for the primary efficacy analyses. If primary hypothesis is significant at 0.05 (2-sided), first secondary hypothesis will be tested at Visit 6 from MMRM. If comparison is significant, subsequent secondary hypotheses will be tested in sequence until first null hypothesis fails to be rejected.||-2.2|-8.2|0.0009
71112679|NCT00191945|141732564|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.8|STANDARD_ERROR_OF_MEAN|1.3||0.0033||95.0|-6.4|-1.3|||Mixed Models Analysis|Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.|Least Squares Mean difference at 4 weeks (Atomoxetine - Placebo)|A gatekeeper strategy was employed for sequentially testing the secondary hypotheses using a REML-based Mixed-Model Repeated Measures (MMRM) technique as defined for the primary efficacy analyses. If primary hypothesis is significant at 0.05 (2-sided), first secondary hypothesis will be tested at Visit 6 from MMRM. If comparison is significant, subsequent secondary hypotheses will be tested in sequence until first null hypothesis fails to be rejected.||-1.3|-6.4|0.0033
70852773|NCT01578850|141194348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.54||||0.003|TWO_SIDED|95.0|-12.49|-2.59|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||General Health VAS: Week 36||-2.59|-12.49|0.003
71112680|NCT00191945|141732565|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7|STANDARD_ERROR_OF_MEAN|1.1||0.013||95.0|-4.9|-0.6||P-value is for the difference between groups in the change from 12 weeks minus 6 weeks.|Mixed Models Analysis|Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.|Least Squares Mean difference between groups (Atomoxetine - Placebo) in change from 6 weeks to 12 weeks|A gatekeeper strategy was employed for sequentially testing the secondary hypotheses using a REML-based Mixed-Model Repeated Measures (MMRM) technique as defined for the primary efficacy analyses. If primary hypothesis is significant at 0.05 (2-sided), first secondary hypothesis will be tested at Visit 6 from MMRM. If comparison is significant, subsequent secondary hypotheses will be tested in sequence until first null hypothesis fails to be rejected.||-0.6|-4.9|0.013
71068547|NCT03514485|141646013|SUPERIORITY||Mean Difference (Final Values)|-0.18|||||TWO_SIDED|95.0|-0.44|0.9||||||Linear mixed effects models were then used to make the comparisons of all combinations of primary care and school-based interventions with respect to Asthma Control. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the COVID-19 pandemic.||0.9|-0.44|
71068548|NCT03514485|141646013|SUPERIORITY||Mean Difference (Final Values)|-0.14|||||TWO_SIDED|95.0|-0.36|0.09||||||Linear mixed effects models were then used to make the comparisons of all combinations of primary care and school-based interventions with respect to Asthma Control. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the COVID-19 pandemic.||0.09|-0.36|
71068549|NCT03514485|141646014|SUPERIORITY||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-0.39|0.55||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Daytime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.55|-0.39|
71068550|NCT03514485|141646014|SUPERIORITY||Mean Difference (Net)|0.46|||||TWO_SIDED|95.0|0.04|0.88||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Daytime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.88|0.04|
71112681|NCT00191945|141732568|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.7|STANDARD_ERROR_OF_MEAN|2.3|<|0.001||95.0|-15.1|-6.2||P-value is for the difference between groups in the change from 12 weeks minus baseline.|Mixed Models Analysis|mixed model repeated measures analyis: treatment, visit, patient, and CPRS-R: S Total score at baseline as covariate, with treatment\*visit interaction|Least Squares Mean difference between groups (Atomoxetine - Placebo) in change from baseline to 12 weeks.|||-6.2|-15.1|<0.001
71112682|NCT00191945|141732569|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.47||||0.81||95.0|-3.39|4.33||P-value for Parent: Satisfaction difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||4.33|-3.39|0.810
71112683|NCT00191945|141732569|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.96||||0.243||95.0|-1.35|5.29||P-value for Parent: Comfort difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||5.29|-1.35|0.243
71068551|NCT03514485|141646014|SUPERIORITY||Mean Difference (Net)|-0.65|||||TWO_SIDED|95.0|-1.06|-0.23||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Daytime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||-0.23|-1.06|
71068552|NCT03514485|141646014|SUPERIORITY||Mean Difference (Net)|-1.03|||||TWO_SIDED|95.0|-1.39|-0.67||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Daytime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||-0.67|-1.39|
71068553|NCT03514485|141646014|SUPERIORITY||Mean Difference (Net)|-0.57|||||TWO_SIDED|95.0|-0.95|-0.18||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Daytime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||-0.18|-0.95|
71068554|NCT03514485|141646015|SUPERIORITY||Mean Difference (Net)|-0.13|||||TWO_SIDED|95.0|-0.53|0.28||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Nighttime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.28|-0.53|
71068555|NCT03514485|141646015|SUPERIORITY||Median Difference (Net)|-0.09|||||TWO_SIDED|95.0|-0.45|0.26||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Nighttime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.26|-0.45|
71068556|NCT03514485|141646015|SUPERIORITY||Mean Difference (Net)|-0.25|||||TWO_SIDED|95.0|-0.6|0.1||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Nighttime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.10|-0.60|
71068557|NCT03514485|141646015|SUPERIORITY||Median Difference (Net)|-0.28|||||TWO_SIDED|95.0|-0.57|0.01||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Nighttime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.01|-0.57|
71068558|NCT03514485|141646015|SUPERIORITY||Mean Difference (Net)|-0.38|||||TWO_SIDED|95.0|-0.72|-0.04||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Nighttime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||-0.04|-0.72|
71068559|NCT03514485|141646016|SUPERIORITY||Mean Difference (Net)|2.38|||||TWO_SIDED|95.0|0.58|4.19||||||Mixed-effects generalized linear model with binomial family (n=number of school-days \[varies per child\]) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to school absences. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||4.19|0.58|
71068560|NCT03514485|141646016|SUPERIORITY||Mean Difference (Net)|4.49|||||TWO_SIDED|95.0|2.54|6.43||||||Mixed-effects generalized linear model with binomial family (n=number of school-days \[varies per child\]) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to school absences. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||6.43|2.54|
71068561|NCT03514485|141646016|SUPERIORITY||Mean Difference (Net)|-0.97|||||TWO_SIDED|95.0|-2.78|0.84||||||Mixed-effects generalized linear model with binomial family (n=number of school-days \[varies per child\]) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to school absences. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.84|-2.78|
71068562|NCT03514485|141646016|SUPERIORITY||Mean Difference (Net)|-3.07|||||TWO_SIDED|95.0|-5.03|-1.12||||||Mixed-effects generalized linear model with binomial family (n=number of school-days \[varies per child\]) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to school absences. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||-1.12|-5.03|
71068563|NCT03514485|141646016|SUPERIORITY||Mean Difference (Net)|1.41|||||TWO_SIDED|95.0|-0.48|3.31||||||Mixed-effects generalized linear model with binomial family (n=number of school-days \[varies per child\]) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to school absences. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||3.31|-0.48|
71068564|NCT03514485|141646017|SUPERIORITY||Mean Difference (Net)|0.17|||||TWO_SIDED|95.0|-0.19|0.54||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of ED visits. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.54|-0.19|
71068565|NCT03514485|141646017|SUPERIORITY||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.28|0.35||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of ED visits. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.35|-0.28|
71068566|NCT03514485|141646017|SUPERIORITY||Mean Difference (Net)|-0.34|||||TWO_SIDED|95.0|-0.68|-0.01||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of ED visits. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||-0.01|-0.68|
71068567|NCT03514485|141646017|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.48|0.08||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of ED visits. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.08|-0.48|
71068568|NCT03514485|141646017|SUPERIORITY||Mean Difference (Net)|-0.17|||||TWO_SIDED|95.0|-0.48|0.14||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of ED visits. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.14|-0.48|
71068569|NCT03514485|141646018|SUPERIORITY||Mean Difference (Net)|0.09|||||TWO_SIDED|95.0|-0.11|0.29||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of hospitalizations. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.29|-0.11|
71068570|NCT03514485|141646018|SUPERIORITY||Mean Difference (Net)|0.16|||||TWO_SIDED|95.0|-0.03|0.34||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of hospitalizations. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.34|-0.03|
71068571|NCT03514485|141646018|SUPERIORITY||Mean Difference (Net)|-0.001|||||TWO_SIDED|95.0|-0.19|0.18||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of hospitalizations. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.18|-0.19|
71068572|NCT03514485|141646018|SUPERIORITY||Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-0.23|0.09||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of hospitalizations. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.09|-0.23|
71068573|NCT03514485|141646018|SUPERIORITY||Mean Difference (Net)|0.09|||||TWO_SIDED|95.0|-0.09|0.26||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of hospitalizations. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.26|-0.09|
71068574|NCT03514485|141646019|SUPERIORITY||Mean Difference (Net)|0.32|||||TWO_SIDED|95.0|0.0|0.65||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL emotional functioning domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.65|0.00|
71068575|NCT03514485|141646019|SUPERIORITY||Mean Difference (Net)|0.16|||||TWO_SIDED|95.0|-0.12|0.45||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL emotional functioning domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.45|-0.12|
71068576|NCT03514485|141646019|SUPERIORITY||Mean Difference (Net)|-0.11|||||TWO_SIDED|95.0|-0.4|0.18||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL emotional functioning domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.18|-0.40|
71068577|NCT03514485|141646019|SUPERIORITY||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-0.2|0.29||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL emotional functioning domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.29|-0.20|
71068578|NCT03514485|141646019|SUPERIORITY||Mean Difference (Net)|0.21|||||TWO_SIDED|95.0|-0.08|0.5||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL emotional functioning domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.50|-0.08|
71079094|NCT03035916|141666056|OTHER|||||||0.411|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."||||0.411
71068579|NCT03514485|141646020|SUPERIORITY||Mean Difference (Net)|0.25|||||TWO_SIDED|95.0|-0.19|0.69||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL activity limitations domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.69|-0.19|
71068580|NCT03514485|141646020|SUPERIORITY||Mean Difference (Net)|0.25|||||TWO_SIDED|95.0|-0.14|0.63||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL activity limitations domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.63|-0.14|
71068581|NCT03514485|141646020|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.49|0.3||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL activity limitations domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.30|-0.49|
71068582|NCT03514485|141646020|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.43|0.24||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL activity limitations domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.24|-0.43|
71068583|NCT03514485|141646020|SUPERIORITY||Mean Difference (Net)|0.15|||||TWO_SIDED|95.0|-0.24|0.54||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL activity limitations domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.54|-0.24|
71068584|NCT00791661|141646025|SUPERIORITY_OR_OTHER||Geometric mean ratio (fed/fasted)|0.92||||||95.0|||||Mixed-effect model|Based on mixed effect model with panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.||||||
71068585|NCT00791661|141646027|SUPERIORITY_OR_OTHER||Geometric mean ratio (fed/fasted)|0.81||||||95.0|||||Mixed-effect model|Based on mixed effect model with panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.||||||
71068586|NCT00791661|141646031|SUPERIORITY_OR_OTHER||Difference in least squares mean|-8.1||||0.368|TWO_SIDED|90.0|-23.0|6.8||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 15 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||6.8|-23.0|0.368
71068587|NCT00791661|141646031|SUPERIORITY_OR_OTHER||Difference in least squares mean|-16.6||||0.079|TWO_SIDED|90.0|-32.2|-1.1||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 30 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-1.1|-32.2|0.079
71068588|NCT00791661|141646031|SUPERIORITY_OR_OTHER||Difference in least squares mean|-25.7||||0.007|TWO_SIDED|90.0|-40.9|-10.5||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 45 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-10.5|-40.9|0.007
71078610|NCT01441245|141665092|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.|||||<|0.01|TWO_SIDED||||||Chi-squared|||Qualitative variables are expressed as percentage of partecipants and compared with chi-square test. p-value equal or lower than 0.05 are considered statistically significant.||||<0.01
71078611|NCT02085070|141665126|SUPERIORITY|A response of \> 10% of patients was defined as superior.|% response|29.7|||||TWO_SIDED|95.0|15.9|47.0||||||Each group was assessed individually. The primary goal of this study is to determine the efficacy of MK-3475 in patients with untreated brain metastases from NSCLC. The primary endpoint is the brain metastasis response rate (BMRR). A drug with minimal activity would be expected to have a BMRR of 10%.||47.0|15.9|
71078612|NCT02085070|141665126|SUPERIORITY|A response of \> 10% of patients was defined as superior.|% of patients|26.0|||||TWO_SIDED|95.0|10.0|48.0||||||Each group was assessed individually. The primary goal of this study is to determine the efficacy of MK-3475 in patients with untreated brain metastases from melanoma. The primary endpoint is the brain metastasis response rate (BMRR). A drug with minimal activity would be expected to have a BMRR of 10%.||48.0|10.0|
71078613|NCT02769312|141665128|OTHER||Effect size (cohen's d)|0.16||||0.46|TWO_SIDED||||||ANCOVA|||||||0.46
71078614|NCT02769312|141665129|SUPERIORITY||Effect size (cohen's d)|0.12||||0.61|TWO_SIDED||||||ANCOVA|||||||0.61
71078615|NCT02769312|141665130|SUPERIORITY||Effect size (cohen's d)|0.39||||0.04|TWO_SIDED||||||ANCOVA|||||||.04
71078616|NCT02178358|141665131|SUPERIORITY||Hazard Ratio (HR)|0.776||||0.837|TWO_SIDED|95.0|0.434|1.226|||Bayesian exponential-likelihood model|||||1.226|0.434|0.837
71078617|NCT02178358|141665131|SUPERIORITY||Hazard Ratio (HR)|0.917||||0.704|TWO_SIDED|95.0|0.633|1.266|||Bayesian exponential-likelihood model|||||1.266|0.633|0.704
71028439|NCT00048048|141564307|SUPERIORITY_OR_OTHER||Least square mean|0.979|STANDARD_ERROR_OF_MEAN|0.223|||TWO_SIDED|95.0|0.534|1.425|||||To analyze the appropriateness of the chosen conversion factors, a second regression analysis was carried out. This regression was on the three conversion factor dose groups, using the regression slope estimates of Hb. This was not pre-specified.|All cohorts with dosing frequency 1X/ Week||1.425|0.534|
71078618|NCT02756819|141665152|OTHER||||||<|0.001||||||P-value was reported for Change at Month 6 relative to Baseline.|Wilcoxon test|||||||<0.001
71078619|NCT02756819|141665153|OTHER||||||<|0.001||||||P-value was reported for Change at Month 6 relative to Baseline.|Wilcoxon test|||||||<0.001
71028440|NCT00048048|141564307|SUPERIORITY_OR_OTHER||Least square mean|0.851|STANDARD_ERROR_OF_MEAN|0.228|||TWO_SIDED|95.0|0.395|1.307|||||To analyze the appropriateness of the chosen conversion factors, a second regression analysis was carried out. This regression was on the three conversion factor dose groups, using the regression slope estimates of Hb. This was not pre-specified.|All cohorts with dosing frequency 1X/ 2Week||1.307|0.395|
71028441|NCT00048048|141564307|SUPERIORITY_OR_OTHER||Least square mean|0.932|STANDARD_ERROR_OF_MEAN|0.222|||TWO_SIDED|95.0|0.488|1.377|||||To analyze the appropriateness of the chosen conversion factors, a second regression analysis was carried out. This regression was on the three conversion factor dose groups, using the regression slope estimates of Hb. This was not pre-specified.|All cohorts with dosing frequency 1X /3 Week||1.377|0.488|
71028442|NCT01901055|141564324|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.18||0.017|TWO_SIDED|95.0|-0.68|0.04||F-test statistics for group X time = 4.27|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|Statistical analyses were revised from the original protocol for reporting results at 24 week because unable to recruit an adequate sample size at this time point of participants originally on CPAP for 24 weeks and those who were in the original sham-CPAP group who crossed over to CPAP and completed 24 weeks of treatment.||0.04|-0.68|0.017
71028443|NCT01901055|141564325|SUPERIORITY||Mean Difference (Net)|-16.78|STANDARD_ERROR_OF_MEAN|10.99||0.307|TWO_SIDED|95.0|-38.66|5.09||F test statistics for group X time = 1.20|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||5.09|-38.66|0.307
71028444|NCT01901055|141564326|SUPERIORITY||Mean Difference (Net)|-0.25|STANDARD_ERROR_OF_MEAN|0.3||0.732|TWO_SIDED|95.0|-0.85|0.35||F test statistics for group X time = 0.31|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||0.35|-0.85|0.732
71028445|NCT01901055|141564327|SUPERIORITY||Mean Difference (Net)|3.65|STANDARD_ERROR_OF_MEAN|2.65||0.919|TWO_SIDED|95.0|-1.62|8.92||F test statistics for group X time = 0.01|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||8.92|-1.62|0.919
71028446|NCT01901055|141564328|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.54||0.125|TWO_SIDED|95.0|-1.18|0.96||F-test statistics for group X time = 2.12|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||0.96|-1.18|0.125
71028447|NCT01901055|141564329|SUPERIORITY||Mean Difference (Net)|87.22|STANDARD_ERROR_OF_MEAN|529.1||0.639|TWO_SIDED|95.0|-936.1|1137.5||F-test statistics for group X time = 0.45|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||1137.50|-936.10|0.639
71028448|NCT01901055|141564330|SUPERIORITY||Mean Difference (Net)|-0.63|STANDARD_ERROR_OF_MEAN|0.49||0.461|TWO_SIDED|95.0|-1.61|0.35||F-test statistics for group X time = 0.78|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||0.35|-1.61|0.461
71028449|NCT01901055|141564331|SUPERIORITY||Mean Difference (Net)|3.04|STANDARD_ERROR_OF_MEAN|3.94||0.776|TWO_SIDED|95.0|-4.78|10.86||F-test statistics for group X time= 0.25|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||10.86|-4.78|0.776
71028450|NCT01901055|141564332|SUPERIORITY||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.79||0.378|TWO_SIDED|95.0|-1.24|1.89||F-test statistics for group X time = 0.98|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||1.89|-1.24|0.378
71028451|NCT01901055|141564333|SUPERIORITY||Mean Difference (Net)|3.18|STANDARD_ERROR_OF_MEAN|7.24||0.213|TWO_SIDED|95.0|-11.19|17.56||F-test statistics for group X time = 1.57|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||17.56|-11.19|0.213
71028452|NCT01901055|141564334|SUPERIORITY||Mean Difference (Net)|0.006|STANDARD_ERROR_OF_MEAN|0.64||0.005|TWO_SIDED|95.0|-1.27|1.28||F-test statistics for group X time = 5.66|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||1.28|-1.27|0.005
71028453|NCT00948675|141564353|SUPERIORITY_OR_OTHER_LEGACY|||||||0.176||95.0|||||Log Rank|||||||0.176
71028454|NCT00948675|141564354|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61||95.0|||||Log Rank|||||||0.610
71028455|NCT00948675|141564355|SUPERIORITY_OR_OTHER_LEGACY|||||||0.615||95.0|||||Log Rank|||||||0.615
71028456|NCT00948675|141564356|SUPERIORITY_OR_OTHER_LEGACY|||||||0.414||95.0|||||Pearson Chi-square Test|||||||0.414
71028457|NCT00948675|141564357|SUPERIORITY_OR_OTHER_LEGACY|||||||0.575||95.0|||||Pearson Chi-square Test|||||||0.575
71028458|NCT00571428|141564391|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was defined a priori such that 90%CI for the difference between therapies had to fall entirely within +/- 0.07L.|Mean Difference (Final Values)|0.011||||||90.0|-0.015|0.037|||Mixed Models Analysis|Treatment group, treatment sequence, predose FEV1, \& Visit number are fixed effects; subject within treatment sequence is a random effect.||||0.037|-0.015|
71028459|NCT00571428|141564392|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was defined a priori such that 90%CI for the difference between therapies has to fall entirely within +/- 0.07L.|Mean Difference (Final Values)|0.062||||||90.0|0.035|0.09|||Mixed Models Analysis|Treatment group, treatment sequence, pre-dose FEV1, \& Visit Number are fixed effects; subjects within treatment sequence is a random effect.||||0.090|0.035|
71028460|NCT00571428|141564393|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was defined a priori such that 90%CI for the difference between therapies has to fall entirely within +/- 0.07L.|Median Difference (Final Values)|-0.035||||||90.0|-0.079|0.008|||Mixed Models Analysis|Treatment group, treatment sequence, pre-dose FEV1, \& Visit Number are fixed effects; subjects within treatment sequence is a random effect.||||0.008|-0.079|
71028461|NCT00571428|141564394|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was defined a priori such that 90%CI for the difference between therapies has to fall entirely within +/- 0.07L.|Median Difference (Final Values)|-0.03||||||90.0|-0.086|0.026|||Mixed Models Analysis|Treatment group, treatment sequence, pre-dose FEV1, \& Visit Number are fixed effects; subjects within treatment sequence is a random effect.||||0.026|-0.086|
71028462|NCT00571428|141564399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.694||||||90.0|0.525|2.862|||Mixed Models Analysis|Treatment group, treatment sequence, pre-dose FEV1, \& Visit number are fixed effects; subject within treatment sequence is a random effect.||||2.862|0.525|
71078620|NCT02756819|141665156|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Overweight)|Wilcoxon test|||||||<0.001
71078621|NCT02756819|141665156|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class I)|Wilcoxon test|||||||<0.001
71078622|NCT02756819|141665156|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class II)|Wilcoxon test|||||||<0.001
71078623|NCT02756819|141665156|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class III)|Wilcoxon test|||||||<0.001
71078624|NCT02756819|141665156|OTHER||||||<|0.001|||||||Wilcoxon test|P-value was reported for Change from baseline at Month 6 (Normal glucose metabolism)||||||<0.001
71078625|NCT02756819|141665156|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Impaired glucose tolerance)|Wilcoxon test|||||||<0.001
71078626|NCT02756819|141665156|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Diabetes Mellitus - No)|Wilcoxon test|||||||<0.001
71078627|NCT02756819|141665156|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Diabetes Mellitus - Yes)|Wilcoxon test|||||||<0.001
71028463|NCT00571428|141564400|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was defined a priori such that 90%CI for the difference between therapies had to fall entirely within +/- 0.07L.|Mean Difference (Final Values)|0.052||||||90.0|0.015|0.09|||Mixed Models Analysis|Treatment group, treatment sequence, pre-dose FEV1, \& Visit number are fixed effects; subject within treatment sequence is a random effect||||0.090|0.015|
71028464|NCT04087395|141564405|NON_INFERIORITY|To achieve non-inferiority, the observed p-value must be \<= 0.5 taking into account of the non-inferiority margin (i.e., 10mm difference in Pain VAS between the two treatment groups).|||||<|0.0001||||||One-sided paired student t-test|t-test, 1 sided|||||||<0.0001
71028465|NCT02796664|141564416|OTHER|Equality test||||||0.462|||||||Fisher Exact|||The null hypothesis is that there is no relationship between ginseng administration and cerebral ischemic events including ischemic stroke and transient ischemic attack. The number of participants who suffered ischemic stroke and the number of paticipants who suffered transient ischemic attack were analyzed together to test the null hypothesis in two by two table.||||0.462
71028466|NCT02796664|141564417|OTHER|Equality test||||||0.34|||||||Fisher Exact|||The null hypothesis is that there is no relationship between ginseng administration and modified Rankin Scale at follow-up.||||0.34
71028467|NCT02796664|141564418|OTHER|Equality test||||||0.13|||||||Fisher Exact|||The null hypothesis is that there is no relationship between ginseng administration and flow change in steno-occlusive lesion.||||0.13
71028468|NCT02796664|141564418|OTHER|Equality test||||||0.17|||||||Chi-squared|||The null hypothesis is that there is no relationship between ginseng administration and flow change in collateral vessel.||||0.17
71028469|NCT02796664|141564419|OTHER|Equality test||||||0.74|||||||Fisher Exact|||The null hypothesis is that there is no relationship between ginseng administration and periventricular white matter lesions at follow-up.||||0.74
71028470|NCT02796664|141564419|OTHER|Equality test||||||0.95|||||||Fisher Exact|||The null hypothesis is that there is no relationship between ginseng administration and deep white matter lesions at follow-up.||||0.95
71028471|NCT02796664|141564420|OTHER|Equality test||||||0.23|||||||Chi-squared|||The null hypothesis is that there is no relationship between ginseng administration and parenchymal ischemic lesions at follow-up.||||0.23
71028472|NCT02796664|141564421|OTHER|Equality test||||||0.79|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no relationship between ginseng administration and drug compliance at follow-up.||||0.79
71028473|NCT04128007|141564455|SUPERIORITY||Odds Ratio (OR)|14.65|||<|0.0001|TWO_SIDED|95.0|6.64|32.32|||Cochran-Mantel-Haenszel|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|S-IGA Success at Week 8 Odds Ratio||32.32|6.64|<0.0001
71028474|NCT04128007|141564456|SUPERIORITY||Odds Ratio (OR)|8.8|||<|0.0001|TWO_SIDED|95.0|3.65|21.18|||Cochran-Mantel-Haenszel|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|B-IGA Success at Week 8 Odds Ratio||21.18|3.65|<0.0001
71028475|NCT04128007|141564457|SUPERIORITY||Odds Ratio (OR)|4.06|||<|0.0001|TWO_SIDED|95.0|2.14|7.71|||Cochran-Mantel-Haenszel|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|SI-NRS Success at Week 2 Odds Ratio||7.71|2.14|<0.0001
71028476|NCT04128007|141564457|SUPERIORITY||Odds Ratio (OR)|5.36|||<|0.0001|TWO_SIDED|95.0|2.93|9.78||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Cochran-Mantel-Haenszel||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|SI-NRS Success at Week 4 Odds Ratio||9.78|2.93|<0.0001
71028477|NCT04128007|141564457|SUPERIORITY||Odds Ratio (OR)|9.74|||<|0.0001|TWO_SIDED|95.0|5.02|18.89||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Cochran-Mantel-Haenszel||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|SI-NRS Success at Week 8 Odds Ratio||18.89|5.02|<0.0001
71028478|NCT04128007|141564458|SUPERIORITY||Least Squares Mean Difference|-19.6|||<|0.0001|TWO_SIDED|95.0|-27.4|-11.8|||ANCOVA|ANCOVA with country; treatment; and baseline S-IGA, B-IGA, and PSD scores as independent variables with multiple imputation of missing data.|ANCOVA with country; treatment; and baseline S-IGA, B-IGA, and PSD scores as independent variables with multiple imputation of missing data.|Comparison of Week 4 Change from Baseline||-11.8|-27.4|<0.0001
71028479|NCT04128007|141564458|SUPERIORITY||Least Squares Mean Difference|-27.5|||<|0.0001|TWO_SIDED|95.0|-35.5|-19.5|||ANCOVA|ANCOVA with country; treatment; and baseline S-IGA, B-IGA, and PSD scores as independent variables with multiple imputation of missing data.|ANCOVA with country; treatment; and baseline S-IGA, B-IGA, and PSD scores as independent variables with multiple imputation of missing data.|Comparison of Week 8 Change from Baseline||-19.5|-35.5|<0.0001
71028480|NCT04128007|141564459|SUPERIORITY||Hazard Ratio (HR)|3.94|||<|0.0001|TWO_SIDED|95.0|2.764|5.616||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization.|Log Rank||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization.|Time to PSSI-50 Hazard Ratio||5.616|2.764|<0.0001
71068589|NCT00791661|141646031|SUPERIORITY_OR_OTHER||Diffrence in least squares mean|-36.3|||<|0.001|TWO_SIDED|90.0|-52.0|-20.5||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 60 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-20.5|-52.0|<.001
71068590|NCT00791661|141646031|SUPERIORITY_OR_OTHER||Difference in least squares mean|-19.7||||0.147|TWO_SIDED|90.0|-42.2|2.7|||Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 60 mg fed minus LS mean for placebo fed.|||2.7|-42.2|0.147
71068591|NCT00791661|141646031|SUPERIORITY_OR_OTHER||Difference in least squares mean|12.3||||0.114|TWO_SIDED|90.0|-0.5|25.2|||Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|Difference in least squares mean (LS mean) was calculated as LS mean for MK-1006 60 mg minus LS mean for MK-1006 60 mg fed.|||25.2|-0.5|0.114
71068592|NCT00791661|141646031|SUPERIORITY_OR_OTHER||Difference in least squares mean|-28.9||||0.026|TWO_SIDED|90.0|-49.9|-7.9|||Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for placebo fed minus LS mean for placebo.|||-7.9|-49.9|0.026
71068593|NCT00791661|141646031|SUPERIORITY_OR_OTHER||Difference in least squares mean|-57.6|||<|0.001|TWO_SIDED|90.0|-73.3|-41.9||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 80 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-41.9|-73.3|<.001
71068594|NCT00791661|141646031|SUPERIORITY_OR_OTHER||Difference in least squares mean|-15.3||||0.099|TWO_SIDED|90.0|-30.5|-0.1||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 100 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-0.1|-30.5|0.099
71068595|NCT00791661|141646031|SUPERIORITY_OR_OTHER||Difference in least squares mean|-43.9|||<|0.001|TWO_SIDED|90.0|-60.8|-27.0||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 140 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-27.0|-60.8|<.001
71112684|NCT00191945|141732569|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.56||||0.419||95.0|-2.26|5.39||P-value for Parent: Resilience difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||5.39|-2.26|0.419
71068596|NCT00791661|141646031|SUPERIORITY_OR_OTHER||Difference in least squares mean|-59.4|||<|0.001|TWO_SIDED|90.0|-75.1|-43.7||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 170 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-43.7|-75.1|<.001
71068597|NCT00305084|141646135|OTHER||MDT|1.6|||||TWO_SIDED|||||||||All data regarding safety were registered and analyzed by descriptive analyses. Summary table were generated to document the safety|at least 3 patients per cohort had to be enrolled with expansion to 6 in presence of Dose Limiting Toxicity(DLT) (stop escalation if 2 or more DLTs at the same dose level). With a projection to achieve the highest level of NGR-hTNF, without significative toxicity (1.6 μg/m2) a planned sample of 20-25 patients was expected. DLTs were defined as: any severe toxicity clearly related to the administration of NGR-hTNF. The patient was defined assessable, according to the standard analysis, if he/she received at least one infusion of the investigational product. Maximal Tollerated Dose (MTD) was defined as the dose which produces DLTs in 2 or more patients out of 6 and will be recommended for phase II trials.|||
71068598|NCT00926848|141646154|SUPERIORITY||Mean Difference (Final Values)|4.0|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
71068599|NCT00926848|141646155|SUPERIORITY||Mean Difference (Final Values)|6.6|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
71068600|NCT00926848|141646156|SUPERIORITY||Mean Difference (Final Values)|0.3|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
71068601|NCT00926848|141646157|SUPERIORITY||Mean Difference (Final Values)|0.6|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
71068602|NCT00926848|141646158|SUPERIORITY||Mean Difference (Final Values)|0.3|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
71068603|NCT00926848|141646159|SUPERIORITY||Mean Difference (Final Values)|0.8|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
71068604|NCT01167881|141646160|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.46|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|97.5|-4.87|-4.05||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline weight, baseline HbA1c as linear covariates.||"Testing Hierarchy for main analysis (104 weeks):~1. Non-inferiority in HbA1c change from baseline at 104 weeks,~2. Superiority in body weight change from baseline at 104 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~4. Superiority in HbA1c change from baseline at 104 weeks,~5. Superiority in systolic blood pressure change from baseline at 104 weeks,~6. Superiority in diastolic blood pressure change from baseline at 104 weeks."||-4.05|-4.87|<0.0001
71068605|NCT01167881|141646161|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested through a two-sided 97.5% confidence interval for the treatment effect of empagliflozin minus the effect of glimepiride in change from baseline in HbA1c. The null-hypothesis of material inferiority of empagliflozin was rejected if the confidence interval is entirely below the non-inferiority margin 0.3%.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|97.5|-0.2|-0.01|||ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline HbA1c as linear covariate.||"Testing Hierarchy for main analysis (104 weeks):~1. Non-inferiority in HbA1c change from baseline at 104 weeks,~2. Superiority in body weight change from baseline at 104 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~4. Superiority in HbA1c change from baseline at 104 weeks,~5. Superiority in systolic blood pressure change from baseline at 104 weeks,~6. Superiority in diastolic blood pressure change from baseline at 104 weeks."||-0.01|-0.20|<0.0001
71068606|NCT01167881|141646161|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.04||0.0153|TWO_SIDED|97.5|-0.2|-0.01||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline HbA1c as linear covariate.||"Testing Hierarchy for main analysis (104 weeks):~1. Non-inferiority in HbA1c change from baseline at 104 weeks,~2. Superiority in body weight change from baseline at 104 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~4. Superiority in HbA1c change from baseline at 104 weeks,~5. Superiority in systolic blood pressure change from baseline at 104 weeks,~6. Superiority in diastolic blood pressure change from baseline at 104 weeks."||-0.01|-0.20|0.0153
71068607|NCT01167881|141646162|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.102|||<|0.0001|TWO_SIDED|97.5|0.06|0.173||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for baseline HbA1c (\<8.5 / \>=8.5).||"Testing Hierarchy for main analysis (104 weeks):~1. Non-inferiority in HbA1c change from baseline at 104 weeks,~2. Superiority in body weight change from baseline at 104 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~4. Superiority in HbA1c change from baseline at 104 weeks,~5. Superiority in systolic blood pressure change from baseline at 104 weeks,~6. Superiority in diastolic blood pressure change from baseline at 104 weeks."||0.173|0.060|<0.0001
71068608|NCT01167881|141646163|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.6|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|97.5|-7.0|-4.2||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline SBP, baseline HbA1c as linear covariates.||"Testing Hierarchy for main analysis (104 weeks):~1. Non-inferiority in HbA1c change from baseline at 104 weeks,~2. Superiority in body weight change from baseline at 104 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~4. Superiority in HbA1c change from baseline at 104 weeks,~5. Superiority in systolic blood pressure change from baseline at 104 weeks,~6. Superiority in diastolic blood pressure change from baseline at 104 weeks."||-4.2|-7.0|<0.0001
70852774|NCT01578850|141194348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.19||||0.001|TWO_SIDED|95.0|-13.2|-3.18|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||General Health VAS: Week 44||-3.18|-13.20|0.001
71078628|NCT02756819|141665156|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Neither diabetes mellitus nor metabolic syndrome)|Wilcoxon test|||||||<0.001
71078629|NCT02756819|141665156|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Metabolic syndrome)|Wilcoxon test|||||||<0.001
71078630|NCT02756819|141665157|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Overweight)|Wilcoxon test|||||||<0.001
70941928|NCT03866434|141384007|EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%.|%ratio of Geometric LeastSquare(LS)means|82.203|||||TWO_SIDED|90.0|71.501|94.507|||ANOVA|A 2-factor analysis of variance (ANOVA) model with fixed factors for treatment and participant was fitted to the natural logtransformed PK parameters.|This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole \[Day 8\] versus anagrelide alone \[Day 1\]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the LS mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CI were calculated.||94.507|71.501|
71078631|NCT02756819|141665157|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class I)|Wilcoxon test|||||||<0.001
71078632|NCT02756819|141665157|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class II)|Wilcoxon test|||||||<0.001
71068609|NCT01167881|141646164|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|97.5|-3.5|-1.8||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline DBP, baseline HbA1c as linear covariates.||"Testing Hierarchy for main analysis (104 weeks):~1. Non-inferiority in HbA1c change from baseline at 104 weeks,~2. Superiority in body weight change from baseline at 104 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~4. Superiority in HbA1c change from baseline at 104 weeks,~5. Superiority in systolic blood pressure change from baseline at 104 weeks,~6. Superiority in diastolic blood pressure change from baseline at 104 weeks."||-1.8|-3.5|<0.0001
71068610|NCT01167881|141646165|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested through a two-sided 97.5% confidence interval for the treatment effect of empagliflozin minus the effect of glimepiride in change from baseline in HbA1c. The null-hypothesis of material inferiority of empagliflozin was rejected if the confidence interval is entirely below the non-inferiority margin 0.3%.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|97.5|-0.16|0.02|||ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline HbA1c as linear covariate.||"Testing Hierarchy for first interim analysis (52 weeks):~1. Non-inferiority in HbA1c change from baseline at 52 weeks,~2. Superiority in body weight change from baseline at 52 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 52 weeks,~4. Superiority in systolic blood pressure change from baseline at 52 weeks,~5. Superiority in diastolic blood pressure change from baseline at 52 weeks."||0.02|-0.16|<0.0001
71068611|NCT01167881|141646166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.81|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|97.5|-5.16|-4.46||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline weight, baseline HbA1c as linear covariates.||"Testing Hierarchy for first interim analysis (52 weeks):~1. Non-inferiority in HbA1c change from baseline at 52 weeks,~2. Superiority in body weight change from baseline at 52 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 52 weeks,~4. Superiority in systolic blood pressure change from baseline at 52 weeks,~5. Superiority in diastolic blood pressure change from baseline at 52 weeks."||-4.46|-5.16|<0.0001
71068612|NCT01167881|141646167|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.077|||<|0.0001|TWO_SIDED|97.5|0.04|0.148||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for baseline HbA1c (\<8.5 / \>=8.5).||"Testing Hierarchy for first interim analysis (52 weeks):~1. Non-inferiority in HbA1c change from baseline at 52 weeks,~2. Superiority in body weight change from baseline at 52 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 52 weeks,~4. Superiority in systolic blood pressure change from baseline at 52 weeks,~5. Superiority in diastolic blood pressure change from baseline at 52 weeks."||0.148|0.040|<0.0001
71068613|NCT01167881|141646168|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.8|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|97.5|-7.3|-4.4||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline SBP, baseline HbA1c as linear covariates.||"Testing Hierarchy for first interim analysis (52 weeks):~1. Non-inferiority in HbA1c change from baseline at 52 weeks,~2. Superiority in body weight change from baseline at 52 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 52 weeks,~4. Superiority in systolic blood pressure change from baseline at 52 weeks,~5. Superiority in diastolic blood pressure change from baseline at 52 weeks."||-4.4|-7.3|<0.0001
71068614|NCT01167881|141646169|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.8|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|97.5|-3.7|-2.0||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline DBP, baseline HbA1c as linear covariates.||"Testing Hierarchy for first interim analysis (52 weeks):~1. Non-inferiority in HbA1c change from baseline at 52 weeks,~2. Superiority in body weight change from baseline at 52 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 52 weeks,~4. Superiority in systolic blood pressure change from baseline at 52 weeks,~5. Superiority in diastolic blood pressure change from baseline at 52 weeks."||-2.0|-3.7|<0.0001
71068615|NCT02235077|141646213|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.5688|TWO_SIDED|95.0|-0.11|0.2|||Regression, Linear|||||0.20|-0.11|0.5688
71068616|NCT02235077|141646214|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.4155|TWO_SIDED|95.0|-0.35|0.86|||Regression, Linear|||||0.86|-0.35|0.4155
71068617|NCT02235077|141646215|SUPERIORITY||Odds Ratio (OR)|1.23||||0.3039|TWO_SIDED|95.0|0.83|1.81|||Chi-squared|||||1.81|0.83|0.3039
71112685|NCT00191945|141732569|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.41|||<|0.001||95.0|4.27|12.55||P-value for Parent:Risk Avoidance difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||12.55|4.27|<0.001
71112686|NCT00191945|141732569|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.39||||0.042||95.0|0.13|6.65||P-value for Parent:Achievement difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||6.65|0.13|0.042
71068618|NCT02235077|141646216|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.7673|TWO_SIDED|95.0|-0.09|0.07|||Regression, Linear|||||0.07|-0.09|0.7673
70852775|NCT01578850|141194348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6|||<|0.001|TWO_SIDED|95.0|-13.64|-3.55|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||General Health VAS: Week 52||-3.55|-13.64|<0.001
70852776|NCT01578850|141194348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.91||||0.017|TWO_SIDED|95.0|-10.75|-1.06|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Pain VAS: Week 28||-1.06|-10.75|0.017
71068619|NCT02235077|141646217|SUPERIORITY||Mean Difference (Final Values)|319.2||||0.5734|TWO_SIDED|95.0|-797.4|1435.8|||Regression, Linear|||||1435.8|-797.4|0.5734
71068620|NCT02235077|141646218|SUPERIORITY||Mean Difference (Final Values)|-1.02||||0.3528|TWO_SIDED|95.0|-3.05|1.01|||Regression, Linear|||||1.01|-3.05|0.3528
71068621|NCT02235077|141646219|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.0846|TWO_SIDED|95.0|-0.02|0.25|||Regression, Linear|||||0.25|-0.02|0.0846
71068622|NCT02235077|141646220|SUPERIORITY||Mean Difference (Final Values)|-12.17||||0.0842|TWO_SIDED|95.0|-25.98|1.65|||Regression, Linear|||||1.65|-25.98|0.0842
71068623|NCT02235077|141646221|SUPERIORITY||Odds Ratio (OR)|1.11||||0.7628|TWO_SIDED|95.0|0.56|2.23|||Regression, Logistic|||||2.23|0.56|0.7628
71068624|NCT02235077|141646222|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.6102|TWO_SIDED|95.0|-5.02|2.95|||Regression, Linear|||||2.95|-5.02|0.6102
71068625|NCT02235077|141646223|SUPERIORITY||Odds Ratio (OR)|0.76||||0.5818|TWO_SIDED|95.0|0.29|1.99|||Regression, Logistic|||||1.99|0.29|0.5818
71068626|NCT00586820|141646226|SUPERIORITY_OR_OTHER|||||||0.029|||||||t-test, 2 sided|||||||0.029
71068627|NCT00586820|141646227|SUPERIORITY_OR_OTHER|||||||0.019|||||||t-test, 2 sided|||Change between the groups from immediate pre-PCI and 8 hours post PCI.||||0.019
71068628|NCT00586820|141646227|SUPERIORITY_OR_OTHER|||||||0.007|||||||t-test, 2 sided|||Change between the groups from immediate pre-PCI and 16 hours post-PCI.||||0.007
71068629|NCT01217476|141646272|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.4039|TWO_SIDED|95.0|0.66|2.8|||Regression, Logistic|||||2.80|0.66|0.4039
71068630|NCT01217476|141646273|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.52|1.56|||Regression, Logistic|||||1.56|0.52|
71068631|NCT01672710|141646274|SUPERIORITY||Mean Difference (Net)|6.9|||<|0.05|TWO_SIDED|95.0|-0.3|14.2|||ANCOVA|||||14.2|-0.3|<0.05
71068632|NCT02122887|141646281|OTHER|χ² (1) =4.57, Cramer's V=.24|||||<|0.05|||||||Chi-squared|||we hypothesised that following intervention, those undergoing intervention will be more likely to see justice on both sides, compared to control group||||<0.05
71068633|NCT02122887|141646282|EQUIVALENCE|we compared participants levels of tension (in their interaction with an outgroup member in trail 2) in an interaction test between perspective-taking levels and group|Mean Difference (Final Values)|0.65|||>|0.05|TWO_SIDED|95.0|||||ANOVA|df=1||||||>0.05
71068634|NCT02122887|141646283|EQUIVALENCE|we compared participants levels of empathy (in their interaction with an outgroup member in trail 2) in an interaction test between perspective-taking levels and group|Mean Difference (Final Values)|0.04|||>|0.05|TWO_SIDED|95.0|||||ANOVA|||||||>0.05
70852777|NCT01578850|141194348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6||||0.001|TWO_SIDED|95.0|-13.85|-3.34|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Pain VAS: Week 36||-3.34|-13.85|0.001
71068635|NCT01767506|141646302|SUPERIORITY||Odds Ratio (OR)|2.6|||>|0.05|TWO_SIDED|95.0|0.56|11.9|||Regression, Logistic||||The null hypothesis was that we could further decrease infection to 1% or less in more of the communities in the surveillance intervention arm, compared to control communities.|11.9|0.56|>0.05
71068636|NCT01767506|141646303|SUPERIORITY||Mean Difference (Final Values)|3.9||||1|TWO_SIDED||||||Fisher Exact|||||||1
71068637|NCT03436693|141646341|OTHER|Point Estimate|Difference(Multiple imputation method)|11.3|||||TWO_SIDED|95.0|1.2|21.5||||||||21.5|1.2|
71068638|NCT03436693|141646342|OTHER|Point Estimate|Difference(Multiple imputation method)|3.8|||||TWO_SIDED|95.0|-4.1|11.7||||||||11.7|-4.1|
71068639|NCT03436693|141646343|SUPERIORITY||Difference of LSMean|1.09||||0.351|TWO_SIDED|95.0|-1.21|3.4|||Mixed Models Analysis|||||3.40|-1.21|0.351
71068640|NCT03436693|141646344|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.293|TWO_SIDED|95.0|0.23|1.55|||Regression, Cox|||||1.55|0.23|0.293
71068641|NCT03436693|141646345|SUPERIORITY||Ratio of Geometric LSMean|0.52|||<|0.001|TWO_SIDED|95.0|0.418|0.646|||Mixed Models Analysis|||||0.646|0.418|<0.001
71068642|NCT04967885|141646369|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
71068643|NCT01011465|141646371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4||||0.03||95.0|||||t-test, 2 sided|||The null hypothesis is that both groups will have similar rise in SBP in response to stress.||||0.03
71068644|NCT01011465|141646371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.89||95.0|||||t-test, 2 sided|||The null hypothesis is that both groups will have similar rise in SBP in response to stress.||||0.89
71068645|NCT01011465|141646371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.52||95.0|||||t-test, 2 sided|||The null hypothesis is that both groups will have similar rise in SBP in response to stress.||||0.52
71068646|NCT01011465|141646372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.43||95.0|||||t-test, 2 sided|||The null hypothesis states that both groups will have similar PANAS negative affect score change in response to stress.||||0.43
71068647|NCT01011465|141646372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96||||0.08||95.0|||||t-test, 2 sided|||The null hypothesis states that both groups will have similar PANAS negative affect score change in response to stress.||||0.08
71068648|NCT01011465|141646372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64||||0.25||95.0|||||ANOVA|||The null hypothesis states that both groups will have similar PANAS negative affect score change in response to stress.||||0.25
71068649|NCT01011465|141646373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.83||95.0|||||t-test, 2 sided|||The null hypothesis states that both groups had similar threat/challenge scores during the speech task.||||0.83
71068650|NCT01011465|141646373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.56||95.0|||||t-test, 2 sided|||The null hypothesis states that both groups had similar threat/challenge scores during the speech task.||||0.56
71068651|NCT01011465|141646373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.95||95.0|||||t-test, 2 sided|||The null hypothesis states that both groups had similar threat/challenge scores during the speech task.||||0.95
71068652|NCT01683266|141646469|NON_INFERIORITY_OR_EQUIVALENCE|"Stepwise closed testing approach was used to assess non-inferiority and superiority sequentially:~1. Non-inferiority of HOE901-U300 vs Lantus: Upper bound of two-sided 95% confidence interval (CI) of difference between HOE901-U300 and Lantus on mITT population is \<0.4%.~2. Superiority (only if non-inferiority has been demonstrated): Upper bound of two-sided 95% CI for difference in mean change in HbA1c from baseline to endpoint between HOE901-U300 and Lantus on mITT population is \<0."|Least Squares (LS) Mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.072|||TWO_SIDED|95.0|-0.098|0.185||||||Analysis was performed using mixed model for repeated measurements (MMRM) with treatment groups, strata of screening HbA1c (\<8.0, \>=8.0%), geographical region (Non-Japan; Japan), visit and visit-by-treatment groups interaction as fixed categorical effects; baseline HbA1c and baseline HbA1c-by-visit interaction as continuous fixed covariates.||0.185|-0.098|
71068653|NCT01683266|141646472|SUPERIORITY_OR_OTHER||LS Mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.322|||TWO_SIDED|95.0|-0.982|0.287||||||Change in pre-injection SMPG was analyzed using MMRM model with treatment groups, strata of screening HbA1c (\<8.0, \>=8.0%), geographical region (Non-Japan; Japan), visit and visit-by-treatment groups interaction as fixed categorical effects; pre-injection SMPG value and pre-injection SMPG value-by-visit interaction as continuous fixed covariates.||0.287|-0.982|
71068654|NCT00626821|141646560|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.813|STANDARD_ERROR_OF_MEAN|0.133|<|0.0001|TWO_SIDED|95.0|1.553|2.073|||Mixed Models Analysis|||||2.073|1.553|<0.0001
71068655|NCT02632409|141646561|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0008|TWO_SIDED|98.22|0.55|0.9|||Stratified Cox Proportional hazard model|||||0.90|0.55|0.0008
71068656|NCT02632409|141646562|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.0005|TWO_SIDED|98.72|0.35|0.84|||Stratified Cox Proportional hazard model|||||0.84|0.35|0.0005
71068657|NCT00537316|141646569|SUPERIORITY_OR_OTHER|||||||0.032||95.0|||||Chi-squared|||||||0.032
71068658|NCT01062113|141646590|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|38.2|STANDARD_ERROR_OF_MEAN|9.1|<|0.0001|TWO_SIDED|95.0|20.3|56.1||The difference in the efficacy rates was tested using normal distribution at a significance level of 2-sided 5%. 2-sided 95% confidence interval (CI) for the difference in the efficacy rates was calculated using normal approximation.|asymptotic z-test|||||56.1|20.3|<0.0001
71068659|NCT01062113|141646592|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0|||||t-test, 2 sided|||||||0.0003
71068660|NCT01062113|141646593|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
71068661|NCT01082211|141646641|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|||||||Chi-squared|||Assuming a 3-year rate of 25% using a chi-squared test, a sample size of 55 patients will ensure at least 90% probability of detecting a reduction in the 3-year ipsilateral in-breast recurrence rate from 25% to 9%, with a significance level of 0.05 (1-sided). In-breast recurrence will be estimated using the cumulative incidence method.||||0.0002
71068662|NCT01082211|141646649|OTHER||Effect size|0.1|||||TWO_SIDED||||||||Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7|Functional status||||
71068663|NCT01082211|141646649|OTHER||Effect size|0.14|||||TWO_SIDED||||||||Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7|Cosmetic||||
71068664|NCT01082211|141646649|OTHER||Effect size|0.34|||||TWO_SIDED||||||||Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7|Breast-specific pain||||
71068665|NCT01082211|141646650|OTHER||Effect size|0.04|||||TWO_SIDED||||||||Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7|Functional status||||
71068666|NCT01082211|141646650|OTHER||Effect size|0.32|||||TWO_SIDED||||||||Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7|Cosmetic||||
71068667|NCT01082211|141646650|OTHER||Effect size|0.28|||||TWO_SIDED||||||||Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7|Breast-specific pain||||
71068668|NCT01082211|141646652|OTHER|||||||0.054|||||||Spearman rank-order correlation test|||||||0.054
71068669|NCT01082211|141646652|OTHER|||||||0.044|||||||Spearman rank-order correlation test|||||||0.044
71068670|NCT01082211|141646652|OTHER|||||||0.087|||||||Spearman rank-order correlation test|||||||0.087
71068671|NCT03702010|141646658|SUPERIORITY|||||||0.112|||||||t-test, 2 sided|||Baseline VAS||||0.112
71068672|NCT03702010|141646658|SUPERIORITY|||||||0.323|||||||t-test, 2 sided|||After first stimulation VAS||||0.323
71068673|NCT03702010|141646658|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||After second stimulation||||0.760
71068674|NCT03702010|141646658|SUPERIORITY|||||||0.624|||||||t-test, 2 sided|||End of Follow-up||||0.624
71068675|NCT03702010|141646659|SUPERIORITY|||||||0.589|||||||t-test, 2 sided|||After first stimulation||||0.589
71068676|NCT03702010|141646659|SUPERIORITY|||||||0.704|||||||t-test, 2 sided|||After second stimulation||||0.704
71068677|NCT03702010|141646659|SUPERIORITY|||||||0.908|||||||t-test, 2 sided|||End of Follow-up||||0.908
70941975|NCT00088452|141384310|SUPERIORITY||Odds Ratio (OR)|3.34|||<|0.001|TWO_SIDED|95.0|2.06|5.42|||Chi-squared||odds ratio with valproic acid vs. lamotrigine|Calculations of sample size were based on the ability to detect a 20% difference in freedom-from failure rates (three pairwise comparisons) at 16 weeks with 80% power at a two-sided P value of 0.017 and one interim analysis. Sample size of 398 was increased to 446 subjects to account for two stratification factors and a 5% dropout rate; this sample size allowed the detection of a difference of 0.5 SD in the Confidence Index on the Conners' Continuous Performance Test with a power exceeding 80%.||5.42|2.06|<0.001
71068678|NCT03702010|141646660|SUPERIORITY|||||||0.231|||||||t-test, 2 sided|||Baseline||||0.231
71068679|NCT03702010|141646660|SUPERIORITY|||||||0.663|||||||t-test, 2 sided|||After first stimulation||||0.663
71068680|NCT03702010|141646660|SUPERIORITY|||||||0.998|||||||t-test, 2 sided|||After second stimulation||||0.998
71068681|NCT03702010|141646660|SUPERIORITY|||||||0.713|||||||t-test, 2 sided|||End of Follow-up||||0.713
71068682|NCT01080118|141646662|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.05||||0.001|TWO_SIDED|99.0|0.05|0.05|||t-test, 2 sided|||||.05|.05|.001
71068683|NCT01080118|141646662|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence||||||0.001||95.0|||||t-test, 2 sided|||||||.001
71068684|NCT01146379|141646675|SUPERIORITY_OR_OTHER|||||||0.01||||||a prior threshold for statistical significance = 0.05. P value was not corrected for multiple comparisons|Mixed Models Analysis|||The primary analysis used hierarchical linear modeling to examine the rate of change in ARAT over time. The null hypothesis was that all groups would change at a similar rate.||||.01
71068685|NCT01146379|141646675|SUPERIORITY_OR_OTHER|||||||0.036|||||||t-test, 2 sided|||This analysis then asked which groups were different from the Low Movement Dose group||||.036
71068686|NCT01146379|141646675|SUPERIORITY_OR_OTHER|||||||0.679|||||||t-test, 2 sided|||This analysis asked if the Low Movement Dose group was different from the High Movement Dose group||||0.679
71068687|NCT01146379|141646675|SUPERIORITY_OR_OTHER|||||||0.209|||||||t-test, 2 sided|||This analysis tested if the Low Movement Dose group was different from the Individual Maximum High Movement Dose group||||0.209
71068688|NCT02004886|141646687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.9|||<|0.001|TWO_SIDED|95.0|-38.4|-13.3|||ANCOVA|Terms for treatment, prior AHA therapy status, and baseline 24-hour WMG value as a covariate.||||-13.3|-38.4|<0.001
71068689|NCT02004886|141646687|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-53.6|||<|0.001|TWO_SIDED|95.0|-66.1|-41.1|||ANCOVA|Terms for treatment, prior AHA therapy status, and baseline 24-hour WMG value as a covariate.||||-41.1|-66.1|<0.001
71068690|NCT02004886|141646687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.0|||<|0.001|TWO_SIDED|95.0|-38.4|-13.6|||ANCOVA|Terms for treatment, prior AHA therapy status, and baseline 24-hour WMG value as a covariate.||||-13.6|-38.4|<0.001
70941976|NCT00088452|141384311|SUPERIORITY||Odds Ratio (OR)|1.95||||0.03|TWO_SIDED|95.0|1.12|3.41|||Chi-squared||Percentage of subjects with a Confidence Index score of 0.60 or higher in the valproic acid group than in the ethosuximide group|||3.41|1.12|0.03
71078633|NCT02756819|141665157|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class III)|Wilcoxon test|||||||<0.001
71078634|NCT02756819|141665157|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Normal glucose metabolism)|Wilcoxon test|||||||<0.001
71078635|NCT02756819|141665157|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Impaired glucose tolerance)|Wilcoxon test|||||||<0.001
71078636|NCT02756819|141665157|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Diabetes Mellitus - No)|Wilcoxon test|||||||<0.001
71078637|NCT02756819|141665157|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Diabetes Mellitus - Yes)|Wilcoxon test|||||||<0.001
71078638|NCT02756819|141665157|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Neither diabetes mellitus nor metabolic syndrome)|Wilcoxon test|||||||<0.001
71078639|NCT02756819|141665157|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Metabolic syndrome)|Wilcoxon test|||||||<0.001
71078640|NCT03539484|141665167|OTHER|A Bayesian approach is used to estimate the maximum tolerated dose (MTD).|Posterior probability at dose 1.8 mg|10.6|||||TWO_SIDED|95.0|2.1|26.5||There is no p-value derived; logistic regression is used to estimate the probability of DLT.|Regression, Logistic|||||26.5|2.10|
71078641|NCT00560703|141665199|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power calculation for this endpoint was driven by the assumptions made for the OSDI analysis||||||0.578||95.0|||||ANCOVA|||||||0.578
71078642|NCT00560703|141665200|SUPERIORITY_OR_OTHER_LEGACY|||||||0.293||95.0|||||ANCOVA|||It was anticipated that the difference between the treatment groups in mean reduction from baseline in OSDI scores will be approximately 7 points. A pooled standard deviation of 9.0 for the mean change from baseline OSDI score is expected. Under those assumptions a total of approximately 63 evaluable patients (42 COL-101 patients and 21 placebo patients) is sufficient to provide 80% power. The planned enrolment should provide enough evaluable patients to meet these assumptions.||||0.293
71078643|NCT03077607|141665213|EQUIVALENCE|Sample size of 15 participants was selected based on the estimated within participant % coefficient of variation (CV) of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|139.92|||||TWO_SIDED|90.0|113.26|172.87||||||Confidence interval (CI): 90 percent (%) CI on geometric least squares (LS) mean ratio (Test/Reference), test is talazoparib in combination with itraconazole and reference is talazoparib alone. Statistical data was calculated by using analysis of variance (ANOVA)||172.87|113.26|
71078644|NCT03077607|141665214|EQUIVALENCE|Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|150.71|||||TWO_SIDED|90.0|136.47|166.43||||||CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in combination with itraconazole and reference is talazoparib alone. Statistical data was calculated by using ANOVA.||166.43|136.47|
71078645|NCT03077607|141665215|EQUIVALENCE|Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|156.24|||||TWO_SIDED|90.0|137.58|177.42||||||CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in combination with itraconazole and reference is talazoparib alone. Statistical data was calculated by using ANOVA.||177.42|137.58|
71078646|NCT03077607|141665216|EQUIVALENCE|Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|136.62|||||TWO_SIDED|90.0|103.2|180.87||||||CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in combination with rifampin and reference is talazoparib alone. Statistical data was calculated by using ANOVA.||180.87|103.20|
71078647|NCT03077607|141665217|EQUIVALENCE|Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|105.37|||||TWO_SIDED|90.0|98.04|113.24||||||CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in Combination with rifampin and reference is talazoparib alone. Statistical data was calculated by using ANOVA.||113.24|98.04|
71078648|NCT03077607|141665218|EQUIVALENCE|Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|102.04|||||TWO_SIDED|90.0|94.02|110.74||||||CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in Combination with rifampin and reference is talazoparib alone. Statistical data was calculated by using ANOVA.||110.74|94.02|
71078649|NCT06010732|141665264|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.986|TWO_SIDED|95.0|-5.5|5.4||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Test-Positive Control|Based on previous studies we estimate the standard deviation of the differences between treatments in the crossover model to be 20 for % SMH recovery. With a sample size of 58 subjects completing the study, the study had 80% power to detect a difference between any two treatments of 7.5 for % SMH recovery, assuming two-sided tests each conducted at a 5% significance level.||5.4|-5.5|0.986
71078650|NCT06010732|141665264|SUPERIORITY||Mean Difference (Final Values)|27.2|||<|0.001|TWO_SIDED|95.0|21.7|32.6||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Test-Placebo|Based on previous studies we estimate the standard deviation of the differences between treatments in the crossover model to be 20 for % SMH recovery. With a sample size of 58 subjects completing the study, the study had 80% power to detect a difference between any two treatments of 7.5 for % SMH recovery, assuming two-sided tests each conducted at a 5% significance level.||32.6|21.7|<0.001
71079095|NCT03035916|141666056|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."||||0.001
71112687|NCT00191945|141732569|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.36||||0.323||95.0|-4.06|1.35||P-value for Child/Adolescent:Satisfaction difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||1.35|-4.06|0.323
71112688|NCT00191945|141732569|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.92||||0.452||95.0|-1.49|3.34||P-value for Child/Adolescent:Comfort difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||3.34|-1.49|0.452
71112689|NCT00191945|141732569|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.91||95.0|-2.59|2.9||P-value for Child/Adolescent:Resilience difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||2.90|-2.59|0.910
71112690|NCT00191945|141732569|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.56||||0.006||95.0|1.04|6.08||P-value for Child/Adolescent:Risk Avoidance difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||6.08|1.04|0.006
71112691|NCT00191945|141732569|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.99||||0.541||95.0|-2.21|4.19||P-value for Child/Adolescent:Achievement difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||4.19|-2.21|0.541
71112692|NCT01576939|141732633|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.0||||0.9906|TWO_SIDED|95.0|0.979|1.022|||Regression, Cox|This was a Cox proportional hazards model with dose as the single predictor.||||1.022|0.979|0.9906
71112693|NCT01576939|141732634|SUPERIORITY_OR_OTHER||Slope|0.2795||||0.1209|TWO_SIDED|95.0|-0.077|0.634|||Regression, Linear|Linear regression model with dose as the single predictor in the model.||||0.634|-0.077|0.1209
71112694|NCT01576939|141732635|SUPERIORITY_OR_OTHER||Slope|-0.285||||0.9832|TWO_SIDED|95.0|-27.28|26.71|||Regression, Linear|Linear regression model with dose as the single predictor in the model.||||26.71|-27.28|0.9832
71112695|NCT01576939|141732636|SUPERIORITY_OR_OTHER||Slope|0.03795||||0.0263|TWO_SIDED|95.0|0.00483|0.071|||Mixed Models Analysis|A repeated measures model with dose as the single predictor. QoL values were measured for each patient every week.||||0.071|0.00483|0.0263
71112696|NCT01576939|141732637|SUPERIORITY_OR_OTHER||Slope|0.0567||||0.0039|TWO_SIDED|95.0|0.0199|0.0935|||Mixed Models Analysis|A repeated measures model with dose as the single predictor and QoL values measured each week for each patient.||||0.0935|0.0199|0.0039
71112697|NCT02470585|141732660|SUPERIORITY|Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints.|Hazard Ratio (HR)|0.435|||<|0.001|TWO_SIDED|95.0|0.277|0.683||A 2-sided p-value of ≤ 0.05 was considered statistically significant in the following hierarchical testing sequence: PFS was to be compared first in the BRCA-mutation cohort, then in the HRD cohort, and then in the ITT population.|Log Rank|Stratified according to residual disease status and disease stage.|Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|The primary efficacy analyses compared investigator-assessed PFS in the Veliparib + Carboplatin + Paclitaxel -\> Veliparib group (Arm 3) vs. the Placebo + Carboplatin + Paclitaxel -\> Placebo group (Arm 1).||0.683|0.277|<0.001
71112698|NCT02470585|141732661|SUPERIORITY|Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints.|Hazard Ratio (HR)|0.572|||<|0.001|TWO_SIDED|95.0|0.433|0.756||A 2-sided p-value of ≤ 0.05 was considered statistically significant in the following hierarchical testing sequence: PFS was to be compared first in the BRCA-mutation cohort, then in the HRD cohort, and then in the ITT population.|Log Rank|Stratified according to residual disease status and disease stage.|Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|The primary efficacy analyses compared investigator-assessed PFS in the Veliparib + Carboplatin + Paclitaxel -\> Veliparib group (Arm 3) vs. the Placebo + Carboplatin + Paclitaxel -\> Placebo group (Arm 1).||0.756|0.433|<0.001
71117673|NCT01559259|141740589|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.24|||<|0.001|TWO_SIDED|95.0|0.15|0.39||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||0.39|0.15|<0.001
71112699|NCT02470585|141732662|SUPERIORITY|Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints.|Hazard Ratio (HR)|0.683|||<|0.001|TWO_SIDED|95.0|0.562|0.831||A 2-sided p-value of ≤ 0.05 was considered statistically significant in the following hierarchical testing sequence: PFS was to be compared first in the BRCA-mutation cohort, then in the HRD cohort, and then in the ITT population.|Log Rank|Stratified according to residual disease status and disease stage, choice of the paclitaxel regimen, and BRCA-mutation status|Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|The primary efficacy analyses compared investigator-assessed PFS in the Veliparib + Carboplatin + Paclitaxel -\> Veliparib group (Arm 3) vs. the Placebo + Carboplatin + Paclitaxel -\> Placebo group (Arm 1).||0.831|0.562|<0.001
71112700|NCT02470585|141732663|SUPERIORITY|Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints.|Hazard Ratio (HR)|1.215||||0.335|TWO_SIDED|95.0|0.821|1.799|||Log Rank|Stratified according to residual disease status and disease stage.|Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|The secondary efficacy analyses compared investigator-assessed PFS in the Veliparib + Carboplatin + Paclitaxel -\> Placebo group (Arm 2) vs. the Placebo + Carboplatin + Paclitaxel -\> Placebo group (Arm 1).||1.799|0.821|0.335
71112701|NCT02470585|141732664|SUPERIORITY|Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints.|Hazard Ratio (HR)|1.1||||0.462|TWO_SIDED|95.0|0.855|1.414|||Log Rank|Stratified according to residual disease status and disease stage.|Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|The secondary efficacy analyses compared investigator-assessed PFS in the Veliparib + Carboplatin + Paclitaxel -\> Placebo group (Arm 2) vs. the Placebo + Carboplatin + Paclitaxel -\> Placebo group (Arm 1).||1.414|0.855|0.462
71112702|NCT02470585|141732665|SUPERIORITY|Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints.|Hazard Ratio (HR)|1.073||||0.45|TWO_SIDED|95.0|0.895|1.287|||Log Rank|Stratified according to residual disease status and disease stage, choice of the paclitaxel regimen, and BRCA-mutation status|Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|The secondary efficacy analyses compared investigator-assessed PFS in the Veliparib + Carboplatin + Paclitaxel -\> Placebo group (Arm 2) vs. the Placebo + Carboplatin + Paclitaxel -\> Placebo group (Arm 1).||1.287|0.895|0.450
71112703|NCT02470585|141732666|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.328|TWO_SIDED|95.0|0.567|1.429||Stratified by residual disease (no residual disease after primary surgery versus any residual disease after primary surgery or interval surgery) and stage of disease (stage III versus stage IV)|Log Rank||Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above|Veliparib + Carboplatin + Paclitaxel -\> Veliparib (Arm 3) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)||1.429|0.567|0.328
71112704|NCT02470585|141732666|SUPERIORITY||Hazard Ratio (HR)|1.218||||0.808|TWO_SIDED|95.0|0.78|1.903||Stratified by residual disease (no residual disease after primary surgery versus any residual disease after primary surgery or interval surgery) and stage of disease (stage III versus stage IV)|Log Rank||Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|Veliparib + Carboplatin + Paclitaxel -\> Placebo (Arm 2) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)||1.903|0.780|0.808
71112705|NCT02470585|141732667|SUPERIORITY||Hazard Ratio (HR)|0.844||||0.116|TWO_SIDED|95.0|0.64|1.114||Stratified by residual disease (no residual disease after primary surgery versus any residual disease after primary surgery or interval surgery) and stage of disease (stage III versus stage IV)|Log Rank||Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|Veliparib + Carboplatin + Paclitaxel -\> Veliparib (Arm 3) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)||1.114|0.640|0.116
71112706|NCT02470585|141732667|SUPERIORITY||Hazard Ratio (HR)|0.949||||0.352|TWO_SIDED|95.0|0.726|1.242||Stratified by residual disease (no residual disease after primary surgery versus any residual disease after primary surgery or interval surgery) and stage of disease (stage III versus stage IV)|Log Rank||Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|Veliparib + Carboplatin + Paclitaxel -\> Placebo (Arm 2) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)||1.242|0.726|0.352
71112707|NCT02470585|141732668|SUPERIORITY||Hazard Ratio (HR)|0.946||||0.283|TWO_SIDED|95.0|0.782|1.144||Stratified by residual disease (none after primary surgery vs any residual disease after primary/interval surgery); disease stage (III vs IV); paclitaxel dosing (Q-weekly vs Q3-weekly); BRCA-Deficient status (Deficient vs wildtype or unknown/missing)|Log Rank|||Veliparib + Carboplatin + Paclitaxel -\> Veliparib (Arm 3) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)||1.144|0.782|0.283
71112708|NCT02470585|141732668|SUPERIORITY||Hazard Ratio (HR)|1.034||||0.638|TWO_SIDED|95.0|0.859|1.244||Stratified by residual disease (none after primary surgery vs any residual disease after primary/interval surgery); disease stage (III vs IV); paclitaxel dosing (Q-weekly vs Q3-weekly); BRCA-Deficient status (Deficient vs wildtype or unknown/missing)|Log Rank||Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above|Veliparib + Carboplatin + Paclitaxel -\> Placebo (Arm 2) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)||1.244|0.859|0.638
71112709|NCT00434993|141732676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|1.3||0.087|TWO_SIDED|95.0|-4.7|0.3||The p-value was not adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline shock.||The trial had a statistical power of 90.7% to detect a 2.25-day increase in VFDs,assuming a SD of 10.5 days. A group sequential design was used.||0.3|-4.7|0.087
71068691|NCT02004886|141646690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.3||||0.04|TWO_SIDED|95.0|-35.7|-0.9|||ANCOVA|Relevant baseline efficacy measurements were the covariates.||||-0.9|-35.7|0.04
71068692|NCT02004886|141646690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.6|||<|0.001|TWO_SIDED|95.0|-60.9|-26.3|||ANCOVA|Relevant baseline efficacy measurements were the covariates.||||-26.3|-60.9|<0.001
71068693|NCT02004886|141646690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6||||0.32|TWO_SIDED|95.0|-25.7|8.5|||ANCOVA|Relevant baseline efficacy measurements were the covariates.||||8.5|-25.7|0.320
71068694|NCT02004886|141646692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.751|TWO_SIDED|95.0|-0.7|0.9|||ANCOVA|||||0.9|-0.7|0.751
71068695|NCT02004886|141646692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.581|TWO_SIDED|95.0|-1.0|0.6|||ANCOVA|||||0.6|-1.0|0.581
71068696|NCT02004886|141646692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.918|TWO_SIDED|95.0|-0.8|0.8|||ANCOVA|||||0.8|-0.8|0.918
71068697|NCT02004886|141646694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.7||||0.253|TWO_SIDED|95.0|-21.1|5.6|||ANCOVA|||||5.6|-21.1|0.253
71068698|NCT02004886|141646694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.5||||0.07|TWO_SIDED|95.0|-26.0|1.0|||ANCOVA|||||1.0|-26.0|0.070
71068699|NCT02004886|141646694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.1|||<|0.001|TWO_SIDED|95.0|-39.5|-12.8|||ANCOVA|||||-12.8|-39.5|<0.001
71112710|NCT00434993|141732677|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.3||||0.302|TWO_SIDED|95.0|-4.0|14.7||The p-value was not adjusted for multiple comparisons.|Regression, Logistic|Adjusted for baseline shock.||||14.7|-4.0|0.302
71112711|NCT00434993|141732678|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.9||||0.261|TWO_SIDED|95.0|-3.7|15.4||The p-value was not adjusted for multiple comparisons.|Regression, Logistic|Adjusted for baseline shock.||||15.4|-3.7|0.261
71112712|NCT00434993|141732679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.023|TWO_SIDED|95.0|-4.9|-0.4||The p-value was not adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline shock.||||-0.4|-4.9|0.023
71112713|NCT00434993|141732680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.226|TWO_SIDED|95.0|-4.3|0.9||The p-value was not adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline shock.||||0.9|-4.3|0.226
71112714|NCT00434993|141732681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.13|TWO_SIDED|95.0|-5.3|0.6|||ANCOVA|Adjusted for baseline shock.||||0.6|-5.3|0.130
71112715|NCT00434993|141732682|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.2||||0.176|TWO_SIDED|95.0|-3.1|19.6|||Regression, Logistic|Adjusted for baseline shock.||||19.6|-3.1|0.176
71112716|NCT00434993|141732683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9||||0.048|TWO_SIDED|95.0|-7.8|0.0|||ANCOVA|||||-0.0|-7.8|0.048
71112717|NCT00434993|141732684|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.5||||0.265|TWO_SIDED|95.0|-6.9|25.9|||Regression, Logistic|||||25.9|-6.9|0.265
71112718|NCT02218697|141732691|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Control Group / Co-Ad Group) does not exceed 2.0.|Adjusted GMT ratio|1.13|||||TWO_SIDED|95.0|0.88|1.46|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for H1N1 strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate.||1.46|0.88|
71112719|NCT02218697|141732691|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Control Group / Co-Ad Group) does not exceed 2.0.|Adjusted GMT ratio|0.97|||||TWO_SIDED|95.0|0.78|1.21|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for H3N2 strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate.||1.21|0.78|
71112720|NCT02218697|141732691|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Control Group / Co-Ad Group) does not exceed 2.0.|Adjusted GMT ratio|1.17|||||TWO_SIDED|95.0|0.98|1.4|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for Victoria strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate.||1.40|0.98|
71068700|NCT02004886|141646695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-89.9||||0.002|TWO_SIDED|95.0|-145.6|-34.0|||ANCOVA|Relevant baseline efficacy measurements were the covariates.||||-34.0|-145.6|0.002
71068701|NCT02004886|141646695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-191.1|||<|0.001|TWO_SIDED|95.0|-246.4|-135.9|||ANCOVA|Relevant baseline efficacy measurements were the covariates.||||-135.9|-246.4|<0.001
71068702|NCT02004886|141646695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-97.7||||0.001|TWO_SIDED|95.0|-152.4|-42.9|||ANCOVA|Relevant baseline efficacy measurements were the covariates.||||-42.9|-152.4|0.001
71068703|NCT02004886|141646696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.408|TWO_SIDED|95.0|-1.5|3.7|||ANCOVA|||||3.7|-1.5|0.408
71068704|NCT02004886|141646696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.741|TWO_SIDED|95.0|-3.1|2.2|||ANCOVA|||||2.2|-3.1|0.741
71068705|NCT02004886|141646696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.906|TWO_SIDED|95.0|-2.8|2.5|||ANCOVA|||||2.5|-2.8|0.906
71068706|NCT02004886|141646697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.857|TWO_SIDED|95.0|-30.4|25.3|||ANCOVA|||||25.3|-30.4|0.857
71112721|NCT02218697|141732691|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Control Group / Co-Ad Group) does not exceed 2.0.|Adjusted GMT ratio|0.99|||||TWO_SIDED|95.0|0.84|1.16|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for Yamagata strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate.||1.16|0.84|
71112722|NCT02218697|141732692|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.14|||||TWO_SIDED|95.0|0.86|1.5|||ANCOVA||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 01 serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.||1.50|0.86|
71112723|NCT02218697|141732692|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.18|||||TWO_SIDED|95.0|0.96|1.45|||ANCOVA||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 03 serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.||1.45|0.96|
71112724|NCT02218697|141732692|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.26|||||TWO_SIDED|95.0|0.98|1.62|||ANCOVA||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 04 serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.||1.62|0.98|
71112725|NCT02218697|141732692|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.24|||||TWO_SIDED|95.0|0.95|1.63|||ANCOVA||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 7F serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.||1.63|0.95|
71112726|NCT02218697|141732692|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.2|||||TWO_SIDED|95.0|0.91|1.57|||ANCOVA||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 14 serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.||1.57|0.91|
70852778|NCT01578850|141194348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.49|||<|0.001|TWO_SIDED|95.0|-14.72|-4.26|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Pain VAS: Week 44||-4.26|-14.72|<0.001
71112727|NCT02218697|141732692|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.34|||||TWO_SIDED|95.0|1.05|1.7|||ANCOVA||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 19A serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.||1.70|1.05|
71112728|NCT03306433|141732710|EQUIVALENCE|The null hypothesis is that there are no significant paired differences between the groups. The power calculation is based on the observed variation and number of participants|Paired difference t-test|-12.139|STANDARD_DEVIATION|7.101||0.0003|TWO_SIDED|||||Paired difference p value comparing UDMA-K18 vs Adhesive Control|Paired difference test, 2 sided||There are 12 participants (pairs) for this comparison|Paired difference test within each participant.||||0.0003
71112729|NCT03306433|141732710|EQUIVALENCE|Null hypothesis was that there were no differences between the groups|Paired difference t-test|-7.412|STANDARD_DEVIATION|6.049||0.0063|TWO_SIDED|||||Paired differrnce between UDMA-K18 and UDMA control|Paired difference test, 2 sided||There are 9 participant pairs for this comparison|Paired comparison||||0.0063
71112730|NCT03306433|141732711|EQUIVALENCE|The Null hypothesis was that there would be no differences between the groups|Chi Square on WSL Index frequency|15.77||||0.0033|TWO_SIDED||||||Chi-squared|||WSL Index is non-parametric||||0.0033
70852779|NCT01578850|141194348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.29|||<|0.001|TWO_SIDED|95.0|-14.6|-3.99|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Pain VAS: Week 52||-3.99|-14.60|<0.001
71112731|NCT03306433|141732711|EQUIVALENCE|The null hypothesis was that there would not be any differences between the groups|Chi Square on WSL Index frequency|6.8321||||0.145|TWO_SIDED||||||Chi-squared|||||||0.1450
71068707|NCT02004886|141646697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.906|TWO_SIDED|95.0|-30.3|26.9|||ANCOVA|||||26.9|-30.3|0.906
71068708|NCT02004886|141646697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6||||0.63|TWO_SIDED|95.0|-34.0|20.8|||ANCOVA|||||20.8|-34.0|0.630
71068709|NCT01876784|141646701|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.08|TWO_SIDED|95.0|0.55|1.03||Threshold for significance at 0.05 level.|Log Rank||Vandetanib 300 mg vs Placebo|A multiple testing procedure (MTP) with an alpha-exhaustive recycling strategy was employed to provide adequate control of type I error.||1.03|0.55|0.080
71068710|NCT03605862|141646708|SUPERIORITY|||||||0.4009|||||||Gehan-Wilcoxon|Analysis was stratified by time from onset of symptoms, pre-enrollment symptom relief medication use, and presence of underlying lung conditions||||||0.4009
71068711|NCT03605862|141646709|SUPERIORITY|||||||0.1923|||||||Gehan-Wilcoxon|Analysis was stratified by time from onset of symptoms, pre-enrollment symptom relief medication use, and presence of underlying lung conditions||||||0.1923
71068712|NCT03605862|141646710|SUPERIORITY|||||||0.2057|||||||Fisher Exact|||||||0.2057
71068713|NCT03605862|141646711|SUPERIORITY|||||||0.0712|||||||Gehan-Wilcoxon|Analysis stratified by time from symptom onset at Baseline, pre-enrollment symptom relief medication use, and presence of underlying lung condition||||||0.0712
71068714|NCT03605862|141646712|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison for study day 2||||1.0000
71068715|NCT03605862|141646712|SUPERIORITY|||||||0.9142|||||||Fisher Exact|||Comparison for study day 3||||0.9142
71068716|NCT03605862|141646712|SUPERIORITY|||||||0.0132|||||||Fisher Exact|||Comparison for study day 7||||0.0132
71068717|NCT03605862|141646713|SUPERIORITY|||||||0.1239|||||||t-test, 2 sided|||Comparison for day 2||||0.1239
71068718|NCT03605862|141646713|SUPERIORITY|||||||0.1022|||||||t-test, 2 sided|||Comparison for day 3||||0.1022
71068719|NCT03605862|141646713|SUPERIORITY|||||||0.46213|||||||t-test, 2 sided|||Comparison for day 7||||0.46213
71068720|NCT03605862|141646716|SUPERIORITY|||||||0.014|||||||Gehan-Wilcoxon|Analysis stratified by time from symptom onset at first dose, pre-enrollment symptom relief medication use, and presence of underlying lung condition||||||0.0140
71068721|NCT03605862|141646717|SUPERIORITY|||||||0.0112|||||||Gehan-Wilcoxon|Analysis stratified by time from onset at first dose, pre-enrollment symptom relief medication use, and presence of underlying lung condition||||||0.0112
71068722|NCT03605862|141646718|SUPERIORITY||||||<|0.0001|||||||Gehan-Wilcoxon|Analysis stratified by time from onset at first dose, pre-enrollment symptom relief medication use, and presence of underlying lung condition||||||<0.0001
71068723|NCT05239494|141646723|SUPERIORITY||Median Difference (Final Values)|0.001|||<|0.001|TWO_SIDED||||||Shapiro-Wilks|||This study used a ±50 VAS scale, with values in the positive and negative range indicating that the contact lenses were comfortable or uncomfortable, respectively. A score of zero on this scale indicated neutral CL comfort.||||<0.001
71068724|NCT00937040|141646730|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline AISRS total score. Change from baseline to endpoint uses the latest non-missing score after baseline for each subject.|ANCOVA|P-value for Change from baseline at endpoint. Each outcome involved with gate-keeping will be numbered with a Gate-Keeper-Sequence-Number from 01-16.||Gate-Keeper-Sequence#01. The primary efficacy was tested at the 0.05 level of significance. To control the overall Type I error at 0.05, the secondary efficacy endpoints were tested in a fixed sequence if the preceding null hypothesis was rejected. No further hypotheses could be tested when the preceding null hypothesis was not rejected. All nominal p-values were presented even though the formal testing procedure stopped at the primary endpoint. No unqualified statements can be made.||||<0.001
71112732|NCT00294671|141732712|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in NIS+7 change from baseline to 2 years.||||<0.001
71112733|NCT00294671|141732712|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in NIS+7 change from baseline to 1years.||||0.02
71112734|NCT00294671|141732713|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in Kumamoto score change from baseline to 2 years.||||0.002
70852780|NCT01578850|141194350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.22||||0.014|TWO_SIDED|95.0|-9.39|-1.05|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CRP: Week 28||-1.05|-9.39|0.014
71068725|NCT00937040|141646731|SUPERIORITY_OR_OTHER|||||||0.206||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score. Endpoint for extended day sites is the 4 hour timepoint and for other sites is the last non-missing value after baseline.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#02.||||0.206
71068726|NCT00937040|141646732|SUPERIORITY_OR_OTHER|||||||0.348||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score. Endpoint for extended day sites is the 4 hour timepoint and for other sites is the last non-missing value after baseline.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#03.||||0.348
71068727|NCT00937040|141646733|SUPERIORITY_OR_OTHER|||||||0.324||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score. Endpoint for extended day sites is the 4 hour timepoint and for other sites is the last non-missing value after baseline.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#04.||||0.324
71068728|NCT00937040|141646734|SUPERIORITY_OR_OTHER|||||||0.631||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score. Endpoint for extended day sites is the 4 hour timepoint and for other sites is the last non-missing value after baseline.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#05.||||0.631
71068729|NCT00937040|141646735|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#06.||||<0.001
70852781|NCT01578850|141194350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.27||||0.011|TWO_SIDED|95.0|-11.09|-1.46|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CRP: Week 36||-1.46|-11.09|0.011
71068730|NCT00937040|141646736|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#07.||||<0.001
71068731|NCT00937040|141646737|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#08.||||0.008
71068732|NCT00937040|141646738|SUPERIORITY_OR_OTHER|||||||0.372||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#09.||||0.372
71068733|NCT00937040|141646739|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was determined by using the Cochran-Mantel-Haenszel (CMH) row mean scores controlling for center.|Cochran-Mantel-Haenszel|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#10.||||<0.001
71068734|NCT00937040|141646740|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value was determined using CMH general association controlling for pooled center.|Cochran-Mantel-Haenszel|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#11.||||0.008
71068735|NCT00937040|141646741|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#12.||||<0.001
71068736|NCT00937040|141646742|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#13.||||0.003
71068737|NCT00937040|141646743|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#14.||||0.016
71068738|NCT00937040|141646744|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#15.||||0.092
71068739|NCT00937040|141646745|SUPERIORITY_OR_OTHER|||||||0.284||95.0||||P-value was determined by using the Cochran-Mantel-Haenszel (CMH) row mean scores controlling for center. Missing/unknown responses are not included in the p-value.|Cochran-Mantel-Haenszel|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#16.||||0.284
71068740|NCT00937040|141646746|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|||P-value for Change from baseline at endpoint||||<0.001
71068741|NCT00937040|141646747|SUPERIORITY_OR_OTHER|||||||0.319||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|||P-value for Change from baseline at endpoint||||0.319
71068742|NCT00937040|141646748|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|||P-value for Change from baseline at endpoint||||0.007
71068743|NCT02120833|141646765|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
71068744|NCT02120833|141646765|SUPERIORITY_OR_OTHER|||||||0.436|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.4360
71068745|NCT02120833|141646765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.62||0.051|TWO_SIDED|95.0|-2.51|0.01||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.01|-2.51|0.0510
71068746|NCT02120833|141646766|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0004
71068747|NCT02120833|141646766|SUPERIORITY_OR_OTHER|||||||0.0213|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0213
71068748|NCT02120833|141646766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.22||0.7698|TWO_SIDED|95.0|-0.5|0.37|||ANCOVA|The significance threshold level was 0.05 (two-sided).||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.37|-0.50|0.7698
71068749|NCT02120833|141646767|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0003
71068750|NCT02120833|141646767|SUPERIORITY_OR_OTHER|||||||0.6063|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.6063
71068751|NCT02120833|141646767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.43||0.3686|TWO_SIDED|95.0|-1.27|0.48||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.48|-1.27|0.3686
71068752|NCT02120833|141646768|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
71068753|NCT02120833|141646768|SUPERIORITY_OR_OTHER|||||||0.6118|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.6118
71068754|NCT02120833|141646768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.56||0.1485|TWO_SIDED|95.0|-1.98|0.31||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.31|-1.98|0.1485
71068755|NCT02120833|141646769|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
71068756|NCT02120833|141646769|SUPERIORITY_OR_OTHER|||||||0.2447|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.2447
71068757|NCT02120833|141646769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|0.67||0.0216|TWO_SIDED|95.0|-2.95|-0.25||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.25|-2.95|0.0216
71068758|NCT02120833|141646770|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
71068759|NCT02120833|141646770|SUPERIORITY_OR_OTHER|||||||0.0476|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0476
71068760|NCT02120833|141646770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|0.78||0.2349|TWO_SIDED|95.0|-2.52|0.64||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.64|-2.52|0.2349
71068761|NCT02120833|141646771|SUPERIORITY_OR_OTHER|||||||0.7842|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.7842
71068762|NCT02120833|141646771|SUPERIORITY_OR_OTHER|||||||0.6083|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.6083
71068763|NCT02120833|141646771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.07||0.3599|TWO_SIDED|95.0|-0.08|0.22||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.22|-0.08|0.3599
71068764|NCT02120833|141646772|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0001
71068765|NCT02120833|141646772|SUPERIORITY_OR_OTHER|||||||0.0317|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0317
71068766|NCT02120833|141646772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.19||0.8037|TWO_SIDED|95.0|-0.42|0.33||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.33|-0.42|0.8037
71068767|NCT02120833|141646773|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
71068768|NCT02120833|141646773|SUPERIORITY_OR_OTHER|||||||0.0244|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0244
71068769|NCT02120833|141646773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.21||0.09|TWO_SIDED|95.0|-0.8|0.06||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.06|-0.80|0.0900
70852782|NCT01578850|141194350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.75|||<|0.001|TWO_SIDED|95.0|-12.06|-3.44|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CRP: Week 44||-3.44|-12.06|<0.001
70852783|NCT01578850|141194350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.16||||0.001|TWO_SIDED|95.0|-11.48|-2.85|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CRP: Week 52||-2.85|-11.48|0.001
71068770|NCT02120833|141646774|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
71068771|NCT02120833|141646774|SUPERIORITY_OR_OTHER|||||||0.0065|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0065
71068772|NCT02120833|141646774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.28||0.1561|TWO_SIDED|95.0|-0.97|0.16||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.16|-0.97|0.1561
71068773|NCT02120833|141646775|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
71068774|NCT02120833|141646775|SUPERIORITY_OR_OTHER|||||||0.0049|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0049
71079096|NCT03035916|141666056|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."||||0.001
71079097|NCT03035916|141666057|OTHER|||||||0.412|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."||||0.412
71079098|NCT03035916|141666057|OTHER|||||||0.592|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."||||0.592
71079099|NCT03035916|141666057|OTHER|||||||0.796|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."||||0.796
71079100|NCT03035916|141666057|OTHER|||||||0.576|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."||||0.576
71079101|NCT03035916|141666057|OTHER|||||||0.427|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."||||0.427
71079102|NCT03035916|141666057|OTHER|||||||0.201|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."||||0.201
71079103|NCT03035916|141666057|OTHER|||||||0.872|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."||||0.872
71079104|NCT03035916|141666057|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."||||0.001
71079105|NCT03035916|141666057|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."||||0.001
71079106|NCT03035916|141666057|OTHER|||||||0.165|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."||||0.165
71079107|NCT03035916|141666057|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."||||0.001
71079108|NCT03035916|141666057|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."||||0.001
71079109|NCT03035916|141666057|OTHER|||||||0.305|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."||||0.305
71079110|NCT03035916|141666057|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."||||0.001
71079111|NCT03035916|141666057|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."||||0.001
71079112|NCT03035916|141666058|OTHER|||||||0.673|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.673
71112735|NCT00294671|141732713|SUPERIORITY_OR_OTHER|||||||0.1|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in Kumamoto score change from baseline to 1 year.||||0.10
71068775|NCT02120833|141646775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.59|STANDARD_ERROR_OF_MEAN|4.71||0.2409|TWO_SIDED|95.0|-3.88|15.07||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||15.07|-3.88|0.2409
71112736|NCT00294671|141732714|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in mBMI change from baseline to 2 years.||||0.21
71112737|NCT00294671|141732714|SUPERIORITY_OR_OTHER|||||||0.43|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in mBMI change from baseline to 1 year.||||0.43
71112738|NCT00294671|141732715|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in SF-36 physical component change from baseline to 2 years.||||0.001
71112739|NCT00294671|141732715|SUPERIORITY_OR_OTHER|||||||0.06|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in SF-36 physical component change from baseline to 1 year.||||0.06
71068776|NCT02120833|141646776|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
71068777|NCT02120833|141646776|SUPERIORITY_OR_OTHER|||||||0.2386|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.2386
71112740|NCT00294671|141732716|SUPERIORITY_OR_OTHER|||||||0.06|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in SF-36 mental component change from baseline to 2 years.||||0.06
71112741|NCT00294671|141732716|SUPERIORITY_OR_OTHER|||||||0.37|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in SF-36 mental component change from baseline to 1 year.||||0.37
71112742|NCT01893411|141732723|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean difference|-0.04|||=|0.65|TWO_SIDED|95.0|-0.23|0.14|||Mixed Model Repeated Measure|||||0.14|-0.23|= 0.65
71112743|NCT01893411|141732723|SUPERIORITY_OR_OTHER_LEGACY||LS-Mean difference|-0.04|||=|0.741|TWO_SIDED|95.0|-0.26|0.18|||Mixed Model Repeated Measure|||||0.18|-0.26|= 0.741
71112744|NCT01893411|141732724|SUPERIORITY_OR_OTHER_LEGACY||LS-Mean difference|0.16|||=|0.075|TWO_SIDED|95.0|-0.02|0.34|||Mixed Model Repeated Measure|||||0.34|-0.02|= 0.075
71112745|NCT01893411|141732724|SUPERIORITY_OR_OTHER_LEGACY||LS-Mean difference|0.06|||=|0.603|TWO_SIDED|95.0|-0.16|0.27|||Mixed Model Repeated Measure|||||0.27|-0.16|= 0.603
71112746|NCT02403817|141732748|OTHER|This is a small pilot study with no power calculations required (and no data upon which to base a priori power estimates).||||||5e-05|||||||t-test, 2 sided|||This analysis compares pre-intervention to post-intervention scores in the eye movement training group on the primary attention outcome measure. The hand movement Control in this pilot was not feasible and the sample is too small for analysis. This is a small pilot study and so power analyses were not computed. The null hypothesis was no difference between pre- and post-training outcome measure (alpha .05).||||0.00005
71112747|NCT02403817|141732749|OTHER|||||||0.018|||||||t-test, 2 sided|||This analysis compares pre-intervention to post-intervention scores in the eye movement training group on the primary eye movement outcome measure. The hand movement Control in this pilot was not feasible and the sample is too small for analysis. This is a small pilot study and so power analyses were not computed. The null hypothesis was no difference between pre- and post-training outcome measure (alpha .05).||||0.018
71112748|NCT03053440|141732750|SUPERIORITY||Risk Difference (RD)|10.2||||0.0921|TWO_SIDED|95.0|-1.5|22.0|||Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel test stratified by the stratification factors per interactive response technology (IRT). p value is 2-sided||||22.0|-1.5|0.0921
71112749|NCT01701362|141732772|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.16||0.1823||95.0|-0.54|0.1|||Mixed Model Repeated Measures Analysis|Mixed Model Repeated Measures = MMRM|MMRM analysis includes fixed categorical effects of treatment, country, trauma type, visit week, treatment-by-visit interaction, and fixed continuous effect of baseline value. Missing mean pain scores imputed by multiple imputation method|||0.10|-0.54|0.1823
71112750|NCT01701362|141732773|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012||||||The p-value is derived from CMH test, stratified for pooled center and trauma type and excludes missing values.|Cochran-Mantel-Haenszel|||||||0.0012
71112751|NCT01701362|141732774|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.14||0.0119||95.0|-0.62|-0.08|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 1||-0.08|-0.62|0.0119
71112752|NCT01701362|141732774|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.14||0.0135||95.0|-0.62|-0.07|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 2||-0.07|-0.62|0.0135
71112753|NCT01701362|141732774|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.14||0.0028||95.0|-0.69|-0.14|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 3||-0.14|-0.69|0.0028
71112754|NCT01701362|141732774|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.14||0.0016||95.0|-0.72|-0.17|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 4||-0.17|-0.72|0.0016
71068778|NCT02120833|141646776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.3|STANDARD_ERROR_OF_MEAN|3.98||0.0241|TWO_SIDED|95.0|1.28|17.32||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||17.32|1.28|0.0241
71068779|NCT02120833|141646777|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
71068780|NCT02120833|141646777|SUPERIORITY_OR_OTHER|||||||0.0696|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0696
71068781|NCT02120833|141646777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.99|STANDARD_ERROR_OF_MEAN|4.23||0.0394|TWO_SIDED|95.0|0.46|17.52||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||17.52|0.46|0.0394
71068782|NCT02120833|141646778|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
71068783|NCT02120833|141646778|SUPERIORITY_OR_OTHER|||||||0.0772|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0772
71068784|NCT02120833|141646778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.48|STANDARD_ERROR_OF_MEAN|3.54||0.0213|TWO_SIDED|95.0|1.33|15.63||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||15.63|1.33|0.0213
71068785|NCT02120833|141646779|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
71068786|NCT02120833|141646779|SUPERIORITY_OR_OTHER|||||||0.0172|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0172
71068787|NCT02120833|141646779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.56|STANDARD_ERROR_OF_MEAN|3.48||0.1968|TWO_SIDED|95.0|-2.46|11.58||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||11.58|-2.46|0.1968
71068788|NCT02120833|141646780|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
71068789|NCT02120833|141646780|SUPERIORITY_OR_OTHER|||||||0.0712|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0712
71068790|NCT02120833|141646780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.43|STANDARD_ERROR_OF_MEAN|3.34||0.0313|TWO_SIDED|95.0|0.7|14.15||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||14.15|0.70|0.0313
71068791|NCT02805179|141646841|SUPERIORITY|Compared to historical controls||||||0.03|||||||1-sided binomial test|||||||0.03
71068792|NCT00688662|141646884|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-15.6||||0.01|TWO_SIDED|95.0|-28.0|-3.3||The primary analysis was conducted using a logistic regression model with treatment group as the factor of interest and clinical center and PSH status as covariates. A Wald test using a two-tailed significance level of 0.0499 was conducted.|Regression, Logistic|Adjusted and unadjusted risk differences with two-sided 95% confidence intervals are reported in the manuscript.|The unadjusted risk difference and confidence interval was -14.3% (-27.3%, -1.2%).|The trial was designed to test for an overall absolute difference of at least 30% in the primary outcome ('success') in patients treated with sphincterotomy compared to those treated with sham. Using a 2:1 allocation, an assumed 10% non-adherence rate, and one interim analysis for efficacy using O'Brien and Fleming boundaries and futility using conditional power, the study required 214 patients to be randomized to ensure greater than 90% likelihood of identifying this difference.||-3.3|-28.0|0.01
71068793|NCT00688662|141646885|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-9.0|||||TWO_SIDED|95.0|-24.1|5.9||A confidence interval approach was used for examining this outcome.||||Only patients with abnormal manometry were included in this subgroup analysis.||5.9|-24.1|
71068794|NCT01729338|141646909|SUPERIORITY_OR_OTHER|||||||0.45||||||Compared baseline to 3 months|paired t-test|||||||0.45
71068795|NCT01729338|141646909|SUPERIORITY_OR_OTHER|||||||0.19|||||||paired t-test|compares baseline to month 5||||||0.19
71068796|NCT01729338|141646910|SUPERIORITY_OR_OTHER|||||||0.1||||||baseline, 3 month|paired t-test|||||||0.1
71068797|NCT01729338|141646910|SUPERIORITY_OR_OTHER|||||||0.09|||||||paired t-test|baseline, month 5||||||0.09
71068798|NCT03467217|141646923|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.95|TWO_SIDED|95.0|-30.6|32.7|||ANCOVA|Adjusted for baseline value of ALT.||||32.7|-30.6|.95
71068799|NCT03467217|141646924|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.56|TWO_SIDED|95.0|-11.0|6.0|||ANCOVA|Adjusted for baseline value of GGT.||||6.0|-11.0|0.56
70941977|NCT00088452|141384311|SUPERIORITY||Odds Ratio (OR)|3.04|||<|0.001|TWO_SIDED|95.0|1.69|5.49|||Chi-squared||Percentage of subjects with a Confidence Index score of 0.60 or higher in the valproic acid group than in the lamotrigine group|||5.49|1.69|<0.001
70941978|NCT00088452|141384312|SUPERIORITY||Odds Ratio (OR)|3.08|||<|0.001|TWO_SIDED|95.0|1.81|5.33|||Fisher Exact||Odds ratio for FFF for ethosuximide versus lamotrigine|||5.33|1.81|<0.001
71068800|NCT03467217|141646925|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.53|TWO_SIDED|95.0|-10.3|19.8|||ANCOVA|Adjusted for the baseline AST value.||||19.8|-10.3|0.53
71068801|NCT03467217|141646926|SUPERIORITY||Mean Difference (Final Values)|8.4||||0.57|TWO_SIDED|95.0|-20.8|37.5|||ANCOVA|Adjusted for the baseline ALT value.||||37.5|-20.8|0.57
71068802|NCT03467217|141646927|SUPERIORITY|Adjusted for the baseline ALT value.|Mean Difference (Final Values)|11.6||||0.25|TWO_SIDED|95.0|9.7|36.7|||ANCOVA|||||36.7|9.7|0.25
71068803|NCT03467217|141646928|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.05|TWO_SIDED|95.0|0.0|6.8|||ANCOVA|Adjusted for the baseline HOMA-IR value.||||6.8|0.0|0.05
71068804|NCT03467217|141646929|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.64|TWO_SIDED|95.0|-1.5|2.5|||ANCOVA|Adjusted for the baseline weight value.||||2.5|-1.5|0.64
71068805|NCT03467217|141646930|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.98|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|Adjusted for the baseline BMI value.||||0.6|-0.6|0.98
71068806|NCT03467217|141646931|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.1|TWO_SIDED|95.0|-0.5|5.3|||ANCOVA|Adjusted for the baseline waist circumference value.||||5.3|-0.5|0.10
71068807|NCT03467217|141646932|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.08|TWO_SIDED|95.0|0.0|0.05|||ANCOVA|Adjusted for the baseline waist-to-hip ratio.||||0.05|0.00|0.08
71068808|NCT03467217|141646933|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.29|TWO_SIDED|95.0|-2.8|9.0|||ANCOVA|Adjusted for the baseline PedsQOL Physical Health score.||||9.0|-2.8|0.29
71068809|NCT03467217|141646934|SUPERIORITY|||||||0.17|||||||Exact conditional binomial test|||||||0.17
71068810|NCT03467217|141646935|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.64|TWO_SIDED|95.0|-13.9|8.7|||ANCOVA|Adjusted for baseline total cholesterol value.||||8.7|-13.9|0.64
71068811|NCT03467217|141646936|SUPERIORITY||Mean Difference (Final Values)|7.0||||0.67|TWO_SIDED|95.0|-25.6|39.7|||ANCOVA|Adjusted for baseline triglyceride value.||||39.7|-25.6|0.67
71068812|NCT03467217|141646937|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.45|TWO_SIDED|95.0|-3.4|1.5|||ANCOVA|Adjusted for baseline HDL cholesterol value.||||1.5|-3.4|0.45
71068813|NCT03467217|141646938|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.93|TWO_SIDED|95.0|-10.3|9.4|||ANCOVA|Adjusted for baseline LDL cholesterol value.||||9.4|-10.3|0.93
71068814|NCT03467217|141646939|SUPERIORITY||Median Difference (Final Values)|2.9||||0.29|TWO_SIDED|95.0|-2.5|20.1|||ANCOVA|Adjusted for baseline PedsQOL Psychosocial Health score.||||20.1|-2.5|0.29
71068815|NCT03233529|141646942|SUPERIORITY||Least Squares Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-3.1|-1.7|||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.7|-3.1|<0.0001
71068816|NCT03233529|141646943|SUPERIORITY||Least Squares Mean Difference|-0.9906|STANDARD_ERROR_OF_MEAN|0.48404||0.042|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.0420
71068817|NCT03233529|141646944|SUPERIORITY||Least Squares Mean Difference|-0.5446|STANDARD_ERROR_OF_MEAN|0.37855||0.1519|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.1519
71068818|NCT03233529|141646945|SUPERIORITY||Least Squares Mean Difference|-1.1273|STANDARD_ERROR_OF_MEAN|0.32552||0.0007|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.0007
71068819|NCT03233529|141646946|SUPERIORITY||Least Squares Mean Difference|-0.7612|STANDARD_ERROR_OF_MEAN|0.44266||0.0871|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.0871
71068820|NCT03233529|141646947|SUPERIORITY||Least Squares Mean Difference|-1.3641|STANDARD_ERROR_OF_MEAN|0.48603||0.0055|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.0055
71068821|NCT03233529|141646948|SUPERIORITY||Least Squares Mean Difference|-1.1246|STANDARD_ERROR_OF_MEAN|0.49359||0.0238|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.0238
71068822|NCT03233529|141646949|SUPERIORITY||Least Squares Mean Difference|-1.9913|STANDARD_ERROR_OF_MEAN|0.68659||0.0042|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.0042
71068823|NCT03233529|141646956|SUPERIORITY||Least Squares Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-2.7|-1.4|||Mixed Models Analysis|||Crisaborole 2% was superior to vehicle if p-value was \<0.05.||-1.4|-2.7|< 0.0001
70941979|NCT00088452|141384312|SUPERIORITY||Odds Ratio (OR)|2.88|||<|0.001|TWO_SIDED|95.0|1.68|5.02|||Fisher Exact||odds ratio for FFF for valproic acid versus lamotrigine|||5.02|1.68|<0.001
71068824|NCT03233529|141646957|SUPERIORITY||Least Square Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.3|-0.6|||Mixed Models Analysis||Comparison at Day 8|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.6|-1.3|< 0.0001
71112755|NCT01701362|141732774|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14||0.0007||95.0|-0.75|-0.2|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 5||-0.20|-0.75|0.0007
71112756|NCT01701362|141732774|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14||0.0006||95.0|-0.76|-0.21|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 6||-0.21|-0.76|0.0006
71112757|NCT01701362|141732774|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14||0.0008||95.0|-0.75|-0.2|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 7||-0.20|-0.75|0.0008
70941980|NCT02081196|141384319|OTHER||Mean Difference (Net)|4.13|STANDARD_DEVIATION|2.45|||TWO_SIDED|95.0|3.08|4.77|||||Treatment Effect =Control Flank Change-Treated Flank Change such (a positive results indicates treated area had a larger reduction in fat thickness than control area, and a negative result indicates that a greater reduction was seen in control area).|H0: μ(Control - Treated) \< +1 versus H1: μ(Control - Treated) \> +1||4.77|3.08|
71112758|NCT01701362|141732774|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.14||0.0003||95.0|-0.79|-0.24|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 8||-0.24|-0.79|0.0003
71112759|NCT01701362|141732774|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.14||0.0001||95.0|-0.82|-0.26|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 9||-0.26|-0.82|0.0001
71112760|NCT01701362|141732774|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.14||0.0005||95.0|-0.77|-0.22|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 10||-0.22|-0.77|0.0005
71112761|NCT01701362|141732774|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14||0.0007||95.0|-0.76|-0.2|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 11||-0.20|-0.76|0.0007
71112762|NCT01701362|141732774|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.14||0.0001||95.0|-0.82|-0.27|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 12||-0.27|-0.82|0.0001
71112763|NCT01701362|141732774|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.84|-0.28|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 13||-0.28|-0.84|<0.0001
71112764|NCT01701362|141732774|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.14||0.0005||95.0|-0.78|-0.22|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 14||-0.22|-0.78|0.0005
71112765|NCT01701362|141732774|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.15||0.0031||95.0|-0.71|-0.14|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 15||-0.14|-0.71|0.0031
71112766|NCT01701362|141732774|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.12||0.0001||95.0|-0.71|-0.23|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Overall||-0.23|-0.71|0.0001
71112767|NCT01701362|141732775|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.16||0.005||95.0|-0.77|-0.14|||ANCOVA|This secondary endpoint has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||||-0.14|-0.77|0.0050
71112768|NCT01701362|141732776|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.16||0.0168||95.0|-0.7|-0.07|||ANCOVA|This secondary endpoint has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||||-0.07|-0.70|0.0168
71112769|NCT01701362|141732777|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.037||0.6841||95.0|-0.09|0.06|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for mobility||0.06|-0.09|0.6841
71112770|NCT01701362|141732777|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.029||0.6564||95.0|-0.07|0.04|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for self-care||0.04|-0.07|0.6564
71112771|NCT01701362|141732777|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.043||0.859||95.0|-0.08|0.09|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for usual activities||0.09|-0.08|0.8590
71112772|NCT01701362|141732777|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.043||0.1628||95.0|-0.14|0.02|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for pain/discomfort||0.02|-0.14|0.1628
71112773|NCT01701362|141732777|SUPERIORITY_OR_OTHER_LEGACY||leaset squares mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.037||0.4654||95.0|-0.05|0.1|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for anxiety/depression||0.10|-0.05|0.4654
71112774|NCT01701362|141732777|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.017||0.5||95.0|-0.02|0.04|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for Dolan 1997 Index score||0.04|-0.02|0.5000
71112775|NCT01701362|141732777|SUPERIORITY_OR_OTHER_LEGACY||leaset squares mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.026||0.5493||95.0|-0.07|0.04|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for Dolan 2001 Index Score||0.04|-0.07|0.5493
71112776|NCT01701362|141732779|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|3.5|STANDARD_ERROR_OF_MEAN|1.8||0.0545||95.0|-0.07|7.0|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Sleep Disturbance Score||7.00|-0.07|0.0545
71068825|NCT03233529|141646957|SUPERIORITY||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.4|-0.8|||Mixed Models Analysis||Comparison at Day 15|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.8|-1.4|< 0.0001
71068826|NCT03233529|141646958|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.36||0.0188|TWO_SIDED|95.0|-1.6|-0.1|||Mixed Models Analysis||Comparison at Day 2|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.1|-1.6|0.0188
71068827|NCT03233529|141646958|SUPERIORITY||Least-Square Mean of Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.36||0.0014|TWO_SIDED|95.0|-1.9|-0.4|||Mixed Models Analysis||Comparison at Day 3|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.4|-1.9|0.0014
71068828|NCT03233529|141646958|SUPERIORITY||Least-Square Mean of Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.36||0.0003|TWO_SIDED|95.0|-2.0|-0.6|||Mixed Models Analysis||Comparison at Day 4|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.6|-2.0|0.0003
71068829|NCT03233529|141646958|SUPERIORITY||Least-Square Mean of Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.2|-0.8|||Mixed Models Analysis||Comparison at Day 5|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.8|-2.2|< 0.0001
71112777|NCT01701362|141732779|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-2.0|STANDARD_ERROR_OF_MEAN|2.29||0.3913||95.0|-6.47|2.54|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Sleep Adequancy Score||2.54|-6.47|0.3913
71068830|NCT03233529|141646958|SUPERIORITY||Least-Square Mean of Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.36||0.0003|TWO_SIDED|95.0|-2.0|-0.6|||Mixed Models Analysis||Comparison at Day 6|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.6|-2.0|0.0003
71068831|NCT03233529|141646958|SUPERIORITY||Least-Square Mean of Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.3|-0.8|||Mixed Models Analysis||Comparison at Day 7|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.8|-2.3|< 0.0001
71068832|NCT03233529|141646958|SUPERIORITY||Least-Square Mean of Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.5|-1.1|||Mixed Models Analysis||Comparison at Day 8|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.1|-2.5|< 0.0001
71068833|NCT03233529|141646958|SUPERIORITY||Least-Square Mean of Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.6|-1.2|||Mixed Models Analysis||Comparison at Day 9|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.2|-2.6|< 0.0001
71068834|NCT03233529|141646958|SUPERIORITY||Least-Square Mean of Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.7|-1.3|||Mixed Models Analysis||Comparison at Day 10|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.3|-2.7|< 0.0001
71068835|NCT03233529|141646958|SUPERIORITY||Least-Square Mean of Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.37|<|0.0001|TWO_SIDED|95.0|-2.3|-0.9|||Mixed Models Analysis||Comparison at Day 11|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.9|-2.3|< 0.0001
71068836|NCT03233529|141646958|SUPERIORITY||Least-Square Mean of Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.9|-1.5|||Mixed Models Analysis||Comparison at Day 12|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.5|-2.9|< 0.0001
71068837|NCT03233529|141646958|SUPERIORITY||Least-Square Mean of Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.6|-1.2|||Mixed Models Analysis||Comparison at Day 13|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.2|-2.6|< 0.0001
71068838|NCT03233529|141646958|SUPERIORITY||Least-Square Mean of Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.4|-1.0|||Mixed Models Analysis||Comparison at Day 14|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.0|-2.4|< 0.0001
71068839|NCT03233529|141646958|SUPERIORITY||Least-Square Mean of Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.7|-1.2|||Mixed Models Analysis||Comparison at Day 15|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.2|-2.7|< 0.0001
71068840|NCT01177293|141646961|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUC\[0- ∞\] of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted geometric means ratio|89.78|||||TWO_SIDED|90.0|82.74|97.43||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1155 on the natural log scale for AUCinf with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1234 for loge AUCinf.||97.43|82.74|
71068841|NCT01177293|141646962|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUClast of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted geometric mean ratio|99.73|||||TWO_SIDED|90.0|85.1|116.87||||||||116.87|85.10|
71068842|NCT01177293|141646963|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed Cmax of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted geometric means ratio|86.67|||||TWO_SIDED|90.0|79.57|94.42||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1278 on the natural log scale for Cmax with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1366 for loge Cmax.||94.42|79.57|
71112778|NCT01701362|141732779|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-1.1|STANDARD_ERROR_OF_MEAN|2.04||0.6059||95.0|-5.06|2.96|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Snoring Score||2.96|-5.06|0.6059
71112779|NCT01701362|141732779|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|0.6|STANDARD_ERROR_OF_MEAN|1.7||0.7317||95.0|-2.76|3.93|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Awaken Short of Breath Score||3.93|-2.76|0.7317
71068843|NCT01905553|141646968|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The magnitude effect of food on the pharmacokinetic parameters was evaluated by calculating the point estimate and 90% CIs between Treatment A (test treatment, fed) and Treatment B (reference treatment, fasted).|Ratio of Geometric LS Means|0.718|||||TWO_SIDED|90.0|0.67|0.77||||||||0.770|0.670|
71068844|NCT01905553|141646969|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The magnitude effect of food on the pharmacokinetic parameters was evaluated by calculating the point estimate and 90% CIs between Treatment A (test treatment, fed) and Treatment B (reference treatment, fasted).|Ratio of Geometric LS Means|0.718|||||TWO_SIDED|90.0|0.67|0.769||||||||0.769|0.670|
71068845|NCT01905553|141646970|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The magnitude effect of food on the pharmacokinetic parameters was evaluated by calculating the point estimate and 90% CIs between Treatment A (test treatment, fed) and Treatment B (reference treatment, fasted).|Ratio of Geometric LS Means|0.449|||||TWO_SIDED|90.0|0.38|0.53||||||||0.530|0.380|
71068846|NCT03854370|141646974|SUPERIORITY|||||||0.23|||||||Chi-squared|||Comparison of all four groups prior to surgical scrub.||||0.23
71068847|NCT03854370|141646974|SUPERIORITY|||||||0.31|||||||Fisher Exact|||Comparison of baby shampoo versus iodine post surgical scrub||||0.31
71068848|NCT03854370|141646974|SUPERIORITY|||||||0.35|||||||Fisher Exact|||Comparison of Chlorhexidine versus iodine post surgical scrub||||.35
71068849|NCT03854370|141646974|SUPERIORITY|||||||0.61|||||||Fisher Exact|||Comparison of chloroxynel versus iodine post surgical scrub||||.61
71068850|NCT03854370|141646975|SUPERIORITY|||||||0.59|||||||Chi-squared|||comparison of all four groups prior to surgical scrub||||.59
71068851|NCT03854370|141646975|SUPERIORITY|||||||0.05|||||||Fisher Exact|||Comparison of baby shampoo versus iodine post surgical scrub||||.05
71068852|NCT03854370|141646975|SUPERIORITY|||||||0.13|||||||Fisher Exact|||Comparison of chlorhexidine versus iodine post surgical scrub||||.13
70941981|NCT02081196|141384320|OTHER||sucess proportion|0.8476|||||TWO_SIDED|95.0|0.784|0.913|||||||Descriptive statistics (tabulation of Independent Panel Reviewer ratings) were used to analyze data.|.913|.784|
71068853|NCT03854370|141646975|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Comparison of chloroxynel versus iodine at post surgical scrub||||0.99
71068854|NCT03854370|141646976|SUPERIORITY|||||||0.45|||||||Chi-squared|||Comparison of all four groups prior to surgical scrub||||0.45
71068855|NCT03854370|141646976|SUPERIORITY|||||||0.99||||||all groups were negative for cultures|Fisher Exact|||Comparison of baby shampoo versus iodine post surgical scrub||||0.99
71068856|NCT03854370|141646976|SUPERIORITY|||||||0.99||||||All groups had negative cultures|Fisher Exact|||Comparison of chlorhexidine versus iodine at post surgical scrub||||0.99
71068857|NCT03854370|141646976|SUPERIORITY|||||||0.99||||||All groups had negative cultures|Fisher Exact|||Comparison of chloroxynel versus iodine at post surgical scrub||||0.99
71068858|NCT03854370|141646977|SUPERIORITY|||||||0.61|||||||Fisher Exact|||Comparison of baby shampoo versus iodine at post procedure||||0.61
71068859|NCT03854370|141646977|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Comparison of chlorhexidine versus iodine at post procedure||||0.99
71068860|NCT03854370|141646977|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Comparison of chloroxynel versus iodine at post procedure||||0.99
71068861|NCT03854370|141646978|SUPERIORITY|||||||0.32|||||||Fisher Exact|||Comparison of baby shampoo versus iodine at post procedure||||0.32
71068862|NCT03854370|141646978|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Comparison of chlorhexidine versus iodine at post procedure||||0.99
71068863|NCT03854370|141646978|SUPERIORITY|||||||0.5|||||||Fisher Exact|||Comparison of chloroxynel versus iodine at post procedure||||0.50
71068864|NCT03854370|141646979|SUPERIORITY|||||||0.99||||||All groups had negative cultures|Fisher Exact|||Comparison of baby shampoo versus iodine at post procedure||||0.99
71068865|NCT03854370|141646979|SUPERIORITY|||||||0.99||||||All groups had negative cultures|Fisher Exact|||comparison of chlorhexidine versus iodine at post procedure||||0.99
71068866|NCT03854370|141646979|SUPERIORITY|||||||0.99||||||All groups had negative cultures|Fisher Exact|||Comparison of chloroxynel versus iodine at post procedure||||0.99
71068867|NCT01608087|141647012|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|96.58|||||TWO_SIDED|93.93|88.54|105.35|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(T/R1) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|105.35|88.54|
71068868|NCT01608087|141647012|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|91.68|||||TWO_SIDED|93.93|83.5|100.65|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(T/R2) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|100.65|83.50|
71068869|NCT01608087|141647012|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|94.92|||||TWO_SIDED|93.93|87.14|103.4|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(R1/R2) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|103.40|87.14|
71068870|NCT01608087|141647013|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|98.96|||||TWO_SIDED|90.0|90.97|107.64|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(T/R1) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|107.64|90.97|
71068871|NCT01608087|141647013|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|91.67|||||TWO_SIDED|90.0|84.02|100.01|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(T/R2) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|100.01|84.02|
71079113|NCT03035916|141666058|OTHER|||||||0.824|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.824
71112780|NCT01701362|141732779|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.2663||95.0|-0.45|0.12|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Quantity of Sleep Score (hours)||0.12|-0.45|0.2663
71068872|NCT01608087|141647013|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|92.63|||||TWO_SIDED|90.0|85.18|100.74|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(R1/R2) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|100.74|85.18|
71068873|NCT01608087|141647014|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|101.53|||||TWO_SIDED|90.0|92.74|111.14|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(T/R1) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|111.14|92.74|
71068874|NCT01608087|141647014|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|93.25|||||TWO_SIDED|90.0|87.12|99.81|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(T/R2) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|99.81|87.12|
71068875|NCT01608087|141647014|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|91.85|||||TWO_SIDED|90.0|83.91|100.54|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(R1/R2) \* 100||Least square estimates of log-transformed PK endpoint for R1 and R2 were back transformed to original scale to get adjusted point estimator and interval estimates for the inter-subject ratio of the geometric means for treatments.|100.54|83.91|
71068876|NCT04304235|141647032|SUPERIORITY||Odds Ratio (OR)|2.22|||||TWO_SIDED|||||||||||||
71068877|NCT00712881|141647065|OTHER|||||||0.154||||||Threshold for significance at 0.05 level.|2-sided, binomial proportions|||||||0.154
71068878|NCT01369108|141647081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8|||||||ANOVA|||null hypothesis no difference in anatomic form||||0.8
71068879|NCT01369108|141647081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89|||||||ANOVA|||null hypothesis no difference in margin adaptation||||0.89
71112781|NCT01701362|141732779|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-2.1|STANDARD_ERROR_OF_MEAN|1.5||0.1562||95.0|-5.08|0.82|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Somnolence Score||0.82|-5.08|0.1562
71068880|NCT01369108|141647081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79|||||||ANOVA|||null hypothesis no difference in margin discoloration||||0.79
71068881|NCT01369108|141647081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|||||||ANOVA|||null hypothesis no difference in surface integrity||||0.18
71068882|NCT01369108|141647081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|||||||ANOVA|||null hypothesis no difference in secondary caries||||0.66
71068883|NCT01369108|141647082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.522|||||||ANOVA|||null hypothesis no difference in sensitivity to cold||||0.522
71068884|NCT01369108|141647082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.449|||||||Chi-squared|||null hypothesis no difference in biting pressure||||.449
71068885|NCT04143594|141647083|SUPERIORITY||Difference in percentage|-2.6||||0.7178|TWO_SIDED|95.0|-18.4|13.2||P-value was from the Cochran-Mantel-Haenszel (CMH) tests stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing and the B/F/TAF groups, and its 95% confidence interval (CI) were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||13.2|-18.4|0.7178
71068886|NCT04143594|141647083|SUPERIORITY||Difference in percentage|-7.1||||0.39|TWO_SIDED|95.0|-23.4|9.3||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||9.3|-23.4|0.3900
71112782|NCT01701362|141732779|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|1.7|STANDARD_ERROR_OF_MEAN|1.45||0.249||95.0|-1.18|4.53|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Sleep Problem Index (9) Score||4.53|-1.18|0.2490
71068887|NCT04143594|141647083|SUPERIORITY||Difference in percentage|-7.2||||0.3797|TWO_SIDED|95.0|-23.5|9.1||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||9.1|-23.5|0.3797
71068888|NCT04143594|141647084|SUPERIORITY||Difference in percentage|-5.5||||0.2398|TWO_SIDED|95.0|-15.9|4.8||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||4.8|-15.9|0.2398
71068889|NCT04143594|141647084|SUPERIORITY||Difference in percentage|-7.4||||0.1639|TWO_SIDED|95.0|-18.3|3.4||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||3.4|-18.3|0.1639
71068890|NCT04143594|141647084|SUPERIORITY||Difference in percentage|-5.7||||0.2307|TWO_SIDED|95.0|-16.3|4.9||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||4.9|-16.3|0.2307
71068891|NCT04143594|141647085|SUPERIORITY||Difference in percentage|-6.7||||0.3142|TWO_SIDED|95.0|-20.7|7.3||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||7.3|-20.7|0.3142
71068892|NCT04143594|141647085|SUPERIORITY||Difference in percentage|-7.2||||0.3009|TWO_SIDED|95.0|-21.3|6.8||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||6.8|-21.3|0.3009
71068893|NCT04143594|141647085|SUPERIORITY||Difference in percentage|-7.6||||0.2859|TWO_SIDED|95.0|-21.8|6.7||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||6.7|-21.8|0.2859
71068894|NCT04143594|141647086|SUPERIORITY||Difference in percentage|-7.1||||0.3686|TWO_SIDED|95.0|-23.2|9.0||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||9.0|-23.2|0.3686
70941982|NCT01231464|141384345|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.498|||<|0.0001|TWO_SIDED|95.0|-1.897|-1.009|||ANCOVA||Besides treatment, the ANCOVA analysis also adjusted for baseline, center, gender, age, and classification of AR (Intermittent Allergic Rhinitis \[IAR\] or Persistent Allergic Rhinitis \[PER\]).|||-1.009|-1.897|<0.0001
71068895|NCT04143594|141647086|SUPERIORITY||Difference in percentage|-16.5||||0.0887|TWO_SIDED|95.0|-34.0|1.0||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||1.0|-34.0|0.0887
71068896|NCT04143594|141647086|SUPERIORITY||Difference in percentage|-5.4||||0.4949|TWO_SIDED|95.0|-21.5|10.7||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||10.7|-21.5|0.4949
71068897|NCT04143594|141647087|SUPERIORITY||Difference in LSM|0.08||||0.5755|TWO_SIDED|95.0|-0.2|0.37||P-value was from analysis of variance (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in least squares means (Diff in LSM), and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.37|-0.20|0.5755
71068898|NCT04143594|141647087|SUPERIORITY||Difference in LSM|0.02||||0.8697|TWO_SIDED|95.0|-0.25|0.29||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.29|-0.25|0.8697
71068899|NCT04143594|141647087|SUPERIORITY||Difference in LSM|0.06||||0.7052|TWO_SIDED|95.0|-0.23|0.35||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.35|-0.23|0.7052
71068900|NCT04143594|141647088|SUPERIORITY||Difference in LSM|0.02||||0.8942|TWO_SIDED|95.0|-0.26|0.3||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.30|-0.26|0.8942
71068901|NCT04143594|141647088|SUPERIORITY||Difference in LSM|-0.02||||0.9058|TWO_SIDED|95.0|-0.28|0.25||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.25|-0.28|0.9058
71068902|NCT04143594|141647088|SUPERIORITY||Difference in LSM|0.04||||0.8129|TWO_SIDED|95.0|-0.27|0.35||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.35|-0.27|0.8129
71068903|NCT04143594|141647089|SUPERIORITY||Difference in LSM|0.04||||0.7864|TWO_SIDED|95.0|-0.25|0.33||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.33|-0.25|0.7864
71068904|NCT04143594|141647089|SUPERIORITY||Difference in LSM|-0.05||||0.7013|TWO_SIDED|95.0|-0.31|0.21||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.21|-0.31|0.7013
71068905|NCT04143594|141647089|SUPERIORITY||Difference in LSM|0.22||||0.2753|TWO_SIDED|95.0|-0.18|0.62||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.62|-0.18|0.2753
71068906|NCT04143594|141647090|SUPERIORITY||Difference in LSM|0.08||||0.564|TWO_SIDED|95.0|-0.19|0.34||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.34|-0.19|0.5640
71112783|NCT01701362|141732779|SUPERIORITY_OR_OTHER_LEGACY||leaet squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.0609||95.0|-0.15|0.0|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Optimal Sleep Score||0.00|-0.15|0.0609
71112784|NCT01701362|141732780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7165||||||p-values based on CMH test stratified by pooled center and trauma type, patients with unknown status at baseline or endpoint will not be included in the calculation of p-values.|Cochran-Mantel-Haenszel|||||||0.7165
71112785|NCT01701362|141732781|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.2||||0.0028||95.0|1.5|6.86|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 1||6.86|1.50|0.0028
70941983|NCT00993798|141384351|SUPERIORITY||LS Mean Difference|-1.27|STANDARD_DEVIATION|0.5||0.012|TWO_SIDED|95.0|-2.25|-0.28|||t-test in ANOVA model|||Exploratory comparison between SABER-Bupivacaine and Bupivacaine HCl not analyzed inferentially||-0.28|-2.25|0.012
71068907|NCT04143594|141647090|SUPERIORITY||Difference in LSM|-0.01||||0.9555|TWO_SIDED|95.0|-0.28|0.26||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.26|-0.28|0.9555
71068908|NCT04143594|141647090|SUPERIORITY||Difference in LSM|0.14||||0.4025|TWO_SIDED|95.0|-0.19|0.46||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.46|-0.19|0.4025
71068909|NCT04143594|141647091|SUPERIORITY||Difference in LSM|12.0||||0.7751|TWO_SIDED|95.0|-73.0|97.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||97|-73|0.7751
71068910|NCT04143594|141647091|SUPERIORITY||Difference in LSM|-2.0||||0.9549|TWO_SIDED|95.0|-79.0|75.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||75|-79|0.9549
71068911|NCT04143594|141647091|SUPERIORITY||Difference in LSM|44.0||||0.2603|TWO_SIDED|95.0|-33.0|120.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||120|-33|0.2603
71068912|NCT04143594|141647092|SUPERIORITY||Difference in LSM|-31.0||||0.4827|TWO_SIDED|95.0|-119.0|57.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||57|-119|0.4827
71068913|NCT04143594|141647092|SUPERIORITY||Difference in LSM|-12.0||||0.7963|TWO_SIDED|95.0|-106.0|81.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||81|-106|0.7963
71068914|NCT04143594|141647092|SUPERIORITY||Difference in LSM|-22.0||||0.6169|TWO_SIDED|95.0|-111.0|67.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||67|-111|0.6169
71068915|NCT04143594|141647093|SUPERIORITY||Difference in LSM|21.0||||0.6614|TWO_SIDED|95.0|-73.0|115.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||115|-73|0.6614
71068916|NCT04143594|141647093|SUPERIORITY||Difference in LSM|20.0||||0.6791|TWO_SIDED|95.0|-75.0|115.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||115|-75|0.6791
71112786|NCT01701362|141732781|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.66||||0.036||95.0|1.03|2.68|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 2||2.68|1.03|0.0360
71112787|NCT01701362|141732781|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.62||||0.0235||95.0|1.07|2.45|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 3||2.45|1.07|0.0235
71112788|NCT01701362|141732781|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.48||||0.0619||95.0|0.98|2.24|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 4||2.24|0.98|0.0619
71112789|NCT01701362|141732781|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.46||||0.0677||95.0|0.97|2.2|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 5||2.20|0.97|0.0677
71068917|NCT04143594|141647093|SUPERIORITY||Difference in LSM|27.0||||0.5563|TWO_SIDED|95.0|-65.0|120.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||120|-65|0.5563
71112790|NCT01701362|141732781|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.45||||0.0707||95.0|0.97|2.16|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 6||2.16|0.97|0.0707
71112791|NCT01701362|141732781|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.1313||95.0|0.91|2.06|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 7||2.06|0.91|0.1313
71112792|NCT01701362|141732781|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.24||||0.3072||95.0|0.82|1.86|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 8||1.86|0.82|0.3072
71112793|NCT01701362|141732781|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.19||||0.3947||95.0|0.79|1.8|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 9||1.80|0.79|0.3947
71112794|NCT01701362|141732781|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.36||||0.1462||95.0|0.9|2.05|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 10||2.05|0.90|0.1462
71112795|NCT01701362|141732781|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09||||0.6854||95.0|0.72|1.64|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 11||1.64|0.72|0.6854
71112796|NCT01701362|141732781|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.15||||0.5025||95.0|0.76|1.74|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 12||1.74|0.76|0.5025
71112797|NCT01701362|141732781|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.4908||95.0|0.76|1.76|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 13||1.76|0.76|0.4908
71112798|NCT01701362|141732781|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.19||||0.4245||95.0|0.78|1.8|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 14||1.80|0.78|0.4245
70941984|NCT00993798|141384352|SUPERIORITY||Median Difference (Final Values)|-8.0||||0.01|TWO_SIDED|95.0|-12.0|0.0|||Wilcoxon (Mann-Whitney)|||Exploratory comparison between SABER-Bupivacaine and Bupivacaine HCl not analyzed inferentially||0.0|-12.0|0.010
71068918|NCT04143594|141647094|SUPERIORITY||Difference in LSM|32.0||||0.5492|TWO_SIDED|95.0|-75.0|140.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||140|-75|0.5492
71068919|NCT04143594|141647094|SUPERIORITY||Difference in LSM|17.0||||0.722|TWO_SIDED|95.0|-80.0|115.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|Difference in LSM||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||115|-80|0.7220
71112799|NCT01701362|141732781|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.96||||0.8464||95.0|0.61|1.49|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 15||1.49|0.61|0.8464
71068920|NCT04143594|141647094|SUPERIORITY||Difference in LSM|-4.0||||0.9486|TWO_SIDED|95.0|-118.0|110.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||110|-118|0.9486
71068921|NCT00834639|141647138|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|97.36||||||90.0|93.68|101.18|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101.18|93.68|
71068922|NCT00834639|141647139|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|100.59||||||90.0|97.07|104.24|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104.24|97.07|
71068923|NCT00834639|141647140|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|100.36||||||90.0|97.35|103.46|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103.46|97.35|
71068924|NCT00282113|141647160|SUPERIORITY_OR_OTHER||||||>|0.5||95.0|||||Mixed-effects regression|||||||>0.5
71068925|NCT00282113|141647161|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
71068926|NCT00282113|141647162|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
71068927|NCT02949843|141647168|OTHER|||||||0.6|||||||Fisher Exact|||Null Hypothesis is that each arm has equal rates of smoking history.||||0.6
71068928|NCT00474201|141647169|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|Students paired, two-tailed T-test||"Null hypothesis: lopinavir-ritonavir does not alter gemfibrozil pharmacokinetics.~A sample size of 13 healthy subjects yielded 81% power to detect a clinically relevant change of 30% in gemfibrozil AUC with concomitant lopinavir-ritonavir (alpha = 0.05; beta = 0.2). Gemfibrozil pharmacokinetic parameters derived pre- and post lopinavir-ritonavir exposure (Days 1 and 14, respectively) were compared using a paired Students t test."||||<0.0001
71068929|NCT02784613|141647196|SUPERIORITY|||||||0.05||||||Differences in pre- and post-treatment scores were compared using Wilcoxon signed-rank test for non-parametric matched pairs. All tests of significance were 2-tailed. All analyses were performed in Stata®, version 13.|t-test, 2 sided|||||||0.05
71068930|NCT00746564|141647268|SUPERIORITY_OR_OTHER||percentage of recordings|100.0|||||TWO_SIDED|95.0|100.0|100.0||||||"The sensitivity was calculated for each recording and for each subject as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recordings/Total amount of time (sec) R waves were recorded on surface ECG"||100|100|
71079114|NCT03035916|141666058|OTHER|||||||0.547|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.547
71068931|NCT00746564|141647269|SUPERIORITY_OR_OTHER||percentage of clinical recordings|98.1|||||TWO_SIDED|95.0|95.7|100.0||||||"The sensitivity was calculated for each recording during the treadmill test and for each subject as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recordings/Total amount of time (sec) R waves were recorded on surface ECG"||100|95.7|
71068932|NCT00746564|141647270|SUPERIORITY_OR_OTHER||percentage of recordings|98.0|||||TWO_SIDED|95.0|95.5|100.0||||||"The sensitivity was calculated for each recording and for each subject during the hand to hand and hand to shoulder maneuvers as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recordings/Total amount of time (sec) R waves were recorded on surface ECG"||100|95.5|
71068933|NCT00746564|141647271|SUPERIORITY_OR_OTHER||percentage of recordings|98.9|||||TWO_SIDED|95.0|96.7|100.0||||||"The positive predictive value (PPV) was calculated for each recording and for each subject during the in-clinic recording at rest as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recording / Total amount of time (sec) R waves were recorded by device during in-clinic recording"||100|96.7|
71068934|NCT00746564|141647272|SUPERIORITY_OR_OTHER||percentage of recording|77.1|||||TWO_SIDED|95.0|65.9|88.4||||||"The positive predictive value (PPV) was calculated for each recording and for each subject for the in-clinic recording during the treadmill exercise as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recording / Total amount of time (sec) R waves were recorded by device during in-clinic recording"||88.4|65.9|
71068935|NCT00746564|141647273|SUPERIORITY_OR_OTHER||Percentage of recordings|85.0|||||TWO_SIDED|95.0|78.3|91.7||||||"The positive predictive value (PPV) was calculated for each recording and for each subject during Hand to Hand and Hand to Shoulder Maneuvers as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recording / Total amount of time (sec) R waves were recorded by device during in-clinic recording"||91.7|78.3|
71068936|NCT00746564|141647274|SUPERIORITY_OR_OTHER||percentage of interpretable recording|99.2|||||TWO_SIDED|95.0|98.5|100.0||||||"The proportion of recording time during which the device recording was interpretable was calculated for each weekly Patient Activator recording and for each subject as follows:~Duration (sec) of interpretable recording / Total duration of recording time (sec)"||100|98.5|
70941985|NCT00993798|141384353|SUPERIORITY|||||||0.014|||||||Log Rank|||Exploratory comparison between SABER-Bupivacaine and Bupivacaine HCl not analyzed inferentially||||0.014
71068937|NCT00746564|141647275|SUPERIORITY_OR_OTHER||percentage of interpretable recording|92.3|||||TWO_SIDED|95.0|91.9|92.6||||||"The proportion of recording time during which the device recording was interpretable for each automatically triggered/symptom driven recording and for each subject was calculated as follows:~Duration of interpretable recording / Total duration of recording time"||92.6|91.9|
71068938|NCT00746564|141647276|SUPERIORITY_OR_OTHER||percentage of inappropriate recordings|86.2|||||TWO_SIDED|95.0|79.4|91.0||||||||91.0|79.4|
71068939|NCT00746564|141647277|SUPERIORITY_OR_OTHER||percentage of inappropriate recordings|63.2|||||TWO_SIDED|95.0|48.1|76.2||||||||76.2|48.1|
71068940|NCT03226769|141647289|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.9788||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Computer Usage||||0.9788
71068941|NCT03226769|141647289|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.6571||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Reading||||0.6571
71068942|NCT03226769|141647289|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.471||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Leisure Activities||||0.4710
71068943|NCT03226769|141647289|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.736||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Social Activities||||0.7360
71068944|NCT03226769|141647289|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.4999||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Driving||||0.4999
71068945|NCT03226769|141647289|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.1159||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Outdoor Activities||||0.1159
71068946|NCT03226769|141647289|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.4567||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Frequency of Outdoor Activities||||0.4567
71068947|NCT03226769|141647289|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.3439||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Time Spent to Take Care of Eyes||||0.3439
71068948|NCT03226769|141647289|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.3331||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Bothered With Amount of Time Taking Care of Eyes||||0.3331
71068949|NCT03226769|141647289|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.4774||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Bothered by Appearance||||0.4774
71112800|NCT01701362|141732782|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.11||||0.1633||95.0|0.74|6.0|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 1||6.00|0.74|0.1633
71112801|NCT01701362|141732782|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.92||||0.0652||95.0|0.96|3.85|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 2||3.85|0.96|0.0652
71112802|NCT01701362|141732782|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.2||||0.0039||95.0|1.29|3.77|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 3||3.77|1.29|0.0039
71112803|NCT01701362|141732782|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.71||||0.0382||95.0|1.03|2.83|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 4||2.83|1.03|0.0382
71112804|NCT01701362|141732782|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.86||||0.0137||95.0|1.14|3.05|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 5||3.05|1.14|0.0137
71112805|NCT01701362|141732782|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.0693||95.0|0.97|2.49|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 6||2.49|0.97|0.0693
71112806|NCT01701362|141732782|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.68||||0.0349||95.0|1.04|2.73|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 7||2.73|1.04|0.0349
70852784|NCT01578850|141194350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.86|||<|0.001|TWO_SIDED|95.0|-9.23|-2.49|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ESR: Week 28||-2.49|-9.23|<0.001
70852785|NCT01578850|141194350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.69|||<|0.001|TWO_SIDED|95.0|-12.33|-5.05|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ESR: Week 36||-5.05|-12.33|<0.001
71068950|NCT03226769|141647290|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.5457||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Red Eyes||||0.5457
71068951|NCT03226769|141647290|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.9786||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Blurred Vision||||0.9786
71068952|NCT03226769|141647290|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.3894||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Dry Eyes||||0.3894
71068953|NCT03226769|141647290|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.0591||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Itchy Eyes||||0.0591
71068954|NCT03226769|141647290|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.1818||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Burning Eyes||||0.1818
71068955|NCT03226769|141647290|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.4284||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Gritty Eyes||||0.4284
71068956|NCT03226769|141647290|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.1051||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Painful Eyes||||0.1051
71068957|NCT03226769|141647290|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.7998||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Watery Eyes||||0.7998
71068958|NCT03226769|141647290|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.1229||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Swollen Eyelids||||0.1229
71079115|NCT03035916|141666058|OTHER|||||||0.303|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."||||0.303
71079116|NCT03035916|141666058|OTHER|||||||0.026|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."||||0.026
71079117|NCT03035916|141666058|OTHER|||||||0.002|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."||||0.002
71079118|NCT03035916|141666058|OTHER|||||||0.057|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.057
71079119|NCT03035916|141666058|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.001
71079120|NCT03035916|141666058|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.001
71079121|NCT03035916|141666058|OTHER|||||||0.069|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.069
71079122|NCT03035916|141666058|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.001
71079123|NCT03035916|141666058|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.001
71079124|NCT03035916|141666058|OTHER|||||||0.561|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.561
71068959|NCT03226769|141647290|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.3907||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Red Eyelids||||0.3907
71068960|NCT03226769|141647290|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.0336||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Crusty Eyelids||||0.0336
71068961|NCT01516008|141647299|SUPERIORITY_OR_OTHER||Mean Difference (Net)|76.35|||<|0.001|TWO_SIDED|95.0|51.0|101.7||P-value adjusted for multiple treatment group comparisons using the Hochberg method.|ANCOVA|ANCOVA model with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID48 in tapentadol IR group minus SPID48 in placebo group.|||101.7|51.0|<0.001
71068962|NCT01516008|141647299|SUPERIORITY_OR_OTHER||Mean Difference (Net)|90.6|||<|0.001|TWO_SIDED|95.0|65.1|116.1||P-value is adjusted for multiple treatment group comparisons using the Hochberg method.|ANCOVA|ANCOVA model with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID48 in tapentadol IR group minus SPID48 in placebo group.|||116.1|65.1|<0.001
71068963|NCT01516008|141647300|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value adjusted for multiple treatment group comparisons using the Hochberg method.|Log Rank|Stratified by center||||||<0.001
71068964|NCT01516008|141647300|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value adjusted for multiple treatment group comparisons using the Hochberg method.|Log Rank|Stratified by center||||||<0.001
71068965|NCT01516008|141647301|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||12 hours||||<0.001
71068966|NCT01516008|141647301|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||12 hours||||<0.001
71068967|NCT01516008|141647301|SUPERIORITY_OR_OTHER|||||||0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||24 hours||||0.001
71068968|NCT01516008|141647301|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||24 hours||||<0.001
71112807|NCT01701362|141732782|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.44||||0.1227||95.0|0.91|2.29|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 8||2.29|0.91|0.1227
71112808|NCT01701362|141732782|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.65||||0.0364||95.0|1.03|2.63|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 9||2.63|1.03|0.0364
71112809|NCT01701362|141732782|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.0667||95.0|0.97|2.49|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 10||2.49|0.97|0.0667
71068969|NCT01516008|141647301|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||48 hours||||<0.001
71068970|NCT01516008|141647301|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||48 hours||||<0.001
71068971|NCT01516008|141647301|SUPERIORITY_OR_OTHER|||||||0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||72 hours||||0.001
71068972|NCT01516008|141647301|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||72 hours||||<0.001
71068973|NCT01516008|141647302|SUPERIORITY_OR_OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||12 hours||||0.001
71068974|NCT01516008|141647302|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||12 hours||||<0.001
71068975|NCT01516008|141647302|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||24 hours||||<0.001
71068976|NCT01516008|141647302|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||24 hours||||<0.001
71068977|NCT01516008|141647302|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||48 hours||||<0.001
71068978|NCT01516008|141647302|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||48 hours||||<0.001
71068979|NCT01516008|141647302|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||72 hours||||<0.001
71068980|NCT01516008|141647302|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||72 hours||||<0.001
71068981|NCT01516008|141647303|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||12 hours||||<0.001
71068982|NCT01516008|141647303|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||12 hours||||<0.001
71068983|NCT01516008|141647303|SUPERIORITY_OR_OTHER|||||||0.021|||||||Cochran-Mantel-Haenszel|Controlling for center||24 hours||||0.021
71068984|NCT01516008|141647303|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||24 hours||||<0.001
71068985|NCT01516008|141647303|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||48 hours||||<0.001
71068986|NCT01516008|141647303|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||48 hours||||<0.001
71068987|NCT01516008|141647303|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||72 hours||||<0.001
71068988|NCT01516008|141647303|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||72 hours||||<0.001
71112810|NCT01701362|141732782|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.77||||0.0176||95.0|1.1|2.84|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 11||2.84|1.10|0.0176
71112811|NCT01701362|141732782|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.03||||0.003||95.0|1.27|3.23|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 12||3.23|1.27|0.0030
71112812|NCT01701362|141732782|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.71||||0.0256||95.0|1.07|2.74|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 13||2.74|1.07|0.0256
71112813|NCT01701362|141732782|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.66||||0.0314||95.0|1.05|2.64|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 14||2.64|1.05|0.0314
71112814|NCT01701362|141732782|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.38||||0.1889||95.0|0.85|2.21|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 15||2.21|0.85|0.1889
71068989|NCT01516008|141647304|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.52|||<|0.001|TWO_SIDED|95.0|11.1|22.0|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID12 in tapentadol IR group minus SPID12 in placebo group.|12 hours||22.0|11.1|<0.001
71112815|NCT02978157|141732788|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71112816|NCT04343534|141732881|OTHER||Mean Difference (Final Values)|0.15||||0.092|TWO_SIDED|95.0|-0.02|0.33|||t-test, 2 sided|||"SDM Process score distributions were compared to determine of the scores spanned the range of possible values, were normally distributed, had low rates of missing data, and whether there was indications of floor or ceiling effects.~we conducted independent t-tests to determine if there were differences in SDM Process scores between the two versions."||0.33|-0.02|0.092
71112817|NCT00066222|141732891|OTHER|||||||||||||||||This study was designed to detect an improvement in the 2-year overall survival rate from 47% to 60%. Using a one-group chi-square test with a one-sided significance level of 0.10, a sample of 67 patients was deemed sufficient to detect the difference between the null hypothesis (H0: P .47) and the alternative hypothesis (HA: P .60) with 80% power.|If the point estimate for two-year survival is less than or equal to 0.54815, the upper bound of the one-sided 90% confidence interval on 47%, then H0 would not be rejected and the conclusion would be that the two-year survival rate did not statistically improve from 47% under the new treatment. If the point estimate is greater than 0.54815, then H0 would be rejected and the conclusion is that the two-year survival rate did improve from 47% to 60% under the new treatment.|||
71112818|NCT00066222|141732894|OTHER||||||||||||||||||The following rule would reject the null hypothesis that the proportion of severe esophagitis was 30% with an overall significance level of 0.05: 27 or more cases of severe esophagitis among the total sample of evaluable patients.|||
71112819|NCT00066222|141732895|OTHER||||||||||||||||||The following rule would reject the null hypothesis that the proportion of treatment-related fatalities was less than or equal to 5% with an overall significance level of 0.05: 6 or more instances of treatment-related fatalities among the total sample of evaluable patients.|||
71112820|NCT02767869|141732905|SUPERIORITY_OR_OTHER_LEGACY|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
71112821|NCT02767869|141732906|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.530
71112822|NCT02767869|141732907|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034|||||||Wilcoxon (Mann-Whitney)|||||||0.034
71112823|NCT02767869|141732908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.050
71112824|NCT02767869|141732909|SUPERIORITY_OR_OTHER_LEGACY|||||||0.799|||||||Wilcoxon (Mann-Whitney)|||||||0.799
71112825|NCT02767869|141732910|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||||||0.047
71112826|NCT02767869|141732911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.878|||||||Wilcoxon (Mann-Whitney)|||||||0.878
71112827|NCT02767869|141732912|SUPERIORITY_OR_OTHER_LEGACY|||||||0.919|||||||Wilcoxon (Mann-Whitney)|||||||0.919
71112828|NCT02767869|141732913|SUPERIORITY_OR_OTHER_LEGACY|||||||0.254|||||||Wilcoxon (Mann-Whitney)|||||||0.254
71112829|NCT02767869|141732914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.347|||||||Wilcoxon (Mann-Whitney)|||||||0.347
71112830|NCT02767869|141732915|SUPERIORITY_OR_OTHER_LEGACY|||||||0.227|||||||Wilcoxon (Mann-Whitney)|||||||0.227
71112831|NCT02767869|141732916|SUPERIORITY_OR_OTHER_LEGACY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.410
71112832|NCT02767869|141732917|SUPERIORITY_OR_OTHER_LEGACY|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
71112833|NCT04301934|141732918|NON_INFERIORITY|The prevalence of UTI for the LASER group and vaginal estrogen group was calculated. Non-inferiority test using Farrington-Manning method was applied to test the risk difference against the pre-specified non-inferiority margin (20%).||||||0.034|||||||Farrington-Manning|||||||0.034
71068990|NCT01516008|141647304|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.11|||<|0.001|TWO_SIDED|95.0|13.6|24.6|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID12 in tapentadol IR group minus SPID12 in placebo group.|12 hours||24.6|13.6|<0.001
71068991|NCT01516008|141647304|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.71|||<|0.001|TWO_SIDED|95.0|23.2|46.2|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID24 in tapentadol IR group minus SPID24 in placebo group.|24 hours||46.2|23.2|<0.001
71112834|NCT03629223|141732926|EQUIVALENCE|Analysis was performed with Equivalence acceptance range for 90% confidence interval (CI) as 80.00% - 125.00%. In the below, LS-means = least squares mean.|Percentage of Ratio of Geometric LS-Mean|115.35|||||TWO_SIDED|90.0|108.55|122.58||||||||122.58|108.55|
71112835|NCT03629223|141732926|OTHER||Percentage of ratio of Geometric LS-Mean|186.37|||||TWO_SIDED|90.0|163.61|212.28||||||||212.28|163.61|
71112836|NCT03629223|141732926|OTHER||Percentage of ratio of Geometric LS-Mean|163.15|||||TWO_SIDED|90.0|146.17|182.1||||||||182.10|146.17|
71112837|NCT03629223|141732927|EQUIVALENCE|Analysis was performed with Equivalence acceptance range for 90% confidence interval (CI) as 80.00% - 125.00%.|Percentage of ratio of Geometric LS-Mean|115.34|||||TWO_SIDED|90.0|108.51|122.6||||||||122.60|108.51|
71112838|NCT03629223|141732927|OTHER||Percentage of ratio of Geometric LS-Mean|186.67|||||TWO_SIDED|90.0|163.78|212.77||||||||212.77|163.78|
71112839|NCT03629223|141732927|OTHER||Percentage of ratio of Geometric LS-Mean|163.26|||||TWO_SIDED|90.0|146.09|182.46||||||||182.46|146.09|
71112840|NCT03629223|141732928|EQUIVALENCE|Analysis was performed with equivalence acceptance range for 90% confidence interval (CI) as 80.00% - 125.00%.|Percentage of ratio of Geometric LS-Mean|113.57|||||TWO_SIDED|90.0|107.62|119.85||||||||119.85|107.62|
71068992|NCT01516008|141647304|SUPERIORITY_OR_OTHER||Mean Difference (Net)|43.04|||<|0.001|TWO_SIDED|95.0|31.5|54.6|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID24 in tapentadol IR group minus SPID24 in placebo group.|24 hours||54.6|31.5|<0.001
71112841|NCT03629223|141732928|OTHER||Percentage of ratio of Geometric LS-Mean|236.51|||||TWO_SIDED|90.0|215.69|259.34||||||||259.34|215.69|
71112842|NCT03629223|141732928|OTHER||Percentage of ratio of Geometric LS-Mean|199.61|||||TWO_SIDED|90.0|176.44|225.82||||||||225.82|176.44|
71112843|NCT00617097|141732958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.94|TWO_SIDED|95.0|-13.7|12.6|||Regression, Linear|||expected level of pain during procedure greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)||12.6|-13.7|0.94
70852786|NCT01578850|141194350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.59|||<|0.001|TWO_SIDED|95.0|-11.38|-3.8|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ESR: Week 44||-3.80|-11.38|<0.001
71068993|NCT01516008|141647304|SUPERIORITY_OR_OTHER||Mean Difference (Net)|122.32|||<|0.001|TWO_SIDED|95.0|81.8|162.9|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID72 in tapentadol IR group minus SPID72 in placebo group.|72 hours||162.9|81.8|<0.001
71068994|NCT01516008|141647304|SUPERIORITY_OR_OTHER||Mean Difference (Net)|138.57|||<|0.001||95.0|97.8|179.4|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID72 in tapentadol IR group minus SPID72 in placebo group.|72 hours||179.4|97.8|<0.001
70941986|NCT00993798|141384354|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.08||0.773|TWO_SIDED|95.0|-0.18|0.14|||ANOVA|||Exploratory comparison between SABER-Bupivacaine and Bupivacaine HCl not analyzed inferentially||0.14|-0.18|0.773
70941987|NCT01589523|141384360|EQUIVALENCE|paired t-test||||||0.342|||||||t-test, 2 sided|||||||0.342
71068995|NCT01516008|141647305|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.15|||<|0.001|TWO_SIDED|95.0|5.0|9.3|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR12 in tapentadol IR group minus TOTPAR12 in placebo group|12 hours||9.3|5.0|<0.001
71068996|NCT01516008|141647305|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.13|||<|0.001|TWO_SIDED|95.0|4.9|9.3|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR12 in tapentadol IR group minus TOTPAR12 in placebo group|12 hours||9.3|4.9|<0.001
71068997|NCT01516008|141647305|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.21|||<|0.001|TWO_SIDED|95.0|10.6|19.8|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR24 in tapentadol IR group minus TOTPAR24 in placebo group|24 hours||19.8|10.6|<0.001
70941988|NCT01589523|141384361|EQUIVALENCE|paired t-test||||||0.116|||||||t-test, 2 sided|||||||0.116
70941989|NCT01589523|141384362|EQUIVALENCE|paired t-test||||||0.065|||||||t-test, 2 sided|vitamin D||||||0.065
71068998|NCT01516008|141647305|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.54|||<|0.001|TWO_SIDED|95.0|10.9|20.2|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR24 in tapentadol IR group minus TOTPAR24 in placebo group|24 hours||20.2|10.9|<0.001
71068999|NCT01516008|141647305|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.76|||<|0.001|TWO_SIDED|95.0|24.3|45.3|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR48 in tapentadol IR group minus TOTPAR48 in placebo group|48 hours||45.3|24.3|<0.001
71069000|NCT01516008|141647305|SUPERIORITY_OR_OTHER||Mean Difference (Net)|33.6|||<|0.001|TWO_SIDED|95.0|23.0|44.2|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR48 in tapentadol IR group minus TOTPAR48 in placebo group|48 hours||44.2|23.0|<0.001
71069001|NCT01516008|141647305|SUPERIORITY_OR_OTHER||Mean Difference (Net)|56.59|||<|0.001|TWO_SIDED|95.0|39.4|73.8|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR72 in tapentadol IR group minus TOTPAR72 in placebo group|72 hours||73.8|39.4|<0.001
71069002|NCT01516008|141647305|SUPERIORITY_OR_OTHER||Mean Difference (Net)|53.48|||<|0.001|TWO_SIDED|95.0|36.2|70.8|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR72 in tapentadol IR group minus TOTPAR72 in placebo group|72 hours||70.8|36.2|<0.001
71069003|NCT01516008|141647306|SUPERIORITY_OR_OTHER||Mean Difference (Net)|23.66|||<|0.001|TWO_SIDED|95.0|16.4|30.9|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID12 in the tapentadol IR group minus SPRID12 in the placebo group|12 hours||30.9|16.4|<0.001
71069004|NCT01516008|141647306|SUPERIORITY_OR_OTHER||Mean Difference (Net)|26.24|||<|0.001|TWO_SIDED|95.0|18.9|33.6|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID12 in the tapentadol IR group minus SPRID12 in the placebo group|12 hours||33.6|18.9|<0.001
71069005|NCT01516008|141647306|SUPERIORITY_OR_OTHER||Mean Difference (Net)|49.93|||<|0.001|TWO_SIDED|95.0|34.4|65.4|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID24 in the tapentadol IR group minus SPRID24 in the placebo group|24 hours||65.4|34.4|<0.001
71069006|NCT01516008|141647306|SUPERIORITY_OR_OTHER||Mean Difference (Net)|58.58|||<|0.001|TWO_SIDED|95.0|43.0|74.2|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID24 in the tapentadol IR group minus SPRID24 in the placebo group|24 hours||74.2|43.0|<0.001
71112844|NCT00617097|141732958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.9|TWO_SIDED|95.0|-15.1|13.2|||Regression, Linear|||after speculum insertion greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)||13.2|-15.1|0.9
71112845|NCT00617097|141732958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8||||0.49|TWO_SIDED|95.0|-18.6|9.0|||Regression, Linear|||during paracervical block administration greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)||9|-18.6|0.49
71112846|NCT00617097|141732958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.0||||0.03|TWO_SIDED|95.0|-28.3|-1.7|||Regression, Linear|||after cervical dilation greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)||-1.7|-28.3|0.03
71112847|NCT00617097|141732958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.7|TWO_SIDED|95.0|-12.2|18.0|||Regression, Linear|||immediately after procedure greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)||18|-12.2|0.7
71112848|NCT00617097|141732958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1||||0.52|TWO_SIDED|95.0|-17.0|8.8|||Regression, Linear|||30 min after procedure greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)||8.8|-17|.52
71112849|NCT00617097|141732959|SUPERIORITY_OR_OTHER|||||||0.93|||||||Regression, Linear|||greater number is better (i.e., more satisfaction) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less satisfaction); maximum: 100 mm (greater satisfaction) Measured at end of study (i.e., upon clinic discharge)||||0.93
71112850|NCT00617097|141732960|SUPERIORITY_OR_OTHER|||||||0.07|||||||Chi-squared|||greater number is worse (i.e., more symptoms)||||0.07
71112851|NCT00617097|141732961|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||minor complications greater number is worse (i.e., more complications)||||1
71112852|NCT00617097|141732961|SUPERIORITY_OR_OTHER|||||||0.15|||||||Chi-squared|||serious complications||||0.15
71112853|NCT00349349|141733097|SUPERIORITY_OR_OTHER||percentage of responders|0.49|||<|0.0001|TWO_SIDED|95.3|0.39|0.6||The p value is testing the hypothesis that the response rate is equal to 15% versus the response rate is not equal to 15%.|Two-sided exact binomial test||Two-sided 95.3% exact confidence intervals were calculated based on the binomial distribution.|||0.60|0.39|<0.0001
71112854|NCT00349349|141733097|SUPERIORITY_OR_OTHER||percentage of responders|0.43|||<|0.0001|TWO_SIDED|95.3|0.33|0.53||The p value is testing the hypothesis that the response rate is equal to 15% versus the response rate is not equal to 15%.|Two-sided exact binomial test||Two sided 95.3% exact confidence intervals were calculated based on the binomial distribution.|||0.53|0.33|<0.0001
71112855|NCT00349349|141733097|SUPERIORITY_OR_OTHER||percentage of responders|0.63|||<|0.001|TWO_SIDED|95.3|0.35|0.85||The p value is testing the hypothesis that the response rate is equal to 15% versus the response rate is not equal to 15%.|Two-sided exact binomial test||Two-sided 95.3% exact confidence intervals were calculated based on the binomial distribution.|||0.85|0.35|<0.001
71112856|NCT00851890|141733183|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided \>95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.||||0.012
71112857|NCT00851890|141733183|SUPERIORITY_OR_OTHER|||||||0.071|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided \>95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.||||0.071
71069007|NCT01516008|141647306|SUPERIORITY_OR_OTHER||Mean Difference (Net)|111.12|||<|0.001||95.0|76.3|145.9|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID48 in the tapentadol IR group minus SPRID48 in the placebo group|48 hours||145.9|76.3|<0.001
71069008|NCT01516008|141647306|SUPERIORITY_OR_OTHER||Mean Difference (Net)|124.21|||<|0.001|TWO_SIDED|95.0|89.2|159.2|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID48 in the tapentadol IR group minus SPRID48 in the placebo group|48 hours||159.2|89.2|<0.001
71069009|NCT01516008|141647306|SUPERIORITY_OR_OTHER||Mean Difference (Net)|178.91|||<|0.001|TWO_SIDED|95.0|122.4|235.4|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID72 in the tapentadol IR group minus SPRID72 in the placebo group|72 hours||235.4|122.4|<0.001
71069010|NCT01516008|141647306|SUPERIORITY_OR_OTHER||Mean Difference (Net)|192.05|||<|0.001|TWO_SIDED|95.0|135.2|248.9|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID72 in the tapentadol IR group minus SPRID72 in the placebo group|72 hours||248.9|135.2|<0.001
71069011|NCT01516008|141647307|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||||||<0.001
71069012|NCT01516008|141647307|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||||||<0.001
71069013|NCT00986921|141647315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.87||||0.05|TWO_SIDED|95.0|0.0|3.0|||t-test, 1 sided|Data was not distributed normally. After log transformation, the log values were distributed normally.||||3|0|0.05
71069014|NCT00986921|141647316|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED|95.0||||A threshold value of p of 0.05 was considered significant.|Chi-squared|||The null hypothesis was that the groups would vary, with a p values of less than 0.05.||||0.49
71069015|NCT00986921|141647317|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||||||0.001
71069016|NCT02778074|141647332|SUPERIORITY||Mean Difference (Final Values)|-2.34|||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
71069017|NCT01817582|141647352|OTHER||Least square (LS) mean difference|0.3||||0.6199|TWO_SIDED|95.0|-0.7|1.3||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.||1.3|-0.7|0.6199
71069018|NCT01817582|141647352|OTHER||LS mean difference|0.1||||0.807|TWO_SIDED|95.0|-0.9|1.2||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.||1.2|-0.9|0.8070
71069019|NCT01817582|141647352|OTHER||LS mean difference|-0.1||||0.8068|TWO_SIDED|95.0|-1.1|0.9||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.||0.9|-1.1|0.8068
71069020|NCT01817582|141647353|OTHER||LS mean difference|-4.4||||0.2296|TWO_SIDED|95.0|-11.6|2.8||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.||2.8|-11.6|0.2296
71069021|NCT01817582|141647353|OTHER||LS mean difference|-4.9||||0.189|TWO_SIDED|95.0|-12.3|2.5||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.||2.5|-12.3|0.1890
71069022|NCT01817582|141647353|OTHER||LS mean difference|-0.5||||0.8836|TWO_SIDED|95.0|-7.7|6.7||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.||6.7|-7.7|0.8836
71069023|NCT03963232|141647373|SUPERIORITY||LS Mean Difference|-1.82|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.32|-1.32|||Mixed Models Analysis|||||-1.32|-2.32|<.0001
71069024|NCT03963232|141647374|SUPERIORITY||Odds Ratio (OR)|2.674|||<|0.0001|TWO_SIDED|95.0|2.01|3.557|||GLIMMIX|||30% responder||3.557|2.010|<.0001
71069025|NCT03963232|141647374|SUPERIORITY||Odds Ratio (OR)|2.481|||<|0.0001|TWO_SIDED|95.0|1.869|3.293|||GLIMMIX|||50% responder||3.293|1.869|<.0001
71069026|NCT03963232|141647374|SUPERIORITY||Odds Ratio (OR)|2.824|||<|0.0001|TWO_SIDED|95.0|2.007|3.972|||GLIMMIX|||75% responder||3.972|2.007|<.0001
71069027|NCT03963232|141647374|SUPERIORITY||Odds Ratio (OR)|3.309|||<|0.0001|TWO_SIDED|95.0|1.989|5.504|||GLIMMIX|||100% responder||5.504|1.989|<.0001
71069028|NCT03963232|141647375|SUPERIORITY||LS Mean Difference|7.07|STANDARD_DEVIATION|0.95|<|0.0001|TWO_SIDED|95.0|5.2|8.95|||Mixed Models Analysis|||||8.95|5.20|<.0001
71069029|NCT03963232|141647376|SUPERIORITY||LS Mean Difference|-1.78|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-2.25|-1.31|||Mixed Models Analysis|||||-1.31|-2.25|<.0001
71069030|NCT03963232|141647377|SUPERIORITY||LS Mean Difference|-1.82|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-2.35|-1.29|||Mixed Models Analysis|||||-1.29|-2.35|<.0001
71069031|NCT03963232|141647378|SUPERIORITY||Odds Ratio (OR)|3.04|||<|0.0001|TWO_SIDED|95.0|1.92|4.81|||Regression, Logistic|||||4.81|1.92|<.0001
71069032|NCT03963232|141647379|SUPERIORITY||LS Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.15|-0.62|||Mixed Models Analysis|||||-0.62|-1.15|<.0001
71069033|NCT03963232|141647380|SUPERIORITY||LS Mean Difference|-18.88|STANDARD_ERROR_OF_MEAN|2.2|<|0.0001|TWO_SIDED|95.0|-23.21|-14.56|||Mixed Models Analysis|||||-14.56|-23.21|<.0001
71112858|NCT00851890|141733183|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided \>95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.||||0.140
70852787|NCT01578850|141194350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.32|||<|0.001|TWO_SIDED|95.0|-10.03|-2.6|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ESR: Week 52||-2.60|-10.03|<0.001
71069034|NCT03963232|141647381|SUPERIORITY||LS Mean Difference|-19.24|STANDARD_ERROR_OF_MEAN|2.29|<|0.0001|TWO_SIDED|95.0|-23.73|-14.75|||Mixed Models Analysis|||||-14.75|-23.73|<.0001
71069035|NCT03963232|141647382|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|-0.22|-0.1|||Mixed Models Analysis|||||-0.10|-0.22|<.0001
71069036|NCT03963232|141647383|SUPERIORITY||LS Mean Difference|-0.224|STANDARD_ERROR_OF_MEAN|0.1021||0.0284|TWO_SIDED|95.0|-0.43|-0.02|||ANCOVA|||||-0.02|-0.43|0.0284
71069037|NCT03963232|141647384|SUPERIORITY||LS Mean Difference|-12.429|STANDARD_ERROR_OF_MEAN|3.2484||0.0001|TWO_SIDED|95.0|-18.81|-6.05|||ANCOVA|||||-6.05|-18.81|0.0001
71069038|NCT00356135|141647392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.91|||<|0.0001||95.0|-19.1|-8.73|||ANOVA|Treatment and study sites are fixed effects and MPA right before the randomization treatment period is a covariate in the model.|Mean Difference is for Prasugrel 10/10 mg arm minus Clopidogrel 75/75 mg arm.|||-8.73|-19.10|<0.0001
70852788|NCT02744040|141194415|OTHER|||||||0.048||||||Multiple hypothesis testing was performed using Tukey's Honest Significant Difference (HSD) procedure.|Mixed Effects Models|||Total HIV DNA at the time of ART initiation in each of the three EDDI groups||||0.048
71069039|NCT00356135|141647392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.98|||<|0.0001||95.0|-19.26|-8.71|||ANCOVA|||||-8.71|-19.26|<0.0001
71069040|NCT00356135|141647393|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.4||||0.4055|TWO_SIDED|95.0|-8.22|3.35||P-value for 2 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||3.35|-8.22|0.4055
71069041|NCT00356135|141647393|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-23.0|||<|0.0001|TWO_SIDED|95.0|-29.3|-17.51||P-value for 2 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-17.51|-29.30|<0.0001
71069042|NCT00356135|141647393|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.2||||0.068|TWO_SIDED|95.0|-8.82|0.32||P-value for 24 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||0.32|-8.82|0.0680
71069043|NCT00356135|141647393|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-29.0|||<|0.0001|TWO_SIDED|95.0|-33.2|-23.94||P-value for 24 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|Comparison of MPA to 20 uM ADP at 24 hours||-23.94|-33.20|<0.0001
71069044|NCT00356135|141647393|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-15.0|||<|0.0001|TWO_SIDED|95.0|-19.96|-9.65||P-value for 1 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-9.65|-19.96|<0.0001
71069045|NCT00356135|141647393|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-15.0|||<|0.0001|TWO_SIDED|95.0|-19.87|-9.32||P-value for 1 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-9.32|-19.87|<0.0001
71069046|NCT00356135|141647393|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-15.0|||<|0.0001|TWO_SIDED|95.0|-20.3|-9.22||P-value for 2 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-9.22|-20.30|<0.0001
71069047|NCT00356135|141647393|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-15.0|||<|0.0001|TWO_SIDED|95.0|-20.59|-9.22||P-value for 2 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-9.22|-20.59|<0.0001
71112859|NCT00851890|141733184|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided \>95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.||||0.008
71112860|NCT00851890|141733184|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided \>95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.||||0.003
71112861|NCT00851890|141733184|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided \>95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.||||0.009
71112862|NCT00851890|141733191|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Day 28 time point.||||0.018
71069048|NCT00356135|141647393|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.4||||0.5501|TWO_SIDED|95.0|-5.85|3.14||P-value for 2 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||3.14|-5.85|0.5501
71069049|NCT00356135|141647393|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-17.0|||<|0.0001|TWO_SIDED|95.0|-21.55|-12.37||P-value for 2 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-12.37|-21.55|<0.0001
71069050|NCT00356135|141647393|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.1||||0.0752|TWO_SIDED|95.0|-8.58|0.42||P-value for 24 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||0.42|-8.58|0.0752
71069051|NCT00356135|141647393|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-20.0|||<|0.0001|TWO_SIDED|95.0|-24.81|-15.64||P-value for 24 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-15.64|-24.81|<0.0001
71069052|NCT00356135|141647393|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-12.0|||<|0.0001|TWO_SIDED|95.0|-17.21|-7.5||P-value for 1 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-7.50|-17.21|<0.0001
71069053|NCT00356135|141647393|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-11.0|||<|0.0001|TWO_SIDED|95.0|-15.79|-5.79||P-value for 1 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-5.79|-15.79|<0.0001
71069054|NCT00356135|141647393|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-13.0|||<|0.0001|TWO_SIDED|95.0|-17.41|-7.72||P-value for 2 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-7.72|-17.41|<0.0001
71069055|NCT00356135|141647393|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-12.0|||<|0.0001|TWO_SIDED|95.0|-16.8|-6.82||P-value for 2 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-6.82|-16.80|<0.0001
71069056|NCT00356135|141647394|SUPERIORITY_OR_OTHER|||||||0.1824|||||||t-test, 2 sided|||The mean of MPA 20 uM ADP at the end of Clopidogrel open label of patients on chronic clopidogrel at the time of qualifying events was compared to the mean MPA of patients not using clopidogrel at this time.||||0.1824
71069057|NCT00356135|141647394|SUPERIORITY_OR_OTHER|||||||0.1101|||||||F-test|||The variance of MPA 20 uM ADP at the end of Clopidogrel open label of patients on chronic clopidogrel at the time of qualifying events was compared to the variance of MPA for patients not using clopidogrel at this time.||||0.1101
71069058|NCT00356135|141647395|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.1||||0.3466|TWO_SIDED|95.0|-9.5|3.37||P-value for 2 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||3.37|-9.50|0.3466
71069059|NCT00356135|141647395|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-27.0|||<|0.0001|TWO_SIDED|95.0|-33.4|-20.33||P-value for 2 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-20.33|-33.40|<0.0001
71069060|NCT00356135|141647395|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.3||||0.0127|TWO_SIDED|95.0|-13.04|-1.6||P-value for 24 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-1.60|-13.04|0.0127
71069061|NCT00356135|141647395|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-34.0|||<|0.0001|TWO_SIDED|95.0|-39.99|-28.42||P-value for 24 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-28.42|-39.99|<0.0001
70852789|NCT02744040|141194416|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in total HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for Total HIV DNA.||||<0.0001
71079125|NCT03035916|141666058|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.001
71079126|NCT03035916|141666058|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.001
71079127|NCT03035916|141666059|OTHER|||||||0.249|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.249
71079128|NCT03035916|141666059|OTHER|||||||0.091|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.091
71079129|NCT03035916|141666059|OTHER|||||||0.493|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.493
71079130|NCT03035916|141666059|OTHER|||||||0.067|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."||||0.067
71079131|NCT03035916|141666059|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."||||0.001
71079132|NCT03035916|141666059|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."||||0.001
71079133|NCT03035916|141666059|OTHER|||||||0.079|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.079
71079134|NCT03035916|141666059|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.001
71079135|NCT03035916|141666059|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.001
71079136|NCT03035916|141666059|OTHER|||||||0.314||||||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."|t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.314
71079137|NCT03035916|141666059|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.001
71069062|NCT00356135|141647395|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-18.0|||<|0.0001|TWO_SIDED|95.0|-25.58|-11.09||P-value for 1 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-11.09|-25.58|<0.0001
71069063|NCT00356135|141647395|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-20.0|||<|0.0001|TWO_SIDED|95.0|-27.09|-12.26||P-value for 1 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-12.26|-27.09|<0.0001
71069064|NCT00356135|141647395|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-22.0|||<|0.0001|TWO_SIDED|95.0|-28.42|-14.77||P-value for 2 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-14.77|-28.42|<0.0001
71069065|NCT00356135|141647395|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-23.0|||<|0.0001|TWO_SIDED|95.0|-29.61|-15.63||P-value for 2 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-15.63|-29.61|<0.0001
71069066|NCT00356135|141647395|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.6||||0.4954|TWO_SIDED|95.0|-3.11|6.38||P-value for 2 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||6.38|-3.11|0.4954
71069067|NCT00356135|141647395|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-11.0|||<|0.0001|TWO_SIDED|95.0|-15.92|-6.24||P-value for 2 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-6.24|-15.92|<0.0001
71069068|NCT00356135|141647395|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.3||||0.1971|TWO_SIDED|95.0|-8.31|1.74||P-value for 24 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||1.74|-8.31|0.1971
71069069|NCT00356135|141647395|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-16.0|||<|0.0001|TWO_SIDED|95.0|-20.98|-10.75||P-value for 24 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-10.75|-20.98|<0.0001
71069070|NCT00356135|141647395|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-13.0|||<|0.0001|TWO_SIDED|95.0|-18.81|-7.32||P-value for 1 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-7.32|-18.81|<0.0001
71069071|NCT00356135|141647395|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-12.0||||0.0001|TWO_SIDED|95.0|-17.91|-6.09||P-value for 1 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-6.09|-17.91|0.0001
71069072|NCT00356135|141647395|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-11.0|||<|0.0001|TWO_SIDED|95.0|-15.64|-6.32||P-value for 2 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-6.32|-15.64|<0.0001
71079138|NCT03035916|141666059|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.001
71069073|NCT00356135|141647395|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-9.9|||<|0.0001|TWO_SIDED|95.0|-14.67|-5.09||P-value for 2 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-5.09|-14.67|<0.0001
71069074|NCT00356135|141647396|SUPERIORITY_OR_OTHER|||||||0.0005||95.0||||P-value for MPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient|||||||0.0005
71069075|NCT00356135|141647396|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for RPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient|||||||<0.0001
71069076|NCT00356135|141647396|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||P-value for MPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient|||||||0.0150
71069077|NCT00356135|141647396|SUPERIORITY_OR_OTHER|||||||0.0152||95.0||||P-value for RPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient|||||||0.0152
71069078|NCT00356135|141647396|SUPERIORITY_OR_OTHER|||||||0.0153||95.0||||P-value for MPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient|||||||0.0153
71069079|NCT00356135|141647396|SUPERIORITY_OR_OTHER|||||||0.0018||95.0||||P-value for RPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient|||||||0.0018
71069080|NCT05270395|141647433|SUPERIORITY||Odds Ratio (OR)|8.02||||0.02|TWO_SIDED|95.0|1.38|46.69|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||46.69|1.38|0.02
71069081|NCT05270395|141647434|SUPERIORITY||Odds Ratio (OR)|1.35||||0.63|TWO_SIDED|95.0|0.4|4.56|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||4.56|0.40|0.63
71069082|NCT05270395|141647435|SUPERIORITY||Odds Ratio (OR)|0.29||||0.13|TWO_SIDED|95.0|0.06|1.46|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||1.46|0.06|0.13
71112863|NCT00851890|141733191|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Day 28 time point.||||0.020
71069083|NCT05270395|141647436|SUPERIORITY||Odds Ratio (OR)|0.54||||0.4|TWO_SIDED|95.0|0.13|2.24|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||2.24|0.13|0.40
71069084|NCT05270395|141647437|SUPERIORITY||Odds Ratio (OR)|2.22||||0.29|TWO_SIDED|95.0|0.51|9.62|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||9.62|0.51|0.29
71069085|NCT05270395|141647438|SUPERIORITY||Odds Ratio (OR)|3.55||||0.07|TWO_SIDED|95.0|0.88|14.32|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||14.32|0.88|0.07
71069086|NCT05270395|141647439|SUPERIORITY||Odds Ratio (OR)|3.93||||0.09|TWO_SIDED|95.0|0.82|18.89|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||18.89|0.82|0.09
71069087|NCT05270395|141647440|SUPERIORITY||Odds Ratio (OR)|1.73||||0.42|TWO_SIDED|95.0|0.46|6.43|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||6.43|0.46|0.42
71112864|NCT00851890|141733191|SUPERIORITY_OR_OTHER|||||||0.054|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Day 28 time point.||||0.054
71112865|NCT00851890|141733191|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Final Visit time point.||||0.010
71112866|NCT00851890|141733191|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Final Visit time point.||||0.005
71112867|NCT00851890|141733191|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Final Visit time point.||||0.014
71112868|NCT00851890|141733192|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.026
70852790|NCT02744040|141194416|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in total HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for Total HIV DNA.||||<0.0001
71069088|NCT05270395|141647441|SUPERIORITY||Odds Ratio (OR)|2.86||||0.08|TWO_SIDED|95.0|0.87|9.42|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||9.42|0.87|0.08
71069089|NCT05270395|141647442|SUPERIORITY||Odds Ratio (OR)|8.29||||0.004|TWO_SIDED|95.0|1.99|34.49|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||34.49|1.99|0.004
71069090|NCT00970632|141647455|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.1||||0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 endpoint between tadalafil and placebo treatment groups was for the primary comparison and assessed for significance at a level of 0.05.|ANCOVA|||||||0.001
71069091|NCT00970632|141647455|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5||||0.023||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tamsulosin and placebo treatment groups was secondary in nature and assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.023
71069092|NCT00970632|141647456|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.2|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 4 between tadalafil and placebo treatment groups was assessed for significance at a level of 0.05.|ANCOVA|||||||<0.001
71069093|NCT00970632|141647456|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.3|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 4 between tamsulosin and placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||<0.001
71112869|NCT00851890|141733192|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.026
71112870|NCT00851890|141733192|SUPERIORITY_OR_OTHER|||||||0.138|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.138
71112871|NCT00851890|141733193|SUPERIORITY_OR_OTHER|||||||0.209|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.209
71112872|NCT00851890|141733193|SUPERIORITY_OR_OTHER|||||||0.473|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.473
71069094|NCT00970632|141647457|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.055||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.055
71112873|NCT00851890|141733193|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.031
71112874|NCT00851890|141733194|SUPERIORITY_OR_OTHER|||||||0.209|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.209
71069095|NCT00970632|141647457|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.055||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.055
71069096|NCT00970632|141647458|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||<0.001
71069097|NCT00970632|141647458|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.026||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.026
71069098|NCT00970632|141647459|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.08||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.080
71112875|NCT00851890|141733194|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||1.000
71112876|NCT03135431|141733197|NON_INFERIORITY|\<=.5g/dl difference in the decrease in hemoglobin was considered equivalent as 1 unit of blood typically raises the hemoglobin by 1g/dl and would be a clinical significant difference.|Mean Difference (Final Values)|-0.04121||||0.08|ONE_SIDED|95.0||0.0712|||t-test, 1 sided|||Assuming that a difference of 0.5 g/dl in the drop in hemoglobin between study arms would be considered as equivalent, and assuming a common standard deviation of 1.1 based on previous studies of cesarean deliveries deliveries , the study would have 80% power to test for non-inferiority with 60 participants in each arm (120 total).|Based on new data from a retrospective study preformed at Mayo Clinic sites an additional power calculation was preformed. Based on the new information, our study was well powered (84%) to assess our primary aim with 38 participants (18 salpingectomy, 20 BTL); therefore, we discontinued recruitment and completed the study with the accrued subjects.|.0712||0.08
71112877|NCT03135431|141733198|SUPERIORITY||Mean Difference (Final Values)|-11.21|||||TWO_SIDED|95.0|-14.1|-8.3|||||Evidence to suggest salpingecotomy procedure had a longer operation time than a tubal ligation.|||-8.3|-14.1|
71112878|NCT03135431|141733199|SUPERIORITY||Mean Difference (Net)|-9.17||||0.77|TWO_SIDED|95.0|-72.5|54.17|||t-test, 2 sided|||Analysis preformed as categorical and categorical variable. Both analyzes had the same conclusion.||54.17|-72.5|0.77
71112879|NCT00375674|141733202|SUPERIORITY||Cox Proportional Hazard|0.761||||0.03|TWO_SIDED|95.0|0.594|0.975|||Cox Proportional hazards model|Based on the Cox Proportional hazards model stratified by UISS High-Risk Group.||Superiority analysis||0.975|0.594|0.030
71112880|NCT00375674|141733203|SUPERIORITY||Cox Proportional Hazard|0.811||||0.077|TWO_SIDED|95.0|0.643|1.023|||Cox Proportional hazards model|Based on the Cox Proportional hazards model stratified by UISS High-Risk Group||Superiority analysis||1.023|0.643|0.077
71112881|NCT00375674|141733204|SUPERIORITY||Hazard Ratio (HR)|0.929||||0.661|TWO_SIDED|95.0|0.67|1.289|||Log-rank test|||Hazard ratio was based on the Cox Proportional hazards model stratified by UISS High-Risk Group.||1.289|0.670|0.661
71112882|NCT03744910|141733213|OTHER||Treatment difference|-2.75|STANDARD_ERROR_OF_MEAN|1.563|||TWO_SIDED|95.0|-5.84|0.35||||||||0.35|-5.84|
71112883|NCT03430843|141733252|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0001|TWO_SIDED|95.0|0.57|0.85|||1-sided, Log Rank Test|||||0.85|0.57|0.0001
71112884|NCT00443872|141733298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5|STANDARD_DEVIATION|1.0|<|0.01|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Comparison of mean group scores at baseline and 12 weeks||||<0.01
71112885|NCT00443872|141733299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|||<|0.01|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.01
71112886|NCT00443872|141733300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|||<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided||Comparison of baseline vs. 3 month circumference of the Left and Right lower leg/ankle (change identical for both legs).|Change in pedal edema as measured by change in lower leg/ankle circumference in the left and right legs||||<0.01
71112887|NCT00443872|141733301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
71112888|NCT00443872|141733302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This analysis is for the Activities of Daily Living (ADL) section of the scale||||<0.01
71112889|NCT00443872|141733302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2|||<|0.05|TWO_SIDED|||||This analysis is for the motor section of the UPDRS|Wilcoxon (Mann-Whitney)|||||||<0.05
71112890|NCT00443872|141733303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
71112891|NCT00443872|141733304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71112892|NCT00443872|141733305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71112893|NCT00443872|141733306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71112894|NCT00135330|141733307|SUPERIORITY_OR_OTHER|||||||0.282||95.0|||||ANCOVA|||The ratio of the ASI-iAUC at Week 20 to that at baseline was compared between the treatment groups.||||0.282
71112895|NCT00135330|141733308|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANCOVA|||||||0.004
71112896|NCT00135330|141733309|SUPERIORITY_OR_OTHER|||||||0.308||95.0|||||ANCOVA|||||||0.308
71112897|NCT00135330|141733310|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||ANCOVA|||||||0.079
71112898|NCT00135330|141733311|SUPERIORITY_OR_OTHER|||||||0.252||95.0|||||ANCOVA|||||||0.252
71112899|NCT00135330|141733312|SUPERIORITY_OR_OTHER|||||||0.465||95.0|||||ANCOVA|||||||0.465
71112900|NCT00135330|141733313|SUPERIORITY_OR_OTHER|||||||0.348||95.0|||||ANCOVA|||||||0.348
71112901|NCT00135330|141733317|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Mixed Model Repeated Measures (MMRM)|||||||0.039
71112902|NCT00135330|141733318|SUPERIORITY_OR_OTHER|||||||0.555||95.0|||||MMRM|||||||0.555
71112903|NCT00135330|141733320|SUPERIORITY_OR_OTHER|||||||0.106||95.0|||||MMRM|||||||0.106
71112904|NCT00135330|141733321|SUPERIORITY_OR_OTHER|||||||0.341||95.0|||||MMRM|||||||0.341
71112905|NCT00135330|141733322|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||MMRM|||||||<0.001
71112906|NCT00135330|141733323|SUPERIORITY_OR_OTHER|||||||0.276||95.0|||||MMRM|||||||0.276
71112907|NCT00135330|141733324|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||MMRM|||||||0.840
71112908|NCT00135330|141733325|SUPERIORITY_OR_OTHER|||||||0.096||95.0|||||MMRM|||||||0.096
71112909|NCT00135330|141733326|SUPERIORITY_OR_OTHER|||||||0.875||95.0|||||MMRM|||||||0.875
71112910|NCT00135330|141733327|SUPERIORITY_OR_OTHER|||||||0.581||95.0|||||ANCOVA|||||||0.581
71112911|NCT00135330|141733328|SUPERIORITY_OR_OTHER|||||||0.631||95.0|||||ANCOVA|||||||0.631
71112912|NCT00135330|141733329|SUPERIORITY_OR_OTHER|||||||0.724||95.0|||||ANCOVA|||||||0.724
71112913|NCT00135330|141733330|SUPERIORITY_OR_OTHER|||||||0.117||95.0|||||MMRM|||||||0.117
71112914|NCT00135330|141733331|SUPERIORITY_OR_OTHER|||||||0.251||95.0|||||MMRM|||||||0.251
71112915|NCT00135330|141733332|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||MMRM|||||||0.710
71112916|NCT00135330|141733333|SUPERIORITY_OR_OTHER|||||||0.575||95.0|||||Fisher Exact|||||||0.575
71112917|NCT00135330|141733334|SUPERIORITY_OR_OTHER|||||||0.436||95.0|||||ANOVA|||||||0.436
71112918|NCT00135330|141733335|SUPERIORITY_OR_OTHER|||||||0.168||95.0|||||Generalized Linear Model|||||||0.168
71112919|NCT00104416|141733351|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|31.6|||<|0.0001||95.0|15.8|48.1|||Cochran-Mantel-Haenszel|||||48.1|15.8|<0.0001
71112920|NCT01309997|141733374|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
71112921|NCT01309997|141733374|SUPERIORITY_OR_OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
71112922|NCT03462641|141733375|SUPERIORITY||t-value|-2.15|STANDARD_DEVIATION|1.32||0.0407|TWO_SIDED|||||Alpha was set to 0.05.|Paired-Sample Two-Tailed T-Test|||Null hypothesis was no difference in PIGD score within participants before and after flumazenil infusion.||||0.0407
71112923|NCT03462641|141733375|OTHER||F-value|2.861||||0.103|TWO_SIDED|||||"P value is given for the Drug\*Time term, which represents interaction between time relative to administration (before infusion vs after infusion) and treatment administered (placebo vs flumazenil).~Alpha was set to 0.05."|Repeated Measures ANCOVA|||Null hypothesis is that there is no significant interaction between drug and time of administration (pre vs. post infusion).||||0.103
71117746|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.45||||0.455|TWO_SIDED|95.0|-8.89|19.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||19.79|-8.89|0.455
71069099|NCT00970632|141647459|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.118||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.118
71069100|NCT00970632|141647460|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.022||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.022
71069101|NCT00970632|141647460|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.546||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 endpoint between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.546
71069102|NCT00970632|141647461|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5||||0.003||||||The p-value associated with LS Mean difference of changes from baseline to Week 1 between tadalafil and placebo treatment groups was assessed for significance at a level of 0.05.|ANCOVA|||||||0.003
71069103|NCT00970632|141647461|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5||||0.005||||||The p-value associated with LS Mean difference of changes from baseline to Week 1 between tamsulosin and placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.005
71069104|NCT00970632|141647462|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 4 between tadalafil and placebo treatment groups was assessed for significance at a level of 0.05.|ANCOVA|||||||<0.001
71069105|NCT00970632|141647462|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 4 between tamsulosin and placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||<0.001
71069106|NCT00970632|141647463|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.003||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil and placebo treatment groups was assessed for significance at a level of 0.05.|ANCOVA|||||||0.003
71069107|NCT00970632|141647463|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.026||95.0||||The p-value associated with LS Mean difference of changes from baseline to Week 12 endpoint between tamsulosin and placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.026
71069108|NCT00970632|141647464|SUPERIORITY_OR_OTHER|||||||0.001||||||The p-value associated with difference between tadalafil versus placebo treatment groups within the 7 response categories was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|Cochran-Mantel-Haenszel|Analysis used data only from these treatment arms and stratification of baseline LUTS severity (moderate \[total IPSS \<20\]; severe \[total IPSS ≥20\]).||||||0.001
71069109|NCT00970632|141647464|SUPERIORITY_OR_OTHER|||||||0.114||95.0||||The p-value associated with difference between tamsulosin versus placebo treatment groups within the 7 response categories was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|Cochran-Mantel-Haenszel|Analysis used data only from these treatment arms and stratification of baseline LUTS severity (moderate \[total IPSS \<20\]; severe \[total IPSS ≥20\]).||||||0.114
71069110|NCT00970632|141647465|SUPERIORITY_OR_OTHER|||||||0.004||||||The p-value associated with difference between tadalafil versus placebo treatment groups within the 7 response categories was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|Cochran-Mantel-Haenszel|Analysis used data only from these treatment arms and a stratification of baseline LUTS severity (moderate \[total IPSS \<20\]; severe \[total IPSS ≥20\]).||||||0.004
71069111|NCT00970632|141647465|SUPERIORITY_OR_OTHER|||||||0.452||||||The p-value associated with difference between tamsulosin versus placebo treatment groups within the 7 response categories was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|Cochran-Mantel-Haenszel|Analysis used data only from these treatment arms and stratification of baseline LUTS severity (moderate \[total IPSS \<20\]; severe \[total IPSS ≥20\]).||||||0.452
71079139|NCT03035916|141666059|OTHER|||||||0.087|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.087
71079140|NCT03035916|141666059|OTHER|||||||0.023|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.023
71079141|NCT03035916|141666059|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.001
71079142|NCT03035916|141666060|OTHER|||||||0.384|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.384
71079143|NCT03035916|141666060|OTHER|||||||0.53|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.530
71079144|NCT03035916|141666060|OTHER|||||||0.819|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.819
71079145|NCT03035916|141666060|OTHER|||||||0.108|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."||||0.108
71079146|NCT03035916|141666060|OTHER|||||||0.667|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."||||0.667
71079147|NCT03035916|141666060|OTHER|||||||0.046|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."||||0.046
71069112|NCT00970632|141647466|SUPERIORITY_OR_OTHER||Median of Treatment Group Differences|-4.4||||0.005||||||The p-value associated with the testing for differences in medians between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|Van Elteren Tests|P-values testing for differences of medians between placebo and active treatment were based on the Van Elteren test, stratifying by region.||||||0.005
71069113|NCT00970632|141647466|SUPERIORITY_OR_OTHER||Median of Treatment Group Differences|-2.2||||0.457||||||The p-value associated with the testing for differences in medians between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 without adjustments for multiplicity.|Van Elteren Tests|P-values testing for differences of medians between placebo and active treatment were based on the Van Elteren test, stratifying by region.||||||0.457
71079148|NCT03035916|141666060|OTHER|||||||0.006|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."||||0.006
71079149|NCT03035916|141666060|OTHER|||||||0.406|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."||||0.406
71079150|NCT03035916|141666060|OTHER|||||||0.042|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."||||0.042
71079151|NCT03035916|141666060|OTHER|||||||0.655|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."||||0.655
71079152|NCT03035916|141666060|OTHER|||||||0.262|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."||||0.262
71079153|NCT03035916|141666060|OTHER|||||||0.143|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."||||0.143
71079154|NCT03035916|141666060|OTHER|||||||0.494|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."||||0.494
71079155|NCT03035916|141666060|OTHER|||||||0.001|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."||||0.001
71112924|NCT03462641|141733376|OTHER||Standardized β Coefficient|0.6||||2.9e-07|TWO_SIDED|95.0|0.13|1.07||P value presented is for model comparison between interaction model and random intercept model.|Mixed Models Analysis|||A pair of maximum likelihood mixed linear models were estimated. The first was a random intercept model that merely accounted for individual differences in PIGD score before infusion. The second was an interaction model, that added an interaction term between baseline FMZ PET binding and PIGD score change from pre to post infusion. The interaction model was compared against the random intercept model to determine significance of the interaction using likelihood ratio goodness of fit test.||1.07|0.13|0.00000029
71112925|NCT03517371|141733454|SUPERIORITY||Mean Difference (Final Values)|72.35||||0.89|TWO_SIDED|95.0|-943.34|1088.04|||t-test, 2 sided|||||1088.04|-943.34|.89
71112926|NCT03517371|141733455|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.42|TWO_SIDED|95.0|-3.8|3.1|||t-test, 2 sided|||||3.10|-3.80|.42
71112927|NCT03517371|141733456|SUPERIORITY||Median Difference (Final Values)|2.17||||0.85|TWO_SIDED|95.0|-20.64|24.97|||t-test, 2 sided|Levene's test significant, equal variances not assumed values reported.||||24.97|-20.64|.85
71112928|NCT03517371|141733457|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.824|TWO_SIDED|95.0|-0.081|0.065|||t-test, 2 sided|||||.065|-.081|.824
71112929|NCT04283656|141733467|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.76|1.24||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment A (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate alone)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for doravirine AUC falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.24|0.76|
71112930|NCT04283656|141733468|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|0.93|||||TWO_SIDED|90.0|0.66|1.32||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment A (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate alone)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for doravirine Cmax falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.32|0.66|
71112931|NCT04283656|141733469|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.76|1.24||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment A (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate alone)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for doravirine C24 falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.24|0.76|
71117674|NCT01559259|141740589|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21|||<|0.001|TWO_SIDED|95.0|0.13|0.35||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||0.35|0.13|<0.001
71117675|NCT01559259|141740589|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.25|||<|0.001|TWO_SIDED|95.0|0.15|0.41||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 400 mg - placebo), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||0.41|0.15|<0.001
71117676|NCT01559259|141740589|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.12||||0.549|TWO_SIDED|95.0|0.77|1.63||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||1.63|0.77|0.549
71117677|NCT01559259|141740589|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.97||||0.863|TWO_SIDED|95.0|0.66|1.42||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||1.42|0.66|0.863
71112932|NCT04283656|141733470|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|1.17|||||TWO_SIDED|90.0|0.91|1.5||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment A (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate alone)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for tenofovir AUC falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.50|0.91|
71112933|NCT04283656|141733471|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|1.38|||||TWO_SIDED|90.0|0.73|2.6||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment A (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate alone)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for tenofovir Cmax falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||2.60|0.73|
71112934|NCT04283656|141733472|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|1.14|||||TWO_SIDED|90.0|0.93|1.4||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment A (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate alone)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for tenofovir C24 falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.40|0.93|
71112935|NCT04283656|141733473|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.7|1.35||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment B (Single-dose estradiol and spironolactone co-administered with placebo)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for estradiol AUC falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.35|0.70|
71117678|NCT01559259|141740589|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.86||||0.454|TWO_SIDED|95.0|0.57|1.28||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||1.28|0.57|0.454
71028481|NCT04128007|141564460|SUPERIORITY||Odds Ratio (OR)|9.46|||<|0.0001|TWO_SIDED|95.0|4.81|18.61||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Cochran-Mantel-Haenszel||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|PSSI-75 at Week 8 Odds Ratio||18.61|4.81|<0.0001
71028482|NCT04128007|141564461|SUPERIORITY||Odds Ratio (OR)|34.45|||<|0.0001|TWO_SIDED|95.0|8.49|139.77|||Cochran-Mantel-Haenszel|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|PSSI-90 at Week 8 Odds Ratio||139.77|8.49|<0.0001
71028483|NCT00950807|141564526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|||<|0.001|TWO_SIDED|95.0|0.06|0.196|||Mixed Models Analysis|||||0.196|0.060|<0.001
71028484|NCT00950807|141564526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|||<|0.001|TWO_SIDED|95.0|0.077|0.216|||Mixed Models Analysis|||||0.216|0.077|<0.001
71028485|NCT00950807|141564526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.095||||0.006|TWO_SIDED|95.0|0.027|0.162|||Mixed Models Analysis|||||0.162|0.027|0.006
71112936|NCT04283656|141733474|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|1.12|||||TWO_SIDED|90.0|0.92|1.36||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment B (Single-dose estradiol and spironolactone co-administered with placebo)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratios for estradiol Cmax falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.36|0.92|
71112937|NCT04283656|141733475|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|1.09|||||TWO_SIDED|90.0|0.88|1.35||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment B (Single-dose estradiol and spironolactone co-administered with placebo)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratios for estradiol C12 falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.35|0.88|
71112938|NCT00394329|141733476|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.56|STANDARD_ERROR_OF_MEAN|0.28||0.066|TWO_SIDED|95.0|0.32|0.96||Hochberg adjustment was applied to the p-value to account for each of three active group comparisons to the placebo group. The unadjusted p-value is 0.033.|Regression, Cox|||||0.96|0.32|0.066
71112939|NCT04660552|141733502|EQUIVALENCE|The post treatment cars scores of active and sham group will be statistically different as measured by independent sample t-test with p\<.05|Mean Difference (Net)|7.23|STANDARD_DEVIATION|4.2||0.01|TWO_SIDED|95.0|2.357|12.107|||t-test, 2 sided|||||12.107|2.357|0.01
71112940|NCT02565147|141733511|SUPERIORITY|||||||0.7505|||||||Wilcoxon Rank Sum Test|||||||0.7505
71112941|NCT01104545|141733572|OTHER||Geometric mean ratio (GMR)|1.0|||||||||||||GMR = Fed/Fasted|||||
71112942|NCT01104545|141733573|OTHER||GMR|0.73|||||||||||||GMR = Fed/fasted|||||
71112943|NCT00289289|141733601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|4.8||0.629|ONE_SIDED|95.0||0.5||P-value is from a paired t-test since each subject had the intervention pacing features turned ON and OFF in this crossover study|t-test, 1 sided|One-sided paired t-test with 221 degrees of freedom|A mean difference greater than zero indicates an average increase in atrial fibrillation/atrial tachycardia symptomatic episodes while the intervention pacing features were programmed ON versus OFF.|Null Hypothesis: rate of symptomatic atrial tachycardia/atrial fibrillation episodes during periods when intervention pacing features ON is greater to or equal to the rate of symptomatic atrial tachycardia/atrial fibrillation episodes during periods where intervention pacing features were programmed OFF Alternative Hypothesis: rate of symptomatic AT/AF during periods of ON programming is less than the rate of symptomatic AT/AF during OFF programming||0.5||0.629
71112944|NCT00289289|141733602|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0||||0.165|||||||Wilcoxon (Mann-Whitney)|P-value is from Koch's adaptation to the Wilcoxon Rank-Sum test comparing the within subject ON minus OFF differences to 0|A negative change means an improvement in AF symptom frequency with intervention pacing therapy programmed ON. Total possible improvement while intervention features are programmed ON is -64. Total possible worsening during ON programming is 64.|"The null hypothesis is that the symptom frequency score does not differ between while intervention pacing features were programmed ON versus OFF.~This secondary objective was not powered."||||0.165
71112945|NCT00289289|141733603|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.603|TWO_SIDED|95.0|0.39|1.73||P-value is based on a repeated measures Cox proportional hazards model to the rate of AF cardioversion attempts between periods of ON and OFF programming|Regression, Cox||Hazard Ratio compares rate of first attempted cardioversion for AF while the intervention pacing features were programmed ON versus OFF.|"Null Hypothesis: AF Cardioversion attempt rate is the same during periods of ON and OFF programming~Alternative Hypothesis: AF Cardioversion attempt rate is different during periods of ON and OFF programming"||1.73|0.39|0.603
71112946|NCT00289289|141733604|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.394||95.0||||Within each randomized subject, the ON minus OFF difference in AT/AF burden was computed. The Wilcoxon Signed-Rank test was used to determine if the ON minus OFF difference in AT/AF burden was different from zero.|Wilcoxon (Mann-Whitney)||A negative median difference represents an improvement (lessening) of AT/AF burden during periods of ON versus OFF programming. A positive median difference represents an increase in AT/AF burden during ON compared to OFF programming.|Null Hypothesis: There is no difference in AT/AF burden during periods on ON and OFF programming Alternative Hypothesis: AT/AF burden is lower during periods of ON programming compared to periods of OFF programming||||0.394
71028486|NCT00950807|141564526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||<|0.001|TWO_SIDED|95.0|0.074|0.205|||Mixed Models Analysis|||||0.205|0.074|<0.001
71112947|NCT00940290|141733671|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Kruskal-Wallis|||After reading the clinical practice guideline, the median response from the four groups were compared using the Kruskal-Wallis statistic||||0.007
71112948|NCT03583359|141733696|SUPERIORITY||Difference in Responder Rate|66.8|||<|0.0001|TWO_SIDED|95.0|53.7|75.2|||Fisher's exact test|The Fisher's exact test was utilized to test the superiority of treatment (Radiesse \[+\]) over control group.|Two-sided Newcombe confidence intervals (CIs) were calculated for difference in responder rate.|||75.2|53.7|<0.0001
71112949|NCT01831466|141733702|SUPERIORITY_OR_OTHER||Difference in response rates|3.9|STANDARD_ERROR_OF_MEAN|6.36||0.5425|TWO_SIDED|80.0|-4.3|12.0|||Cochran-Mantel-Haenszel|||||12.0|-4.3|0.5425
71112950|NCT01831466|141733702|SUPERIORITY_OR_OTHER||Difference in response rates|-4.0|STANDARD_ERROR_OF_MEAN|5.87||0.4976|TWO_SIDED|80.0|-11.5|3.5|||Cochran-Mantel-Haenszel|||||3.5|-11.5|0.4976
71112951|NCT01831466|141733702|SUPERIORITY_OR_OTHER||Difference in response rates|3.3|STANDARD_ERROR_OF_MEAN|6.36||0.6039|TWO_SIDED|80.0|-4.9|11.5|||Cochran-Mantel-Haenszel|||||11.5|-4.9|0.6039
71112952|NCT01831466|141733702|SUPERIORITY_OR_OTHER||Difference in response rate|4.0|STANDARD_ERROR_OF_MEAN|6.34||0.5279|TWO_SIDED|80.0|-4.1|12.1|||Cochran-Mantel-Haenszel|||||12.1|-4.1|0.5279
71112953|NCT01831466|141733703|SUPERIORITY_OR_OTHER||Difference in response rates|10.8|STANDARD_ERROR_OF_MEAN|5.99||0.071|TWO_SIDED|80.0|3.1|18.5|||Cochran-Mantel-Haenszel|||||18.5|3.1|0.0710
71112954|NCT01831466|141733703|SUPERIORITY_OR_OTHER||Difference in response rates|-1.2|STANDARD_ERROR_OF_MEAN|5.2||0.8175|TWO_SIDED|80.0|-7.9|5.5|||Cochran-Mantel-Haenszel|||||5.5|-7.9|0.8175
71112955|NCT01831466|141733703|SUPERIORITY_OR_OTHER||Difference in response rates|11.0|STANDARD_ERROR_OF_MEAN|5.63||0.0513|TWO_SIDED|80.0|3.8|18.2|||Cochran-Mantel-Haenszel|||||18.2|3.8|0.0513
71112956|NCT01831466|141733703|SUPERIORITY_OR_OTHER||Difference in response rates|6.7|STANDARD_ERROR_OF_MEAN|5.23||0.2021|TWO_SIDED|80.0|0.0|13.4|||Cochran-Mantel-Haenszel|||||13.4|-0.0|0.2021
71112957|NCT04776720|141733734|SUPERIORITY||Model based LS mean difference|0.19||||0.743|TWO_SIDED|95.0|-0.95|1.34|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.34|-0.95|0.743
71112958|NCT04776720|141733735|SUPERIORITY||Model based LS mean difference|0.98||||0.043|TWO_SIDED|95.0|0.03|1.93|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.93|0.03|0.043
71112959|NCT04776720|141733736|SUPERIORITY||Model based LS mean difference|0.99||||0.689|TWO_SIDED|95.0|-3.87|5.84|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, with variance co-variance matrix||||5.84|-3.87|0.689
71028487|NCT00950807|141564526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|||<|0.001|TWO_SIDED|95.0|0.113|0.259|||Mixed Models Analysis|||||0.259|0.113|<0.001
71112960|NCT04776720|141733737|SUPERIORITY||Model based LS mean difference|-0.28||||0.685|TWO_SIDED|95.0|-1.63|1.07|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.07|-1.63|0.685
71028488|NCT00950807|141564526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079||||0.03|TWO_SIDED|95.0|0.008|0.151|||Mixed Models Analysis|||||0.151|0.008|0.030
71112961|NCT04776720|141733738|SUPERIORITY||Model based LS mean difference|0.3||||0.764|TWO_SIDED|95.0|-1.69|2.3|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||2.3|-1.69|0.764
71112962|NCT04776720|141733739|SUPERIORITY||Model based LS mean difference|-0.12||||0.883|TWO_SIDED|95.0|-1.78|1.53|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.53|-1.78|0.883
71112963|NCT04776720|141733740|SUPERIORITY||Model based LS mean difference|-0.11||||0.753|TWO_SIDED|95.0|-0.83|0.6|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.6|-0.83|0.753
71112964|NCT04776720|141733741|SUPERIORITY||Model based LS mean difference|-3.4||||0.276|TWO_SIDED|95.0|-9.54|2.74|||Mixed Models Analysis|Adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||2.74|-9.54|0.276
71112965|NCT04776720|141733742|SUPERIORITY||Model based LS mean difference|-0.29||||0.319|TWO_SIDED|95.0|-0.86|0.28|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.28|-0.86|0.319
71112966|NCT04776720|141733743|SUPERIORITY||Model based LS mean difference|0.1||||0.448|TWO_SIDED|95.0|-0.15|0.34|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.34|-0.15|0.448
71112967|NCT00803595|141733755|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 18 hours (h) was set to assure the superiority of laninamivir octanoate over a putative placebo. A meta-analysis using 3 placebo-controlled trials reported that the difference between the median time to illness alleviation in the placebo and oseltamivir groups was 33.1 h and the 95% confidence interval ranged from 19.1 to 47.1 h. From this, a margin that was less than the lower limit of this 95% CI was selected.|Median Difference (Final Values)|-0.6||||0.748|TWO_SIDED|95.0|-9.9|6.9||2-sided p-value without adjustments for multiple testing|Generalized Wilcoxon Test|||This trial was designed to confirm the efficacy of laninamivir octanoate by showing that the median time to illness alleviation in patients treated with laninamivir octanoate was not \>18 hours longer than that in patients treated with oseltamivir. Sample size of 300 patients in each group was determined to achieve a power of at least 80% to show noninferiority at both dose levels of laninamivir octanoate with use of a Monte Carlo simulation.||6.9|-9.9|0.748
71112968|NCT00803595|141733755|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-12.8||||0.038|TWO_SIDED|95.0|-18.2|-0.4||2-sided p-value without adjustments for multiple testing|Generalized Wilcoxon Test|||Null hypothesis was that there was no difference in the time to illness alleviation||-0.4|-18.2|0.038
71117679|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-41.07|||<|0.001|TWO_SIDED|95.0|-59.56|-22.58||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-22.58|-59.56|<0.001
71028489|NCT00950807|141564526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|||<|0.001|TWO_SIDED|95.0|0.064|0.204|||Mixed Models Analysis|||||0.204|0.064|<0.001
71028490|NCT00950807|141564526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|||<|0.001|TWO_SIDED|95.0|0.101|0.242|||Mixed Models Analysis|||||0.242|0.101|<0.001
71028491|NCT00950807|141564526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105||||0.003|TWO_SIDED|95.0|0.037|0.173|||Mixed Models Analysis|||||0.173|0.037|0.003
71028492|NCT02129348|141564531|SUPERIORITY||Treatment Effect Difference|0.7||||0.53|TWO_SIDED|95.0|-1.4|2.7||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||Lithium will significantly reduce agitation/aggression compared to placebo. In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||2.7|-1.4|0.53
71028493|NCT02129348|141564532|SUPERIORITY||Treatment Effect Difference|2.11||||0.26|TWO_SIDED|95.0|0.73|6.13||The threshold for statistical significance was p = 0.05.|Chi-squared||Odds ratio and its 95% confidence interval were computed.|Change in both NPI core score (≥30% versus \<30%) and CGI behavior change (1 or 2 versus ≥3) were required for response; these two measures were then analyzed separately. A x² test was used to identify whether there was a change in NPI core scores and CGI scores from baseline to week 12.||6.13|0.73|0.26
71069114|NCT00970632|141647467|SUPERIORITY_OR_OTHER||Difference in LS Means|4.0|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANCOVA|||||||<0.001
71069115|NCT00970632|141647467|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.699||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANCOVA|||||||0.699
71069116|NCT00970632|141647468|SUPERIORITY_OR_OTHER|||||||0.009||||||The p-value associated with median difference of changes from baseline to Week 12 endpoint between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANOVA|Analysis of variance (ANOVA) using rank transformed data.||||||0.009
71069117|NCT00970632|141647468|SUPERIORITY_OR_OTHER|||||||0.014||||||The p-value associated with median difference of changes from baseline to Week 12 endpoint between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANOVA|ANOVA using rank transformed data.||||||0.014
71069118|NCT00970632|141647471|SUPERIORITY_OR_OTHER|||||||0.303||||||The p-value associated with median difference of changes from baseline to Week 12 endpoint between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANOVA|Analysis of variance (ANOVA) using rank transformed data.||||||0.303
71079156|NCT03035916|141666060|OTHER|||||||0.001|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."||||0.001
71079157|NCT03035916|141666060|OTHER|||||||0.555|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."||||0.555
71079158|NCT03035916|141666060|OTHER|||||||0.411|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."||||0.411
71079159|NCT03035916|141666060|OTHER|||||||0.167|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."||||0.167
71079160|NCT03035916|141666060|OTHER|||||||0.445|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.445
71079161|NCT03035916|141666060|OTHER|||||||0.489|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.489
71079162|NCT03035916|141666060|OTHER|||||||0.159|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.159
71079163|NCT03035916|141666060|OTHER|||||||0.72|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.720
71079164|NCT03035916|141666060|OTHER|||||||0.026|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.026
71079165|NCT03035916|141666060|OTHER|||||||0.011|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.011
71079166|NCT03035916|141666060|OTHER|||||||0.763|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.763
71069119|NCT00970632|141647471|SUPERIORITY_OR_OTHER|||||||0.146||||||The p-value associated with median difference of changes from baseline to Week 12 endpoint between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANOVA|ANOVA using rank transformed data.||||||0.146
71069120|NCT00748189|141647480|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57|||<|0.001|TWO_SIDED|95.0|0.45|0.72|||Log Rank||Hazard ratios are obtained using the Pike estimator.|||0.72|0.45|<0.001
71069121|NCT00748189|141647483|OTHER||Hazard Ratio (HR)|0.88||||0.363|TWO_SIDED|95.0|0.65|1.17|||Log Rank||hazard ratios are obtained using the Pike estimator. A hazard ratio \<1 indicates a lower risk with O+CHL treatment compared with chlorambucil|||1.17|0.65|0.363
71069122|NCT00748189|141647496|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of dose-normalized chlorambucil Cmax values with ofatumumab in current study and without ofatumumab in prior study|Ratio of Cmax/Dose|0.71|||||TWO_SIDED|90.0|0.53|0.94|||||Ratio of Cmax/Dose is the ratio of dose-normalized chlorambucil Cmax values when given with ofatumumab in the current study and without ofatumumab in the prior study (LEUA1001).|||0.94|0.53|
71069123|NCT00748189|141647496|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of dose-normalized PAAM Cmax values with ofatumumab in current study and without ofatumumab in prior study|Ratio of Cmax/Dose|0.79|||||TWO_SIDED|90.0|0.63|0.99|||||Ratio of Cmax/Dose is the ratio of dose-normalized PAAM Cmax values when given with ofatumumab in the current study and without ofatumumab in the prior study (LEUA1001).|||0.99|0.63|
71069124|NCT00748189|141647497|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of dose-normalized chlorambucil AUC(0-6) values with ofatumumab in current study and without ofatumumab in prior study|Ratio of AUC(0-6)/Dose|1.04|||||TWO_SIDED|90.0|0.77|1.4|||||Ratio of AUC(0-6)/Dose is the ratio of dose-normalized chlorambucil AUC(0-6) values when given with ofatumumab in the current study and without ofatumumab in the prior study (LEUA1001).|||1.40|0.77|
71069125|NCT00748189|141647497|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of dose-normalized chlorambucil AUC(0-inf) values with ofatumumab in current study and without ofatumumab in prior study|Ratio of AUC(0-inf)/Dose|1.11|||||TWO_SIDED|90.0|0.82|1.5|||||Ratio of AUC(0-inf)/Dose is the ratio of dose-normalized chlorambucil AUC(0-inf) values when given with ofatumumab in the current study and without ofatumumab in the prior study (LEUA1001).|||1.50|0.82|
71069126|NCT00748189|141647497|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of dose-normalized PAAM AUC(0-6) values with ofatumumab in current study and without ofatumumab in prior study|Ratio of AUC(0-6)/Dose|0.89|||||TWO_SIDED|90.0|0.72|1.1|||||Ratio of AUC(0-6)/Dose is the ratio of dose-normalized PAAM AUC(0-6) values when given with ofatumumab in the current study and without ofatumumab in the prior study (LEUA1001).|||1.10|0.72|
71069127|NCT01424514|141647505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|-0.6|0.36||||||Placebo vs SB-705498 12 mg for 1 h in WM 0-60 TSS||0.36|-0.60|
71069128|NCT01424514|141647505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|-0.45|0.51||||||Placebo vs SB-705498 12 mg for 24 h in WM 0-60 TSS||0.51|-0.45|
71069129|NCT01424514|141647505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-0.58|0.51||||||Placebo vs SB-705498 12 mg for 1 h in Maximum TSS||0.51|-0.58|
71069130|NCT01424514|141647505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.51|0.72||||||Placebo vs SB-705498 12 mg for 24 h in Maximum TSS||0.72|-0.51|
71069131|NCT01424514|141647507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-0.3|0.54||||||Placebo vs SB-705498 12 mg for WM 0-60 TSS||0.54|-0.30|
71069132|NCT01424514|141647507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|-0.39|0.57||||||Placebo vs SB-705498 12 mg for Maximum TSS||0.57|-0.39|
71069133|NCT01424514|141647511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.14|0.08||||||Placebo vs SB-705498 12 mg for Day 1, 1 h in WM 0-60 sneezing||0.08|-0.14|
71069134|NCT01424514|141647511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.13|0.09||||||Placebo vs SB-705498 12 mg for Day 14, 1 h in WM 0-60 sneezing||0.09|-0.13|
71069135|NCT01424514|141647511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.2|0.11||||||Placebo vs SB-705498 12 mg for Day 14, 24 h in WM 0-60 sneezing||0.11|-0.20|
71069136|NCT01424514|141647511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.28|0.14||||||Placebo vs SB-705498 12 mg for Day 1, 1 h in Maximum sneezing||0.14|-0.28|
71069137|NCT01424514|141647511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|95.0|-0.15|0.13||||||Placebo vs SB-705498 12 mg for Day 14, 1 h in Maximum sneezing||0.13|-0.15|
71069138|NCT01424514|141647511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.2|0.16||||||Placebo vs SB-705498 12 mg for Day 1, 24 h in Maximum sneezing||0.16|-0.20|
71069139|NCT01424514|141647512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.026|||TWO_SIDED|95.0|-0.03|0.07||||||Placebo vs SB-705498 12 mg for Day 1, 2 h in AR||0.07|-0.03|
71069140|NCT01424514|141647512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.027|||TWO_SIDED|95.0|-0.13|-0.02||||||Placebo vs SB-705498 12 mg for Day 14, 2 h in AR||-0.02|-0.13|
71069141|NCT01424514|141647512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.031|||TWO_SIDED|95.0|-0.04|0.08||||||Placebo vs SB-705498 12 mg for Day 14, 25 h in AR||0.08|-0.04|
71069142|NCT01424514|141647513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.36|0.26||||||Placebo vs SB-705498 12 mg for Day 14 in AR||0.26|-0.36|
71069143|NCT01424514|141647514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.06|0.6||||||Placebo vs SB-705498 12 mg for Day 1, 1 h in WM 0-60 TOSS||0.60|-0.06|
71069144|NCT01424514|141647514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-0.32|0.53||||||Placebo vs SB-705498 12 mg for Day 14, 1 h in WM 0-60 TOSS||0.53|-0.32|
71069145|NCT01424514|141647514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-0.22|0.63||||||Placebo vs SB-705498 12 mg for Day 14, 24 h in WM 0-60 TOSS||0.63|-0.22|
71069146|NCT01424514|141647514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|-0.3|0.68||||||Placebo vs SB-705498 12 mg for Day 1, 1 h in Maximum TOSS||0.68|-0.30|
71069147|NCT01424514|141647514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.34|0.86||||||Placebo vs SB-705498 12 mg for Day 14, 1 h in Maximum TOSS||0.86|-0.34|
71069148|NCT01424514|141647514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-0.15|0.73||||||Placebo vs SB-705498 12 mg for Day 14, 24 h in Maximum TOSS||0.73|-0.15|
71069149|NCT02653170|141647524|SUPERIORITY||difference-in-differences (DID) p-value|0.025||||0.025|TWO_SIDED|||||P-value represents the test of the interaction term for a difference-in-differences (DID) model \[i.e., 2 degree freedom test of the interaction between intervention group\*time\]|Mixed Models Analysis|PROC MIXED MODEL including main effects of intervention group (UC, SWSCM, SWSCM+VSSP website) and time (7-day and 90-day) plus the interaction term|The DID estimates contrasting the 90-day minus 7-day differences in each group are as follows: SWSCM vs Usual Care = 0.970 (p=0.335), SWSCM+VSSP vs Usual Care = 3.370 (p\<0.001), SWSCM+VSSP vs SWSCM = 2.400 (p=0.016)|Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group \* time interaction term.||||0.025
71069150|NCT02653170|141647525|SUPERIORITY||difference-in-differences (DID) p-value|0.562||||0.562|TWO_SIDED|||||P-value represents the test of the interaction term for a difference-in-differences (DID) model \[i.e., 2 degree freedom test of the interaction between intervention group\*time\]|Mixed Models Analysis|PROC MIXED MODEL including main effects of intervention group (UC, SWSCM, SWSCM+VSSP website) and time (7-day and 90-day) plus the interaction term|The DID estimates contrasting the 90-day minus 7-day differences in each group are as follows: SWSCM vs Usual Care = -1.064 (p=0.422), SWSCM+VSSP vs Usual Care = 0.258 (p=0.844), SWSCM+VSSP vs SWSCM = 1.322 (p=0.309)|Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group \* time interaction term.||||0.562
71069151|NCT02653170|141647526|SUPERIORITY|||||||0.789||||||P-value represents the test of the interaction term for a difference-in-differences (DID) model \[i.e., 2 degree freedom test of the interaction between intervention group\*time\]|Mixed Models Analysis|||Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group \* time interaction term.||||0.789
71069152|NCT02653170|141647527|SUPERIORITY||difference-in-differences (DID) p-value|0.042||||0.042|TWO_SIDED|||||P-value represents the test of the interaction term for a difference-in-differences (DID) model \[i.e., 2 degree freedom test of the interaction between intervention group\*time\]|Mixed Models Analysis||The DID estimates contrasting the 90-day minus 7-day differences in each group are as follows: SWSCM vs Usual Care = -1.651 (p=0.558), SWSCM+VSSP vs Usual Care = 5.023 (p=0.073), SWSCM+VSSP vs SWSCM = 6.674 (p=0.016)|Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group \* time interaction term.||||0.042
71079167|NCT03035916|141666060|OTHER|||||||0.187|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.187
71069153|NCT02653170|141647528|SUPERIORITY|||||||0.993||||||P-value represents the test of the interaction term for a difference-in-differences (DID) model \[i.e., 2 degree freedom test of the interaction between intervention group\*time\]|Mixed Models Analysis|||Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group \* time interaction term.||||0.993
71069154|NCT02821338|141647541|EQUIVALENCE|90% confidence interval falls within 80.00-125.00%|Test/Reference ratio|0.9863|||||TWO_SIDED|90.0|0.9598|1.0134||||||90% confidence interval of the geometric mean ratio of test/reference||1.0134|0.9598|
71069155|NCT02821338|141647542|EQUIVALENCE|90% confidence interval falls within 80.00-125.00%|Test/Reference Ratio|0.9785|||||TWO_SIDED|90.0|0.9484|1.0095||||||||1.0095|0.9484|
71069156|NCT02821338|141647543|EQUIVALENCE|90% confidence interval falls within 80.00-125.00%|Test/Reference Ratio|1.047|||||TWO_SIDED|90.0|1.0079|1.0877||||||||1.0877|1.0079|
71112969|NCT00803595|141733755|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 18 hours was set to assure the superiority of laninamivir octanoate over a putative placebo. A meta-analysis using 3 placebo-controlled trials reported that the difference between the median time to illness alleviation in the placebo and oseltamivir groups was 33.1 h and the 95% confidence interval ranged from 19.1 to 47.1 h. From this, a margin that was less than the lower limit of this 95% CI was selected.|Median Difference (Final Values)|12.2||||0.104|TWO_SIDED|95.0|-1.5|17.2|||Generalized Wilcoxon test|||This trial was designed to confirm the efficacy of laninamivir octanoate by showing that the median time to illness alleviation in patients treated with laninamivir octanoate was not \>18 hours longer than that in patients treated with oseltamivir. Sample size of 300 patients in each group was determined to achieve a power of at least 80% to show noninferiority at both dose levels of laninamivir octanoate with use of a Monte Carlo simulation.||17.2|-1.5|0.104
71112970|NCT00803595|141733756|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.3||||0.318|TWO_SIDED|95.0|-2.8|9.1||2-sided P value without adjustments for multiple testing.|Generalized Wilcoxon test|||Null hypothesis was that there was no difference in the time for return to normal axillary temperature.||9.1|-2.8|0.318
71112971|NCT00803595|141733756|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.6||||0.981|TWO_SIDED|95.0|-5.8|5.7||2-sided P value without adjustments for multiple testing.|Generalized Wilcoxon test|||Null hypothesis was that there was no difference in the time for return to normal axillary temperature.||5.7|-5.8|0.981
71112972|NCT00803595|141733756|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.7||||0.344|TWO_SIDED|95.0|-9.1|3.1||2-sided P value without adjustments for multiple testing.|Generalized Wilcoxon test|||Null hypothesis was that there was no difference in the time for return to normal axillary temperature.||3.1|-9.1|0.344
71112973|NCT03122145|141733764|SUPERIORITY|Mann whitney U between groups comparison for voluntary cough parameters between healthy controls and individuals with ALS outcomes: peak expiratory cough flow and cough volume acceleration||||||0.0005|||||||ANOVA|||Hypothesis that voluntary cough \> reflex cough strength and effectiveness in healthy volunteers||||0.0005
71112974|NCT01597908|141733766|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.58|0.83|||||Hazard ratios are estimated using a Pike estimator.|||0.83|0.58|
71112975|NCT01597908|141733767|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.52|0.73|||||Hazard ratios are estimated using a Pike estimator.|||0.73|0.52|
71112976|NCT01597908|141733769|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.51|0.81||||||||0.81|0.51|
71069157|NCT01194999|141647549|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No significant difference from baseline to final follow-up.||||0.001
71069158|NCT03834974|141647575|SUPERIORITY||||||<|0.0286|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There would be no difference in change in intent to tan outdoors 10 or more times in the next year.||||<0.0286
71069159|NCT03834974|141647575|SUPERIORITY|||||||0.0937|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There would be no difference in change in in intent to tan later in life.||||0.0937
71069160|NCT03834974|141647579|SUPERIORITY||||||<|0.0002|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There would be no difference in tanning outside at follow-up||||<0.0002
71069161|NCT00090220|141647596|SUPERIORITY_OR_OTHER||Percent Relative Risk Reduction|88.7||||||95.0|78.1|94.8|||||Confidence Interval based on binomial tail probabilities and not from a dispersion parameter.|||94.8|78.1|
71069162|NCT00090220|141647622|SUPERIORITY_OR_OTHER||Percent Relative Risk Reduction|94.8||||||95.0|79.9|99.4|||||Confidence Interval based on binomial tail probabilities and not from a dispersion parameter.|||99.4|79.9|
71069163|NCT00090220|141647630|SUPERIORITY_OR_OTHER||Percent Relative Risk Reduction|84.7||||||95.0|67.5|93.7|||||Confidence Interval based on binomial tail probabilities and not from a dispersion parameter.|||93.7|67.5|
71069164|NCT00823043|141647645|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<.001
71112977|NCT04114071|141733778|EQUIVALENCE|An independent sample t tests was used to examine the difference score for each of the four outcome measures of interest (steps, WC, weight, and HbA1c) between intervention and control groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71112978|NCT01659996|141733779|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% confidence interval (CI) of the difference between the two proportions was \< δ for serogroup A and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|-0.11|||||TWO_SIDED|95.0|-3.11|2.93||||||Meningococcal serogroup A: The null hypothesis (H0: pm - ppm \> δ) was tested against the alternative hypothesis (H1: pm - ppm ≤ δ), where pm and ppm were the proportions of subjects in Group 1 and in Group 2, respectively, who achieved a Menactra vaccine response for meningococcal serogroups A, C, Y and W-135, with δ = 0.10.||2.93|-3.11|
71112979|NCT01659996|141733779|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% CI of the difference between the two proportions was \< δ for serogroup C and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|1.27|||||TWO_SIDED|95.0|-0.84|3.64||||||Meningococcal serogroup C: The null hypothesis (H0: pm - ppm \> δ) was tested against the alternative hypothesis (H1: pm - ppm ≤ δ), where pm and ppm were the proportions of subjects in Group 1 and in Group 2, respectively, who achieved a Menactra vaccine response for meningococcal serogroups A, C, Y and W-135, with δ = 0.10.||3.64|-0.84|
71069165|NCT00823043|141647646|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||t-test, 2 sided|||||||0.024
71069166|NCT00823043|141647647|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||t-test, 2 sided|||||||0.75
71069167|NCT00823043|141647648|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||t-test, 2 sided|||||||0.69
71069168|NCT03557931|141647660|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|1.02||0.858|TWO_SIDED|90.0|-1.51|1.88|||MMRM Method|||Mixed model repeated measures (MMRM) analysis model is performed with change from baseline (least square (LS) Mean estimate for observed value from separate model using observed values) at week 12 as response; treatment, site (pooled where necessary), visit, treatment\*visit, and visit\*baseline as fixed effects, and baseline as a covariate.|Cohen's d Effect Size was defined as: (t-value for the least squares mean pairwise difference of ASP4345 50 mg vs placebo) \* sqrt(1/n\[PLACEBO\] + 1/n\[ASP4345\]). The Cohen's d Effect Size value for ASP4345 50 mg vs placebo is 0.035.|1.88|-1.51|0.858
71069169|NCT03557931|141647660|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|90.0|-1.93|1.36|||0.775|||MMRM analysis model is performed with change from baseline (LS Mean estimate for observed value from separate model using observed values) at week 12 as response; treatment, site (pooled where necessary), visit, treatment\*visit, and visit\*baseline as fixed effects, and baseline as a covariate.|Cohen's d Effect Size was defined as: (t-value for the least squares mean pairwise difference of ASP4345 150 mg vs placebo) \* sqrt(1/n\[PLACEBO\] + 1/n\[ASP4345\]). The Cohen's d Effect Size value for ASP4345 150 mg vs placebo is - 0.053.|1.36|-1.93|
71069170|NCT03557931|141647666|SUPERIORITY||LS Mean Difference|0.75|STANDARD_ERROR_OF_MEAN|1.6||0.639|TWO_SIDED|90.0|-1.9|3.41|||ANCOVA|||Analysis of covariance (ANCOVA) model is performed with change from baseline (LS Mean estimate for observed value from separate model using observed values) at the Week 12 timepoint as response, treatment and site (pooled where necessary) and baseline as a covariate.||3.41|-1.90|0.639
71069171|NCT03557931|141647666|SUPERIORITY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|1.54||0.721|TWO_SIDED|90.0|-3.11|2.01|||ANCOVA|||ANCOVA model is performed with change from baseline (LS Mean estimate for observed value from separate model using observed values) at the Week 12 timepoint as response, treatment and site (pooled where necessary) and baseline as a covariate.||2.01|-3.11|0.721
71069172|NCT00737204|141647668|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.001
71069173|NCT00737204|141647669|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|95.0|||||ANCOVA|||Repeated measure analysis||||.01
71069174|NCT00737204|141647670|SUPERIORITY_OR_OTHER||||||>=|0.805||95.0|||||Paired t-tests|||Null hypothesis: CD4 levels for both the Armodafinil and Placebo groups will not change significantly between baseline and week 4.||||>=.805
71069175|NCT02989649|141647722|OTHER||Least Square Mean (LSM)|-1.25|STANDARD_ERROR_OF_MEAN|0.098|<|0.001|TWO_SIDED|95.0|-1.44|-1.05|||Regression, Linear||The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.|Statistical analysis for data at Baseline compared to the data at Month 6||-1.05|-1.44|<0.001
71069176|NCT02989649|141647723|OTHER|||||||0.423|||||||Regression, Linear|||Statistical analysis for subgroup: Prior therapy of diabetes mellitus, Ever used or Never used||||0.423
71069177|NCT02989649|141647723|OTHER|||||||0.747|||||||Regression, Linear|||Statistical analysis for subgroup: Sex, Male or Female||||0.747
71069178|NCT02989649|141647723|OTHER||||||<|0.001|||||||Regression, Linear|||Statistical analysis for subgroup: Age, \<45 or \>=45 to \<65 years or \>=65 years||||<0.001
71069179|NCT02989649|141647723|OTHER|||||||0.99|||||||Regression, Linear|||Statistical analysis for subgroup: Cardiovascular risk group, Yes or No||||0.990
71069180|NCT02989649|141647723|OTHER|||||||0.841|||||||Regression, Linear|||Statistical analysis for subgroup: Therapy type, Monotherapy or Combined therapy||||0.841
71069181|NCT02989649|141647723|OTHER|||||||0.847|||||||Regression, Linear|||Statistical analysis for subgroup: Baseline BMI, \<25 or 25 to \<30 or \>=30 kg/m\^2||||0.847
71069182|NCT02989649|141647723|OTHER||||||<|0.001|||||||Regression, Linear|||Statistical analysis for subgroup: Initial glycemic control, \<7% or \>=7%||||<0.001
71069183|NCT02989649|141647726|OTHER||Least Square Mean (LSM)|-0.95|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-1.29|-0.62|||||The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.|Statistical analysis for data at Baseline compared to the data at Month 3||-0.62|-1.29|
71069184|NCT02989649|141647726|OTHER||Least Square Mean (LSM)|-0.87|STANDARD_ERROR_OF_MEAN|0.245|||TWO_SIDED|95.0|-1.36|-0.39|||||The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.|Statistical analysis for data at Baseline compared to the data at Month 6||-0.39|-1.36|
71069185|NCT02989649|141647727|OTHER||Least Square Mean (LSM)|-0.95|STANDARD_ERROR_OF_MEAN|0.117|||TWO_SIDED|95.0|-1.18|-0.72|||||The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.|Statistical analysis for data at Baseline compared to the data at Month 3||-0.72|-1.18|
71069186|NCT02989649|141647727|OTHER||Least Square Mean|-1.25|STANDARD_ERROR_OF_MEAN|0.098|||TWO_SIDED|95.0|-1.44|-1.05|||||The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.|Statistical analysis for data at Baseline compared to the data at Month 6||-1.05|-1.44|
71069187|NCT00281632|141647732|SUPERIORITY_OR_OTHER||Reponse rate|31.0||||||95.0|16.3|48.1|||||50% Response Rate (Normalized and Non-Normalized)|||48.1|16.3|
71069188|NCT00281632|141647736|SUPERIORITY_OR_OTHER||Response rate|17.6||||||95.0|3.8|43.4|||||Response rate (CR+PR)|||43.4|3.8|
71069189|NCT00281632|141647736|SUPERIORITY_OR_OTHER||Response rate|21.1||||||95.0|6.1|45.6|||||Response rate (CR+PR)|||45.6|6.1|
71069190|NCT00281632|141647736|SUPERIORITY_OR_OTHER||Response rate|19.4||||||95.0|8.2|36.0|||||Response rate (CR+PR)|||36.0|8.2|
71069191|NCT03382834|141647771|SUPERIORITY|||||||0.68|||||||t-test, 1 sided|The hypothesis was that tamoxifen would enhance the HIV transcription effect of vorinostat (i.e., log10 change would be greater in Arm A than Arm B)||||||0.68
71069192|NCT03382834|141647773|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||||||0.73
71079168|NCT03035916|141666060|OTHER|||||||0.112|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.112
71112980|NCT01659996|141733779|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% CI of the difference between the two proportions was \< δ for serogroup Y and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|2.46|||||TWO_SIDED|95.0|0.14|5.14||||||Meningococcal serogroup Y: The null hypothesis (H0: pm - ppm \> δ) was tested against the alternative hypothesis (H1: pm - ppm ≤ δ), where pm and ppm were the proportions of subjects in Group 1 and in Group 2, respectively, who achieved a Menactra vaccine response for meningococcal serogroups A, C, Y and W-135, with δ = 0.10.||5.14|0.14|
71112981|NCT01659996|141733779|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% CI of the difference between the two proportions was \< δ for serogroup W-135 and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|1.28|||||TWO_SIDED|95.0|-0.84|3.67||||||Meningococcal serogroup W-135: The null hypothesis (H0: pm - ppm \> δ) was tested against the alternative hypothesis (H1: pm - ppm ≤ δ), where pm and ppm were the proportions of subjects in Group 1 and in Group 2, respectively, who achieved a Menactra vaccine response for meningococcal serogroups A, C, Y and W-135, with δ = 0.10.||3.67|-0.84|
71112982|NCT01659996|141733784|NON_INFERIORITY_OR_EQUIVALENCE|Assuming that the antibodies concentration was log normally distributed, if the upper limit of the two-sided 95% CI of the ratio of the two GMCs is ≤ 1.5 for each antigen, the inferiority assumption was to be rejected.|Mean Difference (Final Values)|0.949|||||TWO_SIDED|95.0|0.852|1.06||||||Pertussis toxoid (PT): The null hypothesis (H0: GMCp / GMCpm \> 1.5) was tested against the alternative hypothesis (H1: GMCp / GMCpm ≤ 1.5), where GMCp and GMCpm were the GMCs of antibodies against the pertussis antigen (PT) in Group 3 and in Group 2, respectively||1.06|0.852|
71112983|NCT01659996|141733784|NON_INFERIORITY_OR_EQUIVALENCE|Assuming that the antibodies concentration was log normally distributed, if the upper limit of the two-sided 95% CI of the ratio of the two GMCs is ≤ 1.5 for each antigen, the inferiority assumption was to be rejected.|Mean Difference (Final Values)|0.968|||||TWO_SIDED|95.0|0.866|1.08||||||Filamentous hemagglutinin (FHA): The null hypothesis (H0: GMCp / GMCpm \> 1.5) was tested against the alternative hypothesis (H1: GMCp / GMCpm ≤ 1.5), where GMCp and GMCpm were the GMCs of antibodies against the pertussis antigen (FHA) in Group 3 and in Group 2, respectively||1.08|0.866|
71112984|NCT01659996|141733784|NON_INFERIORITY_OR_EQUIVALENCE|Assuming that the antibodies concentration was log normally distributed, if the upper limit of the two-sided 95% CI of the ratio of the two GMCs is ≤ 1.5 for each antigen, the inferiority assumption was to be rejected.|Mean Difference (Final Values)|1.11|||||TWO_SIDED|95.0|0.937|1.31||||||Pertactin (PRN): The null hypothesis (H0: GMCp / GMCpm \> 1.5) was tested against the alternative hypothesis (H1: GMCp / GMCpm ≤ 1.5), where GMCp and GMCpm were the GMCs of antibodies against the pertussis antigen (PRN) in Group 3 and in Group 2, respectively||1.31|0.937|
71112985|NCT01659996|141733785|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% CI of the difference between the two proportions was \< δ for each antibody and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|-1.22|||||TWO_SIDED|95.0|-5.44|3.19||||||Pertussis toxoid (PT) antigen: The null hypothesis (H0: pp - ppm \> δ) was tested against the alternative hypothesis (H1: pp - ppm ≤ δ), where pp and ppm were the proportions of subjects in Group 3 and Group 2, respectively, who achieved a pertussis vaccine response in antibodies against the pertussis antigen (PT), with δ = 0.10.||3.19|-5.44|
71117680|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-40.98|||<|0.001|TWO_SIDED|95.0|-59.41|-22.56||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-22.56|-59.41|<0.001
70852791|NCT02744040|141194416|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in total HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for Total HIV DNA.||||<0.0001
71117681|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-38.64|||<|0.001|TWO_SIDED|95.0|-57.49|-19.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-19.79|-57.49|<0.001
71117682|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-38.11|||<|0.001|TWO_SIDED|95.0|-56.94|-19.28||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-19.28|-56.94|<0.001
71117683|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-3.13||||0.274|TWO_SIDED|95.0|-8.67|2.4||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.40|-8.67|0.274
71117684|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-2.89||||0.304|TWO_SIDED|95.0|-8.4|2.62||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.62|-8.40|0.304
71069193|NCT00977314|141647799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_DEVIATION|1.0|<|0.001|||||||t-test, 2 sided|||The endpoint was the calculated difference between the HINT result for the unaided condition prior to the 30-day trial period (Day 1) and the HINT result using the SoundBite (aided) at the end of the 30-day trial period (Day 30).||||<0.001
71069194|NCT00288600|141647811|SUPERIORITY_OR_OTHER|||||||0.765|TWO_SIDED||||||Chi-squared, Corrected|||Need of Exchange transfusion following the AAP criteria||||0.765
71069195|NCT03600194|141647812|SUPERIORITY|||||||0.019|||||||Mixed Models Analysis|Design\*Therapy interaction term||||||.019
71069196|NCT01582178|141647817|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Fisher Exact|||||||0.89
71069197|NCT03852628|141647818|SUPERIORITY||Odds Ratio (OR)|0.17||||0.08|TWO_SIDED|95.0|0.02|1.22|||Mixed Models Analysis|Modeled the probability of having a reduction in AUD||The Placebo arm served as the reference group.||1.22|0.02|0.08
71069198|NCT03852628|141647819|SUPERIORITY||Odds Ratio (OR)|0.76||||0.69|TWO_SIDED|95.0|0.2|2.97|||Mixed Models Analysis|Modeled the probability of reduction in PTSD symptom.||The placebo arm served as the reference group.||2.97|0.20|0.690
71069199|NCT03852628|141647820|SUPERIORITY||Odds Ratio (OR)|0.63||||0.52|TWO_SIDED|95.0|0.15|2.66|||Mixed Models Analysis|Modeled the probability of have both a reduction in PTSD and AUD||The Placebo arm served as the reference group.||2.66|0.15|0.52
71069200|NCT00556933|141647827|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004|TWO_SIDED||||||Chi-squared|||||||0.0004
71069201|NCT00556933|141647828|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45|TWO_SIDED||||||General Linear Model|||||||0.45
71069202|NCT00556933|141647829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53|TWO_SIDED||||||Fisher Exact|||||||0.53
71069203|NCT00556933|141647830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.463|TWO_SIDED||||||Fisher Exact|||||||0.463
71069204|NCT00556933|141647831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.67|TWO_SIDED||||||Kaplan-Meier|||||||0.67
71069205|NCT00556933|141647832|SUPERIORITY_OR_OTHER_LEGACY|||||||0.193|TWO_SIDED||||||Fisher Exact|||||||0.193
71069206|NCT00556933|141647833|SUPERIORITY_OR_OTHER_LEGACY|||||||0.422|TWO_SIDED||||||Fisher Exact|||||||0.422
71069207|NCT00556933|141647834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.871|TWO_SIDED||||||Fisher Exact|||||||0.871
71069208|NCT00556933|141647835|SUPERIORITY_OR_OTHER_LEGACY|||||||0.068|TWO_SIDED||||||Kruskal-Wallis|||||||0.068
71069209|NCT00556933|141647836|SUPERIORITY_OR_OTHER_LEGACY|||||||0.67|TWO_SIDED||||||Fisher Exact|||||||0.67
71069210|NCT00556933|141647837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21|TWO_SIDED||||||Fisher Exact|||||||0.21
71069211|NCT00556933|141647838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|TWO_SIDED||||||Kruskal-Wallis|||||||0.40
71069212|NCT01106677|141647944|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation: assuming a difference between canagliflozin and placebo of 0.5% and a common standard deviation of 1.0%, and using a 2-sample, 1-sided t-test with a Type I error rate of 0.05, it was estimated that 86 subjects per group would provide 90% power to demonstrate superiority of canagliflozin over placebo.|Least-Squares Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|95.0|-0.758|-0.481|||ANCOVA|||||-0.481|-0.758|<0.001
71069213|NCT01106677|141647944|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation: assuming a difference between canagliflozin and placebo of 0.5% and a common standard deviation of 1.0%, and using a 2-sample, 1-sided t-test with a Type I error rate of 0.05, it was estimated that 86 subjects per group would provide 90% power to demonstrate superiority of canagliflozin over placebo.|Least-Squares Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|95.0|-0.914|-0.636|||ANCOVA|||||-0.636|-0.914|<0.001
71069214|NCT01106677|141647944|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.071|||TWO_SIDED|95.0|-0.795|-0.516||No formal statistical comparison was conducted.|ANCOVA|||||-0.516|-0.795|
71069215|NCT01106677|141647945|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.29|||<|0.001|TWO_SIDED|95.0|1.5|3.5|||Regression, Logistic|||||3.50|1.50|<0.001
71069216|NCT01106677|141647945|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.39|||<|0.001|TWO_SIDED|95.0|2.85|6.77|||Regression, Logistic|||||6.77|2.85|<0.001
71069217|NCT01106677|141647946|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-29.8|STANDARD_ERROR_OF_MEAN|3.044|<|0.001|TWO_SIDED|95.0|-35.76|-23.81|||ANCOVA|||||-23.81|-35.76|<0.001
71069218|NCT01106677|141647946|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-40.3|STANDARD_ERROR_OF_MEAN|3.055|<|0.001|TWO_SIDED|95.0|-46.25|-34.26|||ANCOVA|||||-34.26|-46.25|<0.001
71069219|NCT01106677|141647946|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-22.7|STANDARD_ERROR_OF_MEAN|3.06|||TWO_SIDED|95.0|-28.7|-16.69||No formal statistical comparison was conducted.|ANCOVA|||||-16.69|-28.70|
71069220|NCT01106677|141647947|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-38.1|STANDARD_ERROR_OF_MEAN|5.601|<|0.001|TWO_SIDED|95.0|-49.14|-27.16|||ANCOVA|||||-27.16|-49.14|<0.001
71069221|NCT01106677|141647947|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-47.3|STANDARD_ERROR_OF_MEAN|5.635|<|0.001|TWO_SIDED|95.0|-58.4|-36.29|||ANCOVA|||||-36.29|-58.40|<0.001
71069222|NCT01106677|141647947|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-39.6|STANDARD_ERROR_OF_MEAN|5.608|||TWO_SIDED|95.0|-50.56|-28.55||No formal statistical comparison was conducted.|ANCOVA|||||-28.55|-50.56|
71069223|NCT01106677|141647948|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.1|-1.9|||ANCOVA|||||-1.9|-3.1|<0.001
71069224|NCT01106677|141647948|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.5|-2.3|||ANCOVA|||||-2.3|-3.5|<0.001
71069225|NCT01106677|141647948|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.6|0.6||No formal statistical comparison was conducted.|ANCOVA|||||0.6|-0.6|
71069226|NCT01106677|141647949|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-5.36|STANDARD_ERROR_OF_MEAN|0.979|<|0.001|TWO_SIDED|95.0|-7.28|-3.439|||ANCOVA|||||-3.439|-7.280|<0.001
71069227|NCT01106677|141647949|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-6.58|STANDARD_ERROR_OF_MEAN|0.981|<|0.001|TWO_SIDED|95.0|-8.504|-4.653|||ANCOVA|||||-4.653|-8.504|<0.001
71069228|NCT01106677|141647949|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.34|STANDARD_ERROR_OF_MEAN|0.984|||TWO_SIDED|95.0|-5.273|-1.413||No formal statistical comparison was conducted.|ANCOVA|||||-1.413|-5.273|
71069229|NCT01106677|141647950|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|4.2||0.702||95.0|-9.9|6.7|||ANCOVA|||||6.7|-9.9|0.702
71069230|NCT01106677|141647950|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-4.7|STANDARD_ERROR_OF_MEAN|4.3||0.274|TWO_SIDED|95.0|-13.0|3.7|||ANCOVA|||||3.7|-13.0|0.274
71069231|NCT01106677|141647950|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-10.6|6.1||No formal statistical comparison was conducted.|ANCOVA|||||6.1|-10.6|
71069232|NCT01106677|141647951|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|3.6|9.7|||ANCOVA|||||9.7|3.6|<0.001
71069233|NCT01106677|141647951|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|8.5|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|5.4|11.5|||ANCOVA|||||11.5|5.4|<0.001
71069234|NCT01106677|141647951|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|1.6|||TWO_SIDED|95.0|-1.7|4.4||No formal statistical comparison was conducted.|ANCOVA|||||4.4|-1.7|
71069235|NCT01106677|141647952|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a discontinuation rate of 35% at Week 52, with a 2:2:2:1 treatment assignment ratio for canagliflozin 100 mg, canagliflozin 300 mg, sitagliptin 100 mg, or placebo, it was estimated that 360 subjects would need to be randomly assigned to each of the 3 active treatment groups and approximately 180 subjects to the placebo group to demonstrate non-inferiority with a non-inferiority margin of 0.3%.|Least-Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.061|||TWO_SIDED|95.0|-0.119|0.122|||ANCOVA|||||0.122|-0.119|
71069236|NCT01106677|141647952|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a discontinuation rate of 35% at Week 52, with a 2:2:2:1 treatment assignment ratio for canagliflozin 100 mg, canagliflozin 300 mg, sitagliptin 100 mg, or placebo, it was estimated that 360 subjects would need to be randomly assigned to each of the 3 active treatment groups and approximately 180 subjects to the placebo group to demonstrate non-inferiority with a non-inferiority margin of 0.3%.|Least-Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.062|||TWO_SIDED|95.0|-0.273|-0.031|||ANCOVA|||||-0.031|-0.273|
71069237|NCT01106677|141647953|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-8.55|STANDARD_ERROR_OF_MEAN|2.394|<|0.001|TWO_SIDED|95.0|-13.25|-3.857|||ANCOVA|||||-3.857|-13.25|<0.001
71069238|NCT01106677|141647953|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-17.5|STANDARD_ERROR_OF_MEAN|2.404|<|0.001|TWO_SIDED|95.0|-22.24|-12.81|||ANCOVA|||||-12.81|-22.24|<0.001
71069239|NCT01106677|141647954|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.0|-1.8|||ANCOVA|||||-1.8|-3.0|<0.001
71069240|NCT01106677|141647954|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.4|-2.3|||ANCOVA|||||-2.3|-3.4|<0.001
71069241|NCT01106677|141647955|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.87|STANDARD_ERROR_OF_MEAN|0.812|<|0.001|TWO_SIDED|95.0|-4.464|-1.276|||ANCOVA|||||-1.276|-4.464|<0.001
71069242|NCT01106677|141647955|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.99|STANDARD_ERROR_OF_MEAN|0.815|<|0.001|TWO_SIDED|95.0|-5.589|-2.389|||ANCOVA|||||-2.389|-5.589|<0.001
71069243|NCT01106677|141647956|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|2.3|STANDARD_ERROR_OF_MEAN|3.2||0.466|TWO_SIDED|95.0|-3.9|8.5|||ANCOVA|||||8.5|-3.9|0.466
71069244|NCT01106677|141647956|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|3.2||0.323|TWO_SIDED|95.0|-3.1|9.4|||ANCOVA|||||9.4|-3.1|0.323
71069245|NCT01106677|141647957|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|5.2|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|95.0|2.5|8.0|||ANCOVA|||||8.0|2.5|<0.001
71069246|NCT01106677|141647957|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|7.3|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|95.0|4.5|10.1|||ANCOVA|||||10.1|4.5|<0.001
71069247|NCT03681990|141647958|OTHER|Mixed Model ANOVA with subject as a random effect.||||||0.34||||||F test|ANOVA|||||||0.34
71069248|NCT03937908|141647960|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.01|||||||t-test, 2 sided|||Asiatic acid||||0.01
71069249|NCT03937908|141647960|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.23|||||||t-test, 2 sided|||Caffeic acid||||0.23
71112986|NCT01659996|141733785|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% CI of the difference between the two proportions was \< δ for each antibody and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|0.867|||||TWO_SIDED|95.0|-2.54|4.53||||||Filamentous hemagglutinin (FHA) antigen: The null hypothesis (H0: pp - ppm \> δ) was tested against the alternative hypothesis (H1: pp - ppm ≤ δ), where pp and ppm were the proportions of subjects in Group 3 and Group 2, respectively, who achieved a pertussis vaccine response in antibodies against the pertussis antigen (FHA), with δ = 0.10.||4.53|-2.54|
70852792|NCT02744040|141194416|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in total HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for Total HIV DNA.||||<0.0001
71112987|NCT01659996|141733785|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% CI of the difference between the two proportions was \< δ for each antibody and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|-0.092|||||TWO_SIDED|95.0|-3.62|3.66||||||Pertactin (PRN) antigen: The null hypothesis (H0: pp - ppm \> δ) was tested against the alternative hypothesis (H1: pp - ppm ≤ δ), where pp and ppm were the proportions of subjects in Group 3 and Group 2, respectively, who achieved a pertussis vaccine response in antibodies against the pertussis antigen (PRN), with δ = 0.10.||3.66|-3.62|
71112988|NCT00475085|141733800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.013||||0.718|TWO_SIDED|95.0|-0.225|0.2||Response skewed. P-value determined after Box-Cox transformation (lambda=-1.6). Significance level set to 0.017 to account for three tested hypotheses.|ANOVA|Testing and estimation performed using contrasts in the context of an omnibus ANOVA.||Group 1 - Group 2 (palonosetron vs. granisetron)||0.200|-0.225|0.718
71112989|NCT00475085|141733800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.195||||0.01|TWO_SIDED|95.0|-0.017|0.407||Response skewed. P-value determined after Box-Cox transformation (lambda=-1.6). Significance level set to 0.017 to account for three tested hypotheses.|ANOVA|Testing and estimation performed using contrasts in the context of an omnibus ANOVA.||Group 1 - Group 4 (adding dexamethasone)||0.407|-0.017|0.010
71112990|NCT00475085|141733800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025||||0.557|TWO_SIDED|95.0|-0.236|0.186||Response skewed. P-value determined after Box-Cox transformation (lambda=-1.6). Significance level set to 0.017 to account for three tested hypotheses.|ANOVA|Testing and estimation performed using contrasts in the context of an omnibus ANOVA.||Group 3 - Group 4 (aprepitant vs. prochlorperazine)||0.186|-0.236|0.557
71112991|NCT02574078|141733898|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.505|TWO_SIDED|95.0|0.24|2.03|||Unstratified log-rank|||||2.03|0.24|0.5050
71112992|NCT02574078|141733898|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.6284|TWO_SIDED|95.0|0.22|2.54|||Unstratified log-rank|||||2.54|0.22|0.6284
71112993|NCT02574078|141733898|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.1988|TWO_SIDED|95.0|0.4|1.22|||Unstratified log-rank|||||1.22|0.40|0.1988
71112994|NCT02574078|141733898|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.2722|TWO_SIDED|95.0|0.42|1.28|||Unstratified log-rank|||||1.28|0.42|0.2722
71112995|NCT02574078|141733898|SUPERIORITY||Hazard Ratio (HR)|0.42||||0.0544|TWO_SIDED|95.0|0.17|1.04|||Unstratified log-rank|||||1.04|0.17|0.0544
71112996|NCT02574078|141733898|SUPERIORITY||Hazard Ratio (HR)|2.04||||0.0442|TWO_SIDED|95.0|1.0|4.16|||Unstratified log-rank|||||4.16|1.00|0.0442
71112997|NCT02574078|141733898|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.5489|TWO_SIDED|95.0|0.5|1.45|||Log Rank|stratified by Disease Status (Recurrent Locally Advanced vs. Metastatic), Performance Status (ECOG 0 vs.1 vs. 2) as entered into the IVRS||||1.45|0.50|0.5489
71112998|NCT02574078|141733899|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9951|TWO_SIDED|95.0|0.35|2.91|||Unstratified log-rank|||||2.91|0.35|0.9951
71112999|NCT02574078|141733899|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.8321|TWO_SIDED|95.0|0.25|3.1|||Unstratified log-rank|||||3.10|0.25|0.8321
70852793|NCT02744040|141194416|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in total HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for Total HIV DNA.||||<0.0001
71113000|NCT02574078|141733899|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.2938|TWO_SIDED|95.0|0.41|1.31|||Unstratified log-rank|||||1.31|0.41|0.2938
71113001|NCT02574078|141733899|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.4819|TWO_SIDED|95.0|0.46|1.45|||Unstratified log-rank|||||1.45|0.46|0.4819
71113002|NCT02574078|141733899|SUPERIORITY||Hazard Ratio (HR)|0.31||||0.0241|TWO_SIDED|95.0|0.11|0.91|||Unstratified log-rank|||||0.91|0.11|0.0241
71113003|NCT02574078|141733899|SUPERIORITY||Hazard Ratio (HR)|1.59||||0.1401|TWO_SIDED|95.0|0.85|2.95|||Unstratified log-rank|||||2.95|0.85|0.1401
71113004|NCT02574078|141733903|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.2862|TWO_SIDED|95.0|0.4|1.31|||Log Rank|stratified by Disease Status (Recurrent Locally Advanced vs. Metastatic), Performance Status (ECOG 0 vs.1 vs. 2) as entered into the IVRS||||1.31|0.40|0.2862
71113005|NCT00301262|141733915|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.13|STANDARD_ERROR_OF_MEAN|3.405|<|0.0001||95.0|11.4|24.86||Since there was only one primary endpoint no multiple comparison adjustments were made for primary analysis. Final stat. model included centre, treatment, smoking status and history of ED as factors, and age, duration of ED (baseline) as covariates.|ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|The primary analysis population was the FAS. The sample size was estimated based on an expected difference of 16.5 with a standard deviation of 28.4, based on previously observed data.||24.86|11.40|<0.0001
71113006|NCT00301262|141733916|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.09|STANDARD_DEVIATION|14.761||0.0028||95.0|1.8|8.37|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||8.370|1.800|0.0028
71113007|NCT00301262|141733916|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|26.02|STANDARD_DEVIATION|22.294|<|0.0001||95.0|20.58|31.455|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||31.455|20.580|<0.0001
71113008|NCT00301262|141733917|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.76|STANDARD_ERROR_OF_MEAN|0.656||0.008||95.0|0.47|3.06|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||3.06|0.47|0.0080
71113009|NCT00301262|141733918|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.94|STANDARD_DEVIATION|2.909||0.0051||95.0|0.29|1.585|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||1.585|0.290|0.0051
71113010|NCT00301262|141733918|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.79|STANDARD_DEVIATION|4.013|<|0.0001||95.0|1.812|3.77|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||3.770|1.812|<0.0001
71113011|NCT00301262|141733919|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.61|STANDARD_ERROR_OF_MEAN|0.922||0.0054||95.0|0.78|4.43|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||4.43|0.78|0.0054
71113012|NCT00301262|141733920|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.368||0.4232||95.0|-0.43|1.02|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||1.02|-0.43|0.4232
71113013|NCT00301262|141733921|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|0.277||0.0156||95.0|0.13|1.22|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||1.22|0.13|0.0156
71113014|NCT00301262|141733922|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|0.458||0.0096||95.0|0.3|2.11|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||2.11|0.30|0.0096
71113015|NCT00301262|141733923|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.359||0.0135||95.0|0.19|1.61|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||1.61|0.19|0.0135
71113016|NCT00301262|141733924|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.49|STANDARD_DEVIATION|4.392||0.0033||95.0|0.051|2.465|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||2.465|0.0510|0.0033
71113017|NCT00301262|141733924|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.22|STANDARD_DEVIATION|6.346|<|0.0001||95.0|3.676|6.772|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||6.772|3.676|<0.0001
71113018|NCT00301262|141733925|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.57||0.2581||95.0|-0.149|0.549|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||0.549|-0.149|0.2581
71113019|NCT00301262|141733925|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.39|STANDARD_DEVIATION|2.582|<|0.0001||95.0|0.758|2.018|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||2.018|0.758|<0.0001
71113020|NCT00301262|141733926|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.18|STANDARD_DEVIATION|1.456||0.2857||95.0|-0.149|0.499|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||0.499|-0.149|0.2857
71113021|NCT00301262|141733926|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.76|STANDARD_DEVIATION|1.706||0.0005||95.0|0.345|1.177|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||1.177|0.345|0.0005
71113022|NCT00301262|141733927|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.75|STANDARD_DEVIATION|2.548||0.0102||95.0|0.183|1.317|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||1.317|0.183|0.0102
71113023|NCT00301262|141733927|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.28|STANDARD_DEVIATION|2.979|<|0.0001||95.0|1.557|3.01|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||3.010|1.557|<0.0001
71113024|NCT00301262|141733928|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.68|STANDARD_DEVIATION|1.847||0.0016||95.0|0.264|1.086|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||1.086|0.264|0.0016
71113025|NCT00301262|141733928|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.9|STANDARD_DEVIATION|2.297|<|0.0001||95.0|1.335|2.456|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||2.456|1.335|<0.0001
71113026|NCT00301262|141733929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.78|STANDARD_ERROR_OF_MEAN|1.038||0.0083||95.0|0.73|4.83|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||4.83|0.73|0.0083
71113027|NCT00301262|141733930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.06|STANDARD_DEVIATION|5.193||0.9146||95.0|-1.218|1.093|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||1.093|-1.218|0.9146
71113028|NCT00301262|141733930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.54|STANDARD_DEVIATION|6.463|<|0.0001||95.0|3.961|7.114|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||7.114|3.961|<0.0001
71113029|NCT00301262|141733931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.42|STANDARD_ERROR_OF_MEAN|4.826||0.0002||95.0|8.88|27.96|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||27.96|8.88|0.0002
71113030|NCT00301262|141733932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.41|STANDARD_DEVIATION|20.444||0.0064||95.0|1.857|10.956|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||10.956|1.857|0.0064
71113031|NCT00301262|141733932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|26.8|STANDARD_DEVIATION|29.384|<|0.0001|TWO_SIDED|95.0|19.636|33.971|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||33.971|19.636|<0.0001
71113032|NCT00301262|141733933|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.491||||0.0001||95.0|3.042|13.851|||Regression, Logistic|||||13.851|3.042|0.0001
71113033|NCT00301262|141733934|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.915|||<|0.0001||95.0|2.396|10.08|||Regression, Logistic|||||10.080|2.396|<0.0001
71113034|NCT00301262|141733935|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.676||||0.0187||95.0|1.242|10.875|||Regression, Logistic|||||10.875|1.242|0.0187
71113035|NCT00301262|141733936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.9|STANDARD_ERROR_OF_MEAN|4.716||0.0037||95.0|4.59|23.22|||independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||23.22|4.59|0.0037
71113036|NCT00301262|141733937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.72|STANDARD_ERROR_OF_MEAN|4.496||0.0321||95.0|0.84|18.6|||independent-samples t-test||Mean Difference = Week 8 - Baseline|||18.60|0.84|0.0321
71113037|NCT00301262|141733938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.97|STANDARD_ERROR_OF_MEAN|3.901||0.0427||95.0|-15.68|-0.27|||independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||-0.27|-15.68|0.0427
71113038|NCT00301262|141733939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.6|STANDARD_ERROR_OF_MEAN|3.903||0.0533||95.0|-15.32|0.11|||independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||0.11|-15.32|0.0533
71113039|NCT00301262|141733940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.167|STANDARD_ERROR_OF_MEAN|0.3041||0.0002||95.0|0.566|1.768|||2-sample independent t-test||A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).|||1.768|0.566|0.0002
71113040|NCT00301262|141733941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.4454|STANDARD_ERROR_OF_MEAN|0.3638||0.0001||95.0|0.727|2.164|||2-sample independent t-test||A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).|||2.164|0.727|0.0001
71113041|NCT00301262|141733942|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.1821|STANDARD_ERROR_OF_MEAN|0.3946||0.0032||95.0|0.403|1.961|||2-sample independent t-test||A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).|||1.961|0.403|0.0032
71113042|NCT00301262|141733943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.2123|STANDARD_ERROR_OF_MEAN|0.3549||0.0008||95.0|0.511|1.913|||2-sample independent t-test||A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).|||1.913|0.511|0.0008
71113043|NCT00301262|141733944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.39|STANDARD_DEVIATION|1.454||0.0195||95.0|0.064|0.711|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||0.711|0.064|0.0195
71113044|NCT00301262|141733944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.09|STANDARD_DEVIATION|2.207|<|0.0001||95.0|1.551|2.628|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||2.628|1.551|<0.0001
71113045|NCT00301262|141733945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.4|STANDARD_DEVIATION|1.489||0.0186||95.0|0.069|0.731|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||0.731|0.069|0.0186
71113046|NCT00301262|141733945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.67|STANDARD_DEVIATION|2.573|<|0.0001||95.0|2.044|3.299|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||3.299|2.044|<0.0001
71113047|NCT00301262|141733946|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.65|STANDARD_DEVIATION|1.917||0.0033||95.0|0.223|1.077|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||1.077|0.223|0.0033
71113048|NCT00301262|141733946|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.61|STANDARD_DEVIATION|2.335|<|0.0001||95.0|2.042|3.182|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||3.182|2.042|<0.0001
71113049|NCT00301262|141733947|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.45|STANDARD_DEVIATION|1.606||0.0143||95.0|0.093|0.807|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||0.807|0.093|0.0143
71113050|NCT00301262|141733947|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.99|STANDARD_DEVIATION|2.178|<|0.0001||95.0|1.454|2.516|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||2.516|1.454|<0.0001
71113051|NCT00301262|141733948|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0325||95.0|||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.||||0.0325
71113052|NCT00301262|141733948|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.||||<0.0001
71113053|NCT00301262|141733949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0196||95.0|||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.||||0.0196
71113054|NCT00301262|141733949|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.||||<0.0001
71113055|NCT00301262|141733950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173||95.0|||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.||||0.3173
71113056|NCT00301262|141733950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0016||95.0|||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.||||0.0016
71113057|NCT00301262|141733951|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-5.55|STANDARD_ERROR_OF_MEAN|2.958||0.0624||95.0|-11.39|0.29|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||0.29|-11.39|0.0624
71113058|NCT00301262|141733951|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.38|STANDARD_ERROR_OF_MEAN|1.835||0.4523||95.0|-2.24|5.01|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||5.01|-2.24|0.4523
71113059|NCT00301262|141733952|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.48|STANDARD_ERROR_OF_MEAN|1.962||0.2081||95.0|-6.35|1.4|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||1.40|-6.35|0.2081
70852794|NCT02744040|141194416|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in total HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for Total HIV DNA.||||<0.0001
71113060|NCT00301262|141733952|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.61|STANDARD_ERROR_OF_MEAN|1.958||0.4131||95.0|-2.26|5.48|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||5.48|-2.26|0.4131
71113061|NCT00301262|141733953|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.77|STANDARD_ERROR_OF_MEAN|2.126||0.4069||95.0|-5.97|2.43|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||2.43|-5.97|0.4069
71113062|NCT00301262|141733953|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.37|STANDARD_ERROR_OF_MEAN|1.489||0.1137||95.0|-0.57|5.31|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||5.31|-0.57|0.1137
71113063|NCT00301262|141733954|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-12.23|STANDARD_ERROR_OF_MEAN|4.829||0.0123||95.0|-21.77|-2.7|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||-2.70|-21.77|0.0123
71113064|NCT00301262|141733954|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.62|STANDARD_ERROR_OF_MEAN|4.883||0.8993||95.0|-10.27|9.03|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||9.03|-10.27|0.8993
71113065|NCT00301262|141733955|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|22.03|STANDARD_ERROR_OF_MEAN|5.458|<|0.0001||95.0|11.25|32.81|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||32.81|11.25|<0.0001
71113066|NCT00301262|141733955|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.74|STANDARD_ERROR_OF_MEAN|5.818||0.4165||95.0|-16.24|6.76|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||6.76|-16.24|0.4165
71113067|NCT00301262|141733956|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.8|STANDARD_ERROR_OF_MEAN|4.351||0.0257||95.0|1.21|18.39|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||18.39|1.21|0.0257
71113068|NCT00301262|141733956|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-5.36|STANDARD_ERROR_OF_MEAN|3.209||0.0971||95.0|-11.7|0.98|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||0.98|-11.70|0.0971
71113069|NCT00301262|141733957|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-3.18|STANDARD_ERROR_OF_MEAN|1.754||0.0726||95.0|-6.66|0.3|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||0.30|-6.66|0.0726
71113070|NCT00301262|141733957|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.04|STANDARD_ERROR_OF_MEAN|1.798||0.2581||95.0|-5.61|1.52|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||1.52|-5.61|0.2581
70852795|NCT02744040|141194417|OTHER||||||>|0.05||||||Multiple hypothesis testing was performed using Tukey's HSD procedure.|Mixed Effects Models|||Integrated HIV DNA at the time of ART initiation in each of the three EDDI groups||||>0.05
71069250|NCT03937908|141647960|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.001||||||Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.|t-test, 2 sided|||Dihydrocaffeic acid||||0.001
71069251|NCT03937908|141647960|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.05|||||||t-test, 2 sided|||Dihydroferulic acid||||0.05
71069252|NCT03937908|141647960|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.07|||||||t-test, 2 sided|||Ferulic acid||||0.07
71069253|NCT03937908|141647960|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.09|||||||t-test, 2 sided|||3-(3-hydroxyphenyl)propionic acid||||0.09
71069254|NCT03937908|141647960|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.003|||||||t-test, 2 sided|||Isoferulic acid||||0.003
71069255|NCT03937908|141647960|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.1|||||||t-test, 2 sided|||Madecassic acid||||0.10
71069256|NCT03937908|141647960|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.11|||||||t-test, 2 sided|||Monocaffeoylquinic acids||||0.11
71069257|NCT03937908|141647961|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.82|||||||t-test, 2 sided|||Asiatic acid||||0.82
71069258|NCT03937908|141647961|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.4|||||||t-test, 2 sided|||Caffeic acid||||0.40
71069259|NCT03937908|141647961|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.2|||||||t-test, 2 sided|||Dihydrocaffeic acid||||0.20
71069260|NCT03937908|141647961|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.48|||||||t-test, 2 sided|||Dihydroferulic acid||||0.48
71069261|NCT03937908|141647961|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.2|||||||t-test, 2 sided|||Ferulic acid||||0.20
71069262|NCT03937908|141647961|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.32|||||||t-test, 2 sided|||3-(3-hydroxyphenyl)propionic acid||||0.32
71069263|NCT03937908|141647961|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.35|||||||t-test, 2 sided|||Isoferulic acid||||0.35
71069264|NCT03937908|141647961|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.52|||||||t-test, 2 sided|||Madecassic acid||||0.52
71069265|NCT03937908|141647961|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.13|||||||t-test, 2 sided|||Monocaffeoylquinic acids||||0.13
71113071|NCT00301262|141733958|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.04|STANDARD_ERROR_OF_MEAN|4.45||0.8158||95.0|-9.86|7.78|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||7.78|-9.86|0.8158
71113072|NCT00301262|141733958|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|1.692||0.8464||95.0|-3.68|3.02|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||3.02|-3.68|0.8464
71113073|NCT00301262|141733959|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|5.789||0.9529||95.0|-11.82|11.13|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||11.13|-11.82|0.9529
71069266|NCT03937908|141647962|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.34|||||||t-test, 2 sided|||Asiatic acid||||0.34
71069267|NCT03937908|141647962|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.08|||||||t-test, 2 sided|||Dihydrocaffeic acid||||0.08
71069268|NCT03937908|141647962|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.23|||||||t-test, 2 sided|||Dihydroferulic acid||||0.23
71113074|NCT00301262|141733959|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.69|STANDARD_ERROR_OF_MEAN|4.994||0.8899||95.0|-10.59|9.2|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||9.20|-10.59|0.8899
71113075|NCT00301262|141733960|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-10.18|STANDARD_ERROR_OF_MEAN|7.897||0.2001||95.0|-25.83|5.47|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||5.47|-25.83|0.2001
71113076|NCT00301262|141733960|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.68|STANDARD_ERROR_OF_MEAN|6.724||0.1527||95.0|-3.64|23.01|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||23.01|-3.64|0.1527
71113077|NCT00301262|141733961|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.74|STANDARD_ERROR_OF_MEAN|7.774||0.0606||95.0|-0.67|30.15|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||30.15|-0.67|0.0606
71113078|NCT00301262|141733961|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.62|STANDARD_ERROR_OF_MEAN|7.318||0.3678||95.0|-21.12|7.88|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||7.88|-21.12|0.3678
71113079|NCT00301262|141733962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.56|STANDARD_ERROR_OF_MEAN|7.474||0.5429||95.0|-10.25|19.37|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||19.37|-10.25|0.5429
71113080|NCT00301262|141733962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.07|STANDARD_ERROR_OF_MEAN|5.595||0.5849||95.0|-8.02|14.15|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||14.15|-8.02|0.5849
71113081|NCT00301262|141733963|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|18.86|STANDARD_ERROR_OF_MEAN|4.952||0.0002||95.0|9.08|28.64|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||28.64|9.08|0.0002
71113082|NCT00301262|141733963|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.93|STANDARD_ERROR_OF_MEAN|6.212||0.429||95.0|-7.35|17.2|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||17.20|-7.35|0.4290
71113083|NCT00368745|141733964|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2838||95.0||||significance determined using 2-tailed significance level of 0.05|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with country as a covariate||Primary objective: evaluate the efficacy of pregabalin in maintaining the benzodiazepine free state in subjects with prior stable alprazolam use.||||0.2838
71113084|NCT00368745|141733965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.48|STANDARD_ERROR_OF_MEAN|0.81||0.0709||95.0|-3.1|0.13||contrasts performed using Dunnett's Test|ANCOVA|Least squares (LS) Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Alprazolam Taper (AT) Week 1||0.13|-3.10|0.0709
71113085|NCT00368745|141733965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.89|STANDARD_ERROR_OF_MEAN|1.08||0.0006||95.0|-6.04|-1.74||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 2||-1.74|-6.04|0.0006
71113086|NCT00368745|141733965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.38|STANDARD_ERROR_OF_MEAN|1.3||0.0718||95.0|-4.98|0.22||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 3||0.22|-4.98|0.0718
71113087|NCT00368745|141733965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.38|STANDARD_ERROR_OF_MEAN|1.92||0.092||95.0|-7.37|0.6||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 4||0.60|-7.37|0.0920
71113088|NCT00368745|141733965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.22|STANDARD_ERROR_OF_MEAN|3.04||0.1371||95.0|-12.67|2.23||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT week 5||2.23|-12.67|0.1371
71113089|NCT00368745|141733965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.68|STANDARD_ERROR_OF_MEAN|2.04||0.0882||95.0|-7.96|0.61||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 6||0.61|-7.96|0.0882
71113090|NCT00368745|141733965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.83|STANDARD_ERROR_OF_MEAN|1.11||0.0135||95.0|-5.05|-0.61||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Alprazolam Free (AF) Week 1||-0.61|-5.05|0.0135
71113091|NCT00368745|141733965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|1.18||0.3924||95.0|-3.38|1.35||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 2||1.35|-3.38|0.3924
71113092|NCT00368745|141733965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|1.14||0.3868||95.0|-3.29|1.3||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 3||1.30|-3.29|0.3868
71069269|NCT03937908|141647962|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.14|||||||t-test, 2 sided|||Ferulic acid||||0.14
71069270|NCT03937908|141647962|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.28|||||||t-test, 2 sided|||3-(3-hydroxyphenyl)propionic acid||||0.28
71069271|NCT03937908|141647962|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.17|||||||t-test, 2 sided|||Isoferulic acid||||0.17
71069272|NCT03937908|141647962|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.98|||||||t-test, 2 sided|||Madecassic acid||||0.98
71069273|NCT03937908|141647962|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.16|||||||t-test, 2 sided|||Monocaffeoylquinic acids||||0.16
71069274|NCT03937908|141647963|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.04|||||||t-test, 2 sided|||Asiatic acid||||0.04
71069275|NCT03937908|141647963|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.01|||||||t-test, 2 sided|||Caffeic acid||||0.01
71069276|NCT03937908|141647963|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.06|||||||t-test, 2 sided|||Dihydrocaffeic acid||||0.06
71069277|NCT03937908|141647963|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.08|||||||t-test, 2 sided|||Dihydroferulic acid||||0.08
71069278|NCT03937908|141647963|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.56|||||||t-test, 2 sided|||Dicaffeoylquinic acids||||0.56
71069279|NCT03937908|141647963|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.21|||||||t-test, 2 sided|||Ferulic acid||||0.21
71069280|NCT03937908|141647963|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.05|||||||t-test, 2 sided|||3-(3-hydroxyphenyl)propionic acid||||0.05
71069281|NCT03937908|141647963|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.05|||||||t-test, 2 sided|||Isoferulic acid||||0.05
71069282|NCT03937908|141647963|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.23|||||||t-test, 2 sided|||Madecassic acid||||0.23
71069283|NCT03937908|141647963|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.16|||||||t-test, 2 sided|||Monocaffeoylquinic acids||||0.16
71069284|NCT03937908|141647964|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.7|||||||t-test, 2 sided|||Asiatic acid||||0.7
71069285|NCT03937908|141647964|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.09|||||||t-test, 2 sided|||Madecassic acid||||0.09
71069286|NCT03937908|141647964|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.4|||||||t-test, 2 sided|||Asiaticoside||||0.4
71069287|NCT03937908|141647964|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.6|||||||t-test, 2 sided|||Madecassoside||||0.6
71069288|NCT03937908|141647964|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.4|||||||t-test, 2 sided|||Monocaffeoylquinic acids||||0.4
71069289|NCT03937908|141647964|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.1|||||||t-test, 2 sided|||Dicaffeoylquinic acids||||0.1
71069290|NCT03937908|141647964|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.9|||||||t-test, 2 sided|||3-(3-hydroxyphenyl)propionic acid||||0.9
71069291|NCT03937908|141647964|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.03|||||||t-test, 2 sided|||Caffeic acid||||0.03
71069292|NCT03937908|141647964|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.9|||||||t-test, 2 sided|||Ferulic acid||||0.9
71069293|NCT03937908|141647964|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.6|||||||t-test, 2 sided|||Isoferulic acid||||0.6
71069294|NCT03937908|141647964|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.4|||||||t-test, 2 sided|||Dihydroferulic acid||||0.4
71069295|NCT03937908|141647964|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.8|||||||t-test, 2 sided|||Dihydrocaffeic acid||||0.8
71069296|NCT03937908|141647965|EQUIVALENCE|Two-sided paired t-tests were used to compare fold induction between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.1|||||||t-test, 1 sided|||1 hour||||0.1
71069297|NCT03937908|141647965|EQUIVALENCE|Two-sided paired t-tests were used to compare fold induction between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.1|||||||t-test, 1 sided|||2 hours||||0.1
71069298|NCT03937908|141647965|EQUIVALENCE|Two-sided paired t-tests were used to compare fold induction between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.3|||||||t-test, 1 sided|||3 hours||||0.3
71069299|NCT03937908|141647965|EQUIVALENCE|Two-sided paired t-tests were used to compare fold induction between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.5|||||||t-test, 1 sided|||4 hours||||0.5
71069300|NCT03937908|141647965|EQUIVALENCE|Two-sided paired t-tests were used to compare fold induction between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.5|||||||t-test, 1 sided|||6 hours||||0.5
71069301|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|3.998|||||TWO_SIDED|95.0|2.659|6.009||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||6.009|2.659|
71069302|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.222|||||TWO_SIDED|95.0|0.813|1.838||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.838|0.813|
71069303|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.661|||||TWO_SIDED|95.0|0.44|0.994||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.994|0.440|
71069304|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|2.178|||||TWO_SIDED|95.0|1.449|3.276||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.276|1.449|
71069305|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.017|||||TWO_SIDED|95.0|0.676|1.528||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.528|0.676|
71069306|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.673|||||TWO_SIDED|95.0|0.448|1.012||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.012|0.448|
71069307|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.742|||||TWO_SIDED|95.0|1.156|2.626||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.626|1.156|
71079169|NCT03035916|141666061|OTHER|||||||0.645|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.645
71079170|NCT03035916|141666061|OTHER|||||||0.645|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.645
71079171|NCT03035916|141666061|OTHER|||||||0.314|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.314
71079172|NCT03035916|141666061|OTHER|||||||0.003|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."||||0.003
71079173|NCT03035916|141666061|OTHER|||||||0.367|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."||||0.367
71079174|NCT03035916|141666061|OTHER|||||||0.031|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."||||0.031
71079175|NCT03035916|141666061|OTHER|||||||0.009|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."||||0.009
71079176|NCT03035916|141666061|OTHER|||||||0.873|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."||||0.873
71079177|NCT03035916|141666061|OTHER|||||||0.026|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."||||0.026
71079178|NCT03035916|141666061|OTHER|||||||0.411|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."||||0.411
71079179|NCT03035916|141666061|OTHER|||||||0.787|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."||||0.787
71079180|NCT03035916|141666061|OTHER|||||||0.306|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."||||0.306
71079181|NCT03035916|141666061|OTHER|||||||0.921|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."||||0.921
71079182|NCT03035916|141666061|OTHER|||||||0.001|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."||||0.001
71079183|NCT03035916|141666061|OTHER|||||||0.001|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."||||0.001
71079184|NCT03035916|141666061|OTHER|||||||0.555|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."||||0.555
71079185|NCT03035916|141666061|OTHER|||||||0.058|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."||||0.058
71079186|NCT03035916|141666061|OTHER|||||||0.166|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."||||0.166
71079187|NCT03035916|141666061|OTHER|||||||0.288|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.288
71079188|NCT03035916|141666061|OTHER|||||||0.299|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.299
71079189|NCT03035916|141666061|OTHER|||||||0.051|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.051
71079190|NCT03035916|141666061|OTHER|||||||0.186|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.186
71079191|NCT03035916|141666061|OTHER|||||||0.555|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.555
71079192|NCT03035916|141666061|OTHER|||||||0.065|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.065
71079193|NCT03035916|141666061|OTHER|||||||0.168|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.168
71069308|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.306|||||TWO_SIDED|95.0|0.204|0.458||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.458|0.204|
71069309|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.165|||||TWO_SIDED|95.0|0.11|0.248||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.248|0.110|
71069310|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.545|||||TWO_SIDED|95.0|0.363|0.818||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.818|0.363|
71069311|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.254|||||TWO_SIDED|95.0|0.17|0.381||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.381|0.170|
71079194|NCT03035916|141666061|OTHER|||||||0.739|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.739
71079195|NCT03035916|141666061|OTHER|||||||0.079|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.079
71079196|NCT03035916|141666062|OTHER|||||||0.056|||||||t-test, 2 sided|||||||0.056
71079197|NCT03035916|141666062|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
71079198|NCT03035916|141666062|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
71079199|NCT03035916|141666063|OTHER|||||||0.056||||||p\<0.05 indicates that the data difference is statistically significant.|t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 1 hour after surgery row."||||0.056
71079200|NCT03035916|141666063|OTHER|||||||0.009||||||p\<0.05 indicates that the data difference is statistically significant.|t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 1 hour after surgery row."||||0.009
71079201|NCT03035916|141666063|OTHER|||||||0.001||||||p\<0.05 indicates that the data difference is statistically significant.|t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 1 hour after surgery row."||||0.001
71079202|NCT03035916|141666063|OTHER|||||||0.198|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."||||0.198
71079203|NCT03035916|141666063|OTHER|||||||0.047|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."||||0.047
71028494|NCT02129348|141564533|SUPERIORITY||Treatment Effect Difference|1.79||||0.25|TWO_SIDED|95.0|0.64|5.04||The threshold of statistical significance was p = 0.05.|Chi-squared|||CGI behavior change scores were categorized into responders versus non-responders (1 or 2 versus ≥3) using the last variable observation for drop-outs. A x² test was used to identify the percentage of participants in each group, lithium versus placebo, that improved from baseline to week 12.||5.04|0.64|0.25
71028495|NCT02129348|141564534|SUPERIORITY||Treatment Effect Difference|2.0||||0.21|TWO_SIDED|95.0|-1.1|5.1||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||5.1|-1.1|0.21
71028496|NCT02129348|141564535|SUPERIORITY||Treatment Effect Difference|-0.1||||0.91|TWO_SIDED|95.0|-2.6|2.4||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||2.4|-2.6|0.91
71028497|NCT02129348|141564536|SUPERIORITY||Treatment Effect Difference|0.1||||0.94|TWO_SIDED|95.0|-1.5|1.4||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Effect size (d)= -0.02 (Cohen's D)|In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||1.4|-1.5|0.94
71028498|NCT02129348|141564537|SUPERIORITY||Treatment Effect Difference|0.2||||0.63|TWO_SIDED|95.0|-0.4|0.8||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||0.8|-0.4|0.63
71028499|NCT02129348|141564538|SUPERIORITY||Treatment Effect Difference|3.2||||0.24|TWO_SIDED|95.0|-2.1|8.4||The threshold of statistical significance was p = 0.05.|Mixed Models Analysis||Effect size (d)= 0.44 (Cohen's D)|In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||8.4|-2.1|0.24
71028500|NCT02129348|141564539|SUPERIORITY||Treatment Effect Difference|0.0||||0.96|TWO_SIDED|95.0|-1.7|1.8||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Cohen's d=0.01|In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||1.8|-1.7|0.96
71028501|NCT02129348|141564540|SUPERIORITY||Treatment Effect Difference|2.2||||0.35|TWO_SIDED|95.0|-2.3|6.6||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Cohen's d=0.35|In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||6.6|-2.3|0.35
71028502|NCT00796822|141564604|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.87|STANDARD_DEVIATION|1.09||0.44|TWO_SIDED|95.0|-1.53|3.28|||t-test, 2 sided|||The sample size was determined based on a two-sample, independent, two-tailed t-test with 5% type I error. Using the results from our pilot trial, we conservatively estimated a predicted absolute change in FMD of 3.5% with PTX (assuming no change with placebo) and we assumed a common standard deviation of 2.6%. A sample size of 10 per group was estimated to provide at least 80% power to detect this effect size. Allowing for a 20% dropout rate, we planned to recruit 13 subjects per group.||3.28|-1.53|0.44
71028503|NCT00796822|141564605|SUPERIORITY|There was no formal power calculation for this outcome measure as the study was powered on the primary outcome measure.|Median Difference (Net)|149.1|STANDARD_DEVIATION|151.8||0.03|TWO_SIDED|95.0|16.4|281.9|||t-test, 2 sided|||||281.9|16.4|0.03
71028504|NCT04646109|141564629|SUPERIORITY|||||||0.43||||||A p\<0.05 value was considered statistically significant|Chi-squared|||||||0.43
71028505|NCT04646109|141564630|SUPERIORITY|||||||0.14||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.14
71028506|NCT04646109|141564631|SUPERIORITY|||||||0.68||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.68
71028507|NCT04646109|141564632|SUPERIORITY|||||||0.15||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.15
71028508|NCT04646109|141564633|SUPERIORITY|||||||0.37||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.37
71028509|NCT04646109|141564634|SUPERIORITY|||||||0.12||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.12
71028510|NCT04646109|141564635|SUPERIORITY|||||||0.22||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.22
71069312|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.168|||||TWO_SIDED|95.0|0.112|0.252||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.252|0.112|
71113093|NCT00368745|141733965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|1.15||0.9966||95.0|-2.31|2.32||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 4||2.32|-2.31|0.9966
71113094|NCT00368745|141733965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|1.26||0.6873||95.0|-3.07|2.05||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 5||2.05|-3.07|0.6873
71113095|NCT00368745|141733965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|1.35||0.5337||95.0|-3.62|1.91||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 6||1.91|-3.62|0.5337
71113096|NCT00368745|141733965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.79|STANDARD_ERROR_OF_MEAN|1.37||0.0008||95.0|-7.51|-2.07||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Endpoint \[LOCF\]||-2.07|-7.51|0.0008
71113097|NCT00368745|141733968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.18|STANDARD_ERROR_OF_MEAN|1.4||0.122||95.0|-4.97|0.6||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Taper (AT) Week 1||0.60|-4.97|0.1220
71113098|NCT00368745|141733968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.63|STANDARD_ERROR_OF_MEAN|1.26||0.0053||95.0|-6.15|-1.11||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 2||-1.11|-6.15|0.0053
71113099|NCT00368745|141733968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.85|STANDARD_ERROR_OF_MEAN|1.73||0.1048||95.0|-6.32|0.62||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 3||0.62|-6.32|0.1048
71069313|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.436|||||TWO_SIDED|95.0|0.29|0.655||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.655|0.290|
71069314|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.541|||||TWO_SIDED|95.0|0.361|0.811||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.811|0.361|
71069315|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.783|||||TWO_SIDED|95.0|1.188|2.676||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.676|1.188|
71069316|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.832|||||TWO_SIDED|95.0|0.555|1.246||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.246|0.555|
71113100|NCT00368745|141733968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.41|STANDARD_ERROR_OF_MEAN|1.52||0.0357||95.0|-6.57|-0.25||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 4||-0.25|-6.57|0.0357
71113101|NCT00368745|141733968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.28|STANDARD_ERROR_OF_MEAN|2.67||0.4263||95.0|-8.82|4.26||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 5||4.26|-8.82|0.4263
71113102|NCT00368745|141733968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.73|STANDARD_ERROR_OF_MEAN|2.02||0.0104||95.0|-9.96|-1.51||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 6||-1.51|-9.96|0.0104
71113103|NCT00368745|141733968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.92|STANDARD_ERROR_OF_MEAN|1.4||0.0069||95.0|-6.73|-1.12||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Free (AF) Week 1||-1.12|-6.73|0.0069
71113104|NCT00368745|141733968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.71|STANDARD_ERROR_OF_MEAN|1.37||0.2185||95.0|-4.47|1.05||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 2||1.05|-4.47|0.2185
71113105|NCT00368745|141733968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|1.06||0.7832||95.0|-2.41|1.83||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 3||1.83|-2.41|0.7832
71028511|NCT04646109|141564638|SUPERIORITY|||||||0.1||||||A p\<0.05 value was considered statistically significant|Chi-squared|||||||0.10
71028512|NCT04646109|141564639|SUPERIORITY|||||||0.37||||||A p\<0.05 value was considered statistically significant|Chi-squared|||||||0.37
71028513|NCT04646109|141564640|SUPERIORITY|||||||0.03||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.03
71028514|NCT04646109|141564641|SUPERIORITY|||||||0.39||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.39
71028515|NCT04646109|141564642|SUPERIORITY|||||||0.24||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.24
71028516|NCT04646109|141564643|SUPERIORITY|||||||0.56||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.56
71028517|NCT04646109|141564644|SUPERIORITY|||||||0.005||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.005
71028518|NCT04646109|141564645|SUPERIORITY|||||||0.03||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.03
71028519|NCT04646109|141564646|SUPERIORITY|||||||0.01||||||A p\<0.05 value was considered statistically significant|Chi-squared|||||||0.01
71028520|NCT04634409|141564700|SUPERIORITY||Odds Ratio (OR)|0.37||||0.009273|TWO_SIDED|95.0|0.18|0.78|||Regression, Logistic|||||0.78|0.18|0.009273
71028521|NCT04634409|141564700|SUPERIORITY||Odds Ratio (OR)|0.32||||0.000271|TWO_SIDED|95.0|0.18|0.59|||Regression, Logistic|||||0.59|0.18|0.000271
71028522|NCT04634409|141564700|SUPERIORITY||Odds Ratio (OR)|0.23||||0.000257|TWO_SIDED|95.0|0.1|0.51|||Regression, Logistic|||||0.51|0.10|0.000257
71028523|NCT04634409|141564700|SUPERIORITY||Odds Ratio (OR)|0.44||||0.013378|TWO_SIDED|95.0|0.23|0.84|||Regression, Logistic|||||0.84|0.23|0.013378
71028524|NCT04634409|141564700|SUPERIORITY||Odds Ratio (OR)|0.24||||0.000318|TWO_SIDED|95.0|0.11|0.52|||Regression, Logistic|||||0.52|0.11|0.000318
71028525|NCT04634409|141564700|SUPERIORITY||Odds Ratio (OR)|0.35||||0.140563|TWO_SIDED|95.0|0.09|1.41|||Regression, Logistic|||||1.41|0.09|0.140563
71028526|NCT04634409|141564701|SUPERIORITY||Odds Ratio (OR)|0.27||||0.000835|TWO_SIDED|95.0|0.12|0.58|||Regression, Logistic|||||0.58|0.12|0.000835
71028527|NCT04634409|141564702|SUPERIORITY||Odds Ratio (OR)|0.56||||0.097231|TWO_SIDED|95.0|0.28|1.11|||Regression, Logistic|||||1.11|0.28|0.097231
71028528|NCT04634409|141564702|SUPERIORITY||Odds Ratio (OR)|0.59||||0.13236|TWO_SIDED|95.0|0.3|1.17|||Regression, Logistic|||||1.17|0.30|0.132360
71028529|NCT04634409|141564708|SUPERIORITY||Odds Ratio (OR)|0.62||||0.769|TWO_SIDED|95.0|0.02|15.57|||Regression, Logistic|||||15.57|0.02|0.769
71028530|NCT04634409|141564708|SUPERIORITY||Odds Ratio (OR)|0.32||||0.494|TWO_SIDED|95.0|0.01|8.12|||Regression, Logistic|||||8.12|0.01|0.494
71028531|NCT04634409|141564708|SUPERIORITY||Odds Ratio (OR)|0.5||||0.671|TWO_SIDED|95.0|0.02|12.51|||Regression, Logistic|||||12.51|0.02|0.671
71028532|NCT04634409|141564708|SUPERIORITY||Odds Ratio (OR)|0.49||||0.663|TWO_SIDED|95.0|0.02|12.27|||Regression, Logistic|||||12.27|0.02|0.663
71028533|NCT04634409|141564708|SUPERIORITY||Odds Ratio (OR)|0.51||||0.68|TWO_SIDED|95.0|0.02|12.76|||Regression, Logistic|||||12.76|0.02|0.680
71028534|NCT04634409|141564708|SUPERIORITY||Odds Ratio (OR)|2.51||||0.584|TWO_SIDED|95.0|0.09|67.88|||Regression, Logistic|||||67.88|0.09|0.584
71028535|NCT04634409|141564710|SUPERIORITY||Odds Ratio (OR)|1.02||||0.979|TWO_SIDED|95.0|0.17|6.06|||Regression, Logistic|||||6.06|0.17|0.979
71028536|NCT04634409|141564710|SUPERIORITY||Odds Ratio (OR)|1.42||||0.675|TWO_SIDED|95.0|0.27|7.39|||Regression, Logistic|||||7.39|0.27|0.675
71028537|NCT04634409|141564713|SUPERIORITY||LSM Difference|-0.67||||0.009|TWO_SIDED|95.0|-1.17|-0.17|||Mixed Models Analysis|||||-0.17|-1.17|0.009
71028538|NCT04634409|141564713|SUPERIORITY||LSM Difference|-0.65||||0.002|TWO_SIDED|95.0|-1.06|-0.24|||Mixed Models Analysis|||||-0.24|-1.06|0.002
71028539|NCT04634409|141564713|SUPERIORITY||LSM Difference|-0.26||||0.263|TWO_SIDED|95.0|-0.72|0.2|||Mixed Models Analysis|||||0.20|-0.72|0.263
71028540|NCT04634409|141564713|SUPERIORITY||LSM Difference|-0.41||||0.083|TWO_SIDED|95.0|-0.87|0.05|||Mixed Models Analysis|||||0.05|-0.87|0.083
71028541|NCT04634409|141564713|SUPERIORITY||LSM Difference|-0.87|||<|0.001|TWO_SIDED|95.0|-1.35|-0.4|||Mixed Models Analysis|||||-0.40|-1.35|<0.001
71028542|NCT04634409|141564713|SUPERIORITY||LSM Difference|-0.64||||0.149|TWO_SIDED|95.0|-1.52|0.23|||Mixed Models Analysis|||||0.23|-1.52|0.149
71028543|NCT04634409|141564714|SUPERIORITY||LSM Difference|-0.82||||0.002|TWO_SIDED|95.0|-1.33|-0.31|||Mixed Models Analysis|||||-0.31|-1.33|0.002
71028544|NCT04634409|141564715|SUPERIORITY||LSM Difference|-0.14||||0.606|TWO_SIDED|95.0|-0.7|0.41|||Mixed Models Analysis|||||0.41|-0.70|0.606
71028545|NCT04634409|141564715|SUPERIORITY||LSM Difference|-0.38||||0.17|TWO_SIDED|95.0|-0.93|0.17|||Mixed Models Analysis|||||0.17|-0.93|0.170
71028546|NCT04634409|141564721|SUPERIORITY||Odds Ratio (OR)|0.96||||0.89|TWO_SIDED|95.0|0.53|1.73|||Regression, Logistic|||||1.73|0.53|0.890
71028547|NCT04634409|141564721|SUPERIORITY||Odds Ratio (OR)|1.43||||0.141|TWO_SIDED|95.0|0.89|2.29|||Regression, Logistic|||||2.29|0.89|0.141
71028548|NCT04634409|141564721|SUPERIORITY||Odds Ratio (OR)|1.15||||0.603|TWO_SIDED|95.0|0.67|1.98|||Regression, Logistic|||||1.98|0.67|0.603
71028549|NCT04634409|141564721|SUPERIORITY||Odds Ratio (OR)|1.69||||0.048|TWO_SIDED|95.0|1.0|2.84|||Regression, Logistic|||||2.84|1.00|0.048
71028550|NCT04634409|141564721|SUPERIORITY||Odds Ratio (OR)|1.19||||0.533|TWO_SIDED|95.0|0.69|2.04|||Regression, Logistic|||||2.04|0.69|0.533
71028551|NCT04634409|141564721|SUPERIORITY||Odds Ratio (OR)|1.09||||0.869|TWO_SIDED|95.0|0.4|2.99|||Regression, Logistic|||||2.99|0.40|0.869
71028552|NCT04634409|141564722|SUPERIORITY||Odds Ratio (OR)|1.31||||0.374|TWO_SIDED|95.0|0.72|2.35|||Regression, Logistic|||||2.35|0.72|0.374
71028553|NCT04634409|141564723|SUPERIORITY||Odds Ratio (OR)|1.87||||0.015|TWO_SIDED|95.0|1.13|3.08|||Regression, Logistic|||||3.08|1.13|0.015
71028554|NCT04634409|141564723|SUPERIORITY||Odds Ratio (OR)|1.29||||0.317|TWO_SIDED|95.0|0.78|2.11|||Regression, Logistic|||||2.11|0.78|0.317
71028555|NCT04634409|141564726|SUPERIORITY||Odds Ratio (OR)|1.62||||0.082|TWO_SIDED|95.0|0.94|2.81|||Regression, Logistic|||||2.81|0.94|0.082
71028556|NCT04634409|141564726|SUPERIORITY||Odds Ratio (OR)|1.86||||0.018|TWO_SIDED|95.0|1.11|3.11|||Regression, Logistic|||||3.11|1.11|0.018
71028557|NCT04634409|141564726|SUPERIORITY||Odds Ratio (OR)|1.71||||0.021|TWO_SIDED|95.0|1.09|2.71|||Regression, Logistic|||||2.71|1.09|0.021
71028558|NCT04634409|141564726|SUPERIORITY||Odds Ratio (OR)|1.93||||0.011|TWO_SIDED|95.0|1.16|3.22|||Regression, Logistic|||||3.22|1.16|0.011
71028559|NCT04634409|141564726|SUPERIORITY||Odds Ratio (OR)|2.17||||0.003|TWO_SIDED|95.0|1.3|3.6|||Regression, Logistic|||||3.60|1.30|0.003
71028560|NCT04634409|141564726|SUPERIORITY||Odds Ratio (OR)|1.34||||0.546|TWO_SIDED|95.0|0.52|3.48|||Regression, Logistic|||||3.48|0.52|0.546
71028561|NCT04634409|141564727|SUPERIORITY||Odds Ratio (OR)|1.04||||0.888|TWO_SIDED|95.0|0.6|1.82|||Regression, Logistic|||||1.82|0.60|0.888
71028562|NCT04634409|141564728|SUPERIORITY||Odds Ratio (OR)|1.88||||0.014|TWO_SIDED|95.0|1.13|3.13|||Regression, Logistic|||||3.13|1.13|0.014
71028563|NCT04634409|141564728|SUPERIORITY||Odds Ratio (OR)|1.63||||0.057|TWO_SIDED|95.0|0.98|2.71|||Regression, Logistic|||||2.71|0.98|0.057
71028564|NCT01739790|141564744|OTHER|||||||0.45|||||||Fisher Exact|||||||0.45
71028565|NCT02581345|141564745|EQUIVALENCE|Per Food and Drug Administration (FDA), the equivalence testing was made using 90% confidence interval and an equivalence margin of 18%|Difference in proportion (M923 - EU RPP)|0.014|||||TWO_SIDED|90.0|-0.043|0.072||||||||0.072|-0.043|
71028566|NCT02581345|141564745|EQUIVALENCE|Per European Medicines Agency (EMA), the equivalence testing was made using 95% confidence interval and an equivalence margin of 15%|Difference in proportion (M923 - EU RPP)|0.014|||||TWO_SIDED|95.0|-0.054|0.082||||||||0.082|-0.054|
71028567|NCT02581345|141564746|OTHER|No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale was calculated using stratified Newcombe method.|Difference in proportion (M923 - EU RPP)|0.031|||||TWO_SIDED|95.0|-0.048|0.11||||||||0.110|-0.048|
71028568|NCT02581345|141564747|OTHER|No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale calculated using stratified Newcombe method. Protocol defined margins are: \[-0.18;+0.18\] for 90% confidence interval.|Difference in proportion (M923 - EU RPP)|-0.022|||||TWO_SIDED|90.0|-0.061|0.016||||||||0.016|-0.061|
71028569|NCT02581345|141564747|OTHER|No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale calculated using stratified Newcombe method. Protocol defined margins are: \[-0.15;+0.15\] for 95% confidence interval.|Difference in proportion (M923 - EU RPP)|-0.022|||||TWO_SIDED|95.0|-0.069|0.024||||||||0.024|-0.069|
71028570|NCT02581345|141564750|OTHER|No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale calculated using stratified Newcombe method. Protocol defined margins are: \[-0.18;+0.18\] for 90% confidence interval.|Difference in proportion (M923 - EU RPP)|0.08|||||TWO_SIDED|90.0|0.01|0.149||||||||0.149|0.010|
71028571|NCT02581345|141564750|OTHER|No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale calculated using stratified Newcombe method. Protocol defined margins are:\[-0.15;+0.15\] for 95% confidence interval.|Difference in proportion (M923 - EU RPP)|0.08|||||TWO_SIDED|95.0|-0.004|0.162||||||||0.162|-0.004|
71028572|NCT02122796|141564782|SUPERIORITY_OR_OTHER||||||<|0.01||||||Means of pre- and post-treatment measurements were compared using paired, two-sided Student's t tests. P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student's t tests.|t-test, 2 sided|P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student's t tests.||||||<0.01
71028573|NCT02122796|141564783|SUPERIORITY_OR_OTHER||||||<|0.01||||||Means of pre- and post-treatment measurements were compared using paired, two-sided Student's t tests. P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student's t tests.|t-test, 2 sided|P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student's t tests.||||||<0.01
71028574|NCT02122796|141564785|SUPERIORITY_OR_OTHER||||||<|0.01||||||Means of pre- and post-treatment measurements were compared using paired, two-sided Student's t tests. P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student's t tests.|t-test, 2 sided|P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student's t tests.||||||<0.01
71028575|NCT01244126|141564794|SUPERIORITY_OR_OTHER||Kruskall Wallis ANOVA by ranks|0.21|STANDARD_DEVIATION|3.0||0.21|TWO_SIDED|95.0|||||Kruskal-Wallis|||The primary outcome of the study was the maximum postoperative FLACC pain score.||||0.21
71028576|NCT01244126|141564795|SUPERIORITY_OR_OTHER||Kruskall Wallis ANOVA|0.34||||0.34||95.0|||||Kruskal-Wallis|||Kruskall Wallis test||||0.34
71028577|NCT00863746|141564799|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9934||||0.4687|TWO_SIDED|95.0|0.8409|1.1735||p-value of one-sided test (significance level 2.5%)|Log Rank|stratified by region, number of prior treatments, presence brain mets at baseline, prior EGFR inhibitor treatment||Test for superiority of Sorafenib over Placebo||1.1735|0.8409|0.4687
71028578|NCT00863746|141564800|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6068|||<|0.0001|TWO_SIDED|95.0|0.5139|0.7165||p-value of one-sided test (significance level 2.5%)|Log Rank|stratified by region, number of prior treatments, presence brain mets at baseline, prior EGFR inhibitor treatment||Test for superiority of Sorafenib over Placebo||0.7165|0.5139|<0.0001
71028579|NCT00863746|141564801|SUPERIORITY_OR_OTHER||CMH-adjusted difference in proportions|0.2263|||<|1e-06|TWO_SIDED|95.0|0.1575|0.2952|||Cochran-Mantel-Haenszel|stratified by region, number of prior treatments, presence brain mets at baseline, prior EGFR inhibitor treatment||||0.2952|0.1575|<0.000001
71028580|NCT00863746|141564802|SUPERIORITY_OR_OTHER||CMH-adjusted difference in proportions|0.039||||0.000876|TWO_SIDED|95.0|0.0137|0.0642|||Cochran-Mantel-Haenszel|stratified by region, number of prior treatments, presence brain mets at baseline, prior EGFR inhibitor treatment||||0.0642|0.0137|0.000876
71079204|NCT03035916|141666063|OTHER|||||||0.002|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."||||0.002
71079205|NCT03035916|141666063|OTHER|||||||0.102|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."||||0.102
71079206|NCT03035916|141666063|OTHER|||||||0.005|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."||||0.005
71079207|NCT03035916|141666063|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."||||0.001
71079208|NCT03035916|141666063|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."||||0.001
71079209|NCT03035916|141666063|OTHER|||||||0.023|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."||||0.023
71079210|NCT03035916|141666063|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."||||0.001
71079211|NCT03035916|141666063|OTHER|||||||0.425|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."||||0.425
71079212|NCT03035916|141666063|OTHER|||||||0.124|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."||||0.124
71079213|NCT03035916|141666063|OTHER|||||||0.052|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."||||0.052
71079214|NCT03035916|141666064|OTHER|||||||0.176||||||p\<0.05 indicates that the data difference is statistically significant.|t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 1 hour after surgery row."||||0.176
71079215|NCT03035916|141666064|OTHER|||||||0.001||||||p\<0.05 indicates that the data difference is statistically significant.|t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 1 hour after surgery row."||||0.001
71079216|NCT03035916|141666064|OTHER|||||||0.228|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."||||0.228
71079217|NCT03035916|141666064|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."||||0.001
71079218|NCT03035916|141666064|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."||||0.001
71079219|NCT03035916|141666064|OTHER|||||||0.057|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."||||0.057
71079220|NCT03035916|141666064|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."||||0.001
71079221|NCT03035916|141666064|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."||||0.001
71079222|NCT03035916|141666064|OTHER|||||||0.004|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."||||0.004
71079223|NCT03035916|141666064|OTHER|||||||0.005|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."||||0.005
71079224|NCT03035916|141666064|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."||||0.001
71113106|NCT00368745|141733968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|1.16||0.7062||95.0|-1.9|2.79||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 4||2.79|-1.90|0.7062
71113107|NCT00368745|141733968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|1.04||0.7161||95.0|-2.49|1.73||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 5||1.73|-2.49|0.7161
71113108|NCT00368745|141733968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.11|STANDARD_ERROR_OF_MEAN|1.43||0.0376||95.0|-6.03|-0.19||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 6||-0.19|-6.03|0.0376
71113109|NCT00368745|141733968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|1.48||0.0122||95.0|-6.74|-0.85||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Endpoint \[LOCF\]||-0.85|-6.74|0.0122
71113110|NCT00368745|141733970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.16||0.0052||95.0|-0.76|-0.14||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Alprazolam Taper (AT) Week 1||-0.14|-0.76|0.0052
71113111|NCT00368745|141733970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.18||0.0001||95.0|-1.11|-0.38||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 2||-0.38|-1.11|0.0001
71113112|NCT00368745|141733970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.25||0.0528||95.0|-1.0|0.01||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 3||0.01|-1.00|0.0528
71113113|NCT00368745|141733970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.35||0.3085||95.0|-1.11|0.37||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 4||0.37|-1.11|0.3085
71113114|NCT00368745|141733970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.47||0.1807||95.0|-1.92|0.47||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 5||0.47|-1.92|0.1807
71113115|NCT00368745|141733970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.42||0.1074||95.0|-1.58|0.17||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 6||0.17|-1.58|0.1074
71113116|NCT00368745|141733970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.2||0.0013||95.0|-1.1|-0.28||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Alprazolam Free (AF) Week 1||-0.28|-1.10|0.0013
71113117|NCT00368745|141733970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.25||0.0503||95.0|-0.99|0.0||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 2||0.00|-0.99|0.0503
71028581|NCT00863746|141564803|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.542|||<|0.0001|TWO_SIDED|95.0|0.4526|0.6492||p-value of one-sided test (significance level 2.5%)|Log Rank|stratified by region, number of prior treatments, presence brain mets at baseline, prior EGFR inhibitor treatment||Test for superiority of Sorafenib over Placebo||0.6492|0.4526|<0.0001
71113118|NCT00368745|141733970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.26||0.0364||95.0|-1.09|-0.04||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 3||-0.04|-1.09|0.0364
71113119|NCT00368745|141733970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.24||0.914||95.0|-0.51|0.46||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 4||0.46|-0.51|0.9140
71113120|NCT00368745|141733970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.27||0.7789||95.0|-0.62|0.47||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 5||0.47|-0.62|0.7789
71113121|NCT00368745|141733970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.31||0.3189||95.0|-0.95|0.32||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 6||0.32|-0.95|0.3189
71113122|NCT00368745|141733970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|0.25||0.0031||95.0|-1.26|-0.27||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Endpoint \[LOCF\]||-0.27|-1.26|0.0031
71113123|NCT00368745|141733971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.24||0.126||95.0|-0.86|0.11||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Taper (AT) Week 1||0.11|-0.86|0.1260
71079225|NCT03035916|141666064|OTHER|||||||0.002|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."||||0.002
71079226|NCT03035916|141666064|OTHER|||||||0.002|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."||||0.002
71028582|NCT00863746|141564804|SUPERIORITY_OR_OTHER|||||||0.3121||||||p-value for test of treatment effect equal to 0.|Mixed Models Analysis|||||||0.3121
71028583|NCT00863746|141564805|SUPERIORITY_OR_OTHER|||||||0.2948||||||p-value for test of treatment effect equal to 0|Mixed Models Analysis|||||||0.2948
71028584|NCT00863746|141564806|SUPERIORITY_OR_OTHER|||||||0.8344||||||p-value for test of treatment effect equal to 0|Mixed Models Analysis|||||||0.8344
71028585|NCT00863746|141564807|SUPERIORITY_OR_OTHER|||||||0.1438||||||p-value for test of treatment effect equal to 0.|Mixed Models Analysis|||||||0.1438
71028586|NCT00863746|141564808|SUPERIORITY_OR_OTHER|||||||0.9228||||||p-value for treatment effect equal to 0.|Mixed Models Analysis|||||||0.9228
71028587|NCT00862979|141564812|SUPERIORITY||Mean Difference (Net)|-11.3|||<|0.0001|TWO_SIDED|95.0|-16.5|-6.1|||ANCOVA|||||-6.1|-16.5|<.0001
71028588|NCT00862979|141564813|OTHER|difference||||||0.203|||||||Fisher Exact|||Month 6 to Month 9||||0.203
71028589|NCT00862979|141564813|OTHER|difference||||||0.002|||||||Fisher Exact|||Month 9 to Month 18||||0.002
71028590|NCT00862979|141564815|SUPERIORITY||Mean Difference (Final Values)|-14.0|||<|0.0001|TWO_SIDED|95.0|-19.6|-8.3|||ANCOVA|||Month 12||-8.3|-19.6|<.0001
71028591|NCT00862979|141564815|SUPERIORITY||Mean Difference (Final Values)|-11.3|||<|0.0001|TWO_SIDED|95.0|-16.5|-6.1|||ANCOVA|||Month 18||-6.1|-16.5|<.0001
71028592|NCT00862979|141564817|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
71028593|NCT00502775|141564829|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|0.16|<|0.001||95.0|-1.2|-0.6||Symptom scores were grouped in 3 families: nasal, ocular, instantaneous. Within each family, results of hypothesis tests were adjusted using Hochberg's method.|ANCOVA|No other strata or covariates, other than investigator, were defined.|Mean Difference = Mean Change in Fluticasone Furoate - Mean Change in Fexofenadine|The primary efficacy measure, mean change from baseline over the two-week treatment period in NSS compared between fluticasone furoate and fexofenadine, was assessed at a significance level of α=0.05. If the null hypothesis of this comparison was rejected, then the secondary measures were subject to hypothesis testing. The study was powered at 90%.||-0.6|-1.2|<0.001
71028594|NCT00502775|141564829|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|0.16|<|0.001||95.0|-1.1|-0.4|||ANCOVA||Mean Difference = Mean Change in Fluticasone Furoate - Mean Change in Placebo|||-0.4|-1.1|<0.001
71028595|NCT00502775|141564829|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.16||0.374||95.0|-0.2|0.5|||ANCOVA||Mean Difference = Mean Change in Fexofenadine - Mean Change in Placebo|||0.5|-0.2|0.374
71028596|NCT00262600|141564849|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.|Cox Proportional Hazard|0.9|||<|0.0001||95.0|0.74|1.1||p-value for protocol specified margin of 1.46|Regression, Cox|||Non-inferiority comparison of dabigatran 110 mg to warfarin||1.10|0.74|<.0001
71028597|NCT00262600|141564849|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.|Cox Proportional Hazard|0.65|||<|0.0001||95.0|0.52|0.81||p-value for protocol specified margin of 1.46|Regression, Cox|||Non-inferiority comparison of dabigatran 150 mg to warfarin||0.81|0.52|<.0001
71028598|NCT00262600|141564850|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.93||||0.2206||95.0|0.83|1.04||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.||||1.04|0.83|0.2206
71028599|NCT00262600|141564850|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83||||0.0015||95.0|0.74|0.93||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.||||0.93|0.74|0.0015
71028600|NCT00262600|141564851|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.98||||0.7508||95.0|0.87|1.11||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.||||1.11|0.87|0.7508
71028601|NCT00262600|141564851|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.84||||0.0093||95.0|0.74|0.96||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.||||0.96|0.74|0.0093
71028602|NCT00262600|141564852|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8||||0.0026||95.0|0.7|0.93||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using Cox regression analysis with treatment in the model.||Analysis is for adjudicated major bleeds||0.93|0.70|0.0026
71028603|NCT00262600|141564852|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.93||||0.3146||95.0|0.81|1.07||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using Cox regression analysis with treatment in the model.||Analysis is for adjudicated major bleeds||1.07|0.81|0.3146
71028604|NCT00262600|141564853|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.3|||<|0.0001||95.0|0.19|0.45||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using Cox regression analysis with treatment in the model.||Analysis of ICH||0.45|0.19|<0.0001
71028605|NCT00262600|141564853|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.41|||<|0.0001||95.0|0.28|0.6||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using Cox regression analysis with treatment in the model.||Analysis of ICH||0.60|0.28|<0.0001
71028606|NCT02906709|141564858|SUPERIORITY||Difference in the Least Squares Means|-0.9|||<|0.001|TWO_SIDED|95.0|-1.15|-0.66|||Constrained Longitudinal Data Analysis||||Based on a Constrained Longitudinal Data Analysis model with terms for treatment, prior AHA therapy status (yes/no), time and the interaction of time by treatment, time by prior anti-hyperglycemic agent (AHA) therapy status and time by treatment by prior AHA status with the restriction of a common baseline mean between two treatment groups.|-0.66|-1.15|<0.001
71028607|NCT02906709|141564859|SUPERIORITY||Difference in % vs. Placebo|7.0|||||TWO_SIDED|95.0|-8.4|21.8|||||||Based on Miettinen \& Nurminen method.|21.8|-8.4|
71028608|NCT02906709|141564861|SUPERIORITY||Difference in % vs. Placebo|-4.1|||||TWO_SIDED|95.0|-12.8|0.4|||||||Based on Miettinen \& Nurminen method.|0.4|-12.8|
71079227|NCT03035916|141666064|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."||||0.001
71079228|NCT03035916|141666065|OTHER|||||||0.585|||||||t-test, 2 sided|||||||0.585
71079229|NCT03035916|141666065|OTHER|||||||0.071|||||||t-test, 2 sided|||||||0.071
71079230|NCT03035916|141666065|OTHER|||||||0.13|||||||t-test, 2 sided|||||||0.13
71079231|NCT03035916|141666066|OTHER|||||||0.644|||||||t-test, 2 sided|||||||0.644
71079232|NCT03035916|141666066|OTHER|||||||0.045|||||||t-test, 2 sided|||||||0.045
71079233|NCT03035916|141666066|OTHER|||||||0.031|||||||t-test, 2 sided|||||||0.031
71079234|NCT03035916|141666067|OTHER|||||||0.421|||||||t-test, 2 sided|||||||0.421
71079235|NCT03035916|141666067|OTHER|||||||0.046|||||||t-test, 2 sided|||||||0.046
71079236|NCT03035916|141666067|OTHER|||||||0.007|||||||t-test, 2 sided|||||||0.007
71079237|NCT03035916|141666068|OTHER|||||||0.91|||||||t-test, 2 sided|||||||0.910
71079238|NCT03035916|141666068|OTHER|||||||0.864|||||||t-test, 2 sided|||||||0.864
71079239|NCT03035916|141666068|OTHER|||||||0.785|||||||t-test, 2 sided|||||||0.785
71079240|NCT03035916|141666069|OTHER|||||||0.972|||||||t-test, 2 sided|||||||0.972
71079241|NCT03035916|141666069|OTHER|||||||0.987|||||||t-test, 2 sided|||||||0.987
71079242|NCT03035916|141666069|OTHER|||||||0.518|||||||t-test, 2 sided|||||||0.518
71079243|NCT02442206|141666107|SUPERIORITY||Mean Difference (Net)|10.27|||<|0.0001|TWO_SIDED|95.0|6.209|14.331|||ANOVA|||||14.331|6.209|<0.0001
71079244|NCT02442206|141666108|SUPERIORITY||Mean Difference (Net)|0.42|||<|0.0001|TWO_SIDED|95.0|0.36|0.49|||ANOVA|||||0.49|0.36|<0.0001
71079245|NCT02442206|141666109|SUPERIORITY||Mean Difference (Net)|0.67|||<|0.0001|TWO_SIDED|95.0|0.55|0.8|||ANOVA|||||0.80|0.55|<0.0001
71079246|NCT02442206|141666110|SUPERIORITY||Mean Difference (Net)|0.446|||<|0.0001|TWO_SIDED|95.0|0.352|0.541|||ANOVA|||||0.541|0.352|<0.0001
71079247|NCT02442206|141666111|SUPERIORITY||Mean Difference (Net)|-0.177||||0.0017|TWO_SIDED|95.0|-0.285|-0.07|||ANOVA|||||-0.070|-0.285|0.0017
71079248|NCT02442206|141666112|SUPERIORITY||Mean Difference (Net)|-0.751|||<|0.0001|TWO_SIDED|95.0|-0.925|-0.577|||ANOVA|||||-0.577|-0.925|<0.0001
71079249|NCT02442206|141666113|SUPERIORITY||Mean Difference (Net)|-1.639|||<|0.0001|TWO_SIDED|95.0|-1.945|-1.332|||ANOVA|||||-1.332|-1.945|<0.0001
71079250|NCT02442206|141666114|SUPERIORITY||Mean Difference (Net)|-0.625|||<|0.0001|TWO_SIDED|95.0|-0.761|-0.489|||ANOVA|||||-0.489|-0.761|<0.0001
71079251|NCT02442206|141666115|SUPERIORITY||Mean Difference (Net)|1.209||||0.142|TWO_SIDED|95.0|-0.419|2.836|||ANOVA|||LV EF||2.836|-0.419|0.1420
71113124|NCT00368745|141733971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.29||0.0074||95.0|-1.4|-0.22||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 2||-0.22|-1.40|0.0074
71113125|NCT00368745|141733971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.38||0.125||95.0|-1.35|0.17||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 3||0.17|-1.35|0.1250
71113126|NCT00368745|141733971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.6||0.8991||95.0|-1.17|1.32||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 4||1.32|-1.17|0.8991
71113127|NCT00368745|141733971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.53||0.1747||95.0|-2.07|0.46||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 5||0.46|-2.07|0.1747
71113128|NCT00368745|141733971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.45||0.0744||95.0|-1.79|0.09||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 6||0.09|-1.79|0.0744
70852796|NCT02744040|141194418|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in integrated HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for integrated HIV DNA.||||<0.0001
70852797|NCT02744040|141194418|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in integrated HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for integrated HIV DNA.||||<0.0001
71113129|NCT00368745|141733971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.35||0.0063||95.0|-1.67|-0.29||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Free (AF) Week 1||-0.29|-1.67|0.0063
71113130|NCT00368745|141733971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.34||0.014||95.0|-1.56|-0.18||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 2||-0.18|-1.56|0.0140
71113131|NCT00368745|141733971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.34||0.0267||95.0|-1.46|-0.09||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 3||-0.09|-1.46|0.0267
71069317|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.551|||||TWO_SIDED|95.0|0.367|0.826||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.826|0.367|
71069318|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.426|||||TWO_SIDED|95.0|0.95|2.14||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.140|0.950|
71069319|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|3.295|||||TWO_SIDED|95.0|2.196|4.944||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||4.944|2.196|
71069320|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.538|||||TWO_SIDED|95.0|1.026|2.303||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.303|1.026|
71069321|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.018|||||TWO_SIDED|95.0|0.679|1.526||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.526|0.679|
71079252|NCT02442206|141666115|SUPERIORITY||Mean Difference (Net)|1.131||||0.1732|TWO_SIDED|95.0|-0.512|2.774|||ANOVA|||RV EF||2.774|-0.512|0.1732
71079253|NCT02442206|141666116|SUPERIORITY||Mean Difference (Net)|2.241||||0.0437|TWO_SIDED|95.0|0.066|4.417|||ANOVA|||LV ESV||4.417|0.066|0.0437
71079254|NCT02442206|141666116|SUPERIORITY||Mean Difference (Net)|2.095||||0.1236|TWO_SIDED|95.0|-0.591|4.782|||ANOVA|||RV ESV||4.782|-0.591|0.1236
71079255|NCT02442206|141666117|SUPERIORITY||Mean Difference (Net)|9.357||||0.0002|TWO_SIDED|95.0|4.649|14.065|||ANOVA|||||14.065|4.649|0.0002
71079256|NCT02442206|141666118|SUPERIORITY||Mean Difference (Net)|0.337||||0.0032|TWO_SIDED|95.0|0.118|0.555|||ANOVA|||LVCO||0.555|0.118|0.0032
71079257|NCT02442206|141666118|SUPERIORITY||Mean Difference (Net)|0.281||||0.0182|TWO_SIDED|95.0|0.05|0.512|||ANOVA|||RVCO||0.512|0.050|0.0182
71079258|NCT00497146|141666119|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||Mixed Models Analysis|Mixed model includes treatment, visit, gender, baseline RAAS inhibitor use, country, baseline value, and treatment by visit interaction.||||||0.145
71079259|NCT00929994|141666141|OTHER||||||=|0.06||||||A Bonferroni correction for multiple testing was used for post hoc contrasts. Assumption of sphericity was met for all analyses determined by the Mauchley test of sphericity (all \>.05).|ANOVA|||With 1 group and 3 test times, a repeated measures analysis of variance of 6MWD, was utilized between the 3 test times 0, 3, and 6 months). A Bonferroni correction for multiple testing was used for post hoc contrasts.||||=0.06
71079260|NCT00929994|141666141|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
71079261|NCT00929994|141666142|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
71079262|NCT00929994|141666143|SUPERIORITY|||||||0.04||||||A Bonferroni correction for multiple testing was used for post-hoc contrasts.|ANOVA|||With 1 group and 3 test times, a repeated measures analysis of variance with pairwise comparisons of CES-D was utilized between the 3 test times baseline, 3 and 6 months.||||0.04
71079263|NCT00929994|141666144|SUPERIORITY||||||>|0.05||||||A Bonferroni correction for multiple testing was used for post-hoc contrasts|ANOVA|||With 1 group and 3 test times, a repeated measures analysis of variance with pairwise comparisons of MoCA was utilized between the 3 test times (-3, 0 and 6 months). A Bonferroni correction for multiple testing was used for post-hoc contrasts.||||>0.05
71079264|NCT01964989|141666159|SUPERIORITY|Relative vaccine efficacy (rVE; ≥6 to \<72 months) rVE = (1-HR) is the relative vaccine efficacy of aQIV and HR is defined as hazard ratio between aQIV and non adjuvanted comparator.|Cox Proportional Hazard|-0.67|||||TWO_SIDED|95.0|-19.81|15.41||||||||15.41|-19.81|
71079265|NCT01964989|141666166|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% confidence interval (CI) on the adjusted ratio of GMTs for HI antibody titer exceeds 1.|GMT ratio|1.91|||||TWO_SIDED|95.0|1.8|2.0||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for A/H1N1, D22/50 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||2.0|1.8|
71069322|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|2.635|||||TWO_SIDED|95.0|1.754|3.959||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.959|1.754|
71069323|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.467|||||TWO_SIDED|95.0|0.311|0.7||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.7|0.311|
71069324|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.309|||||TWO_SIDED|95.0|0.206|0.463||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.463|0.206|
71069325|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.8|||||TWO_SIDED|95.0|0.532|1.203||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||1.203|0.532|
71069326|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.662|||||TWO_SIDED|95.0|0.442|0.992||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.992|0.442|
71069327|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.714|||||TWO_SIDED|95.0|1.142|2.572||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.572|1.142|
71069328|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|Geometric mean ratio at day 22|2.589|||||TWO_SIDED|95.0|1.723|3.889||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.889|1.723|
71069329|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|4.975|||||TWO_SIDED|95.0|3.757|6.589||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||6.589|3.757|
71113132|NCT00368745|141733971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.38||0.5104||95.0|-1.03|0.52||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 4||0.52|-1.03|0.5104
71069330|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|1.168|||||TWO_SIDED|95.0|0.881|1.547||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.547|0.881|
71113133|NCT00368745|141733971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.43||0.2702||95.0|-1.35|0.39||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 5||0.39|-1.35|0.2702
71113134|NCT00368745|141733971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.42||0.1241||95.0|-1.52|0.19||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 6||0.19|-1.52|0.1241
71113135|NCT00368745|141733971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.36||0.0109||95.0|-1.67|-0.22||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Endpoint \[LOCF\]||-0.22|-1.67|0.0109
71113136|NCT00368745|141733972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.28||0.0226||95.0|-1.22|-0.09||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Taper (AT) Week 1||-0.09|-1.22|0.0226
71113137|NCT00368745|141733972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.34||0.0099||95.0|-1.58|-0.22||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 2||-0.22|-1.58|0.0099
71113138|NCT00368745|141733972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.35||0.2827||95.0|-1.07|0.32||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 3||0.32|-1.07|0.2827
71113139|NCT00368745|141733972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.58||0.8232||95.0|-1.07|1.34||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 4||1.34|-1.07|0.8232
71113140|NCT00368745|141733972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.66||0.2409||95.0|-2.41|0.72||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 5||0.72|-2.41|0.2409
71113141|NCT00368745|141733972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.61||0.476||95.0|-1.73|0.84||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 6||0.84|-1.73|0.4760
71113142|NCT00368745|141733972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.32||0.1252||95.0|-1.14|0.14||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Free (AF) Week 1||0.14|-1.14|0.1252
71113143|NCT00368745|141733972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.33||0.0717||95.0|-1.26|0.06||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 2||0.06|-1.26|0.0717
70941990|NCT02507687|141384384|NON_INFERIORITY|"Statistical non-inferiority of Bimatoprost SR 10 µg to SLT was demonstrated if the upper limit of the 95% confidence interval (CI) for the least squares (LS) mean difference between the Bimatoprost SR 10 µg eyes and SLT eyes was ≤ 1.5 mmHg at Weeks 4, 12, and 24.~Clinical non-inferiority of Bimatoprost SR 10 µg to SLT was considered if the upper limit of the 95% CI was ≤ 1.0 mmHg at 2 out of the 3 visits of Weeks 4, 12, and 24."|LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.24||0.0231|TWO_SIDED|95.0|-1.03|-0.08|||Mixed Effect Model Repeated Measurement|The model includes treatment, visit, eye, baseline IOP, treatment-by-visit, visit-by-baseline, and visit-by-eyes interactions as covariates.||||-0.08|-1.03|0.0231
71113144|NCT00368745|141733972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.35||0.0707||95.0|-1.33|0.06||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 3||0.06|-1.33|0.0707
71113145|NCT00368745|141733972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.39||0.4341||95.0|-1.08|0.47||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 4||0.47|-1.08|0.4341
71113146|NCT00368745|141733972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.42||0.37||95.0|-1.23|0.47||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 5||0.47|-1.23|0.3700
71113147|NCT00368745|141733972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|0.43||0.0328||95.0|-1.83|-0.08||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 6||-0.08|-1.83|0.0328
71113148|NCT00368745|141733972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|0.39||0.0096||95.0|-1.8|-0.26||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Endpoint \[LOCF\]||-0.26|-1.80|0.0096
71113149|NCT00368745|141733973|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|2.68||0.8897||95.0|-5.74|4.99||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as the covariate||||4.99|-5.74|0.8897
71113150|NCT00368745|141733974|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0626||95.0||||p-value is from the log-rank statistic from the tests for equality over treatment as strata and country used as covariate|Log Rank|||||||0.0626
71069331|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.88|||||TWO_SIDED|95.0|0.665|1.166||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.166|0.665|
71069332|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|3.219|||||TWO_SIDED|95.0|2.43|4.264||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||4.264|2.430|
71069333|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|1.07|||||TWO_SIDED|95.0|0.808|1.417||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.417|0.808|
71069334|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.72|||||TWO_SIDED|95.0|0.544|0.954||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.954|0.544|
71069335|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|2.509|||||TWO_SIDED|95.0|1.891|3.33||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.330|1.891|
71069336|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.235|||||TWO_SIDED|95.0|0.178|0.31||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.310|0.178|
71069337|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.177|||||TWO_SIDED|95.0|0.134|0.234||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.234|0.134|
71069338|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.647|||||TWO_SIDED|95.0|0.489|0.856||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.856|0.489|
71069339|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.215|||||TWO_SIDED|95.0|0.163|0.284||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.284|0.163|
71113151|NCT00368745|141733975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0148||95.0||||p-value is from the log-rank statistic from the tests for equality over treatment as strata and country used as covariate|Log Rank|||||||0.0148
71113152|NCT00368745|141733976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1159||95.0||||p-value is obtained using Cochran-Mantel-Haenszel option|Cochran-Mantel-Haenszel|||||||0.1159
71113153|NCT03037476|141733977|OTHER|General Linear Model|Slope|-0.235||||0.03|TWO_SIDED|95.0|-0.446|-0.023|||Mixed Models Analysis|Negative Binomial Regression||Changes from Baseline to 6 Month Follow-up Outcomes reported in this section.||-.023|-.446|0.03
71113154|NCT03037476|141733977|OTHER|General Linear Model|Slope|-0.149||||0.164|TWO_SIDED|95.0|-0.36|0.061|||Mixed Models Analysis|Negative Binomial Regression||Changes from Baseline to 12 Month Follow-up reported in this section.||.061|-.360|0.164
71113155|NCT03037476|141733978|OTHER|General Linear Model|Slope|-0.24||||0.603|TWO_SIDED|95.0|-1.12|0.65|||Mixed Models Analysis|Poisson Regression||Change in Medical Misuse of Prescription Stimulant Medication Among those with ADHD Diagnosis from Baseline to 6 Month Followup||.650|-1.120|.603
71028609|NCT02906709|141564863|SUPERIORITY||Difference in the Least Squares Means|-15.0||||0.002|TWO_SIDED|95.0|-24.5|-5.4|||Constrained Longitudinal Data Analysis||||Based on a Constrained Longitudinal Data Analysis model with terms for treatment, prior AHA therapy status (yes/no), time and the interaction of time by treatment, time by prior AHA therapy status and time by treatment by prior AHA status with the restriction of a common baseline mean between two treatment groups.|-5.4|-24.5|0.002
71028610|NCT02906709|141564864|SUPERIORITY||Percent Between-group Rate Difference|5.8||||0.065|TWO_SIDED|95.0|-0.7|11.5|||Miettinen & Nurminen method||||The estimated response rates and effective sample sizes were used to obtain the confidence intervals (CIs) for within-group response rates via the Wilson score method. The CI were calculated via the stratified (non-combination prior AHA therapy status) Miettinen \& Nurminen method.|11.5|-0.7|0.065
71028611|NCT02906709|141564865|SUPERIORITY||Percent Between-group Rate Difference|1.6||||0.334|TWO_SIDED|95.0|-4.7|5.8|||Miettinen & Nurminen method||||The estimated response rates and effective sample sizes were used to obtain the confidence intervals (CIs) for within-group response rates via the Wilson score method. The CI were calculated via the stratified (non-combination prior AHA therapy status) Miettinen \& Nurminen method.|5.8|-4.7|0.334
71028612|NCT02906709|141564866|SUPERIORITY||Difference in the Least Squares Means|3.1|||<|0.001|TWO_SIDED|95.0|2.3|4.0|||Constrained Longitudinal Data Analysis||||Based on a Constrained Longitudinal Data Analysis model with terms for treatment, prior AHA therapy status (yes/no), time and the interaction of time by treatment, time by prior AHA therapy status and time by treatment by prior AHA status with the restriction of a common baseline mean between two treatment groups.|4.0|2.3|<0.001
71028613|NCT03312257|141564951|OTHER|Repeated measures analyses using mixed linear models in STATA (version 15) were undertaken to model myopia progression (primary outcome) and axial elongation (secondary outcome) to account for the clusters of correlated data due to repeated participant outcome measures.|Mean Difference (Final Values)|0.03||||0.7|TWO_SIDED|95.0|-0.14|0.21|||Repeated measures analyses|||||0.21|-0.14|0.70
71028614|NCT03312257|141564952|OTHER|Repeated measures analyses using mixed linear models in STATA (version 15) were undertaken to model myopia progression (primary outcome) and axial elongation (secondary outcome) to account for the clusters of correlated data due to repeated participant outcome measures.|Mean Difference (Final Values)|-0.08||||0.054|TWO_SIDED|95.0|-0.16|0.002|||Repeated measures analyses|||||0.002|-0.16|0.054
71028615|NCT00449150|141564953|SUPERIORITY_OR_OTHER||LS means estimate|-0.198||||0.7424|TWO_SIDED|95.0|-1.38|0.98|||ANOVA|||||0.98|-1.38|0.7424
71028616|NCT00449150|141564953|SUPERIORITY_OR_OTHER||LS means estimate|0.055||||0.926||95.0|-1.1|1.21|||ANOVA|||||1.21|-1.10|0.926
71028617|NCT00449150|141564953|SUPERIORITY_OR_OTHER||LS means estimate|-0.252||||0.6699||95.0|-1.41|0.91|||ANOVA|||||0.91|-1.41|0.6699
71028618|NCT02674334|141564956|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.16|STANDARD_ERROR_OF_MEAN|0.83||0.165|TWO_SIDED|95.0|-0.49|2.82||P-values were not adjusted for multiple inferences|ANOVA|Continuous responses were tested using RCB ANOVA.||||2.82|-.49|0.165
71028619|NCT03552757|141564957|SUPERIORITY||Treatment difference|-6.21|||<|0.0001|TWO_SIDED|95.0|-7.28|-5.15|||ANCOVA|||Results are based on the data from in-trial observation period. Week 68 responses were analysed using an analysis of covariance model (ANCOVA) with randomised treatment, stratification groups (oral anti-diabetic (OAD) treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate.||-5.15|-7.28|<0.0001
71028620|NCT03552757|141564957|SUPERIORITY||Treatment difference|-7.57|||<|0.0001|TWO_SIDED|95.0|-8.56|-6.58|||MMRM|||Results are based on the data from on-treatment observation period. All responses prior to first discontinuation of treatment (or initiation of other anti-obesity medication or bariatric surgery) were included in a mixed model for repeated measurements (MMRM) with randomised treatment, stratification groups (OAD treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate, all nested within visit.||-6.58|-8.56|<0.0001
71028621|NCT03552757|141564958|SUPERIORITY||Odds Ratio (OR)|4.88|||<|0.0001|TWO_SIDED|95.0|3.58|6.64|||Regression, Logistic|||Results are based on the data from in-trial observation period. Week 68 responses were analysed using a binary logistic regression model with randomised treatment, stratification groups (OAD treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate.||6.64|3.58|<0.0001
71028622|NCT03552757|141564958|SUPERIORITY||Odds Ratio (OR)|8.69|||<|0.0001|TWO_SIDED|95.0|6.31|11.97|||Regression, Logistic|||Results are based on the data from on-treatment observation period. All responses prior to first discontinuation of treatment (or initiation of other anti-obesity medication or bariatric surgery) were included in a MMRM with randomised treatment, stratification groups (OAD treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate, all nested within visit.||11.97|6.31|<0.0001
71028623|NCT02660242|141565007|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Mixed model w/ repeated measures to account for correlation from cross-over design and multiple measures, adjusting for baseline glucose and period.||The mini-dose glucagon (MDG) condition was compared with each of the conditions. In the event that exercise was terminated early due to glucose \<70 mg/dL and the participant was treated for hypoglycemia (or if participant was treated for hypoglycemia during early recovery \[prior to the meal\]), the nadir glucose value was carried forward through the end of early recovery.||||<0.001
71028624|NCT02660242|141565008|OTHER|||||||0.99|||||||Mixed Models Analysis|Adjusted for subject effect, exercise session, and baseline blood glucose||||||0.99
71028625|NCT02660242|141565009|SUPERIORITY|||||||0.15|||||||Mixed Models Analysis|Adjusted for subject effect, exercise session, and baseline blood glucose||||||0.15
71028626|NCT02660242|141565010|SUPERIORITY|||||||0.99|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.99
71028627|NCT02660242|141565011|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.43
71028628|NCT02660242|141565012|SUPERIORITY|||||||0.16|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.16
71028629|NCT02660242|141565013|SUPERIORITY|||||||0.69|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.69
71069340|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.145||||||95.0|0.109|0.191||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.191|0.109|
71069341|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.504|||||TWO_SIDED|95.0|0.381|0.668||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.668|0.381|
71069342|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.754|||||TWO_SIDED|95.0|0.57|0.997||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.997|0.570|
71113156|NCT03037476|141733978|OTHER|General Linear Model|Slope|-0.336||||0.465|TWO_SIDED|95.0|-1.238|0.566|||Mixed Models Analysis|Poisson Regression||Change in Medical Misuse of Prescription Stimulant Medication Among those with ADHD Diagnosis from Baseline to 12 Month Followup||.566|-1.238|.465
71113157|NCT03037476|141733979|OTHER|General Linear Model|Slope|-0.059||||0.486|TWO_SIDED|95.0|-0.227|0.108|||Mixed Models Analysis|Negative Binomial Regression||Change in Past 12 Month Tobacco Use from Baseline to 6 Month Followup||.108|-.227|.486
71113158|NCT03037476|141733979|OTHER|General Linear Model|Slope|0.006||||0.942|TWO_SIDED|95.0|-0.16|0.172|||Mixed Models Analysis|Negative Binomial Regression||Change in Past 12 Month Tobacco Use from Baseline to 12 Month Followup||.172|-.160|.942
71113159|NCT03037476|141733979|OTHER|General Linear Model|Slope|-0.042||||0.552|TWO_SIDED|95.0|-0.18|0.097|||Mixed Models Analysis|Poisson Regression||Change in Past 12 Month Alcohol Use from Baseline to 6 Month Followup||.097|-.180|.552
71113160|NCT03037476|141733979|OTHER|General Linear Model|Slope|0.037||||0.608|TWO_SIDED|95.0|-0.104|0.177|||Mixed Models Analysis|Poisson Regression||Change in Past 12 Month Alcohol Use from Baseline to 12 Month Followup||.177|-.104|.608
71113161|NCT03037476|141733979|OTHER|General Linear Model|Slope|0.015||||0.84|TWO_SIDED|95.0|-0.13|0.16|||Mixed Models Analysis|Poisson Regression||Change in Past 12 Month Other Drug Use from Baseline to 6 Month Followup||.160|-.130|.840
71113162|NCT03037476|141733979|OTHER|General Linear Model|Slope|0.007||||0.927|TWO_SIDED|95.0|-0.142|0.155|||Mixed Models Analysis|Poisson Regression||Change in Past 12 Month Other Drug Use from Baseline to 12 Month Followup||.155|-.142|.927
71113163|NCT03037476|141733979|OTHER|General Linear Model|Slope|-0.01||||0.932|TWO_SIDED|95.0|-0.244|0.223|||Mixed Models Analysis|Poisson Regression||Change in Past 12 Month Nonmedical Prescription Drug Use from Baseline to 6 Month Followup||.223|-.244|.932
71113164|NCT03037476|141733979|OTHER|General Linear Model|Slope|-0.057||||0.648|TWO_SIDED|95.0|-0.3|0.187|||Mixed Models Analysis|Poisson Regression||Change in Past 12 Month Nonmedical Prescription Drug Use from Baseline to 12 Month Followup||0.187|-.300|.648
71113165|NCT03037476|141733979|OTHER|General Linear Model|Slope|-0.059||||0.702|TWO_SIDED|95.0|-0.363|0.245|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Tobacco Use from Baseline to 6 Month Followup||.245|-.363|.702
71113166|NCT03037476|141733979|OTHER|General Linear Model|Slope|-0.1||||0.524|TWO_SIDED|95.0|-0.408|0.208|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Tobacco Use from Baseline to 12 Month Followup||.208|-.408|.524
71113167|NCT03037476|141733979|OTHER|General Linear Model|Slope|0.008||||0.913|TWO_SIDED|95.0|-0.137|0.153|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Alcohol Use from Baseline to 6 Month Followup||.153|-.137|.913
71113168|NCT03037476|141733979|OTHER|General Linear Model|Slope|0.032||||0.676|TWO_SIDED|95.0|-0.117|0.181|||Mixed Models Analysis|Poisson Regresision||Change in Past 3 Month Alcohol Use from Baseline to 12 Month Followup||.181|-.117|.676
71113169|NCT03037476|141733979|OTHER|General Linear Model|Slope|-0.035||||0.712|TWO_SIDED|95.0|-0.223|0.152|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Marijuana Use from Baseline to 6 Month Followup||.152|-.223|.712
71113170|NCT03037476|141733979|OTHER|General Linear Model|Slope|0.005||||0.956|TWO_SIDED|95.0|-0.186|0.197|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Marijuana Use from Baseline to 12 Month Followup||0.197|-.186|.956
71113171|NCT03037476|141733979|OTHER|General Linear Model|Slope|0.149||||0.446|TWO_SIDED|95.0|-0.234|0.531|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Stimulant Use from Baseline to 6 Month Followup||.531|-.234|.446
71113172|NCT03037476|141733979|OTHER|General Linear Model|Slope|0.055||||0.793|TWO_SIDED|95.0|-0.353|0.462|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Stimulant Use from Baseline to 12 Month Followup||.462|-.353|.793
71113173|NCT03037476|141733979|OTHER|General Linear Model|Slope|-0.001||||0.999|TWO_SIDED|95.0|-2.005|2.003|||Mixed Models Analysis|Negative Binomial Regression||Change in Past 3 Month Heroin Use from Baseline to 6 Month Followup||2.003|-2.005|.999
71113174|NCT03037476|141733979|OTHER|General Linear Model|Slope|0.999||||0.397|TWO_SIDED|95.0|-1.312|3.31|||Mixed Models Analysis|Negative Binomial Regression||Change in Past 3 Month Heroin Use from Baseline to 12 Month Followup||3.310|-1.312|.397
71028630|NCT02660242|141565014|SUPERIORITY|||||||0.67|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.67
71028631|NCT02660242|141565015|SUPERIORITY|||||||0.84|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.84
71028632|NCT02660242|141565016|SUPERIORITY|||||||0.63|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.63
71028633|NCT02660242|141565017|SUPERIORITY|||||||0.24|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.24
71028634|NCT02660242|141565018|SUPERIORITY|||||||0.26|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.26
71028635|NCT01345019|141565022|NON_INFERIORITY|A two-stage approach was used for the non-inferiority test. First, the fixed margin approach was used to ensure denosumab has an effect greater than placebo (ie, the non-inferiority margin M1, ie, the lower bound of the two-sided 95% confidence interval 1.28, is ruled out). Next, a synthesis method was used for the non-inferiority test of the hypothesis that denosumab preserved at least 50% of the effect of zoledronic acid (HR \[95% CI\] of 1.48 \[1.28, 1.71\] for placebo vs zoledronic acid.|Hazard Ratio (HR)|0.98||||0.01|TWO_SIDED|95.0|0.85|1.14|||Cox proportional hazards model|Based on a Cox proportional hazards model stratified by the randomization stratification factors.|A hazard ratio (denosumab:zoledronic acid) \< 1 favors denosumab|||1.14|0.85|0.010
71028636|NCT01345019|141565025|SUPERIORITY|The statistical inferences of the treatment effect on secondary efficacy endpoints (time to the first on study SRE \[superiority\] and time to first and subsequent on study SRE \[superiority, multiple event analysis\]) were to be conducted if denosumab was determined to be non-inferior to zoledronic acid. To control the overall type I error for multiple comparisons at a significant level of 0.05, these secondary efficacy endpoints were tested simultaneously using the Hochberg procedure.||||||0.82|||||||Log Rank|Based on a log rank test stratified by randomization stratification factors.||||||0.82
71028637|NCT01345019|141565026|SUPERIORITY|The statistical inferences of the treatment effect on secondary efficacy endpoints (time to the first on study SRE \[superiority\] and time to first and subsequent on study SRE \[superiority, multiple event analysis\]) were to be conducted if denosumab was determined to be non-inferior to zoledronic acid. To control the overall type I error for multiple comparisons at a significant level of 0.05, these secondary efficacy endpoints were tested simultaneously using the Hochberg procedure.|Rate ratio|1.01||||0.84|TWO_SIDED|95.0|0.89|1.15|||Andersen-Gill model|Based on an Andersen-Gill model stratified by the randomization stratification factors.|A rate ratio (denosumab:zoledronic acid) \< 1 favors denosumab.|||1.15|0.89|0.84
71028638|NCT01345019|141565028|SUPERIORITY|If superiority of denosumab over zoledronic acid was established for both time to first SRE and time to first and subsequent SRE, the additional secondary endpoint (overall survival) was to be tested at a significance level of 0.05.|Hazard Ratio (HR)|0.9||||0.41|TWO_SIDED|95.0|0.7|1.16|||Cox proportional hazards model||A hazard ratio (denosumab:zoledronic acid) \< 1 favors denosumab.|The survival function of time to death for each treatment group was estimated using Kaplan-Meier method and the hazard ratio of denosumab compared with zoledronic acid and its 2-sided 95% CI were estimated using a Cox proportional hazards model stratified by the randomization stratification factors and including treatment groups, age, race group, geographic region, baseline creatinine clearance, baseline risk per cytogenetic based prognosis, and baseline ECOG as independent variables.||1.16|0.70|0.41
71028639|NCT00235456|141565030|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.61||||0.04|TWO_SIDED|95.0|0.38|0.98|||Chi-squared|||||0.98|0.38|0.04
71028640|NCT00235456|141565031|SUPERIORITY_OR_OTHER|||||||0.54|||||||t-test, 2 sided|||||||0.54
71028641|NCT00235456|141565032|SUPERIORITY_OR_OTHER|||||||0.28|||||||t-test, 2 sided|||||||0.28
71028642|NCT00235456|141565033|SUPERIORITY_OR_OTHER|||||||0.57|||||||t-test, 2 sided|||||||0.57
71028643|NCT00235456|141565034|SUPERIORITY_OR_OTHER|||||||0.71|||||||t-test, 2 sided|||||||0.71
71028644|NCT00235456|141565035|SUPERIORITY_OR_OTHER|||||||0.09|||||||t-test, 2 sided|||||||0.09
71028645|NCT00386009|141565039|SUPERIORITY_OR_OTHER|||||||0.068||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.068
71028646|NCT00386009|141565040|SUPERIORITY_OR_OTHER|||||||0.626||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.626
71028647|NCT00386009|141565041|SUPERIORITY_OR_OTHER|||||||0.113||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.113
71028648|NCT00386009|141565042|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.837
71028649|NCT00386009|141565043|SUPERIORITY_OR_OTHER|||||||0.4||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.400
71028650|NCT00386009|141565044|SUPERIORITY_OR_OTHER|||||||0.864||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.864
71028651|NCT00386009|141565045|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.340
71028652|NCT00386009|141565046|SUPERIORITY_OR_OTHER|||||||0.838||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.838
71028653|NCT00386009|141565047|SUPERIORITY_OR_OTHER|||||||0.609||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.609
71028654|NCT00386009|141565048|SUPERIORITY_OR_OTHER|||||||0.427||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.427
71028655|NCT00386009|141565049|SUPERIORITY_OR_OTHER|||||||0.838||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.838
71069343|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|2.756|||||TWO_SIDED|95.0|2.083|3.647||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.647|2.083|
71069344|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.916|||||TWO_SIDED|95.0|0.694|1.211||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.211|0.694|
71069345|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.616|||||TWO_SIDED|95.0|0.466|1.815||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.815|0.466|
71069346|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|2.149|||||TWO_SIDED|95.0|1.624|2.843||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.843|1.624|
71069347|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|3.656|||||TWO_SIDED|95.0|2.764|4.836||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||4.836|2.764|
71069348|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|1.216|||||TWO_SIDED|95.0|0.92|1.606||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.606|0.920|
71069349|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.818|||||TWO_SIDED|95.0|0.619|1.081||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.081|0.619|
71079266|NCT01964989|141666166|OTHER||GMT ratio|1.86|||||TWO_SIDED|95.0|1.7|2.0||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for A/H1N1, D181/209 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||2.0|1.7|
71079267|NCT01964989|141666166|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% CI on the adjusted ratio of GMTs for HI antibody titer exceeds 1.|GMT ratio|1.71|||||TWO_SIDED|95.0|1.6|1.8||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for A/H3N2, D22/50 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||1.8|1.6|
71079268|NCT01964989|141666166|OTHER||GMT ratio|1.57|||||TWO_SIDED|95.0|1.4|1.7||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for A/H3N2, D181/209 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||1.7|1.4|
71113175|NCT03037476|141733979|OTHER|General Linear Model|Slope|0.465||||0.303|TWO_SIDED|95.0|-0.419|1.349|||Mixed Models Analysis|Negative Binomial Regression||Change in Past 3 Month Nonmedical Prescription Drug Use from Baseline to 6 Month Followup||1.349|-.419|.303
71113176|NCT03037476|141733979|OTHER|General Linear Model|Slope|0.939|||<|0.05|TWO_SIDED|95.0|0.128|1.751|||Mixed Models Analysis|Negative Binomial Regression||Change in Past 3 Month Nonmedical Prescription Drug Use from Baseline to 12 Month Followup||1.751|.128|<.05
71113177|NCT03037476|141733980|OTHER|General Linear Model|Slope|-0.1816||||0.151|TWO_SIDED|95.0|-0.4295|0.0663|||Mixed Models Analysis|Negative binomial regression||Change in ASSIST Score over time: 6 month follow up||0.0663|-0.4295|0.151
71113178|NCT03037476|141733980|OTHER|General Linear Model|Slope|-0.0601||||0.642|TWO_SIDED|95.0|-0.3133|0.1931|||Mixed Models Analysis|Negative Binomial Regression||Changes in ASSIST scores at 12 month follow up||0.1931|-0.3133|0.642
71113179|NCT03037476|141733981|OTHER|General Linear Model|Slope|-0.2177||||0.074|TWO_SIDED|95.0|-0.4566|0.0213|||Mixed Models Analysis|Negative Binomial Regression||Change in consequence score at 6 month follow up||0.0213|-0.4566|0.074
71113180|NCT03037476|141733981|OTHER|General Linear Model|Slope|-0.1165||||0.351|TWO_SIDED|95.0|-0.3612|0.1282|||Mixed Models Analysis|Negative Binomial Regression||Change in consequence score at 12 month follow up||0.1282|-0.3612|0.351
71113181|NCT03037476|141733982|OTHER|General Linear Model|Slope|0.044||||0.255|TWO_SIDED|95.0|-0.032|0.1197|||Mixed Models Analysis|Negative Binomial Regression||Change in peak alcohol quantity at 6 months (reported by number of standard drinks)||0.1197|-0.032|0.255
71028656|NCT00386009|141565050|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.090
71028657|NCT00386009|141565051|SUPERIORITY_OR_OTHER|||||||0.113||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.113
71028658|NCT00386009|141565054|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||<0.001
71028659|NCT00320112|141565077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.004|TWO_SIDED|||||no differences between arms in baseline characteristics at \<0.1 level, further analyses adjusted for variables that could influence the outcome like insulin use, age, commodities. because no differences in results, unadjusted analyses are reported.|Regression, Linear|we used STATA 11's xtmixed command, which fits multi-level mixed-effects linear regression models, with clustering by assigned pairs.||||||0.004
71028660|NCT00320112|141565078|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED|||||this is a priori design|Regression, Linear|||||||.91
71028661|NCT00320112|141565079|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Regression, Linear|||||||0.10
71028662|NCT00320112|141565080|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Regression, Linear|||||||0.02
71028663|NCT02899338|141565081|EQUIVALENCE|The relative bioavailability of BI 695501 using AI (A) compared with BI 695501 using PFS (B) was estimated, in an exploratory manner, by the ratios of the geometric means (A/B) using the analysis of variance (ANOVA)|Adjusted geometric mean ratio|101.71|STANDARD_ERROR_OF_MEAN|42.28|||TWO_SIDED|90.0|91.31|113.29|||ANOVA|The results are based on ANOVA model on the logarithmic scale with fixed effects for treatment and baseline body weight.|Standard error of the mean is actually the Inter-individual geometric coefficient of variation (gCV)|Comparison AI versus PFS||113.29|91.31|
71028664|NCT02899338|141565082|EQUIVALENCE|The relative bioavailability of BI 695501 using AI (A) compared with BI 695501 using PFS (B) was estimated, in an exploratory manner, by the ratios of the geometric means (A/B) using ANOVA|Adjusted geometric mean ratio|100.11|STANDARD_ERROR_OF_MEAN|23.72|||TWO_SIDED|90.0|94.17|106.43|||ANOVA|The results are based on ANOVA model on the logarithmic scale with fixed effects for treatment and baseline body weight.|Standard error of the mean is actually the Inter-individual gCV|Comparison AI versus PFS||106.43|94.17|
71028665|NCT02899338|141565083|EQUIVALENCE|The relative bioavailability of BI 695501 using AI (A) compared with BI 695501 using PFS (B) was estimated, in an exploratory manner, by the ratios of the geometric means (A/B) using ANOVA|Adjusted geometric mean ratio|103.19|STANDARD_ERROR_OF_MEAN|48.21|||TWO_SIDED|90.0|91.38|116.53|||ANOVA|The results are based on ANOVA model on the logarithmic scale with fixed effects for treatment and baseline body weight.|Standard error of the mean is actually the Inter-individual gCV|Comparison AI versus PFS||116.53|91.38|
71028666|NCT02933866|141565096|SUPERIORITY|||||||0.2961|||||||Cochran-Mantel-Haenszel|||||||0.2961
71028667|NCT00577460|141565098|SUPERIORITY_OR_OTHER|||||||0.0039||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) with factors treatment and country and covariate OL baseline||PPX ER versus Placebo||||0.0039
71028668|NCT00577460|141565098|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) with factors treatment and country and covariate OL baseline||PPX IR versus Placebo||||0.0001
71028669|NCT00577460|141565101|SUPERIORITY_OR_OTHER|||||||0.559||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.5590
71028670|NCT00577460|141565101|SUPERIORITY_OR_OTHER|||||||0.1289||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.1289
71028671|NCT00577460|141565103|SUPERIORITY_OR_OTHER|||||||0.1073||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.1073
71028672|NCT00577460|141565103|SUPERIORITY_OR_OTHER|||||||0.8694||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.8694
71028673|NCT00577460|141565104|SUPERIORITY_OR_OTHER|||||||0.0009||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0009
71028674|NCT00577460|141565104|SUPERIORITY_OR_OTHER|||||||0.0573||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0573
71028675|NCT00577460|141565105|SUPERIORITY_OR_OTHER|||||||0.6434||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.6434
71028676|NCT00577460|141565105|SUPERIORITY_OR_OTHER|||||||0.2469||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.2469
71028677|NCT00577460|141565106|SUPERIORITY_OR_OTHER|||||||0.9741||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.9741
71028678|NCT00577460|141565106|SUPERIORITY_OR_OTHER|||||||0.762||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.7620
71069350|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|2.85|||||TWO_SIDED|95.0|2.152|3.773||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.773|2.152|
71069351|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.332|||||TWO_SIDED|95.0|0.251|0.44||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.440|0.251|
71069352|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.224|||||TWO_SIDED|95.0|0.169|0.296||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.296|0.169|
71069353|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.78|||||TWO_SIDED|95.0|0.588|1.003||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.003|0.588|
71069354|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.673|||||TWO_SIDED|95.0|0.509|0.889||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.889|0.509|
71069355|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|2.345|||||TWO_SIDED|95.0|1.772|3.102||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.102|1.772|
71069356|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|3.485|||||TWO_SIDED|95.0|2.633|4.614||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||4.614|2.633|
71069357|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|2.624|||||TWO_SIDED|95.0|1.817|3.789||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.789|1.817|
71113182|NCT03037476|141733982|OTHER|General Linear Model|Slope|0.0315||||0.428|TWO_SIDED|95.0|-0.0463|0.1092|||Mixed Models Analysis|Negative Binomial Regression||Change in peak alcohol quantity (reported in standard drinks) at 12 month follow-up||0.1092|-0.0463|0.428
71113183|NCT03037476|141733983|OTHER|General Linear Model|Slope|0.0021||||0.966|TWO_SIDED|95.0|-0.0936|0.0978|||Mixed Models Analysis|Negative Binomial Regression||Change in DDQ score at 6 months||0.0978|-0.0936|0.966
71113184|NCT03037476|141733983|OTHER|General Linear Model|Slope|-0.0559||||0.265|TWO_SIDED|95.0|-0.1542|0.0424|||Mixed Models Analysis|Negative Binomial Regression||Change in DDQ score at 12 month follow-up||0.0424|-0.1542|0.265
71069358|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.096|||||TWO_SIDED|95.0|0.76|1.58||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.580|0.760|
71113185|NCT03037476|141733984|OTHER|General Linear Model|Slope|-0.0128||||0.868|TWO_SIDED|95.0|-0.1633|0.1378|||Mixed Models Analysis|Negative Binomial Regression||Change in RAPI count at 6 month follow-up||0.1378|-0.1633|0.868
71113186|NCT03037476|141733984|OTHER|General Linear Model|Slope|-0.0445||||0.573|TWO_SIDED|95.0|-0.1993|0.1102|||Mixed Models Analysis|Negative Binomial Regression||Change in RAPI count at 12 month follow-up||0.1102|-0.1993|0.573
71028679|NCT00577460|141565110|SUPERIORITY_OR_OTHER|||||||0.0831||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0831
71028680|NCT00577460|141565110|SUPERIORITY_OR_OTHER|||||||0.0759||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0759
71028681|NCT00577460|141565111|SUPERIORITY_OR_OTHER|||||||0.1713||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.1713
71028682|NCT00577460|141565111|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0130
71028683|NCT00577460|141565112|SUPERIORITY_OR_OTHER|||||||0.0015||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0015
71028684|NCT00577460|141565112|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0002
71069359|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.888|||||TWO_SIDED|95.0|0.615|1.282||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.282|0.615|
71069360|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|2.12|||||TWO_SIDED|95.0|1.473|3.052||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.052|1.473|
71069361|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.876|||||TWO_SIDED|95.0|0.61|1.26||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.260|0.610|
71069362|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67|Geometric mean ratio at day 202|0.898|||||TWO_SIDED|95.0|0.622|1.298||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.298|0.622|
71069363|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.451|||||TWO_SIDED|95.0|1.0|2.105||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.105|1.000|
71069364|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.418|||||TWO_SIDED|95.0|0.289|0.603||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.603|0.289|
71069365|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.338|||||TWO_SIDED|95.0|0.235|0.487||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.487|0.235|
71069366|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.808|||||TWO_SIDED|95.0|0.561|1.165||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.165|0.561|
71069367|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.334|||||TWO_SIDED|95.0|0.233|0.479||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.479|0.233|
71069368|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.342|||||TWO_SIDED|95.0|0.237|0.494||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.494|0.237|
71069369|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.553|||||TWO_SIDED|95.0|0.382|0.801||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.801|0.382|
71113187|NCT03037476|141733985|OTHER|General Linear Model|Slope|-0.0899||||0.266|TWO_SIDED|95.0|-0.2484|0.0685|||Mixed Models Analysis|Negative Binomial Regression||Change in past 12 month marijuana use at 6 month follow-up||0.0685|-0.2484|0.266
71113188|NCT03037476|141733985|OTHER|General Linear Model|Slope|-0.0197||||0.816|TWO_SIDED|95.0|-0.1859|0.1465|||Mixed Models Analysis|Negative Binomial Regression||Past 12 month marijuana use at 12 month follow-up||0.1465|-0.1859|0.816
71113189|NCT03037476|141733985|OTHER|General Linear Model|Slope|-0.1031||||0.209|TWO_SIDED|95.0|-0.2639|0.0577|||Mixed Models Analysis|Negative Binomial Regression||Change in past 6 month marijuana use at 6 month follow-up||0.0577|-0.2639|0.209
71113190|NCT03037476|141733985|OTHER|General Linear Model|Slope|-0.006||||0.944|TWO_SIDED|95.0|-0.1729|0.1608|||Mixed Models Analysis|Negative Binomial Regression||Change in past 6 month marijuana use at 12 month follow-up||0.1608|-0.1729|0.944
71113191|NCT03037476|141733985|OTHER|General Linear Model|Slope|-0.0391||||0.654|TWO_SIDED|95.0|-0.2102|0.132|||Mixed Models Analysis|Negative Binomial Regression||Change in past month marijuana use at 6 month follow-up||0.1320|-0.2102|0.654
71113192|NCT03037476|141733985|OTHER|General Linear Model|Slope|-0.0646||||0.481|TWO_SIDED|95.0|-0.2444|0.1152|||Mixed Models Analysis|Negative Binomial Regression||Change in past month marijuana use at 12 month follow-up||0.1152|-0.2444|0.481
71113193|NCT03037476|141733986|OTHER|General Linear Model|Slope|-0.0411||||0.487|TWO_SIDED|95.0|-0.1569|0.0747|||Mixed Models Analysis|Negative Binomial Regression||Change in RMPI count at 6 month follow-up||0.0747|-0.1569|0.487
71113194|NCT03037476|141733986|OTHER|General Linear Model|Slope|0.0177||||0.772|TWO_SIDED|95.0|-0.1021|0.1375|||Mixed Models Analysis|Negative Binomial Regression||Change in RMPI count at 12 month follow-up||0.1375|-0.1021|0.772
71028685|NCT00577460|141565113|SUPERIORITY_OR_OTHER|||||||0.876||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.8760
71028686|NCT00577460|141565113|SUPERIORITY_OR_OTHER|||||||0.5113||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.5113
71028687|NCT00577460|141565114|SUPERIORITY_OR_OTHER|||||||0.0148||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0148
71028688|NCT00577460|141565114|SUPERIORITY_OR_OTHER|||||||0.0201||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0201
71028689|NCT04591626|141565129|SUPERIORITY||LS Mean Difference|-0.95|||<|0.001|TWO_SIDED|95.0|-1.14|-0.77|||Mixed Models Analysis|||||-0.77|-1.14|<0.001
71028690|NCT04591626|141565130|SUPERIORITY||Odds Ratio (OR)|10.91|||<|0.001|TWO_SIDED|95.0|5.35|22.28|||Regression, Logistic|||||22.28|5.35|<0.001
71028691|NCT04591626|141565131|SUPERIORITY||LS Mean Difference|-1.18|||<|0.001|TWO_SIDED|95.0|-1.77|-0.6|||Mixed Models Analysis|||||-0.60|-1.77|<0.001
71028692|NCT04591626|141565132|SUPERIORITY||LS Mean Difference|-14.82|||<|0.001|TWO_SIDED|95.0|-20.57|-9.08|||Mixed Models Analysis|||||-9.08|-20.57|<0.001
71028693|NCT04591626|141565133|SUPERIORITY||Odds Ratio (OR)|4.58|||<|0.001|TWO_SIDED|95.0|2.64|7.95|||Regression, Logistic||OR was determined using Logistic Regression model with Baseline HbA1c value + OAM use + Treatment as variables.|||7.95|2.64|<0.001
71028694|NCT04591626|141565134|SUPERIORITY||Odds Ratio (OR)|7.59|||<|0.001|TWO_SIDED|95.0|4.27|13.48|||Regression, Logistic||OR was determined using logistic regression model: Variable = Baseline HbA1c value + OAM use + Treatment as variables.|||13.48|4.27|<0.001
71028695|NCT04591626|141565135|SUPERIORITY||Odds Ratio (OR)|4.58|||<|0.001|TWO_SIDED|95.0|2.64|7.95|||Regression, Logistic||OR was determined using logistic regression model with Baseline HbA1c value + OAM use + Treatment as variables.|||7.95|2.64|<0.001
71028696|NCT04591626|141565136|SUPERIORITY||LS Mean Difference|-26.3|||<|0.001|TWO_SIDED|95.0|-33.0|-19.6|||Mixed Models Analysis|||||-19.6|-33.0|<0.001
71028697|NCT04591626|141565137|SUPERIORITY||LS Mean Difference|-4.0||||0.006|TWO_SIDED|95.0|-6.86|-1.14|||Mixed Models Analysis|||||-1.14|-6.86|0.006
71028698|NCT02672553|141565138|SUPERIORITY||Median Difference (Final Values)|-12.5|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71028699|NCT02672553|141565139|SUPERIORITY||Median Difference (Final Values)|-10.5||||0.2077|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.2077
71028700|NCT02405195|141565176|OTHER|||||||0.638||||||Bonferroni-Holm adjustment for multiple comparisons was used|ANOVA|||Repeated measures ANOVA throughout measurement period (before, during and after CPB).||||0.638
71028701|NCT02405195|141565177|OTHER|||||||0.972||||||Bonferroni-Holm adjustment for multiple comparisons was used|ANOVA|||Repeated measures ANOVA||||0.972
71028702|NCT02405195|141565178|OTHER||||||<|0.001||||||Bonferroni-Holm adjustment for multiple comparisons was used|ANOVA|||Repeated measures ANOVA||||<0.001
71028703|NCT01691248|141565184|SUPERIORITY_OR_OTHER||Percentage Difference|2.2||||0.2778|TWO_SIDED|95.0|-5.1|9.5||1-sided Wald test for a difference in proportions using an unpooled estimate of variance.|One-sided Wald p-value||Placebo minus Fidaxomicin|||9.5|-5.1|0.2778
71028704|NCT01691248|141565185|SUPERIORITY_OR_OTHER||Percentage difference|0.6||||0.442|TWO_SIDED|95.0|-7.1|8.2||1-sided Wald test for a difference in proportions using an unpooled estimate of variance.|One-sided Wald p-value||Placebo minus Fidaxomicin|||8.2|-7.1|0.4420
71069370|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.811|||||TWO_SIDED|95.0|0.562|1.169||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.169|0.562|
71069371|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.935|||||TWO_SIDED|95.0|1.347|2.78||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.780|1.347|
71069372|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.8|||||TWO_SIDED|95.0|0.558|1.147||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.147|0.558|
71069373|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.82|||||TWO_SIDED|95.0|0.568|1.184||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.184|0.568|
71069374|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.324|||||TWO_SIDED|95.0|0.915|1.917||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.917|0.915|
71079269|NCT01964989|141666166|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% CI on the adjusted ratio of GMTs for HI antibody titer exceeds 1.|GMT ratio|2.19|||||TWO_SIDED|95.0|2.0|2.4||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for B/YAM, D22/50 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||2.4|2.0|
71079270|NCT01964989|141666166|OTHER||GMT ratio|1.86|||||TWO_SIDED|95.0|1.7|2.0||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for B/YAM, D181/209 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||2.0|1.7|
71079271|NCT01964989|141666166|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% CI on the adjusted ratio of GMTs for HI antibody titer exceeds 1.|GMT ratio|2.27|||||TWO_SIDED|95.0|2.0|2.6||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for B/VIC, D22/50 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||2.6|2.0|
71079272|NCT01964989|141666166|OTHER||GMT ratio|1.8|||||TWO_SIDED|95.0|1.6|2.1||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for B/VIC, D181/209 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||2.1|1.6|
71079273|NCT01964989|141666168|OTHER||GMT ratio|0.92|||||TWO_SIDED|95.0|0.8|1.0||||||aQIV GMT ratio (High risk/Healthy) for A/H1N1 at D22/50 (Pooled Naïve \& Non-naïve).||1.0|0.8|
71113195|NCT03037476|141733987|OTHER|General Linear Model|Slope|0.1285||||0.075|TWO_SIDED|95.0|-0.0131|0.2702|||Mixed Models Analysis|Negative Binomial Regression||Change in PBS count at 6 month follow up||0.2702|-0.0131|0.075
71113196|NCT03037476|141733987|OTHER|General Linear Model|Slope|0.0936||||0.207|TWO_SIDED|95.0|-0.0517|0.2388|||Mixed Models Analysis|Negative Binomial Regression||Change in PBS count at 12 month follow up||0.2388|-0.0517|0.207
71113197|NCT03037476|141733988|OTHER|General Linear Model|Slope|-0.1604|||<|0.001|TWO_SIDED|95.0|-0.2525|-0.0683|||Mixed Models Analysis|Negative Binomial Regression||Change in perceived norm (in perceived days of use in past year) at 6 month follow up||-0.0683|-0.2525|<0.001
71113198|NCT03037476|141733988|OTHER|General Linear Model|Slope|-0.1441|||<|0.003|TWO_SIDED|95.0|-0.2404|-0.0478|||Mixed Models Analysis|Negative Binomial Regression||Change in perceived norm (perceived number of days of use in past year) at 12 month follow up||-0.0478|-0.2404|<.003
71113199|NCT03037476|141733989|OTHER|General Linear Model|Slope|-0.0157||||0.743|TWO_SIDED|95.0|-0.1096|0.0782|||Mixed Models Analysis|Poisson regression||Change in MSLQ score at 6 month follow-up||0.0782|-0.1096|0.743
71113200|NCT03037476|141733989|OTHER|General Linear Model|Slope|0.0133||||0.784|TWO_SIDED|95.0|-0.0816|0.1081|||Mixed Models Analysis|Poisson regression||Change in MSLQ score at 12 month follow up||0.1081|-0.0816|0.784
71113201|NCT03037476|141733990|OTHER|General Linear Model|Slope|-0.0061||||0.914|TWO_SIDED|95.0|-0.1161|0.104|||Mixed Models Analysis|Poisson regression||Change in cumulative grade point average at 6 month follow up||0.104|-0.1161|0.914
70852798|NCT02744040|141194418|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in integrated HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for integrated HIV DNA.||||<0.0001
71113202|NCT03037476|141733990|OTHER|General Linear Model|Slope|-0.0092||||0.871|TWO_SIDED|95.0|-0.1202|0.1018|||Mixed Models Analysis|General Linear Model||Change in cumulative grade point average at 12 month follow up||0.1018|-0.1202|0.871
71113203|NCT03037476|141733990|OTHER|General Linear Model|Slope|0.003||||0.957|TWO_SIDED|95.0|-0.1063|0.1124|||Mixed Models Analysis|Poisson regression||Change in last term GPA at 6 month follow-up||0.1124|-0.1063|0.957
71113204|NCT03037476|141733990|OTHER|General Linear Model|Slope|0.0006||||0.992|TWO_SIDED|95.0|-0.1098|0.1109|||Mixed Models Analysis|Poisson regression||Change in last term GPA at 12 month follow-up||0.1109|-0.1098|0.992
71113205|NCT03037476|141733991|OTHER|General Linear Model|Slope|0.039||||0.447|TWO_SIDED|95.0|-0.0615|0.1395|||Mixed Models Analysis|Negative Binomial Regression||Change in past month alcohol frequency at 6 month follow-up||0.1395|-.0615|0.447
71113206|NCT03037476|141733991|OTHER|General Linear Model|Slope|0.0398||||0.443|TWO_SIDED|95.0|-0.0619|0.1414|||Mixed Models Analysis|Negative Binomial Regression||Change in past month alcohol frequency at 12 month follow-up||0.1414|-0.0619|0.443
71113207|NCT03037476|141733992|OTHER|General Linear Model|Slope|0.0002||||0.997|TWO_SIDED|95.0|-0.1066|0.107|||Mixed Models Analysis|Negative Binomial Regression||Change in past month alcohol typical quantity at 6 months||0.1070|-0.1066|0.997
71113208|NCT03037476|141733992|OTHER|General Linear Model|Slope|-0.0136||||0.808|TWO_SIDED|95.0|-0.1236|0.0963|||Mixed Models Analysis|Negative Binomial Regression||Change in past month typical alcohol quantity at 12 month follow-up||0.0963|-0.1236|0.808
71113209|NCT01498692|141733996|SUPERIORITY_OR_OTHER||Percent Target Lesion Failure|2.4|||<|0.0001|ONE_SIDED|95.0||7.3|||One-group exact binomial test|||A one-group exact binomial test was used to test the hypothesis that the primary endpoint rate in the PROMUS Element cohort is less than the predefined performance goal of 21.1%.||7.3||<0.0001
71113210|NCT00282087|141734054|SUPERIORITY_OR_OTHER||Two year PFS|78.0||||0.15|TWO_SIDED|95.0|67.0|91.0|||Bayesian Posterior Probability|||The primary endpoint is progression-free survival time, with progression defined as a patient having evidence of recurrent LMS on follow-up evaluation and CT scan. Futility monitoring will be based on the accumulating right-censored PFS time data. The monitoring rules will be based on a Bayesian model.||91|67|0.15
71113211|NCT00282087|141734056|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|-0.00269|||||TWO_SIDED||||||Cox Proportional Hazards|||Age correlation with progression-free survival for patients on study treatment.||||
71079274|NCT01964989|141666168|OTHER||GMT ratio|1.02|||||TWO_SIDED|95.0|0.9|1.1||||||aQIV GMT ratio (High risk/Healthy) for A/H3N2 at D22/50 (Pooled Naïve \& Non-naïve).||1.1|0.9|
71079275|NCT01964989|141666168|OTHER||GMT ratio|0.98|||||TWO_SIDED|95.0|0.8|1.1||||||aQIV GMT ratio (High risk/Healthy) for B/YAM at D22/50 (Pooled Naïve \& Non-naïve).||1.1|0.8|
71079276|NCT01964989|141666168|OTHER||GMT ratio|0.92|||||TWO_SIDED|95.0|0.8|1.1||||||aQIV GMT ratio (High risk/Healthy) for B/VIC at D22/50 (Pooled Naïve \& Non-naïve).||1.1|0.8|
71028705|NCT01691248|141565186|SUPERIORITY_OR_OTHER||Percentage difference|1.9||||0.3091|TWO_SIDED|95.0|-5.5|9.2||1-sided Wald test for a difference in proportions using an unpooled estimate of variance.|One-sided Wald p-value||Placebo minus Fidaxomicin|||9.2|-5.5|0.3091
71028706|NCT02863575|141565187|SUPERIORITY||Least square (LS) means difference|2.68||||0.306|TWO_SIDED|95.0|-2.46|7.82|||ANCOVA|||||7.82|-2.46|0.306
71028707|NCT02863575|141565188|SUPERIORITY||LS mean difference|1.09||||0.056|TWO_SIDED|95.0|-0.03|2.2|||ANCOVA|||SPRID 0-2||2.20|-0.03|0.056
71028708|NCT02863575|141565188|SUPERIORITY||LS means difference|11.13|||<|0.001|TWO_SIDED|95.0|9.54|12.73|||ANCOVA|||SPRID 0-2||12.73|9.54|< 0.001
71028709|NCT02863575|141565188|SUPERIORITY||LS mean difference|10.05|||<|0.001|TWO_SIDED|95.0|8.45|11.64|||ANCOVA|||SPRID 0-2||11.64|8.45|< 0.001
71028710|NCT02863575|141565188|SUPERIORITY||LS mean difference|1.58||||0.177|TWO_SIDED|95.0|-0.72|3.87|||ANCOVA|||SPRID 0-4||3.87|-0.72|0.177
71028711|NCT02863575|141565188|SUPERIORITY||LS mean difference|24.04|||<|0.001|TWO_SIDED|95.0|20.76|27.32|||ANCOVA|||SPRID 0-4||27.32|20.76|< 0.001
71028712|NCT02863575|141565188|SUPERIORITY||LS mean difference|22.46|||<|0.001|TWO_SIDED|95.0|19.18|25.75|||ANCOVA|||SPRID 0-4||25.75|19.18|< 0.001
71028713|NCT02863575|141565188|SUPERIORITY||LS mean difference|2.39||||0.201|TWO_SIDED|95.0|-1.28|6.06|||ANCOVA|||SPRID 0-6||6.06|-1.28|0.201
71028714|NCT02863575|141565188|SUPERIORITY||LS mean difference|34.3|||<|0.001|TWO_SIDED|95.0|29.06|39.55|||ANCOVA|||SPRID 0-6||39.55|29.06|< 0.001
71028715|NCT02863575|141565188|SUPERIORITY||LS mean difference|31.91|||<|0.001|TWO_SIDED|95.0|26.67|37.16|||ANCOVA|||SPRID 0-6||37.16|26.67|< 0.001
71028716|NCT02863575|141565188|SUPERIORITY||LS mean difference|40.85|||<|0.001|TWO_SIDED|95.0|33.49|48.2|||ANCOVA|||SPRID 0-8||48.20|33.49|< 0.001
71028717|NCT02863575|141565188|SUPERIORITY||LS mean difference|38.17|||<|0.001|TWO_SIDED|95.0|30.81|45.52|||ANCOVA|||SPRID 0-8||45.52|30.81|< 0.001
71028718|NCT02863575|141565189|SUPERIORITY||LS means difference|0.73||||0.066|TWO_SIDED|95.0|-0.05|1.5|||ANCOVA|||SPID 0-2||1.50|-0.05|0.066
71028719|NCT02863575|141565189|SUPERIORITY||LS means difference|7.55|||<|0.001|TWO_SIDED|95.0|6.44|8.66|||ANCOVA|||SPID 0-2||8.66|6.44|< 0.001
71028720|NCT02863575|141565189|SUPERIORITY||LS means difference|6.82|||<|0.001|TWO_SIDED|95.0|5.71|7.93|||ANCOVA|||SPID 0-2||7.93|5.71|< 0.001
71028721|NCT02863575|141565189|SUPERIORITY||LS means difference|1.14||||0.165|TWO_SIDED|95.0|-0.47|2.74|||ANCOVA|||SPID 0-4||2.74|-0.47|0.165
71028722|NCT02863575|141565189|SUPERIORITY||LS means difference|16.35|||<|0.001|TWO_SIDED|95.0|14.05|18.64|||ANCOVA|||SPID 0-4||18.64|14.05|< 0.001
71028723|NCT02863575|141565189|SUPERIORITY||LS means difference|15.21|||<|0.001|TWO_SIDED|95.0|12.91|17.51|||ANCOVA|||SPID 0-4||17.51|12.91|< 0.001
71028724|NCT02863575|141565189|SUPERIORITY||LS means difference|1.78||||0.172|TWO_SIDED|95.0|-0.78|4.34|||ANCOVA|||SPID 0-6||4.34|-0.78|0.172
71028725|NCT02863575|141565189|SUPERIORITY||LS means difference|23.37|||<|0.001|TWO_SIDED|95.0|19.71|27.03|||ANCOVA|||SPID 0-6||27.03|19.71|< 0.001
71028726|NCT02863575|141565189|SUPERIORITY||LS means difference|21.59|||<|0.001|TWO_SIDED|95.0|17.93|25.25|||ANCOVA|||SPID 0-6||25.25|17.93|< 0.001
71028727|NCT02863575|141565189|SUPERIORITY||LS means difference|2.1||||0.249|TWO_SIDED|95.0|-1.47|5.67|||ANCOVA|||SPID 0-8||5.67|-1.47|0.249
71028728|NCT02863575|141565189|SUPERIORITY||LS means difference|27.88|||<|0.001|TWO_SIDED|95.0|22.78|32.99|||ANCOVA|||SPID 0-8||32.99|22.78|< 0.001
71028729|NCT02863575|141565189|SUPERIORITY||LS means difference|25.79|||<|0.001|TWO_SIDED|95.0|20.68|30.89|||ANCOVA|||SPID 0-8||30.89|20.68|< 0.001
71028730|NCT02863575|141565190|SUPERIORITY||LS means difference|0.36||||0.044|TWO_SIDED|95.0|0.01|0.71|||ANCOVA|||TOTPAR 0-2||0.71|0.01|0.044
71028731|NCT02863575|141565190|SUPERIORITY||LS means difference|3.59|||<|0.001|TWO_SIDED|95.0|3.09|4.09|||ANCOVA|||TOTPAR 0-2||4.09|3.09|< 0.001
71028732|NCT02863575|141565190|SUPERIORITY||LS means difference|3.23|||<|0.001|TWO_SIDED|95.0|2.73|3.73|||ANCOVA|||TOTPAR 0-2||3.73|2.73|< 0.001
71028733|NCT02863575|141565190|SUPERIORITY||LS means difference|0.44||||0.224|TWO_SIDED|95.0|-0.27|1.15|||ANCOVA|||TOTPAR 0-4||1.15|-0.27|0.224
71028734|NCT02863575|141565190|SUPERIORITY||LS means difference|7.69|||<|0.001|TWO_SIDED|95.0|6.68|8.71|||ANCOVA|||TOTPAR 0-4||8.71|6.68|< 0.001
71028735|NCT02863575|141565190|SUPERIORITY||LS means difference|7.25|||<|0.001|TWO_SIDED|95.0|6.23|8.27|||ANCOVA|||TOTPAR 0-4||8.27|6.23|< 0.001
71028736|NCT02863575|141565190|SUPERIORITY||LS means difference|0.61||||0.293|TWO_SIDED|95.0|-0.53|1.75|||ANCOVA|||TOTPAR 0-6||1.75|-0.53|0.293
71028737|NCT02863575|141565190|SUPERIORITY||LS means difference|10.93|||<|0.001|TWO_SIDED|95.0|9.3|12.56|||ANCOVA|||TOTPAR 0-6||12.56|9.30|< 0.001
71028738|NCT02863575|141565190|SUPERIORITY||LS means difference|10.32|||<|0.001|TWO_SIDED|95.0|8.69|11.95|||ANCOVA|||TOTPAR 0-6||11.95|8.69|< 0.001
71028739|NCT02863575|141565190|SUPERIORITY||LS means difference|0.58||||0.476|TWO_SIDED|95.0|-1.03|2.19|||ANCOVA|||TOTPAR 0-8||2.19|-1.03|0.476
71028740|NCT02863575|141565190|SUPERIORITY||LS means difference|12.96|||<|0.001|TWO_SIDED|95.0|10.66|15.26|||ANCOVA|||TOTPAR 0-8||15.26|10.66|< 0.001
71028741|NCT02863575|141565190|SUPERIORITY||LS means difference|12.38|||<|0.001|TWO_SIDED|95.0|10.08|14.68|||ANCOVA|||TOTPAR 0-8||14.68|10.08|< 0.001
71028742|NCT02863575|141565191|SUPERIORITY||LS means difference|0.01||||0.975|TWO_SIDED|95.0|-0.35|0.36|||ANCOVA|||PRID at 0.25 hour||0.36|-0.35|0.975
71028743|NCT02863575|141565191|SUPERIORITY||LS means difference|0.12||||0.654|TWO_SIDED|95.0|-0.4|0.63|||ANCOVA|||PRID at 0.25 hour||0.63|-0.40|0.654
71028744|NCT02863575|141565191|SUPERIORITY||LS means difference|0.11||||0.67|TWO_SIDED|95.0|-0.4|0.62|||ANCOVA|||PRID at 0.25 hour||0.62|-0.40|0.670
71028745|NCT02863575|141565191|SUPERIORITY||LS means difference|-0.04||||0.917|TWO_SIDED|95.0|-0.7|0.63|||ANCOVA|||PRID at 0.5 hour||0.63|-0.70|0.917
71028746|NCT02863575|141565191|SUPERIORITY||LS means difference|2.26|||<|0.001|TWO_SIDED|95.0|1.31|3.2|||ANCOVA|||PRID at 0.5 hour||3.20|1.31|< 0.001
71028747|NCT02863575|141565191|SUPERIORITY||LS means difference|2.29|||<|0.001|TWO_SIDED|95.0|1.35|3.24|||ANCOVA|||PRID at 0.5 hour||3.24|1.35|< 0.001
71028748|NCT02863575|141565191|SUPERIORITY||LS means difference|0.73||||0.039|TWO_SIDED|95.0|0.04|1.42|||ANCOVA|||PRID at 1 hour||1.42|0.04|0.039
71028749|NCT02863575|141565191|SUPERIORITY||LS means difference|6.11|||<|0.001|TWO_SIDED|95.0|5.12|7.1|||ANCOVA|||PRID at 1 hour||7.10|5.12|< 0.001
71028750|NCT02863575|141565191|SUPERIORITY||LS means difference|5.38|||<|0.001|TWO_SIDED|95.0|4.39|6.37|||ANCOVA|||PRID at 1 hour||6.37|4.39|< 0.001
71028751|NCT02863575|141565191|SUPERIORITY||LS means difference|0.84||||0.015|TWO_SIDED|95.0|0.16|1.52|||ANCOVA|||PRID at 1.5 hour||1.52|0.16|0.015
71028752|NCT02863575|141565191|SUPERIORITY||LS means difference|7.36|||<|0.001|TWO_SIDED|95.0|6.39|8.33|||ANCOVA|||PRID at 1.5 hour||8.33|6.39|< 0.001
71028753|NCT02863575|141565191|SUPERIORITY||LS means difference|6.52|||<|0.001|TWO_SIDED|95.0|5.55|7.49|||ANCOVA|||PRID at 1.5 hour||7.49|5.55|< 0.001
71028754|NCT02863575|141565191|SUPERIORITY||LS means difference|0.62||||0.071|TWO_SIDED|95.0|-0.05|1.3|||ANCOVA|||PRID at 2 hour||1.30|-0.05|0.071
71028755|NCT02863575|141565191|SUPERIORITY||LS means difference|7.62|||<|0.001|TWO_SIDED|95.0|6.65|8.58|||ANCOVA|||PRID at 2 hour||8.58|6.65|< 0.001
71028756|NCT02863575|141565191|SUPERIORITY||LS means difference|6.99|||<|0.001|TWO_SIDED|95.0|6.03|7.96|||ANCOVA|||PRID at 2 hour||7.96|6.03|< 0.001
71028757|NCT02863575|141565191|SUPERIORITY||LS means difference|0.41||||0.243|TWO_SIDED|95.0|-0.28|1.09|||ANCOVA|||PRID at 3 hour||1.09|-0.28|0.243
71028758|NCT02863575|141565191|SUPERIORITY||LS means difference|6.83|||<|0.001|TWO_SIDED|95.0|5.85|7.8|||ANCOVA|||PRID at 3 hour||7.80|5.85|< 0.001
71028759|NCT02863575|141565191|SUPERIORITY||LS means difference|6.42|||<|0.001|TWO_SIDED|95.0|5.44|7.4|||ANCOVA|||PRID at 3 hour||7.40|5.44|< 0.001
71028760|NCT02863575|141565191|SUPERIORITY||LS means difference|0.08||||0.823|TWO_SIDED|95.0|-0.65|0.82|||ANCOVA|||PRID at 4 hour||0.82|-0.65|0.823
71028761|NCT02863575|141565191|SUPERIORITY||LS means difference|6.08|||<|0.001|TWO_SIDED|95.0|5.02|7.14|||ANCOVA|||PRID at 4 hour||7.14|5.02|< 0.001
71028762|NCT02863575|141565191|SUPERIORITY||LS means difference|6.0|||<|0.001|TWO_SIDED|95.0|4.94|7.05|||ANCOVA|||PRID at 4 hour||7.05|4.94|< 0.001
71028763|NCT02863575|141565191|SUPERIORITY||LS means difference|0.31||||0.438|TWO_SIDED|95.0|-0.48|1.11|||ANCOVA|||PRID at 5 hour||1.11|-0.48|0.438
71028764|NCT02863575|141565191|SUPERIORITY||LS means difference|5.47|||<|0.001|TWO_SIDED|95.0|4.33|6.6|||ANCOVA|||PRID at 5 hour||6.60|4.33|< 0.001
71028765|NCT02863575|141565191|SUPERIORITY||LS means difference|5.15|||<|0.001|TWO_SIDED|95.0|4.01|6.29|||ANCOVA|||PRID at 5 hour||6.29|4.01|< 0.001
71028766|NCT02863575|141565191|SUPERIORITY||LS means difference|0.5||||0.25|TWO_SIDED|95.0|-0.35|1.35|||ANCOVA|||PRID at 6 hour||1.35|-0.35|0.250
71028767|NCT02863575|141565191|SUPERIORITY||LS means difference|4.8|||<|0.001|TWO_SIDED|95.0|3.58|6.02|||ANCOVA|||PRID at 6 hour||6.02|3.58|< 0.001
71028768|NCT02863575|141565191|SUPERIORITY||LS means difference|4.3|||<|0.001|TWO_SIDED|95.0|3.08|5.52|||ANCOVA|||PRID at 6 hour||5.52|3.08|< 0.001
71028769|NCT02863575|141565191|SUPERIORITY||LS means difference|0.11||||0.818|TWO_SIDED|95.0|-0.8|1.01|||ANCOVA|||PRID at 7 hour||1.01|-0.80|0.818
71028770|NCT02863575|141565191|SUPERIORITY||LS means difference|3.53|||<|0.001|TWO_SIDED|95.0|2.23|4.82|||ANCOVA|||PRID at 7 hour||4.82|2.23|< 0.001
71028771|NCT02863575|141565191|SUPERIORITY||LS means difference|3.42|||<|0.001|TWO_SIDED|95.0|2.12|4.71|||ANCOVA|||PRID at 7 hour||4.71|2.12|< 0.001
71028772|NCT02863575|141565191|SUPERIORITY||LS means difference|0.18||||0.698|TWO_SIDED|95.0|-0.74|1.11|||ANCOVA|||PRID at 8 hour||1.11|-0.74|0.698
71028773|NCT02863575|141565191|SUPERIORITY||LS means difference|3.02|||<|0.001|TWO_SIDED|95.0|1.69|4.34|||ANCOVA|||PRID at 8 hour||4.34|1.69|< 0.001
71028774|NCT02863575|141565191|SUPERIORITY||LS means difference|2.83|||<|0.001|TWO_SIDED|95.0|1.51|4.16|||ANCOVA|||PRID at 8 hour||4.16|1.51|< 0.001
71028775|NCT02863575|141565192|SUPERIORITY||LS means difference|0.04||||0.575|TWO_SIDED|94.0|-0.09|0.16|||ANCOVA|||PRR score at 0.25 hour||0.16|-0.09|0.575
71028776|NCT02863575|141565192|SUPERIORITY||LS means difference|0.07||||0.426|TWO_SIDED|95.0|-0.11|0.25|||ANCOVA|||PRR score at 0.25 hour||0.25|-0.11|0.426
71028777|NCT02863575|141565192|SUPERIORITY||LS means difference|0.04||||0.686|TWO_SIDED|95.0|-0.14|0.22|||ANCOVA|||PRR score at 0.25 hour||0.22|-0.14|0.686
71028778|NCT02863575|141565192|SUPERIORITY||LS means difference|0.07||||0.543|TWO_SIDED|95.0|-0.15|0.29|||ANCOVA|||PRR score at 0.5 hour||0.29|-0.15|0.543
71028779|NCT02863575|141565192|SUPERIORITY||LS means difference|0.81|||<|0.001|TWO_SIDED|95.0|0.49|1.12|||ANCOVA|||PRR score at 0.5 hour||1.12|0.49|< 0.001
71028780|NCT02863575|141565192|SUPERIORITY||LS means difference|0.74|||<|0.001|TWO_SIDED|95.0|0.42|1.05|||ANCOVA|||PRR score at 0.5 hour||1.05|0.42|< 0.001
71028781|NCT02863575|141565192|SUPERIORITY||LS means difference|0.24||||0.038|TWO_SIDED|95.0|0.01|0.46|||ANCOVA|||PRR score at 1 hour||0.46|0.01|0.038
71028782|NCT02863575|141565192|SUPERIORITY||LS means difference|2.01|||<|0.001|TWO_SIDED|95.0|1.69|2.33|||ANCOVA|||PRR score at 1 hour||2.33|1.69|< 0.001
71028783|NCT02863575|141565192|SUPERIORITY||LS means difference|1.78|||<|0.001|TWO_SIDED|95.0|1.46|2.09|||ANCOVA|||PRR score at 1 hour||2.09|1.46|< 0.001
71028784|NCT02863575|141565192|SUPERIORITY||LS means difference|0.25||||0.024|TWO_SIDED|95.0|0.03|0.47|||ANCOVA|||PRR score at 1.5 hour||0.47|0.03|0.024
71028785|NCT02863575|141565192|SUPERIORITY||LS means difference|2.33|||<|0.001|TWO_SIDED|95.0|2.02|2.64|||ANCOVA|||PRR score at 1.5 hour||2.64|2.02|< 0.001
71028786|NCT02863575|141565192|SUPERIORITY||LS means difference|2.08|||<|0.001|TWO_SIDED|95.0|1.77|2.39|||ANCOVA|||PRR score at 1.5 hour||2.39|1.77|< 0.001
71028787|NCT02863575|141565192|SUPERIORITY||LS means difference|0.18||||0.103|TWO_SIDED|95.0|-0.04|0.4|||ANCOVA|||PRR score at 2 hour||0.40|-0.04|0.103
71028788|NCT02863575|141565192|SUPERIORITY||LS means difference|2.4|||<|0.001|TWO_SIDED|95.0|2.09|2.71|||ANCOVA|||PRR score at 2 hour||2.71|2.09|< 0.001
71028789|NCT02863575|141565192|SUPERIORITY||LS means difference|2.22|||<|0.001|TWO_SIDED|95.0|1.91|2.53|||ANCOVA|||PRR score at 2 hour||2.53|1.91|< 0.001
71113212|NCT00282087|141734057|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.02|||||TWO_SIDED||||||Cox Proportional Hazards|||Menopausal status at diagnosis correlation with progression-free survival for patients on study treatment.||||
71113213|NCT00282087|141734058|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.101|||||TWO_SIDED||||||Cox Proportional Hazards|||Uterine serosal involvement correlation with progression-free survival for patients on study treatment.||||
71113214|NCT00282087|141734059|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|-0.00676|||||TWO_SIDED||||||Cox Proportional Hazards|||Mitotic rate correlation with progression-free survival for patients on study treatment.||||
70941929|NCT03866434|141384008|EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%.|% ratio of Geometric LS means|73.705|||||TWO_SIDED|90.0|64.555|84.152|||ANOVA|A 2-factor analysis of variance (ANOVA) model with fixed factors for treatment and participant was fitted to the natural logtransformed PK parameters.|This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole \[Day 8\] versus anagrelide alone \[Day 1\]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the LS mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CI were calculated.||84.152|64.555|
71028790|NCT02863575|141565192|SUPERIORITY||LS means difference|0.08||||0.448|TWO_SIDED|95.0|-0.13|0.29|||ANCOVA|||PRR score at 3 hour||0.29|-0.13|0.448
71113215|NCT00282087|141734060|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|-0.708|||||TWO_SIDED||||||Cox Proportional Hazards|||Estrogen receptor (ER) status correlation with progression-free survival for patients on study treatment.||||
71113216|NCT00282087|141734061|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|-0.906|||||TWO_SIDED||||||Cox Proportional Hazards|||Progesterone receptor (PR) status correlation with progression-free survival for patients on study treatment.||||
71113217|NCT00282087|141734062|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.207|||||TWO_SIDED||||||Cox Proportional Hazards|||1988 FIGO Stage correlation with progression-free survival for patients on study treatment.||||
71113218|NCT00282087|141734063|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|-0.564|||||TWO_SIDED||||||Cox Proportional Hazards|||Estrogen receptor (ER) or progesterone receptor (PR) positive correlation with progression-free survival for patients on study treatment.||||
71113219|NCT03938103|141734080|OTHER|||||||0.101|||||||Mixed Models Analysis|||||||0.101
71113220|NCT03938103|141734081|OTHER|||||||0.383|||||||Mixed Models Analysis|||||||0.383
71113221|NCT03248531|141734101|OTHER||Mean posterior difference|31.2|STANDARD_DEVIATION|10.1|||TWO_SIDED|95.0|11.0|50.4|||Regression, Logistic|||Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model. 95% credible intervals were presented for the bimekizumab (BKZ) vs placebo (PBO) comparison.||50.4|11.0|
71028791|NCT02863575|141565192|SUPERIORITY||LS means difference|2.16|||<|0.001|TWO_SIDED|95.0|1.86|2.47|||ANCOVA|||PRR score at 3 hour||2.47|1.86|< 0.001
71028792|NCT02863575|141565192|SUPERIORITY||LS means difference|2.08|||<|0.001|TWO_SIDED|95.0|1.78|2.38|||ANCOVA|||PRR score at 3 hour||2.38|1.78|< 0.001
71028793|NCT02863575|141565192|SUPERIORITY||LS means difference|0.0||||0.997|TWO_SIDED|95.0|-0.23|0.23|||ANCOVA|||PRR score at 4 hour||0.23|-0.23|0.997
71028794|NCT02863575|141565192|SUPERIORITY||LS means difference|1.94|||<|0.001|TWO_SIDED|95.0|1.61|2.28|||ANCOVA|||PRR score at 4 hour||2.28|1.61|< 0.001
71028795|NCT02863575|141565192|SUPERIORITY||LS means difference|1.94|||<|0.001|TWO_SIDED|95.0|1.61|2.28|||ANCOVA|||PRR score at 4 hour||2.28|1.61|< 0.001
71028796|NCT02863575|141565192|SUPERIORITY||LS means difference|0.06||||0.656|TWO_SIDED|95.0|-0.19|0.31|||ANCOVA|||PRR score at 5 hour||0.31|-0.19|0.656
71028797|NCT02863575|141565192|SUPERIORITY||LS means difference|1.73|||<|0.001|TWO_SIDED|95.0|1.36|2.09|||ANCOVA|||PRR score at 5 hour||2.09|1.36|< 0.001
71028798|NCT02863575|141565192|SUPERIORITY||LS means difference|1.67|||<|0.001|TWO_SIDED|95.0|1.31|2.03|||ANCOVA|||PRR score at 5 hour||2.03|1.31|< 0.001
71028799|NCT02863575|141565192|SUPERIORITY||LS means difference|0.11||||0.425|TWO_SIDED|94.0|-0.16|0.38|||ANCOVA|||PRR score at 6 hour||0.38|-0.16|0.425
71028800|NCT02863575|141565192|SUPERIORITY||LS means difference|1.51|||<|0.001|TWO_SIDED|95.0|1.12|1.9|||ANCOVA|||PRR score at 6 hour||1.90|1.12|< 0.001
71028801|NCT02863575|141565192|SUPERIORITY||LS means difference|1.4|||<|0.001|TWO_SIDED|95.0|1.01|1.79|||ANCOVA|||PRR score at 6 hour||1.79|1.01|< 0.001
71028802|NCT02863575|141565192|SUPERIORITY||LS means difference|-0.03||||0.841|TWO_SIDED|95.0|-0.32|0.26|||ANCOVA|||PRR score at 7 hour||0.26|-0.32|0.841
71028803|NCT02863575|141565192|SUPERIORITY||LS means difference|1.1|||<|0.001|TWO_SIDED|95.0|0.69|1.52|||ANCOVA|||PRR score at 7 hour||1.52|0.69|< 0.001
71028804|NCT02863575|141565192|SUPERIORITY||LS means difference|1.13|||<|0.001|TWO_SIDED|95.0|0.72|1.55|||ANCOVA|||PRR score at 7 hour||1.55|0.72|< 0.001
71028805|NCT02863575|141565192|SUPERIORITY||LS means difference|0.0||||0.98||95.0|-0.3|0.3|||ANCOVA|||PRR score at 8 hour||0.30|-0.30|0.980
71028806|NCT02863575|141565192|SUPERIORITY||LS means difference|0.93|||<|0.001|TWO_SIDED|95.0|0.5|1.36|||ANCOVA|||PRR score at 8 hour||1.36|0.50|< 0.001
71028807|NCT02863575|141565192|SUPERIORITY||LS means difference|0.93|||<|0.001|TWO_SIDED|95.0|0.5|1.35|||ANCOVA|||PRR score at 8 hour||1.35|0.50|< 0.001
71028808|NCT02863575|141565193|SUPERIORITY||LS means difference|-0.03||||0.808|TWO_SIDED|95.0|-0.27|0.21|||ANCOVA|||PID score at 0.25 hour||0.21|-0.27|0.808
71028809|NCT02863575|141565193|SUPERIORITY||LS means difference|0.04||||0.804|TWO_SIDED|95.0|-0.3|0.39|||ANCOVA|||PID score at 0.25 hour||0.39|-0.30|0.804
71028810|NCT02863575|141565193|SUPERIORITY||LS means difference|0.07||||0.676|TWO_SIDED|95.0|-0.27|0.42|||ANCOVA|||PID score at 0.25 hr||0.42|-0.27|0.676
71028811|NCT02863575|141565193|SUPERIORITY||LS means difference|-0.1||||0.654|TWO_SIDED|95.0|-0.55|0.35|||ANCOVA|||PID score at 0.5 hour||0.35|-0.55|0.654
71028812|NCT02863575|141565193|SUPERIORITY||LS means difference|1.45|||<|0.001|TWO_SIDED|95.0|0.81|2.1|||ANCOVA|||PID score at 0.5 hour||2.10|0.81|< 0.001
71028813|NCT02863575|141565193|SUPERIORITY||LS means difference|1.55|||<|0.001|TWO_SIDED|95.0|0.91|2.2|||ANCOVA|||PID score at 0.5 hour||2.20|0.91|< 0.001
71028814|NCT02863575|141565193|SUPERIORITY||LS means difference|0.49||||0.045|TWO_SIDED|95.0|0.01|0.97|||ANCOVA|||PID score at 1 hour||0.97|0.01|0.045
71028815|NCT02863575|141565193|SUPERIORITY||LS means difference|4.1|||<|0.001||95.0|3.41|4.78|||ANCOVA|||PID score at 1 hour||4.78|3.41|< 0.001
71069375|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|2.388|||||TWO_SIDED|95.0|1.658|3.438||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.438|1.658|
70852799|NCT02744040|141194418|OTHER|Tukey's Honest Significant Difference (HSD) test|||||>|0.05||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in integrated HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for integrated HIV DNA.||||>0.05
71069376|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.987|||||TWO_SIDED|95.0|0.688|1.416||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.416|0.688|
71069377|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.012|||||TWO_SIDED|95.0|0.701|1.46||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.460|0.701|
71079277|NCT01964989|141666168|OTHER||GMT ratio|0.95|||||TWO_SIDED|95.0|0.8|1.1||||||TIV/QIV GMT ratio (High risk/Healthy) for A/H1N1 at D22/50 (Pooled Naïve \& Non-naïve).||1.1|0.8|
71079278|NCT01964989|141666168|OTHER||GMT ratio|0.98|||||TWO_SIDED|95.0|0.8|1.1||||||TIV/QIV GMT ratio (High risk/Healthy) for A/H3N2 at D22/50 (Pooled Naïve \& Non-naïve).||1.1|0.8|
71079279|NCT01964989|141666168|OTHER||GMT ratio|0.95|||||TWO_SIDED|95.0|0.8|1.1||||||TIV/QIV GMT ratio (High risk/Healthy) for B/YAM at D22/50 (Pooled Naïve \& Non-naïve).||1.1|0.8|
71079280|NCT01964989|141666168|OTHER||GMT ratio|0.92|||||TWO_SIDED|95.0|0.7|1.2||||||TIV/QIV GMT ratio (High risk/Healthy) for B/VIC at D22/50 (Pooled Naïve \& Non-naïve).||1.2|0.7|
71028816|NCT02863575|141565193|SUPERIORITY||LS means difference|3.6|||<|0.001|TWO_SIDED|95.0|2.92|4.29|||ANCOVA|||PID score at 1 hour||4.29|2.92|< 0.001
71028817|NCT02863575|141565193|SUPERIORITY||LS means difference|0.59||||0.015|TWO_SIDED|95.0|0.11|1.06|||ANCOVA|||PID score at 1.5 hour||1.06|0.11|0.015
71028818|NCT02863575|141565193|SUPERIORITY||LS means difference|5.03|||<|0.001|TWO_SIDED|95.0|4.35|5.71|||ANOVA|||PID score at 1.5 hour||5.71|4.35|< 0.001
71028819|NCT02863575|141565193|SUPERIORITY||LS means difference|4.44|||<|0.001|TWO_SIDED|95.0|3.76|5.12|||ANCOVA|||PID score at 1.5 hour||5.12|3.76|< 0.001
71028820|NCT02863575|141565193|SUPERIORITY||LS means difference|0.44||||0.066|TWO_SIDED|95.0|-0.03|0.91|||ANCOVA|||PID score at 2 hour||0.91|-0.03|0.066
71028821|NCT02863575|141565193|SUPERIORITY||LS means difference|5.22|||<|0.001|TWO_SIDED|95.0|4.54|5.89|||ANCOVA|||PID score at 2 hour||5.89|4.54|< 0.001
71028822|NCT02863575|141565193|SUPERIORITY||LS means difference|4.78|||<|0.001|TWO_SIDED|95.0|4.1|5.45|||ANCOVA|||PID score at 2 hour||5.45|4.10|< 0.001
71028823|NCT02863575|141565193|SUPERIORITY||LS means difference|0.32||||0.186|TWO_SIDED|95.0|-0.16|0.81|||ANCOVA|||PID score at 3 hour||0.81|-0.16|0.186
71028824|NCT02863575|141565193|SUPERIORITY||LS means difference|4.66|||<|0.001|TWO_SIDED|95.0|3.98|5.35|||ANCOVA|||PID score at 3 hour||5.35|3.98|< 0.001
71028825|NCT02863575|141565193|SUPERIORITY||LS means difference|4.34|||<|0.001|TWO_SIDED|95.0|3.65|5.03|||ANCOVA|||PID score at 3 hour||5.03|3.65|< 0.001
71028826|NCT02863575|141565193|SUPERIORITY||LS means difference|0.08||||0.75|TWO_SIDED|95.0|-0.43|0.6|||ANCOVA|||PID score at 4 hour||0.60|-0.43|0.750
71028827|NCT02863575|141565193|SUPERIORITY||LS means difference|4.14|||<|0.001|TWO_SIDED|95.0|3.4|4.87|||ANCOVA|||PID score at 4 hour||4.87|3.40|< 0.001
71028828|NCT02863575|141565193|SUPERIORITY||LS means difference|4.05|||<|0.001|TWO_SIDED|95.0|3.32|4.79|||ANCOVA|||PID score at 4 hour||4.79|3.32|< 0.001
71028829|NCT02863575|141565193|SUPERIORITY||LS means difference|0.26||||0.361|TWO_SIDED|95.0|-0.3|0.81|||ANCOVA|||PID score at 5 hour||0.81|-0.30|0.361
71028830|NCT02863575|141565193|SUPERIORITY||LS means difference|3.74|||<|0.001|TWO_SIDED|95.0|2.95|4.53|||ANCOVA|||PID score at 5 hour||4.53|2.95|< 0.001
71028831|NCT02863575|141565193|SUPERIORITY||LS means difference|3.48|||<|0.001|TWO_SIDED|95.0|2.69|4.27|||ANCOVA|||PID score at 5 hour||4.27|2.69|< 0.001
71028832|NCT02863575|141565193|SUPERIORITY||LS means difference|0.39||||0.195|TWO_SIDED|95.0|-0.2|0.98|||ANCOVA|||PID score at 6 hour||0.98|-0.20|0.195
71028833|NCT02863575|141565193|SUPERIORITY||LS means difference|3.29|||<|0.001|TWO_SIDED|95.0|2.44|4.13|||ANCOVA|||PID score at 6 hour||4.13|2.44|< 0.001
71028834|NCT02863575|141565193|SUPERIORITY||LS means difference|2.9|||<|0.001|TWO_SIDED|95.0|2.06|3.74|||ANCOVA|||PID score at 6 hour||3.74|2.06|< 0.001
71028835|NCT02863575|141565193|SUPERIORITY||LS means difference|0.14||||0.669|TWO_SIDED|95.0|-0.49|0.76|||ANCOVA|||PID score at 7 hour||0.76|-0.49|0.669
71028836|NCT02863575|141565193|SUPERIORITY||LS means difference|2.42|||<|0.001|TWO_SIDED|95.0|1.53|3.31|||ANCOVA|||PID score at 7 hour||3.31|1.53|< 0.001
71028837|NCT02863575|141565193|SUPERIORITY||LS means difference|2.29|||<|0.001|TWO_SIDED|95.0|1.4|3.18|||ANCOVA|||PID score at 7 hour||3.18|1.40|< 0.001
71113222|NCT03248531|141734101|OTHER||Mean posterior difference|-2.2|STANDARD_DEVIATION|10.6|||TWO_SIDED|60.0|-11.2|6.6|||Regression, Logistic|||Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model. 60% credible intervals were presented for the BKZ vs adalimumab (ADA) comparison.||6.6|-11.2|
71113223|NCT03248531|141734101|OTHER||Pr [Diff>0%] (%)|99.8|||||||||||Regression, Logistic|||Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model.||||
71113224|NCT03248531|141734101|OTHER||Pr[Diff > 0%](%)|42.1|||||||||||Regression, Logistic|||Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model.||||
71113225|NCT04075513|141734143|NON_INFERIORITY|Non-inferiority was based on a relative margin of 10%. Since higher time in range means better outcome, non-inferiority was demonstrated if the lower bound of the two-sided 95% confidence interval (CI) of the difference between Toujeo LS mean and 90% of Tresiba LS mean at Week 12 was \> 0.|Least square mean difference|3.16|STANDARD_ERROR_OF_MEAN|1.163||0.0067|TWO_SIDED|95.0|0.88|5.44||Threshold of significance at \<0.05.|ANCOVA||This estimation parameter corresponds to the difference between Toujeo LS mean and 90% of Tresiba LS mean.|Analysis was performed using ANCOVA model including the fixed categorical effect of treatment groups and randomization stratum of screening HbA1c (\<8.0%, \>=8.0%) and the continuous fixed covariate of Baseline percent time in range value.||5.44|0.88|0.0067
71028838|NCT02863575|141565193|SUPERIORITY||LS means difference|0.18||||0.581|TWO_SIDED|95.0|-0.46|0.82|||ANCOVA|||PID score at 8 hour||0.82|-0.46|0.581
71028839|NCT02863575|141565193|SUPERIORITY||LS means difference|2.09|||<|0.001|TWO_SIDED|95.0|1.18|3.0|||ANCOVA|||PID score at 8 hour||3.00|1.18|< 0.001
71028840|NCT02863575|141565193|SUPERIORITY||LS means difference|1.91|||<|0.001|TWO_SIDED|95.0|1.0|2.82|||ANCOVA|||PID score at 8 hour||2.82|1.00|< 0.001
71028841|NCT02863575|141565194|SUPERIORITY|||||||0.028|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||0.028
71028842|NCT02863575|141565194|SUPERIORITY||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||<0.001
71028843|NCT02863575|141565194|SUPERIORITY||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||<0.001
71028844|NCT02863575|141565195|SUPERIORITY|||||||0.861|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||0.861
71028845|NCT02863575|141565195|SUPERIORITY||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||<0.001
71028846|NCT02863575|141565195|SUPERIORITY||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||<0.001
71028847|NCT02863575|141565196|SUPERIORITY|||||||0.838|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||0.838
71028848|NCT02863575|141565196|SUPERIORITY||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||<0.001
71028849|NCT02863575|141565196|SUPERIORITY||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||<0.001
71028850|NCT02841709|141565256|OTHER||||||<|0.001|||||||Multiple Comparison Procedure-Model|||"Multiple Comparison Procedure-Modeling (MCP-Mod) was used to assess a dose response across placebo and all ACT-541468 doses. The null hypothesis of no dose response was rejected if at least one of the six Multiple Contrasts Tests (MCTs) had a multiplicity adjusted p-value \<0.05. The analysis was performed using the R-package DoseFinding (Bornkamp B, Pinheiro J, Bretz F. Planning and analyzing dose finding experiments. 2016. Available from: cranrprojects.org/web/packages/DoseFinding.)"||||<0.001
71028851|NCT02841709|141565256|OTHER||LS mean difference|-5.4|STANDARD_ERROR_OF_MEAN|4.73||0.258|TWO_SIDED|95.0|-14.7|4.0|||Linear mixed effects model||Parameter Dispersion Type: Standard Error of the LS Mean|||4.0|-14.7|0.258
71028852|NCT02841709|141565256|OTHER||LS mean difference|-18.4|STANDARD_ERROR_OF_MEAN|4.76|<|0.001|TWO_SIDED|95.0|-27.8|-9.0|||Linear mixed effects model||Parameter Dispersion Type: Standard Error of the LS Mean|||-9.0|-27.8|<0.001
71028853|NCT02841709|141565256|OTHER||LS mean difference|-31.5|STANDARD_ERROR_OF_MEAN|4.74|<|0.001|TWO_SIDED|95.0|-40.9|-22.2|||Linear mixed effects model|||||-22.2|-40.9|<0.001
71028854|NCT02841709|141565256|OTHER||LS mean difference|-47.8|STANDARD_ERROR_OF_MEAN|4.74|<|0.001|TWO_SIDED|95.0|-57.2|-38.5|||Linear mixed effects model|||||-38.5|-57.2|<0.001
71028855|NCT00076102|141565265|OTHER|||||||0.0301||||||The reported F statistic and p-value are representative of the difference in the Parent proxy Form and the Child Self-Report Form response for Adaptive Behavior.|ANOVA|||F=5.45 under the null hypothesis||||0.0301
71028856|NCT00076102|141565265|OTHER|||||||0.0186||||||The reported p-value is representative of the difference in the Parent proxy Form and the Child Self-Report Form response for Emotional Functioning.|ANOVA|||F = 6.56 under the null hypothesis||||0.0186
71028857|NCT00076102|141565265|OTHER|||||||0.0032||||||The reported p-value is representative of the difference in the Parent proxy Form and the Child Self-Report Form response for Medical/Physical Status.|ANOVA|||F=11.23 under the null hypothesis||||0.0032
71028858|NCT00076102|141565266|OTHER|||||||0.6263|||||||ANOVA|||F=0.25 under the null hypothesis||||0.6263
71069378|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.634|||||TWO_SIDED|95.0|1.128|2.366||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.366|1.128|
71069379|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.413|||||TWO_SIDED|95.0|0.288|0.592||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.592|0.288|
71079281|NCT01964989|141666170|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% CI on the unadjusted difference of percentages of subjects seroconverted for HI antibody exceeds 0%.|Seroconversion difference|8.2|||||TWO_SIDED|95.0|5.0|11.3||||||Seroconversion difference (aQIV - Comparator \[TIV/QIV\]) for A/H1N1.||11.3|5.0|
71028859|NCT00076102|141565266|OTHER|||||||0.3625|||||||ANOVA|||F= 0.87 under the null hypothesis||||0.3625
71028860|NCT00076102|141565266|OTHER|||||||0.5877|||||||ANOVA|||F=0.31 under the null hypothesis||||0.5877
71028861|NCT00076102|141565266|OTHER|||||||0.2767|||||||ANOVA|||F=1.27 under the null hypothesis||||0.2767
71028862|NCT00076102|141565266|OTHER|||||||0.8466|||||||ANOVA|||F=0.04 under the null hypothesis||||0.8466
71028863|NCT00076102|141565266|OTHER|||||||0.6774|||||||ANOVA|||F=0.18 under the null hypothesis||||0.6774
71028864|NCT01210001|141565271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|97.5|-0.69|-0.27||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in HbA1c was the first step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline and baseline HbA1c.|Difference calculated as empa 10mg minus placebo|||-0.27|-0.69|<0.0001
71028865|NCT01210001|141565271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|97.5|-0.82|-0.4||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in HbA1c was the first step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline and baseline HbA1c.|Difference calculated as empa 25mg minus placebo|||-0.40|-0.82|<0.0001
71028866|NCT01210001|141565272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.48|STANDARD_ERROR_OF_MEAN|3.71|<|0.0001|TWO_SIDED|97.5|-31.81|-15.15||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in FPG was the second step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline, baseline HbA1c and baseline FPG|Difference calculated as empa 10mg minus placebo|||-15.15|-31.81|<0.0001
71028867|NCT01210001|141565272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.46|STANDARD_ERROR_OF_MEAN|3.68|<|0.0001|TWO_SIDED|97.5|-36.73|-20.19||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in FPG was the second step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline, baseline HbA1c and baseline FPG|Difference calculated as empa 25mg minus placebo|||-20.19|-36.73|<0.0001
71028868|NCT01210001|141565273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.95|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|97.5|-2.64|-1.27||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in body weight was the third step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline, baseline HbA1c and baseline weight|Difference calculated as empa 10mg minus placebo|||-1.27|-2.64|<0.0001
71028869|NCT01210001|141565273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|97.5|-2.49|-1.13||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in body weight was the third step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline, baseline HbA1c and baseline weight|Difference calculated as empa 25mg minus placebo|||-1.13|-2.49|<0.0001
71028870|NCT01210001|141565274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|97.5|-0.69|-0.21||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa vs placebo change from baseline in HbA1c for pio+met background only was the fourth step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline and baseline HbA1c.|Difference calculated as empa 10mg minus placebo|||-0.21|-0.69|<0.0001
71028871|NCT01210001|141565274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|97.5|-0.83|-0.36||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa vs placebo change from baseline in HbA1c for pio+met background only was the fourth step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline and baseline HbA1c.|Difference calculated as empa 25mg minus placebo|||-0.36|-0.83|<0.0001
71028872|NCT03900624|141565283|SUPERIORITY|||||||0.632|||||||Wilcoxon (Mann-Whitney)|||||||0.632
71028873|NCT03900624|141565284|SUPERIORITY|||||||0.725|||||||Wilcoxon (Mann-Whitney)|||||||0.725
71069380|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.424|||||TWO_SIDED|95.0|0.294|0.61||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.610|0.294|
71069381|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.684|||||TWO_SIDED|95.0|0.473|0.99||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.990|0.473|
71069382|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.025|||||TWO_SIDED|95.0|0.714|1.473||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.473|0.714|
71069383|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.656|||||TWO_SIDED|95.0|1.15|2.385||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.385|1.150|
71069384|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.615|||||TWO_SIDED|95.0|1.115|2.339||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.339|1.115|
71069385|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.906|||||TWO_SIDED|95.0|1.177|3.087||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.087|1.177|
71069386|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.945|||||TWO_SIDED|95.0|0.583|1.533||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.533|0.583|
71069387|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.763|||||TWO_SIDED|95.0|0.468|1.245||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.245|0.468|
71069388|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.818|||||TWO_SIDED|95.0|1.119|2.956||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.956|1.119|
71079282|NCT01964989|141666170|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% CI on the unadjusted difference of percentages of subjects seroconverted for HI antibody exceeds 0%.|Seroconversion difference|5.2|||||TWO_SIDED|95.0|1.9|8.4||||||Seroconversion difference (aQIV - Comparator \[TIV/QIV\]) for A/H3N2.||8.4|1.9|
71079283|NCT01964989|141666170|SUPERIORITY||Seroconversion difference|21.3|||||TWO_SIDED|95.0|18.1|24.5||||||Seroconversion difference (aQIV - Comparator \[TIV/QIV\]) for B/YAM.||24.5|18.1|
71079284|NCT01964989|141666170|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% CI on the unadjusted difference of percentages of subjects seroconverted for HI antibody exceeds 0%.|Seroconversion difference|13.6|||||TWO_SIDED|95.0|10.0|17.3||||||Seroconversion difference (aQIV - Comparator \[TIV/QIV\]) for B/VIC.||17.3|10.0|
71079285|NCT01964989|141666171|OTHER||Mean Difference (Final Values)|11.5|||||TWO_SIDED|95.0|9.4|13.7||||||Difference in HI titers ≥ 1:40 (aQIV - Comparator \[TIV/QIV\]) for A/H1N1.||13.7|9.4|
71069389|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.917|||||TWO_SIDED|95.0|0.568|1.481||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.481|0.568|
71069390|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.855|||||TWO_SIDED|95.0|0.524|1.396||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.396|0.524|
71069391|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.203|||||TWO_SIDED|95.0|0.745|1.943||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.943|0.745|
71069392|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.496|||||TWO_SIDED|95.0|0.31|0.794||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.794|0.310|
71069393|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.4|||||TWO_SIDED|95.0|0.25|0.641||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.641|0.250|
71069394|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.954|||||TWO_SIDED|95.0|0.596|1.528||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.528|0.596|
71079286|NCT01964989|141666171|OTHER||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|6.1|9.7||||||Difference in HI titers ≥ 1:40 (aQIV - Comparator \[TIV/QIV\]) for A/H3N2.||9.7|6.1|
71079287|NCT01964989|141666171|OTHER||Mean Difference (Final Values)|21.9|||||TWO_SIDED|95.0|18.1|25.6||||||Difference in HI titers ≥ 1:40 (aQIV - Comparator \[TIV/QIV\]) for B/YAM.||25.6|18.1|
71079288|NCT01964989|141666171|OTHER||Mean Difference (Final Values)|20.9|||||TWO_SIDED|95.0|15.9|25.7||||||Difference in HI titers ≥ 1:40 (aQIV - Comparator \[TIV/QIV\]) for B/VIC.||25.7|15.9|
71079289|NCT01964989|141666172|OTHER||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|5.9|9.7||||||Difference in HI titers ≥ 1:110 for A/H1N1 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||9.7|5.9|
71079290|NCT01964989|141666172|OTHER||Mean Difference (Final Values)|9.8|||||TWO_SIDED|95.0|7.8|11.9||||||Difference in HI Titers ≥ 1:151 for A/H1N1 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||11.9|7.8|
71079291|NCT01964989|141666172|OTHER||Mean Difference (Final Values)|16.1|||||TWO_SIDED|95.0|13.5|18.7||||||Difference in HI Titers ≥ 1:215 for A/H1N1 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||18.7|13.5|
71028874|NCT03900624|141565285|SUPERIORITY|||||||0.725|||||||Wilcoxon (Mann-Whitney)|||||||0.725
71028875|NCT00890981|141565303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7||||0.0766||95.0|-0.4|7.8|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear, quadratic and cubic time terms with treatment-by-time interaction||7.8|-0.4|0.0766
71028876|NCT00890981|141565304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.1648||95.0|-0.6|3.5|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||3.5|-0.6|0.1648
71028877|NCT00890981|141565305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.0228||95.0|0.1|1.7|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear, quadratic and cubic time terms but without treatment-by-time interaction.||1.7|0.1|0.0228
71028878|NCT00890981|141565306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.656||95.0|-2.5|4.0|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model includes linear, quadratic and cubic time terms but without treatment-by-time interaction.||4.0|-2.5|0.6560
71069395|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.481|||||TWO_SIDED|95.0|0.306|0.758||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.758|0.306|
71069396|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.449|||||TWO_SIDED|95.0|0.279|0.722||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.722|0.279|
71069397|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.631|||||TWO_SIDED|95.0|0.398|1.002||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.002|0.398|
71069398|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.807|||||TWO_SIDED|95.0|0.5|1.304||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.304|0.500|
71069399|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.924|||||TWO_SIDED|95.0|1.193|3.102||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.102|1.193|
71069400|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.97|||||TWO_SIDED|95.0|0.611|1.541||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.541|0.611|
71069401|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.905|||||TWO_SIDED|95.0|0.561|1.46||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.460|0.561|
71069402|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.273|||||TWO_SIDED|95.0|0.798|2.03||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.030|0.798|
71069403|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|2.383|||||TWO_SIDED|95.0|1.474|3.851||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.851|1.474|
71069404|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.202|||||TWO_SIDED|95.0|0.754|1.915||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.915|0.754|
71079292|NCT01964989|141666172|OTHER||Mean Difference (Final Values)|23.1|||||TWO_SIDED|95.0|19.8|26.4||||||Difference in HI Titers ≥ 1:330 for A/H1N1 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||26.4|19.8|
71079293|NCT01964989|141666172|OTHER||Mean Difference (Final Values)|24.1|||||TWO_SIDED|95.0|20.6|27.6||||||Difference in HI Titers ≥ 1:629 for A/H1N1 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||27.6|20.6|
71069405|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.12|||||TWO_SIDED|95.0|0.689|1.821||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.821|0.689|
71069406|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.576|||||TWO_SIDED|95.0|0.987|2.516||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.516|0.987|
71069407|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.504|||||TWO_SIDED|95.0|0.316|0.805||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.805|0.316|
71069408|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.47|||||TWO_SIDED|95.0|0.293|0.754||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.754|0.293|
71069409|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.662|||||TWO_SIDED|95.0|0.414|1.056||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.056|0.414|
71079294|NCT01964989|141666172|OTHER||Mean Difference (Final Values)|5.9|||||TWO_SIDED|95.0|4.5|7.5||||||Difference in HI Titers ≥ 1:110 for A/H3N2 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||7.5|4.5|
71079295|NCT01964989|141666172|OTHER||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|6.1|9.6||||||Difference in HI Titers ≥ 1:151 for A/H3N2 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||9.6|6.1|
71069410|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.932|||||TWO_SIDED|95.0|0.583|1.492||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.492|0.583|
71069411|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.312|||||TWO_SIDED|95.0|0.831|2.071||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.071|0.831|
71069412|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.407|||||TWO_SIDED|95.0|0.88|2.249||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.249|0.880|
71069413|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|5.428|||||TWO_SIDED|95.0|4.0|7.365||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||7.365|4|
71069414|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|1.091|||||TWO_SIDED|95.0|0.804|1.481||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.481|0.804|
71069415|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.759|||||TWO_SIDED|95.0|0.559|1.031||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.031|0.559|
71069416|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|3.499|||||TWO_SIDED|95.0|2.577|4.751||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||4.751|2.577|
71069417|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.982|||||TWO_SIDED|95.0|0.722|1.334||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.334|0.722|
71079296|NCT01964989|141666172|OTHER||Mean Difference (Final Values)|11.7|||||TWO_SIDED|95.0|9.6|13.9||||||Difference in HI Titers ≥ 1:215 for A/H3N2 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||13.9|9.6|
71079297|NCT01964989|141666172|OTHER||Mean Difference (Final Values)|19.0|||||TWO_SIDED|95.0|16.1|22.0||||||Difference in HI Titers ≥ 1:330 for A/H3N2 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||22.0|16.1|
71079298|NCT01964989|141666172|OTHER||Mean Difference (Final Values)|21.1|||||TWO_SIDED|95.0|17.8|24.3||||||Difference in HI Titers ≥ 1:629 for A/H3N2 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||24.3|17.8|
71079299|NCT01964989|141666172|OTHER||Mean Difference (Final Values)|28.8|||||TWO_SIDED|95.0|25.1|32.3||||||Difference in HI Titers ≥ 1:110 for B/YAM (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||32.3|25.1|
71079300|NCT01964989|141666172|OTHER||Mean Difference (Final Values)|26.3|||||TWO_SIDED|95.0|22.6|29.9||||||Difference in HI Titers ≥ 1:151 for B/YAM (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||29.9|22.6|
71079301|NCT01964989|141666172|OTHER||Mean Difference (Final Values)|21.8|||||TWO_SIDED|95.0|18.3|25.3||||||Difference in HI Titers ≥ 1:215 for B/YAM (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||25.3|18.3|
71079302|NCT01964989|141666172|OTHER||Mean Difference (Final Values)|11.6|||||TWO_SIDED|95.0|8.6|14.5||||||Difference in HI Titers ≥ 1:330 for B/YAM (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||14.5|8.6|
71079303|NCT01964989|141666172|OTHER||Mean Difference (Final Values)|6.8|||||TWO_SIDED|95.0|4.3|9.4||||||Difference in HI Titers ≥ 1:629 for B/YAM (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||9.4|4.3|
71069418|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.699|||||TWO_SIDED|95.0|0.513|0.95||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||0.95|0.513|
71069419|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|2.513|||||TWO_SIDED|95.0|1.846|3.421||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.421|1.846|
71069420|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.201|||||TWO_SIDED|95.0|0.149|0.272||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.272|0.149|
71069421|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.14|||||TWO_SIDED|95.0|0.103|0.189||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.189|0.103|
71079304|NCT00424593|141666182|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||Model included treatment, non-steriodal anti-inflammatory drug (NSAID) use (Yes/No), investigator, visit, treatment-by-visit interaction, baseline pain severity, and baseline-by-visit interaction.|Repeated Measures Analysis|||||||0.004
70852800|NCT02744040|141194418|OTHER|Tukey's Honest Significant Difference (HSD) test|||||>|0.05||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in integrated HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for integrated HIV DNA.||||>0.05
71028879|NCT00890981|141565307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.0594||95.0|-0.1|3.7|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||3.7|-0.1|0.0594
71028880|NCT00890981|141565308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.0032||95.0|0.9|4.3|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||4.3|0.9|0.0032
71028881|NCT00890981|141565309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.2897||95.0|-0.4|1.2|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear, quadratic and cubic time terms but without treatment-by-time interaction.||1.2|-0.4|0.2897
71028882|NCT00890981|141565310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9||||0.0067||95.0|1.1|6.7|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||6.7|1.1|0.0067
71028883|NCT00890981|141565311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1||||0.0184||95.0|0.4|3.8|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||3.8|0.4|0.0184
71028884|NCT00890981|141565312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.0911||95.0|-0.3|3.5|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||3.5|-0.3|0.0911
71028885|NCT00890981|141565313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1||||0.0035||95.0|0.7|3.5|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||3.5|0.7|0.0035
71028886|NCT00890981|141565314|SUPERIORITY_OR_OTHER||Ratio of Denosumab to Placebo|1.1||||0.0591||95.0|1.0|1.3|||ANCOVA|||ANCOVA based on the log transformed actual values with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||1.3|1.0|0.0591
71028887|NCT00890981|141565315|SUPERIORITY_OR_OTHER||Ratio of Denosumab to Placebo|1.2||||0.0079||95.0|1.0|1.3|||ANCOVA|||ANCOVA based on the log transformed actual values with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||1.3|1.0|0.0079
71028888|NCT00977106|141565321|SUPERIORITY_OR_OTHER|||||||0.472|||||||Chi-squared|||||||0.472
71028889|NCT00977106|141565322|SUPERIORITY_OR_OTHER|||||||0.377||||||Between-group test (equal variances)|Student t-test|||Change at Week 1||||0.377
71028890|NCT00977106|141565322|SUPERIORITY_OR_OTHER|||||||0.276|||||||Student t-test|Between-group test (unequal variances)||Change at Week 4||||0.276
71028891|NCT00977106|141565324|SUPERIORITY_OR_OTHER|||||||0.502|||||||Student t-test|Between-group test (equal variances)||Change at Week 4||||0.502
71028892|NCT00977106|141565326|SUPERIORITY_OR_OTHER|||||||0.434||||||Between placebo and TCZ groups test (Equal Variances) at week 4|t-test, 1 sided|||||||0.434
71028893|NCT00977106|141565328|SUPERIORITY_OR_OTHER|||||||0.692|||||||Wilcoxon (Mann-Whitney)|||Change at Week 1||||0.692
71028894|NCT00977106|141565328|SUPERIORITY_OR_OTHER|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||Change at Week 4||||0.019
71028895|NCT00977106|141565329|SUPERIORITY_OR_OTHER|||||||0.137|||||||Wilcoxon (Mann-Whitney)|||Change at Week 1||||0.137
71028896|NCT00977106|141565329|SUPERIORITY_OR_OTHER|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||Change at Week 4||||0.043
71028897|NCT02319148|141565383|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|105.28|||||TWO_SIDED|90.0|92.11|120.34|||Mixed Models Analysis|||||120.34|92.11|
71028898|NCT02319148|141565383|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|92.54|||||TWO_SIDED|90.0|80.96|105.77|||Mixed Models Analysis|||||105.77|80.96|
71028899|NCT02319148|141565383|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|116.36|||||TWO_SIDED|90.0|101.86|132.92|||Mixed Models Analysis|||||132.92|101.86|
71028900|NCT02319148|141565384|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|90.16|||||TWO_SIDED|90.0|78.57|103.46|||Mixed Models Analysis|||||103.46|78.57|
71028901|NCT02319148|141565384|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|106.38|||||TWO_SIDED|90.0|92.7|122.07|||Mixed Models Analysis|||||122.07|92.70|
71028902|NCT02319148|141565384|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|101.71|||||TWO_SIDED|90.0|88.68|116.66|||Mixed Models Analysis|||||116.66|88.68|
71028903|NCT02319148|141565385|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|91.33|||||TWO_SIDED|90.0|79.49|104.94|||Mixed Models Analysis|||||104.94|79.49|
71113226|NCT04075513|141734144|NON_INFERIORITY|Non-inferiority was based on a relative margin of 10%. Since lower CV means better outcome, non-inferiority was demonstrated if the upper bound of the two-sided 95% CI of the difference between Toujeo LS mean and 110% of Tresiba LS mean at Week 12 was \< 0.|Least square mean difference|-5.44|STANDARD_ERROR_OF_MEAN|0.542|<|0.0001|TWO_SIDED|95.0|-6.5|-4.38||Threshold of significance at \<0.05.|ANCOVA||This estimation parameter corresponds to the difference between Toujeo LS mean and 110% of Tresiba LS mean.|A hierarchical step-down testing procedure was used to control type I error. The hierarchical testing was then performed sequentially only when the primary endpoint demonstrated non-inferiority. Analysis was performed using ANCOVA model including the fixed categorical effect of treatment groups and randomization stratum of screening HbA1c (\<8.0%, \>=8.0%) and the continuous fixed covariate of Baseline percent time in range value.||-4.38|-6.50|<0.0001
71113227|NCT04075513|141734145|SUPERIORITY|Superiority was demonstrated if the lower bound of the two-sided 95% CI of the adjusted difference estimate of Toujeo and Tresiba at Week 12 was \>0.|Least square mean difference|-2.35|STANDARD_ERROR_OF_MEAN|1.225||0.0548|TWO_SIDED|95.0|-4.75|0.05||Threshold of significance at \<0.05.|ANCOVA|||A hierarchical step-down testing procedure was used to control type I error. The hierarchical testing was then performed sequentially when the primary endpoint and the secondary endpoint of total CV demonstrated non-inferiority. Analysis was performed using ANCOVA model including the fixed categorical effect of treatment groups and randomization stratum of screening HbA1c (\<8.0%, \>=8.0%) and the continuous fixed covariate of Baseline percent time in range value.||0.05|-4.75|0.0548
71113228|NCT01407952|141734167|SUPERIORITY||Odds Ratio (OR)|2.32||||0.002|TWO_SIDED|95.0|1.36|3.97|||Regression, Logistic|||A intent to treat analysis was performed, using multiple imputation methods.||3.97|1.36|0.002
71113229|NCT01407952|141734167|SUPERIORITY||Odds Ratio (OR)|3.97|||<|0.01|TWO_SIDED|95.0|1.99|7.92||Chi-squared test statistic with one degree of freedom=17.37|Chi-squared|||||7.92|1.99|<0.01
71113230|NCT01407952|141734168|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71113231|NCT01407952|141734169|SUPERIORITY|||||||0.578|||||||Wilcoxon (Mann-Whitney)|||||||0.578
71113232|NCT01407952|141734170|SUPERIORITY|||||||0.352|||||||Chi-squared|Chi-squared test statistic with one degree of freedom = 0.865||||||0.352
71113233|NCT01407952|141734171|SUPERIORITY|||||||0.769|||||||Cochran-Armitage Trend Test|||||||0.769
71113234|NCT01407952|141734172|SUPERIORITY|||||||0.641|||||||Chi-squared|Chi-square test statistic with one degree of freedom=0.217||||||0.641
71113235|NCT01407952|141734173|SUPERIORITY|||||||0.003|||||||Chi-squared|chi-square test statistic with one degree of freedom=8.82||||||0.003
71113236|NCT01407952|141734174|SUPERIORITY|||||||0.162|||||||Chi-squared|Chi-squared test statistic with one degree of freedom=1.955||||||0.162
71113237|NCT01407952|141734175|SUPERIORITY|||||||0.245|||||||Fisher Exact|||||||0.245
71028904|NCT02319148|141565385|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|106.97|||||TWO_SIDED|90.0|93.1|122.91|||Mixed Models Analysis|||||122.91|93.10|
71028905|NCT02319148|141565385|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|102.69|||||TWO_SIDED|90.0|89.42|117.93|||Mixed Models Analysis|||||117.93|89.42|
71028906|NCT04084483|141565457|SUPERIORITY|||||||0.2175|||||||ANCOVA|||||||0.2175
71028907|NCT04084483|141565458|SUPERIORITY|||||||0.3852|||||||ANCOVA|||||||0.3852
71028908|NCT04084483|141565459|SUPERIORITY|||||||0.298|||||||ANCOVA|||||||0.2980
71028909|NCT04084483|141565460|SUPERIORITY|||||||0.0634|||||||ANCOVA|||||||0.0634
71028910|NCT04084483|141565461|SUPERIORITY|||||||0.7388|||||||ANCOVA|||Corneal Sum||||0.7388
71028911|NCT04084483|141565461|SUPERIORITY|||||||0.3717|||||||ANCOVA|||Corneal Sum||||0.3717
71028912|NCT04084483|141565461|SUPERIORITY|||||||0.3164|||||||ANCOVA|||Conjunctival Sum||||0.3164
71028913|NCT04084483|141565461|SUPERIORITY|||||||0.1953|||||||ANCOVA|||Conjunctival Sum||||0.1953
71028914|NCT04084483|141565461|SUPERIORITY|||||||0.4645|||||||ANCOVA|||Total Eye Sum||||0.4645
71028915|NCT04084483|141565461|SUPERIORITY|||||||0.2135|||||||ANCOVA|||Total Eye Sum||||0.2135
71028916|NCT04084483|141565462|SUPERIORITY|||||||0.599|||||||ANCOVA|||||||0.5990
71028917|NCT04084483|141565462|SUPERIORITY|||||||0.2122|||||||ANCOVA|||||||0.2122
71028918|NCT04084483|141565463|SUPERIORITY|||||||0.9146|||||||ANCOVA|||||||0.9146
71028919|NCT04084483|141565463|SUPERIORITY|||||||0.8494|||||||ANCOVA|||||||0.8494
71028920|NCT04084483|141565464|SUPERIORITY|||||||0.4747|||||||ANCOVA|||||||0.4747
71028921|NCT04084483|141565464|SUPERIORITY|||||||0.5619|||||||ANCOVA|||||||0.5619
71028922|NCT04084483|141565465|SUPERIORITY|||||||0.5985|||||||ANCOVA|||||||0.5985
71028923|NCT04084483|141565465|SUPERIORITY|||||||0.7626|||||||ANCOVA|||||||0.7626
71028924|NCT04084483|141565466|SUPERIORITY|||||||0.833|||||||ANCOVA|||||||0.8330
71028925|NCT04084483|141565466|SUPERIORITY|||||||0.2777|||||||ANCOVA|||||||0.2777
71028926|NCT04084483|141565467|SUPERIORITY|||||||0.9829|||||||ANCOVA|||||||0.9829
71028927|NCT04084483|141565467|SUPERIORITY|||||||0.8675|||||||ANCOVA|||||||0.8675
71028928|NCT04084483|141565468|SUPERIORITY|||||||0.5836|||||||ANCOVA|||||||0.5836
71028929|NCT04084483|141565468|SUPERIORITY|||||||0.2352|||||||ANCOVA|||||||0.2352
71028930|NCT04084483|141565469|SUPERIORITY|||||||0.7367|||||||ANCOVA|||Ocular Discomfort||||0.7367
71028931|NCT04084483|141565469|SUPERIORITY|||||||0.3865|||||||ANCOVA|||Ocular Discomfort||||0.3865
71028932|NCT04084483|141565469|SUPERIORITY|||||||0.8796|||||||ANCOVA|||Burning||||0.8796
71028933|NCT04084483|141565469|SUPERIORITY|||||||0.3515|||||||ANCOVA|||Burning||||0.3515
71028934|NCT04084483|141565469|SUPERIORITY|||||||0.6338|||||||ANCOVA|||Dryness||||0.6338
71028935|NCT04084483|141565469|SUPERIORITY|||||||0.4685|||||||ANCOVA|||Dryness||||0.4685
71028936|NCT04084483|141565469|SUPERIORITY|||||||0.4757|||||||ANCOVA|||Grittiness||||0.4757
71028937|NCT04084483|141565469|SUPERIORITY|||||||0.8803|||||||ANCOVA|||Grittiness||||0.8803
71028938|NCT04084483|141565469|SUPERIORITY|||||||0.8529|||||||ANCOVA|||Stinging||||0.8529
71028939|NCT04084483|141565469|SUPERIORITY|||||||0.7713|||||||ANCOVA|||Stinging||||0.7713
71028940|NCT04084483|141565470|SUPERIORITY|||||||0.138|||||||ANCOVA|||Burning/Stinging||||0.1380
71028941|NCT04084483|141565470|SUPERIORITY|||||||0.3334|||||||ANCOVA|||Burning/Stinging||||0.3334
71028942|NCT04084483|141565470|SUPERIORITY|||||||0.1008|||||||ANCOVA|||Itching||||0.1008
71028943|NCT04084483|141565470|SUPERIORITY|||||||0.4582|||||||ANCOVA|||Itching||||0.4582
71079305|NCT00424593|141666183|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||ANCOVA|||||||0.014
71079306|NCT00424593|141666184|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value is for 13 Week Change from Baseline.|ANCOVA|||||||0.009
71079307|NCT00424593|141666185|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Average Pain Score Change from Baseline.|ANCOVA|||||||0.002
71079308|NCT00424593|141666185|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||P-value for Worst Pain Score Change from Baseline.|ANCOVA|||||||0.014
71028944|NCT04084483|141565470|SUPERIORITY|||||||0.1511|||||||ANCOVA|||Foreign Body Sensation||||0.1511
71028945|NCT04084483|141565470|SUPERIORITY|||||||0.2555|||||||ANCOVA|||Foreign Body Sensation||||0.2555
71028946|NCT04084483|141565470|SUPERIORITY|||||||0.1546|||||||ANCOVA|||Blurry Vision||||0.1546
71028947|NCT04084483|141565470|SUPERIORITY|||||||0.0495|||||||ANCOVA|||Blurry Vision||||0.0495
71028948|NCT04084483|141565470|SUPERIORITY|||||||0.5791|||||||ANCOVA|||Eye Dryness||||0.5791
71028949|NCT04084483|141565470|SUPERIORITY|||||||0.0736|||||||ANCOVA|||Eye Dryness||||0.0736
71028950|NCT04084483|141565470|SUPERIORITY|||||||0.3666|||||||ANCOVA|||Photophobia||||0.3666
71028951|NCT04084483|141565470|SUPERIORITY|||||||0.039|||||||ANCOVA|||Photophobia||||0.0390
71028952|NCT04084483|141565470|SUPERIORITY|||||||0.0655|||||||ANCOVA|||Pain||||0.0655
71028953|NCT04084483|141565470|SUPERIORITY|||||||0.1947|||||||ANCOVA|||Pain||||0.1947
71028954|NCT04084483|141565471|SUPERIORITY|||||||0.9274|||||||ANCOVA|||||||0.9274
71028955|NCT04084483|141565471|SUPERIORITY|||||||0.0888|||||||ANCOVA|||||||0.0888
71028956|NCT02194998|141565472|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.|||||<|0.01||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort A's SVR12 rate \<= 70%.||||<0.01
71028957|NCT02194998|141565472|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.||||||0.47||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort B's SVR12 rate \<= 70%.||||0.47
71028958|NCT02194998|141565472|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.|||||<|0.01||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort C's SVR12 rate \<= 70%.||||<0.01
71028959|NCT02194998|141565472|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.||||||0.24||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort D's SVR12 rate \<= 70%.||||0.24
71028960|NCT02194998|141565485|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.|||||<|0.01||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort A's SVR24 rate \<= 70%.||||<0.01
71028961|NCT02194998|141565485|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.||||||0.47||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort B's SVR24 rate \<= 70%.||||0.47
71028962|NCT02194998|141565485|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.|||||<|0.01||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort C's SVR24 rate \<= 70%.||||<0.01
71028963|NCT02194998|141565485|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.||||||0.24||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort D's SVR24 rate \<= 70%.||||0.24
71028964|NCT01458405|141565495|SUPERIORITY|||||||0.6453||||||Repeated measures multivariable linear regression with Baseline as a covariate and unstructured covariance.|Regression, Linear|||||||0.6453
71028965|NCT01890915|141565577|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANOVA|||"Due to impaired thermoregulatory mechanisms secondary to spinal cord injury, subjects with tetraplegia were hypothesized to have a significant rise in core temperature after exposure to warm ambient temperatures, while control subjects were hypothesized to maintain constant core temperature.~Percent change in core temperature of subjects in each group were compared to determine if they were significantly different from baseline to warm exposure."||||0.0001
71028966|NCT01890915|141565578|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||ANOVA|||We hypothesized that subjects with tetraplegia would demonstrate a change in cognitive performance after heat exposure if they had demonstrated a significant increase in core body temperature - as was hypothesized in our primary hypothesis. Cognitive performance was measured, in part, by Interference T-scores derived from the Stroop Color and Word Test.||||0.006
71028967|NCT01890915|141565579|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||ANOVA|||Due to impaired thermoregulatory mechanisms, subjects with tetraplegia were hypothesized to have diminished increases in sweat rate in comparison to controls after heat exposure.||||0.015
71028968|NCT00982553|141565587|SUPERIORITY||Geometric mean ratios|0.79|||||TWO_SIDED|95.0|0.62|1.0||||||||1.00|0.62|
71028969|NCT00982553|141565588|SUPERIORITY||Geometric mean ratios|1.16|||||TWO_SIDED|95.0|0.73|1.86||||||||1.86|0.73|
71028970|NCT00982553|141565589|SUPERIORITY||Geometric mean ratios|1.01|||||TWO_SIDED|95.0|0.87|1.18||||||||1.18|0.87|
71028971|NCT00982553|141565590|SUPERIORITY||Geometric mean ratios|0.82|||||TWO_SIDED|95.0|0.36|1.85||||||||1.85|0.36|
71028972|NCT00860405|141565597|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a coefficient of variation of 0.363 and a desired power of 90 % with a type I level of 2.5 %, N=11 patients per treatment group were needed. The power was calculated by means of the software SAS, version 9.1.3, PROC POWER. Nevertheless, more patients were required for the assessment of safety, therefore 2 × 30 patients were planned to be included in this study.|Ratio of LS-means|0.98|||||TWO_SIDED|95.0|0.84|1.16||Null hypothesis tested by calculating a 2-sided 95% CI for ratio of LS-means μVoluven/μHSA based on ANOVA incl.treatment+centre as effects. If 95% CI was within equivalence range(0.55, 1.82), significant equivalence was concluded (Type I error: 2.5%)|ANOVA|Primary endpoint specified + analysed for PP and ITT population. Confirmatory analysis based on PP population only, no adjustment for multiplicity.|Considered ratio: μVoluven/μHSA = LS-mean of Voluven®/LS-mean of HSA 5%|The aim of the study was to prove equivalence, i.e. H0: μVoluven/μHSA ≤ 0.55 or μVoluven/μHSA ≥ 1.82 H1: 0.55 \< μVoluven/μHSA \< 1.82 where μVoluven was the mean infused volume of Voluven® and μHSA was the mean infused volume of HSA 5%.||1.16|0.84|
71028973|NCT02465567|141565606|SUPERIORITY||Rate Ratio|0.76|||<|0.0001|TWO_SIDED|95.0|0.69|0.83|||Negative Binomial Regression|||||0.83|0.69|<0.0001
71069422|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.645|||||TWO_SIDED|95.0|0.476|0.873||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.873|0.476|
71069423|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.181|||||TWO_SIDED|95.0|0.134|0.245||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||0.245|0.134|
71069424|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.129|||||TWO_SIDED|95.0|0.095|0.174||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.174|0.095|
71069425|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67|Geometric Mean Ratio at day 29|0.463|||||TWO_SIDED|95.0|0.341|0.628||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||0.628|0.341|
71069426|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.696|||||TWO_SIDED|95.0|0.514|0.943||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||0.943|0.514|
71069427|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|3.207|||||TWO_SIDED|95.0|2.368|4.343||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||4.343|2.368|
71069428|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.9|||||TWO_SIDED|95.0|0.665|1.218||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.218|0.665|
71069429|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.64|||||TWO_SIDED|95.0|0.472|0.868||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.868|0.472|
71069430|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|2.303|||||TWO_SIDED|95.0|1.7|3.121||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.121|1.7|
71069431|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|4.608|||||TWO_SIDED|95.0|3.398|6.249||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||6.249|3.398|
71079309|NCT00424593|141666185|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value for Night Pain Score Change from Baseline.|ANCOVA|||||||0.007
71079310|NCT00424593|141666186|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for Worst Pain Score Week 13 Change from Baseline.|ANCOVA|||||||0.011
71079311|NCT00424593|141666186|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Least Pain Score Week 13 Change from Baseline.|ANCOVA|||||||0.001
71079312|NCT00424593|141666186|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-value for Average Pain Score Week 13 Change from Baseline.|ANCOVA|||||||0.019
70852801|NCT02744040|141194418|OTHER|Tukey's Honest Significant Difference (HSD) test|||||>|0.05||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in integrated HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for integrated HIV DNA.||||>0.05
71028974|NCT02465567|141565606|SUPERIORITY||Rate Ratio|0.87||||0.0027|TWO_SIDED|95.0|0.79|0.95|||Negative Binomial Regression|||||0.95|0.79|0.0027
71028975|NCT02465567|141565606|SUPERIORITY||Rate Ratio|0.75|||<|0.0001|TWO_SIDED|95.0|0.69|0.83|||Negative Binomial Regression|||||0.83|0.69|<0.0001
71028976|NCT02465567|141565606|SUPERIORITY||Rate Ratio|0.86||||0.002|TWO_SIDED|95.0|0.79|0.95|||Negative Binomial Regression|||||0.95|0.79|0.0020
71028977|NCT02465567|141565607|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.0035|TWO_SIDED|95.0|0.807|0.959|||Regression, Cox|||||0.959|0.807|0.0035
71028978|NCT02465567|141565607|SUPERIORITY||Hazard Ratio (HR)|0.887||||0.057|TWO_SIDED|95.0|0.814|0.966|||Regression, Cox|||||0.966|0.814|0.057
71028979|NCT02465567|141565607|SUPERIORITY||Hazard Ratio (HR)|0.866||||0.0011|TWO_SIDED|95.0|0.794|0.944|||Regression, Cox|||||0.944|0.794|0.0011
71028980|NCT02465567|141565607|SUPERIORITY||Hazard Ratio (HR)|0.873||||0.0019|TWO_SIDED|95.0|0.801|0.951|||Regression, Cox|||||0.951|0.801|0.0019
71028981|NCT02465567|141565608|SUPERIORITY||Mean Difference (Final Values)|-0.51|||<|0.0001|TWO_SIDED|95.0|-0.68|-0.34|||Linear Repeated Measures|||||-0.34|-0.68|<0.0001
71028982|NCT02465567|141565608|SUPERIORITY||Mean Difference (Final Values)|-0.37|||<|0.0001|TWO_SIDED|95.0|-0.54|-0.2|||Linear Repeated Measures|||||-0.20|-0.54|<0.0001
71028983|NCT02465567|141565608|SUPERIORITY||Mean Difference (Final Values)|-0.35|||<|0.0001|TWO_SIDED|95.0|-0.53|-0.18|||Linear Repeated Measures|||||-0.18|-0.53|<0.0001
71028984|NCT02465567|141565608|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.0127|TWO_SIDED|95.0|-0.39|-0.05|||Linear Repeated Measures|||||-0.05|-0.39|0.0127
71028985|NCT02465567|141565609|SUPERIORITY||Odds Ratio (OR)|1.358|||<|0.0001|TWO_SIDED|95.0|1.199|1.539|||Regression, Logistic|||||1.539|1.199|<0.0001
71028986|NCT02465567|141565609|SUPERIORITY||Odds Ratio (OR)|1.246||||0.0005|TWO_SIDED|95.0|1.1|1.41|||Regression, Logistic|||||1.410|1.100|0.0005
71028987|NCT02465567|141565609|SUPERIORITY||Odds Ratio (OR)|1.283|||<|0.0004|TWO_SIDED|95.0|1.133|1.454|||Regression, Logistic|||||1.454|1.133|<0.0004
71028988|NCT02465567|141565609|SUPERIORITY||Odds Ratio (OR)|1.177||||0.0103|TWO_SIDED|95.0|1.039|1.333|||Regression, Logistic|||||1.333|1.039|0.0103
71028989|NCT02465567|141565610|SUPERIORITY||Hazard Ratio (HR)|0.544||||0.0111|TWO_SIDED|95.0|0.34|0.87|||Regression, Cox|||||0.870|0.340|0.0111
71028990|NCT02465567|141565610|SUPERIORITY||Hazard Ratio (HR)|0.782||||0.3401|TWO_SIDED|95.0|0.472|1.296|||Regression, Cox|||||1.296|0.472|0.3401
71028991|NCT02465567|141565610|SUPERIORITY||Hazard Ratio (HR)|0.789||||0.269|TWO_SIDED|95.0|0.518|1.201|||Regression, Cox|||||1.201|0.518|0.2690
71028992|NCT02465567|141565610|SUPERIORITY||Hazard Ratio (HR)|1.134||||0.5918|TWO_SIDED|95.0|0.716|1.796|||Regression, Cox|||||1.796|0.716|0.5918
71028993|NCT02465567|141565611|SUPERIORITY||Rate Ratio|0.84||||0.6552|TWO_SIDED|95.0|0.69|1.03|||Negative Binomial Regression|||||1.03|0.69|0.6552
71028994|NCT02465567|141565611|SUPERIORITY||Rate Ratio|0.8||||0.0221|TWO_SIDED|95.0|0.66|0.97|||Negative Binomial Regression|||||0.97|0.66|0.0221
71028995|NCT02465567|141565611|SUPERIORITY||Rate Ratio|0.88||||0.2157|TWO_SIDED|95.0|0.72|1.08|||Negative Binomial Regression|||||1.08|0.72|0.2157
71028996|NCT02465567|141565611|SUPERIORITY||Rate Ratio|0.83||||0.0647|TWO_SIDED|95.0|0.69|1.01|||Negative Binomial Regression|||||1.01|0.69|0.0647
71028997|NCT00497796|141565621|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on the ICH guidance, the hypothesis of non-inferiority can be tested using a one-sided 97.5% confidence interval's (CI) upper bound comparing with the non-inferiority margin of 5% (0.05).|Rate difference|0.041|||||TWO_SIDED|95.0|-0.038|0.119|||||Rate difference is the rate of maribavir minus the rate of ganciclovir|||0.119|-0.038|
71028998|NCT00497796|141565621|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.586||||0.2754|TWO_SIDED|95.0|0.682|3.69||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel|||||3.690|0.682|0.2754
71028999|NCT00497796|141565622|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.793||||0.0283|TWO_SIDED|95.0|1.065|3.02||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of the pp65 antigenemia assay||3.020|1.065|0.0283
71029000|NCT00497796|141565622|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.284||||0.0024|TWO_SIDED|95.0|1.338|3.9|||Cochran-Mantel-Haenszel|The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of CMV DNA PCR assay||3.900|1.338|0.0024
71029001|NCT00497796|141565622|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.177||||0.0053|TWO_SIDED|95.0|1.259|3.767||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of pp65 antigenemia or CMV DNA PCR assay||3.767|1.259|0.0053
71029002|NCT00497796|141565622|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.388||||0.2339|TWO_SIDED|95.0|0.811|2.377||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of initiation of anti-CMV therapy||2.377|0.811|0.2339
71029003|NCT00497796|141565623|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Hazard Ratio|2.25|||<|0.0001|TWO_SIDED|95.0|1.62|3.14|||Log Rank||Maribavir versus ganciclovir; Cox's proportional hazards regression model: time = receipt of induction ALA and geographic region (US or Europe) + treatment.|Analysis of time to onset||3.14|1.62|<0.0001
71029004|NCT00497796|141565624|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008|TWO_SIDED|||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel|||Analysis of 100 days post-transplant||||0.0008
71069432|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|1.293|||||TWO_SIDED|95.0|0.954|1.753||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.753|0.954|
71069433|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.92|||||TWO_SIDED|95.0|0.677|1.249||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.249|0.677|
71069434|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|3.31|||||TWO_SIDED|95.0|2.436|4.496||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||4.496|2.436|
71069435|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.281|||||TWO_SIDED|95.0|0.207|0.38||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.38|0.207|
71069436|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.2|||||TWO_SIDED|95.0|0.147|0.271||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.271|0.147|
71069437|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.718|||||TWO_SIDED|95.0|0.529|0.975||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.975|0.529|
71069438|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.712|||||TWO_SIDED|95.0|0.524|0.966||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.966|0.524|
71069439|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|2.56|||||TWO_SIDED|95.0|1.886|3.474||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.474|1.886|
71079313|NCT00424593|141666186|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Pain Right Now Score Week 13 Change from Baseline.|ANCOVA|||||||0.002
71079314|NCT00424593|141666186|SUPERIORITY_OR_OTHER|||||||0.068||95.0||||P-value for General Activity Week 13 Change from Baseline.|ANCOVA|||||||0.068
71079315|NCT00424593|141666186|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for Mood Week 13 Change from Baseline.|ANCOVA|||||||0.009
71079316|NCT00424593|141666186|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value for Walking Ability Week 13 Change from Baseline.|ANCOVA|||||||0.006
71079317|NCT00424593|141666186|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||P-value for Normal Work Week 13 Change from Baseline.|ANCOVA|||||||0.024
71113238|NCT01407952|141734176|SUPERIORITY||||||<|0.01|||||||Chi-squared|Chi-squared test statistic with one degree of freedom=14.743||||||<0.01
71079318|NCT00424593|141666186|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Relations With People Week 13 Change from Baseline.|ANCOVA|||||||0.005
71079319|NCT00424593|141666186|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-value for Sleep Week 13 Change from Baseline.|ANCOVA|||||||0.051
71079320|NCT00424593|141666186|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Enjoyment of Life Week 13 Change from Baseline.|ANCOVA|||||||0.013
71079321|NCT00424593|141666186|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Average Interference Week 13 Change from Baseline.|ANCOVA|||||||0.005
71079322|NCT00424593|141666187|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||P-value for Week 13 Change from Baseline.|ANCOVA|||||||0.092
71079323|NCT00424593|141666188|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Fisher Exact|||||||0.060
71079324|NCT00424593|141666189|SUPERIORITY_OR_OTHER|||||||0.087||95.0|||||Fisher Exact|||||||0.087
71029005|NCT00497796|141565624|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3742|TWO_SIDED|||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel|||Analysis of 6 months post-transplant||||0.3742
71029006|NCT00497796|141565625|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007|TWO_SIDED|||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel|||||||0.0007
71029007|NCT00497796|141565626|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.041|||<|0.0001|TWO_SIDED|95.0|2.179|7.494||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of pp65 antigenemia assay||7.494|2.179|<0.0001
71029008|NCT00497796|141565626|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.448|||<|0.0001|TWO_SIDED|95.0|3.404|12.213||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of CMV DNA PCR assay||12.213|3.404|<0.0001
71029009|NCT00497796|141565626|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.02|||<|0.0001|TWO_SIDED|95.0|3.342|10.843||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of pp65 antigenemia or CMV DNA PCR assay||10.843|3.342|<0.0001
71029010|NCT00497796|141565626|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|11.165|||<|0.0001|TWO_SIDED|95.0|4.146|30.069||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of initiation of anti-CMV therapy||30.069|4.146|<0.0001
71029011|NCT01807637|141565634|SUPERIORITY||Mean Difference (Final Values)|9.1|STANDARD_ERROR_OF_MEAN|5.37||0.05|TWO_SIDED||||||Mixed Models Analysis|||||||.05
71029012|NCT01807637|141565635|SUPERIORITY||Mean Difference (Final Values)|-2.05|STANDARD_DEVIATION|1.12||0.05|TWO_SIDED||||||ANOVA|||||||.05
71029013|NCT01807637|141565636|SUPERIORITY||Mean Difference (Final Values)|15.67|STANDARD_DEVIATION|3.41||0.05|TWO_SIDED||||||ANOVA|||||||.05
71029014|NCT04276883|141565637|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71029015|NCT04276883|141565637|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71029016|NCT04276883|141565638|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 120 minutes post-dose||||<0.0001
71029017|NCT04276883|141565638|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 120 minutes post-dose||||<0.0001
71029018|NCT04276883|141565638|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 90 minutes post-dose||||<0.0001
71029019|NCT04276883|141565638|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 90 minutes post-dose||||<0.0001
71029020|NCT04276883|141565638|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 60 minutes post-dose||||<0.0001
71029021|NCT04276883|141565638|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 60 minutes post-dose||||<0.0001
71029022|NCT04276883|141565638|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 45 minutes post-dose||||<0.0001
71029023|NCT04276883|141565638|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 45 minutes post-dose||||<0.0001
71029024|NCT04276883|141565638|SUPERIORITY|||||||0.0006|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 30 minutes post-dose||||0.0006
71029025|NCT04276883|141565638|SUPERIORITY|||||||0.0028|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 30 minutes post-dose||||0.0028
71029026|NCT04276883|141565638|SUPERIORITY|||||||0.007|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 20 minutes post-dose||||0.0070
71029027|NCT04276883|141565638|SUPERIORITY|||||||0.0092|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 20 minutes post-dose||||0.0092
71029028|NCT00765648|141565656|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-9.3||||0.04|TWO_SIDED|95.0|-18.0|-0.6|||Chi-squared|||||-0.6|-18.0|0.04
71029029|NCT00765648|141565657|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.001
71029030|NCT00765648|141565658|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.76
71029031|NCT00765648|141565659|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED|95.0|||||Chi-squared|||||||0.38
71029032|NCT00765648|141565660|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED|95.0|||||Chi-squared|||||||0.18
71029033|NCT00765648|141565661|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.11
71029034|NCT01062256|141565694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.216|TWO_SIDED|95.0|0.64|1.1||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 4-hour postdose period.||1.10|0.64|0.216
71029035|NCT01062256|141565694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.513|TWO_SIDED|95.0|0.72|1.18||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 4-hour postdose period.||1.18|0.72|0.513
71029036|NCT01062256|141565694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.459|TWO_SIDED|95.0|0.87|1.38||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 4-hour postdose period.||1.38|0.87|0.459
71029037|NCT01062256|141565695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.195|TWO_SIDED|95.0|0.65|1.09||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 2-hour postdose period.||1.09|0.65|0.195
71113239|NCT01407952|141734177|SUPERIORITY||||||<|0.01|||||||Chi-squared|||||||<0.01
71113240|NCT00935493|141734178|SUPERIORITY_OR_OTHER|||||||0.06|||||||Regression, Linear|||||||0.06
71113241|NCT00935493|141734178|SUPERIORITY_OR_OTHER|||||||0.47|||||||Regression, Linear|||||||0.47
71113242|NCT00935493|141734179|SUPERIORITY_OR_OTHER|||||||0.67|||||||Regression, Logistic|||||||0.67
71113243|NCT00935493|141734179|SUPERIORITY_OR_OTHER|||||||0.46|||||||Regression, Logistic|||||||0.46
71113244|NCT00935493|141734180|SUPERIORITY_OR_OTHER|||||||0.65|||||||Regression, Linear|||||||0.65
71069440|NCT00972816|141647979|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|3.597|||||TWO_SIDED|95.0|2.646|4.89||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||4.89|2.646|
71113245|NCT00935493|141734180|SUPERIORITY_OR_OTHER|||||||0.46|||||||Regression, Linear|||||||0.46
71069441|NCT02163226|141647994|OTHER|2 sided p value||||||0.03|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 2 weeks||||.03
71069442|NCT02163226|141647994|SUPERIORITY|||||||0.19|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 1 month||||.19
71069443|NCT02163226|141647994|OTHER|2 sided p value||||||0.04|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 3 months||||.04
71069444|NCT02163226|141647994|SUPERIORITY|||||||0.89|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 6 months||||.89
71069445|NCT02163226|141647994|SUPERIORITY|||||||0.07|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 9 months||||.07
71113246|NCT00904670|141734204|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-12.46|STANDARD_ERROR_OF_MEAN|1.13|<|0.0001|TWO_SIDED|95.0|-14.75|-10.17|||ANOVA|||Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-10.17|-14.75|<0.0001
71113247|NCT00904670|141734205|SUPERIORITY_OR_OTHER||LS mean difference|-6.32|STANDARD_ERROR_OF_MEAN|1.09|<|0.0001|TWO_SIDED|95.0|-8.53|-4.11|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-4.11|-8.53|<0.0001
71113248|NCT00904670|141734205|SUPERIORITY_OR_OTHER||LS mean difference|-9.98|STANDARD_ERROR_OF_MEAN|1.02|<|0.0001|TWO_SIDED|95.0|-12.04|-7.91|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-7.91|-12.04|<0.0001
71113249|NCT00904670|141734205|SUPERIORITY_OR_OTHER||LS mean difference|-9.33|STANDARD_ERROR_OF_MEAN|1.28|<|0.0001|TWO_SIDED|95.0|-11.92|-6.75|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-6.75|-11.92|<0.0001
71113250|NCT00904670|141734205|SUPERIORITY_OR_OTHER||LS mean difference|-3.79|STANDARD_ERROR_OF_MEAN|1.11||0.0016|TWO_SIDED|95.0|-6.04|-1.54|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.54|-6.04|0.0016
71069446|NCT02163226|141647994|OTHER|2 sided p value||||||0.03|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 2 weeks||||.03
71069447|NCT02163226|141647994|OTHER|2 sided p value||||||0.19|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 1 month||||.19
71069448|NCT02163226|141647994|OTHER|2 sided p value||||||0.04|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 3 months||||.04
71069449|NCT02163226|141647994|OTHER|2 sided p value||||||0.89|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 6 months||||.89
71069450|NCT02163226|141647994|OTHER|2 sided p value||||||0.07|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 9 months||||.07
71069451|NCT02163226|141647995|OTHER|2 sided p value||||||0.01|||||||Fisher Exact|||Pain response Rates (CR+PR) at 2 weeks||||.01
71069452|NCT02163226|141647995|OTHER|2 sided p value||||||0.15|||||||Fisher Exact|||Pain response Rates (CR+PR) at 1 month||||.15
71069453|NCT02163226|141647995|OTHER|2 sided p value||||||0.04|||||||Fisher Exact|||Pain response Rates (CR+PR) at 3 months||||.04
71069454|NCT02163226|141647995|OTHER|2 sided p valued||||||0.78|||||||Fisher Exact|||Pain response Rates (CR+PR) at 6 months||||.78
71069455|NCT02163226|141647995|OTHER|2 sided p valued||||||0.04|||||||Fisher Exact|||Pain response Rates (CR+PR) at 9 months||||.04
71069456|NCT02163226|141647995|OTHER|2 sided p valued||||||0.01|||||||Fisher Exact|||Pain response Rates (CR+PR) at 2 weeks||||.01
71069457|NCT02163226|141647995|OTHER|2 sided p value||||||0.15|||||||Fisher Exact|||Pain response Rates (CR+PR) at 1 month||||.15
71069458|NCT02163226|141647995|OTHER|2 sided p value||||||0.04|||||||Fisher Exact|||Pain response Rates (CR+PR) at 3 months||||.04
71069459|NCT02163226|141647995|OTHER|2 sided p value||||||0.78|||||||Fisher Exact|||Pain response Rates (CR+PR) at 6 months||||.78
71069460|NCT02163226|141647995|OTHER|2 sided p value||||||0.04|||||||Fisher Exact|||Pain response Rates (CR+PR) at 9 months||||.04
71069461|NCT01585324|141648002|SUPERIORITY_OR_OTHER|||||||0.8333|TWO_SIDED||||||ANCOVA|The analysis of covariance (ANCOVA) test for the efficacy of SVR achievement (Yes/No), treatment adjustment and baseline hemoglobin value was used.||||||0.8333
71069462|NCT01585324|141648004|SUPERIORITY_OR_OTHER|||||||0.0867|TWO_SIDED||||||Fisher Exact|||||||0.0867
71069463|NCT01585324|141648006|SUPERIORITY_OR_OTHER|||||||0.6492|TWO_SIDED||||||ANCOVA|||||||0.6492
71069464|NCT01585324|141648008|SUPERIORITY_OR_OTHER|||||||0.0333|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0333
71069465|NCT00601172|141648122|SUPERIORITY_OR_OTHER||difference in percentage of participants|1.0||||0.7273|TWO_SIDED|95.0|-4.6|6.6||p-value based on normal approximation to the binomial using a pooled Z test.|Pooled Z test||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg||6.6|-4.6|0.7273
71069466|NCT00601172|141648123|SUPERIORITY_OR_OTHER||Difference in percentage of participants|1.0||||0.4771|TWO_SIDED|95.0|-1.8|3.8||p-value based on normal approximation to the binomial using a pooled Z test.|Pooled Z test||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg||3.8|-1.8|0.4771
71069467|NCT00601172|141648124|SUPERIORITY_OR_OTHER||Difference in percentage of participants|1.0||||0.7273|TWO_SIDED|95.0|-4.6|6.6|||Pooled Z test|p-value based on normal approximation to the binomial using a pooled Z test.|The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg||6.6|-4.6|0.7273
71069468|NCT00601172|141648125|SUPERIORITY_OR_OTHER||Treatment difference (%)|6.0||||0.0317|TWO_SIDED|95.0|0.5|11.5||p-value based on normal approximation to the binomial using a pooled Z test.|Pooled Z test|||Placebo vs Casopitant 90 mg||11.5|0.5|0.0317
71069469|NCT00601172|141648126|SUPERIORITY_OR_OTHER|||||||0.056|||||||Wilcoxon-rank sum test|||Placebo vs Casopitant 90 mg (0-120 hours)||||0.0560
71069470|NCT00601172|141648126|SUPERIORITY_OR_OTHER|||||||0.0443|||||||Wilcoxon-rank sum test|||Placebo vs Casopitant 90 mg (0-24 hours)||||0.0443
71069471|NCT00601172|141648126|SUPERIORITY_OR_OTHER|||||||0.1709|||||||Wilcoxon-rank sum test|||Placebo vs Casopitant 90 mg (24-120 hours)||||0.1709
71069472|NCT00601172|141648127|SUPERIORITY_OR_OTHER||Treatment difference (%)|-1.8||||0.3986|TWO_SIDED|95.0|-5.9|2.3|||Chi-squared|||Placebo vs Casopitant 90 mg (0-120 hours)||2.3|-5.9|0.3986
71069473|NCT00601172|141648127|SUPERIORITY_OR_OTHER||Treatment difference (%)|-0.9||||0.3545|TWO_SIDED|95.0|-2.7|1.0|||Chi-squared|||Placebo vs Casopitant 90 mg (0-24 hours)||1.0|-2.7|0.3545
71069474|NCT00601172|141648127|SUPERIORITY_OR_OTHER||Treatment difference (%)|-1.8||||0.3986|TWO_SIDED|95.0|-5.9|2.3|||Chi-squared|||Placebo vs Casopitant 90 mg (24-120 hours)||2.3|-5.9|0.3986
71069475|NCT00601172|141648128|SUPERIORITY_OR_OTHER||Treament Difference (%)|-0.9||||0.6795|TWO_SIDED|95.0|-5.4|3.5|||Chi-squared|||Placebo vs Casopitant 90 mg (0-120 hours)||3.5|-5.4|0.6795
71069476|NCT00601172|141648128|SUPERIORITY_OR_OTHER||Treament Difference (%)|-0.9||||0.4507|TWO_SIDED|95.0|-3.1|1.4|||Chi-squared|||Placebo vs Casopitant 90 mg (0-24 hours)||1.4|-3.1|0.4507
71069477|NCT00601172|141648128|SUPERIORITY_OR_OTHER||Treament Difference (%)|-0.9||||0.6795|TWO_SIDED|95.0|-5.4|3.5|||Chi-squared|||Placebo vs Casopitant 90 mg (24-120 hours)||3.5|-5.4|0.6795
71069478|NCT00601172|141648129|SUPERIORITY_OR_OTHER||Difference in percentage of participants|2.1||||0.4846|TWO_SIDED|95.0|-3.8|8.0|||Chi-squared||Difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-120 hours)||8.0|-3.8|0.4846
71069479|NCT00601172|141648129|SUPERIORITY_OR_OTHER||Difference in percentage of participants|0.8||||0.6101|TWO_SIDED|95.0|-2.3|3.9|||Chi-squared||Difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-24 hours)||3.9|-2.3|0.6101
71069480|NCT00601172|141648129|SUPERIORITY_OR_OTHER||Percentage of participants|2.1||||0.4846|TWO_SIDED|95.0|-3.8|8.0|||Chi-squared||Difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (24-120 hours)||8.0|-3.8|0.4846
71079325|NCT00424593|141666190|SUPERIORITY_OR_OTHER|||||||0.329||95.0||||P-value for Week 13 Change from Baseline.|ANCOVA|||||||0.329
71069481|NCT00601172|141648130|SUPERIORITY_OR_OTHER||Difference in percentage of participants|3.8||||0.1356|TWO_SIDED|95.0|-1.2|8.9|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-24 hours)||8.9|-1.2|0.1356
71069482|NCT00601172|141648130|SUPERIORITY_OR_OTHER||Difference in percentage of participants|8.1||||0.028|TWO_SIDED|95.0|0.9|15.4|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-120 hours)||15.4|0.9|0.0280
70852802|NCT02744040|141194419|OTHER|||||||0.057||||||Multiple hypothesis testing was performed using Tukey's HSD procedure.|Mixed Effects Models|||TILDA stimulation reservoir measure at the time of ART initiation in each of the three EDDI groups||||0.057
70941930|NCT03866434|141384009|EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%.|% ratio of Geometric LS means|85.527|||||TWO_SIDED|90.0|78.163|93.584|||ANOVA|A 2-factor analysis of variance (ANOVA) model with fixed factors for treatment and participant was fitted to the natural logtransformed PK parameters.|This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole \[Day 8\] versus anagrelide alone \[Day 1\]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the LS mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CI were calculated.||93.584|78.163|
71069483|NCT00601172|141648130|SUPERIORITY_OR_OTHER||Difference in percentage of participants|8.1||||0.028|TWO_SIDED|95.0|0.9|15.4|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (24-120 hours)||15.4|0.9|0.0280
71069484|NCT00601172|141648131|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-0.9||||0.7799|TWO_SIDED|95.0|-7.3|5.5|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-120 hours)||5.5|-7.3|0.7799
71069485|NCT00601172|141648131|SUPERIORITY_OR_OTHER||Difference in percentage of participants|0.5||||0.7883|TWO_SIDED|95.0|-3.2|4.2|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-24 hours)||4.2|-3.2|0.7883
71069486|NCT00601172|141648131|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-0.9||||0.7799|TWO_SIDED|95.0|-7.3|5.5|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (24-120 hours)||5.5|-7.3|0.7799
71069487|NCT00601172|141648132|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-7.3||||0.0507|TWO_SIDED|95.0|-15.0|0.0|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-120 hours)||0.0|-15|0.0507
71069488|NCT00601172|141648132|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-4.7||||0.08|TWO_SIDED|95.0|-9.9|0.5|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-24 hours)||0.5|-9.9|0.0800
71069489|NCT00601172|141648132|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-7.3||||0.0507|TWO_SIDED|95.0|-15.0|0.0|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (24-120 hours)||0.0|-15|0.0507
71069490|NCT00601172|141648133|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-2.6|||||TWO_SIDED|97.5|-9.9|4.7|||||The parameter estimated was difference in percentage of participants with response.|Nausea Impact: Placebo vs. Casopitant 90 mg; Cycle 1 (0-120 hours)||4.7|-9.9|
71069491|NCT00601172|141648133|SUPERIORITY_OR_OTHER||Difference in percentage of participants|0.7||||||97.5|-5.2|6.6|||||The parameter estimated was difference in percentage of participants with response.|Vomiting Impact: Placebo vs. Casopitant 90 mg; Cycle 1 (0-120 hours)||6.6|-5.2|
71069492|NCT00601172|141648134|SUPERIORITY_OR_OTHER|||||||0.1572|||||||Chi-squared|||Placebo vs. Casopitant 90 mg: (0-120 hours) in Cycle 1||||0.1572
71069493|NCT00601172|141648134|SUPERIORITY_OR_OTHER|||||||0.2908|||||||Chi-squared|||Placebo vs. Casopitant 90 mg: (0-24 hours) in Cycle 1||||0.2908
71069494|NCT00601172|141648134|SUPERIORITY_OR_OTHER|||||||0.1572|||||||Chi-squared|||Placebo vs. Casopitant 90 mg: (24-120 hours) in Cycle 1||||0.1572
71069495|NCT03917472|141648161|SUPERIORITY|(1-sided)|LS mean difference|1.1|STANDARD_ERROR_OF_MEAN|0.89||0.099|TWO_SIDED|95.0|-0.6|2.9|||ANOVA|||||2.9|-0.6|0.099
71069496|NCT03917472|141648161|NON_INFERIORITY|(4-letter margin) (1-sided)|||||<|0.001|||||||ANOVA|||||||<0.001
71069497|NCT03917472|141648162|SUPERIORITY|(1-sided); Week 52|LS mean difference|-41.4|STANDARD_ERROR_OF_MEAN|8.94|<|0.001|TWO_SIDED|95.0|-58.9|-23.8|||ANOVA|||||-23.8|-58.9|<0.001
71069498|NCT03917472|141648163|SUPERIORITY|(1-sided) Week 52|Difference - %|20.0|||<|0.001|TWO_SIDED|95.0|12.5|28.6|||Clopper-Pearson exact method.|||||28.6|12.5|<0.001
71069499|NCT03917472|141648170|OTHER|Descriptive|Difference - %|9.3|||||TWO_SIDED|95.0|1.7|17.0|||Clopper-Pearson exact method|||≥ 5 letters gain from baseline or BCVA ≥ 84 letters at Week 52||17.0|1.7|
71069500|NCT03917472|141648170|OTHER|Descriptive|Difference - %|7.7|||||TWO_SIDED|95.0|-1.5|17.0|||Clopper-Pearson exact method|||≥ 10 letters gain from baseline or BCVA ≥ 84 letters at Week 52||17.0|-1.5|
71069501|NCT03917472|141648170|OTHER|Descriptive|Difference - %|5.5|||||TWO_SIDED|95.0|-2.7|14.3|||Clopper-Pearson exact method|||≥ 15 letters gain from baseline or BCVA ≥ 84 letters at Week 52||14.3|-2.7|
71069502|NCT03917472|141648171|OTHER|descriptive; week 12|Difference - %|8.3|||||TWO_SIDED|95.0|0.2|16.5|||Clopper-Pearson exact method|||||16.5|0.2|
71069503|NCT03917472|141648171|OTHER|descriptive; week 24|Difference - %|6.0|||||TWO_SIDED|95.0|-3.0|14.9|||Clopper-Pearson exact method|||||14.9|-3.0|
71069504|NCT03917472|141648171|NON_INFERIORITY|(10% margin); week 52|Difference - %|6.0||||0.002|TWO_SIDED|95.0|-3.9|16.1||(10% margin) (1-sided)|Clopper-Pearson exact method|||||16.1|-3.9|0.002
71069505|NCT03917472|141648172|OTHER|descriptive; week 12|Difference - %|2.0|||||TWO_SIDED|95.0|-2.5|6.6|||Clopper-Pearson exact method|||||6.6|-2.5|
71069506|NCT03917472|141648172|OTHER|descriptive; week 24|Difference - %|2.4|||||TWO_SIDED|95.0|-3.0|7.7|||Clopper-Pearson exact method|||||7.7|-3.0|
71069507|NCT03917472|141648172|OTHER|descriptive; week 52|Difference - %|3.9|||||TWO_SIDED|95.0|-2.0|9.8|||Clopper-Pearson exact method|||||9.8|-2.0|
71069508|NCT01669174|141648206|SUPERIORITY_OR_OTHER||Mean Difference (Net)|106.1|||<|0.001|TWO_SIDED|90.0|104.64|107.58|||ANCOVA|||Week 4||107.58|104.64|<0.001
71069509|NCT01669174|141648206|SUPERIORITY_OR_OTHER||Median Difference (Net)|107.75|||<|0.001|TWO_SIDED|90.0|106.18|109.35|||ANCOVA|||Week 8||109.35|106.18|<0.001
71029038|NCT01062256|141565695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.438|TWO_SIDED|95.0|0.71|1.16||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site and baseline of cough bouts terms with log(exposure time)as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 2-hour postdose period.||1.16|0.71|0.438
71069510|NCT01669174|141648206|SUPERIORITY_OR_OTHER||Median Difference (Net)|108.63|||<|0.001|TWO_SIDED|90.0|106.31|111.0|||ANCOVA|||Week 16||111.00|106.31|<0.001
71069511|NCT01669174|141648206|SUPERIORITY_OR_OTHER||Median Difference (Net)|106.63|||<|0.001|TWO_SIDED|90.0|104.39|108.93|||ANCOVA|||Week 24||108.93|104.39|<0.001
71069512|NCT01953601|141648221|SUPERIORITY||Difference in Least Squares Mean (LSM)|0.1||||0.6734|TWO_SIDED|97.51|-0.3|0.4|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.4|-0.3|0.6734
71069513|NCT01953601|141648221|SUPERIORITY||Difference in Least Squares Means (LSM)|0.4||||0.0141|TWO_SIDED|97.51|0.0|0.8|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.8|0.0|0.0141
71069514|NCT01953601|141648223|OTHER||Difference in % vs Placebo|4.32|||||TWO_SIDED|95.0|0.4|8.31|||||Difference in % = Arm A - Arm C|||8.31|0.40|
71069515|NCT01953601|141648223|OTHER||Difference in % vs Placebo|5.17|||||TWO_SIDED|95.0|1.33|9.09|||||Difference in % = Arm B - Arm C|||9.09|1.33|
71069516|NCT01953601|141648224|OTHER||Difference in % vs Placebo|2.08|||||TWO_SIDED|95.0|-0.84|5.1|||||Difference in % = Arm A - Arm C|||5.10|-0.84|
71029039|NCT01062256|141565695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.497|TWO_SIDED|95.0|0.87|1.34||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site and baseline of cough bouts terms with log(exposure time)as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 2-hour postdose period.||1.34|0.87|0.497
71029040|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.25|TWO_SIDED|95.0|0.64|1.12||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts within 15 minutes postdose||1.12|0.64|0.250
71029041|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.802|TWO_SIDED|95.0|0.75|1.25||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts within 15 minutes postdose||1.25|0.75|0.802
71029042|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.188|TWO_SIDED|95.0|0.94|1.39||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts within 15 minutes postdose||1.39|0.94|0.188
71029043|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.091|TWO_SIDED|95.0|0.58|1.04||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 15 and 30 minutes postdose||1.04|0.58|0.091
71029044|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.465|TWO_SIDED|95.0|0.69|1.19||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 15 and 30 minutes postdose||1.19|0.69|0.465
71029045|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.207|TWO_SIDED|95.0|0.92|1.46||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 15 and 30 minutes postdose||1.46|0.92|0.207
71069517|NCT01953601|141648224|OTHER||Difference in % vs Placebo|5.58|||||TWO_SIDED|95.0|2.35|8.99|||||Difference in % = Arm B - Arm C|||8.99|2.35|
71069518|NCT01953601|141648225|OTHER||Difference in % vs Placebo|-6.79|||||TWO_SIDED|95.0|-16.16|2.68|||||Difference in % = Arm A - Arm C|||2.68|-16.16|
71069519|NCT01953601|141648225|OTHER||Difference in % vs Placebo|-10.68|||||TWO_SIDED|95.0|-20.16|-1.04|||||Difference in % = Arm B - Arm C|||-1.04|-20.16|
71069520|NCT01953601|141648226|OTHER||Difference in % vs Placebo|-2.42|||||TWO_SIDED|95.0|-6.03|0.61|||||Difference in % = Arm A - Arm C|||0.61|-6.03|
71069521|NCT01953601|141648226|OTHER||Difference in % vs Placebo|-2.38|||||TWO_SIDED|95.0|-6.01|0.71|||||Difference in % = Arm B - Arm C|||0.71|-6.01|
71069522|NCT01953601|141648227|SUPERIORITY||Hazard Ratio (HR)|1.301||||0.0222|TWO_SIDED|97.51|1.005|1.684|||Regression, Cox||HR = Arm A / Arm C||Based on Cox regression model with Efron's method of tie handling with treatment, background AD treatment (use, no use), sex, APOE4 status (carrier, non-carrier) and baseline use of Vitamin E as categorical covariates and age and baseline MMSE value as continuous covariates.|1.684|1.005|0.0222
71069523|NCT01953601|141648227|SUPERIORITY||Hazard Ratio (HR)|1.382||||0.005|TWO_SIDED|97.51|1.067|1.79|||Regression, Cox||HR = Arm B / Arm C||Based on Cox regression model with Efron's method of tie handling with treatment, background AD treatment (use, no use), sex, APOE4 status (carrier, non-carrier) and baseline use of Vitamin E as categorical covariates and age and baseline MMSE value as continuous covariates.|1.790|1.067|0.0050
71069524|NCT01953601|141648228|SUPERIORITY||Difference in Least Squares Mean (LSM)|0.0||||0.9109|TWO_SIDED|97.51|-0.3|0.4|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.4|-0.3|0.9109
71069525|NCT01953601|141648228|SUPERIORITY||Difference in Least Squares Mean (LSM)|0.3||||0.0824|TWO_SIDED|97.51|-0.1|0.7|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.7|-0.1|0.0824
71069526|NCT01953601|141648229|SUPERIORITY||Difference in Least Squares Mean (LSM)|0.0||||0.951|TWO_SIDED|97.51|-0.2|0.2|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.2|-0.2|0.9510
71069527|NCT01953601|141648229|SUPERIORITY||Difference in Least Squares Mean (LSM)|0.0||||0.9392|TWO_SIDED|97.51|-0.2|0.2|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.2|-0.2|0.9392
71069528|NCT01953601|141648230|SUPERIORITY||Difference in Least Squares Mean (LSM)|-0.4||||0.1133|TWO_SIDED|97.51|-1.0|0.2|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.2|-1.0|0.1133
71069529|NCT01953601|141648230|SUPERIORITY||Difference in Least Squares Mean (LSM)|-0.6||||0.031|TWO_SIDED|97.51|-1.2|0.0|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.0|-1.2|0.0310
71079326|NCT00424593|141666191|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-value for Mental Component Summary Change from Baseline.|ANCOVA|||||||0.051
71079327|NCT00424593|141666191|SUPERIORITY_OR_OTHER|||||||0.22||95.0||||P-value for Physical Component Summary Change from Baseline.|ANCOVA|||||||0.220
71079328|NCT00424593|141666191|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||P-value for Bodily Pain Change from Baseline.|ANCOVA|||||||0.038
71079329|NCT00424593|141666191|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||P-value for General Health Change from Baseline.|ANCOVA|||||||0.041
71079330|NCT00424593|141666191|SUPERIORITY_OR_OTHER|||||||0.093||95.0||||P-value for Mental Health Change from Baseline.|ANCOVA|||||||0.093
71079331|NCT00424593|141666191|SUPERIORITY_OR_OTHER|||||||0.21||95.0||||P-value for Physical Functioning Change from Baseline.|ANCOVA|||||||0.210
71079332|NCT00424593|141666191|SUPERIORITY_OR_OTHER|||||||0.17||95.0||||P-value for Role-Emotional Change from Baseline.|ANCOVA|||||||0.170
71079333|NCT00424593|141666191|SUPERIORITY_OR_OTHER|||||||0.306||95.0||||P-value for Role-Physical Change from Baseline.|ANCOVA|||||||0.306
71079334|NCT00424593|141666191|SUPERIORITY_OR_OTHER|||||||0.053||95.0||||P-value for Social Functioning Change from Baseline.|ANCOVA|||||||0.053
71079335|NCT00424593|141666191|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||P-value for Vitality Change from Baseline.|ANCOVA|||||||0.040
71079336|NCT00424593|141666192|SUPERIORITY_OR_OTHER|||||||0.117||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.117
71079337|NCT00424593|141666193|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||P-value for Absenteeism Week 13 Change from Baseline.|ANCOVA|||||||0.063
71079338|NCT00424593|141666193|SUPERIORITY_OR_OTHER|||||||0.452||95.0||||P-value for Presenteeism Week 13 Change from Baseline.|ANCOVA|||||||0.452
71079339|NCT00424593|141666193|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||P-value for Work Productivity Loss Week 13 Change from Baseline.|ANCOVA|||||||0.736
71079340|NCT00424593|141666193|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Work Activity Impairment Week 13 Change from Baseline.|ANCOVA|||||||0.002
71079341|NCT00424593|141666194|SUPERIORITY_OR_OTHER|||||||0.177||95.0||||P-value for Week 13 Change from Baseline.|ANCOVA|||||||0.177
71113251|NCT00904670|141734205|SUPERIORITY_OR_OTHER||LS mean difference|-4.77|STANDARD_ERROR_OF_MEAN|1.4||0.0016|TWO_SIDED|95.0|-7.61|-1.94|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.94|-7.61|0.0016
71113252|NCT00904670|141734206|SUPERIORITY_OR_OTHER||LS mean difference|-1.12|STANDARD_ERROR_OF_MEAN|0.38||0.0051|TWO_SIDED|95.0|-1.88|-0.36|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.36|-1.88|0.0051
71113253|NCT00904670|141734206|SUPERIORITY_OR_OTHER||LS mean difference|-1.59|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-2.23|-0.95|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.95|-2.23|<0.0001
71113254|NCT00904670|141734206|SUPERIORITY_OR_OTHER||LS mean difference|-2.28|STANDARD_ERROR_OF_MEAN|0.54||0.0001|TWO_SIDED|95.0|-3.37|-1.2|||ANOVA|||Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.20|-3.37|0.0001
71113255|NCT00904670|141734206|SUPERIORITY_OR_OTHER||LS mean difference|-1.49|STANDARD_ERROR_OF_MEAN|0.51||0.0055|TWO_SIDED|95.0|-2.52|-0.47|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.47|-2.52|0.0055
71113256|NCT00904670|141734206|SUPERIORITY_OR_OTHER||LS mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.41||0.1977|TWO_SIDED|95.0|-1.38|0.29|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||0.29|-1.38|0.1977
71113257|NCT00904670|141734206|SUPERIORITY_OR_OTHER||LS mean difference|-0.88|STANDARD_ERROR_OF_MEAN|0.43||0.0491|TWO_SIDED|95.0|-1.76|0.0|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||0.00|-1.76|0.0491
71113258|NCT00904670|141734207|SUPERIORITY_OR_OTHER||LS mean difference|-1.69|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-2.36|-1.02|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.02|-2.36|<0.0001
71069530|NCT01953601|141648231|SUPERIORITY||Difference in Least Squares Mean (LSM)|-0.05|||<|0.0001|TWO_SIDED|97.51|-0.06|-0.04|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|-0.04|-0.06|<0.0001
71069531|NCT01953601|141648231|SUPERIORITY||Difference in Least Squares Mean (LSM)|-0.06|||<|0.0001|TWO_SIDED|97.51|-0.07|-0.05|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|-0.05|-0.07|<0.0001
71069532|NCT01953601|141648232|SUPERIORITY||Difference in Least Squares Mean (LSM)|-1.0||||0.096|TWO_SIDED|97.51|-2.4|0.4|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.4|-2.4|0.0960
71069533|NCT01953601|141648232|SUPERIORITY||Difference in Least Squares Mean (LSM)|-1.7||||0.011|TWO_SIDED|97.51|-3.2|-0.2|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|-0.2|-3.2|0.0110
71069534|NCT02991729|141648234|NON_INFERIORITY|The non-inferiority limit was 1 point on the questionnaire scale.||||||0.929||||||a priori threshold for statistical significance was p\<0.05.|Wilcoxon rank-sum|||||||0.929
71069535|NCT02991729|141648235|SUPERIORITY|||||||0.369|||||||Wilcoxon rank-sum|||Decisional conflict was measured in 2 separate time points in the experimental group - both prior to and following genetic counseling. This analysis compares decisional conflict in the routine care group (after counseling only) to the experimental group following decision aid completion but prior to genetic counseling (first row, second column in above table).||||0.369
71069536|NCT02991729|141648235|SUPERIORITY|||||||0.003|||||||Wilcoxon rank-sum|||Decisional conflict was measured in 2 separate time points in the experimental group - both prior to and following genetic counseling. This analysis compares decisional conflict in the routine care group (after counseling only) to the experimental group following decision aid completion and genetic counseling (second row, second column in above table).||||0.003
71069537|NCT02991729|141648235|SUPERIORITY|||||||0.003|||||||Wilcoxon signed-rank|||Decisional conflict was measured in 2 separate time points in the experimental group - both prior to and following genetic counseling. This analysis compares decisional conflict pre-genetic counseling/post-decision aid to post-genetic counseling.||||0.003
71069538|NCT02230696|141648238|EQUIVALENCE|provides 85% power of success|Equivalence ratio|94.19|||||TWO_SIDED|90.0|84.77|104.52|||Trial and Error approach|||||104.52|84.77|
71069539|NCT02230696|141648239|EQUIVALENCE|provides 85% power of success|Equivalence ratio|94.68|||||TWO_SIDED|90.0|84.86|105.54|||Trial and Error approach|||||105.54|84.86|
71069540|NCT01154296|141648241|SUPERIORITY_OR_OTHER||adjusted risk ratio (aRR)|1.12|||||TWO_SIDED|95.0|0.94|1.33||In the statistical tests of all hypotheses and calculation of the presented risk ratios, we used multiple imputations of data sets with all 5012 cases. The aRRs reported are based on the multiply imputed data. Counts are based on the observed data.|Mantel Haenszel|||A total of 2039/2505 participants randomized to the counseling group and 2032/2507 to the information-only group had complete follow-up STI data. Cumulative STI incidence was 250/2039 (12.3%) in the counseling group and 226/2032 (11.1%) in the information-only group (aRR, 1.12; 95%CI, 0.94-1.33).||1.33|0.94|
71069541|NCT01154296|141648242|SUPERIORITY_OR_OTHER||Incidence rate ratio (IRR)|0.99|||||TWO_SIDED|95.0|0.9|1.09|||||In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.|Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.||1.09|0.90|
71069542|NCT01154296|141648243|SUPERIORITY_OR_OTHER||Incidence Rate Ratio (IRR)|0.98|||||TWO_SIDED|95.0|0.86|1.13|||||In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.|Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.||1.13|0.86|
71079342|NCT00424593|141666195|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||P-value for Anxiety Subscale Change from Baseline.|ANCOVA|||||||0.122
71079343|NCT00424593|141666195|SUPERIORITY_OR_OTHER|||||||0.262||95.0||||P-value for Depression Subscale Change from Baseline.|ANCOVA|||||||0.262
71029046|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.122|TWO_SIDED|95.0|0.62|1.06||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 30 and 45 minutes postdose||1.06|0.62|0.122
71029047|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.165|TWO_SIDED|95.0|0.66|1.07||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 30 and 45 minutes postdose||1.07|0.66|0.165
71029048|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.711|TWO_SIDED|95.0|0.83|1.32||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 30 and 45 minutes postdose||1.32|0.83|0.711
71069543|NCT01154296|141648244|SUPERIORITY_OR_OTHER||Incidence Rate Ratio (IRR)|0.88|||||TWO_SIDED|95.0|0.82|0.94|||||In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.|Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.||0.94|0.82|
71069544|NCT01154296|141648245|SUPERIORITY_OR_OTHER||Incidence Rate Ratio (IRR)|0.97|||||TWO_SIDED|95.0|0.9|1.05|||||In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.|Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.||1.05|0.90|
71069545|NCT01154296|141648246|SUPERIORITY_OR_OTHER||Adjusted Risk Ratio (aRR)|1.14||||||95.0|0.89|1.46||In the statistical tests of all hypotheses and calculation of the presented risk ratios, we used multiple imputations of data sets with all 5012 cases. The aRRs reported are based on the multiply imputed data. Counts are based on the observed data.|Mantel Haenszel|||||1.46|0.89|
71069546|NCT05537441|141648247|SUPERIORITY||Percent Difference|0.64||||0.216|TWO_SIDED||||||2 proportion Z-test|||||||0.216
71069547|NCT05537441|141648248|SUPERIORITY||Percent Difference|-0.61||||0.34|TWO_SIDED||||||2 proportion Z-test|||Previously vaccinated||||0.34
71069548|NCT05537441|141648248|SUPERIORITY||Percent Difference|-0.45||||0.247|TWO_SIDED||||||2 proportion Z-test|||Previously unvaccinated||||0.247
71069549|NCT05225298|141648252|OTHER|||||||0.9||||||A p-value of \< 0.05 would be considered statistically significant|log binomial model|||||||0.90
71069550|NCT05225298|141648253|OTHER|||||||0.94||||||A p-value of \< 0.05 would be considered statistically significant|log binomial model|||||||0.94
71069551|NCT05225298|141648254|OTHER|||||||0.053|||||||log binomial model|||||||0.053
71069552|NCT02877095|141648260|OTHER|||||||||||||||||All subjects on study received active drug.|Total count of events is provided.|||
71069553|NCT02223650|141648261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75||||0.01|TWO_SIDED|95.0|-1.42|-0.07||P-value is calculated for one-sided hypothesis test.|ANCOVA|Comparison of mean 8-wk distance control using ANCOVA adjusted for baseline distance control pre-study spectacle wear, and pre-study IXT treatment|Difference in mean distance control (overminus - observation) and 95% CI from ANCOVA model adjusting for baseline control, pre-study spectacle wear, and pre-study treatment for IXT. + difference suggests observation group worse than overminus group|||-0.07|-1.42|0.01
71069554|NCT02223650|141648262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.14|TWO_SIDED|95.0|-0.68|0.19||P-value is calculated for one-sided hypothesis test.|ANCOVA|Comparison of mean 8-wk near control using ANCOVA adjusted for baseline near control pre-study spectacle wear, and pre-study IXT treatment.|Comparison of mean 8-wk distance control using ANCOVA adjusted for baseline near control pre-study spectacle wear, and pre-study IXT treatment.|||0.19|-0.68|0.14
71069555|NCT02223650|141648265|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.0||||0.07|TWO_SIDED|95.0|-6.0|45.0||The p-value was not adjusted for multiple comparisons.|Chi-squared|||||45|-6|0.07
71069556|NCT02223650|141648273|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.001||||0.54|TWO_SIDED|95.0|-23.0|24.0||The p-value was not adjusted for multiple comparisons.|Chi-squared|||||24|-23|0.54
71069557|NCT03320850|141648419|SUPERIORITY||Least Squares Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.635||0.0845|TWO_SIDED|95.0|-0.15|2.35|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|The null hypothesis is that there is no difference between each (BOTOX® and Hydrogel admixture group) and (placebo and Hydrogel admixture) in the mean change from Baseline in daily average number of UIEs at Week 12.||2.35|-0.15|0.0845
71069558|NCT03320850|141648419|SUPERIORITY||Least Squares Mean Difference|1.83|STANDARD_ERROR_OF_MEAN|0.633||0.0041|TWO_SIDED|95.0|0.59|3.08|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|The null hypothesis is that there is no difference between each (BOTOX® and Hydrogel admixture group) and (placebo and Hydrogel admixture) in the mean change from Baseline in daily average number of UIEs at Week 12.||3.08|0.59|0.0041
71069559|NCT03320850|141648419|SUPERIORITY||Least Squares Mean Difference|1.19|STANDARD_ERROR_OF_MEAN|0.632||0.06|TWO_SIDED|95.0|-0.05|2.44|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|The null hypothesis is that there is no difference between each (BOTOX® and Hydrogel admixture group) and (placebo and Hydrogel admixture) in the mean change from Baseline in daily average number of UIEs at Week 12.||2.44|-0.05|0.0600
71069560|NCT03320850|141648419|SUPERIORITY||Least Squares Mean Difference|0.87|STANDARD_ERROR_OF_MEAN|0.631||0.1702|TWO_SIDED|95.0|-0.37|2.11|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|The null hypothesis is that there is no difference between each (BOTOX® and Hydrogel admixture group) and (placebo and Hydrogel admixture) in the mean change from Baseline in daily average number of UIEs at Week 12.||2.11|-0.37|0.1702
71069561|NCT03320850|141648421|SUPERIORITY||Least Square Mean|0.73|STANDARD_ERROR_OF_MEAN|0.617||0.2361|TWO_SIDED|95.0|-0.48|1.95|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||1.95|-0.48|0.2361
71069562|NCT03320850|141648421|SUPERIORITY||Least Square Mean|0.78|STANDARD_ERROR_OF_MEAN|0.608||0.1985|TWO_SIDED|95.0|-0.41|1.98|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||1.98|-0.41|0.1985
71079344|NCT00424593|141666196|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||P-value for Change from Baseline.|ANOVA|ANOVA based on rank transformation.||||||0.046
71069563|NCT03320850|141648421|SUPERIORITY||Least Square Mean|0.64|STANDARD_ERROR_OF_MEAN|0.607||0.2923|TWO_SIDED|95.0|-0.56|1.84|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||1.84|-0.56|0.2923
71069564|NCT03320850|141648421|SUPERIORITY||Least Square Mean|0.54|STANDARD_ERROR_OF_MEAN|0.609||0.3769|TWO_SIDED|95.0|-0.66|1.74|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||1.74|-0.66|0.3769
70941931|NCT03866434|141384010|EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%.|% ratio of Geometric LS means|73.007|||||TWO_SIDED|90.0|62.528|85.243|||ANOVA|A 2-factor analysis of variance (ANOVA) model with fixed factors for treatment and participant was fitted to the natural logtransformed PK parameters.|This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole \[Day 8\] versus anagrelide alone \[Day 1\]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the LS mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CI were calculated.||85.243|62.528|
71069565|NCT03320850|141648422|SUPERIORITY||Least Square Mean|-7.05|STANDARD_ERROR_OF_MEAN|13.107||0.5911|TWO_SIDED|95.0|-32.87|18.77|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||18.77|-32.87|0.5911
70852803|NCT02744040|141194420|OTHER|Tukey's Honest Significant Difference (HSD) test||||||0.01||||||Pair-Wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in TILDA stimulation was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for TILDA Stimulation.||||0.010
70938928|NCT02301299|141378461|OTHER|For power calculation, we assumed that the intervention would be almost fully implemented in May 2016 and the EMS use would be observed until Dec 2017. Therefore, a post-intervention period would be 20 months. To have one-third of the study period as an intervention period, we planned to analyze five-year (60-month) data from January 2013 to December 2017.|||||<|0.0001|||||||Regression, Linear|||The effect size was defined as the sum of expected slope change in monthly EMS use rate over the standard deviation. Assuming an autocorrelation level of 0.3, both level and trend change effect size of 0.5 would be detectable at 90% power at a significance level of 0.05. The effect size is measured in slope of change over time (negative values indicate a decrease while positive values indicate an increase in % EMS use/month).|Using SAS PROC TIMESERIES, individual admission data were aggregated into monthly time series data to calculate a monthly EMS arrival rate. In this procedure, we also generated seasonally adjusted time series data to take into account a seasonal pattern. Using the seasonally adjusted time series data, we conducted linear regression analysis for time series data in PROC AUTOREG. The statistical hypothesis of the regression model was that there are a level change and a slope change after the intervention. In the regression model, we included a time variable to account for a natural trend prior to the intervention introduction (or in absence of the intervention). We assumed that the patient population was stable during the five-year period and no other factors than the intervention affected the outcome; no other potential confounding factors were not considered. A backward elimination was used to correct for autocorrelation. Maximum likelihood method was used to estimate parameters.|||<.0001
70938929|NCT01345253|141378508|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.99||||0.0001|TWO_SIDED|95.0|1.4|2.82|||Regression, Logistic||Odds Ratio (95% CI) and p-value were estimated by a logistic regression model with independent variables treatment group, country, Baseline SELENA SLEDAI score (\<=9 vs. \>=10) and complement (C) levels (low C3 and/or C4 vs. no low C3 or C4).|||2.82|1.40|0.0001
70938930|NCT01345253|141378509|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.0||||0.0001|TWO_SIDED|95.0|1.41|2.83|||Regression, Logistic||Odds Ratio (95% CI) and p-value were estimated by a logistic regression model with independent variables treatment group, country, Baseline SELENA SLEDAI score (\<=9 vs. \>=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4).|||2.83|1.41|0.0001
70938931|NCT01345253|141378510|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.76||||0.0116|TWO_SIDED|95.0|1.13|2.74|||Regression, Logistic||Odds Ratio (95% CI) and p-value were estimated by a logistic regression model with independent variables treatment group, country, baseline SELENA SLEDAI score (\<=9 vs. \>=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4).|||2.74|1.13|0.0116
70938932|NCT01345253|141378511|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0288|||||||Rank ANCOVA|||||||0.0288
71069566|NCT03320850|141648422|SUPERIORITY||Least Square Mean|-8.0|STANDARD_ERROR_OF_MEAN|12.956||0.5375|TWO_SIDED|95.0|-33.52|17.52|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||17.52|-33.52|0.5375
70938933|NCT01345253|141378512|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.5||||0.0004|TWO_SIDED|95.0|0.34|0.73|||Regression, Cox|||||0.73|0.34|0.0004
70938934|NCT00841321|141378525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.1|TWO_SIDED|95.0|-0.5|0.1||Nominal value. Per protocol univariate tests would only be considered significant in the multivariate test was significant.|ANCOVA|||PASAT Exit Z-score least square means difference adjusted for baseline. Positive values indicate a beneficial effect from treatment with Ginkgo.||0.1|-0.5|.1
71029049|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.215|TWO_SIDED|95.0|0.64|1.11||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 45 and 60 minutes postdose||1.11|0.64|0.215
71069567|NCT03320850|141648422|SUPERIORITY||Least Square Mean|-1.33|STANDARD_ERROR_OF_MEAN|12.764||0.9173|TWO_SIDED|95.0|-26.47|23.81|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||23.81|-26.47|0.9173
71069568|NCT03320850|141648422|SUPERIORITY||Least Square Mean|9.33|STANDARD_ERROR_OF_MEAN|12.981||0.473|TWO_SIDED|95.0|-16.24|34.9|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||34.90|-16.24|0.4730
71069569|NCT00507819|141648458|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||Regression, Linear|||||||0.73
71029050|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.367|TWO_SIDED|95.0|0.67|1.16||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 45 and 60 minutes postdose||1.16|0.67|0.367
71029051|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.687|TWO_SIDED|95.0|0.82|1.35||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 45 and 60 minutes postdose||1.35|0.82|0.687
71029052|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.73|TWO_SIDED|95.0|0.67|1.32||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 60 and 75 minutes postdose||1.32|0.67|0.730
71069570|NCT00507819|141648459|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Regression, Linear|||||||0.37
71069571|NCT00507819|141648460|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Regression, Linear|||||||0.05
70938935|NCT00841321|141378525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.007|TWO_SIDED|95.0|-0.9|-0.1||Not adjusted for multiple comparison. Nominal value. Per protocol univariate tests would only be considered significant in the multivariate test was significant.|ANCOVA|||Stroop Exit Z-score least square means difference adjusted for baseline.Positive values indicate a beneficial effect from treatment with Ginkgo.||-0.1|-0.9|0.007
70938936|NCT00841321|141378525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.5|TWO_SIDED|95.0|-0.2|0.3||Not adjusted for multiple comparison. Nominal value. Per protocol univariate tests would only be considered significant in the multivariate test was significant.|ANCOVA|||COWAT Exit Z-score least square means difference adjusted for baseline. Positive values indicate a beneficial effect from treatment with Ginkgo.||0.3|-0.2|0.5
70938937|NCT00841321|141378525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.15||0.5||95.0|-0.3|0.3||Not adjusted for multiple comparison. Nominal value. Per protocol univariate tests would only be considered significant in the multivariate test was significant.|ANCOVA|||CVLT-II Delayed Recall Exit Z-score least square means difference adjusted for baseline. Positive values indicate a beneficial effect from treatment with Ginkgo.||0.3|-0.3|0.5
70938938|NCT00841321|141378525|SUPERIORITY_OR_OTHER|||||||0.19|||||||MANCOVA|MANCOVA||MANCOVA for all four cognitive tests at exit adjusting for baseline. Individual ANOVAs were to follow if the multivariate test was significant.||||0.19
70938939|NCT00841321|141378526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|2.7||0.4|TWO_SIDED|95.0|-5.7|4.7|||ANCOVA||Positive values indicate a beneficial effect from Ginkgo.|Perceived Deficits Questionnaire||4.7|-5.7|0.4
70938940|NCT00841321|141378526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|2.0||0.7||95.0|-3.2|4.8|||ANCOVA||Positive values indicate a beneficial effect from Ginkgo.|Multiple Sclerosis Neuropsychological Questionnaire||4.8|-3.2|0.7
70938941|NCT00841321|141378526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.6||0.4||95.0|-1.3|0.8|||ANCOVA|||Community Integration Questionnaire||0.8|-1.3|0.4
70938942|NCT02379078|141378527|SUPERIORITY|||||||0.0246|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.0246
70938943|NCT02379078|141378528|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
70938944|NCT02379078|141378529|SUPERIORITY|||||||0.12|||||||Mixed Models Analysis|||||||0.12
70938945|NCT02379078|141378530|SUPERIORITY|||||||0.468|||||||Mixed Models Analysis|||||||0.468
70938946|NCT02379078|141378531|SUPERIORITY|||||||0.6|||||||ANOVA|||||||0.60
70938947|NCT04908488|141378532|NON_INFERIORITY|Noninferiority in distance VA was declared if upper confidence limit was less than 0.05.|Least Squares Means Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.004|||ONE_SIDED|95.0||-0.01|||Mixed effects repeated measures model|Within subject correlation due to eye and the crossover design were accounted for in the model.|Lens difference (P1fA minus AMfA)|||-0.01||
70938948|NCT00657709|141378541|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for 44/76-SL strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.9|||||TWO_SIDED|95.0|0.81|0.99|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot2 for 44/76-SL strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||0.99|0.81|
71029053|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.923|TWO_SIDED|95.0|0.74|1.39||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 60 and 75 minutes postdose||1.39|0.74|0.923
71029054|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.573|TWO_SIDED|95.0|0.83|1.4||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 60 and 75 minutes postdose||1.40|0.83|0.573
71029055|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.289|TWO_SIDED|95.0|0.61|1.16||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 75 and 90 minutes postdose||1.16|0.61|0.289
71029056|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.379|TWO_SIDED|95.0|0.64|1.18||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 75 and 90 minutes postdose||1.18|0.64|0.379
71029057|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.785|TWO_SIDED|95.0|0.79|1.37||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 75 and 90 minutes postdose||1.37|0.79|0.785
71029058|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.194|TWO_SIDED|95.0|0.6|1.11||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 90 and 105 minutes postdose||1.11|0.60|0.194
71029059|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.212|TWO_SIDED|95.0|0.62|1.11||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 90 and 105 minutes postdose||1.11|0.62|0.212
70852804|NCT02744040|141194420|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in TILDA stimulation was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for TILDA Stimulation.||||<0.0001
70852805|NCT02744040|141194420|OTHER|Tukey's Honest Significant Difference (HSD) test|||||>|0.05||||||Pair-Wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in TILDA stimulation was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for TILDA Stimulation.||||>0.05
71069572|NCT00507819|141648461|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Regression, Linear|||||||0.04
71069573|NCT03452488|141648462|SUPERIORITY|||||||0.2437|||||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic.||||0.2437
71069574|NCT03452488|141648462|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic||||0.2000
71069575|NCT03452488|141648462|SUPERIORITY|||||||0.324|TWO_SIDED|95.0|||||Adjusted Bayesian Imputation|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic based on adjusted Bayesian Imputation||||0.3240
71069576|NCT03452488|141648462|SUPERIORITY|Gait Speed Based on Adjusted Bayesian Imputation||||||0.5123|||||||Adjusted Bayesian Imputation|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic based on adjusted Bayesian Imputation||||0.5123
71069577|NCT03452488|141648462|SUPERIORITY|||||||0.692|||||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic based on MI and Adjusted Bayesian Imputation||||0.6920
71069578|NCT03452488|141648462|SUPERIORITY|||||||0.085|TWO_SIDED|95.0|||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic based on MI and Adjusted Bayesian Imputation||||0.0850
71069579|NCT03452488|141648463|SUPERIORITY|||||||0.9408|||||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Physical Function Domain (PF-10) Sub-score based on Mixed Model Analysis||||0.9408
70852806|NCT02744040|141194420|OTHER|Tukey's Honest Significant Difference (HSD) test|||||>|0.05||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in TILDA stimulation was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for TILDA Stimulation.||||>0.05
71069580|NCT03452488|141648463|SUPERIORITY|||||||0.9485|TWO_SIDED|95.0|||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Physical Function Domain (PF-10) Sub-score based on Mixed Model Analysis||||0.9485
71069581|NCT03452488|141648463|SUPERIORITY|||||||0.9848|||||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Physical Function Domain (PF-10) Sub-Score Based on Adjusted Bayesian Imputation||||0.9848
71069582|NCT03452488|141648463|SUPERIORITY|||||||0.5017|||||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Physical Function Domain (PF-10) Sub-Score Based on Adjusted Bayesian Imputation||||0.5017
71069583|NCT03452488|141648464|SUPERIORITY|||||||0.52|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test (dominant hand)||||0.5200
71069584|NCT03452488|141648464|SUPERIORITY|||||||0.3577|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test (dominant hand)||||0.3577
71069585|NCT03452488|141648464|SUPERIORITY|||||||0.9237|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test at Month 6 Based on Multiple Imputation (dominant hand)||||0.9237
71069586|NCT03452488|141648464|SUPERIORITY|||||||0.7629|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test at Month 6 Based on Multiple Imputation (dominant hand)||||0.7629
71069587|NCT03452488|141648464|SUPERIORITY|||||||0.5695|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Change from Baseline in Handgrip Strength Test (left hand)||||0.5695
71069588|NCT03452488|141648464|SUPERIORITY|||||||0.3523|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test (Left hand)||||0.3523
71069589|NCT03452488|141648464|SUPERIORITY|||||||0.5652|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test (Right hand)||||0.5652
71069590|NCT03452488|141648464|SUPERIORITY|||||||0.2472|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test (Right hand)||||0.2472
71069591|NCT03452488|141648465|SUPERIORITY|||||||0.9859||||||Statistical Analysis of Change from Baseline in ALM|ANCOVA|||||||0.9859
71069592|NCT03452488|141648465|SUPERIORITY|||||||0.404|||||||ANCOVA|||Statistical Analysis of Change from Baseline in ALM||||0.4040
71069593|NCT03452488|141648466|SUPERIORITY|||||||0.1219|||||||Regression, Logistic|||||||0.1219
71069594|NCT03452488|141648466|SUPERIORITY|||||||0.052|TWO_SIDED|95.0|||||Regression, Logistic|||||||0.0520
71069595|NCT03452488|141648467|SUPERIORITY|||||||0.8917|||||||ANCOVA|||||||0.8917
71069596|NCT03452488|141648467|SUPERIORITY||Mean Difference (Final Values)|-4.999|STANDARD_ERROR_OF_MEAN|10.2172||0.6317|TWO_SIDED|95.0|-26.777|16.778|||ANCOVA|||||16.778|-26.777|0.6317
71069597|NCT03452488|141648468|SUPERIORITY|||||||0.3762|||||||Mixed Models Analysis|||||||0.3762
71069598|NCT03452488|141648468|SUPERIORITY|||||||0.0543|||||||Mixed Models Analysis|||||||0.0543
71069599|NCT03452488|141648469|SUPERIORITY|||||||0.8824|||||||ANCOVA|||||||0.8824
71069600|NCT03452488|141648469|SUPERIORITY|||||||0.1578|||||||ANCOVA|||||||0.1578
71069601|NCT03452488|141648470|SUPERIORITY|||||||0.0511|||||||ANCOVA|||||||0.0511
71069602|NCT03452488|141648470|SUPERIORITY|||||||0.2771|||||||ANCOVA|||||||0.2771
71069603|NCT03452488|141648471|SUPERIORITY|||||||0.8084|||||||Mixed Models Analysis|||||||0.8084
71069604|NCT03452488|141648471|SUPERIORITY|||||||0.7266|||||||Mixed Models Analysis|||||||0.7266
71069605|NCT03452488|141648472|SUPERIORITY|||||||0.2312|||||||Mixed Models Analysis|||||||0.2312
71069606|NCT03452488|141648472|SUPERIORITY|||||||0.2701|||||||Mixed Models Analysis|||||||0.2701
71069607|NCT03452488|141648473|SUPERIORITY|||||||0.8934|||||||ANCOVA|||||||0.8934
71069608|NCT03452488|141648473|SUPERIORITY|||||||0.3526|||||||ANCOVA|||||||0.3526
71069609|NCT01945970|141648477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.36|TWO_SIDED|95.0|-1.09|0.4|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo|||0.40|-1.09|0.36
71069610|NCT01945970|141648478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.18|TWO_SIDED|95.0|-0.24|1.28|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo|||1.28|-0.24|0.18
71113259|NCT00904670|141734207|SUPERIORITY_OR_OTHER||LS mean difference|-2.66|STANDARD_ERROR_OF_MEAN|0.41|<|0.0001|TWO_SIDED|95.0|-3.5|-1.82|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.82|-3.50|<0.0001
71113260|NCT00904670|141734207|SUPERIORITY_OR_OTHER||LS mean difference|-2.95|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-3.77|-2.13|||ANOVA|||Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-2.13|-3.77|<0.0001
71069611|NCT01945970|141648479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89||||0.014|TWO_SIDED|95.0|-1.59|-0.19|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo|||-0.19|-1.59|0.014
71069612|NCT01945970|141648480|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.49||||0.22|TWO_SIDED|95.0|-1.3|0.31|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of positive control adjusted for placebo|||0.31|-1.30|0.22
71069613|NCT01945970|141648481|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.71||||0.09|TWO_SIDED|95.0|-0.11|1.53|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of positive control adjusted for placebo|||1.53|-0.11|0.09
71069614|NCT01945970|141648482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.32|TWO_SIDED|95.0|-1.13|0.37|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of positive control adjusted for placebo|||0.37|-1.13|0.32
71069615|NCT01945970|141648483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.89||||0.14|TWO_SIDED|95.0|-0.61|4.39|||Mixed Models Analysis|Subject as random factor and treatment and period as fixed effects.|Effect of black tea adjusted for placebo|||4.39|-0.61|0.14
71069616|NCT01945970|141648484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.69|TWO_SIDED|95.0|-2.41|1.62|||Mixed Models Analysis|Subject as random factor and treatment and period as fixed effects.|Effect of black tea adjusted for placebo|||1.62|-2.41|0.69
71069617|NCT01945970|141648485|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.44||||0.72|TWO_SIDED|95.0|-2.06|2.95|||Mixed Models Analysis|Subject as random factor and treatment and period as fixed effects|Effect of positive control adjusted for placebo|||2.95|-2.06|0.72
71069618|NCT01945970|141648486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86||||0.39|TWO_SIDED|95.0|-1.15|2.88|||Mixed Models Analysis|Subject as random factor and treatment and period as fixed effects|Effect of positive control adjusted for placebo|||2.88|-1.15|0.39
71069619|NCT01945970|141648487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.74|TWO_SIDED|95.0|-1.75|1.24|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo|||1.24|-1.75|0.74
71069620|NCT01945970|141648488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.41|TWO_SIDED|95.0|-2.12|0.88|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo|||0.88|-2.12|0.41
71069621|NCT01945970|141648489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.74|TWO_SIDED|95.0|-1.11|1.54|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects||1.54|-1.11|0.74
71069622|NCT01945970|141648490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.66|TWO_SIDED|95.0|-1.84|1.17|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of positive control adjusted for placebo|||1.17|-1.84|0.66
71069623|NCT01945970|141648491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.11|TWO_SIDED|95.0|-2.7|0.3|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of positive control adjusted for placebo|||0.30|-2.70|0.11
71069624|NCT01945970|141648492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.55|TWO_SIDED|95.0|-0.93|1.73|||Mixed Models Analysis||Effect of positive control adjusted for placebo|||1.73|-0.93|0.55
71069625|NCT00782184|141648493|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.4|||<|0.001|TWO_SIDED|95.0|3.4|21.0|||Regression, Logistic|||COMPARISON BETWEEN GROUPS FOR NUMBER OF PARTICIPANTS REACHING LDL-C GOAL OF \<70 MG/DL||21.0|3.4|<0.001
71069626|NCT00782184|141648494|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-15.0|||<|0.001|TWO_SIDED|95.0|-21.15|-8.84|||Longitudinal Data Analysis (LDA) Model|||||-8.84|-21.15|<0.001
71113261|NCT00904670|141734207|SUPERIORITY_OR_OTHER||LS mean difference|-2.49|STANDARD_ERROR_OF_MEAN|0.41|<|0.0001|TWO_SIDED|95.0|-3.33|-1.66|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.66|-3.33|<0.0001
71113262|NCT00904670|141734207|SUPERIORITY_OR_OTHER||LS mean difference|-1.26|STANDARD_ERROR_OF_MEAN|0.4||0.0035|TWO_SIDED|95.0|-2.07|-0.44|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.44|-2.07|0.0035
71113263|NCT00904670|141734207|SUPERIORITY_OR_OTHER||LS mean difference|-1.43|STANDARD_ERROR_OF_MEAN|0.53||0.0109|TWO_SIDED|95.0|-2.51|-0.35|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.35|-2.51|0.0109
71113264|NCT00904670|141734208|SUPERIORITY_OR_OTHER||LS mean difference|25.61|STANDARD_ERROR_OF_MEAN|4.61|<|0.0001|TWO_SIDED|95.0|16.26|34.96|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||34.96|16.26|<0.0001
71113265|NCT00904670|141734208|SUPERIORITY_OR_OTHER||LS mean difference|37.1|STANDARD_ERROR_OF_MEAN|5.21|<|0.0001|TWO_SIDED|95.0|26.54|47.66|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||47.66|26.54|<0.0001
71113266|NCT00904670|141734208|SUPERIORITY_OR_OTHER||LS mean difference|45.77|STANDARD_ERROR_OF_MEAN|7.35|<|0.0001|TWO_SIDED|95.0|30.89|60.65|||ANOVA|||Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||60.65|30.89|<0.0001
71069627|NCT00782184|141648495|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.7|||<|0.001|TWO_SIDED|95.0|3.3|13.9|||Regression, Logistic|||||13.9|3.3|<0.001
71069628|NCT00782184|141648496|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.5|||<|0.001|TWO_SIDED|95.0|2.0|6.0|||Regression, Logistic|||||6.0|2.0|<0.001
71113267|NCT00904670|141734208|SUPERIORITY_OR_OTHER||LS mean difference|35.46|STANDARD_ERROR_OF_MEAN|6.57|<|0.0001|TWO_SIDED|95.0|22.14|48.78|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||48.78|22.14|<0.0001
71069629|NCT00782184|141648497|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-8.24|||<|0.001|TWO_SIDED|95.0|-12.5|-3.97|||LDA Model|||||-3.97|-12.50|<0.001
71069630|NCT00782184|141648498|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|2.13||||0.593|TWO_SIDED|95.0|-5.67|9.93|||LDA Model|||||9.93|-5.67|0.593
71069631|NCT00782184|141648499|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|2.48||||0.211|TWO_SIDED|95.0|-1.41|6.37|||LDA Model|||||6.37|-1.41|0.211
71069632|NCT00782184|141648500|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-11.62|||<|0.001|TWO_SIDED|95.0|-17.32|-5.92|||LDA Model|||||-5.92|-17.32|<0.001
71069633|NCT00782184|141648501|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-16.1|||<|0.001|TWO_SIDED|95.0|-22.77|-9.44|||LDA Model|||||-9.44|-22.77|<0.001
71069634|NCT00782184|141648502|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-10.02|||<|0.001|TWO_SIDED|95.0|-14.96|-5.08|||LDA Model|||||-5.08|-14.96|<0.001
71069635|NCT00782184|141648503|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-13.21|||<|0.001|TWO_SIDED|95.0|-19.83|-6.59|||LDA Model|||||-6.59|-19.83|<0.001
71069636|NCT00782184|141648504|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-7.69||||0.002|TWO_SIDED|95.0|-12.5|-2.88|||LDA Model|||||-2.88|-12.50|0.002
71069637|NCT00782184|141648505|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|5.25|||<|0.001|TWO_SIDED|95.0|2.44|8.06|||LDA Model|||||8.06|2.44|<0.001
71069638|NCT00782184|141648506|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-12.91|||<|0.001|TWO_SIDED|95.0|-18.31|-7.52|||LDA Model|||||-7.52|-18.31|<0.001
70938949|NCT00657709|141378541|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for 44/76-SL strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.02|||||TWO_SIDED|95.0|0.93|1.13|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot3 for 44/76-SL strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||1.13|0.93|
71069639|NCT00782184|141648507|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|2.68||||0.785|TWO_SIDED|95.0|-16.5|21.86|||LDA Model|||||21.86|-16.50|0.785
71069640|NCT01551264|141648508|OTHER|P-value by chi-square comparing the Kaplan-Meier recurrence-free survival probability at 1.2 years post treatment with robust estimate of standard error due to the a priori assumption that data from bilateral limbs are correlated.||||||0.03|||||||Chi-squared|||||||0.03
71069641|NCT02572076|141648536|OTHER|Pilot study- no sample size was calculated|number of subjects with adequate cleansi|100.0|||||TWO_SIDED|95.0|66.0|100.0||||||patients had partial bowel preparation to mimic poor bowel cleansing before the colonoscopy procedure at baseline, MCS was used during the procedure to clean the colon.||100|66|
71069642|NCT01640379|141648542|SUPERIORITY||Odds Ratio (OR)|0.4||||0.07|TWO_SIDED|95.0|0.15|1.09||Judged by type one error limit alpha = 0.05.|t-test, 2 sided||The odds ratio is for the difference in chlamydia or gonorrhea (CT/GC) rates between arms at ninety days after intervention.|A comparison of Chlamydia or Gonorrhea positivity at 90 days post intervention.||1.09|0.15|0.070
71113268|NCT00904670|141734208|SUPERIORITY_OR_OTHER||LS mean difference|14.86|STANDARD_ERROR_OF_MEAN|5.86||0.0155|TWO_SIDED|95.0|3.0|26.73|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||26.73|3.00|0.0155
70852807|NCT02744040|141194420|OTHER|Tukey's Honest Significant Difference (HSD) test||||||0.052||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in TILDA stimulation was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for TILDA Stimulation.||||0.052
71069643|NCT01640379|141648542|SUPERIORITY||Odds Ratio (OR)|0.59||||0.043|TWO_SIDED|95.0|0.39|0.98||Judged by type one error limit alpha = 0.05.|generalized estimating equations||The odds ratio is for the difference in rate of change over time between arms, so is the difference in the odds increment for those receiving TECH N intervention versus the control group.|"We used generalized estimating equations to test for a difference in the trend of chlamydia or gonorrhea (CT/GC) rates over the study period.~The null hypothesis is that rates of CT/GC for women in the intervention arm were changing over the study period similarly to CT/GC rates in the control arm."||0.98|0.39|0.043
71069644|NCT01640379|141648543|SUPERIORITY||Odds Ratio (OR)|92.2|||<|0.001|TWO_SIDED|95.0|37.0|230.1|||Chi-squared|Adjusted for age, debut age, number of lifetime partners, baseline STI status (any vs none), insurance, and if woman had prior pregnancy.|Odds ratio is interpretable as the expected chance of having a 72 follow-up for intervention women compared to women in the control arm, given similar age, debut age, number of lifetime partners, baseline STI status, insurance, and pregnancy history.|H0: Women in TECHN arm had 72 hour visit with same frequency as women in control arm.||230.1|37.0|<0.001
71069645|NCT01640379|141648543|SUPERIORITY||Odds Ratio (OR)|0.6||||0.084|TWO_SIDED|95.0|0.36|1.05|||Regression, Logistic|Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance.|Odds ratio is for intervention arm relative to control.|H0: Women in TECHN arm reported complete adherence to medication regimen (yes or no) with same frequency as women in control arm.||1.05|0.36|0.084
71069646|NCT01640379|141648543|SUPERIORITY||Odds Ratio (OR)|0.9||||0.867|TWO_SIDED|95.0|0.36|2.34|||Regression, Logistic|Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance.|Odds ratio is for the chances of partner notification among TECH N recipients, relative to those in control arm.|H0: Women in TECHN arm notified their partners about their diagnoses more often than women in the control arm.||2.34|0.36|0.867
71069647|NCT01640379|141648543|SUPERIORITY||Odds Ratio (OR)|0.6||||0.153|TWO_SIDED|95.0|0.33|1.19|||Regression, Logistic|Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance.|Odds ratio is for partners of TECH-N recipients versus partners of women in control arm.|H0: Partners of women receiving the TECH-N intervention were treated more often than the partners of women in the control arm.||1.19|0.33|0.153
71069648|NCT01640379|141648543|SUPERIORITY||Odds Ratio (OR)|1.0||||0.351|TWO_SIDED|95.0|0.86|1.06|||Regression, Logistic|Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance.|Odds ratio is for women in the TECH-N arm relative to women in the control arm.|H0: Women in the TECHN arm practiced temporary sexual abstinence for two weeks after their diagnosis more often than those in the control arm.||1.06|0.86|0.351
71069649|NCT03395184|141648544|OTHER||Percentage risk difference|14.3||||0.0119|TWO_SIDED|90.0|4.0|24.5|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum (min) risk weight method (Mehrotra-Railkar 2000)|||24.5|4.0|0.0119
71069650|NCT03395184|141648544|OTHER||Percentage risk difference|21.4||||0.0012|TWO_SIDED|90.0|10.0|32.9|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||32.9|10.0|0.0012
71069651|NCT03395184|141648558|OTHER||Percentage risk difference|13.3||||0.039|TWO_SIDED|90.0|1.0|25.7|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||25.7|1.0|0.0390
70938950|NCT00657709|141378541|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for 44/76-SL strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.14|||||TWO_SIDED|95.0|1.03|1.27|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot2 to rMenB Lot3 for 44/76-SL strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||1.27|1.03|
70938951|NCT00657709|141378541|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for 5/99 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.88|||||TWO_SIDED|95.0|0.78|0.98|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot2 for 5/99 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||0.98|0.78|
70938952|NCT00657709|141378541|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for 5/99 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.99|||||TWO_SIDED|95.0|0.88|1.1|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot3 for 5/99 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||1.1|0.88|
70938953|NCT00657709|141378541|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for 5/99 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.12|||||TWO_SIDED|95.0|1.0|1.26|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot2 to rMenB Lot3 for 5/99 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||1.26|1.0|
71069652|NCT03395184|141648558|OTHER||Percentage risk difference|29.7||||0.0001|TWO_SIDED|90.0|17.2|42.2|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||42.2|17.2|0.0001
71069653|NCT03395184|141648559|OTHER||LS mean difference|-3.0||||0.0007|TWO_SIDED|90.0|-4.55|-1.48|||ANCOVA|The ANCOVA model included treatment and baseline disease activity/extent as factors, and baseline SES-CD score as a covariate.||||-1.48|-4.55|0.0007
71069654|NCT03395184|141648559|OTHER||LS mean difference|-4.9|||<|0.0001|TWO_SIDED|90.0|-6.62|-3.26|||ANCOVA|The ANCOVA model included treatment and baseline disease activity/extent as factors, and baseline SES-CD score as a covariate.||||-3.26|-6.62|<.0001
71069655|NCT03395184|141648560|OTHER||Percentage risk difference|13.9||||0.0279|TWO_SIDED|90.0|2.1|25.6|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using using minimum risk weight method (Mehrotra-Railkar, 2000).|||25.6|2.1|0.0279
71069656|NCT03395184|141648560|OTHER||Percentage risk difference|31.5|||<|0.0001|TWO_SIDED|90.0|19.1|43.9|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||43.9|19.1|<.0001
71069657|NCT03395184|141648561|OTHER||Percentage risk difference|2.5||||0.2922|TWO_SIDED|90.0|-4.3|9.3|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||9.3|-4.3|0.2922
71069658|NCT03395184|141648561|OTHER||Percentage risk difference|7.4||||0.0449|TWO_SIDED|90.0|-0.4|15.2|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||15.2|-0.4|0.0449
71069659|NCT03395184|141648562|OTHER||Percentage risk difference|5.8||||0.0998|TWO_SIDED|90.0|-1.6|13.3|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||13.3|-1.6|0.0998
71069660|NCT03395184|141648562|OTHER||Percentage risk difference|11.8||||0.0111|TWO_SIDED|90.0|2.8|20.9|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||20.9|2.8|0.0111
71069661|NCT00784550|141648580|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71069662|NCT00784550|141648581|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71069663|NCT00784550|141648582|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANCOVA|||||||0.006
71069664|NCT00784550|141648583|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71069665|NCT00784550|141648584|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71069666|NCT00784550|141648585|SUPERIORITY_OR_OTHER|||||||0.069||95.0||||Mastery domain|ANCOVA|||||||0.069
70938954|NCT00657709|141378541|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for for NZ98/254 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.04||||||95.0|0.88|1.23|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot2 for NZ98/254 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||1.23|0.88|
70938955|NCT00657709|141378541|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for for NZ98/254 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.96||||||95.0|0.81|1.13|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot3 for NZ98/254 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||1.13|0.81|
70938956|NCT00657709|141378541|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for for NZ98 /254 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.92|||||TWO_SIDED|95.0|0.78|1.08|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||"The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot2 to rMenB Lot3 for NZ98~/254 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0)."||1.08|0.78|
70938957|NCT00657709|141378543|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for 44/76-SL strain.|Vaccines Group Differences|0.0|||||TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at one month after the third vaccination, were entirely within the interval \[-10%, 10%\].||1|-1|
70938958|NCT00657709|141378543|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for 44/76-SL strain.|Vaccines Group Differences|1.0|||||TWO_SIDED|95.0|0.0|2.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval \[-10%, 10%\].||2|0|
70938959|NCT00657709|141378543|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for 44/76-SL strain.|Vaccines Group Differences|1.0|||||TWO_SIDED|95.0|0.0|2.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval \[-10%, 10%\].||2|0|
71069667|NCT00784550|141648585|SUPERIORITY_OR_OTHER|||||||0.47||95.0||||Fatigue domain|ANCOVA|||||||0.470
71069668|NCT00784550|141648585|SUPERIORITY_OR_OTHER|||||||0.394||95.0||||Emotional function domain|ANCOVA|||||||0.394
71069669|NCT00784550|141648585|SUPERIORITY_OR_OTHER|||||||0.879||95.0|||||ANCOVA|Dyspnea domain||||||0.879
71069670|NCT00688701|141648586|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.123|<|0.0001|TWO_SIDED|95.0|-0.785|-0.3||Stepwise testing procedure applied to control type 1 error: Lixisenatide (2-step titration) was compared with Placebo (combined), if found statistically significant, then Lixisenatide (1-step titration) arm compared with Placebo (combined).|ANCOVA|||"To detect a difference of 0.5% in change in HbA1c at Week 12 between 1 lixisenatide arm and placebo (combined), 120 patients per group would provide a power of 90% assuming common standard deviation of 1.2% with 2-sided test at 5% significance level.~Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0,\>=8.0%), BMI (\<30,\>=30 kg/m\^2), country as fixed effects, baseline HbA1c as covariate."||-0.300|-0.785|<0.0001
71069671|NCT00688701|141648586|SUPERIORITY_OR_OTHER||LS mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.122|<|0.0001|TWO_SIDED|95.0|-0.903|-0.423||Stepwise testing procedure applied to control type 1 error: Lixisenatide (2-step titration) was compared with Placebo (combined), if found statistically significant, then Lixisenatide (1-step titration) arm compared with Placebo (combined).|ANCOVA|||"To detect a difference of 0.5% in change in HbA1c at Week 12 between 1 lixisenatide arm and placebo (combined), 120 patients per group would provide a power of 90% assuming common standard deviation of 1.2% with 2-sided test at 5% significance level.~Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0,\>=8.0%), BMI (\<30,\>=30 kg/m\^2), country as fixed effects, baseline HbA1c as covariate."||-0.423|-0.903|<0.0001
71069672|NCT03875092|141648600|OTHER||Hazard Ratio (HR)|0.35|||||TWO_SIDED|95.0|0.24|0.52|||||Based on unstratified Cox regression model with treatment as a covariate, due to small sample size.|||0.52|0.24|
71079345|NCT00424593|141666197|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value for Change from Baseline.|ANOVA|ANOVA based on rank transformation.||||||0.008
71113269|NCT00904670|141734208|SUPERIORITY_OR_OTHER||LS mean difference|20.69|STANDARD_ERROR_OF_MEAN|6.18||0.0019|TWO_SIDED|95.0|8.17|33.22|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||33.22|8.17|0.0019
71113270|NCT00904670|141734210|SUPERIORITY_OR_OTHER||LS mean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.52||0.0014|TWO_SIDED|95.0|-2.85|-0.74|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.74|-2.85|0.0014
71113271|NCT00904670|141734210|SUPERIORITY_OR_OTHER||LS mean difference|-2.79|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-3.76|-1.82|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.82|-3.76|<0.0001
71113272|NCT00904670|141734210|SUPERIORITY_OR_OTHER||LS mean difference|-3.89|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|-5.12|-2.67|||ANOVA|||Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-2.67|-5.12|<0.0001
71113273|NCT00904670|141734210|SUPERIORITY_OR_OTHER||LS mean difference|-2.65|STANDARD_ERROR_OF_MEAN|0.65||0.0002|TWO_SIDED|95.0|-3.97|-1.33|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.33|-3.97|0.0002
71113274|NCT00904670|141734210|SUPERIORITY_OR_OTHER||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.45||0.3492|TWO_SIDED|95.0|-1.34|0.49|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||0.49|-1.34|0.3492
71113275|NCT00904670|141734210|SUPERIORITY_OR_OTHER||LS mean difference|-1.34|STANDARD_ERROR_OF_MEAN|0.5||0.0105|TWO_SIDED|95.0|-2.34|-0.33|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.33|-2.34|0.0105
71113276|NCT00904670|141734211|SUPERIORITY_OR_OTHER||LS mean difference|-1.72|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.43|-1.0|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.00|-2.43|<0.0001
71069673|NCT03875092|141648601|OTHER||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.28|0.7|||||Based on unstratified Cox regression model with treatment as a covariate, due to small sample size.|||0.70|0.28|
71069674|NCT03875092|141648602|OTHER||Difference in Percentage|36.7|||||TWO_SIDED|95.0|19.9|51.6|||||Based on unstratified Miettinen \& Nurminen method, due to small sample size.|||51.6|19.9|
71069675|NCT02759055|141648620|SUPERIORITY||Risk Ratio (RR)|1.003|||<|0.05|TWO_SIDED|95.0|0.998|1.008|||Mixed Models Analysis|||||1.008|0.998|<0.05
71069676|NCT00614523|141648632|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.83||||0.13|TWO_SIDED|95.0|0.66|1.05|||Anderson-Gill model|Anderson-Gill model using the model-based variance estimate and stratified by the randomization stratification factors|Romiplostim /Placebo|||1.05|0.66|0.13
71069677|NCT00614523|141648633|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.766|||<|0.001|TWO_SIDED|95.0|0.66|0.88|||Poisson regression model|Poisson regression model with treatment and stratification factors as covariates.|Romiplostim /Placebo|||0.88|0.66|<0.001
71069678|NCT00614523|141648634|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.922||||0.026|TWO_SIDED|95.0|0.86|0.99|||Poisson regression model|Poisson regression model with treatment and stratification factors as covariates.|Romiplostim /Placebo|||0.99|0.86|0.026
71069679|NCT00614523|141648635|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.739|||<|0.001|TWO_SIDED|95.0|0.68|0.8|||Poisson Regression model|Poisson regression model with treatment and stratification factors as covariates|Romiplostim /Placebo|||0.8|0.68|<0.001
71069680|NCT00614523|141648636|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|15.6|||<|0.001|TWO_SIDED|95.0|4.7|51.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for stratification factors.|Romiplostim /Placebo|||51.8|4.7|<0.001
71069681|NCT00614523|141648637|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.402||||0.032|TWO_SIDED|95.0|1.03|1.91|||Poisson regression model|Poisson regression model with treatment and stratification factors as covariates|Romiplostim /Placebo|||1.91|1.03|0.032
71069682|NCT00614523|141648641|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.639|||<|0.001|TWO_SIDED|95.0|0.57|0.71|||Poisson regression model|Poisson regression model with treatment and stratification factors as covariates|Romiplostim /Placebo|||0.71|0.57|<0.001
71069683|NCT03692325|141648643|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
71069684|NCT02461524|141648650|OTHER||Percentage|2.9|||<|0.001|ONE_SIDED|97.5||8.7|||Exact binomial test|||"The primary safety endpoint was tested against a predetermined safety Performance Goal (PG) using the following statistical hypotheses:~H0: p ≥ 20% vs. H1: p \< 20% where p is the proportion of subjects experiencing a Major Adverse Event (MAE) within 30 days of the index procedure in the target population of subjects treated with the Endurant Evo Abdominal Aortic Aneurysm (AAA) Stent graft system and 20% is the safety PG."||8.7||<0.001
71069685|NCT02461524|141648651|OTHER|Single-arm study with a hypothesis test comparing to performance goal|Percentage|100.0||||0.001|ONE_SIDED|95.0|95.8||||Based on exact binomial distribution|||"The primary effectiveness endpoint was tested against a predetermined effectiveness PG using following statistical hypotheses:~H0: q ≤ 80% vs. H1: q \> 80% where q is the proportion of subjects who have a successful aneurysm treatment in the target population of subjects treated with the Endurant Evo AAA Stent graft system and 80% is the effectiveness PG."|||95.8|0.001
71069686|NCT00765895|141648672|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86|||||||Mantel Haenszel|Stratified by clinic||||||0.86
71069687|NCT04481191|141648674|NON_INFERIORITY|Non-inferiority was declared when the lower bound of the 95% CI for the difference in percentages (Concomitant-use Group - Staggered-use Group) being \> -10 percentage points (one-sided p-value \< 0.025).|Mean Difference (Final Values)|-1.1|||<|0.001|TWO_SIDED|95.0|-4.0|0.9||One-sided p-value|Unstratified Miettinen & Nurminen method|||Difference indicates Concomitant-use Group % - Staggered-use Group %||0.9|-4.0|< 0.001
71069688|NCT04481191|141648674|NON_INFERIORITY|Non-inferiority was declared when the lower bound of the 95% CI for the difference in percentages (Concomitant-use Group - Staggered-use Group) being \> -10 percentage points (one-sided p-value \< 0.025).|Mean Difference (Final Values)|-1.1|||<|0.001|TWO_SIDED|95.0|-4.3|1.5||One-sided p-value|Unstratified Miettinen & Nurminen method|||Difference indicates Concomitant-use Group % - Staggered-use Group %||1.5|-4.3|< 0.001
71069689|NCT04481191|141648674|NON_INFERIORITY|Non-inferiority was declared when the lower bound of the 95% CI for the difference in percentages (Concomitant-use Group - Staggered-use Group) being \> -10 percentage points (one-sided p-value \< 0.025).|Mean Difference (Final Values)|0.5|||<|0.001|TWO_SIDED|95.0|-1.6|3.0||One-sided p-value|Unstratified Miettinen & Nurminen method|||Difference indicates Concomitant-use % - Staggered-use %||3.0|-1.6|< 0.001
71069690|NCT02002533|141648754|SUPERIORITY||||||>|0.9999|||||||exact binomial test|The percentage is greater than or equal to 40%.||||||>0.9999
71069691|NCT02002533|141648755|SUPERIORITY|||||||0.735|||||||exact binomial test|||||||0.7350
71069692|NCT02002533|141648756|SUPERIORITY||Mean Difference (Final Values)|0.8075|STANDARD_ERROR_OF_MEAN|0.0845|<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
71069693|NCT02002533|141648757|SUPERIORITY||Mean Difference (Final Values)|-1.64|STANDARD_ERROR_OF_MEAN|1.21||0.1808|TWO_SIDED||||||ANCOVA||The estimated value is BBT minus HEAL.|||||0.1808
71069694|NCT02002533|141648758|SUPERIORITY||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|0.73||0.14|TWO_SIDED||||||ANCOVA||Estimated value is BBT minus HEAL.|||||0.14
71069695|NCT02002533|141648759|SUPERIORITY||Mean Difference (Final Values)|0.404|STANDARD_ERROR_OF_MEAN|0.137||0.005|TWO_SIDED||||||ANCOVA|For baseline of 0.7.||||||0.005
71069696|NCT02002533|141648759|SUPERIORITY||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.045||0.092|TWO_SIDED|||||At baseline 1.3.|ANCOVA|||||||0.092
71069697|NCT02002533|141648759|SUPERIORITY||Mean Difference (Final Values)|-0.032|STANDARD_ERROR_OF_MEAN|0.053||0.556|TWO_SIDED|||||At baseline of 1.5.|ANCOVA|||||||0.556
71069698|NCT02002533|141648759|SUPERIORITY||Mean Difference (Final Values)|-6.24|STANDARD_ERROR_OF_MEAN|0.221||0.007|TWO_SIDED|||||Grouped by baseline interaction.|ANCOVA||The estimated value is grouped by baseline interaction parameter.|||||0.007
71069699|NCT02002533|141648760|SUPERIORITY|||||||0|||||||ANCOVA|||||||0.000
71069700|NCT02002533|141648761|SUPERIORITY|||||||0.295|||||||ANCOVA|||||||0.295
71069701|NCT02002533|141648762|SUPERIORITY|||||||0.573|||||||ANCOVA|||||||0.573
71069702|NCT02002533|141648763|SUPERIORITY||Mean Difference (Final Values)|-6.502|STANDARD_ERROR_OF_MEAN|2.558||0.015|TWO_SIDED||||||ANCOVA||Group difference (BBT - HEAL) in mean post-pre change.|||||0.015
71069703|NCT02002533|141648763|SUPERIORITY||Mean Difference (Final Values)|-1.723|STANDARD_ERROR_OF_MEAN|1.007||0.094|TWO_SIDED||||||ANCOVA||Group difference (BBT - HEAL) in mean post-pre change.|||||0.094
71069704|NCT02002533|141648763|SUPERIORITY||Mean Difference (Final Values)|3.75|STANDARD_ERROR_OF_MEAN|2.326||0.114|TWO_SIDED||||||ANCOVA||Group difference (BBT - HEAL) in mean post-pre change.|||||0.114
71069705|NCT02002533|141648763|SUPERIORITY||Mean Difference (Final Values)|0.911|STANDARD_ERROR_OF_MEAN|0.4||0.027|TWO_SIDED||||||ANCOVA||This is an arm by baseline interaction parameter.|||||0.027
71069706|NCT00722566|141648768|NON_INFERIORITY_OR_EQUIVALENCE|Assuming ORRs are 35.5% for both SC and IV, one-sided alpha level of 0.025, and approximately 80% power, approximately 216 subjects (144 SC:72 IV) are needed to show non-inferiority of SC to IV VELCADE.|ORR_SQ - 0.6 ORR_IV|16.8||||0.00201|TWO_SIDED|95.0|6.1|27.1|||Farrrington and Manning|CONOR P. FARRINGTON AND GODFREY MANNING STATISTICS IN MEDICINE, VOL. 9, 1447-1454(1990).||In this trial, non-inferiority is defined as retaining 60% of the IV (active control) treatment effect as measured by ORR. The non-inferiority hypothesis can be stated as: H0: ORRSC - 0.60 ORRIV \<0 vs. H1: ORRSC - 0.60 ORRIV ≥0 (non-inferiority).||27.1|6.1|0.00201
71069707|NCT04984278|141648770|SUPERIORITY||Combined least mean square difference|-0.29|STANDARD_ERROR_OF_MEAN|0.092|=|0.0048|TWO_SIDED|95.0|-0.48|-0.1|||Mixed Models Analysis|||||-0.10|-0.48|=0.0048
71069708|NCT00425061|141648789|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-5.2||||0.612|TWO_SIDED|95.0|-25.6|15.2|||ANCOVA|||Day 112: Analysis of co-variance (ANCOVA) model was used with baseline as a covariate, long-acting beta-agonist (LABA) use (Inhaled Corticosteroid \[ICS\] only or ICS plus LABA) and treatment as two factors.||15.2|-25.6|0.612
71069709|NCT00425061|141648791|SUPERIORITY_OR_OTHER||LS mean Difference|0.0||||0.482|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Day 8: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.1|-0.2|0.482
71069710|NCT00425061|141648791|SUPERIORITY_OR_OTHER||LS mean difference|0.0||||0.492|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Day 28: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.1|-0.2|0.492
71069711|NCT00425061|141648791|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.323|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Day 56: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.1|-0.2|0.323
71069712|NCT00425061|141648791|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.226|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Day 84: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.1|-0.2|0.226
71069713|NCT00425061|141648791|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.256|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Day 112: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.1|-0.2|0.256
71069714|NCT00425061|141648792|SUPERIORITY_OR_OTHER||LS mean difference|1.8||||0.09|TWO_SIDED|95.0|-0.3|3.9|||ANCOVA|||Day 28: ANCOVA model was based on the log 2 transformed methacholine challenge test values with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||3.9|-0.3|0.090
71069715|NCT00425061|141648792|SUPERIORITY_OR_OTHER||LS mean difference|2.1||||0.144|TWO_SIDED|95.0|-0.8|5.0|||ANCOVA|||Day 112: ANCOVA model was based on the log 2 transformed methacholine challenge test values with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||5.0|-0.8|0.144
71069716|NCT00425061|141648794|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.354|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||Day 8: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.1|-0.4|0.354
71069717|NCT00425061|141648794|SUPERIORITY_OR_OTHER||LS mean difference|0.0||||0.9|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Day 28: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.4|-0.4|0.900
71069718|NCT00425061|141648794|SUPERIORITY_OR_OTHER||LS mean difference|0.0||||0.921|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Day 56: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.4|-0.4|0.921
71069719|NCT00425061|141648794|SUPERIORITY_OR_OTHER||LS mean difference|0.2||||0.388|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Day 84: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.6|-0.2|0.388
71069720|NCT00425061|141648794|SUPERIORITY_OR_OTHER||LS mean difference|0.2||||0.249|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Day 112: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.7|-0.2|0.249
71069721|NCT00425061|141648795|SUPERIORITY_OR_OTHER|||||||0.267|TWO_SIDED||||||Chi-squared|||||||0.267
71069722|NCT00425061|141648796|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Chi-squared|||||||0.029
71069723|NCT02651155|141648839|SUPERIORITY_OR_OTHER||Median Values of CI|1.0||||0.003|TWO_SIDED|95.0|0.1|1.0|||Van Elteren Test|SBM was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|CI was estimated by inverting the hypothesis test.|||1.0|0.1|0.003
71069724|NCT05875025|141648874|OTHER||Adjusted mean difference|1.36||||0.442|TWO_SIDED|95.0|-2.28|4.99|||ANCOVA|Analysis of covariance (ANCOVA) model, included treatment, subject, and period as fixed effects; PPR2 at baseline as a covariate.||||4.99|-2.28|0.442
71069725|NCT05875025|141648875|OTHER||Adjusted mean difference|0.7||||0.553|TWO_SIDED|95.0|-1.73|3.12|||ANCOVA|Analysis of covariance (ANCOVA) model, included treatment, subject, and period as fixed effects; PPR4 at baseline as a covariate.||||3.12|-1.73|0.553
71069726|NCT01489254|141648877|NON_INFERIORITY_OR_EQUIVALENCE|To conclude study sensitivity the combined active treatment groups Glatiramer 20 mg and Copaxone 20 mg needed to be superior to placebo.|Ratio (or Ratio of estimated means)|0.488|||||TWO_SIDED|95.0|0.365|0.651|||||Ratio of combined Glatiramer 20 mg + Copaxone 20 mg to placebo and 95% confidence interval.|Estimates represent the mean total lesions during months 7 through 9 and were estimated from the fitted random effect generalized linear model (longitudinal model) with a negative binomial distribution and logaritmic link function. To assess study sensitivity, data of the active treatment groups and placebo were included in the model, resulting in the ratios and 95% CIs for the combined Glatiramer 20 mg and Copaxone 20 mg treatment group and the individual treatments over placebo.||0.651|0.365|
71069727|NCT01489254|141648877|NON_INFERIORITY_OR_EQUIVALENCE|To conclude equivalence between Glatiramer 20 mg and Copaxone 20 mg, efficacy in the combined active treatment groups needed to be superior to placebo (confirming study sensitivity) and the 2-sided 95% CI for the estimated ratio of Glatiramer 20 mg to Copaxone 20 mg needed to be fully enclosed in the prespecified equivalence margin (0.727 - 1.375).|Ratio (or Ratio of estimated means)|1.095|||||TWO_SIDED|95.0|0.883|1.36|||||Ratio of Glatiramer 20 mg to Copaxone 20 mg and 95% confidence interval.|Estimates represent the mean total lesions during months 7 through 9 and were estimated from the fitted random effect generalized linear model (longitudinal model) with a negative binomial distribution and logaritmic link function including Glatiramer 20 mg and Copaxone 20 mg treatment groups to assess study equivalence.||1.360|0.883|
71069728|NCT01023256|141648895|SUPERIORITY_OR_OTHER|||||||0.095||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.||||||0.095
71069729|NCT01023256|141648895|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.||||||<0.0001
71069730|NCT01023256|141648895|SUPERIORITY_OR_OTHER|||||||0.003||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.||||||0.003
71069731|NCT01023256|141648897|SUPERIORITY_OR_OTHER|||||||0.421||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.||||||0.421
71079346|NCT00424593|141666198|SUPERIORITY_OR_OTHER|||||||0.028||95.0||||P-value for Week 13 Change from Baseline.|ANOVA|||||||0.028
71079347|NCT00424593|141666199|SUPERIORITY_OR_OTHER|||||||0.764||95.0||||P-value for SBP Week 13 Change from Baseline.|ANOVA|||||||0.764
71069732|NCT01023256|141648897|SUPERIORITY_OR_OTHER|||||||0.003||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.||||||0.003
71069733|NCT01023256|141648897|SUPERIORITY_OR_OTHER|||||||0.065||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.||||||0.065
71069734|NCT01023256|141648898|SUPERIORITY_OR_OTHER|||||||0.243||||||P values \<0.05 were considered to be statistically significant.|Fisher Exact|Patients with missing values were not included||||||0.243
71069735|NCT01023256|141648898|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P values \< 0.05 were considered significant.|Fisher Exact|Patients with missing values were not included||||||<0.0001
71069736|NCT01023256|141648898|SUPERIORITY_OR_OTHER|||||||0.135||||||P values \<0.05 were considered to be statistically significant.|Fisher Exact|Patients with missing values were not included.||||||0.135
71069737|NCT03155178|141648902|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.15||0.13|TWO_SIDED|95.0|-0.53|0.07|||Paired t-test|||"48-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 48-hours post-treatment."||0.07|-0.53|0.13
71079348|NCT00424593|141666199|SUPERIORITY_OR_OTHER|||||||0.093||95.0||||P-value for DBP Week 13 Change from Baseline.|ANOVA|||||||0.093
71079349|NCT00424593|141666200|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value for Week 13 Change from Baseline.|ANOVA|||||||0.008
71079350|NCT02131233|141666284|NON_INFERIORITY_OR_EQUIVALENCE|Reformulated Raltegravir is concluded non-inferior to Raltegravir if the lower bound of the 95% CI for the difference in percent response is above -10 percentage points.|Estimated Difference|0.51|||||TWO_SIDED|95.0|-4.204|5.223|||||Reformulated Raltegravir minus Raltegravir|The 95% Confidence Interval (CI) for the treatment differences in percent response were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA \<=100,000 copies/mL or HIV-1 RNA \>100,000 copies/mL)||5.223|-4.204|
71079351|NCT02131233|141666285|NON_INFERIORITY_OR_EQUIVALENCE|Reformulated Raltegravir is concluded non-inferior to Raltegravir if the lower bound of the 95% CI for the difference in percent response is above -10 percentage points.|Estimated Difference|1.449|||||TWO_SIDED|95.0|-4.41|7.308|||||Reformulated Raltegravir minus Raltegravir|The 95% Confidence Interval (CI) for the treatment differences in percent response were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA \<=100,000 copies/mL or HIV-1 RNA \>100,000 copies/mL)||7.308|-4.410|
71079352|NCT02131233|141666286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1|||||TWO_SIDED|95.0|-30.9|26.7|||||Reformulated Raltegravir minus Raltegravir|The 95% CI for mean difference in CD4 change was based on t-distribution.||26.7|-30.9|
71079353|NCT02131233|141666287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-32.8|31.6|||||Reformulated Raltegravir minus Raltegravir|The 95% CI for mean difference in CD4 change was based on t-distribution.||31.6|-32.8|
71079354|NCT01537835|141666317|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|||||p-value is adjusted for multiple comparisons|Kruskal-Wallis|||||||0.17
71079355|NCT01462305|141666333|SUPERIORITY_OR_OTHER|||||||0.74||||||interaction effect and week of treatment condition|ANOVA|||To test the hypothesis that depressed SAD patients would demonstrate greater antidepressant therapeutic benefit from the \~465nm (shorter wavelength) source compared with the \~595nm (longer wavelength) source, we conducted a repeated-measures ANOVA using PROC MIXED in SAS 9.3 with treatment (\~465nm vs. \~595nm) as a between-subject factor and time (treatment visit 1, treatment visit 2, treatment visit 3, phone assessment 1, phone assessment 2, and treatment visit 4) as a within-subject factor.||||0.74
71079356|NCT01462305|141666333|SUPERIORITY_OR_OTHER|||||||0.9||||||A repeated-measures ANOVA on the 29 subjects revealed no significant effect or interaction effect|ANOVA|||||||0.9
71079357|NCT01462305|141666333|SUPERIORITY_OR_OTHER||||||<|0.0001||||||A repeated-measures ANOVA on the 29 subjects revealed significant effect of treatment week|ANOVA|||||||<0.0001
71079358|NCT01462305|141666335|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||ANOVA|||||||0.20
71079359|NCT00368459|141666344|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||For this pilot trial, we did not anticipate power to detect significant, clinically-meaningful between-group differences of the magnitude provided by FDA-approved AD therapies over a 12 month treatment period, but we specified that we would report trends (alpha \<0.1) as a guide to future effectiveness studies.||||>0.1
71079360|NCT00368459|141666345|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
71079361|NCT00368459|141666346|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
71079362|NCT00368459|141666347|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
71079363|NCT00368459|141666348|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
71079364|NCT00368459|141666349|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
71079365|NCT00368459|141666350|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
71079366|NCT00368459|141666351|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Favoring placebo, unadjusted for multiple comparisons|ANCOVA|||||||<0.01
71079367|NCT00368459|141666352|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
71079368|NCT00368459|141666353|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
71069738|NCT03155178|141648902|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.13||0.78|TWO_SIDED|95.0|-0.23|0.3|||Paired t-test|||"72-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 72-hours post-treatment."||0.30|-0.23|0.78
71069739|NCT03155178|141648902|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.17||0.77|TWO_SIDED|95.0|-0.38|0.29|||Paired t-test|||"96-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 96-hours post-treatment."||0.29|-0.38|0.77
71069740|NCT03155178|141648902|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.15||0.37|TWO_SIDED|95.0|-0.45|0.17|||Paired t-test|||"48-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 48-hours post-treatment."||0.17|-0.45|0.37
71069741|NCT03155178|141648902|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.2||0.33|TWO_SIDED|95.0|-0.2|0.58|||Paired t-test|||"72-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 72-hours post-treatment."||0.58|-0.20|0.33
71069742|NCT03155178|141648902|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.16||0.65|TWO_SIDED|95.0|-0.25|0.39|||Paired t-test|||"96-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 96-hours post-treatment."||0.39|-0.25|0.65
71069743|NCT03155178|141648903|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.22||0.38|TWO_SIDED|95.0|-0.63|0.24|||Paired t-test|||"48-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 48-hours post-treatment."||0.24|-0.63|0.38
71069744|NCT03155178|141648903|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.19||0.68|TWO_SIDED|95.0|-0.3|0.45|||Paired t-test|||"72-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 72-hours post-treatment."||0.45|-0.30|0.68
71069745|NCT03155178|141648903|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.23||0.97|TWO_SIDED|95.0|-0.47|0.45|||Paired t-test|||"96-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 96-hours post-treatment."||0.45|-0.47|0.97
71069746|NCT03155178|141648903|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.23||0.4|TWO_SIDED|95.0|-0.27|0.65|||Paired t-test|||"48-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 48-hours post-treatment."||0.65|-0.27|0.40
71069747|NCT03155178|141648903|SUPERIORITY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|0.25||0.03|TWO_SIDED|95.0|0.05|1.03||Using a Hochberg Step-up procedure the critical p value is 0.17|Paired t-test|||"72-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 72-hours post-treatment."||1.03|0.05|0.03
71069748|NCT03155178|141648903|SUPERIORITY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.23||0.07|TWO_SIDED|95.0|-0.03|0.87|||Paired t-test|||"96-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 96-hours post-treatment."||0.87|-0.03|0.07
71069749|NCT03613649|141648909|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern. Statistically, the test of prolongation is equivalent to a non-inferiority test versus placebo by crossover design, with an non-inferiority margin of 10 ms.|Least-Squares Mean Double Delta Value|-0.99|||||ONE_SIDED|95.0||0.635||||||"Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 0.5 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).~Power Calculation:~Enrollment of 72 subjects would provide at least 84% power to conclude a negative effect, given that up to 16 subjects may withdraw early prior to beginning to replace subjects (at least 56 subjects evaluable), and assuming a standard deviation of ΔΔQTcF of 7 msec and an underlying effect of 5 msec."||0.635||
71079369|NCT02087943|141666391|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-15.01||||0.1308|TWO_SIDED|95.0|-34.52|4.5||Based on an analysis of covariance model with the percentage change from baseline as the response variable and the treatment group and Baseline EASI score stratification (≤ 20, \> 20) as factors.|ANCOVA|||||4.50|-34.52|0.1308
71069750|NCT03613649|141648909|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|0.59|||||ONE_SIDED|95.0||2.2||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 1 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||2.200||
71113277|NCT00904670|141734211|SUPERIORITY_OR_OTHER||LS mean difference|-2.94|STANDARD_ERROR_OF_MEAN|0.41|<|0.0001|TWO_SIDED|95.0|-3.78|-2.1|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-2.10|-3.78|<0.0001
71113278|NCT00904670|141734211|SUPERIORITY_OR_OTHER||LS mean difference|-3.34|STANDARD_ERROR_OF_MEAN|0.38|<|0.0001|TWO_SIDED|95.0|-4.11|-2.57|||ANOVA|||Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-2.57|-4.11|<0.0001
71113279|NCT00904670|141734211|SUPERIORITY_OR_OTHER||LS mean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.46|<|0.0001|TWO_SIDED|95.0|-3.64|-1.76|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.76|-3.64|<0.0001
71113280|NCT00904670|141734211|SUPERIORITY_OR_OTHER||LS mean difference|-1.57|STANDARD_ERROR_OF_MEAN|0.41||0.0006|TWO_SIDED|95.0|-2.4|-0.73|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.73|-2.40|0.0006
71113281|NCT00904670|141734211|SUPERIORITY_OR_OTHER||LS mean difference|-1.12|STANDARD_ERROR_OF_MEAN|0.4||0.0087|TWO_SIDED|95.0|-1.94|-0.3|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.30|-1.94|0.0087
71113282|NCT00286091|141734212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.0284|TWO_SIDED|95.0|0.73|0.98|||Wald test||Based on the Cox proportional hazards model stratified by PSA ≥ 8.0 ng/mL, PSA doubling time ≤ 10 months and previous or current chemotherapy for prostate cancer. A hazard ratio \< 1 favors denosumab.|Primary and secondary endpoint analyses were conducted hierarchically. To preserve an overall type I error rate of 0.05, a 0.0488 2-sided test of bone metastasis-free survival was performed. If superiority of denosumab over placebo was established, time to first bone metastasis was tested with a 2-sided significance level of 0.050. If superiority of denosumab over placebo was also established, overall survival time was tested at a 2-sided significance level of 0.050.||0.98|0.73|0.0284
71113283|NCT00286091|141734213|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0317|TWO_SIDED|95.0|0.71|0.98|||Wald test||Based on the Cox proportional hazards model stratified by PSA ≥ 8.0 ng/mL, PSA doubling time ≤ 10 months and previous or current chemotherapy for prostate cancer. A hazard ratio \< 1 favors denosumab.|||0.98|0.71|0.0317
71113284|NCT00286091|141734214|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9125|TWO_SIDED|95.0|0.85|1.2|||Wald test||Based on the Cox proportional hazards model stratified by PSA ≥ 8.0 ng/mL, PSA doubling time ≤ 10 months and previous or current chemotherapy for prostate cancer. A hazard ratio \< 1 favors denosumab.|||1.20|0.85|0.9125
71113285|NCT03423238|141734218|SUPERIORITY|||||||0.388|||||||t-test, 2 sided|||Baseline||||0.388
71069751|NCT03613649|141648909|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|0.17|||||ONE_SIDED|95.0||1.795||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 2 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||1.795||
71069752|NCT03613649|141648909|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.42|||||ONE_SIDED|95.0||3.044||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 3 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||3.044||
71113286|NCT03423238|141734219|SUPERIORITY|||||||0.017|||||||ANCOVA|||Month 3||||0.017
71113287|NCT03423238|141734219|SUPERIORITY|||||||0.002|||||||ANCOVA|||Month 6||||0.002
71113288|NCT03423238|141734220|SUPERIORITY|||||||0.653|||||||t-test, 2 sided|||Baseline||||0.653
71113289|NCT03423238|141734221|SUPERIORITY|||||||0.684|||||||ANCOVA|||Month 3||||0.684
71113290|NCT03423238|141734221|SUPERIORITY|||||||0.458|||||||ANCOVA|||Month 6||||0.458
71113291|NCT03423238|141734222|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||Baseline||||0.550
71113292|NCT03423238|141734223|SUPERIORITY|||||||0.973|||||||ANCOVA|||Month 3||||0.973
71113293|NCT03423238|141734223|SUPERIORITY|||||||0.432|||||||ANCOVA|||Month 6||||0.432
71069753|NCT03613649|141648909|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.17|||||ONE_SIDED|95.0||2.792||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 4 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||2.792||
71069754|NCT03613649|141648909|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|0.45|||||ONE_SIDED|95.0||2.074||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 6 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||2.074||
71069755|NCT03613649|141648909|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|-0.83|||||ONE_SIDED|95.0||0.79||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 8 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||0.790||
71069756|NCT03613649|141648909|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|0.03|||||ONE_SIDED|95.0||1.65||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 12 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||1.650||
71069757|NCT03613649|141648909|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|-0.53|||||ONE_SIDED|95.0||1.131||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 24 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||1.131||
71069758|NCT03613649|141648909|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.17|||||ONE_SIDED|95.0||2.815||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 0.5 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||2.815||
71069759|NCT03613649|141648909|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|2.36|||||ONE_SIDED|95.0||3.997||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 1 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||3.997||
71069760|NCT03613649|141648909|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|2.18|||||ONE_SIDED|95.0||3.812||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 2 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||3.812||
71069761|NCT03613649|141648909|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|2.59|||||ONE_SIDED|95.0||4.228||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 3 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||4.228||
71069762|NCT03613649|141648909|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|3.04|||||ONE_SIDED|95.0||4.674||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 4 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||4.674||
71069763|NCT03613649|141648909|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.63|||||ONE_SIDED|95.0||3.259||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 6 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||3.259||
71069764|NCT03613649|141648909|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|-0.07|||||ONE_SIDED|95.0||1.566||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 8 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||1.566||
71069765|NCT03613649|141648909|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.82|||||ONE_SIDED|95.0||3.459||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 12 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||3.459||
71069766|NCT03613649|141648909|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.72|||||ONE_SIDED|95.0||3.415||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 24 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||3.415||
71069767|NCT03613649|141648914|NON_INFERIORITY|"According to ICH E14, the positive control should have an effect on the mean QT/QTc interval of about 5 ms. Comparison of the lower bound of the confidence interval to 5 ms for a 400 mg dose of moxifloxacin is standard practice for demonstrating assay sensitivity in thorough QT studies."|Least-Squares Mean Double Delta Value|10.19|||||ONE_SIDED|98.75|8.257|||||||Null Hypothesis: The trial does not have the sensitivity to detect an effect on QTcF of regulatory concern, as produced by 400 mg moxifloxacin 1 h after dose.|||8.257|
71069768|NCT03613649|141648914|NON_INFERIORITY|"According to ICH E14, the positive control should have an effect on the mean QT/QTc interval of about 5 ms. Comparison of the lower bound of the confidence interval to 5 ms for a 400 mg dose of moxifloxacin is standard practice for demonstrating assay sensitivity in thorough QT studies."|Least-Squares Mean Double Delta Value|10.79|||||ONE_SIDED|98.75|8.86|||||||Null Hypothesis: The trial does not have the sensitivity to detect an effect on QTcF of regulatory concern, as produced by 400 mg moxifloxacin 2 h after dose.|||8.860|
71069769|NCT03613649|141648914|NON_INFERIORITY|"According to ICH E14, the positive control should have an effect on the mean QT/QTc interval of about 5 ms. Comparison of the lower bound of the confidence interval to 5 ms for a 400 mg dose of moxifloxacin is standard practice for demonstrating assay sensitivity in thorough QT studies."|Least-Squares Mean Double Delta Value|10.62|||||ONE_SIDED|98.75|8.683|||||||Null Hypothesis: The trial does not have the sensitivity to detect an effect on QTcF of regulatory concern, as produced by 400 mg moxifloxacin 3 h after dose.|||8.683|
71069770|NCT03613649|141648914|NON_INFERIORITY|"According to ICH E14, the positive control should have an effect on the mean QT/QTc interval of about 5 ms. Comparison of the lower bound of the confidence interval to 5 ms for a 400 mg dose of moxifloxacin is standard practice for demonstrating assay sensitivity in thorough QT studies."|Least-Squares Mean Double Delta Value|10.63|||||ONE_SIDED|98.75|8.698|||||||Null Hypothesis: The trial does not have the sensitivity to detect an effect on QTcF of regulatory concern, as produced by 400 mg moxifloxacin 4 h after dose.|||8.698|
71069771|NCT01500187|141648960|SUPERIORITY_OR_OTHER_LEGACY|||||||0.636|||||||ANOVA|||Null Hypothesis: there is no intergroup difference (α=0.05) in DIAGNOdent reading at baseline||||0.636
71069772|NCT01500187|141648960|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANOVA|||Null Hypothesis: there is no intergroup difference (α=0.05) in DIAGNOdent reading at three months||||0.001
71069773|NCT01500187|141648960|SUPERIORITY_OR_OTHER_LEGACY|||||||0.423|||||||ANOVA|||Null Hypothesis: there is no intergroup difference (α=0.05) in DIAGNOdent reading at six months||||0.423
71069774|NCT02537431|141648961|OTHER||Mean|-54.18|||<|0.0001|TWO_SIDED|95.0|-68.64|-39.72||The null hypothesis of no mean percent change from baseline is tested using t-test.|t-test|||||-39.72|-68.64|< 0.0001
71069775|NCT02537431|141648962|OTHER||||||<|0.0001||||||The p-value is for testing the proportion of participants achieving the mean serum phosphorus levels above the LLN (2.5 mg/dL \[0.81 mmol/L\]) against 0% from the binomial test.|binomial test|||||||<0.0001
71069776|NCT02537431|141648963|OTHER||Mean|-32.21|||<|0.0001|TWO_SIDED|95.0|-40.25|-24.17||The null hypothesis of no mean percent change from baseline is tested using t-test.|t-test|||||-24.17|-40.25|<0.0001
71069777|NCT02537431|141648964|OTHER||Mean|-26.0||||0.0002|TWO_SIDED|95.0|-36.08|-15.91||The null hypothesis of no mean percent change from baseline is tested using t-test.|t-test|||||-15.91|-36.08|0.0002
71069778|NCT02537431|141648965|OTHER||Mean|-52.24||||0.0199|TWO_SIDED|95.0|-94.08|-10.41||The null hypothesis of no mean percent change from baseline is tested using t-test.|t-test|||||-10.41|-94.08|0.0199
71069779|NCT02537431|141648977|OTHER||Least Squares Mean (GEE)|107.75|||||TWO_SIDED|95.0|76.46|139.03|||||From the generalized estimation equation (GEE) model which includes change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 1||139.03|76.46|
71069780|NCT02537431|141648977|OTHER||LS Mean|48.41|||||TWO_SIDED|95.0|33.91|62.91|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 2||62.91|33.91|
71069781|NCT02537431|141648977|OTHER||LS Mean|13.58|||||TWO_SIDED|95.0|6.85|20.31|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 4||20.31|6.85|
71069782|NCT02537431|141648977|OTHER||LS Mean|-1.34|||||TWO_SIDED|95.0|-8.43|5.75|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 20||5.75|-8.43|
71069783|NCT02537431|141648977|OTHER||LS Mean|31.75|||||TWO_SIDED|95.0|21.49|42.0|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 21||42.00|21.49|
71069784|NCT02537431|141648977|OTHER||LS Mean|11.5|||||TWO_SIDED|95.0|3.54|19.46|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 22||19.46|3.54|
71069785|NCT02537431|141648977|OTHER||LS Mean|-3.04|||||TWO_SIDED|95.0|-12.62|6.55|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 24||6.55|-12.62|
71069786|NCT02537431|141648977|OTHER||LS Mean|-1.72||||0.6821|TWO_SIDED|95.0|-9.93|6.5|||GEE model||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 48||6.50|-9.93|0.6821
71069787|NCT02537431|141648977|OTHER||LS mean|-5.73|||||TWO_SIDED|95.0|-12.38|0.92|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 60||0.92|-12.38|
71069788|NCT02537431|141648977|OTHER||LS mean|3.36|||||TWO_SIDED|95.0|-4.45|11.18|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 70||11.18|-4.45|
71069789|NCT02537431|141648977|OTHER||LS mean|-5.55|||||TWO_SIDED|95.0|-11.22|0.13|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 72||0.13|-11.22|
71113294|NCT03423238|141734224|SUPERIORITY|||||||0.23063|||||||t-test, 2 sided|||Baseline||||0.23063
71113295|NCT03423238|141734225|SUPERIORITY|||||||0.854|||||||ANCOVA|||Month 3||||0.854
71113296|NCT03423238|141734225|SUPERIORITY|||||||0.874|||||||ANCOVA|||Month 6||||0.874
71113297|NCT03423238|141734226|SUPERIORITY|||||||0.563|||||||t-test, 2 sided|||Baseline||||0.563
71113298|NCT03423238|141734227|SUPERIORITY|||||||0.008|||||||ANCOVA|||Month 3||||0.008
71113299|NCT03423238|141734227|SUPERIORITY|||||||0.922|||||||ANCOVA|||Month 6||||0.922
70938960|NCT00657709|141378543|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for 5/99 strain.|Vaccines Group Differences|0.0|||||TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval \[-10%, 10%\].||1|-1|
70938961|NCT00657709|141378543|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for 5/99 strain.|Vaccines Group Differences|1.0|||||TWO_SIDED|95.0|0.0|2.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval \[-10%, 10%\].||2|0|
70938962|NCT00657709|141378543|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for 5/99 strain.|Vaccines Group Differences|1.0|||||TWO_SIDED|95.0|0.0|2.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval \[-10%, 10%\].||2|0|
71113300|NCT03423238|141734228|SUPERIORITY|||||||0.667|||||||t-test, 2 sided|||Baseline||||0.667
71113301|NCT03423238|141734229|SUPERIORITY|||||||0.692|||||||ANCOVA|||Month 3||||0.692
71113302|NCT03423238|141734229|SUPERIORITY|||||||0.59|||||||ANCOVA|||Month 6||||0.590
71113303|NCT03423238|141734230|SUPERIORITY|||||||0.844|||||||t-test, 2 sided|||Baseline||||0.844
71113304|NCT03423238|141734231|SUPERIORITY|||||||0.721|||||||ANCOVA|||Month 3||||0.721
71113305|NCT03423238|141734231|SUPERIORITY|||||||0.851|||||||ANCOVA|||Month 6||||0.851
71113306|NCT03423238|141734232|SUPERIORITY|||||||0.815|||||||t-test, 2 sided|||Baseline||||0.815
71113307|NCT03423238|141734233|SUPERIORITY|||||||0.488|||||||ANCOVA|||Month 3||||0.488
71113308|NCT03423238|141734233|SUPERIORITY|||||||0.237|||||||ANCOVA|||Month 6||||0.237
71113309|NCT03423238|141734234|SUPERIORITY|||||||0.506|||||||t-test, 2 sided|||||||0.506
71113310|NCT03423238|141734235|SUPERIORITY|||||||0.549|||||||ANCOVA|||Month 3||||0.549
71113311|NCT03423238|141734235|SUPERIORITY|||||||0.303|||||||ANCOVA|||Month 6||||0.303
71113312|NCT03423238|141734236|SUPERIORITY|||||||0.934|||||||t-test, 2 sided|||Baseline||||0.934
71113313|NCT03423238|141734237|SUPERIORITY|||||||0.792|||||||ANCOVA|||Month 3||||0.792
71113314|NCT03423238|141734237|SUPERIORITY|||||||0.417|||||||ANCOVA|||Month 6||||0.417
71113315|NCT03423238|141734238|SUPERIORITY|||||||0.685|||||||t-test, 2 sided|||Baseline||||0.685
71113316|NCT03423238|141734239|SUPERIORITY|||||||0.854|||||||ANCOVA|||Month 3||||0.854
71113317|NCT03423238|141734239|SUPERIORITY|||||||0.903|||||||ANCOVA|||Month 6||||0.903
71113318|NCT03423238|141734240|SUPERIORITY|||||||0.569|||||||t-test, 2 sided|||Baseline||||0.569
71113319|NCT03423238|141734241|SUPERIORITY|||||||0.824|||||||ANCOVA|||Month 3||||0.824
71113320|NCT03423238|141734241|SUPERIORITY|||||||0.401|||||||ANCOVA|||Month 6||||0.401
71113321|NCT03423238|141734242|SUPERIORITY|||||||0.188|||||||t-test, 2 sided|||Baseline||||0.188
71113322|NCT03423238|141734243|SUPERIORITY|||||||0.338|||||||ANCOVA|||Month 3||||0.338
71113323|NCT03423238|141734243|SUPERIORITY|||||||0.484|||||||ANCOVA|||Month 6||||0.484
71113324|NCT03423238|141734244|SUPERIORITY|||||||0.533|||||||t-test, 2 sided|||Baseline||||0.533
71113325|NCT03423238|141734245|SUPERIORITY|||||||0.992|||||||ANCOVA|||Month 3||||0.992
71113326|NCT03423238|141734245|SUPERIORITY|||||||0.639|||||||ANCOVA|||Month 6||||0.639
71113327|NCT00923351|141734261|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED||||||Fisher Exact|||||||0.043
71113328|NCT05285644|141734287|OTHER|Difference (2-sided)|Difference in Percentages|34.4|||<|0.0001|TWO_SIDED|95.0|26.9|42.0||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|Pearson's Chi-squared test||Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|For binary endpoint, the underlying continuous measurement of unanesthetized Schirmer score was imputed, change score calculated and then dichotomized to ascertain attainment of greater than or equal to 10 millimeter increase from pre-drop baseline.|42.0|26.9|<0.0001
71069790|NCT02537431|141648977|OTHER||LS mean|-5.55|||||TWO_SIDED|95.0|-11.35|0.26|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 84||0.26|-11.35|
71069791|NCT02537431|141648977|OTHER||LS mean|9.63|||||TWO_SIDED|95.0|1.33|17.94|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 94||17.94|1.33|
71069792|NCT02537431|141648977|OTHER||LS mean|-6.09|||||TWO_SIDED|95.0|-10.8|-1.38||||||Week 96||-1.38|-10.80|
71069793|NCT02537431|141648977|OTHER||LS mean|0.02|||||TWO_SIDED|95.0|-9.22|9.26|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 108||9.26|-9.22|
71069794|NCT02537431|141648977|OTHER||LS mean|1.45|||||TWO_SIDED|95.0|-6.77|9.68|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 120||9.68|-6.77|
71069795|NCT02537431|141648977|OTHER||LS mean|-1.69|||||TWO_SIDED|95.0|-5.6|2.21|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 132||2.21|-5.60|
71069796|NCT02537431|141648978|OTHER||LS Mean|0.1|||||TWO_SIDED|95.0|-0.15|0.35|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 12||0.35|-0.15|
71069797|NCT02537431|141648978|OTHER||LS Mean|-0.04|||||TWO_SIDED|95.0|-0.19|0.11|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 24||0.11|-0.19|
71069798|NCT02537431|141648978|OTHER||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.12|0.11|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 36||0.11|-0.12|
71069799|NCT02537431|141648978|OTHER||LS Mean|-0.04||||0.6021|TWO_SIDED|95.0|-0.19|0.11|||GEE model||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 48||0.11|-0.19|0.6021
71069800|NCT02537431|141648978|OTHER||LS mean|0.0|||||TWO_SIDED|95.0|-0.19|0.19|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 72||0.19|-0.19|
71069801|NCT02537431|141648978|OTHER||LS mean|-0.13|||||TWO_SIDED|95.0|-0.29|0.03|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 96||0.03|-0.29|
71069802|NCT02537431|141648978|OTHER||LS mean|-0.07|||||TWO_SIDED|95.0|-0.41|0.26|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|EOS II||0.26|-0.41|
71069803|NCT02537431|141648979|OTHER||LS Mean|1.76|||||TWO_SIDED|95.0|1.49|2.03|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 2||2.03|1.49|
71069804|NCT02537431|141648979|OTHER||LS Mean|0.78|||||TWO_SIDED|95.0|0.59|0.97|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 4||0.97|0.59|
71069805|NCT02537431|141648979|OTHER||LS Mean|0.58|||||TWO_SIDED|95.0|0.34|0.82|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 12||0.82|0.34|
71069806|NCT02537431|141648979|OTHER||LS Mean|0.87|||||TWO_SIDED|95.0|0.74|0.99|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 22||0.99|0.74|
71069807|NCT02537431|141648979|OTHER||LS Mean|0.44|||||TWO_SIDED|95.0|0.24|0.64|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 24||0.64|0.24|
71069808|NCT02537431|141648979|OTHER||LS Mean|0.2||||0.043|TWO_SIDED|95.0|0.01|0.38|||GEE model||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 48||0.38|0.01|0.0430
71069809|NCT02537431|141648979|OTHER||LS mean|0.3|||||TWO_SIDED|95.0|-0.04|0.64|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 60||0.64|-0.04|
71069810|NCT02537431|141648979|OTHER||LS mean|0.28|||||TWO_SIDED|95.0|0.03|0.52|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 72||0.52|0.03|
71069811|NCT02537431|141648979|OTHER||LS mean|0.39|||||TWO_SIDED|95.0|0.13|0.66|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 84||0.66|0.13|
71069812|NCT02537431|141648979|OTHER||LS mean|0.29|||||TWO_SIDED|95.0|0.1|0.48|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 96||0.48|0.10|
71069813|NCT02537431|141648979|OTHER||LS mean|0.21|||||TWO_SIDED|95.0|0.08|0.34|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|EOSII||0.34|0.08|
71069814|NCT02537431|141648980|OTHER||LS Mean|0.07|||||TWO_SIDED|95.0|0.06|0.08|||||From the GEE model, which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 2||0.08|0.06|
71069815|NCT02537431|141648980|OTHER||LS Mean|0.03|||||TWO_SIDED|95.0|0.01|0.06|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 4||0.06|0.01|
71069816|NCT02537431|141648980|OTHER||LS Mean|0.01|||||TWO_SIDED|95.0|-0.01|0.04|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 12||0.04|-0.01|
71029060|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.901|TWO_SIDED|95.0|0.77|1.34||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 90 and 105 minutes postdose||1.34|0.77|0.901
71029061|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.6|TWO_SIDED|95.0|0.7|1.23||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 105 and 120 minutes postdose||1.23|0.70|0.600
71029062|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.853|TWO_SIDED|95.0|0.74|1.29||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 105 and 120 minutes postdose||1.29|0.74|0.853
71029063|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.736|TWO_SIDED|95.0|0.79|1.39||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 105 and 120 minutes postdose||1.39|0.79|0.736
71029064|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.744|TWO_SIDED|95.0|0.7|1.3||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 120 and 135 minutes postdose||1.30|0.70|0.744
71029065|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.904|TWO_SIDED|95.0|0.72|1.33||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 120 and 135 minutes postdose||1.33|0.72|0.904
71029066|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.828|TWO_SIDED|95.0|0.77|1.39||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 120 and 135 minutes postdose||1.39|0.77|0.828
71029067|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.147|TWO_SIDED|95.0|0.59|1.08||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 135 and 150 minutes postdose||1.08|0.59|0.147
71029068|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.345|TWO_SIDED|95.0|0.65|1.16||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 135 and 150 minutes postdose||1.16|0.65|0.345
71029069|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.532|TWO_SIDED|95.0|0.83|1.44||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 135 and 150 minutes postdose||1.44|0.83|0.532
71029070|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.261|TWO_SIDED|95.0|0.61|1.15||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 150 and 165 minutes postdose||1.15|0.61|0.261
71029071|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.601|TWO_SIDED|95.0|0.69|1.24||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 150 and 165 minutes postdose||1.24|0.69|0.601
71069817|NCT02537431|141648980|OTHER||LS Mean|0.04|||||TWO_SIDED|95.0|0.02|0.05|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 22||0.05|0.02|
71069818|NCT02537431|141648980|OTHER||LS Mean|0.01|||||TWO_SIDED|95.0|-0.02|0.04||||||Week 24||0.04|-0.02|
71069819|NCT02537431|141648980|OTHER||LS Mean|0.0||||0.8377|TWO_SIDED|95.0|-0.05|0.04|||GEE model||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 48||0.04|-0.05|0.8377
71069820|NCT02537431|141648980|OTHER||LS mean|0.03|||||TWO_SIDED|95.0|0.0|0.06|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 60||0.06|-0.00|
71113329|NCT05285644|141734288|OTHER|Difference (2-sided)|Least Squares Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|2.06||0.0138|TWO_SIDED|95.0|-9.1|-1.0||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center.|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||-1.0|-9.1|0.0138
71113330|NCT05285644|141734289|OTHER|Difference (2-sided)|Least Squares Mean Difference|7.2|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|TWO_SIDED|95.0|5.8|8.6||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|8.6|5.8|<0.0001
71113331|NCT05285644|141734290|OTHER|Difference (2-sided)|Difference in Percentages|26.7|||<|0.0001|TWO_SIDED|95.0|19.5|34.0||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|Pearson's Chi-squared test||Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|For binary endpoint, the underlying continuous measurement of unanesthetized Schirmer score was imputed, change score calculated and then dichotomized to ascertain attainment of greater than or equal to 10 millimeter increase from pre-drop baseline.|34.0|19.5|<0.0001
71069821|NCT02537431|141648980|OTHER||LS mean|-0.02|||||TWO_SIDED|95.0|-0.09|0.05|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 72||0.05|-0.09|
71069822|NCT02537431|141648980|OTHER||LS mean|0.02|||||TWO_SIDED|95.0|-0.01|0.06|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 84||0.06|-0.01|
71069823|NCT02537431|141648980|OTHER||LS mean|0.02|||||TWO_SIDED|95.0|-0.01|0.05|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 96||0.05|-0.01|
71069824|NCT02537431|141648980|OTHER||LS mean|0.01|||||TWO_SIDED|95.0|-0.01|0.03|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|EOSII||0.03|-0.01|
71069825|NCT02537431|141648981|OTHER||LS Mean|99.18|||||TWO_SIDED|95.0|76.83|121.53|||||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 12||121.53|76.83|
71069826|NCT02537431|141648981|OTHER||LS Mean|104.33|||||TWO_SIDED|95.0|82.47|126.19|||||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 24||126.19|82.47|
71069827|NCT02537431|141648981|OTHER||LS Mean|52.49|||<|0.0001|TWO_SIDED|95.0|29.84|75.13|||GEE model||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 48||75.13|29.84|< 0.0001
70938963|NCT00657709|141378543|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for NZ98/254 strain.|Percentage group difference|3.0|||||TWO_SIDED|95.0|-2.0|8.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentages of subjects with hSBA titers ≥ 1:5 at 1 month after the third dose, were entirely within the interval \[-10%, 10%\].||8|-2|
70938964|NCT00657709|141378543|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for NZ 98/254 strain.|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-6.0|4.0|||Miettinen and Nurminen|The lot-to-lot difference in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1 month after the third dise, were entirely within the interval \[-10%, 10%\].||4|-6|
71069828|NCT02537431|141648981|OTHER||LS mean|37.29|||||TWO_SIDED|95.0|13.19|61.38|||||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 72||61.38|13.19|
71069829|NCT02537431|141648981|OTHER||LS mean|29.29|||||TWO_SIDED|95.0|3.18|55.4|||||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 96||55.40|3.18|
71069830|NCT02537431|141648981|OTHER||LS mean|2.14|||||TWO_SIDED|95.0|-17.67|21.94|||||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|EOSII||21.94|-17.67|
71069831|NCT02537431|141648982|OTHER||LS Mean|133.08|||||TWO_SIDED|95.0|106.26|159.89|||||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 12||159.89|106.26|
71069832|NCT02537431|141648982|OTHER||LS Mean|137.8|||||TWO_SIDED|95.0|106.95|168.65|||||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 24||168.65|106.95|
71069833|NCT02537431|141648982|OTHER||LS Mean|76.86|||<|0.0001|TWO_SIDED|95.0|49.2|104.53|||GEE model||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 48||104.53|49.20|< 0.0001
71069834|NCT02537431|141648982|OTHER||LS mean|50.46|||||TWO_SIDED|95.0|23.69|77.23|||||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 72||77.23|23.69|
71069835|NCT02537431|141648982|OTHER||LS mean|41.36|||||TWO_SIDED|95.0|18.69|64.03|||||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 96||64.03|18.69|
71069836|NCT02537431|141648982|OTHER||LS mean|26.2|||||TWO_SIDED|95.0|6.76|45.64|||||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|EOSII||45.64|6.76|
71069837|NCT02537431|141648983|OTHER||LS Mean|464.84|||||TWO_SIDED|95.0|343.92|585.77|||||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 12||585.77|343.92|
71069838|NCT02537431|141648983|OTHER||LS Mean|404.13|||||TWO_SIDED|95.0|294.47|513.78|||||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 24||513.78|294.47|
71069839|NCT02537431|141648983|OTHER||LS Mean|175.13|||<|0.0001|TWO_SIDED|95.0|88.85|261.41|||GEE model||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 48||261.41|88.85|< 0.0001
71069840|NCT02537431|141648983|OTHER||LS mean|143.11|||||TWO_SIDED|95.0|-38.2|324.41|||||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 72||324.41|-38.20|
71069841|NCT02537431|141648983|OTHER||LS mean|76.8|||||TWO_SIDED|95.0|-35.62|189.22|||||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 96||189.22|-35.62|
71069842|NCT02537431|141648983|OTHER||LS mean|-41.32|||||TWO_SIDED|95.0|-204.28|121.64|||||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|EOSII||121.64|-204.28|
71069843|NCT02537431|141648984|OTHER||LS Mean|89.68|||||TWO_SIDED|95.0|63.58|115.78|||||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 12||115.78|63.58|
71069844|NCT02537431|141648984|OTHER||LS Mean|70.17|||||TWO_SIDED|95.0|49.9|90.44|||||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 24||90.44|49.90|
71069845|NCT02537431|141648984|OTHER||LS Mean|35.86|||<|0.0001|TWO_SIDED|95.0|21.37|50.36|||GEE model||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 48||50.36|21.37|< 0.0001
71113332|NCT05285644|141734291|OTHER|Difference (2-sided)|Least Squares Mean Difference|6.2|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001|TWO_SIDED|95.0|4.9|7.5||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||7.5|4.9|<0.0001
71113333|NCT05285644|141734292|OTHER|Difference (2 sided)|Difference in Percentages|33.1|||<|0.0001|TWO_SIDED|95.0|24.8|41.4||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|Pearson's Chi-squared test||Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|For binary endpoint, the underlying continuous measurement of unanesthetized Schirmer score was imputed, change score calculated and then dichotomized to ascertain attainment of greater than or equal to 10 millimeter increase from pre-drop baseline.|41.4|24.8|<0.0001
71069846|NCT02537431|141648984|OTHER||LS mean|34.0|||||TWO_SIDED|95.0|6.53|61.47|||||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 72||61.47|6.53|
71069847|NCT02537431|141648984|OTHER||LS mean|25.86|||||TWO_SIDED|95.0|9.27|42.44|||||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 96||42.44|9.27|
71069848|NCT02537431|141648984|OTHER||LS mean|17.88|||||TWO_SIDED|95.0|-0.32|36.07|||||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|EOSII||36.07|-0.32|
71069849|NCT02537431|141648985|OTHER||LS Mean|10.93|||||TWO_SIDED|95.0|3.98|17.89|||||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 12||17.89|3.98|
71069850|NCT02537431|141648985|OTHER||LS Mean|5.82|||||TWO_SIDED|95.0|-0.02|11.66|||||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 24||11.66|-0.02|
71069851|NCT02537431|141648985|OTHER||LS Mean|4.5||||0.2592|TWO_SIDED|95.0|-3.32|12.32|||GEE model||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 48||12.32|-3.32|0.2592
71069852|NCT02537431|141648985|OTHER||LS mean|3.13|||||TWO_SIDED|95.0|-1.64|7.9|||||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 72||7.90|-1.64|
71069853|NCT02537431|141648985|OTHER||LS mean|1.14|||||TWO_SIDED|95.0|-2.84|5.11|||||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 96||5.11|-2.84|
71069854|NCT02537431|141648985|OTHER||LS mean|-5.8|||||TWO_SIDED|95.0|-12.46|0.85|||||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|EOSII||0.85|-12.46|
71069855|NCT02537431|141648986|OTHER||LS Mean|52.54|||||TWO_SIDED|95.0|21.18|83.9|||||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 12||83.90|21.18|
71069856|NCT02537431|141648986|OTHER||LS Mean|31.37|||||TWO_SIDED|95.0|8.23|54.51|||||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 24||54.51|8.23|
71069857|NCT02537431|141648986|OTHER||l|24.35||||0.1672|TWO_SIDED|95.0|-10.2|58.9|||GEE model||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 48||58.90|-10.20|0.1672
71069858|NCT02537431|141648986|OTHER||LS mean|15.13|||||TWO_SIDED|95.0|-11.19|41.46|||||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 72||41.46|-11.19|
71069859|NCT02537431|141648986|OTHER||LS mean|6.92|||||TWO_SIDED|95.0|-13.44|27.28|||||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 96||27.28|-13.44|
71069860|NCT02537431|141648986|OTHER||LS mean|-27.3|||||TWO_SIDED|95.0|-52.33|-2.28|||||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|EOSII||-2.28|-52.33|
70938965|NCT00657709|141378543|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided (5% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for NZ98/254 strain.|Percentage group difference|-4.0|||||TWO_SIDED|95.0|-9.0|1.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at one month after the third dose, were entirely within the interval \[-10%, 10%\].||1|-9|
70938966|NCT00657709|141378546|NON_INFERIORITY_OR_EQUIVALENCE|GMCs (GMCrMenB+OMV NZ lot1+lot2+lot3+InfanrixHexa / GMCInfanrixHexa)|Geometric group difference|0.84|||||TWO_SIDED|95.0|0.76|0.94|||ANOVA|GMCs and 95% CIs were constructed by exponentiating (base 10) the least squares means of the log10-transformed titers and their associated 95% CIs.||Immunogenicity of the pertussis components (FHA) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after the third vaccination is ≥0.67.||0.94|0.76|
70938967|NCT00657709|141378546|NON_INFERIORITY_OR_EQUIVALENCE|GMCs (GMCrMenB+OMV NZ lot1+lot2+lot3+InfanrixHexa / GMCInfanrixHexa)|Geometric group difference|0.77|||||TWO_SIDED|95.0|0.67|0.89|||ANOVA|GMCs and 95% CIs were constructed by exponentiating (base 10) the least square means of the log10-transformed titers and their associated 95% CIs.||Immunogenicity of the pertussis component (Pertactin) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of the routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after the third vaccination is ≥0.67.||0.89|0.67|
70938968|NCT00657709|141378546|NON_INFERIORITY_OR_EQUIVALENCE|GMCs (GMCrMenB+OMV NZ lot1+lot2+lot3+InfanrixHexa / GMCInfanrixHexa)|Geometric group difference|0.8|||||TWO_SIDED|95.0|0.71|0.91|||ANOVA|GMCs and 95% CIs were constructed by exponentiating (base 10) the least squares means of the log10-transformed titers and their associated 95% CIS.||Immunogenicity of the pertussis components (PT) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of the routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after the third vaccination is ≥0.67.||0.91|0.71|
71069861|NCT01340027|141648993|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|7.44||0.97|TWO_SIDED|95.0|-14.3|14.9|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and Baseline value as a covariate.~Least squares (LS) mean differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||14.9|-14.3|0.97
71069862|NCT01340027|141648993|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|6.15||0.58|TWO_SIDED|95.0|-8.6|15.5|||ANCOVA|||||15.5|-8.6|0.58
71069863|NCT01340027|141648993|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|6.13||0.33|TWO_SIDED|95.0|-6.1|18.0|||ANCOVA|||||18.0|-6.1|0.33
71069864|NCT01340027|141648993|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|17.6|STANDARD_ERROR_OF_MEAN|6.2||0.005|TWO_SIDED|95.0|5.4|29.8|||ANCOVA|||||29.8|5.4|0.005
71069865|NCT01340027|141648993|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|18.2|STANDARD_ERROR_OF_MEAN|6.1||0.003|TWO_SIDED|95.0|6.2|30.2|||ANCOVA|||||30.2|6.2|0.003
71069866|NCT01340027|141648993|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|21.7|STANDARD_ERROR_OF_MEAN|7.37||0.003|TWO_SIDED|95.0|7.2|36.1|||ANCOVA|||||36.1|7.2|0.003
71069867|NCT01340027|141648993|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|26.3|STANDARD_ERROR_OF_MEAN|7.32|<|0.001|TWO_SIDED|95.0|11.9|40.7|||ANCOVA|||||40.7|11.9|<0.001
71069868|NCT01340027|141648993|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.0|STANDARD_ERROR_OF_MEAN|8.46||0.2|TWO_SIDED|95.0|-5.6|27.6|||ANCOVA|||||27.6|-5.6|0.20
71069869|NCT01340027|141648993|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|20.5|STANDARD_ERROR_OF_MEAN|8.43||0.015|TWO_SIDED|95.0|4.0|37.1|||ANCOVA|||||37.1|4.0|0.015
71069870|NCT01340027|141648993|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|22.4|STANDARD_ERROR_OF_MEAN|8.43||0.008|TWO_SIDED|95.0|5.9|39.0|||ANCOVA|||||39.0|5.9|0.008
71069871|NCT01340027|141648993|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|22.0|STANDARD_ERROR_OF_MEAN|7.32||0.003|TWO_SIDED|95.0|7.6|36.3|||ANCOVA|||||36.3|7.6|0.003
71069872|NCT01340027|141648993|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|22.2|STANDARD_ERROR_OF_MEAN|8.46||0.009|TWO_SIDED|95.0|5.6|38.8|||ANCOVA|||||38.8|5.6|0.009
71069873|NCT01340027|141648993|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|25.4|STANDARD_ERROR_OF_MEAN|7.35|<|0.001|TWO_SIDED|95.0|11.0|39.8|||ANCOVA|||||39.8|11.0|<0.001
71069874|NCT01340027|141648993|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|27.9|STANDARD_ERROR_OF_MEAN|7.34|<|0.001|TWO_SIDED|95.0|13.5|42.3|||ANCOVA|||||42.3|13.5|<0.001
71069875|NCT01340027|141648993|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|39.6|STANDARD_ERROR_OF_MEAN|7.39|<|0.001|TWO_SIDED|95.0|25.1|54.1|||ANCOVA|||||54.1|25.1|<0.001
71069876|NCT01340027|141648993|SUPERIORITY_OR_OTHER_LEGACY||LS Mean DIfference|40.2|STANDARD_ERROR_OF_MEAN|7.31|<|0.001|TWO_SIDED|95.0|25.8|54.5|||ANCOVA|||||54.5|25.8|<0.001
71069877|NCT01340027|141648993|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|43.6|STANDARD_ERROR_OF_MEAN|8.42|<|0.001|TWO_SIDED|95.0|27.1|60.1|||ANCOVA|||||60.1|27.1|<0.001
71069878|NCT01340027|141648993|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|48.3|STANDARD_ERROR_OF_MEAN|8.35|<|0.001|TWO_SIDED|95.0|31.9|64.7|||ANCOVA|||||64.7|31.9|<0.001
71079370|NCT02087943|141666391|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.6||||0.0347|TWO_SIDED|95.0|-39.7|-1.5||Based on an analysis of covariance model with the percentage change from Baseline as the response variable and the treatment group and Baseline EASI score stratification (≤ 20, \> 20) as factors.|ANCOVA|||||-1.50|-39.70|0.0347
71069879|NCT01340027|141648994|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.366||0.062|TWO_SIDED|95.0|-1.4|0.03|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||0.03|-1.40|0.062
71069880|NCT01340027|141648994|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.302||0.91|TWO_SIDED|95.0|-0.63|0.56|||ANCOVA|||||0.56|-0.63|0.91
71069881|NCT01340027|141648994|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.302||0.2|TWO_SIDED|95.0|-0.98|0.2|||ANCOVA|||||0.20|-0.98|0.20
71069882|NCT01340027|141648994|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.305||0.96|TWO_SIDED|95.0|-0.62|0.58|||ANCOVA|||||0.58|-0.62|0.96
71069883|NCT01340027|141648994|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.3||0.007|TWO_SIDED|95.0|-1.39|-0.22|||ANCOVA|||||-0.22|-1.39|0.007
71069884|NCT01340027|141648994|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.363||0.016|TWO_SIDED|95.0|-1.59|-0.16|||ANCOVA|||||-0.16|-1.59|0.016
71069885|NCT01340027|141648994|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.36||0.007|TWO_SIDED|95.0|-1.68|-0.27|||ANCOVA|||||-0.27|-1.68|0.007
71069886|NCT01340027|141648994|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.417||0.91|TWO_SIDED|95.0|-0.87|0.77|||ANCOVA|||||0.77|-0.87|0.91
71069887|NCT01340027|141648994|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.415||0.76|TWO_SIDED|95.0|-0.94|0.69|||ANCOVA|||||0.69|-0.94|0.76
71069888|NCT01340027|141648994|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.416||0.99|TWO_SIDED|95.0|-0.82|0.81|||ANCOVA|||||0.81|-0.82|0.99
71069889|NCT01340027|141648994|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.361||0.77|TWO_SIDED|95.0|-0.82|0.6|||ANCOVA|||||0.60|-0.82|0.77
71069890|NCT01340027|141648994|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.417||0.058|TWO_SIDED|95.0|-1.61|0.03|||ANCOVA|||||0.03|-1.61|0.058
71069891|NCT01340027|141648994|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.362||0.69|TWO_SIDED|95.0|-0.85|0.57|||ANCOVA|||||0.57|-0.85|0.69
71069892|NCT01340027|141648994|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.362||0.17|TWO_SIDED|95.0|-1.21|0.21|||ANCOVA|||||0.21|-1.21|0.17
71069893|NCT01340027|141648994|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.364||0.73|TWO_SIDED|95.0|-0.84|0.59|||ANCOVA|||||0.59|-0.84|0.73
71069894|NCT01340027|141648994|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.361||0.012|TWO_SIDED|95.0|-1.62|-0.2|||ANCOVA|||||-0.20|-1.62|0.012
71069895|NCT01340027|141648994|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.414||0.018|TWO_SIDED|95.0|-1.8|-0.17|||ANCOVA|||||-0.17|-1.80|0.018
71069896|NCT01340027|141648994|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.412||0.009|TWO_SIDED|95.0|-1.89|-0.28|||ANCOVA|||||-0.28|-1.89|0.009
71069897|NCT01340027|141648995|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.46||0.51|TWO_SIDED|95.0|-1.0|0.82||Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.|Stratified Rank ANCOVA|P-values are from pairwise comparisons of the combination/active treatment groups vs. solifenacin 5 mg/placebo within a stratified rank ANCOVA model.||The ANCOVA model including the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and Baseline measurement as a covariate was used to calculate point estimates and 95% confidence intervals (CI) for change from Baseline within each treatment group and for differences between combination treatment groups and solifenacin 5 mg as well as for differences between active treatment groups and placebo.||0.82|-1.00|0.51
71069898|NCT01340027|141648995|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.355||0.21|TWO_SIDED|95.0|-0.57|0.83|||Stratified Rank ANCOVA|||||0.83|-0.57|0.21
71069899|NCT01340027|141648995|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.361||0.89|TWO_SIDED|95.0|-0.68|0.74|||Stratified Rank ANCOVA|||||0.74|-0.68|0.89
71069900|NCT01340027|141648995|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.365||0.001|TWO_SIDED|95.0|-1.06|0.38||P values were calculated from a pairwise comparison of the combination treatment groups vs solifenacin succinate 5 mg or placebo within the ANCOVA model.|Stratified Rank ANCOVA|||||0.38|-1.06|0.001
71069901|NCT01340027|141648995|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.397||0.058|TWO_SIDED|95.0|-1.04|0.52|||Stratified Rank ANCOVA|||||0.52|-1.04|0.058
71069902|NCT01340027|141648995|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.395||0.15|TWO_SIDED|95.0|-0.17|1.38|||Stratified Rank ANCOVA|||||1.38|-0.17|0.15
71069903|NCT01340027|141648995|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.417||0.41|TWO_SIDED|95.0|-0.91|0.73|||Stratified Rank ANCOVA|||||0.73|-0.91|0.41
71069904|NCT01340027|141648995|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.554||0.44|TWO_SIDED|95.0|-0.88|1.3|||Stratified Rank ANCOVA|||||1.30|-0.88|0.44
71069905|NCT01340027|141648995|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.505||0.85|TWO_SIDED|95.0|-0.95|1.04|||Stratified Rank ANCOVA|||||1.04|-0.95|0.85
71069906|NCT01340027|141648995|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.533||0.83|TWO_SIDED|95.0|-1.36|0.74|||Stratified Rank ANCOVA|||||0.74|-1.36|0.83
71069907|NCT01340027|141648995|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.444||0.56|TWO_SIDED|95.0|-0.8|0.95|||Stratified Rank ANCOVA|||||0.95|-0.80|0.56
71069908|NCT01340027|141648995|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.534||0.48|TWO_SIDED|95.0|-1.07|1.03|||Stratified Rank ANCOVA|||||1.03|-1.07|0.48
70938969|NCT00657709|141378547|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|0.0|||||TWO_SIDED|95.0|-1.0|2.0|||Miettinen and Nurminen|||Immunogenicity of the routine infant vaccines, when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age,would be considered non-inferior to that of routine infant vaccines given alone, for diphtheria toxoids antigen, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than or equal to the cut-off level ≥0.1 IU/mL for that antigen.||2|-1|
70938970|NCT00657709|141378547|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-5.0|||||TWO_SIDED|95.0|-12.0|1.0|||Miettinen and Nurminen|||Immunogenicity of the routine infant vaccines, when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age, would be considered non-inferior to that of routine infant vaccines given alone, for diphtheria toxoids antigen, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than or equal to the cut-off level ≥1.0 IU/mL for that antigen.||1|-12|
70938971|NCT00657709|141378547|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|||Immunogenicity of the routine infant vaccines, when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age, would be considered non-inferior to that of routine infant vaccines given alone, for Tetanus toxoids antigen, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than or equal to the cut-off level ≥0.1 IU/mL for that antigen.||2|-2|
70938972|NCT00657709|141378547|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-4.0|||||TWO_SIDED|95.0|-9.0|1.0|||Miettinen and Nurminen|||Immunogenicity of the routine infant vaccines, when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age, would be considered non-inferior to that of routine infant vaccines given alone, for Tetanus toxoids antigen, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than or equal to the cut-off level ≥1.0 IU/mL for that antigen.||1|-9|
70938973|NCT00657709|141378547|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-5.0|2.0|||Miettinen and Nurminen|||Immunogenicity of the polio type 1 of Diphtheria-Tetanus-Acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b (DTPa-HBV-IPV) when given concomitantly with rMenB and Pneumococcal 7-valent conjugate vaccine (PCV7) at 2, 4, and 6 months of age would be considered non-inferior to that of the confidence interval for the difference in the percentage of subjects with NT titers ≥1:8 was greater than -10%.||2|-5|
70938974|NCT00657709|141378547|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|vaccine group difference|-5.0|||||TWO_SIDED|95.0|-11.0|-1.0|||Miettinen and Nurminen|||Immunogenicity of the polio type 2 of Diphtheria-Tetanus-Acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b (DTPa-HBVIPV) when given concomitantly with rMenB and Pneumococcal 7-valent conjugate vaccine (PCV7) at 2, 4, and 6 months of age would be considered non-inferior to that of the confidence interval for the difference in the percentage of subjects with NT titers ≥1:8 was greater than -10%.||-1|-11|
70938975|NCT00657709|141378547|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-4.0|2.0|||Miettinen and Nurminen|||Immunogenicity of the polio type 3 of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 at 2,4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two sided 95% confidence interval for the difference in the percentage of subjects with NT titers ≥1:8 was greater than -10%.||2|-4|
71029072|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.47|TWO_SIDED|95.0|0.84|1.47||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 150 and 165 minutes postdose||1.47|0.84|0.470
71029073|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.834|TWO_SIDED|95.0|0.71|1.32||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 165 and 180 minutes postdose||1.32|0.71|0.834
71029074|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.628|TWO_SIDED|95.0|0.81|1.43||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 165 and 180 minutes postdose||1.43|0.81|0.628
71029075|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.481|TWO_SIDED|95.0|0.83|1.48||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 165 and 180 minutes postdose||1.48|0.83|0.481
71029076|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.749|TWO_SIDED|95.0|0.65|1.37||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 180 and 195 minutes postdose||1.37|0.65|0.749
71029077|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.857|TWO_SIDED|95.0|0.7|1.35||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 180 and 195 minutes postdose||1.35|0.70|0.857
71029078|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.847|TWO_SIDED|95.0|0.76|1.41||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 180 and 195 minutes postdose||1.41|0.76|0.847
70938976|NCT00657709|141378547|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|percentage group difference|-2.0|||||TWO_SIDED|95.0|-5.0|-1.0|||Miettinen and Nurminen|||Immunogenicity of the hepatitis B surface antigen component of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two sided 95% confidence interval for the difference in the percentage of subjects with NT ≥10.0 mIU/ml was greater than -10%||-1|-5|
70938977|NCT00657709|141378547|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|percentage group difference|-1.0|||||TWO_SIDED|95.0|-3.0|1.0|||Miettinen and Nurminen|||Immunogenicity of the PRP-Hib component of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 vaccine at 2, 4, and 6 months of age would be considered non-inferiority that of the routine vaccinations given alone, if the lower limit of the two sided 95% confidence interval for the difference in the percentage of subjects with Hib capsular polysaccharide (PRP) antibody response greater than the protective cutoff of ≥0.15 μg/mL was greater than -10%.||1|-3|
70938978|NCT00657709|141378547|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|vaccine group difference|0.0|||||TWO_SIDED|95.0|-7.0|7.0|||Miettinen and Nurminen|||Immunogenicity of the PRP-Hib component of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two sided 95% confidence interval for the difference in the percentage of subjects with Hib capsular polysaccharide (PRP) antibody response greater than the protective cutoff of ≥1.0 μg/mL was greater than -10%.||7|-7|
71069909|NCT01340027|141648995|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.443||0.13|TWO_SIDED|95.0|-0.67|1.07|||Stratified Rank ANCOVA|||||1.07|-0.67|0.13
71069910|NCT01340027|141648995|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.448||0.62|TWO_SIDED|2.0|-0.78|0.99|||Stratified Rank ANCOVA|||||0.99|-0.78|0.62
71069911|NCT01340027|141648995|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.454||0.34|TWO_SIDED|95.0|-1.16|0.63|||Stratified Rank ANCOVA|||||0.63|-1.16|0.34
71069912|NCT01340027|141648995|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.472||0.24|TWO_SIDED|95.0|-1.12|0.74|||Stratified Rank ANCOVA|||||0.74|-1.12|0.24
71069913|NCT01340027|141648995|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.68|STANDARD_ERROR_OF_MEAN|0.475||0.88|TWO_SIDED|95.0|-0.26|1.61|||Stratified Rank ANCOVA|||||1.61|-0.26|0.88
71069914|NCT01340027|141648995|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.494||0.83|TWO_SIDED|95.0|-0.99|0.95|||Stratified Rank ANCOVA|||||0.95|-0.99|0.83
71069915|NCT01340027|141648998|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.29||||0.42|TWO_SIDED|95.0|0.69|2.39|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||2.39|0.69|0.42
71069916|NCT01340027|141648998|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.2||||0.48|TWO_SIDED|95.0|0.72|2.0|||Regression, Logistic|||||2.00|0.72|0.48
71069917|NCT01340027|141648998|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.11||||0.69|TWO_SIDED|95.0|0.67|1.83|||Regression, Logistic|||||1.83|0.67|0.69
71069918|NCT01340027|141648998|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.02||||0.95|TWO_SIDED|95.0|0.61|1.69|||Regression, Logistic|||||1.69|0.61|0.95
71069919|NCT01340027|141648998|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.91||||0.015|TWO_SIDED|95.0|1.14|3.21|||Regression, Logistic|||||3.21|1.14|0.015
71069920|NCT01340027|141648998|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.06||||0.023|TWO_SIDED|95.0|1.11|3.84|||Regression, Logistic|||||3.84|1.11|0.023
71069921|NCT01340027|141648998|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.54||||0.16|TWO_SIDED|95.0|0.84|2.84|||Regression, Logistic|||||2.84|0.84|0.16
71069922|NCT01340027|141648998|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.89||||0.73|TWO_SIDED|95.0|0.45|1.76|||Regression, Logistic|||||1.76|0.45|0.73
71069923|NCT01340027|141648998|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.88||||0.7|TWO_SIDED|95.0|0.45|1.72|||Regression, Logistic|||||1.72|0.45|0.70
71069924|NCT01340027|141648998|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.49||||0.26|TWO_SIDED|95.0|0.74|2.99|||Regression, Logistic|||||2.99|0.74|0.26
71069925|NCT01340027|141648998|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.13||||0.69|TWO_SIDED|95.0|0.63|2.04|||Regression, Logistic|||||2.04|0.63|0.69
70852808|NCT02744040|141194420|OTHER|Tukey's Honest Significant Difference (HSD) test|||||>|0.05||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in TILDA stimulation was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for TILDA Stimulation.||||>0.05
71069926|NCT01340027|141648998|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.45||||0.29|TWO_SIDED|95.0|0.73|2.89|||Regression, Logistic|||||2.89|0.73|0.29
71069927|NCT01340027|141648998|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.36||||0.31|TWO_SIDED|95.0|0.75|2.45|||Regression, Logistic|||||2.45|0.75|0.31
70852809|NCT00096356|141194428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|1.03||0.1815|TWO_SIDED|95.0|-3.39|0.64||The a priori significance level was 0.05 for the primary outcome; there is no adjustment for multiple comparisons.|Mixed Models Analysis||This is the estimate of the difference in arms (Co-Q10 minus placebo). Lower is better for this outcome.|Constrained repeated measures analysis of variance - constrained such that baseline fatigue was the same in both groups and unadjusted for any baseline covariates.||0.64|-3.39|0.1815
70852810|NCT00096356|141194429|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.99|STANDARD_ERROR_OF_MEAN|2.31||0.3903|TWO_SIDED|95.0|-2.56|6.53||0.05 significance level; no multiple comparison adjustment|Mixed Models Analysis||This is the difference in treatment groups at 24 weeks (Co-Q10 minus Placebo). Higher is better for this outcome.|Constrained repeated measures analysis of variance - constrained to have equal means at baseline, unadjusted for other covariates||6.53|-2.56|.3903
70852811|NCT00096356|141194430|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|1.31||0.6014|TWO_SIDED|95.0|-3.25|1.88||0.05 significance level, unadjusted for multiple comparisons|Mixed Models Analysis||This is the difference between treatment groups at 24 weeks (Co-Q10 minus Placebo). Lower is better for this outcome.|Constrained repeated measures analysis of variance, constrained such that the baseline means are equal, unadjusted of other covariates||1.88|-3.25|.6014
70852812|NCT01008423|141194431|SUPERIORITY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Regression, Logistic|||The logistic regression test was used to test for a difference in the percentages between the 2 treatment arms after adjusting for analysis center (country).||||<0.0001
70852813|NCT00934843|141194458|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.78||||0.35|TWO_SIDED|95.0|0.45|1.33|||Multivariate risk computation|||The current study was designed with an anticipated enrollment of 87 patients per treatment arm to achieve a statistical power of 80% (1- β) while controlling type I error at 0.05 (α) using a more conservative estimate of LCOS rate in the Single Dose MP group of 33%, and an incidence of LCOS in the Two Dose MP group of 15%.||1.33|0.45|0.35
70852814|NCT00934843|141194459|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||A repeated measures analysis of variance framework was used for longitudinal analysis of inotrope score. In order to identify potential confounding variables, a variable was considered a relevant covariate and added into the model with a p ≤ 0.15.|ANCOVA|||||||0.43
70852815|NCT00934843|141194461|SUPERIORITY_OR_OTHER|||||||0.052||95.0||||Analysis of variance/covariance models were used to test both unadjusted and multivariable relationships between treatment groups for diuresis.|ANCOVA|||||||0.052
70852816|NCT00934843|141194462|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||ANCOVA|Analysis of variance/covariance models were used to test both unadjusted and multivariable relationships between treatment groups for diuresis.||||||0.047
70938979|NCT00657709|141378547|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|percentage group difference|-2.0|||||TWO_SIDED|95.0|-4.0|0.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV at 2, 4 and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% confidence interval for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL was, for the pneumococcal antigen PnC4.||0|-4|
71069928|NCT01340027|141648998|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.45|TWO_SIDED|95.0|0.7|2.25|||Regression, Logistic|||||2.25|0.70|0.45
71069929|NCT01340027|141648998|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.15||||0.64|TWO_SIDED|95.0|0.64|2.07|||Regression, Logistic|||||2.07|0.64|0.64
71069930|NCT01340027|141648998|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.16||||0.013|TWO_SIDED|95.0|1.18|3.94|||Regression, Logistic|||||3.94|1.18|0.013
71069931|NCT01340027|141648998|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.33||||0.017|TWO_SIDED|95.0|1.16|4.66|||Regression, Logistic|||||4.66|1.16|0.017
71113334|NCT05285644|141734293|OTHER|Difference (2-sided)|Least Squares Mean Difference|7.5|STANDARD_ERROR_OF_MEAN|0.76|<|0.0001|TWO_SIDED|95.0|6.0|9.0||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||9.0|6.0|<0.0001
71117685|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-0.96||||0.769|TWO_SIDED|95.0|-7.41|5.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||5.49|-7.41|0.769
70852817|NCT03456882|141194463|SUPERIORITY|||||||0.6346||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.6346
70938980|NCT00657709|141378547|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|2.0|||||TWO_SIDED|95.0|-4.0|8.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was, for PnC 6B antigen greater than -10%.||8|-4|
70938981|NCT00657709|141378547|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|0.0|||||TWO_SIDED|95.0|-2.0|1.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa\_HBV-IPV vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was, for PnC 9V, greater than -10%.||1|-2|
71069932|NCT01340027|141648998|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.74||||0.11|TWO_SIDED|95.0|0.88|3.45|||Regression, Logistic|||||3.45|0.88|0.11
71069933|NCT01340027|141649000|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.64||||0.52|TWO_SIDED|95.0|0.16|2.56|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||2.56|0.16|0.52
71069934|NCT01340027|141649000|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.67||||0.48|TWO_SIDED|95.0|0.23|1.99|||Regression, Logistic|||||1.99|0.23|0.48
71069935|NCT01340027|141649000|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.95||||0.93|TWO_SIDED|95.0|0.32|2.81|||Regression, Logistic|||||2.81|0.32|0.93
71069936|NCT01340027|141649000|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.12||||0.013|TWO_SIDED|95.0|1.47|25.6|||Regression, Logistic|||||25.60|1.47|0.013
71069937|NCT01340027|141649000|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.49||||0.031|TWO_SIDED|95.0|1.17|25.77|||Regression, Logistic|||||25.77|1.17|0.031
71069938|NCT01340027|141649000|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.84||||0.059|TWO_SIDED|95.0|0.95|15.58|||Regression, Logistic|||||15.58|0.95|0.059
71069939|NCT01340027|141649000|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.91||||0.36|TWO_SIDED|95.0|0.48|7.58|||Regression, Logistic|||||7.58|0.48|0.36
71069940|NCT01340027|141649000|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.34||||0.26|TWO_SIDED|95.0|0.05|2.17|||Regression, Logistic|||||2.17|0.05|0.26
71069941|NCT01340027|141649000|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.43||||0.33|TWO_SIDED|95.0|0.08|2.31|||Regression, Logistic|||||2.31|0.08|0.33
71069942|NCT01340027|141649000|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.07||||0.94|TWO_SIDED|95.0|0.17|6.68|||Regression, Logistic|||||6.68|0.17|0.94
71069943|NCT01340027|141649000|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.44||||0.29|TWO_SIDED|95.0|0.09|2.02|||Regression, Logistic|||||2.02|0.09|0.29
71069944|NCT01340027|141649000|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.28||||0.15|TWO_SIDED|95.0|0.05|1.6|||Regression, Logistic|||||1.60|0.05|0.15
71069945|NCT01340027|141649000|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.29||||0.11|TWO_SIDED|95.0|0.06|1.34|||Regression, Logistic|||||1.34|0.06|0.11
71069946|NCT01340027|141649000|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.41||||0.26|TWO_SIDED|95.0|0.09|1.89|||Regression, Logistic|||||1.89|0.09|0.26
71069947|NCT01340027|141649000|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.67||||0.28|TWO_SIDED|95.0|0.44|16.17|||Regression, Logistic|||||16.17|0.44|0.28
71069948|NCT01340027|141649000|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.39||||0.36|TWO_SIDED|95.0|0.37|15.46|||Regression, Logistic|||||15.46|0.37|0.36
71069949|NCT01340027|141649000|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.68||||0.56|TWO_SIDED|95.0|0.29|9.72|||Regression, Logistic|||||9.72|0.29|0.56
71069950|NCT01340027|141649000|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.83||||0.84|TWO_SIDED|95.0|0.15|4.76|||Regression, Logistic|||||4.76|0.15|0.84
71069951|NCT01340027|141649001|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.61||||0.48|TWO_SIDED|95.0|0.16|2.38|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||2.38|0.16|0.48
71069952|NCT01340027|141649001|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.74||||0.58|TWO_SIDED|95.0|0.25|2.17|||Regression, Logistic|||||2.17|0.25|0.58
71069953|NCT01340027|141649001|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||0.93|TWO_SIDED|95.0|0.34|3.28|||Regression, Logistic|||||3.28|0.34|0.93
71069954|NCT01340027|141649001|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|12.16||||0.023|TWO_SIDED|95.0|1.4|105.3|||Regression, Logistic|||||105.30|1.40|0.023
71069955|NCT01340027|141649001|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|9.48||||0.042|TWO_SIDED|95.0|1.08|83.24|||Regression, Logistic|||||83.24|1.08|0.042
70938982|NCT00657709|141378547|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|0.0|||||TWO_SIDED|95.0|-4.0|3.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 vaccine when given concomitantly with rMenB and DTPa-HBV-IPV at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was, for PnC14 antigen, greater than -10%.||3|-4|
70938983|NCT00657709|141378547|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-3.0|1.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was, for PnC 18C antigen greater than -10%.||1|-3|
70938984|NCT00657709|141378547|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|0.0|||||TWO_SIDED|95.0|-3.0|4.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV vaccine at 2, 4 and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was for PnC 19F antigen, greater than -10%.||4|-3|
71069956|NCT01340027|141649001|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|9.03||||0.047|TWO_SIDED|95.0|1.03|79.19|||Regression, Logistic|||||79.19|1.03|0.047
71069957|NCT01340027|141649001|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.79||||0.23|TWO_SIDED|95.0|0.52|14.9|||Regression, Logistic|||||14.90|0.52|0.23
71069958|NCT01340027|141649001|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.1||||0.058|TWO_SIDED|95.0|0.01|1.08|||Regression, Logistic|||||1.08|0.01|0.058
71069959|NCT01340027|141649001|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.18||||0.15|TWO_SIDED|95.0|0.02|1.87|||Regression, Logistic|||||1.87|0.02|0.15
71069960|NCT01340027|141649001|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.46||||0.55|TWO_SIDED|95.0|0.04|5.99|||Regression, Logistic|||||5.99|0.04|0.55
71069961|NCT01340027|141649001|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.16||||0.11|TWO_SIDED|95.0|0.02|1.48|||Regression, Logistic|||||1.48|0.02|0.11
71069962|NCT01340027|141649001|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.1||||0.054|TWO_SIDED|95.0|0.01|1.05|||Regression, Logistic|||||1.05|0.01|0.054
71069963|NCT01340027|141649001|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.12||||0.059|TWO_SIDED|95.0|0.01|1.08|||Regression, Logistic|||||1.08|0.01|0.059
71069964|NCT01340027|141649001|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.17||||0.12|TWO_SIDED|95.0|0.02|1.58|||Regression, Logistic|||||1.58|0.02|0.12
71069965|NCT01340027|141649001|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.0||||0.64|TWO_SIDED|95.0|0.11|35.46|||Regression, Logistic|||||35.46|0.11|0.64
71069966|NCT01340027|141649001|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.56||||0.76|TWO_SIDED|95.0|0.09|27.42|||Regression, Logistic|||||27.42|0.09|0.76
71069967|NCT01340027|141649001|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.49||||0.79|TWO_SIDED|95.0|0.08|26.47|||Regression, Logistic|||||26.47|0.08|0.79
71069968|NCT01340027|141649001|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.46||||0.55|TWO_SIDED|95.0|0.04|5.77|||Regression, Logistic|||||5.77|0.04|0.55
71069969|NCT01340027|141649002|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.495||0.25|TWO_SIDED|95.0|-1.24|0.71||All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.|Stratified Rank ANCOVA|P-values are from pairwise comparisons of the combination/active treatment groups vs. solifenacin 5 mg/placebo within a stratified rank ANCOVA model.||The ANCOVA model including the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and Baseline measurement as a covariate was used to calculate point estimates and 95% confidence intervals for change from Baseline within each treatment group and for differences between combination treatment groups and solifenacin 5 mg as well as for differences between active treatment groups and placebo.||0.71|-1.24|0.25
71069970|NCT01340027|141649002|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.383||0.35|TWO_SIDED|95.0|-0.7|0.81|||Stratified Rank ANCOVA|||||0.81|-0.70|0.35
71069971|NCT01340027|141649002|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.371||1|TWO_SIDED|95.0|-0.74|0.72|||Stratified Rank ANCOVA|||||0.72|-0.74|1.0
71069972|NCT01340027|141649002|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.377||0.003|TWO_SIDED|95.0|-1.08|0.41|||Stratified Rank ANCOVA|||||0.41|-1.08|0.003
71069973|NCT01340027|141649002|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.413||0.12|TWO_SIDED|95.0|-1.04|0.59|||Stratified Rank ANCOVA|||||0.59|-1.04|0.12
71069974|NCT01340027|141649002|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.405||0.24|TWO_SIDED|95.0|-0.21|1.38|||Stratified Rank ANCOVA|||||1.38|-0.21|0.24
71113335|NCT05285644|141734294|OTHER|Difference (2-sided)|Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|2.28||0.2184|TWO_SIDED|95.0|-7.3|1.7||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||1.7|-7.3|0.2184
71117686|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-71.19|||<|0.001|TWO_SIDED|95.0|-88.0|-54.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-54.38|-88.00|<0.001
71113336|NCT05285644|141734295|OTHER|Difference (2-sided)|Least Squares Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|2.43||0.266|TWO_SIDED|94.0|-7.5|2.1||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||2.1|-7.5|0.2660
71117687|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-66.99|||<|0.001|TWO_SIDED|95.0|-84.26|-49.72||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-49.72|-84.26|<0.001
71117688|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-67.47|||<|0.001|TWO_SIDED|95.0|-84.75|-50.19||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-50.19|-84.75|<0.001
71117689|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-62.76|||<|0.001|TWO_SIDED|95.0|-80.45|-45.07||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-45.07|-80.45|<0.001
71029079|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.146|TWO_SIDED|95.0|0.54|1.09||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 195 and 210 minutes postdose||1.09|0.54|0.146
71029080|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.702|TWO_SIDED|95.0|0.69|1.29||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 195 and 210 minutes postdose||1.29|0.69|0.702
71029081|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.228|TWO_SIDED|95.0|0.88|1.69||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 195 and 210 minutes postdose||1.69|0.88|0.228
71029082|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.13|TWO_SIDED|95.0|0.51|1.09||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 210 and 225 minutes postdose||1.09|0.51|0.130
71029083|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.371|TWO_SIDED|95.0|0.6|1.21||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 210 and 225 minutes postdose||1.21|0.60|0.371
71029084|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.43|TWO_SIDED|95.0|0.82|1.58||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 210 and 225 minutes postdose||1.58|0.82|0.430
71029085|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.177|TWO_SIDED|95.0|0.51|1.13||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 225 and 240 minutes postdose||1.13|0.51|0.177
71029086|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.58|TWO_SIDED|95.0|0.64|1.28||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 225 and 240 minutes postdose||1.28|0.64|0.580
71029087|NCT01062256|141565696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.333|TWO_SIDED|95.0|0.84|1.7||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 225 and 240 minutes postdose||1.70|0.84|0.333
71029088|NCT01062256|141565697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.264|TWO_SIDED|95.0|-0.08|0.27||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 1 hour postdose||0.27|-0.08|0.264
71029089|NCT01062256|141565697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.737|TWO_SIDED|95.0|-0.2|0.14||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 1 hour postdose||0.14|-0.20|0.737
71029090|NCT01062256|141565697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.078|TWO_SIDED|95.0|-0.27|0.01||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 1 hour postdose||0.01|-0.27|0.078
71113337|NCT05285644|141734296|OTHER|Difference (2-sided)|Least Squares Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|2.37||0.2741|TWO_SIDED|95.0|-7.2|2.0||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||2.0|-7.2|0.2741
71029091|NCT01062256|141565697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.125|TWO_SIDED|95.0|-0.04|0.36||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 2 hour postdose||0.36|-0.04|0.125
71113338|NCT05285644|141734297|OTHER|Difference (2-sided)|Least Squares Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|2.43||0.159|TWO_SIDED|95.0|-8.2|1.3||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||1.3|-8.2|0.1590
71069975|NCT01340027|141649002|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.435||0.54|TWO_SIDED|95.0|-0.94|0.78|||Stratified Rank ANCOVA|||||0.78|-0.94|0.54
71113339|NCT05285644|141734298|OTHER|Difference (2-sided)|Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|2.67||0.1369|TWO_SIDED|95.0|-9.2|1.3||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||1.3|-9.2|0.1369
71113340|NCT01696981|141734325|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.95|1.0|||Poisson regression|||||1.00|0.95|
71113341|NCT01696981|141734327|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.72|0.85|||Poisson regression|||||0.85|0.72|
71113342|NCT01696981|141734329|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.63|0.87|||Poisson regression|||||0.87|0.63|
71113343|NCT03335150|141734348|OTHER|Equality|Mean Difference (Final Values)|0.4856||||0.6662|TWO_SIDED|||||Interaction term|Mixed Models Analysis||Estimated Value = Standard Error (SE) of the interaction term.|||||0.6662
71113344|NCT03335150|141734348|OTHER|Equality|Mean Difference (Final Values)|0.2415||||0.1617|TWO_SIDED||||||Mixed Models Analysis|Mean Matrix Reasoning Total (MRT) difference between two visits while controlling for intervention.|estimated value = SE|||||0.1617
71069976|NCT01340027|141649002|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.59||0.95|TWO_SIDED|95.0|-1.1|1.22|||Stratified Rank ANCOVA|||||1.22|-1.10|0.95
71113345|NCT03335150|141734348|OTHER|Equality|Mean Difference (Final Values)|0.5087||||0.6236|TWO_SIDED||||||Mixed Models Analysis|Mean MRT difference between two interventions while controlling for visit.|estimated value = SE|||||0.6236
71069977|NCT01340027|141649002|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.552||0.74|TWO_SIDED|95.0|-1.11|1.07|||Stratified Rank ANCOVA|||||1.07|-1.11|0.74
71069978|NCT01340027|141649002|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.57||0.89|TWO_SIDED|95.0|-1.43|0.82|||Stratified Rank ANCOVA|||||0.82|-1.43|0.89
71113346|NCT03335150|141734349|OTHER|Equality|Mean Difference (Final Values)|0.58||||0.0496|TWO_SIDED|||||Interaction term|Mixed Models Analysis||Estimated value = SE of interaction term|||||0.0496
71113347|NCT03335150|141734350|OTHER|Equality|Mean Difference (Final Values)|1.62||||0.047|TWO_SIDED|||||Interaction term|Mixed Models Analysis||Estimated Value = SE of interaction term|||||0.047
71113348|NCT03335150|141734351|OTHER|Equality|Mean Difference (Final Values)|2.97||||0.001|TWO_SIDED|||||Interaction Term|Mixed Models Analysis||Estimated Value = SE of interaction term|||||0.001
71069979|NCT01340027|141649002|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.487||0.82|TWO_SIDED|95.0|-0.96|0.96|||Stratified Rank ANCOVA|||||0.96|-0.96|0.82
71069980|NCT01340027|141649002|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.593||0.58|TWO_SIDED|95.0|-1.44|0.9|||Stratified Rank ANCOVA|||||0.90|-1.44|0.58
71069981|NCT01340027|141649002|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.5||0.46|TWO_SIDED|95.0|-0.93|1.04|||Stratified Rank ANCOVA|||||1.04|-0.93|0.46
71069982|NCT01340027|141649002|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.49||0.95|TWO_SIDED|95.0|-0.97|0.96|||Stratified Rank ANCOVA|||||0.96|-0.97|0.95
71069983|NCT01340027|141649002|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.499||0.18|TWO_SIDED|95.0|-1.32|0.65|||Stratified Rank ANCOVA|||||0.65|-1.32|0.18
71069984|NCT01340027|141649002|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.517||0.21|TWO_SIDED|95.0|-1.24|0.8|||Stratified Rank ANCOVA|||||0.80|-1.24|0.21
71069985|NCT01340027|141649002|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.516||0.72|TWO_SIDED|95.0|-0.43|1.6|||Stratified Rank ANCOVA|||||1.60|-0.43|0.72
71069986|NCT01340027|141649002|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.541||0.92|TWO_SIDED|95.0|-1.15|0.98|||Stratified Rank ANCOVA|||||0.98|-1.15|0.92
71113349|NCT03335150|141734352|OTHER|Equality|Mean Difference (Final Values)|2.25||||0.02|TWO_SIDED|||||Interaction term|Mixed Models Analysis||Estimated Value = SE of interaction term|||||0.020
71113350|NCT03335150|141734353|OTHER|Equality|Mean Difference (Final Values)|1.26||||0.444|TWO_SIDED|||||Interaction term|Mixed Models Analysis||Estimated Value = SE of interaction term|||||0.444
71113351|NCT03335150|141734353|OTHER|Equality|Mean Difference (Final Values)|1.145||||0.0233|TWO_SIDED||||||Mixed Models Analysis|There is significant difference in MIST between intervention groups controlling for visit and other significant covariates.|estimated value = SE|||||0.0233
71113352|NCT03335150|141734353|OTHER|Equality|Mean Difference (Final Values)|0.6281|||<|0|TWO_SIDED||||||Mixed Models Analysis|There is significant difference in MIST between baseline and week 10 controlling for intervention group and other significant covariates|estimated value = SE|||||<0.000
71113353|NCT03335150|141734354|OTHER|Equality|Mean Difference (Final Values)|2.205||||0.073|TWO_SIDED|||||Interaction term|Mixed Models Analysis||estimated value = SE of interaction term|||||0.073
71113354|NCT03335150|141734355|OTHER|Equality|Mean Difference (Final Values)|2.25||||0.82|TWO_SIDED|||||Interaction Term|Mixed Models Analysis|||||||0.82
71113355|NCT03335150|141734355|OTHER|Equality|Mean Difference (Final Values)|1.1172||||0.0257|TWO_SIDED||||||Mixed Models Analysis|Mean PDQ-39 difference between baseline and week 10 controlling for intervention and covariates.|estimated value = SE|||||0.0257
71113356|NCT03335150|141734355|OTHER|Equality|Mean Difference (Final Values)|3.8649||||0.1101|TWO_SIDED||||||Mixed Models Analysis|Difference in PDQ-39 between two interventions controlling for visit and covariates.|estimated value = SE|||||0.1101
71113357|NCT03335150|141734356|OTHER|Equality|Median Difference (Final Values)|1.784||||0.0263|TWO_SIDED|||||Interaction term|Mixed Models Analysis||Estimated Value = SE of the interaction term.|||||0.0263
71113358|NCT02907216|141734377|NON_INFERIORITY|Criteria for non-inferiority: The Lower Limit (LL) of the standardised asymptotic 95% Confidence Interval (CI) on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective concentrations ≥ 0.1 IU/mL for anti-D antibodies should be ≥ -10%.|Difference-Seroprotective concentration|0.0|||||TWO_SIDED|95.0|-2.66|2.74|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-D antibody concentration ≥ 0.1 IU/mL.||2.74|-2.66|
71113359|NCT02907216|141734377|NON_INFERIORITY|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective concentrations ≥ 0.1 IU/mL for anti-T antibodies should be ≥ -10%.|Difference-Seroprotective concentration|-0.69|||||TWO_SIDED|95.0|-4.39|2.71|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-T antibody concentration ≥ 0.1 IU/mL.||2.71|-4.39|
71113360|NCT02907216|141734378|NON_INFERIORITY|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective concentrations ≥ 10 IU/mL for anti-PT antibodies should be ≥ -10%.|Difference-Seroprotective concentration|2.99|||||TWO_SIDED|95.0|-2.7|9.12|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-PT antibody concentration ≥ 10 IU/mL.||9.12|-2.7|
71069987|NCT01340027|141649003|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.412||0.002|TWO_SIDED|95.0|-2.06|-0.45|||ANCOVA|||"All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||-0.45|-2.06|0.002
71113361|NCT02907216|141734378|NON_INFERIORITY|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective concentrations ≥ 10 IU/mL for anti-FHA antibodies should be ≥ -10%.|Difference-Seroprotective concentration|0.0|||||TWO_SIDED|95.0|-2.66|2.72|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-FHA antibody concentration ≥ 10 IU/mL.||2.72|-2.66|
71069988|NCT01340027|141649003|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.34||0.16|TWO_SIDED|95.0|-1.15|0.19|||ANCOVA|||||0.19|-1.15|0.16
71117690|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-8.53||||0.021|TWO_SIDED|95.0|-15.55|-1.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-1.50|-15.55|0.021
71069989|NCT01340027|141649003|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-1.91|-0.57|||ANCOVA|||||-0.57|-1.91|<0.001
71069990|NCT01340027|141649003|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.343||0.001|TWO_SIDED|95.0|-1.8|-0.46|||ANCOVA|||||-0.46|-1.80|0.001
70938985|NCT00657709|141378547|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-3.0|||||TWO_SIDED|95.0|-8.0|2.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was for PnC 23F antigen, greater than -10%.||2|-8|
70938986|NCT00657709|141378548|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-3.0|||||TWO_SIDED|95.0|-9.0|4.0|||Miettinen and Nurminen|||Immunogenicity of the FHA antigen of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 vaccine at 2, 4 and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects was greater than -10%.||4|-9|
70938987|NCT00657709|141378548|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-9.0|||||TWO_SIDED|95.0|-16.0|-3.0|||Miettinen and Nurminen|||Immunogenicity of the Pertactin antigen of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 at 2, 4 and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects was greater than -10%.||-3|-16|
71029092|NCT01062256|141565697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.688|TWO_SIDED|95.0|-0.16|0.24||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 2 hour postdose||0.24|-0.16|0.688
71029093|NCT01062256|141565697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.166|TWO_SIDED|95.0|-0.29|0.05||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 2 hour postdose||0.05|-0.29|0.166
71069991|NCT01340027|141649003|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.37|STANDARD_ERROR_OF_MEAN|0.338|<|0.001|TWO_SIDED|95.0|-2.03|-0.7|||ANCOVA|||||-0.70|-2.03|<0.001
71069992|NCT01340027|141649003|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.409||0.017|TWO_SIDED|95.0|-1.78|-0.18|||ANCOVA|||||-0.18|-1.78|0.017
71069993|NCT01340027|141649003|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.405||0.004|TWO_SIDED|95.0|-1.98|-0.39|||ANCOVA|||||-0.39|-1.98|0.004
71069994|NCT01340027|141649003|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.469||0.53|TWO_SIDED|95.0|-0.63|1.22|||ANCOVA|||||1.22|-0.63|0.53
71069995|NCT01340027|141649003|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.468||0.85|TWO_SIDED|95.0|-0.83|1.01|||ANCOVA|||||1.01|-0.83|0.85
71069996|NCT01340027|141649003|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.468||0.84|TWO_SIDED|95.0|-1.01|0.83|||ANCOVA|||||0.83|-1.01|0.84
71069997|NCT01340027|141649003|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.406||0.05|TWO_SIDED|95.0|0.0|1.59|||ANCOVA|||||1.59|-0.00|0.050
71113362|NCT02907216|141734379|NON_INFERIORITY|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective titers ≥ 8 ED50 for anti-polio 1 antibodies should be ≥ -10%.|Difference in seroprotective titer|0.0|||||TWO_SIDED|95.0|-2.68|2.74|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-polio 1 seroprotective titres ≥ 8 ED50.||2.74|-2.68|
71029094|NCT01062256|141565697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.233|TWO_SIDED|95.0|-0.09|0.35||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 3 hour postdose||0.35|-0.09|0.233
71029095|NCT01062256|141565697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.848|TWO_SIDED|95.0|-0.24|0.19||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 3 hour postdose||0.19|-0.24|0.848
71069998|NCT01340027|141649003|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.469||0.33|TWO_SIDED|95.0|-1.38|0.46|||ANCOVA|||||0.46|-1.38|0.33
71069999|NCT01340027|141649003|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.407||0.44|TWO_SIDED|95.0|-0.48|1.12|||ANCOVA|||||1.12|-0.48|0.44
71070000|NCT01340027|141649003|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.408||0.28|TWO_SIDED|95.0|-1.24|0.36|||ANCOVA|||||0.36|-1.24|0.28
71070001|NCT01340027|141649003|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.41||0.42|TWO_SIDED|95.0|-1.14|0.47|||ANCOVA|||||0.47|-1.14|0.42
71070002|NCT01340027|141649003|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.406||0.16|TWO_SIDED|95.0|-1.37|0.23|||ANCOVA|||||0.23|-1.37|0.16
71070003|NCT01340027|141649003|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.467||0.7|TWO_SIDED|95.0|-1.1|0.73|||ANCOVA|||||0.73|-1.10|0.70
71070004|NCT01340027|141649003|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.464||0.4|TWO_SIDED|95.0|-1.3|0.52|||ANCOVA|||||0.52|-1.30|0.40
71070005|NCT01340027|141649004|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.079||0.062|TWO_SIDED|95.0|-0.3|0.01|||ANCOVA|||"All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||0.01|-0.30|0.062
71070006|NCT01340027|141649004|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.065||0.15|TWO_SIDED|95.0|-0.22|0.03|||ANCOVA|||||0.03|-0.22|0.15
71070007|NCT01340027|141649004|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.065||0.007|TWO_SIDED|95.0|-0.3|-0.05|||ANCOVA|||||-0.05|-0.30|0.007
70938988|NCT00657709|141378548|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-2.0|||||TWO_SIDED|95.0|-7.0|2.0|||Miettinen and Nurminen|||Immunogenicity of the PT antigen of DTPa-HBV-IPV vaccine given concomitantly with rMenB and PCV7 vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects was greater than -10%.||2|-7|
70938989|NCT00901459|141378552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.47|STANDARD_ERROR_OF_MEAN|0.44||0.014|TWO_SIDED|95.0|0.51|2.43||A Holm correction to p values was made to control for type 1 error.|t-test, 2 sided|df=14|The parameter estimated is the difference in craving change between smoking cues and neutral cues in the 10Hz sfg condition (Frequency control)and the corresponding craving change in the 1Hz sfg condition (active).|A pairwise t-test was performed to contrast the active rTMS condition with the frequency control condition.||2.43|0.51|0.014
71070008|NCT01340027|141649004|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.066||0.017|TWO_SIDED|95.0|-0.29|-0.03|||ANCOVA|||||-0.03|-0.29|0.017
71070009|NCT01340027|141649004|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.065|<|0.001|TWO_SIDED|95.0|-0.35|-0.1|||ANCOVA|||||-0.10|-0.35|<0.001
71070010|NCT01340027|141649004|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.078|<|0.001|TWO_SIDED|95.0|-0.41|-0.11|||ANCOVA|||||-0.11|-0.41|<0.001
71070011|NCT01340027|141649004|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.077||0.07|TWO_SIDED|95.0|-0.29|0.01|||ANCOVA|||||0.01|-0.29|0.070
71070012|NCT01340027|141649004|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.09||0.15|TWO_SIDED|95.0|-0.05|0.31|||ANCOVA|||||0.31|-0.05|0.15
71070013|NCT01340027|141649004|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.089||0.57|TWO_SIDED|95.0|-0.12|0.23|||ANCOVA|||||0.23|-0.12|0.57
71070014|NCT01340027|141649004|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.089||0.89|TWO_SIDED|95.0|-0.16|0.19|||ANCOVA|||||0.19|-0.16|0.89
71070015|NCT01340027|141649004|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.077||0.086|TWO_SIDED|95.0|-0.02|0.29|||ANCOVA|||||0.29|-0.02|0.086
71070016|NCT01340027|141649004|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.09||0.88|TWO_SIDED|95.0|-0.19|0.16|||ANCOVA|||||0.16|-0.19|0.88
71070017|NCT01340027|141649004|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.078||0.61|TWO_SIDED|95.0|-0.11|0.19|||ANCOVA|||||0.19|-0.11|0.61
71070018|NCT01340027|141649004|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.078||0.58|TWO_SIDED|95.0|-0.2|0.11|||ANCOVA|||||0.11|-0.20|0.58
71070019|NCT01340027|141649004|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.078||0.76|TWO_SIDED|95.0|-0.18|0.13|||ANCOVA|||||0.13|-0.18|0.76
71070020|NCT01340027|141649004|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_DEVIATION|0.077||0.23|TWO_SIDED|95.0|-0.25|0.06|||ANCOVA|||||0.06|-0.25|0.23
71070021|NCT01340027|141649004|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.089||0.15|TWO_SIDED|95.0|-0.3|0.05|||ANCOVA|||||0.05|-0.30|0.15
71070022|NCT01340027|141649004|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.088||0.94|TWO_SIDED|95.0|-0.18|0.17|||ANCOVA|||||0.17|-0.18|0.94
71070023|NCT01340027|141649005|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.33||0.29|TWO_SIDED|95.0|-0.99|0.3|||ANCOVA|||"All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||0.30|-0.99|0.29
71070024|NCT01340027|141649005|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.35|STANDARD_ERROR_OF_MEAN|0.239||0.15|TWO_SIDED|95.0|-0.12|0.82|||ANCOVA|||||0.82|-0.12|0.15
71070025|NCT01340027|141649005|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.248||0.99|TWO_SIDED|95.0|-0.48|0.49|||ANCOVA|||||0.49|-0.48|0.99
71070026|NCT01340027|141649005|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.239||0.76|TWO_SIDED|95.0|-0.54|0.4|||ANCOVA|||||0.40|-0.54|0.76
71070027|NCT01340027|141649005|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.238||0.3|TWO_SIDED|95.0|-0.71|0.22|||ANCOVA|||||0.22|-0.71|0.30
71070028|NCT01340027|141649005|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.262||0.43|TWO_SIDED|95.0|-0.72|0.31|||ANCOVA|||||0.31|-0.72|0.43
71070029|NCT01340027|141649005|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.296||0.4|TWO_SIDED|95.0|-0.83|0.33|||ANCOVA|||||0.33|-0.83|0.40
71070030|NCT01340027|141649005|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.343||0.24|TWO_SIDED|95.0|-1.08|0.27|||ANCOVA|||||0.27|-1.08|0.24
71070031|NCT01340027|141649005|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.34||0.36|TWO_SIDED|95.0|-0.98|0.36|||ANCOVA|||||0.36|-0.98|0.36
71070032|NCT01340027|141649005|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.348||0.02|TWO_SIDED|95.0|-1.49|-0.13|||ANCOVA|||||-0.13|-1.49|0.020
71070033|NCT01340027|141649005|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.293||0.011|TWO_SIDED|95.0|-1.33|-0.18|||ANCOVA|||||-0.18|-1.33|0.011
70938990|NCT00901459|141378552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.4||0.49|TWO_SIDED|95.0|-0.64|1.22|||t-test, 2 sided|df=13|The parameter estimated is the difference in craving change between smoking cues and neutral cues in the 1Hz sfg condition (active)and the corresponding craving change in the 1Hz moc condition (location control).|A pairwise t-test was performed to contrast the active rTMS condition with the location control condition.||1.22|-0.64|0.49
71070034|NCT01340027|141649005|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.377||0.004|TWO_SIDED|95.0|-1.84|-0.36|||ANCOVA|||||-0.36|-1.84|0.004
71070035|NCT01340027|141649005|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.301||0.18|TWO_SIDED|95.0|-1.0|0.19|||ANCOVA|||||0.19|-1.00|0.18
71070036|NCT01340027|141649005|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.308||0.015|TWO_SIDED|95.0|-1.35|-0.14|||ANCOVA|||||-0.14|-1.35|0.015
71070037|NCT01340027|141649005|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.301||0.006|TWO_SIDED|95.0|-1.41|-0.23|||ANCOVA|||||-0.23|-1.41|0.006
71070038|NCT01340027|141649005|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.59|-0.41|||ANCOVA|||||-0.41|-1.59|<0.001
71070039|NCT01340027|141649005|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.32||0.003|TWO_SIDED|95.0|-1.59|-0.33|||ANCOVA|||||-0.33|-1.59|0.003
71070040|NCT01340027|141649005|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.348||0.004|TWO_SIDED|95.0|-1.68|-0.31|||ANCOVA|||||-0.31|-1.68|0.004
71070041|NCT01340027|141649006|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.177||0.15|TWO_SIDED|95.0|-0.6|0.09|||ANCOVA|||"All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||0.09|-0.60|0.15
71070042|NCT01340027|141649006|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.146||0.78|TWO_SIDED|95.0|-0.33|0.25|||ANCOVA|||||0.25|-0.33|0.78
71070043|NCT01340027|141649006|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.146||0.58|TWO_SIDED|95.0|-0.37|0.21|||ANCOVA|||||0.21|-0.37|0.58
71113363|NCT02907216|141734379|NON_INFERIORITY|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective titers ≥ 8 ED50 for anti-polio 2 antibodies should be ≥ -10%.|Difference in seroprotective titer|0.0|||||TWO_SIDED|95.0|-2.92|2.95|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-polio 2 seroprotective titres ≥ 8 ED50.||2.95|-2.92|
71113364|NCT02907216|141734379|NON_INFERIORITY|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective titers ≥ 8 ED50 for anti-polio 3 antibodies should be ≥ -10%.|Difference in seroprotective titer|0.81|||||TWO_SIDED|95.0|-2.04|4.47|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-polio 3 seroprotective titres ≥ 8 ED50.||4.47|-2.04|
71117691|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-3.99||||0.337|TWO_SIDED|95.0|-12.05|4.07||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.07|-12.05|0.337
71070044|NCT01340027|141649006|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.147||0.6|TWO_SIDED|95.0|-0.37|0.21|||ANCOVA|||||0.21|-0.37|0.60
71070045|NCT01340027|141649006|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.145||0.017|TWO_SIDED|95.0|-0.63|-0.06|||ANCOVA|||||-0.06|-0.63|0.017
71070046|NCT01340027|141649006|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.176||0.16|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||||0.10|-0.60|0.16
71070047|NCT01340027|141649006|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.175||0.13|TWO_SIDED|95.0|-0.61|0.08|||ANCOVA|||||0.08|-0.61|0.13
71070048|NCT01340027|141649006|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.201||0.81|TWO_SIDED|95.0|-0.35|0.44|||ANCOVA|||||0.44|-0.35|0.81
71070049|NCT01340027|141649006|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.199||0.67|TWO_SIDED|95.0|-0.48|0.31|||ANCOVA|||||0.31|-0.48|0.67
71070050|NCT01340027|141649006|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.2||0.77|TWO_SIDED|95.0|-0.33|0.45|||ANCOVA|||||0.45|-0.33|0.77
71070051|NCT01340027|141649006|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.81||0.81|TWO_SIDED|95.0|-0.3|0.38|||ANCOVA|||||0.38|-0.30|0.81
71070052|NCT01340027|141649006|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.201||0.3|TWO_SIDED|95.0|-0.6|0.18|||ANCOVA|||||0.18|-0.60|0.30
71070053|NCT01340027|141649006|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.174||0.99|TWO_SIDED|95.0|-0.34|0.34|||ANCOVA|||||0.34|-0.34|0.99
71070054|NCT01340027|141649006|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.175||0.82|TWO_SIDED|95.0|-0.38|0.3|||ANCOVA|||||0.30|-0.38|0.82
71070055|NCT01340027|141649006|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.175||0.84|TWO_SIDED|95.0|-0.38|0.31|||ANCOVA|||||0.31|-0.38|0.84
71070056|NCT01340027|141649006|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.173||0.08|TWO_SIDED|95.0|-0.64|0.04|||ANCOVA|||||0.04|-0.64|0.080
71070057|NCT01340027|141649006|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.2||0.3|TWO_SIDED|95.0|-0.6|0.18|||ANCOVA|||||0.18|-0.60|0.30
71070058|NCT01340027|141649006|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.199||0.26|TWO_SIDED|95.0|-0.62|0.17|||ANCOVA|||||0.17|-0.62|0.26
71029096|NCT01062256|141565697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.093|TWO_SIDED|95.0|-0.33|0.03||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 3 hour postdose||0.03|-0.33|0.093
71113365|NCT01433042|141734460|SUPERIORITY_OR_OTHER||percentage|98.0||||||||||since the study results analysis is purley discriptive no P value and confidence interval was used for the analysis|percentage|percentage of SB3 images graded as superior in image quality to SB2|since the study results analysis is purley discriptive no P value and confidence interval was used for the analysis|"Primary Endpoint~o Physician's subjective assessment questionnaire was evaluated in a quality manner.~The physicians were required to assess the performance of SB3 system as compare to SB2 by answering a short questionnaire.~The physicians were requested to indicate whether capsule SB3 was better as compared to SB2."||||
71113366|NCT06899737|141734472|SUPERIORITY||Mean Difference (Final Values)|-2.55|STANDARD_ERROR_OF_MEAN|2.56||0.32|TWO_SIDED|95.0|-7.64|2.55|||t-test, 2 sided|||||2.55|-7.64|0.32
71113367|NCT06899737|141734473|SUPERIORITY||Mean Difference (Final Values)|4.18|STANDARD_ERROR_OF_MEAN|3.08||0.18|TWO_SIDED|95.0|-1.94|10.3|||t-test, 2 sided|||||10.30|-1.94|0.18
71113368|NCT06899737|141734474|SUPERIORITY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.5||0.71|TWO_SIDED|95.0|-0.81|1.18|||t-test, 2 sided|||||1.18|-0.81|0.71
71113369|NCT06899737|141734475|SUPERIORITY||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.32||0.32|TWO_SIDED|95.0|-0.03|1.24|||t-test, 2 sided|||||1.24|-0.03|0.32
71113370|NCT06899737|141734476|SUPERIORITY||Median Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.44||0.91|TWO_SIDED|95.0|-0.82|0.92|||t-test, 2 sided|||||0.92|-0.82|0.91
71113371|NCT06899737|141734477|SUPERIORITY||Median Difference (Final Values)|0.69||||0.059|TWO_SIDED|95.0|-0.03|1.42|||t-test, 2 sided|||||1.42|-0.03|0.059
71113372|NCT06899737|141734478|SUPERIORITY||Median Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.41||0.79|TWO_SIDED|95.0|-0.92|0.71|||t-test, 2 sided|||||0.71|-0.92|0.79
71113373|NCT06899737|141734479|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.33||0.14|TWO_SIDED|95.0|-0.16|1.15|||t-test, 2 sided|||||1.15|-0.16|0.14
71029097|NCT01062256|141565697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.406|TWO_SIDED|95.0|-0.14|0.34||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 4 hour postdose||0.34|-0.14|0.406
71029098|NCT01062256|141565697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.991|TWO_SIDED|95.0|-0.24|0.24||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 4 hour postdose||0.24|-0.24|0.991
71029099|NCT01062256|141565697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.306|TWO_SIDED|95.0|-0.3|0.09||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 4 hour postdose||0.09|-0.30|0.306
71029100|NCT01062256|141565698|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma statistic|0.15||||0.254|TWO_SIDED|95.0|-0.09|0.39||p-values from Cochran-Mantel-Haenszel test with modified ridit scores, controlling for gender, time stratum, and site.|Cochran-Mantel-Haenszel|||Pairwise comparison of global evaluation of study medication.||0.39|-0.09|0.254
71029101|NCT01062256|141565698|SUPERIORITY_OR_OTHER||weighted Goodman-Kruskal Gamma statistic|-0.01||||0.949|TWO_SIDED|95.0|-0.25|0.23||p-values from Cochran-Mantel-Haenszel test with modified ridit scores, controlling for gender, time stratum, and site.|Cochran-Mantel-Haenszel|||Pairwise comparison of global evaluation of study medication.||0.23|-0.25|0.949
70938991|NCT00901459|141378552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.95|STANDARD_ERROR_OF_MEAN|0.44||0.09|TWO_SIDED|95.0|0.52|1.39||A Holm correction to p values was made to control for type 1 error.|t-test, 2 sided|df=13|The parameter estimated is the difference in craving change between smoking cues and neutral cues in the 10Hz sfg condition (frequency control)and the corresponding craving change in the 1Hz moc condition (location control).|A pairwise t-test was performed to contrast the location control rTMS condition with the frequency control condition.||1.39|0.52|0.09
71070059|NCT01340027|141649007|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.38|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||0.2|-0.5|0.38
71113374|NCT06899737|141734480|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.43||0.42|TWO_SIDED|95.0|-1.19|0.5|||t-test, 2 sided|||||0.50|-1.19|0.42
71070060|NCT01340027|141649007|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.85|TWO_SIDED|95.0|-0.3|0.3|||ANCOVA|||||0.3|-0.3|0.85
71070061|NCT01340027|141649007|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.024|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||-0.0|-0.6|0.024
71113375|NCT06899737|141734481|SUPERIORITY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.37||0.37|TWO_SIDED|95.0|-0.4|1.07|||t-test, 2 sided|||||1.07|-0.40|0.37
71113376|NCT06899737|141734483|SUPERIORITY||Mean Difference (Final Values)|6.72|STANDARD_ERROR_OF_MEAN|3.42||0.05|TWO_SIDED|95.0|-0.06|13.51|||t-test, 2 sided|||||13.51|-0.06|0.05
71113377|NCT06899737|141734484|SUPERIORITY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.35||0.23|TWO_SIDED|95.0|-0.26|1.11|||t-test, 2 sided|||||1.11|-0.26|0.23
71070062|NCT01340027|141649007|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.005|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|||||-0.1|-0.7|0.005
71070063|NCT01340027|141649007|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.003|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|||||-0.1|-0.7|0.003
71070064|NCT01340027|141649007|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.004|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|||||-0.2|-0.8|0.004
71113378|NCT06899737|141734485|SUPERIORITY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.37||0.08|TWO_SIDED|95.0|-0.09|1.39|||t-test, 2 sided|||||1.39|-0.09|0.08
71113379|NCT06899737|141734486|SUPERIORITY||Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.38||0.11|TWO_SIDED|95.0|-0.15|1.35|||t-test, 2 sided|||||1.35|-0.15|0.11
71113380|NCT06899737|141734487|SUPERIORITY||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|0.34||0.05|TWO_SIDED|95.0|-0.01|1.36|||t-test, 2 sided|||||1.36|-0.01|0.05
71113381|NCT01525862|141734578|SUPERIORITY||||||<|0.0001||||||P values \<0.05 are considered statistically significant.|t-test, 2 sided|||||||<0.0001
71113382|NCT01804049|141734593|SUPERIORITY|Hypothesis: metformin will reduce loss of total lean mass in insulin-resistant older adults over a three year period. It was determined (prior to the initiation of the study) that a sample size of 60 participants per group will have a 73% power to detect a 0.09 m/s difference in gait speed.||||||0.45||||||For lean total body mass, t(118)=0.744, p=0.45.|t-test, 2 sided|T-test calculation for total lean mass: 0.74.||||||0.45
71113383|NCT01804049|141734593|SUPERIORITY|Hypothesis: metformin will reduce loss of total appendicular lean mass in insulin-resistant older adults over a three year period. It was determined (prior to the initiation of the study) that a sample size of 60 participants per group will have a 73% power to detect a 0.09 m/s difference in gait speed.||||||0.79||||||For lean appendicular body mass, t(118) = 0.264, p=0.79.|t-test, 2 sided|T-test calculation appendicular lean mass: 0.26.||||||0.79
71113384|NCT01804049|141734594|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|t(118)=0.703, p=0.48||||||0.48
71113385|NCT01147250|141734596|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of lixisenatide versus placebo was to be claimed if the upper bound of the 2-sided 95% CI of the hazard ratio was \<1.3.|Hazard Ratio (HR)|1.017|||||TWO_SIDED|95.0|0.886|1.168|||||Lixisenatide vs Placebo|Analysis was performed using Cox proportional hazards model with treatment groups, and region (North America, South and Central America, Western Europe, Eastern Europe, Africa/Near East, and Asia/Pacific) as covariates, and the associated two-sided 95% confidence interval (CI).||1.168|0.886|
71113386|NCT01147250|141734596|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.017||||0.8542|TWO_SIDED|95.0|0.886|1.168|||Log Rank||Lixisenatide vs Placebo|Analysis was performed using Cox proportional hazards model with treatment groups, and region (North America, South and Central America, Western Europe, Eastern Europe, Africa/Near East, and Asia/Pacific) as covariates, and the associated two-sided 95% CI. Superiority of lixisenatide versus placebo was to be claimed if the upper bound of the 2-sided 95% CI of the hazard ratio was \<1.0.||1.168|0.886|0.8542
71113387|NCT03588806|141734600|SUPERIORITY|||||||0.218|||||||ANOVA|Univariate repeated measures ANOVA||||||0.218
71113388|NCT03588806|141734601|SUPERIORITY|||||||0.268|||||||ANOVA|Univariate repeated measures||||||0.268
71113389|NCT03588806|141734602|SUPERIORITY||||||<|0.001|||||||ANOVA|Univariate repeated measures ANOVA||||||<0.001
71113390|NCT03588806|141734603|SUPERIORITY|||||||0.228|||||||ANOVA|Univariate repeated measures ANOVA||||||0.228
71113391|NCT03588806|141734604|SUPERIORITY|||||||0.043|||||||ANOVA|Univariate repeated measures ANOVA||||||0.043
71113392|NCT03588806|141734605|SUPERIORITY|||||||0.486|||||||ANOVA|Univariate repeated measures ANOVA||PROMIS Social Roles score||||0.486
71113393|NCT03588806|141734605|SUPERIORITY|||||||0.078|||||||ANOVA|Univariate repeated measures ANOVA||PROMIS Sleep Disturbance T-Scores||||0.078
71113394|NCT03588806|141734605|SUPERIORITY|||||||0.874|||||||ANOVA|Univariate repeated measures ANOVA||PROMIS Depression T-Scores||||0.874
71113395|NCT03588806|141734605|SUPERIORITY|||||||0.389|||||||ANOVA|Univariate repeated measures ANOVA||PROMIS Anxiety T-Score||||0.389
71113396|NCT03588806|141734606|SUPERIORITY|||||||0.676|||||||ANOVA|Univariate repeated measures ANOVA||||||0.676
71113397|NCT03985943|141734609|OTHER||Strata-adjusted percentage difference|11.5||||0.0003|TWO_SIDED|97.5|4.7|18.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||18.3|4.7|0.0003
71070065|NCT01340027|141649007|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.15|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||||0.1|-0.6|0.15
71113398|NCT03985943|141734610|OTHER||Strata-adjusted percentage difference|14.3||||0.0002|TWO_SIDED|97.5|6.1|22.5||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||22.5|6.1|0.0002
71113399|NCT03985943|141734611|OTHER||Strata-adjusted percentage difference|14.9|||<|0.0001|TWO_SIDED|97.5|7.8|22.0||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||22.0|7.8|<0.0001
71113400|NCT03985943|141734612|OTHER||Strata-adjusted percentage difference|18.1|||<|0.0001|TWO_SIDED|97.5|9.6|26.6||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||26.6|9.6|<0.0001
71117692|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-5.26||||0.204|TWO_SIDED|95.0|-13.28|2.76||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.76|-13.28|0.204
70852818|NCT03456882|141194463|SUPERIORITY||Mean Difference (Net)|2.4|STANDARD_ERROR_OF_MEAN|2.6||0.3585|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.3585
70852819|NCT03456882|141194464|SUPERIORITY|||||||0.4388||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.4388
70852820|NCT03456882|141194464|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|20.2||0.9887|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.9887
70852821|NCT03456882|141194465|SUPERIORITY|||||||0.9622||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.9622
70852822|NCT03456882|141194465|SUPERIORITY||Mean Difference (Net)|6.5|STANDARD_ERROR_OF_MEAN|14.3||0.6533|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.6533
71070066|NCT01340027|141649007|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.99|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||||0.4|-0.4|0.99
71070067|NCT01340027|141649007|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.67|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||||0.3|-0.5|0.67
71070068|NCT01340027|141649007|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.44|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||||0.2|-0.5|0.44
71070069|NCT01340027|141649007|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.88|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||||0.4|-0.3|0.88
71070070|NCT01340027|141649007|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.53|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||||0.3|-0.5|0.53
71070071|NCT01340027|141649007|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.17||1|TWO_SIDED|95.0|-0.3|0.3|||ANCOVA|||||0.3|-0.3|1.0
71070072|NCT01340027|141649007|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.084|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||0.0|-0.6|0.084
71070073|NCT01340027|141649007|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.03|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|||||-0.0|-0.7|0.030
71070074|NCT01340027|141649007|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.02|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|||||-0.1|-0.7|0.020
71070075|NCT01340027|141649007|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.017|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|||||-0.1|-0.8|0.017
70938992|NCT00850993|141378568|OTHER|Pairwise comparison for each Stannsoporfin treatment group versus placebo.|LS Mean Difference|-13.45|||=|0.04|TWO_SIDED|95.0|-26.27|-0.62|||ANCOVA|||Last Observation Carry Forward (LOCF) is used to impute missing post-baseline TSB. Least-squares means are from an ANCOVA model for adjusted TSB with treatment and gestational age as fixed effects and baseline adjusted TSB as a covariate. TSB is calculated as \[(TSB - Phototherapy(PT) threshold)/ PT threshold \] X 100%.||-0.62|-26.27|=0.040
70938993|NCT00850993|141378568|OTHER||LS Mean Difference|-10.02|||=|0.117|TWO_SIDED|95.0|-22.61|2.58|||ANCOVA|||||2.58|-22.61|=0.117
70938994|NCT00850993|141378568|OTHER||LS Mean Difference|-14.93|||=|0.057|TWO_SIDED|95.0|-30.31|0.44|||ANCOVA|||||0.44|-30.31|=0.057
70938995|NCT00850993|141378569|OTHER|Pairwise comparison for Change from Baseline at 48 hours (Row 3) for Stannsoporfin treatment group versus placebo|LS Mean Difference|-1.81|||=|0.061|TWO_SIDED|95.0|-3.71|0.09|||ANCOVA|||Last Observation Carry Forward (LOCF) is used to impute missing post-baseline TSB. Analysis of covariance (ANCOVA) is conducted for TSB including treatment and gestational age as fixed effects and baseline TSB as a covariate. Least-squares means (LS means) and standard errors (SEM) are estimated for each treatment group and placebo. LS mean difference, 95% Confidence Interval, and p-value are estimated based on LS mean difference between each stannsoporfin group and placebo.||0.09|-3.71|=0.061
70938996|NCT00850993|141378569|OTHER|Pairwise comparison for Change from Baseline at 48 hours (Row 3) for Stannsoporfin treatment group versus placebo|LS Mean Difference|-1.34|||=|0.163|TWO_SIDED|95.0|-3.24|0.56|||ANCOVA|||Last Observation Carry Forward (LOCF) is used to impute missing post-baseline TSB. Analysis of covariance (ANCOVA) is conducted for TSB including treatment and gestational age as fixed effects and baseline TSB as a covariate. Least-squares means (LS means) and standard errors (SEM) are estimated for each treatment group and placebo. LS mean difference, 95% Confidence Interval, and p-value are estimated based on LS mean difference between each stannsoporfin group and placebo.||0.56|-3.24|=0.163
70938997|NCT00850993|141378569|OTHER|Pairwise comparison for Change from Baseline at 48 hours (Row 3) for Stannsoporfin treatment group versus placebo|LS Mean Difference|-2.63|||=|0.028|TWO_SIDED|95.0|-4.97|-0.3|||ANCOVA|||Last Observation Carry Forward (LOCF) is used to impute missing post-baseline TSB. Analysis of covariance (ANCOVA) is conducted for TSB including treatment and gestational age as fixed effects and baseline TSB as a covariate. Least-squares means (LS means) and standard errors (SEM) are estimated for each treatment group and placebo. LS mean difference, 95% Confidence Interval, and p-value are estimated based on LS mean difference between each stannsoporfin group and placebo.||-0.3|-4.97|=0.028
70938998|NCT02009865|141378644|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-14.2||||0.017|TWO_SIDED|95.0|-26.2|-2.8|||Wilcoxon (Mann-Whitney)||The estimated median difference and its 95% CI were based on Hodges Lehmann procedure|Missing values were imputed using probabilities of missing estimated from logistic regression||-2.8|-26.2|0.017
71070076|NCT01340027|141649007|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.26|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||||0.2|-0.6|0.26
70938999|NCT02009865|141378645|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-26.3||||0.0008|TWO_SIDED|95.0|-40.5|-11.5|||Wilcoxon (Mann-Whitney)||The estimated median difference and its 95% CI were based on Hodges Lehmann procedure.|Main analysis with missing values imputed using probabilities of missing estimated from logistic regression||-11.5|-40.5|0.0008
70939000|NCT02009865|141378646|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-9.0||||0.018|TWO_SIDED|95.0|-14.8|-2.8||Adjusted by using Hommel's procedure|Wilcoxon (Mann-Whitney)||The estimated median difference and its 95% CI were based on Hodges Lehmann procedure.|Missing values were imputed using probabilities of missing estimated from logistic regression||-2.8|-14.8|0.0180
70939001|NCT02009865|141378647|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.3||||0.7117|TWO_SIDED|95.0|-3.5|4.9||Adjusted by using Hommel's procedure|Wilcoxon (Mann-Whitney)||The estimated median difference and its 95% CI were based on Hodges Lehmann procedure.|Missing values were imputed using probabilities of missing estimated from logistic regression||4.9|-3.5|0.7117
70939002|NCT02009865|141378648|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-10.3||||0.3034|TWO_SIDED|95.0|-23.9|3.5||Adjusted by using Hommel's procedure|Wilcoxon (Mann-Whitney)||The estimated median difference and its 95% CI were based on Hodges Lehmann procedure.|Missing values were imputed using probabilities of missing estimated from logistic regression||3.5|-23.9|0.3034
70939003|NCT00760877|141378663|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.096||||0.1083|TWO_SIDED|95.0|0.766|5.738|||Cochran-Mantel-Haenszel|||||5.738|0.766|0.1083
70939004|NCT00946998|141378682|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||||||0.82
71070077|NCT01340027|141649008|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.26||||0.04|TWO_SIDED|95.0|1.04|4.95|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||4.95|1.04|0.040
71070078|NCT01340027|141649008|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.1||||0.73|TWO_SIDED|95.0|0.63|1.92|||Regression, Logistic|||||1.92|0.63|0.73
70939005|NCT00946998|141378683|SUPERIORITY|||||||0.28||||||Represents the response outcome.|Mixed Models Analysis|||||||0.28
71070079|NCT01340027|141649008|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.82||||0.05|TWO_SIDED|95.0|1.0|3.3|||Regression, Logistic|||||3.30|1.00|0.050
71070080|NCT01340027|141649008|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.45||||0.21|TWO_SIDED|95.0|0.81|2.59|||Regression, Logistic|||||2.59|0.81|0.21
71070081|NCT01340027|141649008|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.02||||0.021|TWO_SIDED|95.0|1.11|3.66|||Regression, Logistic|||||3.66|1.11|0.021
71070082|NCT01340027|141649008|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.64||||0.19|TWO_SIDED|95.0|0.79|3.4|||Regression, Logistic|||||3.40|0.79|0.19
71070083|NCT01340027|141649008|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.74|TWO_SIDED|95.0|0.57|2.19|||Regression, Logistic|||||2.19|0.57|0.74
71070084|NCT01340027|141649008|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.57|TWO_SIDED|95.0|0.58|2.71|||Regression, Logistic|||||2.71|0.58|0.57
71070085|NCT01340027|141649008|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.67||||0.19|TWO_SIDED|95.0|0.77|3.64|||Regression, Logistic|||||3.64|0.77|0.19
71070086|NCT01340027|141649008|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.86||||0.69|TWO_SIDED|95.0|0.41|1.79|||Regression, Logistic|||||1.79|0.41|0.69
71070087|NCT01340027|141649008|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||0.9|TWO_SIDED|95.0|0.55|1.99|||Regression, Logistic|||||1.99|0.55|0.90
71070088|NCT01340027|141649008|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.36||||0.048|TWO_SIDED|95.0|1.01|5.55|||Regression, Logistic|||||5.55|1.01|0.048
71113401|NCT03985943|141734613|OTHER||Strata-adjusted percentage difference|24.9|||<|0.0001|TWO_SIDED|97.5|18.4|31.5||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level. Participants with missing data were considered non-responders.||31.5|18.4|<0.0001
71113402|NCT03985943|141734613|OTHER||Strata-adjusted percentage difference|28.1|||<|0.0001|TWO_SIDED|97.5|22.0|34.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel||The estimates are from 50 complete datasets by MI-MAR assumption.|Nemolizumab 30 mg versus Placebo using multiple imputation (MI) with missing at random (MAR) assumption.||34.3|22.0|<0.0001
71113403|NCT03985943|141734614|OTHER||Strata-adjusted percentage difference|27.5|||<|0.0001|TWO_SIDED|97.5|19.4|35.7||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\].|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level. Participants with missing data were considered non-responders.||35.7|19.4|<0.0001
71113404|NCT03985943|141734614|OTHER||Strata-adjusted percentage difference|32.1|||<|0.0001|TWO_SIDED|97.5|24.4|39.8||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\].|Cochran-Mantel-Haenszel||The estimates are from 50 complete datasets by MI-MAR assumption.|Nemolizumab 30 mg versus Placebo using MI-MAR assumption.||39.8|24.4|<0.0001
71113405|NCT03985943|141734615|OTHER||Strata-adjusted percentage difference|19.5|||<|0.0001|TWO_SIDED|97.5|13.7|25.2||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||25.2|13.7|<0.0001
71113406|NCT03985943|141734616|OTHER||Strata-adjusted percentage difference|20.3|||<|0.0001|TWO_SIDED|97.5|13.8|26.8||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||26.8|13.8|<0.0001
71113407|NCT03985943|141734617|OTHER||Strata-adjusted percentage difference|17.9|||<|0.0001|TWO_SIDED|97.5|11.3|24.5||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||24.5|11.3|<0.0001
71113408|NCT03985943|141734618|OTHER||Strata-adjusted percentage difference|19.7|||<|0.0001|TWO_SIDED|97.5|11.2|28.2||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||28.2|11.2|<0.0001
71113409|NCT03985943|141734619|OTHER||Strata-adjusted percentage difference|20.9|||<|0.0001|TWO_SIDED|97.5|15.8|26.0||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||26|15.8|<0.0001
70939006|NCT00946998|141378683|SUPERIORITY|||||||0.86||||||Represents remission outcome.|Mixed Models Analysis|||||||0.86
70939007|NCT00946998|141378684|SUPERIORITY|||||||0.32|||||||Mixed Models Analysis|||||||0.32
70939008|NCT00946998|141378685|SUPERIORITY|||||||0.61|||||||Mixed Models Analysis|||||||0.61
70939009|NCT00946998|141378686|SUPERIORITY||||||>|0.99||||||For death|Chi-squared|||||||>.99
71070089|NCT01340027|141649008|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.15||||0.67|TWO_SIDED|95.0|0.6|2.22|||Regression, Logistic|||||2.22|0.60|0.67
71070090|NCT01340027|141649008|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.07|TWO_SIDED|95.0|0.95|3.78|||Regression, Logistic|||||3.78|0.95|0.070
71070091|NCT01340027|141649008|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.51||||0.23|TWO_SIDED|95.0|0.77|2.98|||Regression, Logistic|||||2.98|0.77|0.23
71070092|NCT01340027|141649008|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.11||||0.034|TWO_SIDED|95.0|1.06|4.19|||Regression, Logistic|||||4.19|1.06|0.034
71070093|NCT01340027|141649008|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.71||||0.2|TWO_SIDED|95.0|0.76|3.84|||Regression, Logistic|||||3.84|0.76|0.20
71070094|NCT01340027|141649008|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17||||0.68|TWO_SIDED|95.0|0.55|2.49|||Regression, Logistic|||||2.49|0.55|0.68
71070095|NCT01340027|141649009|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.62|TWO_SIDED|95.0|0.64|2.12|||Regression, Logistic|||||2.12|0.64|0.62
71070096|NCT01340027|141649009|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.33||||0.25|TWO_SIDED|95.0|0.82|2.17|||Regression, Logistic|||||2.17|0.82|0.25
70939010|NCT00946998|141378686|SUPERIORITY|||||||0.77||||||For comparison of dialysis initiation between groups.|Chi-squared|||||||0.77
70939011|NCT00946998|141378686|SUPERIORITY||||||>|0.99||||||Hospitalization other than dialysis initiation|Chi-squared|||||||>0.99
71070097|NCT01340027|141649009|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.48||||0.11|TWO_SIDED|95.0|0.91|2.41|||Regression, Logistic|||||2.41|0.91|0.11
71070098|NCT01340027|141649009|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.81||||0.02|TWO_SIDED|95.0|1.1|2.97|||Regression, Logistic|||||2.97|1.10|0.020
71070099|NCT01340027|141649009|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.87||||0.012|TWO_SIDED|95.0|1.15|3.05|||Regression, Logistic|||||3.05|1.15|0.012
71070100|NCT01340027|141649009|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.72||||0.072|TWO_SIDED|95.0|0.95|3.1|||Regression, Logistic|||||3.10|0.95|0.072
71070101|NCT01340027|141649009|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.29|TWO_SIDED|95.0|0.77|2.44|||Regression, Logistic|||||2.44|0.77|0.29
71070102|NCT01340027|141649009|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.98||||0.94|TWO_SIDED|95.0|0.49|1.93|||Regression, Logistic|||||1.93|0.49|0.94
71070103|NCT01340027|141649009|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.91||||0.8|TWO_SIDED|95.0|0.46|1.81|||Regression, Logistic|||||1.81|0.46|0.80
71070104|NCT01340027|141649009|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.67|TWO_SIDED|95.0|0.59|2.28|||Regression, Logistic|||||2.28|0.59|0.67
71070105|NCT01340027|141649009|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.55|1.8|||Regression, Logistic|||||1.80|0.55|1.0
71070106|NCT01340027|141649009|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.66|TWO_SIDED|95.0|0.59|2.31|||Regression, Logistic|||||2.31|0.59|0.66
71070107|NCT01340027|141649009|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.33||||0.35|TWO_SIDED|95.0|0.73|2.4|||Regression, Logistic|||||2.40|0.73|0.35
71070108|NCT01340027|141649009|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.48||||0.19|TWO_SIDED|95.0|0.82|2.67|||Regression, Logistic|||||2.67|0.82|0.19
71070109|NCT01340027|141649009|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.8||||0.054|TWO_SIDED|95.0|0.99|3.28|||Regression, Logistic|||||3.28|0.99|0.054
71070110|NCT01340027|141649009|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.87||||0.038|TWO_SIDED|95.0|1.04|3.38|||Regression, Logistic|||||3.38|1.04|0.038
71070111|NCT01340027|141649009|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.72||||0.12|TWO_SIDED|95.0|0.87|3.39|||Regression, Logistic|||||3.39|0.87|0.12
71070112|NCT01340027|141649009|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.36|TWO_SIDED|95.0|0.7|2.67|||Regression, Logistic|||||2.67|0.70|0.36
71070113|NCT01340027|141649010|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.4||||0.32|TWO_SIDED|95.0|0.06|2.43|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||2.43|0.06|0.32
71070114|NCT01340027|141649010|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.75||||0.65|TWO_SIDED|95.0|0.21|2.61|||Regression, Logistic|||||2.61|0.21|0.65
71070115|NCT01340027|141649010|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.54||||0.39|TWO_SIDED|95.0|0.13|2.19|||Regression, Logistic|||||2.19|0.13|0.39
71070116|NCT01340027|141649010|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.41||||0.22|TWO_SIDED|95.0|0.1|1.67|||Regression, Logistic|||||1.67|0.10|0.22
71070117|NCT01340027|141649010|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.22||||0.082|TWO_SIDED|95.0|0.04|1.22|||Regression, Logistic|||||1.22|0.04|0.082
71070118|NCT01340027|141649010|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.36||||0.36|TWO_SIDED|95.0|0.04|3.2|||Regression, Logistic|||||3.20|0.04|0.36
71070119|NCT01340027|141649010|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.51|TWO_SIDED|95.0|0.42|5.71|||Regression, Logistic|||||5.71|0.42|0.51
71070120|NCT01340027|141649010|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01||||0.99|TWO_SIDED|95.0|0.19|5.36|||Regression, Logistic|||||5.36|0.19|0.99
71070121|NCT01340027|141649010|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||0.96|TWO_SIDED|95.0|0.24|4.59|||Regression, Logistic|||||4.59|0.24|0.96
71070122|NCT01340027|141649010|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.62||||0.57|TWO_SIDED|95.0|0.12|3.3|||Regression, Logistic|||||3.30|0.12|0.57
71070123|NCT01340027|141649010|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.06||||0.93|TWO_SIDED|95.0|0.28|3.95|||Regression, Logistic|||||3.95|0.28|0.93
71070124|NCT01340027|141649010|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.42||||0.37|TWO_SIDED|95.0|0.06|2.79|||Regression, Logistic|||||2.79|0.06|0.37
71070125|NCT01340027|141649010|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.79||||0.74|TWO_SIDED|95.0|0.2|3.13|||Regression, Logistic|||||3.13|0.20|0.74
71070126|NCT01340027|141649010|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.57||||0.46|TWO_SIDED|95.0|0.12|2.59|||Regression, Logistic|||||2.59|0.12|0.46
71070127|NCT01340027|141649010|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.44||||0.28|TWO_SIDED|95.0|0.1|1.96|||Regression, Logistic|||||1.96|0.10|0.28
71070128|NCT01340027|141649010|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.23||||0.11|TWO_SIDED|95.0|0.04|1.4|||Regression, Logistic|||||1.40|0.04|0.11
71070129|NCT01340027|141649010|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.38||||0.4|TWO_SIDED|95.0|0.04|3.66|||Regression, Logistic|||||3.66|0.04|0.40
71070130|NCT01340027|141649010|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.64||||0.5|TWO_SIDED|95.0|0.39|6.85|||Regression, Logistic|||||6.85|0.39|0.50
71070131|NCT01340027|141649011|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|2.47||0.21|TWO_SIDED|95.0|-8.0|1.7|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||1.7|-8.0|0.21
71070132|NCT01340027|141649011|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|2.03||0.54|TWO_SIDED|95.0|-5.2|2.7|||ANCOVA|||||2.7|-5.2|0.54
70939012|NCT00946998|141378686|SUPERIORITY|||||||0.5||||||For comparison of acute suicidal intent.|Chi-squared|||||||0.5
71070133|NCT01340027|141649011|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|2.03||0.016|TWO_SIDED|95.0|-8.9|-0.9|||ANCOVA|||||-0.9|-8.9|0.016
71070134|NCT01340027|141649011|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|2.05||0.011|TWO_SIDED|95.0|-9.3|-1.2|||ANCOVA|||||-1.2|-9.3|0.011
71113410|NCT03985943|141734620|OTHER||Strata-adjusted percentage difference|21.2|||<|0.0001|TWO_SIDED|97.5|14.8|27.6||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||27.6|14.8|<0.0001
71113411|NCT03985943|141734621|OTHER||Strata-adjusted percentage difference|12.2|||<|0.0001|TWO_SIDED|97.5|8.2|16.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||16.3|8.2|<0.0001
71113412|NCT03985943|141734622|OTHER||Strata-adjusted percentage difference|9.7|||<|0.0001|TWO_SIDED|97.5|5.2|14.2||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||14.2|5.2|<0.0001
71113413|NCT03985943|141734623|OTHER||Strata-adjusted percentage difference|14.6|||<|0.0001|TWO_SIDED|97.5|10.6|18.7||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||18.7|10.6|<0.0001
71113414|NCT03985943|141734624|OTHER||Strata-adjusted percentage difference|16.9|||<|0.0001|TWO_SIDED|97.5|11.5|22.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||22.3|11.5|<0.0001
71113415|NCT03985943|141734625|OTHER||Strata-adjusted percentage difference|3.4||||0.0064|TWO_SIDED|97.5|1.1|5.8||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||5.8|1.1|0.0064
71113416|NCT03985943|141734626|OTHER||Strata-adjusted percentage difference|4.3||||0.0177|TWO_SIDED|97.5|0.9|7.7||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for preceding outcome measure was statistically significant at two-sided 2.5% significance level.||7.7|0.9|0.0177
71113417|NCT00716482|141734650|SUPERIORITY_OR_OTHER||Specificity of lesion shape|0.694|||<|0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||Null hypothesis is that there is no difference between the two tests.||||<0.001
70939013|NCT00946998|141378686|SUPERIORITY||||||>|0.99||||||For comparison of bleeding requiring blood transfusion or hospitalization.|Chi-squared|||||||>0.99
70939014|NCT04694300|141378738|SUPERIORITY|Lower the maximum pain intensity score the more effective the analgesic|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70939015|NCT04694300|141378739|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70852823|NCT03456882|141194466|SUPERIORITY|||||||0.9137||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.9137
70939016|NCT04694300|141378740|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
70939017|NCT04694300|141378741|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70939018|NCT04694300|141378744|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
70939019|NCT04694300|141378745|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71070135|NCT01340027|141649011|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-10.7|-2.8|||ANCOVA|||||-2.8|-10.7|<0.001
71070136|NCT01340027|141649011|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|2.43||0.005|TWO_SIDED|95.0|-11.6|-2.0|||ANCOVA|||||-2.0|-11.6|0.005
71070137|NCT01340027|141649011|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.7|STANDARD_ERROR_OF_MEAN|2.44||0.056|TWO_SIDED|95.0|-9.4|0.1|||ANCOVA|||||0.1|-9.4|0.056
71113418|NCT00716482|141734650|SUPERIORITY_OR_OTHER||Lesion homogeneity spec, conservative|0.714|||<|0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image specificity of the homogeneity of elasticity with the lesion and surrounding tissue using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if they were not homogeneous on the color overlay SW elastographic image; BIRADS 4a mass downgraded to BIRADS 3' if they were very homogeneous).~Null hypothesis is that there is no difference between the two tests."||||<0.001
71113419|NCT00716482|141734650|SUPERIORITY_OR_OTHER||Lesion homogeneity spec, agressive|0.785|||<|0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image specificity of the homogeneity of elasticity with the lesion and surrounding tissue using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if they were not homogeneous on the color overlay SW elastographic image; BIRADS 4a mass downgraded to BIRADS 3' if they were very or reasonably homogeneous).~Null hypothesis is that there is no difference between the two tests."||||<0.001
71113420|NCT00716482|141734650|SUPERIORITY_OR_OTHER||Max. elasticity specificity,conservative|0.657||||0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image specificity of the maximum elasticity using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if maximum elasticity was 160 kiloPascals (kPa) (7.3 m/sec) or more; BIRADS 4a mass downgraded to BIRADS 3' if the maximum elasticity was 30 kPa (3.2 m/sec) or less).~Null hypothesis is that there is no difference between the two tests."||||0.001
70939020|NCT04694300|141378746|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|Higher percentage inhibition relates to greater selectivity for COX-2||||||0.59
71070138|NCT01340027|141649011|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|2.81||0.56|TWO_SIDED|95.0|-7.1|3.9|||ANCOVA|||||3.9|-7.1|0.56
71070139|NCT01340027|141649011|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.8||0.48|TWO_SIDED|95.0|-7.5|3.5|||ANCOVA|||||3.5|-7.5|0.48
71070140|NCT01340027|141649011|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|0.13||0.13|TWO_SIDED|95.0|-9.8|1.2|||ANCOVA|||||1.2|-9.8|0.13
71070141|NCT01340027|141649011|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|2.42||0.61|TWO_SIDED|95.0|-6.0|3.5|||ANCOVA|||||3.5|-6.0|0.61
71070142|NCT01340027|141649011|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|2.81||0.12|TWO_SIDED|95.0|-9.9|1.2|||ANCOVA|||||1.2|-9.9|0.12
71070143|NCT01340027|141649011|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|2.44||0.31|TWO_SIDED|95.0|-7.3|2.3|||ANCOVA|||||2.3|-7.3|0.31
71070144|NCT01340027|141649011|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|2.44||0.012|TWO_SIDED|95.0|-10.9|-1.3|||ANCOVA|||||-1.3|-10.9|0.012
71070145|NCT01340027|141649011|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|2.46||0.008|TWO_SIDED|95.0|-11.3|-1.7|||ANCOVA|||||-1.7|-11.3|0.008
71070146|NCT01340027|141649011|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|2.44||0.001|TWO_SIDED|95.0|-12.8|-3.2|||ANCOVA|||||-3.2|-12.8|0.001
71070147|NCT01340027|141649011|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|2.78||0.004|TWO_SIDED|95.0|-13.5|-2.6|||ANCOVA|||||-2.6|-13.5|0.004
71070148|NCT01340027|141649011|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|2.79||0.035|TWO_SIDED|95.0|-11.4|-0.4|||ANCOVA|||||-0.4|-11.4|0.035
71070149|NCT01340027|141649012|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.42||||0.4|TWO_SIDED|95.0|0.63|3.2|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||3.20|0.63|0.40
71070150|NCT01340027|141649012|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||0.89|TWO_SIDED|95.0|0.55|1.97|||Regression, Logistic|||||1.97|0.55|0.89
71070151|NCT01340027|141649012|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.21||||0.57|TWO_SIDED|95.0|0.63|2.33|||Regression, Logistic|||||2.33|0.63|0.57
71070152|NCT01340027|141649012|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.36||||0.36|TWO_SIDED|95.0|0.7|2.66|||Regression, Logistic|||||2.66|0.70|0.36
70939021|NCT04694300|141378747|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
71070153|NCT01340027|141649012|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.66||||0.15|TWO_SIDED|95.0|0.83|3.32|||Regression, Logistic|||||3.32|0.83|0.15
71070154|NCT01340027|141649012|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.31|TWO_SIDED|95.0|0.67|3.59|||Regression, Logistic|||||3.59|0.67|0.31
71070155|NCT01340027|141649012|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.91||||0.81|TWO_SIDED|95.0|0.42|1.95|||Regression, Logistic|||||1.95|0.42|0.81
71070156|NCT01340027|141649012|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.75||||0.19|TWO_SIDED|95.0|0.75|4.08|||Regression, Logistic|||||4.08|0.75|0.19
71070157|NCT01340027|141649012|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.59|TWO_SIDED|95.0|0.56|2.77|||Regression, Logistic|||||2.77|0.56|0.59
70852824|NCT03456882|141194466|SUPERIORITY||Mean Difference (Net)|16.7|STANDARD_ERROR_OF_MEAN|19.7||0.3985|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.3985
71113421|NCT00716482|141734650|SUPERIORITY_OR_OTHER||Max. elasticity specificity, aggressive|0.774|||<|0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image specificity of the maximum elasticity using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if maximum elasticity was 160 kPa(7.3 m/sec) or more; BIRADS 4a mass downgraded to BIRADS 3' if the maximum elasticity was 80 kPa (5.2 m/sec) or less).~Null hypothesis is that there is no difference between the two tests."||||<0.001
71070158|NCT01340027|141649012|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.97||||0.13|TWO_SIDED|95.0|0.83|4.71|||Regression, Logistic|||||4.71|0.83|0.13
71070159|NCT01340027|141649012|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.57||||0.2|TWO_SIDED|95.0|0.78|3.16|||Regression, Logistic|||||3.16|0.78|0.20
71070160|NCT01340027|141649012|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.24||||0.07|TWO_SIDED|95.0|0.94|5.34|||Regression, Logistic|||||5.34|0.94|0.070
71070161|NCT01340027|141649012|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.64||||0.17|TWO_SIDED|95.0|0.81|3.33|||Regression, Logistic|||||3.33|0.81|0.17
71113422|NCT00716482|141734650|SUPERIORITY_OR_OTHER||median mean elasticity value specificity|0.626||||0.18|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image median mean elasticity value.~Null hypothesis is that there is no difference between the two tests."||||0.18
70852825|NCT03456882|141194467|SUPERIORITY|||||||0.2543||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.2543
70852826|NCT03456882|141194467|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.22||0.2209|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.2209
70852827|NCT03456882|141194468|SUPERIORITY|||||||0.2738||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.2738
71070162|NCT01340027|141649012|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.084|TWO_SIDED|95.0|0.92|3.92|||Regression, Logistic|||||3.92|0.92|0.084
71070163|NCT01340027|141649012|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.14||||0.043|TWO_SIDED|95.0|1.02|4.48|||Regression, Logistic|||||4.48|1.02|0.043
71070164|NCT01340027|141649012|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.61||||0.013|TWO_SIDED|95.0|1.22|5.58|||Regression, Logistic|||||5.58|1.22|0.013
71070165|NCT01340027|141649012|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.43||||0.053|TWO_SIDED|95.0|0.99|5.97|||Regression, Logistic|||||5.97|0.99|0.053
71070166|NCT01340027|141649012|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.43||||0.39|TWO_SIDED|95.0|0.63|3.26|||Regression, Logistic|||||3.26|0.63|0.39
71070167|NCT01340027|141649013|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|2.55||0.26|TWO_SIDED|95.0|-2.1|7.9|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||7.9|-2.1|0.26
71070168|NCT01340027|141649013|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|2.1||0.38|TWO_SIDED|95.0|-2.3|6.0|||ANCOVA|||||6.0|-2.3|0.38
71070169|NCT01340027|141649013|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differrence|4.8|STANDARD_ERROR_OF_MEAN|2.1||0.022|TWO_SIDED|95.0|0.7|8.9|||ANCOVA|||||8.9|0.7|0.022
71070170|NCT01340027|141649013|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|2.12||0.01|TWO_SIDED|95.0|1.3|9.7|||ANCOVA|||||9.7|1.3|0.010
71070171|NCT01340027|141649013|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.4|STANDARD_ERROR_OF_MEAN|2.09||0.002|TWO_SIDED|95.0|2.3|10.5|||ANCOVA|||||10.5|2.3|0.002
71070172|NCT01340027|141649013|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|2.52||0.008|TWO_SIDED|95.0|1.7|11.6|||ANCOVA|||||11.6|1.7|0.008
71070173|NCT01340027|141649013|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|2.52||0.037|TWO_SIDED|95.0|0.3|10.2|||ANCOVA|||||10.2|0.3|0.037
71070174|NCT01340027|141649013|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.9||0.5|TWO_SIDED|95.0|-7.7|3.7|||ANCOVA|||||3.7|-7.7|0.50
71070175|NCT01340027|141649013|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|2.89||0.65|TWO_SIDED|95.0|-4.4|7.0|||ANCOVA|||||7.0|-4.4|0.65
71070176|NCT01340027|141649013|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|2.88||0.25|TWO_SIDED|95.0|-2.4|8.9|||ANCOVA|||||8.9|-2.4|0.25
71070177|NCT01340027|141649013|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|2.51||0.76|TWO_SIDED|95.0|-5.7|4.1|||ANCOVA|||||4.1|-5.7|0.76
71113423|NCT00716482|141734650|SUPERIORITY_OR_OTHER||Diameter ratio specificity|0.512||||0.006|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image diameter ratio.~Null hypothesis is that there is no difference between the two tests."||||0.006
71113424|NCT00716482|141734650|SUPERIORITY_OR_OTHER||Median elasticity ratio specificity|0.649||||0.006|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image median elasticity ratio.~Null hypothesis is that there is no difference between the two tests."||||0.006
71113425|NCT00716482|141734650|SUPERIORITY_OR_OTHER||Max.color scale specificity,conservative|0.703|||<|0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image specificity of color using a six-point color scale of maximum elasticity in the mass and surrounding parenchyma using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if the max stiffness on the color overlay SW elastographic image was red; BIRADS 4a mass downgraded to BIRADS 3' if the max stiffness on the color overlay SW elastographic image was black to dark blue).~Null hypothesis is that there is no difference between the two tests."||||<0.001
71113426|NCT00716482|141734650|SUPERIORITY_OR_OTHER||Max. color scale specificity, aggressive|0.785|||<|0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05~Overall specificity = 78.5%"|McNemar|||"Elastography image specificity of color using a six-point color scale of maximum elasticity in the mass and surrounding parenchyma using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if the max stiffness on the color overlay SW elastographic image was red; BIRADS 4a mass downgraded to BIRADS 3' if the max stiffness on the color overlay SW elastographic image was black to dark blue, or light blue).~Null hypothesis is that there is no difference between the two tests."||||<0.001
71113427|NCT00716482|141734650|SUPERIORITY_OR_OTHER||Lesion shape sensitivity|0.979||||0.48|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image lesion shape.~Null hypothesis is that there is no difference between the two tests."||||0.48
71113428|NCT00716482|141734650|SUPERIORITY_OR_OTHER||Lesion homogeneity sens, conservative|0.969||||0.74|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image sensitivity of the homogeneity of elasticity with the lesion and surrounding tissue using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if they were not homogeneous on the color overlay SW elastographic image; BIRADS 4a mass downgraded to BIRADS 3' if they were very homogeneous).~Null hypothesis is that there is no difference between the two tests."||||0.74
71113429|NCT00716482|141734650|SUPERIORITY_OR_OTHER||elasticity homogeneity,aggressive,sensit|0.962||||0.37|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image sensitivity of the homogeneity of elasticity with the lesion and surrounding tissue using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if they were not homogeneous on the color overlay SW elastographic image; BIRADS 4a mass downgraded to BIRADS 3' if they were very or reasonably homogeneous).~Null hypothesis is that there is no difference between the two tests."||||0.37
71113430|NCT00716482|141734650|SUPERIORITY_OR_OTHER||elasticity homegeneity,conservative,sens|0.99||||0.025|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05~Overall sensitivity = 99.0%"|McNemar|||"Elastography image sensitivity of the maximum elasticity using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if maximum elasticity was 160 kPa(7.3 m/sec) or more; BIRADS 4a mass downgraded to BIRADS 3' if the maximum elasticity was 30 kPa (3.2 m/sec) or less).~Null hypothesis is that there is no difference between the two tests."||||0.025
71113431|NCT00716482|141734650|SUPERIORITY_OR_OTHER||max. elasticity sensitivity,aggressive|0.972|||>|0.99|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image sensitivity of the maximum elasticity using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if maximum elasticity was 160 kPa(7.3 m/sec) or more; BIRADS 4a mass downgraded to BIRADS 3' if the maximum elasticity was 80 kPa (5.2 m/sec) or less).~Null hypothesis is that there is no difference between the two tests."||||>0.99
71113432|NCT00716482|141734650|SUPERIORITY_OR_OTHER||median mean elasticity value sensitivity|0.986||||0.046|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image median mean elasticity value.~Null hypothesis is that there is no difference between the two tests."||||0.046
71113433|NCT00716482|141734650|SUPERIORITY_OR_OTHER||diameter ratio sensitivity|0.99||||0.025|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image diameter ratio.~Null hypothesis is that there is no difference between the two tests."||||0.025
70939022|NCT01322347|141378750|SUPERIORITY_OR_OTHER||Difference in LS Means between SFP & PBO|3.6|STANDARD_ERROR_OF_MEAN|1.39||0.011|TWO_SIDED|95.0||||LS Mean (SE) and p-value are from ANCOVA model with baseline Hgb as covariate. Model also includes indicator variable for baseline ESA dose stratum.|ANCOVA|||||||0.011
71113434|NCT00716482|141734650|SUPERIORITY_OR_OTHER||median elasticity ratio sensitivity|0.983||||0.083|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image median elasticity ratio.~Null hypothesis is that there is no difference between the two tests."||||0.083
70852828|NCT03456882|141194468|SUPERIORITY||Mean Difference (Net)|-2.9|STANDARD_ERROR_OF_MEAN|3.7||0.4239|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.4239
70852829|NCT03456882|141194469|SUPERIORITY|||||||0.1708||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.1708
70852830|NCT03456882|141194469|SUPERIORITY||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.25||0.8133|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.8133
71029102|NCT01062256|141565698|SUPERIORITY_OR_OTHER||weighted Goodman-Kruskal Gamma statistic|-0.12||||0.256|TWO_SIDED|95.0|-0.32|0.08||p-values from Cochran-Mantel-Haenszel test with modified ridit scores, controlling for gender, time stratum, and site.|Cochran-Mantel-Haenszel|||Pairwise comparison of global evaluation of study medication.||0.08|-0.32|0.256
71070178|NCT01340027|141649013|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|2.91||0.47|TWO_SIDED|95.0|-3.6|7.8|||ANCOVA|||||7.8|-3.6|0.47
71070179|NCT01340027|141649013|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|2.52||0.67|TWO_SIDED|95.0|-3.9|6.0|||ANCOVA|||||6.0|-3.9|0.67
71070180|NCT01340027|141649013|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|2.52||0.11|TWO_SIDED|95.0|-0.9|9.0|||ANCOVA|||||9.0|-0.9|0.11
71070181|NCT01340027|141649013|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|2.54||0.062|TWO_SIDED|95.0|-0.2|9.7|||ANCOVA|||||9.7|-0.2|0.062
71070182|NCT01340027|141649013|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.6|STANDARD_ERROR_OF_MEAN|2.52||0.025|TWO_SIDED|95.0|0.7|10.6|||ANCOVA|||||10.6|0.7|0.025
71070183|NCT01340027|141649013|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|2.88||0.041|TWO_SIDED|95.0|0.2|11.5|||ANCOVA|||||11.5|0.2|0.041
71070184|NCT01340027|141649013|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.5|STANDARD_ERROR_OF_MEAN|2.88||0.12|TWO_SIDED|95.0|-1.2|10.1|||ANCOVA|||||10.1|-1.2|0.12
71070185|NCT01340027|141649014|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||0.92|TWO_SIDED|95.0|0.52|2.08|||Regression, Logistic|||"All statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||2.08|0.52|0.92
71070186|NCT01340027|141649014|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01||||0.98|TWO_SIDED|95.0|0.58|1.77|||Regression, Logistic|||||1.77|0.58|0.98
71070187|NCT01340027|141649014|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.45|TWO_SIDED|95.0|0.7|2.23|||Regression, Logistic|||||2.23|0.70|0.45
71070188|NCT01340027|141649014|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.41||||0.24|TWO_SIDED|95.0|0.79|2.53|||Regression, Logistic|||||2.53|0.79|0.24
71070189|NCT01340027|141649014|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.21||||0.012|TWO_SIDED|95.0|1.19|4.09|||Regression, Logistic|||||4.09|1.19|0.012
71070190|NCT01340027|141649014|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.43||||0.32|TWO_SIDED|95.0|0.7|2.9|||Regression, Logistic|||||2.90|0.70|0.32
71070191|NCT01340027|141649014|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.51||||0.27|TWO_SIDED|95.0|0.72|3.14|||Regression, Logistic|||||3.14|0.72|0.27
71070192|NCT01340027|141649014|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.5||||0.064|TWO_SIDED|95.0|0.24|1.04|||Regression, Logistic|||||1.04|0.24|0.064
71070193|NCT01340027|141649014|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.24||||0.57|TWO_SIDED|95.0|0.59|2.61|||Regression, Logistic|||||2.61|0.59|0.57
71070194|NCT01340027|141649014|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.26||||0.55|TWO_SIDED|95.0|0.59|2.68|||Regression, Logistic|||||2.68|0.59|0.55
71070195|NCT01340027|141649014|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.11||||0.75|TWO_SIDED|95.0|0.58|2.13|||Regression, Logistic|||||2.13|0.58|0.75
71070196|NCT01340027|141649014|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.15||||0.72|TWO_SIDED|95.0|0.53|2.49|||Regression, Logistic|||||2.49|0.53|0.72
71070197|NCT01340027|141649014|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.74|TWO_SIDED|95.0|0.58|2.15|||Regression, Logistic|||||2.15|0.58|0.74
71070198|NCT01340027|141649014|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.39||||0.34|TWO_SIDED|95.0|0.71|2.71|||Regression, Logistic|||||2.71|0.71|0.34
71070199|NCT01340027|141649014|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.57||||0.19|TWO_SIDED|95.0|0.8|3.07|||Regression, Logistic|||||3.07|0.80|0.19
71070200|NCT01340027|141649014|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.45||||0.012|TWO_SIDED|95.0|1.22|4.94|||Regression, Logistic|||||4.94|1.22|0.012
71070201|NCT01340027|141649014|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.59||||0.25|TWO_SIDED|95.0|0.72|3.47|||Regression, Logistic|||||3.47|0.72|0.25
71070202|NCT01340027|141649014|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.67||||0.21|TWO_SIDED|95.0|0.74|3.75|||Regression, Logistic|||||3.75|0.74|0.21
71070203|NCT01340027|141649022|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.376||0.63|TWO_SIDED|95.0|-0.56|0.92|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||0.92|-0.56|0.63
71070204|NCT01340027|141649022|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.31||0.56|TWO_SIDED|95.0|-0.43|0.79|||ANCOVA|||||0.79|-0.43|0.56
71070205|NCT01340027|141649022|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.308||0.14|TWO_SIDED|95.0|-0.15|1.06|||ANCOVA|||||1.06|-0.15|0.14
71113435|NCT00716482|141734650|SUPERIORITY_OR_OTHER||Max.color scale sensitivity,conservative|0.997||||0.008|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image sensitivity of color using a six-point color scale of maximum elasticity in the mass and surrounding parenchyma using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if the max stiffness on the color overlay SW elastographic image was red; BIRADS 4a mass downgraded to BIRADS 3' if the max stiffness on the color overlay SW elastographic image was black to dark blue).~Null hypothesis is that there is no difference between the two tests."||||0.008
71113436|NCT00716482|141734650|SUPERIORITY_OR_OTHER||Max. color scale sensitivity, aggressive|0.986||||0.21|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image sensitivity of color using a six-point color scale of maximum elasticity in the mass and surrounding parenchyma using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if the max stiffness on the color overlay SW elastographic image was red; BIRADS 4a mass downgraded to BIRADS 3' if the max stiffness on the color overlay SW elastographic image was black to dark blue, or light blue).~Null hypothesis is that there is no difference between the two tests."||||0.21
71113437|NCT00716482|141734651|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|Kruskal-Wallis one-way ANOVA. Kruskal-Wallis was performed once to get p-values for all of the 9 categories at once.||Null hypothesis: no variance of similarity exists between the three groups||||<0.001
71113438|NCT01092780|141734654|SUPERIORITY_OR_OTHER||Difference in LS means|8.16|||||TWO_SIDED|95.0|6.11|10.2||||||Difference in least squares (LS) means||10.20|6.11|
71113439|NCT01092780|141734654|SUPERIORITY_OR_OTHER||Difference in LS means|8.11|||||TWO_SIDED|95.0|6.07|10.15||||||Difference in LS means||10.15|6.07|
71113440|NCT01092780|141734655|SUPERIORITY_OR_OTHER||Difference in LS means|-0.07|||||TWO_SIDED|95.0|-0.1|-0.05||||||Difference in LS means||-0.05|-0.10|
71113441|NCT01092780|141734655|SUPERIORITY_OR_OTHER||Difference in LS means|-0.07|||||TWO_SIDED|95.0|-0.09|-0.05||||||Difference in LS means||-0.05|-0.09|
71070206|NCT01340027|141649022|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.313||0.027|TWO_SIDED|95.0|0.08|1.3|||ANCOVA|||||1.30|0.08|0.027
71070207|NCT01340027|141649022|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.308||0.13|TWO_SIDED|95.0|-0.14|1.07|||ANCOVA|||||1.07|-0.14|0.13
71070208|NCT01340027|141649022|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.73|STANDARD_ERROR_OF_MEAN|0.371||0.049|TWO_SIDED|95.0|0.0|1.46|||ANCOVA|||||1.46|0.00|0.049
71070209|NCT01340027|141649022|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.94|STANDARD_ERROR_OF_MEAN|0.368||0.011|TWO_SIDED|95.0|0.22|1.66|||ANCOVA|||||1.66|0.22|0.011
71070210|NCT01340027|141649022|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.428||0.7|TWO_SIDED|95.0|-0.67|1.01|||ANCOVA|||||1.01|-0.67|0.70
71113442|NCT01092780|141734657|SUPERIORITY_OR_OTHER||Difference in LS means|-2.05|||||TWO_SIDED|90.0|-3.76|-0.35||||||Difference in LS means||-0.35|-3.76|
71070211|NCT01340027|141649022|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.73|STANDARD_ERROR_OF_MEAN|0.423||0.084|TWO_SIDED|95.0|-0.1|1.56|||ANCOVA|||||1.56|-0.10|0.084
71070212|NCT01340027|141649022|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.66|STANDARD_ERROR_OF_MEAN|0.425||0.12|TWO_SIDED|95.0|-0.18|1.49|||ANCOVA|||||1.49|-0.18|0.12
71113443|NCT01092780|141734657|SUPERIORITY_OR_OTHER||Difference in LS means|-2.1|||||TWO_SIDED|90.0|-3.79|-0.4||||||Difference in LS means||-0.40|-3.79|
71113444|NCT01092780|141734658|SUPERIORITY_OR_OTHER||Difference in LS means|10.21|||||TWO_SIDED|90.0|8.49|11.92||||||||11.92|8.49|
71113445|NCT01092780|141734659|SUPERIORITY_OR_OTHER||Difference in LS means|-0.07|||||TWO_SIDED|90.0|-0.08|-0.05||||||Difference in LS means||-0.05|-0.08|
71070213|NCT01340027|141649022|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.369||0.36|TWO_SIDED|95.0|-0.39|1.06|||ANCOVA|||||1.06|-0.39|0.36
71070214|NCT01340027|141649022|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.428||0.23|TWO_SIDED|95.0|-0.32|1.36|||ANCOVA|||||1.36|-0.32|0.23
71070215|NCT01340027|141649022|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.371||0.16|TWO_SIDED|95.0|-0.21|1.25|||ANCOVA|||||1.25|-0.21|0.16
71070216|NCT01340027|141649022|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.79|STANDARD_ERROR_OF_MEAN|0.371||0.032|TWO_SIDED|95.0|0.07|1.52|||ANCOVA|||||1.52|0.07|0.032
71070217|NCT01340027|141649022|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.03|STANDARD_ERROR_OF_MEAN|0.373||0.006|TWO_SIDED|95.0|0.3|1.76|||ANCOVA|||||1.76|0.30|0.006
71070218|NCT01340027|141649022|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.369||0.031|TWO_SIDED|95.0|0.07|1.52|||ANCOVA|||||1.52|0.07|0.031
71070219|NCT01340027|141649022|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.07|STANDARD_ERROR_OF_MEAN|0.423||0.012|TWO_SIDED|95.0|0.24|1.9|||ANCOVA|||||1.90|0.24|0.012
71070220|NCT01340027|141649022|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.28|STANDARD_ERROR_OF_MEAN|0.421||0.002|TWO_SIDED|95.0|0.45|2.1|||ANCOVA|||||2.10|0.45|0.002
71113446|NCT01864148|141734660|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9584|TWO_SIDED|95.0|0.46|2.07|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||2.07|0.46|0.9584
71113447|NCT01864148|141734660|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.79||||0.0636|TWO_SIDED|95.0|0.97|3.31|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||3.31|0.97|0.0636
71113448|NCT01864148|141734660|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06||||0.022|TWO_SIDED|95.0|1.11|3.84|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||3.84|1.11|0.0220
71113449|NCT01864148|141734660|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.1771|TWO_SIDED|95.0|0.36|1.21|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||1.21|0.36|0.1771
71113450|NCT01864148|141734660|SUPERIORITY_OR_OTHER|||||||0.8931|||||||Trend test|Trend test p-value is based on a linear contrast in logistic regression.||||||0.8931
71070221|NCT04687072|141649024|SUPERIORITY||Difference in percentage|-3.5||||0.5081|TWO_SIDED|95.0|-14.7|7.0||The p-value was calculated using the Cochran-Mantel-Haenszel test used in the hierarchical testing procedure.|Cochran-Mantel-Haenszel||The adjusted difference in percentages and 95% confidence interval (CI) (Klingenberg approach) were presented.|||7.0|-14.7|0.5081
71070222|NCT04687072|141649025|SUPERIORITY||Location shift|0.0||||0.4925|TWO_SIDED|95.0|0.0|0.0||The p-value was calculated using the stratified Mann-Whitney test used in the hierarchical testing procedure.|Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator of the treatment difference and 95% CI are presented.|||0.000|0.000|0.4925
71070223|NCT04687072|141649026|SUPERIORITY||Difference in percentage|-0.5||||0.9314|TWO_SIDED|95.0|-11.7|10.0||The p-value was calculated using the Cochran-Mantel-Haenszel test used in the hierarchical testing procedure.|Cochran-Mantel-Haenszel||The adjusted difference in percentages and 95% CI (Klingenberg approach) were presented.|||10.0|-11.7|0.9314
71070224|NCT04687072|141649027|SUPERIORITY||Difference in percentage|-1.7||||0.7379|TWO_SIDED|95.0|-12.4|8.2||The Cochran-Mantel-Haenszel test p-value was used in the hierarchical testing procedure.|Cochran-Mantel-Haenszel||The adjusted difference in percentage and 95% CI (Klingenberg approach) are presented.|||8.2|-12.4|0.7379
71070225|NCT04687072|141649028|OTHER||Difference in percentage|4.2|||||TWO_SIDED|95.0|-9.3|16.8|||||||The 95% Agresti-Min CIs are presented.|16.8|-9.3|
71070226|NCT04687072|141649029|SUPERIORITY||Location shift|0.0||||0.726|TWO_SIDED|95.0|0.0|0.0||The p-value was calculated using the stratified Mann-Whitney test.|Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator of the treatment difference and 95% CI are presented.|||0.000|0.000|0.7260
71070227|NCT04687072|141649030|OTHER||Difference in percentage|2.5|||||TWO_SIDED|95.0|-9.6|13.0|||||The 95% Agresti-Min CIs are presented.|||13.0|-9.6|
71070228|NCT04687072|141649033|SUPERIORITY||Location shift|0.0||||0.2929|TWO_SIDED|95.0|0.0|1.0||The p-value was calculated using the stratified Mann-Whitney test.|Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator of the treatment difference and 95% CI are presented.|||1.000|0.000|0.2929
71070229|NCT04687072|141649034|SUPERIORITY||Location shift|0.0||||0.1475|TWO_SIDED|95.0|0.0|1.0||The p-value was calculated using the stratified Mann-Whitney test.|Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator of the treatment difference and 95% CI are presented.|||1.000|0.000|0.1475
71070230|NCT04687072|141649035|SUPERIORITY||Location shift|0.0||||0.7677|TWO_SIDED|95.0|-2.0|2.0||The p-value was calculated using the stratified Mann-Whitney test used in the hierarchical testing procedure.|Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator of the treatment difference and 95% CI are presented.|WHO Classified Bleeding Event Grade ≥1||2.000|-2.000|0.7677
71070231|NCT04687072|141649036|OTHER||Difference in percentage|-1.2|||||TWO_SIDED|95.0|-11.8|7.3|||||The 95% Agresti-Min CIs are presented.|IWG Complete Response||7.3|-11.8|
71070232|NCT04687072|141649036|OTHER||Difference in percentage|8.5|||||TWO_SIDED|95.0|-4.6|20.2|||||The 95% Agresti-Min CIs are presented.|IWG Response||20.2|-4.6|
71070233|NCT04687072|141649036|OTHER||Difference in percentage|2.6|||||TWO_SIDED|95.0|-9.7|13.3|||||The 95% Agresti-Min CIs are presented.|Initial Response||13.3|-9.7|
71113451|NCT01864148|141734661|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.3058|TWO_SIDED|95.0|0.28|1.49|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||1.49|0.28|0.3058
71070234|NCT04687072|141649038|OTHER||Difference in percentage|-4.0|||||TWO_SIDED|95.0|-15.6|5.7|||||The 95% Agresti-Min CIs are presented.|||5.7|-15.6|
71070235|NCT00915876|141649048|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
71070236|NCT01662791|141649049|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||Comparison between the groups for \>12 ppm.||||1.0
71070237|NCT01662791|141649050|SUPERIORITY_OR_OTHER|||||||0.235|||||||Chi-squared|||Comparison between groups for mobility sub-scale.||||0.235
71070238|NCT01662791|141649050|SUPERIORITY_OR_OTHER|||||||0.206|||||||Chi-squared|||Comparison between groups for activities of daily living sub-scale.||||0.206
71070239|NCT01662791|141649050|SUPERIORITY_OR_OTHER|||||||0.641|||||||Chi-squared|||Comparison between groups for emotional well-being sub-scale.||||0.641
71070240|NCT01662791|141649050|SUPERIORITY_OR_OTHER|||||||0.446|||||||Chi-squared|||Comparison between groups for stigma sub-scale.||||0.446
71070241|NCT01662791|141649050|SUPERIORITY_OR_OTHER|||||||0.466|||||||Chi-squared|||Comparison between groups for social support sub-scale.||||0.466
71070242|NCT01662791|141649050|SUPERIORITY_OR_OTHER|||||||0.205|||||||Chi-squared|||Comparison between groups for cognition sub-scale.||||0.205
71070243|NCT01662791|141649050|SUPERIORITY_OR_OTHER|||||||0.153|||||||Chi-squared|||Comparison between groups for communication sub-scale.||||0.153
71070244|NCT01662791|141649050|SUPERIORITY_OR_OTHER|||||||0.73|||||||Chi-squared|||Comparison between groups for bodily discomfort sub-scale.||||0.730
71070245|NCT01662791|141649050|SUPERIORITY_OR_OTHER|||||||0.334|||||||Chi-squared|||Comparison between groups for summary index sub-scale.||||0.334
71070246|NCT01662791|141649051|SUPERIORITY_OR_OTHER|||||||0.167|||||||McNemar|||Comparison in case group between baseline and 3 months for mobility sub-scale.||||0.167
71070247|NCT01662791|141649051|SUPERIORITY_OR_OTHER|||||||0.159|||||||McNemar|||Comparison in case group between baseline and 3 months for activities of daily living sub-scale.||||0.159
71070248|NCT01662791|141649051|SUPERIORITY_OR_OTHER|||||||0.041|||||||McNemar|||Comparison in case group between baseline and 3 months for emotional well-being sub-scale.||||0.041
71070249|NCT01662791|141649051|SUPERIORITY_OR_OTHER|||||||0.19|||||||McNemar|||Comparison in case group between baseline and 3 months for stigma sub-scale.||||0.190
71070250|NCT01662791|141649051|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|||Comparison in case group between baseline and 3 months for social support sub-scale.||||1.0
71070251|NCT01662791|141649051|SUPERIORITY_OR_OTHER|||||||0.16|||||||McNemar|||Comparison in case group between baseline and 3 months for cognition sub-scale.||||0.160
71070252|NCT01662791|141649051|SUPERIORITY_OR_OTHER|||||||0.276|||||||McNemar|||Comparison in case group between baseline and 3 months for communication sub-scale.||||0.276
71070253|NCT01662791|141649051|SUPERIORITY_OR_OTHER|||||||0.351|||||||McNemar|||Comparison in case group between baseline and 3 months for bodily discomfort sub-scale.||||0.351
71070254|NCT01662791|141649051|SUPERIORITY_OR_OTHER|||||||0.186|||||||McNemar|||Comparison in case group between baseline and 3 months for summary index sub-scale.||||0.186
71070255|NCT01662791|141649052|SUPERIORITY_OR_OTHER|||||||0.303|||||||Chi-squared|||Comparison between groups for constipation sub-scale.||||0.303
71113452|NCT01864148|141734661|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.1873|TWO_SIDED|95.0|0.81|2.89|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||2.89|0.81|0.1873
71113453|NCT01864148|141734661|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.2766|TWO_SIDED|95.0|0.76|2.65|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||2.65|0.76|0.2766
71070256|NCT01662791|141649052|SUPERIORITY_OR_OTHER|||||||0.518|||||||Chi-squared|||Comparison between groups for dyspepsia sub-scale.||||0.518
71070257|NCT01662791|141649052|SUPERIORITY_OR_OTHER|||||||0.8|||||||Chi-squared|||Comparison between groups for abdominal discomfort sub-scale.||||0.800
71070258|NCT01662791|141649052|SUPERIORITY_OR_OTHER|||||||0.736|||||||Chi-squared|||Comparison between groups for diarrhea sub-scale.||||0.736
71070259|NCT01662791|141649052|SUPERIORITY_OR_OTHER|||||||0.57|||||||Chi-squared|||Comparison between groups for GERD sub-scale.||||0.570
71070260|NCT01662791|141649052|SUPERIORITY_OR_OTHER|||||||0.394|||||||Chi-squared|||Comparison between groups for nausea and vomiting sub-scale.||||0.394
71070261|NCT01662791|141649053|SUPERIORITY_OR_OTHER|||||||0.056|||||||McNemar|||Comparison in case group between baseline and 3 months for constipation sub-scale.||||0.056
71070262|NCT01662791|141649053|SUPERIORITY_OR_OTHER|||||||0.38|||||||McNemar|||Comparison in case group between baseline and 3 months for dyspepsia sub-scale.||||0.380
71113454|NCT01864148|141734661|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.6578|TWO_SIDED|95.0|0.45|1.65|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||1.65|0.45|0.6578
71113455|NCT01864148|141734661|SUPERIORITY_OR_OTHER|||||||0.5255|||||||Trend test|Trend test p-value is based on a linear contrast in logistic regression.||||||0.5255
71113456|NCT03587428|141734668|SUPERIORITY||Mean Difference (Final Values)|-0.3252||||0.1787|TWO_SIDED|95.0|-0.8101|0.1596|||ANCOVA|ANCOVA for treatment and period as fixed effects and subject as random effect and two baseline terms as covariates.|Difference is first named treatment minus second named treatment; a positive difference favors the first named treatment.|||0.1596|-0.8101|0.1787
71113457|NCT03587428|141734668|SUPERIORITY||Mean Difference (Final Values)|-0.7037||||0.0063|TWO_SIDED|95.0|-1.1886|-0.2187|||ANCOVA|ANCOVA for treatment and period as fixed effects and subject as random effect and two baseline terms as covariates.|Difference is first named treatment minus second named treatment; a positive difference favors the first named treatment.|||-0.2187|-1.1886|0.0063
71113458|NCT02689206|141734677|OTHER||Mean Difference (Final Values)|0.57|||||TWO_SIDED|95.0|-0.31|1.45|||||Analysis using a Repeated Measures Model with terms included for baseline, treatment, time and treatment\*time. Model-adjusted treatment difference of dapro 10 mg arm from Placebo along with 95 percent CI are presented.|||1.45|-0.31|
71070263|NCT01662791|141649053|SUPERIORITY_OR_OTHER|||||||0.244|||||||McNemar|||Comparison in case group between baseline and 3 months for abdominal discomfort sub-scale.||||0.244
71113459|NCT02689206|141734677|OTHER||Mean Difference (Final Values)|0.51|||||TWO_SIDED|95.0|-0.4|1.42|||||Analysis using a Repeated Measures Model with terms included for baseline, treatment, time and treatment\*time. Model-adjusted treatment difference of dapro 15 mg arm from Placebo along with 95 percent CI are presented.|||1.42|-0.40|
71070264|NCT01662791|141649053|SUPERIORITY_OR_OTHER|||||||0.279|||||||McNemar|||Comparison in case group between baseline and 3 months for diarrhea sub-scale.||||0.279
71070265|NCT01662791|141649053|SUPERIORITY_OR_OTHER|||||||0.554|||||||McNemar|||Comparison in case group between baseline and 3 months for GERD sub-scale.||||0.554
71070266|NCT01662791|141649053|SUPERIORITY_OR_OTHER|||||||0.351|||||||McNemar|||Comparison in case group between baseline and 3 months for nausea and vomiting sub-scale.||||0.351
71070267|NCT01662791|141649054|SUPERIORITY_OR_OTHER|||||||0.872|TWO_SIDED||||||t-test, 1 sided|||Comparison between the two groups at baseline for depression||||0.872
71070268|NCT01662791|141649054|SUPERIORITY_OR_OTHER|||||||0.835|TWO_SIDED||||||t-test, 1 sided|||Comparison between the two groups at baseline for anxiety.||||0.835
71070269|NCT01895270|141649089|SUPERIORITY||Slope|0.34|STANDARD_ERROR_OF_MEAN|0.42||0.42|TWO_SIDED||||||Mixed Models Analysis|||||||.42
71070270|NCT01098500|141649173|SUPERIORITY_OR_OTHER||Prevalence percentage|2.2|||||TWO_SIDED|95.0|0.9|3.5|||||Prevalence percentage is the number of patients with an ALT \>=3 times ULN divided by all patients that were tested at baseline (30 days prior to initiation of TKI drug).|||3.5|0.9|
71070271|NCT01098500|141649174|SUPERIORITY_OR_OTHER||Incidence Rate (IR)|6.2|||||TWO_SIDED|95.0|3.3|9.0|||||Incidence rate (IR) is the number of patients with an ALT \>=3 times ULN after initiation of TKI divided by person time contributed by all patients with normal ALT (\<1 times ULN) at baseline. IR expressed per 100 person years.|||9.0|3.3|
71070272|NCT01098500|141649175|SUPERIORITY_OR_OTHER||Prevalence percentage|0.4|||||TWO_SIDED|95.0|0.1|1.4|||||Prevalence percentage is the number of patients with Hy's Law divided by all patients that were tested at baseline (30 days prior to initiation of TKI drug).|||1.4|0.1|
71070273|NCT01098500|141649176|SUPERIORITY_OR_OTHER||Incidence Rate (IR)|0.4|||||TWO_SIDED|95.0|0.0|2.0|||||Incidence rate (IR) is the number of patients with Hy's Law after initiation of TKI divided by person time contributed by all patients with normal ALT, AST, ALP, and BIL (\< 1 times ULN) at baseline. IR is expressed per 100 person years.|||2.0|0.0|
71070274|NCT03628339|141649197|OTHER||% Ratio of Geometric Least square Mean|101.4|||||TWO_SIDED|90.0|89.35|115.06||||||||115.06|89.35|
71070275|NCT03628339|141649198|OTHER||% Ratio of Geometric Least square Mean|101.16|||||TWO_SIDED|90.0|89.24|114.66||||||||114.66|89.24|
71070276|NCT03628339|141649199|OTHER||% Ratio of Geometric Least square Mean|103.62|||||TWO_SIDED|90.0|86.91|123.56||||||||123.56|86.91|
71070277|NCT04507256|141649250|OTHER|Bioavailability|Ratio of geometric mean AUCinf|68.69|||||||||||||The bioavailability of AZD7442 Dose 1 administered by IM was, calculated as the ratio of geometric mean AUCinf after IM to IV, for mAb AZD8895.|Bioavailability of AZD8895 at the end of study (Day 361)||||
71113460|NCT02689206|141734677|OTHER||Mean Difference (Final Values)|1.47|||||TWO_SIDED|95.0|0.59|2.35|||||Analysis using a Repeated Measures Model with terms included for baseline, treatment, time and treatment\*time. Model-adjusted treatment difference of dapro 25 mg arm from Placebo along with 95 percent CI are presented.|||2.35|0.59|
71113461|NCT02689206|141734677|OTHER||Mean Difference (Final Values)|1.67|||||TWO_SIDED|95.0|0.77|2.57|||||Analysis using a Repeated Measures Model with terms included for baseline, treatment, time and treatment\*time. Model-adjusted treatment difference of dapro 30 mg arm from Placebo along with 95 percent CI are presented.|||2.57|0.77|
71070278|NCT04507256|141649250|OTHER|Bioavailability|Ratio of geometric mean AUCinf|65.02|||||||||||||The bioavailability of AZD7442 Dose 1 administered by IM was, calculated as the ratio of geometric mean AUCinf after IM to IV, for mAb AZD1061.|Bioavailability of AZD1061 at the end of study (Day 361)||||
71070279|NCT03330262|141649275|SUPERIORITY|||||||0.018|||||||Mixed Models Analysis|||||||0.018
71070280|NCT03330262|141649276|OTHER|Ho: mean change = 0||||||0.006|||||||Mixed Models Analysis|||||||0.006
71070281|NCT03330262|141649276|OTHER|Ho: mean change = 0||||||0.869|||||||Mixed Models Analysis|||||||0.869
71070282|NCT03330262|141649277|SUPERIORITY|||||||0.448|||||||Mixed Models Analysis|||||||0.448
71070283|NCT03330262|141649278|OTHER|This test evaluated whether the change in ABC was significant for the BALCAP condition##. Ho: mean = 0||||||0.273|||||||Mixed Models Analysis|||||||0.273
71070284|NCT03330262|141649278|OTHER|This test evaluated if the change in ABC score was significant for the control group.||||||0.796|||||||Mixed Models Analysis|||||||0.796
71070285|NCT03330262|141649279|OTHER|Ho: Mean change in score = 0||||||0.189|||||||Mixed Models Analysis|||||||0.189
71070286|NCT03330262|141649279|OTHER|Ho: mean change = 0||||||0.713|||||||Mixed Models Analysis|||||||0.713
71070287|NCT01647516|141649300|SUPERIORITY||Odds Ratio (OR)|3.262||||0.0482|TWO_SIDED|95.0|0.969|10.984|||Cochran-Mantel-Haenszel|Stratified by prior anti-tumor necrosing factor (anti-TNF) therapy experience, (yes or no).||||10.984|0.969|0.0482
71070288|NCT01647516|141649300|SUPERIORITY||Odds Ratio (OR)|2.5||||0.1422|TWO_SIDED|95.0|0.722|8.661|||Cochran-Mantel-Haenszel|Stratified by prior anti-tumor necrosing factor (anti-TNF) therapy experience, (yes or no).||||8.661|0.722|0.1422
71070289|NCT01647516|141649301|SUPERIORITY||Odds Ratio (OR)|2.158||||0.0207|TWO_SIDED|95.0|1.093|4.263|||Cochran-Mantel-Haenszel|Stratified by prior anti-tumor necrosing factor (anti-TNF) therapy experience, (yes or no).||||4.263|1.093|0.0207
71070290|NCT01647516|141649301|SUPERIORITY||Odds Ratio (OR)|1.947||||0.0648|TWO_SIDED|95.0|0.961|3.946|||Cochran-Mantel-Haenszel|Stratified by prior anti-tumor necrosing factor (anti-TNF) therapy experience, (yes or no).||||3.946|0.961|0.0648
71070291|NCT01647516|141649302|SUPERIORITY|||||||0.0042|||||||ANCOVA|The analysis of covariance model, adjusting for baseline Mayo score and prior anti-TNF (yes or no).||||||0.0042
71070292|NCT01647516|141649302|SUPERIORITY|||||||0.1415|||||||ANCOVA|The analysis of covariance model, adjusting for baseline Mayo score and prior anti-TNF (yes or no).||||||0.1415
71070293|NCT01647516|141649303|SUPERIORITY||Odds Ratio (OR)|3.861||||0.0023|TWO_SIDED|95.0|1.572|9.484|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||9.484|1.572|0.0023
71070294|NCT01647516|141649303|SUPERIORITY||Odds Ratio (OR)|2.647||||0.0348|TWO_SIDED|95.0|1.058|6.621|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||6.621|1.058|0.0348
71070295|NCT01647516|141649304|SUPERIORITY||Odds Ratio (OR)|4.332||||0.0108|TWO_SIDED|95.0|1.323|14.186|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||14.186|1.323|0.0108
71070296|NCT01647516|141649304|SUPERIORITY||Odds Ratio (OR)|5.443||||0.0021|TWO_SIDED|95.0|1.706|17.365|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||17.365|1.706|0.0021
71070297|NCT01647516|141649305|SUPERIORITY|Stratified by prior anti-TNF therapy experience, (yes or no).|Odds Ratio (OR)|4.03||||0.0002|TWO_SIDED|95.0|1.871|8.678|||Cochran-Mantel-Haenszel|||||8.678|1.871|0.0002
71070298|NCT01647516|141649305|SUPERIORITY||Odds Ratio (OR)|2.154||||0.0571|TWO_SIDED|95.0|0.974|4.763|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||4.763|0.974|0.0571
71070299|NCT01647516|141649306|SUPERIORITY||Odds Ratio (OR)|3.557||||0.0046|TWO_SIDED|95.0|1.444|8.762|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||8.762|1.444|0.0046
71070300|NCT01647516|141649306|SUPERIORITY||Odds Ratio (OR)|3.428||||0.0064|TWO_SIDED|95.0|1.384|8.494|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||8.494|1.384|0.0064
71070301|NCT03886519|141649312|SUPERIORITY||Odds Ratio (OR)|0.73||||0.07|TWO_SIDED|95.0|0.52|1.03||The a priori threshold for statistical significance is \<0.05.|Regression, Logistic|Adjusted for correlation between 2 eyes of a participant and baseline trichiasis severity.||||1.03|0.52|0.07
71070302|NCT04964544|141649325|OTHER||Percentage|90.7|||||TWO_SIDED|95.0|88.9|92.3|||||Proportion of participants|Proportion of participants with overall correct initial TASS assessment, with mitigations, worst case imputation (Self-Selection Population)||92.3|88.9|
71070303|NCT04964544|141649326|OTHER||Percentage|98.1|||||TWO_SIDED|95.0|97.1|98.8|||||Proportion of participants|Proportion of participants with overall correct final TASS assessment, with mitigations, worst case imputation (Per Protocol Population)||98.8|97.1|
71070304|NCT04964544|141649327|OTHER||Mean percent change from paseline|-35.48|||||TWO_SIDED|95.0|-36.63|-34.33||||||||-34.33|-36.63|
71070305|NCT02833844|141649345|SUPERIORITY||treatment difference|-56.92|STANDARD_ERROR_OF_MEAN|2.36|<|0.0001|TWO_SIDED|95.0|-61.55|-52.28||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-52.28|-61.55|< 0.0001
71070306|NCT02833844|141649346|SUPERIORITY||treatment difference|-75.2|STANDARD_ERROR_OF_MEAN|3.5|<|0.0001|TWO_SIDED|95.0|-82.1|-68.4||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-68.4|-82.1|< 0.0001
71070307|NCT02833844|141649347|SUPERIORITY||treatment difference|65.4|||<|0.0001|TWO_SIDED|95.0|57.8|71.1||Based on Cochran-Mantel-Haenszel test stratified by statin use stratification factor. For testing, nonachievement was imputed for participants with a missing value.|Cochran-Mantel-Haenszel|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as reference.|Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.||71.1|57.8|< 0.0001
71079371|NCT02087943|141666392|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Proportion|-2.7||||0.4938|TWO_SIDED|95.0|-10.2|4.8||Adjusted treatment differences in proportions using the weighted average of the treatment differences across the stratum of baseline EASI score stratification (≤ 20, \> 20) with, Cochran-Mantel-Haenszel (CMH) weights.|Cochran-Mantel-Haenszel||2-sided 95% Confidence Intervals (CI) is based on a normal approximation to the weighted average.|||4.8|-10.2|0.4938
70939023|NCT00896389|141378765|OTHER|Association between genotypes and phenotypes were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.||||>0.05
70939024|NCT00896389|141378766|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||<|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||||||<0.05
70939025|NCT00896389|141378767|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35909607 genotype group and phenotypes collected in this study.||||>0.05
70939026|NCT00896389|141378768|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35909607 genotype group and phenotypes collected in this study.||||>0.05
70939027|NCT00896389|141378769|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35909607 genotype group and phenotypes collected in this study.||||>0.05
70939028|NCT00896389|141378770|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.||||>0.05
71070308|NCT02833844|141649348|SUPERIORITY||treatment difference|71.9|||<|0.0001|TWO_SIDED|95.0|65.7|76.7||Based on Cochran-Mantel-Haenszel test stratified by statin use stratification factor. For testing, nonachievement was imputed for participants with a missing value.|Cochran-Mantel-Haenszel|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as a reference.|Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.||76.7|65.7|< 0.0001
71070309|NCT02833844|141649349|SUPERIORITY||treatment difference|-50.94|STANDARD_ERROR_OF_MEAN|2.01|<|0.0001|TWO_SIDED|95.0|-54.88|-46.99||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-46.99|-54.88|< 0.0001
71113462|NCT00595881|141734723|SUPERIORITY_OR_OTHER||Difference in sensitivity|-1.7|||||TWO_SIDED|95.0|-3.4|0.0||"We calculated the differences between the sensitivities and specificities. The difference in sensitivity between the clinical exam alone vs clinical exam + ultrasound was -1.7% (-3.4%, 0%).~The difference in specificity was -2.8% (-9.7%, 4.1%)."|Mixed effects logistic regression|We used the bootstrap method to obtain valid confidence intervals and compare sensitivity and specificity for the 2 tests.|The clinical exam alone was compared to the clinical exam + ultrasound.|See sample size calculations already entered. Null hypothesis is that there is no difference in the sensitivity or specificity of clinical exam alone compared with clinical exam+ultrasound.||0|-3.4|
70852831|NCT03456882|141194470|SUPERIORITY|||||||0.5239||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.5239
71070310|NCT02833844|141649350|SUPERIORITY||treatment difference|-47.73|STANDARD_ERROR_OF_MEAN|1.72|<|0.0001|TWO_SIDED|95.0|-51.11|-44.35||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-44.35|-51.11|< 0.0001
71113463|NCT00595881|141734723|SUPERIORITY_OR_OTHER||Difference in specificity|-2.8||||||95.0|-9.7|4.1||Statistical significance was defined as a CI surrounding the difference between groups not including 0.||as previously described for sensitivity||as previously described for sensitivity||4.1|-9.7|
71070311|NCT02833844|141649351|SUPERIORITY||treatment difference|-38.12|STANDARD_ERROR_OF_MEAN|1.62|<|0.0001|TWO_SIDED|95.0|-41.3|-34.94||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-34.94|-41.30|< 0.0001
71070312|NCT02833844|141649352|SUPERIORITY||treatment difference|-26.78|STANDARD_ERROR_OF_MEAN|3.76|<|0.0001|TWO_SIDED|95.0|-34.17|-19.4||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-19.40|-34.17|< 0.0001
71070313|NCT02833844|141649353|SUPERIORITY||treatment difference|-22.46|STANDARD_ERROR_OF_MEAN|4.36|<|0.0001|TWO_SIDED|95.0|-31.03|-13.88||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-13.88|-31.03|< 0.0001
71070314|NCT02833844|141649354|SUPERIORITY||treatment difference|8.36|STANDARD_ERROR_OF_MEAN|1.8|<|0.0001|TWO_SIDED|95.0|4.83|11.89||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||11.89|4.83|< 0.0001
71070315|NCT02833844|141649355|SUPERIORITY||treatment difference|-22.15|STANDARD_ERROR_OF_MEAN|4.01|<|0.0001|TWO_SIDED|95.0|-30.04|-14.26||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-14.26|-30.04|< 0.0001
71070316|NCT01899742|141649356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|||<|0.001|TWO_SIDED|95.0|0.045|0.131|||Mixed Models Analysis|||||0.131|0.045|<0.001
71070317|NCT01899742|141649357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073||||0.004|TWO_SIDED|95.0|0.024|0.122|||Mixed Models Analysis|||||0.122|0.024|0.004
71070318|NCT02195310|141649428|SUPERIORITY|||||||0.7007|||||||Fisher Exact Test (2-sided)|||||||0.7007
71070319|NCT01154088|141649429|NON_INFERIORITY|Criterion for non-inferiority: For each serogroup separately, the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (Nimenrix-A Group minus Mencevax Group) in the percentage of subjects with bactericidal vaccine response would be greater than or equal to (≥) the pre-defined clinical limit of -10%.|Difference in vaccine response rate|5.42|||||TWO_SIDED|95.0|-1.41|12.25||||||Demonstration of the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine (Nimenrix Lot A) when compared to the licensed Mencevax for Neisseria meningitidis (N. meningitidis) serogroups A as measured by serum bactericidal antibodies using baby rabbit complement (rSBA) at GSK.||12.25|-1.41|
71070320|NCT01154088|141649429|NON_INFERIORITY|Criterion for non-inferiority: For each serogroup separately, the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (Nimenrix-A Group minus Mencevax Group) in the percentage of subjects with bactericidal vaccine response would be greater than or equal to (≥) the pre-defined clinical limit of -10%.|Difference in vaccine response rate|-0.41|||||TWO_SIDED|95.0|-4.11|3.25||||||Demonstration of the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine (Nimenrix Lot A) when compared to the licensed Mencevax for Neisseria meningitidis (N. meningitidis) serogroups C as measured by serum bactericidal antibodies using baby rabbit complement (rSBA) at GSK.||3.25|-4.11|
71070321|NCT01154088|141649429|NON_INFERIORITY|Criterion for non-inferiority: For each serogroup separately, the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (Nimenrix-A Group minus Mencevax Group) in the percentage of subjects with bactericidal vaccine response would be greater than or equal to (≥) the pre-defined clinical limit of -10%.|Difference in vaccine response rate|6.83|||||TWO_SIDED|95.0|3.28|10.78||||||Demonstration of the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine (Nimenrix Lot A) when compared to the licensed Mencevax for Neisseria meningitidis (N. meningitidis) serogroups W-135 as measured by serum bactericidal antibodies using baby rabbit complement (rSBA) at GSK.||10.78|3.28|
71070322|NCT01154088|141649429|NON_INFERIORITY|Criterion for non-inferiority: For each serogroup separately, the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (Nimenrix-A Group minus Mencevax Group) in the percentage of subjects with bactericidal vaccine response would be greater than or equal to (≥) the pre-defined clinical limit of -10%.|Difference in vaccine response rate|7.02|||||TWO_SIDED|95.0|2.63|11.58||||||Demonstration of the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine (Nimenrix Lot A) when compared to the licensed Mencevax for Neisseria meningitidis (N. meningitidis) serogroups Y as measured by serum bactericidal antibodies using baby rabbit complement (rSBA) at GSK.||11.58|2.63|
71070323|NCT01154088|141649430|NON_INFERIORITY|Criterion for non-inferiority: Non-inferiority of Nimenrix Lot B vs. Nimenrix Lot A in terms of non-inferiority would be demonstrated if the upper limit (UL) of the 2-sided 95% CIs on the rSBA GMT ratios (GMTs of Nimenrix Lot B over the GMTs of the Nimenrix Lot A) would be below (\<) a limit of 2-fold for antibodies against all meningococcal serogroups.|Adjusted GMT ratio|1.04|||||TWO_SIDED|95.0|0.92|1.17||||||Demonstration of the comparability of the immunogenicity of Lot A to Lot B of Nimenrix conjugate vaccine with respect to rSBA geometric mean titres (GMTs) for N. meningitidis serogroups A, 1 month after vaccination as measured at GSK.||1.17|0.92|
71070324|NCT01154088|141649430|NON_INFERIORITY|Criterion for non-inferiority: Non-inferiority of Nimenrix Lot B vs. Nimenrix Lot A in terms of non-inferiority would be demonstrated if the upper limit (UL) of the 2-sided 95% CIs on the rSBA GMT ratios (GMTs of Nimenrix Lot B over the GMTs of the Nimenrix Lot A) would be below (\<) a limit of 2-fold for antibodies against all meningococcal serogroups.|Adjusted GMT ratio|1.15|||||TWO_SIDED|95.0|0.96|1.37||||||Demonstration of the comparability of the immunogenicity of Lot A to Lot B of Nimenrix conjugate vaccine with respect to rSBA geometric mean titres (GMTs) for N. meningitidis serogroups C, 1 month after vaccination as measured at GSK.||1.37|0.96|
71113464|NCT01479764|141734724|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.059|||Pearson's Chi-square test|||Sugammadex is the numerator and Neostigmine/Glycopyrrolate is the denominator.||0.059|0.000|<0.0001
71070325|NCT01154088|141649430|NON_INFERIORITY|Criterion for non-inferiority: Non-inferiority of Nimenrix Lot B vs. Nimenrix Lot A in terms of non-inferiority would be demonstrated if the upper limit (UL) of the 2-sided 95% CIs on the rSBA GMT ratios (GMTs of Nimenrix Lot B over the GMTs of the Nimenrix Lot A) would be below (\<) a limit of 2-fold for antibodies against all meningococcal serogroups.|Adjusted GMT ratio|0.91|||||TWO_SIDED|95.0|0.8|1.04||||||Demonstration of the comparability of the immunogenicity of Lot A to Lot B of Nimenrix conjugate vaccine with respect to rSBA geometric mean titres (GMTs) for N. meningitidis serogroups W-135, 1 month after vaccination as measured at GSK.||1.04|0.8|
70852832|NCT03456882|141194470|SUPERIORITY||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.12||0.4401|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.4401
71070326|NCT01154088|141649430|NON_INFERIORITY|Criterion for non-inferiority: Non-inferiority of Nimenrix Lot B vs. Nimenrix Lot A in terms of non-inferiority would be demonstrated if the upper limit (UL) of the 2-sided 95% CIs on the rSBA GMT ratios (GMTs of Nimenrix Lot B over the GMTs of the Nimenrix Lot A) would be below (\<) a limit of 2-fold for antibodies against all meningococcal serogroups.|Adjusted GMT ratio|0.88|||||TWO_SIDED|95.0|0.78|0.99||||||Demonstration of the comparability of the immunogenicity of Lot A to Lot B of Nimenrix conjugate vaccine with respect to rSBA geometric mean titres (GMTs) for N. meningitidis serogroups Y, 1 month after vaccination as measured at GSK.||0.99|0.78|
71070327|NCT01869699|141649459|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.002|TWO_SIDED|95.0|-0.76|-0.18|||ANCOVA|||We estimated that 20 patients per group would provide 80% power for detecting a difference in means of 0.6 degrees Celsius, with a pooled SD of 0.67 degrees, using a two group t test and a two sided alpha level of 0.05. A previous RCT of IV acetaminophen in healthy male volunteers with induced fever found a core temperature difference of 0.60 degrees with a common SD of 0.67 degrees Celsius.||-0.18|-0.76|0.002
71113465|NCT01479764|141734725|SUPERIORITY_OR_OTHER||Estimated Ratio of Geometric Means|0.83||||0.021|TWO_SIDED|95.0|0.71|0.97|||ANCOVA|Adjusted for age, American Society of Anesthesiologists class, Body Mass Index, comorbidity index \& length of surgical procedure||Sugammadex is the numerator and neostigmine/glycopyrrolate is the denominator. Used log-transformed time intervals.||0.97|0.71|0.021
70852833|NCT03456882|141194471|SUPERIORITY||difference between mean slopes|0.02|STANDARD_ERROR_OF_MEAN|0.04||0.5725|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction||Contrast of the slopes during the on-treatment period (change per week, from baseline to week 24) between treatment groups. Null hypothesis: the rate of change from baseline to week 24 is not different between groups.||||0.5725
70852834|NCT03456882|141194471|SUPERIORITY||difference between mean slopes|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.5728|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|Contrast of the slopes during the off-treatment follow-up period (change per week, from week 24 to week 48) between treatment groups. Null hypothesis: the rate of change from week 24 to week 48 is not different between groups.||||0.5728
70852835|NCT03456882|141194472|SUPERIORITY|||||||0.9212||||||Significance level set to 0.05|Log Rank|||Null hypothesis: the survival curves over the on-treatment and the off-treatment follow-up period are not different between groups.||||0.9212
70852836|NCT03456882|141194473|SUPERIORITY||difference between mean slopes|0.41|STANDARD_ERROR_OF_MEAN|0.16||0.0101|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|Contrast of the slopes during the on-treatment period (change per week, from baseline to week 24) between treatment groups. Null hypothesis: the rate of change from baseline to week 24 is not different between groups.||||0.0101
70852837|NCT03456882|141194473|SUPERIORITY||difference between mean slopes|0.09|STANDARD_ERROR_OF_MEAN|0.18||0.5924|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|Contrast of the slopes during the off-treatment follow-up period (change per week, from week 24 to week 48) between treatment groups. Null hypothesis: the rate of change from week 24 to week 48 is not different between groups.||||0.5924
70852838|NCT03456882|141194474|SUPERIORITY|||||||0.9598||||||Significance level set to 0.05|Fisher Exact|||AE treatment discontinuation 4 weeks. Null hypothesis: the percentage of patients experiencing at least one adverse event leading to treatment discontinuation within 4 weeks is not different between groups||||0.9598
70852839|NCT03456882|141194474|SUPERIORITY|||||||0.939||||||Significance level set to 0.05|Fisher Exact|||AE treatment discontinuation 12 weeks. Null hypothesis: the percentage of patients experiencing at least one adverse event leading to treatment discontinuation within 12 weeks is not different between groups||||0.9390
70852840|NCT03456882|141194474|SUPERIORITY|||||||0.3442||||||Significance level set to 0.05|Fisher Exact|||AE treatment discontinuation 24 weeks. Null hypothesis: the percentage of patients experiencing at least one adverse event leading to treatment discontinuation within 24 weeks is not different between groups||||0.3442
70852841|NCT03456882|141194475|SUPERIORITY||difference between mean slopes|-0.13|STANDARD_ERROR_OF_MEAN|0.1||0.1503|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|ALSAQ-40 physical mobility. Contrast of the slopes during the on-treatment and off-treatment follow-up period (change per week, from baseline to week 48) between treatment groups. Null hypothesis: the rate of change from baseline to week 48 is not different between groups.||||0.1503
71070328|NCT01869699|141649460|SUPERIORITY||Mean Difference (Final Values)|-6.0||||0.03|TWO_SIDED|95.0|-10.0|-1.0|||ANCOVA|||||-1|-10|0.03
71113466|NCT00260832|141734728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1079|TWO_SIDED|95.0|||||Kaplan-Meier|||The primary treatment comparison was based on two sided long-rank test stratified by age, cytogenetic risk, ECOG performance status||||0.1079
71113467|NCT00260832|141734729|SUPERIORITY||Odds Ratio (OR)|2.5||||0.0011|TWO_SIDED|95.0|1.4|4.78|||Fisher Exact|||||4.78|1.40|0.0011
71070329|NCT01869699|141649461|SUPERIORITY||Mean Difference (Final Values)|-17.0|||<|0.001|TWO_SIDED|95.0|-25.0|-8.0|||ANCOVA|||||-8|-25|<0.001
71070330|NCT01869699|141649462|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.42|TWO_SIDED|95.0|-4.0|12.0|||ANCOVA|||||12|-4|0.42
71070331|NCT01869699|141649463|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.002|TWO_SIDED|95.0|-1.0|-0.3|||ANCOVA|||||-0.3|-1|0.002
71070332|NCT01869699|141649464|SUPERIORITY||Mean Difference (Final Values)|-24.0||||0.001|TWO_SIDED|95.0|-38.0|-10.0|||ANCOVA|||||-10|-38|0.001
71070333|NCT01869699|141649465|SUPERIORITY||Mean Difference (Final Values)|-8.0||||0.02|TWO_SIDED|95.0|-15.0|-1.0|||ANCOVA|||||-1|-15|0.02
71070334|NCT02017912|141649489|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.5567||0.7208|TWO_SIDED|95.0|-1.321|0.92|||Mixed Models Analysis|||||0.920|-1.321|0.7208
71070335|NCT02017912|141649490|SUPERIORITY||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.881||0.641|TWO_SIDED|95.0|-2.187|1.36|||Mixed Models Analysis|||||1.360|-2.187|0.6410
71070336|NCT01508130|141649500|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.08||||0.6451|TWO_SIDED|95.0|0.78|1.49|||Wald residual chi-square test||Due to the non-interventional study design, the Cox model included a propensity score as a covariate (incorporated important demographics and baseline characteristics) to account for the potential imbalance between treatment groups.|||1.49|0.78|0.6451
71070337|NCT01508130|141649500|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.02||||0.8826|TWO_SIDED|95.0|0.78|1.34|||Wald residual chi-square test||Without Propensity Score as a Covariate.|||1.34|0.78|0.8826
71070338|NCT01508130|141649501|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.7695|TWO_SIDED|95.0|0.58|1.49|||Multiple Logistic Regression||A multiple logistic regression model including a propensity score as a covariate (incorporated important demographics and baseline characteristics) was used for the treatment comparison.|||1.49|0.58|0.7695
71070339|NCT01508130|141649501|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.2594|TWO_SIDED|95.0|0.84|1.92|||Multiple Logistic Regression||Without Propensity Score as a Covariate|||1.92|0.84|0.2594
71070340|NCT01508130|141649508|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.03||||0.9156|TWO_SIDED|95.0|0.64|1.64|||Wald residual chi-square test||95% CI for median was computed using the method of Brookmeyer and Crowley.|||1.64|0.64|0.9156
71070341|NCT01508130|141649509|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.5649|TWO_SIDED|95.0|0.57|1.36|||Wald residual chi-square test||95% CI for median was computed using the method of Brookmeyer and Crowley.|||1.36|0.57|0.5649
71070342|NCT03403751|141649530|SUPERIORITY|||||||0.649|||||||Chi-squared|||||||0.649
71070343|NCT03403751|141649533|SUPERIORITY|||||||0.871|||||||Chi-squared|||||||0.871
71070344|NCT03403751|141649534|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.420
71070345|NCT03403751|141649535|SUPERIORITY|||||||0.448|||||||Wilcoxon (Mann-Whitney)|||||||0.448
71070346|NCT03403751|141649536|SUPERIORITY|||||||0.579|||||||Wilcoxon (Mann-Whitney)|||||||0.579
71070347|NCT03403751|141649537|SUPERIORITY|||||||0.227|||||||Wilcoxon (Mann-Whitney)|||||||0.227
71070348|NCT03403751|141649540|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71070349|NCT03403751|141649541|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71070350|NCT03403751|141649542|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71070351|NCT03403751|141649543|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
71070352|NCT00750139|141649546|SUPERIORITY_OR_OTHER|||||||0.01||||||The first primary efficacy analyses will use the Cochran-Mantel-Haenszel (CMH) test after stratification by pooled clinical site. The test will be conducted with the FAS at a one-sided level of significance of α = 0.025.|Cochran-Mantel-Haenszel|||"The first primary efficacy hypotheses tests are:~H01: p1 ≤ p01 vs. H1: p1 \> p01 where p01 and p1 denote the proportions of complete cure in the placebo 2wks and NAFT-500 groups, respectively."||||0.010
71070353|NCT00750139|141649546|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||The second primary efficacy analyses will use the Cochran-Mantel-Haenszel (CMH) test after stratification by pooled clinical site. The test will be conducted with the FAS at a one-sided level of significance of α = 0.025|Cochran-Mantel-Haenszel|||"The second primary efficacy hypotheses tests are:~H02: p2 ≤ P02 vs. H2: P2 \> p02 where p02 and p2 are denote proportions of complete cure in the placebo 4wks and Naftin 1% groups, respectively"||||0.001
71070354|NCT03518619|141649564|OTHER|This is a single group design. Paired-samples t-tests were conducted.|||||<|0.05||||||This is a calculated p-value.|t-test, 2 sided|||||||<.05
71070355|NCT03518619|141649565|OTHER|This is a single group design. Paired-samples t-tests were conducted.|||||<|0.01||||||This is a calculated p-value.|t-test, 2 sided|||||||<.01
71070356|NCT03875482|141649692|SUPERIORITY||Mean Difference|59.0|||<|0.001|TWO_SIDED|95.0|48.4|69.6|||Chi-squared|||The variable was analyzed using the Chi-square test. Both null hypotheses corresponding to the co-primary endpoints must be rejected simultaneously under a two-sided significance level of 0.05.||69.6|48.4|<0.001
71070357|NCT03875482|141649693|SUPERIORITY||Mean Difference|68.5|||<|0.001|TWO_SIDED|95.0|57.2|79.7|||Chi-squared|||The variable was analyzed using the Chi-square test. Both null hypotheses corresponding to the co-primary endpoints must be rejected simultaneously under a two-sided significance level of 0.05.||79.7|57.2|<0.001
71070358|NCT03875482|141649694|SUPERIORITY||Mean Difference|36.2|||<|0.001|TWO_SIDED|95.0|26.2|46.2|||Chi-squared|||The ranked secondary efficacy endpoints at Week 16 were to be tested between the risankizumab and placebo treatment groups among the ITT Population in a hierarchical order only if the null hypotheses for both primary endpoints had been rejected.||46.2|26.2|<0.001
71070359|NCT03875482|141649695|SUPERIORITY||Mean Difference|37.1|||<|0.001|TWO_SIDED|95.0|27.1|47.2|||Chi-squared|||The ranked secondary efficacy endpoints at Week 16 were to be tested between the risankizumab and placebo treatment groups among the ITT Population in a hierarchical order only if the null hypotheses for both primary endpoints and for the first secondary endpoint had been rejected.||47.2|27.1|<0.001
71070360|NCT03875482|141649696|SUPERIORITY||LS Mean Difference|-36.14|STANDARD_ERROR_OF_MEAN|4.956|<|0.001|TWO_SIDED|95.0|-45.936|-26.346|||Mixed-effect Model Repeat Measurements||Risankizumab - placebo|"Risankizumab vs placebo at Week 4~Mixed-effect Model Repeat Measurements (MMRM): The repeated measures analysis was conducted using a mixed model including the baseline value and observed measurements at all post-baseline visits. The mixed model included the categorical fixed effects of treatment, visit and treatment-by-visit interaction as covariates."||-26.346|-45.936|<0.001
70939029|NCT00896389|141378771|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.||||>0.05
70939030|NCT00896389|141378772|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.||||>0.05
71070361|NCT03875482|141649696|SUPERIORITY||LS Mean Difference|-59.97|STANDARD_ERROR_OF_MEAN|5.326|<|0.001|TWO_SIDED|95.0|-70.501|-49.439|||Mixed-effect Model Repeat Measurements||Risankizumab - placebo|"Risankizumab vs placebo at Week 16~Mixed-effect Model Repeat Measurements (MMRM): The repeated measures analysis was conducted using a mixed model including the baseline value and observed measurements at all post-baseline visits. The mixed model included the categorical fixed effects of treatment, visit and treatment-by-visit interaction as covariates."||-49.439|-70.501|<0.001
71070362|NCT00979875|141649704|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|2.08|||<|0.0001|TWO_SIDED|90.0|1.7|2.55||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|Mixed Models Analysis|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||2.55|1.70|<0.0001
71070363|NCT00979875|141649704|SUPERIORITY_OR_OTHER||Geometric Least Squares Means Ratio|5.26|||<|0.0001|TWO_SIDED|90.0|3.88|7.12||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|Mixed Models Analysis|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||7.12|3.88|<0.0001
71070364|NCT00979875|141649704|SUPERIORITY_OR_OTHER||Geometric Least Squares Means Ratio|4.14|||<|0.0001|TWO_SIDED|90.0|3.05|5.6||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|Mixed Models Analysis|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||5.60|3.05|<0.0001
71070365|NCT00979875|141649705|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-38.93|||<|0.0001|TWO_SIDED|90.0|-53.31|-24.55||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||-24.55|-53.31|<0.0001
71070366|NCT00979875|141649705|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-26.43||||0.0032|TWO_SIDED|90.0|-40.81|-12.05||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||-12.05|-40.81|0.0032
71070367|NCT00979875|141649705|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-42.14|||<|0.0001|TWO_SIDED|90.0|-56.53|-27.76||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||-27.76|-56.53|<0.0001
71070368|NCT02738879|141649710|NON_INFERIORITY|Hypothesis A: After 30 weeks, continuing sitagliptin is non-inferior relative to withdrawing sitagliptin on the change from baseline in A1C. Non-inferiority is declared if the upper bound of the two-sided 95% CI for the difference is less than 0.3%.|Between Group Difference in the LSM|-0.46|||||TWO_SIDED|95.0|-0.58|-0.34|||LDA|||A longitudinal data analysis (LDA) model included terms for treatment, AHA treatment at screening (Met + DPP-4i, Met + DPP-4i + SU, Met + SU), time, and the interactions of time by treatment and of time by AHA treatment at screening. Least Squares Means = LSM||-0.34|-0.58|
71070369|NCT02738879|141649710|SUPERIORITY|Hypothesis B: After 30 weeks, continuing sitagliptin results in a greater reduction of A1C relative to withdrawing sitagliptin.|Between Group Difference in the LSM|-0.46|||<|0.001|TWO_SIDED|95.0|-0.58|-0.34|||LDA|||A LDA model included terms for treatment, AHA treatment at screening (Met + DPP-4i, Met + DPP-4i + SU, Met + SU), time, and the interactions of time by treatment and of time by AHA treatment at screening.||-0.34|-0.58|< 0.001
71070370|NCT02738879|141649711|SUPERIORITY||Event Rate Ratio|0.73|||=|0.039|TWO_SIDED|95.0|0.54|0.98|||Negative Binomial Model|||Calculated via the Negative Binomial Model including terms for treatment, race (i.e., White and Other), region (i.e., Europe, North America, and Other), AHA treatment at screening, baseline A1C value and baseline body weight and an offset for follow-up time (on the natural log scale).||0.98|0.54|= 0.039
71070371|NCT02738879|141649712|OTHER|95% CI|Between Group Difference in Percentages|-0.3|||||TWO_SIDED|95.0|-2.3|1.7|||Miettinen & Nurminen|||||1.7|-2.3|
71070372|NCT02738879|141649713|SUPERIORITY||Between Group Difference in Percentages|-4.1|||=|0.25|TWO_SIDED|95.0|-11.2|2.9|||Miettinen and Nurminen|||||2.9|-11.2|= 0.250
71113468|NCT03745638|141734730|SUPERIORITY||Odds Ratio (OR)|6.38|||<|0.0001|TWO_SIDED|95.0|3.556|11.923||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||11.923|3.556|< 0.0001
71113469|NCT03745638|141734730|SUPERIORITY||Odds Ratio (OR)|7.5|||<|0.0001|TWO_SIDED|95.0|4.178|14.04||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||14.040|4.178|< 0.0001
71070373|NCT02738879|141649714|SUPERIORITY||Between Group Difference in the LSM|-8.0|||=|0.016|TWO_SIDED|95.0|-14.6|-1.5|||LDA model|||The analysis is based on a LDA model including terms for treatment, AHA treatment at screening (Met + DPP-4i, Met + DPP-4i + SU, Met + SU), time, and the interactions of time by treatment and of time by AHA treatment at screening.||-1.5|-14.6|= 0.016
71070374|NCT02738879|141649715|SUPERIORITY||Event Rate Ratio|0.81|||=|0.041|TWO_SIDED|95.0|0.67|0.99|||Negative Binomial Model|||Negative Binomial Model including terms for treatment, race (i.e., White and Other), region (i.e., Europe, North America, and Other), AHA treatment at screening, baseline A1C value and baseline body weight and an offset for follow-up time (on the natural log scale).||0.99|0.67|= 0.041
71070375|NCT02738879|141649716|SUPERIORITY||Event Rate Ratio|0.83|||=|0.473|TWO_SIDED|95.0|0.51|1.37|||Negative Binomial Model|||Negative Binomial Model including terms for treatment, race (i.e., White and Other), region (i.e., Europe, North America, and Other), AHA treatment at screening, baseline A1C value and baseline body weight and an offset for follow-up time (on the natural log scale).||1.37|0.51|= 0.473
71113470|NCT03745638|141734731|SUPERIORITY||Odds Ratio (OR)|4.04|||<|0.0001|TWO_SIDED|95.0|2.441|6.808||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||6.808|2.441|< 0.0001
71070376|NCT02738879|141649717|SUPERIORITY||Between Group Difference in Percentages|-1.2|||=|0.624|TWO_SIDED|95.0|-6.2|3.7|||Miettinen and Nurminen|||Percentages and difference in percentages were calculated via the Miettinen and Nurminen stratified by AHA treatment at screening. Includes imputed events after participants discontinued from the study medication, using a Gamma frailty model. The bootstrap method was used to obtain the CI and p-value.||3.7|-6.2|= 0.624
71070377|NCT02738879|141649718|SUPERIORITY||Between Group Difference in Percentages|18.8|||<|0.001|TWO_SIDED|95.0|11.6|25.7|||Miettinen and Nurminen|||||25.7|11.6|< 0.001
71070378|NCT02738879|141649719|SUPERIORITY||Between Group Difference in the LSM|-6.5|||=|0.02|TWO_SIDED|95.0|-11.9|-1.0|||LDA|||Analysis was based on a LDA model including terms for treatment, AHA treatment at screening (Met + DPP-4i, Met + DPP-4i + SU, Met + SU), time, and the interactions of time by treatment and of time by AHA treatment at screening.||-1.0|-11.9|= 0.020
71070379|NCT02738879|141649720|OTHER|95% CI|Between Group Difference in Percentages|-2.1|||||TWO_SIDED|95.0|-9.1|5.0|||Miettinen & Nurminen|||||5.0|-9.1|
71070380|NCT02738879|141649721|SUPERIORITY||Event Rate Ratio|0.76|||=|0.394|TWO_SIDED|95.0|0.4|1.44|||Negative Binomial Model|||The analysis was calculated via the Negative Binomial Model including terms for treatment, race (i.e., White and Other), region (i.e., Europe, North America, and Other), AHA treatment at screening, baseline A1C value and baseline body weight and an offset for follow-up time (on the natural log scale).||1.44|0.40|= 0.394
71070381|NCT02738879|141649722|SUPERIORITY||Between Group Difference in Percentages|-1.2|||=|0.74|TWO_SIDED|95.0|-8.2|5.8|||Miettinen and Nurminen|||The analysis included imputed events after participants discontinued from the study medication, using a Gamma frailty model. Proportions and difference in proportions were calculated via the Miettinen and Nurminen stratified by AHA treatment at screening. The bootstrap method was used to obtain the CI and p-value.||5.8|-8.2|= 0.740
71070382|NCT02738879|141649723|SUPERIORITY||Between Group Difference in Percentages|-0.7|||=|0.712|TWO_SIDED|95.0|-4.7|3.2|||Miettinen and Nurminen|||Percentages and difference in percentages were calculated via the Miettinen and Nurminen stratified by AHA treatment at screening. The analysis included imputed events after subjects discontinued from the study medication, using a Gamma frailty model. The bootstrap method was used to obtain the CI and p-value.||3.2|-4.7|= 0.712
71113471|NCT03745638|141734731|SUPERIORITY||Odds Ratio (OR)|5.22|||<|0.0001|TWO_SIDED|95.0|3.145|8.831||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||8.831|3.145|< 0.0001
70939031|NCT00896389|141378773|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.||||>0.05
71070383|NCT02738879|141649724|SUPERIORITY||Between Group Difference in Percentages|5.3|||=|0.03|TWO_SIDED|95.0|0.5|10.1|||Miettinen and Nurminen|||||10.1|0.5|= 0.030
71070384|NCT01730534|141649750|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.172||95.0|0.84|1.03|||Regression, Cox|||||1.03|0.84|0.172
71070385|NCT01730534|141649751|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.005||95.0|0.73|0.95|||Regression, Cox|||||0.95|0.73|0.005
71070386|NCT01730534|141649752|SUPERIORITY||Hazard Ratio (HR)|0.76|||<|0.001||95.0|0.67|0.87|||Regression, Cox|||||0.87|0.67|<0.001
71070387|NCT01730534|141649753|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.198||95.0|0.82|1.04|||Regression, Cox|||||1.04|0.82|0.198
71070388|NCT03369067|141649785|OTHER|||||||0.01||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.010
71070389|NCT03369067|141649785|OTHER|||||||0.089||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.089
71070390|NCT03369067|141649785|OTHER|||||||0.024||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.024
71029103|NCT00891293|141565718|SUPERIORITY_OR_OTHER||Median Difference (Net)|3.3|STANDARD_DEVIATION|29.01||0.9999||95.0|-2.8|9.4|||ANOVA||Difference Between Percent Change from LOV111859/OM5 Baseline to LOV111860/OM5X End-of-Treatment and Percent Change from LOV111859/OM5 Baseline to LOV111821/OM5XX End-of-Treatment|For the MITT analysis, the method of last observation carried forward (LOCF) was applied. The LOCF is the value of a previous non-baseline visit (post-enrollment) carried forward to the subsequent visit, if missing.||9.4|-2.8|0.9999
71070391|NCT03369067|141649786|OTHER|||||||0.095||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.095
71070392|NCT03369067|141649786|OTHER|||||||0.104||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.104
71070393|NCT03369067|141649786|OTHER|||||||0.042||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.042
71070394|NCT03369067|141649787|OTHER||||||<|0.001||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||<0.001
71070395|NCT03369067|141649787|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
70852842|NCT03456882|141194475|SUPERIORITY||difference between mean slopes|-0.12|STANDARD_ERROR_OF_MEAN|0.1||0.1556|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|ALSAQ-40 ADL and independence.Contrast of the slopes during the on-treatment and off-treatment follow-up period (change per week, from baseline to week 48) between treatment groups. Null hypothesis: the rate of change from baseline to week 48 is not different between groups.||||0.1556
70852843|NCT03456882|141194475|SUPERIORITY||difference between mean slopes|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.0319|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|ALSAQ-40 eating and drinking. Contrast of the slopes during the on-treatment and off-treatment follow-up period (change per week, from baseline to week 48) between treatment groups. Null hypothesis: the rate of change from baseline to week 48 is not different between groups.||||0.0319
70852844|NCT03456882|141194475|SUPERIORITY||difference between mean slopes|-0.04|STANDARD_ERROR_OF_MEAN|0.1||0.6419|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|ALSAQ-40 communication. Contrast of the slopes during the on-treatment and off-treatment follow-up period (change per week, from baseline to week 48) between treatment groups. Null hypothesis: the rate of change from baseline to week 48 is not different between groups.||||0.6419
70852845|NCT03456882|141194475|SUPERIORITY||difference between mean slopes|0.07|STANDARD_ERROR_OF_MEAN|0.1||0.3951|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|ALSAQ-40 emotional reactions. Contrast of the slopes during the on-treatment and off-treatment follow-up period (change per week, from baseline to week 48) between treatment groups. Null hypothesis: the rate of change from baseline to week 48 is not different between groups.||||0.3951
70852846|NCT03456882|141194476|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|3.8||0.9563|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.9563
71029104|NCT00159965|141565730|SUPERIORITY_OR_OTHER||Risk Ratio, log|0.673|STANDARD_ERROR_OF_MEAN|0.369||0.29|TWO_SIDED|95.0|-0.051|1.396|||Overdispersed Poisson Regression|||Between-group seizure change. The primary hypothesis of this pilot randomized control trial (RCT) was to assess the magnitude of seizure frequency reduction by treatment, comparing placbo to sertraline. The alternative hypothesis is that patients treated with sertraline will show a significant decrease in seizures from baseline to exit.||1.396|-0.051|0.29
71029105|NCT00159965|141565730|SUPERIORITY_OR_OTHER||Risk Ratio, log|-0.598|STANDARD_ERROR_OF_MEAN|0.276||0.03|TWO_SIDED|95.0|-1.139|-0.073|||Overdispersed Poisson Regression|||Within-group seizure change. The hypothesis is that patients treated with sertraline will show a significant decrease in seizures from baseline to exit.||-0.073|-1.139|0.03
71029106|NCT00159965|141565730|SUPERIORITY_OR_OTHER||Risk Ratio, log|0.077|STANDARD_ERROR_OF_MEAN|0.252||0.78|TWO_SIDED|95.0|-0.431|0.571|||Overdispersed Poisson Regression|||Within-group seizure change. The hypothesis is that patients treated with placebo will not show a significant decrease in seizures from baseline to exit.||0.571|-0.431|0.78
71029107|NCT00159965|141565731|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71029108|NCT00159965|141565732|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71029109|NCT00159965|141565733|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71029110|NCT00159965|141565734|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71029111|NCT00159965|141565735|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71029112|NCT00159965|141565736|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71029113|NCT00159965|141565737|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71029114|NCT00159965|141565738|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71029115|NCT00159965|141565739|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71029116|NCT00159965|141565740|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71029117|NCT00159965|141565741|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71029118|NCT00159965|141565742|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71029119|NCT00159965|141565743|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71070396|NCT03369067|141649787|OTHER|||||||0.065||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.065
71070397|NCT03369067|141649788|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070398|NCT03369067|141649788|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070399|NCT03369067|141649788|OTHER|||||||0.063||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.063
71070400|NCT03369067|141649789|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070401|NCT03369067|141649789|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070402|NCT03369067|141649789|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070403|NCT03369067|141649790|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070404|NCT03369067|141649790|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070405|NCT03369067|141649790|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070406|NCT03369067|141649791|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070407|NCT03369067|141649791|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070408|NCT03369067|141649791|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070409|NCT03369067|141649792|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070410|NCT03369067|141649792|OTHER|||||||0.062||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.062
71070411|NCT03369067|141649792|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070412|NCT03369067|141649793|OTHER|||||||0.015||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.015
71070413|NCT03369067|141649793|OTHER|||||||0.199||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.199
71070414|NCT03369067|141649793|OTHER|||||||0.025||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.025
71070415|NCT03369067|141649794|OTHER|||||||0.059||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.059
71070416|NCT03369067|141649794|OTHER|||||||0.064||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.064
71070417|NCT03369067|141649794|OTHER|||||||0.017||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.017
71070418|NCT03369067|141649795|OTHER|||||||0.034||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.034
71070419|NCT03369067|141649795|OTHER|||||||0.074||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.074
71070420|NCT03369067|141649795|OTHER|||||||0.034||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.034
71070421|NCT03369067|141649796|OTHER|||||||0.023||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.023
71070422|NCT03369067|141649796|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070423|NCT03369067|141649796|OTHER|||||||0.016||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.016
70939032|NCT00896389|141378774|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05|||||||Chi-squared|Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.||||>0.05
70939033|NCT00379210|141378787|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANOVA|||Statistical tests are evaluated at an alpha level of 0.05 (corrected, when appropriate, for multiple comparisons). Analyses are performed on both response latency and accuracy on behavioral data. For latency analyses, mean response times for correct trials are calculated for each subject. Repeated-measures ANOVA are used for omnibus tests; paired t-tests are used for individual planned contrasts, with Bonferroni-corrected significance levels to maintain a .05 alpha level||||<0.01
70939034|NCT01358175|141378800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.76|||<|0.0001|TWO_SIDED|95.0|2.2|6.42|||Regression, Logistic|||||6.42|2.20|<0.0001
70939035|NCT01358175|141378800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.89|||<|0.0001|TWO_SIDED|95.0|2.28|6.65|||Regression, Logistic|||||6.65|2.28|<0.0001
70939036|NCT05072795|141378808|OTHER|||||||0.005|||||||t-test, 2 sided|||||||0.005
70939037|NCT01107912|141378814|NON_INFERIORITY_OR_EQUIVALENCE|The difference of median MPA to 20 μM ADP of a prasugrel 5-mg in the elderly group to the 75th percentile of the MPA to 20 μM ADP of a prasugrel 10 mg MD in the non-elderly group at the end of Period 1 was estimated from the observed data. The upper limit of the one-sided 97.5% confidence interval for the difference was estimated from resampling data with replacement through bootstrap methodology and was used to compare with the non-inferiority margin of 15 percentage points.|Estimate of the difference|6.0|||||TWO_SIDED|95.0|1.0|9.0||||||||9.00|1.00|
70939038|NCT01601821|141378819|SUPERIORITY_OR_OTHER||percent difference|-2.0||||0.341|TWO_SIDED|90.0|-5.5|1.5|||Chi-squared|||Chi-square test was used to test superiority of arm CsA+Rapamune+CS versus arm CsA+MMF+CS.||1.5|-5.5|0.341
70939039|NCT01601821|141378820|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 3: One-way analysis of variance (ANOVA) was used to test the difference.||||0.870
70939040|NCT01601821|141378820|SUPERIORITY_OR_OTHER|||||||0.381|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 6: One-way ANOVA was used to test the difference.||||0.381
70939041|NCT01601821|141378820|SUPERIORITY_OR_OTHER|||||||0.096|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 12: One-way ANOVA was used to test the difference.||||0.096
70939042|NCT01601821|141378821|SUPERIORITY_OR_OTHER|||||||0.979|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 3: One-way ANOVA was used to test the difference.||||0.979
70939043|NCT01601821|141378821|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 6: One-way ANOVA was used to test the difference.||||0.660
70939044|NCT01601821|141378821|SUPERIORITY_OR_OTHER|||||||0.518|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 12: One-way ANOVA was used to test the difference.||||0.518
70939045|NCT01601821|141378822|SUPERIORITY_OR_OTHER|||||||0.786|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 3: One-way ANOVA was used to test the difference.||||0.786
70939046|NCT01601821|141378822|SUPERIORITY_OR_OTHER|||||||0.738|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 6: One-way ANOVA was used to test the difference.||||0.738
70939047|NCT01601821|141378822|SUPERIORITY_OR_OTHER|||||||0.977|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 12: One-way ANOVA was used to test the difference.||||0.977
70939048|NCT01601821|141378823|SUPERIORITY_OR_OTHER|||||||0.999|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Fisher Exact|||Fisher's exact test was used to test the difference.||||0.999
70939049|NCT01601821|141378825|SUPERIORITY_OR_OTHER|||||||0.276|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Fisher Exact|||Fisher's exact test was used to test the difference.||||0.276
70939050|NCT01601821|141378826|SUPERIORITY_OR_OTHER|||||||0.999|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Fisher Exact|||Fisher's exact test was used to test the difference.||||0.999
70939051|NCT01601821|141378827|SUPERIORITY_OR_OTHER|||||||0.868|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Chi-squared|||Chi-square test was used to test the difference.||||0.868
70939052|NCT01601821|141378828|SUPERIORITY_OR_OTHER|||||||0.999|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Fisher Exact|||Fisher's exact test was used to test the difference.||||0.999
70939053|NCT01601821|141378829|SUPERIORITY_OR_OTHER|||||||0.985|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Chi-squared|||Chi-square test was used to test the difference.||||0.985
70939054|NCT01601821|141378830|SUPERIORITY_OR_OTHER|||||||0.172|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Fisher Exact|||Fisher's exact test was used to test the difference.||||0.172
70939055|NCT01601821|141378831|SUPERIORITY_OR_OTHER|||||||0.978|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Chi-squared|||Chi-square test was used to test the difference.||||0.978
70939056|NCT00442559|141378854|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16||||0.015|TWO_SIDED|95.0|-0.29|-0.03|||t-test, 2 sided|||Change from BL to Week 12 - Montelukast. The difference in mean change from baseline to 12 weeks in daytime asthma symptom score was tested by paired t-test (H0: difference =0) for the Montelukast treatment group. Subjects in this analysis: N=24 subjects for the within arm (single arm) comparison between BL and Week 12 scores.||-0.03|-0.29|0.015
70939057|NCT00442559|141378854|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16||||0.027|TWO_SIDED|95.0|-0.3|-0.02|||t-test, 2 sided|||Change from BL to Week 12 - ICS. The difference in mean change from baseline to 12 weeks in daytime asthma symptom score was tested by paired t-test (H0: difference =0) for the ICS treatment group. Subjects in this analysis: N=29 subjects for the within arm (single arm) comparison between BL and Week 12 scores.||-0.02|-0.3|0.027
71070424|NCT03369067|141649797|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71113472|NCT03745638|141734732|SUPERIORITY||Odds Ratio (OR)|3.66||||0.0002|TWO_SIDED|95.0|1.773|8.083||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||8.083|1.773|0.0002
71113473|NCT03745638|141734732|SUPERIORITY||Odds Ratio (OR)|6.01|||<|0.0001|TWO_SIDED|95.0|2.931|13.22||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||13.220|2.931|< 0.0001
71113474|NCT03745638|141734733|SUPERIORITY||Odds Ratio (OR)|2.56||||0.0081|TWO_SIDED|95.0|1.242|5.723||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||5.723|1.242|0.0081
70939058|NCT00442559|141378855|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.21||||0.006|TWO_SIDED|95.0|-0.36|-0.07|||t-test, 2 sided|||Change from BL to Week 12 - Montelukast. The difference in mean change from baseline to 12 weeks in daily allergic rhinitis symptom score was tested by paired t-test (H0: difference =0) for the Montelukast treatment group. Subjects in this analysis: N=24 subjects for the within arm (single arm) comparison between BL and Week 12 scores.||-0.07|-0.36|0.006
70939059|NCT00442559|141378855|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12||||0.032|TWO_SIDED|95.0|-0.24|-0.01|||t-test, 2 sided|||Change from BL to Week 12 - ICS. The difference in mean change from baseline to 12 weeks in daily allergic rhinitis symptom score was tested by paired t-test (H0: difference =0) for the ICS treatment group. Subjects in this analysis: N=28 subjects for the within arm (single arm) comparison between BL and Week 12 scores.||-0.01|-0.24|0.032
70939060|NCT00848198|141378880|SUPERIORITY_OR_OTHER||Sensitivity|87.1|||||TWO_SIDED|95.0|83.2|90.9||||||||90.9|83.2|
71113475|NCT03745638|141734733|SUPERIORITY||Odds Ratio (OR)|2.74||||0.0039|TWO_SIDED|95.0|1.334|6.083||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||6.083|1.334|0.0039
71113476|NCT03745638|141734734|SUPERIORITY||Odds Ratio (OR)|1.67||||0.1421|TWO_SIDED|95.0|0.862|3.391||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||3.391|0.862|0.1421
71113477|NCT03745638|141734734|SUPERIORITY||Odds Ratio (OR)|1.82||||0.0746|TWO_SIDED|95.0|0.949|3.665||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||3.665|0.949|0.0746
71113478|NCT03745638|141734744|SUPERIORITY||Least Squares Mean Difference|-35.48|STANDARD_ERROR_OF_MEAN|4.16|<|0.0001|TWO_SIDED|95.0|-43.64|-27.32|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 2||-27.32|-43.64|< 0.0001
71113479|NCT03745638|141734744|SUPERIORITY||Least Squares Method of Mean Difference]|-40.29|STANDARD_ERROR_OF_MEAN|4.15|<|0.0001|TWO_SIDED|95.0|-48.44|-32.13|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 2||-32.13|-48.44|< 0.0001
71113480|NCT03745638|141734744|SUPERIORITY||Least Squares Mean Difference|-45.01|STANDARD_ERROR_OF_MEAN|4.72|<|0.0001|TWO_SIDED|95.0|-54.28|-35.74|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 4||-35.74|-54.28|< 0.0001
71113481|NCT03745638|141734744|SUPERIORITY||Least Squares Mean Difference|-48.05|STANDARD_ERROR_OF_MEAN|4.71|<|0.0001|TWO_SIDED|95.0|-57.3|-38.79|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 4||-38.79|-57.30|< 0.0001
71113482|NCT03745638|141734744|SUPERIORITY||Least Squares Mean Difference|-33.13|STANDARD_ERROR_OF_MEAN|4.49|<|0.0001|TWO_SIDED|95.0|-41.95|-24.3||The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.|Mixed-Model with Repeated Measures|||Percent change from Baseline in EASI score at Week 8||-24.30|-41.95|< 0.0001
70939061|NCT00848198|141378880|SUPERIORITY_OR_OTHER||Specificity|72.0|||||TWO_SIDED|95.0|66.9|77.1||||||||77.1|66.9|
71113483|NCT03745638|141734744|SUPERIORITY||Least Squares Mean Difference|-39.52|STANDARD_ERROR_OF_MEAN|4.48|<|0.0001|TWO_SIDED|95.0|-48.32|-30.72|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 8||-30.72|-48.32|< 0.0001
71113484|NCT03745638|141734745|SUPERIORITY||Least Squares Mean Difference|-25.3|STANDARD_ERROR_OF_MEAN|3.74|<|0.0001|TWO_SIDED|95.0|-32.62|-17.95|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent change from Baseline in SCORAD score at Week 8||-17.95|-32.62|< 0.0001
71113485|NCT03745638|141734745|SUPERIORITY||Least Squares Mean Difference|-30.4|STANDARD_ERROR_OF_MEAN|3.72|<|0.0001|TWO_SIDED|95.0|-37.68|-23.06|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent change from Baseline in SCORAD score at Week 8||-23.06|-37.68|< 0.0001
70939062|NCT00848198|141378881|SUPERIORITY_OR_OTHER||Sensitivity|39.7|||||TWO_SIDED|95.0|34.2|45.3||||||||45.3|34.2|
70939063|NCT00848198|141378881|SUPERIORITY_OR_OTHER||Specificity|82.7|||||TWO_SIDED|95.0|78.4|87.0||||||||87.0|78.4|
70939064|NCT00848198|141378882|SUPERIORITY_OR_OTHER||Sensitivity|71.9|||||TWO_SIDED|95.0|66.8|77.0||||||||77.0|66.8|
70939065|NCT00848198|141378882|SUPERIORITY_OR_OTHER||Specificity|82.7|||||TWO_SIDED|95.0|78.4|87.0||||||||87.0|78.4|
70939066|NCT00848198|141378883|SUPERIORITY_OR_OTHER||Sensitivity|27.2|||||TWO_SIDED|95.0|22.2|32.3||||||||32.3|22.2|
70939067|NCT00848198|141378883|SUPERIORITY_OR_OTHER||Specificity|98.7|||||TWO_SIDED|95.0|97.4|100.0||||||||100.0|97.4|
71113486|NCT03745638|141734746|SUPERIORITY||Least Squares Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.87|-0.91|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 2||-0.91|-1.87|<0.0001
71113487|NCT03745638|141734746|SUPERIORITY||Least Squares Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-2.11|-1.16|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 2||-1.16|-2.11|<0.0001
71113488|NCT03745638|141734746|SUPERIORITY||Least Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.25|-1.15|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 4||-1.15|-2.25|<0.0001
71113489|NCT03745638|141734746|SUPERIORITY||Least Squares Mean Difference|-2.08|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.63|-1.53|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 4||-1.53|-2.63|<0.0001
71113490|NCT03745638|141734746|SUPERIORITY||Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.2|-1.01|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 8||-1.01|-2.20|<0.0001
71113491|NCT03745638|141734746|SUPERIORITY||Least Squares Mean Difference|-1.99|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.58|-1.4|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 8||-1.40|-2.58|<0.0001
71113492|NCT03745638|141734748|SUPERIORITY||Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.74|-0.74|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in Skin Pain NRS score at Week 8||-0.74|-1.74|<0.0001
71113493|NCT03745638|141734748|SUPERIORITY||Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-2.11|-1.13|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in Skin Pain NRS score at Week 8||-1.13|-2.11|<0.0001
71113494|NCT03745638|141734751|SUPERIORITY||Least Squares Mean Difference|-1.53|STANDARD_ERROR_OF_MEAN|0.54||0.0049|TWO_SIDED|95.0|-2.6|-0.47|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 2||-0.47|-2.60|0.0049
71113495|NCT03745638|141734751|SUPERIORITY||Least Squares Mean Difference|-2.31|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-3.37|-1.25|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 2||-1.25|-3.37|<0.0001
71113496|NCT03745638|141734751|SUPERIORITY||Least Squares Mean Difference|-2.33|STANDARD_ERROR_OF_MEAN|0.6||0.0001|TWO_SIDED|95.0|-3.52|-1.15|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 4||-1.15|-3.52|0.0001
71113497|NCT03745638|141734751|SUPERIORITY||Least Squares Mean Difference|-2.85|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|-4.03|-1.67|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 4||-1.67|-4.03|<0.0001
71113498|NCT03745638|141734751|SUPERIORITY||Least Squares Mean Difference|-2.54|STANDARD_ERROR_OF_MEAN|0.71||0.0004|TWO_SIDED|95.0|-3.93|-1.14|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 8||-1.14|-3.93|0.0004
71113499|NCT03745638|141734751|SUPERIORITY||Least Squares Mean Difference|-3.18|STANDARD_ERROR_OF_MEAN|0.71|<|0.0001|TWO_SIDED|95.0|-4.57|-1.79|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 8||-1.79|-4.57|<0.0001
71113500|NCT03745638|141734752|SUPERIORITY||Least Squares Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.6||0.0487|TWO_SIDED|95.0|-2.35|-0.01|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 2||-0.01|-2.35|0.0487
70852847|NCT03456882|141194477|SUPERIORITY||Mean Difference (Net)|28.5|STANDARD_ERROR_OF_MEAN|23.4||0.2253|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.2253
70852848|NCT03456882|141194478|SUPERIORITY||Mean Difference (Net)|-7.7|STANDARD_ERROR_OF_MEAN|15.7||0.6263|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.6263
70852849|NCT03456882|141194479|SUPERIORITY||Mean Difference (Final Values)|-19.0|STANDARD_ERROR_OF_MEAN|21.0||0.3671|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.3671
70939068|NCT00848198|141378884|SUPERIORITY_OR_OTHER||Sensitivity|51.3|||||TWO_SIDED|95.0|45.7|57.0||||||||57.0|45.7|
70939069|NCT00848198|141378884|SUPERIORITY_OR_OTHER||Specificity|94.7|||||TWO_SIDED|95.0|92.1|97.2||||||||97.2|92.1|
70939070|NCT00848198|141378885|SUPERIORITY_OR_OTHER||Sensitivity|61.2|||||TWO_SIDED|95.0|55.6|66.7||||||||66.7|55.6|
71113501|NCT03745638|141734752|SUPERIORITY||Least Squares Mean Difference|-1.68|STANDARD_ERROR_OF_MEAN|0.59||0.0049|TWO_SIDED|95.0|-2.84|-0.51|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 2||-0.51|-2.84|0.0049
71113502|NCT03745638|141734752|SUPERIORITY||Least Squares Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.66||0.0128|TWO_SIDED|95.0|-2.94|-0.35|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 4||-0.35|-2.94|0.0128
70939071|NCT00848198|141378885|SUPERIORITY_OR_OTHER||Specificity|78.7|||||TWO_SIDED|95.0|74.0|83.3||||||||83.3|74.0|
71113503|NCT03745638|141734752|SUPERIORITY||Least Squares Mean Difference|-1.91|STANDARD_ERROR_OF_MEAN|0.66||0.0037|TWO_SIDED|95.0|-3.2|-0.62|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 4||-0.62|-3.20|0.0037
71113504|NCT03745638|141734752|SUPERIORITY||Least Squares Mean Difference|-2.11|STANDARD_ERROR_OF_MEAN|0.75||0.0048|TWO_SIDED|95.0|-3.58|-0.65|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 8||-0.65|-3.58|0.0048
71113505|NCT03745638|141734752|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.74||0.002|TWO_SIDED|95.0|-3.75|-0.84|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 8||-0.84|-3.75|0.0020
71113506|NCT03745638|141734755|SUPERIORITY||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-4.07|-2.18|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in %BSA at Week 8||-2.18|-4.07|<0.0001
71113507|NCT03745638|141734755|SUPERIORITY||Least Squares Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-4.67|-2.79|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in %BSA at Week 8||-2.79|-4.67|<0.0001
71113508|NCT03745638|141734757|SUPERIORITY||Least Squares Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-6.43|-3.8|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in POEM score at Week 8||-3.80|-6.43|<0.0001
71113509|NCT03745638|141734757|SUPERIORITY||Least Squares Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-7.62|-5.0|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in POEM score at Week 8||-5.00|-7.62|<0.0001
71113510|NCT03745638|141734759|SUPERIORITY||Least Squares Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|-4.85|-2.68|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total DLQI score at Week 8||-2.68|-4.85|<0.0001
71113511|NCT03745638|141734759|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|-5.56|-3.42|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total DLQI score at Week 8||-3.42|-5.56|<0.0001
71113512|NCT03745638|141734761|SUPERIORITY||Least Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|1.01||0.0018|TWO_SIDED|95.0|-5.29|-1.26|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total CDLQI score at Week 8||-1.26|-5.29|0.0018
70939072|NCT00848198|141378886|SUPERIORITY_OR_OTHER||Sensitivity|58.5|||||TWO_SIDED|95.0|52.9|64.1||||||||64.1|52.9|
70939073|NCT00848198|141378886|SUPERIORITY_OR_OTHER||Specificity|73.3|||||TWO_SIDED|95.0|68.3|78.3||||||||78.3|68.3|
70941932|NCT03866434|141384011|EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%.|% ratio of Geometric LS means|86.504|||||TWO_SIDED|90.0|78.462|95.371|||ANOVA|A 2-factor analysis of variance (ANOVA) model with fixed factors for treatment and participant was fitted to the natural logtransformed PK parameters.|This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole \[Day 8\] versus anagrelide alone \[Day 1\]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the LS mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CI were calculated.||95.371|78.462|
71113513|NCT03745638|141734761|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.08||0.0378|TWO_SIDED|95.0|-4.43|-0.13|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total CDLQI score at Week 8||-0.13|-4.43|0.0378
71113514|NCT03745638|141734765|SUPERIORITY||Odds Ratio (OR)|6.28|||<|0.0001|TWO_SIDED|95.0|3.632|11.018||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||Percentage of participants with a score of either 1 or 2 on the PGIC at Week 8||11.018|3.632|<0.0001
71113515|NCT03745638|141734765|SUPERIORITY||Odds Ratio (OR)|8.39|||<|0.0001|TWO_SIDED|95.0|4.755|15.083||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||Percentage of participants with a score of either 1 or 2 on the PGIC at Week 8||15.083|4.755|<0.0001
71113516|NCT03745638|141734766|SUPERIORITY||Least Squares Mean Difference|4.9|STANDARD_ERROR_OF_MEAN|1.67||0.0037|TWO_SIDED|95.0|1.59|8.15|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in EQ VAS score at Week 8||8.15|1.59|0.0037
71113517|NCT03745638|141734766|SUPERIORITY||Least Squares Mean Difference|5.7|STANDARD_ERROR_OF_MEAN|1.66||0.0006|TWO_SIDED|95.0|2.45|8.96|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in EQ VAS score at Week 8||8.96|2.45|0.0006
70941933|NCT00385697|141384022|SUPERIORITY||Odds Ratio (OR)|0.963||||0.904|TWO_SIDED|95.0|0.521|1.779|||Mantel Haenszel|||||1.779|0.521|0.904
70941934|NCT00385697|141384022|SUPERIORITY||Odds Ratio (OR)|0.629||||0.222|TWO_SIDED|95.0|0.297|1.33|||Mantel Haenszel|||||1.330|0.297|0.222
71113518|NCT03745638|141734767|SUPERIORITY||Least Squares Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|3.34||0.1417|TWO_SIDED|95.0|-11.49|1.65|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent work time missed due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||1.65|-11.49|0.1417
71113519|NCT03745638|141734767|SUPERIORITY||Least Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|3.29||0.6037|TWO_SIDED|95.0|-8.19|4.77|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent work time missed due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||4.77|-8.19|0.6037
71113520|NCT03745638|141734767|SUPERIORITY||Least Squares Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|2.99||0.0003|TWO_SIDED|95.0|-16.89|-5.12|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent impairment while working due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-5.12|-16.89|0.0003
71113521|NCT03745638|141734767|SUPERIORITY||Least Squares Mean Difference|-12.2|STANDARD_ERROR_OF_MEAN|2.93|<|0.0001|TWO_SIDED|95.0|-17.98|-6.47|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent impairment while working due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-6.47|-17.98|<0.0001
71113522|NCT03745638|141734767|SUPERIORITY||Least Squares Mean Difference|-15.4|STANDARD_ERROR_OF_MEAN|3.85|<|0.0001|TWO_SIDED|95.0|-22.95|-7.81|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent overall work impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-7.81|-22.95|<0.0001
71113523|NCT03745638|141734767|SUPERIORITY||Least Squares Mean Difference|-12.4|STANDARD_ERROR_OF_MEAN|3.77||0.0011|TWO_SIDED|95.0|-19.85|-5.01|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent overall work impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-5.01|-19.85|0.0011
70941935|NCT00385697|141384022|SUPERIORITY||Odds Ratio (OR)|1.054||||0.885|TWO_SIDED|95.0|0.521|2.129|||Mantel Haenszel|||||2.129|0.521|0.885
71113524|NCT03745638|141734767|SUPERIORITY||Least Squares Mean Difference|-10.5|STANDARD_ERROR_OF_MEAN|2.13|<|0.0001|TWO_SIDED|95.0|-14.64|-6.29|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent activity impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-6.29|-14.64|<0.0001
71113525|NCT03745638|141734767|SUPERIORITY||Least Squares Mean Difference|-12.4|STANDARD_ERROR_OF_MEAN|2.12|<|0.0001|TWO_SIDED|95.0|-16.6|-8.29|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent activity impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-8.29|-16.60|<0.0001
71113526|NCT01032603|141734771|SUPERIORITY||Difference in percentage of participants|9.0||||0.24|TWO_SIDED|95.0|-6.0|23.0|||Z test||Proportion of participants meeting criteria was obtained by Kaplan-Meier method. BLR group=46%, RR group=37%. Probability was compared b/w groups using Z test. A group difference and 95% CI were calculated. Positive differences favor the RR group.|||23|-6|0.24
71113527|NCT01032603|141734772|SUPERIORITY||Difference in percentage of participants|8.0||||0.25|TWO_SIDED|95.0|-6.0|21.0|||Z test||Proportion of participants meeting criteria was obtained by Kaplan-Meier method. BLR group=34%, RR group=26%. Probability was compared b/w groups using Z test. A group difference and 95% CI were calculated. Positive differences favor the RR group.|||21|-6|0.25
71113528|NCT01032603|141734773|SUPERIORITY||Difference in percentage of participants|-7.0||||0.06|TWO_SIDED|95.0|-14.0|0.23|||Z test||Proportion of participants meeting criteria was obtained by Kaplan-Meier method. BLR group=3%, RR group=10%. Probability was compared b/w groups using Z test. A group difference and 95% CI were calculated. Positive differences favor the RR group.|||0.23|-14|0.06
71113529|NCT01032603|141734774|SUPERIORITY||Difference in percentage of participants|4.0||||0.36|TWO_SIDED|95.0|-5.0|14.0|||Z test||Proportion of participants meeting criteria by 3 yrs was obtained by KM method. BLR group=14%, RR group=10%. Probability was compared b/w groups using Z test. A group difference and 95% CI were calculated. Positive differences favor the RR group.|||14|-5|0.36
70941936|NCT00385697|141384024|SUPERIORITY||Mean Difference (Final Values)|0.061||||0.814|TWO_SIDED|95.0|-0.45|0.572|||ANCOVA|||||0.572|-0.450|0.814
70941937|NCT00385697|141384024|SUPERIORITY||Mean Difference (Final Values)|0.161||||0.593|TWO_SIDED|95.0|-0.433|0.755|||ANCOVA|||||0.755|-0.433|0.593
70941938|NCT00385697|141384024|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.886|TWO_SIDED|95.0|-0.594|0.513|||ANCOVA|||||0.513|-0.594|0.886
71070425|NCT03369067|141649797|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070426|NCT03369067|141649797|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
70941939|NCT00385697|141384026|SUPERIORITY||Mean Difference (Final Values)|0.047||||0.049|TWO_SIDED|95.0|0.0|0.093|||ANCOVA|||||0.093|0.000|0.049
71070427|NCT03369067|141649798|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070428|NCT03369067|141649798|OTHER|||||||0.081||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.081
71070429|NCT03369067|141649798|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070430|NCT03369067|141649799|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070431|NCT03369067|141649799|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070432|NCT03369067|141649799|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070433|NCT03369067|141649800|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070434|NCT03369067|141649800|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71113530|NCT01032603|141734776|SUPERIORITY|||||||0.44|||||||ANOVA|||3-year control outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value (e.g. ANCOVA model of 3-year distance control will adjust for baseline distance control).||||0.44
71070435|NCT03369067|141649800|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070436|NCT03369067|141649801|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71113531|NCT01032603|141734779|SUPERIORITY|||||||0.64|||||||ANOVA|||3-year control outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value (e.g. ANCOVA model of 3-year near control will adjust for baseline near control).||||0.64
71070437|NCT03369067|141649801|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71113532|NCT01032603|141734782|SUPERIORITY|||||||0.21|||||||ANOVA|||3-year PACT outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value.||||0.21
71113533|NCT01032603|141734785|SUPERIORITY|||||||0.38|||||||ANOVA|||3-year PACT outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value.||||0.38
71113534|NCT01032603|141734788|SUPERIORITY|||||||0.93|||||||ANOVA|||3-year stereoacuity outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value.||||0.93
71113535|NCT01032603|141734791|SUPERIORITY|||||||0.82|||||||ANOVA|||3-year stereoacuity outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value.||||0.82
71070438|NCT03369067|141649801|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070439|NCT03369067|141649802|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070440|NCT03369067|141649802|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070441|NCT03369067|141649802|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070442|NCT03369067|141649803|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070443|NCT03369067|141649803|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71113536|NCT01032603|141734793|SUPERIORITY|||||||0.3||||||Child 5 to 7 years old|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores at 3 years were compared between treatment groups using the Wilcoxon rank sum test.||||0.30
71070444|NCT03369067|141649803|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070445|NCT03369067|141649804|OTHER|||||||0.124||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.124
71070446|NCT03369067|141649804|OTHER|||||||0.187||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.187
71070447|NCT03369067|141649804|OTHER|||||||0.04||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.040
71070448|NCT03369067|141649805|OTHER|||||||0.108||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.108
71070449|NCT03369067|141649805|OTHER|||||||0.053||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.053
71113537|NCT01032603|141734793|SUPERIORITY|||||||0.77||||||Child 8 to 13 years old|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores9, 10 at 3 years were compared between treatment groups using the Wilcoxon rank sum test.||||0.77
71113538|NCT01032603|141734793|SUPERIORITY|||||||0.51||||||Parent Proxy IXTQ|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores9, 10 at 3 years were compared between treatment groups using the Wilcoxon rank sum test.||||0.51
70941940|NCT00385697|141384026|SUPERIORITY||Mean Difference (Final Values)|-0.002||||0.937|TWO_SIDED|95.0|-0.061|0.056|||ANCOVA|||||0.056|-0.061|0.937
71070450|NCT03369067|141649805|OTHER|||||||0.01||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.010
70941941|NCT00385697|141384026|SUPERIORITY||Mean Difference (Final Values)|0.026||||0.382|TWO_SIDED|95.0|-0.032|0.084|||ANCOVA|||||0.084|-0.032|0.382
71070451|NCT03369067|141649806|OTHER|||||||0.08||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.080
71113539|NCT01032603|141734793|SUPERIORITY|||||||0.42||||||Parent Psychosocial|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores9, 10 at 3 years were compared between treatment groups using the Wilcoxon rank sum test.||||0.42
71113540|NCT01032603|141734793|SUPERIORITY|||||||0.68||||||Parent Function|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores9, 10 at 3 years were compared between treatment groups using the Wilcoxon rank sum test.||||0.68
71113541|NCT01032603|141734793|SUPERIORITY|||||||0.64||||||Parent Surgical|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores9, 10 at 3 years were compared between treatment groups using the Wilcoxon rank sum test.||||0.64
71113542|NCT01032603|141734794|SUPERIORITY||Difference in percentage|5.0|||||TWO_SIDED|95.0|-2.0|13.0||||||"The cumulative proportion of participants with re-operation by 3 years was obtained using the Kaplan-Meier (K-M) method.~A treatment-group difference and a corresponding 95% confidence interval were calculated.~Treatment-group differences were calculated as BLR minus RR."||13|-2|
71113543|NCT01032603|141734795|SUPERIORITY||Difference in percentage of participants|-15.0|||||TWO_SIDED|95.0|-30.0|-0.0003||||||All treatment-group differences were calculated as the BLRc group minus the R\&R group. A treatment-group difference and a corresponding 95% confidence interval were calculated.||-.0003|-30|
71113544|NCT01032603|141734796|SUPERIORITY||Difference in percentage of participants|12.0|||||TWO_SIDED|95.0|-1.0|25.0||||||The proportion of participants with suboptimal surgical outcome at 3 years was compared between treatment groups using Barnard's exact test, and an exact 95% CI on the treatment-group difference was calculated using Farrington-Manning scores.||25|-1|
70941942|NCT00385697|141384028|SUPERIORITY||Odds Ratio (OR)|0.881||||0.775|TWO_SIDED|95.0|0.372|2.089|||Mantel Haenszel|||||2.089|0.372|0.775
70941943|NCT00385697|141384028|SUPERIORITY||Odds Ratio (OR)|0.628||||0.402|TWO_SIDED|95.0|0.212|1.861|||Mantel Haenszel|||||1.861|0.212|0.402
71070452|NCT03369067|141649806|OTHER|||||||0.038||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.038
71070453|NCT03369067|141649806|OTHER|||||||0.016||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.016
71070454|NCT03369067|141649807|OTHER|||||||0.111||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.111
71070455|NCT03369067|141649807|OTHER|||||||0.13||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.130
71070456|NCT03369067|141649807|OTHER|||||||0.017||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.017
71070457|NCT03369067|141649808|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070458|NCT03369067|141649808|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71113545|NCT02168062|141734824|OTHER|||||||0.109|||||||Wilcoxon (Mann-Whitney)|||||||0.109
71113546|NCT02168062|141734826|OTHER|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||Systolic Blood Pressure measurement comparison||||0.85
71113547|NCT02168062|141734826|OTHER|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Diastolic Blood Pressure measurement comparison||||0.10
71113548|NCT02168062|141734827|OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Weight measurement comparison||||0.70
71113549|NCT02168062|141734828|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Percentage body fat measurement comparison||||0.11
71113550|NCT02168062|141734829|OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||Waist measurement comparison||||0.32
71113551|NCT02168062|141734830|OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Hemoglobin A1C measurement comparison||||0.70
71113552|NCT02168062|141734831|OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||Insulin resistance score comparison||||0.46
71113553|NCT02168062|141734832|OTHER|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Total Cholesterol measurement comparison||||0.44
71113554|NCT02168062|141734832|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Total low density lipid measurement comparison||||0.52
71113555|NCT02168062|141734832|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Total high density lipid measurement comparison||||0.40
71113556|NCT02168062|141734832|OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||Total triglyceride measurement comparison||||0.53
71113557|NCT02168062|141734833|OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Non-vigorous physical activity comparison||||0.38
71113558|NCT02168062|141734833|OTHER|||||||0.979|||||||Wilcoxon (Mann-Whitney)|||Moderate physical activity comparison||||0.979
71113559|NCT02168062|141734833|OTHER|||||||0.884|||||||Wilcoxon (Mann-Whitney)|||Moderate-Vigorous physical activity comparison||||0.884
71113560|NCT02168062|141734833|OTHER|||||||0.678|||||||Wilcoxon (Mann-Whitney)|||Vigorous physical activity comparison||||0.678
71113561|NCT02168062|141734833|OTHER|||||||0.464|||||||Wilcoxon (Mann-Whitney)|||Total physical activity comparison||||0.464
71113562|NCT02168062|141734834|OTHER|||||||0.838|||||||Wilcoxon (Mann-Whitney)|||Average MVPA Minutes per Day Comparison||||0.838
71113563|NCT02168062|141734835|OTHER|||||||0.677|||||||Wilcoxon (Mann-Whitney)|||Bone Density at the lumbar spine comparison||||0.677
70941944|NCT00385697|141384028|SUPERIORITY||Odds Ratio (OR)|1.093||||0.859|TWO_SIDED|95.0|0.41|2.912|||Mantel Haenszel|||||2.912|0.410|0.859
71113564|NCT02168062|141734835|OTHER|||||||0.493|||||||Wilcoxon (Mann-Whitney)|||Bone Density at the femoral neck comparison||||0.493
71113565|NCT02168062|141734835|OTHER|||||||0.807|||||||Wilcoxon (Mann-Whitney)|||Bone Density of the total hip comparison||||0.807
71113566|NCT02168062|141734836|OTHER|||||||0.403|||||||Wilcoxon (Mann-Whitney)|||Serum 25-(OH) vitamin D level comparison||||0.403
71113567|NCT02168062|141734837|OTHER|||||||0.385|||||||Wilcoxon (Mann-Whitney)|||||||.385
71113568|NCT02168062|141734838|OTHER|||||||0.148|||||||Wilcoxon (Mann-Whitney)|||Attention Function Index (AFI) Score Comparison||||.148
71113569|NCT02168062|141734839|OTHER|||||||0.077|||||||Wilcoxon (Mann-Whitney)|||Mental Composite Score Comparison||||.077
71113570|NCT02168062|141734839|OTHER|||||||0.401|||||||Wilcoxon (Mann-Whitney)|||Physical Composite Score Comparison||||0.401
71113571|NCT02168062|141734840|OTHER|||||||0.085|||||||Wilcoxon (Mann-Whitney)|||||||0.085
71113572|NCT02168062|141734841|OTHER|||||||0.676|||||||Wilcoxon (Mann-Whitney)|||||||0.676
71113573|NCT02168062|141734842|OTHER|||||||0.183|||||||Wilcoxon (Mann-Whitney)|||||||0.183
71113574|NCT02168062|141734843|OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||EPIC-26 Total Score Comparison||||0.66
71113575|NCT02168062|141734843|OTHER|||||||0.844|||||||Wilcoxon (Mann-Whitney)|||EPIC-26 Urinary Incontinence Score Comparison||||0.844
71113576|NCT02168062|141734843|OTHER|||||||0.175|||||||Wilcoxon (Mann-Whitney)|||EPIC-26 Urinary Irriation Score Comparison||||0.175
71113577|NCT02168062|141734843|OTHER|||||||0.472|||||||Wilcoxon (Mann-Whitney)|||EPIC-26 Bowel Function Score Comparison||||0.472
71113578|NCT02168062|141734843|OTHER|||||||0.405|||||||Wilcoxon (Mann-Whitney)|||EPIC-26 Sexual Function Score Comparison||||0.405
71113579|NCT02168062|141734843|OTHER|||||||0.749|||||||Wilcoxon (Mann-Whitney)|||EPIC-26 Hormonal Function Score Comparison||||0.749
71113580|NCT02168062|141734844|OTHER|||||||0.907|||||||Wilcoxon (Mann-Whitney)|||Fatigue Scale Score Comparison||||0.907
71113581|NCT02168062|141734844|OTHER|||||||0.792|||||||Wilcoxon (Mann-Whitney)|||Energy Scale Score Comparison||||0.792
71113582|NCT01606176|141734868|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.39||||0.332|TWO_SIDED|95.0|-1.18|0.4|||ANCOVA|||"The change was compared between treatment groups using analysis of covariance (ANCOVA). The significance of the treatment effect, after adjusting for baseline pain score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Box Scale-11 Pain Score = Baseline Pain Score + Treatment"||0.40|-1.18|0.332
71113583|NCT01606176|141734869|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-29.55||||0.002|TWO_SIDED|95.0|-48.08|-11.02|||ANOVA|||The proportions were compared between treatment groups using analysis of variance (ANOVA) with treatment as a factor.||-11.02|-48.08|0.002
71113584|NCT01606176|141734870|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.34||||0.052|TWO_SIDED|95.0|-0.68|0.0|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline sleep disturbance score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Sleep Disturbance Score = Baseline Sleep Disturbance Score + Treatment"||0.00|-0.68|0.052
71113585|NCT01606176|141734871|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.79||||0.3|TWO_SIDED|95.0|-8.14|2.56|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Pain Disability Index score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Pain Disability Index Score = Baseline Pain Disability Index Score + Treatment"||2.56|-8.14|0.300
71113586|NCT01606176|141734872|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.66||||0.233|TWO_SIDED|95.0|-4.42|1.1|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Total Brief Pain Inventory (Short Form) score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Total Brief Pain Inventory (Short Form) Score = Baseline Total Brief Pain Inventory (Short Form) Score + Treatment"||1.10|-4.42|0.233
71113587|NCT01606176|141734873|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.28||||0.387|TWO_SIDED|95.0|-0.36|0.91|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Total Spitzer Quality of Life Index score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Total Spitzer Quality of Life Index Score = Baseline Total Spitzer Quality of Life Index Score + Treatment"||0.91|-0.36|0.387
71113588|NCT01606176|141734874|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.47||||1|TWO_SIDED|95.0|-21.56|18.51|||Fisher Exact|||"The proportion of patients who considered their condition Very Much Improved or Much Improved was compared between treatment groups using a Fisher's Exact Test."||18.51|-21.56|1.000
71113589|NCT01606176|141734875|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.86||||0.128|TWO_SIDED|95.0|-1.97|0.26|||ANCOVA|||"The change was compared between treatment groups using analysis of covariance (ANCOVA). The significance of the treatment effect, after adjusting for baseline pain score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Box Scale-11 Pain Score = Baseline Pain Score + Treatment"||0.26|-1.97|0.128
71113590|NCT01606176|141734876|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-31.77||||0.009|TWO_SIDED|95.0|-55.07|-8.47|||ANOVA|||The proportions were compared between treatment groups using ANOVA with treatment as a factor.||-8.47|-55.07|0.009
71113591|NCT01606176|141734877|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.32||||0.184|TWO_SIDED|95.0|-0.8|0.16|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline sleep disturbance score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Sleep Disturbance Score = Baseline Sleep Disturbance Score + Treatment"||0.16|-0.80|0.184
71113592|NCT01606176|141734878|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-5.18||||0.134|TWO_SIDED|95.0|-12.05|1.68|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Pain Disability Index score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Pain Disability Index Score = Baseline Pain Disability Index Score + Treatment"||1.68|-12.05|0.134
71113593|NCT01606176|141734879|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-3.77||||0.031|TWO_SIDED|95.0|-7.17|-0.36|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Total Brief Pain Inventory (Short Form) score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Total Brief Pain Inventory (Short Form) Score = Baseline Total Brief Pain Inventory (Short Form) Score + Treatment"||-0.36|-7.17|0.031
71113594|NCT01606176|141734880|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.04||||0.915|TWO_SIDED|95.0|-0.79|0.88|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Total Spitzer Quality of Life Index score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Total Spitzer Quality of Life Index Score = Baseline Total Spitzer Quality of Life Index Score + Treatment"||0.88|-0.79|0.915
71113595|NCT01606176|141734881|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|3.95||||1|TWO_SIDED|95.0|-21.85|27.47|||Fisher Exact|||"The proportion of patients who considered their condition Very Much Improved or Much Improved was compared between treatment groups using a Fisher's Exact Test."||27.47|-21.85|1.00
71113596|NCT02993822|141734887|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.324|TWO_SIDED|95.0|0.88|1.49|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.49|0.88|0.324
71113597|NCT02993822|141734887|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.332|TWO_SIDED|95.0|0.88|1.48|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.48|0.88|0.332
71113598|NCT02993822|141734887|SUPERIORITY||Mean Difference (Final Values)|0.92||||0.531|TWO_SIDED|95.0|0.71|1.2|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.20|0.71|0.531
71113599|NCT02993822|141734888|SUPERIORITY||Mean Difference (Final Values)|0.93||||0.482|TWO_SIDED|95.0|0.75|1.15|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.15|0.75|0.482
71113600|NCT02993822|141734888|SUPERIORITY||Mean Difference (Final Values)|0.92||||0.46|TWO_SIDED|95.0|0.75|1.14|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.14|0.75|0.460
70941945|NCT00385697|141384030|SUPERIORITY||Odds Ratio (OR)|1.265||||0.404|TWO_SIDED|95.0|0.727|2.2|||Mantel Haenszel|||||2.200|0.727|0.404
70941946|NCT00385697|141384030|SUPERIORITY||Odds Ratio (OR)|0.805||||0.528|TWO_SIDED|95.0|0.412|1.576|||Mantel Haenszel|||||1.576|0.412|0.528
70941947|NCT00385697|141384030|SUPERIORITY||Odds Ratio (OR)|1.133||||0.706|TWO_SIDED|95.0|0.594|2.164|||Mantel Haenszel|||||2.164|0.594|0.706
71113601|NCT02993822|141734888|SUPERIORITY||Mean Difference (Final Values)|0.86||||0.144|TWO_SIDED|95.0|0.69|1.06|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.06|0.69|0.144
71113602|NCT02993822|141734889|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.992|TWO_SIDED|95.0|0.78|1.27|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.27|0.78|0.992
71113603|NCT02993822|141734889|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.387|TWO_SIDED|95.0|0.71|1.14|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.14|0.71|0.387
71113604|NCT02993822|141734889|SUPERIORITY||Mean Difference (Final Values)|0.94||||0.6|TWO_SIDED|95.0|0.74|1.19|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.19|0.74|0.600
71113605|NCT02993822|141734890|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.042|TWO_SIDED|95.0|0.0|2.0|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.0|0.0|0.042
71113606|NCT02993822|141734890|SUPERIORITY||Median Difference (Final Values)|1.1||||0.026|TWO_SIDED|95.0|0.1|2.0|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.0|0.1|0.026
71113607|NCT02993822|141734890|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.003|TWO_SIDED|95.0|0.5|2.4|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.4|0.5|0.003
70941948|NCT00385697|141384032|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.872|TWO_SIDED|95.0|-0.455|0.536|||ANCOVA|||||0.536|-0.455|0.872
70941949|NCT00385697|141384032|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.979|TWO_SIDED|95.0|-0.581|0.556|||ANCOVA|||||0.556|-0.581|0.979
70941950|NCT00385697|141384032|SUPERIORITY||Mean Difference (Final Values)|-0.225||||0.4|TWO_SIDED|95.0|-0.75|0.301|||ANCOVA|||||0.301|-0.750|0.400
71113608|NCT02993822|141734891|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.25|TWO_SIDED|95.0|-0.4|1.7|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||1.7|-0.4|0.250
71113609|NCT02993822|141734891|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.325|TWO_SIDED|95.0|-0.5|1.5|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||1.5|-0.5|0.325
70939074|NCT01989156|141378901|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|12.58|||<|0.001|TWO_SIDED|95.0|9.27|17.05||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS Mean Ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the biomarkers of exposure (BoExp) was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||17.05|9.27|<0.001
70939075|NCT01989156|141378902|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|45.77|||<|0.001|TWO_SIDED|95.0|39.22|53.41||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on 3-HPMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||53.41|39.22|<0.001
71070459|NCT03369067|141649808|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71113610|NCT02993822|141734891|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.029|TWO_SIDED|95.0|0.1|2.2|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.2|0.1|0.029
71070460|NCT03369067|141649809|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71113611|NCT02993822|141734892|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.038|TWO_SIDED|95.0|0.1|2.3|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.3|0.1|0.038
71070461|NCT03369067|141649809|OTHER|||||||0.044||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.044
71070462|NCT03369067|141649809|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070463|NCT03369067|141649810|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71113612|NCT02993822|141734892|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.118|TWO_SIDED|95.0|-0.2|2.0|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.0|-0.2|0.118
71113613|NCT02993822|141734892|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.025|TWO_SIDED|95.0|0.2|2.4|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.4|0.2|0.025
71113614|NCT02993822|141734893|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.258|TWO_SIDED|95.0|-0.5|1.9|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||1.9|-0.5|0.258
71113615|NCT02993822|141734893|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.243|TWO_SIDED|95.0|-0.5|1.8|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||1.8|-0.5|0.243
71113616|NCT02993822|141734893|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.009|TWO_SIDED|95.0|0.4|2.8|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.8|0.4|0.009
71070464|NCT03369067|141649810|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070465|NCT03369067|141649810|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070466|NCT03369067|141649811|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070467|NCT03369067|141649811|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070468|NCT03369067|141649811|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070469|NCT03369067|141649812|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070470|NCT03369067|141649812|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070471|NCT03369067|141649812|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070472|NCT03369067|141649813|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070473|NCT03369067|141649813|OTHER|||||||0.141||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||0.141
71070474|NCT03369067|141649813|OTHER|||||||0.149||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||0.149
71070475|NCT03369067|141649814|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070476|NCT03369067|141649814|OTHER|||||||0.094||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||0.094
71070477|NCT03369067|141649814|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070478|NCT03369067|141649815|OTHER||||||<|0.001||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||<0.001
71070479|NCT03369067|141649815|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070480|NCT03369067|141649815|OTHER|||||||0.033||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.033
71070481|NCT03369067|141649816|OTHER|||||||0.001||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.001
71070482|NCT03369067|141649816|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070483|NCT03369067|141649816|OTHER|||||||0.111||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.111
71070484|NCT03369067|141649817|OTHER|||||||0.118||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.118
71070485|NCT03369067|141649817|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070486|NCT03369067|141649817|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070487|NCT03369067|141649818|OTHER|||||||0.116||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.116
71070488|NCT03369067|141649818|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070489|NCT03369067|141649818|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070490|NCT03369067|141649819|OTHER|||||||0.005||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.005
71070491|NCT03369067|141649819|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71113617|NCT02993822|141734894|SUPERIORITY||Mean Difference (Final Values)|-9.6||||0.008|TWO_SIDED|95.0|-16.6|-2.5|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-2.5|-16.6|0.008
71113618|NCT02993822|141734894|SUPERIORITY||Mean Difference (Final Values)|-4.5||||0.198|TWO_SIDED|95.0|-11.4|2.4|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||2.4|-11.4|0.198
71113619|NCT02993822|141734894|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.055|TWO_SIDED|95.0|-13.7|0.1|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||0.1|-13.7|0.055
71113620|NCT02993822|141734895|SUPERIORITY||Mean Difference (Final Values)|-8.7||||0.026|TWO_SIDED|95.0|-16.3|-1.1|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-1.1|-16.3|0.026
71113621|NCT02993822|141734895|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.571|TWO_SIDED|95.0|-9.6|5.3|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||5.3|-9.6|0.571
71113622|NCT02993822|141734895|SUPERIORITY||Mean Difference (Final Values)|-7.7||||0.043|TWO_SIDED|95.0|-15.2|-0.3|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-0.3|-15.2|0.043
71113623|NCT02993822|141734896|SUPERIORITY||Mean Difference (Final Values)|-11.5||||0.006|TWO_SIDED|95.0|-19.7|-3.3|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-3.3|-19.7|0.006
70941951|NCT00714688|141384215|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|-2.7|STANDARD_ERROR_OF_MEAN|1.51||0.136||95.0|-6.04|0.67||The p value was adjusted for multiplicity via Dunnett's test procedure.|ANCOVA|Treatment, gender and country were used as factors and baseline value and age were used as covariates.||Statistical analysis of change from baseline at endpoint.||0.67|-6.04|0.136
71113624|NCT02993822|141734896|SUPERIORITY||Mean Difference (Final Values)|-3.1||||0.435|TWO_SIDED|95.0|-11.1|4.8|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||4.8|-11.1|0.435
71113625|NCT02993822|141734896|SUPERIORITY||Mean Difference (Final Values)|-9.4||||0.022|TWO_SIDED|95.0|-17.4|-1.4|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-1.4|-17.4|0.022
71113626|NCT02993822|141734897|SUPERIORITY||Mean Difference (Final Values)|-7.0||||0.103|TWO_SIDED|95.0|-15.3|1.4|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||1.4|-15.3|0.103
71113627|NCT02993822|141734897|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.546|TWO_SIDED|95.0|-10.6|5.6|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||5.6|-10.6|0.546
71113628|NCT02993822|141734897|SUPERIORITY||Mean Difference (Final Values)|-9.0||||0.034|TWO_SIDED|95.0|-17.2|-0.7|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-0.7|-17.2|0.034
71113629|NCT02993822|141734898|SUPERIORITY||Mean Difference (Final Values)|-11.2||||0.004|TWO_SIDED|95.0|-18.8|-3.6|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-3.6|-18.8|0.004
71113630|NCT02993822|141734898|SUPERIORITY||Mean Difference (Final Values)|-4.1||||0.282|TWO_SIDED|95.0|-11.5|3.4|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||3.4|-11.5|0.282
70939076|NCT01989156|141378903|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|12.58|||<|0.001|TWO_SIDED|95.0|9.54|16.58||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on S-PMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||16.58|9.54|<0.001
70939077|NCT01989156|141378904|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|26.41|||<|0.001|TWO_SIDED|95.0|17.31|40.26||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on Total NNAL levels with product, sex, cigarette consumption, and baseline value as covariates|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 90 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 90 for mTHS 2.2 and mCC respectively."||40.26|17.31|<0.001
70939078|NCT01989156|141378905|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|38.14|||<|0.001|TWO_SIDED|95.0|34.24|42.47||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on COHb levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 90 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 90 for mTHS 2.2 and mCC respectively."||42.47|34.24|<0.001
70939079|NCT01721109|141378911|EQUIVALENCE|A sample size of 14 participants was estimated to provide over 95% power to show pharmacokinetic equivalence between adult and adolescent participants. EVG population PK from historical adult data was used for comparison. The inter-subject standard deviation (natural log scale) of EVG AUCtau observed in the population PK data was 0.31 (historical data).|Geometric least squares mean ratio|1.3029|||||TWO_SIDED|90.0|1.0479|1.62||||||||1.6200|1.0479|
70939080|NCT01426217|141378960|OTHER|Efficacy|Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.63|0.98||||||||0.98|0.63|
70939081|NCT01426217|141378961|OTHER|Efficacy|Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.62|1.35||||||||1.35|0.62|
71070492|NCT03369067|141649819|OTHER|||||||0.193||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.193
71070493|NCT03369067|141649820|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070494|NCT03369067|141649820|OTHER|||||||0.106||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.106
71070495|NCT03369067|141649820|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070496|NCT03369067|141649821|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71113631|NCT02993822|141734898|SUPERIORITY||Mean Difference (Final Values)|-3.2||||0.398|TWO_SIDED|95.0|-10.7|4.3|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||4.3|-10.7|0.398
71113632|NCT02993822|141734899|SUPERIORITY||Mean Difference (Final Values)|-10.0||||0.019|TWO_SIDED|95.0|-18.3|-1.7|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-1.7|-18.3|0.019
71113633|NCT02993822|141734899|SUPERIORITY||Mean Difference (Final Values)|-5.6||||0.17|TWO_SIDED|95.0|-13.7|2.4|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||2.4|-13.7|0.170
71070497|NCT03369067|141649821|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070498|NCT03369067|141649821|OTHER|||||||0.157||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.157
71070499|NCT03369067|141649822|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71113634|NCT02993822|141734899|SUPERIORITY||Mean Difference (Final Values)|-3.6||||0.384|TWO_SIDED|95.0|-11.7|4.5|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||4.5|-11.7|0.384
71113635|NCT02993822|141734900|SUPERIORITY||Mean Difference (Final Values)|-11.7||||0.006|TWO_SIDED|95.0|-20.0|-3.3|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-3.3|-20.0|0.006
70939082|NCT02991456|141379022|OTHER|||||||0.2734|||||||Chi-squared|||||||0.2734
71070500|NCT03369067|141649822|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070501|NCT03369067|141649822|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070502|NCT03369067|141649823|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070503|NCT03369067|141649823|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070504|NCT03369067|141649823|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070505|NCT03369067|141649824|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
70939083|NCT02991456|141379023|OTHER|||||||0.7091|||||||Chi-squared|||||||0.7091
71070506|NCT03369067|141649824|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070507|NCT03369067|141649824|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71113636|NCT02993822|141734900|SUPERIORITY||Mean Difference (Final Values)|-5.0||||0.222|TWO_SIDED|95.0|-13.0|3.0|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||3.0|-13.0|0.222
70939084|NCT02991456|141379024|EQUIVALENCE|This was tested as patients who preferred rolapitant + ondansetron vs. patients who did not prefer rolapitant + ondansetron. Patients who reported no preference and preference to Ondansetron were combined.||||||0.0004|||||||Exact Binomial|||||||0.0004
70939085|NCT02991456|141379024|EQUIVALENCE|Three outcomes tested by sequence.||||||0.5207|||||||Fisher Exact|||||||0.5207
71070508|NCT03369067|141649825|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070509|NCT03369067|141649825|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070510|NCT03369067|141649825|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070511|NCT03369067|141649826|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070512|NCT03369067|141649826|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070513|NCT03369067|141649826|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71070514|NCT03369067|141649827|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070515|NCT03369067|141649827|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
70939086|NCT02991456|141379025|EQUIVALENCE|Effectiveness during weeks 1-3 between sequences.||||||0.0406|||||||t-test, 1 sided|T-test using the Satterthwaite method for unequal variances.||||||0.0406
70939087|NCT02991456|141379026|EQUIVALENCE|Convenience during weeks 1-3 between sequences.||||||0.0541|||||||t-test, 1 sided|T-test using the pooled method for equal variances.||||||0.0541
71070516|NCT03369067|141649827|OTHER|||||||0.073||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.073
71070517|NCT03369067|141649828|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070518|NCT03369067|141649828|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070519|NCT03369067|141649828|OTHER|||||||0.064||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.064
71070520|NCT03369067|141649829|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070521|NCT03369067|141649829|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070522|NCT03369067|141649829|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71113637|NCT02993822|141734900|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.058|TWO_SIDED|95.0|-16.0|0.3|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||0.3|-16.0|0.058
70939088|NCT02991456|141379027|EQUIVALENCE|Overall satisfaction during weeks 1-3 between sequences.||||||0.0781|||||||t-test, 1 sided|T-test using the pooled method for equal variances.||||||0.0781
70939089|NCT02991456|141379028|EQUIVALENCE|Effectiveness during weeks 4-6 between sequences.||||||0.4146|||||||t-test, 1 sided|T-test using the pooled method for equal variances.||||||0.4146
71070523|NCT03369067|141649830|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
70939090|NCT02991456|141379029|EQUIVALENCE|Convenience during weeks 4-6 between sequences.||||||0.2214|||||||t-test, 1 sided|T-test using the pooled method for equal variances.||||||0.2214
71070524|NCT03369067|141649830|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070525|NCT03369067|141649830|OTHER|||||||0.104||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.104
70939091|NCT02991456|141379030|EQUIVALENCE|Overall satisfaction during weeks 4-6 between sequences.||||||0.2028|||||||t-test, 1 sided|T-test using the Satterthwaite method for unequal variances.||||||0.2028
70939092|NCT00738400|141379048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.76|||<|0.0001||95.0|-9.03|-4.49|||ANCOVA|||ANCOVA, baseline covariate, endpoint week 8 or LOCF. Factors: treatment, pooled centers. Ls mean at endpoint||-4.49|-9.03|<0.0001
71070526|NCT03369067|141649831|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070527|NCT03369067|141649831|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070528|NCT03369067|141649831|OTHER|||||||0.198||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.198
71070529|NCT03369067|141649832|OTHER|||||||0.105||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.105
71070530|NCT03369067|141649832|OTHER|||||||0.001||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.001
71070531|NCT03369067|141649832|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070532|NCT03369067|141649833|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070533|NCT03369067|141649833|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71070534|NCT03369067|141649833|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71113638|NCT02993822|141734901|SUPERIORITY||Mean Difference (Final Values)|-10.0||||0.027|TWO_SIDED|95.0|-18.9|-1.2|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-1.2|-18.9|0.027
71113639|NCT02993822|141734901|SUPERIORITY||Mean Difference (Final Values)|-6.4||||0.147|TWO_SIDED|95.0|-14.9|2.2|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||2.2|-14.9|0.147
71113640|NCT02993822|141734901|SUPERIORITY||Mean Difference (Final Values)|-8.9||||0.046|TWO_SIDED|95.0|-17.6|-0.1|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-0.1|-17.6|0.046
71113641|NCT02993822|141734902|SUPERIORITY||Mean Difference (Final Values)|-12.5|||<|0.001|TWO_SIDED|95.0|-19.5|-5.5|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-5.5|-19.5|<0.001
70939093|NCT00738400|141379049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.71|||<|0.0001||95.0|-30.66|-10.76|||ANCOVA|||ANCOVA, baseline covariate, endpoint week 8 or LOCF. Factors: treatment, pooled centers. Ls mean at endpoint||-10.76|-30.66|<0.0001
70939094|NCT00738400|141379050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.16|||<|0.0001||95.0|-37.48|-14.83|||ANCOVA|||ANCOVA, baseline covariate, endpoint week 8 or LOCF. Factors: treatment, pooled centers. Ls mean at endpoint||-14.83|-37.48|<0.0001
70939095|NCT00738400|141379051|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Mantel Haenszel|||Mantel-Haenszel Test||||0.0004
71070535|NCT00459706|141649869|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority test was performed using the 95 percent (%) two-sided confidence interval (CI) of the difference (AI minus PFS) of mean subject satisfactions (α = 2.5%).~Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI \> -1."|Mean Difference (Net)|1.11|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|0.71|1.5|||ANOVA|ANOVA=analysis of variance||Non-inferiority of autoinjector (AI) over prefilled syringe (PFS) was assessed on the primary endpoint. Hypothesis tested was H0: AI minus PFS less than or equal to (≤) -1. The alternate hypothesis was H1: AI minus PFS greater than (\>) -1.||1.50|0.71|<0.001
71070536|NCT00459706|141649870|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority test was performed using the 95% two-sided CI of the difference (AI minus PFS) of mean subject satisfactions (α = 2.5%).~Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI \> -1."|Mean Difference (Net)|1.25|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|0.85|1.64|||ANOVA|||"Non-inferiority of AI over PFS was assessed on the primary endpoint. The hypotheses tested was as follows:~H0: AI - PFS ≤ -1 H1: AI - PFS \> -1"||1.64|0.85|<0.001
71070537|NCT00459706|141649871|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.058|TWO_SIDED|95.0|0.98|3.05|||GEE Model+Logit Link+Binomial Distributn|GEE=Generalized estimating equation Distribn=distribution||||3.05|0.98|0.058
71070538|NCT00459706|141649872|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96||||0.019|TWO_SIDED|95.0|1.12|3.43|||GEE Model+Logit Link+Binomial Distributn|||||3.43|1.12|0.019
71113642|NCT02993822|141734902|SUPERIORITY||Mean Difference (Final Values)|-5.5||||0.114|TWO_SIDED|95.0|-12.4|1.3|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||1.3|-12.4|0.114
71070539|NCT00459706|141649873|SUPERIORITY_OR_OTHER||Regression coefficient|0.11||||0.16|TWO_SIDED|95.0|-0.04|0.27|||Regression, Linear|||All categories||0.27|-0.04|0.160
71070540|NCT00459706|141649874|SUPERIORITY_OR_OTHER||Regression coefficients|-0.75||||0.001|TWO_SIDED|95.0|-1.2|-0.29|||Regression, Linear|||Female versus male (reference).||-0.29|-1.20|0.001
71070541|NCT00459706|141649875|SUPERIORITY_OR_OTHER||Regression coefficient|-0.18||||0.676|TWO_SIDED|95.0|-0.62|0.26|||Regression, Linear|||Participants at High School/Baccalaureate Level versus participants with only Reading/Writing Capacity (reference).||0.26|-0.62|0.676
71070542|NCT00459706|141649875|SUPERIORITY_OR_OTHER||Regression coefficient|0.0||||0.676|TWO_SIDED|95.0|-0.59|0.6|||Regression, Linear|||Participants at University Level versus participants with only Reading/Writing Capacity (reference).||0.60|-0.59|0.676
70939096|NCT00738400|141379052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.57||||0.0003||95.0|-23.8|-7.34|||ANCOVA|||ANCOVA, baseline covariate, endpoint week 8 or LOCF. Factors: treatment, pooled centers. Ls mean at endpoint||-7.34|-23.80|0.0003
71070543|NCT00459706|141649876|SUPERIORITY_OR_OTHER||Regression coefficient|-0.28||||0.02|TWO_SIDED|95.0|-0.52|-0.05|||Regression, Linear|||All categories||-0.05|-0.52|0.020
71070544|NCT00459706|141649877|SUPERIORITY_OR_OTHER||Regression coefficient|-0.35||||0.008|TWO_SIDED|95.0|-0.61|-0.09|||Regression, Linear|||All categories||-0.09|-0.61|0.008
71070545|NCT00459706|141649878|SUPERIORITY_OR_OTHER||Regression coefficient|0.17||||0.03|TWO_SIDED|95.0|0.02|0.32|||Regression, Linear|||All categories||0.32|0.02|0.030
71070546|NCT00459706|141649879|SUPERIORITY_OR_OTHER||Regression coefficient|-0.6||||0.006|TWO_SIDED|95.0|-1.03|-0.18|||Regression, Linear|||Self-injection Experience versus No Self-injection Experience (reference).||-0.18|-1.03|0.006
71070547|NCT00459706|141649880|SUPERIORITY_OR_OTHER||Regression coefficient|0.06||||0.278|TWO_SIDED|95.0|-0.05|0.18|||Regression, Linear|||All categories||0.18|-0.05|0.278
71070548|NCT00459706|141649881|SUPERIORITY_OR_OTHER||Regression coefficient|0.03||||0.749|TWO_SIDED|95.0|-0.15|0.21|||Regression, Linear|||All categories||0.21|-0.15|0.749
70939097|NCT00738400|141379053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.33|||<|0.0001||95.0|-37.24|-17.43|||ANCOVA|||ANCOVA, baseline covariate, endpoint week 8 or LOCF. Factors: treatment, pooled centers. Ls mean at endpoint||-17.43|-37.24|<0.0001
70939098|NCT03677986|141379079|SUPERIORITY||Odds Ratio (OR)|0.92||||0.914|TWO_SIDED|95.0|0.21|4.14|||GEE|||||4.14|.21|0.914
70939099|NCT00424502|141379082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.017|STANDARD_DEVIATION|1.34|<|0.0001|TWO_SIDED|95.0|1.39|2.64|||t-test, 2 sided|||Change from Baseline to Week 24||2.64|1.39|<0.0001
70939100|NCT00424502|141379083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.276|STANDARD_DEVIATION|0.259|<|0.0001|TWO_SIDED|95.0|0.151|0.401|||t-test, 2 sided|||Change from baseline to Week 24||0.401|0.151|<0.0001
70939101|NCT00424502|141379086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.4|STANDARD_DEVIATION|23.24||0.012|TWO_SIDED|95.0|3.52|25.28|||t-test, 2 sided|||Change from baseline to Week 24||25.28|3.52|0.012
70939102|NCT00424502|141379087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81|STANDARD_DEVIATION|8.21||0.337|TWO_SIDED|95.0|-2.03|5.65|||t-test, 2 sided|||Change from baseline to Week 24||5.65|-2.03|0.337
70939103|NCT04448561|141379101|OTHER||Geometric Least square (LS) mean ratio|100.64|||||TWO_SIDED|90.0|98.37|102.96|||||Assessment based on analysis of variance performed on natural log-transformed parameters with treatment as fixed effect and participant as random effect. Ratios and confidence limits: transformed back to raw scale and values expressed as percentages.|||102.96|98.37|
71070549|NCT00459706|141649882|SUPERIORITY_OR_OTHER||Regression coefficient|-0.08||||0.105|TWO_SIDED|95.0|-0.18|0.02|||Regression, Linear|||All categories||0.02|-0.18|0.105
71070550|NCT00459706|141649883|SUPERIORITY_OR_OTHER||Regression coefficient|0.01||||0.819|TWO_SIDED|95.0|-0.1|0.12|||Regression, Linear|||All categories||0.12|-0.10|0.819
71070551|NCT00459706|141649884|SUPERIORITY_OR_OTHER||Regression coefficient|-0.39||||0.012|TWO_SIDED|95.0|-0.69|-0.09|||Regression, Linear|||All categories, by 1-unit increments.||-0.09|-0.69|0.012
71070552|NCT00459706|141649885|SUPERIORITY_OR_OTHER||Regression coefficient|-0.1||||0.541|TWO_SIDED|95.0|-0.52|0.32|||Regression, Linear|||2 DMARDs versus 1 DMARD (reference).||0.32|-0.52|0.541
71070553|NCT00459706|141649885|SUPERIORITY_OR_OTHER||Regression coefficient|-0.14||||0.541|TWO_SIDED|95.0|-0.97|0.68|||Regression, Linear|||3 DMARDs versus 1 DMARD (reference).||0.68|-0.97|0.541
71070554|NCT00459706|141649885|SUPERIORITY_OR_OTHER||Regression coefficient|1.72||||0.541|TWO_SIDED|95.0|-0.82|4.25|||Regression, Linear|||At least 4 DMARDs versus 1 DMARD (reference).||4.25|-0.82|0.541
71070555|NCT00459706|141649886|SUPERIORITY_OR_OTHER||Regression coefficient|-0.15||||0.465|TWO_SIDED|95.0|-0.55|0.25|||Regression, Linear|||Prior Injection Experience versus No Prior Injection Experience (reference)||0.25|-0.55|0.465
71070556|NCT00459706|141649887|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|0.29||0.154|TWO_SIDED|95.0|-0.97|0.15|||ANOVA|||||0.15|-0.97|0.154
71070557|NCT00459706|141649888|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.17||0.212|TWO_SIDED|95.0|-0.12|0.56|||ANOVA|||||0.56|-0.12|0.212
71070558|NCT00459706|141649889|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.19||0.965|TWO_SIDED|95.0|-0.39|0.37|||ANOVA|||||0.37|-0.39|0.965
71070559|NCT00459706|141649890|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.19||0.519|TWO_SIDED|95.0|-0.25|0.5|||ANOVA|||||0.50|-0.25|0.519
71070560|NCT00459706|141649891|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85|||<|0.001|TWO_SIDED|95.0|1.33|2.57|||GEE model+logit link+multinomial distrib|||Day 84||2.57|1.33|<0.001
71070561|NCT00459706|141649892|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.007|TWO_SIDED|95.0|1.14|2.29|||GEE model+logit link+multinomial distrib|||||2.29|1.14|0.007
71070562|NCT00459706|141649893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92||||0.002|TWO_SIDED|95.0|1.26|2.92|||GEE model+logit link+multinomial distrib|||||2.92|1.26|0.002
71070563|NCT00459706|141649894|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39|||<|0.001|TWO_SIDED|95.0|1.65|3.46|||GEE model+logit link+multinomial distrib|||||3.46|1.65|<0.001
71070564|NCT00459706|141649895|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06|||<|0.001|TWO_SIDED|95.0|1.5|2.83|||GEE model+logit link+multinomial distrib|||||2.83|1.50|<0.001
71070565|NCT00459706|141649896|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0|||<|0.001|TWO_SIDED|95.0|1.44|2.78|||GEE model+logit link+multinomial distrib|||||2.78|1.44|<0.001
70939104|NCT04448561|141379102|OTHER||Geometric LS mean ratio|94.28|||||TWO_SIDED|90.0|89.29|99.54|||||Assessment based on analysis of variance performed on natural log-transformed parameters with treatment as fixed effect and participant as random effect. Ratios and confidence limits: transformed back to raw scale and values expressed as percentages.|||99.54|89.29|
70939105|NCT04448561|141379104|OTHER||Geometric LS mean ratio|100.79|||||TWO_SIDED|90.0|83.35|121.88|||||Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits were transformed back to raw scale and values were expressed as percentages.|||121.88|83.35|
71070566|NCT00459706|141649897|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.184|TWO_SIDED|95.0|0.9|1.72|||GEE model+logit link+multinomial distrib|||||1.72|0.90|0.184
71070567|NCT00459706|141649898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.106|TWO_SIDED|95.0|0.94|1.85|||GEE model+logit link+multinomial distrib|||||1.85|0.94|0.106
71070568|NCT00459706|141649899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.112|TWO_SIDED|95.0|0.93|1.96|||GEE model+logit link+multinomial distrib|||||1.96|0.93|0.112
71070569|NCT00459706|141649900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.002|TWO_SIDED|95.0|1.21|2.24|||GEE model+logit link+multinomial distrib|||||2.24|1.21|0.002
71070570|NCT00459706|141649901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.57|||<|0.001|TWO_SIDED|95.0|0.41|0.78|||GEE model+logit link+multinomial distrib|||||0.78|0.41|<0.001
71070571|NCT00459706|141649902|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.022|TWO_SIDED|95.0|0.47|0.94|||GEE model+logit link+multinomial distrib|||||0.94|0.47|0.022
71070572|NCT00459706|141649903|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.009|TWO_SIDED|95.0|0.46|0.89|||GEE model+logit link+multinomial distrib|||||0.89|0.46|0.009
71070573|NCT00459706|141649904|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63||||0.007|TWO_SIDED|95.0|0.45|0.88|||GEE model+logit link+multinomial distrib|||||0.88|0.45|0.007
71113643|NCT02993822|141734902|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.056|TWO_SIDED|95.0|-13.7|0.2|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||0.2|-13.7|0.056
71113644|NCT02993822|141734903|SUPERIORITY||Mean Difference (Final Values)|-8.9||||0.027|TWO_SIDED|95.0|-16.8|-1.0|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-1.0|-16.8|0.027
71113645|NCT02993822|141734903|SUPERIORITY||Mean Difference (Final Values)|-3.6||||0.357|TWO_SIDED|95.0|-11.3|4.1|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||4.1|-11.3|0.357
71113646|NCT02993822|141734903|SUPERIORITY||Mean Difference (Final Values)|-8.5||||0.031|TWO_SIDED|95.0|-16.2|-0.8|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-0.8|-16.2|0.031
71070574|NCT00459706|141649905|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.014|TWO_SIDED|95.0|0.47|0.92|||GEE model+logit link+multinomial distrib|||||0.92|0.47|0.014
71070575|NCT00459706|141649906|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||<|0.001|TWO_SIDED|95.0|1.53|2.88|||GEE model+logit link+multinomial distrib|||||2.88|1.53|<0.001
71070576|NCT00459706|141649907|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.14|||<|0.001|TWO_SIDED|95.0|1.57|2.91|||GEE model+logit link+multinomial distrib|||||2.91|1.57|<0.001
71070577|NCT00459706|141649908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.08|||<|0.001|TWO_SIDED|95.0|2.23|4.25|||GEE model+logit link+multinomial distrib|||||4.25|2.23|<0.001
71070578|NCT00459706|141649909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88|||<|0.001|TWO_SIDED|95.0|1.35|2.62|||GEE model+logit link+multinomial distrib|||||2.62|1.35|<0.001
71070579|NCT00459706|141649910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.25|||<|0.001|TWO_SIDED|95.0|0.18|0.34|||GEE model+logit link+multinomial distrib|||||0.34|0.18|<0.001
71070580|NCT00459706|141649911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.26|||<|0.001|TWO_SIDED|95.0|0.19|0.36|||GEE model+logit link+multinomial distrib|||||0.36|0.19|<0.001
71070581|NCT00459706|141649912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27|||<|0.001|TWO_SIDED|95.0|0.2|0.36|||GEE model+logit link+multinomial distrib|||||0.36|0.20|<0.001
71070582|NCT00459706|141649913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.196|TWO_SIDED|95.0|0.61|1.11|||GEE model+logit link+multinomial distrib|||||1.11|0.61|0.196
71070583|NCT00459706|141649914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74||||0.001|TWO_SIDED|95.0|1.25|2.42|||GEE model+logit link+multinomial distrib|||||2.42|1.25|0.001
71070584|NCT00459706|141649915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3|||<|0.001|TWO_SIDED|95.0|0.21|0.42|||GEE model+logit link+multinomial distrib|||||0.42|0.21|<0.001
71070585|NCT00459706|141649916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4|||<|0.001|TWO_SIDED|95.0|0.29|0.56|||GEE model+logit link+multinomial distrib|||||0.56|0.29|<0.001
71070586|NCT00459706|141649917|SUPERIORITY_OR_OTHER|||||||0.896|TWO_SIDED||||||ANOVA|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.896
71113647|NCT02993822|141734904|SUPERIORITY||Mean Difference (Final Values)|-11.1||||0.008|TWO_SIDED|95.0|-19.2|-2.9|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-2.9|-19.2|0.008
71113648|NCT02993822|141734904|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.321|TWO_SIDED|95.0|-11.8|3.9|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||3.9|-11.8|0.321
71113649|NCT02993822|141734904|SUPERIORITY||Mean Difference (Final Values)|-8.1||||0.047|TWO_SIDED|95.0|-16.0|-0.1|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-0.1|-16.0|0.047
71113650|NCT02993822|141734905|SUPERIORITY||Mean Difference (Final Values)|-10.1||||0.018|TWO_SIDED|95.0|-18.4|-1.8|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-1.8|-18.4|0.018
70939106|NCT04448561|141379105|OTHER||Geometric LS mean ratio|100.58|||||TWO_SIDED|90.0|81.35|124.36|||||Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits were transformed back to raw scale and values were expressed as percentages.|||124.36|81.35|
70939107|NCT04448561|141379107|OTHER||Geometric LS mean ratio|89.08|||||TWO_SIDED|90.0|79.58|99.71|||||Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits were transformed back to raw scale and values were expressed as percentages.|||99.71|79.58|
70939108|NCT04448561|141379108|OTHER||Geometric LS mean ratio|96.11|||||TWO_SIDED|90.0|83.03|111.25|||||Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits are transformed back to raw scale and values are expressed as percentages.|||111.25|83.03|
70939109|NCT04448561|141379110|OTHER||Geometric LS mean ratio|86.54|||||TWO_SIDED|90.0|76.01|98.52|||||Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits are transformed back to raw scale and values are expressed as percentages.|||98.52|76.01|
70939110|NCT04448561|141379111|OTHER||Geometric LS mean ratio|95.1|||||TWO_SIDED|90.0|82.52|109.6|||||Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits were transformed back to raw scale and values were expressed as percentages.|||109.60|82.52|
71113651|NCT02993822|141734905|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.682|TWO_SIDED|95.0|-9.8|6.4|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||6.4|-9.8|0.682
71113652|NCT02993822|141734905|SUPERIORITY||Mean Difference (Final Values)|-11.8||||0.005|TWO_SIDED|95.0|-20.0|-3.6|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-3.6|-20.0|0.005
71113653|NCT02993822|141734906|SUPERIORITY|||||||0.004|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.004
71113654|NCT02993822|141734906|SUPERIORITY|||||||0.134|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.134
71113655|NCT02993822|141734906|SUPERIORITY|||||||0.003|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.003
71113656|NCT02993822|141734907|SUPERIORITY|||||||0.401|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.401
71113657|NCT02993822|141734907|SUPERIORITY|||||||0.175|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.175
71113658|NCT02993822|141734907|SUPERIORITY|||||||0.126|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.126
70939111|NCT05356130|141379114|SUPERIORITY|||||||0.014|||||||Mixed Models Analysis|||"We conducted the same two independent planned comparisons: Enhanced BLT Encouragement + Adherence Promotion compared to Minimal BLT Encouragement; Minimal BLT Encouragement and Enhanced BLT Encouragement + Adherence Promotion compared to TAU."||||0.014
70939112|NCT03141177|141379115|SUPERIORITY|Treatment A over Treatment C|Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.41|0.64|||Stratified Log-Rank|||||0.64|0.41|<0.0001
70939113|NCT03141177|141379116|SUPERIORITY|Treatment A over Treatment C|Hazard Ratio (HR)|0.6||||0.001|TWO_SIDED|98.89|0.4|0.89|||Stratified Log-Rank|||||0.89|0.40|0.0010
70939114|NCT03141177|141379117|SUPERIORITY|Treatment A over Treatment C|Odds Ratio (OR)|3.52|||<|0.0001|TWO_SIDED|95.0|2.51|4.95|||Stratified Cochran-Mantel-Haenszel|||||4.95|2.51|<0.0001
70939115|NCT03141177|141379117|OTHER|Treatment A - Treatment C|Difference of Objective Response Rates|28.6|||||TWO_SIDED|95.0|21.7|35.6|||||Strata adjusted difference in objective response rate (Nivolumab+Cabozantinib - Sunitinib) based on DerSimonian and Laird.|||35.6|21.7|
70939116|NCT02680314|141379125|SUPERIORITY|||||||0.202|||||||Wilcoxon (Mann-Whitney)|||||||0.202
71113659|NCT02993822|141734908|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.002
71113660|NCT02993822|141734908|SUPERIORITY|||||||0.144|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.144
71113661|NCT02993822|141734908|SUPERIORITY|||||||0.025|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.025
70939117|NCT05361304|141379144|NON_INFERIORITY||Least square Mean (LSM) Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.012|||TWO_SIDED|95.0|-0.04|0.0|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|LSM difference was calculated as Senofilcon A contact lenses made with a novel manufacturing technology minus Senofilcon A contact lenses made with the current manufacturing technology|It was calculated using a 2 independent sample means t-test with a 2-sided type I error rate of 5% with at least 80% statistical power, that 100 subjects were required to test for non-inferiority of the Senofilcon A contact lenses made with a novel manufacturing technology compared to the Senofilcon A contact lenses made with the current manufacturing technology for distance (4m) under HLLC.||0.000|-0.040|
70939118|NCT05361304|141379144|NON_INFERIORITY||Least square Mean (LSM) Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.012|||TWO_SIDED|95.0|-0.03|0.02|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|LSM difference was calculated as Senofilcon A contact lenses made with a novel manufacturing technology minus Senofilcon A contact lenses made with the current manufacturing technology|It was calculated using a 2 independent sample means t-test with a 2-sided type I error rate of 5% with at least 80% statistical power, that 100 subjects were required to test for non-inferiority of the Senofilcon A contact lenses made with a novel manufacturing technology compared to the Senofilcon A contact lenses made with the current manufacturing technology for distance (4m) under LLHC.||0.020|-0.030|
70941952|NCT00714688|141384215|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|-4.9|STANDARD_ERROR_OF_MEAN|1.5||0.002||95.0|-8.22|-1.55||The p value was adjusted for multiplicity via Dunnett's test procedure.|ANCOVA|Treatment, gender and country were used as factors and baseline value and age were used as covariates.||Statistical analysis of change from baseline at endpoint.||-1.55|-8.22|0.002
71113662|NCT02993822|141734909|SUPERIORITY|||||||0.158|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.158
71113663|NCT02993822|141734909|SUPERIORITY|||||||0.597|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.597
71113664|NCT02993822|141734909|SUPERIORITY|||||||0.124|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.124
71113665|NCT02993822|141734910|SUPERIORITY|||||||0.01|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.01
71113666|NCT02993822|141734910|SUPERIORITY|||||||0.049|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.049
71113667|NCT02993822|141734910|SUPERIORITY|||||||0.001|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.001
71113668|NCT02993822|141734911|SUPERIORITY|||||||0.309|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.309
70941953|NCT00714688|141384216|SUPERIORITY_OR_OTHER|||||||0.216||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|The ANCOVA model was performed on ranked data. Treatment, gender \& country were used as factors and baseline value \& age were used as covariates.||Statistical analysis of change from baseline at endpoint.||||0.216
71070587|NCT00459706|141649917|SUPERIORITY_OR_OTHER|||||||0.166|TWO_SIDED||||||ANOVA|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.166
71070588|NCT00459706|141649918|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.069
71070589|NCT00459706|141649918|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.015
71070590|NCT00459706|141649919|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.069
71070591|NCT00459706|141649919|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.015
71070592|NCT00459706|141649920|SUPERIORITY_OR_OTHER|||||||0.652||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.652
71070593|NCT00459706|141649920|SUPERIORITY_OR_OTHER|||||||0.459||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.459
71070594|NCT00459706|141649921|SUPERIORITY_OR_OTHER|||||||0.652||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.652
71070595|NCT00459706|141649921|SUPERIORITY_OR_OTHER|||||||0.459||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.459
71070596|NCT00459706|141649922|SUPERIORITY_OR_OTHER|||||||0.652||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.652
71070597|NCT00459706|141649922|SUPERIORITY_OR_OTHER|||||||0.459||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.459
71070598|NCT00459706|141649923|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.023
71070599|NCT00459706|141649923|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||<0.001
71070600|NCT00459706|141649924|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.038
71070601|NCT00459706|141649924|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||<0.001
71070602|NCT00459706|141649925|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.018
71070603|NCT00459706|141649925|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.019
71070604|NCT00459706|141649926|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.049
71070605|NCT00459706|141649926|SUPERIORITY_OR_OTHER|||||||0.736||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.736
71070606|NCT00459706|141649927|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.033
71070607|NCT00459706|141649927|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.730
71070608|NCT00459706|141649928|SUPERIORITY_OR_OTHER|||||||0.838||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.838
71070609|NCT00459706|141649928|SUPERIORITY_OR_OTHER|||||||0.483||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.483
71070610|NCT00459706|141649929|SUPERIORITY_OR_OTHER|||||||0.466||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.466
71070611|NCT00459706|141649929|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.035
71070612|NCT00459706|141649930|SUPERIORITY_OR_OTHER|||||||0.784||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.784
71070613|NCT00459706|141649930|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.006
71070614|NCT00459706|141649931|SUPERIORITY_OR_OTHER|||||||0.843||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.843
71070615|NCT00459706|141649931|SUPERIORITY_OR_OTHER|||||||0.461||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.461
71070616|NCT00459706|141649932|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.150
71070617|NCT00459706|141649932|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.002
71070618|NCT00459706|141649933|SUPERIORITY_OR_OTHER|||||||0.934||95.0|||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.934
71070619|NCT00459706|141649933|SUPERIORITY_OR_OTHER|||||||0.656||95.0|||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.656
71070620|NCT00459706|141649934|SUPERIORITY_OR_OTHER|||||||0.934||95.0|||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.934
71070621|NCT00459706|141649934|SUPERIORITY_OR_OTHER|||||||0.656||95.0|||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.656
71070622|NCT00459706|141649935|SUPERIORITY_OR_OTHER|||||||0.934||95.0|||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.934
71070623|NCT00459706|141649935|SUPERIORITY_OR_OTHER|||||||0.656||95.0|||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.656
71113669|NCT02993822|141734911|SUPERIORITY|||||||0.387|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.387
70852850|NCT03456882|141194480|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.22||0.845|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.845
70852851|NCT03456882|141194481|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.32||0.2161|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.2161
71070624|NCT00459706|141649936|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Autoinjector group||||<0.001
71070625|NCT00459706|141649936|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||<0.001
71070626|NCT02447497|141649937|SUPERIORITY||Mean Difference (Final Values)|1.97|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|0.51|4.1|||Paired t-test|||48 hours post treatment time point. The primary analysis used a modified intent to treat population. Subjects were excluded who did not meet the treatment day baseline requirement of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen. The null hypothesis is that there is no difference in log10 CFU/cm\^2 recovery between arms.||4.10|0.51|<0.0001
71070627|NCT02447497|141649937|SUPERIORITY||Mean Difference (Final Values)|2.37|STANDARD_ERROR_OF_MEAN|0.29||0.0001|TWO_SIDED|95.0|0.6|5.75|||Paired t-test|||48 hours post treatment. The primary analysis used a modified intent to treat population. Subjects were excluded who did not meet the treatment day baseline requirement of greater than or equal to 3.0 log10 CFU/cm\^2 on the groin. The null hypothesis is that there is no difference in log10 CFU/cm\^2 recovery between arms.||5.75|0.60|0.0001
71070628|NCT02447497|141649937|SUPERIORITY||Mean Difference (Final Values)|1.51|STANDARD_ERROR_OF_MEAN|0.23||0.0001|TWO_SIDED|95.0|0.17|3.75|||Paired t-test|||72 hours post treatment. The primary analysis used a modified intent to treat population. Subjects were excluded who did not meet the treatment day baseline requirement of greater than or equal to 3.0 log10 CFUcm2 on the groin. The null hypothesis is that there is no difference in log10 CFU/cm\^2 recovery between arms.||3.75|0.17|0.0001
71070629|NCT02447497|141649937|SUPERIORITY||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|0.33||0.0001|TWO_SIDED|95.0|0.13|5.04|||Paired t-test|||72 hours post treatment. The primary analysis used a modified intent to treat population. Subjects were excluded who did not meet the treatment day baseline requirement of greater than or equal to 3.0 log10 CFUcm2 on the groin. The null hypothesis is that there is no difference in log10 CFU/cm\^2 recovery between arms.||5.04|0.13|0.0001
71113670|NCT02993822|141734911|SUPERIORITY|||||||0.025|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.025
71113671|NCT02993822|141734912|SUPERIORITY|||||||0.003|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.003
71113672|NCT02993822|141734912|SUPERIORITY|||||||0.152|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.152
71113673|NCT02993822|141734912|SUPERIORITY|||||||0.004|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.004
71113674|NCT02993822|141734913|SUPERIORITY|||||||0.1|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.100
71070630|NCT01322035|141649940|EQUIVALENCE|95% confidence limits from standard deviation of the mean were used as the equivalence.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|95% confidence limits from standard deviation||||||<0.05
71070631|NCT00732758|141649944|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||ANCOVA|adjusting for baseline 25(OH)D, race, BMI, diet vitamin D, gender, pubertal status, and sunlight exposure.||||||0.003
71070632|NCT00732758|141649945|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||t-test, 2 sided|unadjusted p-values||||||0.51
71070633|NCT00732758|141649946|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||t-test, 2 sided|||||||0.66
71070634|NCT00732758|141649947|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||t-test, 2 sided|||||||0.35
71070635|NCT01252563|141649955|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 4|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0.||||<0.001
71113675|NCT02993822|141734913|SUPERIORITY|||||||0.557|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.557
71113676|NCT02993822|141734913|SUPERIORITY|||||||0.054|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.054
71070636|NCT01252563|141649955|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 8|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0.||||<0.001
71070637|NCT01252563|141649955|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 12|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0.||||<0.001
71070638|NCT01252563|141649955|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Last Day|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0.||||<0.001
71070639|NCT01252563|141649956|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Week 4|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0.||||<0.001
71070640|NCT01252563|141649956|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 8|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0.||||<0.001
71070641|NCT01252563|141649956|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 12|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0.||||<0.001
71070642|NCT01252563|141649956|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Last Day|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0.||||<0.001
71070643|NCT01252563|141649959|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The risk factor tested was Complication. The null hypothesis was that there was no difference between participants with complication(s) and participants without complication in the frequency of treatment-related adverse events."||||<0.001
71070644|NCT01252563|141649960|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The risk factor tested was Gender. The null hypothesis was that there was no difference between male and female in the frequency of treatment-related adverse events."||||<0.001
71070645|NCT01252563|141649961|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036|||||||Chi-squared|||"The risk factor tested was angina pectoris as a complication. The null hypothesis was that there was no difference between participants with angina pectoris and participants without angina pectoris in the frequency of treatment-related adverse events."||||0.036
71113677|NCT01732510|141734916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.82||||0.015|TWO_SIDED|95.0|-16.87|-2.77|||Constrained longitudinal data analysis|||The reduction from baseline in EASI at week 12 for participants receiving MK-8226 3 mg/kg was compared to placebo (MK-8226 3 mg - Placebo). The constrained longitudinal data analysis model used variance component covariance matrix to model correlation among repeated visits, without adjustment for interaction of treatment group by visit.||-2.77|-16.87|0.015
71070646|NCT01252563|141649962|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Chi-squared|||"The risk factor tested was dyslipidaemia as a complication. The null hypothesis was that there was no difference between participants with dyslipidaemia and participants without dyslipidaemia in the frequency of treatment-related adverse events."||||0.020
71113678|NCT00313144|141734936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0|||||Paired t-test|||||||0.044
71113679|NCT00313144|141734938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0|||||Paired t-test|||||||0.009
71070647|NCT01252563|141649963|SUPERIORITY_OR_OTHER_LEGACY|||||||0.049|||||||Chi-squared|||"The risk factor tested was antihypertensive as a concomitant drug. The null hypothesis was that there was no difference between participants receiving antihypertensive and participants receiving no antihypertensive in the frequency of treatment-related adverse events."||||0.049
71070648|NCT01252563|141649964|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043|||||||Chi-squared|||"The risk factor tested was ARB as a concomitant drug. The null hypothesis was that there was no difference between participants receiving ARB and participants receiving no ARB in the frequency of treatment-related adverse events."||||0.043
71070649|NCT01252563|141649965|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The risk factor tested was diabetes mellitus as a complication. The null hypothesis was that there was no difference between participants with diabetes mellitus and participants without diabetes mellitus in the efficacy."||||<0.001
71070650|NCT01252563|141649966|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The risk factor tested was chronic kidney disease as a complication. The null hypothesis was that there was no difference between participants with chronic kidney disease and participants without chronic kidney disease in the efficacy."||||<0.001
71070651|NCT01252563|141649967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|||||||Chi-squared|||"The risk factor tested was myocardial infarction as a complication. The null hypothesis was that there was no difference between participants with myocardial infarction and participants without myocardial infarction in the efficacy."||||0.039
71070652|NCT01252563|141649968|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The risk factor tested was metabolic syndrome as a complication. The null hypothesis was that there was no difference between participants with metabolic syndrome and participants without metabolic syndrome in the efficacy."||||<0.001
71113680|NCT00313144|141734939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0|||||Paired t-test|||||||0.005
71113681|NCT00313144|141734941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0|||||Paired t-test|||||||0.006
71113682|NCT00313144|141734942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0|||||Paired t-test|||||||0.044
71113683|NCT00313144|141734943|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046||95.0|||||Paired t-test|||||||0.046
71117693|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-77.89|||<|0.001|TWO_SIDED|95.0|-92.29|-63.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-63.49|-92.29|<0.001
71070653|NCT01252563|141649969|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The risk factor tested was ambulatory SBP at baseline. The null hypothesis was that there was no association between ambulatory SBP at baseline and the number of participants who achieved the target blood pressure specified in the guidelines."||||<0.001
71070654|NCT01252563|141649971|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 4|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in home SBP from the baseline was equal to 0.||||<0.001
71070655|NCT01252563|141649971|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 8|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in home SBP from the baseline was equal to 0.||||<0.001
71070656|NCT01252563|141649971|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 12|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in home SBP from the baseline was equal to 0.||||<0.001
71070657|NCT01252563|141649971|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Last Day|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in home SBP from the baseline was equal to 0.||||<0.001
71070658|NCT01252563|141649972|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 4|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0.||||<0.001
71070659|NCT01252563|141649972|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 8|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0.||||<0.001
71070660|NCT01252563|141649972|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 12|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0.||||<0.001
71070661|NCT01252563|141649972|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Last Day|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0.||||<0.001
71070662|NCT01820572|141650004|SUPERIORITY|difference between belatacept and CNI|Difference in proportions|0.9|||||TWO_SIDED|95.0|-8.6|10.4||||||||10.4|-8.6|
71070663|NCT01820572|141650005|SUPERIORITY|difference between belatacept and CNI|Difference in Proportions|-0.4|||||TWO_SIDED|95.0|-9.9|9.0||||||||9.0|-9.9|
71070664|NCT02105246|141650027|EQUIVALENCE|This analysis compared the proportion of eligible patients who participated in cardiac rehab after referral to home-based vs. referral to center-based programs.|Risk Ratio (RR)|0.98||||0.8|TWO_SIDED||||||Chi-squared|||Null hypothesis = no difference in proportion of patients who participate in cardiac rehab after referral to home-based vs. facility-based programs||||0.80
71070665|NCT02105246|141650028|NON_INFERIORITY|This analysis compared Baseline to 3-month change in 6-minute walk test distance among subjects who participated in home-based cardiac rehab vs. subjects who participated in center-based cardiac rehab|Median Difference (Final Values)|196.0|||<|0.001|TWO_SIDED|||||This comparison was unadjusted.|Wilcoxon (Mann-Whitney)|||Null hypothesis: 3-month change in 6MWT distance is not inferior among participants enrolled in home-based vs. facility-based cardiac rehab.||||<0.001
71070666|NCT02105246|141650029|NON_INFERIORITY|This analysis compared 6-month change in 6-minute walk test distance among subjects who participated in home-based vs. center-based cardiac rehab.|Median Difference (Final Values)|159.0||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: 6-month change in 6MWT distance is not inferior among participants enrolled in home-based vs. facility-based cardiac rehab.||||0.03
71070667|NCT00387010|141650043|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.3223|TWO_SIDED|95.0|-4.64|1.54|||t-test, 2 sided|||||1.54|-4.64|0.3223
71070668|NCT02496091|141650229|OTHER||95% confidence interval (using the exact|92.7|||||TWO_SIDED|95.0|88.8|95.5||||||Only descriptive statistics The implant success rate is analyzed on an implant level (i.e. percent of successful implants) as well as subject level (i.e. percentage of subjects with no unsuccessful implants). This proportion is presented together with a 95% confidence interval (using the exact Binomial approach) and an average follow-up time.||95.5|88.8|
71070669|NCT02272842|141650235|SUPERIORITY|The study had 80% power to detect a standardized effect size of 0.22 and had 90% power to detect an effect size of 0.28. In these calculations, we assumed a loss to follow-up of 10%. Details on the samples size calculations are also presented in the previously published protocol paper.|Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.35|>|0.16|TWO_SIDED|95.0|-0.54|0.87||The main analysis was the change in cognitive scores from baseline until the end of the intervention.|t-test, 2 sided||This is the P-value for the effect on the cognitive scores.|||.87|-.54|>.16
71070670|NCT02272842|141650245|SUPERIORITY|the means were compared using Students t-test|Mean Difference (Final Values)|-0.5|||>|0.3|TWO_SIDED|95.0|-1.97|0.94||"Mean difference -0.5 points in the Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition.~95 % Confidence Interval of the mean difference: (-1.97, 0.94)"|t-test, 2 sided|||Comparing mean differences between the two study arms||0.94|-1.97|>.3
70941954|NCT00714688|141384216|SUPERIORITY_OR_OTHER||||||<|0.001||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|The ANCOVA model has been performed on ranked data. Treatment, gender \& country were used as factors and baseline value \& age were used as covariates.||Statistical analysis of change from baseline at endpoint.||||<0.001
71079372|NCT02087943|141666392|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Proportion|8.0||||0.1368|TWO_SIDED|95.0|-2.3|18.2||Adjusted treatment differences in proportions using the weighted average of the treatment differences across the stratum of baseline EASI score stratification (≤ 20, \> 20) with, CMH weights.|Cochran-Mantel-Haenszel||2-sided 95% Confidence Intervals (CI) is based on a normal approximation to the weighted average.|||18.2|-2.3|0.1368
71079373|NCT02087943|141666393|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Proportion|-1.5||||0.8589|TWO_SIDED|95.0|-18.0|14.9|||Cochran-Mantel-Haenszel||Adjusted differences in proportions was the weighted average of the treatment differences across the stratum of baseline EASI score stratification (≤ 20, \> 20) with the CMH weights.|||14.9|-18.0|0.8589
71079374|NCT02087943|141666393|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Proportion|9.9||||0.2476|TWO_SIDED|95.0|-6.7|26.6|||Cochran-Mantel-Haenszel||Adjusted differences in proportions was the weighted average of the treatment differences across the stratum of baseline EASI score stratification (≤ 20, \> 20) with the CMH weights.|||26.6|-6.7|0.2476
71070671|NCT00519428|141650254|SUPERIORITY|Hypothesis: Dual Treatment (escitalopram + bupropion) will result in greater improvement over 12 weeks than either monotherapy (i.e., two analyses: 1) dual treatment will outperform escitalopram monotherapy; 2) dual treatment will outperform bupropion monotherapy).|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|4.0||0.05|TWO_SIDED|||||"Each individual test will require the calculated p to be \< .0916 to declare that comparison to be significant. Since the hypothesis requires both comparisons to be significant, this produces an over-all alpha of .05."|Cochran-Mantel-Haenszel|||Hypothesis: Dual Treatment (escitalopram + bupropion) will result in greater improvement over 12 weeks than either monotherapy (i.e., two analyses: 1) dual treatment will outperform escitalopram monotherapy; 2) dual treatment will outperform bupropion monotherapy). Therefore each analysis will be done twice and it will be required that both analyses be significant to declare the over-all study significant.||||.05
71070672|NCT00519428|141650256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|STANDARD_DEVIATION|8.0||0.0916|TWO_SIDED|95.0||||escitalopram + bupropion vs. escitalopram: F(1,159) = 1.93, ns escitalopram + bupropion vs. bupropion: F (1,157) = 1.99, ns|ANCOVA|adjusting for baseline score and country||To test the hypothesis that escitalopram + bupropion would have superior efficacy relative to each monotherapy, the group receiving both medications was separately compared to each monotherapy group, covarying for baseline score and country||||.0916
71070673|NCT03626363|141650263|SUPERIORITY|We sought to have up to 20 participants complete each group so that we could have a statistical power of 0.89 to detect about a 4 burst per minute difference with an alpha of 0.05. We would have had sympathetic nerve data on up to 18 more of the 21 participants that we were not allowed to post-test in the spring of 2020 due to COVID-19 restrictions.|Mean Difference (Net)|-2.0||||0.51|TWO_SIDED||||||ANOVA|||Repeated measures analysis of variance with 2 groups (MBSR and SME) and 2 time points (Pre vs. Post). Outcome data reported is the change in the mean number of bursts per minute of muscle sympathetic nerve activity (MSNA) from pre to post.||||0.51
71070674|NCT03626363|141650264|SUPERIORITY|To detect a 0.5 meter per second change in carotid-to-femoral pulse wave velocity with at least 80% power with an alpha of 0.05 we should have had at least 12 participants complete measurements in each group (MBSR and SME). We fell a little short of that in the MBSR group and met the 12 participants in the SME group. The number of participants we were able to study from pre to post was limited by COVID-19 restrictions.|Mean Difference (Net)|-0.2||||0.25|TWO_SIDED||||||ANOVA|||Repeated measures analysis of variance with 2 groups (MBSR and SME) and 2 time points (Pre vs. Post). Outcome data reported is the change in carotid-to-femoral pulse wave velocity in meters per second from pre to post. We had 21 participants in the spring of 2020 that were were not allowed to bring into the laboratory for post testing during COVID-19 restrictions which led to our limited sample size.||||0.25
71070675|NCT03053063|141650289|SUPERIORITY||Percentage Difference|1.9||||0.5572|TWO_SIDED|95.0|-4.4|8.2||Difference between SEL 18 mg vs Placebo, 95% confidence interval (CI) and p-value were obtained by stratified Mantel-Haenszel method adjusting for baseline (BL) diabetes mellitus status and BL Enhanced Liver Fibrosis (ELF) score (\<11.27 vs ≥11.27).|Mantel Haenszel|||||8.2|-4.4|0.5572
71070676|NCT03053063|141650289|SUPERIORITY||Percentage Difference|0.3||||0.9272|TWO_SIDED|95.0|-6.0|6.5||Difference between SEL 6 mg vs Placebo, 95% CI and p-value were obtained by stratified Mantel-Haenszel method adjusting for BL diabetes mellitus status and BL ELF score (\<11.27 vs ≥11.27).|Mantel Haenszel|||||6.5|-6.0|0.9272
71070677|NCT03053063|141650292|SUPERIORITY||Percentage Difference|3.8||||0.285|TWO_SIDED|95.0|-3.1|10.6||Difference between SEL 18 mg vs Placebo, 95% CI and p-value were obtained by stratified Mantel-Haenszel method adjusting for BL diabetes mellitus status and BL ELF score (\<11.27 vs ≥11.27).|Mantel Haenszel|||||10.6|-3.1|0.2850
71070678|NCT03053063|141650292|SUPERIORITY||Percentage Difference|1.5||||0.6731|TWO_SIDED|95.0|-5.3|8.2||Difference between SEL 6 mg vs Placebo, 95% CI and p-value were obtained by stratified Mantel-Haenszel method adjusting for BL diabetes mellitus status and BL ELF score (\<11.27 vs ≥11.27).|Mantel Haenszel|||||8.2|-5.3|0.6731
71113684|NCT01262560|141734977|SUPERIORITY_OR_OTHER|||||||0.92||||||Due to the skewed nature of the data, median was reported instead of mean.|Wilcoxon (Mann-Whitney)|Each arm had less than the designed sample size. Therefore the statistical power was reduced (76% instead of 80%).||Null hypothesis: Manuka honey in liquid form is/not effective at reducing esophagitis-related pain, measured by mean change score from 0 to 4 weeks. A 2-sample t-test for difference of means with alpha 0.05 after adjusting for multiple comparisons (1-sided with overall alpha 0.1 before the Bonferroni adjustment) and 80% statistical power for each hypothesis test requires 45 patients per arm to detect \>= 15% relative reduction (absolute difference of mean change score of 3.1; effect size=0.53).||||0.92
70852852|NCT03456882|141194482|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.15||0.4962|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.4962
70852853|NCT03456882|141194483|SUPERIORITY|||||||0.8738||||||Significance level set to 0.05|Wilcoxon (Mann-Whitney)|||Mean AE treatment discontinuation 4 weeks. Null hypothesis: the number of adverse events occurred within 4 weeks is not different between groups||||0.8738
70852854|NCT03456882|141194483|SUPERIORITY|||||||0.7556||||||Significance level set to 0.05|Wilcoxon (Mann-Whitney)|||Mean AE treatment discontinuation 12 weeks. Null hypothesis: the number of adverse events occurred within 12 weeks is not different between groups||||0.7556
70852855|NCT03456882|141194483|SUPERIORITY|||||||0.6477||||||Significance level set to 0.05|Wilcoxon (Mann-Whitney)|||Mean AE treatment discontinuation 24 weeks. Null hypothesis: the number of adverse events occurred within 24 weeks is not different between groups||||0.6477
70852856|NCT03456882|141194483|SUPERIORITY|||||||0.6084||||||Significance level set to 0.05|Wilcoxon (Mann-Whitney)|||Mean AE treatment discontinuation 48 weeks. Null hypothesis: the number of adverse events occurred within 48 weeks is not different between groups||||0.6084
70852857|NCT00183729|141194497|SUPERIORITY||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|2.0||0.42|TWO_SIDED||||||Mixed Models Analysis|||Null: the two groups would not differ in depressive symptoms over time (ie both groups would improve equally in terms of their depressive symptoms) Power calculation: none; this was a pilot study||||0.42
71113685|NCT01262560|141734977|SUPERIORITY_OR_OTHER|||||||0.93||||||Due to the skewed nature of the data, median was reported instead of mean.|Wilcoxon (Mann-Whitney)|Each arm had less than the designed sample size. Therefore the statistical power was reduced (76% instead of 80%)||Null hypothesis: Manuka honey in lozenge form is/not effective at reducing esophagitis-related pain, measured by mean change score from 0 to 4 weeks. A 2-sample t-test for difference of means with alpha 0.05 after adjusting for multiple comparisons (1-sided with overall alpha 0.1 before the Bonferroni adjustment) and 80% statistical power for each hypothesis test requires 45 patients per arm to detect \>= 15% relative reduction (absolute difference of mean change score of 3.1; effect size=0.53).||||0.93
71113686|NCT01262560|141734978|SUPERIORITY_OR_OTHER|||||||0.87|||||||Mixed Models Analysis|Explanatory variables are reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with NRPS score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Liquid Honey vs. Supportive Care) is reported here."||||0.87
71113687|NCT01262560|141734978|SUPERIORITY|||||||0.46|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with NRPS score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Lozenge Honey vs. Supportive Care) is reported here."||||0.46
71113688|NCT01262560|141734978|SUPERIORITY|||||||0.0023|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with NRPS score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Percentage of esophagus is reported here."||||0.0023
71113689|NCT01262560|141734978|SUPERIORITY|||||||0.0025|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with NRPS score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Opioid use is reported here."||||0.0025
70939119|NCT05361304|141379145|NON_INFERIORITY||Least square Mean (LSM) Difference|0.27|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|95.0|-0.46|1.01|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|LSM difference was calculated as Senofilcon A contact lenses made with a novel manufacturing technology minus Senofilcon A contact lenses made with the current manufacturing technology|It was calculated using a 2 independent sample means t-test with a 2-sided type I error rate of 5% with at least 80% statistical power, that 100 subjects were required to test for non-inferiority of the Senofilcon A contact lenses made with a novel manufacturing technology compared to the Senofilcon A contact lenses made with the current manufacturing technology.||1.010|-0.460|
70939120|NCT05361304|141379146|NON_INFERIORITY||LSM Difference|4.0|STANDARD_ERROR_OF_MEAN|4.06|||TWO_SIDED|95.0|-4.1|12.0|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|LSM difference was calculated as Senofilcon A contact lenses made with a novel manufacturing technology minus Senofilcon A contact lenses made with the current manufacturing technology|||12.0|-4.1|
70939121|NCT05361304|141379147|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the confidence interval of the mean difference between Senofilcon A contact lenses made with a novel manufacturing technology and Senofilcon A contact lenses made with the current manufacturing technology is greater than -5.|LSM Differences|-0.3|STANDARD_ERROR_OF_MEAN|3.44|||TWO_SIDED|95.0|-7.1|6.5|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|LSM difference was calculated as Senofilcon A contact lenses made with a novel manufacturing technology minus Senofilcon A contact lenses made with the current manufacturing technology|||6.5|-7.1|
70939122|NCT01877720|141379170|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||||||<0.001
71113690|NCT01262560|141734978|SUPERIORITY||||||<|0.0001||||||Each explanatory variable is reported separately.|Mixed Models Analysis|||"A linear fixed effects model using maximum likelihood estimation was run with NRPS score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Time is reported here."||||<0.0001
70852858|NCT00183729|141194499|SUPERIORITY|(no comments)|Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|7.0||0.06|TWO_SIDED||||||Mixed Models Analysis|||Null hypothesis: functional recovery would be the same in both groups. Power calculation: none. This was a pilot study.||||0.06
70852859|NCT03512457|141194500|SUPERIORITY|Chi-square||||||0.12||||||P-value of \<0.05 is the threshold for statistical significance. The hypothesis was that more women randomized to the intensive intervention would perform skin self-examination.|Chi-squared|Chi-Squared is equal to 1.58, with a P-Value of 0.12.||change from baseline to 3 months in performance of skin self-examination Parallel: response rate||||0.12
70852860|NCT03512457|141194501|SUPERIORITY|Types of lesions in the following categories: Benign nevus, seborrheic keratosis, lentigo, dermatofibroma, atypical nevus. melanoma|||||<|0.05|||||||Chi-squared|||results of skin clinical examination and biopsy of clinically suspicious moles||||<0.05
70852861|NCT00535288|141194577|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.2|||<|0.01|TWO_SIDED|95.0|-2.2|-0.2||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.2|-2.2|<0.01
70939123|NCT01877720|141379171|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Paired t-test|||||||0.001
70939124|NCT01877720|141379172|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||Paired t-test|||||||0.74
70939125|NCT01877720|141379173|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Paired t-test|||||||0.003
71070679|NCT03053063|141650294|SUPERIORITY||Percentage Difference|-1.7||||0.365|TWO_SIDED|95.0|-5.5|2.0||Difference between SEL 18 mg vs Placebo, 95% CI and p-value were obtained by stratified Mantel-Haenszel method adjusting for BL diabetes mellitus status and BL ELF score (\<11.27 vs ≥11.27).|Mantel Haenszel|||||2.0|-5.5|0.3650
71070680|NCT03053063|141650294|SUPERIORITY||Percentage Difference|-0.4||||0.8557|TWO_SIDED|95.0|-4.3|3.6||Difference between SEL 6 mg vs Placebo, 95% CI and p-value were obtained by stratified Mantel-Haenszel method adjusting for BL diabetes mellitus status and BL ELF score (\<11.27 vs ≥11.27).|Mantel Haenszel|||||3.6|-4.3|0.8557
71070681|NCT02100670|141650313|SUPERIORITY_OR_OTHER||Difference of LS mean|-9.23||||0.4144|TWO_SIDED|95.0|-31.45|12.98||P-value from multiple comparisons using t-test in Proc Mixed|ANCOVA|Least squares (LS) means from mixed model analysis of covariance with treatment, site as fixed effects, pain intensity at baseline as a covariates.|Difference of LS mean of first named treatment minus second named treatment. Lower values of LS mean favours a better response because of lower pain intensity over time. 95% Confidence intervals of difference between LS means.|||12.98|-31.45|0.4144
71070682|NCT02100670|141650314|SUPERIORITY_OR_OTHER||LS mean difference|1.58||||0.8761|TWO_SIDED|95.0|-18.34|21.5||P-value from multiple comparisons using t-test in Proc Mixed|ANCOVA|Least squares (LS) means from mixed model analysis of covariance with treatment, site as fixed effects, pain intensity at baseline as a covariates.|Difference of LS mean of first named treatment minus second named treatment. Lower values of LS mean favours a better response because of lower pain intensity over time. 95% Confidence intervals of difference between LS means.|||21.50|-18.34|0.8761
71070683|NCT02100670|141650314|SUPERIORITY_OR_OTHER||LS mean difference|2.61||||0.8164|TWO_SIDED|95.0|-19.46|24.67||P-value from multiple comparisons using t-test in Proc Mixed|ANCOVA|Least squares (LS) means from mixed model analysis of covariance with treatment, site as fixed effects, pain intensity at baseline as a covariates.|Difference of LS mean of first named treatment minus second named treatment. Lower values of LS mean favours a better response because of lower pain intensity over time. 95% Confidence intervals of difference between LS means.|||24.67|-19.46|0.8164
71070684|NCT02100670|141650314|SUPERIORITY_OR_OTHER||LS mean difference|1.03||||0.9279|TWO_SIDED|95.0|-21.27|23.33||P-value from multiple comparisons using t-test in Proc Mixed|ANCOVA|Least squares (LS) means from mixed model analysis of covariance with treatment, site as fixed effects, pain intensity at baseline as a covariates.|Difference of LS mean of first named treatment minus second named treatment. Lower values of LS mean favours a better response because of lower pain intensity over time. 95% Confidence intervals of difference between LS means.|||23.33|-21.27|0.9279
71070685|NCT02100670|141650314|SUPERIORITY_OR_OTHER||LS mean difference|-10.81||||0.3442|TWO_SIDED|95.0|-33.26|11.64||P-value from multiple comparisons using t-test in Proc Mixed.|ANCOVA|Least squares (LS) means from mixed model analysis of covariance with treatment, site as fixed effects, pain intensity at baseline as a covariates.|Difference of LS mean of first named treatment minus second named treatment. Lower values of LS mean favours a better response because of lower pain intensity over time. 95% Confidence intervals of difference between LS means.|||11.64|-33.26|0.3442
71070686|NCT02100670|141650319|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.1||||0.5404|TWO_SIDED|95.0|0.81|1.48||P-value from chi-square test of survival analysis|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||1.48|0.81|0.5404
71070687|NCT02100670|141650319|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|0.9||||0.4639|TWO_SIDED|95.0|0.67|1.2||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||1.20|0.67|0.4639
71070688|NCT02100670|141650319|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.09||||0.5118|TWO_SIDED|95.0|0.84|1.43||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||1.43|0.84|0.5118
70939126|NCT01877720|141379174|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Paired t-test|||||||0.002
70939127|NCT01877720|141379175|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Paired t-test|||||||0.003
70939128|NCT01877720|141379176|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Paired t-test|||||||0.012
70939129|NCT01877720|141379177|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Paired t-test|||||||0.67
70939130|NCT01877720|141379178|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon signed-rank test|||||||<0.001
70939131|NCT01877720|141379179|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon signed-rank test|||||||<0.001
70939132|NCT02068352|141379191|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|11.93||||0.069|TWO_SIDED|95.0|-0.08|23.95||P-value was derived using Cochran-Mantel-Haenszel (CMH) test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||23.95|-0.08|0.0690
70939133|NCT02068352|141379191|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|18.23||||0.0165|TWO_SIDED|95.0|4.99|31.46||P-value was derived using CMH test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||31.46|4.99|0.0165
70939134|NCT02068352|141379191|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|12.3||||0.0617|TWO_SIDED|95.0|0.06|24.53||P-value was derived using CMH test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||24.53|0.06|0.0617
71070689|NCT02100670|141650320|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|0.93||||0.6918|TWO_SIDED|95.0|0.67|1.31||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||1.31|0.67|0.6918
71070690|NCT02100670|141650320|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.23||||0.2389|TWO_SIDED|95.0|0.87|1.73||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||1.73|0.87|0.2389
71070691|NCT02100670|141650320|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.0||||0.9817|TWO_SIDED|95.0|0.74|1.37||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||1.37|0.74|0.9817
71070692|NCT02100670|141650321|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.06||||0.7003|TWO_SIDED|95.0|0.79|1.43||P-value from chi-square test of survival analysis|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to cooling sensation. The 95% confidence intervals of cox proportional hazard ratio.|||1.43|0.79|0.7003
70852862|NCT00535288|141194577|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.7|||<|0.01|TWO_SIDED|95.0|-2.7|-0.7||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.7|-2.7|<0.01
70939135|NCT02068352|141379192|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.47||||0.0128|TWO_SIDED|95.0|-0.84|-0.1|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, and interaction of treatment by visit as terms, Baseline score as a covariate.||||-0.10|-0.84|0.0128
70939136|NCT02068352|141379192|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46||||0.0134|TWO_SIDED|95.0|-0.81|-0.1|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||-0.10|-0.81|0.0134
70939137|NCT02068352|141379193|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.0048|TWO_SIDED|95.0|-0.85|-0.16|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||-0.16|-0.85|0.0048
70939138|NCT02068352|141379193|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.0045|TWO_SIDED|95.0|-0.84|-0.16|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||-0.16|-0.84|0.0045
70939139|NCT02068352|141379195|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.26||||0.4173|TWO_SIDED|95.0|-8.99|21.52||P-value was derived using CMH test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||21.52|-8.99|0.4173
70939140|NCT02068352|141379195|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.47||||0.4895|TWO_SIDED|95.0|-9.43|20.36||P-value was derived using CMH test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||20.36|-9.43|0.4895
70939141|NCT02068352|141379195|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.19||||0.2677|TWO_SIDED|95.0|-6.74|25.12||P-value was derived using CMH test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||25.12|-6.74|0.2677
71070693|NCT02100670|141650321|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.01||||0.9565|TWO_SIDED|95.0|0.75|1.35||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to cooling sensation. The 95% confidence intervals of cox proportional hazard ratio.|||1.35|0.75|0.9565
71070694|NCT02100670|141650321|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.07||||0.6216|TWO_SIDED|95.0|0.82|1.4||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to cooling sensation. The 95% confidence intervals of cox proportional hazard ratio.|||1.40|0.82|0.6216
70939142|NCT02068352|141379195|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.12||||0.2319|TWO_SIDED|95.0|-5.63|25.87||P-value was derived using CMH test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||25.87|-5.63|0.2319
70939143|NCT02068352|141379196|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.11||||0.3213|TWO_SIDED|95.0|-3.33|1.11|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||1.11|-3.33|0.3213
71070695|NCT02100670|141650325|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|2.43||||0.0408|TWO_SIDED|95.0|1.04|5.7||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to complete pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||5.70|1.04|0.0408
70939144|NCT02068352|141379196|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.09||||0.0594|TWO_SIDED|95.0|-4.27|0.08|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||0.08|-4.27|0.0594
70939145|NCT02068352|141379196|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.03||||0.396|TWO_SIDED|95.0|-3.43|1.37|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||1.37|-3.43|0.396
70939146|NCT02068352|141379196|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9||||0.1135|TWO_SIDED|95.0|-4.26|0.46|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||0.46|-4.26|0.1135
70939147|NCT02068352|141379197|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.49||||0.1703|TWO_SIDED|95.0|-3.63|0.65|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||0.65|-3.63|0.1703
71070696|NCT02100670|141650325|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.31||||0.4507|TWO_SIDED|95.0|0.65|2.65||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to complete pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||2.65|0.65|0.4507
71070697|NCT02100670|141650325|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.38||||0.315|TWO_SIDED|95.0|0.73|2.61||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to complete pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||2.61|0.73|0.3150
71070698|NCT01953874|141650347|OTHER|The primary analysis was based on the Wilcoxon-Mann-Whitney test and therefore the power calculation was approximated using the approach of Tang.||||||0.916|||||||Wilcoxon (Mann-Whitney)|||The primary endpoint was a composite measure of global rank order response based on survival time, freedom from CV hospitalization, and improvement in functional capacity measured by percent change in 6MWD from baseline to 6 months. The plan was to randomize up to 215 subjects. However, due to safety issues observed in SERVE-HF, randomization was stopped at 126 subjects.||||0.916
71070699|NCT03339726|141650367|SUPERIORITY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.22||0.3|TWO_SIDED|95.0|-0.205|0.662||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.662|-0.205|0.300
70939148|NCT02068352|141379197|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.56||||0.0176|TWO_SIDED|95.0|-4.67|-0.45|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||-0.45|-4.67|0.0176
70939149|NCT02068352|141379197|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.41||||0.2381|TWO_SIDED|95.0|-3.78|0.95|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||0.95|-3.78|0.2381
70939150|NCT02068352|141379197|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.36||||0.047|TWO_SIDED|95.0|-4.68|-0.03|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||-0.03|-4.68|0.047
71070700|NCT03339726|141650367|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.222||0.569|TWO_SIDED|95.0|-0.311|0.564||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.564|-0.311|0.569
71070701|NCT03339726|141650367|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.22||0.645|TWO_SIDED|95.0|-0.537|0.333||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.333|-0.537|0.645
70939151|NCT02068352|141379198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.8196|TWO_SIDED|95.0|-13.5|10.7|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||10.7|-13.5|0.8196
70939152|NCT02068352|141379198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.83||||0.0503|TWO_SIDED|95.0|-23.69|0.02|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||0.02|-23.69|0.0503
70939153|NCT02068352|141379198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.68||||0.5902|TWO_SIDED|95.0|-17.22|9.85|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||9.85|-17.22|0.5902
70939154|NCT02068352|141379198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.42||||0.0482|TWO_SIDED|95.0|-26.73|-0.11|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||-0.11|-26.73|0.0482
70939155|NCT02068352|141379199|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.8633|TWO_SIDED|95.0|-12.48|10.48|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||10.48|-12.48|0.8633
70939156|NCT02068352|141379199|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.54||||0.0452|TWO_SIDED|95.0|-22.83|-0.25|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||-0.25|-22.83|0.0452
70939157|NCT02068352|141379199|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.73||||0.6746|TWO_SIDED|95.0|-15.58|10.12|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||10.12|-15.58|0.6746
70939158|NCT02068352|141379199|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.05||||0.0432|TWO_SIDED|95.0|-25.69|-0.4|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||-0.4|-25.69|0.0432
70939159|NCT00267956|141379232|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The study is designed to maintain a Type I error of 0.05 or less for the primary analysis|Cochran-Mantel-Haenszel (CMH) chi-square|Stratified by subject's prior anti-Tumor Necrosis Factor (TNF) exposure status (Yes/No).||Hypothesis: No difference between ustekinumab x 4 and placebo at a significant level of 0.05. Sample Size and power: With 70 partcipants in each treatment group, 5000 repetitions. Assuming a 20% ACR20 response in placebo participants regardless of prior anti-TNF exposure and a 35% ACR 20 and 45% ACR20 response in ustekinumab group for participants who had prior anti-TNF exposure, and who had no prior anti-TNF exposures, the power to detect the treatment difference is 0.85.||||<0.001
70939160|NCT00267956|141379233|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||No multiplicity adjustment was made and nominal p-value was reported.|Cochran-Mantel-Haenszel (CMH) chi-square|Stratified by participant's prior anti-TNF exposure status (Yes/No).||Hypothesis: No difference between Group II and Group I at a significant level of 0.05.||||0.004
71070702|NCT03339726|141650368|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.26||0.346|TWO_SIDED|95.0|-0.267|0.759||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.759|-0.267|0.346
71070703|NCT03339726|141650368|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.263||0.938|TWO_SIDED|95.0|-0.498|0.539||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.539|-0.498|0.938
71070704|NCT03339726|141650368|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.261||0.389|TWO_SIDED|95.0|-0.741|0.289||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.289|-0.741|0.389
71070705|NCT03339726|141650369|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.23||0.607|TWO_SIDED|95.0|-0.33|0.57|||ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.57|-0.33|0.607
71070706|NCT03339726|141650369|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.232||0.085|TWO_SIDED|95.0|-0.06|0.86||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.86|-0.06|0.085
71070707|NCT03339726|141650369|SUPERIORITY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.23||0.22|TWO_SIDED|95.0|-0.17|0.74||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.74|-0.17|0.220
71070708|NCT03339726|141650370|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.271||0.633|TWO_SIDED|95.0|-0.4|0.66||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.66|-0.40|0.633
71070709|NCT03339726|141650370|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.273||0.952|TWO_SIDED|95.0|-0.52|0.56||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.56|-0.52|0.952
71070710|NCT03339726|141650370|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.272||0.678|TWO_SIDED|95.0|-0.65|0.42||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.42|-0.65|0.678
71070711|NCT03339726|141650371|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.25||0.126|TWO_SIDED|95.0|-0.11|0.88||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.88|-0.11|0.126
71070712|NCT03339726|141650371|SUPERIORITY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.253||0.27|TWO_SIDED|95.0|-0.22|0.78||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.78|-0.22|0.270
71113691|NCT01262560|141734979|SUPERIORITY_OR_OTHER|||||||0.7|||||||Mixed Models Analysis|Explanatory variables are reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with dysphagia score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. Treatment (Liquid Honey vs. Supportive Care) is reported here."||||0.70
71113692|NCT01262560|141734979|SUPERIORITY_OR_OTHER|||||||0.71|||||||Mixed Models Analysis|Explanatory variables are reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with dysphagia score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Lozenge Honey vs. Supportive Care) is reported here."||||0.71
70939161|NCT00267956|141379234|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||No multiplicity adjustment was made and nominal p-value was reported.|Cochran-Mantel-Haenszel (CMH) chi-square|Stratified by participant's prior anti-TNF exposure status (Yes/No).||Hypothesis: No difference between ustekinumab x 4 and placebo at a significant level of 0.05.||||0.005
70939162|NCT00267956|141379235|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No multiplicity adjustment was made and nominal p-value was reported.|ANOVA on van der Waerden normal scores|Treatment and prior anti-TNF exposure (Yes/No) as factors in the model.||Hypothesis: No difference between ustekinumab x 4 and placebo at a significant level of 0.05.||||<0.001
71070713|NCT03339726|141650371|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.251||0.676|TWO_SIDED|95.0|-0.6|0.39||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.39|-0.60|0.676
70939163|NCT00267956|141379236|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No multiplicity adjustment was made and nominal p-value was reported.|Cochran-Mantel-Haenszel (CMH) chi-square|Stratified by participant's prior anti-TNF exposure status (Yes/No).||Hypothesis: No difference between ustekinumab x 4 and placebo at a significant level of 0.05.||||<0.001
70939164|NCT00267956|141379237|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No multiplicity adjustment was made and nominal p-value was reported.|ANOVA on van der Waerden normal scores|Treatment and prior anti-TNF exposure (Yes/No) as factors in the model.||Hypothesis: No difference between ustekinumab x 4 and placebo at asignificant level of 0.05.||||<0.001
71070714|NCT03339726|141650372|SUPERIORITY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.264||0.421|TWO_SIDED|95.0|-0.31|0.73||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.73|-0.31|0.421
71070715|NCT03339726|141650372|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.266||0.97|TWO_SIDED|95.0|-0.54|0.52||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.52|-0.54|0.970
71070716|NCT03339726|141650372|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.265||0.401|TWO_SIDED|95.0|-0.74|0.3||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.30|-0.74|0.401
71070717|NCT03339726|141650373|SUPERIORITY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.272||0.257|TWO_SIDED|95.0|-0.23|0.85||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.85|-0.23|0.257
71070718|NCT03339726|141650373|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.275||0.877|TWO_SIDED|95.0|-0.5|0.58||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.58|-0.50|0.877
71070719|NCT03339726|141650373|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.273||0.329|TWO_SIDED|95.0|-0.8|0.27||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.27|-0.80|0.329
71070720|NCT03339726|141650374|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.298||0.469|TWO_SIDED|95.0|-0.37|0.8||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.80|-0.37|0.469
71070721|NCT03339726|141650374|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.301||0.924|TWO_SIDED|95.0|-0.57|0.62||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.62|-0.57|0.924
71113693|NCT01262560|141734979|SUPERIORITY|||||||0.0002|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with dysphagia score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Percentage of esophagus is reported here."||||0.0002
71113694|NCT01262560|141734979|SUPERIORITY|||||||0.0051|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with dysphagia score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Opioid use is reported here."||||0.0051
71113695|NCT01262560|141734979|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with dysphagia score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Time is reported here."||||<0.0001
71113696|NCT01262560|141734980|SUPERIORITY_OR_OTHER|||||||0.086|||||||Mixed Models Analysis|Explanatory variables are reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC global health status (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Liquid Honey vs. Supportive Care) is reported here."||||0.086
71113697|NCT01262560|141734980|SUPERIORITY_OR_OTHER|||||||0.2|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC global health status (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Lozenge Honey vs. Supportive Care) is reported here."||||0.20
70852863|NCT00535288|141194577|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.4|||<|0.01|TWO_SIDED|95.0|-2.4|-0.4||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.4|-2.4|<0.01
70939165|NCT01263223|141379238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7|||<|0.0001|TWO_SIDED|95.0|7.4|12.0||P-value is for the Mean Change in ABPM heart rate.|Mixed Models Analysis|||||12.0|7.4|<0.0001
71070722|NCT03339726|141650374|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.299||0.532|TWO_SIDED|95.0|-0.78|0.4||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.40|-0.78|0.532
71070723|NCT03339726|141650375|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.309||0.579|TWO_SIDED|95.0|-0.78|0.44||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.44|-0.78|0.579
71070724|NCT03339726|141650375|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.312||0.394|TWO_SIDED|95.0|-0.88|0.35||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.35|-0.88|0.394
71070725|NCT03339726|141650375|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.31||0.76|TWO_SIDED|95.0|-0.71|0.52||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.52|-0.71|0.760
71070726|NCT03339726|141650376|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.218||0.616|TWO_SIDED|95.0|-0.32|0.539||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.539|-0.320|0.616
71070727|NCT03339726|141650376|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.22||0.734|TWO_SIDED|95.0|-0.359|0.508||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.508|-0.359|0.734
71070728|NCT03339726|141650376|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.218||0.874|TWO_SIDED|95.0|-0.465|0.395||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.395|-0.465|0.874
71070729|NCT03339726|141650377|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.23||0.75|TWO_SIDED|95.0|-0.53|0.38||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.38|-0.53|0.750
71070730|NCT03339726|141650377|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.232||0.39|TWO_SIDED|95.0|-0.26|0.66||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.66|-0.26|0.390
71070731|NCT03339726|141650377|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.23||0.236|TWO_SIDED|95.0|-0.18|0.73||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.73|-0.18|0.236
71070732|NCT03339726|141650378|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.267||0.707|TWO_SIDED|95.0|-0.63|0.43||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.43|-0.63|0.707
71070733|NCT03339726|141650378|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.269||0.839|TWO_SIDED|95.0|-0.59|0.48||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.48|-0.59|0.839
71070734|NCT03339726|141650378|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.267||0.864|TWO_SIDED|95.0|-0.48|0.57||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.57|-0.48|0.864
70939166|NCT01263223|141379238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.4|||<|0.0001|TWO_SIDED|95.0|17.9|30.9||P-value is for the Maximum Change in ABPM heart rate.|Mixed Models Analysis|||||30.9|17.9|<0.0001
70939167|NCT01263223|141379239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3|||<|0.0001|TWO_SIDED|95.0|3.9|8.8||P-value is for the Mean Change in ABPM systolic BP.|Mixed Models Analysis|||||8.8|3.9|<0.0001
71113698|NCT01262560|141734980|SUPERIORITY|||||||0.44|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC global health status (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Percentage of esophagus is reported here."||||0.44
71113699|NCT01262560|141734980|SUPERIORITY|||||||0.0066|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC global health status (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Opioid use is reported here."||||0.0066
71113700|NCT01262560|141734980|SUPERIORITY|||||||0.36|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC global health status (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Time is reported here."||||0.36
71113701|NCT01262560|141734980|SUPERIORITY_OR_OTHER|||||||0.94|||||||Mixed Models Analysis|Explanatory variables are reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC pain score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Liquid Honey vs. Supportive Care) is reported here."||||0.94
71113702|NCT01262560|141734980|SUPERIORITY_OR_OTHER|||||||0.58|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC pain score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Lozenge Honey vs. Supportive Care) is reported here."||||0.58
71113703|NCT01262560|141734980|SUPERIORITY|||||||0.28|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC pain score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Percentage of esophagus is reported here."||||0.28
71113704|NCT01262560|141734980|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each exploratory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC pain score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Opioid use is reported here."||||<0.0001
71113705|NCT01262560|141734980|SUPERIORITY|||||||0.28|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC pain score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Time is reported here."||||0.28
71113706|NCT01262560|141734981|SUPERIORITY_OR_OTHER|||||||0.06||||||Significance level = 0.05|Fisher Exact|||||||0.06
70939168|NCT01263223|141379239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1||||0.0025|TWO_SIDED|95.0|2.6|11.6||P-value is for the Maximum Change in ABPM systolic BP.|Mixed Models Analysis|||||11.6|2.6|0.0025
71113707|NCT01262560|141734981|SUPERIORITY_OR_OTHER|||||||0.31||||||Significance level = 0.05|Fisher Exact|||||||0.31
71113708|NCT01262560|141734982|SUPERIORITY_OR_OTHER|||||||0.53||||||significance level = 0.05|t-test, 2 sided|||||||0.53
71113709|NCT01262560|141734982|SUPERIORITY_OR_OTHER|||||||0.88||||||significance level = 0.05|t-test, 2 sided|||||||0.88
70939169|NCT01263223|141379239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.51|||<|0.0001|TWO_SIDED|95.0|3.81|7.21||P-value is for the Mean Change in ABPM diastolic BP.|Mixed Models Analysis|||||7.21|3.81|<0.0001
71113710|NCT01262560|141734983|SUPERIORITY_OR_OTHER|||||||0.2|||||||t-test, 2 sided|||||||0.20
71113711|NCT01262560|141734983|SUPERIORITY_OR_OTHER|||||||0.28|||||||t-test, 2 sided|||||||0.28
71113712|NCT01262560|141734986|SUPERIORITY_OR_OTHER|||||||0.39|||||||Wilcoxon (Mann-Whitney)|Because data was not normally distributed, this test was used instead of the t-test.||Each experimental arm was compared to the control arm (i.e. 2 comparisons) using two-sample t-tests. Forty-five patients with data in each arm, provides 80% power to detect an effect size (in standard deviation units) of 0.60 and 90% power to detect an effect size of 0.69 using a two-sided T-test with a Bonferroni adjusted significance level of 0.05 for each comparison (overall alpha 0.10). Due to the lack of prior data on the PRO-CTCAE, moderate effect sizes were used.||||0.39
71070735|NCT03339726|141650379|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.255||0.794|TWO_SIDED|95.0|-0.44|0.57||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.57|-0.44|0.794
71070736|NCT03339726|141650379|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.257||0.628|TWO_SIDED|95.0|-0.38|0.63||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.63|-0.38|0.628
71070737|NCT03339726|141650379|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.255||0.82|TWO_SIDED|95.0|-0.45|0.56||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.56|-0.45|0.820
71070738|NCT03339726|141650380|SUPERIORITY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.266||0.33|TWO_SIDED|95.0|-0.27|0.79||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.79|-0.27|0.330
71070739|NCT03339726|141650380|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.269||0.631|TWO_SIDED|95.0|-0.4|0.66||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.66|-0.40|0.631
71070740|NCT03339726|141650380|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.266||0.625|TWO_SIDED|95.0|-0.66|0.4||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.40|-0.66|0.625
71070741|NCT03339726|141650381|SUPERIORITY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.275||0.24|TWO_SIDED|95.0|-0.22|0.87||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.87|-0.22|0.240
71070742|NCT03339726|141650381|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.278||0.865|TWO_SIDED|95.0|-0.5|0.6||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.60|-0.50|0.865
71070743|NCT03339726|141650381|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.275||0.316|TWO_SIDED|95.0|-0.82|0.27||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.27|-0.82|0.316
71070744|NCT03339726|141650382|SUPERIORITY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.284||0.529|TWO_SIDED|95.0|-0.38|0.74||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.74|-0.38|0.529
71070745|NCT03339726|141650382|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.287||0.997|TWO_SIDED|95.0|-0.56|0.57||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.57|-0.56|0.997
71070746|NCT03339726|141650382|SUPERIORITY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.285||0.532|TWO_SIDED|95.0|-0.74|0.38||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.38|-0.74|0.532
71070747|NCT03339726|141650383|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.309||0.468|TWO_SIDED|95.0|-0.83|0.38||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.38|-0.83|0.468
71070748|NCT03339726|141650383|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.312||0.218|TWO_SIDED|95.0|-1.0|0.23||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.23|-1.00|0.218
71113713|NCT01262560|141734986|SUPERIORITY_OR_OTHER|||||||0.69|||||||Wilcoxon (Mann-Whitney)|Because data was not normally distributed, this test was used instead of the t-test.||Each experimental arm was compared to the control arm (i.e. 2 comparisons) using two-sample t-tests. Forty-five patients with data in each arm, provides 80% power to detect an effect size (in standard deviation units) of 0.60 and 90% power to detect an effect size of 0.69 using a two-sided T-test with a Bonferroni adjusted significance level of 0.05 for each comparison (overall alpha 0.10). Due to the lack of prior data on the PRO-CTCAE, moderate effect sizes were used.||||0.69
71117694|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-71.65|||<|0.001|TWO_SIDED|95.0|-86.71|-56.58||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-56.58|-86.71|<0.001
71117695|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-72.87|||<|0.001|TWO_SIDED|95.0|-88.06|-57.68||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-57.68|-88.06|<0.001
71070749|NCT03339726|141650383|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.309||0.604|TWO_SIDED|95.0|-0.77|0.45||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.45|-0.77|0.604
71070750|NCT01246349|141650394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.616|STANDARD_ERROR_OF_MEAN|7.373||0.24|TWO_SIDED|95.0|-5.871|23.103|||Regression, Linear|||Published results comprise baseline and follow-up means and standard deviations for both the MI and control group (reported above), as well as the absolute attributable effect of intervention (i.e., the difference in self-efficacy \[WEL\] change between the treatment and control groups from baseline to a 6 month follow-up).||23.103|-5.871|0.24
71070751|NCT01246349|141650395|SUPERIORITY_OR_OTHER|||||||0.56|||||||Regression, Linear|||Results published comprise baseline and follow-up BMI z-score means and standard deviations for both the MI and control groups (reported above), as well as the attributable effect of intervention (i.e., the difference in BMI change between the treatment and control groups from baseline to a 6-month follow-up)||||0.56
71070752|NCT01246349|141650396|SUPERIORITY_OR_OTHER|||||||0.09|||||||Regression, Linear|||Results published comprise baseline and follow-up means and standard deviations for both the MI and control group (reported above), as well as the attributable effect of intervention (i.e., the difference in waist circumference change between the treatment and control groups from baseline to a 6-month follow-up).||||0.09
71070753|NCT01246349|141650398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|STANDARD_ERROR_OF_MEAN|1.265||0.88|TWO_SIDED|95.0|-2.301|2.668|||Regression, Linear|||"Based on previous research , baseline CDSS means were expected between 5 - 6.5 with a SD of 3 - 4. It was hypothesized that an attributable effect of 1.5 would be detected.~Published results comprise baseline and follow-up means and standard deviations for both the MI and control group (reported above), as well as the absolute attributable effect of intervention (i.e., the difference in self-efficacy \[CDSS\] change between the treatment and control groups from baseline to a 6 month follow-up)."||2.668|-2.301|0.88
71113714|NCT00673231|141735005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.0726|<|0.0001|TWO_SIDED|95.0|-0.59|-0.31||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided)||-0.31|-0.59|<0.0001
71113715|NCT00673231|141735005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.0718|<|0.0001|TWO_SIDED|95.0|-0.66|-0.38||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided)||-0.38|-0.66|<0.0001
71070754|NCT04934189|141650402|OTHER||Mean Difference (Final Values)|0.295|STANDARD_DEVIATION|1.184||0.08|ONE_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month) mean was statistically different from the baseline mean.||||.08
71070755|NCT04934189|141650403|OTHER||Mean Difference (Net)|0.417|STANDARD_DEVIATION|0.89||0.005|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month follow-up mean) was statistically different from the baseline mean.||||.005
71070756|NCT04934189|141650405|OTHER||Mean Difference (Net)|-0.103|STANDARD_DEVIATION|2.5||0.4|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month) mean was statistically different from the baseline mean.||||0.40
71070757|NCT04934189|141650406|OTHER||Mean Difference (Net)|-0.01|STANDARD_DEVIATION|2.08||0.49|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month follow-up) mean was statistically different from the baseline mean.||||.49
71070758|NCT04934189|141650408|OTHER||Mean Difference (Net)|0.195|STANDARD_DEVIATION|1.41||0.21|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month) mean was statistically different from the baseline mean.||||.21
71070759|NCT04934189|141650409|OTHER||Mean Difference (Net)|0.019|STANDARD_DEVIATION|1.43||0.47|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean was statistically different from the baseline mean.||||.47
71070760|NCT04934189|141650411|OTHER||Mean Difference (Net)|0.175|STANDARD_DEVIATION|1.02||0.16|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month) mean was statistically different from the baseline mean.||||.16
70939170|NCT01263223|141379239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.66||||0.002|TWO_SIDED|95.0|2.13|9.2||P-value is for the Maximum Change in ABPM diastolic BP.|Mixed Models Analysis|||||9.20|2.13|0.0020
70939171|NCT01263223|141379240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9||||0.0224|TWO_SIDED|95.0|0.418|5.38||P-value is for the Mean Change in ABPM systolic BP.|Mixed Models Analysis|||||5.38|0.418|0.0224
70939172|NCT01263223|141379240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7||||0.2453|TWO_SIDED|95.0|-1.88|7.29||P-value is for the Maximum Change in ABPM systolic BP.|Mixed Models Analysis|||||7.29|-1.88|0.2453
71070761|NCT04934189|141650412|OTHER||Mean Difference (Net)|0.0481|STANDARD_DEVIATION|0.926||0.38|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean was statistically different from the baseline mean.||||.38
71070762|NCT04934189|141650414|OTHER||Mean Difference (Net)|0.179|STANDARD_DEVIATION|2.73||0.35|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month) mean was statistically different from the baseline mean.||||.35
71070763|NCT04934189|141650415|OTHER||Mean Difference (Net)|-0.335|STANDARD_DEVIATION|2.05||0.17|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean was statistically different from the baseline mean.||||.17
71070764|NCT04934189|141650419|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month followup) mean for gender nonaffirmation was statistically different from the baseline mean.|t-test|2.18||||0.02|ONE_SIDED|||||A priori threshold for statistical significance was \<.05|t-test, 1 sided|||||||.02
71070765|NCT04934189|141650419|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month followup) mean for internalized transphobia was statistically different from the baseline mean.|t-test|1.29||||0.1|ONE_SIDED|||||A priori threshold for statistical significant was p \<.05|t-test, 1 sided|||||||.10
71070766|NCT04934189|141650419|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month followup) mean for identity nondisclosure was statistically different from the baseline mean.|t-test|0.17||||0.43|ONE_SIDED|||||A priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.43
71070767|NCT04934189|141650419|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month followup) mean for negative expectations was statistically different from the baseline mean.|t-test|-0.68||||0.25|ONE_SIDED|||||A priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.25
71070768|NCT04934189|141650419|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month followup) mean for community connection was statistically different from the baseline mean.|t-test|-0.36||||0.36|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.36
71070769|NCT04934189|141650419|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month followup) mean for pride was statistically different from the baseline mean.|t-test|-0.09||||0.47|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.47
71070770|NCT04934189|141650420|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean for gender nonaffirmation was statistically different from the baseline mean.|t-test|3.76|||<|0.001|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided||||"A series of one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean was statistically different from the baseline mean for each of the five gender minority stress subscales measured. See below for T-scores and associated p-values for each statistical test.~Nonaffirmation (t = 3.76; p = .001) Internalized Transphobia (t = 2.01; p = .02) Negative Expectations (t = 2.06; p =.02) Community Connection (t = -0.82; p =.21) Pride (t = .01; p = .50 )"|||<.001
71070771|NCT04934189|141650420|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean for internalized transphobia was statistically different from the baseline mean.|t-test|2.01||||0.02|ONE_SIDED|||||The a priori threshold for statistical significance is p \< .05|t-test, 1 sided|||||||.02
71070772|NCT04934189|141650420|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean for identity nondisclosure was statistically different from the baseline mean.|t-test|1.61||||0.06|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.06
71070773|NCT04934189|141650420|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean for negative expectations was statistically different from the baseline mean.|t-test|2.06||||0.02|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.02
71070774|NCT04934189|141650420|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean for community connection was statistically different from the baseline mean.|t-test|-0.818||||0.21|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.21
71070775|NCT04934189|141650420|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean for pride was statistically different from the baseline mean.|t-test|0.009||||0.5|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.50
71070776|NCT04934189|141650423|OTHER||Chi-squared|5.59||||0.04|TWO_SIDED|||||A priori threshold for statistical significance was p \<.05|Chi-squared|||For this categorical data, chi-square tests of independence were performed to compare post-treatment (i.e., 3 month followup) vs 6 month followup numbers of participants reporting freedom from sexual victimization over a 6 month time period||||.04
71113716|NCT00673231|141735005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.0733|<|0.0001|TWO_SIDED|95.0|-0.74|-0.45||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided)||-0.45|-0.74|<0.0001
71113717|NCT00673231|141735006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.256||0.0001|TWO_SIDED|95.0|-1.5|-0.49||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.49|-1.50|0.0001
71113718|NCT00673231|141735006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.2523|<|0.0001|TWO_SIDED|95.0|-1.5|-0.5||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.50|-1.50|<0.0001
71113719|NCT00673231|141735006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.68|STANDARD_ERROR_OF_MEAN|0.2578|<|0.0001|TWO_SIDED|95.0|-2.19|-1.18||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-1.18|-2.19|<0.0001
71113720|NCT00673231|141735007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.87|STANDARD_ERROR_OF_MEAN|1.3195|<|0.0001|TWO_SIDED|95.0|-9.46|-4.28||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-4.28|-9.46|<0.0001
71113721|NCT00673231|141735007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.69|STANDARD_ERROR_OF_MEAN|1.3045|<|0.0001|TWO_SIDED|95.0|-8.25|-3.13||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-3.13|-8.25|<0.0001
71113722|NCT00673231|141735007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.23|STANDARD_ERROR_OF_MEAN|1.3286|<|0.0001|TWO_SIDED|95.0|-8.84|-3.63||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-3.63|-8.84|<0.0001
71113723|NCT00673231|141735008|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.2|STANDARD_ERROR_OF_MEAN|3.536||0.0427|TWO_SIDED|95.0|0.2|14.1||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|Regression, Logistic|Methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, adjustment for stratum (other oral anti-diab med use) and baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||14.1|0.2|0.0427
71113724|NCT00673231|141735008|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.8|STANDARD_ERROR_OF_MEAN|3.434||0.0903|TWO_SIDED|95.0|-0.9|12.5||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|Regression, Logistic|Methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, adjustment for stratum (other oral anti-diab med use) and baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||12.5|-0.9|0.0903
71113725|NCT00673231|141735008|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.7|STANDARD_ERROR_OF_MEAN|3.634||0.0166|TWO_SIDED|95.0|1.6|15.8||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|Regression, Logistic|Methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, adjustment for stratum (other oral anti-diab med use) and baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||15.8|1.6|0.0166
71113726|NCT00673231|141735009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.8|STANDARD_ERROR_OF_MEAN|4.684||0.0008|TWO_SIDED|95.0|-25.0|-6.6||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-6.6|-25.0|0.0008
71113727|NCT00673231|141735009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.1|STANDARD_ERROR_OF_MEAN|4.616|||TWO_SIDED|95.0|-31.2|-13.1||Not significant. Hierarchical closed testing procedure within treatment group stopped at previous endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-13.1|-31.2|
70852864|NCT00535288|141194577|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.9|||<|0.01|TWO_SIDED|95.0|-2.9|-0.9||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.9|-2.9|<0.01
70939173|NCT01263223|141379240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|||<|0.0001|TWO_SIDED|95.0|3.37|6.82||P-value if for the Mean Change in ABPM diastolic BP.|Mixed Models Analysis|||||6.82|3.37|<0.0001
70939174|NCT01263223|141379240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.53||||0.0005|TWO_SIDED|95.0|2.95|10.1||P-value is for the Maximum Change in ABPM diastolic BP.|Mixed Models Analysis|||||10.1|2.95|0.0005
70939175|NCT01263223|141379241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.8|||<|0.0001|TWO_SIDED|95.0|8.7|16.9||P-value is for the Mean Change in ABPM heart rate.|Mixed Models Analysis|||||16.9|8.7|<0.0001
70939176|NCT01263223|141379241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.0||||0.0001|TWO_SIDED|95.0|11.4|34.5||P-value is for the Maximum Change in ABPM heart rate.|Mixed Models Analysis|||||34.5|11.4|0.0001
70939177|NCT01263223|141379242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8||||0.212|TWO_SIDED|95.0|-1.6|7.2||P-value is for the Mean Change in ABPM Systolic BP.|Mixed Models Analysis|||||7.2|-1.6|0.2120
70939178|NCT01263223|141379242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.6||||0.064|TWO_SIDED|95.0|-0.4|15.5||P-value is for the Maximum Change in ABPM Systolic BP.|Mixed Models Analysis|||||15.5|-0.4|0.0640
71070777|NCT04934189|141650423|OTHER|For this categorical data, chi-square tests of independence were performed to compare post-treatment (i.e., 3 month followup) vs 6 month followup numbers of participants reporting any exposure to nonpenetrative sexual assault over a 6 month time period|Chi-squared|0.21||||0.55|TWO_SIDED|||||A priori threshold for statistical significance was p \< .05|Chi-squared|||||||.55
71070778|NCT04934189|141650423|OTHER|For this categorical data, chi-square tests of independence were performed to compare post-treatment (i.e., 3 month followup) vs 6 month followup numbers of participants reporting exposure to rape over a 6 month time period|Chi-squared|0.11||||0.59|TWO_SIDED|||||A priori threshold for statistical significance was p \< .05|Chi-squared|||||||.59
71070779|NCT04934189|141650425|OTHER||Mean Difference (Net)|-0.08|STANDARD_DEVIATION|1.68||0.38|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month) mean was statistically different from the baseline mean.||||.38
71070780|NCT04934189|141650426|OTHER||Mean Difference (Net)|-0.265|STANDARD_DEVIATION|2.21||0.25|ONE_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month) mean was statistically different from the baseline mean.||||.25
71113728|NCT00673231|141735009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.0|STANDARD_ERROR_OF_MEAN|4.718|<|0.0001|TWO_SIDED|95.0|-34.3|-15.8||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-15.8|-34.3|<0.0001
70939179|NCT01263223|141379242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6||||0.0211|TWO_SIDED|95.0|0.5|6.7||P-value is for the Mean Change in ABPM Diastolic BP.|Mixed Models Analysis|||||6.7|0.5|0.0211
70939180|NCT01263223|141379242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.8719|TWO_SIDED|95.0|-5.7|6.8||P-value is for the Maximum Change in ABPM Diastolic BP.|Mixed Models Analysis|||||6.8|-5.7|0.8719
70939181|NCT01263223|141379243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.7133|TWO_SIDED|95.0|-5.3|3.7||P-value is for the Mean Change in ABPM heart rate.|Mixed Models Analysis|||||3.7|-5.3|0.7133
70939182|NCT01263223|141379243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7||||0.4638|TWO_SIDED|95.0|-17.2|7.9||P-value is for the Maximum Change in ABPM heart rate.|Mixed Models Analysis|||||7.9|-17.2|0.4638
70939183|NCT01263223|141379244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.6|||<|0.0001|TWO_SIDED|95.0|11.3|15.9||P-value is for the Mean Change in ABPM heart rate.|Mixed Models Analysis|||||15.9|11.3|<0.0001
71070781|NCT03962790|141650427|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the credible interval (CrI) of the mean difference between Test and Control was greater than -5.|Posterior Mean Difference|0.09|STANDARD_DEVIATION|2.281|||TWO_SIDED|95.0|-4.37|4.65|||||Posterior mean difference was calculated as Test - Control|Bayesian repeated measurement random-effects model was used to compare between Test and Control lenses.||4.65|-4.37|
71070782|NCT03962790|141650428|NON_INFERIORITY|Non-inferiority is established if the lower limit of the 95% credible interval is above -5 points in CLUE Scale.|Posterior Mean Difference|-1.02|STANDARD_DEVIATION|1.565|||TWO_SIDED|95.0|-4.07|2.06|||||Posterior mean difference was calculated as Test - Control|Bayesian repeated measurement random-effects model was used to compare between Test and Control lenses.||2.06|-4.07|
71070783|NCT03962790|141650429|NON_INFERIORITY|Non-inferiority was declared if the upper bound of the CrI of the mean difference between Test and Control was less than 0.05.|Posterior Mean Difference|-0.001|STANDARD_DEVIATION|0.0054|||TWO_SIDED|95.0|-0.012|0.01|||||Posterior mean difference was calculated as Test - Control|Bayesian repeated measurement random-effects model was used to compare between Test and Control lenses.||0.010|-0.012|
71070784|NCT03962790|141650429|NON_INFERIORITY|Non-inferiority was declared if the upper bound of the CrI of the mean difference between Test and Control was less than 0.05.|Posterior Mean Difference|-0.002|STANDARD_DEVIATION|0.0057|||TWO_SIDED|95.0|-0.014|0.009|||||Posterior mean difference was calculated as Test - Control|Bayesian repeated measurement random-effects model was used to compare between Test and Control lenses.||0.009|-0.014|
71070785|NCT03962790|141650430|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the CrI of the mean difference between Test and Control was greater than -1.|Posterior Mean Difference|0.02|STANDARD_DEVIATION|0.168|||TWO_SIDED|95.0|-0.32|0.34|||||Posterior mean difference was calculated as Test - Control|Bayesian repeated measurement random-effects model was used to compare between Test and Control lenses.||0.34|-0.32|
71113729|NCT03594747|141735011|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.0001|TWO_SIDED|95.0|0.37|0.74|||One-sided stratified log-rank test|||||0.74|0.37|0.0001
71113730|NCT03594747|141735011|SUPERIORITY||Hazard Ratio (HR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.33|0.67|||One-sided stratified log-rank test|||||0.67|0.33|<0.0001
70939184|NCT01263223|141379244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.6|||<|0.0001|TWO_SIDED|95.0|21.1|34.2||P-value is for the Maximum Change in ABPM heart rate.|Mixed Models Analysis|||||34.2|21.1|<0.0001
70939185|NCT01263223|141379245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.9609|TWO_SIDED|95.0|-4.9|4.7||P-value is for the Mean Change in ABPM Systolic BP.|Mixed Models Analysis|||||4.7|-4.9|0.9609
71113731|NCT03594747|141735012|SUPERIORITY||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.32|0.61||||||||0.61|0.32|
71113732|NCT03594747|141735012|SUPERIORITY||Hazard Ratio (HR)|0.42|||||TWO_SIDED|95.0|0.3|0.59||||||||0.59|0.30|
71113733|NCT00943098|141735086|NON_INFERIORITY_OR_EQUIVALENCE|The sample size calculation was based on a hypothesis of non-inferiority of Diclofenac HPBCD 75mg/ml s.c. versus Voltarol® 75mg/3ml i.m. with regard to the primary efficacy variable (PID at 1.5 hours after study drug administration). The clinically significant difference (delta) between groups was defined in 15 mm of pain intensity difference (a 30% decline from starting levels of pain intensity of 50 mm or greater on a 0 to 100 VAS).|Mean Difference (Final Values)|-0.71||||0.813|TWO_SIDED|95.0|-6.62|5.2|||ANCOVA|||Assuming a difference in means of 0 mm, a common standard deviation of 22.5 mm, a sample size of 60 subjects in each group had 95% power to reject the null hypothesis.||5.20|-6.62|0.813
71113734|NCT00943098|141735099|NON_INFERIORITY_OR_EQUIVALENCE|The sample size calculation was based on a hypothesis of non-inferiority of Diclofenac HPBCD 75mg/ml s.c. versus Voltarol® 75mg/3ml i.m. with regard to the primary efficacy variable (PID at 1.5 hours after study drug administration). The clinically significant difference (delta) between groups was defined in 15 mm of pain intensity difference (a 30% decline from starting levels of pain intensity of 50 mm or greater on a 0 to 100 VAS).|Mean Difference (Final Values)|-0.51||||0.862|TWO_SIDED|95.0|-6.23|5.22|||ANCOVA|||Assuming a difference in means of 0 mm, a common standard deviation of 22.5 mm, a sample size of 60 subjects in each group had 95% power to reject the null hypothesis.||5.22|-6.23|0.862
71113735|NCT00281099|141735105|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority analysis was performed, with the hazard ratio as the parameter of interest and the non-inferiority threshold of 1.21. The one-sided upper confidence bound for the hazard ratio had to be less than 1.21 for the null hypothesis to be rejected. The threshold of 1.21 was derived by using a noninferiority threshold of a 5 percentage point difference in 24 month event-free rates.|Hazard Ratio (HR)|1.139||||||96.3|1.139|1.59||There were 167 events by 90 subjects in the VVI 40 arm, compared to 188 events among 104 subjects in the MVP arm.|Andersen-Gill Model|An Andersen-Gill model was used to account for multiple primary endpoints per subject.|4 interim analyses were performed \& the O'Brien-Fleming alpha-spending function required a 96.3% confidence interval.|"This is a multiple events survival analysis, with time to first primary endpoint, time between successive endpoints, and time from last endpoint to last follow-up visit determined for each subject. The null hypothesis is that the mortality/ heart failure (HF) urgent care/HF hospitalization hazard rate for patients with no Class I pacing indication and MVP is greater than that of similar patients with VVI 40."||1.590|1.139|
71113736|NCT00281099|141735106|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority analysis was performed, with the hazard ratio as the parameter of interest and the non-inferiority threshold of 1.241. The one-sided upper confidence bound for the hazard ratio had to be less than 1.241 for the null hypothesis to be rejected. The threshold of 1.241 was derived by using a non-inferiority threshold of a 5 percentage point difference in 24 month HF event-free rates.|Hazard Ratio (HR)|1.029||||||95.0|1.029|1.381|||Andersen-Gill Model|An Andersen-Gill model was utilized to account for multiple HF events per subject.||This is a multiple events survival analysis, and so the time from randomization to first HF event, time between successive HF events, and time from last HF event to last follow-up visit was determined for each subject. Since non-inferiority analysis is intended to prove that one therapy is equivalent or superior to another therapy, the null hypothesis being tested is that the worsening HF hazard rate for patients with MVP programming is greater than that of patients with VVI 40 programming.||1.381|1.029|
71113737|NCT00281099|141735107|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori alpha level for each covariate was 0.05. The p-value outcome provided is for the randomization arm main effect and all interactions between randomization arm and time.|Cumulative Logits Model|The analysis included data for all four time points (baseline, 12, 24, and 36 months) and all NYHA levels.||A model with covariates for time and randomization arm was fit to test the null hypothesis that the risk of worsening NYHA status over time among patients with MVP programming was equal to that of patients with VVI 40 programming. This analysis combined NYHA IV and Death into one category. The model included interaction terms for time and randomization arm.||||> 0.05
71113738|NCT00281099|141735107|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori alpha level for each covariate was 0.05. The p-value outcome provided is for the randomization arm main effect and all interaction terms between randomization arm and time.|Cumulative Logit Model|The analysis included data for all four time points (baseline, 12, 24, and 36 months) and all NYHA levels.||The null hypothesis for this analysis was the same as for the prior analysis: that the risk of worsening NYHA status over time among patients with MVP programming was equal to that of patients with VVI 40 programming. In this analysis, however, death was considered a 5th category in addition to NYHA I-IV. An interaction term for time and randomization arm was also included.||||> 0.05
71113739|NCT00281099|141735108|SUPERIORITY_OR_OTHER||||||>|0.1||95.0||||In each case the a priori threshold for significance for Arm was 0.05.|Mixed Models Analysis|Model fit with time and arm as covariates, the interaction between them included. Interaction shown to not be significant and model refit without it.||A linear mixed model was fit for each of the followoing: LVEDD, LVESD, Septal Wall Thickness, and Posterior Wall Thickness; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. Data were also collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.||||> 0.10
71113740|NCT00281099|141735109|SUPERIORITY_OR_OTHER||||||>|0.1||95.0||||The a priori threshold for significance for Arm was 0.05, with no adjustment for multiple analyses.|Mixed Models Analysis|Models were fit with time and arm as covariates.||A linear mixed model was fit for each of the following: LV Ejection Fraction and LV Fractional Shortening; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. Two-sided tests were used. Data were also collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.||||> 0.10
70852865|NCT00535288|141194578|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.07|||<|0.01|TWO_SIDED|95.0|-0.12|-0.01||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||-0.01|-0.12|<0.01
71113741|NCT00281099|141735110|SUPERIORITY_OR_OTHER|||||||0.0424||95.0||||The a priori threshold for statistical significance for Arm was 0.05, with no correction for multiple comparisons.|Mixed Models Analysis|The model was fit with time and arm as covariates.||"A linear mixed model was fit to test whether patients with MVP and no pacing indication had a different values for left ventricular end diastolic volume (LVEDV) over time than similar patients with VVI 40. A two-sided test was used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits."||||0.0424
71113742|NCT00281099|141735110|SUPERIORITY_OR_OTHER||||||>|0.1||95.0||||In each case the a priori threshold for significance for Arm was 0.05.|Mixed Models Analysis|Models were fit with time and arm as covariates.||"Similar models were fit for left ventricle (LV) End Systolic Volume and Left Atrial Volume."||||>0.10
71113743|NCT00281099|141735111|SUPERIORITY_OR_OTHER|||||||0.0418||95.0||||The a priori threshold for significance for Arm was 0.05, with no adjustment for multiple analyses.|Mixed Models Analysis|The model fit with time and arm as covariates.||A linear mixed model was fit to test whether patients with MVP and no pacing indication had a different values of Left Ventricular Sphericity Index over time than similar patients with VVI 40. A two-sided test was used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.||||0.0418
71113744|NCT00281099|141735112|SUPERIORITY_OR_OTHER||||||>|0.1||95.0||||The a priori threshold for statistical significance for Arm was 0.05, with no correction for multiple comparisons.|Mixed Models Analysis|Models were fit with time and arm as covariates.||A linear mixed model was fit for each of the following: TR Velocity, Mitral Inflow-peak E and Mitral Inflow-peak A; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. Two-sided tests were used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.||||> 0.10
71113745|NCT00281099|141735113|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||The a priori threshold for significance for Arm was 0.05, with no adjustment for multiple analyses.|Mixed Models Analysis|Model fit with time and arm as covariates.||A linear mixed model was fit for Mitral Inflow - Deceleration time; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. A two-sided test was used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.||||0.9490
71113746|NCT00281099|141735114|SUPERIORITY_OR_OTHER||||||>|0.1||95.0||||The a priori threshold for significance for Arm was 0.05, with no adjustment for multiple analyses.|Mixed Models Analysis|Models fit with time and arm as covariates.||A linear mixed model was fit for each of the following: Left Atrial Area and Mitral Regurgitation Area; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. Two-sided tests were used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.||||> 0.10
71113747|NCT00281099|141735115|SUPERIORITY_OR_OTHER|||||||0.8403||95.0||||The a priori threshold for significance for Arm was 0.05.|Cumulative Logits Model|Because Composite Mitral Regurgitation Score was measured on the ordinal scale, a GEE cumulative logits model was fit.||"A General Estimating Equation (GEE) Cumulative Logits model was fit with Arm, Time, and their interaction as covariates in the model to test the hypothesis that patients with no pacing indication and MVP programming have different Mitral Regurgation over time than similar patients with VVI 40 programming. A two-sided test was used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits."||||0.8403
71113748|NCT00281099|141735116|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.949||||||95.0|0.949|1.209|||Andersen-Gill model|This model was fit to account for multiple events (i.e. days in which true VT/VF occurred) within subject.|Because of the possible correlation within subject of days with episodes, a subsequent analysis was done using a bootstrap confidence interval for the annualized rate of episodes per patient month.|The pre-specified analysis called for a comparison of the hazard rates of true VT/VF between the two arms by way of a one-sided 95% confidence interval on the hazard ratio (values less than one favor MVP) after fitting a model. The unit of time was days, not episodes, so the analysis did not account for multiple episodes on the same day. If the upper bound was less than 1, the null hypothesis of equal hazard rates would be rejected.||1.209|0.949|
71113749|NCT00281099|141735116|SUPERIORITY_OR_OTHER||Difference in Annualized Rates|-0.015||||||95.0|-0.015|0.033|||Bootstrap Confidence Interval|||A 95% one-sided bootstrap confidence interval was generated for the MVP - VVI 40 difference in annualized rates of true VT/VF per patient month. If the interval upper bound was less than 0, the null hypothesis of equal rates would be rejected.||0.033|-0.015|
71113750|NCT00281099|141735116|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||||95.0|1.31|1.858|||Andersen-Gill model|This model was fit to account for multiple events (i.e. days in which non-VT/VF detected by device as VT/VF) within subject.|Because of the possible correlation within a subject for days with episodes, a subsequent analysis was done using a bootstrap confidence interval for the annualized rate of episodes per patient month.|The pre-specified analysis called for a comparison of the hazard rates of inappropriately detected non-VT/VF between the two arms by way of a one-sided 95% confidence interval on the hazard ratio (MVP in numerator) after fitting a model. The unit of time was days, not episodes, so the analysis did not account for multiple episodes on the same day. If the upper bound was less than 1, the null hypothesis of equal hazard rates would be rejected.||1.858|1.310|
71113751|NCT00281099|141735116|SUPERIORITY_OR_OTHER||Difference in Annualized Rates|0.017||||||95.0|0.017|0.036|||Bootstrap Confidence Interval|||A 95% one-sided bootstrap confidence interval was generated for the MVP - VVI 40 difference in annualized rates of inappropriately detected non-VT/VF per patient month. If the interval upper bound was less than 0, the null hypothesis of equal rates would be rejected.||0.036|0.017|
71113752|NCT00281099|141735117|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22||||0.7166||95.0|1.22|3.0||The threshold for significance was the one-sided upper confidence bound being less than 1.|Andersen-Gill model|||This analysis compared the hazard rates for clinically important AF (defined as a calendar day with \>20 hour of AT/AF as measured by the device). The null hypothesis was that this hazard rate for patients with MVP was equal to or greater than that of patients with VVI 40. The pre-specified model had Arm as a covariate, and accounted for time to first event and time between successive events per subject.||3.0|1.22|0.7166
71113753|NCT00281099|141735117|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15|||||TWO_SIDED|95.0|-100.0|0.8||The threshold for significance was defined as the upper one-sided confidence bound being less than 0.|Bootstrap Confidence Interval|||This analysis compared the percentage of days with \>20 hours of AT/AF as measured by the device(definition of clinically important AF) between arms. The null hypothesis was that this percentage of days for patients with MVP was equal or greater to that of patients with VVI 40.||0.8|-100|
71113754|NCT00281099|141735117|SUPERIORITY_OR_OTHER|||||||0.325||95.0||||The a priori threshold for statistical significance was 0.05.|Log Rank|A one-sided test was used.||This analysis tested the null hypothesis that the hazard rate for development of persistent AF(defined as 2 consecutive visits presenting with AT/AF, 7 consecutive days of 22 or more hours per day of AT/AF, or \< 7 such days due to a cardioversion) in patients with MVP and no pacing indication was equal to or greater than that of similar patients with VVI 40.||||0.325
71113755|NCT00281099|141735117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||95.0|0.0|0.145||The a priori threshold for significance was defined as the one-sided upper 95% confidence bound for the MVP - VVI 40 difference in average AT/AF through 6 months being less than 0.|Bootstrap Confidence Interval|||This analysis tested the hypothesis that the average AT/AF burden (hours per day of AT/AF) through 6 months post-implant in patients with no Class I pacing indication and MVP is equal to or greater than that of similar patients with VVI 40. Only subjects with complete AT/AF data for this time interval were included in the analysis.||0.145|0|
71113756|NCT00281099|141735117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||95.0|0.0|0.227||The a priori threshold for significance was defined as the one-sided upper 95% confidence bound for the MVP - VVI 40 difference in average AT/AF burden from 6 to 12 months being less than 0.|Bootstrap Confidence Interval|||This analysis tested the hypothesis that the average AT/AF burden (hours per day of AT/AF) from 6 to 12 months post-implant in patients with no Class I pacing indication and MVP is equal to or greater than that of similar patients with VVI 40. Only subjects with complete AT/AF data for this time interval were included in the analysis.||0.227|0|
71113757|NCT00281099|141735117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||95.0|0.0|0.261||The a priori threshold for significance was defined as the one-sided upper 95% confidence bound for the MVP - VVI 40 difference in average AT/AF burden from 12 to 24 months being less than 0.|Bootstrap Confidence Interval|||This analysis tested the hypothesis that the average AT/AF burden (hours per day of AT/AF) from 12 to 24 months post-implant in patients with no Class I pacing indication and MVP is equal to or greater than that of similar patients with VVI 40. Only subjects with complete AT/AF data for this time interval were included in the analysis.||0.261|0|
71113758|NCT00281099|141735117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||||95.0|-0.1|0.11||The a priori threshold for significance was defined as the one-sided upper 95% confidence bound for the MVP - VVI 40 difference in average AT/AF burden from 24 to 36 months being less than 0.|Bootstrap Confidence Interval|||This analysis tested the hypothesis that the average AT/AF burden (hours per day of AT/AF) from 24 to 36 months post-implant in patients with no Class I pacing indication and MVP is equal to or greater than that of similar patients with VVI 40. Only subjects with complete AT/AF data for this time interval were included in the analysis.||0.110|-0.1|
71113759|NCT00281099|141735118|SUPERIORITY_OR_OTHER|||||||0.0053||95.0||||The a priori threshold for statistical significance was 0.05. The threshold was met, and the null hypothesis rejected.|Log Rank|||Physicians recorded at each scheduled and unscheduled follow-up whether the subject had developed a Class I indication since their last visit. The time from randomization to Class I indication development or last visit if censored was determined for each subject. The null hypothesis was that the hazard rate for time to development of a Class I pacing indication among patients with MVP programming was equal to or greater than that of patients with VVI 40 programming.||||0.0053
71113760|NCT00281099|141735120|SUPERIORITY_OR_OTHER|||||||0.9791||95.0||||The one-sided Wilcoxon Rank Sum test yielded a p-value greater than 0.05, which was the a priori threshold for significance.|Wilcoxon (Mann-Whitney)|||All subjects from the analysis cohort with available data for the time period of interest were included in the corresponding analysis. The null hypothesis was that the average percent ventricular pacing through 6 months post-implant for patients with MVP programming and was greater than or equal to that of patients with VVI 40 programming.||||0.9791
70939186|NCT01263223|141379245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8||||0.2731|TWO_SIDED|95.0|-3.9|13.6||P-value is for the Maximum Change in ABPM Systolic BP.|Mixed Models Analysis|||||13.6|-3.9|0.2731
70852866|NCT00535288|141194578|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.06||||0.02|TWO_SIDED|95.0|-0.11|-0.01||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||-0.01|-0.11|0.02
70852867|NCT00535288|141194578|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.07|||<|0.01|TWO_SIDED|95.0|-0.13|-0.02||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||-0.02|-0.13|<0.01
70852868|NCT00535288|141194578|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.08|||<|0.01|TWO_SIDED|95.0|-0.14|-0.03||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||-0.03|-0.14|<0.01
70852869|NCT00535288|141194579|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.0||||0.08|TWO_SIDED|95.0|-2.1|0.1||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||0.1|-2.1|0.08
70852870|NCT00535288|141194579|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.6|||<|0.01|TWO_SIDED|95.0|-2.7|-0.5||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.5|-2.7|<0.01
70939187|NCT01263223|141379245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.3779|TWO_SIDED|95.0|-4.8|1.8||P-value is for the Mean Change in ABPM Diastolic BP.|Mixed Models Analysis|||||1.8|-4.8|0.3779
70939188|NCT01263223|141379245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0||||0.0828|TWO_SIDED|95.0|-12.8|0.8||P-value is for the Maximum Change in ABPM Diastolic BP.|Mixed Models Analysis|||||0.8|-12.8|0.0828
70939189|NCT02246647|141379246|OTHER||Mean Difference (Final Values)|0.01||||0.87|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.87
71113761|NCT00281099|141735120|SUPERIORITY_OR_OTHER|||||||0.8984||95.0||||The one-sided Wilcoxon Rank Sum test yielded a p-value greater than 0.05, which was the a priori threshold for significance.|Wilcoxon (Mann-Whitney)|Alternative hypothesis:patients with MVP \& no pacing indication have less mean ventricular pacing through 12 months than similar patients with VVI 40.||All subjects from the analysis cohort with available data for the time period of interest were included in the corresponding analysis. The null hypothesis was that the average percent ventricular pacing through 12 months post-implant for patients with MVP programming was greater than or equal to that of patients with VVI 40 programming.||||0.8984
71113762|NCT00281099|141735120|SUPERIORITY_OR_OTHER|||||||0.7144||95.0||||The one-sided Wilcoxon Rank Sum test yielded a p-value greater than 0.05, which was the a priori threshold for significance.|Wilcoxon (Mann-Whitney)|Alternative hypothesis:patients with MVP \& no pacing indication have less mean ventricular pacing through 24 months than similar patients with VVI 40.||All subjects from the analysis cohort with available data for the time period of interest were included in the corresponding analysis. The null hypothesis was that the average percent ventricular pacing through 24 months post-implant for patients with MVP programming and no pacing indication was greater than or equal to that of patients with VVI 40 programming and no pacing indication.||||0.7144
71113763|NCT00281099|141735120|SUPERIORITY_OR_OTHER|||||||0.5165||95.0||||The one-sided Wilcoxon Rank Sum test yielded a p-value greater than 0.05, which was the a priori threshold for significance.|Wilcoxon (Mann-Whitney)|Alternative hypothesis:patients with MVP \& no pacing indication have less mean ventricular pacing through 36 months than similar patients with VVI 40.||All subjects from the analysis cohort with available data for the time period of interest were included in the corresponding analysis. The null hypothesis was that the average percent ventricular pacing through 36 months post-implant for patients with MVP programming and no pacing indication was greater than or equal to that of patients with VVI 40 programming and no pacing indication.||||0.5165
71113764|NCT00281099|141735121|SUPERIORITY_OR_OTHER|||||||0.0073||95.0||||The p-value is not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||For the KCCQ Physical Limitation Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.0073
71113765|NCT00281099|141735121|SUPERIORITY_OR_OTHER|||||||0.2493||95.0||||No adjustment was made for multiple comparisons, and the a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||For the KCCQ Symptom Stability Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.2493
71113766|NCT00281099|141735121|SUPERIORITY_OR_OTHER|||||||0.7728||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Symptom Frequency Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.7728
71113767|NCT00281099|141735121|SUPERIORITY_OR_OTHER|||||||0.3082||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons|Wilcoxon (Mann-Whitney)|||For the KCCQ Symptom Burden Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.3082
70852871|NCT00535288|141194579|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.5|||<|0.01|TWO_SIDED|95.0|-2.7|-0.4||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.4|-2.7|<0.01
70939190|NCT04387773|141379260|SUPERIORITY||Mean Difference (Final Values)|2.3|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||We hypothesized that GOCOVRI would result in an increase of daily activity due to improvement in LID symptoms.||||>.05
70939191|NCT04387773|141379261|SUPERIORITY||Mean Difference (Final Values)|14.98|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||We hypothesized that GOCOVRI would result in an increase of daily activity due to improvement in LID symptoms.||||>.05
71113768|NCT00281099|141735121|SUPERIORITY_OR_OTHER|||||||0.5422||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Total Symptom Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.5422
71113769|NCT00281099|141735121|SUPERIORITY_OR_OTHER|||||||0.0851||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Self-Efficacy Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.0851
70939192|NCT04387773|141379262|SUPERIORITY||Mean Difference (Final Values)|2393.2||||0.037|TWO_SIDED||||||t-test, 2 sided|||||||0.037
70939193|NCT04387773|141379263|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.012|TWO_SIDED||||||t-test, 2 sided|||||||0.012
70939194|NCT04387773|141379264|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.047|TWO_SIDED||||||t-test, 2 sided|||||||0.047
70939195|NCT03557307|141379266|OTHER||percentage|62.9|||||TWO_SIDED|95.0|58.86|66.76|||Clopper-Pearson Exact CI|One sample Confidence Interval|Percentage of patients who achieved 100% reduction in daily OCS dose that are sustained over at least 4 weeks without worsening of asthma|||66.76|58.86|
71113770|NCT00281099|141735121|SUPERIORITY_OR_OTHER|||||||0.0502||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Quality of Life Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.0502
71070786|NCT01286168|141650433|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||McNemar|||Antisepsis and Control sides were compared.||||0.02
71113771|NCT00281099|141735121|SUPERIORITY_OR_OTHER|||||||0.0463||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Social Limitation Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.0463
71113772|NCT00281099|141735121|SUPERIORITY_OR_OTHER|||||||0.0227||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Overall Summary Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.0227
71113773|NCT00281099|141735121|SUPERIORITY_OR_OTHER|||||||0.0582||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Overall Clinical Summary Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.0582
71113774|NCT00281099|141735121|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Tests for all ten KCCQ subscores yielded p-values greater than 0.15 (the a priori threshold for statistical significance was 0.05).|Wilcoxon (Mann-Whitney)|||The 10 KCCQ analyses were repeated comparing changes from baseline to 24 months between arms. Again if a subject died prior to their 24 month visit, a value of 0 was imputed for their 24 month score.||||> 0.15
71113775|NCT00281099|141735121|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Tests for all 10 KCCQ subscores yielded p-values greater than 0.15 (the a priori threshold for statistical significance was 0.05).|Wilcoxon (Mann-Whitney)|Because the trial was stopped early, only 178 subjects were included in these analyses.||The 10 KCCQ analyses were repeated comparing changes from baseline to 36 months between arms. Again if a subject died prior to their 36 month visit, a value of 0 was imputed for their 36 month score.||||> 0.15
71113776|NCT00281099|141735121|SUPERIORITY_OR_OTHER|||||||0.1399||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The change in Minnesota Living with Heart Failure Questionnaire score from baseline to 12 months was compared using a two-sided test. If a subject died before their 12 month visit, a value of 105 (worst possible MLWHF score) was imputed for their 12 month score.||||0.1399
70852872|NCT00535288|141194579|SUPERIORITY_OR_OTHER||Difference between least squares means|-2.0|||<|0.01|TWO_SIDED|95.0|-3.1|-0.9||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.9|-3.1|<0.01
71070787|NCT01286168|141650434|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||McNemar|||Antisepsis and Control sides were compared.||||0.03
71070788|NCT01286168|141650435|SUPERIORITY_OR_OTHER|||||||0.003|||||||McNemar|||Antisepsis and Control sides were compared.||||0.003
71070789|NCT01286168|141650436|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||McNemar|||Antisepsis and Control sides were compared.||||0.13
71070790|NCT01286168|141650437|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||McNemar|||Antisepsis and Control sides were compared.||||0.45
71113777|NCT00281099|141735121|SUPERIORITY_OR_OTHER|||||||0.3573||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The change in Minnesota Living with Heart Failure Questionnaire score from baseline to 24 months was compared using a two-sided test. If a subject died before their 24 month visit, a value of 105 (worst possible MLWHF score) was imputed for their 24 month score.||||0.3573
71113778|NCT00281099|141735121|SUPERIORITY_OR_OTHER|||||||0.5183||95.0||||The a priori threshold for statistical significance was 0.05, with no adjustment made for multiple comparisons.|Wilcoxon (Mann-Whitney)|Because the trial was stopped early, only 178 subjects were included in this analysis.||The change in Minnesota Living with Heart Failure Questionnaire score from baseline to 36 months was compared using a two-sided test. If a subject died before their 36 month visit, a value of 105 (worst possible MLWHF score) was imputed for their 36 month score.||||0.5183
70852873|NCT00535288|141194582|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.06||||0.07|TWO_SIDED|95.0|-0.12|0.0||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||0.00|-0.12|0.07
71070791|NCT01286168|141650438|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|||Antisepsis and Control sides were compared. Unadjusted p-value from generalized linear mixed effect model accounting for correlation among multiple drains from the same patient.||||0.02
71070792|NCT01286168|141650438|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|||Antisepsis and Control sides were compared. P-value from generalized linear mixed effect model accounting for correlation among multiple drains from the same patient. P-value was adjusted for side- and drain-specific variables: indication (cancer or prophylaxis), operation (mastectomy only, mastectomy+SLNB, mastectomy +ALND), and drain duration.||||0.02
71070793|NCT01286168|141650439|SUPERIORITY_OR_OTHER|||||||0.004|||||||Likelihood-ratio test|||Antisepsis and Control sides were compared. Due to zero events in the antisepsis side for this endpoint, p-value was derived from likelihood-ratio test comparing the intercept only model to the model with intercept and treatment side included.||||0.004
71117696|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-67.2|||<|0.001|TWO_SIDED|95.0|-82.87|-51.52||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-51.52|-82.87|<0.001
71113779|NCT00281099|141735122|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority analysis was performed, with the hazard ratio as the parameter of interest and the non-inferiority threshold of 1.44. The one-sided upper confidence bound for the hazard ratio had to be less than 1.44 for the null hypothesis to be rejected. The threshold of 1.44 was derived by using a noninferiority threshold of a 5 percentage point difference in 24 month survival rates.|Hazard Ratio (HR)|1.26||||||95.0|1.26|1.75|||||This was a non-inferiority analysis, and so a one-sided 95% confidence interval was performed comparing the MVP arm to the VVI 40 arm.|The time from randomization to all cause mortality or last follow-up visit was determined for each subject. The null hypothesis was that the mortality hazard rate for patients with MVP programming was greater than that of patients with VVI40 programming.||1.75|1.26|
71113780|NCT04621240|141735124|SUPERIORITY|Mean level change from pre- to post-testing|Mean Difference (Net)|10.3|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71113781|NCT04621240|141735124|OTHER|Regression of the change in BrainHealth Index on age|Slope|0.03||||0.55|TWO_SIDED||||||Regression, Linear|||||||0.55
71113782|NCT02712983|141735135|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.4|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-3.62|-1.22||||||Day 8 Cohort A: TIP, Pooled PBO||-1.22|-3.62|
71113783|NCT02712983|141735135|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.1|STANDARD_ERROR_OF_MEAN|0.58|||TWO_SIDED|95.0|-3.3|-0.98||||||Day 8 Cohort A: TIP/PBO, Pooled PBO||-0.98|-3.30|
71113784|NCT02712983|141735135|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.9|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-3.2|-0.68||||||Day 8 Cohort B: TIP, Pooled PBO||-0.68|-3.20|
70852874|NCT00535288|141194582|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.05||||0.24|TWO_SIDED|95.0|-0.11|0.02||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||0.02|-0.11|0.24
70852875|NCT00535288|141194582|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.04||||0.29|TWO_SIDED|95.0|-0.11|0.02||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||0.02|-0.11|0.29
71113785|NCT02712983|141735135|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.3|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-4.38|-2.15||||||Day 8 Cohort B: TIP/PBO, Pooled PBO|LS Mean Diff (SE) vs pooled placebo|-2.15|-4.38|
71113786|NCT02712983|141735135|OTHER||LS Mean Diff (SE) vs pooled placebo|-4.0|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|95.0|-5.06|-2.88||||||Day 8 Cohort C: TIP, Pooled PBO||-2.88|-5.06|
71113787|NCT02712983|141735135|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.4|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-4.57|-2.14||||||Day 8 Cohort C: TIP/PBO, Pooled PBO||-2.14|-4.57|
71113788|NCT02712983|141735135|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.8|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-3.66|-1.89||||||Day 8: Pooled TIP, Pooled PBO||-1.89|-3.66|
71113789|NCT02712983|141735135|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.9|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|95.0|-3.79|-2.05||||||Day 8: Pooled TIP/PBO, Pooled PBO||-2.05|-3.79|
71113790|NCT02712983|141735135|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.8|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-4.28|-1.31||||||Day 29 Cohort A: TIP, Pooled PBO||-1.31|-4.28|
71113791|NCT02712983|141735135|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.4|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|95.0|-4.03|-0.67||||||Day 29 Cohort A: TIP/PBO, Pooled PBO||-0.67|-4.03|
71113792|NCT02712983|141735135|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.3|STANDARD_ERROR_OF_MEAN|0.88|||TWO_SIDED|95.0|-4.04|-0.52||||||Day 29 Cohort B: TIP, Pooled PBO||-0.52|-4.04|
71113793|NCT02712983|141735135|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.5|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|95.0|-5.16|-1.85||||||Day 29 Cohort B: TIP/PBO, Pooled PBO||-1.85|-5.16|
71113794|NCT02712983|141735135|OTHER||LS Mean Diff (SE) vs pooled placebo|-4.6|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-6.13|-3.09||||||Day 29 Cohort C: TIP, Pooled PBO||-3.09|-6.13|
71113795|NCT02712983|141735135|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.1|STANDARD_ERROR_OF_MEAN|0.79|||TWO_SIDED|95.0|-4.68|-1.52||||||Day 29 Cohort C: TIP/PBO, Pooled PBO||-1.52|-4.68|
71113796|NCT02712983|141735135|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.2|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-4.43|-2.02||||||Day 29: Pooled TIP, Pooled PBO||-2.02|-4.43|
71113797|NCT02712983|141735135|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.0|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-4.19|-1.78||||||Day 29: Pooled TIP/PBO, Pooled PBO||-1.78|-4.19|
71113798|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.1|STANDARD_ERROR_OF_MEAN|0.87|||TWO_SIDED|95.0|-3.82|-0.36||||||Day 57 Cohort A: TIP, Pooled PBO||-0.36|-3.82|
71113799|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.5|STANDARD_ERROR_OF_MEAN|0.88|||TWO_SIDED|95.0|-2.21|1.29||||||Day 57 Cohort A: TIP/PBO, Pooled PBO||1.29|-2.21|
71113800|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.9|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-3.87|0.08||||||Day 57 Cohort B: TIP, Pooled PBO||0.08|-3.87|
71113801|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.6|STANDARD_ERROR_OF_MEAN|0.88|||TWO_SIDED|95.0|-3.34|0.16||||||Day 57 Cohort B: TIP/PBO, Pooled PBO||0.16|-3.34|
71113802|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.9|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|95.0|-5.5|-2.22||||||Day 57 Cohort C: TIP, Pooled PBO||-2.22|-5.50|
71070794|NCT01286168|141650440|SUPERIORITY_OR_OTHER|||||||0.003|||||||Mixed Models Analysis|||Antisepsis and Control sides were compared. Unadjusted p-value from generalized linear mixed effect model accounting for correlation among multiple drains from the same patient.||||0.003
71070795|NCT01286168|141650440|SUPERIORITY_OR_OTHER|||||||0.003|||||||Mixed Models Analysis|||Antisepsis and Control sides were compared. P-value from generalized linear mixed effect model accounting for correlation among multiple drains from the same patient. P-value was adjusted for side- and drain-specific variables: indication (cancer or prophylaxis), operation (mastectomy only, mastectomy+SLNB, mastectomy +ALND), and drain duration.||||0.003
71113803|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.4|STANDARD_ERROR_OF_MEAN|0.92|||TWO_SIDED|95.0|-3.26|0.41||||||Day 57 Cohort C: TIP/PBO, Pooled PBO||0.41|-3.26|
71113804|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.6|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|95.0|-3.98|-1.25||||||Day 57: Pooled TIP, Pooled PBO||-1.25|-3.98|
71113805|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.2|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|95.0|-2.5|0.19||||||Day 57: Pooled TIP/PBO, Pooled PBO||0.19|-2.50|
71113806|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.2|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-4.0|-0.38||||||Day 85 Cohort A: TIP, Pooled PBO||-0.38|-4.00|
71113807|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.8|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-3.81|0.13||||||Day 85 Cohort A: TIP/PBO, Pooled PBO||0.13|-3.81|
71113808|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.7|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|95.0|-4.96|-0.53||||||Day 85 Cohort B: TIP, Pooled PBO||-0.53|-4.96|
71113809|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.6|STANDARD_ERROR_OF_MEAN|0.93|||TWO_SIDED|95.0|-5.44|-1.73||||||Day 85 Cohort B: TIP/PBO, Pooled PBO||-1.73|-5.44|
71113810|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.0|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|-4.9|-1.07||||||Day 85 Cohort C: TIP, Pooled PBO||-1.07|-4.90|
71113811|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.6|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-4.66|-0.53||||||Day 85 Cohort C: TIP/PBO, Pooled PBO||-0.53|-4.66|
71113812|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.6|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|95.0|-4.11|-1.17||||||Day 85: Pooled TIP, Pooled PBO||-1.17|-4.11|
71113813|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.7|STANDARD_ERROR_OF_MEAN|0.72|||TWO_SIDED|95.0|-4.12|-1.23||||||Day 85: Pooled TIP/PBO, Pooled PBO||-1.23|-4.12|
71113814|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.8|STANDARD_ERROR_OF_MEAN|0.87|||TWO_SIDED|95.0|-4.55|-1.08||||||Day 113 Cohort A: TIP, Pooled PBO||-1.08|-4.55|
71113815|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|0.1|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|95.0|-1.61|1.71||||||Day 113 Cohort A: TIP/PBO, Pooled PBO||1.71|-1.61|
71113816|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.6|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|95.0|-4.93|-0.29||||||Day 113 Cohort B: TIP, Pooled PBO||-0.29|-4.93|
71113817|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.9|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|95.0|-3.62|-0.25||||||Day 113 Cohort B: TIP/PBO, Pooled PBO||-0.25|-3.62|
71113818|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.1|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|-4.94|-1.3||||||Day 113 Cohort C: TIP, Pooled PBO||-1.30|-4.94|
71113819|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.4|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|95.0|-4.37|-0.43||||||Day 113 Cohort C: TIP/PBO, Pooled PBO||-0.43|-4.37|
71113820|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.8|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-4.24|-1.45||||||Day 113: Pooled TIP, Pooled PBO||-1.45|-4.24|
71113821|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.4|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|95.0|-2.73|-0.13||||||Day 113: Pooled TIP/PBO, Pooled PBO||-0.13|-2.73|
71113822|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.2|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-3.64|-0.73||||||EoT Cohort A: TIP, Pooled PBO||-0.73|-3.64|
71113823|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.1|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-1.61|1.43||||||EoT Cohort A: TIP/PBO, Pooled PBO||1.43|-1.61|
71113824|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.3|STANDARD_ERROR_OF_MEAN|0.77|||TWO_SIDED|95.0|-2.81|0.25||||||EoT Cohort B: TIP, Pooled PBO||0.25|-2.81|
71113825|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.7|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-3.14|-0.22||||||EoT Cohort B: TIP/PBO, Pooled PBO||-0.22|-3.14|
71113826|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.4|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-3.89|-0.98||||||EoT Cohort C: TIP, Pooled PBO||-0.98|-3.89|
71113827|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.7|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-3.12|-0.22||||||EoT Cohort C: TIP/PBO, Pooled PBO||-0.22|-3.12|
71113828|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.0|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-3.08|-0.85||||||EoT: Pooled TIP, Pooled PBO||-0.85|-3.08|
71113829|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.1|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-2.25|-0.04||||||EoT: Pooled TIP/PBO, Pooled PBO||-0.04|-2.25|
71113830|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.8|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|-2.63|0.99||||||Day 141 Cohort A: TIP, Pooled PBO||0.99|-2.63|
71113831|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|0.1|STANDARD_ERROR_OF_MEAN|0.95|||TWO_SIDED|95.0|-1.83|1.98||||||Day 141 Cohort A: TIP/PBO, Pooled PBO||1.98|-1.83|
71070796|NCT04594941|141650464|OTHER||Least Sqaure (LS) Mean Difference|-0.149|STANDARD_ERROR_OF_MEAN|0.754||0.8452|TWO_SIDED|90.0|-1.431|1.133|||Mixed-effects model for repeated measure|||"Median of Readers: SPE VS HPLC~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||1.133|-1.431|0.8452
71070797|NCT04594941|141650464|OTHER||LS Mean Difference|-0.015|STANDARD_ERROR_OF_MEAN|1.109||0.989|TWO_SIDED|90.0|-1.899|1.868|||Mixed-effects model for repeated measure|||"SPE VS HPLC: Reader 1~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||1.868|-1.899|0.9890
71070798|NCT04594941|141650464|OTHER||LS Mean Difference|-0.753|STANDARD_ERROR_OF_MEAN|0.854||0.3852|TWO_SIDED|90.0|-2.204|0.698|||Mixed-effects model for repeated measure|||"Reader 2: SPE VS HPLC~Reader 2: Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||0.698|-2.204|0.3852
71070799|NCT04594941|141650464|OTHER||LS Mean Difference|-0.091|STANDARD_ERROR_OF_MEAN|0.968||0.926|TWO_SIDED|90.0|-1.735|1.554|||Mixed-effects model for repeated measure|||"Reader 3: SPE VS HPLC~Analysis was based on MMRM model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||1.554|-1.735|0.9260
71070800|NCT04594941|141650465|OTHER||LS Mean Difference|-0.219|STANDARD_ERROR_OF_MEAN|1.109||0.8452|TWO_SIDED|90.0|-2.104|1.667|||Mixed-effects model for repeated measure|||"Median of Readers: SPE VS HPLC~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||1.667|-2.104|0.8452
71070801|NCT04594941|141650465|OTHER||Least Square Mean (LSM) Difference|-0.023|STANDARD_ERROR_OF_MEAN|1.63||0.989|TWO_SIDED|90.0|-2.793|2.747|||Mixed-effects model for repeated measure|||"Reader 1: SPE VS HPLC~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||2.747|-2.793|0.9890
71079375|NCT02087943|141666394|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.17||||0.5286|TWO_SIDED|95.0|-21.34|10.99|||ANCOVA||Based on an analysis of covariance model with the percentage change from baseline as the response variable, treatment group and baseline EASI stratification (≤ 20, \> 20) as factors, and the baseline average weekly pruritus NRS score as a covariate.|||10.99|-21.34|0.5286
71079376|NCT02087943|141666394|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.17||||0.6092|TWO_SIDED|95.0|-20.22|11.88|||ANCOVA||Based on an analysis of covariance model with the percentage change from baseline as the response variable, treatment group and baseline EASI stratification (≤ 20, \> 20) as factors, and the baseline average weekly pruritus NRS score as a covariate.|||11.88|-20.22|0.6092
71079377|NCT03836209|141666397|SUPERIORITY||Proportion Difference|-0.071||||0.366|TWO_SIDED|90.0|-0.205|0.062||The threshold for statistical significance was p = 0.10.|Fisher Exact||Treatment Difference = Arm A - Arm B|||0.062|-0.205|0.366
71079378|NCT03836209|141666398|SUPERIORITY||Proportion Difference|-0.059||||0.446|TWO_SIDED|90.0|-0.191|0.073||The threshold for statistical significance was p = 0.10.|Fisher Exact||Treatment Difference = Arm A - Arm B|||0.073|-0.191|0.446
71079379|NCT03836209|141666399|SUPERIORITY||Proportion Difference|0.047||||0.539|TWO_SIDED|90.0|-0.084|0.178||The threshold for statistical significance was p = 0.10.|Fisher Exact||Treatment Difference = Arm A - Arm B|||0.178|-0.084|0.539
71079380|NCT03836209|141666400|SUPERIORITY||Proportion Difference|0.131||||0.042|TWO_SIDED|90.0|0.02|0.242||The threshold for statistical significance was p = 0.10.|Fisher Exact||Treatment Difference = Arm A - Arm B|||0.242|0.020|0.042
71079381|NCT01753115|141666405|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence margin is 0.80 - 1.25.|Ratio of AUC|0.887|||||TWO_SIDED|90.0|0.831|0.948||||||Analysis of Ciprofloxacin Area Under the Curve at Day 5 and Day 44.||0.948|0.831|
71079382|NCT01753115|141666405|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence margin is 0.80 - 1.25.|Ratio of Cmax|0.944|||||TWO_SIDED|90.0|0.852|1.046||||||Analysis of Cmax at Day 5 and Day 44||1.046|0.852|
71079383|NCT01753115|141666406|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.67.|Ratio of GMT|1.267|||||TWO_SIDED|95.0|0.898|1.787||||||||1.787|0.898|
71079384|NCT01424241|141666409|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|300.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||None available.||||<0.05
71079385|NCT01424241|141666409|SUPERIORITY||Mean Difference (Final Values)|1.6|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<.05
71079386|NCT05259917|141666413|SUPERIORITY||||||<|0.0001|||||||Gehan score transformation test|||"Gehan score transformation test:~KVD900 300 mg vs Placebo"||||<0.0001
71079387|NCT05259917|141666413|SUPERIORITY|||||||0.0013|||||||Gehan score transformation test|||"Gehan score transformation test:~KVD900 600 mg vs Placebo"||||0.0013
71079388|NCT05259917|141666414|SUPERIORITY|||||||0.0036|||||||Gehan score transformation test|||"Gehan score transformation test:~KVD900 300 mg vs Placebo"||||0.0036
71079389|NCT05259917|141666414|SUPERIORITY|||||||0.0032|||||||Gehan score transformation test|||"Gehan score transformation test:~KVD900 600 mg vs Placebo"||||0.0032
71070802|NCT04594941|141650465|OTHER||LS Mean Difference|-1.107|STANDARD_ERROR_OF_MEAN|1.256||0.3852|TWO_SIDED|90.0|-3.241|1.027|||Mixed-effects model for repeated measure|||"Reader 2: SPE VS HPLC~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||1.027|-3.241|0.3852
71079390|NCT05259917|141666415|SUPERIORITY|||||||0.0022|||||||Gehan score transformation test|||"Gehan score transformation test:~KVD900 300 mg vs Placebo"||||0.0022
71079391|NCT05259917|141666415|SUPERIORITY||||||<|0.0001|||||||Gehan score transformation test|||"Gehan score transformation test:~KVD900 600 mg vs Placebo"||||<0.0001
71079392|NCT00482170|141666416|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority test was performed using the 95 percent (%) confidence interval (CI) of the difference of mean participant satisfaction (alpha = 2.5%). Non-inferiority was demonstrated if the lower limit of the 2-sided CI is greater than -1.|Mean Difference (Final Values)|1.32|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|0.87|1.77||Statistical testing, one-sided, was done at 2.5% significance level.|ANOVA|||Analysis of variance (ANOVA) using mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an unstructured correlation was used for the analysis.||1.77|0.87|<0.001
71079393|NCT00482170|141666417|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority test was performed using the 95% CI of the difference of mean participant satisfaction (alpha = 2.5%). Non-inferiority was demonstrated if the lower limit of the 2-sided CI is greater than -1.|Mean Difference (Final Values)|1.41|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|0.95|1.87||Statistical testing, one-sided, was done at 2.5% significance level.|ANOVA|||ANOVA using a mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an unstructured correlation was used for the analysis.||1.87|0.95|<0.001
71079394|NCT00482170|141666418|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.12||||0.008|TWO_SIDED|95.0|2.05|126.9||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: Generalized Estimating Equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment group, visit and the interaction between treatment group and visit as fixed factors was used for the analysis.||126.9|2.05|0.008
71079395|NCT00482170|141666418|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.25||||0.002|TWO_SIDED|95.0|2.44|51.83||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: GEE model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment group, visit and the interaction between treatment group and visit as fixed factors was used for the analysis.||51.83|2.44|0.002
71079396|NCT00482170|141666418|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.88||||0.001|TWO_SIDED|95.0|2.26|27.44||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: GEE model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment group, visit and the interaction between treatment group and visit as fixed factors was used for the analysis.||27.44|2.26|0.001
71079397|NCT00482170|141666418|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.73|||<|0.001|TWO_SIDED|95.0|2.59|29.47||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used for the analysis.||29.47|2.59|<0.001
71079398|NCT00482170|141666419|SUPERIORITY_OR_OTHER||Regression coefficient|0.17||||0.045|TWO_SIDED|95.0|0.0|0.34||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 10 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.34|0.00|0.045
71070803|NCT04594941|141650465|OTHER||LS Mean Difference|-0.133|STANDARD_ERROR_OF_MEAN|1.424||0.926|TWO_SIDED|90.0|-2.552|2.285|||Mixed-effects model for repeated measure|||"Reader 3: SPE VS HPLC~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||2.285|-2.552|0.9260
71113832|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|0.2|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|95.0|-2.03|2.41||||||Day 141 Cohort B: TIP, Pooled PBO||2.41|-2.03|
70939196|NCT03557307|141379267|OTHER||percentage|81.9|||||TWO_SIDED|95.0|78.62|84.94|||Clopper-Pearson Exact CI|One sample Confidence Interval|Percentage of patients who achieve 100% reduction or a daily OCS dose of \<=5mg, if reason for no further OCS reduction is Adrenal Insufficiency, that are sustained over at least 4 weeks without worsening of asthma|||84.94|78.62|
71070804|NCT04594941|141650466|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 1||||<0.0001
71070805|NCT04594941|141650466|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 2||||<0.0001
71113833|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.8|STANDARD_ERROR_OF_MEAN|0.92|||TWO_SIDED|95.0|-3.68|-0.01||||||Day 141 Cohort B: TIP/PBO, Pooled PBO||-0.01|-3.68|
71113834|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.9|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|-2.78|1.07||||||Day 141 Cohort C (4 capsules b.i.d.): TIP, Pooled PBO||1.07|-2.78|
71113835|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.2|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|95.0|-3.36|0.89||||||Day 141 Cohort C: TIP/PBO, Pooled PBO||0.89|-3.36|
71113836|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.5|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|95.0|-1.97|0.98||||||Day 141: Pooled TIP, Pooled PBO||0.98|-1.97|
71113837|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.0|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-2.45|0.45||||||Day 141: Pooled TIP/PBO, Pooled PBO||0.45|-2.45|
71113838|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.3|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|-3.24|0.61||||||Day 169 Cohort A: TIP, Pooled PBO||0.61|-3.24|
71113839|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.1|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-3.05|0.91||||||Day 169 Cohort A: TIP/PBO, Pooled PBO||0.91|-3.05|
71113840|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.6|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|95.0|-2.73|1.62||||||Day 169 Cohort B: TIP, Pooled PBO||1.62|-2.73|
70939197|NCT03557307|141379268|OTHER||percentage|91.5|||||TWO_SIDED|95.0|88.94|93.58|||Clopper-Pearson Exact CI|One sample Confidence Interval|Percentage of patients who achieve a daily OCS dose of ≤5 mg (regardless of reason for no further OCS reduction), that are sustained over at least 4 weeks without worsening of asthma|||93.58|88.94|
71113841|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.1|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-4.22|-0.08||||||Day 169 Cohort B: TIP/PBO, Pooled PBO||-0.08|-4.22|
71113842|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.2|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|95.0|-2.48|2.1||||||Day 169 Cohort C: TIP, Pooled PBO||2.10|-2.48|
71113843|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.1|STANDARD_ERROR_OF_MEAN|1.12|||TWO_SIDED|95.0|-2.33|2.13||||||Day 169 Cohort C: TIP/PBO, Pooled PBO||2.13|-2.33|
71113844|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.7|STANDARD_ERROR_OF_MEAN|0.77|||TWO_SIDED|95.0|-2.24|0.86||||||Day 169: Pooled TIP, Pooled PBO||0.86|-2.24|
71113845|NCT02712983|141735136|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.1|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-2.61|0.4||||||Day 169: Pooled TIP/PBO, Pooled PBO||0.40|-2.61|
71113846|NCT02712983|141735137|OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.14|3.18|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort A: TIP, Pooled PBO||3.18|0.14|
71113847|NCT02712983|141735137|OTHER||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.18|1.85|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort A: TIP/PBO, Pooled PBO||1.85|0.18|
71113848|NCT02712983|141735137|OTHER||Hazard Ratio (HR)|1.26|||||TWO_SIDED|95.0|0.42|3.77|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort B: TIP, Pooled PBO||3.77|0.42|
71113849|NCT02712983|141735137|OTHER||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.2|1.83|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort B: TIP/PBO, Pooled PBO||1.83|0.20|
71113850|NCT02712983|141735137|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.21|2.17|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort C: TIP, Pooled PBO||2.17|0.21|
71113851|NCT02712983|141735137|OTHER||Hazard Ratio (HR)|1.27|||||TWO_SIDED|95.0|0.44|3.62|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort C: TIP/PBO, Pooled PBO||3.62|0.44|
71113852|NCT02712983|141735137|OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.44|2.23|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Pooled TIP, Pooled PBO||2.23|0.44|
71070806|NCT04594941|141650466|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 3||||<0.0001
71070807|NCT04594941|141650466|OTHER|||||||0.0072|||||||Wilcoxon Signed Rank Test|||Reader 1||||0.0072
71070808|NCT04594941|141650466|OTHER|||||||0.0051|||||||Wilcoxon Signed Rank Test|||Reader 2||||0.0051
71070809|NCT04594941|141650466|OTHER|||||||0.0023|||||||Wilcoxon Signed Rank Test|||Reader 3||||0.0023
71113853|NCT02712983|141735137|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.34|1.71|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Pooled TIP/PBO, Pooled PBO||1.71|0.34|
70939198|NCT03557307|141379269|OTHER||percentage|64.0|||||TWO_SIDED|95.0|60.06|67.9|||Clopper-Pearson Exact CI|One sample Confidence Interval (≥90% reduction)|Percentage of patients who achieve \>=90% reduction in daily OCS dose that are sustained over at least 4 weeks without worsening of asthma|||67.90|60.06|
71070810|NCT04594941|141650466|OTHER|||||||0.0002|||||||Wilcoxon Signed Rank Test|||Reader 1||||0.0002
71070811|NCT04594941|141650466|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 2||||<0.0001
71070812|NCT04594941|141650466|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 3||||<0.0001
71070813|NCT04594941|141650467|OTHER|||||||0.0089|||||||Wilcoxon Signed Rank Test|||Reader 1||||0.0089
71070814|NCT04594941|141650467|OTHER|||||||0.0207|||||||Wilcoxon Signed Rank Test|||Reader 2||||0.0207
71070815|NCT04594941|141650467|OTHER|||||||0.0089|||||||Wilcoxon Signed Rank Test|||Reader 3||||0.0089
71070816|NCT04594941|141650467|OTHER|||||||0.732|||||||Wilcoxon Signed Rank Test|||Reader 1||||0.732
71070817|NCT04594941|141650467|OTHER|||||||0.0083|||||||Wilcoxon Signed Rank Test|||Reader 2||||0.0083
71070818|NCT04594941|141650467|OTHER|||||||0.0412|||||||Wilcoxon (Mann-Whitney)|||Reader 3||||0.0412
71070819|NCT04594941|141650467|OTHER|||||||0.0001|||||||Wilcoxon Signed Rank Test|||Reader 1||||0.0001
71070820|NCT04594941|141650467|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 2||||<0.0001
71070821|NCT04594941|141650467|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 3||||<0.0001
70939199|NCT03557307|141379269|OTHER||percentage|68.9|||||TWO_SIDED|95.0|65.02|72.59|||Clopper-Pearson Exact CI|One sample Confidence Interval (\>=75% reduction)|Percentage of patients who achieve \>=75% reduction in daily OCS dose that are sustained over at least 4 weeks without worsening of asthma|||72.59|65.02|
71070822|NCT04594941|141650469|OTHER||Kappa Statistics|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 1||1.0000|1.0000|
71070823|NCT04594941|141650469|OTHER||Kappa Statistics|0.6957|||||TWO_SIDED|95.0|0.1696|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 2||1.0000|0.1696|
71070824|NCT04594941|141650469|OTHER||Kappa Statistics|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 3||1.0000|1.0000|
71070825|NCT04594941|141650469|OTHER||Kappa Statistics|0.4615|||||TWO_SIDED|95.0|-0.0699|0.993|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 1||0.9930|-0.0699|
71070826|NCT04594941|141650469|OTHER||Kappa Statistics|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 2||1.0000|1.0000|
71070827|NCT04594941|141650469|OTHER||Kappa Statistics|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 3||1.0000|1.0000|
71070828|NCT04594941|141650469|OTHER||Kappa Statistics|0.8811|||||TWO_SIDED|95.0|0.6567|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 1||1.0000|0.6567|
71070829|NCT04594941|141650469|OTHER||Kappa Statistics|0.8828|||||TWO_SIDED|95.0|0.6614|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 2||1.0000|0.6614|
71070830|NCT04594941|141650469|OTHER||Kappa Statistics|0.8811|||||TWO_SIDED|95.0|0.6567|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 3||1.0000|0.6567|
71070831|NCT03535194|141650476|SUPERIORITY||Risk Difference (RD)|73.5|||<|0.001|TWO_SIDED|95.0|68.2|78.7|||Cochran-Mantel-Haenszel|||||78.7|68.2|<0.001
71070832|NCT03535194|141650477|SUPERIORITY||Risk Difference (RD)|68.0|||<|0.001|TWO_SIDED|95.0|62.7|73.3|||Cochran-Mantel-Haenszel|||||73.3|62.7|<0.001
71070833|NCT03535194|141650478|SUPERIORITY||Risk Difference (RD)|81.6|||<|0.001|TWO_SIDED|95.0|76.1|87.0|||Cochran-Mantel-Haenszel|||||87.0|76.1|<0.001
71070834|NCT03535194|141650479|SUPERIORITY||Risk Difference (RD)|51.7|||<|0.001|TWO_SIDED|95.0|47.6|55.8|||Cochran-Mantel-Haenszel|||||55.8|47.6|<0.001
71070835|NCT03535194|141650480|SUPERIORITY||Risk Difference (RD)|23.2|||<|0.001|TWO_SIDED|95.0|19.3|27.1|||Cochran-Mantel-Haenszel|||||27.1|19.3|<0.001
71070836|NCT03535194|141650481|SUPERIORITY||Risk Difference (RD)|53.5|||<|0.001|TWO_SIDED|95.0|47.7|59.3|||Cochran-Mantel-Haenszel|||||59.3|47.7|<0.001
71070837|NCT03535194|141650482|SUPERIORITY||LSMean Difference|-4.94|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED|95.0|-7.01|-2.88|||Mixed Models Analysis|||||-2.88|-7.01|<0.001
71070838|NCT03535194|141650483|SUPERIORITY||LSMean Difference|-15.15|STANDARD_ERROR_OF_MEAN|0.692|<|0.001|TWO_SIDED|95.0|-16.51|-13.8|||Mixed Models Analysis|||||-13.80|-16.51|<0.001
71070839|NCT03535194|141650484|SUPERIORITY||LSMean Difference|-9.59|STANDARD_ERROR_OF_MEAN|1.55|<|0.001|TWO_SIDED|95.0|-12.63|-6.55|||Mixed Models Analysis|||||-6.55|-12.63|<0.001
71070840|NCT03535194|141650485|SUPERIORITY||LSMean Difference|3.46|STANDARD_ERROR_OF_MEAN|0.642|<|0.001|TWO_SIDED|95.0|2.2|4.72|||ANCOVA|||||4.72|2.20|<0.001
71070841|NCT03535194|141650486|SUPERIORITY||LSMean Difference|3.96|STANDARD_ERROR_OF_MEAN|0.711|<|0.001|TWO_SIDED|95.0|2.56|5.35|||ANCOVA|||||5.35|2.56|<0.001
71070842|NCT03535194|141650487|SUPERIORITY||Risk Difference (RD)|65.0|||<|0.001|TWO_SIDED|95.0|59.3|70.8|||Cochran-Mantel-Haenszel|||||70.8|59.3|<0.001
71070843|NCT03535194|141650489|SUPERIORITY||LSMean Difference|-0.5|STANDARD_ERROR_OF_MEAN|2.255||0.826|TWO_SIDED|95.0|-4.96|3.96|||ANCOVA|||||3.96|-4.96|0.826
71070844|NCT03535194|141650491|NON_INFERIORITY|10% non-inferiority margin was used.|Risk Difference (RD)|3.3|||<|0.0001|TWO_SIDED|95.0|-1.4|7.9|||Cochran-Mantel-Haenszel|||||7.9|-1.4|<0.0001
71070845|NCT03535194|141650492|NON_INFERIORITY|10% non-inferiority margin was used.|Risk Difference (RD)|1.6|||<|0.0001|TWO_SIDED|95.0|-3.4|6.6|||Cochran-Mantel-Haenszel|||||6.6|-3.4|<0.0001
71070846|NCT02091375|141650549|SUPERIORITY||Median Difference (Final Values)|-22.79||||0.0123|TWO_SIDED|95.0|-41.06|-5.43|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach.|||-5.43|-41.06|0.0123
71070847|NCT02091375|141650550|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0784|TWO_SIDED|95.0|0.93|4.3|||Cochran-Mantel-Haenszel|Stratified by age group (2-5 years, 6-12 years, and 13-18 years).||||4.30|0.93|0.0784
71070848|NCT05010512|141650576|NON_INFERIORITY|Noninferiority in distance VA was declared if the least squares means difference upper confidence limit was less than 0.05.|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.004|||ONE_SIDED|95.0||0.01||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with terms for lens, period and sequence as fixed effects, subject as a random effect. Difference = DT1 minus Infuse|||0.01||
71113854|NCT02712983|141735137|OTHER||Hazard Ratio (HR)|0.39|||||TWO_SIDED|95.0|0.08|1.83|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort A: TIP, Pooled PBO||1.83|0.08|
71113855|NCT02712983|141735137|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.25|2.89|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort A: TIP/PBO, Pooled PBO||2.89|0.25|
71113856|NCT02712983|141735137|OTHER||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.25|3.93|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort B: TIP, Pooled PBO||3.93|0.25|
71113857|NCT02712983|141735137|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.19|2.36|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort B: TIP/PBO, Pooled PBO||2.36|0.19|
71113858|NCT02712983|141735137|OTHER||Hazard Ratio (HR)|0.19|||||TWO_SIDED|95.0|0.02|1.57|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort C: TIP, Pooled PBO||1.57|0.02|
71113859|NCT02712983|141735137|OTHER||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.16|2.41|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort C: TIP/PBO, Pooled PBO||2.41|0.16|
71113860|NCT02712983|141735137|OTHER||Hazard Ratio (HR)|0.42|||||TWO_SIDED|95.0|0.13|1.31|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Pooled TIP, Pooled PBO||1.31|0.13|
71113861|NCT02712983|141735137|OTHER||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.28|1.8|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Pooled TIP/PBO, Pooled PBO||1.80|0.28|
70939200|NCT03557307|141379269|OTHER||percentage|81.8|||||TWO_SIDED|95.0|78.44|84.79|||Clopper-Pearson Exact CI|One sample Confidence Interval (\>=50% reduction)|Percentage of patients who achieve \>=50% reduction in daily OCS dose that are sustained over at least 4 weeks without worsening of asthma|||84.79|78.44|
70939201|NCT03557307|141379270|OTHER||percentage change from baseline|-76.92|||||TWO_SIDED|95.0|-79.9|-73.94|||Clopper-Pearson Exact CI|One sample Confidence Interval|Percentage change from baseline in daily OCS dose at the end of OCS reduction phase|||-73.94|-79.90|
70939202|NCT03184519|141379283|SUPERIORITY||Area Under Curve|0.79||||0.025|ONE_SIDED||||||t-test, 1 sided|||||||0.025
70939203|NCT04239911|141379287|EQUIVALENCE|A p\<0.05 considered the threshold for statistical significance.|Odds Ratio (OR)|0.97||||0.974|TWO_SIDED|95.0|0.14|6.85|||Regression, Logistic||The comparison group is enhanced usual care arm|"Outcome measures workers' intentions of leaving their current job. Responses included 7-point likert scale of very strongly disagree-very strongly agree. Dichotomized into agree, strongly agree, and very strongly vs. other responses. We used logistic mixed regression model to compare outcome between and within study arm. Mixed effects included a variable for time point (baseline/90 days), indicator for study arm, a study arm by time point interaction and subject random intercept."||6.85|0.14|0.974
71113862|NCT02712983|141735137|OTHER||Hazard Ratio (HR)|10.71|||||TWO_SIDED|95.0|1.1|104.19|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort A: TIP, Pooled PBO||104.19|1.10|
71113863|NCT02712983|141735137|OTHER||Hazard Ratio (HR)|4.62|||||TWO_SIDED|95.0|0.41|52.29|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort B: TIP, Pooled PBO||52.29|0.41|
71113864|NCT02712983|141735137|OTHER||Hazard Ratio (HR)|3.23|||||TWO_SIDED|95.0|0.28|37.06|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort B: TIP/PBO, Pooled PBO||37.06|0.28|
71113865|NCT02712983|141735137|OTHER||Hazard Ratio (HR)|1.61|||||TWO_SIDED|95.0|0.1|25.94|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort C: TIP, Pooled PBO||25.94|0.10|
71113866|NCT02712983|141735137|OTHER||Hazard Ratio (HR)|11.3|||||TWO_SIDED|95.0|1.09|117.34|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort C: TIP/PBO, Pooled PBO||117.34|1.09|
71113867|NCT02712983|141735137|OTHER||Hazard Ratio (HR)|4.3|||||TWO_SIDED|95.0|0.5|37.32|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Pooled TIP, Pooled PBO||37.32|0.50|
71113868|NCT02712983|141735138|OTHER||LS Mean Diff (SE) vs pooled placebo|9.8|STANDARD_ERROR_OF_MEAN|18.15|||TWO_SIDED|95.0|-27.15|46.81|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Cohort A: TIP, Pooled PBO||46.81|-27.15|
70852876|NCT00535288|141194582|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.07||||0.02|TWO_SIDED|95.0|-0.14|-0.01||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||-0.01|-0.14|0.02
70852877|NCT00745849|141194591|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||0.45
71070849|NCT02122770|141650577|SUPERIORITY||Geometric LS Mean Ratio|98.75|||||TWO_SIDED|90.0|82.6|118.05||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric least square (LS) means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||118.05|82.60|
71070850|NCT02122770|141650578|SUPERIORITY||Geometric LS Mean Ratio|110.21|||||TWO_SIDED|90.0|102.34|118.69||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||118.69|102.34|
71070851|NCT02122770|141650579|SUPERIORITY||Geometric LS Mean Ratio|110.66|||||TWO_SIDED|90.0|102.53|119.43||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||119.43|102.53|
71070852|NCT02122770|141650580|SUPERIORITY||Geometric LS Mean Ratio|113.05|||||TWO_SIDED|90.0|85.35|149.74||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||149.74|85.35|
71070853|NCT02122770|141650580|SUPERIORITY||Geometric LS Mean Ratio|159.55|||||TWO_SIDED|90.0|89.97|282.96||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference||282.96|89.97|
71070854|NCT02122770|141650580|SUPERIORITY||Geometric LS Mean Ratio|77.26|||||TWO_SIDED|90.0|55.19|108.17||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||108.17|55.19|
71070855|NCT02122770|141650581|SUPERIORITY||Geometric LS Mean Ratio|121.57|||||TWO_SIDED|90.0|110.92|133.24||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||133.24|110.92|
71070856|NCT02122770|141650581|SUPERIORITY||Geometric LS Mean Ratio|130.16|||||TWO_SIDED|90.0|106.99|158.35||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference||158.35|106.99|
71070857|NCT02122770|141650581|SUPERIORITY||Geometric LS Mean Ratio|101.36|||||TWO_SIDED|90.0|90.72|113.23||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||113.23|90.72|
71070858|NCT02122770|141650582|SUPERIORITY||Geometric LS Mean Ratio|122.95|||||TWO_SIDED|90.0|112.13|134.82||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||134.82|112.13|
71070859|NCT02122770|141650582|SUPERIORITY||Geometric LS Mean Ratio|130.16|||||TWO_SIDED|90.0|106.99|158.35||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference||158.35|106.99|
71070860|NCT02122770|141650582|SUPERIORITY||Geometric LS Mean Ratio|100.89|||||TWO_SIDED|90.0|91.14|111.68||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||111.68|91.14|
71113869|NCT02712983|141735138|OTHER||LS Mean Diff (SE) vs pooled placebo|19.8|STANDARD_ERROR_OF_MEAN|20.81|||TWO_SIDED|95.0|-22.63|62.14|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Cohort A: TIP/PBO, Pooled PBO||62.14|-22.63|
71113870|NCT02712983|141735138|OTHER||LS Mean Diff (SE) vs pooled placebo|8.0|STANDARD_ERROR_OF_MEAN|19.29|||TWO_SIDED|95.0|-31.32|47.26|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Cohort B: TIP, Pooled PBO||47.26|-31.32|
71113871|NCT02712983|141735138|OTHER||LS Mean Diff (SE) vs pooled placebo|12.7|STANDARD_ERROR_OF_MEAN|19.24|||TWO_SIDED|95.0|-26.49|51.89|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Cohort B: TIP/PBO, Pooled PBO||51.89|-26.49|
71113872|NCT02712983|141735138|OTHER||LS Mean Diff (SE) vs pooled placebo|46.5|STANDARD_ERROR_OF_MEAN|21.17|||TWO_SIDED|95.0|3.37|89.61|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Cohort C: TIP, Pooled PBO||89.61|3.37|
71113873|NCT02712983|141735138|OTHER||LS Mean Diff (SE) vs pooled placebo|3.2|STANDARD_ERROR_OF_MEAN|18.37|||TWO_SIDED|95.0|-34.21|40.64|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Cohort C: TIP/PBO, Pooled PBO||40.64|-34.21|
70852878|NCT01129583|141194592|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||t-test, 2 sided|||||||0.06
70852879|NCT01129583|141194593|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||||||0.01
70852880|NCT01129583|141194594|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||||||0.02
70852881|NCT02600871|141194595|SUPERIORITY|The significance of variation in proportions with treatment (Provodine®, Control) was assessed with Fisher's Exact tests and variation in the mean with treatment was assessed with T-tests.||||||0.71|||||||Fisher Exact|||||||0.71
71113874|NCT02712983|141735138|OTHER||LS Mean Diff (SE) vs pooled placebo|21.4|STANDARD_ERROR_OF_MEAN|14.46|||TWO_SIDED|95.0|-8.03|50.89|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Pooled TIP, Pooled PBO||50.89|-8.03|
71113875|NCT02712983|141735138|OTHER||LS Mean Diff (SE) vs pooled placebo|11.9|STANDARD_ERROR_OF_MEAN|14.44|||TWO_SIDED|95.0|-17.52|41.29|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Pooled TIP/PBO, Pooled PBO||41.29|-17.52|
71113876|NCT02712983|141735143|OTHER||Hazard Ratio (HR)|1.26|||||TWO_SIDED|95.0|0.51|3.13|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort A: TIP, Pooled PBO||3.13|0.51|
70939204|NCT04239911|141379287|EQUIVALENCE|A p\< 0.05 considered the threshold for statistical significance|Odds Ratio (OR)|0.8||||0.846|TWO_SIDED|95.0|0.08|7.72|||Regression, Logistic||The comparison group is enhanced usual care arm|"Outcome measures workers' intentions of searching for a new job. Responses included 7-point likert scale of very strongly disagree-very strongly agree. Dichotomized into agree, strongly agree, and very strongly vs. other responses. We used logistic mixed regression model to compare outcome between and within study arm. Mixed effects included a variable for time point (baseline/90 days), indicator for study arm, a study arm by time point interaction and subject random intercept."||7.72|0.08|0.846
71113877|NCT02712983|141735143|OTHER||Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.15|1.46|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort A: TIP/PBO, Pooled PBO||1.46|0.15|
71113878|NCT02712983|141735143|OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.44|3.21|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort B: TIP, Pooled PBO||3.21|0.44|
71113879|NCT02712983|141735143|OTHER||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.32|2.18|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort B: TIP/PBO, Pooled PBO||2.18|0.32|
71113880|NCT02712983|141735143|OTHER||Hazard Ratio (HR)|0.35|||||TWO_SIDED|95.0|0.1|1.27|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort C: TIP, Pooled PBO||1.27|0.10|
71113881|NCT02712983|141735143|OTHER||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.43|2.99|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort C: TIP/PBO, Pooled PBO||2.99|0.43|
71113882|NCT02712983|141735143|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.37|1.76|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Pooled TIP, Pooled PBO||1.76|0.37|
70939205|NCT04239911|141379290|EQUIVALENCE|A p\<0.05 was considered the threshold for statistical significance.|Odds Ratio (OR)|0.18||||0.043|TWO_SIDED|95.0|0.03|0.94|||Regression, Logistic||The comparison group is enhanced usual care arm|"Preventable 911 calls if had been able to reach the doctor. Dichotomized into agree, strongly agree, and very strongly vs. all other responses. We used logistic mixed regression model to compare trajectory of all outcomes between and within study arms. Mixed effects included a fixed effects categorical variable for time point (baseline/90days), and indicator for study arm (enhanced usual care/intervention), a study arm by time point interaction and subject specific random intercept."||0.94|0.03|0.043
71113883|NCT02712983|141735143|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.36|1.61|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Pooled TIP/PBO, Pooled PBO||1.61|0.36|
71113884|NCT02712983|141735143|OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.3|2.55|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort A: TIP, Pooled PBO||2.55|0.30|
71113885|NCT02712983|141735143|OTHER||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.2|2.03|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort A: TIP/PBO, Pooled PBO||2.03|0.20|
71113886|NCT02712983|141735143|OTHER||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.4|3.6|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort B: TIP, Pooled PBO||3.60|0.40|
71113887|NCT02712983|141735143|OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.31|2.55|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort B: TIP/PBO, Pooled PBO||2.55|0.31|
71113888|NCT02712983|141735143|OTHER||Hazard Ratio (HR)|0.28|||||TWO_SIDED|95.0|0.06|1.27|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort C: TIP, Pooled PBO||1.27|0.06|
71113889|NCT02712983|141735143|OTHER||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.45|3.73|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort C: TIP/PBO, Pooled PBO||3.73|0.45|
71113890|NCT02712983|141735143|OTHER||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.27|1.6|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Pooled TIP, Pooled PBO||1.60|0.27|
71113891|NCT02712983|141735143|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.4|2.02|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Pooled TIP/PBO, Pooled PBO||2.02|0.40|
70939206|NCT04239911|141379290|EQUIVALENCE|A p\<0.05 considered the threshold for statistical significance.|Odds Ratio (OR)|1.01||||0.99|TWO_SIDED|95.0|0.22|4.58|||Regression, Logistic|||"Preventable 911 calls if had been able to reach the nurse/supervisor. Dichotomized into agree, strongly agree, and very strongly vs. other responses. We used logistic mixed regression model to compare trajectory of all outcomes between and within study arms. Mixed effects included a fixed effects categorical variable for time point (baseline/90days), and indicator for study arm (enhanced usual care/intervention), a study arm by time point interaction and subject specific random intercept."||4.58|0.22|0.99
70939207|NCT01580306|141379291|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|113.57|STANDARD_DEVIATION|93.2|||TWO_SIDED|90.0|41.58|310.17|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison mild : normal||310.17|41.58|
70939208|NCT01580306|141379291|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|178.31|STANDARD_DEVIATION|78.9|||TWO_SIDED|90.0|85.23|373.03|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison moderate : normal||373.03|85.23|
70939209|NCT01580306|141379291|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|169.21|STANDARD_DEVIATION|97.7|||TWO_SIDED|90.0|73.19|391.17|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison severe : normal||391.17|73.19|
70939210|NCT01580306|141379292|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|107.22|STANDARD_DEVIATION|107.7|||TWO_SIDED|90.0|35.16|327.01|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison mild : normal||327.01|35.16|
70939211|NCT01580306|141379292|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|175.52|STANDARD_DEVIATION|70.4|||TWO_SIDED|90.0|89.55|344.06|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison moderate : normal||344.06|89.55|
70939212|NCT01580306|141379292|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|120.98|STANDARD_DEVIATION|115.0|||TWO_SIDED|90.0|47.257|309.736|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison severe : normal||309.736|47.257|
71070861|NCT00535847|141650618|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.703|||||TWO_SIDED|95.0|4.259|37.884||||||Stratified Analysis (Mantel-Haenszel)- The Mantel-Haenszel estimator provides an estimate of the common odds ratio for the association between eRVR and SVR across the prior response strata.||37.884|4.259|
70939213|NCT03345407|141379309|OTHER||Posterior adjusted median difference|-0.022|||||TWO_SIDED|95.0|-0.143|0.103|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 12.5 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.|||0.103|-0.143|
71070862|NCT00373958|141650633|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-3.6||||||95.0|-7.3|-0.1||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||-0.1|-7.3|
70939214|NCT03345407|141379309|OTHER||Posterior adjusted median difference|-0.027|||||TWO_SIDED|95.0|-0.098|0.036|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 50 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.|||0.036|-0.098|
70939215|NCT03345407|141379309|OTHER||Posterior adjusted median difference|-0.038|||||TWO_SIDED|95.0|-0.102|0.028|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 100 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.|||0.028|-0.102|
71113892|NCT02712983|141735143|OTHER||Hazard Ratio (HR)|3.72|||||TWO_SIDED|95.0|0.84|16.52|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort A: TIP, Pooled PBO||16.52|0.84|
71113893|NCT02712983|141735143|OTHER||Hazard Ratio (HR)|1.34|||||TWO_SIDED|95.0|0.22|8.16|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort B: TIP, Pooled PBO||8.16|0.22|
71113894|NCT02712983|141735143|OTHER||Hazard Ratio (HR)|2.15|||||TWO_SIDED|95.0|0.46|10.05|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort B: TIP/PBO, Pooled PBO||10.05|0.46|
71113895|NCT02712983|141735143|OTHER||Hazard Ratio (HR)|0.5|||||TWO_SIDED|95.0|0.05|4.87|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort C: TIP, Pooled PBO||4.87|0.05|
71113896|NCT02712983|141735143|OTHER||Hazard Ratio (HR)|2.56|||||TWO_SIDED|95.0|0.53|12.49|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort C: TIP/PBO, Pooled PBO||12.49|0.53|
70939216|NCT03345407|141379309|OTHER||Posterior adjusted median difference|0.005|||||TWO_SIDED|95.0|-0.064|0.071|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 250 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.|||0.071|-0.064|
70939217|NCT03345407|141379309|OTHER||Posterior adjusted median difference|-0.003|||||TWO_SIDED|95.0|-0.075|0.061|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 500 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.|||0.061|-0.075|
70939218|NCT03345407|141379309|OTHER||Posterior adjusted median difference|-0.004|||||TWO_SIDED|95.0|-0.051|0.042|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 750 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.|||0.042|-0.051|
71070863|NCT00373958|141650633|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-5.5||||||95.0|-10.9|-0.1||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||-0.1|-10.9|
71113897|NCT02712983|141735143|OTHER||Hazard Ratio (HR)|1.36|||||TWO_SIDED|95.0|0.33|5.68|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Paremteral Pooled TIP, Pooled PBO||5.68|0.33|
71113898|NCT02712983|141735148|OTHER||Odds Ratio, log|5.62|||||TWO_SIDED|95.0|0.83|38.18|||||Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.|Cohort A (3 capsules o.d.): TIP, Pooled PBO||38.18|0.83|
71113899|NCT02712983|141735148|OTHER||Odds Ratio, log|2.0|||||TWO_SIDED|95.0|0.21|19.16|||||Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.|Cohort B (5 capsules o.d.): TIP, Pooled PBO||19.16|0.21|
71113900|NCT02712983|141735148|OTHER||Odds Ratio, log|3.05|||||TWO_SIDED|95.0|0.43|21.8|||||Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.|Cohort B (5 capsules o.d.): TIP/PBO, Pooled PBO||21.80|0.43|
70939219|NCT03345407|141379310|OTHER||Posterior median exacerbation rate ratio|0.92|||||TWO_SIDED|95.0|0.6|1.4|||||Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 50 mcg and placebo for moderate/severe exacerbations has been presented.|||1.40|0.60|
71070864|NCT00373958|141650633|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-7.9||||||95.0|-12.4|-4.0||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||-4.0|-12.4|
71070865|NCT00373958|141650633|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.4||||||95.0|-2.7|3.5||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.5|-2.7|
71070866|NCT00373958|141650633|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-1.6||||||95.0|-4.7|1.2||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.2|-4.7|
71070867|NCT00373958|141650633|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.4||||||95.0|-2.4|3.4||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.4|-2.4|
71070868|NCT00373958|141650633|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-3.6||||||95.0|-8.5|1.2||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.2|-8.5|
71113901|NCT02712983|141735148|OTHER||Odds Ratio, log|1.84|||||TWO_SIDED|95.0|0.19|17.42|||||Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.|Cohort C (4 capsules b.i.d.): TIP, Pooled PBO||17.42|0.19|
71113902|NCT02712983|141735148|OTHER||Odds Ratio, log|3.41|||||TWO_SIDED|95.0|0.47|25.03|||||Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.|Cohort C (4 capsules b.i.d.): TIP/PBO, Pooled PBO||25.03|0.47|
71113903|NCT02712983|141735148|OTHER||Odds Ratio, log|2.74|||||TWO_SIDED|95.0|0.47|16.07|||||Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.|||16.07|0.47|
71113904|NCT02712983|141735149|OTHER||Hazard Ratio (HR)|4.5|||||TWO_SIDED|95.0|0.77|26.42|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Cohort A (3 capsules o.d.): TIP, Pooled PBO||26.42|0.77|
71070869|NCT00373958|141650634|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.68||||||95.0|0.57|0.8||||||For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated||0.80|0.57|
71113905|NCT02712983|141735149|OTHER||Hazard Ratio (HR)|2.0|||||TWO_SIDED|95.0|0.28|14.47|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Cohort B (5 capsules o.d.): TIP, Pooled PBO||14.47|0.28|
71113906|NCT02712983|141735149|OTHER||Hazard Ratio (HR)|1.54|||||TWO_SIDED|95.0|0.2|11.6|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Cohort B (5 capsules o.d.): TIP/PBO, Pooled PBO||11.60|0.20|
70852882|NCT03745820|141194613|SUPERIORITY||Least Squares (LS) Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|1.328|=|0.8472|TWO_SIDED|95.0|-2.88|2.37|||MMRM|||Mixed Model Repeated Measures(MMRM)model was used to analyze change from baseline of outcome measure(OM)using fixed effects of treatment group,region,study visit,study visit-by-treatment interaction,baseline value of OM,baseline-by-visit interaction.||2.37|-2.88|=0.8472
71070870|NCT00373958|141650634|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.74||||||95.0|0.61|0.89||||||For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated||0.89|0.61|
71070871|NCT00373958|141650634|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.72||||||95.0|0.62|0.85||||||For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated||0.85|0.62|
71070872|NCT00373958|141650634|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.72||||||95.0|0.6|0.86||||||For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated||0.86|0.60|
70939220|NCT03345407|141379310|OTHER||Posterior median exacerbation rate ratio|0.89|||||TWO_SIDED|95.0|0.57|1.35|||||Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 100 mcg and placebo for moderate/severe exacerbations has been presented.|||1.35|0.57|
70939221|NCT03345407|141379310|OTHER||Posterior median exacerbation rate ratio|1.01|||||TWO_SIDED|95.0|0.65|1.5|||||Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 250 mcg and placebo for moderate/severe exacerbations has been presented.|||1.50|0.65|
70939222|NCT03345407|141379310|OTHER||Posterior median exacerbation rate ratio|0.63|||||TWO_SIDED|95.0|0.37|1.02|||||Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 500 mcg and placebo for moderate/severe exacerbations has been presented.|||1.02|0.37|
70939223|NCT03345407|141379310|OTHER||Posterior median exacerbation rate ratio|1.13|||||TWO_SIDED|95.0|0.85|1.52|||||Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 750 mcg and placebo for moderate/severe exacerbations has been presented.|||1.52|0.85|
71070873|NCT00373958|141650634|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.68||||||95.0|0.57|0.81||||||For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated||0.81|0.57|
71070874|NCT00373958|141650634|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|1.18||||||95.0|0.98|1.41||||||For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated||1.41|0.98|
71070875|NCT00373958|141650634|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.65||||||95.0|0.54|0.78||||||For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated||0.78|0.54|
71070876|NCT00373958|141650635|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \> -10%.|Difference|0.1||||||95.0|-2.9|3.1||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15μg/mL threshold was calculated.||3.1|-2.9|
71070877|NCT00373958|141650635|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \> -10%.|Difference|-0.6||||||95.0|-8.3|7.0||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 μg/mL threshold was calculated.||7.0|-8.3|
71070878|NCT00373958|141650635|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \> -10%.|Difference|-0.4||||||95.0|-4.3|3.5||||||For diphtheria toxoid the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.||3.5|-4.3|
71070879|NCT00373958|141650635|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \> -10%.|Difference|1.7||||||95.0|-2.1|5.6||||||For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 40.5 EU/mL threshold was calculated.||5.6|-2.1|
71070880|NCT00373958|141650635|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \> -10%.|Difference|-0.9||||||95.0|-5.2|3.4||||||For Pertussis PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 16.5 EU/mL threshold was calculated.||3.4|-5.2|
71070881|NCT00373958|141650635|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \> -10%.|Difference|-2.1||||||95.0|-6.4|2.0||||||For Pertussis PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 26 EU/mL threshold was calculated.||2.0|-6.4|
71070882|NCT00373958|141650636|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.6|1.7||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15μg/mL threshold was calculated.||1.7|-1.6|
71070883|NCT00373958|141650636|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.6||||||95.0|-7.1|3.8||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0μg/mL threshold was calculated.||3.8|-7.1|
71070884|NCT00373958|141650636|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -5%.|Difference|-0.8||||||95.0|-4.5|2.9||||||For Measles the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1.10 I.V. threshold was calculated.||2.9|-4.5|
71070885|NCT00373958|141650636|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -5%.|Difference|3.6||||||95.0|-4.7|11.9||||||For Mumps the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1.10 I.V. threshold was calculated.||11.9|-4.7|
71070886|NCT00373958|141650636|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -5%.|Difference|1.2||||||95.0|-4.4|6.9||||||For Rubella the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥15 IU/mL threshold was calculated.||6.9|-4.4|
71079399|NCT00482170|141666420|SUPERIORITY_OR_OTHER||Regression coefficient|-0.09||||0.707|TWO_SIDED|95.0|-0.58|0.39||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, female and male (reference).||0.39|-0.58|0.707
70939224|NCT03345407|141379311|OTHER||Posterior median hazard ratio|0.455|||||TWO_SIDED|95.0|0.054|1.103|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 12.5 mcg and placebo for time to next moderate/severe exacerbations has been presented.|||1.103|0.054|
70939225|NCT03345407|141379311|OTHER||Posterior median hazard ratio|0.991|||||TWO_SIDED|95.0|0.58|1.5|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 50 mcg and placebo for time to next moderate/severe exacerbations has been presented.|||1.500|0.580|
70939226|NCT03345407|141379311|OTHER||Posterior median hazard ratio|0.975|||||TWO_SIDED|95.0|0.581|1.467|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 100 mcg and placebo for time to next moderate/severe exacerbations has been presented.|||1.467|0.581|
71070887|NCT00373958|141650636|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|4.8||||||95.0|-3.4|13.0||||||For Varicella the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1.09 I.V. threshold was calculated.||13.0|-3.4|
71070888|NCT00373958|141650637|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.94||||||95.0|0.75|1.17||||||For Haemophilus influenzae type b (PRP) the GMC ratio (13vPnC/7vPnC) was calculated||1.17|0.75|
71070889|NCT00373958|141650638|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.96|||||TWO_SIDED|95.0|0.85|1.08||||||For Measles the GMC ratio (13vPnC/7vPnC) was calculated||1.08|0.85|
71070890|NCT00373958|141650638|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.0|||||TWO_SIDED|95.0|0.87|1.14||||||For Mumps the GMC ratio (13vPnC/7vPnC) was calculated||1.14|0.87|
71070891|NCT00373958|141650638|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.01|||||TWO_SIDED|95.0|0.92|1.1||||||For Varicella the GMC ratio (13vPnC/7vPnC) was calculated||1.10|0.92|
71070892|NCT00373958|141650639|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.78|||||TWO_SIDED|95.0|0.62|1.0||||||For Rubella the GMC ratio (13vPnC/7vPnC) was calculated||1.00|0.62|
71113907|NCT02712983|141735149|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.06|7.49|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Cohort C (4 capsules b.i.d.): TIP, Pooled PBO||7.49|0.06|
71113908|NCT02712983|141735149|OTHER||Hazard Ratio (HR)|3.81|||||TWO_SIDED|95.0|0.62|23.29|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Cohort C (4 capsules b.i.d.): TIP/PBO, Pooled PBO||23.29|0.62|
71113909|NCT02712983|141735149|OTHER||Hazard Ratio (HR)|1.82|||||TWO_SIDED|95.0|0.35|9.45|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Pooled TIP, Pooled PBO||9.45|0.35|
71117697|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-10.71||||0.007|TWO_SIDED|95.0|-18.2|-3.21||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-3.21|-18.20|0.007
71070893|NCT05007041|141650644|NON_INFERIORITY|The one-sided non-inferiority test with the alpha level set at 0.025 and non-inferiority margin of 10%, stratified by site.|Difference in proportions|-0.96||||0.0037|TWO_SIDED|95.0|-8.94|7.1|||Difference in proportions|The upper bound of a site-stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.||The null hypothesis is simultaneous vaccination with RZV and allV4 is inferior (i.e., RZV and allV4 will have a higher proportion) to RZV and HD-IIV4 with regard to the proportion of adults with at least one severe (Grade 3) solicited local or systemic reactogenicity event on days 1-8 after RZV dose||7.10|-8.94|0.0037
71070894|NCT05007041|141650645|OTHER|Difference in proportions|Difference in proportions|-7.77|||||TWO_SIDED|95.0|-20.22|4.69||||||||4.69|-20.22|
70939227|NCT03345407|141379311|OTHER||Posterior median hazard ratio|1.132|||||TWO_SIDED|95.0|0.682|1.709|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 250 mcg and placebo for time to next moderate/severe exacerbations has been presented.|||1.709|0.682|
70939228|NCT03345407|141379311|OTHER||Posterior median hazard ratio|0.556|||||TWO_SIDED|95.0|0.268|0.902|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 500 mcg and placebo for time to next moderate/severe exacerbations has been presented.|||0.902|0.268|
71070895|NCT05007041|141650646|OTHER|Difference in proportions|Difference in proportions|2.59|||||TWO_SIDED|95.0|-7.29|12.47||||||||12.47|-7.29|
71070896|NCT05007041|141650647|NON_INFERIORITY|The one-sided non-inferiority test with the alpha level set at 0.025 and non-inferiority margin of 10%, stratified by site.|Difference in proportions|1.74||||0.0031|TWO_SIDED|95.0|-4.04|7.77||The upper bound of a site-stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Difference in proportions|||Number of Participants With at Least One Severe (Grade 3) Solicited Local Reactogenicity Event After SHINGRIX® Dose 1 in Each Study Group||7.77|-4.04|0.0031
70939229|NCT03345407|141379311|OTHER||Posterior median hazard ratio|1.149|||||TWO_SIDED|95.0|0.8|1.539|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 750 mcg and placebo for time to next moderate/severe exacerbations has been presented.|||1.539|0.800|
70939230|NCT03345407|141379314|OTHER||Posterior median odds ratio|1.01|||||TWO_SIDED|95.0|0.21|2.3|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.30|0.21|
71070897|NCT05007041|141650648|OTHER|Difference in proportions|Difference in proportions|-6.25|||||TWO_SIDED|95.0|-13.1|0.6|||Difference in proportions|||||0.60|-13.10|
70939231|NCT03345407|141379314|OTHER||Posterior median odds ratio|1.37|||||TWO_SIDED|95.0|0.76|2.17|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.17|0.76|
71070898|NCT05007041|141650649|OTHER|Difference in proportions|Difference in proportions|5.89|||||TWO_SIDED|95.0|-1.32|13.11|||Difference in proportions|||||13.11|-1.32|
71070899|NCT05007041|141650650|NON_INFERIORITY|The one-sided non-inferiority test with the alpha level set at 0.025 and non-inferiority margin of 10%, stratified by site.|Difference in proportions|-4.17|||<|0.0001|TWO_SIDED|95.0|-10.9|2.47|||Difference in proportions|The upper bound of a site-stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.||||2.47|-10.90|<0.0001
71070900|NCT05007041|141650651|OTHER|Difference in proportions|Difference in proportions|-5.68|||||TWO_SIDED|95.0|-17.64|6.28|||Difference in proportions|||||6.28|-17.64|
71070901|NCT05007041|141650652|OTHER|Difference in proportions|Difference in proportions|-3.3|||||TWO_SIDED|95.0|-10.5|3.89|||Difference in proportions|||||3.89|-10.50|
71070902|NCT05007041|141650653|OTHER|Difference in proportions|Difference in proportions|-0.73|||||TWO_SIDED|95.0|-2.16|0.7|||Difference in proportions|||||0.70|-2.16|
71070903|NCT05007041|141650654|OTHER|The proportion and 95% exact binomial confidence interval between vaccine groups.|Difference in proportions|-2.88|||||TWO_SIDED|95.0|-6.36|0.6|||Difference in proportions|||||0.60|-6.36|
71070904|NCT01552915|141650655|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-2.1|STANDARD_ERROR_OF_MEAN|1.15||0.0717|TWO_SIDED|95.0|-4.3|0.2|||mixed effects model for repeated measure|||||0.2|-4.3|0.0717
71070905|NCT01552915|141650655|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-12.2|STANDARD_ERROR_OF_MEAN|1.45|<|0.0001|TWO_SIDED|95.0|-15.1|-9.4|||mixed effects model for repeated measure|||||-9.4|-15.1|<0.0001
71070906|NCT01552915|141650655|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-10.1|STANDARD_ERROR_OF_MEAN|1.43|<|0.0001|TWO_SIDED|95.0|-13.0|-7.3|||mixed effects model for repeated measure|||||-7.3|-13.0|<0.0001
71070907|NCT01552915|141650656|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6165|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.6165
71070908|NCT01552915|141650656|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
71070909|NCT01552915|141650656|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
71070910|NCT03421145|141650673|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71070911|NCT03421145|141650674|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71070912|NCT03421145|141650675|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71117698|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-3.99||||0.385|TWO_SIDED|95.0|-12.86|4.88||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.88|-12.86|0.385
70939232|NCT03345407|141379314|OTHER||Posterior median odds ratio|0.99|||||TWO_SIDED|95.0|0.54|1.61|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.61|0.54|
71070913|NCT03421145|141650676|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71070914|NCT03421145|141650677|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71070915|NCT02951533|141650691|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71070916|NCT05870956|141650739|OTHER||Mean Difference (Net)|932.88||||0.516|TWO_SIDED|95.0|-1880.17|3745.94|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||3745.94|-1880.17|0.516
70939233|NCT03345407|141379314|OTHER||Posterior median odds ratio|0.94|||||TWO_SIDED|95.0|0.5|1.49|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.49|0.50|
71070917|NCT05870956|141650739|OTHER||Mean Difference (Net)|4902.02||||0.02|TWO_SIDED|95.0|767.6|9036.43|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||9036.43|767.60|0.020
71070918|NCT05870956|141650739|OTHER||Mean Difference (Net)|2727.38||||0.026|TWO_SIDED|95.0|323.48|5131.27|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||5131.27|323.48|0.026
71070919|NCT05870956|141650739|OTHER||Mean Difference (Net)|5462.41||||0|TWO_SIDED|95.0|2520.93|8403.9|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||8403.90|2520.93|0.000
71070920|NCT05870956|141650740|OTHER||Mean Difference (Net)|-303.94||||0.439|TWO_SIDED|95.0|-1074.77|466.9|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||466.90|-1074.77|0.439
71070921|NCT05870956|141650740|OTHER||Mean Difference (Net)|2772.06||||0.021|TWO_SIDED|95.0|422.1|5122.02|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||5122.02|422.10|0.021
71070922|NCT05870956|141650740|OTHER||Mean Difference (Net)|456.79||||0.328|TWO_SIDED|95.0|-458.64|1372.21|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||1372.21|-458.64|0.328
71070923|NCT05870956|141650740|OTHER||Mean Difference (Net)|620.87||||0.382|TWO_SIDED|95.0|-771.77|2013.51|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||2013.51|-771.77|0.382
71070924|NCT05870956|141650741|OTHER||Mean Difference (Net)|2.4||||0.463|TWO_SIDED|95.0|-4.0|8.9|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||8.9|-4.0|0.463
71070925|NCT05870956|141650741|OTHER||Mean Difference (Net)|9.6||||0.008|TWO_SIDED|95.0|2.5|16.8|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||16.8|2.5|0.008
71070926|NCT05870956|141650741|OTHER||Mean Difference (Net)|9.1||||0.005|TWO_SIDED|95.0|2.8|15.3|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||15.3|2.8|0.005
71070927|NCT05870956|141650741|OTHER||Mean Difference (Net)|6.4||||0.019|TWO_SIDED|95.0|1.1|11.7|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||11.7|1.1|0.019
71070928|NCT05870956|141650742|OTHER||Mean Difference (Net)|0.6||||0.801|TWO_SIDED|95.0|-4.3|5.5|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||5.5|-4.3|0.801
71070929|NCT05870956|141650742|OTHER||Mean Difference (Net)|8.7||||0.005|TWO_SIDED|95.0|2.7|14.8|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||14.8|2.7|0.005
71070930|NCT05870956|141650742|OTHER||Mean Difference (Net)|3.4||||0.17|TWO_SIDED|95.0|-1.4|8.2|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||8.2|-1.4|0.170
71070931|NCT05870956|141650742|OTHER||Mean Difference (Net)|1.4||||0.489|TWO_SIDED|95.0|-2.6|5.4|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||5.4|-2.6|0.489
71070932|NCT03724877|141650743|OTHER||Adjusted hazard ratio (HR)|1.04|||||TWO_SIDED|95.0|0.79|1.38|||Regression, Cox||After matching on high-dimensional propensity scores, sex prior severe exacerbation, prior maintenance treatment and calendar time, adjusted further for the deciles of propensity score and percent predicted forced expiratory volume1 (FEV1).|||1.38|0.79|
71070933|NCT03724877|141650744|OTHER||Adjusted HR|0.97|||||TWO_SIDED|95.0|0.87|1.09|||Regression, Cox||After matching on high-dimensional propensity scores, sex prior severe exacerbation, prior maintenance treatment and calendar time, adjusted further for the deciles of propensity score and percent predicted FEV1.|||1.09|0.87|
71070934|NCT03724877|141650745|OTHER||Adjusted HR|1.46|||||TWO_SIDED|95.0|1.03|2.07|||Regression, Cox||After matching on high-dimensional propensity scores, sex prior severe exacerbation, prior maintenance treatment and calendar time, adjusted further for the deciles of propensity score and percent predicted FEV1.|||2.07|1.03|
71070935|NCT03724877|141650746|OTHER||Adjusted rate ratio|0.93|||||TWO_SIDED|95.0|0.83|1.04|||Negative binomial regression model||After matching on high-dimensional propensity scores, sex prior severe exacerbation, prior maintenance treatment and calendar time, adjusted further for the deciles of propensity score and percent predicted FEV1.|Moderate/ sever exacerbation||1.04|0.83|
71070936|NCT03724877|141650746|OTHER||Adjusted rate ratio|0.94|||||TWO_SIDED|95.0|0.7|1.28|||Negative binomial regression model||After matching on high-dimensional propensity scores, sex prior severe exacerbation, prior maintenance treatment and calendar time, adjusted further for the deciles of propensity score and percent predicted FEV1.|Severe exacerbation||1.28|0.70|
71070937|NCT00742508|141650761|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.38|STANDARD_ERROR_OF_MEAN|5.449|||TWO_SIDED|95.0|-5.75|24.51|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the 24 h assessment.|||24.51|-5.75|
71113910|NCT05360966|141735160|OTHER|Difference (2-sided)|Difference in Percentages|38.8|||<|0.0001|TWO_SIDED|95.0|30.8|46.8||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|Pearson's Chi-squared test||Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|For binary endpoint, the underlying continuous measurement of unanesthetized Schirmer score was imputed, change score calculated and then dichotomized to ascertain attainment of greater than or equal to 10 millimeter increase from pre-drop baseline.|46.8|30.8|<0.0001
71070938|NCT00742508|141650761|SUPERIORITY_OR_OTHER||Median Difference (Net)|7.55|STANDARD_ERROR_OF_MEAN|5.849|||TWO_SIDED|95.0|-8.68|23.79|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Morning assessment.|||23.79|-8.68|
71070939|NCT00742508|141650761|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.92|STANDARD_ERROR_OF_MEAN|3.645|||TWO_SIDED|95.0|-12.04|8.2|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Afternoon assessment.|||8.20|-12.04|
71070940|NCT00742508|141650761|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.21|STANDARD_ERROR_OF_MEAN|6.361|||TWO_SIDED|95.0|-3.45|31.87|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Night assessment.|||31.87|-3.45|
71070941|NCT00742508|141650761|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|3.79|||TWO_SIDED|95.0|-10.12|10.92|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Waking assessment.|||10.92|-10.12|
71070942|NCT00742508|141650761|SUPERIORITY_OR_OTHER||Mean Difference (Net)|25.04|STANDARD_ERROR_OF_MEAN|4.281|||TWO_SIDED|95.0|13.16|36.93|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Sleeping assessment.|||36.93|13.16|
71070943|NCT00742508|141650761|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.45|STANDARD_ERROR_OF_MEAN|10.62||||95.0|-29.94|29.03|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmax assessment.|||29.03|-29.94|
71070944|NCT00742508|141650761|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.31|STANDARD_ERROR_OF_MEAN|7.194|||TWO_SIDED|95.0|-11.67|28.28|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmin assessment.|||28.28|-11.67|
71070945|NCT00742508|141650761|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.142|||TWO_SIDED|95.0|-0.63|0.15|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmax/PDmin assessment.|||0.15|-0.63|
71070946|NCT00742508|141650781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.21|STANDARD_ERROR_OF_MEAN|4.833|||TWO_SIDED|95.0|-11.2|15.63|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the 24 h assessment.|||15.63|-11.20|
71070947|NCT00742508|141650781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56|STANDARD_ERROR_OF_MEAN|6.265|||TWO_SIDED|95.0|-17.95|16.84|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Morning assessment.|||16.84|-17.95|
71070948|NCT00742508|141650781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.93|STANDARD_ERROR_OF_MEAN|3.885|||TWO_SIDED|95.0|-15.71|5.86|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Afternoon assessment.|||5.86|-15.71|
70939234|NCT03345407|141379314|OTHER||Posterior median odds ratio|0.75|||||TWO_SIDED|95.0|0.38|1.25|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.25|0.38|
70939235|NCT03345407|141379314|OTHER||Posterior median odds ratio|1.16|||||TWO_SIDED|95.0|0.77|1.63|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.63|0.77|
71070949|NCT00742508|141650781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.74|STANDARD_ERROR_OF_MEAN|6.07|||TWO_SIDED|95.0|-7.11|26.59|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Night assessment.|||26.59|-7.11|
71070950|NCT00742508|141650781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.45|STANDARD_ERROR_OF_MEAN|4.08|||TWO_SIDED|95.0|-14.78|7.88|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Waking assessment.|||7.88|-14.78|
71070951|NCT00742508|141650781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.06|STANDARD_ERROR_OF_MEAN|1.694|||TWO_SIDED|95.0|13.36|22.76|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Sleeping assessment.|||22.76|13.36|
71070952|NCT00742508|141650781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.46|STANDARD_ERROR_OF_MEAN|8.902|||TWO_SIDED|95.0|-32.17|17.26|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmax assessment.|||17.26|-32.17|
71070953|NCT00742508|141650781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|5.297|||TWO_SIDED|95.0|-13.61|15.8|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmin assessment.|||15.80|-13.61|
71070954|NCT00742508|141650781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.152|||TWO_SIDED|95.0|-0.54|0.3|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmax/PDmin assessment.|||0.30|-0.54|
71070955|NCT00742508|141650782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.99|STANDARD_ERROR_OF_MEAN|3.187|||TWO_SIDED|95.0|-12.84|4.86|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the 24 h assessment.|||4.86|-12.84|
71070956|NCT00742508|141650782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.27|STANDARD_ERROR_OF_MEAN|2.962|||TWO_SIDED|95.0|-13.5|2.95|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Morning assessment.|||2.95|-13.50|
71113911|NCT05360966|141735161|OTHER|Difference (2-sided)|Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|2.08||0.1321|TWO_SIDED|95.0|-7.2|0.9||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center.|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||0.9|-7.2|0.1321
71070957|NCT00742508|141650782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.98|STANDARD_ERROR_OF_MEAN|3.209|||TWO_SIDED|95.0|-10.89|6.94|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Afternoon assessment.|||6.94|-10.89|
71070958|NCT00742508|141650782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.14|STANDARD_ERROR_OF_MEAN|3.665|||TWO_SIDED|95.0|-14.32|6.03|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Night assessment.|||6.03|-14.32|
71070959|NCT00742508|141650782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.99|STANDARD_ERROR_OF_MEAN|3.047|||TWO_SIDED|95.0|-11.45|5.47|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Waking assessment.|||5.47|-11.45|
71070960|NCT00742508|141650782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.11|STANDARD_ERROR_OF_MEAN|4.686|||TWO_SIDED|95.0|-16.12|9.89|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Sleeping assessment.|||9.89|-16.12|
71070961|NCT00742508|141650782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.0|STANDARD_ERROR_OF_MEAN|3.749|||TWO_SIDED|95.0|-20.41|0.41|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmax assessment.|||0.41|-20.41|
71070962|NCT00742508|141650782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.42|STANDARD_ERROR_OF_MEAN|5.249|||TWO_SIDED|95.0|-16.0|13.15|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmin assessment.|||13.15|-16.00|
71070963|NCT00742508|141650782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|95.0|-0.71|0.03|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmax/PDmin assessment.|||0.03|-0.71|
71070964|NCT04017832|141650786|SUPERIORITY||Mean Difference (Net)|-0.2||||0.0078|TWO_SIDED|95.0|-0.3|-0.1||Unadjusted two-sided p-value|Mixed model for repeated measurements|||||-0.1|-0.3|0.0078
71070965|NCT04017832|141650786|SUPERIORITY||Mean Difference (Net)|-0.7|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.6||Unadjusted two-sided p-value|Mixed model for repeated measurements|||||-0.6|-0.8|<0.0001
71070966|NCT04017832|141650786|SUPERIORITY||Mean Difference (Net)|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.8||Unadjusted two-sided p-value|Mixed model for repeated measurements|||||-0.8|-1.1|< 0.0001
71070967|NCT04257032|141650832|OTHER||Ratio of geometric means (T/R) %|105.37|||||TWO_SIDED|90.0|97.94|113.35|||ANOVA|ANOVA model on the logarithmic scale, considering the effects 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random.|Intra-individual coefficient of variation (gCV %) = 9.9|Relative bioavailability||113.35|97.94|
71070968|NCT04257032|141650833|OTHER||Ratio of geometric means (T/R) %|114.5|||||TWO_SIDED|90.0|104.22|125.81|||ANOVA|ANOVA model on the logarithmic scale, considering the effects 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random.|Intra-individual coefficient of variation (gCV %) = 14.0|Relative bioavailability||125.81|104.22|
71070969|NCT04257032|141650834|OTHER||Ratio of geometric means (T/R) %|108.18|||||TWO_SIDED|90.0|100.26|116.73|||ANOVA|ANOVA model on the logarithmic scale, considering the effects 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random.|Intra-individual coefficient of variation (gCV %) = 11.3|Relative bioavailability||116.73|100.26|
71070970|NCT04257032|141650835|OTHER||Ratio of geometric means (T/R) %|108.89|||||TWO_SIDED|90.0|99.84|118.76|||ANOVA|ANOVA model on the logarithmic scale, considering the effects 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random.|Intra-individual coefficient of variation (gCV %) = 12.9|Relative bioavailability||118.76|99.84|
70852883|NCT03745820|141194613|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|1.323|=|0.8053|TWO_SIDED|95.0|-2.94|2.29|||MMRM|||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.||2.29|-2.94|=0.8053
70852884|NCT03745820|141194617|SUPERIORITY||LS Mean Difference|3.43|STANDARD_ERROR_OF_MEAN|1.835|=|0.0637|TWO_SIDED|95.0|-0.2|7.06|||ANCOVA|||An analysis of covariance (ANCOVA) model was applied adjusting for treatment group and baseline value of the OM.||7.06|-0.20|=0.0637
70939236|NCT03345407|141379314|OTHER||Posterior median odds ratio|1.21|||||TWO_SIDED|95.0|0.36|2.69|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.69|0.36|
71070971|NCT04257032|141650836|OTHER||Ratio of geometric means (T/R) %|104.52|||||TWO_SIDED|90.0|97.34|112.23|||ANOVA|ANOVA model on the logarithmic scale, considering the effects 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random.|Intra-individual coefficient of variation (gCV %) = 10.6|Relative bioavailability||112.23|97.34|
71070972|NCT04257032|141650837|OTHER||Ratio of geometric means (T/R) %|108.42|||||TWO_SIDED|90.0|100.37|117.12|||ANOVA|ANOVA model on the logarithmic scale, considering the effects 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random.|Intra-individual coefficient of variation (gCV %) = 11.5|Relative bioavailability||117.12|100.37|
71070973|NCT02091986|141650846|SUPERIORITY_OR_OTHER|||||||0.006|||||||Mixed Models Analysis|Baseline FEV1, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.006
71070974|NCT02091986|141650846|SUPERIORITY_OR_OTHER|||||||0.063|||||||Mixed Models Analysis|Baseline FEV1, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.063
71070975|NCT02091986|141650846|SUPERIORITY_OR_OTHER|||||||0.373|||||||Mixed Models Analysis|Baseline FEV1, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.373
70852885|NCT03745820|141194617|SUPERIORITY||LS Mean Difference|3.42|STANDARD_ERROR_OF_MEAN|1.844|=|0.0659|TWO_SIDED|95.0|-0.23|7.06|||ANCOVA|||An ANCOVA model was applied adjusting for treatment group and baseline value of the OM.||7.06|-0.23|=0.0659
71070976|NCT02091986|141650847|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.001
71070977|NCT02091986|141650847|SUPERIORITY_OR_OTHER|||||||0.195|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.195
71070978|NCT02091986|141650847|SUPERIORITY_OR_OTHER|||||||0.032|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.032
71070979|NCT02091986|141650848|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||<0.001
71070980|NCT02091986|141650848|SUPERIORITY_OR_OTHER|||||||0.005|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.005
71070981|NCT02091986|141650848|SUPERIORITY_OR_OTHER|||||||0.326|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.326
71070982|NCT02091986|141650849|SUPERIORITY_OR_OTHER|||||||0.276|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.276
71070983|NCT02091986|141650849|SUPERIORITY_OR_OTHER|||||||0.759|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.759
71070984|NCT02091986|141650849|SUPERIORITY_OR_OTHER|||||||0.165|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.165
71070985|NCT02091986|141650850|SUPERIORITY_OR_OTHER|||||||0.724|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.724
71070986|NCT02091986|141650850|SUPERIORITY_OR_OTHER|||||||0.909|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.909
71070987|NCT02091986|141650850|SUPERIORITY_OR_OTHER|||||||0.811|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.811
71070988|NCT02091986|141650851|SUPERIORITY_OR_OTHER|||||||0.134|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.134
71070989|NCT02091986|141650851|SUPERIORITY_OR_OTHER|||||||0.985|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.985
71070990|NCT02091986|141650851|SUPERIORITY_OR_OTHER|||||||0.128|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.128
71070991|NCT02091986|141650852|SUPERIORITY_OR_OTHER|||||||0.684|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.684
71070992|NCT02091986|141650852|SUPERIORITY_OR_OTHER|||||||0.621|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.621
71070993|NCT02091986|141650852|SUPERIORITY_OR_OTHER|||||||0.929|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.929
71070994|NCT02091986|141650853|SUPERIORITY_OR_OTHER|||||||0.664|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.664
71070995|NCT02091986|141650853|SUPERIORITY_OR_OTHER|||||||0.747|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.747
71070996|NCT02091986|141650853|SUPERIORITY_OR_OTHER|||||||0.913|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.913
71070997|NCT02091986|141650854|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANCOVA|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.015
71070998|NCT02091986|141650854|SUPERIORITY_OR_OTHER|||||||0.342|||||||ANCOVA|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.342
71070999|NCT02091986|141650854|SUPERIORITY_OR_OTHER|||||||0.138|||||||ANCOVA|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.138
71071000|NCT02091986|141650858|SUPERIORITY_OR_OTHER|||||||0.098|||||||ANCOVA|The explanatory variables included in the model are: treatment group, baseline overall PAQLQ(S) score, region and age group||||||0.098
71071001|NCT02091986|141650858|SUPERIORITY_OR_OTHER|||||||0.367|||||||ANCOVA|The explanatory variables included in the model are: treatment group, baseline overall PAQLQ(S) score, region and age group||||||0.367
71071002|NCT02091986|141650858|SUPERIORITY_OR_OTHER|||||||0.449|||||||ANCOVA|The explanatory variables included in the model are: treatment group, baseline overall PAQLQ(S) score, region and age group||||||0.449
71071003|NCT00794040|141650876|SUPERIORITY||Odds Ratio (OR)|11.7||||0.006|TWO_SIDED|95.0|2.0|68.16||priori threshold p\<0.05|Multilevel growth curve model|||||68.16|2.00|0.006
71071004|NCT00794040|141650877|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.085|TWO_SIDED|95.0|-1.32|0.09||priori threshold \<0.05|Multilevel growth curve model|||||0.09|-1.32|0.085
71071005|NCT00794040|141650878|SUPERIORITY||Mean Difference (Final Values)|4.72||||0.124|TWO_SIDED|95.0|-1.3|10.74||priori threshold p\<0.05|Wilcoxon (Mann-Whitney)|||||10.74|-1.30|0.124
71071006|NCT00794040|141650879|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.993|TWO_SIDED|95.0|-4.76|4.8||priori threshold p\<0.05|Multilevel growth curve model|||||4.80|-4.76|0.993
71071007|NCT00794040|141650880|SUPERIORITY||Mean Difference (Final Values)|1.02||||0.598|TWO_SIDED|95.0|-4.23|2.19||priori threshold p\<0.05|Multilevel growth curve model|||||2.19|-4.23|0.598
71071008|NCT02396420|141650881|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
71071009|NCT02396420|141650882|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
71071010|NCT02396420|141650883|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
71071011|NCT02396420|141650884|OTHER|Statistical analysis was not performed as this data was not available for any subjects in the analysis population.||||||||||||||||Statistical analysis was not performed as this data was not available for any subjects in the analysis population.|Statistical analysis was not performed as this data was not available for any subjects in the analysis population.|||
71071012|NCT02396420|141650885|OTHER|Statistical analysis was not performed as this data was not available for any subjects in the analysis population.||||||||||||||||Statistical analysis was not performed as this data was not available for any subjects in the analysis population.|Statistical analysis was not performed as this data was not available for any subjects in the analysis population.|||
71071013|NCT02396420|141650886|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
71071014|NCT02396420|141650887|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
71071015|NCT02396420|141650888|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
71071016|NCT02396420|141650889|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
71071017|NCT02396420|141650890|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
71071018|NCT02396420|141650891|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
71071019|NCT02396420|141650892|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
71071020|NCT02396420|141650893|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
71071021|NCT02396420|141650894|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
71071022|NCT02396420|141650895|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
71071023|NCT02396420|141650896|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
71071024|NCT02396420|141650897|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
71071025|NCT01273623|141650898|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71079400|NCT00482170|141666421|SUPERIORITY_OR_OTHER||Regression coefficient|-0.38||||0.195|TWO_SIDED|95.0|-0.89|0.14||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, high school or baccalaureate level and reading or writing capacity (reference).||0.14|-0.89|0.195
70939237|NCT03345407|141379314|OTHER||Posterior median odds ratio|1.53|||||TWO_SIDED|95.0|0.82|2.33|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.33|0.82|
71071026|NCT04064411|141650901|NON_INFERIORITY|"Noninferiority margin = 2.0% for abaloparatide-sMTS compared with abaloparatide-SC.~Non-inferiority was to be concluded if the lower bound of the 2-sided 95% confidence interval (CI) for the estimated treatment difference (abaloparatide-sMTS minus abaloparatide-SC) in the percent change from baseline in lumbar spine BMD at 12 months was above -2.0% using a Mixed Model for Repeated Measures (MMRM) analysis."|Least Squares Means (LSM) Difference|-3.721|||||TWO_SIDED|95.0|-5.0089|-2.4331|||||LSM Difference = abaloparatide-sMTS minus abaloparatide-SC|||-2.4331|-5.0089|
71071027|NCT01970475|141650912|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis was tested by comparing the 2-sided 90% confidence interval (CI) of the RR of ACR20 at week 24 between ABP 501 and adalimumab with an equivalence margin of (0.738, 1/0.738).|Risk Ratio (RR)|1.039|||||TWO_SIDED|90.0|0.954|1.133|||||Based on a generalized linear model adjusted for geographic region and prior biological use for RA as covariates in the model.|The study hypothesis was that there were no clinically meaningful differences between ABP 501 and adalimumab in risk ratio (RR) of ACR20 at week 24.||1.133|0.954|
71071028|NCT00908791|141650919|SUPERIORITY_OR_OTHER|||||||0.003|||||||McNemar|exact McNemar test for paired binary data.||||||0.003
71071029|NCT00908791|141650920|SUPERIORITY_OR_OTHER|||||||0.41|||||||McNemar|||||||0.41
71071030|NCT00908791|141650921|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|95.0|||||bowker's test of symmetry|||||||0.48
71071031|NCT00908791|141650922|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED|95.0|||||Sign test|||The Sign-Rank test for paired data.||||0.029
71071032|NCT00908791|141650923|SUPERIORITY_OR_OTHER|||||||0.62|||||||t-test, 2 sided|||||||0.62
71117699|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-6.29||||0.162|TWO_SIDED|95.0|-14.97|2.4||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.40|-14.97|0.162
70939238|NCT03345407|141379314|OTHER||Posterior median odds ratio|1.16|||||TWO_SIDED|95.0|0.67|1.79|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.79|0.67|
71071033|NCT00908791|141650924|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|95.0|||||Other|||||||>0.05
71071034|NCT00908791|141650925|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|95.0|||||Other|||||||>0.05
71071035|NCT03192995|141650927|SUPERIORITY|||||||0.91|||||||Fisher Exact|||||||0.91
71071036|NCT03192995|141650928|SUPERIORITY|||||||0.53|||||||Fisher Exact|||||||0.53
71071037|NCT03192995|141650929|SUPERIORITY|||||||0.32|||||||Fisher Exact|||||||.32
71071038|NCT03192995|141650930|SUPERIORITY|||||||0.541|||||||Fisher Exact|||||||.541
71071039|NCT03192995|141650931|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.24|3.82||||||||3.82|0.24|
71071040|NCT02579343|141650934|SUPERIORITY|||||||0.05||||||P-value above was calculated. Does not reference threshold for clinical significance.|Repeated Measures Analysis of Variance|||||||.05
71071041|NCT02579343|141650935|SUPERIORITY|||||||0.05|||||||Repeated Measures Analysis of Variance|||||||.05
71071042|NCT05027048|141650953|SUPERIORITY||Mean Difference (Net)|211.0|||<|0.05|TWO_SIDED|95.0|-33.0|410.0||a priori threshold for statistical significance p\<0.05|inverse Gaussian distribution and log li|Inverse Gaussian distribution and log link fit to estimate the effect size and 95% CIs|Inverse gaussian regression with a log link was used to calculate the mean reduction in blood loss in the calcium group relative to placebo group.|||410|-33|<0.05
71071043|NCT05027048|141650954|SUPERIORITY||Risk Ratio (RR)|0.71|||||TWO_SIDED|95.0|0.48|1.03|||Regression (poisson with robust SE)|||||1.03|0.48|
71071044|NCT05027048|141650955|SUPERIORITY||Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.46|1.23|||Poisson regression with robust SE|||||1.23|0.46|
71071045|NCT05027048|141650956|SUPERIORITY||Risk Ratio (RR)|0.56|||||TWO_SIDED|95.0|0.2|1.56||||||||1.56|0.2|
71071046|NCT05027048|141650957|SUPERIORITY||Mean Difference (Final Values)|-2.0|||||TWO_SIDED|95.0|-3.6|0.2|||Regression, Linear|Data were log transformed to approximate a normal distribution prior to linear regression.||||0.2|-3.6|
71071047|NCT05027048|141650959|SUPERIORITY|||||||0.415|||||||Wilcoxon (Mann-Whitney)|||||||0.415
71071048|NCT05027048|141650960|SUPERIORITY|||||||0.566|||||||Wilcoxon (Mann-Whitney)|||||||0.566
71071049|NCT05027048|141650962|SUPERIORITY|||||||0.348|||||||ANOVA|||Repeated measures ANOVA used to analyze differences between groups.||||0.348
71071050|NCT05027048|141650963|SUPERIORITY|||||||0.011|||||||ANOVA|Repeated measures ANOVA.||Repeated measures ANOVA used to assess for difference between groups in the % change from baseline heart rate.||||0.011
71071051|NCT05027048|141650965|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||0.25
71071052|NCT05027048|141650966|OTHER||||||||||||||||||"Note: a two-compartment pharmacokinetic model was generated in NONMEM using 6 venous blood ionized calcium measurements per participant at random times. The change in ionized calcium was defined as a measured value minus the measured baseline for the patient.~Once the two-compartment pharmacokinetic model was generated, NONMEM was used to generate a predicted ionized calcium concentration at 10 minutes (Tmax) for each participant to generate mean and 95% confidence interval."|||
71071053|NCT05027048|141650968|SUPERIORITY||Mean Difference (Net)|356.0|||<|0.05|TWO_SIDED|95.0|159.0|515.0|||Inverse Gaussian regression, log link||Reduction in blood loss was calculated by inverse Gaussian regression with a log link as detailed in the description of statistical methods for the primary outcome.|||515|159|<0.05
71071054|NCT01871402|141650992|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||"Treatment groups were compared with respect to the proportions of subjects with treatment success at Day 15 using the Cochran-Mantel-Haenszel (CMH) test stratified by analysis center."|Cochran-Mantel-Haenszel|Multiple imputation was used to impute missing data from the ITT population.||||||<0.001
71071055|NCT01871402|141650993|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance (\<0.001) was achieved for each of the clinical signs of psoriasis (scaling, erythema, and plaque elevation).|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema, and plaque elevation).||||<0.001
71071056|NCT01871402|141650994|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71071057|NCT01871402|141650995|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance (\<0.001) was achieved for each of the clinical signs of psoriasis (scaling, erythema, and plaque elevations).|Cochran-Mantel-Haenszel|||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema, and plaque elevation).||||<0.001
71071058|NCT05356533|141650998|SUPERIORITY||Risk Ratio (RR)|1.08|||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>.05
71071059|NCT05356533|141650998|SUPERIORITY||Risk Ratio (RR)|1.08|||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
71071060|NCT05356533|141650999|SUPERIORITY||Risk Ratio (RR)|1.08|||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>.05
71071061|NCT05356533|141651000|SUPERIORITY||Risk Ratio (RR)|0.81|||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>.05
71071062|NCT05356533|141651001|SUPERIORITY||Risk Ratio (RR)|0.91|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<.05
71071063|NCT05356533|141651002|SUPERIORITY||Risk Ratio (RR)|0.99|||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>.05
71071064|NCT05356533|141651003|SUPERIORITY||Risk Ratio (RR)|1.11|||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>.05
71113912|NCT05360966|141735162|OTHER|Difference (2-sided)|Least Squares Mean Difference|8.3|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED|95.0|6.9|9.8||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||9.8|6.9|<0.0001
70852886|NCT03745820|141194618|SUPERIORITY||LS Mean Difference|0.208|STANDARD_ERROR_OF_MEAN|0.09|=|0.6653|TWO_SIDED|95.0|-0.32|0.5|||ANCOVA|||An ANCOVA model was applied adjusting for treatment group and baseline value of the OM.||0.50|-0.32|=0.6653
71071065|NCT05896527|141651004|SUPERIORITY||Odds Ratio (OR)|0.46||||0.4839|TWO_SIDED|95.0|0.07|2.37|||Fisher Exact||DC-806 200 mg BID compared to Placebo|||2.37|0.07|0.4839
71071066|NCT05896527|141651004|SUPERIORITY||Odds Ratio (OR)|1.76||||0.4111|TWO_SIDED|95.0|0.51|6.49|||Fisher Exact||DC-806 400 mg BID compared to Placebo|||6.49|0.51|0.4111
71071067|NCT05896527|141651004|SUPERIORITY||Odds Ratio (OR)|1.3||||0.7744|TWO_SIDED|95.0|0.36|4.99|||Fisher Exact||DC-806 600 mg QD compared to Placebo|||4.99|0.36|0.7744
71071068|NCT05896527|141651004|SUPERIORITY||Odds Ratio (OR)|3.59||||0.0164|TWO_SIDED|95.0|1.15|12.37|||Fisher Exact||DC-806 800 mg BID compared to Placebo|||12.37|1.15|0.0164
71071069|NCT01279070|141651006|SUPERIORITY_OR_OTHER||Effect size|0.43|||<|0.05|TWO_SIDED|95.0|0.1|0.7|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups,standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR)assumption.|To evaluate intervention efficacy on the BADS(Total score and Key search subtest),linear mixed-effects models were fitted using Restricted Maximum Likelihood (REML.An unstructured correlation matrix was used to account for correlation among several observations for each subject.The dependent variable comprised the measures at 16 weeks while the baseline value of the BADS,intervention group(REPYFLEC group vs Leisure group),time and the interaction term (time×treatment)were included as covariates.||0.7|0.1|<0.05
71071070|NCT01279070|141651007|SUPERIORITY_OR_OTHER||Effect Size|0.42|||<|0.05|TWO_SIDED|95.0|0.1|0.7|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups,standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR)assumption.|To evaluate intervention efficacy on the BADS(Total score and Key search subtest),linear mixed-effects models were fitted using Restricted Maximum Likelihood(REML).An unstructured correlation matrix was used to account for correlation among several observations for each subject.The dependent variable comprised the measures at 40 weeks while the baseline value of the BADS,intervention group(REPYFLEC group vs Leisure group),time and the interaction term (time×treatment)were included as covariates.||0.7|0.1|<0.05
71071071|NCT01279070|141651008|SUPERIORITY_OR_OTHER||Effect Size|0.33|||<|0.05|TWO_SIDED|95.0|0.06|0.6|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups,standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR)assumption.|To evaluate intervention efficacy on the LSP, linear mixed-effects models were fitted using Restricted Maximum Likelihood (REML). An unstructured correlation matrix was used to account for correlation among several observations for each subject. The dependent variable comprised the measures at 16 weeks while the baseline value of the LSP, intervention group (REPYFLEC group vs Leisure group), time and the interaction term (time×treatment) were included as covariates.||0.6|0.06|<0.05
71071072|NCT01279070|141651009|SUPERIORITY_OR_OTHER||Effect Size|0.35|||<|0.05|TWO_SIDED|95.0|0.09|0.6|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups,standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR)assumption.|To evaluate intervention efficacy on the LSP, linear mixed-effects models were fitted using Restricted Maximum Likelihood (REML). An unstructured correlation matrix was used to account for correlation among several observations for each subject. The dependent variable comprised the measures at 40 weeks while the baseline value of the LSP, intervention group (REPYFLEC group vs Leisure group), time and the interaction term (time×treatment) were included as covariates.||0.6|0.09|<0.05
71071073|NCT01279070|141651010|SUPERIORITY_OR_OTHER||Effect Size|0.3|||<|0.05|TWO_SIDED|95.0|0.01|0.7|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups,standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR)assumption.|To evaluate intervention efficacy on the PANSS, linear mixed-effects models were fitted using Restricted Maximum Likelihood (REML). An unstructured correlation matrix was used to account for correlation among several observations for each subject. The dependent variable comprised the measures at 16 weeks while the baseline value of the PANSS, intervention group (REPYFLEC group vs Leisure group), time and the interaction term (time×treatment) were included as covariates.||0.7|0.01|<0.05
70939239|NCT03345407|141379314|OTHER||Posterior median odds ratio|1.12|||||TWO_SIDED|95.0|0.63|1.74|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.74|0.63|
70939240|NCT03345407|141379314|OTHER||Posterior median odds ratio|0.55|||||TWO_SIDED|95.0|0.28|0.88|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||0.88|0.28|
70939241|NCT03345407|141379314|OTHER||Posterior median odds ratio|1.08|||||TWO_SIDED|95.0|0.72|1.49|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.49|0.72|
70939242|NCT03345407|141379314|OTHER||Posterior median odds ratio|1.0|||||TWO_SIDED|95.0|0.3|2.17|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.17|0.30|
70939243|NCT03345407|141379314|OTHER||Posterior median odds ratio|1.46|||||TWO_SIDED|95.0|0.84|2.27|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.27|0.84|
70939244|NCT03345407|141379314|OTHER||Posterior median odds ratio|1.15|||||TWO_SIDED|95.0|0.65|1.78|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.78|0.65|
70939245|NCT03345407|141379314|OTHER||Posterior median odds ratio|1.09|||||TWO_SIDED|95.0|0.62|1.67|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.67|0.62|
71113913|NCT05360966|141735163|OTHER|Difference (2-sided)|Difference in Percentages|40.1|||<|0.0001|TWO_SIDED|95.0|32.3|47.9||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|Pearson's Chi-squared test||Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|For binary endpoint, the underlying continuous measurement of unanesthetized Schirmer score was imputed, change score calculated and then dichotomized to ascertain attainment of greater than or equal to 10 millimeter increase from pre-drop baseline.|47.9|32.3|<0.0001
71113914|NCT05360966|141735164|OTHER|Difference (2-sided)|Least Squares Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|6.3|8.9||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||8.9|6.3|<0.0001
70939246|NCT03345407|141379314|OTHER||Posterior median odds ratio|0.49|||||TWO_SIDED|95.0|0.26|0.77|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||0.77|0.26|
70939247|NCT03345407|141379314|OTHER||Posterior median odds ratio|1.04|||||TWO_SIDED|95.0|0.71|1.42|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.42|0.71|
70939248|NCT03345407|141379314|OTHER||Posterior median odds ratio|1.08|||||TWO_SIDED|95.0|0.32|2.38|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.38|0.32|
70939249|NCT03345407|141379314|OTHER||Posterior median odds ratio|1.29|||||TWO_SIDED|95.0|0.7|2.0|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.00|0.70|
70939250|NCT03345407|141379314|OTHER||Posterior median odds ratio|1.12|||||TWO_SIDED|95.0|0.63|1.71|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.71|0.63|
70939251|NCT03345407|141379314|OTHER||Posterior median odds ratio|0.95|||||TWO_SIDED|95.0|0.55|1.48|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.48|0.55|
70939252|NCT03345407|141379314|OTHER||Posterior median odds ratio|0.56|||||TWO_SIDED|95.0|0.31|0.87|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||0.87|0.31|
70939253|NCT03345407|141379314|OTHER||Posterior median odds ratio|1.08|||||TWO_SIDED|95.0|0.73|1.47|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.47|0.73|
70939254|NCT03345407|141379315|OTHER||Posterior median hazard ratio|1.053|||||TWO_SIDED|95.0|0.477|1.765|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.|||1.765|0.477|
70939255|NCT03345407|141379315|OTHER||Posterior median hazard ratio|1.2|||||TWO_SIDED|95.0|0.84|1.597|||||Treatment comparison between placebo and Nemiralisib 50 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.|||1.597|0.840|
70939256|NCT03345407|141379315|OTHER||Posterior median hazard ratio|1.06|||||TWO_SIDED|95.0|0.734|1.432|||||Treatment comparison between placebo and Nemiralisib 100 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.|||1.432|0.734|
70939257|NCT03345407|141379315|OTHER||Posterior median hazard ratio|1.03|||||TWO_SIDED|95.0|0.719|1.413|||||Treatment comparison between placebo and Nemiralisib 250 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.|||1.413|0.719|
70939258|NCT03345407|141379315|OTHER||Posterior median hazard ratio|0.751|||||TWO_SIDED|95.0|0.487|1.057|||||Treatment comparison between placebo and Nemiralisib 500 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.|||1.057|0.487|
71071074|NCT01279070|141651011|SUPERIORITY_OR_OTHER||Effect Size|0.3|||<|0.05|TWO_SIDED|95.0|0.01|0.7|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups, standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR) assumption.|To evaluate intervention efficacy on the PANSS, linear mixed-effects models were fitted using Restricted Maximum Likelihood (REML). An unstructured correlation matrix was used to account for correlation among several observations for each subject. The dependent variable comprised the measures at 40 weeks while the baseline value of the PANSS, intervention group (REPYFLEC group vs Leisure group), time and the interaction term (time×treatment) were included as covariates.||0.7|0.01|<0.05
71071075|NCT05139303|141651017|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
71079401|NCT00482170|141666421|SUPERIORITY_OR_OTHER||Regression coefficient|-0.55||||0.195|TWO_SIDED|95.0|-1.21|0.11||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, university level and reading or writing capacity (reference).||0.11|-1.21|0.195
71079402|NCT00482170|141666422|SUPERIORITY_OR_OTHER||Regression coefficient|-0.09||||0.493|TWO_SIDED|95.0|-0.36|0.17||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, HAD-A: =\< 4, HAD-A: \> 4 to 7, HAD-A: \> 7 to 10 and HAD-A: \> 10; by 5 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.17|-0.36|0.493
71079403|NCT00482170|141666422|SUPERIORITY_OR_OTHER||Regression coefficient|-0.16||||0.287|TWO_SIDED|95.0|-0.46|0.14||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, HAD-D: =\< 3, HAD-D: \> 3 to 5, HAD-D: \> 5 to 8 and HAD-A: \> 8; by 5 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.14|-0.46|0.287
71079404|NCT00482170|141666423|SUPERIORITY_OR_OTHER||Regression coefficient|0.13||||0.123|TWO_SIDED|95.0|-0.04|0.3||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 10 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.30|-0.04|0.123
71079405|NCT00482170|141666424|SUPERIORITY_OR_OTHER||Regression coefficient|-0.24||||0.359|TWO_SIDED|95.0|-0.76|0.28||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, yes and no (reference).||0.28|-0.76|0.359
71079406|NCT00482170|141666425|SUPERIORITY_OR_OTHER||Regression coefficient|0.02||||0.693|TWO_SIDED|95.0|-0.08|0.12|||Regression, Linear|||Statistical analysis was carried out between all categories, by 5 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.12|-0.08|0.693
71079407|NCT00482170|141666426|SUPERIORITY_OR_OTHER||Regression coefficient|0.22||||0.17|TWO_SIDED|95.0|-0.09|0.53||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 1 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.53|-0.09|0.170
71079408|NCT00482170|141666427|SUPERIORITY_OR_OTHER||Regression coefficient|0.02||||0.211|TWO_SIDED|95.0|-0.01|0.04||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 1 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.04|-0.01|0.211
71079409|NCT00482170|141666428|SUPERIORITY_OR_OTHER||Regression coefficient|0.09||||0.045|TWO_SIDED|95.0|0.0|0.18||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 10 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.18|0.00|0.045
71079410|NCT00482170|141666429|SUPERIORITY_OR_OTHER||Regression coefficient|-0.01||||0.913|TWO_SIDED|95.0|-0.12|0.11||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 10 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.11|-0.12|0.913
71079411|NCT00482170|141666430|SUPERIORITY_OR_OTHER||Regression coefficient|0.0||||0.968|TWO_SIDED|95.0|-0.17|0.17||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 5 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.17|-0.17|0.968
71079412|NCT00482170|141666431|SUPERIORITY_OR_OTHER||Regression coefficient|-0.15||||0.531|TWO_SIDED|95.0|-0.61|0.32||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, current tobacco usage: yes and current tobacco usage: no (reference).||0.32|-0.61|0.531
71079413|NCT00482170|141666431|SUPERIORITY_OR_OTHER||Regression coefficient|0.44||||0.061|TWO_SIDED|95.0|-0.02|0.9||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, current alcohol usage: yes and current alcohol usage: no (reference).||0.90|-0.02|0.061
71079414|NCT00482170|141666432|SUPERIORITY_OR_OTHER||Regression coefficient|-0.73||||0.759|TWO_SIDED|95.0|-5.37|3.92||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, yes and no (reference).||3.92|-5.37|0.759
71079415|NCT00482170|141666433|SUPERIORITY_OR_OTHER||Regression coefficient|0.09||||0.713|TWO_SIDED|95.0|-0.37|0.55||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, yes and no (reference).||0.55|-0.37|0.713
71079416|NCT00482170|141666434|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39|||<|0.001|TWO_SIDED|95.0|1.63|3.49||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.49|1.63|<0.001
71113915|NCT05360966|141735165|OTHER|Difference (2 sided)|Difference in Percentages|37.3|||<|0.0001|TWO_SIDED|95.0|28.7|45.9||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|Pearson's Chi-squared test||Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|For binary endpoint, the underlying continuous measurement of unanesthetized Schirmer score was imputed, change score calculated and then dichotomized to ascertain attainment of greater than or equal to 10 millimeter increase from pre-drop baseline.|45.9|28.7|<0.0001
71113916|NCT05360966|141735166|OTHER|Difference (2-sided)|Least Squares Mean Difference|8.1|STANDARD_ERROR_OF_MEAN|0.78|<|0.0001|TWO_SIDED|95.0|6.5|9.6||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||9.6|6.5|<0.0001
71113917|NCT05360966|141735167|OTHER|Difference (2-sided)|Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|2.4||0.5626|TWO_SIDED|95.0|-6.1|3.3||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||3.3|-6.1|0.5626
71113918|NCT05360966|141735168|OTHER|Difference (2-sided)|Least Squares Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|2.53||0.5981|TWO_SIDED|95.0|-6.3|3.6||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||3.6|-6.3|0.5981
71113919|NCT05360966|141735169|OTHER|Difference (2-sided)|Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|2.44||0.5161|TWO_SIDED|95.0|-6.4|3.2||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||3.2|-6.4|0.5161
71113920|NCT05360966|141735170|OTHER|Difference (2-sided)|Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|2.51||0.8574|TWO_SIDED|95.0|-4.5|5.4||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||5.4|-4.5|0.8574
71117700|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-76.81|||<|0.001|TWO_SIDED|95.0|-91.35|-62.27||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-62.27|-91.35|<0.001
70852887|NCT03745820|141194618|SUPERIORITY||LS Mean Difference|0.206|STANDARD_ERROR_OF_MEAN|0.1|=|0.614|TWO_SIDED|95.0|-0.3|0.51|||ANCOVA|||An ANCOVA model was applied adjusting for treatment group and baseline value of the OM.||0.51|-0.30|=0.6140
70939259|NCT03345407|141379315|OTHER||Posterior median hazard ratio|1.149|||||TWO_SIDED|95.0|0.899|1.426|||||Treatment comparison between placebo and Nemiralisib 750 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.|||1.426|0.899|
70852888|NCT03745820|141194619|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|1.033|=|0.2886|TWO_SIDED|95.0|-3.14|0.94|||MMRM|||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.||0.94|-3.14|=0.2886
71113921|NCT05360966|141735171|OTHER|Difference (2-sided)|Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|2.69||0.698|TWO_SIDED|95.0|-6.3|4.2||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||4.2|-6.3|0.6980
71113922|NCT03522246|141735172|SUPERIORITY|Rucaparib vs Placebo|Hazard Ratio (HR)|0.47||||0.0004|TWO_SIDED|95.0|0.31|0.72|||Log Rank||The stratified cox proportional hazard model is adjusted for the randomization strata of HRD classification and timing of surgery.|||0.72|0.31|0.0004
71113923|NCT03522246|141735173|SUPERIORITY|Rucaparib vs Placebo|Hazard Ratio (HR)|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.68|||Log Rank||The stratified cox proportional hazard model is adjusted for the randomization strata of HRD classification, disease status post-chemotherapy, and timing of surgery.|||0.68|0.40|<0.0001
71113924|NCT03522246|141735174|SUPERIORITY|Rucaparib + Nivolumab vs Rucaparib + Placebo|Hazard Ratio (HR)|1.29||||0.0038|TWO_SIDED|95.0|1.08|1.53|||Log Rank||The stratified cox proportional hazard model is adjusted for the randomization strata of HRD classification, disease status post-chemotherapy, and timing of surgery.|||1.53|1.08|0.0038
71113925|NCT04683029|141735187|SUPERIORITY||LS Mean Difference|-12.6|||<|0.001|TWO_SIDED|80.0|-13.8|-11.4|||MMRM model|||||-11.4|-13.8|< 0.001
71113926|NCT04683029|141735188|SUPERIORITY||LS Mean Difference|-12.0|||||TWO_SIDED|80.0|-13.3|-10.7||||||||-10.7|-13.3|
71113927|NCT04683029|141735189|SUPERIORITY||Odds Ratio (OR)|0.1|||||TWO_SIDED|80.0|0.0|0.3||||||Week 24||0.3|0.0|
71113928|NCT04683029|141735189|SUPERIORITY||Odds Ratio (OR)|0.1|||||TWO_SIDED|80.0|0.0|0.2||||||Week 52||0.2|0.0|
71113929|NCT04683029|141735190|SUPERIORITY||Odds Ratio (OR)|203.2|||||TWO_SIDED|80.0|42.1|980.6||||||Week 24||980.6|42.1|
70939260|NCT03345407|141379317|OTHER||Posterior median odds ratio|1.22|||||TWO_SIDED|95.0|0.35|2.7|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.70|0.35|
71113930|NCT04683029|141735190|SUPERIORITY||Odds Ratio (OR)|130.3|||||TWO_SIDED|80.0|28.2|601.9||||||Week 52||601.9|28.2|
71113931|NCT04683029|141735191|SUPERIORITY||LS Mean Difference|-47.2|||||TWO_SIDED|80.0|-96.8|2.4||||||Week 24||2.4|-96.8|
71113932|NCT04683029|141735191|SUPERIORITY||LS Mean difference|-14.2|||||TWO_SIDED|80.0|-57.2|28.8||||||Week 52||28.8|-57.2|
71113933|NCT04683029|141735192|SUPERIORITY||LS Mean Difference|0.0|||||TWO_SIDED|80.0|-1.7|1.6||||||Week 24||1.6|-1.7|
71113934|NCT04683029|141735192|SUPERIORITY||LS Mean Difference|0.1|||||TWO_SIDED|80.0|-1.4|1.7||||||Week 52||1.7|-1.4|
71113935|NCT04683029|141735193|SUPERIORITY||LS Mean Difference|-0.08|||||TWO_SIDED|80.0|-0.44|0.27||||||Week 24||0.27|-0.44|
71113936|NCT04683029|141735193|SUPERIORITY||LS Mean Difference|0.21|||||TWO_SIDED|80.0|-0.29|0.71||||||Week 52||0.71|-0.29|
71113937|NCT04683029|141735194|SUPERIORITY||LS Mean Difference|-2.08|||||TWO_SIDED|80.0|-3.81|-0.34||||||Week 24||-0.34|-3.81|
71113938|NCT04683029|141735194|SUPERIORITY||LS Mean Difference|0.14|||||TWO_SIDED|80.0|-2.13|2.42||||||Week 52||2.42|-2.13|
71113939|NCT04683029|141735195|SUPERIORITY||LS Mean Difference|-4.9|||||TWO_SIDED|80.0|-5.7|-4.0||||||Week 24||-4.0|-5.7|
71113940|NCT04683029|141735195|SUPERIORITY||LS Mean Difference|-4.3|||||TWO_SIDED|80.0|-5.1|-3.5||||||Week 52||-3.5|-5.1|
71113941|NCT04683029|141735196|SUPERIORITY||LS Mean Difference|-0.4006|||||TWO_SIDED|80.0|-0.5344|-0.2668||||||Week 24||-0.2668|-0.5344|
71113942|NCT04683029|141735196|SUPERIORITY||LS Mean Difference|-0.2355|||||TWO_SIDED|80.0|-0.373|-0.098||||||Week 52||-0.0980|-0.3730|
71113943|NCT00814580|141735211|NON_INFERIORITY_OR_EQUIVALENCE|Primary hypothesis test for non-inferiority of tapentadol IR over oxycodone IR required that upper limit of 95% CI for LS mean difference (oxycodone IR minus tapentadol IR) was less than the inferiority margin (\< 72). If the upper limit was less than 0 then tapentadol IR was superior to oxycodone IR for SPID over 3 days at a 5% level of significance.|Least square mean difference|9.0|STANDARD_ERROR_OF_MEAN|14.2||0.5265|TWO_SIDED|95.0|-18.9|36.9||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||Tapentadol IR versus Oxycodone IR||36.9|-18.9|0.5265
71113944|NCT00814580|141735212|SUPERIORITY_OR_OTHER|||||||0.7306||95.0|||||Log Rank|||||||0.7306
71113945|NCT00814580|141735213|SUPERIORITY_OR_OTHER|||||||0.8524||95.0|||||Log Rank|||||||0.8524
71113946|NCT00814580|141735214|SUPERIORITY_OR_OTHER|||||||0.9078||95.0||||Cochran-Mantel-Haenszel test (Row Mean Score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel|||||||0.9078
71113947|NCT00814580|141735215|SUPERIORITY_OR_OTHER|||||||0.2633||95.0||||Cochran-Mantel-Haenszel test (Row Mean Score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel|||||||0.2633
71113948|NCT00814580|141735216|SUPERIORITY_OR_OTHER|||||||0.4498||95.0||||Cochran-Mantel-Haenszel test (Row Mean Score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel|||||||0.4498
71071076|NCT02045862|141651022|SUPERIORITY||Least Squares Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.69|-0.21||The 2-sided P value was for pairwise comparisons between the combination therapy group and the corresponding monotherapy group from the stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.21|-0.69|<0.001
71071077|NCT02045862|141651022|SUPERIORITY||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.12||0.002|TWO_SIDED|95.0|-0.37|0.11||The 2-sided P value was for pairwise comparisons between the combination therapy group and the corresponding monotherapy group from the stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.11|-0.37|0.002
71071078|NCT02045862|141651023|SUPERIORITY||Least Squares Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.77|-0.2||The 2-sided P value was for pairwise comparisons between the combination therapy group and the corresponding monotherapy group from the ANCOVA model.|ANCOVA|||Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.20|-0.77|<0.001
71071079|NCT02045862|141651023|SUPERIORITY||Least Squares Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.15||0.004|TWO_SIDED|95.0|-0.71|-0.13||The 2-sided P value was for pairwise comparisons between the combination therapy group and the corresponding monotherapy group from the ANCOVA model.|ANCOVA|||Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.13|-0.71|0.004
71071080|NCT02045862|141651024|SUPERIORITY||Least Squares Mean Difference|15.84|STANDARD_ERROR_OF_MEAN|3.49|<|0.001|TWO_SIDED|95.0|8.99|22.69|||ANCOVA|||Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||22.69|8.99|<0.001
71071081|NCT02045862|141651024|SUPERIORITY||Least Squares Mean Difference|12.77|STANDARD_ERROR_OF_MEAN|3.47|<|0.001|TWO_SIDED|95.0|5.98|19.57|||ANCOVA|||Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||19.57|5.98|<0.001
71071082|NCT02045862|141651025|SUPERIORITY||Least Squares Mean Difference|-7.55|STANDARD_ERROR_OF_MEAN|1.27|<|0.001|TWO_SIDED|95.0|-10.05|-5.05|||ANCOVA|||Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-5.05|-10.05|<0.001
71071083|NCT02045862|141651025|SUPERIORITY||Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|1.27|<|0.001|TWO_SIDED|95.0|-7.09|-2.12|||ANCOVA|||Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-2.12|-7.09|<0.001
71071084|NCT02045862|141651026|SUPERIORITY||Least Squares Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|0.28|0.82|||ANCOVA|||Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.82|0.28|<0.001
71113949|NCT00814580|141735217|SUPERIORITY_OR_OTHER|||||||0.2158||95.0||||Cochran-Mantel-Haenszel test (Row Mean Score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel|||||||0.2158
71113950|NCT00814580|141735218|SUPERIORITY_OR_OTHER||Least square mean difference|6.6|STANDARD_ERROR_OF_MEAN|9.34||0.4811|TWO_SIDED|95.0|-11.8|25.0||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||25.0|-11.8|0.4811
71113951|NCT00814580|141735219|SUPERIORITY_OR_OTHER||Least square mean difference|-9.3|STANDARD_ERROR_OF_MEAN|28.13||0.7405|TWO_SIDED|95.0|-64.7|46.0||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||46.0|-64.7|0.7405
71113952|NCT00814580|141735220|SUPERIORITY_OR_OTHER||Least square mean difference|-5.6|STANDARD_ERROR_OF_MEAN|5.53||0.3097|TWO_SIDED|95.0|-16.5|5.3||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||5.3|-16.5|0.3097
71113953|NCT00814580|141735221|SUPERIORITY_OR_OTHER||Least square mean difference|-10.3|STANDARD_ERROR_OF_MEAN|8.34||0.2179|TWO_SIDED|95.0|-26.7|6.1||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||6.1|-26.7|0.2179
71113954|NCT00814580|141735222|SUPERIORITY_OR_OTHER||Least square mean difference|-26.3|STANDARD_ERROR_OF_MEAN|16.16||0.1051|TWO_SIDED|95.0|-58.1|5.5||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||5.5|-58.1|0.1051
71113955|NCT00814580|141735223|SUPERIORITY_OR_OTHER||Least square mean difference|1.0|STANDARD_ERROR_OF_MEAN|12.09||0.9367|TWO_SIDED|95.0|-22.8|24.8||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||24.8|-22.8|0.9367
71113956|NCT00814580|141735224|SUPERIORITY_OR_OTHER||Least square mean difference|-1.3|STANDARD_ERROR_OF_MEAN|18.53||0.9441|TWO_SIDED|95.0|-37.8|35.2||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||35.2|-37.8|0.9441
71113957|NCT00814580|141735225|SUPERIORITY_OR_OTHER||Least square mean difference|-35.6|STANDARD_ERROR_OF_MEAN|37.45||0.3427|TWO_SIDED|95.0|-109.3|38.1||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||38.1|-109.3|0.3427
70939261|NCT03345407|141379317|OTHER||Posterior median odds ratio|1.11|||||TWO_SIDED|95.0|0.63|1.77|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.77|0.63|
70939262|NCT03345407|141379317|OTHER||Posterior median odds ratio|1.41|||||TWO_SIDED|95.0|0.77|2.17|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.17|0.77|
71071085|NCT02045862|141651026|SUPERIORITY||Least Squares Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|0.32|0.86|||ANCOVA|||Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.86|0.32|<0.001
71113958|NCT00814580|141735226|SUPERIORITY_OR_OTHER|||||||0.1618||95.0||||Cochran-Mantel-Haenszel test (row mean score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel|||||||0.1618
71113959|NCT00814580|141735227|SUPERIORITY_OR_OTHER|||||||0.0481||95.0||||Cochran-Mantel-Haenszel test (row mean score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel|||||||0.0481
71113960|NCT00814580|141735228|SUPERIORITY_OR_OTHER|||||||0.0109||95.0||||Cochran-Mantel-Haenszel test (row mean score option) controlling for pooled investigator centers|Cochran-Mantel-Haenszel|||||||0.0109
71113961|NCT02482428|141735245|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|p value is provided|Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.07||0.862|TWO_SIDED|90.0|-0.03|0.2|||Posterior mean|||||0.20|-0.03|0.862
71113962|NCT02482428|141735245|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|p value is provided|Mean Difference (Net)|0.02|STANDARD_DEVIATION|0.07||0.541|TWO_SIDED|90.0|-0.07|0.19|||posterior mean|||||0.19|-0.07|0.541
71113963|NCT04075292|141735254|SUPERIORITY||Hazard Ratio (HR)|0.08|||<|0.0001|TWO_SIDED|95.0|0.03|0.18|||Log Rank|The analysis was performed using the unstratified log-rank test.|HR was calculated using an unstratified Cox model with treatment as the only covariate. The CI for HR was calculated using the profile likelihood method.|||0.18|0.03|<0.0001
71113964|NCT00501592|141735279|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||The primary endpoints are calculated as the change (post minus pre treatment) during low dose and high dose insulin infusion periods. These are compared between placebo and INT-747 25 mg using t-tests for independent samples. These tests will be made without correction for multiple comparisons using 0.05 as the alpha criterion for significance. Results will be described with the corresponding means and standard deviations.||||0.040
71113965|NCT00501592|141735279|SUPERIORITY_OR_OTHER|||||||0.28|||||||t-test, 2 sided|||The primary endpoints are calculated as the change (post minus pre treatment) during low dose and high dose insulin infusion periods. These are compared between placebo and INT-747 50 mg using t-tests for independent samples. These tests will be made without correction for multiple comparisons using 0.05 as the alpha criterion for significance. Results will be described with the corresponding means and standard deviations.||||0.28
71113966|NCT00501592|141735280|SUPERIORITY_OR_OTHER|||||||0.0031||95.0|||||t-test, 2 sided|||||||0.0031
71113967|NCT00501592|141735280|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||||||>0.05
71113968|NCT00501592|141735280|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||t-test, 2 sided|||||||0.0001
71113969|NCT00501592|141735280|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||t-test, 2 sided|||||||0.0005
71113970|NCT00241176|141735313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003|||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)||YGTSS Global Severity score (M=61.8 SD=13.49) declined significantly to end point (M=33.7 SD=15.18; p=0.003).|Group 1 Baseline vs. Endpoint||||<.05
71113971|NCT00241176|141735314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)||Mean (SD) CGI-Tic severity scores reduced significantly from (M=4.45 SD=0.52) (moderate-marked) at baseline to (M=3.18 SD =0.60) (mild) at end point ( p=0.004).|Mean scores baseline to endpoint||||<.05
71113972|NCT03206970|141735332|OTHER||Clopper-Pearson|83.7|||<|0.0001|TWO_SIDED|95.0|74.2|90.8|||Binomial Exact Test|||A binomial exact test was performed to test against the null hypothesis H0: ORR=0.40 using the significant level of 0.025 (1-sided)||90.8|74.2|<.0001
71113973|NCT03206970|141735336|SUPERIORITY||Clopper-Pearson|83.7|||<|0.0001|TWO_SIDED|95.0|74.2|90.8|||Binomial Exact Test|||A binomial exact test was performed to test against the null hypothesis H0: ORR=0.40 using the significant level of 0.025 (1-sided)||90.8|74.2|<0.0001
71113974|NCT02516982|141735339|SUPERIORITY|||||||0.994|||||||Chi-squared, Corrected|||||||0.994
71113975|NCT02516982|141735340|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.7
71113976|NCT02516982|141735341|SUPERIORITY|||||||0.008|||||||Chi-squared, Corrected|||||||0.008
71071086|NCT02045862|141651028|SUPERIORITY||Rate Ratio|0.67|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|0.54|0.84|||Mixed Effects Poisson-Negative Binomial|||Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of incontinence episodes divided by number of valid diary days) at baseline included as a covariate and number of valid diary day at EoT as the offset variable.||0.84|0.54|<0.001
71113977|NCT02516982|141735342|SUPERIORITY|||||||0.919|||||||Chi-squared, Corrected|||||||0.919
71113978|NCT02516982|141735343|SUPERIORITY|||||||0.0001467|||||||Chi-squared, Corrected|||||||0.0001467
71113979|NCT02516982|141735344|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||||||0.024
71113980|NCT02516982|141735345|SUPERIORITY|||||||0.869|||||||Chi-squared, Corrected|||||||0.869
71113981|NCT01129765|141735349|SUPERIORITY_OR_OTHER||Proportion|0.97|||||TWO_SIDED|95.0|0.83|1.0|||Descriptive|||Proportion responding \>=3 on a 5-point likert scale, with exact 95% confidence interval from the binomial distribution.||1.0|0.83|
71113982|NCT01129765|141735350|SUPERIORITY_OR_OTHER||Proportion|0.97|||||TWO_SIDED|95.0|0.83|1.0|||Descriptive|||Descriptive summary of proportion responding \>=3 on 5-point Likert scale, with exact 95% confidnce interval from the binomial distribution.||1.0|0.83|
70852889|NCT03745820|141194619|SUPERIORITY||LS Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|1.032|=|0.6349|TWO_SIDED|95.0|-1.55|2.53|||MMRM|||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.||2.53|-1.55|=0.6349
70852890|NCT03745820|141194620|SUPERIORITY||LS Mean Difference|0.45|STANDARD_ERROR_OF_MEAN|1.345|=|0.7372|TWO_SIDED|95.0|-2.21|3.11||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Verbal Learning: Change From Baseline at Week 12||3.11|-2.21|=0.7372
70939263|NCT03345407|141379317|OTHER||Posterior median odds ratio|1.28|||||TWO_SIDED|95.0|0.71|2.0|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.00|0.71|
71071087|NCT02045862|141651028|SUPERIORITY||Rate Ratio|0.77|STANDARD_ERROR_OF_MEAN|0.12||0.029|TWO_SIDED|95.0|0.61|0.97|||Mixed Effects Poisson-Negative Binomial|||Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of incontinence episodes divided by number of valid diary days) at baseline included as a covariate and number of valid diary day at EoT as the offset variable.||0.97|0.61|0.029
71071088|NCT02045862|141651029|SUPERIORITY||Least Squares Mean Difference|-3.12|STANDARD_ERROR_OF_MEAN|0.83|<|0.001|TWO_SIDED|95.0|-4.76|-1.49||The two-sided p-value is for pairwise comparisons between the combination therapy group and the mirabegron monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-1.49|-4.76|<0.001
71113983|NCT01129765|141735351|SUPERIORITY_OR_OTHER||Proportion|0.97||||0.0005|TWO_SIDED|95.0|0.83|1.0|||One-sample proportion|||"Null hypothesis: Pr ≤ 0.7 versus HA: Pr \> 0.7; Pr is proportion using device appropriately. Observed rate calculated with exact 95% confidence interval from the binomial distribution. 2-sided p-value from binomial distribution.~With the proposed sample size of 30 subjects, we will reject the primary null hypothesis if at least 27 are observed to use the device properly. We will have 80% power for this to occur provided that the true rate in the population is at least 92%."||1.0|0.83|0.0005
71113984|NCT01129765|141735352|SUPERIORITY_OR_OTHER||Proportion|1.0|||||TWO_SIDED|95.0|0.88|1.0|||Descriptive|||Descriptive summary of proportion responding \>=3 on a 5-point Likert scale, with exact 95% confidnce interval from the binomial distribution.||1.0|0.88|
71113985|NCT01129765|141735353|SUPERIORITY_OR_OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|0.12|||Descriptive|||Descriptive summary of proportion observed to have a safety issue, with exact 95% confidnce interval from the binomial distribution.||0.12|0|
71113986|NCT01129765|141735354|SUPERIORITY_OR_OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|0.12|||Descriptive|||Descriptive summary of proportion found to have injury, with exact 95% confidnce interval from the binomial distribution.||0.12|0|
70939264|NCT03345407|141379317|OTHER||Posterior median odds ratio|1.11|||||TWO_SIDED|95.0|0.61|1.75|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.75|0.61|
70939265|NCT03345407|141379317|OTHER||Posterior median odds ratio|0.7|||||TWO_SIDED|95.0|0.46|0.99|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||0.99|0.46|
70939266|NCT03345407|141379317|OTHER||Posterior median odds ratio|0.64|||||TWO_SIDED|95.0|0.2|1.41|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.41|0.20|
70939267|NCT03345407|141379317|OTHER||Posterior median odds ratio|1.53|||||TWO_SIDED|95.0|0.84|2.46|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.46|0.84|
70939268|NCT03345407|141379317|OTHER||Posterior median odds ratio|0.95|||||TWO_SIDED|95.0|0.53|1.48|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.48|0.53|
70939269|NCT03345407|141379317|OTHER||Posterior median odds ratio|1.36|||||TWO_SIDED|95.0|0.74|2.16|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.16|0.74|
70939270|NCT03345407|141379317|OTHER||Posterior median odds ratio|0.76|||||TWO_SIDED|95.0|0.43|1.17|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.17|0.43|
70939271|NCT03345407|141379317|OTHER||Posterior median odds ratio|0.93|||||TWO_SIDED|95.0|0.63|1.27|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.27|0.63|
70939272|NCT03345407|141379317|OTHER||Posterior median odds ratio|0.54|||||TWO_SIDED|95.0|0.16|1.2|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.20|0.16|
70939273|NCT03345407|141379317|OTHER||Posterior median odds ratio|1.53|||||TWO_SIDED|95.0|0.79|2.56|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.56|0.79|
70939274|NCT03345407|141379317|OTHER||Posterior median odds ratio|0.83|||||TWO_SIDED|95.0|0.46|1.3|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.30|0.46|
70939275|NCT03345407|141379317|OTHER||Posterior median odds ratio|1.16|||||TWO_SIDED|95.0|0.62|1.86|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.86|0.62|
70939276|NCT03345407|141379317|OTHER||Posterior median odds ratio|0.65|||||TWO_SIDED|95.0|0.36|1.02|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.02|0.36|
70939277|NCT03345407|141379317|OTHER||Posterior median odds ratio|0.85|||||TWO_SIDED|95.0|0.57|1.17|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.17|0.57|
70939278|NCT03345407|141379318|OTHER||Posterior adjusted median difference|2.4|||||TWO_SIDED|95.0|-0.5|5.2|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||5.2|-0.5|
70939279|NCT03345407|141379318|OTHER||Posterior adjusted median difference|0.7|||||TWO_SIDED|95.0|-0.8|2.3|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.3|-0.8|
70939280|NCT03345407|141379318|OTHER||Posterior adjusted median difference|0.8|||||TWO_SIDED|95.0|-0.8|2.4|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.4|-0.8|
70939281|NCT03345407|141379318|OTHER||Posterior adjusted median difference|-0.3|||||TWO_SIDED|95.0|-2.0|1.2|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.2|-2.0|
70939282|NCT03345407|141379318|OTHER||Posterior adjacent median difference|1.6|||||TWO_SIDED|95.0|0.0|3.3|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||3.3|0.0|
70939283|NCT03345407|141379318|OTHER||Posterior adjusted median difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.1|-1.1|
70939284|NCT03345407|141379318|OTHER||Posterior adjusted median difference|2.3|||||TWO_SIDED|95.0|-0.5|5.4|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||5.4|-0.5|
70939285|NCT03345407|141379318|OTHER||Posterior adjusted median difference|0.8|||||TWO_SIDED|95.0|-0.9|2.4|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.4|-0.9|
70939286|NCT03345407|141379318|OTHER||Posterior adjusted median difference|-0.3|||||TWO_SIDED|95.0|-1.9|1.4|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.4|-1.9|
70939287|NCT03345407|141379318|OTHER||Posterior adjusted median difference|-0.5|||||TWO_SIDED|95.0|-2.3|1.0|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.0|-2.3|
70939288|NCT03345407|141379318|OTHER||Posterior adjusted median difference|0.4|||||TWO_SIDED|95.0|-1.2|2.2|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.2|-1.2|
70939289|NCT03345407|141379318|OTHER||Posterior adjusted median difference|-0.2|||||TWO_SIDED|95.0|-1.4|1.0|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.0|-1.4|
70939290|NCT03345407|141379318|OTHER||Posterior adjusted median difference|1.9|||||TWO_SIDED|95.0|-1.4|5.1|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||5.1|-1.4|
70939291|NCT03345407|141379318|OTHER||Posterior adjusted median difference|1.1|||||TWO_SIDED|95.0|-0.7|2.8|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.8|-0.7|
70939292|NCT03345407|141379318|OTHER||Posterior adjusted median difference|-0.5|||||TWO_SIDED|95.0|-2.3|1.1|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 84 was performed and posterior adjsted median difference and 95% HPD CrI has been presented.|||1.1|-2.3|
70939293|NCT03345407|141379318|OTHER||Posterior adjusted median difference|-0.1|||||TWO_SIDED|95.0|-1.9|1.7|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.7|-1.9|
70939294|NCT03345407|141379318|OTHER||Posterior adjusted median difference|0.8|||||TWO_SIDED|95.0|-0.9|2.8|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.8|-0.9|
71071089|NCT02045862|141651029|SUPERIORITY||Least Squares Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.84|<|0.001|TWO_SIDED|95.0|-2.57|0.72||The two-sided p-value is for pairwise comparisons between the combination therapy group and the solifenacin monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.72|-2.57|<0.001
71071090|NCT02045862|141651030|SUPERIORITY||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.26|2.01|||Overdispersed Binomial Regression|||Odds ratio vs. Mirabegron 50 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours as a covariate||2.01|1.26|<0.001
71071091|NCT02045862|141651030|SUPERIORITY||Odds Ratio (OR)|1.38||||0.009|TWO_SIDED|95.0|1.08|1.75|||Overdispersed Binomial Regression|||Odds ratio vs. Solifenacin 5 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours as a covariate.||1.75|1.08|0.009
71071092|NCT02045862|141651031|SUPERIORITY||Odds Ratio (OR)|1.61|||<|0.001|TWO_SIDED|95.0|1.26|2.05|||Overdispersed Binomial Regression|||Odds ratio vs. Mirabegron 50 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours and baseline mean number of micturitions per 24 hours as a covariates.||2.05|1.26|<0.001
71071093|NCT02045862|141651031|SUPERIORITY||Odds Ratio (OR)|1.45||||0.002|TWO_SIDED|95.0|1.14|1.85|||Overdispersed Binomial Regression|||Odds ratio vs. Solifenacin 5 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours and baseline mean number of micturitions per 24 hours as a covariates.||1.85|1.14|0.002
71071094|NCT02045862|141651032|SUPERIORITY||Least Squares Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.65|-0.21||The two-sided p-value is for pairwise comparisons between the combination therapy group and the mirabegron monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.21|-0.65|<0.001
71113987|NCT01814878|141735446|NON_INFERIORITY_OR_EQUIVALENCE|Study drug treatment group was considered non-inferior to comparator treatment group, if lower limit of the confidence interval was larger than -2.0|Mean Difference (Final Values)|-4.68||||0.1648|TWO_SIDED|95.0|-11.29|1.93||Hour 48: P-value was calculated using Student's t-test|Student's t-test|||Non-inferiority comparison for Tramadol Hydrochloride/Acetaminophen ER to Tramadol HCl/Acetaminophen IR was performed.||1.93|-11.29|0.1648
71113988|NCT01814878|141735447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.4082|TWO_SIDED|95.0|-1.1|0.45||Hour 6: P-value was calculated using Student's t-test|Student's t-test|||||0.45|-1.10|0.4082
71113989|NCT01814878|141735447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.172|TWO_SIDED|95.0|-2.68|0.48||Hour 12: P-value was calculated using Student's t-test|Student's t-test|||||0.48|-2.68|0.1720
70852891|NCT03745820|141194620|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|1.346|=|0.6894|TWO_SIDED|95.0|-3.2|2.12||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Verbal Learning: Change From Baseline at Week 12||2.12|-3.20|=0.6894
70939295|NCT03345407|141379318|OTHER||Posterior adjusted median difference|0.4|||||TWO_SIDED|95.0|-0.8|1.7|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.7|-0.8|
70939296|NCT03345407|141379319|OTHER||Posterior median odds ratio|0.51|||||TWO_SIDED|95.0|0.03|1.41|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.41|0.03|
70939297|NCT03345407|141379319|OTHER||Posterior median odds ratio|0.87|||||TWO_SIDED|95.0|0.42|1.47|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.47|0.42|
70939298|NCT03345407|141379319|OTHER||Posterior median odds ratio|1.37|||||TWO_SIDED|95.0|0.69|2.24|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.24|0.69|
70939299|NCT03345407|141379319|OTHER||Posterior median odds ratio|1.78|||||TWO_SIDED|95.0|0.95|2.91|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.91|0.95|
71071095|NCT02045862|141651032|SUPERIORITY||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.11||0.009|TWO_SIDED|95.0|-0.36|0.09||The two-sided p-value is for pairwise comparisons between the combination therapy group and the solifenacin monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate||0.09|-0.36|0.009
71071096|NCT02045862|141651033|SUPERIORITY||Rate Ratio|0.62|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|0.48|0.79|||Negative Binomial Regression|||Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥65 years), geographic region and previous study history as factors, log(number of urgency incontinence episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary days at EoT as the offset variable||0.79|0.48|<0.001
71071097|NCT02045862|141651033|SUPERIORITY||Rate Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.13||0.023|TWO_SIDED|95.0|0.58|0.96|||Negative Binomial Regression|||Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group is calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of urgency incontinence episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary day at EoT as the offset variable||0.96|0.58|0.023
71071098|NCT02045862|141651034|SUPERIORITY||Least Squares Mean Difference|-2.98|STANDARD_ERROR_OF_MEAN|0.78|<|0.001|TWO_SIDED|95.0|-4.51|-1.46||The two-sided p-value is for pairwise comparisons between the combination therapy group and the mirabegron monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-1.46|-4.51|<0.001
71071099|NCT02045862|141651034|SUPERIORITY||Stratified Rank ANCOVA|-0.93|STANDARD_ERROR_OF_MEAN|0.78||0.006|TWO_SIDED|95.0|-2.47|0.61||The two-sided p-value is for pairwise comparisons between the combination therapy group and the solifenacin monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.61|-2.47|0.006
71071100|NCT02045862|141651036|SUPERIORITY||Odds Ratio (OR)|1.44||||0.002|TWO_SIDED|95.0|1.14|1.8|||Overdispersed Binomial Regression|||Odds ratio vs. Mirabegron 50 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.8|1.14|0.002
71071101|NCT02045862|141651036|SUPERIORITY||Odds Ratio (OR)|1.37||||0.007|TWO_SIDED|95.0|1.09|1.73|||Overdispersed Binomial Regression|||Odds ratio vs. Solifenacin 5 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.73|1.09|0.007
71071102|NCT02045862|141651037|SUPERIORITY||Least Squares Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.16|-0.41|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.||-0.41|-1.16|<0.001
71071103|NCT02045862|141651037|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.037|TWO_SIDED|95.0|-0.77|-0.02|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.||-0.02|-0.77|0.037
71113990|NCT01814878|141735447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.99||||0.0589|TWO_SIDED|95.0|-6.09|0.11||Hour 24: P-value was calculated using Student's t-test|Student's t-test|||||0.11|-6.09|0.0589
71113991|NCT01814878|141735448|SUPERIORITY_OR_OTHER|||||||0.1542||||||Hour 6: P-value was calculated using Student's t-test|Student's t-test|||||||0.1542
70939300|NCT03345407|141379319|OTHER||Posterior median odds ratio|1.24|||||TWO_SIDED|95.0|0.61|2.08|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.08|0.61|
71113992|NCT01814878|141735448|SUPERIORITY_OR_OTHER|||||||0.0714||||||Hour 12: P-value was calculated using Student's t-test|Student's t-test|||||||0.0714
71113993|NCT01814878|141735448|SUPERIORITY_OR_OTHER|||||||0.1147||||||Hour 24: P-value was calculated using Student's t-test|Student's t-test|||||||0.1147
71113994|NCT01814878|141735448|SUPERIORITY_OR_OTHER|||||||0.2209||||||Hour 48: P-value was calculated using Student's t-test|Student's t-test|||||||0.2209
71113995|NCT01814878|141735449|SUPERIORITY_OR_OTHER|||||||0.1498||||||Hour 6: P-value was calculated using Student's t-test|Student's t-test|||||||0.1498
70939301|NCT03345407|141379319|OTHER||Posterior median odds ratio|0.95|||||TWO_SIDED|95.0|0.6|1.4|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.40|0.60|
70939302|NCT03345407|141379319|OTHER||Posterior median odds ratio|0.54|||||TWO_SIDED|95.0|0.14|1.16|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.16|0.14|
71113996|NCT01814878|141735449|SUPERIORITY_OR_OTHER|||||||0.0485||||||Hour 12: P-value was calculated using Student's t-test|Student's t-test|||||||0.0485
71113997|NCT01814878|141735449|SUPERIORITY_OR_OTHER|||||||0.0404||||||Hour 24: P-value was calculated using Student's t-test|Student's t-test|||||||0.0404
71071104|NCT02045862|141651039|SUPERIORITY||Least Squares Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.1|-0.37|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.37|-1.10|<0.001
71071105|NCT02045862|141651039|SUPERIORITY||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.19||0.036|TWO_SIDED|95.0|-0.76|-0.03|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.03|-0.76|0.036
71071106|NCT02045862|141651040|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.059|TWO_SIDED|95.0|-0.19|0.0|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.00|-0.19|0.059
71071107|NCT02045862|141651040|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.068|TWO_SIDED|95.0|-0.19|0.01|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.01|-0.19|0.068
71071108|NCT02045862|141651041|SUPERIORITY||Rate Ratio|0.9|STANDARD_ERROR_OF_MEAN|0.06||0.067|TWO_SIDED|95.0|0.81|1.01|||Negative Binomial Regression|||Rate ratio of number of nocturia episodes during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of nocturia episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary days as the offset variable||1.01|0.81|0.067
71071109|NCT02045862|141651041|SUPERIORITY||Rate Ratio|0.92|STANDARD_ERROR_OF_MEAN|0.06||0.131||95.0|0.82|1.03|||Negative Binomial Regression|||Rate ratio of number of nocturia episodes during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of nocturia episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary day as the offset variable.||1.03|0.82|0.131
71071110|NCT02045862|141651042|SUPERIORITY||Least Squares Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.35||0.055|TWO_SIDED|95.0|-1.34|0.01|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.01|-1.34|0.055
71071111|NCT02045862|141651042|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.35||0.048|TWO_SIDED|95.0|-1.39|-0.01|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.01|-1.39|0.048
71113998|NCT01814878|141735449|SUPERIORITY_OR_OTHER|||||||0.121||||||Hour 48: P-value was calculated using Student's t-test|Student's t-test|||||||0.1210
71113999|NCT01814878|141735450|SUPERIORITY_OR_OTHER|||||||0.4216||||||P-value was calculated using Mann-Whitney's U test.|Wilcoxon (Mann-Whitney)|||||||0.4216
71071112|NCT02045862|141651043|SUPERIORITY||Least Squares Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.13||0.002|TWO_SIDED|95.0|-0.69|-0.16|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.16|-0.69|0.002
71071113|NCT02045862|141651043|SUPERIORITY||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.14||0.039|TWO_SIDED|95.0|-0.55|-0.01|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.01|-0.55|0.039
71114000|NCT01814878|141735451|SUPERIORITY_OR_OTHER|||||||0.1||||||P-value was calculated using Mann-Whitney's U test.|Wilcoxon (Mann-Whitney)|||||||0.1000
71114001|NCT01814878|141735452|SUPERIORITY_OR_OTHER|||||||0.3255||||||P-value was calculated using Mann-Whitney's U test.|Wilcoxon (Mann-Whitney)|||||||0.3255
71114002|NCT01814878|141735453|SUPERIORITY_OR_OTHER|||||||0.2848||||||Day 3: P-value was calculated using student's t-test|Student's t-test|||||||0.2848
71114003|NCT03645421|141735456|OTHER||Least squares (LS) mean difference|-42.11|STANDARD_ERROR_OF_MEAN|4.16|<|0.0001|TWO_SIDED|95.0|-50.47|-33.75|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 100 mcg - Placebo|Pair-wise comparison of MEDI0382 100 mcg versus Placebo.||-33.75|-50.47|<0.0001
71071114|NCT02045862|141651044|SUPERIORITY||Rate Ratio|0.58|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|0.45|0.76|||Negative Binomial Regression|||Rate ratio vs. Mirabegron 50 mg (EoT): Rate ratio of number of pads during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group is calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of pads divided by number of valid diary days) included as a covariate and post baseline number of valid diary days as the offset variable.||0.76|0.45|<0.001
71071115|NCT02045862|141651044|SUPERIORITY||Rate Ratio|0.76|STANDARD_ERROR_OF_MEAN|0.14||0.044|TWO_SIDED|95.0|0.58|0.99|||Negative Binomial Regression|||Rate ratio vs. Solifenacin 5 mg (EoT): Rate ratio of number of pads during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group is calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of pads divided by number of valid diary days) included as a covariate and post baseline number of valid diary days as the offset variable.||0.99|0.58|0.044
71071116|NCT02045862|141651045|SUPERIORITY||Least Squares Mean Difference|-2.98|STANDARD_ERROR_OF_MEAN|0.92||0.001|TWO_SIDED|95.0|-4.78|-1.18|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-1.18|-4.78|0.001
71071117|NCT02045862|141651045|SUPERIORITY||Least Squares Mean Difference|-1.68|STANDARD_ERROR_OF_MEAN|0.93||0.072|TWO_SIDED|95.0|-3.52|0.15|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.15|-3.52|0.072
71071118|NCT02045862|141651047|SUPERIORITY||Least Squares Mean Difference|4.76|STANDARD_ERROR_OF_MEAN|1.12|<|0.001|TWO_SIDED|95.0|2.56|6.96|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||6.96|2.56|<0.001
71071119|NCT02045862|141651047|SUPERIORITY||Least Squares Mean Difference|2.86|STANDARD_ERROR_OF_MEAN|1.11||0.01|TWO_SIDED|95.0|0.68|5.04|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||5.04|0.68|0.010
71071120|NCT02045862|141651048|SUPERIORITY||Least Squares Mean Difference|5.6|STANDARD_ERROR_OF_MEAN|1.33|<|0.001|TWO_SIDED|95.0|2.99|8.2|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||8.20|2.99|<0.001
71071121|NCT02045862|141651048|SUPERIORITY||Least Squares Mean Difference|3.01|STANDARD_ERROR_OF_MEAN|1.32||0.022|TWO_SIDED|95.0|0.43|5.6|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||5.60|0.43|0.022
71114004|NCT03645421|141735456|OTHER||LS mean difference|-33.61|STANDARD_ERROR_OF_MEAN|4.69|<|0.0001|TWO_SIDED|95.0|-43.04|-24.18|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 200 mcg - Placebo|Pair-wise comparison of MEDI0382 200 mcg versus Placebo.||-24.18|-43.04|<0.0001
71114005|NCT03645421|141735456|OTHER||LS mean difference|-40.3|STANDARD_ERROR_OF_MEAN|4.57|<|0.0001|TWO_SIDED|95.0|-49.49|-31.12|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 300 mcg - Placebo|Pair-wise comparison of MEDI0382 300 mcg versus Placebo.||-31.12|-49.49|<0.0001
71114006|NCT03645421|141735457|OTHER||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.89||0.1476|TWO_SIDED|95.0|-3.08|0.47|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 100 mcg - Placebo|Pair-wise comparison of MEDI0382 100 mcg versus Placebo.||0.47|-3.08|0.1476
71114007|NCT03645421|141735457|OTHER||LS mean difference|-2.53|STANDARD_ERROR_OF_MEAN|0.92||0.008|TWO_SIDED|95.0|-4.37|-0.69|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 200 mcg - Placebo|Pair-wise comparison of MEDI0382 200 mcg versus Placebo.||-0.69|-4.37|0.0080
71114008|NCT03645421|141735457|OTHER||LS mean difference|-2.52|STANDARD_ERROR_OF_MEAN|0.89||0.0063|TWO_SIDED|95.0|-4.3|-0.74|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 300 mcg - Placebo|Pair-wise comparison of MEDI0382 300 mcg versus Placebo.||-0.74|-4.30|0.0063
71071122|NCT02045862|141651049|SUPERIORITY||Least Squares Mean Difference|5.01|STANDARD_ERROR_OF_MEAN|1.21|<|0.001|TWO_SIDED|95.0|2.65|7.38|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||7.38|2.65|<0.001
71114009|NCT03645421|141735460|OTHER||LS mean difference|-1.09|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.48|-0.7|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 100 mcg - Placebo|Pair-wise comparison of MEDI0382 100 mcg versus Placebo.||-0.70|-1.48|<0.0001
70852892|NCT03745820|141194620|SUPERIORITY||LS Mean Difference|-2.14|STANDARD_ERROR_OF_MEAN|1.162|=|0.0674|TWO_SIDED|95.0|-4.44|0.16||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Speed of Processing: Change From Baseline at Week 12||0.16|-4.44|=0.0674
70939303|NCT03345407|141379319|OTHER||Posterior median odds ratio|1.27|||||TWO_SIDED|95.0|0.74|1.98|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.98|0.74|
71071123|NCT02045862|141651049|SUPERIORITY||Least Squares Mean Difference|3.78|STANDARD_ERROR_OF_MEAN|1.2||0.002|TWO_SIDED|95.0|1.43|6.13|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||6.13|1.43|0.002
71071124|NCT02045862|141651050|SUPERIORITY||Least Squares Mean Difference|5.15|STANDARD_ERROR_OF_MEAN|1.36|<|0.001|TWO_SIDED|95.0|2.47|7.83|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||7.83|2.47|<0.001
71071125|NCT02045862|141651050|SUPERIORITY||Least Squares Mean Difference|3.27|STANDARD_ERROR_OF_MEAN|1.35||0.016|TWO_SIDED|95.0|0.62|5.93|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||5.93|0.62|0.016
71071126|NCT02045862|141651051|SUPERIORITY||Least Squares Mean Difference|2.68|STANDARD_ERROR_OF_MEAN|0.98||0.006|TWO_SIDED|95.0|0.77|4.59|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||4.59|0.77|0.006
71071127|NCT02045862|141651051|SUPERIORITY||Least Squares Mean Difference|1.03|STANDARD_ERROR_OF_MEAN|0.97||0.287|TWO_SIDED|95.0|-0.87|2.93|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||2.93|-0.87|0.287
71071128|NCT02045862|141651053|SUPERIORITY||Least Squares Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.47|-0.16|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.16|-0.47|<0.001
71071129|NCT02045862|141651053|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.011|TWO_SIDED|95.0|-0.36|-0.05|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.05|-0.36|0.011
71071130|NCT02045862|141651065|SUPERIORITY||Odds Ratio (OR)|1.65|||<|0.001|TWO_SIDED|95.0|1.26|2.15|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||2.15|1.26|<0.001
71071131|NCT02045862|141651065|SUPERIORITY||Odds Ratio (OR)|1.27||||0.08|TWO_SIDED|95.0|0.97|1.67|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.67|0.97|0.080
71071132|NCT02045862|141651066|SUPERIORITY||Odds Ratio (OR)|2.03|||<|0.001|TWO_SIDED|95.0|1.49|2.78|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline OAB-q subscale as a covariate.||2.78|1.49|<0.001
71071133|NCT02045862|141651066|SUPERIORITY||Odds Ratio (OR)|1.87|||<|0.001|TWO_SIDED|95.0|1.37|2.57|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline OAB-q subscale as a covariate.||2.57|1.37|<0.001
71114010|NCT03645421|141735460|OTHER||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.49|-0.71|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 200 mcg - Placebo|Pair-wise comparison of MEDI0382 200 mcg versus Placebo.||-0.71|-1.49|<0.0001
70939304|NCT03345407|141379319|OTHER||Posterior median odds ratio|1.29|||||TWO_SIDED|95.0|0.73|1.97|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.97|0.73|
70939305|NCT03345407|141379319|OTHER||Posterior median odds ratio|1.47|||||TWO_SIDED|95.0|0.83|2.27|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.27|0.83|
71071134|NCT02045862|141651067|SUPERIORITY||Odds Ratio (OR)|1.82|||<|0.001|TWO_SIDED|95.0|1.36|2.43|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline OAB-q subscale as a covariate.||2.43|1.36|<0.001
71071135|NCT02045862|141651067|SUPERIORITY||Odds Ratio (OR)|1.44||||0.014|TWO_SIDED|95.0|1.08|1.92|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline OAB-q subscale as a covariate.||1.92|1.08|0.014
71071136|NCT02045862|141651068|SUPERIORITY||Odds Ratio (OR)|1.8|||<|0.001|TWO_SIDED|95.0|1.34|2.41|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||2.41|1.34|<0.001
71071137|NCT02045862|141651068|SUPERIORITY||Odds Ratio (OR)|1.44||||0.019|TWO_SIDED|95.0|1.06|1.95|||Regression, Logistic|||Odds ratio wa from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||1.95|1.06|0.019
71071138|NCT02045862|141651069|SUPERIORITY||Odds Ratio (OR)|1.67|||<|0.001|TWO_SIDED|95.0|1.26|2.19|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||2.19|1.26|<0.001
71071139|NCT02045862|141651069|SUPERIORITY||Odds Ratio (OR)|1.23||||0.133|TWO_SIDED|95.0|0.94|1.62|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||1.62|0.94|0.133
71071140|NCT02045862|141651070|SUPERIORITY||Odds Ratio (OR)|1.55||||0.002|TWO_SIDED|95.0|1.18|2.03|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||2.03|1.18|0.002
71071141|NCT02045862|141651070|SUPERIORITY||Odds Ratio (OR)|1.48||||0.006|TWO_SIDED|95.0|1.12|1.95|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.95|1.12|0.006
71071142|NCT02045862|141651071|SUPERIORITY||Odds Ratio (OR)|1.68|||<|0.001|TWO_SIDED|95.0|1.24|2.29|||Regression, Logistic|||Odds ratio is from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline PPBC as a covariate.||2.29|1.24|<0.001
71071143|NCT02045862|141651071|SUPERIORITY||Odds Ratio (OR)|1.29||||0.109|TWO_SIDED|95.0|0.94|1.77|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline PPBC as a covariate.||1.77|0.94|0.109
71071144|NCT02045862|141651072|SUPERIORITY||Odds Ratio (OR)|1.69|||<|0.001|TWO_SIDED|95.0|1.26|2.25|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline PPBC as a covariate.||2.25|1.26|<0.001
71071145|NCT02045862|141651072|SUPERIORITY||Odds Ratio (OR)|1.62|||<|0.001|TWO_SIDED|95.0|1.22|2.16|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline PPBC as a covariate.||2.16|1.22|<0.001
71071146|NCT02045862|141651073|SUPERIORITY||Odds Ratio (OR)|1.99|||<|0.001|TWO_SIDED|95.0|1.5|2.62|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.||2.62|1.50|<0.001
70939306|NCT03345407|141379319|OTHER||Posterior median odds ratio|1.04|||||TWO_SIDED|95.0|0.57|1.62|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.62|0.57|
71071147|NCT02045862|141651073|SUPERIORITY||Odds Ratio (OR)|1.79|||<|0.001|TWO_SIDED|95.0|1.35|2.36|||Regression, Logistic|||Odds ratio is from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.||2.36|1.35|<0.001
71071148|NCT02045862|141651074|SUPERIORITY||Odds Ratio (OR)|1.93|||<|0.001|TWO_SIDED|95.0|1.46|2.54|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.||2.54|1.46|<0.001
71071149|NCT02045862|141651074|SUPERIORITY||Odds Ratio (OR)|1.59||||0.001|TWO_SIDED|95.0|1.2|2.09|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.||2.09|1.20|0.001
71071150|NCT02045862|141651075|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.28|2.26|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline PPBC as covariates.||2.26|1.28|<0.001
70939307|NCT03345407|141379319|OTHER||Posterior median odds ratio|1.1|||||TWO_SIDED|95.0|0.75|1.5|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.50|0.75|
70939308|NCT03345407|141379319|OTHER||Posterior median odds ratio|0.63|||||TWO_SIDED|95.0|0.17|1.39|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.39|0.17|
71071151|NCT02045862|141651075|SUPERIORITY||Odds Ratio (OR)|1.4||||0.019|TWO_SIDED|95.0|1.06|1.86|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline PPBC as covariates.||1.86|1.06|0.019
71071152|NCT02045862|141651076|SUPERIORITY||Odds Ratio (OR)|1.86|||<|0.001|TWO_SIDED|95.0|1.4|2.46|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.||2.46|1.40|<0.001
71071153|NCT02045862|141651076|SUPERIORITY||Odds Ratio (OR)|1.58||||0.001|TWO_SIDED|95.0|1.19|2.09|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.||2.09|1.19|0.001
71071154|NCT02045862|141651077|SUPERIORITY||Odds Ratio (OR)|1.76|||<|0.001|TWO_SIDED|95.0|1.33|2.34|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.||2.34|1.33|<0.001
71071155|NCT02045862|141651077|SUPERIORITY||Odds Ratio (OR)|1.43||||0.012|TWO_SIDED|95.0|1.08|1.89|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.||1.89|1.08|0.012
71071156|NCT02357706|141651089|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"We are testing the Hypothesis that there is a significant difference between CPAP A and CPAP B~The Null Hypothesis is H0 = One CPAP is inferior to the other CPAP The Alternate Hypothesis is H1 = There is no significant difference between the CPAPs"|Mean Difference (Final Values)|1.24||||0.537|TWO_SIDED||||||t-test, 1 sided|||"Comparison of AHI/ oxygen desaturation index (ODI) of Device A compared with Device B.~Efficacy is defined as a residual AHI and ODI on each night of the trial. PSG scored AHI and ODI will be collected on both trial nights (excluding the ramp period); and compared using the Paired T test"||||0.537
71071157|NCT02357706|141651089|NON_INFERIORITY|"We are testing the Hypothesis that there is a significant difference between CPAP A and CPAP B~The Null Hypothesis is H0 = One CPAP is inferior to the other CPAP The Alternate Hypothesis is H1 = There is no significant difference between the CPAPs~The expected difference mu is 0 events/hr The Non-Inferiority Margin delta is 0.75 events/hr (A difference of 1 event per hour is seen as clinically significant. 0.75 has been chosen to ensure any AHI change is seen)."|Mean Difference (Net)|1.24||||0.05|TWO_SIDED||||||t-test, 1 sided|||||||0.05
71114011|NCT03645421|141735460|OTHER||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.19||0.0002|TWO_SIDED|95.0|-1.15|-0.38|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 300 mcg - Placebo|Pair-wise comparison of MEDI0382 300 mcg versus Placebo.||-0.38|-1.15|0.0002
71114012|NCT03645421|141735461|OTHER||LS mean difference|-56.69|STANDARD_ERROR_OF_MEAN|8.75|<|0.0001|TWO_SIDED|95.0|-74.3|-39.09|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 100 mcg - Placebo|Pair-wise comparison of MEDI0382 100 mcg versus Placebo.||-39.09|-74.30|<0.0001
71114013|NCT03645421|141735461|OTHER||LS mean difference|-60.58|STANDARD_ERROR_OF_MEAN|9.92|<|0.0001|TWO_SIDED|95.0|-80.53|-40.63|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 200 mcg - Placebo|Pair-wise comparison of MEDI0382 200 mcg versus Placebo.||-40.63|-80.53|<0.0001
70939309|NCT03345407|141379319|OTHER||Posterior median odds ratio|1.27|||||TWO_SIDED|95.0|0.72|2.01|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.01|0.72|
70939310|NCT03345407|141379319|OTHER||Posterior median odds ratio|1.13|||||TWO_SIDED|95.0|0.64|1.79|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.79|0.64|
71114014|NCT03645421|141735461|OTHER||LS mean difference|-55.07|STANDARD_ERROR_OF_MEAN|9.55|<|0.0001|TWO_SIDED|95.0|-74.28|-35.86|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 300 mcg - Placebo|Pair-wise comparison of MEDI0382 300 mcg versus Placebo.||-35.86|-74.28|<0.0001
71114015|NCT03645421|141735462|OTHER||LS mean difference|-0.071|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|-0.094|-0.047|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 100 mcg - Placebo|Pair-wise comparison of MEDI0382 100 mcg versus Placebo.||-0.047|-0.094|<0.0001
70939311|NCT03345407|141379319|OTHER||Posterior median odds ratio|1.35|||||TWO_SIDED|95.0|0.75|2.14|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.14|0.75|
70939312|NCT03345407|141379319|OTHER||Posterior median odds ratio|0.94|||||TWO_SIDED|95.0|0.53|1.45|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.45|0.53|
70939313|NCT03345407|141379319|OTHER||Posterior median odds ratio|1.03|||||TWO_SIDED|95.0|0.71|1.43|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.43|0.71|
70939314|NCT03345407|141379320|OTHER||Posterior adjusted median difference|2.0|||||TWO_SIDED|95.0|-4.8|8.3|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||8.3|-4.8|
70939315|NCT03345407|141379320|OTHER||Posterior adjusted median difference|-0.5|||||TWO_SIDED|95.0|-4.0|3.1|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||3.1|-4.0|
71071158|NCT02357706|141651090|NON_INFERIORITY|"We are testing the Hypothesis that there is a significant difference between CPAP A and CPAP B~The Null Hypothesis is H0 = One CPAP is inferior to the other CPAP The Alternate Hypothesis is H1 = There is no significant difference between the CPAPs~The expected difference mu is 0 events/hr The Non-Inferiority Margin delta is 0.75 events/hr (A difference of 1 event per hour is seen as clinically significant. 0.75 has been chosen to ensure any AHI change is seen)."|Mean Difference (Net)|2.69||||0.205|TWO_SIDED||||||t-test, 1 sided|||||||0.205
71071159|NCT02357706|141651090|NON_INFERIORITY|"We are testing the Hypothesis that there is a significant difference between CPAP A and CPAP B~The Null Hypothesis is H0 = One CPAP is inferior to the other CPAP The Alternate Hypothesis is H1 = There is no significant difference between the CPAPs~The expected difference mu is 0 events/hr The Non-Inferiority Margin delta is 0.75 events/hr (A difference of 1 event per hour is seen as clinically significant. 0.75 has been chosen to ensure any AHI change is seen)."|Mean Difference (Net)|2.69||||0.134|TWO_SIDED||||||t-test, 1 sided|||||||0.134
71071160|NCT01895608|141651112|OTHER|non-parametric statistic: Mann-Whitney U test for independent samples||||||0.562|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in walking under dual-task conditions following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.||||0.562
71071161|NCT01895608|141651112|OTHER|||||||0.414|||||||Wilcoxon (Mann-Whitney)|non-parametric statistical analysis: Mann Whitney U Test for independent samples||Null hypothesis: There will not be a difference in improvement in walking under dual-task conditions following cognitive training that incorporates speed of processing tasks compared to general cognitive training.||||0.414
71071162|NCT01895608|141651113|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.181|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in walking under dual-task conditions following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.||||0.181
71071163|NCT01895608|141651113|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||1|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in walking under dual-task conditions following cognitive training that incorporates speed of processing tasks compared to general cognitive training.||||1.000
71071164|NCT01895608|141651114|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||1|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in fall risk as measured by dynamic gait index following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.||||1.000
71114016|NCT03645421|141735462|OTHER||LS mean difference|-0.053|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|-0.077|-0.03|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 200 mcg - Placebo|Pair-wise comparison of MEDI0382 200 mcg versus Placebo.||-0.030|-0.077|<0.0001
71114017|NCT03645421|141735462|OTHER||LS mean difference|-0.049|STANDARD_ERROR_OF_MEAN|0.012||0.0002|TWO_SIDED|95.0|-0.074|-0.024|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 300 mcg - Placebo|Pair-wise comparison of MEDI0382 300 mcg versus Placebo.||-0.024|-0.074|0.0002
70939316|NCT03345407|141379320|OTHER||Posterior adjusted median difference|-2.9|||||TWO_SIDED|95.0|-6.2|1.1|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.1|-6.2|
71071165|NCT01895608|141651114|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.662|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in fall risk as measured by dynamic gait index following cognitive training that incorporates speed of processing tasks compared to general cognitive training.||||0.662
71114018|NCT02253433|141735474|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.575|TWO_SIDED|95.0|-0.87|2.07|||Mixed Models Analysis|||||2.07|-.87|0.575
70939317|NCT03345407|141379320|OTHER||Posterior adjusted median difference|-3.2|||||TWO_SIDED|95.0|-6.7|0.4|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||0.4|-6.7|
70939318|NCT03345407|141379320|OTHER||Posterior adjusted median difference|-0.1|||||TWO_SIDED|95.0|-4.0|3.5|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||3.5|-4.0|
70939319|NCT03345407|141379320|OTHER||Posterior adjusted median difference|-0.2|||||TWO_SIDED|95.0|-2.7|2.3|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.3|-2.7|
70939320|NCT03345407|141379320|OTHER||Posterior adjusted median difference|4.1|||||TWO_SIDED|95.0|-2.5|11.0|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||11.0|-2.5|
71071166|NCT01895608|141651115|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in static balance as measured by sensory organization test following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.||||0.05
71114019|NCT02253433|141735475|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.141|TWO_SIDED|95.0|-0.18|0.68|||Mixed Models Analysis|||||.68|-.18|0.141
71114020|NCT02253433|141735476|SUPERIORITY||Odds Ratio (OR)|0.86||||0.043|TWO_SIDED|95.0|0.47|1.57|||Mixed Models Analysis|ED visits over the previous 12 months were positively skewed (skewness 2.95; kurtosis 14.1); the responses were dichotomized (0 vs. 1 or more).||||1.57|.47|0.043
71071167|NCT01895608|141651115|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.171|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in static balance as measured by sensory organization test following cognitive training that incorporates speed of processing tasks compared to general cognitive training.||||0.171
71071168|NCT01895608|141651116|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.313|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in gait speed following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.||||0.313
71071169|NCT01895608|141651116|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.852|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in gait speed following cognitive training that incorporates speed of processing tasks compared to general cognitive training.||||0.852
71071170|NCT01895608|141651117|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.263|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in balance confidence following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.||||0.263
71071171|NCT01895608|141651117|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.181|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in balance confidence following cognitive training that incorporates speed of processing tasks compared to general cognitive training.||||0.181
71071172|NCT02275780|141651128|NON_INFERIORITY|Doravirine is concluded to be non-inferior to darunavir + ritonavir if the lower bound of the 95% CI for the difference in percent response is above -10 percentage points.|Treatment Difference|3.913|||||TWO_SIDED|95.0|-1.59|9.415|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||9.415|-1.590|
71071173|NCT02275780|141651129|NON_INFERIORITY|Doravirine is concluded to be non-inferior to darunavir + ritonavir if the lower bound of the 95% CI for the difference in percent response is above -10 percentage points.|Treatment Difference|7.082|||||TWO_SIDED|95.0|0.508|13.656|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||13.656|0.508|
71071174|NCT02275780|141651130|OTHER||Mean treatment difference|7.1|||||TWO_SIDED|95.0|-20.8|35.0|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||35.0|-20.8|
71071175|NCT02275780|141651131|OTHER||Mean treatment difference|17.4|||||TWO_SIDED|95.0|-14.5|49.3|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||49.3|-14.5|
71114021|NCT03636893|141735510|OTHER|Two-sided log-rank test comparing disease-free survival between treatment groups. No adjustment for multiple comparisons as this was a pre-specified secondary endpoint. Statistical significance set at P \<0.05.|Hazard Ratio (HR)|1.06||||0.842|TWO_SIDED|95.0|0.597|1.884||P-value from two-sided log-rank test. Alpha level set at 0.05.|Log Rank|Kaplan-Meier survival analysis with log-rank test for between-group comparison. Analysis performed using SPSS version 30.0.|Hazard ratio from Cox proportional hazards regression with FLOT as reference group.|Disease-free survival analysis in intention-to-treat population. DFS defined as time from randomization to first occurrence of local recurrence, regional recurrence, distant metastases, or death from any cause.|Kaplan-Meier method used to estimate DFS curves. Cox regression performed to calculate hazard ratios.|1.884|0.597|0.842
71114022|NCT03636893|141735511|OTHER|Two-sided log-rank test comparing overall survival between treatment groups. No adjustment for multiple comparisons as this was a pre-specified secondary endpoint. Statistical significance set at P \<0.05.|Hazard Ratio (HR)|1.101||||0.759|TWO_SIDED|95.0|0.595|2.036||P-value from two-sided log-rank test. No adjustment for multiple comparisons as overall survival was a pre-specified secondary endpoint. Alpha level set at 0.05.|Log Rank|Kaplan-Meier survival analysis with log-rank test for between-group comparison. Analysis performed using SPSS version 30.0.|Hazard ratio from Cox proportional hazards regression with FLOT as reference group.|Primary survival analysis comparing overall survival between neoadjuvant FLOT and SOX regimens in intention-to-treat population.|Kaplan-Meier method used to estimate survival curves. Cox regression performed to calculate hazard ratios. Multivariable analysis performed to identify independent predictors.|2.036|0.595|0.759
71071176|NCT02275780|141651132|OTHER||Treatment Difference (mg/dL)|-14.61|||<|0.0001|TWO_SIDED|95.0|-18.15|-11.06|||ANCOVA|Terms for Baseline lipid level and treatment group||||-11.06|-18.15|<0.0001
71071177|NCT02275780|141651133|OTHER||Treatment Difference (mg/dL)|-19.34|||<|0.0001|TWO_SIDED|95.0|-23.33|-15.35|||ANCOVA|Terms for Baseline lipid level and treatment group||||-15.35|-23.33|<0.0001
71071178|NCT02275780|141651142|OTHER||Treatment Difference|4.169|||||TWO_SIDED|95.0|-1.404|9.743|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||9.743|-1.404|
71071179|NCT02275780|141651143|OTHER||Treatment Difference|7.606|||||TWO_SIDED|95.0|0.98|14.232|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||14.232|0.980|
71071180|NCT03960866|141651144|SUPERIORITY||Mean Difference (Net)|0.12||||0.89|TWO_SIDED||||||t-test, 2 sided|||||||0.89
70852893|NCT03745820|141194620|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|1.161|=|0.7132|TWO_SIDED|95.0|-2.72|1.87||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Speed of Processing: Change From Baseline at Week 12||1.87|-2.72|=0.7132
70939321|NCT03345407|141379320|OTHER||Posterior adjusted median difference|-1.2|||||TWO_SIDED|95.0|-4.8|2.5|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.5|-4.8|
70852894|NCT03745820|141194620|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|1.203|=|0.9428|TWO_SIDED|95.0|-2.46|2.29||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Attention/Vigilance: Change From Baseline at Week 12||2.29|-2.46|=0.9428
70939322|NCT03345407|141379320|OTHER||Posterior adjusted median difference|-2.7|||||TWO_SIDED|95.0|-6.3|1.1|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.1|-6.3|
70939323|NCT03345407|141379320|OTHER||Posterior adjusted median difference|-3.3|||||TWO_SIDED|95.0|-7.3|0.4|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||0.4|-7.3|
71071181|NCT05129475|141651161|OTHER||Ratio of Adjusted Geometric Means|120.9|||||TWO_SIDED|90.0|109.3|133.74|||||Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|||133.74|109.30|
71071182|NCT05129475|141651162|OTHER||Ratio of Adjusted Geometric Means|119.67|||||TWO_SIDED|90.0|108.75|131.68|||||Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|||131.68|108.75|
71071183|NCT05129475|141651163|OTHER||Ratio of Adjusted Geometric Means|161.01|||||TWO_SIDED|90.0|139.05|186.44|||||Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|||186.44|139.05|
71071184|NCT01044290|141651185|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|||<|0.61|TWO_SIDED|95.0|-1.1|0.7|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks||.7|-1.1|<0.61
71071185|NCT01044290|141651185|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|||<|0.02|TWO_SIDED|95.0|0.2|2.0|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks.||2.0|.2|<.02
70939324|NCT03345407|141379320|OTHER||Posterior adjusted median difference|-0.8|||||TWO_SIDED|95.0|-4.6|3.0|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||3.0|-4.6|
70939325|NCT03345407|141379320|OTHER||Posterior adjusted median difference|-0.4|||||TWO_SIDED|95.0|-2.9|2.5|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.5|-2.9|
70939326|NCT03345407|141379320|OTHER||Posterior adjusted median difference|2.4|||||TWO_SIDED|95.0|-4.8|9.4|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||9.4|-4.8|
71114023|NCT02277691|141735538|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in office trough SBP at Week 12 (LOCF).||||<0.0001
70939327|NCT03345407|141379320|OTHER||Posterior adjusted median difference|-0.2|||||TWO_SIDED|95.0|-4.1|3.6|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||3.6|-4.1|
70939328|NCT03345407|141379320|OTHER||Posterior adjusted median difference|-2.3|||||TWO_SIDED|95.0|-6.1|1.8|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.8|-6.1|
70939329|NCT03345407|141379320|OTHER||Posterior adjusted median difference|-1.8|||||TWO_SIDED|95.0|-5.7|2.3|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.3|-5.7|
70939330|NCT03345407|141379320|OTHER||Posterior adjusted median difference|-0.3|||||TWO_SIDED|95.0|-4.5|3.8|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||3.8|-4.5|
71071186|NCT01044290|141651186|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|||=|0.9|TWO_SIDED|95.0|-1.2|1.1|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks||1.1|-1.2|=.9
70939331|NCT03345407|141379320|OTHER||Posterior adjusted median difference|1.2|||||TWO_SIDED|95.0|-1.7|4.0|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||4.0|-1.7|
70939332|NCT00065611|141379335|SUPERIORITY_OR_OTHER|||||||0.9074||95.0|||||Chi-squared|||||||0.9074
70939333|NCT00065611|141379336|SUPERIORITY_OR_OTHER|||||||0.4566||95.0|||||ANOVA|||||||0.4566
71071187|NCT01044290|141651186|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02|||<|0.97|TWO_SIDED|95.0|-1.2|1.1|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable||Comparison at 5 weeks.||1.1|-1.2|<.97
71071188|NCT01044290|141651187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|||<|0.91|TWO_SIDED|95.0|-1.4|1.5|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable||Comparison at 5 weeks||1.5|-1.4|<.91
70939334|NCT00065611|141379337|SUPERIORITY_OR_OTHER|||||||0.3792||95.0|||||ANOVA|||||||0.3792
70939335|NCT01951105|141379368|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
70939336|NCT02604199|141379374|SUPERIORITY||LS Mean Difference|-0.086|STANDARD_ERROR_OF_MEAN|0.048||0.081|TWO_SIDED|95.0|-0.183|0.011||Mixed effect model repeat measurement (MMRM) includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit.|MMRM|Within-subject covariance is unstructured.||||0.011|-0.183|0.0810
70939337|NCT02604199|141379374|SUPERIORITY||LS Mean Difference|-0.309|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001|TWO_SIDED|95.0|-0.406|-0.212||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||||-0.212|-0.406|<.0001
70939338|NCT02604199|141379374|SUPERIORITY||LS Mean Difference|-0.223|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001|TWO_SIDED|95.0|-0.322|-0.124||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||||-0.124|-0.322|<.0001
71114024|NCT02277691|141735538|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in office trough SBP at Week 52 (LOCF).||||<0.0001
70939339|NCT02604199|141379375|SUPERIORITY||LS Mean|-0.089|STANDARD_ERROR_OF_MEAN|0.046||0.0583|TWO_SIDED|95.0|-0.181|0.003||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 15||0.003|-0.181|0.0583
71071189|NCT01044290|141651187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|||=|0.42|TWO_SIDED|95.0|-2.1|0.9|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable||Comparison at 5 weeks||0.9|-2.1|=.42
71071190|NCT01044290|141651188|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|||=|0.58|TWO_SIDED|95.0|-1.5|2.8|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks||2.8|-1.5|=.58
71071191|NCT01044290|141651188|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04|||<|0.97|TWO_SIDED|95.0|-2.1|2.2|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks.||2.2|-2.1|<.97
71114025|NCT02277691|141735538|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in office trough sitting DBP at Week 12 (LOCF).||||<0.0001
71114026|NCT02277691|141735538|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in office trough sitting DBP at Week 52 (LOCF).||||<0.0001
70939340|NCT02604199|141379375|SUPERIORITY||LS Mean|-0.176|STANDARD_ERROR_OF_MEAN|0.045||0.003|TWO_SIDED|95.0|-0.267|-0.085||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 15||-0.085|-0.267|0.003
70939341|NCT02604199|141379375|SUPERIORITY||LS Mean|-0.087|STANDARD_ERROR_OF_MEAN|0.047||0.067|TWO_SIDED|95.0|-0.181|0.006||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 15||0.006|-0.181|0.0670
70939342|NCT02604199|141379375|SUPERIORITY||LS Mean|-0.07|STANDARD_ERROR_OF_MEAN|0.04||0.0875|TWO_SIDED|95.0|-0.151|0.011||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 29||0.011|-0.151|0.0875
70939343|NCT02604199|141379375|SUPERIORITY||LS Mean|-0.179|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.259|-0.1||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 29||-0.100|-0.259|<.0001
71071192|NCT01044290|141651189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.25|TWO_SIDED|95.0|-0.6|2.4|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks||2.4|-.6|.25
71071193|NCT01044290|141651189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|||<|0.05|TWO_SIDED|95.0|0.05|3.1|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks||3.1|.05|<.05
71071194|NCT01044290|141651190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|||<|0.57|TWO_SIDED|95.0|-1.0|1.8|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable. Sex item omitted from scale.||Comparison at 5 weeks.||1.8|-1.0|<.57
71071195|NCT01044290|141651190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4|||=|0.055|TWO_SIDED|95.0|-0.03|2.7|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable. Sex item omitted from scale.||Comparison at 5 weeks.||2.7|-0.03|=0.055
71071196|NCT01646021|141651201|OTHER||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.35|0.6|||Log Rank|||||0.60|0.35|< 0.0001
71071197|NCT01646021|141651203|SUPERIORITY||Hazard Ratio (HR)|0.74|||=|0.0621|TWO_SIDED|95.0|0.54|1.02|||Log Rank|||||1.02|0.54|= 0.0621
71071198|NCT01663779|141651276|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0|||<|0.01|TWO_SIDED|95.0|3.0|7.0|||Chi-squared|||||7|3|<0.01
71114027|NCT02277691|141735539|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in home SBP, morning at End of Week 12.||||<0.0001
70939344|NCT02604199|141379375|SUPERIORITY||LS Mean|-0.109|STANDARD_ERROR_OF_MEAN|0.041||0.0099|TWO_SIDED|95.0|-0.191|-0.027||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 29||-0.027|-0.191|0.0099
71071199|NCT01967706|141651286|OTHER||Geometric LS Mean Ratio|88.47|||||TWO_SIDED|95.0|68.64|114.03|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (mTHS - Group 1:mCC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of mTHS:mCC) for Cmax, therefore, there was no statistical hypothesis to be tested for this objective.||114.03|68.64|
71071200|NCT01967706|141651287|OTHER||Geometric LS Mean Ratio|98.13|||||TWO_SIDED|95.0|80.61|119.46|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (mTHS - Group 1:mCC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of mTHS:mCC) for AUC(0-last), therefore, there was no statistical hypothesis to be tested for this objective.||119.46|80.61|
71071201|NCT02347891|141651311|SUPERIORITY||Risk Ratio (RR)|0.5||||0.6|TWO_SIDED|95.0|0.08|2.65|||ANOVA|||Definition of Improvement (DOI) at week 40||2.65|0.08|0.60
71114028|NCT02277691|141735539|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in home SBP, morning at EOT (Up to Week 52).||||<0.0001
71114029|NCT02277691|141735539|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in home DBP, morning at End of Week 12.||||<0.0001
71114030|NCT02277691|141735539|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in home DBP, morning at EOT (Up to Week 52).||||<0.0001
71071202|NCT02347891|141651311|SUPERIORITY||Risk Ratio (RR)|0.6||||0.61|TWO_SIDED|95.0|0.16|1.82|||ANOVA|||Percent patients reaching Total improvement score of ≥40 at Week 40||1.82|0.16|0.61
71071203|NCT02347891|141651311|SUPERIORITY||Risk Ratio (RR)|0.0||||0.23|TWO_SIDED|95.0|0.0|1.47|||ANOVA|||Percent of patient with major improvement TIS ≥60 at Week 40||1.47|0|0.23
71071204|NCT02347891|141651312|SUPERIORITY|||||||0.92|||||||ANOVA|||Mean Total Improvement Score (TIS) during Randomized Phase at Week 40||||0.92
71071205|NCT02347891|141651313|SUPERIORITY||Risk Ratio (RR)|0.0||||0.23|TWO_SIDED|95.0|0.0|1.47|||ANOVA|||Definition of Improvement (DOI) at Week 64||1.47|0|0.23
71071206|NCT02347891|141651313|SUPERIORITY||Risk Ratio (RR)|0.75||||0.99|TWO_SIDED|95.0|0.19|2.51|||ANOVA|||Percent patients reaching Total improvement score of ≥40 at Week 64||2.51|0.19|0.99
71071207|NCT02347891|141651313|SUPERIORITY||Risk Ratio (RR)|0.0||||0.23|TWO_SIDED|95.0|0.0|1.47|||ANOVA|||Percent of patient with major improvement TIS ≥60 at Week 64||1.47|0|0.23
71071208|NCT02347891|141651314|SUPERIORITY|||||||0.62|||||||ANOVA|||Mean Total Improvement Score (TIS) after Open Label Phase at 64 Week||||0.62
71071209|NCT05845567|141651315|SUPERIORITY||ratio of the Geometric LSmeans|139.43|||||TWO_SIDED|90.0|129.73|149.86||||||||149.86|129.73|
71114031|NCT03818607|141735540|NON_INFERIORITY|The clinical similarity of the Week 27 LDH between treatments was assessed by comparing the 1-sided 97.5% upper confidence interval (CI) limit for the geometric mean ratio of LDH at Week 27 between ABP 959 treatment and eculizumab treatment with a non-inferiority margin of 2.873.|Geometric LS mean ratio (GMR)|1.0628|||||ONE_SIDED|97.5||1.1576||||||||1.1576||
71114032|NCT03818607|141735541|OTHER|The clinical similarity of the AUEC between treatments was assessed by comparing 2-sided 90% CI for the GMR of the time-adjusted AUEC of LDH (Week 13 to Week 27, Week 39 to Week 53, and Week 65 to Week 79) between ABP 959 treatment and eculizumab treatment with a similarity margin of (0.77, 1.30).|GMR|0.9812|||||TWO_SIDED|90.0|0.9403|1.0239||||||||1.0239|0.9403|
71114033|NCT03818607|141735549|OTHER||GMR|1.0314|||||ONE_SIDED|97.5||1.1201||||||||1.1201||
71114034|NCT03818607|141735552|OTHER||GMR|0.9122|||||TWO_SIDED|90.0|0.7586|1.0968||||||Total PK AUC GMR (ABP 959/Eculizumab)||1.0968|0.7586|
71114035|NCT03818607|141735552|OTHER||GMR|0.9508|||||TWO_SIDED|90.0|0.7454|1.213||||||Unbound PK AUC GMR (ABP 959/Eculizumab)||1.2130|0.7454|
71114036|NCT05059301|141735559|EQUIVALENCE|Clinical equivalence is demonstrated if the 2 sided 95% confidence interval (CI) of the GMC ratios (RSV OA\_Lot 1 divided by RSV OA\_Lot 2) is within the pre defined limit of \[0.67, 1.5\].|Adjusted group GMC ratio|1.06|||||TWO_SIDED|95.0|0.94|1.21||||||To demonstrate the clinical equivalence of RSV OA\_Lot 1 versus RSV OA\_Lot 2 in terms of RSV PreF3 IgG concentrations expressed as group GMC ratio at one month post vaccination. The 2-sided 95% CI for group GMC ratio was derived from an ANCOVA model on log10 transformed RSV PreF3 IgG antibody titers. The ANCOVA model included the treatment group and the age category (age at vaccination: 60-69, 70-79 or \>=80 years) and the center as fixed effects and the pre-dose log10 titer as covariate.||1.21|0.94|
71114037|NCT05059301|141735559|EQUIVALENCE|Clinical equivalence is demonstrated if the 2 sided 95% CI of the GMC ratios (RSV OA\_Lot 1 divided by RSV OA\_Lot 3) is within the pre defined limit of \[0.67, 1.5\].|Adjusted group GMC ratio|0.92|||||TWO_SIDED|95.0|0.81|1.04||||||To demonstrate the clinical equivalence of RSV OA\_Lot 1 versus RSV OA\_Lot 3 in terms of RSV PreF3 IgG concentrations expressed as group GMC ratio at one month post vaccination. The 2-sided 95% CI for group GMC ratio was derived from an ANCOVA model on log10 transformed RSV PreF3 IgG antibody titers. The ANCOVA model included the treatment group and the age category (age at vaccination: 60-69, 70-79 or \>=80 years) and the center as fixed effects and the pre-dose log10 titer as covariate.||1.04|0.81|
71114038|NCT05059301|141735559|EQUIVALENCE|Clinical equivalence is demonstrated if the 2 sided 95% CI of the GMC ratios (RSV OA\_Lot 2 divided by RSV OA\_Lot 3) is within the pre defined limit of \[0.67, 1.5\].|Adjusted group GMC ratio|0.87|||||TWO_SIDED|95.0|0.77|0.99||||||To demonstrate the clinical equivalence of RSV OA\_Lot 2 versus RSV OA\_Lot 3 in terms of RSV PreF3 IgG concentrations expressed as group GMC ratio at one month post vaccination. The 2-sided 95% CI for group GMC ratio was derived from an ANCOVA model on log10 transformed RSV PreF3 IgG antibody titers. The ANCOVA model included the treatment group and the age category (age at vaccination: 60-69, 70-79 or \>=80 years) and the center as fixed effects and the pre-dose log10 titer as covariate.||0.99|0.77|
71114039|NCT04004221|141735625|OTHER||||||<|0.0001|||||||Exact Binomial Test|1-sided p-value was based on binomial exact test of Tislelizumab versus historical rate of 0.1||||||< 0.0001
70939345|NCT02604199|141379375|SUPERIORITY||LS Mean|-0.143|STANDARD_ERROR_OF_MEAN|0.043||0.0017|TWO_SIDED|95.0|-0.229|-0.057||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 43||-0.057|-0.229|0.0017
71114040|NCT01153711|141735635|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|168.4|STANDARD_DEVIATION|16.4||1|TWO_SIDED|90.0|155.5|182.4||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol||182.4|155.5|1.0000
71114041|NCT01153711|141735636|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|166.1|STANDARD_DEVIATION|16.8||1|TWO_SIDED|90.0|153.6|179.6||P-value for ratio outside 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol for the category Olodaterol||179.6|153.6|1.0000
71114042|NCT01153711|141735636|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|106.63|STANDARD_DEVIATION|14.7||0.0001|TWO_SIDED|90.0|100.211|113.463||P-value for ratio outside 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol for the category Olodaterol glucuronide||113.463|100.211|0.0001
71114043|NCT01153711|141735639|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|144.23|STANDARD_DEVIATION|17.8||0.9986|TWO_SIDED|90.0|133.853|155.417||P-value for ratio outside 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol for the category Olodaterol||155.417|133.853|0.9986
71114044|NCT01153711|141735639|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|132.87|STANDARD_DEVIATION|18.9||0.8991|TWO_SIDED|90.0|122.732|143.843||P-value for ratio outside 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol for the category Olodaterol glucuronide||143.843|122.732|0.8991
71114045|NCT01153711|141735640|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|100.75|STANDARD_DEVIATION|17.9||0.0001|TWO_SIDED|90.0|92.534|109.692||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol||109.692|92.534|0.0001
71114046|NCT01178944|141735652|OTHER||Mean Difference (Final Values)|1.08||||0.585|TWO_SIDED|95.0|0.78|1.38|||t-test, 2 sided|||Comparison is CR+PR vs stable disease/progression||1.38|0.78|0.585
71114047|NCT01939977|141735653|SUPERIORITY|||||||0.0083|||||||Chi-squared|||"Taking per protocol population, the percentage of patients with iPTH\> 110 pg / ml at 6 months post-transplant treated with Paricalcitol was statistically lower than in patients treated with Calcifediol"||||0.0083
71071210|NCT05845567|141651316|SUPERIORITY||ratio of the Geometric LSmeans|117.97|||||TWO_SIDED|90.0|112.24|124.0||||||||124.00|112.24|
71071211|NCT05845567|141651317|SUPERIORITY||ratio of the Geometric LSmeans|117.88|||||TWO_SIDED|90.0|112.13|123.92||||||||123.92|112.13|
71071212|NCT03409107|141651333|SUPERIORITY||LS Mean Difference|1.4|||<|0.0001|TWO_SIDED|95.0|1.23|1.56|||ANCOVA|One-sided p-value based on test of null hypothesis: (Daprodustat - Placebo) \<= 0 versus alternative: difference \> 0.|Treatment group comparisons were based on a ANCOVA model with terms for treatment, Baseline hemoglobin, and region.|||1.56|1.23|<0.0001
71071213|NCT03409107|141651334|SUPERIORITY||Difference in Response rate|0.56|||<|0.0001|TWO_SIDED|95.0|0.49|0.63||One-sided p-value was based on test of null hypothesis: (Daprodustat - Placebo) \<=0 versus alternative: difference \> 0|Cochran-Mantel-Haenszel||Treatment group comparisons were based on a Cochran-Mantel-Haenszel test adjusted for treatment group and region.|||0.63|0.49|<0.0001
71071214|NCT03409107|141651335|SUPERIORITY||LS Mean Difference|5.36||||0.0005|TWO_SIDED|95.0|2.17|8.56||One-sided p-value based on test of null hypothesis:(Daprodustat-Placebo) \<= 0 vs alternative: difference \> 0.|ANCOVA||Treatment group comparisons were based on ANCOVA model with terms for treatment, Baseline score, and region.|||8.56|2.17|0.0005
71114048|NCT03206918|141735715|SUPERIORITY||2-side Clopper-Pearson|87.9|||<|0.0001|TWO_SIDED|95.0|79.4|93.81|||Exact Binomial Test|The null hypothesis is ORR = 32%||||93.81|79.40|<0.0001
71114049|NCT03823287|141735721|NON_INFERIORITY|If the lower bound of a two-sided 95.03% confidence interval (CI) for the difference in adjusted means of the two treatments (faricimab minus aflibercept) is greater than -4 letters (the non-inferiority margin), then faricimab is considered non-inferior to aflibercept.|Adjusted mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|-1.1|2.5|||||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|The null hypothesis, H0: μ(faricimab) - μ(aflibercept) ≤-4 letters; the alternative hypothesis, Ha: μ(faricimab) - μ(aflibercept) \>-4 letters. A sample size of approximately 320 participants in each arm provided greater than 90% power to show non-inferiority of faricimab to aflibercept in the change from baseline BCVA averaged over Weeks 40, 44, and 48 in the ITT population, using a non-inferiority margin of 4 letters at the one-sided 0.02485 significance level.||2.5|-1.1|
71114050|NCT03823287|141735722|OTHER||Adjusted mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-1.2|2.7|||||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|Treatment Difference in Adjusted Means at Weeks 52-60||2.7|-1.2|
71114051|NCT03823287|141735724|OTHER||Difference in CMH Weighted Percentage|4.3|||||TWO_SIDED|95.0|-1.6|10.1|||||The treatment difference in CMH weighted percentage of participants gaining ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥15 Letters: Treatment Difference at Weeks 40-48||10.1|-1.6|
71114052|NCT03823287|141735724|OTHER||Difference in CMH Weighted Percentage|5.4|||||TWO_SIDED|95.0|-2.0|12.7|||||The treatment difference in CMH weighted percentage of participants gaining ≥10 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥10 Letters: Treatment Difference at Weeks 40-48||12.7|-2.0|
71114053|NCT03823287|141735724|OTHER||Difference in CMH Weighted Percentage|1.2|||||TWO_SIDED|95.0|-6.6|8.9|||||The treatment difference in CMH weighted percentage of participants gaining ≥5 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥5 Letters: Treatment Difference at Weeks 40-48||8.9|-6.6|
71071215|NCT03409107|141651336|SUPERIORITY||Difference in Response rate|0.45|||<|0.0001|TWO_SIDED|95.0|0.37|0.52||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|Cochran-Mantel-Haenszel||Treatment group comparisons are based on a Cochran-Mantel-Haenszel test adjusted for treatment group, and region|||0.52|0.37|<0.0001
71114054|NCT03823287|141735724|OTHER||Difference in CMH Weighted Percentage|-1.2|||||TWO_SIDED|95.0|-7.9|5.4|||||The treatment difference in CMH weighted percentage of participants gaining ≥0 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥0 Letters: Treatment Difference at Weeks 40-48||5.4|-7.9|
71114055|NCT03823287|141735725|OTHER||Difference in CMH Weighted Percentage|2.7|||||TWO_SIDED|95.0|-3.2|8.5|||||The treatment difference in CMH weighted percentage of participants gaining ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 52-60||8.5|-3.2|
71114056|NCT03823287|141735730|OTHER||Difference in CMH Weighted Percentage|1.3|||||TWO_SIDED|95.0|-2.2|4.8|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Avoiding a Loss of ≥15 Letters: Treatment Difference at Weeks 40-48||4.8|-2.2|
70941955|NCT00714688|141384217|SUPERIORITY_OR_OTHER|||||||0.052||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|The ANCOVA model has been performed on ranked data. Treatment, gender and country were used as factors and age was used as a covariate.||||||0.052
71071216|NCT03409107|141651337|SUPERIORITY||Difference in treatment effect|38.8|||||TWO_SIDED|95.0|25.0|54.55|||Hodges-Lehmann Estimate|Hodges-Lehmann Estimate of treatment difference has been reported.||||54.55|25.00|
71071217|NCT03409107|141651338|SUPERIORITY||Difference in treatment effect|0.768|||<|0.0001|TWO_SIDED|95.0|0.729|0.806||One-sided superiority p-value from the van Elteren test|van Elteren test||Mann-Whitney estimate of the treatment difference stratified by region has been presented.|||0.806|0.729|<0.0001
71071218|NCT03409107|141651339|SUPERIORITY||LS Mean difference|1.36|||<|0.0001|TWO_SIDED|95.0|1.16|1.55||One-sided superiority p-value from the MMRM model|MMRM||Treatment group comparisons were based on MMRM fitted from Baseline up to Week 28, with factors for treatment, time, region, Baseline Hb and Baseline Hb by time and treatment by time interactions.|||1.55|1.16|<0.0001
71071219|NCT03409107|141651340|SUPERIORITY||Hazard Ratio (HR)|0.07||||0.0002|TWO_SIDED|95.0|0.02|0.3||One-sided p-value was based on Wald test of null hypothesis: (Daprodustat/Placebo) \>=1 versus alternative: ratio\<1.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model adjusted for treatment group and region.|||0.30|0.02|0.0002
71071220|NCT03409107|141651341|SUPERIORITY||Mean Difference (Net)|5.91|||<|0.0001|TWO_SIDED|95.0|2.83|9.0||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Tired/Low Energy/Weak domain.|||9.00|2.83|<0.0001
71071221|NCT03409107|141651341|SUPERIORITY||Mean Difference (Net)|2.93||||0.0152|TWO_SIDED|95.0|0.28|5.57||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Chest Pain/Shortness of Breath Domain.|||5.57|0.28|0.0152
71071222|NCT03409107|141651341|SUPERIORITY||Mean Difference (Net)|3.79||||0.0045|TWO_SIDED|95.0|0.95|6.63||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Cognitive Domain.|||6.63|0.95|0.0045
71071223|NCT03409107|141651341|SUPERIORITY||Mean Difference (Net)|2.61||||0.1267|TWO_SIDED|95.0|-1.87|7.09||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Difficulty Sleeping|||7.09|-1.87|0.1267
71071224|NCT03409107|141651341|SUPERIORITY||Mean Difference (Net)|4.64||||0.0203|TWO_SIDED|95.0|0.2|9.09||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Difficulty Standing for Long Periods of Time|||9.09|0.20|0.0203
71071225|NCT03409107|141651341|SUPERIORITY||Mean Difference (Net)|2.68||||0.0266|TWO_SIDED|95.0|-0.04|5.39||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Severity of Shortness of Breath While Sitting or Resting|||5.39|-0.04|0.0266
71071226|NCT03409107|141651341|SUPERIORITY||Mean Difference (Net)|2.01||||0.0907|TWO_SIDED|95.0|-0.94|4.96||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Time with Shortness of Breath While not Doing an Activity|||4.96|-0.94|0.0907
71071227|NCT03409107|141651342|SUPERIORITY||Mean Difference (Net)|-0.13||||0.0391|TWO_SIDED|95.0|-0.28|0.02||One-sided p-value was based on test of null hypothesis: (Daprodustat-rhEPO) \>=0 versus alternative: difference \<0|MMRM||MMRM fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.02|-0.28|0.0391
71071228|NCT03409107|141651343|SUPERIORITY||Mean Difference (Net)|2.57||||0.0858|TWO_SIDED|95.0|-1.12|6.26||One sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 vs. alternative: difference \>0.|MMRM||MMRM fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions.|||6.26|-1.12|0.0858
71071229|NCT03409107|141651344|SUPERIORITY||Mean Difference (Net)|0.17||||0.0357|TWO_SIDED|95.0|-0.02|0.36||One sided p-value based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||MMRM fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Did you feel full of life?.|||0.36|-0.02|0.0357
71071230|NCT03409107|141651344|SUPERIORITY||Mean Difference (Net)|0.17||||0.0328|TWO_SIDED|95.0|-0.01|0.35||One-sided p-value based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||MMRM fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Did you have a lot of energy?.|||0.35|-0.01|0.0328
71071231|NCT03409107|141651344|SUPERIORITY||Mean Difference (Net)|0.18||||0.0252|TWO_SIDED|95.0|0.0|0.37||One-sided p-value based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||MMRM fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Did you feel worn out?.|||0.37|0.00|0.0252
71071232|NCT03409107|141651344|SUPERIORITY||Mean Difference (Net)|0.26||||0.001|TWO_SIDED|95.0|0.1|0.42||One-sided p-value based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||MMRM fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Did you feel tired?.|||0.42|0.10|0.0010
71071233|NCT03409107|141651351|SUPERIORITY||Mean Difference (Net)|0.03||||0.1098|TWO_SIDED|95.0|-0.02|0.07||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus. alternative: difference \>0.|MMRM||Based on MMRM model fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.07|-0.02|0.1098
71071234|NCT03409107|141651352|SUPERIORITY||Mean Difference (Net)|4.5||||0.012|TWO_SIDED|95.0|0.6|8.4||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 vs. alternative: difference \>0.|MMRM||MMRM model fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions.|||8.40|0.60|0.0120
71114057|NCT03823287|141735730|OTHER||Difference in CMH Weighted Percentage|-0.4|||||TWO_SIDED|95.0|-4.6|3.9|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥10 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Avoiding a Loss of ≥10 Letters: Treatment Difference at Weeks 40-48||3.9|-4.6|
71071235|NCT03409107|141651353|SUPERIORITY||Mean Difference (Net)|0.4||||0.6106|TWO_SIDED|95.0|-2.42|3.22||"One-sided p-value was based on test of null hypothesis: (Daprodustat - Placebo) \>= 0 versus alternative:~difference \<0"|MMRM||MMRM model fitted from Baseline up to Week 28, with factors for treatment, time, region, Baseline SBP and Baseline SBP by time and treatment by time interactions.|||3.22|-2.42|0.6106
71071236|NCT03409107|141651353|SUPERIORITY||Mean Difference (Net)|1.8||||0.9819|TWO_SIDED|95.0|0.12|3.49||"One-sided p-value was based on test of null hypothesis: (Daprodustat - Placebo) \>= 0 versus alternative:~difference \< 0"|MMRM||MMRM model fitted from Baseline up to Week 28, with factors for treatment, time, region, Baseline DBP and Baseline DBP by time and treatment by time interactions.|||3.49|0.12|0.9819
71114058|NCT03823287|141735730|OTHER||Difference in CMH Weighted Percentage|1.2|||||TWO_SIDED|95.0|-4.0|6.4|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥5 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Avoiding a Loss of ≥5 Letters: Treatment Difference at Weeks 40-48||6.4|-4.0|
71114059|NCT03823287|141735731|OTHER||Difference in CMH Weighted Percentage|-0.2|||||TWO_SIDED|95.0|-3.9|3.6|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 52-60||3.6|-3.9|
71114060|NCT03823287|141735735|OTHER||Difference in CMH Weighted Percentage|3.0|||||TWO_SIDED|95.0|-3.6|9.5|||||The treatment difference in CMH weighted percentage of participants gaining ≥15 letters or achieving BCVA ≥84 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 40-48||9.5|-3.6|
71114061|NCT03823287|141735737|OTHER||Difference in CMH Weighted Percentage|-0.5|||||TWO_SIDED|95.0|-7.7|6.6|||||The treatment difference in CMH weighted percentage of participants achieving BCVA ≥69 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 40-48||6.6|-7.7|
71114062|NCT03823287|141735739|OTHER||Difference in CMH Weighted Percentage|-0.5|||||TWO_SIDED|95.0|-4.2|3.3|||||The treatment difference in CMH weighted percentage of participants with BCVA ≤38 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 40-48||3.3|-4.2|
71114063|NCT03823287|141735747|OTHER||Adjusted mean difference|-7.4|STANDARD_ERROR_OF_MEAN|4.19|||TWO_SIDED|95.0|-15.7|0.8|||||The treatment difference in adjusted means of change from baseline CST is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|Treatment Difference in Adjusted Means at Weeks 40-48||0.8|-15.7|
71114064|NCT03823287|141735748|OTHER||Adjusted mean difference|1.0|STANDARD_ERROR_OF_MEAN|4.26|||TWO_SIDED|95.0|-7.4|9.4|||||The treatment difference in adjusted means of change from baseline CST is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|Treatment Difference in Adjusted Means at Weeks 52-60||9.4|-7.4|
71114065|NCT05926544|141735821|SUPERIORITY||Risk Ratio (RR)|0.46|||||TWO_SIDED|95.0|0.18|1.16|||||The Standard implementation arm was the reference group.|||1.16|0.18|
71114066|NCT01477710|141735822|SUPERIORITY_OR_OTHER_LEGACY||ANOVA F-value|266.39|||<|0.0001||||||This p-value is for the omnibus F-test of between-treatment differences in tidal volume|ANOVA|The p-value for the omnibus F-test was \<0.0001||Using ANOVA, pairwise comparisons of treatment means were made using a Tukey adjustment for multiple comparisons.||||<0.0001
71114067|NCT01477710|141735822|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|314.4|||<|0.0001||95.0|264.7|364.1|||t-test, 2 sided|||||364.1|264.7|<0.0001
71114068|NCT01477710|141735822|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|576.6|STANDARD_ERROR_OF_MEAN|25.0|<|0.0001|TWO_SIDED|95.0|526.9|626.3|||t-test, 2 sided|||||626.3|526.9|<0.0001
71114069|NCT01477710|141735822|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|262.2|STANDARD_DEVIATION|25.0|<|0.0001|TWO_SIDED|95.0|212.5|312.0|||t-test, 2 sided|||||312.0|212.5|<0.0001
71114070|NCT00335283|141736001|SUPERIORITY_OR_OTHER||Odds Ratio, log|3.12||||0.01|TWO_SIDED|95.0|1.28|7.59|||Regression, Logistic|||This applies to the 8 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||7.59|1.28|.01
71114071|NCT00335283|141736001|SUPERIORITY_OR_OTHER||Odds Ratio, log|3.5||||0.006|TWO_SIDED|95.0|1.41|8.67|||Regression, Logistic|||This applies to the 16 week treatment affect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||8.67|1.41|.006
71114072|NCT00335283|141736002|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.01||||0.97|TWO_SIDED|95.0|0.38|2.7|||Regression, Logistic|||This applies to the 8 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||2.70|0.38|.97
71114073|NCT00335283|141736002|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.11||||0.84|TWO_SIDED|95.0|0.4|3.06|||Regression, Logistic|||This applies to the 16 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||3.06|0.40|.84
71114074|NCT00335283|141736003|SUPERIORITY_OR_OTHER||Odds Ratio, log|2.44||||0.06|TWO_SIDED|95.0|0.95|6.31|||Regression, Logistic|||This applies to the 8 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||6.31|.95|.06
71114075|NCT00335283|141736003|SUPERIORITY_OR_OTHER||Odds Ratio, log|4.51||||0.007|TWO_SIDED|95.0|1.5|13.6|||Regression, Logistic|||This applies to the 16 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||13.6|1.5|.007
70852895|NCT03745820|141194620|SUPERIORITY||LS Mean Difference|0.93|STANDARD_ERROR_OF_MEAN|1.202|=|0.4425|TWO_SIDED|95.0|-1.45|3.3||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Attention/Vigilance: Change From Baseline at Week 12||3.30|-1.45|=0.4425
70939346|NCT02604199|141379375|SUPERIORITY||LS Mean|-0.265|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001|TWO_SIDED|95.0|-0.349|-0.18||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 43||-0.180|-0.349|<.0001
70939347|NCT02604199|141379375|SUPERIORITY||LS Mean|-0.122|STANDARD_ERROR_OF_MEAN|0.043||0.0072|TWO_SIDED|95.0|-0.209|-0.035||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 43||-0.035|-0.209|0.0072
70939348|NCT02604199|141379375|SUPERIORITY||LS Mean|-0.118|STANDARD_ERROR_OF_MEAN|0.039||0.0043|TWO_SIDED|95.0|-0.197|-0.039||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 57||-0.039|-0.197|0.0043
70939349|NCT02604199|141379375|SUPERIORITY||LS Mean|-0.298|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|-0.376|-0.221||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 57||-0.221|-0.376|< 0.0001
70939350|NCT02604199|141379375|SUPERIORITY||LS Mean|-0.181|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.261|-0.1||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 57||-0.100|-0.261|<.0001
70939351|NCT02604199|141379375|SUPERIORITY||LS Mean|-0.132|STANDARD_ERROR_OF_MEAN|0.048||0.0084|TWO_SIDED|95.0|-0.228|-0.035||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 71||-0.035|-0.228|0.0084
71071237|NCT03409107|141651353|SUPERIORITY||Mean Difference (Net)|1.31||||0.9215|TWO_SIDED|95.0|-0.51|3.13||"One-sided p-value was based on test of null hypothesis: (Daprodustat - Placebo) \>= 0 versus alternative:~difference \<0"|MMRM||MMRM model fitted from Baseline up to Week 28, with factors for treatment, time, region, Baseline MAP and Baseline MAP by time and treatment by time interactions.|||3.13|-0.51|0.9215
71071238|NCT03409107|141651354|SUPERIORITY||Difference in Response rate|0.06||||0.068|TWO_SIDED|95.0|-0.02|0.13||One-sided p-value based on test of null hypothesis: (Daprodustat - Placebo) \<= 0 versus alternative: difference \> 0.|Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel test was performed for treatment group comparison.|||0.13|-0.02|0.0680
71071239|NCT00715728|141651417|EQUIVALENCE|Our primary outcome was the rate of core rewarming during the surgery. Groups were compared on mean rewarming rate in a linear mixed effects regression model with within-subject change of core temperature over time as random effect. Using those model results, equivalence on the mean rate of rewarming for the resistive and warm air systems was assessed with the 2 one-tailed tests equivalence testing approach and equivalence delta of 0.2 degrees C/hours.||||||0.91||||||Two 1-tailed tests were conducted. P-value for lower delta was 0.91. Equivalence will be claimed if p-values for upper and lower delta are both lower than 0.05 ⁄ 2 = 0.025.|t-test, 1 sided|"Two 1-tailed tests were conducted to assess equivalence. See  Type of Statistical Test."||A total of 46 patients (23 per group) were needed to have 90% power to demonstrate equivalence of the two warming methods on final intra-operative temperature at the 0.05 significance level using the 2 one-tailed tests equivalence testing technique and an equivalence region of 0.5 degrees C per hour, assuming a SD of 0.5 degrees C/hour for each group and zero true difference.||||0.91
71071240|NCT00715728|141651417|EQUIVALENCE|Our primary outcome was the rate of core rewarming during the surgery. Groups were compared on mean rewarming rate in a linear mixed effects regression model with within-subject change of core temperature over time as random effect. Using those model results, equivalence on the mean rate of rewarming for the resistive and warm air systems was assessed with the 2 one-tailed tests equivalence testing approach and equivalence delta of 0.2 degrees C/hours.|||||<|0.001||||||Two 1-tailed tests were conducted. P-value for lower delta was 0.91. Equivalence will be claimed if p-values for upper and lower delta are both lower than 0.05 ⁄ 2 = 0.025.|t-test, 1 sided|||A total of 46 patients (23 per group) were needed to have 90% power to demonstrate equivalence of the two warming methods on final intra-operative temperature at the 0.05 significance level using the 2 one-tailed tests equivalence testing technique and an equivalence region of 0.5 degrees C per hour, assuming a SD of 0.5 degrees C/hour for each group and zero true difference.||||<0.001
71071241|NCT00715728|141651418|NON_INFERIORITY|The non-inferiority margin is defined as 0.5 °C. Non-inferiority at the 0.025 significance level will be claimed if the lower limit of the 95% confidence interval is higher than the -0.5 °C.|Mean Difference (Final Values)|-0.12||||0.018|TWO_SIDED|95.0|-0.37|0.14||P-value was adjusted for preoperative oral temperature and ASA physical status.|t-test, 1 sided||Non-inferiority will be established, at the 0.025 significance level, if the lower limit of a 95% confidence interval for the difference is above -0.5 °C.|Null hypothesis is the Hot dog resistive heating system is inferior to the Bair Hugger forced air system. Mean difference (95% CI) of the intraoperative TWA temperature between the groups (resistive heating versus forced-air) will be adjusting for preoperative oral temperature and ASA physical status.||0.14|-0.37|0.018
70939352|NCT02604199|141379375|SUPERIORITY||LS Mean|-0.338|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001|TWO_SIDED|95.0|-0.433|-0.243||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 71||-0.243|-0.433|<.0001
70939353|NCT02604199|141379375|SUPERIORITY||LS Mean|-0.206|STANDARD_ERROR_OF_MEAN|0.049||0.0001|TWO_SIDED|95.0|-0.304|-0.108||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 71||-0.108|-0.304|0.0001
70941956|NCT00714688|141384217|SUPERIORITY_OR_OTHER|||||||0.002||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|The ANCOVA model has been performed on ranked data. Treatment, gender and country were used as factors and age was used as a covariate.||||||0.002
70852896|NCT03745820|141194620|SUPERIORITY||LS Mean Difference|-1.51|STANDARD_ERROR_OF_MEAN|1.597|=|0.3455|TWO_SIDED|95.0|-4.66|1.64||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Visual Learning: Change From Baseline at Week 12||1.64|-4.66|=0.3455
70852897|NCT03745820|141194620|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|1.595|=|0.9686|TWO_SIDED|95.0|-3.09|3.21||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Visual Learning: Change From Baseline at Week 12||3.21|-3.09|=0.9686
70939354|NCT02604199|141379375|SUPERIORITY||LS Mean|-0.096|STANDARD_ERROR_OF_MEAN|0.05||0.0589|TWO_SIDED|95.0|-0.195|0.004||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 85||0.004|-0.195|0.0589
71071242|NCT01258075|141651419|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.21||0.5494|TWO_SIDED|95.0|-0.54|0.29|||ANCOVA|Based on a mixed effect ANCOVA model with treatment and previous type 2 diabetes treatment stratum as fixed effects and baseline as a covariate.||||0.29|-0.54|0.5494
71071243|NCT01500213|141651426|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.043|TWO_SIDED|95.0|1.0|2.1||To control for multiplicity, analyses were performed hierarchically. For the CR delayed the threshold for statistical significance was 0.05; no further adjustment for multiplicity were required for the primary endpoint.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.1|1.0|0.043
71071244|NCT01500213|141651427|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.233|TWO_SIDED|95.0|0.8|2.0||To control for multiplicity, analyses were performed hierarchically. CR-acute was tested only if the result for the primary endpoint, CR delayed, was statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.0|0.8|0.233
71071245|NCT01500213|141651428|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.084|TWO_SIDED|95.0|1.0|1.9||To control for multiplicity, analyses were performed hierarchically. CR overall was tested only if both CR delayed and CR acute were statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||1.9|1.0|0.084
71071246|NCT03197870|141651432|SUPERIORITY|The primary hypotheses was tested in the modified intent-to-treat population using a Fisher's Exact Test with a 2-sided 5% significance level. razuprotafib 15 mg twice daily was tested first. If this was found to be statistically significant, then razuprotafib 15 mg once daily will be tested for statistical significance, at the same significance level.||||||0.495||||||Missing data was imputed using last observation carried forward; baseline values were not carried forward.|Fisher Exact|||The primary hypotheses tested was that razuprotafib 15 mg twice daily and razuprotafib 15 mg once daily will be superior to placebo in the improvement of diabetic retinopathy as measured by the Early Treatment Diabetic Retinopathy Study severity scale change from baseline at 48 weeks.||||0.495
71071247|NCT05174949|141651453|SUPERIORITY|We performed a linear regression analysis (generalized estimating equations) in which we compared both intervention groups to the sham group and added a time interaction term|Mean Difference (Final Values)|5.4|STANDARD_DEVIATION|3.58|<|0.0001|TWO_SIDED|95.0|2.4|8.4||Anode compared to sham: p = 0.0516 Cathode compared to sham: p \<.0001 . Anode change over time compared to sham p=0.0255 Cathode change over time compared to sham p\<.0001|Generalized Estimating Equations||Anode mean change = 4.13 std = 4.29 CLM = 0.5-7.7 Cathode mean change = 5.38 std = 3.58 CLM=2.4-8.4|We will report first anode compared to sham and then cathode compared to sham||8.4|2.4|<0.0001
71071248|NCT05174949|141651454|SUPERIORITY||Mean Difference (Final Values)|-24.2|STANDARD_DEVIATION|9.5||0.002|TWO_SIDED|95.0|-32.2|-16.2||anode compared to sham p= 0.0020 cathode compared to sham p = 0.0088 anode over time anode compared to sham p \<.0001 Cathode over time compared to sham p \<.0001|Regression, Cox||anode -24.2 (-32.2, -16.2) cathode -22.2 (-30.6, -13.8)|We compared anode to sham We compared cathode to sham We compared the change over time of anode to sham We compared the change over time of cathode to shal||-16.2|-32.2|0.0020
70852898|NCT03745820|141194620|SUPERIORITY||LS Mean Difference|1.18|STANDARD_ERROR_OF_MEAN|1.351|=|0.3832|TWO_SIDED|95.0|-1.49|3.85||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Social Cognition: Change From Baseline at Week 12||3.85|-1.49|=0.3832
70939355|NCT02604199|141379375|SUPERIORITY||LS Mean|-0.335|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001|TWO_SIDED|95.0|-0.433|-0.236||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 85||-0.236|-0.433|<.0001
71071249|NCT05174949|141651455|SUPERIORITY||Mean Difference (Final Values)|0.077||||0.0001|TWO_SIDED|95.0|0.0|0.1||Compare anode to sham p= 0.0001 Compare cathode to sham p=0.1073 Compare anode change in time to sham p=0.0938 Compare cathode change in time to sham 0.0068|Regression, Linear|Using generalized estimating equations with group and time component|Anode = 0.077 (0.00, 0.10) Cathode = -.0.125 (-0.32 0.07 )|e compare anode to sham We compare cathode to sham||0.10|0.00|0.0001
71114076|NCT00335283|141736004|SUPERIORITY_OR_OTHER||Odds Ratio, log|5.17||||0.006|TWO_SIDED|95.0|2.02|13.2|||Regression, Logistic|||This applies to the 8 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||13.2|2.02|.006
71114077|NCT00335283|141736004|SUPERIORITY_OR_OTHER||Odds Ratio, log|5.31||||0.001|TWO_SIDED|95.0|1.97|14.3|||Regression, Logistic|||This applies to the 16 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||14.3|1.97|.001
71071250|NCT02880865|141651456|NON_INFERIORITY|Non-inferiority was achieved if the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentages of participants with seropositivity between the two groups (concurrent administration minus separate administration) at 56 days post-vaccination was \> -10% for both measles and rubella results.|Difference|0.0|||||TWO_SIDED|95.0|-2.1|2.2||||||The primary hypotheses evaluated the non-inferiority of the concomitant administration of MMR and CD-JEV vaccines (Group 1) to MMR and CD-JEV vaccines given 2 months apart (Group 2) in children 9 months of age at 56 days in terms of percentage of participants achieving seropositivity to measles and rubella assuming a non-inferiority margin of 10%.||2.2|-2.1|
71071251|NCT02880865|141651457|NON_INFERIORITY|Non-inferiority was achieved if the lower limit of the two-sided 95% CI for the difference in percentages of participants with seropositivity between the two groups (concurrent administration minus separate administration) at 56 days post-vaccination was \> -10% for both measles and rubella results.|Difference|0.3|||||TWO_SIDED|95.0|-0.3|1.0||||||The primary hypotheses evaluated the non-inferiority of the concomitant administration of MMR and CD-JEV vaccines (Group 1) to MMR and CD-JEV vaccines given 2 months apart (Group 2) in children 9 months of age at 56 days in terms of percentage of participants achieving seropositivity to measles and rubella assuming a non-inferiority margin of 10%.||1.0|-0.3|
71071252|NCT02880865|141651458|NON_INFERIORITY|The percentage of participants with seropositivity for mumps at 56 days post-vaccination between Group 1 and Group 2 were compared using a non-inferiority test. Non-inferiority of Group 1 to Group 2 in terms of seropositivity for mumps was demonstrated if the lower limit of the two-sided 95% CI for the difference of seropositivity rates between the two groups (concurrent administration minus separate administration) at 56 days post-vaccination was \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-2.0|2.1||||||||2.1|-2.0|
71071253|NCT02880865|141651459|OTHER||GMC Ratio|1.1|||||TWO_SIDED|95.0|0.9|1.2|||||Group 1/Group 2 ratio obtained using analysis of covariance (ANCOVA) with log10-transformed antibody concentration as dependent variable and treatment group as the explanatory variable adjusted for log10-transformed baseline antibody concentration.|||1.2|0.9|
71114078|NCT03086408|141736048|OTHER||Mean Difference (Final Values)|-4.0||||0.09|TWO_SIDED|95.0|-9.0|1.0|||t-test, 2 sided|||||1.00|-9.00|0.09
71114079|NCT03086408|141736049|OTHER||Mean Difference (Final Values)|0.9||||0.61|TWO_SIDED|95.0|-2.89|4.69|||t-test, 2 sided|||||4.69|-2.89|0.61
70852899|NCT03745820|141194620|SUPERIORITY||LS Mean DIfference|1.07|STANDARD_ERROR_OF_MEAN|1.357|=|0.4297|TWO_SIDED|95.0|-1.61|3.75||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Social Cognition: Change From Baseline at Week 12||3.75|-1.61|=0.4297
71114080|NCT03086408|141736050|OTHER||Mean Difference (Final Values)|-0.07||||0.78|TWO_SIDED|95.0|-0.61|0.47|||t-test, 2 sided|||||0.47|-0.61|0.78
71114081|NCT03086408|141736051|OTHER||Mean Difference (Final Values)|-0.4||||0.3|TWO_SIDED|95.0|-1.3|0.5|||t-test, 2 sided|||||0.50|-1.30|0.30
71114082|NCT03086408|141736052|OTHER||Mean Difference (Final Values)|0.1||||0.98|TWO_SIDED|95.0|-8.62|8.82|||t-test, 2 sided|||||8.82|-8.62|0.98
71114083|NCT03086408|141736053|OTHER||Mean Difference (Final Values)|0.6||||0.61|TWO_SIDED|95.0|-1.64|2.84|||t-test, 2 sided|||||2.84|-1.64|0.61
71071254|NCT02880865|141651460|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.9|1.1|||||Group 1/Group 2 ratio obtained using an ANCOVA method with log 10-transformed antibody concentration as dependent variable and treatment group as explanatory variable adjusted for log 10-transformed baseline antibody concentration.|||1.1|0.9|
71114084|NCT03086408|141736054|OTHER||Mean Difference (Final Values)|13.7||||0.04|TWO_SIDED|95.0|0.63|26.77|||t-test, 2 sided|||||26.77|0.63|0.04
71114085|NCT03086408|141736055|OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-2.8|2.8|||t-test, 2 sided|||||2.80|-2.80|1
71114086|NCT03086408|141736056|OTHER||Mean Difference (Final Values)|-0.2||||0.82|TWO_SIDED|95.0|-2.38|1.98|||t-test, 2 sided|||||1.98|-2.38|0.82
71114087|NCT03086408|141736057|OTHER||Mean Difference (Final Values)|-1.5||||0.37|TWO_SIDED|95.0|-5.29|2.29|||t-test, 2 sided|||||2.29|-5.29|0.37
71114088|NCT03367403|141736058|SUPERIORITY||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|1.56||0.042|TWO_SIDED|95.0|0.12|6.27|||Mixed Models Analysis|||||6.27|0.12|0.042
71114089|NCT03367403|141736059|SUPERIORITY||Mean Difference (Final Values)|-1.86|STANDARD_ERROR_OF_MEAN|0.898||0.04|TWO_SIDED|95.0|-3.63|-0.09|||Mixed Models Analysis|||||-0.09|-3.63|0.040
71114090|NCT03367403|141736060|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.239||0.139|TWO_SIDED|95.0|-0.83|0.12|||Mixed Models Analysis|||||0.12|-0.83|0.139
70852900|NCT03745820|141194620|SUPERIORITY||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|1.438|=|0.6245|TWO_SIDED|95.0|-3.55|2.14||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Reasoning and Problem Solving: Change From Baseline at Week 12||2.14|-3.55|=0.6245
71071255|NCT02880865|141651461|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-2.1|2.2|||||Group 1 - Group 2|||2.2|-2.1|
71071256|NCT02880865|141651462|OTHER||Difference|1.6|||||TWO_SIDED|95.0|-1.8|4.9|||||Group 1 - Group 2|||4.9|-1.8|
71071257|NCT02880865|141651463|OTHER||Difference|0.3|||||TWO_SIDED|95.0|-0.3|1.0|||||Group 1 - Group 2|||1.0|-0.3|
71114091|NCT03367403|141736061|SUPERIORITY||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.525||0.227|TWO_SIDED|95.0|-0.4|1.67|||Mixed Models Analysis|||||1.67|-0.40|0.227
71071258|NCT02880865|141651464|OTHER||Difference|4.1|||||TWO_SIDED|95.0|-3.1|11.3||||||||11.3|-3.1|
71071259|NCT02880865|141651465|OTHER||GMT Ratio|1.2|||||TWO_SIDED|95.0|1.0|1.4|||||Group 1 / Group 2 ratio obtained using an analysis of covariance (ANCOVA) method with log 10-transformed antibody concentration as dependent variable and treatment group as explanatory variable adjusted for log 10-transformed baseline antibody titer.|||1.4|1.0|
71071260|NCT05129293|141651472|SUPERIORITY|||||||0.229|||||||ANCOVA|Adjusted for disease duration, SymptoMScreen depression and anxiety scores, and Test of Everyday Cognition baseline performance||||||0.229
71071261|NCT05129293|141651473|SUPERIORITY|||||||0.04|||||||ANCOVA|Adjusted for disease duration, SymptoMScreen depression and anxiety scores, and Test of Everyday Cognition baseline performance||||||0.040
71071262|NCT05129293|141651474|SUPERIORITY|||||||0.266|||||||ANCOVA|Adjusted for disease duration, SymptoMScreen depression and anxiety scores, and Test of Everyday Cognition baseline performance||||||0.266
71071263|NCT00860249|141651475|SUPERIORITY_OR_OTHER||||||<|0.017||95.0||||We used the Bonferroni calculation to adjust for the planned multiple comparisons among the three groups.|Chi-squared|||Please note that no analyses were performed as the trial was stopped due to low enrollment.||||<0.017
71114092|NCT03367403|141736062|SUPERIORITY||Mean Difference (Final Values)|1.21|STANDARD_ERROR_OF_MEAN|1.009||0.23|TWO_SIDED|95.0|-0.77|3.2|||Mixed Models Analysis|||||3.20|-0.77|0.230
71114093|NCT03367403|141736063|SUPERIORITY||Mean Difference (Final Values)|-85.06|STANDARD_ERROR_OF_MEAN|3.867|<|0.001|TWO_SIDED|95.0|-92.68|-77.43|||Mixed Models Analysis|||||-77.43|-92.68|<0.001
71114094|NCT03367403|141736064|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.56|TWO_SIDED|95.0|-0.01|0.03|||ANCOVA|||Tau-IQ||0.03|-0.01|0.560
71114095|NCT03367403|141736064|SUPERIORITY||Mean Difference (Final Values)|0.035||||0.012|TWO_SIDED|95.0|0.007|0.062|||ANCOVA|||MUBADA-Cerebellum||0.062|0.007|0.012
71114096|NCT03367403|141736065|SUPERIORITY||Mean Difference (Final Values)|-2.67|STANDARD_ERROR_OF_MEAN|0.631|<|0.001|TWO_SIDED|95.0|-3.92|-1.43|||Mixed Models Analysis|||Bilateral Cortical||-1.43|-3.92|< 0.001
71114097|NCT03367403|141736065|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.011||0.916|TWO_SIDED|95.0|-0.02|0.02|||Mixed Models Analysis|||Bilateral Entorhinal Cortex||0.02|-0.02|0.916
71114098|NCT03367403|141736065|SUPERIORITY|Bilateral Hippocampus|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.019||0.771|TWO_SIDED|95.0|-0.03|0.04|||Mixed Models Analysis|||||0.04|-0.03|0.771
71114099|NCT03367403|141736065|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.047||0.094|TWO_SIDED|95.0|-0.17|0.01|||Mixed Models Analysis|||Bilateral Inferior Parietal Lobe||0.01|-0.17|0.094
71114100|NCT03367403|141736065|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.011||0.052|TWO_SIDED|95.0|-0.04|0.0|||Mixed Models Analysis|||Bilateral Isthmuscingulate||0.00|-0.04|0.052
71114101|NCT03367403|141736065|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.118||0.005|TWO_SIDED|95.0|-0.57|-0.11|||Mixed Models Analysis|||Bilateral Lateral Parietal Lobe||-0.11|-0.57|0.005
71114102|NCT03367403|141736065|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.036||0.731|TWO_SIDED|95.0|-0.08|0.06|||Mixed Models Analysis|||Bilateral Medial Temporal Lobe||0.06|-0.08|0.731
71114103|NCT03367403|141736065|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.046|<|0.001|TWO_SIDED|95.0|-0.25|-0.07|||Mixed Models Analysis|||Bilateral Precuneus||-0.07|-0.25|<0.001
71114104|NCT03367403|141736065|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.114|<|0.001|TWO_SIDED|95.0|-0.62|-0.17|||Mixed Models Analysis|||Bilateral Prefrontal Lobe||-0.17|-0.62|<0.001
70939356|NCT02604199|141379375|SUPERIORITY||LS Mean|-0.239|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.34|-0.137||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 85||-0.137|-0.340|<.0001
70939357|NCT02604199|141379375|SUPERIORITY||LS Mean|-0.132|STANDARD_ERROR_OF_MEAN|0.052||0.0138|TWO_SIDED|95.0|-0.236|-0.028||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 99||-0.028|-0.236|0.0138
70939358|NCT02604199|141379375|SUPERIORITY||LS Mean|-0.355|STANDARD_ERROR_OF_MEAN|0.051|<|0.0001|TWO_SIDED|95.0|-0.458|-0.252||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 99||-0.252|-0.458|<.0001
70939359|NCT02604199|141379375|SUPERIORITY||LS Mean|-0.223|STANDARD_ERROR_OF_MEAN|0.053||0.0001|TWO_SIDED|95.0|-0.329|-0.117||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 99||-0.117|-0.329|0.0001
70939360|NCT01075815|141379449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0235||||0.8762|TWO_SIDED|95.0|-0.1546|0.1568|||Wilcoxon two sample test|||||0.1568|-0.1546|0.8762
71071264|NCT00860249|141651476|SUPERIORITY_OR_OTHER||||||<|0.017||95.0||||We intended to use a Bonferroni calculation to adjust for multiple comparisons among study arms.|Chi-squared|||Please note that no analyses were performed as the trial was stopped due to low enrollment.||||<0.017
70939361|NCT01075815|141379450|SUPERIORITY_OR_OTHER|||||||0.3589||95.0|||||ANOVA|||||||0.3589
71071265|NCT00174967|141651477|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
71071266|NCT00174967|141651477|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
71071267|NCT00174967|141651477|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
71071268|NCT00174967|141651478|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
71071269|NCT00174967|141651478|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
71071270|NCT00174967|141651478|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
71114105|NCT03367403|141736065|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.044|<|0.001|TWO_SIDED|95.0|-0.3|-0.12|||Mixed Models Analysis|||Bilateral Superior Temporal Lobe||-0.12|-0.30|<0.001
71114106|NCT03367403|141736065|SUPERIORITY||Mean Difference (Final Values)|2.28|STANDARD_ERROR_OF_MEAN|0.581|<|0.001|TWO_SIDED|95.0|1.14|3.43|||Mixed Models Analysis|||Bilateral Ventricles||3.43|1.14|< 0.001
70939362|NCT01075815|141379451|SUPERIORITY_OR_OTHER|||||||0.0629||95.0|||||Wilcoxon two sample test|||||||0.0629
71114107|NCT03367403|141736065|SUPERIORITY||Mean Difference (Final Values)|-4.58|STANDARD_ERROR_OF_MEAN|1.519||0.003|TWO_SIDED|95.0|-7.58|-1.59|||Mixed Models Analysis|||Bilateral Whole Brain||-1.59|-7.58|0.003
70939363|NCT01075815|141379452|SUPERIORITY_OR_OTHER|||||||0.4728||95.0|||||ANOVA|||||||0.4728
70939364|NCT01075815|141379453|SUPERIORITY_OR_OTHER|||||||0.095||95.0|||||Fisher Exact|||||||0.0950
70939365|NCT01075815|141379455|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9625||||0.9179|TWO_SIDED|95.0|0.4655|1.99|||Chi-squared|||||1.9900|0.4655|0.9179
70939366|NCT01075815|141379456|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.875||||0.7271|TWO_SIDED|95.0|0.4133|1.8524|||Chi-squared|||||1.8524|0.4133|0.7271
70939367|NCT01075815|141379457|SUPERIORITY_OR_OTHER|||||||0.3267||95.0|||||Wilcoxon two sample test|||||||0.3267
70939368|NCT01075815|141379458|SUPERIORITY_OR_OTHER|||||||0.4164||95.0|||||Wilcoxon two sample test|||||||0.4164
70939369|NCT01075815|141379459|SUPERIORITY_OR_OTHER|||||||0.5952||95.0|||||Wilcoxon two sample test|||||||0.5952
70939370|NCT01075815|141379461|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9444||||0.8852|TWO_SIDED|95.0|0.4347|2.0518|||Chi-squared|||||2.0518|0.4347|0.8852
70939371|NCT02907489|141379508|SUPERIORITY|||||||0.083||||||0.083 for 24 hours, Significant at P ≤ 0.05|Chi-squared|||||||0.083
71071271|NCT00174967|141651479|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
71071272|NCT00174967|141651479|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
71071273|NCT00174967|141651479|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
71071274|NCT00174967|141651480|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
71114108|NCT03367403|141736065|SUPERIORITY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.178|<|0.001|TWO_SIDED|95.0|-1.03|-0.33|||Mixed Models Analysis|||Bilateral Whole Temporal Lobe||-0.33|-1.03|<0.001
70939372|NCT02907489|141379508|SUPERIORITY|||||||0.041||||||0.041 for 48 hours, Significant at P ≤ 0.05|Chi-squared|||||||0.041
70939373|NCT02907489|141379508|SUPERIORITY|||||||0.063||||||0.063 for 72 hours, Significant at P ≤ 0.05|Chi-squared|||||||0.063
70939374|NCT02907489|141379509|SUPERIORITY|||||||0.982||||||0.982 for S1, Significant at P ≤ 0.05|Chi-squared|||||||0.982
70939375|NCT02907489|141379509|SUPERIORITY|||||||0.467||||||0.467 for S2, Significant at P ≤ 0.05|Chi-squared|||||||0.467
70939376|NCT02907489|141379509|SUPERIORITY|||||||0.01||||||0.01 for S3 Significant at P ≤ 0.05|Chi-squared|||||||0.01
70939377|NCT02066389|141379510|SUPERIORITY|||||||0.153||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.153
71071275|NCT00174967|141651480|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
71071276|NCT00174967|141651480|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
71071277|NCT00174967|141651481|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71071278|NCT00174967|141651481|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71071279|NCT00174967|141651481|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71071280|NCT00174967|141651482|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71071281|NCT00174967|141651482|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71114109|NCT03367403|141736065|SUPERIORITY||Mean Difference (Final Values)|-2.28|STANDARD_ERROR_OF_MEAN|0.987||0.022|TWO_SIDED|95.0|-4.23|-0.33|||Mixed Models Analysis|||Bilateral White Matter||-0.33|-4.23|0.022
71114110|NCT03470194|141736074|OTHER||||||=|0.002|||||||Wilcoxon (Mann-Whitney)|||||||=0.002
70939378|NCT02066389|141379510|SUPERIORITY|||||||0.018||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.018
70939379|NCT02066389|141379510|SUPERIORITY|||||||0.001||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.001
70939380|NCT02066389|141379510|SUPERIORITY|||||||0.008||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.008
70939381|NCT02066389|141379510|SUPERIORITY|||||||0.001||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.001
70939382|NCT02066389|141379511|SUPERIORITY|||||||0.034||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.034
70939383|NCT02066389|141379511|SUPERIORITY|||||||0.003||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.003
70939384|NCT02066389|141379511|SUPERIORITY|||||||0.002||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.002
70939385|NCT02066389|141379511|SUPERIORITY|||||||0.01||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.010
70939386|NCT02066389|141379511|SUPERIORITY|||||||0.012||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.012
70939387|NCT02066389|141379512|SUPERIORITY|||||||0.023||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.023
70939388|NCT02066389|141379512|SUPERIORITY|||||||0.003||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.003
70939389|NCT02066389|141379512|SUPERIORITY|||||||0.145||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.145
70939390|NCT02066389|141379512|SUPERIORITY|||||||0.007||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.007
70939391|NCT02066389|141379512|SUPERIORITY|||||||0.014||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.014
70939392|NCT02066389|141379513|SUPERIORITY|||||||0.005||||||Statistical tests were 1-sided at a significance level of 0.05.|Fisher Exact|||||||0.005
70939393|NCT02066389|141379513|SUPERIORITY||||||<|0.001||||||Statistical tests were 1-sided at a significance level of 0.05.|Fisher Exact|||||||<0.001
70939394|NCT02066389|141379513|SUPERIORITY|||||||0.01||||||Statistical tests were 1-sided at a significance level of 0.05.|Fisher Exact|||||||0.010
71071282|NCT00174967|141651482|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71071283|NCT00174967|141651483|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71071284|NCT00174967|141651483|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71071285|NCT00174967|141651483|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71071286|NCT00174967|141651484|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
70852901|NCT03745820|141194620|SUPERIORITY||LS Mean Difference|1.59|STANDARD_ERROR_OF_MEAN|1.436|=|0.2698|TWO_SIDED|95.0|-1.25|4.43||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Reasoning and Problem Solving: Change From Baseline at Week 12||4.43|-1.25|=0.2698
70939395|NCT02066389|141379513|SUPERIORITY|||||||0.002||||||Statistical tests were 1-sided at a significance level of 0.05.|Fisher Exact|||||||0.002
70939396|NCT02066389|141379513|SUPERIORITY|||||||0.024||||||Statistical tests were 1-sided at a significance level of 0.05.|Fisher Exact|||||||0.024
71071287|NCT00174967|141651484|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71071288|NCT00174967|141651484|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71071289|NCT00174967|141651485|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71071290|NCT00174967|141651485|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71071291|NCT00174967|141651485|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71071292|NCT00174967|141651486|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71071293|NCT00174967|141651486|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71071294|NCT00174967|141651486|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71114111|NCT00758069|141736095|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-25.9|||<|0.001||95.0|-34.2|-17.5||No multiplicity adjustment among the pairwise comparisons of sitagliptin against placebo|ANCOVA|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used for pairwise comparison|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used to estimate difference of two groups and its 95% confidence interval|||-17.5|-34.2|<0.001
71114112|NCT00758069|141736095|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-19.5|||<|0.001||95.0|-28.0|-11.1||No multiplicity adjustment among the pairwise comparisons of sitagliptin against placebo|ANCOVA|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used for pairwise comparison|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used to estimate difference of two groups and its 95% confidence interval|||-11.1|-28.0|<0.001
71114113|NCT00758069|141736096|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-19.3|||<|0.001||95.0|-26.6|-11.9||No multiplicity adjustment among the pairwise comparisons of sitagliptin against placebo|ANCOVA|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used for pairwise comparison|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used to estimate difference of two groups and its 95% confidence interval|||-11.9|-26.6|<0.001
71114114|NCT00758069|141736096|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-12.9|||<|0.001||95.0|-20.4|-5.4||No multiplicity adjustment among the pairwise comparisons of sitagliptin against placebo|ANCOVA|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used for pairwise comparison|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used to estimate difference of two groups and its 95% confidence interval|||-5.4|-20.4|<0.001
71114115|NCT03249909|141736134|NON_INFERIORITY|Analysis of the change in exudate status (Decrease, Equal/Unchanged, Increase) from baseline to 4 weeks in the treatment groups with the two-sided Sign test on the Intent To Treat (ITT) population at 95% confidence interval.||||||0.0019|||||||Sign test|||||||0.0019
70939397|NCT02066389|141379514|SUPERIORITY|||||||0.015||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.015
70939398|NCT02066389|141379514|SUPERIORITY|||||||0.008||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.008
71071295|NCT02031640|141651487|SUPERIORITY||Least Square Mean (LSM) Difference|0.034||||0.272|TWO_SIDED|95.0|-0.027|0.095|||ANCOVA|||||0.095|-0.027|0.272
71071296|NCT02031640|141651487|SUPERIORITY||LSM Difference|0.045||||0.1415|TWO_SIDED|95.0|-0.015|0.106|||ANCOVA|||||0.106|-0.015|0.1415
71071297|NCT02031640|141651487|SUPERIORITY||LSM Difference|-0.015||||0.6356|TWO_SIDED|95.0|-0.075|0.046|||ANCOVA|||||0.046|-0.075|0.6356
71071298|NCT02031640|141651487|SUPERIORITY||LSM Difference|0.04||||0.1932|TWO_SIDED|95.0|-0.02|0.1|||ANCOVA|||||0.1|-0.02|0.1932
71071299|NCT02031640|141651488|OTHER|The analysis of change from baseline in weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using a repeated measures mixed model with effects due to baseline weekly average of daily trough morning PEF, sex, age, treatment, time, and time-by-treatment interaction.|LSM Difference|10.616||||0.0036|TWO_SIDED|95.0|3.489|17.744|||Mixed Model for repeated measures|||||17.744|3.489|0.0036
71071300|NCT02031640|141651488|SUPERIORITY||LSM Difference|8.419||||0.0204|TWO_SIDED|95.0|1.309|15.53|||Mixed Model for repeated measures|||The analysis of change from baseline in weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using a repeated measures mixed model with effects due to baseline weekly average of daily trough morning PEF, sex, age, treatment, time, and time-by-treatment interaction||15.53|1.309|0.0204
71114116|NCT02027311|141736149|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0||||For two-sided tests, p \< 0.05 was considered statistically significant.|Regression, Logistic|Logistic regression model used to identify the factors related to the presence of intervention (frequency of intervention = 0, vs. ≥ 1).||If the true difference in the experimental and control means is 4, total 26 experimental subjects and 26 control subjects was required to reject the null hypothesis that the means of the primary outcome values of experimental and control groups are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05.||||0.05
71114117|NCT02027311|141736150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.09||||0.002|TWO_SIDED|95.0|2.41|50.94||Logistic regression model were used in univariate and corrected multivariate analyses to identify the factors related to the primary outcome variables, such as, presence of intervention (frequency of intervention = 0, vs. ≥ 1).|Regression, Logistic|||All the continuous variables were compared using the Mann-Whitney U test and dichotomous categorical variables was used and the Pearson chi-square with Fisher exact test. We used the linear mixed model to compare the differences of paired data, such as mean values of RR, SpO2, MAP, HR, and RSS at different time points of the two different sedation groups. For two-sided tests, p \< 0.05 was considered statistically significant.||50.94|2.41|0.002
70939399|NCT02066389|141379514|SUPERIORITY|||||||0.029||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.029
71071301|NCT02031640|141651488|SUPERIORITY||LSM Difference|6.004||||0.0984|TWO_SIDED|95.0|-1.121|13.129|||Mixed Model for repeated measures|||The analysis of change from baseline in weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using a repeated measures mixed model with effects due to baseline weekly average of daily trough morning PEF, sex, age, treatment, time, and time-by-treatment interaction||13.129|-1.121|0.0984
71071302|NCT02031640|141651488|SUPERIORITY||LSM Difference|12.512||||0.0006|TWO_SIDED|95.0|5.435|19.589|||Mixed Model for repeated measures|||The analysis of change from baseline in weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using a repeated measures mixed model with effects due to baseline weekly average of daily trough morning PEF, sex, age, treatment, time, and time-by-treatment interaction||19.589|5.435|0.0006
71071303|NCT02031640|141651489|SUPERIORITY||LSM Difference|9.147||||0.0139|TWO_SIDED|95.0|1.866|16.429|||Mixed Model for repeated measures|||||16.429|1.866|0.0139
71071304|NCT02031640|141651489|SUPERIORITY||LSM Difference|9.17||||0.0133|TWO_SIDED|95.0|1.914|16.425|||Mixed Model for repeated measures|||||16.425|1.914|0.0133
71071305|NCT02031640|141651489|SUPERIORITY||LSM Difference|4.088||||0.2704|TWO_SIDED|95.0|-3.191|11.367|||Mixed Model for repeated measures|||||11.367|-3.191|0.2704
71071306|NCT02031640|141651489|SUPERIORITY||LSM Difference|10.301||||0.0053|TWO_SIDED|95.0|3.073|17.53|||Mixed Model for repeated measures|||||17.53|3.073|0.0053
71071307|NCT02031640|141651490|SUPERIORITY||LSM Difference|-0.703|||<|0.0001|TWO_SIDED|95.0|-1.044|-0.363|||Mixed Model for repeated measures|||||-0.363|-1.044|<0.0001
71071308|NCT02031640|141651490|SUPERIORITY||LSM Difference|-0.691|||<|0.0001|TWO_SIDED|95.0|-1.029|-0.352|||Mixed Model for repeated measures|||||-0.352|-1.029|<0.0001
70939400|NCT02066389|141379514|SUPERIORITY|||||||0.003||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.003
70939401|NCT02066389|141379514|SUPERIORITY|||||||0.343||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.343
70939402|NCT02066389|141379515|SUPERIORITY|||||||0.039||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.039
70939403|NCT02066389|141379515|SUPERIORITY|||||||0.039||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.039
70939404|NCT02066389|141379515|SUPERIORITY|||||||0.046||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.046
70939405|NCT02066389|141379515|SUPERIORITY|||||||0.005||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.005
71071309|NCT02031640|141651490|SUPERIORITY||LSM Difference|-0.651||||0.0002|TWO_SIDED|95.0|-0.994|-0.309|||Mixed Model for repeated measures|||||-0.309|-0.994|0.0002
71071310|NCT02031640|141651490|SUPERIORITY||LSM difference|-0.801|||<|0.0001|TWO_SIDED|95.0|-1.138|-0.464|||Mixed Model for repeated measures|||||-0.464|-1.138|<0.0001
71071311|NCT02031640|141651491|SUPERIORITY||Mean Difference (Final Values)|-0.149||||0.0119|TWO_SIDED|95.0|-0.265|-0.033|||Mixed Models Analysis|||||-0.033|-0.265|0.0119
71071312|NCT02031640|141651491|SUPERIORITY||Mean Difference (Final Values)|-0.102||||0.0854|TWO_SIDED|95.0|-0.217|0.014|||Mixed Models Analysis|||||0.014|-0.217|0.0854
71071313|NCT02031640|141651491|SUPERIORITY||Mean Difference (Final Values)|-0.189||||0.0016|TWO_SIDED|95.0|-0.306|-0.072|||Mixed Models Analysis|||||-0.072|-0.306|0.0016
71071314|NCT02031640|141651491|SUPERIORITY||Mean Difference (Final Values)|-0.216||||0.0003|TWO_SIDED|95.0|-0.332|-0.101|||Mixed Models Analysis|||||-0.101|-0.332|0.0003
71071315|NCT03085238|141651499|NON_INFERIORITY|The primary safety endpoint will be analyzed using a unilateral one sample test for binomial proportion at the 5% level.||||||0.1309|||||||unilateral one sample test for binomial|||H0: M-Trap freedom MAE incidence \<= 90% - Non-inferiority margin (25%)||||0.1309
71071316|NCT03085238|141651500|NON_INFERIORITY|The primary safety endpoint will be analyzed using a unilateral one sample test for binomial proportion at the 5% level.||||||0.0181|||||||unilateral one sample test for binomial|||H0: M-Trap freedom MAE incidence \<= 90% - Non-inferiority margin (25%)||||.0181
71071317|NCT02729038|141651531|OTHER||Ratio of geometric LS means|1.507|||||TWO_SIDED|90.0|0.902|2.519|||||AUC (0-inf) for participants with normal renal function Vs participants with moderate renal function has been presented.|||2.519|0.902|
71114118|NCT01825512|141736151|NON_INFERIORITY|Deferiprone was declared non inferior to Deferasirox if the lower limit of the 95% confidence interval for the difference in the proportion of successful chelation in the two groups is above -12.5%.|Treatment success rate|-12.5|||||ONE_SIDED|95.0|-12.5||||||||||-12.5|
70852902|NCT03745820|141194621|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.61|=|0.4654|TWO_SIDED|95.0|-1.65|0.76||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Positive Symptoms Subscale: Change From Baseline at Week 12||0.76|-1.65|=0.4654
70939406|NCT02066389|141379515|SUPERIORITY|||||||0.096||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.096
71071318|NCT02729038|141651531|OTHER||Ratio of geometric LS means|1.924|||||TWO_SIDED|90.0|1.151|3.215|||||AUC (0-inf) for participants with normal renal function Vs participants with Severe/ESRD not on hemodialysis|||3.215|1.151|
71071319|NCT02729038|141651532|OTHER||Ratio of geometric LS means|2.375|||||TWO_SIDED|90.0|1.421|3.969|||||AUC (0-inf) for participants with normal renal function Vs ESRD on hemodialysis (before hemodialysis)|||3.969|1.421|
71071320|NCT02729038|141651532|OTHER||Ratio of geometric LS means|4.075|||||TWO_SIDED|90.0|2.438|6.81|||||AUC (0-inf) for participants with normal renal function Vs ESRD on hemodialysis (after hemodialysis)|||6.810|2.438|
71071321|NCT02729038|141651533|OTHER||Ratio of geometric LS means|1.179|||||TWO_SIDED|90.0|0.467|2.977|||||Cmax for participants with normal renal function Vs participants with moderate renal function has been presented.|||2.977|0.467|
71071322|NCT02729038|141651533|OTHER||Ratio of geometric LS means|1.575|||||TWO_SIDED|90.0|0.624|3.975|||||Cmax for participants with normal renal function Vs .participants with Severe/ESRD not on hemodialysis|||3.975|0.624|
71071323|NCT02729038|141651534|OTHER||Ratio of geometric LS means|2.25|||||TWO_SIDED|90.0|0.891|5.681|||||Cmax for participants with normal renal function Vs ESRD on hemodialysis (before hemodialysis)|||5.681|0.891|
71071324|NCT02729038|141651534|OTHER||Ratio of geometric LS means|5.966|||||TWO_SIDED|90.0|2.363|15.062|||||Cmax for participants with normal renal function Vs ESRD on hemodialysis (after hemodialysis)|||15.062|2.363|
71071325|NCT02729038|141651556|OTHER||Ratio of geometric LS means|1.501|||||TWO_SIDED|90.0|0.894|2.52|||||Normal Vs Moderate|||2.520|0.894|
71071326|NCT02729038|141651556|OTHER||Ratio of geometric LS means|1.912|||||TWO_SIDED|90.0|1.139|3.212|||||Normal Vs Severe/ESRD not on hemodialysis|||3.212|1.139|
71071327|NCT02729038|141651557|OTHER||Ratio of geometric LS means|2.375|||||TWO_SIDED|90.0|1.414|3.989|||||Normal Vs ESRD on hemodialysis (before hemodialysis)|||3.989|1.414|
70939407|NCT02066389|141379516|SUPERIORITY|||||||0.269||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.269
70939408|NCT02066389|141379516|SUPERIORITY|||||||0.16||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.160
70939409|NCT02066389|141379516|SUPERIORITY|||||||1||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||1.000
70939410|NCT02066389|141379516|SUPERIORITY|||||||0.16||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.160
70939411|NCT02066389|141379516|SUPERIORITY|||||||1||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||1.000
70939412|NCT00762853|141379517|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70941957|NCT00714688|141384218|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|-4.2|STANDARD_ERROR_OF_MEAN|1.86||0.023||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|Treatment, gender and country were used as factors and baseline value and age were used as covariates.||Statistical analysis of change from baseline at endpoint.||||0.023
71071328|NCT02729038|141651557|OTHER||Ratio of geometric LS means|4.068|||||TWO_SIDED|90.0|2.422|6.831|||||Normal Vs ESRD on hemodialysis (after hemodialysis)|||6.831|2.422|
71071329|NCT02822573|141651574|SUPERIORITY|Mixed effects repeated measures analysis of covariance (RMANCOVA) models with covariates of treatment, time, time by treatment interaction, baseline outcome level, age stratification and an unstructured covariance matrix. The primary objective was assessed using a linear contrast of group effect at 24 weeks.||||||0.32|||||||ANCOVA|||With a sample size of 266, there was 90% power to detect a treatment difference of 2 words for HVLT-R total recall score (SD=4.26, effect size=0.47) with a two-sided 5% level of significance. This calculation assumed an ANCOVA model analysis with 25% dropout and 2% missing data at end of treatment. A single interim analysis for futility occurred after 138 participants, with stopping rule of two-sided p-value \< 0.0154. This design required 3.5% more than fixed design, increasing total to 276.||||0.32
71071330|NCT00308087|141651592|SUPERIORITY_OR_OTHER|||||||0.6182||95.0||||"Exact Conditional Test is stratified on the number~\> of prior therapies (1 or 2, 3 or more prior therapies)."|2-sided Exact Conditional Test|||||||0.6182
71071331|NCT00308087|141651595|SUPERIORITY_OR_OTHER|||||||0.5501||95.0|||||Log Rank|||Log rank analysis is a comparison between treatment groups of the distribution of time to first progressive disease or death.||||0.5501
71071332|NCT00308087|141651596|SUPERIORITY_OR_OTHER|||||||0.8217||95.0|||||Log Rank|||Log rank analysis is a comparison between treatment groups of the distribution of time to first progressive disease or death.||||0.8217
71071333|NCT00135798|141651598|SUPERIORITY_OR_OTHER|||||||0.0477||95.0||||One-sided test|Fisher Exact|||ITT analysis of pTVR: 0/13 Standard care vs. 11/46 Combined LADR-treated groups||||0.0477
71071334|NCT00135798|141651598|SUPERIORITY_OR_OTHER|||||||0.609||95.0|||||Chi-squared|||ITT analysis of LADR-treated: 5/24 Genotypes 1,4,6 vs 6/22 Genotypes 2,3||||0.6090
71071335|NCT00135798|141651599|SUPERIORITY_OR_OTHER|||||||0.2014||95.0||||One-sided test|Fisher Exact|||ITT analysis of CVR: 1/16 Standard care vs. 12/63 Combined LADR-treated groups||||0.2014
71071336|NCT00135798|141651599|SUPERIORITY_OR_OTHER|||||||0.9513||95.0|||||Chi-squared|||ITT analysis of LADR-treated: 6/31 Genotypes 1,4,6 vs 6/32 Genotypes 2,3||||0.9513
71071337|NCT00135798|141651600|SUPERIORITY_OR_OTHER|||||||0.0274||95.0||||One-sided test|Fisher Exact|||PP analysis of pTVR: 0/13 Standard care vs. 11/44 Combined LADR-treated groups||||0.0274
71071338|NCT00135798|141651600|SUPERIORITY_OR_OTHER|||||||0.6011||95.0|||||Chi-squared|||PP analysis of LADR-treated: 5/23 G1,4,6 vs 6/21 G2,3||||0.6011
71071339|NCT00135798|141651601|SUPERIORITY_OR_OTHER|||||||0.0153||95.0||||One-sided test|Fisher Exact|||PP analysis of CVR: 0/20 Standard care vs. 13/59 Combined LADR-treated groups||||0.0153
71114119|NCT01825512|141736152|OTHER|GLM model|Mean Difference (Final Values)|2.128|STANDARD_ERROR_OF_MEAN|1.18||0.074|TWO_SIDED|95.0|-0.213|4.468|||ANCOVA|||||4.468|-0.213|0.074
71071340|NCT00135798|141651601|SUPERIORITY_OR_OTHER|||||||0.8065||95.0|||||Chi-squared|||PP analysis of LADR-treated: 7/30 G1,4,6 vs 6/29 G2,3||||0.8065
71071341|NCT04186806|141651605|NON_INFERIORITY|Non-inferiority margin was 1.5 cm|Mean Difference (Final Values)|-0.3426|||||TWO_SIDED|95.0|-1.2601|0.5749||The conclusion of the non-inferiority test is based on the 95% confidence interval and not on a p value. A p value was not computed.|Mixed Models Analysis||Non-inferiority testing was carried out using 95% confidence intervals.|||0.5749|-1.2601|
71071342|NCT01542034|141651671|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.702|||<|0.001|TWO_SIDED|95.0|2.808|4.88|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) method stratified by pooled study center.|A risk ratio greater than 1 favors deoxycholic acid injection treatment, and between 0 and 1 favors placebo.|The primary analysis was satisfied if both null hypotheses (there is no treatment difference in 1-grade or 2-grade response rate) were rejected in favor of the two-tailed alternative at the 0.05 level of significance for both primary efficacy endpoints, and the response rates were higher for the deoxycholic acid injection treatment group than the placebo group. Because both hypotheses must be rejected, the type I error was preserved when testing the primary endpoints.||4.880|2.808|<0.001
71071343|NCT01542034|141651672|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method stratified by pooled study center.||The primary analysis was satisfied if both null hypotheses (there is no treatment difference in 1-grade or 2-grade response rate) were rejected in favor of the two-tailed alternative at the 0.05 level of significance for both primary efficacy endpoints, and the response rates were higher for the deoxycholic acid injection treatment group than the placebo group. Because both hypotheses must be rejected, the type I error was preserved when testing the primary endpoints.||||<0.001
71071344|NCT01542034|141651673|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|8.541|||<|0.001|TWO_SIDED|95.0|3.62|20.148|||Cochran-Mantel-Haenszel|CMH method stratified by pooled study center|A risk ratio greater than 1 favors deoxycholic acid injection treatment, and between 0 and 1 favors placebo.|If both primary endpoints were statistically significant, testing continued to the 2 secondary endpoints using the Bonferroni-Holm method. The smaller of the 2 p-values for the treatment difference was tested at the 0.025 level. If significant, testing proceeded for the remaining secondary endpoint at the 0.05 level. If the smaller p-value was \> 0.025, the null hypothesis for the associated variable would not be rejected, and testing of the second endpoint would not proceed.||20.148|3.620|<0.001
71071345|NCT01542034|141651674|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|Analysis of covariance (ANCOVA) model included treatment and Baseline PR-SMFIS total scale score.||If both primary endpoints were statistically significant, testing continued to the 2 secondary endpoints using the Bonferroni-Holm method. The smaller of the 2 p-values for the treatment difference was tested at the 0.025 level. If significant, testing proceeded for the remaining secondary endpoint at the 0.05 level. If the smaller p-value was \> 0.025, the null hypothesis for the associated variable would not be rejected, and testing of the second endpoint would not proceed.||||<0.001
71071346|NCT02612610|141651675|OTHER||LS Mean Difference|-0.25||||0.0971|TWO_SIDED|95.0|-0.54|0.05|||Mixed Effect Repeated Measures model|||Estimated treatment differences (gefapixant vs. placebo) and corresponding 95% confidence intervals (CIs) were estimated using a mixed effect repeated measures (MMRM) model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.||0.05|-0.54|0.0971
71071347|NCT02612610|141651675|OTHER||LS Mean Difference|-0.25||||0.0928|TWO_SIDED|95.0|-0.54|0.04|||Mixed Effect Repeated Measures model|||Estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.||0.04|-0.54|0.0928
71071348|NCT02612610|141651675|OTHER||LS Mean Difference|-0.46||||0.0027|TWO_SIDED|95.0|-0.76|-0.16|||Mixed Effect Repeated Measures model|||Estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.||-0.16|-0.76|0.0027
71071349|NCT02612610|141651676|OTHER||LS Mean Difference|-0.19||||0.1914|TWO_SIDED|95.0|-0.47|0.09|||Mixed Effect Repeated Measures model|||"Day 28 24-hour Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.09|-0.47|0.1914
71071350|NCT02612610|141651676|OTHER||LS Mean Difference|-0.05||||0.7099|TWO_SIDED|95.0|-0.33|0.23|||Mixed Effect Repeated Measures model|||"Day 28 24-hour Cough Frequency: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.23|-0.33|0.7099
71071351|NCT02612610|141651676|OTHER||LS Mean Difference|-0.52||||0.0003|TWO_SIDED|95.0|-0.8|-0.24|||Mixed Effect Repeated Measures model|||"Day 28 24-hour Cough Frequency: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.24|-0.80|0.0003
71071352|NCT02612610|141651677|OTHER||LS Mean Difference|-0.4||||0.0099|TWO_SIDED|95.0|-0.71|-0.1|||Mixed Effect Repeated Measures model|||"Day 56 24-hour Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.10|-0.71|0.0099
71071353|NCT02612610|141651677|OTHER||LS Mean Difference|-0.28||||0.0695|TWO_SIDED|95.0|-0.58|0.02|||Mixed Effect Repeated Measures model|||"Day 56 24-hour Cough Frequency: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.02|-0.58|0.0695
71114120|NCT01825512|141736153|OTHER|GLM Analysis|Mean Difference (Final Values)|-0.633|STANDARD_ERROR_OF_MEAN|1.741||0.717|TWO_SIDED|95.0|-4.085|2.819|||ANCOVA|||||2.819|-4.085|0.717
70939413|NCT01755598|141379518|OTHER|Vaccine efficacy (VE) has been estimated from a Cox proportional hazard regression model (VE=1-hazard ratio) and 90% confidence intervals (CIs) and Wald p-value has been derived. The lower limit of the 90% two-sided CI for the VE against first occurrence of Definite pulmonary TB disease not associated with HIV-infection, meeting the case definition 1, is to be above 0%.|Vaccine efficacy rate|49.7||||0.043|TWO_SIDED|90.0|12.1|71.2|||Regression, Cox|||To evaluate the protective efficacy of two doses of the M72/AS01E candidate vaccine against Definite pulmonary TB disease not associated with HIV-infection, meeting the case definition 1, as compared to placebo.||71.2|12.1|0.0430
71071354|NCT02612610|141651677|OTHER||LS Mean Difference|-0.62||||0.0001|TWO_SIDED|95.0|-0.93|-0.31|||Mixed Effect Repeated Measures model|||"Day 56 24-hour Cough Frequency: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.31|-0.93|0.0001
71071355|NCT02612610|141651678|OTHER||LS Mean Difference|-0.24||||0.0991|TWO_SIDED|95.0|-0.52|0.04|||Mixed Effect Repeated Measures model|||"Day 84 24-hour Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.04|-0.52|0.0991
71071356|NCT02612610|141651678|OTHER||LS Mean Difference|-0.25||||0.0811|TWO_SIDED|95.0|-0.53|0.03|||Mixed Effect Repeated Measures model|||"Day 84 24-hour Cough Frequency: 20 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.03|-0.53|0.0811
71071357|NCT02612610|141651678|OTHER||LS Mean Difference|-0.47||||0.0014|TWO_SIDED|95.0|-0.76|-0.19|||Mixed Effect Repeated Measures model|||"Day 84 24-hour Cough Frequency: 50 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.19|-0.76|0.0014
71071358|NCT02612610|141651679|OTHER||LS Mean Difference|-0.21||||0.1468|TWO_SIDED|95.0|-0.5|0.07|||Mixed Effect Repeated Measures model|||"Day 28 Awake Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate. ."||0.07|-0.50|0.1468
71071359|NCT02612610|141651679|OTHER||LS Mean Difference|-0.08||||0.5874|TWO_SIDED|95.0|-0.36|0.2|||Mixed Effect Repeated Measures model|||"Day 28 Awake Cough Frequency: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.20|-0.36|0.5874
71071360|NCT02612610|141651679|OTHER||LS Mean Difference|-0.49||||0.0008|TWO_SIDED|95.0|-0.78|-0.21|||Mixed Effect Repeated Measures model|||"Day 28 24-hour Cough Frequency: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.21|-0.78|0.0008
71071361|NCT02612610|141651680|OTHER||Mixed Effect Repeated Measures model|-0.39||||0.0177|TWO_SIDED|95.0|-0.7|-0.07|||Mixed Effect Repeated Measures model|||"Day 56 Awake Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.07|-0.70|0.0177
71071362|NCT02612610|141651680|OTHER||LS Mean Difference|-0.32||||0.0498|TWO_SIDED|95.0|-0.63|0.0|||Mixed Effect Repeated Measures model|||"Day 56 Awake Cough Frequency: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.00|-0.63|0.0498
71071363|NCT02612610|141651680|OTHER||LS Mean Difference|-0.59||||0.0004|TWO_SIDED|95.0|-0.92|-0.27|||Mixed Effect Repeated Measures model|||"Day 56 Awake Cough Frequency: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.27|-0.92|0.0004
71114121|NCT01825512|141736154|NON_INFERIORITY|Non inferiority of Deferiprone to Deferasirox is tested considering a non-inferiority margin of 400 ng/mL.|Mean Difference (Final Values)|0.601|STANDARD_ERROR_OF_MEAN|164.734||0.997|TWO_SIDED|95.0|-323.58|324.781|||GLM|||||324.781|-323.580|0.997
71114122|NCT02466425|141736155|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-9.9|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|95.0|-13.0|-6.8|||Mixed-effects model for repeated measure||Between treatment groups|||-6.8|-13.0|<0.001
71114123|NCT03231917|141736181|OTHER|||||||0.48|||||||Chi-squared|||||||0.48
70941958|NCT00714688|141384218|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|-4.4|STANDARD_ERROR_OF_MEAN|1.83||0.016||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|Treatment, gender and country were used as factors and baseline value and age were used as covariates.||Statistical analysis of change from baseline at endpoint.||||0.016
71071364|NCT02612610|141651682|OTHER||LS Mean Difference|-6.4||||0.1318|TWO_SIDED|95.0|-14.8|1.9|||Mixed Effect Repeated Measures model|||"Day 28 Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||1.9|-14.8|0.1318
71114124|NCT01901289|141736198|OTHER||Cumulative Probability|0.927|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.881|0.956|||||The estimate of the variance of the Kaplan-Meier estimate used the methods described by Peto et al.|||0.956|0.881|
71114125|NCT01813058|141736199|SUPERIORITY||Mean Difference (Final Values)|195.0|||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
70852903|NCT03745820|141194621|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.608|=|0.5886|TWO_SIDED|95.0|-1.53|0.87||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Positive Symptoms Subscale: Change From Baseline at Week 12||0.87|-1.53|=0.5886
71071365|NCT02612610|141651682|OTHER||LS Mean Difference|-2.9||||0.4917|TWO_SIDED|95.0|-11.3|5.4|||Mixed Effect Repeated Measures model|||"Day 28 Cough Severity VAS: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||5.4|-11.3|0.4917
71071366|NCT02612610|141651682|OTHER||LS Mean Difference|-9.8||||0.0228|TWO_SIDED|95.0|-18.2|-1.4|||Mixed Effect Repeated Measures model|||"Day 28 Cough Severity VAS: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-1.4|-18.2|0.0228
71071367|NCT02612610|141651683|OTHER||LS Mean Difference|-2.6||||0.554|TWO_SIDED|95.0|-11.5|6.2|||Mixed Effect Repeated Measures model|||"Day 56 Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||6.2|-11.5|0.5540
71071368|NCT02612610|141651683|OTHER||LS Mean Difference|-3.2||||0.4702|TWO_SIDED|95.0|-12.0|5.6|||Mixed Effect Repeated Measures model|||"Day 56 Cough Severity VAS: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||5.6|-12.0|0.4702
71071369|NCT02612610|141651683|OTHER||LS Mean Difference|-10.7||||0.0197|TWO_SIDED|95.0|-19.8|-1.7|||Mixed Effect Repeated Measures model|||"Day 56 Cough Severity VAS: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-1.7|-19.8|0.0197
71071370|NCT02612610|141651684|OTHER||LS Mean Difference|-4.4||||0.302|TWO_SIDED|95.0|-12.9|4.0|||Mixed Effect Repeated Measures model|||"Day 84 Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||4.0|-12.9|0.3020
71071371|NCT02612610|141651684|OTHER||LS Mean Difference|-6.4||||0.1365|TWO_SIDED|95.0|-14.8|2.0|||Mixed Effect Repeated Measures model|||"Day 84 Cough Severity VAS: 20 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||2.0|-14.8|0.1365
71071372|NCT02612610|141651684|OTHER||LS Mean Difference|-11.2||||0.0108|TWO_SIDED|95.0|-19.7|-2.6|||Mixed Effect Repeated Measures model|||"Day 84 Cough Severity VAS: 50 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-2.6|-19.7|0.0108
71071373|NCT02612610|141651685|OTHER||LS Mean Difference|-4.0||||0.3509|TWO_SIDED|95.0|-12.3|4.4|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||4.4|-12.3|0.3509
71071374|NCT02612610|141651685|OTHER||LS Mean Difference|-8.2||||0.0519|TWO_SIDED|95.0|-16.6|0.1|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-16.6|0.0519
71071375|NCT02612610|141651685|OTHER||LS Mean Difference|-15.9||||0.0003|TWO_SIDED|95.0|-24.3|-7.5|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination Cough Severity VAS: 50 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-7.5|-24.3|0.0003
71071376|NCT02612610|141651686|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1387|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1387
71114126|NCT00182078|141736202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8|STANDARD_DEVIATION|3.4|=|0.017|TWO_SIDED|95.0|||||t-test, 2 sided|||||||=0.017
71114127|NCT00182078|141736203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|STANDARD_DEVIATION|3.9|<|0.001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.001
71114128|NCT00182078|141736204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_DEVIATION|4.4|=|0.65|TWO_SIDED|95.0|||||t-test, 2 sided|||||||=0.65
71114129|NCT00893152|141736243|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
71114130|NCT00744380|141736310|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
71114131|NCT00744380|141736311|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||For open label midazolam||||0.25
71114132|NCT00744380|141736311|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon (Mann-Whitney)|||For all midazolam||||0.048
71114133|NCT00744380|141736311|SUPERIORITY_OR_OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||For fentanyl||||0.88
70939414|NCT01755598|141379519|OTHER|Vaccine efficacy (VE) has been estimated from a Cox proportional hazard regression model (VE=1-hazard ratio) and 90% confidence intervals (CIs) and Wald p-value has been derived. If the primary objective is met, this secondary objective is to be analysed using the following success criterion: The lower limit of the 90% two-sided CI for the VE against first occurrence of Definite pulmonary TB disease not associated with HIV infection, meeting the case definition 2, is to be above 0%.|Vaccine efficacy rate|61.67||||0.021|TWO_SIDED|90.0|24.084|80.647|||Regression, Cox|||To evaluate the protective efficacy of two doses of the M72/AS01E candidate vaccine against Definite Xpert MTB/Rif positive pulmonary TB disease not associated with HIV-infection, meeting the case definition 2, as compared to placebo.||80.647|24.084|0.0210
70939415|NCT02924051|141379538|EQUIVALENCE|With an alpha level of .05 and effective (post-attrition) sample size of approximately 25 participants per county, and 3 counties per treatment group, the power of the group comparison was at least 80%, assuming an ICC of .01 or less, and an observed difference in proportions of .25. The anticipated power for the longitudinal comparison of continuous outcomes was expected to be even greater under these assumptions given the greater power for the parametric tests.|Mean Difference (Final Values)|1.12||||0.26|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.26
71071377|NCT02612610|141651686|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7238|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.7238
71071378|NCT02612610|141651686|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0144|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0144
71071379|NCT02612610|141651686|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0922|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0922
71071380|NCT02612610|141651686|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3812|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3812
71071381|NCT02612610|141651686|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0088|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0088
71114134|NCT00744380|141736312|SUPERIORITY_OR_OTHER|||||||0.75|||||||Chi-squared, Corrected|||For Riker scores||||0.75
71114135|NCT00744380|141736312|SUPERIORITY_OR_OTHER|||||||0.17|||||||Chi-squared|||For pain scores||||0.17
71114136|NCT00744380|141736313|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Chi-squared, Corrected|||For hypotension||||>0.1
71114137|NCT00744380|141736313|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Chi-squared, Corrected|||For bradycardia||||>0.1
71114138|NCT00744380|141736313|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Fisher Exact|||For tachycardia||||>0.1
71114139|NCT00744380|141736313|SUPERIORITY_OR_OTHER|||||||0.07|||||||Fisher Exact|||For delirium, new onset||||0.07
70939416|NCT02924051|141379540|SUPERIORITY|||||||0.36|||||||t-test, 1 sided|||Comparison of Cooking Skills/Nutrition Education/MI at baseline and 12 months.||||0.36
71071382|NCT02612610|141651686|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0653|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0653
71071383|NCT02612610|141651686|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6443|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.6443
71114140|NCT00744380|141736314|SUPERIORITY_OR_OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||Median number of experiences remembered||||0.015
71114141|NCT00744380|141736315|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
71114142|NCT00744380|141736316|SUPERIORITY_OR_OTHER|||||||0.029|||||||t-test, 2 sided|||||||0.029
71114143|NCT00744380|141736317|SUPERIORITY_OR_OTHER||||||>|0.1|||||||t-test, 2 sided|||For anxiety||||>0.1
71114144|NCT00744380|141736317|SUPERIORITY_OR_OTHER||||||>|0.1|||||||t-test, 2 sided|||For depression||||>0.1
71114145|NCT02443116|141736318|SUPERIORITY||Difference in least squares means|-8.84|STANDARD_ERROR_OF_MEAN|1.37|<|0.001|TWO_SIDED|96.0|-12.09|-5.59||p-values are adjusted using a stepdown-Bonferroni method to adjust for multiple testing.|t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||-5.59|-12.09|<0.001
70939417|NCT00828178|141379541|SUPERIORITY_OR_OTHER|||||||0.87|||||||t-test, 2 sided|||Statistical analysis system (SAS) software was used (SAS Institute Inc. Cary, North Carolina, SAS 9.2). Baseline demographic and clinical characteristics were summarized using appropriate descriptive statistics and compared across treatment groups using Chi-square. Two-sample t tests were used in the statistical analysis of the FMD outcomes. ANCOVA was used to compare the groups with respect to changes in clinical variables adjusting for baseline values.||||0.87
71114146|NCT02443116|141736318|SUPERIORITY||Difference in least squares means|-11.06|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|96.0|-14.39|-7.74||p-values are adjusted using a stepdown-Bonferroni method to adjust for multiple testing.|t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||-7.74|-14.39|<0.001
71114147|NCT02443116|141736318|SUPERIORITY||Difference in least squares means|-2.22|STANDARD_ERROR_OF_MEAN|1.38||0.112|TWO_SIDED|96.0|-5.11|0.67|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||0.67|-5.11|0.112
71114148|NCT02443116|141736319|SUPERIORITY||Difference in least squares means|-5.73|STANDARD_ERROR_OF_MEAN|1.38|<|0.0001|TWO_SIDED|95.0|-8.48|-2.99|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||-2.99|-8.48|<0.0001
71114149|NCT02443116|141736319|SUPERIORITY||Difference in least squares means|-6.6|STANDARD_ERROR_OF_MEAN|1.41|<|0.0001|TWO_SIDED|95.0|-9.41|-3.79|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||-3.79|-9.41|<0.0001
71114150|NCT02443116|141736319|SUPERIORITY||Difference in least squares means|-0.87|STANDARD_ERROR_OF_MEAN|1.43||0.5467|TWO_SIDED|95.0|-3.71|1.98|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||1.98|-3.71|0.5467
71114151|NCT02443116|141736319|SUPERIORITY||Difference in least squares means|-5.9|STANDARD_ERROR_OF_MEAN|1.33|<|0.0001|TWO_SIDED|95.0|-8.55|-3.25|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||-3.25|-8.55|<0.0001
71114152|NCT02443116|141736319|SUPERIORITY||Difference in least squares means|-0.17|STANDARD_ERROR_OF_MEAN|1.37||0.9037|TWO_SIDED|95.0|-2.89|2.55|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||2.55|-2.89|0.9037
71114153|NCT02443116|141736319|SUPERIORITY||Difference in least squares means|0.7|STANDARD_ERROR_OF_MEAN|1.38||0.6134|TWO_SIDED|95.0|-2.05|3.45|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||3.45|-2.05|0.6134
71114154|NCT02443116|141736320|SUPERIORITY||Difference in least squares means|-4.97|STANDARD_ERROR_OF_MEAN|1.53||0.0018|TWO_SIDED|95.0|-8.03|-1.91|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||-1.91|-8.03|0.0018
71114155|NCT01932372|141736327|OTHER||Incidence rate ratio (unadjusted)|4.85|||||TWO_SIDED|95.0|3.34|7.03||||||||7.03|3.34|
70852904|NCT03745820|141194621|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.655|=|0.9079|TWO_SIDED|95.0|-1.37|1.22||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Negative Symptoms Subscale: Change From Baseline at Week 12||1.22|-1.37|=0.9079
70939418|NCT00828178|141379542|SUPERIORITY_OR_OTHER|||||||0.1801||||||This Statistical Analysis applies category SELENA-SLEDAI|t-test, 2 sided|||||||0.1801
71114156|NCT01932372|141736327|OTHER||Hazard ratio (unadjusted)|4.8|||||TWO_SIDED|95.0|3.31|6.96||||||||6.96|3.31|
71114157|NCT01932372|141736327|OTHER||Hazard ratio (adjusted 1)|2.07|||||TWO_SIDED|95.0|0.95|4.51||||||||4.51|0.95|
71114158|NCT01932372|141736327|OTHER||Hazard ratio (adjusted 2)|3.81|||||TWO_SIDED|95.0|2.24|6.47||||||||6.47|2.24|
71114159|NCT01932372|141736327|OTHER||Hazard ratio (adjusted 3)|3.55|||||TWO_SIDED|95.0|2.08|6.09||||||||6.09|2.08|
71114160|NCT01932372|141736327|OTHER||Hazard ratio (adjusted 4)|3.8|||||TWO_SIDED|95.0|2.31|6.25||||||||6.25|2.31|
70939419|NCT03005106|141379544|OTHER|Difference between treatment and control sites|Mean Difference (Final Values)|97.77|||<|0.0001|TWO_SIDED|||||Difference is (percent area of Autograft treatment site requiring autografting by Month 3) - (percent area of StrataGraft treatment site requiring autografting by Month 3).|one-sided Wilcoxin Signed RankTtest|||||||<0.0001
70939420|NCT03005106|141379545|OTHER||Percentage of participants|83.1|||||TWO_SIDED|95.0|74.4|91.8|||||95% confidence interval is derived using the normal approximation to the binomial distribution|||91.8|74.4|
71114161|NCT01932372|141736328|OTHER||Incidence rate ratio (unadjusted)|1.6|||||TWO_SIDED|95.0|1.16|2.19||||||||2.19|1.16|
71114162|NCT01932372|141736328|OTHER||Hazard ratio (unadjusted)|1.55|||||TWO_SIDED|95.0|1.12|2.13||||||||2.13|1.12|
71114163|NCT01932372|141736328|OTHER||Hazard ratio (adjusted 1)|1.86|||||TWO_SIDED|95.0|1.16|2.99||||||||2.99|1.16|
71114164|NCT01932372|141736328|OTHER||Hazard ratio (adjusted 2)|1.61|||||TWO_SIDED|95.0|1.06|2.43||||||||2.43|1.06|
71114165|NCT01932372|141736328|OTHER||Hazard ratio (adjusted 3)|1.53|||||TWO_SIDED|95.0|1.0|2.35||||||||2.35|1.00|
71114166|NCT01932372|141736328|OTHER||Hazard ratio (adjusted 4)|1.51|||||TWO_SIDED|95.0|1.03|2.22||||||||2.22|1.03|
71114167|NCT01932372|141736329|OTHER||Mortality rate ratio (unadjusted)|3.39|||||TWO_SIDED|95.0|1.99|5.78||||||||5.78|1.99|
70939421|NCT03005106|141379546|OTHER|Difference is Autograft - StrataGraft|Mean Difference (Final Values)|2.4|||<|0.0001|TWO_SIDED||||||1-sided, paired t-test|p-value from 1-sided, paired t-test on the mean difference(Autograft - StrataGraft)||||||<0.0001
71071384|NCT02612610|141651686|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1511|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1511
71071385|NCT02612610|141651687|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0045|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0045
71071386|NCT02612610|141651687|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0947|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0947
71071387|NCT02612610|141651687|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0080
71071388|NCT02612610|141651687|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0283|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0283
71114168|NCT01932372|141736329|OTHER||Hazard ratio (unadjusted)|3.29|||||TWO_SIDED|95.0|1.93|5.61||||||||5.61|1.93|
71114169|NCT00810771|141736337|SUPERIORITY_OR_OTHER|||||||0.873|TWO_SIDED||||||Chi-squared|||||||0.873
71114170|NCT00810771|141736338|SUPERIORITY_OR_OTHER|||||||0.671|TWO_SIDED||||||Chi-squared|||||||0.671
71114171|NCT00810771|141736339|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Chi-squared|||||||0.002
71114172|NCT00810771|141736340|SUPERIORITY_OR_OTHER|||||||0.186|TWO_SIDED||||||Chi-squared|||||||0.186
70939422|NCT03005106|141379547|OTHER|Difference is Autograft - StrataGraft|Mean Difference (Final Values)|10.0|||<|0.0001|TWO_SIDED|||||Missing total score data were imputed using a multiple imputation analysis assuming a monotone missing data pattern. A linear regression model with ethnicity, race and age as predictive variables was used in the imputation.|1-sided, paired t-test|p-value from 1-sided, paired t-test on the difference (Autograft - StrataGraft)||||||<0.0001
70941959|NCT03859622|141384223|OTHER|Frequencies and percentages for categorical data.||||||||||||Standard methods are used for the description of data (frequencies and percentages for categorical data)||||Standard methods are used for the description of data (frequencies and percentages for categorical data)|Standard methods are used for the description of data (frequencies and percentages for categorical data)|||
71071389|NCT02612610|141651687|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1493|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1493
71114173|NCT00810771|141736341|SUPERIORITY_OR_OTHER|||||||0.576|TWO_SIDED||||||Chi-squared|||||||0.576
71114174|NCT00810771|141736342|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Chi-squared|||||||0.35
71114175|NCT02059499|141736370|SUPERIORITY|||||||0.1877||||||The threshold for statistical significance was p=0.05.|Cochran-Mantel-Haenszel|||||||0.1877
71114176|NCT02059499|141736371|SUPERIORITY|||||||0.1068||||||A priori threshold for statistical significance was p=0.05.|Cochran-Mantel-Haenszel|||||||0.1068
71114177|NCT02059499|141736372|SUPERIORITY|||||||0.8071||||||The threshold for statistical significance was p=0.05|Cochran-Mantel-Haenszel|||||||0.8071
71114178|NCT02059499|141736373|SUPERIORITY|||||||0.6562||||||The threshold for statistical significance was p=0.05|Cochran-Mantel-Haenszel|||||||0.6562
71114179|NCT02059499|141736374|SUPERIORITY|||||||0.0141||||||The threshold for statistical significance was p=0.05.|Cochran-Mantel-Haenszel|||||||0.0141
71114180|NCT02059499|141736375|SUPERIORITY|||||||0.0141||||||The threshold for statistical significance was p=0.05.|Cochran-Mantel-Haenszel|||||||0.0141
71114181|NCT02059499|141736379|SUPERIORITY|||||||0.1409||||||The threshold for statistical significance was p=0.05|Cochran-Mantel-Haenszel|||||||0.1409
71114182|NCT02059499|141736380|SUPERIORITY|||||||0.0805||||||The threshold for statistical significance was p=0.05|Cochran-Mantel-Haenszel|||||||0.0805
71114183|NCT02059499|141736382|SUPERIORITY|||||||0.5726|||||||Cochran-Mantel-Haenszel|||||||0.5726
70852905|NCT03745820|141194621|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.65|=|0.4441|TWO_SIDED|95.0|-1.78|0.79||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Negative Symptoms Subscale: Change From Baseline at Week 12||0.79|-1.78|=0.4441
70939423|NCT00321672|141379548|SUPERIORITY_OR_OTHER|||||||0.0967||95.0||||All stastical tests of hypotheses were two-sided and at the 5% level of significance.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.||The null hypothesis was that there was no difference between the average percent change in NPRS scores from baseline to weeks 2-12 between the total control and total NGX-4010 groups. The ratio of means between the 30- and 60-minute control group \[1.57 (90% CI: 1.12-2.35)\] was \> than the pre-specified equivalence margin ratio of 80-125%. Hence, the control groups could not be pooled and comparisons were performed between the 30- and 60-minute NGX-4010 groups and their respective control groups.||||0.0967
70939424|NCT00321672|141379548|SUPERIORITY_OR_OTHER|||||||0.4884||95.0||||All stastical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustment were made.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.||||||0.4884
70939425|NCT00321672|141379548|SUPERIORITY_OR_OTHER|||||||0.1031||95.0||||All stastical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustment were made.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.||||||0.1031
70939426|NCT00321672|141379549|SUPERIORITY_OR_OTHER|||||||0.0831||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.||"The null hypothesis was: There is no difference between the total Control and total NGX-4010 in the absolute change in NPRS scores from Baseline during Weeks 2-12."||||0.0831
71071390|NCT02612610|141651687|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0026|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0026
71071391|NCT02612610|141651687|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0652|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0652
71071392|NCT02612610|141651687|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3601|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3601
71071393|NCT02612610|141651687|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0086|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0086
71071394|NCT02612610|141651688|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3893|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3893
71071395|NCT02612610|141651688|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2803|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.2803
71071396|NCT02612610|141651688|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0427|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0427
71071397|NCT02612610|141651688|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0209|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0209
71114184|NCT02059499|141736383|SUPERIORITY|||||||0.6184||||||The threshold for statistical significance was p=0.05.|Cochran-Mantel-Haenszel|||||||0.6184
71114185|NCT02059499|141736385|EQUIVALENCE|Comparison of mean between count of hrHPV genotypes observed at baseline vs at week 20 in imiquimod arm||||||0.3||||||A priori threshold for interpreting significance : 0.05|Wilcoxon (Mann-Whitney)|||Comparison of number of hrHPV genotypes in each arm observed at baseline vs at week 20 in imiquimod arm||||0.3
71114186|NCT02059499|141736385|EQUIVALENCE|Comparison of mean number of hrHPV genotypes observed at baseline vs at week 20 in 5FU arm||||||0.3||||||A priori threshold to interpret significance: 0.05|Wilcoxon (Mann-Whitney)|||Comparison of the count of hrHPV genotypes observed at baseline vs at week 20 in 5FU arm||||0.3
70939427|NCT00321672|141379549|SUPERIORITY_OR_OTHER|||||||0.468||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustments were made.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.||||||0.4680
70939428|NCT00321672|141379549|SUPERIORITY_OR_OTHER|||||||0.0896||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustments were made.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.||||||0.0896
70939429|NCT00321672|141379550|SUPERIORITY_OR_OTHER|||||||0.0662||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance.|Regression, Logistic|A logistic regression analysis, with the Baseline NPRS score and gender as covariates, was performed.||"The null hypothesis was: There is no difference between the total Control and total NGX-4010 group in the Proportion of Subjects Reaching 30% Decrease in Their Mean Average Pain for the Past 24 Hours NPRS Score From Baseline During Weeks 2 to 12."||||0.0662
71071398|NCT02612610|141651688|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3401|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3401
70852906|NCT03745820|141194621|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|2.017|=|0.5537|TWO_SIDED|95.0|-5.18|2.79||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Total Score: Change From Baseline at Week 12||2.79|-5.18|=0.5537
71071399|NCT02612610|141651688|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0031|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0031
71071400|NCT02612610|141651688|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0283|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0283
71071401|NCT02612610|141651688|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6233|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.6233
71071402|NCT02612610|141651688|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0001
71071403|NCT02612610|141651689|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4925|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.4925
71071404|NCT02612610|141651689|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9007|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.9007
71071405|NCT02612610|141651689|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1602|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1602
71071406|NCT02612610|141651689|SUPERIORITY_OR_OTHER_LEGACY|||||||0.344|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3440
70939430|NCT00321672|141379550|SUPERIORITY_OR_OTHER|||||||0.5582||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustments were made.|Regression, Logistic|A logistic regression analysis, with the Baseline NPRS score and gender as covariates, was performed.||||||0.5582
70939431|NCT00321672|141379550|SUPERIORITY_OR_OTHER|||||||0.0553||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustments were made.|Regression, Logistic|A logistic regression analysis, with the Baseline NPRS score and gender as covariates, was performed.||||||0.0553
70939432|NCT03163472|141379551|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70939433|NCT03163472|141379552|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
70939434|NCT03163472|141379553|OTHER|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||||||0.022
70939435|NCT03163472|141379554|OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
70939436|NCT00635609|141379562|SUPERIORITY_OR_OTHER|||||||0.765||95.0|||||Cochran-Mantel-Haenszel|Stratified on investigational site.||Study not adequately powered to detect differences in efficacy outcomes. Results to provide estimates of safety and efficacy outcomes.||||0.765
70939437|NCT00635609|141379563|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Cochran-Mantel-Haenszel|Stratified on investigational site.||Study not adequately powered to detect differences in efficacy outcomes. Results to provide estimates of safety and efficacy outcomes.||||0.290
70939438|NCT00635609|141379564|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Cochran-Mantel-Haenszel|Stratified on investigational site||Study not adequately powered to detect differences in efficacy outcomes. Results to provide estimates of safety and efficacy outcomes.||||0.033
70939439|NCT06091982|141379583|SUPERIORITY||Odds Ratio (OR)|10.6|||<|0.0001|TWO_SIDED|95.0|7.0|16.2|||Chi-squared|||Bivariable analysis of both groups||16.2|7.0|<0.0001
70939440|NCT06091982|141379583|OTHER|Multiple logistic regression|Odds Ratio, log|3.4|||<|0.0001|TWO_SIDED|95.0|2.0|6.1|||Regression, Logistic|||Multivariable analysis||6.1|2.0|<0.0001
71071407|NCT02612610|141651689|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9876|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.9876
70939441|NCT06091982|141379584|SUPERIORITY||Odds Ratio (OR)|12.5|||<|0.0001|TWO_SIDED|95.0|9.1|17.1|||Chi-squared|||||17.1|9.1|<0.0001
71071408|NCT02612610|141651689|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0993|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0993
71071409|NCT02612610|141651689|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5968|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.5968
71114187|NCT02059499|141736385|EQUIVALENCE|Comparison of mean number of hrHPV genotypes observed at baseline vs at week 20 in observation arm||||||0.26||||||A priori cutoff of significance: 0.05|Wilcoxon (Mann-Whitney)|||Comparison of the count of hrHPV genotypes observed at baseline vs at week 20 in observation arm||||0.26
71114188|NCT02374060|141736401|SUPERIORITY||Ratio of the proportion of BL|0.79|||<|0.0001|TWO_SIDED|99.87|0.65|0.96||Two sided type I error threshold was 0.00132 since recruitment was halted after the single pre-planned interim analysis|mixed effects model||Ratio of intravitreal over periocular|||.96|.65|<0.0001
70939442|NCT06091982|141379584|SUPERIORITY||Odds Ratio, log|4.4|||<|0.0001|TWO_SIDED|95.0|2.8|7.0|||Regression, Logistic|||||7.0|2.8|<0.0001
70939443|NCT06091982|141379585|SUPERIORITY||Odds Ratio (OR)|15.6|||<|0.0001|TWO_SIDED|95.0|11.3|21.6|||Chi-squared|||||21.6|11.3|<0.0001
70939444|NCT06091982|141379585|OTHER||Odds Ratio, log|5.2|||<|0.0001|TWO_SIDED|95.0|3.3|8.2|||Regression, Logistic|||||8.2|3.3|<0.0001
70939445|NCT03694210|141379687|SUPERIORITY||Mean Difference (Net)|0.0||||0.0011|TWO_SIDED|||||p-values of \<0.05 are considered significant.|Wilcoxon Signed Rank Test|||Physical Functioning: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.0011
70939446|NCT03694210|141379687|SUPERIORITY||Mean Difference (Net)|0.0||||0.1152|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||Role Limitations due to Physical Health: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.1152
70939447|NCT03694210|141379687|SUPERIORITY||Mean Difference (Net)|0.0||||0.0552|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||Role Limitations due to Emotional Problems: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.0552
70939448|NCT03694210|141379687|SUPERIORITY||Mean Difference (Net)|0.0||||0.039|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||Energy/Fatigue: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.039
70939449|NCT03694210|141379687|SUPERIORITY||Mean Difference (Net)|0.0||||0.0223|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||Emotional Well Being: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.0223
70939450|NCT03694210|141379687|SUPERIORITY||Mean Difference (Net)|0.0||||0.4664|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||Social Functioning: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.4664
70939451|NCT03694210|141379687|SUPERIORITY||Mean Difference (Net)|0.0||||0.0001|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||Pain: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.0001
70939452|NCT03694210|141379687|SUPERIORITY||Mean Difference (Net)|0.0||||0.0639|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||General Health: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.0639
70939453|NCT03050372|141379688|EQUIVALENCE|Significance level alpha=0.05; CI=95%.||||||0.329|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SOL for active/sham LFMS are equal; Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline SOL for active/sham LFMS are equal Ha: Means differ"||||0.329
70939454|NCT03050372|141379688|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.321|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SOL for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SOL for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.321
70939455|NCT03050372|141379688|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.687|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SOL for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SOL for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.687
70939456|NCT03050372|141379689|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.925|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of WASO for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline WASO for active/sham LFMS are equal Ha: Means differ"||||0.925
70939457|NCT03050372|141379689|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.08|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of WASO for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline WASO for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.08
70939458|NCT03050372|141379689|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.221|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of WASO for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline WASO for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.221
70939459|NCT03050372|141379690|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.197|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of TST for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline TST for active/sham LFMS are equal Ha: Means differ"||||0.197
70939460|NCT03050372|141379690|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.586|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of TST for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline TST for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.586
70939461|NCT03050372|141379690|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.298|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of TST for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline TST for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.298
71114189|NCT02374060|141736401|SUPERIORITY||Ratio of the proportion of BL|0.69|||<|0.0001|TWO_SIDED|99.87|0.56|0.86||the 2 sided type 1 error threshold was 0.000132 since recruitment was halted after the single preplanned interim analysis|mixed effects model||ratio of dexamethasone over periocular|||0.86|0.56|<0.0001
71114190|NCT02374060|141736401|NON_INFERIORITY|The non inferiority margin was 1.16|Ratio of the proportion of BL|0.88|||||TWO_SIDED|99.87|0.71|1.08|||||A mixed effects model was used to create the confidence interval for testing non-inferiority. The direction is the ratio of dexamethasone over intravitreal|||1.08|.71|
71114191|NCT02374060|141736402|SUPERIORITY||Ratio of the proportion of BL|0.95||||0.35|TWO_SIDED|99.87|0.77|1.16||Two sided type I error threshold was 0.00132 since recruitment was halted after the single Two sided type I error threshold was 0.00132 since recruitment was halted after the single preplanned interim analysis|mixed effects model||Ratio of intravitreal over periocular|||1.16|0.77|0.35
71114192|NCT02374060|141736402|SUPERIORITY||Ratio of the proportion of BL|0.89||||0.07|TWO_SIDED|99.87|0.72|1.1||the 2 sided type 1 error threshold was 0.000132 since recruitment was halted after the single preplanned interim analysis|mixed effects model||ratio of dexamethasone over periocular|||1.10|0.72|0.07
71114193|NCT02374060|141736402|NON_INFERIORITY|The non inferiority margin was 1.16|Ratio of the proportion of BL|0.94|||||TWO_SIDED|99.87|0.77|1.16|||||A mixed effects model was used to create the confidence interval for testing non-inferiority. The direction is the ratio of dexamethasone over intravitreal|||1.16|0.77|
70939462|NCT03050372|141379691|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.424|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SE for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline SE for active/sham LFMS are equal Ha: Means differ"||||0.424
71114194|NCT02374060|141736403|SUPERIORITY||Difference in proportion|0.39|||<|0.0001|TWO_SIDED|95.0|0.24|0.53|||mixed effects model||Intravitreal - periocular|||0.53|0.24|<0.0001
71114195|NCT02374060|141736403|SUPERIORITY||Difference in proportion|0.44|||<|0.0001|TWO_SIDED|95.0|0.29|0.59|||mixed effects model||Dexamethasone - periocular|||0.59|0.29|<0.0001
71114196|NCT02374060|141736403|SUPERIORITY||Difference in proportion|0.05||||0.45|TWO_SIDED|95.0|-0.09|0.19|||mixed effects model||Dexamethasone - intravitreal|||0.19|-0.09|0.45
71114197|NCT02374060|141736404|SUPERIORITY||Difference in proportion|0.12||||0.1|TWO_SIDED|95.0|-0.03|0.27|||mixed effects model||Intravitreal - Periocular|||0.27|-0.03|0.10
71114198|NCT02374060|141736404|SUPERIORITY||Difference in proportion|0.12||||0.11|TWO_SIDED|95.0|-0.03|0.28|||mixed effects model||Dexamethasone - Periocular|||0.28|-0.03|0.11
70939463|NCT03050372|141379691|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.21|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SE for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SE for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.210
71114199|NCT02374060|141736404|SUPERIORITY||Difference in proportion|0.002||||0.98|TWO_SIDED|95.0|-0.16|0.16|||mixed effects model||Dexamethasone - Intravitreal|||0.16|-0.16|0.98
71114200|NCT02374060|141736405|SUPERIORITY||Difference in proportion|0.27||||0.0005|TWO_SIDED|95.0|0.11|0.43|||mixed effects model||Intravitreal - periocular|||0.43|0.11|0.0005
71114201|NCT02374060|141736405|SUPERIORITY||Difference in proportion|0.4|||<|0.0001|TWO_SIDED|95.0|0.25|0.56|||mixed effects model||Dexamethasone - periocular|||0.56|0.25|<0.0001
71114202|NCT02374060|141736405|SUPERIORITY||Difference in proportion|0.13||||0.12|TWO_SIDED|95.0|-0.04|0.3|||mixed effects model||Dexamethasone - intravitreal|||0.30|-0.04|0.12
71114203|NCT02374060|141736406|SUPERIORITY||Difference in proportion|0.004||||0.96|TWO_SIDED|95.0|-0.16|0.17|||mixed effects model||Intravitreal - periocular|||0.17|-0.16|0.96
71114204|NCT02374060|141736406|SUPERIORITY||Difference in proportion|0.06||||0.51|TWO_SIDED|95.0|-0.11|0.23|||mixed effects model||Dexamethasone - periocular|||0.23|-0.11|0.51
71114205|NCT02374060|141736406|SUPERIORITY||Difference in proportion|0.05||||0.54|TWO_SIDED|95.0|-0.12|0.22|||mixed effects model||Dexamethasone - intravitreal|||0.22|-0.12|0.54
70939464|NCT03050372|141379691|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.19|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SE for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SE for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.190
70939465|NCT03050372|141379692|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.535|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of EOS for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline EOS for active/sham LFMS are equal Ha: Means differ"||||0.535
70939466|NCT03050372|141379692|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.196|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of EOS for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline EOS for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.196
71114206|NCT02374060|141736407|SUPERIORITY||Difference in mean change from BL|5.32||||0.003|TWO_SIDED|95.0|1.82|8.82|||mixed effects model||Intravitreal - periocular|||8.82|1.82|0.003
71114207|NCT02374060|141736407|SUPERIORITY||Difference in mean change from BL|5.16||||0.004|TWO_SIDED|95.0|1.6|8.72|||mixed effects model||Dexamethasone - periocular|||8.72|1.60|0.004
71114208|NCT02374060|141736407|SUPERIORITY||Difference in mean change from BL|-0.16||||0.93|TWO_SIDED|95.0|-3.67|3.34|||mixed effects model||Dexamethasone - intravitreal|||3.34|-3.67|0.93
71071410|NCT02612610|141651689|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8726|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.8726
71071411|NCT02612610|141651689|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4092|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.4092
71071412|NCT02612610|141651690|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0781|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0781
71071413|NCT02612610|141651690|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7098|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.7098
71071414|NCT02612610|141651690|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0068|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0068
71114209|NCT02374060|141736408|SUPERIORITY||Difference in mean change from BL|5.53||||0.013|TWO_SIDED|95.0|1.14|9.92|||mixed effects model||Intravitreal - periocular|||9.92|1.14|0.013
71114210|NCT02374060|141736408|SUPERIORITY||Difference in mean change from BL|5.14||||0.019|TWO_SIDED|95.0|0.84|9.44|||mixed effects model||Dexamethasone - periocular|||9.44|0.84|0.019
71114211|NCT02374060|141736408|SUPERIORITY||Difference in mean change from BL|-0.4||||0.84|TWO_SIDED|95.0|-4.16|3.37|||mixed effects model||Dexamethasone-intravitreal|||3.37|-4.16|0.84
71114212|NCT02374060|141736412|SUPERIORITY||Hazard Ratio (HR)|0.33||||0.1|TWO_SIDED|95.0|0.09|1.24|||Regression, Cox||Intravitreal/Periocular|||1.24|0.09|0.10
71114213|NCT02374060|141736412|SUPERIORITY||Hazard Ratio (HR)|0.46||||0.2|TWO_SIDED|95.0|0.14|1.5|||Regression, Cox||Dexamethasone/Periocular|||1.50|0.14|0.20
71114214|NCT02374060|141736412|SUPERIORITY||Hazard Ratio (HR)|1.45||||0.62|TWO_SIDED|95.0|0.34|6.26|||Regression, Cox||Dexamethasone/Intravitreal|||6.26|0.34|0.62
71114215|NCT02374060|141736413|SUPERIORITY||Hazard Ratio (HR)|1.92||||0.11|TWO_SIDED|95.0|0.86|4.29|||Regression, Cox||Intravitreal/Periocular|||4.29|0.86|0.11
70939467|NCT03050372|141379692|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.092|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of EOS for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline EOS for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.092
70939468|NCT03050372|141379693|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||1|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SQS for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline SQS for active/sham LFMS are equal Ha: Means differ"||||1.00
70939469|NCT03050372|141379693|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.004|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SQS for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SQS for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.004
71114216|NCT02374060|141736413|SUPERIORITY||Hazard Ratio (HR)|2.85||||0.009|TWO_SIDED|95.0|1.3|6.28|||Regression, Cox||Dexamethasone/Intravitreal|||6.28|1.30|0.009
71114217|NCT02374060|141736413|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.3|TWO_SIDED|95.0|0.72|2.81|||Regression, Cox||Dexamethasone/intravitreal|||2.81|0.72|0.30
71114218|NCT02374060|141736414|SUPERIORITY||Hazard Ratio (HR)|1.83||||0.09|TWO_SIDED|95.0|0.91|3.65|||Regression, Cox||Intravitreal/periocular|||3.65|0.91|0.09
71071415|NCT02612610|141651690|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1284|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1284
71071416|NCT02612610|141651690|SUPERIORITY_OR_OTHER_LEGACY|||||||0.267|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.2670
71071417|NCT02612610|141651690|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0013|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0013
71071418|NCT02612610|141651690|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4343|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.4343
71114219|NCT02374060|141736414|SUPERIORITY||Hazard Ratio (HR)|2.52||||0.007|TWO_SIDED|95.0|1.29|4.91|||Regression, Cox||Dexamethasone/periocular|||4.91|1.29|0.007
71114220|NCT02374060|141736414|SUPERIORITY||Hazard Ratio (HR)|1.32||||0.37|TWO_SIDED|95.0|0.72|2.43|||Regression, Cox||Dexamethasone/intravitreal|||2.43|0.72|0.37
71114221|NCT02374060|141736415|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.92|TWO_SIDED|95.0|0.28|4.01|||Regression, Cox||Intravitreal/Periocular|||4.01|0.28|0.92
70939470|NCT03050372|141379693|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.042|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SQS for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SQS for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.042
71071419|NCT02612610|141651690|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5384|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.5384
71071420|NCT02612610|141651690|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0822|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0822
71114222|NCT02374060|141736415|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.65|TWO_SIDED|95.0|0.16|3.11|||Regression, Cox||Dexamethasone/Periocular|||3.11|0.16|0.65
71114223|NCT02374060|141736415|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.53|TWO_SIDED|95.0|0.16|2.59|||Regression, Cox||Dexamthasone/Intravitreal|||2.59|0.16|0.53
71114224|NCT03304054|141736420|OTHER|||||||0.2196||||||P-value for Wilcoxon-Mann-Whitney Test of Equality of change from baseline distributions between the amifampridine phosphate and placebo treatment groups.|Wilcoxon (Mann-Whitney)|||A Wilcoxon-Mann-Whitney Rank Sum Test of equality of change from baseline distributions between subjects diagnosed with MuSK-MG treated with amifampridine and placebo was conducted.||||0.2196
71114225|NCT03304054|141736421|OTHER|||||||0.3736||||||P-value for Wilcoxon-Mann-Whitney Test of Equality of change from baseline distributions between the amifampridine phosphate and placebo treatment groups.|Wilcoxon (Mann-Whitney)|||A Wilcoxon-Mann-Whitney Rank Sum Test of equality of change from baseline distributions between subjects diagnosed with MuSK-MG treated with amifampridine and placebo was conducted.||||0.3736
71114226|NCT01696994|141736491|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.95|1.04|||Poisson regression|Two-sided. Not adjusted for multiple comparisons. A-priori threshold for significance 0.05.||||1.04|0.95|
71114227|NCT01696994|141736493|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.21|||||TWO_SIDED|95.0|0.99|1.48|||Poisson regression|||||1.48|0.99|
71114228|NCT01696994|141736503|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.91|1.54||Two-sided. Not adjusted for multiple comparisons. A-priori threshold for significance 0.05.|Poisson regression|||||1.54|.91|
71114229|NCT04644276|141736508|SUPERIORITY||Median Difference (Final Values)|-37.0|STANDARD_DEVIATION|102.0||0.8125|TWO_SIDED|95.0|-112.6|140.7|||Wilcoxon Signed-Ranks test||Unit is percent change.|Percent change in leak 100% x (\[Mask with mask adhesive\] - \[Mask without mask adhesive\])/ \[Mask without mask adhesive\]. The comparison between the two arms is captured in the reported percentage change.||140.7|-112.6|0.8125
70941960|NCT01524887|141384228|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|1.4||||0.243||95.0|-1.0|3.9|||Mixed Models Analysis|||||3.9|-1.0|0.243
70852907|NCT03745820|141194621|SUPERIORITY||LS Mean Difference|-1.96|STANDARD_ERROR_OF_MEAN|2.018|=|0.332|TWO_SIDED|95.0|-5.95|2.02||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Total Score: Change From Baseline at Week 12||2.02|-5.95|=0.3320
70852908|NCT03745820|141194622|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.128|=|0.8517|TWO_SIDED|95.0|-0.23|0.28|||MMRM|||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.||0.28|-0.23|=0.8517
71071421|NCT02612610|141651691|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0006
71071422|NCT02612610|141651691|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0223|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0223
71071423|NCT02612610|141651691|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0001
71071424|NCT02612610|141651691|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0165|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0165
71071425|NCT02612610|141651691|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6255|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.6255
71071426|NCT02612610|141651691|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0085|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0085
71071427|NCT02612610|141651691|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0722|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0722
71071428|NCT02612610|141651691|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3577|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3577
71071429|NCT02612610|141651691|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0006
71114230|NCT01951586|141736526|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.5157|TWO_SIDED|95.0|0.81|1.53|||Log Rank|Log rank test stratified by the randomization stratification factors.|"Based on a Cox proportional hazards model stratified by the randomized stratification factors.~Hazard ratio \< 1 favors denosumab."|||1.53|0.81|0.5157
71071430|NCT02612610|141651692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3845|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3845
71114231|NCT01951586|141736527|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3759|||||||Cox propotional hazard model|||The interaction of RANK expression level measured in the cytoplasm (all intensity) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.3759
71071431|NCT02612610|141651692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1177|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1177
70939471|NCT03050372|141379694|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.05|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of #awake for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline #awake for active/sham LFMS are equal Ha: Means differ"||||0.05
71071432|NCT02612610|141651692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0236|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0236
71071433|NCT02612610|141651692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0192|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0192
71071434|NCT02612610|141651692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3301|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3301
71071435|NCT02612610|141651692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0008
71071436|NCT02612610|141651692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0285|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0285
71114232|NCT01951586|141736527|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3666|||||||Cox propotional hazard model|||The interaction of RANK expression level measured in membranes (all intensity) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.3666
71114233|NCT01951586|141736527|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1917|||||||Cox propotional hazard model|||The interaction of RANK expression level total (cytoplasm + membranes; all intensity) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.1917
71114234|NCT01951586|141736527|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3353|||||||Cox propotional hazard model|||The interaction of RANK expression level measured in the cytoplasm (H-score) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.3353
70852909|NCT03745820|141194622|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.128|=|0.9952|TWO_SIDED|95.0|-0.25|0.25|||MMRM|||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.||0.25|-0.25|=0.9952
70939472|NCT03050372|141379694|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.379|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of #awake for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline #awake for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.379
71114235|NCT01951586|141736527|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3179|||||||Cox propotional hazard model|||The interaction of RANK expression level measured in membranes (H-score) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.3179
70939473|NCT03050372|141379694|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.284|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of #awake for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline #awake for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.284
70939474|NCT03050372|141379695|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.226|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Fatigue for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline Fatigue for active/sham LFMS are equal Ha: Means differ"||||0.226
71071437|NCT02612610|141651692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3856|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3856
70852910|NCT00797966|141194647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.6551|TWO_SIDED|95.0|-2.87|1.81|||ANCOVA|||The planned sample size of 120 participants per arm will yield 80% power to detect the treatment effects at a 2-tailed significance level of 0.025. The 0.025 significance level corresponds to the second level of Hochberg's procedure for handling the two primary efficacy comparisons.||1.81|-2.87|0.6551
71071438|NCT02612610|141651692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0001
71071439|NCT02612610|141651693|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2441|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.2441
71071440|NCT02612610|141651693|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5055|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.5055
71071441|NCT02612610|141651693|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1602|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1602
71071442|NCT02612610|141651693|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2721|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.2721
71071443|NCT02612610|141651693|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9763|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.9763
71071444|NCT02612610|141651693|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0993|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0993
71071445|NCT02612610|141651693|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4575|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.4575
71114236|NCT01951586|141736527|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1583|||||||Cox propotional hazard model|||The interaction of RANK expression level total (cytoplasm + membranes; H-score) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.1583
71114237|NCT01951586|141736528|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3946|||||||Cox propotional hazard model|||The interaction of RANKL expression level measured in the cytoplasm (all intensity) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANKL expression level and treatment-by-RANKL expression level interaction stratified by the randomization stratification factors.||||0.3946
70939475|NCT03050372|141379695|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.156|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Fatigue for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline Fatigue for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.156
71114238|NCT01951586|141736528|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3735|||||||Cox propotional hazard model|||The interaction of RANKL expression level measured in the cytoplasm (H-score) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANKL expression level and treatment-by-RANKL expression level interaction stratified by the randomization stratification factors.||||0.3735
71114239|NCT01951586|141736529|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.76||||0.3491|TWO_SIDED|95.0|0.43|1.35|||Regression, Logistic|Logistic regression model adjusted for the randomization stratification factors.|Based on a logistic regression model adjusted for the randomization stratification factors; an odds ratio ≥ 1 favors denosumab.|||1.35|0.43|0.3491
70941961|NCT01524887|141384228|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|1.0||||0.37||95.0|-1.2|3.3|||Mixed Models Analysis|||||3.3|-1.2|0.370
71114240|NCT01951586|141736530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.476|||||||Regression, Logistic|||The interaction of RANK expression level measured in the cytoplasm (all intensity) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.4760
71114241|NCT01951586|141736530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2582|||||||Regression, Logistic|||The interaction of RANK expression level measured in the membranes (all intensity) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.2582
71071446|NCT02612610|141651693|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9706|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.9706
71114242|NCT01951586|141736530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.223|||||||Regression, Logistic|||The interaction of RANK expression level total (cytoplasm + membrane; all intensity) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.2230
71114243|NCT01951586|141736530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4329|||||||Regression, Logistic|||The interaction of RANK expression level measured in the cytoplasm (H-score) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.4329
71071447|NCT02612610|141651693|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3258|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3258
71071448|NCT02612610|141651694|OTHER||LS Mean Difference|0.0||||0.9858|TWO_SIDED|95.0|-0.53|0.54|||Mixed Effect Repeated Measures model|||"Day 28 Sleep Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.54|-0.53|0.9858
71071449|NCT02612610|141651694|OTHER||LS Mean Difference|-0.01||||0.9813|TWO_SIDED|95.0|-0.53|0.52|||Mixed Effect Repeated Measures model|||"Day 28 Sleep Cough Frequency: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.52|-0.53|0.9813
71071450|NCT02612610|141651694|OTHER||LS Mean Difference|-0.11||||0.6746|TWO_SIDED|95.0|-0.65|0.42|||Mixed Effect Repeated Measures model|||"Day 28 Sleep Cough Frequency: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.42|-0.65|0.6746
71071451|NCT02612610|141651695|OTHER||LS Mean Difference|-0.32||||0.2583|TWO_SIDED|95.0|-0.88|0.24|||Mixed Effect Repeated Measures model|||"Day 56 Sleep Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.24|-0.88|0.2583
71071452|NCT02612610|141651695|OTHER||LS Mean Difference|0.01||||0.9826|TWO_SIDED|95.0|-0.55|0.56|||Mixed Effect Repeated Measures model|||"Day 56 Sleep Cough Frequency: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.56|-0.55|0.9826
71114244|NCT01951586|141736530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.262|||||||Regression, Logistic|||The interaction of RANK expression level measured in the membranes (H-score) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.2620
71114245|NCT01951586|141736530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2081|||||||Regression, Logistic|||The interaction of RANK expression level total (cytoplasm + membrane; H-score) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.2081
71114246|NCT01951586|141736531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4671|||||||Regression, Logistic|||The interaction of RANKL expression level measured in the cytoplasm (all intensity) and treatment effect was evaluated using a logistic regression model that included treatment group, RANKL expression level and treatment-by-RANKL expression level interaction stratified by the randomization stratification factors.||||0.4671
71114247|NCT01951586|141736531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4236|||||||Regression, Logistic|||The interaction of RANKL expression level measured in the cytoplasm (H-score) and treatment effect was evaluated using a logistic regression model that included treatment group, RANKL expression level and treatment-by-RANKL expression level interaction stratified by the randomization stratification factors.||||0.4236
71114248|NCT01951586|141736532|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.81||||0.4654|TWO_SIDED|95.0|0.46|1.43|||Regression, Logistic|Logistic regression model adjusted for the randomization stratification factors.|Based on a logistic regression model adjusted for the randomization stratification factors; an odds ratio ≥ 1 favors denosumab.|||1.43|0.46|0.4654
70941962|NCT01524887|141384229|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-3.9||||0.033||95.0|-7.4|-0.3|||Mixed Models Analysis|||||-0.3|-7.4|0.033
71114249|NCT01951586|141736533|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.05||||0.7363|TWO_SIDED|95.0|0.78|1.43|||Log Rank|Log rank test stratified by the randomized stratification factors.|"Based on a Cox proportional hazards model stratified by the randomized stratification factors.~Hazard ratio \< 1 favors denosumab."|||1.43|0.78|0.7363
71114250|NCT01822899|141736576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08|||<|0.001|TWO_SIDED|95.0|0.046|0.113|||ANCOVA|||||0.113|0.046|<0.001
71114251|NCT02752633|141736590|OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Data are presented as the urinary DHA excretion (mg/24 hr) and as the DHA-to-creatinine ratio (mg/mmol) in first morning void urine samples. Data are presented as a median (range). Differences in the median urinary DHA excretion and the urinary DHA-to-creatinine ratio between periods off pharmacotherapy and on the two study drugs, febuxostat and allopurinol, were assessed using the Wilcoxon signed rank test.||||<.05
71114252|NCT00853242|141736608|SUPERIORITY_OR_OTHER|||||||0.0249|TWO_SIDED||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.||||0.0249
71114253|NCT00853242|141736608|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.||||0.0001
71114254|NCT00853242|141736608|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.||||<0.0001
71114255|NCT00853242|141736609|SUPERIORITY_OR_OTHER|||||||0.2647|TWO_SIDED||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.||||0.2647
71114256|NCT00853242|141736609|SUPERIORITY_OR_OTHER|||||||0.7944|TWO_SIDED||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.||||0.7944
71114257|NCT00853242|141736609|SUPERIORITY_OR_OTHER|||||||0.3724|TWO_SIDED||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.||||0.3724
71114258|NCT00842153|141736693|SUPERIORITY_OR_OTHER|||||||0.1269||95.0||||P-value for Week 1|Fisher Exact|||||||0.1269
71114259|NCT00842153|141736693|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for Week 2|Chi-squared|||||||<0.0001
71114260|NCT00842153|141736693|SUPERIORITY_OR_OTHER|||||||0.0015||95.0||||P-value for Week 4|Chi-squared|||||||0.0015
71114261|NCT00002540|141736710|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.87|1.36||Two-sided. Not adjusted for multiple comparisons. A-priori threshold for significance 0.05.|Poisson regression|||||1.36|0.87|
71114262|NCT00002540|141736712|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.93|1.0|||Poisson regression|Two-sided. Not adjusted for multiple comparisons. A-priori threshold for significance 0.05.||||1.00|0.93|
71114263|NCT00002540|141736714|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|1.07|1.17|||Poisson regression|Two-sided. Not adjusted for multiple comparisons. A-priori threshold for significance 0.05.||||1.17|1.07|
71114264|NCT00002540|141736724|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.87|1.36|||Poisson regression|||||1.36|0.87|
70852911|NCT00797966|141194647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.7037|TWO_SIDED|95.0|-2.3|1.55|||ANCOVA|||The planned sample size of 120 participants per arm will yield 80% power to detect the treatment effects at a 2-tailed significance level of 0.025. The 0.025 significance level corresponds to the second level of Hochberg's procedure for handling the two primary efficacy comparisons.||1.55|-2.30|0.7037
71114265|NCT01345929|141736727|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower bound of the 2-sided 95% CI was greater than -10%.|Risk Difference (RD)|8.5|||||TWO_SIDED|95.0|2.31|14.57||||||||14.57|2.31|
71114266|NCT01345929|141736728|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower bound of the 2-sided 95% CI was greater than -10%.|Risk Difference (RD)|8.0|||||TWO_SIDED|95.0|1.95|13.97||||||||13.97|1.95|
71114267|NCT01500252|141736739|SUPERIORITY_OR_OTHER_LEGACY|||||||0.59||95.0|||||t-test, 2 sided|||||||0.59
71114268|NCT01500252|141736740|SUPERIORITY_OR_OTHER_LEGACY|||||||0.83||95.0|||||t-test, 2 sided|||||||0.83
71114269|NCT01500252|141736742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||t-test, 2 sided|||||||0.10
71114270|NCT01500252|141736743|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39||95.0|||||t-test, 2 sided|||||||0.39
71114271|NCT01500252|141736744|SUPERIORITY_OR_OTHER_LEGACY|||||||0.43||95.0|||||t-test, 2 sided|||||||0.43
71114272|NCT01500252|141736745|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71||95.0|||||t-test, 2 sided|||||||0.71
71114273|NCT01500252|141736746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98||95.0|||||t-test, 2 sided|||||||0.98
71114274|NCT01500252|141736747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||95.0|||||t-test, 2 sided|||||||0.35
71114275|NCT01500252|141736748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||95.0|||||Chi-squared|||||||0.31
71114276|NCT05319600|141736749|SUPERIORITY|treatment group as predictor baseline-residualized week 12 scores in linear regression|Slope|129.2|STANDARD_ERROR_OF_MEAN|73.96|<|0.05|TWO_SIDED|95.0|-22.52|280.98|||Regression, Linear||Control coded as 0 and treatment as 1|||280.98|-22.52|<0.05
71114277|NCT00323960|141736750|SUPERIORITY|||||||0.0228||||||For multiple hypothesis testing, we used Bonferroni's correction (with n=3 posterior comparisons).|Chi-squared|To assess proportions we used the χ² test or Fisher's exact test||We calculated that a sample size of 40 patients would be needed in each study group (total 120 patients) to have 80% power for comparison of combination treatments (prednisone plus methotrexate or prednisone plus ciclosporin) with the reference treatment (prednisone alone).||||0.0228
71114278|NCT00323960|141736751|SUPERIORITY||Relative risk|2.45||||0.012|TWO_SIDED|95.0|1.2|5.0|||Log Rank||RR related to prednisone plus methotrexate arm (group 3) versus prednisone alone (group 1) and prednisone plus ciclosporin (group 2).|We used the Kaplan-Meier method to produce survival curves (groups 1 and 2 versus group 3) and compared them with the Log-Rank test. We judged a p value less than 0·05 significant. We reported in the table the incidence rates with 95% confidence intervals of the 3 groups.||5.0|1.2|0.012
71114279|NCT00323960|141736752|SUPERIORITY||Relative risk|1.95||||0.009|TWO_SIDED|95.0|1.2|3.15|||Log Rank||RR related to prednisone alone (group 1) versus prednisone plus ciclosporin (group 2) and prednisone plus methotrexate arm (group 3).|We used the Kaplan-Meier method to produce survival curves (group 1 versus groups 2 and 3) and compared them with the Log-Rank test. We judged a p value less than 0·05 significant. We reported in the table the incidence rates with 95% confidence intervals of the 3 groups.||3.15|1.2|0.009
71114280|NCT00323960|141736753|SUPERIORITY||Relative risk|1.65||||0.002|TWO_SIDED|95.0|1.24|2.14|||Log Rank||RR related to prednisone+methotrexate arm or prednisone+ciclosporin versus prednisone alone.|We used the Kaplan-Meier method to produce survival curves (groups 2 and 3 versus group 1) and compared them with the Log-Rank test. We judged a p value less than 0·05 significant. We reported in the table the incidence rates with 95% confidence intervals of the 3 groups.||2.14|1.24|0.002
71114281|NCT00323960|141736753|SUPERIORITY||Relative risk|1.65||||0.002|TWO_SIDED|95.0|1.24|2.14|||Log Rank||RR related to prednisone alone (group 1) versus prednisone plus ciclosporin (group 2) and prednisone plus methotrexate arm (group 3).|We used the Kaplan-Meier method to produce survival curves (groups 1 versus groups 2 and 3) and compared them with the Log-Rank test. We judged a p value less than 0·05 significant. We reported in the table the incidence rates with 95% confidence intervals of the 3 groups.||2.14|1.24|0.002
71114282|NCT00361231|141736782|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Kaplan-Meier|||||||<0.05
71114283|NCT00361231|141736783|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Kaplan-Meier|||||||0.05
71114284|NCT01208961|141736790|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|400.36|||<|0.001|TWO_SIDED|90.0|326.87|490.36|||ANOVA|ANOVA on log-trans baseline-adj PK values using sequence, period, and treatments as fixed effects and subject nested within sequence as random effect||Results for the analyses of the High-Fat Periods were not posted because the critical comparison was the response of Lovaza versus Epanova to the clinically relevant low-fat diet to be used as adjunct in hypertriglyceridemia.||490.36|326.87|<0.001
71114285|NCT01208961|141736791|SUPERIORITY_OR_OTHER||Ratio of Geometric Mans|649.66|||<|0.01|TWO_SIDED|90.0|511.75|824.75||ANOVA model with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors. LSM estimate performed on log-scale|ANOVA|||Results for the analyses of the High-Fat Periods were not posted because the critical comparison was the response of Lovaza versus Epanova to the clinically relevant low-fat diet to be used as adjunct in hypertriglyceridemia.||824.75|511.75|<0.01
71114286|NCT01208961|141736792|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|369.66|||<|0.001|TWO_SIDED|90.0|301.74|452.86|||ANOVA|||Results for the analyses of the High-Fat Periods were not posted because the critical comparison was the response of Lovaza versus Epanova to the clinically relevant low-fat diet to be used as adjunct in hypertriglyceridemia.||452.86|301.74|<0.001
70852912|NCT00797966|141194647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.14||||0.0303|TWO_SIDED|95.0|-4.08|-0.21|||ANCOVA|||The planned sample size of 120 participants per arm will yield 80% power to detect the treatment effects at a 2-tailed significance level of 0.025. The 0.025 significance level corresponds to the second level of Hochberg's procedure for handling the two primary efficacy comparisons.||-0.21|-4.08|0.0303
71071453|NCT02612610|141651695|OTHER||LS Mean Difference|-0.4||||0.1672|TWO_SIDED|95.0|-0.98|0.17|||Mixed Effect Repeated Measures model|||"Day 56 Sleep Cough Frequency: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.17|-0.98|0.1672
71114287|NCT02241733|141736794|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||An independent t-test was completed.||||0.94
71114288|NCT02241733|141736795|SUPERIORITY|||||||0.078|||||||t-test, 2 sided|||||||0.078
71114289|NCT02241733|141736796|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.80
71114290|NCT02241733|141736797|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||||||0.76
71071454|NCT02612610|141651696|OTHER||LS Mean Difference|0.14||||0.6102|TWO_SIDED|95.0|-0.4|0.68|||Mixed Effect Repeated Measures model|||"Day 84 Sleep Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.68|-0.4|0.6102
71114291|NCT02285023|141736798|NON_INFERIORITY_OR_EQUIVALENCE|Principal component analysis with varimax rotation was employed. An eigenvalue ≥ 1 was chosen as the criterion to retain domains. Each item was classified into the domain when loading with a domain loading ≥ 0.5.|||||<|0.01||||||An eigenvalue ≥ 1 was chosen as the criterion to retain domains. Each item was classified into the domain when loading with a domain loading ≥ 0.5|exploratory factor analysis|An eigenvalue ≥ 1 was chosen as the criterion to retain domains. Each item was classified into the domain when loading with a domain loading ≥ 0.5||Exploratory factor analysis||||<0.01
71114292|NCT02285023|141736799|SUPERIORITY_OR_OTHER||Cronbach's alpha|0.94|||<|0.05|TWO_SIDED||||||Crohbach's alpha|||||||<0.05
71114293|NCT01866111|141736802|SUPERIORITY||||||<|0.001|||||||ANCOVA|||A step down procedure was used for the primary efficacy analyses to ensure the type one error rate for multiple comparisons was controlled at the 5% level using the following hierarchy: 200 mg vs placebo, 400 mg vs placebo, 100 mg vs placebo, in which a statistically significant difference had to be detected in this order for each subsequent comparison to occur.||||<0.001
71114294|NCT01866111|141736802|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
71114295|NCT01866111|141736802|SUPERIORITY|||||||0.007|||||||ANCOVA|||||||0.007
71114296|NCT01866111|141736803|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71071455|NCT02612610|141651696|OTHER||LS Mean Difference|0.08||||0.7782|TWO_SIDED|95.0|-0.46|0.61|||Mixed Effect Repeated Measures model|||"Day 84 Sleep Cough Frequency: 20 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.61|-0.46|0.7782
71114297|NCT01866111|141736803|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71114298|NCT01866111|141736803|SUPERIORITY|||||||0.003|||||||Fisher Exact|||||||0.003
71114299|NCT04576455|141736806|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.1757|TWO_SIDED|95.0|0.6|1.1|||Log Rank|Stratified analysis (strata are: site of disease, prior CDK4/6i treatment, and prior fulvestrant treatment).|Giredestrant vs. PCET|||1.10|0.60|0.1757
70852913|NCT00797966|141194648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.4166|TWO_SIDED|95.0|-0.43|0.18|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo|||0.18|-0.43|0.4166
70939476|NCT03050372|141379695|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.117|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Fatigue for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline Fatigue for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.117
70852914|NCT00797966|141194648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.4193|TWO_SIDED|95.0|-0.35|0.15|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||0.15|-0.35|0.4193
71071456|NCT02612610|141651696|OTHER||LS Mean Difference|0.28||||0.3167|TWO_SIDED|95.0|-0.27|0.83|||Mixed Effect Repeated Measures model|||"Day 84 Sleep Cough Frequency: 50 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.83|-0.27|0.3167
71071457|NCT02612610|141651697|OTHER||LS Mean Difference|0.3||||0.1545|TWO_SIDED|95.0|-0.1|0.7|||Mixed Effect Repeated Measures model|||"Week 1 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.7|-0.1|0.1545
71071458|NCT02612610|141651697|OTHER||LS Mean Difference|0.3||||0.2013|TWO_SIDED|95.0|-0.1|0.7|||Mixed Effect Repeated Measures model|||"Week 1 CSD Total Score: 20 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.7|-0.1|0.2013
71071459|NCT02612610|141651697|OTHER||LS Mean Difference|0.0||||0.9962|TWO_SIDED|95.0|-0.4|0.4|||Mixed Effect Repeated Measures model|||"Week 1 CSD Total Score: 50 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.4|0.9962
71071460|NCT02612610|141651698|OTHER||LS Mean Difference|0.1||||0.7328|TWO_SIDED|95.0|-0.4|0.6|||Mixed Effect Repeated Measures model|||"Week 2 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.6|-0.4|0.7328
71071461|NCT02612610|141651698|OTHER||LS Mean Difference|0.1||||0.7635|TWO_SIDED|95.0|-0.4|0.6|||Mixed Effect Repeated Measures model|||"Week 2 CSD Total Score: 20 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.6|-0.4|0.7635
71071462|NCT02612610|141651698|OTHER||LS Mean Difference|-0.4||||0.0951|TWO_SIDED|95.0|-0.9|0.1|||Mixed Effect Repeated Measures model|||"Week 2 CSD Total Score: 50 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-0.9|0.0951
71071463|NCT02612610|141651699|OTHER||LS Mean Difference|-0.2||||0.5797|TWO_SIDED|95.0|-0.7|0.4|||Mixed Effect Repeated Measures model|||"Week 3 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.7|0.5797
71071464|NCT02612610|141651699|OTHER||LS Mean Difference|-0.3||||0.2499|TWO_SIDED|95.0|-0.9|0.2|||Mixed Effect Repeated Measures model|||"Week 3 CSD Total Score: 20 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-0.9|0.2499
71071465|NCT02612610|141651699|OTHER||LS Mean Difference|-0.5||||0.0612|TWO_SIDED|95.0|-1.1|0.0|||Mixed Effect Repeated Measures model|||"Week 3 CSD Total Score: 50 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.0|-1.1|0.0612
71071466|NCT02612610|141651700|OTHER||LS Mean Difference|-0.2||||0.5358|TWO_SIDED|95.0|-0.7|0.4|||Mixed Effect Repeated Measures model|||"Week 4 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.7|0.5358
71114300|NCT04576455|141736807|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.3446|TWO_SIDED|95.0|0.85|1.6|||Log Rank|Stratified analysis (strata are: site of disease, prior CDK4/6i treatment, and prior fulvestrant treatment).|Giredestrant vs. PCET|||1.60|0.85|0.3446
71114301|NCT04576455|141736808|SUPERIORITY||Odds Ratio (OR)|1.87||||0.1126|TWO_SIDED|95.0|0.86|4.07|||Cochran-Mantel-Haenszel||Giredestrant vs. PCET|||4.07|0.86|0.1126
71114302|NCT04576455|141736808|SUPERIORITY||Difference in Objective Response Rates|5.35|||||TWO_SIDED|95.0|-1.97|12.78|||||Giredestrant vs. PCET|||12.78|-1.97|
71114303|NCT04576455|141736810|SUPERIORITY||Odds Ratio (OR)|1.79||||0.0289|TWO_SIDED|95.0|1.06|3.04|||Cochran-Mantel-Haenszel||Giredestrant vs. PCET|||3.04|1.06|0.0289
71071467|NCT02612610|141651700|OTHER||LS Mean Difference|-0.3||||0.3129|TWO_SIDED|95.0|-0.8|0.3|||Mixed Effect Repeated Measures model|||"Week 4 CSD Total Score: 20 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-0.8|0.3129
71114304|NCT04576455|141736810|SUPERIORITY||Difference in Clinical Benefit Rates|10.74|||||TWO_SIDED|95.0|0.33|20.86|||||Giredestrant vs. PCET|||20.86|0.33|
70939477|NCT03050372|141379696|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.13|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Concentration for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline Concentration for active/sham LFMS are equal Ha: Means differ"||||0.130
70939478|NCT03050372|141379696|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.249|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Concentration for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline Concentration for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.249
70939479|NCT03050372|141379696|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.114|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Concentration for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline Concentration for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.114
70939480|NCT01375777|141379698|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.23|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-54.52|-39.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-39.93|-54.52|<0.001
70939481|NCT01375777|141379698|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.17|STANDARD_ERROR_OF_MEAN|3.66|<|0.001||95.0|-47.38|-32.95||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-32.95|-47.38|<0.001
71071468|NCT02612610|141651700|OTHER||LS Mean Difference|-0.5||||0.1046|TWO_SIDED|95.0|-1.0|0.1|||Mixed Effect Repeated Measures model|||"Week 4 CSD Total Score: 50 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.0|0.1046
71071469|NCT02612610|141651701|OTHER||LS Mean Difference|-0.2||||0.5796|TWO_SIDED|95.0|-0.7|0.4|||Mixed Effect Repeated Measures model|||"Week 5 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.7|0.5796
71071470|NCT02612610|141651701|OTHER||LS Mean Difference|-0.4||||0.143|TWO_SIDED|95.0|-1.0|0.1|||Mixed Effect Repeated Measures model|||"Week 5 CSD Total Score: 20 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.0|0.1430
71071471|NCT02612610|141651701|OTHER||LS Mean Difference|-0.7||||0.0221|TWO_SIDED|95.0|-1.2|-0.1|||Mixed Effect Repeated Measures model|||"Week 5 CSD Total Score: 50 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-0.1|-1.2|0.0221
71071472|NCT02612610|141651702|OTHER||LS Mean Difference|-0.4||||0.1562|TWO_SIDED|95.0|-1.0|0.2|||Mixed Effect Repeated Measures model|||"Week 6 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-1.0|0.1562
71071473|NCT02612610|141651702|OTHER||LS Mean Difference|-0.5||||0.071|TWO_SIDED|95.0|-1.1|0.0|||Mixed Effect Repeated Measures model|||"Week 6 CSD Total Score: 20 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.0|-1.1|0.0710
71071474|NCT02612610|141651702|OTHER||LS Mean Difference|-0.7||||0.0274|TWO_SIDED|95.0|-1.2|-0.1|||Mixed Effect Repeated Measures model|||"Week 6 CSD Total Score: 50 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-0.1|-1.2|0.0274
71114305|NCT04576455|141736811|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.061|TWO_SIDED|95.0|0.35|1.03|||Log Rank|Stratified analysis (strata are: site of disease, prior CDK4/6i treatment, and prior fulvestrant treatment).|Giredestrant vs. PCET|This statistical analysis is done for PFS by ESR1 mutation detected at baseline||1.03|0.35|0.0610
70941963|NCT01524887|141384229|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.9||||0.586||95.0|-4.2|2.4|||Mixed Models Analysis|||||2.4|-4.2|0.586
71071475|NCT02612610|141651703|OTHER||LS Mean Difference|-0.2||||0.4464|TWO_SIDED|95.0|-0.8|0.4|||Mixed Effect Repeated Measures model|||"Week 7 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.8|0.4464
71071476|NCT02612610|141651703|OTHER||LS Mean Difference|-0.3||||0.332|TWO_SIDED|95.0|-0.9|0.3|||Mixed Effect Repeated Measures model|||"Week 7 CSD Total Score: 20 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-0.9|0.3320
71114306|NCT04576455|141736811|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.5947|TWO_SIDED|95.0|0.54|1.42|||Log Rank|Stratified analysis (strata are: site of disease, prior CDK4/6i treatment, and prior fulvestrant treatment).|Giredestrant vs. PCET|This statistical analysis is done for PFS by ESR1 Mutation not detected at baseline||1.42|0.54|0.5947
70939482|NCT01375777|141379698|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.27|STANDARD_ERROR_OF_MEAN|3.68|<|0.001|TWO_SIDED|95.0|-44.53|-30.02||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-30.02|-44.53|<0.001
70939483|NCT01375777|141379698|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.53|STANDARD_ERROR_OF_MEAN|3.62|<|0.001|TWO_SIDED|95.0|-59.67|-45.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-45.38|-59.67|<0.001
70939484|NCT01375777|141379698|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.74|STANDARD_ERROR_OF_MEAN|3.62|<|0.001|TWO_SIDED|95.0|-54.89|-40.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-40.60|-54.89|<0.001
70939485|NCT01375777|141379698|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.57|STANDARD_ERROR_OF_MEAN|3.62|<|0.001|TWO_SIDED|95.0|-50.71|-36.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-36.42|-50.71|<0.001
70941964|NCT01524887|141384230|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.2||||0.501||95.0|-1.0|0.5|||Mixed Models Analysis|||||0.5|-1.0|0.501
71071477|NCT02612610|141651703|OTHER||LS Mean Difference|-0.5||||0.0792|TWO_SIDED|95.0|-1.1|0.1|||Mixed Effect Repeated Measures model|||"Week 7 CSD Total Score: 50 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.1|0.0792
71071478|NCT02612610|141651704|OTHER||LS Mean Difference|-0.2||||0.4716|TWO_SIDED|95.0|-0.8|0.4|||Mixed Effect Repeated Measures model|||"Week 8 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.8|0.4716
71071479|NCT02612610|141651704|OTHER||LS Mean Difference|-0.2||||0.4371|TWO_SIDED|95.0|-0.8|0.4|||Mixed Effect Repeated Measures model|||"Week 8 CSD Total Score: 20 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.8|0.4371
71071480|NCT02612610|141651704|OTHER||LS Mean Difference|-0.4||||0.1907|TWO_SIDED|95.0|-1.0|0.2|||Mixed Effect Repeated Measures model|||"Week 8 CSD Total Score: 50 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-1.0|0.1907
71071481|NCT02612610|141651705|OTHER||LS Mean Difference|-0.3||||0.2772|TWO_SIDED|95.0|-0.9|0.3|||Mixed Effect Repeated Measures model|||"Week 9 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-0.9|0.2772
71071482|NCT02612610|141651705|OTHER||LS Mean Difference|-0.5||||0.1132|TWO_SIDED|95.0|-1.1|0.1|||Mixed Effect Repeated Measures model|||"Week 9 CSD Total Score: 20 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.1|0.1132
71071483|NCT02612610|141651705|OTHER||LS Mean Difference|-0.6||||0.0737|TWO_SIDED|95.0|-1.2|0.1|||Mixed Effect Repeated Measures model|||"Week 9 CSD Total Score: 50 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.2|0.0737
71071484|NCT02612610|141651706|OTHER||LS Mean Difference|-0.1||||0.6266|TWO_SIDED|95.0|-0.8|0.5|||Mixed Effect Repeated Measures model|||"Week 10 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.5|-0.8|0.6266
71114307|NCT04576455|141736812|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.58|1.4|||||Giredestrant vs. PCET|||1.40|0.58|
71114308|NCT04576455|141736813|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.49|1.12|||||Giredestrant vs. PCET|||1.12|0.49|
71114309|NCT04576455|141736814|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.53|1.35|||||Giredestrant vs. PCET|||1.35|0.53|
71114310|NCT04576455|141736815|OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.72|1.69|||||Giredestrant vs. PCET|||1.69|0.72|
71114311|NCT04576455|141736816|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.47|1.18|||||Giredestrant vs. PCET|||1.18|0.47|
71114312|NCT03989349|141736822|OTHER||Strata-adjusted percentage difference|12.2||||0.0006|TWO_SIDED|97.5|4.6|19.8||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||19.8|4.6|0.0006
71071485|NCT02612610|141651706|OTHER||LS Mean Difference|-0.4||||0.1769|TWO_SIDED|95.0|-1.0|0.2|||Mixed Effect Repeated Measures model|||"Week 10 CSD Total Score: 20 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-1.0|0.1769
71071486|NCT02612610|141651706|OTHER||LS Mean Difference|-0.7||||0.0313|TWO_SIDED|95.0|-1.3|-0.1|||Mixed Effect Repeated Measures model|||"Week 10 CSD Total Score: 50 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-0.1|-1.3|0.0313
71071487|NCT02612610|141651707|OTHER||LS Mean Difference|-0.4||||0.2058|TWO_SIDED|95.0|-1.0|0.2|||Mixed Effect Repeated Measures model|||"Week 11 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-1.0|0.2058
71071488|NCT02612610|141651707|OTHER||LS Mean Difference|-0.6||||0.0665|TWO_SIDED|95.0|-1.2|0.0|||Mixed Effect Repeated Measures model|||"Week 11 CSD Total Score: 20 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.0|-1.2|0.0665
71071489|NCT02612610|141651707|OTHER||LS Mean Difference|-0.8||||0.0155|TWO_SIDED|95.0|-1.4|-0.1|||Mixed Effect Repeated Measures model|||"Week 11 CSD Total Score: 50 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-0.1|-1.4|0.0155
71071490|NCT02612610|141651708|OTHER||LS Mean Difference|-0.4||||0.2458|TWO_SIDED|95.0|-1.0|0.3|||Mixed Effect Repeated Measures model|||"Week 12 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-1.0|0.2458
71071491|NCT02612610|141651708|OTHER||LS Mean Difference|-0.6||||0.0662|TWO_SIDED|95.0|-1.2|0.0|||Mixed Effect Repeated Measures model|||"Week 12 CSD Total Score: 20 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.0|-1.2|0.0662
71071492|NCT02612610|141651708|OTHER||LS Mean Difference|-0.7||||0.0197|TWO_SIDED|95.0|-1.4|-0.1|||Mixed Effect Repeated Measures model|||"Week 12 CSD Total Score: 50 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-0.1|-1.4|0.0197
71071493|NCT02612610|141651709|OTHER||LS Mean Difference|0.3||||0.1921|TWO_SIDED|95.0|-0.2|0.8|||Mixed Effect Repeated Measures model|||"Week 1 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.8|-0.2|0.1921
71114313|NCT03989349|141736823|OTHER||Strata-adjusted percentage difference|14.9||||0.0008|TWO_SIDED|97.5|5.6|24.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||24.3|5.6|0.0008
71114314|NCT03989349|141736824|OTHER||Strata-adjusted percentage difference|12.5||||0.0006|TWO_SIDED|97.5|4.6|20.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||20.3|4.6|0.0006
71071494|NCT02612610|141651709|OTHER||LS Mean Difference|0.3||||0.2428|TWO_SIDED|95.0|-0.2|0.8|||Mixed Effect Repeated Measures model|||"Week 1 DCS Total Score: 20 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.8|-0.2|0.2428
71071495|NCT02612610|141651709|OTHER||LS Mean Difference|-0.1||||0.7383|TWO_SIDED|95.0|-0.6|0.4|||Mixed Effect Repeated Measures model|||"Week 1 DCS Total Score: 50 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.6|0.7383
71071496|NCT02612610|141651710|OTHER||LS Mean Difference|0.3||||0.4033|TWO_SIDED|95.0|-0.4|0.9|||Mixed Effect Repeated Measures model|||"Week 2 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.9|-0.4|0.4033
71071497|NCT02612610|141651710|OTHER||LS Mean Difference|0.2||||0.4599|TWO_SIDED|95.0|-0.4|0.9|||Mixed Effect Repeated Measures model|||"Week 2 DCS Total Score: 20 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.9|-0.4|0.4599
70939486|NCT01375777|141379699|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-65.9|STANDARD_ERROR_OF_MEAN|5.2|<|0.001|TWO_SIDED|95.0|-76.3|-55.6||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-55.6|-76.3|<0.001
70939487|NCT01375777|141379699|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-62.7|STANDARD_ERROR_OF_MEAN|5.3|<|0.001||95.0|-73.2|-52.2||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-52.2|-73.2|<0.001
70939488|NCT01375777|141379699|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.3|STANDARD_ERROR_OF_MEAN|5.3|<|0.001|TWO_SIDED|95.0|-62.7|-41.9||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-41.9|-62.7|<0.001
70939489|NCT01375777|141379699|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-72.3|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-82.2|-62.4||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-62.4|-82.2|<0.001
70939490|NCT01375777|141379699|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-63.9|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-73.9|-54.0||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-54.0|-73.9|<0.001
70939491|NCT01375777|141379699|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.8|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-70.7|-50.9||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-50.9|-70.7|<0.001
70939492|NCT01375777|141379700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.15|STANDARD_ERROR_OF_MEAN|3.33|<|0.001|TWO_SIDED|95.0|-51.72|-38.58||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-38.58|-51.72|<0.001
70939493|NCT01375777|141379700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.79|STANDARD_ERROR_OF_MEAN|3.29|<|0.001||95.0|-43.29|-30.29||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-30.29|-43.29|<0.001
70939494|NCT01375777|141379700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.06|STANDARD_ERROR_OF_MEAN|3.31|<|0.001|TWO_SIDED|95.0|-41.59|-28.52||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-28.52|-41.59|<0.001
70939495|NCT01375777|141379700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.11|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-53.33|-40.89||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-40.89|-53.33|<0.001
70939496|NCT01375777|141379700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.89|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-48.11|-35.67||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-35.67|-48.11|<0.001
70939497|NCT01375777|141379700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.7|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-43.92|-31.47||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-31.47|-43.92|<0.001
70939498|NCT01375777|141379701|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.19|STANDARD_ERROR_OF_MEAN|3.17|<|0.001|TWO_SIDED|95.0|-50.45|-37.94||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-37.94|-50.45|<0.001
70939499|NCT01375777|141379701|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.87|STANDARD_ERROR_OF_MEAN|3.13|<|0.001||95.0|-42.06|-29.69||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-29.69|-42.06|<0.001
70939500|NCT01375777|141379701|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.33|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-38.55|-26.11||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-26.11|-38.55|<0.001
70939501|NCT01375777|141379701|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-42.48|STANDARD_ERROR_OF_MEAN|3.12|<|0.001|TWO_SIDED|95.0|-48.63|-36.32||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-36.32|-48.63|<0.001
70939502|NCT01375777|141379701|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.92|STANDARD_ERROR_OF_MEAN|3.12|<|0.001|TWO_SIDED|95.0|-44.07|-31.76||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-31.76|-44.07|<0.001
70939503|NCT01375777|141379701|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.22|STANDARD_ERROR_OF_MEAN|3.12|<|0.001|TWO_SIDED|95.0|-39.38|-27.07||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-27.07|-39.38|<0.001
70939504|NCT01375777|141379702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.49|STANDARD_ERROR_OF_MEAN|3.01|<|0.001|TWO_SIDED|95.0|-43.43|-31.54||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-31.54|-43.43|<0.001
70939505|NCT01375777|141379702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.92|STANDARD_ERROR_OF_MEAN|2.98|<|0.001||95.0|-37.79|-26.04||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-26.04|-37.79|<0.001
70941965|NCT01524887|141384230|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.1||||0.783||95.0|-0.7|0.5|||Mixed Models Analysis|||||0.5|-0.7|0.783
71071498|NCT02612610|141651710|OTHER||LS Mean Difference|-0.3||||0.2837|TWO_SIDED|95.0|-1.0|0.3|||Mixed Effect Repeated Measures model|||"Week 2 DCS Total Score: 50 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-1.0|0.2837
70852915|NCT00797966|141194648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0064|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||-0.10|-0.60|0.0064
70852916|NCT00797966|141194649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68||||0.449|TWO_SIDED|95.0|-2.67|6.02|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||6.02|-2.67|0.4490
71071499|NCT02612610|141651711|OTHER||LS Mean Difference|0.1||||0.8084|TWO_SIDED|95.0|-0.6|0.8|||Mixed Effect Repeated Measures model|||"Week 3 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.8|-0.6|0.8084
71071500|NCT02612610|141651711|OTHER||LS Mean Difference|-0.2||||0.6108|TWO_SIDED|95.0|-0.8|0.5|||Mixed Effect Repeated Measures model|||"Week 3 DCS Total Score: 20 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.5|-0.8|0.6108
71071501|NCT02612610|141651711|OTHER||LS Mean Difference|-0.3||||0.422|TWO_SIDED|95.0|-0.9|0.4|||Mixed Effect Repeated Measures model|||"Week 3 DCS Total Score: 50 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.9|0.4220
71071502|NCT02612610|141651712|OTHER||LS Mean Difference|-0.1||||0.8457|TWO_SIDED|95.0|-0.7|0.6|||Mixed Effect Repeated Measures model|||"Week 4 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.6|-0.7|0.8457
71071503|NCT02612610|141651712|OTHER||LS Mean Difference|-0.3||||0.4044|TWO_SIDED|95.0|-0.9|0.4|||Mixed Effect Repeated Measures model|||"Week 4 DCS Total Score: 20 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.9|0.4044
71071504|NCT02612610|141651712|OTHER||LS Mean Difference|-0.3||||0.3031|TWO_SIDED|95.0|-1.0|0.3|||Mixed Effect Repeated Measures model|||"Week 4 DCS Total Score: 50 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-1.0|0.3031
71071505|NCT02612610|141651713|OTHER||LS Mean Difference|0.0||||0.9126|TWO_SIDED|95.0|-0.7|0.6|||Mixed Effect Repeated Measures model|||"Week 5 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.6|-0.7|0.9126
71071506|NCT02612610|141651713|OTHER||LS Mean Difference|-0.5||||0.1136|TWO_SIDED|95.0|-1.2|0.1|||Mixed Effect Repeated Measures model|||"Week 5 DCS Total Score: 20 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.2|0.1136
71071507|NCT02612610|141651713|OTHER||LS Mean Difference|-0.7||||0.0352|TWO_SIDED|95.0|-1.4|0.0|||Mixed Effect Repeated Measures model|||"Week 5 DCS Total Score: 50 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-0.0|-1.4|0.0352
71117701|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-70.6|||<|0.001|TWO_SIDED|95.0|-85.79|-55.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-55.41|-85.79|<0.001
70852917|NCT00797966|141194649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61||||0.7412|TWO_SIDED|95.0|-3.02|4.24|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||4.24|-3.02|0.7412
70852918|NCT00797966|141194649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.54||||0.407|TWO_SIDED|95.0|-2.1|5.17|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||5.17|-2.10|0.4070
71071508|NCT02612610|141651714|OTHER||LS Mean Difference|-0.5||||0.1718|TWO_SIDED|95.0|-1.1|0.2|||Mixed Effect Repeated Measures model|||"Week 6 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-1.1|0.1718
71071509|NCT02612610|141651714|OTHER||LS Mean Difference|-0.6||||0.0651|TWO_SIDED|95.0|-1.3|0.0|||Mixed Effect Repeated Measures model|||"Week 6 DCS Total Score: 20 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.0|-1.3|0.0651
71071510|NCT02612610|141651714|OTHER||LS Mean Difference|-0.6||||0.0848|TWO_SIDED|95.0|-1.2|0.1|||Mixed Effect Repeated Measures model|||"Week 6 DCS Total Score: 50 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.2|0.0848
71071511|NCT02612610|141651715|OTHER||LS Mean Difference|-0.1||||0.6715|TWO_SIDED|95.0|-0.8|0.5|||Mixed Effect Repeated Measures model|||"Week 7 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.5|-0.8|0.6715
70852919|NCT00797966|141194650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.4954|TWO_SIDED|95.0|-0.86|0.42|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||0.42|-0.86|0.4954
71071512|NCT02612610|141651715|OTHER||LS Mean Difference|-0.3||||0.3514|TWO_SIDED|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 7 DCS Total Score: 20 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-1.0|0.3514
70852920|NCT00797966|141194650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.4902|TWO_SIDED|95.0|-0.73|0.35|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||0.35|-0.73|0.4902
70852921|NCT00797966|141194650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.0161|TWO_SIDED|95.0|-1.2|-0.12|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||-0.12|-1.20|0.0161
71071513|NCT02612610|141651715|OTHER||LS Mean Difference|-0.4||||0.2809|TWO_SIDED|95.0|-1.1|0.3|||Mixed Effect Repeated Measures model|||"Week 7 DCS Total Score: 50 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-1.1|0.2809
71071514|NCT02612610|141651716|OTHER||LS Mean Difference|-0.2||||0.6022|TWO_SIDED|95.0|-0.9|0.5|||Mixed Effect Repeated Measures model|||"Week 8 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.5|-0.9|0.6022
71071515|NCT02612610|141651716|OTHER||LS Mean Difference|-0.3||||0.4456|TWO_SIDED|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 8 DCS Total Score: 20 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-1.0|0.4456
71071516|NCT02612610|141651716|OTHER||LS Mean Difference|-0.3||||0.4629|TWO_SIDED|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 8 DCS Total Score: 50 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-1.0|0.4629
71114315|NCT03989349|141736825|OTHER||Strata-adjusted percentage difference|16.3||||0.0004|TWO_SIDED|97.5|6.6|26.0||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||26.0|6.6|0.0004
71114316|NCT03989349|141736826|OTHER||Strata-adjusted percentage difference|23.2|||<|0.0001|TWO_SIDED|97.5|16.1|30.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level. Participants with missing data were considered non-responders.||30.3|16.1|<0.0001
71114317|NCT03989349|141736826|OTHER||Strata-adjusted percentage difference|27.8|||<|0.0001|TWO_SIDED|97.5|21.2|34.5||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel||The estimates are from 50 complete datasets by MI-MAR assumption.|Nemolizumab 30 mg versus Placebo using multiple imputation (MI) with missing at random (MAR) assumption.||34.5|21.2|<0.0001
71117702|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-71.66|||<|0.001|TWO_SIDED|95.0|-87.0|-56.31||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-56.31|-87.00|<0.001
70852922|NCT00797966|141194656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.5953|TWO_SIDED|95.0|-2.54|1.46|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||1.46|-2.54|0.5953
70852923|NCT00797966|141194656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.9479|TWO_SIDED|95.0|-1.66|1.55|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||1.55|-1.66|0.9479
70852924|NCT00797966|141194656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36||||0.0919|TWO_SIDED|95.0|-2.95|0.22|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||0.22|-2.95|0.0919
70852925|NCT00797966|141194657|SUPERIORITY_OR_OTHER|||||||0.3998||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||||0.3998
70941966|NCT01524887|141384231|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|1.1||||0.571||95.0|-2.6|4.7|||Mixed Models Analysis|||||4.7|-2.6|0.571
71071517|NCT02612610|141651717|OTHER||LS Mean Difference|-0.3||||0.3749|TWO_SIDED|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 9 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-1.0|0.3749
71071518|NCT02612610|141651717|OTHER||LS Mean Difference|-0.6||||0.0854|TWO_SIDED|95.0|-1.3|0.1|||Mixed Effect Repeated Measures model|||"Week 9 DCS Total Score: 20 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.3|0.0854
70939506|NCT01375777|141379702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.86|STANDARD_ERROR_OF_MEAN|2.99|<|0.001|TWO_SIDED|95.0|-34.77|-22.95||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-22.95|-34.77|<0.001
70939507|NCT01375777|141379702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.58|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-42.29|-30.88||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-30.88|-42.29|<0.001
70939508|NCT01375777|141379702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.21|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-36.92|-25.51||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-25.51|-36.92|<0.001
70939509|NCT01375777|141379702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.69|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-34.39|-22.98||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-22.98|-34.39|<0.001
70939510|NCT01375777|141379703|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.16|STANDARD_ERROR_OF_MEAN|3.34|<|0.001|TWO_SIDED|95.0|-56.75|-43.58||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-43.58|-56.75|<0.001
70939511|NCT01375777|141379703|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.33|STANDARD_ERROR_OF_MEAN|3.3|<|0.001||95.0|-46.84|-33.82||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-33.82|-46.84|<0.001
71071519|NCT02612610|141651717|OTHER||LS Mean Difference|-0.4||||0.2672|TWO_SIDED|95.0|-1.1|0.3|||Mixed Effect Repeated Measures model|||"Week 9 DCS Total Score: 50 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-1.1|0.2672
71071520|NCT02612610|141651718|OTHER||LS Mean Difference|-0.1||||0.7255|TWO_SIDED|95.0|-0.8|0.6|||Mixed Effect Repeated Measures model|||"Week 10 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.6|-0.8|0.7255
71071521|NCT02612610|141651718|OTHER||LS Mean Difference|-0.6||||0.0918|TWO_SIDED|95.0|-1.3|0.1|||Mixed Effect Repeated Measures model|||"Week 10 DCS Total Score: 20 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.3|0.0918
71071522|NCT02612610|141651718|OTHER||LS Mean Difference|-0.5||||0.1263|TWO_SIDED|95.0|-1.2|0.2|||Mixed Effect Repeated Measures model|||"Week 10 DCS Total Score: 50 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-1.2|0.1263
71071523|NCT02612610|141651719|OTHER||LS Mean Difference|-0.3||||0.4058|TWO_SIDED|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 11 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-1.0|0.4058
70852926|NCT00797966|141194657|SUPERIORITY_OR_OTHER|||||||0.8838||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||||0.8838
70939512|NCT01375777|141379703|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.83|STANDARD_ERROR_OF_MEAN|3.32|<|0.001|TWO_SIDED|95.0|-41.38|-28.28||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-28.28|-41.38|<0.001
70939513|NCT01375777|141379703|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.47|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-52.12|-38.82||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-38.82|-52.12|<0.001
70939514|NCT01375777|141379703|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.57|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-47.22|-33.92||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-33.92|-47.22|<0.001
71071524|NCT02612610|141651719|OTHER||LS Mean Difference|-0.6||||0.0828|TWO_SIDED|95.0|-1.3|0.1|||Mixed Effect Repeated Measures model|||"Week 11 DCS Total Score: 20 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.3|0.0828
71071525|NCT02612610|141651719|OTHER||LS Mean Difference|-0.7||||0.0575|TWO_SIDED|95.0|-1.4|0.0|||Mixed Effect Repeated Measures model|||"Week 11 DCS Total Score: 50 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.0|-1.4|0.0575
71117703|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-65.19|||<|0.001|TWO_SIDED|95.0|-81.03|-49.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-49.34|-81.03|<0.001
71071526|NCT02612610|141651720|OTHER||LS Mean Difference|-0.3||||0.4163|TWO_SIDED|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 12 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-1.0|0.4163
70939515|NCT01375777|141379703|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.25|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-42.9|-29.6||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-29.60|-42.90|<0.001
70939516|NCT02169089|141379704|SUPERIORITY||Median Difference (Final Values)|-7.78||||0.0293|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0293
70939517|NCT02169089|141379705|SUPERIORITY||Median Difference (Final Values)|-2.6|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The mean reported -3.5 and 2.1 represents the mean change between follow-up \& baseline visit. The statistical test (Mann-Whitney) reported Median difference of -2.6, which corresponds to the difference between the spironolactone and placebo group.|||||<0.0001
70939518|NCT02169089|141379706|SUPERIORITY||Median Difference (Final Values)|-40.7||||0.0189|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The mean reported -10.3 and 17.1 represents the mean change between follow-up \& baseline visit. The statistical test (Mann-Whitney) reported Median difference of -2.6, which corresponds to the difference between the spironolactone and placebo group.|||||0.0189
71071527|NCT02612610|141651720|OTHER||LS Mean Difference|-0.6||||0.0882|TWO_SIDED|95.0|-1.3|0.1|||Mixed Effect Repeated Measures model|||"Week 12 DCS Total Score: 20 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.3|0.0882
71071528|NCT02612610|141651720|OTHER||LS Mean Difference|-0.6||||0.0961|TWO_SIDED|95.0|-1.4|0.1|||Mixed Effect Repeated Measures model|||"Week 12 DCS Total Score: 50 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.4|0.0961
71071529|NCT02612610|141651721|OTHER||LS Mean Difference|0.8||||0.163|TWO_SIDED|95.0|-0.3|1.9|||Mixed Effect Repeated Measures model|||"Day 28 LCQ Total Score: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||1.9|-0.3|0.1630
71071530|NCT02612610|141651721|OTHER||LS Mean Difference|0.2||||0.7601|TWO_SIDED|95.0|-1.0|1.3|||Mixed Effect Repeated Measures model|||"Day 28 LCQ Total Score: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||1.3|-1.0|0.7601
70852927|NCT00797966|141194657|SUPERIORITY_OR_OTHER|||||||0.4012||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||||0.4012
70939519|NCT02169089|141379707|SUPERIORITY||Median Difference (Final Values)|-7.5||||0.1276|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The mean reported -5.95 and 2 represents the mean change between follow-up \& baseline visit. The statistical test (Mann-Whitney) reported Median difference of -2.6, which corresponds to the difference between the spironolactone and placebo group.|||||0.1276
70939520|NCT01838499|141379709|SUPERIORITY_OR_OTHER||Difference in proportions|0.051|||>|0.05|TWO_SIDED|80.0|-0.067|0.169|||Mixed Models Analysis||MEDI8968 - placebo|Analysis of proportion of Responders for Physician's Global Assessment (PGA score 0, 1 or 2) at Week 12 - LOCF. Difference in proportions MEDI8968 - placebo. Wald asymptotic confidence limits calculated.||0.169|-0.067|>0.05
71071531|NCT02612610|141651721|OTHER||LS Mean Difference|2.1||||0.0004|TWO_SIDED|95.0|0.9|3.2|||Mixed Effect Repeated Measures model|||"Day 28 LCQ Total Score: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||3.2|0.9|0.0004
71071532|NCT02612610|141651722|OTHER||LS Mean Difference|1.0||||0.0941|TWO_SIDED|95.0|-0.2|2.3|||Mixed Effect Repeated Measures model|||"Day 56 LCQ Total Score: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||2.3|-0.2|0.0941
70939521|NCT01838499|141379710|SUPERIORITY_OR_OTHER||Difference in proportions|-0.065|||>|0.05|TWO_SIDED|80.0|-0.205|0.076|||Mixed Models Analysis|||Difference in proportions MEDI8968 - placebo. Wald asymptotic confidence limits calculated.||0.076|-0.205|>0.05
70939522|NCT01838499|141379711|SUPERIORITY_OR_OTHER||Change from baseline (at week 12)|-0.03||||0.945|TWO_SIDED|80.0|-0.63|0.57|||ANCOVA||MEDI8968 - Placebo|Analysis of change from baseline (Week 12) estimated from ANCOVA model with tmt group and PGA stratum at randomisation included in the model and average daily pain at baseline as a covariate||0.57|-0.63|0.945
70939523|NCT01114217|141379735|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70941967|NCT01524887|141384231|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|3.7||||0.032||95.0|0.3|7.1|||Mixed Models Analysis|||||7.1|0.3|0.032
71071533|NCT02612610|141651722|OTHER||LS Mean Difference|0.9||||0.1321|TWO_SIDED|95.0|-0.3|2.2|||Mixed Effect Repeated Measures model|||"Day 56 LCQ Total Score: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||2.2|-0.3|0.1321
71071534|NCT02612610|141651722|OTHER||LS Mean Difference|1.5||||0.0192|TWO_SIDED|95.0|0.2|2.7|||Mixed Effect Repeated Measures model|||"Day 56 LCQ Total Score: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||2.7|0.2|0.0192
70939524|NCT01183013|141379742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.1571||95.0|-0.41|0.07||The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.|ANCOVA|||Treatment comparisons are for fixed dose combination versus monotherapy.||0.07|-0.41|0.1571
70939525|NCT01183013|141379742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.0016|TWO_SIDED|95.0|-0.6|-0.14|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-0.14|-0.60|0.0016
70939526|NCT01183013|141379742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.0006|TWO_SIDED|95.0|-0.64|-0.18|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-0.18|-0.64|0.0006
70939527|NCT01183013|141379742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.0003|TWO_SIDED|95.0|-0.67|-0.2|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-0.20|-0.67|0.0003
70939528|NCT01183013|141379742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|||<|0.0001|TWO_SIDED|95.0|-0.91|-0.44|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-0.44|-0.91|<0.0001
71071535|NCT02612610|141651723|OTHER||LS Mean Difference|1.2||||0.0626|TWO_SIDED|95.0|-0.1|2.4|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination LCQ Total Score: 7.5 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||2.4|-0.1|0.0626
70939529|NCT01183013|141379742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|||<|0.0001|TWO_SIDED|95.0|-1.12|-0.66|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-0.66|-1.12|<0.0001
71071536|NCT02612610|141651723|OTHER||LS Mean Difference|1.0||||0.0967|TWO_SIDED|95.0|-0.2|2.3|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination LCQ Total Score: 20 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||2.3|-0.2|0.0967
71071537|NCT02612610|141651723|OTHER||LS Mean Difference|1.9||||0.0028|TWO_SIDED|95.0|0.7|3.1|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination LCQ Total Score: 50 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||3.1|0.7|0.0028
71071538|NCT02612610|141651724|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3182|||||||Cochran-Mantel-Haenszel|||"Day 28 PGIC: 7.5 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.3182
71071539|NCT02612610|141651724|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5021|||||||Cochran-Mantel-Haenszel|||"Day 28 PGIC: 20 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.5021
70939530|NCT01183013|141379743|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.246||||0.4639||95.0|0.692|2.242|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||2.242|0.692|0.4639
70939531|NCT01183013|141379743|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.746||||0.0546||95.0|0.989|3.083|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||3.083|0.989|0.0546
70939532|NCT01183013|141379743|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.903||||0.0254||95.0|1.083|3.345|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||3.345|1.083|0.0254
70939533|NCT01183013|141379743|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.804||||0.0009||95.0|1.524|5.159|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||5.159|1.524|0.0009
70939534|NCT01183013|141379743|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.429|||<|0.0001||95.0|2.947|10.001|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||10.001|2.947|<0.0001
70941968|NCT01524887|141384232|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.00026||||0.593||95.0|-0.00126|0.00073|||ANCOVA|||||0.00073|-0.00126|0.593
71071540|NCT02612610|141651724|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0665|||||||Cochran-Mantel-Haenszel|||"Day 28 PGIC: 50 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0665
71071541|NCT02612610|141651725|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0872|||||||Cochran-Mantel-Haenszel|||"Day 56 PGIC: 7.5 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0872
71071542|NCT02612610|141651725|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0994|||||||Cochran-Mantel-Haenszel|||"Day 56 PGIC: 20 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0994
71071543|NCT02612610|141651725|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009|||||||Cochran-Mantel-Haenszel|||"Day 56 PGIC: 50 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0009
71071544|NCT02612610|141651726|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0037|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination PGIC: 7.5 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0037
71071545|NCT02612610|141651726|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0166|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination PGIC: 20 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0166
71071546|NCT02612610|141651726|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination: 50 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||<0.0001
71071547|NCT02612610|141651727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0396|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination CGIC: 7.5 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0396
71071548|NCT02612610|141651727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0751|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination CGIC: 20 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0751
71071549|NCT02612610|141651727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination CGIC: 50 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0010
71071550|NCT02612610|141651728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8464|||||||Cochran-Mantel-Haenszel|||"1 Year Acceptability: 7.5 mg gefapixant vs. placebo~The distribution of Extremely likely responses was compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for the gefapixant vs. placebo using CMH test."||||0.8464
71071551|NCT02612610|141651728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7687|||||||Cochran-Mantel-Haenszel|||"1 Year Acceptability: 20 mg gefapixant vs. placebo~The distribution of Extremely likely responses was compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.7687
71071552|NCT02612610|141651728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4364|||||||Cochran-Mantel-Haenszel|||"1 Year Acceptability: 50 mg gefapixant vs. placebo~The distribution of Extremely likely responses was compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.4364
71071553|NCT02612610|141651729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9966|||||||Cochran-Mantel-Haenszel|||"6 Month Acceptability: 7.5 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.9966
71071554|NCT02612610|141651729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6372|||||||Cochran-Mantel-Haenszel|||"6 Month Acceptability: 20 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.6372
71114318|NCT03989349|141736827|OTHER||Strata-adjusted percentage difference|27.1|||<|0.0001|TWO_SIDED|97.5|17.5|36.6||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\].|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level. Participants with missing data were considered non-responders.||36.6|17.5|<0.0001
71114319|NCT03989349|141736827|OTHER||Strata-adjusted percentage difference|33.4|||<|0.0001|TWO_SIDED|97.5|24.5|42.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\].|Cochran-Mantel-Haenszel||The estimates are from 50 complete datasets by MI-MAR assumption.|Nemolizumab 30 mg versus Placebo using MI-MAR assumption.||42.3|24.5|<0.0001
71071555|NCT02612610|141651729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2155|||||||Cochran-Mantel-Haenszel|||"6 Month Acceptability: 50 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.2155
71071556|NCT02612610|141651730|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7559|||||||Cochran-Mantel-Haenszel|||"4 Week Acceptability: 7.5 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.7559
71071557|NCT02612610|141651730|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5091|||||||Cochran-Mantel-Haenszel|||"4 Week Acceptability: 20 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.5091
71071558|NCT02612610|141651730|SUPERIORITY_OR_OTHER_LEGACY|||||||0.279|||||||Cochran-Mantel-Haenszel|||"4 Week Acceptability: 50 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.2790
71114320|NCT03989349|141736828|OTHER||Strata-adjusted percentage difference|17.1|||<|0.0001|TWO_SIDED|97.5|10.9|23.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||23.3|10.9|<0.0001
71114321|NCT03989349|141736829|OTHER||Strata-adjusted percentage difference|18.4|||<|0.0001|TWO_SIDED|97.5|11.0|25.8||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||25.8|11.0|<0.0001
71114322|NCT03989349|141736830|OTHER||Strata-adjusted percentage difference|17.5|||<|0.0001|TWO_SIDED|97.5|10.8|24.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||24.3|10.8|< 0.0001
71114323|NCT03989349|141736831|OTHER||Strata-adjusted percentage difference|21.9|||<|0.0001|TWO_SIDED|97.5|12.5|31.4||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||31.4|12.5|<0.0001
71114324|NCT03989349|141736832|OTHER||Strata-adjusted percentage difference|20.9|||<|0.0001|TWO_SIDED|97.5|15.6|26.1||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting the randomized stratification variables (IGA severity and PP NRS).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||26.1|15.6|< 0.0001
71114325|NCT03989349|141736833|OTHER||Strata-adjusted percentage difference|22.5|||<|0.0001|TWO_SIDED|97.5|15.0|29.9||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||29.9|15.0|<0.0001
71114326|NCT03989349|141736834|OTHER||Strata-adjusted percentage difference|13.2|||<|0.0001|TWO_SIDED|97.5|9.0|17.4||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||17.4|9|< 0.0001
71114327|NCT03989349|141736835|OTHER||Strata-adjusted percentage difference|9.9||||0.0001|TWO_SIDED|97.5|5.5|14.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||14.3|5.5|0.0001
71114328|NCT03989349|141736836|OTHER||Strata-adjusted percentage difference|15.1|||<|0.0001|TWO_SIDED|97.5|11.0|19.2||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level||19.2|11|< 0.0001
71071559|NCT02612610|141651731|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3887|||||||Cochran-Mantel-Haenszel|||"Twice Daily Acceptability: 7.5 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.3887
71071560|NCT02612610|141651731|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2333|||||||Cochran-Mantel-Haenszel|||"Twice Daily Acceptability: 20 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.2333
71071561|NCT02612610|141651731|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0534|||||||Cochran-Mantel-Haenszel|||"Twice Daily Acceptability: 50 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.0534
71071562|NCT02612610|141651732|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6115|||||||Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 7.5 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Never responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.6115
71114329|NCT03989349|141736837|OTHER||Strata-adjusted percentage difference|16.3|||<|0.0001|TWO_SIDED|97.5|10.5|22.1||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||22.1|10.5|<0.0001
71114330|NCT03989349|141736838|OTHER||Strata-adjusted percentage difference|6.4|||<|0.0001|TWO_SIDED|97.5|3.8|9.1||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||9.1|3.8|<0.0001
71114331|NCT03989349|141736839|OTHER||Strata-adjusted percentage difference|8.0||||0.0004|TWO_SIDED|97.5|4.2|11.8||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for preceding outcome measure was statistically significant at two-sided 2.5% significance level.||11.8|4.2|0.0004
71114332|NCT01352221|141736840|SUPERIORITY||Mean Difference (Final Values)|2.18|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|ONE_SIDED|97.5|1.81||||ANCOVA|||ANCOVA for primary endpoint, Change in Hb concentration from Baseline to Week 12 in double-blind phase, FAS|||1.81|< 0.0001
71114333|NCT01352221|141736844|SUPERIORITY||Mean Difference (Final Values)|1.04|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|ONE_SIDED|97.5|0.82||||ANCOVA|||ANCOVA analysis of the change in Hb concentration from Baseline to Week 4 of the double-blind phase - Full Analysis Set, multiple imputation|||0.82|< 0.0001
71114334|NCT01352221|141736845|SUPERIORITY||Mean Difference (Final Values)|1.73|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|ONE_SIDED|97.5|1.43|||ANCOVA analysis of Change in Hb concentration from Baseline to Week 8 of double-blind phase - FAS, multiple imputation|ANCOVA||||||1.43|< 0.0001
71114335|NCT01352221|141736856|SUPERIORITY||Mean Difference (Final Values)|2.18|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|ONE_SIDED|97.5|1.87||||ANCOVA|||ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the PPAS|||1.87|< 0.0001
71114336|NCT01352221|141736857|SUPERIORITY||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|ONE_SIDED|97.5|1.82||||ANCOVA|||ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the FAS LOCF Change in Haemoglobin Concentration from Baseline to Week 12|||1.82|< 0.0001
71114337|NCT02016716|141736866|NON_INFERIORITY|Non-inferiority was claimed if the lower bound of the 1-sided 97.5% CI (or the lower bound of 2-sided 95% CI) of the mean difference between the 2 romosozumab groups was \> -2.0%.|Least Squares Mean Difference|-0.4|||||TWO_SIDED|95.0|-1.5|0.7|||||Based on ANCOVA model adjusting for treatment, and baseline lumbar spine BMD T-score.|The primary hypothesis was that the mean percent change from baseline in lumbar spine BMD at month 6 in participants receiving romosozumab 210 mg QM using the 90 mg/mL concentration would not be inferior to that in participants receiving romosozumab 210 mg QM using the 70 mg/mL concentration.||0.7|-1.5|
71114338|NCT02248649|141736871|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|covariates: baseline age and years of education||||||0.2
71114339|NCT02248649|141736872|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||0.04
71114340|NCT02248649|141736873|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||||||0.02
71114341|NCT00147017|141736913|SUPERIORITY|||||||0.05||||||calculated|Kruskal-Wallis|||||||0.05
71114342|NCT00147017|141736914|SUPERIORITY|||||||0.05||||||calculated|Kruskal-Wallis|||||||0.05
71114343|NCT00147017|141736915|SUPERIORITY|||||||0.05||||||calculated|Kruskal-Wallis|||||||0.05
71114344|NCT01221623|141736919|SUPERIORITY_OR_OTHER|||||||0.0059|TWO_SIDED||||||ANOVA|||||||.0059
71114345|NCT01221623|141736920|SUPERIORITY_OR_OTHER|||||||0.0496|TWO_SIDED||||||ANOVA|||||||.0496
71114346|NCT01221623|141736921|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
71114347|NCT01221623|141736922|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||ANOVA|||||||.0340
71114348|NCT01221623|141736923|SUPERIORITY_OR_OTHER|||||||0.1168|TWO_SIDED||||||ANOVA|||||||.1168
71114349|NCT01221623|141736924|SUPERIORITY_OR_OTHER|||||||0.0144|TWO_SIDED||||||ANOVA|||||||.0144
71114350|NCT01221623|141736925|SUPERIORITY_OR_OTHER|||||||0.0248|TWO_SIDED||||||ANOVA|||||||.0248
71114351|NCT01221623|141736926|SUPERIORITY_OR_OTHER|||||||0.6949|TWO_SIDED||||||ANOVA|||||||.6949
71114352|NCT01221623|141736927|SUPERIORITY_OR_OTHER|||||||0.0249|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||.0249
71114353|NCT01631747|141736956|SUPERIORITY|||||||0.01||||||p-value is not adjusted for multiple comparisons, and tested at an a priori type I error rate of 0.05.|t-test, 2 sided|||Sample size was based on an independent 2-sample t-test using a two-sided type 1 error rate of 0.05, and 80% power. Assuming a standard deviation (SD) of 15lbs (6.8kg), a clinically meaningful difference of 5lbs (2.4kg) between groups, and 10% attrition, a sample size of 150/group was required.||||0.01
71114354|NCT01631747|141736956|SUPERIORITY|||||||0.02|||||||Regression, Linear|adjusted for actual gestational age of 36 week weight, gestational age, bmi, and maternal age at randomization, maternal race and paternal race.||||||0.02
71114355|NCT01631747|141736957|SUPERIORITY|||||||0.54|||||||Chi-squared|||||||0.54
71114356|NCT01631747|141736958|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|T-test performed on change in glucose (log scale), but presented as Median and inter-quartile range for interpretability||||||0.89
71114357|NCT01631747|141736959|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|t-test performed on changes in HDL, but presented as median and IQR for ease of interpretation||||||0.30
71114358|NCT01631747|141736960|SUPERIORITY|||||||0.69|||||||t-test, 2 sided|t-test run on changes between groups. Data presented as median and IQR for ease of interpretation||||||0.69
71114359|NCT01631747|141736961|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|t-test run on change between groups (log scale), but presented as median and IQR for ease of interpretation||||||0.19
71114360|NCT01631747|141736962|SUPERIORITY|||||||0.27|||||||t-test, 2 sided|t-test used to compare changes between groups (log scale). Median and IQR are presented for ease of interpretation.||||||0.27
71114361|NCT01631747|141736963|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|t-test performed on changes between groups (log scale). Median and IQR are presented for ease of interpretation||||||0.003
71114362|NCT01631747|141736964|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|t-test run on change between groups (log scale), but presented as median and IQR for ease of interpretation||||||0.24
71114363|NCT01631747|141736965|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|t-test run on change between groups (log scale), but presented as median and IQR for ease of interpretation||||||0.32
71114364|NCT01631747|141736966|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|T-test performed on change between groups (log scale). Median and IQR are presented for ease of interpretation||||||0.26
71114365|NCT01631747|141736967|SUPERIORITY|||||||0.62|||||||t-test, 2 sided|||||||0.62
71114366|NCT01631747|141736968|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||||||0.61
71114367|NCT01631747|141736969|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||||||0.42
70939535|NCT01183013|141379743|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.614|||<|0.0001||95.0|5.187|17.821|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||17.821|5.187|<0.0001
71114368|NCT01631747|141736970|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||0.25
71114369|NCT01631747|141736971|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||||||0.66
71114370|NCT01631747|141736972|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||||||0.94
71114371|NCT02908685|141736975|SUPERIORITY|This is the first end point and first family tested in the hierarchical testing. The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|1.55||||0.0156|TWO_SIDED|95.0|0.3|2.81|||Mixed Model Repeated Measure Analysis|||||2.81|0.30|0.0156
71114372|NCT02908685|141736976|SUPERIORITY|This is the second end point and second family tested in the hierarchical testing. Logistic Regression Model.The variables included in the logistic regression are: baseline total score, treatment and age group.|Odds Ratio (OR)|2.35||||0.0469|TWO_SIDED|95.0|1.01|5.44||Adjusted p-Value The adjusted p-values were derived based on all the p-values from end points in order of the hierarchical testing up to the current endpoint.|Wald test|||||5.44|1.01|0.0469
71114373|NCT02908685|141736977|SUPERIORITY|This is the third end point and third family tested in the hierarchical testing. The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|1.59||||0.0469|TWO_SIDED|95.0|0.55|2.62||Adjusted p-Value The adjusted p-values were derived based on all the p-values from end points in order of the hierarchical testing up to the current endpoint.|Mixed Model Repeated Measure Analysis|||||2.62|0.55|0.0469
71114374|NCT02908685|141736978|SUPERIORITY|This is one of the two end points in family four in the hierarchical testing. The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|0.58||||0.3902|TWO_SIDED|95.0|-0.53|1.69||Adjusted p-Value The adjusted p-values were derived based on all the p-values from end points in order of the hierarchical testing up to the current endpoint.|Mixed Model Repeated Measure Analysis|||||1.69|-0.53|0.3902
71114375|NCT02908685|141736979|SUPERIORITY|This is one of the two end points in family four in the hierarchical testing. The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|-2.05||||0.3902|TWO_SIDED|95.0|-6.67|2.56||Adjusted p-Value The adjusted p-values were derived based on all the p-values from end points in order of the hierarchical testing up to the current endpoint.|Mixed Model Repeated Measure Analysis|||||2.56|-6.67|0.3902
71114376|NCT02908685|141736980|SUPERIORITY|This is the sixth endpoint and the fifth family tested in the hierarchical testing. The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|2.55||||0.3902|TWO_SIDED|95.0|0.93|4.17||Adjusted p-Value The adjusted p-values were derived based on all the p-values from end points in order of the hierarchical testing up to the current endpoint.|Mixed Model Repeated Measure Analysis|||||4.17|0.93|0.3902
71114377|NCT02908685|141736981|SUPERIORITY|This is the seventh endpoint and the sixth family tested in the hierarchical testing. Logistic Regression Model. The variables included in the logistic regression are: baseline total score, treatment and age group.|Odds Ratio (OR)|1.38||||0.3902|TWO_SIDED|95.0|0.7|2.74||Adjusted p-Value The adjusted p-values were derived based on all the p-values from end points in order of the hierarchical testing up to the current endpoint.|Wald-test|||CGI Improved||2.74|0.70|0.3902
71114378|NCT02908685|141736982|SUPERIORITY|Logistic Regression Model. The variables included in the logistic regression are: baseline total score, treatment and age group.|Odds Ratio (OR)|2.0||||0.043|TWO_SIDED|95.0|1.02|3.93|||Wald test|||||3.93|1.02|0.0430
71114379|NCT02908685|141736984|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|0.64||||0.1328|TWO_SIDED|95.0|-0.2|1.47|||Mixed Model Repeated Measure Analysis|||||1.47|-0.20|0.1328
70852928|NCT00797966|141194657|SUPERIORITY_OR_OTHER|||||||0.6131||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||||0.6131
71114380|NCT02908685|141736985|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|1.97||||0.103|TWO_SIDED|95.0|-0.4|4.34|||Mixed Model Repeated Measure Analysis|||||4.34|-0.40|0.1030
71114381|NCT02908685|141736986|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|2.34||||0.0451|TWO_SIDED|95.0|0.05|4.62|||Mixed Model Repeated Measure Analysis|||||4.62|0.05|0.0451
71114382|NCT02908685|141736987|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|1.28||||0.0489|TWO_SIDED|95.0|0.01|2.56|||Mixed Model Repeated Measure Analysis|||||2.56|0.01|0.0489
70852929|NCT00797966|141194657|SUPERIORITY_OR_OTHER|||||||0.5964||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||||0.5964
71071563|NCT02612610|141651732|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 20 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Never responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||<0.0001
71071564|NCT02612610|141651732|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 50 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Never responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||<0.0001
71071565|NCT02612610|141651733|SUPERIORITY_OR_OTHER_LEGACY|||||||0||||||"A p-value of zero was calculated if all participants (100%) had No Taste Effect Noted or Not at All responses in both comparison groups."|Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 7.5 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Not at All responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0
71071566|NCT02612610|141651733|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 20 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Not at All responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||<0.0001
71071567|NCT02612610|141651733|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 50 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Not at All responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||<0.0001
71071568|NCT02783729|141651740|SUPERIORITY||Least Squares Geometric Mean(LSGM) Ratio|0.773|||=|0.0003|TWO_SIDED|95.0|0.672|0.889||Based on mixed effect model repeated measurement (MMRM) model with log transformation of LPS and factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||||0.889|0.672|= 0.0003
71071569|NCT02783729|141651740|SUPERIORITY||LSGM Ratio|0.723|||<|0.0001|TWO_SIDED|95.0|0.628|0.832||Based on MMRM model with log transformation of LPS and factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||||0.832|0.628|< 0.0001
71071570|NCT02783729|141651741|SUPERIORITY||Least Squares Mean (LSM) Difference|7.07|STANDARD_ERROR_OF_MEAN|0.746|<|0.0001|TWO_SIDED|95.0|5.61|8.54||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline SE as a covariate.|MMRM|||||8.54|5.61|< 0.0001
71071571|NCT02783729|141651741|SUPERIORITY||LSM Difference|8.03|STANDARD_ERROR_OF_MEAN|0.746|<|0.0001|TWO_SIDED|95.0|6.57|9.49||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline SE as a covariate.|MMRM|||||9.49|6.57|< 0.0001
71071572|NCT02783729|141651742|SUPERIORITY||LSM Difference|-23.96|STANDARD_ERROR_OF_MEAN|3.068|<|0.0001|TWO_SIDED|95.0|-29.98|-17.95||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline WASO as a covariate.|MMRM|||||-17.95|-29.98|< 0.0001
71071573|NCT02783729|141651742|SUPERIORITY||LSM Difference|-25.35|STANDARD_ERROR_OF_MEAN|3.067|<|0.0001|TWO_SIDED|95.0|-31.36|-19.34|||MMRM|||||-19.34|-31.36|< 0.0001
71071574|NCT02783729|141651743|SUPERIORITY|Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline WASO2H as a covariate.|LSM Difference|-6.65|STANDARD_ERROR_OF_MEAN|2.298|=|0.0038|TWO_SIDED|95.0|-11.15|-2.15|||MMRM|||||-2.15|-11.15|= 0.0038
71071575|NCT02783729|141651743|SUPERIORITY|Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline WASO2H as a covariate.|LSM Difference|-8.0|STANDARD_ERROR_OF_MEAN|2.309|=|0.0005|TWO_SIDED|95.0|-12.53|-3.47|||MMRM|||||-3.47|-12.53|= 0.0005
71071576|NCT02783729|141651744|SUPERIORITY||LSM Difference|-9.63|STANDARD_ERROR_OF_MEAN|4.029|=|0.0171|TWO_SIDED|95.0|-17.53|-1.72||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effect, and the baseline posture stability of body sway as a covariate.|MMRM|||Zolpidem Tartrate Extended Release 6.25 mg v Lemborexant 5 mg||-1.72|-17.53|= 0.0171
71071577|NCT02783729|141651744|SUPERIORITY||LSM Difference|-10.74|STANDARD_ERROR_OF_MEAN|4.04|=|0.008|TWO_SIDED|95.0|-18.67|-2.81||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effect, and the baseline posture stability of body sway as a covariate.|MMRM|||Zolpidem Tartrate Extended Release 6.25 mg v Lemborexant 10 mg||-2.81|-18.67|= 0.008
71071578|NCT02783729|141651745|SUPERIORITY||LSGM Ratio|0.874|||=|0.0218|TWO_SIDED|95.0|0.78|0.981||Based on MMRM model with log transformation of LPS and factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS, Days 1/2: Zolpidem ER, Lemborexant 5 mg||0.981|0.78|= 0.0218
71071579|NCT02783729|141651745|OTHER||LSGM Ratio|0.818|||=|0.0006|TWO_SIDED|95.0|0.729|0.917||Based on MMRM model with log transformation of LPS and factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS, Days 1/2: Zolpidem ER, Lemborexant 10 mg||0.917|0.729|= 0.0006
71114383|NCT02908685|141736988|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|2.16||||0.0326|TWO_SIDED|95.0|0.18|4.14|||Mixed Model Repeated Measure Analysis|||||4.14|0.18|0.0326
70852930|NCT00797966|141194657|SUPERIORITY_OR_OTHER|||||||0.254||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||||0.2540
70852931|NCT00797966|141194657|SUPERIORITY_OR_OTHER|||||||0.8524||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||||0.8524
71114384|NCT02908685|141736989|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|-2.87||||0.3029|TWO_SIDED|95.0|-8.36|2.62|||Mixed Model Repeated Measure Analysis|||||2.62|-8.36|0.3029
70939536|NCT01183013|141379744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.126||||0.7359||95.0|0.565|2.243|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||2.243|0.565|0.7359
70939537|NCT01183013|141379744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.905||||0.0363||95.0|1.042|3.484|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||3.484|1.042|0.0363
70939538|NCT01183013|141379744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.269||||0.4039||95.0|0.726|2.217|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||2.217|0.726|0.4039
70939539|NCT01183013|141379744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.22||||0.0345||95.0|1.06|4.649|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||4.649|1.060|0.0345
70852932|NCT00797966|141194657|SUPERIORITY_OR_OTHER|||||||0.6969||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||||0.6969
70939540|NCT01183013|141379744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.58|||<|0.0001||95.0|2.263|9.266|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||9.266|2.263|<0.0001
70939541|NCT01183013|141379744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.066|||<|0.0001||95.0|2.53|10.145|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||10.145|2.530|<0.0001
70939542|NCT01183013|141379745|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.754||95.0|0.637|1.863|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||1.863|0.637|0.7540
70939543|NCT01183013|141379745|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.707||||0.0506||95.0|0.999|2.918|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||2.918|0.999|0.0506
71071580|NCT02783729|141651745|SUPERIORITY||LSGM Ratio|0.634|||<|0.0001|TWO_SIDED|95.0|0.556|0.724||Based on MMRM model with log transformation of LPS and factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS, Days 29/30: Zolpidem ER, Lemborexant 5 mg||0.724|0.556|< 0.0001
71114385|NCT02908685|141736990|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|1.28||||0.4937|TWO_SIDED|95.0|-2.42|4.99|||Mixed Model Repeated Measure Analysis|||||4.99|-2.42|0.4937
71114386|NCT02908685|141736991|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|2.35||||0.3967|TWO_SIDED|95.0|-3.11|7.8|||Mixed Model Repeated Measure Analysis|||||7.80|-3.11|0.3967
70939544|NCT01183013|141379745|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.966||||0.0005|TWO_SIDED|95.0|1.604|5.485|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||5.485|1.604|0.0005
70939545|NCT01183013|141379745|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.696||||0.0002||95.0|1.594|4.559|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||4.559|1.594|0.0002
70939546|NCT01183013|141379745|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.017|||<|0.0001||95.0|2.348|6.873|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||6.873|2.348|<0.0001
70939547|NCT01183013|141379745|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.521|||<|0.0001||95.0|4.63|15.681|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||15.681|4.630|<0.0001
70939548|NCT01183013|141379747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.68||||0.4275|TWO_SIDED|95.0|-12.77|5.42|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||5.42|-12.77|0.4275
71071581|NCT02783729|141651745|SUPERIORITY||LSGM Ratio|0.594|||<|0.0001|TWO_SIDED|95.0|0.521|0.677||Based on MMRM model with log transformation of LPS and factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS, Days 29/30: Zolpidem ER, Lemborexant 10 mg||0.677|0.521|< 0.0001
71114387|NCT02908685|141736992|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|2.96||||0.6704|TWO_SIDED|95.0|-10.78|16.7|||Mixed Model Repeated Measure Analysis|||||16.70|-10.78|0.6704
71114388|NCT02908685|141736993|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|-0.43||||0.8856|TWO_SIDED|95.0|-6.3|5.45|||Mixed Model Repeated Measure Analysis|||||5.45|-6.30|0.8856
70852933|NCT00797966|141194657|SUPERIORITY_OR_OTHER|||||||0.3108||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||||0.3108
71114389|NCT02908685|141736994|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|1.45||||0.1778|TWO_SIDED|95.0|-0.68|3.57|||Mixed Model Repeated Measure Analysis|||||3.57|-0.68|0.1778
71114390|NCT02908685|141736995|SUPERIORITY|Logistic Regression Model. The variables included in the logistic regression are: baseline total score, treatment and age group.|Odds Ratio (OR)|1.21||||0.6636|TWO_SIDED|95.0|0.52|2.83|||Wald-test|||CGI No Change or Improved||2.83|0.52|0.6636
71114391|NCT01691014|141737023|SUPERIORITY_OR_OTHER|||||||0.99|||||||Fisher Exact|||DAS28: Month 3: Continuous variables were compared between treatment groups using one way analysis of variance (ANOVA).||||0.990
71114392|NCT01691014|141737023|SUPERIORITY_OR_OTHER|||||||0.586|||||||Fisher Exact|||DAS28: Month 6: Continuous variables were compared between treatment groups using one way ANOVA.||||0.586
71114393|NCT01691014|141737023|SUPERIORITY_OR_OTHER|||||||0.98|||||||Fisher Exact|||DAS28: Month 12: Continuous variables were compared between treatment groups using one way ANOVA.||||0.980
71114394|NCT01691014|141737024|SUPERIORITY_OR_OTHER|||||||0.945|||||||Fisher Exact|||HAQ: Baseline: Continuous variables were compared between treatment groups using one way ANOVA.||||0.945
71114395|NCT01691014|141737024|SUPERIORITY_OR_OTHER|||||||0.458|||||||Fisher Exact|||HAQ: Month 3: Continuous variables were compared between treatment groups using one way ANOVA.||||0.458
71114396|NCT01691014|141737024|SUPERIORITY_OR_OTHER|||||||0.896|||||||Fisher Exact|||HAQ: Month 6: Continuous variables were compared between treatment groups using one way ANOVA.||||0.896
71114397|NCT01691014|141737024|SUPERIORITY_OR_OTHER|||||||0.39|||||||Fisher Exact|||HAQ: Month 12: Continuous variables were compared between treatment groups using one way ANOVA.||||0.390
71114398|NCT02370537|141737026|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of least-square means (LSmeans) for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% Confidence Intervals (CIs) by degree of pancreatic exocrine function using level of FEC were exponentiated.|Geometric least-squares (GLS) Mean Ratio|0.75|||||TWO_SIDED|90.0|0.52|1.1|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.10|0.52|
71114399|NCT02370537|141737026|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean ratio|0.48|||||TWO_SIDED|90.0|0.32|0.72|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.72|0.32|
71114400|NCT02370537|141737026|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.6|||||TWO_SIDED|90.0|0.44|0.82|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.82|0.44|
71114401|NCT02370537|141737027|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|1.28|||||TWO_SIDED|90.0|0.84|1.93|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.93|0.84|
71114402|NCT02370537|141737027|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.8|||||TWO_SIDED|90.0|0.51|1.25|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.25|0.51|
71114403|NCT02370537|141737027|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|1.29|||||TWO_SIDED|90.0|0.92|1.82|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.82|0.92|
71114404|NCT02370537|141737028|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.9|||||TWO_SIDED|90.0|0.63|1.28|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.28|0.63|
71114405|NCT02370537|141737028|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.58|||||TWO_SIDED|90.0|0.39|0.85|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.85|0.39|
71114406|NCT02370537|141737028|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.75|||||TWO_SIDED|90.0|0.55|1.0|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.00|0.55|
71114407|NCT02370537|141737029|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.52|||||TWO_SIDED|90.0|0.37|0.73|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.73|0.37|
71114408|NCT02370537|141737029|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.46|||||TWO_SIDED|90.0|0.32|0.67|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.67|0.32|
71114409|NCT02370537|141737029|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.53|||||TWO_SIDED|90.0|0.4|0.7|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.70|0.40|
71114410|NCT02370537|141737030|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of least-squares LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|1.02|||||TWO_SIDED|90.0|0.77|1.36|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.36|0.77|
71114411|NCT02370537|141737030|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS mean Ratio|0.92|||||TWO_SIDED|90.0|0.67|1.25|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.25|0.67|
71114412|NCT02370537|141737030|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|1.11|||||TWO_SIDED|90.0|0.88|1.4|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.40|0.88|
71117704|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-11.7||||0.007|TWO_SIDED|95.0|-19.86|-3.55||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-3.55|-19.86|0.007
70939549|NCT01183013|141379747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.84||||0.6839|TWO_SIDED|95.0|-10.69|7.02|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||7.02|-10.69|0.6839
70941969|NCT01524887|141384232|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|0.00003||||0.94||95.0|-0.0008|0.00086|||ANCOVA|||||0.00086|-0.00080|0.940
70941970|NCT01524887|141384233|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.5||||0.633||95.0|-2.8|1.7|||Mixed Models Analysis|||||1.7|-2.8|0.633
70939550|NCT01183013|141379747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5||||0.1466|TWO_SIDED|95.0|-15.29|2.28|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||2.28|-15.29|0.1466
70939551|NCT01183013|141379747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.38||||0.0002|TWO_SIDED|95.0|-26.35|-8.41|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-8.41|-26.35|0.0002
70939552|NCT01183013|141379747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.87|||<|0.0001|TWO_SIDED|95.0|-34.77|-16.98|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-16.98|-34.77|<0.0001
70939553|NCT01183013|141379747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.73|||<|0.0001|TWO_SIDED|95.0|-42.57|-24.89|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-24.89|-42.57|<0.0001
70939554|NCT01183013|141379749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.61||||0.0057|TWO_SIDED|95.0|-62.42|-10.8|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-10.80|-62.42|0.0057
70939555|NCT01183013|141379749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.94||||0.7021||95.0|-30.39|20.51|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||20.51|-30.39|0.7021
70939556|NCT01183013|141379749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.78||||0.8932|TWO_SIDED|95.0|-27.95|24.38|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||24.38|-27.95|0.8932
70939557|NCT01183013|141379749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.65||||0.2706|TWO_SIDED|95.0|-43.6|12.3|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||12.30|-43.60|0.2706
70939558|NCT01183013|141379749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.33||||0.0126|TWO_SIDED|95.0|-64.78|-7.89|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-7.89|-64.78|0.0126
70939559|NCT01183013|141379749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.16||||0.0167|TWO_SIDED|95.0|-60.23|-6.08|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-6.08|-60.23|0.0167
71071582|NCT02783729|141651745|SUPERIORITY||LSM Difference|-6.16|STANDARD_ERROR_OF_MEAN|2.544|=|0.0154|TWO_SIDED|95.0|-11.15|-1.17||Based on MMRM model with factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline WASO as a covariate.|MMRM|||WASO, Days 1/2: Zolpidem ER, Lemborexant 5 mg||-1.17|-11.15|= 0.0154
71114413|NCT02370537|141737031|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean|0.68|||||TWO_SIDED|90.0|0.49|0.92|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.92|0.49|
70852934|NCT00797966|141194657|SUPERIORITY_OR_OTHER|||||||0.8719||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||||0.8719
70939560|NCT01183013|141379751|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.649||||0.3052||95.0|0.284|1.482|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||1.482|0.284|0.3052
70939561|NCT01183013|141379751|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.456||||0.0844|TWO_SIDED|95.0|0.187|1.112|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||1.112|0.187|0.0844
70939562|NCT01183013|141379751|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.443||||0.1561|TWO_SIDED|95.0|0.143|1.365|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||1.365|0.143|0.1561
70939563|NCT01183013|141379751|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.368||||0.0146||95.0|0.165|0.821|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||0.821|0.165|0.0146
70939564|NCT01183013|141379751|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.238||||0.0009||95.0|0.102|0.557|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||0.557|0.102|0.0009
70939565|NCT01183013|141379751|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.141||||0.0002||95.0|0.05|0.397|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||0.397|0.050|0.0002
71071583|NCT02783729|141651745|SUPERIORITY||LSM Difference|-15.03|STANDARD_ERROR_OF_MEAN|2.542|<|0.0001|TWO_SIDED|95.0|-20.01|-10.05||Based on MMRM model with factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline WASO as a covariate.|MMRM|||WASO, Days 1/2: Zolpidem ER, Lemborexant 10 mg||-10.05|-20.01|< 0.0001
71114414|NCT02370537|141737031|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.6|||||TWO_SIDED|90.0|0.42|0.84|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.84|0.42|
71114415|NCT02370537|141737031|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.7|||||TWO_SIDED|90.0|0.54|0.9|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.90|0.54|
71114416|NCT00066703|141737054|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.717||||0.0002|TWO_SIDED|95.0|0.602|0.855|||Log Rank||T+OFS is the reference group in the estimation of the hazard ratio.|||0.855|0.602|.0002
71114417|NCT00066703|141737055|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.664|||<|0.0001|TWO_SIDED|95.0|0.548|0.804|||Log Rank||T+OFS is the reference group for the estimation of the hazard ratio.|||.804|.548|<.0001
71114418|NCT00066703|141737056|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.777||||0.02|TWO_SIDED|95.0|0.624|0.967|||Log Rank||T+OFS was the reference group in the estimation of the hazard ratio|||0.967|0.624|0.02
71114419|NCT00066703|141737057|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.84|TWO_SIDED|95.0|0.79|1.22|||Log Rank||T+OFS was the reference group in the estimation of the hazard ratio|||1.22|0.79|0.84
71114420|NCT01696968|141737058|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.91|1.07|||Poisson regression|||||1.07|0.91|
71114421|NCT01696968|141737060|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.95|1.0|||Poisson regression|||||1.00|0.95|
71114422|NCT01696968|141737062|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.98|1.12|||Poisson regression|||||1.12|0.98|
71114423|NCT01696968|141737066|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.91|1.07|||Poisson regression|||||1.07|0.91|
70939566|NCT02105688|141379763|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided exact test|||A one-sided exact test was used to test the null hypothesis, which was that the SVR12 rate for the ITA was less than 67% (historical reference rate derived from NCT01667731). The p-value was based on a one-sided exact test for a binomial proportion. A one-sided p-value \<0.025 supports a conclusion that the true SVR12 is \>67%.||||<0.001
70939567|NCT02105688|141379764|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.2|||||TWO_SIDED|95.0|-8.3|10.0||||||Categorical AE parameters were assessed via point estimates with 95% confidence intervals provided for between-treatment differences in the percentage of participants with events using the Miettinen and Nurminen method, an unconditional, asymptotic method.||10.0|-8.3|
71114424|NCT01751906|141737133|SUPERIORITY|||||||0.9256|||||||Chi-squared|||||||0.9256
70939568|NCT02105688|141379765|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|-0.5|||||TWO_SIDED|95.0|-5.0|1.9||||||Categorical AE parameters were assessed via point estimates with 95% confidence intervals provided for between-treatment differences in the percentage of participants with events using the Miettinen and Nurminen method, an unconditional, asymptotic method.||1.9|-5.0|
70852935|NCT00797966|141194657|SUPERIORITY_OR_OTHER|||||||0.6105||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||||0.6105
70941971|NCT01524887|141384233|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|0.0||||0.981||95.0|-2.0|2.0|||Mixed Models Analysis|||||2.0|-2.0|0.981
71114425|NCT01751906|141737134|SUPERIORITY|||||||0.504|||||||Fisher Exact|||||||0.5040
71114426|NCT01751906|141737135|SUPERIORITY|||||||0.2126|||||||Fisher Exact|||||||0.2126
70852936|NCT00797966|141194657|SUPERIORITY_OR_OTHER|||||||0.0709||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||||0.0709
71114427|NCT01751906|141737162|SUPERIORITY|||||||0.0665|||||||Chi-squared|||||||0.0665
71114428|NCT04925076|141737186|SUPERIORITY|||||||0.92|||||||ANOVA|F(1,108)=.01||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the condition X family history X sex interaction.||||.92
71114429|NCT04925076|141737186|SUPERIORITY|||||||0.92|||||||ANOVA|F(1,108) = .01||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the condition X sex interaction.||||.92
71114430|NCT04925076|141737186|SUPERIORITY|||||||0.61|||||||Chi-squared|F(1,108) = 0.27||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the condition X family history interaction.||||.61
71114431|NCT04925076|141737186|SUPERIORITY|||||||0.01|||||||ANOVA|F(1,108) = 6.75||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the family history X sex interaction.||||.01
71114432|NCT04925076|141737186|SUPERIORITY|||||||0.05|||||||ANOVA|F(1,108) = 3.83||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the main effect of condition.||||.05
70939569|NCT00887471|141379776|SUPERIORITY_OR_OTHER|||||||0.59||||||A priori threshold for statistical significance was P\<.05.|Mixed Models Analysis|||The relationship of surgical group with AHI change was evaluated by constructing a mixed linear model (MLM). The dependent variable was the logarithm of the ratio of postoperative AHI score to preoperative AHI score; this transformation was chosen in order to minimize skew of model residuals. Surgical group was introduced as a fixed factor; subject pairs constituted levels of a random blocking) factor.||||.590
70939570|NCT00887471|141379776|SUPERIORITY_OR_OTHER|||||||0.022||||||P value for the variances. The a priori threshold for statistical significance was P \< .05.|Mixed Models Analysis|||A mixed linear model was constructed as described above. Variance was estimated separately for each group.||||.022
70939571|NCT00887471|141379777|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||The relationship of surgical group with postoperative AHI ≤ 5 was evaluated by exact conditional logistic regression, predicting AHI ≤ 5 from surgical group with subject pairs as strata.||||1.00
70939572|NCT05878522|141379783|OTHER||LS Mean difference|11.73|||||TWO_SIDED|90.0|8.89|14.58||||||3- hours post-dose||14.58|8.89|
70939573|NCT05878522|141379783|OTHER||LS Mean difference|11.35|||||TWO_SIDED|90.0|8.5|14.2||||||4-hours post-dose||14.20|8.50|
70939574|NCT05878522|141379783|OTHER||LS Mean difference|8.35||||||90.0|5.51|11.2||||||5-hours post-dose||11.20|5.51|
71114433|NCT04925076|141737186|SUPERIORITY|||||||0.003|||||||ANOVA|F(1,108) = 9.53||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the main effect of family history.||||.003
71114434|NCT04925076|141737186|SUPERIORITY|||||||0.12|||||||ANOVA|F(1,108) = 2.41||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the main effect of sex.||||.12
71114435|NCT04925076|141737187|SUPERIORITY|||||||0.38|||||||ANOVA|F(1,107) = 0.78||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the condition X family history X sex interaction.||||.38
70939575|NCT02252172|141379784|SUPERIORITY||Hazard Ratio (HR)|0.56|||<|0.0001|TWO_SIDED|95.0|0.43|0.73|||Log Rank|||||0.73|0.43|<0.0001
70939576|NCT02389894|141379810|SUPERIORITY||Risk Difference (RD)|6.9||||0.22|TWO_SIDED|95.0|-4.2|17.9|||Chi-squared|The primary end point analysis used an iterative hot-deck multiple imputation approach, assuming a nonignorable missing data mechanism.|The absolute difference in the percentage of patients with freedom from clinical or radiographic central nervous system (CNS) infarction was computed as Embol-x minus control|A sample size of 165 patients in each group ensured that each comparison had a power of approximately 90% to detect a between-group difference of 17.5% from an assumed control rate of 50% in the incidence of postoperative CNS infarcts. A single interim analysis was prespecified and performed. Based on the recommendation of the DSMB, randomization but not follow-up was halted due to low conditional power of observing any between-group differences for the primary endpoint.||17.9|-4.2|0.22
70939577|NCT02389894|141379810|SUPERIORITY||Risk Difference (RD)|1.3||||0.84|TWO_SIDED|95.0|-11.2|13.8||The primary end point analysis used an iterative hot-deck multiple imputation approach, assuming a nonignorable missing data mechanism.|Chi-squared||The absolute difference in the percentage of patients with freedom from clinical or radiographic central nervous system (CNS) infarction was computed as Cardiogard minus control.|A sample size of 165 patients in each group ensured that each comparison had a power of approximately 90% to detect a between-group difference of 17.5% from an assumed control rate of 50% in the incidence of postoperative CNS infarcts. A single interim analysis was prespecified and performed. Based on the recommendation of the DSMB, randomization but not follow-up was halted due to low conditional power of observing any between-group differences for the primary endpoint.||13.8|-11.2|0.84
71114436|NCT04925076|141737187|SUPERIORITY|||||||0.27|||||||ANOVA|F(1,107) = 0.27||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the condition X sex interaction.||||.27
70939578|NCT02389894|141379811|SUPERIORITY||Risk Difference (RD)|9.7||||0.08|TWO_SIDED|95.0|-1.2|20.5|||Chi-squared||The absolute difference was computed as Embol-x minus control|||20.5|-1.2|0.08
70939579|NCT02389894|141379811|SUPERIORITY||Risk Difference (RD)|-2.8||||0.61|TWO_SIDED|95.0|-13.5|7.9|||Chi-squared||The absolute difference was computed as Cardiogard minus control|||7.9|-13.5|0.61
71114437|NCT04925076|141737187|SUPERIORITY|||||||0.7|||||||ANOVA|F(1,107) = 0.15||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the condition X family history interaction.||||.70
70939580|NCT00145496|141379832|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7177||95.0||||The test of hypothesis was a 2-tailed test with alpha=0.05 (0.049 to adjust for one interim analysis).|Mixed Model for Repeated Measurements|||The null hypothesis was that there was no difference in change from baseline in NSA Scale total score between asenapine and olanzapine at Day 182.||||0.7177
71114438|NCT04925076|141737187|SUPERIORITY|||||||0.05|||||||ANOVA|F(1,107) = 3.87||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the family history X sex interaction.||||.05
71114439|NCT04925076|141737187|SUPERIORITY|||||||0.03|||||||ANOVA|F(1,107) = 5.18||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the main effect of condition.||||.03
71114440|NCT04925076|141737187|SUPERIORITY|||||||0.14|||||||ANOVA|F(1,107) = 2.24||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the main effect of family history.||||.14
71114441|NCT04925076|141737187|SUPERIORITY||||||<|0.001|||||||ANOVA|F(1,107) = 17.25||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the main effect of sex.||||<.001
71114442|NCT04925076|141737188|SUPERIORITY|||||||0.83|||||||ANOVA|F(1,107) = 0.05||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the condition X family history X sex interaction.||||.83
71114443|NCT04925076|141737188|SUPERIORITY|||||||0.12|||||||ANOVA|F(1,107) = 2.43||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the condition X sex interaction.||||.12
71114444|NCT04925076|141737188|SUPERIORITY|||||||0.25|||||||ANOVA|F(1,107) = 1.36||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the condition X family history interaction.||||.25
71114445|NCT04925076|141737188|SUPERIORITY|||||||0.58|||||||ANOVA|F(1,107) = 0.31||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the family history X sex interaction.||||.58
71114446|NCT04925076|141737188|SUPERIORITY|||||||0.9|||||||ANOVA|F(1,107) = 0.02||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of condition.||||.90
71114447|NCT04925076|141737188|SUPERIORITY|||||||0.95|||||||ANOVA|F(1,107) = .004||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of family history.||||.95
71114448|NCT04925076|141737188|SUPERIORITY|||||||0.68|||||||ANOVA|F(1,107) = 0.17||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of sex.||||.68
71114449|NCT04925076|141737189|SUPERIORITY|||||||0.36|||||||ANOVA|F(1,107) = 0.83||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the condition X family history X sex interaction.||||.36
71114450|NCT04925076|141737189|SUPERIORITY|||||||0.24|||||||ANOVA|F(1,108) = 1.41||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the condition X sex interaction.||||.24
71114451|NCT04925076|141737189|SUPERIORITY|||||||0.6|||||||ANOVA|F(1,108) = 0.28||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the condition X family history interaction.||||.60
71114452|NCT04925076|141737189|SUPERIORITY|||||||0.99|||||||ANOVA|F(1,108) = 0.00||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the family history X sex interaction.||||.99
71114453|NCT04925076|141737189|SUPERIORITY||||||<|0.001|||||||ANOVA|F(1,108) = 139.63||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of condition.||||<.001
71114454|NCT04925076|141737189|SUPERIORITY|||||||0.84|||||||ANOVA|F(1,108) = 0.04||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of family history.||||.84
70852937|NCT00797966|141194657|SUPERIORITY_OR_OTHER|||||||0.9574||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||||0.9574
71114455|NCT04925076|141737189|SUPERIORITY|||||||0.59|||||||ANOVA|F(1,108) = 0.30||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of sex.||||.59
71114456|NCT04925076|141737190|SUPERIORITY|||||||0.66|||||||ANOVA|F(1,93)=0.19||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.66
71114457|NCT04925076|141737190|SUPERIORITY|||||||0.41|||||||ANOVA|F(1,93)=0.69||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the condition X sex interaction.||||.41
71114458|NCT04925076|141737190|SUPERIORITY|||||||0.39|||||||ANOVA|F(1,93)=0.74||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the condition X family history interaction.||||.39
71114459|NCT04925076|141737190|SUPERIORITY|||||||0.22|||||||ANOVA|F(1,93)=1.54||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the family history X sex interaction.||||.22
71114460|NCT04925076|141737190|SUPERIORITY|||||||0.06|||||||ANOVA|F(1,93)=3.64||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the main effect of condition.||||.06
71114461|NCT04925076|141737190|SUPERIORITY|||||||0.99|||||||ANOVA|F(1,93)=0.000||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the main effect of family history.||||.99
71114462|NCT04925076|141737190|SUPERIORITY|||||||0.09|||||||ANOVA|F(1,93)=2.88||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the main effect of sex.||||.09
71114463|NCT04925076|141737191|SUPERIORITY|||||||0.55|||||||ANOVA|F(1,93)=0.36||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hypothalamus activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.55
71114464|NCT04925076|141737191|SUPERIORITY|||||||0.36|||||||ANOVA|F(1,93)=0.84||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hypothalamus activation. Here we report the results of the analysis of the condition X sex interaction.||||.36
71114465|NCT04925076|141737191|SUPERIORITY|||||||0.36|||||||ANOVA|F(1,93)=0.84||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hypothalamus activation. Here we report the results of the analysis of the condition X family history interaction.||||.36
71114466|NCT04925076|141737191|SUPERIORITY|||||||0.17|||||||ANOVA|F(1,93)=1.93||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hypothalamus activation. Here we report the results of the analysis of the family history X sex interaction.||||.17
70852938|NCT00797966|141194657|SUPERIORITY_OR_OTHER|||||||0.231||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||||0.2310
70852939|NCT00797966|141194657|SUPERIORITY_OR_OTHER|||||||0.0672||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||||0.0672
71071584|NCT02783729|141651745|SUPERIORITY||LSM Difference|-7.72|STANDARD_ERROR_OF_MEAN|2.876|=|0.0073|TWO_SIDED|95.0|-13.36|-2.08||Based on MMRM model with factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline WASO as a covariate.|MMRM|||WASO, Days 29/30: Zolpidem ER, Lemborexant 5 mg||-2.08|-13.36|= 0.0073
71071585|NCT02783729|141651745|SUPERIORITY||LSM Difference|-9.1|STANDARD_ERROR_OF_MEAN|2.883|=|0.0016|TWO_SIDED|95.0|-14.75|-3.45|||MMRM|||WASO, Days 29/30: Zolpidem ER, Lemborexant 10 mg||-3.45|-14.75|= 0.0016
71071586|NCT02783729|141651745|SUPERIORITY||LSM Difference|10.25|STANDARD_ERROR_OF_MEAN|3.094|=|0.001|TWO_SIDED|95.0|4.18|16.32||Based on MMRM model with factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline TST as a covariate.|MMRM|||TST, Days 1/2: Zolpidem ER, Lemborexant 5 mg||16.32|4.18|= 0.001
71071587|NCT02783729|141651745|SUPERIORITY||LSM Difference|23.1|STANDARD_ERROR_OF_MEAN|3.085|<|0.0001|TWO_SIDED|95.0|17.04|29.15||Based on MMRM model with factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline TST as a covariate.|MMRM|||TST, Days 1/2: Zolpidem ER, Lemborexant 10 mg||29.15|17.04|< 0.0001
71071588|NCT02783729|141651745|SUPERIORITY||LSM Difference|19.41|STANDARD_ERROR_OF_MEAN|3.457|<|0.0001|TWO_SIDED|95.0|12.63|26.2||Based on MMRM model with factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline TST as a covariate.|MMRM|||TST, Days 29/30: Zolpidem ER, Lemborexant 5 mg||26.2|12.63|< 0.0001
71071589|NCT02783729|141651745|SUPERIORITY||LSM Difference|24.1|STANDARD_ERROR_OF_MEAN|3.456|<|0.0001|TWO_SIDED|95.0|17.32|30.88||Based on MMRM model with factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline TST as a covariate.|MMRM|||TST, Days 29/30: Zolpidem ER, Lemborexant 10 mg||30.88|17.32|< 0.0001
71071590|NCT02783729|141651746|SUPERIORITY||LSGM Ratio|0.898|||=|0.0122|TWO_SIDED|95.0|0.825|0.977||Based on MMRM model model with log transformation of sSOL and factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, First 7 nights: Zolpidem ER, Lemborexant 5 mg||0.977|0.825|= 0.0122
71071591|NCT02783729|141651746|SUPERIORITY||LSGM Ratio|0.83|||<|0.0001|TWO_SIDED|95.0|0.763|0.902||Based on MMRM model model with log transformation of sSOL and factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, First 7 nights: Zolpidem ER, Lemborexant 10 mg||0.902|0.763|< 0.0001
71071592|NCT02783729|141651746|SUPERIORITY||LSGM Ratio|0.882|||=|0.0176|TWO_SIDED|95.0|0.796|0.978||Based on MMRM model model with log transformation of sSOL and factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, Last 7 nights: Zolpidem ER, Lemborexant 5 mg||0.978|0.796|= 0.0176
71071593|NCT02783729|141651746|SUPERIORITY||LSGM Ratio|0.811|||<|0.0001|TWO_SIDED|95.0|0.732|0.899||Based on MMRM model model with log transformation of sSOL and with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, Last 7 nights: Zolpidem ER, Lemborexant 10 mg||0.899|0.732|< 0.0001
71071594|NCT02783729|141651746|SUPERIORITY||LSM Difference|8.12|STANDARD_ERROR_OF_MEAN|4.484|=|0.0706|TWO_SIDED|95.0|-0.68|16.91||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, First 7 nights: Zolpidem ER, Lemborexant 5 mg||16.91|-0.68|= 0.0706
71114467|NCT04925076|141737191|SUPERIORITY|||||||0.55|||||||ANOVA|F(1,93)=0.36||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hypothalamus activation. Here we report the results of the analysis of the main effect of condition.||||.55
71114468|NCT04925076|141737191|SUPERIORITY|||||||0.43|||||||ANOVA|F(1,93)=0.63||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hypothalamus activation. Here we report the results of the analysis of the main effect of family history.||||.43
70852940|NCT00797966|141194657|SUPERIORITY_OR_OTHER|||||||0.8441||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||||0.8441
70852941|NCT00797966|141194657|SUPERIORITY_OR_OTHER|||||||0.6741||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||||0.6741
70852942|NCT00797966|141194657|SUPERIORITY_OR_OTHER|||||||0.0183||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||||0.0183
71071595|NCT02783729|141651746|SUPERIORITY||LSM Difference|-5.81|STANDARD_ERROR_OF_MEAN|4.481|=|0.1949|TWO_SIDED|95.0|-14.61|2.98||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, First 7 nights: Zolpidem ER, Lemborexant 10 mg||2.98|-14.61|= 0.1949
71071596|NCT02783729|141651746|SUPERIORITY||LSM Difference|14.45|STANDARD_ERROR_OF_MEAN|5.241|=|0.0059|TWO_SIDED|95.0|4.16|24.73||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, Last 7 nights: Zolpidem ER, Lemborexant 5 mg||24.73|4.16|= 0.0059
71071597|NCT02783729|141651746|SUPERIORITY||LSM Difference|5.36|STANDARD_ERROR_OF_MEAN|5.241|=|0.3064|TWO_SIDED|95.0|-4.92|15.65||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, Last 7 nights: Zolpidem ER, Lemborexant 10 mg||15.65|-4.92|= 0.3064
71071598|NCT02783729|141651746|SUPERIORITY||LSM Difference|-6.57|STANDARD_ERROR_OF_MEAN|5.325|=|0.2174|TWO_SIDED|95.0|-17.02|3.88||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baselines sTST as a covariate.|MMRM|||sTST, First 7 nights: Zolpidem ER, Lemborexant 5 mg||3.88|-17.02|= 0.2174
71071599|NCT02783729|141651746|SUPERIORITY||LSM Difference|8.88|STANDARD_ERROR_OF_MEAN|5.313|=|0.0949|TWO_SIDED|95.0|-1.55|19.31||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sTST as a covariate.|MMRM|||sTST, First 7 nights: Zolpidem ER, Lemborexant 10 mg||19.31|-1.55|= 0.0949
71071600|NCT02783729|141651746|SUPERIORITY||LSM Difference|-6.82|STANDARD_ERROR_OF_MEAN|6.207|=|0.2718|TWO_SIDED|95.0|-19.01|5.36||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sTST as a covariate.|MMRM|||sTST, Last 7 nights: Zolpidem ER, Lemborexant 5 mg||5.36|-19.01|= 0.2718
71071601|NCT02783729|141651746|SUPERIORITY||LSM Difference|7.43|STANDARD_ERROR_OF_MEAN|6.206|=|0.2317|TWO_SIDED|95.0|-4.75|19.61||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sTST as a covariate.|MMRM|||sTST, Last 7 nights: Zolpidem ER, Lemborexant 10 mg||19.61|-4.75|= 0.2317
71114469|NCT04925076|141737191|SUPERIORITY|||||||0.33|||||||ANOVA|F(1,93)=0.96||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the main effect of sex.||||.33
71114470|NCT04925076|141737192|SUPERIORITY|||||||0.34|||||||ANOVA|F(1,93)=0.34||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.34
71114471|NCT04925076|141737192|SUPERIORITY|||||||0.88|||||||ANOVA|F(1,93)=0.02||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex activation. Here we report the results of the analysis of the condition X sex interaction.||||.88
71114472|NCT04925076|141737192|SUPERIORITY|||||||0.56|||||||ANOVA|F(1,93)=0.34||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex activation. Here we report the results of the analysis of the condition X family history interaction.||||.56
71071602|NCT02783729|141651747|SUPERIORITY||LSM Difference|-1.37|STANDARD_ERROR_OF_MEAN|1.063|=|0.1963|TWO_SIDED|95.0|-3.46|0.71||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, First 7 nights: Zolpidem ER, Lemborexant 5 mg||0.71|-3.46|= 0.1963
71071603|NCT02783729|141651747|SUPERIORITY|Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate|LSM Difference|1.7|STANDARD_ERROR_OF_MEAN|1.06|=|0.1093|TWO_SIDED|95.0|-0.38|3.78|||MMRM|||sSE, First 7 nights: Zolpidem ER, Lemborexant 10 mg||3.78|-0.38|= 0.1093
71071604|NCT02783729|141651747|SUPERIORITY||LSM Difference|-1.53|STANDARD_ERROR_OF_MEAN|1.247|=|0.2196|TWO_SIDED|95.0|-3.98|0.92||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, Last 7 nights: Zolpidem ER, Lemborexant 5 mg||0.92|-3.98|= 0.2196
71071605|NCT02783729|141651747|SUPERIORITY||LSM Difference|1.05|STANDARD_ERROR_OF_MEAN|1.246|=|0.4013|TWO_SIDED|95.0|-1.4|3.49||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, Last 7 nights: Zolpidem ER, Lemborexant 10 mg||3.49|-1.4|= 0.4013
71114473|NCT04925076|141737192|SUPERIORITY|||||||0.9|||||||ANOVA|F(1,93)=0.02||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex activation. Here we report the results of the analysis of the family history X sex interaction.||||.90
71114474|NCT04925076|141737192|SUPERIORITY|||||||0.45|||||||ANOVA|F(1,93)=0.59||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex activation. Here we report the results of the analysis of the main effect of condition.||||.45
71071606|NCT02783729|141651748|SUPERIORITY||LSGM Ratio|0.85|||=|0.0092|TWO_SIDED|95.0|0.752|0.961||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS: Placebo, Lemborexant 5 mg||0.961|0.752|= 0.0092
70852943|NCT00797966|141194658|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.49||||0.3007|TWO_SIDED|95.0|0.12|1.93||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.93|0.12|0.3007
71071607|NCT02783729|141651748|SUPERIORITY||LSGM Ratio|0.795|||=|0.0002|TWO_SIDED|95.0|0.704|0.899||Based on MMRM model with factors of age group, region, treatment, visit (Days1/2), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS: Placebo, Lemborexant 10 mg||0.899|0.704|= 0.0002
70852944|NCT00797966|141194658|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.94||||0.8812|TWO_SIDED|95.0|0.42|2.1||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||2.10|0.42|0.8812
71071608|NCT02783729|141651748|SUPERIORITY||LSM Difference|-33.4|STANDARD_ERROR_OF_MEAN|2.711|<|0.0001|TWO_SIDED|95.0|-38.71|-28.09||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effect, and the baseline WASO as a covariate.|MMRM|||WASO: Placebo, Lemborexant 5 mg||-28.09|-38.71|< 0.0001
71071609|NCT02783729|141651748|SUPERIORITY||LSM Difference|-42.27|STANDARD_ERROR_OF_MEAN|2.705|<|0.0001|TWO_SIDED|95.0|-47.57|-36.97||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effect, and the baseline WASO as a covariate.|MMRM|||WASO: Placebo, Lemborexant 10 mg||-36.97|-47.57|< 0.0001
71071610|NCT02783729|141651748|SUPERIORITY||LSM Difference|-21.66|STANDARD_ERROR_OF_MEAN|2.221|<|0.0001|TWO_SIDED|95.0|-26.01|-17.3||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline WASO2H as a covariate.|MMRM|||WASO2H: Placebo, Lemborexant 5 mg||-17.3|-26.01|< 0.0001
71071611|NCT02783729|141651748|SUPERIORITY||LSM Difference|-28.33|STANDARD_ERROR_OF_MEAN|2.219|<|0.0001|TWO_SIDED|95.0|-32.68|-23.98||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline WASO2H as a covariate.|MMRM|||WASO2H: Placebo, Lemborexant 10 mg||-23.98|-32.68|< 0.0001
71071612|NCT02783729|141651748|SUPERIORITY||LSM Difference|44.05|STANDARD_ERROR_OF_MEAN|3.291|<|0.0001|TWO_SIDED|95.0|37.59|50.51||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effect, and the baseline TST as a covariate.|MMRM|||TST: Placebo, Lemborexant 5 mg||50.51|37.59|< 0.0001
71071613|NCT02783729|141651748|SUPERIORITY||LSM Difference|56.9|STANDARD_ERROR_OF_MEAN|3.284|<|0.0001|TWO_SIDED|95.0|50.46|63.34||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effect, and the baseline TST as a covariate.|MMRM|||TST: Placebo, Lemborexant 10 mg||63.34|50.46|< 0.0001
71071614|NCT02783729|141651749|SUPERIORITY||LSM Difference|9.01|STANDARD_ERROR_OF_MEAN|0.666|<|0.0001|TWO_SIDED|95.0|7.7|10.31||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline SE as a covariate.|MMRM|||SE: Placebo, Lemborexant 5 mg||10.31|7.7|< 0.0001
71071615|NCT02783729|141651749|SUPERIORITY||LSM Difference|11.6|STANDARD_ERROR_OF_MEAN|0.664|<|0.0001|TWO_SIDED|95.0|10.3|12.9||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effect, and the baseline SE as a covariate.|MMRM|||SE: Placebo, Lemborexant 10 mg||12.9|10.3|< 0.0001
71071616|NCT02783729|141651750|SUPERIORITY||LSM Difference|-16.41|STANDARD_ERROR_OF_MEAN|2.457|<|0.0001|TWO_SIDED|95.0|-21.23|-11.6||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline WASO2H as a covariate.|MMRM|||WASO2H: Placebo, Lemborexant 5 mg||-11.6|-21.23|< 0.0001
71071617|NCT02783729|141651750|SUPERIORITY||LSM Difference|-17.76|STANDARD_ERROR_OF_MEAN|2.451|<|0.0001|TWO_SIDED|95.0|-22.57|-12.96||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline WASO2H as a covariate.|MMRM|||WASO2H: Placebo, Lemborexant 10 mg||-12.96|-22.57|< 0.0001
71071618|NCT02783729|141651750|SUPERIORITY||LSM Difference|34.16|STANDARD_ERROR_OF_MEAN|3.673|<|0.0001|TWO_SIDED|95.0|26.95|41.36||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline TST as a covariate.|MMRM|||TST: Placebo, Lemborexant 5 mg||41.36|26.95|< 0.0001
71071619|NCT02783729|141651750|SUPERIORITY||LSM Difference|38.85|STANDARD_ERROR_OF_MEAN|3.672|<|0.0001|TWO_SIDED|95.0|31.64|46.05||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline TST as a covariate.|MMRM|||TST: Placebo, Lemborexant 10 mg||46.05|31.64|< 0.0001
71114475|NCT04925076|141737192|SUPERIORITY|||||||0.85|||||||ANOVA|F(1,93)=0.04||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex activation. Here we report the results of the analysis of the main effect of family history.||||.85
70939581|NCT00145496|141379833|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0565||95.0||||The test of hypothesis was a 2-tailed test with alpha=0.025 nominal significance using the Bonferroni adjustment to account for multiplicity of the key secondary comparisons.|Mixed Model for Repeated Measurements|||The null hypothesis was that there was no difference in change from baseline in QLS total score between asenapine and olanzapine at Day 182.||||0.0565
71071620|NCT02783729|141651751|SUPERIORITY||LSGM Ratio|0.815|||<|0.0001|TWO_SIDED|95.0|0.745|0.891||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, First 7 nights: Placebo, Lemborexant 5 mg||0.891|0.745|< 0.0001
71071621|NCT02783729|141651751|SUPERIORITY||LSGM Ratio|0.753|||<|0.0001|TWO_SIDED|95.0|0.689|0.823||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, First 7 nights: Placebo, Lemborexant 10 mg||0.823|0.689|< 0.0001
71071622|NCT02783729|141651751|SUPERIORITY||LSGM Ratio|0.75|||<|0.0001|TWO_SIDED|95.0|0.671|0.837||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, Last 7 nights: Placebo, Lemborexant 5 mg||0.837|0.671|< 0.0001
71071623|NCT02783729|141651751|SUPERIORITY||LSGM Ratio|0.689|||<|0.0001|TWO_SIDED|95.0|0.618|0.769||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, Last 7 nights: Placebo, Lemborexant 10 mg||0.769|0.618|< 0.0001
70852945|NCT00797966|141194658|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.32||||0.0553|TWO_SIDED|95.0|0.1|1.07||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.07|0.10|0.0553
70852946|NCT00797966|141194658|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.78||||0.6051|TWO_SIDED|95.0|0.3|2.05||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||2.05|0.30|0.6051
71071624|NCT02783729|141651751|SUPERIORITY||LSM Difference|-12.41|STANDARD_ERROR_OF_MEAN|4.764|=|0.0093|TWO_SIDED|95.0|-21.76|-3.06||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, First 7 nights: Placebo, Lemborexant 5 mg||-3.06|-21.76|= 0.0093
71071625|NCT02783729|141651751|SUPERIORITY||LSM Difference|-26.34|STANDARD_ERROR_OF_MEAN|4.762|<|0.0001|TWO_SIDED|95.0|-35.68|-16.99||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, First 7 nights: Placebo, Lemborexant 10 mg||-16.99|-35.68|< 0.0001
71071626|NCT02783729|141651751|SUPERIORITY||LSM Difference|-11.49|STANDARD_ERROR_OF_MEAN|5.573|=|0.0396|TWO_SIDED|95.0|-22.42|-0.55||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, Last 7 nights: Placebo, Lemborexant 5 mg||-0.55|-22.42|= 0.0396
71071627|NCT02783729|141651751|SUPERIORITY||LSM Difference|-20.57|STANDARD_ERROR_OF_MEAN|5.574|=|0.0002|TWO_SIDED|95.0|-31.51|-9.63||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, Last 7 nights: Placebo, Lemborexant 10 mg||-9.63|-31.51|= 0.0002
71071628|NCT02783729|141651751|SUPERIORITY||LSM Difference|19.05|STANDARD_ERROR_OF_MEAN|5.619|=|0.0007|TWO_SIDED|95.0|8.03|30.08||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baselines sTST as a covariate.|MMRM|||sTST, First 7 nights: Placebo, Lemborexant 5 mg||30.08|8.03|= 0.0007
71071629|NCT02783729|141651751|SUPERIORITY||LSM Difference|34.51|STANDARD_ERROR_OF_MEAN|5.609|<|0.0001|TWO_SIDED|95.0|23.5|45.52||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baselines sTST as a covariate.|MMRM|||sTST, First 7 nights: Placebo, Lemborexant 10 mg||45.52|23.5|< 0.0001
71071630|NCT02783729|141651751|SUPERIORITY||LSM Difference|23.57|STANDARD_ERROR_OF_MEAN|6.565|=|0.0003|TWO_SIDED|95.0|10.68|36.45||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sTST as a covariate.|MMRM|||sTST, Last 7 nights: Placebo, Lemborexant 5 mg||36.45|10.68|= 0.0003
71071631|NCT02783729|141651751|SUPERIORITY||LSM Difference|37.82|STANDARD_ERROR_OF_MEAN|6.565|<|0.0001|TWO_SIDED|95.0|24.94|50.71||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sTST as a covariate.|MMRM|||sTST, Last 7 nights: Placebo, Lemborexant 10 mg||50.71|24.94|< 0.0001
71071632|NCT02783729|141651752|SUPERIORITY||LSM Difference|3.76|STANDARD_ERROR_OF_MEAN|1.122|=|0.0008|TWO_SIDED|95.0|1.56|5.97||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, First 7 nights: Placebo, Lemborexant 5 mg||5.97|1.56|= 0.0008
71071633|NCT02783729|141651752|SUPERIORITY||LSM Difference|6.84|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|4.64|9.04||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, First 7 nights: Placebo, Lemborexant 10 mg||9.04|4.64|< 0.0001
71071634|NCT02783729|141651752|SUPERIORITY||LSM Difference|4.61|STANDARD_ERROR_OF_MEAN|1.319|=|0.0005|TWO_SIDED|95.0|2.02|7.19||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, Last 7 nights: Placebo, Lemborexant 5 mg||7.19|2.02|= 0.0005
71071635|NCT02783729|141651752|SUPERIORITY||LSM Difference|7.18|STANDARD_ERROR_OF_MEAN|1.319|<|0.0001|TWO_SIDED|95.0|4.6|9.77||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, Last 7 nights: Placebo, Lemborexant 10 mg||9.77|4.6|< 0.0001
71071636|NCT02783729|141651753|SUPERIORITY||Difference of Percentage|0.41|||=|0.9028|TWO_SIDED|95.0|-6.22|7.04||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 1/2: Placebo, Lemborexant 5 mg||7.04|-6.22|= 0.9028
71071637|NCT02783729|141651753|SUPERIORITY||Difference of Percentage|2.49|||=|0.4699|TWO_SIDED|95.0|-4.2|9.18||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 1/2: Placebo, Lemborexant 10 mg||9.18|-4.2|= 0.4699
71071638|NCT02783729|141651753|SUPERIORITY||Difference of Percentage|5.58|||=|0.0566|TWO_SIDED|95.0|-0.14|11.31|||Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel test stratified by age group.||LPS, Days 1/2: Zolpidem ER, Lemborexant 5 mg||11.31|-0.14|= 0.0566
71071639|NCT02783729|141651753|SUPERIORITY||Difference of Percentage|7.57|||=|0.0122|TWO_SIDED|95.0|1.71|13.44||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 1/2: Zolpidem ER, Lemborexant 10 mg||13.44|1.71|= 0.0122
71071640|NCT02783729|141651753|SUPERIORITY||Difference of Percentage|4.42|||=|0.2176|TWO_SIDED|95.0|-2.5|11.34||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 29/30: Placebo, Lemborexant 5 mg||11.34|-2.5|= 0.2176
71071641|NCT02783729|141651753|SUPERIORITY||Difference of Percentage|6.47|||=|0.0773|TWO_SIDED|95.0|-0.55|13.49||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 29/30: Placebo, Lemborexant 10 mg||13.49|-0.55|= 0.0773
71071642|NCT02783729|141651753|SUPERIORITY||Difference of Percentage|8.85|||=|0.0054|TWO_SIDED|95.0|2.68|15.02||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 29/30: Zolpidem ER, Lemborexant 5 mg||15.02|2.68|= 0.0054
70852947|NCT00797966|141194658|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.92||||0.8264|TWO_SIDED|95.0|0.46|1.85||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||1.85|0.46|0.8264
71071643|NCT02783729|141651753|SUPERIORITY||Difference of Percentage|10.89|||=|0.0008|TWO_SIDED|95.0|4.61|17.17||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 29/30: Zolpidem ER, Lemborexant 10 mg||17.17|4.61|= 0.0008
71071644|NCT02783729|141651753|SUPERIORITY||Difference of Percentage|6.9|||=|0.003|TWO_SIDED|95.0|2.66|11.14||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, First 7 nights: Placebo, Lemborexant 5 mg||11.14|2.66|= 0.003
71071645|NCT02783729|141651753|SUPERIORITY||Difference of Percentage|7.5|||=|0.0016|TWO_SIDED|95.0|3.19|11.81||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, First 7 nights: Placebo, Lemborexant 10 mg||11.81|3.19|= 0.0016
71071646|NCT02783729|141651753|SUPERIORITY||Difference of Percentage|2.22|||=|0.3643|TWO_SIDED|95.0|-2.56|7.01||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, First 7 nights: Zolpidem, Lemborexant 5 mg||7.01|-2.56|= 0.3643
71071647|NCT02783729|141651753|SUPERIORITY||Difference of Percentage|2.82|||=|0.2553|TWO_SIDED|95.0|-2.02|7.66||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, First 7 nights: Zolpidem, Lemborexant 10 mg||7.66|-2.02|= 0.2553
71071648|NCT02783729|141651753|SUPERIORITY||Difference of Percentage|9.69|||=|0.0016|TWO_SIDED|95.0|3.98|15.4||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, Last 7 nights: Placebo, Lemborexant 5 mg||15.4|3.98|= 0.0016
71071649|NCT02783729|141651753|SUPERIORITY||Difference of Percentage|7.29|||=|0.0128|TWO_SIDED|95.0|1.8|12.79||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, Last 7 nights: Placebo, Lemborexant 10 mg||12.79|1.8|= 0.0128
71071650|NCT02783729|141651753|SUPERIORITY||Difference of Percentage|8.16|||=|0.0051|TWO_SIDED|95.0|2.51|13.81||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, Last 7 nights: Zolpidem ER, Lemborexant 5 mg||13.81|2.51|= 0.0051
71071651|NCT02783729|141651753|SUPERIORITY||Difference of Percentage|5.76|||=|0.0389|TWO_SIDED|95.0|0.34|11.18||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, Last 7nights: Zolpidem ER, Lemborexant 10 mg||11.18|0.34|= 0.0389
71071652|NCT02783729|141651753|SUPERIORITY||Difference of Percentage|34.26|||<|0.0001|TWO_SIDED|95.0|26.46|42.06||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 1/2: Placebo, Lemborexant 5 mg||42.06|26.46|< 0.0001
71071653|NCT02783729|141651753|SUPERIORITY||Difference of Percentage|47.57|||<|0.0001|TWO_SIDED|95.0|40.02|55.13||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 1/2: Placebo, Lemborexant 10 mg||55.13|40.02|< 0.0001
71114476|NCT04925076|141737192|SUPERIORITY|||||||0.64|||||||ANOVA|F(1,93)=0.22||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex. Here we report the results of the analysis of the main effect of sex.||||.64
71114477|NCT04925076|141737193|SUPERIORITY|||||||0.3|||||||ANOVA|F(1,93)=1.07||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.30
71071654|NCT02783729|141651753|SUPERIORITY||Difference of Percentage|4.89|||=|0.2534|TWO_SIDED|95.0|-3.49|13.28||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 1/2: Zolpidem ER, Lemborexant 5 mg||13.28|-3.49|= 0.2534
71071655|NCT02783729|141651753|SUPERIORITY||Difference of Percentage|18.25|||<|0.0001|TWO_SIDED|95.0|10.1|26.4||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO: Days 1/2: Zolpidem ER, Lemborexant 10 mg||26.4|10.1|< 0.0001
71071656|NCT02783729|141651753|SUPERIORITY||Difference of Percentage|22.2|||<|0.0001|TWO_SIDED|95.0|14.06|30.35||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 29/30: Placebo, Lemborexant 5 mg||30.35|14.06|< 0.0001
71071657|NCT02783729|141651753|SUPERIORITY||Difference of Percentage|24.13|||<|0.0001|TWO_SIDED|95.0|16.16|32.1||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 29/30: Placebo, Lemborexant 10 mg||32.1|16.16|< 0.0001
71071658|NCT02783729|141651753|SUPERIORITY||Difference of Percentage|9.59|||=|0.023|TWO_SIDED|95.0|1.36|17.81||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 29/30: Zolpidem ER, Lemborexant 5 mg||17.81|1.36|= 0.023
71071659|NCT02783729|141651753|SUPERIORITY||Difference of Percentage|11.43|||=|0.0058|TWO_SIDED|95.0|3.38|19.48||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 29/30: Zolpidem ER, Lemborexant 10 mg||19.48|3.38|= 0.0058
71071660|NCT02783729|141651753|SUPERIORITY||Difference of Percentage|7.3|||=|0.0222|TWO_SIDED|95.0|1.27|13.33||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, First 7 nights: Placebo, Lemborexant 5||13.33|1.27|= 0.0222
70939582|NCT00145496|141379834|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The test of hypothesis was a 2-tailed test with alpha=0.025 nominal significance using the Bonferroni adjustment to account for multiplicity of the key secondary comparisons.|Mixed Model for Repeated Measurements|||The null hypothesis was that there was no difference in change from baseline in body weight between asenapine and olanzapine at Day 182.||||<0.0001
71071661|NCT02783729|141651753|SUPERIORITY||Difference of Percentage|10.84|||=|0.0013|TWO_SIDED|95.0|4.57|17.11||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, First 7 nights: Placebo, Lemborexant 10 mg||17.11|4.57|= 0.0013
71114478|NCT04925076|141737193|SUPERIORITY|||||||0.11|||||||ANOVA|F(1,93)=2.62||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the condition X sex interaction.||||.11
71071662|NCT02783729|141651753|SUPERIORITY||Difference of Percentage|0.21|||=|0.9495|TWO_SIDED|95.0|-6.17|6.58||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, First 7 nights: Zolpidem ER, Lemborexant 5 mg||6.58|-6.17|= 0.9495
71071663|NCT02783729|141651753|SUPERIORITY||Difference of Percentage|3.72|||=|0.2708|TWO_SIDED|95.0|-2.88|10.32||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO: First 7 nights: Zolpidem ER, Lemborexant 10 mg||10.32|-2.88|= 0.2708
70852948|NCT00797966|141194658|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.06||||0.869|TWO_SIDED|95.0|0.54|2.1||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||2.10|0.54|0.8690
71071664|NCT02783729|141651753|SUPERIORITY||Difference of Percentage|7.91|||=|0.0322|TWO_SIDED|95.0|0.86|14.96||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, Last 7 nights: Placebo, Lemborexant 5 mg||14.96|0.86|= 0.0322
71071665|NCT02783729|141651753|SUPERIORITY||Difference of Percentage|7.69|||=|0.0363|TWO_SIDED|95.0|0.68|14.71||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, Last 7 nights: Placebo, Lemborexant 10 mg||14.71|0.68|= 0.0363
71071666|NCT02783729|141651753|SUPERIORITY||Difference of Percentage|0.05|||=|0.9885|TWO_SIDED|95.0|-7.14|7.24||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, Last 7 nights: Zolpidem ER, Lemborexant 5 mg||7.24|-7.14|= 0.9885
71071667|NCT02783729|141651753|SUPERIORITY||Difference of Percentage|-0.16|||=|0.9651|TWO_SIDED|95.0|-7.31|6.99||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, Last 7 nights: Zolpidem ER, Lemborexant 10 mg||6.99|-7.31|= 0.9651
71071668|NCT02783729|141651754|SUPERIORITY||LSM Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.319|=|0.0006|TWO_SIDED|95.0|-1.73|-0.47||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Placebo, Lemborexant 5 mg||-0.47|-1.73|= 0.0006
71071669|NCT02783729|141651754|SUPERIORITY||LSM Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.32|=|0.0007|TWO_SIDED|95.0|-1.71|-0.46||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Placebo, Lemborexant 10 mg||-0.46|-1.71|= 0.0007
71071670|NCT02783729|141651754|SUPERIORITY||LSM Difference|0.32|STANDARD_ERROR_OF_MEAN|0.301|=|0.2951|TWO_SIDED|95.0|-0.28|0.91||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Zolpidem ER, Lemborexant 5 mg||0.91|-0.28|= 0.2951
71071671|NCT02783729|141651754|SUPERIORITY||LSM Difference|0.33|STANDARD_ERROR_OF_MEAN|0.303|=|0.2744|TWO_SIDED|95.0|-0.26|0.92||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Zolpidem ER, Lemborexant 10 mg||0.92|-0.26|= 0.2744
71071672|NCT02783729|141651755|SUPERIORITY||LSM Difference|-1.26|STANDARD_ERROR_OF_MEAN|1.063|=|0.2348|TWO_SIDED|95.0|-3.35|0.82||Based on ANCOVA model with factors of age group, region, treatment and the baseline FSS as a covariate.|ANCOVA|||Placebo, Lemborexant 5 mg||0.82|-3.35|= 0.2348
71071673|NCT02783729|141651755|SUPERIORITY||LSM Difference|-1.17|STANDARD_ERROR_OF_MEAN|1.067|=|0.2745|TWO_SIDED|95.0|-3.26|0.93||Based on ANCOVA model with factors of age group, region, treatment and the baseline FSS as a covariate.|ANCOVA|||Placebo, Lemborexant 10 mg||0.93|-3.26|= 0.2745
71071674|NCT02783729|141651755|SUPERIORITY||LSM Difference|-0.37|STANDARD_ERROR_OF_MEAN|1.005|=|0.711|TWO_SIDED|95.0|-2.35|1.6||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Zolpidem ER, Lemborexant 5 mg||1.6|-2.35|= 0.711
71071675|NCT02783729|141651755|SUPERIORITY||LSM Difference|-0.27|STANDARD_ERROR_OF_MEAN|1.009|=|0.7854|TWO_SIDED|95.0|-2.26|1.71||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Zolpidem ER, Lemborexant 10 mg||1.71|-2.26|= 0.7854
71071676|NCT02783729|141651756|SUPERIORITY||LSM Difference|30.77|STANDARD_ERROR_OF_MEAN|12.505|=|0.0141|TWO_SIDED|95.0|6.23|55.31||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline POA as a covariate.|MMRM|||POA: Placebo, Lemborexant 5 mg||55.31|6.23|= 0.0141
71071677|NCT02783729|141651756|SUPERIORITY||LSM Difference|39.67|STANDARD_ERROR_OF_MEAN|12.542|=|0.0016|TWO_SIDED|95.0|15.05|64.29||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline POA as a covariate.|MMRM|||POA: Placebo, Lemborexant 10 mg||64.29|15.05|= 0.0016
71071678|NCT02783729|141651756|SUPERIORITY||LSM Difference|-19.22|STANDARD_ERROR_OF_MEAN|11.779|=|0.1031|TWO_SIDED|95.0|-42.34|3.9||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline POA as a covariate.|MMRM|||POA: Zolpidem ER, Lemborexant 5 mg||3.9|-42.34|= 0.1031
71071679|NCT02783729|141651756|SUPERIORITY||LSM Difference|-10.32|STANDARD_ERROR_OF_MEAN|11.813|=|0.3825|TWO_SIDED|95.0|-33.5|12.86||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline POA as a covariate.|MMRM|||POA: Zolpidem ER, Lemborexant 10 mg||12.86|-33.5|= 0.3825
71071680|NCT02783729|141651756|SUPERIORITY||LSM Difference|28.81|STANDARD_ERROR_OF_MEAN|60.626|=|0.6348|TWO_SIDED|95.0|-90.18|147.8||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline SOMT as a covariate.|MMRM|||SOMT: Placebo, Lemborexant 5 mg||147.8|-90.18|= 0.6348
71071681|NCT02783729|141651756|SUPERIORITY||LSM Difference|50.83|STANDARD_ERROR_OF_MEAN|60.702|=|0.4026|TWO_SIDED|95.0|-68.3|169.97||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline SOMT as a covariate.|MMRM|||SOMT: Placebo, Lemborexant 10 mg||169.97|-68.3|= 0.4026
71071682|NCT02783729|141651756|SUPERIORITY||LSM Difference|-203.36|STANDARD_ERROR_OF_MEAN|57.171|=|0.0004|TWO_SIDED|95.0|-315.56|-91.15||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline SOMT as a covariate.|MMRM|||SOMT: Zolpidem ER, Lemborexant 5 mg||-91.15|-315.56|= 0.0004
71071683|NCT02783729|141651756|SUPERIORITY||LSM Difference|-181.33|STANDARD_ERROR_OF_MEAN|57.255|=|0.0016|TWO_SIDED|95.0|-293.71|-68.96||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline SOMT as a covariate.|MMRM|||SOMT: Zolpidem ER, Lemborexant 10 mg||-68.96|-293.71|= 0.0016
71071684|NCT02783729|141651757|SUPERIORITY||LSM Difference|-0.03|STANDARD_ERROR_OF_MEAN|4.141|=|0.9936|TWO_SIDED|95.0|-8.16|8.09||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline QOM as a covariate.|MMRM|||QOM: Placebo, Lemborexant 5 mg||8.09|-8.16|= 0.9936
71071685|NCT02783729|141651757|SUPERIORITY||LSM Difference|-5.85|STANDARD_ERROR_OF_MEAN|4.154|=|0.1595|TWO_SIDED|95.0|-14.0|2.3||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline QOM as a covariate.|MMRM|||QOM: Placebo, Lemborexant 10 mg||2.3|-14|= 0.1595
71071686|NCT02783729|141651757|SUPERIORITY||LSM Difference|12.73|STANDARD_ERROR_OF_MEAN|3.894|=|0.0011|TWO_SIDED|95.0|5.09|20.38||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline QOM as a covariate.|MMRM|||QOM: Zolpidem ER, Lemborexant 5 mg||20.38|5.09|= 0.0011
71071687|NCT02783729|141651757|SUPERIORITY||LSM Difference|6.92|STANDARD_ERROR_OF_MEAN|3.913|=|0.0774|TWO_SIDED|95.0|-0.76|14.6||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline QOM as a covariate.|MMRM|||QOM: Zolpidem ER, Lemborexant 10 mg||14.6|-0.76|= 0.0774
71071688|NCT02783729|141651757|SUPERIORITY||LSM Difference|0.35|STANDARD_ERROR_OF_MEAN|0.393|=|0.3726|TWO_SIDED|95.0|-0.42|1.12||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline COA as a covariate.|MMRM|||COA: Placebo, Lemborexant 5 mg||1.12|-0.42|= 0.3726
71071689|NCT02783729|141651757|SUPERIORITY||LSM Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.394|=|0.2579|TWO_SIDED|95.0|-1.22|0.33||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline COA as a covariate.|MMRM|||COA: Placebo, Lemborexant 10 mg||0.33|-1.22|= 0.2579
71071690|NCT02783729|141651757|SUPERIORITY||LSM Difference|1.39|STANDARD_ERROR_OF_MEAN|0.37|=|0.0002|TWO_SIDED|95.0|0.66|2.11||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline COA as a covariate.|MMRM|||COA: Zolpidem ER, Lemborexant 5 mg||2.11|0.66|= 0.0002
71071691|NCT02783729|141651757|SUPERIORITY||LSM Difference|0.59|STANDARD_ERROR_OF_MEAN|0.372|=|0.112|TWO_SIDED|95.0|-0.14|1.32||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline COA as a covariate.|MMRM|||COA: Zolpidem ER, Lemborexant 10 mg||1.32|-0.14|= 0.112
71071692|NCT05127304|141651762|OTHER|||||||0.639|||||||Weighted clustered linear regression|||Ambulatory visits||||0.639
71071693|NCT05127304|141651762|OTHER|||||||0.535|||||||Weighted clustered linear regression|||Office visits||||0.535
71071694|NCT05127304|141651762|OTHER|||||||0.337|||||||Weighted clustered linear regression|||Outpatient visits||||0.337
71071695|NCT05127304|141651762|OTHER|||||||0.058|||||||Weighted clustered linear regression|||Emergency room visits||||0.058
71071696|NCT05127304|141651762|OTHER|||||||0.192|||||||Weighted clustered linear regression|||Inpatient visits||||0.192
71071697|NCT05127304|141651762|OTHER|||||||0.176|||||||Weighted clustered linear regression|||Other medical visits||||0.176
71071698|NCT05127304|141651763|OTHER|||||||0.313|||||||Weighted clustered linear regression|||||||0.313
71071699|NCT05127304|141651764|OTHER|||||||0.021|||||||Weighted clustered linear regression|||||||0.021
71071700|NCT05127304|141651765|OTHER|||||||0.022|||||||Weighted clustered linear regression|||Ambulatory visits||||0.022
71071701|NCT05127304|141651765|OTHER|||||||0.124|||||||Weighted clustered linear regression|||Office visits||||0.124
71071702|NCT05127304|141651765|OTHER|||||||0.043|||||||Weighted clustered linear regression|||Outpatient visits||||0.043
71071703|NCT05127304|141651765|OTHER|||||||0.99|||||||Weighted clustered linear regression|||Emergency room visits||||0.990
71071704|NCT05127304|141651765|OTHER|||||||0.039|||||||Weighted clustered linear regression|||Inpatient visits||||0.039
71071705|NCT05127304|141651765|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Other medical visits||||<0.001
71071706|NCT05127304|141651766|OTHER|||||||0.163|||||||Weighted clustered linear regression|||||||0.163
71071707|NCT05127304|141651767|OTHER|||||||0.037|||||||Weighted clustered linear regression|||||||0.037
71071708|NCT05127304|141651768|OTHER|||||||0.017|||||||Weighted clustered linear regression|||Ambulatory visits||||0.017
71071709|NCT05127304|141651768|OTHER|||||||0.098|||||||Weighted clustered linear regression|||Office visits||||0.098
70852949|NCT00797966|141194658|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.35||||0.3441|TWO_SIDED|95.0|0.74|2.44||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||2.44|0.74|0.3441
71071710|NCT05127304|141651768|OTHER|||||||0.036|||||||Weighted clustered linear regression|||Outpatient visits||||0.036
71071711|NCT05127304|141651768|OTHER|||||||0.894|||||||Weighted clustered linear regression|||Emergency room visits||||0.894
71071712|NCT05127304|141651768|OTHER|||||||0.036|||||||Weighted clustered linear regression|||Inpatient visits||||0.036
71071713|NCT05127304|141651768|OTHER|||||||0.001|||||||Weighted clustered linear regression|||Other medical visits||||0.001
71071714|NCT05127304|141651769|OTHER|||||||0.162|||||||Weighted clustered linear regression|||||||0.162
71071715|NCT05127304|141651770|OTHER|||||||0.037|||||||Weighted clustered linear regression|||||||0.037
71071716|NCT05127304|141651771|OTHER|||||||0.065|||||||Weighted clustered linear regression|||Ambulatory visits||||0.065
71071717|NCT05127304|141651771|OTHER|||||||0.102|||||||Weighted clustered linear regression|||Office visits||||0.102
71071718|NCT05127304|141651771|OTHER|||||||0.1|||||||Weighted clustered linear regression|||Outpatient visits||||0.100
71071719|NCT05127304|141651771|OTHER|||||||0.189|||||||Weighted clustered linear regression|||Emergency room visits||||0.189
71071720|NCT05127304|141651771|OTHER|||||||0.024|||||||Weighted clustered linear regression|||Inpatient visits||||0.024
71071721|NCT05127304|141651771|OTHER|||||||0.767|||||||Weighted clustered linear regression|||Other medical visits||||0.767
71071722|NCT05127304|141651772|OTHER|||||||0.357|||||||Weighted clustered linear regression|||||||0.357
71071723|NCT05127304|141651773|OTHER|||||||0.002|||||||Weighted clustered linear regression|||Ambulatory visits||||0.002
71071724|NCT05127304|141651773|OTHER|||||||0.42|||||||Weighted clustered linear regression|||Office visits||||0.420
71071725|NCT05127304|141651773|OTHER|||||||0.002|||||||Weighted clustered linear regression|||Outpatient visits||||0.002
71071726|NCT05127304|141651773|OTHER|||||||0.304|||||||Weighted clustered linear regression|||Emergency room visits||||0.304
71071727|NCT05127304|141651773|OTHER|||||||0.326|||||||Weighted clustered linear regression|||Inpatient visits||||0.326
71071728|NCT05127304|141651773|OTHER|||||||0.007|||||||Weighted clustered linear regression|||Other medical visits||||0.007
71071729|NCT05127304|141651774|OTHER|||||||0.52|||||||Weighted clustered linear regression|||||||0.520
71071730|NCT05127304|141651775|OTHER|||||||0.037|||||||Weighted clustered linear regression|||||||0.037
70939583|NCT02168855|141379852|SUPERIORITY||Odds Ratio (OR)|1.39||||0.46|TWO_SIDED|95.0|0.58|3.29|||Regression, Logistic|This is a logistic regression model of the active versus placebo arm, while controlling for age and cigarettes smoked per day at enrollment.|The active arm is the numerator and the placebo arm is the denominator of the odds ratio|||3.29|0.58|0.46
71114479|NCT04925076|141737193|SUPERIORITY|||||||0.39|||||||ANOVA|F(1,93)=0.76||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the condition X family history interaction.||||.39
70852950|NCT00797966|141194658|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.14||||0.6375|TWO_SIDED|95.0|0.67|1.94||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||1.94|0.67|0.6375
70852951|NCT00797966|141194658|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.31||||0.3135|TWO_SIDED|95.0|0.78|2.21||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||2.21|0.78|0.3135
70852952|NCT00797966|141194658|SUPERIORITY_OR_OTHER||Ratio of Response Rate|2.35||||0.0035|TWO_SIDED|95.0|1.32|4.18||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||4.18|1.32|0.0035
70852953|NCT00797966|141194658|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.27||||0.4358|TWO_SIDED|95.0|0.7|2.31||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||2.31|0.70|0.4358
70852954|NCT00797966|141194658|SUPERIORITY_OR_OTHER||Ratio of Response Rate|2.02||||0.0063|TWO_SIDED|95.0|1.2|3.41||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||3.41|1.20|0.0063
70852955|NCT00797966|141194658|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.27||||0.3968|TWO_SIDED|95.0|0.72|2.23||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||2.23|0.72|0.3968
70852956|NCT00797966|141194658|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.27||||0.299|TWO_SIDED|95.0|0.81|2.0||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||2.00|0.81|0.2990
70852957|NCT00797966|141194658|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.39||||0.1614|TWO_SIDED|95.0|0.86|2.25||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||2.25|0.86|0.1614
70852958|NCT00797966|141194658|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.29||||0.3254|TWO_SIDED|95.0|0.79|2.12||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||2.12|0.79|0.3254
70852959|NCT00797966|141194658|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.02||||0.9463|TWO_SIDED|95.0|0.64|1.62||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||1.62|0.64|0.9463
70852960|NCT00797966|141194658|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.74||||0.008|TWO_SIDED|95.0|1.14|2.65||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||2.65|1.14|0.0080
70852961|NCT00797966|141194659|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.59||||0.5791|TWO_SIDED|95.0|0.09|3.9||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||3.90|0.09|0.5791
70852962|NCT00797966|141194659|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.43||||0.2653|TWO_SIDED|95.0|0.1|1.93||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.93|0.10|0.2653
70852963|NCT00797966|141194659|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.39||||0.2259|TWO_SIDED|95.0|0.08|1.87||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.87|0.08|0.2259
70852964|NCT00797966|141194659|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.83||||0.6986|TWO_SIDED|95.0|0.32|2.18||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||2.18|0.32|0.6986
70852965|NCT00797966|141194659|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.61||||0.2339|TWO_SIDED|95.0|0.28|1.35||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||1.35|0.28|0.2339
70939584|NCT02168855|141379853|SUPERIORITY||Odds Ratio (OR)|1.9|||<|0.0001|TWO_SIDED|95.0|1.83|1.98|||Mixed Models Analysis|Includes random subject intercept effect|Reflects an odds ratio relative to a 10-unit increase in craving. Temptations are the numerator and background is the denominator.|||1.98|1.83|<0.0001
70939585|NCT02168855|141379854|SUPERIORITY||Odds Ratio (OR)|1.66|||<|0.0001|TWO_SIDED|95.0|1.51|1.83|||Mixed Models Analysis|Includes random subject intercept effect|Reflects an odds ratio relative to a 10-unit increase in negative affect T-score. Temptations are the numerator and background is the denominator.|||1.83|1.51|<0.0001
70852966|NCT00797966|141194659|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.07||||0.8615|TWO_SIDED|95.0|0.53|2.15||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||2.15|0.53|0.8615
70852967|NCT00797966|141194659|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.06||||0.8807|TWO_SIDED|95.0|0.51|2.2||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||2.20|0.51|0.8807
70852968|NCT00797966|141194659|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.96||||0.9035|TWO_SIDED|95.0|0.52|1.77||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||1.77|0.52|0.9035
70852969|NCT00797966|141194659|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.19||||0.5898|TWO_SIDED|95.0|0.64|2.24|||Cochran-Mantel-Haenszel|||Week 11 values presented here.||2.24|0.64|0.5898
70852970|NCT00797966|141194659|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.82||||0.084|TWO_SIDED|95.0|0.93|3.58||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||3.58|0.93|0.0840
70852971|NCT00797966|141194659|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.96||||0.9115|TWO_SIDED|95.0|0.49|1.88||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||1.88|0.49|0.9115
70939586|NCT02168855|141379855|SUPERIORITY||Odds Ratio (OR)|0.18|||<|0.0001|TWO_SIDED|95.0|0.14|0.21|||Regression, Logistic|Includes random subject intercept effect|Odds ratio where temptations are the numerator and background is the denominator, that no smoking cues were seen.|||0.21|0.14|<0.0001
70939587|NCT02168855|141379856|SUPERIORITY||Odds Ratio (OR)|0.19|||<|0.0001|TWO_SIDED|95.0|0.15|0.23|||Regression, Logistic||Odds ratio where temptations are the numerator and background is the denominator, that no other people were seen smoking nearby.|||0.23|0.15|<0.0001
70939588|NCT03000829|141379892|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
70939589|NCT03000829|141379893|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|||||||0.86
70939590|NCT03000829|141379894|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
70939591|NCT03000829|141379895|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||||||0.87
70939592|NCT03000829|141379896|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||||||0.63
71071731|NCT05127304|141651776|OTHER|||||||0.06|||||||Weighted clustered linear regression|||Medical costs||||0.060
70939593|NCT03000829|141379897|SUPERIORITY|||||||0.62|||||||t-test, 2 sided|||||||0.62
70939594|NCT03000829|141379898|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
70939595|NCT03000829|141379899|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||0.40
70939596|NCT03000829|141379902|SUPERIORITY|||||||0.92|||||||Mixed Models Analysis|||||||0.92
70939597|NCT03451292|141379959|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.17|TWO_SIDED|95.0|0.58|1.1|||Cox Proportional- Hazards (PH) model|||Stratification factors included were the region (Europe or North America) and history of hospitalization for acute decompensation of liver cirrhosis (yes or no).||1.10|0.58|0.17
70939598|NCT05030467|141379967|SUPERIORITY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.39|0.31||||||We used generalized estimating equations (GEE) to adjust for the cluster design with an identify link function and normally-distributed errors||0.31|-0.39|
70939599|NCT05030467|141379968|SUPERIORITY||Risk Ratio (RR)|1.02||||0.011|TWO_SIDED|95.0|1.0|1.03|||Regression, Logistic|||Outcomes were evaluated using generalized estimating equations with a log link and Poisson-distributed errors, adjusting for clinic-level clustering.||1.03|1.00|0.011
70939600|NCT05030467|141379971|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.383|TWO_SIDED|95.0|-0.38|0.15|||Regression, Linear|||We used generalized estimating equations (GEE) to adjust for the cluster design with an identify link function and normally-distributed errors||0.15|-0.38|0.383
70939601|NCT03320941|141380018|OTHER|Dose Finding|Mean Difference (Net)|-1.99|||||TWO_SIDED|95.0|-2.92|-0.21||||||||-0.21|-2.92|
71071732|NCT05127304|141651776|OTHER|||||||0.177|||||||Weighted clustered linear regression|||Ambulatory costs||||0.177
71071733|NCT05127304|141651776|OTHER|||||||0.834|||||||Weighted clustered linear regression|||Office visits costs||||0.834
70939602|NCT03320941|141380018|OTHER|Dose Finding|Mean Difference (Net)|-3.0|||||TWO_SIDED|95.0|-4.15|-1.7||||||||-1.70|-4.15|
70939603|NCT03320941|141380018|OTHER|Dose Finding|Mean Difference (Net)|-3.54|||||TWO_SIDED|95.0|-4.54|-2.26||||||||-2.26|-4.54|
70939604|NCT03320941|141380018|OTHER|Dose Finding|Mean Difference (Net)|-3.91|||||TWO_SIDED|95.0|-5.01|-2.77||||||||-2.77|-5.01|
70939605|NCT03320941|141380019|OTHER|Dose Finding|Odds Ratio (OR)|2.299||||0.39|TWO_SIDED|95.0|0.344|15.35|||Regression, Logistic|||\>= 3% Percent decrease in body weight||15.350|0.344|0.390
70939606|NCT03320941|141380019|OTHER|Dose Finding|Odds Ratio (OR)|15.78||||0.002|TWO_SIDED|95.0|2.844|87.552|||Regression, Logistic|||\>= 3% Percent decrease in body weight||87.552|2.844|0.002
70939607|NCT03320941|141380019|OTHER|Dose Finding|Odds Ratio (OR)|12.708||||0.002|TWO_SIDED|95.0|2.511|64.32|||Regression, Logistic|||\>= 3% Percent decrease in body weight||64.320|2.511|0.002
70939608|NCT03320941|141380019|OTHER|Dose Finding|Odds Ratio (OR)|16.813|||<|0.001|TWO_SIDED|95.0|3.362|84.085|||Regression, Logistic|||\>= 3% Percent decrease in body weight||84.085|3.362|<0.001
70939609|NCT03320941|141380019|OTHER|Dose Finding|Odds Ratio (OR)|1.697||||0.727|TWO_SIDED|95.0|0.087|33.006|||Regression, Logistic|||\>= 3% Percent decrease in body weight (Dysglycemic)||33.006|0.087|0.727
70939610|NCT03320941|141380019|OTHER|Dose Finding|Odds Ratio (OR)|28.26||||0.012|TWO_SIDED|95.0|2.066|386.473|||Regression, Logistic|||\>= 3% Percent decrease in body weight (Dysglycemic)||386.473|2.066|0.012
70939611|NCT03320941|141380019|OTHER|Dose Finding|Odds Ratio (OR)|10.333||||0.059|TWO_SIDED|95.0|0.914|116.82|||Regression, Logistic|||\>= 3% Percent decrease in body weight (Dysglycemic)||116.820|0.914|0.059
70939612|NCT03320941|141380019|OTHER|Dose Finding|Odds Ratio (OR)|9.456||||0.062|TWO_SIDED|95.0|0.891|100.292|||Regression, Logistic|||\>= 3% Percent decrease in body weight (Dysglycemic)||100.292|0.891|0.062
70939613|NCT03320941|141380019|OTHER|Dose Finding|Odds Ratio (OR)|3.59||||0.336|TWO_SIDED|95.0|0.265|48.552|||Regression, Logistic|||\>= 3% Percent decrease in body weight (T2DM)||48.552|0.265|0.336
70939614|NCT03320941|141380019|OTHER|Dose Finding|Odds Ratio, log|9.112||||0.075|TWO_SIDED|95.0|0.799|103.872|||Regression, Logistic|||\>= 3% Percent decrease in body weight (T2DM)||103.872|0.799|0.075
70939615|NCT03320941|141380019|OTHER|Dose Finding|Odds Ratio (OR)|29.312||||0.006|TWO_SIDED|95.0|2.665|322.412|||Regression, Logistic|||\>= 3% Percent decrease in body weight (T2DM)||322.412|2.665|0.006
70939616|NCT03320941|141380019|OTHER|Dose Finding|Odds Ratio (OR)|37.949||||0.003|TWO_SIDED|95.0|3.477|414.232|||Regression, Logistic|||\>= 3% Percent decrease in body weight (T2DM)||414.232|3.477|0.003
70939617|NCT03320941|141380020|OTHER|Dose Finding|Median Difference (Final Values)|-1.84|||||TWO_SIDED|95.0|-3.56|-0.19||||||Dysglycemic||-0.19|-3.56|
70939618|NCT03320941|141380020|OTHER|Dose Finding|Mean Difference (Final Values)|-2.98|||||TWO_SIDED|95.0|-4.56|-1.46||||||Dysglycemic||-1.46|-4.56|
71071734|NCT05127304|141651776|OTHER|||||||0.121|||||||Weighted clustered linear regression|||Outpatient visits costs||||0.121
71071735|NCT05127304|141651776|OTHER|||||||0.159|||||||Weighted clustered linear regression|||Emergency room visits costs||||0.159
71071736|NCT05127304|141651776|OTHER|||||||0.289|||||||Weighted clustered linear regression|||Inpatient stay costs||||0.289
71071737|NCT05127304|141651776|OTHER|||||||0.055|||||||Weighted clustered linear regression|||Other medical costs||||0.055
71071738|NCT05127304|141651776|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Pharmacy costs||||<0.001
71071739|NCT05127304|141651776|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Total (medical + pharmacy) costs||||<0.001
71071740|NCT05127304|141651777|OTHER|||||||0.066|||||||Weighted clustered linear regression|||Medical costs||||0.066
71071741|NCT05127304|141651777|OTHER|||||||0.193|||||||Weighted clustered linear regression|||Ambulatory costs||||0.193
70939619|NCT03320941|141380020|OTHER|Dose Finding|Mean Difference (Final Values)|-3.33|||||TWO_SIDED|95.0|-4.71|-1.82||||||Dysglycemic||-1.82|-4.71|
71114480|NCT04925076|141737193|SUPERIORITY|||||||0.89|||||||ANOVA|F(1,93)=0.02||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the family history X sex interaction.||||.89
70939620|NCT03320941|141380020|OTHER|Dose Finding|Mean Difference (Final Values)|-3.51|||||TWO_SIDED|95.0|-4.93|-1.74||||||Dysglycemic||-1.74|-4.93|
70939621|NCT03320941|141380020|OTHER|Dose Finding|Mean Difference (Final Values)|-1.96|||||TWO_SIDED|95.0|-3.12|-0.15||||||T2DM||-0.15|-3.12|
70939622|NCT03320941|141380020|OTHER|Dose Finding|Mean Difference (Final Values)|-2.88|||||TWO_SIDED|95.0|-4.37|-0.61||||||T2DM||-0.61|-4.37|
70939623|NCT03320941|141380020|OTHER|Dose Finding|Mean Difference (Final Values)|-3.64|||||TWO_SIDED|95.0|-5.2|-1.52||||||T2DM||-1.52|-5.20|
70939624|NCT03320941|141380020|OTHER|Dose Finding|Median Difference (Final Values)|-4.37|||||TWO_SIDED|95.0|-5.93|-2.79||||||T2DM||-2.79|-5.93|
70939625|NCT03320941|141380021|OTHER|Dose Finding|Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|1.011||0.278|TWO_SIDED|95.0|-3.104|0.9|||ANCOVA|||Overall Study||0.900|-3.104|0.278
70939626|NCT03320941|141380021|OTHER|Dose Finding|Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|1.013||0.216|TWO_SIDED|95.0|-3.265|0.747|||ANCOVA|||Overall Study||0.747|-3.265|0.216
70939627|NCT03320941|141380021|OTHER|Dose Finding|Mean Difference (Final Values)|-1.28|STANDARD_ERROR_OF_MEAN|0.902||0.158|TWO_SIDED|95.0|-3.069|0.504|||ANCOVA|||Overall Study||0.504|-3.069|0.158
70939628|NCT03320941|141380021|OTHER|Dose Finding|Mean Difference (Final Values)|-1.74|STANDARD_ERROR_OF_MEAN|0.89||0.053|TWO_SIDED|95.0|-3.401|0.022|||ANCOVA|||Overall Study||0.022|-3.401|0.053
70939629|NCT03320941|141380021|OTHER|Dose Finding|Mean Difference (Final Values)|-2.36|STANDARD_ERROR_OF_MEAN|1.534||0.13|TWO_SIDED|95.0|-5.444|0.717|||ANCOVA|||Dysglycemic||0.717|-5.444|0.130
70939630|NCT03320941|141380021|OTHER|Dose Finding|Mean Difference (Final Values)|-4.08|STANDARD_ERROR_OF_MEAN|1.534||0.011|TWO_SIDED|95.0|-7.156|-0.994|||ANCOVA|||Dysglycemic||-0.994|-7.156|0.011
70939631|NCT03320941|141380021|OTHER|Dose Finding|Mean Difference (Final Values)|-1.66|STANDARD_ERROR_OF_MEAN|1.325||0.215|TWO_SIDED|95.0|-4.322|0.996|||ANCOVA|||Dysglycemic||0.996|-4.322|0.215
70939632|NCT03320941|141380021|OTHER|Dose Finding|Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|1.346||0.184|TWO_SIDED|95.0|-4.515|0.888|||ANCOVA|||Dysglycemic||0.888|-4.515|0.184
70939633|NCT03320941|141380021|OTHER|Dose Finding|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|1.292||0.982|TWO_SIDED|95.0|-2.611|2.552|||ANCOVA|||T2DM||2.552|-2.611|0.982
71071742|NCT05127304|141651777|OTHER|||||||0.117|||||||Weighted clustered linear regression|||Office visits costs||||0.117
71071743|NCT05127304|141651777|OTHER|||||||0.25|||||||Weighted clustered linear regression|||Outpatient visits costs||||0.250
71071744|NCT05127304|141651777|OTHER|||||||0.431|||||||Weighted clustered linear regression|||Emergency room visits costs||||0.431
71071745|NCT05127304|141651777|OTHER|||||||0.129|||||||Weighted clustered linear regression|||Inpatient stay costs||||0.129
71071746|NCT05127304|141651777|OTHER|||||||0.236|||||||Weighted clustered linear regression|||Other medical costs||||0.236
71071747|NCT05127304|141651777|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Pharmacy costs||||<0.001
71071748|NCT05127304|141651777|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Total (medical + pharmacy) costs||||<0.001
70939634|NCT03320941|141380021|OTHER|Dose Finding|Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|1.304||0.544|TWO_SIDED|95.0|-1.809|3.401|||ANCOVA|||T2DM||3.401|-1.809|0.544
70939635|NCT03320941|141380021|OTHER|Dose Finding|Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|1.188||0.552|TWO_SIDED|95.0|-3.084|1.663|||ANCOVA|||T2DM||1.663|-3.084|0.552
70939636|NCT03320941|141380021|OTHER|Dose Finding|Mean Difference (Final Values)|-1.69|STANDARD_ERROR_OF_MEAN|1.139||0.143|TWO_SIDED|95.0|-3.964|0.588|||ANCOVA|||T2DM||0.588|-3.964|0.143
70939637|NCT03320941|141380022|OTHER|Dose Finding|Mean Difference (Final Values)|-0.206|STANDARD_ERROR_OF_MEAN|0.086||0.018|TWO_SIDED|95.0|-0.376|-0.035|||ANCOVA|||Overall Study||-0.035|-0.376|0.018
70939638|NCT03320941|141380022|OTHER|Dose Finding|Mean Difference (Final Values)|-0.276|STANDARD_ERROR_OF_MEAN|0.0863||0.002|TWO_SIDED|95.0|-0.447|-0.105|||ANCOVA|||Overall Study||-0.105|-0.447|0.002
70939639|NCT03320941|141380022|OTHER|Dose Finding|Mean Difference (Final Values)|-0.287|STANDARD_ERROR_OF_MEAN|0.076|<|0.001|TWO_SIDED|95.0|-0.437|-0.136|||ANCOVA|||Overall Study||-0.136|-0.437|<0.001
70939640|NCT03320941|141380022|OTHER|Dose Finding|Mean Difference (Final Values)|-0.338|STANDARD_ERROR_OF_MEAN|0.0747|<|0.001|TWO_SIDED|95.0|-0.486|-0.19|||ANCOVA|||Overall Study||-0.190|-0.486|<0.001
70939641|NCT03320941|141380022|OTHER|Dose Finding|Mean Difference (Final Values)|-0.089|STANDARD_ERROR_OF_MEAN|0.0775||0.258|TWO_SIDED|95.0|-0.245|0.067|||ANCOVA|||Dysglycemic||0.067|-0.245|0.258
70939642|NCT03320941|141380022|OTHER|Dose Finding|Mean Difference (Final Values)|-0.134|STANDARD_ERROR_OF_MEAN|0.0774||0.088|TWO_SIDED|95.0|-0.29|0.021|||ANCOVA|||Dysglycemic||0.021|-0.290|0.088
71071749|NCT05127304|141651778|OTHER|||||||0.057|||||||Weighted clustered linear regression|||Medical costs||||0.057
71071750|NCT05127304|141651778|OTHER|||||||0.182|||||||Weighted clustered linear regression|||Ambulatory costs||||0.182
71071751|NCT05127304|141651778|OTHER|||||||0.083|||||||Weighted clustered linear regression|||Office visits costs||||0.083
71071752|NCT05127304|141651778|OTHER|||||||0.245|||||||Weighted clustered linear regression|||Outpatient visits costs||||0.245
71071753|NCT05127304|141651778|OTHER|||||||0.386|||||||Weighted clustered linear regression|||Emergency room visits costs||||0.386
71071754|NCT05127304|141651778|OTHER|||||||0.115|||||||Weighted clustered linear regression|||Inpatient stay costs||||0.115
71071755|NCT05127304|141651778|OTHER|||||||0.237|||||||Weighted clustered linear regression|||Other medical costs||||0.237
71071756|NCT05127304|141651778|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Pharmacy costs||||<0.001
71071757|NCT05127304|141651778|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Total (medical + pharmacy) costs||||<0.001
71071758|NCT05127304|141651779|OTHER|||||||0.189|||||||Weighted clustered linear regression|||Medical costs||||0.189
71071759|NCT05127304|141651779|OTHER|||||||0.314|||||||Weighted clustered linear regression|||Ambulatory costs||||0.314
71071760|NCT05127304|141651779|OTHER|||||||0.203|||||||Weighted clustered linear regression|||Office visits costs||||0.203
70939643|NCT03320941|141380022|OTHER|Dose Finding|Mean Difference (Final Values)|-0.146|STANDARD_ERROR_OF_MEAN|0.0673||0.035|TWO_SIDED|95.0|-0.282|-0.011|||ANCOVA|||Dysglycemic||-0.011|-0.282|0.035
70852972|NCT00797966|141194659|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.77||||0.0522|TWO_SIDED|95.0|0.98|3.17||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||3.17|0.98|0.0522
70852973|NCT00797966|141194659|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.24||||0.4997|TWO_SIDED|95.0|0.65|2.34||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||2.34|0.65|0.4997
70939644|NCT03320941|141380022|OTHER|Dose Finding|Mean Difference (Final Values)|-0.113|STANDARD_ERROR_OF_MEAN|0.0673||0.1|TWO_SIDED|95.0|-0.248|0.022|||ANCOVA|||Dysglycemic||0.022|-0.248|0.100
70939645|NCT03320941|141380022|OTHER|Dose Finding|Mean Difference (Final Values)|-0.313|STANDARD_ERROR_OF_MEAN|0.1399||0.029|TWO_SIDED|95.0|-0.592|-0.033|||ANCOVA|||T2DM||-0.033|-0.592|0.029
70939646|NCT03320941|141380022|OTHER|Dose Finding|Mean Difference (Final Values)|-0.399|STANDARD_ERROR_OF_MEAN|0.1411||0.006|TWO_SIDED|95.0|-0.681|-0.117|||ANCOVA|||T2DM||-0.117|-0.681|0.006
70939647|NCT03320941|141380022|OTHER|Dose Finding|Mean Difference (Final Values)|-0.409|STANDARD_ERROR_OF_MEAN|0.1253||0.002|TWO_SIDED|95.0|-0.66|-0.159|||ANCOVA|||T2DM||-0.159|-0.660|0.002
70939648|NCT03320941|141380022|OTHER|Dose Finding|Mean Difference (Final Values)|-0.526|STANDARD_ERROR_OF_MEAN|0.1217|<|0.001|TWO_SIDED|95.0|-0.769|-0.282|||ANCOVA|||T2DM||-0.282|-0.769|<0.001
71071761|NCT05127304|141651779|OTHER|||||||0.379|||||||Weighted clustered linear regression|||Outpatient visits costs||||0.379
71071762|NCT05127304|141651779|OTHER|||||||0.815|||||||Weighted clustered linear regression|||Emergency room visits costs||||0.815
71071763|NCT05127304|141651779|OTHER|||||||0.205|||||||Weighted clustered linear regression|||Inpatient stay costs||||0.205
71071764|NCT05127304|141651779|OTHER|||||||0.556|||||||Weighted clustered linear regression|||Other medical costs||||0.556
71071765|NCT05127304|141651779|OTHER|||||||0.189|||||||Weighted clustered linear regression|||Total (medical + pharmacy) costs||||0.189
71071766|NCT05127304|141651780|OTHER|||||||0.483|||||||Weighted clustered linear regression|||Medical costs||||0.483
71071767|NCT05127304|141651780|OTHER|||||||0.002|||||||Weighted clustered linear regression|||Ambulatory costs||||0.002
71071768|NCT05127304|141651780|OTHER|||||||0.123|||||||Weighted clustered linear regression|||Office visits costs||||0.123
71071769|NCT05127304|141651780|OTHER|||||||0.003|||||||Weighted clustered linear regression|||Outpatient visits costs||||0.003
71071770|NCT05127304|141651780|OTHER|||||||0.17|||||||Weighted clustered linear regression|||Emergency room visits costs||||0.170
71071771|NCT05127304|141651780|OTHER|||||||0.582|||||||Weighted clustered linear regression|||Inpatient stay costs||||0.582
71071772|NCT05127304|141651780|OTHER|||||||0.887|||||||Weighted clustered linear regression|||Other medical costs||||0.887
71071773|NCT05127304|141651780|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Pharmacy costs||||<0.001
71071774|NCT05127304|141651780|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Total (medical + pharmacy) costs||||<0.001
71071775|NCT05127304|141651781|OTHER|||||||0.205|||||||Weighted clustered linear regression|||Any COPD exacerbation||||0.205
71071776|NCT05127304|141651781|OTHER|||||||0.454|||||||Weighted clustered linear regression|||Severe COPD exacerbation||||0.454
71071777|NCT05127304|141651782|OTHER|||||||0.06|||||||Rao-Scott test|||||||0.060
71071778|NCT01323010|141651896|SUPERIORITY_OR_OTHER|||||||0.689|TWO_SIDED||||||Chi-squared|||||||0.689
71071779|NCT01323010|141651897|SUPERIORITY_OR_OTHER|||||||0.591|TWO_SIDED||||||t-test, 2 sided|||||||0.591
71071780|NCT01323010|141651898|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||ANOVA|Method: ANOVA with repetead measures for non parametric data proposed by Brunner and Piri.||||||0.150
71071781|NCT01323010|141651899|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.042
71071782|NCT01323010|141651900|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED||||||ANOVA|||||||0.108
71071783|NCT01323010|141651902|SUPERIORITY_OR_OTHER|||||||0.122|TWO_SIDED||||||ANOVA|||||||0.122
71071784|NCT01323010|141651904|SUPERIORITY_OR_OTHER|||||||0.164|TWO_SIDED||||||ANOVA|Method: ANOVA with repetead measures for non paramteric data proposed by Brunner and Piri.||||||0.164
71071785|NCT01323010|141651905|SUPERIORITY_OR_OTHER|||||||0.165|TWO_SIDED||||||ANOVA|||||||0.165
71071786|NCT01323010|141651906|SUPERIORITY_OR_OTHER|||||||0.436|TWO_SIDED||||||ANOVA|||||||0.436
71071787|NCT01323010|141651907|SUPERIORITY_OR_OTHER|||||||0.046|TWO_SIDED||||||ANOVA|||||||0.046
71071788|NCT01323010|141651908|SUPERIORITY_OR_OTHER|||||||0.723|TWO_SIDED||||||ANOVA|||||||0.723
71071789|NCT01323010|141651909|SUPERIORITY_OR_OTHER|||||||0.235|TWO_SIDED||||||ANOVA|||||||0.235
71071790|NCT01323010|141651910|SUPERIORITY_OR_OTHER|||||||0.284|TWO_SIDED||||||ANOVA|||||||0.284
71071791|NCT01323010|141651911|SUPERIORITY_OR_OTHER|||||||0.905|TWO_SIDED||||||ANOVA|||||||0.905
71071792|NCT01323010|141651914|SUPERIORITY_OR_OTHER|||||||0.892|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.892
71071793|NCT01323010|141651915|SUPERIORITY_OR_OTHER|||||||0.195|TWO_SIDED||||||Chi-squared|||||||0.195
71071794|NCT01323010|141651916|SUPERIORITY_OR_OTHER|||||||0.203|TWO_SIDED||||||Chi-squared, Corrected|||||||0.203
71071795|NCT01323010|141651917|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Chi-squared|||||||0.03
71071796|NCT01056198|141651962|SUPERIORITY_OR_OTHER||||||=|0.208||95.0|||||ANCOVA|||The BWAT-m scores were compared at each of the 4 treatment weeks and at the end of the follow-up using a mixed-effects ANCOVA for the intent-to-treat population. Treatment and treatment week, as well as their interaction, were defined as fixed effects with subject as a random effect. The BWAT-m score at baseline was used as a covariate.||||=0.208
71071797|NCT01056198|141651963|SUPERIORITY_OR_OTHER||||||=|0.2737||95.0|||||ANCOVA|||Null hypothesis: no differences between the 2 treatments with the alternative of non-zero differences. 48 evaluable subjects is sufficient to detect an effect size of 0.80.||||=0.2737
71071798|NCT01056198|141651964|SUPERIORITY_OR_OTHER||||||=|0.2741||95.0|||||ANCOVA|||Null hypothesis: no differences between the 2 treatments with the alternative of non-zero differences. 48 evaluable subjects is sufficient to detect an effect size of 0.80.||||=0.2741
71071799|NCT01056198|141651965|SUPERIORITY_OR_OTHER||||||=|0.0164||95.0|||||t-test, 2 sided|||Paired t-test, 2-sided, alpha = 0.05||||=0.0164
71071800|NCT01056198|141651966|SUPERIORITY_OR_OTHER||||||=|0.9392||95.0|||||t-test, 2 sided|||Paired t-test, 2-sided, alpha = 0.05||||=0.9392
71071801|NCT02294175|141651969|SUPERIORITY|||||||0.029||||||Repeated Measures ANOVA. The interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).|Repeated Measures ANOVA|Greenhouse-Geisser corrections were applied to the F test degrees of freedom due to violation of the sphericity assumption (p\<.05 for Mauchly's W).||Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether the reduction of bacterial CFUs over time varies according to treatment arm.||||.029
71071802|NCT02294175|141651970|SUPERIORITY|||||||0.037||||||Repeated Measures ANOVA. This interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).|Repeated Measures ANOVA|Greenhouse-Geisser corrections were applied to the F test degrees of freedom due to violation of the sphericity assumption (p\<.05 for Mauchly's W).||Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether the reduction of bacterial CFUs over time varies according to treatment arm.||||.037
71071803|NCT02294175|141651971|SUPERIORITY|||||||0.012||||||Repeated Measures ANOVA. This interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).|Repeated Measures ANOVA|||Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether the reduction of bacterial CFUs over time varies according to treatment arm.||||.012
71071804|NCT02294175|141651972|SUPERIORITY|||||||0.397|||||||t-test, 2 sided|||||||.397
71071805|NCT02294175|141651973|SUPERIORITY|||||||0.661||||||Repeated Measures ANOVA. The interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).|Repeated Measures ANOVA|||Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether change in MMP-9 over time varies according to treatment arm.||||.661
71071806|NCT02294175|141651974|SUPERIORITY|||||||0.979||||||Repeated Measures ANOVA. The interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).|Repeated Measures ANOVA|||Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether change in IL6 over time varies according to treatment arm.||||.979
71071807|NCT02294175|141651975|SUPERIORITY|||||||0.999|||||||Kolmogorov-Smirnov Z|||Kolmogorov-Smirnov Z test was used as a non-parametric test to compare rank scores between treatment arms (similar to Mann-Whitney, but potentially more powerful).||||.999
71071808|NCT02294175|141651976|SUPERIORITY|||||||0.415|||||||Kolmogorov-Smirnov Z|||Kolmogorov-Smirnov Z test was used as a non-parametric test to compare rank scores between treatment arms (similar to Mann-Whitney, but potentially more powerful).||||.415
71071809|NCT02294175|141651977|SUPERIORITY|||||||0.993|||||||Kolmogorov-Smirnov Z|||Kolmogorov-Smirnov Z test was used as a non-parametric test to compare rank scores between treatment arms (similar to Mann-Whitney, but potentially more powerful).||||.993
70852974|NCT00797966|141194659|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.16||||0.5846|TWO_SIDED|95.0|0.69|1.93||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||1.93|0.69|0.5846
70852975|NCT00797966|141194659|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.99||||0.9602|TWO_SIDED|95.0|0.55|1.76||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||1.76|0.55|0.9602
70852976|NCT00797966|141194659|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.62||||0.1254|TWO_SIDED|95.0|0.87|3.02||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||3.02|0.87|0.1254
70852977|NCT00797966|141194659|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.13||||0.667|TWO_SIDED|95.0|0.65|1.99||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||1.99|0.65|0.6670
70852978|NCT00797966|141194659|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.7||||0.0525|TWO_SIDED|95.0|0.98|2.93||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||2.93|0.98|0.0525
70939649|NCT03320941|141380023|OTHER|Dose Finding|Mean Difference (Final Values)|-0.174|STANDARD_ERROR_OF_MEAN|0.2094||0.408|TWO_SIDED|95.0|-0.589|0.241|||ANCOVA|||Overall Study||0.241|-0.589|0.408
70852979|NCT00797966|141194660|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.98||||0.9462|TWO_SIDED|95.0|0.52|1.84||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.84|0.52|0.9462
70852980|NCT00797966|141194660|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.8||||0.4971|TWO_SIDED|95.0|0.43|1.49||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.49|0.43|0.4971
70852981|NCT00797966|141194660|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.93||||0.8118|TWO_SIDED|95.0|0.53|1.63||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.63|0.53|0.8118
70852982|NCT00797966|141194660|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.95||||0.8323|TWO_SIDED|95.0|0.59|1.53||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||1.53|0.59|0.8323
70852983|NCT00797966|141194660|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.68||||0.093|TWO_SIDED|95.0|0.43|1.08||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||1.08|0.43|0.0930
71071810|NCT02294175|141651978|SUPERIORITY|||||||0.99|||||||Kolmogorov-Smirnov Z|||Kolmogorov-Smirnov Z test was used as a non-parametric test to compare rank scores between treatment arms (similar to Mann-Whitney, but potentially more powerful).||||.990
71071811|NCT00792688|141651979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0062||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0062
71071812|NCT00792688|141651979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0331||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0331
71114481|NCT04925076|141737193|SUPERIORITY|||||||0.01|||||||ANOVA|F(1,93)=6.72||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the main effect of condition.||||.01
71114482|NCT04925076|141737193|SUPERIORITY|||||||0.08|||||||ANOVA|F(1,93)=3.15||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the main effect of family history.||||.08
71114483|NCT04925076|141737193|SUPERIORITY|||||||0.06|||||||ANOVA|F(1,93)=3.71||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the main effect of sex.||||.06
71114484|NCT04925076|141737194|SUPERIORITY|||||||0.29|||||||ANOVA|F(1,93)=1.14||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on periaqueductal gray activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.29
71114485|NCT04925076|141737194|SUPERIORITY|||||||0.1|||||||ANOVA|F(1,93)=2.84||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the condition X sex interaction.||||.10
71114486|NCT04925076|141737194|SUPERIORITY|||||||0.49|||||||ANOVA|F(1,93)=0.47||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on periaqueductal gray activation. Here we report the results of the analysis of the condition X family history interaction.||||.49
71114487|NCT04925076|141737194|SUPERIORITY|||||||0.99|||||||ANOVA|F(1,93)=0.000||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on periaqueductal gray activation. Here we report the results of the analysis of the family history X sex interaction.||||.99
71114488|NCT04925076|141737194|SUPERIORITY|||||||0.13|||||||ANOVA|F(1,93)=2.29||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on periaqueductal gray activation. Here we report the results of the analysis of the main effect of condition.||||.13
71114489|NCT04925076|141737194|SUPERIORITY|||||||0.82|||||||ANOVA|F(1,93)=0.05||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on periaqueductal gray activation. Here we report the results of the analysis of the main effect of family history.||||.82
71114490|NCT04925076|141737194|SUPERIORITY|||||||0.02|||||||ANOVA|F(1,93)=6.09||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on periaqueductal gray activation. Here we report the results of the analysis of the main effect of sex.||||0.02
71114491|NCT04925076|141737195|SUPERIORITY|||||||0.32|||||||ANOVA|F(1,93)=1.01||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.32
71114492|NCT04925076|141737195|SUPERIORITY|||||||0.99|||||||ANOVA|F(1,93)=0.000||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the condition X sex interaction.||||.99
71114493|NCT04925076|141737195|SUPERIORITY|||||||0.83|||||||ANOVA|F(1,93)=0.05||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the condition X family history interaction.||||.83
71114494|NCT04925076|141737195|SUPERIORITY|||||||0.75|||||||ANOVA|F(1,93)=0.10||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the family history X sex interaction.||||.75
71114495|NCT04925076|141737195|SUPERIORITY|||||||0.62|||||||ANOVA|F(1,93)=0.25||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the main effect of condition.||||.62
71114496|NCT04925076|141737195|SUPERIORITY|||||||0.92|||||||ANOVA|F(1,93)=0.01||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the main effect of family history.||||.92
71114497|NCT04925076|141737195|SUPERIORITY|||||||0.39|||||||ANOVA|F(1,93)=0.76||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the main effect of sex.||||.39
71114498|NCT04925076|141737196|SUPERIORITY|||||||0.5|||||||ANOVA|F(1,93)=0.45||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.50
71114499|NCT04925076|141737196|SUPERIORITY|||||||0.28|||||||ANOVA|F(1,93)=1.20||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the condition X sex interaction.||||.28
71114500|NCT04925076|141737196|SUPERIORITY|||||||0.6|||||||ANOVA|F(1,93)=0.28||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the condition X family history interaction.||||.60
71114501|NCT04925076|141737196|SUPERIORITY|||||||0.04|||||||ANOVA|F(1,93)=4.48||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the family history X sex interaction.||||.04
71114502|NCT04925076|141737196|SUPERIORITY|||||||0.25|||||||ANOVA|F(1,93)=1.37||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the main effect of condition.||||.25
71114503|NCT04925076|141737196|SUPERIORITY|||||||0.89|||||||ANOVA|F(1,93)=0.01||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the main effect of family history.||||.89
71114504|NCT04925076|141737196|SUPERIORITY|||||||0.26|||||||ANOVA|F(1,93)=1.28||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the main effect of sex.||||.26
71071813|NCT05238025|141651982|OTHER|Vaccine Efficacy (VE) is defined as 1 minus the hazard ratio resulting from a Cox proportional hazards regression model stratified by age group. It is demonstrated if the lower limit (LL) of the 2-sided 95% confidence interval (CI) for VE is above 20%|Vaccine Efficacy|42.9|||||TWO_SIDED|95.0|-16.1|71.9||||||||71.9|-16.1|
70852984|NCT00797966|141194660|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.88||||0.553|TWO_SIDED|95.0|0.59|1.32||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||1.32|0.59|0.5530
70939650|NCT03320941|141380023|OTHER|Dose Finding|Mean Difference (Final Values)|-0.505|STANDARD_ERROR_OF_MEAN|0.2115||0.018|TWO_SIDED|95.0|-0.924|-0.087|||ANCOVA|||Overall Study||-0.087|-0.924|0.018
70939651|NCT03320941|141380023|OTHER|Dose Finding|Mean Difference (Final Values)|-0.587|STANDARD_ERROR_OF_MEAN|0.1866||0.002|TWO_SIDED|95.0|-0.956|-0.217|||ANCOVA|||Overall Study||-0.217|-0.956|0.002
71071814|NCT05238025|141651983|OTHER|Vaccine Efficacy (VE) is defined as 1 minus the hazard ratio resulting from a Cox proportional hazards regression model stratified by age group. It is demonstrated if the first primary outcome is met and the lower limit (LL) of the 2-sided 95% confidence interval (CI) for VE is above 20%|Vaccine Efficacy|59.0|||||TWO_SIDED|95.0|34.7|74.3|||||Not formally tested, since the first primary outcome was not met|||74.3|34.7|
71071815|NCT05238025|141651984|OTHER|Vaccine Efficacy (VE) is defined as 1 minus the hazard ratio resulting from a Cox proportional hazards regression model stratified by age group. It is demonstrated if both primary outcomes are met and the lower limit (LL) of the 2-sided 95% confidence interval (CI) for VE is above 20%|Vaccine Efficacy|48.8|||||TWO_SIDED|95.0|25.8|64.7|||||Not formally tested, since the first primary outcome was not met|||64.7|25.8|
71114505|NCT04925076|141737197|SUPERIORITY|||||||0.76|||||||ANOVA|F(1,93)=0.09||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hippocampus activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.76
71114506|NCT04925076|141737197|SUPERIORITY|||||||0.09|||||||ANOVA|F(1,93)=3.00||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hippocampus activation. Here we report the results of the analysis of the condition X sex interaction.||||.09
70852985|NCT00797966|141194660|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.06||||0.8007|TWO_SIDED|95.0|0.69|1.61||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||1.61|0.69|0.8007
70939652|NCT03320941|141380023|OTHER|Dose Finding|Mean Difference (Final Values)|-0.826|STANDARD_ERROR_OF_MEAN|0.1831|<|0.001|TWO_SIDED|95.0|-1.188|-0.463|||ANCOVA|||Overall Study||-0.463|-1.188|<0.001
70939653|NCT03320941|141380023|OTHER|Dose Finding|Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.2054||0.293|TWO_SIDED|95.0|-0.194|0.631|||ANCOVA|||Dysglycemic||0.631|-0.194|0.293
70852986|NCT00797966|141194660|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.03||||0.8945|TWO_SIDED|95.0|0.71|1.49||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||1.49|0.71|0.8945
70852987|NCT00797966|141194660|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.17||||0.3837|TWO_SIDED|95.0|0.83|1.64||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||1.64|0.83|0.3837
71071816|NCT03197324|141652008|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Ratio of Geometric LSM|100.4|||||TWO_SIDED|90.0|86.49|116.56|||||Digoxin group is the denominator and Digoxin with Bexagliflozin is the numerator. Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subjects as a random effect.|Geometric LS Mean was used as PK parameters||116.56|86.49|
70939654|NCT03320941|141380023|OTHER|Dose Finding|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.2068||0.665|TWO_SIDED|95.0|-0.325|0.506|||ANCOVA|||Dysglycemic||0.506|-0.325|0.665
70939655|NCT03320941|141380023|OTHER|Dose Finding|Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.1791||0.803|TWO_SIDED|95.0|-0.405|0.315|||ANCOVA|||Dysglycemic||0.315|-0.405|0.803
70939656|NCT03320941|141380023|OTHER|Dose Finding|Mean Difference (Final Values)|-0.256|STANDARD_ERROR_OF_MEAN|0.1787||0.159|TWO_SIDED|95.0|-0.615|0.103|||ANCOVA|||Dysglycemic||0.103|-0.615|0.159
70939657|NCT03320941|141380023|OTHER|Dose Finding|Mean Difference (Final Values)|-0.527|STANDARD_ERROR_OF_MEAN|0.3249||0.11|TWO_SIDED|95.0|-1.176|0.122|||ANCOVA|||T2DM||0.122|-1.176|0.110
70939658|NCT03320941|141380023|OTHER|Dose Finding|Mean Difference (Final Values)|-1.032|STANDARD_ERROR_OF_MEAN|0.3296||0.003|TWO_SIDED|95.0|-1.691|-0.373|||ANCOVA|||T2DM||-0.373|-1.691|0.003
70939659|NCT03320941|141380023|OTHER|Dose Finding|Mean Difference (Final Values)|-1.065|STANDARD_ERROR_OF_MEAN|0.2946|<|0.001|TWO_SIDED|95.0|-1.654|-0.476|||ANCOVA|||T2DM||-0.476|-1.654|<0.001
70939660|NCT03320941|141380023|OTHER|Dose Finding|Mean Difference (Final Values)|-1.298|STANDARD_ERROR_OF_MEAN|0.2855|<|0.001|TWO_SIDED|95.0|-1.869|-0.728|||ANCOVA|||T2DM||-0.728|-1.869|<0.001
71071817|NCT03197324|141652011|SUPERIORITY|Compare if co-administration of digoxin with bexagliflozin had significant impact on the PK of digoxin|Ratio of Geometric LSM|106.12|||||TWO_SIDED|90.0|95.82|117.53|||||Digoxin group is the denominator and Digoxin with Bexagliflozin is the numerator. Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subjects as a random effect.|Geometric LS Mean was used as PK parameters||117.53|95.82|
71071818|NCT04464720|141652057|OTHER|||||||0.05|||||||Wilcoxon Ranked Sum|||comparing pre and post intervention PM2.5||||0.050
71071819|NCT04464720|141652060|OTHER|||||||0.043|||||||Wilcoxon Ranked Sum|||comparing pre v post intervention NO2||||0.043
71071820|NCT04464720|141652063|OTHER|||||||0.056|||||||Wilcoxon Ranked Sum|||comparing FVC pre and post intervention||||0.056
71071821|NCT04464720|141652064|OTHER|||||||0.058|||||||Wilcoxon Signed Rank|||Comparing FEV1 pre and post intervention||||0.058
71114507|NCT04925076|141737197|SUPERIORITY|||||||0.76|||||||ANOVA|F(1,93)=0.10||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hippocampus activation. Here we report the results of the analysis of the condition X family history interaction.||||.76
71114508|NCT04925076|141737197|SUPERIORITY|||||||0.77|||||||ANOVA|F(1,93)=0.09||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hippocampus activation. Here we report the results of the analysis of the family history X sex interaction.||||.77
70939661|NCT03320941|141380024|OTHER|Dose Finding|Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|2.707||0.865|TWO_SIDED|95.0|-4.898|5.822|||ANCOVA|||Overall Study||5.822|-4.898|0.865
70939662|NCT03320941|141380024|OTHER|Dose Finding|Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|2.765||0.931|TWO_SIDED|95.0|-5.235|5.716|||ANCOVA|||Overall Study||5.716|-5.235|0.931
70939663|NCT03320941|141380024|OTHER|Dose Finding|Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|2.433||0.682|TWO_SIDED|95.0|-5.817|3.82|||ANCOVA|||Overall Study||3.820|-5.817|0.682
70939664|NCT03320941|141380024|OTHER|Dose Finding|Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|2.387||0.508|TWO_SIDED|95.0|-6.312|3.142|||ANCOVA|||Overall Study||3.142|-6.312|0.508
70939665|NCT03320941|141380024|OTHER|Dose Finding|Mean Difference (Final Values)|1.31|STANDARD_ERROR_OF_MEAN|4.206||0.757|TWO_SIDED|95.0|-7.138|9.749|||ANCOVA|||Dysglycemic||9.749|-7.138|0.757
70939666|NCT03320941|141380024|OTHER|Dose Finding|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|4.267||0.999|TWO_SIDED|95.0|-8.571|8.563|||ANCOVA|||Dysglycemic||8.563|-8.571|0.999
70939667|NCT03320941|141380024|OTHER|Dose Finding|Mean Difference (Final Values)|3.52|STANDARD_ERROR_OF_MEAN|3.668||0.342|TWO_SIDED|95.0|-3.848|10.88|||ANCOVA|||Dysglycemic||10.880|-3.848|0.342
70939668|NCT03320941|141380024|OTHER|Dose Finding|Mean Difference (Final Values)|2.92|STANDARD_ERROR_OF_MEAN|3.673||0.43|TWO_SIDED|95.0|-4.454|10.292|||ANCOVA|||Dysglycemic||10.292|-4.454|0.430
70939669|NCT03320941|141380024|OTHER|Dose Finding|Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|3.461||0.909|TWO_SIDED|95.0|-7.312|6.52|||ANCOVA|||T2DM||6.520|-7.312|0.909
70939670|NCT03320941|141380024|OTHER|Dose Finding|Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|3.563||0.821|TWO_SIDED|95.0|-6.311|7.93|||ANCOVA|||T2DM||7.930|-6.311|0.821
70939671|NCT03320941|141380024|OTHER|Dose Finding|Mean Difference (Final Values)|-4.87|STANDARD_ERROR_OF_MEAN|3.19||0.132|TWO_SIDED|95.0|-11.24|1.508|||ANCOVA|||T2DM||1.508|-11.240|0.132
71071822|NCT04464720|141652066|OTHER|||||||0.058|||||||Wilcoxon Ranked Sum|||comparing FeNO pre v post intervention||||0.058
71071823|NCT02156895|141652084|OTHER||Odds Ratio (OR)|1.1||||0.1244|TWO_SIDED|95.0|0.97|1.24|||Regression, Logistic|Multiple logistic regression including total duration of treatment with Inlyta as factor||||1.24|0.97|0.1244
71071824|NCT02156895|141652090|OTHER||Odds Ratio (OR)|1.11||||0.0109|TWO_SIDED|95.0|1.02|1.2|||Regression, Logistic|Multiple logistic regression including total duration of treatment with Inlyta as factor||||1.2|1.02|0.0109
71071825|NCT05537792|141652101|OTHER|Paired t-tests were used to compare the offline forward estimation error of each adapted forward estimator with the baseline during overground walking.||||||0.579|||||||t-test, 1 sided|||||||0.579
71071826|NCT05537792|141652101|OTHER|Paired t-tests were used to compare the offline forward estimation error of each adapted forward estimator with the baseline during overground walking.||||||0.0008|||||||t-test, 1 sided|||||||0.0008
71071827|NCT05537792|141652101|OTHER|Paired t-tests were used to compare the offline forward estimation error of each adapted forward estimator with the baseline during overground walking.||||||0.5513|||||||t-test, 1 sided|||||||0.5513
71071828|NCT05537792|141652101|OTHER|Paired t-tests were used to compare the offline forward estimation error of each adapted forward estimator with the baseline during overground walking.||||||0.00034|||||||t-test, 1 sided|||||||0.00034
71114509|NCT04925076|141737197|SUPERIORITY|||||||0.52|||||||ANOVA|F(1,93)=0.41||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hippocampus activation. Here we report the results of the analysis of the main effect of condition.||||.52
70939672|NCT03320941|141380024|OTHER|Dose Finding|Mean Difference (Final Values)|-5.23|STANDARD_ERROR_OF_MEAN|3.07||0.093|TWO_SIDED|95.0|-11.367|0.905|||ANCOVA|||T2DM||0.905|-11.367|0.093
70939673|NCT03320941|141380025|OTHER|Dose Finding|Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|2.013||0.769|TWO_SIDED|95.0|-4.579|3.393|||ANCOVA|||Overall Study||3.393|-4.579|0.769
70939674|NCT03320941|141380025|OTHER|Dose Finding|Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|2.043||0.839|TWO_SIDED|95.0|-4.462|3.63|||ANCOVA|||Overall Study||3.630|-4.462|0.839
70939675|NCT03320941|141380025|OTHER|Dose Finding|Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|1.807||0.496|TWO_SIDED|95.0|-4.811|2.345|||ANCOVA|||Overall Study||2.345|-4.811|0.496
70939676|NCT03320941|141380025|OTHER|Dose Finding|Mean Difference (Final Values)|-2.11|STANDARD_ERROR_OF_MEAN|1.774||0.237|TWO_SIDED|95.0|-5.622|1.402|||ANCOVA|||Overall Study||1.402|-5.622|0.237
70939677|NCT03320941|141380025|OTHER|Dose Finding|Mean Difference (Final Values)|0.99|STANDARD_ERROR_OF_MEAN|3.2||0.758|TWO_SIDED|95.0|-5.435|7.415|||ANCOVA|||Dysglycemic||7.415|-5.435|0.758
70939678|NCT03320941|141380025|OTHER|Dose Finding|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|3.23||0.978|TWO_SIDED|95.0|-6.574|6.397|||ANCOVA|||Dysglycemic||6.397|-6.574|0.978
70939679|NCT03320941|141380025|OTHER|Dose Finding|Mean Difference (Final Values)|1.84|STANDARD_ERROR_OF_MEAN|2.79||0.512|TWO_SIDED|95.0|-3.758|7.444|||ANCOVA|||Dysglycemic||7.444|-3.758|0.512
70939680|NCT03320941|141380025|OTHER|Dose Finding|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|2.792||0.985|TWO_SIDED|95.0|-5.552|5.657|||ANCOVA|||Dysglycemic||5.657|-5.552|0.985
70939681|NCT03320941|141380025|OTHER|Dose Finding|Mean Difference (Final Values)|-2.07|STANDARD_ERROR_OF_MEAN|2.599||0.428|TWO_SIDED|95.0|-7.268|3.121|||ANCOVA|||T2DM||3.121|-7.268|0.428
71071829|NCT03495154|141652109|OTHER|This was not a comparative endpoint.|Percentage and confidence interval|3.3|||||TWO_SIDED|95.0|1.0|8.5||||||Number of participants with hernia recurrence within 12 months following Parietene™ DS Composite Mesh use in ventral hernia repair||8.5|1.0|
70939682|NCT03320941|141380025|OTHER|Dose Finding|Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|2.669||0.846|TWO_SIDED|95.0|-5.853|4.812|||ANCOVA|||T2DM||4.812|-5.853|0.846
70939683|NCT03320941|141380025|OTHER|Dose Finding|Mean Difference (Final Values)|-4.05|STANDARD_ERROR_OF_MEAN|2.388||0.095|TWO_SIDED|95.0|-8.825|0.721|||ANCOVA|||T2DM||0.721|-8.825|0.095
70939684|NCT03320941|141380025|OTHER|Dose Finding|Mean Difference (Final Values)|-3.99|STANDARD_ERROR_OF_MEAN|2.31||0.089|TWO_SIDED|95.0|-8.61|0.623|||ANCOVA|||T2DM||0.623|-8.610|0.089
70939685|NCT03320941|141380026|OTHER|Dose Finding|Mean Difference (Final Values)|-15.561|STANDARD_ERROR_OF_MEAN|21.4808||0.47|TWO_SIDED|95.0|-58.106|26.985|||ANCOVA|||Overall Study||26.985|-58.106|0.470
70939686|NCT03320941|141380026|OTHER|Dose Finding|Mean Difference (Final Values)|-6.343|STANDARD_ERROR_OF_MEAN|21.6316||0.77|TWO_SIDED|95.0|-49.187|36.501|||ANCOVA|||Overall Study||36.501|-49.187|0.770
70939687|NCT03320941|141380026|OTHER|Dose Finding|Mean Difference (Final Values)|26.527|STANDARD_ERROR_OF_MEAN|19.1803||0.169|TWO_SIDED|95.0|-11.462|64.516|||ANCOVA|||Overall Study||64.516|-11.462|0.169
70939688|NCT03320941|141380026|OTHER|Dose Finding|Mean Difference (Final Values)|-12.094|STANDARD_ERROR_OF_MEAN|18.8076||0.521|TWO_SIDED|95.0|-49.345|25.157|||ANCOVA|||Overall Study||25.157|-49.345|0.521
70939689|NCT03320941|141380026|OTHER|Dose Finding|Mean Difference (Final Values)|-22.115|STANDARD_ERROR_OF_MEAN|38.7858||0.571|TWO_SIDED|95.0|-100.058|55.828|||ANCOVA|||Dysglycemic||55.828|-100.058|0.571
70939690|NCT03320941|141380026|OTHER|Dose Finding|Mean Difference (Final Values)|-22.948|STANDARD_ERROR_OF_MEAN|39.4994||0.564|TWO_SIDED|95.0|-102.325|56.429|||ANCOVA|||Dysglycemic||56.429|-102.325|0.564
70939691|NCT03320941|141380026|OTHER|Dose Finding|Mean Difference (Final Values)|31.322|STANDARD_ERROR_OF_MEAN|33.855||0.359|TWO_SIDED|95.0|-36.712|99.356|||ANCOVA|||Dysglycemic||99.356|-36.712|0.359
71071830|NCT03495154|141652110|OTHER|Statistical Analysis is based on number of participants with incidence of with ADEs at discharge. Adverse Device Effects (ADE) is inclusive of both procedure and/or device related AEs.|Number of Subjects with ADEs|14.0|||||TWO_SIDED|||||||||||||
71071831|NCT03495154|141652110|OTHER|Statistical Analysis is based on number of participants with incidence of ADEs within 1 month. Adverse Device Effects (ADE) is inclusive of both procedure and/or device related AEs.|Number of Subjects with ADEs|31.0|||||TWO_SIDED|||||||||||||
70939692|NCT03320941|141380026|OTHER|Dose Finding|Mean Difference (Final Values)|-6.901|STANDARD_ERROR_OF_MEAN|34.4309||0.842|TWO_SIDED|95.0|-76.093|62.29|||ANCOVA|||Dysglycemic||62.290|-76.093|0.842
70939693|NCT03320941|141380026|OTHER|Dose Finding|Mean Difference (Final Values)|-12.79|STANDARD_ERROR_OF_MEAN|24.3259||0.601|TWO_SIDED|95.0|-61.417|35.836|||ANCOVA|||T2DM||35.836|-61.417|0.601
70939694|NCT03320941|141380026|OTHER|Dose Finding|Mean Difference (Final Values)|9.302|STANDARD_ERROR_OF_MEAN|24.422||0.705|TWO_SIDED|95.0|-39.517|58.121|||ANCOVA|||T2DM||58.121|-39.517|0.705
70939695|NCT03320941|141380026|OTHER|Dose Finding|Mean Difference (Final Values)|20.94|STANDARD_ERROR_OF_MEAN|22.0444||0.346|TWO_SIDED|95.0|-23.126|65.007|||ANCOVA|||T2DM||65.007|-23.126|0.346
70939696|NCT03320941|141380026|OTHER|Dose Finding|Mean Difference (Final Values)|-13.863|STANDARD_ERROR_OF_MEAN|21.2205||0.516|TWO_SIDED|95.0|-56.283|28.556|||ANCOVA|||T2DM||28.556|-56.283|0.516
70939697|NCT03320941|141380027|OTHER|Dose Finding|Mean Difference (Final Values)|0.955|STANDARD_ERROR_OF_MEAN|3.605||0.792|TWO_SIDED|95.0|-6.185|8.095|||ANCOVA|||Overall Study||8.095|-6.185|0.792
70939698|NCT03320941|141380027|OTHER|Dose Finding|Mean Difference (Final Values)|-0.739|STANDARD_ERROR_OF_MEAN|3.7167||0.843|TWO_SIDED|95.0|-8.1|6.623|||ANCOVA|||Overall Study||6.623|-8.100|0.843
70939699|NCT03320941|141380027|OTHER|Dose Finding|Mean Difference (Final Values)|3.128|STANDARD_ERROR_OF_MEAN|3.2564||0.339|TWO_SIDED|95.0|-3.322|9.578|||ANCOVA|||Overall Study||9.578|-3.322|0.339
70939700|NCT03320941|141380027|OTHER|Dose Finding|Mean Difference (Final Values)|2.546|STANDARD_ERROR_OF_MEAN|3.1859||0.426|TWO_SIDED|95.0|-3.764|8.856|||ANCOVA|||Overall Study||8.856|-3.764|0.426
70939701|NCT03320941|141380027|OTHER|Dose Finding|Mean Difference (Final Values)|0.504|STANDARD_ERROR_OF_MEAN|5.8734||0.932|TWO_SIDED|95.0|-11.299|12.307|||ANCOVA|||Dysglycemic||12.307|-11.299|0.932
70939702|NCT03320941|141380027|OTHER|Dose Finding|Mean Difference (Final Values)|-2.458|STANDARD_ERROR_OF_MEAN|6.3493||0.7|TWO_SIDED|95.0|-15.217|10.302|||ANCOVA|||Dysglycemic||10.302|-15.217|0.700
70939703|NCT03320941|141380027|OTHER|Dose Finding|Mean Difference (Final Values)|7.832|STANDARD_ERROR_OF_MEAN|5.0946||0.131|TWO_SIDED|95.0|-2.406|18.07|||ANCOVA|||Dysglycemic||18.070|-2.406|0.131
70939704|NCT03320941|141380027|OTHER|Dose Finding|Mean Difference (Final Values)|1.825|STANDARD_ERROR_OF_MEAN|5.197||0.727|TWO_SIDED|95.0|-8.619|12.269|||ANCOVA|||Dysglycemic||12.269|-8.619|0.727
70939705|NCT03320941|141380027|OTHER|Dose Finding|Mean Difference (Final Values)|0.828|STANDARD_ERROR_OF_MEAN|4.5876||0.857|TWO_SIDED|95.0|-8.342|9.999|||ANCOVA|||T2DM||9.999|-8.342|0.857
70939706|NCT03320941|141380027|OTHER|Dose Finding|Mean Difference (Final Values)|-0.696|STANDARD_ERROR_OF_MEAN|4.7173||0.883|TWO_SIDED|95.0|-10.126|8.734|||ANCOVA|||T2DM||8.734|-10.126|0.883
71071832|NCT03495154|141652110|OTHER|Statistical Analysis is based on number of participants with incidence of ADEs within 3 months. Adverse Device Effects (ADE) is inclusive of both procedure and/or device related AEs.|Number of Subjects with ADEs|34.0|||||TWO_SIDED|||||||||||||
71071833|NCT03495154|141652110|OTHER|Statistical Analysis is based on number of participants with incidence of ADEs within 12 months. Adverse Device Effects (ADE) is inclusive of both procedure and/or device related AEs.|Number of Subjects with ADEs|40.0|||||TWO_SIDED|||||||||||||
71071834|NCT03495154|141652110|OTHER|Statistical Analysis is based on number of participants with incidence of ADEs within 24 months. Adverse Device Effects (ADEs) are inclusive of both procedure and device related AEs.|Number of Subjects with ADEs|42.0|||||TWO_SIDED|||||||||||||
71071835|NCT03495154|141652111|OTHER|This was not a comparative endpoint.|% of Subjects with Recurrence within 1M|0.0|||||TWO_SIDED|95.0|0.0|2.9||||||||2.9|0|
71071836|NCT03495154|141652111|OTHER|This was not a comparative endpoint.|% of Subjects with Recurrence within 3M|0.0|||||TWO_SIDED|95.0|0.0|3.0||||||||3.0|0|
71071837|NCT03495154|141652111|OTHER|This was not a comparative endpoint.|% of Subjects with Recurrence within 24M|4.0|||||TWO_SIDED|95.0|1.2|9.6||||||||9.6|1.2|
71071838|NCT05633992|141652140|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.75|1.17|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 3||1.17|0.75|<0.001
71071839|NCT05633992|141652140|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.88|1.33|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 7F||1.33|0.88|<0.001
71071840|NCT05633992|141652140|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.12|||<|0.001|TWO_SIDED|95.0|0.93|1.36|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 8||1.36|0.93|<0.001
71071841|NCT05633992|141652140|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.86|1.29|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 9N||1.29|0.86|<0.001
71071842|NCT05633992|141652140|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.65|||<|0.001|TWO_SIDED|95.0|1.28|2.14|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 10A||2.14|1.28|<0.001
71071843|NCT05633992|141652140|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.52|||<|0.001|TWO_SIDED|95.0|1.2|1.92|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 11A||1.92|1.20|<0.001
71071844|NCT05633992|141652140|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.97|||<|0.001|TWO_SIDED|95.0|1.43|2.72|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 12F||2.72|1.43|<0.001
70939707|NCT03320941|141380027|OTHER|Dose Finding|Mean Difference (Final Values)|-0.975|STANDARD_ERROR_OF_MEAN|4.2883||0.821|TWO_SIDED|95.0|-9.547|7.597|||ANCOVA|||T2DM||7.597|-9.547|0.821
70939708|NCT03320941|141380027|OTHER|Dose Finding|Mean Difference (Final Values)|2.488|STANDARD_ERROR_OF_MEAN|4.1111||0.547|TWO_SIDED|95.0|-5.73|10.706|||ANCOVA|||T2DM||10.706|-5.730|0.547
70939709|NCT03320941|141380028|OTHER|Dose Finding|Mean Difference (Final Values)|4.954|STANDARD_ERROR_OF_MEAN|3.4006||0.148|TWO_SIDED|95.0|-1.781|11.689|||ANCOVA|||Overall Study||11.689|-1.781|0.148
70939710|NCT03320941|141380028|OTHER|Dose Finding|Mean Difference (Final Values)|0.993|STANDARD_ERROR_OF_MEAN|3.4645||0.775|TWO_SIDED|95.0|-5.869|7.855|||ANCOVA|||Overall Study||7.855|-5.869|0.775
70939711|NCT03320941|141380028|OTHER|Dose Finding|Mean Difference (Final Values)|-1.799|STANDARD_ERROR_OF_MEAN|3.0432||0.556|TWO_SIDED|95.0|-7.826|4.229|||ANCOVA|||Overall Study||4.229|-7.826|0.556
70939712|NCT03320941|141380028|OTHER|Dose Finding|Mean Difference (Final Values)|3.566|STANDARD_ERROR_OF_MEAN|3.0079||0.238|TWO_SIDED|95.0|-2.391|9.524|||ANCOVA|||Overall Study||9.524|-2.391|0.238
70939713|NCT03320941|141380028|OTHER|Dose Finding|Mean Difference (Final Values)|3.811|STANDARD_ERROR_OF_MEAN|5.4552||0.488|TWO_SIDED|95.0|-7.152|14.774|||ANCOVA|||Dysglycemic||14.774|-7.152|0.488
70939714|NCT03320941|141380028|OTHER|Dose Finding|Mean Difference (Final Values)|4.659|STANDARD_ERROR_OF_MEAN|5.4845||0.4|TWO_SIDED|95.0|-6.363|15.68|||ANCOVA|||Dysglycemic||15.680|-6.363|0.400
71071845|NCT05633992|141652140|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.6|||<|0.001|TWO_SIDED|95.0|1.28|2.0|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 17F||2.00|1.28|<0.001
71071846|NCT05633992|141652140|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.16|||<|0.001|TWO_SIDED|95.0|0.93|1.45|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 19A||1.45|0.93|<0.001
70939715|NCT03320941|141380028|OTHER|Dose Finding|Mean Difference (Final Values)|1.05|STANDARD_ERROR_OF_MEAN|4.7651||0.826|TWO_SIDED|95.0|-8.525|10.626|||ANCOVA|||Dysglycemic||10.626|-8.525|0.826
70939716|NCT03320941|141380028|OTHER|Dose Finding|Mean Difference (Final Values)|4.182|STANDARD_ERROR_OF_MEAN|4.7627||0.384|TWO_SIDED|95.0|-5.389|13.753|||ANCOVA|||Dysglycemic||13.753|-5.389|0.384
70939717|NCT03320941|141380028|OTHER|Dose Finding|Mean Difference (Final Values)|5.563|STANDARD_ERROR_OF_MEAN|4.4636||0.217|TWO_SIDED|95.0|-3.36|14.486|||ANCOVA|||T2DM||14.486|-3.360|0.217
70939718|NCT03320941|141380028|OTHER|Dose Finding|Mean Difference (Final Values)|-2.019|STANDARD_ERROR_OF_MEAN|4.5491||0.659|TWO_SIDED|95.0|-11.112|7.074|||ANCOVA|||T2DM||7.074|-11.112|0.659
70939719|NCT03320941|141380028|OTHER|Dose Finding|Mean Difference (Final Values)|-4.316|STANDARD_ERROR_OF_MEAN|4.0556||0.291|TWO_SIDED|95.0|-12.423|3.791|||ANCOVA|||T2DM||3.791|-12.423|0.291
70939720|NCT03320941|141380028|OTHER|Dose Finding|Mean Difference (Final Values)|2.913|STANDARD_ERROR_OF_MEAN|4.0035||0.47|TWO_SIDED|95.0|-5.09|10.916|||ANCOVA|||T2DM||10.916|-5.090|0.470
70939721|NCT03320941|141380029|OTHER|Dose Finding|Mean Difference (Final Values)|1.308|STANDARD_ERROR_OF_MEAN|5.2049||0.802|TWO_SIDED|95.0|-9.001|11.617|||ANCOVA|||Overall Study||11.617|-9.001|0.802
70939722|NCT03320941|141380029|OTHER|Dose Finding|Mean Difference (Final Values)|-1.812|STANDARD_ERROR_OF_MEAN|5.4301||0.739|TWO_SIDED|95.0|-12.567|8.943|||ANCOVA|||Overall Study||8.943|-12.567|0.739
70939723|NCT03320941|141380029|OTHER|Dose Finding|Mean Difference (Final Values)|0.588|STANDARD_ERROR_OF_MEAN|4.7125||0.901|TWO_SIDED|95.0|-8.745|9.922|||ANCOVA|||Overall Study||9.922|-8.745|0.901
70939724|NCT03320941|141380029|OTHER|Dose Finding|Mean Difference (Final Values)|5.278|STANDARD_ERROR_OF_MEAN|4.6095||0.255|TWO_SIDED|95.0|-3.852|14.407|||ANCOVA|||Overall Study||14.407|-3.852|0.255
70939725|NCT03320941|141380029|OTHER|Dose Finding|Mean Difference (Final Values)|0.928|STANDARD_ERROR_OF_MEAN|8.5585||0.914|TWO_SIDED|95.0|-16.271|18.127|||ANCOVA|||Dysglycemic||18.127|-16.271|0.914
70939726|NCT03320941|141380029|OTHER|Dose Finding|Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|9.2308||0.959|TWO_SIDED|95.0|-19.03|18.07|||ANCOVA|||Dysglycemic||18.070|-19.030|0.959
70939727|NCT03320941|141380029|OTHER|Dose Finding|Mean Difference (Final Values)|6.572|STANDARD_ERROR_OF_MEAN|7.422||0.38|TWO_SIDED|95.0|-8.343|21.487|||ANCOVA|||Dysglycemic||21.487|-8.343|0.380
70939728|NCT03320941|141380029|OTHER|Dose Finding|Mean Difference (Final Values)|6.121|STANDARD_ERROR_OF_MEAN|7.5174||0.419|TWO_SIDED|95.0|-8.986|21.228|||ANCOVA|||Dysglycemic||21.228|-8.986|0.419
70939729|NCT03320941|141380029|OTHER|Dose Finding|Mean Difference (Final Values)|0.785|STANDARD_ERROR_OF_MEAN|6.6209||0.906|TWO_SIDED|95.0|-12.45|14.02|||ANCOVA|||T2DM||14.020|-12.450|0.906
70939730|NCT03320941|141380029|OTHER|Dose Finding|Mean Difference (Final Values)|-4.504|STANDARD_ERROR_OF_MEAN|6.8489||0.513|TWO_SIDED|95.0|-18.195|9.187|||ANCOVA|||T2DM||9.187|-18.195|0.513
70939731|NCT03320941|141380029|OTHER|Dose Finding|Mean Difference (Final Values)|-4.237|STANDARD_ERROR_OF_MEAN|6.23||0.499|TWO_SIDED|95.0|-16.691|8.216|||ANCOVA|||T2DM||8.216|-16.691|0.499
70939732|NCT03320941|141380029|OTHER|Dose Finding|Mean Difference (Final Values)|3.86|STANDARD_ERROR_OF_MEAN|5.9073||0.516|TWO_SIDED|95.0|-7.948|15.669|||ANCOVA|||T2DM||15.669|-7.948|0.516
70939733|NCT03320941|141380030|OTHER|Dose Finding|Mean Difference (Final Values)|44.82||||0.625|TWO_SIDED|95.0|-136.644|226.284|||ANCOVA|||Overall Study||226.284|-136.644|0.625
70939734|NCT03320941|141380030|OTHER|Dose Finding|Mean Difference (Final Values)|162.273||||0.079|TWO_SIDED|95.0|-19.326|343.871|||ANCOVA|||Overall Study||343.871|-19.326|0.079
70939735|NCT03320941|141380030|OTHER|Dose Finding|Mean Difference (Final Values)|69.062||||0.384|TWO_SIDED|95.0|-87.493|225.617|||ANCOVA|||Overall Study||225.617|-87.493|0.384
70939736|NCT03320941|141380030|OTHER|Dose Finding|Mean Difference (Final Values)|37.733||||0.627|TWO_SIDED|95.0|-115.58|191.045|||ANCOVA|||Overall Study||191.045|-115.580|0.627
70939737|NCT03320941|141380030|OTHER|Dose Finding|Mean Difference (Final Values)|22.879||||0.797|TWO_SIDED|95.0|-155.244|201.003|||ANCOVA|||Dysglycemic||201.003|-155.244|0.797
70939738|NCT03320941|141380030|OTHER|Dose Finding|Mean Difference (Final Values)|12.891||||0.882|TWO_SIDED|95.0|-160.215|185.996|||ANCOVA|||Dysglycemic||185.996|-160.215|0.882
70939739|NCT03320941|141380030|OTHER|Dose Finding|Mean Difference (Final Values)|-30.447||||0.675|TWO_SIDED|95.0|-175.796|114.902|||ANCOVA|||Dysglycemic||114.902|-175.796|0.675
71071847|NCT05633992|141652140|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.44|||<|0.001|TWO_SIDED|95.0|1.18|1.77|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 20A||1.77|1.18|<0.001
71071848|NCT05633992|141652140|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.39|||<|0.001|TWO_SIDED|95.0|1.1|1.76|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 22F||1.76|1.10|<0.001
71071849|NCT05633992|141652140|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|0.87|||<|0.001|TWO_SIDED|95.0|0.68|1.12|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 33F||1.12|0.68|<0.001
70852988|NCT00797966|141194660|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.09||||0.7064|TWO_SIDED|95.0|0.72|1.63||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||1.63|0.72|0.7064
70939740|NCT03320941|141380030|OTHER|Dose Finding|Mean Difference (Final Values)|-37.264||||0.607|TWO_SIDED|95.0|-182.099|107.571|||ANCOVA|||Dysglycemic||107.571|-182.099|0.607
70852989|NCT00797966|141194660|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.06||||0.7469|TWO_SIDED|95.0|0.74|1.52||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||1.52|0.74|0.7469
70939741|NCT03320941|141380030|OTHER|Dose Finding|Mean Difference (Final Values)|84.822||||0.591|TWO_SIDED|95.0|-229.131|398.775|||ANCOVA|||T2DM||398.775|-229.131|0.591
70939742|NCT03320941|141380030|OTHER|Dose Finding|Mean Difference (Final Values)|287.328||||0.066|TWO_SIDED|95.0|-19.533|594.19|||ANCOVA|||T2DM||594.190|-19.533|0.066
70939743|NCT03320941|141380030|OTHER|Dose Finding|Mean Difference (Final Values)|156.017||||0.252|TWO_SIDED|95.0|-113.963|425.997|||ANCOVA|||T2DM||425.997|-113.963|0.252
70939744|NCT03320941|141380030|OTHER|Dose Finding|Mean Difference (Final Values)|103.135||||0.431|TWO_SIDED|95.0|-157.287|363.556|||ANCOVA|||T2DM||363.556|-157.287|0.431
70939745|NCT03320941|141380031|OTHER|Dose Finding|Mean Difference (Final Values)|-65.1|STANDARD_ERROR_OF_MEAN|13.03|<|0.001|TWO_SIDED|95.0|-90.864|-39.251|||ANCOVA|||Overall Study||-39.251|-90.864|<0.001
70939746|NCT03320941|141380031|OTHER|Dose Finding|Mean Difference (Final Values)|-67.7|STANDARD_ERROR_OF_MEAN|13.21|<|0.001|TWO_SIDED|95.0|-93.848|-41.542|||ANCOVA|||Overall Study||-41.542|-93.848|<0.001
70939747|NCT03320941|141380031|OTHER|Dose Finding|Mean Difference (Final Values)|-70.8|STANDARD_ERROR_OF_MEAN|11.67|<|0.001|TWO_SIDED|95.0|-93.942|-47.735|||ANCOVA|||Overall Study||-47.735|-93.942|<0.001
70939748|NCT03320941|141380031|OTHER|Dose Finding|Mean Difference (Final Values)|-74.4|STANDARD_ERROR_OF_MEAN|11.47|<|0.001|TWO_SIDED|95.0|-97.117|-51.704|||ANCOVA|||Overall Study||-51.704|-97.117|<0.001
70939749|NCT03320941|141380031|OTHER|Dose Finding|Mean Difference (Final Values)|-86.9|STANDARD_ERROR_OF_MEAN|24.35|<|0.001|TWO_SIDED|95.0|-135.78|-38.013|||ANCOVA|||Dysglycemic||-38.013|-135.780|<0.001
70939750|NCT03320941|141380031|OTHER|Dose Finding|Mean Difference (Final Values)|-86.1|STANDARD_ERROR_OF_MEAN|24.01|<|0.001|TWO_SIDED|95.0|-134.266|-37.874|||ANCOVA|||Dysglycemic||-37.874|-134.266|<0.001
70939751|NCT03320941|141380031|OTHER|Dose Finding|Mean Difference (Final Values)|-81.1|STANDARD_ERROR_OF_MEAN|21.04|<|0.001|TWO_SIDED|95.0|-123.369|-38.883|||ANCOVA|||Dysglycemic||-38.883|-123.369|<0.001
70939752|NCT03320941|141380031|OTHER|Dose Finding|Mean Difference (Final Values)|-84.9|STANDARD_ERROR_OF_MEAN|21.03|<|0.001|TWO_SIDED|95.0|-127.104|-42.669|||ANCOVA|||Dysglycemic||-42.669|-127.104|<0.001
70939753|NCT03320941|141380031|OTHER|Dose Finding|Mean Difference (Final Values)|-47.5|STANDARD_ERROR_OF_MEAN|13.52|<|0.001|TWO_SIDED|95.0|-74.493|-20.461|||ANCOVA|||T2DM||-20.461|-74.493|<0.001
70939754|NCT03320941|141380031|OTHER|Dose Finding|Mean Difference (Final Values)|-53.1|STANDARD_ERROR_OF_MEAN|13.93|<|0.001|TWO_SIDED|95.0|-80.914|-25.251|||ANCOVA|||T2DM||-25.251|-80.914|<0.001
70939755|NCT03320941|141380031|OTHER|Dose Finding|Mean Difference (Final Values)|-61.8|STANDARD_ERROR_OF_MEAN|12.43|<|0.001|TWO_SIDED|95.0|-86.627|-36.937|||ANCOVA|||T2DM||-36.937|-86.627|<0.001
70852990|NCT00797966|141194660|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.34||||0.0832|TWO_SIDED|95.0|0.97|1.86||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||1.86|0.97|0.0832
70939756|NCT03320941|141380031|OTHER|Dose Finding|Mean Difference (Final Values)|-65.0|STANDARD_ERROR_OF_MEAN|12.15|<|0.001|TWO_SIDED|95.0|-89.291|-40.713|||ANCOVA|||T2DM||-40.713|-89.291|<0.001
70939757|NCT03320941|141380032|OTHER|Dose Finding|Mean Difference (Final Values)|-0.556|STANDARD_ERROR_OF_MEAN|1.845||0.764|TWO_SIDED|95.0|-4.21|3.098|||ANCOVA|||Overall Study||3.098|-4.210|0.764
70939758|NCT03320941|141380032|OTHER|Dose Finding|Mean Difference (Final Values)|1.289|STANDARD_ERROR_OF_MEAN|1.8741||0.493|TWO_SIDED|95.0|-2.423|5.001|||ANCOVA|||Overall Study||5.001|-2.423|0.493
70939759|NCT03320941|141380032|OTHER|Dose Finding|Mean Difference (Final Values)|-2.621|STANDARD_ERROR_OF_MEAN|1.6596||0.117|TWO_SIDED|95.0|-5.908|0.666|||ANCOVA|||Overall Study||0.666|-5.908|0.117
70939760|NCT03320941|141380032|OTHER|Dose Finding|Mean Difference (Final Values)|-1.818|STANDARD_ERROR_OF_MEAN|1.6349||0.269|TWO_SIDED|95.0|-5.056|1.421|||ANCOVA|||Overall Study||1.421|-5.056|0.269
70939761|NCT03320941|141380032|OTHER|Dose Finding|Mean Difference (Final Values)|1.671|STANDARD_ERROR_OF_MEAN|1.1677||0.159|TWO_SIDED|95.0|-0.676|4.017|||ANCOVA|||Dysglycemic||4.017|-0.676|0.159
71071850|NCT05633992|141652140|NON_INFERIORITY|For serotype 15B, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.43|||<|0.001|TWO_SIDED|95.0|1.07|1.89|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 15B||1.89|1.07|<0.001
71071851|NCT05633992|141652140|SUPERIORITY|For serotype 15C, a conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>1.0 (one-sided p-value \<0.025).|Day 30 GMT Ratio|2.05|||<|0.001|TWO_SIDED|95.0|1.56|2.7|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 15C||2.70|1.56|<0.001
71071852|NCT05633992|141652141|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|27.6|||<|0.001|TWO_SIDED|95.0|17.8|36.9|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 6A||36.9|17.8|<0.001
71071853|NCT05633992|141652141|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|33.7|||<|0.001|TWO_SIDED|95.0|23.6|43.0|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 15A||43.0|23.6|<0.001
70939762|NCT03320941|141380032|OTHER|Dose Finding|Mean Difference (Final Values)|5.641|STANDARD_ERROR_OF_MEAN|1.1678|<|0.001|TWO_SIDED|95.0|3.294|7.988|||ANCOVA|||Dysglycemic||7.988|3.294|<0.001
70939763|NCT03320941|141380032|OTHER|Dose Finding|Mean Difference (Final Values)|1.155|STANDARD_ERROR_OF_MEAN|1.0371||0.271|TWO_SIDED|95.0|-0.929|3.239|||ANCOVA|||Dysglycemic||3.239|-0.929|0.271
70939764|NCT03320941|141380032|OTHER|Dose Finding|Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|1.019||0.841|TWO_SIDED|95.0|-1.842|2.253|||ANCOVA|||Dysglycemic||2.253|-1.842|0.841
70939765|NCT03320941|141380032|OTHER|Dose Finding|Mean Difference (Final Values)|-3.725|STANDARD_ERROR_OF_MEAN|2.518||0.144|TWO_SIDED|95.0|-8.758|1.309|||ANCOVA|||T2DM||1.309|-8.758|0.144
70852991|NCT00797966|141194660|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.09||||0.6611|TWO_SIDED|95.0|0.74|1.61||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||1.61|0.74|0.6611
70852992|NCT00797966|141194660|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.13||||0.4435|TWO_SIDED|95.0|0.83|1.56||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||1.56|0.83|0.4435
70852993|NCT00797966|141194660|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.47||||0.0118|TWO_SIDED|95.0|1.09|1.98||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||1.98|1.09|0.0118
70939766|NCT03320941|141380032|OTHER|Dose Finding|Mean Difference (Final Values)|-0.877|STANDARD_ERROR_OF_MEAN|2.5906||0.736|TWO_SIDED|95.0|-6.055|4.302|||ANCOVA|||T2DM||4.302|-6.055|0.736
70939767|NCT03320941|141380032|OTHER|Dose Finding|Mean Difference (Final Values)|-3.431|STANDARD_ERROR_OF_MEAN|2.3113||0.143|TWO_SIDED|95.0|-8.051|1.19|||ANCOVA|||T2DM||1.190|-8.051|0.143
70939768|NCT03320941|141380032|OTHER|Dose Finding|Mean Difference (Final Values)|-1.991|STANDARD_ERROR_OF_MEAN|2.2659||0.383|TWO_SIDED|95.0|-6.521|2.538|||ANCOVA|||T2DM||2.538|-6.521|0.383
70939769|NCT03320941|141380033|OTHER|Dose Finding|Mean Difference (Final Values)|0.654|STANDARD_ERROR_OF_MEAN|1.1543||0.572|TWO_SIDED|95.0|-1.632|2.941|||ANCOVA|||Overall Study||2.941|-1.632|0.572
70939770|NCT03320941|141380033|OTHER|Dose Finding|Mean Difference (Final Values)|0.655|STANDARD_ERROR_OF_MEAN|1.1738||0.578|TWO_SIDED|95.0|-1.67|2.98|||ANCOVA|||Overall Study||2.980|-1.670|0.578
70939771|NCT03320941|141380033|OTHER|Dose Finding|Mean Difference (Final Values)|-1.048|STANDARD_ERROR_OF_MEAN|1.0479||0.319|TWO_SIDED|95.0|-3.124|1.028|||ANCOVA|||Overall Study||1.028|-3.124|0.319
70939772|NCT03320941|141380033|OTHER|Dose Finding|Mean Difference (Final Values)|-0.374|STANDARD_ERROR_OF_MEAN|1.0303||0.717|TWO_SIDED|95.0|-2.416|1.667|||ANCOVA|||Overall Study||1.667|-2.416|0.717
70852994|NCT00797966|141194660|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.89||||0.5111|TWO_SIDED|95.0|0.63|1.26||Cochran-Mantel-Haenszel general association test controlling for study center.|Chi-squared, Corrected|||Week 14 values presented here.||1.26|0.63|0.5111
70852995|NCT00797966|141194660|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.9||||0.4903|TWO_SIDED|95.0|0.66|1.22||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||1.22|0.66|0.4903
70852996|NCT00797966|141194660|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.28||||0.0662|TWO_SIDED|95.0|0.98|1.67||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||1.67|0.98|0.0662
70852997|NCT03859973|141194661|OTHER||Mean Difference (Net)|-0.866||||0.3101|TWO_SIDED|95.0|-2.605|0.833|||Mixed Models Analysis||Least Square Mean of (BI 425809 10 mg + Computerized Cognitive Training) - Least Square Mean of (Placebo + Computerized Cognitive Training)|Restricted maximum likelihood (REML) based approach using a mixed model with repeated measurements (MMRM) which included the following fixed effects: categorical factor of planned treatment, visit (screening, baseline, week 6 and Week 12), planned treatment by visit interaction, continuous covariate of baseline value, baseline by visit interaction, categorical factor of age group, and continuous covariate of change from screening to baseline value.||0.833|-2.605|0.3101
70852998|NCT03859973|141194662|OTHER||Mean Difference (Net)|-1.051||||0.2309|TWO_SIDED|95.0|-2.778|0.676|||Mixed Models Analysis||Least Square Mean of (BI 425809 10 mg + Computerized Cognitive Training) - Least Square Mean of (Placebo + Computerized Cognitive Training)|Restricted maximum likelihood (REML) based approach using a mixed model with repeated measurements (MMRM) which included the following fixed effects: categorical factor of planned treatment, visit (screening, baseline, week 6 and Week 12), planned treatment by visit interaction, continuous covariate of baseline value, baseline by visit interaction, categorical factor of age group, and continuous covariate of change from screening to baseline value.||0.676|-2.778|0.2309
70852999|NCT03859973|141194663|OTHER||Mean Difference (Net)|0.577||||0.5237|TWO_SIDED|95.0|-1.207|2.362|||ANCOVA||Least Square Mean of (BI 425809 10 mg + Computerized Cognitive Training) - Least Square Mean of (Placebo + Computerized Cognitive Training)|Analysis of Covariance (ANCOVA) which included the following fixed effects: categorical factor of planned treatment, continuous covariate of baseline value, categorical factor of age group.||2.362|-1.207|0.5237
70853000|NCT03859973|141194664|OTHER||Mean Difference (Net)|-0.669||||0.642|TWO_SIDED|95.0|-3.51|2.172|||Mixed Models Analysis||Least Square Mean of (BI 425809 10 mg + Computerized Cognitive Training) - Least Square Mean of (Placebo + Computerized Cognitive Training)|Restricted maximum likelihood (REML) based approach using a mixed model with repeated measurements (MMRM) which included the following fixed effects: categorical factor of planned treatment, visit (baseline, Week 6 and Week 12), planned treatment by visit interaction, continuous covariate of baseline value, baseline by visit interaction, categorical factor of age group.||2.172|-3.510|0.6420
70853001|NCT01478048|141194666|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.0923|TWO_SIDED|95.0|0.49|1.06||Log Rank test was stratified by prior proteasome inhibitor use (Yes versus No), presence of at least 1 FcγRIIIa V allele (Yes versus No) and number of prior lines of therapy (1 versus 2 or 3) at randomization|Log Rank|Adjusted alpha level= 0.30||||1.06|0.49|0.0923
70853002|NCT01478048|141194669|SUPERIORITY_OR_OTHER||Difference using Chan-Zhang method|2.3|||||TWO_SIDED|95.0|-13.2|17.8||||||||17.8|-13.2|
70853003|NCT00955201|141194681|SUPERIORITY|||||||0.49||||||Tukey's multiple comparisons test|ANOVA|Comparison to baseline values||Evaluated within group across time||||0.49
70853004|NCT00955201|141194681|SUPERIORITY|||||||0.82||||||Tukey's multiple comparisons test|ANOVA|||Evaluated within group across time||||0.82
70853005|NCT00955201|141194681|SUPERIORITY|||||||0.96||||||Tukey's multiple comparisons test|ANOVA|||Evaluated within group across time||||0.96
70853006|NCT00955201|141194681|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test|ANOVA|||Evaluated within group across time||||0.93
70939773|NCT03320941|141380033|OTHER|Dose Finding|Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.563||0.317|TWO_SIDED|95.0|-0.562|1.701|||ANCOVA|||Dysglycemic||1.701|-0.562|0.317
71114510|NCT04925076|141737197|SUPERIORITY|||||||0.93|||||||ANOVA|F(1,93)=0.007||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain hippocampus activation. Here we report the results of the analysis of the main effect of family history.||||.93
70939774|NCT03320941|141380033|OTHER|Dose Finding|Mean Difference (Final Values)|1.609|STANDARD_ERROR_OF_MEAN|0.5716||0.007|TWO_SIDED|95.0|0.46|2.758|||ANCOVA|||Dysglycemic||2.758|0.460|0.007
70939775|NCT03320941|141380033|OTHER|Dose Finding|Mean Difference (Final Values)|0.352|STANDARD_ERROR_OF_MEAN|0.5029||0.487|TWO_SIDED|95.0|-0.659|1.362|||ANCOVA|||Dysglycemic||1.362|-0.659|0.487
71071854|NCT05633992|141652141|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|38.3|||<|0.001|TWO_SIDED|95.0|29.8|46.4|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 16F||46.4|29.8|<0.001
71071855|NCT05633992|141652141|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|29.5|||<|0.001|TWO_SIDED|95.0|17.4|40.6|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 23A||40.6|17.4|<0.001
71071856|NCT05633992|141652141|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|38.3|||<|0.001|TWO_SIDED|95.0|29.3|46.7|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 23B||46.7|29.3|<0.001
71114511|NCT04925076|141737197|SUPERIORITY|||||||0.42|||||||ANOVA|F(1,93)=0.64||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hippocampus activation. Here we report the results of the analysis of the main effect of sex.||||.42
71114512|NCT04925076|141737198|SUPERIORITY|||||||0.44|||||||ANOVA|F(1,93)=0.62||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.44
71114513|NCT04925076|141737198|SUPERIORITY|||||||0.27|||||||ANOVA|F(1,93)=1.23||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the condition X sex interaction.||||.27
71071857|NCT05633992|141652141|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|27.1|||<|0.001|TWO_SIDED|95.0|18.3|35.6|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 24F||35.6|18.3|<0.001
71114514|NCT04925076|141737198|SUPERIORITY|||||||0.06|||||||ANOVA|F(1,93)=3.66||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the condition X family history interaction.||||.06
71114515|NCT04925076|141737198|SUPERIORITY|||||||0.73|||||||ANOVA|F(1,93)=0.13||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the family history X sex interaction.||||.73
71114516|NCT04925076|141737198|SUPERIORITY|||||||0.047|||||||ANOVA|F(1,93)=4.04||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the main effect of condition.||||.047
71114517|NCT04925076|141737198|SUPERIORITY|||||||0.97|||||||ANOVA|F(1,93)=0.001||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the main effect of family history.||||.97
70939776|NCT03320941|141380033|OTHER|Dose Finding|Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.4917||0.833|TWO_SIDED|95.0|-0.884|1.092|||ANCOVA|||Dysglycemic||1.092|-0.884|0.833
70939777|NCT03320941|141380033|OTHER|Dose Finding|Mean Difference (Final Values)|0.605|STANDARD_ERROR_OF_MEAN|2.073||0.771|TWO_SIDED|95.0|-3.541|4.752|||ANCOVA|||T2DM||4.752|-3.541|0.771
71071858|NCT05633992|141652141|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|57.3|||<|0.001|TWO_SIDED|95.0|49.3|64.4|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 31||64.4|49.3|<0.001
71114518|NCT04925076|141737198|SUPERIORITY|||||||0.82|||||||ANOVA|F(1,93)=0.05||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the main effect of sex.||||.82
70939778|NCT03320941|141380033|OTHER|Dose Finding|Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|2.1453||0.991|TWO_SIDED|95.0|-4.315|4.267|||ANCOVA|||T2DM||4.267|-4.315|0.991
70939779|NCT03320941|141380033|OTHER|Dose Finding|Mean Difference (Final Values)|-2.166|STANDARD_ERROR_OF_MEAN|1.9486||0.271|TWO_SIDED|95.0|-6.064|1.732|||ANCOVA|||T2DM||1.732|-6.064|0.271
71071859|NCT05633992|141652141|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|47.0|||<|0.001|TWO_SIDED|95.0|39.5|54.1|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 35B||54.1|39.5|<0.001
71078651|NCT06010732|141665264|SUPERIORITY||Mean Difference (Final Values)|27.2|||<|0.001|TWO_SIDED|95.0|21.7|32.7||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Positive Control-Placebo|Based on previous studies we estimate the standard deviation of the differences between treatments in the crossover model to be 20 for % SMH recovery. With a sample size of 58 subjects completing the study, the study had 80% power to detect a difference between any two treatments of 7.5 for % SMH recovery, assuming two-sided tests each conducted at a 5% significance level.||32.7|21.7|<0.001
71078652|NCT06010732|141665265|SUPERIORITY||Ratio of Means|1.11||||0.23|TWO_SIDED|95.0|0.93|1.32||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Positive Control|analyzed as log(EFU)||1.32|0.93|0.230
70853007|NCT00955201|141194681|SUPERIORITY|||||||0.63|||||||ANOVA|||Comparison across groups at baseline||||0.63
70853008|NCT00955201|141194681|SUPERIORITY|||||||0.31|||||||ANOVA|||Comparison across groups at 12-wk||||0.31
70853009|NCT00955201|141194681|SUPERIORITY|||||||0.28|||||||ANOVA|||Comparison across groups at 24-wk||||0.28
70853010|NCT00955201|141194682|SUPERIORITY|||||||0.53||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.53
70853011|NCT00955201|141194682|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||1.00
70853012|NCT00955201|141194682|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||1.00
70853013|NCT00955201|141194682|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.93
70853014|NCT00955201|141194682|SUPERIORITY|||||||0.8|||||||ANOVA|||Comparison across groups at baseline.||||0.80
70853015|NCT00955201|141194682|SUPERIORITY|||||||0.63|||||||ANOVA|||Comparison across groups at 12-wks||||0.63
70853016|NCT00955201|141194682|SUPERIORITY|||||||0.31|||||||ANOVA|||Comparison across groups at 24-wk||||0.31
70853017|NCT00955201|141194683|SUPERIORITY|||||||0.39||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.39
70853018|NCT00955201|141194683|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||1.00
70853019|NCT00955201|141194683|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||1.00
70853020|NCT00955201|141194683|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.98
70853021|NCT00955201|141194683|SUPERIORITY|||||||0.7|||||||ANOVA|||Comparison across groups at baseline||||0.70
70853022|NCT00955201|141194683|SUPERIORITY|||||||0.45|||||||ANOVA|||Comparison across groups at 12-wks||||0.45
70853023|NCT00955201|141194683|SUPERIORITY|||||||0.22|||||||ANOVA|||Comparison across groups at 24-wks||||0.22
70853024|NCT00955201|141194684|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.98
70853025|NCT00955201|141194684|SUPERIORITY|||||||0.9||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.90
70853026|NCT00955201|141194684|SUPERIORITY|||||||0.97||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.97
70853027|NCT00955201|141194684|SUPERIORITY|||||||0.78||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.78
70853028|NCT00955201|141194684|SUPERIORITY|||||||0.63|||||||ANOVA|||Comparison across groups at baseline||||0.63
70853029|NCT00955201|141194684|SUPERIORITY|||||||0.97|||||||ANOVA|||Comparison across groups at 12-wk||||0.97
70853030|NCT00955201|141194684|SUPERIORITY|||||||0.99|||||||ANOVA|||Comparison across groups at 24-wks||||0.99
70853031|NCT00955201|141194685|SUPERIORITY|||||||0.94||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.94
70853032|NCT00955201|141194685|SUPERIORITY|||||||0.69||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.69
70853033|NCT00955201|141194685|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.98
70853034|NCT00955201|141194685|SUPERIORITY|||||||0.97||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.97
70853035|NCT00955201|141194685|SUPERIORITY|||||||0.45|||||||ANOVA|||Comparison across groups at baseline||||0.45
70853036|NCT00955201|141194685|SUPERIORITY|||||||0.91|||||||ANOVA|||Comparison across groups at 12-wks||||0.91
70853037|NCT00955201|141194685|SUPERIORITY|||||||0.51|||||||ANOVA|||Comparison across groups at 24-wks||||0.51
70853038|NCT00955201|141194686|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.99
70853039|NCT00955201|141194686|SUPERIORITY|||||||0.72||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.72
70853040|NCT00955201|141194686|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.99
70853041|NCT00955201|141194686|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.99
70853042|NCT00955201|141194686|SUPERIORITY|||||||0.85|||||||ANOVA|||Comparison across groups at baseline||||0.85
70853043|NCT00955201|141194686|SUPERIORITY|||||||0.98|||||||ANOVA|||Comparison across groups at 12-wks||||0.98
70853044|NCT00955201|141194686|SUPERIORITY|||||||0.68|||||||ANOVA|||Comparison across groups at 24-wks||||0.68
70853045|NCT00955201|141194687|SUPERIORITY|||||||0.91||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.91
70853046|NCT00955201|141194687|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.99
71071860|NCT03634033|141652148|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) on adoption and sustainability using an evidence-based intervention (CAPABLE).|Mean Difference (Final Values)|10.89|STANDARD_DEVIATION|18.17||0.22|TWO_SIDED|95.0|-7.27|29.05||A priori threshold for statistical significance was .05|t-test, 2 sided|16 degrees of freedom for the t-test comparing two independent groups, n=9 each.||Given 18 sites (9 in each arm) available in Michigan, in the comparison of site-level outcome of adoption and sustainability, the detectable effect size with power of 0.80 in two-sided tests at .05 level of significance was d=1.41.||29.05|-7.27|0.22
71071861|NCT03634033|141652149|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) on beneficiaries ADLs at exit using an evidence-based intervention (CAPABLE).|Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.23||0.73|TWO_SIDED|95.0|-0.16|0.73||A priori threshold for statistical significance was .05; no adjustments for multiple comparisons|Mixed Models Analysis|F-test was used built into mixed models that adjusted for clustering via a random effect of site.|IF minus IF+EF|Adjusted means at month 9 were calculated adjusting for baseline value of the outcome and nesting of participants within sites.||0.73|-0.16|0.73
71071862|NCT03634033|141652150|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) needed on beneficiaries IADLs using an evidence-based intervention (CAPABLE).|Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.15|TWO_SIDED|95.0|-0.11|0.72||Threshold for statistical significance was .05 with no adjustments for multiple comparisons.|Mixed Models Analysis|F-test was used built into mixed models that adjusted for clustering.|IF minus IF+EF|Post-intervention means were compared adjusting for baseline values and nesting of participants within sites.||0.72|-0.11|0.15
71071863|NCT03634033|141652151|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) needed on beneficiaries pain at exit using an evidence-based intervention (CAPABLE).|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.16||0.61|TWO_SIDED|95.0|-0.23|0.39||Threshold for statistical significance was.05; no adjustments for multiple comparisons|Mixed Models Analysis|F-test was used built into mixed models that adjusted for clustering.|IF minus IF+EF|||0.39|-0.23|0.61
71071864|NCT03634033|141652152|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) needed on beneficiaries depression (baseline to exit) using an evidence-based intervention (CAPABLE).|LS Means|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.04|TWO_SIDED|95.0|0.01|0.24|||F-test|F-test was used (related to the t-test arithmetically), built into mixed models that adjusted for clustering.||||0.24|0.01|0.04
71071865|NCT03634033|141652153|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) on beneficiaries fall rates at exit after an evidence-based intervention (CAPABLE).|Odds Ratio (OR)|1.16|STANDARD_ERROR_OF_MEAN|0.01||0.18|TWO_SIDED|95.0|0.93|1.45|||Mixed Models Analysis|||||1.45|0.93|0.18
71071866|NCT03634033|141652153|SUPERIORITY||Odds Ratio (OR)|1.16||||0.18|TWO_SIDED|95.0|0.93|1.45||Threshold for statistical significance was .05; no adjustment for multiple comparisons.|Mixed Models Analysis||Odds ratio for IF versus IF+EF|Occurrence of falls was analyzed with adjustment for baseline and nesting of participants within sites.||1.45|0.93|.18
71071867|NCT03634033|141652154|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) on beneficiaries ED Visits at exit after an evidence-based intervention (CAPABLE).|Odds Ratio (OR)|0.98|STANDARD_ERROR_OF_MEAN|0.01||0.86|TWO_SIDED|95.0|0.79|1.22||Threshold for statistical significance was .05 with no adjustments for multiple comparisons.|Mixed Models Analysis|Adjustment for baseline and nesting of participants within sites.||||1.22|0.79|0.86
71071868|NCT03634033|141652155|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) needed on beneficiaries hospitalizations (baseline to exit) using an evidence-based intervention (CAPABLE).|Odds Ratio (OR)|1.01|STANDARD_ERROR_OF_MEAN|1.01||0.95|TWO_SIDED|95.0|0.72|1.42|||F-test|F-test was used (related to the t-test arithmetically), built into mixed models that adjusted for clustering.||||1.42|0.72|0.95
71071869|NCT03634033|141652156|SUPERIORITY|Examination of clinician attitude on facilitation (IF vs IF+EF) at exit when using an evidence-based intervention (CAPABLE).|Mean Difference (Final Values)|5.11|STANDARD_ERROR_OF_MEAN|2.55||0.05|TWO_SIDED|95.0|0.09|10.14|||Mixed Models Analysis|||Mixed modeling was used to account for nesting of clinicians within sites.||10.14|0.09|0.05
71071870|NCT03634033|141652157|OTHER|Examination of clinician self-efficacy on facilitation (IF vs IF+EF) (baseline to exit) when using an evidence-based intervention (CAPABLE).|Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.36||0.54|TWO_SIDED|95.0|-0.51|0.97||Threshold for statistical significance was .05 with no adjustments for multiple testing.|Mixed Models Analysis|Nesting of clinicians within site was adjusted for as a random effect.||||0.97|-0.51|0.54
71071871|NCT03634033|141652160|SUPERIORITY|Pre-/post-intervention comparison.|Mean Difference (Net)|-2.69|STANDARD_ERROR_OF_MEAN|1.63|<|0.01|TWO_SIDED|95.0|-3.96|-1.42|||t-test, 2 sided||Pre minus post|Pain||-1.42|-3.96|<.01
71071872|NCT03634033|141652160|SUPERIORITY||Mean Difference (Net)|1.05|STANDARD_ERROR_OF_MEAN|1.9||0.58|TWO_SIDED|95.0|-2.8|4.91||Threshold for statistical significance was .05 with no adjustments for multiple comparisons.|t-test, 2 sided|||ADL||4.91|-2.80|.58
71071873|NCT03634033|141652160|SUPERIORITY||Mean Difference (Net)|1.05|STANDARD_ERROR_OF_MEAN|1.29||0.44|TWO_SIDED|95.0|-2.8|4.91||Threshold for statistical significance was .05 with no adjustments for multiple comparisons.|t-test, 2 sided|||IADL||4.91|-2.80|.44
71071874|NCT03634033|141652160|SUPERIORITY||Mean Difference (Net)|1.46|STANDARD_ERROR_OF_MEAN|1.63||0.38|TWO_SIDED|95.0|-1.85|4.77||Threshold for statistical significance was .05 with no adjustments for multiple comparisons.|t-test, 2 sided||Pre minus post|Depression||4.77|-1.85|.38
71071875|NCT03634033|141652161|SUPERIORITY|Self-efficacy|Mean Difference (Net)|-0.81|STANDARD_DEVIATION|0.11|<|0.01|TWO_SIDED|95.0|-1.02|-0.6||Threshold for statistical significance was .05 with no adjustments for multiple comparisons.|t-test, 2 sided||Pre minus post|Self-efficacy change baseline (month-0) to exit (month-4).||-0.60|-1.02|<0.01
71071876|NCT03634033|141652162|OTHER|Score on scale.|Mean|8.09|STANDARD_DEVIATION|1.6|<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<.01
71071877|NCT03634033|141652162|OTHER||Mean|7.55|STANDARD_DEVIATION|2.06|<|0.01|TWO_SIDED||||||t-test, 2 sided|||Satisfaction with format||||<.01
71071878|NCT03634033|141652162|OTHER||Mean|8.35|STANDARD_DEVIATION|1.5|<|0.01|TWO_SIDED||||||Difference from zero|||Satisfaction with newness of content for caregiver||||<.01
71071879|NCT03634033|141652162|OTHER||Mean|7.85|STANDARD_DEVIATION|1.92|<|0.01|TWO_SIDED||||||Difference from zero|||Satisfaction with newness of content for clinician||||<.01
71071880|NCT03634033|141652162|OTHER||Mean|7.85|STANDARD_DEVIATION|1.92|<|0.01|TWO_SIDED||||||Difference from zero|||Intent to use new information||||<.01
71114519|NCT04925076|141737199|SUPERIORITY|||||||0.45|||||||ANOVA|F(1,93)=0.57||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||0.45
70939780|NCT03320941|141380033|OTHER|Dose Finding|Mean Difference (Final Values)|-0.792|STANDARD_ERROR_OF_MEAN|1.8889||0.676|TWO_SIDED|95.0|-4.57|2.986|||ANCOVA|||T2DM||2.986|-4.570|0.676
70939781|NCT03320941|141380034|OTHER|Dose Finding|Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|4.7535||0.968|TWO_SIDED|95.0|-9.603|9.222|||ANCOVA|||Overall Study||9.222|-9.603|0.968
70939782|NCT03320941|141380034|OTHER|Dose Finding|Mean Difference (Final Values)|-1.883|STANDARD_ERROR_OF_MEAN|4.7545||0.693|TWO_SIDED|95.0|-11.297|7.531|||ANCOVA|||Overall Study||7.531|-11.297|0.693
70939783|NCT03320941|141380034|OTHER|Dose Finding|Mean Difference (Final Values)|-5.236|STANDARD_ERROR_OF_MEAN|4.2623||0.222|TWO_SIDED|95.0|-13.676|3.203|||ANCOVA|||Overall Study||3.203|-13.676|0.222
71071881|NCT06366087|141652163|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.7|||||TWO_SIDED|90.0|0.67|0.724|||Mixed Models Analysis||Bioequivalence will be considered met if the 90% CI of the ratio for AUCinf lies within 80.00 to 125.00%.|||0.724|0.670|
71114520|NCT04925076|141737199|SUPERIORITY|||||||0.59|||||||ANOVA|F(1,93)=0.29||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the condition X sex interaction.||||.59
71114521|NCT04925076|141737199|SUPERIORITY|||||||0.07|||||||ANOVA|F(1,93)=3.41||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the condition X family history interaction.||||.07
71114522|NCT04925076|141737199|SUPERIORITY|||||||0.61|||||||ANOVA|F(1,93)=0.26||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the family history X sex interaction.||||.61
71114523|NCT04925076|141737199|SUPERIORITY|||||||0.82|||||||ANOVA|F(1,93)=0.05||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the main effect of condition.||||.82
71114524|NCT04925076|141737199|SUPERIORITY|||||||0.63|||||||ANOVA|F(1,93)=0.23||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the main effect of family history.||||.63
70853047|NCT00955201|141194687|SUPERIORITY|||||||0.94||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.94
71071882|NCT06366087|141652164|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.67|||||TWO_SIDED|90.0|0.64|0.697|||Mixed Models Analysis||Bioequivalence will be considered met if the 90% CI of the ratio for AUCt lies within 80.00 to 125.00%.|||0.697|0.640|
70939784|NCT03320941|141380034|OTHER|Dose Finding|Mean Difference (Final Values)|-7.403|STANDARD_ERROR_OF_MEAN|4.1637||0.078|TWO_SIDED|95.0|-15.648|0.841|||ANCOVA|||Overall Study||0.841|-15.648|0.078
70939785|NCT03320941|141380034|OTHER|Dose Finding|Mean Difference (Final Values)|-1.142|STANDARD_ERROR_OF_MEAN|6.0033||0.85|TWO_SIDED|95.0|-13.194|10.91|||ANCOVA|||Dysglycemic||10.910|-13.194|0.850
70939786|NCT03320941|141380034|OTHER|Dose Finding|Mean Difference (Final Values)|-6.048|STANDARD_ERROR_OF_MEAN|5.7919||0.301|TWO_SIDED|95.0|-17.676|5.58|||ANCOVA|||Dysglycemic||5.580|-17.676|0.301
71114525|NCT04925076|141737199|SUPERIORITY|||||||0.55|||||||ANOVA|F(1,93)=0.36||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the main effect of sex.||||.55
71114526|NCT04925076|141737200|SUPERIORITY|||||||0.57|||||||ANOVA|F(1,93)=0.32||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.57
71114527|NCT04925076|141737200|SUPERIORITY|||||||0.14|||||||ANOVA|F(1,93)=2.17||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the condition X sex interaction.||||.14
71114528|NCT04925076|141737200|SUPERIORITY|||||||0.69|||||||ANOVA|F(1,93)=0.32||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the condition X family history interaction.||||.69
70853048|NCT00955201|141194687|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.93
70853049|NCT00955201|141194687|SUPERIORITY|||||||0.38|||||||ANOVA|||Comparison across groups at baseline||||0.38
70939787|NCT03320941|141380034|OTHER|Dose Finding|Mean Difference (Final Values)|-5.587|STANDARD_ERROR_OF_MEAN|5.2598||0.293|TWO_SIDED|95.0|-16.147|4.972|||ANCOVA|||Dysglycemic||4.972|-16.147|0.293
70939788|NCT03320941|141380034|OTHER|Dose Finding|Mean Difference (Final Values)|-6.943|STANDARD_ERROR_OF_MEAN|5.2191||0.189|TWO_SIDED|95.0|-17.421|3.535|||ANCOVA|||Dysglycemic||3.535|-17.421|0.189
70939789|NCT03320941|141380034|OTHER|Dose Finding|Mean Difference (Final Values)|0.676|STANDARD_ERROR_OF_MEAN|7.2441||0.926|TWO_SIDED|95.0|-13.8|15.152|||ANCOVA|||T2DM||15.152|-13.800|0.926
70939790|NCT03320941|141380034|OTHER|Dose Finding|Mean Difference (Final Values)|1.202|STANDARD_ERROR_OF_MEAN|7.5086||0.873|TWO_SIDED|95.0|-13.802|16.207|||ANCOVA|||T2DM||16.207|-13.802|0.873
70939791|NCT03320941|141380034|OTHER|Dose Finding|Mean Difference (Final Values)|-5.779|STANDARD_ERROR_OF_MEAN|6.6977||0.391|TWO_SIDED|95.0|-19.164|7.605|||ANCOVA|||T2DM||7.605|-19.164|0.391
70939792|NCT03320941|141380034|OTHER|Dose Finding|Mean Difference (Final Values)|-7.591|STANDARD_ERROR_OF_MEAN|6.3822||0.239|TWO_SIDED|95.0|-20.345|5.163|||ANCOVA|||T2DM||5.163|-20.345|0.239
70939793|NCT03320941|141380035|OTHER|Dose Finding|Mean Difference (Final Values)|-3.086|STANDARD_ERROR_OF_MEAN|2.8326||0.278|TWO_SIDED|95.0|-8.696|2.525|||ANCOVA|||Overall Study||2.525|-8.696|0.278
71071883|NCT06366087|141652165|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.11|||||TWO_SIDED|90.0|0.088|0.136|||Mixed Models Analysis|||||0.136|0.088|
71071884|NCT06366087|141652166|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.15|||||TWO_SIDED|90.0|0.12|0.189|||Mixed Models Analysis|||||0.189|0.120|
71071885|NCT06366087|141652167|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.26|||||TWO_SIDED|90.0|0.217|0.309|||Mixed Models Analysis|||||0.309|0.217|
71071886|NCT06366087|141652168|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.36|||||TWO_SIDED|90.0|0.318|0.416|||Mixed Models Analysis|||||0.416|0.318|
71071887|NCT06366087|141652169|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.44|||||TWO_SIDED|90.0|0.396|0.492|||Mixed Models Analysis|||||0.492|0.396|
71071888|NCT06366087|141652170|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.57|||||TWO_SIDED|90.0|0.532|0.608|||Mixed Models Analysis|||||0.608|0.532|
71071889|NCT06366087|141652171|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.57|||||TWO_SIDED|90.0|0.524|0.62|||Mixed Models Analysis|||||0.620|0.524|
71071890|NCT04338269|141652202|OTHER|Stratified Cox Proportional Hazards Model|Hazard Ratio (HR)|1.03||||0.7844|TWO_SIDED|95.0|0.83|1.28|||Log Rank|Stratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.28|0.83|0.7844
71071891|NCT04338269|141652202|OTHER||Hazard Ratio (HR)|1.04||||0.7195|TWO_SIDED|95.0|0.84|1.29|||Log Rank|Unstratified|Hazard ratios were estimated by Cox regression.|Cox Proportional Hazards Model||1.29|0.84|0.7195
71071892|NCT04338269|141652203|OTHER|Stratified Cox Proportional Hazards Model|Hazard Ratio (HR)|0.94||||0.6902|TWO_SIDED|95.0|0.7|1.27|||Log Rank|Stratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.27|0.70|0.6902
71071893|NCT04338269|141652203|OTHER|Cox Proportional Hazards Model|Hazard Ratio (HR)|0.96||||0.7853||95.0|0.71|1.27|||Log Rank|Unstratified|Hazard ratios were estimated by Cox regression.|||1.27|0.71|0.7853
71071894|NCT04338269|141652204|OTHER|Stratified Cox Proportional Hazards Model|Hazard Ratio (HR)|1.03||||0.8037|TWO_SIDED|95.0|0.83|1.27|||Log Rank|Stratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.27|0.83|0.8037
71071895|NCT04338269|141652204|OTHER|Cox Proportional Hazards Model|Hazard Ratio (HR)|1.03||||0.7894|TWO_SIDED|95.0|0.83|1.27|||Log Rank|Unstratified|Hazard ratios were estimated by Cox regression.|||1.27|0.83|0.7894
70853050|NCT00955201|141194687|SUPERIORITY|||||||0.51|||||||ANOVA|||Comparison across groups at 12-wks||||0.51
70939794|NCT03320941|141380035|OTHER|Dose Finding|Mean Difference (Final Values)|-0.977|STANDARD_ERROR_OF_MEAN|2.859||0.733|TWO_SIDED|95.0|-6.639|4.686|||ANCOVA|||Overall Study||4.686|-6.639|0.733
71071896|NCT04338269|141652205|OTHER|Difference in Overall Response Rates|Odds Ratio (OR)|-3.68||||0.4306|TWO_SIDED|95.0|-12.45|5.1|||Cochran-Mantel-Haenszel||Odds ratio 95% CI was constructed using the Wald method. If at least one stratum has \<10 events at the time of analysis, the stratification factor containing the level with the smallest number of patients will be removed from the stratified analysis|||5.10|-12.45|0.4306
71071897|NCT04338269|141652206|OTHER|Difference in Overall Response Rates|Odds Ratio (OR)|1.0||||0.9893|TWO_SIDED|95.0|0.7|1.43|||Cochran-Mantel-Haenszel||Odds ratio 95% CI was constructed using the Wald method. If at least one stratum has \<10 events at the time of analysis, the stratification factor containing the level with the smallest number of patients will be removed from the stratified analysis|||1.43|0.70|0.9893
70853051|NCT00955201|141194687|SUPERIORITY|||||||0.94|||||||ANOVA|||Comparison across groups at 24-wks||||0.94
70853052|NCT00955201|141194688|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.99
70853053|NCT00955201|141194688|SUPERIORITY|||||||0.97||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.97
70939795|NCT03320941|141380035|OTHER|Dose Finding|Mean Difference (Final Values)|-4.507|STANDARD_ERROR_OF_MEAN|2.5118||0.075|TWO_SIDED|95.0|-9.482|0.468|||ANCOVA|||Overall Study||0.468|-9.482|0.075
70939796|NCT03320941|141380035|OTHER|Dose Finding|Mean Difference (Final Values)|-2.268|STANDARD_ERROR_OF_MEAN|2.4659||0.36|TWO_SIDED|95.0|-7.152|2.616|||ANCOVA|||Overall Study||2.616|-7.152|0.360
70939797|NCT03320941|141380035|OTHER|Dose Finding|Mean Difference (Final Values)|-3.147|STANDARD_ERROR_OF_MEAN|4.1699||0.416|TWO_SIDED|95.0|-11.792|4.959|||ANCOVA|||Dysglycemic||4.959|-11.792|0.416
71114529|NCT04925076|141737200|SUPERIORITY|||||||0.34|||||||ANOVA|F(1,93)=0.92||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the family history X sex interaction.||||.34
71114530|NCT04925076|141737200|SUPERIORITY|||||||0.29|||||||ANOVA|F(1,93)=1.16||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the main effect of condition.||||0.29
71114531|NCT04925076|141737200|SUPERIORITY|||||||0.95|||||||ANOVA|F(1,93)=0.004||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the main effect of family history.||||.95
71114532|NCT04925076|141737200|SUPERIORITY|||||||0.11|||||||ANOVA|F(1,93)=2.65||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the main effect of sex.||||.11
71114533|NCT01460875|141737236|NON_INFERIORITY|The method to be developed will allow us to declare that a response at a lower dose is not inferior to that at the standard dose for a particular patient, using a patient specific inferiority test.||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||.22
71114534|NCT02150057|141737259|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71114535|NCT00394251|141737270|SUPERIORITY_OR_OTHER_LEGACY|||||||0.641|||||||Fisher Exact|||Comparison of percentage of participants with at least one taxane-emergent toxicity||||0.641
71114536|NCT00394251|141737276|SUPERIORITY_OR_OTHER_LEGACY|||||||0.323||95.0|||||Fisher Exact|||Comparison of percentage of participants with at least one taxane-emergent toxicity||||0.323
71114537|NCT05791565|141737277|OTHER||Ratio of Geometric LS Means|1.1609|||||TWO_SIDED|90.0|1.0221|1.3185|||||Ratio of the Geometric LS means = Geometric LS mean of the Salbutamol HFA-152a MDI to the Geometric LS mean of the Salbutamol HFA-134a MDI.|||1.3185|1.0221|
71114538|NCT05791565|141737278|OTHER||Ratio of the Geometric LS Means|1.4081|||||TWO_SIDED|90.0|1.2998|1.5255|||||Ratio of the Geometric LS means = Geometric LS mean of the Salbutamol HFA-152a MDI to the Geometric LS mean of the Salbutamol HFA-134a MDI.|||1.5255|1.2998|
70853054|NCT00955201|141194688|SUPERIORITY|||||||0.96||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.96
71114539|NCT05791565|141737279|OTHER||Ratio of the Geometric LS Means|1.3885|||||TWO_SIDED|90.0|1.2793|1.507|||||Ratio of the Geometric LS means = Geometric LS mean of the Salbutamol HFA-152a MDI to the Geometric LS mean of the Salbutamol HFA-134a MDI.|||1.5070|1.2793|
71114540|NCT05791565|141737280|OTHER||Ratio of the Geometric LS Means|1.3141|||||TWO_SIDED|90.0|1.1816|1.4614|||||Ratio of the Geometric LS means = Geometric LS mean of the Salbutamol HFA-152a MDI to the Geometric LS mean of the Salbutamol HFA-134a MDI.|||1.4614|1.1816|
71114541|NCT02388165|141737308|SUPERIORITY||Vaccine Efficacy (VE)|0.0|||||TWO_SIDED|95.0|-126.3|55.81|||||VE was calculated as 1-(P/\[1-P\]\*100), where P is the number of SA4Ag cases divided by the total number of cases. The confidence interval (CI) was calculated using the Clopper-Pearson method.|||55.81|-126.30|
71114542|NCT02388165|141737309|SUPERIORITY||Difference in percentage of participants|8.3|||<|0.001|TWO_SIDED|95.0|6.9|9.8|||Miettinen and Nurminen|||Redness: Any||9.8|6.9|<0.001
71114543|NCT02388165|141737309|SUPERIORITY||Difference in percentage of participants|4.4|||||TWO_SIDED|95.0|3.3|5.6||||||Redness: Mild||5.6|3.3|
71114544|NCT02388165|141737309|SUPERIORITY||Difference in percentage of participants|3.0|||||TWO_SIDED|95.0|2.3|4.0||||||Redness: Moderate||4.0|2.3|
71114545|NCT02388165|141737309|SUPERIORITY||Difference in percentage of participants|0.8|||||TWO_SIDED|95.0|0.5|1.4||||||Redness: Severe||1.4|0.5|
71114546|NCT02388165|141737309|SUPERIORITY||Difference in percentage of participants|7.0|||<|0.001|TWO_SIDED|95.0|5.7|8.4|||Miettinen and Nurminen|||Swelling: Any||8.4|5.7|<0.001
71114547|NCT02388165|141737309|SUPERIORITY||Difference in percentage of participants|3.9|||||TWO_SIDED|95.0|2.8|5.0||||||Swelling: Mild||5.0|2.8|
71114548|NCT02388165|141737309|SUPERIORITY||Difference in percentage of participants|2.4|||||TWO_SIDED|95.0|1.7|3.3||||||Swelling: Moderate||3.3|1.7|
71114549|NCT02388165|141737309|SUPERIORITY||Difference in percentage of participants|0.7|||||TWO_SIDED|95.0|0.4|1.2||||||Swelling: Severe||1.2|0.4|
71114550|NCT02388165|141737309|SUPERIORITY||Difference in percentage of participants|15.7|||<|0.001|TWO_SIDED|95.0|13.3|18.1|||Miettinen and Nurminen|||Pain at the injection site: Any||18.1|13.3|<0.001
71114551|NCT02388165|141737309|SUPERIORITY||Difference in percentage of participants|12.2|||||TWO_SIDED|95.0|10.0|14.5||||||Pain at the injection site: Mild||14.5|10.0|
70853055|NCT00955201|141194688|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||1.00
70853056|NCT00955201|141194688|SUPERIORITY|||||||0.16|||||||ANOVA|||Comparison across groups at baseline.||||0.16
70853057|NCT00955201|141194688|SUPERIORITY|||||||0.37|||||||ANOVA|||Comparison across groups at 12-wks||||0.37
70853058|NCT00955201|141194688|SUPERIORITY|||||||0.75|||||||ANOVA|||Comparison across groups at 24-wks||||0.75
70853059|NCT00955201|141194689|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||1.00
71114552|NCT02388165|141737309|SUPERIORITY||Difference in percentage of participants|3.0|||||TWO_SIDED|95.0|1.9|4.2||||||Pain at the injection site: Moderate||4.2|1.9|
71114553|NCT02388165|141737309|SUPERIORITY||Difference in percentage of participants|0.5|||||TWO_SIDED|95.0|0.1|1.0||||||Pain at the injection site: Severe||1.0|0.1|
71114554|NCT02388165|141737310|SUPERIORITY||Difference in percentage of participants|0.6||||0.146|TWO_SIDED|95.0|-0.2|1.6|||Miettinen and Nurminen|||Fever: Any||1.6|-0.2|0.146
71114555|NCT02388165|141737310|SUPERIORITY||Difference in percentage of participants|0.4|||||TWO_SIDED|95.0|-0.3|1.2||||||Fever: 38.0 degree C to 38.4 degree C||1.2|-0.3|
71114556|NCT02388165|141737310|SUPERIORITY||Difference in percentage of participants|0.1|||||TWO_SIDED|95.0|-0.4|0.6||||||Fever: 38.5 degree C to 38.9 degree C||0.6|-0.4|
71114557|NCT02388165|141737310|SUPERIORITY||Difference in percentage of participants|0.1|||||TWO_SIDED|95.0|-0.2|0.5||||||Fever: 39.0 degree C to 40.0 degree C||0.5|-0.2|
71114558|NCT02388165|141737310|SUPERIORITY||Difference in percentage of participants|0.1|||||TWO_SIDED|95.0|-0.2|0.3||||||Fever: \>40.0 degree C||0.3|-0.2|
71114559|NCT02388165|141737310|SUPERIORITY||Difference in percentage of participants|2.9||||0.093||95.0|-0.5|6.2|||Miettinen and Nurminen|||Fatigue: Any||6.2|-0.5|0.093
70939798|NCT03320941|141380035|OTHER|Dose Finding|Mean Difference (Final Values)|-1.634|STANDARD_ERROR_OF_MEAN|4.1121||0.693|TWO_SIDED|95.0|-9.893|6.625|||ANCOVA|||Dysglycemic||6.625|-9.893|0.693
70939799|NCT03320941|141380035|OTHER|Dose Finding|Mean Difference (Final Values)|-2.906|STANDARD_ERROR_OF_MEAN|3.6351||0.428|TWO_SIDED|95.0|-10.207|4.396|||ANCOVA|||Dysglycemic||4.396|-10.207|0.428
70939800|NCT03320941|141380035|OTHER|Dose Finding|Mean Difference (Final Values)|2.201|STANDARD_ERROR_OF_MEAN|3.6414||0.548|TWO_SIDED|95.0|-5.113|9.515|||ANCOVA|||Dysglycemic||9.515|-5.113|0.548
70939801|NCT03320941|141380035|OTHER|Dose Finding|Mean Difference (Final Values)|-2.636|STANDARD_ERROR_OF_MEAN|3.8828||0.5|TWO_SIDED|95.0|-10.4|5.128|||ANCOVA|||T2DM||5.128|-10.400|0.500
70939802|NCT03320941|141380035|OTHER|Dose Finding|Mean Difference (Final Values)|-0.826|STANDARD_ERROR_OF_MEAN|3.9906||0.837|TWO_SIDED|95.0|-8.805|7.154|||ANCOVA|||T2DM||7.154|-8.805|0.837
71071898|NCT04338269|141652207|OTHER|Difference between Duration of Response (DOR) rates|Hazard Ratio (HR)|0.7||||0.0816|TWO_SIDED|95.0|0.47|1.05|||Log Rank|Stratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.05|0.47|0.0816
71071899|NCT04338269|141652207|OTHER|Difference between Duration of Response (DOR) rates|Hazard Ratio (HR)|0.72||||0.1099||95.0|0.49|1.08|||Log Rank|Unstratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.08|0.49|0.1099
71114560|NCT02388165|141737310|SUPERIORITY||Difference in percentage of participants|1.4|||||TWO_SIDED|95.0|-0.9|3.7||||||Fatigue: Mild||3.7|-0.9|
71114561|NCT02388165|141737310|SUPERIORITY||Difference in percentage of participants|1.3|||||TWO_SIDED|95.0|-1.6|4.2||||||Fatigue: Moderate||4.2|-1.6|
70939803|NCT03320941|141380035|OTHER|Dose Finding|Mean Difference (Final Values)|-5.594|STANDARD_ERROR_OF_MEAN|3.4818||0.113|TWO_SIDED|95.0|-12.556|1.368|||ANCOVA|||T2DM||1.368|-12.556|0.113
70939804|NCT03320941|141380035|OTHER|Dose Finding|Mean Difference (Final Values)|-5.66|STANDARD_ERROR_OF_MEAN|3.3512||0.096|TWO_SIDED|95.0|-12.361|1.041|||ANCOVA|||T2DM||1.041|-12.361|0.096
70939805|NCT03614923|141380037|SUPERIORITY|Statistical significance for the co-primary efficacy endpoints would be declared if both p-values for the tests of the individual hypotheses were \< 0.05.|Least Squares (LS) Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.319||0.2364|TWO_SIDED|95.0|-1.01|0.25||Testing was conducted in a hierarchical manner such that the comparison of etokimab Q4W versus placebo was conducted first. If the results of this comparison were statistically significant, the etokimab Q8W treatment arm would be compared to placebo.|General linear MMRM|||A general linear mixed effects model with repeated measures (MMRM) was used including the change from Baseline in NPS as dependent variable; treatment group, stratification factor, time (Weeks 4, 8, 12, and 16), treatment by stratification factor, and treatment by time interaction as fixed effect factors; Baseline NPS as covariate; and subject as random effect.||0.25|-1.01|0.2364
70939806|NCT03614923|141380037|SUPERIORITY|Statistical significance for the co-primary efficacy endpoints was to be declared if both p-values for the tests of the individual hypotheses were \< 0.05.|LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.316||0.2024|TWO_SIDED|95.0|-1.03|0.22||Testing was conducted in a hierarchical manner such that the comparison of etokimab Q4W versus placebo was conducted first. If the results of this comparison were statistically significant, the etokimab Q8W treatment arm would be compared to placebo.|General linear MMRM|||A general linear mixed effects model with repeated measures (MMRM) was used including the change from Baseline in NPS as dependent variable; treatment group, stratification factor, time (Weeks 4, 8, 12, and 16), treatment by stratification factor, and treatment by time interaction as fixed effect factors; Baseline NPS as covariate; and subject as random effect.||0.22|-1.03|0.2024
70939807|NCT03614923|141380038|SUPERIORITY|Statistical significance for the co-primary efficacy endpoints was to be declared if both p-values for the tests of the individual hypotheses were \< 0.05.|LS Mean Difference|-6.64|STANDARD_ERROR_OF_MEAN|4.383||0.133|TWO_SIDED|95.0|-15.34|2.06||Testing was conducted in a hierarchical manner such that the comparison of etokimab Q4W versus placebo was conducted first. If the results of this comparison were statistically significant, the etokimab Q8W treatment arm would be compared to placebo.|General linear MMRM|||A general linear mixed effects model with repeated measures (MMRM) was used including the change from Baseline in SNOT-22 as dependent variable; treatment group, stratification factor, time (Weeks 4, 8, 12, and 16), treatment by stratification factor, and treatment by time interaction as fixed effect factors; Baseline SNOT-22 as covariate; and subject as random effect.||2.06|-15.34|0.1330
71071900|NCT04338269|141652208|OTHER|Difference between Duration of Response (DOR) rates|Hazard Ratio (HR)|1.04||||0.8354|TWO_SIDED|95.0|0.7|1.54|||Log Rank|Stratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.54|0.70|0.8354
71071901|NCT04338269|141652208|OTHER|Difference between Duration of Response (DOR) rates|Hazard Ratio (HR)|1.05||||0.8159|TWO_SIDED|95.0|0.71|1.55|||Log Rank|Unstratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.55|0.71|0.8159
71071902|NCT02715700|141652248|OTHER|Geometric mean ratio (GMR) of Methadone + Doravirine/Methadone Alone|GMR|0.95|||||TWO_SIDED|90.0|0.9|1.01||||||||1.01|0.90|
71071903|NCT02715700|141652249|OTHER|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.95|||||TWO_SIDED|90.0|0.88|1.03||||||||1.03|0.88|
71114562|NCT02388165|141737310|SUPERIORITY||Difference in percentage of participants|0.2|||||TWO_SIDED|95.0|-1.2|1.6||||||Fatigue: Severe||1.6|-1.2|
71114563|NCT02388165|141737310|SUPERIORITY||Difference in percentage of participants|1.2||||0.443|TWO_SIDED|95.0|-1.9|4.4|||Miettinen and Nurminen|||Headache: Any||4.4|-1.9|0.443
71114564|NCT02388165|141737310|SUPERIORITY||Difference in percentage of participants|-0.3|||||TWO_SIDED|95.0|-2.9|2.3||||||Headache: Mild||2.3|-2.9|
71114565|NCT02388165|141737310|SUPERIORITY||Difference in percentage of participants|1.5|||||TWO_SIDED|95.0|-0.7|3.8||||||Headache: Moderate||3.8|-0.7|
71114566|NCT02388165|141737310|SUPERIORITY||Difference in percentage of participants|0.0|||||TWO_SIDED|95.0|-0.8|0.8||||||Headache: Severe||0.8|-0.8|
71071904|NCT02715700|141652250|OTHER|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.98|||||TWO_SIDED|90.0|0.93|1.03||||||||1.03|0.93|
70853060|NCT00955201|141194689|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.99
71071905|NCT02715700|141652252|OTHER|Geometric mean ratio (GMR) of Methadone + Doravirine/Methadone Alone|GMR|0.98|||||TWO_SIDED|90.0|0.9|1.06||||||||1.06|0.90|
71071906|NCT02715700|141652253|OTHER|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.97|||||TWO_SIDED|90.0|0.86|1.1||||||||1.10|0.86|
71071907|NCT02715700|141652254|OTHER|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.97|||||TWO_SIDED|90.0|0.91|1.04||||||||1.04|0.91|
71071908|NCT02715700|141652256|OTHER|Geometric mean ratio (GMR) of Methadone + Doravirine/Methadone Alone|GMR|0.96|||||TWO_SIDED|90.0|0.9|1.03||||||||1.03|0.90|
71071909|NCT02715700|141652257|OTHER|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.96|||||TWO_SIDED|90.0|0.87|1.05||||||||1.05|0.87|
71071910|NCT02715700|141652258|OTHER|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.98|||||TWO_SIDED|90.0|0.92|1.03||||||||1.03|0.92|
71071911|NCT04166591|141652260|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||binomial test|||||||<0.01
70853061|NCT00955201|141194689|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||1.00
70853062|NCT00955201|141194689|SUPERIORITY|||||||0.81||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.81
71071912|NCT04166591|141652260|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||Binomial test|||||||<0.01
71071913|NCT04166591|141652260|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||Binomial test|||||||<0.01
71071914|NCT04166591|141652260|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||Binomial test|||||||<0.01
71071915|NCT04166591|141652261|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||Binomial test|||||||<0.01
71071916|NCT04166591|141652261|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.||||||0.12|||||||Binomial test|||||||0.12
71071917|NCT04166591|141652261|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||Binomial test|||||||<0.01
71071918|NCT04166591|141652261|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||Binomial test|||||||<0.01
71071919|NCT02730377|141652262|SUPERIORITY||||||<|0.0001|||||||Log Rank|||Test for no treatment difference is based on using a generalised log-rank test for interval censored failure time data.||||<.0001
71071920|NCT02111746|141652285|SUPERIORITY|||||||0.934|||||||Wilcoxon (Mann-Whitney)|||||||0.934
71071921|NCT02111746|141652286|SUPERIORITY|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||||||0.036
70853063|NCT00955201|141194689|SUPERIORITY|||||||0.28|||||||ANOVA|||Comparison across groups at baseline||||0.28
70853064|NCT00955201|141194689|SUPERIORITY|||||||0.28|||||||ANOVA|||Comparison across groups at 12-wks||||0.28
70853065|NCT00955201|141194689|SUPERIORITY|||||||0.83|||||||ANOVA|||Comparison across groups at 24-wks||||0.83
70853066|NCT00955201|141194690|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.99
70853067|NCT00955201|141194690|SUPERIORITY|||||||0.97||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.97
70853068|NCT00955201|141194690|SUPERIORITY|||||||0.82||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.82
70853069|NCT00955201|141194690|SUPERIORITY|||||||0.96||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.96
71071922|NCT02111746|141652287|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
71071923|NCT02111746|141652288|SUPERIORITY|||||||0.512|||||||Wilcoxon (Mann-Whitney)|||||||0.512
71071924|NCT02111746|141652289|SUPERIORITY|||||||0.449|||||||Wilcoxon (Mann-Whitney)|||||||0.449
71071925|NCT02111746|141652290|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
71071926|NCT02111746|141652291|SUPERIORITY|||||||0.774|||||||Wilcoxon (Mann-Whitney)|||||||0.774
71071927|NCT02111746|141652292|SUPERIORITY|||||||0.188|||||||Wilcoxon (Mann-Whitney)|||||||0.188
71071928|NCT02111746|141652293|SUPERIORITY|||||||0.202|||||||Wilcoxon (Mann-Whitney)|||||||0.202
71071929|NCT03796442|141652329|NON_INFERIORITY|The study was designed to have 80% power to detect 1-year AVMPG of 12.6±4.3mmHg for the study prosthesis and 11.9±4.3mmHg for the control prosthesis, with a 1-sided type I error of 2.5% and a noninferiority margin of 3mmHg. The noninferiority margin was determined by the values of 15mmHg for AVMPG of clinically significant aortic stenosis and 12mmHg for AVMPG of the control prosthesis.||||||0.0004|||||||t-test, 1 sided|||The null hypothesis was that the AvalusTM was inferior to the CEPME based on the AVMPG at 1-year echocardiographic follow-up, with a non-inferiority margin of 3mmHg. The result for the primary endpoint was presented with 97.5% one-sided confidence interval for mean difference between groups. The non-inferiority test was performed using a t-test which compared mean difference between groups with the non-inferiority margin under the one-sided significance level of 0.025.||||0.0004
71114567|NCT02388165|141737310|SUPERIORITY||Difference in percentage of participants|1.0||||0.462|TWO_SIDED|95.0|-1.6|3.4|||Miettinen and Nurminen|||Diarrhea: Any||3.4|-1.6|0.462
70939808|NCT03614923|141380038|SUPERIORITY|Statistical significance for the co-primary efficacy endpoints was to be declared if both p-values for the tests of the individual hypotheses were \< 0.05.|LS Mean Difference|-2.01|STANDARD_ERROR_OF_MEAN|4.375||0.6464|TWO_SIDED|95.0|-10.7|6.67||Testing was conducted in a hierarchical manner such that the comparison of etokimab Q4W versus placebo was conducted first. If the results of this comparison were statistically significant, the etokimab Q8W treatment arm would be compared to placebo.|General linear MMRM|||A general linear mixed effects model with repeated measures (MMRM) was used including the change from Baseline in SNOT-22 as dependent variable; treatment group, stratification factor, time (Weeks 4, 8, 12, and 16), treatment by stratification factor, and treatment by time interaction as fixed effect factors; Baseline SNOT-22 as covariate; and subject as random effect.||6.67|-10.70|0.6464
70939809|NCT01136733|141380043|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||=|0.0005|TWO_SIDED|95.0|0.24|0.68|||Log Rank||Hazard ratio between treatment groups and corresponding 95% CI was estimated using the stratified Cox regression model (stratified by hemoglobin and corrected serum calcium) with treatment as a factor.|Null hypothesis of no difference in PFS was analyzed using the stratified log-rank test with hemoglobin (less than or equal to 13 g/dL vs greater than 13 g/dL for males; and less than or equal to 11.5 g/dL vs greater than 11.5 g/dL for females) and corrected serum calcium (greater than or equal to 10 mg/dL vs less than 10 mg/dL) as stratification factors. Each null hypothesis was tested at a nominal alpha=0.05.||0.68|0.24|=0.0005
70939810|NCT01136733|141380043|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.0479|TWO_SIDED|95.0|0.38|0.98|||Log Rank|||||0.98|0.38|0.0479
70939811|NCT01136733|141380043|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.1209|TWO_SIDED|95.0|0.39|1.1|||Log Rank|||||1.10|0.39|0.1209
70939812|NCT01136733|141380044|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.514|||=|0.0242|TWO_SIDED|95.0|0.299|0.884|||Log Rank||Hazard ratio between treatment groups and corresponding 95% CI was estimated using the stratified Cox regression model (stratified by hemoglobin and corrected serum calcium) with treatment as a factor.|Planned analyses were performed to test null hypothesis of treatment difference in OS at a nominal significance level of 0.05 (2-sided) using the stratified log-rank test using stratification factors.||0.884|0.299|=0.0242
70939813|NCT01136733|141380044|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.684|||=|0.1181|TWO_SIDED|95.0|0.411|1.138|||Log Rank|||||1.138|0.411|=0.1181
70939814|NCT01136733|141380044|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.751|||=|0.3157|TWO_SIDED|95.0|0.433|1.301|||Log Rank|||||1.301|0.433|=0.3157
71071930|NCT03687372|141652391|SUPERIORITY||Mean Difference (Final Values)|3.22||||0.0003|TWO_SIDED|95.0|1.67|6.22||P-Value test comparing the Patients Cleared of All Baseline Warts in the Active (A-101 45%) and vehicle groups.|Mixed Models Analysis|||A summary of the wart clearance at Visit 10.||6.22|1.67|0.0003
70939815|NCT01136733|141380045|SUPERIORITY_OR_OTHER||Rate ratio|7.2|||<|0.0001|TWO_SIDED|95.0|2.3|22.5||Analysis performed after database lock. P-value was based on the 2-sided Fisher's exact P-value.|Fisher Exact||Rate ratio was based on the normal approximation.|||22.5|2.3|<0.0001
70939816|NCT01136733|141380045|SUPERIORITY_OR_OTHER||Rate ratio|4.5||||0.0067|TWO_SIDED|95.0|1.4|14.7||Analysis performed after database lock. P-value was based on the 2-sided Fisher's exact P-value.|Fisher Exact|||||14.7|1.4|0.0067
70939817|NCT01136733|141380045|SUPERIORITY_OR_OTHER||Rate ratio|1.6|||=|0.1007|TWO_SIDED|95.0|0.9|2.8||Analysis performed after database lock. P-value was based on the 2-sided Fisher's exact P-value.|Fisher Exact|||||2.8|0.9|=0.1007
70939818|NCT01014013|141380066|NON_INFERIORITY_OR_EQUIVALENCE|The primary efficacy endpoint was based on the proportion of patients who had a favorable microbiological response assessment at follow-up 5 to 9 days post-therapy visit. The definition of non-inferiority is that the 95%(two-sided) confidence interval for the difference in response rate between the 2 treatment groups(MK0826 minus control group) contains zero and the lower limit of the CI is not less than -20 percentage points.|the difference between two response rate|-0.8|STANDARD_DEVIATION|10.9||||95.0|-11.7|10.2||||||||10.2|-11.7|
70939819|NCT01014013|141380068|NON_INFERIORITY_OR_EQUIVALENCE|The secondary efficacy endpoint was based on the proportion of patients who had a favorable clinical response assessment at follow-up 5 to 9 days post-therapy visit. The definition of non-inferiority is that the 95%(two-sided) confidence interval for the difference in response rate between the 2 treatment groups(MK0826 minus control group) contains zero and the lower limit of the CI is not less than -20 percentage points.|the difference between two response rate|-1.7|STANDARD_ERROR_OF_MEAN|4.9||||95.0|-6.6|3.2||||||||3.2|-6.6|
70939820|NCT02100189|141380080|SUPERIORITY_OR_OTHER||Sensitivity|13.3|STANDARD_ERROR_OF_MEAN|0.062|||TWO_SIDED|95.0|3.76|30.72|||Sensitivity||Exact Binomial confidence interval.|||30.72|3.76|
70939821|NCT02100189|141380081|SUPERIORITY_OR_OTHER||Specificity|94.7|STANDARD_ERROR_OF_MEAN|0.051|||TWO_SIDED|95.0|73.97|99.87|||Specificity||Exact binomial confidence interval|||99.87|73.97|
71071931|NCT03687372|141652392|SUPERIORITY|P-Value test comparing the Patients Cleared of All Baseline Warts in the Active (A-101 45%) and vehicle groups.|Mean Difference (Final Values)|2.14||||0.0024|TWO_SIDED|95.0|1.3|3.52|||Mixed Models Analysis|||||3.52|1.30|0.0024
71071932|NCT03687372|141652393|SUPERIORITY||Odds Ratio (OR)|14.12|||<|0.0001|TWO_SIDED|95.0|7.5|20.8|||Wilcoxon (Mann-Whitney)|||||20.8|7.5|<0.0001
71071933|NCT03687372|141652394|SUPERIORITY||Odds Ratio (OR)|3.22||||0.0009|TWO_SIDED|95.0|1.55|6.65|||Wilcoxon (Mann-Whitney)|||||6.65|1.55|0.0009
71071934|NCT03687372|141652395|SUPERIORITY||Hazard Ratio (HR)|2.56|||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
71071935|NCT01152359|141652411|SUPERIORITY||Mean Difference (Final Values)|1.1|||<|0.05|TWO_SIDED|95.0|-0.8|2.9|||Mixed Models Analysis|||||2.9|-0.8|<0.05
71071936|NCT01152359|141652412|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.66|TWO_SIDED|95.0|-4.9|3.1|||Mixed Models Analysis|||||3.1|-4.9|0.66
71071937|NCT01152359|141652413|SUPERIORITY||Mean Difference (Net)|-0.8||||0.65|TWO_SIDED|95.0|-4.1|2.6|||Mixed Models Analysis|||||2.6|-4.1|0.65
71071938|NCT01041976|141652445|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71071939|NCT01041976|141652446|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
71071940|NCT00380081|141652447|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
71071941|NCT00380081|141652448|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|Cochran-Mantel-Haenszel|||||||<0.001
71071942|NCT00380081|141652449|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
70853070|NCT00955201|141194690|SUPERIORITY|||||||0.55|||||||ANOVA|||Comparison across groups at baseline.||||0.55
70939822|NCT02213458|141380090|SUPERIORITY||Slope|0.539||||0.04|TWO_SIDED|95.0|0.259|1.337|||Mixed Models Analysis|Controlling for dementia severity (QDRS)||Linear mixed effects model||1.337|.259|0.04
70939823|NCT02213458|141380091|SUPERIORITY||Slope|-0.138||||0.05|TWO_SIDED|95.0|-0.295|-0.02|||Mixed Models Analysis|Linear mixed model controlling for dementia severity (QDRS)||||-.020|-.295|.05
70939824|NCT02213458|141380092|SUPERIORITY||Slope|-1.902||||0.07|TWO_SIDED|95.0|-3.885|-0.08|||Mixed Models Analysis|Linear mixed model controlling for dementia severity (QDRS)||||-0.080|-3.885|0.07
70939825|NCT02213458|141380094|SUPERIORITY||Slope|-1.143||||0.03|TWO_SIDED|95.0|-2.154|-0.132|||Mixed Models Analysis|||||-0.132|-2.154|0.03
70939826|NCT02213458|141380095|SUPERIORITY||Slope|0.635||||0.11|TWO_SIDED|95.0|-0.135|1.405|||Mixed Models Analysis|Controlling for dementia severity (QDRS)||||1.405|-0.135|0.11
71071943|NCT00380081|141652450|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
71071944|NCT00380081|141652451|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
71071945|NCT00380081|141652452|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
71071946|NCT00380081|141652453|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|Cochran-Mantel-Haenszel|||The outcome noted above reflects the all-night sleep quality rating of study subjects who had a scheduled awakening after approximately 4 hours of sleep, were kept awake for 30 minutes and then allowed to return to bed and to sleep. After 4 hours, they were awakened again and disconnected from the PSG apparatus. Morning testing was conducted that included the Sleep Quality questionnaire. Evaluation of the results should reflect the nature of the study and the scheduled sleep disturbance.||||<0.001
70939827|NCT04799587|141380118|SUPERIORITY|Sample size for the study was determined by assuming a baseline rate of 33% of IONV and that there will be a relative decrease of 50% in the group that receives P6 acupressure during CD. A two-sided Fisher's Exact Test, with a significance level of 0.05, group sizes of 98 are needed to achieve 80% power to detect a difference between the group proportions of 0.18. Group sizes were rounded up to 100. Statistical analyses were two-sided, and a P\<0.05 was required to reject the null hypothesis.||||||0.94|||||||Chi-squared|||The incidence of nausea and vomiting and the number of episodes between the P6 acupressure and sham acupressure groups were compared using a chi-square statistic (nominal data) or the Wilcoxon test (continuous data).||||.94
70939828|NCT04799587|141380119|SUPERIORITY|||||||0.95|||||||Chi-squared|||The sample size for the study was determined by assuming a baseline rate of 33% of intraoperative nausea and vomiting and that there will be a relative decrease of 50% in the group that receives P6 acupressure during CD.20 Using a two-sided Fisher's Exact Test, with a significance level of 0.05, group sizes of 98 are needed to achieve 80% power to detect a difference between the group proportions of 0.18. Group sizes were rounded up to 100||||.95
70939829|NCT00515281|141380146|SUPERIORITY|||||||0.017|||||||Chi-squared|||||||0.017
70939830|NCT00515281|141380147|SUPERIORITY|||||||0.288|||||||Chi-squared|||||||0.288
70939831|NCT00515281|141380148|SUPERIORITY|||||||0.009|||||||Chi-squared|||||||0.009
70939832|NCT00515281|141380149|SUPERIORITY|||||||0.97|||||||Chi-squared|||||||0.97
70939833|NCT00515281|141380150|SUPERIORITY|||||||0.72|||||||Chi-squared|||||||0.72
70939834|NCT00515281|141380151|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
70939835|NCT00515281|141380152|SUPERIORITY|||||||0.28|||||||Chi-squared|||||||0.28
70939836|NCT06312566|141380160|EQUIVALENCE|Bioequivalence between the BRV tablet (reference) and BRV dry syrup (test) formulations were concluded if the 92.016% CI limits for Cmax,ss was within the 0.80 to 1.25 range.|Ratio of Dry Syrup/ Tablet|0.9726|||||TWO_SIDED|92.016|0.9257|1.022|||Linear mixed model analysis|||||1.022|0.9257|
71071947|NCT00380081|141652454|SUPERIORITY_OR_OTHER||||||<|0.004||95.0||||Treatment effect|Cochran-Mantel-Haenszel|||||||<0.004
71071948|NCT00380081|141652455|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Treatment effect|Cochran-Mantel-Haenszel|||||||0.012
71071949|NCT00380081|141652456|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
71071950|NCT00380081|141652457|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
71071951|NCT00380081|141652458|SUPERIORITY_OR_OTHER|||||||0.79||95.0||||Treatment effect|ANCOVA|||||||0.790
71071952|NCT00380081|141652459|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||Treatment effect|ANCOVA|||||||0.083
71071953|NCT00380081|141652460|SUPERIORITY_OR_OTHER|||||||0.072||95.0||||Treatment effect|ANCOVA|||||||0.072
70853071|NCT00955201|141194690|SUPERIORITY|||||||0.31|||||||ANOVA|||Comparison across groups at 12-wks||||0.31
70853072|NCT00955201|141194690|SUPERIORITY|||||||0.32|||||||ANOVA|||Comparison across groups at 24-wks||||0.32
70939837|NCT06312566|141380161|EQUIVALENCE|Bioequivalence between the BRV tablet (reference) and BRV dry syrup (test) formulations were concluded if the 90% CI limits for AUC(tau) was within the 0.80 to 1.25 range.|Ratio of Dry Syrup/ Tablet|0.9999|||||TWO_SIDED|92.016|0.9881|1.012||||||||1.012|0.9881|
71071954|NCT00380081|141652460|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Period effect|ANCOVA|||||||<0.001
71071955|NCT00380081|141652461|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||Treatment effect|ANCOVA|||||||0.017
71071956|NCT02231879|141652463|SUPERIORITY|This is a two-sided test, with the null hypothesis that the distribution of the difference scores is the same in both arms.||||||0.65||||||Not adjusted for multiple comparisons, since this is the only pre-specified primary analysis. P\<=0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||This was a pre-specified primary analysis plan, and the two arms are compared with a Wilcoxon-Mann-Whitney test on the primary outcome. This is non-standard (since both arms contain both treatment groups), however, it is a valid test by randomization since it is a permutation test. The statistic of TISS in Period 1 minus TISS in Period 2 was chosen so that even if there are carry-over effects this will give a valid test.||||0.65
71071957|NCT02231879|141652463|SUPERIORITY||||||<|0.0001||||||Not adjusted for multiple comparisons, one-sided test, a priori significance set at 0.025|McNemar|||Maintenance of absolute lymphocyte count greater than 1000 cells/microliter measured 3 hours after a dose for plerixafor as compared to G-CSF||||<0.0001
71071958|NCT02231879|141652463|NON_INFERIORITY|Pre-specified non-inferiority margin of 0.40 which was estimated to be about 50% of the effect size of G-CSF versus placebo.||||||0.023||||||Not adjusted for multiple comparisons, one-sided test, a priori significance set at 0.025|McNemar|||Maintenance of absolute neutrophil counts \>500 cells/microliter for G-CSF versus plerixafor measured as the proportion of successes (75% of measured) while on G-CSF minus the proportion on plerixafor||||0.023
70939838|NCT04736472|141380168|SUPERIORITY|||||||0.224|||||||Fisher Exact|||Severe TRAEs||||.224
71071959|NCT01210495|141652542|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.907||||0.2872|TWO_SIDED|95.0|0.646|1.274||For the overall stratified analysis the p-value is from a 1-sided log-rank test of treatment stratified by tumor invasion and geographic region.|Log Rank||Assuming proportional hazards, a hazard ratio less than (\<) 1 indicated reduction in hazard rate to favor Axitinib; hazard ratio greater than (\>) 1 indicated reduction to favor Placebo.|The study was designed to test the null hypothesis that the true median OS was 5 months vs. the alternative hypothesis that the true median OS was at least 8.3 months (i.e., 66 percent \[%\] improvement in median OS).||1.274|0.646|0.2872
71071960|NCT01210495|141652543|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.618||||0.0039|TWO_SIDED|95.0|0.438|0.871||For the overall stratified analysis the p-value is from a 1-sided log-rank test of treatment stratified by tumor invasion and geographic region.|Log Rank||Assuming proportional hazards, a hazard ratio \<1 indicated a reduction in hazard rate in favor of Axitinib; a hazard ratio \>1 indicated a reduction in favor of Placebo.|||0.871|0.438|0.0039
71071961|NCT01210495|141652544|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.172||||0.0914|TWO_SIDED|95.0|0.759|13.265||ORR for the 2 treatment arms was compared with a significance level of 0.025 using Cochran-Mantel-Haenszel (CMH) test for stratified analyses.|Cochran-Mantel-Haenszel||Risk ratio and confidence interval (CI) were based on the Mantel-Haenszel estimator; risk ratio was adjusted for geographical region and vascular invasion and extra hepatic spread.|||13.265|0.759|0.0914
71071962|NCT01210495|141652545|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.621||||0.006|TWO_SIDED|95.0|0.434|0.889||For the overall stratified analysis the p-value is from a 1-sided log-rank test of treatment stratified by tumor invasion and geographic region.|Log Rank||Assuming proportional hazards, a hazard ratio \<1 indicated a reduction in hazard rate in favor of Axitinib; a hazard ratio \>1 indicated a reduction in favor of Placebo.|||0.889|0.434|0.006
71071963|NCT01210495|141652547|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.65||||0.0025|TWO_SIDED|95.0|1.319|5.326||For the overall stratified analysis the p-value is from Cochran-Mantel-Haenszel test of treatment stratified by geographical region and vascular invasion and extra hepatic spread.|Cochran-Mantel-Haenszel||Risk Ratio and CI based on the Mantel-Haenszel estimator; risk ratio was adjusted for geographical region and vascular invasion and extra hepatic spread.|||5.326|1.319|0.0025
71071964|NCT01210495|141652556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.89||||0.0006|TWO_SIDED|95.0|-18.7|-5.08||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-5.08|-18.70|0.0006
71071965|NCT01210495|141652557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.6||||0.0014|TWO_SIDED|95.0|-12.27|-2.94||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-2.94|-12.27|0.0014
71071966|NCT01210495|141652558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.27|||<|0.0001|TWO_SIDED|95.0|-4.76|-1.78||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-1.78|-4.76|<0.0001
71071967|NCT01210495|141652559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.74|||<|0.0001|TWO_SIDED|95.0|-5.26|-2.21||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis presented above is for FACT-G PWB. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-2.21|-5.26|<0.0001
71071968|NCT01210495|141652559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.27||||0.1642|TWO_SIDED|95.0|-3.07|0.52||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis presented above is for FACT-G SWB. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||0.52|-3.07|0.1642
71071969|NCT01210495|141652559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.4759|TWO_SIDED|95.0|-1.8|0.84||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis presented above is for FACT-G EWB. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||0.84|-1.80|0.4759
71071970|NCT01210495|141652559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.07||||0.0288|TWO_SIDED|95.0|-3.92|-0.21||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis presented above is for FACT-G FWB. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-0.21|-3.92|0.0288
71114568|NCT02388165|141737310|SUPERIORITY||Difference in percentage of participants|0.8|||||TWO_SIDED|95.0|-1.5|3.0||||||Diarrhea: Mild||3.0|-1.5|
71114569|NCT02388165|141737310|SUPERIORITY||Difference in percentage of participants|0.5||||||95.0|-0.7|1.7||||||Diarrhea: Moderate||1.7|-0.7|
71114570|NCT02388165|141737310|SUPERIORITY||Difference in percentage of participants|-0.4|||||TWO_SIDED|95.0|-1.0|0.2||||||Diarrhea: Severe||0.2|-1.0|
71114571|NCT02388165|141737310|SUPERIORITY||Difference in percentage of participants|-0.6||||0.3||95.0|-1.8|0.5|||Miettinen and Nurminen|||Vomiting: Any||0.5|-1.8|0.300
71114572|NCT02388165|141737310|SUPERIORITY||Difference in percentage of participants|-0.2|||||TWO_SIDED|95.0|-1.3|0.8||||||Vomiting: Mild||0.8|-1.3|
70853073|NCT00955201|141194691|SUPERIORITY|||||||0.81||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.81
71114573|NCT02388165|141737310|SUPERIORITY||Difference in percentage of participants|-0.4||||||95.0|-0.9|0.1||||||Vomiting: Moderate||0.1|-0.9|
70939839|NCT04736472|141380168|SUPERIORITY|||||||0.025|||||||Fisher Exact|||Severe TRAEs||||.025
70939840|NCT02971683|141380186|SUPERIORITY||Odds Ratio (OR)|1.8||||0.083|TWO_SIDED|95.0|0.9|3.5|||Regression, Logistic|||||3.5|0.9|0.083
70939841|NCT04206501|141380200|SUPERIORITY|||||||0.064||||||The rate of change in HF medications (beta-blocker, diuretic, and Sacubitril/Valsartan) was compared betweenICM Guidedand usual care control group using chi-square analysis.|Chi-squared|||Due to the unexpected low enrollment during COVID pandemic, we aimed to primarily focus the limited analysis/description on the primary endpoint and exploratory analysis related to QOL||||0.064
70853074|NCT00955201|141194691|SUPERIORITY|||||||0.92||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.92
70939842|NCT02268526|141380202|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.891|||||TWO_SIDED|90.0|0.606|1.305||||||||1.305|0.606|
70939843|NCT02268526|141380202|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.941|||||TWO_SIDED|90.0|0.639|1.377||||||||1.377|0.639|
70939844|NCT01292005|141380221|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 1. p\<0.05 was considered statistically significant.||||0.62
70939845|NCT01292005|141380221|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 3. p\<0.05 was considered statistically significant.||||1.0
71071971|NCT01210495|141652560|SUPERIORITY||Mean Difference (Final Values)|-4.96||||0.0011|TWO_SIDED|95.0|-7.93|-1.99||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-1.99|-7.93|0.0011
71071972|NCT01210495|141652561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.45|||<|0.0001|TWO_SIDED|95.0|-15.49|-5.42||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-5.42|-15.49|<0.0001
71071973|NCT01210495|141652562|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.252||||0.9182|TWO_SIDED|95.0|0.923|1.698||The p-value is from a 1-sided log-rank test.|1-sided, unstratified log-rank test||Assuming proportional hazards, a hazard ratio \<1 indicates reduction in hazard rate to favor Axitinib, hazard ratio \>1 indicates reduction to favor Placebo.|||1.698|0.923|0.9182
71071974|NCT01210495|141652563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.0024|TWO_SIDED|95.0|-0.2|-0.04|||Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-0.04|-0.20|0.0024
71071975|NCT01210495|141652564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.03||||0.0193|TWO_SIDED|95.0|-12.91|-1.15|||Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-1.15|-12.91|0.0193
71071976|NCT00985959|141652585|SUPERIORITY_OR_OTHER||Overall response rate (%)|69.8|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001|TWO_SIDED|95.0|58.9|79.2||Significance level 5% one-tailed. Threshold response rate 35%|Binominal test|||||79.2|58.9|<0.0001
71071977|NCT00574249|141652611|SUPERIORITY_OR_OTHER|||||||0.086||||||Level of significance 5%; no adjustment for multiple comparisons necessary.|Cochran-Mantel-Haenszel|Two-sided CMH test stratified by country at the alpha level 0.05. Centers were pooled by country (Sweden and Finland pooled due to few participants).||Comparison of the proportion of participants in the adalimumab + calcipotriol/betamethasone group vs. the adalimumab + placebo group.||||0.086
71071978|NCT00574249|141652612|SUPERIORITY_OR_OTHER|||||||0.565||95.0|||||Fisher Exact|||||||0.565
70939846|NCT01292005|141380222|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 1. p\<0.05 was considered statistically significant.||||0.72
71071979|NCT00574249|141652613|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Fisher Exact|||||||0.002
71071980|NCT00574249|141652614|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||||||0.003
71071981|NCT00574249|141652615|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Fisher Exact|||||||0.004
70939847|NCT01292005|141380222|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 3. p\<0.05 was considered statistically significant.||||0.50
70939848|NCT01292005|141380223|SUPERIORITY_OR_OTHER|||||||0.58||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 1. p\<0.05 was considered statistically significant.||||0.58
70939849|NCT01292005|141380223|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 3. p\<0.05 was considered statistically significant.||||0.80
70939850|NCT01292005|141380224|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 1. p\<0.05 was considered statistically significant.||||0.90
70939851|NCT01292005|141380224|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 3. p\<0.05 was considered statistically significant.||||0.56
70939852|NCT01292005|141380225|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Wilcoxon (Mann-Whitney)|||p\<0.05 was considered statistically significant.||||0.09
70939853|NCT01292005|141380226|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Wilcoxon (Mann-Whitney)|||p\<0.05 was considered statistically significant.||||0.22
70939854|NCT01292005|141380227|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||t-test, 2 sided|||Comparison between arms for length of hospitalization \> 4 days. P \< 0.05 was considered statistically significant.||||0.04
70939855|NCT01292005|141380227|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||t-test, 2 sided|||Comparison was for length of hospitalization \>10 days. P \< 0.05 was considered statistically significant.||||0.03
70939856|NCT01292005|141380228|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||t-test, 2 sided|||P \< 0.05 was considered statistically significant.||||0.06
70939857|NCT01292005|141380229|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||P \< 0.05 was considered statistically significant.||||0.03
70939858|NCT01292005|141380230|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Wilcoxon (Mann-Whitney)|||P \< 0.05 was considered statistically significant.||||0.04
70939859|NCT00936065|141380237|SUPERIORITY_OR_OTHER|||||||0.0672|TWO_SIDED||||||Fisher Exact|||Overall treatment difference||||0.0672
71071982|NCT00574249|141652616|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||Fisher Exact|||||||0.011
71071983|NCT00574249|141652617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.74||||0.204||95.0|-5.3|24.78|||ANOVA|One-way ANOVA. For confidence interval and difference estimate, adalimumab + calcipotriol/betamethasone minus adalimumab + placebo was used.||||24.78|-5.30|0.204
71071984|NCT00574249|141652618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.55||||0.272||95.0|-48.92|13.82|||ANOVA|One-way ANOVA. Confidence interval and difference estimated from adalimumab + calcipotriol/betamethasone minus adalimumab + placebo.||||13.82|-48.92|0.272
70853075|NCT00955201|141194691|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.93
71071985|NCT00574249|141652619|SUPERIORITY_OR_OTHER|||||||0.413||95.0|||||Fisher Exact|||||||0.413
71071986|NCT00574249|141652620|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71071987|NCT00574249|141652621|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Fisher Exact|||||||0.028
71071988|NCT00574249|141652622|SUPERIORITY_OR_OTHER|||||||0.228||95.0|||||ANOVA|One-way ANOVA.||||||0.228
71071989|NCT00574249|141652623|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|One-way ANOVA.||||||< 0.001
70939860|NCT00936065|141380238|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Overall treatment difference Week 2||||1.0000
71114574|NCT02388165|141737310|SUPERIORITY||Difference in percentage of participants|1.7||||0.276||95.0|-1.3|4.7|||Miettinen and Nurminen|||Muscle pain: Any||4.7|-1.3|0.276
71114575|NCT02388165|141737310|SUPERIORITY||Difference in percentage of participants|0.8|||||TWO_SIDED|95.0|-1.2|2.8||||||Muscle pain: Mild||2.8|-1.2|
70853076|NCT00955201|141194691|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.99
70853077|NCT00955201|141194691|SUPERIORITY|||||||0.5|||||||ANOVA|||Comparison across groups at baseline.||||0.50
70853078|NCT00955201|141194691|SUPERIORITY|||||||0.47|||||||ANOVA|||Comparison across groups at 12-wks.||||0.47
70853079|NCT00955201|141194691|SUPERIORITY|||||||0.97|||||||ANOVA|||Comparison across groups at 24-wks||||0.97
70853080|NCT00955201|141194692|SUPERIORITY|||||||0.83||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.83
70853081|NCT00955201|141194692|SUPERIORITY|||||||0.91||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.91
70853082|NCT00955201|141194692|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||1.00
70853083|NCT00955201|141194692|SUPERIORITY|||||||0.95||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.95
70853084|NCT00955201|141194692|SUPERIORITY|||||||0.26|||||||ANOVA|||Comparison across groups at baseline.||||0.26
70853085|NCT00955201|141194692|SUPERIORITY|||||||0.42|||||||ANOVA|||Comparison across groups at 12-wks||||0.42
70939861|NCT00936065|141380238|SUPERIORITY_OR_OTHER|||||||0.0229|TWO_SIDED||||||Fisher Exact|||Overall treatment difference Week 4||||0.0229
70939862|NCT00936065|141380238|SUPERIORITY_OR_OTHER|||||||0.0256|TWO_SIDED||||||Fisher Exact|||Overall treatment difference Week 8||||0.0256
70939863|NCT00936065|141380238|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||Fisher Exact|||Overall treatment difference Week 12||||0.0004
70939864|NCT00936065|141380238|SUPERIORITY_OR_OTHER|||||||0.0105|TWO_SIDED||||||Fisher Exact|||Overall treatment difference Week 18||||0.0105
70939865|NCT00936065|141380238|SUPERIORITY_OR_OTHER|||||||0.0366|TWO_SIDED||||||Fisher Exact|||Overall treatment difference Week 24||||0.0366
70939866|NCT00936065|141380239|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 8||||1.0000
70939867|NCT00936065|141380239|SUPERIORITY_OR_OTHER|||||||0.323|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 12||||0.3230
70939868|NCT00936065|141380239|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 18||||1.0000
70939869|NCT00936065|141380239|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 24||||1.0000
71114576|NCT02388165|141737310|SUPERIORITY||Difference in percentage of participants|1.1|||||TWO_SIDED|95.0|-1.4|3.5||||||Muscle pain: Moderate||3.5|-1.4|
71114577|NCT02388165|141737310|SUPERIORITY||Difference in percentage of participants|-0.2||||||95.0|-1.2|0.8||||||Muscle pain: Severe||0.8|-1.2|
70853086|NCT00955201|141194692|SUPERIORITY|||||||0.95|||||||ANOVA|||Comparison across groups at 24-wks.||||0.95
70853087|NCT00955201|141194693|SUPERIORITY|||||||0.96||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.96
70853088|NCT00955201|141194693|SUPERIORITY|||||||0.53||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.53
70853089|NCT00955201|141194693|SUPERIORITY|||||||0.79||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.79
70853090|NCT00955201|141194693|SUPERIORITY|||||||0.94||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.94
70853091|NCT00955201|141194693|SUPERIORITY|||||||0.75|||||||ANOVA|||Comparison across groups at baseline||||0.75
70853092|NCT00955201|141194693|SUPERIORITY|||||||0.51|||||||ANOVA|||Comparison across groups at 12-wks||||0.51
70853093|NCT00955201|141194693|SUPERIORITY|||||||0.63|||||||ANOVA|||Comparison across groups at 24-wks.||||0.63
70853094|NCT00955201|141194694|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.98
70853095|NCT00955201|141194694|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.99
70853096|NCT00955201|141194694|SUPERIORITY|||||||0.89||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.89
70853097|NCT00955201|141194694|SUPERIORITY|||||||0.9||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.90
70853098|NCT00955201|141194694|SUPERIORITY|||||||0.98|||||||ANOVA|||Comparison across groups at baseline||||0.98
70853099|NCT00955201|141194694|SUPERIORITY|||||||0.94|||||||ANOVA|||Comparison across groups at 12-wks||||0.94
70853100|NCT00955201|141194694|SUPERIORITY|||||||0.91|||||||ANOVA|||Comparison across groups at 24-wks.||||0.91
70853101|NCT00955201|141194695|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.98
70853102|NCT00955201|141194695|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.99
70853103|NCT00955201|141194695|SUPERIORITY|||||||0.84||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.84
70853104|NCT00955201|141194695|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
70853105|NCT00955201|141194695|SUPERIORITY|||||||0.96|||||||ANOVA|||Comparison across groups at baseline.||||0.96
70853106|NCT00955201|141194695|SUPERIORITY|||||||0.86|||||||ANOVA|||Comparison across groups at 12-wks.||||0.86
70853107|NCT00955201|141194695|SUPERIORITY|||||||0.92|||||||ANOVA|||Comparison across groups at 24-wks.||||0.92
70853108|NCT00955201|141194696|SUPERIORITY|||||||0.03||||||Unpaired two-tailed t-test:|t-test, 2 sided|||Evaluate within group pre- and post-test responses across time.||||0.03
71114578|NCT02388165|141737310|SUPERIORITY||Difference in percentage of participants|1.7||||0.273|TWO_SIDED|95.0|-1.3|4.6|||Miettinen and Nurminen|||Joint pain: Any||4.6|-1.3|0.273
71114579|NCT02388165|141737310|SUPERIORITY||Difference in percentage of participants|1.6|||||TWO_SIDED|95.0|-0.2|3.6||||||Joint pain: Mild||3.6|-0.2|
71114580|NCT02388165|141737310|SUPERIORITY||Difference in percentage of participants|0.0|||||TWO_SIDED|95.0|-2.6|2.4||||||Joint pain: Moderate||2.4|-2.6|
71114581|NCT02388165|141737310|SUPERIORITY||Difference in percentage of participants|0.1||||||95.0|-0.9|1.0||||||Joint pain: Severe||1.0|-0.9|
71114582|NCT02388165|141737318|SUPERIORITY||VE|0.0|||||TWO_SIDED|95.0|-126.3|55.81|||||VE was calculated as 1-(P/\[1-P\]\*100), where P is the number of SA4Ag cases divided by the total number of cases. The CI was calculated using the Clopper-Pearson method.|||55.81|-126.30|
71114583|NCT02388165|141737319|SUPERIORITY||VE|-9.09|||||TWO_SIDED|95.0|-104.06|41.41|||||VE was calculated as 1-(P/\[1-P\]\*100), where P is the number of SA4Ag cases divided by the total number of cases. The CI was calculated using the Clopper-Pearson method.|||41.41|-104.06|
71114584|NCT02388165|141737320|SUPERIORITY||VE|-8.7|||||TWO_SIDED|95.0|-100.42|40.8|||||VE was calculated as 1-(P/\[1-P\]\*100), where P is the number of SA4Ag cases divided by the total number of cases. The CI was calculated using the Clopper-Pearson method.|||40.80|-100.42|
71114585|NCT01667224|141737347|NON_INFERIORITY_OR_EQUIVALENCE|Data are present as the mean±S.E. to detect a 0.3kg(S.D.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.|||||<|0.05|||||||Mixed Models Analysis|||Data are present as the mean±S.E. to detect a 0.3kg(S.D.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.||||<0.05
71114586|NCT01667224|141737348|NON_INFERIORITY_OR_EQUIVALENCE|Data are present as the mean±S.D. to detect a 0.3kg(S.E.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.|||||<|0.05|||||||Mixed Models Analysis|||Data are present as the mean±S.D. to detect a 0.3kg(S.E.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.||||<0.05
71114587|NCT01667224|141737349|NON_INFERIORITY_OR_EQUIVALENCE|Data are present as the mean±S.D. to detect a 0.3kg(S.E.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.|||||<|0.05|||||||Mixed Models Analysis|||Data are present as the mean±S.D. to detect a 0.3kg(S.E.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.||||<0.05
71114588|NCT01667224|141737350|NON_INFERIORITY_OR_EQUIVALENCE|Data are present as the mean±S.E. to detect a 0.3kg(S.D.=0.60kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.|||||<|0.05|||||||Mixed Models Analysis|||Data are present as the mean±S.E. to detect a 0.3kg(S.D.=0.60kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.||||<0.05
71114589|NCT01942668|141737368|SUPERIORITY||Mean Difference (Final Values)|-12.81|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-19.29|-6.32||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-6.32|-19.29|<0.001
71114590|NCT01942668|141737368|SUPERIORITY||Mean Difference (Final Values)|-8.07|STANDARD_ERROR_OF_MEAN|3.25||0.013|TWO_SIDED|95.0|-14.46|-1.68||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-1.68|-14.46|0.013
71114591|NCT01942668|141737368|SUPERIORITY||Mean Difference (Final Values)|-4.81|STANDARD_ERROR_OF_MEAN|3.26||0.141|TWO_SIDED|95.0|-11.21|1.59||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||1.59|-11.21|0.141
71114592|NCT01942668|141737368|SUPERIORITY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|3.22||0.001|TWO_SIDED|95.0|-16.73|-4.08||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-4.08|-16.73|0.001
71114593|NCT01942668|141737369|SUPERIORITY||Mean Difference (Final Values)|-16.58|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-23.33|-9.82||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-9.82|-23.33|<0.001
71114594|NCT01942668|141737369|SUPERIORITY||Mean Difference (Final Values)|-15.07|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-21.72|-8.42||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-8.42|-21.72|<0.001
71114595|NCT01942668|141737369|SUPERIORITY||Mean Difference (Final Values)|-10.79|STANDARD_ERROR_OF_MEAN|3.41||0.002|TWO_SIDED|95.0|-17.48|-4.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-4.10|-17.48|0.002
71114596|NCT01942668|141737369|SUPERIORITY||Mean Difference (Final Values)|-11.71|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|-18.31|-5.11||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-5.11|-18.31|<0.001
70853109|NCT00955201|141194696|SUPERIORITY|||||||0.29||||||Unpaired two-tailed t-test:|t-test, 2 sided|||Evaluate within group pre- and post-test responses across time.||||0.29
70853110|NCT00955201|141194696|SUPERIORITY|||||||0.36||||||Unpaired two-tailed t-test:|t-test, 2 sided|||Evaluate within group pre- and post-test responses across time.||||0.36
70939870|NCT00936065|141380240|SUPERIORITY_OR_OTHER|||||||0.3103|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 2||||0.3103
70939871|NCT00936065|141380240|SUPERIORITY_OR_OTHER|||||||0.4763|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 4||||0.4763
71071990|NCT00574249|141652624|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|One-way ANOVA.||||||0.001
71114597|NCT01942668|141737370|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.061||0.031|TWO_SIDED|95.0|-0.25|-0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-0.01|-0.25|0.031
71071991|NCT00574249|141652625|SUPERIORITY_OR_OTHER|||||||0.764||95.0|||||ANOVA|One-way ANOVA.||||||0.764
71071992|NCT00574249|141652626|SUPERIORITY_OR_OTHER|||||||0.437||95.0|||||ANOVA|One-way ANOVA.||||||0.437
71071993|NCT00574249|141652627|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||ANOVA|One-way ANOVA.||||||0.740
71071994|NCT00574249|141652628|SUPERIORITY_OR_OTHER|||||||0.634||95.0|||||ANOVA|One-way ANOVA.||||||0.634
71071995|NCT00478699|141652644|SUPERIORITY||Hazard Ratio (HR)|0.946||||0.73|TWO_SIDED|95.0|0.689|1.298|||Log Rank|||Based on the relevant clinical evidence of the prognostic and predictive value of BRCA1, proposes the present study with which it is intended to demonstrate that adjuvant chemotherapy Individualized based on BRCA1 expression (Experimental arm), it is more effective than chemotherapy without individualize based (Control arm) in patients with completely resected stage II-IIIA NSCLC.||1.298|0.689|0.73
71071996|NCT00478699|141652645|SUPERIORITY||Median Difference (Final Values)|79.3||||0.753|TWO_SIDED|95.0|63.5|95.1|||Log Rank|||Control Arm v Experimental Arm||95.1|63.5|0.753
71071997|NCT00478699|141652645|SUPERIORITY|The initial hyphotesis were the disease free survival were longest under 65 vs upper 65.|Median Difference (Final Values)|38.7||||0.025|TWO_SIDED|95.0|28.0|38.7|||Log Rank|||Control Arm v Experimental Arm||38.7|28|0.025
71071998|NCT04601103|141652660|OTHER|Generalized Fisher's Exact Test was used to detect an association between the 3 treatment groups and the incidence of sloughing||||||0.916|||||||Fisher Exact|||||||.916
71071999|NCT01203826|141652664|OTHER|||||||0.0005|||||||Wilcoxon signed-rank test|P-value based on Wilcoxon signed-rank test.||Change is relative to Baseline in Study ENB-006-09 (NCT00952484). The RGI-C score represents evaluations of skeletal X-rays at each post-treatment study timepoint in Study ENB-008-10 compared with pre-treatment X-rays from Study ENB-006-09, using an ordinal scale. Therefore, no Baseline data for RGI-C are available.||||0.0005
71072000|NCT04713592|141652686|SUPERIORITY||Rate Difference|17.2|||=|0.006|TWO_SIDED|95.0|5.0|29.3||P-value based on Cochran-Mantel-Haenszel (CMH) test adjusted for Baseline ppIGA and Baseline BSA categories for comparison of treatment groups based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.|Cochran-Mantel-Haenszel||Difference: Risankizumab - Placebo|Risankizumab vs Placebo at Week 16||29.3|5.0|=0.006
71072001|NCT04713592|141652688|SUPERIORITY||Rate Difference|27.6|||<|0.001|TWO_SIDED|95.0|15.4|39.7||P-value based on Cochran-Mantel-Haenszel (CMH) test adjusted for Baseline ppIGA and Baseline BSA categories for comparison of treatment groups based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.|Cochran-Mantel-Haenszel||Difference: Risankizumab - Placebo|Risankizumab vs Placebo at Week 16||39.7|15.4|<0.001
71072002|NCT04713592|141652689|SUPERIORITY||Rate Difference|21.8|||<|0.001|TWO_SIDED|95.0|11.5|32.1||P-value based on Cochran-Mantel-Haenszel (CMH) test adjusted for Baseline ppIGA and Baseline BSA categories for comparison of treatment groups based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.|Cochran-Mantel-Haenszel||Difference: Risankizumab - Placebo|Risankizumab vs Placebo at Week 16||32.1|11.5|<0.001
71072003|NCT04713592|141652690|SUPERIORITY||Rate Difference|20.7|||<|0.001|TWO_SIDED|95.0|9.1|32.2||P-value based on Cochran-Mantel-Haenszel (CMH) test adjusted for Baseline ppIGA and Baseline BSA categories for comparison of treatment groups based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.|Cochran-Mantel-Haenszel||Difference: Risankizumab - Placebo|Risankizumab vs Placebo at Week 16||32.2|9.1|<0.001
71072004|NCT04713592|141652691|SUPERIORITY||Rate Difference|16.2|||<|0.001|TWO_SIDED|95.0|8.2|24.3||P-value based on Cochran-Mantel-Haenszel (CMH) test adjusted for Baseline ppIGA and Baseline BSA categories for comparison of treatment groups based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.|Cochran-Mantel-Haenszel||Difference: Risankizumab - Placebo|Risankizumab vs Placebo at Week 16||24.3|8.2|<0.001
71072005|NCT02548351|141652721|OTHER||Hazard Ratio (HR)|0.814||||0.1028|TWO_SIDED|95.0|0.635|1.043|||Log Rank|||||1.043|0.635|0.1028
71072006|NCT02548351|141652721|OTHER||Hazard Ratio (HR)|0.772||||0.0444|TWO_SIDED|95.0|0.6|0.994|||Log Rank|||||0.994|0.600|0.0444
71072007|NCT02548351|141652722|OTHER||Difference in percentages|7.1|||<|0.0001|TWO_SIDED|95.0|3.6|10.6|||Cochran-Mantel-Haenszel|||||10.6|3.6|<0.0001
71072008|NCT02548351|141652722|OTHER||Treatment difference|9.4|||<|0.0001|TWO_SIDED|95.0|5.8|13.0|||Cochran-Mantel-Haenszel|||||13.0|5.8|<0.0001
71072009|NCT02548351|141652723|OTHER||Treatment difference|6.7||||0.0004|TWO_SIDED|95.0|3.0|10.4|||Cochran-Mantel-Haenszel|||||10.4|3.0|0.0004
71072010|NCT02548351|141652723|OTHER||Treatment difference|9.0|||<|0.0001|TWO_SIDED|95.0|5.2|12.8|||Cochran-Mantel-Haenszel|||||12.8|5.2|<0.0001
71072011|NCT00125242|141652725|SUPERIORITY_OR_OTHER||effect size|7.15|STANDARD_DEVIATION|3.1|||TWO_SIDED||||||||the reported effect size is a d-index value|Effect sizes were calculated - this is a comparison of perfomance in baseline (repeated measurements prior to treatment) relative to peformance following treatment||||
71072012|NCT03051516|141652752|SUPERIORITY|||||||0.89|||||||Chi-squared|||This p-value compares HPV16 persistence by study arm.||||0.89
71072013|NCT03051516|141652752|SUPERIORITY|||||||0.65|||||||Chi-squared|||This p-value compares HPV18/45 persistence by study arm.||||0.65
71072014|NCT03051516|141652752|SUPERIORITY|||||||0.056|||||||Chi-squared|||This p-value compares HPV31/33/52/58 persistence by study arm.||||0.056
71072015|NCT03051516|141652752|SUPERIORITY|||||||0.38|||||||Chi-squared|||This p-value compares HPV35/39/51/56/59 persistence by study arm.||||0.38
71072016|NCT03051516|141652752|SUPERIORITY|||||||0.33||||||This p-value compares overall HPV persistence and is not specific to HPV genotype.|Chi-squared|||||||0.33
71072017|NCT03051516|141652753|SUPERIORITY|||||||0.54|||||||Log Rank|||||||0.54
71072018|NCT03051516|141652754|OTHER|Descriptive analysis||||||0.135|||||||Chi-squared|||This comparison is specific to the incidence of fever or chills.||||0.135
70939872|NCT00936065|141380240|SUPERIORITY_OR_OTHER|||||||0.1961|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 8||||0.1961
71114598|NCT01942668|141737370|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.005|TWO_SIDED|95.0|-0.28|-0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-0.05|-0.28|0.005
70939873|NCT00936065|141380240|SUPERIORITY_OR_OTHER|||||||0.0272|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 12||||0.0272
70939874|NCT00936065|141380240|SUPERIORITY_OR_OTHER|||||||0.5038|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 18||||0.5038
70939875|NCT00936065|141380240|SUPERIORITY_OR_OTHER|||||||0.0374|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 24||||0.0374
70939876|NCT00936065|141380241|SUPERIORITY_OR_OTHER|||||||0.6061|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Baseline||||0.6061
71114599|NCT01942668|141737370|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.06||0.401|TWO_SIDED|95.0|-0.17|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||0.07|-0.17|0.401
71114600|NCT01942668|141737370|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.059||0.1|TWO_SIDED|95.0|-0.21|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||0.02|-0.21|0.100
71114601|NCT01942668|141737371|SUPERIORITY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.77|-0.38||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-0.38|-0.77|<0.001
71114602|NCT01942668|141737371|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.59|-0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-0.20|-0.59|<0.001
70939877|NCT00936065|141380241|SUPERIORITY_OR_OTHER|||||||0.2971|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 2||||0.2971
70939878|NCT00936065|141380241|SUPERIORITY_OR_OTHER|||||||0.1119|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 4||||0.1119
70939879|NCT00936065|141380241|SUPERIORITY_OR_OTHER|||||||0.1081|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 8||||0.1081
70939880|NCT00936065|141380241|SUPERIORITY_OR_OTHER|||||||0.0063|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 12||||0.0063
70939881|NCT00936065|141380241|SUPERIORITY_OR_OTHER|||||||0.0055|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 18||||0.0055
70939882|NCT00936065|141380241|SUPERIORITY_OR_OTHER|||||||0.0031|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 24||||0.0031
70939883|NCT00936065|141380242|SUPERIORITY_OR_OTHER|||||||0.0033|TWO_SIDED||||||Log Rank|||Overall treatment difference||||0.0033
70939884|NCT00936065|141380243|SUPERIORITY_OR_OTHER|||||||0.0448|TWO_SIDED||||||Log Rank|||Overall treatment difference||||0.0448
70939885|NCT00936065|141380244|SUPERIORITY_OR_OTHER|||||||0.0041|TWO_SIDED||||||Log Rank|||Overall treatment difference||||0.0041
70939886|NCT00936065|141380245|SUPERIORITY_OR_OTHER|||||||0.3536|TWO_SIDED||||||Log Rank|||Overall treatment difference||||0.3536
70939887|NCT00936065|141380246|SUPERIORITY_OR_OTHER|||||||0.0203|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 2||||0.0203
70939888|NCT00936065|141380246|SUPERIORITY_OR_OTHER|||||||0.0102|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 4||||0.0102
70939889|NCT00936065|141380246|SUPERIORITY_OR_OTHER|||||||0.0056|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 8||||0.0056
70939890|NCT00936065|141380246|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 12||||0.0006
70939891|NCT00936065|141380246|SUPERIORITY_OR_OTHER|||||||0.0066|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 18||||0.0066
70939892|NCT00936065|141380246|SUPERIORITY_OR_OTHER|||||||0.0058|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 24||||0.0058
70939893|NCT00936065|141380247|SUPERIORITY_OR_OTHER|||||||0.0329|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 2||||0.0329
70939894|NCT00936065|141380247|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 4||||0.0003
70939895|NCT00936065|141380247|SUPERIORITY_OR_OTHER|||||||0.0598|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 8||||0.0598
70939896|NCT00936065|141380247|SUPERIORITY_OR_OTHER|||||||0.0241|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 12||||0.0241
70939897|NCT00936065|141380247|SUPERIORITY_OR_OTHER|||||||0.0543|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 18||||0.0543
70939898|NCT00936065|141380247|SUPERIORITY_OR_OTHER|||||||0.1205|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 24||||0.1205
70939899|NCT00936065|141380248|SUPERIORITY_OR_OTHER|||||||0.1385|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 2||||0.1385
70939900|NCT00936065|141380248|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 4||||0.0019
70939901|NCT00936065|141380248|SUPERIORITY_OR_OTHER|||||||0.0442|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 8||||0.0442
70939902|NCT00936065|141380248|SUPERIORITY_OR_OTHER|||||||0.0034|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 12||||0.0034
70939903|NCT00936065|141380248|SUPERIORITY_OR_OTHER|||||||0.0454|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 18||||0.0454
70939904|NCT00936065|141380248|SUPERIORITY_OR_OTHER|||||||0.0539|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 24||||0.0539
70939905|NCT00936065|141380249|SUPERIORITY_OR_OTHER|||||||0.1723|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 2||||0.1723
71114603|NCT01942668|141737371|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.1||0.018|TWO_SIDED|95.0|-0.43|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-0.04|-0.43|0.018
71114604|NCT01942668|141737371|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.098||0.096|TWO_SIDED|95.0|-0.36|0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||0.03|-0.36|0.096
70853111|NCT00955201|141194696|SUPERIORITY|||||||0.15||||||Unpaired two-tailed t-test:|t-test, 2 sided|||Evaluate within group pre- and post-test responses across time.||||0.15
70853112|NCT00955201|141194696|SUPERIORITY|||||||0.2||||||ANOVA|ANOVA|||Comparison of pre- and post-responses across groups at baseline.||||0.20
70853113|NCT00955201|141194696|SUPERIORITY|||||||0.51||||||ANOVA|ANOVA|||Comparison of pre- and post-test responses across groups at 12 wks.||||0.51
70853114|NCT00955201|141194696|SUPERIORITY|||||||0.59||||||ANOVA|ANOVA|||Comparison of pre- and post-test responses across groups at 24 wks.||||0.59
70853115|NCT00955201|141194697|SUPERIORITY|||||||1||||||Dunn's multiple comparisons|Kruskal-Wallis|||Evaluate within group across time||||1.00
70853116|NCT00955201|141194697|SUPERIORITY|||||||0.01||||||Dunn's multiple comparisons|Kruskal-Wallis|||Evaluate within group across time||||0.01
70853117|NCT00955201|141194697|SUPERIORITY|||||||1||||||Dunn's multiple comparisons|Kruskal-Wallis|||Evaluate within group across time||||1.00
70853118|NCT00955201|141194697|SUPERIORITY|||||||0.98||||||Dunn's multiple comparisons|Kruskal-Wallis|||Evaluate within group across time||||0.98
70853119|NCT00955201|141194697|SUPERIORITY|||||||0.96|||||||Kruskal-Wallis|||Comparison across groups at baseline||||0.96
70853120|NCT00955201|141194697|SUPERIORITY|||||||0.06|||||||Kruskal-Wallis|||Comparison across groups at 12-wks||||0.06
70853121|NCT00955201|141194697|SUPERIORITY|||||||0.14|||||||Kruskal-Wallis|||Comparison across groups at 24-wks||||0.14
70853122|NCT00955201|141194698|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
70939906|NCT00936065|141380249|SUPERIORITY_OR_OTHER|||||||0.0292|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 4||||0.0292
70939907|NCT00936065|141380249|SUPERIORITY_OR_OTHER|||||||0.0908|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 8||||0.0908
70853123|NCT00955201|141194698|SUPERIORITY|||||||0.36||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.36
70853124|NCT00955201|141194698|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.93
70853125|NCT00955201|141194698|SUPERIORITY|||||||0.46||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.46
70853126|NCT00955201|141194698|SUPERIORITY|||||||0.14|||||||ANOVA|||Comparison across groups at baseline.||||0.14
70853127|NCT00955201|141194698|SUPERIORITY|||||||0.05|||||||ANOVA|||Comparison across groups at 12 wks.||||0.05
70853128|NCT00955201|141194698|SUPERIORITY|||||||0.01|||||||ANOVA|||Comparison across groups at 24 wks.||||0.01
70853129|NCT00955201|141194699|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.98
70853130|NCT00955201|141194699|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.98
70853131|NCT00955201|141194699|SUPERIORITY|||||||0.67||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.67
70853132|NCT00955201|141194699|SUPERIORITY|||||||0.55||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.55
70853133|NCT00955201|141194699|SUPERIORITY|||||||0.4||||||Tukey's multiple comparisons test:|ANOVA|||Comparison across groups at baseline.||||0.40
70853134|NCT00955201|141194699|SUPERIORITY|||||||0.47|||||||ANOVA|||Comparison across groups at 12 wks.||||0.47
70853135|NCT00955201|141194699|SUPERIORITY|||||||0.43|||||||ANOVA|||Comparison across groups at 24 wks.||||0.43
70853136|NCT00955201|141194700|SUPERIORITY|||||||0.84||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.84
70853137|NCT00955201|141194700|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.93
70853138|NCT00955201|141194700|SUPERIORITY|||||||0.94||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.94
70853139|NCT00955201|141194700|SUPERIORITY|||||||0.94||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.94
70853140|NCT00955201|141194700|SUPERIORITY|||||||0.88|||||||ANOVA|||Comparison across groups at baseline.||||0.88
70853141|NCT00955201|141194700|SUPERIORITY|||||||0.48|||||||ANOVA|||Comparison across groups at 12 wks.||||0.48
70853142|NCT00955201|141194700|SUPERIORITY|||||||0.38|||||||ANOVA|||Comparison across groups at 24 wks.||||0.38
70853143|NCT00955201|141194701|SUPERIORITY|||||||0.87||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.87
70853144|NCT00955201|141194701|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.93
70853145|NCT00955201|141194701|SUPERIORITY|||||||0.51||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.51
70853146|NCT00955201|141194701|SUPERIORITY|||||||0.89||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.89
70939908|NCT00936065|141380249|SUPERIORITY_OR_OTHER|||||||0.5678|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 12||||0.5678
70939909|NCT00936065|141380249|SUPERIORITY_OR_OTHER|||||||0.482|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 18||||0.4820
70939910|NCT00936065|141380249|SUPERIORITY_OR_OTHER|||||||0.0394|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 24||||0.0394
70939911|NCT00936065|141380250|SUPERIORITY_OR_OTHER|||||||0.1079|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 2||||0.1079
70939912|NCT00936065|141380250|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 4||||0.0004
70939913|NCT00936065|141380250|SUPERIORITY_OR_OTHER|||||||0.0146|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 8||||0.0146
70939914|NCT00936065|141380250|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 12||||0.0019
70939915|NCT00936065|141380250|SUPERIORITY_OR_OTHER|||||||0.0062|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 18||||0.0062
70939916|NCT00936065|141380250|SUPERIORITY_OR_OTHER|||||||0.0197|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 24||||0.0197
70939917|NCT00936065|141380251|SUPERIORITY_OR_OTHER|||||||0.1229|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 2||||0.1229
71072019|NCT03051516|141652754|OTHER|Descriptive analysis||||||0.64|||||||Chi-squared|||This comparison is specific to the incidence of headache.||||0.640
71072020|NCT03051516|141652754|OTHER|Descriptive analysis||||||0.838|||||||Chi-squared|||This comparison is specific to the incidence of fatigue.||||0.838
71072021|NCT03051516|141652754|OTHER|Descriptive analysis||||||0.917|||||||Chi-squared|||This comparison is specific to the incidence of muscle aches.||||0.917
71114605|NCT01942668|141737372|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||1.06||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 1 mg / Progesterone 100 mg.||1.06||
71072022|NCT03051516|141652754|OTHER|Descriptive analysis||||||0.005|||||||Chi-squared|||This comparison is specific to the incidence of pain at injection site.||||0.005
70939918|NCT00936065|141380251|SUPERIORITY_OR_OTHER|||||||0.0136|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 4||||0.0136
70939919|NCT00936065|141380251|SUPERIORITY_OR_OTHER|||||||0.1578|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 8||||0.1578
70939920|NCT00936065|141380251|SUPERIORITY_OR_OTHER|||||||0.0565|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 12||||0.0565
70939921|NCT00936065|141380251|SUPERIORITY_OR_OTHER|||||||0.0685|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 18||||0.0685
71072023|NCT03051516|141652754|OTHER|Descriptive analysis||||||0.001|||||||Chi-squared|||This comparison is specific to the incidence of tenderness at injection site.||||0.001
71072024|NCT03051516|141652754|OTHER|Descriptive analysis||||||0.004|||||||Chi-squared|||This comparison is specific to the incidence of swelling at injection site.||||0.004
70939922|NCT00936065|141380251|SUPERIORITY_OR_OTHER|||||||0.0493|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 24||||0.0493
70939923|NCT00936065|141380252|SUPERIORITY_OR_OTHER|||||||0.3112|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.3112
70939924|NCT00936065|141380252|SUPERIORITY_OR_OTHER|||||||0.0196|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0196
70939925|NCT00936065|141380252|SUPERIORITY_OR_OTHER|||||||0.0109|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0109
70939926|NCT00936065|141380252|SUPERIORITY_OR_OTHER|||||||0.0035|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0035
70939927|NCT00936065|141380252|SUPERIORITY_OR_OTHER|||||||0.0603|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.0603
70939928|NCT00936065|141380252|SUPERIORITY_OR_OTHER|||||||0.2184|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.2184
70939929|NCT00936065|141380253|SUPERIORITY_OR_OTHER|||||||0.1774|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.1774
70939930|NCT00936065|141380253|SUPERIORITY_OR_OTHER|||||||0.1195|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.1195
70939931|NCT00936065|141380253|SUPERIORITY_OR_OTHER|||||||0.0606|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0606
70939932|NCT00936065|141380253|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0030
70939933|NCT00936065|141380253|SUPERIORITY_OR_OTHER|||||||0.1567|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.1567
70939934|NCT00936065|141380253|SUPERIORITY_OR_OTHER|||||||0.2094|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.2094
70939935|NCT00936065|141380254|SUPERIORITY_OR_OTHER|||||||0.0302|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.0302
70939936|NCT00936065|141380254|SUPERIORITY_OR_OTHER|||||||0.098|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0980
70939937|NCT00936065|141380254|SUPERIORITY_OR_OTHER|||||||0.0711|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0711
70939938|NCT00936065|141380254|SUPERIORITY_OR_OTHER|||||||0.0077|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0077
70939939|NCT00936065|141380254|SUPERIORITY_OR_OTHER|||||||0.1553|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.1553
70939940|NCT00936065|141380254|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.0410
70939941|NCT00936065|141380255|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.0060
70939942|NCT00936065|141380255|SUPERIORITY_OR_OTHER|||||||0.0058|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0058
70939943|NCT00936065|141380255|SUPERIORITY_OR_OTHER|||||||0.0127|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0127
71072025|NCT03051516|141652754|OTHER|Descriptive analysis||||||0.133|||||||Chi-squared|||This comparison is specific to the incidence of medical attention/medication required.||||0.133
71072026|NCT03051516|141652755|SUPERIORITY|||||||0.93|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV16, in Arm I (Vaccine)||||0.93
71072027|NCT03051516|141652755|SUPERIORITY|||||||0.77|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV18, in Arm I (Vaccine)||||0.77
71072028|NCT03051516|141652755|SUPERIORITY|||||||0.57|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV31, in Arm I (Vaccine)||||0.57
71072029|NCT03051516|141652755|SUPERIORITY|||||||0.73|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV33, in Arm I (Vaccine)||||0.73
71072030|NCT03051516|141652755|SUPERIORITY|||||||0.998|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV45, in Arm I (Vaccine)||||0.998
71072031|NCT03051516|141652755|SUPERIORITY|||||||0.93|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV52, in Arm I (Vaccine)||||0.93
71072032|NCT03051516|141652755|SUPERIORITY|||||||0.95|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV58, in Arm I (Vaccine)||||0.95
71072033|NCT03051516|141652755|SUPERIORITY|||||||0.91|||||||Log Rank|||This p-value compares HSIL recurrence and presence of any HPV type, in Arm I (Vaccine)||||0.91
71072034|NCT03051516|141652755|SUPERIORITY|||||||0.22|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV16, in Arm II (Placebo)||||0.22
71114606|NCT01942668|141737372|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||0.98||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.5 mg / Progesterone 100 mg.||0.98||
71114607|NCT01942668|141737372|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||0.97||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.5 mg / Progesterone 50 mg.||0.97||
71114608|NCT01942668|141737372|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||1.09||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.25 mg / Progesterone 50 mg.||1.09||
71072035|NCT03051516|141652755|SUPERIORITY|||||||0.27|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV18, in Arm II (Placebo)||||0.27
71114609|NCT01942668|141737372|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||3.2||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Placebo.||3.20||
71072036|NCT03051516|141652755|SUPERIORITY|||||||0.72|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV31, in Arm II (Placebo)||||0.72
71072037|NCT03051516|141652755|SUPERIORITY|||||||0.71|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV33, in Arm II (Placebo)||||0.71
71114610|NCT01942668|141737373|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||1.06||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 1 mg / Progesterone 100 mg.||1.06||
71114611|NCT01942668|141737373|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||0.98||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.5 mg / Progesterone 100 mg.||0.98||
71114612|NCT01942668|141737373|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||0.97||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.5 mg / Progesterone 50 mg.||0.97||
71114613|NCT01942668|141737373|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||1.09||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.25 mg / Progesterone 50 mg.||1.09||
71072038|NCT03051516|141652755|SUPERIORITY|||||||0.11|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV45, in Arm II (Placebo)||||0.11
71072039|NCT03051516|141652755|SUPERIORITY|||||||0.58|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV52, in Arm II (Placebo)||||0.58
71072040|NCT03051516|141652755|SUPERIORITY|||||||0.81|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV58, in Arm II (Placebo)||||0.81
71072041|NCT03051516|141652755|SUPERIORITY|||||||0.73|||||||Log Rank|||This p-value compares HSIL recurrence and presence of any HPV type, in Arm II (Placebo)||||0.73
71072042|NCT00401544|141652756|SUPERIORITY_OR_OTHER||Percentage of participants|71.0||||||95.0|63.0|80.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||80|63|
71072043|NCT00401544|141652756|SUPERIORITY_OR_OTHER||Percentage of participants|63.0||||||95.0|54.0|72.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||72|54|
71072044|NCT00401544|141652757|SUPERIORITY_OR_OTHER||Percentage of participants|73.0||||||95.0|64.0|81.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||81|64|
71072045|NCT00401544|141652757|SUPERIORITY_OR_OTHER||Percentage of participants|62.0||||||95.0|54.0|71.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||71|54|
71072046|NCT00401544|141652762|SUPERIORITY_OR_OTHER||Percentage of participants|36.0||||||95.0|27.0|44.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||44|27|
71072047|NCT00401544|141652762|SUPERIORITY_OR_OTHER||Percentage of participants|38.0||||||95.0|29.0|47.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||47|29|
70939944|NCT00936065|141380255|SUPERIORITY_OR_OTHER|||||||0.0068|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0068
70939945|NCT00936065|141380255|SUPERIORITY_OR_OTHER|||||||0.0096|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.0096
70939946|NCT00936065|141380255|SUPERIORITY_OR_OTHER|||||||0.0132|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.0132
70939947|NCT00936065|141380256|SUPERIORITY_OR_OTHER|||||||0.6904|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.6904
70939948|NCT00936065|141380256|SUPERIORITY_OR_OTHER|||||||0.7021|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.7021
71072048|NCT00401544|141652763|SUPERIORITY_OR_OTHER||Percentage of participants|35.0||||||95.0|27.0|44.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||44|27|
71072049|NCT00401544|141652763|SUPERIORITY_OR_OTHER||Percentage of participants|39.0||||||95.0|30.0|47.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||47|30|
71072050|NCT00401544|141652764|SUPERIORITY_OR_OTHER||Percentage of participants|26.0||||||95.0|15.0|38.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||38|15|
71072051|NCT00401544|141652764|SUPERIORITY_OR_OTHER||Percentage of participants|31.0||||||95.0|19.0|42.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||42|19|
71072052|NCT00401544|141652764|SUPERIORITY_OR_OTHER||Percentage of participants|28.0||||||95.0|17.0|40.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||40|17|
71072053|NCT00401544|141652764|SUPERIORITY_OR_OTHER||Percentage of participants|25.0||||||95.0|14.0|36.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||36|14|
71072054|NCT00401544|141652765|SUPERIORITY_OR_OTHER||Percentage of participants|68.0||||||95.0|59.0|76.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||76|59|
71072055|NCT00401544|141652765|SUPERIORITY_OR_OTHER||Percentage of participants|59.0||||||95.0|50.0|68.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||68|50|
71072056|NCT00401544|141652766|SUPERIORITY_OR_OTHER||Percentage of participants|53.0||||||95.0|44.0|62.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||62|44|
71072057|NCT00401544|141652766|SUPERIORITY_OR_OTHER||Percentage of participants|74.0||||||95.0|66.0|82.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||82|66|
71072058|NCT02339155|141652775|NON_INFERIORITY|If the upper bound of the 90% confidence interval (CI) or the ratio of anti-PA Ab (attributable to AVA) GMCs between the AVA and the AVA + raxibacumab groups at Week 4 is less than 1.5, non-inferiority was to be established.|Ratio|1.18||||0.0016|TWO_SIDED|90.0|1.03|1.35|||t-test, 1 sided|||||1.35|1.03|0.0016
71114614|NCT01942668|141737373|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||3.2||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Placebo.||3.20||
71114615|NCT01942668|141737374|SUPERIORITY||Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|2.51||0.588|TWO_SIDED|95.0|-3.57|6.3||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||6.30|-3.57|0.588
70853147|NCT00955201|141194701|SUPERIORITY|||||||0.46|||||||ANOVA|||Comparison across groups at baseline.||||0.46
70939949|NCT00936065|141380256|SUPERIORITY_OR_OTHER|||||||0.2199|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.2199
70939950|NCT00936065|141380256|SUPERIORITY_OR_OTHER|||||||0.5071|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.5071
70939951|NCT00936065|141380256|SUPERIORITY_OR_OTHER|||||||0.4765|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.4765
70939952|NCT00936065|141380256|SUPERIORITY_OR_OTHER|||||||0.8662|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.8662
70939953|NCT00936065|141380257|SUPERIORITY_OR_OTHER|||||||0.1144|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.1144
70939954|NCT00936065|141380257|SUPERIORITY_OR_OTHER|||||||0.4509|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.4509
70939955|NCT00936065|141380257|SUPERIORITY_OR_OTHER|||||||0.435|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.4350
70939956|NCT00936065|141380257|SUPERIORITY_OR_OTHER|||||||0.6085|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.6085
70939957|NCT00936065|141380257|SUPERIORITY_OR_OTHER|||||||0.2582|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.2582
70939958|NCT00936065|141380257|SUPERIORITY_OR_OTHER|||||||0.549|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.5490
70939959|NCT00936065|141380258|SUPERIORITY_OR_OTHER|||||||0.3287|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.3287
70939960|NCT00936065|141380258|SUPERIORITY_OR_OTHER|||||||0.4149|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.4149
71072059|NCT02339155|141652776|OTHER||Ratio|1.09|||||TWO_SIDED|90.0|0.98|1.22|||t-test, 1 sided||Week 8|||1.22|0.98|
71072060|NCT02339155|141652776|OTHER||Ratio|0.98|||<|0.0001|TWO_SIDED|90.0|0.89|1.07|||t-test, 1 sided||Week 26|||1.07|0.89|<0.0001
71072061|NCT02634268|141652853|SUPERIORITY||Mean Difference (Final Values)|42.3||||0.02|TWO_SIDED|95.0|7.93|76.6|||Mixed Models Analysis|Difference in average six minute walk test distance at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month six minute walk test distance between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||76.6|7.93|.02
71072062|NCT02634268|141652854|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.0008|TWO_SIDED|95.0|-0.63|-0.09|||Mixed Models Analysis|Difference in average Modified Borg Scale score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month Modified Borg Scale score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||-0.09|-0.63|.0008
71072063|NCT02634268|141652855|SUPERIORITY||Mean Difference (Final Values)|-1.34||||0.0008|TWO_SIDED|95.0|-2.33|-0.34|||Mixed Models Analysis|Difference in average body weight at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month body weight between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||-0.34|-2.33|0.0008
71072064|NCT02634268|141652856|SUPERIORITY||Mean Difference (Final Values)|1.48||||0.01|TWO_SIDED|95.0|0.35|2.6|||Mixed Models Analysis|Difference in average SF-12 PCS at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month SF-12 PCS between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||2.60|0.35|0.01
71072065|NCT02634268|141652857|SUPERIORITY||Mean Difference (Final Values)|0.53||||0.45|TWO_SIDED|95.0|-0.84|1.89|||Mixed Models Analysis|Difference in average SF-12 MCS at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month SF-12 MCS between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||1.89|-0.84|0.45
71072066|NCT02634268|141652858|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.009|TWO_SIDED|95.0|-0.71|-0.1|||Mixed Models Analysis|Difference in average Framingham Risk Score at 12 months between control and intervention groups.||Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month Framingham Risk Score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||-0.10|-0.71|0.009
71072067|NCT02634268|141652859|SUPERIORITY||Mean Difference (Final Values)|-0.93||||0.13|TWO_SIDED|95.0|-2.12|0.26|||Mixed Models Analysis|Difference in average waist circumference at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12 month waist circumference between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||0.26|-2.12|0.13
71078653|NCT06010732|141665265|SUPERIORITY||Ratio of Means|5.77|||<|0.001|TWO_SIDED|95.0|4.86|6.85||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Placebo|analyzed as log(EFU)||6.85|4.86|<0.001
71078654|NCT06010732|141665265|SUPERIORITY||Ratio of Means|5.2|||<|0.001|TWO_SIDED|95.0|4.37|6.18||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Positive Control/Placebo|analyzed as log(EFU)||6.18|4.37|<0.001
71078655|NCT06010732|141665266|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.272|TWO_SIDED|95.0|-2.5|8.6||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Test-Positive Control|||8.6|-2.5|0.272
71078656|NCT06010732|141665266|SUPERIORITY||Mean Difference (Final Values)|34.8|||<|0.001|TWO_SIDED|95.0|29.3|40.3||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Test-Placebo|||40.3|29.3|<0.001
71114616|NCT01942668|141737374|SUPERIORITY||Mean Difference (Final Values)|1.29|STANDARD_ERROR_OF_MEAN|2.47||0.601|TWO_SIDED|95.0|-3.56|6.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||6.15|-3.56|0.601
71078657|NCT06010732|141665266|SUPERIORITY||Mean Difference (Final Values)|31.7|||<|0.001|TWO_SIDED|95.0|26.2|37.3||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Positive Control-Placebo|||37.3|26.2|<0.001
71078658|NCT06010732|141665267|SUPERIORITY||Ratio of Means|1.11||||0.191|TWO_SIDED|95.0|0.93|1.32||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Positive Control|analyzed as log(%CAR+100)||1.32|0.93|0.191
71078659|NCT06010732|141665267|SUPERIORITY||Ratio of Means|0.94||||0.003|TWO_SIDED|95.0|0.91|0.98||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Placebo|analyzed as log(%CAR+100)||0.98|0.91|0.003
71072068|NCT02634268|141652860|SUPERIORITY||Mean Difference (Final Values)|-0.59||||0.64|TWO_SIDED|95.0|-3.02|1.84|||Mixed Models Analysis|Difference in average 12 month systolic blood at 12 months between control and intervention groups|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month systolic blood pressure between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||1.84|-3.02|0.64
71072069|NCT02634268|141652861|SUPERIORITY||Mean Difference (Final Values)|-0.51||||0.004|TWO_SIDED|95.0|-0.85|-0.17|||Mixed Models Analysis|Difference in average BMI at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month BMI between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||-0.17|-0.85|0.004
71072070|NCT02634268|141652862|SUPERIORITY||Mean Difference (Final Values)|-2.25||||0.09|TWO_SIDED|95.0|-4.87|0.36|||Mixed Models Analysis|Difference in average SGRQ-C Symptom score at 12 months between control and intervention groups.||Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12 month SGRQ-C Symptom score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|0.36|-4.87|0.09
71072071|NCT02634268|141652863|SUPERIORITY||Mean Difference (Final Values)|-2.31||||0.12|TWO_SIDED|95.0|-5.19|0.56|||Mixed Models Analysis|Difference in average SGRQ-C Activity score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12 month SGRQ-C Activity score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||0.56|-5.19|0.12
71072072|NCT02634268|141652864|SUPERIORITY||Mean Difference (Final Values)|-2.72||||0.03|TWO_SIDED|95.0|-5.19|-0.25|||Mixed Models Analysis|Difference in average SGRQ-C Impact score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12 month SGRQ-C Impact score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||-0.25|-5.19|0.03
71072073|NCT02634268|141652865|SUPERIORITY||Mean Difference (Final Values)|-2.42||||0.03|TWO_SIDED|95.0|-4.55|-0.28|||Mixed Models Analysis|Difference in average SGRQ-C Total score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month SGRQ-C Total score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||-0.28|-4.55|0.03
71072074|NCT00805870|141652866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.271|STANDARD_ERROR_OF_MEAN|26.298|>|0.05|TWO_SIDED|95.0|-63.521|46.978|||ANOVA|||Null hypothesis is that no difference is observed in quadriceps muscle strength between the fish oil and control groups.||46.978|-63.521|>0.05
71072075|NCT00805870|141652867|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.845|STANDARD_ERROR_OF_MEAN|1.417|>|0.05|TWO_SIDED|95.0|-4.823|1.132|||ANOVA|||Null hypothesis is that there is no difference in the amount of force applied to the quadriceps to elicit pain or discomfort between the fish oil and control groups.||1.132|-4.823|>0.05
71072076|NCT00805870|141652868|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-57.015|STANDARD_ERROR_OF_MEAN|47.093|>|0.05|TWO_SIDED|95.0|-156.373|42.344|||ANOVA|||Null hypothesis is that there is no difference in creatine kinase activity between the fish oil and the control groups.||42.344|-156.373|>0.05
71114617|NCT01942668|141737374|SUPERIORITY||Mean Difference (Final Values)|3.17|STANDARD_ERROR_OF_MEAN|2.49||0.202|TWO_SIDED|95.0|-1.71|8.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||8.06|-1.71|0.202
71114618|NCT01942668|141737374|SUPERIORITY||Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|2.46||0.431|TWO_SIDED|95.0|-6.76|2.89||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||2.89|-6.76|0.431
71114619|NCT01942668|141737375|SUPERIORITY||Mean Difference (Final Values)|-4.35|STANDARD_ERROR_OF_MEAN|3.05||0.154|TWO_SIDED|95.0|-10.34|1.64||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||1.64|-10.34|0.154
71114620|NCT01942668|141737375|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|3.0||0.956|TWO_SIDED|95.0|-6.06|5.73||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||5.73|-6.06|0.956
71114621|NCT01942668|141737375|SUPERIORITY||Mean Difference (Final Values)|3.54|STANDARD_ERROR_OF_MEAN|3.01||0.24|TWO_SIDED|95.0|-2.37|9.46||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||9.46|-2.37|0.240
70939961|NCT00936065|141380258|SUPERIORITY_OR_OTHER|||||||0.3837|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.3837
70853148|NCT00955201|141194701|SUPERIORITY|||||||0.72|||||||ANOVA|||Comparison across groups at 12 wks.||||0.72
70939962|NCT00936065|141380258|SUPERIORITY_OR_OTHER|||||||0.6777|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.6777
70939963|NCT00936065|141380258|SUPERIORITY_OR_OTHER|||||||0.4976|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.4976
70939964|NCT00936065|141380258|SUPERIORITY_OR_OTHER|||||||0.4189|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.4189
70939965|NCT00936065|141380259|SUPERIORITY_OR_OTHER|||||||0.476|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.4760
70939966|NCT00936065|141380259|SUPERIORITY_OR_OTHER|||||||0.404|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.4040
70939967|NCT00936065|141380259|SUPERIORITY_OR_OTHER|||||||0.4753|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.4753
70939968|NCT00936065|141380259|SUPERIORITY_OR_OTHER|||||||0.5084|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.5084
70939969|NCT00936065|141380259|SUPERIORITY_OR_OTHER|||||||0.2293|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.2293
71072077|NCT00805870|141652869|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.022|STANDARD_ERROR_OF_MEAN|0.188|>|0.05|TWO_SIDED|95.0|-0.374|0.417|||ANOVA|||The null hypothesis is that there is no difference in interleukin-6 concentration between the fish oil and control groups.||0.417|-0.374|>0.05
71072078|NCT00454818|141652905|SUPERIORITY_OR_OTHER|||||||0.078||||||The a priori threshold for statistical significance was P \< 0.2. There were no adjustments for multiple comparisons.|t-test, 2 sided|||||||0.078
71072079|NCT00454818|141652905|SUPERIORITY_OR_OTHER|||||||0.515||||||The a priori threshold for statistical significance was P \< 0.2. There were no adjustments for multiple comparisons.|t-test, 2 sided|||||||0.515
71072080|NCT00454818|141652905|SUPERIORITY_OR_OTHER|||||||0.098||||||The a priori threshold for statistical significance was P \< 0.2. There were no adjustments for multiple comparisons.|t-test, 2 sided|||||||0.098
71072081|NCT00767039|141652923|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||Tested null hypothesis. T-test and Generalized Linear Model was used to assess respiratory support parameters (mean airway pressure and percent fraction of inspiratory oxygen x mean airway pressure).|t-test, 2 sided|||Respiratory support were compared using a t-test for individual time points and Generalized Linear Model to account for correlations among repeated measures. Patient who survive \>/= 3 days were included in the analysis.||||< 0.05
71072082|NCT00767039|141652924|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.43|||<|0.05|TWO_SIDED|95.0|0.19|0.95|||Mantel Haenszel|||||0.95|0.19|<0.05
71072083|NCT00767039|141652925|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Tested null hypothesis. T-test and Generalized Linear Model was used to assess respiratory support parameters (mean airway pressure and percent fraction of inspiratory oxygen x mean airway pressure).||||<0.05
71072084|NCT00767039|141652926|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49|||<|0.05|TWO_SIDED|95.0|0.25|0.96|||Mantel Haenszel|||||0.96|0.25|<0.05
71072085|NCT00767039|141652927|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.38|||<|0.01|TWO_SIDED|95.0|1.29|4.38|||Mantel Haenszel|||||4.38|1.29|<0.01
71072086|NCT00767039|141652928|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||||||>0.05
71072087|NCT00767039|141652929|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Tested null hypothesis. T-test and Generalized Linear Model was used to assess respiratory support parameters (mean airway pressure and percent fraction of inspiratory oxygen x mean airway pressure).||||<0.05
71072088|NCT00767039|141652930|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Tested null hypothesis. T-test and Generalized Linear Model was used to assess respiratory support parameters (mean airway pressure and percent fraction of inspiratory oxygen x mean airway pressure).||||<0.05
71072089|NCT00767039|141652931|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.01
71072090|NCT00767039|141652932|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.44|||>|0.05|TWO_SIDED|95.0|0.71|2.89|||Mantel Haenszel|||||2.89|0.71|>0.05
70853149|NCT00955201|141194701|SUPERIORITY|||||||0.22|||||||ANOVA|||Comparison across groups at 24wks.||||0.22
70853150|NCT00955201|141194702|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.98
70939970|NCT00936065|141380259|SUPERIORITY_OR_OTHER|||||||0.3822|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.3822
70939971|NCT00936065|141380260|SUPERIORITY_OR_OTHER|||||||0.2691|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.2691
70939972|NCT00936065|141380260|SUPERIORITY_OR_OTHER|||||||0.0142|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0142
70939973|NCT00936065|141380260|SUPERIORITY_OR_OTHER|||||||0.0383|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0383
70939974|NCT00936065|141380260|SUPERIORITY_OR_OTHER|||||||0.0026|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0026
70939975|NCT00936065|141380260|SUPERIORITY_OR_OTHER|||||||0.0475|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.0475
70939976|NCT00936065|141380260|SUPERIORITY_OR_OTHER|||||||0.0205|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.0205
70939977|NCT00936065|141380261|SUPERIORITY_OR_OTHER|||||||0.0512|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.0512
70939978|NCT00936065|141380261|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0024
70939979|NCT00936065|141380261|SUPERIORITY_OR_OTHER|||||||0.0946|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0946
71072091|NCT00767039|141652933|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.48|||>|0.05|TWO_SIDED|90.0|0.84|2.63|||Mantel Haenszel|||||2.63|0.84|>0.05
71072092|NCT01472757|141652949|SUPERIORITY|||||||0.013|||||||ANCOVA|||||||0.013
71072093|NCT01472757|141652949|SUPERIORITY||||||<|0.001||||||Calculated p-value was less than 0.001.|ANCOVA|||||||<0.001
71072094|NCT01472757|141652949|SUPERIORITY||||||<|0.001||||||Calculated p-value was less than 0.001.|ANCOVA|||||||<0.001
71072095|NCT01472757|141652950|SUPERIORITY|||||||0.001|||||||Fisher Exact|||||||0.001
71072096|NCT01472757|141652950|SUPERIORITY|||||||0.006|||||||Fisher Exact|||||||0.006
71072097|NCT01472757|141652950|SUPERIORITY|||||||0.011|||||||Fisher Exact|||||||0.011
71072098|NCT01472757|141652951|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
71072099|NCT01472757|141652951|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
71072100|NCT01472757|141652951|SUPERIORITY|||||||0.008|||||||ANCOVA|||||||0.008
71072101|NCT02961062|141652972|SUPERIORITY||Mean Difference (Final Values)|-11.1|STANDARD_ERROR_OF_MEAN|0.0||0.005|TWO_SIDED|90.0|-17.54|-4.71|||Kenward-Roger method|||||-4.71|-17.54|0.005
71072102|NCT02961062|141652973|SUPERIORITY||Median Difference (Final Values)|-8.56|STANDARD_ERROR_OF_MEAN|3.37||0.017|TWO_SIDED|90.0|-14.29|-2.83|||Kenward-Roger method|||||-2.83|-14.29|0.017
71072103|NCT01777568|141653005|SUPERIORITY||Risk Ratio (RR)|0.99||||0.85|TWO_SIDED|95.0|0.85|1.14|||GEE model||Relative Risk: 80% (numerator) vs. 30% (denominator)|||1.14|0.85|0.85
71072104|NCT01777568|141653006|SUPERIORITY||Risk Ratio (RR)|0.8||||0.047|TWO_SIDED|95.0|0.66|1.01|||Chi-squared|||||1.01|0.66|0.047
71072105|NCT00844480|141653007|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||.03
71072106|NCT02858180|141653010|OTHER||Proportion|86.7|||||TWO_SIDED|95.0|59.5|98.3||||||||98.3|59.5|
71072107|NCT01005888|141653014|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Observed number of attacks.|ANOVA|||||||<0.0001
71072108|NCT01005888|141653014|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Normalized number of attacks.|ANOVA|||||||<0.0001
71072109|NCT01005888|141653015|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999||95.0||||Period 1.|Fisher Exact|||||||>0.999
71072110|NCT01005888|141653015|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999||95.0||||Period 2.|Fisher Exact|||||||>0.999
71072111|NCT01005888|141653016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0008
71114622|NCT01942668|141737375|SUPERIORITY||Mean Difference (Final Values)|-2.77|STANDARD_ERROR_OF_MEAN|2.98||0.353|TWO_SIDED|95.0|-8.62|3.08||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||3.08|-8.62|0.353
70939980|NCT00936065|141380261|SUPERIORITY_OR_OTHER|||||||0.0935|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0935
71072112|NCT01005888|141653017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0004
71072113|NCT01005888|141653018|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71072114|NCT01005888|141653019|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71072115|NCT01005888|141653020|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Visit 1 change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
71072116|NCT01005888|141653020|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Week 4 change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
71072117|NCT01005888|141653020|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0||||Week 8 change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.0001
71072118|NCT01005888|141653020|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0028||95.0||||Week 12 change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.0028
71072119|NCT01005888|141653021|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Visit 1 percent change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
71072120|NCT01005888|141653021|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Week 4 percent change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
71072121|NCT01005888|141653021|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Week 8 percent change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
70939981|NCT00936065|141380261|SUPERIORITY_OR_OTHER|||||||0.2073|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.2073
70939982|NCT00936065|141380261|SUPERIORITY_OR_OTHER|||||||0.3415|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.3415
71072122|NCT01005888|141653021|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0||||Week 12 percent change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.0002
71072123|NCT01043705|141653022|SUPERIORITY_OR_OTHER||One sided Fisher's exact test.|0.0044||||0.0023|ONE_SIDED|95.0||0.009|||Fisher Exact|||||0.009||0.0023
71072124|NCT01043705|141653022|SUPERIORITY_OR_OTHER||1-sided Fisher's Exact Text|0.002||||0.0052|ONE_SIDED|95.0||0.01|||Fisher Exact|||||0.01||0.0052
71072125|NCT01043705|141653022|SUPERIORITY_OR_OTHER||1-sided Fisher's Exact Test|0.006||||0.0176|ONE_SIDED|95.0||0.014|||Fisher Exact|||||0.014||0.0176
71072126|NCT01043705|141653022|SUPERIORITY_OR_OTHER||Fisher's Exact Test|0.7||||0.3764|TWO_SIDED|95.0|||||Fisher Exact|||||||0.3764
71072127|NCT01043705|141653023|SUPERIORITY_OR_OTHER||Rate compared to performance goal|4.4||||0.0005|TWO_SIDED|95.0|3.3|5.8|||1-sided Chi-square|||||5.8|3.3|0.0005
71072128|NCT01043705|141653023|SUPERIORITY_OR_OTHER||Rate compared to a performance goal|3.1||||0.0444|TWO_SIDED|95.0|1.7|5.1|||1-sided Chi-square test|||||5.1|1.7|0.0444
71072129|NCT01043705|141653023|SUPERIORITY_OR_OTHER||rate compared to performance goal|5.4||||0.0006|TWO_SIDED|95.0|3.8|5.4|||1-sided Chi-squared test|||All types of mechanical complications combined.||5.4|3.8|0.0006
71072130|NCT01043705|141653023|SUPERIORITY_OR_OTHER||Descriptive|5.4||||0.0745|TWO_SIDED|95.0|3.7|7.5|||Chi-squared|||All mechanical complications, retrospective, non-TYRX cohort||7.5|3.7|0.0745
71072131|NCT01623037|141653028|OTHER||sucess proportion|71.1|||||TWO_SIDED|95.0|55.7|83.6||||||||83.6|55.7|
71072132|NCT00347919|141653064|SUPERIORITY_OR_OTHER||Percentage difference|2.7||||0.3724||90.0|-11.0|16.3|||Chi-squared||Difference in the percentage of independently-evaluated PD between lapatinib and combination therapy (lapatinib plus pazopanib)|||16.3|-11.0|0.3724
71072133|NCT00347919|141653064|SUPERIORITY_OR_OTHER||Percentage difference|5.4||||0.2578||90.0|-8.4|19.2|||Chi-squared||Difference in the percentage of investigator-evaluated PD between lapatinib and combination therapy (lapatinib plus pazopanib)|||19.2|-8.4|0.2578
71072134|NCT00347919|141653065|SUPERIORITY_OR_OTHER|||||||0.7488||95.0|||||Log Rank|||||||0.7488
71072135|NCT03379753|141653070|OTHER||U statistic|984.5||||0.57|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.57
71072136|NCT01032239|141653071|SUPERIORITY||Hodges-Lehmann|-0.667||||0.014|TWO_SIDED|95.1|-1.0|-0.1667|||Wilcoxon (Mann-Whitney)|||To test the null hypothesis the sample size needed was 44 evaluable patient (22 per arm) with a power of 80 %.||-0.1667|-1.000|0.0140
71072137|NCT01032239|141653072|SUPERIORITY||Hodges-Lehmann|-0.6||||0.0042|TWO_SIDED|95.0|-1.0|-0.2|||Wilcoxon (Mann-Whitney)|||||-0.2000|-1.0000|0.0042
71072138|NCT01032239|141653073|SUPERIORITY|||||||0.054|||||||Wilcoxon (Mann-Whitney)|||||||0.0540
71072139|NCT01032239|141653074|SUPERIORITY|||||||0.6256|||||||Wilcoxon (Mann-Whitney)|||||||0.6256
71072140|NCT01032239|141653075|SUPERIORITY|||||||0.3676|||||||Cochran-Mantel-Haenszel|||||||0.3676
71072141|NCT01032239|141653076|SUPERIORITY|||||||0.038|||||||Wilcoxon (Mann-Whitney)|||Actual Pain||||0.0380
71072142|NCT01032239|141653076|SUPERIORITY|||||||0.0136|||||||Wilcoxon (Mann-Whitney)|||Least Pain||||0.0136
71072143|NCT01032239|141653076|SUPERIORITY|||||||0.2427|||||||Wilcoxon (Mann-Whitney)|||Worst Pain||||0.2427
70939983|NCT00936065|141380262|SUPERIORITY_OR_OTHER|||||||0.0202|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.0202
71072144|NCT01032239|141653077|SUPERIORITY|||||||0.7661|||||||Fisher Exact|||||||0.7661
71072145|NCT01032239|141653078|SUPERIORITY|||||||0.0197|||||||Wilcoxon (Mann-Whitney)|||Utility Score||||0.0197
71072146|NCT01032239|141653078|SUPERIORITY|||||||0.3807|||||||t-test, 2 sided|||VAS||||0.3807
71072147|NCT01032239|141653079|SUPERIORITY|||||||0.1068|||||||t-test, 2 sided|||PCS||||0.1068
71072148|NCT01032239|141653079|SUPERIORITY|||||||0.6824|||||||t-test, 2 sided|||MCS||||0.6824
71072149|NCT01032239|141653080|SUPERIORITY|||||||0.2105|||||||t-test, 2 sided|||||||0.2105
71072150|NCT02426749|141653110|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71072151|NCT02407132|141653132|SUPERIORITY|||||||0.038||||||The p-value above reflects results of between-arms analysis of mean change in HbA1c from baseline to immediate post-intervention. 6 months between-arms p-value = 0.139; 12 months between-arms p-value = 0.013. Analyses do not include imputed values.|Linear mixed effects regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||The outcome variable for these analyses is Change in mean HbA1c from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention.||||0.038
71072152|NCT02407132|141653133|SUPERIORITY|||||||0.234||||||The p-value above reflects results of between-arms analysis of change in mean BMI from baseline to immediate post-intervention. 6 months between-arms p-value = 0.552; 12 months between-arms p-value = 0.447. Analyses do not include imputed values.|Linear mixed effects regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||The outcome variable for these analyses is Change in mean BMI from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention.||||0.234
71072153|NCT02407132|141653134|SUPERIORITY|||||||0.019||||||The p-value above reflects results of between-arms analysis of change in mean total chol from baseline to immediate post-intervention. 6 months between-arms p-value=0.598; 12 months between-arms p-value=0.073. Analyses do not include imputed values.|Linear mixed effects regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||The outcome variable for these analyses is Change in mean Total Cholesterol (mg/dL) from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention.||||0.019
71114623|NCT01942668|141737376|SUPERIORITY||Mean Difference (Final Values)|-8.56|STANDARD_ERROR_OF_MEAN|3.16||0.007|TWO_SIDED|95.0|-14.75|-2.36||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-2.36|-14.75|0.007
71072154|NCT02407132|141653135|SUPERIORITY|||||||0.186||||||The p-value above reflects results of between-arms analysis of mean change in HDL from baseline to immediate post-intervention. 6 months between-arms p-value=0.009; 12 months between-arms p-value=0.201. Analyses do not include imputed values.|Linear mixed effects regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||The outcome variable for these analyses is Change in mean HDL (mg/dL) from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention.||||0.186
71072155|NCT02407132|141653136|SUPERIORITY|||||||0.04||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed effects logistic regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.||||0.040
71072156|NCT02407132|141653137|SUPERIORITY|||||||0.312||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed Effects Logistic Regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.||||0.312
71072157|NCT02407132|141653138|SUPERIORITY|||||||0.622||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed effects logistic regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.||||0.622
71072158|NCT02407132|141653139|SUPERIORITY|||||||0.957||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed effects logistic regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.||||0.957
71072159|NCT02407132|141653140|SUPERIORITY|||||||0.147||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed effects logistic regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.||||0.147
71114624|NCT01942668|141737376|SUPERIORITY||Mean Difference (Final Values)|-3.76|STANDARD_ERROR_OF_MEAN|3.11||0.227|TWO_SIDED|95.0|-9.86|2.35||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||2.35|-9.86|0.227
70939984|NCT00936065|141380262|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0090
70939985|NCT00936065|141380262|SUPERIORITY_OR_OTHER|||||||0.0742|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0742
70939986|NCT00936065|141380262|SUPERIORITY_OR_OTHER|||||||0.0445|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0445
71114625|NCT01942668|141737376|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|3.12||0.597|TWO_SIDED|95.0|-7.77|4.47||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||4.47|-7.77|0.597
70939987|NCT00936065|141380262|SUPERIORITY_OR_OTHER|||||||0.2211|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.2211
70939988|NCT00936065|141380262|SUPERIORITY_OR_OTHER|||||||0.1982|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.1982
70939989|NCT00936065|141380263|SUPERIORITY_OR_OTHER|||||||0.0409|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.0409
70939990|NCT00936065|141380263|SUPERIORITY_OR_OTHER|||||||0.145|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.1450
70939991|NCT00936065|141380263|SUPERIORITY_OR_OTHER|||||||0.201|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.2010
71072160|NCT02407132|141653141|SUPERIORITY|||||||0.326||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed effects logistic regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.||||0.326
71072161|NCT03617861|141653145|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Healthy Controls Secretin vs Healthy Controls Placebo||||0.12
71072162|NCT03617861|141653145|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.65
71114626|NCT01942668|141737376|SUPERIORITY||Mean Difference (Final Values)|-7.24|STANDARD_ERROR_OF_MEAN|3.08||0.019|TWO_SIDED|95.0|-13.28|-1.19||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-1.19|-13.28|0.019
70939992|NCT00936065|141380263|SUPERIORITY_OR_OTHER|||||||0.0424|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0424
71072163|NCT03617861|141653145|SUPERIORITY|||||||0.0574|||||||ANCOVA|||Healthy Controls vs Functional Dyspepsia||||0.0574
70939993|NCT00936065|141380263|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.0090
70939994|NCT00936065|141380263|SUPERIORITY_OR_OTHER|||||||0.0116|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.0116
70939995|NCT00936065|141380264|SUPERIORITY_OR_OTHER|||||||0.3355|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.3355
70939996|NCT00936065|141380264|SUPERIORITY_OR_OTHER|||||||0.0341|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0341
70939997|NCT00936065|141380264|SUPERIORITY_OR_OTHER|||||||0.0899|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0899
70939998|NCT00936065|141380264|SUPERIORITY_OR_OTHER|||||||0.0062|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0062
70939999|NCT00936065|141380264|SUPERIORITY_OR_OTHER|||||||0.1241|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.1241
70940000|NCT00936065|141380264|SUPERIORITY_OR_OTHER|||||||0.0393|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.0393
70940001|NCT00936065|141380265|SUPERIORITY_OR_OTHER|||||||0.3402|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.3402
70940002|NCT00936065|141380265|SUPERIORITY_OR_OTHER|||||||0.1184|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.1184
70940003|NCT00936065|141380265|SUPERIORITY_OR_OTHER|||||||0.0104|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0104
71072164|NCT03617861|141653146|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||Healthy Controls Secretin vs Healthy Controls Placebo||||0.85
71114627|NCT01942668|141737377|SUPERIORITY||Mean Difference (Final Values)|-12.81|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-19.29|-6.32||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.32|-19.29|<0.001
70940004|NCT00936065|141380265|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0010
70940005|NCT00936065|141380265|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.0250
70940006|NCT00936065|141380265|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.0410
70940007|NCT00936065|141380266|SUPERIORITY_OR_OTHER|||||||0.0894|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.0894
70940008|NCT00936065|141380266|SUPERIORITY_OR_OTHER|||||||0.0084|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0084
70940009|NCT00936065|141380266|SUPERIORITY_OR_OTHER|||||||0.0727|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0727
70940010|NCT00936065|141380266|SUPERIORITY_OR_OTHER|||||||0.0337|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0337
70940011|NCT00936065|141380266|SUPERIORITY_OR_OTHER|||||||0.138|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.1380
70940012|NCT00936065|141380266|SUPERIORITY_OR_OTHER|||||||0.3415|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.3415
70940013|NCT00936065|141380267|SUPERIORITY_OR_OTHER|||||||0.4407|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.4407
70940014|NCT00936065|141380267|SUPERIORITY_OR_OTHER|||||||0.1768|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.1768
70940015|NCT00936065|141380267|SUPERIORITY_OR_OTHER|||||||0.4636|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.4636
71072165|NCT03617861|141653146|SUPERIORITY|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.82
71072166|NCT03617861|141653146|SUPERIORITY|||||||0.1451|||||||ANCOVA|||Healthy Controls vs Functional Dyspepsia||||0.1451
71072167|NCT03617861|141653147|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||Healthy Controls Secretin vs Healthy Controls Placebo||||0.85
71072168|NCT03617861|141653147|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||1.0
70940016|NCT00936065|141380267|SUPERIORITY_OR_OTHER|||||||0.334|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.3340
70940017|NCT00936065|141380267|SUPERIORITY_OR_OTHER|||||||0.1785|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.1785
70940018|NCT00936065|141380267|SUPERIORITY_OR_OTHER|||||||0.7428|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.7428
70940019|NCT00936065|141380268|SUPERIORITY_OR_OTHER|||||||0.5377|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Baseline||||0.5377
70940020|NCT00936065|141380268|SUPERIORITY_OR_OTHER|||||||0.1419|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 2||||0.1419
70940021|NCT00936065|141380268|SUPERIORITY_OR_OTHER|||||||0.5391|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 4||||0.5391
70940022|NCT00936065|141380268|SUPERIORITY_OR_OTHER|||||||0.2589|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 8||||0.2589
70940023|NCT00936065|141380268|SUPERIORITY_OR_OTHER|||||||0.0635|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 12||||0.0635
70940024|NCT00936065|141380268|SUPERIORITY_OR_OTHER|||||||0.1172|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 18||||0.1172
70940025|NCT00936065|141380268|SUPERIORITY_OR_OTHER|||||||0.1247|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 24||||0.1247
70940026|NCT00936065|141380269|SUPERIORITY_OR_OTHER|||||||0.9429|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Baseline||||0.9429
70940027|NCT00936065|141380269|SUPERIORITY_OR_OTHER|||||||0.0927|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 2||||0.0927
70940028|NCT00936065|141380269|SUPERIORITY_OR_OTHER|||||||0.0151|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 4||||0.0151
71072169|NCT03617861|141653147|SUPERIORITY|||||||0.4233|||||||ANCOVA|||Healthy Controls vs Functional Dyspepsia||||0.4233
70853151|NCT00955201|141194702|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.99
70940029|NCT00936065|141380269|SUPERIORITY_OR_OTHER|||||||0.1124|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 8||||0.1124
70940030|NCT00936065|141380269|SUPERIORITY_OR_OTHER|||||||0.0242|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 12||||0.0242
70940031|NCT00936065|141380269|SUPERIORITY_OR_OTHER|||||||0.0237|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 18||||0.0237
70940032|NCT00936065|141380269|SUPERIORITY_OR_OTHER|||||||0.0176|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 24||||0.0176
71072170|NCT03617861|141653148|SUPERIORITY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||Healthy Controls Secretin vs Healthy Controls Placebo||||0.92
70853152|NCT00955201|141194702|SUPERIORITY|||||||0.87||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.87
70940033|NCT01885559|141380279|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.08||||0.58|TWO_SIDED|95.0|0.82|1.42|||Regression, Cox|Analyses were adjusted for age, sex, race, baseline estimated Glomerular Filtration Rate (eGFR) and clinical site|ACE+ARB (Lisinopril-telmisartan) compared to ACE+placebo (Lisinopril-placebo)|||1.42|0.82|0.58
70940034|NCT01885559|141380280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.88|TWO_SIDED|95.0|-3.2|2.8|||shared parameter model|shared parameter models used due to informative censoring that occurred when patients did not have secondary outcomes measured after reaching endpoint||||2.8|-3.2|0.88
70940035|NCT01885559|141380281|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.7||||0.17|TWO_SIDED|95.0|-3.9|0.7||controlling for age, sex, race, and clinical site|Mixed Models Analysis||ACE-I+ARB annual percent change minus ACE-I + placebo annual percent change|||0.7|-3.9|0.17
70940036|NCT01885559|141380282|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.03||||0.85|TWO_SIDED|95.0|0.8|1.32|||Regression, Cox|adjusting for age, sex, race, and clinical site and recurrent events|Hazard ratio compares ACE-I + ARB compared to ACE-I + placebo|||1.32|0.80|0.85
70940037|NCT01885559|141380283|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.57|TWO_SIDED|95.0|0.42|1.6|||Regression, Cox|adjusting for age, sex, race, and clinical site and accounting for recurrent events|Hazard ratio is comparing ACE-I + ARB to ACE-I + placebo|||1.6|0.42|0.57
70940038|NCT01885559|141380284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.032||||0.75|TWO_SIDED|95.0|-0.23|0.16|||shared parameter model|Shared parameter models were used due to informed censoring when patients who reached the primary endpoint were no longer assessed on the measure.||||0.16|-0.23|0.75
70940039|NCT01885559|141380285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.047||||0.66|TWO_SIDED|95.0|-0.26|0.16|||shared parameter model|Shared parameter models were used due to the informative censoring when patients who reached endpoint were not longer assessed on this measure.||||0.16|-0.26|0.66
70940040|NCT01885559|141380286|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0||||0.64|TWO_SIDED|95.0|0.99|1.01|||Mixed Models Analysis|Generalized linear mixed models are used with a logit link. Model controlled for baseline age, sex, race, and clinical site.|"Odds ratio represents the multiplicative effect of ACE-I + ARB group compared to the ACE-I + placebo group in change in pain over time.~ACE-I + ARB OR per month was 1.01 (1.00, 1.01) and ACE-I + placebo OR was 1.01 (1.01, 1.01)."|||1.01|0.99|0.64
70940041|NCT02680145|141380288|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Baseline score vs Follow-up score||||0.001
71072171|NCT03617861|141653148|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||1.0
70853153|NCT00955201|141194702|SUPERIORITY|||||||0.95||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.95
70853154|NCT00955201|141194702|SUPERIORITY|||||||0.39|||||||ANOVA|||Comparison across groups at baseline.||||0.39
70853155|NCT00955201|141194702|SUPERIORITY|||||||0.59|||||||ANOVA|||Comparison across groups at 12-wks.||||0.59
71072172|NCT03617861|141653148|SUPERIORITY|||||||0.3891|||||||ANCOVA|||Healthy Controls vs Functional Dyspepsia||||0.3891
71072173|NCT03617861|141653149|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Healthy Secretin vs Healthy Placebo||||0.004
71072174|NCT03617861|141653149|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.03
71072175|NCT03617861|141653149|SUPERIORITY|||||||0.0355|||||||ANCOVA|||Healthy vs Functional Dyspepsia||||0.0355
71072176|NCT03617861|141653150|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Nausea: Healthy Controls Secretin vs Healthy Controls Placebo||||0.5
70940042|NCT02680145|141380289|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Baseline score vs Follow-up score||||0.001
70940043|NCT02680145|141380290|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||Baseline score vs Follow-up score||||0.005
70940044|NCT01542502|141380291|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||ANOVA|||||||0.009
71072177|NCT03617861|141653150|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Nausea: Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.16
71072178|NCT03617861|141653150|SUPERIORITY|||||||0.0016|||||||ANCOVA|||Nausea: Healthy Controls vs Functional Dyspepsia||||0.0016
71072179|NCT03617861|141653150|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Fullness: Healthy Controls Secretin vs Healthy Controls Placebo||||0.10
71072180|NCT03617861|141653150|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Fullness: Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.30
71072181|NCT03617861|141653150|SUPERIORITY|||||||0.0002|||||||ANCOVA|||Fullness: Healthy Controls vs Functional Dyspepsia||||0.0002
71072182|NCT03617861|141653150|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Bloating: Healthy Controls Secretin vs Healthy Controls Placebo||||0.41
71114628|NCT01942668|141737377|SUPERIORITY||Mean Difference (Final Values)|-8.07|STANDARD_ERROR_OF_MEAN|3.25||0.013|TWO_SIDED|95.0|-14.46|-1.68||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-1.68|-14.46|0.013
71114629|NCT01942668|141737377|SUPERIORITY||Mean Difference (Final Values)|-4.81|STANDARD_ERROR_OF_MEAN|3.26||0.141|TWO_SIDED|95.0|-11.21|1.59||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||1.59|-11.21|0.141
70940045|NCT01542502|141380292|SUPERIORITY_OR_OTHER|||||||0.87|||||||ANOVA|||||||0.87
70940046|NCT01052714|141380298|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
70940047|NCT01052714|141380299|SUPERIORITY|||||||0.718|||||||Mixed Models Analysis|||||||0.718
71072183|NCT03617861|141653150|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Bloating Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.67
71072184|NCT03617861|141653150|SUPERIORITY|||||||0.033|||||||ANCOVA|||Bloating: Healthy Controls vs Functional Dyspepsia||||0.0330
70940048|NCT01052714|141380300|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
70940049|NCT01052714|141380301|SUPERIORITY|||||||0.676|||||||Mixed Models Analysis|||||||0.676
70940050|NCT01052714|141380302|SUPERIORITY|||||||0.141|||||||Mixed Models Analysis|||||||0.141
70940051|NCT01052714|141380303|SUPERIORITY|||||||0.92|||||||Mixed Models Analysis|||||||0.92
71114630|NCT01942668|141737377|SUPERIORITY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|3.22||0.001|TWO_SIDED|95.0|-16.73|-4.08||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.08|-16.73|0.001
71114631|NCT01942668|141737378|SUPERIORITY||Mean Difference (Final Values)|-15.59|STANDARD_ERROR_OF_MEAN|3.35|<|0.001|TWO_SIDED|95.0|-22.16|-9.02||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-9.02|-22.16|<0.001
71114632|NCT01942668|141737378|SUPERIORITY||Mean Difference (Final Values)|-9.88|STANDARD_ERROR_OF_MEAN|3.29||0.003|TWO_SIDED|95.0|-16.34|-3.41||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-3.41|-16.34|0.003
71114633|NCT01942668|141737378|SUPERIORITY||Mean Difference (Final Values)|-5.9|STANDARD_ERROR_OF_MEAN|3.31||0.075|TWO_SIDED|95.0|-12.4|0.59||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.59|-12.40|0.075
70940052|NCT01052714|141380304|SUPERIORITY|||||||0.322|||||||Mixed Models Analysis|||||||0.322
70940053|NCT01052714|141380305|SUPERIORITY|||||||0.652|||||||Mixed Models Analysis|||||||0.652
70940054|NCT01052714|141380306|SUPERIORITY|||||||0.663|||||||Mixed Models Analysis|||||||0.663
70940055|NCT01052714|141380307|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|||||||0.9
70940056|NCT01052714|141380308|SUPERIORITY|||||||0.415|||||||Mixed Models Analysis|||||||0.415
70940057|NCT01052714|141380309|SUPERIORITY|||||||0.687|||||||Mixed Models Analysis|||||||0.687
70940058|NCT01052714|141380310|SUPERIORITY|||||||0.22|||||||Mixed Models Analysis|||||||0.22
70940059|NCT01052714|141380311|SUPERIORITY|||||||0.059|||||||Mixed Models Analysis|||||||0.059
70940060|NCT01052714|141380312|SUPERIORITY|||||||0.79|||||||Mixed Models Analysis|||||||0.79
70940061|NCT01052714|141380313|SUPERIORITY|||||||0.146|||||||Mixed Models Analysis|||||||0.146
71072185|NCT03617861|141653150|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Abdominal Pain: Healthy Controls Secretin vs Healthy Controls Placebo||||0.25
71072186|NCT03617861|141653150|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Abdominal Pain: Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.57
71072187|NCT03617861|141653150|SUPERIORITY|||||||0.2375|||||||ANCOVA|||Abdominal Pain: Healthy Controls vs Functional Dyspepsia||||0.2375
71072188|NCT01668966|141653195|SUPERIORITY_OR_OTHER|||||||0.101|||||||Paired t-test|||Statistical analysis at Week 12||||0.101
71072189|NCT01668966|141653195|SUPERIORITY_OR_OTHER|||||||0.139|||||||Paired t-test|||Statistical analysis at Week 24||||0.139
71072190|NCT01668966|141653195|SUPERIORITY_OR_OTHER|||||||0.116|||||||Paired t-test|||Statistical analysis at Week 36||||0.116
71072191|NCT01668966|141653195|SUPERIORITY_OR_OTHER|||||||0.167|||||||Paired t-test|||Statistical analysis at Week 48||||0.167
71072192|NCT01668966|141653195|SUPERIORITY_OR_OTHER|||||||0.21|||||||Paired t-test|||Statistical analysis at Week 56||||0.210
71072193|NCT01668966|141653195|SUPERIORITY_OR_OTHER|||||||0.343|||||||Paired t-test|||Statistical analysis at Week 68||||0.343
71072194|NCT01668966|141653195|SUPERIORITY_OR_OTHER|||||||0.533|||||||Paired t-test|||Statistical analysis at Week 80||||0.533
71072195|NCT01668966|141653195|SUPERIORITY_OR_OTHER|||||||0.593|||||||Paired t-test|||Statistical analysis at Week 92||||0.593
71072196|NCT01668966|141653195|SUPERIORITY_OR_OTHER|||||||0.044|||||||Paired t-test|||Statistical analysis at Week 104||||0.044
70853156|NCT00955201|141194702|SUPERIORITY|||||||0.29|||||||ANOVA|||Comparison across groups at 24-wks.||||0.29
70853157|NCT00955201|141194703|SUPERIORITY|||||||0.97||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time||||0.97
70853158|NCT00955201|141194703|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
70853159|NCT00955201|141194703|SUPERIORITY|||||||0.09||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.09
70853160|NCT00955201|141194703|SUPERIORITY|||||||0.05||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.05
70940062|NCT01052714|141380314|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
70853161|NCT00955201|141194703|SUPERIORITY|||||||0.11|||||||ANOVA|||Comparison across groups at baseline.||||0.11
70853162|NCT00955201|141194703|SUPERIORITY|||||||0.41|||||||ANOVA|||Comparison across groups at 12-wks.||||0.41
70853163|NCT00955201|141194703|SUPERIORITY|||||||0.03|||||||ANOVA|||Comparison across groups at 24-wks.||||0.03
70853164|NCT00955201|141194704|SUPERIORITY|||||||0.95||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.95
70940063|NCT01052714|141380315|SUPERIORITY|||||||0.763|||||||Mixed Models Analysis|||||||0.763
70853165|NCT00955201|141194704|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
70853166|NCT00955201|141194704|SUPERIORITY|||||||0.87||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.87
70940064|NCT02168153|141380316|SUPERIORITY||Mean Difference (Final Values)|-3.49||||0.76|TWO_SIDED|95.0|-25.75|18.77|||ANCOVA|adjusted for age||Between group differences||18.77|-25.75|0.76
70940065|NCT02168153|141380317|SUPERIORITY||Mean Difference (Final Values)|0.97||||0.92|TWO_SIDED|95.0|-18.04|19.98|||ANCOVA|adjusted for age||Between group differences||19.98|-18.04|0.92
70940066|NCT02168153|141380318|SUPERIORITY||Mean Difference (Final Values)|3.49||||0.7|TWO_SIDED|95.0|-14.4|21.39|||ANCOVA|adjusted for age||Between group differences||21.39|-14.4|0.70
70940067|NCT02168153|141380319|SUPERIORITY||Mean Difference (Final Values)|0.988||||0.15|TWO_SIDED|95.0|-0.373|2.349|||ANCOVA|adjusted for age||Between group differences||2.349|-0.373|0.15
70853167|NCT00955201|141194704|SUPERIORITY|||||||0.48||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.48
70853168|NCT00955201|141194704|SUPERIORITY|||||||0.58|||||||ANOVA|||Comparison across groups at baseline.||||0.58
70853169|NCT00955201|141194704|SUPERIORITY|||||||0.5|||||||ANOVA|||Comparison across groups at 12-wks.||||0.50
70853170|NCT00955201|141194704|SUPERIORITY|||||||0.33|||||||ANOVA|||Comparison across groups at 24-wks.||||0.33
70853171|NCT00955201|141194705|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.98
70853172|NCT00955201|141194705|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
70853173|NCT00955201|141194705|SUPERIORITY|||||||0.88||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.88
70853174|NCT00955201|141194705|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.93
70853175|NCT00955201|141194705|SUPERIORITY|||||||0.38|||||||ANOVA|||Comparison across groups at baseline.||||0.38
70853176|NCT00955201|141194705|SUPERIORITY|||||||0.55|||||||ANOVA|||Comparison across groups at 12-wks.||||0.55
70853177|NCT00955201|141194705|SUPERIORITY|||||||0.37|||||||ANOVA|||Comparison across groups at 24-wks||||0.37
70853178|NCT00955201|141194706|SUPERIORITY|||||||1||||||Dunn's multiple comparisons test:|Kruskal-Wallis|||Evaluate within group across time||||1.00
70853179|NCT00955201|141194706|SUPERIORITY|||||||1||||||Dunn's multiple comparisons test:|Kruskal-Wallis|||Evaluate within group across time||||1.00
70853180|NCT00955201|141194706|SUPERIORITY|||||||1||||||Dunn's multiple comparisons test:|Kruskal-Wallis|||Evaluate within group across time||||1.00
70853181|NCT00955201|141194706|SUPERIORITY|||||||1||||||Dunn's multiple comparisons test:|Kruskal-Wallis|||Evaluate within group across time.||||1.00
70853182|NCT00955201|141194706|SUPERIORITY|||||||0.81|||||||Kruskal-Wallis|||Comparison across groups at baseline||||0.81
70940068|NCT02168153|141380320|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.32|TWO_SIDED|95.0|-1.24|0.41|||ANCOVA|adjusted for age||Between group differences||0.41|-1.24|0.32
71072197|NCT01668966|141653195|SUPERIORITY_OR_OTHER|||||||0.243|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.243
71072198|NCT01668966|141653195|SUPERIORITY_OR_OTHER|||||||0.009|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.009
71072199|NCT01668966|141653196|SUPERIORITY_OR_OTHER|||||||0.1853|||||||Paired t-test|||Statistical analysis at Week 12||||0.1853
71072200|NCT01668966|141653196|SUPERIORITY_OR_OTHER|||||||0.2992|||||||Paired t-test|||Statistical analysis at Week 24||||0.2992
71072201|NCT01668966|141653196|SUPERIORITY_OR_OTHER|||||||0.2249|||||||Paired t-test|||Statistical analysis at Week 36||||0.2249
71072202|NCT01668966|141653196|SUPERIORITY_OR_OTHER|||||||0.3102|||||||Paired t-test|||Statistical analysis at Week 48||||0.3102
71072203|NCT01668966|141653196|SUPERIORITY_OR_OTHER|||||||0.2164|||||||Paired t-test|||Statistical analysis at Week 56||||0.2164
71072204|NCT01668966|141653196|SUPERIORITY_OR_OTHER|||||||0.8822|||||||Paired t-test|||Statistical analysis at Week 68||||0.8822
71072205|NCT01668966|141653196|SUPERIORITY_OR_OTHER|||||||0.7649|||||||Paired t-test|||Statistical analysis at Week 80||||0.7649
71072206|NCT01668966|141653196|SUPERIORITY_OR_OTHER|||||||0.605|||||||Paired t-test|||Statistical analysis at Week 92||||0.6050
71072207|NCT01668966|141653196|SUPERIORITY_OR_OTHER|||||||0.4478|||||||Paired t-test|||Statistical analysis at Week 104||||0.4478
71072208|NCT01668966|141653196|SUPERIORITY_OR_OTHER|||||||0.4821|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.4821
71072209|NCT01668966|141653196|SUPERIORITY_OR_OTHER|||||||0.0522|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.0522
71072210|NCT01668966|141653197|SUPERIORITY_OR_OTHER|||||||0.0624|||||||Paired t-test|||Statistical analysis at Week 12||||0.0624
71072211|NCT01668966|141653197|SUPERIORITY_OR_OTHER|||||||0.0616|||||||Paired t-test|||Statistical analysis at Week 24||||0.0616
71072212|NCT01668966|141653197|SUPERIORITY_OR_OTHER|||||||0.248|||||||Paired t-test|||Statistical analysis at Week 36||||0.2480
71072213|NCT01668966|141653197|SUPERIORITY_OR_OTHER|||||||0.5393|||||||Paired t-test|||Statistical analysis at Week 48||||0.5393
70853183|NCT00955201|141194706|SUPERIORITY|||||||0.6|||||||Kruskal-Wallis|||Comparison across groups at 12-wks||||0.60
70853184|NCT00955201|141194706|SUPERIORITY|||||||0.99|||||||Kruskal-Wallis|||Comparison across groups at 24-wks||||0.99
70853185|NCT00955201|141194707|SUPERIORITY|||||||0.59|||||||ANOVA|||Comparison across groups at baseline.||||0.59
70853186|NCT00955201|141194708|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.98
70853187|NCT00955201|141194708|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
70853188|NCT00955201|141194708|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
70853189|NCT00955201|141194708|SUPERIORITY|||||||0.72||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.72
70853190|NCT00955201|141194708|SUPERIORITY|||||||0.62|||||||ANOVA|||Comparison across groups at baseline.||||0.62
70853191|NCT00955201|141194708|SUPERIORITY|||||||0.33|||||||ANOVA|||Comparison across groups at 12 wks.||||0.33
70853192|NCT00955201|141194708|SUPERIORITY|||||||0.38|||||||ANOVA|||Comparison across groups at 24 wks.||||0.38
70853193|NCT00955201|141194709|SUPERIORITY|||||||0.88||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.88
70853194|NCT00955201|141194709|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
70853195|NCT00955201|141194709|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
70853196|NCT00955201|141194709|SUPERIORITY|||||||0.76||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.76
70853197|NCT00955201|141194709|SUPERIORITY|||||||0.82|||||||ANOVA|||Comparison across groups at baseline.||||0.82
70853198|NCT00955201|141194709|SUPERIORITY|||||||0.53|||||||ANOVA|||Comparison across groups at 12 wks.||||0.53
70853199|NCT00955201|141194709|SUPERIORITY|||||||0.68|||||||ANOVA|||Comparison across groups at 24 wks.||||0.68
70853200|NCT00955201|141194710|SUPERIORITY|||||||0.7|||||||ANOVA|||Comparison across groups at baseline.||||0.70
70853201|NCT00955201|141194712|SUPERIORITY|||||||0.59|||||||ANOVA|||Comparison across groups at baseline.||||0.59
70853202|NCT00955201|141194713|SUPERIORITY|||||||0.45|||||||ANOVA|||Comparison across groups at baseline.||||0.45
70853203|NCT00955201|141194714|SUPERIORITY|||||||0.04|||||||ANOVA|||Comparison across groups at baseline.||||0.04
70853204|NCT00955201|141194715|SUPERIORITY|||||||0.77|||||||ANOVA|||Comparison across groups at baseline.||||0.77
70853205|NCT00955201|141194716|SUPERIORITY|||||||0.12|||||||ANOVA|||Comparison across groups at baseline.||||0.12
70853206|NCT00955201|141194717|SUPERIORITY|||||||0.42|||||||ANOVA|||Comparison across groups at baseline.||||0.42
70853207|NCT00955201|141194718|SUPERIORITY|||||||0.79|||||||ANOVA|||Comparison across groups at baseline.||||0.79
70853208|NCT03032380|141194719|NON_INFERIORITY|The study hypothesis was that the all-cause mortality rate at Day 14 in participants who received cefiderocol would be non-inferior to that in participants who received high-dose meropenem. The margin of non-inferiority was 12.5%. Non-inferiority was concluded if the upper bound of the 2-sided 95% confidence interval for the difference in mortality at Day 14 between the 2 treatment groups (cefiderocol - meropenem) was smaller than 12.5%.|Treatment Difference|0.8||||0.002|TWO_SIDED|95.0|-6.6|8.2|||Cochran-Mantel-Haenszel||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the ACM rate at Day 14 based on Cochran-Mantel Haenszel weights using APACHE II score (≤ 15 and ≥ 16) as the stratification factor.|||8.2|-6.6|0.0020
70853209|NCT03032380|141194720|SUPERIORITY||Treatment Difference|-1.4|||||TWO_SIDED|95.0|-13.5|10.7|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the eradication rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||10.7|-13.5|
70853210|NCT03032380|141194721|SUPERIORITY||Treatment Difference|-2.0|||||TWO_SIDED|95.0|-12.5|8.5|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||8.5|-12.5|
70853211|NCT03032380|141194722|OTHER||Treatment Difference|-0.3|||||TWO_SIDED|95.0|-8.8|8.2|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||8.2|-8.8|
70853212|NCT03032380|141194723|OTHER||Treatment Difference|-3.8|||||TWO_SIDED|95.0|-12.8|5.1|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||5.1|-12.8|
70853213|NCT03032380|141194724|OTHER||Treatment Difference|-0.1|||||TWO_SIDED|95.0|-10.9|10.8|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||10.8|-10.9|
70853214|NCT03032380|141194725|OTHER||Treatment Difference|-12.4|||||TWO_SIDED|95.0|-24.4|-0.5|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||-0.5|-24.4|
70853215|NCT03032380|141194726|OTHER||Treatment Difference|-3.8|||||TWO_SIDED|95.0|-15.5|7.9|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||7.9|-15.5|
71072214|NCT01668966|141653197|SUPERIORITY_OR_OTHER|||||||0.1401|||||||Paired t-test|||Statistical analysis at Week 56||||0.1401
71072215|NCT01668966|141653197|SUPERIORITY_OR_OTHER|||||||0.0679|||||||Paired t-test|||Statistical analysis at Week 68||||0.0679
71072216|NCT01668966|141653197|SUPERIORITY_OR_OTHER|||||||0.6017|||||||Paired t-test|||Statistical analysis at Week 80||||0.6017
71072217|NCT01668966|141653197|SUPERIORITY_OR_OTHER|||||||0.4772|||||||Paired t-test|||Statistical analysis at Week 92||||0.4772
71072218|NCT01668966|141653197|SUPERIORITY_OR_OTHER|||||||0.4877|||||||Paired t-test|||Statistical analysis at Week 104||||0.4877
70853216|NCT03032380|141194727|OTHER||Treatment Difference|3.9|||||TWO_SIDED|95.0|-7.9|15.8|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||15.8|-7.9|
70853217|NCT03032380|141194728|OTHER||Treatment Difference|0.5|||||TWO_SIDED|95.0|-8.7|9.8|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the ACM rate at Day 28 based on Cochran-Mantel Haenszel weights using APACHE II score (≤ 15 and ≥ 16) as the stratification factor.|||9.8|-8.7|
70853218|NCT03032380|141194729|OTHER||Treatment Difference|3.6|||||TWO_SIDED|95.0|-6.3|13.4|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the ACM rate at EOS based on Cochran-Mantel Haenszel weights using APACHE II score (≤ 15 and ≥ 16) as the stratification factor.|||13.4|-6.3|
71072219|NCT01668966|141653197|SUPERIORITY_OR_OTHER|||||||0.0624|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.0624
71072220|NCT01668966|141653197|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||<0.0001
71072221|NCT01668966|141653198|SUPERIORITY_OR_OTHER|||||||0.2388|||||||Paired t-test|||Statistical analysis at Week 12||||0.2388
71114634|NCT01942668|141737378|SUPERIORITY||Mean Difference (Final Values)|-12.05|STANDARD_ERROR_OF_MEAN|3.27|<|0.001|TWO_SIDED|95.0|-18.47|-5.64||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.64|-18.47|<0.001
70853219|NCT03032380|141194730|SUPERIORITY|||||||0.9382|||||||t-test, 2 sided|||Comparison of Hospitalization time at test of cure||||0.9382
70853220|NCT03032380|141194730|SUPERIORITY|||||||0.6552|||||||t-test, 2 sided|||Comparison of hospitalization time at follow-up||||0.6552
70853221|NCT04093024|141194769|OTHER||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.4||0.9858|TWO_SIDED|95.0|-0.8|0.8|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|No formal hypotheses were tested||0.8|-0.8|0.9858
70853222|NCT04093024|141194770|OTHER||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.8||0.9769|TWO_SIDED|95.0|-1.7|1.6|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|No formal hypotheses were tested||1.6|-1.7|0.9769
70853223|NCT04093024|141194772|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.4||0.4442|TWO_SIDED|95.0|-1.8|4.0|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||4.0|-1.8|0.4442
70853224|NCT04093024|141194775|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.8||0.882|TWO_SIDED|95.0|-1.5|1.8|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||1.8|-1.5|0.8820
70853225|NCT04093024|141194776|OTHER||Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|1.6||0.9652|TWO_SIDED|95.0|-3.2|3.3|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|No formal hypotheses were tested||3.3|-3.2|0.9652
70853226|NCT04093024|141194777|OTHER||Adjusted mean difference|-2.6|STANDARD_ERROR_OF_MEAN|3.1||0.4084|TWO_SIDED|95.0|-9.3|4.0|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|No formal hypotheses were tested||4.0|-9.3|0.4084
70853227|NCT04093024|141194778|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.8||0.9928|TWO_SIDED|95.0|-1.6|1.6|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||1.6|-1.6|0.9928
70853228|NCT04093024|141194779|OTHER||Adjusted mean difference|0.7|STANDARD_ERROR_OF_MEAN|1.4||0.6366|TWO_SIDED|95.0|-2.3|3.6|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|No formal hypotheses were tested||3.6|-2.3|0.6366
70853229|NCT04093024|141194780|OTHER||Adjusted mean difference|0.4|STANDARD_ERROR_OF_MEAN|2.3||0.8823|TWO_SIDED|95.0|-5.2|5.9|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|No formal hypotheses were tested||5.9|-5.2|0.8823
71072222|NCT01668966|141653198|SUPERIORITY_OR_OTHER|||||||0.1084|||||||Paired t-test|||Statistical analysis at Week 24||||0.1084
71072223|NCT01668966|141653198|SUPERIORITY_OR_OTHER|||||||0.0321|||||||Paired t-test|||Statistical analysis at Week 36||||0.0321
71114635|NCT01942668|141737379|SUPERIORITY||Mean Difference (Final Values)|-17.87|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-24.57|-11.05||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-11.05|-24.57|<0.001
71114636|NCT01942668|141737379|SUPERIORITY||Mean Difference (Final Values)|-11.35|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-18.0|-4.7||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.70|-18.00|<0.001
71072224|NCT01668966|141653198|SUPERIORITY_OR_OTHER|||||||0.0203|||||||Paired t-test|||Statistical analysis at Week 48||||0.0203
71072225|NCT01668966|141653198|SUPERIORITY_OR_OTHER|||||||0.0193|||||||Paired t-test|||Statistical analysis at Week 56||||0.0193
71072226|NCT01668966|141653198|SUPERIORITY_OR_OTHER|||||||0.6235|||||||Paired t-test|||Statistical analysis at Week 68||||0.6235
71072227|NCT01668966|141653198|SUPERIORITY_OR_OTHER|||||||0.2814|||||||Paired t-test|||Statistical analysis at Week 80||||0.2814
71072228|NCT01668966|141653198|SUPERIORITY_OR_OTHER|||||||0.3391|||||||Paired t-test|||Statistical analysis at Week 92||||0.3391
71072229|NCT01668966|141653198|SUPERIORITY_OR_OTHER|||||||0.1605|||||||Paired t-test|||Statistical analysis at Week 104||||0.1605
71072230|NCT01668966|141653198|SUPERIORITY_OR_OTHER|||||||0.4312|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.4312
71072231|NCT01668966|141653201|SUPERIORITY_OR_OTHER|||||||0.934|||||||Paired t-test|||Statistical analysis at Week 12||||0.934
71072232|NCT01668966|141653201|SUPERIORITY_OR_OTHER|||||||0.624|||||||Paired t-test|||Statistical analysis at Week 24||||0.624
71072233|NCT01668966|141653201|SUPERIORITY_OR_OTHER|||||||0.642|||||||Paired t-test|||Statistical analysis at Week 36||||0.642
71072234|NCT01668966|141653201|SUPERIORITY_OR_OTHER|||||||0.952|||||||Paired t-test|||Statistical analysis at Week 48||||0.952
71072235|NCT01668966|141653201|SUPERIORITY_OR_OTHER|||||||0.928|||||||Paired t-test|||Statistical analysis at Week 56||||0.928
71072236|NCT01668966|141653201|SUPERIORITY_OR_OTHER|||||||0.832|||||||Paired t-test|||Statistical analysis at Week 68||||0.832
70940069|NCT01184755|141380343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.561256|STANDARD_ERROR_OF_MEAN|0.216403||0.01|TWO_SIDED|95.0|-0.987999|-0.134513||This is an intention-to-treat analysis|Mixed effects regression analysis|||This is the change in Systolic BP at 8 weeks||-.134513|-.987999|.01
71072237|NCT01668966|141653201|SUPERIORITY_OR_OTHER|||||||0.315|||||||Paired t-test|||Statistical analysis at Week 80||||0.315
71072238|NCT01668966|141653201|SUPERIORITY_OR_OTHER|||||||0.485|||||||Paired t-test|||Statistical analysis at Week 92||||0.485
71072239|NCT01668966|141653201|SUPERIORITY_OR_OTHER|||||||0.246|||||||Paired t-test|||Statistical analysis at Week 104||||0.246
71072240|NCT01668966|141653201|SUPERIORITY_OR_OTHER|||||||0.375|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.375
71072241|NCT01668966|141653201|SUPERIORITY_OR_OTHER|||||||0.185|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.185
71072242|NCT01668966|141653202|SUPERIORITY_OR_OTHER|||||||0.445|||||||Paired t-test|||Statistical analysis at Week 12||||0.445
71072243|NCT01668966|141653202|SUPERIORITY_OR_OTHER|||||||0.414|||||||Paired t-test|||Statistical analysis at Week 24||||0.414
71072244|NCT01668966|141653202|SUPERIORITY_OR_OTHER|||||||0.401|||||||Paired t-test|||Statistical analysis at Week 36||||0.401
71072245|NCT01668966|141653202|SUPERIORITY_OR_OTHER|||||||0.92|||||||Paired t-test|||Statistical analysis at Week 48||||0.920
71072246|NCT01668966|141653202|SUPERIORITY_OR_OTHER|||||||0.834|||||||Paired t-test|||Statistical analysis at Week 56||||0.834
71072247|NCT01668966|141653202|SUPERIORITY_OR_OTHER|||||||0.539|||||||Paired t-test|||Statistical analysis at Week 68||||0.539
71072248|NCT01668966|141653202|SUPERIORITY_OR_OTHER|||||||0.246|||||||Paired t-test|||Statistical analysis at Week 80||||0.246
71072249|NCT01668966|141653202|SUPERIORITY_OR_OTHER|||||||0.602|||||||Paired t-test|||Statistical analysis at Week 92||||0.602
71072250|NCT01668966|141653202|SUPERIORITY_OR_OTHER|||||||0.218|||||||Paired t-test|||Statistical analysis at Week 104||||0.218
71072251|NCT01668966|141653202|SUPERIORITY_OR_OTHER|||||||0.208|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.208
71072252|NCT01668966|141653202|SUPERIORITY_OR_OTHER|||||||0.101|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.101
71072253|NCT01668966|141653203|SUPERIORITY_OR_OTHER|||||||0.565|||||||Paired t-test|||Statistical analysis at Week 12||||0.565
71072254|NCT01668966|141653203|SUPERIORITY_OR_OTHER|||||||0.637|||||||Paired t-test|||Statistical analysis at Week 24||||0.637
71072255|NCT01668966|141653203|SUPERIORITY_OR_OTHER|||||||0.594|||||||Paired t-test|||Statistical analysis at Week 36||||0.594
71072256|NCT01668966|141653203|SUPERIORITY_OR_OTHER|||||||0.788|||||||Paired t-test|||Statistical analysis at Week 48||||0.788
71072257|NCT01668966|141653203|SUPERIORITY_OR_OTHER|||||||0.329|||||||Paired t-test|||Statistical analysis at Week 56||||0.329
71072258|NCT01668966|141653203|SUPERIORITY_OR_OTHER|||||||0.716|||||||Paired t-test|||Statistical analysis at Week 68||||0.716
71072259|NCT01668966|141653203|SUPERIORITY_OR_OTHER|||||||0.119|||||||Paired t-test|||Statistical analysis at Week 80||||0.119
71072260|NCT01668966|141653203|SUPERIORITY_OR_OTHER|||||||0.201|||||||Paired t-test|||Statistical analysis at Week 92||||0.201
71072261|NCT01668966|141653203|SUPERIORITY_OR_OTHER|||||||0.087|||||||Paired t-test|||Statistical analysis at Week 104||||0.087
71072262|NCT01668966|141653203|SUPERIORITY_OR_OTHER|||||||0.116|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.116
71072263|NCT01668966|141653203|SUPERIORITY_OR_OTHER|||||||0.07|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.070
71072264|NCT01668966|141653204|SUPERIORITY_OR_OTHER|||||||0.3299|||||||Paired t-test|||Statistical analysis at Week 12||||0.3299
71072265|NCT01668966|141653204|SUPERIORITY_OR_OTHER|||||||0.9247|||||||Paired t-test|||Statistical analysis at Week 24||||0.9247
71072266|NCT01668966|141653204|SUPERIORITY_OR_OTHER|||||||0.9602|||||||Paired t-test|||Statistical analysis at Week 36||||0.9602
71072267|NCT01668966|141653204|SUPERIORITY_OR_OTHER|||||||0.2773|||||||Paired t-test|||Statistical analysis at Week 48||||0.2773
71072268|NCT01668966|141653204|SUPERIORITY_OR_OTHER|||||||0.5031|||||||Paired t-test|||Statistical analysis at Week 56||||0.5031
71072269|NCT01668966|141653204|SUPERIORITY_OR_OTHER|||||||0.8109|||||||Paired t-test|||Statistical analysis at Week 68||||0.8109
71072270|NCT01668966|141653204|SUPERIORITY_OR_OTHER|||||||0.254|||||||Paired t-test|||Statistical analysis at Week 80||||0.2540
71072271|NCT01668966|141653204|SUPERIORITY_OR_OTHER|||||||0.3794|||||||Paired t-test|||Statistical analysis at Week 92||||0.3794
71072272|NCT01668966|141653204|SUPERIORITY_OR_OTHER|||||||0.8687|||||||Paired t-test|||Statistical analysis at Week 104||||0.8687
71072273|NCT01668966|141653204|SUPERIORITY_OR_OTHER|||||||0.4685|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.4685
71072274|NCT01668966|141653204|SUPERIORITY_OR_OTHER|||||||0.0511|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.0511
71072275|NCT01643798|141653236|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71072276|NCT01643798|141653236|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||||||0.04
71072277|NCT01643798|141653237|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||ANOVA|||||||.0003
71072278|NCT01643798|141653237|SUPERIORITY_OR_OTHER|||||||0.794||95.0|||||ANOVA|||||||0.794
71078660|NCT06010732|141665267|SUPERIORITY||Ratio of Means|0.97||||0.092|TWO_SIDED|95.0|0.93|1.01||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Positive Control/Placebo|analyzed as log(%CAR+100)||1.01|0.93|0.092
71114637|NCT01942668|141737379|SUPERIORITY||Mean Difference (Final Values)|-7.82|STANDARD_ERROR_OF_MEAN|3.4||0.022|TWO_SIDED|95.0|-14.5|-1.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-1.14|-14.50|0.022
71114638|NCT01942668|141737379|SUPERIORITY||Mean Difference (Final Values)|-12.51|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|-19.11|-5.91||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.91|-19.11|<0.001
71114639|NCT01942668|141737380|SUPERIORITY||Mean Difference (Final Values)|-17.75|STANDARD_ERROR_OF_MEAN|3.41|<|0.001|TWO_SIDED|95.0|-24.45|-11.06||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-11.06|-24.45|<0.001
70853230|NCT04093024|141194781|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|1.2052|STANDARD_ERROR_OF_MEAN|2.2491||0.5962|TWO_SIDED|95.0|-3.3966|5.807|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||5.8070|-3.3966|0.5962
70940070|NCT01184755|141380343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.391195|STANDARD_ERROR_OF_MEAN|0.140034||0.006|TWO_SIDED|95.0|-0.667312|-0.115079|||mixed effects regression analysis|||This is the analysis of change in diastolic BP from Ambulatory BP monitoring.||-.115079|-.667312|.006
71078661|NCT06010732|141665268|SUPERIORITY||Ratio of Means|1.01||||0.905|TWO_SIDED|95.0|0.9|1.13||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Positive Control|analyzed as log(∆Z)||1.13|0.90|0.905
71078662|NCT06010732|141665268|SUPERIORITY||Ratio of Means|0.71|||<|0.001|TWO_SIDED|95.0|0.63|0.8||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Placebo|analyzed as log(∆Z)||0.80|0.63|<0.001
71114640|NCT01942668|141737380|SUPERIORITY||Mean Difference (Final Values)|-13.29|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|-19.88|-6.7||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.70|-19.88|<0.001
71114641|NCT01942668|141737380|SUPERIORITY||Mean Difference (Final Values)|-10.22|STANDARD_ERROR_OF_MEAN|3.37||0.003|TWO_SIDED|95.0|-16.83|-3.6||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-3.60|-16.83|0.003
71114642|NCT01942668|141737380|SUPERIORITY||Mean Difference (Final Values)|-13.61|STANDARD_ERROR_OF_MEAN|3.33|<|0.001|TWO_SIDED|95.0|-20.15|-7.07||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-7.07|-20.15|<0.001
71114643|NCT01942668|141737381|SUPERIORITY||Mean Difference (Final Values)|-16.63|STANDARD_ERROR_OF_MEAN|3.42|<|0.001|TWO_SIDED|95.0|-23.35|-9.91||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-9.91|-23.35|<0.001
71078663|NCT06010732|141665268|SUPERIORITY||Ratio of Means|0.7|||<|0.001|TWO_SIDED|95.0|0.63|0.79||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Positive Control/Placebo|analyzed as log(∆Z)||0.79|0.63|<0.001
71078664|NCT06010732|141665269|SUPERIORITY||Ratio of Means|0.98||||0.721|TWO_SIDED|95.0|0.88|1.09||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Positive Control|analyzed as log(lesion depth)||1.09|0.88|0.721
71078665|NCT06010732|141665269|SUPERIORITY||Ratio of Means|0.75|||<|0.001|TWO_SIDED|95.0|0.68|0.84||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Placebo|analyzed as log(lesion depth)||0.84|0.68|<0.001
71114644|NCT01942668|141737381|SUPERIORITY||Mean Difference (Final Values)|-12.97|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-19.58|-6.36||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.36|-19.58|<0.001
70940071|NCT00318591|141380344|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The additional explanatory variables were removed using backwards-elimination removing the least significant additional variable for each iteration, until the effect of all included additional variables was significant on α=0.05 significant level. The null-hypothesis of no catheter difference was to be rejected on α=0.05 significant level.|Hazard Ratio (HR)|1.502||||0.0383|TWO_SIDED|95.0|1.022|2.207||p-value is adjusted for the following explanatory variables: catheterization frequency, technique (clean/sterile), procedure (participant/nurse), setting (hospital/community) and demographic measures.|Kaplan-Meier|||The analysis was done by comparing Kaplan-Meier estimates of the survival function of the two groups. The analysis was refined by a Cox proportional hazards regression model for survival data.||2.207|1.022|0.0383
70940072|NCT00318591|141380346|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA analysis. Limit of significant difference \<0.05||||||0.767||95.0||||baseline characteristics were used as covariates, catheterization procedure (participant or caregiver) as well as technique (sterile or clean). Backward elimination was used.|ANOVA|||||||0.7670
70940073|NCT00318591|141380347|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA. Level of significant difference \<0.05||||||0.0074||95.0||||baseline characteristics were used as covariates, catheterization procedure (participant or caregiver) as well as technique (sterile or clean). Backward elimination was used.|ANOVA|||||||0.0074
70940074|NCT01612221|141380353|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||.65
70940075|NCT01612221|141380354|SUPERIORITY|||||||0.76|||||||ANCOVA|||GCLM Biomarker analysis.||||0.76
70940076|NCT01612221|141380354|SUPERIORITY|||||||0.63|||||||ANCOVA|||SLC1A4 Biomarker analysis.||||0.63
70940077|NCT01612221|141380354|SUPERIORITY|||||||0.27|||||||ANCOVA|||SLC7A11 Biomarker analysis.||||0.27
70940078|NCT00644332|141380359|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7|STANDARD_ERROR_OF_MEAN|0.5||||||||||||Mean change in angina frequency from Baseline to Week 4||||
71072279|NCT00614120|141653289|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is concluded if the two-sided upper limit of the 95% confidence interval for treatment difference in mean change in HbA1c between lira 1.8mg + met and glim + met is below 0.4%.|Estimated treatment difference, LS Mean|-0.06|||<|0.0001||95.0|-0.23|0.11||Non-inferiority; \<.0001. In order to protect the overall Type I error rate when testing for non-inferiority of the three doses of lira + met to glim + met, the comparisons will be invoked sequentially for descending doses of liraglutide.|ANCOVA|ANCOVA model with treatment, country and previous treatment as fixed effects and baseline value as a covariate.|The p-values correspond to one-sided hypotheses of either superiority or non-inferiority. Statistical significance on a 2.5% level.|"Based on standard normal theory, the sample size needed in order to be able to show that lira + met is non-inferior to glim + met when using a 1:1 randomisation and a non-inferiority criteria of 0.4% with a power of at least 85%, is tabulated below using different SD of HbA1c.~Assuming a drop out rate of 25%, the total number of subjects to be randomised is 896 (224 for each dose of the liraglutide + metformin group and 224 subjects in metformin+glimepiride treatment group) with a SD of 1.2%."||0.11|-0.23|<0.0001
71078666|NCT06010732|141665269|SUPERIORITY||Ratio of Means|0.77|||<|0.001|TWO_SIDED|95.0|0.69|0.86||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Positive Control/Placebo|analyzed as log(lesion depth)||0.86|0.69|<0.001
70853231|NCT04093024|141194782|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|1.7733|STANDARD_ERROR_OF_MEAN|3.1424||0.5776|TWO_SIDED|95.0|-4.7015|8.2481|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||8.2481|-4.7015|0.5776
70940079|NCT00644332|141380360|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2|STANDARD_ERROR_OF_MEAN|0.5||||||||||||Mean change in NTG use from Baseline to Week 4||||
70940080|NCT00644332|141380361|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9|STANDARD_ERROR_OF_MEAN|0.8||||||||||||||||
70940081|NCT00627523|141380371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|0.82|1.59||ANCOVA model, fitting treatment as a factor, and the baseline parameter value as covariate was used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference in the mean change from Baseline after 24 months in height SDS between the Genotropin® and the untreated control groups. The alternative hypothesis was that there was a difference between the treatment groups.||1.59|0.82|<0.001
70940082|NCT00627523|141380372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|0.81||0.348|TWO_SIDED|95.0|-0.87|2.42||ANCOVA model, fitting treatment as a factor, and the baseline parameter value as covariate was used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference between the Genotropin® and the untreated control group in terms of the relevant secondary endpoints. The alternative hypothesis was that a difference existed.||2.42|-0.87|0.348
70940083|NCT00627523|141380373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|0.55|1.23||ANCOVA model, fitting treatment as a factor, and the baseline parameter value as covariate was used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference between the Genotropin® and the untreated control group in terms of the relevant secondary endpoints. The alternative hypothesis was that a difference existed.||1.23|0.55|<0.001
70940084|NCT00627523|141380374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.24|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|1.63|4.85||ANCOVA model, fitting treatment as a factor, and the baseline parameter value as covariate was used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference between the Genotropin® and the untreated control group in terms of the relevant secondary endpoints. The alternative hypothesis was that a difference existed.||4.85|1.63|<0.001
70941972|NCT04380688|141384256|OTHER|No formal hypothesis testing for this endpoint.|Hazard Ratio (HR)|0.553|||||TWO_SIDED|90.0|0.145|1.952||P-value not generated.|Regression, Cox|Adjusting for age (\<65 vs \>=65 years) and comorbidities (present vs absent). Ties handled by Efron approach. HR CI using profile likelihood approach.||||1.952|0.145|
70853232|NCT04093024|141194783|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|-0.134|STANDARD_ERROR_OF_MEAN|4.316||0.9755|TWO_SIDED|95.0|-8.975|8.707|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||8.707|-8.975|0.9755
70940085|NCT00627523|141380375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.43|STANDARD_ERROR_OF_MEAN|7.19||0.738|TWO_SIDED|95.0|-12.27|17.12||ANCOVA model, fitting treatment as a factor, and the baseline parameter value, age, and gender as covariates were used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference between the Genotropin® and the untreated control group in terms of the relevant secondary endpoints. The alternative hypothesis was that a difference existed.||17.12|-12.27|0.738
71072280|NCT00614120|141653289|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is concluded if the two-sided upper limit of the 95% confidence interval for treatment difference in mean change in HbA1c between lira 1.2mg + met and glim + met is below 0.4%.|Estimated treatment difference, LS Mean|0.03|||<|0.0001||95.0|-0.14|0.2||In order to protect the overall Type I error rate when testing for non-inferiority of the three doses of lira + met to glim + met, the comparisons will be invoked sequentially for descending doses of liraglutide.|ANCOVA|ANCOVA model with treatment, country and previous treatment as fixed effects and baseline value as a covariate.|The p-values correspond to one-sided hypotheses of either superiority or non-inferiority. Statistical significance on a 2.5% level.|"Based on standard normal theory, the sample size needed in order to be able to show that lira + met is non-inferior to glim + met when using a 1:1 randomisation and a non-inferiority criteria of 0.4% with a power of at least 85%, is tabulated below using different SD of HbA1c.~Assuming a drop out rate of 25%, the total number of subjects to be randomised is 896 (224 for each dose of the liraglutide + metformin group and 224 subjects in metformin+glimepiride treatment group) with a SD of 1.2%."||0.20|-0.14|<.0001
71072281|NCT00614120|141653289|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is concluded if the two-sided upper limit of the 95% confidence interval for treatment difference in mean change in HbA1c between lira 0.6mg + met and glim + met is below 0.4%.|Estimated treatment difference, LS Mean|0.25||||0.0421||95.0|0.08|0.42||In order to protect the overall Type I error rate when testing for non-inferiority of the three doses of lira + met to glim + met, the comparisons will be invoked sequentially for descending doses of liraglutide.|ANCOVA|ANCOVA model with treatment, country and previous treatment as fixed effects and baseline value as a covariate.|The p-values correspond to one-sided hypotheses of either superiority or non-inferiority.|"Based on standard normal theory, the sample size needed in order to be able to show that lira + met is non-inferior to glim + met when using a 1:1 randomisation and a non-inferiority criteria of 0.4% with a power of at least 85%, is tabulated below using different SD of HbA1c.~Assuming a drop out rate of 25%, the total number of subjects to be randomised is 896 (224 for each dose of the liraglutide + metformin group and 224 subjects in metformin+glimepiride treatment group) with a SD of 1.2%."||0.42|0.08|0.0421
71072282|NCT00819780|141653328|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.871||||0.3531|TWO_SIDED|95.0|0.651|1.166|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||1.166|0.651|0.3531
71072283|NCT00819780|141653329|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.723||||0.1386|TWO_SIDED|95.0|0.47|1.111|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||1.111|0.470|0.1386
71072284|NCT00819780|141653330|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.19||||0.5497|TWO_SIDED|95.0|0.72|1.95|||Stratified exact test|Stratified by prior adjuvant oxaliplatin therapy|The odds ratio is defined as the odds of having an objective response in the panitumumab plus mFOLFOX6 arm relative to the odds in the bevacizumab plus mFOLFOX6 arm.|||1.95|0.72|0.5497
71072285|NCT00819780|141653332|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.874||||0.3861|TWO_SIDED|95.0|0.645|1.185|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||1.185|0.645|0.3861
71072286|NCT00819780|141653335|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.651||||0.0286|TWO_SIDED|95.0|0.444|0.956|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||0.956|0.444|0.0286
71072287|NCT00819780|141653336|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.579||||0.0083|TWO_SIDED|95.0|0.386|0.869|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||0.869|0.386|0.0083
71072288|NCT00819780|141653337|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.606||||0.0934|TWO_SIDED|95.0|0.337|1.088|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant Oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||1.088|0.337|0.0934
71072289|NCT00819780|141653338|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.465||||0.0235|TWO_SIDED|95.0|0.239|0.902|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||0.902|0.239|0.0235
71072290|NCT00819780|141653339|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.08||||0.9426|TWO_SIDED|95.0|0.55|2.12|||Stratified exact test|Stratified by prior exposure to oxaliplatin|The odds ratio is defined as the odds of having an objective response in the panitumumab plus mFOLFOX6 arm relative to the odds in the bevacizumab plus mFOLFOX6 arm.|||2.12|0.55|0.9426
71072291|NCT00819780|141653340|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||1|TWO_SIDED|95.0|0.52|2.15|||Stratified exact test|Stratified by prior exposure to oxaliplatin|The odds ratio is defined as the odds of having an objective response in the panitumumab plus mFOLFOX6 arm relative to the odds in the bevacizumab plus mFOLFOX6 arm.|||2.15|0.52|1.0000
71072292|NCT02484651|141653348|SUPERIORITY|||||||0.651|||||||t-test, 2 sided|||Sample size calculation was performed with a power of 0.80 and an α of 0.05, considering the primary hypothesis of a reduction in the BIS variability (measured as the standard deviation). A 25% reduction on the BIS variability (standard deviation) was considered clinically relevant, and gave a minimum sample size of 26 per group.||||0.651
71072293|NCT02484651|141653349|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||This statistical analysis applies to the propofol effect-site concentration. Sample size calculation was performed with a power of 0.80 and an α of 0.05 also a reduction in the propofol drug consumption (measured as the average effect-site concentration) during maintenance of anesthesia. A reduction on propofol mean effect-site concentration of 20% was considered clinically relevant, giving a minimum of 34 patients per group||||<0.001
71072294|NCT02484651|141653349|SUPERIORITY|||||||0.245|||||||t-test, 2 sided|||"This statistical analysis applies to the remifentanil effect-site concentration.~Sample size calculation was performed with a power of 0.80 and an α of 0.05 also a reduction in the remifentanil drug consumption (measured as the average effect-site concentration) during maintenance of anesthesia. A reduction on on remifentanil average effect-site concentration of 20% was considered clinically relevant, giving a minimum of 24 patients per group"||||0.245
71072295|NCT02484651|141653350|SUPERIORITY|||||||0.419|||||||Fisher Exact|||The null hypothesis was that PQRS overall recovery at 15 minutes was independent from the study group.||||0.419
71072296|NCT02484651|141653350|SUPERIORITY|||||||0.107|||||||Fisher Exact|||The null hypothesis was that PQRS overall recovery at 40 minutes was independent from the study group.||||0.107
71072297|NCT02484651|141653351|SUPERIORITY|||||||0.669|||||||Chi-squared|||The null hypothesis was that PQRS satisfaction with anesthetic care was independent of the study group.||||0.669
71072298|NCT04972968|141653364|SUPERIORITY||Cox Proportional Hazard|0.49||||0.012|TWO_SIDED|95.0|0.273|0.878||P-value \<= 0.05|Log Rank|Stratified by baseline randomization stratification factors \[Glucocorticoid use at Baseline (\>= 10 mg/day; \< 10 mg/day prednisone equivalent)\].||||0.878|0.273|0.012
71072299|NCT04972968|141653364|SUPERIORITY||Cox Proportional Hazard|0.443||||0.004|TWO_SIDED|95.0|0.248|0.794||P-value \<= 0.01|Log Rank|Stratified by baseline randomization stratification factors \[Glucocorticoid use at Baseline (\>= 10 mg/day; \< 10 mg/day prednisone equivalent)\]||||0.794|0.248|0.004
71072300|NCT04972968|141653364|SUPERIORITY||Cox Proportional Hazard|0.198|||<|0.001|TWO_SIDED|95.0|0.094|0.419||P-value \<= 0.001|Log Rank|Stratified by baseline randomization stratification factors \[Glucocorticoid use at Baseline (\>= 10 mg/day; \< 10 mg/day prednisone equivalent)\]||||0.419|0.094|<0.001
71072301|NCT04972968|141653365|SUPERIORITY||Mean Difference (Net)|18.7||||0.107|TWO_SIDED|95.0|-4.0|41.4|||Cochran-Mantel-Haenszel||From Cochran-Mantel-Haenszel test adjusting for baseline randomization stratification factors \[Glucocorticoid (GC) use at baseline (≥ 10 mg/day; \< 10 mg/day prednisone equivalent); Length of prior GC treatment for PMR (≤ 1 year; \> 1 year)\].|||41.4|-4.0|0.107
70941973|NCT04380688|141384264|OTHER|No formal hypothesis testing for this endpoint.|Hazard Ratio (HR)|1.314|||||TWO_SIDED|90.0|0.794|2.183||P-value not generated.|Regression, Cox|Adjusting for age (\<65 vs \>=65 years) and comorbidities (present vs absent). Ties handled by Efron approach. HR CI using profile likelihood approach.||||2.183|0.794|
71072302|NCT04972968|141653365|SUPERIORITY||Mean Difference (Net)|18.9||||0.092|TWO_SIDED|95.0|-3.1|41.0||P-value ≤ 0.1|Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel test adjusting for baseline randomization stratification factors \[Glucocorticoid use at baseline (≥ 10 mg/day; \< 10 mg/day prednisone equivalent); Length of prior GC treatment for PMR (≤ 1 year; \> 1 year)\].|||41.0|-3.1|0.092
71072303|NCT04972968|141653365|SUPERIORITY||Mean Difference (Net)|41.9|||<|0.001|TWO_SIDED|95.0|21.4|62.3||P-value ≤ 0.001|Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel test adjusting for baseline randomization stratification factors \[Glucocorticoid use at baseline (≥ 10 mg/day; \< 10 mg/day prednisone equivalent); Length of prior GC treatment for PMR (≤ 1 year; \> 1 year)\].|||62.3|21.4|< 0.001
71072304|NCT04972968|141653366|SUPERIORITY||Mean Difference (Net)|-88.67||||0.144|TWO_SIDED|95.0|-208.04|30.71|||ANCOVA|P-value based on an Analysis of covariance (ANCOVA) model adjusting for baseline randomization stratification factors.|95% CI based on an Analysis of covariance (ANCOVA) model adjusting for baseline randomization stratification factors \[GC use at baseline (≥ 10 mg/day; \< 10 mg/day prednisone equivalent);|||30.71|-208.04|0.144
71072305|NCT04972968|141653366|SUPERIORITY||Mean Difference (Net)|-164.76||||0.007|TWO_SIDED|95.0|-283.62|-45.89||P-value ≤ 0.01|ANCOVA||P-value and 95% CI are based on an Analysis of covariance (ANCOVA) model adjusting for baseline randomization stratification factors \[Glucocorticoid use at baseline (≥ 10 mg/day; \< 10 mg/day prednisone\] equivalent);|||-45.89|-283.62|0.007
71072306|NCT04972968|141653366|SUPERIORITY||Mean Difference (Final Values)|-182.55||||0.003|TWO_SIDED|95.0|-300.52|-64.58||P-value ≤ 0.01|ANCOVA||P-value and 95% CI based on an Analysis of covariance (ANCOVA) model adjusting for baseline randomization stratification factors \[Glucocorticoid use at baseline (≥ 10 mg/day; \< 10 mg/day prednisone equivalent)|||-64.58|-300.52|0.003
71072307|NCT04972968|141653367|SUPERIORITY||Mean Difference (Net)|-1.58||||0.039|TWO_SIDED|95.0|-3.08|-0.08||P-value \<= 0.05|ANCOVA|P-value based on ANCOVA adjusting for baseline randomization stratification factors (GC use at baseline)||||-0.08|-3.08|0.039
71072308|NCT04972968|141653367|SUPERIORITY||Mean Difference (Final Values)|-2.66|||<|0.001|TWO_SIDED|95.0|-4.15|-1.16||P-value \<= 0.001|ANCOVA|P-value based on an ANCOVA model adjusting for baseline randomization stratification factors (GC use at baseline)|95% CI based on an ANCOVA model adjusting for baseline randomization stratification factors (GC use at baseline)|||-1.16|-4.15|<0.001
71072309|NCT04972968|141653367|SUPERIORITY||Mean Difference (Final Values)|-3.0|||<|0.001|TWO_SIDED|95.0|-4.49|-1.52||P-value \<= 0.001|ANCOVA|P-value based on an ANCOVA model adjusting for baseline randomization stratification factors (GC use at baseline)|95% CI based on an ANCOVA model adjusting for baseline randomization stratification factors (GC use at baseline)|||-1.52|-4.49|<0.001
70853233|NCT04093024|141194784|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|3.453|STANDARD_ERROR_OF_MEAN|5.225||0.514|TWO_SIDED|95.0|-7.25|14.157|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||14.157|-7.250|0.5140
71072310|NCT01565369|141653397|SUPERIORITY_OR_OTHER||Fleiss' kappa|0.8547|STANDARD_ERROR_OF_MEAN|0.0282|<|0.0001||95.0||||evaluated at the .05 significance level|Fleiss' kappa|||Fleiss' kappa||||<0.0001
71072311|NCT00606554|141653406|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.60
71072312|NCT00606554|141653410|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
71072313|NCT00606554|141653413|SUPERIORITY_OR_OTHER|||||||0.9|||||||Chi-squared|||||||0.90
71072314|NCT04545567|141653427|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
70940086|NCT00627523|141380376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.51|STANDARD_ERROR_OF_MEAN|4.27||0.301|TWO_SIDED|95.0|-13.27|4.26||ANCOVA model, fitting treatment as a factor, and the baseline parameter value, age, and gender as covariates were used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference between the Genotropin® and the untreated control group in terms of the relevant secondary endpoints. The alternative hypothesis was that a difference existed.||4.26|-13.27|0.301
70940087|NCT03602053|141380407|NON_INFERIORITY|If the lower limit of the 95% CI of the ratio of GMCs between the ROTAVAC 5D® and ROTAVAC® groups was larger than 1/2 (i.e. \> 0.5), ROTAVAC 5D® would be considered non-inferior to ROTAVAC®.|GMC ratio|1.294|||||TWO_SIDED|95.0|0.862|1.924|||t-test, 2 sided|||||1.924|0.862|
70940088|NCT00168805|141380451|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 9.2%. This results from the null-hypotheses of non-inferiority testing, where the absolute risk difference has to be below 9.2%. Non-inferiority can only be shown with CI.|Risk Difference (Percentage)|-1.3||||0.6648||95.0|-7.3|4.6||p-value is for superiority testing|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||4.6|-7.3|0.6648
70940089|NCT00168805|141380451|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 9.2%. This results from the null-hypotheses of non-inferiority testing, where the absolute risk difference has to be below 9.2%. Non-inferiority can only be shown with CI.|Risk Difference (Percentage)|2.8||||0.3553||95.0|-3.1|8.7||p-value is for superiority testing|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||8.7|-3.1|0.3553
70940090|NCT00168805|141380452|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-1.0||||0.376||95.0|-3.1|1.2|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||1.2|-3.1|0.3760
70940091|NCT00168805|141380452|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.3||||0.8151||95.0|-2.0|2.6|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||2.6|-2.0|0.8151
70940092|NCT00168805|141380453|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.8||||0.4715||95.0|-2.8|1.3|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||1.3|-2.8|0.4715
70940093|NCT00168805|141380453|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.1||||0.9325||95.0|-2.1|2.3|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||2.3|-2.1|0.9325
71072315|NCT04545567|141653428|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.26
71072316|NCT04545567|141653429|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
71072317|NCT04545567|141653430|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
71072318|NCT04545567|141653431|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
71072319|NCT04545567|141653432|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||||||0.21
70940094|NCT00168805|141380454|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-1.4||||0.6463||95.0|-7.3|4.5|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||4.5|-7.3|0.6463
70940095|NCT00168805|141380454|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|2.7||||0.374||95.0|-3.2|8.6|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||8.6|-3.2|0.3740
71072320|NCT04545567|141653433|SUPERIORITY||Mean Difference (Final Values)|0.73||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
71072321|NCT04545567|141653434|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70940096|NCT00168805|141380455|SUPERIORITY_OR_OTHER|||||||0.0385||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.0385
70940097|NCT00168805|141380455|SUPERIORITY_OR_OTHER|||||||0.1414||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.1414
70940098|NCT00168805|141380456|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
71072322|NCT04545567|141653435|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
70940099|NCT00168805|141380456|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
70940100|NCT00168805|141380457|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
70940101|NCT00168805|141380457|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
70940102|NCT00168805|141380459|SUPERIORITY_OR_OTHER|||||||0.8209||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.8209
70940103|NCT00168805|141380459|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
71072323|NCT04545567|141653436|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
71072324|NCT04545567|141653437|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71072325|NCT04545567|141653438|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||||||0.52
71072326|NCT04545567|141653439|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||||||0.28
71072327|NCT04545567|141653440|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.05|TWO_SIDED||||||t-test, 1 sided|||||||0.05
71072328|NCT04545567|141653441|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
71072329|NCT04545567|141653442|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
71072330|NCT04545567|141653443|OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
71072331|NCT04545567|141653444|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
71072332|NCT04545567|141653445|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||||||0.49
71072333|NCT04545567|141653446|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
71072334|NCT03979807|141653447|OTHER||Adjusted Hazard Ratio|1.11|||||TWO_SIDED|95.0|1.06|1.17|||||Cox proportional hazard model. 'Treatment' is the only Independent variable used to estimate the hazard ratios. Umeclidinium/Vilanterol is Reference Group.|||1.17|1.06|
71072335|NCT02754674|141653462|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||0.008
71072336|NCT02754674|141653463|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||>0.05
70853234|NCT04093024|141194785|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|1.03|STANDARD_ERROR_OF_MEAN|3.358||0.7613|TWO_SIDED|95.0|-5.848|7.908|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||7.908|-5.848|0.7613
70940104|NCT00472199|141380475|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|1.0||0.0077||95.0|-4.6|-0.7|||ANCOVA|||Analysis of covariance for changes from baseline with factors treatment and country and using baseline as covariate||-0.7|-4.6|0.0077
70940105|NCT00472199|141380476|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.0010
70940106|NCT00472199|141380477|SUPERIORITY_OR_OTHER|||||||0.0044||95.0|||||Cochran-Mantel-Haenszel|||||||0.0044
70940107|NCT00472199|141380478|SUPERIORITY_OR_OTHER|||||||0.0011||95.0|||||Cochran-Mantel-Haenszel|||||||0.0011
71072337|NCT02754674|141653464|SUPERIORITY|Student's t-test or the Mann-Whitney U-test was used to analyze intergroup differences. The paired t-test or Wilcoxon signed rank test was used to analyze differences between pre- and postoperative values. The statistical significance level was set at .05.|||||>|0.05|||||||t-test, 2 sided|||We used the Kolmogorov-Smirnov test to assess the normality of the data distribution. Student's t-test or the Mann-Whitney U-test was used to analyze intergroup differences. The paired t-test or Wilcoxon signed rank test was used to analyze differences between pre- and postoperative values. Pearson's Chi-square test or Fisher's exact test was used to analyze categorical variables between groups. The statistical significance level was set at .05.||||>0.05
71072338|NCT02754674|141653465|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71072339|NCT02754674|141653466|SUPERIORITY|||||||0.054|||||||t-test, 2 sided|||||||0.054
71072340|NCT02419612|141653467|SUPERIORITY||Least Squares (LS) Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.57|-0.18|||Mixed Models Analysis|Adjusted for for treatment, baseline HbA1c, visit, treatment-by-visit interaction, and baseline HbA1c-by-visit interaction.||||-0.18|-0.57|<0.001
71072341|NCT02419612|141653468|SUPERIORITY||LS Mean Difference|-4.06|STANDARD_ERROR_OF_MEAN|0.397|<|0.001|TWO_SIDED|95.0|-4.84|-3.28|||Mixed Models Analysis|Adjusted for for treatment, baseline body weight, visit, treatment-by-visit interaction, and baseline body weight-by-visit interaction.||||-3.28|-4.84|<0.001
71072342|NCT02419612|141653469|SUPERIORITY||Odds Ratio (OR)|1.5||||0.044||95.0|1.01|2.29|||Regression, Logistic|Adjusted for baseline HbA1c value||||2.29|1.01|0.044
71072343|NCT02419612|141653470|SUPERIORITY||LS Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|1.35||0.007|TWO_SIDED|95.0|-6.3|-1.0|||Mixed Models Analysis|Adjusted for treatment, baseline SBP, visit, treatment-by-visit interaction, and baseline SBP-by-visit interaction||||-1.0|-6.3|0.007
70940108|NCT00472199|141380479|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0||||0.0489||95.0|-1.1|-0.9|||Wilcoxon (Mann-Whitney)|||||-0.9|-1.1|0.0489
70940109|NCT00472199|141380480|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0315|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.0|0.0315
71072344|NCT02419612|141653471|SUPERIORITY||Hazard Ratio (HR)|0.15||||0.002|TWO_SIDED|95.0|0.04|0.5||This endpoint did not meet the required number of events (n=10) in each treatment arm, hence was excluded from sequential testing.|Regression, Cox Proportional Hazards|||Time to treatment intensification was analyzed using a Cox proportional hazards model.||0.50|0.04|0.002
71072345|NCT02419612|141653472|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.39|0.68|||Regression, Cox Proportional Hazards|||Time to treatment intensification was analyzed using a Cox proportional hazards model.||0.68|0.39|<0.001
71072346|NCT02419612|141653473|SUPERIORITY||Odds Ratio (OR)|2.1|STANDARD_ERROR_OF_MEAN|0.54||0.006|TWO_SIDED|95.0|1.23|3.42|||Regression, Logistic|Adjusted for baseline HbA1c value.||||3.42|1.23|0.006
71072347|NCT02419612|141653474|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.39|0.68|||Regression, Cox Proportional Hazards|||||0.68|0.39|<0.001
71072348|NCT02135107|141653485|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|P-value was calculated using chi-square test at two-sided significance level of alpha = 0.05.||||||<0.001
71072349|NCT02135107|141653486|SUPERIORITY||||||<|0.001|||||||Chi-squared|P-value was calculated using chi-square test at a two-sided significance level of alpha = 0.05.||Comparison at Week 12||||<0.001
71072350|NCT02135107|141653486|SUPERIORITY||||||<|0.001|||||||Chi-squared|P-value was calculated using chi-square test at two-sided significance level of alpha = 0.05.||Comparison at Week 24||||<0.001
71072351|NCT02135107|141653487|SUPERIORITY||Hazard Ratio (HR)|0.34|||<|0.001|TWO_SIDED|95.0|0.23|0.49|||Log Rank|||||0.49|0.23|<0.001
70940110|NCT00472199|141380481|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0735|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.0|0.0735
70940111|NCT00472199|141380482|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.841|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.0|0.8410
70940112|NCT00472199|141380483|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.9241|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.0|0.9241
70940113|NCT00472199|141380484|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.8093|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.0|0.8093
70940114|NCT00472199|141380485|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0583|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.0|0.0583
71072352|NCT02135107|141653488|SUPERIORITY||Group difference|-15.2|||<|0.001|TWO_SIDED|95.0|-23.5|-6.8|||Chi-squared|P-value was calculated using chi-square test at two-sided significance level of alpha = 0.05.|Group difference (percentage of participants) = Arm D (percentage of participants) - Arm C (percentage of participants) 95% CI was calculated based on normal approximation.|||-6.8|-23.5|<0.001
71072353|NCT02135107|141653491|SUPERIORITY||Group difference|0.0|||=|0.992|TWO_SIDED|95.0|-3.5|3.5||P-value was calculated using chi-square test at two-sided significance level of alpha = 0.05.|Chi-squared||Group difference (percentage of participants) = Arm D (percentage of participants) - Arm C (percentage of participants) 95% CI was calculated based on normal approximation.|||3.5|-3.5|=0.992
71078667|NCT06010732|141665270|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.647|TWO_SIDED|95.0|-2.95|1.84||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Test-Positive Control|||1.84|-2.95|0.647
70853235|NCT04093024|141194786|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|5.049||0.9468|TWO_SIDED|95.0|-10.026|10.707|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||10.707|-10.026|0.9468
70853236|NCT04093024|141194787|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|2.31|STANDARD_ERROR_OF_MEAN|1.33||0.0908|TWO_SIDED|95.0|-0.39|5.02|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||5.02|-0.39|0.0908
70853237|NCT04093024|141194788|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|2.28|STANDARD_ERROR_OF_MEAN|1.39||0.1222|TWO_SIDED|95.0|-0.69|5.25|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||5.25|-0.69|0.1222
70853238|NCT04093024|141194789|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|7.2|STANDARD_ERROR_OF_MEAN|28.2||0.8012|TWO_SIDED|95.0|-50.7|65.0|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||65.0|-50.7|0.8012
71072354|NCT00474045|141653494|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority can only be declared if the non-inferiority criterion was fulfilled for both (FAS and Per-protocol) analysis sets. Non-inferiority was declared if the upper limit of the two-sided 95% CI for the estimated treatment difference was below 0.4%.|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.074||0.4||95.0|-0.21|0.08||P-value for superiority was calculated.|Regression, Linear|Treatment, country, pregnancy (preg.) status at randomisation (random.)-fixed. HbA1c at rand.(covariate) \& at rand. by preg. status (interaction)|Estimated treatment differences for IDet versus NPH at Visit P4 with the corresponding 95% confidence interval (CI) was calculated. Non-inferiority was established but superiority was not established.|Non-inferiority analysis with a null hypothesis stated that the difference between treatments, IDet-NPH, was equal to or larger than the pre-specified non-inferiority margin of 0.4%. In case non-inferiority was established it was also investigated if IDet was superior to NPH with a null hypothesis stating that the difference between IDet and NPH treatment groups is equal to or greater than 0.||0.08|-0.21|0.400
71078668|NCT06010732|141665270|SUPERIORITY||Mean Difference (Final Values)|6.35|||<|0.001|TWO_SIDED|95.0|3.95|8.75||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Test-Placebo|||8.75|3.95|<0.001
71072355|NCT00474045|141653495|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority can only be declared if the non-inferiority criterion was fulfilled for both (FAS and Per-protocol) analysis sets. Non-inferiority was declared if the upper limit of the two-sided 95% CI for the estimated treatment difference was below 0.4%.|Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.096||0.122||95.0|-0.34|0.04||P-value for superiority was calculated|Regression, Linear|Treatment, country, preg. status at rand.(fixed factors),HbA1c at rand.(covariate),HbA1c at rand. by preg. status (interaction)|Estimated treatment differences for IDet versus NPH at Visit P4 with the corresponding 95% CI was calculated. Non-inferiority was established but superiority was not established.|Non-inferiority analysis with a null hypothesis stated that the difference between treatments, IDet-NPH, was equal to or larger than the pre-specified non-inferiority margin of 0.4%. In case non-inferiority was established it was also investigated if IDet was superior to NPH with a null hypothesis stating that the difference between IDet and NPH treatment groups is equal to or greater than 0.||0.04|-0.34|0.122
70853239|NCT04093024|141194790|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|-32.9|STANDARD_ERROR_OF_MEAN|33.8||0.3401|TWO_SIDED|95.0|-103.1|37.2|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||37.2|-103.1|0.3401
70853240|NCT00796445|141194803|NON_INFERIORITY|The aim of this analysis was to demonstrate the clinical efficacy in terms of disease-free survival (DFS) of recMAGE-A3 + AS15 ASCI compared to placebo in the overall study population of patients with completely resected stage III cutaneous melanoma with macroscopic lymph node involvement.|Hazard Ratio (HR)|1.013||||0.8566|TWO_SIDED|95.0|0.879|1.169|||Regression, Cox|||At Final analysis (Month 30)||1.169|0.879|0.8566
70853241|NCT00796445|141194803|NON_INFERIORITY|The aim of this analysis was to demonstrate the clinical efficacy in terms of DFS of the recMAGE-A3 + AS15 ASCI compared to placebo in the population presenting the potentially favorable gene expression signature.|Hazard Ratio (HR)|1.111||||0.4821|TWO_SIDED|95.0|0.828|1.491|||Regression, Cox|||At Final analysis (Month 30)||1.491|0.828|0.4821
70853242|NCT00796445|141194803|NON_INFERIORITY|The aim of this analysis was to demonstrate the clinical efficacy in terms of DFS of the recMAGE-A3 + AS15 ASCI compared to placebo in the population without the potentially favorable gene expression signature|Hazard Ratio (HR)|0.915||||0.5375|TWO_SIDED|95.0|0.691|1.212|||Regression, Cox|||At Final analysis (Month 30)||1.212|0.691|0.5375
70853243|NCT00796445|141194804|NON_INFERIORITY|The aim of this analysis was to demonstrate the clinical efficacy in terms of disease-free survival (DFS) of recMAGE-A3 + AS15 ASCI compared to placebo in the overall study population of patients with completely resected stage III cutaneous melanoma with macroscopic lymph node involvement|Hazard Ratio (HR)|1.023||||0.7534|TWO_SIDED|95.0|0.89|1.175|||Regression, Cox|||At Follow-up analysis (up to Year 5)||1.175|0.890|0.7534
70940115|NCT00472199|141380486|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-5.0||||0.0916|TWO_SIDED|95.0|-5.5|-4.5|||Wilcoxon (Mann-Whitney)|||||-4.5|-5.5|0.0916
71072356|NCT02278120|141653587|SUPERIORITY||Hazard Ratio, log|0.553|||<|1e-07|TWO_SIDED|95.0|0.441|0.694|||Log Rank|||||0.694|0.441|<0.0000001
71072357|NCT02278120|141653588|SUPERIORITY||Cox Proportional Hazard|0.712||||0.00973|TWO_SIDED|95.0|0.535|0.948||One-sided stratified log-rank test|Log Rank|||||0.948|0.535|0.00973
71072358|NCT02278120|141653589|SUPERIORITY|||||||0.00098|||||||Cochran-Mantel-Haenszel|||||||0.000980
71072359|NCT02278120|141653590|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|||||||0.002
71114645|NCT01942668|141737381|SUPERIORITY||Mean Difference (Final Values)|-9.63|STANDARD_ERROR_OF_MEAN|3.38||0.005|TWO_SIDED|95.0|-16.27|-2.99||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-2.99|-16.27|0.005
71114646|NCT01942668|141737381|SUPERIORITY||Mean Difference (Final Values)|-11.97|STANDARD_ERROR_OF_MEAN|3.34|<|0.001|TWO_SIDED|95.0|-18.53|-5.41||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.41|-18.53|<0.001
71114647|NCT01942668|141737382|SUPERIORITY||Mean Difference (Final Values)|-17.12|STANDARD_ERROR_OF_MEAN|3.4|<|0.001|TWO_SIDED|95.0|-23.79|-10.44||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-10.44|-23.79|<0.001
71114648|NCT01942668|141737382|SUPERIORITY||Mean Difference (Final Values)|-15.58|STANDARD_ERROR_OF_MEAN|3.34|<|0.001|TWO_SIDED|95.0|-22.15|-9.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-9.01|-22.15|<0.001
71114649|NCT01942668|141737382|SUPERIORITY||Mean Difference (Final Values)|-11.05|STANDARD_ERROR_OF_MEAN|3.36||0.001|TWO_SIDED|95.0|-17.65|-4.44||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.44|-17.65|0.001
70853244|NCT00796445|141194804|NON_INFERIORITY|The aim of this analysis was to demonstrate the clinical efficacy in terms of DFS of the recMAGE-A3 + AS15 ASCI compared to placebo in the population presenting the potentially favorable gene expression signature.|Hazard Ratio (HR)|1.094||||0.5385|TWO_SIDED|95.0|0.821|1.457|||Regression, Cox|||At Follow-up analysis (up to Year 5)||1.457|0.821|0.5385
70853245|NCT00796445|141194804|NON_INFERIORITY|The aim of this analysis was to demonstrate the clinical efficacy in terms of DFS of the recMAGE-A3 + AS15 ASCI compared to placebo in the population without the potentially favorable gene expression signature.|Hazard Ratio (HR)|0.918||||0.5419|TWO_SIDED|95.0|0.698|1.207|||Regression, Cox|||At Follow-up analysis (up to Year 5)||1.207|0.698|0.5419
70853246|NCT00322621|141194822|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 1.5 point on the BPI 24-hour average pain scale.|Mean Difference (Net)|0.35|||<|0.001||97.5|0.35|0.79||Significance level 0.025|t-test, 1 sided|||Null hypothesis is that duloxetine treatment effect on pain reduction in diabetic peripheral neuropathic pain (DPNP) is not maintained, as indicated by an increase of more than 1.5 point on the BPI 24-hour average pain scale. Null hypothesis is rejected at significance level 0.025 if the upper bound of one-sided 97.5% CI is less than or equal to non-inferiority margin of 1.5 point.||0.79|0.35|<0.001
70853247|NCT00322621|141194825|SUPERIORITY_OR_OTHER|||||||0.269||95.0|||||t-test, 2 sided|||||||0.269
70853248|NCT00322621|141194826|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
70853249|NCT00322621|141194827|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||t-test, 2 sided|||||||0.160
70853250|NCT00322621|141194828|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||t-test, 2 sided|||||||0.016
70853251|NCT00322621|141194829|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||t-test, 2 sided|||||||0.075
70853252|NCT00322621|141194830|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
70853253|NCT00322621|141194831|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||t-test, 2 sided|||||||0.026
70853254|NCT00322621|141194832|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||t-test, 2 sided|||||||0.011
70853255|NCT00322621|141194833|SUPERIORITY_OR_OTHER|||||||0.406||95.0|||||t-test, 2 sided|||||||0.406
70853256|NCT00322621|141194834|SUPERIORITY_OR_OTHER|||||||0.021||95.0|||||t-test, 2 sided|||||||0.021
70853257|NCT00322621|141194835|SUPERIORITY_OR_OTHER|||||||0.124||95.0|||||t-test, 2 sided|||||||0.124
70853258|NCT00322621|141194836|SUPERIORITY_OR_OTHER|||||||0.505||95.0|||||t-test, 2 sided|||||||0.505
70853259|NCT00322621|141194837|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||t-test, 2 sided|||||||0.058
70853260|NCT00322621|141194838|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|||||||0.009
70853261|NCT00322621|141194839|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||t-test, 2 sided|||||||0.016
70853262|NCT00322621|141194840|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||t-test, 2 sided|||||||0.022
71072360|NCT02266472|141653600|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% CIs for the ratios (test to reference treatment) of the adjusted gMeans of the primary endpoints, with acceptance range of 80.00 to 125.00 %.|ratio of the adjusted means|99.11|STANDARD_DEVIATION|6.3|<|0.0001|TWO_SIDED|90.0|96.4|101.89|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of empagliflozin was estimated by the adjusted gMean ratio of Fed 10mg+1000mg FDC divided by Fed 10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).|||101.89|96.40|<0.0001
71072361|NCT02266472|141653601|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% confidence intervals (CIs) for the ratios (test to reference treatment) of the adjusted geometric means (gMeans) of the primary endpoints,using an acceptance range of 80.00 to 125.00 %.|ratio of the adjusted means|101.25|STANDARD_DEVIATION|10.7|<|0.0001|TWO_SIDED|90.0|96.54|106.19|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of metformin was estimated by the adjusted gMean ratio of Fed 10mg+1000mg FDC divided by Fed 10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).|||106.19|96.54|<0.0001
71072362|NCT02266472|141653602|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% CIs for the ratios (test to reference treatment) of the adjusted gMeans of the primary endpoints, with acceptance range of 80.00 to 125.00%.|ratio of the adjusted means|99.12|STANDARD_DEVIATION|12.9|<|0.0001|TWO_SIDED|90.0|93.69|104.87|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of empagliflozin was estimated by the adjusted gMean ratio of Fed10mg+1000mg FDC divided by Fed10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).|||104.87|93.69|<0.0001
71078669|NCT06010732|141665270|SUPERIORITY||Mean Difference (Final Values)|6.9|||<|0.001|TWO_SIDED|95.0|4.49|9.31||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Positive Control-Placebo|||9.31|4.49|<0.001
70853263|NCT00322621|141194841|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||t-test, 2 sided|||||||0.550
70853264|NCT00322621|141194842|SUPERIORITY_OR_OTHER|||||||0.752||95.0|||||t-test, 2 sided|||||||0.752
70853265|NCT00322621|141194843|SUPERIORITY_OR_OTHER|||||||0.713||95.0|||||t-test, 2 sided|||||||0.713
70853266|NCT00322621|141194844|SUPERIORITY_OR_OTHER|||||||0.066||95.0|||||t-test, 2 sided|||||||0.066
70853267|NCT00322621|141194845|SUPERIORITY_OR_OTHER|||||||0.711||95.0|||||t-test, 2 sided|||||||0.711
70853268|NCT00322621|141194846|SUPERIORITY_OR_OTHER|||||||0.678||95.0|||||t-test, 2 sided|||||||0.678
70853269|NCT00322621|141194847|SUPERIORITY_OR_OTHER|||||||0.216||95.0|||||t-test, 2 sided|||||||0.216
70853270|NCT00322621|141194848|SUPERIORITY_OR_OTHER|||||||0.113||95.0|||||t-test, 2 sided|||||||0.113
70853271|NCT00322621|141194851|SUPERIORITY_OR_OTHER|||||||0.368||95.0|||||t-test, 2 sided|||||||0.368
70853272|NCT00322621|141194852|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
70853273|NCT00322621|141194853|SUPERIORITY_OR_OTHER|||||||0.666||95.0|||||t-test, 2 sided|||||||0.666
70853274|NCT00322621|141194854|SUPERIORITY_OR_OTHER|||||||0.138||95.0|||||t-test, 2 sided|||||||0.138
70853275|NCT00322621|141194855|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||t-test, 2 sided|||||||0.145
70940116|NCT00472199|141380487|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.5||||0.5905|TWO_SIDED|95.0|2.2|2.8|||Wilcoxon (Mann-Whitney)|||||2.8|2.2|0.5905
70940117|NCT00472199|141380488|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.0||||0.0179|TWO_SIDED|95.0|1.6|2.4|||Wilcoxon (Mann-Whitney)|||||2.4|1.6|0.0179
70940118|NCT00472199|141380489|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.0||||0.545|TWO_SIDED|95.0|1.7|2.3|||Wilcoxon (Mann-Whitney)|||||2.3|1.7|0.5450
70940119|NCT00472199|141380490|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.1456|TWO_SIDED|95.0|-0.3|0.3|||Wilcoxon (Mann-Whitney)|||||0.3|-0.3|0.1456
70940120|NCT00472199|141380491|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.2915|TWO_SIDED|95.0|-0.4|0.4|||Wilcoxon (Mann-Whitney)|||||0.4|-0.4|0.2915
70940121|NCT00472199|141380492|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.3131|TWO_SIDED|95.0|-0.4|0.4|||Wilcoxon (Mann-Whitney)|||||0.4|-0.4|0.3131
70940122|NCT00472199|141380493|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.5713|TWO_SIDED|95.0|-0.4|0.4|||Wilcoxon (Mann-Whitney)|||||0.4|-0.4|0.5713
70940123|NCT00472199|141380494|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.8432|TWO_SIDED|95.0|-0.4|0.4|||Wilcoxon (Mann-Whitney)|||||0.4|-0.4|0.8432
70940124|NCT00472199|141380495|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|6.3||||0.0206|TWO_SIDED|95.0|5.9|6.6|||Wilcoxon (Mann-Whitney)|||||6.6|5.9|0.0206
70940125|NCT00472199|141380496|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.6||||0.5602|TWO_SIDED|95.0|0.4|0.8|||Wilcoxon (Mann-Whitney)|||||0.8|0.4|0.5602
71072363|NCT02266472|141653603|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% CIs for the ratios (test to reference treatment) of the adjusted gMeans of the primary endpoints, with acceptance range of 80.00 to 125.00%.|ratio of the adjusted means|108.58|STANDARD_DEVIATION|9.3|<|0.0001|TWO_SIDED|90.0|104.17|113.17|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of metformin was estimated by the adjusted gMean ratio of Fed10mg+1000mg FDC divided by Fed10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).|||113.17|104.17|<0.0001
71072364|NCT02266472|141653604|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% CIs for the ratios (test to reference treatment) of the adjusted gMeans of the primary endpoints, with acceptance range of 80.00 to 125.00%.|ratio of the adjusted means|98.89|STANDARD_DEVIATION|6.3|||TWO_SIDED|90.0|96.18|101.67|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of empagliflozin was estimated by the adjusted gMean ratio of Fed10mg+1000mg FDC divided by Fed10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).|||101.67|96.18|
70940126|NCT00472199|141380497|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.0||||0.136|TWO_SIDED|95.0|0.8|1.1|||Wilcoxon (Mann-Whitney)|||||1.1|0.8|0.1360
71072365|NCT02266472|141653605|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% CIs for the ratios (test to reference treatment) of the adjusted gMeans of the primary endpoints, with acceptance range of 80.00 to 125.00%.|ratio of the adjusted means|101.37|STANDARD_DEVIATION|11.0|||TWO_SIDED|90.0|96.53|106.45|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of metformin was estimated by the adjusted gMean ratio of Fed10mg+1000mg FDC divided by Fed10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).|||106.45|96.53|
71078670|NCT04401202|141665271|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
70940127|NCT00472199|141380499|SUPERIORITY_OR_OTHER|||||||0.0022||95.0|||||Mantel Haenszel|||||||0.0022
70940128|NCT02446912|141380511|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|-4.2||||0.412|TWO_SIDED|95.0|-14.2|5.8||Nominal p-value|Cochran-Mantel-Haenszel|||||5.8|-14.2|0.412
70940129|NCT02446912|141380511|SUPERIORITY||Mean Difference (Final Values)|-2.6|||||TWO_SIDED|95.0|-14.7|9.6||||||||9.6|-14.7|
70940130|NCT02446912|141380512|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|3.9||||0.455|TWO_SIDED|95.0|-6.3|14.1||Nominal p-value|Cochran-Mantel-Haenszel|||||14.1|-6.3|0.455
70940131|NCT02446912|141380512|SUPERIORITY||Mean Difference (Final Values)|5.5|||||TWO_SIDED|95.0|-6.7|17.8||||||||17.8|-6.7|
70940132|NCT02446912|141380513|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|-3.4||||0.549|TWO_SIDED|95.0|-14.4|7.6||Nominal p-value|Cochran-Mantel-Haenszel|||||7.6|-14.4|0.549
70940133|NCT02446912|141380514|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|6.4||||0.261|TWO_SIDED|95.0|-4.8|17.7||Nominal p-value|Cochran-Mantel-Haenszel|||||17.7|-4.8|0.261
70940134|NCT02446912|141380515|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|8.9||||0.18|TWO_SIDED|95.0|-4.1|21.9||Nominal p-value|Cochran-Mantel-Haenszel|||||21.9|-4.1|0.180
71114650|NCT01942668|141737382|SUPERIORITY||Mean Difference (Final Values)|-13.02|STANDARD_ERROR_OF_MEAN|3.32|<|0.001|TWO_SIDED|95.0|-19.54|-6.5||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.50|-19.54|<0.001
71114651|NCT01942668|141737383|SUPERIORITY||Mean Difference (Final Values)|-16.8|STANDARD_ERROR_OF_MEAN|3.45|<|0.001|TWO_SIDED|95.0|-23.58|-10.03||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-10.03|-23.58|<0.001
71114652|NCT01942668|141737383|SUPERIORITY||Mean Difference (Final Values)|-15.66|STANDARD_ERROR_OF_MEAN|3.4|<|0.001|TWO_SIDED|95.0|-22.32|-8.99||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-8.99|-22.32|<0.001
70853276|NCT00322621|141194856|SUPERIORITY_OR_OTHER|||||||0.512||95.0|||||t-test, 2 sided|||||||0.512
70940135|NCT02446912|141380516|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|16.7||||0.013|TWO_SIDED|95.0|3.5|29.8||Nominal p-value|Cochran-Mantel-Haenszel|||||29.8|3.5|0.013
71114653|NCT01942668|141737383|SUPERIORITY||Mean Difference (Final Values)|-11.2|STANDARD_ERROR_OF_MEAN|3.41||0.001|TWO_SIDED|95.0|-17.9|-4.49||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.49|-17.90|0.001
71114654|NCT01942668|141737383|SUPERIORITY||Mean Difference (Final Values)|-12.16|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-18.78|-5.55||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.55|-18.78|<0.001
71114655|NCT01942668|141737384|SUPERIORITY||Mean Difference (Final Values)|-18.11|STANDARD_ERROR_OF_MEAN|3.47|<|0.001|TWO_SIDED|95.0|-24.92|-11.29||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-11.29|-24.92|<0.001
70940136|NCT02446912|141380517|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|17.0||||0.054|TWO_SIDED|95.0|-0.3|34.3||Nominal p-value|Cochran-Mantel-Haenszel|||||34.3|-0.3|0.054
70940137|NCT02446912|141380518|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|18.7||||0.034|TWO_SIDED|95.0|1.4|36.0||Nominal p-value|Cochran-Mantel-Haenszel|||||36.0|1.4|0.034
70853277|NCT01743001|141194863|SUPERIORITY||least-square (LS) mean difference|-4.7||||0.612|TWO_SIDED|95.0|-22.8|13.5||To control for multiplicity across the primary and secondary endpoints, all secondary endpoints were analyzed hierarchically according to order and significance as pre-specified in the protocol eliminating further adjustment for multiple comparisons.|ANCOVA|ANCOVA model included treatment group, presence of DS (yes/no), and WHO FC (II vs III/IV) as categorical factors, and baseline 6MWD value as covariate||The null hypothesis was that there was no difference between macitentan and placebo for the mean change from baseline to Week 16 in 6MWD. Null hypothesis was tested by an analysis of covariance (ANCOVA).||13.5|-22.8|0.6120
70940138|NCT02446912|141380519|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|0.6||||0.905|TWO_SIDED|95.0|-9.4|10.6||Nominal p-value|Cochran-Mantel-Haenszel|||||10.6|-9.4|0.905
71072366|NCT00808639|141653606|SUPERIORITY_OR_OTHER||Pathologic response rate|49.0|||||TWO_SIDED|80.0|38.0|61.0||||||This study used a Simon's optimal two-stage design. Of 39 eligible patients, if 18 achieved PaR, the treatment would be declared effective. A two-sided 80% CI was estimated considering the two-stage design based on Atkinson and Brown methods.||61|38|
71072367|NCT01187498|141653609|NON_INFERIORITY_OR_EQUIVALENCE|A power analysis indicated that a sample size of 70 per group would provide 80% power with a one-sided alpha of 0.05 to declare two means equivalent, assuming a mean voiding frequency of 8.2 for behavioral treatment, a mean voiding frequency of 8.0 for drug therapy, and a standard deviation of 2.3 for both groups. Equivalence was defined as ±15% of the drug therapy posttreatment mean.|Difference of the Means|0.4|STANDARD_ERROR_OF_MEAN|0.346||0.001||95.0|||||Regression, Linear||The estimated parameter of dispersion is the standard error of the regression coefficient which measured the adjusted difference of the group means.|The primary analysis was an equivalence analysis to compare the two treatment groups on posttreatment 24- hour voiding frequency using a margin of ±15% of the drug group mean. Schuirmann's two one-sided tests (TOST) approach was used first to examine completers and then repeated using last observation carried forward to include participants who did not complete therapy. Adjusting the test to regression, the analyses were repeated using baseline voiding frequency as a covariate.||||.001
71072368|NCT01187498|141653610|SUPERIORITY_OR_OTHER||Difference of the Means|-0.38|STANDARD_ERROR_OF_MEAN|0.188||0.05||95.0|||||Regression, Linear||The estimated parameter of dispersion represents the standard error for the difference of the group means.|Standard regression methods adjusting for baseline values||||.05
71072369|NCT01187498|141653611|SUPERIORITY_OR_OTHER||Difference of Group Means|0.19|STANDARD_ERROR_OF_MEAN|0.091||0.05||95.0|||||t-test, 2 sided||The estimated parameter of dispersion represents the standard error for the difference of the group means.|Standard regression methods adjusting for baseline values||||.05
71072370|NCT01187498|141653612|SUPERIORITY_OR_OTHER||Difference in Group Means|-0.14|STANDARD_ERROR_OF_MEAN|0.091||0.33||95.0|||||t-test, 2 sided||The estimated parameter of dispersion represents the standard error for the difference of the group means.|Standard regression methods adjusting for baseline values||||.33
71072371|NCT01187498|141653613|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.924||0.84||95.0|||||t-test, 2 sided||The estimated parameter of dispersion represents the standard error for the difference of the group means.|Standard regression methods adjusting for baseline values||||.84
71072372|NCT01187498|141653614|SUPERIORITY_OR_OTHER||Difference in Weighted Group Means|-0.0563|STANDARD_ERROR_OF_MEAN|0.1249||0.69||95.0|||||Cochran-Mantel-Haenszel||The estimated parameter of dispersion represents the standard error for the difference of the weighted group means.|Cochran Mantel-Haenszel procedure used to account for the ordinal nature of responses.||||.69
71072373|NCT01187498|141653615|SUPERIORITY_OR_OTHER||Difference between Group Weighted Means|-0.1563|STANDARD_ERROR_OF_MEAN|0.1009||0.16||95.0|||||Cochran-Mantel-Haenszel||The estimated parameter of dispersion represents the standard error for the difference of the weighted group means.|Cochran Mantel-Haenszel procedure used to account for the ordinal nature of responses.||||.16
71072374|NCT01187498|141653616|SUPERIORITY_OR_OTHER||Difference in Weighted Group Means|0.1079|STANDARD_ERROR_OF_MEAN|0.1625||0.56||95.0|||||Cochran-Mantel-Haenszel||The estimated parameter of dispersion represents the standard error for the difference of the weighted group means.|Cochran Mantel-Haenszel procedure used to account for the ordinal nature of responses.||||.56
71072375|NCT01187498|141653617|SUPERIORITY_OR_OTHER||Difference in Weighted Group Means|0.054|STANDARD_ERROR_OF_MEAN|0.1265||0.65||95.0|||||Cochran-Mantel-Haenszel||The estimated parameter of dispersion represents the standard error for the difference of the weighted group means.|Cochran Mantel-Haenszel procedure used to account for the ordinal nature of responses.||||.65
71072376|NCT01187498|141653618|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Cochran-Mantel-Haenszel|||Cochran Mantel-Haenszel procedure used to account for the ordinal nature of responses.||||.01
71072377|NCT01187498|141653619|SUPERIORITY_OR_OTHER||Difference in Group Proportions|-0.21|STANDARD_ERROR_OF_MEAN|0.086||0.02||95.0|||||Chi-squared||The estimated parameter of dispersion represents the standard error for the difference of the group proportions.|Cochran Mantel-Haenszel procedure.||||.02
71078671|NCT03004924|141665292|SUPERIORITY||Difference in response rate|7.7||||0.127|TWO_SIDED|95.0|-1.6|16.9|||Fisher Exact|||||16.9|-1.6|0.127
71078672|NCT03004924|141665293|SUPERIORITY||Difference in response rate|-3.5||||0.5|TWO_SIDED|95.0|-12.8|5.9|||Fisher Exact|||||5.9|-12.8|0.500
70853278|NCT01743001|141194864|SUPERIORITY||Odds Ratio (OR)|0.53||||0.145|TWO_SIDED|95.0|0.23|1.24||The secondary efficacy endpoints were analyzed hierarchically as this approach eliminated the requirement for further adjustment for multiple comparisons.|Regression, Logistic|Logistic regression model adjusted for randomized treatment group and location of cardiac defect (pre-tricupsid / post-tricupsid ) as factors.||For this secondary endpoint of WHO functional class, the improvement from baseline to Week 16 in WHO functional class was evaluated. The null hypothesis is the odds of improvement are the same in the placebo and the macitentan group.||1.24|0.23|0.1450
71072378|NCT00191282|141653624|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.866||95.0|||||Log Rank|||To achieve 80% power, 490 pts need to experience primary combined CV outcome to detect diff. between treatments, assuming: \>=18.5% reduction in incidence of outcomes, 18 mo. pt recruitment, 18 mo. pt follow-up, 10% annual drop-out rate, 2-yr outcome incidence rate of \>=40% (pts in least efficacious treatment), and nominal 2-sided signif. of 0.045.||||0.866
71072379|NCT00191282|141653625|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.715||95.0|||||Log Rank|||||||0.715
71072380|NCT00191282|141653626|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.914||95.0|||||Log Rank|||||||0.914
71072381|NCT00191282|141653627|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.706||95.0|||||Log Rank|||||||0.706
71072382|NCT00191282|141653628|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.982||95.0|||||Log Rank|||||||0.982
71072383|NCT00191282|141653629|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.816||95.0|||||Log Rank|||||||0.816
71072384|NCT00191282|141653630|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.948||95.0|||||Log Rank|||||||0.948
71072385|NCT00191282|141653631|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.581||95.0|||||Log Rank|||||||0.581
71072386|NCT00191282|141653632|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.647||95.0|||||Log Rank|||||||0.647
71072387|NCT00191282|141653633|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.525||95.0|||||Log Rank|||||||0.525
71072388|NCT00191282|141653634|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.8||95.0|||||Log Rank|||||||0.800
71072389|NCT00191282|141653635|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.662||95.0|||||Log Rank|||||||0.662
71072390|NCT00191282|141653636|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.863||95.0|||||Log Rank|||||||0.863
71072391|NCT00191282|141653637|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.471||95.0|||||Log Rank|||||||0.471
71072392|NCT00191282|141653638|SUPERIORITY_OR_OTHER|||||||0.7168||95.0|||||Chi-squared|||||||0.7168
71072393|NCT00191282|141653640|SUPERIORITY_OR_OTHER|||||||0.086||95.0|||||Chi-squared|||||||0.0860
71072394|NCT00191282|141653642|SUPERIORITY_OR_OTHER|||||||0.1424||95.0|||||Chi-squared|||||||0.1424
71072395|NCT00191282|141653645|SUPERIORITY_OR_OTHER|||||||0.1957||95.0|||||Chi-squared|||||||0.1957
71072396|NCT00191282|141653647|SUPERIORITY_OR_OTHER|||||||0.2434||95.0|||||Chi-squared|||||||0.2434
71072397|NCT00191282|141653649|SUPERIORITY_OR_OTHER|||||||0.2617||95.0|||||Chi-squared|||||||0.2617
71072398|NCT01726036|141653754|SUPERIORITY_OR_OTHER|||||||0.457|||||||Wilcoxon (Mann-Whitney)|||||||0.457
71072399|NCT03055494|141653760|OTHER|Statistical hypothesis tests were not performed in this study|difference in percentages|76.1|||||TWO_SIDED|95.0|63.3|88.8|||95% confidence interval|"Statistical analysis of no response of skin histology/K16 expression to treatment at Week 12"|||"A patient with missing assessment was considered as having a yes response of skin histology/K16 expression to treatment regardless of the reason for missing data (eg, premature study discontinuation, missed visit, administrative issues). However, missing baseline value was not imputed."|88.8|63.3|
71072400|NCT03055494|141653761|OTHER|Statistical hypothesis tests were not performed in this study|difference in percentages|55.8|||||TWO_SIDED|95.0|42.3|69.3|||95% confidence interval|||||69.3|42.3|
71072401|NCT05897827|141653778|OTHER|We calculated the mean and 95% confidence interval using a one sample two-sided t-test against the a priori benchmark of success, which was \> 3.75.|Mean|3.93||||0.074|TWO_SIDED|95.0|3.73|4.13||Threshold for statistical significance: \<0.05|t-test, 2 sided|||||4.13|3.73|0.074
71072402|NCT05897827|141653779|OTHER|We calculated the mean and 95% confidence interval using a one sample two-sided t-test against the a priori benchmark of success, which was \> 75.|Mean|75.47||||0.827|TWO_SIDED|95.0|71.12|79.83||Threshold for statistical significance: \<0.05|t-test, 2 sided|||||79.83|71.12|0.827
71072403|NCT05897827|141653780|OTHER|We calculated the mean and 95% confidence interval using a one sample two-sided t-test against the a priori benchmark of success, which was \> 3.75.|Mean|4.01||||0.003|TWO_SIDED|95.0|3.84|4.17||Threshold for statistical significance: \<0.05|t-test, 2 sided|||||4.17|3.84|0.003
71072404|NCT05897827|141653781|OTHER|We calculated the mean and 95% confidence interval using a one sample two-sided t-test against the a priori benchmark of success, which was \> 3.75.|Mean|4.01||||0.002|TWO_SIDED|95.0|3.85|4.18||Threshold for statistical significance: \<0.05|t-test, 2 sided|||||4.18|3.85|0.002
71072405|NCT05897827|141653785|OTHER|To test for within-arm statistical significance, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.22||||0.03|TWO_SIDED|95.0|0.03|0.42||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.42|0.03|0.03
71072406|NCT05897827|141653785|OTHER|To test for within-arm statistical significance, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.01||||0.95|TWO_SIDED|95.0|-0.36|0.38||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.38|-0.36|0.95
71072407|NCT05897827|141653786|OTHER|To test for within-arm statistical significance of the change in Self-Efficacy in LGBTQ+ Inclusivity, Awareness, and Advocacy, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.7|||<|0.001|TWO_SIDED|95.0|0.46|0.95||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.95|0.46|<0.001
71072408|NCT05897827|141653786|OTHER|To test for within-arm statistical significance of the change in Self-Efficacy in LGBTQ+ Inclusivity, Awareness, and Advocacy, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.45||||0.01|TWO_SIDED|95.0|0.1|0.8||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.80|0.10|0.01
70853279|NCT01743001|141194865|SUPERIORITY||least-square (LS) mean difference|0.08||||0.6818||95.0|-0.29|0.44||The secondary efficacy endpoints were analyzed hierarchically as this approach eliminated the requirement for further adjustment for multiple comparisons.|ANCOVA|Adjusted for randomized treatment group, location of cardiac defect(pre-tricupsid/post-tricupsid) as factors, baseline Borg dyspnea index as covariate||The null hypothesis was that the mean change from baseline to Week 16 in the Borg dyspnea index is the same in the macitentan and in the placebo group.||0.44|-0.29|0.6818
71072409|NCT05897827|141653786|OTHER|To test for within-arm statistical significance of the change in Self-Efficacy in Identity-Affirming Practices, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.26||||0.001|TWO_SIDED|95.0|0.11|0.41||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.41|0.11|0.001
71072410|NCT05897827|141653786|OTHER|To test for within-arm statistical significance of the change in Self-Efficacy in Identity-Affirming Practices, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.13||||0.01|TWO_SIDED|95.0|0.03|0.24||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.24|0.03|0.01
71072411|NCT05897827|141653786|OTHER|To test for within-arm statistical significance of the change in Self-Efficacy in Inclusivity in Restrooms and Changing Options, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.43||||0.001|TWO_SIDED|95.0|0.18|0.68||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.68|0.18|0.001
71072412|NCT05897827|141653786|OTHER|To test for within-arm statistical significance of the change in Self-Efficacy in Inclusivity in Restrooms and Changing Options, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.44||||0.04|TWO_SIDED|95.0|0.02|0.86||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.86|0.02|0.04
71072413|NCT05897827|141653787|OTHER|To test for within-arm statistical significance of the change in Notice the Event, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.23||||0.1|TWO_SIDED|95.0|-0.5|0.04||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.04|-0.50|0.10
71072414|NCT05897827|141653787|OTHER|To test for within-arm statistical significance of the change in Notice the Event, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.24||||0.14|TWO_SIDED|95.0|-0.55|0.07||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.07|-0.55|0.14
71072415|NCT05897827|141653787|OTHER|To test for within-arm statistical significance of the change in Interpret the Event as an Emergency, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.19||||0.07|TWO_SIDED|95.0|-0.39|0.01||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.01|-0.39|0.07
71072416|NCT05897827|141653787|OTHER|To test for within-arm statistical significance of the change in Interpret the Event as an Emergency, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.02||||0.85|TWO_SIDED|95.0|-0.18|0.22||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.22|-0.18|0.85
71072417|NCT05897827|141653787|OTHER|To test for within-arm statistical significance of the change in Accept Responsibility for Intervening, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.15||||0.06|TWO_SIDED|95.0|-0.3|0.01||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.01|-0.30|0.06
71072418|NCT05897827|141653787|OTHER|To test for within-arm statistical significance of the change in Accept Responsibility for Intervening, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.07||||0.51|TWO_SIDED|95.0|-0.14|0.28||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.28|-0.14|0.51
71072419|NCT05897827|141653787|OTHER|To test for within-arm statistical significance of the change in Know How to Intervene, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.33||||0.001|TWO_SIDED|95.0|0.13|0.53||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.53|0.13|0.001
71072420|NCT05897827|141653787|OTHER|To test for within-arm statistical significance of the change in Know How to Intervene, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.28||||0.04|TWO_SIDED|95.0|0.01|0.55||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.55|0.01|0.04
71072421|NCT05897827|141653787|OTHER|To test for within-arm statistical significance of the change in Implement Intervention Decisions, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.06||||0.36|TWO_SIDED|95.0|-0.19|0.07||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.07|-0.19|0.36
71072422|NCT05897827|141653787|OTHER|To test for within-arm statistical significance of the change in Implement Intervention Decisions, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.03||||0.62|TWO_SIDED|95.0|-0.16|0.1||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.10|-0.16|0.62
71072423|NCT05897827|141653788|OTHER|To test for within-arm statistical significance of the change in Notice the Event, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.15||||0.08|TWO_SIDED|95.0|-0.32|0.02||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.02|-0.32|0.08
71114656|NCT01942668|141737384|SUPERIORITY||Mean Difference (Final Values)|-16.45|STANDARD_ERROR_OF_MEAN|3.42|<|0.001|TWO_SIDED|95.0|-23.17|-9.74||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-9.74|-23.17|<0.001
70940139|NCT02446912|141380520|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|3.3||||0.515|TWO_SIDED|95.0|-6.7|13.4||Nominal p-value|Cochran-Mantel-Haenszel|||||13.4|-6.7|0.515
70940140|NCT02446912|141380521|SUPERIORITY|Analysed using a negative binomial regression model. The response variable in the model is the number of flares over the 52-week treatment period. The model includes covariates of treatment group, and the stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>=10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]). The logarithm of the follow-up time is used as an offset variable.|Rate Ratio|0.83||||0.258|TWO_SIDED|95.0|0.6|1.14||Nominal p-value|Negative binomial regression|||||1.14|0.60|0.258
70940141|NCT02446912|141380522|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|10.1|||||TWO_SIDED|95.0|0.6|19.7|||Cochran-Mantel-Haenszel|||||19.7|0.6|
70940142|NCT02446912|141380523|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|16.4|||||TWO_SIDED|95.0|6.7|26.2|||Cochran-Mantel-Haenszel|||||26.2|6.7|
70940143|NCT00147745|141380539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.07||0.5499||95.0|-0.1|0.19|||ANCOVA|||||0.19|-0.10|0.5499
70940144|NCT00147745|141380539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.09||0.5723||95.0|-0.23|0.13|||ANCOVA|||||0.13|-0.23|0.5723
70940145|NCT00147745|141380539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.091||0.3138||95.0|-0.09|0.28|||ANCOVA|||||0.28|-0.09|0.3138
70940146|NCT00147745|141380540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.065||0.2042||95.0|-0.05|0.22|||ANCOVA|||||0.22|-0.05|0.2042
70940147|NCT00147745|141380540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.083||0.6855||95.0|-0.2|0.14|||ANCOVA|||||0.14|-0.20|0.6855
70853280|NCT01743001|141194866|SUPERIORITY||least-square (LS) mean difference|-1.0||||0.6431|TWO_SIDED|95.0|-5.0|3.1|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Physical Functioning.||3.1|-5.0|0.6431
70940148|NCT00147745|141380540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.085||0.1727||95.0|-0.05|0.29|||ANCOVA|||||0.29|-0.05|0.1727
70940149|NCT00147745|141380541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.4|STANDARD_ERROR_OF_MEAN|53.17||0.4104||95.0|-152.8|64.1|||ANCOVA|||||64.1|-152.8|0.4104
70940150|NCT00147745|141380541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.1|STANDARD_ERROR_OF_MEAN|69.98||0.8857||95.0|-132.6|152.9|||ANCOVA|||||152.9|-132.6|0.8857
70940151|NCT00147745|141380541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-54.5|STANDARD_ERROR_OF_MEAN|67.08||0.4226||95.0|-191.3|82.3|||ANCOVA|||||82.3|-191.3|0.4226
70940152|NCT00147745|141380542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.366||0.2286||95.0|-1.2|0.3|||ANCOVA|||||0.30|-1.20|0.2286
70940153|NCT00147745|141380542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.515||0.3184||95.0|-0.53|1.57|||ANCOVA|||||1.57|-0.53|0.3184
70940154|NCT00147745|141380542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.5||0.0613||95.0|-1.99|0.05|||ANCOVA|||||0.05|-1.99|0.0613
70940155|NCT00147745|141380543|SUPERIORITY_OR_OTHER|||||||0.0362||95.0|||||t-test, 2 sided|||||||0.0362
70940156|NCT02342275|141380599|NON_INFERIORITY|Assuming that the atenolol on the propranolol response rate does not fall by greater than 15%, the noninferiority margin was selected to be -15%.|Odds Ratio (OR)|0.15|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis||Treatment Difference=Propranolol vs Atenolol|The sample size required to compare propranolol and atenolol at month 6 was calculated before enrollment. Assuming the ulceration rate in both groups to be 10%, a sample size of180 patients was required for each group to show the noninferiority ofatenolol treatment with a 2-sidedα level of .05 and approximately 90% power||||<0.05
70940157|NCT04908800|141380607|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.88|||||TWO_SIDED|90.0|1.74|2.04|||||"Data were analyzed using a mixed model which included actual treatment as fixed effect and participant as a random effect.~Within-subject coefficient of variation was 10.7."|||2.04|1.74|
70940158|NCT04908800|141380608|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.68|||||TWO_SIDED|90.0|1.57|1.79|||||"Data were analyzed using a mixed model which included actual treatment as fixed effect and participant as a random effect.~Within-subject coefficient of variation was 9.01."|||1.79|1.57|
71078673|NCT02033200|141665309|SUPERIORITY_OR_OTHER||LS mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.335||0.8216|TWO_SIDED|95.0|-0.592|0.744|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the right eye.||0.744|-0.592|0.8216
71078674|NCT02033200|141665309|SUPERIORITY_OR_OTHER||LS means difference|0.257|STANDARD_ERROR_OF_MEAN|0.258||0.324|TWO_SIDED|95.0|-0.258|0.771|||ANCOVA|||The sample size had adequate power to detect a meaningful difference between treatment groups in the left eye.||0.771|-0.258|0.324
71078675|NCT02033200|141665310|SUPERIORITY_OR_OTHER||LS means difference|0.004|STANDARD_ERROR_OF_MEAN|0.014||0.7864|TWO_SIDED|95.0|-0.024|0.031|||ANCOVA|||The sample size provided enough power to detect any meaningful difference between the two treatment groups in the right eye.||0.031|-0.024|0.7864
70853281|NCT01743001|141194866|SUPERIORITY||least-square (LS) mean difference|-1.4||||0.5988|TWO_SIDED|95.0|-6.7|3.9|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Role-Physical.||3.9|-6.7|0.5988
71072424|NCT05897827|141653788|OTHER|To test for within-arm statistical significance of the change in Notice the Event, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.21||||0.2|TWO_SIDED|95.0|-0.55|0.12||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.12|-0.55|0.20
71078676|NCT02033200|141665310|SUPERIORITY_OR_OTHER||LS Means difference|-0.022|STANDARD_ERROR_OF_MEAN|0.017||0.1953|TWO_SIDED|95.0|-0.056|0.012|||ANCOVA|||The sample size provided enough power to detect any meaningful difference between the two treatment groups in the left eye.||0.012|-0.056|0.1953
71078677|NCT02033200|141665311|SUPERIORITY_OR_OTHER||LS means difference|-0.16|STANDARD_ERROR_OF_MEAN|0.061||0.0101|TWO_SIDED|95.0|-0.28|-0.039|||ANCOVA|||The sample size provided enough power to detect any meaningful difference between the two treatment groups in the right eye.||-0.039|-0.280|0.0101
71078678|NCT02033200|141665311|SUPERIORITY_OR_OTHER||LS means difference|-0.087|STANDARD_ERROR_OF_MEAN|0.061||0.1583|TWO_SIDED|95.0|-0.209|0.035|||ANCOVA|||The sample size provided enough power to detect any meaningful difference between the two treatment groups in the left eye.||0.035|-0.209|0.1583
71078679|NCT02033200|141665312|SUPERIORITY_OR_OTHER||LS means difference|-0.031|STANDARD_ERROR_OF_MEAN|0.359||0.9324|TWO_SIDED|95.0|-0.746|0.685|||ANCOVA|||The sample size should provide approximately 90% power to detect a 1.6 mmHg difference in the mean change in Intraocular Pressure between the two treatment groups in the right eye.||0.685|-0.746|0.9324
71078680|NCT02033200|141665312|SUPERIORITY_OR_OTHER||LS means difference|0.751|STANDARD_ERROR_OF_MEAN|0.348||0.0343|TWO_SIDED|95.0|0.057|1.44|||ANCOVA|||The sample size should provide approximately 90% power to detect a 1.6 mmHg difference in the mean change in intraocular pressure between the two treatment groups in the left eye.||1.44|0.057|0.0343
71078681|NCT02033200|141665313|SUPERIORITY_OR_OTHER||LS Means difference|0.017|STANDARD_ERROR_OF_MEAN|0.017||0.3139|TWO_SIDED|95.0|-0.017|0.051|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the right eye.||0.051|-0.017|0.3139
71078682|NCT02033200|141665313|SUPERIORITY_OR_OTHER||LS means difference|-0.002|STANDARD_ERROR_OF_MEAN|0.022||0.9334|TWO_SIDED|95.0|-0.045|0.042|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the left eye.||0.042|-0.045|0.9334
71078683|NCT02033200|141665314|SUPERIORITY_OR_OTHER||LS means difference|0.016|STANDARD_ERROR_OF_MEAN|0.055||0.7723|TWO_SIDED|95.0|-0.093|0.125|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the right eye.||0.125|-0.093|0.7723
71078684|NCT02033200|141665314|SUPERIORITY_OR_OTHER||LS means difference|0.007|STANDARD_ERROR_OF_MEAN|0.058||0.9107|TWO_SIDED|95.0|-0.109|0.122|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the left eye.||0.122|-0.109|0.9107
71078685|NCT02033200|141665315|SUPERIORITY_OR_OTHER||LS Means difference|-0.078|STANDARD_ERROR_OF_MEAN|0.278||0.7787|TWO_SIDED|95.0|-0.632|0.475|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the right eye.||0.475|-0.632|0.7787
71078686|NCT02033200|141665315|SUPERIORITY_OR_OTHER||LS means difference|-0.18|STANDARD_ERROR_OF_MEAN|0.344||0.6013|TWO_SIDED|95.0|-0.865|0.504|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the left eye.||0.504|-0.865|0.6013
71078687|NCT02033200|141665316|SUPERIORITY_OR_OTHER||LS means difference|0.091|STANDARD_ERROR_OF_MEAN|0.4||0.8209|TWO_SIDED|95.0|-0.705|0.887|||ANCOVA|||The sample size should provide approximately 90% power to detect a 1.6 mmHg difference in the mean change in IOP between the two treatment groups in the right eye.||0.887|-0.705|0.8209
71078688|NCT02033200|141665316|SUPERIORITY_OR_OTHER||LS means difference|0.227|STANDARD_ERROR_OF_MEAN|0.33||0.4931|TWO_SIDED|95.0|-0.43|0.884|||ANCOVA|||The sample size should provide approximately 90% power to detect a 1.6 mmHg difference in the mean change in IOP between the two treatment groups in the left eye.||0.884|-0.430|0.4931
71078689|NCT02670382|141665317|SUPERIORITY||mean values, log transformed|||||0.33|||||||Mixed Models Analysis|||||||0.33
71078690|NCT02670382|141665317|SUPERIORITY||mean difference, log transformed values|||||0.92|||||||Mixed Models Analysis|||||||0.92
71078691|NCT02670382|141665317|SUPERIORITY||mean difference, log transformed values|||||0.44|||||||Mixed Models Analysis|||||||0.44
71078692|NCT02670382|141665318|SUPERIORITY||mean difference, log transformed values|||||0.34|||||||Mixed Models Analysis|||||||0.34
71078693|NCT02670382|141665318|SUPERIORITY||mean difference, log transformed values|||||0.5|||||||Mixed Models Analysis|||||||0.50
71078694|NCT02670382|141665318|SUPERIORITY||mean differences, log transformed values|||||0.83|||||||Mixed Models Analysis|||||||0.83
71078695|NCT02670382|141665319|EQUIVALENCE|primary hypothesis is that EPA will not differ from placebo|mean differences|||||0.1|||||||Mixed Models Analysis|||||||0.10
71078696|NCT02670382|141665319|SUPERIORITY||mean difference|||||0.005|||||||Mixed Models Analysis|||||||0.005
71078697|NCT02670382|141665319|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||||||0.17
71078698|NCT03244618|141665320|SUPERIORITY||Mean Difference (Final Values)|-0.544|||<|0.001|TWO_SIDED|95.0|-0.712|-0.377|||ANOVA|ANOVA model had treatment and gender as factors.|Difference is first named toothpaste minus second named toothpaste such that a negative difference favours first named toothpaste.|||-0.377|-0.712|<0.001
70940159|NCT04908800|141380609|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.15|||||TWO_SIDED|90.0|1.09|1.21|||||Data were analyzed using a mixed model which included actual treatment as fixed effect and participant as a random effect. Within-subject coefficient of variation was 7.18.|||1.21|1.09|
71072425|NCT05897827|141653788|OTHER|To test for within-arm statistical significance of the change in Interpret the Event as an Emergency, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.02||||0.74|TWO_SIDED|95.0|-0.14|0.1||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.10|-0.14|0.74
71072426|NCT05897827|141653788|OTHER|To test for within-arm statistical significance of the change in Interpret the Event as an Emergency, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.05||||0.55|TWO_SIDED|95.0|-0.12|0.23||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.23|-0.12|0.55
70853282|NCT01743001|141194866|SUPERIORITY||least-square (LS) mean difference|0.1||||0.9642|TWO_SIDED|95.0|-5.9|6.2|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Pain Index.||6.2|-5.9|0.9642
71072427|NCT05897827|141653788|OTHER|To test for within-arm statistical significance of the change in Accept Responsibility for Intervening, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.07||||0.4|TWO_SIDED|95.0|-0.22|0.09||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.09|-0.22|0.40
71072428|NCT05897827|141653788|OTHER|To test for within-arm statistical significance of the change in Accept Responsibility for Intervening, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.12||||0.36|TWO_SIDED|95.0|-0.37|0.13||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.13|-0.37|0.36
71072429|NCT05897827|141653788|OTHER|To test for within-arm statistical significance of the change in Know How to Intervene, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.39|||<|0.001|TWO_SIDED|95.0|0.18|0.6||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.60|0.18|<0.001
71072430|NCT05897827|141653788|OTHER|To test for within-arm statistical significance of the change in Know How to Intervene, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.12||||0.41|TWO_SIDED|95.0|-0.16|0.39||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.39|-0.16|0.41
71072431|NCT05897827|141653788|OTHER|To test for within-arm statistical significance of the change in Implement Intervention Decisions, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.01||||0.92|TWO_SIDED|95.0|-0.22|0.2||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.20|-0.22|0.92
71072432|NCT05897827|141653788|OTHER|To test for within-arm statistical significance of the change in Implement Intervention Decisions, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.14||||0.37|TWO_SIDED|95.0|-0.16|0.44||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.44|-0.16|0.37
71072433|NCT05897827|141653789|OTHER|To test for within-arm statistical significance, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.44|||<|0.001|TWO_SIDED|95.0|0.28|0.59||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.59|0.28|<0.001
71072434|NCT05897827|141653789|OTHER|To test for within-arm statistical significance, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.49|||<|0.001|TWO_SIDED|95.0|0.29|0.69||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.69|0.29|<0.001
71072435|NCT00197002|141653791|NON_INFERIORITY_OR_EQUIVALENCE|"The two-sided standardized asymptotic 95% confidence interval (CI) for the difference in seropositivity rates \[Havrix+Prevnar Group minus Havrix Group\] was computed. The anti-HAV seropositivity rates in the Havrix+Prevnar Group were considered as non-inferior to the seropositivity rates in the Havrix Group, if the lower limit of the 95% CI was not lower (≥) than -5%.~The non-inferiority was concluded if both non-inferiority criteria (for seropositivity rates and GMCs) were met."|Difference in seropositivity rate|-1.06|||||TWO_SIDED|95.0|-5.78|2.45||||||"Difference in seropositivity rates for anti-HAV:~To demonstrate the non-inferiority of Havrix® vaccine co-administered with Prevnar™ vaccine (Havrix+Prevnar Group), compared to Havrix® vaccine administered alone (Havrix Group), in terms of seropositivity rates and geometric mean concentrations (GMCs) for anti-HAV antibody, one month after Dose 2 of Havrix® vaccine (Month 7-10)."||2.45|-5.78|
71114657|NCT01942668|141737384|SUPERIORITY||Mean Difference (Final Values)|-12.41|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-19.15|-5.66||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.66|-19.15|<0.001
71114658|NCT01942668|141737384|SUPERIORITY||Mean Difference (Final Values)|-13.6|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-20.26|-6.93||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.93|-20.26|<0.001
70853283|NCT01743001|141194866|SUPERIORITY||least-square (LS) mean difference|3.1||||0.1542|TWO_SIDED|95.0|-1.2|7.3|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of General Health Perceptions.||7.3|-1.2|0.1542
71114659|NCT01942668|141737385|SUPERIORITY||Mean Difference (Final Values)|-16.58|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-23.33|-9.82||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-9.82|-23.33|<0.001
71114660|NCT01942668|141737385|SUPERIORITY||Mean Difference (Final Values)|-15.07|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-21.72|-8.42||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-8.42|-21.72|<0.001
70940160|NCT04908800|141380614|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|0.971|||||TWO_SIDED|95.0|0.882|1.06|||||Between-subject geometric coefficient of variation was 26.1. Data were analyzed using a power model.|Dose Proportionality Assessment||1.06|0.882|
70940161|NCT04908800|141380614|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.01|||||TWO_SIDED|95.0|0.926|1.11|||||Geometric least squares mean was 600 (fasted) and 607 (fed). Within-subject coefficient of variation was 6.01. Data were analyzed using mixed model which included actual treatment as fixed effect and participant as a random effect.|Food Effect Assessment||1.11|0.926|
70940162|NCT04908800|141380614|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.06|||||TWO_SIDED|95.0|0.701|1.59|||||Geometric least squares mean was 600 (fasted male) and 634 (fasted female). Between subject coefficient of variation was 32.7. Data were analyzed using an ANOVA model which included actual treatment as a factor.|Sex Effect Assessment||1.59|0.701|
71072436|NCT00197002|141653792|NON_INFERIORITY_OR_EQUIVALENCE|"The standardized two-sided 95% CI for the GMC ratio (Havrix+Prevnar Group divided by Havrix Group) was computed. The anti-HAV GMC in the Havrix+Prevnar Group was considered as non-inferior to the anti-HAV GMC in the Havrix Group if the lower limit of the 95% CI was not lower than (≥) 0.5.~The non-inferiority of the anti-HAV immune response in Havrix+Prevnar Group compared to Havrix Group was concluded if both non-inferiority criteria (for seropositivity rates and GMCs) were met."|Adjusted GMC ratio|0.91|||||TWO_SIDED|95.0|0.63|1.31|||ANCOVA|||To demonstrate the non-inferiority of Havrix® vaccine co-administered with Prevnar™ vaccine (Havrix+Prevnar Group), compared to Havrix® vaccine administered alone (Havrix Group), in terms of seropositivity rates and geometric mean concentrations (GMCs) for anti-HAV antibody, one month after Dose 2 of Havrix® vaccine (Month 7-10).||1.31|0.63|
71114661|NCT01942668|141737385|SUPERIORITY||Mean Difference (Final Values)|-10.79|STANDARD_ERROR_OF_MEAN|3.41||0.002|TWO_SIDED|95.0|-17.48|-4.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.10|-17.48|0.002
71114662|NCT01942668|141737385|SUPERIORITY||Mean Difference (Final Values)|-11.71|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|-18.31|-5.11||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.11|-18.31|<0.001
70853284|NCT01743001|141194866|SUPERIORITY||least-square (LS) mean difference|1.1||||0.602|TWO_SIDED|95.0|-3.1|5.3|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Vitality.||5.3|-3.1|0.6020
71072437|NCT02017717|141653810|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.3791|TWO_SIDED|95.0|0.89|1.36|||log-rank test stratified|||||1.36|0.89|0.3791
71072438|NCT02017717|141653811|SUPERIORITY||Difference of OS rates at 12 months|-0.5||||0.9208|TWO_SIDED|95.0|-10.8|9.7|||Z test with variance estimation based on|Greenwood formula using log(-log) transformation||||9.7|-10.8|0.9208
71072439|NCT02017717|141653813|SUPERIORITY||Hazard Ratio (HR)|1.88|||||TWO_SIDED|95.0|1.5|2.35||||||||2.35|1.50|
71114663|NCT01942668|141737386|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.034||0.801|TWO_SIDED|95.0|-0.06|0.08||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.08|-0.06|0.801
71114664|NCT01942668|141737386|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.034||0.991|TWO_SIDED|95.0|-0.07|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.07|-0.07|0.991
71114665|NCT01942668|141737386|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.034||0.642|TWO_SIDED|95.0|-0.05|0.08||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.08|-0.05|0.642
70940163|NCT04908800|141380615|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|0.977|||||TWO_SIDED|95.0|0.891|1.06|||||Between-subject geometric coefficient of variation was 25.4. Data were analyzed using a power model.|Dose Proportionality Assessment||1.06|0.891|
71114666|NCT01942668|141737386|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.034||0.928|TWO_SIDED|95.0|-0.07|0.06||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.06|-0.07|0.928
71114667|NCT01942668|141737387|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.043||0.231|TWO_SIDED|95.0|-0.14|0.03||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.03|-0.14|0.231
71114668|NCT01942668|141737387|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.042||0.173|TWO_SIDED|95.0|-0.14|0.03||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.03|-0.14|0.173
71114669|NCT01942668|141737387|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.042||0.717|TWO_SIDED|95.0|-0.07|0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.10|-0.07|0.717
71072440|NCT02017717|141653814|SUPERIORITY||Odds Ratio (OR)|0.29|||||TWO_SIDED|95.0|0.15|0.59||||||||0.59|0.15|
71072441|NCT02017717|141653815|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.3791|TWO_SIDED|95.0|0.89|1.36|||log-rank test stratified|||||1.36|0.89|0.3791
71072442|NCT02276053|141653826|OTHER||Retention rate|86.0|||||TWO_SIDED|95.0|79.0|93.1|||||"Confidence intervals for the 6-month retention rate were calculated using Greenwood's formula.~Addition of a note: Not all patients had an Observation Period of 6 months."|The retention rate was derived using Kaplan-Meier methodology where patients who completed the study were censored at the date of last administration of LCM in the study.||93.1|79.0|
71072443|NCT04542499|141653851|SUPERIORITY||LS Mean of Difference|1.103|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|0.553|1.653||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||||1.653|0.553|<0.0001
71072444|NCT04542499|141653852|SUPERIORITY||LS Mean of Difference|-0.943|STANDARD_ERROR_OF_MEAN|0.271||0.0006|TWO_SIDED|95.0|-1.475|-0.41||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||||-0.410|-1.475|0.0006
71072445|NCT04542499|141653853|SUPERIORITY||LS Mean of Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.188||0.2216|TWO_SIDED|95.0|-0.6|0.139||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 2||0.139|-0.600|0.2216
71072446|NCT04542499|141653853|SUPERIORITY||LS Mean of Difference|0.099|STANDARD_ERROR_OF_MEAN|0.211||0.6379|TWO_SIDED|95.0|-0.316|0.515||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 5||0.515|-0.316|0.6379
71072447|NCT04542499|141653853|SUPERIORITY||LS Mean of Difference|0.582|STANDARD_ERROR_OF_MEAN|0.234||0.0132|TWO_SIDED|95.0|0.122|1.042||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 8||1.042|0.122|0.0132
71072448|NCT04542499|141653853|SUPERIORITY||LS Mean of Difference|0.358|STANDARD_ERROR_OF_MEAN|0.236||0.1299|TWO_SIDED|95.0|-0.106|0.821||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 11||0.821|-0.106|0.1299
71072449|NCT04542499|141653853|SUPERIORITY||LS Mean of Difference|0.698|STANDARD_ERROR_OF_MEAN|0.257||0.0068|TWO_SIDED|95.0|0.194|1.202||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 14||1.202|0.194|0.0068
71072450|NCT04542499|141653853|SUPERIORITY||LS Mean of Difference|0.969|STANDARD_ERROR_OF_MEAN|0.254||0.0002|TWO_SIDED|95.0|0.469|1.469||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 18||1.469|0.469|0.0002
71072451|NCT04542499|141653853|SUPERIORITY||LS Mean of Difference|0.879|STANDARD_ERROR_OF_MEAN|0.259||0.0008|TWO_SIDED|95.0|0.369|1.389||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 22||1.389|0.369|0.0008
71072452|NCT04542499|141653853|SUPERIORITY||LS Mean of Difference|1.103|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|0.553|1.653||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||1.653|0.553|<0.0001
71072453|NCT04542499|141653854|SUPERIORITY||LS Mean of Difference|0.108|STANDARD_ERROR_OF_MEAN|0.18||0.5471|TWO_SIDED|95.0|-0.245|0.461||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 2||0.461|-0.245|0.5471
71072454|NCT04542499|141653854|SUPERIORITY||LS Mean of Difference|-0.237|STANDARD_ERROR_OF_MEAN|0.205||0.2488|TWO_SIDED|95.0|-0.64|0.166||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 5||0.166|-0.640|0.2488
71072455|NCT04542499|141653854|SUPERIORITY||LS Mean of Difference|-0.818|STANDARD_ERROR_OF_MEAN|0.221||0.0002|TWO_SIDED|95.0|-1.252|-0.384||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 8||-0.384|-1.252|0.0002
70853285|NCT01743001|141194866|SUPERIORITY||least-square (LS) mean difference|-1.4||||0.634|TWO_SIDED|95.0|-7.2|4.4|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Social Functioning.||4.4|-7.2|0.6340
71072456|NCT04542499|141653854|SUPERIORITY||LS Mean of Difference|-0.753|STANDARD_ERROR_OF_MEAN|0.227||0.001|TWO_SIDED|95.0|-1.199|-0.307||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 11||-0.307|-1.199|0.0010
71072457|NCT04542499|141653854|SUPERIORITY||LS Mean of Difference|-0.904|STANDARD_ERROR_OF_MEAN|0.254||0.0004|TWO_SIDED|95.0|-1.403|-0.405||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 14||-0.405|-1.403|0.0004
70853286|NCT01743001|141194866|SUPERIORITY||least-square (LS) mean difference|-2.8||||0.3384|TWO_SIDED|95.0|-8.7|3.0|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Role-Emotional.||3.0|-8.7|0.3384
70853287|NCT01743001|141194866|SUPERIORITY||least-square (LS) mean difference|-2.3||||0.2704|TWO_SIDED|95.0|-6.4|1.8|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Mental Health Index.||1.8|-6.4|0.2704
70853288|NCT01743001|141194866|SUPERIORITY||least-square (LS) mean difference|-0.4||||0.6431|TWO_SIDED|95.0|-2.1|1.3|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Physical Functioning (norm-based).||1.3|-2.1|0.6431
70853289|NCT01743001|141194866|SUPERIORITY||least-square (LS) mean difference|-0.6||||0.5988|TWO_SIDED|95.0|-2.6|1.5|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Role-Physical (norm-based).||1.5|-2.6|0.5988
70853290|NCT01743001|141194866|SUPERIORITY||least-square (LS) mean difference|0.1||||0.9642|TWO_SIDED|95.0|-2.5|2.6|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Pain Index (norm-based).||2.6|-2.5|0.9642
70853291|NCT01743001|141194866|SUPERIORITY||least-square (LS) mean difference|1.5||||0.1542|TWO_SIDED|95.0|-0.6|3.5|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of General Health Perceptions (norm-based).||3.5|-0.6|0.1542
70853292|NCT01743001|141194866|SUPERIORITY||least-square (LS) mean difference|0.6||||0.602|TWO_SIDED|95.0|-1.5|2.6|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Vitality (norm-based).||2.6|-1.5|0.6020
70853293|NCT01743001|141194866|SUPERIORITY||least-square (LS) mean difference|-0.6||||0.634|TWO_SIDED|95.0|-3.1|1.9|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Social Functioning (norm-based).||1.9|-3.1|0.6340
70853294|NCT01743001|141194866|SUPERIORITY||least-square (LS) mean difference|-1.3||||0.3384|TWO_SIDED|95.0|-4.1|1.4|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Role-Emotional (norm-based).||1.4|-4.1|0.3384
70853295|NCT01743001|141194866|SUPERIORITY||least-square (LS) mean difference|-1.3||||0.2704|TWO_SIDED|95.0|-3.6|1.0|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Mental Health Index.||1.0|-3.6|0.2704
70853296|NCT01743001|141194866|SUPERIORITY||least-square (LS) mean difference|0.7||||0.4332|TWO_SIDED|95.0|-1.0|2.3|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the Physical Component Summary Score.||2.3|-1.0|0.4332
70853297|NCT01743001|141194866|SUPERIORITY||least-square (LS) mean difference|-1.1||||0.3416|TWO_SIDED|95.0|-3.4|1.2|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the Mental Component Summary Score.||1.2|-3.4|0.3416
70853298|NCT01565343|141194867|SUPERIORITY_OR_OTHER||ICC|0.9893||||||95.0|||||ICC|||Intra-class Correlation Coefficient (ICC) of AD subjects 50-70 min test vs. retest values||||
70853299|NCT01565343|141194867|SUPERIORITY_OR_OTHER||ICC|0.9574||||||95.0|||||ICC|||Intra-class Correlation Coefficient of Control subjects 50-70 min test vs. retest values||||
71114670|NCT01942668|141737387|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.042||0.849|TWO_SIDED|95.0|-0.09|0.07||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.07|-0.09|0.849
71114671|NCT01942668|141737388|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.052||0.039|TWO_SIDED|95.0|-0.21|-0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.21|0.039
71114672|NCT01942668|141737388|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.052||0.03|TWO_SIDED|95.0|-0.21|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.21|0.030
70853300|NCT01565343|141194867|SUPERIORITY_OR_OTHER||Mean % difference|2.35|STANDARD_DEVIATION|1.413||||95.0||||||||Intra-subject variability (% difference) of AD subjects 50-70 min test vs. retest values||||
70853301|NCT01565343|141194867|SUPERIORITY_OR_OTHER||Mean % difference|1.49|STANDARD_DEVIATION|0.839||||95.0||||||||Intra-subject variability (% difference) of control subjects 50-70 min test vs. retest values||||
70853302|NCT00600119|141194889|SUPERIORITY_OR_OTHER|||||||0.7781|||||||Wilcoxon (Mann-Whitney)|||||||0.7781
71114673|NCT01942668|141737388|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.052||0.946|TWO_SIDED|95.0|-0.1|0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.10|-0.10|0.946
71114674|NCT01942668|141737388|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.051||0.309|TWO_SIDED|95.0|-0.15|0.05||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.05|-0.15|0.309
71114675|NCT01942668|141737389|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.061||0.031|TWO_SIDED|95.0|-0.25|-0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.25|0.031
70853303|NCT00600119|141194889|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.0020
70853304|NCT00600119|141194889|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||||||0.0001
70853305|NCT00600119|141194890|SUPERIORITY_OR_OTHER|||||||0.5118|||||||Wilcoxon (Mann-Whitney)|||||||0.5118
70853306|NCT00600119|141194890|SUPERIORITY_OR_OTHER|||||||0.0022|||||||Wilcoxon (Mann-Whitney)|||||||0.0022
70853307|NCT00600119|141194890|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
70853308|NCT00600119|141194891|SUPERIORITY_OR_OTHER|||||||0.5522||||||Analysis for change in PAC-QOL Physical Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.5522
70853309|NCT00600119|141194891|SUPERIORITY_OR_OTHER|||||||0.0589||||||Analysis for change in PAC-QOL Physical Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0589
70853310|NCT00600119|141194891|SUPERIORITY_OR_OTHER|||||||0.1691||||||Analysis for change in PAC-QOL Physical Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.1691
70940164|NCT04908800|141380615|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.0|||||TWO_SIDED|95.0|0.905|1.12|||||"Geometric least squares mean was 575 (fasted) and 578 (fed). Within-subject coefficient of variation was 7.05.~Data were analyzed using mixed model which included actual treatment as fixed effect and participant as a random effect."|Food Effect Assessment||1.12|0.905|
70940165|NCT04908800|141380615|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.04|||||TWO_SIDED|95.0|0.707|1.54|||||"Geometric least squares mean was 575 (fasted male) and 600 (fasted female). Between subject coefficient of variation was 31.1.~Data were analyzed using an ANOVA model which included actual treatment as a factor."|Sex Effect Assessment||1.54|0.707|
70940166|NCT04908800|141380616|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|0.989|||||TWO_SIDED|95.0|0.909|1.07|||||Between-subject geometric coefficient of variation was 23.0. Data were analyzed using a power model.|Dose Proportionality Assessment||1.07|0.909|
70940167|NCT04908800|141380616|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|0.948|||||TWO_SIDED|95.0|0.824|1.09|||||"Geometric least squares mean was 31.6 (fasted) and 30.0 (fed). Within-subject coefficient of variation was 9.44.~Data were analyzed using mixed model which included actual treatment as fixed effect and participant as a random effect."|Food Effect Assessment||1.09|0.824|
70940168|NCT04908800|141380616|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.23|||||TWO_SIDED|95.0|0.928|1.62|||||"Geometric least squares mean was 31.6 (fasted male) and 38.8 (fasted female). Between subject coefficient of variation was 22.0.~Data were analyzed using an ANOVA model which included actual treatment as a factor."|Sex Effect Assessment||1.62|0.928|
71072458|NCT04542499|141653854|SUPERIORITY||LS Mean of Difference|-1.024|STANDARD_ERROR_OF_MEAN|0.256|<|0.0001|TWO_SIDED|95.0|-1.528|-0.52||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 18||-0.520|-1.528|<0.0001
70853311|NCT00600119|141194891|SUPERIORITY_OR_OTHER|||||||0.6293||||||Analysis for change in PAC-QOL Worries/Concerns domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.6293
70853312|NCT00600119|141194891|SUPERIORITY_OR_OTHER|||||||0.0836||||||Analysis for change in PAC-QOL Worries/Concerns domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0836
70940169|NCT04908800|141380621|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.11|||||TWO_SIDED|95.0|0.966|1.26|||||Between-subject geometric coefficient of variation was 26.9. Data were analyzed using a power model.|"Dose Proportionality Assessment. KRP-A218 assessed across the following dose levels: 2 mg, 4 mg, 8 mg, and 11 mg.~Dose proportionality results for Part B are only for the Day 14 profile (not Day 1)."||1.26|0.966|
70940170|NCT04908800|141380623|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.12|||||TWO_SIDED|95.0|0.945|1.29|||||Between-subject geometric coefficient of variation was 32.1. Data were analyzed using a power model.|"Dose Proportionality Assessment. KRP-A218 assessed across the following dose levels: 2 mg, 4 mg, 8 mg, and 11 mg.~Dose proportionality results for Part B are only for the Day 14 profile (not Day 1)."||1.29|0.945|
70940171|NCT04908800|141380624|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.1|||||TWO_SIDED|95.0|0.971|1.23|||||Between-subject geometric of coefficient variation was 23.2. Data were analyzed using a power model.|"Dose Proportionality Assessment. KRP-A218 assessed across the following dose levels: 2 mg, 4 mg, 8 mg, and 11 mg.~Dose proportionality results for Part B are only for the Day 14 profile (not Day 1)."||1.23|0.971|
70940172|NCT02267746|141380633|EQUIVALENCE|Estimates of mean percent change from baseline were calculated (separately for inflammatory and non-inflammatory lesions) for the Test and Reference treatment, and then the 90% confidence interval (CI) for the mean ratio was constructed using Fieller's method.|Mean Difference (Net)|0.93|||||TWO_SIDED|90.0|0.86|1.02|||||Therapeutic equivalence was established if the 90% CIs for the ratio of Test/Reference means, for both lesion types, were contained within the interval \[0.80, 1.25\] for the PP population.|||1.02|0.86|
71078699|NCT03244618|141665321|SUPERIORITY||Mean Difference (Final Values)|10.8|||<|0.001|TWO_SIDED|95.0|7.5|14.0|||ANOVA|ANOVA model had treatment and gender as factors.|Difference is first names toothpaste minus second named toothpaste such that a positive difference favours the first named toothpaste.|||14.0|7.5|<0.001
71078700|NCT03244618|141665322|SUPERIORITY||Mean Difference (Final Values)|-11.0|||<|0.001|TWO_SIDED|95.0|-16.4|-5.5|||ANOVA|ANOVA model had treatment and gender as factors.|Difference is first named toothpaste minus second named toothpaste such that a negative difference favours the first named toothpaste.|||-5.5|-16.4|<0.001
71078701|NCT03244618|141665323|SUPERIORITY||Mean Difference (Final Values)|-0.67|||<|0.001|TWO_SIDED|95.0|-0.85|-0.489|||ANOVA|ANOVA model had treatment and gender as factors.|Difference is first named toothpaste minus second named toothpaste such that a negative value favours the first named toothpaste.|||-0.489|-0.850|<0.001
71078702|NCT03244618|141665324|SUPERIORITY||Mean Difference (Final Values)|11.9|||<|0.001|TWO_SIDED|95.0|8.6|15.1|||ANOVA|ANOVA model had treatment and gender as factors.|Difference is first named toothpaste minus second named toothpaste such that a positive difference favours first named toothpaste|||15.1|8.6|<0.001
71078703|NCT03244618|141665325|SUPERIORITY||Mean Difference (Final Values)|-10.9|||<|0.001|TWO_SIDED|95.0|-16.6|-5.2|||ANOVA|ANOVA model had treatment and gender as factors.|Difference is first named toothpaste minus second named toothpaste such that a negative difference favours the first named toothpaste.|||-5.2|-16.6|<0.001
70853313|NCT00600119|141194891|SUPERIORITY_OR_OTHER|||||||0.1155||||||Analysis for change in PAC-QOL Worries/Concerns domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.1155
70853314|NCT00600119|141194891|SUPERIORITY_OR_OTHER|||||||0.9938||||||Analysis for change in PAC-QOL Psychosocial Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.9938
70853315|NCT00600119|141194891|SUPERIORITY_OR_OTHER|||||||0.2101||||||Analysis for change in PAC-QOL Psychosocial Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.2101
71114676|NCT01942668|141737389|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.005|TWO_SIDED|95.0|-0.28|-0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.05|-0.28|0.005
71114677|NCT01942668|141737389|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.06||0.401|TWO_SIDED|95.0|-0.17|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.07|-0.17|0.401
71114678|NCT01942668|141737389|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.059||0.1|TWO_SIDED|95.0|-0.21|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.21|0.100
71114679|NCT01942668|141737390|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.071||0.001|TWO_SIDED|95.0|-0.37|-0.09||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.09|-0.37|0.001
70853316|NCT00600119|141194891|SUPERIORITY_OR_OTHER|||||||0.4597||||||Analysis for change in PAC-QOL Psychosocial Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.4597
70853317|NCT00600119|141194891|SUPERIORITY_OR_OTHER|||||||0.4822||||||Analysis for change in PAC-QOL Satisfaction domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.4822
70853318|NCT00600119|141194891|SUPERIORITY_OR_OTHER|||||||0.0171||||||Analysis for change in PAC-QOL Satisfaction domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0171
70853319|NCT00600119|141194891|SUPERIORITY_OR_OTHER|||||||0.016||||||Analysis for change in PAC-QOL Satisfaction domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0160
71114680|NCT01942668|141737390|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.07||0.034|TWO_SIDED|95.0|-0.28|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.28|0.034
71114681|NCT01942668|141737390|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.79|TWO_SIDED|95.0|-0.16|0.12||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.12|-0.16|0.790
71114682|NCT01942668|141737390|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.069||0.086|TWO_SIDED|95.0|-0.25|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.25|0.086
70853320|NCT00600119|141194891|SUPERIORITY_OR_OTHER|||||||0.6857||||||Analysis for change in PAC-QOL Total Score from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.6857
70853321|NCT00600119|141194891|SUPERIORITY_OR_OTHER|||||||0.0253||||||Analysis for change in PAC-QOL Total Score from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0253
71114683|NCT01942668|141737391|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.084|<|0.001|TWO_SIDED|95.0|-0.53|-0.2||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.20|-0.53|<0.001
71072459|NCT04542499|141653854|SUPERIORITY||LS Mean of Difference|-0.979|STANDARD_ERROR_OF_MEAN|0.261||0.0002|TWO_SIDED|95.0|-1.493|-0.465||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 22||-0.465|-1.493|0.0002
71114684|NCT01942668|141737391|SUPERIORITY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.083||0.03|TWO_SIDED|95.0|-0.34|-0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.02|-0.34|0.030
71114685|NCT01942668|141737391|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.083||0.247|TWO_SIDED|95.0|-0.26|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.07|-0.26|0.247
71114686|NCT01942668|141737391|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.082||0.022|TWO_SIDED|95.0|-0.35|-0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.03|-0.35|0.022
71114687|NCT01942668|141737392|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.085|<|0.001|TWO_SIDED|95.0|-0.54|-0.2||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.20|-0.54|<0.001
70853322|NCT00600119|141194891|SUPERIORITY_OR_OTHER|||||||0.0772||||||Analysis for change in PAC-QOL Total Score from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0772
70853323|NCT00600119|141194892|SUPERIORITY_OR_OTHER|||||||0.5008||||||Analysis for change in PAC-SYM Abdominal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.5008
70853324|NCT00600119|141194892|SUPERIORITY_OR_OTHER|||||||0.1823||||||Analysis for change in PAC-SYM Abdominal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.1823
70853325|NCT00600119|141194892|SUPERIORITY_OR_OTHER|||||||0.7045||||||Analysis for change in PAC-SYM Abdominal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.7045
71072460|NCT04542499|141653854|SUPERIORITY||LS Mean of Difference|-0.943|STANDARD_ERROR_OF_MEAN|0.271||0.0006|TWO_SIDED|95.0|-1.475|-0.41||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.410|-1.475|0.0006
71072461|NCT04542499|141653855|SUPERIORITY||LS Mean of Difference|0.4|STANDARD_ERROR_OF_MEAN|0.4||0.3265|TWO_SIDED|95.0|-0.4|1.2||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Part I||1.2|-0.4|0.3265
71072462|NCT04542499|141653855|SUPERIORITY||LS Mean of Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.52||0.0203|TWO_SIDED|95.0|-2.2|-0.2||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Part II||-0.2|-2.2|0.0203
71072463|NCT04542499|141653855|SUPERIORITY||LS Mean of Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.96||0.0118|TWO_SIDED|95.0|-4.3|-0.5||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Part III||-0.5|-4.3|0.0118
71072464|NCT05711381|141653856|OTHER|PK parameters of HM15912 from the severe renal impairment group (Cohort 2) were to be estimated and compared to the control group (Cohort 1, normal renal function). A one-way analysis of variance (ANOVA) was to be used to compare log transformed PK parameters. The estimates of mean difference and corresponding 90% CIs, as well as each exponentiation of estimates, were to be presented to provide the estimates of GMR.|Geometric mean ratio|0.91|||||TWO_SIDED|90.0|0.59|1.41||||||||1.41|0.59|
71114688|NCT01942668|141737392|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.083||0.002|TWO_SIDED|95.0|-0.42|-0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.09|-0.42|0.002
71114689|NCT01942668|141737392|SUPERIORITY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.084||0.031|TWO_SIDED|95.0|-0.34|-0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.02|-0.34|0.031
71114690|NCT01942668|141737392|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.083||0.016|TWO_SIDED|95.0|-0.36|-0.04||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.04|-0.36|0.016
70853326|NCT00600119|141194892|SUPERIORITY_OR_OTHER|||||||0.7088||||||Analysis for change in PAC-SYM Rectal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.7088
71114691|NCT01942668|141737393|SUPERIORITY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.087|<|0.001|TWO_SIDED|95.0|-0.55|-0.21||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.21|-0.55|<0.001
71114692|NCT01942668|141737393|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.086||0.008|TWO_SIDED|95.0|-0.4|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.06|-0.40|0.008
71114693|NCT01942668|141737393|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.086||0.087|TWO_SIDED|95.0|-0.32|0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.32|0.087
70940173|NCT02267746|141380634|EQUIVALENCE|Estimates of mean percent change from baseline were calculated (separately for inflammatory and non-inflammatory lesions) for the Test and Reference treatment, and then the 90% confidence interval (CI) for the mean ratio was constructed using Fieller's method.|Mean Difference (Net)|0.96|||||TWO_SIDED|90.0|0.89|1.04|||||Therapeutic equivalence was established if the 90% CIs for the ratio of Test/Reference means, for both lesion types, were contained within the interval \[0.80, 1.25\] for the PP population.|||1.04|0.89|
70940174|NCT02267746|141380635|EQUIVALENCE|Therapeutic equivalence was established if the 90% CI for the difference was contained within the interval \[-0.20, +0.20\] for PP population.|Mean Difference (Net)|-0.073|||||TWO_SIDED|90.0|-0.15|0.004|||||Therapeutic equivalence was established if the 90% CI for the difference was contained within the interval \[-0.20, +0.20\] for the PP population.|Success was defined as an IGA score at Week 12 that was at least two grades less than the baseline assessment. Failure was defined as an IGA score that was the same, higher, or one grade lower than the baseline assessment.||0.004|-0.150|
71072465|NCT05711381|141653857|OTHER|PK parameters of HM15912 from the severe renal impairment group (Cohort 2) were to be estimated and compared to the control group (Cohort 1, normal renal function). A one-way analysis of variance (ANOVA) was to be used to compare log transformed PK parameters. The estimates of mean difference and corresponding 90% CIs, as well as each exponentiation of estimates, were to be presented to provide the estimates of GMR.|Geometric mean ratio|1.25|||||TWO_SIDED|90.0|0.93|1.68||||||||1.68|0.93|
71072466|NCT04789291|141653905|OTHER||Ratios of adjusted geometric means [%]|102.76|||||TWO_SIDED|90.0|99.34|106.29|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 4.8.|Relative bioavailability of BI 1595043 administered in fed state (Test) compared with BI 1595043 administered in fasted state (Reference) was estimated by the ratios of the gMeans (Test/Reference). Their corresponding 2-sided 90% CIs were provided. This method corresponds to 2 one-sided t-test procedures, each at the 5% significance level.||106.29|99.34|
71072467|NCT04789291|141653906|OTHER||Ratios of adjusted geometric means [%]|77.81|||||TWO_SIDED|90.0|69.77|86.76|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 15.5.|Relative bioavailability of BI 1595043 administered in fed state (Test) compared with BI 1595043 administered in fasted state (Reference) was estimated by the ratios of the gMeans (Test/Reference). Their corresponding 2-sided 90% CIs were provided. This method corresponds to 2 one-sided t-test procedures, each at the 5% significance level.||86.76|69.77|
71072468|NCT04789291|141653907|OTHER||Ratios of adjusted geometric means [%]|103.24|||||TWO_SIDED|90.0|99.73|106.89|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 4.9.|Relative bioavailability of BI 1595043 administered in fed state (Test) compared with BI 1595043 administered in fasted state (Reference) was estimated by the ratios of the gMeans (Test/Reference). Their corresponding 2-sided 90% CIs were provided. This method corresponds to 2 one-sided t-test procedures, each at the 5% significance level.||106.89|99.73|
71072469|NCT01482962|141653917|SUPERIORITY||Odds Ratio (OR)|0.6||||0.038|TWO_SIDED|95.0|0.33|1.08||P-value was stratified using disease type, International Prognostic Index (IPI) Score and region as stratification factors.|Cochran-Mantel-Haenszel|||||1.08|0.33|0.038
71072470|NCT01482962|141653918|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.177|TWO_SIDED|95.0|0.637|1.178|||Stratified Log Rank||Hazard ratio (HR) was based on a stratified Cox's proportional hazard regression model with stratification factors: disease type, IPI Score and region with treatment as a factor in the model.|||1.178|0.637|0.177
71072471|NCT01482962|141653919|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.338|TWO_SIDED|95.0|0.707|1.369|||Stratified Log-rank Test||Hazard ratio (HR) was based on a stratified Cox's proportional hazard regression model with stratification factors: disease type, IPI Score and region with treatment as a factor in the model.|||1.369|0.707|0.338
71072472|NCT01482962|141653924|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.362|TWO_SIDED|95.0|0.679|1.329|||Stratified Log Rank||Hazard ratio was based on a stratified Cox's proportional hazard regression model with stratification factors: disease type, IPI Score and region with treatment as a factor in the model.|||1.329|0.679|0.362
70853327|NCT00600119|141194892|SUPERIORITY_OR_OTHER|||||||0.5828||||||Analysis for change in PAC-SYM Rectal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.5828
70940175|NCT00348283|141380639|SUPERIORITY_OR_OTHER|||||||0.056||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|Because of the hierarchical testing scheme used for testing the ranked secondary endpoints, alpha level of 0.05 was used at each stage of testing.||ITT population: all subjects randomized at Week 4 who had at least 1 dose of blinded therapy. The sample-size (placebo = 65 subjects; adalimumab = 65 subjects) for the primary efficacy analysis was calculated using 88% power at 0.05 alpha level based on the assumption that 25% and 5% of subjects were without mucosal ulceration at Week 12 in adalimumab 40 mg eow and placebo groups, respectively. However, subjects without mucosal ulceration at Screening were excluded from the primary analysis.||||0.056
71072473|NCT00514904|141654043|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] greater than or equal to (≥) -10%.|Difference in percentage|14.77|||||TWO_SIDED|95.0|10.26|20.23||||||||20.23|10.26|
71072474|NCT00514904|141654043|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥-10%.|Difference in percentage|24.47|||||TWO_SIDED|95.0|17.52|31.87||||||||31.87|17.52|
71072475|NCT00514904|141654043|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥-10%.|Difference in percentage|6.35|||||TWO_SIDED|95.0|2.68|11.08|||Difference in percentage|||||11.08|2.68|
71072476|NCT00514904|141654043|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥-10%.|Difference in percentage|23.92|||||TWO_SIDED|95.0|18.02|30.3||||||||30.3|18.02|
70853328|NCT00600119|141194892|SUPERIORITY_OR_OTHER|||||||0.0116||||||Analysis for change in PAC-SYM Rectal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0116
70853329|NCT00600119|141194892|SUPERIORITY_OR_OTHER|||||||0.7848||||||Analysis for change in PAC-SYM Stool Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.7848
71114694|NCT01942668|141737393|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.085||0.092|TWO_SIDED|95.0|-0.31|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.31|0.092
71114695|NCT01942668|141737394|SUPERIORITY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.092|<|0.001|TWO_SIDED|95.0|-0.66|-0.3||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.30|-0.66|<0.001
71114696|NCT01942668|141737394|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.09||0.001|TWO_SIDED|95.0|-0.47|-0.12||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.12|-0.47|0.001
71114697|NCT01942668|141737394|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.091||0.009|TWO_SIDED|95.0|-0.42|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.06|-0.42|0.009
71114698|NCT01942668|141737394|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.09||0.007|TWO_SIDED|95.0|-0.42|-0.07||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.07|-0.42|0.007
71114699|NCT01942668|141737395|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.096|<|0.001|TWO_SIDED|95.0|-0.71|-0.33||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.33|-0.71|<0.001
71114700|NCT01942668|141737395|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.094||0.003|TWO_SIDED|95.0|-0.46|-0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.09|-0.46|0.003
71072477|NCT00514904|141654044|NON_INFERIORITY|Criterion for assessment: upper limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the ratio between Nimenrix Group and Mencevax ACWY Group being lower than or equal to the pre-defined clinical limit ratio of 3.0 in the percentage of subjects with any grade 3 general symptoms.|Risk Ratio (RR)|3.34||||0.2202|TWO_SIDED|95.0|0.56|20.25|||Chi-squared|||||20.25|0.56|0.2202
71072478|NCT00084318|141654059|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.05|TWO_SIDED|95.0|0.54|1.06|||Log Rank|Historical control data (RTOG-9501/NCT00002670): n=202, two-year disease-free survival rate of 54.8% (47.9% to 61.7%).||Using the method of Dixon and Simon, 104 analyzable patients per arm were needed to detect a ≥ 33 reduction in the hazard rate for disease-free survival compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) with 80% power and one-sided log-rank test at the 0.05 level. Two-year rates were estimated by the Kaplan-Meier method. \[RTOG = Radiation Therapy Oncology Group\]||1.06|0.54|0.05
71072479|NCT00084318|141654059|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.01|TWO_SIDED|95.0|0.5|0.96|||Log Rank|Historical control data (RTOG-9501/NCT00002670): n=202, two-year disease-free survival rate of 54.8% (47.9% to 61.7%).||Using the method of Dixon and Simon, 104 analyzable patients per arm were needed to detect a ≥ 33 reduction in the hazard rate for disease-free survival compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) with 80% power and one-sided log-rank test at the 0.05 level. Two-year rates were estimated by the Kaplan-Meier method.||0.96|0.50|0.01
71072480|NCT00084318|141654060|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.04|TWO_SIDED|95.0|0.5|1.03|||Log Rank|Historical control data (RTOG-9501/NCT00002670): n=202, two-year survival rate of 64.7% (58.1% to 71.3%).|Reference arm = historical control|Two-year rates were estimated by the Kaplan-Meier method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided log-rank test. Hazard ratios were estimated by Cox model. \[RTOG = Radiation Therapy Oncology Group\]||1.03|0.5|0.04
71072481|NCT00084318|141654060|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.56||||0.001|TWO_SIDED|95.0|0.39|0.82|||Log Rank|Historical control data (RTOG-9501/NCT00002670): n=202, two-year survival rate of 64.7% (58.1% to 71.3%).|Reference arm = historical control|Two-year rates were estimated by the Kaplan-Meier method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided log-rank test. Hazard ratios were estimated by Cox model.||0.82|0.39|0.001
71072482|NCT00084318|141654064|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.66|TWO_SIDED|95.0|0.63|1.76|||Gray's test|Historical control data (RTOG-9501/NCT00002670): n=202, two-year failure rate of 19.9% (12.2% to 27.5%)|Reference arm = historical control|Two-year failure rates were estimated by the cumulative incidence method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided Gray's test. Hazard ratios were estimated by Cox model. \[RTOG = Radiation Therapy Oncology Group\]||1.76|0.63|0.66
71114701|NCT01942668|141737395|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.095||0.016|TWO_SIDED|95.0|-0.41|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.04|-0.41|0.016
71114702|NCT01942668|141737395|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.094||0.31|TWO_SIDED|95.0|-0.28|0.09||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.09|-0.28|0.310
71114703|NCT01942668|141737396|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.098|<|0.001|TWO_SIDED|95.0|-0.72|-0.34||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.34|-0.72|<0.001
71114704|NCT01942668|141737396|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.096|<|0.001|TWO_SIDED|95.0|-0.56|-0.19||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.19|-0.56|<0.001
71114705|NCT01942668|141737396|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.097||0.011|TWO_SIDED|95.0|-0.44|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.06|-0.44|0.011
71114706|NCT01942668|141737396|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.096||0.076|TWO_SIDED|95.0|-0.36|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.36|0.076
71114707|NCT01942668|141737397|SUPERIORITY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.77|-0.38||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.38|-0.77|<0.001
71114708|NCT01942668|141737397|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.59|-0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.20|-0.59|<0.001
71114709|NCT01942668|141737397|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.1||0.018|TWO_SIDED|95.0|-0.43|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.04|-0.43|0.018
71114710|NCT01942668|141737397|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.098||0.096|TWO_SIDED|95.0|-0.36|0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.03|-0.36|0.096
70853330|NCT00600119|141194892|SUPERIORITY_OR_OTHER|||||||0.0335||||||Analysis for change in PAC-SYM Stool Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0335
70853331|NCT00600119|141194892|SUPERIORITY_OR_OTHER|||||||0.0591||||||Analysis for change in PAC-SYM Stool Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0591
70940176|NCT00348283|141380640|SUPERIORITY_OR_OTHER|||||||0.021||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|||The null hypothesis was that there is no difference in proportion of subjects with clinical remission at Week 12 in the two treatment groups.||||0.021
70940177|NCT00348283|141380641|SUPERIORITY_OR_OTHER||||||<|0.001||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|||The null hypothesis was that there is no difference between proportions of subjects without mucosal ulceration at Week 52 in the two treatment groups.||||<0.001
71072483|NCT00084318|141654064|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.86|TWO_SIDED|95.0|0.72|1.87|||Gray's test|Historical control data (RTOG-9501/NCT00002670): n=202, two-year failure rate of 19.9% (12.2% to 27.5%)|Reference arm = historical control|Two-year failure rates were estimated by the cumulative incidence method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided Gray's test. Hazard ratios were estimated by Cox model.||1.87|0.72|0.86
71072484|NCT03301740|141654124|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.2||||0.5|TWO_SIDED|95.0|0.8|1.7||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in intradialytic hypotension between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||1.7|0.8|0.5
71072485|NCT03301740|141654125|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Beta coefficient|-2.8||||0.2|TWO_SIDED|95.0|-6.9|1.4||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in troponin T change between UF profiling and conventional HD. Repeated measure linear regression was performed, giving each subject a random intercept term. The coefficient is the difference in the outcome between UF profiling and conventional HD.||1.4|-6.9|0.2
71072486|NCT03301740|141654126|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.5||||0.1|TWO_SIDED|95.0|0.2|1.3||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in troponin T rise between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||1.3|0.2|0.1
71072487|NCT03301740|141654127|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Mean Difference (Final Values)|-0.8||||0.2|TWO_SIDED|95.0|-2.0|0.5||Statistically significant p-value is \<0.05|Wilcoxon (Mann-Whitney)|||Null hypothesis = no difference in left ventricular GLS change between UF profiling and conventional HD. Wilcoxon (Mann-Whitney) tests were performed assessing the difference of the endpoint between the 2 treatment groups.||0.5|-2.0|0.2
71072488|NCT03301740|141654128|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Beta coefficient|-0.2||||0.9|TWO_SIDED|95.0|-2.0|1.7||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in nadir systolic BP between UF profiling and conventional HD. Repeated measure linear regression was performed, giving each subject a random intercept term. The coefficient is the difference in the outcome between UF profiling and conventional HD.||1.7|-2.0|0.9
71072489|NCT03301740|141654129|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.0||||0.8|TWO_SIDED|95.0|0.7|1.3||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in failed target weight achievement between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||1.3|0.7|0.8
71072490|NCT03301740|141654130|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.0||||0.9|TWO_SIDED|95.0|0.4|2.1||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important cramping between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||2.1|0.4|0.9
71114711|NCT01942668|141737398|SUPERIORITY||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|2.88||0.865|TWO_SIDED|95.0|-5.16|6.14||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||6.14|-5.16|0.865
70853332|NCT00600119|141194892|SUPERIORITY_OR_OTHER|||||||0.9317||||||Analysis for change in PAC-SYM Total Score from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.9317
70853333|NCT00600119|141194892|SUPERIORITY_OR_OTHER|||||||0.0675||||||Analysis for change in PAC-SYM Total Score from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0675
71072491|NCT03301740|141654131|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.7||||0.5|TWO_SIDED|95.0|0.2|2.2||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important nausea/upset stomach between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||2.2|0.2|0.5
71072492|NCT03301740|141654132|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.1|16.0|||Mixed Models Analysis|||Null hypothesis = no difference in clinically important Vomiting/throwing up score between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||16.0|0.1|1.0
71072493|NCT03301740|141654133|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.2||||0.04|TWO_SIDED|95.0|0.1|0.9||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important dizziness/lightheadedness between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||0.9|0.1|0.04
71072494|NCT03301740|141654134|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|3.1||||0.3|TWO_SIDED|95.0|0.3|32.4||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important racing heart/heart palpitations between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||32.4|0.3|0.3
71114712|NCT01942668|141737398|SUPERIORITY||Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|2.83||0.847|TWO_SIDED|95.0|-5.01|6.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||6.10|-5.01|0.847
71114713|NCT01942668|141737398|SUPERIORITY||Mean Difference (Final Values)|2.09|STANDARD_ERROR_OF_MEAN|2.85||0.463|TWO_SIDED|95.0|-3.5|7.68||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||7.68|-3.50|0.463
71114714|NCT01942668|141737398|SUPERIORITY||Mean Difference (Final Values)|-3.55|STANDARD_ERROR_OF_MEAN|2.81||0.207|TWO_SIDED|95.0|-9.07|1.97||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||1.97|-9.07|0.207
71114715|NCT01942668|141737399|SUPERIORITY||Mean Difference (Final Values)|-5.07|STANDARD_ERROR_OF_MEAN|3.43||0.14|TWO_SIDED|95.0|-11.8|1.67||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||1.67|-11.80|0.140
71114716|NCT01942668|141737399|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|3.38||0.982|TWO_SIDED|95.0|-6.7|6.55||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||6.55|-6.70|0.982
71114717|NCT01942668|141737399|SUPERIORITY||Mean Difference (Final Values)|2.33|STANDARD_ERROR_OF_MEAN|3.39||0.492|TWO_SIDED|95.0|-4.32|8.98||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||8.98|-4.32|0.492
71114718|NCT01942668|141737399|SUPERIORITY||Mean Difference (Final Values)|-4.14|STANDARD_ERROR_OF_MEAN|3.35||0.216|TWO_SIDED|95.0|-10.72|2.43||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||2.43|-10.72|0.216
71114719|NCT01942668|141737400|SUPERIORITY||Mean Difference (Final Values)|-10.38|STANDARD_ERROR_OF_MEAN|3.5||0.003|TWO_SIDED|95.0|-17.26|-3.5||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-3.50|-17.26|0.003
71114720|NCT01942668|141737400|SUPERIORITY||Mean Difference (Final Values)|-3.75|STANDARD_ERROR_OF_MEAN|3.45||0.277|TWO_SIDED|95.0|-10.53|3.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||3.02|-10.53|0.277
71114721|NCT01942668|141737400|SUPERIORITY||Mean Difference (Final Values)|-2.95|STANDARD_ERROR_OF_MEAN|3.46||0.394|TWO_SIDED|95.0|-9.75|3.84||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||3.84|-9.75|0.394
71114722|NCT01942668|141737400|SUPERIORITY||Mean Difference (Final Values)|-7.86|STANDARD_ERROR_OF_MEAN|3.42||0.022|TWO_SIDED|95.0|-14.58|-1.15||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-1.15|-14.58|0.022
71114723|NCT01942668|141737401|SUPERIORITY||Mean Difference (Final Values)|-15.32|STANDARD_ERROR_OF_MEAN|3.78|<|0.001|TWO_SIDED|95.0|-22.75|-7.89||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-7.89|-22.75|<0.001
71114724|NCT01942668|141737401|SUPERIORITY||Mean Difference (Final Values)|-8.92|STANDARD_ERROR_OF_MEAN|3.73||0.017|TWO_SIDED|95.0|-16.24|-1.6||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-1.60|-16.24|0.017
70853334|NCT00600119|141194892|SUPERIORITY_OR_OTHER|||||||0.1745||||||Analysis for change in PAC-SYM Total Score from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.1745
70853335|NCT01270802|141194919|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.81|STANDARD_ERROR_OF_MEAN|0.76||0.67|TWO_SIDED|95.0|-0.75|2.37||P-value was not adjusted for multiple comparisons; P\<0.05 was considered statistically significant.|t-test, 2 sided|||We assumed that the declines in FMD seen with TDF/FTC/EFV in our previous study would fully reverse. Thus, the clinically relevant effect size to be detected for FMD change was +3.12% (SD 4%) in those switching from EFV to RAL. Using a two-sample, independent, two-tailed t-test with 5% type I error and 20% type II error, a sample size of 13 per group would be needed to find a difference in FMD between groups. Allowing for a 10% dropout rate, we planned to recruit 15 subjects per group.||2.37|-0.75|0.67
71072495|NCT03301740|141654135|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.2|6.0||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important chest pain between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||6.0|0.2|1.0
71114725|NCT01942668|141737401|SUPERIORITY||Mean Difference (Final Values)|-4.56|STANDARD_ERROR_OF_MEAN|3.74||0.223|TWO_SIDED|95.0|-11.9|2.78||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||2.78|-11.90|0.223
70853336|NCT01270802|141194920|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.63|STANDARD_ERROR_OF_MEAN|5.52||0.4|TWO_SIDED|95.0|-13.04|9.77||P-value was not adjusted for multiple comparisons. P\<0.05 was considered statistically significant.|t-test, 2 sided|||||9.77|-13.04|0.40
71114726|NCT01942668|141737401|SUPERIORITY||Mean Difference (Final Values)|-11.32|STANDARD_ERROR_OF_MEAN|3.69||0.002|TWO_SIDED|95.0|-18.57|-4.07||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.07|-18.57|0.002
71114727|NCT01942668|141737402|SUPERIORITY||Mean Difference (Final Values)|-17.47|STANDARD_ERROR_OF_MEAN|3.66|<|0.001|TWO_SIDED|95.0|-24.65|-10.28||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-10.28|-24.65|<0.001
71114728|NCT01942668|141737402|SUPERIORITY||Mean Difference (Final Values)|-10.26|STANDARD_ERROR_OF_MEAN|3.6||0.005|TWO_SIDED|95.0|-17.33|-3.18||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-3.18|-17.33|0.005
70940178|NCT00348283|141380642|SUPERIORITY_OR_OTHER|||||||0.001||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|||The null hypothesis was that there is no difference in proportion of subjects with clinical remission at Week 52 in the two treatment groups.||||0.001
70940179|NCT00348283|141380643|SUPERIORITY_OR_OTHER|||||||0.15||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|||The null hypothesis was that there is no difference between proportions of subjects without mucosal ulceration at both Week 12 and Week 52 in the two treatment groups.||||0.150
70940180|NCT00348283|141380644|SUPERIORITY_OR_OTHER||||||<|0.001||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|||The null hypothesis was that there is no difference in proportion of subjects with clinical remission at Week 12 in the two treatment groups.||||<0.001
70940181|NCT00763919|141380676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Sign test|||The null hypothesis is that the median difference between 6 months and baseline equals zero.||||<.001
70940182|NCT00763919|141380677|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Sign test|||The null hypothesis is that the median difference between 6 months and baseline equals zero.||||.01
71072496|NCT03301740|141654136|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.3||||0.7|TWO_SIDED|95.0|0.3|6.5||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important shortness of breath between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||6.5|0.3|0.7
71072497|NCT03301740|141654137|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.6||||0.2|TWO_SIDED|95.0|0.3|1.2||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important thirst/dry mouth between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||1.2|0.3|0.2
71114729|NCT01942668|141737402|SUPERIORITY||Mean Difference (Final Values)|-6.21|STANDARD_ERROR_OF_MEAN|3.62||0.087|TWO_SIDED|95.0|-13.31|0.89||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.89|-13.31|0.087
70853337|NCT04620798|141194925|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.96|1.07|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.07|0.96|
70940183|NCT00763919|141380678|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Sign test|||The null hypothesis is that the median difference between 6 months and baseline equals zero.||||<.001
70940184|NCT00763919|141380679|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||<.001
70940185|NCT00763919|141380680|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||<.001
71072498|NCT03301740|141654138|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.9||||0.8|TWO_SIDED|95.0|0.4|2.3||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important headache between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||2.3|0.4|0.8
71114730|NCT01942668|141737402|SUPERIORITY||Mean Difference (Final Values)|-12.66|STANDARD_ERROR_OF_MEAN|3.57|<|0.001|TWO_SIDED|95.0|-19.68|-5.65||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.65|-19.68|<0.001
70940186|NCT00763919|141380681|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.||||.042
70940187|NCT00763919|141380682|SUPERIORITY_OR_OTHER|||||||0.044||95.0|||||Sign test|||The null hypothesis is that the median difference between 6 months and baseline equals zero.||||.044
70940188|NCT00763919|141380683|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.||||.002
70940189|NCT00763919|141380684|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Sign test|||The null hypothesis is that the median difference between 6 months and baseline equals zero.||||.001
70940190|NCT00763919|141380685|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.||||.001
70940191|NCT00763919|141380686|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.||||.001
70940192|NCT00763919|141380687|SUPERIORITY_OR_OTHER|||||||0.827||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.||||.827
70940193|NCT00763919|141380688|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.||||.002
70940194|NCT00763919|141380689|SUPERIORITY_OR_OTHER|||||||0.246||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||.246
70940195|NCT00763919|141380690|SUPERIORITY_OR_OTHER|||||||0.101||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||.101
70940196|NCT00763919|141380691|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||.003
70940197|NCT00763919|141380692|SUPERIORITY_OR_OTHER|||||||0.096||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||.096
70940198|NCT00763919|141380693|SUPERIORITY_OR_OTHER|||||||0.072||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||.072
71072499|NCT03301740|141654139|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|2.8||||0.02|TWO_SIDED|95.0|1.2|6.6||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important itching between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||6.6|1.2|0.02
71072500|NCT03301740|141654140|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.2||||0.7|TWO_SIDED|95.0|0.5|2.6||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important restless legs/difficulty keeping legs still between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||2.6|0.5|0.7
71072501|NCT03301740|141654141|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.6||||0.5|TWO_SIDED|95.0|0.2|2.4||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important tingling/feeling of pins and needles between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||2.4|0.2|0.5
71072502|NCT01047332|141654158|OTHER|||||||0.53|||||||Log Rank|||||||0.530
71072503|NCT01047332|141654159|OTHER|||||||0.997|||||||Log Rank|||||||0.997
71072504|NCT03521817|141654164|OTHER||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|0.14|<|0.231|TWO_SIDED||||||t-test, 2 sided|||||||<0.231
71072505|NCT01390428|141654177|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio (GMR)|1.21|||||TWO_SIDED|90.0|0.73|2.01|||||Mild Hepatic Impairment (HI)/Healthy Matched to Mild HI|Day 1||2.01|0.73|
71072506|NCT01390428|141654177|SUPERIORITY_OR_OTHER||GMR|1.66|||||TWO_SIDED|90.0|1.05|2.61|||||Mild HI/Healthy Matched to Mild HI|Day 10||2.61|1.05|
71072507|NCT01390428|141654177|SUPERIORITY_OR_OTHER||GMR|5.03|||||TWO_SIDED|90.0|2.19|11.56|||||Moderate HI/Healthy Matched to Moderate HI|Day 1||11.56|2.19|
71072508|NCT01390428|141654177|SUPERIORITY_OR_OTHER||GMR|4.82|||||TWO_SIDED|90.0|2.6|8.93|||||Moderate HI/Healthy Matched to Moderate HI|Day 10||8.93|2.60|
71072509|NCT01390428|141654177|SUPERIORITY_OR_OTHER||GMR|19.83|||||TWO_SIDED|90.0|8.11|48.51|||||Severe HI/Healthy Matched to Severe HI|Day 1||48.51|8.11|
71114731|NCT01942668|141737403|SUPERIORITY||Mean Difference (Final Values)|-20.32|STANDARD_ERROR_OF_MEAN|3.8|<|0.001|TWO_SIDED|95.0|-27.77|-12.87||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-12.87|-27.77|<0.001
71114732|NCT01942668|141737403|SUPERIORITY||Mean Difference (Final Values)|-12.61|STANDARD_ERROR_OF_MEAN|3.73|<|0.001|TWO_SIDED|95.0|-19.95|-5.28||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.28|-19.95|<0.001
71114733|NCT01942668|141737403|SUPERIORITY||Mean Difference (Final Values)|-8.33|STANDARD_ERROR_OF_MEAN|3.75||0.027|TWO_SIDED|95.0|-15.7|-0.96||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.96|-15.70|0.027
70940199|NCT00763919|141380694|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 1 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||<.001
70940200|NCT00763919|141380695|SUPERIORITY_OR_OTHER|||||||0.078||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||.078
70940201|NCT00763919|141380696|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||.002
71072510|NCT01390428|141654177|SUPERIORITY_OR_OTHER||GMR|11.68|||||TWO_SIDED|90.0|6.1|22.35|||||Severe HI/Healthy Matched to Severe HI|Day 10||22.35|6.10|
71072511|NCT01390428|141654178|SUPERIORITY_OR_OTHER||GMR|0.84|||||TWO_SIDED|90.0|0.35|2.01|||||Mild HI/Healthy Matched to Mild HI|Day 1||2.01|0.35|
71072512|NCT01390428|141654178|SUPERIORITY_OR_OTHER||GMR|1.37|||||TWO_SIDED|90.0|0.83|2.27|||||Mild HI/Healthy Matched to Mild HI|Day 10||2.27|0.83|
71072513|NCT01390428|141654178|SUPERIORITY_OR_OTHER||GMR|7.64|||||TWO_SIDED|90.0|2.74|21.27|||||Moderate HI/Healthy Matched to Moderate HI|Day 1||21.27|2.74|
71072514|NCT01390428|141654178|SUPERIORITY_OR_OTHER||GMR|5.98|||||TWO_SIDED|90.0|2.84|12.57|||||Moderate HI/Healthy Matched to Moderate HI|Day 10||12.57|2.84|
71072515|NCT01390428|141654178|SUPERIORITY_OR_OTHER||GMR|15.18|||||TWO_SIDED|90.0|6.02|38.25|||||Severe HI/Healthy Matched to Severe HI|Day 1||38.25|6.02|
71072516|NCT01390428|141654178|SUPERIORITY_OR_OTHER||GMR|13.01|||||TWO_SIDED|90.0|6.0|28.21|||||Severe HI/Healthy Matched to Severe HI|Day 10||28.21|6.00|
71114734|NCT01942668|141737403|SUPERIORITY||Mean Difference (Final Values)|-13.85|STANDARD_ERROR_OF_MEAN|3.71|<|0.001|TWO_SIDED|95.0|-21.13|-6.58||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.58|-21.13|<0.001
71114735|NCT01942668|141737404|SUPERIORITY||Mean Difference (Final Values)|-21.45|STANDARD_ERROR_OF_MEAN|3.78|<|0.001|TWO_SIDED|95.0|-28.87|-14.04||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-14.04|-28.87|<0.001
70940202|NCT00763919|141380697|SUPERIORITY_OR_OTHER|||||||0.562||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||.562
71114736|NCT01942668|141737404|SUPERIORITY||Mean Difference (Final Values)|-16.1|STANDARD_ERROR_OF_MEAN|3.71|<|0.001|TWO_SIDED|95.0|-23.39|-8.8||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-8.80|-23.39|<0.001
71114737|NCT01942668|141737404|SUPERIORITY||Mean Difference (Final Values)|-12.01|STANDARD_ERROR_OF_MEAN|3.73||0.001|TWO_SIDED|95.0|-19.34|-4.68||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.68|-19.34|0.001
71114738|NCT01942668|141737404|SUPERIORITY||Mean Difference (Final Values)|-15.73|STANDARD_ERROR_OF_MEAN|3.69|<|0.001|TWO_SIDED|95.0|-22.97|-8.49||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-8.49|-22.97|<0.001
71114739|NCT01942668|141737405|SUPERIORITY||Mean Difference (Final Values)|-20.52|STANDARD_ERROR_OF_MEAN|3.84|<|0.001|TWO_SIDED|95.0|-28.06|-12.97||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-12.97|-28.06|<0.001
70940203|NCT00763919|141380698|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||.12
70940204|NCT03305458|141380705|SUPERIORITY||||||||||||||||||To determine if child and caregiver engagement is affected by overall SPARK use, a 2-level MLM (level-1 child, level-2 provider) will be used. Engagement scores will be calculated per child and caregiver participant. An aggregate engagement score will determine if there are differences across conditions (SPARK + TF CBT vs standard TF-CBT) while accounting for the nesting providers.|||
71072517|NCT01390428|141654180|SUPERIORITY_OR_OTHER||GMR|1.86|||||TWO_SIDED|90.0|1.54|2.24|||||Mild HI/Healthy Matched to Mild HI|||2.24|1.54|
71072518|NCT01390428|141654180|SUPERIORITY_OR_OTHER||GMR|2.99|||||TWO_SIDED|90.0|1.31|6.82|||||Moderate HI/Healthy Matched to Moderate HI|||6.82|1.31|
71072519|NCT01390428|141654182|SUPERIORITY_OR_OTHER||GMR|1.92|||||TWO_SIDED|90.0|1.4|2.63|||||Mild HI/Healthy Matched to Mild HI|||2.63|1.40|
71072520|NCT01390428|141654182|SUPERIORITY_OR_OTHER||GMR|3.59|||||TWO_SIDED|90.0|1.81|7.11|||||Moderate HI/Healthy Matched to Moderate HI|||7.11|1.81|
71072521|NCT01390428|141654182|SUPERIORITY_OR_OTHER||GMR|9.34|||||TWO_SIDED|90.0|4.98|17.51|||||Severe HI/Healthy Matched to Severe HI|||17.51|4.98|
71114740|NCT01942668|141737405|SUPERIORITY||Mean Difference (Final Values)|-15.37|STANDARD_ERROR_OF_MEAN|3.78|<|0.001|TWO_SIDED|95.0|-22.8|-7.95||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-7.95|-22.80|<0.001
71072522|NCT04281784|141654202|SUPERIORITY||Risk Difference (RD)|0.0421||||0.027|TWO_SIDED|95.0|0.0047|0.0777||two-sided test, no adjustment for multiple comparisons|Regression, Linear|Occurrence of discussion regressed on randomization condition, adjusted for ADRD status, hospital, and time between study start \& randomization date.|Robust standard error|Usual care = reference group; intervention arm = comparison group||0.0777|0.0047|0.027
71072523|NCT04281784|141654204|SUPERIORITY||Mean Difference (Final Values)|-0.078|STANDARD_ERROR_OF_MEAN|0.246||0.75|TWO_SIDED|95.0|-0.56|0.404|||Regression, Linear|Outcome (days alive and out of ICU) regressed on Arm/Group (0=usual care, 1=intervention), adjusted for hospital and ADRD status|Robust (HC3) standard error|Superior outcome for Group 2||0.404|-0.560|0.750
71072524|NCT04281784|141654205|SUPERIORITY||Median Difference (Final Values)|-0.361|STANDARD_ERROR_OF_MEAN|0.357||0.312|TWO_SIDED|95.0|-1.06|0.338|||Regression, Linear|Outcome (days alive and out of hospital) regressed on Arm/Group (0=usual care, 1=intervention), adjusted for hospital and ADRD status|Robust (HC3) standard error|Superior outcome for Group 2||0.338|-1.060|0.312
71114741|NCT01942668|141737405|SUPERIORITY||Mean Difference (Final Values)|-11.49|STANDARD_ERROR_OF_MEAN|3.8||0.003|TWO_SIDED|95.0|-18.95|-4.03||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.03|-18.95|0.003
71114742|NCT01942668|141737405|SUPERIORITY||Mean Difference (Final Values)|-13.82|STANDARD_ERROR_OF_MEAN|3.75|<|0.001|TWO_SIDED|95.0|-21.19|-6.46||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.46|-21.19|<0.001
71114743|NCT01942668|141737406|SUPERIORITY||Mean Difference (Final Values)|-20.34|STANDARD_ERROR_OF_MEAN|3.87|<|0.001|TWO_SIDED|95.0|-27.93|-12.74||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-12.74|-27.93|<0.001
70940205|NCT03305458|141380706|SUPERIORITY||||||||||||||||||To determine if provider fidelity is affected by overall SPARK use, a 2-level MLM (level-1 child; level-2 provider) will be used. Fidelity will be measured by the TF-CBT TPOCS-S. Providers' overall use of the toolkit will be calculated per child participant and averaged across toolkit content. Fidelity scores will be calculated per child participant such that each provider will have three ratings. An aggregate fidelity score will determine if there are differences across conditions (SPARK + TF-CBT vs. standard TF-CBT) while accounting for the nesting of providers.|||
70940206|NCT03305458|141380707|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-to provider.|||
71072525|NCT04281784|141654206|SUPERIORITY||Risk Difference (RD)|0.012||||0.475|TWO_SIDED|95.0|-0.02|0.043||two-sided test, no adjustment for multiple comparisons|Regression, Linear|Readmission (0, 1) regressed on randomization condition (0=usual care, 1=intervention), adjusted for ADRD status, and hospital site.|Robust standard error|Usual care = reference group; intervention arm = comparison group||0.043|-0.020|0.475
71072526|NCT04281784|141654207|SUPERIORITY||Risk Difference (RD)|-0.009||||0.61|TWO_SIDED|95.0|-0.043|0.025||two-sided test, no adjustment for multiple comparisons|Regression, Linear|ICU care (0,1) regressed on randomization condition (0=usual care, 1=intervention), adjusted for ADRD status, and hospital site.|Robust standard error|Usual care = reference group; intervention arm = comparison group||0.025|-0.043|0.610
71072527|NCT04281784|141654208|SUPERIORITY|Higher cost indicates worse outcome. Missing if cost data unavailable from Finance Office.|Slope|0.022|STANDARD_ERROR_OF_MEAN|0.058||0.71|TWO_SIDED|95.0|-0.092|0.135|||other type of regression|Generalized linear model (gamma family, log link); Outcome on study arm (0=control, 1=intervention) adjusted for hospital and ADRD status, robust SEs.|Robust standard error|Superior outcome for Group 2||0.135|-0.092|0.710
71072528|NCT04281784|141654209|SUPERIORITY||Risk Difference (RD)|0.487|STANDARD_ERROR_OF_MEAN|0.899||0.588|TWO_SIDED|95.0|-1.275|2.249||two-sided test, no adjustment for multiple comparisons|Regression, Linear|Died within 30 days after randomization regressed on randomization condition (0=usual care, 1=intervention) adjusted for hospital and ADRD status|Robust standard error|Usual care=reference group; intervention arm = comparison group||2.249|-1.275|0.588
71072529|NCT04281784|141654210|SUPERIORITY|Higher cost indicates worse outcome. Missing if cost data unavailable from Finance Office.|Slope|-0.028|STANDARD_ERROR_OF_MEAN|0.069||0.685|TWO_SIDED|95.0|-0.162|0.107|||other type of regression|Generalized linear model (gamma family, log link); Outcome on study arm (0=control, 1=intervention) adjusted for hospital and ADRD status, robust SEs.|Robust standard error|Superior outcome for Group 2||0.107|-0.162|0.685
71072530|NCT04322539|141654211|SUPERIORITY||Stratified Hazard Ratio|0.662|||<|0.001|TWO_SIDED|95.0|0.549|0.8||Raw unadjusted p-value was obtained by using a stratified log-rank test accounting for the randomization schedule stratification factors.|stratified log-rank test||The HR between 2 treatment groups (fruquintinib vs placebo), together with its 95 percent (%) confidence interval (CI), was calculated from a stratified Cox proportional hazards model accounting for the randomization schedule stratification factors.|||0.800|0.549|< .001
71072531|NCT04322539|141654212|SUPERIORITY||Hazard Ratio (HR)|0.321|||<|0.001|TWO_SIDED|95.0|0.267|0.386||Raw unadjusted p-value was obtained by using a stratified log-rank test accounting for the randomization schedule stratification factors.|stratified log-rank test||The HR between the 2 treatment groups (fruquintinib vs placebo), together with its 95% CI, was calculated from a stratified Cox proportional hazards model accounting for the randomization schedule stratification factors.|||0.386|0.267|< .001
70940207|NCT03305458|141380708|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
71072532|NCT04322539|141654213|SUPERIORITY||Adjusted difference|1.5||||0.059|TWO_SIDED|95.0|0.4|2.7||p-value was calculated from a stratified Cochran-Mantel Haenszel test accounting for the randomization schedule stratification factors.|Cochran-Mantel-Haenszel||The adjusted difference and its 95% CI were calculated using the Wald method from Cochran-Mantel Haenszel test to account for the randomization schedule stratification factors.|||2.7|0.4|.059
71072533|NCT04322539|141654214|SUPERIORITY||Adjusted difference|39.4|||<|0.001|TWO_SIDED|95.0|32.8|46.0||p-value was calculated from a stratified Cochran-Mantel Haenszel test accounting for the randomization schedule stratification factors.|Cochran-Mantel-Haenszel||The adjusted difference and its 95% CI were calculated using the Wald method from Cochran-Mantel Haenszel test to account for the randomization schedule stratification factors.|||46.0|32.8|<.001
71072534|NCT04322539|141654220|OTHER|||||||0.06|||||||Wald test|||CminSS Based on the Starting Dose for OS Exposure-Response Analyses||||0.0600
71072535|NCT04322539|141654220|OTHER|||||||0.8065|||||||Wald test|||CminSS Based on the Adjusted RDI for OS Exposure-Response Analyses||||0.8065
71072536|NCT04322539|141654221|OTHER|||||||0.265|||||||Wald test|||CmaxSS for Gr Dermatological toxicity for Exposure-Response Analyses.||||0.265
71072537|NCT04322539|141654221|OTHER|||||||0.0159|||||||Wald test|||CmaxSS for Gr3+ Dermatological Toxicity for Exposure-Response Analyses.||||0.0159
71072538|NCT04322539|141654221|OTHER|||||||0.484|||||||Wald test|||CmaxSS for Gr Proteinuria for Exposure-Response Analyses.||||0.484
70940208|NCT03305458|141380709|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
71072539|NCT04322539|141654221|OTHER|||||||0.642|||||||Wald test|||CmaxSS for Gr3+ Proteinuria for Exposure-Response Analyses.||||0.642
71072540|NCT04322539|141654221|OTHER|||||||0.166|||||||Wald test|||CmaxSS for Gr Hemorrhage for Exposure-Response Analyses.||||0.166
71072541|NCT01702532|141654227|SUPERIORITY_OR_OTHER||LS Means Difference|-4.9||||0.0141|TWO_SIDED|95.0|-8.8|-0.99||The comparison between treatments was conducted in a hierarchical order; consequently no adjustment of the significance level (5%) for multiplicity was needed.|ANCOVA|ANCOVA model contains pre-provocation baseline, pre-dosing post-provocation craving score, and the terms treatment groups and center as fixed|Comment: The confidence interval is for the difference between treatments groups|Null hypotheses considered change in craving score means from pre-dose post-provocation at 50 seconds to be equal for the two treatment groups.||-0.99|-8.80|0.0141
71072542|NCT01846221|141654234|OTHER|||||||0.38|||||||ANOVA|||||||0.38
70940209|NCT03305458|141380710|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
70940210|NCT03305458|141380711|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
70940211|NCT03305458|141380712|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
70940212|NCT03305458|141380713|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider.|||
70940213|NCT03305458|141380714|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider.|||
71072543|NCT02052596|141654243|NON_INFERIORITY|Criteria for non-inferiority: At one month after the last vaccine dose (Month 3 or Month 5), the upper limit (UL) of the 95% confidence interval (CI) for the anti-gE antibodies GMC ratio between the Control Group and the GSK1437173A Group had to be below (\<) 1.5,|Adjusted GMC ratio|1.11|||||TWO_SIDED|95.0|1.02|1.21||||Adjustment for baseline concentration and age - pooled variance.||Demonstration of non-inferiority of the humoral immune response to two doses of the GSK1437173A vaccine when Boostrix vaccine was co-administered with the first GSK1437173A vaccine dose compared to two doses of GSK1437173A vaccine (administered separately from Boostrix vaccine), one month after the last vaccine dose.||1.21|1.02|
71072544|NCT02052596|141654244|NON_INFERIORITY|Criteria for non-inferiority: At one month after the first vaccine dose (Month 1), the upper limit (UL) of the 95% confidence interval for the GMC ratio for anti-PT antibodies of the Control Group over the GSK1437173A Group had to be \< 1.5.|Adjusted GMC ratio|1.17|||||TWO_SIDED|95.0|1.0|1.36||||Ancova model: adjustment for baseline concentration - pooled variance.||Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for pertussis toxoid (PT), one month after the vaccine dose.||1.36|1.00|
71072545|NCT02052596|141654244|NON_INFERIORITY|Criteria for non-inferiority: At one month after the first vaccine dose (Month 1), the upper limit (UL) of the 95% confidence interval for the GMC ratio for anti-FHA antibodies of the Control Group over the GSK1437173A Group had to be \< 1.5.|Adjusted GMC ratio|1.24|||||TWO_SIDED|95.0|1.07|1.44||||Adjustment for baseline concentration - pooled variance.||Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for filamentous hemagglutinin (FHA) antigen, one month after the vaccine dose.||1.44|1.07|
71072546|NCT02052596|141654244|NON_INFERIORITY|Criteria for non-inferiority: At one month after the first vaccine dose (Month 1), the upper limit (UL) of the 95% confidence interval for the GMC ratio for anti-PRN antibodies of the Control Group over the GSK1437173A Group had to be \< 1.5.|Adjusted GMC ratio|1.27|||||TWO_SIDED|95.0|1.02|1.58||||Adjustment for baseline concentration - pooled variance.||Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for pertactin (PRN) antigen, one month after the vaccine dose.||1.58|1.02|
71072547|NCT02052596|141654245|NON_INFERIORITY|Criteria for non-inferiority: At one month after the first vaccine dose (Month 1), the upper limit (UL) of the 95% confidence interval (CI) for the difference in the percentages of subjects with anti-diphtheria (anti-D) concentrations ≥ 1.0 IU/mL of the Control Group minus the GSK1437173A Group had to be \< 10%.|Difference in seropositivity rate|-0.1|||||TWO_SIDED|95.0|-3.03|2.85||||||Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for diphteria (D) antigen, one month after the vaccine dose.||2.85|-3.03|
71072548|NCT02052596|141654245|NON_INFERIORITY|Criteria for non-inferiority: At one month after the first vaccine dose (Month 1), the upper limit (UL) of the 95% confidence interval (CI) for the difference in the percentages of subjects with anti-tetanus (anti-T) concentrations ≥ 1.0 IU/mL of the Control Group minus the GSK1437173A Group had to be \< 10%.|Difference in seropositivity rate|0.01|||||TWO_SIDED|95.0|-1.18|1.27||||||Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for tetanus (T) antigen, one month after the vaccine dose.||1.27|-1.18|
70940214|NCT03305458|141380715|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider.|||
70853338|NCT04620798|141194925|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.77|1.44|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.44|0.77|
71072549|NCT00001656|141654350|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANCOVA|Covariate is baseline score||Analysis of covariance with baseline score as covariate||||.04
71072550|NCT00001656|141654351|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||ANCOVA|Covariate is baseline score||Analysis of covariance with baseline score as covariate||||0.21
71072551|NCT00001656|141654352|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANCOVA|||Analysis of covariance with baseline score as covariate||||0.35
71072552|NCT00001656|141654353|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||ANCOVA|Covariate is baseline score||Analysis of covariance with baseline score as covariate||||0.19
71072553|NCT00001656|141654354|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||ANCOVA|Covariate is baseline score||Analysis of covariance with baseline score as covariate||||0.59
71072554|NCT00001656|141654355|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||ANCOVA|||Analysis of covariance with baseline score as covariate||||0.72
71072555|NCT00001656|141654356|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||ANCOVA|Covariate is baseline score||Analysis of covariance with baseline score as covariate||||0.27
71072556|NCT00001656|141654357|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANCOVA|Covariate is baseline score||||||0.11
71072557|NCT00001656|141654358|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||t-test, 2 sided|||||||0.96
71072558|NCT00001656|141654359|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||t-test, 2 sided|||||||0.76
71072559|NCT00001656|141654361|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.73
71072560|NCT00640653|141654382|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.67||||0.03|TWO_SIDED|95.0|0.48|0.96||The significance criterion was set at alpha = .05.|generalized linear regression|Log link was specified|Treatment was coded as 1 vs health control coded as 0.|With alpha = .05, 2-tailed, and 37.4% of the control group initiating sexual intercourse by 24-month follow-up, a total sample size of 563 participants completing the trial was projected to provide power of 80% to detect a difference of 16.8% in self-reported sexual intercourse between an HIV intervention condition and the health promotion control condition.||0.96|0.48|.03
71072561|NCT02505334|141654387|SUPERIORITY|Superiority of liraglutide 1.8 mg/day vs. liraglutide 0.9 mg/day was to be considered confirmed if the 95% confidence interval for the treatment difference (liraglutide 1.8 mg/day minus liraglutide 0.9 mg/day) for change from baseline in HbA1c (% of HbA1c) was entirely below 0%, equivalent to a one-sided test with significance level of 2.5%.|Treatment difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.55|-0.24|||ANCOVA|||Missing data was imputed using the LOCF method. The change from baseline in the response after 26 weeks of treatment was analysed using an ANCOVA model with treatment as a fixed effect and baseline response as a covariate.||-0.24|-0.55|<0.0001
71072562|NCT02938949|141654455|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
71072563|NCT02938949|141654456|SUPERIORITY||||||>|0.2|||||||ANOVA|||||||> 0.20
71072564|NCT02938949|141654457|SUPERIORITY||||||>|0.2|||||||ANOVA|||||||>0.20
71072565|NCT01537068|141654519|SUPERIORITY_OR_OTHER||Test of Within-subjects effects|2.95||||0.09|TWO_SIDED||||||Mixed Models Analysis|Repeated Measures of ANOVA||||||0.09
71072566|NCT01537068|141654521|SUPERIORITY_OR_OTHER||Chi-squared|6.32||||0.025|TWO_SIDED||||||Chi-squared|||||||0.025
71072567|NCT00483704|141654522|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.54|||<|0.001|TWO_SIDED|95.0|1.8|3.58|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.58|1.80|<0.001
71072568|NCT00483704|141654522|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.001|TWO_SIDED|95.0|2.15|4.27|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.27|2.15|<0.001
71072569|NCT00483704|141654523|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.001|TWO_SIDED|95.0|2.35|3.9|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.90|2.35|<0.001
71072570|NCT00483704|141654523|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.8|||<|0.001|TWO_SIDED|95.0|2.17|3.61|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.61|2.17|<0.001
71072571|NCT00483704|141654524|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.85|||<|0.001|TWO_SIDED|95.0|2.05|7.23|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||7.23|2.05|<0.001
71072572|NCT00483704|141654524|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.18|||<|0.001|TWO_SIDED|95.0|3.36|11.39|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||11.39|3.36|<0.001
71072573|NCT00483704|141654525|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.62|||<|0.001|TWO_SIDED|95.0|1.96|3.51|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.51|1.96|<0.001
71072574|NCT00483704|141654525|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.23|||<|0.001|TWO_SIDED|95.0|2.41|4.34|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.34|2.41|<0.001
71114744|NCT01942668|141737406|SUPERIORITY||Mean Difference (Final Values)|-17.92|STANDARD_ERROR_OF_MEAN|3.8|<|0.001|TWO_SIDED|95.0|-25.39|-10.45||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-10.45|-25.39|<0.001
71072575|NCT00483704|141654526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65|||<|0.001|TWO_SIDED|95.0|1.3|2.11|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.11|1.30|<0.001
71072576|NCT00483704|141654526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67|||<|0.001|TWO_SIDED|95.0|1.31|2.14|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.14|1.31|<0.001
71072577|NCT00483704|141654527|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74|||<|0.001|TWO_SIDED|95.0|1.36|2.22|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.22|1.36|<0.001
71072578|NCT00483704|141654527|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61|||<|0.001|TWO_SIDED|95.0|1.26|2.06|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.06|1.26|<0.001
71072579|NCT00483704|141654528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67|||<|0.001|TWO_SIDED|95.0|1.28|2.17|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.17|1.28|<0.001
71072580|NCT00483704|141654528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57|||<|0.001|TWO_SIDED|95.0|1.21|2.04|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.04|1.21|<0.001
71072581|NCT00483704|141654531|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.69|||<|0.001|TWO_SIDED|95.0|1.78|4.07|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.07|1.78|<0.001
71072582|NCT00483704|141654531|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.45|||<|0.001|TWO_SIDED|95.0|2.3|5.19|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||5.19|2.30|<0.001
71072583|NCT00483704|141654532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|||<|0.001|TWO_SIDED|95.0|1.56|3.69|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.69|1.56|<0.001
71072584|NCT00483704|141654532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.37|||<|0.001|TWO_SIDED|95.0|2.22|5.12|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||5.12|2.22|<0.001
71072585|NCT00483704|141654533|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.36|||<|0.001|TWO_SIDED|95.0|1.65|3.38|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.38|1.65|<0.001
71072586|NCT00483704|141654533|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.81|||<|0.001|TWO_SIDED|95.0|1.97|4.01|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.01|1.97|<0.001
71072587|NCT00483704|141654534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.32|||<|0.001|TWO_SIDED|95.0|1.52|3.54|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.54|1.52|<0.001
71072588|NCT00483704|141654534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.02|||<|0.001|TWO_SIDED|95.0|2.0|4.56|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.56|2.00|<0.001
71072589|NCT04442269|141654535|SUPERIORITY||Mean Difference|0.201||||0.0022|TWO_SIDED|95.0|0.0768|0.3256|||Mixed Models Analysis|||||0.3256|0.0768|0.0022
71072590|NCT04450407|141654549|NON_INFERIORITY|The non-inferiority margin is 0.4%. Non-inferiority is achieved if the upper limit of the 90% CI (Confidence Interval) is below 0.4.|LS Mean Difference|0.17|||||TWO_SIDED|90.0|0.01|0.32||||||||0.32|0.01|
71072591|NCT02832375|141654561|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.45|||<|0.0001|TWO_SIDED|95.0|-0.577|-0.319|||ANCOVA|From ANCOVA model with change from baseline in Schiff Sensitivity Score as response and treatment and baseline Schiff sensitivity score as covariates.|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|H0= no difference between experimental dentifrice and control dentifrice H1= a difference between experimental dentifrice and control dentifrice||-0.319|-0.577|<0.0001
71072592|NCT06350461|141654564|NON_INFERIORITY|The non-inferiority margin is -3.|Median Difference (Final Values)|-0.324|||<|0.0001|TWO_SIDED|95.0|-1.3|0.6||One-sided test for non-inferiority|ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue.|The non-inferiority test was a priori designed to be conducted on the per-protocol (PP) population.||0.6|-1.3|<0.0001
71114745|NCT01942668|141737406|SUPERIORITY||Mean Difference (Final Values)|-12.97|STANDARD_ERROR_OF_MEAN|3.82|<|0.001|TWO_SIDED|95.0|-20.49|-5.46||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.46|-20.49|<0.001
71114746|NCT01942668|141737406|SUPERIORITY||Mean Difference (Final Values)|-14.28|STANDARD_ERROR_OF_MEAN|3.78|<|0.001|TWO_SIDED|95.0|-21.7|-6.87||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.87|-21.70|<0.001
71114747|NCT01942668|141737407|SUPERIORITY||Mean Difference (Final Values)|-21.01|STANDARD_ERROR_OF_MEAN|3.93|<|0.001|TWO_SIDED|95.0|-28.72|-13.29||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-13.29|-28.72|<0.001
71114748|NCT01942668|141737407|SUPERIORITY||Mean Difference (Final Values)|-18.37|STANDARD_ERROR_OF_MEAN|3.87|<|0.001|TWO_SIDED|95.0|-25.96|-10.78||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-10.78|-25.96|<0.001
71114749|NCT01942668|141737407|SUPERIORITY||Mean Difference (Final Values)|-13.03|STANDARD_ERROR_OF_MEAN|3.89|<|0.001|TWO_SIDED|95.0|-20.66|-5.39||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.39|-20.66|<0.001
71114750|NCT01942668|141737407|SUPERIORITY||Mean Difference (Final Values)|-14.65|STANDARD_ERROR_OF_MEAN|3.84|<|0.001|TWO_SIDED|95.0|-22.19|-7.12||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-7.12|-22.19|<0.001
71114751|NCT01942668|141737408|SUPERIORITY||Mean Difference (Final Values)|-21.83|STANDARD_ERROR_OF_MEAN|3.94|<|0.001|TWO_SIDED|95.0|-29.57|-14.08||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-14.08|-29.57|<0.001
71114752|NCT01942668|141737408|SUPERIORITY||Mean Difference (Final Values)|-19.4|STANDARD_ERROR_OF_MEAN|3.88|<|0.001|TWO_SIDED|95.0|-27.02|-11.77||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-11.77|-27.02|<0.001
70853339|NCT04620798|141194926|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.89|1.1|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.10|0.89|
71072593|NCT06350461|141654565|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.733|TWO_SIDED|95.0|-0.4|0.4|||ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue|||0.4|-0.4|0.733
71072594|NCT06350461|141654566|SUPERIORITY||Mean Difference (Final Values)|-1.52||||0.226|TWO_SIDED|95.0|-4.1|0.9|||ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue.|||0.9|-4.1|0.226
71072595|NCT06350461|141654567|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.857|TWO_SIDED|95.0|-1.8|2.1|||ANOVA|Adjusted for four dichotomous randomization strata|Direction of the difference is Discontinue - Continue|||2.1|-1.8|0.857
71072596|NCT06350461|141654568|SUPERIORITY||Mean Difference (Final Values)|0.64||||0.16|TWO_SIDED|95.0|-0.25|1.54|||t-test, 2 sided||Direction of the difference is Discontinue - Continue|||1.54|-0.25|0.16
71072597|NCT06350461|141654569|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.56|TWO_SIDED|95.0|-1.04|0.57|||t-test, 2 sided||Direction of the difference is Discontinue - Continue|||0.57|-1.04|0.56
71072598|NCT06350461|141654570|SUPERIORITY||Difference in % Participants|1.1||||0.653|TWO_SIDED|95.0|-3.7|6.1|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants initiating acute antibiotics is the same in the Discontinue and Continue arms||6.1|-3.7|0.653
71072599|NCT06350461|141654571|SUPERIORITY||Difference in % Participants|0.5||||0.622|TWO_SIDED|95.0|-2.0|3.4|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants with at least one hospitalization is the same in Discontinue and Continue arms.||3.4|-2.0|0.622
71072600|NCT06350461|141654572|SUPERIORITY||Difference in % Participants|-1.1||||0.623|TWO_SIDED|95.0|-4.1|1.6|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants with at least one protocol-defined pulmonary exacerbation is the same in Discontinue and Continue arms.||1.6|-4.1|0.623
71072601|NCT06350461|141654573|SUPERIORITY||Difference in % Participants|11.7||||0.0165|TWO_SIDED|95.0|2.4|20.7|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants with at least one AE is the same in Discontinue and Continue arms.||20.7|2.4|0.0165
71114753|NCT01942668|141737408|SUPERIORITY||Mean Difference (Final Values)|-13.98|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|95.0|-21.65|-6.32||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.32|-21.65|<0.001
71114754|NCT01942668|141737408|SUPERIORITY||Mean Difference (Final Values)|-15.66|STANDARD_ERROR_OF_MEAN|3.85|<|0.001|TWO_SIDED|95.0|-23.23|-8.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-8.10|-23.23|<0.001
71114755|NCT01942668|141737409|SUPERIORITY||Mean Difference (Final Values)|-20.61|STANDARD_ERROR_OF_MEAN|3.93|<|0.001|TWO_SIDED|95.0|-28.32|-12.89||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-12.89|-28.32|<0.001
71114756|NCT01942668|141737409|SUPERIORITY||Mean Difference (Final Values)|-18.24|STANDARD_ERROR_OF_MEAN|3.87|<|0.001|TWO_SIDED|95.0|-25.84|-10.65||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-10.65|-25.84|<0.001
71114757|NCT01942668|141737409|SUPERIORITY||Mean Difference (Final Values)|-12.62|STANDARD_ERROR_OF_MEAN|3.89||0.001|TWO_SIDED|95.0|-20.26|-4.98||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.98|-20.26|0.001
71114758|NCT01942668|141737409|SUPERIORITY||Mean Difference (Final Values)|-13.97|STANDARD_ERROR_OF_MEAN|3.84|<|0.001|TWO_SIDED|95.0|-21.51|-6.43||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.43|-21.51|<0.001
71114759|NCT01942668|141737410|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.027||0.676|TWO_SIDED|95.0|-0.04|0.07||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.07|-0.04|0.676
71114760|NCT01942668|141737410|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.027||0.436|TWO_SIDED|95.0|-0.03|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.07|-0.03|0.436
71114761|NCT01942668|141737410|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.027||0.106|TWO_SIDED|95.0|-0.01|0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.10|-0.01|0.106
71114762|NCT01942668|141737410|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.027||0.752|TWO_SIDED|95.0|-0.06|0.04||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.04|-0.06|0.752
71114763|NCT01942668|141737411|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.038||0.193|TWO_SIDED|95.0|-0.12|0.02||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.12|0.193
71114764|NCT01942668|141737411|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.037||0.319|TWO_SIDED|95.0|-0.11|0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.04|-0.11|0.319
71114765|NCT01942668|141737411|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.037||0.239|TWO_SIDED|95.0|-0.03|0.12||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.12|-0.03|0.239
70940215|NCT03305458|141380716|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
71114766|NCT01942668|141737411|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.037||0.72|TWO_SIDED|95.0|-0.09|0.06||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.06|-0.09|0.720
71114767|NCT01942668|141737412|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.049||0.03|TWO_SIDED|95.0|-0.2|-0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.20|0.030
71114768|NCT01942668|141737412|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.048||0.06|TWO_SIDED|95.0|-0.19|0.0||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.00|-0.19|0.060
71114769|NCT01942668|141737412|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.048||0.506|TWO_SIDED|95.0|-0.06|0.13||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.13|-0.06|0.506
71114770|NCT01942668|141737412|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.048||0.232|TWO_SIDED|95.0|-0.15|0.04||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.04|-0.15|0.232
70940216|NCT03305458|141380717|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
71114771|NCT01942668|141737413|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.058||0.027|TWO_SIDED|95.0|-0.24|-0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.24|0.027
71114772|NCT01942668|141737413|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.057||0.011|TWO_SIDED|95.0|-0.26|-0.03||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.03|-0.26|0.011
71114773|NCT01942668|141737413|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.057||0.71|TWO_SIDED|95.0|-0.13|0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.09|-0.13|0.710
70853340|NCT04620798|141194926|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.5|1.62|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.62|0.50|
70940217|NCT03305458|141380718|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
70940218|NCT03305458|141380719|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
71114774|NCT01942668|141737413|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.057||0.072|TWO_SIDED|95.0|-0.21|0.01||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.01|-0.21|0.072
71114775|NCT01942668|141737414|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.069|<|0.001|TWO_SIDED|95.0|-0.36|-0.09||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.09|-0.36|<0.001
71114776|NCT01942668|141737414|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.068||0.062|TWO_SIDED|95.0|-0.26|0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.01|-0.26|0.062
71114777|NCT01942668|141737414|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.068||0.886|TWO_SIDED|95.0|-0.12|0.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.14|-0.12|0.886
71114778|NCT01942668|141737414|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.067||0.067|TWO_SIDED|95.0|-0.26|0.01||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.01|-0.26|0.067
71114779|NCT01942668|141737415|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.084|<|0.001|TWO_SIDED|95.0|-0.53|-0.2||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.20|-0.53|<0.001
71114780|NCT01942668|141737415|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.082||0.053|TWO_SIDED|95.0|-0.32|0.0||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.00|-0.32|0.053
70940219|NCT03305458|141380720|SUPERIORITY||||||||||||||||||response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider.|||
70940220|NCT03305458|141380721|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
71114781|NCT01942668|141737415|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.083||0.413|TWO_SIDED|95.0|-0.23|0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.09|-0.23|0.413
71114782|NCT01942668|141737415|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.082||0.018|TWO_SIDED|95.0|-0.35|-0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.03|-0.35|0.018
71114783|NCT01942668|141737416|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.085|<|0.001|TWO_SIDED|95.0|-0.54|-0.2||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.20|-0.54|<0.001
70940221|NCT03305458|141380722|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
70940222|NCT03305458|141380723|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
70940223|NCT03305458|141380724|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
70940224|NCT03305458|141380725|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
70940225|NCT05431543|141380726|SUPERIORITY||Odds Ratio (OR)|83.988|||<|0.0001|TWO_SIDED||||||Generalized Estimating Equation (GEE)|||||||<0.0001
70940226|NCT05431543|141380726|SUPERIORITY||Odds Ratio (OR)|102.093|||<|0.0001|TWO_SIDED||||||Generalized Estimating Equation (GEE)|||||||<0.0001
70940227|NCT00914732|141380734|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation (Liquid SC Group) and IMVAMUNE® (1x10\^8 TCID50) lyophilized formulation (Lyophilized SC) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Lyophilized SC was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|-0.74|||||TWO_SIDED|97.5|-1.23|-0.25||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable||-0.25|-1.23|
70940228|NCT00914732|141380735|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation (Liquid SC Group) and IMVAMUNE® (1x10\^8 TCID50) lyophilized formulation (Lyophilized SC) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Lyophilized SC was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|-0.83|||||TWO_SIDED|97.5|-1.32|-0.33||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable||-0.33|-1.32|
71072602|NCT06350461|141654574|SUPERIORITY||Rate Ratio|1.29||||0.0958|TWO_SIDED|95.0|0.96|1.74|||Poisson Regression|||Rate ratio, confidence interval, and p-value calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks in the HS-discontinue and HS-continue arms are 1135.7 and 1163.9 weeks, respectively. Ratio is Discontinue / Continue.||1.74|0.96|0.0958
71072603|NCT06350461|141654575|SUPERIORITY||Difference in % Participants|2.17||||0.1215|TWO_SIDED|95.0|-0.7|5.7|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants changing assigned regimen is the same in Discontinue and Continue arms.||5.7|-0.7|0.1215
70940229|NCT00914732|141380736|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation subcutaneously (Liquid SC Group) and IMVAMUNE® (2x10\^7 TCID50) formulation intradermally (Liquid ID) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Liquid ID was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|0.05|||||TWO_SIDED|97.5|-0.43|0.52||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable.||0.52|-0.43|
70940230|NCT00914732|141380737|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation subcutaneously (Liquid SC Group) and IMVAMUNE® (2x10\^7 TCID50) formulation intradermally (Liquid ID) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Liquid ID was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|-0.27|||||TWO_SIDED|97.5|-0.77|0.23||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable.||0.23|-0.77|
71072604|NCT00962091|141654606|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.9|||||TWO_SIDED|90.0|1.52|2.37|||||The CIs are calculated for the difference in the LS means of the ln-transformed Day 1 Cmax values (difference=OS-PIC). Antilogs of the confidence limits for the difference are taken to construct the CIs for the ratio of the geometric means.|||2.37|1.52|
70853341|NCT04620798|141194927|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.96|1.06|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.06|0.96|
70940231|NCT00914732|141380740|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation subcutaneously (Liquid SC Group) and IMVAMUNE® (2x10\^7 TCID50) formulation intradermally (Liquid ID) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Liquid ID was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|0.34|||||TWO_SIDED|97.5|-0.3|0.71||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable.||0.71|-0.3|
70940232|NCT00914732|141380741|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation subcutaneously (Liquid SC Group) and IMVAMUNE® (2x10\^7 TCID50) formulation intradermally (Liquid ID) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Liquid ID was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|0.02|||||TWO_SIDED|97.5|-0.31|0.35||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable.||0.35|-0.31|
71072605|NCT00962091|141654607|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.38|||||TWO_SIDED|90.0|1.08|1.78|||||The CIs are calculated for the difference in the LS means of the ln-transformed Day 1 AUClast values (difference=OS-PIC). Antilogs of the confidence limits for the difference are taken to construct the CIs for the ratio of the geometric means.|||1.78|1.08|
71072606|NCT00962091|141654613|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.84|||||TWO_SIDED|90.0|0.66|1.06|||||The CIs are calculated for the difference in the LS means of the ln-transformed Day 1 Cmax values (difference=Fed-Fasted). Antilogs of the confidence limits for the difference are taken to construct the CIs for the ratio of the geometric means.|||1.06|0.66|
71072607|NCT00962091|141654614|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.04|||||TWO_SIDED|90.0|0.8|1.34|||||The CIs are calculated for the difference in the LS means of the ln-transformed Day 1 AUClast values (difference=Fed-Fasted). Antilogs of the confidence limits for the difference are taken to construct the CIs for the ratio of the geometric means.|||1.34|0.80|
71072608|NCT00962091|141654615|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.94|||||TWO_SIDED|90.0|0.68|1.32|||||The CIs are calculated for the difference in the LS means of the ln-transformed Day 1 AUC values (difference=Fed-Fasted). Antilogs of the confidence limits for the difference are taken to construct the CIs for the ratio of the geometric means.|||1.32|0.68|
71072609|NCT04216589|141654620|OTHER|This was a single arm trial.|Mean Difference (Net)|-4.24|STANDARD_DEVIATION|4.05|<|0.001|TWO_SIDED|95.0|-5.41|-3.06|||Regression, Linear|||The study was powered to detect an absolute IHTG change of -5% assuming a null change of 0%, a standard deviation of absolute IHTG change of 9%, and 37 evaluable participants.||-3.06|-5.41|<0.001
71072610|NCT04216589|141654621|OTHER|This was a single arm trial.|Mean Difference (Net)|-31.33|STANDARD_DEVIATION|26.5|<|0.001|TWO_SIDED|95.0|-39.04|-23.62||No adjustment for multiple comparisons|Regression, Linear|||||-23.62|-39.04|<0.001
71072611|NCT04216589|141654625|OTHER|This was a single arm trial.|Mean Difference (Net)|-2.77|STANDARD_DEVIATION|2.05|<|0.001|TWO_SIDED|95.0|-3.36|-2.17||Not adjusted for multiple comparisons.|Regression, Linear|||||-2.17|-3.36|<0.001
71072612|NCT04216589|141654626|OTHER|This was a single arm trial.|Mean Difference (Net)|-2.15|STANDARD_DEVIATION|1.38|<|0.001|TWO_SIDED|95.0|-2.55|-1.75||Not adjusted for multiple comparisons|Regression, Linear|||||-1.75|-2.55|<0.001
71072613|NCT04216589|141654627|OTHER|This was a single arm trial.|Mean Difference (Net)|-7.8|STANDARD_DEVIATION|5.77|<|0.001|TWO_SIDED|95.0|-9.48|-6.13||Not adjusted for multiple comparisons|Regression, Linear|||||-6.13|-9.48|<0.001
71072614|NCT04216589|141654628|OTHER|This was a single arm trial.|Mean Difference (Net)|-6.16|STANDARD_DEVIATION|3.96|<|0.001|TWO_SIDED|95.0|-7.3|-5.03||Not adjusted for multiple comparisons|Regression, Linear|||||-5.03|-7.30|<0.001
71072615|NCT04216589|141654629|OTHER|This was a single arm trial.|Mean Difference (Net)|-6.66|STANDARD_DEVIATION|6.47|<|0.001|TWO_SIDED|95.0|-8.54|-4.78||Not adjusted for multiple comparisons|Regression, Linear|||||-4.78|-8.54|<0.001
70853342|NCT04620798|141194927|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.74|1.31|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.31|0.74|
71072616|NCT04216589|141654630|OTHER|This was a single arm trial.|Mean Difference (Net)|-5.53|STANDARD_DEVIATION|5.3|<|0.001|TWO_SIDED|95.0|-7.07|-3.99||Not adjusted for multiple comparisons|Regression, Linear|||||-3.99|-7.07|<0.001
71072617|NCT04216589|141654631|OTHER|This was a single arm trial.|Mean Difference (Net)|-1.46|STANDARD_DEVIATION|5.82||0.092|TWO_SIDED|95.0|-3.17|0.25||Not adjusted for multiple comparisons|Regression, Linear|||||0.25|-3.17|0.092
71072618|NCT04216589|141654633|OTHER|This was a single arm trial.|Mean Difference (Net)|-0.25|STANDARD_DEVIATION|0.259|<|0.001|TWO_SIDED|95.0|-0.32|-0.17||Not adjusted for multiple comparisons|Regression, Linear|||||-0.17|-0.32|< 0.001
71072619|NCT04216589|141654634|OTHER|This was a single arm trial.|Mean Difference (Net)|-9.9|STANDARD_DEVIATION|16.6|<|0.001|TWO_SIDED|95.0|-14.7|-5.09||Not adjusted for multiple comparisons|Regression, Linear|||||-5.09|-14.70|<0.001
71072620|NCT04216589|141654635|OTHER|This was a single arm trial.|Mean Difference (Net)|-8.87|STANDARD_DEVIATION|11.5|<|0.001|TWO_SIDED|95.0|-12.26|-5.48||Not adjusted for multiple comparisons|Regression, Linear|||||-5.48|-12.26|<0.001
71072621|NCT04216589|141654636|OTHER|This was a single arm trial.|Mean Difference (Net)|-3.98|STANDARD_DEVIATION|23.1||0.25|TWO_SIDED|95.0|-10.84|2.89||Not adjusted for multiple comparisons|Regression, Linear|||||2.89|-10.84|0.25
71072622|NCT04216589|141654637|OTHER|This was a single arm trial.|Mean Difference (Net)|-11.93|STANDARD_DEVIATION|26.4||0.004|TWO_SIDED|95.0|-19.79|-4.08||Not adjusted for multiple comparisons|Regression, Linear|||||-4.08|-19.79|0.004
71072623|NCT04216589|141654638|OTHER|This was a single arm trial.|Mean Difference (Net)|-1.04|STANDARD_DEVIATION|20.5||0.73|TWO_SIDED|95.0|-7.14|5.05||Not adjusted for multiple comparisons|Regression, Linear|||||5.05|-7.14|0.73
71072624|NCT04216589|141654639|OTHER|This was a single arm trial.|Mean Difference (Net)|-6.91|STANDARD_DEVIATION|23.1||0.051|TWO_SIDED|95.0|-13.85|0.03||Not adjusted for multiple comparisons|Regression, Linear|||||0.03|-13.85|0.051
70853343|NCT04620798|141194928|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.84|1.09|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.09|0.84|
71072625|NCT04216589|141654640|OTHER|This was a single arm trial.|Mean Difference (Net)|2.04|STANDARD_DEVIATION|6.96||0.053|TWO_SIDED|95.0|-0.02|4.11||Not adjusted for multiple comparisons|Regression, Linear|||||4.11|-0.02|0.053
71072626|NCT04216589|141654641|OTHER|This was a single arm trial.|Mean Difference (Net)|-0.78|STANDARD_DEVIATION|6.66||0.43|TWO_SIDED|95.0|-2.76|1.2||Not adjusted for multiple comparisons|Regression, Linear|||||1.20|-2.76|0.43
71072627|NCT04216589|141654642|OTHER|This was a single arm trial.|Mean Difference (Net)|-26.78|STANDARD_DEVIATION|64.8||0.007|TWO_SIDED|95.0|-46.04|-7.53||Not adjusted for multiple comparisons|Regression, Linear|||||-7.53|-46.04|0.007
71072628|NCT04216589|141654643|OTHER|This was a single arm trial.|Mean Difference (Net)|-18.65|STANDARD_DEVIATION|49.3||0.014|TWO_SIDED|95.0|-33.29|-4.01||Not adjusted for multiple comparisons|Regression, Linear|||||-4.01|-33.29|0.014
70853344|NCT04620798|141194928|SUPERIORITY||Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.33|1.72|||||"This analysis compares the probability of a response of Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.72|0.33|
70853345|NCT04620798|141194929|SUPERIORITY||Risk Ratio (RR)|0.87|||||TWO_SIDED|95.0|0.74|1.04|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.04|0.74|
70940233|NCT00914732|141380742|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation (Liquid SC Group) and IMVAMUNE® (1x10\^8 TCID50) lyophilized formulation (Lyophilized SC) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Lyophilized SC was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|-0.35|||||TWO_SIDED|97.5|-0.74|0.04||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable.||0.04|-0.74|
70940234|NCT00914732|141380743|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x108 TCID50) liquid formulation (Liquid SC Group) and IMVAMUNE® (1x108 TCID50) lyophilized formulation (Lyophilized SC) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Lyophilized SC was considered non-inferior to the Lyophilized SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|-0.47|||||TWO_SIDED|97.5|-0.81|-0.12||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable.||-0.12|-0.81|
70940235|NCT00141271|141380792|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6409||||||Hochberg's adjustment was used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.6409
70853346|NCT04620798|141194929|SUPERIORITY||Risk Ratio (RR)|1.4|||||TWO_SIDED|95.0|0.6|3.25|||||"This analysis compares the probability of a response of Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||3.25|0.60|
70853347|NCT04620798|141194930|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.99|1.03|||||"This analysis compares the probability of a response of Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.03|0.99|
70853348|NCT04620798|141194930|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.77|1.21|||||"This analysis compares the probability of a response of Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.21|0.77|
70940236|NCT00141271|141380792|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.0140
70853349|NCT04620798|141194931|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.97|1.06|||||"This analysis compares the probability of a response of Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.06|0.97|
70853350|NCT04620798|141194931|SUPERIORITY||Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.6|1.11|||||"This analysis compares the probability of a response of Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.11|0.60|
70853351|NCT04620798|141194932|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.97|1.04|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.04|0.97|
70940237|NCT00141271|141380792|SUPERIORITY_OR_OTHER_LEGACY|||||||0.484||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.4840
70940238|NCT00141271|141380792|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4444||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.4444
71072629|NCT04216589|141654644|OTHER|This was a single arm trial.|Risk Ratio (RR)|0.72||||0.016|TWO_SIDED|95.0|0.55|0.94||Not adjusted for multiple comparisons.|GEE model for repeated binary outcomes|The GEE model used a log link and an unstructured correlation.|The risk ratio is comparing the estimated risk at Week 12 (0.55; 95% CI: 0.43, 0.72) to estimated risk at Baseline (0.77; 95% CI: 0.67, 0.90).|Comparison between Baseline and Week 12.||0.94|0.55|0.016
71072630|NCT04216589|141654644|OTHER|This was a single arm trial.|Risk Ratio (RR)|0.75||||0.033|TWO_SIDED|95.0|0.58|0.98||Not adjusted for multiple comparisons.|GEE model for repeated binary outcomes|The GEE model used a log link and an unstructured correlation.|The risk ratio is comparing the estimated risk at Week 24 (0.58; 95% CI: 0.46, 0.74) to estimated risk at Baseline (0.77; 95% CI: 0.67, 0.90).|Comparison between Baseline and Week 24.||0.98|0.58|0.033
71072631|NCT02326298|141654651|SUPERIORITY||Odds Ratio (OR)|28.962|||<|0.0001|TWO_SIDED|97.5|6.968|120.371||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose versus (vs) PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||120.371|6.968|<0.0001
71072632|NCT02326298|141654651|SUPERIORITY||Odds Ratio (OR)|45.66|||<|0.0001|TWO_SIDED|97.5|10.657|195.634||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||195.634|10.657|<0.0001
71072633|NCT02326298|141654651|SUPERIORITY||Estimated difference in responder rate|60.0|||||TWO_SIDED|95.0|47.92|72.17|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95% CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||72.17|47.92|
71072634|NCT02326298|141654651|SUPERIORITY||Estimated difference in responder rate|69.3|||||TWO_SIDED|95.0|57.65|80.99|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95% CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||80.99|57.65|
71072635|NCT02326298|141654652|SUPERIORITY||Odds Ratio (OR)|20.116|||<|0.0001|TWO_SIDED|97.5|3.699|109.399||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||109.399|3.699|<0.0001
71072636|NCT02326298|141654652|SUPERIORITY||Odds Ratio (OR)|31.143|||<|0.0001|TWO_SIDED|97.5|5.687|170.548||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||170.548|5.687|<0.0001
71072637|NCT02326298|141654652|SUPERIORITY||Estimated difference in responder rate|42.8|||||TWO_SIDED|95.0|30.7|54.86|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95% CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||54.86|30.70|
71072638|NCT02326298|141654652|SUPERIORITY||Estimated difference in responder rate|53.6|||||TWO_SIDED|95.0|41.33|65.94|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95% CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||65.94|41.33|
71072639|NCT02326298|141654653|SUPERIORITY||Odds Ratio (OR)|36.668|||<|0.0001|TWO_SIDED|97.5|5.717|235.193||The p-value for this analysis as used in the fixed sequence testing procedure was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment,region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||235.193|5.717|<0.0001
70940239|NCT00141271|141380792|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8129||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.8129
70940240|NCT00141271|141380792|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1105||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.1105
70940241|NCT00141271|141380792|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9582||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.9582
71072640|NCT02326298|141654653|SUPERIORITY||Odds Ratio (OR)|50.606|||<|0.0001|TWO_SIDED|97.5|7.88|324.988||The p-value for this analysis as used in the fixed sequence testing procedure was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||324.988|7.880|<0.0001
71072641|NCT02326298|141654653|SUPERIORITY||Estimated difference in responder rate|35.4|||||TWO_SIDED|95.0|20.85|49.87|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95% CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||49.87|20.85|
71072642|NCT02326298|141654653|SUPERIORITY||Estimated difference in responder rate|43.1|||||TWO_SIDED|95.0|27.56|58.71|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95% CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||58.71|27.56|
71072643|NCT02326298|141654654|SUPERIORITY||Adjusted Mean Treatment Differences|-6.0|||<|0.0001|TWO_SIDED|97.5|-8.18|-3.81||P-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group, region, prior biologic exposure as factors; Baseline DLQI score as a covariate.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||-3.81|-8.18|<0.0001
71072644|NCT02326298|141654654|SUPERIORITY||Ajusted Mean Treatment Differences|-6.84|||<|0.0001|TWO_SIDED|97.5|-9.05|-4.62||P-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group, region, prior biologic exposure as factors; Baseline DLQI score as a covariate.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||-4.62|-9.05|<0.0001
71072645|NCT03191864|141654657|SUPERIORITY|||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
71072646|NCT03191864|141654657|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71114784|NCT01942668|141737416|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.083||0.006|TWO_SIDED|95.0|-0.4|-0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.07|-0.40|0.006
71072647|NCT03191864|141654657|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71072648|NCT03191864|141654657|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71072649|NCT03191864|141654659|OTHER||Mean Difference (Final Values)|-1.28||||0.02|TWO_SIDED|90.0|-2.29|-0.26|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparisons of each APT-1011 dose group to Placebo at Week 12 are from an ANCOVA model||-0.26|-2.29|0.020
71072650|NCT03191864|141654659|OTHER||Mean Difference (Final Values)|-2.08|||<|0.001|TWO_SIDED|90.0|-3.07|-1.1|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparisons of each APT-1011 dose group to Placebo at Week 12 are from an ANCOVA model||-1.10|-3.07|<0.001
71072651|NCT03191864|141654659|OTHER||Mean Difference (Final Values)|-2.25|||<|0.001|TWO_SIDED|90.0|-3.23|-1.26|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparisons of each APT-1011 dose group to Placebo at Week 12 are from an ANCOVA model||-1.26|-3.23|<0.001
71072652|NCT03191864|141654659|OTHER||Mean Difference (Final Values)|-1.59||||0.005|TWO_SIDED|90.0|-2.59|-0.59|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparisons of each APT-1011 dose group to Placebo at Week 12 are from an ANCOVA model||-0.59|-2.59|0.005
70853352|NCT04620798|141194932|SUPERIORITY||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.74|1.12|||||"This analysis compares the probability of a response of Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.12|0.74|
71072653|NCT03191864|141654661|OTHER||Mean Difference (Final Values)|-1.19||||0.067|TWO_SIDED|90.0|-2.49|0.12|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparison of each APT-1011 dose group to placebo at Week 12 are from an ANCOVA model.||0.12|-2.49|0.067
71114785|NCT01942668|141737416|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.084||0.072|TWO_SIDED|95.0|-0.32|0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.01|-0.32|0.072
71072654|NCT03191864|141654661|OTHER||Mean Difference (Final Values)|0.34||||0.672|TWO_SIDED|90.0|-0.91|1.59|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparison of each APT-1011 dose group to placebo at Week 12 are from an ANCOVA model.||1.59|-0.91|0.672
71072655|NCT03191864|141654661|OTHER||Mean Difference (Final Values)|-1.28||||0.048|TWO_SIDED|90.0|-2.55|-0.01|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparison of each APT-1011 dose group to placebo at Week 12 are from an ANCOVA model.||-0.01|-2.55|0.048
70853353|NCT04620798|141194933|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.52|1.71|||||This analysis compares the probability of seroconverting during the study period. The reference group for this analysis was the control (delayed results) group.|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and seroconversion. The reference group for this analysis was the control (delayed results) group.||1.71|0.52|
70853354|NCT01960907|141194942|SUPERIORITY_OR_OTHER|||||||0.342|||||||Log Rank|||||||0.342
70853355|NCT01960907|141194943|SUPERIORITY_OR_OTHER|||||||0.915|||||||t-test, 2 sided|||||||0.915
70853356|NCT01960907|141194944|SUPERIORITY_OR_OTHER|||||||0.038|||||||Wilcoxon (Mann-Whitney)|||||||0.038
70853357|NCT01185353|141194971|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori p-value significance threshold: 1-sided ≤0.10|Regression, Logistic|||||||<0.001
70853358|NCT01185353|141194973|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||0.045
70853359|NCT01185353|141194973|SUPERIORITY_OR_OTHER|||||||0.088|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||0.088
70853360|NCT01185353|141194973|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||<0.001
70853361|NCT01185353|141194973|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||<0.001
70853362|NCT01185353|141194975|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||0.003
70853363|NCT01185353|141194975|SUPERIORITY_OR_OTHER|||||||0.162|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||0.162
70853364|NCT01185353|141194975|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||<0.001
70853365|NCT01185353|141194975|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||<0.001
70853366|NCT01185353|141194977|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||0.017
70853367|NCT01185353|141194977|SUPERIORITY_OR_OTHER|||||||0.109|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||0.109
70853368|NCT01185353|141194977|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||<0.001
70853369|NCT01185353|141194977|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||<0.001
70853370|NCT01185353|141194981|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||P-value is for TJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.480
70853371|NCT01185353|141194981|SUPERIORITY_OR_OTHER|||||||0.064|TWO_SIDED|||||P-value is for TJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.064
70940242|NCT00141271|141380792|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1893||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.1893
70940243|NCT00141271|141380792|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2924||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Hochberg's adjustment used for multiple comparisons adjustment||Week 5||||0.2924
70853372|NCT01185353|141194981|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for TJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
70853373|NCT01185353|141194981|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value is for TJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.001
70853374|NCT01185353|141194981|SUPERIORITY_OR_OTHER|||||||0.116|TWO_SIDED|||||P-value is for SJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.116
70853375|NCT01185353|141194981|SUPERIORITY_OR_OTHER|||||||0.201|TWO_SIDED|||||P-value is for SJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.201
70853376|NCT01185353|141194981|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for SJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
70853377|NCT01185353|141194981|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||P-value is for SJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.002
70853378|NCT01185353|141194983|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.003
70853379|NCT01185353|141194983|SUPERIORITY_OR_OTHER|||||||0.167|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.167
70853380|NCT01185353|141194983|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
70853381|NCT01185353|141194983|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.001
70853382|NCT01185353|141194985|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.016
70853383|NCT01185353|141194985|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.108
70940244|NCT00141271|141380792|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1897||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.1897
70940245|NCT00141271|141380792|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6608||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||"Week 6 An estimated sample size of 180 was needed per treatment arm in order to achieve 85% power to detect a treatment difference of 3.5 in the mean change from baseline to Week 6 in MADRS total score with a two-sided t-test at the 0.05 significance level. The common standard deviation was estimated as 11.0.~The null hypotheses for the primary parameter is equality of mean change from baseline to Week 6 in MADRS total score between ziprasidone and placebo groups."||||0.6608
71072656|NCT03191864|141654661|OTHER||Mean Difference (Final Values)|0.31||||0.653|TWO_SIDED|90.0|-0.98|1.59|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparison of each APT-1011 dose group to placebo at Week 12 are from an ANCOVA model.||1.59|-0.98|0.653
71072657|NCT03191864|141654663|SUPERIORITY||Mean Difference (Final Values)|-8.81||||0.079|TWO_SIDED|90.0|-19.06|1.45|||ANCOVA|||EEsAI Total Score Change from Baseline Week 12||1.45|-19.06|0.079
71072658|NCT03191864|141654663|SUPERIORITY||Mean Difference (Final Values)|-5.18||||0.195|TWO_SIDED|90.0|-15.14|4.78|||ANCOVA|||EEsAI Total Score Change from Baseline Week 12||4.78|-15.14|0.195
71072659|NCT03191864|141654663|SUPERIORITY||Mean Difference (Final Values)|-12.56||||0.02|TWO_SIDED|90.0|-22.55|-2.58|||ANCOVA|||EEsAI Total Score Change from Baseline Week 12||-2.58|-22.55|0.020
71072660|NCT03191864|141654663|SUPERIORITY||Mean Difference (Final Values)|-10.61||||0.043|TWO_SIDED|90.0|-20.74|-0.48|||ANCOVA|||EEsAI Total Score Change from Baseline Week 12||-0.48|-20.74|0.043
71072661|NCT03191864|141654664|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.459|TWO_SIDED|90.0|-3.49|3.08|||ANCOVA|||VDQ Score Change from Baseline Week 12||3.08|-3.49|0.459
71072662|NCT03191864|141654664|SUPERIORITY||Mean Difference (Final Values)|0.58||||0.617|TWO_SIDED|90.0|-2.65|3.8|||ANCOVA|||VDQ Score Change from Baseline Week 12||3.80|-2.65|0.617
71114786|NCT01942668|141737416|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.083||0.014|TWO_SIDED|95.0|-0.37|-0.04||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.04|-0.37|0.014
70853384|NCT01185353|141194985|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.008
71072663|NCT03191864|141654664|SUPERIORITY||Mean Difference (Final Values)|-1.87||||0.167|TWO_SIDED|90.0|-5.07|1.33|||ANCOVA|||VDQ Score Change from Baseline Week 12||1.33|-5.07|0.167
71114787|NCT01942668|141737417|SUPERIORITY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.087|<|0.001|TWO_SIDED|95.0|-0.55|-0.21||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.21|-0.55|<0.001
71114788|NCT01942668|141737417|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.085||0.016|TWO_SIDED|95.0|-0.37|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.04|-0.37|0.016
71114789|NCT01942668|141737417|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.086||0.169|TWO_SIDED|95.0|-0.29|0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.05|-0.29|0.169
71114790|NCT01942668|141737417|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.085||0.081|TWO_SIDED|95.0|-0.31|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.31|0.081
71114791|NCT01942668|141737418|SUPERIORITY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.092|<|0.001|TWO_SIDED|95.0|-0.66|-0.3||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.30|-0.66|<0.001
71072664|NCT03191864|141654664|SUPERIORITY||Mean Difference (Final Values)|-0.63||||0.373|TWO_SIDED|90.0|-3.88|2.61|||ANCOVA|||VDQ Score Change from Baseline Week 12||2.61|-3.88|0.373
71072665|NCT03191864|141654664|SUPERIORITY||Mean Difference (Final Values)|-1.66||||0.203|TWO_SIDED|90.0|-4.96|1.64|||ANCOVA|||AMS Score Change from Baseline Week 12||1.64|-4.96|0.203
71072666|NCT03191864|141654664|SUPERIORITY||Mean Difference (Final Values)|-4.33||||0.014|TWO_SIDED|90.0|-7.54|-1.13|||ANCOVA|||AMS Score Change from Baseline Week 12||-1.13|-7.54|0.014
71072667|NCT03191864|141654664|SUPERIORITY||Mean Difference (Final Values)|-3.02||||0.061|TWO_SIDED|90.0|-6.23|0.2|||ANCOVA|||AMS Score Change from Baseline Week 12||0.20|-6.23|0.061
71114792|NCT01942668|141737418|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.091||0.003|TWO_SIDED|95.0|-0.45|-0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.10|-0.45|0.003
70853385|NCT01185353|141194985|SUPERIORITY_OR_OTHER|||||||0.368|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.368
70853386|NCT01185353|141194987|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.039
70853387|NCT01185353|141194987|SUPERIORITY_OR_OTHER|||||||0.458|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.458
70853388|NCT01185353|141194987|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.008
71072668|NCT03191864|141654664|SUPERIORITY||Mean Difference (Final Values)|-2.57||||0.097|TWO_SIDED|90.0|-5.83|0.69|||ANCOVA|||AMS Score Change from Baseline Week 12||0.69|-5.83|0.097
71072669|NCT02086682|141654678|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.79
70940246|NCT00141271|141380792|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2148||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||"Week 6 An estimated sample size of 180 was needed per treatment arm in order to achieve 85% power to detect a treatment difference of 3.5 in the mean change from baseline to Week 6 in MADRS total score with a two-sided t-test at the 0.05 significance level. The common standard deviation was estimated as 11.0.~The null hypotheses for the primary parameter is equality of mean change from baseline to Week 6 in MADRS total score between ziprasidone and placebo groups."||||0.2148
70940247|NCT00141271|141380792|SUPERIORITY_OR_OTHER_LEGACY|||||||0.529||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.5290
71114793|NCT01942668|141737418|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.091||0.022|TWO_SIDED|95.0|-0.39|-0.03||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.03|-0.39|0.022
71114794|NCT01942668|141737418|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.09||0.006|TWO_SIDED|95.0|-0.43|-0.07||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.07|-0.43|0.006
70940248|NCT00141271|141380792|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0811||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.0811
71114795|NCT01942668|141737419|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.096|<|0.001|TWO_SIDED|95.0|-0.71|-0.33||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.33|-0.71|<0.001
71114796|NCT01942668|141737419|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.095||0.007|TWO_SIDED|95.0|-0.44|-0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.07|-0.44|0.007
71114797|NCT01942668|141737419|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.095||0.038|TWO_SIDED|95.0|-0.39|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.39|0.038
71114798|NCT01942668|141737419|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.094||0.283|TWO_SIDED|95.0|-0.29|0.08||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.08|-0.29|0.283
71114799|NCT01942668|141737420|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.72|-0.34||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.34|-0.72|<0.001
70853389|NCT01185353|141194987|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.029
70940249|NCT00141271|141380793|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2287||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1||||0.2287
70940250|NCT00141271|141380793|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4734||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week1||||0.4734
70940251|NCT00141271|141380793|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7401||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.7401
70940252|NCT00141271|141380793|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7904||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.7904
71114800|NCT01942668|141737420|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.097|<|0.001|TWO_SIDED|95.0|-0.54|-0.16||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.16|-0.54|<0.001
71114801|NCT01942668|141737420|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.098||0.027|TWO_SIDED|95.0|-0.41|-0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.02|-0.41|0.027
71114802|NCT01942668|141737420|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.096||0.071|TWO_SIDED|95.0|-0.36|0.01||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.01|-0.36|0.071
71114803|NCT01942668|141737421|SUPERIORITY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.101|<|0.001|TWO_SIDED|95.0|-0.77|-0.37||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.37|-0.77|<0.001
71114804|NCT01942668|141737421|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.57|-0.18||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.18|-0.57|<0.001
70853390|NCT01185353|141194989|SUPERIORITY_OR_OTHER|||||||0.217|TWO_SIDED|||||P-value is for Physician's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.217
71114805|NCT01942668|141737421|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.1||0.039|TWO_SIDED|95.0|-0.4|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.40|0.039
71114806|NCT01942668|141737421|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.099||0.088|TWO_SIDED|95.0|-0.36|0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.03|-0.36|0.088
71114807|NCT01942668|141737422|SUPERIORITY|||||||0.85||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.850
71114808|NCT01942668|141737422|SUPERIORITY|||||||0.622||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||0.622
71114809|NCT01942668|141737422|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||1.000
71114810|NCT01942668|141737422|SUPERIORITY|||||||0.374||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||0.374
71114811|NCT01942668|141737422|SUPERIORITY|||||||0.706||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.706
71114812|NCT01942668|141737422|SUPERIORITY|||||||0.372||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||0.372
71114813|NCT01942668|141737422|SUPERIORITY|||||||0.316||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.316
71114814|NCT01942668|141737422|SUPERIORITY|||||||0.221||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||0.221
70940253|NCT00141271|141380793|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5274||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.5274
70940254|NCT00141271|141380793|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1059||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.1059
71114815|NCT01942668|141737423|SUPERIORITY|||||||0.283||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.283
71114816|NCT01942668|141737423|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.004
70940255|NCT00141271|141380793|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8871||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.8871
71114817|NCT01942668|141737423|SUPERIORITY|||||||0.68||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.680
71114818|NCT01942668|141737423|SUPERIORITY|||||||0.232||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.232
71114819|NCT01942668|141737423|SUPERIORITY|||||||0.677||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.677
71114820|NCT01942668|141737423|SUPERIORITY|||||||0.073||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.073
71114821|NCT01942668|141737423|SUPERIORITY|||||||0.301||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.301
71114822|NCT01942668|141737423|SUPERIORITY|||||||0.013||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.013
71114823|NCT01942668|141737424|SUPERIORITY|||||||0.003||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.003
71114824|NCT01942668|141737424|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||<0.001
71114825|NCT01942668|141737424|SUPERIORITY|||||||0.135||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.135
71114826|NCT01942668|141737424|SUPERIORITY|||||||0.231||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||0.231
71114827|NCT01942668|141737424|SUPERIORITY|||||||0.377||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.377
71114828|NCT01942668|141737424|SUPERIORITY|||||||0.478||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||0.478
70940256|NCT00141271|141380793|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6939|||||||Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.6939
71072670|NCT04231396|141654679|SUPERIORITY||Mean Difference (Final Values)|0.1456||||0.037|TWO_SIDED|95.0|0.012|0.279|||t-test, 1 sided|||The SNR Loss scores computed the means per client and week (1-12), with a smoothing method: isotonic regression (isoreg, via R). The slopes (lsfit, via R) calculated of the smoothed means separately per client, per 7-9 weeks (early training weeks), and per 10-12 weeks (final training weeks). This created slope differences, per client.||.279|.012|.037
70853391|NCT01185353|141194989|SUPERIORITY_OR_OTHER|||||||0.092|TWO_SIDED|||||P-value is for Physician's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.092
70940257|NCT00141271|141380793|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1044||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.1044
70940258|NCT00141271|141380793|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3132||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.3132
71072671|NCT00715104|141654726|SUPERIORITY_OR_OTHER||% Subjects with 2-fold increase|16.2||||1|TWO_SIDED|95.0|1.7|30.7||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD3+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD3+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||30.7|1.7|1.000
71072672|NCT00715104|141654726|SUPERIORITY_OR_OTHER||% Subjects with 2-fold increase|18.9||||1|TWO_SIDED|95.0|3.5|34.3||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD3+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD3+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||34.3|3.5|1.000
71072673|NCT00715104|141654726|SUPERIORITY_OR_OTHER||% Subjects with 2-fold increase|70.3|||<|0.001|TWO_SIDED|95.0|52.3|88.3||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD3+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD3+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||88.3|52.3|<0.001
71072674|NCT00715104|141654727|SUPERIORITY_OR_OTHER||% subjects with 2-fold increase|20.6||||1|TWO_SIDED|95.0|4.0|37.2||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD4+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD4+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||37.2|4.0|1.000
71072675|NCT00715104|141654727|SUPERIORITY_OR_OTHER||% subjects with 2-fold increase|32.4||||0.014|TWO_SIDED|95.0|13.1|51.6||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD4+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD4+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||51.6|13.1|0.014
71078704|NCT01215435|141665368|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval for the mean HbA1c treatment difference was below or equal to 0.4%. This is equivalent to using a one-sided test of size 2.5%.|Estimated treatment difference, Mean|-0.14|||<|0.001||95.0|-0.4|0.13|||Regression, Linear|||H0: D \> 0.4% against H1: D ≤ 0.4% where D is the mean treatment difference for change in HbA1c (pre-breakfast OD minus pre-dinner OD)||0.13|-0.40|<0.001
71078705|NCT01215435|141665369|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-3.14||||0.6215||95.0|-15.65|9.37|||Regression, Linear|||||9.37|-15.65|0.6215
70940259|NCT00141271|141380793|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6978||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.6978
70940260|NCT00141271|141380793|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3228||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.3228
70940261|NCT00141271|141380793|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6432||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.6432
70940262|NCT00141271|141380793|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5989||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.5989
70940263|NCT00141271|141380794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8921||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.8921
70940264|NCT00141271|141380794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.435||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.4350
70940265|NCT00141271|141380794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.562||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.5620
70940266|NCT00141271|141380794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6959||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.6959
70940267|NCT00141271|141380794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7865||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.7865
71072676|NCT00715104|141654727|SUPERIORITY_OR_OTHER||% subjects with 2-fold increase|79.4|||<|0.001|TWO_SIDED|95.0|62.8|96.0||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD4+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD4+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||96.0|62.8|<0.001
71072677|NCT00715104|141654728|SUPERIORITY_OR_OTHER||% subjects with 2-fold increase|35.1||||0.002|TWO_SIDED|95.0|16.3|53.9||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD8+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD8+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||53.9|16.3|0.002
71072678|NCT00715104|141654728|SUPERIORITY_OR_OTHER||% subjects with 2-fold increase|29.7||||0.036|TWO_SIDED|95.0|11.7|47.7||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD8+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD8+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||47.7|11.7|0.036
71072679|NCT00715104|141654728|SUPERIORITY_OR_OTHER||% subjects with 2-fold increase|83.8|||<|0.001|TWO_SIDED|95.0|69.3|98.3||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD8+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD8+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||98.3|69.3|<0.001
71072680|NCT00715104|141654729|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P value is for the visit effect in the mixed model|Mixed Models Analysis|Randomization groups, visits (up to 12-weeks Post-RP), and randomization groups × visits interaction were included in the mixed model.||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach. The ranked data were used in the statistical model.||||<0.001
71072681|NCT00715104|141654730|SUPERIORITY_OR_OTHER|||||||0.173|TWO_SIDED|||||P value is for the visit effect in the mixed model|Mixed Models Analysis|Randomization groups, visits (up to 12-weeks Post-RP), and randomization groups × visits interaction were included in the mixed model.||Repeated measure analysis of variance (ANOVA) methods with a mixed model approach was used. The ranked data were used in the statistical model.||||0.173
71114829|NCT01942668|141737424|SUPERIORITY|||||||0.015||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.015
71114830|NCT01942668|141737424|SUPERIORITY|||||||0.1||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||0.100
71114831|NCT01942668|141737425|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||<0.001
71114832|NCT01942668|141737425|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||<0.001
71114833|NCT01942668|141737425|SUPERIORITY|||||||0.009||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||0.009
71114834|NCT01942668|141737425|SUPERIORITY|||||||0.017||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||0.017
71114835|NCT01942668|141737425|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||||||0.001
71114836|NCT01942668|141737425|SUPERIORITY|||||||0.025||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||0.025
71114837|NCT01942668|141737425|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||<0.001
70853392|NCT01185353|141194989|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Physician's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
71114838|NCT01942668|141737425|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||<0.001
71114839|NCT01942668|141737426|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||<0.001
71114840|NCT01942668|141737426|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||<0.001
71114841|NCT01942668|141737426|SUPERIORITY|||||||0.066||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||0.066
71114842|NCT01942668|141737426|SUPERIORITY|||||||0.055||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||0.055
71114843|NCT01942668|141737426|SUPERIORITY|||||||0.174||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||0.174
71114844|NCT01942668|141737426|SUPERIORITY|||||||0.319||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||0.319
71114845|NCT01942668|141737426|SUPERIORITY|||||||0.007||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||0.007
71114846|NCT01942668|141737426|SUPERIORITY|||||||0.008||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||0.008
71114847|NCT01942668|141737427|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||<0.001
71114848|NCT01942668|141737427|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||<0.001
71114849|NCT01942668|141737427|SUPERIORITY|||||||0.019||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||0.019
71114850|NCT01942668|141737427|SUPERIORITY|||||||0.061||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||0.061
71114851|NCT01942668|141737427|SUPERIORITY|||||||0.026||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||0.026
71114852|NCT01942668|141737427|SUPERIORITY|||||||0.104||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||0.104
71114853|NCT01942668|141737427|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||<0.001
70940268|NCT00141271|141380794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7564||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.7564
70940269|NCT00141271|141380795|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4327||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4327
70940270|NCT00141271|141380795|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7041||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7041
70940271|NCT00141271|141380796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2076||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1||||0.2076
70940272|NCT00141271|141380796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7449||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1||||0.7449
70940273|NCT00141271|141380796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4399||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.4399
71114854|NCT01942668|141737427|SUPERIORITY|||||||0.018||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||0.018
71114855|NCT01942668|141737428|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||<0.001
71114856|NCT01942668|141737428|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||<0.001
71114857|NCT01942668|141737428|SUPERIORITY|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||0.006
71114858|NCT01942668|141737428|SUPERIORITY|||||||0.003||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||0.003
70940274|NCT00141271|141380796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7107||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.7107
70940275|NCT00141271|141380796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4765||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.4765
71114859|NCT01942668|141737428|SUPERIORITY|||||||0.017||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||0.017
70853393|NCT01185353|141194989|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Physician's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
71114860|NCT01942668|141737428|SUPERIORITY|||||||0.025||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||0.025
71114861|NCT01942668|141737428|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||0.001
71114862|NCT01942668|141737428|SUPERIORITY|||||||0.037||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||0.037
71114863|NCT01942668|141737429|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||<0.001
71114864|NCT01942668|141737429|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||<0.001
71114865|NCT01942668|141737429|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||0.001
71114866|NCT01942668|141737429|SUPERIORITY|||||||0.016||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||0.016
71114867|NCT01942668|141737429|SUPERIORITY|||||||0.012||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||0.012
70853394|NCT01185353|141194989|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Patient's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
70940276|NCT00141271|141380796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2564||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.2564
70940277|NCT00141271|141380796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8063||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.8063
70853395|NCT01185353|141194989|SUPERIORITY_OR_OTHER|||||||0.072|TWO_SIDED|||||P-value is for Patient's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.072
71114868|NCT01942668|141737429|SUPERIORITY|||||||0.053||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||0.053
71114869|NCT01942668|141737429|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||0.004
71114870|NCT01942668|141737429|SUPERIORITY|||||||0.074||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||0.074
71114871|NCT01942668|141737430|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||<0.001
71114872|NCT01942668|141737430|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||<0.001
71114873|NCT01942668|141737430|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||<0.001
71114874|NCT01942668|141737430|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||<0.001
71114875|NCT01942668|141737430|SUPERIORITY|||||||0.009||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||0.009
71114876|NCT01942668|141737430|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||0.004
71114877|NCT01942668|141737430|SUPERIORITY|||||||0.002||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||0.002
71072682|NCT00715104|141654731|SUPERIORITY_OR_OTHER|||||||0.667|TWO_SIDED|||||P value compares 24 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.||||0.667
71072683|NCT00715104|141654731|SUPERIORITY_OR_OTHER|||||||0.191|TWO_SIDED|||||P value compares 48 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.||||0.191
70940278|NCT00141271|141380796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9855||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.9855
71072684|NCT00715104|141654731|SUPERIORITY_OR_OTHER|||||||0.699|TWO_SIDED|||||P value compares 72 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.||||0.699
71072685|NCT00715104|141654732|SUPERIORITY_OR_OTHER|||||||0.086|TWO_SIDED|||||P value compares 24 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.||||0.086
71114878|NCT01942668|141737430|SUPERIORITY|||||||0.015||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||0.015
71114879|NCT01942668|141737431|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||0.004
71114880|NCT01942668|141737431|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||<0.001
71114881|NCT01942668|141737431|SUPERIORITY|||||||0.002||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||0.002
71114882|NCT01942668|141737431|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||0.001
71114883|NCT01942668|141737431|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||0.001
71114884|NCT01942668|141737431|SUPERIORITY|||||||0.009||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||0.009
71114885|NCT01942668|141737431|SUPERIORITY|||||||0.018||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||0.018
71114886|NCT01942668|141737431|SUPERIORITY|||||||0.021||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||0.021
71114887|NCT01942668|141737432|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
71114888|NCT01942668|141737432|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
71114889|NCT01942668|141737432|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
71114890|NCT01942668|141737432|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
71114891|NCT01942668|141737432|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
71114892|NCT01942668|141737432|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
70853396|NCT01185353|141194989|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Patient's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
70940279|NCT00141271|141380796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0599||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.0599
71072686|NCT00715104|141654732|SUPERIORITY_OR_OTHER|||||||0.432|TWO_SIDED|||||P value compares 48 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.||||0.432
71072687|NCT00715104|141654732|SUPERIORITY_OR_OTHER|||||||0.249|TWO_SIDED|||||P value compares 72 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.||||0.249
71072688|NCT00715104|141654733|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED|||||P value is based on the treatment effect in the mixed model|Mixed Models Analysis|Mixed model includes randomization group, visit, and randomization group × visit interaction, with subject as a random effect.||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach. The ranked data were used in the statistical model.||||0.950
71072689|NCT00715104|141654734|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED|||||P value is based on the treatment effect in the mixed model|Mixed Models Analysis|Mixed model includes randomization group, visit, and randomization group × visit interaction, with subject as a random effect||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach. The ranked data were used in the statistical model.||||0.048
70853397|NCT01185353|141194989|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Patient's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
70940280|NCT00141271|141380796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7364||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.7364
71072690|NCT04599933|141654735|SUPERIORITY||Odds Ratio (OR)|2.916|||<|0.01|TWO_SIDED|95.0|1.663|5.113|||Regression, Logistic|||All treatment comparisons for primary and secondary endpoints related to BDCVA were conducted with a logistic regression model including fixed effects of baseline BDCVA at 40 cm as a covariate and treatment.||5.113|1.663|<0.01
71072691|NCT04599933|141654736|SUPERIORITY||Odds Ratio (OR)|3.035|||<|0.01|TWO_SIDED|95.0|1.736|5.305|||Regression, Logistic|||||5.305|1.736|<0.01
70853398|NCT01185353|141194989|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Patient's Assessment of Pain - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
70853399|NCT01185353|141194989|SUPERIORITY_OR_OTHER|||||||0.082|TWO_SIDED|||||P-value is for Patient's Assessment of Pain - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.082
71072692|NCT04599933|141654737|SUPERIORITY||Odds Ratio (OR)|4.751|||<|0.01|TWO_SIDED|95.0|2.694|8.379|||Regression, Logistic|||||8.379|2.694|<0.01
71072693|NCT04599933|141654738|SUPERIORITY||Odds Ratio (OR)|3.422|||<|0.01|TWO_SIDED|95.0|1.923|6.09|||Regression, Logistic|||||6.090|1.923|<0.01
70940281|NCT00141271|141380796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3048||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups.||Week 6||||0.3048
70940282|NCT00141271|141380796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5139||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups.||Week 6||||0.5139
70940283|NCT00141271|141380796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9356||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.9356
70940284|NCT00141271|141380796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9428||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.9428
71072694|NCT03408444|141654773|SUPERIORITY|Superiority is established if the adjusted upper confidence limit is below 0.|Mean Difference|-0.063|STANDARD_ERROR_OF_MEAN|0.0181|||TWO_SIDED|95.0|-0.106|-0.02|||Mixed Models Analysis|The Kenward and Roger method was used for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 90% power to detect a 0.08 mm difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.||-0.020|-0.106|
71072695|NCT03408444|141654773|SUPERIORITY|Superiority is established if the adjusted upper confidence limit is below 0.|Mean Difference|-0.056|STANDARD_ERROR_OF_MEAN|0.0183|||TWO_SIDED|95.0|-0.1|-0.013|||Mixed Models Analysis|The Kenward and Roger method was used for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 90% power to detect a 0.08 mm difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.||-0.013|-0.100|
71072696|NCT03408444|141654773|SUPERIORITY|Superiority is established if the adjusted upper confidence limit is below 0.|Mean Difference|-0.105|STANDARD_ERROR_OF_MEAN|0.0184|||TWO_SIDED|95.0|-0.149|-0.062|||Mixed Models Analysis|The Kenward and Roger method was used for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 90% power to detect a 0.08 mm difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.||-0.062|-0.149|
71072697|NCT03408444|141654774|SUPERIORITY|Superiority is established if the adjusted lower confidence limit is above 0.|Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.053|||TWO_SIDED|95.0|-0.04|0.21|||Mixed Models Analysis|Kenward and Roger method was for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 79% power to detect a 0.20 D difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.||0.21|-0.04|
71072698|NCT03408444|141654774|SUPERIORITY|Superiority is established if the adjusted lower confidence limit is above 0.|Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|95.0|-0.01|0.25|||Mixed Models Analysis|Kenward and Roger method was used for the denominator degrees of freedom|Mean difference was calculated as Test - Control|It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 79% power to detect a 0.20 D difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.||0.25|-0.01|
71072699|NCT03408444|141654774|SUPERIORITY|Superiority is established if the adjusted lower confidence limit is above 0.|Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|95.0|0.09|0.35|||Mixed Models Analysis|Kenward and Roger method was used for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 79% power to detect a 0.20 D difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.||0.35|0.09|
71072700|NCT01473394|141654776|SUPERIORITY_OR_OTHER||Least square mean difference|-5.117|||<|1e-05|TWO_SIDED|95.0|-6.886|-3.347|||Mixed-effects model for repeated measure|||||-3.347|-6.886|<0.00001
71072701|NCT01473394|141654777|SUPERIORITY_OR_OTHER||Least square mean difference|-0.622|||<|1e-05|TWO_SIDED|95.0|-0.845|-0.399|||Mixed-effects model for repeated measure|||||-0.399|-0.845|<0.00001
71072702|NCT01473394|141654778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.2||||0.0047|TWO_SIDED|95.0|3.0|17.4|||Cochran-Mantel-Haenszel||The Mean Difference (Final Values), as well as the 95% Confidence Interval, are in units of percentage.|||17.4|3.0|0.0047
71072703|NCT01661933|141654811|SUPERIORITY_OR_OTHER|||||||0.693|TWO_SIDED||||||t-test, 2 sided|||||||0.693
71072704|NCT01661933|141654812|SUPERIORITY_OR_OTHER||||||=|0.837|TWO_SIDED||||||t-test, 2 sided|||||||=0.837
71072705|NCT01661933|141654813|SUPERIORITY_OR_OTHER||||||=|0.99|ONE_SIDED||||||Binomial distribution|||The null hypothesis was that irrespective of hookworm infection, GC-1g would result in a 2-point or more deterioration in the Marsh score. A binomial (yes=deterioration or no=no deterioration) distribution was applied to pre- and post-GC-1g paired biopsies.||||=0.99
71072706|NCT01661933|141654814|SUPERIORITY_OR_OTHER||||||=|0.005|TWO_SIDED||||||Mixed effects model.|||||||=0.005
71114893|NCT01942668|141737432|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
70940285|NCT00141271|141380797|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3888||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.3888
71072707|NCT02720744|141654815|SUPERIORITY||Mean Difference (Net)|6.13|||<|0.001|TWO_SIDED|95.0|3.52|8.75||Each outcome measure for the 9.0 g, 7.5 g, and 6.0 g doses were tested at the 2-sided α level of 0.05.|Mixed Models Analysis|P-values were estimated using an MMRM with change from baseline (or its log transformation).|Difference from placebo was defined by the FT218 mean value minus placebo value.|||8.75|3.52|<0.001
70940286|NCT00141271|141380797|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3122||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.3122
70940287|NCT00141271|141380797|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3323||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.3323
70940288|NCT00141271|141380797|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8781||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.8781
71072708|NCT02720744|141654816|SUPERIORITY||Odds Ratio (OR)|5.56|||<|0.001|TWO_SIDED|95.0|2.76|11.23||Each outcome measure for the 9.0 g, 7.5 g, and 6.0 g doses were tested at the 2-sided α level of 0.05.|GLIMMIX model|P-values estimated with categorized CGI-Improvement response (very much or much improved versus other category) at the specific visit.||||11.23|2.76|<0.001
71072709|NCT02720744|141654817|SUPERIORITY||Mean Difference (Net)|-6.65|||<|0.001|TWO_SIDED|95.0|-9.32|-3.98||Each outcome measure for the 9.0 g, 7.5 g, and 6.0 g doses were tested at the 2-sided α level of 0.05.|Mixed Models Analysis|P-values were estimated using an MMRM with change from baseline to the end of the respective treatment period.||||-3.98|-9.32|<0.001
71072710|NCT02901275|141654852|SUPERIORITY|||||||0.61||||||No covariate or correction for multiple comparisons. a priori statistical threshold is p\<.05|Mixed Models Analysis|||||||0.61
71072711|NCT02901275|141654853|SUPERIORITY||||||<|0.0001||||||No covariates or correction for multiple comparisons. a priori threshold is p\<.05.|Mixed Models Analysis|||||||<.0001
71072712|NCT02901275|141654854|SUPERIORITY|||||||0.51||||||No covariate or correction for multiple comparisons. a priori threshold for significance is p\<.05|Mixed Models Analysis|||||||0.51
71072713|NCT02063178|141654855|SUPERIORITY||Mean Difference (Final Values)|2.1|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This randomized clinical trial was designed to have 90% power to detect a 4% weight loss percent difference at 12 months between the two study arms.||||<0.001
71072714|NCT02063178|141654856|OTHER|Correlation|||||<|0.0001|||||||Correlation|||The association between weight change percent and attendance was described using Spearman rank correlation.||||<0.0001
71072715|NCT02063178|141654857|OTHER||||||<|0.0001|||||||Correlation|||||||<0.0001
71072716|NCT02063178|141654858|OTHER||||||<|0.0001|||||||Correlation|||||||<0.0001
71072717|NCT01892085|141654867|SUPERIORITY|||||||0.015|||||||Marginalized two part model|||||||0.015
71072718|NCT01892085|141654867|SUPERIORITY|||||||0.339|||||||Marginalized two part model|||||||0.339
71072719|NCT01892085|141654868|SUPERIORITY|||||||0.024|||||||Marginalized two part model|||||||0.024
71072720|NCT01892085|141654868|SUPERIORITY|||||||0.317|||||||Marginalized two part model|||||||0.317
71072721|NCT01892085|141654869|SUPERIORITY|||||||0.031|||||||Marginalized two part model|||||||0.031
71072722|NCT01892085|141654869|SUPERIORITY|||||||0.298|||||||Marginalized two part model|||||||0.298
71072723|NCT01892085|141654870|SUPERIORITY|||||||0.05|||||||Marginalized two part model|||||||0.05
71072724|NCT01892085|141654870|SUPERIORITY|||||||0.27|||||||Marginalized 2 part model|||||||0.27
71072725|NCT01892085|141654871|SUPERIORITY|||||||0.069|||||||Marginalized two part model|||||||0.069
71072726|NCT01892085|141654871|SUPERIORITY|||||||0.244|||||||Marginalized two part model|||||||0.244
71072727|NCT01892085|141654872|SUPERIORITY|||||||0.094|||||||Marginalized two part model|||||||0.094
71072728|NCT01892085|141654872|SUPERIORITY|||||||0.235|||||||Marginalized 2 part model|||||||0.235
71072729|NCT01892085|141654873|SUPERIORITY|||||||0.123|||||||Marginalized two part model|||||||0.123
71072730|NCT01892085|141654873|SUPERIORITY|||||||0.21|||||||Marginalized two part model|||||||0.210
71072731|NCT01892085|141654874|SUPERIORITY|||||||0.143|||||||Marginalized two part model|||||||0.143
71072732|NCT01892085|141654874|SUPERIORITY|||||||0.196|||||||Marginalized two part model|||||||0.196
71072733|NCT01892085|141654875|SUPERIORITY|||||||0.185|||||||Marginalized two part model|||||||0.185
71072734|NCT01892085|141654875|SUPERIORITY|||||||0.183|||||||Marginalized two part model|||||||0.183
71072735|NCT01892085|141654876|SUPERIORITY|||||||0.229|||||||Marginalized two part model|||||||0.229
71072736|NCT01892085|141654876|SUPERIORITY|||||||0.17|||||||Marginalized two part model|||||||0.170
71072737|NCT01892085|141654877|SUPERIORITY|||||||0.314|||||||Marginalized two part model|||||||0.314
71072738|NCT01892085|141654877|SUPERIORITY|||||||0.162|||||||Marginalized two part model|||||||0.162
71072739|NCT01892085|141654878|SUPERIORITY|||||||0.377|||||||Marginalized two part model|||||||0.377
71072740|NCT01892085|141654878|SUPERIORITY|||||||0.149|||||||Marginalized two part model|||||||0.149
71072741|NCT01892085|141654879|SUPERIORITY|||||||0.08|||||||ANOVA|||||||0.08
71072742|NCT01892085|141654880|SUPERIORITY|||||||0.82|||||||ANOVA|||||||0.82
71072743|NCT01892085|141654881|SUPERIORITY|||||||0.22|||||||Chi-squared|||||||00.22
71072744|NCT01892085|141654882|SUPERIORITY|||||||0.87|||||||Chi-squared|||||||0.87
71072745|NCT01892085|141654883|SUPERIORITY|||||||0.27|||||||Chi-squared|||||||0.27
71072746|NCT01892085|141654884|SUPERIORITY|||||||0.77|||||||Chi-squared|||||||0.77
71072747|NCT01892085|141654885|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||0.31
71072748|NCT01892085|141654886|SUPERIORITY|||||||0.9|||||||Chi-squared|||||||0.90
71072749|NCT01892085|141654887|SUPERIORITY|||||||0.36|||||||Chi-squared|||||||0.36
71072750|NCT00426660|141654935|SUPERIORITY_OR_OTHER||75th percentile (median)|169.0|||||TWO_SIDED|95.0|135.0|178.0||||||||178.0|135.0|
71114894|NCT01942668|141737432|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
71114895|NCT01942668|141737433|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||<0.001
71114896|NCT01942668|141737433|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||<0.001
71114897|NCT01942668|141737433|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||<0.001
71114898|NCT01942668|141737433|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||<0.001
71114899|NCT01942668|141737433|SUPERIORITY|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||0.006
71114900|NCT01942668|141737433|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||0.001
71114901|NCT01942668|141737433|SUPERIORITY|||||||0.015||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||0.015
70853400|NCT01185353|141194989|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Patient's Assessment of Pain - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
71114902|NCT01942668|141737433|SUPERIORITY|||||||0.005||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||0.005
71114903|NCT01942668|141737434|SUPERIORITY|||||||0.523||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.523
71114904|NCT01942668|141737434|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||1.000
71114905|NCT01942668|141737434|SUPERIORITY|||||||0.821||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.821
71114906|NCT01942668|141737434|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||1.000
71114907|NCT01942668|141737434|SUPERIORITY|||||||0.828||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.828
71114908|NCT01942668|141737434|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||1.000
71114909|NCT01942668|141737434|SUPERIORITY|||||||0.239||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.239
71114910|NCT01942668|141737434|SUPERIORITY|||||||0.377||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||0.377
71114911|NCT01942668|141737435|SUPERIORITY|||||||0.036||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.036
71114912|NCT01942668|141737435|SUPERIORITY|||||||0.015||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.015
71114913|NCT01942668|141737435|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||1.000
71114914|NCT01942668|141737435|SUPERIORITY|||||||0.546||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.546
71114915|NCT01942668|141737435|SUPERIORITY|||||||0.352||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.352
70853401|NCT01185353|141194989|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Patient's Assessment of Pain - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
70853402|NCT01185353|141194991|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.024
71114916|NCT01942668|141737435|SUPERIORITY|||||||0.261||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.261
71114917|NCT01942668|141737435|SUPERIORITY|||||||0.058||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.058
71114918|NCT01942668|141737435|SUPERIORITY|||||||0.011||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.011
71114919|NCT01942668|141737436|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||<0.001
71114920|NCT01942668|141737436|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||<0.001
71114921|NCT01942668|141737436|SUPERIORITY|||||||0.115||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.115
71114922|NCT01942668|141737436|SUPERIORITY|||||||0.11||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||0.110
71114923|NCT01942668|141737436|SUPERIORITY|||||||0.089||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.089
71114924|NCT01942668|141737436|SUPERIORITY|||||||0.074||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||0.074
71114925|NCT01942668|141737436|SUPERIORITY|||||||0.011||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.011
71114926|NCT01942668|141737436|SUPERIORITY|||||||0.008||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||0.008
71114927|NCT01942668|141737437|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||<0.001
71114928|NCT01942668|141737437|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||<0.001
70940289|NCT00141271|141380797|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9485||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.9485
70940290|NCT00141271|141380797|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7331||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.7331
71114929|NCT01942668|141737437|SUPERIORITY|||||||0.011||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||0.011
71114930|NCT01942668|141737437|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||<0.001
71114931|NCT01942668|141737437|SUPERIORITY|||||||0.002||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||0.002
71114932|NCT01942668|141737437|SUPERIORITY|||||||0.002||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||0.002
71114933|NCT01942668|141737437|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||<0.001
71114934|NCT01942668|141737437|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||<0.001
71114935|NCT01942668|141737438|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||<0.001
71114936|NCT01942668|141737438|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||<0.001
71114937|NCT01942668|141737438|SUPERIORITY|||||||0.048||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||0.048
71114938|NCT01942668|141737438|SUPERIORITY|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||0.006
71114939|NCT01942668|141737438|SUPERIORITY|||||||0.063||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||0.063
71114940|NCT01942668|141737438|SUPERIORITY|||||||0.058||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||0.058
71114941|NCT01942668|141737438|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||0.004
71114942|NCT01942668|141737438|SUPERIORITY|||||||0.003||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||0.003
70940291|NCT00141271|141380798|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4869||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.4869
71114943|NCT01942668|141737439|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||<0.001
71114944|NCT01942668|141737439|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||<0.001
71114945|NCT01942668|141737439|SUPERIORITY|||||||0.05||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||0.050
71114946|NCT01942668|141737439|SUPERIORITY|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||0.006
71114947|NCT01942668|141737439|SUPERIORITY|||||||0.048||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||0.048
71114948|NCT01942668|141737439|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||0.004
70940292|NCT00141271|141380798|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5813||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.5813
70940293|NCT00141271|141380798|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3303||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.3303
70940294|NCT00141271|141380798|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1546||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.1546
70940295|NCT00141271|141380798|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8982||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.8982
70940296|NCT00141271|141380798|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3586||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.3586
71072751|NCT00426660|141654935|SUPERIORITY_OR_OTHER||50th percentile (median)|86.5|||||TWO_SIDED|95.0|82.0|92.0||||||||92.0|82.0|
71072752|NCT00426660|141654935|SUPERIORITY_OR_OTHER||25th percentile (median)|58.0|||||TWO_SIDED|95.0|57.0|62.0||||||||62.0|57.0|
71072753|NCT01393132|141654941|SUPERIORITY_OR_OTHER|||||||0.0108|TWO_SIDED||||||t-test, 2 sided|||Comparison of fluorescein staining score between the placebo and Thymosin beta 4 groups||||0.0108
70940297|NCT00141271|141380799|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0896||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.0896
71072754|NCT01393132|141654942|SUPERIORITY_OR_OTHER|||||||0.0141|TWO_SIDED||||||t-test, 2 sided|||Comparison of Ocular Discomfort Index score between the placebo and Thymosin beta 4 groups||||0.0141
71072755|NCT01393132|141654943|SUPERIORITY_OR_OTHER|||||||0.0162|TWO_SIDED||||||t-test, 2 sided|||Comparison of Tear Film Break up Time between the placebo and Thymosin beta 4 groups.||||0.0162
71072756|NCT01037127|141654972|SUPERIORITY_OR_OTHER||percentage of participants|25.0|||||TWO_SIDED|95.0|14.1|37.8|||||The estimated value reflects the percentage of particpants with CR and PR.|||37.8|14.1|
70940298|NCT00141271|141380799|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6534||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.6534
70940299|NCT00141271|141380799|SUPERIORITY_OR_OTHER_LEGACY|||||||0.327||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.3270
71072757|NCT01037127|141654973|SUPERIORITY_OR_OTHER||percentage of participants|17.0|||||TWO_SIDED|95.0|2.1|48.4|||||The estimated value reflects the percentage of particpants with CR and PR.|||48.4|2.1|
71072758|NCT01037127|141654973|SUPERIORITY_OR_OTHER||percentage of participants|27.0|||||TWO_SIDED|95.0|14.6|41.9|||||The estimated value reflects the percentage of particpants with CR and PR.|||41.9|14.6|
71072759|NCT01037127|141654973|SUPERIORITY_OR_OTHER||percentage of participants|26.0|||||TWO_SIDED|95.0|14.3|41.4|||||The estimated value reflects the percentage of particpants with CR and PR.|||41.4|14.3|
70940300|NCT00141271|141380799|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4099||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.4099
70940301|NCT00141271|141380799|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6104||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.6104
70940302|NCT00141271|141380799|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9359||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.9359
71072760|NCT01037127|141654973|SUPERIORITY_OR_OTHER||percentage of participants|28.0|||||TWO_SIDED|95.0|14.2|45.2|||||The estimated value reflects the percentage of particpants with CR and PR.|||45.2|14.2|
71072761|NCT01037127|141654974|SUPERIORITY_OR_OTHER||percentage of participants|20.0||||||95.0|7.7|38.6|||||The estimated value reflects the percentage of particpants with CR and PR.|||38.6|7.7|
71072762|NCT02584998|141654984|OTHER||||||<|0.001|||||||Chi-squared|||In our power and sample size analysis, we assumed 15% screening rate in usual care, 25% with invitation, and 40% with mailed-FIT. A sample size of 500 (250/arm) will give 80% power for UC vs. screening invitation-reminder, and 152/arm will give a power of 80% for the screening invitation-reminder vs. mailed-FIT. Accounting for the possibility that up to 20% of participants could be ineligible post-randomization, we concluded that we should enroll 783 patients, 261 per arm, for this trial.||||<0.001
71072763|NCT02847182|141655002|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.83|TWO_SIDED|95.0|-1.58|3.86|||t-test, 2 sided|||Null hypothesis: The mean of the 6-month change in VABS-II Socialization Subscale Standard Score is the same for the Cord Blood and Placebo groups.||3.86|-1.58|0.83
71072764|NCT00778102|141655050|SUPERIORITY_OR_OTHER||Difference in Resection Rate|12.3||||0.2707|TWO_SIDED|95.0|-11.0|35.5|||Chi-squared||Confidence interval calculated for difference based on Hauck-Anderson method.|Difference between groups in the collective percentage of participants with R0, R1, or R2.||35.5|-11.0|0.2707
71072765|NCT00778102|141655053|SUPERIORITY_OR_OTHER||Difference in Response Rate|-4.8||||0.7817|TWO_SIDED|95.0|-43.0|33.5|||Chi-squared||Confidence interval calculated for difference based on Hauck-Anderson method.|Difference between groups in the collective percentage of participants with complete or major histopathological response.||33.5|-43.0|0.7817
71072766|NCT00778102|141655060|SUPERIORITY_OR_OTHER||Difference in Response Rate (CR or PR)|18.9||||0.0612|TWO_SIDED|95.0|-2.1|40.0|||Chi-squared||Confidence interval calculated for difference based on Hauck-Anderson method.|Difference between groups in the collective percentage of participants with confirmed best overall response of CR or PR.||40.0|-2.1|0.0612
70940303|NCT00141271|141380800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6924||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.6924
70940304|NCT00141271|141380800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.0800
71072767|NCT02417961|141655068|SUPERIORITY_OR_OTHER||Percentage|98.2||||||95.0|93.81|99.79|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12)|Percentage of patients who successfully administered benralizumab with an APFS at home (Week 12)|||99.79|93.81|
71072768|NCT02417961|141655068|SUPERIORITY_OR_OTHER||Percentage|99.1|||||TWO_SIDED|95.0|94.99|99.98|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 16)|Percentage of patients who successfully administered benralizumab with an APFS at home (Week 16)|||99.98|94.99|
71072769|NCT02417961|141655068|SUPERIORITY_OR_OTHER||Percentage|93.0|||||TWO_SIDED|95.0|86.64|96.92|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12 and 16)|Percentage of patients who successfully administered benralizumab with an APFS at home (Week 12 and 16)|||96.92|86.64|
71072770|NCT02417961|141655069|SUPERIORITY_OR_OTHER||Percentage|99.1|||||TWO_SIDED|95.0|95.21|99.98|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12)|Percentage of patients returned functional APFS administered at home (Week 12)|||99.98|95.21|
71072771|NCT02417961|141655069|SUPERIORITY_OR_OTHER||Percentage|99.1|||||TWO_SIDED|95.0|94.99|99.98|||Clopper Pearson Exact CI|One sample confidence interval (Week 16)|Percentage of patients returned functional APFS administered at home (Week 16)|||99.98|94.99|
71072772|NCT02417961|141655070|SUPERIORITY_OR_OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|3.13|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 0)|Percentage of mulfunctioning APFS used to administer benralizumab at home or clinic (Week 0)|||3.13|0.00|
71072773|NCT02417961|141655070|SUPERIORITY_OR_OTHER||Percentage|0.9|||||TWO_SIDED|95.0|0.02|4.67|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 4)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 4)|||4.67|0.02|
71072774|NCT02417961|141655070|SUPERIORITY_OR_OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|3.16|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 8)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 8)|||3.16|0.00|
71072775|NCT02417961|141655070|SUPERIORITY_OR_OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|3.13|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 12)|||3.13|0.00|
71072776|NCT02417961|141655070|SUPERIORITY_OR_OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|3.33|||Clopper-Pearson Exact CI|One sample Confidence Interval (Week 16)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 16)|||3.33|0|
71072777|NCT02417961|141655070|SUPERIORITY_OR_OTHER||Percentage|0.3|||||TWO_SIDED|95.0|0.01|1.59|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 0 to 8)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 0 to 8)|||1.59|0.01|
71072778|NCT02417961|141655070|SUPERIORITY_OR_OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|1.63|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12 to 16)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 12 to 16)|||1.63|0.00|
71114949|NCT01942668|141737439|SUPERIORITY|||||||0.02||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||0.020
71114950|NCT01942668|141737439|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||0.001
71114951|NCT01942668|141737440|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||<0.001
71114952|NCT01942668|141737440|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||<0.001
71114953|NCT01942668|141737440|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||0.001
71072779|NCT02417961|141655070|SUPERIORITY_OR_OTHER||Percentage|0.2|||||TWO_SIDED|95.0|0.0|0.97|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 0 to 16)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 0 to 16)|||0.97|0.00|
71114954|NCT01942668|141737440|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||<0.001
71114955|NCT01942668|141737440|SUPERIORITY|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||0.006
71114956|NCT01942668|141737440|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||<0.001
71114957|NCT01942668|141737440|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||<0.001
71114958|NCT01942668|141737440|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||<0.001
71114959|NCT01942668|141737441|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||<0.001
71114960|NCT01942668|141737441|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||<0.001
71114961|NCT01942668|141737441|SUPERIORITY|||||||0.013||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||0.013
71114962|NCT01942668|141737441|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||<0.001
71114963|NCT01942668|141737441|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||0.001
70940305|NCT00141271|141380800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4238||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.4238
71072780|NCT01632904|141655111|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.82||||0.139|TWO_SIDED|95.0|0.82|4.04|||Chi-squared|||||4.04|0.82|0.139
71072781|NCT02059434|141655115|SUPERIORITY_OR_OTHER||Least squares mean difference|0.104|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.06|0.149||All statistical comparisons were two-sided hypothesis tests, and the significance level was set at 0.05 without multiplicity adjustment|ANCOVA|||Change from baseline to trough FEV1 was analyzed by means of an analysis of covariance (ANCOVA) for cross-over designs with sequence, treatment group and period as fixed effect factors, subject within sequence as random effect, and screening and baseline FEV1 value of each period as covariates||0.149|0.060|<0.0001
71114964|NCT01942668|141737441|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||0.004
71114965|NCT01942668|141737441|SUPERIORITY|||||||0.003||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||0.003
71114966|NCT01942668|141737441|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||0.001
71114967|NCT01942668|141737442|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||<0.001
71114968|NCT01942668|141737442|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||<0.001
71114969|NCT01942668|141737442|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||<0.001
71114970|NCT01942668|141737442|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||<0.001
70940306|NCT00141271|141380800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7714||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.7714
71114971|NCT01942668|141737442|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||0.001
71072782|NCT02059434|141655115|SUPERIORITY_OR_OTHER||Least squares mean difference|0.178|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.133|0.223||All statistical comparisons were two-sided hypothesis tests, and the significance level was set at 0.05 without multiplicity adjustment|ANCOVA|||Change from baseline to trough FEV1 was analyzed by means of an analysis of covariance (ANCOVA) for cross-over designs with sequence, treatment group and period as fixed effect factors, subject within sequence as random effect, and screening and baseline FEV1 value of each period as covariates||0.223|0.133|<0.0001
71072783|NCT00771264|141655122|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|Mean values were analyzed for significant change using a 2-sided paired t-test and proportions were analyzed using chi-square methodology.||Mean values were analyzed for significant change using a 2-sided paired t test and proportions were analyzed using chi-square methodology. Median values were analyzed using a Wilcoxon signed rank test with p\<0.05 considered statistically significant. A sample size estimate of 214 subjects, 107 per arm, was calculated using a 2-sided Fisher's exact binomial test based on an estimated 60% responder rate in the PTNS group and a 40% in the sham group with a 5% significance level and 80% power.||||0.05
71072784|NCT02928770|141655127|OTHER|||||||0.0559|||||||t-test, 2 sided|Comparison between baseline and experimental (Nastent) conditions||||||0.0559
71114972|NCT01942668|141737442|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||<0.001
71114973|NCT01942668|141737442|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||0.004
71114974|NCT01942668|141737442|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||<0.001
71114975|NCT01942668|141737443|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||<0.001
71114976|NCT01942668|141737443|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||<0.001
71114977|NCT01942668|141737443|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||<0.001
71114978|NCT01942668|141737443|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||<0.001
71114979|NCT01942668|141737443|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||<0.001
71114980|NCT01942668|141737443|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||<0.001
71072785|NCT01752634|141655159|SUPERIORITY||Odds Ratio (OR)|2.32||||0.02|TWO_SIDED|95.0|1.14|4.73|||Regression, Logistic|||||4.73|1.14|0.0200
71072786|NCT01752634|141655159|SUPERIORITY||Odds Ratio (OR)|6.52|||<|1|TWO_SIDED|95.0|3.25|13.08|||Regression, Logistic|||||13.08|3.25|<0001
70940307|NCT00141271|141380800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8731||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.8731
71072787|NCT01752634|141655159|SUPERIORITY||Odds Ratio (OR)|6.81|||<|0.0001|TWO_SIDED|95.0|3.42|13.56|||Regression, Logistic|||||13.56|3.42|<.0001
71072788|NCT01752634|141655160|SUPERIORITY||Odds Ratio (OR)|2.07||||0.165|TWO_SIDED|95.0|0.74|5.81|||Regression, Logistic|||||5.81|0.74|0.1650
71072789|NCT01752634|141655160|SUPERIORITY||Odds Ratio (OR)|5.7||||0.0006|TWO_SIDED|95.0|2.12|15.34|||Regression, Logistic|||||15.34|2.12|0.0006
71072790|NCT01752634|141655160|SUPERIORITY||Odds Ratio (OR)|9.48|||<|0.0001|TWO_SIDED|95.0|3.33|27.0|||Regression, Logistic|||||27.00|3.33|<.0001
71072791|NCT01752634|141655161|SUPERIORITY||Odds Ratio (OR)|1.38||||0.6421|TWO_SIDED|95.0|0.36|5.36|||Regression, Logistic|||||5.36|0.36|0.6421
71072792|NCT01752634|141655161|SUPERIORITY||Odds Ratio (OR)|6.36||||0.0029|TWO_SIDED|95.0|1.89|21.47|||Regression, Logistic|||||21.47|1.89|0.0029
71072793|NCT01752634|141655161|SUPERIORITY||Odds Ratio (OR)|10.74||||0.0002|TWO_SIDED|95.0|3.13|36.84|||Regression, Logistic|||||36.84|3.13|0.0002
71072794|NCT01752634|141655162|SUPERIORITY||Mean Difference (Net)|-0.16||||0.3763|TWO_SIDED|95.0|-0.53|0.2|||Mixed Models Analysis|||||0.20|-0.53|0.3763
71072795|NCT01752634|141655162|SUPERIORITY||Mean Difference (Net)|-0.62||||0.0008|TWO_SIDED|95.0|-0.98|-0.26|||Mixed Models Analysis|||||-0.26|-0.98|0.0008
71072796|NCT01752634|141655162|SUPERIORITY||Mean Difference (Net)|-0.65||||0.0004|TWO_SIDED|95.0|-1.02|-0.29|||Mixed Models Analysis|||||-0.29|-1.02|0.0004
71072797|NCT01752634|141655163|SUPERIORITY||Mean Difference (Net)|2.42||||0.0482|TWO_SIDED|95.0|0.02|4.83|||Mixed Models Analysis|||||4.83|0.02|0.0482
71072798|NCT01752634|141655163|SUPERIORITY||Mean Difference (Net)|4.44||||0.0003|TWO_SIDED|95.0|2.05|6.83|||Mixed Models Analysis|||||6.83|2.05|0.0003
70940308|NCT00141271|141380800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8926||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.8926
71072799|NCT01752634|141655163|SUPERIORITY||Mean Difference (Net)|5.3|||<|0.0001|TWO_SIDED|95.0|2.91|7.69|||Mixed Models Analysis|||||7.69|2.91|<0.0001
71072800|NCT01752634|141655164|SUPERIORITY||Mean Difference (Net)|-0.01||||0.9195|TWO_SIDED|95.0|-0.16|0.15|||Mixed Models Analysis|||||0.15|-0.16|0.9195
71114981|NCT01942668|141737443|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||0.001
71114982|NCT01942668|141737443|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||<0.001
71114983|NCT01942668|141737444|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
71114984|NCT01942668|141737444|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
71114985|NCT01942668|141737444|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
71114986|NCT01942668|141737444|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
71114987|NCT01942668|141737444|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
71072801|NCT01752634|141655164|SUPERIORITY||Mean Difference (Net)|-0.17||||0.0278|TWO_SIDED|95.0|-0.32|-0.02|||Mixed Models Analysis|||||-0.02|-0.32|0.0278
71072802|NCT01752634|141655164|SUPERIORITY||Mean Difference (Net)|-0.25||||0.0013|TWO_SIDED|95.0|-0.4|-0.1|||Mixed Models Analysis|||||-0.10|-0.40|0.0013
71072803|NCT01752634|141655165|SUPERIORITY||Odds Ratio (OR)|2.91||||0.0245|TWO_SIDED|95.0|1.15|7.36|||Regression, Logistic|||||7.36|1.15|0.0245
71072804|NCT01752634|141655165|SUPERIORITY||Odds Ratio (OR)|7.54|||<|0.0001|TWO_SIDED|95.0|3.11|18.25|||Regression, Logistic|||||18.25|3.11|<.0001
71072805|NCT01752634|141655165|SUPERIORITY||Odds Ratio (OR)|7.15|||<|0.0001|TWO_SIDED|95.0|2.97|17.22|||Regression, Logistic|||||17.22|2.97|<.0001
71114988|NCT01942668|141737444|SUPERIORITY|||||||0.003||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||0.003
71114989|NCT01942668|141737444|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
71114990|NCT01942668|141737444|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
71114991|NCT01942668|141737445|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||<0.001
71114992|NCT01942668|141737445|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||<0.001
70853403|NCT01185353|141194991|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.030
71072806|NCT01752634|141655166|SUPERIORITY||Odds Ratio (OR)|0.51||||0.3149|TWO_SIDED|95.0|0.13|1.91|||Regression, Logistic|||||1.91|0.13|0.3149
71072807|NCT01752634|141655166|SUPERIORITY||Odds Ratio (OR)|0.16||||0.0056|TWO_SIDED|95.0|0.04|0.58|||Regression, Logistic|||||0.58|0.04|0.0056
71072808|NCT01752634|141655166|SUPERIORITY||Odds Ratio (OR)|0.14||||0.0021|TWO_SIDED|95.0|0.04|0.5|||Regression, Logistic|||||0.50|0.04|0.0021
71072809|NCT01752634|141655167|SUPERIORITY||Odds Ratio (OR)|0.58||||0.1678|TWO_SIDED|95.0|0.26|1.26|||Regression, Logistic|||||1.26|0.26|0.1678
71072810|NCT01752634|141655167|SUPERIORITY||Odds Ratio (OR)|0.36||||0.0108|TWO_SIDED|95.0|0.17|0.79|||Regression, Logistic|||||0.79|0.17|0.0108
71072811|NCT01752634|141655167|SUPERIORITY||Odds Ratio (OR)|0.29||||0.0025|TWO_SIDED|95.0|0.13|0.65|||Regression, Logistic|||||0.65|0.13|0.0025
71072812|NCT01196936|141655176|SUPERIORITY|||||||0.05||||||The calculated p-value is 0.05.|Mixed Models Analysis|||||||0.05
71114993|NCT01942668|141737445|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||<0.001
71114994|NCT01942668|141737445|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||<0.001
71072813|NCT01196936|141655177|SUPERIORITY|||||||0.0266|||||||Mixed Models Analysis|||||||0.0266
71072814|NCT01196936|141655178|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
71114995|NCT01942668|141737445|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||<0.001
71114996|NCT01942668|141737445|SUPERIORITY|||||||0.056||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||0.056
71072815|NCT01196936|141655179|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71072816|NCT01196936|141655180|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
71072817|NCT01196936|141655181|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||> 0.05
71072818|NCT01196936|141655182|SUPERIORITY|||||||0.071|||||||Mixed Models Analysis|||||||0.071
71072819|NCT01196936|141655183|SUPERIORITY|||||||0.739|||||||Mixed Models Analysis|||||||0.739
71072820|NCT01196936|141655184|SUPERIORITY|||||||0.8315|||||||Mixed Models Analysis|||||||0.8315
71072821|NCT01911780|141655240|SUPERIORITY_OR_OTHER||Adjusted mean, comparison|-7.5|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|-9.7|-5.3|||LOCF-ANCOVA|Last observation carried forward (LOCF) was used as the imputation method|Model includes baseline DBP as a linear covariate, and treatment and center as fixed effects.|||-5.3|-9.7|<0.0001
71072822|NCT01911780|141655241|SUPERIORITY_OR_OTHER||Adjusted mean, comparison|-8.6|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001|TWO_SIDED|95.0|-12.7|-4.5||Additional information, the p-value is not adjusted for multiplicity.|LOCF-ANCOVA||Model includes baseline SBP as a linear covariate, and treatment and center as fixed effects.|||-4.5|-12.7|<0.0001
71072823|NCT01911780|141655242|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.1||||0.0052|TWO_SIDED|95.0|1.4|7.1||Additional information, the p-value is not adjusted for multiplicity.|Regression, Logistic|Non-completers considered failures (NCF) was used as the imputation method.|Exact 95 % confidence interval by Clopper and Pearson. Logistic regression includes treatment and center.|||7.1|1.4|0.0052
71072824|NCT01911780|141655244|SUPERIORITY_OR_OTHER||Adjusted Mean|-0.4|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|-3.1|2.3|||mixed-effects model repeated measures||As a linear covariate, and treatment and visit, treatment by visit interaction and baseline value by visit interaction as fixed effects.|||2.3|-3.1|
71072825|NCT01911780|141655245|SUPERIORITY_OR_OTHER||Adjusted Mean|2.3|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|95.0|-1.5|6.1|||mixed-effects model repeated measures||Model includes baseline SBP as a linear covariate, and treatment and visit, treatment by visit interaction and baseline value by visit interaction as fixed effects.|||6.1|-1.5|
71072826|NCT05014815|141655253|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.4698|TWO_SIDED|95.0|0.74|1.33||1-sided p-value|Log Rank|Stratified by PD-L1 expression (\<1% of tumor cells (TC) vs 1-49% TC vs \>= 50% TC) and histology (squamous vs non-squamous).|The HR and its 95% confidence interval (CI) was estimated using a Cox regression model stratified by PD-L1 expression (\<1% of tumor cells (TC) vs 1-49% TC vs \>= 50% TC) and histology (squamous vs non-squamous).|||1.33|0.74|0.4698
71072827|NCT05014815|141655254|OTHER||Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.47|1.26|||||The Mantel-Haenszel common OR and its 95% CI were estimated using a normal approximation of the log odds ratio and the Robins-Breslow-Greenland variance, stratified by PD-L1 expression and histology.|||1.26|0.47|
71072828|NCT05014815|141655256|OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.67|1.34|||||The HR and its 95% confidence interval (CI) was estimated using a Cox regression model stratified by PD-L1 expression (\<1% of tumor cells (TC) vs 1-49% TC vs \>= 50% TC) and histology (squamous vs non-squamous).|||1.34|0.67|
71072829|NCT02453282|141655264|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.036|TWO_SIDED|97.54|0.564|1.019||The 2-sided p-value was calculated using a stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.019|0.564|0.036
71072830|NCT02453282|141655264|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.202|TWO_SIDED|98.77|0.611|1.173||The 2-sided p-value was calculated using a stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.173|0.611|0.202
71072831|NCT02453282|141655265|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.705|TWO_SIDED|99.5|0.722|1.534||The analysis was performed using stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.534|0.722|0.705
71072832|NCT02453282|141655266|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.523|TWO_SIDED|95.0|0.836|1.421||The 2-sided p-value was calculated using a stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.421|0.836|0.523
71072833|NCT02453282|141655267|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.194|TWO_SIDED|95.0|0.725|1.067||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.067|0.725|0.194
71078706|NCT05811026|141665371|SUPERIORITY||Median Difference (Net)|5.0||||0.075|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.075
71078707|NCT05811026|141665372|SUPERIORITY||Median Difference (Net)|0.17||||0.4727|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.4727
71078708|NCT05811026|141665373|SUPERIORITY||Median Difference (Net)|-1.5||||0.7326|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.7326
71078709|NCT05811026|141665374|SUPERIORITY||Median Difference (Net)|0.61||||0.0757|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0757
71072834|NCT02453282|141655267|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.952|TWO_SIDED|95.0|0.834|1.213||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.213|0.834|0.952
71072835|NCT02453282|141655267|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.218|TWO_SIDED|95.0|0.931|1.371||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.371|0.931|0.218
71072836|NCT02453282|141655268|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.602|TWO_SIDED|95.0|0.812|1.128||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.128|0.812|0.602
71072837|NCT02453282|141655268|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.43|TWO_SIDED|95.0|0.794|1.103||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.103|0.794|0.430
71072838|NCT02453282|141655268|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.802|TWO_SIDED|95.0|0.828|1.157||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.157|0.828|0.802
71072839|NCT02453282|141655269|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.324|TWO_SIDED|95.0|0.667|1.143||The analysis was performed using stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.143|0.667|0.324
71072840|NCT02453282|141655269|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.207|TWO_SIDED|95.0|0.911|1.541||The analysis was performed using stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.541|0.911|0.207
71072841|NCT02453282|141655270|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.383|TWO_SIDED|95.0|0.894|1.339||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.339|0.894|0.383
71078710|NCT05811026|141665375|SUPERIORITY||Median Difference (Net)|37.75||||0.0376|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0376
71078711|NCT05811026|141665376|SUPERIORITY||Median Difference (Final Values)|-0.17||||0.3123|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.3123
71078712|NCT05811026|141665377|SUPERIORITY||Median Difference (Final Values)|1.0||||0.1009|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.1009
71078713|NCT05811026|141665378|SUPERIORITY||Mean Difference (Net)|5.5||||0.0088|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0088
71078714|NCT05811026|141665379|SUPERIORITY||Median Difference (Net)|-0.03||||0.4274|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.4274
71078715|NCT05811026|141665380|SUPERIORITY||Mean Difference (Net)|1.75||||0.6497|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.6497
71078716|NCT05811026|141665381|SUPERIORITY||Median Difference (Net)|0.54||||0.0006|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0006
71078717|NCT05811026|141665382|SUPERIORITY||Median Difference (Net)|34.5||||0.0002|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0002
71078718|NCT05811026|141665383|SUPERIORITY||Median Difference (Final Values)|0.0||||0.6231|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.6231
71078719|NCT05811026|141665384|SUPERIORITY||Median Difference (Final Values)|0.0||||0.3327|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.3327
71078720|NCT05811026|141665385|SUPERIORITY||Median Difference (Net)|7.25||||0.0752|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0752
71072842|NCT02453282|141655270|SUPERIORITY||Hazard Ratio (HR)|1.38||||0.001|TWO_SIDED|95.0|1.136|1.678||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.678|1.136|0.001
71072843|NCT02453282|141655270|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.138|TWO_SIDED|95.0|0.954|1.403||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.403|0.954|0.138
71072844|NCT02453282|141655271|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.015|TWO_SIDED|95.0|1.043|1.475||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.475|1.043|0.015
71072845|NCT02453282|141655271|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.01|TWO_SIDED|95.0|1.054|1.485||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.485|1.054|0.010
71072846|NCT02453282|141655271|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.984|TWO_SIDED|95.0|0.845|1.179||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.179|0.845|0.984
71072847|NCT02453282|141655272|SUPERIORITY||Odds Ratio (OR)|0.91||||0.698|TWO_SIDED|95.0|0.582|1.437||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.437|0.582|0.698
71072848|NCT02453282|141655272|SUPERIORITY||Odds Ratio (OR)|0.87||||0.534|TWO_SIDED|95.0|0.549|1.363||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.363|0.549|0.534
71078721|NCT05811026|141665386|SUPERIORITY||Median Difference (Net)|-0.94||||0.0982|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0982
71078722|NCT05811026|141665387|SUPERIORITY||Median Difference (Net)|-0.5||||0.8541|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.8541
71078723|NCT05811026|141665388|SUPERIORITY||Median Difference (Net)|0.63||||0.0758|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0758
71078724|NCT05811026|141665389|SUPERIORITY||Median Difference (Net)|41.75||||0.066|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.066
71078725|NCT05811026|141665390|SUPERIORITY||Median Difference (Final Values)|-0.17||||0.6961|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.6961
71078726|NCT05811026|141665391|SUPERIORITY||Median Difference (Final Values)|1.0||||0.0067|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0067
71078727|NCT02870205|141665393|SUPERIORITY||||||<|0.001||||||GSP 301 NS vs GSP 301 placebo NS comparison for rTNSS was tested at 0.05 significance level.|ANCOVA|||||||<0.001
71078728|NCT02870205|141665393|SUPERIORITY|||||||0.028|||||||ANCOVA|||||||0.028
71078729|NCT02870205|141665393|SUPERIORITY|||||||0.019|||||||ANCOVA|||||||0.019
71078730|NCT02870205|141665393|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
71078731|NCT02870205|141665393|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
71078732|NCT01249833|141665410|SUPERIORITY_OR_OTHER||LS Means Difference|-30.4||||0.0492|TWO_SIDED|95.0|-60.7|-0.1|||ANCOVA||The LS means for Standard of Care Alone was subtracted from that of Oseltamivir.|||-0.1|-60.7|.0492
71078733|NCT01249833|141665411|SUPERIORITY_OR_OTHER||LS Means Difference|3.8||||0.0054|TWO_SIDED|95.0|1.14|6.42|||ANCOVA||The LS means for Standard of Care Alone was subtracted from that of Oseltamivir.|||6.42|1.14|0.0054
71078734|NCT01249833|141665412|SUPERIORITY_OR_OTHER||LS Means Difference|3.9||||0.9685|TWO_SIDED|95.0|-190.1|197.9|||ANCOVA||The LS means for Standard of Care Alone was subtracted from that of Oseltamivir.|||197.9|-190.1|.9685
71078735|NCT01249833|141665413|SUPERIORITY_OR_OTHER||LS Means Difference|1.9||||0.3195|TWO_SIDED|95.0|-1.9|5.7|||ANCOVA||The LS means for Standard of Care Alone was subtracted from that of Oseltamivir.|Alertness: the higher the value, the greater the alertness.||5.7|-1.9|.3195
71072849|NCT02453282|141655272|SUPERIORITY||Odds Ratio (OR)|0.95||||0.82|TWO_SIDED|95.0|0.601|1.496||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.496|0.601|0.820
71072850|NCT02453282|141655273|SUPERIORITY||Odds Ratio (OR)|0.69||||0.05|TWO_SIDED|95.0|0.48|1.0||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non squamous) and PD-L1 status (\>=25% Vs \<25%), with 95% CI calculated by profile likelihood.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.000|0.480|0.050
71072851|NCT02453282|141655273|SUPERIORITY||Odds Ratio (OR)|0.67||||0.029|TWO_SIDED|95.0|0.464|0.959||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non squamous) and PD-L1 status (\>=25% Vs \<25%), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||0.959|0.464|0.029
71072852|NCT02453282|141655273|SUPERIORITY||Odds Ratio (OR)|0.97||||0.887|TWO_SIDED|95.0|0.661|1.43||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non squamous) and PD-L1 status (\>=25% Vs \<25%), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.430|0.661|0.887
71072853|NCT02453282|141655274|SUPERIORITY||Odds Ratio (OR)|0.65||||0.012|TWO_SIDED|95.0|0.462|0.908||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non squamous) and PD-L1 status (\>=25% Vs \<25%), with 95% CI calculated by profile likelihood.|Durvalumab Monotherapy Vs SoC Chemotherapy||0.908|0.462|0.012
71072854|NCT02453282|141655274|SUPERIORITY||Odds Ratio (OR)|0.76||||0.093|TWO_SIDED|95.0|0.543|1.048||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non-squamous) and PD-L1 status (\>=25% Vs \<25%), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.048|0.543|0.093
71072855|NCT02453282|141655274|SUPERIORITY||Odds Ratio (OR)|1.16||||0.406|TWO_SIDED|95.0|0.818|1.647||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non-squamous) and PD-L1 status (\>=25% Vs \<25%), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.647|0.818|0.406
70853404|NCT01185353|141194991|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
71072856|NCT02453282|141655281|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.03|TWO_SIDED|95.0|0.597|0.975||The 2-sided p-value was calculated using a stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||0.975|0.597|0.030
71072857|NCT02453282|141655281|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.045|TWO_SIDED|95.0|0.606|0.994||The 2-sided p-value was calculated using a stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||0.994|0.606|0.045
71072858|NCT02453282|141655282|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.255|TWO_SIDED|95.0|0.746|1.08||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.080|0.746|0.255
70853405|NCT01185353|141194991|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
70853406|NCT01185353|141194993|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED|||||P-value is for comparison of the superiority of the LY3009104 dose level vs. placebo for the ordinal levels of response - Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Cochran-Mantel-Haenszel|||||||0.120
71072859|NCT02453282|141655282|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.534|TWO_SIDED|95.0|0.787|1.132||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.132|0.787|0.534
71078736|NCT01249833|141665413|SUPERIORITY_OR_OTHER||LS Means Difference|-0.6||||0.7219|TWO_SIDED|95.0|-4.1|2.9|||ANCOVA||The LS means for Standard of Care AL one was subtracted from that of Oseltamivir.|Calmness: the higher the value, the greater the calmness.||2.9|-4.1|.7219
71072860|NCT02453282|141655283|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.663|TWO_SIDED|95.0|0.824|1.131||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.131|0.824|0.663
71072861|NCT02453282|141655283|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.103|TWO_SIDED|95.0|0.746|1.027||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.027|0.746|0.103
71072862|NCT01629823|141655321|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81||||0.51|TWO_SIDED|95.0|0.44|1.5||Comparison of 5cm group to control. No adjustment for multiple comparisons.|Regression, Linear|||Both the 5 and 10cm groups were compared to the control group, \<1cm H₂O||1.50|0.44|0.51
71072863|NCT01629823|141655321|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84||||0.57|TWO_SIDED|95.0|0.47|1.52|||Regression, Linear|||||1.52|0.47|0.57
71072864|NCT00480493|141655322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.46|STANDARD_ERROR_OF_MEAN|3.36||0.468|TWO_SIDED|95.0|-4.32|9.24|||t-test, 2 sided||Confidence scores were also compared using random-effect, mixed regression models to determine whether changes over time differed significantly between groups.|A 2 sided t-test was used to determine if the change in Confidence score was significantly different between the groups.||9.24|-4.32|0.468
71072865|NCT00480493|141655323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.82|STANDARD_ERROR_OF_MEAN|10.05||0.634|TWO_SIDED|95.0|-15.47|25.11|||t-test, 2 sided||Concern scores were also compared using random-effect, mixed regression models to determine whether changes over time differed significantly between groups.|A 2 sided t-test was used to determine if there were significant differences in Concern between the two groups at 12 months.||25.11|-15.47|0.634
71072866|NCT00480493|141655324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.48|STANDARD_ERROR_OF_MEAN|3.12||0.43|TWO_SIDED|95.0|-8.76|3.8|||t-test, 2 sided||We also used a random-effect, mixed regression models to look for between group changes over time.|The difference in the Worry score at 12 months was compared between the groups using a 2 sided t-test.||3.80|-8.76|0.430
71072867|NCT00738062|141655325|SUPERIORITY_OR_OTHER|||||||0.438|||||||Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at randomization.||||||0.438
71114997|NCT01942668|141737445|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||<0.001
71114998|NCT01942668|141737445|SUPERIORITY|||||||0.017||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||0.017
71072868|NCT00738062|141655326|SUPERIORITY_OR_OTHER|||||||0.554|||||||Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHDAS Composite value at randomization.||||||0.554
71072869|NCT00738062|141655327|SUPERIORITY_OR_OTHER|||||||0.198|||||||Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Composite value at baseline.||||||0.198
71072870|NCT00738062|141655328|SUPERIORITY_OR_OTHER|||||||0.286|||||||Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at randomization.||||||0.286
71072871|NCT00738062|141655329|SUPERIORITY_OR_OTHER|||||||0.251|||||||Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at randomization.||||||0.251
71072872|NCT00738062|141655330|SUPERIORITY_OR_OTHER|||||||0.708|||||||Fisher Exact|||||||0.708
71072873|NCT00738062|141655331|SUPERIORITY_OR_OTHER|||||||0.873|||||||Fisher Exact|||||||0.873
71072874|NCT00738062|141655332|SUPERIORITY_OR_OTHER|||||||0.252|||||||Fisher Exact|||||||0.252
71072875|NCT00738062|141655333|SUPERIORITY_OR_OTHER|||||||0.33|||||||Fisher Exact|||||||0.330
71114999|NCT01942668|141737446|SUPERIORITY||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||||||<0.001
71115000|NCT01942668|141737446|SUPERIORITY|||||||0.005||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||||||0.005
71115001|NCT01942668|141737446|SUPERIORITY|||||||0.007||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||||||0.007
71072876|NCT00550862|141655334|OTHER||||||<|0.0001||||||Initial Phase 2 study: no a priori estimate of treatment effect available. Effect size estimated.|Wilcoxon (Mann-Whitney)|Hierarchical model applied and pairwise comparisons of the 10mg treatment group versus the placebo group, then 25 mg and 50 mg were performed.||All tests: Descriptive methods were used with nominal p values provided and 95% confidence intervals.||||<0.0001
71072877|NCT00550862|141655334|OTHER||||||<|0.0001||||||Initial Phase 2 study: no a priori estimate of treatment effect available. Effect size estimated.|Wilcoxon (Mann-Whitney)|Hierarchical model applied and pairwise comparisons of the 10mg treatment group versus the placebo group, then 25 mg and 50 mg were performed.||All tests: Descriptive methods were used with nominal p values provided and 95% confidence intervals.||||<0.0001
71072878|NCT00550862|141655334|OTHER||||||<|0.0001||||||Initial Phase 2 study: no a priori estimate of treatment effect available. Effect size estimated.|Wilcoxon (Mann-Whitney)|Hierarchical model applied and pairwise comparisons of the 10mg treatment group versus the placebo group, then 25 mg and 50 mg were performed.||All tests: Descriptive methods were used with nominal p values provided and 95% confidence intervals||||<0.0001
71072879|NCT00550862|141655335|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71072880|NCT00550862|141655336|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0005||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0005
71072881|NCT00980174|141655371|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.8|||<|0.0001|TWO_SIDED|95.0|4.0|5.6|||ANCOVA|Adjusted by level of baseline bone mineral density T-score|Denosumab - Placebo|||5.6|4.0|<0.0001
71115002|NCT01942668|141737446|SUPERIORITY|||||||0.004||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||||||0.004
71072882|NCT00980174|141655372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|||<|0.0001|TWO_SIDED|95.0|1.5|2.6||p-value is adjusted for multiple comparisons by Hochberg method|ANCOVA|Adjusted by level of baseline bone mineral density T-score|Denosumab - Placebo|||2.6|1.5|<0.0001
71072883|NCT00980174|141655373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2|||<|0.0001|TWO_SIDED|95.0|1.3|3.0||p-value is adjusted for multiple comparisons by Hochberg method|ANCOVA|Adjusted by level of baseline bone mineral density T-score|Denosumab - Placebo|||3.0|1.3|<0.0001
71072884|NCT00980174|141655374|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.3|||<|0.0001|TWO_SIDED|95.0|1.4|3.2||p-value is adjusted for multiple comparisons by Hochberg method|ANCOVA|Adjusted by level of baseline bone mineral density T-score|Denosumab - Placebo|||3.2|1.4|<0.0001
71072885|NCT00980174|141655375|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.9||||0.0144|TWO_SIDED|95.0|0.2|1.6||p-value is adjusted for multiple comparisons by Hochberg method|ANCOVA|Adjusted by level of baseline bone mineral density T-score|Denosumab - Placebo|||1.6|0.2|0.0144
71072886|NCT00980174|141655376|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value is adjusted for multiple comparisons by Hochberg method|Van Elteren Rank Test|Adjusted by level of baseline bone mineral density T-score||||||<0.0001
71072887|NCT01683422|141655380|SUPERIORITY|The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.||||||0.1|||||||t-test, 1 sided|||In the RTOG 9812 (NCT00003591) for unresectable pancreatic cancer, a one-year survival rate of 43% was observed. There were 109 analyzable patients on NCT00003591 with 61 still at risk for death at one year. Using the method of Dixon and Simon, a sample size of 39 analyzable patients followed over 12 months will ensure at least 90% probability of detecting a minimum of 17% improvement in the one-year survival rate compared to NCT00003591 at the 0.10 significance level (with a one-sided test).||||0.1
71072888|NCT02003963|141655384|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
71072889|NCT01260272|141655458|SUPERIORITY_OR_OTHER||||||=|0.033||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||=0.033
71072890|NCT01260272|141655459|SUPERIORITY_OR_OTHER||||||=|0.0468||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||=0.0468
71072891|NCT01260272|141655460|SUPERIORITY_OR_OTHER||||||=|0.2114||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||=0.2114
71072892|NCT01260272|141655461|SUPERIORITY_OR_OTHER||||||=|0.1727||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||=0.1727
71072893|NCT01260272|141655462|SUPERIORITY_OR_OTHER||||||=|0.7498||||||Apriori threshold for statistical significance was \<=0.05|Wilcoxon (Mann-Whitney)|||||||=0.7498
71072894|NCT01260272|141655463|SUPERIORITY_OR_OTHER||||||=|0.2615||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||=0.2615
71115003|NCT01942668|141737448|SUPERIORITY||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||||||<0.001
71115004|NCT01942668|141737448|SUPERIORITY||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||||||<0.001
71115005|NCT01942668|141737448|SUPERIORITY|||||||0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||||||0.001
71115006|NCT01942668|141737448|SUPERIORITY|||||||0.002||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||||||0.002
71115007|NCT01942668|141737450|SUPERIORITY||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||||||<0.001
71115008|NCT01942668|141737450|SUPERIORITY||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||||||<0.001
71115009|NCT01942668|141737450|SUPERIORITY||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||||||<0.001
71115010|NCT01942668|141737450|SUPERIORITY|||||||0.002||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||||||0.002
71115011|NCT01942668|141737452|SUPERIORITY|||||||0|||||||Fisher Exact|||||||0.000
71115012|NCT01942668|141737452|SUPERIORITY|||||||0.122|||||||Fisher Exact|||||||0.122
71115013|NCT01942668|141737452|SUPERIORITY|||||||0.28|||||||Fisher Exact|||||||0.280
71115014|NCT01942668|141737452|SUPERIORITY|||||||0.692|||||||Fisher Exact|||||||0.692
71072895|NCT01260272|141655464|SUPERIORITY_OR_OTHER||||||=|0.6915||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||=0.6915
71072896|NCT01260272|141655465|SUPERIORITY_OR_OTHER|||||||0.106||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||0.1060
71072897|NCT03589326|141655468|SUPERIORITY||Risk Difference (RD)|0.18|||=|0.0021|TWO_SIDED|95.0|0.06|0.29||P-value is based on CMH chi-square test, with stratification according to randomization strata (age): 18 through \<45 years, ≥45 through \<60 years, and ≥60 years.|Chi-squared||Risk difference and 95% CI: adjusted percent ponatinib - adjusted percent imatinib and its 95% CI.|||0.29|0.06|=0.0021
71072898|NCT00435487|141655482|NON_INFERIORITY_OR_EQUIVALENCE|The test of non-inferiority was based on whether the upper limit of the two-sided 95% confidence interval for the treatment group difference was less than or equal to 10%, the non-inferiority margin specified in the protocol.|Difference in proportion|-2.6||||||95.0|-8.59|3.4|||upper limit of 95% CI <= 10%||95% confidence interval (CI) is for difference in proportion using normal approximation to binomial. Non-inferiority was concluded if the upper boundary of the 95% CI for the Dalteparin - Unfractioned Heparin difference was less than or equal to 10%.|Death after receiving 48 hours of study medication (Event date - First dose date) and on or before day 30 from baseline. Difference in proportion (Dalteparin-UFH)(%).||3.40|-8.59|
71072899|NCT00435487|141655482|NON_INFERIORITY_OR_EQUIVALENCE|The test of non-inferiority was based on whether the upper limit of the two-sided 95% confidence interval for the treatment group difference was less than or equal to 10%, the non-inferiority margin specified in the protocol.|Difference in proportion|1.25||||||95.0|-3.02|5.52|||upper limit of 95% CI <= 10%||95% CI is for difference in proportion using normal approximation to binomial. Non-inferiority was concluded if the upper boundary of the 95% CI for the Dalteparin - Unfractioned Heparin difference was less than or equal to 10%.|Non-fatal Myocardial Infarction after receiving 48 hours of study medication (Event date - First dose date) and on or before day 30 from baseline. Difference in proportion (Dalteparin-UFH)(%).||5.52|-3.02|
71072900|NCT00435487|141655482|NON_INFERIORITY_OR_EQUIVALENCE|The test of non-inferiority was based on whether the upper limit of the two-sided 95% confidence interval for the treatment group difference was less than or equal to 10%, the non-inferiority margin specified in the protocol.|Difference in proportion|-1.35||||||95.0|-8.62|5.93|||upper limit of 95% CI <= 10%||95% CI is for difference in proportion using normal approximation to binomial. Non-inferiority was concluded if the upper boundary of the 95% CI for the Dalteparin - Unfractioned Heparin difference was less than or equal to 10%.|Death or Non-fatal Myocardial Infarction after receiving 48 hours of study medication (Event date - First dose date) and on or before day 30 from baseline. Difference in proportion (Dalteparin-UFH)(%).||5.93|-8.62|
71072901|NCT00435487|141655483|SUPERIORITY_OR_OTHER||Difference in proportion|1.27||||1||95.0|-1.2|3.73|||Chi-squared||95% CI is for difference in proportion using normal approximation to binomial.|Difference in proportion (Dalteparin-UFH)(%).||3.73|-1.20|1.0000
71072902|NCT00435487|141655484|SUPERIORITY_OR_OTHER||Difference in proportion|-0.05||||1||95.0|-6.05|5.95|||Chi-squared||95% CI is for difference in proportion using normal approximation to binomial.|Difference in proportion (Dalteparin-UFH)(%).||5.95|-6.05|1.0000
71072903|NCT00435487|141655485|SUPERIORITY_OR_OTHER||Difference in proportion|-0.05||||1||95.0|-6.05|5.95|||Chi-squared||95% CI is for difference in proportion using normal approximation to binomial.|Difference in proportion (Dalteparin-UFH)(%).||5.95|-6.05|1.0000
71072904|NCT03301844|141655490|SUPERIORITY|||||||0.071|||||||Chi-squared||||"Patient preference for one of the two treatments at Visit 3 was presented overall in terms of number and percentage of patients preferring the standard or the study treatment.~Patient preference was compared between the standard and the study treatment with a Chi-Square test for equal proportion."|||0.071
71072905|NCT03301844|141655491|OTHER|||||||0.7353|||||||Chi-squared||||"The incidence of all the treatment-emergent systemic Adverse Events recorded in the eCRF was presented overall at patient level; the incidence of all the treatment-emergent ocular Adverse Events recorded in eCRF was presented by treatment group at eye level.~Incidence of treatment-emergent ocular Adverse Events was compared between treatment groups by means of a Chi-square test."|||0.7353
71072906|NCT00501059|141655496|SUPERIORITY_OR_OTHER|||||||0.597|||||||Log Rank|||Primary efficacy analysis of time to the composite endpoint was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant and the primary objective of the study will have been met if the 2-sided P value is ≤0.05.||||0.597
71072907|NCT00501059|141655497|SUPERIORITY_OR_OTHER|||||||0.6125|||||||Log Rank|||Statistics for time to the composite endpoint was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.6125
71072908|NCT00501059|141655498|SUPERIORITY_OR_OTHER|||||||0.4505|||||||Log Rank|||Statistics for time to non-fatal MI was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.4505
71072909|NCT00501059|141655498|SUPERIORITY_OR_OTHER|||||||0.229|||||||Log Rank|||Statistics for time to total MI was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.229
71078737|NCT01249833|141665413|SUPERIORITY_OR_OTHER||LS Means Difference|3.3||||0.1162|TWO_SIDED|95.0|-0.8|7.4|||ANCOVA||The LS means of Standard of Care Alone was subtracted from that of Oseltamivir.|Contentedness: the higher the value, the greater the contentedness.||7.4|-.8|.1162
70853407|NCT01185353|141194993|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||P-value is for comparison of the superiority of the LY3009104 dose level vs. placebo for the ordinal levels of response - Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Cochran-Mantel-Haenszel|||||||0.012
71072910|NCT00501059|141655498|SUPERIORITY_OR_OTHER|||||||0.3947|||||||Log Rank|||Statistics for time to total non-fatal stroke was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.3947
71072911|NCT00501059|141655498|SUPERIORITY_OR_OTHER|||||||0.5125|||||||Log Rank|||Statistics for time to total stroke was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.5125
71072912|NCT00501059|141655499|SUPERIORITY_OR_OTHER|||||||0.9544|||||||Log Rank|||Analysis of time to all-cause mortality was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.9544
71072913|NCT00501059|141655499|SUPERIORITY_OR_OTHER|||||||0.4422|||||||Log Rank|||Analysis of time to the first occurrence of all cancers excluding non-melanoma skin cancer was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.4422
71072914|NCT00501059|141655499|SUPERIORITY_OR_OTHER|||||||0.611|||||||Log Rank|||Analysis of time to the first occurence colon cancer was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.611
71072915|NCT00501059|141655500|OTHER||Cox Proportional Hazard|0.99||||0.9459|TWO_SIDED|95.0|0.8|1.24|||Log Rank|||Analysis of incidence of all-cause mortality was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.24|0.80|0.9459
71072916|NCT00501059|141655501|OTHER||Cox Proportional Hazard|0.85||||0.2325|TWO_SIDED|95.0|0.64|1.11|||Log Rank|||Analysis of incidence of MI was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.11|0.64|0.2325
71072917|NCT00501059|141655501|OTHER||Cox Proportional Hazard|1.12||||0.5072||95.0|0.8|1.55|||Log Rank|||Analysis of incidence of stroke was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.55|0.80|0.5072
71072918|NCT00501059|141655501|OTHER||Cox Proportional Hazard|0.97||||0.901||95.0|0.62|1.52|||Log Rank|||Analysis of incidence of cardiovascular death was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.52|0.62|0.9010
71072919|NCT00501059|141655501|OTHER||Cox Proportional Hazard|1.0||||0.9979|TWO_SIDED|95.0|0.54|1.86|||Log Rank|||Analysis of incidence of UA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.86|0.54|0.9979
71072920|NCT00501059|141655501|OTHER||Cox Proportional Hazard|0.93||||0.7455|TWO_SIDED|95.0|0.61|1.42|||Log Rank|||Analysis of incidence of TIA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.42|0.61|0.7455
71072921|NCT00501059|141655503|OTHER||Cox Proportional Hazard|0.96||||0.6038|TWO_SIDED|95.0|0.81|1.13|||Log Rank|||Analysis of incidence of composite outcome of MI, stroke, CV death, UA or TIA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.13|0.81|0.6038
71072922|NCT00501059|141655503|OTHER||Cox Proportional Hazard|0.95||||0.619|TWO_SIDED|95.0|0.79|1.15|||Log Rank|||Analysis of incidence of composite outcome of MI, stroke or CV death was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.15|0.79|0.6190
71072923|NCT00501059|141655503|OTHER||Cox Proportional Hazard|0.9||||0.4562|TWO_SIDED|95.0|0.67|1.2|||Log Rank|||Analysis of incidence of non-fatal MI was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.20|0.67|0.4562
71072924|NCT00501059|141655504|OTHER||Cox Proportional Hazard|0.81||||0.0756|TWO_SIDED|95.0|0.64|1.02|||Log Rank|||Analysis of incidence of composite outcome of MI, stroke, CV death, UA or TIA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.02|0.64|0.0756
71072925|NCT00501059|141655504|OTHER||Cox Proportional Hazard|0.79||||0.0661|TWO_SIDED|95.0|0.61|1.02|||Log Rank|||Analysis of incidence of composite outcome of MI, stroke or CV death was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.02|0.61|0.0661
71072926|NCT00501059|141655504|OTHER||Cox Proportional Hazard|0.53||||0.0014|TWO_SIDED|95.0|0.36|0.79|||Log Rank|||Analysis of incidence of MI was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||0.79|0.36|0.0014
71072927|NCT00501059|141655504|OTHER||Cox Proportional Hazard|0.55||||0.0056|TWO_SIDED|95.0|0.36|0.84|||Log Rank|||Analysis of incidence of non-fatal MI was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||0.84|0.36|0.0056
71072928|NCT00501059|141655504|OTHER||Cox Proportional Hazard|1.12||||0.6291||95.0|0.71|1.75|||Log Rank|||Analysis of incidence of stroke was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.75|0.71|0.6291
71115015|NCT01942668|141737453|SUPERIORITY|||||||0|||||||Fisher Exact|||||||0.000
71115016|NCT01942668|141737453|SUPERIORITY|||||||0.069|||||||Fisher Exact|||||||0.069
71115017|NCT01942668|141737453|SUPERIORITY|||||||0.131|||||||Fisher Exact|||||||0.131
71115018|NCT01942668|141737453|SUPERIORITY|||||||0.661|||||||Fisher Exact|||||||0.661
71115019|NCT01942668|141737454|SUPERIORITY|||||||0|||||||Fisher Exact|||||||0.000
71115020|NCT01942668|141737454|SUPERIORITY|||||||0.04|||||||Fisher Exact|||||||0.040
71115021|NCT01942668|141737454|SUPERIORITY|||||||0.082|||||||Fisher Exact|||||||0.082
71115022|NCT01942668|141737454|SUPERIORITY|||||||0.495|||||||Fisher Exact|||||||0.495
71115023|NCT01942668|141737455|SUPERIORITY|||||||0|||||||Fisher Exact|||||||0.000
71115024|NCT01942668|141737455|SUPERIORITY|||||||0.032|||||||Fisher Exact|||||||0.032
71115025|NCT01942668|141737455|SUPERIORITY|||||||0.137|||||||Fisher Exact|||||||0.137
71115026|NCT01942668|141737455|SUPERIORITY|||||||0.792|||||||Fisher Exact|||||||0.792
71072929|NCT00501059|141655504|OTHER||Cox Proportional Hazard|1.03||||0.9161|TWO_SIDED|95.0|0.6|1.77|||Log Rank|||Analysis of incidence of CV death was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.77|0.60|0.9161
71072930|NCT00501059|141655504|OTHER||Cox Proportional Hazard|0.75||||0.538||95.0|0.3|1.87|||Log Rank|||Analysis of incidence of UA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.87|0.30|0.5380
71072931|NCT00501059|141655504|OTHER||Cox Proportional Hazard|1.03||||0.9181|TWO_SIDED|95.0|0.55|1.95|||Log Rank|||Analysis of incidence of TIA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.95|0.55|0.9181
71072932|NCT00501059|141655504|OTHER||Cox Proportional Hazard|1.1||||0.4796|TWO_SIDED|95.0|0.84|1.45|||Log Rank|||Analysis of incidence of all-cause mortality was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.45|0.84|0.4796
71072933|NCT03559868|141655509|SUPERIORITY||||||<|0.01|||||||ANOVA|Ordinary one-way ANOVA Bartlett's test||For IL10||||<0.01
71072934|NCT01785849|141655523|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|32.46|||<|0.001|TWO_SIDED|95.0|18.71|56.31|||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel test stratified by screening PTH category (\< 600, ≥ 600 to ≤ 1000, and \> 1000 pg/mL), recent cinacalcet use within 8 weeks before randomization (yes and no), and region (North America and non-North America) was used to compare the primary endpoint of proportion of participants with \> 30% reduction from baseline in PTH during the EAP between etelcalcetide and placebo.||56.31|18.71|<0.001
71072935|NCT01785849|141655524|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|22.08|||<|0.001|TWO_SIDED|95.0|11.47|42.48|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by screening PTH category, recent cinacalcet use within 8 weeks before randomization, and region.||||42.48|11.47|<0.001
71072936|NCT01785849|141655525|SUPERIORITY_OR_OTHER||Mean Difference|-71.11|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-77.77|-64.46|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-64.46|-77.77|<0.001
71072937|NCT01785849|141655526|SUPERIORITY_OR_OTHER||Mean Difference|-8.38|STANDARD_ERROR_OF_MEAN|0.58|<|0.001|TWO_SIDED|95.0|-9.52|-7.23|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-7.23|-9.52|<0.001
71072938|NCT01785849|141655527|SUPERIORITY_OR_OTHER||Mean Difference|-14.99|STANDARD_ERROR_OF_MEAN|2.41|<|0.001|TWO_SIDED|95.0|-19.73|-10.25|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-10.25|-19.73|<0.001
71072939|NCT01785849|141655528|SUPERIORITY_OR_OTHER||Mean Difference|-7.45|STANDARD_ERROR_OF_MEAN|2.47||0.003|TWO_SIDED|95.0|-12.31|-2.59|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-2.59|-12.31|0.003
71072940|NCT03315455|141655555|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.016|0.084||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm A vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.084|0.016|<0.0001
71072941|NCT03315455|141655555|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.015|0.082||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm B vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.082|0.015|<0.0001
71072942|NCT03315455|141655558|SUPERIORITY||ABR Ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.026|0.084||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm A vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.084|0.026|<0.0001
71072943|NCT03315455|141655558|SUPERIORITY||ABR Ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.028|0.092||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm B vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.092|0.028|<0.0001
71072944|NCT03315455|141655561|SUPERIORITY||ABR Ratio|0.02|||<|0.0001|TWO_SIDED|95.0|0.006|0.053||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm A vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.053|0.006|<0.0001
70853408|NCT01185353|141194993|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for comparison of the superiority of the LY3009104 dose level vs. placebo for the ordinal levels of response - Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Cochran-Mantel-Haenszel|||||||<0.001
70853409|NCT01185353|141194993|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for comparison of the superiority of the LY3009104 dose level vs. placebo for the ordinal levels of response - Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Cochran-Mantel-Haenszel|||||||<0.001
70853410|NCT01185353|141194995|SUPERIORITY_OR_OTHER|||||||0.409|TWO_SIDED|||||P-value is for Low Disease Activity - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||0.409
71115027|NCT01942668|141737456|SUPERIORITY|||||||0|||||||Fisher Exact|||||||0.000
71115028|NCT01942668|141737456|SUPERIORITY|||||||0.067|||||||Fisher Exact|||||||0.067
71115029|NCT01942668|141737456|SUPERIORITY|||||||0.26|||||||Fisher Exact|||||||0.260
71115030|NCT01942668|141737456|SUPERIORITY|||||||0.792|||||||Fisher Exact|||||||0.792
71115031|NCT01942668|141737457|SUPERIORITY|||||||0.001|||||||Fisher Exact|||||||0.001
71115032|NCT01942668|141737457|SUPERIORITY|||||||0.095|||||||Fisher Exact|||||||0.095
71115033|NCT01942668|141737457|SUPERIORITY|||||||0.352|||||||Fisher Exact|||||||0.352
71115034|NCT01942668|141737457|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71115035|NCT01942668|141737458|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
71115036|NCT01942668|141737458|SUPERIORITY|||||||0.075|||||||Fisher Exact|||||||0.075
71115037|NCT01942668|141737458|SUPERIORITY|||||||0.225|||||||Fisher Exact|||||||0.225
71115038|NCT01942668|141737458|SUPERIORITY|||||||0.769|||||||Fisher Exact|||||||0.769
71115039|NCT01942668|141737459|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
71115040|NCT01942668|141737459|SUPERIORITY|||||||0.084|||||||Fisher Exact|||||||0.084
71115041|NCT01942668|141737459|SUPERIORITY|||||||0.183|||||||Fisher Exact|||||||0.183
71115042|NCT01942668|141737459|SUPERIORITY|||||||0.738|||||||Fisher Exact|||||||0.738
71115043|NCT01942668|141737460|SUPERIORITY|||||||0.006|||||||Fisher Exact|||||||0.006
71115044|NCT01942668|141737460|SUPERIORITY|||||||0.125|||||||Fisher Exact|||||||0.125
71115045|NCT01942668|141737460|SUPERIORITY|||||||0.386|||||||Fisher Exact|||||||0.386
71115046|NCT01942668|141737460|SUPERIORITY|||||||0.737|||||||Fisher Exact|||||||0.737
71115047|NCT01942668|141737461|SUPERIORITY|||||||0.009|||||||Fisher Exact|||||||0.009
71115048|NCT01942668|141737461|SUPERIORITY|||||||0.183|||||||Fisher Exact|||||||0.183
71115049|NCT01942668|141737461|SUPERIORITY|||||||0.745|||||||Fisher Exact|||||||0.745
71115050|NCT01942668|141737461|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71115051|NCT01942668|141737462|SUPERIORITY|||||||0.035|||||||Fisher Exact|||||||0.035
71115052|NCT01942668|141737462|SUPERIORITY|||||||0.536|||||||Fisher Exact|||||||0.536
71115053|NCT01942668|141737462|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71115054|NCT01942668|141737462|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71115055|NCT01942668|141737463|SUPERIORITY|||||||0.261|||||||Fisher Exact|||||||0.261
71115056|NCT01942668|141737463|SUPERIORITY|||||||0.536|||||||Fisher Exact|||||||0.536
71115057|NCT01942668|141737463|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71115058|NCT01942668|141737463|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71115059|NCT01942668|141737464|SUPERIORITY|||||||0.463|||||||Fisher Exact|||||||0.463
71115060|NCT01942668|141737464|SUPERIORITY|||||||0.687|||||||Fisher Exact|||||||0.687
71115061|NCT01942668|141737464|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71115062|NCT01942668|141737464|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71115063|NCT01942668|141737465|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71115064|NCT01942668|141737465|SUPERIORITY|||||||0.048|||||||Fisher Exact|||||||0.048
71115065|NCT01942668|141737465|SUPERIORITY|||||||0.049|||||||Fisher Exact|||||||0.049
71115066|NCT01942668|141737465|SUPERIORITY|||||||0.328|||||||Fisher Exact|||||||0.328
71115067|NCT01942668|141737466|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71115068|NCT01942668|141737466|SUPERIORITY|||||||0.123|||||||Fisher Exact|||||||0.123
71115069|NCT01942668|141737466|SUPERIORITY|||||||0.03|||||||Fisher Exact|||||||0.030
71115070|NCT01942668|141737466|SUPERIORITY|||||||0.649|||||||Fisher Exact|||||||0.649
71115071|NCT01942668|141737467|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71115072|NCT01942668|141737467|SUPERIORITY|||||||0.059|||||||Fisher Exact|||||||0.059
71115073|NCT01942668|141737467|SUPERIORITY|||||||0.023|||||||Fisher Exact|||||||0.023
71115074|NCT01942668|141737467|SUPERIORITY|||||||0.426|||||||Fisher Exact|||||||0.426
71115075|NCT01942668|141737468|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71115076|NCT01942668|141737468|SUPERIORITY|||||||0.044|||||||Fisher Exact|||||||0.044
71115077|NCT01942668|141737468|SUPERIORITY|||||||0.011|||||||Fisher Exact|||||||0.011
71115078|NCT01942668|141737468|SUPERIORITY|||||||0.481|||||||Fisher Exact|||||||0.481
71115079|NCT01942668|141737469|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71115080|NCT01942668|141737469|SUPERIORITY|||||||0.11|||||||Fisher Exact|||||||0.110
71115081|NCT01942668|141737469|SUPERIORITY|||||||0.045|||||||Fisher Exact|||||||0.045
71115082|NCT01942668|141737469|SUPERIORITY|||||||0.853|||||||Fisher Exact|||||||0.853
71115083|NCT01942668|141737470|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71115084|NCT01942668|141737470|SUPERIORITY|||||||0.245|||||||Fisher Exact|||||||0.245
71115085|NCT01942668|141737470|SUPERIORITY|||||||0.145|||||||Fisher Exact|||||||0.145
71115086|NCT01942668|141737470|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71115087|NCT01942668|141737471|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71115088|NCT01942668|141737471|SUPERIORITY|||||||0.163|||||||Fisher Exact|||||||0.163
71072945|NCT03315455|141655561|SUPERIORITY||ABR Ratio|0.02|||<|0.0001|TWO_SIDED|95.0|0.007|0.059||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm B vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.059|0.007|<0.0001
71072946|NCT03315455|141655564|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.017|0.102||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm A vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.102|0.017|<0.0001
71072947|NCT03315455|141655564|SUPERIORITY||ABR Ratio|0.03|||<|0.0001|TWO_SIDED|95.0|0.013|0.084||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm B vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.084|0.013|<0.0001
71072948|NCT03315455|141655567|SUPERIORITY||ABR Ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.016|0.163||Not controlled for Type I error|Stratified Wald test||The ABR ratio was calculated as Arm A vs. Arm C.|||0.163|0.016|<0.0001
71072949|NCT03315455|141655567|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.011|0.122||Not controlled for Type I error|ABR Ratio||The ABR ratio was calculated as Arm B vs. Arm C.|||0.122|0.011|<0.0001
71072950|NCT03315455|141655572|SUPERIORITY||Difference in Adjusted Means|14.68||||0.0515|TWO_SIDED|95.0|-0.1|29.46||Type I error controlled|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm A.|||29.46|-0.10|0.0515
71115089|NCT01942668|141737471|SUPERIORITY|||||||0.091|||||||Fisher Exact|||||||0.091
71072951|NCT03315455|141655572|SUPERIORITY||Difference in Adjusted Means|18.33||||0.0204|TWO_SIDED|95.0|2.97|33.68||Type I error controlled|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm B.|||33.68|2.97|0.0204
71072952|NCT03315455|141655574|SUPERIORITY||Difference in Adjusted Means|6.06||||0.3281|TWO_SIDED|95.0|-6.27|18.4||Not controlled for Type I error|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm A.|||18.40|-6.27|0.3281
71072953|NCT03315455|141655574|SUPERIORITY||Difference in Adjusted Means|14.01||||0.0297|TWO_SIDED|95.0|1.44|26.59||Not controlled for Type I error|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm B.|||26.59|1.44|0.0297
71072954|NCT03315455|141655577|SUPERIORITY||Difference in Adjusted Means|-3.46||||0.6165|TWO_SIDED|95.0|-17.23|10.31||Not controlled for Type I error|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm A.|||10.31|-17.23|0.6165
71072955|NCT03315455|141655577|SUPERIORITY||Difference in Adjusted Means|-7.58||||0.2797|TWO_SIDED|95.0|-21.48|6.33||Not controlled for Type I error|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm B.|||6.33|-21.48|0.2797
71072956|NCT03315455|141655579|SUPERIORITY||Difference in Adjusted Means|-0.05||||0.489|TWO_SIDED|95.0|-0.18|0.09||Not controlled for Type I error|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm A.|||0.09|-0.18|0.4890
71072957|NCT03315455|141655579|SUPERIORITY||Difference in Adjusted Means|-0.08||||0.2454|TWO_SIDED|95.0|-0.22|0.06||Not controlled for Type I error|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm B.|||0.06|-0.22|0.2454
71072958|NCT03030118|141655605|SUPERIORITY|||||||0.72|||||||Regression, Logistic|||For the primary outcome (SLICC classification criteria count \[SLICC score\]), measured every 12 weeks over a 96-week period, we used an ordinal logistic regression model to compare the estimated slopes over time for the intervention (HCQ) and placebo groups. The model accounted for the ordinal and non-decreasing properties of the SLICC score. Our null hypothesis was that the intervention slope equaled the placebo slope, with a corresponding hypothesis that the slopes were not equal.||||0.72
71072959|NCT03030118|141655606|SUPERIORITY|||||||0.81|||||||Regression, Cox|||Progression to SLE was defined as the number of subjects in whom a SLICC score of 4 was recorded, up to 96 weeks.||||0.81
71072960|NCT03030118|141655607|SUPERIORITY|||||||0.74|||||||Regression, Logistic|||"For the SLEDAI score, we combined responses to model the following groups:~* Score of 0 or 1~* Score of 2 or 3~* Score of 4, 6, or 8"||||0.74
71072961|NCT03030118|141655608|SUPERIORITY|||||||0.77|||||||Regression, Logistic|Ordinal logistic regression||"For analysis, we combined responses ≥3 to model the following groups:~* Score of 0~* Score of 1~* Score of 2~* Score of 3 or higher"||||0.77
71072962|NCT03030118|141655609|SUPERIORITY|||||||0.386|||||||t-test, 2 sided|Paired t-test||||||0.386
71115090|NCT01942668|141737471|SUPERIORITY|||||||0.693|||||||Fisher Exact|||||||0.693
71115091|NCT01942668|141737472|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71115092|NCT01942668|141737472|SUPERIORITY|||||||0.178|||||||Fisher Exact|||||||0.178
71115093|NCT01942668|141737472|SUPERIORITY|||||||0.097|||||||Fisher Exact|||||||0.097
71115094|NCT01942668|141737472|SUPERIORITY|||||||0.522|||||||Fisher Exact|||||||0.522
71115095|NCT01942668|141737473|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71115096|NCT01942668|141737473|SUPERIORITY|||||||0.315|||||||Fisher Exact|||||||0.315
71115097|NCT01942668|141737473|SUPERIORITY|||||||0.181|||||||Fisher Exact|||||||0.181
71115098|NCT01942668|141737473|SUPERIORITY|||||||0.821|||||||Fisher Exact|||||||0.821
71115099|NCT01942668|141737474|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71115100|NCT01942668|141737474|SUPERIORITY|||||||0.387|||||||Fisher Exact|||||||0.387
71115101|NCT01942668|141737474|SUPERIORITY|||||||0.215|||||||Fisher Exact|||||||0.215
71115102|NCT01942668|141737474|SUPERIORITY|||||||0.639|||||||Fisher Exact|||||||0.639
71115103|NCT01942668|141737475|SUPERIORITY|||||||0.008|||||||Fisher Exact|||||||0.008
71115104|NCT01942668|141737475|SUPERIORITY|||||||0.643|||||||Fisher Exact|||||||0.643
71072963|NCT03030118|141655610|SUPERIORITY|||||||0.497|||||||t-test, 2 sided|Paired t-test||||||0.497
71072964|NCT03030118|141655611|SUPERIORITY|||||||0.99|||||||Regression, Logistic|Ordinal logistic regression||||||0.99
71072965|NCT03030118|141655612|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71072966|NCT03030118|141655613|NON_INFERIORITY|Outcome with hydroxychloroquine is hypothesized to be not inferior to outcome with placebo.|||||>|0.5|||||||Fisher Exact|||||||>0.5
71072967|NCT03030118|141655614|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71115105|NCT01942668|141737475|SUPERIORITY|||||||0.501|||||||Fisher Exact|||||||0.501
70940309|NCT00141271|141380800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2072||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.2072
71072968|NCT03030118|141655615|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71072969|NCT01032070|141655616|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22||95.0||||P-value is not adjusted for multiple comparisons.|Fisher Exact|||The study was not powered for this comparison due to small sample size.||||0.2200
71072970|NCT01541839|141655632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|327.0|STANDARD_DEVIATION|70.0|<|0.0001|TWO_SIDED|95.0|||||t-test, 1 sided||The mean time for closure with septal stapler was 35 +/-22 seconds versus 7 minutes +/- 1 minute 10 seconds for suture closure. The mean net difference between groups was 327 seconds, or 6 minutes 27 seconds.|The operative time required for closure and NOSE questionnaire scores were analyzed with unpaired and paired t-tests respectively. Chi-squared testing was used for post-operative complication rates. The mean closure time for septoplasty was estimated to be 10 minutes +/- 4 minutes. It was assumed that the septal stapler would take 5 minutes +/- 4 minutes. Assuming a one-sided test, an alpha of 0.05 and a power of 0.8, a total of 16 patients were needed.||||<0.0001
71072971|NCT00551161|141655686|SUPERIORITY_OR_OTHER||||||<|0.05||||||Due to the exploratory nature of these analyses, no adjustment for multiple testing was made. Although it would have been preferable to carry out an omnibus analysis, due to the small sample size, the descriptive approach described above was used.|Wilcoxon (Mann-Whitney)|||The Wilcoxon signed-rank test was used to examine whether the change between t0 and t1 differed from the change between t1 and t2 \[(t2 - t1) - (t1 - t0)\] for each of the metabolites and ratios, in order to examine whether the rate of change differed while on monotherapy as compared with combination therapy.||||<0.05
71072972|NCT00231283|141655692|SUPERIORITY_OR_OTHER||Percentage of participants|97.0|STANDARD_ERROR_OF_MEAN|1.71||||95.0|91.5|99.4|||Qualitative Comparison|Reported in qualitative/semi-quantitative comparitive fashion due to study design.||||99.4|91.5|
70940310|NCT00141271|141380800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1042||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.1042
71072973|NCT00231283|141655693|SUPERIORITY_OR_OTHER||Percentage of participants|3.0||||||95.0|0.6|8.6|||No formal statistical testing|||||8.6|0.6|
71072974|NCT00231283|141655694|SUPERIORITY_OR_OTHER||Percentage of participants|3.0||||||95.0|0.6|8.5|||Descriptive statistics|||||8.5|0.6|
71072975|NCT00231283|141655695|SUPERIORITY_OR_OTHER||Percentage of participants|10.4||||||95.0|5.1|18.3|||Descriptive statistics|||||18.3|5.1|
71072976|NCT00772005|141655696|SUPERIORITY_OR_OTHER|||||||0.8514||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8514
71072977|NCT00772005|141655696|SUPERIORITY_OR_OTHER|||||||0.6995||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6995
71072978|NCT00772005|141655696|SUPERIORITY_OR_OTHER|||||||0.9766||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9766
71072979|NCT00772005|141655697|SUPERIORITY_OR_OTHER|||||||0.7596||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7596
71078738|NCT03796676|141665414|SUPERIORITY||Estimate of difference|16.7||||0.0147|TWO_SIDED|95.0|3.5|29.9|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 100 mg minus placebo|||29.9|3.5|0.0147
71078739|NCT03796676|141665414|SUPERIORITY||Estimate of difference|20.6||||0.003|TWO_SIDED|95.0|7.3|33.9|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 200 mg minus placebo|||33.9|7.3|0.0030
71078740|NCT03796676|141665415|SUPERIORITY||Estimate of difference|26.5||||0.0002|TWO_SIDED|95.0|13.1|39.8|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 100 mg minus placebo|||39.8|13.1|0.0002
71078741|NCT03796676|141665415|SUPERIORITY||Estimate of difference|29.4|||<|0.0001|TWO_SIDED|95.0|16.3|42.5|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 200 mg minus placebo|||42.5|16.3|<0.0001
71078742|NCT03796676|141665416|SUPERIORITY||Estimate of difference|14.7||||0.0119||95.0|3.5|25.9|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 2 was calculated by PF-04965842 100 mg minus placebo|||25.9|3.5|0.0119
71078743|NCT03796676|141665416|SUPERIORITY||Estimate of difference|26.1|||<|0.0001|TWO_SIDED|95.0|13.9|38.3|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 2 was calculated by PF-04965842 200 mg minus placebo|||38.3|13.9|<0.0001
71078744|NCT03796676|141665416|SUPERIORITY||Estimate of difference|10.9||||0.0971|TWO_SIDED|95.0|-1.8|23.6|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 4 was calculated by PF-04965842 100 mg minus placebo|||23.6|-1.8|0.0971
71078745|NCT03796676|141665416|SUPERIORITY||Estimate of difference|29.4|||<|0.0001|TWO_SIDED|95.0|16.0|42.9|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 4 was calculated by PF-04965842 200 mg minus placebo|||42.9|16.0|<0.0001
70853411|NCT01185353|141194995|SUPERIORITY_OR_OTHER|||||||0.371|TWO_SIDED|||||P-value is for Low Disease Activity - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||0.371
70853412|NCT01185353|141194995|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Low Disease Activity - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||<0.001
71115106|NCT01942668|141737475|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71115107|NCT01942668|141737476|SUPERIORITY|||||||0.013|||||||Fisher Exact|||||||0.013
71115108|NCT01942668|141737476|SUPERIORITY|||||||0.616|||||||Fisher Exact|||||||0.616
71115109|NCT01942668|141737476|SUPERIORITY|||||||0.352|||||||Fisher Exact|||||||0.352
71115110|NCT01942668|141737476|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71115111|NCT01942668|141737477|SUPERIORITY|||||||0.023|||||||Fisher Exact|||||||0.023
71115112|NCT01942668|141737477|SUPERIORITY|||||||0.535|||||||Fisher Exact|||||||0.535
71115113|NCT01942668|141737477|SUPERIORITY|||||||0.183|||||||Fisher Exact|||||||0.183
71115114|NCT01942668|141737477|SUPERIORITY|||||||0.738|||||||Fisher Exact|||||||0.738
71115115|NCT01942668|141737478|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 1|Fisher Exact|||||||<0.001
71115116|NCT01942668|141737478|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 1|Fisher Exact|||||||0.004
71115117|NCT01942668|141737478|SUPERIORITY|||||||0.012||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 1|Fisher Exact|||||||0.012
71115118|NCT01942668|141737478|SUPERIORITY|||||||0.032||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 1|Fisher Exact|||||||0.032
71115119|NCT01942668|141737479|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 2|Fisher Exact|||||||<0.001
71115120|NCT01942668|141737479|SUPERIORITY|||||||0.022||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 2|Fisher Exact|||||||0.022
71115121|NCT01942668|141737479|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 2|Fisher Exact|||||||0.004
71115122|NCT01942668|141737479|SUPERIORITY|||||||0.256||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 2|Fisher Exact|||||||0.256
71115123|NCT01942668|141737480|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 3|Fisher Exact|||||||<0.001
71115124|NCT01942668|141737480|SUPERIORITY|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 3|Fisher Exact|||||||0.006
71115125|NCT01942668|141737480|SUPERIORITY|||||||0.025||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 3|Fisher Exact|||||||0.025
71115126|NCT01942668|141737480|SUPERIORITY|||||||0.182||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 3|Fisher Exact|||||||0.182
71115127|NCT01942668|141737481|SUPERIORITY|||||||0.002||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 4|Fisher Exact|||||||0.002
71115128|NCT01942668|141737481|SUPERIORITY|||||||0.469||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 4|Fisher Exact|||||||0.469
71115129|NCT01942668|141737481|SUPERIORITY|||||||0.188||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 4|Fisher Exact|||||||0.188
71115130|NCT01942668|141737481|SUPERIORITY|||||||0.613||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 4|Fisher Exact|||||||0.613
71115131|NCT01942668|141737486|SUPERIORITY|||||||0.002||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 1|Fisher Exact|||||||0.002
71115132|NCT01942668|141737486|SUPERIORITY|||||||0.135||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 1|Fisher Exact|||||||0.135
71115133|NCT01942668|141737486|SUPERIORITY|||||||0.26||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 1|Fisher Exact|||||||0.260
71115134|NCT01942668|141737486|SUPERIORITY|||||||0.257||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 1|Fisher Exact|||||||0.257
71115135|NCT01942668|141737487|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 2|Fisher Exact|||||||<0.001
71115136|NCT01942668|141737487|SUPERIORITY|||||||0.085||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 2|Fisher Exact|||||||0.085
71115137|NCT01942668|141737487|SUPERIORITY|||||||0.184||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 2|Fisher Exact|||||||0.184
71115138|NCT01942668|141737487|SUPERIORITY|||||||0.681||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 2|Fisher Exact|||||||0.681
71115139|NCT01942668|141737488|SUPERIORITY|||||||0.008||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 3|Fisher Exact|||||||0.008
71115140|NCT01942668|141737488|SUPERIORITY|||||||0.036||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 3|Fisher Exact|||||||0.036
71072980|NCT00772005|141655697|SUPERIORITY_OR_OTHER|||||||0.562||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5620
71072981|NCT00772005|141655697|SUPERIORITY_OR_OTHER|||||||0.6688||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6688
71072982|NCT00772005|141655698|SUPERIORITY_OR_OTHER|||||||0.1894||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1894
71072983|NCT00772005|141655698|SUPERIORITY_OR_OTHER|||||||0.4582||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4582
71072984|NCT00772005|141655698|SUPERIORITY_OR_OTHER|||||||0.0327||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0327
71072985|NCT00772005|141655699|SUPERIORITY_OR_OTHER|||||||0.3275||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3275
71072986|NCT00772005|141655699|SUPERIORITY_OR_OTHER|||||||0.2597||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2597
71072987|NCT00772005|141655699|SUPERIORITY_OR_OTHER|||||||0.0039||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0039
71072988|NCT00772005|141655700|SUPERIORITY_OR_OTHER|||||||0.0713||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0713
71072989|NCT00772005|141655700|SUPERIORITY_OR_OTHER|||||||0.0431||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0431
71072990|NCT00772005|141655700|SUPERIORITY_OR_OTHER|||||||0.0063||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0063
71078746|NCT03796676|141665416|SUPERIORITY||Estimate of difference|22.8||||0.0035|TWO_SIDED|95.0|8.0|37.7|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 100 mg minus placebo|||37.7|8.0|0.0035
71078747|NCT03796676|141665416|SUPERIORITY||Estimate of difference|25.6||||0.0013|TWO_SIDED|95.0|10.6|40.6|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 200 mg minus placebo|||40.6|10.6|0.0013
71078748|NCT03796676|141665417|SUPERIORITY||Mean Difference (Net)|-0.5||||0.0664|TWO_SIDED|95.0|-1.1|0.0|||Mixed Models Analysis||The least squares mean difference at Week 12 was calculated by PF-04965842 100 mg minus placebo|||0.0|-1.1|0.0664
71078749|NCT03796676|141665417|SUPERIORITY||Mean Difference (Net)|-0.7||||0.0142|TWO_SIDED|95.0|-1.3|-0.1|||Mixed Models Analysis||The least squares mean difference at Week 12 was calculated by PF-04965842 200 mg minus placebo|||-0.1|-1.3|0.0142
71078750|NCT02432144|141665460|SUPERIORITY||LS Mean|-62.28|STANDARD_ERROR_OF_MEAN|4.946|<|0.0001|TWO_SIDED|95.0|-71.98|-52.59||P-values are from generalized estimating equation (GEE) model including baseline value and visit (in this study) as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||Week 0||-52.59|-71.98|< 0.0001
71078751|NCT02432144|141665460|SUPERIORITY||LS Mean|-67.18|STANDARD_ERROR_OF_MEAN|3.224|<|0.0001|TWO_SIDED|95.0|-73.49|-60.86||P-values are from a GEE model including baseline value and visit (in this study) as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||Week 12||-60.86|-73.49|< 0.0001
71078752|NCT02432144|141665460|SUPERIORITY||LS Mean|-64.12|STANDARD_ERROR_OF_MEAN|4.016|<|0.0001|TWO_SIDED|95.0|-71.99|-56.24||P-values are from a GEE model including baseline value and visit (in this study) as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||Week 24||-56.24|-71.99|< 0.0001
71078753|NCT02432144|141665460|SUPERIORITY||LS Mean|-60.8|STANDARD_ERROR_OF_MEAN|5.992|<|0.0001|TWO_SIDED|95.0|-72.54|-49.06||P-values are from a GEE model including baseline value and visit (in this study) as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||Week 36||-49.06|-72.54|< 0.0001
71078754|NCT02432144|141665460|SUPERIORITY||LS Mean|-57.85|||<|0.0001|TWO_SIDED|95.0|-71.87|-43.82||P-values are from a GEE model including baseline value and visit (in this study) as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||Week 48||-43.82|-71.87|< 0.0001
71078755|NCT01031004|141665555|SUPERIORITY_OR_OTHER|||||||0.0466||95.0|||||Fisher Exact|||The hypothesis is that narafilcon B is not statistically different from etafilcon A.||||0.0466
71078756|NCT01031004|141665556|SUPERIORITY_OR_OTHER|||||||0.1069||95.0|||||Fisher Exact|||The hypothesis is that narafilcon B is not statistically different from etafilcon A.||||0.1069
71078757|NCT01031004|141665557|SUPERIORITY_OR_OTHER|||||||0.4605||95.0|||||Chi-squared|||The hypothesis is that narafilcon B is not statistically different from etafilcon A.||||0.4605
71078758|NCT01031004|141665558|SUPERIORITY_OR_OTHER|||||||0.5774||95.0|||||Chi-squared|||The hypothesis is that narafilcon B is not statistically different from etafilcon A.||||0.5774
71115141|NCT01942668|141737488|SUPERIORITY|||||||0.138||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 3|Fisher Exact|||||||0.138
71115142|NCT01942668|141737488|SUPERIORITY|||||||0.685||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 3|Fisher Exact|||||||0.685
71115143|NCT01942668|141737489|SUPERIORITY|||||||0.023||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 4|Fisher Exact|||||||0.023
71115144|NCT01942668|141737489|SUPERIORITY|||||||0.265||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 4|Fisher Exact|||||||0.265
71115145|NCT01942668|141737489|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 4|Fisher Exact|||||||1.000
71115146|NCT01942668|141737489|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 4|Fisher Exact|||||||1.000
71115147|NCT01942668|141737494|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|0.246|<|0.001|TWO_SIDED|95.0|-2.13|-1.17||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.17|-2.13|<0.001
71115148|NCT01942668|141737494|SUPERIORITY||Mean Difference (Final Values)|-1.31|STANDARD_ERROR_OF_MEAN|0.242|<|0.001|TWO_SIDED|95.0|-1.79|-0.84||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.84|-1.79|<0.001
71115149|NCT01942668|141737494|SUPERIORITY||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|0.242|<|0.001|TWO_SIDED|95.0|-1.64|-0.69||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.69|-1.64|<0.001
71115150|NCT01942668|141737494|SUPERIORITY||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.238|<|0.001|TWO_SIDED|95.0|-1.51|-0.58||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.58|-1.51|<0.001
71115151|NCT01942668|141737495|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.258|<|0.001|TWO_SIDED|95.0|-1.91|-0.89||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.89|-1.91|<0.001
71115152|NCT01942668|141737495|SUPERIORITY||Mean Difference (Final Values)|-1.32|STANDARD_ERROR_OF_MEAN|0.253|<|0.001|TWO_SIDED|95.0|-1.81|-0.82||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.82|-1.81|<0.001
71115153|NCT01942668|141737495|SUPERIORITY||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.257|<|0.001|TWO_SIDED|95.0|-1.63|-0.62||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.62|-1.63|<0.001
71115154|NCT01942668|141737495|SUPERIORITY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.254||0.007|TWO_SIDED|95.0|-1.19|-0.19||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.19|-1.19|0.007
71115155|NCT01942668|141737496|SUPERIORITY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.276|<|0.001|TWO_SIDED|95.0|-1.75|-0.66||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.66|-1.75|<0.001
71115156|NCT01942668|141737496|SUPERIORITY||Mean Difference (Final Values)|-1.46|STANDARD_ERROR_OF_MEAN|0.265|<|0.001|TWO_SIDED|95.0|-1.98|-0.94||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.94|-1.98|<0.001
71115157|NCT01942668|141737496|SUPERIORITY||Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|0.272|<|0.001|TWO_SIDED|95.0|-1.76|-0.69||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.69|-1.76|<0.001
71115158|NCT01942668|141737496|SUPERIORITY||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.272||0.008|TWO_SIDED|95.0|-1.26|-0.19||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.19|-1.26|0.008
71115159|NCT01942668|141737497|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.161||0.284|TWO_SIDED|95.0|-0.49|0.14||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.14|-0.49|0.284
71115160|NCT01942668|141737497|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.158||0.732|TWO_SIDED|95.0|-0.36|0.26||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.26|-0.36|0.732
70853413|NCT01185353|141194995|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED|||||P-value is for Low Disease Activity - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||0.007
70940311|NCT00141271|141380800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2695||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.2695
71072991|NCT00772005|141655701|SUPERIORITY_OR_OTHER|||||||0.0619||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0619
71072992|NCT00772005|141655701|SUPERIORITY_OR_OTHER|||||||0.1137||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1137
71072993|NCT00772005|141655701|SUPERIORITY_OR_OTHER|||||||0.0598||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0598
71072994|NCT00772005|141655702|SUPERIORITY_OR_OTHER|||||||0.7093||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7093
71072995|NCT00772005|141655702|SUPERIORITY_OR_OTHER|||||||0.5129||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5129
71072996|NCT00772005|141655702|SUPERIORITY_OR_OTHER|||||||0.1097||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1097
71072997|NCT00772005|141655703|SUPERIORITY_OR_OTHER|||||||0.4291||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4291
71072998|NCT00772005|141655703|SUPERIORITY_OR_OTHER|||||||0.3195||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3195
71072999|NCT00772005|141655703|SUPERIORITY_OR_OTHER|||||||0.1591||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1591
71073000|NCT00772005|141655704|SUPERIORITY_OR_OTHER|||||||0.7768||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7768
71073001|NCT00772005|141655704|SUPERIORITY_OR_OTHER|||||||0.4014||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4014
71073002|NCT00772005|141655704|SUPERIORITY_OR_OTHER|||||||0.4016||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4016
71073003|NCT00772005|141655705|SUPERIORITY_OR_OTHER|||||||0.5612||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5612
71073004|NCT00772005|141655705|SUPERIORITY_OR_OTHER|||||||0.9704||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9704
71078759|NCT01031004|141665559|SUPERIORITY_OR_OTHER|||||||0.6403||95.0|||||t-test, 2 sided|||The hypothesis is that narafilcon B will not be statistically different from etafilcon A.||||0.6403
71078760|NCT01031004|141665560|SUPERIORITY_OR_OTHER|||||||0.7217||95.0|||||t-test, 2 sided|||The hypothesis is that narafilcon B is not statistically different from etafilcon A.||||0.7217
71078761|NCT02634801|141665561|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|4.08|||<|0.0001|TWO_SIDED|95.0|2.46|6.77|||Fisher Exact|||||6.77|2.46|<.0001
71078762|NCT02634801|141665561|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.29||||0.0137|TWO_SIDED|95.0|1.06|1.56|||Fisher Exact|||||1.56|1.06|0.0137
71078763|NCT01649362|141665607|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||t-test, 2 sided|||||||0.63
71078764|NCT01649362|141665608|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||t-test, 2 sided|||||||0.36
71078765|NCT01649362|141665609|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Chi-squared|||||||0.02
71078766|NCT03441685|141665615|OTHER|Accuracy identifying taught verbs in syntactic vs semantic condition (receptive)||||||0.73||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.73
71078767|NCT03441685|141665615|OTHER|Accuracy identifying taught verbs in syntactic vs semantic condition (receptive)||||||0.69||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.69
71078768|NCT03441685|141665615|OTHER|Accuracy identifying taught verbs in syntactic vs semantic condition (receptive)||||||0.79||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.79
71078769|NCT03441685|141665615|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.002||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.002
71073005|NCT00772005|141655705|SUPERIORITY_OR_OTHER|||||||0.2424||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2424
71073006|NCT00772005|141655706|SUPERIORITY_OR_OTHER|||||||0.8847||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8847
71073007|NCT00772005|141655706|SUPERIORITY_OR_OTHER|||||||0.2958||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2958
71073008|NCT00772005|141655706|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2660
71073009|NCT00772005|141655707|SUPERIORITY_OR_OTHER|||||||0.0524||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0524
71073010|NCT00772005|141655707|SUPERIORITY_OR_OTHER|||||||0.0328||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0328
71073011|NCT00772005|141655707|SUPERIORITY_OR_OTHER|||||||0.0084||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0084
71073012|NCT00772005|141655708|SUPERIORITY_OR_OTHER|||||||0.3651||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3651
71073013|NCT00772005|141655708|SUPERIORITY_OR_OTHER|||||||0.0096||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0096
71073014|NCT00772005|141655708|SUPERIORITY_OR_OTHER|||||||0.0327||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0327
71073015|NCT00772005|141655709|SUPERIORITY_OR_OTHER|||||||0.2091||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2091
71073016|NCT00772005|141655709|SUPERIORITY_OR_OTHER|||||||0.0706||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0706
71073017|NCT00772005|141655709|SUPERIORITY_OR_OTHER|||||||0.3052||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3052
71073018|NCT00772005|141655710|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9960
71073019|NCT00772005|141655710|SUPERIORITY_OR_OTHER|||||||0.3604||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3604
71073020|NCT00772005|141655710|SUPERIORITY_OR_OTHER|||||||0.9528||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9528
71073021|NCT00772005|141655711|SUPERIORITY_OR_OTHER|||||||0.9797||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9797
71073022|NCT00772005|141655711|SUPERIORITY_OR_OTHER|||||||0.6173||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6173
71073023|NCT00772005|141655711|SUPERIORITY_OR_OTHER|||||||0.5415||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5415
71073024|NCT00772005|141655712|SUPERIORITY_OR_OTHER|||||||0.3547||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3547
71078770|NCT03441685|141665615|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.049||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.049
71078771|NCT03441685|141665615|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.016||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.016
71078772|NCT03441685|141665616|OTHER|Accuracy identifying taught verbs in semantic vs combined condition (receptive)||||||0.76||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.76
71078773|NCT03441685|141665616|OTHER|Accuracy identifying taught verbs in semantic vs combined condition (receptive)||||||0.79||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.79
71073025|NCT00772005|141655712|SUPERIORITY_OR_OTHER|||||||0.6642||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6642
71073026|NCT00772005|141655712|SUPERIORITY_OR_OTHER|||||||0.7395||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7395
71073027|NCT00772005|141655713|SUPERIORITY_OR_OTHER|||||||0.8124||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8124
71073028|NCT00772005|141655713|SUPERIORITY_OR_OTHER|||||||0.8961||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8961
71073029|NCT00772005|141655713|SUPERIORITY_OR_OTHER|||||||0.4999||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4999
71073030|NCT00772005|141655723|SUPERIORITY_OR_OTHER|||||||0.454||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4540
71115161|NCT01942668|141737497|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.159||0.437|TWO_SIDED|95.0|-0.44|0.19||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.19|-0.44|0.437
70853414|NCT01185353|141194995|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|||||P-value is for Remission - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||0.033
70853415|NCT01185353|141194995|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED|||||P-value is for Remission - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||0.019
71073031|NCT00772005|141655723|SUPERIORITY_OR_OTHER|||||||0.358||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3580
71073032|NCT00772005|141655723|SUPERIORITY_OR_OTHER|||||||0.6271||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6271
71073033|NCT00772005|141655724|SUPERIORITY_OR_OTHER|||||||0.1459||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1459
71073034|NCT00772005|141655724|SUPERIORITY_OR_OTHER|||||||0.6004||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6004
71073035|NCT00772005|141655724|SUPERIORITY_OR_OTHER|||||||0.0192||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0192
71073036|NCT00772005|141655725|SUPERIORITY_OR_OTHER|||||||0.8455||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8455
71073037|NCT00772005|141655725|SUPERIORITY_OR_OTHER|||||||0.8715||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8715
71073038|NCT00772005|141655725|SUPERIORITY_OR_OTHER|||||||0.0309||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0309
71073039|NCT00772005|141655726|SUPERIORITY_OR_OTHER|||||||0.2664||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2664
71073040|NCT00772005|141655726|SUPERIORITY_OR_OTHER|||||||0.3528||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3528
71073041|NCT00772005|141655726|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0380
71073042|NCT00772005|141655727|SUPERIORITY_OR_OTHER|||||||0.3316||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3316
71115162|NCT01942668|141737497|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.156||0.439|TWO_SIDED|95.0|-0.43|0.19||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.19|-0.43|0.439
71115163|NCT01942668|141737498|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.169||0.04|TWO_SIDED|95.0|-0.68|-0.02||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.02|-0.68|0.040
71073043|NCT00772005|141655727|SUPERIORITY_OR_OTHER|||||||0.349||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3490
71073044|NCT00772005|141655727|SUPERIORITY_OR_OTHER|||||||0.0926||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0926
71073045|NCT00772005|141655728|SUPERIORITY_OR_OTHER|||||||0.8835||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8835
71073046|NCT00772005|141655728|SUPERIORITY_OR_OTHER|||||||0.9748||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9748
71073047|NCT00772005|141655728|SUPERIORITY_OR_OTHER|||||||0.0883||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0883
71073048|NCT00772005|141655729|SUPERIORITY_OR_OTHER|||||||0.6948||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6948
71073049|NCT00772005|141655729|SUPERIORITY_OR_OTHER|||||||0.3345||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3345
71073050|NCT00772005|141655729|SUPERIORITY_OR_OTHER|||||||0.2447||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2447
71078774|NCT03441685|141665616|OTHER|Accuracy identifying taught verbs in semantic vs combined condition (receptive)||||||1||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||1.00
71078775|NCT03441685|141665616|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.003||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.003
71078776|NCT03441685|141665616|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.029||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.029
71078777|NCT03441685|141665616|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.027||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.027
71078778|NCT03441685|141665617|OTHER|Accuracy identifying taught verbs in syntactic vs combined condition (receptive)||||||0.72||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.72
71078779|NCT03441685|141665617|OTHER|Accuracy identifying taught verbs in syntactic vs combined condition (receptive)||||||0.46||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.46
70853416|NCT01185353|141194995|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Remission - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||<0.001
71078780|NCT03441685|141665617|OTHER|Accuracy identifying taught verbs in syntactic vs combined condition (receptive)||||||0.89||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.89
71078781|NCT03441685|141665617|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.|||||<|0.001||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||<.001
71073051|NCT00772005|141655730|SUPERIORITY_OR_OTHER|||||||0.6115||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6115
71073052|NCT00772005|141655730|SUPERIORITY_OR_OTHER|||||||0.2233||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2233
71073053|NCT00772005|141655730|SUPERIORITY_OR_OTHER|||||||0.2343||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2343
71073054|NCT00772005|141655731|SUPERIORITY_OR_OTHER|||||||0.8228||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8228
71073055|NCT00772005|141655731|SUPERIORITY_OR_OTHER|||||||0.9373||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9373
71073056|NCT00772005|141655731|SUPERIORITY_OR_OTHER|||||||0.319||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3190
71115164|NCT01942668|141737498|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.165||0.066|TWO_SIDED|95.0|-0.63|0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.02|-0.63|0.066
71115165|NCT01942668|141737498|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.168||0.469|TWO_SIDED|95.0|-0.45|0.21||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.21|-0.45|0.469
71115166|NCT01942668|141737498|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.166||0.616|TWO_SIDED|95.0|-0.41|0.24||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.24|-0.41|0.616
71073057|NCT00772005|141655732|SUPERIORITY_OR_OTHER|||||||0.9769||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9769
71073058|NCT00772005|141655732|SUPERIORITY_OR_OTHER|||||||0.8374||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8374
71073059|NCT00772005|141655732|SUPERIORITY_OR_OTHER|||||||0.7061||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7061
71073060|NCT00772005|141655733|SUPERIORITY_OR_OTHER|||||||0.9577||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9577
71115167|NCT01942668|141737499|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.183||0.25|TWO_SIDED|95.0|-0.57|0.15||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.15|-0.57|0.250
70853417|NCT01185353|141194995|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value is for Remission - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||0.001
70853418|NCT01185353|141194997|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.015
71073061|NCT00772005|141655733|SUPERIORITY_OR_OTHER|||||||0.5106||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5106
71115168|NCT01942668|141737499|SUPERIORITY||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.175||0.002|TWO_SIDED|95.0|-0.88|-0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.20|-0.88|0.002
70853419|NCT01185353|141194997|SUPERIORITY_OR_OTHER|||||||0.073|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.073
70853420|NCT01185353|141194997|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
70853421|NCT01185353|141194997|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
71073062|NCT00772005|141655733|SUPERIORITY_OR_OTHER|||||||0.2655||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2655
71073063|NCT00772005|141655734|SUPERIORITY_OR_OTHER|||||||0.3825||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3825
71115169|NCT01942668|141737499|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.179||0.796|TWO_SIDED|95.0|-0.4|0.31||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.31|-0.40|0.796
71115170|NCT01942668|141737499|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.179||0.955|TWO_SIDED|95.0|-0.36|0.34||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.34|-0.36|0.955
71073064|NCT00772005|141655734|SUPERIORITY_OR_OTHER|||||||0.2003||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2003
71073065|NCT00772005|141655734|SUPERIORITY_OR_OTHER|||||||0.0625||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0625
71073066|NCT00772005|141655735|SUPERIORITY_OR_OTHER|||||||0.2981||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2981
71073067|NCT00772005|141655735|SUPERIORITY_OR_OTHER|||||||0.0104||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0104
71073068|NCT00772005|141655735|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0150
71073069|NCT00772005|141655736|SUPERIORITY_OR_OTHER|||||||0.4608||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4608
70853422|NCT01185353|141194998|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED|||||P-value is for PCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.021
70853423|NCT01185353|141194998|SUPERIORITY_OR_OTHER|||||||0.194|TWO_SIDED|||||P-value is for PCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.194
70853424|NCT01185353|141194998|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for PCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
70853425|NCT01185353|141194998|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||P-value is for PCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.012
71073070|NCT00772005|141655736|SUPERIORITY_OR_OTHER|||||||0.0807||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0807
71073071|NCT00772005|141655736|SUPERIORITY_OR_OTHER|||||||0.2959||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2959
71073072|NCT00772005|141655737|SUPERIORITY_OR_OTHER|||||||0.6759||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6759
71073073|NCT00772005|141655737|SUPERIORITY_OR_OTHER|||||||0.2418||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2418
71078782|NCT03441685|141665617|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.018||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.018
71078783|NCT03441685|141665617|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.027||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.027
71078784|NCT03441685|141665618|OTHER|Accuracy labeling taught verbs in syntactic vs semantic condition (expressive)||||||0.64||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.64
71078785|NCT03441685|141665618|OTHER|Accuracy labeling taught verbs in syntactic vs semantic condition (expressive)||||||0.16||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.16
71078786|NCT03441685|141665618|OTHER|Accuracy labeling taught verbs in syntactic vs semantic condition (expressive)||||||0.18||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.18
71078787|NCT03441685|141665618|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0|||||<|0.001||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||<.001
71078788|NCT03441685|141665618|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.034||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.034
71078789|NCT03441685|141665618|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.063||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.063
71078790|NCT03441685|141665619|OTHER|Accuracy labeling taught verbs in semantic vs combined condition (expressive)||||||0.35||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.35
71078791|NCT03441685|141665619|OTHER|Accuracy labeling taught verbs in semantic vs combined condition (expressive)||||||0.18||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.18
71115171|NCT01942668|141737500|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.143||0.474|TWO_SIDED|95.0|-0.38|0.18||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.18|-0.38|0.474
71115172|NCT01942668|141737500|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.14||0.378|TWO_SIDED|95.0|-0.4|0.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.15|-0.40|0.378
71115173|NCT01942668|141737500|SUPERIORITY||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.141||0.018|TWO_SIDED|95.0|-0.61|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.06|-0.61|0.018
71115174|NCT01942668|141737500|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.138||0.73|TWO_SIDED|95.0|-0.32|0.22||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.22|-0.32|0.730
71115175|NCT01942668|141737501|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.152||0.197|TWO_SIDED|95.0|-0.49|0.1||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.10|-0.49|0.197
71115176|NCT01942668|141737501|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.148||0.308|TWO_SIDED|95.0|-0.44|0.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.14|-0.44|0.308
71073074|NCT00772005|141655737|SUPERIORITY_OR_OTHER|||||||0.9808||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9808
70853426|NCT01185353|141194998|SUPERIORITY_OR_OTHER|||||||0.449|TWO_SIDED|||||P-value is for MCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.449
70853427|NCT01185353|141194998|SUPERIORITY_OR_OTHER|||||||0.578|TWO_SIDED|||||P-value is for MCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.578
70853428|NCT01185353|141194998|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED|||||P-value is for MCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.140
71073075|NCT00772005|141655738|SUPERIORITY_OR_OTHER|||||||0.7599||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7599
70853429|NCT01185353|141194998|SUPERIORITY_OR_OTHER|||||||0.266|TWO_SIDED|||||P-value is for MCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.266
71073076|NCT00772005|141655738|SUPERIORITY_OR_OTHER|||||||0.4543||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4543
71073077|NCT00772005|141655738|SUPERIORITY_OR_OTHER|||||||0.604||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6040
71115177|NCT01942668|141737501|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.152||0.117|TWO_SIDED|95.0|-0.54|0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.06|-0.54|0.117
71115178|NCT01942668|141737501|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.149||0.739|TWO_SIDED|95.0|-0.34|0.24||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.24|-0.34|0.739
71115179|NCT01942668|141737502|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.171||0.635|TWO_SIDED|95.0|-0.42|0.26||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.26|-0.42|0.635
71115180|NCT01942668|141737502|SUPERIORITY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.164||0.01|TWO_SIDED|95.0|-0.75|-0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.10|-0.75|0.010
71115181|NCT01942668|141737502|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.169||0.092|TWO_SIDED|95.0|-0.62|0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.05|-0.62|0.092
71115182|NCT01942668|141737502|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.168||0.243|TWO_SIDED|95.0|-0.53|0.13||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.13|-0.53|0.243
71115183|NCT01942668|141737503|SUPERIORITY||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.21||0.049|TWO_SIDED|95.0|-0.83|0.0||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.00|-0.83|0.049
71115184|NCT01942668|141737503|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.206||0.773|TWO_SIDED|95.0|-0.34|0.46||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.46|-0.34|0.773
70853430|NCT01185353|141194999|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||ANCOVA|A priori p-value significance threshold: 2-sided ≤0.10.||||||0.005
71115185|NCT01942668|141737503|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.208||0.081|TWO_SIDED|95.0|-0.77|0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.05|-0.77|0.081
71115186|NCT01942668|141737503|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.204||0.625|TWO_SIDED|95.0|-0.5|0.3||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.30|-0.50|0.625
71115187|NCT01942668|141737504|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.221||0.221|TWO_SIDED|95.0|-0.7|0.16||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.16|-0.70|0.221
71115188|NCT01942668|141737504|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.214||0.992|TWO_SIDED|95.0|-0.42|0.42||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.42|-0.42|0.992
71115189|NCT01942668|141737504|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.219||0.181|TWO_SIDED|95.0|-0.72|0.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.14|-0.72|0.181
71115190|NCT01942668|141737504|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.216||0.846|TWO_SIDED|95.0|-0.47|0.38||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.38|-0.47|0.846
71115191|NCT01942668|141737505|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.257||0.421|TWO_SIDED|95.0|-0.71|0.3||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.30|-0.71|0.421
71115192|NCT01942668|141737505|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.244||0.044|TWO_SIDED|95.0|-0.97|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.01|-0.97|0.044
71115193|NCT01942668|141737505|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.252||0.093|TWO_SIDED|95.0|-0.92|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.07|-0.92|0.093
70853431|NCT01185353|141194999|SUPERIORITY_OR_OTHER|||||||0.135|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.135
71115194|NCT01942668|141737505|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.252||0.247|TWO_SIDED|95.0|-0.79|0.2||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.20|-0.79|0.247
71115195|NCT01942668|141737506|SUPERIORITY||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.145|<|0.001|TWO_SIDED|95.0|-0.87|-0.29||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.29|-0.87|<0.001
71115196|NCT01942668|141737506|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.143||0.016|TWO_SIDED|95.0|-0.62|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.06|-0.62|0.016
71115197|NCT01942668|141737506|SUPERIORITY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.143|<|0.001|TWO_SIDED|95.0|-0.76|-0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.20|-0.76|<0.001
71115198|NCT01942668|141737506|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.141||0.023|TWO_SIDED|95.0|-0.6|-0.05||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.05|-0.60|0.023
71115199|NCT01942668|141737507|SUPERIORITY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.84|-0.25||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.25|-0.84|<0.001
71115200|NCT01942668|141737507|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.146||0.004|TWO_SIDED|95.0|-0.71|-0.13||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.13|-0.71|0.004
71115201|NCT01942668|141737507|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.149||0.003|TWO_SIDED|95.0|-0.73|-0.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.14|-0.73|0.003
71115202|NCT01942668|141737507|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.147||0.179|TWO_SIDED|95.0|-0.49|0.09||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.09|-0.49|0.179
71115203|NCT01942668|141737508|SUPERIORITY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.169||0.012|TWO_SIDED|95.0|-0.76|-0.1||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.10|-0.76|0.012
71115204|NCT01942668|141737508|SUPERIORITY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.162|<|0.001|TWO_SIDED|95.0|-1.05|-0.41||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.41|-1.05|<0.001
71115205|NCT01942668|141737508|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.166||0.004|TWO_SIDED|95.0|-0.81|-0.16||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.16|-0.81|0.004
71073078|NCT00772005|141655739|SUPERIORITY_OR_OTHER|||||||0.2476||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2476
71073079|NCT00772005|141655739|SUPERIORITY_OR_OTHER|||||||0.949||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9490
71073080|NCT00772005|141655739|SUPERIORITY_OR_OTHER|||||||0.9035||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9035
71073081|NCT00772005|141655740|SUPERIORITY_OR_OTHER|||||||0.9472||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9472
71115206|NCT01942668|141737508|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.166||0.07|TWO_SIDED|95.0|-0.63|0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.03|-0.63|0.070
71115207|NCT01942668|141737509|SUPERIORITY||Mean Difference (Final Values)|-4.39|STANDARD_ERROR_OF_MEAN|2.059||0.033|TWO_SIDED|95.0|-8.44|-0.35||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.35|-8.44|0.033
71073082|NCT00772005|141655740|SUPERIORITY_OR_OTHER|||||||0.8335||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8335
71073083|NCT00772005|141655740|SUPERIORITY_OR_OTHER|||||||0.5674||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5674
71073084|NCT00772005|141655741|SUPERIORITY_OR_OTHER|||||||0.3536||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3536
71073085|NCT00772005|141655741|SUPERIORITY_OR_OTHER|||||||0.194||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1940
71073086|NCT00772005|141655741|SUPERIORITY_OR_OTHER|||||||0.2129||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2129
71073087|NCT00772005|141655742|SUPERIORITY_OR_OTHER|||||||0.584||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5840
71073088|NCT00772005|141655742|SUPERIORITY_OR_OTHER|||||||0.6028||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6028
71073089|NCT00772005|141655742|SUPERIORITY_OR_OTHER|||||||0.1426||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1426
71115208|NCT01942668|141737509|SUPERIORITY||Mean Difference (Final Values)|-2.54|STANDARD_ERROR_OF_MEAN|2.015||0.207|TWO_SIDED|95.0|-6.5|1.41||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||1.41|-6.50|0.207
71115209|NCT01942668|141737509|SUPERIORITY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|2.03||0.024|TWO_SIDED|95.0|-8.58|-0.61||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.61|-8.58|0.024
71115210|NCT01942668|141737509|SUPERIORITY||Mean Difference (Final Values)|-2.53|STANDARD_ERROR_OF_MEAN|2.007||0.207|TWO_SIDED|95.0|-6.47|1.41||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||1.41|-6.47|0.207
70853432|NCT01185353|141194999|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
71115211|NCT01942668|141737510|SUPERIORITY||Mean Difference (Final Values)|-5.48|STANDARD_ERROR_OF_MEAN|2.138||0.011|TWO_SIDED|95.0|-9.68|-1.28||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.28|-9.68|0.011
71115212|NCT01942668|141737510|SUPERIORITY||Mean Difference (Final Values)|-5.25|STANDARD_ERROR_OF_MEAN|2.093||0.012|TWO_SIDED|95.0|-9.36|-1.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.14|-9.36|0.012
71115213|NCT01942668|141737510|SUPERIORITY||Mean Difference (Final Values)|-5.58|STANDARD_ERROR_OF_MEAN|2.122||0.009|TWO_SIDED|95.0|-9.75|-1.41||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.41|-9.75|0.009
71115214|NCT01942668|141737510|SUPERIORITY||Mean Difference (Final Values)|-4.99|STANDARD_ERROR_OF_MEAN|2.096||0.018|TWO_SIDED|95.0|-9.11|-0.87||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.87|-9.11|0.018
71073090|NCT00772005|141655743|SUPERIORITY_OR_OTHER|||||||0.5989||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5989
71115215|NCT01942668|141737511|SUPERIORITY||Mean Difference (Final Values)|-4.61|STANDARD_ERROR_OF_MEAN|2.427||0.058|TWO_SIDED|95.0|-9.38|0.16||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.16|-9.38|0.058
71115216|NCT01942668|141737511|SUPERIORITY||Mean Difference (Final Values)|-7.48|STANDARD_ERROR_OF_MEAN|2.322||0.001|TWO_SIDED|95.0|-12.04|-2.92||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.92|-12.04|0.001
70940312|NCT00141271|141380800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3245||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.3245
71073091|NCT00772005|141655743|SUPERIORITY_OR_OTHER|||||||0.7411||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7411
71073092|NCT00772005|141655743|SUPERIORITY_OR_OTHER|||||||0.1566||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1566
71115217|NCT01942668|141737511|SUPERIORITY||Mean Difference (Final Values)|-7.96|STANDARD_ERROR_OF_MEAN|2.397|<|0.001|TWO_SIDED|95.0|-12.67|-3.25||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.25|-12.67|<0.001
71115218|NCT01942668|141737511|SUPERIORITY||Mean Difference (Final Values)|-6.78|STANDARD_ERROR_OF_MEAN|2.404||0.005|TWO_SIDED|95.0|-11.5|-2.06||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.06|-11.50|0.005
71115219|NCT01942668|141737512|SUPERIORITY||Mean Difference (Final Values)|-6.48|STANDARD_ERROR_OF_MEAN|2.77||0.02|TWO_SIDED|95.0|-11.92|-1.04||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.04|-11.92|0.020
71073093|NCT00772005|141655744|SUPERIORITY_OR_OTHER|||||||0.261||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2610
71073094|NCT00772005|141655744|SUPERIORITY_OR_OTHER|||||||0.4457||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4457
71115220|NCT01942668|141737512|SUPERIORITY||Mean Difference (Final Values)|-3.36|STANDARD_ERROR_OF_MEAN|2.715||0.216|TWO_SIDED|95.0|-8.69|1.97||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||1.97|-8.69|0.216
71115221|NCT01942668|141737512|SUPERIORITY||Mean Difference (Final Values)|-5.85|STANDARD_ERROR_OF_MEAN|2.734||0.033|TWO_SIDED|95.0|-11.22|-0.48||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.48|-11.22|0.033
71115222|NCT01942668|141737512|SUPERIORITY||Mean Difference (Final Values)|-2.99|STANDARD_ERROR_OF_MEAN|2.685||0.265|TWO_SIDED|95.0|-8.27|2.28||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||2.28|-8.27|0.265
71115223|NCT01942668|141737513|SUPERIORITY||Mean Difference (Final Values)|-7.54|STANDARD_ERROR_OF_MEAN|2.854||0.008|TWO_SIDED|95.0|-13.14|-1.93||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.93|-13.14|0.008
71115224|NCT01942668|141737513|SUPERIORITY||Mean Difference (Final Values)|-6.72|STANDARD_ERROR_OF_MEAN|2.781||0.016|TWO_SIDED|95.0|-12.18|-1.26||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.26|-12.18|0.016
71115225|NCT01942668|141737513|SUPERIORITY||Mean Difference (Final Values)|-8.69|STANDARD_ERROR_OF_MEAN|2.847||0.002|TWO_SIDED|95.0|-14.28|-3.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-3.10|-14.28|0.002
71115226|NCT01942668|141737513|SUPERIORITY||Mean Difference (Final Values)|-6.18|STANDARD_ERROR_OF_MEAN|2.8||0.028|TWO_SIDED|95.0|-11.68|-0.68||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.68|-11.68|0.028
71115227|NCT01942668|141737514|SUPERIORITY||Mean Difference (Final Values)|-6.56|STANDARD_ERROR_OF_MEAN|3.18||0.04|TWO_SIDED|95.0|-12.8|-0.31||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.31|-12.80|0.040
71115228|NCT01942668|141737514|SUPERIORITY||Mean Difference (Final Values)|-10.02|STANDARD_ERROR_OF_MEAN|3.04||0.001|TWO_SIDED|95.0|-15.99|-4.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-4.04|-15.99|0.001
71115229|NCT01942668|141737514|SUPERIORITY||Mean Difference (Final Values)|-9.96|STANDARD_ERROR_OF_MEAN|3.129||0.002|TWO_SIDED|95.0|-16.11|-3.81||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.81|-16.11|0.002
71115230|NCT01942668|141737514|SUPERIORITY||Mean Difference (Final Values)|-6.85|STANDARD_ERROR_OF_MEAN|3.127||0.029|TWO_SIDED|95.0|-12.99|-0.7||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.70|-12.99|0.029
71073095|NCT00772005|141655744|SUPERIORITY_OR_OTHER|||||||0.1342||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1342
71073096|NCT00772005|141655745|SUPERIORITY_OR_OTHER|||||||0.0974||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0974
71115231|NCT01942668|141737515|SUPERIORITY||Mean Difference (Final Values)|3.15|STANDARD_ERROR_OF_MEAN|3.003||0.294|TWO_SIDED|95.0|-2.75|9.05||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||9.05|-2.75|0.294
71115232|NCT01942668|141737515|SUPERIORITY||Mean Difference (Final Values)|2.86|STANDARD_ERROR_OF_MEAN|2.922||0.327|TWO_SIDED|95.0|-2.87|8.6||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||8.60|-2.87|0.327
71115233|NCT01942668|141737515|SUPERIORITY||Mean Difference (Final Values)|-1.39|STANDARD_ERROR_OF_MEAN|2.947||0.637|TWO_SIDED|95.0|-7.18|4.39||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||4.39|-7.18|0.637
71115234|NCT01942668|141737515|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|2.893||0.952|TWO_SIDED|95.0|-5.51|5.86||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||5.86|-5.51|0.952
71115235|NCT01942668|141737516|SUPERIORITY||Mean Difference (Final Values)|1.82|STANDARD_ERROR_OF_MEAN|3.219||0.573|TWO_SIDED|95.0|-4.51|8.14||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||8.14|-4.51|0.573
71115236|NCT01942668|141737516|SUPERIORITY||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|3.107||0.769|TWO_SIDED|95.0|-7.01|5.19||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||5.19|-7.01|0.769
71115237|NCT01942668|141737516|SUPERIORITY||Mean Difference (Final Values)|-6.33|STANDARD_ERROR_OF_MEAN|3.176||0.047|TWO_SIDED|95.0|-12.56|-0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.09|-12.56|0.047
71115238|NCT01942668|141737516|SUPERIORITY||Mean Difference (Final Values)|-2.59|STANDARD_ERROR_OF_MEAN|3.133||0.409|TWO_SIDED|95.0|-8.74|3.56||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||3.56|-8.74|0.409
70940313|NCT00141271|141380800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7791||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.7791
71073097|NCT00772005|141655745|SUPERIORITY_OR_OTHER|||||||0.664||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6640
71073098|NCT00772005|141655745|SUPERIORITY_OR_OTHER|||||||0.1507||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1507
71073099|NCT00772005|141655746|SUPERIORITY_OR_OTHER|||||||0.7649||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7649
71073100|NCT00772005|141655746|SUPERIORITY_OR_OTHER|||||||0.4866||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4866
71073101|NCT00772005|141655746|SUPERIORITY_OR_OTHER|||||||0.5002||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5002
71073102|NCT00772005|141655747|SUPERIORITY_OR_OTHER|||||||0.2076||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2076
71073103|NCT00772005|141655747|SUPERIORITY_OR_OTHER|||||||0.9355||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9355
71073104|NCT00772005|141655747|SUPERIORITY_OR_OTHER|||||||0.189||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1890
71073105|NCT00772005|141655748|SUPERIORITY_OR_OTHER|||||||0.632||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6320
71073106|NCT00772005|141655748|SUPERIORITY_OR_OTHER|||||||0.8777||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8777
71073107|NCT00772005|141655748|SUPERIORITY_OR_OTHER|||||||0.4378||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4378
71073108|NCT00772005|141655749|SUPERIORITY_OR_OTHER|||||||0.5544||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5544
71073109|NCT00772005|141655749|SUPERIORITY_OR_OTHER|||||||0.4446||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4446
71073110|NCT00772005|141655749|SUPERIORITY_OR_OTHER|||||||0.4483||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4483
71073111|NCT00772005|141655750|SUPERIORITY_OR_OTHER|||||||0.1914||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1914
71073112|NCT00772005|141655750|SUPERIORITY_OR_OTHER|||||||0.2543||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2543
71115239|NCT01942668|141737517|SUPERIORITY||Mean Difference (Final Values)|1.91|STANDARD_ERROR_OF_MEAN|3.443||0.579|TWO_SIDED|95.0|-4.85|8.67||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||8.67|-4.85|0.579
71115240|NCT01942668|141737517|SUPERIORITY||Mean Difference (Final Values)|-3.99|STANDARD_ERROR_OF_MEAN|3.275||0.223|TWO_SIDED|95.0|-10.43|2.44||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||2.44|-10.43|0.223
71073113|NCT00772005|141655750|SUPERIORITY_OR_OTHER|||||||0.9748||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9748
71073114|NCT00772005|141655751|SUPERIORITY_OR_OTHER|||||||0.5312||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5312
71073115|NCT00772005|141655751|SUPERIORITY_OR_OTHER|||||||0.7522||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7522
71078792|NCT03441685|141665619|OTHER|Accuracy labeling taught verbs in semantic vs combined condition (expressive)||||||0.58|||||||Wilcoxon Signed Ranks Test|||||||0.58
71078793|NCT03441685|141665619|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.006||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.006
71078794|NCT03441685|141665619|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.02||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.02
71078795|NCT03441685|141665619|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.18||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.18
71078796|NCT03441685|141665620|OTHER|Accuracy labeling taught verbs in syntactic vs combined condition (expressive)||||||0.56||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.56
71078797|NCT03441685|141665620|OTHER|Accuracy labeling taught verbs in syntactic vs combined condition (expressive)||||||0.1||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.10
71078798|NCT03441685|141665620|OTHER|Accuracy labeling taught verbs in syntactic vs combined condition (expressive)||||||0.71||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.71
71078799|NCT03441685|141665620|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0|||||<|0.001||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||<.001
71078800|NCT03441685|141665620|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.024||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.024
71073116|NCT00772005|141655751|SUPERIORITY_OR_OTHER|||||||0.3183||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3183
71073117|NCT00772005|141655752|SUPERIORITY_OR_OTHER|||||||0.5879||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5879
71073118|NCT00772005|141655752|SUPERIORITY_OR_OTHER|||||||0.891||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8910
71073119|NCT00772005|141655752|SUPERIORITY_OR_OTHER|||||||0.1795||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1795
71073120|NCT00772005|141655753|SUPERIORITY_OR_OTHER|||||||0.6378||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6378
71073121|NCT00772005|141655753|SUPERIORITY_OR_OTHER|||||||0.8679||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8679
71073122|NCT00772005|141655753|SUPERIORITY_OR_OTHER|||||||0.5489||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5489
71073123|NCT00772005|141655754|SUPERIORITY_OR_OTHER|||||||0.9337||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9337
71073124|NCT00772005|141655754|SUPERIORITY_OR_OTHER|||||||0.9428||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9428
71073125|NCT00772005|141655754|SUPERIORITY_OR_OTHER|||||||0.5895||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5895
71078801|NCT03441685|141665620|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.1||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.10
71078802|NCT01796301|141665646|SUPERIORITY|A two-step, step-down, fixed-sequential testing procedure was used to test the primary and key secondary efficacy endpoints for the comparison of romosozumab to teriparatide in the order presented for multiplicity adjustment to maintain the overall significance level at 0.05. The Key Secondary Efficacy Endpoints are the first 8 secondary endpoints reported below.|Treatment difference|3.2|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.7|3.8|||Linear mixed effects repeated measures|||The primary analysis to assess the treatment difference (Romosozumab - Teriparatide) employed a linear mixed effects model for repeated measures. The model included main effects for treatment group, visit (categorical), baseline sCTX, baseline hip DXA BMD value, machine type (categorical), and machine type-by-baseline value interaction (to adjust for the effect of machine type on baseline DXA BMD value) as fixed main effects using an unstructured within-subject variance-covariance structure.||3.8|2.7|< 0.0001
71078803|NCT01796301|141665647|SUPERIORITY||Treatment difference|3.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.5|3.7|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.||3.7|2.5|< 0.0001
71078804|NCT01796301|141665648|SUPERIORITY||Treatment difference|3.4|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.8|4.0|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.||4.0|2.8|< 0.0001
71078805|NCT01796301|141665649|SUPERIORITY||Treatment difference|3.4|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.8|4.0|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||4.0|2.8|< 0.0001
71078806|NCT01796301|141665650|SUPERIORITY||Treatment difference|4.6|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|3.9|5.3|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||5.3|3.9|< 0.0001
71078807|NCT01796301|141665651|SUPERIORITY||Treatment difference|3.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.5|3.6|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||3.6|2.5|< 0.0001
71073126|NCT00772005|141655755|SUPERIORITY_OR_OTHER|||||||0.8695||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8695
71115241|NCT01942668|141737517|SUPERIORITY||Mean Difference (Final Values)|-2.05|STANDARD_ERROR_OF_MEAN|3.367||0.542|TWO_SIDED|95.0|-8.67|4.56||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||4.56|-8.67|0.542
71073127|NCT00772005|141655755|SUPERIORITY_OR_OTHER|||||||0.6637||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6637
71073128|NCT00772005|141655755|SUPERIORITY_OR_OTHER|||||||0.3152||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3152
71073129|NCT00772005|141655756|SUPERIORITY_OR_OTHER|||||||0.7472||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7472
71073130|NCT00772005|141655756|SUPERIORITY_OR_OTHER|||||||0.4503||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4503
71073131|NCT00772005|141655756|SUPERIORITY_OR_OTHER|||||||0.3127||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3127
71073132|NCT00772005|141655757|SUPERIORITY_OR_OTHER|||||||0.9193||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9193
71073133|NCT00772005|141655757|SUPERIORITY_OR_OTHER|||||||0.4814||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4814
71073134|NCT00772005|141655757|SUPERIORITY_OR_OTHER|||||||0.6097||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6097
71073135|NCT00772005|141655758|SUPERIORITY_OR_OTHER|||||||0.8594||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8594
71073136|NCT00772005|141655758|SUPERIORITY_OR_OTHER|||||||0.6157||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6157
71073137|NCT00772005|141655758|SUPERIORITY_OR_OTHER|||||||0.4846||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4846
71115242|NCT01942668|141737517|SUPERIORITY||Mean Difference (Final Values)|-2.41|STANDARD_ERROR_OF_MEAN|3.376||0.476|TWO_SIDED|95.0|-9.04|4.23||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||4.23|-9.04|0.476
70853433|NCT01185353|141194999|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.001
71073138|NCT00772005|141655759|SUPERIORITY_OR_OTHER|||||||0.6076||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6076
71115243|NCT01942668|141737518|SUPERIORITY||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|2.593||0.631|TWO_SIDED|95.0|-6.34|3.84||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||3.84|-6.34|0.631
71115244|NCT01942668|141737518|SUPERIORITY||Mean Difference (Final Values)|1.15|STANDARD_ERROR_OF_MEAN|2.54||0.651|TWO_SIDED|95.0|-3.84|6.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||6.14|-3.84|0.651
71115245|NCT01942668|141737518|SUPERIORITY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|2.578||0.813|TWO_SIDED|95.0|-5.67|4.45||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||4.45|-5.67|0.813
71115246|NCT01942668|141737518|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|2.515||0.869|TWO_SIDED|95.0|-5.35|4.52||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||4.52|-5.35|0.869
71115247|NCT01942668|141737519|SUPERIORITY||Mean Difference (Final Values)|-5.0|STANDARD_ERROR_OF_MEAN|2.79||0.074|TWO_SIDED|95.0|-10.48|0.48||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.48|-10.48|0.074
71115248|NCT01942668|141737519|SUPERIORITY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|2.722||0.748|TWO_SIDED|95.0|-6.22|4.47||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||4.47|-6.22|0.748
71115249|NCT01942668|141737519|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|2.805||0.987|TWO_SIDED|95.0|-5.46|5.56||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||5.56|-5.46|0.987
71115250|NCT01942668|141737519|SUPERIORITY||Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|2.741||0.709|TWO_SIDED|95.0|-6.41|4.36||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||4.36|-6.41|0.709
71115251|NCT01942668|141737520|SUPERIORITY||Mean Difference (Final Values)|-2.61|STANDARD_ERROR_OF_MEAN|2.968||0.379|TWO_SIDED|95.0|-8.44|3.22||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||3.22|-8.44|0.379
71115252|NCT01942668|141737520|SUPERIORITY||Mean Difference (Final Values)|-3.07|STANDARD_ERROR_OF_MEAN|2.832||0.279|TWO_SIDED|95.0|-8.64|2.49||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||2.49|-8.64|0.279
71115253|NCT01942668|141737520|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|2.949||0.894|TWO_SIDED|95.0|-6.19|5.4||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||5.40|-6.19|0.894
71115254|NCT01942668|141737520|SUPERIORITY||Mean Difference (Final Values)|-2.98|STANDARD_ERROR_OF_MEAN|2.923||0.308|TWO_SIDED|95.0|-8.72|2.76||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||2.76|-8.72|0.308
70940314|NCT00141271|141380800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0999||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.0999
71115255|NCT01942668|141737521|SUPERIORITY||Mean Difference (Final Values)|1.81|STANDARD_ERROR_OF_MEAN|3.081||0.558|TWO_SIDED|95.0|-4.24|7.86||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||7.86|-4.24|0.558
71115256|NCT01942668|141737521|SUPERIORITY||Mean Difference (Final Values)|3.61|STANDARD_ERROR_OF_MEAN|3.031||0.233|TWO_SIDED|95.0|-2.34|9.57||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||9.57|-2.34|0.233
71115257|NCT01942668|141737521|SUPERIORITY||Mean Difference (Final Values)|6.16|STANDARD_ERROR_OF_MEAN|3.036||0.043|TWO_SIDED|95.0|0.2|12.13||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||12.13|0.20|0.043
71115258|NCT01942668|141737521|SUPERIORITY||Mean Difference (Final Values)|2.07|STANDARD_ERROR_OF_MEAN|2.99||0.488|TWO_SIDED|95.0|-3.8|7.95||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||7.95|-3.80|0.488
71115259|NCT01942668|141737522|SUPERIORITY||Mean Difference (Final Values)|4.07|STANDARD_ERROR_OF_MEAN|3.206||0.205|TWO_SIDED|95.0|-2.23|10.37||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||10.37|-2.23|0.205
71115260|NCT01942668|141737522|SUPERIORITY||Mean Difference (Final Values)|9.58|STANDARD_ERROR_OF_MEAN|3.133||0.002|TWO_SIDED|95.0|3.43|15.74||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||15.74|3.43|0.002
71115261|NCT01942668|141737522|SUPERIORITY||Mean Difference (Final Values)|5.04|STANDARD_ERROR_OF_MEAN|3.193||0.115|TWO_SIDED|95.0|-1.23|11.32||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||11.32|-1.23|0.115
70853434|NCT01185353|141195000|SUPERIORITY_OR_OTHER|||||||0.203|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.203
71073139|NCT00772005|141655759|SUPERIORITY_OR_OTHER|||||||0.5827||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5827
71073140|NCT00772005|141655759|SUPERIORITY_OR_OTHER|||||||0.7865||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7865
71115262|NCT01942668|141737522|SUPERIORITY||Mean Difference (Final Values)|8.94|STANDARD_ERROR_OF_MEAN|3.152||0.005|TWO_SIDED|95.0|2.75|15.13||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||15.13|2.75|0.005
71073141|NCT00772005|141655760|SUPERIORITY_OR_OTHER|||||||0.3045||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3045
71115263|NCT01942668|141737523|SUPERIORITY||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|3.719||0.796|TWO_SIDED|95.0|-6.34|8.27||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||8.27|-6.34|0.796
71115264|NCT01942668|141737523|SUPERIORITY||Mean Difference (Final Values)|5.14|STANDARD_ERROR_OF_MEAN|3.568||0.15|TWO_SIDED|95.0|-1.87|12.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||12.15|-1.87|0.150
71115265|NCT01942668|141737523|SUPERIORITY||Mean Difference (Final Values)|8.58|STANDARD_ERROR_OF_MEAN|3.657||0.019|TWO_SIDED|95.0|1.39|15.77||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||15.77|1.39|0.019
71115266|NCT01942668|141737523|SUPERIORITY||Mean Difference (Final Values)|7.51|STANDARD_ERROR_OF_MEAN|3.667||0.041|TWO_SIDED|95.0|0.3|14.71||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||14.71|0.30|0.041
71115267|NCT01942668|141737524|SUPERIORITY||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|2.197||0.221|TWO_SIDED|95.0|-7.0|1.62||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||1.62|-7.00|0.221
71115268|NCT01942668|141737524|SUPERIORITY||Mean Difference (Final Values)|-1.42|STANDARD_ERROR_OF_MEAN|2.154||0.511|TWO_SIDED|95.0|-5.65|2.81||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||2.81|-5.65|0.511
71115269|NCT01942668|141737524|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|2.168||0.761|TWO_SIDED|95.0|-3.6|4.92||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||4.92|-3.60|0.761
71115270|NCT01942668|141737524|SUPERIORITY||Mean Difference (Final Values)|-2.07|STANDARD_ERROR_OF_MEAN|2.128||0.332|TWO_SIDED|95.0|-6.25|2.11||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||2.11|-6.25|0.332
71115271|NCT01942668|141737525|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|2.474||0.687|TWO_SIDED|95.0|-5.86|3.86||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||3.86|-5.86|0.687
71115272|NCT01942668|141737525|SUPERIORITY||Mean Difference (Final Values)|-2.15|STANDARD_ERROR_OF_MEAN|2.411||0.373|TWO_SIDED|95.0|-6.88|2.58||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||2.58|-6.88|0.373
71115273|NCT01942668|141737525|SUPERIORITY||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|2.466||0.714|TWO_SIDED|95.0|-5.75|3.94||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||3.94|-5.75|0.714
71115274|NCT01942668|141737525|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|2.427||0.711|TWO_SIDED|95.0|-5.67|3.87||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||3.87|-5.67|0.711
71115275|NCT01942668|141737526|SUPERIORITY||Mean Difference (Final Values)|-2.19|STANDARD_ERROR_OF_MEAN|2.682||0.415|TWO_SIDED|95.0|-7.46|3.08||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||3.08|-7.46|0.415
71115276|NCT01942668|141737526|SUPERIORITY||Mean Difference (Final Values)|-6.01|STANDARD_ERROR_OF_MEAN|2.564||0.019|TWO_SIDED|95.0|-11.04|-0.97||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.97|-11.04|0.019
71115277|NCT01942668|141737526|SUPERIORITY||Mean Difference (Final Values)|-4.72|STANDARD_ERROR_OF_MEAN|2.639||0.074|TWO_SIDED|95.0|-9.9|0.46||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.46|-9.90|0.074
71115278|NCT01942668|141737526|SUPERIORITY||Mean Difference (Final Values)|-5.75|STANDARD_ERROR_OF_MEAN|2.637||0.03|TWO_SIDED|95.0|-10.94|-0.57||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.57|-10.94|0.030
71115279|NCT01942668|141737527|SUPERIORITY||Mean Difference (Final Values)|-3.99|STANDARD_ERROR_OF_MEAN|2.109||0.059|TWO_SIDED|95.0|-8.13|0.16||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.16|-8.13|0.059
71115280|NCT01942668|141737527|SUPERIORITY||Mean Difference (Final Values)|-2.57|STANDARD_ERROR_OF_MEAN|2.067||0.215|TWO_SIDED|95.0|-6.63|1.49||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||1.49|-6.63|0.215
71115281|NCT01942668|141737527|SUPERIORITY||Mean Difference (Final Values)|-5.1|STANDARD_ERROR_OF_MEAN|2.084||0.015|TWO_SIDED|95.0|-9.19|-1.0||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.00|-9.19|0.015
70853435|NCT01185353|141195000|SUPERIORITY_OR_OTHER|||||||0.164|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.164
71073142|NCT00772005|141655760|SUPERIORITY_OR_OTHER|||||||0.0617||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0617
71073143|NCT00772005|141655760|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0580
71073144|NCT00772005|141655761|SUPERIORITY_OR_OTHER|||||||0.0194||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0194
71073145|NCT00772005|141655761|SUPERIORITY_OR_OTHER|||||||0.227||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2270
71073146|NCT00772005|141655761|SUPERIORITY_OR_OTHER|||||||0.1181||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1181
71073147|NCT00772005|141655762|SUPERIORITY_OR_OTHER|||||||0.1348||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1348
71073148|NCT00772005|141655762|SUPERIORITY_OR_OTHER|||||||0.0419||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0419
71073149|NCT00772005|141655762|SUPERIORITY_OR_OTHER|||||||0.0146||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0146
71073150|NCT00772005|141655763|SUPERIORITY_OR_OTHER|||||||0.1292||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1292
71073151|NCT00772005|141655763|SUPERIORITY_OR_OTHER|||||||0.3773||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3773
71073152|NCT00772005|141655763|SUPERIORITY_OR_OTHER|||||||0.1348||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1348
70853436|NCT01185353|141195000|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.018
70853437|NCT01185353|141195000|SUPERIORITY_OR_OTHER|||||||0.097|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.097
71073153|NCT00772005|141655764|SUPERIORITY_OR_OTHER|||||||0.9642||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9642
71073154|NCT00772005|141655764|SUPERIORITY_OR_OTHER|||||||0.7814||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7814
71073155|NCT00772005|141655764|SUPERIORITY_OR_OTHER|||||||0.1455||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1455
70940315|NCT00141271|141380800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9543||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.9543
70940316|NCT00141271|141380800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3153||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.3153
70940317|NCT00141271|141380801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2878||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.2878
71073156|NCT00772005|141655765|SUPERIORITY_OR_OTHER|||||||0.5722||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5722
70940318|NCT00141271|141380801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4481||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.4481
70940319|NCT00141271|141380801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4099||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.4099
70940320|NCT00141271|141380801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5093||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value.||Week 2||||0.5093
70940321|NCT00141271|141380801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8048||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value.||Week 3||||0.8048
71073157|NCT00772005|141655765|SUPERIORITY_OR_OTHER|||||||0.1352||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1352
71115282|NCT01942668|141737527|SUPERIORITY||Mean Difference (Final Values)|-3.16|STANDARD_ERROR_OF_MEAN|2.042||0.122|TWO_SIDED|95.0|-7.17|0.85||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.85|-7.17|0.122
70940322|NCT00141271|141380801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0552||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.0552
70940323|NCT00141271|141380801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9795||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.9795
70940324|NCT00141271|141380801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5073||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.5073
70940325|NCT00141271|141380801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4882||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.4882
70940326|NCT00141271|141380801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3967||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.3967
71073158|NCT00772005|141655765|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0630
71073159|NCT00772005|141655766|SUPERIORITY_OR_OTHER|||||||0.4607||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4607
71115283|NCT01942668|141737528|SUPERIORITY||Mean Difference (Final Values)|-5.32|STANDARD_ERROR_OF_MEAN|2.135||0.013|TWO_SIDED|95.0|-9.52|-1.13||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.13|-9.52|0.013
71115284|NCT01942668|141737528|SUPERIORITY||Mean Difference (Final Values)|-5.76|STANDARD_ERROR_OF_MEAN|2.08||0.006|TWO_SIDED|95.0|-9.85|-1.68||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.68|-9.85|0.006
71115285|NCT01942668|141737528|SUPERIORITY||Mean Difference (Final Values)|-5.59|STANDARD_ERROR_OF_MEAN|2.132||0.009|TWO_SIDED|95.0|-9.77|-1.4||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.40|-9.77|0.009
71115286|NCT01942668|141737528|SUPERIORITY||Mean Difference (Final Values)|-5.68|STANDARD_ERROR_OF_MEAN|2.093||0.007|TWO_SIDED|95.0|-9.79|-1.57||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.57|-9.79|0.007
71115287|NCT01942668|141737529|SUPERIORITY||Mean Difference (Final Values)|-3.39|STANDARD_ERROR_OF_MEAN|2.47||0.171|TWO_SIDED|95.0|-8.24|1.47||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||1.47|-8.24|0.171
71073160|NCT00772005|141655766|SUPERIORITY_OR_OTHER|||||||0.2538||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2538
71073161|NCT00772005|141655766|SUPERIORITY_OR_OTHER|||||||0.3406||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3406
71073162|NCT00772005|141655767|SUPERIORITY_OR_OTHER|||||||0.8116||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8116
71073163|NCT00772005|141655767|SUPERIORITY_OR_OTHER|||||||0.687||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6870
71073164|NCT00772005|141655767|SUPERIORITY_OR_OTHER|||||||0.8112||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8112
71073165|NCT00772005|141655768|SUPERIORITY_OR_OTHER|||||||0.9786||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9786
71073166|NCT00772005|141655768|SUPERIORITY_OR_OTHER|||||||0.5879||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5879
71073167|NCT00772005|141655768|SUPERIORITY_OR_OTHER|||||||0.3973||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3973
71073168|NCT00772005|141655769|SUPERIORITY_OR_OTHER|||||||0.403||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4030
71073169|NCT00772005|141655769|SUPERIORITY_OR_OTHER|||||||0.3777||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3777
71073170|NCT00772005|141655769|SUPERIORITY_OR_OTHER|||||||0.6493||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6493
71073171|NCT00772005|141655770|SUPERIORITY_OR_OTHER|||||||0.9871||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9871
71073172|NCT00772005|141655770|SUPERIORITY_OR_OTHER|||||||0.5859||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5859
71073173|NCT00772005|141655770|SUPERIORITY_OR_OTHER|||||||0.0328||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0328
71115288|NCT01942668|141737529|SUPERIORITY||Mean Difference (Final Values)|-6.49|STANDARD_ERROR_OF_MEAN|2.364||0.006|TWO_SIDED|95.0|-11.14|-1.85||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-1.85|-11.14|0.006
71073174|NCT00772005|141655771|SUPERIORITY_OR_OTHER|||||||0.2318||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2318
71073175|NCT00772005|141655771|SUPERIORITY_OR_OTHER|||||||0.6211||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6211
71073176|NCT00772005|141655771|SUPERIORITY_OR_OTHER|||||||0.3125||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3125
71073177|NCT00772005|141655772|SUPERIORITY_OR_OTHER|||||||0.2425||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2425
71073178|NCT00772005|141655772|SUPERIORITY_OR_OTHER|||||||0.6597||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6597
71073179|NCT00772005|141655772|SUPERIORITY_OR_OTHER|||||||0.4753||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4753
71073180|NCT00772005|141655773|SUPERIORITY_OR_OTHER|||||||0.1715||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1715
71073181|NCT00772005|141655773|SUPERIORITY_OR_OTHER|||||||0.3056||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3056
71073182|NCT00772005|141655773|SUPERIORITY_OR_OTHER|||||||0.0083||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0083
71073183|NCT00772005|141655774|SUPERIORITY_OR_OTHER|||||||0.2681||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2681
71073184|NCT00772005|141655774|SUPERIORITY_OR_OTHER|||||||0.1475||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1475
71073185|NCT00772005|141655774|SUPERIORITY_OR_OTHER|||||||0.0647||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0647
71073186|NCT00772005|141655775|SUPERIORITY_OR_OTHER|||||||0.167||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1670
70940327|NCT00141271|141380801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8276||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.8276
71073187|NCT00772005|141655775|SUPERIORITY_OR_OTHER|||||||0.1737||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1737
71073188|NCT00772005|141655775|SUPERIORITY_OR_OTHER|||||||0.372||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3720
71073189|NCT00772005|141655776|SUPERIORITY_OR_OTHER|||||||0.3547||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3547
71073190|NCT00772005|141655776|SUPERIORITY_OR_OTHER|||||||0.6043||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6043
71073191|NCT00772005|141655776|SUPERIORITY_OR_OTHER|||||||0.0463||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0463
71115289|NCT01942668|141737529|SUPERIORITY||Mean Difference (Final Values)|-7.39|STANDARD_ERROR_OF_MEAN|2.434||0.003|TWO_SIDED|95.0|-12.17|-2.61||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.61|-12.17|0.003
71115290|NCT01942668|141737529|SUPERIORITY||Mean Difference (Final Values)|-6.69|STANDARD_ERROR_OF_MEAN|2.429||0.006|TWO_SIDED|95.0|-11.46|-1.92||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-1.92|-11.46|0.006
71115291|NCT01942668|141737530|SUPERIORITY||Mean Difference (Final Values)|-4.21|STANDARD_ERROR_OF_MEAN|2.037||0.039|TWO_SIDED|95.0|-8.21|-0.21||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.21|-8.21|0.039
70940328|NCT00141271|141380801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8502||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.8502
71073192|NCT00772005|141655777|SUPERIORITY_OR_OTHER|||||||0.9258||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9258
71073193|NCT00772005|141655777|SUPERIORITY_OR_OTHER|||||||0.9116||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9116
71073194|NCT00772005|141655777|SUPERIORITY_OR_OTHER|||||||0.4848||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4848
71073195|NCT00772005|141655778|SUPERIORITY_OR_OTHER|||||||0.7612||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7612
71073196|NCT00772005|141655778|SUPERIORITY_OR_OTHER|||||||0.5761||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5761
71073197|NCT00772005|141655778|SUPERIORITY_OR_OTHER|||||||0.1576||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1576
71073198|NCT00772005|141655779|SUPERIORITY_OR_OTHER|||||||0.9565||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9565
70940329|NCT00141271|141380801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6343||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.6343
70940330|NCT00141271|141380801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3082||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.3082
71073199|NCT00772005|141655779|SUPERIORITY_OR_OTHER|||||||0.9178||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9178
71073200|NCT00772005|141655779|SUPERIORITY_OR_OTHER|||||||0.1491||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1491
71073201|NCT00772005|141655780|SUPERIORITY_OR_OTHER|||||||0.7056||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7056
71073202|NCT00772005|141655780|SUPERIORITY_OR_OTHER|||||||0.5179||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5179
71073203|NCT00772005|141655780|SUPERIORITY_OR_OTHER|||||||0.4585||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4585
71073204|NCT00772005|141655781|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0690
71073205|NCT00772005|141655781|SUPERIORITY_OR_OTHER|||||||0.5324||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5324
71073206|NCT00772005|141655781|SUPERIORITY_OR_OTHER|||||||0.0946||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0946
70853438|NCT02270944|141195004|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To assess the vaccine formulations equivalence, the lower limit of the two-sided 95% confidence interval (CI) for the ratio of GMCs at Day 31 after vaccination must be \> 0.5 and the upper limit of the two-sided 95% CI must be \< 2.0 (the entire two-sided 95% CI must be contained in the 0.5, 2.0 interval).|Ratio of GMCs|1.02|||||TWO_SIDED|95.0|0.79|1.32|||ANCOVA|Analysis of covariance (ANCOVA) model with vaccine group and center as fixed effects and log10-prevaccination antibody concentration as a covariate||To demonstrate the equivalence of the liquid GBS trivalent vaccine formulation to the lyophilized GBS trivalent vaccine formulation for serotypes Ia when administered to healthy non-pregnant women, as measured by geometric mean concentrations (GMC).||1.32|0.79|
71073207|NCT00772005|141655782|SUPERIORITY_OR_OTHER|||||||0.1878||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1878
71073208|NCT00772005|141655782|SUPERIORITY_OR_OTHER|||||||0.4294||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4294
71073209|NCT00772005|141655782|SUPERIORITY_OR_OTHER|||||||0.6504||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6504
71073210|NCT00772005|141655783|SUPERIORITY_OR_OTHER|||||||0.4022||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4022
71073211|NCT00772005|141655783|SUPERIORITY_OR_OTHER|||||||0.6246||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6246
71073212|NCT00772005|141655783|SUPERIORITY_OR_OTHER|||||||0.8655||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8655
71073213|NCT00772005|141655784|SUPERIORITY_OR_OTHER|||||||0.5676||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5676
71073214|NCT00772005|141655784|SUPERIORITY_OR_OTHER|||||||0.5239||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5239
71073215|NCT00772005|141655784|SUPERIORITY_OR_OTHER|||||||0.4092||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4092
71073216|NCT00772005|141655785|SUPERIORITY_OR_OTHER|||||||0.5195||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5195
71073217|NCT00772005|141655785|SUPERIORITY_OR_OTHER|||||||0.1732||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1732
71073218|NCT00772005|141655785|SUPERIORITY_OR_OTHER|||||||0.7455||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7455
71073219|NCT00772005|141655786|SUPERIORITY_OR_OTHER|||||||0.6885||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6885
71073220|NCT00772005|141655786|SUPERIORITY_OR_OTHER|||||||0.5443||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5443
71073221|NCT00772005|141655786|SUPERIORITY_OR_OTHER|||||||0.9343||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9343
71073222|NCT00772005|141655787|SUPERIORITY_OR_OTHER|||||||0.9093||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9093
71073223|NCT00772005|141655787|SUPERIORITY_OR_OTHER|||||||0.4701||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4701
71073224|NCT00772005|141655787|SUPERIORITY_OR_OTHER|||||||0.9764||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9764
71073225|NCT00772005|141655788|SUPERIORITY_OR_OTHER|||||||0.8115||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8115
71073226|NCT00772005|141655788|SUPERIORITY_OR_OTHER|||||||0.5378||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5378
71073227|NCT00772005|141655788|SUPERIORITY_OR_OTHER|||||||0.9144||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9144
71073228|NCT00772005|141655789|SUPERIORITY_OR_OTHER|||||||0.9812||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9812
71073229|NCT00772005|141655789|SUPERIORITY_OR_OTHER|||||||0.5464||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5464
71073230|NCT00772005|141655789|SUPERIORITY_OR_OTHER|||||||0.8811||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8811
71073231|NCT00772005|141655790|SUPERIORITY_OR_OTHER|||||||0.6487||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6487
71073232|NCT00772005|141655790|SUPERIORITY_OR_OTHER|||||||0.4204||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4204
71073233|NCT00772005|141655790|SUPERIORITY_OR_OTHER|||||||0.6955||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6955
71073234|NCT00772005|141655791|SUPERIORITY_OR_OTHER|||||||0.6042||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6042
71073235|NCT00772005|141655791|SUPERIORITY_OR_OTHER|||||||0.9783||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9783
71073236|NCT00772005|141655791|SUPERIORITY_OR_OTHER|||||||0.9739||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9739
71073237|NCT00772005|141655792|SUPERIORITY_OR_OTHER|||||||0.3466||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3466
71115292|NCT01942668|141737530|SUPERIORITY||Mean Difference (Final Values)|-2.39|STANDARD_ERROR_OF_MEAN|1.997||0.232|TWO_SIDED|95.0|-6.31|1.53||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||1.53|-6.31|0.232
71115293|NCT01942668|141737530|SUPERIORITY||Mean Difference (Final Values)|-4.37|STANDARD_ERROR_OF_MEAN|2.012||0.03|TWO_SIDED|95.0|-8.32|-0.42||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.42|-8.32|0.030
71073238|NCT00772005|141655792|SUPERIORITY_OR_OTHER|||||||0.8469||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8469
71115294|NCT01942668|141737530|SUPERIORITY||Mean Difference (Final Values)|-2.22|STANDARD_ERROR_OF_MEAN|1.973||0.262|TWO_SIDED|95.0|-6.09|1.66||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||1.66|-6.09|0.262
71073239|NCT00772005|141655792|SUPERIORITY_OR_OTHER|||||||0.5439||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5439
71073240|NCT00772005|141655793|SUPERIORITY_OR_OTHER|||||||0.6059||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6059
71073241|NCT00772005|141655793|SUPERIORITY_OR_OTHER|||||||0.7474||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7474
71073242|NCT00772005|141655793|SUPERIORITY_OR_OTHER|||||||0.4424||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4424
71073243|NCT00772005|141655794|SUPERIORITY_OR_OTHER|||||||0.4874||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4874
71073244|NCT00772005|141655794|SUPERIORITY_OR_OTHER|||||||0.8243||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8243
71073245|NCT00772005|141655794|SUPERIORITY_OR_OTHER|||||||0.9562||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9562
71073246|NCT00772005|141655795|SUPERIORITY_OR_OTHER|||||||0.3686||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3686
71073247|NCT00772005|141655795|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0270
71073248|NCT00772005|141655795|SUPERIORITY_OR_OTHER|||||||0.7322||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7322
71073249|NCT00772005|141655796|SUPERIORITY_OR_OTHER|||||||0.4646||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4646
71073250|NCT00772005|141655796|SUPERIORITY_OR_OTHER|||||||0.8783||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8783
71073251|NCT00772005|141655796|SUPERIORITY_OR_OTHER|||||||0.4213||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4213
71073252|NCT00772005|141655797|SUPERIORITY_OR_OTHER|||||||0.6597||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6597
71073253|NCT00772005|141655797|SUPERIORITY_OR_OTHER|||||||0.0262||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0262
71073254|NCT00772005|141655797|SUPERIORITY_OR_OTHER|||||||0.6652||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6652
71073255|NCT00772005|141655798|SUPERIORITY_OR_OTHER|||||||0.3355||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3355
71073256|NCT00772005|141655798|SUPERIORITY_OR_OTHER|||||||0.0953||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0953
71073257|NCT00772005|141655798|SUPERIORITY_OR_OTHER|||||||0.9235||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9235
71073258|NCT00772005|141655799|SUPERIORITY_OR_OTHER|||||||0.4164||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4164
71073259|NCT00772005|141655799|SUPERIORITY_OR_OTHER|||||||0.3003||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3003
71073260|NCT00772005|141655799|SUPERIORITY_OR_OTHER|||||||0.6907||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6907
71073261|NCT00772005|141655800|SUPERIORITY_OR_OTHER|||||||0.2518||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2518
71073262|NCT00772005|141655800|SUPERIORITY_OR_OTHER|||||||0.0739||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0739
71073263|NCT00772005|141655800|SUPERIORITY_OR_OTHER|||||||0.5644||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5644
71115295|NCT01942668|141737531|SUPERIORITY||Mean Difference (Final Values)|-5.41|STANDARD_ERROR_OF_MEAN|2.119||0.011|TWO_SIDED|95.0|-9.57|-1.25||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.25|-9.57|0.011
71073264|NCT00772005|141655801|SUPERIORITY_OR_OTHER|||||||0.4305||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4305
71073265|NCT00772005|141655801|SUPERIORITY_OR_OTHER|||||||0.8299||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8299
71073266|NCT00772005|141655801|SUPERIORITY_OR_OTHER|||||||0.7283||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7283
71115296|NCT01942668|141737531|SUPERIORITY||Mean Difference (Final Values)|-5.54|STANDARD_ERROR_OF_MEAN|2.065||0.008|TWO_SIDED|95.0|-9.6|-1.48||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.48|-9.60|0.008
71115297|NCT01942668|141737531|SUPERIORITY||Mean Difference (Final Values)|-5.74|STANDARD_ERROR_OF_MEAN|2.115||0.007|TWO_SIDED|95.0|-9.9|-1.59||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.59|-9.90|0.007
71115298|NCT01942668|141737531|SUPERIORITY||Mean Difference (Final Values)|-5.32|STANDARD_ERROR_OF_MEAN|2.078||0.011|TWO_SIDED|95.0|-9.4|-1.24||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.24|-9.40|0.011
71115299|NCT01942668|141737532|SUPERIORITY||Mean Difference (Final Values)|-4.21|STANDARD_ERROR_OF_MEAN|2.421||0.083|TWO_SIDED|95.0|-8.96|0.55||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.55|-8.96|0.083
71073267|NCT00772005|141655802|SUPERIORITY_OR_OTHER|||||||0.761||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7610
71073268|NCT00772005|141655802|SUPERIORITY_OR_OTHER|||||||0.6091||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6091
71073269|NCT00772005|141655802|SUPERIORITY_OR_OTHER|||||||0.3368||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3368
71073270|NCT00772005|141655803|SUPERIORITY_OR_OTHER|||||||0.8457||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8457
71073271|NCT00772005|141655803|SUPERIORITY_OR_OTHER|||||||0.4531||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4531
71073272|NCT00772005|141655803|SUPERIORITY_OR_OTHER|||||||0.6867||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6867
71073273|NCT00772005|141655804|SUPERIORITY_OR_OTHER|||||||0.9705||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9705
71073274|NCT00772005|141655804|SUPERIORITY_OR_OTHER|||||||0.0021||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0021
71073275|NCT00772005|141655804|SUPERIORITY_OR_OTHER|||||||0.5013||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5013
70940331|NCT00141271|141380802|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6932||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.6932
71073276|NCT00772005|141655805|SUPERIORITY_OR_OTHER|||||||0.733||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7330
71073277|NCT00772005|141655805|SUPERIORITY_OR_OTHER|||||||0.0068||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0068
71073278|NCT00772005|141655805|SUPERIORITY_OR_OTHER|||||||0.104||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1040
71073279|NCT00772005|141655806|SUPERIORITY_OR_OTHER|||||||0.822||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8220
71073280|NCT00772005|141655806|SUPERIORITY_OR_OTHER|||||||0.0144||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0144
70940332|NCT00141271|141380802|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0287||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.0287
71115300|NCT01942668|141737532|SUPERIORITY||Mean Difference (Final Values)|-7.36|STANDARD_ERROR_OF_MEAN|2.317||0.002|TWO_SIDED|95.0|-11.91|-2.81||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.81|-11.91|0.002
71115301|NCT01942668|141737532|SUPERIORITY||Mean Difference (Final Values)|-7.92|STANDARD_ERROR_OF_MEAN|2.384|<|0.001|TWO_SIDED|95.0|-12.6|-3.23||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.23|-12.60|<0.001
71115302|NCT01942668|141737532|SUPERIORITY||Mean Difference (Final Values)|-6.78|STANDARD_ERROR_OF_MEAN|2.381||0.005|TWO_SIDED|95.0|-11.46|-2.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.10|-11.46|0.005
71115303|NCT01942668|141737533|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.938|TWO_SIDED|95.0|-0.12|0.11||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.11|-0.12|0.938
71115304|NCT01942668|141737533|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.059||0.779|TWO_SIDED|95.0|-0.1|0.13||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.13|-0.10|0.779
71115305|NCT01942668|141737533|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.059||0.646|TWO_SIDED|95.0|-0.14|0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.09|-0.14|0.646
71073281|NCT00772005|141655806|SUPERIORITY_OR_OTHER|||||||0.9464||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9464
71073282|NCT03280225|141655866|OTHER||Odds Ratio (OR)|1.43||||0.302|TWO_SIDED|95.0|0.73|2.82|||Regression, Logistic||Odds ratios were estimated using GEE to control for clustering within VAMCs. Fixed effects included a time-dependent variable (pre-post) as well an independent variable of time to account for improvement due to secular trends.|Odds Ratio of eligible Veterans being assigned a coordinator during the 6 month period following implementation compared to eligible Veterans being assigned a coordinator in the 6 month period prior to implementation.||2.82|0.73|.302
71073283|NCT03280225|141655867|OTHER||Odds Ratio (OR)|1.29||||0.226|TWO_SIDED|95.0|0.86|1.93|||Regression, Logistic||Odds ratios were estimated using GEE to control for clustering within VAMCs. Fixed effects included a time-dependent variable (pre-post) as well an independent variable of time to account for improvement due to secular trends.|Odds Ratio of eligible Veterans being assigned a provider during the 6 month period following implementation compared to eligible Veterans being assigned a provider in the 6 month period prior to implementation.||1.93|0.86|0.226
71073284|NCT03280225|141655868|OTHER||Odds Ratio (OR)|1.23||||0.199|TWO_SIDED|95.0|0.9|1.7|||Regression, Logistic||Odds ratios were estimated using GEE to control for clustering within VAMCs. Fixed effects included a time-dependent variable (pre-post) as well an independent variable of time to account for improvement due to secular trends.|Odds Ratio of eligible Veterans receiving a care evaluation during the 6 month period following implementation compared to eligible Veterans receiving a care evaluation in the 6 month period prior to implementation.||1.70|0.90|0.199
71073285|NCT03280225|141655869|OTHER||Odds Ratio (OR)|1.38||||0.011|TWO_SIDED|95.0|1.08|1.76|||Regression, Logistic||Odds ratios were estimated using GEE to control for clustering within VAMCs. Fixed effects included a time-dependent variable (pre-post) as well an independent variable of time to account for improvement due to secular trends.|Odds Ratio of eligible Veterans where outreach was attempted during the 6 month period following implementation compared to eligible Veterans where outreach was attempted in the 6 month period prior to implementation.||1.76|1.08|0.011
71073286|NCT03280225|141655870|SUPERIORITY|||||||0.018|||||||ANOVA|F (4, 158) = 3.08||Program Needs||||.018
71073287|NCT03280225|141655870|SUPERIORITY|||||||0.136|||||||ANOVA|F (4, 158) = 1.78||Training Needs||||.136
71073288|NCT03280225|141655870|SUPERIORITY|Pressure for Change||||||0.812|||||||ANOVA|F (4, 158) = 0.39||||||.812
71073289|NCT03280225|141655870|SUPERIORITY|Staffing||||||0.358|||||||ANOVA|F (4, 158) = 1.10||||||.358
70940333|NCT00141271|141380802|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2128||95.0||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.2128
71073290|NCT03280225|141655870|SUPERIORITY|Mission||||||0.748|||||||ANOVA|F (4, 158) = 0.48||||||.748
71073291|NCT03280225|141655870|SUPERIORITY|||||||0.748|||||||ANOVA|F (4, 158) = 0.48||Cohesion||||.748
71073292|NCT03280225|141655870|SUPERIORITY|||||||0.005|||||||ANOVA|F (4, 158) = 3.88||Autonomy||||.005
71073293|NCT03280225|141655870|SUPERIORITY|||||||0.224|||||||ANOVA|F (4, 158) = 1.44||Communication||||.224
71073294|NCT03280225|141655870|SUPERIORITY|||||||0.043|||||||ANOVA|F (4, 158) = 2.52||Stress||||.043
71073295|NCT03280225|141655870|SUPERIORITY|||||||0.096|||||||ANOVA|F (4, 158) = 2.01||Change||||.096
70940334|NCT00141271|141380802|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1118||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.1118
71073296|NCT01606202|141655873|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.08||||0.708|TWO_SIDED|95.0|-0.51|0.35|||ANCOVA|||The change in the pain Numerical Rating Scale score from baseline to End of Treatment was compared between treatment groups using analysis of covariance (ANCOVA). The model included treatment and centre as factors and baseline Numerical Rating Scale pain mean score as a covariate.||0.35|-0.51|0.708
71073297|NCT01606202|141655874|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.57||||0.852|TWO_SIDED|95.0|-6.62|5.48|||ANCOVA|||The change from baseline to End of Treatment in the percentage of days on which escape medication was used was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and percentage of days on which escape medication was used as a covariate.||5.48|-6.62|0.852
71073298|NCT01606202|141655875|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.05||||0.86|TWO_SIDED|95.0|-0.54|0.65|||ANCOVA|||The change from baseline to End of Treatment in the Spasm severity Numerical Rating Scale score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the Spasm severity Numerical Rating Scale score as a covariate.||0.65|-0.54|0.860
71073299|NCT01606202|141655876|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.64||||0.873|TWO_SIDED|95.0|-8.56|7.27|||ANCOVA|||The change from baseline to End of Treatment in the percentage of days on which spasm was experienced was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the Spasm percentage of days on which spasm was experienced as a covariate.||7.27|-8.56|0.873
71115306|NCT01942668|141737533|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.058||0.421|TWO_SIDED|95.0|-0.07|0.16||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.16|-0.07|0.421
71115307|NCT01942668|141737534|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.063||0.075|TWO_SIDED|95.0|-0.01|0.24||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.24|-0.01|0.075
71115308|NCT01942668|141737534|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.062||0.074|TWO_SIDED|95.0|-0.01|0.23||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.23|-0.01|0.074
71115309|NCT01942668|141737534|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.063||0.37|TWO_SIDED|95.0|-0.07|0.18||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.18|-0.07|0.370
71073300|NCT01606202|141655877|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.07||||0.83|TWO_SIDED|95.0|-0.61|0.75|||ANCOVA|||The change from baseline to End of Treatment in the spasticity severity Numerical Rating Scale score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the baseline spasticity severity Numerical Rating Scale score as a covariate.||0.75|-0.61|0.830
71073301|NCT01606202|141655878|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.4||||0.86|TWO_SIDED|95.0|-4.08|4.88|||ANCOVA|||The change from baseline to End of Treatment in the percentage of days on which spasticity was experienced was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the percentage of days on which spasticity was experienced as a covariate.||4.88|-4.08|0.860
71073302|NCT01606202|141655879|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.14||||0.142|TWO_SIDED|95.0|-0.33|0.05|||ANCOVA|||The change from baseline to End of Treatment in the Modified Ashworth scale score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the Modified Ashworth scale score as a covariate.||0.05|-0.33|0.142
71073303|NCT01606202|141655880|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.11||||0.824|TWO_SIDED|95.0|-1.13|0.9|||ANCOVA|||The change from baseline in the mean Short Orientation Memory Concentration score, was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Short Orientation Memory Concentration test score as a covariate.||0.90|-1.13|0.824
71073304|NCT01606202|141655881|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.04||||0.847|TWO_SIDED|95.0|-0.49|0.4|||ANCOVA|||The change from baseline to End of Treatment in the Spitzer Quality of Life Index score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the Spitzer Quality of Life Index score as a covariate.||0.40|-0.49|0.847
71073305|NCT01606202|141655882|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.29||||0.287|TWO_SIDED|95.0|-3.74|1.16|||ANCOVA|||The change from baseline to End of Treatment in the Caregiver Strain Index score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the baseline Caregiver Strain Index score as a covariate.||1.16|-3.74|0.287
71073306|NCT01606202|141655883|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|33.86|||<|0.001|TWO_SIDED|95.0|17.07|50.64|||Fisher Exact|||The proportion of subjects who considered their condition 'Very Much Improved', 'Much Improved' or 'Minimally Improved' was compared between treatment groups using Fisher's Exact Test.||50.64|17.07|<0.001
71073307|NCT01606202|141655884|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.93||||0.032|TWO_SIDED|95.0|-3.69|-0.16|||ANCOVA|||The change from baseline to End of Treatment in the Brief Pain Inventory score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Brief Pain Inventory score as a covariate.||-0.16|-3.69|0.032
71073308|NCT01267201|141655887|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|92.11|||||TWO_SIDED|90.0|88.23|96.15||||||Natural log transformed AUC (0 - ∞) of methylprednisolone was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||96.15|88.23|
71073309|NCT01267201|141655887|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|90.22|||||TWO_SIDED|90.0|86.49|94.11||||||Natural log transformed AUC (0 - ∞) of methylprednisolone was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||94.11|86.49|
71073310|NCT01267201|141655888|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|94.76|||||TWO_SIDED|90.0|88.06|101.98||||||Natural log transformed Cmax of methylprednisolone was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||101.98|88.06|
71073311|NCT01267201|141655888|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|83.89|||||TWO_SIDED|90.0|78.06|90.17||||||Natural log transformed Cmax of methylprednisolone was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||90.17|78.06|
71073312|NCT02719938|141655896|SUPERIORITY|||||||0.415|||||||t-test, 2 sided|||||||0.415
71073313|NCT02719938|141655897|SUPERIORITY|||||||0.521|||||||t-test, 2 sided|||||||0.521
71073314|NCT02719938|141655898|SUPERIORITY|||||||0.409|||||||t-test, 2 sided|||||||0.409
71115310|NCT01942668|141737534|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.062||0.851|TWO_SIDED|95.0|-0.11|0.13||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.13|-0.11|0.851
70940335|NCT00141271|141380802|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6144||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.6144
71073315|NCT02719938|141655899|SUPERIORITY|||||||0.019|||||||Chi-squared|||||||0.019
71073316|NCT02719938|141655900|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71073317|NCT02719938|141655901|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71073318|NCT02719938|141655902|SUPERIORITY|||||||0.516|||||||t-test, 2 sided|||||||0.516
71073319|NCT00955968|141655903|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.54|TWO_SIDED|95.0|0.19|2.4||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART|||2.40|0.19|0.54
71073320|NCT00955968|141655904|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.66|TWO_SIDED|95.0|0.11|4.01||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART|||4.01|0.11|0.66
71073321|NCT00955968|141655906|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.44|TWO_SIDED|95.0|0.09|2.81||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART|||2.81|0.09|0.44
71073322|NCT00955968|141655907|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.79|TWO_SIDED|95.0|0.54|1.6||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART|||1.60|0.54|0.79
71073323|NCT00955968|141655908|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.71|TWO_SIDED|95.0|0.54|1.52||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART|||1.52|0.54|0.71
71073324|NCT00955968|141655909|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.42|0.8||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART|||0.80|0.42|<0.001
71073325|NCT00955968|141655910|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.1|TWO_SIDED|95.0|0.72|1.03||5% alpha level and 2-sided test|Log Rank|||||1.03|0.72|0.10
71073326|NCT02923245|141655952|OTHER||Mean Difference (Final Values)|49.7|||||TWO_SIDED|95.0|23.4|77.2|||||These confidence intervals correspond to the bootstrap analysis|||77.2|23.4|
71073327|NCT02923245|141655953|OTHER||Difference in percentages|15.3||||0.006|TWO_SIDED|95.0|5.3|25.0|||Test of proportions|||||25.0|5.3|0.006
71073328|NCT00793624|141655984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.11|0.193|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.193|0.110|<0.0001
71073329|NCT00793624|141655984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.124|0.206|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.206|0.124|<0.0001
71073330|NCT00793624|141655984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.177|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.136|0.218|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.218|0.136|<0.0001
71073331|NCT00793624|141655985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|STANDARD_ERROR_OF_MEAN|0.021||0.0002||95.0|0.037|0.118|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.118|0.037|0.0002
71073332|NCT00793624|141655985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.044|0.125|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.125|0.044|<0.0001
71073333|NCT00793624|141655985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.021||0.0088||95.0|0.014|0.095|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.095|0.014|0.0088
71073334|NCT00793624|141655986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|STANDARD_ERROR_OF_MEAN|0.343||0.5843||95.0|-0.485|0.86|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.860|-0.485|0.5843
71073335|NCT00793624|141655986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.345||0.9494||95.0|-0.656|0.699|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.699|-0.656|0.9494
71073336|NCT00793624|141655986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.288|STANDARD_ERROR_OF_MEAN|0.346||0.5099||95.0|-0.908|0.451|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.451|-0.908|0.5099
71073337|NCT00793624|141655987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.442|STANDARD_ERROR_OF_MEAN|1.401||0.0816||95.0|-5.19|0.307|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.307|-5.190|0.0816
71073338|NCT00793624|141655987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.394|STANDARD_ERROR_OF_MEAN|1.4||0.0155||95.0|-6.141|-0.648|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.648|-6.141|0.0155
71115311|NCT01942668|141737535|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.067||0.452|TWO_SIDED|95.0|-0.18|0.08||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.08|-0.18|0.452
70940336|NCT00141271|141380802|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0899||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.0899
70853439|NCT02270944|141195005|NON_INFERIORITY|To assess the vaccine formulations equivalence, the lower limit of the two-sided 95% confidence interval (CI) for the ratio of GMCs at Day 31 after vaccination must be \> 0.5 and the upper limit of the two-sided 95% CI must be \< 2.0 (the entire two-sided 95% CI must be contained in the 0.5, 2.0 interval).|Ratio of GMCs|0.99|||||TWO_SIDED|95.0|0.76|1.3|||ANCOVA|Analysis of covariance (ANCOVA) model with vaccine group and center as fixed effects and log10-prevaccination antibody concentration as a covariate||to demonstrate the equivalence of the liquid GBS trivalent vaccine formulation to the lyophilized GBS trivalent vaccine formulation for serotypes III when administered to healthy non-pregnant women, as measured by geometric mean concentrations (GMC).||1.30|0.76|
71073339|NCT00793624|141655987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.952|STANDARD_ERROR_OF_MEAN|1.396||0.4954||95.0|-3.691|1.787|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.787|-3.691|0.4954
71073340|NCT00793624|141655988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.785|STANDARD_ERROR_OF_MEAN|1.387||0.045||95.0|-5.507|-0.063|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.063|-5.507|0.0450
71073341|NCT00793624|141655988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.144|STANDARD_ERROR_OF_MEAN|1.386||0.0002||95.0|-7.864|-2.425|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||-2.425|-7.864|0.0002
71073342|NCT00793624|141655988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.754|STANDARD_ERROR_OF_MEAN|1.386||0.2061||95.0|-4.474|0.966|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.966|-4.474|0.2061
71073343|NCT00793624|141655989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.871|STANDARD_ERROR_OF_MEAN|1.419||0.1878||95.0|-4.655|0.914|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.914|-4.655|0.1878
71073344|NCT00793624|141655989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.565|STANDARD_ERROR_OF_MEAN|1.427||0.0126||95.0|-6.364|-0.767|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.767|-6.364|0.0126
71073345|NCT00793624|141655989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|1.426||0.9913||95.0|-2.782|2.814|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||2.814|-2.782|0.9913
71073346|NCT00793624|141655990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.846|STANDARD_ERROR_OF_MEAN|0.972||0.0034||95.0|-4.751|-0.94|||Mixed Models Analysis||Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||-0.940|-4.751|0.0034
71073347|NCT00793624|141655990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.434|STANDARD_ERROR_OF_MEAN|0.973||0.0004||95.0|-5.343|-1.525|||Mixed Models Analysis||Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||-1.525|-5.343|0.0004
71073348|NCT00793624|141655990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.248|STANDARD_ERROR_OF_MEAN|0.976||0.2009||95.0|-3.161|0.665|||Mixed Models Analysis||Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 10 mcg qd minus Placebo||0.665|-3.161|0.2009
71073349|NCT00793624|141655991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.146|0.226|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.226|0.146|<0.0001
71073350|NCT00793624|141655991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.126|0.206|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.206|0.126|<0.0001
71073351|NCT00793624|141655991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.166|0.246|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.246|0.166|<0.0001
71073352|NCT00793624|141655992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.136|0.217|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.217|0.136|<0.0001
71073353|NCT00793624|141655992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.119|0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.200|0.119|<0.0001
71073354|NCT00793624|141655992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.152|0.233|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.233|0.152|<0.0001
71073355|NCT00793624|141655993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.137|0.219|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.219|0.137|<0.0001
71073356|NCT00793624|141655993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.129|0.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.211|0.129|<0.0001
71073357|NCT00793624|141655993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.144|0.226|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.226|0.144|<0.0001
71115312|NCT01942668|141737535|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.064||0.244|TWO_SIDED|95.0|-0.05|0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.20|-0.05|0.244
71115313|NCT01942668|141737535|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.065||0.354|TWO_SIDED|95.0|-0.19|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.07|-0.19|0.354
71115314|NCT01942668|141737535|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.065||0.527|TWO_SIDED|95.0|-0.17|0.09||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.09|-0.17|0.527
71073358|NCT00793624|141655994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.103|0.186|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.186|0.103|<0.0001
71115315|NCT01942668|141737536|SUPERIORITY||Mean Difference (Final Values)|-1.92|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-2.29|-1.55||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.55|-2.29|<0.001
71115316|NCT01942668|141737536|SUPERIORITY||Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|0.189|<|0.001|TWO_SIDED|95.0|-1.81|-1.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.07|-1.81|<0.001
71115317|NCT01942668|141737536|SUPERIORITY||Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|0.189|<|0.001|TWO_SIDED|95.0|-1.81|-1.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.07|-1.81|<0.001
70940337|NCT00141271|141380802|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8819||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.8819
70940338|NCT00141271|141380802|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8374||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.8374
71073359|NCT00793624|141655994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.146|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.105|0.188|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.188|0.105|<0.0001
71073360|NCT00793624|141655994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.13|0.214|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.214|0.130|<0.0001
71073361|NCT00793624|141655995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.048|0.126|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.126|0.048|<0.0001
71073362|NCT00793624|141655995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.04|0.118|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.118|0.040|<0.0001
71073363|NCT00793624|141655995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.04|0.119|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.119|0.040|<0.0001
71073364|NCT00793624|141655996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.047|0.125|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.125|0.047|<0.0001
71073365|NCT00793624|141655996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|STANDARD_ERROR_OF_MEAN|0.02||0.0001||95.0|0.038|0.117|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.117|0.038|0.0001
71073366|NCT00793624|141655996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.039|0.119|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.119|0.039|<0.0001
71073367|NCT00793624|141655997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.083|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.043|0.123|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.123|0.043|<0.0001
71073368|NCT00793624|141655997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|0.02||0.0002||95.0|0.035|0.114|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.114|0.035|0.0002
71073369|NCT00793624|141655997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.02||0.0037||95.0|0.019|0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.100|0.019|0.0037
71073370|NCT00793624|141655998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.02||0.0016||95.0|0.025|0.105|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.105|0.025|0.0016
71115318|NCT01942668|141737536|SUPERIORITY||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.188|<|0.001|TWO_SIDED|95.0|-1.62|-0.88||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.88|-1.62|<0.001
71115319|NCT01942668|141737537|SUPERIORITY||Mean Difference (Final Values)|-1.73|STANDARD_ERROR_OF_MEAN|0.199|<|0.001|TWO_SIDED|95.0|-2.12|-1.34||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.34|-2.12|<0.001
71115320|NCT01942668|141737537|SUPERIORITY||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|0.197|<|0.001|TWO_SIDED|95.0|-1.68|-0.91||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.91|-1.68|<0.001
71115321|NCT01942668|141737537|SUPERIORITY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.197|<|0.001|TWO_SIDED|95.0|-1.58|-0.81||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.81|-1.58|<0.001
71073371|NCT00793624|141655998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.02||0.0276||95.0|0.005|0.085|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.085|0.005|0.0276
70940339|NCT00141271|141380802|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3925||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.3925
70940340|NCT00141271|141380802|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4182||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.4182
70940341|NCT00141271|141380802|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8586||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.8586
71073372|NCT00793624|141655998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.021||0.0426||95.0|0.001|0.082|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.082|0.001|0.0426
71073373|NCT00793624|141655999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.021||0.0237||95.0|0.006|0.087|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.087|0.006|0.0237
71073374|NCT00793624|141655999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.049|STANDARD_ERROR_OF_MEAN|0.021||0.0175||95.0|0.009|0.09|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.090|0.009|0.0175
71073375|NCT00793624|141655999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.021||0.0339||95.0|0.003|0.085|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.085|0.003|0.0339
71073376|NCT00793624|141656000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.021||0.0537||95.0|-0.001|0.081|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.081|-0.001|0.0537
71073377|NCT00793624|141656000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|STANDARD_ERROR_OF_MEAN|0.021||0.0808||95.0|-0.004|0.078|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.078|-0.004|0.0808
71073378|NCT00793624|141656000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.021||0.2579||95.0|-0.017|0.065|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.065|-0.017|0.2579
71073379|NCT00793624|141656001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.021||0.0011||95.0|0.027|0.109|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.109|0.027|0.0011
71073380|NCT00793624|141656001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.021||0.0069||95.0|0.018|0.101|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.101|0.018|0.0069
71073381|NCT00793624|141656001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.04|0.119|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.119|0.040|<0.0001
71073382|NCT00793624|141656002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.177|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.135|0.22|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.220|0.135|<0.0001
71073383|NCT00793624|141656002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.108|0.193|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.193|0.108|<0.0001
71073384|NCT00793624|141656002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.148|0.233|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.233|0.148|<0.0001
71073385|NCT00793624|141656003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.124|0.209|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.209|0.124|<0.0001
71073386|NCT00793624|141656003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.109|0.195|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.195|0.109|<0.0001
71115322|NCT01942668|141737537|SUPERIORITY||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|0.198|<|0.001|TWO_SIDED|95.0|-1.34|-0.57||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.57|-1.34|<0.001
71115323|NCT01942668|141737538|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|0.207|<|0.001|TWO_SIDED|95.0|-2.06|-1.25||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-1.25|-2.06|<0.001
71115324|NCT01942668|141737538|SUPERIORITY||Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|0.204|<|0.001|TWO_SIDED|95.0|-1.87|-1.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-1.07|-1.87|<0.001
71115325|NCT01942668|141737538|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.205|<|0.001|TWO_SIDED|95.0|-1.7|-0.9||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.90|-1.70|<0.001
71115326|NCT01942668|141737538|SUPERIORITY||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|0.207|<|0.001|TWO_SIDED|95.0|-1.48|-0.67||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.67|-1.48|<0.001
71115327|NCT01942668|141737539|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.131||0.126|TWO_SIDED|95.0|-0.46|0.06||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.06|-0.46|0.126
71115328|NCT01942668|141737539|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.13||0.2|TWO_SIDED|95.0|-0.42|0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.09|-0.42|0.200
71115329|NCT01942668|141737539|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.13||0.222|TWO_SIDED|95.0|-0.41|0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.10|-0.41|0.222
71115330|NCT01942668|141737539|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.13||0.358|TWO_SIDED|95.0|-0.37|0.14||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.14|-0.37|0.358
71115331|NCT01942668|141737540|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.138||0.023|TWO_SIDED|95.0|-0.59|-0.04||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.04|-0.59|0.023
71115332|NCT01942668|141737540|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.138||0.045|TWO_SIDED|95.0|-0.55|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.01|-0.55|0.045
71115333|NCT01942668|141737540|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.137||0.384|TWO_SIDED|95.0|-0.39|0.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.15|-0.39|0.384
71115334|NCT01942668|141737540|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.138||0.424|TWO_SIDED|95.0|-0.38|0.16||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.16|-0.38|0.424
71115335|NCT01942668|141737541|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.152||0.153|TWO_SIDED|95.0|-0.52|0.08||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.08|-0.52|0.153
71115336|NCT01942668|141737541|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.151||0.058|TWO_SIDED|95.0|-0.58|0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.01|-0.58|0.058
71115337|NCT01942668|141737541|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.151||0.55|TWO_SIDED|95.0|-0.39|0.21||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.21|-0.39|0.550
70940342|NCT00141271|141380802|SUPERIORITY_OR_OTHER_LEGACY|||||||0.549||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.5490
71115338|NCT01942668|141737541|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.153||0.854|TWO_SIDED|95.0|-0.33|0.27||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.27|-0.33|0.854
71115339|NCT01942668|141737542|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.116||0.181|TWO_SIDED|95.0|-0.38|0.07||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.07|-0.38|0.181
71115340|NCT01942668|141737542|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.116||0.108|TWO_SIDED|95.0|-0.41|0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.04|-0.41|0.108
71115341|NCT01942668|141737542|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.115||0.014|TWO_SIDED|95.0|-0.51|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.06|-0.51|0.014
71115342|NCT01942668|141737542|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.115||0.323|TWO_SIDED|95.0|-0.34|0.11||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.11|-0.34|0.323
71115343|NCT01942668|141737543|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.124||0.056|TWO_SIDED|95.0|-0.48|0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.01|-0.48|0.056
70940343|NCT00141271|141380802|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6292||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.6292
70940344|NCT00141271|141380802|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1473||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.1473
70940345|NCT00141271|141380803|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2058||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.2058
70940346|NCT00141271|141380803|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9254||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.9254
71073387|NCT00793624|141656003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.139|0.226|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.226|0.139|<0.0001
71073388|NCT00793624|141656004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.122|0.208|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.208|0.122|<0.0001
71073389|NCT00793624|141656004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.116|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.203|0.116|<0.0001
71115344|NCT01942668|141737543|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.124||0.279|TWO_SIDED|95.0|-0.38|0.11||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.11|-0.38|0.279
71115345|NCT01942668|141737543|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.123||0.435|TWO_SIDED|95.0|-0.34|0.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.15|-0.34|0.435
71115346|NCT01942668|141737543|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.124||0.607|TWO_SIDED|95.0|-0.31|0.18||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.18|-0.31|0.607
71115347|NCT01942668|141737544|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.138||0.06|TWO_SIDED|95.0|-0.53|0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.01|-0.53|0.060
71115348|NCT01942668|141737544|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.137||0.026|TWO_SIDED|95.0|-0.57|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.04|-0.57|0.026
70940347|NCT00141271|141380803|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5071||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.5071
70940348|NCT00141271|141380803|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2858||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.2858
71073390|NCT00793624|141656004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.13|0.218|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.218|0.130|<0.0001
71073391|NCT00793624|141656005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.104|0.191|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.191|0.104|<0.0001
71073392|NCT00793624|141656005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.112|0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.200|0.112|<0.0001
71073393|NCT00793624|141656005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.123|0.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.211|0.123|<0.0001
71073394|NCT00793624|141656006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.095|0.183|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.183|0.095|<0.0001
71073395|NCT00793624|141656006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.095|0.184|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.184|0.095|<0.0001
71073396|NCT00793624|141656006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.117|0.206|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.206|0.117|<0.0001
71073397|NCT00793624|141656007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.223|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.149|0.297|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.297|0.149|<0.0001
70853440|NCT02270944|141195006|NON_INFERIORITY|To assess the vaccine formulations equivalence, the lower limit of the two-sided 95% confidence interval (CI) for the ratio of GMCs at Day 31 after vaccination must be \> 0.5 and the upper limit of the two-sided 95% CI must be \< 2.0 (the entire two-sided 95% CI must be contained in the 0.5, 2.0 interval).|Ratio of GMCs|0.94|||||TWO_SIDED|95.0|0.72|1.22|||ANCOVA|Analysis of covariance (ANCOVA) model with vaccine group and center as fixed effects and log10-prevaccination antibody concentration as a covariate||to demonstrate the equivalence of the liquid GBS trivalent vaccine formulation to the lyophilized GBS trivalent vaccine formulation for serotypes Ib when administered to healthy non-pregnant women, as measured by geometric mean concentrations (GMC).||1.22|0.72|
71073398|NCT00793624|141656007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.235|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.161|0.309|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.309|0.161|<0.0001
71073399|NCT00793624|141656007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.307|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.233|0.381|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.381|0.233|<0.0001
71073400|NCT00793624|141656008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.236|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.161|0.31|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.310|0.161|<0.0001
71073401|NCT00793624|141656008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.249|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.175|0.324|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.324|0.175|<0.0001
71073402|NCT00793624|141656008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.235|0.384|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.384|0.235|<0.0001
70853441|NCT00095147|141195010|SUPERIORITY_OR_OTHER||adjusted mean change from baseline|-1.04|||<|0.001|TWO_SIDED|95.0|-1.42|-0.67|||ANCOVA|||The primary analysis was the comparison of abatacept versus placebo for changes from baseline to 6 months (Day 197) in the DAS28. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||-0.67|-1.42|<0.001
70853442|NCT00095147|141195011|SUPERIORITY_OR_OTHER||adjusted mean change from baseline|-0.77|||<|0.001|TWO_SIDED|95.0|-1.14|-0.39|||ANCOVA|||Infliximab versus placebo were compared for changes from baseline to 6 months (Day 197) in the DAS28. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||-0.39|-1.14|<0.001
70853443|NCT00095147|141195013|SUPERIORITY_OR_OTHER||Estimate of difference from placebo|20.6||||0.001|TWO_SIDED|95.0|7.7|33.6|||Chi-squared, Corrected|||Comparisons were made between ABA and PLA at Day 197 using a continuity corrected Chi-square test. All tests and confidence intervals for treatment comparison were two-sided.||33.6|7.7|0.001
70853444|NCT00095147|141195013|SUPERIORITY_OR_OTHER||Estimate of difference from placebo|17.9||||0.005|TWO_SIDED|95.0|5.1|30.7|||Chi-squared, Corrected|||Comparisons were made between INF and PLA at Day 197 using a continuity corrected Chi-square test. All tests and confidence intervals for treatment comparison were two-sided.||30.7|5.1|0.005
70853445|NCT00095147|141195015|SUPERIORITY_OR_OTHER||Difference from placebo|-0.38|||<|0.001|TWO_SIDED|95.0|-0.53|-0.23|||ANCOVA|||Adjusted mean change in HAQ-DI from baseline to 6 months (Day 197) was compared between ABA and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||-0.23|-0.53|<0.001
70853446|NCT00095147|141195015|SUPERIORITY_OR_OTHER||Difference from placebo|-0.3|||<|0.001|TWO_SIDED|95.0|-0.45|-0.15|||ANCOVA|||Adjusted mean change in HAQ-DI from baseline to 6 months (Day 197) was compared between INF and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||-0.15|-0.45|<0.001
71073403|NCT00793624|141656009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.135|0.285|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.285|0.135|<0.0001
70940349|NCT00141271|141380803|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6298||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.6298
70940350|NCT00141271|141380803|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6034||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.6034
70853447|NCT00095147|141195017|SUPERIORITY_OR_OTHER||Difference from placebo (PCS)|4.02|||<|0.001|TWO_SIDED|95.0|1.92|6.12|||ANCOVA|||Adjusted mean change in SF-36 physical component summary from baseline to 6 months (Day 197) was compared between ABA and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||6.12|1.92|<0.001
71115349|NCT01942668|141737544|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.136||0.097|TWO_SIDED|95.0|-0.49|0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.04|-0.49|0.097
71115350|NCT01942668|141737544|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.138||0.23|TWO_SIDED|95.0|-0.44|0.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.10|-0.44|0.230
71115351|NCT01942668|141737545|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.17||0.107|TWO_SIDED|95.0|-0.61|0.06||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.06|-0.61|0.107
71115352|NCT01942668|141737545|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.169||0.302|TWO_SIDED|95.0|-0.51|0.16||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.16|-0.51|0.302
71073404|NCT00793624|141656009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.254|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.179|0.329|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.329|0.179|<0.0001
71073405|NCT00793624|141656009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.276|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.201|0.352|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.352|0.201|<0.0001
71115353|NCT01942668|141737545|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.169||0.106|TWO_SIDED|95.0|-0.6|0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.06|-0.60|0.106
71115354|NCT01942668|141737545|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.169||0.156|TWO_SIDED|95.0|-0.57|0.09||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.09|-0.57|0.156
71115355|NCT01942668|141737546|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.177||0.081|TWO_SIDED|95.0|-0.65|0.04||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.04|-0.65|0.081
71073406|NCT00793624|141656010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.107|0.258|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.258|0.107|<0.0001
71073407|NCT00793624|141656010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.139|0.291|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.291|0.139|<0.0001
71115356|NCT01942668|141737546|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.175||0.212|TWO_SIDED|95.0|-0.56|0.12||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.12|-0.56|0.212
71115357|NCT01942668|141737546|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.175||0.345|TWO_SIDED|95.0|-0.51|0.18||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.18|-0.51|0.345
71115358|NCT01942668|141737546|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.176||0.829|TWO_SIDED|95.0|-0.38|0.31||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.31|-0.38|0.829
71115359|NCT01942668|141737547|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.201||0.029|TWO_SIDED|95.0|-0.84|-0.05||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.05|-0.84|0.029
71073408|NCT00793624|141656010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.242|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.166|0.318|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.318|0.166|<0.0001
71073409|NCT00793624|141656011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.179|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.103|0.256|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.256|0.103|<0.0001
71073410|NCT00793624|141656011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.126|0.28|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.280|0.126|<0.0001
71073411|NCT00793624|141656011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.243|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.166|0.32|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.320|0.166|<0.0001
71073412|NCT00793624|141656012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.039||0.0781||95.0|-0.008|0.143|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.143|-0.008|0.0781
71073413|NCT00793624|141656012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.039||0.0455||95.0|0.002|0.153|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.153|0.002|0.0455
71073414|NCT00793624|141656012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.039||0.029||95.0|0.009|0.16|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.160|0.009|0.0290
71073415|NCT00793624|141656013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.039||0.0043||95.0|0.035|0.186|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.186|0.035|0.0043
71073416|NCT00793624|141656013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.039||0.0007||95.0|0.055|0.207|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.207|0.055|0.0007
71073417|NCT00793624|141656013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.039||0.0005||95.0|0.06|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.212|0.060|0.0005
71073418|NCT00793624|141656014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.039||0.0136||95.0|0.02|0.173|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.173|0.020|0.0136
71073419|NCT00793624|141656014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105|STANDARD_ERROR_OF_MEAN|0.039||0.0076||95.0|0.028|0.182|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.182|0.028|0.0076
70853448|NCT00095147|141195017|SUPERIORITY_OR_OTHER||Difference from placebo (MCS)|3.51||||0.004|TWO_SIDED|95.0|1.1|5.91|||ANCOVA|||Adjusted mean change in SF-36 mental component summary from baseline to 6 months (Day 197) was compared between ABA and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||5.91|1.10|0.004
71073420|NCT00793624|141656014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.039||0.0294||95.0|0.009|0.163|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.163|0.009|0.0294
71073421|NCT00793624|141656015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.039||0.8674||95.0|-0.071|0.084|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.084|-0.071|0.8674
71073422|NCT00793624|141656015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.018|STANDARD_ERROR_OF_MEAN|0.04||0.6487||95.0|-0.06|0.096|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.096|-0.060|0.6487
71073423|NCT00793624|141656015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.04||0.9267||95.0|-0.074|0.081|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.081|-0.074|0.9267
71073424|NCT00793624|141656016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.04||0.1603||95.0|-0.022|0.134|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.134|-0.022|0.1603
71073425|NCT00793624|141656016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.04||0.0399||95.0|0.004|0.16|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.160|0.004|0.0399
71073426|NCT00793624|141656016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.019|STANDARD_ERROR_OF_MEAN|0.04||0.6328||95.0|-0.059|0.098|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.098|-0.059|0.6328
71073427|NCT00793624|141656017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.04||0.127||95.0|-0.017|0.139|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.139|-0.017|0.1270
71073428|NCT00793624|141656017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064|STANDARD_ERROR_OF_MEAN|0.04||0.1076||95.0|-0.014|0.143|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.143|-0.014|0.1076
71073429|NCT00793624|141656017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.04||0.1492||95.0|-0.021|0.137|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.137|-0.021|0.1492
71073430|NCT00793624|141656018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.083|STANDARD_ERROR_OF_MEAN|0.04||0.0385||95.0|0.004|0.162|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.162|0.004|0.0385
71073431|NCT00793624|141656018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.04||0.142||95.0|-0.02|0.138|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.138|-0.020|0.1420
71073432|NCT00793624|141656018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.067|STANDARD_ERROR_OF_MEAN|0.04||0.0965||95.0|-0.012|0.147|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.147|-0.012|0.0965
71073433|NCT00793624|141656019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.04||0.1394||95.0|-0.019|0.138|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.138|-0.019|0.1394
71073434|NCT00793624|141656019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.04||0.1532||95.0|-0.022|0.137|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.137|-0.022|0.1532
71073435|NCT00793624|141656019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.041||0.5511||95.0|-0.055|0.104|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.104|-0.055|0.5511
71073436|NCT00793624|141656020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.108|0.264|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.264|0.108|<0.0001
70940351|NCT00141271|141380804|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1454||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1||||0.1454
71073437|NCT00793624|141656020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.128|0.284|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.284|0.128|<0.0001
71073438|NCT00793624|141656020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.283|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.205|0.361|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.361|0.205|<0.0001
70940352|NCT00141271|141380804|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2672||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups.||Week 1||||0.2672
71073439|NCT00793624|141656021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.131|0.288|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.288|0.131|<0.0001
71073440|NCT00793624|141656021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.231|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.153|0.31|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.310|0.153|<0.0001
71073441|NCT00793624|141656021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.187|0.344|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.344|0.187|<0.0001
71073442|NCT00793624|141656022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.108|0.267|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.267|0.108|<0.0001
71073443|NCT00793624|141656022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.159|0.318|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.318|0.159|<0.0001
71073444|NCT00793624|141656022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.256|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.177|0.336|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.336|0.177|<0.0001
71073445|NCT00793624|141656023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.092|0.253|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.253|0.092|<0.0001
71073446|NCT00793624|141656023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.127|0.288|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.288|0.127|<0.0001
71115360|NCT01942668|141737547|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.199||0.026|TWO_SIDED|95.0|-0.84|-0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.05|-0.84|0.026
71115361|NCT01942668|141737547|SUPERIORITY||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.199||0.093|TWO_SIDED|95.0|-0.72|0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.06|-0.72|0.093
71115362|NCT01942668|141737547|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.202||0.223|TWO_SIDED|95.0|-0.64|0.15||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.15|-0.64|0.223
71115363|NCT01942668|141737548|SUPERIORITY||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.85|-0.4||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.40|-0.85|<0.001
71115364|NCT01942668|141737548|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.71|-0.26||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.26|-0.71|<0.001
71115365|NCT01942668|141737548|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.75|-0.3||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.30|-0.75|<0.001
71115366|NCT01942668|141737548|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.64|-0.2||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.20|-0.64|<0.001
71115367|NCT01942668|141737549|SUPERIORITY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.85|-0.38||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.38|-0.85|<0.001
71115368|NCT01942668|141737549|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.69|-0.22||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.22|-0.69|<0.001
71115369|NCT01942668|141737549|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.12||0.003|TWO_SIDED|95.0|-0.59|-0.12||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.12|-0.59|0.003
71115370|NCT01942668|141737549|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.12||0.03|TWO_SIDED|95.0|-0.5|-0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.03|-0.50|0.030
71115371|NCT01942668|141737550|SUPERIORITY||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-0.89|-0.36||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.36|-0.89|<0.001
71115372|NCT01942668|141737550|SUPERIORITY||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-0.88|-0.36||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.36|-0.88|<0.001
71115373|NCT01942668|141737550|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-0.73|-0.21||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.21|-0.73|<0.001
71115374|NCT01942668|141737550|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.13||0.006|TWO_SIDED|95.0|-0.63|-0.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.10|-0.63|0.006
71115375|NCT01942668|141737551|SUPERIORITY||Mean Difference (Final Values)|-4.88|STANDARD_ERROR_OF_MEAN|1.629||0.003|TWO_SIDED|95.0|-8.08|-1.69||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.69|-8.08|0.003
71115376|NCT01942668|141737551|SUPERIORITY||Mean Difference (Final Values)|-3.61|STANDARD_ERROR_OF_MEAN|1.626||0.027|TWO_SIDED|95.0|-6.8|-0.42||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.42|-6.80|0.027
71115377|NCT01942668|141737551|SUPERIORITY||Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|1.618||0.034|TWO_SIDED|95.0|-6.61|-0.26||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.26|-6.61|0.034
71115378|NCT01942668|141737551|SUPERIORITY||Mean Difference (Final Values)|-2.53|STANDARD_ERROR_OF_MEAN|1.621||0.119|TWO_SIDED|95.0|-5.71|0.65||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.65|-5.71|0.119
71115379|NCT01942668|141737552|SUPERIORITY||Mean Difference (Final Values)|-5.39|STANDARD_ERROR_OF_MEAN|1.7||0.002|TWO_SIDED|95.0|-8.73|-2.05||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-2.05|-8.73|0.002
71115380|NCT01942668|141737552|SUPERIORITY||Mean Difference (Final Values)|-5.39|STANDARD_ERROR_OF_MEAN|1.696||0.002|TWO_SIDED|95.0|-8.72|-2.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-2.06|-8.72|0.002
71115381|NCT01942668|141737552|SUPERIORITY||Mean Difference (Final Values)|-4.88|STANDARD_ERROR_OF_MEAN|1.685||0.004|TWO_SIDED|95.0|-8.19|-1.58||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.58|-8.19|0.004
71073447|NCT00793624|141656023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.217|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.137|0.298|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.298|0.137|<0.0001
71073448|NCT00793624|141656024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.041||0.0003||95.0|0.07|0.231|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.231|0.070|0.0003
71073449|NCT00793624|141656024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.096|0.259|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.259|0.096|<0.0001
71073450|NCT00793624|141656024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.223|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001||95.0|0.141|0.304|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.304|0.141|<0.0001
71073451|NCT00793624|141656025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.067|STANDARD_ERROR_OF_MEAN|4.639||0.0012|TWO_SIDED|95.0|5.962|24.173|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean morning PEFR||24.173|5.962|0.0012
71073452|NCT00793624|141656025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.999|STANDARD_ERROR_OF_MEAN|4.611||0.0012||95.0|5.949|24.049|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean morning PEFR||24.049|5.949|0.0012
71073453|NCT00793624|141656025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.642|STANDARD_ERROR_OF_MEAN|4.601||0.0001|TWO_SIDED|95.0|8.61|26.673|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean morning PEFR||26.673|8.610|0.0001
71073454|NCT00793624|141656025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.721|STANDARD_ERROR_OF_MEAN|4.606||0.0001|TWO_SIDED|95.0|8.68|26.762|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean evening PEFR||26.762|8.680|0.0001
71073455|NCT00793624|141656025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.471|STANDARD_ERROR_OF_MEAN|4.579|<|0.0001|TWO_SIDED|95.0|9.484|27.458|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean evening PEFR||27.458|9.484|<0.0001
71073456|NCT00793624|141656025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.873|STANDARD_ERROR_OF_MEAN|4.548|<|0.0001|TWO_SIDED|95.0|8.947|26.799|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean evening PEFR||26.799|8.947|<0.0001
71073457|NCT00793624|141656026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.403|STANDARD_ERROR_OF_MEAN|0.133||0.0026|TWO_SIDED|95.0|-0.665|-0.141|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||-0.141|-0.665|0.0026
71073458|NCT00793624|141656026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.327|STANDARD_ERROR_OF_MEAN|0.133||0.0141|TWO_SIDED|95.0|-0.587|-0.066|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||-0.066|-0.587|0.0141
71073459|NCT00793624|141656026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.147|STANDARD_ERROR_OF_MEAN|0.132||0.2677|TWO_SIDED|95.0|-0.406|0.113|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||0.113|-0.406|0.2677
71073460|NCT00793624|141656026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.602|STANDARD_ERROR_OF_MEAN|0.171||0.0005|TWO_SIDED|95.0|-0.939|-0.266|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||-0.266|-0.939|0.0005
71115382|NCT01942668|141737552|SUPERIORITY||Mean Difference (Final Values)|-4.42|STANDARD_ERROR_OF_MEAN|1.698||0.009|TWO_SIDED|95.0|-7.75|-1.09||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.09|-7.75|0.009
71115383|NCT01942668|141737553|SUPERIORITY||Mean Difference (Final Values)|-6.54|STANDARD_ERROR_OF_MEAN|1.855|<|0.001|TWO_SIDED|95.0|-10.18|-2.9||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.90|-10.18|<0.001
71115384|NCT01942668|141737553|SUPERIORITY||Mean Difference (Final Values)|-7.61|STANDARD_ERROR_OF_MEAN|1.843|<|0.001|TWO_SIDED|95.0|-11.23|-4.0||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-4.00|-11.23|<0.001
71073461|NCT00793624|141656026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.17||0.0007|TWO_SIDED|95.0|-0.914|-0.247|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||-0.247|-0.914|0.0007
71073462|NCT00793624|141656026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.169||0.0391|TWO_SIDED|95.0|-0.683|-0.018|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||-0.018|-0.683|0.0391
71073463|NCT00793624|141656026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.991|STANDARD_ERROR_OF_MEAN|0.269||0.0002|TWO_SIDED|95.0|-1.518|-0.464|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use||-0.464|-1.518|0.0002
71073464|NCT00793624|141656026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.902|STANDARD_ERROR_OF_MEAN|0.267||0.0008|TWO_SIDED|95.0|-1.426|-0.378|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use||-0.378|-1.426|0.0008
71073465|NCT00793624|141656026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.473|STANDARD_ERROR_OF_MEAN|0.266||0.0758|TWO_SIDED|95.0|-0.994|0.049|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use||0.049|-0.994|0.0758
71073466|NCT00793624|141656027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0003||95.0|-0.6|-0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.2|-0.6|0.0003
71073467|NCT00793624|141656027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0073||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.1|-0.5|0.0073
71073468|NCT00793624|141656027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0017||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||-0.1|-0.5|0.0017
71073469|NCT00793624|141656028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0021||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.1|-0.5|0.0021
71073470|NCT00793624|141656028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.6|-0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.2|-0.6|<0.0001
71073471|NCT00793624|141656028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0121||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||-0.1|-0.5|0.0121
71073472|NCT00793624|141656029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.032||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.0|-0.4|0.0320
71073473|NCT00793624|141656029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0447||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.0|-0.4|0.0447
71115385|NCT01942668|141737553|SUPERIORITY||Mean Difference (Final Values)|-7.44|STANDARD_ERROR_OF_MEAN|1.835|<|0.001|TWO_SIDED|95.0|-11.04|-3.84||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.84|-11.04|<0.001
71115386|NCT01942668|141737553|SUPERIORITY||Mean Difference (Final Values)|-6.76|STANDARD_ERROR_OF_MEAN|1.863|<|0.001|TWO_SIDED|95.0|-10.41|-3.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.10|-10.41|<0.001
71115387|NCT01942668|141737554|SUPERIORITY||Mean Difference (Final Values)|-7.34|STANDARD_ERROR_OF_MEAN|2.146|<|0.001|TWO_SIDED|95.0|-11.55|-3.13||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-3.13|-11.55|<0.001
71073474|NCT00793624|141656029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1332||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||0.0|-0.4|0.1332
71073475|NCT00793624|141656030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4105||95.0|-0.3|0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||0.1|-0.3|0.4105
71073476|NCT00793624|141656030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0584||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||0.0|-0.4|0.0584
71073477|NCT00793624|141656030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1006||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||0.0|-0.4|0.1006
71073478|NCT00793624|141656031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.571|STANDARD_ERROR_OF_MEAN|0.335||0.0882||95.0|-0.085|1.227|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.227|-0.085|0.0882
71073479|NCT00793624|141656031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.664|STANDARD_ERROR_OF_MEAN|0.336||0.0484||95.0|0.005|1.324|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.324|0.005|0.0484
71073480|NCT00793624|141656031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.758|STANDARD_ERROR_OF_MEAN|0.338||0.0252||95.0|0.094|1.421|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.421|0.094|0.0252
71073481|NCT00793624|141656032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.381|STANDARD_ERROR_OF_MEAN|0.34||0.2625||95.0|-0.285|1.047|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.047|-0.285|0.2625
71115388|NCT01942668|141737554|SUPERIORITY||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|2.139||0.009|TWO_SIDED|95.0|-9.8|-1.4||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.40|-9.80|0.009
71073482|NCT00793624|141656032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.543|STANDARD_ERROR_OF_MEAN|0.341||0.1109||95.0|-0.125|1.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.211|-0.125|0.1109
71073483|NCT00793624|141656032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.394|STANDARD_ERROR_OF_MEAN|0.343||0.2507||95.0|-0.278|1.066|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.066|-0.278|0.2507
71073484|NCT00793624|141656033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.342||0.4895||95.0|-0.439|0.902|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.902|-0.439|0.4895
71073485|NCT00793624|141656033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.434|STANDARD_ERROR_OF_MEAN|0.344||0.2073||95.0|-0.24|1.107|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.107|-0.240|0.2073
71073486|NCT00793624|141656033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.345||0.9462||95.0|-0.653|0.7|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.700|-0.653|0.9462
71073487|NCT00793624|141656034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.345||0.6309||95.0|-0.511|0.842|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.842|-0.511|0.6309
71115389|NCT01942668|141737554|SUPERIORITY||Mean Difference (Final Values)|-5.13|STANDARD_ERROR_OF_MEAN|2.132||0.016|TWO_SIDED|95.0|-9.31|-0.95||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.95|-9.31|0.016
71115390|NCT01942668|141737554|SUPERIORITY||Mean Difference (Final Values)|-3.04|STANDARD_ERROR_OF_MEAN|2.13||0.154|TWO_SIDED|95.0|-7.22|1.14||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||1.14|-7.22|0.154
71073488|NCT00793624|141656034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.034|STANDARD_ERROR_OF_MEAN|0.348||0.9227||95.0|-0.717|0.649|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.649|-0.717|0.9227
71073489|NCT00793624|141656034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.234|STANDARD_ERROR_OF_MEAN|0.349||0.503||95.0|-0.451|0.919|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.919|-0.451|0.5030
71073490|NCT00793624|141656035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.112|STANDARD_ERROR_OF_MEAN|0.347||0.7459||95.0|-0.793|0.568|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.568|-0.793|0.7459
71115391|NCT01942668|141737555|SUPERIORITY||Mean Difference (Final Values)|-8.38|STANDARD_ERROR_OF_MEAN|2.213|<|0.001|TWO_SIDED|95.0|-12.72|-4.04||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-4.04|-12.72|<0.001
71115392|NCT01942668|141737555|SUPERIORITY||Mean Difference (Final Values)|-7.52|STANDARD_ERROR_OF_MEAN|2.201|<|0.001|TWO_SIDED|95.0|-11.83|-3.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-3.20|-11.83|<0.001
71073491|NCT00793624|141656035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.065|STANDARD_ERROR_OF_MEAN|0.351||0.8534||95.0|-0.753|0.623|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.623|-0.753|0.8534
71073492|NCT00793624|141656035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.377|STANDARD_ERROR_OF_MEAN|0.352||0.5099||95.0|-1.068|0.314|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.314|-1.068|0.5099
71073493|NCT00793624|141656036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.095|STANDARD_ERROR_OF_MEAN|0.348||0.785||95.0|-0.587|0.777|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.777|-0.587|0.7850
71073494|NCT00793624|141656036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.383|STANDARD_ERROR_OF_MEAN|0.352||0.2755||95.0|-0.306|1.073|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.073|-0.306|0.2755
71073495|NCT00793624|141656036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.353||0.7618||95.0|-0.584|0.798|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.798|-0.584|0.7618
71073496|NCT00793624|141656037|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.162|STANDARD_ERROR_OF_MEAN|0.19||0.3424||95.0|0.843|1.603|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.603|0.843|0.3424
71073497|NCT00793624|141656037|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.186|STANDARD_ERROR_OF_MEAN|0.195||0.3023||95.0|0.859|1.636|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.636|0.859|0.3023
71073498|NCT00793624|141656037|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.854|STANDARD_ERROR_OF_MEAN|0.15||0.3589||95.0|0.605|1.205|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum|||1.205|0.605|0.3589
71073499|NCT00793624|141656038|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.818|STANDARD_ERROR_OF_MEAN|0.841||0.191||95.0|0.734|4.503|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||4.503|0.734|0.1910
71073500|NCT00793624|141656038|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.743|STANDARD_ERROR_OF_MEAN|0.817||0.2274||95.0|0.695|4.369|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||4.369|0.695|0.2274
71073501|NCT00793624|141656038|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.346|STANDARD_ERROR_OF_MEAN|0.664||0.5538||95.0|0.512|3.538|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum|||3.538|0.512|0.5538
70940353|NCT00141271|141380804|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2614||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups.||Week 2||||0.2614
71073502|NCT00793624|141656039|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.101|STANDARD_ERROR_OF_MEAN|0.195||0.5577||95.0|0.778|1.557|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.557|0.778|0.5577
71073503|NCT00793624|141656039|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.017|STANDARD_ERROR_OF_MEAN|0.184||0.9423||95.0|0.714|1.448|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.448|0.714|0.9423
71073504|NCT00793624|141656039|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.735|STANDARD_ERROR_OF_MEAN|0.143||0.1097||95.0|0.502|1.076|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum|||1.076|0.502|0.1097
71073505|NCT00793624|141656040|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.2521|STANDARD_ERROR_OF_MEAN|0.2064||0.1729||95.0|0.906|1.7304|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.7304|0.9060|0.1729
71073506|NCT00793624|141656040|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.222|STANDARD_ERROR_OF_MEAN|0.2039||0.2297||95.0|0.8808|1.6954|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.6954|0.8808|0.2297
71073507|NCT00793624|141656040|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.8968|STANDARD_ERROR_OF_MEAN|0.1575||0.5354||95.0|0.6353|1.2659|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo|||1.2659|0.6353|0.5354
71073508|NCT00793624|141656041|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.8821|STANDARD_ERROR_OF_MEAN|1.0358||0.2508||95.0|0.6391|5.543|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||5.5430|0.6391|0.2508
71073509|NCT00793624|141656041|SUPERIORITY_OR_OTHER||Incidence rate ratio|2.3877|STANDARD_ERROR_OF_MEAN|1.3119||0.1135||95.0|0.8122|7.0194|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||7.0194|0.8122|0.1135
71073510|NCT00793624|141656041|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.0289|STANDARD_ERROR_OF_MEAN|0.6013||0.9611||95.0|0.3268|3.2395|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo|||3.2395|0.3268|0.9611
71073511|NCT00793624|141656042|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.1621|STANDARD_ERROR_OF_MEAN|0.2075||0.4002||95.0|0.8187|1.6497|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.6497|0.8187|0.4002
71073512|NCT00793624|141656042|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.0733|STANDARD_ERROR_OF_MEAN|0.1957||0.6983||95.0|0.7503|1.5352|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.5352|0.7503|0.6983
71073513|NCT00793624|141656042|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.781|STANDARD_ERROR_OF_MEAN|0.1516||0.2033||95.0|0.5336|1.1433|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo|||1.1433|0.5336|0.2033
71073514|NCT00793624|141656045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.509|STANDARD_ERROR_OF_MEAN|0.23||0.027||95.0|0.058|0.96|||pattern mixture model|See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455-1497(2004)|"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1\) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Olo 5mcg minus placebo||0.960|0.058|0.0270
71073515|NCT00793624|141656045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.525|STANDARD_ERROR_OF_MEAN|0.226||0.0203||95.0|0.082|0.967||See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455-1497(2004)|pattern mixture model||"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1\) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Olo 10 mcg minus placebo||0.967|0.082|0.0203
71073516|NCT00793624|141656045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.355|STANDARD_ERROR_OF_MEAN|0.226||0.1166||95.0|-0.088|0.799|||pattern mixture model|See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455-1497(2004)|"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1\) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Form 12mcg minus placebo||0.799|-0.088|0.1166
71073517|NCT00710684|141656046|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.279|TWO_SIDED|95.0|-1.9|0.5|||mixed model for repeated measures (MMRM)|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15mg versus placebo at Week 24||0.5|-1.9|0.279
71073518|NCT00710684|141656046|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.012|TWO_SIDED|95.0|-2.7|-0.3|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35mg versus placebo at Week 24||-0.3|-2.7|0.012
71073519|NCT00710684|141656047|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.711|TWO_SIDED|95.0|-0.4|0.3|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 24||0.3|-0.4|0.711
71073520|NCT00710684|141656047|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.462|TWO_SIDED|95.0|-0.5|0.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 24||0.2|-0.5|0.462
71073521|NCT00710684|141656048|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4||||0.174|TWO_SIDED|95.0|-5.8|1.1|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 24||1.1|-5.8|0.174
71073522|NCT00710684|141656048|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.776|TWO_SIDED|95.0|-3.6|2.7|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 24||2.7|-3.6|0.776
71115393|NCT01942668|141737555|SUPERIORITY||Mean Difference (Final Values)|-7.32|STANDARD_ERROR_OF_MEAN|2.193|<|0.001|TWO_SIDED|95.0|-11.63|-3.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-3.02|-11.63|<0.001
71115394|NCT01942668|141737555|SUPERIORITY||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|2.207||0.011|TWO_SIDED|95.0|-9.93|-1.27||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.27|-9.93|0.011
70940354|NCT00141271|141380804|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2143||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.2143
71073523|NCT00710684|141656049|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.631|TWO_SIDED|95.0|-1.2|0.7|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 12||0.7|-1.2|0.631
71073524|NCT00710684|141656049|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.006|TWO_SIDED|95.0|-2.2|-0.4|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 12||-0.4|-2.2|0.006
71073525|NCT00710684|141656049|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.947|TWO_SIDED|95.0|-1.3|1.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 36||1.2|-1.3|0.947
71073526|NCT00710684|141656049|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.057|TWO_SIDED|95.0|-2.5|0.0|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 36||0.0|-2.5|0.057
71073527|NCT00710684|141656049|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.925|TWO_SIDED|95.0|-1.6|1.5|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 48||1.5|-1.6|0.925
71073528|NCT00710684|141656049|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.024|TWO_SIDED|95.0|-3.1|-0.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 48||-0.2|-3.1|0.024
71073529|NCT00710684|141656050|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.387|TWO_SIDED|95.0|-0.4|0.1|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 12||0.1|-0.4|0.387
71073530|NCT00710684|141656050|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.018|TWO_SIDED|95.0|-0.5|-0.1|||MMRM|||SB-742457 35 mg versus placebo at Week 12||-0.1|-0.5|0.018
71073531|NCT00710684|141656050|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.439|TWO_SIDED|95.0|-0.3|0.6|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 36||0.6|-0.3|0.439
71073532|NCT00710684|141656050|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.336|TWO_SIDED|95.0|-0.6|0.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 36||0.2|-0.6|0.336
71073533|NCT00710684|141656050|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.19|TWO_SIDED|95.0|-0.2|0.8|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 48||0.8|-0.2|0.190
71073534|NCT00710684|141656050|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.787|TWO_SIDED|95.0|-0.5|0.4|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 48||0.4|-0.5|0.787
71073535|NCT00710684|141656051|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.337|TWO_SIDED|95.0|-4.0|1.4|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 12||1.4|-4.0|0.337
71073536|NCT00710684|141656051|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.596|TWO_SIDED|95.0|-1.7|3.0|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 12||3.0|-1.7|0.596
71073537|NCT00710684|141656051|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.634|TWO_SIDED|95.0|-4.4|2.7|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 36||2.7|-4.4|0.634
71073538|NCT00710684|141656051|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.1||||0.238|TWO_SIDED|95.0|-1.4|5.6|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 36||5.6|-1.4|0.238
71073539|NCT00710684|141656051|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.1||||0.292|TWO_SIDED|95.0|-6.0|1.8|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 48||1.8|-6.0|0.292
71073540|NCT00710684|141656051|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.6||||0.161|TWO_SIDED|95.0|-1.0|6.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 48||6.2|-1.0|0.161
71073541|NCT00710684|141656052|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.396|TWO_SIDED|95.0|-0.8|2.1|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 12||2.1|-0.8|0.396
71073542|NCT00710684|141656052|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.7||||0.019|TWO_SIDED|95.0|0.3|3.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 12||3.2|0.3|0.019
71073543|NCT00710684|141656052|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4||||0.11|TWO_SIDED|95.0|-0.3|3.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 24||3.2|-0.3|0.110
71073544|NCT00710684|141656052|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0||||0.024|TWO_SIDED|95.0|0.3|3.7|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 24||3.7|0.3|0.024
70940355|NCT00141271|141380804|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6997||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.6997
71073545|NCT00710684|141656052|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.944|TWO_SIDED|95.0|-2.1|2.0|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo ate Week 36||2.0|-2.1|0.944
71073546|NCT00710684|141656052|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9||||0.037|TWO_SIDED|95.0|0.1|3.8|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 36||3.8|0.1|0.037
71073547|NCT00710684|141656052|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5||||0.705|TWO_SIDED|95.0|-1.9|2.9|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 48||2.9|-1.9|0.705
71073548|NCT00710684|141656052|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9||||0.088|TWO_SIDED|95.0|-0.3|4.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 48||4.2|-0.3|0.088
71073549|NCT00710684|141656053|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.962|TWO_SIDED|95.0|-0.6|0.6|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 24||0.6|-0.6|0.962
71073550|NCT00710684|141656053|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.134|TWO_SIDED|95.0|-0.1|1.0|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 24||1.0|-0.1|0.134
71073551|NCT00710684|141656053|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.782|TWO_SIDED|95.0|-1.0|0.7|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 48||0.7|-1.0|0.782
71073552|NCT00710684|141656053|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.268|TWO_SIDED|95.0|-0.3|1.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 48||1.2|-0.3|0.268
71073553|NCT01254851|141656091|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|0.39||||0.7|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.70
71073554|NCT02987972|141656097|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.1|||<|0.001|TWO_SIDED|95.0|-3.3|3.0|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 1||3.0|-3.3|< 0.001
71073555|NCT02987972|141656097|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|24.2|||<|0.001|TWO_SIDED|95.0|18.7|30.0|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar|Type 3||30.0|18.7|< 0.001
71115395|NCT01942668|141737556|SUPERIORITY||Mean Difference (Final Values)|-8.97|STANDARD_ERROR_OF_MEAN|2.439|<|0.001|TWO_SIDED|95.0|-13.76|-4.19||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-4.19|-13.76|<0.001
71115396|NCT01942668|141737556|SUPERIORITY||Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|2.42|<|0.001|TWO_SIDED|95.0|-14.34|-4.85||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-4.85|-14.34|<0.001
71073556|NCT02987972|141656097|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|3.0|||<|0.001|TWO_SIDED|95.0|0.0|6.4|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 4||6.4|0.0|< 0.001
71073557|NCT02987972|141656097|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.5|||<|0.001|TWO_SIDED|95.0|-3.9|2.8|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 5||2.8|-3.9|< 0.001
71073558|NCT02987972|141656097|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-5.6|||<|0.001|TWO_SIDED|95.0|-10.0|-1.6|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 6A||-1.6|-10.0|< 0.001
71073559|NCT02987972|141656097|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.8|||<|0.001|TWO_SIDED|95.0|-5.7|4.0|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 6B||4.0|-5.7|< 0.001
71073560|NCT02987972|141656097|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.7|||<|0.001|TWO_SIDED|95.0|-1.1|2.7|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 7F||2.7|-1.1|< 0.001
71073561|NCT02987972|141656097|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|1.3|||<|0.001|TWO_SIDED|95.0|-1.9|4.6|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 9V||4.6|-1.9|< 0.001
71073562|NCT02987972|141656097|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|2.0|||<|0.001|TWO_SIDED|95.0|-0.2|4.7|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 14||4.7|-0.2|< 0.001
71073563|NCT02987972|141656097|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|1.2|||<|0.001|TWO_SIDED|95.0|-2.1|4.7|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 18C||4.7|-2.1|< 0.001
71073564|NCT02987972|141656097|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.3|||<|0.001|TWO_SIDED|95.0|-1.9|2.6|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 19A||2.6|-1.9|< 0.001
71073565|NCT02987972|141656097|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.3|||<|0.001|TWO_SIDED|95.0|-1.0|1.9|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 19F||1.9|-1.0|< 0.001
71073566|NCT02987972|141656097|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|1.8|||<|0.001|TWO_SIDED|95.0|-2.9|6.5|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 23F||6.5|-2.9|< 0.001
71073567|NCT02987972|141656097|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.9|||<|0.001|TWO_SIDED|95.0|-2.0|3.9|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 1||3.9|-2.0|< 0.001
71073568|NCT02987972|141656097|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|22.3|||<|0.001|TWO_SIDED|95.0|16.5|28.3|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 3||28.3|16.5|< 0.001
71073569|NCT02987972|141656097|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|1.9|||<|0.001|TWO_SIDED|95.0|-1.4|5.4|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 4||5.4|-1.4|< 0.001
71073570|NCT02987972|141656097|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.6|||<|0.001|TWO_SIDED|95.0|-4.1|2.7|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 5||2.7|-4.1|< 0.001
71073571|NCT02987972|141656097|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.6|||<|0.001|TWO_SIDED|95.0|-4.2|2.8|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 6A||2.8|-4.2|< 0.001
71073572|NCT02987972|141656097|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.9|||<|0.001|TWO_SIDED|95.0|-3.7|5.6|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 6B||5.6|-3.7|< 0.001
71115397|NCT01942668|141737556|SUPERIORITY||Mean Difference (Final Values)|-9.3|STANDARD_ERROR_OF_MEAN|2.412|<|0.001|TWO_SIDED|95.0|-14.03|-4.56||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-4.56|-14.03|<0.001
71115398|NCT01942668|141737556|SUPERIORITY||Mean Difference (Final Values)|-7.72|STANDARD_ERROR_OF_MEAN|2.442||0.002|TWO_SIDED|95.0|-12.51|-2.93||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.93|-12.51|0.002
71115399|NCT01942668|141737557|SUPERIORITY||Mean Difference (Final Values)|2.02|STANDARD_ERROR_OF_MEAN|2.576||0.434|TWO_SIDED|95.0|-3.03|7.07||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||7.07|-3.03|0.434
71073573|NCT02987972|141656097|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.3|||<|0.001|TWO_SIDED|95.0|-1.7|2.4|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 7F||2.4|-1.7|< 0.001
71073574|NCT02987972|141656097|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|2.0|||<|0.001|TWO_SIDED|95.0|-1.1|5.2|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 9V||5.2|-1.1|< 0.001
71073575|NCT02987972|141656097|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.2|||<|0.001|TWO_SIDED|95.0|-2.8|3.1|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 14||3.1|-2.8|< 0.001
71115400|NCT01942668|141737557|SUPERIORITY||Mean Difference (Final Values)|1.97|STANDARD_ERROR_OF_MEAN|2.564||0.442|TWO_SIDED|95.0|-3.06|7.0||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||7.00|-3.06|0.442
71115401|NCT01942668|141737557|SUPERIORITY||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|2.558||0.558|TWO_SIDED|95.0|-3.52|6.51||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||6.51|-3.52|0.558
71115402|NCT01942668|141737557|SUPERIORITY||Mean Difference (Final Values)|1.59|STANDARD_ERROR_OF_MEAN|2.555||0.534|TWO_SIDED|95.0|-3.42|6.6||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||6.60|-3.42|0.534
71115403|NCT01942668|141737558|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|2.719||0.927|TWO_SIDED|95.0|-5.08|5.58||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||5.58|-5.08|0.927
71115404|NCT01942668|141737558|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|2.699||0.541|TWO_SIDED|95.0|-6.95|3.64||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||3.64|-6.95|0.541
71115405|NCT01942668|141737558|SUPERIORITY||Mean Difference (Final Values)|-3.68|STANDARD_ERROR_OF_MEAN|2.691||0.171|TWO_SIDED|95.0|-8.96|1.6||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||1.60|-8.96|0.171
71115406|NCT01942668|141737558|SUPERIORITY||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|2.708||0.667|TWO_SIDED|95.0|-6.48|4.15||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||4.15|-6.48|0.667
71115407|NCT01942668|141737559|SUPERIORITY||Mean Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|2.863||0.662|TWO_SIDED|95.0|-4.36|6.87||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||6.87|-4.36|0.662
71115408|NCT01942668|141737559|SUPERIORITY||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|2.834||0.635|TWO_SIDED|95.0|-6.91|4.21||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||4.21|-6.91|0.635
71115409|NCT01942668|141737559|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|2.827||0.877|TWO_SIDED|95.0|-5.98|5.11||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||5.11|-5.98|0.877
71115410|NCT01942668|141737559|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|2.867||0.893|TWO_SIDED|95.0|-6.01|5.24||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||5.24|-6.01|0.893
71115411|NCT01942668|141737560|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|2.058||0.83|TWO_SIDED|95.0|-4.48|3.59||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||3.59|-4.48|0.830
71115412|NCT01942668|141737560|SUPERIORITY||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|2.05||0.755|TWO_SIDED|95.0|-4.66|3.38||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||3.38|-4.66|0.755
71115413|NCT01942668|141737560|SUPERIORITY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|2.046||0.802|TWO_SIDED|95.0|-3.5|4.53||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||4.53|-3.50|0.802
71115414|NCT01942668|141737560|SUPERIORITY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|2.043||0.823|TWO_SIDED|95.0|-4.46|3.55||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||3.55|-4.46|0.823
71115415|NCT01942668|141737561|SUPERIORITY||Mean Difference (Final Values)|-2.46|STANDARD_ERROR_OF_MEAN|2.166||0.255|TWO_SIDED|95.0|-6.71|1.78||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||1.78|-6.71|0.255
71115416|NCT01942668|141737561|SUPERIORITY||Mean Difference (Final Values)|-2.27|STANDARD_ERROR_OF_MEAN|2.154||0.293|TWO_SIDED|95.0|-6.49|1.96||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||1.96|-6.49|0.293
71115417|NCT01942668|141737561|SUPERIORITY||Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|2.148||0.502|TWO_SIDED|95.0|-5.66|2.77||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||2.77|-5.66|0.502
71115418|NCT01942668|141737561|SUPERIORITY||Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|2.161||0.495|TWO_SIDED|95.0|-5.71|2.76||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||2.76|-5.71|0.495
71115419|NCT01942668|141737562|SUPERIORITY||Mean Difference (Final Values)|-1.96|STANDARD_ERROR_OF_MEAN|2.274||0.389|TWO_SIDED|95.0|-6.42|2.5||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||2.50|-6.42|0.389
71115420|NCT01942668|141737562|SUPERIORITY||Mean Difference (Final Values)|-2.43|STANDARD_ERROR_OF_MEAN|2.253||0.281|TWO_SIDED|95.0|-6.85|1.99||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||1.99|-6.85|0.281
71115421|NCT01942668|141737562|SUPERIORITY||Mean Difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|2.25||0.504|TWO_SIDED|95.0|-5.92|2.91||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||2.91|-5.92|0.504
71115422|NCT01942668|141737562|SUPERIORITY||Mean Difference (Final Values)|-1.68|STANDARD_ERROR_OF_MEAN|2.277||0.46|TWO_SIDED|95.0|-6.15|2.78||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||2.78|-6.15|0.460
71115423|NCT01942668|141737563|SUPERIORITY||Mean Difference (Final Values)|4.35|STANDARD_ERROR_OF_MEAN|2.513||0.084|TWO_SIDED|95.0|-0.58|9.28||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||9.28|-0.58|0.084
71115424|NCT01942668|141737563|SUPERIORITY||Mean Difference (Final Values)|2.61|STANDARD_ERROR_OF_MEAN|2.506||0.298|TWO_SIDED|95.0|-2.3|7.53||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||7.53|-2.30|0.298
71115425|NCT01942668|141737563|SUPERIORITY||Mean Difference (Final Values)|3.72|STANDARD_ERROR_OF_MEAN|2.496||0.136|TWO_SIDED|95.0|-1.17|8.62||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||8.62|-1.17|0.136
70940356|NCT00141271|141380804|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0128||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.0128
70940357|NCT00141271|141380804|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1144||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.1144
71115426|NCT01942668|141737563|SUPERIORITY||Mean Difference (Final Values)|3.48|STANDARD_ERROR_OF_MEAN|2.492||0.163|TWO_SIDED|95.0|-1.41|8.37||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||8.37|-1.41|0.163
71115427|NCT01942668|141737564|SUPERIORITY||Mean Difference (Final Values)|5.11|STANDARD_ERROR_OF_MEAN|2.647||0.054|TWO_SIDED|95.0|-0.08|10.31||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||10.31|-0.08|0.054
71115428|NCT01942668|141737564|SUPERIORITY||Mean Difference (Final Values)|7.1|STANDARD_ERROR_OF_MEAN|2.634||0.007|TWO_SIDED|95.0|1.93|12.26||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||12.26|1.93|0.007
71115429|NCT01942668|141737564|SUPERIORITY||Mean Difference (Final Values)|5.9|STANDARD_ERROR_OF_MEAN|2.623||0.025|TWO_SIDED|95.0|0.75|11.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||11.04|0.75|0.025
71115430|NCT01942668|141737564|SUPERIORITY||Mean Difference (Final Values)|8.38|STANDARD_ERROR_OF_MEAN|2.638||0.002|TWO_SIDED|95.0|3.2|13.55||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||13.55|3.20|0.002
71115431|NCT01942668|141737565|SUPERIORITY||Mean Difference (Final Values)|5.02|STANDARD_ERROR_OF_MEAN|2.945||0.089|TWO_SIDED|95.0|-0.76|10.8||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||10.80|-0.76|0.089
71073576|NCT02987972|141656097|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|2.6|||<|0.001|TWO_SIDED|95.0|-0.3|5.9|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 18C||5.9|-0.3|< 0.001
71073577|NCT02987972|141656097|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.1|||<|0.001|TWO_SIDED|95.0|-2.5|2.2|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 19A||2.2|-2.5|< 0.001
71073578|NCT02987972|141656097|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.8|||<|0.001|TWO_SIDED|95.0|-2.9|0.9|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 19F||0.9|-2.9|< 0.001
71073579|NCT02987972|141656097|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|4.2|||<|0.001|TWO_SIDED|95.0|-0.1|8.7|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 23F||8.7|-0.1|< 0.001
71073580|NCT02987972|141656098|OTHER||GMC Ratio|0.72|||||TWO_SIDED|95.0|0.64|0.81|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on analysis of variance (ANOVA) model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1||0.81|0.64|
71073581|NCT02987972|141656098|OTHER||GMC Ratio|1.98|||||TWO_SIDED|95.0|1.75|2.23|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3||2.23|1.75|
71073582|NCT02987972|141656098|OTHER||GMC Ratio|1.04|||||TWO_SIDED|95.0|0.92|1.16|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4||1.16|0.92|
71073583|NCT02987972|141656098|OTHER||GMC Ratio|0.78|||||TWO_SIDED|95.0|0.68|0.89|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5||0.89|0.68|
71073584|NCT02987972|141656098|OTHER||GMC Ratio|0.54|||||TWO_SIDED|95.0|0.47|0.63|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A||0.63|0.47|
71073585|NCT02987972|141656098|OTHER||GMC Ratio|1.03|||||TWO_SIDED|95.0|0.84|1.26|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B||1.26|0.84|
71073586|NCT02987972|141656098|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.73|0.92|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F||0.92|0.73|
71073587|NCT02987972|141656098|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.77|1.0|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V||1.00|0.77|
71073588|NCT02987972|141656098|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.75|1.03|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14||1.03|0.75|
71073589|NCT02987972|141656098|OTHER||GMC Ratio|0.75|||||TWO_SIDED|95.0|0.66|0.84|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 18C||0.84|0.66|
71115432|NCT01942668|141737565|SUPERIORITY||Mean Difference (Final Values)|7.56|STANDARD_ERROR_OF_MEAN|2.92||0.01|TWO_SIDED|95.0|1.83|13.29||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||13.29|1.83|0.010
71115433|NCT01942668|141737565|SUPERIORITY||Mean Difference (Final Values)|7.65|STANDARD_ERROR_OF_MEAN|2.911||0.009|TWO_SIDED|95.0|1.94|13.36||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||13.36|1.94|0.009
71115434|NCT01942668|141737565|SUPERIORITY||Mean Difference (Final Values)|7.89|STANDARD_ERROR_OF_MEAN|2.944||0.007|TWO_SIDED|95.0|2.11|13.67||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||13.67|2.11|0.007
71115435|NCT01942668|141737566|SUPERIORITY||Mean Difference (Final Values)|-1.64|STANDARD_ERROR_OF_MEAN|1.749||0.349|TWO_SIDED|95.0|-5.07|1.79||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||1.79|-5.07|0.349
71115436|NCT01942668|141737566|SUPERIORITY||Mean Difference (Final Values)|-1.18|STANDARD_ERROR_OF_MEAN|1.743||0.499|TWO_SIDED|95.0|-4.6|2.24||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||2.24|-4.60|0.499
71115437|NCT01942668|141737566|SUPERIORITY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|1.737||0.936|TWO_SIDED|95.0|-3.27|3.55||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||3.55|-3.27|0.936
71115438|NCT01942668|141737566|SUPERIORITY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|1.736||0.696|TWO_SIDED|95.0|-4.08|2.72||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||2.72|-4.08|0.696
71073590|NCT02987972|141656098|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.73|0.92|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A||0.92|0.73|
71073591|NCT02987972|141656098|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.79|0.98|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on analysis of variance (ANOVA) model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F||0.98|0.79|
71073592|NCT02987972|141656098|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.84|1.13|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F||1.13|0.84|
71073593|NCT02987972|141656098|OTHER||GMC Ratio|92.05|||||TWO_SIDED|95.0|80.84|104.81|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 22F||104.81|80.84|
71115439|NCT01942668|141737567|SUPERIORITY||Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|1.924||0.572|TWO_SIDED|95.0|-4.86|2.69||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||2.69|-4.86|0.572
71115440|NCT01942668|141737567|SUPERIORITY||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|1.914||0.553|TWO_SIDED|95.0|-4.89|2.62||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||2.62|-4.89|0.553
71115441|NCT01942668|141737567|SUPERIORITY||Mean Difference (Final Values)|-1.42|STANDARD_ERROR_OF_MEAN|1.907||0.456|TWO_SIDED|95.0|-5.16|2.32||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||2.32|-5.16|0.456
71115442|NCT01942668|141737567|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|1.919||0.949|TWO_SIDED|95.0|-3.89|3.64||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||3.64|-3.89|0.949
71115443|NCT01942668|141737568|SUPERIORITY||Mean Difference (Final Values)|-3.36|STANDARD_ERROR_OF_MEAN|2.026||0.097|TWO_SIDED|95.0|-7.34|0.61||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.61|-7.34|0.097
71115444|NCT01942668|141737568|SUPERIORITY||Mean Difference (Final Values)|-5.34|STANDARD_ERROR_OF_MEAN|2.01||0.008|TWO_SIDED|95.0|-9.28|-1.4||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-1.40|-9.28|0.008
71115445|NCT01942668|141737568|SUPERIORITY||Mean Difference (Final Values)|-4.94|STANDARD_ERROR_OF_MEAN|2.003||0.014|TWO_SIDED|95.0|-8.87|-1.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-1.01|-8.87|0.014
71115446|NCT01942668|141737568|SUPERIORITY||Mean Difference (Final Values)|-3.88|STANDARD_ERROR_OF_MEAN|2.029||0.056|TWO_SIDED|95.0|-7.86|0.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.10|-7.86|0.056
71115447|NCT01942668|141737569|SUPERIORITY||Mean Difference (Final Values)|-4.92|STANDARD_ERROR_OF_MEAN|1.665||0.003|TWO_SIDED|95.0|-8.18|-1.65||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.65|-8.18|0.003
71115448|NCT01942668|141737569|SUPERIORITY||Mean Difference (Final Values)|-3.79|STANDARD_ERROR_OF_MEAN|1.66||0.023|TWO_SIDED|95.0|-7.05|-0.53||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.53|-7.05|0.023
71073594|NCT02987972|141656098|OTHER||GMC Ratio|34.41|||||TWO_SIDED|95.0|28.5|41.54|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F||41.54|28.50|
71073595|NCT02987972|141656098|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.74|0.94|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1||0.94|0.74|
71073596|NCT02987972|141656098|OTHER||GMC Ratio|1.93|||||TWO_SIDED|95.0|1.71|2.18|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3||2.18|1.71|
71115449|NCT01942668|141737569|SUPERIORITY||Mean Difference (Final Values)|-3.28|STANDARD_ERROR_OF_MEAN|1.653||0.047|TWO_SIDED|95.0|-6.52|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.04|-6.52|0.047
71115450|NCT01942668|141737569|SUPERIORITY||Mean Difference (Final Values)|-3.41|STANDARD_ERROR_OF_MEAN|1.652||0.039|TWO_SIDED|95.0|-6.65|-0.17||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.17|-6.65|0.039
71115451|NCT01942668|141737570|SUPERIORITY||Mean Difference (Final Values)|-5.69|STANDARD_ERROR_OF_MEAN|1.713|<|0.001|TWO_SIDED|95.0|-9.05|-2.33||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-2.33|-9.05|<0.001
71115452|NCT01942668|141737570|SUPERIORITY||Mean Difference (Final Values)|-5.58|STANDARD_ERROR_OF_MEAN|1.704||0.001|TWO_SIDED|95.0|-8.93|-2.24||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-2.24|-8.93|0.001
71073597|NCT02987972|141656098|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.9|1.14|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4||1.14|0.90|
71115453|NCT01942668|141737570|SUPERIORITY||Mean Difference (Final Values)|-5.12|STANDARD_ERROR_OF_MEAN|1.697||0.003|TWO_SIDED|95.0|-8.45|-1.79||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.79|-8.45|0.003
71073598|NCT02987972|141656098|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.72|0.94|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5||0.94|0.72|
71073599|NCT02987972|141656098|OTHER||GMC Ratio|0.57|||||TWO_SIDED|95.0|0.49|0.66|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A||0.66|0.49|
71073600|NCT02987972|141656098|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.74|1.1|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B||1.10|0.74|
71073601|NCT02987972|141656098|OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.72|0.91|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F||0.91|0.72|
71073602|NCT02987972|141656098|OTHER||GMC Ratio|1.07|||||TWO_SIDED|95.0|0.94|1.22|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V||1.22|0.94|
71073603|NCT02987972|141656098|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.71|0.97|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14||0.97|0.71|
71073604|NCT02987972|141656098|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.88|1.12|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 18C||1.12|0.88|
71073605|NCT02987972|141656098|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.73|0.92|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A||0.92|0.73|
71073606|NCT02987972|141656098|OTHER||GMC Ratio|0.91|||||TWO_SIDED|95.0|0.81|1.01|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F||1.01|0.81|
71073607|NCT02987972|141656098|OTHER||GMC Ratio|1.18|||||TWO_SIDED|95.0|1.01|1.37|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F||1.37|1.01|
71073608|NCT02987972|141656098|OTHER||GMC Ratio|80.09|||||TWO_SIDED|95.0|70.3|91.24|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 22F||91.24|70.30|
71073609|NCT02987972|141656098|OTHER||GMC Ratio|32.92|||||TWO_SIDED|95.0|27.25|39.78|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F||39.78|27.25|
71073610|NCT02987972|141656099|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-3.1|3.2||||||Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.||3.2|-3.1|
71073611|NCT02987972|141656099|OTHER||Difference in Percentages|2.0|||||TWO_SIDED|95.0|-0.7|5.0||||||Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.||5.0|-0.7|
71073612|NCT02987972|141656100|OTHER||Difference in Percentages|0.3|||||TWO_SIDED|95.0|-0.8|1.6||||||Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.||1.6|-0.8|
71073613|NCT02987972|141656100|OTHER||Difference in Percentages|0.3|||||TWO_SIDED|95.0|-0.8|1.6||||||Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.||1.6|-0.8|
71073614|NCT02987972|141656101|OTHER||Difference in Percentages|6.3|||||TWO_SIDED|95.0|-0.3|12.8|||||Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™.|||12.8|-0.3|
71073615|NCT02987972|141656101|OTHER||Difference in Percentages|6.3|||||TWO_SIDED|95.0|-0.2|12.9|||||Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™.|||12.9|-0.2|
71073616|NCT02987972|141656102|OTHER||Difference in Percentages|0.7||||0.772|TWO_SIDED|95.0|-3.9|5.2|||Miettinen and Nurminen||Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™.|||5.2|-3.9|0.772
71073617|NCT02987972|141656102|OTHER||Difference in Percentages|2.6||||0.235|TWO_SIDED|95.0|-1.7|7.0|||Miettinen and Nurminen||Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™.|||7.0|-1.7|0.235
71073618|NCT02987972|141656103|OTHER||GMC Ratio|0.69|||||TWO_SIDED|95.0|0.62|0.76|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1||0.76|0.62|
71073619|NCT02987972|141656103|OTHER||GMC Ratio|2.0|||||TWO_SIDED|95.0|1.75|2.28|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3||2.28|1.75|
71073620|NCT02987972|141656103|OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.86|1.07|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4||1.07|0.86|
71073621|NCT02987972|141656103|OTHER||GMC Ratio|0.87|||||TWO_SIDED|95.0|0.78|0.96|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5||0.96|0.78|
71073622|NCT02987972|141656103|OTHER||GMC Ratio|0.57|||||TWO_SIDED|95.0|0.5|0.65|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A||0.65|0.50|
71073623|NCT02987972|141656103|OTHER||GMC Ratio|1.21|||||TWO_SIDED|95.0|1.06|1.39|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B||1.39|1.06|
71073624|NCT02987972|141656103|OTHER||GMC Ratio|0.74|||||TWO_SIDED|95.0|0.67|0.82|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F||0.82|0.67|
71073625|NCT02987972|141656103|OTHER||GMC Ratio|0.84|||||TWO_SIDED|95.0|0.74|0.95|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V||0.95|0.74|
71073626|NCT02987972|141656103|OTHER||GMC Ratio|0.66|||||TWO_SIDED|95.0|0.58|0.76|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14||0.76|0.58|
71073627|NCT02987972|141656103|OTHER||GMC Ratio|0.8|||||TWO_SIDED|95.0|0.72|0.9||||||Type 18C|IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|0.90|0.72|
71073628|NCT02987972|141656103|OTHER||GMC Ratio|0.79|||||TWO_SIDED|95.0|0.69|0.91|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A||0.91|0.69|
71073629|NCT02987972|141656103|OTHER||GMC Ratio|0.74|||||TWO_SIDED|95.0|0.65|0.85|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F||0.85|0.65|
71073630|NCT02987972|141656103|OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.79|1.07|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F||1.07|0.79|
71073631|NCT02987972|141656103|OTHER||GMC Ratio|27.82|||||TWO_SIDED|95.0|24.64|31.4|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|type 22F||31.40|24.64|
71073632|NCT02987972|141656103|OTHER||GMC Ratio|25.57|||||TWO_SIDED|95.0|22.61|28.92|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F||28.92|22.61|
71073633|NCT02987972|141656103|OTHER||GMC ratio|0.77|||||TWO_SIDED|95.0|0.69|0.85|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1||0.85|0.69|
71073634|NCT02987972|141656103|OTHER||GMC Ratio|2.1|||||TWO_SIDED|95.0|1.84|2.39|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3||2.39|1.84|
71073635|NCT02987972|141656103|OTHER||GMC Ratio|0.94|||||TWO_SIDED|95.0|0.85|1.05|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4||1.05|0.85|
71073636|NCT02987972|141656103|OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.77|0.95|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5||0.95|0.77|
71073637|NCT02987972|141656103|OTHER||GMC Ratio|0.65|||||TWO_SIDED|95.0|0.57|0.74|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A||0.74|0.57|
71073638|NCT02987972|141656103|OTHER||GMC Ratio|1.12|||||TWO_SIDED|95.0|0.97|1.28|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B||1.28|0.97|
71073639|NCT02987972|141656103|OTHER||GMC Ratio|0.78|||||TWO_SIDED|95.0|0.7|0.86|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F||0.86|0.70|
71073640|NCT02987972|141656103|OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.76|0.97|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V||0.97|0.76|
71073641|NCT02987972|141656103|OTHER||GMC Ratio|0.61|||||TWO_SIDED|95.0|0.53|0.7|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14||0.70|0.53|
71073642|NCT02987972|141656103|OTHER||GMC Ratio|1.2|||||TWO_SIDED|95.0|1.07|1.34|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 18C||1.34|1.07|
71073643|NCT02987972|141656103|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.71|0.94|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A||0.94|0.71|
71073644|NCT02987972|141656103|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.73|0.94|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F||0.94|0.73|
71073645|NCT02987972|141656103|OTHER||GMC Ratio|1.16|||||TWO_SIDED|95.0|0.99|1.35|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F||1.35|0.99|
71073646|NCT02987972|141656103|OTHER||GMC Ratio|26.3|||||TWO_SIDED|95.0|23.31|29.68|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 22F||29.68|23.31|
71073647|NCT02987972|141656103|OTHER||GMC Ratio|24.1|||||TWO_SIDED|95.0|21.32|27.25|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F||27.25|21.32|
71073648|NCT02987972|141656104|OTHER||GMC Ratio|0.71|||||TWO_SIDED|95.0|0.62|0.81|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1||0.81|0.62|
71073649|NCT02987972|141656104|OTHER||GMC Ratio|1.44|||||TWO_SIDED|95.0|1.27|1.63|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3||1.63|1.27|
71073650|NCT02987972|141656104|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.76|1.02|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4||1.02|0.76|
71073651|NCT02987972|141656104|OTHER||GMC Ratio|0.73|||||TWO_SIDED|95.0|0.63|0.84|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5||0.84|0.63|
71073652|NCT02987972|141656104|OTHER||GMC Ratio|0.72|||||TWO_SIDED|95.0|0.62|0.82|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A||0.82|0.62|
71073653|NCT02987972|141656104|OTHER||GMC Ratio|1.07|||||TWO_SIDED|95.0|0.93|1.22|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B||1.22|0.93|
71073654|NCT02987972|141656104|OTHER||GMC Ratio|0.67|||||TWO_SIDED|95.0|0.59|0.77|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F||0.77|0.59|
71073655|NCT02987972|141656104|OTHER||GMC Ratio|0.69|||||TWO_SIDED|95.0|0.6|0.79|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V||0.79|0.60|
71073656|NCT02987972|141656104|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.76|1.02|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14||1.02|0.76|
71073657|NCT02987972|141656104|OTHER||GMC Ratio|0.93|||||TWO_SIDED|95.0|0.81|1.08|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 18C||1.08|0.81|
71073658|NCT02987972|141656104|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.78|1.01|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A||1.01|0.78|
71073659|NCT02987972|141656104|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.1|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F||1.10|0.85|
71073660|NCT02987972|141656104|OTHER||GMC Ratio|0.75|||||TWO_SIDED|95.0|0.64|0.87|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F||0.87|0.64|
71073661|NCT02987972|141656104|OTHER||GMC Ratio|149.69|||||TWO_SIDED|95.0|130.23|172.06|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 22F||172.06|130.23|
71073662|NCT02987972|141656104|OTHER||GMC Ratio|90.35|||||TWO_SIDED|95.0|79.93|102.12|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F||102.12|79.93|
71073663|NCT02987972|141656104|OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.71|0.93|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1||0.93|0.71|
71073664|NCT02987972|141656104|OTHER||GMC Ratio|1.48|||||TWO_SIDED|95.0|1.31|1.68|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3||1.68|1.31|
70940358|NCT00141271|141380804|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1483||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.1483
71073665|NCT02987972|141656104|OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.7|0.94|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4||0.94|0.70|
71073666|NCT02987972|141656104|OTHER||GMC Ratio|0.69|||||TWO_SIDED|95.0|0.6|0.79|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5||0.79|0.60|
71073667|NCT02987972|141656104|OTHER||GMC Ratio|0.66|||||TWO_SIDED|95.0|0.58|0.76|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A||0.76|0.58|
71073668|NCT02987972|141656104|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.72|0.95|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B||0.95|0.72|
71073669|NCT02987972|141656104|OTHER||GMC Ratio|0.71|||||TWO_SIDED|95.0|0.62|0.81|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F||0.81|0.62|
71073670|NCT02987972|141656104|OTHER||GMC Ratio|0.77|||||TWO_SIDED|95.0|0.67|0.88|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V||0.88|0.67|
71073671|NCT02987972|141656104|OTHER||GMC Ratio|0.85|||||TWO_SIDED|95.0|0.73|0.98|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14||0.98|0.73|
71115454|NCT01942668|141737570|SUPERIORITY||Mean Difference (Final Values)|-5.11|STANDARD_ERROR_OF_MEAN|1.708||0.003|TWO_SIDED|95.0|-8.46|-1.76||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.76|-8.46|0.003
71115455|NCT01942668|141737571|SUPERIORITY||Mean Difference (Final Values)|-6.01|STANDARD_ERROR_OF_MEAN|1.885||0.001|TWO_SIDED|95.0|-9.71|-2.32||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.32|-9.71|0.001
71115456|NCT01942668|141737571|SUPERIORITY||Mean Difference (Final Values)|-7.22|STANDARD_ERROR_OF_MEAN|1.871|<|0.001|TWO_SIDED|95.0|-10.89|-3.55||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.55|-10.89|<0.001
71073672|NCT02987972|141656104|OTHER||GMC Ratio|1.07|||||TWO_SIDED|95.0|0.93|1.24|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 18C||1.24|0.93|
71073673|NCT02987972|141656104|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.72|0.93|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A||0.93|0.72|
71073674|NCT02987972|141656104|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.79|1.03|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F||1.03|0.79|
71073675|NCT02987972|141656104|OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.79|1.08|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F||1.08|0.79|
71073676|NCT02987972|141656104|OTHER||GMC Ratio|131.23|||||TWO_SIDED|95.0|114.05|151.0|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 22F||151.00|114.05|
71073677|NCT02987972|141656104|OTHER||GMC Ratio|78.99|||||TWO_SIDED|95.0|69.82|89.36|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F||89.36|69.82|
71073678|NCT05365958|141656155|SUPERIORITY||||||<|0.001|||||||Repeated Measures t-test of differences|||||||<.001
71073679|NCT05365958|141656156|SUPERIORITY||||||<|0.001|||||||Repeated Measures t-test of differences|||||||<.001
71073680|NCT04676412|141656163|OTHER|Percent difference and 95% CI were calculated using Miettinen and Nurminen method with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 status (1-49% versus ≥50%).|Difference in percentage|-8.4||||0.79262|TWO_SIDED|95.0|-27.4|11.9|||Stratified Miettinen and Nurminen|One-sided p-value for testing. H0: difference in percentage =0 versus H1: difference in percentage \> 0||||11.9|-27.4|0.79262
71073681|NCT04676412|141656166|OTHER|Difference in LS means and 95% CI were calculated using the Constrained longitudinal data analysis (cLDA) model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1) and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in Least Square (LS) Means|-0.25||||0.9519|TWO_SIDED|95.0|-8.59|8.09|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG and baseline PDL-1.||||8.09|-8.59|0.9519
71115457|NCT01942668|141737571|SUPERIORITY||Mean Difference (Final Values)|-6.92|STANDARD_ERROR_OF_MEAN|1.863|<|0.001|TWO_SIDED|95.0|-10.58|-3.27||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.27|-10.58|<0.001
71115458|NCT01942668|141737571|SUPERIORITY||Mean Difference (Final Values)|-6.42|STANDARD_ERROR_OF_MEAN|1.886|<|0.001|TWO_SIDED|95.0|-10.12|-2.72||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.72|-10.12|<0.001
70940359|NCT00141271|141380804|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0674||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.0674
70940360|NCT00141271|141380804|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.2900
71073682|NCT04676412|141656167|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1) and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS Means|8.81||||0.0628|TWO_SIDED|95.0|-0.49|18.11|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG and baseline PDL-1.||||18.11|-0.49|0.0628
71073683|NCT04676412|141656168|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1) and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS Means|3.59||||0.3298|TWO_SIDED|95.0|-3.7|10.87|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG and baseline PDL-1.||||10.87|-3.70|0.3298
71073684|NCT04676412|141656169|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1) and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS Means|-0.28||||0.9594|TWO_SIDED|95.0|-11.32|10.75|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG and baseline PDL-1.||||10.75|-11.32|0.9594
71073685|NCT04676412|141656170|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1) and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS Means|-5.53||||0.162|TWO_SIDED|95.0|-13.37|2.31|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG and baseline PDL-1.||||2.31|-13.37|0.1620
71073686|NCT04676412|141656171|OTHER|HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1) and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|1.03||||0.9419|TWO_SIDED|95.0|0.47|2.26|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status and baseline PD-L1 status.||||2.26|0.47|0.9419
71073687|NCT04676412|141656172|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1) and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|1.01||||0.9789|TWO_SIDED|95.0|0.43|2.38|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status and baseline PD-L1 status.||||2.38|0.43|0.9789
71073688|NCT04676412|141656173|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1) and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|1.08||||0.8856|TWO_SIDED|95.0|0.36|3.28|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status and baseline PD-L1 status.||||3.28|0.36|0.8856
71073689|NCT04676412|141656174|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1) and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|1.55||||0.3264|TWO_SIDED|95.0|0.64|3.75|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status and baseline PD-L1 status.||||3.75|0.64|0.3264
71073690|NCT04676412|141656175|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1) and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|1.31||||0.4068|TWO_SIDED|95.0|0.7|2.46|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status and baseline PD-L1 status.||||2.46|0.70|0.4068
71073691|NCT04676412|141656176|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1) and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|7.81||||0.002|TWO_SIDED|95.0|1.71|35.62|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status and baseline PD-L1 status.||||35.62|1.71|0.0020
71115459|NCT01942668|141737572|SUPERIORITY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.609||0.004|TWO_SIDED|95.0|-7.75|-1.44||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.44|-7.75|0.004
71115460|NCT01942668|141737572|SUPERIORITY||Mean Difference (Final Values)|-3.49|STANDARD_ERROR_OF_MEAN|1.605||0.03|TWO_SIDED|95.0|-6.64|-0.34||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.34|-6.64|0.030
71115461|NCT01942668|141737572|SUPERIORITY||Mean Difference (Final Values)|-3.15|STANDARD_ERROR_OF_MEAN|1.598||0.049|TWO_SIDED|95.0|-6.29|-0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.02|-6.29|0.049
71115462|NCT01942668|141737572|SUPERIORITY||Mean Difference (Final Values)|-2.48|STANDARD_ERROR_OF_MEAN|1.597||0.121|TWO_SIDED|95.0|-5.61|0.65||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.65|-5.61|0.121
71115463|NCT01942668|141737573|SUPERIORITY||Mean Difference (Final Values)|-5.44|STANDARD_ERROR_OF_MEAN|1.682||0.001|TWO_SIDED|95.0|-8.74|-2.14||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-2.14|-8.74|0.001
70940361|NCT00141271|141380804|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5482||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.5482
71115464|NCT01942668|141737573|SUPERIORITY||Mean Difference (Final Values)|-5.53|STANDARD_ERROR_OF_MEAN|1.674|<|0.001|TWO_SIDED|95.0|-8.81|-2.25||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-2.25|-8.81|<0.001
70853449|NCT00095147|141195017|SUPERIORITY_OR_OTHER||Difference from placebo (PCS)|3.32||||0.002|TWO_SIDED|95.0|1.25|5.4|||ANCOVA|||Adjusted mean change in SF-36 physical component summary from baseline to 6 months (Day 197) was compared between INF and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||5.40|1.25|0.002
71073692|NCT04676412|141656177|OTHER|Hazard ratio (HR) and 95% confidence interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|1.18||||0.71084|TWO_SIDED|95.0|0.61|2.25|||Stratified Log Rank|One-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of enrolling site and baseline PD-L1 status.||||2.25|0.61|0.71084
71073693|NCT04676412|141656178|OTHER||Hazard Ratio (HR)|1.53||||0.8197|TWO_SIDED|95.0|0.61|3.87|||Stratified Log Rank|One-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of enrolling site and baseline PD-L1 status.||HR and 95% CIs were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 status (1-49% versus ≥50%).||3.87|0.61|0.81970
71073694|NCT04765722|141656193|SUPERIORITY||% change relative to placebo|18.0||||0.99|TWO_SIDED|95.0|-46.4|160.1||The model included treatment group, week, the interaction between treatment group and week, and baseline log-transformed 24-hour cough frequency as fixed effects.|Generalized estimating equations|Hypothesis tests were two-sided, a p\<0.05 indicated statistical significance. We made no adjustments for multiple comparisons across outcomes.||The primary outcome was the change from baseline in log-transformed 24-hour cough frequency (coughs/hour) at week 14.||160.1|-46.4|0.99
71073695|NCT05175131|141656207|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.0042|TWO_SIDED|95.0|0.3|1.8|||ANCOVA||Mean difference of Mebeverine+Simethicone combination to Mebeverine. Adjusted least squares mean (difference between Mebeverine+Simethicone combination and Mebeverine) from ANCOVA is presented here|ANCOVA was used for primary end point analysis. The model included the change from baseline of the NRS\_11 score as dependent variable and treatment and site as independent factors, and baseline NRS-11 as covariate.||1.8|0.3|0.0042
71073696|NCT05175131|141656207|SUPERIORITY||Mean Difference (Final Values)|1.6|||<|0.0001|TWO_SIDED|95.0|0.9|2.4|||ANCOVA||Adjusted least squares mean (difference between Mebeverine+Simethicone combination and Mebeverine) from ANCOVA is presented here|Mean difference of Mebeverine+Simethicone combination to Simethicone. ANCOVA was used for primary end point analysis. The model included the change from baseline of the NRS\_11 score as dependent variable and treatment and site as independent factors, and baseline NRS-11 as covariate.||2.4|0.9|<0.0001
71073697|NCT02542293|141656214|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0808|TWO_SIDED|95.0|0.485|1.045||The 2-sided p-value was calculated using an unstratified log-rank test.|Log Rank||The HR and confidence interval (CI) were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"Global: Durvalumab + Tremelimumab versus (Vs) Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.045|0.485|0.0808
71073698|NCT02542293|141656215|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.322|1.109|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.109|0.322|
71073699|NCT02542293|141656216|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.629|1.201|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥16 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.201|0.629|
71073700|NCT02542293|141656216|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.726|1.213|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.213|0.726|
71073701|NCT02542293|141656216|SUPERIORITY||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.786|1.464|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 negative analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.464|0.786|
71073702|NCT02542293|141656216|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.835|1.302|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB \<20 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.302|0.835|
71115465|NCT01942668|141737573|SUPERIORITY||Mean Difference (Final Values)|-5.12|STANDARD_ERROR_OF_MEAN|1.667||0.002|TWO_SIDED|95.0|-8.39|-1.85||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.85|-8.39|0.002
71115466|NCT01942668|141737573|SUPERIORITY||Mean Difference (Final Values)|-4.64|STANDARD_ERROR_OF_MEAN|1.677||0.006|TWO_SIDED|95.0|-7.93|-1.35||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.35|-7.93|0.006
71115467|NCT01942668|141737574|SUPERIORITY||Mean Difference (Final Values)|-6.28|STANDARD_ERROR_OF_MEAN|1.849|<|0.001|TWO_SIDED|95.0|-9.91|-2.65||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.65|-9.91|<0.001
71073703|NCT02542293|141656216|SUPERIORITY||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.758|1.353|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB non-evaluable analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.353|0.758|
70853450|NCT00095147|141195017|SUPERIORITY_OR_OTHER||Difference from placebo (MCS)|2.68||||0.027|TWO_SIDED|95.0|0.31|5.05|||ANCOVA|||Adjusted mean change in SF-36 mental component summary from baseline to 6 months (Day 197) was compared between INF and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||5.05|0.31|0.027
70853451|NCT02390791|141195081|SUPERIORITY|||||||0.04|||||||generalized linear model|assuming a Poisson distribution with a log link function||||||0.04
70853452|NCT02390791|141195082|SUPERIORITY|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
70853453|NCT02390791|141195083|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||||||0.85
70853454|NCT02390791|141195084|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
70853455|NCT02390791|141195085|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
70853456|NCT02390791|141195086|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||||||0.94
70853457|NCT02390791|141195087|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
70853458|NCT02390791|141195088|SUPERIORITY|||||||0.15|||||||Chi-squared|||||||0.15
70853459|NCT02390791|141195089|SUPERIORITY|||||||0.48|||||||generalized linear model|||||||0.48
70853460|NCT02390791|141195090|SUPERIORITY|||||||0.71|||||||generalized linear model|||||||0.71
70853461|NCT01375075|141195091|SUPERIORITY_OR_OTHER||LS Mean Difference|92.61|STANDARD_ERROR_OF_MEAN|9.04|<|0.001|TWO_SIDED|90.0|77.65|107.57||The P-value is for percent change from baseline in HDL-C at Week 2.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||107.57|77.65|<0.001
70853462|NCT01375075|141195091|SUPERIORITY_OR_OTHER||LS Mean Difference|106.17|STANDARD_ERROR_OF_MEAN|10.69|<|0.001|TWO_SIDED|90.0|88.47|123.87||The P-value is for percent change from baseline in HDL-C at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||123.87|88.47|<0.001
70853463|NCT01375075|141195091|SUPERIORITY_OR_OTHER||LS Mean Difference|103.66|STANDARD_ERROR_OF_MEAN|11.18|<|0.001|TWO_SIDED|90.0|85.14|122.17||The P-value is for percent change from baseline in HDL-C at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||122.17|85.14|<0.001
70853464|NCT01375075|141195091|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.46|STANDARD_ERROR_OF_MEAN|4.39|<|0.001|TWO_SIDED|90.0|-24.73|-10.19||The P-value is for percent change from baseline in LDL-C at Week 2.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-10.19|-24.73|<0.001
70853465|NCT01375075|141195091|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.39|STANDARD_ERROR_OF_MEAN|4.4||0.019|TWO_SIDED|90.0|-17.67|-3.11||The P-value is for percent change from baseline in LDL-C at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-3.11|-17.67|0.019
70853466|NCT01375075|141195091|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.26|STANDARD_ERROR_OF_MEAN|4.77||0.011|TWO_SIDED|90.0|-20.17|-4.36||The P-value is for percent change from baseline in LDL-C at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-4.36|-20.17|0.011
70853467|NCT01375075|141195094|SUPERIORITY_OR_OTHER||LS Mean Difference|3.74|STANDARD_ERROR_OF_MEAN|2.5||0.136|TWO_SIDED|90.0|-0.39|7.88||The P-value is for change from baseline in SBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||7.88|-0.39|0.136
70853468|NCT01375075|141195094|SUPERIORITY_OR_OTHER||LS Mean Difference|2.83|STANDARD_ERROR_OF_MEAN|2.48||0.257|TWO_SIDED|90.0|-1.28|6.94||The P-value is for change from baseline in SBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||6.94|-1.28|0.257
70853469|NCT01375075|141195094|SUPERIORITY_OR_OTHER||LS Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|2.54||0.021|TWO_SIDED|90.0|1.7|10.1||The P-value is for change from baseline in SBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||10.10|1.70|0.021
70853470|NCT01375075|141195094|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|2.52||0.829|TWO_SIDED|90.0|-4.71|3.62||The P-value is for change from baseline in SBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.62|-4.71|0.829
70853471|NCT01375075|141195094|SUPERIORITY_OR_OTHER||LS Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|1.5||0.603|TWO_SIDED|90.0|-1.69|3.24||The P-value is for change from baseline in DBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.24|-1.69|0.603
70853472|NCT01375075|141195094|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|1.48||0.656|TWO_SIDED|90.0|-3.11|1.78||The P-value is for change from baseline in DBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.78|-3.11|0.656
71073704|NCT02542293|141656216|SUPERIORITY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.309|1.008|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥14 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.008|0.309|
71115468|NCT01942668|141737574|SUPERIORITY||Mean Difference (Final Values)|-7.58|STANDARD_ERROR_OF_MEAN|1.835|<|0.001|TWO_SIDED|95.0|-11.18|-3.98||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.98|-11.18|<0.001
71115469|NCT01942668|141737574|SUPERIORITY||Mean Difference (Final Values)|-7.43|STANDARD_ERROR_OF_MEAN|1.828|<|0.001|TWO_SIDED|95.0|-11.02|-3.84||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.84|-11.02|<0.001
71115470|NCT01942668|141737574|SUPERIORITY||Mean Difference (Final Values)|-6.54|STANDARD_ERROR_OF_MEAN|1.851|<|0.001|TWO_SIDED|95.0|-10.17|-2.91||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.91|-10.17|<0.001
71115471|NCT01942668|141737575|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.049||0.225|TWO_SIDED|95.0|-0.04|0.16||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.16|-0.04|0.225
71115472|NCT01942668|141737575|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.049||0.741|TWO_SIDED|95.0|-0.08|0.11||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.11|-0.08|0.741
71115473|NCT01942668|141737575|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.049||0.414|TWO_SIDED|95.0|-0.06|0.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.14|-0.06|0.414
71115474|NCT01942668|141737575|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.049||0.69|TWO_SIDED|95.0|-0.11|0.08||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.08|-0.11|0.690
71115475|NCT01942668|141737576|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.052||0.045|TWO_SIDED|95.0|0.0|0.21||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.21|0.00|0.045
71115476|NCT01942668|141737576|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.052||0.069|TWO_SIDED|95.0|-0.01|0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.20|-0.01|0.069
71115477|NCT01942668|141737576|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.052||0.126|TWO_SIDED|95.0|-0.02|0.18||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.18|-0.02|0.126
71115478|NCT01942668|141737576|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.052||0.907|TWO_SIDED|95.0|-0.1|0.11||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.11|-0.10|0.907
71115479|NCT01942668|141737577|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.055||0.992|TWO_SIDED|95.0|-0.11|0.11||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.11|-0.11|0.992
71115480|NCT01942668|141737577|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.054||0.45|TWO_SIDED|95.0|-0.07|0.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.15|-0.07|0.450
71115481|NCT01942668|141737577|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.054||0.663|TWO_SIDED|95.0|-0.13|0.08||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.08|-0.13|0.663
71115482|NCT01942668|141737577|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.055||0.309|TWO_SIDED|95.0|-0.16|0.05||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.05|-0.16|0.309
71115483|NCT03497975|141737636|SUPERIORITY||Odds Ratio (OR)|2.1||||0.0309|TWO_SIDED|95.0|1.07|4.13||Logistic regression model includes WI-NRS baseline score as a covariate, treatment and the study site (with pooling) as a fixed effect.|Regression, Logistic|||||4.13|1.07|0.0309
71115484|NCT03497975|141737637|SUPERIORITY||Difference in LS Mean|-7.06|STANDARD_ERROR_OF_MEAN|1.91||0.0002|TWO_SIDED|95.0|-10.82|-3.3||Repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline ItchyQoL value. An unstructured covariance matrix is used.|Mixed Model for Repeated Measurements|||||-3.30|-10.82|0.0002
70940362|NCT00141271|141380804|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0303||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.0303
71115485|NCT03497975|141737638|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0179|TWO_SIDED|95.0|1.11|3.07||Logistic regression model includes PAS (Item 5a) baseline score as a covariate, treatment as a fixed effect and the study site (with pooling) as a fixed effect.|Regression, Logistic|||||3.07|1.11|0.0179
71115486|NCT03497975|141737639|SUPERIORITY||Difference in LS Mean|-4.43|STANDARD_ERROR_OF_MEAN|1.08|<|0.0001|TWO_SIDED|95.0|-6.55|-2.31||Repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline PROMIS value. An unstructured covariance matrix is used.|Mixed Model for Repeated Measurements|||||-2.31|-6.55|<0.0001
71115487|NCT01257230|141737648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|STANDARD_ERROR_OF_MEAN|0.051||0.0085|TWO_SIDED|95.0|0.034|0.234|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.234|0.034|0.0085
71115488|NCT01257230|141737648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.05||0.0005|TWO_SIDED|95.0|0.076|0.272|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.272|0.076|0.0005
71115489|NCT01257230|141737649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.056||0.1307|TWO_SIDED|95.0|-0.025|0.194|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.194|-0.025|0.1307
71115490|NCT01257230|141737649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.054||0.032|TWO_SIDED|95.0|0.01|0.223|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.223|0.010|0.0320
70940363|NCT00141271|141380804|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6143||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.6143
71115491|NCT01257230|141737650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.057||0.1231|TWO_SIDED|95.0|-0.024|0.2|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.200|-0.024|0.1231
71115492|NCT01257230|141737650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.072|STANDARD_ERROR_OF_MEAN|0.056||0.195|TWO_SIDED|95.0|-0.037|0.182|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.182|-0.037|0.1950
71115493|NCT01257230|141737651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.06||0.2921|TWO_SIDED|95.0|-0.055|0.181|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.181|-0.055|0.2921
71115494|NCT01257230|141737651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.059||0.5495|TWO_SIDED|95.0|-0.08|0.15|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.150|-0.080|0.5495
71115495|NCT01257230|141737652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.049||0.0079|TWO_SIDED|95.0|0.034|0.225|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.225|0.034|0.0079
71115496|NCT01257230|141737652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.181|STANDARD_ERROR_OF_MEAN|0.048||0.0002|TWO_SIDED|95.0|0.088|0.275|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.275|0.088|0.0002
71115497|NCT01257230|141737653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.054||0.0945|TWO_SIDED|95.0|-0.016|0.196|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.196|-0.016|0.0945
71115498|NCT01257230|141737653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.071|STANDARD_ERROR_OF_MEAN|0.053||0.1755|TWO_SIDED|95.0|-0.032|0.175|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.175|-0.032|0.1755
71115499|NCT01257230|141737655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.092||0.976|TWO_SIDED|95.0|-0.184|0.178|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.178|-0.184|0.9760
71115500|NCT01257230|141737655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.009|STANDARD_ERROR_OF_MEAN|0.09||0.9224|TWO_SIDED|95.0|-0.186|0.168|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.168|-0.186|0.9224
71115501|NCT01257230|141737656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.083||0.7852|TWO_SIDED|95.0|-0.14|0.185|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.185|-0.140|0.7852
71115502|NCT01257230|141737656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.081||0.1649|TWO_SIDED|95.0|-0.046|0.271|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.271|-0.046|0.1649
71115503|NCT01257230|141737657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.032|STANDARD_ERROR_OF_MEAN|0.143||0.8253|TWO_SIDED|95.0|-0.312|0.249|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.249|-0.312|0.8253
71115504|NCT01257230|141737657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.14||0.7559|TWO_SIDED|95.0|-0.232|0.319|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.319|-0.232|0.7559
71115505|NCT01257230|141737658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.087||0.0653|TWO_SIDED|95.0|-0.33|0.01|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.010|-0.330|0.0653
71115506|NCT01257230|141737658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.097|STANDARD_ERROR_OF_MEAN|0.084||0.2516|TWO_SIDED|95.0|-0.263|0.069|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.069|-0.263|0.2516
71115507|NCT01257230|141737660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.147|STANDARD_ERROR_OF_MEAN|0.095||0.12|TWO_SIDED|95.0|-0.333|0.038|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.038|-0.333|0.1200
71115508|NCT01257230|141737660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.092||0.5589|TWO_SIDED|95.0|-0.235|0.127|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.127|-0.235|0.5589
71115509|NCT01257230|141737662|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63||||0.4023|TWO_SIDED|95.0|0.21|1.87|||Regression, Cox|||||1.87|0.21|0.4023
71115510|NCT01257230|141737662|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.23||||0.062|TWO_SIDED|95.0|0.05|1.08|||Regression, Cox|||||1.08|0.05|0.0620
71115511|NCT01257230|141737663|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.87|TWO_SIDED|95.0|0.65|1.66|||Regression, Cox|||||1.66|0.65|0.8700
71115512|NCT01257230|141737663|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.4198|TWO_SIDED|95.0|0.51|1.33|||Regression, Cox|||||1.33|0.51|0.4198
71115513|NCT01988662|141737685|NON_INFERIORITY_OR_EQUIVALENCE|"H0: There is no difference in the percent change in VEGF level after 3 months for patients with nAMD treated with ranibizumab compared to aflibercept.~HA: There is a difference in the percent change in VEGF level after 3 months for patients with nAMD treated with ranibizumab compared to aflibercept."|Mean Difference (Net)|62.57|STANDARD_ERROR_OF_MEAN|24.639||0.012|TWO_SIDED|95.0|13.96|111.17|||Mixed Models Analysis|||H0: μR = μA versus HA: μR ≠ μA||111.17|13.96|0.012
71115514|NCT03070171|141737689|EQUIVALENCE|Bioequivalence was established by ensuring that the T/R ratio of AUC0-tz of free dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|108.46909|||||TWO_SIDED|90.0|101.44605|115.97833|||ANOVA||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'.||115.97833|101.44605|
71115515|NCT03070171|141737690|EQUIVALENCE|Bioequivalence was established by ensuring that the T/R ratio of Cmax of free dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|108.9587|||||TWO_SIDED|90.0|101.78627|116.63654|||ANOVA||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'.||116.63654|101.78627|
71117705|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-4.94||||0.31|TWO_SIDED|95.0|-14.34|4.46||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.46|-14.34|0.310
71115516|NCT03070171|141737691|EQUIVALENCE|Bioequivalence was established by ensuring that the T/R ratio of Cmax of free dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|107.61507|||||TWO_SIDED|90.0|100.61938|115.09714|||ANOVA||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'.||115.09714|100.61938|
71115517|NCT03070171|141737692|EQUIVALENCE|Bioequivalence was established by ensuring that the T/R ratio of Cmax of total dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|106.69566|||||TWO_SIDED|90.0|99.50139|114.4101|||ANOVA||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'.||114.41010|99.50139|
71115518|NCT03070171|141737693|EQUIVALENCE|Bioequivalence was established by ensuring that the T/R ratio of AUC0-∞ of total dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|107.83324|||||TWO_SIDED|90.0|101.25584|114.8379|||ANOVA||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'.||114.83790|101.25584|
71115519|NCT03070171|141737694|EQUIVALENCE|Bioequivalence was established by ensuring that the T/R ratio of AUC0-∞ of free dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|108.43158|||||TWO_SIDED|90.0|101.87254|115.41292|||ANOVA||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'.||115.41292|101.87254|
71115520|NCT01471028|141737697|SUPERIORITY||Hazard Ratio (HR)|1.027||||0.904|TWO_SIDED|95.0|0.689|1.53|||Log Rank|||The primary endpoint was assessed using a Kaplan-Meier survival analysis of the Intent-to-treat (ITT) population utilizing a log-rank test.||1.53|0.689|0.904
71115521|NCT01471028|141737698|SUPERIORITY|||||||0.737|||||||Chi-squared|||||||0.737
71115522|NCT01471028|141737699|SUPERIORITY||Hazard Ratio (HR)|1.315||||0.168|TWO_SIDED|95.0|0.886|1.952|||Log Rank|||||1.952|0.886|0.168
71115523|NCT01471028|141737700|SUPERIORITY||Hazard Ratio (HR)|0.283||||0.007|TWO_SIDED|95.0|0.109|0.732|||Log Rank|||||0.732|0.109|0.007
71115524|NCT04445519|141737743|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the 95.1% CIs around the difference (NCX 470 minus latanoprost 0.005%) in mean IOP reduction from time-matched baseline in the study eye was greater than or equal to -1.5 mmHg at all time points and was greater than or equal to -1.0 mmHg at a majority of the time points.|Mean Difference (Net)|1.0|STANDARD_DEVIATION|3.25|||TWO_SIDED|95.1||||The primary efficacy assessment was the non-inferiority analysis of the difference in the treatment effect between NCX 470 and latanoprost 0.005% for mean IOP reduction from time-matched baseline at the 8AM and 4PM time-points.|||The analysis assumed a true difference of 1.0 mmHg at the Week 2 time points and 1.25 mmHg at the Week 6 and Month 3 time points; a common standard deviation (SD) at each time-point of 3.25 mmHg; and a two-sided significance level of 4.9%.|||||
71115525|NCT00177294|141737768|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Regression, Logistic|||We conducted Cox regreassion analyses of time to remission and logistic modeling for rates of remission. We tested group difference in Hamilton depession ratings over time via mixed-effects modeling.||||0.14
71115526|NCT05352412|141737774|OTHER|Mann-Whitney U|Mann-Whitney U|0.32||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.32
71115527|NCT05352412|141737774|OTHER|Mann-Whitney U|Mann-Whitney U|0.39||||0.39|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline survey compared with immediate follow-up survey||||0.39
71115528|NCT05352412|141737774|OTHER|Mann-Whitney U|Mann-Whitney U|0.21||||0.21|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2 weeks post-discharge compared with baseline survey||||0.21
71115529|NCT05352412|141737774|OTHER||Mann-Whitney U|0.19||||0.19|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||90 days post-discharge compared with baseline survey||||0.19
71115530|NCT05352412|141737774|OTHER||Mann-Whitney U|0.38||||0.38|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline survey versus immediate follow-up||||0.38
71115531|NCT05352412|141737774|OTHER||Mann-Whitney U|0.25||||0.25|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2 weeks post-discharge compared with baseline survey||||0.25
71115532|NCT05352412|141737774|OTHER||Mann-Whitney U|0.07||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||90 days post-discharge compared with baseline survey||||0.07
71115533|NCT05352412|141737774|OTHER||Mann-Whitney U|0.03||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up between the two arms||||0.03
71115534|NCT05352412|141737774|OTHER||Mann-Whitney U|0.65||||0.65|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2 weeks post-discharge comparison between the 2 arms||||0.65
71115535|NCT05352412|141737774|OTHER||Mann-Whitney U|0.97||||0.97|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||90-days post discharge compared between the 2 arms||||0.97
71115536|NCT05352412|141737775|OTHER||Mann-Whitney U|0.77||||0.77|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline comparison between the 2 arms||||0.77
71115537|NCT05352412|141737775|OTHER||Mann-Whitney U|0.85||||0.85|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up compared with baseline survey||||0.85
71115538|NCT05352412|141737775|OTHER||Mann-Whitney U|0.38||||0.38|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2-week post-discharge compared with baseline survey||||0.38
71115539|NCT05352412|141737775|OTHER||Mann-Whitney U|0.21||||0.21|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||90-day post discharge compared with baseline survey||||0.21
71115540|NCT05352412|141737775|OTHER||Mann-Whitney U|0.32||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up compared with baseline survey||||0.32
71115541|NCT05352412|141737775|OTHER||Mann-Whitney U|0.09||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2 week post-discharge compared with baseline survey||||0.09
71115542|NCT05352412|141737775|OTHER||Mann-Whitney U|0.07||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||90-day post-discharge compared with baseline survey||||0.07
71115543|NCT05352412|141737775|OTHER||Mann-Whitney U|0.26||||0.26|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2 weeks post-discharge compared between the 2 arms||||0.26
71115544|NCT05352412|141737775|OTHER||Mann-Whitney U|0.69||||0.69|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up compared between the 2 arms||||0.69
71115545|NCT05352412|141737775|OTHER||Mann-Whitney U|0.32||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||90-day post-discharge compared between the 2 arms||||0.32
70940364|NCT00141271|141380804|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3385||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.3385
71115546|NCT05352412|141737779|OTHER|Mann-Whitney U|Mann-Whitney U|1.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.00
71115547|NCT05352412|141737779|OTHER|Mann-Whitney U|Mann-Whitney U|1.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.00
71115548|NCT05352412|141737779|OTHER|Mann-Whitney U|Mann-Whitney U|0.12||||0.12|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.12
71115549|NCT05352412|141737779|OTHER|Mann-Whitney U|Mann-Whitney U|0.12||||0.12|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up||||0.12
71115550|NCT05352412|141737780|OTHER|Mann-Whitney U|Mann-Whitney U|0.48||||0.48|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.48
71115551|NCT05352412|141737780|OTHER|Mann-Whitney U|Mann-Whitney U|1.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.00
71115552|NCT05352412|141737780|OTHER|Mann-Whitney U|Mann-Whitney U|0.17||||0.17|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.17
71115553|NCT05352412|141737780|OTHER|Mann-Whitney U|Mann-Whitney U|0.42||||0.42|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up||||0.42
71115554|NCT05352412|141737781|OTHER|Mann-Whitney U|Mann-Whitney U|1.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline||||1.00
71115555|NCT05352412|141737781|OTHER|Mann-Whitney U|Mann-Whitney U|0.11||||0.11|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline versus immediate follow-up||||0.11
71115556|NCT05352412|141737781|OTHER|Mann-Whitney U|Mann-Whitney U|0.89||||0.89|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline versus immediate follow-up||||0.89
71115557|NCT05352412|141737781|OTHER|Mann-Whitney U|Mann-Whitney U|0.55||||0.55|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up||||0.55
71115558|NCT05352412|141737782|OTHER|Mann-Whitney U|Mann-Whitney U|0.66||||0.66|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline||||0.66
71115559|NCT05352412|141737782|OTHER|Mann-Whitney U|Mann-Whitney U|0.2||||0.2|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline versus immediate follow-up post randomization||||0.20
71115560|NCT05352412|141737782|OTHER|Mann-Whitney U|Mann-Whitney U|0.85||||0.85|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline versus immediate follow-up post randomization||||0.85
71115561|NCT05352412|141737782|OTHER|Mann-Whitney U|Mann-Whitney U|0.07||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up post randomization||||0.07
71115562|NCT06359028|141737783|SUPERIORITY||Adjusted Mean Difference|-1.94|STANDARD_ERROR_OF_MEAN|0.113|<|0.0001|TWO_SIDED|95.0|-2.16|-1.72|||Mixed Model with Repeated Measures|||||-1.72|-2.16|<0.0001
71115563|NCT06359028|141737784|SUPERIORITY||Adjusted Mean Difference|57.37|STANDARD_ERROR_OF_MEAN|3.599|<|0.0001|TWO_SIDED|95.0|50.23|64.51|||Mixed Model with Repeated Measures|||||64.51|50.23|<0.0001
71115564|NCT06359028|141737785|SUPERIORITY||Adjusted Mean Difference|-1.65|STANDARD_ERROR_OF_MEAN|0.121|<|0.0001|TWO_SIDED|95.0|-1.89|-1.41|||Mixed Model with Repeated Measures|||||-1.41|-1.89|<0.0001
71115565|NCT06359028|141737786|SUPERIORITY||Adjusted Mean Difference|35.37|STANDARD_ERROR_OF_MEAN|4.28|<|0.0001|TWO_SIDED|95.0|26.88|43.86|||Mixed Model with Repeated Measures|||||43.86|26.88|<0.0001
71115566|NCT06359028|141737787|SUPERIORITY||Adjusted Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.296||0.1268|TWO_SIDED|95.0|-1.04|0.13|||Mixed Model with Repeated Measures|||Q7, Day 28||0.13|-1.04|0.1268
71115567|NCT06359028|141737787|SUPERIORITY||Adjusted Mean Difference|-1.75|STANDARD_ERROR_OF_MEAN|0.316|<|0.0001|TWO_SIDED|95.0|-2.38|-1.13|||Mixed Model with Repeated Measures|||Q7, Day 56||-1.13|-2.38|<0.0001
71115568|NCT06359028|141737787|SUPERIORITY||Adjusted Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.315||0.0245|TWO_SIDED|95.0|-1.35|-0.09|||Mixed Model with Repeated Measures|||Q8, Day 28||-0.09|-1.35|0.0245
71115569|NCT06359028|141737787|SUPERIORITY||Adjusted Mean Difference|-1.81|STANDARD_ERROR_OF_MEAN|0.318|<|0.0001|TWO_SIDED|95.0|-2.44|-1.18|||Mixed Model with Repeated Measures|||Q8, Day 56||-1.18|-2.44|<0.0001
71115570|NCT06359028|141737787|SUPERIORITY||Adjusted Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.337||0.3851|TWO_SIDED|95.0|-0.96|0.37|||Mixed Model with Repeated Measures|||Q9, Day 28||0.37|-0.96|0.3851
71115571|NCT06359028|141737787|SUPERIORITY||Adjusted Mean Difference|-1.48|STANDARD_ERROR_OF_MEAN|0.375||0.0002|TWO_SIDED|95.0|-2.22|-0.73|||Mixed Model with Repeated Measures|||Q9, Day 56||-0.73|-2.22|0.0002
71115572|NCT06359028|141737788|SUPERIORITY||Adjusted Mean Difference|-6.19|STANDARD_ERROR_OF_MEAN|4.674||0.1884|TWO_SIDED|95.0|-15.46|3.08|||Mixed Model with Repeated Measures|||Day 28||3.08|-15.46|0.1884
71115573|NCT06359028|141737788|SUPERIORITY||Adjusted Mean Difference|-24.49|STANDARD_ERROR_OF_MEAN|6.308||0.0002|TWO_SIDED|95.0|-37.0|-11.97|||Mixed Model with Repeated Measures|||Day 56||-11.97|-37.00|0.0002
71115574|NCT06359028|141737789|SUPERIORITY||Adjusted Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.774||0.3003|TWO_SIDED|95.0|-2.34|0.73|||Mixed Model with Repeated Measures|||Day 28||0.73|-2.34|0.3003
71115575|NCT06359028|141737789|SUPERIORITY||Adjusted Mean Difference|-2.77|STANDARD_ERROR_OF_MEAN|0.903||0.0028|TWO_SIDED|95.0|-4.56|-0.97|||Mixed Model with Repeated Measures|||Day 56||-0.97|-4.56|0.0028
71115576|NCT06359028|141737790|SUPERIORITY||Adjusted Mean Difference|-3.78|STANDARD_ERROR_OF_MEAN|2.127||0.0784|TWO_SIDED|95.0|-8.0|0.44|||Mixed Model with Repeated Measures|||Day 28||0.44|-8.00|0.0784
71115577|NCT06359028|141737790|SUPERIORITY||Adjusted Mean Difference|-8.17|STANDARD_ERROR_OF_MEAN|3.074||0.0092|TWO_SIDED|95.0|-14.27|-2.07|||Mixed Model with Repeated Measures|||Day 56||-2.07|-14.27|0.0092
71115578|NCT06359028|141737791|SUPERIORITY||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.846||0.8686|TWO_SIDED|95.0|-1.82|1.54|||Mixed Model with Repeated Measures|||Day 28||1.54|-1.82|0.8686
71115579|NCT06359028|141737791|SUPERIORITY||Adjusted Mean Difference|-3.24|STANDARD_ERROR_OF_MEAN|0.976||0.0012|TWO_SIDED|95.0|-5.18|-1.31|||Mixed Model with Repeated Measures|||Day 56||-1.31|-5.18|0.0012
71115580|NCT06359028|141737792|SUPERIORITY||Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|1.444||0.9047|TWO_SIDED|95.0|-3.04|2.69|||Mixed Model with Repeated Measures|||Day 28||2.69|-3.04|0.9047
71115581|NCT06359028|141737792|SUPERIORITY||Adjusted Mean Difference|-6.66|STANDARD_ERROR_OF_MEAN|1.656||0.0001|TWO_SIDED|95.0|-9.95|-3.38|||Mixed Model with Repeated Measures|||Day 56||-3.38|-9.95|0.0001
71115582|NCT06359028|141737793|SUPERIORITY||Adjusted Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.84||0.5733|TWO_SIDED|95.0|-2.14|1.19|||Mixed Model with Repeated Measures|||Day 28||1.19|-2.14|0.5733
71115583|NCT06359028|141737793|SUPERIORITY||Adjusted Mean Difference|-2.88|STANDARD_ERROR_OF_MEAN|1.026||0.006|TWO_SIDED|95.0|-4.92|-0.84|||Mixed Model with Repeated Measures|||Day 56||-0.84|-4.92|0.0060
71115584|NCT06359028|141737794|SUPERIORITY||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.127||0.2768|TWO_SIDED|95.0|-0.39|0.11|||Mixed Model with Repeated Measures|||Day 28||0.11|-0.39|0.2768
71115585|NCT06359028|141737794|SUPERIORITY||Adjusted Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.113||0.0232|TWO_SIDED|95.0|-0.48|-0.04|||Mixed Model with Repeated Measures|||Day 56||-0.04|-0.48|0.0232
71115586|NCT06359028|141737795|SUPERIORITY||Adjusted Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.403||0.8996|TWO_SIDED|95.0|-0.75|0.85|||Mixed Model with Repeated Measures|||Day 28||0.85|-0.75|0.8996
71115587|NCT06359028|141737795|SUPERIORITY||Adjusted Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.383||0.0204|TWO_SIDED|95.0|-1.66|-0.14|||Mixed Model with Repeated Measures|||Day 56||-0.14|-1.66|0.0204
71115588|NCT00661726|141737802|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||<0.01
71115589|NCT00661726|141737804|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.045
71115590|NCT00661726|141737805|SUPERIORITY_OR_OTHER|||||||0.083||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.083
71115591|NCT00661726|141737806|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.039
71115592|NCT00661726|141737807|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.18
71115593|NCT00661726|141737808|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||<0.01
71115594|NCT00661726|141737809|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.069
71115595|NCT00661726|141737810|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.18
71115596|NCT00661726|141737811|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.022
71115597|NCT00661726|141737812|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.11
71115598|NCT00661726|141737813|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||<0.01
71115599|NCT03088930|141737815|OTHER||Summary statistics|0.0|||||TWO_SIDED|||||||||Three subjects enrolled. No statistical analysis completed due to low accrual.|Three subjects enrolled. No statistical analysis completed due to low accrual.|||
71115600|NCT01716039|141737827|OTHER|Comparing the change in the modified Baron score from baseline to week 18 between the treatment groups||||||0.758|||||||Wilcoxon (Mann-Whitney)|||||||0.758
71115601|NCT01716039|141737827|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
71115602|NCT01716039|141737828|OTHER|||||||0.908||||||p-value for the overall treatment difference is based on an analysis of covariance adjusting for baseline UCEIS|ANCOVA|||||||0.908
71115603|NCT03215758|141737863|SUPERIORITY||Mean Difference (Net)|0.0238||||0.088|TWO_SIDED|95.0|-0.006|0.088|||ANCOVA|||||0.088|-0.006|0.088
71115604|NCT03215758|141737864|SUPERIORITY||Mean Difference (Net)|-0.06||||0.278|TWO_SIDED|95.0|-0.16|0.05|||ANCOVA|||||0.05|-0.16|0.278
71073705|NCT02542293|141656216|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.56|1.35|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.350|0.560|
71073706|NCT02542293|141656216|SUPERIORITY||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.614|1.251|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥10 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.251|0.614|
71073707|NCT02542293|141656216|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.564|1.08|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥8 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.080|0.564|
71073708|NCT02542293|141656217|SUPERIORITY||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.871|1.186|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (≥25% Vs \<25%), smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by Efron approach.|"FAS:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.186|0.871|
71073709|NCT02542293|141656217|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.48|1.018|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>= 25% Vs \< 25 and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"FAS:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.018|0.480|
71073710|NCT02542293|141656217|SUPERIORITY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.654|1.078|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥25% analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.078|0.654|
71073711|NCT02542293|141656217|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.289|1.065|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥ 25% analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.065|0.289|
71073712|NCT02542293|141656217|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.587|1.081|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥50% analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.081|0.587|
71073713|NCT02542293|141656217|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.222|0.955|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥50% analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||0.955|0.222|
71073714|NCT02542293|141656218|SUPERIORITY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.514|1.146|||||The HR and CI interval were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥20 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.146|0.514|
71073715|NCT02542293|141656218|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.623|1.189|||||The HR and CI interval were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥16 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.189|0.623|
71073716|NCT02542293|141656218|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.714|1.193|||||The HR and CI interval were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.193|0.714|
71073717|NCT02542293|141656218|SUPERIORITY||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.258|0.818|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥14 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||0.818|0.258|
71073718|NCT02542293|141656218|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.524|1.228|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.228|0.524|
71115605|NCT03215758|141737865|SUPERIORITY||Mean Difference (Net)|-0.08||||0.429|TWO_SIDED|95.0|-0.3|0.13|||ANCOVA|||||0.13|-0.30|0.429
71115606|NCT03215758|141737866|SUPERIORITY||Mean Difference (Net)|0.069||||0.777|TWO_SIDED|95.0|-0.12|0.15|||ANCOVA|||||0.15|-0.12|0.777
71073719|NCT02542293|141656218|SUPERIORITY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.585|1.177|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥10 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.177|0.585|
71073720|NCT02542293|141656218|SUPERIORITY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.534|1.017|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥8 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.017|0.534|
71073721|NCT02542293|141656219|SUPERIORITY||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.81|1.517|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1-negative analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.517|0.810|
71073722|NCT02542293|141656219|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.592|2.141|||||The HR and CI interval were calculated using an stratified Cox proportional hazards model, adjusting histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1-negative analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||2.141|0.592|
71073723|NCT02542293|141656219|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.924|1.253|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (≥25% Vs \<25%), smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by Efron approach.|"FAS:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.253|0.924|
71073724|NCT02542293|141656219|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.655|1.362|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (≥ 25% Vs \< 25%) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"FAS:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.362|0.655|
71073725|NCT02542293|141656219|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.621|1.024|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥25% analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.024|0.621|
71073726|NCT02542293|141656219|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.389|1.317|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥ 25% analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.317|0.389|
70940365|NCT00141271|141380805|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3299||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.3299
71115607|NCT04115748|141737867|SUPERIORITY||Difference in response rates|32.1||||0.048|TWO_SIDED|95.0|2.6|61.6||The stratification factors (Geographic Region, Concurrent Use of conventional synthetic (cs) DMARD(s) and/or Apremilast at Randomization, Prior Use of biologic (bio) DMARD(s)) and treatment groups were included in the imputation model as covariates.|Multiple imputation method|||||61.6|2.6|0.048
71115608|NCT04115748|141737867|SUPERIORITY||Difference in response rates|18.4||||0.23|TWO_SIDED|95.0|-12.4|49.2||The stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) and treatment groups were included in the imputation model as covariates.|Multiple imputation method|||||49.2|-12.4|0.23
71115609|NCT04115748|141737869|SUPERIORITY||Difference in response rates|16.1||||0.17|TWO_SIDED|95.0|-9.7|41.9||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||41.9|-9.7|0.17
70940366|NCT00141271|141380805|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1915||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1915
70940367|NCT00141271|141380806|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5407||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.5407
70940368|NCT00141271|141380806|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6079||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.6079
70940369|NCT00141271|141380807|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8464||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.8464
70940370|NCT00141271|141380807|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4023||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.4023
71115610|NCT04115748|141737869|SUPERIORITY||Difference in response rates|11.7||||0.27|TWO_SIDED|95.0|-13.3|36.6||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||36.6|-13.3|0.27
70940371|NCT00141271|141380807|SUPERIORITY_OR_OTHER_LEGACY|||||||0.287||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.2870
70940372|NCT00141271|141380807|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2537||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.2537
70940373|NCT00141271|141380807|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7909||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7909
70940374|NCT00141271|141380807|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3308||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.3308
71073727|NCT02542293|141656219|SUPERIORITY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.542|1.01|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥50% analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.010|0.542|
70940375|NCT00141271|141380808|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3355||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.3355
71073728|NCT02542293|141656219|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.335|1.251|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥50% analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.251|0.335|
71073729|NCT02542293|141656220|SUPERIORITY||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.236|1.03||||||"bTMB ≥20 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.030|0.236|
71073730|NCT02542293|141656220|SUPERIORITY||Odds Ratio (OR)|0.53|||||TWO_SIDED|95.0|0.288|0.968||||||"bTMB ≥16 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||0.968|0.288|
71073731|NCT02542293|141656220|SUPERIORITY||Odds Ratio (OR)|0.55|||||TWO_SIDED|95.0|0.336|0.908||||||"bTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||0.908|0.336|
71073732|NCT02542293|141656220|SUPERIORITY||Odds Ratio (OR)|1.96|||||TWO_SIDED|95.0|0.752|5.234||||||"tTMB ≥14 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||5.234|0.752|
71073733|NCT02542293|141656220|SUPERIORITY||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.482|2.214||||||"tTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||2.214|0.482|
71115611|NCT04115748|141737869|SUPERIORITY||Difference in response rates|10.5||||0.42|TWO_SIDED|95.0|-20.4|41.5||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||41.5|-20.4|0.42
71115612|NCT04115748|141737869|SUPERIORITY||Difference in response rates|15.8||||0.26|TWO_SIDED|95.0|-16.0|47.6||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||47.6|-16.0|0.26
71115613|NCT04115748|141737869|SUPERIORITY||Difference in response rates|28.7||||0.062|TWO_SIDED|95.0|-5.0|62.3||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||62.3|-5.0|0.062
71073734|NCT02542293|141656220|SUPERIORITY||Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.43|1.548||||||"tTMB ≥10 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.548|0.430|
71115614|NCT04115748|141737869|SUPERIORITY||Difference in response rates|31.6||||0.047|TWO_SIDED|95.0|-1.5|64.6||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||64.6|-1.5|0.047
71073735|NCT02542293|141656220|SUPERIORITY||Odds Ratio (OR)|0.83|||||TWO_SIDED|95.0|0.456|1.486||||||"tTMB ≥8 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.486|0.456|
70853473|NCT01375075|141195094|SUPERIORITY_OR_OTHER||LS Mean Difference|1.83|STANDARD_ERROR_OF_MEAN|1.52||0.228|TWO_SIDED|90.0|-0.67|4.34||The P-value is for change from baseline in DBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||4.34|-0.67|0.228
70853474|NCT01375075|141195094|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|1.51||0.516|TWO_SIDED|90.0|-3.47|1.51||The P-value is for change from baseline in DBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.51|-3.47|0.516
71073736|NCT02542293|141656221|SUPERIORITY||Odds Ratio (OR)|0.47|||||TWO_SIDED|95.0|0.245|0.869|||||The analysis was performed using logistic regression, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"PD-L1-negative analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||0.869|0.245|
71073737|NCT02542293|141656221|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Odds Ratio (OR)|0.42|||||TWO_SIDED|95.0|0.124|1.337|||Binomial exact test|||"PD-L1-negative analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.337|0.124|
71073738|NCT02542293|141656221|SUPERIORITY||Odds Ratio (OR)|0.48|||||TWO_SIDED|95.0|0.356|0.647|||||The analysis was performed using logistic regression adjusting for PD-L1 status (≥25% Vs \<25%), smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"FAS:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||0.647|0.356|
71073739|NCT02542293|141656221|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.45|1.66|||||The analysis was performed using logistic regression, adjusting for PD-L1 status (\>= 25% Vs \< 25%), smoking status (never smoker Va ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"FAS:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.660|0.450|
71073740|NCT02542293|141656221|SUPERIORITY||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.443|1.079|||||The analysis was performed using logistic regression, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"PD-L1 TC ≥25% analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.079|0.443|
71073741|NCT02542293|141656221|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Odds Ratio (OR)|1.78|||||TWO_SIDED|95.0|0.658|4.919|||||The analysis was performed using logistic regression, adjusting for PD-L1 status (\>= 25% Vs \< 25%), smoking status (never smoker Va ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"PD-L1 TC ≥ 25% analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||4.919|0.658|
70940376|NCT00141271|141380808|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8447||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.8447
70940377|NCT00141271|141380808|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8959||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.8959
71073742|NCT02542293|141656221|SUPERIORITY||Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.449|1.291|||||The analysis was performed using logistic regression, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"PD-L1 TC ≥50% analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.291|0.449|
71073743|NCT02542293|141656221|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Odds Ratio (OR)|1.73|||||TWO_SIDED|95.0|0.585|5.27|||||The analysis was performed using logistic regression, adjusting for PD-L1 status (\>= 25% Vs \< 25%), smoking status (never smoker Va ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"PD-L1 TC ≥50% analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||5.270|0.585|
70940378|NCT00141271|141380808|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4826||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.4826
70940379|NCT00141271|141380808|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4178||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4178
70940380|NCT00141271|141380808|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8277||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.8277
71115615|NCT04115748|141737869|SUPERIORITY||Difference in response rates|7.8||||0.58|TWO_SIDED|95.0|-24.6|40.2||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||40.2|-24.6|0.58
70853475|NCT01375075|141195095|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|1.11||0.513|TWO_SIDED|90.0|-2.57|1.11|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.11|-2.57|0.513
71073744|NCT02542293|141656222|SUPERIORITY||Hazard Ratio (HR)|0.25|||||TWO_SIDED|95.0|0.113|0.532|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥20 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||0.532|0.113|
71073745|NCT02542293|141656222|SUPERIORITY||Hazard Ratio (HR)|0.36|||||TWO_SIDED|95.0|0.196|0.639|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥16 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||0.639|0.196|
71073746|NCT02542293|141656222|SUPERIORITY||Hazard Ratio (HR)|0.38|||||TWO_SIDED|95.0|0.233|0.611|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||0.611|0.233|
71073747|NCT02542293|141656223|SUPERIORITY||Hazard Ratio (HR)|0.41|||||TWO_SIDED|95.0|0.199|0.787|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1-negative analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||0.787|0.199|
71073748|NCT02542293|141656223|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.183|2.86|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1-negative analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||2.860|0.183|
71073749|NCT02542293|141656223|SUPERIORITY||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.324|0.588|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"FAS:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||0.588|0.324|
71073750|NCT02542293|141656223|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.39|||||TWO_SIDED|95.0|0.193|0.761|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>= 25% Vs \< 25%) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"FAS:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||0.761|0.193|
71073751|NCT02542293|141656226|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.494|1.058|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥20 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.058|0.494|
71073752|NCT02542293|141656226|SUPERIORITY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.607|1.151|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥16 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.151|0.607|
71073753|NCT02542293|141656226|SUPERIORITY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.689|1.146|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.146|0.689|
71073754|NCT02542293|141656227|SUPERIORITY||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.748|1.388|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1-negative analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.388|0.748|
71115616|NCT04115748|141737869|SUPERIORITY||Difference in response rates|16.8||||0.27|TWO_SIDED|95.0|-16.2|49.9||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||49.9|-16.2|0.27
71115617|NCT04115748|141737870|SUPERIORITY||Difference in response rates|5.3|||||TWO_SIDED|95.0|-9.9|20.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||20.4|-9.9|
71115618|NCT04115748|141737870|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-5.3|5.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||5.3|-5.3|
71115619|NCT04115748|141737870|SUPERIORITY||Difference in response rates|-5.3|||||TWO_SIDED|95.0|-27.6|17.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||17.1|-27.6|
71073755|NCT02542293|141656227|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.36|1.219|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1-negative analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.219|0.360|
71073756|NCT02542293|141656227|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.845|1.147|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>= 25% Vs \< 25%), smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by Efron approach.|"FAS:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.147|0.845|
71073757|NCT02542293|141656227|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.492|1.03|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"FAS:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.030|0.492|
71073758|NCT00310466|141656236|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||ANOVA|||||||0.87
71073759|NCT00310466|141656237|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||||||0.04
71073760|NCT00310466|141656239|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||ANOVA|||||||0.55
71073761|NCT01458951|141656240|SUPERIORITY_OR_OTHER||Percentage difference|13.0||||0.0005|TWO_SIDED|95.0|8.1|17.9|||CMH Chi-square Test|||P-value based on Cochran-Mantel Haenszel (CMH) chi-square test stratified by prior treatment with anti-tumor necrosis factor (TNF), steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using non-responder imputation (NRI).||17.9|8.1|0.0005
71073762|NCT01458951|141656241|SUPERIORITY_OR_OTHER||Percentage difference|16.8||||0.0002|TWO_SIDED|95.0|9.5|24.1|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||24.1|9.5|0.0002
71073763|NCT01458951|141656242|SUPERIORITY_OR_OTHER||Percentage difference|26.4|||<|0.0001|TWO_SIDED|95.0|16.8|36.0|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||36.0|16.8|<0.0001
71073764|NCT01458951|141656243|SUPERIORITY_OR_OTHER||Percentage difference|5.2||||0.0425|TWO_SIDED|95.0|1.8|8.6|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||8.6|1.8|0.0425
71073765|NCT01458951|141656244|SUPERIORITY_OR_OTHER||Difference in percentage|13.2||||0.0004|TWO_SIDED|95.0|8.3|18.1|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference in its percentage and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||18.1|8.3|0.0004
71073766|NCT01458951|141656245|SUPERIORITY_OR_OTHER||Percentage difference|8.0||||0.009|TWO_SIDED|95.0|3.9|12.2|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||12.2|3.9|0.0090
71073767|NCT01458951|141656246|SUPERIORITY_OR_OTHER||Percentage difference|3.3||||0.1408|TWO_SIDED|95.0|0.1|6.6|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||6.6|0.1|0.1408
71073768|NCT01458951|141656248|SUPERIORITY_OR_OTHER||Least square mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.4|-0.6|||Mixed Models Analysis|||At Week 2: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and subjects as a random effect.||-0.6|-1.4|<0.0001
71115620|NCT04115748|141737870|SUPERIORITY||Difference in response rates|-10.5|||||TWO_SIDED|95.0|-29.6|8.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||8.5|-29.6|
71115621|NCT04115748|141737870|SUPERIORITY||Difference in response rates|5.8|||||TWO_SIDED|95.0|-17.2|28.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||28.9|-17.2|
71115622|NCT04115748|141737870|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-19.5|19.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||19.5|-19.5|
71115623|NCT04115748|141737870|SUPERIORITY||Difference in response rates|5.6|||||TWO_SIDED|95.0|-10.3|21.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||21.4|-10.3|
71115624|NCT04115748|141737870|SUPERIORITY||Difference in response rates|10.5|||||TWO_SIDED|95.0|-8.4|29.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||29.5|-8.4|
71115625|NCT04115748|141737876|SUPERIORITY||Difference in response rates|16.1|||||TWO_SIDED|95.0|-9.7|41.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||41.9|-9.7|
70853476|NCT01375075|141195095|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|1.12||0.97|TWO_SIDED|90.0|-1.82|1.9|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.90|-1.82|0.970
71073769|NCT01458951|141656248|SUPERIORITY_OR_OTHER||Least square mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.6|-0.7|||Mixed Models Analysis|||At Week 4: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and subjects as a random effect.||-0.7|-1.6|<0.0001
71073770|NCT01458951|141656248|SUPERIORITY_OR_OTHER||Least square mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.7|-0.9|||Mixed Models Analysis|||At Week 8: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and subjects as a random effect.||-0.9|-1.7|<0.0001
71073771|NCT01458951|141656249|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.2|-1.0|||ANCOVA|||The change from baseline at Week 8 was analyzed using an analysis of covariance (ANCOVA) model with treatment group, prior treatment with anti-TNF, steroid use at baseline and geographic region as factors and baseline as a covariate based on the observed-case data.||-1.0|-2.2|<0.0001
71073772|NCT00585013|141656250|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||This p value applies to all time points for all variables.|Wilcoxon (Mann-Whitney)|||||||>0.05
71115626|NCT04115748|141737876|SUPERIORITY||Difference in response rates|6.1|||||TWO_SIDED|95.0|-16.5|28.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||28.8|-16.5|
71115627|NCT04115748|141737876|SUPERIORITY||Difference in response rates|23.9|||||TWO_SIDED|95.0|-8.8|56.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||56.6|-8.8|
71115628|NCT04115748|141737876|SUPERIORITY||Difference in response rates|27.1|||||TWO_SIDED|95.0|-5.2|59.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||59.4|-5.2|
71115629|NCT04115748|141737877|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-5.1|5.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||5.1|-5.1|
71115630|NCT04115748|141737877|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-5.3|5.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||5.3|-5.3|
71115631|NCT04115748|141737877|SUPERIORITY||Difference in response rates|11.7|||||TWO_SIDED|95.0|-13.3|36.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||36.6|-13.3|
71115632|NCT04115748|141737877|SUPERIORITY||Difference in response rates|5.5|||||TWO_SIDED|95.0|-16.4|27.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||27.4|-16.4|
71115633|NCT04115748|141737878|SUPERIORITY||Difference in response rates|15.8||||0.2|TWO_SIDED|95.0|-13.6|45.2||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||45.2|-13.6|0.20
71073773|NCT00585013|141656251|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||This applies for measurements at preoperative and 0 h time points.|Wilcoxon (Mann-Whitney)|||||||>0.05
71073774|NCT00585013|141656251|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||This applies to measurements at time points 12 h, 24 h, and 48 h.|Wilcoxon (Mann-Whitney)|||||||<0.05
71073775|NCT00585013|141656252|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||This applies to measurements at preoperative, 0 h, and 48 h time points.|Wilcoxon (Mann-Whitney)|||||||>0.05
71073776|NCT00585013|141656252|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||This applies to time points at 12 h and 24 h.|Wilcoxon (Mann-Whitney)|||||||<0.05
71073777|NCT00585013|141656253|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Applies to all time points.|Wilcoxon (Mann-Whitney)|||||||>0.05
71115634|NCT04115748|141737878|SUPERIORITY||Difference in response rates|-5.0||||0.6|TWO_SIDED|95.0|-27.8|17.8||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||17.8|-27.8|0.60
71115635|NCT04115748|141737878|SUPERIORITY||Difference in response rates|42.6||||0.008|TWO_SIDED|95.0|11.5|73.8||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||73.8|11.5|0.008
71115636|NCT04115748|141737878|SUPERIORITY||Difference in response rates|17.8||||0.17|TWO_SIDED|95.0|-12.0|47.6||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||47.6|-12.0|0.17
71115637|NCT04115748|141737878|SUPERIORITY||Difference in response rates|42.1||||0.011|TWO_SIDED|95.0|8.1|76.2||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||76.2|8.1|0.011
71115638|NCT04115748|141737878|SUPERIORITY||Difference in response rates|5.3||||0.69|TWO_SIDED|95.0|-30.1|40.6||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||40.6|-30.1|0.69
71115639|NCT04115748|141737878|SUPERIORITY||Difference in response rates|35.7||||0.033|TWO_SIDED|95.0|0.9|70.4||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||70.4|0.9|0.033
71115640|NCT04115748|141737878|SUPERIORITY||Difference in response rates|21.1||||0.19|TWO_SIDED|95.0|-15.2|57.4||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||57.4|-15.2|0.19
71115641|NCT04115748|141737878|SUPERIORITY||Difference in response rates|43.9||||0.007|TWO_SIDED|95.0|12.4|75.4||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||75.4|12.4|0.007
71115642|NCT04115748|141737878|SUPERIORITY||Difference in response rates|7.6||||0.63|TWO_SIDED|95.0|-28.8|44.1||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||44.1|-28.8|0.63
71115643|NCT04115748|141737879|SUPERIORITY||Difference in response rates|0.0||||0.98|TWO_SIDED|95.0|-19.5|19.5||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||19.5|-19.5|0.98
71115644|NCT04115748|141737879|SUPERIORITY||Difference in response rates|-5.3||||0.5|TWO_SIDED|95.0|-20.7|10.2||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||10.2|-20.7|0.50
71115645|NCT04115748|141737879|SUPERIORITY||Difference in response rates|5.5||||0.54|TWO_SIDED|95.0|-16.4|27.4||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||27.4|-16.4|0.54
70853477|NCT01375075|141195095|SUPERIORITY_OR_OTHER||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|1.16||0.824|TWO_SIDED|90.0|-1.66|2.17|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.17|-1.66|0.824
70940381|NCT00141271|141380809|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7758||||||For all efficacy analyses, no multiple comparisons adjustments were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.7758
70940382|NCT00141271|141380809|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8737||||||For all efficacy analyses, no multiple comparisons adjustments were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.8737
70940383|NCT00141271|141380809|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1151||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.1151
70940384|NCT00141271|141380809|SUPERIORITY_OR_OTHER_LEGACY|||||||0.129||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.1290
70940385|NCT00141271|141380809|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4432||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4432
71073778|NCT03309696|141656276|EQUIVALENCE|A p value of \<.0.05 is taken as evidence of nonequivalence.|Mean Difference (Net)|-0.59||||0.055|TWO_SIDED|||||The p value is not adjusted because it was a planned contrast.|Mixed Models Analysis||Active tDCS - sham tDCS.|Examines the effect of tDCS preconditioning on P100 amplitudes. The effect size for this comparison was .33 (Cohen's).||||.055
71073779|NCT03309696|141656276|EQUIVALENCE|A p value of \<.05 is taken as evidence of nonequivalence.|Mean Difference (Net)|0.36||||0.0418|TWO_SIDED|||||This p value is not adjusted for multiple comparisons because it was a planned contrast.|Mixed Models Analysis||Sham tDCS - Sham tDCS and Active rTMS|Examines the effect of rTMS on the P100 amplitude. The calculated effect size is .35 (Cohen's).||||0.0418
71073780|NCT03309696|141656276|EQUIVALENCE|A p value less than 0.05 is taken as evidence of nonequivalence.|Mean Difference (Net)|-0.19||||0.4|TWO_SIDED|||||The p value is not adjusted as this was a planned contrast.|Mixed Models Analysis||Effect of tDCS preconditioning on active rTMS: active tDCS preconditioning of active rTMS - sham tDCS preconditioning of active rTMS.|Examines the additive effect of tDCS preconditioning on the P100 amplitude after rTMS. The effect size for this comparison was 0.14.||||0.40
71073781|NCT03309696|141656276|EQUIVALENCE|A p value less than 0.05 is taken as evidence of nonequivalence.|Mean Difference (Net)|-0.48||||0.086|TWO_SIDED|||||The p value was not adjusted for this planned contrast.|Mixed Models Analysis||Active tDCS and Active rTMS - Sham tDCS and Sham rTMS.|Examines the combined effect of tDCS and rTMS on the P100 amplitude. The effect size for this comparison was .29 (Cohen's).||||.086
71073782|NCT01573767|141656277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4||||0.227|TWO_SIDED|95.0|-2.7|11.4||Inference for VI 12.5 µg versus (vs) placebo was dependent upon statistical significance (SS) having first been achieved for VI 25 µg vs placebo; inference for VI 6.25 µg vs placebo was dependent on SS having been achieved for VI 12.5 µg vs placebo.|ANCOVA|||||11.4|-2.7|0.227
71073783|NCT01573767|141656277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4||||0.073|TWO_SIDED|95.0|-0.6|13.5|||ANCOVA|||||13.5|-0.6|0.073
71073784|NCT01573767|141656277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5||||0.127|TWO_SIDED|95.0|-1.6|12.5|||ANCOVA|||||12.5|-1.6|0.127
71073785|NCT01573767|141656278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.057|||||TWO_SIDED|95.0|-0.138|0.024||||||||0.024|-0.138|
71073786|NCT01573767|141656278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.017|||||TWO_SIDED|95.0|-0.063|0.096||||||||0.096|-0.063|
71073787|NCT01573767|141656278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.11|0.051||||||||0.051|-0.110|
71073788|NCT01573767|141656279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3|||||TWO_SIDED|95.0|-10.5|6.0||||||||6.0|-10.5|
71073789|NCT01573767|141656279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-6.9|9.6||||||||9.6|-6.9|
71073790|NCT01573767|141656279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.7|||||TWO_SIDED|95.0|0.4|17.0||||||||17.0|0.4|
71073791|NCT01573767|141656280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5|||||TWO_SIDED|95.0|-1.2|12.3||||||||12.3|-1.2|
71073792|NCT01573767|141656280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.5|||||TWO_SIDED|95.0|0.7|14.2||||||||14.2|0.7|
70940386|NCT00141271|141380809|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2988||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.2988
70940387|NCT00141271|141380810|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8598||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.8598
71073793|NCT01573767|141656280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.2||||||95.0|0.4|14.0||||||||14.0|0.4|
71073794|NCT01573767|141656281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5|||||TWO_SIDED|95.0|-6.1|13.1||||||||13.1|-6.1|
71073795|NCT01573767|141656281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|-1.8|17.4||||||||17.4|-1.8|
71073796|NCT01573767|141656281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.2|||||TWO_SIDED|95.0|-4.4|14.9||||||||14.9|-4.4|
71073797|NCT01573767|141656282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9|||||TWO_SIDED|95.0|-3.7|15.6||||||||15.6|-3.7|
71073798|NCT01573767|141656282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7|||||TWO_SIDED|95.0|0.0|19.3||||||||19.3|0.0|
71073799|NCT01573767|141656282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0||||||95.0|-2.7|16.7||||||||16.7|-2.7|
71073800|NCT01573767|141656283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-7.2|7.5||||||||7.5|-7.2|
71073801|NCT01573767|141656283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.3|||||TWO_SIDED|95.0|1.0|15.7||||||||15.7|1.0|
71073802|NCT01573767|141656283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.8|||||TWO_SIDED|95.0|2.3|17.2||||||||17.2|2.3|
70940388|NCT00141271|141380810|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6513||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.6513
70940389|NCT00141271|141380810|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6272||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.6272
70940390|NCT00141271|141380810|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6467||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.6467
70940391|NCT00141271|141380810|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8049||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.8049
71073803|NCT02368210|141656284|SUPERIORITY||||||<|0.001||||||"Treatment groups were compared with respect to the proportions of subjects with treatment success at Day 15 using the Cochran-Mantel-Haenszel (CMH) test stratified by analysis center."|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||||||<0.001
71073804|NCT02368210|141656285|SUPERIORITY||||||<|0.001||||||The pre-specified threshold for statistical significance was ≤0.05. The reported P-Value applies to the clinical sign of psoriasis: Scaling.|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).||||<0.001
71073805|NCT02368210|141656285|SUPERIORITY||||||<|0.001||||||The pre-specified threshold for statistical significance was ≤0.05. The reported P-Value applies to the clinical sign of psoriasis: erythema.|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).||||<0.001
71073806|NCT02368210|141656285|SUPERIORITY||||||<|0.001||||||The pre-specified threshold for statistical significance was ≤0.05. The reported P-Value applies to the clinical sign of psoriasis: Plaque Elevation.|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).||||<0.001
71073807|NCT00078949|141656290|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The literature has suggested that the ORR is approximately 50% for this patient population treated with DHAP. The treatment difference is defined as the response rate for the DHAP arm minus that of GDP arm. We would consider GDP to be non-inferior to DHAP if we are 95% sure that the true difference is less than 10%. In order to rule out that the 10% difference with 80% power, we need to accrue a total of 630 eligible patients. The actual sample size for this final analysis is 619 patients.|Risk Difference (RD)|-1.2||||0.005|TWO_SIDED|95.0|-9.0|6.7||p-value for non-inferiority|Cochran-Mantel-Haenszel|||||6.7|-9.0|0.005
71073808|NCT00078949|141656291|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-2.1||||0.55||95.0|-10.0|5.8|||Cochran-Mantel-Haenszel|||||5.8|-10.0|0.55
71073809|NCT00078949|141656292|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.17|TWO_SIDED|95.0|0.52|1.12|||Log Rank|||It was estimated that 240 patients will be eligible for the maintenance question, and randomized with a 1:1 ratio to either rituximab or observation. It is expected that the 2-year event-free survival will be 50% on the observation arm. In order to detect a 15% difference in the 2-year event-free survival with an 80% power using a two-sided 5% level test, 142 events are required to detect an HR of 0.622.||1.12|0.52|0.17
71115646|NCT04115748|141737879|SUPERIORITY||Difference in response rates|0.6||||0.92|TWO_SIDED|95.0|-19.0|20.1||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||20.1|-19.0|0.92
71115647|NCT04115748|141737879|SUPERIORITY||Difference in response rates|21.1||||0.13|TWO_SIDED|95.0|-9.3|51.4||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||51.4|-9.3|0.13
71073810|NCT03747302|141656333|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||.003
71073811|NCT03747302|141656334|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||Change in mean scores for behavioral intent to vaccine: negative values: smaller values indicate more likely to vaccinate.||||>.05
70853478|NCT01375075|141195095|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|1.12||0.769|TWO_SIDED|90.0|-2.18|1.52|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.52|-2.18|0.769
71115648|NCT04115748|141737879|SUPERIORITY||Difference in response rates|15.8||||0.22|TWO_SIDED|95.0|-13.6|45.2||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||45.2|-13.6|0.22
71115649|NCT04115748|141737879|SUPERIORITY||Difference in response rates|45.0||||0.007|TWO_SIDED|95.0|12.8|77.2||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||77.2|12.8|0.007
71115650|NCT04115748|141737879|SUPERIORITY||Difference in response rates|31.6||||0.039|TWO_SIDED|95.0|0.2|63.0||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||63.0|0.2|0.039
70940392|NCT00141271|141380810|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9411||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.9411
71073812|NCT02635542|141656350|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.00
71073813|NCT02635542|141656351|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
71073814|NCT01432275|141656352|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Binomial test|Comparison to 27 participants that preferred their usual method to FreeStyle InsuLinx. Twelve(12) participants did not have a preference.||||||<0.0001
71073815|NCT01935700|141656372|NON_INFERIORITY|Non-inferiority was defined as no statistically significant difference (P value \> 0.05) in median survival between the colchicine group and the sorafenib treated group.||||||0.4593|||||||Mann-Whitney U test|||||||0.4593
71073816|NCT01935700|141656372|NON_INFERIORITY|Non-inferiority was defined as no statistically significant difference (P value \> 0.05) in survival between the colchicine group and the sorafenib treated group.||||||0.329|||||||Log Rank|||||||0.3290
71073817|NCT01935700|141656373|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.0552||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of pneumonia between two groups||||0.0552
71073818|NCT01935700|141656373|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.0184||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of biliary tract obstruction between two groups||||0.0184
71073819|NCT01935700|141656373|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.0931||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of cholangitis between two groups||||0.0931
70853479|NCT01375075|141195096|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.33||0.735|TWO_SIDED|90.0|-0.65|0.43|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.43|-0.65|0.735
71073820|NCT01935700|141656373|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.0506||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of peritonitis between two groups||||0.0506
71073821|NCT01935700|141656373|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of sepsis between two groups||||1
71073822|NCT01935700|141656373|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.5374||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of diarrhea between two groups||||0.5374
71073823|NCT01935700|141656373|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.14||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of anorexia between two groups||||0.14
71073824|NCT01935700|141656373|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.4584||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of abdominal pain between two groups||||0.4584
71073825|NCT01935700|141656373|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of skin rash between two groups||||1
71073826|NCT01935700|141656373|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of palmar-plantar erythrodysesthesia syndrome between two groups||||1
71073827|NCT01935700|141656373|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of hypertension between two groups||||1
71073828|NCT01935700|141656373|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.5958||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of hemorrhage between two groups||||0.5958
71073829|NCT01935700|141656373|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.14||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of hypoglycemia between two groups||||0.14
71073830|NCT01935700|141656373|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of hyperglycemia between two groups||||1
71073831|NCT01935700|141656373|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of hypocalcemia between two groups||||1
71073832|NCT01935700|141656373|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of pleural effusion between two groups||||1
71073833|NCT01225289|141656374|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.01
70853480|NCT01375075|141195096|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.33||0.503|TWO_SIDED|90.0|-0.32|0.76|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.76|-0.32|0.503
71073834|NCT03019003|141656378|OTHER||||||<|0.036|||||||t-test, 2 sided|||||||<0.036
71073835|NCT02124759|141656382|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|Paired T-test||Null hypothesis is that high fat diet will have no effect on M value, the measure of insulin sensitivity for each intervention as assessed by clamp.||||>0.05
71073836|NCT04250298|141656410|OTHER|||||||0.031|||||||t-test, 2 sided|||||||0.031
71073837|NCT04250298|141656411|OTHER|||||||0.267|||||||t-test, 2 sided|||||||0.267
71073838|NCT04250298|141656412|OTHER|||||||0.228|||||||t-test, 2 sided|||||||0.228
71073839|NCT04250298|141656413|OTHER|||||||0.267|||||||t-test, 2 sided|||||||0.267
71073840|NCT04250298|141656414|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
71073841|NCT04250298|141656415|OTHER|||||||0.318|||||||Fisher Exact|||||||0.318
71073842|NCT04250298|141656416|OTHER|||||||0.348|||||||Fisher Exact|||||||0.348
71073843|NCT04250298|141656417|OTHER|||||||0.548|||||||Wilcoxon (Mann-Whitney)|||||||0.548
71073844|NCT04250298|141656418|OTHER|||||||0.401|||||||Wilcoxon (Mann-Whitney)|||||||0.401
71073845|NCT04250298|141656419|OTHER|||||||0.506|||||||Wilcoxon (Mann-Whitney)|||||||0.506
71073846|NCT04250298|141656420|OTHER|||||||0.506|||||||Wilcoxon (Mann-Whitney)|||||||0.506
71073847|NCT04250298|141656426|OTHER|Mann-Whitney U test, Fisher Exact, Chi-Squared, Kolmogorv-Smirnow||||||0.919|||||||Wilcoxon (Mann-Whitney)|||"sub-population 1 vs. sub-population 2: Parametric and nonparametric univariate tests: t-test for independent samples, Mann-Whitney-U test, Fisher's exact test, chi-square homogeneity test; normal distribution check by Kolmogorov-Smirnov test with Lilliefors -significance correction, type I error = 10%).~Estimate the true effect size:~Two-sided 95% confidence intervals (depending on the nature of the data sets: parametric, non-parametric or Clopper-Pearson) are calculated for all parameters."||||0.919
71073848|NCT04250298|141656428|OTHER|||||||0.033|||||||t-test, 2 sided|||||||0.033
71073849|NCT04250298|141656429|OTHER|||||||0.585|||||||t-test, 2 sided|||||||0.585
71073850|NCT04250298|141656430|OTHER|||||||0.676|||||||t-test, 2 sided|||||||0.676
71073851|NCT04250298|141656431|OTHER|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||||||0.314
71073852|NCT04250298|141656436|OTHER|||||||0.031|||||||t-test, 2 sided|||||||0.031
71073853|NCT04250298|141656437|OTHER|||||||0.862|||||||t-test, 2 sided|||||||0.862
71073854|NCT04250298|141656438|OTHER|||||||0.25|||||||Fisher Exact|||||||0.250
71073855|NCT04250298|141656439|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71073856|NCT04250298|141656440|OTHER|||||||0.001|||||||Fisher Exact|||||||0.001
71073857|NCT04250298|141656441|OTHER|||||||0.055|||||||Wilcoxon (Mann-Whitney)|||||||0.055
71073858|NCT04250298|141656442|OTHER|||||||0.111|||||||Wilcoxon (Mann-Whitney)|||||||0.111
71073859|NCT04250298|141656443|OTHER|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||0.100
71073860|NCT04250298|141656446|OTHER|||||||0.111|||||||Wilcoxon (Mann-Whitney)|||||||0.111
71073861|NCT04250298|141656447|OTHER|||||||0.213|||||||Wilcoxon (Mann-Whitney)|||||||0.213
71073862|NCT05072106|141656505|OTHER|Bioequivalence|Least-squares geometric mean ratio|96.83|||||TWO_SIDED|90.0|81.09|115.62|||||The reported results are the same as the ones reported in the CSR of the trial.|||115.62|81.09|
71073863|NCT05072106|141656506|OTHER|Bioequivalence|Least-squares geometric mean ratio|79.81|||||TWO_SIDED|90.0|64.78|98.32||||||||98.32|64.78|
71073864|NCT05072106|141656507|OTHER|Bioequivalence|Least-squares geometric mean ratio|79.2|||||TWO_SIDED|90.0|64.12|97.82||||||||97.82|64.12|
71073865|NCT05072106|141656508|OTHER|Bioequivalence|Least-squares geometric mean ratio|125.3|||||TWO_SIDED|90.0|101.71|154.36||||||||154.36|101.71|
71073866|NCT05072106|141656509|OTHER|Bioequivalence|Least-squares geometric mean ratio|106.79|||||TWO_SIDED|90.0|74.63|152.8||||||||152.8|74.63|
71073867|NCT05072106|141656510|OTHER|Bioequivalence|Least-squares geometric mean ratio|104.93|||||TWO_SIDED|90.0|69.49|158.44||||||||158.44|69.49|
71073868|NCT05072106|141656511|OTHER|bioequivalence|Least-squares geometric mean ratio|88.44|||||TWO_SIDED|90.0|65.62|119.19||||||||119.19|65.62|
71073869|NCT05072106|141656512|OTHER|bioequivalence|Least-squares geometric mean ratio|81.8|||||TWO_SIDED|90.0|54.8|119.96||||||||119.96|54.8|
71073870|NCT05072106|141656513|OTHER|bioequivalence|Least-squares geometric mean ratio|80.26|||||TWO_SIDED|90.0|54.26|118.72||||||||118.72|54.26|
71073871|NCT05072106|141656514|OTHER|bioequivalence|Least-squares geometric mean ratio|123.34|||||TWO_SIDED|90.0|83.36|182.49||||||||182.49|83.36|
71073872|NCT05072106|141656515|OTHER|bioequivalence|Least-squares geometric mean ratio|120.5|||||TWO_SIDED|90.0|64.79|224.13||||||||224.13|64.79|
71073873|NCT05072106|141656516|OTHER|bioequivalence|Least-squares geometric mean ratio|120.5|||||TWO_SIDED|90.0|64.79|224.13||||||||224.13|64.79|
71073874|NCT05072106|141656517|OTHER|bioequivalence|Least-squares geometric mean ratio|188.13|||||TWO_SIDED|90.0|132.93|266.26||||||PK parameter used was the log-transformed metabolite/parent ratio (MPR) of M1 dose-normalized Cmax.||266.26|132.93|
71073875|NCT05072106|141656518|OTHER|bioequivalence|Least-squares geometric mean ratio|245.46|||||TWO_SIDED|90.0|133.4|451.65||||||PK parameter used was the log-transformed metabolite/parent ratio (MPR) of M1 dose-normalized AUC0-t.||451.65|133.4|
71073876|NCT05072106|141656519|OTHER|bioequivalence|Least-squares geometric mean ratio|104.94|||||TWO_SIDED|90.0|94.07|117.05||||||PK parameter used was the log-transformed metabolite/parent ratio (MPR) of M4 dose-normalized Cmax.||117.05|94.07|
71073877|NCT05072106|141656520|OTHER|bioequivalence|Least-squares geometric mean ratio|91.02|||||TWO_SIDED|90.0|71.39|116.04||||||PK parameter used was the log-transformed metabolite/parent ratio (MPR) of M4 dose-normalized AUC0-t.||116.04|71.39|
71078808|NCT01796301|141665652|SUPERIORITY||Treatment difference|3.6|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.9|4.2|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||4.2|2.9|< 0.0001
71078809|NCT01796301|141665653|SUPERIORITY||Treatment difference|3.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.4|3.8|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||3.8|2.4|< 0.0001
71078810|NCT01796301|141665654|SUPERIORITY||Treatment difference|3.2|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|2.1|4.3|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||4.3|2.1|< 0.0001
71078811|NCT01796301|141665655|SUPERIORITY||Treatment difference|3.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.6|3.6|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||3.6|2.6|< 0.0001
71115651|NCT04115748|141737879|SUPERIORITY||Difference in response rates|12.8||||0.34|TWO_SIDED|95.0|-18.4|44.0||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||44.0|-18.4|0.34
71115652|NCT04115748|141737879|SUPERIORITY||Difference in response rates|32.4||||0.04|TWO_SIDED|95.0|-0.1|64.9||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||64.9|-0.1|0.040
71115653|NCT04115748|141737880|SUPERIORITY||Difference in response rates|5.3|||||TWO_SIDED|95.0|-10.0|20.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||20.6|-10.0|
71115654|NCT04115748|141737880|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-5.4|5.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||5.4|-5.4|
71073878|NCT00869557|141656535|NON_INFERIORITY_OR_EQUIVALENCE|"A total sample size of 75 participants randomized in a 2:1 ratio had 26% power to evaluate noninferiority with respect to the response rate of HIV-1 RNA \< 50 copies/mL at Week 24 if a response rate of 84% for both treatment groups and a noninferiority margin of 0.12 were assumed.~A total of 71 participants were enrolled in the study (4 fewer than planned)."|Difference in the response rates (%)|2.8|||||TWO_SIDED|95.0|-14.5|20.1|||||The 95% confidence interval was computed using normal approximation stratified by baseline HIV-1 RNA stratum (≤ 100,000 or \> 100,000 copies/mL).|The null hypothesis was that the response rate (proportion of participants with HIV-1 RNA \< 50 copies/mL at Week 24) in the Stribild group was at least 12% worse than the response rate in Atripla group; the alternative hypothesis was that the response rate in the Stribild group was less than 12% worse than that in the Atripla group.||20.1|-14.5|
71073879|NCT02304380|141656550|OTHER||Difference in differences|-0.0064|||||TWO_SIDED|95.0|-0.0469|0.034|||||Linear model difference in incidences.|||0.0340|-0.0469|
71073880|NCT02304380|141656551|OTHER||Difference in Differences|0.0506|||||TWO_SIDED|95.0|0.029|0.0722|||||Linear model difference in incidences.|||0.0722|0.0290|
71073881|NCT02304380|141656552|OTHER||Difference in Differences|-0.0005|||||TWO_SIDED|95.0|-0.0109|0.0099|||||Linear model difference in incidences.|||0.0099|-0.0109|
71073882|NCT02304380|141656553|OTHER||Difference in differences|-0.0207|||||TWO_SIDED|95.0|-0.0318|0.0096||||||||0.0096|-0.0318|
71073883|NCT02304380|141656554|OTHER||Difference in differences|0.0163|||||TWO_SIDED|95.0|0.0036|0.0289|||||Linear model difference in incidences.|||0.0289|0.0036|
71073884|NCT02304380|141656555|OTHER||Difference in differences|0.0046|||||TWO_SIDED|95.0|-0.002|0.0111|||||||Linear model difference in incidences.|0.0111|-0.0020|
71115655|NCT04115748|141737880|SUPERIORITY||Difference in response rates|5.3|||||TWO_SIDED|95.0|-9.9|20.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||20.4|-9.9|
71115656|NCT04115748|141737880|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-5.3|5.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||5.3|-5.3|
71115657|NCT04115748|141737880|SUPERIORITY||Difference in response rates|10.5|||||TWO_SIDED|95.0|-14.0|35.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||35.0|-14.0|
71115658|NCT04115748|141737880|SUPERIORITY||Difference in response rates|5.3|||||TWO_SIDED|95.0|-17.1|27.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||27.6|-17.1|
71115659|NCT04115748|141737880|SUPERIORITY||Difference in response rates|27.8|||||TWO_SIDED|95.0|1.7|53.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||53.9|1.7|
70853481|NCT01375075|141195096|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.33||0.988|TWO_SIDED|90.0|-0.53|0.54|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.54|-0.53|0.988
71073885|NCT02304380|141656556|OTHER||Difference in differences|0.0151|||||TWO_SIDED|95.0|-0.0129|0.0431|||||Linear model difference in incidences.|||0.0431|-0.0129|
71073886|NCT02304380|141656557|OTHER||Difference in Differences|-0.0066|||||TWO_SIDED|95.0|-0.0328|0.0197|||||Linear model difference in incidences.|||0.0197|-0.0328|
71073887|NCT02304380|141656558|OTHER||Difference in Differences|-0.0105|||||TWO_SIDED|95.0|-0.0374|0.0163|||||Linear model difference in incidences.|||0.0163|-0.0374|
71073888|NCT02304380|141656559|OTHER||Difference in Differences|0.0006|||||TWO_SIDED|95.0|-0.0031|0.0044|||||Linear model difference in incidences.|||0.0044|-0.0031|
71073889|NCT02304380|141656560|OTHER||Difference in Differences|-0.0293|||||TWO_SIDED|95.0|-0.1025|0.044||||Linear model difference in incidences.||||0.0440|-0.1025|
71073890|NCT02304380|141656561|OTHER||Difference in Differences|-0.0579|||||TWO_SIDED|95.0|-0.1492|0.0116|||||Linear model difference in incidences.|||0.0116|-0.1492|
71115660|NCT04115748|141737880|SUPERIORITY||Difference in response rates|26.3|||||TWO_SIDED|95.0|1.3|51.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||51.4|1.3|
71115661|NCT04115748|141737880|SUPERIORITY||Difference in response rates|12.2|||||TWO_SIDED|95.0|-16.3|40.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||40.8|-16.3|
71115662|NCT04115748|141737880|SUPERIORITY||Difference in response rates|21.6|||||TWO_SIDED|95.0|-8.2|51.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||51.4|-8.2|
71115663|NCT04115748|141737888|SUPERIORITY||Difference in response rates|-10.5|||||TWO_SIDED|95.0|-46.3|25.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||25.2|-46.3|
71115664|NCT04115748|141737888|SUPERIORITY||Difference in response rates|-8.8|||||TWO_SIDED|95.0|-45.3|27.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||27.7|-45.3|
71073891|NCT02304380|141656562|OTHER||Difference in differences|0.0072|||||TWO_SIDED|95.0|0.001|0.0134|||||Linear model difference in incidences.|||0.0134|0.0010|
71073892|NCT02304380|141656563|OTHER||Difference in Differences|0.0058|||||TWO_SIDED|95.0|0.0009|0.0107||||||||0.0107|0.0009|
71073893|NCT02304380|141656564|OTHER||Difference in Differences|0.0054|||||TWO_SIDED|95.0|0.0001|0.0106|||||Linear model difference in incidences.|||0.0106|0.0001|
71073894|NCT02304380|141656565|OTHER||Difference in Differences|-0.0039|||||TWO_SIDED|95.0|-0.0096|0.0017|||||Linear model difference in incidences.|||0.0017|-0.0096|
71115665|NCT04115748|141737888|SUPERIORITY||Difference in response rates|11.8|||||TWO_SIDED|95.0|-22.1|45.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||45.8|-22.1|
70853482|NCT01375075|141195096|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.32||0.207|TWO_SIDED|90.0|-0.95|0.13|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.13|-0.95|0.207
71073895|NCT02304380|141656566|OTHER||Difference in Differences|-0.011|||||TWO_SIDED|95.0|-0.0178|-0.0043|||||Linear model difference in incidences.|||-0.0043|-0.0178|
71073896|NCT02304380|141656567|OTHER||Difference in Differences|0.0026|||||TWO_SIDED|95.0|-0.0036|0.0086|||||Linear model difference in incidences.|||0.0086|-0.0036|
71073897|NCT02304380|141656568|OTHER||Difference in differences|0.0197|||||TWO_SIDED|95.0|0.011|0.0284|||||Linear model difference in incidences.|||0.0284|0.0110|
71115666|NCT04115748|141737888|SUPERIORITY||Difference in response rates|19.4|||||TWO_SIDED|95.0|-15.6|54.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||54.5|-15.6|
71073898|NCT04027075|141656569|SUPERIORITY||Odds Ratio (OR)|1.02||||0.962|TWO_SIDED|95.0|0.51|2.02|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||2.02|0.51|.962
71073899|NCT04027075|141656570|SUPERIORITY||Odds Ratio (OR)|0.47||||0.109|TWO_SIDED|95.0|0.19|1.18|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||1.18|0.19|.109
71073900|NCT04027075|141656571|SUPERIORITY||Odds Ratio (OR)|1.58||||0.227|TWO_SIDED|95.0|0.75|3.29|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||3.29|0.75|.227
71073901|NCT04027075|141656572|SUPERIORITY||Odds Ratio (OR)|1.2||||0.681|TWO_SIDED|95.0|0.5|2.87|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||2.87|0.50|.681
71115667|NCT04115748|141737888|SUPERIORITY||Difference in response rates|10.5|||||TWO_SIDED|95.0|-26.0|47.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||47.0|-26.0|
71115668|NCT04115748|141737888|SUPERIORITY||Difference in response rates|10.5|||||TWO_SIDED|95.0|-26.0|47.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||47.0|-26.0|
71115669|NCT04115748|141737888|SUPERIORITY||Difference in response rates|29.8|||||TWO_SIDED|95.0|-6.3|66.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||66.0|-6.3|
71115670|NCT04115748|141737888|SUPERIORITY||Difference in response rates|31.6|||||TWO_SIDED|95.0|-3.8|67.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||67.0|-3.8|
71115671|NCT04115748|141737888|SUPERIORITY||Difference in response rates|5.0|||||TWO_SIDED|95.0|-32.0|42.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||42.0|-32.0|
71115672|NCT04115748|141737888|SUPERIORITY||Difference in response rates|39.2|||||TWO_SIDED|95.0|6.8|71.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||71.6|6.8|
71115673|NCT04115748|141737889|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-24.8|24.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||24.8|-24.8|
71115674|NCT04115748|141737889|SUPERIORITY||Difference in response rates|0.6|||||TWO_SIDED|95.0|-24.9|26.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||26.0|-24.9|
71115675|NCT04115748|141737889|SUPERIORITY||Difference in response rates|-4.5|||||TWO_SIDED|95.0|-30.5|21.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||21.5|-30.5|
71115676|NCT04115748|141737889|SUPERIORITY||Difference in response rates|12.8|||||TWO_SIDED|95.0|-18.4|44.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||44.0|-18.4|
71115677|NCT04115748|141737889|SUPERIORITY||Difference in response rates|21.1|||||TWO_SIDED|95.0|-14.1|56.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||56.3|-14.1|
71115678|NCT04115748|141737889|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-33.3|33.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||33.3|-33.3|
71115679|NCT04115748|141737889|SUPERIORITY||Difference in response rates|34.5|||||TWO_SIDED|95.0|-0.3|69.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||69.3|-0.3|
71115680|NCT04115748|141737889|SUPERIORITY||Difference in response rates|21.1|||||TWO_SIDED|95.0|-13.0|55.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||55.1|-13.0|
70853483|NCT01375075|141195097|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.43||0.756|TWO_SIDED|90.0|-0.57|0.84|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.84|-0.57|0.756
70853484|NCT01375075|141195097|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.43||0.99|TWO_SIDED|90.0|-0.71|0.7|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.70|-0.71|0.990
71115681|NCT04115748|141737889|SUPERIORITY||Difference in response rates|24.4|||||TWO_SIDED|95.0|-9.7|58.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||58.6|-9.7|
71115682|NCT04115748|141737889|SUPERIORITY||Difference in response rates|32.6|||||TWO_SIDED|95.0|-1.0|66.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||66.2|-1.0|
71115683|NCT04115748|141737891|SUPERIORITY||Difference in response rates|-15.8|||||TWO_SIDED|95.0|-47.6|16.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||16.0|-47.6|
71115684|NCT04115748|141737891|SUPERIORITY||Difference in response rates|-20.5|||||TWO_SIDED|95.0|-51.3|10.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||10.4|-51.3|
71115685|NCT04115748|141737891|SUPERIORITY||Difference in response rates|6.6|||||TWO_SIDED|95.0|-26.8|39.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||39.9|-26.8|
71115686|NCT04115748|141737891|SUPERIORITY||Difference in response rates|13.9|||||TWO_SIDED|95.0|-20.8|48.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||48.6|-20.8|
71115687|NCT04115748|141737891|SUPERIORITY||Difference in response rates|15.8|||||TWO_SIDED|95.0|-20.7|52.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||52.3|-20.7|
71115688|NCT04115748|141737891|SUPERIORITY||Difference in response rates|5.3|||||TWO_SIDED|95.0|-31.0|41.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||41.6|-31.0|
71115689|NCT04115748|141737891|SUPERIORITY||Difference in response rates|24.3|||||TWO_SIDED|95.0|-12.4|60.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||60.9|-12.4|
71115690|NCT04115748|141737891|SUPERIORITY||Difference in response rates|21.1|||||TWO_SIDED|95.0|-15.2|57.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||57.4|-15.2|
71073902|NCT04027075|141656573|SUPERIORITY||Odds Ratio (OR)|1.18||||0.65|TWO_SIDED|95.0|0.58|2.42|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||2.42|0.58|.650
71073903|NCT04027075|141656574|SUPERIORITY||Odds Ratio (OR)|1.41||||0.304|TWO_SIDED|95.0|0.73|2.73|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||2.73|0.73|.304
71073904|NCT04027075|141656575|SUPERIORITY||Odds Ratio (OR)|1.44||||0.97|TWO_SIDED|95.0|0.69|3.0|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||3.00|0.69|0.97
71115691|NCT04115748|141737891|SUPERIORITY||Difference in response rates|4.4|||||TWO_SIDED|95.0|-32.3|41.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||41.2|-32.3|
71115692|NCT04115748|141737891|SUPERIORITY||Difference in response rates|23.2|||||TWO_SIDED|95.0|-12.5|58.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||58.8|-12.5|
71115693|NCT04115748|141737892|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-19.5|19.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||19.5|-19.5|
71115694|NCT04115748|141737892|SUPERIORITY||Difference in response rates|-5.3|||||TWO_SIDED|95.0|-20.7|10.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||10.2|-20.7|
71073905|NCT04027075|141656576|SUPERIORITY||Mean Difference (Final Values)|-1.78|STANDARD_ERROR_OF_MEAN|0.64||0.005|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.005
71073906|NCT04027075|141656577|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|1.09||0.46|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.460
71115695|NCT04115748|141737892|SUPERIORITY||Difference in response rates|0.3|||||TWO_SIDED|95.0|-18.7|19.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||19.3|-18.7|
71073907|NCT04027075|141656578|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.26||0.851|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.851
70853485|NCT01375075|141195097|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.44||0.565|TWO_SIDED|90.0|-0.47|0.97|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.97|-0.47|0.565
71073908|NCT04027075|141656579|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.23||0.977|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.977
71115696|NCT04115748|141737892|SUPERIORITY||Difference in response rates|0.6|||||TWO_SIDED|95.0|-19.0|20.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||20.1|-19.0|
71115697|NCT04115748|141737892|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-24.8|24.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||24.8|-24.8|
71115698|NCT04115748|141737892|SUPERIORITY||Difference in response rates|-5.3|||||TWO_SIDED|95.0|-27.6|17.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||17.1|-27.6|
71115699|NCT04115748|141737892|SUPERIORITY||Difference in response rates|17.0|||||TWO_SIDED|95.0|-10.1|44.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||44.0|-10.1|
71115700|NCT04115748|141737892|SUPERIORITY||Difference in response rates|26.3|||||TWO_SIDED|95.0|-2.1|54.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||54.8|-2.1|
71115701|NCT04115748|141737892|SUPERIORITY||Difference in response rates|6.7|||||TWO_SIDED|95.0|-20.3|33.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||33.6|-20.3|
71115702|NCT04115748|141737892|SUPERIORITY||Difference in response rates|11.1|||||TWO_SIDED|95.0|-16.6|38.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||38.7|-16.6|
71115703|NCT04115748|141737894|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-34.8|34.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||34.8|-34.8|
71073909|NCT04027075|141656580|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.27||0.456|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.456
71073910|NCT04027075|141656581|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.31||0.874|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.874
71073911|NCT04027075|141656582|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.24||0.069|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.069
71073912|NCT04027075|141656583|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.658|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.658
71073913|NCT04027075|141656584|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.783|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.783
71073914|NCT00956631|141656591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2|||<|0.0001|TWO_SIDED|95.0|2.29|4.13|||t-test, 2 sided|||The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used throughout. A hypothetical average improvement of zero was used.||4.13|2.29|<0.0001
71073915|NCT00956631|141656592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.58|||<|0.0001|TWO_SIDED|95.0|12.33|22.83|||t-test, 2 sided|||The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used. A hypothetical average improvement of zero was used.||22.83|12.33|<0.0001
71073916|NCT00455520|141656618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.001||95.0|-1.7|-0.92|||ANCOVA|||Analysis of Covariance Model with factors of treatment, country, prior opioid use, and baseline dose level and start of DB pain score as factors.||-0.92|-1.7|<0.001
71073917|NCT02248974|141656632|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||The model uses a general linear mixed model with fixed effects for baseline Knowledge Scale score, time (discrete), arm, and a time-arm interaction term. The matrix of correlated residual terms assumes an unstructured format.||||0.01
71073918|NCT02248974|141656633|SUPERIORITY|||||||0.47|||||||Mixed Models Analysis|||The model uses a general linear mixed model with fixed effects for baseline KS score, time (discrete), arm, and a time-arm interaction term. The matrix of correlated residual terms assumes an unstructured format.||||0.47
71073919|NCT02248974|141656634|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Used Wilcoxon 2-sample test to see if DA group had significantly better (i.e. lower) Decisional Conflict Scores than no-DA (Control) group.||||0.12
71073920|NCT02248974|141656635|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||Used Wilcoxon 2-sample test to see if DA group had significantly better (i.e. lower) Decisional Conflict Scores than no-DA (Control) group.||||0.79
71073921|NCT02248974|141656636|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||||||0.99
71073922|NCT02248974|141656637|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||||||0.94
71073923|NCT02248974|141656638|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
71073924|NCT02248974|141656639|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
71073925|NCT02248974|141656640|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
71073926|NCT02248974|141656641|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||||||0.006
71073927|NCT02248974|141656642|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
71073928|NCT02248974|141656644|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
71073929|NCT02248974|141656645|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
71073930|NCT02248974|141656649|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.60
71073931|NCT02248974|141656650|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
71073932|NCT02248974|141656651|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||||||0.45
71073933|NCT02248974|141656652|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||||||0.006
71073934|NCT02248974|141656653|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
71073935|NCT02248974|141656654|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
71073936|NCT02248974|141656656|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
71073937|NCT02248974|141656657|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
71073938|NCT02248974|141656658|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
71073939|NCT02248974|141656665|SUPERIORITY|||||||0.98|||||||Fisher Exact|||||||0.98
71073940|NCT02248974|141656666|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.20
71073941|NCT00628095|141656676|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-0.0221||||0.591|TWO_SIDED|90.0|-0.17|0.13|||Normal Approximation method|No adjustments for multiple comparisons were performed.|Power of 80% and a Type I error at 0.10 in a 1-sided test was calculated. Null hypothesis stated that there was no difference between the CE-224,535 and placebo arm groups, on the percentage of ACR 20 responders at Week 12.|Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the normal approximation method.||0.13|-0.17|0.591
71073942|NCT00628095|141656677|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-0.1232||||0.941|TWO_SIDED|80.0|-0.22|-0.02|||Normal Approximation method|||Week 2: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the normal approximation method.||-0.02|-0.22|0.941
71073943|NCT00628095|141656677|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-0.0622||||0.742|TWO_SIDED|80.0|-0.18|0.05|||Normal Approximation method|||Week 4: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the normal approximation method.||0.05|-0.18|0.742
71073944|NCT00628095|141656677|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|0.004||||0.482|TWO_SIDED|80.0|-0.11|0.12|||Normal Approximation method|||Week 8: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the normal approximation method.||0.12|-0.11|0.482
71073945|NCT00628095|141656678|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-0.0072||||0.989|TWO_SIDED|80.0|-0.08|0.06|||Barnard exact test|||Week 2: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the Barnard exact test.||0.06|-0.08|0.989
71073946|NCT00628095|141656678|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-0.0096||||0.957|TWO_SIDED|80.0|-0.08|0.07|||Barnard exact test|||Week 4: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the Barnard exact test.||0.07|-0.08|0.957
71073947|NCT00628095|141656678|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|0.0044||||0.473|TWO_SIDED|80.0|-0.08|0.09|||Normal Approximation method|||Week 8: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the normal approximation method.||0.09|-0.08|0.473
71073948|NCT00628095|141656678|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-0.057||||0.793|TWO_SIDED|80.0|-0.15|0.03|||Normal Approximation method|||Week 12: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the normal approximation method.||0.03|-0.15|0.793
71073949|NCT00628095|141656679|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|0.0377||||0.121|TWO_SIDED|80.0|0.0|0.09|||Barnard exact test|||Week 2: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the Barnard exact test.||0.09|-0.00|0.121
71073950|NCT00628095|141656679|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|0.0141||||0.421|TWO_SIDED|80.0|-0.05|0.07|||Barnard exact test|||Week 4: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the Barnard exact test.||0.07|-0.05|0.421
71073951|NCT00628095|141656679|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|0.0566||||0.058|TWO_SIDED|80.0|0.01|0.12|||Barnard exact test|||Week 8: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the Barnard exact test.||0.12|0.01|0.058
71073952|NCT00628095|141656679|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|0.0377||||0.121|TWO_SIDED|80.0|0.0|0.09|||Barnard exact test|||Week 12: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the Barnard exact test.||0.09|-0.00|0.121
71073953|NCT00628095|141656687|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Barnard exact test|||Week 2: p-value was analyzed using Barnard Exact Test.||||1.0000
71073954|NCT00628095|141656687|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Barnard exact test|||Week 4: p-value was analyzed using Barnard Exact Test.||||1.0000
71073955|NCT00628095|141656687|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Barnard exact test|||Week 8: p-value was analyzed using Barnard Exact Test.||||1.0000
71073956|NCT00628095|141656687|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0637|TWO_SIDED||||||Barnard exact test|||Week 12: p-value was analyzed using Barnard Exact Test.||||0.0637
71073957|NCT00628095|141656687|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0637|TWO_SIDED||||||Barnard exact test|||Week 14: p-value was analyzed using Barnard Exact Test.||||0.0637
71073958|NCT01928797|141656700|SUPERIORITY|||||||0.37|||||||Chi-squared|||||||0.37
71073959|NCT01928797|141656701|SUPERIORITY|||||||0.33|||||||Chi-squared|||||||0.33
71073960|NCT00006305|141656703|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.005||||0.97|TWO_SIDED|95.0|-0.031|0.02||A separate test with alpha=0.05 was conducted for each treatment comparison of the main effects in the 2x2 factorial design.|Log Rank||Risk difference of all-cause mortality for Revascularization compared with Medical therapy|||0.020|-0.031|0.97
71115704|NCT04115748|141737894|SUPERIORITY||Difference in response rates|-14.9|||||TWO_SIDED|95.0|-47.4|17.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||17.6|-47.4|
71115705|NCT04115748|141737894|SUPERIORITY||Difference in response rates|27.9|||||TWO_SIDED|95.0|-7.2|63.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||63.0|-7.2|
71115706|NCT04115748|141737894|SUPERIORITY||Difference in response rates|8.9|||||TWO_SIDED|95.0|-26.6|44.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||44.3|-26.6|
71115707|NCT04115748|141737894|SUPERIORITY||Difference in response rates|21.1|||||TWO_SIDED|95.0|-13.0|55.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||55.1|-13.0|
71115708|NCT04115748|141737894|SUPERIORITY||Difference in response rates|-10.5|||||TWO_SIDED|95.0|-47.4|26.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||26.3|-47.4|
71115709|NCT04115748|141737894|SUPERIORITY||Difference in response rates|24.9|||||TWO_SIDED|95.0|-11.1|60.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||60.8|-11.1|
71115710|NCT04115748|141737894|SUPERIORITY||Difference in response rates|21.1|||||TWO_SIDED|95.0|-14.9|57.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||57.0|-14.9|
71073961|NCT00006305|141656703|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.003||||0.89|TWO_SIDED|95.0|-0.029|0.022||A separate test with alpha=0.05 was conducted for each treatment comparison of the main effects in the 2x2 factorial design.|Log Rank||Risk difference of all-cause mortality for Insulin Sensitizing glycemic control strategy compared with Insulin Providing glycemic control strategy|||0.022|-0.029|0.89
71073962|NCT00006305|141656704|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.013||||0.7|TWO_SIDED|95.0|-0.049|0.022||A separate test with alpha=0.05 was conducted for each treatment comparison of the main effects in the 2x2 factorial design.|Log Rank||Risk difference of Death/MI/Stroke for Revascularization compared with Medical Therapy|||0.022|-0.049|0.70
71073963|NCT00006305|141656704|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.024||||0.13||95.0|-0.06|0.012||A separate test with alpha=0.05 was conducted for each treatment comparison of the main effects in the 2x2 factorial design.|Log Rank||Risk difference of Death/MI/Stroke for Insulin Sensitizing glycemic control strategy compared with Insulin Providing glycemic control strategy|||0.012|-0.060|0.13
71073964|NCT00662558|141656705|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Differences in treatment proportions and the 95% confidence interval (CI) around the difference were estimated by calculating the risk difference between the treatment arms using a generalized linear model with treatment and center as factors. A lower 95% CI for the risk difference greater than -0.10 would demonstrate that celecoxib 200 mg BID is not inferior to tramadol hydrochloride 50 mg QID.|Risk Difference (RD)|0.091||||||95.0|0.0255|0.1565||||||||0.1565|0.0255|
71073965|NCT00662558|141656705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0|||||Cochran-Mantel-Haenszel|||If celecoxib 200 mg BID was found to be non-inferior to tramadol hydrochloride 50 mg QID then the second step was to test the superiority of celecoxib 200 mg BID over tramadol hydrochloride 50 mg QID using a two-sided test of proportions. Differences in proportions were tested using the General Association Test of the Cochran-Mantel-Haenszel (CMH) procedure stratified by center.||||0.008
71073966|NCT00662558|141656706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.234||95.0|-0.53|0.13|||ANCOVA||The mean difference reported is the least squares (LS) mean difference.|The change from Baseline was compared between the two treatment groups using analysis of covariance (ANCOVA), with treatment and center as factors, and Baseline value as a covariate.||0.13|-0.53|0.234
71073967|NCT00662558|141656707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|1.76||0.595||95.0|-4.39|2.52|||ANCOVA||The mean difference reported is the LS mean difference.|The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||2.52|-4.39|0.595
71073968|NCT00662558|141656708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.829||95.0|||||Cochran-Mantel-Haenszel|||CMH tests using row mean score and adjusted for center was used to compare the two treatment groups.||||0.829
71073969|NCT00662558|141656709|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47||95.0|||||Cochran-Mantel-Haenszel|||CMH tests using row mean score and adjusted for center was used to compare the two treatment groups.||||0.470
71073970|NCT00662558|141656710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.32||0.339||95.0|-0.95|0.33|||ANCOVA||The mean difference reported is the LS mean difference.|The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.33|-0.95|0.339
71073971|NCT00662558|141656711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.16||0.741||95.0|-0.36|0.25|||ANCOVA||The mean difference reported is the LS mean difference.|How Much Pain Now. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.25|-0.36|0.741
71073972|NCT00662558|141656711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.17||0.796||95.0|-0.38|0.29|||ANCOVA||The mean difference reported is the LS mean difference.|Worst Pain in Past 24 Hours. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.29|-0.38|0.796
71115711|NCT04115748|141737894|SUPERIORITY||Difference in response rates|43.9|||||TWO_SIDED|95.0|12.4|75.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||75.4|12.4|
71115712|NCT04115748|141737894|SUPERIORITY||Difference in response rates|12.9|||||TWO_SIDED|95.0|-23.4|49.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||49.1|-23.4|
71115713|NCT04115748|141737896|SUPERIORITY||Difference in response rates|37.5|||||TWO_SIDED|95.0|-14.8|89.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||89.8|-14.8|
71115714|NCT04115748|141737896|SUPERIORITY||Difference in response rates|40.0|||||TWO_SIDED|95.0|-25.4|100.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||100.0|-25.4|
70853486|NCT01375075|141195097|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.43||0.678|TWO_SIDED|90.0|-0.53|0.89|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.89|-0.53|0.678
71073973|NCT00662558|141656711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.16||0.492||95.0|-0.41|0.2|||ANCOVA||The mean difference reported is the LS mean difference.|Average Pain in Past 24 Hours. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.20|-0.41|0.492
71073974|NCT00662558|141656711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.16||0.893||95.0|-0.28|0.33|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With General Activity. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.33|-0.28|0.893
71073975|NCT00662558|141656711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.16||0.618||95.0|-0.4|0.24|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Mood. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.24|-0.40|0.618
71073976|NCT00662558|141656711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.16||0.44||95.0|-0.19|0.43|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Walking Activity. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.43|-0.19|0.440
71073977|NCT00662558|141656711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.14||0.806||95.0|-0.25|0.32|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Relations With Others. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.32|-0.25|0.806
71115715|NCT04115748|141737896|SUPERIORITY||Difference in response rates|-25.0|||||TWO_SIDED|95.0|-100.0|51.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||51.2|-100.0|
71115716|NCT04115748|141737896|SUPERIORITY||Difference in response rates|-10.0|||||TWO_SIDED|95.0|-97.7|77.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||77.7|-97.7|
70853487|NCT01375075|141195098|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.61||0.856|TWO_SIDED|90.0|-0.9|1.12|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.12|-0.90|0.856
71115717|NCT04115748|141737896|SUPERIORITY||Difference in response rates|7.1|||||TWO_SIDED|95.0|-73.7|88.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||88.0|-73.7|
71115718|NCT04115748|141737896|SUPERIORITY||Difference in response rates|-10.0|||||TWO_SIDED|95.0|-97.7|77.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||77.7|-97.7|
71115719|NCT04115748|141737896|SUPERIORITY||Difference in response rates|37.5|||||TWO_SIDED|95.0|-35.3|100.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||100.0|-35.3|
71115720|NCT04115748|141737896|SUPERIORITY||Difference in response rates|15.0|||||TWO_SIDED|95.0|-67.9|97.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||97.9|-67.9|
71073978|NCT00662558|141656711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.17||0.739||95.0|-0.38|0.27|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Sleep. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.27|-0.38|0.739
71073979|NCT00662558|141656711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.992||95.0|-0.32|0.33|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Normal Work. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.33|-0.32|0.992
71073980|NCT00662558|141656711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.16||0.793||95.0|-0.28|0.36|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Enjoyment of Life. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.36|-0.28|0.793
71073981|NCT00662558|141656711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.973||95.0|-0.27|0.28|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interference Subscale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.28|-0.27|0.973
71073982|NCT00662558|141656712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|1.51||0.392||95.0|-4.26|1.67|||ANCOVA||The mean difference reported is the LS mean difference.|Sleep Disturbance. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.67|-4.26|0.392
71073983|NCT00662558|141656712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|1.67||0.691||95.0|-3.94|2.61|||ANCOVA||The mean difference reported is the LS mean difference.|Snoring. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||2.61|-3.94|0.691
71073984|NCT00662558|141656712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|1.45||0.549||95.0|-3.7|1.97|||ANCOVA||The mean difference reported is the LS mean difference.|Awaken Shortness of Breath or Headache. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.97|-3.70|0.549
71073985|NCT00662558|141656712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.23||0.336||95.0|-0.67|0.23|||ANCOVA||The mean difference reported is the LS mean difference.|Quantity of Sleep. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.23|-0.67|0.336
71073986|NCT00662558|141656712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|1.69||0.37||95.0|-4.83|1.8|||ANCOVA||The mean difference reported is the LS mean difference.|Sleep Adequacy. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.80|-4.83|0.370
71073987|NCT00662558|141656712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.27|STANDARD_ERROR_OF_MEAN|1.34||0.341||95.0|-3.9|1.35|||ANCOVA||The mean difference reported is the LS mean difference.|Somnolence. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.35|-3.90|0.341
71073988|NCT00662558|141656712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|1.15||0.604||95.0|-2.85|1.66|||ANCOVA||The mean difference reported is the LS mean difference.|Sleep Problem Index I. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.66|-2.85|0.604
71073989|NCT00662558|141656712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|1.14||0.547||95.0|-2.92|1.55|||ANCOVA||The mean difference reported is the LS mean difference.|Sleep Problem Index II. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.55|-2.92|0.547
71073990|NCT00662558|141656713|SUPERIORITY_OR_OTHER_LEGACY|||||||0.196||95.0|||||Cochran-Mantel-Haenszel|||Optimal sleep was analyzed using CMH general association test.||||0.196
71073991|NCT00662558|141656714|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.19|STANDARD_ERROR_OF_MEAN|1.91||0.252||95.0|-1.56|5.94|||ANCOVA||The mean difference reported is the LS mean difference.|Time Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||5.94|-1.56|0.252
71073992|NCT00662558|141656714|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|1.88||0.798||95.0|-3.21|4.17|||ANCOVA||The mean difference reported is the LS mean difference.|Physical Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||4.17|-3.21|0.798
71115721|NCT04115748|141737897|SUPERIORITY||Difference in response rates|12.5|||||TWO_SIDED|95.0|-29.2|54.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||54.2|-29.2|
71115722|NCT04115748|141737897|SUPERIORITY||Difference in response rates|20.0|||||TWO_SIDED|95.0|-37.6|77.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||77.6|-37.6|
71115723|NCT04115748|141737897|SUPERIORITY||Difference in response rates|25.0|||||TWO_SIDED|95.0|-23.8|73.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||73.8|-23.8|
71115724|NCT04115748|141737897|SUPERIORITY||Difference in response rates|40.0|||||TWO_SIDED|95.0|-25.4|100.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||100.0|-25.4|
71115725|NCT04115748|141737897|SUPERIORITY||Difference in response rates|42.9|||||TWO_SIDED|95.0|-13.4|99.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||99.2|-13.4|
71115726|NCT04115748|141737897|SUPERIORITY||Difference in response rates|40.0|||||TWO_SIDED|95.0|-25.4|100.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||100.0|-25.4|
71115727|NCT04115748|141737897|SUPERIORITY||Difference in response rates|37.5|||||TWO_SIDED|95.0|-35.3|100.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||100.0|-35.3|
71115728|NCT04115748|141737897|SUPERIORITY||Difference in response rates|-5.0|||||TWO_SIDED|95.0|-82.5|72.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||72.5|-82.5|
70853488|NCT01375075|141195098|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.61||0.869|TWO_SIDED|90.0|-0.9|1.1|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.10|-0.90|0.869
71115729|NCT04115748|141737898|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-18.8|18.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||18.8|-18.8|
71115730|NCT04115748|141737898|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-22.5|22.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||22.5|-22.5|
71115731|NCT04115748|141737898|SUPERIORITY||Difference in response rates|12.5|||||TWO_SIDED|95.0|-29.2|54.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||54.2|-29.2|
71115732|NCT04115748|141737898|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-22.5|22.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||22.5|-22.5|
71115733|NCT04115748|141737898|SUPERIORITY||Difference in response rates|14.3|||||TWO_SIDED|95.0|-31.3|59.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||59.9|-31.3|
71115734|NCT04115748|141737898|SUPERIORITY||Difference in response rates|20.0|||||TWO_SIDED|95.0|-37.6|77.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||77.6|-37.6|
71115735|NCT04115748|141737898|SUPERIORITY||Difference in response rates|25.0|||||TWO_SIDED|95.0|-23.8|73.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||73.8|-23.8|
71115736|NCT04115748|141737898|SUPERIORITY||Difference in response rates|20.0|||||TWO_SIDED|95.0|-37.6|77.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||77.6|-37.6|
71115737|NCT04115748|141737899|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-18.8|18.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||18.8|-18.8|
71115738|NCT04115748|141737899|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-22.5|22.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||22.5|-22.5|
71115739|NCT04115748|141737899|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-18.8|18.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||18.8|-18.8|
71115740|NCT04115748|141737899|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-22.5|22.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||22.5|-22.5|
71115741|NCT04115748|141737899|SUPERIORITY||Difference in response rates|14.3|||||TWO_SIDED|95.0|-31.3|59.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||59.9|-31.3|
71115742|NCT04115748|141737899|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-22.5|22.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||22.5|-22.5|
71115743|NCT04115748|141737899|SUPERIORITY||Difference in response rates|12.5|||||TWO_SIDED|95.0|-29.2|54.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||54.2|-29.2|
71115744|NCT04115748|141737899|SUPERIORITY||Difference in response rates|20.0|||||TWO_SIDED|95.0|-37.6|77.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||77.6|-37.6|
71115745|NCT04115748|141737903|SUPERIORITY||LS Mean Treatment Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.104||0.94|TWO_SIDED|95.0|-0.22|0.2||P-value was calculated from mixed-effects model for repeated measures (MMRM) including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 2||0.20|-0.22|0.94
71115746|NCT04115748|141737903|SUPERIORITY||LS Mean Treatment Difference|0.03|STANDARD_ERROR_OF_MEAN|0.105||0.81|TWO_SIDED|95.0|-0.18|0.24||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 2||0.24|-0.18|0.81
71115747|NCT04115748|141737903|SUPERIORITY||LS Mean Treatment Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.112||0.13|TWO_SIDED|95.0|-0.39|0.05||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 4||0.05|-0.39|0.13
71115748|NCT04115748|141737903|SUPERIORITY||LS Mean Treatment Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.113||0.073|TWO_SIDED|95.0|-0.43|0.02||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 4||0.02|-0.43|0.073
71115749|NCT04115748|141737903|SUPERIORITY||LS Mean Treatment Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.124||0.083|TWO_SIDED|95.0|-0.46|0.03||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 8||0.03|-0.46|0.083
71115750|NCT04115748|141737903|SUPERIORITY||LS Mean Treatment Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.124||0.28|TWO_SIDED|95.0|-0.38|0.11||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 8||0.11|-0.38|0.28
71115751|NCT04115748|141737903|SUPERIORITY||LS Mean Treatment Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.13||0.038|TWO_SIDED|95.0|-0.54|-0.02||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 12||-0.02|-0.54|0.038
70940393|NCT00141271|141380811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.926||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.9260
71115752|NCT04115748|141737903|SUPERIORITY||LS Mean Treatment Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.129||0.25|TWO_SIDED|95.0|-0.41|0.11||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 12||0.11|-0.41|0.25
71115753|NCT04115748|141737903|SUPERIORITY||LS Mean Treatment Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.139||0.41|TWO_SIDED|95.0|-0.39|0.16||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 16||0.16|-0.39|0.41
71115754|NCT04115748|141737903|SUPERIORITY||LS Mean Treatment Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.138||0.26|TWO_SIDED|95.0|-0.43|0.12||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 16||0.12|-0.43|0.26
71115755|NCT04115748|141737904|SUPERIORITY||LS Mean Treatment Difference|3.4|STANDARD_ERROR_OF_MEAN|2.26||0.14|TWO_SIDED|95.0|-1.1|7.9||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 4||7.9|-1.1|0.14
71115756|NCT04115748|141737904|SUPERIORITY||LS Mean Treatment Difference|3.1|STANDARD_ERROR_OF_MEAN|2.3||0.18|TWO_SIDED|95.0|-1.5|7.7||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 4||7.7|-1.5|0.18
71115757|NCT04115748|141737904|SUPERIORITY||LS Mean Treatment Difference|3.7|STANDARD_ERROR_OF_MEAN|2.53||0.15|TWO_SIDED|95.0|-1.4|8.7||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 16||8.7|-1.4|0.15
71115758|NCT04115748|141737904|SUPERIORITY||LS Mean Treatment Difference|4.8|STANDARD_ERROR_OF_MEAN|2.54||0.062|TWO_SIDED|95.0|-0.3|9.9||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 16||9.9|-0.3|0.062
71073993|NCT00662558|141656714|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.74|STANDARD_ERROR_OF_MEAN|1.92||0.7||95.0|-3.03|4.51|||ANCOVA||The mean difference reported is the LS mean difference.|Output Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||4.51|-3.03|0.700
71073994|NCT00662558|141656714|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|1.72||0.902||95.0|-3.16|3.59|||ANCOVA||The mean difference reported is the LS mean difference.|Mental-Interpersonal Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||3.59|-3.16|0.902
71115759|NCT04115748|141737906|SUPERIORITY||LS Mean Treatment Difference|5.3|STANDARD_ERROR_OF_MEAN|1.68||0.003|TWO_SIDED|95.0|1.9|8.6||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 4||8.6|1.9|0.003
71115760|NCT04115748|141737906|SUPERIORITY||LS Mean Treatment Difference|4.9|STANDARD_ERROR_OF_MEAN|1.71||0.006|TWO_SIDED|95.0|1.5|8.3||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 4||8.3|1.5|0.006
71115761|NCT04115748|141737906|SUPERIORITY||LS Mean Treatment Difference|3.8|STANDARD_ERROR_OF_MEAN|2.09||0.076|TWO_SIDED|95.0|-0.4|8.0||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 16||8.0|-0.4|0.076
71115762|NCT04115748|141737906|SUPERIORITY||LS Mean Treatment Difference|3.5|STANDARD_ERROR_OF_MEAN|2.1||0.1|TWO_SIDED|95.0|-0.7|7.7||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 16||7.7|-0.7|0.10
71115763|NCT01200407|141737917|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-35.8||||0|TWO_SIDED|95.0|-37.2|-34.4|||t-test, 2 sided|||SBP with LOCF (Week 12)||-34.4|-37.2|0.000
71115764|NCT01200407|141737917|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-19.4||||0|TWO_SIDED|95.0|-20.3|-18.6|||t-test, 2 sided|||DBP with LOCF (Week 12)||-18.6|-20.3|0.000
71115765|NCT01200407|141737918|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-24.7||||0|TWO_SIDED|95.0|-26.1|-23.4|||t-test, 2 sided|||SBP w/o LOCF (Week 4)||-23.4|-26.1|0.000
70853489|NCT01375075|141195098|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.62||0.869|TWO_SIDED|90.0|-0.92|1.13|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.13|-0.92|0.869
71115766|NCT01200407|141737918|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-33.0||||0|TWO_SIDED|95.0|-34.4|-31.6|||t-test, 2 sided|||SBP w/o LOCF (Week 8)||-31.6|-34.4|0.000
71115767|NCT01200407|141737918|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-36.3||||0|TWO_SIDED|95.0|-37.9|-34.7|||t-test, 2 sided|||SBP w/o LOCF (Week 12)||-34.7|-37.9|0.000
71115768|NCT01200407|141737918|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-13.2||||0|TWO_SIDED|95.0|-14.0|-12.4|||t-test, 2 sided|||DBP w/o LOCF (Week 4)||-12.4|-14.0|0.000
71115769|NCT01200407|141737918|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-17.6||||0|TWO_SIDED|95.0|-18.4|-16.7|||t-test, 2 sided|||DBP w/o LOCF (Week 8)||-16.7|-18.4|0.000
71115770|NCT01200407|141737918|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-19.9||||0|TWO_SIDED|95.0|-20.8|-18.9|||t-test, 2 sided|||DBP w/o LOCF (Week 12)||-18.9|-20.8|0.000
71115771|NCT00473668|141737951|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if upper limit (UL) of the two-sided 95% confidence interval (CI) for the differences between the two groups in terms of anti-PRP seroprotection (SPR) rates was below (\<) 10%.|Difference in anti-PRP SPR rate|-1.18|||||TWO_SIDED|95.0|-6.39|2.84||||||Demonstration of the non-inferiority of Tritanrix™-HepB/Hiberix™ Kft. vaccine compared to Tritanrix™-HepB/Hiberix™ vaccine with respect to the anti-PRP antibody response, after a three-dose primary vaccination course.||2.84|-6.39|
71115772|NCT00473668|141737951|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if upper limit (UL) of the two-sided 95% confidence interval (CI) for the differences between the two groups in terms of anti-PRP seroprotection (SPR) rates was below (\<) 10%.|Difference in anti-PRP SPR rate|0.0|||||TWO_SIDED|95.0|-4.16|3.99||||||Demonstration of the non-inferiority of Tritanrix™-HepB/Hiberix™ Kft. vaccine compared to Tritanrix™-HepB/Hiberix™ vaccine with respect to the anti-PRP antibody response, after a three-dose primary vaccination course.||3.99|-4.16|
71115773|NCT03458910|141737977|SUPERIORITY|||||||0.782|||||||ANOVA|||A 2 (time: pre, post) X 2 (condition: HRV-increase, HRV-decrease) ANOVA was performed.||||0.782
71115774|NCT03458910|141737978|SUPERIORITY|||||||0.48|||||||ANOVA|||A 2 (time: pre, post) X 2 (condition: HRV-increase, HRV-decrease) ANOVA was performed.||||0.480
71115775|NCT03458910|141737979|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||An independent t-test was performed to compare the two groups.||||0.410
71115776|NCT03458910|141737980|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||An independent t-test was performed to compare the two groups.||||0.480
71115777|NCT03458910|141737981|SUPERIORITY|||||||0.17|||||||ANOVA|||time x condition x regulation goal interaction in behavioral emotional intensity rating for younger adults||||0.170
71115778|NCT03458910|141737982|SUPERIORITY|||||||0.478|||||||ANOVA|||time x condition x regulation goal interaction in behavioral emotional intensity rating for older adults||||0.478
71115779|NCT03458910|141737983|SUPERIORITY|||||||0.441|||||||ANOVA|||time x condition x regulation goal (2 x 2 x 3) interaction effect in the left amygdala for younger adults||||0.441
71115780|NCT03458910|141737984|SUPERIORITY|||||||0.621|||||||ANOVA|||time x condition x regulation goal (2 x 2 x 3) interaction effect in the left amygdala for older adults||||0.621
71115781|NCT03458910|141737985|SUPERIORITY|||||||0.19|||||||ANOVA|||time x condition x regulation goal (2 x 2 x 3) interaction effect in the right amygdala activity for younger adults||||0.190
71115782|NCT03458910|141737986|SUPERIORITY|||||||0.864|||||||ANOVA|||time x condition x regulation goal (2 x 2 x 3) interaction effect in the right amygdala activity for older adults||||0.864
71115783|NCT03458910|141737987|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Comparing acceptance rate of fair offers||||1.000
71115784|NCT03458910|141737987|SUPERIORITY|||||||0.716|||||||Wilcoxon (Mann-Whitney)|||Comparing acceptance rate of unfair offers||||0.716
71073995|NCT00662558|141656714|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.46||0.581||95.0|-0.65|1.16|||ANCOVA||The mean difference reported is the LS mean difference.|Index Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.16|-0.65|0.581
71073996|NCT00662558|141656715|SUPERIORITY_OR_OTHER_LEGACY|||||||0.614||95.0|||||Cochran-Mantel-Haenszel|||P-value reported is the overall p-value for Week 1.||||0.614
71073997|NCT00662558|141656715|SUPERIORITY_OR_OTHER_LEGACY|||||||0.786||95.0|||||Cochran-Mantel-Haenszel|||P-value reported is the overall p-value for Week 3.||||0.786
71073998|NCT00662558|141656715|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0|||||Cochran-Mantel-Haenszel|||P-value reported is the overall p-value for Week 6/ET.||||0.044
71073999|NCT00662558|141656716|SUPERIORITY_OR_OTHER_LEGACY|||||||0.87||95.0|||||Cochran-Mantel-Haenszel|||CMH tests using row mean score and adjusted for center was used to compare the two treatment groups.||||0.870
71074000|NCT00662558|141656717|SUPERIORITY_OR_OTHER_LEGACY|||||||0.545||95.0|||||Cochran-Mantel-Haenszel|||CMH tests using row mean score and adjusted for center was used to compare the two treatment groups.||||0.545
71074001|NCT00662558|141656718|SUPERIORITY_OR_OTHER_LEGACY|||||||0.218||95.0|||||Cochran-Mantel-Haenszel|||CMH test adjusted for center was used to compare the two treatment groups.||||0.218
71074002|NCT00783224|141656723|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||ANCOVA|||||||0.0001
71074003|NCT00783224|141656723|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||ANCOVA|||||||0.0001
71074004|NCT01711619|141656724|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Nominal alpha of 4% was predefined for the final analysis.|Fisher Exact|||Subjects with missing information were considered in the test and computation of the proportion for ITT.||||<0.0001
71074005|NCT01711619|141656725|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Nominal alpha of 5% was pre-defined for the final analysis.|Regression, Linear|||||||<0.0001
71074006|NCT01711619|141656726|SUPERIORITY_OR_OTHER|||||||0.0002||||||Nominal alpha of 5% was pre-defined for the final analysis.|Fisher Exact|||Subjects with missing information were considered in the test and computation for ITT.||||0.0002
71074007|NCT01711619|141656727|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Nominal alpha of 5% was pre-defined for the final analysis.|Fisher Exact|||Subjects with missing information were considered in the test and computation for ITT.||||<0.0001
71074008|NCT00475878|141656743|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64|STANDARD_ERROR_OF_MEAN|0.22||0.19|TWO_SIDED|95.0|0.33|1.24|||Chi-squared|||||1.24|.33|.19
71074009|NCT00475878|141656744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|2.16||0.18|TWO_SIDED|95.0|-2.79|5.84|||t-test, 2 sided|||||5.84|-2.79|.18
71074010|NCT02584959|141656763|OTHER||Difference in LS means|-2.32|||<|0.0001|TWO_SIDED|95.0|-2.895|-1.744|||Mixed Models Analysis|||The LS means, 95% CIs, and p-values were based on a mixed effect linear model with period, sequence ,use of prophylactic therapy with C1 INH at randomization, and treatment as fixed effects and subject nested within sequence as a random effect.||-1.744|-2.895|<0.0001
71074011|NCT02584959|141656765|OTHER||Difference in LS means|-2.323|||<|0.0001|TWO_SIDED|95.0|-2.969|-1.677|||Mixed Models Analysis|||The LS means, 95% CIs, and p-values were based on a mixed effect linear model with period, sequence ,use of prophylactic therapy with C1 INH at randomization, and treatment as fixed effects and subject nested within sequence as a random effect.||-1.677|-2.969|<0.0001
71074012|NCT02584959|141656768|OTHER||Difference in LS means|-4.881|||<|0.0001|TWO_SIDED|95.0|-6.113|-3.649|||Mixed Models Analysis|||The LS means, 95% CIs, and p-values were based on a mixed effect linear model with period, sequence ,use of prophylactic therapy with C1 INH at randomization, and treatment as fixed effects and subject nested within sequence as a random effect.||-3.649|-6.113|<0.0001
71074013|NCT02584959|141656769|OTHER||Difference in LS means|5.435|||<|0.0001|TWO_SIDED|95.0|3.981|6.889|||Mixed Models Analysis|||||6.889|3.981|<0.0001
71074014|NCT02584959|141656770|OTHER||Difference in LS means|-2.175|||<|0.0001|TWO_SIDED|95.0|-2.75|-1.599|||Mixed Models Analysis|||||-1.599|-2.750|<0.0001
71074015|NCT02584959|141656785|OTHER||Difference in LS means|-31.735||||0.0001|TWO_SIDED|95.0|-42.696|-20.773|||Mixed Models Analysis|||The Least Square means, 95% confidence intervals and p-values are based on mixed effect linear model with period, sequence, use of prophylactic therapy with C1 INH at randomization and treatment as fixed effects and subject nested within sequence as a random effect.||-20.773|-42.696|0.0001
71074016|NCT00195494|141656805|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.0|||<|0.001|||||||Fisher Exact||E+M (49.8%) - M (27.8%) creates the risk difference estimated value.|||||<0.001
71074017|NCT00195494|141656806|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.0|||<|0.001|||||||Fisher Exact||E+M (79.7%) - M (58.7%) creates the risk difference estimated value.|||||<0.001
71074018|NCT01217385|141656810|EQUIVALENCE|under the NULL, it is assume that there is no difference between a 40% decrease in TOI, and a less than 40% decrease or an increase in TOI in their ability to predict pCR+|Odds Ratio (OR)|4.667||||0.059|TWO_SIDED|95.0|0.95|23.04||5% alpha threshold for significance.|Regression, Logistic|||"This analysis will look at the ability of the % change in DOSI measured tumor Optical Index (TOI) from baseline to mid-therapy to predict pathologic response using logistic regression.~Pathologic response (dichotomized into responders and non-responders) will be used as the reference standard and %change in TOI ratio (dichotomized at -40%) will be used to estimate pCR (+/-)= alpha + beta1(%change TOI)"||23.04|0.95|0.059
71074019|NCT01217385|141656811|EQUIVALENCE|test for the equivalence of %change in TOI ratio (dichotomized at \<=-40%), between PR+ and PR- groups, with interaction|Slope|0.4463|STANDARD_ERROR_OF_MEAN|1.953||0.8193|TWO_SIDED|||||significance at alpha=0.05|Regression, Logistic|p-value represents the interaction between %TOI (dichotomized at \<=-40%), and PR status|Multivariate logistic regression model using % change in TOI ratio (T/N) (baseline to mid-therapy) dichotomized at -40%, PR status, and the corresponding interaction.|The Null is that the odd ratio is the same in both the PR+ and PR- subjects fro the model including %change in TOI form baseline to mid-therapy (dichotomized at \<=-40%), PR status (+/-) and the interaction between them.||||0.8193
71074020|NCT01217385|141656812|OTHER||Odds Ratio (OR)|16.5||||0.043|TWO_SIDED|95.0|1.09|250.15|||Regression, Logistic|||||250.15|1.09|0.043
71074021|NCT01217385|141656812|OTHER||Odds Ratio (OR)|2.86||||0.406|TWO_SIDED|95.0|0.24|33.9|||Regression, Logistic|||||33.90|0.24|0.406
71115785|NCT03458910|141737988|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||An independent t-test was performed to compare the two groups for dorsal anterior cingulate cortex activation.||||0.014
71074022|NCT02431806|141656857|SUPERIORITY||Least Squares (LS) Mean Difference|-0.38||||0.8035|TWO_SIDED|95.0|-3.41|2.64|||Mixed Model Repeated Measures (MMRM)||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.|||2.64|-3.41|0.8035
71074023|NCT02431806|141656857|SUPERIORITY||LS Mean Difference|0.26||||0.8681|TWO_SIDED|95.0|-2.8|3.31|||MMRM||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.|||3.31|-2.80|0.8681
71074024|NCT02431806|141656857|SUPERIORITY||LS Mean|-1.47||||0.3439|TWO_SIDED|95.0|-4.52|1.58|||MMRM||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.|||1.58|-4.52|0.3439
71074025|NCT02431806|141656858|SUPERIORITY||LS Mean Difference|0.02||||0.8788|TWO_SIDED|95.0|-0.25|0.29|||MMRM||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.|||0.29|-0.25|0.8788
71074026|NCT02431806|141656858|SUPERIORITY||LS Mean Difference|0.01||||0.923|TWO_SIDED|95.0|-0.26|0.29|||MMRM||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.|||0.29|-0.26|0.9230
71074027|NCT02431806|141656858|SUPERIORITY||LS Mean Difference|-0.15||||0.2895|TWO_SIDED|95.0|-0.42|0.13|||MMRM||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.|||0.13|-0.42|0.2895
71074028|NCT02502266|141656978|SUPERIORITY||Hazard Ratio (HR)|0.649|||||TWO_SIDED|95.0|0.424|0.995|||||The hazard ratio estimate compares Cediranib and Olaparib to chemotherapy. If Cediranib and Olaparib is superior, the hazard ratio is \<1.0.|Experimental regimens with at least a 17% reduction in the estimated PFS event rate (compared to standard chemotherapy) (HR estimate \< 0.83) were recommended for further evaluation in the phase III trial.||0.995|0.424|
71074029|NCT02502266|141656978|SUPERIORITY||Hazard Ratio (HR)|0.832|||||TWO_SIDED|95.0|0.539|1.284|||||The hazard ratio estimate compares Cediranib to chemotherapy. If Cediranib is superior, the hazard ratio is \<1.0.|Experimental regimens with at least a 17% reduction in the estimated PFS event rate (compared to standard chemotherapy) (HR estimate \< 0.83) were recommended for further evaluation in the phase III trial.||1.284|0.539|
71074030|NCT02502266|141656978|SUPERIORITY||Hazard Ratio (HR)|1.149|||||TWO_SIDED|95.0|0.745|1.773|||||The hazard ratio estimate compares Olaparib to chemotherapy. If Olaparib is superior, the hazard ratio is \<1.0.|Experimental regimens with at least a 17% reduction in the estimated PFS event rate (compared to standard chemotherapy) (HR estimate \< 0.83) were recommended for further evaluation in the phase III trial.||1.773|0.745|
71074031|NCT02502266|141656979|SUPERIORITY||Hazard Ratio (HR)|0.796||||0.145|TWO_SIDED|98.0|0.597|1.06||The log rank test was stratified by the factors provided at randomization|Log Rank||The hazard ratio estimate compares Cediranib and Olaparib to chemotherapy. If Cediranib and Olaparib is superior, the hazard ratio is \<1.0.|Arm IV was suspended for futility at the end of Phase 2 analysis, so was not analyzed at the final analysis.||1.060|0.597|0.145
71074032|NCT02502266|141656979|SUPERIORITY||Hazard Ratio (HR)|0.972||||1|TWO_SIDED|98.0|0.726|1.0|||Log Rank|The log rank test was stratified by the factors provided at randomization.|The hazard ratio estimate compares Cediranib to chemotherapy. If Cediranib is superior, the hazard ratio is \<1.0.|Arm IV was suspended for futility at the end of Phase 2 analysis, so was not analyzed at the final analysis.||1.00|0.726|1.0
71074033|NCT02502266|141656980|SUPERIORITY||Hazard Ratio (HR)|1.027|||||TWO_SIDED|98.0|0.771|1.368||No p-values are provided because testing each of these null hypotheses was conditioned on first rejecting hypothesis concerning PFS.|||The hazard ratio estimate compares Cediranib and Olaparib to chemotherapy. If Cediranib and Olaparib is superior, the hazard ratio is \<1.0.|Arm IV was suspended for futility at the end of Phase 2 analysis, so was not analyzed at the final analysis.||1.368|0.771|
71115786|NCT03458910|141737988|SUPERIORITY|||||||0.059|||||||t-test, 2 sided|||An independent t-test was performed to compare the two groups for anterior insula activation.||||0.059
71115787|NCT03458910|141737989|SUPERIORITY|||||||0.144|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||.144
71115788|NCT03458910|141737989|SUPERIORITY|||||||0.653||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|||||||0.653
71115789|NCT03458910|141737990|SUPERIORITY|||||||0.288|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||.288
71115790|NCT03458910|141737990|SUPERIORITY|||||||0.191||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.191
71115791|NCT03458910|141737991|SUPERIORITY|||||||0.894|||||||ANOVA|||||||0.894
71115792|NCT03458910|141737991|SUPERIORITY|||||||0.425||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.425
71115793|NCT03458910|141737992|SUPERIORITY|||||||0.916|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.916
71115794|NCT03458910|141737992|SUPERIORITY|||||||0.235||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.235
71115795|NCT03458910|141737993|SUPERIORITY|||||||0.462|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.462
71115796|NCT03458910|141737993|SUPERIORITY|||||||0.468||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.468
71115797|NCT03458910|141737994|SUPERIORITY|||||||0.481|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.481
70940394|NCT00141271|141380811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7100
71074034|NCT02502266|141656980|OTHER|No p-values are provided because testing each of these null hypotheses was conditioned on first rejecting hypothesis concerning PFS.|Hazard Ratio (HR)|1.06|||||TWO_SIDED|98.0|0.795|1.413||No p-values are provided because testing each of these null hypotheses was conditioned on first rejecting hypothesis concerning PFS.|||The hazard ratio estimate compares Cediranib to chemotherapy. If Cediranib is superior, the hazard ratio is \<1.0.|Arm IV was suspended for futility at the end of Phase 2 analysis, so was not analyzed at the final analysis.||1.413|0.795|
71074035|NCT02921750|141656988|NON_INFERIORITY|In this non-inferiority study the primary efficacy analysis included constructing a two sided 95% confidence interval, using Fisher's non-parametric permutation test, for between-treatment differences (Exufiber - Aquacel Extra) in the mean percentage area change from baseline to 6 weeks. This means that if the lower limit of this confidence interval was found to be greater than 12%, non-inferiority will be established.|Mean Difference (Final Values)|-29.4||||0.093|TWO_SIDED|95.0|-63.5|3.2|||Fisher Exact|||||3.2|-63.5|0.093
71074036|NCT02102100|141657000|OTHER||Mean Difference (Net)|0.9436|||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||Least square means and standard errors were calculated to describe the patterns of means for each outcome. Effect slices were tested to explain significant interactions in the models. Pairwise comparisons of least square means were used to describe significant main effects.||||<.0001
71074037|NCT00328094|141657001|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.29||||0.23|TWO_SIDED|95.0|0.85|1.97|||Chi-squared|||||1.97|0.85|0.23
71074038|NCT00985426|141657013|NON_INFERIORITY|Non-inferiority is achieved if the lower limit of the two-sided 95% CI was greater than -10%.|SPR Difference (%)|8.0|||||TWO_SIDED|95.0|1.7|14.3|||||SPR difference = SPR for HEPLISAV-B minus SPR for Engerix-B.|Two-sided 95% confidence intervals (CIs) of the difference in seroprotection rates (SPR) between the HEPLISAV-B group and the Engerix-B group at 28 weeks was computed using the Newcombe score method with continuity correction.||14.3|1.7|
71074039|NCT00985426|141657013|SUPERIORITY|Superiority is achieved if the lower limit of the two-sided 95% CI was greater than 0%.|SPR Difference (%)|8.0|||||TWO_SIDED|95.0|1.7|14.3||||||Two-sided 95% CIs of the difference in SPR between the HEPLISAV-B group and the Engerix-B group at 28 weeks was computed using the Newcombe score method with continuity correction.||14.3|1.7|
71074040|NCT00985426|141657018|SUPERIORITY|Superiority is achieved if the lower limit of the two-sided 95% CI was greater than 0%.|SPR Difference (%)|12.9|||||TWO_SIDED|95.0|4.4|21.2||||||Two-sided 95% CIs of the difference in SPRs between the HEPLISAV group and the Engerix-B group at 28 weeks was computed using the Newcombe score method with continuity correction.||21.2|4.4|
71074041|NCT02327013|141657019|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|1.8||0.9723|TWO_SIDED|95.0|-3.6|3.5|||weighed z-score|Equally weighed LS z-score, combining results from stagewise MMRM, was compared to standard normal distribution.||The mean difference between treatment groups was estimated based on LS means for the treatment-by-visit interaction in stagewise MMRM analyses. In each stage, the REML-based MMRM model included site ID (stage 1 only), visit, treatment (placebo, vortioxetine 10mg, vortioxetine 20mg), baseline (for the stage) AISRS total score, treatment-by-visit interaction, and baseline (stage) AISRS total score-by-visit interaction, with an unstructured covariance structure to model the within-patient errors.||3.5|-3.6|0.9723
70853490|NCT01375075|141195098|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61|STANDARD_ERROR_OF_MEAN|0.61||0.317|TWO_SIDED|90.0|-0.4|1.63|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.63|-0.40|0.317
71074042|NCT02327013|141657019|SUPERIORITY|The mean difference between treatment groups was estimated based on LS means for the treatment-by-visit interaction in stagewise MMRM analyses. In each stage, the REML-based MMRM model included site ID (stage 1 only), visit, treatment (placebo, vortioxetine 10mg, vortioxetine 20mg), baseline (for the stage) AISRS total score, treatment-by-visit interaction, and baseline (stage) AISRS total score-by-visit interaction, with an unstructured covariance structure to model the within-patient errors.|Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|1.9||0.601|TWO_SIDED|95.0|-2.8|4.8|||weighed z-score|Equally weighed LS z-score, combining results from stagewise MMRM, was compared to standard normal distribution.||||4.8|-2.8|0.6010
71074043|NCT00355706|141657104|SUPERIORITY_OR_OTHER_LEGACY|||||||0.964||95.0|||||ANOVA|||||||0.964
71074044|NCT00355706|141657105|SUPERIORITY_OR_OTHER_LEGACY|||||||0.892||95.0|||||ANOVA|||||||0.892
71074045|NCT00355706|141657106|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56||95.0|||||ANOVA|||||||0.560
71074046|NCT01642485|141657117|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 1 sided|||The effect of insulin, C-peptide and glucose on QTcF was investigated using linear mixed effect concentration-response models with the double difference of QTcF (difference to time matched placebo of the change from average baseline) as dependent variable and up to two of the variables change from time matched placebo in insulin, C-peptide and glucose as covariates.||||0.05
71074047|NCT01642485|141657118|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 1 sided|||The relevant confirmatory null hypotheses could all be rejected on the 5% level (one sided), i.e. a difference in QTcF between continental breakfast and placebo; between FDA breakfast and placebo could be ascertained.||||0.05
71074048|NCT01642485|141657118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.9|||||TWO_SIDED|90.0|-10.4|-5.5||||||||-5.5|-10.4|
71074049|NCT01642485|141657118|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-6.8|||||TWO_SIDED|90.0|-9.3|-4.3||||||||-4.3|-9.3|
71074050|NCT01313494|141657157|SUPERIORITY_OR_OTHER||LSM Difference|0.071|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.046|0.095|||Repeated measures ANCOVA|Independent variables: treatment, baseline value of pre-bronchodilator FEV1, time and a treatment-by-time interaction.||The primary endpoint was tested in a confirmatory manner with a 2-sided significance level of 5%.||0.095|0.046|<0.0001
71074051|NCT04007107|141657198|OTHER|Comparison|Estimated treatment difference|30.7|||<|0.0001|TWO_SIDED|95.0|26.6|34.8|||ANOVA|||The intensity of pain was analysed by a fixed analysis of variance model with VAS score as the dependent variable, and product, injection side (right side, left side), injection number (first injection, second injection), and participant as fixed effects.||34.8|26.6|<0.0001
71074052|NCT04068688|141657199|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
71074053|NCT04068688|141657199|OTHER|||||||0.914|||||||Wilcoxon (Mann-Whitney)|||||||0.914
71115798|NCT03458910|141737994|SUPERIORITY|||||||0.159||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.159
71115799|NCT03458910|141737995|SUPERIORITY|||||||0.602|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.602
71115800|NCT03458910|141737995|SUPERIORITY|||||||0.562||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.562
71115801|NCT03458910|141737996|SUPERIORITY|||||||0.697|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.697
71115802|NCT03458910|141737996|SUPERIORITY|||||||0.901||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.901
71115803|NCT03458910|141737997|SUPERIORITY|||||||0.516|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction||||||0.516
71074054|NCT04068688|141657200|OTHER|||||||0.655|||||||Wilcoxon (Mann-Whitney)|||||||0.655
71115804|NCT03458910|141737998|SUPERIORITY|||||||0.944|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction||||||0.944
71115805|NCT03458910|141737999|SUPERIORITY|||||||0.285|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction||||||0.285
71115806|NCT03458910|141738000|SUPERIORITY|||||||0.807|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction||||||0.807
71115807|NCT03458910|141738001|SUPERIORITY||||||<|0.001|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction||||||<0.001
71115808|NCT03458910|141738002|SUPERIORITY|||||||0.74|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction||||||0.740
71115809|NCT03458910|141738003|SUPERIORITY|||||||0.083|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.083
71115810|NCT03458910|141738004|SUPERIORITY|||||||0.176|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.176
71074055|NCT04068688|141657200|OTHER|||||||0.564|||||||Wilcoxon (Mann-Whitney)|||||||0.564
71074056|NCT04068688|141657201|OTHER|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
71074057|NCT04068688|141657201|OTHER|||||||0.705|||||||Wilcoxon (Mann-Whitney)|||||||0.705
71074058|NCT04068688|141657202|OTHER|||||||0.096|||||||Wilcoxon (Mann-Whitney)|||||||0.096
71074059|NCT04068688|141657202|OTHER|||||||0.732|||||||Wilcoxon (Mann-Whitney)|||||||0.732
71074060|NCT04068688|141657203|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
71074061|NCT04068688|141657203|OTHER|||||||0.705|||||||Wilcoxon (Mann-Whitney)|||||||0.705
71074062|NCT04068688|141657204|OTHER|||||||0.442|||||||Wilcoxon (Mann-Whitney)|||||||0.442
71074063|NCT04068688|141657204|OTHER|||||||0.458|||||||Wilcoxon (Mann-Whitney)|||||||0.458
71074064|NCT04068688|141657205|OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.35
71074065|NCT04068688|141657205|OTHER|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
71074066|NCT04068688|141657209|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
71074067|NCT04068688|141657210|OTHER|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||||||0.084
71074068|NCT04068688|141657211|OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
71074069|NCT04068688|141657211|OTHER|||||||0.171|||||||Wilcoxon (Mann-Whitney)|||||||0.171
71074070|NCT04068688|141657212|OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
71074071|NCT04068688|141657212|OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|||||||0.049
71074072|NCT04068688|141657216|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71074073|NCT04068688|141657216|OTHER|||||||0.139|||||||Wilcoxon (Mann-Whitney)|||||||0.139
71115811|NCT03458910|141738005|SUPERIORITY|||||||0.325|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.325
71115812|NCT03458910|141738006|SUPERIORITY|||||||0.751|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.751
71074074|NCT04679051|141657221|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||Two-tailed paired t-tests were used to compare variables between time in bed conditions.||||0.36
71074075|NCT04679051|141657222|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||Paired t-test comparing the two time in bed protocols.||||0.51
71074076|NCT04679051|141657223|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Paired t-test comparing peak forearm blood flow between sleep protocols.||||0.03
71074077|NCT04679051|141657224|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||Paired t-test used to compare carotid-femoral pulse wave velocity (index of arterial stiffness) between sleep protocols.||||0.29
71074078|NCT04679051|141657225|SUPERIORITY||||||<|0.001||||||Null hypothesis is that there was no difference in change of spatial ability following one day of aerobic exercise. The ANOVA test was performed with a significance level of 0.05 (two-sided).|ANOVA|||A two-way repeated measures ANOVA was used to evaluate the main effect of exercise (before vs. after exercise) on Manikin throughput scores.||||<0.001
71074079|NCT04679051|141657226|SUPERIORITY|||||||0.04||||||Null hypothesis is that there was no difference in the change of executive function following one day of aerobic exercise. The ANOVA test was performed with a significance level of 0.05 (two-sided).|ANOVA|||A two-way repeated measures ANOVA was used to evaluate the main effect of exercise (before vs. after exercise) on the number of correct answers during a Stroop color-word test.||||0.04
71074080|NCT04679051|141657227|SUPERIORITY|||||||0.02||||||Null hypothesis is that there was no difference in change of spatial ability following one day of aerobic exercise. The ANOVA test was performed with a significance level of 0.05 (two-sided).|ANOVA|||A two-way repeated measures ANOVA was used to evaluate the main effect of exercise (before vs. after exercise) on throughput scores from a Switching task.||||0.02
71074081|NCT02332239|141657228|SUPERIORITY||Mean Difference (Final Values)|-7.48|STANDARD_ERROR_OF_MEAN|4.11||0.07|TWO_SIDED||||||Mixed effects longitudinal regression||d=0.37|BDI Score where baseline \>=20: 8 week||||0.07
71074082|NCT02332239|141657229|SUPERIORITY||Median Difference (Final Values)|-7.29|STANDARD_ERROR_OF_MEAN|2.62||0.01|TWO_SIDED||||||quantile regression models|Controlled for baseline and gender|d=0.46|CTS Score where baseline \>=4: 8 week||||0.01
71115813|NCT03458910|141738007|SUPERIORITY|||||||0.011|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.011
71115814|NCT03458910|141738008|SUPERIORITY|||||||0.885|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.885
71115815|NCT03458910|141738009|SUPERIORITY|||||||0.259||||||p-value reflects time x condition interaction|ANOVA|||2 (time) x 2 (condition) ANOVA to test effects of time, condition, and time x condition interaction||||0.259
71115816|NCT03458910|141738010|SUPERIORITY|||||||0.000146||||||p-value reflects time x condition interaction|ANOVA|||2 (time) x 2 (condition) ANOVA to test effects of time, condition, and time x condition interaction||||0.000146
71074083|NCT02332239|141657232|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||||||0.33
71074084|NCT00396877|141657235|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|11.1||||0.434|TWO_SIDED|95.0|-19.2|33.6||The a-priori threshold for statistical significance was \< 0.035 reflecting the adjustment for interim analyses. No other adjustment for multiplicity was made.|Log Rank|A two-sided log-rank test was used.|The Relative Risk Reduction (Clopidogrel versus placebo) and its corresponding 95% confidence interval were estimated using Cox's proportional hazards model.|"Due to the limited knowledge in this population, 3 interim analyses were performed at approximatively 40%, 60%, 80% and 100% of of the maximum number of 172 required primary efficacy events to evaluate the effect of Clopidogrel on the primary endpoint with the potential to end the trial in case of a clear efficacy advantage for Clopidogrel.~The study was designed with 80% power and an overall type I error rate of 5%."||33.6|-19.2|0.4340
71074085|NCT03422159|141657246|NON_INFERIORITY|Based on the results of the preliminary study of Marik et al, 5 we projected that the combination of ascorbic acid, thiamine, and hydrocortisone could reduce time to vasopressor discontinuation from 54 (+/-30 hours) vs 30 hours. For the additional primary outcome, we projected a greater change of SOFA score of 4 (+/-3) vs 2. Assuming a type 1 error of 5% (alpha of 0.05) and a power of 80%, this study would require a sample size of 94 patients.|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71074086|NCT02631070|141657254|SUPERIORITY||Common Risk Difference on Response Rate|24.56|||<|0.0001|TWO_SIDED|95.0|14.48|34.64|||Cochran-Mantel-Haenszel|||||34.64|14.48|<0.0001
71074087|NCT02631070|141657254|SUPERIORITY||Odds Ratio (OR)|5.065|||<|0.0001|TWO_SIDED|95.0|2.278|11.259|||Cochran-Mantel-Haenszel|||||11.259|2.278|<0.0001
71115817|NCT03458910|141738011|SUPERIORITY|||||||0.463||||||time point x group (2 way) interaction|ANOVA|||||||0.463
71115818|NCT03458910|141738012|SUPERIORITY|||||||0.99||||||time point x group (2 way) interaction|ANOVA|||||||0.990
71074088|NCT02631070|141657255|SUPERIORITY||Common Risk Difference on Response Rate|20.0||||0.0002|TWO_SIDED|95.0|10.92|29.08|||Cochran-Mantel-Haenszel|||||29.08|10.92|0.0002
71074089|NCT02631070|141657255|SUPERIORITY||Odds Ratio (OR)|5.071||||0.0002|TWO_SIDED|95.0|2.002|12.844|||Cochran-Mantel-Haenszel|||||12.844|2.002|0.0002
71115819|NCT03458910|141738013|SUPERIORITY|||||||0.034||||||time point x group (2 way) interaction|ANOVA|||||||0.034
71115820|NCT03458910|141738014|SUPERIORITY|||||||0.398||||||time point x group (2 way) interaction|ANOVA|||||||0.398
71115821|NCT03458910|141738015|SUPERIORITY|||||||0.113||||||time point x group (2 way) interaction|ANOVA|||||||0.113
71115822|NCT03458910|141738016|SUPERIORITY|||||||0.637||||||time point x group (2 way) interaction|ANOVA|||||||0.637
71115823|NCT03458910|141738017|SUPERIORITY|time x condition interaction in CRP for younger adults||||||0.133|||||||ANOVA|||||||0.133
71115824|NCT03458910|141738018|SUPERIORITY|time x condition interaction in CRP for older adults||||||0.402|||||||ANOVA|||||||0.402
71115825|NCT03458910|141738019|SUPERIORITY|time x condition interaction in cytokine IL-1b for younger adults||||||0.236||||||p value for time x condition interaction effect|ANOVA|||||||0.236
71074090|NCT02631070|141657256|SUPERIORITY||Common Risk Difference on Response Rate|21.37||||0.0003|TWO_SIDED|95.0|11.23|31.51|||Cochran-Mantel-Haenszel|||||31.51|11.23|0.0003
71115826|NCT03458910|141738020|SUPERIORITY|time x condition interaction in cytokine IL-1b for older adults||||||0.6||||||p value for time x condition interaction effect|ANOVA|||||||0.600
71115827|NCT03458910|141738021|SUPERIORITY|time x condition interaction in cytokine IL-6 for younger adults||||||0.788||||||p value for time x condition interaction effect|ANOVA|||||||0.788
71115828|NCT03458910|141738022|SUPERIORITY|time x condition interaction in cytokine IL-6 for older adults||||||0.917||||||p value for time x condition interaction effect|ANOVA|||||||0.917
71115829|NCT03458910|141738023|SUPERIORITY|time x condition interaction in cytokine IL-8 for younger adults||||||0.844||||||p value for time x condition interaction effect|ANOVA|||||||0.844
71115830|NCT03458910|141738024|SUPERIORITY|time x condition interaction in cytokine IL-8 for older adults||||||0.75||||||p value for time x condition interaction effect|ANOVA|||||||0.750
71115831|NCT03458910|141738025|SUPERIORITY|time x condition interaction in cytokine TNF-a for younger adults||||||0.074||||||p value for time x condition interaction effect|ANOVA|||||||0.074
71115832|NCT03458910|141738026|SUPERIORITY|time x condition interaction in cytokine TNF-a for older adults||||||0.0505||||||p value for time x condition interaction effect|ANOVA|||||||0.0505
71115833|NCT03458910|141738041|SUPERIORITY|||||||0.022|||||||t-test, 2 sided|||An independent t-test was performed to compare the two groups.||||0.022
71115834|NCT03458910|141738042|SUPERIORITY|||||||0.455|||||||t-test, 2 sided|||An independent t-test was performed to compare the two groups.||||0.455
70853491|NCT01375075|141195100|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.13||0.888|TWO_SIDED|90.0|-0.24|0.2|||ANCOVA|Treatment was included in the model as fixed effects, baseline hsCRP as covariate.||||0.20|-0.24|0.888
71074091|NCT02631070|141657256|SUPERIORITY||Odds Ratio (OR)|4.045||||0.0003|TWO_SIDED|95.0|1.827|8.956|||Cochran-Mantel-Haenszel|||||8.956|1.827|0.0003
71074092|NCT02631070|141657257|SUPERIORITY||Common Risk Difference on Response Rate|29.55|||<|0.0001|TWO_SIDED|95.0|18.73|40.36|||Cochran-Mantel-Haenszel|||||40.36|18.73|<0.0001
71074093|NCT02631070|141657257|SUPERIORITY||Odds Ratio (OR)|5.306|||<|0.0001|TWO_SIDED|95.0|2.526|11.146|||Cochran-Mantel-Haenszel|||||11.146|2.526|<0.0001
71074094|NCT02631070|141657259|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 1 -24||||<0.0001
71074095|NCT02631070|141657259|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 1 - 48||||<0.0001
71074096|NCT02631070|141657260|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Week 1 Through Week 24||||<0.0001
71074097|NCT02631070|141657260|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Week 1 Through Week 48||||<0.0001
71115835|NCT03458910|141738043|SUPERIORITY|||||||0.022|||||||ANOVA|||A 2 (time: pre, post) X 2 (condition: HRV-increase, HRV-decrease) ANOVA was performed.||||0.022
71115836|NCT03458910|141738044|SUPERIORITY|||||||0.455|||||||ANOVA|||A 2 (time: pre, post) X 2 (condition: HRV-increase, HRV-decrease) ANOVA was performed.||||0.455
71115837|NCT03458910|141738045|SUPERIORITY|||||||0.462||||||time point x group (2 way) interaction|ANOVA|||||||0.462
70940395|NCT00141271|141380812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1836||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1836
70940396|NCT00141271|141380812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1374||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1374
70940397|NCT00141271|141380813|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9237||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.9237
70940398|NCT00141271|141380813|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3786||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.3786
71074098|NCT02631070|141657261|SUPERIORITY||Hazard Ratio (HR)|0.446||||0.0445|TWO_SIDED|95.0|0.196|1.013|||Log Rank||HR is from the Cox proportional hazards model|||1.013|0.196|0.0445
71074099|NCT02631070|141657262|SUPERIORITY||Hazard Ratio (HR)|0.784||||0.5121|TWO_SIDED|95.0|0.362|1.699|||Log Rank||HR is from the Cox proportional hazards model|||1.699|0.362|0.5121
71115838|NCT03458910|141738046|SUPERIORITY|||||||0.305||||||time point x group (2 way) interaction|ANOVA|||||||0.305
70853492|NCT01375075|141195100|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.13||0.939|TWO_SIDED|90.0|-0.21|0.23|||ANCOVA|Treatment was included in the model as fixed effects, baseline hsCRP as covariate.||||0.23|-0.21|0.939
71074100|NCT02631070|141657264|SUPERIORITY|||||||0.2382|||||||Cochran-Mantel-Haenszel|||Week 1 -24||||0.2382
71074101|NCT02631070|141657264|SUPERIORITY|||||||0.5127|||||||Cochran-Mantel-Haenszel|||Week 1 - 48||||0.5127
71074102|NCT02631070|141657265|SUPERIORITY|||||||0.5479|||||||Cochran-Mantel-Haenszel|||Week 1 -24||||0.5479
71074103|NCT02631070|141657265|SUPERIORITY|||||||0.298|||||||Cochran-Mantel-Haenszel|||Week 1 - 48||||0.2980
71074104|NCT02631070|141657266|SUPERIORITY||LS Mean Difference|-229.1|STANDARD_ERROR_OF_MEAN|74.43||0.0024|TWO_SIDED|95.0|-375.8|-82.4|||ANCOVA|||Week 9 Through 24||-82.4|-375.8|0.0024
71115839|NCT03458910|141738047|SUPERIORITY|||||||0.804||||||time point x group (2 way) interaction|ANOVA|||||||0.804
71115840|NCT03458910|141738048|SUPERIORITY|||||||0.141||||||time point x group (2 way) interaction|ANOVA|||||||0.141
71115841|NCT03458910|141738049|SUPERIORITY|||||||0.292||||||time point x group(2 way) interaction|ANOVA|||||||0.292
70940399|NCT00141271|141380814|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4624||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4624
70940400|NCT00141271|141380814|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5971|||||||ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.5971
70940401|NCT00141271|141380815|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1378||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1378
71074105|NCT02631070|141657266|SUPERIORITY||LS Mean Difference|-319.5|STANDARD_ERROR_OF_MEAN|144.57||0.0294|TWO_SIDED|95.0|-606.3|-32.7|||ANCOVA|||Week 33 Through 48||-32.7|-606.3|0.0294
71115842|NCT03458910|141738050|SUPERIORITY|||||||0.905||||||time point x group (2 way) interaction|ANOVA|||||||0.905
71115843|NCT03458910|141738051|SUPERIORITY|||||||0.641||||||p value for time x condition x error type interaction effect|ANOVA|||time x condition x error type interaction in Sustained Attention to Response Task (SART) for younger adults||||0.641
71115844|NCT03458910|141738052|SUPERIORITY|||||||0.813||||||p value for time x condition x error type interaction effect|ANOVA|||time x condition x error type interaction in Sustained Attention to Response Task (SART) for older adults||||0.813
71115845|NCT03458910|141738053|SUPERIORITY|||||||0.695|||||||ANOVA|||Hits during recognition task for younger adults||||.695
71115846|NCT03458910|141738054|SUPERIORITY|||||||0.27|||||||ANOVA|||Hits during recognition task for older adults||||.270
71115847|NCT03458910|141738055|SUPERIORITY|||||||0.102|||||||ANOVA|||False alarms during recognition task for younger adults||||.102
71115848|NCT03458910|141738056|SUPERIORITY|||||||0.257|||||||ANOVA|||False alarms during recognition task for older adults||||.257
71115849|NCT03458910|141738057|SUPERIORITY|||||||0.067|||||||ANOVA|||Group difference for recall for younger adults||||.067
71115850|NCT03458910|141738058|SUPERIORITY|||||||0.117|||||||ANOVA|||Group difference for recall for older adults||||.117
71115851|NCT03458910|141738059|SUPERIORITY|||||||0.558||||||p value for time x condition interaction effect|ANOVA|||time x condition x collection interaction in cortisol levels for younger adults||||0.558
71115852|NCT01450696|141738088|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||0.2401|TWO_SIDED|95.0|0.86|1.78|||Log Rank|||Stratified analysis included stratum of creatinine clearance (45 to 59 milliliters per minute \[mL/min\] and greater than or equal to \[≥\] 60 mL/min). Hazard ratio was estimated by Cox regression.||1.78|0.86|0.2401
71115853|NCT01450696|141738088|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.1285|TWO_SIDED|95.0|0.92|1.88|||Log Rank|||Unstratified analysis. Hazard ratio was estimated by Cox regression.||1.88|0.92|0.1285
71115854|NCT01450696|141738090|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9931|TWO_SIDED|95.0|0.49|2.04|||Log Rank|||Stratified analysis included stratum of creatinine clearance (45 to 59 mL/min and ≥60 mL/min). Hazard ratio was estimated by Cox regression.||2.04|0.49|0.9931
71115855|NCT01450696|141738090|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.9458|TWO_SIDED|95.0|0.52|2.02|||Log Rank|||Unstratified analysis. Hazard ratio was estimated by Cox regression.||2.02|0.52|0.9458
71115856|NCT01450696|141738092|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.6759|TWO_SIDED|95.0|0.63|2.02|||Log Rank|||Stratified analysis included stratum of creatinine clearance (45 to 59 mL/min and ≥60 mL/min). Hazard ratio was estimated by Cox regression.||2.02|0.63|0.6759
71115857|NCT01450696|141738092|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.5764|TWO_SIDED|95.0|0.67|2.05|||Log Rank|||Unstratified analysis. Hazard ratio was estimated by Cox regression.||2.05|0.67|0.5764
70853493|NCT01375075|141195100|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.13||0.296|TWO_SIDED|90.0|-0.08|0.36|||ANCOVA|Treatment was included in the model as fixed effects, baseline hsCRP as covariate.||||0.36|-0.08|0.296
70940402|NCT00141271|141380815|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7665||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7665
70940403|NCT00141271|141380816|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4767||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.4767
70940404|NCT00141271|141380816|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2066||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.2066
70940405|NCT00141271|141380817|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1667||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1667
70940406|NCT00141271|141380817|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6727||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.6727
71074106|NCT02631070|141657267|SUPERIORITY||LS Mean Difference|-41.0|STANDARD_ERROR_OF_MEAN|40.18||0.3087|TWO_SIDED|95.0|-120.3|38.2|||ANCOVA|||Weeks 9 Through 24||38.2|-120.3|0.3087
70940407|NCT00141271|141380818|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7019||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7019
70940408|NCT00141271|141380818|SUPERIORITY_OR_OTHER_LEGACY|||||||0.102||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1020
70940409|NCT00141271|141380819|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4749||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4749
70940410|NCT00141271|141380819|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4491||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4491
71074107|NCT02631070|141657267|SUPERIORITY||LS Mean Difference|-24.9|STANDARD_ERROR_OF_MEAN|93.42||0.7903|TWO_SIDED|95.0|-210.7|160.8|||ANCOVA|||Weeks 33 Through 48||160.8|-210.7|0.7903
71074108|NCT02631070|141657272|SUPERIORITY||Hazard Ratio (HR)|0.986||||0.958|TWO_SIDED|95.0|0.595|1.636|||Log Rank||HR is from the Cox proportional hazards model|||1.636|0.595|0.9580
71074109|NCT01153620|141657306|SUPERIORITY_OR_OTHER||||||=|0.006||95.0|||||Wilcoxon (Mann-Whitney)|||||||=0.006
71074110|NCT01273155|141657372|OTHER|Belinostat|Kendall's Tau|0.096||||0.327|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.327
71074111|NCT01273155|141657372|OTHER|Belinostat glucuronide|Kendall's Tau|-0.178||||0.063|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.063
71074112|NCT01273155|141657372|OTHER|Methyl belinostat|Kendall's Tau|0.382|||<|0.001|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||<0.001
71074113|NCT01273155|141657372|OTHER|M21|Kendall's Tau|0.253||||0.009|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.009
71074114|NCT01273155|141657372|OTHER|M24|Kendall's Tau|-0.278||||0.004|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.004
71074115|NCT01273155|141657372|OTHER|M26|Kendall's Tau|0.098||||0.312|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.312
71074116|NCT01273155|141657373|OTHER|Belinostat|Kendall's Tau|0.215||||0.025|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.025
71074117|NCT01273155|141657373|OTHER|Methyl belinostat|Kendall's Tau|0.426|||<|0.001|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||<0.001
71074118|NCT01273155|141657373|OTHER|M21|Kendall's Tau|0.337|||<|0.001|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||<0.001
70940411|NCT00141271|141380820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4398||||||For all efficacy analyses, no multiple comparisons adjustments were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4398
70940412|NCT00141271|141380820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3331||||||For all efficacy analyses, no multiple comparisons adjustments were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.3331
70940413|NCT00141271|141380821|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2763||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.2763
71074119|NCT01273155|141657373|OTHER|M24|Kendall's Tau|-0.061||||0.524|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.524
71074120|NCT01273155|141657373|OTHER|M26|Kendall's Tau|0.246||||0.01|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.010
71074121|NCT01273155|141657374|OTHER||Kendall's Tau|0.057||||0.548|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.548
71074122|NCT01273155|141657375|OTHER|Belinostat|Kendall's Tau|0.091||||0.34|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.340
71074123|NCT01273155|141657375|OTHER|Belinostat glucuronide|Kendall's Tau|-0.216||||0.023|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.023
71074124|NCT01273155|141657375|OTHER|Methyl belinostat|Kendall's Tau|0.268||||0.005|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.005
71074125|NCT01273155|141657375|OTHER|M21|Kendall's Tau|0.242||||0.011|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.011
71074126|NCT01273155|141657375|OTHER|M24|Kendall's Tau|-0.114||||0.231|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.231
71074127|NCT01273155|141657375|OTHER|M26|Kendall's Tau|0.22||||0.021|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.021
71074128|NCT01273155|141657376|OTHER||Kendall's Tau|-0.216||||0.023|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.023
71074129|NCT01273155|141657377|OTHER||Kendall's Tau|0.06||||0.531|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.531
71074130|NCT01273155|141657378|OTHER|Belinostat glucuronide/belinostat|Kendall's Tau|-0.224||||0.023|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.023
71074131|NCT01273155|141657378|OTHER|Methyl belinostat/belinostat|Kendall's Tau|0.295||||0.011|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.011
71115858|NCT01450696|141738093|SUPERIORITY_OR_OTHER||Difference in response rates|-7.58||||0.5402|TWO_SIDED|95.0|-31.75|16.6|||Chi-squared|||The 95% CI for difference in response rates was constructed using the normal approximation to the binomial distribution.||16.60|-31.75|0.5402
71115859|NCT01450696|141738093|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74|||||TWO_SIDED|95.0|0.28|1.96||||||||1.96|0.28|
71115860|NCT03115827|141738185|OTHER|||||||0.6|||||||t-test, 2 sided|||||||0.6
71115861|NCT04590404|141738200|SUPERIORITY||Odds Ratio (OR)|1.18||||0.461|TWO_SIDED|95.0|0.76|1.82|||Regression, Logistic|Adjusted for arm, randomization strata (cigarettes/day (CPD), insurance category, cardiac admission, NMR category), \& plan to quit after discharge||The primary outcome was biochemically-verified self-reported 7-day point prevalence abstinence (7dPPA) at 6 months. We modeled outcomes using logistic regression adjusted for randomization stratification factors and plan to quit (stay quit vs. try).||1.82|0.76|0.461
71115862|NCT00683930|141738232|SUPERIORITY_OR_OTHER||Treatment difference in response rate|5.1||||0.6558||97.5|-17.4|27.6|||Fisher Exact|Alpha = 0.025||||27.6|-17.4|0.6558
71115863|NCT02152371|141738251|SUPERIORITY_OR_OTHER_LEGACY||LS Means Diff|-0.77|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.97|-0.56|||Mixed Model for Repeated Measures (MMRM)|||||-0.56|-0.97|<.001
71115864|NCT02152371|141738252|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-16.73|STANDARD_ERROR_OF_MEAN|4.72|<|0.001|TWO_SIDED|95.0|-26.02|-7.44|||Mixed Models Analysis|||||-7.44|-26.02|<.001
71115865|NCT02152371|141738253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-8.06|STANDARD_ERROR_OF_MEAN|2.95||0.007|TWO_SIDED|95.0|-13.87|-2.25|||Mixed Models Analysis|||Pre-Morning Meal||-2.25|-13.87|.007
71074132|NCT01273155|141657378|OTHER|M21/belinostat|Kendall's Tau|0.335||||0.004|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.004
71074133|NCT01273155|141657378|OTHER|M24/belinostat|Kendall's Tau|-0.24||||0.037|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.037
71074134|NCT01273155|141657378|OTHER|M26/belinostat|Kendall's Tau|0.127||||0.275|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.275
71074135|NCT01273155|141657378|OTHER|M24/M26|Kendall's Tau|-0.308||||0.002|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.002
71074136|NCT01273155|141657378|OTHER|M26/M21|Kendall's Tau|-0.159||||0.095|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.095
71074137|NCT01273155|141657379|OTHER|Belinostat glucuronide/belinostat|Kendall's Tau|-0.055||||0.568|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.568
71074138|NCT01273155|141657379|OTHER|Methyl belinostat/belinostat|Kendall's Tau|0.38|||<|0.001|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||<0.001
71074139|NCT01273155|141657379|OTHER|M21/belinostat|Kendall's Tau|0.315||||0.001|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.001
71074140|NCT01273155|141657379|OTHER|M24/belinostat|Kendall's Tau|-0.205||||0.037|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.037
71074141|NCT01273155|141657379|OTHER|M26/belinostat|Kendall's Tau|0.218||||0.033|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.033
71074142|NCT01273155|141657379|OTHER|M24/M26|Kendall's Tau|-0.309||||0.001|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.001
71074143|NCT01273155|141657379|OTHER|M26/M21|Kendall's Tau|-0.205||||0.032|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.032
71074144|NCT01256385|141657382|SUPERIORITY_OR_OTHER|||||||0.73|||||||Log Rank|||||||0.73
71074145|NCT01256385|141657383|SUPERIORITY_OR_OTHER|||||||0.87|||||||Log Rank|||||||0.87
71074146|NCT01256385|141657384|SUPERIORITY_OR_OTHER|||||||0.2|||||||Fisher Exact|||||||0.20
71074147|NCT01256385|141657385|SUPERIORITY|||||||0.006|||||||Chi-squared|||PFS at 4 months in Arm A was compared with a 4-month historical control rate of 21.4%, using a one-sided test at the 0.05 significant level. The historical data appear in two publications, an ASCO abstract: Abidoye, ASCO Annual Meeting 2006: 5568, and de Souza, Davis, et al, Clin Cancer Res 2012; 18(8):2336-2343 (see Figure 1).||||0.006
71074148|NCT01256385|141657385|SUPERIORITY|||||||0.037||||||1-sided.|Chi-squared|||PFS at 4 months in Arm B was compared with a 4-month historical control rate of 21.4%, using a one-sided test at the 0.05 significant level. The historical data appear in two publications, an ASCO abstract: Abidoye, ASCO Annual Meeting 2006: 5568, and de Souza, Davis, et al, Clin Cancer Res 2012; 18(8):2336-2343 (see Figure 1).||||0.037
71074149|NCT01256385|141657386|SUPERIORITY_OR_OTHER|||||||0.59|||||||Fisher Exact|||||||0.59
71074150|NCT00725101|141657391|SUPERIORITY_OR_OTHER|||||||0.0074||95.0||||P-value for age over 65.|Regression, Logistic|||||||0.0074
71074151|NCT00725101|141657391|SUPERIORITY_OR_OTHER|||||||0.0028||95.0||||P-value for female physicians.|Regression, Logistic|||||||0.0028
71074152|NCT00725101|141657391|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for Rheumatology versus PCP.|Regression, Logistic|||||||<0.0001
71074153|NCT00725101|141657391|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for other specialty versus PCP.|Regression, Logistic|||||||<0.0001
71074154|NCT00725101|141657391|SUPERIORITY_OR_OTHER|||||||0.0064||95.0||||P-value for use of opioids.|Regression, Logistic|||||||0.0064
71074155|NCT00725101|141657391|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for use of NSAIDs.|Regression, Logistic|||||||<0.0001
71074156|NCT00725101|141657391|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for number of medications participants were taking.|Regression, Logistic|||||||<0.0001
71074157|NCT00725101|141657392|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||P-value for GAD-7 score.|Regression, Logistic|||||||0.026
71074158|NCT00725101|141657392|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value for pregabalin use.|Regression, Logistic|||||||0.021
71074159|NCT00725101|141657392|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value for NSAID use.|Regression, Logistic|||||||0.050
71078812|NCT01796301|141665656|SUPERIORITY||Treatment difference|3.6|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.9|4.2|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||4.2|2.9|< 0.0001
70940414|NCT00141271|141380821|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2048||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.2048
70940415|NCT00141271|141380822|SUPERIORITY_OR_OTHER_LEGACY|||||||0.434||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4340
70940416|NCT00141271|141380822|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7774||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.7774
70940417|NCT00141271|141380823|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5195||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.5195
71074160|NCT02889835|141657422|SUPERIORITY|||||||0.686|||||||Log Rank|||Kaplan-Meier analysis was performed to assess survival over 36 months. Test of survival distributions for the three arms were calculated using Log Rank (Mantel-Cox). Sample size is based on guidelines of the American Dental Association for obtaining approval as an amalgam replacement for posterior restorations - minimum of 40 restorations in a minimum of 20 subjects at 18 months. Sample size is based by taking subject attrition into account over the 36 month clinical evaluation.||||0.686
70940418|NCT00141271|141380823|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0153||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.0153
70940419|NCT00141271|141380824|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2847||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.2847
71074161|NCT02889835|141657423|SUPERIORITY|||||||0.701|||||||Kruskal-Wallis|||||||0.701
71074162|NCT02889835|141657424|SUPERIORITY|||||||0.812|||||||Kruskal-Wallis|||||||0.812
71074163|NCT02889835|141657425|SUPERIORITY|||||||0.104|||||||Kruskal-Wallis|||||||0.104
71074164|NCT02889835|141657426|SUPERIORITY|||||||0.44|||||||Kruskal-Wallis|||||||0.440
71074165|NCT02889835|141657427|SUPERIORITY|||||||0.676|||||||Kruskal-Wallis|||||||0.676
71074166|NCT02889835|141657428|SUPERIORITY|||||||1|||||||Kruskal-Wallis|||||||1.000
71074167|NCT02889835|141657429|SUPERIORITY|||||||0.764|||||||Kruskal-Wallis|||||||0.764
71074168|NCT02889835|141657430|SUPERIORITY|||||||0.323|||||||Kruskal-Wallis|||||||0.323
71074169|NCT02889835|141657431|SUPERIORITY|||||||0.714|||||||Kruskal-Wallis|||||||0.714
71074170|NCT02889835|141657432|SUPERIORITY|||||||0.846|||||||Kruskal-Wallis|||||||0.846
71074171|NCT02889835|141657433|SUPERIORITY|||||||1|||||||Kruskal-Wallis|||||||1.000
71074172|NCT02889835|141657434|SUPERIORITY|||||||0.424|||||||Kruskal-Wallis|||||||0.424
71074173|NCT00577005|141657443|SUPERIORITY_OR_OTHER||Slope|-0.05425|STANDARD_ERROR_OF_MEAN|0.03211||0.09|TWO_SIDED|||||p-value \<0.05 considered statistically significant|Mixed Models Analysis|We modeled the the change in thrice weekly cocaine urines using a mixed-effect ordinal regression approach with MIXOR.|Group x time interaction: Z=-1.68950 p = 0.09112|||||0.09
71074174|NCT00577005|141657444|SUPERIORITY_OR_OTHER||Slope|0.0257|STANDARD_ERROR_OF_MEAN|0.04369||0.55|TWO_SIDED|||||p-value \<0.05 considered statistically significant|Mixed Models Analysis|We modeled the the change in thrice weekly opioid urines using a mixed-effect ordinal regression approach with MIXOR.|Group x time interaction: Z= 0.58823 p = 0.55638|||||0.55
71074175|NCT00577005|141657445|SUPERIORITY_OR_OTHER|||||||0.67||||||p-value \<0.05 considered statistically significant|Log Rank|Chi-Square 0.175. df = 1, p=0.676||||||0.67
71074176|NCT00577005|141657446|SUPERIORITY_OR_OTHER||Slope|-0.1557||||0.11|TWO_SIDED|||||Significant p-value \< 0.05|Mixed Models Analysis||Interaction of time x group: Z = -1.5671, p = 0.11708|||||0.11
71074177|NCT04108988|141657461|SUPERIORITY|||||||0.248|||||||Chi-squared|||P value at 4 months||||0.248
71074178|NCT04108988|141657461|SUPERIORITY|||||||0.022|||||||Chi-squared|||P value at 1 month||||0.022
71074179|NCT04108988|141657461|SUPERIORITY|||||||0.193|||||||Chi-squared|||P value at baseline||||0.193
71074180|NCT04108988|141657462|SUPERIORITY|||||||0.246|||||||Chi-squared|||P value at 4 months||||0.246
71074181|NCT04108988|141657462|SUPERIORITY|||||||0.467|||||||Chi-squared|||P value at 1 month||||0.467
70940420|NCT00141271|141380824|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1958||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1958
71115866|NCT02152371|141738253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-17.18|STANDARD_ERROR_OF_MEAN|4.45|<|0.001|TWO_SIDED|95.0|-25.96|-8.4|||Mixed Models Analysis|||Morning Meal 2-Hour Postprandial||-8.40|-25.96|<.001
71115867|NCT02152371|141738253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-15.55|STANDARD_ERROR_OF_MEAN|4.08|<|0.001|TWO_SIDED|95.0|-23.58|-7.52|||Mixed Models Analysis|||Pre-Midday Meal||-7.52|-23.58|<.001
71115868|NCT02152371|141738253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-18.15|STANDARD_ERROR_OF_MEAN|4.58|<|0.001|TWO_SIDED|95.0|-27.18|-9.12|||Mixed Models Analysis|||Midday Meal 2-Hour Postprandial||-9.12|-27.18|<.001
71115869|NCT02152371|141738253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-14.96|STANDARD_ERROR_OF_MEAN|4.55||0.001|TWO_SIDED|95.0|-23.93|-5.99|||Mixed Models Analysis|||Pre-Evening Meal||-5.99|-23.93|.001
70940421|NCT00141271|141380825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1652||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1652
70940422|NCT00141271|141380825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5997||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.5997
71074182|NCT04108988|141657462|SUPERIORITY|||||||0.55|||||||Chi-squared|||P value at baseline||||0.550
71074183|NCT04108988|141657463|SUPERIORITY|||||||0.596|||||||Chi-squared|||P value at month 4||||0.596
71074184|NCT04108988|141657463|SUPERIORITY|||||||0.974|||||||Chi-squared|||P value at 1 month||||0.974
71074185|NCT04108988|141657463|SUPERIORITY|||||||0.651|||||||Chi-squared|||P value at baseline.||||0.651
71074186|NCT04108988|141657464|SUPERIORITY|||||||0.089|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.089
71074187|NCT04108988|141657465|SUPERIORITY|||||||0.095|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.095
71074188|NCT04108988|141657466|SUPERIORITY|||||||0.136|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.136
71074189|NCT04108988|141657467|SUPERIORITY|||||||0.133|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.133
71074190|NCT04108988|141657468|SUPERIORITY|||||||0.21|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.210
71074191|NCT04108988|141657469|SUPERIORITY|||||||0.392|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.392
71074192|NCT04108988|141657470|SUPERIORITY|||||||0.411|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.411
71074193|NCT04108988|141657471|SUPERIORITY|||||||0.294|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.294
71074194|NCT04108988|141657472|SUPERIORITY|||||||0.031|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.031
71074195|NCT04108988|141657473|SUPERIORITY|||||||0.262|||||||ANOVA|Test for the interaction between treatment and time||Test of interaction with treatment and time.||||0.262
71074196|NCT04108988|141657474|SUPERIORITY|||||||0.116|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.116
71074197|NCT04108988|141657475|SUPERIORITY|||||||0.016|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.016
71074198|NCT04108988|141657476|SUPERIORITY|||||||0.667|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.667
71074199|NCT04108988|141657477|SUPERIORITY|||||||0.09|||||||Chi-squared|||P value at month 4||||0.09
71074200|NCT04108988|141657477|SUPERIORITY|||||||0.72|||||||Chi-squared|||P value 1 month||||0.72
71074201|NCT04108988|141657477|SUPERIORITY|||||||0.97|||||||Chi-squared|||P value at baseline||||0.97
71074202|NCT04108988|141657478|SUPERIORITY|||||||0.53|||||||Chi-squared|||P value at month 4||||0.53
71074203|NCT04108988|141657478|SUPERIORITY|||||||0.303|||||||Chi-squared|||P value at month 1||||0.303
71074204|NCT04108988|141657478|SUPERIORITY|||||||0.042|||||||Chi-squared|||P value at baseline.||||0.042
71074205|NCT04108988|141657479|SUPERIORITY|||||||0.246|||||||Chi-squared|||P value at month 4.||||0.246
71074206|NCT04108988|141657479|SUPERIORITY|||||||0.467|||||||Chi-squared|||P value at month 1.||||0.467
71074207|NCT04108988|141657479|SUPERIORITY|||||||0.55|||||||Chi-squared|||P value at baseline.||||0.55
71074208|NCT04108988|141657480|SUPERIORITY|||||||0.987|||||||Chi-squared|||P value at month 4.||||0.987
71074209|NCT04108988|141657480|SUPERIORITY|||||||0.898|||||||Chi-squared|||P value at month 1.||||0.898
71074210|NCT04108988|141657480|SUPERIORITY|||||||0.238|||||||Chi-squared|||P value at baseline.||||0.238
71074211|NCT04108988|141657481|SUPERIORITY|||||||0.148|||||||Chi-squared|||P value at month 4.||||0.148
71074212|NCT04108988|141657481|SUPERIORITY|||||||0.557|||||||Chi-squared|||P value at month 1.||||0.557
71074213|NCT04108988|141657482|SUPERIORITY|||||||0.653|||||||Chi-squared|||||||0.653
71074214|NCT04108988|141657483|SUPERIORITY|||||||0.977|||||||Chi-squared|||||||0.977
71074215|NCT04108988|141657484|SUPERIORITY|||||||0.735|||||||t-test, 2 sided|||P value at month 4.||||0.735
71074216|NCT04108988|141657484|SUPERIORITY|||||||0.159|||||||t-test, 2 sided|||P value at month 1.||||0.159
71074217|NCT04108988|141657485|SUPERIORITY|||||||3.19|||||||t-test, 2 sided|||P value at month 4.||||3.19
71074218|NCT04108988|141657485|SUPERIORITY|||||||0.487|||||||t-test, 2 sided|||P value at month 1.||||0.487
71074219|NCT04108988|141657485|SUPERIORITY|||||||0.165|||||||t-test, 2 sided|||P value at baseline.||||0.165
71074220|NCT04108988|141657486|SUPERIORITY|||||||0.473|||||||t-test, 2 sided|||P value at month 4.||||0.473
71074221|NCT04108988|141657486|SUPERIORITY|||||||0.316|||||||t-test, 2 sided|||P value at month 1.||||0.316
71074222|NCT04108988|141657486|SUPERIORITY|||||||0.345|||||||t-test, 2 sided|||P value at baseline.||||0.345
71074223|NCT04108988|141657487|SUPERIORITY|||||||0.141|||||||t-test, 2 sided|||P value at month 4.||||0.141
71074224|NCT04108988|141657487|SUPERIORITY|||||||0.314|||||||t-test, 2 sided|||P value at month 1.||||0.314
71074225|NCT04108988|141657487|SUPERIORITY|||||||0.444|||||||t-test, 2 sided|||P value at baseline.||||0.444
71074226|NCT00033657|141657616|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48|TWO_SIDED|95.0|||||Log Rank|||||||0.48
71074227|NCT02945254|141657618|SUPERIORITY|||||||0.011||||||P\<0.05 considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.011
71074228|NCT02945254|141657619|SUPERIORITY|||||||0.13||||||P\<0.05 considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.13
71074229|NCT03436199|141657621|SUPERIORITY||Risk Difference (RD)|0.064||||0.0811|TWO_SIDED|95.0|-0.008|0.136|||Farrington-Manning score test|The Miettinen-Nurminen method was used to obtain the 95% confidence intervals.||||0.136|-0.008|0.0811
71074230|NCT03436199|141657621|SUPERIORITY||Risk Difference (RD)|0.098||||0.0104|TWO_SIDED|95.0|0.023|0.174|||Farrington-Manning score test|The Miettinen-Nurminen method was used to obtain the 95% confidence intervals.||||0.174|0.023|0.0104
71074231|NCT03436199|141657622|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.048||0.0162|TWO_SIDED|95.0|0.02|0.21|||Mixed Models Analysis|Mixed models analysis with repeated measures||||0.21|0.02|0.0162
71074232|NCT03436199|141657622|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0142|TWO_SIDED|95.0|0.02|0.22|||Mixed Models Analysis|Mixed models analysis with repeated measures||||0.22|0.02|0.0142
71074233|NCT03436199|141657623|SUPERIORITY||Mean Difference (Net)|-0.79|STANDARD_ERROR_OF_MEAN|0.538||0.1424|TWO_SIDED|95.0|-1.85|0.27|||Mixed Models Analysis|Mixed models analysis with repeated measures||||0.27|-1.85|0.1424
70940423|NCT00141271|141380826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0082||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.0082
70940424|NCT00141271|141380826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7037||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7037
70940425|NCT00141271|141380827|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2718||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.2718
70940426|NCT00141271|141380827|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7077||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7077
70940427|NCT00141271|141380828|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5057||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.5057
71074234|NCT03436199|141657623|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.56||0.9467|TWO_SIDED|95.0|-1.14|1.06|||Mixed Models Analysis|Mixed models analysis with repeated measures||||1.06|-1.14|0.9467
71115870|NCT02152371|141738253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-21.28|STANDARD_ERROR_OF_MEAN|5.68|<|0.001|TWO_SIDED|95.0|-32.46|-10.1|||Mixed Models Analysis|||Evening Meal 2-Hour Postprandial||-10.10|-32.46|<.001
70940428|NCT00141271|141380828|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3654||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.3654
70940429|NCT00141271|141380829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6227||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.6227
70940430|NCT00141271|141380829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7737||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7737
71074235|NCT03436199|141657624|SUPERIORITY||Mean Difference (Net)|4.143|STANDARD_ERROR_OF_MEAN|1.7389||0.0176|TWO_SIDED|95.0|0.726|7.56|||Mixed Models Analysis|Mixed models analysis with repeated measures||||7.560|0.726|0.0176
71074236|NCT03436199|141657624|SUPERIORITY||Mean Difference (Net)|3.529|STANDARD_ERROR_OF_MEAN|1.8196||0.053|TWO_SIDED|95.0|-0.046|7.104|||Mixed Models Analysis|Mixed models analysis with repeated measures||||7.104|-0.046|0.0530
71074237|NCT01886781|141657641|NON_INFERIORITY_OR_EQUIVALENCE|To determine an effect size of 0.64 with 80% power, a sample size of 27 for each group (D-IBS, C-IBS and controls), with a type 1 error of 5% using a two sided test was sufficient. Sample size based on expected behaviour of primary outcome measure. The minimally clinically important difference based on the primary outcome measure with the instrument used was 50 points.|||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||An intention-to -treat (ITT) analysis was performed on all patients who underwent randomization (n = 81). The results of the ITT analysis are presented. Changes in Severity Score was examined using the mixed model for analysis of variance to account for missing data. This model used group (treatment vs control) \& time as factors.||||<0.05
71074238|NCT01832818|141657661|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71074239|NCT01832818|141657662|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||< 0.05
71074240|NCT01672294|141657667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5376|||<|0.511|TWO_SIDED|95.0|-1.0776|2.1528||Between Outlook Intervention and Attention Control caregivers at 5 weeks|Mixed Models Analysis|||Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.||2.1528|-1.0776|<0.511
71074241|NCT01672294|141657667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4275||||0.6348|TWO_SIDED|95.0|-1.3505|2.2055||Between Outlook Intervention and Attention Control caregivers at 8 weeks|Mixed Models Analysis|||Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.||2.2055|-1.3505|0.6348
71074242|NCT01672294|141657668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6836||||0.5225|TWO_SIDED|95.0|-1.4278|2.795|||Mixed Models Analysis|||Comparison at 5 weeks Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.||2.7950|-1.4278|0.5225
71074243|NCT01672294|141657668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2764||||0.1972|TWO_SIDED|95.0|-0.6728|3.2257|||Mixed Models Analysis|||Comparison at 8 weeks. Note-missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.||3.2257|-0.6728|0.1972
71115871|NCT02152371|141738253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-19.48|STANDARD_ERROR_OF_MEAN|4.72|<|0.001|TWO_SIDED|95.0|-28.77|-10.18|||Mixed Models Analysis|||3:00AM (Morning)||-10.18|-28.77|<.001
71115872|NCT02152371|141738254|SUPERIORITY_OR_OTHER_LEGACY||LS Means Difference|-2.41|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-3.19|-1.64|||Mixed Models Analysis|||||-1.64|-3.19|<.001
71115873|NCT02152371|141738255|SUPERIORITY_OR_OTHER_LEGACY||LS Means Diff|-13.19|STANDARD_ERROR_OF_MEAN|3.21|<|0.001|TWO_SIDED|95.0|-19.55|-6.84|||MMRM|||||-6.84|-19.55|<.001
70940431|NCT01636778|141380875|SUPERIORITY_OR_OTHER||Percentage|88.0|||||TWO_SIDED|95.0|74.0|96.0||||||||96|74|
70940432|NCT01154699|141380933|SUPERIORITY_OR_OTHER|||||||0.8|||||||t-test, 2 sided|||The difference in the change in asthma control during the Usual care and the Bilevel PAP period were compared.||||0.8
70940433|NCT01154699|141380934|SUPERIORITY_OR_OTHER|||||||0.2|||||||t-test, 2 sided|||Change in PC20 between the two arms||||0.20
70940434|NCT01154699|141380935|SUPERIORITY_OR_OTHER|||||||0.78|||||||t-test, 2 sided|||||||0.78
70940435|NCT01154699|141380936|SUPERIORITY_OR_OTHER|||||||0.61|||||||t-test, 2 sided|||||||0.61
70940436|NCT01154699|141380937|SUPERIORITY_OR_OTHER|||||||0.94|||||||t-test, 2 sided|||||||0.94
70940437|NCT01154699|141380938|SUPERIORITY_OR_OTHER|||||||0.76|||||||t-test, 2 sided|||||||0.76
71074244|NCT01672294|141657669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9358|||<|0.3332|TWO_SIDED|95.0|-0.9726|2.8443|||Mixed Models Analysis|||Between Outlook Intervention caregivers and active control caregivers at 5 weeks Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.||2.8443|-0.9726|<0.3332
71074245|NCT01672294|141657669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6929||||0.3842|TWO_SIDED|95.0|-0.8783|2.2642||Note-missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks|Mixed Models Analysis|||Between Outlook Intervention caregivers and active control caregivers at 8 weeks Note - Missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks||2.2642|-0.8783|0.3842
71074246|NCT01672294|141657670|SUPERIORITY_OR_OTHER||expected change in difference in logs|0.0593||||0.8748|TWO_SIDED|95.0|-0.6784|0.797|||Standard negative binomial with offset||The expected change in the difference of the logs of expected Days in VA inpatient care or ED.|||0.797|-0.6784|0.8748
71074247|NCT01672294|141657671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01777||||0.7687|TWO_SIDED|95.0|-0.1372|0.1017||Between Caregiver Outlook - Caregiver and Relaxation Meditation - Caregiver at 5 weeks|Mixed Models Analysis|||"Between Outlook Intervention caregivers and active control caregivers at 5 weeks.~Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks."||0.1017|-0.1372|0.7687
71074248|NCT01672294|141657671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.00087||||0.9863|TWO_SIDED|95.0|-0.1003|0.09861||Between Caregiver Outlook - Caregiver and Relaxation Meditation - Caregiver at 8 weeks|Mixed Models Analysis|||Between Outlook Intervention caregivers and active control caregivers at 8 weeks Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.||0.09861|-0.1003|0.9863
71074249|NCT01672294|141657672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01166||||0.9221|TWO_SIDED|95.0|-0.2475|0.2241|||Mixed Models Analysis|||At 5 weeks - Completion subscale||0.2241|-0.2475|0.9221
71074250|NCT01672294|141657672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1154||||0.3249|TWO_SIDED|95.0|-0.3466|0.1158||Between Caregiver Outlook - Caregiver and Relaxation Meditation - Caregiver at 8 weeks|Mixed Models Analysis|||Comparison at 8 week time point Note- Missing first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 week.||0.1158|-0.3466|0.3249
71074251|NCT00336323|141657675|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness at the 3 week visit between the laser only treatment group to the 1.25 mg injection at baseline and at 6 weeks treatment group||||0.009
71074252|NCT00336323|141657675|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness at the 3 week visit between the laser only treatment group to the 2.5mg injection at baseline and 6 weeks treatment group||||<0.001
71074253|NCT00336323|141657675|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||Adjusted for baseline values|Least squares regression|||Comparison of the reduction in central subfield thickening in the 1.25mg injection at baseline and at 6 weeks treatment group with the 2.5mg injection at baseline and 6 weeks treatment group at the 3 week visit||||0.66
71074254|NCT00336323|141657675|SUPERIORITY_OR_OTHER|||||||0.49||95.0||||Adjusted for baseline values|Least squares regression|||Comparison of the reduction in central subfield thickening in the 1.25mg injection at baseline and at 6 weeks treatment group with the 2.5mg injection at baseline and 6 weeks treatment group at the 6 week visit||||0.49
71074255|NCT00336323|141657675|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||Adjusted for baseline values|Least squares regression|||Comparison of the reduction in central subfield thickening in the 1.25mg injection at baseline and at 6 weeks treatment group with the 2.5mg injection at baseline and 6 weeks treatment group at the 9 week visit||||0.45
71074256|NCT00336323|141657675|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of the reduction in central subfield thickening in the 1.25mg injection at baseline and at 6 weeks treatment group with the 2.5mg injection at baseline and 6 weeks treatment group at the 12 week visit||||0.90
71074257|NCT00336323|141657676|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of improvement in visual acuity between the 1.25mg injection at baseline and at 6 weeks treatment group and the 2.5mg injection at baseline and 6 weeks treatment group at the 3 week visit||||0.42
71074258|NCT00336323|141657676|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of improvement in visual acuity between the 1.25mg injection at baseline and at 6 weeks treatment group and the 2.5mg injection at baseline and 6 weeks treatment group at the 6 week visit||||0.67
71115874|NCT02152371|141738262|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.66|||<|0.001|TWO_SIDED|95.0|3.7|12.0|||Regression, Logistic|||||12.00|3.70|<.001
71074259|NCT00336323|141657676|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of improvement in visual acuity between the 1.25mg injection at baseline and at 6 weeks treatment group and the 2.5mg injection at baseline and 6 weeks treatment group at the 9 week visit||||0.48
71074260|NCT00336323|141657676|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||Least squares regression|||Comparison of improvement in visual acuity between the 1.25mg injection at baseline and at 6 weeks treatment group and the 2.5mg injection at baseline and 6 weeks treatment group at the 12 week visit||||0.82
70853494|NCT01375075|141195100|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.13||0.181|TWO_SIDED|90.0|-0.04|0.4|||ANCOVA|Treatment was included in the model as fixed effects, baseline hsCRP as covariate.||||0.40|-0.04|0.181
71115875|NCT02152371|141738262|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio, log|5.71|||<|0.001|TWO_SIDED|95.0|3.35|9.73|||Regression, Logistic|||||9.73|3.35|<.001
71115876|NCT02152371|141738263|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.17|||<|0.001|TWO_SIDED|95.0|2.32|7.47|||Regression, Logistic|||||7.47|2.32|<.001
71115877|NCT02152371|141738264|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.61|||<|0.001|TWO_SIDED|95.0|2.09|6.23|||Regression, Logistic|||||6.23|2.09|<.001
71115878|NCT02152371|141738265|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.6|||<|0.001|TWO_SIDED|95.0|3.26|9.62|||Regression, Logistic|||||9.62|3.26|<.001
71115879|NCT04382586|141738269|SUPERIORITY||Odds Ratio (OR)|1.61||||0.4099|TWO_SIDED|95.0|0.349|7.391|||Unstratified 1-sided Fisher's exact test|||||7.391|0.349|0.4099
71115880|NCT04382586|141738270|SUPERIORITY||Hazard Ratio (HR)|0.918||||0.7619|TWO_SIDED|95.0|0.511|1.648|||Log Rank|||||1.648|0.511|0.7619
71074261|NCT00336323|141657676|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of improvement in visual acuity through the 12 week visit between the laser only treatment group and the 1.25mg injection at baseline and at 6 weeks treatment group||||0.01
71074262|NCT00336323|141657676|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of improvement in visual acuity through the 12 week visit between the laser only treatment group and the 2.5mg injection at baseline and at 6 weeks treatment group||||0.003
71074263|NCT00336323|141657679|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had baseline central subfield thickness of \<400 microns compared to those that had baseline central subfield thickness of ≥400 microns. Eyes included all of those from the pooled Bevacizumab group.||||<0.0001
71074264|NCT00336323|141657680|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Least squares regression|Adjusted for baseline score||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had baseline visual acuity letter score that was \<65 letters compared to those that had baseline visual acuity letter score that was ≥65 letters. Eyes included all of those from the pooled Bevacizumab group.||||0.31
71115881|NCT04113018|141738331|SUPERIORITY||Response rate|0.5385||||0.375|TWO_SIDED|95.0|0.3718|0.6991|||Fisher Exact||Confidence interval estimated using the Clopper Pearson method.|A minimax 2-stage design was used to test the hypothesis that the CR+ rate less than or equal to 50%. Twenty-three evaluable subjects were enrolled in the first stage, followed by an additional 16 subjects for a total of 39 subjects. This design provided 90% power to detect a difference of 20% under the alternative hypothesis, assuming a one-sided alpha=0.10 significance level. If at least 24 of 39 participants had achieved CR or better to induction, the null hypothesis would have been rejected.||0.6991|0.3718|0.375
71115882|NCT04113018|141738338|OTHER|Estimation only|Rate|0.0513|||||TWO_SIDED|95.0|0.0063|0.1732|||||Confidence interval estimated using the Clopper Pearson method.|||0.1732|0.0063|
71115883|NCT04113018|141738339|OTHER|Estimation only.|Rate|0.0256|||||TWO_SIDED|95.0|0.0006|0.1348|||||Confidence interval estimated using the Clopper Pearson method.|||0.1348|0.0006|
71115884|NCT02791516|141738358|SUPERIORITY||LS Mean Difference|9.6|STANDARD_ERROR_OF_MEAN|1.0|<|0.001|TWO_SIDED|95.0|7.6|11.5|||ANCOVA|ANCOVA model adjusting for treatment, baseline DXA BMD value, machine type, and machine type-by-baseline DXA BMD value.||||11.5|7.6|<0.001
71115885|NCT02791516|141738359|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|1.4|3.7|||ANCOVA|ANCOVA model adjusting for treatment, baseline DXA BMD value, machine type, and machine type-by-baseline DXA BMD value.||||3.7|1.4|<0.001
71115886|NCT02791516|141738360|SUPERIORITY||LS Mean Difference|2.2|STANDARD_ERROR_OF_MEAN|0.7||0.004|TWO_SIDED|95.0|0.7|3.6|||ANCOVA|ANCOVA model adjusting for treatment, baseline DXA BMD value, machine type, and machine type-by-baseline DXA BMD value.||||3.6|0.7|0.004
71074265|NCT00336323|141657681|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||Least squares regression|||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between those that were ≤66 years old compared to those that were \>66 years old at baseline. Eyes included all of those from the pooled Bevacizumab group.||||0.44
71115887|NCT03479541|141738361|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.097||||0.013|TWO_SIDED|95.0|-0.173|-0.02||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||-0.020|-0.173|0.013
71074266|NCT00336323|141657682|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Least squares regression|||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between females and males. Eyes included all of those from the pooled Bevacizumab group.||||0.55
71115888|NCT03479541|141738362|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.073||||0.013|TWO_SIDED|95.0|-0.13|-0.016||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||-0.016|-0.130|0.013
71115889|NCT03479541|141738363|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.098||||0.01|TWO_SIDED|95.0|0.024|0.173||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.173|0.024|0.010
71115890|NCT03479541|141738364|OTHER|||||||0.5158|||||||Wilcoxon (Mann-Whitney)|||||||0.5158
70940438|NCT03530345|141380947|SUPERIORITY||Mean Difference (Net)|-1.07|STANDARD_ERROR_OF_MEAN|0.404||0.0111|TWO_SIDED|95.0|-1.89|-0.26||2-sided p-value for testing superiority of neridronic acid 400 mg compared to placebo.|Mixed Models Analysis|The degrees of freedom of the denominator are estimated using the Kenward-Roger approximation.|The primary endpoint estimate was the least squares mean differences of change from baseline in pain NRS (electronic diary) at Week 12 between neridronate and Placebo.|Mixed-effects model for repeated measures (MMRM) defined with baseline pain intensity as covariate, the factors geographic region, week, treatment and treatment-by-week as fixed effects, and an unstructured covariance matrix to model the covariance structure of the repeated measurements.||-0.26|-1.89|0.0111
71074267|NCT00336323|141657683|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had no history of treatment for diabetic macular edema compared to those that had history or treatment for diabetic macular edema. Eyes included all of those from the pooled Bevacizumab group.||||0.16
71115891|NCT03479541|141738365|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.0404||||0.45|TWO_SIDED|95.0|-0.0648|0.146||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.146|-0.0648|0.450
71115892|NCT03479541|141738366|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time point (pre-physical therapy and post-physical therapy), and group x time point injury interaction with random intercepts, covariates (age, gender, Initial SCAT symptom severity total score, and days since injury before physical therapy), and inverse probability weights. Later Physical Therapy Group and pre-physical therapy time point served as the reference. Values were log-transformed for model assumptions.|Slope|0.05353||||0.6039|TWO_SIDED|95.0|-0.1503|0.2574||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change from pre-physical therapy to post-physical therapy time points (the interaction effect of the mixed model analysis).|Analysis for Horizontal DVA Lines Lost||0.2574|-0.1503|0.6039
71117706|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-7.36||||0.126|TWO_SIDED|95.0|-16.63|1.9||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.90|-16.63|0.126
70853495|NCT01375075|141195101|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.29|STANDARD_ERROR_OF_MEAN|5.97|<|0.001|TWO_SIDED|90.0|-53.16|-33.41||The P-value is for percent change from baseline in plasma CETP activity at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-33.41|-53.16|<0.001
71074268|NCT00336323|141657684|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Least squares regression|||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had baseline retinopathy severity that was \<severe nonproliferative diabetic retinopathy (NPDR) compared to those that had baseline retinopathy severity that was proliferative diabetic retinopathy or severe NPDR. Eyes included all of those from the pooled Bevacizumab group.||||0.53
71074269|NCT00336323|141657685|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had baseline clinical diabetic macular edema characterized as typical/predominantly focal, neither predominantly focal or diffuse, or typical/predominantly diffuse. Eyes included all of those from the pooled Bevacizumab group.||||0.93
71074270|NCT00336323|141657686|SUPERIORITY_OR_OTHER|||||||0.52||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had baseline subretinal fluid that was definite/questionable compared to eyes that had no evidence of subretinal fluid at baseline. Eyes included all of those from the pooled Bevacizumab group.||||0.52
70940439|NCT04853394|141380963|SUPERIORITY||Risk Ratio (RR)|0.33|||<|0.01|TWO_SIDED|95.0|0.21|0.51|||Mixed Models Analysis|Mixed effects modified Poisson regression model with random intercepts for participant and network cluster|Effect of MASLIHAT vs. comparison TANSIHAT condition at 12-month follow-up|||.51|.21|<.01
70940440|NCT04853394|141380964|SUPERIORITY||Risk Ratio (RR)|0.67||||0.01|TWO_SIDED|95.0|0.46|0.97|||Mixed Models Analysis|Mixed effects modified Poisson regression model with random intercepts for participant and network cluster|Effect of MASLIHAT vs. comparison TANSIHAT condition at 12-month follow-up|||.97|.46|.01
70940441|NCT04853394|141380965|SUPERIORITY||Risk Ratio (RR)|0.86||||0.01|TWO_SIDED|95.0|0.77|0.95|||Mixed Models Analysis|Mixed effects Poisson regression model with random intercepts for participant and network cluster|Effect of MASLIHAT vs. comparison TANSIHAT condition at 6-month follow-up|||.95|.77|.01
71074271|NCT00336323|141657687|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that had baseline central subfield thickness of \<400 microns compared to eyes that had baseline central subfield thickness of ≥400 microns. Eyes included all of those from the pooled Bevacizumab group.||||0.22
71074272|NCT00336323|141657688|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that had a baseline visual acuity letter score of \<65 letters compared to eyes that had baseline visual acuity letter score of ≥65 letters. Eyes included all of those from the pooled Bevacizumab group.||||0.006
71074273|NCT00336323|141657689|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that were ≤66 years old at baseline compared to eyes that were \>66 years old at baseline. Eyes included all of those from the pooled Bevacizumab group.||||0.23
71074274|NCT00336323|141657690|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between females and males. Eyes included all of those from the pooled Bevacizumab group.||||0.37
71074275|NCT00336323|141657691|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that did not have a prior history of treatment for diabetic macular edema compared to eyes that did have a prior history of treatment for diabetic macular edema. Eyes included all of those from the pooled Bevacizumab group.||||0.04
71074276|NCT00336323|141657692|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that had a baseline retinopathy severity of \<severe nonproliferative diabetic retinopathy (NPDR) compared to eyes that had baseline retinopathy severity of proliferative diabetic retinopathy or severe NPDR. Eyes included all of those from the pooled Bevacizumab group.||||0.38
71074277|NCT00336323|141657693|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that had a baseline clinical diabetic macular edema (DME) characterization of typical/predominantly focal compared to neither predominantly focal or diffuse characterization at baseline and compared to typical/predominantly diffuse characterization at baseline. Eyes included all of those from the pooled Bevacizumab group.||||0.45
71074278|NCT00336323|141657694|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that had a baseline subretinal fluid presence that was definite/questionable compared to eyes that there was no evidence of subretinal fluid at baseline. Eyes included all of those from the pooled Bevacizumab group.||||0.06
70940442|NCT04853394|141380965|SUPERIORITY||Risk Ratio (RR)|1.19||||0.01|TWO_SIDED|95.0|0.98|1.45|||Mixed Models Analysis|Mixed effects Poisson regression model with random intercepts for participant and network cluster|Effect of MASLIHAT vs. comparison TANSIHAT condition at 12-month follow-up|||1.45|.98|.01
70940443|NCT04853394|141380968|SUPERIORITY||Risk Ratio (RR)|0.12||||0.01|TWO_SIDED|95.0|0.07|0.19|||Mixed Models Analysis|Mixed effects Poisson regression model with random intercepts for participant and network cluster|Effect of MASLIHAT vs. comparison TANSIHAT condition at 12-month follow-up|||.19|.07|.01
71074279|NCT01438814|141657707|NON_INFERIORITY_OR_EQUIVALENCE|One-sided test relative to 0.35|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.13|0.12|||ANCOVA|||||0.12|-0.13|<0.0001
71074280|NCT01438814|141657707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.8924||95.0|-0.13|0.12|||ANCOVA|||||0.12|-0.13|0.8924
71074281|NCT01438814|141657708|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8201||95.0|0.672|1.37|||Regression, Logistic|Model includes treatment and continuous baseline HbA1c||||1.370|0.672|0.8201
71074282|NCT01438814|141657709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.022||||0.9397|TWO_SIDED|95.0|0.582|1.796|||Regression, Logistic|Model includes treatment and baseline HbA1c.||||1.796|0.582|0.9397
71074283|NCT01438814|141657710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|2.1||0.3352||95.0|-2.1|6.1|||ANCOVA|||||6.1|-2.1|0.3352
71074284|NCT01438814|141657711|SUPERIORITY_OR_OTHER|||||||0.0308|||||||Fisher Exact|Fishers exact p-value presented due to small cell counts||||||0.0308
71074285|NCT01438814|141657712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.3||0.0545||95.0|0.0|1.0|||ANCOVA|||||1.0|-0.0|0.0545
71074286|NCT01438814|141657713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.997||||0.9886||95.0|0.689|1.445|||Regression, Logistic|||||1.445|0.689|0.9886
71074287|NCT01438814|141657714|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.797||||0.2108||95.0|0.558|1.137|||Regression, Logistic|||||1.137|0.558|0.2108
71074288|NCT01438814|141657715|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.999||||0.9972||95.0|0.712|1.402|||Regression, Logistic|||||1.402|0.712|0.9972
71074289|NCT01438814|141657716|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.832||||0.2816||95.0|0.594|1.163|||Regression, Logistic|||||1.163|0.594|0.2816
71115893|NCT03479541|141738366|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time point (pre-physical therapy and post-physical therapy), and group x time point injury interaction with random intercepts, covariates (age, gender, Initial SCAT symptom severity total score, and days since injury before physical therapy), and inverse probability weights. Later Physical Therapy Group and pre-physical therapy time point served as the references. Values were log-transformed for model assumptions.|Slope|-0.235||||0.0414|TWO_SIDED|95.0|-0.461|-0.0093||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change from pre-physical therapy to post-physical therapy time points (the interaction effect of the mixed model analysis).|Analysis for Vertical DVA Lines Lost||-0.0093|-0.461|0.0414
71115894|NCT03479541|141738367|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.028||||0.387|TWO_SIDED|95.0|-0.09|0.035||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.035|-0.090|0.387
71115895|NCT03479541|141738368|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.008||||0.135|TWO_SIDED|95.0|-0.003|0.019||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.019|-0.003|0.135
71115896|NCT03479541|141738369|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0107||||0.406|TWO_SIDED|95.0|-0.036|0.0146||a priori threshold p \< 0.05|Mixed Models Analysis||||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|0.0146|-0.0360|0.406
71115897|NCT03479541|141738370|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.00391||||0.083|TWO_SIDED|95.0|-0.00052|0.00835||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.00835|-0.00052|0.083
71115898|NCT03479541|141738371|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.003||||0.24|TWO_SIDED|95.0|-0.007|0.002||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for EcFi condition||0.002|-0.007|0.240
71115899|NCT03479541|141738371|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.005||||0.003|TWO_SIDED|95.0|-0.009|-0.002||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for EcFo condition||-0.002|-0.009|0.003
71074290|NCT01438814|141657717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|0.19||0.0011||95.0|0.25|0.98|||ANCOVA|||||0.98|0.25|0.0011
71074291|NCT01438814|141657718|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.951||||0.7682||95.0|0.681|1.328|||Regression, Logistic|||||1.328|0.681|0.7682
71074292|NCT00337779|141657736|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0732|STANDARD_ERROR_OF_MEAN|0.1013||0.4859|TWO_SIDED|95.0|0.8799|1.309|||Regression, Poisson||980 subjects randomized into two arms provide approximately 90% power to detect significant difference between groups of 30% or more in rate of confirmed relapses.|||1.3090|0.8799|0.4859
71074293|NCT01162122|141657739|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H1N1 strain)|1.12|||||TWO_SIDED|95.0|1.0|1.24||||||||1.24|1|
71074294|NCT01162122|141657739|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H1N1 strain)|1.05|||||TWO_SIDED|95.0|0.95|1.17||||||||1.17|0.95|
71074295|NCT01162122|141657739|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H1N1 strain)|0.94|||||TWO_SIDED|95.0|0.85|1.05||||||||1.05|0.85|
71074296|NCT01162122|141657739|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H3N2 strain)|1.01|||||TWO_SIDED|95.0|0.92|1.11||||||||1.11|0.92|
71074297|NCT01162122|141657739|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H3N2 strain)|0.99|||||TWO_SIDED|95.0|0.9|1.08||||||||1.08|0.9|
70940444|NCT01044901|141381021|OTHER|||||||0.0039||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.0039
70940445|NCT01044901|141381022|OTHER||||||<|0.0001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Wilcoxon (Mann-Whitney)|||Primary outcome was presented at baseline as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon (Mann-Whitney test).||||<0.0001
71074298|NCT01162122|141657739|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H3N2 strain)|0.98|||||TWO_SIDED|95.0|0.89|1.07||||||||1.07|0.89|
71115900|NCT03479541|141738372|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0112||||0.042|TWO_SIDED|95.0|-0.0219|-0.0004||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Single Task Average Lap Time||-0.0004|-0.0219|0.042
71115901|NCT03479541|141738372|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0111||||0.0311|TWO_SIDED|95.0|-0.0211|-0.001||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Auditory Stroop Average Lap Time||-0.0010|-0.0211|0.0311
71115902|NCT03479541|141738373|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.00029||||0.3226|TWO_SIDED|95.0|-0.0003|0.00087||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Single Task Gait Speed||0.00087|-0.0003|0.3226
71115903|NCT03479541|141738373|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.00035||||0.2218|TWO_SIDED|95.0|-0.0002|0.0009||a priori threshold p \< 0.05|Mixed Models Analysis|||Analysis for Auditory Stroop Gait Speed|The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|0.00090|-0.0002|0.2218
70940446|NCT01044901|141381023|OTHER|||||||0.0137|||||||t-test, 2 sided|P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.0137
70940447|NCT01044901|141381024|OTHER|||||||0.0039||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.0039
71074299|NCT01162122|141657739|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (B strain)|1.0|||||TWO_SIDED|95.0|0.91|1.1||||||||1.1|0.91|
71074300|NCT01162122|141657739|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (B strain)|0.96|||||TWO_SIDED|95.0|0.87|1.05||||||||1.05|0.87|
70940448|NCT01044901|141381025|OTHER|||||||0.16||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.16
70940449|NCT01044901|141381026|OTHER|||||||0.0039||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.0039
71074301|NCT01162122|141657739|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (B strain)|0.96|||||TWO_SIDED|95.0|0.87|1.05||||||||1.05|0.87|
71074302|NCT01162122|141657740|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was \>0.67.|GMT ratio (H1N1 strain)|1.4|||||TWO_SIDED|95.0|1.32|1.49||||||||1.49|1.32|
71074303|NCT01162122|141657740|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was \>0.67.|GMT ratio (H3N2 strain)|1.61|||||TWO_SIDED|95.0|1.52|1.7||||||||1.7|1.52|
71115904|NCT03479541|141738374|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.161||||0.0742|TWO_SIDED|95.0|-0.0159|0.338||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Single Task 180 Degree Turn Velocity||0.338|-0.0159|0.0742
71115905|NCT03479541|141738374|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.217||||0.0121|TWO_SIDED|95.0|0.048|0.385||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Auditory Stroop 180 Degree Turn Velocity||0.385|0.0480|0.0121
71115906|NCT03479541|141738375|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.00063||||0.8906|TWO_SIDED|95.0|-0.0084|0.00961||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Single Task Percentage of Double Support Time of Gait Cycle||0.00961|-0.0084|0.8906
71115907|NCT03479541|141738375|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.001||||0.8447|TWO_SIDED|95.0|-0.0107|0.00874||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Auditory Stroop Percentage of Double Support Time of Gait Cycle||0.00874|-0.0107|0.8447
71115908|NCT03479541|141738376|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0003||||0.013|TWO_SIDED|95.0|-0.0005|-0.0001||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Visual Weight (VS/EO)||-0.0001|-0.0005|0.013
71115909|NCT03479541|141738376|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.0001||||0.78|TWO_SIDED|95.0|-0.0003|0.0004||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Vestibular Weight (SS+VS/EO)||0.0004|-0.0003|0.780
71115910|NCT03479541|141738377|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.235|||<|0.001|TWO_SIDED|95.0|-0.361|-0.11||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Time Delay (VS/EO)||-0.110|-0.361|<0.001
71117707|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-75.64|||<|0.001|TWO_SIDED|95.0|-90.35|-60.93||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-60.93|-90.35|<0.001
71074304|NCT01162122|141657740|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was \>0.67.|GMT ratio (B strain)|1.15|||||TWO_SIDED|95.0|1.08|1.21||||||||1.21|1.08|
70940450|NCT01044901|141381027|OTHER|||||||0.0011||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Wilcoxon (Mann-Whitney)|||Primary outcome was presented at baseline as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon (Mann-Whitney) test.||||0.0011
71074305|NCT01162122|141657741|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.|Group difference (H1N1 strain)|9.2|||||TWO_SIDED|95.0|7.1|11.3||||||||11.3|7.1|
71074306|NCT01162122|141657741|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.|Group difference (H3N2 strain)|12.7|||||TWO_SIDED|95.0|10.5|14.9||||||||14.9|10.5|
71074307|NCT01162122|141657741|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.|Group difference (B strain)|5.2|||||TWO_SIDED|95.0|3.0|7.4||||||||7.4|3.0|
71115911|NCT03479541|141738377|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.142||||0.002|TWO_SIDED|95.0|-0.233|-0.052||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Time Delay (SS+VS/EO)||-0.052|-0.233|0.002
70940451|NCT01044901|141381028|OTHER|||||||0.1||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Wilcoxon (Mann-Whitney)|||Primary outcome was presented at baseline as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon (Mann-Whitney) test.||||0.10
71115912|NCT03479541|141738378|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.0003||||0.237|TWO_SIDED|95.0|-0.0002|0.0007||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Normalized Stiffness (VS/EO)||0.0007|-0.0002|0.237
71115913|NCT03479541|141738378|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.0008||||0.002|TWO_SIDED|95.0|0.0003|0.001||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Normalized Stiffness (SS+VS/EO)||0.001|0.0003|0.002
70940452|NCT01044901|141381029|OTHER|||||||0.48||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.48
71074308|NCT01162122|141657742|SUPERIORITY_OR_OTHER||GMT ratio (H1N1 strain)|1.37|||||TWO_SIDED|95.0|1.29|1.46||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||1.46|1.29|
71074309|NCT01162122|141657742|SUPERIORITY_OR_OTHER||GMT ratio (H3N2 strain)|1.6|||||TWO_SIDED|95.0|1.51|1.68||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||1.68|1.51|
71074310|NCT01162122|141657742|SUPERIORITY_OR_OTHER||GMT ratio (B strain)|1.14|||||TWO_SIDED|95.0|1.08|1.2||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||1.2|1.08|
71074311|NCT01162122|141657743|SUPERIORITY_OR_OTHER||Group difference (H1N1 strain)|8.9|||||TWO_SIDED|95.0|6.9|10.9||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was \>10%.||10.9|6.9|
71074312|NCT01162122|141657743|SUPERIORITY_OR_OTHER||Group difference (H3N2 strain)|12.7|||||TWO_SIDED|95.0|10.6|14.8||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was \>10%.||14.8|10.6|
71074313|NCT01162122|141657743|SUPERIORITY_OR_OTHER||Group difference (B strain)|5.1|||||TWO_SIDED|95.0|2.9|7.2||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was \>10%.||7.2|2.9|
71074314|NCT01162122|141657747|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was \>0.67.|GMT ratio (H1N1 strain)|1.38|||||TWO_SIDED|95.0|1.25|1.52||||||||1.52|1.25|
71074315|NCT01162122|141657747|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was \>0.67.|GMT ratio (H3N2 strain)|1.57|||||TWO_SIDED|95.0|1.44|1.72||||||||1.72|1.44|
71074316|NCT01162122|141657747|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was \>0.67.|GMT ratio (B strain)|1.12|||||TWO_SIDED|95.0|1.03|1.21||||||||1.21|1.03|
70940453|NCT01044901|141381030|OTHER|||||||0.08||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Fisher Exact|||Primary outcome was presented as frequencies and percentages, and then analyzed with a Fisher exact test.||||0.08
71074317|NCT01162122|141657748|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%|Group difference (H1N1 strain)|11.1|||||TWO_SIDED|95.0|7.5|14.6||||||||14.6|7.5|
71074318|NCT01162122|141657748|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%|Group difference (H3N2 strain)|13.5|||||TWO_SIDED|95.0|9.8|17.2||||||||17.2|9.8|
71074319|NCT01162122|141657748|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%|Group difference (B strain)|5.0|||||TWO_SIDED|95.0|1.4|8.5||||||||8.5|1.4|
71074320|NCT01162122|141657749|SUPERIORITY_OR_OTHER||GMT ratio (H1N1 strain)|1.32|||||TWO_SIDED|95.0|1.2|1.45||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||1.45|1.2|
70940454|NCT01044901|141381031|OTHER|||||||0.91||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.91
70940455|NCT01044901|141381032|OTHER|||||||0.0038||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Wilcoxon (Mann-Whitney)|||Primary outcome was presented at baseline as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon (Mann-Whitney) test.||||0.0038
70940456|NCT01044901|141381033|OTHER|||||||0.034||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.034
70940457|NCT01044901|141381034|OTHER|||||||0.25||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Fisher Exact|||Primary outcome was presented was as frequencies and percentages, and then analyzed with a Fisher exact test.||||0.25
70940458|NCT01044901|141381035|OTHER|||||||0.0288||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Wilcoxon (Mann-Whitney)|||Primary outcome was presented at baseline as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon (Mann-Whitney) test.||||0.0288
71074321|NCT01162122|141657749|SUPERIORITY_OR_OTHER||GMT ratio (H3N2 strain)|1.54|||||TWO_SIDED|95.0|1.42|1.68||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||1.68|1.42|
71074322|NCT01162122|141657749|SUPERIORITY_OR_OTHER||GMT ratio (B strain)|1.11|||||TWO_SIDED|95.0|1.03|1.21||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||1.21|1.03|
71074323|NCT01162122|141657753|SUPERIORITY_OR_OTHER||Group difference (H1N1 strain)|9.9|||||TWO_SIDED|95.0|6.4|13.3||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was \>10%.||13.3|6.4|
71074324|NCT01162122|141657753|SUPERIORITY_OR_OTHER||Group difference (H3N2 strain)|13.0|||||TWO_SIDED|95.0|9.5|16.6||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was \>10%.||16.6|9.5|
71074325|NCT01162122|141657753|SUPERIORITY_OR_OTHER||Group difference (B strain)|4.9|||||TWO_SIDED|95.0|1.5|8.3||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was \>10%.||8.3|1.5|
71074326|NCT01162122|141657754|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was \>0.67.|GMT Ratio (H3N2/Brisbane-overall)|1.45|||||TWO_SIDED|95.0|1.29|1.63||||||||1.63|1.29|
71074327|NCT01162122|141657754|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was \>0.67.|GMT Ratio (H3N2/Wisconsin-overall)|1.36|||||TWO_SIDED|95.0|1.23|1.5||||||||1.5|1.23|
71074328|NCT01162122|141657754|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was ≥0.67.|GMT Ratio (B strain-overall)|1.09|||||TWO_SIDED|95.0|0.98|1.21||||||||1.21|0.98|
71074329|NCT01162122|141657754|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was \>0.67.|GMT Ratio(H3N2/Brisbane-high risk group)|1.35||||||95.0|1.13|1.61||||||||1.61|1.13|
71074330|NCT01162122|141657754|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was \>0.67.|GMT Ratio(H3N2/Wisconsin-high risk group|1.29|||||TWO_SIDED|95.0|1.1|1.5||||||||1.5|1.1|
71074331|NCT01162122|141657754|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was \>0.67.|GMT Ratio (B strain-high risk group)|1.11|||||TWO_SIDED|95.0|0.95|1.3||||||||1.3|0.95|
71074332|NCT01162122|141657755|SUPERIORITY_OR_OTHER||GMT ratio (H3N2/Brisbane-overall)|1.49|||||TWO_SIDED|95.0|1.33|1.67||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was \>1.5.||1.67|1.33|
71074333|NCT01162122|141657755|SUPERIORITY_OR_OTHER||GMT ratio(H3N2/Wisconsin-overall)|1.38|||||TWO_SIDED|95.0|1.25|1.52||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was \>1.5.||1.52|1.25|
71074334|NCT01162122|141657755|SUPERIORITY_OR_OTHER||GMT ratio (B strain-overall)|1.09|||||TWO_SIDED|95.0|0.99|1.21||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was \>1.5.||1.21|0.99|
71074335|NCT01162122|141657755|SUPERIORITY_OR_OTHER||GMT ratio (H3N2/Brisbane-high risk)|1.36|||||TWO_SIDED|95.0|1.15|1.61||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was \>1.5.||1.61|1.15|
71074336|NCT01162122|141657755|SUPERIORITY_OR_OTHER||GMT ratio(H3N2/Wisconsin-high risk)|1.28|||||TWO_SIDED|95.0|1.1|1.48||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was \>1.5.||1.48|1.1|
70940459|NCT01044901|141381036|OTHER|||||||0.14||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Wilcoxon (Mann-Whitney)|||Primary outcome was presented at baseline as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon (Mann-Whitney) test.||||0.14
70940460|NCT01044901|141381037|OTHER|||||||0.13||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.13
71074337|NCT01162122|141657755|SUPERIORITY_OR_OTHER||GMT ratio (B strain-high risk)|1.13|||||TWO_SIDED|95.0|0.97|1.31||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was \>1.5.||1.31|0.97|
71074338|NCT01162122|141657756|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 heterologous strains was ≥-10%.|Group difference (H3N2/Brisbane-overall)|11.3|||||TWO_SIDED|95.0|6.7|15.9||||||||15.9|6.7|
71074339|NCT01162122|141657756|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 heterologous strains was ≥-10%.|Group difference(H3N2/Wisconsin-overall)|11.9|||||TWO_SIDED|95.0|7.3|16.6||||||||16.6|7.3|
71074340|NCT01162122|141657756|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.|Slope|4.0|||||TWO_SIDED|95.0|-0.4|8.4||||||||8.4|-0.4|
71074341|NCT01162122|141657756|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 heterologous strains was ≥-10%.|Group difference(H3N2/Brisbane-high risk|12.3|||||TWO_SIDED|95.0|4.8|19.9||||||||19.9|4.8|
71074342|NCT01162122|141657756|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.|Group difference(H3N2Wisconsin-high risk|12.6|||||TWO_SIDED|95.0|5.0|20.2||||||||20.2|5.0|
71074343|NCT01162122|141657756|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 heterologous strains was ≥-10%.|Group difference (B strain-high risk)|4.8|||||TWO_SIDED|95.0|-2.1|11.8||||||||11.8|-2.1|
71074344|NCT01162122|141657757|SUPERIORITY_OR_OTHER||Group difference (H3N2/Brisbane-overall)|12.5|||||TWO_SIDED|95.0|8.1|16.9||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was \>10%.||16.9|8.1|
71074345|NCT01162122|141657757|SUPERIORITY_OR_OTHER||Group difference(H3N2/Wisconsin-overall)|12.6|||||TWO_SIDED|95.0|8.1|17.1||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was \>10%.||17.1|8.1|
71074346|NCT01162122|141657757|SUPERIORITY_OR_OTHER||Group difference (B strain-overall)|4.6|||||TWO_SIDED|95.0|0.4|8.8||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was \>10%.||8.8|0.4|
71074347|NCT01162122|141657757|SUPERIORITY_OR_OTHER||Group difference(H3N2/Brisbane-high risk|12.4|||||TWO_SIDED|95.0|5.2|19.6||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was \>10%.||19.6|5.2|
71074348|NCT01162122|141657757|SUPERIORITY_OR_OTHER||Group difference(H3N2/Wisconsin-highrisk|13.0|||||TWO_SIDED|95.0|5.8|20.3||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was \>10%.||20.3|5.8|
71074349|NCT01162122|141657757|SUPERIORITY_OR_OTHER||Group difference (B strain-high risk)|5.1|||||TWO_SIDED|95.0|-1.6|11.8||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was \>10%.||11.8|-1.6|
71074350|NCT03313310|141657778|OTHER|A one-sample non-parametric test for change between baseline and 8-month follow-up was conducted.||||||0.98||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.98
71074351|NCT03313310|141657778|OTHER|A one-sample non-parametric test for change between baseline and 3-month follow-up was conducted.||||||0.05||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.05
71074352|NCT03313310|141657779|OTHER|A one-sample non-parametric test for change between baseline and 8-month follow-up was conducted.||||||0.39||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.39
71074353|NCT03313310|141657779|OTHER|A one-sample non-parametric test for change between baseline and 3-month follow-up was conducted.||||||0.76||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.76
71074354|NCT03313310|141657780|OTHER|A one-sample non-parametric test for change between baseline and 8-month follow-up was conducted.|||||<|0.001||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||<0.001
71074355|NCT03313310|141657780|OTHER|A one-sample non-parametric test for change between baseline and 3-month follow-up was conducted.||||||0.02||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.02
71074356|NCT03313310|141657781|OTHER|A one-sample non-parametric test for change between baseline and 8-month follow-up was conducted.||||||0.51||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.51
71074357|NCT03313310|141657781|OTHER|A one-sample non-parametric test for change between baseline and 3-month follow-up was conducted.||||||0.17||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.17
71074358|NCT03313310|141657782|OTHER||||||||||||||||||A one-sample McNemar's test for change between baseline and 8-month follow-up was planned. The a priori threshold for statistical significance was set at 0.10. However, McNemar's test statistic could not be calculated due to small cell counts.|||
71074359|NCT03313310|141657782|OTHER||||||||||||||||||A one-sample McNemar's test for change between baseline and 3-month follow-up was planned. The a priori threshold for statistical significance was set at 0.10. However, McNemar's test statistic could not be calculated due to small cell counts.|||
71074360|NCT03313310|141657783|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
71074361|NCT03313310|141657783|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||0.5||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.50
71115914|NCT03479541|141738379|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.0001||||0.247|TWO_SIDED|95.0|-0.0001|0.0004||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Normalized Damping (VS/EO)||0.0004|-0.0001|0.247
70940461|NCT01044901|141381038|OTHER|||||||0.81||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.81
70940462|NCT01044901|141381039|OTHER|||||||0.3||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.30
70940463|NCT02878590|141381046|SUPERIORITY|||||||0.0093|||||||t-test, 2 sided|||||||0.0093
71074362|NCT03313310|141657784|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||0.63||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.63
70940464|NCT02706834|141381074|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence interval of 0.80 to 1.25|Point estimate|0.43|||||TWO_SIDED|90.0|0.38|0.487|||||Exponentiated Least Square Means TAK-828 100 mg Fed/TAK-828 100 mg Fasted|Food Effect: A linear mixed effect model on the natural log (ln)-transformed parameters was performed with dosing condition as a fixed effect and participant as a random effect using the Kenward-Roger estimation for computing the denominator degrees of freedom. The least squares means and difference of least squared means for the ln-transformed parameters were exponentiated to obtain the geometric means on the original scale.||0.487|0.380|
71115915|NCT03479541|141738379|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.0004||||0.008|TWO_SIDED|95.0|0.0001|0.0007||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Normalized Damping (SS+VSEO)||0.0007|0.0001|0.008
71115916|NCT03479541|141738380|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.004||||0.003|TWO_SIDED|95.0|-0.006|-0.001||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Evoked Center of Mass (CoM) Sway (VS/EO)||-0.001|-0.006|0.003
71115917|NCT03479541|141738380|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.001||||0.004|TWO_SIDED|95.0|-0.003|-0.0005||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Evoked CoM Sway (SS+VS/EO)||-0.0005|-0.003|0.004
71074363|NCT03313310|141657784|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
71074364|NCT03313310|141657785|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
71074365|NCT03313310|141657785|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||0.25||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.25
71115918|NCT03479541|141738381|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.004||||0.031|TWO_SIDED|95.0|-0.007|-0.0003||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Internal Sensory Noise (VS/EO)||-0.0003|-0.007|0.031
70940465|NCT02706834|141381081|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence interval of 0.80 to 1.25|Point estimate|0.896|||||TWO_SIDED|90.0|0.833|0.964|||||Exponentiated Least Square Means TAK-828 100 mg Fed/TAK-828 100 mg Fasted|Food Effect: A linear mixed effect model on the natural log (ln)-transformed parameters was performed with dosing condition as a fixed effect and participant as a random effect using the Kenward-Roger estimation for computing the denominator degrees of freedom. The least squares means and difference of least squared means for the ln-transformed parameters were exponentiated to obtain the geometric means and ratios of geometric means on the original scale.||0.964|0.833|
71074366|NCT03313310|141657786|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
70940466|NCT03149887|141381083|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||||||0.66
71115919|NCT03479541|141738381|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.003||||0.003|TWO_SIDED|95.0|-0.005|-0.0003||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Internal Sensory Noise (SS+VS/EO)||-0.0003|-0.005|0.003
71115920|NCT03479541|141738382|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age and gender), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0321||||0.3221|TWO_SIDED|95.0|-0.0957|0.0315||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.0315|-0.0957|0.3221
71115921|NCT03479541|141738383|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0136||||0.336|TWO_SIDED|95.0|-0.0413|0.0142||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.0142|-0.0413|0.336
71115922|NCT03479541|141738384|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0406||||0.033|TWO_SIDED|95.0|-0.0779|-0.0032||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||-0.0032|-0.0779|0.033
71115923|NCT00107900|141738386|SUPERIORITY_OR_OTHER|||||||0.238|TWO_SIDED||||||Fisher Exact|||||||0.238
71115924|NCT02644096|141738390|SUPERIORITY_OR_OTHER||||||<|0.05||||||Changes in physical function after 3 months|unpaired t-test|||"Power calculation in this study was based on findings in a previous cross-sectional study.~The physical dimensions in health status was the primary outcome variable. The mean physical score was 49.4, SD was 26.1; alpha in this study was set to 5% and β to 20%. We considered that the intervention could lead to an improvement of 50% in the physical health score and were willing to overlook a difference in score of 12. When the sample size was calculated, 68 patients were needed in both groups."||||<0.05
71115925|NCT03224403|141738398|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test from SAS PROC LIFETEST|||||||<0.001
71115926|NCT03224403|141738398|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test from SAS PROC LIFETEST|||||||<0.001
71115927|NCT03224403|141738398|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test from SAS PROC LIFETEST|||||||<0.001
71074367|NCT03313310|141657786|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
71115928|NCT03224403|141738398|SUPERIORITY|||||||0.035||||||The significance threshold level was 0.049 (two-sided). P-values are from the comparison of median survival time using the bootstrap re-sampling method.|bootstrap re-sampling method|||||||0.035
71115929|NCT03224403|141738398|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are from the comparison of median survival time using the bootstrap re-sampling method.|bootstrap re-sampling method|||||||<0.001
71115930|NCT03224403|141738399|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test from SAS PROC LIFETEST|||||||<0.001
71115931|NCT03224403|141738399|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test from SAS PROC LIFETEST|||||||<0.001
71115932|NCT03224403|141738399|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test from SAS PROC LIFETEST|||||||<0.001
71115933|NCT03224403|141738399|SUPERIORITY|||||||0.671||||||The significance threshold level was 0.049 (two-sided). P-values are from the comparison of median survival time using the bootstrap re-sampling method.|bootstrap re-sampling method|||||||0.671
71115934|NCT03224403|141738399|SUPERIORITY|||||||0.487||||||The significance threshold level was 0.049 (two-sided). P-values are from the comparison of median survival time using the bootstrap re-sampling method.|bootstrap re-sampling method|||||||0.487
71115935|NCT03224403|141738400|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71115936|NCT03224403|141738401|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71115937|NCT03224403|141738402|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
70940467|NCT03149887|141381084|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||||||0.54
70940468|NCT03149887|141381085|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
70940469|NCT03149887|141381086|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
71074368|NCT03313310|141657787|OTHER||||||||||||||||||A one-sample McNemar's test for change between baseline and 8-month follow-up was planned. The a priori threshold for statistical significance was set at 0.10. However, McNemar's test statistic could not be calculated due to small cell counts.|||
71074369|NCT03313310|141657787|OTHER||||||||||||||||||A one-sample McNemar's test for change between baseline and 3-month follow-up was planned. The a priori threshold for statistical significance was set at 0.10. However, McNemar's test statistic could not be calculated due to small cell counts.|||
71115938|NCT03224403|141738403|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71115939|NCT03224403|141738404|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71115940|NCT03224403|141738405|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71115941|NCT03224403|141738406|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71115942|NCT03224403|141738407|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71074370|NCT03313310|141657789|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
71074371|NCT03313310|141657789|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
71074372|NCT03313310|141657790|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
71074373|NCT03313310|141657790|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||0.75||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.75
71074374|NCT03313310|141657791|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||0.55||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.55
71115943|NCT03224403|141738408|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71115944|NCT03224403|141738409|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71074375|NCT03313310|141657791|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
71074376|NCT03313310|141657792|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||0.45||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.45
71074377|NCT03313310|141657792|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||0.07||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.07
71074378|NCT00926536|141657793|SUPERIORITY_OR_OTHER||Mean Difference (Net)|71.6|||<|0.001|TWO_SIDED|||||Decrease in DAP in C-arm CT +DSA group when compared to DSA only|Mixed Models Analysis|||||||<.001
71074379|NCT00926536|141657794|SUPERIORITY_OR_OTHER||Mean Difference (Net)|158.3||||0.017|TWO_SIDED|||||Decrease in CD in C-arm CT +DSA group when compared to DSA only|Mixed Models Analysis|||||||0.017
71115945|NCT03224403|141738410|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71115946|NCT03224403|141738411|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71115947|NCT03224403|141738412|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71115948|NCT03224403|141738413|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71115949|NCT03224403|141738414|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71115950|NCT03224403|141738415|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71115951|NCT03224403|141738416|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71115952|NCT03224403|141738417|SUPERIORITY|||||||0.007|||||||Regression, Logistic|||||||0.007
71115953|NCT03224403|141738418|SUPERIORITY|||||||0.026|||||||Regression, Logistic|||||||0.026
71115954|NCT03224403|141738419|SUPERIORITY|||||||0.08|||||||Regression, Logistic|||||||0.080
71115955|NCT01456195|141738426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.122|<|0.001|TWO_SIDED|95.0|-0.72|-0.24||MMRM model with treatment, country, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-0.24|-0.72|<0.001
71115956|NCT01456195|141738426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.122|<|0.001|TWO_SIDED|95.0|-1.0|-0.52||MMRM model with treatment, country, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-0.52|-1.00|<0.001
71115957|NCT01456195|141738427|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13||||0.01|TWO_SIDED|95.0|1.2|3.79||P-Value used a logistic model with treatment, country and baseline HbA1c as explanatory variables.|Regression, Logistic|||||3.79|1.20|0.010
71115958|NCT01456195|141738427|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.001|TWO_SIDED|95.0|2.48|7.82||P-Value used a logistic model with treatment, country and baseline HbA1c as explanatory variables.|Regression, Logistic|||||7.82|2.48|<0.001
71115959|NCT01456195|141738428|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.7|STANDARD_ERROR_OF_MEAN|4.59||0.003|TWO_SIDED|95.0|-22.7|-4.6||Mixed Model Repeated Measures (MMRM) model with treatment, country, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-4.6|-22.7|0.003
71115960|NCT01456195|141738428|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.3|STANDARD_ERROR_OF_MEAN|4.6|<|0.001|TWO_SIDED|95.0|-31.4|-13.2||MMRM model with treatment, country, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-13.2|-31.4|<0.001
71115961|NCT01456195|141738429|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.8|STANDARD_ERROR_OF_MEAN|17.17||0.1|TWO_SIDED|95.0|-63.2|5.7||ANCOVA model with treatment and country as fixed factors and baseline value as covariate.|ANCOVA|||||5.7|-63.2|0.100
71115962|NCT01456195|141738429|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.0|STANDARD_ERROR_OF_MEAN|17.7||0.096|TWO_SIDED|95.0|-65.5|5.5||ANCOVA model with treatment and country as fixed factors and baseline value as covariate.|ANCOVA|||||5.5|-65.5|0.096
71115963|NCT01340625|141738431|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|107.84|||||TWO_SIDED|90.0|100.91|115.24|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||115.24|100.91|
71115964|NCT01340625|141738432|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|104.03|||||TWO_SIDED|90.0|96.74|111.88|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||111.88|96.74|
71115965|NCT01340625|141738433|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|101.97|||||TWO_SIDED|90.0|95.73|108.62|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.62|95.73|
71115966|NCT01340625|141738434|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.24|||||TWO_SIDED|90.0|90.04|102.86|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||102.86|90.04|
71115967|NCT01340625|141738435|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.8|||||TWO_SIDED|90.0|93.89|103.97|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||103.97|93.89|
71115968|NCT01340625|141738436|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.59|||||TWO_SIDED|90.0|94.91|104.5|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104.50|94.91|
71115969|NCT01668628|141738438|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||t-test, 2 sided|||Student's t-test: Comparison of baseline physical health score between Normohydration group and Overhydration group.||||0.008
71115970|NCT01668628|141738438|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||t-test, 2 sided|||Student's t test: Comparison of baseline mental health score between Normohydration group and Overhydration group.||||0.008
71115971|NCT01668628|141738438|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||t-test, 2 sided|||Student's t test: Comparison of baseline kidney disease component score between Normohydration group and Overhydration group||||0.008
71115972|NCT01668628|141738438|SUPERIORITY_OR_OTHER|||||||0.157|TWO_SIDED||||||t-test, 2 sided|||Student's t test: Comparison of baseline BDI score between Normohydration group and Overhydration group.||||0.157
71115973|NCT00734604|141738449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.04||0.001|TWO_SIDED|95.0|0.04|0.19||p-value is for difference in LS Means change from baseline between tadalafil OaD and Sildenafil PRN.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.19|0.04|0.001
71115974|NCT00734604|141738450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.872|TWO_SIDED|95.0|-0.06|0.08||p-value is for difference in Pairs Sexual Self-Confidence Domain Score LS Mean and Change from Baseline between Tadalafil OaD and Tadalafil PRN Population|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.|LS Mean difference = Tadalafil OaD-Tadalafil PRN|||0.08|-0.06|0.872
71115975|NCT00734604|141738451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|0.1|0.2||p-value is for difference between Tadalafil OaD and Sildenafil PRN change from baseline in LS Mean.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.20|0.10|<0.001
71115976|NCT00734604|141738451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.03||0.395|TWO_SIDED|95.0|-0.03|0.07||p-value is for difference between Tadalafil OaD and Tadalafil PRN in change from baseline in LS Mean.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.07|-0.03|0.395
71115977|NCT00734604|141738452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|-0.36|-0.25||p-value is for the difference between Tadalafil OaD and Sildenafil PRN in Change from Baseline in LS Mean.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||-0.25|-0.36|<0.001
71115978|NCT00734604|141738452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|-0.2|-0.08||p-value is for the difference between Tadalafil OaD and Tadalafil PRN in Change from Baseline in LS Mean.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||-0.08|-0.20|<0.001
70940470|NCT03149887|141381087|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||||||0.53
70940471|NCT03149887|141381088|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
70940472|NCT03149887|141381089|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||||||0.76
70940473|NCT03149887|141381090|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||||||0.44
70940474|NCT03034772|141381122|SUPERIORITY|||||||0.04|||||||ANCOVA|Mean difference between the 2 groups derived using analysis of covariance, with the baseline value and type of anti-VEGF drug used as covariates.||||||0.04
70940475|NCT03034772|141381123|SUPERIORITY|||||||0.11|||||||ANCOVA|Mean difference between the 2 groups derived using analysis of covariance, with the baseline value and type of anti-VEGF drug used as covariates.||||||0.11
70940476|NCT03034772|141381124|SUPERIORITY|||||||0.01|||||||ANCOVA|Mean difference between the 2 groups derived using analysis of covariance, with the baseline value and type of anti-VEGF drug used as covariates.||||||0.01
70940477|NCT03034772|141381125|SUPERIORITY|||||||0.78|||||||ANCOVA|||||||0.78
70940478|NCT03034772|141381126|SUPERIORITY|||||||0.24|||||||ANCOVA|||||||0.24
70940479|NCT00116584|141381131|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
70940480|NCT00116584|141381132|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70940481|NCT00116584|141381133|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71115979|NCT00734604|141738453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.3||0.004|TWO_SIDED|95.0|-1.43|-0.27||p-value is for the difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||-0.27|-1.43|0.004
71115980|NCT00734604|141738453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.29||0.007|TWO_SIDED|95.0|-1.37|-0.22||p-value is for the difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||-0.22|-1.37|0.007
71115981|NCT00734604|141738454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|0.03|0.09||p-value is for difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.09|0.03|<0.001
70940482|NCT01882088|141381150|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||2e-06|||||||Wilcoxon (Mann-Whitney)|||Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||0.000002
70940483|NCT01882088|141381151|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||0.2
70940484|NCT01882088|141381152|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.002415|||||||Wilcoxon (Mann-Whitney)|||||||0.002415
70940485|NCT01882088|141381153|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.000438|||||||Wilcoxon (Mann-Whitney)|||||||0.000438
70940486|NCT01882088|141381154|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.023|||||||Wilcoxon (Mann-Whitney)|||||||0.023
70940487|NCT01882088|141381155|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
70940488|NCT01882088|141381156|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
70940489|NCT01882088|141381157|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.94|||||||Wilcoxon (Mann-Whitney)|||||||0.94
70940490|NCT01882088|141381158|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
70940491|NCT01882088|141381159|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||2e-05|||||||Wilcoxon (Mann-Whitney)|||||||0.00002
70940492|NCT00125619|141381160|SUPERIORITY_OR_OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Between group comparison of Robot (Lokomat) vs. Manual (therapist-assisted) training.||||0.72
70940493|NCT00125619|141381160|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within group test for change pre- vs. post-training due to Robot (Lokomat) training.||||<.05
71115982|NCT00734604|141738454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|0.06|0.12||p-value is for difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.12|0.06|<0.001
70940494|NCT00125619|141381160|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks|||Within group test for change pre- vs. post-training due to Manual (Therapist Assisted) training.||||>.05
70940495|NCT00125619|141381161|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between-groups comparison of Robot vs. Manual training.||||>0.05
71074380|NCT01080391|141657802|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.57|0.834||Analysis was stratified by β2 microglobulin levels (\< 2.5 mg/L vs. ≥ 2.5 mg/L), prior bortezomib (no vs. yes), and prior lenalidomide (no vs. yes)|Log Rank|The stopping boundary for this analysis was 0.0127 based on 1-sided significance level (O'Brien-Fleming with Lan-DeMets spending function).||||0.834|0.570|< 0.0001
71074381|NCT01080391|141657803|SUPERIORITY|The stopping boundary for this analysis was 0.0231 based on 1-sided significance level (O'Brien-Fleming with Lan-DeMets spending function).|Hazard Ratio (HR)|0.794||||0.0045|TWO_SIDED|95.0|0.667|0.945|||Log Rank|Analysis was stratified by β2 microglobulin levels (\< 2.5 mg/L vs. ≥ 2.5 mg/L), prior bortezomib (no vs. yes), and prior lenalidomide (no vs. yes).||The final analysis of OS was to be performed after 510 deaths occur. A total of 510 deaths would provide 85% power to detect, with a 1-sided significance level of 0.025, a hazard ratio of 0.765 corresponding to a 23.5% reduction in risk for death for CRd versus Rd (39.2 vs. 30.0 months, respectively).||0.945|0.667|0.0045
71115983|NCT00734604|141738455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.91|-0.36||p-value is for difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||-0.36|-0.91|<0.001
70940496|NCT00125619|141381161|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks|||Within groups comparison (pre- vs. post-treatment) due to Manual (therapist-assisted) treatment.||||>.05
70940497|NCT00125619|141381161|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within-groups comparison of pre- vs. post-treatment effects for Robot (Lokomat) training.||||<.05
70940498|NCT00125619|141381162|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between-groups comparison of robot vs. manual training.||||>.05
71074382|NCT01080391|141657804|SUPERIORITY||Odds Ratio (OR)|3.472|||<|0.0001|TWO_SIDED|95.0|2.411|5.001|||Cochran-Mantel Haenszel chi-square test|Cochran-Mantel Haenszel chi-square test with β2 macroglobulin level, prior bortezomib, and prior lenalidomide as stratification factors.|The odds ratio and 95% CI were estimated using the Mantel-Haenszel method.|||5.001|2.411|< 0.0001
71115984|NCT00734604|141738455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.78|-0.23||p-value is for difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.|t-test|||||-0.23|-0.78|<0.001
71115985|NCT00734604|141738456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.055|TWO_SIDED|95.0|-0.44|0.0||p-value is for the difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.00|-0.44|0.055
70940499|NCT00125619|141381162|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-treatment effects for manual training.||||>.05
70940500|NCT00125619|141381162|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon signed ranks|||Within group comparison of pre- vs. post-treatment effects of robot training.||||>.05
70940501|NCT00125619|141381163|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between groups comparison of effects of robot vs. manual training.||||>.05
70940502|NCT00125619|141381163|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks|||Within groups comparison of pre- vs. post-treatment effects of manual training.||||>.05
70940503|NCT00125619|141381163|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-training effects of robot training.||||<.05
70940504|NCT00125619|141381164|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between groups comparison of robot vs. manual training.||||>.05
70940505|NCT00125619|141381164|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Within groups comparison for pre- vs. post-training effects of manual training.||||>.05
70940506|NCT00125619|141381164|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Within group comparison for pre- vs. post-training effects of robot training.||||>.05
70940507|NCT00125619|141381165|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between groups comparison of robot vs. manual training.||||>.05
70940508|NCT00125619|141381165|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-training effects of manual training.||||>.05
70940509|NCT00125619|141381165|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-treatment effects of robot training.||||<.05
70940510|NCT00125619|141381166|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between groups comparison of robot vs. manual training.||||>.05
70940511|NCT00125619|141381166|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-training effects of manual training.||||<.05
71074383|NCT01080391|141657805|SUPERIORITY||Odds Ratio (OR)|1.897||||0.0044|TWO_SIDED|95.0|1.17|3.08|||Cochran-Mantel Haenszel chi-square test|Cochran-Mantel Haenszel chi-square test with β2 macroglobulin level, prior bortezomib, and prior lenalidomide as stratification factors.|The odds ratio and 95% CI were estimated using the Mantel-Haenszel method.|||3.08|1.17|0.0044
71074384|NCT00672841|141657815|SUPERIORITY_OR_OTHER||Sensitivity|100.0||||||95.0|||||Sensitivity %||Sensitivity \[1\] = (True positives \[n=6\]/ True positives + False negatives \[n=6\])|Clinical sensitivity of the BDG test was calculated for both study groups combined||||
71074385|NCT00672841|141657815|SUPERIORITY_OR_OTHER||Specificity|50.0||||||95.0|||||% Specificity||Specificity \[0.50\]= True negatives \[n=28\]/ True negatives + False positives \[56\])|Clinical specificity of the BDG test was calculated for the study groups combined||||
71074386|NCT00672841|141657817|SUPERIORITY_OR_OTHER||Percent Sensitivity|100.0||||||95.0|||||Sensitivity||Sensitivity = (true positives \[n=6\]/true positives + false negative \[n=6\])|The clinic sensitivity of the BDG test was calculated for both study groups combined||||
71074387|NCT00672841|141657817|SUPERIORITY_OR_OTHER||Percent Specificity|52.0||||||95.0|||||Specificity||Specificity \[0.52\]= (True negatives \[n=30\]/True negatives + false positives \[n=58\])|The clinical specificity of the BDG test was calculated for both study groups combined||||
71074388|NCT03578146|141657819|SUPERIORITY||Least Squares Means (Difference)|-73.14||||0.0121|TWO_SIDED||||||ANCOVA|||||||0.0121
71074389|NCT03578146|141657819|SUPERIORITY||Least Squares Means (Difference)|-153.99|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71074390|NCT03578146|141657819|SUPERIORITY||Least Squares Means (Difference)|-189.57|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71074391|NCT03578146|141657819|SUPERIORITY||Least Squares Means (Difference)|-239.3|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71074392|NCT03578146|141657819|SUPERIORITY||Least Squares Means (Difference)|-231.12|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71074393|NCT03578146|141657820|SUPERIORITY||Least Squares Means (Difference)|52837.94|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71074394|NCT03578146|141657820|SUPERIORITY||Least Squares Means (Difference)|110388.3|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71074395|NCT03578146|141657820|SUPERIORITY||Least Squares Means (Difference)|163880.7|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71074396|NCT03578146|141657820|SUPERIORITY||Least Squares Means (Difference)|263236.5|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71074397|NCT03578146|141657820|SUPERIORITY||Least Squares Means (Difference)|270297.2|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
70940512|NCT00125619|141381166|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-treatment effects of robot training.||||<.05
71074398|NCT03578146|141657821|SUPERIORITY||Least Squares Means (Difference)|-9.91||||0.002|TWO_SIDED||||||ANCOVA|||||||0.002
71074399|NCT03578146|141657821|SUPERIORITY||Least Squares Means (Difference)|-15.06|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71074400|NCT03578146|141657821|SUPERIORITY||Least Squares Means (Difference)|-17.53|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71074401|NCT03578146|141657821|SUPERIORITY||Least Squares Means (Difference)|-17.05|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71074402|NCT03578146|141657821|SUPERIORITY||Least Squares Means (Difference)|-19.33|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71074403|NCT01260584|141657857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.7|STANDARD_ERROR_OF_MEAN|4.11||0.0624|TWO_SIDED|95.0|-0.4|15.8|||Mixed Models Analysis|||For the sample size calculations for the co-primary endpoints, no Type 1 error rate was adjusted and both co-primary endpoints will be tested at the 0.05 level.||15.8|-0.4|0.0624
71074404|NCT01260584|141657857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.8|STANDARD_ERROR_OF_MEAN|3.35|<|0.0001|TWO_SIDED|95.0|25.1|38.4|||Mixed Models Analysis|||||38.4|25.1|<0.0001
71074405|NCT01260584|141657857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|4.08||0.244|TWO_SIDED|95.0|-3.3|12.8|||Mixed Models Analysis|||||12.8|-3.3|0.2440
71074406|NCT01260584|141657857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.7|STANDARD_ERROR_OF_MEAN|3.17|<|0.0001|TWO_SIDED|95.0|28.4|41.0|||Mixed Models Analysis|||||41.0|28.4|<0.0001
71074407|NCT01260584|141657857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.0|STANDARD_ERROR_OF_MEAN|4.14|<|0.0001|TWO_SIDED|95.0|18.8|35.2|||Mixed Models Analysis|||||35.2|18.8|<0.0001
71074408|NCT01260584|141657858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.2|STANDARD_ERROR_OF_MEAN|12.65||0.0048|TWO_SIDED|95.0|-61.1|-11.2|||Mixed Models Analysis|||||-11.2|-61.1|0.0048
71074409|NCT01260584|141657858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-93.8|STANDARD_ERROR_OF_MEAN|11.54|<|0.0001|TWO_SIDED|95.0|-116.7|-71.0|||Mixed Models Analysis|||||-71.0|-116.7|<0.0001
71074410|NCT01260584|141657858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.2|STANDARD_ERROR_OF_MEAN|12.53||0.0924|TWO_SIDED|95.0|-45.9|3.5|||Mixed Models Analysis|||||3.5|-45.9|0.0924
71074411|NCT01260584|141657858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-108.8|STANDARD_ERROR_OF_MEAN|10.85|<|0.0001|TWO_SIDED|95.0|-130.3|-87.3|||Mixed Models Analysis|||||-87.3|-130.3|<0.0001
71074412|NCT01260584|141657858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-72.6|STANDARD_ERROR_OF_MEAN|12.73|<|0.0001|TWO_SIDED|95.0|-97.8|-47.5|||Mixed Models Analysis|||||-47.5|-97.8|<0.0001
71074413|NCT01260584|141657859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.6|STANDARD_ERROR_OF_MEAN|3.72||0.0423|TWO_SIDED|95.0|-15.0|-0.3|||Mixed Models Analysis|||||-0.3|-15.0|0.0423
71074414|NCT01260584|141657859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.7|STANDARD_ERROR_OF_MEAN|3.19|<|0.0001|TWO_SIDED|95.0|-29.0|-16.4|||Mixed Models Analysis|||||-16.4|-29.0|<0.0001
71074415|NCT01260584|141657859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.8|STANDARD_ERROR_OF_MEAN|3.7||0.1184|TWO_SIDED|95.0|-13.1|1.5|||Mixed Models Analysis|||||1.5|-13.1|0.1184
71074416|NCT01260584|141657859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.5|STANDARD_ERROR_OF_MEAN|3.02|<|0.0001|TWO_SIDED|95.0|-30.5|-18.5|||Mixed Models Analysis|||||-18.5|-30.5|<0.0001
71074417|NCT01260584|141657859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.9|STANDARD_ERROR_OF_MEAN|3.76|<|0.0001|TWO_SIDED|95.0|-24.3|-9.5|||Mixed Models Analysis|||||-9.5|-24.3|<0.0001
71115986|NCT00734604|141738456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.046|TWO_SIDED|95.0|-0.44|0.0||p-value is for the difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.00|-0.44|0.046
71115987|NCT00734604|141738457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.66|STANDARD_ERROR_OF_MEAN|1.27||0.004|TWO_SIDED|95.0|1.16|6.17||p-value is for the difference between Tadalafil PRN and Sildenafil PRN change in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||6.17|1.16|0.004
71115988|NCT00734604|141738457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.55|STANDARD_ERROR_OF_MEAN|1.27||0.006|TWO_SIDED|95.0|-6.05|-1.04||p-value is for the difference between Tadalafil OaD and Tadalafil PRN change in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||-1.04|-6.05|0.006
71115989|NCT00734604|141738459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|1.05||0.915|TWO_SIDED|95.0|-1.95|2.17||p-value is for the difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||2.17|-1.95|0.915
71115990|NCT00734604|141738459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|1.04||0.212|TWO_SIDED|95.0|-3.35|0.74||p-value is for the difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.74|-3.35|0.212
71115991|NCT00734604|141738460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.403|TWO_SIDED|95.0|-0.09|0.22||p-value is for the difference between Tadalafil OaD and Sildenafil PRN in LS Means.|Generalized Linear Mixed Model|||||0.22|-0.09|0.403
71115992|NCT00734604|141738460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.367|TWO_SIDED|95.0|-0.08|0.23||p-value is for the difference between Tadalafil OaD and Tadalafil PRN in LS Means.|Generalized Linear Mixed Model|||||0.23|-0.08|0.367
70940513|NCT01533181|141381185|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.9||||0.0001|TWO_SIDED|95.0|1.9|8.1|||Kaplan-Meier|||||8.1|1.9|0.0001
71074418|NCT01260584|141657860|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06||||0.1331|TWO_SIDED|95.0|0.8|5.32|||Regression, Logistic|||||5.32|0.80|0.1331
71074419|NCT01260584|141657860|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.99||||0.5813|TWO_SIDED|95.0|0.17|23.65|||Regression, Logistic|||||23.65|0.17|0.5813
71074420|NCT01260584|141657860|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.54||||0.0127|TWO_SIDED|95.0|1.85|148.23|||Regression, Logistic|||||148.23|1.85|0.0127
71074421|NCT01260584|141657860|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.11||||0.0013|TWO_SIDED|95.0|3.13|93.65|||Regression, Logistic|||||93.65|3.13|0.0013
71074422|NCT01260584|141657861|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.5684|TWO_SIDED|95.0|0.49|3.67|||Regression, Logistic|||||3.67|0.49|0.5684
71074423|NCT01260584|141657861|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.7||||0.0447|TWO_SIDED|95.0|1.05|42.92|||Regression, Logistic|||||42.92|1.05|0.0447
71074424|NCT01260584|141657861|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|58.64||||0.0003|TWO_SIDED|95.0|6.8|505.58|||Regression, Logistic|||||505.58|6.80|0.0003
71115993|NCT00734604|141738461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.06||0.002|TWO_SIDED|95.0|0.07|0.32||p-value is for the difference between Tadalafil OaD and Sildenafil PRN in LS Means.|Generalized Linear Mixed Model|||||0.32|0.07|0.002
71115994|NCT00734604|141738461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.06||0.722|TWO_SIDED|95.0|-0.15|0.1||p-value is for the difference between Tadalafil OaD and Tadalafil PRN in LS Means.|Generalized Linear Mixed Model|||||0.10|-0.15|0.722
71115995|NCT00734604|141738462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.65|-0.37||p-value is for the difference between Tadalafil OaD and Sildenafil PRN in LS Means.|Generalized Linear Mixed Model|||||-0.37|-0.65|<0.001
71115996|NCT00734604|141738462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.43|-0.16||p-value is for the difference between Tadalafil OaD and Tadalafil PRN in LS Means.|Generalized Linear Mixed Model|||||-0.16|-0.43|<0.001
71115997|NCT00734604|141738463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.06||0.07|TWO_SIDED|95.0|-0.01|0.22||p-value is for the difference between Tadalafil OaD and Sildenafil PRN in LS Means.|Generalized Linear Mixed Model|||||0.22|-0.01|0.070
71115998|NCT00734604|141738463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.637|TWO_SIDED|95.0|-0.14|0.09||p-value is for the difference between Tadalafil OaD and Tadalafil PRN in LS Means.|Generalized Linear Mixed Model|||||0.09|-0.14|0.637
71115999|NCT02589665|141738464|SUPERIORITY||Odds Ratio (OR)|2.93|||||TWO_SIDED|95.0|0.7|12.27||||||||12.27|0.70|
71116000|NCT02589665|141738464|SUPERIORITY||Odds Ratio (OR)|7.22|||||TWO_SIDED|95.0|1.88|27.65||||||||27.65|1.88|
71116001|NCT02589665|141738464|SUPERIORITY||Odds Ratio (OR)|3.61|||||TWO_SIDED|95.0|0.92|14.17||||||||14.17|0.92|
71116002|NCT02589665|141738465|SUPERIORITY||Odds Ratio (OR)|3.95|||||TWO_SIDED|95.0|1.73|8.98||||||||8.98|1.73|
71116003|NCT02589665|141738465|SUPERIORITY||Odds Ratio (OR)|6.78|||||TWO_SIDED|95.0|2.94|15.63||||||||15.63|2.94|
71074425|NCT01260584|141657861|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.71||||0.0006|TWO_SIDED|95.0|2.95|46.52|||Regression, Logistic|||||46.52|2.95|0.0006
71116004|NCT02589665|141738465|SUPERIORITY||Odds Ratio (OR)|2.78|||||TWO_SIDED|95.0|1.23|6.29||||||||6.29|1.23|
71116005|NCT02589665|141738466|SUPERIORITY|||||||0.986|||||||Mantel Haenszel|||||||0.986
71116006|NCT02589665|141738466|SUPERIORITY|||||||0.553|||||||Mantel Haenszel|||||||0.553
71116007|NCT02589665|141738466|SUPERIORITY|||||||0.56|||||||Mantel Haenszel|||||||0.560
71116008|NCT02589665|141738467|SUPERIORITY||Odds Ratio (OR)|2.29|||||TWO_SIDED|95.0|0.8|6.55||||||||6.55|0.80|
71116009|NCT02589665|141738468|SUPERIORITY||Mean Difference (Final Values)|22.9|||||TWO_SIDED|95.0|11.0|34.9||||||||34.9|11.0|
71116010|NCT02589665|141738468|SUPERIORITY||Mean Difference (Final Values)|20.5|||||TWO_SIDED|95.0|8.7|32.3||||||||32.3|8.7|
71116011|NCT02589665|141738468|SUPERIORITY||Mean Difference (Final Values)|10.7|||||TWO_SIDED|95.0|-1.0|22.5||||||||22.5|-1.0|
71116012|NCT02589665|141738470|SUPERIORITY||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-1.39|-0.41||||||||-0.41|-1.39|
70940514|NCT01533181|141381188|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.71|TWO_SIDED|95.0|0.6|2.2|||Kaplan-Meier|||||2.2|0.6|0.71
70940515|NCT01837719|141381190|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% CI for the ratios of geometric means of the test formulation (fixed-dose combination \[FDC\] tablet of 300/150 mg atazanavir/cobicistat) to the reference formulation (300-mg atazanavir capsule coadministered with 150-mg cobicistat) were contained within 0.80 to 1.25 for atazanavir Cmax, area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC\[0-T\]) and AUC from time 0 to infinity. (AUC\[0-T\])|Geometric mean ratio|1.073|||||TWO_SIDED|90.0|1.012|1.137|||Mixed Models Analysis||Geometric mean ratio is calculated as Treatment B/Treatment A|To demonstrate bioequivalence for atazanavir between the test (Treatment B) and reference (Treatment A) formulations, a linear mixed-effects model was applied to the natural logarithms of atazanavir Cmax, with treatment, period, and sequence as fixed effects, and participant (sequence) as a random effect.||1.137|1.012|
70940516|NCT01837719|141381190|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.423|||||TWO_SIDED|90.0|1.273|1.59|||Mixed Models Analysis||Geometric mean ratio was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when given as an FDC||1.590|1.273|
70940517|NCT01837719|141381190|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.137|||||TWO_SIDED|90.0|1.0|1.292|||Mixed Models Analysis||Geometric mean ratio is calculated as Treatment D/Treatment C|To assess the relative bioavailability of atazanavir under fasted (Treatment D) versus fed (Treatment C) states, a linear mixed-effects model was applied to the natural logarithms of atazanavir Cmax with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect.||1.292|1.000|
70940518|NCT01837719|141381190|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.862|||||TWO_SIDED|90.0|0.701|1.059|||Mixed Models Analysis||Geometric mean ratio is calculated as Treatment E/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a high fat meal and the fasted state on the natural logarithms of exposure of atazanavir when given as an FDC||1.059|0.701|
70940519|NCT01837719|141381190|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.643|||||TWO_SIDED|90.0|0.545|0.759|||Mixed Models Analysis||Geometric mean ratio is calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of high fat and light meals on the natural logarithms of exposure of atazanavir when given as an FDC||0.759|0.545|
70940520|NCT01837719|141381191|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate bioequivalence for atazanavir between the test (Treatment B) and reference (Treatment A) formulations, a linear mixed-effects model was applied to the natural logarithms of atazanavir AUC(0-T), with treatment, period, and sequence as fixed effects, and participant (sequence) as a random effect.|Geometric mean ratio|1.065|||||TWO_SIDED|90.0|1.012|1.12|||Mixed Models Analysis||Geometric mean ratio for AUC(0-T) is calculated as Treatment B/Treatment A|Bioequivalence was concluded if the 90% confidence intervals for the ratios of geometric means of the test formulation (FDC tablet of 300/150 mg atazanavir/cobicistat) to the reference formulation (300-mg atazanavir capsule coadministered with 150-mg cobicistat) were contained within 0.80 to 1.25 for atazanavir Cmax, AUC(0-T) and AUC(INF).||1.120|1.012|
70940521|NCT01837719|141381191|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.275|||||TWO_SIDED|90.0|1.166|1.393|||Mixed Models Analysis||Geometric mean ratio for AUC(0-T) was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effect and patient as a random effect was used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as an FDC||1.393|1.166|
71074426|NCT01260584|141657862|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|110.7|||||TWO_SIDED|90.0|93.7|130.8|||Mixed Models Analysis|||Prasugrel active metabolite R-138727||130.8|93.7|
71074427|NCT01260584|141657862|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|118.4|||||TWO_SIDED|90.0|99.8|140.4|||Mixed Models Analysis|||active metabolite R-130964||140.4|99.8|
71116013|NCT02589665|141738470|SUPERIORITY||Mean Difference (Final Values)|-1.06|||||TWO_SIDED|95.0|-1.54|-0.59||||||||-0.59|-1.54|
70940522|NCT01837719|141381191|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.113|||||TWO_SIDED|90.0|0.993|1.248|||Mixed Models Analysis||Geometric mean ratio for AUC(0-T) is calculated as Treatment D/Treatment C|To assess the relative bioavailability of atazanavir under fasted (Treatment D) versus fed (Treatment C) states, a linear mixed-effects model was applied to the natural logarithms of atazanavir AUC(0-T) with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect||1.248|0.993|
70940523|NCT01837719|141381191|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.95|||||TWO_SIDED|90.0|0.804|1.122|||Mixed Models Analysis||Geometric mean ratio of AUC(0-T) was calculated as Treatment E/Treatment D|A linear mixed-effect model with treatment as fixed effect and participant as a random effect will be used to estimate the effect of a high fat meal and the fasted state on the natural logarithms of exposure of atazanavir when given as an FDC.||1.122|0.804|
70940524|NCT01837719|141381191|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.746|||||TWO_SIDED|90.0|0.655|0.849|||Mixed Models Analysis||Geometric mean ratio of AUC(0-T) was calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effect and participant as a random effect will be used to estimate the effect of high fat and light meals on the natural logarithms of exposure of atazanavir when given as an FDC||0.849|0.655|
70940525|NCT01837719|141381191|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% confidence intervals for the ratios of geometric means of the test formulation (FDC tablet of 300/150 mg atazanavir/cobicistat) to the reference formulation (300-mg atazanavir capsule coadministered with 150-mg cobicistat) were contained within 0.80 to 1.25 for atazanavir Cmax, AUC(0-T) and AUC(INF).|Geometric mean ratio|1.064||||||90.0|1.011|1.12|||Mixed Models Analysis||Geometric mean ration for AUC(INF) is calculated as Treatment B/Treatment A|To demonstrate bioequivalence for atazanavir between the test (Treatment B) and reference (Treatment A) formulations, a linear mixed-effects model was applied to the natural logarithms of atazanavir AUC(0-INF), with treatment period and sequence as fixed effects, and patient (sequence) as a random effect.||1.120|1.011|
71074428|NCT01260584|141657863|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|117.9|||||TWO_SIDED|90.0|94.4|147.3|||Mixed Models Analysis||Estimation was based on the ratio of Geom. means between groups. Non-smoker is the denominator.|Prasugrel active metabolite R-138727||147.3|94.4|
71116014|NCT02589665|141738470|SUPERIORITY||Mean Difference (Final Values)|-0.59|||||TWO_SIDED|95.0|-1.07|-0.11||||||||-0.11|-1.07|
71074429|NCT01260584|141657863|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|123.8|||||TWO_SIDED|90.0|98.6|155.4|||Mixed Models Analysis||Estimation was based on the ratio of Geom. means between groups. Non-smoker is the denominator.|Clopidogrel active metabolite R-130964||155.4|98.6|
71074430|NCT03434249|141657900|OTHER|||||||0.0001|||||||Chi-squared|||"According to the results of a previous trial that looked at a probiotic's effect on infants with CI, it was estimated that when the sample size in each group is 33, the study has 80% power to detect an absolute difference of 35% in the treatment success rate (15% in the Placebo group and 50% in the treatment group) with a 0,05 alpha level.~The number of infants that was included in the study was 80, with an expected maximum dropout rate of 20%."||||0.0001
71074431|NCT03434249|141657901|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
70940526|NCT01837719|141381191|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.28|||||TWO_SIDED|90.0|1.171|1.398|||Mixed Models Analysis||Geometric mean ratio for AUC(INF) was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effect and participant as a random effect was used to estimate the effect of a light meal and fthe fasted state on the natural logarithms of exposure of atazanavir when given as an FDC||1.398|1.171|
70940527|NCT01837719|141381191|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.11|||||TWO_SIDED|90.0|0.991|1.244|||Mixed Models Analysis||Geometric mean ratio of AUC(INF) was calculated as Treatment D/Treatment C|To assess the relative bioavailability of atazanavir under fasted (Treatment D) versus fed (Treatment C) states, a linear mixed-effects model was applied to the natural logarithms of atazanavir AUC(0-INF) with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect||1.244|0.991|
70940528|NCT01837719|141381191|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.956|||||TWO_SIDED|90.0|0.81|1.128|||Mixed Models Analysis||Geometric mean of AUC(INF) was calculated as Treatment E/Treatment D|||1.128|0.810|
71074432|NCT03434249|141657903|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71074433|NCT00561470|141657914|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.817||||0.0032|TWO_SIDED|95.34|0.713|0.937||Stratified Log-Rank test p-value. Stratified on ECOG Performance Status and prior Bevacizumab according to IVRS using the Cox Proportional Hazard Model. Significance threshold was set to 0.0466 using the O'Brien-Fleming alpha spending function.|Stratified Log-Rank test||Stratified on ECOG Performance Status (0 vs 1 vs 2) and prior Bevacizumab (yes vs no) according to IVRS using the Cox Proportional Hazard Model. Significance threshold was set to 0.0466 using the O'Brien-Fleming alpha spending function.|||0.937|0.713|0.0032
71074434|NCT00561470|141657915|SUPERIORITY_OR_OTHER||Stratified Hazard ratio|0.758||||7e-05|TWO_SIDED|99.99|0.578|0.995||Stratified on ECOG Performance Status (0 vs 1 vs 2) and prior Bevacizumab (yes vs no) according to IVRS|Stratified Log-Rank test||Stratified on ECOG Performance Status (0 vs 1 vs 2) and prior Bevacizumab (yes vs no) according to IVRS using the Cox Proportional Hazard Model.|||0.995|0.578|0.00007
71074435|NCT00561470|141657916|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Stratified Cochran-Mantel-Haenszel|Stratified on ECOG Performance Status (0 vs 1 vs 2) and Prior Bevacizumab (yes vs no) according to IVRS.||||||0.0001
71074436|NCT01592292|141658017|SUPERIORITY_OR_OTHER|||||||0.3037||||||Change in DAS28 at Month 6 was performed using analysis of covariance (ANCOVA) model with baseline DAS28 score and rheumatoid factor (RF) status as covariate values.|ANCOVA|||||||0.3037
71074437|NCT01592292|141658018|SUPERIORITY_OR_OTHER|||||||0.0951||||||Change in DAS28 at Month 6 was performed using ANCOVA model with baseline DAS28 score and rheumatoid factor status as covariate values.|ANCOVA|||||||0.0951
71074438|NCT01592292|141658019|SUPERIORITY_OR_OTHER|||||||0.239||||||Change in DAS28 at Month 12 was performed using ANCOVA model with baseline DAS28 score and rheumatoid factor status as covariate values.|ANCOVA|||||||0.2390
71074439|NCT01592292|141658020|SUPERIORITY_OR_OTHER|||||||0.3212||||||Change in TJC at Month 6 was performed using ANCOVA model with baseline TJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.3212
71074440|NCT01592292|141658020|SUPERIORITY_OR_OTHER|||||||0.7097||||||Change in TJC at Month 12 was performed using ANCOVA model with baseline TJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.7097
71074441|NCT01592292|141658021|SUPERIORITY_OR_OTHER|||||||0.2444||||||Change in TJC at Month 6 was performed using ANCOVA with baseline TJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.2444
71074442|NCT01592292|141658021|SUPERIORITY_OR_OTHER|||||||0.3903||||||Change in TJC at Month 12 was performed using ANCOVA model with baseline TJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.3903
71074443|NCT01592292|141658022|SUPERIORITY_OR_OTHER|||||||0.5306||||||Change in SJC at Month 6 was performed using ANCOVA model with baseline SJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.5306
71074444|NCT01592292|141658022|SUPERIORITY_OR_OTHER|||||||0.2542||||||Change in SJC at Month 12 was performed using ANCOVA model with baseline SJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.2542
71074445|NCT01592292|141658023|SUPERIORITY_OR_OTHER|||||||0.2549||||||Change in SJC at Month 6 was performed using ANCOVA model with baseline SJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.2549
71074446|NCT01592292|141658023|SUPERIORITY_OR_OTHER|||||||0.7644||||||Change in SJC at Month 12 was performed using ANCOVA model with baseline SJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.7644
71074447|NCT01592292|141658024|SUPERIORITY_OR_OTHER|||||||0.8987||||||Change in ESR at Month 6 was performed using ANCOVA model with baseline ESR and rheumatoid factor status as covariate values.|ANCOVA|||||||0.8987
71074448|NCT01592292|141658024|SUPERIORITY_OR_OTHER|||||||0.5808||||||Change in ESR at Month 12 was performed using ANCOVA model with baseline ESR and rheumatoid factor status as covariate values.|ANCOVA|||||||0.5808
71074449|NCT01592292|141658025|SUPERIORITY_OR_OTHER|||||||0.2282||||||Change in ESR at Month 6 was performed using ANCOVA model with baseline ESR and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.2282
71074450|NCT01592292|141658025|SUPERIORITY_OR_OTHER|||||||0.5849||||||Change in ESR at Month 12 was performed using ANCOVA model with baseline ESR and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.5849
71074451|NCT01592292|141658026|SUPERIORITY_OR_OTHER|||||||0.49||||||Change in CRP at Month 6 was performed using ANCOVA model with baseline CRP and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.4900
71074452|NCT01592292|141658026|SUPERIORITY_OR_OTHER|||||||0.1826||||||Change in CRP at Month 12 was performed using ANCOVA model with baseline CRP and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.1826
71116015|NCT02589665|141738473|SUPERIORITY||Odds Ratio (OR)|3.61||||0.003|TWO_SIDED|95.0|1.57|8.31|||Regression, Logistic|||||8.31|1.57|0.003
70940529|NCT01837719|141381191|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.749|||||TWO_SIDED|90.0|0.658|0.852|||Mixed Models Analysis||Geometric mean ratio of AUC(INF) was calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effect and participant as a random effect was used to estimate the effect of high fat and light meals on the natural logarithms of exposure of atazanavir when administered as an FDC.||0.852|0.658|
70940530|NCT01837719|141381196|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.084|||||TWO_SIDED|90.0|1.014|1.158|||Mixed Models Analysis||Geometric mean ratio was calculated as Treatment B/Treatment A|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as a fixed-dose combination.||1.158|1.014|
71074453|NCT01592292|141658027|SUPERIORITY_OR_OTHER|||||||0.1894||||||Change in CRP at Month 6 was performed using ANCOVA model with baseline CRP and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.1894
71074454|NCT01592292|141658027|SUPERIORITY_OR_OTHER|||||||0.1805||||||Change in CRP at Month 12 was performed using ANCOVA model with baseline CRP and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.1805
71074455|NCT01592292|141658028|SUPERIORITY_OR_OTHER|||||||0.0568||||||Change in HAQ-DI at Month 6 was performed using ANCOVA model with baseline rheumatoid factor status as covariate value.|ANCOVA|||||||0.0568
71074456|NCT01592292|141658029|SUPERIORITY_OR_OTHER|||||||0.1167||||||Change in HAQ-DI at Month 6 was performed using ANCOVA model with baseline rheumatoid factor status as covariate value.|ANCOVA|||||||0.1167
71074457|NCT03660475|141658063|SUPERIORITY|||||||0.967|||||||t-test, 2 sided|||||||0.967
71074458|NCT03660475|141658064|SUPERIORITY|||||||0.836|||||||t-test, 2 sided|||||||0.836
71074459|NCT03660475|141658065|SUPERIORITY|||||||0.166|||||||t-test, 2 sided|||||||0.166
71074460|NCT03660475|141658066|SUPERIORITY|||||||0.638|||||||t-test, 2 sided|||||||0.638
71074461|NCT03660475|141658067|SUPERIORITY|||||||0.122|||||||t-test, 2 sided|||||||0.122
71074462|NCT03660475|141658068|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.200
70940531|NCT01837719|141381196|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.349|||||TWO_SIDED|90.0|1.215|1.498|||Mixed Models Analysis||Geometric mean ratio of C24 was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as a fixed-dose combination.||1.498|1.215|
71074463|NCT03660475|141658069|SUPERIORITY|||||||0.085|||||||t-test, 2 sided|||||||0.085
71074464|NCT03660475|141658071|SUPERIORITY|||||||0.903|||||||t-test, 2 sided|||||||0.903
71074465|NCT03660475|141658072|SUPERIORITY|||||||0.898|||||||t-test, 2 sided|||||||0.898
71074466|NCT03660475|141658073|SUPERIORITY|||||||0.221|||||||t-test, 2 sided|||||||0.221
71074467|NCT03660475|141658074|SUPERIORITY|||||||0.459|||||||t-test, 2 sided|||||||0.459
71074468|NCT00824382|141658081|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.091|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.051|0.131|||ANCOVA|||Olodaterol 2mcg - Placebo||0.131|0.051|<0.0001
71074469|NCT00824382|141658081|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.132|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.091|0.172|||ANCOVA|||Olodaterol 5mcg - Placebo||0.172|0.091|<0.0001
71074470|NCT00824382|141658081|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.132|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.092|0.172|||ANCOVA|||Olodaterol 10mcg - Placebo||0.172|0.092|<0.0001
71074471|NCT00824382|141658082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.021||0.0002||95.0|0.039|0.124|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.124|0.039|0.0002
71074472|NCT00824382|141658082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.098|0.184|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.184|0.098|<0.0001
71074473|NCT00824382|141658082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.115|0.199|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.199|0.115|<0.0001
71074474|NCT00824382|141658083|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.138|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.095|0.182|||ANCOVA|||Olodaterol 2mcg - Placebo||0.182|0.095|<0.0001
71074475|NCT00824382|141658083|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.197|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.154|0.241|||ANCOVA|||Olodaterol 5mcg - Placebo||0.241|0.154|<0.0001
71116016|NCT02589665|141738473|SUPERIORITY||Odds Ratio (OR)|6.54|||<|0.001|TWO_SIDED|95.0|2.81|15.2|||Regression, Logistic|||||15.20|2.81|<0.001
71116017|NCT02589665|141738473|SUPERIORITY||Odds Ratio (OR)|2.27||||0.054|TWO_SIDED|95.0|0.98|5.22|||Regression, Logistic|||||5.22|0.98|0.054
71116018|NCT02589665|141738474|SUPERIORITY||Odds Ratio (OR)|0.48||||0.131|TWO_SIDED|95.0|0.19|1.24|||Regression, Logistic|||||1.24|0.19|0.131
71116019|NCT02589665|141738475|SUPERIORITY||Odds Ratio (OR)|2.25||||0.215|TWO_SIDED|95.0|0.63|8.07|||Regression, Logistic|||||8.07|0.63|0.215
71116020|NCT02589665|141738475|SUPERIORITY||Odds Ratio (OR)|7.7|||<|0.001|TWO_SIDED|95.0|2.37|25.0|||Regression, Logistic|||||25.00|2.37|<0.001
71116021|NCT02589665|141738475|SUPERIORITY||Odds Ratio (OR)|4.62||||0.012|TWO_SIDED|95.0|1.41|15.14|||Regression, Logistic|||||15.14|1.41|0.012
71116022|NCT02589665|141738476|SUPERIORITY||Odds Ratio (OR)|0.71||||0.428|TWO_SIDED|95.0|0.31|1.65|||Regression, Logistic|||||1.65|0.31|0.428
71116023|NCT01519791|141738491|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.283|||<|0.001|TWO_SIDED|95.0|1.503|3.468|||Regression, Logistic||The Odds ratio measuring the treatment effect was estimated from a logistic regression model including terms for treatment, region and stratification factor. Nonresponder imputation (NRI) was used.|"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):~1. Primary: sustained DAS28(ESR) remission at Week 52~2. Key secondary: sustained DAS28(ESR) LDA at Week 52~3. ACR50 response at Week 52 in relation to Baseline~4. Change from Baseline in HAQ-DI at Week 52~5. Change from Baseline in mTSS at Week 52"||3.468|1.503|<0.001
71116024|NCT01519791|141738492|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.957|||<|0.001|TWO_SIDED|95.0|1.384|2.767|||Regression, Logistic||The Odds ratio measuring the treatment effect was estimated from a logistic regression model including terms for treatment, region and stratification factor. Nonresponder imputation (NRI) was used.|"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):~1. Primary: sustained DAS28(ESR) remission at Week 52~2. Key secondary: sustained DAS28(ESR) LDA at Week 52~3. ACR50 response at Week 52 in relation to Baseline~4. Change from Baseline in HAQ-DI at Week 52~5. Change from Baseline in mTSS at Week 52"||2.767|1.384|<0.001
71116025|NCT01519791|141738493|SUPERIORITY_OR_OTHER||Hodges-Lehmann point estimate of shift|-0.978|||<|0.001|TWO_SIDED|95.0|-1.005|-0.5|||ANCOVA on ranks||"ANCOVA model on the ranks with the terms for treatment, region, and time since RA diagnosis at Baseline (≤4 months or \>4 months) as factors and rank Baseline value as a covariate.~Confidence Interval is an asymptotic Moses CI."|"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):~1. Primary: sustained DAS28(ESR) remission at Week 52~2. Key secondary: sustained DAS28(ESR) LDA at Week 52~3. ACR50 response at Week 52 in relation to Baseline~4. Change from Baseline in HAQ-DI at Week 52~5. Change from Baseline in mTSS at Week 52"||-0.500|-1.005|<0.001
71116026|NCT01519791|141738498|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.446|||=|0.023|TWO_SIDED|95.0|1.052|1.989|||Regression, Logistic||The Odds ratio was estimated from a logistic regression model including terms for treatment, region and stratification factor. Nonresponder imputation (NRI) was used.|"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):~1. Primary: sustained DAS28(ESR) remission at Week 52~2. Key secondary: sustained DAS28(ESR) LDA at Week 52~3. ACR50 response at Week 52 in relation to Baseline~4. Change from Baseline in HAQ-DI at Week 52~5. Change from Baseline in mTSS at Week 52"||1.989|1.052|=0.023
71116027|NCT01519791|141738510|SUPERIORITY_OR_OTHER||Difference in Least Squares (LS) Means|-0.177|STANDARD_ERROR_OF_MEAN|0.049|<|0.001|TWO_SIDED|95.0|-0.273|-0.082|||ANCOVA||The CfB in HAQ-DI at Week 52 was analyzed using an ANCOVA model with terms for treatment, region, and time since Rheumatoid Arthritis (RA) diagnosis at Baseline (≤4 months or \>4 months) as factors and Baseline value as a covariate.|"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):~1. Primary: sustained DAS28(ESR) remission at Week 52~2. Key secondary: sustained DAS28(ESR) LDA at Week 52~3. ACR50 response at Week 52 in relation to Baseline~4. Change from Baseline in HAQ-DI at Week 52~5. Change from Baseline in mTSS at Week 52"||-0.082|-0.273|<0.001
71116028|NCT02226562|141738528|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1||||0.0001|TWO_SIDED|95.0|-1.28|-0.92||The P-value was less than 0.0001|ANCOVA|ANCOVA with a factor for treatment and baseline as covariate||||-0.92|-1.28|0.0001
71116029|NCT01474772|141738535|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.12||0.0659|TWO_SIDED|95.0|-0.46|0.01||Primary analysis was two-sided and performed at the 0.05 significance level. The study was considered positive only if both co-primary endpoints had p-values that were less than 0.05, hence there was no need for multiplicity adjustment.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline pain, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. Last observation carried forward (LOCF) approach was applied.||0.01|-0.46|0.0659
71116030|NCT01474772|141738536|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.291|STANDARD_ERROR_OF_MEAN|0.128||0.0242|TWO_SIDED|95.0|-0.543|-0.038||Primary analysis was two-sided and performed at the 0.05 significance level. Unstructured covariance structure was used to estimate the within-participant errors.|Repeated measure mixed effects model|The Kenward-Roger method was used to estimate denominator degrees of freedom.||This longitudinal analysis was a sensitivity analysis of the primary endpoint. P-value was based on a repeated measure mixed effects model including pooled center, time point, treatment, an indicator variable for Week 6 as well as interaction terms as fixed effect factors. For analysis purpose, it is assumed that participants were on placebo at Baseline, took the same treatment as in Period 1 during Week 1 of washout, and were on placebo in Week 2 of washout.||-0.038|-0.543|0.0242
71117708|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-66.43|||<|0.001|TWO_SIDED|95.0|-81.99|-50.88||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-50.88|-81.99|<0.001
71074476|NCT00824382|141658083|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.193|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.15|0.236|||ANCOVA|||Olodaterol 10mcg - Placebo||0.236|0.150|<0.0001
71074477|NCT00824382|141658084|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.146|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.101|0.191|||ANCOVA|||Olodaterol 2mcg - Placebo||0.191|0.101|<0.0001
71074478|NCT00824382|141658084|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.202|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.157|0.247|||ANCOVA|||Olodaterol 5mcg - Placebo||0.247|0.157|<0.0001
71074479|NCT00824382|141658084|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.196|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.151|0.24|||ANCOVA|||Olodaterol 10mcg - Placebo||0.240|0.151|<0.0001
71074480|NCT00824382|141658085|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.191|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001||95.0|0.107|0.275|||ANCOVA|||Olodaterol 2mcg - Placebo||0.275|0.107|<0.0001
71116031|NCT01474772|141738537|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.16||0.412|TWO_SIDED|95.0|-0.44|0.18||Primary analysis was two-sided and performed at the 0.05 significance level. The study was considered positive only if both co-primary endpoints have p-values that are less than 0.05, hence there was no need for multiplicity adjustment.|Mixed-Effect Model Repeated Measures|Satterthwaite's approximation was used to estimate denominator degrees of freedom.||Analysis was done using a repeated measure linear mixed effects model including baseline pain, sequence, period, center, time, treatment, and treatment by time interaction as fixed effect factors and participant within sequence and within-participant error as random factors. The model term 'time' may take 2 values corresponding to Week 3 and Week 6 in each period.||0.18|-0.44|0.4120
71116032|NCT01474772|141738538|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.0847|TWO_SIDED|95.0|0.94|2.55||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Generalized linear mixed model|||Analysis was done overall (period 1 and period 2) using a generalized linear mixed model which included response as the dependent variable, sequence, period, pooled center, treatment as fixed effects, and subject within treatment as random effect. LOCF approach was applied.||2.55|0.94|0.0847
71116033|NCT01474772|141738539|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.38||||0.2459|TWO_SIDED|95.0|0.8|2.39||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Generalized linear mixed model|||Analysis was done overall (period 1 and period 2) using a generalized linear mixed model which included response as the dependent variable, sequence, period, pooled center, treatment as fixed effects, and subject within treatment as random effect. LOCF approach was applied.||2.39|0.80|0.2459
71074481|NCT00824382|141658085|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.191|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001||95.0|0.106|0.276|||ANCOVA|||Olodaterol 5mcg - Placebo||0.276|0.106|<0.0001
71074482|NCT00824382|141658085|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.187|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001||95.0|0.103|0.27|||ANCOVA|||Olodaterol 10mcg - Placebo||0.270|0.103|<0.0001
71074483|NCT00824382|141658086|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.253|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001||95.0|0.16|0.345|||ANCOVA|||Olodaterol 2mcg - Placebo||0.345|0.160|<0.0001
71074484|NCT00824382|141658086|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.25|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001||95.0|0.156|0.343|||ANCOVA|||Olodaterol 5mcg - Placebo||0.343|0.156|<0.0001
71074485|NCT00824382|141658086|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.233|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001||95.0|0.141|0.325|||ANCOVA|||Olodaterol 10mcg - Placebo||0.325|0.141|<0.0001
71074486|NCT00824382|141658087|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.253|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.155|0.351|||ANCOVA|||Olodaterol 2mcg - Placebo||0.351|0.155|<0.0001
71074487|NCT00824382|141658087|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.242|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.142|0.341|||ANCOVA|||Olodaterol 5mcg - Placebo||0.341|0.142|<0.0001
71074488|NCT00824382|141658087|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.226|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.129|0.324|||ANCOVA|||Olodaterol 10mcg - Placebo||0.324|0.129|<0.0001
71074489|NCT00824382|141658088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.039||0.0045||95.0|0.035|0.188|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.188|0.035|0.0045
71074490|NCT00824382|141658088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.216|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.14|0.293|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.293|0.140|<0.0001
71074491|NCT00824382|141658088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.217|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.142|0.292|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.292|0.142|<0.0001
71074492|NCT00824382|141658089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.039||0.0348||95.0|0.006|0.159|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.159|0.006|0.0348
71074493|NCT00824382|141658089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.1|0.252|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.252|0.100|<0.0001
71074494|NCT00824382|141658089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.115|0.265|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.265|0.115|<0.0001
71074495|NCT00824382|141658090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.256|STANDARD_ERROR_OF_MEAN|5.476|<|0.0001||95.0|16.477|38.036|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||38.036|16.477|<0.0001
71116034|NCT01474772|141738540|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.46||0.0889|TWO_SIDED|95.0|-1.71|0.12||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline pain, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.12|-1.71|0.0889
71116035|NCT01474772|141738541|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|0.86||0.1781|TWO_SIDED|95.0|-2.86|0.53||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline pain, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.53|-2.86|0.1781
71074496|NCT00824382|141658090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.383|STANDARD_ERROR_OF_MEAN|5.574|<|0.0001||95.0|18.41|40.357|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||40.357|18.410|<0.0001
71074497|NCT00824382|141658090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.678|STANDARD_ERROR_OF_MEAN|5.431|<|0.0001||95.0|25.987|47.369|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||47.369|25.987|<0.0001
71074498|NCT00824382|141658091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.052|STANDARD_ERROR_OF_MEAN|5.534|<|0.0001||95.0|18.159|39.946|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||39.946|18.159|<0.0001
71074499|NCT00824382|141658091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.955|STANDARD_ERROR_OF_MEAN|5.635|<|0.0001||95.0|19.861|42.049|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||42.049|19.861|<0.0001
71074500|NCT00824382|141658091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.191|STANDARD_ERROR_OF_MEAN|5.489|<|0.0001||95.0|26.386|47.996|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||47.996|26.386|<0.0001
71074501|NCT00824382|141658092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.191|STANDARD_ERROR_OF_MEAN|0.149||0.2016||95.0|-0.485|0.103|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.103|-0.485|0.2016
71074502|NCT00824382|141658092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.454|STANDARD_ERROR_OF_MEAN|0.151||0.0029||95.0|-0.752|-0.156|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||-0.156|-0.752|0.0029
70940532|NCT01837719|141381196|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.144||||||90.0|1.006|1.3|||Mixed Models Analysis||Geometric mean ratio was calculated as Treatment D/Treatment C|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as an FDC||1.300|1.006|
70940533|NCT01837719|141381196|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.231|||||TWO_SIDED|90.0|1.023|1.483|||||Geometric mean ratio was calculated as Treatment E/Treatment D|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as a fixed-dose combination.||1.483|1.023|
70940534|NCT01837719|141381196|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.912||||||90.0|0.789|1.054|||Mixed Models Analysis||Geometric mean ratio was calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as a fixed-dose combination.||1.054|0.789|
71074503|NCT00824382|141658092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.387|STANDARD_ERROR_OF_MEAN|0.148||0.0095||95.0|-0.678|-0.095|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||-0.095|-0.678|0.0095
71074504|NCT00232596|141658111|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Non-parametric rank analysis of covariance adjusted for baseline 28-seizure frequency and stratified by baseline seizure frequency category and region|Non-parametric rank ANCOVA|||||||<0.001
71074505|NCT00232596|141658112|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71074506|NCT01253174|141658131|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|102.26||||||90.0|96.65|108.2||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Yasmin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 42 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||108.20|96.65|
71074507|NCT01253174|141658132|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|101.13||||||90.0|97.65|104.75||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Yasmin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 42 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||104.75|97.65|
71116036|NCT01474772|141738542|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.17||0.2719|TWO_SIDED|95.0|-0.53|0.15||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline pain, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.15|-0.53|0.2719
71074508|NCT01253174|141658133|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|98.66||||||90.0|93.37|104.24||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Yasmin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|39 volunteers qualified for statistical analysis of BE whereas all 40 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||104.24|93.37|
71074509|NCT01253174|141658134|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|99.45||||||90.0|96.7|102.28||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Yasmin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|39 volunteers qualified for statistical analysis of BE whereas all 40 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||102.28|96.70|
71074510|NCT01253174|141658135|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|106.19||||||90.0|99.18|113.68||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 41 (EE30/DRSP/L-5-MTHF Ca) and 43 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||113.68|99.18|
70940535|NCT01837719|141381198|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.023|||||TWO_SIDED|90.0|0.991|1.057|||||Geometric mean ratio was calculated as Treatment B/Treatment A|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when administered as a fixed-dose combination.||1.057|0.991|
70940536|NCT01837719|141381198|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.305|||||TWO_SIDED|90.0|1.215|1.402|||Mixed Models Analysis||Geometric mean ratio was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when administered as a fixed-dose combination.||1.402|1.215|
70940537|NCT01837719|141381198|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.085|||||TWO_SIDED|90.0|0.925|1.273|||||Geometric mean ratio was calculated as Treatment D/Treatment C|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir cobicistat||1.273|0.925|
71074511|NCT01253174|141658136|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|97.98||||||90.0|94.19|101.93||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 41 (EE30/DRSP/L-5-MTHF Ca) and 43 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||101.93|94.19|
71116037|NCT01474772|141738543|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|563.39|STANDARD_ERROR_OF_MEAN|4098.74||0.8909|TWO_SIDED|95.0|-7549.82|8676.6||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. LOCF approach was applied.||8676.60|-7549.82|0.8909
71116038|NCT01474772|141738544|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|206.37||0.9899|TWO_SIDED|95.0|-411.26|406.01||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. LOCF approach was applied.||406.01|-411.26|0.9899
70940538|NCT01837719|141381198|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.04|||||TWO_SIDED|90.0|0.937|1.154|||||Geometric mean ratio was calculated asTreatment E/Treatment D|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when administered as a fixed-dose combination.||1.154|0.937|
71078813|NCT01796301|141665657|SUPERIORITY||Treatment difference|3.2|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.5|3.9|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.||3.9|2.5|< 0.0001
70940539|NCT01837719|141381198|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.784|||||TWO_SIDED|90.0|0.717|0.858|||Mixed Models Analysis||Geometric mean ratio was calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when administered as a fixed-dose combination.||0.858|0.717|
71116039|NCT01474772|141738545|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|1.27||0.2854|TWO_SIDED|95.0|-3.88|1.15||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||1.15|-3.88|0.2854
71116040|NCT01474772|141738546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.46|STANDARD_ERROR_OF_MEAN|1.09||0.1805|TWO_SIDED|95.0|-3.6|0.68||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.68|-3.60|0.1805
71074512|NCT01253174|141658137|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|104.9||||||90.0|98.83|111.34||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 41 (EE30/DRSP/L-5-MTHF Ca) and 43 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||111.34|98.83|
71074513|NCT01253174|141658138|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|99.63||||||90.0|95.73|103.69||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 41 (EE30/DRSP/L-5-MTHF Ca) and 43 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||103.69|95.73|
71074514|NCT01253174|141658140|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|99.57||||||90.0|97.32|101.87||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Yasmin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|38 volunteers qualified for statistical analysis of BE whereas all 40 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||101.87|97.32|
71116041|NCT01474772|141738547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.33||0.3028|TWO_SIDED|95.0|-0.99|0.31||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.31|-0.99|0.3028
71116042|NCT01474772|141738548|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.18||0.7542|TWO_SIDED|95.0|-0.41|0.3||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.30|-0.41|0.7542
71116043|NCT01474772|141738549|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.27|STANDARD_ERROR_OF_MEAN|0.68||0.0634|TWO_SIDED|95.0|-2.62|0.07||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.07|-2.62|0.0634
71074515|NCT00224406|141658149|SUPERIORITY||Mean Difference (Final Values)|5.022||||0.8541|ONE_SIDED|95.0||50.26|||t-test, 1 sided|||Repeated Measurements Analysis of PaO2/FiO2 ratio corrected for the altitude at 0 and 24hours after ICU admission using a one-sided test excluding missing data. Herein analysis at ICU Admission (Time 0).||50.26||0.8541
71074516|NCT00224406|141658149|SUPERIORITY||Mean Difference (Final Values)|10.426||||0.6996|ONE_SIDED|95.0||55.17|||t-test, 1 sided|||Repeated Measurements Analysis of PaO2/FiO2 ratio corrected for the altitude at 0 and 24hours after ICU admission using a one-sided test excluding missing data. Herein analysis at 24 Hours Post ICU Admission.||55.17||0.6996
71116044|NCT01474772|141738550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.19||0.1985|TWO_SIDED|95.0|-0.13|0.62||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.62|-0.13|0.1985
70940540|NCT01837719|141381200|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.019|||||TWO_SIDED|90.0|0.983|1.057|||||Geometric mean ratio of AUC(0-T) was calculated as Treatment B/Treatment A|A linear mixed-effect model was applied to the natural logarithms of cobicistat AUC(0-T) with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect.||1.057|0.983|
70940541|NCT01837719|141381200|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.232||||||90.0|1.141|1.331|||||Geometric mean ratio of AUC(0-T) was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when given as an FDC||1.331|1.141|
70940542|NCT01837719|141381200|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.102|||||TWO_SIDED|90.0|0.929|1.307|||||Geometric mean ratio of AUC(0-T) was calculated as Treatment D/Treatment C|A linear mixed-effect model was applied to the natural logarithms of cobicistat AUC(0-T) with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect.||1.307|0.929|
70940543|NCT01837719|141381200|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.127||||||90.0|1.017|1.248|||||Geometric mean ratio of AUC(0-T) was calculated asTreatment E/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a high fat meal and the fasted state on the natural logarithms of exposure of cobicistat when given as an FDC.||1.248|1.017|
71074517|NCT00224406|141658150|SUPERIORITY||Mean Difference (Final Values)|4.377||||0.8654|ONE_SIDED|95.0||47.15|||t-test, 1 sided|||ICU Admission (Time 0)||47.15||0.8654
71074518|NCT00224406|141658150|SUPERIORITY||Median Difference (Final Values)|13.386||||0.6789|ONE_SIDED|95.0||66.91|||t-test, 1 sided|||24 Hours Post ICU Admission||66.91||0.6789
71074519|NCT00224406|141658150|SUPERIORITY||Mean Difference (Final Values)|-19.968||||0.6345|ONE_SIDED|95.0||49.56|||t-test, 1 sided|||48 Hours Post ICU Admission||49.56||0.6345
71074520|NCT00224406|141658150|SUPERIORITY||Mean Difference (Final Values)|0.908||||0.9858|ONE_SIDED|95.0||85.49|||t-test, 1 sided|||72 Hours Post ICU Admission||85.49||0.9858
71074521|NCT00224406|141658151|SUPERIORITY||Odds Ratio (OR)|2.867||||0.7985|TWO_SIDED|95.0|0.727|11.302|||Cochran-Mantel-Haenszel||Odds ratio is Repertaxin:Placebo ratio of PGD scores 0-2:PGD score 3 odds|Analysis of PGD score was performed separately at time 0, and at 24, 48, 72 hours after ICU admission. Herein analysis at ICU Admission (Time 0). One patient of placebo group is excluded from analysis of PGD score because the cause of graft dysfunction is Cardiogenic pulmonary edema.||11.302|0.727|0.7985
71074522|NCT00224406|141658151|SUPERIORITY||Odds Ratio (OR)|0.837||||0.5606|TWO_SIDED|95.0|0.226|3.092|||Cochran-Mantel-Haenszel||Odds ratio is Repertaxin:Placebo ratio of PGD scores 0-2:PGD score 3 odds|Analysis of PGD score was performed separately at time 0, and at 24, 48, 72 hours after ICU admission. Herein analysis at 24h post-ICU admission. One patient of placebo group is excluded from analysis of PGD score because the cause of graft dysfunction is Cardiogenic pulmonary edema.||3.092|0.226|0.5606
71074523|NCT00224406|141658151|SUPERIORITY||Odds Ratio (OR)|1.716||||0.8786|TWO_SIDED|95.0|0.531|5.552|||Cochran-Mantel-Haenszel||Odds ratio is Repertaxin:Placebo ratio of PGD scores 0-2:PGD score 3 odds|Analysis of PGD score was performed separately at time 0, and at 24, 48, 72 hours after ICU admission. Herein analysis at 48h post-ICU admission. One patient of placebo group is excluded from analysis of PGD score because the cause of graft dysfunction is Cardiogenic pulmonary edema.||5.552|0.531|0.8786
71074524|NCT00224406|141658151|SUPERIORITY||Odds Ratio (OR)|1.337||||0.8499|TWO_SIDED|95.0|0.352|5.072|||Cochran-Mantel-Haenszel||Odds ratio is Repertaxin:Placebo ratio of PGD scores 0-2:PGD score 3 odds|Analysis of PGD score was performed separately at time 0, and at 24, 48, 72 hours after ICU admission. Herein analysis at 72h post-ICU admission. One patient of placebo group is excluded from analysis of PGD score because the cause of graft dysfunction is Cardiogenic pulmonary edema.||5.072|0.352|0.8499
71074525|NCT00224406|141658152|SUPERIORITY|at 24 hrs from mechanical ventilation|difference in event probability|0.0091||||0.7076|TWO_SIDED|95.0|-0.1867|0.2049|||Log Rank|||||0.2049|-0.1867|0.7076
71074526|NCT00224406|141658152|SUPERIORITY||difference in event probability|-0.0316||||0.7076|TWO_SIDED|95.0|-0.2092|0.146|||Log Rank|||at 48 hrs from mechanical ventilation||0.1460|-0.2092|0.7076
70940544|NCT01837719|141381200|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.89|||||TWO_SIDED|90.0|0.825|0.96|||||Geometric mean ratio of AUC(0-T) was calculated asTreatment E/Treatment B|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a high fat meal and a light meal on the natural logarithms of exposure of cobicistat when given as an FDC||0.960|0.825|
71074527|NCT00224406|141658152|SUPERIORITY||difference in event probability|-0.0661||||0.7076|TWO_SIDED|95.0|-0.2314|0.0993|||Log Rank|||at 72 hrs from mechanical ventilation||0.0993|-0.2314|0.7076
71074528|NCT00224406|141658153|SUPERIORITY||Difference in event probability|-0.0364||||0.9632|TWO_SIDED|95.0|-0.0858|0.0131|||Log Rank|||Analysis at 24 hours||0.0131|-0.0858|0.9632
71074529|NCT00224406|141658153|SUPERIORITY||Difference in event probability|0.0352||||0.9632|TWO_SIDED|95.0|-0.1458|0.2162|||Log Rank|||Analysis at 48 h||0.2162|-0.1458|0.9632
71074530|NCT00224406|141658153|SUPERIORITY||Difference in event probability|-0.0179||||0.9632|TWO_SIDED|95.0|-0.2143|0.1785|||Log Rank|||analysis at 72 h||0.1785|-0.2143|0.9632
71074531|NCT00224406|141658158|SUPERIORITY||Difference in event probability|-0.0566||||0.0111|TWO_SIDED|95.0|-0.1188|0.0056|||Log Rank|||Herein analysis up to month 3 was reported.||0.0056|-0.1188|0.0111
71074532|NCT00224406|141658158|SUPERIORITY||Difference in event probability|-0.0943||||0.0111|TWO_SIDED|95.0|-0.173|-0.0156|||Log Rank|||Herein analysis up to month 6 was reported.||-0.0156|-0.1730|0.0111
71074533|NCT00224406|141658158|SUPERIORITY||Difference in event probability|-0.1132||||0.0111|TWO_SIDED|95.0|-0.1985|-0.0279|||Log Rank|||Herein analysis up to month 9 was reported.||-0.0279|-0.1985|0.0111
71074534|NCT00224406|141658158|SUPERIORITY||Slope|-0.1334||||0.0111|TWO_SIDED|95.0|-0.2254|-0.0413|||Log Rank|||Herein analysis up to month 12 was reported.||-0.0413|-0.2254|0.0111
70940545|NCT01837719|141381200|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% CI for the ratios of geometric means of the test formulation (FDC tablet of 300/150 mg atazanavir/cobicistat) to the reference formulation (300-mg atazanavir capsule coadministered with 150-mg cobicistat) were contained within 0.80 to 1.25 for atazanavir Cmax, AUC(0-T), and AUC(INF).|Geometric mean ratio|1.019|||||TWO_SIDED|90.0|0.982|1.058|||||Geometric mean ratio of AUC(INF) was calculated as Treatment B/Treatment A|To demonstrate bioequivalence for atazanavir between the test (Treatment B) and reference (Treatment A) formulations, a linear mixed-effects model was applied to the natural logarithms of atazanavir AUC(0-INF), with treatment, period, and sequence as fixed effects, and participant (sequence) as a random effect.||1.058|0.982|
70940546|NCT01837719|141381200|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.24|||||TWO_SIDED|90.0|1.148|1.34|||||Geometric mean ratio of AUC(INF) was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when given as an FDC||1.340|1.148|
71074535|NCT01556997|141658161|SUPERIORITY_OR_OTHER|||||||0.025|ONE_SIDED|||||The statistical model was an analysis of covariance model with treatment as the main effect and baseline DBP (\<100 mmHg versus ≥100 mmHg), current type 2 diabetes status (yes versus no), and race (black versus non-black) as covariates.|ANCOVA|||||||0.025
71074536|NCT01556997|141658162|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED|||||The statistical model was an analysis of covariance model with treatment as the main effect and baseline DBP (\<100 mmHg versus ≥100 mmHg), current type 2 diabetes status (yes versus no), and race (black versus non-black) as covariates.|ANCOVA|||||||0.025
71116045|NCT01474772|141738551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.9686|TWO_SIDED|95.0|-0.21|0.2||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.20|-0.21|0.9686
71116046|NCT01474772|141738552|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.54||||0.002|TWO_SIDED|95.0|1.3|4.95|||Cochran-Mantel-Haenszel|||Odds ratio is based on the binary response for any improvement while p-value is from the comparison of the original scale of 7 possible outcomes. P-value was calculated by using Cochran Mantel-Haenszel (CMH) test. PGIC values at the end of Period 1 data was compared between treatment groups.||4.95|1.30|0.0020
71116047|NCT01474772|141738553|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.15||0.0105|TWO_SIDED|95.0|-0.68|-0.09||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. LOCF approach was applied.||-0.09|-0.68|0.0105
71116048|NCT01474772|141738554|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.18||0.1178|TWO_SIDED|95.0|-0.63|0.07||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.07|-0.63|0.1178
71116049|NCT01474772|141738555|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.18||0.199|TWO_SIDED|95.0|-0.6|0.13||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.13|-0.60|0.1990
71116050|NCT01474772|141738556|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.02||0.71107|TWO_SIDED|95.0|-0.025|0.037||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Statistical analysis presented above is for the Index score Dolan 1997. Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.037|-0.025|0.71107
71074537|NCT01172808|141658163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.236|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.181|0.291|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.291|0.181|<0.0001
71074538|NCT01172808|141658163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.142|0.253|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre , week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.253|0.142|<0.0001
71074539|NCT01172808|141658164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.126|0.244|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.244|0.126|<0.0001
71116051|NCT01474772|141738556|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.009|STANDARD_ERROR_OF_MEAN|0.02||0.53965|TWO_SIDED|95.0|-0.021|0.039||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Statistical analysis presented above is for the Index score Dolan 2001. Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.039|-0.021|0.53965
70940547|NCT01837719|141381200|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.976|||||TWO_SIDED|90.0|0.886|1.075|||||Geometric mean ratio of AUC(INF) was calculated as Treatment D/Treatment C|A linear mixed-effect model was applied to the natural logarithms of cobicistat AUC(INF) with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect.||1.075|0.886|
70940548|NCT01837719|141381200|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.116|||||TWO_SIDED|90.0|1.012|1.231|||||Geometric mean ratio of AUC(INF) was calculated as Treatment E/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a high fat meal and fasted on the natural logarithms of exposure of cobicistat when given as an FDC.||1.231|1.012|
71074540|NCT01172808|141658164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.092|0.211|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction.||0.211|0.092|<0.0001
71074541|NCT01172808|141658165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.114|0.233|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.233|0.114|<0.0001
71074542|NCT01172808|141658165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.031||0.0008|TWO_SIDED|95.0|0.042|0.162|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model. Spatial power used as covariance structure. The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||0.162|0.042|0.0008
71074543|NCT01172808|141658166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.032||0.0001|TWO_SIDED|95.0|0.062|0.189|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.189|0.062|0.0001
71116052|NCT02731820|141738561|OTHER|||||||0.172|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T3 vs T0||||0.172
71116053|NCT02731820|141738561|OTHER|||||||0.027|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0||||0.027
71116054|NCT02731820|141738561|OTHER|||||||0.053|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3||||0.053
71116055|NCT02731820|141738561|OTHER|||||||0.002|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T3 vs T0||||0.002
71116056|NCT02731820|141738561|OTHER|||||||0.006|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T0||||0.006
71074544|NCT01172808|141658166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.076|STANDARD_ERROR_OF_MEAN|0.033||0.02|TWO_SIDED|95.0|0.012|0.14|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.140|0.012|0.0200
71116057|NCT02731820|141738561|OTHER|||||||0.139|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T3||||0.139
71116058|NCT02731820|141738561|OTHER|||||||0.967|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T0||||0.967
71116059|NCT02731820|141738561|OTHER|||||||0.446|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T3||||0.446
71116060|NCT02731820|141738561|OTHER|||||||0.869|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T6||||0.869
71116061|NCT02731820|141738562|OTHER|||||||0.954|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T3 vs T0||||0.954
70940549|NCT01837719|141381200|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.904|||||TWO_SIDED|90.0|0.836|0.978|||||Geometric mean ratio of AUC(INF) was calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a high fat meal and light meal on the natural logarithms of exposure of atazanavir when given as an FDC||0.978|0.836|
70940550|NCT02995733|141381208|SUPERIORITY|Asthma exacerbation rates during follow-up between two randomized treatment arms are compared using the Andersen-Gill adaptation of time-to-event Cox proportional hazard model with robust standard errors to account for multiple occurrences of the outcome in each patient (Andersen Gill, 1982). This analysis is based on intention-to-treat (ITT) patient population.|Cox Proportional Hazard|0.85||||0.048|TWO_SIDED|95.0|0.72|0.999|||Cox proportional hazard model|Pre-specified baseline covariates are adjusted in the model. A time-dependent covariate for the COVID pandemic is also included in adjustments.||||0.999|0.720|0.048
71116062|NCT02731820|141738562|OTHER|||||||0.798|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0||||0.798
71116063|NCT02731820|141738562|OTHER|||||||0.377|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3||||0.377
71116064|NCT02731820|141738562|OTHER|||||||0.886|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T3 vs T0||||0.886
71116065|NCT02731820|141738562|OTHER|||||||0.04|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T0||||0.040
71116066|NCT02731820|141738562|OTHER|||||||0.017|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T3||||0.017
70940551|NCT02995733|141381209|SUPERIORITY|Mixed model is used to compare the treatment effects. The response variable is ACT change at each monthly assessment from baseline. The covariates (included as fixed effects) include randomized treatment arm, continuous time of assessment as a linear and quadratic term and the interactions of the treatment arm with the time variables. Independent random effects include intercept and time variables. The model adjusts for all the baseline covariates included in the primary analysis.|Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0|0.5|1.2||||||||1.2|0.5|
71116067|NCT02731820|141738562|OTHER|||||||0.343|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T0||||0.343
71116068|NCT02731820|141738562|OTHER|||||||0.859|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T3||||0.859
71116069|NCT02731820|141738562|OTHER|||||||0.172|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T6||||0.172
71116070|NCT02731820|141738563|OTHER|||||||0.213|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T3 vs T0||||0.213
71116071|NCT02731820|141738563|OTHER|||||||0.191|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0||||0.191
71116072|NCT02731820|141738563|OTHER|||||||0.234|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3||||0.234
71116073|NCT02731820|141738563|OTHER|||||||0.37|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T3 vs T0||||0.370
71116074|NCT02731820|141738563|OTHER|||||||0.176|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T0||||0.176
71116075|NCT02731820|141738563|OTHER|||||||0.139|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T3||||0.139
71116076|NCT02731820|141738563|OTHER|||||||0.551|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T0||||0.551
71116077|NCT02731820|141738563|OTHER|||||||0.371|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T3||||0.371
71116078|NCT02731820|141738563|OTHER|||||||0.466|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T6||||0.466
71116079|NCT02731820|141738564|OTHER|||||||0.094|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T3 vs T0||||0.094
71116080|NCT02731820|141738564|OTHER|||||||0.0004|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0||||0.0004
71116081|NCT02731820|141738564|OTHER|||||||0.008|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3||||0.008
71116082|NCT02731820|141738564|OTHER|||||||0.002|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T3 vs T0||||0.002
71116083|NCT02731820|141738564|OTHER||||||<|0.0001|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0||||<0.0001
71116084|NCT02731820|141738564|OTHER|||||||0.0007|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3||||0.0007
71116085|NCT02731820|141738564|OTHER|||||||0.458|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T0||||0.458
71116086|NCT02731820|141738564|OTHER|||||||0.434|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T3||||0.434
71116087|NCT02731820|141738564|OTHER|||||||0.555|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T6||||0.555
71116088|NCT00967694|141738565|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Mixed Models Analysis|||A linear mixed effects model was used to assess change in IOP over time using time-points as the primary independent variable with significance set at p \< 0.05. Power calculations showed that 20 subjects would allow detection of a 2.8-mmHg difference in IOP between any two time-points with 80% power assuming a standard deviation of 3.5 mmHg for IOP and a correlation between two time- points of 0.25||||>0.05
71116089|NCT00152477|141738567|SUPERIORITY||Difference of response rate|6.4|||=|0.384|TWO_SIDED|95.0|-7.7|20.5||Two-sided Chi-square test. Fisher's Exact test presented when number of responders in a treatment group is \<5.|Cochran-Mantel-Haenszel|||||20.5|-7.7|=0.384
71116090|NCT00152477|141738567|SUPERIORITY||Difference of response rate|6.4|||=|0.409||95.0|-7.7|20.5||CMH test stratified by country and disease stage (3 levels: Stage IIIb without malignant pleural effusion versus Stage IIIb with malignant pleural effusion or Stage IV or recurrent).|Cochran-Mantel-Haenszel|||||20.5|-7.7|=0.409
71116091|NCT00152477|141738567|SUPERIORITY||Difference of response rate|2.6|||=|0.744|TWO_SIDED|95.0|-13.5|18.8||Two-sided Chi-square test. Fisher's Exact test presented when number of responders in a treatment group is \< 5.|Chi-squared|||||18.8|-13.5|=0.744
71116092|NCT00152477|141738567|SUPERIORITY||Difference of response rate|2.6|||=|0.783|TWO_SIDED|95.0|-13.5|18.8||CMH test stratified by country and disease stage (3 levels: Stage IIIb without malignant pleural effusion versus Stage IIIb with malignant pleural effusion or Stage IV or recurrent).|Cochran-Mantel-Haenszel|||||18.8|-13.5|=0.783
71116093|NCT00152477|141738567|SUPERIORITY||Difference of response rate|10.2|||=|0.234|TWO_SIDED|95.0|-6.8|27.2||Two-sided Chi-square test. Fisher's Exact test presented when number of responders in a treatment group is \< 5.|Chi-squared|||||27.2|-6.8|=0.234
71116094|NCT00152477|141738567|SUPERIORITY||Difference of response rate|10.2|||=|0.228|TWO_SIDED|95.0|-6.8|27.2||CMH test stratified by country and disease stage (3 levels: Stage IIIb without malignant pleural effusion versus Stage IIIb with malignant pleural effusion or Stage IV or recurrent).|Cochran-Mantel-Haenszel|||||27.2|-6.8|=0.228
70940552|NCT02995733|141381210|SUPERIORITY|Mixed model is used to compare the treatment effects. The response variable is ASUI change at each monthly assessment from baseline. The covariates (included as fixed effects) include randomized treatment arm, continuous time of assessment as a linear and quadratic term and the interactions of the treatment arm with the time variables. Independent random effects include intercept and time variables. The model adjusts for all the baseline covariates included in the primary analysis.|Mean Difference (Final Values)|0.04|||||TWO_SIDED|95.0|0.02|0.05||||||||0.05|0.02|
70940553|NCT02995733|141381211|SUPERIORITY|Negative binomial regression model is used, with time as an offset to account for differential duration of follow-up. The model adjusts for all the baseline covariates included in the primary analysis.|Rate ratio|0.8|||||TWO_SIDED|95.0|0.67|0.95||||||||0.95|0.67|
71074545|NCT01172808|141658167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.224|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.171|0.278|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.278|0.171|<0.0001
71074546|NCT01172808|141658167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.195|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.141|0.249|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.249|0.141|<0.0001
71074547|NCT01172808|141658168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001|TWO_SIDED|95.0|0.1|0.215|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.215|0.100|<0.0001
71074548|NCT01172808|141658168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.029||0.0003|TWO_SIDED|95.0|0.049|0.164|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.164|0.049|0.0003
71074549|NCT01172808|141658169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.907|STANDARD_ERROR_OF_MEAN|4.994|<|0.0001|TWO_SIDED|95.0|28.113|47.7|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||47.700|28.113|<0.0001
71074550|NCT01172808|141658169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.677|STANDARD_ERROR_OF_MEAN|5.023|<|0.0001|TWO_SIDED|95.0|23.825|43.529|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||43.529|23.825|<0.0001
71074551|NCT01172808|141658170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.066||0.2717|TWO_SIDED|95.0|-0.057|0.203|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.203|-0.057|0.2717
71074552|NCT01172808|141658170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.067||0.2956|TWO_SIDED|95.0|-0.061|0.201|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.201|-0.061|0.2956
71074553|NCT01172808|141658171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.202|STANDARD_ERROR_OF_MEAN|0.059||0.0007|TWO_SIDED|95.0|-0.318|-0.085|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||-0.085|-0.318|0.0007
71074554|NCT01172808|141658171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.133|STANDARD_ERROR_OF_MEAN|0.06||0.0262|TWO_SIDED|95.0|-0.25|-0.016|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||-0.016|-0.250|0.0262
71074555|NCT01172808|141658172|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.0377|TWO_SIDED|95.0|1.02|2.11||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R2.5 / Placebo|||2.11|1.02|0.0377
71074556|NCT01172808|141658172|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.76||||0.0022|TWO_SIDED|95.0|1.22|2.54||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|||2.54|1.22|0.0022
71116095|NCT01467037|141738593|SUPERIORITY_OR_OTHER||Adjusted OR|0.088|||||TWO_SIDED|95.0|0.02|0.384|||||Conditional logistic regression was used. Adjusted VE = (1 - adjusted OR) \*100|||0.384|0.020|
71116096|NCT01467037|141738593|SUPERIORITY_OR_OTHER||Adjusted OR|0.075|||||TWO_SIDED|95.0|0.018|0.307|||||Conditional logistic regression was used. Adjusted VE = (1 - adjusted OR) \*100|||0.307|0.018|
71074557|NCT01172808|141658173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.591|STANDARD_ERROR_OF_MEAN|4.52|<|0.0001|TWO_SIDED|95.0|21.726|39.455|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||39.455|21.726|<0.0001
71074558|NCT01172808|141658173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.66|STANDARD_ERROR_OF_MEAN|4.533|<|0.0001|TWO_SIDED|95.0|14.772|32.549|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||32.549|14.772|<0.0001
71074559|NCT01172808|141658174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.16|STANDARD_ERROR_OF_MEAN|4.447|<|0.0001|TWO_SIDED|95.0|19.44|36.88|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||36.880|19.440|<0.0001
71074560|NCT01172808|141658174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.37|STANDARD_ERROR_OF_MEAN|4.462|<|0.0001|TWO_SIDED|95.0|15.619|33.12|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||33.120|15.619|<0.0001
71074561|NCT01172808|141658175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.558|STANDARD_ERROR_OF_MEAN|0.603||0.355|TWO_SIDED|95.0|-1.74|0.624|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.624|-1.740|0.3550
71074562|NCT01172808|141658175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.58|STANDARD_ERROR_OF_MEAN|0.608||0.0094|TWO_SIDED|95.0|0.388|2.771|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||2.771|0.388|0.0094
71074563|NCT01172808|141658176|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.03||0.0069|TWO_SIDED|95.0|0.022|0.139|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.139|0.022|0.0069
70940554|NCT04879823|141381219|SUPERIORITY|||||||0.03|||||||t-test, 1 sided|||Null hypothesis: Average pain scores before medication will not be lower in the dexamethasone group compared with the placebo group.||||0.03
71074564|NCT01172808|141658176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|STANDARD_ERROR_OF_MEAN|0.03||0.081|TWO_SIDED|95.0|-0.006|0.111|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.111|-0.006|0.0810
71074565|NCT01172808|141658177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.031||0.0363|TWO_SIDED|95.0|0.004|0.126|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.126|0.004|0.0363
71074566|NCT01172808|141658177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|STANDARD_ERROR_OF_MEAN|0.031||0.2077|TWO_SIDED|95.0|-0.022|0.1|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.100|-0.022|0.2077
71074567|NCT01172808|141658178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.162|STANDARD_ERROR_OF_MEAN|0.14||0.2447|TWO_SIDED|95.0|-0.436|0.111|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.111|-0.436|0.2447
71074568|NCT01172808|141658178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.14||0.3046|TWO_SIDED|95.0|-0.131|0.419|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.419|-0.131|0.3046
71116097|NCT01194089|141738594|SUPERIORITY_OR_OTHER|||||||0.828|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for the postoperative opioid use during the postanesthesia care unit (PACU) stay, using a one tailed P value.||||0.828
71116098|NCT01194089|141738594|SUPERIORITY_OR_OTHER|||||||0.752|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the arms for the first 24 hours postoperatively, using a one tailed P value.||||0.752
70940555|NCT04879823|141381220|SUPERIORITY|||||||0.07|||||||Fisher Exact|||Null hypothesis: There will be no difference in the proportion of patients visiting the emergency department or urgent care (at least 1 time) post-operatively between dexamethasone and placebo groups.||||0.07
70940556|NCT04879823|141381221|SUPERIORITY|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: Average pain scores after medication will not be lower in the dexamethasone group compared with the placebo group.||||0.98
71074569|NCT01172808|141658179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.029||0.1178|TWO_SIDED|95.0|-0.011|0.102|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.102|-0.011|0.1178
71074570|NCT01172808|141658179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.029||0.888|TWO_SIDED|95.0|-0.061|0.053|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.053|-0.061|0.8880
71074571|NCT01172808|141658180|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.0308|TWO_SIDED|95.0|1.03|1.72||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R2.5 / Placebo|||1.72|1.03|0.0308
71074572|NCT01172808|141658180|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.0348|TWO_SIDED|95.0|1.02|1.71||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|||1.71|1.02|0.0348
71074573|NCT01010009|141658185|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Data was analysed by omnibus ANOVA with a priori planned comparisons utilizing the mean squares error term from this ANOVA.||||>0.05
71116099|NCT01194089|141738595|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Chi-squared|||Comparison between the arms for antiemetic medication use in the PACU.||||0.002
70940557|NCT03897075|141381235|SUPERIORITY|||||||0.00311|||||||Cochran-Mantel-Haenszel|||||||0.00311
70940558|NCT03897075|141381236|SUPERIORITY|||||||0.00079|||||||Cochran-Mantel-Haenszel|||||||0.00079
70940559|NCT03897075|141381237|SUPERIORITY|||||||0.09892|||||||Cochran-Mantel-Haenszel|||||||0.09892
70940560|NCT04468633|141381246|OTHER|||||||0.687|||||||t-test, 2 sided|||Baseline||||0.687
70940561|NCT04468633|141381246|OTHER|||||||0.384|||||||t-test, 2 sided|||Day 1||||0.384
70940562|NCT04468633|141381246|OTHER|||||||0.597|||||||t-test, 2 sided|||Week 1||||0.597
71074574|NCT01010009|141658185|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||Data was analysed by omnibus ANOVA with a priori planned comparisons utilizing the mean squares error term from this ANOVA.||||<0.05
71074575|NCT01010009|141658186|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Performance on each cognitive task was assessed via omnibus ANOVA with a priori planned comparisons.||||>0.05
71074576|NCT01010009|141658186|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Performance on each cognitive task was assessed via omnibus ANOVA with a priori planned comparisons.||||>0.05
71074577|NCT01010009|141658187|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||An omnibus ANOVA was carried out with a priori planned comparisons using the mean squares error term from this ANOVA.||||<0.05
71074578|NCT01010009|141658187|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||An omnibus ANOVA was carried out with a priori planned comparisons using the mean squares error term from this ANOVA.||||<0.05
71074579|NCT05070468|141658237|SUPERIORITY|||||||0.618|||||||Wilcoxon (Mann-Whitney)|||||||0.618
71074580|NCT05070468|141658238|SUPERIORITY|||||||0.483|||||||Wilcoxon (Mann-Whitney)|||||||0.483
71074581|NCT05070468|141658239|SUPERIORITY|||||||0.571|||||||Wilcoxon (Mann-Whitney)|||||||0.571
71074582|NCT02607280|141658240|OTHER||LS mean change from baseline at Week 14|-1.79|||||TWO_SIDED|95.0|-2.45|-1.14||||||||-1.14|-2.45|
71074583|NCT02607280|141658240|OTHER||LS mean change from baseline at Week 14|-2.07|||||TWO_SIDED|95.0|-3.77|-0.36||||||||-0.36|-3.77|
71074584|NCT01004432|141658241|SUPERIORITY_OR_OTHER||Percentage achive ACR 20 response|34.9|||<|0.0001|TWO_SIDED|95.0|30.4|39.4||One sided test adjusting for conducting one interim analysis|Chi-squared|||null hypothesis: proportion \<=0.2||39.4|30.4|<0.0001
71074585|NCT02696434|141658285|SUPERIORITY||Odds Ratio (OR)|0.68||||0.407|TWO_SIDED|95.0|0.28|1.68|||Regression, Logistic|||||1.68|0.28|0.407
71074586|NCT02539134|141658296|SUPERIORITY_OR_OTHER||Slope|1.06||||0.757|TWO_SIDED|90.0|0.741|1.374|||Power model|||Day 1: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 1 was assessed using the power model. For Day 1, the criteria for dose proportionality was the 90 percent (%) confidence interval (CI) for the slope within (0.875, 1.125) for the dose range of 100 mg to 600 mg.||1.374|0.741|0.757
71074587|NCT02539134|141658296|SUPERIORITY_OR_OTHER||Slope|1.37||||0.042|TWO_SIDED|90.0|1.078|1.664|||Power model|||Day 14: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 14 was assessed using the power model. For Day 14, the criteria for dose proportionality was the 90% CI for the slope within (0.839, 1.161) for the dose range of 100 mg to 400 mg.||1.664|1.078|0.042
71074588|NCT02539134|141658297|SUPERIORITY_OR_OTHER||Slope|1.2||||0.191|TWO_SIDED|90.0|0.946|1.45|||Power model|||Day 1: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 1 was assessed using the power model. For Day 1, the criteria for dose proportionality was the 90% CI for the slope within (0.875, 1.125) for the dose range of 100 mg to 600 mg.||1.450|0.946|0.191
71116100|NCT01194089|141738596|SUPERIORITY_OR_OTHER|||||||0.354|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The arms were compared for numeric pain score on admission.||||0.354
71116101|NCT01194089|141738596|SUPERIORITY_OR_OTHER|||||||0.492|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The arms were compared for numeric pain score at 30 minutes.||||0.492
71116102|NCT01194089|141738596|SUPERIORITY_OR_OTHER|||||||0.809|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The arms were compared for numeric pain score at 60 minutes.||||0.809
70940563|NCT04468633|141381246|OTHER|||||||0.86|||||||t-test, 2 sided|||Week 4||||0.860
70940564|NCT04468633|141381246|OTHER|||||||0.032|||||||t-test, 2 sided|||Week 6||||0.032
70940565|NCT04468633|141381246|OTHER|||||||0.026|||||||t-test, 2 sided|||Month 3||||0.026
70940566|NCT04468633|141381246|OTHER|||||||0.172|||||||t-test, 2 sided|||Month 6||||0.172
70940567|NCT04468633|141381246|OTHER|||||||0.01|||||||t-test, 2 sided|||Year 1||||0.010
70940568|NCT04468633|141381250|OTHER|||||||0.759|||||||Wilcoxon rank sum test|||||||0.759
70940569|NCT04468633|141381251|OTHER|||||||0.603|||||||Wilcoxon rank sum test|||||||0.603
70940570|NCT04468633|141381260|OTHER|||||||0.833|||||||Wilcoxon rank sum test|||||||0.833
71074589|NCT02539134|141658297|SUPERIORITY_OR_OTHER||Slope|1.37||||0.036|TWO_SIDED|90.0|1.089|1.657|||Power model|||Day 14: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 14 was assessed using the power model. For Day 14, the criteria for dose proportionality was the 90% CI for the slope within (0.839, 1.161) for the dose range of 100 mg to 400 mg.||1.657|1.089|0.036
71074590|NCT02539134|141658298|SUPERIORITY_OR_OTHER||Slope|1.19||||0.288|TWO_SIDED|90.0|0.89|1.489|||Power model|||Day 1: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 1 was assessed using the power model. For Day 1, the criteria for dose proportionality was the 90% CI for the slope within (0.875, 1.125) for the dose range of 100 mg to 600 mg.||1.489|0.890|0.288
71074591|NCT02539134|141658299|SUPERIORITY_OR_OTHER||Slope|1.36||||0.039|TWO_SIDED|90.0|1.08|1.642|||Power model|||Day 14: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 14 was assessed using the power model. For Day 14, the criteria for dose proportionality was the 90% CI for the slope within (0.839, 1.161) for the dose range of 100 mg to 400 mg.||1.642|1.080|0.039
71074592|NCT01149421|141658300|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|-2.79|||<|0.001|TWO_SIDED|97.3|-4.58|-1.0||P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||-1.00|-4.58|<0.001
71074593|NCT01149421|141658300|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|-1.07|||<|0.001|TWO_SIDED|97.3|-2.83|0.68||P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||0.68|-2.83|<0.001
71074594|NCT01149421|141658300|SUPERIORITY_OR_OTHER||||||<|0.001||||||Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||<0.001
71074595|NCT01149421|141658300|SUPERIORITY_OR_OTHER|||||||0.149||||||Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.149
71074596|NCT01149421|141658301|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|-2.66|||<|0.001|TWO_SIDED|97.3|-4.53|-0.79||P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||-0.79|-4.53|<0.001
71074597|NCT01149421|141658301|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|-1.71|||<|0.001|TWO_SIDED|97.3|-3.54|0.12||P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||0.12|-3.54|<0.001
71074598|NCT01149421|141658301|SUPERIORITY_OR_OTHER|||||||0.002||||||Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.002
71074599|NCT01149421|141658301|SUPERIORITY_OR_OTHER|||||||0.36||||||Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.36
71116103|NCT01194089|141738596|SUPERIORITY_OR_OTHER|||||||0.381|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The arms were compared for numeric pain score at discharge.||||0.381
71116104|NCT01626118|141738597|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|317.612|STANDARD_ERROR_OF_MEAN|149.6694||0.034|TWO_SIDED|95.0|23.297|611.926|||ANCOVA|||The p value was obtained from an analysis of covariance (ANCOVA) model that included treatment effect as the factor and baseline pain intensity as the covariate. This was the primary analysis of the primary efficacy parameter.||611.926|23.297|0.034
71116105|NCT01626118|141738597|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|342.132|STANDARD_ERROR_OF_MEAN|150.0397||0.023|TWO_SIDED|95.0|47.09|637.175|||ANCOVA|||The p value was obtained from an analysis of covariance (ANCOVA) model that included treatment effect as the factor and baseline pain intensity as the covariate. This was the primary analysis of the primary efficacy parameter.||637.175|47.090|0.023
71116106|NCT01626118|141738597|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|61.972|STANDARD_ERROR_OF_MEAN|150.2717||0.68|TWO_SIDED|95.0|-233.527|357.471|||ANCOVA|||The p value was obtained from an analysis of covariance (ANCOVA) model that included treatment effect as the factor and baseline pain intensity as the covariate. This was the primary analysis of the primary efficacy parameter.||357.471|-233.527|0.680
71116107|NCT01626118|141738597|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|503.008|STANDARD_ERROR_OF_MEAN|102.3149|<|0.001|TWO_SIDED|95.0|301.93|704.086|||Mixed Models Analysis|||"The p value was obtained from a mixed-model repeated-measure (MMRM) model that used all available data from all subjects to derive an estimate of pain intensity scores for subjects following study withdrawal, rather than imputing a score for individual subjects. The MMRM analysis was a sensitivity analysis of the primary efficacy parameter."||704.086|301.930|<0.001
71116108|NCT01626118|141738597|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|511.357|STANDARD_ERROR_OF_MEAN|102.5851|<|0.001|TWO_SIDED|95.0|309.749|712.965|||Mixed Models Analysis|||"The p value was obtained from a mixed-model repeated-measure (MMRM) model that used all available data from all subjects to derive an estimate of pain intensity scores for subjects following study withdrawal, rather than imputing a score for individual subjects. The MMRM analysis was a sensitivity analysis of the primary efficacy parameter."||712.965|309.749|<0.001
71116109|NCT01626118|141738597|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|341.232|STANDARD_ERROR_OF_MEAN|102.7761|<|0.001|TWO_SIDED|95.0|139.249|543.215|||Mixed Models Analysis|||"The p value was obtained from a mixed-model repeated-measure (MMRM) model that used all available data from all subjects to derive an estimate of pain intensity scores for subjects following study withdrawal, rather than imputing a score for individual subjects. The MMRM analysis was a sensitivity analysis of the primary efficacy parameter."||543.215|139.249|<0.001
71116110|NCT01626118|141738598|SUPERIORITY_OR_OTHER|||||||0.191|||||||t-test, 2 sided|||||||0.191
71074600|NCT01149421|141658302|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|0.32|||<|0.001|TWO_SIDED|97.3|-0.8|1.43||Treatment comparison at 16 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||1.43|-0.80|<0.001
71074601|NCT01149421|141658302|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|0.42|||<|0.001|TWO_SIDED|97.3|-0.67|1.52||Treatment comparison at 16 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||1.52|-0.67|<0.001
71074602|NCT01149421|141658302|SUPERIORITY_OR_OTHER|||||||0.87||||||Treatment comparison at 16 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.870
71074603|NCT01149421|141658302|SUPERIORITY_OR_OTHER|||||||0.915||||||Treatment comparison at 16 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.915
71074604|NCT01149421|141658302|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|0.5|||<|0.001|TWO_SIDED|97.3|-0.68|1.68||Treatment comparison at 26 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||1.68|-0.68|<0.001
71074605|NCT01149421|141658302|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|0.16|||<|0.001|TWO_SIDED|97.3|-1.0|1.31||Treatment comparison at 26 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||1.31|-1.00|<0.001
71116111|NCT01626118|141738598|SUPERIORITY_OR_OTHER|||||||0.108|||||||t-test, 2 sided|||||||0.108
71074606|NCT01149421|141658302|SUPERIORITY_OR_OTHER|||||||0.929||||||Treatment comparison at 26 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.929
71074607|NCT01149421|141658302|SUPERIORITY_OR_OTHER|||||||0.776||||||Treatment comparison at 26 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.776
71074608|NCT01149421|141658303|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|2.84||||0.556|TWO_SIDED|97.3|1.52|4.16||Treatment comparison at 16 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||4.16|1.52|0.556
71074609|NCT01149421|141658303|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|1.62||||0.018|TWO_SIDED|97.3|0.32|2.92||Treatment comparison at 16 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||2.92|0.32|0.018
71074610|NCT01149421|141658303|SUPERIORITY_OR_OTHER|||||||1||||||Treatment comparison at 16 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||1.00
71074611|NCT01149421|141658303|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|3.5||||0.904|TWO_SIDED|97.3|2.1|4.91||Treatment comparison at 26 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||4.91|2.10|0.904
71074612|NCT01149421|141658303|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|1.26||||0.005|TWO_SIDED|97.3|-0.13|2.64||Treatment comparison at 26 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||2.64|-0.13|0.005
71074613|NCT01149421|141658303|SUPERIORITY_OR_OTHER|||||||0.996||||||Treatment comparison at 26 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.996
71074614|NCT01149421|141658304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.05|||<|0.001|TWO_SIDED|95.0|-4.0|-2.09||Treatment comparison at 16 weeks.|Mixed Models Analysis|||||-2.09|-4.00|<0.001
71074615|NCT01149421|141658304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.58||||0.001|TWO_SIDED|95.0|-2.51|-0.64||Treatment comparison at 16 weeks.|Mixed Models Analysis|||||-0.64|-2.51|0.001
71074616|NCT01149421|141658304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|||<|0.001|TWO_SIDED|95.0|-4.1|-2.09||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||-2.09|-4.10|<0.001
71116112|NCT01626118|141738598|SUPERIORITY_OR_OTHER|||||||0.461|||||||t-test, 2 sided|||||||0.461
71116113|NCT01626118|141738599|SUPERIORITY_OR_OTHER|||||||0.079|||||||t-test, 2 sided|||||||0.079
71116114|NCT01626118|141738599|SUPERIORITY_OR_OTHER|||||||0.041|||||||t-test, 2 sided|||||||0.041
71116115|NCT01626118|141738599|SUPERIORITY_OR_OTHER|||||||0.458|||||||t-test, 2 sided|||||||0.458
71116116|NCT01626118|141738600|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.020
71074617|NCT01149421|141658304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99|||<|0.001|TWO_SIDED|95.0|-2.98|-1.0||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||-1.00|-2.98|<0.001
71074618|NCT01149421|141658305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.218|TWO_SIDED|95.0|-1.84|0.42||Treatment comparison at 16 weeks.|Mixed Models Analysis|||||0.42|-1.84|0.218
71116117|NCT01626118|141738600|SUPERIORITY_OR_OTHER|||||||0.021|||||||t-test, 2 sided|||||||0.021
71116118|NCT01626118|141738600|SUPERIORITY_OR_OTHER|||||||0.441|||||||t-test, 2 sided|||||||0.441
71116119|NCT01626118|141738601|SUPERIORITY_OR_OTHER|||||||0.141|||||||t-test, 2 sided|||||||0.141
71116120|NCT01626118|141738601|SUPERIORITY_OR_OTHER|||||||0.071|||||||t-test, 2 sided|||||||0.071
70940571|NCT01403805|141381295|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Fisher's test 'Vaccine' versus 'Oral Care and Vaccines' and 'phumonia' and 'not pneumonia'|Fisher Exact|||The results were analyzed as means ± standard deviation (SD) or numbers (%). Differences between the 2 nursing homes were compared using Fisher's test.||||<0.001
70940572|NCT01403805|141381296|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Fisher Exact|||The results are expressed as means ± standard deviation (SD) or numbers (%). Differences between the 2 nursing homes were compared using Fisher's test.||||0.05
70940573|NCT03082196|141381301|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.037|TWO_SIDED|95.0|-1.9|-0.1|||t-test, 2 sided||The direction of the comparison (difference) is the test varnish to the standard varnish. A negative value for the difference indicates a lower caries increment in the test varnish as compared to the standard varnish.|||-0.1|-1.9|0.037
71074619|NCT01149421|141658305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.931|TWO_SIDED|95.0|-1.16|1.06||Treatment comparison at 16 weeks.|Mixed Models Analysis|||||1.06|-1.16|0.931
71074620|NCT01149421|141658305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.315|TWO_SIDED|95.0|-1.72|0.55||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||0.55|-1.72|0.315
71074621|NCT01149421|141658305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.465|TWO_SIDED|95.0|-1.54|0.7||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||0.70|-1.54|0.465
71074622|NCT01149421|141658306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.33|||<|0.001|TWO_SIDED|95.0|-5.04|-1.61||Treatment comparison of mean daytime systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis|||||-1.61|-5.04|<0.001
71074623|NCT01149421|141658306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.23||||0.153|TWO_SIDED|95.0|-2.91|0.46||Treatment comparison of mean daytime systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis|||||0.46|-2.91|0.153
71074624|NCT01149421|141658306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.87||||0.002|TWO_SIDED|95.0|-4.66|-1.09||Treatment comparison of mean daytime systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis|||||-1.09|-4.66|0.002
71074625|NCT01149421|141658306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.82||||0.042|TWO_SIDED|95.0|-3.57|-0.07||Treatment comparison of mean daytime systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis|||||-0.07|-3.57|0.042
70940574|NCT03082196|141381302|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.062|TWO_SIDED|95.0|-1.5|0.1|||t-test, 2 sided||The direction of the comparison (difference) is the test varnish to the standard varnish. A negative value for the difference indicates a lower caries increment in the test varnish as compared to the standard varnish.|||0.1|-1.5|0.062
70940575|NCT03082196|141381303|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.11|TWO_SIDED|95.0|-0.5|0.1|||t-test, 2 sided||"The direction of the comparison (difference) is the test varnish to the standard varnish. A negative value for the difference indicates a happier response in the test varnish as compared to the standard varnish."|||0.1|-0.5|0.11
70940576|NCT03082196|141381304|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.74|TWO_SIDED|95.0|-0.2|0.3|||t-test, 2 sided||"The direction of the comparison (difference) is the test varnish to the standard varnish. A positive value for the difference indicates an unhappier response in the test varnish as compared to the standard varnish."|||0.3|-0.2|0.74
71074626|NCT01149421|141658306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24||||0.221|TWO_SIDED|95.0|-3.23|0.75||Treatment comparison of mean nighttime systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis|||||0.75|-3.23|0.221
71074627|NCT01149421|141658306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.884|TWO_SIDED|95.0|-2.1|1.81||Treatment comparison of mean nighttime systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis|||||1.81|-2.10|0.884
71074628|NCT01149421|141658306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35||||0.19|TWO_SIDED|95.0|-4.31|-0.39||Treatment comparison of mean nighttime systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis|||||-0.39|-4.31|0.19
71074629|NCT01149421|141658306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38||||0.159|TWO_SIDED|95.0|-3.31|0.54||Treatment comparison of mean nighttime systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis|||||0.54|-3.31|0.159
71074630|NCT01149421|141658306|SUPERIORITY_OR_OTHER|||||||0.122||||||Treatment comparison of mean clinic systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis|||||||0.122
71074631|NCT01149421|141658306|SUPERIORITY_OR_OTHER|||||||0.601||||||Treatment comparison of mean clinic systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis|||||||0.601
71074632|NCT01149421|141658306|SUPERIORITY_OR_OTHER|||||||0.012||||||Treatment comparison of mean clinic systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis|||||||0.012
71074633|NCT01149421|141658306|SUPERIORITY_OR_OTHER|||||||0.274||||||Treatment comparison of mean clinic systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis|||||||0.274
71074634|NCT01149421|141658307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.717|TWO_SIDED|95.0|-0.91|1.32||Treatment comparison of mean daytime diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis|||||1.32|-0.91|0.717
71074635|NCT01149421|141658307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.427|TWO_SIDED|95.0|-0.65|1.54||Treatment comparison of mean daytime diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis|||||1.54|-0.65|0.427
71074636|NCT01149421|141658307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.3|TWO_SIDED|95.0|-0.53|1.73||Treatment comparison of mean daytime diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis|||||1.73|-0.53|0.300
71074637|NCT01149421|141658307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.788|TWO_SIDED|95.0|-0.96|1.26||Treatment comparison of mean daytime diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis|||||1.26|-0.96|0.788
71074638|NCT01149421|141658307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08||||0.098|TWO_SIDED|95.0|-0.2|2.37||Treatment comparison of mean nighttime diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis|||||2.37|-0.20|0.098
71074639|NCT01149421|141658307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82||||0.203|TWO_SIDED|95.0|-0.44|2.08||Treatment comparison of mean nighttime diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis|||||2.08|-0.44|0.203
71074640|NCT01149421|141658307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.493|TWO_SIDED|95.0|-0.88|1.82||Treatment comparison of mean nighttime diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis|||||1.82|-0.88|0.493
71074641|NCT01149421|141658307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.692|TWO_SIDED|95.0|-1.06|1.6||Treatment comparison of mean nighttime diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis|||||1.60|-1.06|0.692
70940577|NCT01695993|141381306|OTHER|Primary Analysis: The Primary Aim to determine whether acupressure bands provided with efficacy-enhancing supplementary material are more effective in controlling chemotherapy-induced nausea than acupressure bands provided with neutral supplementary material was examined using ANCOVA with Peak Nausea after the first chemotherapy as the response, Arm (Arms 2 and 3) as the factor and expectancy of acupressure bands as the covariate.|Mean Difference (Net)|0.03|STANDARD_DEVIATION|1.9||0.05|TWO_SIDED|||||Not adjusted|ANCOVA|||||||.05
70940578|NCT04057937|141381307|SUPERIORITY||Percentage Difference:Apremilast-Placebo|37.4||||0.0003|TWO_SIDED|95.0|18.6|56.1||Two-sided 0.10 significant level|Chi-squared||Confidence Intervals calculated using the Wald method (normal approximation).|||56.1|18.6|0.0003
71074642|NCT01149421|141658307|SUPERIORITY_OR_OTHER|||||||0.99||||||Treatment comparison of mean clinic diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis|||||||0.990
71074643|NCT01149421|141658307|SUPERIORITY_OR_OTHER|||||||0.173||||||Treatment comparison of mean clinic diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis|||||||0.173
71074644|NCT01149421|141658307|SUPERIORITY_OR_OTHER|||||||0.972||||||Treatment comparison of mean clinic diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis|||||||0.972
71074645|NCT01149421|141658307|SUPERIORITY_OR_OTHER|||||||0.904||||||Treatment comparison of mean clinic diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis|||||||0.904
71074646|NCT01149421|141658308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.49|||<|0.001|TWO_SIDED|95.0|1.17|3.8||Treatment comparison of mean daytime heart rate (HR) at 16 weeks.|Mixed Models Analysis|||||3.80|1.17|<0.001
71074647|NCT01149421|141658308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.15||||0.08|TWO_SIDED|95.0|-0.14|2.45||Treatment comparison of mean daytime heart rate (HR) at 16 weeks.|Mixed Models Analysis|||||2.45|-0.14|0.080
71116121|NCT01626118|141738601|SUPERIORITY_OR_OTHER|||||||0.716|||||||t-test, 2 sided|||||||0.716
70940579|NCT05319756|141381326|SUPERIORITY||Mean Difference (Final Values)|32.8|STANDARD_ERROR_OF_MEAN|4.0|<|0.0001|ONE_SIDED|95.0|26.1||||Mixed Models Analysis|||"The sensitivity and integrity of the study was validated by comparing the mean responses of oxycodone HCl, the positive control (C), to the placebo (P):~H0: μC - μP ≤ δ1 versus Ha: μC - μP \> δ1 where δ1 =15"|||26.1|<.0001
71074648|NCT01149421|141658308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.57|||<|0.001|TWO_SIDED|95.0|2.23|4.91||Treatment comparison of mean daytime heart rate (HR) at 26 weeks.|Mixed Models Analysis|||||4.91|2.23|<0.001
71074649|NCT01149421|141658308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92||||0.168|TWO_SIDED|95.0|-0.39|2.24||Treatment comparison of mean daytime heart rate (HR) at 26 weeks.|Mixed Models Analysis|||||2.24|-0.39|0.168
71074650|NCT01149421|141658308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.95|||<|0.001|TWO_SIDED|95.0|2.62|5.28||Treatment comparison of mean nighttime heart rate (HR) at 16 weeks.|Mixed Models Analysis|||||5.28|2.62|<0.001
71074651|NCT01149421|141658308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.78|||<|0.001|TWO_SIDED|95.0|1.47|4.09||Treatment comparison of mean nighttime heart rate (HR) at 16 weeks.|Mixed Models Analysis|||||4.09|1.47|<0.001
71074652|NCT01149421|141658308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.98|||<|0.001|TWO_SIDED|95.0|2.49|5.47||Treatment comparison of mean nighttime heart rate (HR) at 26 weeks.|Mixed Models Analysis|||||5.47|2.49|<0.001
71074653|NCT01149421|141658308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.24||||0.003|TWO_SIDED|95.0|0.78|3.7||Treatment comparison of mean nighttime heart rate (HR) at 26 weeks.|Mixed Models Analysis|||||3.70|0.78|0.003
71074654|NCT01149421|141658308|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of mean clinic heart rate (HR) at 16 weeks.|Mixed Models Analysis|||||||<0.001
71074655|NCT01149421|141658308|SUPERIORITY_OR_OTHER|||||||0.014||||||Treatment comparison of mean clinic heart rate (HR) at 16 weeks.|Mixed Models Analysis|||||||0.014
71074656|NCT01149421|141658308|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of mean clinic heart rate (HR) at 26 weeks.|Mixed Models Analysis|||||||<0.001
71074657|NCT01149421|141658308|SUPERIORITY_OR_OTHER|||||||0.005||||||Treatment comparison of mean clinic heart rate (HR) at 26 weeks.|Mixed Models Analysis|||||||0.005
71074658|NCT01149421|141658309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47|||<|0.001|TWO_SIDED|95.0|-4.5|-2.43||Treatment comparison of mean daytime pulse pressure (PP) at 16 weeks.|Mixed Models Analysis|||||-2.43|-4.50|<0.001
71074659|NCT01149421|141658309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.77|||<|0.001|TWO_SIDED|95.0|-2.79|-0.75||Treatment comparison of mean daytime pulse pressure (PP) at 16 weeks.|Mixed Models Analysis|||||-0.75|-2.79|<0.001
71074660|NCT01149421|141658309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4|||<|0.001|TWO_SIDED|95.0|-4.52|-2.28||Treatment comparison of mean daytime pulse pressure (PP) at 26 weeks.|Mixed Models Analysis|||||-2.28|-4.52|<0.001
71074661|NCT01149421|141658309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.13|||<|0.001|TWO_SIDED|95.0|-3.23|-1.03||Treatment comparison of mean daytime pulse pressure (PP) at 26 weeks.|Mixed Models Analysis|||||-1.03|-3.23|<0.001
71074662|NCT01149421|141658309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.25|||<|0.001|TWO_SIDED|95.0|-3.43|-1.07||Treatment comparison of mean nighttime pulse pressure (PP) at 16 weeks.|Mixed Models Analysis|||||-1.07|-3.43|<0.001
71074663|NCT01149421|141658309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93||||0.113|TWO_SIDED|95.0|-2.09|0.22||Treatment comparison of mean nighttime pulse pressure (PP) at 16 weeks.|Mixed Models Analysis|||||0.22|-2.09|0.113
71074664|NCT01149421|141658309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.74|||<|0.001|TWO_SIDED|95.0|-3.86|-1.62||Treatment comparison of mean nighttime pulse pressure (PP) at 26 weeks.|Mixed Models Analysis|||||-1.62|-3.86|<0.001
71074665|NCT01149421|141658309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.61||||0.004|TWO_SIDED|95.0|-2.72|-0.51||Treatment comparison of mean nighttime pulse pressure (PP) at 26 weeks.|Mixed Models Analysis|||||-0.51|-2.72|0.004
71074666|NCT01149421|141658310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97||||0.128|TWO_SIDED|95.0|-2.22|0.28||Treatment comparison of mean daytime mean arterial pressure (MAP) at 16 weeks.|Mixed Models Analysis|||||0.28|-2.22|0.128
71116122|NCT01626118|141738602|SUPERIORITY_OR_OTHER|||||||0.049|||||||t-test, 2 sided|||||||0.049
71116123|NCT01626118|141738602|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.020
71116124|NCT01626118|141738602|SUPERIORITY_OR_OTHER|||||||0.593|||||||t-test, 2 sided|||||||0.593
71116125|NCT01626118|141738603|SUPERIORITY_OR_OTHER|||||||0.021|||||||t-test, 2 sided|||||||0.021
70940580|NCT05319756|141381326|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|4.46||0.1041|ONE_SIDED|95.0||1.7|||Mixed Models Analysis|||"The primary analysis evaluated whether gabapentin plus oxycodone HCl (T) produced mean responses that showed abuse potential that was no higher than oxycodone HCl (C). The margin for showing no significant difference was defined as 20% of the difference between oxycodone HCl (C) and Placebo (P):~H0: μT - μC ≥ 0.2(μC - μP) versus Ha: μT - μC \<0.2(μC - μP)."||1.7||0.1041
70940581|NCT05319756|141381326|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|4.46||0.3373|ONE_SIDED|95.0||5.5|||Mixed Models Analysis|||"The primary analysis evaluated whether gabapentin plus oxycodone HCl (T) produced mean responses that showed abuse potential that was no higher than oxycodone HCl (C). The margin for showing no significant difference was defined as 20% of the difference between oxycodone HCl (C) and Placebo (P):~H0: μT - μC ≥ 0.2(μC - μP) versus Ha: μT - μC \<0.2(μC - μP)."||5.5||0.3373
70940582|NCT05319756|141381326|NON_INFERIORITY|Non-inferiority margin = 10|Mean Difference (Final Values)|-12.3|STANDARD_ERROR_OF_MEAN|3.63|<|0.0001|ONE_SIDED|95.0||-6.3|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (G) produced mean responses that show less abuse potential than oxycodone HCl (C) were:~H0: μC - μG ≤ 0.2(μC - 50) versus Ha: μC - μG \>0.2(μC - 50)"||-6.3||<.0001
70940583|NCT05319756|141381326|NON_INFERIORITY|Non-inferiority margin = 10|Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|3.64|<|0.0001|ONE_SIDED|95.0||-0.6|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (G) produced mean responses that show less abuse potential than oxycodone HCl (C) were:~H0: μC - μG ≤ 0.2(μC - 50) versus Ha: μC - μG \>0.2(μC - 50)"||-0.6||<0.0001
70940584|NCT05319756|141381326|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|4.0||0.0232|ONE_SIDED|95.0||9.6|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (G) produced mean responses that show abuse potential similar to placebo(P) were:~H0: μG - μP ≥ δ2 versus Ha: μG - μP \< δ2 where δ2 =11"||9.6||0.0232
70940585|NCT05319756|141381326|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|4.01||0.2767|ONE_SIDED|95.0||15.2|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (G) produced mean responses that show abuse potential similar to placebo(P) were:~H0: μG - μP ≥ δ2 versus Ha: μG - μP \< δ2 where δ2 =11."||15.2||0.2767
70940586|NCT05319756|141381328|OTHER||Mean Difference (Final Values)|267.1|STANDARD_ERROR_OF_MEAN|83.688||0.0016|TWO_SIDED|90.0|128.8|405.4|||Mixed Models Analysis|||||405.4|128.8|0.0016
70940587|NCT05319756|141381328|OTHER||Mean Difference (Final Values)|29.19|STANDARD_ERROR_OF_MEAN|83.688||0.7276|TWO_SIDED|90.0|-109.0|167.5|||Mixed Models Analysis|||||167.5|-109|0.7276
70940588|NCT05319756|141381328|OTHER||Mean Difference (Final Values)|50.41|STANDARD_ERROR_OF_MEAN|83.785||0.5481|TWO_SIDED|90.0|-88.0|188.9|||Mixed Models Analysis|||||188.9|-88.0|0.5481
70940589|NCT05319756|141381328|OTHER||Mean Difference (Final Values)|350.7|STANDARD_ERROR_OF_MEAN|84.023|<|0.0001|TWO_SIDED|90.0|211.8|489.5|||Mixed Models Analysis|||||489.5|211.8|<0.0001
70940590|NCT05319756|141381328|OTHER||Mean Difference (Final Values)|364.4|STANDARD_ERROR_OF_MEAN|83.785|<|0.0001|TWO_SIDED|90.0|225.9|502.8|||Mixed Models Analysis|||||502.8|225.9|<0.0001
70940591|NCT05319756|141381328|OTHER||Mean Difference (Final Values)|-238.0|STANDARD_ERROR_OF_MEAN|83.785||0.005|TWO_SIDED|90.0|-376.0|-99.4|||Mixed Models Analysis|||||-99.4|-376|0.0050
70940592|NCT05319756|141381328|OTHER||Mean Difference (Final Values)|-217.0|STANDARD_ERROR_OF_MEAN|84.023||0.0106|TWO_SIDED|90.0|-356.0|-77.8|||Mixed Models Analysis|||||-77.8|-356|0.0106
70940593|NCT05319756|141381328|OTHER||Mean Difference (Final Values)|83.6|STANDARD_ERROR_OF_MEAN|83.785||0.3196|TWO_SIDED|90.0|-54.9|222.1|||Mixed Models Analysis|||||222.1|-54.9|0.3196
70940594|NCT05319756|141381328|OTHER||Mean Difference (Final Values)|97.29|STANDARD_ERROR_OF_MEAN|83.688||0.2464|TWO_SIDED|90.0|-41.0|235.6|||Mixed Models Analysis|||||235.6|-41.0|0.2464
70940595|NCT05319756|141381334|OTHER||Mean Difference (Final Values)|64.67|STANDARD_ERROR_OF_MEAN|7.581|<|0.0001|TWO_SIDED|90.0|52.15|77.2|||Mixed Models Analysis|||||77.20|52.15|<.0001
71074667|NCT01149421|141658310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.883|TWO_SIDED|95.0|-1.32|1.13||Treatment comparison of mean daytime mean arterial pressure (MAP) at 16 weeks.|Mixed Models Analysis|||||1.13|-1.32|0.883
71074668|NCT01149421|141658310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.39|TWO_SIDED|95.0|-1.84|0.72||Treatment comparison of mean daytime mean arterial pressure (MAP) at 26 weeks.|Mixed Models Analysis|||||0.72|-1.84|0.390
71074669|NCT01149421|141658310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.463|TWO_SIDED|95.0|-1.72|0.79||Treatment comparison of mean daytime mean arterial pressure (MAP) at 26 weeks.|Mixed Models Analysis|||||0.79|-1.72|0.463
71074670|NCT01149421|141658310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.671|TWO_SIDED|95.0|-1.13|1.76||Treatment comparison of mean nighttime mean arterial pressure (MAP) at 16 weeks.|Mixed Models Analysis|||||1.76|-1.13|0.671
71074671|NCT01149421|141658310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.471|TWO_SIDED|95.0|-0.9|1.95||Treatment comparison of mean nighttime mean arterial pressure (MAP) at 16 weeks.|Mixed Models Analysis|||||1.95|-0.90|0.471
71074672|NCT01149421|141658310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.543|TWO_SIDED|95.0|-1.95|1.03||Treatment comparison of mean nighttime mean arterial pressure (MAP) at 26 weeks.|Mixed Models Analysis|||||1.03|-1.95|0.543
71074673|NCT01149421|141658310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.728|TWO_SIDED|95.0|-1.72|1.2||Treatment comparison of mean nighttime mean arterial pressure (MAP) at 26 weeks.|Mixed Models Analysis|||||1.20|-1.72|0.728
71074674|NCT01149421|141658323|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 16 weeks.|Mixed Models Analysis|||||||<0.001
71074675|NCT01149421|141658323|SUPERIORITY_OR_OTHER|||||||0.005||||||Treatment comparison at 16 weeks.|Mixed Models Analysis|||||||0.005
71074676|NCT01149421|141658323|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||||<0.001
71074677|NCT01149421|141658323|SUPERIORITY_OR_OTHER|||||||0.012||||||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||||0.012
71074678|NCT00766467|141658327|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.3
71116126|NCT01626118|141738603|SUPERIORITY_OR_OTHER|||||||0.012|||||||t-test, 2 sided|||||||0.012
71116127|NCT01626118|141738603|SUPERIORITY_OR_OTHER|||||||0.447|||||||t-test, 2 sided|||||||0.447
71116128|NCT01626118|141738604|SUPERIORITY_OR_OTHER|||||||0.036|||||||t-test, 2 sided|||||||0.036
71116129|NCT01626118|141738604|SUPERIORITY_OR_OTHER|||||||0.017|||||||t-test, 2 sided|||||||0.017
71116130|NCT01626118|141738604|SUPERIORITY_OR_OTHER|||||||0.577|||||||t-test, 2 sided|||||||0.577
71116131|NCT00939029|141738606|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.7||||0.05|TWO_SIDED|90.0|1.0|7.5||1 tailed p-value|Regression, Logistic|||||7.5|1.0|0.05
71116132|NCT00939029|141738607|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1||||0.014|TWO_SIDED|90.0|1.4|11.6||1 tailed|Regression, Logistic|||||11.6|1.4|0.014
71116133|NCT00939029|141738608|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.087|TWO_SIDED|90.0|0.8|6.0||1 tailed|Regression, Logistic|||||6.0|0.8|0.087
71116134|NCT01106651|141738637|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.069|<|0.001|TWO_SIDED|95.0|-0.708|-0.436|||ANCOVA|||||-0.436|-0.708|<0.001
71116135|NCT01106651|141738637|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.841|-0.566|||ANCOVA|||||-0.566|-0.841|<0.001
71116136|NCT01106651|141738638|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.96|||<|0.001||95.0|1.93|4.56|||Regression, Logistic|||||4.56|1.93|<0.001
71116137|NCT01106651|141738638|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.48|||<|0.001||95.0|2.89|6.95|||Regression, Logistic|||||6.95|2.89|<0.001
71116138|NCT01106651|141738639|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-25.5|STANDARD_ERROR_OF_MEAN|3.147|<|0.001|TWO_SIDED|95.0|-31.68|-19.32|||ANCOVA|||||-19.32|-31.68|<0.001
71074679|NCT00676572|141658331|SUPERIORITY||||||<|0.05||||||calculated p values|t-test, 2 sided|||||||<0.05
71074680|NCT00334802|141658375|SUPERIORITY_OR_OTHER|||||||0.169||95.0||||P-value for Dose Level 1 Responders (Complete Response + Partial Response)|t-test, 2 sided|||||||0.169
71074681|NCT00334802|141658375|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Dose Level 2 Responders (Complete Response + Partial Response)|t-test, 2 sided|||||||0.001
71074682|NCT05727306|141658437|SUPERIORITY||Odds Ratio (OR)|1.35|||||TWO_SIDED|95.0|1.25|1.46|||||Calculated as the odds of having a depressive episode in participants diagnosed of Alopecia Areata vs. participants without Alopecia Areata. Odds Ratio adjusted for sociodemographic, clinical characteristics and major comorbidities.|||1.46|1.25|
71074683|NCT05727306|141658438|SUPERIORITY||Odds Ratio (OR)|1.45|||||TWO_SIDED|95.0|1.32|1.58|||||Calculated as the odds of having recurrent depressive disorder in participants diagnosed of Alopecia Areata vs. participants without Alopecia Areata. Odds Ratio adjusted for sociodemographic, clinical characteristics and major comorbidities.|||1.58|1.32|
71074684|NCT05727306|141658439|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|1.3|1.51|||||Calculated as the odds of having anxiety in participants diagnosed of Alopecia Areata vs. participants without Alopecia Areata. Odds Ratio adjusted for sociodemographic, clinical characteristics and major comorbidities.|||1.51|1.30|
71074685|NCT05727306|141658440|OTHER||Incidence rate ratio (IRR)|1.42|||||TWO_SIDED|95.0|1.37|1.46|||||Calculated as the incidence rate of attending primary care in participants diagnosed of Alopecia Areata vs. participants without Alopecia Areata. Incidence rate ratio adjusted for sociodemographic, clinical characteristics and major comorbidities.|||1.46|1.37|
71074686|NCT05727306|141658441|OTHER||Hazard Ratio (HR)|8.26|||||TWO_SIDED|95.0|7.55|9.04|||||Calculated using Cox Proportional Hazard model.Reflects a comparison of incidence rates between participants diagnosed with Alopecia Areata (AA) and those without AA. Adjusted for sociodemographic,clinical characteristics and major comorbidities.|||9.04|7.55|
71074687|NCT05727306|141658442|OTHER||Hazard Ratio (HR)|1.36|||||TWO_SIDED|95.0|1.17|1.57|||||Calculated using Cox Proportional Hazard model.Reflects a comparison of incidence rates between participants diagnosed with Alopecia Areata (AA) and those without AA. Adjusted for sociodemographic,clinical characteristics and major comorbidities.|||1.57|1.17|
71074688|NCT05727306|141658443|OTHER||Hazard Ratio (HR)|1.46|||||TWO_SIDED|95.0|1.14|1.87|||||Calculated using Cox Proportional Hazard model.Reflects a comparison of incidence rates between participants diagnosed with Alopecia Areata (AA) and those without AA. Adjusted for sociodemographic,clinical characteristics and major comorbidities.|||1.87|1.14|
71074689|NCT05727306|141658444|OTHER||Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|1.38|1.61|||||Calculated using Cox Proportional Hazard model.Reflects a comparison of incidence rates between participants diagnosed with Alopecia Areata (AA) and those without AA. Adjusted for sociodemographic,clinical characteristics and major comorbidities.|||1.61|1.38|
71074690|NCT04877535|141658494|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.524|TWO_SIDED|95.0|-0.24|0.12|||t-test, 2 sided|||||0.12|-0.24|0.524
71116139|NCT01106651|141738639|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-27.7|STANDARD_ERROR_OF_MEAN|3.179|<|0.001|TWO_SIDED|95.0|-33.97|-21.49|||ANCOVA|||||-21.49|-33.97|<0.001
71116140|NCT01106651|141738640|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.8|-1.7|||ANCOVA|||||-1.7|-2.8|<0.001
71116141|NCT01106651|141738640|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.5|-2.4|||ANCOVA|||||-2.4|-3.5|<0.001
71116142|NCT01106651|141738641|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.59|STANDARD_ERROR_OF_MEAN|0.379|<|0.001|TWO_SIDED|95.0|-2.339|-0.842|||ANCOVA|||||-0.842|-2.339|<0.001
71116143|NCT01106651|141738641|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.371|<|0.001|TWO_SIDED|95.0|-2.833|-1.368|||ANCOVA|||||-1.368|-2.833|<0.001
71116144|NCT01106651|141738642|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.305|<|0.001|TWO_SIDED|95.0|-1.633|-0.428|||ANCOVA|||Region percent total fat||-0.428|-1.633|<0.001
71116145|NCT01106651|141738642|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.772|-0.587|||ANCOVA|||Region percent total fat||-0.587|-1.772|<0.001
71116146|NCT01106651|141738643|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.316||0.001|TWO_SIDED|95.0|-1.677|-0.43|||ANCOVA|||||-0.430|-1.677|0.001
71116147|NCT01106651|141738643|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.311|<|0.001|TWO_SIDED|95.0|-1.812|-0.584|||ANCOVA|||||-0.584|-1.812|<0.001
71116148|NCT01106651|141738644|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-4.63|STANDARD_ERROR_OF_MEAN|1.134|<|0.001|TWO_SIDED|95.0|-6.854|-2.401|||ANCOVA|||||-2.401|-6.854|<0.001
71116149|NCT01106651|141738644|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-7.89|STANDARD_ERROR_OF_MEAN|1.147|<|0.001|TWO_SIDED|95.0|-10.14|-5.641|||ANCOVA|||||-5.641|-10.14|<0.001
71116150|NCT01106651|141738645|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|3.7||0.194|TWO_SIDED|95.0|-12.1|2.5|||ANCOVA|||||2.5|-12.1|0.194
71116151|NCT01106651|141738645|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|3.7||0.846|TWO_SIDED|95.0|-6.6|8.1|||ANCOVA|||||8.1|-6.6|0.846
71116152|NCT01106651|141738646|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|95.0|2.6|7.9|||ANCOVA|||||7.9|2.6|<0.001
71116153|NCT01106651|141738646|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|95.0|2.0|7.4|||ANCOVA|||||7.4|2.0|<0.001
71116154|NCT01106651|141738647|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.4|0.8|||ANCOVA|||||0.8|-0.4|
71116155|NCT01106651|141738647|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.9|0.3|||ANCOVA|||||0.3|-0.9|
71116156|NCT01106651|141738648|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.9|0.4|||ANCOVA|||||0.4|-0.9|
71116157|NCT01106651|141738648|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-1.0|0.3|||ANCOVA|||||0.3|-1.0|
71116158|NCT01106651|141738649|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.3|1.0|||ANCOVA|||||1.0|-0.3|
71116159|NCT01106651|141738649|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.3|1.1|||ANCOVA|||||1.1|-0.3|
71116160|NCT01106651|141738650|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||||-0.0|-0.8|
71116161|NCT01106651|141738650|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.9|-0.1|||ANCOVA|||||-0.1|-0.9|
71116162|NCT03641716|141738697|OTHER||Mean Difference (Net)|3.67|STANDARD_DEVIATION|2.08|||TWO_SIDED|||||||||||||
71116163|NCT03641716|141738698|OTHER||Effect Size - Cohen's d|-0.01|||||TWO_SIDED|95.0|-0.66|0.65||||||Due to limited size of sub-sample, we calculated a Cohen's d effect size for raw total score on the PSI from baseline to the 3-month follow-up, with a 95% confidence interval.||.65|-.66|
71116164|NCT03641716|141738699|OTHER||||||<|0.01||||||a prior threshold for statistical significance set at p\<.05|t-test, 2 sided|We ran a paired samples t-test with pre/post intervention data (from baseline and 3-month assessments).||After examining the data to ensure it met the statistical assumptions (e.g. normality, no outliers), we ran a paired-sample pre-post t-test to examine the difference in scores from baseline to 3 months on the NutriSTEP (Screening Tool for Every Preschooler) assessment.||||<.01
71116165|NCT02487654|141738700|SUPERIORITY||||||<|0.05|||||||Log Rank|||||||<0.05
71116166|NCT03268954|141738759|SUPERIORITY||Hazard Ratio (HR)|0.968|||=|0.557|TWO_SIDED|95.0|0.757|1.238|||Log Rank|P-value comparing EFS between treatment groups was based on the 1-sided Cui-Hung-Wang weighted unstratified log-rank test.|HR:unadjusted stratified Cox proportional hazard regression with stratification(low-blast AML,IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1:better prevention of EFS in combination arm than azacitidine arm.|||1.238|0.757|=0.557
71116167|NCT03268954|141738760|SUPERIORITY|P-value comparing OS between treatment groups was based on the 1-sided Cui-Hung-Wang weighted unstratified log-rank test.|Hazard Ratio (HR)|0.881|||=|0.181|TWO_SIDED|95.0|0.697|1.115|||Log Rank||HR:unadjusted stratified Cox proportional hazard regression with stratification(low-blast AML,IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1: longer survival time in combination arm than azacitidine arm.|Overall Survival (OS)||1.115|0.697|=0.181
71116168|NCT03268954|141738765|SUPERIORITY||Hazard Ratio (HR)|1.037|||=|0.562|TWO_SIDED|95.0|0.66|1.63||P-value comparing time to AML Transformation between treatment groups was based on 1-sided stratified log-rank test stratified by IPSS-R risk groups of very high, high, or intermediate for HR MDS.|Log Rank||HR:unadjusted stratified Cox proportional HazardRegression with stratification(IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1:better prevention of AML transformation in combination arm than azacitidine arm.|Time to AML Transformation in HR MDS Participants||1.630|0.660|=0.562
71116169|NCT03268954|141738765|SUPERIORITY||Hazard Ratio (HR)|1.512|||=|0.603|TWO_SIDED|95.0|0.068|33.773||P-value comparing time to AML Transformation between treatment groups was based on 1-sided stratified log-rank test stratified by IPSS-R risk groups of very high, high, or intermediate for HR CMML.|Log Rank||HR:unadjusted stratified Cox proportional HazardRegression with stratification(IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1:better prevention of AML transformation in combination arm than azacitidine arm.|Time to AML Transformation in HR CMML Participants||33.773|0.068|=0.603
71116170|NCT03268954|141738765|SUPERIORITY||Hazard Ratio (HR)|1.034|||=|0.558|TWO_SIDED|95.0|0.663|1.61||P-value comparing time to AML Transformation between treatment groups was based on 1-sided stratified log-rank test stratified by IPSS-R risk groups of very high, high, or intermediate for HR CMML/MDS.|Log Rank||HR:unadjusted stratified Cox proportional HazardRegression with stratification(IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1:better prevention of AML transformation in combination arm than azacitidine arm.|Time to AML Transformation in HR MDS/CMML Participants||1.610|0.663|=0.558
71116171|NCT03268954|141738766|SUPERIORITY||Absolute Rate Difference|-4.18|||=|0.374|TWO_SIDED|95.0|-13.18|4.83||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Cochran-Mantel-Haenszel|||Number of Participants With Complete Remission (CR) and CR+Complete Remission with Incomplete Blood Count Recovery (CRi)||4.83|-13.18|=0.374
71074691|NCT04877535|141658494|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.403|TWO_SIDED|95.0|-0.4|0.16|||t-test, 2 sided|||||0.16|-0.4|0.403
71116172|NCT03268954|141738771|SUPERIORITY||Absolute Rate Difference|-4.67|||=|0.329|TWO_SIDED|95.0|-13.72|4.39||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test stratified by low-blast AML, Revised International Prognostic Scoring System (IPSS-R) risk groups of very high, high, or intermediate for HR MDS/CMML.|Cochran-Mantel-Haenszel|||Number of Participants with OR||4.39|-13.72|=0.329
71116173|NCT03268954|141738772|SUPERIORITY||Absolute Rate Difference|-0.44|||=|0.891|TWO_SIDED|95.0|-10.03|9.15||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Cochran-Mantel-Haenszel|||Number of Participants with OR2||9.15|-10.03|=0.891
71116174|NCT03268954|141738773|SUPERIORITY||Hazard Ratio (HR)|0.679|||=|0.072|TWO_SIDED|95.0|0.402|1.146|||Log Rank|P-value was based on 1-sided log-rank test stratified by low-blast AML,IPSS-R risk groups of very high,high,or intermediate for HR MDS/CMML.|Hazard ratio was based on an unadjusted stratified Cox proportional hazard regression model with stratification factors (low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML) and treatment as a factor in the model.|Duration of CR||1.146|0.402|=0.072
71116175|NCT03268954|141738774|SUPERIORITY||Hazard Ratio (HR)|0.846|||=|0.373|TWO_SIDED|95.0|0.306|2.339||P-value comparing duration of CR+CRi between treatment groups was based on 1-sided unstratified log-rank.|Log Rank||Hazard ratio was based on an unadjusted unstratified Cox proportional hazard regression model with treatment as a factor in the model.|Duration of Complete Remission + Complete Remission with Incomplete Blood Count Recovery (CRi)||2.339|0.306|=0.373
71074692|NCT04877535|141658495|SUPERIORITY||Odds Ratio (OR)|1.05||||1|TWO_SIDED|95.0|0.47|2.38|||Fisher Exact|||||2.38|0.47|1.00
71074693|NCT04877535|141658496|SUPERIORITY||Odds Ratio (OR)|4.3|||<|0.001|TWO_SIDED|95.0|1.81|11.13|||Fisher Exact|||||11.13|1.81|<0.001
71074694|NCT04877535|141658496|SUPERIORITY||Odds Ratio (OR)|1.08||||1|TWO_SIDED|95.0|0.23|4.19|||Fisher Exact|||||4.19|0.23|1.00
71074695|NCT04877535|141658497|SUPERIORITY||Odds Ratio (OR)|7.1|||<|0.001|TWO_SIDED|95.0|1.94|39.25|||Fisher Exact|||||39.25|1.94|<0.001
71074696|NCT04877535|141658497|SUPERIORITY||Odds Ratio (OR)|1.63||||0.63|TWO_SIDED|95.0|0.13|14.86|||Fisher Exact|||||14.86|0.13|0.630
71074697|NCT05079230|141658523|SUPERIORITY||Hazard Ratio (HR)|1.178||||0.3276|TWO_SIDED|95.0|0.848|1.637|||stratified log-rank test|The 2-sided P-value was based on stratified log-rank test, stratified by stratification factors at randomization.|Stratified hazard ratio (HR) and its 95% CI were calculated using the stratified cox proportional hazards model.|||1.637|0.848|0.3276
71074698|NCT05079230|141658524|SUPERIORITY||Stratified Odds Ratio|0.826||||0.3616|TWO_SIDED|95.0|0.545|1.251|||Stratum-adjusted Mantel-Haenszel||Stratified odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for stratification factors.|||1.251|0.545|0.3616
71074699|NCT05079230|141658525|SUPERIORITY||Stratified Odds Ratio|0.856||||0.4679|TWO_SIDED|95.0|0.56|1.307|||Stratum-adjusted Mantel-Haenszel||Stratified odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for stratification factors.|||1.307|0.560|0.4679
71074700|NCT05079230|141658526|SUPERIORITY||Stratified Hazard Ratio|0.946||||0.7903|TWO_SIDED|95.0|0.73|1.225|||Stratified Log Rank||The 2-sided P-value was based on stratified log-rank test, stratified by stratification factors at randomization.|||1.225|0.730|0.7903
71074701|NCT05079230|141658529|SUPERIORITY||Stratified Odds Ratio|1.189||||0.4873|TWO_SIDED|95.0|0.727|1.945|||Stratum-adjusted Mantel Haenszel||Stratified odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for stratification factors.|||1.945|0.727|0.4873
71074702|NCT05079230|141658530|SUPERIORITY||Stratified Odds Ratio|1.154||||0.5842|TWO_SIDED|95.0|0.69|1.932|||Stratum-adjusted Mantel Haenszel||Stratified odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for stratification factors.|||1.932|0.690|0.5842
71074703|NCT05079230|141658531|SUPERIORITY||Stratified Odds Ratio|0.783||||0.3003|TWO_SIDED|95.0|0.492|1.245|||Cochran-Mantel-Haenszel||The 2-sided P-value was based on Cochran-Mantel-Haenszel (CMH) method stratified by the stratification factors at randomization (age, genetic risk group, and geographic region).|||1.245|0.492|0.3003
71074704|NCT05079230|141658532|SUPERIORITY||Stratified Odds Ratio|1.21||||0.579|TWO_SIDED|95.0|0.62|2.36||The 2-sided P-value was based on Cochran-Mantel-Haenszel (CMH) method stratified by the stratification factors at randomization (age, genetic risk group, and geographic region).|Cochran-Mantel-Haenszel|||||2.360|0.620|0.5790
71074705|NCT05079230|141658533|SUPERIORITY||Stratified Hazard Ratio|1.09||||0.5796|TWO_SIDED|95.0|0.799|1.487|||Stratified Log Rank|The 2-sided P-value was based on stratified log-rank test, stratified by stratification factors at randomization.|Stratified hazard ratio (HR) and its 95% CI are calculated using the stratified cox proportional hazards model.|||1.487|0.799|0.5796
71074706|NCT05079230|141658534|SUPERIORITY||Stratified Hazard Ratio|1.271||||0.1026|TWO_SIDED|95.0|0.948|1.704|||Stratified Log Rank|The 2-sided P-value was based on stratified log-rank test, stratified by stratification factors at randomization.|Stratified hazard ratio (HR) and its 95% CI were calculated using the stratified cox proportional hazards model.|||1.704|0.948|0.1026
71074707|NCT01362244|141658549|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0|||||Fisher Exact|||Statistical data is presented for NR||||0.003
71074708|NCT01362244|141658549|SUPERIORITY_OR_OTHER_LEGACY|||||||0.016||95.0|||||Fisher Exact|||Statistical data is presented for LOCF||||0.016
71074709|NCT01362244|141658550|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.74||||0.71|TWO_SIDED|95.0|0.15|3.64|||Regression, Logistic||Week 1|||3.64|0.15|0.710
71074710|NCT01362244|141658550|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.4||||0.674|TWO_SIDED|95.0|0.29|6.87|||Regression, Logistic||Week 2|||6.87|0.29|0.674
71074711|NCT01362244|141658550|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.94||||0.942|TWO_SIDED|95.0|0.2|4.49|||Regression, Logistic||Week 5|||4.49|0.20|0.942
71074712|NCT01362244|141658550|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.9||||0.091|TWO_SIDED|95.0|0.8|18.96|||Regression, Logistic||Week 9|||18.96|0.80|0.091
71116176|NCT03268954|141738775|SUPERIORITY||Hazard Ratio (HR)|0.889|||=|0.32|TWO_SIDED|95.0|0.542|1.458||P-value comparing duration of PR or better response between treatment groups was based on 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||Hazard ratio was based on an unadjusted stratified Cox proportional hazard regression model with stratification factors (low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML) and treatment as a factor in the model.|Duration of Overall Response (OR)||1.458|0.542|=0.320
71116177|NCT03268954|141738776|SUPERIORITY||Hazard Ratio (HR)|0.796|||=|0.151|TWO_SIDED|95.0|0.514|1.231||P-value comparing duration of overall response 2 between treatment groups was based on 1-sided log-rank test stratified by low blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||Hazard ratio was based on an unadjusted stratified Cox proportional hazard regression model with stratification factors (low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML) and treatment as a factor in the model.|Duration of Overall Response 2 (OR2)||1.231|0.514|=0.151
71074713|NCT01362244|141658550|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|11.66||||0.004|TWO_SIDED|95.0|2.18|62.33|||Regression, Logistic||Week 13|||62.33|2.18|0.004
71116178|NCT03268954|141738777|SUPERIORITY||Absolute Rate Difference|3.27|||=|0.573|TWO_SIDED|95.0|-9.02|15.55||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel|||Percentage of Participants With RBC-transfusion Independence||15.55|-9.02|=0.573
71116179|NCT03268954|141738777|SUPERIORITY||Absolute Rate Difference|-3.43|||=|0.477|TWO_SIDED|95.0|-25.84|18.97||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel|||Percentage of Participants With Platelet-transfusion Independence||18.97|-25.84|=0.477
71116180|NCT03268954|141738778|SUPERIORITY||Hazard Ratio (HR)|1.231|||=|0.774|TWO_SIDED|95.0|0.715|2.119||P-value comparing duration of RBC or platelet transfusion between treatment groups was based on 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||HR:unadjusted Cox Proportional Hazard regression;stratification(low-blast AML,IPSS-R risk groups=very high,high,intermediate for HRMDS/CMML),treatment as factor.HR\<1:longer duration of transfusion independence in combination arm than azacitidine arm.|Duration of RBC Transfusion Independence||2.119|0.715|=0.774
71116181|NCT03268954|141738778|SUPERIORITY||Hazard Ratio (HR)|1.533|||=|0.801|TWO_SIDED|95.0|0.567|4.147||P-value comparing duration of platelet transfusion between treatment groups was based on 1-sided log-rank test stratified by low blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||HR:unadjusted Cox Proportional Hazard regression;stratification(low-blast AML,IPSS-R risk groups=very high,high,intermediate for HRMDS/CMML),treatment as factor.HR\<1:longer duration of transfusion independence in combination arm than azacitidine arm.|Duration of Platelet Transfusion Independence||4.147|0.567|=0.801
71116182|NCT03268954|141738778|SUPERIORITY||Hazard Ratio (HR)|0.968|||=|0.45|TWO_SIDED|95.0|0.58|1.614||P-value comparing duration of RBC or platelet transfusion between treatment groups was based on 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||HR:unadjusted Cox Proportional Hazard regression;stratification(low-blast AML,IPSS-R risk groups=very high,high,intermediate for HRMDS/CMML),treatment as factor.HR\<1:longer duration of transfusion independence in combination arm than azacitidine arm.|Duration of Transfusion Independence||1.614|0.580|=0.450
71116183|NCT03268954|141738779|SUPERIORITY||Hazard Ratio (HR)|0.88|||=|0.228|TWO_SIDED|95.0|0.628|1.234||P-value comparing time to first CR or PR or CRi (low-blast AML) between treatment groups was based on 1-sided stratified log-rank test stratified by low-blast AML,IPSS-R risk groups of very high,high,or intermediate for HR MDS/CMML.|Log Rank||Hazard ratio was based on an unadjusted stratified Cox proportional hazard regression model with stratification factors (low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML) and treatment as a factor in the model.|Time to First Complete Remission (CR) or Partial Remission (PR) or Complete Remission with Incomplete Blood Count Recovery (CRi)||1.234|0.628|=0.228
71116184|NCT03268954|141738780|SUPERIORITY||Absolute Rate Difference|-5.46|||=|0.32|TWO_SIDED|95.0|-16.36|5.44||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel|||Number of Participants With HI||5.44|-16.36|=0.320
71116185|NCT03268954|141738781|SUPERIORITY||Rate Difference|2.64|||||TWO_SIDED|95.0|-0.3|5.58||||||Number of Participants With at Least 1 Inpatient Hospital Admissions Related to HR MDS, CMML or Low-blast AML||5.58|-0.30|
71116186|NCT03268954|141738782|SUPERIORITY||Hazard Ratio (HR)|0.858|||=|0.084|TWO_SIDED|95.0|0.689|1.067||P-value was obtained from a stratified 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||Hazard ratio was based on a stratified Cox proportional hazard regression model stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML, with treatment as a factor in the model.|Time to Progressive Disease (PD), Relapse after CR (Low-blast AML), Relapse After CR or PR (HR MDS/CMML), or Death||1.067|0.689|=0.084
71116187|NCT03268954|141738783|SUPERIORITY||Hazard Ratio (HR)|0.75|||=|0.002|TWO_SIDED|95.0|0.615|0.913|||Log Rank|||||0.913|0.615|=0.002
71116188|NCT03268954|141738785|SUPERIORITY||Absolute Rate Difference|-2.85|||=|0.683|TWO_SIDED|95.0|-19.44|13.75||P-value for HR MDS/CMML was obtained from a stratified Cochran-Mantel-Haenszel chi-square test|Cochran-Mantel-Haenszel|||OR: HR MDS/CMML Participants||13.75|-19.44|=0.683
71116189|NCT03268954|141738785|SUPERIORITY||Absolute Rate Difference|2.36|||=|0.84|TWO_SIDED|95.0|-20.39|25.12||P-value for Low-blast AML was obtained from an unstratified Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel|||ORR: Low-blast AML Participants||25.12|-20.39|=0.840
71074714|NCT01362244|141658550|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.74||||0.224|TWO_SIDED|95.0|0.54|13.9|||Regression, Logistic||Week 17|||13.90|0.54|0.224
71074715|NCT01362244|141658550|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.85||||0.037|TWO_SIDED|95.0|1.11|30.69|||Regression, Logistic||Week 21|||30.69|1.11|0.037
71074716|NCT01362244|141658550|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.22||||0.051|TWO_SIDED|95.0|0.99|27.44|||Regression, Logistic||Week 25|||27.44|0.99|0.051
71074717|NCT01362244|141658567|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04||||0.567|TWO_SIDED|95.0|-0.1|0.19|||repeated measures model||Week 2|||0.19|-0.10|0.567
71074718|NCT01362244|141658567|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05||||0.495|TWO_SIDED|95.0|-0.1|0.21|||repeated measures model||Week 5|||0.21|-0.10|0.495
70940596|NCT05319756|141381334|OTHER||Mean Difference (Final Values)|14.66|STANDARD_ERROR_OF_MEAN|7.581||0.0546|TWO_SIDED|90.0|2.13|27.1|||Mixed Models Analysis|||||27.1|2.13|0.0546
70940597|NCT05319756|141381334|OTHER||Mean Difference (Final Values)|11.58|STANDARD_ERROR_OF_MEAN|7.589||0.1286|TWO_SIDED|90.0|-0.96|24.12|||Mixed Models Analysis|||||24.12|-0.96|0.1286
70940598|NCT05319756|141381334|OTHER||Mean Difference (Final Values)|68.99|STANDARD_ERROR_OF_MEAN|7.611|<|0.0001|TWO_SIDED|90.0|56.42|81.57|||Mixed Models Analysis|||||81.57|56.42|<.0001
70940599|NCT05319756|141381334|OTHER||Mean Difference (Final Values)|76.37|STANDARD_ERROR_OF_MEAN|7.589|<|0.0001|TWO_SIDED|90.0|63.83|88.91|||Mixed Models Analysis|||||88.91|63.83|<.0001
70940600|NCT05319756|141381334|OTHER||Mean Difference (Final Values)|-50.0|STANDARD_ERROR_OF_MEAN|7.589|<|0.0001|TWO_SIDED|90.0|-62.6|-37.5|||Mixed Models Analysis|||||-37.5|-62.6|<.0001
70940601|NCT05319756|141381334|OTHER||Mean Difference (Final Values)|-53.1|STANDARD_ERROR_OF_MEAN|7.611|<|0.0001|TWO_SIDED|90.0|-65.7|-40.5|||Mixed Models Analysis|||||-40.5|-65.7|<.0001
71074719|NCT01362244|141658567|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09||||0.365|TWO_SIDED|95.0|-0.1|0.28|||repeated measures model||Week 9|||0.28|-0.10|0.365
70940602|NCT05319756|141381334|OTHER||Mean Difference (Final Values)|4.32|STANDARD_ERROR_OF_MEAN|7.589||0.5699|TWO_SIDED|90.0|-8.22|16.86|||Mixed Models Analysis|||||16.86|-8.22|0.5699
70940603|NCT05319756|141381334|OTHER||Mean Difference (Final Values)|11.7|STANDARD_ERROR_OF_MEAN|7.581||0.1243|TWO_SIDED|90.0|-0.83|24.23|||Mixed Models Analysis|||||24.23|-0.83|0.1243
70940604|NCT05319756|141381336|OTHER||Mean Difference (Final Values)|286.7|STANDARD_ERROR_OF_MEAN|50.879|<|0.0001|TWO_SIDED|90.0|202.6|370.8|||Mixed Models Analysis|||||370.8|202.6|<.0001
70940605|NCT05319756|141381336|OTHER||Mean Difference (Final Values)|53.85|STANDARD_ERROR_OF_MEAN|50.879||0.2912|TWO_SIDED|90.0|-30.2|137.9|||Mixed Models Analysis|||||137.9|-30.2|0.2912
70940606|NCT05319756|141381336|OTHER||Mean Difference (Final Values)|97.8|STANDARD_ERROR_OF_MEAN|50.938||0.0563|TWO_SIDED|90.0|13.62|182.0|||Mixed Models Analysis|||||182.0|13.62|0.0563
71074720|NCT01362244|141658567|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17||||0.058|TWO_SIDED|95.0|-0.01|0.34|||repeated measures model||Week 13|||0.34|-0.01|0.058
70940607|NCT05319756|141381336|OTHER||Mean Difference (Final Values)|484.5|STANDARD_ERROR_OF_MEAN|51.083|<|0.0001|TWO_SIDED|90.0|400.1|569.0|||Mixed Models Analysis|||||569.0|400.1|<.0001
71116190|NCT03268954|141738786|SUPERIORITY||Hazard Ratio (HR)|0.877|||=|0.24|TWO_SIDED|95.0|0.608|1.263||P-value comparing EFS between treatment groups was based on 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||HR:unadjusted stratified Cox proportional hazard regression with stratification factors (IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1:better prevention of EFS in combination arm than azacitidine arm.|Event-Free Survival in Participants who have TP53 Mutations, 17p Deletions, and/or are Determined to be in an Adverse Cytogenetic Risk Group||1.263|0.608|=0.240
71074721|NCT01362244|141658567|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21||||0.056|TWO_SIDED|95.0|-0.01|0.43|||repeated measures model||Week 17|||0.43|-0.01|0.056
71074722|NCT01362244|141658567|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23||||0.028|TWO_SIDED|95.0|0.03|0.42|||repeated measures model||Week 21|||0.42|0.03|0.028
71074723|NCT01362244|141658567|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16||||0.077|TWO_SIDED|95.0|-0.02|0.34|||repeated measures model||Week 25|||0.34|-0.02|0.077
71074724|NCT01362244|141658568|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06||||0.486|TWO_SIDED|95.0|-0.1|0.22|||repeated measures model||Week 2|||0.22|-0.10|0.486
71074725|NCT01362244|141658568|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07||||0.384|TWO_SIDED|95.0|-0.08|0.22|||repeated measures model||Week 5|||0.22|-0.08|0.384
71074726|NCT01362244|141658568|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06||||0.546|TWO_SIDED|95.0|-0.14|0.26|||repeated measures model||Week 9|||0.26|-0.14|0.546
71074727|NCT01362244|141658568|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.05|TWO_SIDED|95.0|0.0|0.39|||repeated measures model||Week 13|||0.39|0.00|0.050
71074728|NCT01362244|141658568|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22||||0.061|TWO_SIDED|95.0|-0.01|0.45|||repeated measures model||Week 17|||0.45|-0.01|0.061
70940608|NCT05319756|141381336|OTHER||Mean Difference (Final Values)|396.6|STANDARD_ERROR_OF_MEAN|50.938|<|0.0001|TWO_SIDED|90.0|312.4|480.8|||Mixed Models Analysis|||||480.8|312.4|<.0001
70940609|NCT05319756|141381336|OTHER||Mean Difference (Final Values)|-233.0|STANDARD_ERROR_OF_MEAN|50.938|<|0.0001|TWO_SIDED|90.0|-317.0|-149.0|||Mixed Models Analysis|||||-149|-317|<.0001
70940610|NCT05319756|141381336|OTHER||Mean Difference (Final Values)|-189.0|STANDARD_ERROR_OF_MEAN|51.083||0.0003|TWO_SIDED|90.0|-273.0|-105.0|||Mixed Models Analysis|||||-105|-273|0.0003
70940611|NCT05319756|141381336|OTHER||Mean Difference (Final Values)|197.8|STANDARD_ERROR_OF_MEAN|50.938||0.0001|TWO_SIDED|90.0|113.7|282.0|||Mixed Models Analysis|||||282.0|113.7|0.0001
70940612|NCT05319756|141381336|OTHER||Mean Difference (Final Values)|109.9|STANDARD_ERROR_OF_MEAN|50.879||0.032|TWO_SIDED|90.0|25.8|194.0|||Mixed Models Analysis|||||194.0|25.80|0.0320
70940613|NCT05319756|141381337|OTHER||Mean Difference (Final Values)|18.73|STANDARD_ERROR_OF_MEAN|2.276|<|0.0001|TWO_SIDED|90.0|14.98|22.48|||Mixed Models Analysis|||||22.48|14.98|<0.0001
70940614|NCT05319756|141381337|OTHER||Mean Difference (Final Values)|1.76|STANDARD_ERROR_OF_MEAN|2.302||0.5056|TWO_SIDED|90.0|-2.03|5.56|||Mixed Models Analysis|||||5.56|-2.03|0.5056
70940615|NCT05319756|141381337|OTHER||Mean Difference (Final Values)|4.62|STANDARD_ERROR_OF_MEAN|2.307||0.076|TWO_SIDED|90.0|0.82|8.42|||Mixed Models Analysis|||||8.42|0.82|0.0760
70940616|NCT05319756|141381337|OTHER||Mean Difference (Final Values)|25.73|STANDARD_ERROR_OF_MEAN|2.315|<|0.0001|TWO_SIDED|90.0|21.92|29.54|||Mixed Models Analysis|||||29.54|21.92|<0.0001
70940617|NCT05319756|141381337|OTHER||Mean Difference (Final Values)|24.42|STANDARD_ERROR_OF_MEAN|2.27|<|0.0001|TWO_SIDED|90.0|20.68|28.16|||Mixed Models Analysis|||||28.16|20.68|<0.0001
70940618|NCT05319756|141381337|OTHER||Mean Difference (Final Values)|-17.0|STANDARD_ERROR_OF_MEAN|2.297|<|0.0001|TWO_SIDED|90.0|-20.8|-13.2|||Mixed Models Analysis|||||-13.2|-20.8|<0.0001
70940619|NCT05319756|141381337|OTHER||Mean Difference (Final Values)|-14.1|STANDARD_ERROR_OF_MEAN|2.299|<|0.0001|TWO_SIDED|90.0|-17.9|-10.3|||Mixed Models Analysis|||||-10.3|-17.9|<0.0001
70940620|NCT05319756|141381337|OTHER||Mean Difference (Final Values)|7.0|STANDARD_ERROR_OF_MEAN|2.298||0.0024|TWO_SIDED|90.0|3.22|10.79|||Mixed Models Analysis|||||10.79|3.22|0.0024
70940621|NCT05319756|141381337|OTHER||Mean Difference (Final Values)|5.69|STANDARD_ERROR_OF_MEAN|2.255||0.0118|TWO_SIDED|90.0|1.98|9.41|||Mixed Models Analysis|||||9.41|1.98|0.0118
70940622|NCT05319756|141381338|OTHER||Mean Difference (Final Values)|20.31|STANDARD_ERROR_OF_MEAN|2.246|<|0.0001|TWO_SIDED|90.0|16.61|24.01|||Mixed Models Analysis|||||24.01|16.61|<0.0001
70940623|NCT05319756|141381338|OTHER||Mean Difference (Final Values)|2.65|STANDARD_ERROR_OF_MEAN|2.271||0.2439|TWO_SIDED|90.0|-1.09|6.39|||Mixed Models Analysis|||||6.39|-1.09|0.2439
70940624|NCT05319756|141381338|OTHER||Mean Difference (Final Values)|6.5|STANDARD_ERROR_OF_MEAN|2.276||0.0044|TWO_SIDED|90.0|2.75|10.25|||Mixed Models Analysis|||||10.25|2.75|0.0044
70940625|NCT05319756|141381338|OTHER||Mean Difference (Final Values)|24.15|STANDARD_ERROR_OF_MEAN|2.284|<|0.0001|TWO_SIDED|90.0|20.39|27.91|||Mixed Models Analysis|||||27.91|20.39|<0.0001
70940626|NCT05319756|141381338|OTHER||Mean Difference (Final Values)|28.19|STANDARD_ERROR_OF_MEAN|2.24|<|0.0001|TWO_SIDED|90.0|24.5|31.88|||Mixed Models Analysis|||||31.88|24.50|<0.0001
70940627|NCT05319756|141381338|OTHER||Mean Difference (Final Values)|-17.7|STANDARD_ERROR_OF_MEAN|2.266|<|0.0001|TWO_SIDED|90.0|-21.4|-13.9|||Mixed Models Analysis|||||-13.9|-21.4|<0.0001
70940628|NCT05319756|141381338|OTHER||Mean Difference (Final Values)|-13.8|STANDARD_ERROR_OF_MEAN|2.268|<|0.0001|TWO_SIDED|90.0|-17.5|-10.1|||Mixed Models Analysis|||||-10.1|-17.5|<0.0001
70940629|NCT05319756|141381338|OTHER||Mean Difference (Final Values)|3.84|STANDARD_ERROR_OF_MEAN|2.267||0.0907|TWO_SIDED|90.0|0.11|7.57|||Mixed Models Analysis|||||7.57|0.11|0.0907
70940630|NCT05319756|141381338|OTHER||Mean Difference (Final Values)|7.88|STANDARD_ERROR_OF_MEAN|2.225||0.0004|TWO_SIDED|90.0|4.22|11.55|||Mixed Models Analysis|||||11.55|4.22|0.0004
70940631|NCT05319756|141381339|OTHER||Mean Difference (Final Values)|25.37|STANDARD_ERROR_OF_MEAN|1.528|<|0.0001|TWO_SIDED|90.0|22.86|27.88|||Mixed Models Analysis|||||27.88|22.86|<0.0001
70940632|NCT05319756|141381339|OTHER||Mean Difference (Final Values)|3.59|STANDARD_ERROR_OF_MEAN|1.529||0.0189|TWO_SIDED|90.0|1.08|6.11|||Mixed Models Analysis|||||6.11|1.08|0.0189
71074729|NCT01362244|141658568|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28||||0.016|TWO_SIDED|95.0|0.05|0.51|||repeated measures model||Week 21|||0.51|0.05|0.016
71074730|NCT01362244|141658568|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18||||0.094|TWO_SIDED|95.0|-0.03|0.4|||repeated measures model||Week 25|||0.40|-0.03|0.094
71074731|NCT01362244|141658569|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.11||||0.686|TWO_SIDED|95.0|-19.91|30.12|||repeated measures model||Week 2|||30.12|-19.91|0.686
71074732|NCT01362244|141658569|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.55||||0.321|TWO_SIDED|95.0|-14.4|43.5|||repeated measures model||Week 5|||43.50|-14.40|0.321
71074733|NCT01362244|141658569|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.91||||0.622|TWO_SIDED|95.0|-26.79|44.6|||repeated measures model||Week 9|||44.60|-26.79|0.622
71074734|NCT01362244|141658569|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|23.24||||0.178|TWO_SIDED|95.0|-10.75|57.22|||repeated measures model||Week 13|||57.22|-10.75|0.178
71074735|NCT01362244|141658569|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|38.16||||0.052|TWO_SIDED|95.0|-0.33|76.66|||repeated measures model||Week 17|||76.66|-0.33|0.052
71074736|NCT01362244|141658569|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|38.72||||0.042|TWO_SIDED|95.0|1.41|76.02|||repeated measures model||Week 21|||76.02|1.41|0.042
71074737|NCT01362244|141658569|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.13||||0.484|TWO_SIDED|95.0|-25.76|54.02|||repeated measures model||Week 25|||54.02|-25.76|0.484
71074738|NCT01362244|141658571|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.16||||0.005|TWO_SIDED|95.0|6.49|35.83|||repeated measures model||Week 2|||35.83|6.49|0.005
71074739|NCT01362244|141658571|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|16.89||||0.029|TWO_SIDED|95.0|1.77|32.01|||repeated measures model||Week 5|||32.01|1.77|0.029
71074740|NCT01362244|141658571|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.2||||0.472|TWO_SIDED|95.0|-12.64|27.03|||repeated measures model||Week 9|||27.03|-12.64|0.472
71074741|NCT01362244|141658571|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|27.71||||0.009|TWO_SIDED|95.0|7.19|48.23|||repeated measures model||Week 13|||48.23|7.19|0.009
71074742|NCT01362244|141658571|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.4||||0.114|TWO_SIDED|95.0|-3.8|34.59|||repeated measures model||Week 17|||34.59|-3.80|0.114
71074743|NCT01362244|141658571|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29.51||||0.014|TWO_SIDED|95.0|6.06|52.96|||repeated measures model||Week 21|||52.96|6.06|0.014
70940633|NCT05319756|141381339|OTHER||Mean Difference (Final Values)|6.18|STANDARD_ERROR_OF_MEAN|1.536|<|0.0001|TWO_SIDED|90.0|3.66|8.71|||Mixed Models Analysis|||||8.71|3.66|<0.0001
70940634|NCT05319756|141381339|OTHER||Mean Difference (Final Values)|32.18|STANDARD_ERROR_OF_MEAN|1.537|<|0.0001|TWO_SIDED|90.0|29.65|34.71|||Mixed Models Analysis|||||34.71|29.65|<0.0001
70940635|NCT05319756|141381339|OTHER||Mean Difference (Final Values)|30.17|STANDARD_ERROR_OF_MEAN|1.525|<|0.0001|TWO_SIDED|90.0|27.66|32.68|||Mixed Models Analysis|||||32.68|27.66|<0.0001
71074744|NCT01362244|141658571|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|26.65||||0.027|TWO_SIDED|95.0|3.1|50.21|||repeated measures model||Week 25|||50.21|3.10|0.027
71074745|NCT01362244|141658572|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09||||0.79|TWO_SIDED|95.0|-0.61|0.79|||repeated measures model||MNS, Week 2|||0.79|-0.61|0.790
71074746|NCT01362244|141658572|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.14||||0.008|TWO_SIDED|95.0|0.3|1.97|||repeated measures model||MNS, Week 5|||1.97|0.30|0.008
71074747|NCT01362244|141658572|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.79||||0.066|TWO_SIDED|95.0|-0.05|1.64|||repeated measures model||MNS, Week 9|||1.64|-0.05|0.066
71074748|NCT01362244|141658572|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.73||||0.127|TWO_SIDED|95.0|-0.21|1.67|||repeated measures model||MNS, Week 13|||1.67|-0.21|0.127
71074749|NCT01362244|141658572|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.38||||0.481|TWO_SIDED|95.0|-0.69|1.46|||repeated measures model||MNS, Week 17|||1.46|-0.69|0.481
71074750|NCT01362244|141658572|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.65||||0.308|TWO_SIDED|95.0|-0.61|1.9|||repeated measures model||MNS, Week 21|||1.90|-0.61|0.308
70940636|NCT05319756|141381339|OTHER||Mean Difference (Final Values)|-21.8|STANDARD_ERROR_OF_MEAN|1.522|<|0.0001|TWO_SIDED|90.0|-24.3|-19.3|||Mixed Models Analysis|||||-19.3|-24.3|<0.0001
70940637|NCT05319756|141381339|OTHER||Mean Difference (Final Values)|-19.2|STANDARD_ERROR_OF_MEAN|1.53|<|0.0001|TWO_SIDED|90.0|-21.7|-16.7|||Mixed Models Analysis|||||-16.7|-21.7|<0.0001
70940638|NCT05319756|141381339|OTHER||Mean Difference (Final Values)|6.81|STANDARD_ERROR_OF_MEAN|1.524|<|0.0001|TWO_SIDED|90.0|4.3|9.31|||Mixed Models Analysis|||||9.31|4.30|<0.0001
70940639|NCT05319756|141381339|OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|1.514||0.0015|TWO_SIDED|90.0|2.31|7.29|||Mixed Models Analysis|||||7.29|2.31|0.0015
70940640|NCT05319756|141381340|OTHER||Mean Difference (Final Values)|4.23|STANDARD_ERROR_OF_MEAN|0.743|<|0.0001|TWO_SIDED|90.0|3.01|5.45|||Mixed Models Analysis|||||5.45|3.01|<.0001
70940641|NCT05319756|141381340|OTHER||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.743||0.3933|TWO_SIDED|90.0|-0.59|1.86|||Mixed Models Analysis|||||1.86|-0.59|0.3933
70940642|NCT05319756|141381340|OTHER||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|0.747||0.2916|TWO_SIDED|90.0|-0.44|2.02|||Mixed Models Analysis|||||2.02|-0.44|0.2916
71074751|NCT01362244|141658572|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.71||||0.233|TWO_SIDED|95.0|-0.46|1.88|||repeated measures model||MNS, Week 25|||1.88|-0.46|0.233
71074752|NCT01362244|141658572|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28||||0.444|TWO_SIDED|95.0|-0.45|1.02|||repeated measures model||WNS, Week 2|||1.02|-0.45|0.444
70940643|NCT05319756|141381340|OTHER||Mean Difference (Final Values)|3.92|STANDARD_ERROR_OF_MEAN|0.748|<|0.0001|TWO_SIDED|90.0|2.69|5.15|||Mixed Models Analysis|||||5.15|2.69|<.0001
70940644|NCT05319756|141381340|OTHER||Mean Difference (Final Values)|3.22|STANDARD_ERROR_OF_MEAN|0.742|<|0.0001|TWO_SIDED|90.0|2.0|4.44|||Mixed Models Analysis|||||4.44|2.00|<.0001
70940645|NCT05319756|141381340|OTHER||Mean Difference (Final Values)|-3.59|STANDARD_ERROR_OF_MEAN|0.74|<|0.0001|TWO_SIDED|90.0|-4.81|-2.38|||Mixed Models Analysis|||||-2.38|-4.81|<.0001
71116191|NCT03268954|141738787|SUPERIORITY||Hazard Ratio (HR)|0.826|||=|0.145|TWO_SIDED|95.0|0.58|1.178||P-value comparing OS between treatment groups was based on 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||HR:unadjusted stratified Cox proportional hazard regression with stratification factors(IPSS-R risk groups of very high,high,intermediate) and treatment as factor in model.HR\<1: longer survival time in combination arm than azacitidine arm.|Overall Survival in Participants who have TP53 Mutations, 17p Deletions, and/or are Determined to be in an Adverse Cytogenetic Risk Group||1.178|0.580|=0.145
70940646|NCT05319756|141381340|OTHER||Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|0.744|<|0.0001|TWO_SIDED|90.0|-4.66|-2.22|||Mixed Models Analysis|||||-2.22|-4.66|<.0001
70940647|NCT05319756|141381340|OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.741||0.6765|TWO_SIDED|90.0|-1.53|0.91|||Mixed Models Analysis|||||0.91|-1.53|0.6765
70940648|NCT05319756|141381340|OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|0.737||0.1712|TWO_SIDED|90.0|-2.22|0.2|||Mixed Models Analysis|||||0.20|-2.22|0.1712
70940649|NCT05319756|141381341|OTHER||Mean Difference (Final Values)|24.7|STANDARD_ERROR_OF_MEAN|1.526|<|0.0001|TWO_SIDED|90.0|22.19|27.21|||Mixed Models Analysis|||||27.21|22.19|<.0001
70940650|NCT05319756|141381341|OTHER||Mean Difference (Final Values)|2.87|STANDARD_ERROR_OF_MEAN|1.527||0.0606|TWO_SIDED|90.0|0.35|5.38|||Mixed Models Analysis|||||5.38|0.35|0.0606
70940651|NCT05319756|141381341|OTHER||Mean Difference (Final Values)|4.11|STANDARD_ERROR_OF_MEAN|1.534||0.0074|TWO_SIDED|90.0|1.59|6.64|||Mixed Models Analysis|||||6.64|1.59|0.0074
71074753|NCT01362244|141658572|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.31||||0.002|TWO_SIDED|95.0|0.5|2.12|||repeated measures model||WNS, Week 5|||2.12|0.50|0.002
71074754|NCT01362244|141658572|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.68||||0.143|TWO_SIDED|95.0|-0.24|1.6|||repeated measures model||WNS, Week 9|||1.60|-0.24|0.143
71074755|NCT01362244|141658572|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.62||||0.24|TWO_SIDED|95.0|-0.42|1.65|||repeated measures model||WNS, Week 13|||1.65|-0.42|0.240
71074756|NCT01362244|141658572|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19||||0.75|TWO_SIDED|95.0|-0.98|1.35|||repeated measures model||WNS, Week 17|||1.35|-0.98|0.750
71074757|NCT01362244|141658572|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.64||||0.324|TWO_SIDED|95.0|-0.64|1.91|||repeated measures model||WNS, Week 21|||1.91|-0.64|0.324
71074758|NCT01362244|141658572|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.44||||0.468|TWO_SIDED|95.0|-0.77|1.66|||repeated measures model||WNS, Week 25|||1.66|-0.77|0.468
70940652|NCT05319756|141381341|OTHER||Mean Difference (Final Values)|30.58|STANDARD_ERROR_OF_MEAN|1.536|<|0.0001|TWO_SIDED|90.0|28.05|33.1|||Mixed Models Analysis|||||33.10|28.05|<.0001
70940653|NCT05319756|141381341|OTHER||Mean Difference (Final Values)|29.99|STANDARD_ERROR_OF_MEAN|1.524|<|0.0001|TWO_SIDED|90.0|27.48|32.5|||Mixed Models Analysis|||||32.50|27.48|<.0001
70940654|NCT05319756|141381341|OTHER||Mean Difference (Final Values)|-21.8|STANDARD_ERROR_OF_MEAN|1.521|<|0.0001|TWO_SIDED|90.0|-24.3|-19.3|||Mixed Models Analysis|||||-19.3|-24.3|<.0001
70940655|NCT05319756|141381341|OTHER||Mean Difference (Final Values)|-20.6|STANDARD_ERROR_OF_MEAN|1.529|<|0.0001|TWO_SIDED|90.0|-23.1|-18.1|||Mixed Models Analysis|||||-18.1|-23.1|<.0001
70940656|NCT05319756|141381341|OTHER||Mean Difference (Final Values)|5.88|STANDARD_ERROR_OF_MEAN|1.523||0.0001|TWO_SIDED|90.0|3.37|8.38|||Mixed Models Analysis|||||8.38|3.37|0.0001
70940657|NCT05319756|141381341|OTHER||Mean Difference (Final Values)|5.29|STANDARD_ERROR_OF_MEAN|1.513||0.0005|TWO_SIDED|90.0|2.8|7.78|||Mixed Models Analysis|||||7.78|2.80|0.0005
70940658|NCT00422162|141381352|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||P-value for Change from Baseline. A priori alpha threshold was 0.05 with no adjustment for multiple testing.|ANCOVA|ANCOVA with stratification factors (country and pretreatment for MDD) and MADRS baseline as covariates and treatment regimen as the main factor.||||||0.88
70940659|NCT00422162|141381362|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for Change from Baseline (within group)|t-test, 2 sided|paired t-test||||||<0.0001
71074759|NCT01362244|141658573|SUPERIORITY_OR_OTHER_LEGACY||Mixed effects model|-13.2||||0.005|TWO_SIDED|95.0|-22.2|-4.22|||ANCOVA|||||-4.22|-22.2|0.005
70940660|NCT00422162|141381362|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Change from Baseline (within group)|t-test, 2 sided|paired t-test||||||0.001
70940661|NCT00422162|141381362|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for Change from Baseline (within group)|t-test, 2 sided|paired t-test||||||<0.0001
70940662|NCT00422162|141381362|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||P-value for Change from Baseline (within group)|t-test, 2 sided|paired t-test||||||0.28
70940663|NCT01357564|141381414|SUPERIORITY||Mean Difference (Net)|-0.72||||0.02|TWO_SIDED|95.0|-1.23|-0.13|||t-test, 2 sided|||Sample size calculation was based on the main study hypothesis tested at 80% power for a 2-sided alternative hypothesis using a t-test comparing the treatment groups on 4-month values. Based on previous trials, we sought a medium effect size of 0.50 using a type I error rate of .05.||-0.13|-1.23|.02
70940664|NCT01357564|141381415|SUPERIORITY||Mean Difference (Net)|-0.1||||0.03|TWO_SIDED|95.0|-0.14|-0.01|||t-test, 2 sided|||Sample size calculation was based on the main study hypothesis tested at 80% power for a 2-sided alternative hypothesis using a t-test comparing the treatment groups on 4-month values. Based on previous trials, we sought a medium effect size of 0.50 using a type I error rate of .05.||-0.01|-0.14|.03
70940665|NCT02332824|141381435|SUPERIORITY_OR_OTHER||LS Mean difference|-0.325|||<|0.0001|TWO_SIDED|95.0|-0.4845|-0.1649||In the primary analysis, each TAK-272 group will be compared with placebo group based on a step-down testing procedure, which will be employed for multiple comparison adjustment.|ANCOVA||Estimated Value was for LS mean differences (TAK-272 5 mg-placebo) in log-transformed UACR changes from baseline to the end of treatment period.|||-0.1649|-0.4845|<0.0001
70940666|NCT02332824|141381435|SUPERIORITY_OR_OTHER||LS Mean difference|-0.469|||<|0.0001|TWO_SIDED|95.0|-0.6251|-0.3132||In the primary analysis, each TAK-272 group will be compared with placebo group based on a step-down testing procedure, which will be employed for multiple comparison adjustment.|ANCOVA||Estimated Value was for LS mean differences (TAK-272 20 mg-placebo) in log-transformed UACR changes from baseline to the end of treatment period.|||-0.3132|-0.6251|<0.0001
70940667|NCT02332824|141381435|SUPERIORITY_OR_OTHER||LS Mean difference|-0.63|||<|0.0001|TWO_SIDED|95.0|-0.7897|-0.4711||In the primary analysis, each TAK-272 group will be compared with placebo group based on a step-down testing procedure, which will be employed for multiple comparison adjustment.|ANCOVA||Estimated Value was for LS mean differences (TAK-272 40 mg -placebo) in log-transformed UACR changes from baseline to the end of treatment period.|||-0.4711|-0.7897|<0.0001
70940668|NCT02332824|141381435|SUPERIORITY_OR_OTHER||LS Mean difference|-0.65|||<|0.0001|TWO_SIDED|95.0|-0.8083|-0.4908||In the primary analysis, each TAK-272 group will be compared with placebo group based on a step-down testing procedure, which will be employed for multiple comparison adjustment.|ANCOVA||Estimated Value was for LS mean differences (TAK-272 80 mg -placebo) in log-transformed UACR changes from baseline to the end of treatment period.|||-0.4908|-0.8083|<0.0001
71074760|NCT01362244|141658574|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.06|0.07||||||||0.07|-0.06|
71116192|NCT03268954|141738788|SUPERIORITY||Absolute Rate Difference|-5.14|||=|0.261|TWO_SIDED|95.0|-13.95|3.68||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test stratified by IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Cochran-Mantel-Haenszel|||Overall Response for HR MDS/CMML||3.68|-13.95|=0.261
70940669|NCT02332824|141381435|SUPERIORITY_OR_OTHER||LS Mean difference|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.6874|-0.3719||In the primary analysis, each TAK-272 group will be compared with placebo group based on a step-down testing procedure, which will be employed for multiple comparison adjustment.|ANCOVA||Estimated Value was for LS mean differences (Candesartan cilexetil 8 mg -placebo group) in log-transformed UACR changes from baseline to the end of treatment period.|||-0.3719|-0.6874|<0.0001
71074761|NCT01362244|141658575|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.68|||||TWO_SIDED|95.0|-1.33|12.68||||||||12.68|-1.33|
71074762|NCT05153148|141658588|SUPERIORITY||Risk Difference (RD)|5.9|||=|0.446|TWO_SIDED|95.0|-9.3|21.1|||Cochran-Mantel-Haenszel||Mantel-Haenszel (MH) risk difference was summarized along with the 2-sided 95% confidence interval (CI) using MH stratum weights and the Sato variance estimator.||Comparisons of ACR20 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional disease-modifying antirheumatic drugs (DMARDs) and region.|21.1|-9.3|=0.446
71074763|NCT05153148|141658588|SUPERIORITY||Risk Difference (RD)|24.1|||=|0.002|TWO_SIDED|95.0|8.6|39.6|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of ACR20 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|39.6|8.6|=0.002
71074764|NCT05153148|141658588|SUPERIORITY||Risk Difference (RD)|24.5|||=|0.002|TWO_SIDED|95.0|9.0|39.9|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of ACR20 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|39.9|9.0|=0.002
70940670|NCT03840148|141381440|NON_INFERIORITY|If the lower limit of the 95% CI for the difference in response is greater than or equal to the non-inferiority margin of -15%, non-inferiority will be concluded. Further, if non-inferiority is concluded, superiority will be concluded if the lower limit of the 95% CI for the difference in response is greater than or equal to zero.|Miettinen and Nurminen|12.6||||0.0088|TWO_SIDED|95.0|3.1|22.2||P-value for superiority since the lower confidence interval is greater than 0 for the primary endpoint analysis.|Cochran-Mantel-Haenszel|||||22.2|3.1|0.0088
70940671|NCT03840148|141381441|OTHER||Miettinen and Nurminen|11.7|||||TWO_SIDED|95.0|2.9|21.0||||||||21.0|2.9|
70940672|NCT03840148|141381442|OTHER||Miettinen and Nurminen|4.5|||||TWO_SIDED|95.0|-2.6|12.6||||||||12.6|-2.6|
70940673|NCT03840148|141381443|OTHER||Miettinen and Nurminen|12.3|||||TWO_SIDED|95.0|3.0|21.8||||||||21.8|3.0|
70940674|NCT03840148|141381444|OTHER||Miettinen and Nurminen|3.1|||||TWO_SIDED|95.0|-3.2|10.4||||||||10.4|-3.2|
70940675|NCT03840148|141381445|OTHER||Miettinen and Nurminen|-0.3|||||TWO_SIDED|95.0|-3.5|4.1||||||||4.1|-3.5|
70940676|NCT03840148|141381446|OTHER||Miettinen and Nurminen|1.6|||||TWO_SIDED|95.0|-4.1|8.5||||||||8.5|-4.1|
70940677|NCT03840148|141381447|OTHER||Miettinen and Nurminen|12.1|||||TWO_SIDED|95.0|2.2|21.9||||||||21.9|2.2|
71116193|NCT03268954|141738788|SUPERIORITY||Absolute Rate Difference|22.36|||=|0.026|TWO_SIDED|95.0|3.22|41.49||P-value was obtained from an unstratified Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel|||Overall Response for Low-blast AML||41.49|3.22|=0.026
71116194|NCT03802630|141738789|NON_INFERIORITY|Non-inferiority was considered established if the lower limit of the corresponding 95% CI for the estimated between group difference (brolucizumab vs. aflibercept) on change from baseline in BCVA at Week 24 is greater than -4 letters.|Least Square Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.01||0.018|TWO_SIDED|95.0|-3.9|0.1|||ANOVA|||||0.1|-3.9|0.018
71074765|NCT05153148|141658589|SUPERIORITY||Risk Difference (RD)|5.7|||=|0.312|TWO_SIDED|95.0|-5.3|16.6|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of ACR50 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|16.6|-5.3|=0.312
71074766|NCT05153148|141658589|SUPERIORITY||Risk Difference (RD)|17.0|||=|0.005|TWO_SIDED|95.0|5.0|29.1|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of ACR50 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|29.1|5.0|=0.005
71074767|NCT05153148|141658589|SUPERIORITY||Risk Difference (RD)|16.4|||=|0.009|TWO_SIDED|95.0|4.2|28.6|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of ACR50 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|28.6|4.2|=0.009
71074768|NCT05153148|141658590|SUPERIORITY||Risk Difference (RD)|2.9|||=|0.532|TWO_SIDED|95.0|-6.6|12.7|||Fisher Exact||Comparisons of ACR70 responder rates at Week 12 were made independently between each dose group and the placebo group using Fischer's exact Method.|||12.7|-6.6|=0.532
71074769|NCT05153148|141658590|SUPERIORITY||Risk Difference (RD)|9.1|||=|0.101|TWO_SIDED|95.0|-1.0|20.1|||Fisher Exact||Comparisons of ACR70 responder rates at Week 12 were made independently between each dose group and the placebo group using Fischer's exact Method.|||20.1|-1.0|=0.101
71074770|NCT05153148|141658590|SUPERIORITY||Risk Difference (RD)|8.3|||=|0.158|TWO_SIDED|95.0|-1.7|19.4|||Fisher Exact||Comparisons of ACR70 responder rates at Week 12 were made independently between each dose group and the placebo group using Fischer's exact Method.|||19.4|-1.7|=0.158
71074771|NCT05153148|141658591|SUPERIORITY||Treatment Difference|-1.7|||=|0.268|TWO_SIDED|95.0|-4.8|1.3|||Mixed Model Repeated Measure (MMRM)||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|1.3|-4.8|=0.268
71074772|NCT05153148|141658591|SUPERIORITY||Treatment Difference|-3.0|||=|0.051|TWO_SIDED|95.0|-6.1|0.0|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.0|-6.1|=0.051
71074773|NCT05153148|141658591|SUPERIORITY||Treatment Difference|-2.5|||=|0.112|TWO_SIDED|95.0|-5.6|0.6|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.6|-5.6|=0.112
71074774|NCT05153148|141658592|SUPERIORITY||Treatment Difference|-0.9|||=|0.28|TWO_SIDED|95.0|-2.4|0.7|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.7|-2.4|=0.280
71074775|NCT05153148|141658592|SUPERIORITY||Treatment Difference|-1.1|||=|0.177|TWO_SIDED|95.0|-2.6|0.5|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.5|-2.6|=0.177
71074776|NCT05153148|141658592|SUPERIORITY||Treatment Difference|-1.0|||=|0.196|TWO_SIDED|95.0|-2.6|0.5|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.5|-2.6|=0.196
71116195|NCT06099223|141738819|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71116196|NCT06099223|141738820|SUPERIORITY|||||||0.029|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.029
71116197|NCT06099223|141738822|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71116198|NCT06099223|141738823|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
70940678|NCT03840148|141381448|OTHER||Miettinen and Nurminen|7.7|||||TWO_SIDED|95.0|-1.6|17.3||||||||17.3|-1.6|
70940679|NCT03840148|141381449|OTHER||Miettinen and Nurminen|9.9|||||TWO_SIDED|95.0|1.5|18.8||||||||18.8|1.5|
70940680|NCT03840148|141381450|OTHER||Miettinen and Nurminen|3.0|||||TWO_SIDED|95.0|-2.4|9.6||||||||9.6|-2.4|
70940681|NCT03840148|141381460|OTHER||Miettinen and Nurminen|3.5|||||TWO_SIDED|95.0|-2.3|10.5||||||||10.5|-2.3|
70940682|NCT03840148|141381461|OTHER||Miettinen and Nurminen|-1.1|||||TWO_SIDED|95.0|-3.1|1.7||||||||1.7|-3.1|
70940683|NCT03840148|141381462|OTHER||Miettinen and Nurminen|14.9|||||TWO_SIDED|95.0|5.0|24.9||||||||24.9|5.0|
70940684|NCT03840148|141381463|OTHER||Miettinen and Nurminen|12.7|||||TWO_SIDED|95.0|3.7|22.3||||||||22.3|3.7|
71074777|NCT05153148|141658593|SUPERIORITY||Treatment Difference|-1.9|||=|0.637|TWO_SIDED|95.0|-9.6|5.9|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|5.9|-9.6|=0.637
71074778|NCT05153148|141658593|SUPERIORITY||Treatment Difference|-9.2|||=|0.021|TWO_SIDED|95.0|-17.0|-1.4|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|-1.4|-17.0|=0.021
71074779|NCT05153148|141658593|SUPERIORITY||Treatment Difference|-8.7|||=|0.03|TWO_SIDED|95.0|-16.5|-0.9|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|-0.9|-16.5|=0.030
71074780|NCT05153148|141658594|SUPERIORITY||Treatment Difference|-0.9|||=|0.812|TWO_SIDED|95.0|-8.4|6.6|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|6.6|-8.4|=0.812
71074781|NCT05153148|141658594|SUPERIORITY||Treatment Difference|-6.7|||=|0.079|TWO_SIDED|95.0|-14.2|0.8|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.8|-14.2|=0.079
71074782|NCT05153148|141658594|SUPERIORITY||Treatment Difference|-6.3|||=|0.102|TWO_SIDED|95.0|-13.9|1.3|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|1.3|-13.9|=0.102
71074783|NCT05153148|141658595|SUPERIORITY||Treatment Difference|-8.9|||=|0.016|TWO_SIDED|95.0|-16.2|-1.7|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|-1.7|-16.2|=0.016
71074784|NCT05153148|141658595|SUPERIORITY||Treatment Difference|-10.6|||=|0.004|TWO_SIDED|95.0|-17.8|-3.4|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|-3.4|-17.8|=0.004
71074785|NCT05153148|141658595|SUPERIORITY||Treatment Difference|-10.9|||=|0.003|TWO_SIDED|95.0|-18.2|-3.6|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|-3.6|-18.2|=0.003
71074786|NCT05153148|141658596|SUPERIORITY||Treatment Difference|-0.07|||=|0.357|TWO_SIDED|95.0|-0.21|0.08|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.08|-0.21|=0.357
71074787|NCT05153148|141658596|SUPERIORITY||Treatment Difference|-0.1|||=|0.195|TWO_SIDED|95.0|-0.24|0.05|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.05|-0.24|=0.195
71074788|NCT05153148|141658596|SUPERIORITY||Treatment Difference|-0.05|||=|0.467|TWO_SIDED|95.0|-0.2|0.09|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.09|-0.20|=0.467
71074789|NCT05153148|141658597|SUPERIORITY||Treatment Difference|1.3|||=|0.031|TWO_SIDED|95.0|0.1|2.4|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|2.4|0.1|=0.031
71074790|NCT05153148|141658597|SUPERIORITY||Treatment Difference|0.1|||=|0.86|TWO_SIDED|95.0|-1.1|1.3|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|1.3|-1.1|=0.860
71074791|NCT05153148|141658597|SUPERIORITY||Treatment Difference|0.2|||=|0.758|TWO_SIDED|95.0|-0.9|1.3|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|1.3|-0.9|=0.758
71116199|NCT06099223|141738824|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||||||0.61
71116200|NCT06099223|141738825|SUPERIORITY|||||||0.37|||||||Chi-squared|||||||0.37
71116201|NCT06099223|141738826|SUPERIORITY|||||||0.11|||||||Fisher Exact|||||||0.11
71116202|NCT06099223|141738827|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
71116203|NCT06099223|141738828|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
71116204|NCT06099223|141738829|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|||||||0.087
71116205|NCT06099223|141738830|SUPERIORITY|||||||0.147|||||||t-test, 2 sided|||||||0.147
71116206|NCT06099223|141738831|SUPERIORITY|||||||0.098|||||||t-test, 2 sided|||||||0.098
71116207|NCT06099223|141738832|SUPERIORITY|||||||0.41|||||||Chi-squared|||||||0.41
71116208|NCT06099223|141738833|SUPERIORITY|||||||0.79|||||||Chi-squared|||||||0.79
71116209|NCT06099223|141738834|SUPERIORITY|||||||0.58|||||||Chi-squared|||||||0.58
71116210|NCT06099223|141738836|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.00
71116211|NCT06099223|141738837|SUPERIORITY|||||||0.919|||||||ANCOVA|||||||0.919
71116212|NCT02488135|141738838|NON_INFERIORITY|An a priori sample size was calculated using a non-inferiority limit (d) set at 25%, significance level (α) of 5% and power of 80%. We assumed that success in each group would be 93% based on the literature examining anterior nasal packing in ideal conditions and considering our selection criteria in the Floseal® (Baxter, USA) population. Attrition was assumed to be 0% due to the short duration of treatment. This yielded 26 participants with 13 patients in each study arm.||||||1|||||||Fisher Exact|||||||1.000
71116213|NCT02488135|141738839|SUPERIORITY|||||||0.0022|||||||Wilcoxon (Mann-Whitney)|||Comparison between groups for pain during placement.||||0.0022
71116214|NCT02488135|141738839|SUPERIORITY|||||||0.0007|||||||Wilcoxon (Mann-Whitney)|||Comparison between groups for pain during treatment.||||0.0007
71116215|NCT02488135|141738839|SUPERIORITY|||||||0.0021|||||||Wilcoxon (Mann-Whitney)|||Comparison between scores for pain during removal.||||0.0021
71116216|NCT04091581|141738849|OTHER|||||||0.002|||||||ANOVA|||||||0.002
71116217|NCT04091581|141738849|OTHER|||||||0.022|||||||t-test, 2 sided|||Comparison of the baseline tear evaporation rate of the non-dry eye and dry eye group.||||0.022
71116218|NCT03724981|141738856|SUPERIORITY||||||<|0.0001|||||||Prescott test|||||||<0.0001
71116219|NCT03724981|141738857|SUPERIORITY||||||<|0.0001|||||||Prescott test|||||||<0.0001
71116220|NCT01005316|141738934|SUPERIORITY_OR_OTHER|||||||0.258|||||||Fisher Exact|||The p-value compares Cohort A: Non-Sensitized with Cohort B: Sensitized, Crossmatch Positive.||||0.2580
71116221|NCT01074463|141738974|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|109.18|||||TWO_SIDED|90.0|99.25|120.12|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||120.12|99.25|
71116222|NCT01074463|141738975|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|104.06|||||TWO_SIDED|90.0|98.73|109.68|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||109.68|98.73|
71116223|NCT01074463|141738976|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.34|||||TWO_SIDED|90.0|97.78|107.11|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.11|97.78|
71116224|NCT01734395|141738977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19|STANDARD_DEVIATION|4.56|<|0.0001|TWO_SIDED|95.0|-1.4262|-0.9467|||t-test, 2 sided|||||-0.9467|-1.4262|<.0001
71116225|NCT01734395|141738978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.48|STANDARD_DEVIATION|10.69|<|0.0001|TWO_SIDED|95.0|0.9188|2.0438|||t-test, 2 sided|||||2.0438|0.9188|<.0001
71116226|NCT01734395|141738979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_DEVIATION|2.43|<|0.0001|TWO_SIDED|95.0|-0.814|-0.5586|||t-test, 2 sided|||||-0.5586|-0.814|<.0001
71116227|NCT00758264|141738995|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.87|||||TWO_SIDED|95.0|0.72|1.05||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 1 antibody concentrations.||1.05|0.72|
71116228|NCT00758264|141738995|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|1.03|||||TWO_SIDED|95.0|0.84|1.26||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 4 antibody concentrations.||1.26|0.84|
71116229|NCT00758264|141738995|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.9|||||TWO_SIDED|95.0|0.74|1.1||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 5 antibody concentrations.||1.10|0.74|
71117709|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-69.33|||<|0.001|TWO_SIDED|95.0|-84.96|-53.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-53.71|-84.96|<0.001
70940685|NCT03840148|141381464|OTHER||Miettinen and Nurminen|14.0|||||TWO_SIDED|95.0|3.8|24.3||||||||24.3|3.8|
70940686|NCT03840148|141381465|OTHER||Miettinen and Nurminen|7.7|||||TWO_SIDED|95.0|-1.9|17.7||||||||17.7|-1.9|
71116230|NCT00758264|141738995|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.84|||||TWO_SIDED|95.0|0.66|1.07||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 6B antibody concentrations.||1.07|0.66|
71116231|NCT00758264|141738995|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|1.0|||||TWO_SIDED|95.0|0.84|1.2||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 7F antibody concentrations.||1.20|0.84|
71116232|NCT00758264|141738995|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.94|||||TWO_SIDED|95.0|0.78|1.14||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 9V antibody concentrations.||1.14|0.78|
71116233|NCT00758264|141738995|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.98|||||TWO_SIDED|95.0|0.78|1.23||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 14 antibody concentrations.||1.23|0.78|
71116234|NCT00758264|141738995|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.52|||||TWO_SIDED|95.0|0.41|0.67||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 18C antibody concentrations.||0.67|0.41|
71116235|NCT00758264|141738995|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.86|||||TWO_SIDED|95.0|0.68|1.08||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 19F antibody concentrations.||1.08|0.68|
71074792|NCT05153148|141658598|SUPERIORITY||Treatment Difference|-0.5|||=|0.131|TWO_SIDED|95.0|-1.2|0.2|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.2|-1.2|=0.131
71074793|NCT05153148|141658598|SUPERIORITY||Treatment Difference|-0.7|||=|0.043|TWO_SIDED|95.0|-1.3|0.0|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.0|-1.3|=0.043
71116236|NCT00758264|141738995|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|1.07|||||TWO_SIDED|95.0|0.83|1.38||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 23F antibody concentrations.||1.38|0.83|
71117710|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-65.19|||<|0.001|TWO_SIDED|95.0|-81.03|-49.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-49.34|-81.03|<0.001
70940687|NCT03840148|141381470|OTHER||Miettinen and Nurminen|14.0|||||TWO_SIDED|95.0|3.8|24.3||||||||24.3|3.8|
70940688|NCT03840148|141381472|OTHER||Miettinen and Nurminen|1.7|||||TWO_SIDED|95.0|-3.1|7.3||||||||7.3|-3.1|
70940689|NCT03840148|141381473|OTHER||Miettinen and Nurminen|4.8|||||TWO_SIDED|95.0|-1.1|11.5||||||||11.5|-1.1|
70940690|NCT03840148|141381474|OTHER||Miettinen and Nurminen|8.2|||||TWO_SIDED|95.0|1.2|15.7||||||||15.7|1.2|
70940691|NCT02577315|141381508|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|100.1|||||TWO_SIDED|90.0|97.466|102.804|||ANOVA|Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.|Relative bioavailability of Empagliflozin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination||102.804|97.466|
71116237|NCT00758264|141738996|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference in percentage of subjects with serum bactericidal antibody using baby rabbit complement against Neisseria meningitides serogroup A (rSBA-MenA) titer ≥ 1:8 (Nimenrix + Synflorix Group minus Nimenrix Group) is ≥ -10%.|Difference in percentage|1.93|||||TWO_SIDED|95.0|-1.09|8.15||||||Demonstration of non-inferiority of Nimenrix conjugate vaccine when co-administered with Synflorix vaccine versus Nimenrix conjugate vaccine given alone (Synflorix vaccine was administered 1 month later) in terms of serum bactericidal assay using rabbit complement against Neisseria meningitides serogroup A (rSBA-MenA).||8.15|-1.09|
71116238|NCT00758264|141738996|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference in percentage of subjects with serum bactericidal antibody using baby rabbit complement against Neisseria meningitides serogroup C (rSBA-MenC) titer ≥ 1:8 (Nimenrix + Synflorix Group minus Nimenrix Group) is ≥ -10%.|Difference in percentage|0.68|||||TWO_SIDED|95.0|-2.11|6.22||||||Demonstration of non-inferiority of Nimenrix conjugate vaccine when co-administered with Synflorix vaccine versus Nimenrix conjugate vaccine given alone (Synflorix vaccine was administered 1 month later) in terms of serum bactericidal assay using rabbit complement against Neisseria meningitides serogroup C (rSBA-MenC).||6.22|-2.11|
70853496|NCT01375075|141195101|SUPERIORITY_OR_OTHER||LS Mean Difference|-76.93|STANDARD_ERROR_OF_MEAN|6.02|<|0.001|TWO_SIDED|90.0|-86.89|-66.97||The P-value is for percent change from baseline in plasma CETP activity at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-66.97|-86.89|<0.001
70853497|NCT01375075|141195101|SUPERIORITY_OR_OTHER||LS Mean Difference|-90.81|STANDARD_ERROR_OF_MEAN|6.08|<|0.001|TWO_SIDED|90.0|-100.87|-80.75||The P-value is for percent change from baseline in plasma CETP activity at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-80.75|-100.87|<0.001
70853498|NCT01375075|141195101|SUPERIORITY_OR_OTHER||LS Mean Difference|-67.25|STANDARD_ERROR_OF_MEAN|5.96|<|0.001|TWO_SIDED|90.0|-77.12|-57.39||The P-value is for percent change from baseline in plasma CETP activity at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-57.39|-77.12|<0.001
70853499|NCT01375075|141195101|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.6|STANDARD_ERROR_OF_MEAN|6.21|<|0.001|TWO_SIDED|90.0|-52.88|-32.33||The P-value is for percent change from baseline in plasma CETP activity at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-32.33|-52.88|<0.001
70853500|NCT01375075|141195101|SUPERIORITY_OR_OTHER||LS Mean Difference|-78.93|STANDARD_ERROR_OF_MEAN|6.17|<|0.001|TWO_SIDED|90.0|-89.15|-68.71||The P-value is for percent change from baseline in plasma CETP activity at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-68.71|-89.15|<0.001
70853501|NCT01375075|141195101|SUPERIORITY_OR_OTHER||LS Mean Difference|-93.67|STANDARD_ERROR_OF_MEAN|6.29|<|0.001|TWO_SIDED|90.0|-104.08|-83.26||The P-value is for percent change from baseline in plasma CETP activity at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-83.26|-104.08|<0.001
70853502|NCT01375075|141195101|SUPERIORITY_OR_OTHER||LS Mean Difference|-75.01|STANDARD_ERROR_OF_MEAN|6.31|<|0.001|TWO_SIDED|90.0|-85.46|-64.57||The P-value is for percent change from baseline in plasma CETP activity at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-64.57|-85.46|<0.001
70853503|NCT01375075|141195101|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.28|STANDARD_ERROR_OF_MEAN|4.98|<|0.001|TWO_SIDED|90.0|-58.53|-42.04||The P-value is for percent change from baseline in plasma CETP activity at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-42.04|-58.53|<0.001
70853504|NCT01375075|141195101|SUPERIORITY_OR_OTHER||LS Mean Difference|-83.07|STANDARD_ERROR_OF_MEAN|4.98|<|0.001|TWO_SIDED|90.0|-91.32|-74.83||The P-value is for percent change from baseline in plasma CETP activity at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-74.83|-91.32|<0.001
70853505|NCT01375075|141195101|SUPERIORITY_OR_OTHER||LS Mean Difference|-94.51|STANDARD_ERROR_OF_MEAN|5.08|<|0.001|TWO_SIDED|90.0|-102.92|-86.1||The P-value is for percent change from baseline in plasma CETP activity at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-86.10|-102.92|<0.001
70853506|NCT01375075|141195101|SUPERIORITY_OR_OTHER||LS Mean Difference|-67.68|STANDARD_ERROR_OF_MEAN|5.15|<|0.001|TWO_SIDED|90.0|-76.2|-59.16||The P-value is for percent change from baseline in plasma CETP activity at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-59.16|-76.20|<0.001
70853507|NCT01375075|141195102|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|90.0|1.38|2.21||The P-value is for change from baseline in plasma CETP mass at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.21|1.38|<0.001
70853508|NCT01375075|141195102|SUPERIORITY_OR_OTHER||LS Mean Difference|3.06|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|90.0|2.65|3.48||The P-value is for change from baseline in plasma CETP mass at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.48|2.65|<0.001
70853509|NCT01375075|141195102|SUPERIORITY_OR_OTHER||LS Mean Difference|3.46|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|90.0|3.04|3.88||The P-value is for change from baseline in plasma CETP mass at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.88|3.04|<0.001
70853510|NCT01375075|141195102|SUPERIORITY_OR_OTHER||LS Mean Difference|2.22|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|90.0|1.81|2.63||The P-value is for change from baseline in plasma CETP mass at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.63|1.81|<0.001
70853511|NCT01375075|141195102|SUPERIORITY_OR_OTHER||LS Mean Difference|1.88|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|90.0|1.4|2.36||The P-value is for change from baseline in plasma CETP mass at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.36|1.40|<0.001
70853512|NCT01375075|141195102|SUPERIORITY_OR_OTHER||LS Mean Difference|2.99|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|90.0|2.51|3.47||The P-value is for change from baseline in plasma CETP mass at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.47|2.51|<0.001
70853513|NCT01375075|141195102|SUPERIORITY_OR_OTHER||LS Mean Difference|3.92|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|90.0|3.42|4.41||The P-value is for change from baseline in plasma CETP mass at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||4.41|3.42|<0.001
70940692|NCT02577315|141381509|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|95.51|||||TWO_SIDED|90.0|89.29|102.16|||ANOVA|Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.|Relative bioavailability of Metformin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination||102.16|89.29|
70940693|NCT02577315|141381510|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|102.71|||||TWO_SIDED|90.0|97.309|108.413|||ANOVA|Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.|Relative bioavailability of Empagliflozin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination||108.413|97.309|
71116239|NCT00758264|141738996|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference in percentage of subjects with serum bactericidal antibody using baby rabbit complement against Neisseria meningitides serogroup W-135 (rSBA-MenW-135) titer ≥ 1:8 (Nimenrix + Synflorix Group minus Nimenrix Group) is ≥ -10%.|Difference in percentage|1.25|||||TWO_SIDED|95.0|-0.94|6.76||||||Demonstration of non-inferiority of Nimenrix conjugate vaccine when co-administered with Synflorix vaccine versus Nimenrix conjugate vaccine given alone (Synflorix vaccine was administered 1 month later) in terms of serum bactericidal assay using rabbit complement against Neisseria meningitides serogroup W-135 (rSBA-MenW-135).||6.76|-0.94|
71117711|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-10.61||||0.016|TWO_SIDED|95.0|-19.02|-2.19||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-2.19|-19.02|0.016
71117712|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-0.69||||0.895|TWO_SIDED|95.0|-10.69|9.32||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.32|-10.69|0.895
71117713|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-5.09||||0.308|TWO_SIDED|95.0|-14.8|4.62||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.62|-14.80|0.308
71117714|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-71.36|||<|0.001|TWO_SIDED|95.0|-86.58|-56.13||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-56.13|-86.58|<0.001
71117715|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-62.11|||<|0.001|TWO_SIDED|95.0|-78.04|-46.19||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-46.19|-78.04|<0.001
71117716|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-64.57|||<|0.001|TWO_SIDED|95.0|-80.64|-48.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-48.50|-80.64|<0.001
71117717|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-59.84|||<|0.001|TWO_SIDED|95.0|-76.12|-43.55||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-43.55|-76.12|<0.001
71117718|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-11.49||||0.028|TWO_SIDED|95.0|-21.63|-1.35||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-1.35|-21.63|0.028
71117719|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-1.88||||0.747|TWO_SIDED|95.0|-13.15|9.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.38|-13.15|0.747
71117720|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-5.88||||0.303|TWO_SIDED|95.0|-16.88|5.12||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||5.12|-16.88|0.303
70940694|NCT02577315|141381511|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|101.07|||||TWO_SIDED|90.0|95.565|106.902|||ANOVA|Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.|Relative bioavailability of Metformin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination||106.902|95.565|
70940695|NCT02577315|141381512|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|100.3|||||TWO_SIDED|90.0|97.532|103.149|||ANOVA|Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.|Relative bioavailability of Empagliflozin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination||103.149|97.532|
70940696|NCT02577315|141381513|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|93.55|||||TWO_SIDED|90.0|82.86|105.61|||ANOVA|Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.|Relative bioavailability of Metformin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination||105.61|82.86|
70940697|NCT01178281|141381538|OTHER|||||||1|||||||Fisher Exact|||||||1.000
70940698|NCT01178281|141381540|OTHER|||||||0.929|||||||Log Rank|||||||0.929
70940699|NCT04050722|141381559|SUPERIORITY||Adjusted Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.08|-0.04||Analysis was performed using ANCOVA model with study product group, gender, and baseline MGI stratification (low/high) as factors and the baseline value as covariate.|ANCOVA|||||-0.04|-0.08|<0.0001
70940700|NCT00443755|141381571|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
70853514|NCT01375075|141195102|SUPERIORITY_OR_OTHER||LS Mean Difference|2.04|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|90.0|1.56|2.52||The P-value is for change from baseline in plasma CETP mass at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.52|1.56|<0.001
70940701|NCT00443755|141381572|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
70940702|NCT00443755|141381573|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.02
70853515|NCT01375075|141195102|SUPERIORITY_OR_OTHER||LS Mean Difference|1.82|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|90.0|1.34|2.31||The P-value is for change from baseline in plasma CETP mass at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.31|1.34|<0.001
70853516|NCT01375075|141195102|SUPERIORITY_OR_OTHER||LS Mean Difference|2.83|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|90.0|2.34|3.31||The P-value is for change from baseline in plasma CETP mass at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.31|2.34|<0.001
70853517|NCT01375075|141195102|SUPERIORITY_OR_OTHER||LS Mean Difference|3.24|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|90.0|2.74|3.73||The P-value is for change from baseline in plasma CETP mass at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.73|2.74|<0.001
70940703|NCT00443755|141381574|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
70940704|NCT00443755|141381575|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||P-value is for comparison between groups of the mean change in triglyceride levels.||||0.03
70940705|NCT00443755|141381575|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Wilcoxon (Mann-Whitney)|||P-value is for comparison between groups of the mean change in HDL-C levels.||||0.06
70940706|NCT00443755|141381575|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Wilcoxon (Mann-Whitney)|||P-value is for comparison between groups of mean change in non-HDL-C levels.||||0.06
70940707|NCT00443755|141381576|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.23
70940708|NCT00443755|141381577|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
70940709|NCT00443755|141381578|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.13
70940710|NCT00443755|141381579|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
71074794|NCT05153148|141658598|SUPERIORITY||Treatment Difference|-0.1|||=|0.687|TWO_SIDED|95.0|-0.8|0.5|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.5|-0.8|=0.687
70940711|NCT00443755|141381580|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.02
70940712|NCT00443755|141381581|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
70940713|NCT00443755|141381582|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.006
70940714|NCT00443755|141381583|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.18
70940715|NCT00443755|141381584|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.76
70941974|NCT00088452|141384310|SUPERIORITY||Odds Ratio (OR)|2.66|||<|0.001|TWO_SIDED|95.0|1.65|4.28|||Chi-squared||odds ratio with ethosuximide vs. lamotrigine|Calculations of sample size were based on the ability to detect a 20% difference in freedom-from failure rates (three pairwise comparisons) at 16 weeks with 80% power at a two-sided P value of 0.017 and one interim analysis. Sample size of 398 was increased to 446 subjects to account for two stratification factors and a 5% dropout rate; this sample size allowed the detection of a difference of 0.5 SD in the Confidence Index on the Conners' Continuous Performance Test with a power exceeding 80%.||4.28|1.65|<0.001
71074795|NCT05153148|141658599|SUPERIORITY||Risk Difference (RD)|5.6|||=|0.349|TWO_SIDED|95.0|-6.1|17.4|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of MDA responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|17.4|-6.1|=0.349
70853518|NCT01375075|141195102|SUPERIORITY_OR_OTHER||LS Mean Difference|2.14|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|90.0|1.65|2.63||The P-value is for change from baseline in plasma CETP mass at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.63|1.65|<0.001
70853519|NCT01375075|141195103|SUPERIORITY_OR_OTHER||LS Mean Difference|74.23|STANDARD_ERROR_OF_MEAN|12.59|<|0.001|TWO_SIDED|90.0|53.38|95.07||The P-value is for percent change from baseline in HDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.||95.07|53.38|<0.001
70853520|NCT01375075|141195103|SUPERIORITY_OR_OTHER||LS Mean Difference|115.36|STANDARD_ERROR_OF_MEAN|12.55|<|0.001|TWO_SIDED|90.0|94.58|136.14||The P-value is for percent change from baseline in HDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.||136.14|94.58|<0.001
70853521|NCT01375075|141195103|SUPERIORITY_OR_OTHER||LS Mean Difference|135.57|STANDARD_ERROR_OF_MEAN|12.72|<|0.001|TWO_SIDED|90.0|114.5|156.63||The P-value is for percent change from baseline in HDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.||156.63|114.50|<0.001
70853522|NCT01375075|141195103|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.47|STANDARD_ERROR_OF_MEAN|4.85||0.002|TWO_SIDED|90.0|-23.5|-7.43||The P-value is for percent change from baseline in LDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.||-7.43|-23.50|0.002
70853523|NCT01375075|141195103|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.37|STANDARD_ERROR_OF_MEAN|4.83|<|0.001|TWO_SIDED|90.0|-31.37|-15.38||The P-value is for percent change from baseline in LDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.||-15.38|-31.37|<0.001
70853524|NCT01375075|141195103|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.19|STANDARD_ERROR_OF_MEAN|4.91|<|0.001|TWO_SIDED|90.0|-30.32|-14.06||The P-value is for percent change from baseline in LDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.||-14.06|-30.32|<0.001
70853525|NCT01375075|141195103|SUPERIORITY_OR_OTHER||LS Mean Difference|103.25|STANDARD_ERROR_OF_MEAN|12.64|<|0.001|TWO_SIDED|90.0|82.32|124.18||The P-value is for percent change from baseline in HDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||124.18|82.32|<0.001
70853526|NCT01375075|141195103|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.63|STANDARD_ERROR_OF_MEAN|4.88||0.003|TWO_SIDED|90.0|-22.72|-6.55||The P-value is for percent change from baseline in LDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-6.55|-22.72|0.003
70853527|NCT03207035|141195107|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
71116240|NCT00758264|141738996|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference in percentage of subjects with serum bactericidal antibody using baby rabbit complement against Neisseria meningitides serogroup Y (rSBA-MenY) titer ≥ 1:8 (Nimenrix + Synflorix Group minus Nimenrix Group) is ≥ -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.18|4.6||||||Demonstration of non-inferiority of Nimenrix conjugate vaccine when co-administered with Synflorix vaccine versus Nimenrix conjugate vaccine given alone (Synflorix vaccine was administered 1 month later) in terms of serum bactericidal assay using rabbit complement against Neisseria meningitides serogroup Y (rSBA-MenY).||4.6|-2.18|
70853528|NCT03207035|141195108|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
70853529|NCT03207035|141195109|OTHER|||||||0.7|||||||t-test, 2 sided|||||||0.70
70853530|NCT03207035|141195110|OTHER|||||||0.002|||||||t-test, 2 sided|||||||0.002
70853531|NCT03207035|141195111|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
70853532|NCT03207035|141195112|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
70853533|NCT03207035|141195113|OTHER|||||||0.53|||||||Chi-squared|||||||0.53
70853534|NCT03207035|141195114|OTHER|||||||0.48|||||||Chi-squared|||||||0.48
70853535|NCT01252732|141195122|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority hypothesis test is a one sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two-sided 95% CI for the difference in response rates in the mITT population is greater than -10% the NI of oritavancin to vancomycin is concluded.|Difference in Proportions|-2.7|||||TWO_SIDED|95.0|-7.5|2.0||||||||2.0|-7.5|
70853536|NCT01252732|141195123|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority hypothesis test is a one sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two-sided 95% CI for the difference in response rates in the mITT population is greater than -10% the NI of oritavancin to vancomycin is concluded.|Difference in Proportions|2.2|||||TWO_SIDED|95.0|-2.6|7.0||||||||7.0|-2.6|
70853537|NCT01252732|141195124|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority hypothesis test is a one sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two-sided 95% CI for the difference in response rates in the mITT population is greater than -10% the NI of oritavancin to vancomycin is concluded.|Difference in Proportions|0.6|||||TWO_SIDED|95.0|-3.7|5.0||||||||5.0|-3.7|
70853538|NCT04236141|141195129|SUPERIORITY||Difference in Response Rates|10.71|||||TWO_SIDED|95.0|-19.0|40.43||||||||40.43|-19.00|
71116241|NCT02300558|141739026|OTHER|||||||0.0087|||||||paired t- test|||Based on a 2-sided, paired t-test ( α = 0.05), and a standard deviation (SD) of 30 msec, a sample size of 40 participants provided greater than 95% power assuming a difference in mean daytime QTcF interval (AUC0-6/6) as measured by standard 12-lead ECG between baseline and Week 24 of 20 msec. The null hypothesis was that the mean difference between the baseline and Week 24 mean daytime QTcF interval was zero.||||0.0087
71116242|NCT03888235|141739041|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||The null hypothesis assumes that after one month, there is no difference in Oswestry low back pain and disability score improvement between the three treatment groups.||||0.003
71074796|NCT05153148|141658599|SUPERIORITY||Risk Difference (RD)|15.5|||=|0.017|TWO_SIDED|95.0|2.8|28.3|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of MDA responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|28.3|2.8|=0.017
71116243|NCT03888235|141739041|SUPERIORITY|||||||0.001||||||SI Exercise versus usual care. Bonferroni alpha correction p\< 0.0167|Wilcoxon (Mann-Whitney)|||||||0.001
71116244|NCT03888235|141739041|SUPERIORITY|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: there is no difference in Oswestry low back pain and disability score between those using a pelvic support belt and those using usual treatment||||0.314
71116245|NCT03888235|141739042|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||Oswestry low back pain and disability (ODI) score change over two months for all participants. This compares the score at initial visit and the score 2 months later after all participants have been using the corrective exercise and sacroiliac stabilization belt for one month. =(ODI time 0 - ODI 2 months). The greater the difference, the better the recovery of back function.||||< 0.001
71116246|NCT03888235|141739043|SUPERIORITY|||||||0.17|||||||Kruskal-Wallis|||The null hypothesis assumes that after one month, there is no difference in brief pain inventory score improvement between the three treatment groups.||||0.17
71116247|NCT03888235|141739043|SUPERIORITY|||||||0.089||||||Bonferroni alpha correction of p\<0.0167.|Wilcoxon (Mann-Whitney)|||The brief pain inventory score at the one month visit, is used to compare the pain levels of those having done one month of corrective exercises to those who continued with conventional treatments for their low back pain.||||0.089
71074797|NCT05153148|141658599|SUPERIORITY||Risk Difference (RD)|16.3|||=|0.014|TWO_SIDED|95.0|3.3|29.3|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of MDA responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|29.3|3.3|=0.014
71074798|NCT05153148|141658600|SUPERIORITY||Treatment Difference|-3.73|||=|0.167|TWO_SIDED|95.0|-9.04|1.57|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|1.57|-9.04|=0.167
70853539|NCT04236141|141195130|SUPERIORITY||Difference in Response Rates|7.14|||||TWO_SIDED|95.0|-22.03|36.31||||||||36.31|-22.03|
70853540|NCT04236141|141195131|SUPERIORITY||Difference in Response Rates|14.29|||||TWO_SIDED|95.0|-15.89|44.46||||||||44.46|-15.89|
71116248|NCT03888235|141739043|SUPERIORITY|||||||0.092|||||||Wilcoxon (Mann-Whitney)|||The brief pain inventory score is used to compare those using a pelvic support belt for one month and those with delayed treatment||||0.092
71116249|NCT03888235|141739044|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||All participants are assessed as a single group as they receive the same two treatments for one month. Brief pain inventory (BPI) score change over two months for all participants. This compares BPI score at baseline visit and BPI score 2 months later, after all participants have been using the corrective exercise and sacroiliac stabilization belt for one month. The score is between 0 and 10. The higher the change in score the greater the pain relief.||||< 0.001
71116250|NCT03888235|141739045|SUPERIORITY|||||||0.016||||||The Bonferroni alpha correction is used p\<0.0167|Kruskal-Wallis|||The null hypothesis assumes there is no improvement after one month in posterior superior iliac spine levels (PSISL) measured using the sacroiliac forward flexion test (SIFFT) between the three treatment groups.||||0.016
71116251|NCT03888235|141739045|SUPERIORITY|||||||0.009||||||The Bonferroni alpha correction is used p\<0.0167|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the distance between the posterior sacroiliac spine levels (PSISL) between those who use their usual low back pain treatments and those who are given the corrective exercises (SIFFTE) and use them as needed for one month.||||0.009
71116252|NCT03888235|141739045|SUPERIORITY|||||||0.034||||||Bonferroni correction p\< 0.0167|Wilcoxon (Mann-Whitney)|||The null hypothesis is that that using a pelvic support belt will not help correct sacroiliac joint asymmetry as measured using the distance between the posterior superior iliac spine levels (PSISL), baseline and one month later better than conventional treatment for low back pain.||||0.034
70940716|NCT00376935|141381590|SUPERIORITY_OR_OTHER_LEGACY||Shift parameter|-9.0||||0.1996|ONE_SIDED|98.4||14.0||P-value reported here was not adjusted for multiple comparisons. A 98.4% confidence upper bound for the shift parameter for each comparison adjusted the multiple comparison issues and restricted the familywise Type I error rate at 0.05.|Wilcoxon (Mann-Whitney)|One-sided Wilcoxon rank sum test was used to test the null hypothesis.A 98.4% confidence upper bound for the primary shift parameter was calculated.|The shift parameter (say, X), was calculated as the difference between the distribution of the primary endpoint in the placebo arm and that of in the palifermin arm. X\<0 indicates that palifermen is beneficial.|The null hypothesis is that the distribution of the change in absolute CD4+ lymphocyte counts from baseline to week 12 is the same in the placebo arm and palifermin (20 mcg/kg) arm. The 1-sided alternative hypothesis is that the endpoint distribution is shifted higher in the palifermin (20 mcg/kg) arm.||14||0.1996
70940717|NCT00376935|141381590|SUPERIORITY_OR_OTHER_LEGACY||Shift parameter|-4.0||||0.3135|ONE_SIDED|98.4||17.0||P-value reported here was not adjusted for multiple comparisons. A 98.4% confidence upper bound for the shift parameter for each comparison adjusted the multiple comparison issues and restricted the familywise Type I error rate at 0.05.|Wilcoxon (Mann-Whitney)|One-sided Wilcoxon rank sum test was used to test the null hypothesis.A 98.4% confidence upper bound for the primary shift parameter was calculated.|The shift parameter (say, X), was calculated as the difference between the distribution of the primary endpoint in the placebo arm and that of in the palifermin arm. X\<0 indicates that palifermen is beneficial.|The null hypothesis is that the distribution of the change in absolute CD4+ lymphocyte counts from baseline to week 12 is the same in the placebo arm and palifermin (40 mcg/kg) arm. The 1-sided alternative hypothesis is that the endpoint distribution is shifted higher in the palifermin (40 mcg/kg) arm.||17||0.3135
70940718|NCT00376935|141381590|SUPERIORITY_OR_OTHER_LEGACY||Shift parameter|-4.0||||0.3662|ONE_SIDED|98.4||22.0||P-value reported here was not adjusted for multiple comparisons. A 98.4% confidence upper bound for the shift parameter for each comparison adjusted the multiple comparison issues and restricted the familywise Type I error rate at 0.05.|Wilcoxon (Mann-Whitney)|One-sided Wilcoxon rank sum test was used to test the null hypothesis.A 98.4% confidence upper bound for the primary shift parameter was calculated.|The shift parameter (say, X), was calculated as the difference between the distribution of the primary endpoint in the placebo arm and that of in the palifermin arm. X\<0 indicates that palifermen is beneficial.|The null hypothesis is that the distribution of the change in absolute CD4+ lymphocyte counts from baseline to week 12 is the same in the placebo arm and palifermin (60 mcg/kg) arm. The 1-sided alternative hypothesis is that the endpoint distribution is shifted higher in the palifermin (60 mcg/kg) arm.||22||0.3662
70940719|NCT05129592|141381614|SUPERIORITY||Mean Difference (Final Values)|15.71|STANDARD_ERROR_OF_MEAN|7.3||0.095|TWO_SIDED|95.0|-1.87|33.3||Sidak's adjusted p-value contrasting marginal linear predictions for the Nicotine corrective control and Nicotine corrective with both components of coherence|ANCOVA|Controlling for baseline nicotine misperception (df=4)|Comparing Nicotine corrective control to the Nicotine corrective with both components of coherence|||33.30|-1.87|0.095
71074799|NCT05153148|141658600|SUPERIORITY||Treatment Difference|-6.43|||=|0.018|TWO_SIDED|95.0|-11.73|-1.13|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|-1.13|-11.73|=0.018
71074800|NCT05153148|141658600|SUPERIORITY||Treatment Difference|-5.23|||=|0.056|TWO_SIDED|95.0|-10.59|0.13|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.13|-10.59|=0.056
71074801|NCT05153148|141658601|SUPERIORITY||Risk Difference (RD)|11.9|||=|0.186|TWO_SIDED|95.0|-5.7|29.4|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of PASI-75 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|29.4|-5.7|=0.186
71074802|NCT05153148|141658601|SUPERIORITY||Risk Difference (RD)|14.6|||=|0.101|TWO_SIDED|95.0|-2.8|32.1|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of PASI-75 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|32.1|-2.8|=0.101
71074803|NCT05153148|141658601|SUPERIORITY||Risk Difference (RD)|29.0|||=|0.002|TWO_SIDED|95.0|10.5|47.6|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of PASI-75 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|47.6|10.5|=0.002
71074804|NCT05153148|141658602|SUPERIORITY||Risk Difference (RD)|4.5|||=|0.54|TWO_SIDED|95.0|-10.0|19.0|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of PhGA-PSO responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|19.0|-10.0|=0.540
71116253|NCT03888235|141739046|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Since all participants have received the same 2 treatment for one month, we will treat them as a single group. We will measure the distance between their posterior superior iliac spine levels (PSISL) when they enter the study and two months later after they have used the corrective exercise and the sacroiliac belt for one month. Corona prevented some participants from returning for examination, which this test requires. Only 11 participants were present in each group: 33 participants tested.||||< 0.0001
71116254|NCT03888235|141739046|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||< 0.001
70853541|NCT04236141|141195132|SUPERIORITY||Difference in Response Rates|21.43|||||TWO_SIDED|95.0|-9.44|52.3||||||||52.30|-9.44|
70940720|NCT05129592|141381614|SUPERIORITY||Mean Difference (Final Values)|18.67|STANDARD_ERROR_OF_MEAN|7.3||0.022|TWO_SIDED|95.0|2.02|35.33||Sidak's adjustment for multiple comparisons|ANCOVA|Controlling for baseline nicotine misperception (df=4)|Comparing Nicotine corrective control to the Nicotine corrective with both components of coherence|Sidak's adjusted p-value contrasting marginal linear predictions for the Nicotine corrective with causal explanation and Nicotine corrective with both components of coherence||35.33|2.02|0.022
70940721|NCT05129592|141381614|SUPERIORITY||Mean Difference (Final Values)|3.69|STANDARD_ERROR_OF_MEAN|7.3||0.931|TWO_SIDED|95.0|-12.76|20.15||Sidak's adjustment for multiple comparisons|ANCOVA|Controlling for baseline nicotine misperception (df=4)|Comparing Nicotine corrective with reason for misperception to the Nicotine corrective with both components of coherence|Sidak's adjusted p-value contrasting marginal linear predictions for the Nicotine corrective with reason for misperception and Nicotine corrective with both components of coherence||20.15|-12.76|0.931
70940722|NCT05129592|141381615|SUPERIORITY||Odds Ratio (OR)|1.54||||0.402|TWO_SIDED|95.0|0.56|4.24|||Regression, Logistic||Odds of believing e-cigarettes are less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing e-cigarettes are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on e-cigarette relative harm beliefs||4.24|0.56|0.402
70940723|NCT05129592|141381615|SUPERIORITY||Odds Ratio (OR)|1.83||||0.292|TWO_SIDED|95.0|0.59|5.62|||Regression, Logistic||Odds of believing e-cigarettes are somewhat or much less harmful than cigarettes in the control condition/odds of believing e-cigarettes are somewhat or much less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on e-cigarette relative harm beliefs||5.62|0.59|0.292
70940724|NCT05129592|141381615|SUPERIORITY||Odds Ratio (OR)|0.77||||0.571|TWO_SIDED|95.0|0.3|1.93|||Regression, Logistic||Odds of believing e-cigarettes are less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing e-cigarettes are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on e-cigarette relative harm beliefs||1.93|0.30|0.571
70940725|NCT05129592|141381615|SUPERIORITY||Odds Ratio (OR)|1.98|STANDARD_ERROR_OF_MEAN|1.44||0.349|TWO_SIDED|95.0|0.47|8.26|||Regression, Logistic||Odds of believing e-cigarettes are less harmful than cigarettes in the control condition/odds of believing e-cigarettes are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on e-cigarette relative harm beliefs controlling for baseline beliefs and e-cigarette use||8.26|0.47|0.349
70940726|NCT05129592|141381615|SUPERIORITY||Odds Ratio (OR)|1.76|STANDARD_ERROR_OF_MEAN|1.07||0.355|TWO_SIDED|95.0|0.53|5.81|||Regression, Logistic||Odds of believing e-cigarettes are less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing e-cigarettes are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on e-cigarette relative harm beliefs controlling for baseline beliefs and e-cigarette use||5.81|0.53|0.355
70940727|NCT05129592|141381615|SUPERIORITY||Odds Ratio (OR)|0.74|STANDARD_ERROR_OF_MEAN|0.42||0.591|TWO_SIDED|95.0|0.24|2.25|||Regression, Logistic||Odds of believing e-cigarettes are less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing e-cigarettes are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on e-cigarette relative harm beliefs controlling for baseline beliefs and e-cigarette use||2.25|0.24|0.591
71074805|NCT05153148|141658602|SUPERIORITY||Risk Difference (RD)|5.2|||=|0.466|TWO_SIDED|95.0|-8.8|19.3|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of PhGA-PSO responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|19.3|-8.8|=0.466
71074806|NCT05153148|141658602|SUPERIORITY||Risk Difference (RD)|16.3|||=|0.034|TWO_SIDED|95.0|1.2|31.3|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of PhGA-PSO responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|31.3|1.2|=0.034
71074807|NCT01712334|141658605|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of the mean percent predicted FEV1 at the end of the eRapid treatment to the mean percent predicted FEV1 at the end of the LC Plus jet nebulizer treatment. The two nebulizers were considered equivalent if the 90% CI was within 80%-125%.|Ratio (Fieller's theorem)|100.9|||||TWO_SIDED|90.0|99.5|102.3||||||||102.3|99.5|
71074808|NCT01953432|141658607|OTHER||Odds Ratio (OR)|0.75|||||TWO_SIDED||||||||Probability of 0.75 that the OR exceeded 1.00 (OR = 1.01, 95% CI = 0.98-1.05)|||||
70940728|NCT05129592|141381616|SUPERIORITY|Unadjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on NRT relative harm beliefs|Odds Ratio (OR)|0.98|STANDARD_ERROR_OF_MEAN|0.99||0.98|TWO_SIDED|95.0|0.13|7.27|||Regression, Logistic||Odds of believing NRT is less harmful than cigarettes in the control condition/odds of believing NRT is less harmful than cigarettes in the condition with both component of coherence|||7.27|0.13|0.980
70853542|NCT04236141|141195133|SUPERIORITY||Difference in Response Rates|17.86|||||TWO_SIDED|95.0|-1.69|37.4||||||||37.40|-1.69|
70940729|NCT05129592|141381616|SUPERIORITY||Odds Ratio (OR)|0.47|STANDARD_ERROR_OF_MEAN|0.41||0.382|TWO_SIDED|95.0|0.09|2.56|||Regression, Logistic||Odds of believing NRT is less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing NRT is less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on NRT relative harm beliefs||2.56|0.09|0.382
70940730|NCT05129592|141381616|SUPERIORITY||Odds Ratio, log|0.83|STANDARD_ERROR_OF_MEAN|0.79||0.846|TWO_SIDED|95.0|0.13|5.23|||Regression, Logistic||Odds of believing NRT is less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing NRT is less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on NRT relative harm beliefs||5.23|0.13|0.846
71074809|NCT01953432|141658607|OTHER||Odds Ratio (OR)|0.96|||||TWO_SIDED||||||||Probability of 0.96 that the odds ratio exceeded 1.00 (OR = 1.03, 95% CI = 1.00-1.07)|||||
71074810|NCT02892513|141658608|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
71074811|NCT02407054|141658613|SUPERIORITY||Hazard Ratio (HR)|0.5871|||||TWO_SIDED|95.0|0.3967|0.869||||||||0.8690|0.3967|
70853543|NCT04236141|141195134|SUPERIORITY||Difference in Response Rates|17.86|||||TWO_SIDED|95.0|-1.69|37.4||||||||37.40|-1.69|
70853544|NCT04236141|141195135|SUPERIORITY||Difference in Response Rates|17.86|||||TWO_SIDED|95.0|-12.7|48.42||||||||48.42|-12.70|
71074812|NCT02407054|141658614|SUPERIORITY||Hazard Ratio (HR)|0.6515|||||TWO_SIDED|95.0|0.4123|1.0294||||||||1.0294|0.4123|
71074813|NCT02044874|141658625|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.02||||0.0027|TWO_SIDED|95.0|1.47|6.22|||Regression, Logistic|||||6.22|1.47|0.0027
71074814|NCT02044874|141658625|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.2427|TWO_SIDED|95.0|0.73|3.51|||Regression, Logistic|||||3.51|0.73|0.2427
70853545|NCT04236141|141195136|SUPERIORITY||Difference in Response Rates|14.29|||||TWO_SIDED|95.0|-15.89|44.46||||||||44.46|-15.89|
71074815|NCT02044874|141658625|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.89||||0.0477|TWO_SIDED|95.0|1.01|3.56|||Regression, Logistic|||||3.56|1.01|0.0477
71074816|NCT02044874|141658626|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.84||||0.0784|TWO_SIDED|95.0|0.89|9.08|||Regression, Logistic|||||9.08|0.89|0.0784
71074817|NCT02044874|141658626|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.78||||0.365|TWO_SIDED|95.0|0.51|6.17|||Regression, Logistic|||||6.17|0.51|0.3650
71074818|NCT02044874|141658626|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.3438|TWO_SIDED|95.0|0.61|4.21|||Regression, Logistic|||||4.21|0.61|0.3438
71074819|NCT02044874|141658627|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92||||0.0379|TWO_SIDED|95.0|1.04|3.55|||Regression, Logistic|||||3.55|1.04|0.0379
71074820|NCT02044874|141658627|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.8628|TWO_SIDED|95.0|0.54|2.09|||Regression, Logistic|||||2.09|0.54|0.8628
71074821|NCT02044874|141658627|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.0556|TWO_SIDED|95.0|0.99|3.31|||Regression, Logistic|||||3.31|0.99|0.0556
71074822|NCT02044874|141658628|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92||||0.0219|TWO_SIDED|95.0|1.1|3.35|||Regression, Logistic|||||3.35|1.10|0.0219
71074823|NCT02044874|141658628|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.545|TWO_SIDED|95.0|0.66|2.18|||Regression, Logistic|||||2.18|0.66|0.5450
71074824|NCT02044874|141658628|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.0868|TWO_SIDED|95.0|0.93|2.72|||Regression, Logistic|||||2.72|0.93|0.0868
71074825|NCT02044874|141658629|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.97||||0.0004|TWO_SIDED|95.0|-1.51|-0.43|||Mixed-effects repeated measures|||||-0.43|-1.51|0.0004
71074826|NCT02044874|141658629|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.34||||0.2268|TWO_SIDED|95.0|-0.89|0.21|||mixed effects repeated measures|||||0.21|-0.89|0.2268
71074827|NCT02044874|141658629|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.63||||0.0217|TWO_SIDED|95.0|-1.17|-0.09|||mixed effects repeated measures|||||-0.09|-1.17|0.0217
71074828|NCT00415597|141658631|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||Null hypothesis: Percent change from baseline = 0||||<0.0001
71074829|NCT00415597|141658632|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||Null hypothesis: Percent change from baseline = 0||||<0.0001
71074830|NCT01447927|141658633|SUPERIORITY_OR_OTHER|||||||0.7981|||||||Wilcoxon Rank-Rum Test (1-sided)|||The null hypothesis was that the percent change in mean pS6K1 values (from pre to post) was the same or increased for the metformin arm as compared to placebo. Assuming equal standard deviations (i.e. 50%) across the metformin and placebo groups, 30 participants per arm yielded 84% power to detect at least a 35% decrease in the metformin arm as compared to placebo, using a 1-sided t-test with a significant level of 0.05.||||0.7981
71074831|NCT01650545|141658653|SUPERIORITY|||||||0.03|||||||Log Rank|||||||0.03
71078814|NCT01796301|141665658|SUPERIORITY||Treatment difference|3.4|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.6|4.2|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.||4.2|2.6|< 0.0001
71116255|NCT03888235|141739047|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||the null hypothesis is that all participants were as satisfied with the physiotherapy as they were with using the corrective exercises and the pelvic stabilization belt||||<0.00001
71116256|NCT03888235|141739048|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||the null hypothesis is that all participants were as satisfied with the acupuncture as they were with using the corrective exercises and the pelvic stabilization belt||||<0.00001
71116257|NCT03888235|141739049|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||The null hypothesis is that all participants were as satisfied with the yoga exercises as they were with using the corrective exercises and the pelvic stabilization belt||||<0.00001
71116258|NCT03888235|141739050|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||the null hypothesis is that all participants were as satisfied with the core exercises as they were with using the corrective exercise and the pelvic stabilization belt||||<0.00001
71116259|NCT03888235|141739051|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||the null hypothesis is that all participants were as satisfied with treatments by a chiropractor as they were with using the corrective exercise and the pelvic stabilization belt||||<0.00001
71116260|NCT03888235|141739052|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||The null hypothesis is that all participants were as satisfied with massage therapy as they were with using the corrective exercise and the pelvic stabilization belt.||||<0.00001
71116261|NCT00712725|141739088|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with PF at 2 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.||||||<0.001
71116262|NCT00712725|141739089|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with binary response PR at 2 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.||||||<0.001
71116263|NCT00712725|141739090|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with Absence of Photophobia at 2 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.||||||<0.001
70940731|NCT05129592|141381616|SUPERIORITY||Odds Ratio (OR)|1.01|STANDARD_ERROR_OF_MEAN|1.05||0.99|TWO_SIDED|95.0|0.13|7.74|||Regression, Logistic||Odds of believing NRT is less harmful than cigarettes in the control condition/odds of believing NRT is less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on NRT relative harm beliefs controlling for NRT use||7.74|0.13|0.990
70940732|NCT05129592|141381616|SUPERIORITY||Odds Ratio (OR)|0.51|STANDARD_ERROR_OF_MEAN|0.46||0.458|TWO_SIDED|95.0|0.09|3.01|||Regression, Logistic||Odds of believing NRT is less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing NRT is less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on NRT relative harm beliefs controlling for NRT use||3.01|0.09|0.458
71116264|NCT00712725|141739091|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with Absence of Phonophobia at 2 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.||||||<0.001
71116265|NCT00712725|141739092|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with Absence of Nausea at 2 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.||||||0.007
71116266|NCT00712725|141739093|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with binary response SPF 2-24 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.||||||<0.001
70853546|NCT04236141|141195137|SUPERIORITY||Difference in Response Rates|25.0|||||TWO_SIDED|95.0|-10.38|60.38||||||||60.38|-10.38|
70853547|NCT04236141|141195138|SUPERIORITY||Difference in Response Rates|3.57|||||TWO_SIDED|95.0|-33.84|40.98||||||||40.98|-33.84|
71116267|NCT03709277|141739097|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71116268|NCT03709277|141739098|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71116269|NCT03709277|141739100|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71116270|NCT00344318|141739101|NON_INFERIORITY_OR_EQUIVALENCE|Standardized asymptotic 95% confidence interval (CI) for the difference \[Synflorix™ minus Prevenar™\] in terms of percentages of subjects reporting rectal fever \>39.0°C after Dose 1 was computed.|Difference in percentage|2.17|||||TWO_SIDED|95.0|-1.51|4.88||||||Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever \>39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.||4.88|-1.51|
71074832|NCT02301039|141658734|SUPERIORITY|An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.|Binomial estimate of response rate of PR|17.5|||||TWO_SIDED|95.0|7.3|32.8|||||Clopper-Pearson (Exact) Confidence Interval. Excluded from rate due to no response evaluation: Soft Tissue: 2; Bone: 2; Expansion: 7 patients|An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.||32.8|7.3|
71074833|NCT02301039|141658734|SUPERIORITY||Binomial estimate of response rate of PR|5.0|||||TWO_SIDED|95.0|1.0|16.9|||||Clopper-Pearson exact confidence interval; Excluded from rate due to no response evaluation: Soft Tissue: 2; Bone: 2; Expansion: 7 patients|An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.||16.9|1.0|
71074834|NCT02301039|141658734|SUPERIORITY||Binomial estimate of response rate of PR|13.0|||||TWO_SIDED|95.0|5.5|25.3|||||Clopper-Pearson (Exact) Confidence Interval Excluded from rate due to no response evaluation: Soft Tissue: 2; Bone: 2; Expansion: 7 patients|An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.||25.3|5.5|
71074835|NCT03246061|141658800|SUPERIORITY||||||<|0.001||||||Interim Analysis p-value for significance of \<0.025 for an overall alpha of 0.05|ANCOVA|||Estimates and p-value from an ANCOVA with a factor of treatment group and a covariate of baseline ODI score. Values have been adjusted for multiple imputation. Note: 3 month visit is computed as post-treatment for the RF Ablation Arm, and post-randomization for the Control Arm.||||<0.001
71074836|NCT03246061|141658801|SUPERIORITY||||||<|0.001||||||Estimates and p-value from ANCOVA with a factor of treatment group and a covariate of baseline VAS score.|ANCOVA|||||||<0.001
71116271|NCT00344318|141739101|NON_INFERIORITY_OR_EQUIVALENCE|Towards this, standardized asymptotic 95% confidence interval (CI) for the difference \[Synflorix™ minus Prevenar™\] in terms of percentages of subjects reporting rectal fever \>39.0°C after Dose 2 was computed|Difference in percentage|-1.48||||||95.0|-6.05|1.92||||||Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever \>39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.||1.92|-6.05|
71116272|NCT00344318|141739101|NON_INFERIORITY_OR_EQUIVALENCE|Towards this, standardized asymptotic 95% confidence interval (CI) for the difference \[Synflorix™ minus Prevenar™\] in terms of percentages of subjects reporting rectal fever \>39.0°C after Dose 3 was computed.|Difference in percentage|3.05|||||TWO_SIDED|95.0|-1.02|6.19||||||Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever \>39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.||6.19|-1.02|
71074837|NCT05459558|141658829|SUPERIORITY||||||<|0.0001||||||p-value adjusted for multiplicity using Graphical Approach.|Mixed Model with Repeated Measures|||Test for non-zero within group change from Baseline.||||<0.0001
71074838|NCT05459558|141658829|SUPERIORITY||||||<|0.0001||||||p-value adjusted for multiplicity using Graphical Approach.|Mixed Model with Repeated Measures|||Test for non-zero within group change from Baseline.||||<0.0001
71074839|NCT05459558|141658830|SUPERIORITY||||||<|0.0001|||||||Mixed Models with Repeated Measures|||Test for non-zero within group change from Baseline.||||<0.0001
71116273|NCT00344318|141739101|NON_INFERIORITY_OR_EQUIVALENCE|Standardized asymptotic 95% confidence interval (CI) for the difference \[Synflorix™ minus Prevenar™\] in terms of percentages of subjects reporting rectal fever \>39.0°C across doses was computed.|Difference in percentage|3.13|||||TWO_SIDED|95.0|-2.65|8.01||||||Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever \>39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.||8.01|-2.65|
71116274|NCT05248997|141739150|SUPERIORITY||Difference in least square mean|-0.09||||0.7782|TWO_SIDED|95.0|-0.71|0.53||LM included baseline value as covariate,\& fixed effects for treatment group,stratification factor,scheduled time point(TP),TP by treatment group interaction.Repeated measures:modelled by unstructured covariance structure for within participant error.|Linear model (LM)|||||0.53|-0.71|0.7782
71116275|NCT05248997|141739151|SUPERIORITY||Difference in least square mean|-0.29||||0.7079|TWO_SIDED|95.0|-1.83|1.24||LM included baseline value as covariate, and fixed effects for treatment group,stratification factor,scheduled TP, TP by treatment group interaction.Repeated measures:modelled by unstructured covariance structure for within participant error.|Linear model (LM)|||||1.24|-1.83|0.7079
71074840|NCT05459558|141658830|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Test for non-zero within group change from Baseline.||||<0.0001
71074841|NCT05459558|141658831|SUPERIORITY||Mean Difference (Final Values)|-1.75|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-1.88|-1.62|||Mixed Model with Repeated Measures|||Week 4||-1.62|-1.88|<0.0001
71074842|NCT05459558|141658831|SUPERIORITY||Mean Difference (Final Values)|-1.74|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-1.87|-1.61|||Mixed Model with Repeated Measures|||Week 4||-1.61|-1.87|<0.0001
71074843|NCT05459558|141658831|SUPERIORITY||Mean Difference (Final Values)|-1.95|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001|TWO_SIDED|95.0|-2.08|-1.81||p-value adjusted for multiplicity using Graphical Approach.|Mixed Model with Repeated Measures|||Week 8||-1.81|-2.08|<0.0001
71074844|NCT05459558|141658831|SUPERIORITY||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001|TWO_SIDED|95.0|-2.18|-1.9||p-value adjusted for multiplicity using Graphical Approach.|Mixed Model with Repeated Measures|||Week 8||-1.90|-2.18|<0.0001
71074845|NCT05459558|141658832|SUPERIORITY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.097|<|0.0001|TWO_SIDED|95.0|-1.0|-0.62|||Mixed Model with Repeated Measures|||Week 4||-0.62|-1.00|<0.0001
71074846|NCT05459558|141658832|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.097|<|0.0001|TWO_SIDED|95.0|-0.79|-0.41|||Mixed Model with Repeated Measures|||Week 4||-0.41|-0.79|<0.0001
71074847|NCT05459558|141658832|SUPERIORITY||Mean Difference (Final Values)|-1.68|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-2.06|-1.31||p-value adjusted for multiplicity using Graphical Approach.|Mixed Model with Repeated Measures|||Week 8||-1.31|-2.06|<0.0001
71074848|NCT05459558|141658832|SUPERIORITY||Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|0.191|<|0.0001|TWO_SIDED|95.0|-2.19|-1.44||p-value adjusted for multiplicity using Graphical Approach.|Mixed Model with Repeated Measures|||Week 8||-1.44|-2.19|<0.0001
71074849|NCT05459558|141658833|SUPERIORITY||Mean Difference (Final Values)|-2.23|STANDARD_ERROR_OF_MEAN|0.092|<|0.0001|TWO_SIDED|95.0|-2.41|-2.05|||Mixed Model with Repeated Measures|||Gingival Sites, Week 4||-2.05|-2.41|<0.0001
71074850|NCT05459558|141658833|SUPERIORITY||Mean Difference (Final Values)|-2.23|STANDARD_ERROR_OF_MEAN|0.092|<|0.0001|TWO_SIDED|95.0|-2.41|-2.05|||Mixed Model with Repeated Measures|||Gingival Sites, Week 4||-2.05|-2.41|<0.0001
71074851|NCT05459558|141658833|SUPERIORITY||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|0.095|<|0.0001|TWO_SIDED|95.0|-2.69|-2.31|||Mixed Model with Repeated Measures|||Gingival Sites, Week 8||-2.31|-2.69|<0.0001
71074852|NCT05459558|141658833|SUPERIORITY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|0.095|<|0.0001|TWO_SIDED|95.0|-2.81|-2.44|||Mixed Model with Repeated Measures|||Gingival Sites, Week 8||-2.44|-2.81|<0.0001
71074853|NCT05459558|141658833|SUPERIORITY||Mean Difference (Final Values)|-2.06|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001|TWO_SIDED|95.0|-2.22|-1.91|||Mixed Model with Repeated Measures|||Interproximal Sites, Week 4||-1.91|-2.22|<0.0001
71074854|NCT05459558|141658833|SUPERIORITY||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001|TWO_SIDED|95.0|-2.2|-1.89|||Mixed Model with Repeated Measures|||Interproximal Sites, Week 4||-1.89|-2.20|<0.0001
71074855|NCT05459558|141658833|SUPERIORITY||Mean Difference (Final Values)|-2.29|STANDARD_ERROR_OF_MEAN|0.081|<|0.0001|TWO_SIDED|95.0|-2.45|-2.13|||Mixed Model with Repeated Measures|||Interproximal Sites, Week 8||-2.13|-2.45|<0.0001
71074856|NCT05459558|141658833|SUPERIORITY||Mean Difference (Final Values)|-2.41|STANDARD_ERROR_OF_MEAN|0.082|<|0.0001|TWO_SIDED|95.0|-2.57|-2.25|||Mixed Model with Repeated Measures|||Interproximal Sites, Week 8||-2.25|-2.57|<0.0001
71074857|NCT05459558|141658833|SUPERIORITY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.76|-0.5|||Mixed Model with Repeated Measures|||Body Sites, Week 4||-0.50|-0.76|<0.0001
71074858|NCT05459558|141658833|SUPERIORITY||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.77|-0.51|||Mixed Model with Repeated Measures|||Body Sites, Week 4||-0.51|-0.77|<0.0001
71116276|NCT05248997|141739152|SUPERIORITY||Difference in least square mean|-0.23||||0.4398|TWO_SIDED|95.0|-0.81|0.36||LM included baseline value as covariate, and fixed effects for treatment group,stratification factor,scheduled TP, TP by treatment group interaction.Repeated measures:modelled by unstructured covariance structure for within participant error.|Linear model (LM)|||||0.36|-0.81|0.4398
71074859|NCT05459558|141658833|SUPERIORITY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001|TWO_SIDED|95.0|-0.81|-0.57|||Mixed Model with Repeated Measures|||Body Sites, Week 8||-0.57|-0.81|<0.0001
71074860|NCT05459558|141658833|SUPERIORITY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001|TWO_SIDED|95.0|-0.81|-0.57|||Mixed Model with Repeated Measures|||Body Sites, Week 8||-0.57|-0.81|<0.0001
71074861|NCT05459558|141658834|SUPERIORITY||Mean Difference (Final Values)|-0.89|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|-0.97|-0.82|||Mixed Model with Repeated Measures|||Area, Week 4||-0.82|-0.97|<0.0001
71074862|NCT05459558|141658834|SUPERIORITY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|-0.95|-0.79|||Mixed Model with Repeated Measures|||Area, Week 4||-0.79|-0.95|<0.0001
71074863|NCT05459558|141658834|SUPERIORITY||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|-1.15|-1.01|||Mixed Model with Repeated Measures|||Area, Week 8||-1.01|-1.15|<0.0001
71074864|NCT05459558|141658834|SUPERIORITY||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|-1.22|-1.07|||Mixed Model with Repeated Measures|||Area, Week 8||-1.07|-1.22|<0.0001
71074865|NCT05459558|141658834|SUPERIORITY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|-0.93|-0.8|||Mixed Model with Repeated Measures|||Intensity, Week 4||-0.80|-0.93|<0.0001
71074866|NCT05459558|141658834|SUPERIORITY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|-0.93|-0.8|||Mixed Model with Repeated Measures|||Intensity, Week 4||-0.80|-0.93|<0.0001
71074867|NCT05459558|141658834|SUPERIORITY||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|-1.04|-0.9|||Mixed Model with Repeated Measures|||Intensity, Week 8||-0.90|-1.04|<0.0001
71074868|NCT05459558|141658834|SUPERIORITY||Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|-1.08|-0.95|||Mixed Model with Repeated Measures|||Intensity, Week 8||-0.95|-1.08|<0.0001
71074869|NCT03292458|141658840|SUPERIORITY|The primary efficacy outcome was analyzed using a restricted maximum likelihood (REML)-based linear mixed-effect model. The analysis included group, treatment, and treatment period as interacting fixed effects and subject as random effect. An unstructured covariance structure was used to model the within-patient errors.||||||0.01|TWO_SIDED|98.75|||||Mixed Models Analysis|||||||0.01
71074870|NCT03292458|141658841|OTHER|The minimum and average efficacy (in % symptom change) of sodium oxybate versus placebo in improving symptoms compared to the baseline was determined using binomial logistic regression.||||||0.05|TWO_SIDED|98.75|||||Regression, Logistic|||The minimum and average efficacy of sodium oxybate vs. placebo in improving symptoms compared to the baseline were determined using binomial logistic regression.||||0.05
71074871|NCT03292458|141658842|OTHER||Mean Difference (Final Values)|98.75||||0.01|TWO_SIDED||||||t-test, 2 sided|||||||0.01
71074872|NCT03292458|141658843|OTHER|||||||0.01|TWO_SIDED|98.75|||||ANOVA|||||||0.01
71074873|NCT03292458|141658844|OTHER|||||||0.01|TWO_SIDED|98.75|||||Pearson correlation|||||||0.01
71074874|NCT03292458|141658845|OTHER|||||||0.01|TWO_SIDED|98.75|||||Pearson correlation|||||||0.01
71074875|NCT04643964|141658939|SUPERIORITY|||||||0.54|||||||ANCOVA|||In this model, the condition included the following levels: entrée, sampler, and control. No covariates were included.||||.54
71074876|NCT04643964|141658940|SUPERIORITY|||||||0.92|||||||ANCOVA|||In this model, the condition included the following levels: entrée, sampler, and control. There was one covariate in this model: QIDS at Time 1.||||.92
71074877|NCT04643964|141658941|SUPERIORITY|||||||0.37|||||||ANCOVA|||In this model, the condition included the following levels: entrée, sampler, and control. There were three covariates in this model: QIDS at Time 1, gender, and COVID interference.||||.37
71116277|NCT05248997|141739153|SUPERIORITY||Difference in least square mean|0.04||||0.889|TWO_SIDED|95.0|-0.51|0.59||LM included baseline value as covariate, and fixed effects for treatment group,stratification factor,scheduled TP, TP by treatment group interaction.Repeated measures:modelled by unstructured covariance structure for within participant error.|Linear model (LM)|||||0.59|-0.51|0.8890
71116278|NCT05248997|141739154|SUPERIORITY||Percentage difference|3.8||||0.6412|TWO_SIDED|95.0|-12.1|19.7|||Mantel-Haenszel|Stratified by presence of nasal polyps at randomization with Mantel-Haenszel risk estimation.||||19.7|-12.1|0.6412
71116279|NCT05248997|141739155|SUPERIORITY||Percentage difference|-2.7||||0.5001|TWO_SIDED|95.0|-10.6|5.2|||Mantel-Haenszel|Stratified by presence of nasal polyps at randomization with Mantel-Haenszel risk estimation.||||5.2|-10.6|0.5001
71116280|NCT01453205|141739156|SUPERIORITY_OR_OTHER|||||||0.5543|||||||Cochran-Mantel-Haenszel|||||||0.5543
71074878|NCT04643964|141658942|SUPERIORITY|||||||0.87|||||||ANCOVA|||In this model, the condition included the following levels: entrée, sampler, and control. There was one covariate in this model: QIDS at Time 1.||||.87
71074879|NCT01472939|141658943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.06||||0.128|TWO_SIDED|95.0|-1.743|13.862|||Mixed Models Repeated Measures Analysis|||||13.862|-1.743|0.128
71074880|NCT01472939|141658943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.42||||0.062|TWO_SIDED|95.0|-0.378|15.212|||Mixed Models Repeated Measures Analysis|||||15.212|-0.378|0.062
71074881|NCT01472939|141658943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.83||||0.65|TWO_SIDED|95.0|-6.1|9.765|||Mixed Models Repeated Measures Analysis|||||9.765|-6.100|0.650
71074882|NCT01472939|141658944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.75||||0.102|TWO_SIDED|95.0|-1.344|14.85|||Mixed Models Repeated Measures Analysis|||||14.850|-1.344|0.102
71074883|NCT01472939|141658944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.92||||0.031|TWO_SIDED|95.0|0.814|17.021|||Mixed Models Repeated Measures Analysis|||||17.021|0.814|0.031
71116281|NCT01453205|141739157|SUPERIORITY_OR_OTHER|||||||0.8567|||||||Log Rank|||||||0.8567
71116282|NCT01453205|141739158|SUPERIORITY_OR_OTHER|||||||0.7412|||||||Log Rank|||||||0.7412
71116283|NCT01453205|141739159|SUPERIORITY_OR_OTHER|||||||0.9996|||||||Log Rank|||||||0.9996
71116284|NCT01453205|141739160|SUPERIORITY_OR_OTHER|||||||0.1686|||||||Log Rank|||||||0.1686
71116285|NCT02602275|141739208|SUPERIORITY|||||||0.004||||||Significance level is 0.05, corrected for multiple comparisons in the search volume which is anatomically defined by the Automated Anatomical Labelling Atlas (AAL) coordinates.|Paired t-test|||||||0.004
71116286|NCT02602275|141739209|SUPERIORITY||||||>|0.05||||||Significance level is 0.05, corrected for multiple comparisons in the search volume which is anatomically defined by the Automated Anatomical Labelling Atlas (AAL) coordinates.|Paired t-test|||||||>0.05
71116287|NCT02602275|141739210|SUPERIORITY||||||<|0.001||||||Significance level was 0.05.|Paired t-test|The outcome was deemed exploratory, as multiplicity was controlled using a priori ordered hypotheses, but the preceding endpoint was not met.||||||<0.001
70853548|NCT02720107|141195164|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||CD4+ Naïve T cells||||< 0.0001
71074884|NCT01472939|141658944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.71||||0.175|TWO_SIDED|95.0|-2.54|13.957|||Mixed Models Repeated Measures Analysis|||||13.957|-2.540|0.175
71074885|NCT01472939|141658945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.47||||0.064|TWO_SIDED|95.0|-5.087|0.141|||Mixed Models Repeated Measures Analysis|||||0.141|-5.087|0.064
71116288|NCT02602275|141739211|SUPERIORITY||||||>|0.05||||||Significance level is 0.05, corrected for multiple comparisons in the search volume which is anatomically defined by the Automated Anatomical Labelling Atlas (AAL) coordinates.|Paired t-test|||||||>0.05
71074886|NCT01472939|141658945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2||||0.017|TWO_SIDED|95.0|-5.818|-0.573|||Mixed Models Repeated Measures Analysis|||||-0.573|-5.818|0.017
71074887|NCT01472939|141658945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.15||||0.114|TWO_SIDED|95.0|-4.813|0.519|||Mixed Models Repeated Measures Analysis|||||0.519|-4.813|0.114
71074888|NCT00308750|141658955|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|||||||Log Rank|||||||0.40
71074889|NCT00308750|141658955|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19|||||||Log Rank|||||||0.19
71074890|NCT00308750|141658959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96||||||P-value is for the change in Total FACT-L at Cycle 1 (Week 3).|ANCOVA|||||||0.96
71074891|NCT00308750|141658959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15||||||P-value is for the change in Total FACT-L at Cycle 1 (Week 3).|ANCOVA|||||||0.15
71074892|NCT00308750|141658959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92||||||P-value is for the change in Total FACT-L at Cycle 2 (Week 6).|ANCOVA|||||||0.92
71074893|NCT00308750|141658959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97||||||P-value is for the change in Total FACT-L at Cycle 2 (Week 6).|ANCOVA|||||||0.97
71074894|NCT00308750|141658959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71||||||P-value is for the change in Total FACT-L at Cycle 3 (Week 9).|ANCOVA|||||||0.71
71074895|NCT00308750|141658959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66||||||P-value is for the change in Total FACT-L at Cycle 3 (Week 9).|ANCOVA|||||||0.66
71074896|NCT00308750|141658959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93||||||P-value is for the change in Total FACT-L at Cycle 4 (Week 12).|ANCOVA|||||||0.93
71074897|NCT00308750|141658959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33||||||P-value is for the change in Total FACT-L at Cycle 4 (Week 12).|ANCOVA|||||||0.33
71074898|NCT00308750|141658959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19||||||P-value is for the change in Total FACT-L at Cycle 5 (Week 15).|ANCOVA|||||||0.19
71074899|NCT00308750|141658959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4||||||P-value is for the change in Total FACT-L at Cycle 5 (Week 15).|ANCOVA|||||||0.40
71074900|NCT00308750|141658959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63||||||P-value is for the change in Total FACT-L at Cycle 6 (Week 18).|ANCOVA|||||||0.63
71074901|NCT00308750|141658959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||||||P-value is for the change in Total FACT-L at Cycle 6 (Week 18).|ANCOVA|||||||0.55
71074902|NCT00308750|141658960|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93||||||P-value is for the change in Total FACT-Taxane at Cycle 1 (Week 3).|ANCOVA|||||||0.93
71074903|NCT00308750|141658960|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86||||||P-value is for the change in Total FACT-Taxane at Cycle 1 (Week 3).|ANCOVA|||||||0.86
71074904|NCT00308750|141658960|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69||||||P-value is for the change in Total FACT-Taxane at Cycle 2 (Week 6).|ANCOVA|||||||0.69
71074905|NCT00308750|141658960|SUPERIORITY_OR_OTHER_LEGACY|||||||0.77||||||P-value is for the change in Total FACT-Taxane at Cycle 2 (Week 6).|ANCOVA|||||||0.77
71074906|NCT00308750|141658960|SUPERIORITY_OR_OTHER_LEGACY|||||||0.83||||||P-value is for the change in Total FACT-Taxane at Cycle 3 (Week 9).|ANCOVA|||||||0.83
71074907|NCT00308750|141658960|SUPERIORITY_OR_OTHER_LEGACY|||||||0.78||||||P-value is for the change in Total FACT-Taxane at Cycle 3 (Week 9).|ANCOVA|||||||0.78
71074908|NCT00308750|141658960|SUPERIORITY_OR_OTHER_LEGACY|||||||1||||||P-value is for the change in Total FACT-Taxane at Cycle 4 (Week 12).|ANCOVA|||||||1.00
71074909|NCT00308750|141658960|SUPERIORITY_OR_OTHER_LEGACY|||||||0.91||||||P-value is for the change in Total FACT-Taxane at Cycle 4 (Week 12).|ANCOVA|||||||0.91
71074910|NCT00308750|141658960|SUPERIORITY_OR_OTHER_LEGACY|||||||0.49||||||P-value is for the change in Total FACT-Taxane at Cycle 5 (Week 15).|ANCOVA|||||||0.49
71074911|NCT00308750|141658960|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53||||||P-value is for the change in Total FACT-Taxane at Cycle 5 (Week 15).|ANCOVA|||||||0.53
71074912|NCT00308750|141658960|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8||||||P-value is for the change in Total FACT-Taxane at Cycle 6 (Week 18).|ANCOVA|||||||0.80
71074913|NCT00308750|141658960|SUPERIORITY_OR_OTHER_LEGACY|||||||0.85||||||P-value is for the change in Total FACT-Taxane at Cycle 6 (Week 18).|ANCOVA|||||||0.85
71074914|NCT00308750|141658961|SUPERIORITY_OR_OTHER_LEGACY|||||||0.87|||||||Log Rank|||||||0.87
71074915|NCT00308750|141658961|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Log Rank|||||||0.05
71074916|NCT00308750|141658964|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71|||||||Log Rank|||||||0.71
71074917|NCT00308750|141658964|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|||||||Log Rank|||||||0.04
71074918|NCT00388297|141658975|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate|0.0||||0.71|TWO_SIDED|95.0|-3.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|-3|0.71
71074919|NCT00388297|141658975|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate|-1.0||||0.3|TWO_SIDED|95.0|-4.0|1.0|||Wilcoxon (Mann-Whitney)|||||1|-4|0.30
71074920|NCT00388297|141658976|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
71074921|NCT00388297|141658976|SUPERIORITY_OR_OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
71074922|NCT00388297|141658977|SUPERIORITY_OR_OTHER|||||||0.81|||||||Chi-squared|||Analysis for \< 34 weeks||||0.81
71074923|NCT00388297|141658977|SUPERIORITY_OR_OTHER|||||||0.47|||||||Chi-squared|||Analysis for \<34 weeks||||0.47
71074924|NCT00388297|141658977|SUPERIORITY_OR_OTHER|||||||0.44|||||||Chi-squared|||Analysis for \<37 weeks||||0.44
71074925|NCT00388297|141658977|SUPERIORITY_OR_OTHER|||||||0.11|||||||Chi-squared|||Analysis for \< 37 weeks||||0.11
71074926|NCT00388297|141658977|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.31|TWO_SIDED|95.0|0.0|3.0|||Chi-squared|||Bayley-III Motor (24 months)||3|0|0.31
71074927|NCT00388297|141658977|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.3|TWO_SIDED|95.0|0.0|3.0|||Chi-squared|||Bayley-II Language (24 months)||3|0|0.30
71074928|NCT00388297|141658977|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.89|TWO_SIDED|95.0|0.0|0.0|||Chi-squared|||Bayley-III Cognitive (12 months)||0|0|0.89
71074929|NCT00388297|141658977|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.54|TWO_SIDED|95.0|0.0|3.0|||Chi-squared|||Bayley-III Motor (12 months)||3|0|0.54
71074930|NCT00388297|141658977|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.92|TWO_SIDED|95.0|-3.0|3.0|||Chi-squared|||Bayley-III Language (12 months)||3|-3|0.92
71074931|NCT00388297|141658977|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.7|TWO_SIDED|95.0|0.0|0.0|||Chi-squared|||Bayley-III Cognitive (24 months)||0|0|0.70
71074932|NCT00388297|141658977|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.2|TWO_SIDED|95.0|-3.0|0.0|||Chi-squared|||Bayley-III Motor (24 months)||0|-3|0.20
71074933|NCT00388297|141658977|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.71|TWO_SIDED|95.0|-3.0|2.0|||Chi-squared|||Bayley-II Language (24 months)||2|-3|0.71
71074934|NCT00388297|141658978|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.89|TWO_SIDED|95.0|-3.0|2.0|||Chi-squared|||||2|-3|0.89
71074935|NCT00388297|141658978|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-1.0||||0.48|TWO_SIDED|95.0|-3.0|2.0|||Chi-squared|||||2|-3|0.48
71074936|NCT00388297|141658979|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.9|TWO_SIDED|95.0|-2.0|3.0|||Chi-squared|||||3|-2|0.90
71074937|NCT00388297|141658979|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-1.0||||0.64|TWO_SIDED|95.0|-3.0|2.0|||Chi-squared|||||2|-3|0.64
71074938|NCT00388297|141658980|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.6|TWO_SIDED|95.0|-5.0|7.0|||Chi-squared|||Analysis for recall of digits forward||7|-5|0.60
71074939|NCT00388297|141658980|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.22|TWO_SIDED|95.0|-8.0|0.0|||Chi-squared|||Analysis for recall of digits forward||0|-8|0.22
71074940|NCT00388297|141658980|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.52|TWO_SIDED|95.0|-6.0|0.0|||Chi-squared|||Analysis for Recognition of Pictures||0|-6|0.52
71074941|NCT00388297|141658980|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.91|TWO_SIDED|95.0|-4.0|0.0|||Chi-squared|||Analysis for Recognition of Pictures||0|-4|0.91
71074942|NCT00388297|141658981|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.63|TWO_SIDED|95.0|0.0|0.0|||Chi-squared|||Bayley II Cognitive (12 months)||0|0|0.63
71074943|NCT00388297|141658981|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.83|TWO_SIDED|95.0|0.0|3.0|||Chi-squared|||Bayley II Motor (12 mo)||3|0|0.83
71074944|NCT00388297|141658981|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.48|TWO_SIDED|95.0|0.0|3.0|||Chi-squared|||Bayley-III Language (12 months)||3|0|0.48
71074945|NCT00388297|141658981|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.59|TWO_SIDED|95.0|0.0|0.0|||Chi-squared|||Bayley-III Cognitive (24 months)||0|0|0.59
71074946|NCT00388297|141658982|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.99|TWO_SIDED|95.0|-2.0|2.0|||Chi-squared|||CBCL at 36 months||2|-2|0.99
71074947|NCT00388297|141658982|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.96|TWO_SIDED|95.0|-2.0|2.0|||Chi-squared|||CBCL at 60 months||2|-2|0.96
71074948|NCT00388297|141658982|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.65|TWO_SIDED|95.0|-2.0|2.0|||Chi-squared|||CBCL at 36 months||2|-2|0.65
70940733|NCT05129592|141381616|SUPERIORITY||Odds Ratio (OR)|0.74|STANDARD_ERROR_OF_MEAN|0.7||0.754|TWO_SIDED|95.0|0.12|4.76|||Regression, Logistic||Odds of believing NRT is less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing NRT is less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on NRT relative harm beliefs controlling for NRT use||4.76|0.12|0.754
70940734|NCT05129592|141381617|SUPERIORITY||Odds Ratio, log|1.69|STANDARD_ERROR_OF_MEAN|0.78||0.256|TWO_SIDED|95.0|0.68|4.15|||Regression, Logistic||Odds of believing VLNC are less harmful than cigarettes in the control condition/odds of believing VLNC are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on VLNC relative harm beliefs||4.15|0.68|0.256
70940735|NCT05129592|141381617|SUPERIORITY||Odds Ratio (OR)|1.02|STANDARD_ERROR_OF_MEAN|0.43||0.961|TWO_SIDED|95.0|0.45|2.32|||Regression, Logistic||Odds of believing VLNC are less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing VLNC are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on VLNC relative harm beliefs||2.32|0.45|0.961
70940736|NCT05129592|141381617|SUPERIORITY||Odds Ratio (OR)|0.67|STANDARD_ERROR_OF_MEAN|0.28||0.345|TWO_SIDED|95.0|0.3|1.53|||Regression, Logistic||Odds of believing VLNC are less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing VLNC are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on VLNC relative harm beliefs||1.53|0.30|0.345
71074949|NCT00388297|141658982|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-1.0||||0.44|TWO_SIDED|95.0|-3.0|1.0|||Chi-squared|||CBCL at 60 months||1|-3|0.44
71074950|NCT00388297|141658983|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.37|TWO_SIDED|95.0|-1.0|2.0|||Chi-squared|||||2|-1|0.37
71074951|NCT00388297|141658983|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.98|TWO_SIDED|95.0|-2.0|2.0|||Chi-squared|||||2|-2|0.98
71074952|NCT00388297|141658984|SUPERIORITY_OR_OTHER|||||||0.12|||||||Chi-squared|||||||0.12
71074953|NCT00388297|141658984|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.00
71074954|NCT00388297|141658985|SUPERIORITY_OR_OTHER|||||||0.69|||||||Chi-squared|||||||0.69
71074955|NCT00388297|141658985|SUPERIORITY_OR_OTHER|||||||0.51|||||||Chi-squared|||||||0.51
71074956|NCT00388297|141658986|SUPERIORITY_OR_OTHER|||||||0.76|||||||Chi-squared|||||||0.76
71074957|NCT00388297|141658986|SUPERIORITY_OR_OTHER|||||||0.64|||||||Chi-squared|||||||0.64
71074958|NCT00388297|141658987|SUPERIORITY_OR_OTHER|||||||0.66|||||||Chi-squared|||||||0.66
71074959|NCT00388297|141658987|SUPERIORITY_OR_OTHER|||||||0.62|||||||Chi-squared|||||||0.62
71074960|NCT00388297|141658988|SUPERIORITY_OR_OTHER|||||||0.24|||||||Chi-squared|||||||0.24
71074961|NCT00388297|141658988|SUPERIORITY_OR_OTHER|||||||0.55|||||||Chi-squared|||||||0.55
71074962|NCT00388297|141658989|SUPERIORITY_OR_OTHER|||||||0.36|||||||Chi-squared|||||||0.36
71074963|NCT00388297|141658989|SUPERIORITY_OR_OTHER|||||||0.28|||||||Chi-squared|||||||0.28
71074964|NCT00388297|141658990|SUPERIORITY_OR_OTHER|||||||0.5|||||||Chi-squared|||||||0.50
71074965|NCT00388297|141658990|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.00
71074966|NCT00388297|141658991|SUPERIORITY_OR_OTHER|||||||0.76|||||||Chi-squared|||Apgar at 1 min \< 4||||0.76
71074967|NCT00388297|141658991|SUPERIORITY_OR_OTHER|||||||0.76|||||||Chi-squared|||Apgar \> 4 at 1 minute||||0.76
71074968|NCT00388297|141658991|SUPERIORITY_OR_OTHER|||||||0.69|||||||Chi-squared|||Apgar \< 7 at 5 minutes||||0.69
71074969|NCT00388297|141658991|SUPERIORITY_OR_OTHER|||||||0.45|||||||Chi-squared|||Apgar \< 7 at 5 minutes||||0.45
71074970|NCT00388297|141658992|SUPERIORITY_OR_OTHER|||||||0.24|||||||Chi-squared|||||||0.24
71074971|NCT00388297|141658992|SUPERIORITY_OR_OTHER|||||||0.97|||||||Chi-squared|||||||0.97
71074972|NCT00388297|141658993|SUPERIORITY_OR_OTHER|||||||0.45|||||||Chi-squared|||||||0.45
71074973|NCT00388297|141658993|SUPERIORITY_OR_OTHER|||||||0.68|||||||Chi-squared|||||||0.68
71074974|NCT00388297|141658994|SUPERIORITY_OR_OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
71074975|NCT00388297|141658994|SUPERIORITY_OR_OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
71074976|NCT00388297|141658995|SUPERIORITY_OR_OTHER|||||||0.45|||||||Chi-squared|||||||0.45
71074977|NCT00388297|141658995|SUPERIORITY_OR_OTHER|||||||0.75|||||||Chi-squared|||||||0.75
71074978|NCT00388297|141658996|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
71074979|NCT00388297|141658997|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
71074980|NCT00388297|141658997|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||||||0.50
71074981|NCT00388297|141658998|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||||||0.50
71074982|NCT00388297|141658998|SUPERIORITY_OR_OTHER|||||||0.49|||||||Fisher Exact|||||||0.49
71074983|NCT00388297|141658999|SUPERIORITY_OR_OTHER|||||||0.99|||||||Chi-squared|||||||0.99
71074984|NCT00388297|141658999|SUPERIORITY_OR_OTHER|||||||0.85|||||||Chi-squared|||||||0.85
71074985|NCT00388297|141659000|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
71074986|NCT00388297|141659000|SUPERIORITY_OR_OTHER|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
71074987|NCT01492101|141659007|OTHER|Two-sided log-rank test, stratified by geographic region, prior use of eribulin, and receptor status.|Hazard Ratio, log|0.872|||=|0.0835|TWO_SIDED|95.0|0.747|1.019|||Log Rank|||||1.019|0.747|= 0.0835
71074988|NCT01492101|141659008|SUPERIORITY||Hazard Ratio (HR)|0.926|||=|0.3017|TWO_SIDED|95.0|0.798|1.075|||Log Rank|||||1.075|0.798|= 0.3017
71116289|NCT02602275|141739212|SUPERIORITY||||||<|0.05||||||Significance level is 0.05, corrected for multiple comparisons in the search volume which is anatomically defined by the AAL (Automated Anatomical Labelling Atlas) coordinates.|Paired t-test|The outcome was deemed exploratory, as multiplicity was controlled using a priori ordered hypotheses, but a preceding endpoint was not met.||||||<0.05
70940737|NCT05129592|141381617|SUPERIORITY||Odds Ratio (OR)|1.56|STANDARD_ERROR_OF_MEAN|0.76||0.36|TWO_SIDED|95.0|0.6|4.04|||Regression, Logistic||Odds of believing VLNC are less harmful than cigarettes in the control condition/odds of believing VLNC are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on VLNC relative harm beliefs controlling for baseline beliefs and VLNC use||4.04|0.60|0.360
70940738|NCT05129592|141381617|SUPERIORITY||Odds Ratio (OR)|1.14|STANDARD_ERROR_OF_MEAN|0.5||0.765|TWO_SIDED|95.0|0.48|2.7|||Regression, Logistic||Odds of believing VLNC are less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing VLNC are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on VLNC relative harm beliefs controlling for baseline beliefs and VLNC use||2.70|0.48|0.765
71074989|NCT01492101|141659013|EQUIVALENCE|\[2\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.8||||0.635|TWO_SIDED|95.0|-2.65|4.33|||F-test|||Global health status/QoL: change from baseline to last assessment (Week 56)||4.33|-2.65|0.635
71074990|NCT01492101|141659013|EQUIVALENCE|\[3\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|2.1||||0.1656|TWO_SIDED|95.0|-0.88|5.14|||F-test|||||5.14|-0.88|0.1656
71074991|NCT01492101|141659013|EQUIVALENCE|\[4\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Median Difference (Final Values)|0.5||||0.8356|TWO_SIDED|95.0|-3.9|4.82|||F-test|||||4.82|-3.9|0.8356
71074992|NCT01492101|141659013|EQUIVALENCE|\[5\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.5||||0.7727|TWO_SIDED|95.0|-2.88|3.88|||F-test|||||3.88|-2.88|0.7727
71074993|NCT01492101|141659013|EQUIVALENCE|\[6\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.5||||0.7446|TWO_SIDED|95.0|-2.56|3.59|||F-test|||||3.59|-2.56|0.7446
71074994|NCT01492101|141659013|EQUIVALENCE|\[7\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.2||||0.9169|TWO_SIDED|95.0|-4.0|4.45|||F-test|||||4.45|-4.0|0.9169
71074995|NCT01492101|141659013|EQUIVALENCE|\[8\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.1||||0.9731|TWO_SIDED|95.0|-3.66|3.79|||F-test|||||3.79|-3.66|0.9731
71074996|NCT01492101|141659013|EQUIVALENCE|\[9\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|7.3|||<|0.0001|TWO_SIDED|95.0|3.88|10.67|||F-test|||||10.67|3.88|<0.0001
71074997|NCT01492101|141659013|EQUIVALENCE|\[10\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-2.8||||0.1252|TWO_SIDED|95.0|-7.59|0.93|||F-test|||||0.93|-7.59|0.1252
71074998|NCT01492101|141659013|EQUIVALENCE|\[11\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-2.8||||0.1717|TWO_SIDED|95.0|-6.83|1.22|||F-test|||||1.22|-6.83|0.1717
71074999|NCT01492101|141659013|EQUIVALENCE|\[12\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-1.4||||0.5513|TWO_SIDED|95.0|-5.95|3.18|||F-test|||||3.18|-5.95|0.5513
71116290|NCT04262882|141739213|SUPERIORITY||Odds Ratio (OR)|1.67||||0.2|TWO_SIDED|95.0|0.77|3.64|||Regression, Logistic|Adjusted for age and religion. Analysis in GEE to account for dependence in repeated, dyadic data.|Reference group is the comparator arm|||3.64|0.77|0.20
71116291|NCT04262882|141739216|SUPERIORITY||Wald Chi-Square|35.2|||<|0.001|TWO_SIDED||||||Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.|Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints.|||||<0.001
71075000|NCT01492101|141659013|EQUIVALENCE|\[13\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|8.6||||0.0009|TWO_SIDED|95.0|3.57|13.72|||F-test|||||13.72|3.57|0.0009
71075001|NCT01492101|141659013|EQUIVALENCE|\[14\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-2.8||||0.2337|TWO_SIDED|95.0|-7.35|1.8|||F-test|||||1.8|-7.35|0.2337
71075002|NCT01492101|141659013|EQUIVALENCE|\[15\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|10.3|||<|0.0001|TWO_SIDED|95.0|6.6|13.98|||F-test|||||13.98|6.6|<0.0001
71075003|NCT01492101|141659013|EQUIVALENCE|\[16\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED|95.0|-3.74|3.69|||F-test|||||3.69|-3.74|0.99
71075004|NCT01492101|141659015|EQUIVALENCE|\[17\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.9||||0.5833|TWO_SIDED|95.0|-2.42|4.29|||F-test|||||4.29|-2.42|0.5833
71075005|NCT01492101|141659015|EQUIVALENCE|\[18\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|1.3||||0.3098|TWO_SIDED|95.0|-1.24|3.9|||F-test|||||3.9|-1.24|0.3098
71075006|NCT01492101|141659015|EQUIVALENCE|\[19\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|1.1||||0.6264|TWO_SIDED|95.0|-3.39|5.63|||F-test|||||5.63|-3.39|0.6264
71075007|NCT01492101|141659015|EQUIVALENCE|\[20\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-4.6||||0.0003|TWO_SIDED|95.0|-7.11|-2.1|||F-test|||||-2.1|-7.11|0.0003
71075008|NCT01492101|141659015|EQUIVALENCE|\[21\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-1.4||||0.2473|TWO_SIDED|95.0|-3.84|0.99|||F-test|||||0.99|-3.84|0.2473
71075009|NCT01492101|141659015|EQUIVALENCE|\[22\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-2.9||||0.0333|TWO_SIDED|95.0|-5.54|-0.23|||F-test|||||-0.23|-5.54|0.0333
71075010|NCT01492101|141659015|EQUIVALENCE|\[23\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-4.5||||0.2575|TWO_SIDED|95.0|-12.2|3.28|||F-test|||||3.28|-12.2|0.2575
71075011|NCT01492101|141659015|EQUIVALENCE|\[24\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|5.6||||0.1072|TWO_SIDED|95.0|-1.22|12.34|||F-test|||||12.34|-1.22|0.1072
71075012|NCT00460265|141659044|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.873||||0.1403||95.0|0.729|1.046|||Log Rank|Stratified by IVRS randomization factors (ECOG(0:1),previously treated w/ CT/RT(yes:no),primary tumor site(oropharynx/larynx:oral cavity/hypopharynx))|Hazard ratio from Cox proportional hazards model stratified by IVRS randomization factors; hazard ratio presented as panitumumab plus chemotherapy:chemotherapy alone.|||1.046|0.729|0.1403
71075013|NCT00460265|141659045|SUPERIORITY_OR_OTHER||Difference in percentages|10.98||||||95.0|3.13|18.68||||||||18.68|3.13|
71075014|NCT00460265|141659045|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.69||||||95.0|1.15|2.44||||||||2.44|1.15|
71075015|NCT00460265|141659049|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||||95.0|0.659|0.922|||||Cox proportional hazards model stratified by IVRS randomization factors|||0.922|0.659|
71075016|NCT04526574|141659101|NON_INFERIORITY|Noninferiority (NI) for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|Geometric Mean Ratio (GMR)|0.74|||||TWO_SIDED|95.0|0.65|0.84||||||Serotype 1: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of least square (LS) means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.84|0.65|
71075017|NCT04526574|141659101|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.82|||||TWO_SIDED|95.0|0.75|0.9||||||Serotype 3: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.90|0.75|
71075018|NCT04526574|141659101|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.89|||||TWO_SIDED|95.0|0.77|1.02||||||Serotype 4: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||1.02|0.77|
71075019|NCT04526574|141659101|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.88|||||TWO_SIDED|95.0|0.79|0.98||||||Serotype 5: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.98|0.79|
71078815|NCT01796301|141665659|SUPERIORITY||Treatment difference|3.8|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.9|4.6|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.||4.6|2.9|< 0.0001
71116292|NCT04262882|141739216|SUPERIORITY||unstandardized beta|0.41|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
71116293|NCT04262882|141739216|SUPERIORITY||unstandardized beta|0.4|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
71116294|NCT04262882|141739217|SUPERIORITY||Wald Chi-Square|64.53|||<|0.001|TWO_SIDED|||||Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints.||"Tests of significance for each follow-up time point:~7-months: unstandardized beta=1.08, standard error=0.14, p \< 0.001; 10-months: unstandardized beta=0.79, standard error=0.14, p \< 0.001"|||<0.001
71116295|NCT04262882|141739217|SUPERIORITY||Mean Difference (Final Values)|1.08|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||Adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
71116296|NCT04262882|141739217|SUPERIORITY||unstandardized beta|0.79|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||Adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
71116297|NCT04262882|141739218|SUPERIORITY||Wald Chi-Square|23.89|||<|0.001|TWO_SIDED||||||Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
71079417|NCT00482170|141666434|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.43|||<|0.001|TWO_SIDED|95.0|1.61|3.67||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4:A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.67|1.61|<0.001
71079418|NCT00482170|141666434|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.74|||<|0.001|TWO_SIDED|95.0|1.78|4.21||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||4.21|1.78|<0.001
71079419|NCT00482170|141666434|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.51|||<|0.001|TWO_SIDED|95.0|1.66|3.8||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||3.80|1.66|<0.001
71079420|NCT00482170|141666435|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88||||0.004|TWO_SIDED|95.0|1.22|2.89||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.89|1.22|0.004
71079421|NCT00482170|141666435|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.017|TWO_SIDED|95.0|1.1|2.72||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.72|1.10|0.017
71079422|NCT00482170|141666435|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.34|||<|0.001|TWO_SIDED|95.0|1.47|3.73||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.73|1.47|<0.001
71079423|NCT00482170|141666435|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06||||0.001|TWO_SIDED|95.0|1.32|3.21||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||3.21|1.32|0.001
71079424|NCT00482170|141666436|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.025|TWO_SIDED|95.0|1.07|2.64||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.64|1.07|0.025
71079425|NCT00482170|141666436|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.936|TWO_SIDED|95.0|0.63|1.64||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.64|0.63|0.936
71079426|NCT00482170|141666436|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.42|TWO_SIDED|95.0|0.75|1.99||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.99|0.75|0.420
70940739|NCT05129592|141381617|SUPERIORITY||Odds Ratio (OR)|0.6|STANDARD_ERROR_OF_MEAN|0.27||0.252|TWO_SIDED|95.0|0.25|1.43|||Regression, Logistic||Odds of believing VLNC are less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing VLNC are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on VLNC relative harm beliefs controlling for baseline beliefs and VLNC use||1.43|0.25|0.252
70940740|NCT05129592|141381618|SUPERIORITY||Odds Ratio (OR)|0.45|STANDARD_ERROR_OF_MEAN|0.2||0.077|TWO_SIDED|95.0|0.18|1.09|||Regression, Logistic||Odds of believing smokeless tobacco is less harmful than cigarettes in the control condition/odds of believing smokeless tobacco is less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on smokeless tobacco relative harm beliefs||1.09|0.18|0.077
70940741|NCT05129592|141381618|SUPERIORITY||Odds Ratio (OR)|0.92|STANDARD_ERROR_OF_MEAN|0.4||0.853|TWO_SIDED|95.0|0.4|2.15|||Regression, Logistic|||Unadjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on smokeless tobacco relative harm beliefs|Odds of believing smokeless tobacco is less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing smokeless tobacco is less harmful than cigarettes in the condition with both component of coherence|2.15|0.40|0.853
70940742|NCT05129592|141381618|SUPERIORITY||Odds Ratio, log|0.41|STANDARD_ERROR_OF_MEAN|0.18||0.037|TWO_SIDED|95.0|0.18|0.95|||Regression, Logistic||Odds of believing smokeless tobacco is less harmful than cigarettes in the Nicotine corrective with both components of coherence/odds of believing smokeless tobacco is less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on smokeless tobacco relative harm beliefs||0.95|0.18|0.037
70940743|NCT05129592|141381618|SUPERIORITY||Odds Ratio (OR)|0.6|STANDARD_ERROR_OF_MEAN|0.33||0.349|TWO_SIDED|95.0|0.21|1.75|||Regression, Logistic||Odds of believing smokeless tobacco is less harmful than cigarettes in the control condition/odds of believing smokeless tobacco is less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on smokeless relative harm beliefs controlling for baseline beliefs and smokeless tobacco use||1.75|0.21|0.349
70940744|NCT05129592|141381618|SUPERIORITY||Odds Ratio (OR)|1.45|STANDARD_ERROR_OF_MEAN|0.74||0.464|TWO_SIDED|95.0|0.54|3.93|||Regression, Logistic||Odds of believing smokeless tobacco is less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing smokeless tobacco is less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on smokeless relative harm beliefs controlling for baseline beliefs and smokeless tobacco use||3.93|0.54|0.464
71075020|NCT04526574|141659101|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.76|||||TWO_SIDED|95.0|0.65|0.88||||||Serotype 6A: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.88|0.65|
70940745|NCT05129592|141381618|SUPERIORITY||Odds Ratio (OR)|0.5|STANDARD_ERROR_OF_MEAN|0.26||0.187|TWO_SIDED|95.0|0.18|1.4|||Regression, Logistic||Odds of believing smokeless tobacco is less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing smokeless tobacco is less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on smokeless relative harm beliefs controlling for baseline beliefs and smokeless tobacco use||1.40|0.18|0.187
71075021|NCT04526574|141659101|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.81|||||TWO_SIDED|95.0|0.71|0.94||||||Serotype 6B: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.94|0.71|
71079427|NCT00482170|141666436|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.625|TWO_SIDED|95.0|0.71|1.79||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.79|0.71|0.625
71079428|NCT00482170|141666437|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.21|TWO_SIDED|95.0|0.86|1.94||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.94|0.86|0.210
71079429|NCT00482170|141666437|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.227|TWO_SIDED|95.0|0.85|2.03||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.03|0.85|0.227
70940746|NCT05129592|141381619|SUPERIORITY||Odds Ratio (OR)|1.06|STANDARD_ERROR_OF_MEAN|0.66||0.925|TWO_SIDED|95.0|0.31|3.62|||Regression, Logistic||Odds of believing cigarillos are less harmful than cigarettes in the control condition/odds of believing cigarillos are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on cigarillo relative harm beliefs||3.62|0.31|0.925
70940747|NCT05129592|141381619|SUPERIORITY||Odds Ratio (OR)|0.66|STANDARD_ERROR_OF_MEAN|0.43||0.525|TWO_SIDED|95.0|0.19|2.35|||Regression, Logistic||Odds of believing cigarillos are less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing cigarillos are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on cigarillo relative harm beliefs||2.35|0.19|0.525
71116298|NCT04262882|141739218|SUPERIORITY||unstandardized beta|0.31|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||P value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
71116299|NCT04262882|141739218|SUPERIORITY||unstandardized beta|0.19|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
71116300|NCT04262882|141739219|SUPERIORITY||Wald Chi-Square|48.26|||<|0.001|TWO_SIDED||||||Regression, Linear|Models control for age and religion. Models were run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
71116301|NCT04262882|141739219|SUPERIORITY||unstandardized beta|0.68|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Cox|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
70940748|NCT05129592|141381619|SUPERIORITY||Odds Ratio (OR)|0.71|STANDARD_ERROR_OF_MEAN|0.44||0.586|TWO_SIDED|95.0|0.21|2.4|||Regression, Logistic||Odds of believing cigarillos are less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing cigarillos are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on cigarillo relative harm beliefs||2.40|0.21|0.586
70940749|NCT05129592|141381619|SUPERIORITY||Odds Ratio (OR)|1.1|STANDARD_ERROR_OF_MEAN|0.71||0.883|TWO_SIDED|95.0|0.31|3.9|||Regression, Logistic||Odds of believing cigarillos are less harmful than cigarettes in the control condition/odds of believing cigarillos are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on cigarillo relative harm beliefs controlling for smokeless tobacco use||3.90|0.31|0.883
70940750|NCT05129592|141381619|SUPERIORITY||Odds Ratio (OR)|0.66|STANDARD_ERROR_OF_MEAN|0.44||0.534|TWO_SIDED|95.0|0.18|2.41|||Regression, Logistic||Odds of believing cigarillos are less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing cigarillos are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on cigarillo relative harm beliefs controlling for smokeless tobacco use||2.41|0.18|0.534
70940751|NCT05129592|141381619|SUPERIORITY||Odds Ratio (OR)|0.76|STANDARD_ERROR_OF_MEAN|0.48||0.661|TWO_SIDED|95.0|0.22|2.62|||Regression, Logistic||Odds of believing cigarillos are less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing cigarillos are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on cigarillo relative harm beliefs controlling for smokeless tobacco use||2.62|0.22|0.661
71116302|NCT04262882|141739219|SUPERIORITY||unstandardized beta|0.2|STANDARD_ERROR_OF_MEAN|0.1||0.04|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.04
71116303|NCT04262882|141739220|SUPERIORITY||Wald Chi-Square|9.87||||0.007|TWO_SIDED|||||Arm\*Time p value for 10-months follow up overall.|Regression, Linear|Model controls for age and religion. Model was run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.007
71116304|NCT04262882|141739220|SUPERIORITY|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.|unstandardized beta|-0.16|STANDARD_ERROR_OF_MEAN|0.32||0.6|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|||||||0.60
71116305|NCT04262882|141739220|SUPERIORITY||Slope|-0.53|STANDARD_ERROR_OF_MEAN|0.07||0.07|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.07
71116306|NCT04262882|141739221|SUPERIORITY||Wald Chi-Square|10.42||||0.005|TWO_SIDED||||||Regression, Logistic|Model controls for age and religion. Model was run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.005
71116307|NCT04262882|141739221|SUPERIORITY||Odds Ratio (OR)|1.36||||0.05|TWO_SIDED|95.0|0.99|1.85||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Logistic|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||1.85|0.99|0.05
70853549|NCT02720107|141195164|SUPERIORITY_OR_OTHER|||||||0.0493||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from study Core study, sex and duration of disease until start of Core study|ANCOVA|||CD4+ Central memory T cells||||0.0493
71075022|NCT04526574|141659101|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.9|||||TWO_SIDED|95.0|0.83|0.99||||||Serotype 7F: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.99|0.83|
71075023|NCT04526574|141659101|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.8|||||TWO_SIDED|95.0|0.7|0.93||||||Serotype 8: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.93|0.70|
71075024|NCT04526574|141659101|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.94|||||TWO_SIDED|95.0|0.82|1.07||||||Serotype 9V: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||1.07|0.82|
71075025|NCT04526574|141659101|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.83|||||TWO_SIDED|95.0|0.71|0.96||||||Serotype 10A: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.96|0.71|
71075026|NCT04526574|141659101|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.71|||||TWO_SIDED|95.0|0.6|0.84||||||Serotype 11A: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.84|0.60|
71075027|NCT04526574|141659101|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.82|||||TWO_SIDED|95.0|0.69|0.97||||||Serotype 12F: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.97|0.69|
71075028|NCT04526574|141659101|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.86|||||TWO_SIDED|95.0|0.76|0.96||||||Serotype 14: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.96|0.76|
71075029|NCT04526574|141659101|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.7|||||TWO_SIDED|95.0|0.57|0.86||||||Serotype 15B: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.86|0.57|
71075030|NCT04526574|141659101|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.9|||||TWO_SIDED|95.0|0.77|1.04||||||Serotype 18C: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||1.04|0.77|
71116308|NCT04262882|141739221|SUPERIORITY||Odds Ratio (OR)|0.96||||0.71|TWO_SIDED|95.0|0.75|1.22||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Logistic|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||1.22|0.75|0.71
71116309|NCT04262882|141739222|SUPERIORITY||Wald Chi-Square|13.4||||0.001|TWO_SIDED||||||Regression, Linear|Model controls for age and religion. Model was run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.001
71116310|NCT04262882|141739222|SUPERIORITY||unstandardized beta|0.13|STANDARD_ERROR_OF_MEAN|0.07||0.07|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.07
71116311|NCT04262882|141739222|SUPERIORITY||unstandardized beta|0.21|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
71116312|NCT04262882|141739223|SUPERIORITY||Wald Chi-Square|78.81||||0.001|TWO_SIDED||||||Regression, Linear|Model controls for age and religion. Model was run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.001
71116313|NCT04262882|141739223|SUPERIORITY||unstandardized beta|1.19|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
71116314|NCT04262882|141739223|SUPERIORITY||unstandardized beta|1.65|STANDARD_ERROR_OF_MEAN|0.19||0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.001
71116315|NCT04262882|141739224|SUPERIORITY||Wald Chi-Square|19.46|||<|0.001|TWO_SIDED||||||Regression, Linear|Model controls for age and religion. Model was run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
71116316|NCT04262882|141739224|SUPERIORITY||unstandardized beta|-0.13|STANDARD_ERROR_OF_MEAN|0.05||0.008|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.008
71116317|NCT04262882|141739224|SUPERIORITY||unstandardized beta|-0.17|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
71116318|NCT02333396|141739234|SUPERIORITY||Beta Estimate|3.57|STANDARD_ERROR_OF_MEAN|4.53||0.44|TWO_SIDED|95.0|-5.77|12.9|||Mixed Models Analysis|||||12.9|-5.77|0.44
71116319|NCT02333396|141739235|SUPERIORITY||Beta Estimate|3.62|STANDARD_ERROR_OF_MEAN|2.05||0.09|TWO_SIDED|95.0|-0.61|7.84|||Mixed Models Analysis|||||7.84|-0.61|0.09
71116320|NCT02333396|141739236|SUPERIORITY||Beta Estimate|4.13|STANDARD_ERROR_OF_MEAN|2.05||0.05|TWO_SIDED|95.0|-0.09|8.36|||Mixed Models Analysis|||||8.36|-0.09|0.05
71116321|NCT02333396|141739237|SUPERIORITY||Beta Estimare|3.02|STANDARD_ERROR_OF_MEAN|2.26||0.19|TWO_SIDED|95.0|-1.63|7.67|||Mixed Models Analysis|||||7.67|-1.63|0.19
71116322|NCT02333396|141739238|SUPERIORITY||Beta Estimate|-0.22|STANDARD_ERROR_OF_MEAN|2.47||0.93|TWO_SIDED|95.0|-5.33|4.88|||Mixed Models Analysis|||||4.88|-5.33|0.93
71116323|NCT02333396|141739239|SUPERIORITY||Beta Estimate|-0.35|STANDARD_ERROR_OF_MEAN|1.29||0.79|TWO_SIDED|95.0|-3.02|2.31|||Mixed Models Analysis|||||2.31|-3.02|0.79
71116324|NCT02333396|141739242|SUPERIORITY||Beta Estimate|0.49|STANDARD_ERROR_OF_MEAN|1.03||0.64|TWO_SIDED|95.0|-2.62|1.64|||Mixed Models Analysis|||||1.64|-2.62|0.64
71116325|NCT02333396|141739243|SUPERIORITY||Beta Estimate|-0.9|STANDARD_ERROR_OF_MEAN|1.03||0.39|TWO_SIDED|95.0|-3.02|1.22|||Mixed Models Analysis|||||1.22|-3.02|0.39
71116326|NCT02333396|141739245|SUPERIORITY||Beta Estiamte|1.72|STANDARD_ERROR_OF_MEAN|1.1||0.13|TWO_SIDED|95.0|-0.55|3.98|||Mixed Models Analysis|||||3.98|-0.55|0.13
71116327|NCT02333396|141739246|SUPERIORITY||Beta Estimate|1.72|STANDARD_ERROR_OF_MEAN|1.1||0.13|TWO_SIDED|95.0|-0.55|3.98|||Mixed Models Analysis|||||3.98|-0.55|0.13
71116328|NCT01108731|141739248|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||General Linear Model (GLM)|||||||<0.05
71116329|NCT01108731|141739249|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||General Linear Model (GLM)|||||||<0.05
71116330|NCT01108731|141739250|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71116331|NCT01892722|141739252|SUPERIORITY||||||<|0.001|||||||Negative binomial regression model|||||||<0.001
71116332|NCT01252186|141739259|NON_INFERIORITY_OR_EQUIVALENCE|A conclusion of non-inferiority was reached if the lower limit of the confidence interval for the comparison (active control minus 91-day Levonorgestrel) was greater than -0.13 nmol/L (130 pmol/L).|Treatment Difference|-11.54||||0.958|TWO_SIDED|95.0|-440.1|417.0|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The primary endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||417.0|-440.1|0.958
71116333|NCT01252186|141739259|NON_INFERIORITY_OR_EQUIVALENCE|A conclusion of non-inferiority was reached if the lower limit of the confidence interval for the comparison (active control minus 91-day Levonorgestrel) was greater than -0.13 nmol/L (130 pmol/L).|Treatment Difference|422.76||||0.06|TWO_SIDED|95.0|-18.3|863.8|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The primary endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||863.8|-18.3|0.060
71116334|NCT01252186|141739260|SUPERIORITY_OR_OTHER||Treatment Difference|-14.31||||0.745|TWO_SIDED|95.0|-100.8|72.2|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||72.2|-100.8|0.745
71116335|NCT01252186|141739260|SUPERIORITY_OR_OTHER||Treatment Difference|71.31||||0.115|TWO_SIDED|95.0|-17.5|160.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||160.1|-17.5|0.115
71116336|NCT01252186|141739261|SUPERIORITY_OR_OTHER||Treatment Difference|-17.14||||0.782|TWO_SIDED|95.0|-139.4|105.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||105.1|-139.4|0.782
71075031|NCT04526574|141659101|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.88|||||TWO_SIDED|95.0|0.78|0.98||||||Serotype 19A: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.98|0.78|
71075032|NCT04526574|141659101|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.89|||||TWO_SIDED|95.0|0.78|1.01||||||Serotype 19F: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||1.01|0.78|
71075033|NCT04526574|141659101|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.75|||||TWO_SIDED|95.0|0.62|0.9||||||Serotype 22F: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.90|0.62|
70940752|NCT05129592|141381620|SUPERIORITY||Mean Difference (Final Values)|1.97|STANDARD_ERROR_OF_MEAN|4.66||0.965|TWO_SIDED|95.0|-9.25|13.19|||ANCOVA|Sidak's adjusted p-value (df=4)|Nicotine corrective control - Nicotine corrective with both components of coherence|ANCOVA adjusted for baseline consideration of switching||13.19|-9.25|0.965
71075034|NCT04526574|141659101|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.78|||||TWO_SIDED|95.0|0.66|0.92||||||Serotype 23F: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.92|0.66|
71075035|NCT04526574|141659101|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.72|||||TWO_SIDED|95.0|0.62|0.83||||||Serotype 33F: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.83|0.62|
71075036|NCT04526574|141659102|NON_INFERIORITY|NI was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.67 (1.5-fold criterion).|GMR|1.07|||||TWO_SIDED|95.0|0.97|1.17||||||A/H1N1: GMRs (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 2-sided CIs were calculated by exponentiating the difference of LS means for the HAI titers and the corresponding CIs based on the regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed HAI titers, and prior pneumococcal vaccination status.||1.17|0.97|
71075037|NCT04526574|141659102|NON_INFERIORITY|NI was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.67 (1.5-fold criterion).|GMR|0.98|||||TWO_SIDED|95.0|0.89|1.08||||||A/H3N2: GMRs (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 2-sided CIs were calculated by exponentiating the difference of LS means for the HAI titers and the corresponding CIs based on the regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed HAI titers, and prior pneumococcal vaccination status.||1.08|0.89|
71075038|NCT04526574|141659102|NON_INFERIORITY|NI was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.67 (1.5-fold criterion).|GMR|1.0|||||TWO_SIDED|95.0|0.93|1.08||||||B/Victoria: GMRs (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 2-sided CIs were calculated by exponentiating the difference of LS means for the HAI titers and the corresponding CIs based on the regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed HAI titers, and prior pneumococcal vaccination status.||1.08|0.93|
71075039|NCT04526574|141659102|NON_INFERIORITY|NI was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.67 (1.5-fold criterion).|GMR|0.95|||||TWO_SIDED|95.0|0.87|1.03||||||B/Phuket: GMRs (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 2-sided CIs were calculated by exponentiating the difference of LS means for the HAI titers and the corresponding CIs based on the regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed HAI titers, and prior pneumococcal vaccination status.||1.03|0.87|
71116337|NCT01252186|141739261|SUPERIORITY_OR_OTHER||Treatment Difference|97.09||||0.131|TWO_SIDED|95.0|-29.2|223.4|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||223.4|-29.2|0.131
71116338|NCT01252186|141739262|SUPERIORITY_OR_OTHER||Treatment Difference|-0.04||||0.428|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.1|-0.1|0.428
70853550|NCT02720107|141195164|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||CD4+ Effector memory T cells||||< 0.0001
70853551|NCT02720107|141195164|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||CD8+ Naïve T cells||||< 0.0001
71075040|NCT01524783|141659134|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|95.0|0.35|0.67|||Log Rank|||||0.67|0.35|<0.001
71075041|NCT01524783|141659135|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.259|TWO_SIDED|95.0|0.66|1.24|||Log Rank|||||1.24|0.66|0.259
71075042|NCT01524783|141659138|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.073|TWO_SIDED|95.0|0.5|1.1|||Log Rank|||||1.10|0.50|0.073
71075043|NCT01524783|141659141|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.02||||0.539|TWO_SIDED|95.0|0.65|1.61|||Log Rank|||||1.61|0.65|0.539
71075044|NCT01782352|141659155|SUPERIORITY||Hazard Ratio (HR)|1.02|||<|0.05|TWO_SIDED|95.0|0.82|1.27|||Regression, Cox|||||1.27|0.82|<0.05
71075045|NCT01782352|141659155|SUPERIORITY||Hazard Ratio (HR)|0.94|||<|0.05|TWO_SIDED|95.0|0.76|1.17|||Regression, Cox|||||1.17|0.76|<0.05
71075046|NCT01782352|141659156|SUPERIORITY||Hazard Ratio (HR)|1.21|||<|0.05|TWO_SIDED|95.0|0.86|1.7|||Regression, Cox|||||1.70|0.86|<0.05
71075047|NCT01782352|141659156|SUPERIORITY||Hazard Ratio (HR)|0.84|||<|0.05|TWO_SIDED|95.0|0.59|1.17|||Regression, Cox|||||1.17|0.59|<0.05
71075048|NCT01782352|141659157|SUPERIORITY||Hazard Ratio (HR)|1.23|||<|0.05|TWO_SIDED|95.0|0.81|1.84|||Regression, Cox|||||1.84|0.81|<0.05
71075049|NCT01782352|141659157|SUPERIORITY||Hazard Ratio (HR)|0.72|||<|0.05|TWO_SIDED|95.0|0.48|1.09|||Regression, Cox|||||1.09|0.48|<0.05
71075050|NCT01782352|141659158|SUPERIORITY||Hazard Ratio (HR)|1.09|||<|0.05|TWO_SIDED|95.0|0.86|1.37|||Regression, Cox|||||1.37|0.86|<0.05
71075051|NCT01782352|141659158|SUPERIORITY||Hazard Ratio (HR)|0.93|||<|0.05|TWO_SIDED|95.0|0.73|1.17|||Regression, Cox|||||1.17|0.73|<0.05
71075052|NCT01782352|141659159|SUPERIORITY||Hazard Ratio (HR)|0.63|||<|0.05|TWO_SIDED|95.0|0.33|1.21|||Regression, Cox|||||1.21|0.33|<0.05
71075053|NCT01782352|141659159|SUPERIORITY||Hazard Ratio (HR)|1.05|||<|0.05|TWO_SIDED|95.0|0.56|1.97|||Regression, Cox|||||1.97|0.56|<0.05
71075054|NCT01782352|141659160|SUPERIORITY||Hazard Ratio (HR)|0.93|||<|0.05|TWO_SIDED|95.0|0.69|1.25|||Regression, Cox|||||1.25|0.69|<0.05
71075055|NCT01782352|141659160|SUPERIORITY||Hazard Ratio (HR)|0.9|||<|0.05|TWO_SIDED|95.0|0.67|1.21|||Regression, Cox|||||1.21|0.67|<0.05
71075056|NCT02267135|141659164|SUPERIORITY_OR_OTHER_LEGACY||Difference between percentages|51.0|||<|0.001|TWO_SIDED|95.0|37.0|65.0|||Cochran-Mantel-Haenszel|adjusted for body weight (\< 90 kg, ≥ 90 kg)||||65|37|<0.001
71075057|NCT01554176|141659226|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.7||||0.679|TWO_SIDED|95.0|-3.8|2.5||cLDA model included terms for treatment, time, the interaction of time by treatment, severity of disease (Hamilton Depression Rating Scale, 17-items \[HAM-D17\] ≤20, \>20) and insomnia severity index (ISI ≤14, \>14).|cLDA|||Number of participants included for calculation of mean ± SD baseline and mean ± SD change from baseline MADRS Total Score is 119. Constrained longitudinal data analysis (cLDA) model uses efficacy Full Analysis Set (FAS) population (number of participants: filorexant 10 mg - 64, placebo - 64; total number of participants in cLDA analysis - 128).||2.5|-3.8|0.679
71075058|NCT01554176|141659227|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.3||||0.82|TWO_SIDED|95.0|-3.2|2.5||cLDA model included terms for treatment, time, the interaction of time by treatment, severity of disease (Hamilton Depression Rating Scale, 17-items \[HAM-D17\] ≤20, \>20) and insomnia severity index (ISI ≤14, \>14).|cLDA|||Pairwise Comparison: Filorexant 10 mg vs. Placebo||2.5|-3.2|0.820
71075059|NCT01554176|141659228|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.3||||0.701|TWO_SIDED|95.0|-1.9|1.3||cLDA model included terms for treatment, time, the interaction of time by treatment, severity of disease (Hamilton Depression Rating Scale, 17-items \[HAM-D17\] ≤20, \>20) and insomnia severity index (ISI ≤14, \>14).|cLDA|||Pairwise Comparison: Filorexant 10 mg vs. Placebo||1.3|-1.9|0.701
71075060|NCT01554176|141659229|SUPERIORITY_OR_OTHER||Estimated Odds Ratio|2.5||||0.0965|TWO_SIDED|95.0|0.8|7.3||Generalized linear mixed effects model included terms for treatment, time, treatment-by-time interaction.|Generalized Linear Mixed Effects Model|||Pairwise Comparison: Filorexant 10 mg vs. Placebo||7.3|0.8|0.0965
71075061|NCT01554176|141659230|SUPERIORITY_OR_OTHER||Difference in percentage incidence|15.6|||||TWO_SIDED|95.0|-0.9|31.4||||Between-group comparison of AE incident rate||Estimated parameter is between-group difference in percentage of participants with an AE = percentage (filorexant 10 mg) - percentage (placebo) for participants with one or more AE.||31.4|-0.9|
71075062|NCT01554176|141659231|SUPERIORITY_OR_OTHER||Difference in percentage incidence|0.0|||||TWO_SIDED|95.0|-7.0|7.0||||Between-group comparison of incidence rate of drug discontinuation due to AE||Estimated parameter is between-group difference in percentage of participants discontinued from study drug due to an AE = percentage (filorexant 10 mg) - percentage (placebo).||7|-7|
71075063|NCT01085136|141659234|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.61||||0.003|TWO_SIDED|95.0|0.44|0.85||P-value is calculated from two-sided stratified log-rank test|stratified log-rank test|||Hazard ratio is calculated from Cox proportional hazard model with treatment as the only factor, stratified by gender and maximum duration of erlotinib or gefitinib (\<6 months vs \>=6 months).||0.85|0.44|0.0030
71075064|NCT01085136|141659236|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.7905|TWO_SIDED|95.0|0.76|1.44|||Stratified log-rank test.|P-value is calculated from two-sided stratified log-rank test.||Hazard ratio was calculated from Cox proportional hazard model with treatment as the only factor, stratified by gender and maximum duration of erlotinib or gefitinib (\<6 months vs \>=6 months).||1.44|0.76|0.7905
71075065|NCT01085136|141659238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.98||||0.0065|TWO_SIDED|95.0|1.357|6.543|||Regression, Logistic|||Odds ratio, 95% Confidence Interval (CI) and p-value (two-sided) from logistic regression stratified for maximum treatment duration of prior erlotinib or gefitinib (\>=6 months vs \<6 months) and gender.||6.543|1.357|0.0065
71075066|NCT02440854|141659268|OTHER|||||||0.002|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||0.002
71075067|NCT02440854|141659268|OTHER|||||||0.014|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||0.014
70940753|NCT05129592|141381620|SUPERIORITY||Mean Difference (Final Values)|1.57|STANDARD_ERROR_OF_MEAN|4.44||0.979|TWO_SIDED|95.0|-9.13|12.27|||ANCOVA|Sidak's adjusted p-value (df=4)||ANCOVA adjusted for baseline consideration of switching|Nicotine corrective with causal explanation - Nicotine corrective with both components of coherence|12.27|-9.13|0.979
70940754|NCT05129592|141381620|SUPERIORITY||Mean Difference (Final Values)|4.07|STANDARD_ERROR_OF_MEAN|4.37||0.73|TWO_SIDED|95.0|-6.46|14.59|||ANCOVA|Sidak's adjusted p-value (df=4)||ANCOVA adjusted for baseline consideration of switching|Nicotine corrective with reason for misperception - Nicotine corrective with both components of coherence|14.59|-6.46|0.73
70940755|NCT00609245|141381634|SUPERIORITY_OR_OTHER|||||||0.016|||||||ANOVA|||||||0.016
71075068|NCT02440854|141659268|OTHER|||||||0.246|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||0.246
71075069|NCT02440854|141659268|OTHER|||||||0.103|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||0.103
71075070|NCT02440854|141659268|OTHER|||||||0.004|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||0.004
71075071|NCT02440854|141659268|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
71075072|NCT02440854|141659268|OTHER|||||||0.012|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||0.012
70940756|NCT01234675|141381635|SUPERIORITY||Paired difference|4.6||||0.424|TWO_SIDED|95.0|-7.3|16.6|||Paired T test|||||16.6|-7.3|0.424
71075073|NCT02440854|141659268|OTHER|||||||0.024|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||0.024
71075074|NCT02440854|141659268|OTHER|||||||0.009|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.009
71075075|NCT02440854|141659268|OTHER|||||||0.008|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.008
71075076|NCT02440854|141659269|OTHER|||||||0.027|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||0.027
71075077|NCT02440854|141659269|OTHER|||||||0.03|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||0.030
71116339|NCT01252186|141739262|SUPERIORITY_OR_OTHER||Treatment Difference|-0.16||||0.002|TWO_SIDED|95.0|-0.3|-0.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||-0.1|-0.3|0.002
70940757|NCT01234675|141381636|SUPERIORITY||Paired difference|-6.1||||0.049|TWO_SIDED|95.0|-12.2|-0.04|||Paired T test|||||-0.04|-12.2|0.049
70940758|NCT01234675|141381637|SUPERIORITY||Paired difference|22.6||||0.056|TWO_SIDED|95.0|-0.6|45.8|||Paired T test|||||45.8|-0.6|0.056
71075078|NCT02440854|141659269|OTHER|||||||0.351|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||0.351
71075079|NCT02440854|141659269|OTHER|||||||0.143|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||0.143
71075080|NCT02440854|141659269|OTHER|||||||0.163|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||0.163
71075081|NCT02440854|141659269|OTHER|||||||0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||0.001
71075082|NCT02440854|141659269|OTHER|||||||0.003|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||0.003
71075083|NCT02440854|141659269|OTHER|||||||0.036|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||0.036
71075084|NCT02440854|141659269|OTHER|||||||0.043|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.043
71075085|NCT02440854|141659269|OTHER|||||||0.04|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.040
71075086|NCT02440854|141659270|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||<0.001
71075087|NCT02440854|141659270|OTHER|||||||0.003|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||0.003
71075088|NCT02440854|141659270|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||<0.001
71075089|NCT02440854|141659270|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||<0.001
71075090|NCT02440854|141659270|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||<0.001
71075091|NCT02440854|141659270|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
71075092|NCT02440854|141659270|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||<0.001
71075093|NCT02440854|141659270|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||<0.001
71075094|NCT02440854|141659270|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||<0.001
71075095|NCT02440854|141659270|OTHER|||||||0.163|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.163
71075096|NCT02440854|141659271|OTHER|||||||0.003|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||0.003
71075097|NCT02440854|141659271|OTHER|||||||0.009|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||0.009
71075098|NCT02440854|141659271|OTHER|||||||0.012|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||0.012
71075099|NCT02440854|141659271|OTHER|||||||0.332|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||0.332
71075100|NCT02440854|141659271|OTHER|||||||0.029|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||0.029
71075101|NCT02440854|141659271|OTHER|||||||0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||0.001
71075102|NCT02440854|141659271|OTHER|||||||0.177|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||0.177
71075103|NCT02440854|141659271|OTHER|||||||0.436|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||0.436
71075104|NCT02440854|141659271|OTHER|||||||0.302|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.302
71075105|NCT02440854|141659271|OTHER|||||||0.291|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.291
70853552|NCT02720107|141195164|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||CD8+ Central memory T cells||||< 0.0001
71075106|NCT02440854|141659272|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||<0.001
71075107|NCT02440854|141659272|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||<0.001
71075108|NCT02440854|141659272|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||<0.001
71075109|NCT02440854|141659272|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||<0.001
71075110|NCT02440854|141659272|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||<0.001
71075111|NCT02440854|141659272|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
71075112|NCT02440854|141659272|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||<0.001
71116340|NCT01252186|141739263|SUPERIORITY_OR_OTHER||Treatment Difference|-0.01||||0.868|TWO_SIDED|95.0|-0.2|0.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.1|-0.2|0.868
71116341|NCT01252186|141739263|SUPERIORITY_OR_OTHER||Treatment Difference|0.2||||0.012|TWO_SIDED|95.0|0.0|0.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.3|0.0|0.012
71116342|NCT01252186|141739264|SUPERIORITY_OR_OTHER||Treatment Difference|0.09||||0.317|TWO_SIDED|95.0|-0.1|0.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.3|-0.1|0.317
71116343|NCT01252186|141739264|SUPERIORITY_OR_OTHER||Treatment Difference|-0.16||||0.081|TWO_SIDED|95.0|-0.4|0.0|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.0|-0.4|0.081
71075113|NCT02440854|141659272|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||<0.001
71075114|NCT02440854|141659272|OTHER|||||||0.002|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.002
71116344|NCT01252186|141739265|SUPERIORITY_OR_OTHER||Treatment Difference|-0.004||||0.331|TWO_SIDED|95.0|-0.013|0.004|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.004|-0.013|0.331
71075115|NCT02440854|141659272|OTHER|||||||0.025|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.025
71075116|NCT02440854|141659273|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||<0.001
71075117|NCT02440854|141659273|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||<0.001
71075118|NCT02440854|141659273|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||<0.001
71075119|NCT02440854|141659273|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||<0.001
71075120|NCT02440854|141659273|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||<0.001
71075121|NCT02440854|141659273|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
71075122|NCT02440854|141659273|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||<0.001
71075123|NCT02440854|141659273|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||<0.001
71075124|NCT02440854|141659273|OTHER|||||||0.003|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.003
71075125|NCT02440854|141659273|OTHER|||||||0.025|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.025
71075126|NCT02440854|141659274|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||<0.001
71075127|NCT02440854|141659274|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||<0.001
71075128|NCT02440854|141659274|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||<0.001
71075129|NCT02440854|141659274|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||<0.001
71075130|NCT02440854|141659274|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||<0.001
71075131|NCT02440854|141659274|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
71075132|NCT02440854|141659274|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||<0.001
71075133|NCT02440854|141659274|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||<0.001
71075134|NCT02440854|141659274|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||<0.001
71075135|NCT02440854|141659274|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||<0.001
71075136|NCT02440854|141659275|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||<0.001
71075137|NCT02440854|141659275|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||<0.001
71075138|NCT02440854|141659275|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||<0.001
71075139|NCT02440854|141659275|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||<0.001
71075140|NCT02440854|141659275|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||<0.001
71075141|NCT02440854|141659275|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
71075142|NCT02440854|141659275|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||<0.001
71075143|NCT02440854|141659275|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||<0.001
71075144|NCT02440854|141659275|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||<0.001
71075145|NCT02440854|141659275|OTHER|||||||0.002|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.002
71075146|NCT02440854|141659276|OTHER|||||||0.022|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||0.022
71075147|NCT02440854|141659276|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||<0.001
71075148|NCT02440854|141659276|OTHER|||||||0.004|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||0.004
71116345|NCT01252186|141739265|SUPERIORITY_OR_OTHER||Treatment Difference|-0.006||||0.173|TWO_SIDED|95.0|-0.015|0.003|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.003|-0.015|0.173
71116346|NCT01252186|141739266|SUPERIORITY_OR_OTHER||Treatment Difference|-0.57||||0.194|TWO_SIDED|95.0|-1.4|0.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.3|-1.4|0.194
71116347|NCT01252186|141739266|SUPERIORITY_OR_OTHER||Treatment Difference|-0.02||||0.967|TWO_SIDED|95.0|-0.9|0.9|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.9|-0.9|0.967
71075149|NCT02440854|141659276|OTHER|||||||0.032|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||0.032
71116348|NCT01252186|141739267|SUPERIORITY_OR_OTHER||Treatment Difference|1.09||||0.648|TWO_SIDED|95.0|-3.6|5.8|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||5.8|-3.6|0.648
71075150|NCT02440854|141659276|OTHER|||||||0.066|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||0.066
71075151|NCT02440854|141659276|OTHER|||||||0.042|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||0.042
71075152|NCT02440854|141659276|OTHER|||||||0.045|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||0.045
71075153|NCT02440854|141659276|OTHER|||||||0.014|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||0.014
71075154|NCT02440854|141659276|OTHER|||||||0.015|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.015
71075155|NCT02440854|141659276|OTHER|||||||0.462|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.462
71075156|NCT02440854|141659277|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||<0.001
71075157|NCT02440854|141659277|OTHER|||||||0.004|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||0.004
71075158|NCT02440854|141659277|OTHER|||||||0.008|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||0.008
71075159|NCT02440854|141659277|OTHER|||||||0.315|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||0.315
71075160|NCT02440854|141659277|OTHER|||||||0.237|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||0.237
71075161|NCT02440854|141659277|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
71075162|NCT02440854|141659277|OTHER|||||||0.002|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||0.002
71075163|NCT02440854|141659277|OTHER|||||||0.004|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||0.004
71075164|NCT02440854|141659277|OTHER|||||||0.01|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.010
71075165|NCT02440854|141659277|OTHER|||||||0.683|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.683
71075166|NCT02440854|141659278|OTHER|||||||0.062|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||0.062
71075167|NCT02440854|141659278|OTHER|||||||0.062|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||0.062
71075168|NCT02440854|141659278|OTHER|||||||0.027|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||0.027
71075169|NCT02440854|141659278|OTHER|||||||0.17|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||0.170
71075170|NCT02440854|141659278|OTHER|||||||0.271|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||0.271
71075171|NCT02440854|141659278|OTHER|||||||0.002|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||0.002
71075172|NCT02440854|141659278|OTHER|||||||0.003|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||0.003
71075173|NCT02440854|141659278|OTHER|||||||0.157|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||0.157
71075174|NCT02440854|141659278|OTHER|||||||0.064|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.064
71075175|NCT02440854|141659278|OTHER|||||||0.439|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.439
71075176|NCT02440854|141659279|OTHER|||||||0.388|||||||McNemar|||Shift in patient distribution between baseline and Month 2 post-baseline, according to problems/no problems.||||0.388
70853553|NCT02720107|141195164|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||CD8+ Effector memory T cells||||< 0.0001
70853554|NCT02720107|141195164|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||TH17 central memory cells||||< 0.0001
71075177|NCT02440854|141659279|OTHER|||||||0.006|||||||McNemar|||Shift in patient distribution between baseline and Month 4 post-baseline, according to problems/no problems.||||0.006
71075178|NCT02440854|141659279|OTHER|||||||0.077|||||||McNemar|||Shift in patient distribution between baseline and Month 6 post-baseline, according to problems/no problems.||||0.077
71075179|NCT02440854|141659279|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 8 post-baseline, according to problems/no problems.||||>0.999
71075180|NCT02440854|141659279|OTHER|||||||0.508|||||||McNemar|||Shift in patient distribution between baseline and Month 10 post-baseline, according to problems/no problems.||||0.508
71075181|NCT02440854|141659279|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 12 post-baseline, according to problems/no problems.||||>0.999
71075182|NCT02440854|141659279|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 18 post-baseline, according to problems/no problems.||||>0.999
71075183|NCT02440854|141659279|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 24 post-baseline, according to problems/no problems.||||>0.999
71075184|NCT02440854|141659279|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 30 post-baseline, according to problems/no problems.||||>0.999
71075185|NCT02440854|141659279|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 36 post-baseline, according to problems/no problems.||||>0.999
71075186|NCT02440854|141659280|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 2 post-baseline, according to problems/no problems.||||>0.999
71116349|NCT01252186|141739267|SUPERIORITY_OR_OTHER||Treatment Difference|1.68||||0.496|TWO_SIDED|95.0|-3.2|6.6|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||6.6|-3.2|0.496
70940759|NCT01234675|141381638|SUPERIORITY||Paired difference|-6.1||||0.683|TWO_SIDED|95.0|-12.5|18.5|||Paired T test|||||18.5|-12.5|0.683
71116350|NCT01252186|141739268|SUPERIORITY_OR_OTHER||Treatment Difference|8.71||||0.405|TWO_SIDED|95.0|-11.9|29.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||29.3|-11.9|0.405
70940760|NCT01234675|141381639|SUPERIORITY||Paired difference|-1.502||||0.155|TWO_SIDED|95.0|-59.1|10.4|||Paired T test|||||10.4|-59.1|0.155
71075187|NCT02440854|141659280|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 4 post-baseline, according to problems/no problems.||||>0.999
71075188|NCT02440854|141659280|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 6 post-baseline, according to problems/no problems.||||>0.999
71075189|NCT02440854|141659280|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 8 post-baseline, according to problems/no problems.||||>0.999
71075190|NCT02440854|141659280|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 10 post-baseline, according to problems/no problems.||||>0.999
71075191|NCT02440854|141659280|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 12 post-baseline, according to problems/no problems.||||>0.999
71075192|NCT02440854|141659280|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 18 post-baseline, according to problems/no problems.||||>0.999
71075193|NCT02440854|141659281|OTHER|||||||0.774|||||||McNemar|||Shift in patient distribution between baseline and Month 2 post-baseline, according to problems/no problems.||||0.774
71075194|NCT02440854|141659281|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 4 post-baseline, according to problems/no problems.||||>0.999
71075195|NCT02440854|141659281|OTHER|||||||0.607|||||||McNemar|||Shift in patient distribution between baseline and Month 6 post-baseline, according to problems/no problems.||||0.607
71075196|NCT02440854|141659281|OTHER|||||||0.774|||||||McNemar|||Shift in patient distribution between baseline and Month 8 post-baseline, according to problems/no problems.||||0.774
71075197|NCT02440854|141659281|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 10 post-baseline, according to problems/no problems.||||>0.999
71075198|NCT02440854|141659281|OTHER|||||||0.453|||||||McNemar|||Shift in patient distribution between baseline and Month 12 post-baseline, according to problems/no problems.||||0.453
71075199|NCT02440854|141659281|OTHER|||||||0.688|||||||McNemar|||Shift in patient distribution between baseline and Month 18 post-baseline, according to problems/no problems.||||0.688
71075200|NCT02440854|141659281|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 24 post-baseline, according to problems/no problems.||||>0.999
71075201|NCT02440854|141659281|OTHER|||||||0.25|||||||McNemar|||Shift in patient distribution between baseline and Month 30 post-baseline, according to problems/no problems.||||0.250
71075202|NCT02440854|141659281|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 36 post-baseline, according to problems/no problems.||||>0.999
71075203|NCT02440854|141659282|OTHER|||||||0.077|||||||McNemar|||Shift in patient distribution between baseline and Month 2 post-baseline, according to problems/no problems.||||0.077
71075204|NCT02440854|141659282|OTHER||||||<|0.001|||||||McNemar|||Shift in patient distribution between baseline and Month 4 post-baseline, according to problems/no problems.||||<0.001
71075205|NCT02440854|141659282|OTHER|||||||0.006|||||||McNemar|||Shift in patient distribution between baseline and Month 6 post-baseline, according to problems/no problems.||||0.006
71116351|NCT01252186|141739268|SUPERIORITY_OR_OTHER||Treatment Difference|28.95||||0.008|TWO_SIDED|95.0|7.7|50.2|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||50.2|7.7|0.008
71116352|NCT01252186|141739269|SUPERIORITY_OR_OTHER||Treatment Difference|3.3||||0.425|TWO_SIDED|195.0|-4.9|11.5|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||11.5|-4.9|0.425
71116353|NCT01252186|141739269|SUPERIORITY_OR_OTHER||Treatment Difference|8.76||||0.041|TWO_SIDED|95.0|0.3|17.2|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||17.2|0.3|0.041
71116354|NCT01252186|141739270|SUPERIORITY_OR_OTHER||Treatment Difference|-2.4||||0.088|TWO_SIDED|95.0|-5.2|0.4|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.4|-5.2|0.088
70853555|NCT02908490|141195225|SUPERIORITY|Given the cross-over design, analyses included a random effects model for within-subject comparisons of sildenafil versus placebo periods, adjusting for the baseline FMD within that period and a term for treatment order.|Slope|-1.42||||0.185|TWO_SIDED|95.0|-3.54|0.68||The a priori threshold for statistical significance was \<0.05.|Mixed Models Analysis|||||0.68|-3.54|0.185
71075206|NCT02440854|141659282|OTHER|||||||0.344|||||||McNemar|||Shift in patient distribution between baseline and Month 8 post-baseline, according to problems/no problems.||||0.344
71075207|NCT02440854|141659282|OTHER|||||||0.146|||||||McNemar|||Shift in patient distribution between baseline and Month 10 post-baseline, according to problems/no problems.||||0.146
71075208|NCT02440854|141659282|OTHER|||||||0.18|||||||McNemar|||Shift in patient distribution between baseline and Month 12 post-baseline, according to problems/no problems.||||0.180
71075209|NCT02440854|141659282|OTHER|||||||0.289|||||||McNemar|||Shift in patient distribution between baseline and Month 18 post-baseline, according to problems/no problems.||||0.289
71075210|NCT02440854|141659282|OTHER|||||||0.125|||||||McNemar|||Shift in patient distribution between baseline and Month 24 post-baseline, according to problems/no problems.||||0.125
71116355|NCT01252186|141739270|SUPERIORITY_OR_OTHER||Treatment Difference|-3.19||||0.028|TWO_SIDED|95.0|-6.0|-0.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||-0.3|-6.0|0.028
71116356|NCT01252186|141739271|SUPERIORITY_OR_OTHER||Treatment Difference|1.75||||0.631|TWO_SIDED|95.0|-5.4|8.9|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||8.9|-5.4|0.631
71116357|NCT01252186|141739271|SUPERIORITY_OR_OTHER||Treatment Difference|3.73||||0.323|TWO_SIDED|95.0|-3.7|11.2|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||11.2|-3.7|0.323
71116358|NCT01252186|141739272|SUPERIORITY_OR_OTHER||Treatment Difference|-0.86||||0.783|TWO_SIDED|595.0|-7.0|5.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||5.3|-7.0|0.783
71075211|NCT02440854|141659282|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 30 post-baseline, according to problems/no problems.||||>0.999
71075212|NCT02440854|141659282|OTHER|||||||0.5|||||||McNemar|||Shift in patient distribution between baseline and Month 36 post-baseline, according to problems/no problems.||||0.500
71075213|NCT02440854|141659283|OTHER|||||||0.21|||||||McNemar|||Shift in patient distribution between baseline and Month 2 post-baseline, according to problems/no problems.||||0.210
71075214|NCT02440854|141659283|OTHER|||||||0.263|||||||McNemar|||Shift in patient distribution between baseline and Month 4 post-baseline, according to problems/no problems.||||0.263
71075215|NCT02440854|141659283|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 6 post-baseline, according to problems/no problems.||||>0.999
71075216|NCT02440854|141659283|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 8 post-baseline, according to problems/no problems.||||>0.999
71075217|NCT02440854|141659283|OTHER|||||||0.629|||||||McNemar|||Shift in patient distribution between baseline and Month 10 post-baseline, according to problems/no problems.||||0.629
71075218|NCT02440854|141659283|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 12 post-baseline, according to problems/no problems.||||>0.999
71075219|NCT02440854|141659283|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 18 post-baseline, according to problems/no problems.||||>0.999
71075220|NCT02440854|141659283|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 24 post-baseline, according to problems/no problems.||||>0.999
71075221|NCT02440854|141659283|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 30 post-baseline, according to problems/no problems.||||>0.999
71075222|NCT02440854|141659283|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 36 post-baseline, according to problems/no problems.||||>0.999
71075223|NCT02440854|141659284|OTHER|||||||0.098|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 2-month post-baseline.||||0.098
71075224|NCT02440854|141659284|OTHER|||||||0.359|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 4-month post-baseline.||||0.359
70853556|NCT02908490|141195226|SUPERIORITY|Given the cross-over design, analyses included a random effects model for within-subject comparisons of sildenafil versus placebo periods, adjusting for the baseline EndoPAT within that period and a term for treatment order.|Slope|0.2||||0.003|TWO_SIDED|95.0|0.069|0.331||The a priori threshold for statistical significance was \<0.05.|Mixed Models Analysis|||||0.331|0.069|0.003
71075225|NCT02440854|141659284|OTHER|||||||0.393|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 6-month post-baseline.||||0.393
70940761|NCT01234675|141381640|SUPERIORITY||Paired difference|-1.0||||0.805|TWO_SIDED|95.0|-9.8|7.8|||Paired T test|||||7.8|-9.8|0.805
71075226|NCT02440854|141659284|OTHER|||||||0.055|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 8-month post-baseline.||||0.055
71075227|NCT02440854|141659284|OTHER|||||||0.124|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 10-month post-baseline.||||0.124
71075228|NCT02440854|141659284|OTHER|||||||0.376|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 12-month post-baseline.||||0.376
71075229|NCT02440854|141659284|OTHER|||||||0.033|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 18-month post-baseline.||||0.033
71075230|NCT02440854|141659284|OTHER|||||||0.048|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 24-month post-baseline.||||0.048
71075231|NCT02440854|141659284|OTHER|||||||0.071|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 30-month post-baseline.||||0.071
71075232|NCT02440854|141659284|OTHER|||||||0.848|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 36-month post-baseline.||||0.848
71075233|NCT00316914|141659304|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||A priori threshold for the p-value is 0.05 and there was no adjustment for multiple comparisons.|Chi-squared|||Comparison in Percentage of Patients With Oxaliplatin-induced Grade 2+ Chronic Neuropathic Adverse Event between Arms||||0.038
71075234|NCT00316914|141659305|SUPERIORITY_OR_OTHER|||||||0.0503||95.0|||||Log Rank|||Comparison of time to Onset of Grade 2+ Chronic Neurotoxicity between Arms||||0.0503
71075235|NCT00316914|141659306|SUPERIORITY_OR_OTHER|||||||0.4048||95.0|||||Log Rank|||Comparison of Time to Onset of Grade 3+ Chronic Neurotoxicity between Arms||||0.4048
71075236|NCT00316914|141659307|SUPERIORITY_OR_OTHER|||||||0.6556||95.0|||||Log Rank|||Comparison of Average Duration of Chronic Neuropathic Toxicity between Arms||||0.6556
71075237|NCT00316914|141659308|SUPERIORITY_OR_OTHER|||||||0.3238||95.0|||||Chi-squared|||Comparison of Percentage of patients discontinuing therapy for chronic neurotoxicity between Arms||||0.3238
71075238|NCT00316914|141659311|SUPERIORITY_OR_OTHER|||||||0.7498||95.0|||||Chi-squared|||Comparison of Percentage of Patients With Acute Neuropathic Adverse Event between Arms||||0.7498
71075239|NCT00316914|141659314|SUPERIORITY_OR_OTHER|||||||0.234||95.0|||||Kruskal-Wallis|||Comparison of Fatigue NOW between two arms||||0.2340
71075240|NCT00316914|141659314|SUPERIORITY_OR_OTHER|||||||0.201||95.0|||||Kruskal-Wallis|||Comparison of Fatigue USUAL between two arms||||0.2010
71075241|NCT00316914|141659314|SUPERIORITY_OR_OTHER|||||||0.9364||95.0|||||Kruskal-Wallis|||Comparison of Fatigue WORST between two arms||||0.9364
71075242|NCT00316914|141659315|SUPERIORITY_OR_OTHER|||||||0.9364||95.0|||||Kruskal-Wallis|||Fatigue WORST||||0.9364
71075243|NCT00316914|141659315|SUPERIORITY_OR_OTHER|||||||0.6275||95.0|||||Kruskal-Wallis|||Walking||||0.6275
71075244|NCT00316914|141659315|SUPERIORITY_OR_OTHER|||||||0.6988||95.0|||||Kruskal-Wallis|||Buttoning Shirt or Tying Laces||||0.6988
71075245|NCT00316914|141659315|SUPERIORITY_OR_OTHER|||||||0.5124||95.0|||||Kruskal-Wallis|||Diarrhea||||0.5124
71075246|NCT00316914|141659315|SUPERIORITY_OR_OTHER|||||||0.3103||95.0|||||Kruskal-Wallis|||Constipation||||0.3103
71075247|NCT00316914|141659315|SUPERIORITY_OR_OTHER|||||||0.8601||95.0|||||Kruskal-Wallis|||Abdominal Cramping||||0.8601
71075248|NCT00316914|141659315|SUPERIORITY_OR_OTHER|||||||0.2439||95.0|||||Kruskal-Wallis|||Bowel Problems with Normal Activity||||0.2439
71075249|NCT00316914|141659315|SUPERIORITY_OR_OTHER|||||||0.9283||95.0|||||Kruskal-Wallis|||Shortness of Breath (Week 2 - Baseline)||||0.9283
71075250|NCT00316914|141659315|SUPERIORITY_OR_OTHER|||||||0.4715||95.0|||||Kruskal-Wallis|||Swallowing (Week 2 - Baseline)||||0.4715
71075251|NCT00316914|141659315|SUPERIORITY_OR_OTHER|||||||0.5105||95.0|||||Kruskal-Wallis|||Numbness in Fingers, Toes (Week 2 - Baseline)||||0.5105
71075252|NCT00316914|141659315|SUPERIORITY_OR_OTHER|||||||0.2181||95.0|||||Kruskal-Wallis|||Tingling in Fingers, Toes (Week 2 - Baseline)||||0.2181
71075253|NCT04105010|141659316|SUPERIORITY||||||<|0.0001|||||||Binomial test against a null|||||||<0.0001
71075254|NCT01075399|141659332|SUPERIORITY_OR_OTHER||Pearson's Correlation Coefficient|0.883|||<|0.001|TWO_SIDED|90.0|0.802|0.929||Significance of probability for no association between the first and second pre-treatment uptake.|Pearson's correlation|||"Primary Tumor SUV max:~The reproducibility of \[F-18\]HX4 uptake in primary tumors was assessed by comparing SUV max of the 1st and 2nd \[F18\]HX4 PET/CT scan.~Estimated power for a range of coefficients of variation (CVs) postulated for the paired differences in SUV values, and for establishing reproducibility within ±20% or ±25%."||0.929|0.802|<0.001
71079430|NCT00482170|141666437|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.22|TWO_SIDED|95.0|0.84|2.08||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.08|0.84|0.220
71075255|NCT01075399|141659332|SUPERIORITY_OR_OTHER||Pearson's Correlation Coefficient|0.887|||<|0.001|TWO_SIDED|90.0|0.792|0.925||Significance of probability for no association between the first and second pre-treatment uptake.|Pearson's correlation|||"Primary Tumor SUV mean:~The reproducibility of \[F-18\]HX4 uptake in primary tumors was assessed by comparing SUV mean of the 1st and 2nd \[F18\]HX4 PET/CT scan.~Estimated power for a range of coefficients of variation (CVs) postulated for the paired differences in SUV values, and for establishing reproducibility within ±20% or ±25%."||0.925|0.792|<0.001
71116359|NCT01252186|141739272|SUPERIORITY_OR_OTHER||Treatment Difference|-2.83||||0.384|TWO_SIDED|95.0|-9.2|3.6|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||3.6|-9.2|0.384
71116360|NCT01252186|141739273|SUPERIORITY_OR_OTHER||Treatment Difference|1.66||||0.572|TWO_SIDED|95.0|-4.1|7.5|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||7.5|-4.1|0.572
70853557|NCT02908490|141195232|SUPERIORITY|Given the cross-over design, analyses included a random effects model for within-subject comparisons of sildenafil versus placebo periods, adjusting for the baseline biomarker within that period and a term for treatment order.|Slope|7.63||||0.061|TWO_SIDED|95.0|-0.36|15.63||The a prior threshold for statistical significance was \<0.05.|Mixed Models Analysis|||||15.63|-0.36|0.061
71075256|NCT01075399|141659332|SUPERIORITY_OR_OTHER||Pearson's Correlation Coefficient|0.945|||<|0.001|TWO_SIDED|90.0|0.904|0.967||Significance of probability for no association between the first and second pre-treatment uptake.|Pearson's correlation|||"Primary Tumor to background SUV ratio:~The reproducibility of \[F-18\]HX4 uptake in primary tumors was assessed by comparing tumor to background SUV ratio (T/B) of the 1st and 2nd \[F18\]HX4 PET/CT scan.~Estimated power for a range of coefficients of variation (CVs) postulated for the paired differences in T/B values, and for establishing reproducibility within ±20% or ±25%."||0.967|0.904|<0.001
71075257|NCT00424021|141659341|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.5|STANDARD_DEVIATION|46.93|||TWO_SIDED|95.0|-8.3|17.3||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||17.3|-8.3|
71075258|NCT00424021|141659342|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.3|STANDARD_DEVIATION|73.16|||TWO_SIDED|95.0|-30.3|9.7||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||9.7|-30.3|
71075259|NCT00424021|141659343|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7|STANDARD_DEVIATION|83.08|||TWO_SIDED|95.0|-27.4|18.0||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||18.0|-27.4|
71075260|NCT00424021|141659344|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.9|STANDARD_DEVIATION|77.04|||TWO_SIDED|95.0|-34.9|7.1||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||7.1|-34.9|
71075261|NCT00424021|141659346|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21|STANDARD_DEVIATION|1.323|||TWO_SIDED|95.0|-0.15|0.57||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||0.57|-0.15|
71075262|NCT00424021|141659347|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|STANDARD_DEVIATION|1.659|||TWO_SIDED|95.0|0.01|0.92||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||0.92|0.01|
71075263|NCT00424021|141659348|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_DEVIATION|1.888|||TWO_SIDED|95.0|-0.02|1.02||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||1.02|-0.02|
71075264|NCT00424021|141659349|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|STANDARD_DEVIATION|1.721|||TWO_SIDED|95.0|-0.01|0.93||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||0.93|-0.01|
71075265|NCT00424021|141659356|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|19.41|||TWO_SIDED|95.0|-5.9|4.7||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||4.7|-5.9|
71075266|NCT00424021|141659357|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.4|STANDARD_DEVIATION|25.79|||TWO_SIDED|95.0|-14.4|-0.3||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||-0.3|-14.4|
71075267|NCT00424021|141659358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.1|STANDARD_DEVIATION|25.31|||TWO_SIDED|95.0|-12.0|1.8||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||1.8|-12.0|
71075268|NCT00424021|141659359|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9|STANDARD_DEVIATION|23.69|||TWO_SIDED|95.0|-8.4|4.6||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||4.6|-8.4|
71075269|NCT03000530|141659416|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001|TWO_SIDED|95.0|-10.2|-3.9|||Mixed Effect Model for Repeated Measures|The Mixed Effect Model for Repeated Measures (MMRM) included the change from baseline in HAM-D total score at each visit as the dependent variables.||||-3.9|-10.2|< 0.0001
71075270|NCT03000530|141659483|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.99||0.0223|TWO_SIDED|95.0|-4.3|-0.3|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 2||-0.3|-4.3|0.0223
71116361|NCT01252186|141739273|SUPERIORITY_OR_OTHER||Treatment Difference|-20.98|||<|0.001|TWO_SIDED|95.0|-27.0|-15.0|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||-15.0|-27.0|<0.001
71116362|NCT01252186|141739274|SUPERIORITY_OR_OTHER||Treatment Difference|-0.42||||0.841|TWO_SIDED|95.0|-4.6|3.7|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||3.7|-4.6|0.841
71116363|NCT01252186|141739274|SUPERIORITY_OR_OTHER||Treatment Difference|-10.53|||<|0.001|TWO_SIDED|95.0|-14.8|-6.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||-6.3|-14.8|<0.001
71116364|NCT01252186|141739275|SUPERIORITY_OR_OTHER||Treatment Difference|-2.11||||0.227|TWO_SIDED|95.0|-5.6|1.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||1.3|-5.6|0.227
70853558|NCT02908490|141195233|SUPERIORITY|Given the cross-over design, analyses included a random effects model for within-subject comparisons of sildenafil versus placebo periods, adjusting for the baseline biomarker within that period and a term for treatment order.|Slope|55.3||||0.011|TWO_SIDED|95.0|12.79|97.81||The a prior threshold for statistical significance was \<0.05.|Mixed Models Analysis|||||97.81|12.79|0.011
70853559|NCT02908490|141195234|SUPERIORITY|Given the cross-over design, analyses included a random effects model for within-subject comparisons of sildenafil versus placebo periods, adjusting for the baseline biomarker within that period and a term for treatment order.|Slope|74.93||||0.077|TWO_SIDED|95.0|-7.98|157.84||The a priori threshold for statistical significance was \<0.05.|Mixed Models Analysis|||||157.84|-7.98|0.077
70853560|NCT03467152|141195243|SUPERIORITY|||||||0.6909||||||Mixed Models for Repeated Measures Analysis (MMRM)|MMRM|||||||0.6909
70853561|NCT03467152|141195244|SUPERIORITY||Odds Ratio (OR)|1.018||||0.8251|TWO_SIDED|95.0|0.695|1.492||Generalized Linear Mixed Models Analysis (GLMM)|GLMM|||||1.492|0.695|0.8251
70853562|NCT03467152|141195245|SUPERIORITY||Odds Ratio (OR)|0.853||||0.3003|TWO_SIDED|95.0|0.584|1.247||Generalized Linear Mixed Models Analysis (GLMM)|GLMM|||||1.247|0.584|0.3003
70853563|NCT03467152|141195246|SUPERIORITY|||||||0.9198||||||Mixed Models for Repeated Measures Analysis (MMRM)|MMRM|||||||0.9198
70853564|NCT03467152|141195247|SUPERIORITY|||||||0.2909|||||||ANCOVA|||||||0.2909
70853565|NCT03467152|141195248|SUPERIORITY|||||||0.6127||||||Mixed Models for Repeated Measures Analysis (MMRM)|MMRM|||||||0.6127
70853566|NCT03467152|141195249|SUPERIORITY|||||||0.878||||||Mixed Models for Repeated Measures Analysis (MMRM)|MMRM|||||||0.8780
70853567|NCT03467152|141195250|SUPERIORITY|||||||0.409||||||Mixed Models for Repeated Measures Analysis (MMRM)|MMRM|||||||0.4090
70853568|NCT03467152|141195251|SUPERIORITY|||||||0.8736||||||Mixed Models for Repeated Measures Analysis (MMRM)|MMRM|||||||0.8736
70853569|NCT01236547|141195259|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.2831|TWO_SIDED|95.0|0.52|1.43||One-sided significance level = 0.1379|Log Rank||Reference arm = placebo|Assuming hazard ratio (pazopanib/placebo) of 0.625 (1-year 19% vs. 35.4%), 1-sided alpha 0.15, logrank test, 80% power, 1 interim analysis, required 71 deaths in 79 eligible patients (88 allowing 10% ineligible) in original design. The protocol was amended for phase II final analysis to be performed after all phase II eligible participants were potentially followed for 3 years with 1-sided alpha 0.1379, providing 77% power. See Limitations and Caveats||1.43|0.52|0.2831
70853570|NCT01236547|141195261|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.688|TWO_SIDED|95.0|0.55|2.67|||Log Rank|One-sided significance level = 0.15|Reference arm = placebo|||2.67|0.55|0.6880
70853571|NCT01236547|141195262|SUPERIORITY|||||||0.1921||||||Two-sided significance level = 0.05|Fisher Exact|||||||0.1921
70853572|NCT01236547|141195263|SUPERIORITY|||||||1||||||Two-sided significance level = 0.05|Fisher Exact|||||||1.00
70853573|NCT01236547|141195264|SUPERIORITY|||||||1|||||||Fisher Exact|Two-sided significance level = 0.05||||||1.00
70853574|NCT04250077|141195265|SUPERIORITY||proportion|0.36923076|STANDARD_ERROR_OF_MEAN|0.16518156||0.02578184|TWO_SIDED|95.0|-0.0021812|0.64531855|||Agresti Caffo proportion comparison|||||0.64531855|-0.0021812|0.02578184
70853575|NCT04250077|141195266|SUPERIORITY||Mean Difference (Net)|20.0454545|STANDARD_ERROR_OF_MEAN|7.62386242||0.00787297|TWO_SIDED|95.0|4.18213496|35.9087741|||t-test, 1 sided|||||35.9087741|4.18213496|0.00787297
70853576|NCT04250077|141195267|SUPERIORITY||Mean Difference (Net)|-39.183333|STANDARD_ERROR_OF_MEAN|15.8274398||0.01387108|TWO_SIDED|95.0|-73.356073|-5.0105927|||t-test, 1 sided|||||-5.0105927|-73.356073|0.01387108
70853577|NCT04250077|141195268|SUPERIORITY||Mean Difference (Net)|8.43728901|STANDARD_ERROR_OF_MEAN|3.28323704||0.00908118|TWO_SIDED|95.0|1.59437702|15.280201|||t-test, 1 sided|||||15.2802010|1.59437702|0.00908118
70853578|NCT04250077|141195269|SUPERIORITY||Mean Difference (Net)|1.47698833|STANDARD_ERROR_OF_MEAN|3.68529034||0.34633293|TWO_SIDED|95.0|-6.1910435|9.14502026|||t-test, 1 sided|||||9.14502026|-6.1910435|0.34633293
70853579|NCT04250077|141195270|SUPERIORITY||Mean Difference (Final Values)|-0.4285714|STANDARD_ERROR_OF_MEAN|2.07315199||0.57872623|TWO_SIDED|95.0|-5.4078121|4.55066924|||t-test, 1 sided|||||4.55066924|-5.4078121|0.57872623
71075271|NCT03000530|141659483|SUPERIORITY||Least Squares Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|1.18||0.001|TWO_SIDED|95.0|-6.4|-1.7|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 3||-1.7|-6.4|0.0010
70940762|NCT01234675|141381641|SUPERIORITY||Paired difference|-1.0||||0.844|TWO_SIDED|95.0|-11.6|9.6|||Paired T test|||||9.6|-11.6|0.844
70940763|NCT01234675|141381642|SUPERIORITY||Paired difference|2.9||||0.509|TWO_SIDED|95.0|-6.4|12.2|||Paired T test|||||12.2|-6.4|0.509
70940764|NCT01234675|141381643|SUPERIORITY||Paired difference|0.32||||0.3|TWO_SIDED|95.0|-0.3|0.6|||Paired T test|||||0.6|-0.3|0.3
70940765|NCT01234675|141381644|SUPERIORITY||Paired difference|-1.03||||0.685|TWO_SIDED|95.0|-8.2|5.6|||Paired T test|||||5.6|-8.2|0.685
71075272|NCT03000530|141659483|SUPERIORITY||Least Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|1.27||0.0233|TWO_SIDED|95.0|-5.5|-0.4|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 4||-0.4|-5.5|0.0233
71075273|NCT03000530|141659483|SUPERIORITY||Least Squares Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|1.37||0.0066|TWO_SIDED|95.0|-6.6|-1.1|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 5||-1.1|-6.6|0.0066
71075274|NCT03000530|141659483|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.4||0.0019|TWO_SIDED|95.0|-7.3|-1.7|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 6||-1.7|-7.3|0.0019
71075275|NCT03000530|141659483|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.53||0.0043|TWO_SIDED|95.0|-7.6|-1.5|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 7||-1.5|-7.6|0.0043
71075276|NCT03000530|141659483|SUPERIORITY||Least Squares Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.54||0.0318|TWO_SIDED|95.0|-6.4|-0.3|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 8||-0.3|-6.4|0.0318
70940766|NCT01234675|141381645|SUPERIORITY||Paired difference|-5.3||||0.349|TWO_SIDED|95.0|-17.0|6.4|||Paired T test|||||6.4|-17.0|0.349
70940767|NCT01234675|141381646|SUPERIORITY||Paired difference|-0.6||||0.305|TWO_SIDED|95.0|-1.8|5.6|||Paired T test|||||5.6|-1.8|0.305
70940768|NCT01234675|141381647|SUPERIORITY||Paired difference|-0.5||||0.425|TWO_SIDED|95.0|-1.8|0.8|||Paired T test|||||0.8|-1.8|0.425
70940769|NCT00331799|141381648|SUPERIORITY_OR_OTHER|||||||0.00365|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Signed Rank test on the difference between the baseline and endpoint score on the CD-RISC.||||0.00365
70940770|NCT02889809|141381649|OTHER||Least Square (LS) Mean Difference|-0.16|||||TWO_SIDED|95.0|-0.462|0.142|||||Analysis was performed using an analysis of covariance (ANCOVA) model adjusting for Baseline growth velocity, age at Visit 1, gender and country.|||0.142|-0.462|
70940771|NCT02889809|141381652|OTHER||LS Mean Difference|0.059|||||TWO_SIDED|95.0|-0.455|0.572|||||Analysis was performed using an ANCOVA model adjusting for Baseline growth velocity, age at Visit 1(wk -16), gender and country|||0.572|-0.455|
70940772|NCT05065918|141381656|SUPERIORITY||Slope|-0.536||||0.448|TWO_SIDED|95.0|-1.929|0.857|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||0.857|-1.929|0.448
70940773|NCT05065918|141381657|SUPERIORITY||Slope|0.99||||0.969|TWO_SIDED|95.0|-1.152|1.108|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||1.108|-1.152|0.969
70940774|NCT05065918|141381658|SUPERIORITY||Slope|-0.5||||0.231|TWO_SIDED|95.0|-1.322|0.322|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||.322|-1.322|0.231
70940775|NCT05065918|141381659|SUPERIORITY||Slope|-0.319||||0.398|TWO_SIDED|95.0|-1.064|0.425|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||.425|-1.064|0.398
71075277|NCT03000530|141659483|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001|TWO_SIDED|95.0|-10.2|-3.9|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 15||-3.9|-10.2|< 0.0001
71075278|NCT03000530|141659483|SUPERIORITY||Least Squares Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|1.76||0.0064|TWO_SIDED|95.0|-8.4|-1.4|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 21||-1.4|-8.4|0.0064
71075279|NCT03000530|141659483|SUPERIORITY||Least Squares Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|1.77||0.0243|TWO_SIDED|95.0|-7.6|-0.5|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 28||-0.5|-7.6|0.0243
71075280|NCT03000530|141659483|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.86||0.2285|TWO_SIDED|95.0|-6.0|1.4|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 35||1.4|-6.0|0.2285
71075281|NCT03000530|141659483|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.86||0.212|TWO_SIDED|95.0|-6.0|1.4|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 42||1.4|-6.0|0.2120
71075282|NCT03000530|141659484|SUPERIORITY||Odds Ratio (OR)|4.4||||0.0884|TWO_SIDED|95.0|0.8|24.1|||Generalized Estimating Equation|Statistics are from a generalized estimating equation (GEE) method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 2||24.1|0.8|0.0884
71075283|NCT03000530|141659484|SUPERIORITY||Odds Ratio (OR)|2.4||||0.0732|TWO_SIDED|95.0|0.9|6.4|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 8||6.4|0.9|0.0732
71075284|NCT03000530|141659484|SUPERIORITY||Odds Ratio (OR)|9.6||||0.0002|TWO_SIDED|95.0|2.9|31.6|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 15||31.6|2.9|0.0002
71075285|NCT03000530|141659484|SUPERIORITY||Odds Ratio (OR)|6.7||||0.0006|TWO_SIDED|95.0|2.3|19.7|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 21||19.7|2.3|0.0006
71075286|NCT03000530|141659484|SUPERIORITY||Odds Ratio (OR)|3.1||||0.0379|TWO_SIDED|95.0|1.1|8.9|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 28||8.9|1.1|0.0379
71075287|NCT03000530|141659484|SUPERIORITY||Odds Ratio (OR)|3.0||||0.0468|TWO_SIDED|95.0|1.0|9.0|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 35||9.0|1.0|0.0468
71075288|NCT03000530|141659484|SUPERIORITY||Odds Ratio (OR)|1.9||||0.2208|TWO_SIDED|95.0|0.7|5.6|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 42||5.6|0.7|0.2208
71075289|NCT03000530|141659485|SUPERIORITY||Odds Ratio (OR)|1.5||||0.43|TWO_SIDED|95.0|0.6|3.7|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 8||3.7|0.6|0.4300
71116365|NCT01252186|141739275|SUPERIORITY_OR_OTHER||Treatment Difference|-5.99||||0.001|TWO_SIDED|95.0|-9.6|-2.4|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||-2.4|-9.6|0.001
71116366|NCT01252186|141739276|SUPERIORITY_OR_OTHER||Treatment Difference|0.33||||0.076|TWO_SIDED|95.0|0.0|0.7|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.7|-0.0|0.076
71075290|NCT03000530|141659485|SUPERIORITY||Odds Ratio (OR)|5.3||||0.0005|TWO_SIDED|95.0|2.1|13.3|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 15||13.3|2.1|0.0005
71075291|NCT03000530|141659485|SUPERIORITY||Odds Ratio (OR)|3.1||||0.0172|TWO_SIDED|95.0|1.2|8.0|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 21||8.0|1.2|0.0172
71075292|NCT03000530|141659485|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0221|TWO_SIDED|95.0|1.2|7.3|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 28||7.3|1.2|0.0221
71075293|NCT03000530|141659485|SUPERIORITY||Odds Ratio (OR)|1.4||||0.4139|TWO_SIDED|95.0|0.6|3.5|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 35||3.5|0.6|0.4139
71075294|NCT03000530|141659485|SUPERIORITY||Odds Ratio (OR)|1.7||||0.2332|TWO_SIDED|95.0|0.7|4.3|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 42||4.3|0.7|0.2332
71075295|NCT03000530|141659486|SUPERIORITY||Least Squares Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.38||0.0836|TWO_SIDED|95.0|-5.1|0.3|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 2||0.3|-5.1|0.0836
71075296|NCT03000530|141659486|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|2.32||0.0864|TWO_SIDED|95.0|-8.6|0.6|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 8||0.6|-8.6|0.0864
71075297|NCT03000530|141659486|SUPERIORITY||Least Squares Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|2.38||0.0021|TWO_SIDED|95.0|-12.3|-2.8|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 15||-2.8|-12.3|0.0021
71075298|NCT03000530|141659486|SUPERIORITY||Least Squares Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|2.69||0.0157|TWO_SIDED|95.0|-12.0|-1.3|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 21||-1.3|-12.0|0.0157
71075299|NCT03000530|141659486|SUPERIORITY||Least Squares Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|2.69||0.0533|TWO_SIDED|95.0|-10.6|0.1|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 28||0.1|-10.6|0.0533
71075300|NCT03000530|141659486|SUPERIORITY||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|2.87||0.2878|TWO_SIDED|95.0|-8.8|2.6|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 35||2.6|-8.8|0.2878
71075301|NCT03000530|141659486|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.7||0.4664|TWO_SIDED|95.0|-7.4|3.4|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 42||3.4|-7.4|0.4664
71075302|NCT03000530|141659489|SUPERIORITY||Least Squares Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.87||0.0391|TWO_SIDED|95.0|-3.6|-0.1|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable.||Day 2||-0.1|-3.6|0.0391
71075303|NCT03000530|141659489|SUPERIORITY||Least Squares Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|1.29||0.0516|TWO_SIDED|95.0|-5.1|0.0|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable.||Day 8||0.0|-5.1|0.0516
71075304|NCT03000530|141659489|SUPERIORITY||Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|1.32||0.0008|TWO_SIDED|95.0|-7.3|-2.0|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable.||Day 15||-2.0|-7.3|0.0008
71075305|NCT03000530|141659489|SUPERIORITY||Least Squares Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.54||0.0282|TWO_SIDED|95.0|-6.5|-0.4|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable.||Day 21||-0.4|-6.5|0.0282
71075306|NCT03000530|141659489|SUPERIORITY||Least Squares Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|1.56||0.1686|TWO_SIDED|95.0|-5.3|0.9|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable.||Day 28||0.9|-5.3|0.1686
71075307|NCT03000530|141659489|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.75||0.2488|TWO_SIDED|95.0|-5.5|1.5|||Mixed Effect Model for Repeated Measures|||Day 35||1.5|-5.5|0.2488
71116367|NCT01252186|141739276|SUPERIORITY_OR_OTHER||Treatment Difference|0.44||||0.021|TWO_SIDED|95.0|0.1|0.8|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.8|0.1|0.021
71116368|NCT01252186|141739277|SUPERIORITY_OR_OTHER||Treatment Difference|44.46||||0.19|TWO_SIDED|95.0|-22.3|111.2|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||111.2|-22.3|0.190
71075308|NCT03000530|141659489|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.76||0.2037|TWO_SIDED|95.0|-5.7|1.2|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable.||Day 42||1.2|-5.7|0.2037
71075309|NCT03000530|141659490|SUPERIORITY||Odds Ratio (OR)|5.5||||0.0048|TWO_SIDED|95.0|1.7|17.9|||Generalized Estimating Equation|Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 8||17.9|1.7|0.0048
71075310|NCT03000530|141659490|SUPERIORITY||Odds Ratio (OR)|8.6||||0.0007|TWO_SIDED|95.0|2.5|29.5|||Generalized Estimating Equation|Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 15||29.5|2.5|0.0007
71075311|NCT03000530|141659490|SUPERIORITY||Odds Ratio (OR)|4.4||||0.0113|TWO_SIDED|95.0|1.4|13.6|||Generalized Estimating Equation|Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 21||13.6|1.4|0.0113
71075312|NCT03000530|141659490|SUPERIORITY||Odds Ratio (OR)|3.9||||0.0227|TWO_SIDED|95.0|1.2|12.8|||Generalized Estimating Equation|Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 28||12.8|1.2|0.0227
71116369|NCT01252186|141739277|SUPERIORITY_OR_OTHER||Treatment Difference|9.74||||0.781|TWO_SIDED|95.0|-59.4|78.9|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||78.9|-59.4|0.781
71075313|NCT03000530|141659490|SUPERIORITY||Odds Ratio (OR)|2.3||||0.1516|TWO_SIDED|95.0|0.7|7.2|||Generalized Estimating Equation|Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 35||7.2|0.7|0.1516
71075314|NCT03000530|141659490|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0793|TWO_SIDED|95.0|0.9|8.3|||Generalized Estimating Equation|Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 42||8.3|0.9|0.0793
71075315|NCT03878875|141659499|SUPERIORITY|Multiple linear regressions analysed the effect of conditioning (group) on each outcome at the second time point - session 2 (after noise exposure), controlling for session 1 outcome (before noise exposure), event exposure, age, and gender. It was hypothesised those with high recent noise exposure, Group 1 (noise unit \> 0.323), would experience less temporary hearing damage than irregular attendees, Group 0.|F(5, 26)|116.044|||<|0.0005|TWO_SIDED||||||Regression, Linear|Group coefficient = -2.153.||||||< 0.0005
70940776|NCT05065918|141381660|SUPERIORITY||Slope|0.284||||0.382|TWO_SIDED|95.0|-0.356|0.924|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||.924|-.356|0.382
70853580|NCT04250077|141195271|SUPERIORITY||Median Difference (Net)|1.29230769|STANDARD_ERROR_OF_MEAN|0.81588207||0.06283641|TWO_SIDED|95.0|-0.3873203|2.97193574|||t-test, 1 sided|||||2.97193574|-0.3873203|0.06283641
71079431|NCT00482170|141666437|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.249|TWO_SIDED|95.0|0.84|2.0||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||2.00|0.84|0.249
70853581|NCT04250077|141195272|SUPERIORITY||proportion|0.11794871|STANDARD_ERROR_OF_MEAN|0.16796576||0.26422281|TWO_SIDED|95.0|-0.2233244|0.43508919|||Agresti Caffo proportion comparison|||||0.43508919|-0.2233244|0.26422281
70853582|NCT00412373|141195286|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.6||0.774||95.0|-2.7|3.7|||ANOVA|P-value based on the actual value and was from an ANOVA model with fixed effects for treatment, concomitant medication stratum, and country.|Paliperidone Extended Release (ER) - Placebo on the Actual Score.|||3.7|-2.7|0.774
70853583|NCT00412373|141195287|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|2.3|<|0.001||95.0|-13.8|-4.9|||ANCOVA|P-values are from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-4.9|-13.8|<0.001
70853584|NCT00412373|141195288|SUPERIORITY_OR_OTHER||LS Means Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.8|<|0.001||95.0|-4.4|-1.2|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-1.2|-4.4|<0.001
70853585|NCT00412373|141195289|SUPERIORITY_OR_OTHER||LS Means Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001||95.0|-3.1|-0.8|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-0.8|-3.1|<0.001
70853586|NCT00412373|141195290|SUPERIORITY_OR_OTHER||LS Means Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-6.8|-2.3|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-2.3|-6.8|<0.001
70853587|NCT00412373|141195291|SUPERIORITY_OR_OTHER||LS Means Difference|-2.7|STANDARD_ERROR_OF_MEAN|0.8|<|0.001||95.0|-4.2|-1.1|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-1.1|-4.2|<0.001
71079432|NCT00482170|141666438|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.18|||<|0.001|TWO_SIDED|95.0|1.48|3.21||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.21|1.48|<0.001
71079433|NCT00482170|141666438|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.42|||<|0.001|TWO_SIDED|95.0|1.62|3.62||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.62|1.62|<0.001
71079434|NCT00482170|141666438|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.35|||<|0.001|TWO_SIDED|95.0|1.58|3.51||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.51|1.58|<0.001
71079435|NCT00482170|141666438|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.42|||<|0.001|TWO_SIDED|95.0|1.64|3.59||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||3.59|1.64|<0.001
71079436|NCT00482170|141666439|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.34|||<|0.001|TWO_SIDED|95.0|1.5|3.65||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.65|1.50|<0.001
71079437|NCT00482170|141666439|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.96|||<|0.001|TWO_SIDED|95.0|1.83|4.77||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||4.77|1.83|<0.001
71079438|NCT00482170|141666439|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.58|||<|0.001|TWO_SIDED|95.0|1.62|4.12||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||4.12|1.62|<0.001
71075316|NCT03878875|141659500|SUPERIORITY|Multiple linear regressions analysed the effect of conditioning (group) on each outcome at the second time point - session 2 (after noise exposure), controlling for session 1 outcome (before noise exposure), event exposure, age, and gender. It was hypothesised those with high recent noise exposure, Group 1 (noise unit \> 0.323), would experience less temporary hearing damage than irregular attendees, Group 0.|F(5, 26)|12.839|||<|0.0005|TWO_SIDED||||||Regression, Linear|Group coefficient = 1.602.||||||< 0.0005
71075317|NCT03878875|141659501|SUPERIORITY|Multiple linear regressions analysed the effect of conditioning (group) on each outcome at the second time point - session 2 (after noise exposure), controlling for session 1 outcome (before noise exposure), event exposure, age, and gender. It was hypothesised those with high recent noise exposure, Group 1 (noise unit \> 0.323), would experience less temporary hearing damage than irregular attendees, Group 0.|F(5, 26)|8.391|||<|0.0005|TWO_SIDED||||||Regression, Linear|Group coefficient was 1.059.||||||< 0.0005
71075318|NCT03878875|141659502|SUPERIORITY|Multiple linear regressions analysed the effect of conditioning (group) on each outcome at the second time point - session 2 (after noise exposure), controlling for session 1 outcome (before noise exposure), event exposure, age, and gender. It was hypothesised those with high recent noise exposure, Group 1 (noise unit \> 0.323), would experience less temporary hearing damage than irregular attendees, Group 0.|F(5, 26)|6.416|||<|0.001|TWO_SIDED||||||Regression, Linear|Group coefficient was 0.635.||||||< 0.001
71075319|NCT03878875|141659503|SUPERIORITY|Multiple linear regressions analysed the effect of conditioning (group) on each outcome at the second time point - session 2 (after noise exposure), controlling for session 1 outcome (before noise exposure), event exposure, age, and gender. It was hypothesised those with high recent noise exposure, Group 1 (noise unit \> 0.323), would experience less temporary hearing damage than irregular attendees, Group 0.|F(5, 26)|5.805|||<|0.001|TWO_SIDED||||||Regression, Linear|Group coefficient was -0.383.||||||< 0.001
71075320|NCT03878875|141659504|SUPERIORITY|A binary logistic regression was employed to assess the effect of conditioning on tinnitus change (i.e. increasing or not) at session 2, adjusting for tinnitus reported at session 1, age, gender, and event exposure.|Odds Ratio (OR)|1.4|STANDARD_ERROR_OF_MEAN|0.14|<|0.005|TWO_SIDED|95.0|1.071|1.85|||Regression, Logistic|||||1.85|1.071|< 0.005
71075321|NCT00625404|141659537|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.59|1.52||||||Hazard ratio (HR) for HIV infection based on proportional hazards model, stratified on site. Study was designed to have 90% power to reject the null hypothesis that the HR for infection is \> 0.3||1.52|0.59|
71116370|NCT01252186|141739278|SUPERIORITY_OR_OTHER||Treatment Difference|-12.49||||0.843|TWO_SIDED|95.0|-136.4|111.4|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||111.4|-136.4|0.843
71116371|NCT01252186|141739278|SUPERIORITY_OR_OTHER||Treatment Difference|58.3||||0.376|TWO_SIDED|95.0|-71.3|187.9|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||187.9|-71.3|0.376
70853588|NCT00412373|141195292|SUPERIORITY_OR_OTHER||LS Means Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.6|<|0.001||95.0|-3.3|-0.9|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-0.9|-3.3|<0.001
70853589|NCT00412373|141195293|SUPERIORITY_OR_OTHER||LS Means Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.5|<|0.001||95.0|-2.9|-0.9|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-0.9|-2.9|<0.001
70853590|NCT00412373|141195294|SUPERIORITY_OR_OTHER||LS Means Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.5||0.001||95.0|-2.6|-0.6|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-0.6|-2.6|0.001
70853591|NCT00412373|141195295|SUPERIORITY_OR_OTHER||LS Means Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.016||95.0|-1.8|-0.2|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-0.2|-1.8|0.016
70853592|NCT00412373|141195297|SUPERIORITY_OR_OTHER||LS Means Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1||0.002||95.0|-0.7|-0.2|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-0.2|-0.7|0.002
70853593|NCT00412373|141195298|SUPERIORITY_OR_OTHER||LS Means Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2|<|0.001||95.0|-0.9|-0.3|||ANOVA|P-value is from an ANOVA model with fixed effects for treatment, concomitant medication stratum, and country.||||-0.3|-0.9|<0.001
71075322|NCT00625404|141659538|SUPERIORITY_OR_OTHER|||||||0.45|||||||Log Rank|||Log-rank test for difference in rate of grade 2 or higher creatinine, based on time to first event.||||0.45
71075323|NCT00625404|141659540|SUPERIORITY_OR_OTHER|||||||0.59|||||||Log Rank|||Log-rank test for difference in rates between groups||||0.59
71075324|NCT00625404|141659541|SUPERIORITY_OR_OTHER|||||||0.79|||||||Log Rank|||Log-rank test for difference in rates between groups||||0.79
71075325|NCT00625404|141659542|SUPERIORITY_OR_OTHER|||||||0.62|||||||Log Rank|||Log-rank test for difference in rates between groups||||0.62
71075326|NCT00625404|141659543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.89|||||||t-test, 2 sided|||t-test for difference on viral loads||||0.89
71075327|NCT00625404|141659544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.1||||0.82|||||||t-test, 2 sided|||t-test for difference in mean CD-4 counts||||0.82
71075328|NCT00625404|141659548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.73|||||||t-test, 2 sided|||t-test for difference in change in number of sexual partners over time||||0.73
71075329|NCT00306787|141659550|NON_INFERIORITY_OR_EQUIVALENCE|The estimated power for non-inferiority test (90%) was based on the non-inferiority margin of 1.0 day.|Median Difference (Final Values)|0.16|||||TWO_SIDED|95.0|-0.15|0.6|||Hodges-Lehman|||Difference in time to healing= time to healing for famciclovir- time to healing for valacyclovir.||0.60|-0.15|
70853594|NCT00412373|141195299|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel (CMH) chi-square test with modified ridit scores, stratified by concomitant medication stratum, and country.||||||0.046
70853595|NCT00412373|141195301|SUPERIORITY_OR_OTHER||LS Means Difference|-4.1|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-6.4|-1.7|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-1.7|-6.4|<0.001
70853596|NCT00412373|141195303|SUPERIORITY_OR_OTHER||LS Means Difference|-4.8|STANDARD_ERROR_OF_MEAN|1.5||0.001||95.0|-7.7|-2.0|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-2.0|-7.7|0.001
70853597|NCT02871882|141195304|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
71075330|NCT01887678|141659559|SUPERIORITY_OR_OTHER||Least Square|-6.37|STANDARD_ERROR_OF_MEAN|3.06||0.0383|TWO_SIDED|95.0|-12.4|-0.35|||ANCOVA||A negative value of the Least Square mean difference indicates a result in favor of Traumeel-Zeel.|||-0.35|-12.40|0.0383
71075331|NCT01887678|141659560|SUPERIORITY_OR_OTHER||Least Squares|-2.15||||0.3715|TWO_SIDED|95.0|-6.89|2.58|||ANCOVA|||Day 8±1||2.58|-6.89|0.3715
71075332|NCT01887678|141659560|SUPERIORITY_OR_OTHER||Least Square|-5.87||||0.0293|TWO_SIDED|95.0|-11.15|-0.6|||ANCOVA|||Day 15±1||-0.60|-11.15|0.0293
71075333|NCT01887678|141659560|SUPERIORITY_OR_OTHER||Least Squares|-5.24||||0.0686|TWO_SIDED|95.0|-10.88|0.4|||ANCOVA|||Day 29±3||0.40|-10.88|0.0686
71075334|NCT01887678|141659560|SUPERIORITY_OR_OTHER||Least Squares|-7.25||||0.015|TWO_SIDED|95.0|-13.08|-1.42|||ANCOVA|||Day 43±3||-1.42|-13.08|0.0150
70853598|NCT00913458|141195415|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.8|||<|0.0001|TWO_SIDED|95.0|2.7|12.5||The rate of sustained remission was analyzed using a logistic regression model with a 2-sided significance level of 5%.|Regression, Logistic|Values are based on a logistic regression model with treatment as the only factor.||The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||12.5|2.7|<0.0001
71075335|NCT01887678|141659560|SUPERIORITY_OR_OTHER||Least Squares|-7.56||||0.0134|TWO_SIDED|95.0|-13.54|-1.58|||ANCOVA|||Day 57±3||-1.58|-13.54|0.0134
71075336|NCT01887678|141659560|SUPERIORITY_OR_OTHER||Least Squares|-7.6||||0.0121|TWO_SIDED|95.0|-13.52|-1.68|||Least Squares|||Day 71±3||-1.68|-13.52|0.0121
71075337|NCT01887678|141659560|SUPERIORITY_OR_OTHER||Least Squares|-6.32||||0.0376|TWO_SIDED|95.0|-12.28|-0.37|||ANCOVA|||Day 85±3||-0.37|-12.28|0.0376
70853599|NCT00913458|141195415|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.61||||0.0085|TWO_SIDED|95.0|1.3|5.3||The rate of sustained remission was analyzed using a logistic regression model with a 2-sided significance level of 5%.|Regression, Logistic|Values are based on a logistic regression model with treatment as the only factor.||The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||5.3|1.3|0.0085
70853600|NCT00913458|141195415|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.22||||0.0397|TWO_SIDED|95.0|1.0|4.8||The rate of sustained remission was analyzed using a logistic regression model with a 2-sided significance level of 5%.|Regression, Linear|Values are based on a logistic regression model with treatment as the only factor.||The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.8|1.0|0.0397
70853601|NCT00913458|141195416|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~End of Phase 1"||||<0.0001
71075338|NCT01887678|141659561|SUPERIORITY_OR_OTHER||Least Squares|-4.76||||0.1373|TWO_SIDED|95.0|-11.05|1.53|||ANCOVA|||||1.53|-11.05|0.1373
71075339|NCT01887678|141659562|SUPERIORITY_OR_OTHER||Least Squares|-4.24||||0.1715|TWO_SIDED|95.0|-10.33|1.85|||ANCOVA|||||1.85|-10.33|0.1715
71075340|NCT01887678|141659563|SUPERIORITY_OR_OTHER||Least Squares|-4.77||||0.1211|TWO_SIDED|95.0|-10.82|1.27|||ANCOVA|||||1.27|-10.82|0.1211
71075341|NCT01887678|141659568|SUPERIORITY_OR_OTHER||Least Squares|-4.97||||0.1128|TWO_SIDED|95.0|-11.12|1.18|||ANCOVA|||Day 8±1||1.18|-11.12|0.1128
71075342|NCT01887678|141659568|SUPERIORITY_OR_OTHER||Least Squares|-10.49||||0.0013|TWO_SIDED|95.0|-16.85|-4.13|||ANCOVA|||Day 15±1||-4.13|-16.85|0.0013
71075343|NCT01887678|141659568|SUPERIORITY_OR_OTHER||Least Squares|-6.89||||0.0472|TWO_SIDED|95.0|-13.69|-0.09|||ANCOVA|||Day 29±3||-0.09|-13.69|0.0472
71075344|NCT01887678|141659568|SUPERIORITY_OR_OTHER||Least Squares|-8.82||||0.0109|TWO_SIDED|95.0|-15.6|-2.05|||ANCOVA|||Day 43±3||-2.05|-15.60|0.0109
71075345|NCT01887678|141659568|SUPERIORITY_OR_OTHER||Least Squares|-8.88||||0.0123|TWO_SIDED|95.0|-15.8|-1.95|||ANCOVA|||Day 57±3||-1.95|-15.80|0.0123
71075346|NCT01887678|141659568|SUPERIORITY_OR_OTHER||Least Squares|-6.88||||0.0425|TWO_SIDED|95.0|-13.52|-0.23|||ANCOVA|||Day 71±3||-0.23|-13.52|0.0425
71075347|NCT01887678|141659568|SUPERIORITY_OR_OTHER||Least Squares|-5.51||||0.1199|TWO_SIDED|95.0|-12.47|1.45|||ANCOVA|||Day 85±3||1.45|-12.47|0.1199
71075348|NCT01887678|141659568|SUPERIORITY_OR_OTHER||Least Squares|-4.96||||0.1575|TWO_SIDED|95.0|-11.86|1.93|||ANCOVA|||Day 119±3||1.93|-11.86|0.1575
71075349|NCT01887678|141659569|SUPERIORITY_OR_OTHER||Least Squares|-0.28||||0.6346|TWO_SIDED|95.0|-1.45|0.89|||ANCOVA|||Day 8±1||0.89|-1.45|0.6346
71075350|NCT01887678|141659569|SUPERIORITY_OR_OTHER||Least Squares|-0.28||||0.6458|TWO_SIDED|95.0|-1.49|0.92|||ANCOVA|||Day 15±1||0.92|-1.49|0.6458
71075351|NCT01887678|141659569|SUPERIORITY_OR_OTHER||Least Squares|-0.18||||0.7581|TWO_SIDED|95.0|-1.35|0.99|||ANCOVA|||Day 29±3||0.99|-1.35|0.7581
71075352|NCT01887678|141659569|SUPERIORITY_OR_OTHER||Least Squares|-0.49||||0.335|TWO_SIDED|95.0|-1.48|0.51|||ANCOVA|||Day 43±3||0.51|-1.48|0.3350
71075353|NCT01887678|141659569|SUPERIORITY_OR_OTHER||Least Squares|-0.4||||0.4419|TWO_SIDED|95.0|-1.44|0.63|||ANCOVA|||Day 57±3||0.63|-1.44|0.4419
71075354|NCT01887678|141659569|SUPERIORITY_OR_OTHER||Least Squares|-0.37||||0.446|TWO_SIDED|95.0|-1.32|0.58|||ANCOVA|||Day 71±3||0.58|-1.32|0.4460
71075355|NCT01887678|141659569|SUPERIORITY_OR_OTHER||Least Squares|0.25||||0.6552|TWO_SIDED|95.0|-0.84|1.33|||ANCOVA|||Day 85±3||1.33|-0.84|0.6552
71075356|NCT01887678|141659569|SUPERIORITY_OR_OTHER||Least Squares|-0.19||||0.7443|TWO_SIDED|95.0|-1.33|0.95|||ANCOVA|||Day 119±3||0.95|-1.33|0.7443
71075357|NCT01887678|141659574|SUPERIORITY_OR_OTHER|||||||0.2164|TWO_SIDED||||||Log Rank|Results of Kaplan-Meier Analysis with p-value from 2-sided log-rank test for equality of survival functions||After first injection of study drug||||0.2164
71075358|NCT01887678|141659574|SUPERIORITY_OR_OTHER|||||||0.1651|TWO_SIDED|||||Results of Kaplan-Meier Analysis with p-value from 2-sided log-rank test for equality of survival functions|Log Rank|||After second injection of study drug||||0.1651
71075359|NCT01887678|141659574|SUPERIORITY_OR_OTHER|||||||0.222|TWO_SIDED||||||Log Rank|Results of Kaplan-Meier Analysis with p-value from 2-sided log-rank test for equality of survival functions||After third injection of study drug||||0.2220
71075360|NCT01887678|141659575|SUPERIORITY_OR_OTHER|||||||0.0264|TWO_SIDED||||||Log Rank|For equality of survival functions||After first injection of study drug||||0.0264
71075361|NCT01887678|141659575|SUPERIORITY_OR_OTHER|||||||0.0346|TWO_SIDED||||||Log Rank|For equality of survival functions||After second injection of study drug||||0.0346
71075362|NCT01887678|141659575|SUPERIORITY_OR_OTHER|||||||0.0172|TWO_SIDED||||||Log Rank|For equality of survival functions||After third injection of study drug||||0.0172
71075363|NCT00678470|141659647|OTHER||Correlation|1.0||||0.0003|TWO_SIDED||||||Fisher Exact||||Using Fisher's non-parametric test of associations, correlations were determined between the patients who were intralesional responders with their response at ‡70% change in PASI score.|||0.0003
71075364|NCT00586508|141659692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3375||||||P-value is for Physical Well-Being Cycle 1.|ANCOVA|P-value of treatment effect from an Analysis of Covariance (ANCOVA) for change from baseline. Covariates include: treatment and baseline value.||||||0.3375
71075365|NCT00586508|141659692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.516||||||P-value is for Physical Well-Being Cycle 2.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.516
71075366|NCT00586508|141659692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.786||||||P-value is for Physical Well-Being Cycle 3.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.786
71075367|NCT00586508|141659692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1496||||||P-value is for Physical Well-Being Cycle 4.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.1496
71116372|NCT01252186|141739279|SUPERIORITY_OR_OTHER||Treatment Difference|-4.01||||0.731|TWO_SIDED|95.0|-27.0|19.0|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||19.0|-27.0|0.731
71075368|NCT00586508|141659692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8428||||||P-value is for Physical Well-Being Cycle 5.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.8428
71075369|NCT00586508|141659692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7345||||||P-value is for Physical Well-Being Cycle 6.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.7345
71075370|NCT00586508|141659692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8928||||||P-value is for Physical Well-Being Cycle 7.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.8928
71075371|NCT00586508|141659692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7343||||||P-value is for Physical Well-Being Cycle 8.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.7343
71075372|NCT00586508|141659692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8798||||||P-value is for Social/Family Well-Being Cycle 1.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.8798
71075373|NCT00586508|141659692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6837||||||P-value is for Social/Family Well-Being Cycle 2.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.6837
71075374|NCT00586508|141659692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7226||||||P-value is for Social/Family Well-Being Cycle 3.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.7226
71075375|NCT00586508|141659692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.641||||||P-value is for Social/Family Well-Being Cycle 4.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.641
71075376|NCT00586508|141659692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.478||||||P-value is for Social/Family Well-Being Cycle 5.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.478
71075377|NCT00586508|141659692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9367||||||P-value is for Social/Family Well-Being Cycle 6.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.9367
71075378|NCT00586508|141659692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5108||||||P-value is for Social/Family Well-Being Cycle 7.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.5108
71075379|NCT00586508|141659692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8976||||||P-value is for Social/Family Well-Being Cycle 8.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.8976
71075380|NCT00586508|141659692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8193||||||P-value is for Emotional Well-Being Cycle 1.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.8193
71075381|NCT00586508|141659692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1695||||||P-value is for Emotional Well-Being Cycle 2.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.1695
71075382|NCT00586508|141659692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4021||||||P-value is for Emotional Well-Being Cycle 3.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.4021
71075383|NCT00586508|141659692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3603||||||P-value is for Emotional Well-Being Cycle 4.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.3603
71075384|NCT00586508|141659692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5169||||||P-value is for Emotional Well-Being Cycle 5.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.5169
71075385|NCT00586508|141659692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1642||||||P-value is for Emotional Well-Being Cycle 6.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.1642
71116373|NCT01252186|141739279|SUPERIORITY_OR_OTHER||Treatment Difference|130.15|||<|0.001|TWO_SIDED|95.0|106.2|154.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||154.1|106.2|<0.001
71116374|NCT04283994|141739292|SUPERIORITY||Risk Difference (RD)|0.114||||0.023|TWO_SIDED|95.0|0.03|0.197||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital site and dementia diagnosis. Confidence intervals using robust standard errors.|A total sample size of 600 (200 per arm) would give 80% power to detect a difference in proportions of 0.16 for each of the 3 pairwise comparisons assuming an overall 0.5 significance threshold, a Bonferroni adjustment for the 3 comparisons, and variance based on a proportion of 0.54.||0.197|0.030|0.023
71117721|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-62.49|||<|0.001|TWO_SIDED|95.0|-78.64|-46.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-46.34|-78.64|<0.001
71075386|NCT00586508|141659692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6354||||||P-value is for Emotional Well-Being Cycle 7.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.6354
71075387|NCT00586508|141659692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3517||||||P-value is for Emotional Well-Being Cycle 8.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.3517
70853602|NCT00913458|141195417|SUPERIORITY_OR_OTHER|||||||0.1183|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 52"||||0.1183
70853603|NCT00913458|141195417|SUPERIORITY_OR_OTHER|||||||0.0286|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Final on therapy"||||0.0286
70853604|NCT00913458|141195418|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 13, 26, 39, 52 and final on therapy"||||<0.0001
70853605|NCT00913458|141195419|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 13, 26, 39, 52 and final on therapy"||||<0.0001
71075388|NCT00586508|141659692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7605||||||P-value is for Functional Well-Being Cycle 1.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.7605
71075389|NCT00586508|141659692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3747||||||P-value is for Functional Well-Being Cycle 2.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.3747
71116375|NCT04283994|141739292|SUPERIORITY||Risk Difference (RD)|0.068||||0.294|TWO_SIDED|95.0|-0.013|0.15||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bidirectional intervention - usual care. Estimated via linear regression after adjusting for hospital site and dementia diagnosis. Confidence intervals using robust standard errors.|A total sample size of 600 (200 per arm) would give 80% power to detect a difference in proportions of 0.16 for each of the 3 pairwise comparisons assuming an overall 0.5 significance threshold, a Bonferroni adjustment for the 3 comparisons, and variance based on a proportion of 0.54.||0.150|-0.013|0.294
71116376|NCT04283994|141739292|SUPERIORITY||Risk Difference (RD)|-0.045||||0.952|TWO_SIDED|95.0|-0.134|0.044||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bidirectional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital site and dementia diagnosis. Confidence intervals using robust standard errors.|A total sample size of 600 (200 per arm) would give 80% power to detect a difference in proportions of 0.16 for each of the 3 pairwise comparisons assuming an overall 0.5 significance threshold, a Bonferroni adjustment for the 3 comparisons, and variance based on a proportion of 0.54.||0.044|-0.134|0.952
70853606|NCT00913458|141195420|SUPERIORITY_OR_OTHER|||||||0.0063|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 13"||||0.0063
70853607|NCT00913458|141195420|SUPERIORITY_OR_OTHER|||||||0.0053|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 26"||||0.0053
71075390|NCT00586508|141659692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8379||||||P-value is for Functional Well-Being Cycle 3.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.8379
71075391|NCT00586508|141659692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1179||||||P-value is for Functional Well-Being Cycle 4.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.1179
71075392|NCT00586508|141659692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7412||||||P-value is for Functional Well-Being Cycle 5.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.7412
71075393|NCT00586508|141659692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3773||||||P-value is for Functional Well-Being Cycle 6.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.3773
71075394|NCT00586508|141659692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7402||||||P-value is for Functional Well-Being Cycle 7.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.7402
71075395|NCT00586508|141659692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2671||||||P-value is for Functional Well-Being Cycle 8.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.2671
71075396|NCT00432276|141659726|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted at the 1-sided 0.025 significance level. Non-inferiority was demonstrated if the upper confidence limit for the LS mean difference was less than +0.3%.|LS mean difference|-0.47|||||ONE_SIDED|97.5||-0.35|||ANCOVA||Least squares means are from an ANCOVA model with treatment, study schedule, and geographic region as class variables, and baseline metformin dose and baseline HbA1c as covariates.|The analysis was conducted at the 1-sided 0.025 significance level. Non-inferiority was demonstrated if the upper confidence limit for the LS mean difference was less than +0.3%.||-0.35||
71075397|NCT00432276|141659726|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted at the 1-sided 0.025 significance level. Non-inferiority was demonstrated if the upper confidence limit for the LS mean difference was less than +0.3%.|LS mean difference|-0.42|||||ONE_SIDED|97.5||-0.28|||ANCOVA||Least squares means are from an ANCOVA model with treatment, study schedule, and geographic region as class variables, and baseline metformin dose and baseline HbA1c as covariates.|Comparison of Change from Baseline at Week 52. The null hypothesis was that the average change from Baseline in HbA1c at Week 52 for the alogliptin 25 mg addition group is inferior to the average change for the pioglitazone titration group. The alternative hypothesis was that the change from Baseline in HbA1c for the alogliptin 25 mg addition group was non-inferior to the change for the pioglitazone titration group for at Week 52.||-0.28||
71075398|NCT00432276|141659727|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.44|||<|0.001|TWO_SIDED|95.0|-0.57|-0.31||Statistical tests and resulting P-values are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|ANCOVA model with treatment, study schedule, and geographic region as class variables, and baseline metformin dose and baseline HbA1c as covariates.||Comparison of change from Baseline in HbA1c at Week 42.||-0.31|-0.57|<0.001
71075399|NCT00432276|141659735|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.9|||<|0.001|TWO_SIDED|95.0|-16.2|-5.7||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and FPG as covariates.||Comparison of change from Baseline at Week 52.||-5.7|-16.2|<0.001
71116377|NCT04283994|141739299|SUPERIORITY||Mean Difference (Final Values)|-0.3||||1.65|TWO_SIDED|95.0|-1.3|0.7||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.7|-1.3|1.650
71116378|NCT04283994|141739299|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.985|TWO_SIDED|95.0|-1.6|0.5||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.5|-1.6|0.985
71075400|NCT00432276|141659736|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|Extended Mantel Haenszel Test|Treatment comparison was performed using nonparametric, covariance-adjusted, extended Mantel-Haenszel test.||Comparison of incidence of marked hyperglycemia through Week 52.||||<0.001
70853608|NCT00913458|141195420|SUPERIORITY_OR_OTHER|||||||0.0027|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 39"||||0.0027
71075401|NCT00432276|141659737|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|Extended Mantel Haenszel Test|Treatment comparison was performed using nonparametric, covariance-adjusted, extended Mantel-Haenszel test.||Comparison of incidence of hyperglycemic rescue through Week 52.||||<0.001
71075402|NCT00432276|141659738|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6||||0.116|TWO_SIDED|95.0|-3.7|0.4||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and proinsulin as covariates.||Comparison of change from Baseline at Week 52.||0.4|-3.7|0.116
71075403|NCT00432276|141659739|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73||||0.276|TWO_SIDED|95.0|-0.58|2.04||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and fasting insulin as covariates.||Comparison of change from Baseline at Week 52.||2.04|-0.58|0.276
71075404|NCT00432276|141659740|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.041|||<|0.001|TWO_SIDED|95.0|-0.063|-0.018||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as covariates.||Comparison of change from Baseline at Week 52.||-0.018|-0.063|<0.001
71075405|NCT00432276|141659741|SUPERIORITY_OR_OTHER||LS Mean Difference|0.073||||0.23|TWO_SIDED|95.0|-0.047|0.193||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline fasting C-peptide as covariates.||Comparison of change from Baseline at Week 52.||0.193|-0.047|0.230
71075406|NCT00432276|141659742|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.188||||0.567|TWO_SIDED|95.0|-0.83|0.455||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HOMA insulin resistance as covariates.||Comparison of change from Baseline at Week 52.||0.455|-0.830|0.567
71075407|NCT00432276|141659743|SUPERIORITY_OR_OTHER||LS Mean Difference|12.963|||<|0.001|TWO_SIDED|95.0|5.333|20.592||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as covariates.||Comparison of change from Baseline at Week 52.||20.592|5.333|<0.001
71075408|NCT00432276|141659744|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.071|TWO_SIDED|95.0|-1.03|0.04||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline body weight as covariates.||Comparison of change from Baseline at Week 52.||0.04|-1.03|0.071
71075409|NCT00432276|141659745|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.2||||0.058|TWO_SIDED|95.0|-8.6|0.1||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as covariates.||Comparison of change from Baseline at Week 52.||0.1|-8.6|0.058
71075410|NCT00432276|141659746|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.228|TWO_SIDED|95.0|-1.7|0.4||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as covariates.||Comparison of change from Baseline at Week 52.||0.4|-1.7|0.228
71075411|NCT00432276|141659747|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8||||0.132|TWO_SIDED|95.0|-6.5|0.9||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as covariates.||Comparison of change from Baseline at Week 52.||0.9|-6.5|0.132
71075412|NCT00432276|141659748|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.6||||0.08|TWO_SIDED|95.0|-18.3|1.0||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline triglycerides as covariates.||Comparison of change from Baseline at Week 52.||1.0|-18.3|0.080
71075413|NCT00432276|141659749|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0314||||0.059|TWO_SIDED|95.0|-0.064|0.0012||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline free fatty acid as covariates.||Comparison of change from Baseline at Week 52.||0.0012|-0.0640|0.059
70853609|NCT00913458|141195420|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 52"||||0.0002
70853610|NCT00913458|141195420|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Final on therapy"||||0.0005
71079439|NCT00482170|141666439|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.45|||<|0.001|TWO_SIDED|95.0|1.55|3.86||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||3.86|1.55|<0.001
70853611|NCT00913458|141195421|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 13, 26, 39, 52 and final on therapy"||||<0.0001
71116379|NCT04283994|141739299|SUPERIORITY||Mean Difference (Final Values)|0.2||||2.155|TWO_SIDED|95.0|-1.0|1.4||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||1.4|-1.0|2.155
71116380|NCT04283994|141739300|SUPERIORITY||Mean Difference (Final Values)|0.7||||2.169|TWO_SIDED|95.0|-3.1|4.4||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis,|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||4.4|-3.1|2.169
71116381|NCT04283994|141739300|SUPERIORITY||Mean Difference (Final Values)|-3.3||||0.391|TWO_SIDED|95.0|-7.5|1.0||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||1.0|-7.5|0.391
71116382|NCT04283994|141739300|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.21|TWO_SIDED|95.0|-0.3|8.2||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||8.2|-0.3|0.210
71116383|NCT04283994|141739301|SUPERIORITY||Mean Difference (Final Values)|0.8||||1.01|TWO_SIDED|95.0|-0.8|2.4||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||2.4|-0.8|1.010
71116384|NCT04283994|141739301|SUPERIORITY||Mean Difference (Final Values)|0.0||||2.923|TWO_SIDED|95.0|-1.7|1.7||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||1.7|-1.7|2.923
71116385|NCT04283994|141739301|SUPERIORITY||Mean Difference (Final Values)|0.8||||1.034|TWO_SIDED|95.0|-0.9|2.5||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||2.5|-0.9|1.034
71116386|NCT04283994|141739302|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.384|TWO_SIDED|95.0|-1.0|7.9||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||7.9|-1.0|0.384
71116387|NCT04283994|141739302|SUPERIORITY||Mean Difference (Final Values)|-1.2||||1.923|TWO_SIDED|95.0|-6.1|3.7||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||3.7|-6.1|1.923
71116388|NCT04283994|141739302|SUPERIORITY||Mean Difference (Final Values)|4.6||||0.166|TWO_SIDED|95.0|-0.1|9.4||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||9.4|-0.1|0.166
71116389|NCT04283994|141739303|SUPERIORITY||Risk Difference (RD)|-0.11||||0.16|TWO_SIDED|95.0|-0.23|0.0||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.00|-0.23|0.160
71116390|NCT04283994|141739303|SUPERIORITY||Risk Difference (RD)|-0.07||||0.652|TWO_SIDED|95.0|-0.18|0.04||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.04|-0.18|0.652
70853612|NCT00913458|141195422|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"||||<0.0001
70853613|NCT00913458|141195423|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 week and final on therapy"||||<0.0001
71075414|NCT00432276|141659750|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.934|TWO_SIDED|95.0|-2.9|2.6||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as covariates.||Comparison of change from Baseline at Week 52.||2.6|-2.9|0.934
71075415|NCT00432276|141659751|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.07|TWO_SIDED|95.0|-1.3|0.1||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as covariates.||Comparison of change from Baseline at Week 52.||0.1|-1.3|0.070
71075416|NCT00432276|141659752|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.9||||0.064|TWO_SIDED|95.0|-5.9|0.2||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as covariates.||Comparison of change from Baseline at Week 52.||0.2|-5.9|0.064
71075417|NCT00432276|141659753|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.022|TWO_SIDED|95.0|-1.0|-0.1||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as covariates.||Comparison of change from Baseline at Week 52.||-0.1|-1.0|0.022
71075418|NCT00432276|141659754|SUPERIORITY_OR_OTHER||LS Mean Difference|1.78||||0.308|TWO_SIDED|95.0|-1.65|5.22||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as covariates.||Comparison of change from Baseline at Week 52.||5.22|-1.65|0.308
71075419|NCT00432276|141659755|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8209||||0.283|TWO_SIDED|95.0|-2.3209|0.679||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline hsCRP as covariates.||Comparison of change from Baseline at Week 52.||0.6790|-2.3209|0.283
71075420|NCT00432276|141659756|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.92|||<|0.001|TWO_SIDED|95.0|-4.57|-1.27||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline adiponectin as covariates.||Comparison of change from Baseline at Week 52.||-1.27|-4.57|<0.001
71075421|NCT00432276|141659757|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.1||||0.197|TWO_SIDED|95.0|-15.4|3.2||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|||Comparison of change from Baseline at Week 52.||3.2|-15.4|0.197
71075422|NCT03646305|141659786|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental,control) × 2(Activity: singing,verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, believability of thought were equivalent across time||||<0.001
71075423|NCT03646305|141659786|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure differences in believability of thought from baseline to post-intervention. Null hypothesis: there would be no significant difference in believability of thought from baseline to post-intervention||||<0.001
71075424|NCT03646305|141659786|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure differences from post-intervention to follow-up. Null hypothesis: there would be no significant differences in believability of thought from post-intervention to follow-up.||||<0.001
71075425|NCT03646305|141659786|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal believability scores||||>0.05
71075426|NCT03646305|141659786|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal believability scores||||>0.05
70940777|NCT05065918|141381661|SUPERIORITY||Slope|0.382||||0.266|TWO_SIDED|95.0|-0.284|1.025|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||1.025|-.284|0.266
70940778|NCT05065918|141381662|SUPERIORITY||Slope|0.53||||0.019|TWO_SIDED|95.0|0.089|0.97|||Regression, Linear|||||.970|0.089|0.019
70940779|NCT05065918|141381663|SUPERIORITY||Slope|0.277||||0.284|TWO_SIDED|95.0|-0.232|0.787|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||0.787|-.232|0.284
70940780|NCT05065918|141381664|SUPERIORITY||Slope|0.709||||0.076|TWO_SIDED|95.0|-0.076|1.494|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||1.494|-.076|0.076
70940781|NCT05065918|141381665|SUPERIORITY||Slope|0.625||||0.136|TWO_SIDED|95.0|-0.199|1.449|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||1.449|-.199|0.136
70940782|NCT01090076|141381666|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||t-test, 2 sided|||||||0.023
70940783|NCT01090076|141381667|SUPERIORITY_OR_OTHER|||||||0.877||95.0|||||t-test, 2 sided|||||||0.877
70940784|NCT01090076|141381668|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||t-test, 2 sided|||||||0.44
70940785|NCT00113880|141381670|SUPERIORITY_OR_OTHER|||||||0.01||||||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Exact method or Cox model|||Breast lump/cyst event rates were presented per 1,000 person-months. If the control group has no event, the relative risk (RR) or hazard ratio (HR) is not estimable.||||0.01
70940786|NCT00113880|141381670|SUPERIORITY_OR_OTHER|||||||0.01||||||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Exact method or Cox model|||Breast lump/cyst event rates were presented per 1,000 person-months. If the control group has no event, the RR or HR is not estimable.||||0.01
71075427|NCT03646305|141659786|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in believability scores||||>0.05
71075428|NCT03646305|141659786|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions have equivalent believability scores across time.||||>0.05
70940787|NCT00113880|141381670|SUPERIORITY_OR_OTHER|||||||0.02||||||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Exact method or Cox model|||Breast lump/cyst event rates were presented per 1,000 person-months. If the control group has no event, the RR or HR is not estimable.||||0.02
70940788|NCT00113880|141381670|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.59||||0.02|TWO_SIDED|95.0|0.64|3.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Mastitis event rates were presented per 1,000 person-months.||3.92|0.64|0.02
70940789|NCT00113880|141381670|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|7.35||||0.01|TWO_SIDED|95.0|2.2|24.54||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Mastitis event rates were presented per 1,000 person-months.||24.54|2.20|0.01
70940790|NCT00113880|141381670|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|7.17||||0.01|TWO_SIDED|95.0|2.13|24.13||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Mastitis event rates were presented per 1,000 person-months.||24.13|2.13|0.01
70940791|NCT00113880|141381671|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.05||||0.03|TWO_SIDED|95.0|0.0|0.79||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Heart murmur event rates were presented per 1,000 person-months.||0.79|0.00|0.03
70940792|NCT00113880|141381671|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.13||||0.05|TWO_SIDED|95.0|0.02|1.0||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox|||Heart murmur event rates were presented per 1,000 person-months.||1.00|0.02|0.05
71075429|NCT03646305|141659786|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on believability scores||||>0.05
71075430|NCT03646305|141659786|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no significant difference between 4 conditions on believability||||>0.05
71075431|NCT03646305|141659787|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, appraisal of target thought were equivalent across time.||||<0.001
71075432|NCT03646305|141659787|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||=|0.005|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent across time.||||=0.005
71075433|NCT03646305|141659787|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||=|0.002|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in negativity from baseline to post-intervention. Null hypothesis: the control conditions would have no significant difference in negativity from baseline to post-intervention||||=0.002
71075434|NCT03646305|141659787|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in negativity from post-intervention to follow-up. Null hypothesis: the control conditions would have no significant difference in negativity from post-intervention to follow-up.||||<0.001
71075435|NCT03646305|141659787|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.025|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure differences in negativity from baseline to post-intervention. Null hypothesis: there would be no significant difference in negativity scores from baseline to post-intervention in the experimental conditions||||>0.025
71075436|NCT03646305|141659787|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.025|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in negativity from post-intervention to follow-up. Null hypothesis: the experimental conditions would have no significant difference in negativity scores from post-intervention to follow-up.||||>0.025
71075437|NCT03646305|141659787|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal negativity scores||||>0.05
71075438|NCT03646305|141659787|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal negativity scores||||>0.05
71116391|NCT04283994|141739303|SUPERIORITY||Risk Difference (RD)|-0.04||||1.39|TWO_SIDED|95.0|-0.16|0.07||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.07|-0.16|1.390
71075439|NCT03646305|141659787|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in negativity scores||||>0.05
71075440|NCT03646305|141659787|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on negativity scores||||>0.05
71116392|NCT04283994|141739304|SUPERIORITY||Risk Difference (RD)|0.05||||1.192|TWO_SIDED|95.0|-0.06|0.16||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.16|-0.06|1.192
71116393|NCT04283994|141739304|SUPERIORITY||Risk Difference (RD)|0.01||||2.698|TWO_SIDED|95.0|-0.11|0.12||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.12|-0.11|2.698
71116394|NCT04283994|141739304|SUPERIORITY||Risk Difference (RD)|0.04||||1.477|TWO_SIDED|95.0|-0.08|0.16||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.16|-0.08|1.477
71078816|NCT01796301|141665660|SUPERIORITY||Treatment difference|4.4|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|3.4|5.4|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.||5.4|3.4|< 0.0001
71078817|NCT00264290|141665669|OTHER|||||||0.007|||||||Fisher Exact|||||||0.007
71116395|NCT04283994|141739305|SUPERIORITY||Mean Difference (Final Values)|-0.57||||2.293|TWO_SIDED|95.0|-4.3|3.16||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||3.16|-4.30|2.293
70940793|NCT00113880|141381671|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.11||||0.04|TWO_SIDED|95.0|0.01|0.86||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Heart murmur event rates were presented per 1,000 person-months.||0.86|0.01|0.04
71075441|NCT03646305|141659787|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between four conditions on negativity scores||||>0.05
71075442|NCT03646305|141659788|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at p\< .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, levels of discomfort were equivalent across time.||||<0.001
71075443|NCT03646305|141659788|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in levels of discomfort from baseline to post-intervention. Null hypothesis: there would have no significant differences in discomfort levels from baseline to post-intervention across samples||||<0.001
71079440|NCT00482170|141666440|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.681|TWO_SIDED|95.0|0.73|1.62||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.62|0.73|0.681
71079441|NCT00482170|141666440|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.947|TWO_SIDED|95.0|0.67|1.54||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.54|0.67|0.947
71079442|NCT00482170|141666440|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.604|TWO_SIDED|95.0|0.59|1.36||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.36|0.59|0.604
70940794|NCT00113880|141381671|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.37||||0.01|TWO_SIDED|95.0|0.2|0.7||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population was the 18-49 year age group.|Pregnancy exam/supervision event rates were presented per 1,000 person-months.||0.70|0.20|0.01
71079443|NCT00482170|141666440|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.43|TWO_SIDED|95.0|0.57|1.27||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.27|0.57|0.430
71079444|NCT00482170|141666441|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.072|TWO_SIDED|95.0|0.48|1.03||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.03|0.48|0.072
71079445|NCT00482170|141666441|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.205|TWO_SIDED|95.0|0.86|2.03||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.03|0.86|0.205
71079446|NCT00482170|141666441|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.434|TWO_SIDED|95.0|0.78|1.78||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.78|0.78|0.434
71079447|NCT00482170|141666441|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.857|TWO_SIDED|95.0|0.69|1.55||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.55|0.69|0.857
71075444|NCT03646305|141659788|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in levels of discomfort from post-intervention to follow-up. Null hypothesis: there would be no significant differences in discomfort levels from post-intervention to follow-up across samples||||<0.001
71075445|NCT03646305|141659788|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of discomfort||||>0.05
71116396|NCT04283994|141739305|SUPERIORITY||Mean Difference (Final Values)|-0.48||||2.381|TWO_SIDED|95.0|-4.11|3.14||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||3.14|-4.11|2.381
71116397|NCT04283994|141739305|SUPERIORITY||Mean Difference (Final Values)|-0.09||||2.893|TWO_SIDED|95.0|-3.86|3.69||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||3.69|-3.86|2.893
71116398|NCT04283994|141739306|SUPERIORITY||Risk Difference (RD)|0.0||||2.829|TWO_SIDED|95.0|-0.13|0.12||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.12|-0.13|2.829
71116399|NCT04283994|141739306|SUPERIORITY||Risk Difference (RD)|0.11||||0.188|TWO_SIDED|95.0|-0.01|0.24||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.24|-0.01|0.188
71116400|NCT04283994|141739306|SUPERIORITY||Risk Difference (RD)|-0.12||||0.19|TWO_SIDED|95.0|-0.24|0.01||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.01|-0.24|0.190
71116401|NCT04283994|141739307|SUPERIORITY||Risk Difference (RD)|0.03||||1.994|TWO_SIDED|95.0|-0.09|0.14||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.14|-0.09|1.994
71116402|NCT04283994|141739307|SUPERIORITY||Risk Difference (RD)|0.07||||0.771|TWO_SIDED|95.0|-0.05|0.19||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.19|-0.05|0.771
71116403|NCT04283994|141739307|SUPERIORITY||Risk Difference (RD)|-0.04||||1.447|TWO_SIDED|95.0|-0.17|0.08||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.08|-0.17|1.447
71116404|NCT04283994|141739310|SUPERIORITY||Risk Difference (RD)|-0.012||||1.836|TWO_SIDED|95.0|-0.058|0.034||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.034|-0.058|1.836
71116405|NCT04283994|141739310|SUPERIORITY||Risk Difference (RD)|0.021||||1.25|TWO_SIDED|95.0|-0.03|0.073||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.073|-0.030|1.250
70853614|NCT00913458|141195424|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"||||<0.0001
71075446|NCT03646305|141659788|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal levels of discomfort||||>0.05
71075447|NCT03646305|141659788|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in levels of discomfort||||>0.05
71075448|NCT03646305|141659788|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in levels of discomfort across time||||>0.05
71075449|NCT03646305|141659788|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of discomfort||||>0.05
71075450|NCT03646305|141659788|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no significant difference between 4 conditions on discomfort levels||||>0.05
71075451|NCT03646305|141659789|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, willingness to engage with target thought were equivalent across time||||<0.001
71116406|NCT04283994|141739310|SUPERIORITY||Risk Difference (RD)|-0.033||||0.581|TWO_SIDED|95.0|-0.084|0.017||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.017|-0.084|0.581
70853615|NCT00913458|141195425|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"||||<0.0001
70853616|NCT00913458|141195426|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 2, 4, 8, 13, 26, 39, 52 week and final on therapy"||||<0.0001
70853617|NCT00913458|141195427|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"||||<0.0001
70940795|NCT00113880|141381671|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||0.01|TWO_SIDED|95.0|0.22|0.74||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population was the all ages combined group.|Pregnancy exam/supervision event rates were presented per 1,000 person-months.||0.74|0.22|0.01
70940796|NCT00113880|141381671|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.05||||0.01|TWO_SIDED|95.0|0.03|0.08||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population was the 18-49 year age and the all ages combined groups.|Pregnancy exam/supervision event rates were presented per 1,000 person-months.||0.08|0.03|0.01
70940797|NCT00113880|141381671|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.02||||0.01|TWO_SIDED|95.0|0.01|0.03|||Regression, Cox||Population was the 18-49 year age and all ages combined groups.|Pregnancy exam/supervision event rates were presented per 1,000 person-months.||0.03|0.01|0.01
71075452|NCT03646305|141659789|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in willingness to engage with target thought from baseline to post-intervention. Null hypothesis: there would be no difference in willingness scores from baseline to post-intervention||||<0.001
71075453|NCT03646305|141659789|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||=|0.053|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in willingness to engage with target thought from post-intervention to follow-up. Null hypothesis: there would be no significant difference in willingness scores from post-intervention to follow-up.||||=0.053
71116407|NCT04283994|141739311|SUPERIORITY||Risk Difference (RD)|-0.039||||0.692|TWO_SIDED|95.0|-0.102|0.025||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.025|-0.102|0.692
71116408|NCT04283994|141739311|SUPERIORITY||Risk Difference (RD)|0.038||||0.887|TWO_SIDED|95.0|-0.033|0.109||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.109|-0.033|0.887
71116409|NCT04283994|141739311|SUPERIORITY||Risk Difference (RD)|-0.077||||0.08|TWO_SIDED|95.0|-0.145|-0.009||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||-0.009|-0.145|0.080
71116410|NCT04283994|141739312|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.293|TWO_SIDED|95.0|0.9|2.1||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Cox|Wald test adjusting for hospital site and dementia diagnosis.|Hazard ratio = bi-directional intervention / usual care. Estimated via cox proportional hazards regression after adjusting for hospital and dementia diagnosis. Exponentiated Wald confidence intervals.|Censoring by death.||2.1|0.9|0.293
70940798|NCT00113880|141381672|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.06||||0.04|TWO_SIDED|95.0|1.02|4.13||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Urticaria event rates were presented per 1,000 person-months.||4.13|1.02|0.04
70940799|NCT00113880|141381674|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.71||||0.01|TWO_SIDED|95.0|0.56|0.89||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages combined within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.89|0.56|0.01
70940800|NCT00113880|141381674|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.59||||0.01|TWO_SIDED|95.0|0.41|0.83||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 years within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.83|0.41|0.01
70940801|NCT00113880|141381674|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.68||||0.04|TWO_SIDED|95.0|0.46|0.99||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49 years within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in unvaccinated controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.99|0.46|0.04
70940802|NCT00113880|141381675|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.33||||0.01|TWO_SIDED|95.0|0.27|0.41||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages combined within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.41|0.27|0.01
71075454|NCT03646305|141659789|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal willingness scores||||>0.05
71116411|NCT04283994|141739312|SUPERIORITY||Hazard Ratio (HR)|1.7||||0.027|TWO_SIDED|95.0|1.1|2.5||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Cox|Wald test adjusting for hospital site and dementia diagnosis|Hazard ratio = clinician-facing intervention / usual care. Estimated via cox proportional hazards regression after adjusting for hospital and dementia diagnosis. Exponentiated Wald confidence intervals.|Censoring by death.||2.5|1.1|0.027
70853618|NCT00913458|141195428|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"||||<0.0001
71075455|NCT03646305|141659789|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal willingness to engage with the target thought||||>0.05
71075456|NCT03646305|141659789|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all 4 conditions were equivalent in willingness to engage||||>0.05
71075457|NCT03646305|141659789|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in willingness to engage with the target thought across time.||||>0.05
71075458|NCT03646305|141659789|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on willingness to engage||||>0.05
71116412|NCT04283994|141739312|SUPERIORITY||Hazard Ratio (HR)|0.8||||1.009|TWO_SIDED|95.0|0.6|1.2||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Cox|Wald test adjusting for hospital site and dementia diagnosis.|Hazard ratio = bi-directional intervention / clinician-facing intervention. Estimated via cox proportional hazards regression after adjusting for hospital and dementia diagnosis. Exponentiated Wald confidence intervals.|Censoring by death.||1.2|0.6|1.009
71075459|NCT03646305|141659789|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between 4 conditions on willingness to engage||||>0.05
71075460|NCT03646305|141659790|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.01|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, avoidance of target thought were equivalent across time||||<0.01
71075461|NCT03646305|141659790|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in avoidance of target thought from baseline to post-intervention. Null hypothesis: there would be no significant differences in avoidance from baseline to post-intervention||||>0.05
71075462|NCT03646305|141659790|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress|||||<|0.05|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in avoidance of target thought from post-intervention to follow-up. Null hypothesis: there would be no significant differences in avoidance from post-intervention to follow-up.||||<0.05
71075463|NCT03646305|141659790|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would show equal avoidance of target thought||||>0.05
71075464|NCT03646305|141659790|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal avoidance of target thought||||>0.05
71075465|NCT03646305|141659790|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all 4 conditions were equivalent in avoidance of target thought||||>0.05
71116413|NCT04283994|141739313|SUPERIORITY||Mean Difference (Final Values)|-0.43||||1.366|TWO_SIDED|95.0|-1.55|0.7||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.70|-1.55|1.366
71116414|NCT04283994|141739313|SUPERIORITY||Mean Difference (Final Values)|-0.58||||0.978|TWO_SIDED|95.0|-1.73|0.58||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.58|-1.73|0.978
71116415|NCT04283994|141739313|SUPERIORITY||Mean Difference (Final Values)|0.15||||2.39|TWO_SIDED|95.0|-0.99|1.3||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||1.30|-0.99|2.390
71116416|NCT04283994|141739314|SUPERIORITY||Mean Difference (Final Values)|0.47||||1.125|TWO_SIDED|95.0|-0.57|1.51||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||1.51|-0.57|1.125
71116417|NCT04283994|141739314|SUPERIORITY||Mean Difference (Final Values)|0.91||||0.258|TWO_SIDED|95.0|-0.13|1.94||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||1.94|-0.13|0.258
71116418|NCT04283994|141739314|SUPERIORITY||Mean Difference (Final Values)|-0.44||||1.267|TWO_SIDED|95.0|-1.5|0.63||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.63|-1.5|1.267
71116419|NCT04283994|141739315|SUPERIORITY||Mean Difference (Final Values)|0.32||||1.594|TWO_SIDED|95.0|-0.68|1.32||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||1.32|-0.68|1.594
71116420|NCT04283994|141739315|SUPERIORITY||Mean Difference (Final Values)|0.29||||1.803|TWO_SIDED|95.0|-0.79|1.36||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||1.36|-0.79|1.803
70853619|NCT00913458|141195429|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"||||<0.0001
71075466|NCT03646305|141659790|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in avoidance of target thought across time.||||>0.05
71075467|NCT03646305|141659790|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on avoidance of target thought||||>0.05
71116421|NCT04283994|141739315|SUPERIORITY||Mean Difference (Final Values)|0.03||||2.851|TWO_SIDED|95.0|-1.01|1.07||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||1.07|-1.01|2.851
71116422|NCT04283994|141739316|SUPERIORITY||Mean Difference (Final Values)|-0.28||||1.243|TWO_SIDED|95.0|-0.97|0.4||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.40|-0.97|1.243
70853620|NCT00913458|141195430|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 week and final on therapy"||||<0.0001
71075468|NCT03646305|141659790|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between 4 conditions on avoidance of target thought||||>0.05
71075469|NCT03646305|141659791|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, cognitive delusion were equivalent across time||||>0.05
71075470|NCT03646305|141659791|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of cognitive defusion||||>0.05
71075471|NCT03646305|141659791|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal levels of cognitive defusion||||>0.05
71075472|NCT03646305|141659791|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in levels of cognitive defusion||||>0.05
71075473|NCT03646305|141659791|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in levels of cognitive defusion across time.||||>0.05
71075474|NCT03646305|141659791|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance alpha level .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of cognitive defusion||||>0.05
70853621|NCT00913458|141195431|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||McNemar|||"P-value is from McNemar's test for no change from baseline in response rate.~Week 2, 4, 8, 13, 26, 39, 52 week and final on therapy"||||<0.0001
71116423|NCT04283994|141739316|SUPERIORITY||Mean Difference (Final Values)|-0.33||||1.032|TWO_SIDED|95.0|-1.0|0.35||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.35|-1.00|1.032
71116424|NCT04283994|141739316|SUPERIORITY||Mean Difference (Final Values)|0.04||||2.742|TWO_SIDED|95.0|-0.7|0.78||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.78|-0.70|2.742
71116425|NCT04283994|141739317|SUPERIORITY||Mean Difference (Final Values)|-0.02||||2.658|TWO_SIDED|95.0|-0.26|0.22||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.22|-0.26|2.658
71116426|NCT04283994|141739317|SUPERIORITY||Mean Difference (Final Values)|0.07||||1.523|TWO_SIDED|95.0|-0.14|0.29||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.29|-0.14|1.523
71075475|NCT03646305|141659791|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance alpha level .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between four conditions on levels of cognitive defusion||||>0.05
71075476|NCT03646305|141659792|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, weight dissatisfaction were equivalent across time.||||<0.001
71075477|NCT03646305|141659792|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in weight dissatisfaction from baseline to post-intervention. Null hypothesis: there would be no significant differences in weight dissatisfaction from baseline to post-intervention||||<0.001
71075478|NCT03646305|141659792|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.05|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure differences in weight dissatisfaction from post-intervention to follow-up. Null: there would be no differences in weight dissatisfaction from post-intervention to follow-up||||<0.05
71075479|NCT03646305|141659792|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal weight dissatisfaction||||>0.05
71079448|NCT00482170|141666442|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.837|TWO_SIDED|95.0|0.7|1.56||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.56|0.70|0.837
71079449|NCT00482170|141666442|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.172|TWO_SIDED|95.0|0.87|2.15||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.15|0.87|0.172
71079450|NCT00482170|141666442|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.096|TWO_SIDED|95.0|0.94|2.24||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.24|0.94|0.096
71079451|NCT00482170|141666442|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.164|TWO_SIDED|95.0|0.88|2.08||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||2.08|0.88|0.164
71079452|NCT00482170|141666443|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.356|TWO_SIDED|95.0|0.83|1.69||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.69|0.83|0.356
71079453|NCT00482170|141666443|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.737|TWO_SIDED|95.0|0.73|1.56||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.56|0.73|0.737
71075480|NCT03646305|141659792|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal weight dissatisfaction scores||||>0.05
71075481|NCT03646305|141659792|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA used to analyze Intervention x Activity interaction. Null: On average, all 4 conditions were equivalent in weight dissatisfaction||||>0.05
71075482|NCT03646305|141659792|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in weight dissatisfaction across time.||||>0.05
71075483|NCT03646305|141659792|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on weight dissatisfaction||||>0.05
71075484|NCT03646305|141659792|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between four conditions on weight dissatisfaction||||>0.05
71075485|NCT03646305|141659793|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, appearance dissatisfaction were equivalent across time.||||<0.001
71075486|NCT03646305|141659793|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in appearance dissatisfaction from baseline to post-intervention. Null hypothesis: the control conditions would have no significant difference in appearance dissatisfaction from baseline to post-intervention||||>0.05
71075487|NCT03646305|141659793|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in appearance dissatisfaction from post-intervention to follow-up. Null hypothesis: the control conditions would have no significant difference in appearance dissatisfaction from post-intervention to follow-up.||||<0.001
71116427|NCT04283994|141739317|SUPERIORITY||Mean Difference (Final Values)|-0.09||||1.381|TWO_SIDED|95.0|-0.33|0.15||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.15|-0.33|1.381
71116428|NCT04283994|141739318|SUPERIORITY||Mean Difference (Final Values)|0.04||||2.191|TWO_SIDED|95.0|-0.18|0.25||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.25|-0.18|2.191
71078818|NCT03585712|141665703|OTHER|Is the overall mean change from baseline different from zero? Or did the infringement of schedule regardless the type of infringement lead to a change in mucus score?||||||0.26||||||P value from model testing intercept (does infringement change mucus score?) P-value from a repeated measures mixed model with the period, intervention, sequence and time (visit) as covariates. P-values ≤0.050 are considered significant|Mixed Models Analysis|||"Mixed model for repeated measures using as response delta to Day41, delta to Day42, delta to Day70 and delta to Day71.~Covariates: period, intervention (missed pill or delayed pill), sequence of intervention (missed pill then delayed pill and vice versa), time and subject.~Subject as random effect + time repeated effect within each combination subject\* period"||||0.26
71116429|NCT04283994|141739318|SUPERIORITY||Mean Difference (Final Values)|0.04||||2.138|TWO_SIDED|95.0|-0.19|0.27||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.27|-0.19|2.138
71116430|NCT04283994|141739318|SUPERIORITY||Mean Difference (Final Values)|-0.01||||2.879|TWO_SIDED|95.0|-0.23|22.0||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||022|-0.23|2.879
71116431|NCT00487942|141739351|SUPERIORITY_OR_OTHER||Effect size|-0.04|||||TWO_SIDED|95.0|-0.81|0.73||Inferential statistics were not performed.|ANCOVA|||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.73|-0.81|
71116432|NCT00487942|141739351|SUPERIORITY_OR_OTHER||Effect size|0.09|||||TWO_SIDED|95.0|-0.68|0.86||Inferential statistics were not performed|ANCOVA|||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.86|-0.68|
71116433|NCT00487942|141739351|SUPERIORITY_OR_OTHER||Effect size|0.15|||||TWO_SIDED|95.0|-0.66|0.95||Inferential statistics were not performed.|ANCOVA|||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.95|-0.66|
71116434|NCT00487942|141739352|SUPERIORITY_OR_OTHER||Effect size|0.02|||||TWO_SIDED|95.0|-0.8|0.83||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.83|-0.80|
71116435|NCT00487942|141739352|SUPERIORITY_OR_OTHER||Effect size|0.31|||||TWO_SIDED|95.0|-0.51|1.14||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.14|-0.51|
70853622|NCT00913458|141195432|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.4075|TWO_SIDED|95.0|0.4|7.6|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||7.6|0.4|0.4075
70940803|NCT00113880|141381675|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3||||0.01|TWO_SIDED|95.0|0.22|0.42||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 years within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months||0.42|0.22|0.01
70940804|NCT00113880|141381675|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.34||||0.01|TWO_SIDED|95.0|0.24|0.47||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 years within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.47|0.24|0.01
71075488|NCT03646305|141659793|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal appearance dissatisfaction||||>0.05
71075489|NCT03646305|141659793|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal appearance dissatisfaction scores||||>0.05
71075490|NCT03646305|141659793|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in appearance dissatisfaction||||>0.05
71075491|NCT03646305|141659793|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in appearance dissatisfaction across time.||||>0.05
70853623|NCT00913458|141195432|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.88||||0.0011|TWO_SIDED|95.0|2.4|33.1|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||33.1|2.4|0.0011
71075492|NCT03646305|141659793|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on appearance dissatisfaction||||>0.05
71075493|NCT03646305|141659793|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between four conditions on appearance dissatisfaction||||>0.05
71075494|NCT03646305|141659794|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, body state image satisfaction were equivalent across time||||<0.001
71075495|NCT03646305|141659794|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.05|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure the difference in state body image satisfaction from baseline to post intervention. Null hypothesis: there would be no significant differences in state body image satisfaction from baseline to post intervention.||||<0.05
71075496|NCT03646305|141659794|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure the difference in state body image satisfaction from post intervention to follow-up. Null hypothesis: there would be no significant differences in state body image satisfaction from post-intervention to follow-up.||||<0.001
71116436|NCT00487942|141739352|SUPERIORITY_OR_OTHER||Effect size|0.16|||||TWO_SIDED|95.0|-0.66|0.98||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.98|-0.66|
71116437|NCT00487942|141739353|SUPERIORITY_OR_OTHER||Effect size|0.25|||||TWO_SIDED|95.0|-0.51|1.01||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.01|-0.51|
71116438|NCT00487942|141739353|SUPERIORITY_OR_OTHER||Effect size|-0.1|||||TWO_SIDED|95.0|-0.86|0.66||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.66|-0.86|
70853624|NCT00913458|141195432|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.87||||0.0031|TWO_SIDED|95.0|1.7|13.9|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||13.9|1.7|0.0031
70853625|NCT00913458|141195433|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.5951|TWO_SIDED|95.0|0.3|2.0|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||2.0|0.3|0.5951
71075497|NCT03646305|141659794|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal body state image satisfaction||||>0.05
71075498|NCT03646305|141659794|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal state body satisfaction scores||||>0.05
71075499|NCT03646305|141659794|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in state body image satisfaction||||>0.05
71075500|NCT03646305|141659794|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in state body image satisfaction across time.||||>0.05
71078819|NCT03585712|141665704|OTHER||||||>|0.999||||||p values \> 0.050 (Not Statistically significant)|McNemar|McNemar test comparing agreement in the missed and delayed periods||Absence of risk increase||||>0.999
71078820|NCT03585712|141665704|OTHER|||||||0.655||||||p values \> 0.050 (Not Statistically significant)|McNemar|McNemar test comparing agreement in the missed and delayed periods||Transient risk increase||||0.655
71078821|NCT03585712|141665704|OTHER|||||||0.317||||||p values \> 0.050 (Not Statistically significant)|McNemar|McNemar test comparing agreement in the missed and delayed periods||Prolonged risk increase||||0.317
71078822|NCT03585712|141665705|OTHER||||||<|0.001||||||Indicates significance at the 0.05 level (p-value ≤ 0.05)|McNemar|P-value from an exact kappa test comparing agreement of ovarian status vs the reported perfect use period||A stratified McNemar test (stratification on the site, AGREE option in SAS) was used to compare the distribution of ovarian activity classification in the perfect use period to the delayed and missed pill periods (pairwise vs perfect use). The worst (meaning most risk of ovulation) ovarian activity category in the period was used for the analyses.||||<0.001
71078823|NCT03585712|141665705|OTHER||||||<|0.001||||||Indicates significance at the 0.05 level (p-value ≤ 0.05)|McNemar|P-value from an exact kappa test comparing agreement of ovarian status vs the reported perfect use period.||A stratified McNemar test (stratification on the site, AGREE option in SAS) was used to compare the distribution of ovarian activity classification in the perfect use period to the delayed and missed pill periods (pairwise vs perfect use). The worst (meaning most risk of ovulation) ovarian activity category in the period was used for the analyses.||||<0.001
71078824|NCT03585712|141665706|OTHER|||||||0.127|||||||McNemar|P-value from an exact kappa test comparing agreement of cervical mucus score classification vs the reported perfect use period||Stratified McNemar test (stratification on the site, AGREE option in SAS) to compare the distribution of cervical mucus scores in the perfect use period to the delayed and missed pill periods (pairwise vs perfect use).||||0.127
71116439|NCT00487942|141739353|SUPERIORITY_OR_OTHER||Effect size|0.49|||||TWO_SIDED|95.0|-0.31|1.28||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.28|-0.31|
71116440|NCT00487942|141739354|SUPERIORITY_OR_OTHER||Effect Size|-0.27|||||TWO_SIDED|95.0|-1.03|0.48||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.48|-1.03|
71116441|NCT00487942|141739354|SUPERIORITY_OR_OTHER||Effect Size|0.11|||||TWO_SIDED|95.0|-0.65|0.88||Inferential Statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.88|-0.65|
71116442|NCT00487942|141739354|SUPERIORITY_OR_OTHER||Effect Size|-0.18|||||TWO_SIDED|95.0|-0.97|0.6||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.60|-0.97|
71116443|NCT00487942|141739355|SUPERIORITY_OR_OTHER||Effect Size|-0.32|||||TWO_SIDED|95.0|-1.08|0.44||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.44|-1.08|
71116444|NCT00487942|141739355|SUPERIORITY_OR_OTHER||Effect Size|-0.02|||||TWO_SIDED|95.0|-0.77|0.74||Inferential Statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.74|-0.77|
71116445|NCT00487942|141739355|SUPERIORITY_OR_OTHER||Effect Size|-0.1|||||TWO_SIDED|95.0|-0.89|0.68||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.68|-0.89|
71116446|NCT00487942|141739356|SUPERIORITY_OR_OTHER||Effect Size|0.15|||||TWO_SIDED|95.0|-0.61|0.9||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.90|-0.61|
70853626|NCT00913458|141195433|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.0934|TWO_SIDED|95.0|0.9|5.5|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||5.5|0.9|0.0934
70853627|NCT00913458|141195433|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.85||||0.0314|TWO_SIDED|95.0|1.1|7.4|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||7.4|1.1|0.0314
70853628|NCT00913458|141195434|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.6152|TWO_SIDED|95.0|0.5|2.8|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||2.8|0.5|0.6152
70853629|NCT00913458|141195434|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.36||||0.0432|TWO_SIDED|95.0|1.0|5.4|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||5.4|1.0|0.0432
70853630|NCT00913458|141195434|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.1189|TWO_SIDED|95.0|0.8|4.3|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.3|0.8|0.1189
70853631|NCT00913458|141195435|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.15||||0.0535|TWO_SIDED|95.0|1.0|4.7|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.7|1.0|0.0535
71075501|NCT03646305|141659794|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance alpha level .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on state body image satisfaction||||>0.05
71075502|NCT03646305|141659794|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance alpha level.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between four conditions on state body image satisfaction||||>0.05
71075503|NCT03646305|141659795|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, state body image satisfaction were equivalent across time.||||<0.001
71075504|NCT03646305|141659795|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure differences in anxious mood from baseline to post-intervention. Null hypothesis: there would be no significant difference in anxious mood from baseline to post-intervention.||||<0.001
71075505|NCT03646305|141659795|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in anxious mood from post-intervention to follow-up. Null hypothesis: there would be no significant difference in anxious mood from post-intervention to follow-up||||>0.05
71075506|NCT03646305|141659795|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of anxiety||||>0.05
71078825|NCT03585712|141665706|OTHER|||||||0.018||||||\* Indicates significance at the 0.05 level (p-value ≤ 0.05).|McNemar|P-value from an exact kappa test comparing agreement of cervical mucus score classification vs the reported perfect use period.||Stratified McNemar test (stratification on the site, AGREE option in SAS) to compare the distribution of cervical mucus scores in the perfect use period to the delayed and missed pill periods (pairwise vs perfect use).||||0.018
71078826|NCT04677387|141665720|SUPERIORITY||Mean Difference (Final Values)|-0.00325||||0.473|TWO_SIDED||||||Regression, Linear|Linear regression using a Generalized Estimating Equation (GEE) model clustering on pharmacy.||||||0.473
70940805|NCT00113880|141381675|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.42||||0.01|TWO_SIDED|95.0|0.23|0.75||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49 years within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.75|0.23|0.01
70940806|NCT00113880|141381675|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.38||||0.01|TWO_SIDED|95.0|0.33|0.44||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages combined within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.44|0.33|0.01
71075507|NCT03646305|141659795|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal levels of anxiety||||>0.05
71075508|NCT03646305|141659795|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in levels of anxiety||||>0.05
70940807|NCT00113880|141381675|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.4||||0.01|TWO_SIDED|95.0|0.32|0.5||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 years within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.50|0.32|0.01
70940808|NCT00113880|141381675|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.36||||0.01|TWO_SIDED|95.0|0.28|0.45||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 years within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.45|0.28|0.01
71078827|NCT04677387|141665721|SUPERIORITY|||||||0.007|||||||Regression, Linear|Linear regression with Generalized Estimating Equation (GEE) model.||||||.007
71078828|NCT04677387|141665722|SUPERIORITY|||||||0.002|||||||Regression, Linear|Linear regression with a Generalized Estimating Equation (GEE) model.||||||.002
71078829|NCT04677387|141665723|SUPERIORITY|||||||0.169|||||||Regression, Linear|Linear regression with Generalized Estimating Equation (GEE) model.||||||0.169
71078830|NCT01964716|141665734|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-0.8|||||TWO_SIDED|97.5|-3.4|1.2||||||Serotype 1: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||1.2|-3.4|
71078831|NCT01964716|141665734|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-0.8|||||TWO_SIDED|97.5|-3.7|1.6||||||Serotype 3: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||1.6|-3.7|
71078832|NCT01964716|141665734|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|0.0|||||TWO_SIDED|97.5|-2.3|2.4||||||Serotype 4: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.4|-2.3|
71078833|NCT01964716|141665734|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-1.2|||||TWO_SIDED|97.5|-5.4|2.8||||||Serotype 5: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.8|-5.4|
71078834|NCT01964716|141665734|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-1.2|||||TWO_SIDED|97.5|-5.3|2.6||||||Serotype 6A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.6|-5.3|
70853632|NCT00913458|141195435|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.22||||0.0064|TWO_SIDED|95.0|1.4|7.5|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||7.5|1.4|0.0064
70853633|NCT00913458|141195435|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.3696|TWO_SIDED|95.0|0.6|3.6|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||3.6|0.6|0.3696
70853634|NCT00913458|141195436|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.0788|TWO_SIDED|95.0|0.9|5.2|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||5.2|0.9|0.0788
71075509|NCT03646305|141659795|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in levels of anxiety across time||||>0.05
71075510|NCT03646305|141659795|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of anxiety||||>0.05
71116447|NCT00487942|141739356|SUPERIORITY_OR_OTHER||Effect Size|0.25|||||TWO_SIDED|95.0|-0.5|1.01||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.01|-0.50|
71116448|NCT00487942|141739356|SUPERIORITY_OR_OTHER||Effect Size|0.46|||||TWO_SIDED|95.0|-0.34|1.25||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.25|-0.34|
71116449|NCT00487942|141739357|SUPERIORITY_OR_OTHER||Effect Size|0.45|||||TWO_SIDED|95.0|-0.33|1.23||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.23|-0.33|
71116450|NCT00487942|141739357|SUPERIORITY_OR_OTHER||Effect Size|0.34|||||TWO_SIDED|95.0|-0.42|1.1||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.10|-0.42|
71116451|NCT00487942|141739357|SUPERIORITY_OR_OTHER||Effect Size|0.13|||||TWO_SIDED|95.0|-0.68|0.93||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.93|-0.68|
71116452|NCT00487942|141739358|SUPERIORITY_OR_OTHER||Effect Size|0.39|||||TWO_SIDED|95.0|-0.37|1.15||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.15|-0.37|
70853635|NCT00913458|141195436|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.57||||0.0007|TWO_SIDED|95.0|1.9|11.0|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||11.0|1.9|0.0007
70853636|NCT00913458|141195436|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1||||0.0676|TWO_SIDED|95.0|0.9|4.7|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.7|0.9|0.0676
71075511|NCT03646305|141659795|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between the four conditions on levels of anxiety||||>0.05
71075512|NCT03646305|141659796|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, levels of depressive mood were equivalent across time.||||<0.001
71075513|NCT03646305|141659796|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in depressive mood from depressive mood from baseline to post-intervention||||<0.001
71075514|NCT03646305|141659796|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in depressive mood from post-intervention to follow-up. Null hypothesis: there would be no significant differences in depressive mood from post-intervention to follow-up.||||>0.05
71075515|NCT03646305|141659796|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of depressive mood||||>0.05
71075516|NCT03646305|141659796|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal levels of depressive mood||||>0.05
71078835|NCT01964716|141665734|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|0.0|||||TWO_SIDED|97.5|-4.7|4.7||||||Serotype 6B: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||4.7|-4.7|
70940809|NCT00113880|141381675|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.41||||0.01|TWO_SIDED|95.0|0.27|0.6||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49 years within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.60|0.27|0.01
70940810|NCT00113880|141381675|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.47||||0.05|TWO_SIDED|95.0|0.21|0.99||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 years, PD2 within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.99|0.21|0.05
70940811|NCT00113880|141381676|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92||||0.01|TWO_SIDED|95.0|0.86|0.98||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages combined, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.98|0.86|0.01
70940812|NCT00113880|141381676|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.83||||0.01|TWO_SIDED|95.0|0.75|0.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 yrs., within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months||0.92|0.75|0.01
71075517|NCT03646305|141659796|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in levels of depressive mood||||>0.05
71075518|NCT03646305|141659796|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in levels of depressive mood across time||||>0.05
71075519|NCT03646305|141659796|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of depressive mood||||>0.05
71075520|NCT03646305|141659796|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between 4 conditions on levels of depressive mood||||>0.05
71075521|NCT03646305|141659797|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, levels of happiness were equivalent across time||||>0.05
70940813|NCT00113880|141381676|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.87||||0.01|TWO_SIDED|95.0|0.81|0.94||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: All ages, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.94|0.81|0.01
70940814|NCT00113880|141381676|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79||||0.01|TWO_SIDED|95.0|0.7|0.88||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.88|0.70|0.01
70940815|NCT00113880|141381676|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49||||0.01|TWO_SIDED|95.0|0.29|0.79||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8yrs, within 180 days, PD2. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.79|0.29|0.01
70940816|NCT00113880|141381677|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.48||||0.01|TWO_SIDED|95.0|0.45|0.51||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages combined, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.51|0.45|0.01
70940817|NCT00113880|141381677|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.51||||0.01|TWO_SIDED|95.0|0.47|0.56||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months||0.56|0.47|0.01
70940818|NCT00113880|141381677|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.42||||0.01|TWO_SIDED|95.0|0.38|0.46||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.46|0.38|0.01
71075522|NCT03646305|141659797|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of happiness||||>0.05
71075523|NCT03646305|141659797|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal levels of happiness||||>0.05
71075524|NCT03646305|141659797|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in levels of happiness||||>0.05
71078836|NCT01964716|141665734|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-0.4|||||TWO_SIDED|97.5|-2.7|1.6||||||Serotype 7F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||1.6|-2.7|
71075525|NCT03646305|141659797|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in levels of happiness across time.||||>0.05
71075526|NCT03646305|141659797|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of happiness||||>0.05
71075527|NCT03646305|141659797|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no differences between four conditions on levels of happiness||||>0.05
71075528|NCT03646305|141659798|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, levels of confidence were equivalent across time.||||>0.05
71075529|NCT03646305|141659798|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of confidence||||>0.05
71075530|NCT03646305|141659798|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal levels of confidence||||>0.05
71075531|NCT03646305|141659798|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in levels of confidence||||>0.05
71116453|NCT00487942|141739358|SUPERIORITY_OR_OTHER||Effect Size|-0.05|||||TWO_SIDED|95.0|-0.81|0.7||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.70|-0.81|
71116454|NCT00487942|141739358|SUPERIORITY_OR_OTHER||Effect Size|-0.01|||||TWO_SIDED|95.0|-0.8|0.77||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.77|-0.80|
71116455|NCT00487942|141739359|SUPERIORITY_OR_OTHER||Effect Size|-0.99|||||TWO_SIDED|95.0|-1.79|-0.19||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||-0.19|-1.79|
71116456|NCT00487942|141739359|SUPERIORITY_OR_OTHER||Effect Size|-0.66|||||TWO_SIDED|95.0|-1.44|0.11||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.11|-1.44|
71116457|NCT00487942|141739359|SUPERIORITY_OR_OTHER||Effect Size|-0.03|||||TWO_SIDED|95.0|-0.82|0.75||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.75|-0.82|
70940819|NCT00113880|141381677|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.57||||0.01|TWO_SIDED|95.0|0.49|0.67||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.67|0.49|0.01
70940820|NCT00113880|141381677|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.51||||0.01|TWO_SIDED|95.0|0.33|0.76||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 yrs, within 180 days, PD2. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.76|0.33|0.01
70940821|NCT00113880|141381677|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.42||||0.01|TWO_SIDED|95.0|0.39|0.45||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates event rates were presented per 1,000 person-months.||0.45|0.39|0.01
70940822|NCT00113880|141381677|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.42||||0.01|TWO_SIDED|95.0|0.38|0.47||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.47|0.38|0.01
71075532|NCT03646305|141659798|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in levels of confidence across time.||||>0.05
71117722|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-60.09|||<|0.001|TWO_SIDED|95.0|-76.15|-44.02||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-44.02|-76.15|<0.001
71117723|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-63.45|||<|0.001|TWO_SIDED|95.0|-79.64|-47.27||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-47.27|-79.64|<0.001
71117724|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-53.41|||<|0.001|TWO_SIDED|95.0|-70.1|-36.72||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-36.72|-70.10|<0.001
70940823|NCT00113880|141381677|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.37||||0.01|TWO_SIDED|95.0|0.34|0.41||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.41|0.34|0.01
70940824|NCT00113880|141381677|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.58||||0.05|TWO_SIDED|95.0|0.49|0.68||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.68|0.49|0.05
70940825|NCT00113880|141381677|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.28||||0.01|TWO_SIDED|95.0|0.15|0.52||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 yrs, within 180 days, PD2. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/Rad event rates were presented per 1,000 person-months.||0.52|0.15|0.01
70940826|NCT00113880|141381677|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75||||0.01|TWO_SIDED|95.0|0.66|0.85||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Wheezing/SOB event rates were presented per 1,000 person-months.||0.85|0.66|0.01
70940827|NCT00113880|141381677|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.83||||0.02|TWO_SIDED|95.0|0.7|0.97||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Wheezing/SOB event rates were presented per 1,000 person-months.||0.97|0.70|0.02
70940828|NCT00113880|141381677|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.72||||0.01|TWO_SIDED|95.0|0.58|0.88||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Wheezing/SOB event rates were presented per 1,000 person-months.||0.88|0.58|0.01
71116458|NCT00487942|141739360|SUPERIORITY_OR_OTHER||Effect Size|0.46|||||TWO_SIDED|95.0|-0.3|1.23||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.23|-0.30|
70940829|NCT00113880|141381677|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.47||||0.01|TWO_SIDED|95.0|0.27|0.78||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Wheezing/SOB event rates were presented per 1,000 person-months.||0.78|0.27|0.01
70940830|NCT00113880|141381678|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.0||||0.04|TWO_SIDED|95.0|0.0|0.82||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Encephalitis/encephalopathy event rates were presented per 1,000 person-months.||0.82|0.00|0.04
71075533|NCT03646305|141659798|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of happiness||||>0.05
71075534|NCT03646305|141659798|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no differences between four conditions on levels of happiness||||>0.05
71117725|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-9.14||||0.137|TWO_SIDED|95.0|-21.18|2.9||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.90|-21.18|0.137
71075535|NCT03646305|141659799|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, level of self-esteem were equivalent across time.||||<0.05
71075536|NCT03646305|141659799|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in self-esteem from post-intervention to follow-up. Null hypothesis: there would be no significant differences in self-esteem from post-intervention to follow-up.||||<0.001
71075537|NCT03646305|141659799|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of self-esteem||||>0.05
71075538|NCT03646305|141659799|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal levels of self-esteem||||>0.05
71075539|NCT03646305|141659799|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA used to analyze Intervention x Activity interaction. Null: On average, all four conditions have equivalent levels of self-esteem||||>0.05
71075540|NCT03646305|141659799|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions have equivalent levels of self-esteem across time.||||>0.05
71075541|NCT03646305|141659799|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of self-esteem||||>0.05
71075542|NCT03646305|141659799|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no differences between four conditions on levels of self-esteem||||>0.05
71075543|NCT03646305|141659800|OTHER|Mediation Analysis that examined whether greater homework adherence strengthened the relationship between condition and outcome|||||>|0.05|||||||Mediation Analyses|||All mediation analyses were conducted using the PROCESS SPSS macro version 3.2 (Hayes, 2018). We tested model 4, which includes one outcome variable, one predictor, one mediator, and room for covariates. We examined the meditational effect of homework adherence on the relationship between intervention and each outcome measure. Null: homework adherence does not mediate any relationships between intervention condition and outcome measures.||||>0.05
71075544|NCT03646305|141659800|OTHER|Mediation Analysis that examined whether greater homework adherence strengthened the relationship between condition and outcome|||||>|0.05|||||||Mediation Analyses|||All mediation analyses were conducted using the PROCESS SPSS macro version 3.2 (Hayes, 2018). We tested model 4, which includes one outcome variable, one predictor, one mediator, and room for covariates. We examined the meditational effect of homework adherence on the relationship between activity and each outcome measure. Null: homework adherence does not mediate any relationships between activity condition and outcome measures.||||>0.05
71075545|NCT03646305|141659801|OTHER|Thought-shape fusion was examined as a potential moderator of the relationship between intervention condition and outcome measures.|||||<|0.001||||||No other outcome measure was moderated by thought-shape fusion scores.|Moderation Analyses|||All moderation analyses were conducted using the PROCESS SPSS macro version 3.2 (Hayes, 2018). We tested model 1, which includes one outcome variable, one predictor, and one moderator. Thought-shape fusion was examined as a potential moderator of the relationship between intervention condition and outcome measures. Null: thought-shape fusion does not significantly moderate the relationship between intervention condition and state self-esteem||||<0.001
71075546|NCT04015518|141659802|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-10.5|STANDARD_ERROR_OF_MEAN|8.5||0.2179|TWO_SIDED|95.0|-27.4|6.3|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||6.3|-27.4|0.2179
71075547|NCT04015518|141659802|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-14.6|STANDARD_ERROR_OF_MEAN|8.5||0.0883|TWO_SIDED|95.0|-31.5|2.2|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||2.2|-31.5|0.0883
71075548|NCT04015518|141659802|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-12.6|STANDARD_ERROR_OF_MEAN|8.5||0.1414|TWO_SIDED|95.0|-29.4|4.3|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||4.3|-29.4|0.1414
71075549|NCT04015518|141659802|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-5.3|STANDARD_ERROR_OF_MEAN|7.0||0.4514|TWO_SIDED|95.0|-19.1|8.6|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||8.6|-19.1|0.4514
71116459|NCT00487942|141739360|SUPERIORITY_OR_OTHER||Effect Size|0.08|||||TWO_SIDED|95.0|-0.68|0.83||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.83|-0.68|
71116460|NCT00487942|141739360|SUPERIORITY_OR_OTHER||Effect Size|0.81|||||TWO_SIDED|95.0|0.0|1.63||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.63|-0.00|
71116461|NCT00487942|141739361|SUPERIORITY_OR_OTHER||Effect Size|-0.39|||||TWO_SIDED|95.0|-1.16|0.37||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.37|-1.16|
71116462|NCT00487942|141739361|SUPERIORITY_OR_OTHER||Effect Size|-0.45|||||TWO_SIDED|95.0|-1.21|0.31||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.31|-1.21|
70853637|NCT00913458|141195437|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.56||||0.0548|TWO_SIDED|95.0|1.0|59.5|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||59.5|1.0|0.0548
71075550|NCT04015518|141659802|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.212||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.2120
71075551|NCT04015518|141659802|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.1057||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1057
71075552|NCT04015518|141659802|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.5241||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.5241
71078837|NCT01964716|141665734|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-0.4|||||TWO_SIDED|97.5|-3.8|2.8||||||Serotype 9V: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.8|-3.8|
71116463|NCT00487942|141739361|SUPERIORITY_OR_OTHER||Effect Size|-0.2|||||TWO_SIDED|95.0|-0.99|0.58||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.58|-0.99|
71116464|NCT00487942|141739362|SUPERIORITY_OR_OTHER||Effect Size|0.47|||||TWO_SIDED|95.0|-0.3|1.23||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.23|-0.30|
71116465|NCT00487942|141739362|SUPERIORITY_OR_OTHER||Effect Size|0.28|||||TWO_SIDED|95.0|-0.48|1.04||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.04|-0.48|
70853638|NCT00913458|141195437|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.18||||0.0166|TWO_SIDED|95.0|1.6|94.2|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||94.2|1.6|0.0166
71075553|NCT04015518|141659802|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.2773||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.2773
71075554|NCT04015518|141659802|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.3867||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.3867
71075555|NCT04015518|141659803|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-6.1|STANDARD_ERROR_OF_MEAN|6.7|||TWO_SIDED|95.0|-19.3|7.1|||||Difference was calculated as Speso - placebo.|||7.1|-19.3|
71116466|NCT00487942|141739362|SUPERIORITY_OR_OTHER||Effect size|0.14|||||TWO_SIDED|95.0|-0.64|0.93||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.93|-0.64|
71116467|NCT00487942|141739363|SUPERIORITY_OR_OTHER||Effect size|-0.23|||||TWO_SIDED|95.0|-0.99|0.52||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.52|-0.99|
71116468|NCT00487942|141739363|SUPERIORITY_OR_OTHER||Effect size|0.34|||||TWO_SIDED|95.0|-0.42|1.1||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.10|-0.42|
71116469|NCT00487942|141739363|SUPERIORITY_OR_OTHER||Effect size|0.06|||||TWO_SIDED|95.0|-0.72|0.85||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.85|-0.72|
71075556|NCT04015518|141659803|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-5.4|STANDARD_ERROR_OF_MEAN|6.8|||TWO_SIDED|95.0|-18.8|8.0|||||Difference was calculated as Speso - placebo.|||8.0|-18.8|
71075557|NCT04015518|141659803|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-3.5|STANDARD_ERROR_OF_MEAN|6.6|||TWO_SIDED|95.0|-16.6|9.7|||||Difference was calculated as Speso - placebo.|||9.7|-16.6|
71075558|NCT04015518|141659803|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-9.4|STANDARD_ERROR_OF_MEAN|5.5|||TWO_SIDED|95.0|-20.3|1.4|||||Difference was calculated as Speso - placebo.|||1.4|-20.3|
71116470|NCT00487942|141739364|SUPERIORITY_OR_OTHER||Effect size|-0.2|||||TWO_SIDED|95.0|-0.95|0.56||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.56|-0.95|
71116471|NCT00487942|141739364|SUPERIORITY_OR_OTHER||Effect size|-0.35|||||TWO_SIDED|95.0|-1.11|0.41||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.41|-1.11|
71116472|NCT00487942|141739364|SUPERIORITY_OR_OTHER||Effect size|-0.16|||||TWO_SIDED|95.0|-0.95|0.62||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.62|-0.95|
71116473|NCT00487942|141739365|SUPERIORITY_OR_OTHER||Effect size|-0.51|||||TWO_SIDED|95.0|-1.3|0.27||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.27|-1.30|
71116474|NCT00487942|141739365|SUPERIORITY_OR_OTHER||Effect size|0.55|||||TWO_SIDED|95.0|-0.25|1.35||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.35|-0.25|
71116475|NCT00487942|141739365|SUPERIORITY_OR_OTHER||Effect size|0.02|||||TWO_SIDED|95.0|-0.78|0.82||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.82|-0.78|
71116476|NCT00487942|141739366|SUPERIORITY_OR_OTHER||Effect size|-0.64|||||TWO_SIDED|95.0|-1.43|0.15||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.15|-1.43|
71116477|NCT00487942|141739366|SUPERIORITY_OR_OTHER||Effect Size|-0.26|||||TWO_SIDED|95.0|-1.05|0.53||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.53|-1.05|
71116478|NCT00487942|141739366|SUPERIORITY_OR_OTHER||Effect size|-0.1|||||TWO_SIDED|95.0|-0.9|0.7||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.70|-0.90|
70940831|NCT00113880|141381679|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.01|TWO_SIDED|95.0|0.47|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.91|0.47|0.01
70940832|NCT00113880|141381679|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.34||||0.01|TWO_SIDED|95.0|0.21|0.57||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox||Population: 18-49 yrs, within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.57|0.21|0.01
71075559|NCT04015518|141659804|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-4.1|STANDARD_ERROR_OF_MEAN|6.9||0.5595|TWO_SIDED|95.0|-17.7|9.6|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||9.6|-17.7|0.5595
71075560|NCT04015518|141659804|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|0.9|STANDARD_ERROR_OF_MEAN|6.9||0.8968|TWO_SIDED|95.0|-12.7|14.5|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||14.5|-12.7|0.8968
71075561|NCT04015518|141659804|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-4.2|STANDARD_ERROR_OF_MEAN|6.9||0.5456|TWO_SIDED|95.0|-17.9|9.5|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||9.5|-17.9|0.5456
71075562|NCT04015518|141659804|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-7.7|STANDARD_ERROR_OF_MEAN|5.7||0.1762|TWO_SIDED|95.0|-19.0|3.5|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||3.5|-19.0|0.1762
71075563|NCT04015518|141659804|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.1726||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1726
71075564|NCT04015518|141659804|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.2353||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.2353
71116479|NCT00487942|141739367|SUPERIORITY_OR_OTHER||Effect size|-0.15|||||TWO_SIDED|95.0|-0.92|0.63||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.63|-0.92|
71116480|NCT00487942|141739367|SUPERIORITY_OR_OTHER||Effect size|0.25|||||TWO_SIDED|95.0|-0.54|1.04||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.04|-0.54|
71116481|NCT00487942|141739367|SUPERIORITY_OR_OTHER||Effect size|-0.31|||||TWO_SIDED|95.0|-1.12|0.49||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.49|-1.12|
70853639|NCT00913458|141195437|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.3619|TWO_SIDED|95.0|0.6|4.5|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.5|0.6|0.3619
71075565|NCT04015518|141659804|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.1346||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1346
71078838|NCT01964716|141665734|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-0.8|||||TWO_SIDED|97.5|-4.3|2.5||||||Serotype 14: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.5|-4.3|
71078839|NCT01964716|141665734|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|1.2|||||TWO_SIDED|97.5|-1.6|4.5||||||Serotype 18C: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||4.5|-1.6|
71078840|NCT01964716|141665734|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|0.8|||||TWO_SIDED|97.5|-1.6|3.6||||||Serotype 19A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||3.6|-1.6|
71078841|NCT01964716|141665734|SUPERIORITY_OR_OTHER||percentage difference|-0.4|||||TWO_SIDED|97.5|-4.4|3.5||||||Serotype 19F: Exact 2-sided confidence interval (based on Chan \& Zhang) for the difference in proportions, 13vPnC multidose vial (MDV) - 13vPnC single-dose syringe (SDS), expressed as a percentage was analyzed.||3.5|-4.4|
71078842|NCT01964716|141665734|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|0.0|||||TWO_SIDED|97.5|-4.3|4.4||||||Serotype 23F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||4.4|-4.3|
70853640|NCT00913458|141195438|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.23||||0.0017|TWO_SIDED|95.0|1.6|6.7|||Regression, Logistic|Odds ratios, p-values, and 95% CIs are based on a logistic regression model with treatment as the only factor.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||6.7|1.6|0.0017
70853641|NCT00913458|141195438|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.05|||<|0.0001|TWO_SIDED|95.0|4.4|28.0|||Regression, Logistic|Odds ratios, p-values, and 95% CIs are based on a logistic regression model with treatment as the only factor.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||28.0|4.4|<0.0001
71078843|NCT01964716|141665735|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.03|||||TWO_SIDED|97.5|0.87|1.22||||||Serotype 1: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.22|0.87|
71078844|NCT01964716|141665735|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|0.79|||||TWO_SIDED|97.5|0.71|0.9||||||Serotype 3: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||0.90|0.71|
71078845|NCT01964716|141665735|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.0|||||TWO_SIDED|97.5|0.86|1.18||||||Serotype 4: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.18|0.86|
71078846|NCT01964716|141665735|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.01|||||TWO_SIDED|97.5|0.85|1.19||||||Serotype 5: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.19|0.85|
70940833|NCT00113880|141381679|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.01|TWO_SIDED|95.0|0.47|0.77||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.77|0.47|0.01
70940834|NCT00113880|141381679|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.01|TWO_SIDED|95.0|0.23|0.48||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 yrs, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.48|0.23|0.01
70940835|NCT00113880|141381680|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.01|TWO_SIDED|95.0|0.47|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.91|0.47|0.01
70940836|NCT00113880|141381680|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.34||||0.01|TWO_SIDED|95.0|0.21|0.57||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox||Population: 18-49 yrs, within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.57|0.21|0.01
70940837|NCT00113880|141381680|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.01|TWO_SIDED|95.0|0.47|0.77||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.77|0.47|0.01
70940838|NCT00113880|141381680|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.01|TWO_SIDED|95.0|0.23|0.48||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 yrs, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.48|0.23|0.01
70940839|NCT00113880|141381681|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.01|TWO_SIDED|95.0|0.57|0.73||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.||0.73|0.57|0.01
70940840|NCT00113880|141381681|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43||||0.01|TWO_SIDED|95.0|0.36|0.51||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox||Population: 18-49 yrs, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.||0.51|0.36|0.01
70940841|NCT00113880|141381682|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29||||0.01|TWO_SIDED|95.0|0.26|0.33||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.||0.33|0.26|0.01
71075566|NCT04015518|141659804|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.195||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1950
71075567|NCT04015518|141659804|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.1681||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1681
71075568|NCT04015518|141659805|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.2812|TWO_SIDED|95.0|-1.8|0.5|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||0.5|-1.8|0.2812
70940842|NCT00113880|141381682|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.16||||0.01|TWO_SIDED|95.0|0.13|0.18||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox||Population: 18-49 yrs, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.||0.18|0.13|0.01
70940843|NCT00113880|141381683|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.16||||0.04|TWO_SIDED|95.0|0.03|0.93||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Sinusitis event rates were presented per 1,000 person-months.||0.93|0.03|0.04
71075569|NCT04015518|141659805|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-0.6|STANDARD_ERROR_OF_MEAN|0.6||0.3357|TWO_SIDED|95.0|-1.7|0.6|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||0.6|-1.7|0.3357
71075570|NCT04015518|141659805|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-0.8|STANDARD_ERROR_OF_MEAN|0.6||0.1809|TWO_SIDED|95.0|-2.0|0.4|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||0.4|-2.0|0.1809
71075571|NCT04015518|141659805|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.8322|TWO_SIDED|95.0|-1.1|0.9|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||0.9|-1.1|0.8322
71075572|NCT04015518|141659805|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.4035||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.4035
70853642|NCT00913458|141195438|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.42||||0.0111|TWO_SIDED|95.0|1.3|8.8|||Regression, Logistic|Odds ratios, p-values, and 95% CIs are based on a logistic regression model with treatment as the only factor.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||8.8|1.3|0.0111
71079454|NCT00482170|141666443|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.156|TWO_SIDED|95.0|0.9|1.91||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.91|0.90|0.156
71079455|NCT00482170|141666443|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.29|TWO_SIDED|95.0|0.85|1.76||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.76|0.85|0.290
71079456|NCT00482170|141666444|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.065|TWO_SIDED|95.0|0.5|1.02||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.02|0.50|0.065
71079457|NCT00482170|141666444|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.1|TWO_SIDED|95.0|0.5|1.06||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.06|0.50|0.100
71079458|NCT00482170|141666444|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.298|TWO_SIDED|95.0|0.54|1.21||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.21|0.54|0.298
71079459|NCT00482170|141666444|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.148|TWO_SIDED|95.0|0.51|1.11||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.11|0.51|0.148
71075573|NCT04015518|141659805|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.2563||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.2563
71075574|NCT04015518|141659805|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.681||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.6810
71075575|NCT04015518|141659805|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.4665||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.4665
71075576|NCT04015518|141659805|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.5565||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.5565
71075577|NCT04015518|141659806|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.042|||||TWO_SIDED|95.0|-0.17|0.281|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.281|-0.170|
71075578|NCT04015518|141659806|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.195|||||TWO_SIDED|95.0|-0.048|0.432|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.432|-0.048|
71075579|NCT04015518|141659806|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.27|||||TWO_SIDED|95.0|0.02|0.496|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.496|0.020|
71075580|NCT04015518|141659806|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.129|||||TWO_SIDED|95.0|-0.067|0.314|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.314|-0.067|
71075581|NCT04015518|141659806|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0613||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0613
71075582|NCT04015518|141659806|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0628||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0628
71075583|NCT04015518|141659806|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.1449||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1449
71075584|NCT04015518|141659806|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.046||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0460
71075585|NCT04015518|141659806|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0677||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0677
71075586|NCT04015518|141659807|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.063|||||TWO_SIDED|95.0|-0.069|0.256|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.256|-0.069|
71075587|NCT04015518|141659807|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.188|||||TWO_SIDED|95.0|0.018|0.405|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.405|0.018|
70853643|NCT00913458|141195439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.66||||0.0328|TWO_SIDED|95.0|-16.6|-0.7|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-0.7|-16.6|0.0328
71075588|NCT04015518|141659807|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.102|||||TWO_SIDED|95.0|-0.042|0.303|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.303|-0.042|
71116482|NCT00487942|141739368|SUPERIORITY_OR_OTHER||Effect size|-0.44|||||TWO_SIDED|95.0|-1.22|0.33||Inferential statistics not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the Trails B Test score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.33|-1.22|
71075589|NCT04015518|141659807|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.113|||||TWO_SIDED|95.0|-0.018|0.25|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.250|-0.018|
71075590|NCT04015518|141659807|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0536||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0536
71075591|NCT04015518|141659807|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0476||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0476
71075592|NCT04015518|141659807|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.1076||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1076
71075593|NCT04015518|141659807|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0606||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0606
71075594|NCT04015518|141659807|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0824||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0824
71075595|NCT04015518|141659808|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.211|||||TWO_SIDED|95.0|0.04|0.422|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.422|0.040|
71075596|NCT04015518|141659808|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.13|||||TWO_SIDED|95.0|-0.018|0.339|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.339|-0.018|
71117726|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-6.34||||0.311|TWO_SIDED|95.0|-18.39|5.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||5.71|-18.39|0.311
70940844|NCT00113880|141381683|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.02|TWO_SIDED|95.0|0.4|0.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|URI event rates were presented per 1,000 person-months.||0.92|0.40|0.02
70940845|NCT00113880|141381683|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49||||0.01|TWO_SIDED|95.0|0.28|0.84||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 years, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|URI event rates were presented per 1,000 person-months.||0.84|0.28|0.01
71075597|NCT04015518|141659808|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.125|||||TWO_SIDED|95.0|-0.022|0.328|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.328|-0.022|
70940846|NCT00113880|141381683|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29||||0.02|TWO_SIDED|95.0|0.1|0.78||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 years, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|URI event rates were presented per 1,000 person-months.||0.78|0.10|0.02
71075598|NCT04015518|141659808|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.144|||||TWO_SIDED|95.0|0.009|0.282|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.282|0.009|
71075599|NCT04015518|141659808|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0333||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0333
71075600|NCT04015518|141659808|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0221||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regime"||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0221
71075601|NCT04015518|141659808|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0707||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0707
71075602|NCT04015518|141659808|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0578||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0578
71116483|NCT00487942|141739368|SUPERIORITY_OR_OTHER||Effect size|-0.89|||||TWO_SIDED|95.0|-1.69|-0.08||Inferential statistics not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the Trails B Test score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||-0.08|-1.69|
71075603|NCT04015518|141659808|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0771||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0771
71075604|NCT04015518|141659809|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.202|||||TWO_SIDED|95.0|-0.005|0.427|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.427|-0.005|
71075605|NCT04015518|141659809|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.17|||||TWO_SIDED|95.0|-0.032|0.401|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.401|-0.032|
71075606|NCT04015518|141659809|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.248|||||TWO_SIDED|95.0|0.032|0.471|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.471|0.032|
71075607|NCT04015518|141659809|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.202|||||TWO_SIDED|95.0|0.024|0.367|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.367|0.024|
71075608|NCT04015518|141659809|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0158||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0158
71075609|NCT04015518|141659809|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.012||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0120
71078847|NCT01964716|141665735|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.03|||||TWO_SIDED|97.5|0.86|1.22||||||Serotype 6A: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.22|0.86|
71116484|NCT00487942|141739368|SUPERIORITY_OR_OTHER||Effect size|-0.13|||||TWO_SIDED|95.0|-0.95|0.7||Inferential statistics not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the Trails B Test score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.70|-0.95|
71116485|NCT00487942|141739414|SUPERIORITY_OR_OTHER||Effect size|0.12|||||TWO_SIDED|95.0|-0.76|1.0||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SCoRS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.0|-0.76|
70940847|NCT00113880|141381683|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.78||||0.02|TWO_SIDED|95.0|0.63|0.96||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Any acute resp. tract event rates were presented per 1,000 person-months.||0.96|0.63|0.02
71075610|NCT04015518|141659809|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0429||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0429
71075611|NCT04015518|141659809|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0229||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0229
71075612|NCT04015518|141659809|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.03||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0300
71075613|NCT04015518|141659810|OTHER|MMRM included 'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-18.7|STANDARD_ERROR_OF_MEAN|9.3|||TWO_SIDED|95.0|-37.2|-0.2|||||Difference was calculated as Speso - placebo.|||-0.2|-37.2|
71075614|NCT04015518|141659810|OTHER|MMRM included 'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-19.3|STANDARD_ERROR_OF_MEAN|9.6|||TWO_SIDED|95.0|-38.3|-0.2|||||Difference was calculated as Speso - placebo.|||-0.2|-38.3|
71075615|NCT04015518|141659810|OTHER|MMRM included 'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-26.6|STANDARD_ERROR_OF_MEAN|9.5|||TWO_SIDED|95.0|-45.5|-7.8|||||Difference was calculated as Speso - placebo.|||-7.8|-45.5|
71075616|NCT04015518|141659810|OTHER|MMRM included 'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-5.4|STANDARD_ERROR_OF_MEAN|7.9|||TWO_SIDED|95.0|-21.1|10.2|||||Difference was calculated as Speso - placebo.|||10.2|-21.1|
71075617|NCT00386425|141659811|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||p-value is for change to Day 7|t-test, 2 sided|||||||0.011
71075618|NCT00386425|141659812|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||p-value is for the moderate Protein C Deficiency (difference in change of pc between alt and standard groups)|t-test, 2 sided|||||||0.047
71116486|NCT00487942|141739414|SUPERIORITY_OR_OTHER||Effect size|-0.33|||||TWO_SIDED|95.0|-1.15|0.48||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SCoRS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.48|-1.15|
71116487|NCT00487942|141739414|SUPERIORITY_OR_OTHER||Effect size|0.27|||||TWO_SIDED|95.0|-0.61|1.15||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SCoRS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.15|-0.61|
70853644|NCT00913458|141195439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.64|||<|0.0001|TWO_SIDED|95.0|-30.1|-13.2|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-13.2|-30.1|<0.0001
71075619|NCT00386425|141659812|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||p-value is for the severe Protein C Deficiency (difference in change of pc between alt and standard groups)|t-test, 2 sided|||||||0.063
71075620|NCT00386425|141659813|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||p-value is for Day 28 mortality|Fisher Exact|||||||0.030
71075621|NCT00386425|141659814|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||p-value is for Day 90 mortality|Fisher Exact|||||||0.090
71075622|NCT00386425|141659815|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||p-value is for total SOFA difference between alternative and standard therapy|t-test, 2 sided|||||||0.190
71075623|NCT00386425|141659815|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||p-value is for difference in cardiovascular SOFA between alternative and standard therapy|t-test, 2 sided|||||||0.268
71075624|NCT00386425|141659815|SUPERIORITY_OR_OTHER|||||||0.082||95.0||||p-value is for difference in respiratory SOFA between alternative and standard therapy|t-test, 2 sided|||||||0.082
71075625|NCT00386425|141659815|SUPERIORITY_OR_OTHER|||||||0.367||95.0||||p-value is for difference in renal SOFA between alternative and standard therapy|t-test, 2 sided|||||||0.367
71075626|NCT00386425|141659815|SUPERIORITY_OR_OTHER|||||||0.274||95.0||||p-value is for difference in hematology SOFA between alternative and standard therapy|t-test, 2 sided|||||||0.274
71075627|NCT00386425|141659815|SUPERIORITY_OR_OTHER|||||||0.341||95.0||||p-value is for difference in liver SOFA between alternative and standard therapy|t-test, 2 sided|||||||0.341
71075628|NCT00386425|141659817|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for difference between participants normalizing protein C and not normalizing protein C.|Fisher Exact|||||||<0.0001
71075629|NCT00386425|141659818|SUPERIORITY_OR_OTHER|||||||0.622||95.0||||p-value is for 28-Day Mortality, Dead at Day 28 vs. Alive at Day 28|Pearson's chi-square test|||||||0.622
71075630|NCT00386425|141659818|SUPERIORITY_OR_OTHER|||||||0.815||95.0||||p-value is for Hospital Mortality|Fisher Exact|||||||0.815
71075631|NCT01801241|141659843|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||0.45
71075632|NCT03240406|141659844|SUPERIORITY||Mean Difference (Net)|-0.06||||0.259|TWO_SIDED|95.0|-0.15|0.04||Test of the between arm difference in the global composite at Burst 2, adjusted for the study arm, baseline (Burst 1) global composite, and the randomization stratification factors (baseline sex, age, and years of education)|ANCOVA|ANCOVA of Burst 2 composite adjusted for arm, Burst 1 composite, sex, age, and education. Missing/invalid data were multiply imputed using MICE|Mean Difference of MHD Arm compared to control|||0.04|-0.15|0.259
71075633|NCT03240406|141659845|SUPERIORITY||Mean Difference (Net)|-0.64||||0.001|TWO_SIDED|95.0|-1.02|-0.27||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||-0.27|-1.02|0.001
71075634|NCT03240406|141659846|SUPERIORITY||Mean Difference (Net)|-0.94|||<|0.001|TWO_SIDED|95.0|-1.34|-0.54||Estimated from ANCOVA model adjusted for baseline value, age, sex, and years of education at baseline.|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education.|Mean Difference of MHD Arm vs Comparison Arm|||-0.54|-1.34|<0.001
71075635|NCT03240406|141659847|SUPERIORITY||Mean Difference (Net)|0.24||||0.904|TWO_SIDED|95.0|-3.63|4.11||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||4.11|-3.63|0.904
71075636|NCT03240406|141659848|SUPERIORITY||Mean Difference (Net)|-0.12||||0.721|TWO_SIDED|95.0|-0.76|0.52||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, and education; tocopherol biomarker values additionally adjusted for Burst 1 and Burst 2 levels of HDL, LDL, and triglycerides|ANCOVA|Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education; Burst 1 and Burst 2 levels of HDL, LDL and triglycerides|Mean Difference of MHD Arm vs Comparison Arm|||0.52|-0.76|0.721
71075637|NCT03240406|141659849|SUPERIORITY||Mean Difference (Net)|0.0||||0.769|TWO_SIDED|95.0|-0.01|0.01||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, and education; carotenoid biomarker values additionally adjusted for Burst 1 and Burst 2 levels of HDL, LDL, and triglycerides|ANCOVA|Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education; Burst 1 and Burst 2 levels of HDL, LDL and triglycerides|Mean Difference of MHD Arm vs Comparison Arm|||0.01|-0.01|0.769
71075638|NCT03240406|141659850|SUPERIORITY||Mean Difference (Net)|-1.37||||0.978|TWO_SIDED|95.0|-100.13|97.4||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||97.4|-100.13|0.978
71075639|NCT03240406|141659851|SUPERIORITY||Mean Difference (Net)|0.15||||0.395|TWO_SIDED|95.0|-0.2|0.51||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|Statistical Analysis results for Monounsaturated Fat||0.51|-0.2|0.395
71075640|NCT03240406|141659851|SUPERIORITY||Mean Difference (Net)|-0.11||||0.019|TWO_SIDED|95.0|-0.21|-0.02||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|Statistical Analysis results for Long Chain Saturated Fat||-0.02|-0.21|0.019
70940848|NCT00113880|141381683|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.69||||0.03|TWO_SIDED|95.0|0.5|0.97||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 years, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Any acute resp. tract event rates were presented per 1,000 person-months.||0.97|0.50|0.03
71075641|NCT03240406|141659851|SUPERIORITY||Mean Difference (Net)|0.12||||0.201|TWO_SIDED|95.0|-0.07|0.31||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|Statistical Analysis results for EPA||0.31|-0.07|0.201
70940849|NCT00113880|141381683|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41||||0.01||95.0|0.21|0.79||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 years, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Any acute resp. tract event rates were presented per 1,000 person-months.||0.79|0.21|0.01
70853645|NCT00913458|141195439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.98||||0.0035|TWO_SIDED|95.0|-21.5|-4.5|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-4.5|-21.5|0.0035
70853646|NCT00913458|141195440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.36||||0.2473|TWO_SIDED|95.0|-11.8|3.1|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||3.1|-11.8|0.2473
70853647|NCT00913458|141195440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.19||||0.0016|TWO_SIDED|95.0|-21.3|-5.1|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-5.1|-21.3|0.0016
70853648|NCT00913458|141195440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.83||||0.0348|TWO_SIDED|95.0|-17.0|-0.6|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-0.6|-17.0|0.0348
70853649|NCT00913458|141195441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.51||||0.1248|TWO_SIDED|95.0|-12.6|1.6|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||1.6|-12.6|0.1248
70853650|NCT00913458|141195441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.14||||0.0004|TWO_SIDED|95.0|-21.8|-6.5|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-6.5|-21.8|0.0004
70853651|NCT00913458|141195441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.63||||0.0306|TWO_SIDED|95.0|-16.4|-0.8|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-0.8|-16.4|0.0306
70853652|NCT00913458|141195442|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.4717|TWO_SIDED|95.0|0.5|4.6|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.6|0.5|0.4717
71075642|NCT03240406|141659851|SUPERIORITY||Mean Difference (Net)|0.27||||0.039|TWO_SIDED|95.0|0.01|0.53||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|Statistical Analysis results for DHA||0.53|0.01|0.039
71075643|NCT03240406|141659851|SUPERIORITY||Mean Difference (Net)|-0.01||||0.619|TWO_SIDED|95.0|-0.06|0.03||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean difference of MHD Arm vs Comparison Arm|Statistical Analysis results for n3 DPA||0.03|-0.06|0.619
71075644|NCT03240406|141659852|SUPERIORITY||Mean Difference (Net)|0.18||||0.521|TWO_SIDED|95.0|-0.37|0.73||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.73|-0.37|0.521
71075645|NCT03240406|141659853|SUPERIORITY||Mean Difference (Net)|145.0||||0.101|TWO_SIDED|95.0|-27.7|317.6||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||317.6|-27.7|0.101
70940850|NCT00113880|141381684|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.95||||0.02|TWO_SIDED|95.0|1.14|3.34||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Sinusitis event rates were presented per 1,000 person-months.||3.34|1.14|0.02
71075646|NCT03240406|141659854|SUPERIORITY||Mean Difference (Net)|-24.63||||0.645|TWO_SIDED|95.0|-129.16|79.89||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||79.89|-129.16|0.645
71075647|NCT03240406|141659855|SUPERIORITY||Mean Difference (Net)|3.26||||0.245|TWO_SIDED|95.0|-2.23|8.75||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||8.75|-2.23|0.245
71075648|NCT03240406|141659856|SUPERIORITY||Mean Difference (Net)|0.21||||0.032|TWO_SIDED|95.0|0.02|0.4||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.4|0.02|0.032
71075649|NCT03240406|141659857|SUPERIORITY||Mean Difference (Net)|0.17|||<|0.001|TWO_SIDED|95.0|0.08|0.26||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.26|0.08|<0.001
71075650|NCT03240406|141659858|SUPERIORITY||Mean Difference (Net)|-1.36||||0.635|TWO_SIDED|95.0|-6.95|4.24||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||4.24|-6.95|0.635
71075651|NCT03240406|141659859|SUPERIORITY||Mean Difference (Net)|-3.52||||0.019|TWO_SIDED|95.0|-6.44|0.59||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.59|-6.44|0.019
71075652|NCT03240406|141659860|SUPERIORITY||Mean Difference (Net)|-3.13||||0.639|TWO_SIDED|95.0|-16.18|9.92||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||9.92|-16.18|0.639
71075653|NCT03240406|141659861|SUPERIORITY||Mean Difference (Net)|41.71|||<|0.001|TWO_SIDED|95.0|21.47|61.96||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||61.96|21.47|<0.001
71075654|NCT03240406|141659862|SUPERIORITY||Mean Difference (Net)|-15.37||||0.115|TWO_SIDED|95.0|-34.44|3.69||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||3.69|-34.44|0.115
71075655|NCT03240406|141659863|SUPERIORITY||Mean Difference (Net)|0.06||||0.847|TWO_SIDED|95.0|-0.53|0.64||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.64|-0.53|0.847
71075656|NCT03240406|141659864|SUPERIORITY||Mean Difference (Net)|118.57||||0.191|TWO_SIDED|95.0|-58.62|295.76||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||295.76|-58.62|0.191
71075657|NCT03240406|141659865|SUPERIORITY||Mean Difference (Net)|955.19||||0.019|TWO_SIDED|95.0|164.63|1745.74||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||1745.74|164.63|0.019
71116488|NCT00487942|141739415|SUPERIORITY_OR_OTHER||Effect size|0.33|||||TWO_SIDED|95.0|-0.58|1.24||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.24|-0.58|
71116489|NCT00487942|141739415|SUPERIORITY_OR_OTHER||Effect size|-0.05|||||TWO_SIDED|95.0|-0.91|0.81||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.81|-0.91|
70940851|NCT00113880|141381684|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Exact method or Cox model|||Irritable bowel syndrome event rates were presented per 1,000 person-months. If the control group has no event, the RR or HR is not estimable.||||0.02
70940852|NCT00113880|141381685|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.01|TWO_SIDED|95.0|0.15|0.57||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.57|0.15|0.01
70940853|NCT00113880|141381685|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.03|TWO_SIDED|95.0|0.12|0.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 5-8, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.92|0.12|0.03
70940854|NCT00113880|141381685|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||0.01|TWO_SIDED|95.0|0.13|0.74||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.74|0.13|0.01
70940855|NCT00113880|141381685|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.04|TWO_SIDED|95.0|0.55|0.99||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Pharyngitis event rates were presented per 1,000 person-months.||0.99|0.55|0.04
70940856|NCT00113880|141381685|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36||||0.04|TWO_SIDED|95.0|0.14|0.93||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 years, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Pharyngitis event rates were presented per 1,000 person-months.||0.93|0.14|0.04
71075658|NCT03240406|141659866|SUPERIORITY||Mean Difference (Net)|-15.74||||0.493|TWO_SIDED|95.0|-60.66|29.19||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||29.19|-60.66|0.493
71075659|NCT03240406|141659867|SUPERIORITY||Mean Difference (Net)|14.83||||0.18|TWO_SIDED|95.0|-6.78|36.45||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||36.45|-6.78|0.18
71075660|NCT03240406|141659868|SUPERIORITY||Mean Difference (Net)|436.14||||0.379|TWO_SIDED|95.0|-534.05|1406.33||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||1406.33|-534.05|0.379
71075661|NCT03240406|141659869|SUPERIORITY||Mean Difference (Net)|784.06||||0.083|TWO_SIDED|95.0|-99.73|1667.85||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||1667.85|-99.73|0.083
71075662|NCT03240406|141659870|SUPERIORITY||Mean Difference (Net)|1.33||||0.011|TWO_SIDED|95.0|0.32|2.35||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||2.35|0.32|0.011
71075663|NCT03240406|141659871|SUPERIORITY||Mean Difference (Net)|0.07||||0.541|TWO_SIDED|95.0|-0.16|0.31||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.31|-0.16|0.541
71075664|NCT03240406|141659872|SUPERIORITY||Mean Difference (Net)|0.01||||0.273|TWO_SIDED|95.0|-0.01|0.03||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.03|-0.01|0.273
70853653|NCT00913458|141195442|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.77||||0.0551|TWO_SIDED|95.0|1.0|7.8|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||7.8|1.0|0.0551
71075665|NCT03240406|141659873|SUPERIORITY||Mean Difference (Net)|0.03||||0.116|TWO_SIDED|95.0|-0.01|0.06||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.06|-0.01|0.116
71075666|NCT03240406|141659874|SUPERIORITY||Mean Difference (Net)|0.0||||0.213|TWO_SIDED|95.0|0.0|0.01||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.01|0|0.213
71075667|NCT03240406|141659875|SUPERIORITY||Mean Difference (Net)|0.05||||0.036|TWO_SIDED|95.0|0.0|0.09||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.09|0|0.036
71075668|NCT03240406|141659876|SUPERIORITY||Mean Difference (Net)|0.17||||0.223|TWO_SIDED|95.0|-0.1|0.43||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.43|-0.1|0.223
71075669|NCT03240406|141659877|SUPERIORITY||Mean Difference (Net)|-0.17||||0.119|TWO_SIDED|95.0|-0.38|0.04||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.04|-0.38|0.119
71116490|NCT00487942|141739415|SUPERIORITY_OR_OTHER||Effect size|-0.44|||||TWO_SIDED|95.0|-1.33|0.45||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.45|-1.33|
71116491|NCT00487942|141739416|SUPERIORITY_OR_OTHER||Effect size|0.18|||||TWO_SIDED|95.0|-0.75|1.1||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.10|-0.75|
71116492|NCT00487942|141739416|SUPERIORITY_OR_OTHER||Effect size|-0.1|||||TWO_SIDED|95.0|-0.98|0.78||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.78|-0.98|
71116493|NCT00487942|141739416|SUPERIORITY_OR_OTHER||Effect size|0.37|||||TWO_SIDED|95.0|-0.54|1.27||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.27|-0.54|
71116494|NCT00487942|141739417|SUPERIORITY_OR_OTHER||Effect size|-0.38|||||TWO_SIDED|95.0|-1.14|0.38||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.38|-1.14|
71075670|NCT03240406|141659878|SUPERIORITY||Mean Difference (Net)|-0.04||||0.841|TWO_SIDED|95.0|-0.41|0.33||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.33|-0.41|0.841
70853654|NCT00913458|141195442|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.2141|TWO_SIDED|95.0|0.7|4.8|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.8|0.7|0.2141
71075671|NCT03240406|141659879|SUPERIORITY||Mean Difference (Net)|0.25||||0.088|TWO_SIDED|95.0|-0.04|0.53||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.53|-0.04|0.088
71075672|NCT03240406|141659880|SUPERIORITY||Mean Difference (Net)|-0.01||||0.893|TWO_SIDED|95.0|-0.13|0.11||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.11|-0.13|0.893
71075673|NCT03240406|141659881|SUPERIORITY||Mean Difference (Net)|-1.43||||0.042|TWO_SIDED|95.0|-2.81|-0.06||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||-0.06|-2.81|0.042
71075674|NCT03240406|141659882|SUPERIORITY||Slope|-16.0||||0.031|TWO_SIDED|95.0|-31.0|-1.5||Linear mixed-effects model adjusted for adjusted for arm, year, weekday, season, EMA cognition, baseline age, sex, education yrs, # of sessions (cubic spline), and time of day (cubic spline)|Mixed Models Analysis|Adjusted for arm, year, weekday, season, EMA cognition, baseline age, sex, education yrs, # of sessions (cubic spline), and time of day (cubic spline)|Difference in the slopes of processing speed over years between MHD Arm and Comparison Arm.|||-1.5|-31|0.031
71075675|NCT03240406|141659883|SUPERIORITY||Slope|0.12||||0.55|TWO_SIDED|95.0|-0.27|0.51||Linear mixed-effects model adjusted for arm, year, weekday, season, EMA cognition, baseline age, sex, education yrs, # of sessions (cubic spline), and time of day (cubic spline)|Mixed Models Analysis|Adjusted for arm, year, weekday, season, EMA cognition, baseline age, sex, education yrs, # of sessions (cubic spline), and time of day (cubic spline)|Difference in the slopes of error distance over years between MHD Arm vs Comparison Arm|||0.51|-0.27|0.55
71075676|NCT03240406|141659884|SUPERIORITY||Slope|-0.018||||0.846|TWO_SIDED|95.0|-0.09|0.054||Generalized Estimating equation Poisson model adjusted for arm, year, weekday vs weekend, season, EMA cognition, baseline age, sex, education yrs, # of sessions (cubic spline), time of day (cubic spline)|Generalized Estimating Equation|Adjusted for arm, year, wkday/wknd, season, EMA cognition, baseline age, sex, education yrs, # of sessions (cubic spline), time of day (cubic spline)|Difference in the slopes of log-transformed error rates over years between the MHD Arm and the Comparison Arm.|||0.054|-0.090|0.846
71075677|NCT00207727|141659944|SUPERIORITY_OR_OTHER|||||||0||95.0||||The p-value was non estimable because the observed trend was in the opposite direction of that stated in the one sided alternative hypothesis|Jonckheere Terpstra|Jonckheere Terpstra nonparametric trend test procedure with 5% level of significance was be used to test for the monotonic trend.||Hypothesis: The null hypothesis of no effect among the treatment groups was tested against the alternative hypothesis that the cumulative number of newly Gd-enhancing T1-weighted lesions on cranial MRIs through Week 23 would decrease monotonically with dose at a significance level of 0.05.||||0.00
71116495|NCT00487942|141739417|SUPERIORITY_OR_OTHER||Effect size|-0.13|||||TWO_SIDED|95.0|-0.89|0.63||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.63|-0.89|
71116496|NCT00487942|141739417|SUPERIORITY_OR_OTHER||Effect size|-0.05|||||TWO_SIDED|95.0|-0.84|0.73||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.73|-0.84|
71116497|NCT00487942|141739418|SUPERIORITY_OR_OTHER||Effect size|-0.41|||||TWO_SIDED|95.0|-1.21|0.4||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.40|-1.21|
71116498|NCT00487942|141739418|SUPERIORITY_OR_OTHER||Effect size|-0.29|||||TWO_SIDED|95.0|-1.09|0.52||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.52|-1.09|
70940857|NCT00113880|141381685|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.02|TWO_SIDED|95.0|0.71|0.97||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any acute respiratory tract event rates were presented per 1,000 person-months.||0.97|0.71|0.02
70940858|NCT00113880|141381685|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.01|TWO_SIDED|95.0|0.57|0.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any acute respiratory tract event rates were presented per 1,000 person-months.||0.92|0.57|0.01
70940859|NCT00113880|141381685|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36||||0.01|TWO_SIDED|95.0|0.22|0.61||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.61|0.22|0.01
70940860|NCT00113880|141381685|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.01|TWO_SIDED|95.0|0.16|0.68||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.68|0.16|0.01
70940861|NCT00113880|141381685|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.0||||0.03|TWO_SIDED|95.0|0.0|0.82|||Fisher Exact||Population: 18-49, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.82|0.00|0.03
70940862|NCT00113880|141381686|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.01|TWO_SIDED|95.0|0.58|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.91|0.58|0.01
70940863|NCT00113880|141381686|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.01|TWO_SIDED|95.0|0.49|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.91|0.49|0.01
70940864|NCT00113880|141381686|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.01|TWO_SIDED|95.0|0.61|0.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.92|0.61|0.01
71075678|NCT00207727|141659945|SUPERIORITY_OR_OTHER|||||||0.892||95.0|||||2-sided Wilcoxon Mann-Whitney|||||||0.892
71075679|NCT00207727|141659945|SUPERIORITY_OR_OTHER|||||||0.599||95.0|||||2-sided Wilcoxon Mann-Whitney|||||||0.599
71075680|NCT00207727|141659945|SUPERIORITY_OR_OTHER|||||||0.517||95.0|||||2-sided Wilcoxon Mann-Whitney|||||||0.517
71075681|NCT00207727|141659945|SUPERIORITY_OR_OTHER|||||||0.967||95.0|||||2-sided Wilcoxon Mann-Whitney|||Hypothesis: The null hypothesis is no difference between any ustekinumab treatment groups and placebo at a significant level of 0.05 for comparison for each treatment group.||||0.967
71075682|NCT00207727|141659946|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||Wilcoxon (Mann-Whitney)|2-sided Wilcoxon Mann-Whitney test (α = 0.05) used for each comparison with placebo||||||0.720
71075683|NCT00207727|141659946|SUPERIORITY_OR_OTHER|||||||0.152||95.0|||||Wilcoxon (Mann-Whitney)|2-sided Wilcoxon Mann-Whitney test (α = 0.05) used for each comparison with placebo||||||0.152
71075684|NCT00207727|141659946|SUPERIORITY_OR_OTHER|||||||0.431||95.0|||||Wilcoxon (Mann-Whitney)|2-sided Wilcoxon Mann-Whitney test (α = 0.05) used for each comparison with placebo||||||0.431
71075685|NCT00207727|141659946|SUPERIORITY_OR_OTHER|||||||0.292||95.0|||||Wilcoxon (Mann-Whitney)|2-sided Wilcoxon Mann-Whitney test (α = 0.05) used for each comparison with placebo||Hypothesis: The null hypothesis is no difference between any ustekinumab treatment groups and placebo at a significant level of 0.05 for comparison for each treatment group with placebo..||||0.292
71075686|NCT00435019|141659959|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis for the non-inferiority test was that the mean HbA1c with insulin detemir was greater than or equal to the mean HbA1c with NPH insulin plus 0.4%. A sample size of 344 subjects, in total, with a drop-out rate of 20 percent would yield 274 subjects for evaluation of HbA1c. This would give 85 percent power to detect a difference in means of HbA1c of 0.4 percentage points assuming that the standard deviation was 1.1 using a two-sided t-test with a 0.05 significance level.|Mean Difference (Final Values)|0.12||||||95.0|-0.12|0.36|||ANCOVA|||||0.36|-0.12|
71075687|NCT02669082|141659972|OTHER|||||||0.2955|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.2955
70940865|NCT00113880|141381686|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.01|TWO_SIDED|95.0|0.52|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.91|0.52|0.01
71075688|NCT02669082|141659973|OTHER|||||||0.1358|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.1358
71075689|NCT02669082|141659974|OTHER||Median|||||0.1706|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.1706
71075690|NCT02669082|141659975|OTHER|||||||0.1969|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.1969
71075691|NCT02669082|141659976|OTHER|||||||0.0534|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.0534
71075692|NCT02669082|141659977|OTHER|||||||0.4125|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.4125
71075693|NCT02669082|141659978|OTHER|||||||0.022|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.0220
71075694|NCT02669082|141659979|OTHER|||||||0.042|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.0420
71075695|NCT02669082|141659980|OTHER|||||||0.8166|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.8166
71075696|NCT02380859|141660004|SUPERIORITY|||||||0.005|||||||ANOVA|||Group (real, sham) x Time (pre, 1d post) x Stepping Direction (forward, backward) ANOVA||||0.005
71075697|NCT02284568|141660018|SUPERIORITY||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.1293||0.903|TWO_SIDED|95.0|-0.239|0.2705||significance at 0.05.|Repeated Measures ANCOVA|||The statistical model was a repeated measures analysis of covariance with treatment group, week, treatment group by week interaction, normalized brain volume at baseline, natural logarithm of T2 lesion volume at baseline, and country as fixed effects.||0.2705|-0.2390|0.903
70940866|NCT00113880|141381687|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41||||0.01|TWO_SIDED|95.0|0.33|0.51||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.51|0.33|0.01
70940867|NCT00113880|141381687|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.37||||0.01|TWO_SIDED|95.0|0.26|0.55||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 5-8 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.55|0.26|0.01
70940868|NCT00113880|141381687|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.42||||0.01|TWO_SIDED|95.0|0.31|0.56||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.56|0.31|0.01
70940869|NCT00113880|141381687|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29||||0.02|TWO_SIDED|95.0|0.26|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.91|0.26|0.02
70940870|NCT00113880|141381687|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45||||0.01||95.0|0.37|0.55||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.55|0.37|0.01
71075698|NCT02284568|141660020|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.426|TWO_SIDED|95.0|0.48|1.37||significance at 0.05. p-value was from a log-rank test, and estimate and confidence limits were from a Cox model with treatment group as fixed effect, due to the violation of the proportionality assumption.|Log Rank||Laquinimod 0.6 mg vs placebo|The statistical model was a Cox proportional hazards regression model with treatment group, categorical EDSS at baseline (≤4.5 or \>4.5), age at baseline, natural logarithm of T2 lesion volume at baseline, and country as fixed effects.||1.37|0.48|0.426
71075699|NCT02284568|141660021|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.867|TWO_SIDED|95.0|0.68|1.59||significance at 0.05.|Regression, Cox||Laquinimod 0.6 mg vs placebo|The statistical model was a Cox proportional hazards regression model with treatment group, categorical EDSS at baseline (≤4.5 or \>4.5), age at baseline, natural logarithm of T2 lesion volume at baseline, and country as fixed effects.||1.59|0.68|0.867
71075700|NCT02284568|141660022|SUPERIORITY||Mean Difference (Final Values)|-0.325|STANDARD_ERROR_OF_MEAN|0.2679||0.248|TWO_SIDED|95.0|-0.85|0.2||significance at 0.05. The p-value for ranked change from baseline values was from a repeated measures analysis of covariance with trt group, week, treatment group by week interaction, rank of T25FW score at baseline, and country as fixed effects.|Repeated Measures ANCOVA||Laquinimod 0.6 mg vs. placebo treatment effect|placebo n=121 Laquinimod 0.6 mg n=108 The estimate of parameter, standard error, and 95% confidence intervals for change from baseline was from a Mann-Whitney-Wilcoxon Test using Hodges-Lehmann estimates.||0.2000|-0.8500|0.248
71075701|NCT02284568|141660023|SUPERIORITY||Risk Ratio (RR)|0.4|STANDARD_ERROR_OF_MEAN|0.11||0.001|TWO_SIDED|95.0|0.26|0.69||significance at 0.05|negative binomial regression model||Laquinimod 0.6 mg vs. placebo risk ratio|This analysis was performed using baseline adjusted negative binomial regression model (SAS® PROC GENMOD) in which 1 contrast for comparing laquinimod 0.6 mg to placebo was constructed. In addition to the treatment group, the natural logarithm of T2 lesion volume at baseline, age at baseline and country/geographical region (CGR) were used as covariates.||0.69|0.26|0.001
71075702|NCT03114657|141660029|SUPERIORITY||Least Squares Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.633|||TWO_SIDED|95.0|0.0|2.6||||||||2.60|0.00|
71075703|NCT03114657|141660030|SUPERIORITY||Least Squares Mean Difference|1.74|STANDARD_ERROR_OF_MEAN|2.028|||TWO_SIDED|95.0|-2.4|5.89||||||||5.89|-2.40|
71075704|NCT03114657|141660031|SUPERIORITY||Least Squares Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|2.124|||TWO_SIDED|95.0|-4.03|4.68||||||||4.68|-4.03|
71116499|NCT00487942|141739418|SUPERIORITY_OR_OTHER||Effect size|-0.69|||||TWO_SIDED|95.0|-1.51|0.14||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.14|-1.51|
71075705|NCT03114657|141660032|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|95.0|-0.2|0.39||||||||0.39|-0.20|
71075706|NCT03114657|141660033|SUPERIORITY||Least Squares Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.985|||TWO_SIDED|95.0|-2.42|1.6||||||||1.60|-2.42|
71075707|NCT03114657|141660034|SUPERIORITY||Least Squares Mean Difference|-2.52|STANDARD_ERROR_OF_MEAN|3.052|||TWO_SIDED|95.0|-8.74|3.7||||||||3.70|-8.74|
71075708|NCT03114657|141660035|SUPERIORITY||Least Squares Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|2.501|||TWO_SIDED|95.0|-6.29|3.92||||||||3.92|-6.29|
71075709|NCT03114657|141660036|SUPERIORITY||Least Squares Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|1.42|||TWO_SIDED|95.0|-2.25|3.51||||||||3.51|-2.25|
71075710|NCT03114657|141660038|SUPERIORITY||Least Squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.502|||TWO_SIDED|95.0|-1.75|0.23||||||||0.23|-1.75|
71075711|NCT03114657|141660039|SUPERIORITY||Least Squares Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|1.383|||TWO_SIDED|95.0|-3.3|2.39||||||||2.39|-3.30|
71075712|NCT03114657|141660040|SUPERIORITY||Least Squares Mean Difference|6.55|STANDARD_ERROR_OF_MEAN|5.527|||TWO_SIDED|95.0|-4.35|17.44||||||||17.44|-4.35|
71075713|NCT03114657|141660041|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|5.831|||TWO_SIDED|95.0|-12.31|11.71||||||||11.71|-12.31|
71075714|NCT03114657|141660042|SUPERIORITY||Least Squares Mean Difference|-3.38|STANDARD_ERROR_OF_MEAN|3.94|||TWO_SIDED|95.0|-11.5|4.73||||||||4.73|-11.50|
71075715|NCT03114657|141660048|SUPERIORITY||Least Squares Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.622|||TWO_SIDED|95.0|-2.01|0.89||||||||0.89|-2.01|
71075716|NCT03114657|141660049|SUPERIORITY||Least Squares Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|1.668|||TWO_SIDED|95.0|-1.7|4.9||||||||4.90|-1.70|
71075717|NCT03114657|141660050|SUPERIORITY||Least Squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.373|||TWO_SIDED|95.0|-1.13|0.41||||||||0.41|-1.13|
71075718|NCT01546038|141660053|OTHER||Hazard Ratio (HR)|0.569||||0.002|TWO_SIDED|80.0|0.441|0.734||1-sided p-value from the log-rank test stratified by prognosis stratum according to Interactive Voice Response System (IVRS).|Log Rank||Based on the Cox proportional hazards model stratified by prognosis stratum according to IVRS.|||0.734|0.441|0.0020
71075719|NCT01546038|141660057|OTHER||Odds Ratio (OR)|4.2755||||0.0112|TWO_SIDED|80.0|1.3057|13.9994|||Cochran-Mantel-Haenszel||Based on the Cox proportional hazards model stratified by prognosis stratum according to IVRS.|||13.9994|1.3057|0.0112
71075720|NCT00987402|141660132|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||generalized estimating equation|||Power calculations assumed a 2-sided alpha error of 0.05 and a power of 80%. We performed power calculations using a statistical model for a cluster-randomized trial with 8, 10 or 12 clusters including 6 operating rooms each, with different levels of reduction (10%, 30%, 50%) in surgical site infection rates in the active intervention period. By reaching a sample size of 3133 patients, the study was powered to detect a 30% reduction effect in SSI rates, from 10% to 7%.||||<0.05
71075721|NCT00236899|141660146|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.345||95.0|0.87|1.5|||Regression, Cox|||||1.50|0.87|0.345
71075722|NCT00236899|141660147|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.885|TWO_SIDED|95.0|0.69|1.37|||Regression, Cox|||||1.37|0.69|0.885
71075723|NCT00236899|141660148|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.976|TWO_SIDED|95.0|0.71|1.42|||Regression, Cox|||||1.42|0.71|0.976
71075724|NCT00236899|141660149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.442||||0.0028|TWO_SIDED|95.0|0.259|0.754|||Regression, Logistic|||||0.754|0.259|0.0028
71075725|NCT00236899|141660150|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.15|TWO_SIDED|95.0|0.93|1.62|||Regression, Cox|||||1.62|0.93|0.150
71075726|NCT00236899|141660151|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.818||||0.4567|TWO_SIDED|95.0|0.482|1.389|||Regression, Logistic|||||1.389|0.482|0.4567
71075727|NCT00236899|141660153|SUPERIORITY_OR_OTHER|||||||0.142||95.0||||This is the p-value for Treatment Schedule (Docetaxel and Gemcitabine 3 Weekly + Paclitaxel and Gemcitabine 3 Weekly) and Treatment Drug (Docetaxel and Gemcitabine Weekly + Paclitaxel and Gemcitabine Weekly).|Fisher Exact|||||||0.142
71075728|NCT00236899|141660153|SUPERIORITY_OR_OTHER|||||||0.47||95.0||||This is the p-value for Treatment Drug (Docetaxel and Gemcitabine 3 Weekly + Docetaxel and Gemcitabine Weekly vs Paclitaxel and Gemcitabine 3 Weekly + Paclitaxel and Gemcitabine Weekly).|Fisher Exact|||||||0.470
71075729|NCT00236899|141660154|SUPERIORITY_OR_OTHER|||||||0.293||95.0||||This is the p-value for Treatment Schedule (Docetaxel and Gemcitabine 3 Weekly + Paclitaxel and Gemcitabine 3 Weekly) and Treatment Drug (Docetaxel and Gemcitabine Weekly + Paclitaxel and Gemcitabine Weekly).|Fisher Exact|||||||0.293
71075730|NCT00236899|141660154|SUPERIORITY_OR_OTHER|||||||0.476||95.0||||This is the p-value for Treatment Drug (Docetaxel and Gemcitabine 3 Weekly + Docetaxel and Gemcitabine Weekly vs Paclitaxel and Gemcitabine 3 Weekly + Paclitaxel and Gemcitabine Weekly).|Fisher Exact|||||||0.476
71075731|NCT03379792|141660157|OTHER|||||||0.24|||||||t-test, 2 sided|||||||0.24
71075732|NCT03379792|141660157|OTHER|||||||0.22|||||||t-test, 2 sided|||||||0.22
71075733|NCT03379792|141660157|OTHER|||||||1|||||||t-test, 2 sided|||||||1.0
71075734|NCT03924505|141660176|SUPERIORITY||Incidence Rate Ratio|2.15|||<|0.01|TWO_SIDED|95.0|1.42|2.35||A priori threshold for statistical significance set at p\<0.05|Negative Binomial Regression|We adjusted for baseline rate due to baseline differences.|The incidence rate ratio estimates the effect of facilitation for implementation effectiveness and dissemination of best practice recommendations, as compared to dissemination of best practice recommendations.|||2.35|1.42|<0.01
71075735|NCT03924505|141660177|SUPERIORITY||Incidence Rate Ratio|1.97||||0.01|TWO_SIDED|95.0|1.18|3.3||A priori threshold for statistical signicance is p\<0.05|Negative Binomial Regression||The incidence rate ratio estimates the effect of facilitation for implementation effectiveness and dissemination of best practice recommendations, as compared to dissemination of best practice recommendations.|||3.30|1.18|0.01
71075736|NCT03924505|141660178|OTHER|Testing for differences in means|Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.4||0.68|TWO_SIDED|95.0|-0.7|1.0|||t-test, 2 sided|||||1.0|-0.7|0.68
71075737|NCT00568334|141660182|NON_INFERIORITY|The lower limit (LL) of the 95% confidence interval (CI) for the GMT ratio (derived from IFA) between Group Varilrix HSA-Free and (divided by) Group Varilrix is equal to or above (≥) the pre-defined clinical limit of 0.5.|GMT Ratio|1.12|||||TWO_SIDED|95.0|0.86|1.46|||ANOVA|||Non-inferiority of Varilrix™ HSA-Free vaccine as compared to Varilrix™ vaccine in terms of geometric mean titers (GMTs) of varicella zoster virus (VZV) antibodies 43-57 days after the first vaccine dose.||1.46|0.86|
71075738|NCT00568334|141660183|NON_INFERIORITY|The lower limit (LL) of the 95% confidence interval (CI) for the GMC ratio (derived from ELISA) between Group Varilrix HSA-Free and (divided by) Group Varilrix is equal to or above (≥) the pre-defined clinical limit of 0.67.|GMC Ratio|1.12|||||TWO_SIDED|95.0|0.93|1.33|||ANOVA|||Non-inferiority of Varilrix™ HSA-Free vaccine as compared to Varilrix™ vaccine in terms of geometric mean concentrations (GMCs) of varicella zoster virus (VZV) antibodies 43-57 days after the first vaccine dose.||1.33|0.93|
71075739|NCT02273908|141660226|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.949|||<|0.001|TWO_SIDED|95.0|-1.459|-0.439|||Mixed Models Analysis|||||-0.439|-1.459|<0.001
71075740|NCT02273908|141660227|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.259|||<|0.001|TWO_SIDED|95.0|-3.131|-1.387|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 8.||-1.387|-3.131|<0.001
71075741|NCT02273908|141660227|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.887|||<|0.001|TWO_SIDED|95.0|-2.704|-1.071|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 4.||-1.071|-2.704|<0.001
71075742|NCT02273908|141660228|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.3018|||<|0.001|TWO_SIDED|95.0|1.4903|5.1133|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 8.||5.1133|1.4903|<0.001
71075743|NCT02273908|141660228|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|2.729||||0.004|TWO_SIDED|95.0|0.9047|4.5533|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 4.||4.5533|0.9047|0.004
71075744|NCT02273908|141660229|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.83|||<|0.001|TWO_SIDED|95.0|-1.301|-0.359|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 8.||-0.359|-1.301|<0.001
71075745|NCT02273908|141660229|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.674||||0.004|TWO_SIDED|95.0|-1.125|-0.223|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 4.||-0.223|-1.125|0.004
71075746|NCT02273908|141660230|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0204||||0.175|TWO_SIDED|95.0|-0.0091|0.0499|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 8.||0.0499|-0.0091|0.175
70853655|NCT00913458|141195444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9652|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|P-values for between-treatment comparisons are based on ANCOVA on ranks of change in score with ranks of Week 52 value as covariate.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||0.4|-0.5|0.9652
71075747|NCT02273908|141660230|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0329||||0.017|TWO_SIDED|95.0|0.0058|0.06|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 4.||0.0600|0.0058|0.017
71075748|NCT02273908|141660231|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.697||||0.026|TWO_SIDED|95.0|0.552|8.842|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 8.||8.842|0.552|0.026
71075749|NCT02273908|141660231|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.292||||0.477|TWO_SIDED|95.0|-2.282|4.866|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 4.||4.866|-2.282|0.477
71075750|NCT02273908|141660232|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Modified Chi-squared|||||||<0.001
70853656|NCT00913458|141195444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.2168|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|P-values for between-treatment comparisons are based on ANCOVA on ranks of change in score with ranks of Week 52 value as covariate.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||0.0|-1.0|0.2168
70853657|NCT00913458|141195444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.2131|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|P-values for between-treatment comparisons are based on ANCOVA on ranks of change in score with ranks of Week 52 value as covariate.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||0.0|-1.0|0.2131
70853658|NCT00913458|141195446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.9338|TWO_SIDED|95.0|-10.0|10.9|||ANCOVA||Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.|Change from Week 52 to Week 91. The hyothesis of primary interest was the superiority of E25+MTX compared with PBO.||10.9|-10.0|0.9338
70853659|NCT00913458|141195446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.55||||0.713|TWO_SIDED|95.0|-16.4|11.2|||ANCOVA|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||11.2|-16.4|0.7130
71075751|NCT02273908|141660233|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Modified Chi-squared|||||||<0.001
71075752|NCT04908475|141660236|SUPERIORITY||Adjusted Difference|50.7|||<|0.001|TWO_SIDED|95.0|41.3|60.1||Adjusted for strata (baseline body weight \[≤ 100 kg, \> 100 kg\] and prior exposure to any systemic and/or biologic treatment for psoriasis \[0, ≥ 1\]) for the comparison of 2 treatment groups.|Cochran-Mantel-Haenszel|||||60.1|41.3|< 0.001
71075753|NCT04908475|141660237|SUPERIORITY||Adjusted Difference|56.8|||<|0.001|TWO_SIDED|95.0|47.7|66.0||Adjusted for strata (baseline body weight \[≤ 100 kg, \> 100 kg\] and prior exposure to any systemic and/or biologic treatment for psoriasis \[0, ≥ 1\]) for the comparison of 2 treatment groups.|Cochran-Mantel-Haenszel|||||66.0|47.7|< 0.001
71075754|NCT04908475|141660238|SUPERIORITY||Difference|69.7|||<|0.001|TWO_SIDED|95.0|59.5|80.0|||Chi-squared|||||80.0|59.5|< 0.001
71075755|NCT04908475|141660239|SUPERIORITY||Adjusted Difference|65.9|||<|0.001|TWO_SIDED|95.0|57.6|73.9||Adjusted for strata (baseline body weight \[≤ 100 kg, \> 100 kg\] and prior exposure to any systemic and/or biologic treatment for psoriasis \[0, ≥ 1\] for the comparison of 2 treatment groups.|Cochran-Mantel-Haenszel|||||73.9|57.6|< 0.001
71075756|NCT04908475|141660240|SUPERIORITY||Difference|71.6|||<|0.001|TWO_SIDED|95.0|60.9|82.3|||Chi-squared|||||82.3|60.9|< 0.001
71075757|NCT04908475|141660241|SUPERIORITY||Difference|69.4|||<|0.001|TWO_SIDED|95.0|58.6|80.2|||Chi-squared|||||80.2|58.6|< 0.001
71075758|NCT01593254|141660288|SUPERIORITY|||||||0.005|||||||Cochran-Mantel-Haenszel|||||||0.005
71075759|NCT00076999|141660310|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.02
71075760|NCT00076999|141660310|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.78
71075761|NCT00076999|141660311|SUPERIORITY_OR_OTHER|||||||0||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.00
71075762|NCT00076999|141660311|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
71075763|NCT00076999|141660312|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.12
71075764|NCT00076999|141660312|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
71075765|NCT00076999|141660313|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.12
71075766|NCT00076999|141660313|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
71075767|NCT00076999|141660314|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.01
71075768|NCT00076999|141660314|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
71075769|NCT00076999|141660315|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.06
71075770|NCT00076999|141660315|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
71075771|NCT00076999|141660316|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.60
71075772|NCT00076999|141660316|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
71075773|NCT00076999|141660317|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.20
71075774|NCT00076999|141660317|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
71075775|NCT00076999|141660318|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.18
71075776|NCT00076999|141660318|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
71075777|NCT00076999|141660320|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.02
71075778|NCT00076999|141660320|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.47
71075779|NCT00076999|141660321|SUPERIORITY_OR_OTHER|||||||0||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.00
71075780|NCT00076999|141660321|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.81
71075781|NCT00076999|141660322|SUPERIORITY_OR_OTHER|||||||0||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.00
71075782|NCT00076999|141660322|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.69
71075783|NCT00076999|141660324|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.64
71075784|NCT00076999|141660324|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.26
71075785|NCT00076999|141660325|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.25
71075786|NCT00076999|141660325|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.70
71075787|NCT00076999|141660326|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.73
71075788|NCT00076999|141660326|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.79
71075789|NCT00076999|141660328|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.38
71075790|NCT00076999|141660328|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.20
71075791|NCT00076999|141660329|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.08
71075792|NCT00076999|141660329|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.36
71075793|NCT00076999|141660330|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.23
71075794|NCT00076999|141660330|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.23
71075795|NCT04964986|141660338|SUPERIORITY|||||||0.041|||||||paired t-test|||||||0.041
71075796|NCT04964986|141660340|SUPERIORITY||||||<|0.001|||||||paired t-test|||Week 24||||<0.001
71075797|NCT04964986|141660340|SUPERIORITY||||||<|0.001|||||||paired t-test|||Week 52||||<0.001
71075798|NCT04964986|141660344|SUPERIORITY|||||||0.002|||||||paired t-test|||Week 24||||0.002
71075799|NCT04964986|141660344|SUPERIORITY||||||<|0.001|||||||paired t-test|||Week 52||||<0.001
71075800|NCT04964986|141660346|SUPERIORITY|||||||0.294|||||||paired t-test|||Fat absorption increase at Week 4||||0.294
71075801|NCT04964986|141660346|SUPERIORITY|||||||0.155|||||||paired t-test|||Fat absorption increase at Week 48||||0.155
71075802|NCT04964986|141660346|SUPERIORITY|||||||0.26|||||||paired t-test|||Carbohydrate absorption at Week 4||||0.260
71075803|NCT04964986|141660346|SUPERIORITY|||||||0.024|||||||paired t-test|||Carbohydrate absorption at Week 48||||0.024
71075804|NCT04964986|141660346|SUPERIORITY|||||||0.096|||||||paired t-test|||Protein absorption at Week 4||||0.096
71075805|NCT04964986|141660346|SUPERIORITY|||||||0.075|||||||paired t-test|||Protein absorption at Week 48||||0.075
71075806|NCT04964986|141660347|SUPERIORITY|||||||0.063|||||||paired t-test|||Week 4||||0.063
71075807|NCT04964986|141660347|SUPERIORITY|||||||0.112|||||||paired t-test|||Week 48||||0.112
71075808|NCT04964986|141660348|SUPERIORITY|||||||0.306|||||||paired t-test|||||||0.306
71075809|NCT04964986|141660349|SUPERIORITY||Median Difference (Final Values)|0.3346||||0.704|TWO_SIDED|95.0|-0.7887|0.8748|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Calcium, Week 4||0.8748|-0.7887|0.704
70853660|NCT00913458|141195446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.99||||0.6628|TWO_SIDED|95.0|-16.6|10.6|||ANCOVA|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||10.6|-16.6|0.6628
71116500|NCT00487942|141739419|SUPERIORITY_OR_OTHER||Effect size|-0.24|||||TWO_SIDED|95.0|-1.06|0.58||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.58|-1.06|
71116501|NCT00487942|141739419|SUPERIORITY_OR_OTHER||Effect size|-0.05|||||TWO_SIDED|95.0|-0.85|0.75||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.75|-0.85|
71116502|NCT00487942|141739419|SUPERIORITY_OR_OTHER||Effect size|-0.1|||||TWO_SIDED|95.0|-0.9|0.7||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.70|-0.90|
71116503|NCT00487942|141739422|SUPERIORITY_OR_OTHER||Effect size|-0.05|||||TWO_SIDED|95.0|-0.8|0.71||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SANS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.71|-0.80|
71116504|NCT00487942|141739422|SUPERIORITY_OR_OTHER||Effect size|-0.31|||||TWO_SIDED|95.0|-1.06|0.45||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SANS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.45|-1.06|
71116505|NCT00487942|141739422|SUPERIORITY_OR_OTHER||Effect size|0.11|||||TWO_SIDED|95.0|-0.68|0.89||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SANS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.89|-0.68|
71116506|NCT00487942|141739423|SUPERIORITY_OR_OTHER||Effect size|-0.13|||||TWO_SIDED|95.0|-0.88|0.63||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.63|-0.88|
71116507|NCT00487942|141739423|SUPERIORITY_OR_OTHER||Effect size|0.05|||||TWO_SIDED|95.0|-0.72|0.82||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.82|-0.72|
71116508|NCT00487942|141739423|SUPERIORITY_OR_OTHER||Effect size|0.0|||||TWO_SIDED|95.0|-0.8|0.81||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.81|-0.80|
71116509|NCT00487942|141739424|SUPERIORITY_OR_OTHER||Effect size|-0.62|||||TWO_SIDED|95.0|-1.44|0.2||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.20|-1.44|
71116510|NCT00487942|141739424|SUPERIORITY_OR_OTHER||Effect size|-0.18|||||TWO_SIDED|95.0|-0.98|0.62||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.62|-0.98|
70940871|NCT00113880|141381687|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49||||0.01|TWO_SIDED|95.0|0.35|0.67||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 5-8 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.67|0.35|0.01
71075810|NCT04964986|141660349|SUPERIORITY||Median Difference (Final Values)|-0.104||||0.488|TWO_SIDED|95.0|-2.7442|0.8896|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Calcium, Week 48||0.8896|-2.7442|0.488
71075811|NCT04964986|141660349|SUPERIORITY||Median Difference (Final Values)|-0.219||||0.382|TWO_SIDED|95.0|-0.896|0.313|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Magnesium, Week 4||0.313|-0.896|0.382
71075812|NCT04964986|141660349|SUPERIORITY||Median Difference (Final Values)|-1.566||||0.059|TWO_SIDED|95.0|-5.279|-0.165|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Magnesium, Week 48||-0.165|-5.279|0.059
71116511|NCT00487942|141739424|SUPERIORITY_OR_OTHER||Effect size|-0.17|||||TWO_SIDED|95.0|-0.97|0.63||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.63|-0.97|
71116512|NCT00487942|141739425|SUPERIORITY_OR_OTHER||Effect size|-0.08|||||TWO_SIDED|95.0|-0.88|0.72||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.72|-0.88|
71116513|NCT00487942|141739425|SUPERIORITY_OR_OTHER||Effect size|-0.08|||||TWO_SIDED|95.0|-0.88|0.72||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.72|-0.88|
71116514|NCT00487942|141739425|SUPERIORITY_OR_OTHER||Effect size|0.08|||||TWO_SIDED|95.0|-0.72|0.89||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.89|-0.72|
71116515|NCT00487942|141739426|SUPERIORITY_OR_OTHER||Effect size|0.11|||||TWO_SIDED|95.0|-0.65|0.87||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Negative Scale score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.87|-0.65|
71116516|NCT00487942|141739426|SUPERIORITY_OR_OTHER||Effect size|0.13|||||TWO_SIDED|95.0|-0.63|0.88||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Negative Scale score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.88|-0.63|
71116517|NCT00487942|141739426|SUPERIORITY_OR_OTHER||Effect size|1.69|||||TWO_SIDED|95.0|0.78|2.6||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Negative Scale score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||2.60|0.78|
71116518|NCT00487942|141739427|SUPERIORITY_OR_OTHER||Effect size|-0.3|||||TWO_SIDED|95.0|-1.06|0.46||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.46|-1.06|
71075813|NCT04964986|141660349|SUPERIORITY||Median Difference (Final Values)|33.116||||0.004|TWO_SIDED|95.0|5.51|51.861|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Sodium, Week 4||51.861|5.510|0.004
71075814|NCT04964986|141660349|SUPERIORITY||Median Difference (Final Values)|20.727||||0.337|TWO_SIDED|95.0|-27.758|55.828|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Sodium, Week 48||55.828|-27.758|0.337
71075815|NCT04964986|141660349|SUPERIORITY||Median Difference (Final Values)|1.618||||0.724|TWO_SIDED|95.0|-11.87|14.931|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Potassium, Week 4||14.931|-11.870|0.724
70940872|NCT00113880|141381687|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43||||0.01|TWO_SIDED|95.0|0.33|0.56||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.56|0.33|0.01
71075816|NCT04964986|141660349|SUPERIORITY||Median Difference (Final Values)|-9.19||||0.115|TWO_SIDED|95.0|-18.88|3.737|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Potassium, Week 48||3.737|-18.880|0.115
71075817|NCT04964986|141660349|SUPERIORITY||Median Difference (Final Values)|12.297||||0.707|TWO_SIDED|95.0|-39.551|52.617|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Urea, Week 4||52.617|-39.551|0.707
71075818|NCT04964986|141660349|SUPERIORITY||Mean Difference (Final Values)|-91.487||||0.009|TWO_SIDED|95.0|-159.956|-20.068|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Urea, Week 48||-20.068|-159.956|0.009
71075819|NCT04964986|141660349|SUPERIORITY||Median Difference (Final Values)|0.281||||0.572|TWO_SIDED|95.0|-0.649|0.96|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Creatinine, Week 4||0.960|-0.649|0.572
71075820|NCT04964986|141660349|SUPERIORITY||Median Difference (Final Values)|-0.136||||0.981|TWO_SIDED|95.0|-1.06|1.073|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Creatinine, Week 48||1.073|-1.060|0.981
71075821|NCT04964986|141660350|SUPERIORITY|||||||0.066|||||||paired t-test|||Week 24||||0.066
71075822|NCT04964986|141660350|SUPERIORITY|||||||0.015|||||||paired t-test|||Week 52||||0.015
71075823|NCT05821296|141660359|OTHER|Change of sum of total lesions at the end of the study from baseline/Day 0 to evaluate the efficacy and clinical performance of Crystal Peel for the treatment of acne.|Mean Difference (Final Values)|-14.58|STANDARD_ERROR_OF_MEAN|1.38|<|0.0001|TWO_SIDED|95.0|-17.31|-11.84|||ANCOVA|||||-11.84|-17.31|<0.0001
71075824|NCT05821296|141660360|OTHER||Mean Difference (Final Values)|1.85|STANDARD_DEVIATION|0.87|||TWO_SIDED|95.0|1.54|2.16||||||||2.16|1.54|
71075825|NCT05821296|141660361|OTHER||Mean Difference (Final Values)|1.82|STANDARD_DEVIATION|1.07|||TWO_SIDED|95.0|1.44|2.2||||||||2.20|1.44|
71075826|NCT05821296|141660362|OTHER||Mean value in local tolerance score|2.21|STANDARD_DEVIATION|0.65|||TWO_SIDED|95.0|1.98|2.44||||||||2.44|1.98|
71075827|NCT05821296|141660363|OTHER|Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.|% of patients with positive answers|79.0|||||TWO_SIDED|95.0|61.0|89.0||||||||89|61|
71075828|NCT05821296|141660363|OTHER||% of patients with positive answers|94.0|||||TWO_SIDED|95.0|80.0|98.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||98|80|
71075829|NCT05821296|141660363|OTHER||% of patients with positive answers|88.0|||||TWO_SIDED|95.0|73.0|95.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||95|73|
71075830|NCT05821296|141660363|OTHER||% of patients with positive answers|85.0|||||TWO_SIDED|95.0|68.0|93.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||93|68|
71075831|NCT05821296|141660363|OTHER||% of patients with positive answers|91.0|||||TWO_SIDED|95.0|77.0|97.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||97|77|
71075832|NCT05821296|141660363|OTHER||% of patients with positive answers|85.0|||||TWO_SIDED|95.0|69.0|93.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||93|69|
71075833|NCT05821296|141660363|OTHER||% of patients with positive answers|78.0|||||TWO_SIDED|95.0|61.0|89.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||89|61|
71075834|NCT05821296|141660363|OTHER||% of patients with positive answers|79.0|||||TWO_SIDED|95.0|62.0|89.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||89|62|
71075835|NCT05821296|141660363|OTHER||% of patients with positive answers|76.0|||||TWO_SIDED|95.0|59.0|87.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||87|59|
71075836|NCT05821296|141660365|OTHER||Mean Difference (Net)|-47.24|STANDARD_DEVIATION|56.61|<|0.0001|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous number of detected pores at day 15 to evaluate the improvement of pores assessed by Colorface device.||||< 0.0001
71075837|NCT05821296|141660365|OTHER||Mean Difference (Final Values)|-30.85|STANDARD_DEVIATION|63.92||0.01|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous number of detected pores at Day 36 to evaluate the improvement of pores assessed by Colorface device.||||0.010
71075838|NCT05821296|141660365|OTHER||Mean Difference (Final Values)|-41.69|STANDARD_DEVIATION|73.69|<|0.004|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous number of detected pores at Day 57 to evaluate the improvement of pores assessed by Colorface device.||||<0.004
71075839|NCT05821296|141660365|OTHER||Mean Difference (Final Values)|-29.13|STANDARD_DEVIATION|61.45||0.013|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous number of detected pores at day 78 to evaluate the improvement of pores assessed by Colorface device.||||0.013
71075840|NCT05821296|141660366|OTHER||Mean Difference (Final Values)|-2832.39|STANDARD_DEVIATION|3217.15|<|0.0001|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous area of detected pores at day 15 to evaluate the improvement of pores assessed by Colorface device.||||< 0.0001
71075841|NCT05821296|141660366|OTHER||Mean Difference (Final Values)|-1754.88|STANDARD_DEVIATION|4220.25||0.025|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous area of detected pores at day 36 to evaluate the improvement of pores assessed by Colorface device.||||0.025
71075842|NCT05821296|141660366|OTHER||Mean Difference (Final Values)|-2763.41|STANDARD_DEVIATION|4965.84||0.004|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous area of detected pores at day 57 to evaluate the improvement of pores assessed by Colorface device.||||0.004
71075843|NCT05821296|141660366|OTHER||Mean Difference (Final Values)|-1742.41|STANDARD_DEVIATION|3974.21||0.021|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous area of detected pores at day 78 to evaluate the improvement of pores assessed by Colorface device.||||0.021
71075844|NCT05821296|141660367|OTHER||Mean Difference (Final Values)|-1.2|STANDARD_DEVIATION|1.3|<|0.0001|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous relative area (density) of detected pores at Day 15 to evaluate the improvement of pores assessed by Colorface device.||||<0.0001
71075845|NCT05821296|141660367|OTHER||Mean Difference (Final Values)|-0.68|STANDARD_DEVIATION|1.68||0.029|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous relative area (density) of detected pores at Day 36 to evaluate the improvement of pores assessed by Colorface device.||||0.029
71075846|NCT05821296|141660367|OTHER||Mean Difference (Final Values)|-1.07|STANDARD_DEVIATION|2.01||0.006|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous relative area (density) of detected pores at Day 57 to evaluate the improvement of pores assessed by Colorface device.||||0.006
71075847|NCT05821296|141660367|OTHER||Mean Difference (Net)|-0.65|STANDARD_DEVIATION|1.67||0.037|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous relative area (density) of detected pores at Day 78 to evaluate the improvement of pores assessed by Colorface device.||||0.037
71075848|NCT05821296|141660368|OTHER||Mean Difference (Final Values)|-0.39|STANDARD_DEVIATION|0.58||0.001|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous depth of detected pores at Day 15 to evaluate the improvement of pores assessed by Colorface device.||||0.001
71075849|NCT05821296|141660368|OTHER||Mean Difference (Final Values)|-0.14|STANDARD_DEVIATION|0.71||0.348|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous depth of detected pores at Day 36 to evaluate the improvement of pores assessed by Colorface device.||||0.348
71075850|NCT05821296|141660368|OTHER||Mean Difference (Final Values)|-0.27|STANDARD_DEVIATION|0.75||0.091|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous depth of detected pores at Day 57 to evaluate the improvement of pores assessed by Colorface device.||||0.091
71075851|NCT05821296|141660368|OTHER||Mean Difference (Final Values)|-0.12|STANDARD_DEVIATION|0.65||0.19|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous depth of detected pores at Day 78 to evaluate the improvement of pores assessed by Colorface device.||||0.190
71075852|NCT05821296|141660369|OTHER||Mean Difference (Final Values)|-1.69|STANDARD_DEVIATION|3.55||0.011|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of average area of detected pores at Day 15 to evaluate the improvement of pores assessed by Colorface device.||||0.011
71075853|NCT05821296|141660369|OTHER||Mean Difference (Final Values)|-0.64|STANDARD_DEVIATION|3.28||0.281|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of average area of detected pores at Day 36 to evaluate the improvement of pores assessed by Colorface device.||||0.281
71075854|NCT05821296|141660369|OTHER||Mean Difference (Final Values)|-1.57|STANDARD_DEVIATION|4.46||0.06|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of average area of detected pores at Day 57 to evaluate the improvement of pores assessed by Colorface device.||||0.060
71075855|NCT05821296|141660369|OTHER||Mean Difference (Final Values)|-0.87|STANDARD_DEVIATION|3.8||0.209|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of average area of detected pores at Day 78 to evaluate the improvement of pores assessed by Colorface device.||||0.209
71117727|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-11.23||||0.067|TWO_SIDED|95.0|-22.97|0.52||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||0.52|-22.97|0.067
71075856|NCT05821296|141660370|OTHER||Mean Difference (Final Values)|-26495.83|STANDARD_DEVIATION|33223.6|<|0.0001|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous volume of detected pores at Day 15 to evaluate the improvement of pores assessed by Colorface device.||||<0.0001
71075857|NCT05821296|141660370|OTHER||Mean Difference (Final Values)|-14447.02|STANDARD_DEVIATION|44054.48||0.073|TWO_SIDED||||||t-test, 2 sided|||Comparison of change from baseline of conspicuous volume of detected pores at Day 36 to evaluate the improvement of pores assessed by Colorface device.||||0.073
70940873|NCT00113880|141381687|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46||||0.01|TWO_SIDED|95.0|0.25|0.85||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.85|0.25|0.01
71075858|NCT05821296|141660370|OTHER|If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|Mean Difference (Final Values)|-25315.34|STANDARD_DEVIATION|49884.67||0.008|TWO_SIDED||||||t-test, 2 sided|||Comparison of change from baseline of conspicuous volume of detected pores at Day 57 to evaluate the improvement of pores assessed by Colorface device.||||0.008
70940874|NCT00113880|141381688|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.47||||0.01|TWO_SIDED|95.0|0.32|0.69||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.||0.69|0.32|0.01
71075859|NCT05821296|141660370|OTHER||Mean Difference (Final Values)|-13287.34|STANDARD_DEVIATION|39615.92||0.071|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous volume of detected pores at Day 78 to evaluate the improvement of pores assessed by Colorface device.||||0.071
71075860|NCT05821296|141660371|OTHER||Mean Difference (Final Values)|-7518.25|STANDARD_DEVIATION|13340.45||0.003|TWO_SIDED|||||If the Wilcoxon test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous area of line marks at Day 15 to evaluate the improvement of line marks assessed by Colorface device.||||0.003
71075861|NCT05821296|141660371|OTHER||Mean Difference (Final Values)|-7230.81|STANDARD_DEVIATION|17547.6||0.041|TWO_SIDED|||||If the Wilcoxon test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous area of line marks at Day 36 to evaluate the improvement of line marks assessed by Colorface device.||||0.041
71075862|NCT05821296|141660371|OTHER||Mean Difference (Final Values)|-9086.26|STANDARD_DEVIATION|18306.64||0.007|TWO_SIDED|||||If the Wilcoxon test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous area of line marks at Day 57 to evaluate the improvement of line marks assessed by Colorface device.||||0.007
71075863|NCT05821296|141660371|OTHER||Mean Difference (Final Values)|64.71|STANDARD_DEVIATION|14542.17||0.931|TWO_SIDED|||||If the Wilcoxon test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous area of line marks at Day 78 to evaluate the improvement of line marks assessed by Colorface device.||||0.931
71075864|NCT05821296|141660372|OTHER||Mean Difference (Final Values)|-0.36|STANDARD_DEVIATION|0.66||0.005|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous depth of line marks at Day 15 to evaluate the improvement of line marks assessed by Colorface device.||||0.005
71075865|NCT05821296|141660372|OTHER||Mean Difference (Final Values)|-0.32|STANDARD_DEVIATION|0.8||0.035|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous depth of line marks at Day 36 to evaluate the improvement of line marks assessed by Colorface device.||||0.035
71075866|NCT05821296|141660372|OTHER||Mean Difference (Final Values)|-0.34|STANDARD_DEVIATION|0.86||0.036|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous depth of line marks at Day 57 to evaluate the improvement of line marks assessed by Colorface device.||||0.036
71075867|NCT05821296|141660372|OTHER||Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.77||0.784|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous depth of line marks at Day 78 to evaluate the improvement of line marks assessed by Colorface device.||||0.784
71075868|NCT05821296|141660373|OTHER||Mean Difference (Final Values)|-2249.72|STANDARD_DEVIATION|4466.14||0.011|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.||Comparison of change from baseline of conspicuous length of line marks at Day 15 to evaluate the improvement of line marks assessed by Colorface device.||||0.011
71075869|NCT05821296|141660373|OTHER||Mean Difference (Final Values)|-2315.0|STANDARD_DEVIATION|6197.86||0.074|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous length of line marks at Day 36 to evaluate the improvement of line marks assessed by Colorface device.||||0.074
71075870|NCT05821296|141660373|OTHER||Mean Difference (Final Values)|-2700.55|STANDARD_DEVIATION|5962.3||0.007|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous length of line marks at Day 57 to evaluate the improvement of line marks assessed by Colorface device.||||0.007
71075871|NCT05821296|141660373|OTHER||Mean Difference (Final Values)|430.65|STANDARD_DEVIATION|5021.2||0.779|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous length of line marks at Day 78 to evaluate the improvement of line marks assessed by Colorface device.||||0.779
71116519|NCT00487942|141739427|SUPERIORITY_OR_OTHER||Effect size|-0.1|||||TWO_SIDED|95.0|-0.87|0.67||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.67|-0.87|
70940875|NCT00113880|141381688|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||0.01|TWO_SIDED|95.0|0.17|0.54||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox||Population: 18-49 yrs, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.||0.54|0.17|0.01
70940876|NCT01636258|141381718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.3|STANDARD_DEVIATION|2.1||0.72|TWO_SIDED|95.0|-1.4|2.0||P-value less than 0.05 considered statistically significant a priori. No multiple comparison adjustment made.|t-test, 2 sided|||No sample size calculation performed since it was a pilot study. Null hypothesis was no difference between groups.||2.0|-1.4|0.72
70940877|NCT01636258|141381719|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||No sample study calculation performed since it was a pilot study. Null hypothesis was no difference between groups.||||0.31
71116520|NCT00487942|141739427|SUPERIORITY_OR_OTHER||Effect size|0.89|||||TWO_SIDED|95.0|0.05|1.74||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.74|0.05|
71116521|NCT00487942|141739428|SUPERIORITY_OR_OTHER||Effect size|-0.25|||||TWO_SIDED|95.0|-1.05|0.55||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.55|-1.05|
71116522|NCT00487942|141739428|SUPERIORITY_OR_OTHER||Effect size|0.29|||||TWO_SIDED|95.0|-0.52|1.09||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.09|-0.52|
71116523|NCT00487942|141739428|SUPERIORITY_OR_OTHER||Effect size|0.75|||||TWO_SIDED|95.0|-0.08|1.58||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.58|-0.08|
71116524|NCT00487942|141739429|SUPERIORITY_OR_OTHER||Effect size|0.02|||||TWO_SIDED|95.0|-0.78|0.82||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.82|-0.78|
71116525|NCT00487942|141739429|SUPERIORITY_OR_OTHER||Effect size|0.55|||||TWO_SIDED|95.0|-0.27|1.36||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.36|-0.27|
71116526|NCT00487942|141739429|SUPERIORITY_OR_OTHER||Effect size|1.62|||||TWO_SIDED|95.0|0.7|2.55||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||2.55|0.70|
71116527|NCT00487942|141739430|SUPERIORITY_OR_OTHER||Effect size|0.11|||||TWO_SIDED|95.0|-0.64|0.87||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.87|-0.64|
71116528|NCT00487942|141739430|SUPERIORITY_OR_OTHER||Effect size|-0.11|||||TWO_SIDED|95.0|-0.87|0.64||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Negative Scale score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.64|-0.87|
70940878|NCT01636258|141381720|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
70940879|NCT01636258|141381721|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
71075872|NCT05821296|141660374|OTHER||Mean Difference (Final Values)|-75800.75|STANDARD_DEVIATION|142643.92||0.003|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous volume of line marks at Day 15 to evaluate the improvement of line marks assessed by Colorface device.||||0.003
71075873|NCT05821296|141660374|OTHER||Mean Difference (Final Values)|-73517.86|STANDARD_DEVIATION|197224.85||0.054|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous volume of line marks at Day 36 to evaluate the improvement of line marks assessed by Colorface device.||||0.054
71075874|NCT05821296|141660374|OTHER||Mean Difference (Final Values)|-90424.89|STANDARD_DEVIATION|198264.2||0.008|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous volume of line marks at Day 57 to evaluate the improvement of line marks assessed by Colorface device.||||0.008
71075875|NCT05821296|141660374|OTHER||Mean Difference (Final Values)|1314.03||||0.779|TWO_SIDED||||||t-test, 2 sided|||Comparison of change from baseline of conspicuous volume of line marks at Day 78 to evaluate the improvement of line marks assessed by Colorface device.||||0.779
71075876|NCT00497770|141660396|NON_INFERIORITY_OR_EQUIVALENCE|A pre-specified logistic regression was used to assess non-inferiority of DCR in African American participants compared with Caucasian participants. The DCR for African Americans was to be considered non-inferior to the DCR for Caucasians if the upper bound of the confidence interval (CI) of the odds ratio (OR) for African American versus Caucasian was \<1.78 which corresponds to a difference in proportions of approximately 14% assuming the DCR in the reference group to be 50%.|Odds Ratio (OR)|0.821|||||TWO_SIDED|95.0|0.427|1.58||Adjusted:baseline characteristics, income, marital/insurance status, comorbid, time between end of 1st line therapy and start of pemetrexed, prior platinum- or Paclitaxel-containing regimen, number of cycles and best response during 1st line therapy.|Regression, Logistic|||||1.580|0.427|
71075877|NCT03409120|141660414|SUPERIORITY||||||<|0.001|||||||linear mixed effects model|||We tested the equivalence of Burke-Fahn-Marsden scores over time (at baseline and at two time periods following DBS surgery) using a repeated measures ANOVA.||||<0.001
71075878|NCT02117713|141660443|EQUIVALENCE|Student's t-test used to test if mean change is statistically significant; null hypothesis is that the mean change from baseline is equal to zero.|Mean Difference (Net)|-28.59|STANDARD_DEVIATION|89.456||0.1157|TWO_SIDED|95.0|-64.72|7.54|||Student's t-test||Difference is only calculated in participants who had baseline and week 48 values for n= 26|||7.54|-64.72|0.1157
70853661|NCT00913458|141195448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.74||||0.1303|TWO_SIDED|95.0|-15.5|2.0|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||2.0|-15.5|0.1303
71075879|NCT02117713|141660444|EQUIVALENCE|Student's t-test used to test if mean change is statistically significant; null hypothesis is that the mean change from baseline is equal to zero.|Mean Difference (Net)|-45.15|STANDARD_DEVIATION|89.934||0.1469|TWO_SIDED|95.0|-109.48|19.19|||Student's t-test||||Difference is only calculated in participants who had baseline and week 216 values for n=10|19.19|-109.48|0.1469
71075880|NCT02117713|141660445|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|-2.353|STANDARD_DEVIATION|0.7124||0.005|TWO_SIDED|95.0|-3.101|-1.606|||Student's t-test||Difference is only calculated in participants who had baseline and week 218 values for n=6|||-1.606|-3.101|0.005
71075881|NCT02117713|141660446|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|56.0|STANDARD_DEVIATION|119.32||0.2607|TWO_SIDED|95.0|-54.4|166.4|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||166.4|-54.4|0.2607
71075882|NCT02117713|141660447|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|-141.6|STANDARD_DEVIATION|216.25||0.134|TWO_SIDED|95.0|-341.6|58.4|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||58.4|-341.6|0.1340
71075883|NCT02117713|141660448|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|47.6|STANDARD_DEVIATION|75.68||0.1474|TWO_SIDED|95.0|-22.4|117.6|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||117.6|-22.4|0.1474
71075884|NCT02117713|141660449|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.58||1|TWO_SIDED|95.0|-0.5|0.5|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||0.5|-0.5|1.00
71075885|NCT02117713|141660450|EQUIVALENCE|Student's t-test used to test if mean change is statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|-1.7|STANDARD_DEVIATION|1.38||0.0167|TWO_SIDED|95.0|-3.0|-0.4|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||-0.4|-3|0.0167
71075886|NCT02117713|141660451|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|10.9|STANDARD_DEVIATION|245.92||0.9108|TWO_SIDED|95.0|-216.6|238.3|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||238.3|-216.6|0.9108
71116529|NCT00487942|141739430|SUPERIORITY_OR_OTHER||Effect size|0.73|||||TWO_SIDED|95.0|-0.08|1.54||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Negative Scale score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.54|-0.08|
70853662|NCT00913458|141195448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.59||||0.0024|TWO_SIDED|95.0|-27.1|-6.0|||Longitudinal statisitical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-6.0|-27.1|0.0024
71075887|NCT02117713|141660452|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant(null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|0.1207|STANDARD_DEVIATION|1.882||0.1207|TWO_SIDED|95.0|-3.03|0.45|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||0.45|-3.03|0.1207
71075888|NCT02117713|141660453|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|-0.943|STANDARD_DEVIATION|1.2488||0.0927|TWO_SIDED|95.0|-2.098|0.212|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||0.212|-2.098|0.0927
71075889|NCT03168919|141660473|OTHER|Comparison||||||||||||||||The baseline and the end of therapy MRI parameters are compared.|Due to very small accrual, the statistical analysis couln't be performed.|||
71075890|NCT02195427|141660478|NON_INFERIORITY|"A WSRS change of 1 grade is considered to be clinically significant. A difference of ≤0.5 grade between the two treatment groups (i.e., half of the clinically significant difference) = non-inferiority margin.~The primary efficacy endpoint uses a paired-design and is analyzed by calculating two-sided confidence intervals of the mean difference between TEOSYAL® RHA Global Action and the control device, between the V1 enrollment visit (baseline) and V7 (24 weeks after baseline)."|Mean Difference (Final Values)|-0.03|||||TWO_SIDED|97.5|-0.17|0.11|||||The decision is based on the upper limit of the 2-sided confidence interval for the difference for the change from baseline, between test and comparator treatment. For achieving non-inferiority, the upper confidence limit of a 97.5% CI must be ≤0.5|"Efficacy of TEOSYAL® RHA Global Action versus control is analyzed in a non-inferiority statistical model using the 5-grade Wrinkle Severity Rating Scale (WSRS) as rated by the Blinded Live Evaluator at 24 weeks after baseline.~The primary endpoint is the aesthetic improvement from pre-injection of the NLF at the side of the face treated with TEOSYAL® RHA Ultra Deep compared to the one at the side of the face treated with the control device, as assessed by the BLE at 24 weeks after baseline."||0.11|-0.17|
71075891|NCT02195427|141660478|NON_INFERIORITY|"A WSRS change of 1 grade is considered to be clinically significant. A difference of ≤0.5 grade between the two treatment groups (i.e., half of the clinically significant difference) = non-inferiority margin.~The primary efficacy endpoint uses a paired-design and is analyzed by calculating two-sided confidence intervals of the mean difference between TEOSYAL® RHA Deep Lines and the control device, between the V1 enrollment visit (baseline) and V7 (24 weeks after baseline)."|Mean Difference (Final Values)|-0.1|||||TWO_SIDED|97.5|-0.25|0.06|||||The decision is based on the upper limit of the 2-sided confidence interval for the difference for the change from baseline, between test and comparator treatment. For achieving non-inferiority, the upper confidence limit of a 97.5% CI must be ≤0.5|"Efficacy of TEOSYAL® RHA Deep Lines versus control is analyzed in a non-inferiority statistical model using the 5-grade Wrinkle Severity Rating Scale (WSRS) as rated by the Blinded Live Evaluator at 24 weeks after baseline.~The primary endpoint is the aesthetic improvement from pre-injection of the NLF at the side of the face treated with TEOSYAL® RHA Deep Lines compared to the one at the side of the face treated with the control device, as assessed by the BLE at 24 weeks after baseline"||0.06|-0.25|
71075892|NCT03403621|141660503|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||Baseline versus 2 weeks||||0.42
71075893|NCT03403621|141660503|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|||Baseline versus 4 weeks||||0.72
71075894|NCT03403621|141660503|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||Baseline versus 2 weeks||||0.51
71075895|NCT03403621|141660503|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||Baseline versus 4 weeks||||0.58
71075896|NCT03403621|141660504|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Baseline versus 2 weeks||||0.03
71075897|NCT03403621|141660504|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||Baseline versus 4 weeks||||0.08
70853663|NCT00913458|141195448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.85||||0.0621|TWO_SIDED|95.0|-20.2|0.5|||Longitudinal statistical model|||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||0.5|-20.2|0.0621
71075898|NCT03403621|141660504|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Baseline versus 2 weeks||||0.02
71075899|NCT03403621|141660504|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||Baseline versus 4 weeks||||0.007
70853664|NCT00913458|141195450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.01||||0.4664|TWO_SIDED|95.0|-15.0|6.9|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||6.9|-15.0|0.4664
70853665|NCT00913458|141195450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.57||||0.021|TWO_SIDED|95.0|-30.6|-2.6|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-2.6|-30.6|0.0210
70853666|NCT00913458|141195450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.56||||0.0713|TWO_SIDED|95.0|-26.2|1.1|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||1.1|-26.2|0.0713
70853667|NCT00913458|141195452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.11||||0.0256|TWO_SIDED|95.0|-17.1|-1.1|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-1.1|-17.1|0.0256
71075900|NCT03403621|141660505|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||Baseline versus 2 weeks||||0.21
71075901|NCT03403621|141660505|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Baseline versus 4 weeks||||0.18
71075902|NCT03403621|141660505|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||Baseline versus 2 weeks||||0.33
70853668|NCT00913458|141195452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.62|||<|0.0001|TWO_SIDED|95.0|-28.1|-11.1|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-11.1|-28.1|<0.0001
71075903|NCT03403621|141660505|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||Baseline versus 4 weeks||||0.5
71075904|NCT04607980|141660526|EQUIVALENCE|Clinical equivalence of the primary endpoint was evaluated by comparing the 2-sided 95% confidence interval (CI) of the mean difference of PASI percent improvement from Baseline to Week 12 between ABP 654 versus (vs) ustekinumab with an equivalence margin of (-15, +15).|Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-3.16|3.43||||||Multiple imputation was applied for the point estimate and CI of the mean difference between the 2 groups.||3.43|-3.16|
71075905|NCT04607980|141660527|EQUIVALENCE|The mean differences and 95% CIs of PASI percent improvement between the initial randomized groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using analysis of covariance (ANCOVA) model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|1.95|||||TWO_SIDED|95.0|-2.05|5.94||||||"Week 4: Treatment Group A vs Treatment Group B.~LOCF imputation was used."||5.94|-2.05|
71075906|NCT04607980|141660527|EQUIVALENCE|The mean differences and 95% CIs of PASI percent improvement between the initial randomized groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-2.97|3.31||||||"Week 16: Treatment Group A vs Treatment Group B.~LOCF imputation was used."||3.31|-2.97|
71075907|NCT04607980|141660527|EQUIVALENCE|The mean differences and 95% CIs of PASI percent improvement between the initial randomized groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|1.34|||||TWO_SIDED|95.0|-1.39|4.07||||||"Week 28: Treatment Group A vs Treatment Group B.~LOCF imputation was used."||4.07|-1.39|
71075908|NCT04607980|141660527|EQUIVALENCE|The mean differences and 95% CIs of PASI percent improvement between the dose intensification groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|1.26|||||TWO_SIDED|95.0|-5.46|7.98||||||"Week 36: Treatment Group A vs Treatment Group B.~Observed data was used."||7.98|-5.46|
71075909|NCT04607980|141660527|EQUIVALENCE|The mean differences and 95% CIs of PASI percent improvement between the dose intensification groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|-3.71|||||TWO_SIDED|95.0|-10.71|3.28||||||"Week 44: Treatment Group A vs Treatment Group B.~Observed data was used."||3.28|-10.71|
71075910|NCT04607980|141660527|EQUIVALENCE|The mean differences and 95% CIs of PASI percent improvement between the dose intensification groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-8.45|7.13||||||"Week 52: Treatment Group A vs Treatment Group B.~Observed data was used."||7.13|-8.45|
71075911|NCT04607980|141660527|EQUIVALENCE|The differences for the mean percent change from baseline and the corresponding CIs were for ABP 654/ABP 654 minus ustekinumab/ustekinumab. Estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|-1.41|||||TWO_SIDED|95.0|-3.42|0.59||||||"Week 40: ABP 654 vs Ustekinumab.~LOCF imputation was used."||0.59|-3.42|
71075912|NCT04607980|141660527|EQUIVALENCE|The differences for the mean percent change from baseline and the corresponding CIs were for ustekinumab/ABP 654 minus ustekinumab/ustekinumab. Estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|-0.85|||||TWO_SIDED|95.0|-3.17|1.48||||||"Week 40: Ustekinumab/ABP 654 vs Ustekinumab.~LOCF imputation was used."||1.48|-3.17|
71075913|NCT04607980|141660527|EQUIVALENCE|The differences for the mean percent change from baseline and the corresponding CIs were for ABP 654/ABP 654 minus ustekinumab/ustekinumab. Estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|-0.56|||||TWO_SIDED|95.0|-3.29|2.17||||||"Week 52: ABP 654 vs Ustekinumab.~LOCF imputation was used."||2.17|-3.29|
71075914|NCT04607980|141660527|EQUIVALENCE|The differences for the mean percent change from baseline and the corresponding CIs were for ustekinumab/ABP 654 minus ustekinumab/ustekinumab. Estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-2.46|3.86||||||"Week 52: Ustekinumab/ABP 654 vs Ustekinumab.~LOCF imputation was used."||3.86|-2.46|
71075915|NCT04607980|141660528|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|1.2|||||TWO_SIDED|95.0|-4.02|6.42||||||"Week 4: Treatment Group A vs Treatment Group B.~NRI was used."||6.42|-4.02|
70853669|NCT00913458|141195452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.51||||0.0161|TWO_SIDED|95.0|-19.0|-2.0|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-2.0|-19.0|0.0161
70940880|NCT01763346|141381723|SUPERIORITY|||||||0.05||||||35 subjects per group provided 80% power to detect an effect size of 0.59, assuming a 2-sided p=0.05, adjustment for baseline measures using ANCOVA, and correlation of 0.5 between baseline and end-study measures.|General Linear Models|Differences in primary outcomes between groups at 24-months were compared using general linear models with baseline values included as covariates.||We selected a sample size that would allow detection of an effect size of \~0.6 or greater between gastric band and metformin groups for measures of β-cell function after two years, hypothesizing greater function in the gastric band group.||||0.05
70940881|NCT02186015|141381728|SUPERIORITY|A Wilcoxon signed rank test was performed.|||||<|0.01|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in serum 25(OH)D from week 0 to week 8.||||<0.01
70940882|NCT02186015|141381729|SUPERIORITY|A Wilcoxon signed rank test was performed.||||||0.24|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in worst pain rating from week 0 to week 8.||||0.24
70940883|NCT02186015|141381730|SUPERIORITY|||||||0.09|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in fatigue score from week 0 to week 8.||||0.09
70940884|NCT02186015|141381731|SUPERIORITY|||||||0.17|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in mood score from week 0 to week 8.||||0.17
70940885|NCT02186015|141381732|SUPERIORITY|||||||0.5|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in dominant handgrip strength from week 0 to week 8.||||0.50
70940886|NCT02186015|141381733|SUPERIORITY|||||||0.16|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in sleep quality assessment from week 0 to week 8.||||0.16
70940887|NCT02186015|141381734|SUPERIORITY|||||||0.75|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in functional assessment of cancer therapy-breast score from week 0 to week 8.||||0.75
71075916|NCT04607980|141660528|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-0.32|||||TWO_SIDED|95.0|-7.87|7.23||||||"Week 12: Treatment Group A vs Treatment Group B.~NRI was used."||7.23|-7.87|
71075917|NCT04607980|141660528|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|0.82|||||TWO_SIDED|95.0|-5.75|7.37||||||"Week 16: Treatment Group A vs Treatment Group B.~NRI was used."||7.37|-5.75|
71075918|NCT04607980|141660528|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|3.75|||||TWO_SIDED|95.0|-2.37|9.84||||||"Week 28: Treatment Group A vs Treatment Group B.~NRI was used."||9.84|-2.37|
71075919|NCT04607980|141660528|EQUIVALENCE|Response difference in dose intensification participants (ABP 654 - ustekinumab) was estimated by the generalized linear model adjusted for the baseline PASI and the stratification factors with an identity link was used to obtain the point estimate and 95% CI for the risk difference of PASI 75 response rate at each scheduled timepoint.|Response difference|-3.19|||||TWO_SIDED|95.0|-28.15|21.76||||||"Week 36: Treatment Group A vs Treatment Group B.~Observed data was used."||21.76|-28.15|
71075920|NCT04607980|141660528|EQUIVALENCE|Response difference (ABP 654/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|1.1|||||TWO_SIDED|95.0|-3.74|7.54||||||"Week 40: ABP 654 vs Ustekinumab.~NRI was used."||7.54|-3.74|
70940888|NCT02186015|141381735|SUPERIORITY|||||||0.19|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in functional assessment of cancer therapy-endocrine score from week 0 to week 8.||||0.19
70940889|NCT02720198|141381775|SUPERIORITY||Mean Difference (Final Values)|1.159|STANDARD_ERROR_OF_MEAN|1.834||0.53|TWO_SIDED|95.0|-2.518|4.836|||t-test, 2 sided|||||4.836|-2.518|0.53
70940890|NCT02720198|141381776|SUPERIORITY||Odds Ratio (OR)|0.492|STANDARD_ERROR_OF_MEAN|0.806||0.428|TWO_SIDED|95.0|0.101|2.388|||Mantel Haenszel|||||2.388|0.101|0.428
70940891|NCT02720198|141381777|SUPERIORITY||Odds Ratio (OR)|0.451|STANDARD_ERROR_OF_MEAN|0.724||0.272|TWO_SIDED|95.0|0.109|1.866|||Mantel Haenszel|||||1.866|0.109|0.272
70940892|NCT02720198|141381778|SUPERIORITY||Mean Difference (Final Values)|-0.624|STANDARD_ERROR_OF_MEAN|1.428||0.664|TWO_SIDED|95.0|-3.484|2.236|||t-test, 2 sided|||||2.236|-3.484|0.664
71075921|NCT04607980|141660528|EQUIVALENCE|Response difference (ustekinumab/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|1.85|||||TWO_SIDED|95.0|-4.89|8.39||||||"Week 40: Ustekinumab/ABP 654 vs Ustekinumab.~NRI was used."||8.39|-4.89|
71116530|NCT00487942|141739431|SUPERIORITY_OR_OTHER||Effect size|-0.5|||||TWO_SIDED|95.0|-1.27|0.27||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.27|-1.27|
70940893|NCT02720198|141381779|SUPERIORITY||Mean Difference (Final Values)|2.34|STANDARD_ERROR_OF_MEAN|2.199||0.292|TWO_SIDED|95.0|-2.07|6.75|||t-test, 2 sided|||||6.750|-2.070|0.292
70940894|NCT02720198|141381780|SUPERIORITY||Odds Ratio (OR)|1.063|STANDARD_ERROR_OF_MEAN|0.525||0.884|TWO_SIDED|95.0|0.38|2.971|||Mantel Haenszel|||||2.971|0.380|0.884
70940895|NCT02720198|141381781|SUPERIORITY||Odds Ratio (OR)|0.875|STANDARD_ERROR_OF_MEAN|0.65||0.905|TWO_SIDED|95.0|0.245|3.129|||Mantel Haenszel|||||3.129|0.245|0.905
70940896|NCT02720198|141381782|SUPERIORITY||Mean Difference (Final Values)|1.64|STANDARD_ERROR_OF_MEAN|1.423||0.254|TWO_SIDED|95.0|-1.211|4.492|||t-test, 2 sided|||||4.492|-1.211|0.254
71116531|NCT00487942|141739431|SUPERIORITY_OR_OTHER||Effect size|-0.28|||||TWO_SIDED|95.0|-1.05|0.5||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.50|-1.05|
71116532|NCT00487942|141739431|SUPERIORITY_OR_OTHER||Effect size|0.3|||||TWO_SIDED|95.0|-0.51|1.11||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.11|-0.51|
71116533|NCT00487942|141739432|SUPERIORITY_OR_OTHER||Effect size|-0.12|||||TWO_SIDED|95.0|-0.92|0.68||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.68|-0.92|
71116534|NCT00487942|141739432|SUPERIORITY_OR_OTHER||Effect size|0.07|||||TWO_SIDED|95.0|-0.73|0.87||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.87|-0.73|
71116535|NCT00487942|141739432|SUPERIORITY_OR_OTHER||Effect size|0.03|||||TWO_SIDED|95.0|-0.77|0.83||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.83|-0.77|
71116536|NCT00487942|141739433|SUPERIORITY_OR_OTHER||Effect size|0.0|||||TWO_SIDED|95.0|-0.8|0.8||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.80|-0.80|
71116537|NCT00487942|141739433|SUPERIORITY_OR_OTHER||Effect size|0.18|||||TWO_SIDED|95.0|-0.62|0.98||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.98|-0.62|
71116538|NCT00487942|141739433|SUPERIORITY_OR_OTHER||Effect size|0.66|||||TWO_SIDED|95.0|-0.16|1.49||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.49|-0.16|
71116539|NCT00487942|141739434|SUPERIORITY_OR_OTHER||Effect size|0.25|||||TWO_SIDED|95.0|-0.51|1.01||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the ESS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.01|-0.51|
71116540|NCT00487942|141739434|SUPERIORITY_OR_OTHER||Effect size|0.03|||||TWO_SIDED|95.0|-0.73|0.78||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the ESS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.78|-0.73|
71116541|NCT00487942|141739434|SUPERIORITY_OR_OTHER||Effect size|-0.23|||||TWO_SIDED|95.0|-1.01|0.56||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the ESS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.56|-1.01|
71116542|NCT00487942|141739435|SUPERIORITY_OR_OTHER||Effect size|0.11|||||TWO_SIDED|95.0|-0.64|0.87||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.87|-0.64|
70940897|NCT02720198|141381783|SUPERIORITY||Mean Difference (Final Values)|-3.693|STANDARD_ERROR_OF_MEAN|1.91||0.058|TWO_SIDED|95.0|-7.52|0.134|||t-test, 2 sided|||||0.134|-7.520|0.058
70940898|NCT02720198|141381784|SUPERIORITY||Mean Difference (Final Values)|-0.236|STANDARD_ERROR_OF_MEAN|2.158||0.913|TWO_SIDED|95.0|-4.559|4.088|||t-test, 2 sided|||||4.088|-4.559|0.913
70940899|NCT02720198|141381785|SUPERIORITY||Mean Difference (Final Values)|-0.459|STANDARD_ERROR_OF_MEAN|1.035||0.66|TWO_SIDED|95.0|-2.54|1.623|||t-test, 2 sided|||||1.623|-2.540|0.660
70940900|NCT02592434|141381794|SUPERIORITY||Difference in percentage|-23.69||||0.0031|TWO_SIDED|95.0|-39.41|-7.97||Threshold for significance at 0.05 level.|Normal approximation to the binomial|||In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance.||-7.97|-39.41|0.0031
70940901|NCT02592434|141381795|SUPERIORITY||Difference in percentage|19.52||||0.0166|TWO_SIDED|95.0|3.55|35.5||Threshold for significance at 0.05 level.|Normal approximation to the binomial|||In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance.||35.50|3.55|0.0166
71075922|NCT04607980|141660528|EQUIVALENCE|Response difference (ABP 654/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-2.75|||||TWO_SIDED|95.0|-8.61|4.41||||||"Week 52: ABP 654 vs Ustekinumab.~NRI was used."||4.41|-8.61|
71075923|NCT04607980|141660528|EQUIVALENCE|Response difference (ustekinumab/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|0.14|||||TWO_SIDED|95.0|-7.32|7.43||||||"Week 52: Ustekinumab/ABP 654 vs Ustekinumab.~NRI was used."||7.43|-7.32|
71075924|NCT04607980|141660529|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-0.34|||||TWO_SIDED|95.0|-3.16|3.21||||||"Week 4: Treatment Group A vs Treatment Group B.~NRI was used."||3.21|-3.16|
71075925|NCT04607980|141660529|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|1.58|||||TWO_SIDED|95.0|-5.03|8.18||||||"Week 12: Treatment Group A vs Treatment Group B.~NRI was used."||8.18|-5.03|
71116543|NCT00487942|141739435|SUPERIORITY_OR_OTHER||Effect size|-0.02|||||TWO_SIDED|95.0|-0.79|0.74||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.74|-0.79|
71116544|NCT00487942|141739435|SUPERIORITY_OR_OTHER||Effect size|-0.3|||||TWO_SIDED|95.0|-1.11|0.5||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.50|-1.11|
71116545|NCT00487942|141739436|SUPERIORITY_OR_OTHER||Effect size|-0.15|||||TWO_SIDED|95.0|-0.95|0.65||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.65|-0.95|
71116546|NCT00487942|141739436|SUPERIORITY_OR_OTHER||Effect size|-0.07|||||TWO_SIDED|95.0|-0.87|0.73||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.73|-0.87|
71116547|NCT00487942|141739436|SUPERIORITY_OR_OTHER||Effect size|-0.43|||||TWO_SIDED|95.0|-1.24|0.38||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.38|-1.24|
71075926|NCT04607980|141660529|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|3.81|||||TWO_SIDED|95.0|-3.62|11.17||||||"Week 16: Treatment Group A vs Treatment Group B.~NRI was used."||11.17|-3.62|
71075927|NCT04607980|141660529|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|3.07|||||TWO_SIDED|95.0|-4.68|10.78||||||"Week 28: Treatment Group A vs Treatment Group B.~NRI was used."||10.78|-4.68|
71075928|NCT04607980|141660529|EQUIVALENCE|Response difference (ABP 654/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-1.93|||||TWO_SIDED|95.0|-12.85|8.89||||||"Week 40: ABP 654 vs Ustekinumab.~NRI was used."||8.89|-12.85|
71075929|NCT04607980|141660529|EQUIVALENCE|Response difference (ustekinumab/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-4.93|||||TWO_SIDED|95.0|-17.39|7.73||||||"Week 40: Ustekinumab/ABP 654 vs Ustekinumab.~NRI was used."||7.73|-17.39|
71075930|NCT04607980|141660529|EQUIVALENCE|Response difference (ABP 654/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|2.55|||||TWO_SIDED|95.0|-8.42|13.3||||||"Week 52: ABP 654 vs Ustekinumab.~NRI was used."||13.30|-8.42|
71075931|NCT04607980|141660529|EQUIVALENCE|Response difference (ustekinumab/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-2.41|||||TWO_SIDED|95.0|-14.91|10.19||||||"Week 52: Ustekinumab/ABP 654 vs Ustekinumab.~NRI was used."||10.19|-14.91|
71075932|NCT04607980|141660530|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|2.55|||||TWO_SIDED|95.0|-5.65|10.71||||||"Week 12: Treatment Group A vs Treatment Group B.~NRI was used."||10.71|-5.65|
71075933|NCT04607980|141660530|EQUIVALENCE|Response difference (ABP 654/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-6.57|||||TWO_SIDED|95.0|-15.41|3.29||||||"Week 52: ABP 654 vs Ustekinumab.~NRI was used."||3.29|-15.41|
71075934|NCT04607980|141660530|EQUIVALENCE|Response difference (ustekinumab/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-7.46|||||TWO_SIDED|95.0|-18.41|3.74||||||"Week 52: ABP 654/Ustekinumab vs Ustekinumab.~NRI was used."||3.74|-18.41|
71075935|NCT04607980|141660531|EQUIVALENCE|Mean difference estimated for treatment group A and treatment group B using ANCOVA model adjusted for baseline BSA value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|0.47|||||TWO_SIDED|95.0|-1.15|2.1||||||"Week 12: Treatment Group A vs Treatment Group B.~LOCF imputation was used."||2.10|-1.15|
71075936|NCT04607980|141660531|EQUIVALENCE|Mean difference estimated in dose intensification participants (treatment group A and treatment group B) using ANCOVA model adjusted for baseline BSA value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|1.39|||||TWO_SIDED|95.0|-0.9|3.67||||||"Week 52: Treatment Group A vs Treatment Group B.~Observed data was used."||3.67|-0.90|
71075937|NCT04607980|141660531|EQUIVALENCE|Mean difference estimated for ABP 654/ ABP 654 and ustekinumab/ ustekinumab using ANCOVA model adjusted for baseline BSA value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|-0.13|||||TWO_SIDED|95.0|-0.99|0.74||||||"Week 52: ABP 654 vs Ustekinumab.~LOCF imputation was used."||0.74|-0.99|
71075938|NCT04607980|141660531|EQUIVALENCE|Mean difference estimated for ustekinumab/ABP 654 and ustekinumab/ ustekinumab using ANCOVA model adjusted for baseline BSA value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.9|1.1||||||"Week 52: Ustekinumab/ABP 654 vs Ustekinumab.~LOCF imputation was used."||1.10|-0.90|
71075939|NCT00727090|141660535|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence|||||<|0.05|||||||t-test, 2 sided|||Null Hypothesis: Change in serum sodium from baseline is not different between groups||||<0.05
71075940|NCT03334422|141660596|SUPERIORITY||Odds Ratio (OR)|2.58||||0.026|TWO_SIDED|95.0|1.12|5.92|||Regression, Logistic|||||5.92|1.12|0.026
71075941|NCT03334422|141660596|SUPERIORITY||Odds Ratio (OR)|3.64||||0.001|TWO_SIDED|95.0|1.64|8.05|||Regression, Logistic|||||8.05|1.64|0.001
71075942|NCT03334422|141660597|SUPERIORITY||Odds Ratio (OR)|2.13||||0.085|TWO_SIDED|95.0|0.9|5.02|||Regression, Logistic|||||5.02|0.90|0.085
71075943|NCT03334422|141660598|SUPERIORITY||Odds Ratio (OR)|2.35||||0.024|TWO_SIDED|95.0|1.12|4.93|||Regression, Logistic|||||4.93|1.12|0.024
71075944|NCT03334422|141660598|SUPERIORITY||Odds Ratio (OR)|3.49|||<|0.001|TWO_SIDED|95.0|1.73|7.04|||Regression, Logistic|||||7.04|1.73|<0.001
71075945|NCT03334422|141660598|SUPERIORITY||Odds Ratio (OR)|4.41|||<|0.001|TWO_SIDED|95.0|2.22|8.76|||Regression, Logistic|||||8.76|2.22|<0.001
71075946|NCT03334422|141660599|SUPERIORITY||Odds Ratio (OR)|2.8||||0.053|TWO_SIDED|95.0|0.99|7.97|||Regression, Logistic|||||7.97|0.99|0.053
71075947|NCT03334422|141660599|SUPERIORITY||Odds Ratio (OR)|3.87||||0.007|TWO_SIDED|95.0|1.44|10.41|||Regression, Logistic|||||10.41|1.44|0.007
71075948|NCT03334422|141660599|SUPERIORITY||Odds Ratio (OR)|6.2|||<|0.001|TWO_SIDED|95.0|2.42|15.91|||Regression, Logistic|||||15.91|2.42|<0.001
71075949|NCT03334422|141660600|SUPERIORITY||Mean Difference (Net)|-12.76|STANDARD_ERROR_OF_MEAN|6.81||0.062|TWO_SIDED|95.0|-26.19|0.66|||Mixed Models Analysis|||||0.66|-26.19|0.062
71075950|NCT03334422|141660600|SUPERIORITY||Mean Difference (Net)|-25.89|STANDARD_ERROR_OF_MEAN|6.54|<|0.001|TWO_SIDED|95.0|-38.78|-12.99|||Mixed Models Analysis|||||-12.99|-38.78|<0.001
71075951|NCT03334422|141660600|SUPERIORITY||Mean Difference (Net)|-25.97|STANDARD_ERROR_OF_MEAN|6.24|<|0.001|TWO_SIDED|95.0|-38.29|-13.65|||Mixed Models Analysis|||||-13.65|-38.29|<0.001
71075952|NCT03334422|141660601|SUPERIORITY||Odds Ratio (OR)|2.9||||0.086|TWO_SIDED|95.0|0.86|9.76|||Regression, Logistic|||||9.76|0.86|0.086
71075953|NCT03334422|141660601|SUPERIORITY||Odds Ratio (OR)|4.95||||0.006|TWO_SIDED|95.0|1.58|15.49|||Regression, Logistic|||||15.49|1.58|0.006
70940902|NCT02592434|141381796|SUPERIORITY||Difference in percentage|23.69||||0.0031|TWO_SIDED|95.0|7.97|39.41||Threshold for significance at 0.05 level.|Normal approximation to the binomial|||In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance.||39.41|7.97|0.0031
70940903|NCT02592434|141381797|SUPERIORITY||Difference in percentage|17.02||||0.0387|TWO_SIDED|95.0|0.88|33.17||Threshold for significance at 0.05 level.|Normal approximation to the binomial|||In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance.||33.17|0.88|0.0387
70940904|NCT02592434|141381798|SUPERIORITY||Ls mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0292|TWO_SIDED|95.0|-0.22|-0.01||Threshold for significance at 0.05 level.|Mixed Model for Repeated Measures (MMRM)|||In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance. Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-0.01|-0.22|0.0292
70940905|NCT02592434|141381800|SUPERIORITY||Difference in percentage|-1.71||||0.741|TWO_SIDED|95.0|-11.82|8.41|||Normal approximation to the binomial|||at Week 20||8.41|-11.82|0.7410
70940906|NCT02592434|141381800|SUPERIORITY||Difference in percentage|-18.93||||0.0052|TWO_SIDED|95.0|-32.22|-5.64|||Normal approximation to the binomial|||at Week 24||-5.64|-32.22|0.0052
70940907|NCT02592434|141381800|SUPERIORITY||Difference in percentage|-19.09||||0.0093|TWO_SIDED|95.0|-33.48|-4.7|||Normal approximation to the binomial|||at Week 28||-4.70|-33.48|0.0093
71075954|NCT03334422|141660601|SUPERIORITY||Odds Ratio (OR)|7.4|||<|0.001|TWO_SIDED|95.0|2.51|21.83|||Regression, Logistic|||||21.83|2.51|<0.001
70940908|NCT02592434|141381800|SUPERIORITY||Difference in percentage|-22.1||||0.0045|TWO_SIDED|95.0|-37.35|-6.86|||Normal approximation to the binomial|||at Week 32||-6.86|-37.35|0.0045
71075955|NCT03334422|141660602|SUPERIORITY||Odds Ratio (OR)|1.41||||0.505|TWO_SIDED|95.0|0.51|3.87|||Regression, Logistic|||||3.87|0.51|0.505
71075956|NCT03334422|141660602|SUPERIORITY||Odds Ratio (OR)|3.64||||0.002|TWO_SIDED|95.0|1.6|8.27|||Regression, Logistic|||||8.27|1.60|0.002
71075957|NCT03334422|141660602|SUPERIORITY||Odds Ratio (OR)|4.91|||<|0.001|TWO_SIDED|95.0|2.22|10.86|||Regression, Logistic|||||10.86|2.22|<0.001
71075958|NCT03334422|141660603|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.15||0.074|TWO_SIDED|95.0|-0.57|0.03|||Mixed Models Analysis|||||0.03|-0.57|0.074
71075959|NCT03334422|141660603|SUPERIORITY||Mean Difference (Net)|-0.38|STANDARD_ERROR_OF_MEAN|0.15||0.011|TWO_SIDED|95.0|-0.68|-0.09|||Mixed Models Analysis|||||-0.09|-0.68|0.011
71075960|NCT03334422|141660603|SUPERIORITY||Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.84|-0.26|||Mixed Models Analysis|||||-0.26|-0.84|<0.001
71075961|NCT03334422|141660604|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.41||0.58|TWO_SIDED|95.0|-1.05|0.59|||Mixed Models Analysis|||||0.59|-1.05|0.580
71075962|NCT03334422|141660604|SUPERIORITY||Mean Difference (Net)|-1.75|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.54|-0.96|||Mixed Models Analysis|||||-0.96|-2.54|<0.001
71075963|NCT03334422|141660604|SUPERIORITY||Mean Difference (Net)|-1.62|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|-2.37|-0.87|||Mixed Models Analysis|||||-0.87|-2.37|<0.001
70853670|NCT02279407|141195453|SUPERIORITY_OR_OTHER||Geometric mean ratio for difference|0.83||||0.046|TWO_SIDED|95.0|0.7|1.0||Hypotheses tested using Dunnett's multiple testing procedure with a family-wise error rate of 5%, adjusting for 3 pairwise comparisons versus a single control (placebo).|Mixed Models Analysis|||||1.00|0.70|0.046
70940909|NCT02592434|141381800|SUPERIORITY||Difference in percentage|-23.57||||0.0027|TWO_SIDED|95.0|-38.97|-8.17|||Normal approximation to the binomial|||at Week 36||-8.17|-38.97|0.0027
70940910|NCT02592434|141381800|SUPERIORITY||Difference in percentage|-25.08||||0.0016|TWO_SIDED|95.0|-40.69|-9.47|||Normal approximation to the binomial|||at Week 40||-9.47|-40.69|0.0016
70940911|NCT02592434|141381804|SUPERIORITY||Difference in percentage|6.03||||0.301|TWO_SIDED|95.0|-5.4|17.46|||Normal approximation to the binomial|||at Week 20||17.46|-5.40|0.3010
70940912|NCT02592434|141381804|SUPERIORITY||Difference in percentage|17.54||||0.0108|TWO_SIDED|95.0|4.05|31.03|||Normal approximation to the binomial|||at Week 24||31.03|4.05|0.0108
70940913|NCT02592434|141381804|SUPERIORITY||Difference in percentage|19.13||||0.0103|TWO_SIDED|95.0|4.51|33.74|||Normal approximation to the binomial|||at Week 28||33.74|4.51|0.0103
71075964|NCT03334422|141660605|SUPERIORITY||Odds Ratio (OR)|1.67||||0.094|TWO_SIDED|95.0|0.92|3.04|||Regression, Logistic|||||3.04|0.92|0.094
71075965|NCT03334422|141660605|SUPERIORITY||Odds Ratio (OR)|2.91|||<|0.001|TWO_SIDED|95.0|1.65|5.11|||Regression, Logistic|||||5.11|1.65|<0.001
71075966|NCT03334422|141660605|SUPERIORITY||Odds Ratio (OR)|3.15|||<|0.001|TWO_SIDED|95.0|1.8|5.51|||Regression, Logistic|||||5.51|1.80|<0.001
71075967|NCT03334422|141660606|SUPERIORITY||Odds Ratio (OR)|1.57||||0.528|TWO_SIDED|95.0|0.39|6.31|||Regression, Logistic|||||6.31|0.39|0.528
71075968|NCT03334422|141660606|SUPERIORITY||Odds Ratio (OR)|2.56||||0.142|TWO_SIDED|95.0|0.73|8.95|||Regression, Logistic|||||8.95|0.73|0.142
71075969|NCT03334422|141660606|SUPERIORITY||Odds Ratio (OR)|2.68||||0.123|TWO_SIDED|95.0|0.77|9.37|||Regression, Logistic|||||9.37|0.77|0.123
71075970|NCT03334422|141660607|SUPERIORITY||LSMean Difference|-6.88|STANDARD_ERROR_OF_MEAN|3.63||0.059|TWO_SIDED|95.0|-14.03|0.28|||Mixed Models Analysis|||||0.28|-14.03|0.059
71075971|NCT03334422|141660607|SUPERIORITY||LSMean Difference|-14.48|STANDARD_ERROR_OF_MEAN|3.47|<|0.001|TWO_SIDED|95.0|-21.32|-7.63|||Mixed Models Analysis|||||-7.63|-21.32|<0.001
71075972|NCT03334422|141660607|SUPERIORITY||LSMean Difference|-14.15|STANDARD_ERROR_OF_MEAN|3.32|<|0.001|TWO_SIDED|95.0|-20.69|-7.61|||Mixed Models Analysis|||||-7.61|-20.69|<0.001
71075973|NCT03334422|141660608|SUPERIORITY||Odds Ratio (OR)|2.55||||0.193|TWO_SIDED|95.0|0.62|10.45|||Regression, Logistic|||||10.45|0.62|0.193
71075974|NCT03334422|141660608|SUPERIORITY||Odds Ratio (OR)|4.1||||0.042|TWO_SIDED|95.0|1.05|16.03|||Mixed Models Analysis|||||16.03|1.05|0.042
71075975|NCT03334422|141660608|SUPERIORITY||Odds Ratio (OR)|3.89||||0.044|TWO_SIDED|95.0|1.04|14.57|||Regression, Logistic|||||14.57|1.04|0.044
71075976|NCT03334422|141660609|SUPERIORITY||LSMean Difference|-6.16|STANDARD_ERROR_OF_MEAN|3.23||0.058|TWO_SIDED|95.0|-12.53|0.21|||Mixed Models Analysis|||||0.21|-12.53|0.058
71075977|NCT03334422|141660609|SUPERIORITY||LSMean Difference|-9.3|STANDARD_ERROR_OF_MEAN|3.1||0.003|TWO_SIDED|95.0|-15.42|-3.18|||Mixed Models Analysis|||||-3.18|-15.42|0.003
71116548|NCT00487942|141739437|SUPERIORITY_OR_OTHER||Effect size|0.06|||||TWO_SIDED|95.0|-0.75|0.86||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.86|-0.75|
71116549|NCT00487942|141739437|SUPERIORITY_OR_OTHER||Effect size|-0.19|||||TWO_SIDED|95.0|-0.99|0.62||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.62|-0.99|
70853671|NCT02279407|141195454|SUPERIORITY_OR_OTHER||Geometric mean ratio for difference|0.91||||0.502|TWO_SIDED|95.0|0.75|1.11||Conditional upon rejection of at least 1 of the 3 hypotheses for the primary analysis, secondary hypotheses are tested using Tukey's multiple testing procedure with a family-wise error rate of 5%, adjusting for 3 pairwise comparisons.|Mixed Models Analysis|||||1.11|0.75|0.502
70853672|NCT02279407|141195454|SUPERIORITY_OR_OTHER||Geometric mean ratio for difference|0.91||||0.562|TWO_SIDED|95.0|0.73|1.13||Conditional upon rejection of at least 1 of the hypotheses for the primary analysis, secondary hypotheses are tested using Tukey's multiple testing procedure with a family-wise error rate of 5%, adjusting for 3 pairwise comparisons.|Mixed Models Analysis|||||1.13|0.73|0.562
70853673|NCT01816945|141195459|SUPERIORITY|||||||0.15|||||||Fisher Exact|||||||0.15
70853674|NCT01816945|141195462|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||Two-sample t-test for PHQ-9 at 12 months||||0.96
70853675|NCT01816945|141195463|SUPERIORITY|||||||0.043|||||||t-test, 2 sided|||Two-sample t-test for Social Network Score at 12 month||||0.043
70853676|NCT00422084|141195467|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The primary efficacy analysis tested the non-inferiority of the PA group compared to the comparator group with regard to the PCR-corrected ACPR response rate at Day 28 using the 2-sided 95% confidence interval (CI) (Newcombe-Wilson score method without continuity correction) and a 5% non-inferiority margin. Non-inferiority was demonstrated if the lower limit of the CI for the difference \>-5%.|ACPR percent difference|0.3||||0.578|TWO_SIDED|95.0|-0.7|1.8||If non-inferiority of PA is demonstrated, the p-value associated with a superiority test was calculated based on a 2-sided Chi-square test. If the calculated p-value is \<5%, then the superiority of PA compared to AL is statistically demonstrated.|Chi-squared|||"Null hypothesis: The PCR-corrected ACPR response rate at Day 28 for the PA group is inferior to the PCR-corrected ACPR response rate at Day 28 for the comparator group (AL) by more than 5%.~Was tested versus the alternative:~Alternative hypothesis: The PCR-corrected ACPR response rate at Day 28 for the PA group is not inferior to the PCR-corrected ACPR response rate at Day 28 for the comparator group (AL) by more than -5%."||1.8|-0.7|0.578
70853677|NCT00759564|141195494|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|124.71|||||TWO_SIDED|90.0|106.57|145.94||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||145.94|106.57|
70853678|NCT00759564|141195494|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|163.51|||||TWO_SIDED|90.0|139.72|191.34||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||191.34|139.72|
70853679|NCT00759564|141195494|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|58.4|||||TWO_SIDED|90.0|48.16|70.83||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||70.83|48.16|
70853680|NCT00759564|141195496|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|167.59|||||TWO_SIDED|90.0|137.27|204.61||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||204.61|137.27|
70853681|NCT00759564|141195496|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|246.76|||||TWO_SIDED|90.0|202.11|301.27||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||301.27|202.11|
70940914|NCT02592434|141381804|SUPERIORITY||Difference in percentage|23.53||||0.0025|TWO_SIDED|95.0|8.27|38.8|||Normal approximation to the binomial|||at Week 32||38.80|8.27|0.0025
71075978|NCT03334422|141660609|SUPERIORITY||LSMean Difference|-11.16|STANDARD_ERROR_OF_MEAN|2.98|<|0.001|TWO_SIDED|95.0|-17.03|-5.3|||Mixed Models Analysis|||||-5.30|-17.03|<0.001
71075979|NCT03334422|141660610|SUPERIORITY|||||||0.189|||||||Fisher Exact|||||||0.189
71075980|NCT03334422|141660610|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
71075981|NCT03334422|141660610|SUPERIORITY|||||||0.383|||||||Fisher Exact|||||||0.383
71075982|NCT03334422|141660611|SUPERIORITY||LSMean Difference|-14.8|STANDARD_ERROR_OF_MEAN|8.46||0.081|TWO_SIDED|95.0|-31.45|1.85|||Mixed Models Analysis|||||1.85|-31.45|0.081
71116550|NCT00487942|141739437|SUPERIORITY_OR_OTHER||Effect size|-0.47|||||TWO_SIDED|95.0|-1.28|0.34||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.34|-1.28|
71116551|NCT03040011|141739473|SUPERIORITY|||||||0.39|||||||Kruskal-Wallis|||||||0.39
71116552|NCT03040011|141739474|SUPERIORITY|||||||0.25|||||||Kruskal-Wallis|||||||0.25
71116553|NCT03040011|141739475|SUPERIORITY|||||||0.17|||||||Kruskal-Wallis|||||||0.17
71116554|NCT03040011|141739476|SUPERIORITY|||||||0.45|||||||Kruskal-Wallis|||||||0.45
71116555|NCT03040011|141739477|SUPERIORITY|||||||0.54|||||||Kruskal-Wallis|||||||0.54
71116556|NCT03040011|141739478|SUPERIORITY|||||||0.8|||||||Chi-squared|||||||0.80
71116557|NCT03040011|141739479|SUPERIORITY|||||||0.72|||||||Chi-squared|||||||0.72
71116558|NCT03040011|141739480|SUPERIORITY|||||||0.64|||||||Chi-squared|||||||0.64
71116559|NCT03040011|141739481|SUPERIORITY|||||||0.41|||||||Kruskal-Wallis|||||||0.41
71116560|NCT03040011|141739483|SUPERIORITY|||||||0.96|||||||Chi-squared|||||||0.96
71116561|NCT03040011|141739484|SUPERIORITY|||||||0.9|||||||Chi-squared|||||||0.90
71116562|NCT03040011|141739485|SUPERIORITY|||||||0.49|||||||Chi-squared|||||||0.49
70853682|NCT00759564|141195496|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|107.13|||||TWO_SIDED|90.0|88.06|130.32||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||130.32|88.06|
70853683|NCT00759564|141195497|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|168.14|||||TWO_SIDED|90.0|137.4|205.75||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||205.75|137.40|
71116563|NCT03040011|141739486|SUPERIORITY|||||||0.19|||||||Chi-squared|||||||0.19
71116564|NCT03040011|141739487|SUPERIORITY|||||||0.35|||||||Kruskal-Wallis|||||||0.35
71116565|NCT03040011|141739488|SUPERIORITY|||||||0.32|||||||Kruskal-Wallis|||||||0.32
71116566|NCT03040011|141739489|SUPERIORITY|||||||0.18|||||||Kruskal-Wallis|||||||0.18
71116567|NCT03040011|141739490|SUPERIORITY|||||||0.68|||||||Kruskal-Wallis|||||||0.68
71116568|NCT03040011|141739491|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||||||0.40
71116569|NCT03040011|141739492|SUPERIORITY|||||||0.44|||||||Kruskal-Wallis|||||||0.44
71116570|NCT00678535|141739505|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.091||||0.3158||95.0|0.92|1.292|||Stratified log rank||Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.|Primary efficacy analysis: To test equality of progression free survival time between treatment groups, applying the two-sided stratified log-rank test (randomization strata: disease stage, previous oesophagectomy/gastrectomy and prior(neo-) adjuvant(radio) chemotherapy, α=5%).||1.292|0.920|0.3158
71116571|NCT00678535|141739506|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.004||||0.9547||95.0|0.866|1.165|||Stratified log rank||Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.|To test equality of OS time between treatment groups, applying the two-sided stratified log-rank test (randomization strata: disease stage, previous oesophagectomy/gastrectomy and prior (neo-) adjuvant(radio) chemotherapy, α=5%)||1.165|0.866|0.9547
71116572|NCT00678535|141739507|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0435||||0.7696||95.0|0.7844|1.3882|||Cochran-Mantel-Haenszel|||The best overall response rate was compared with the Cochran-Mantel-Haenszel test (strata: disease stage, previous oesophagectomy/gastrectomy and prior(neo-) adjuvant(radio) chemotherapy, two-sided with α=5%).||1.3882|0.7844|0.7696
71116573|NCT02578680|141739555|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|1e-05|TWO_SIDED|95.0|0.43|0.64|||Log Rank||Based on Cox regression model with treatment as a covariate stratified by PD-L1 status (≥1% vs. \<1%), platinum chemotherapy (cisplatin vs. carboplatin) \& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.|||0.64|0.43|<0.00001
71116574|NCT02578680|141739556|SUPERIORITY||Hazard Ratio (HR)|0.49|||<|1e-05|TWO_SIDED|95.0|0.38|0.64|||Log Rank||Based on Cox regression model with treatment as a covariate stratified by PD-L1 status (≥1% vs. \<1%), platinum chemotherapy (cisplatin vs. carboplatin) \& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.|||0.64|0.38|<0.00001
71116575|NCT02578680|141739557|SUPERIORITY||Difference in Percentage vs. Control|28.5|||<|0.0001|TWO_SIDED|95.0|21.1|35.4||H0:Difference in percentages=0 vs H1:Difference in percentages\>0|Stratified Miettinen and Nurminen||Miettinen and Nurminen method with treatment as a covariate stratified by PD-L1 status (≥1% vs. \<1%), platinum chemotherapy (cisplatin vs. carboplatin) \& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.|||35.4|21.1|<0.0001
71075983|NCT03334422|141660611|SUPERIORITY||LSMean Difference|-30.66|STANDARD_ERROR_OF_MEAN|8.11|<|0.001|TWO_SIDED|95.0|-46.62|-14.7|||Mixed Models Analysis|||||-14.70|-46.62|<0.001
71075984|NCT03334422|141660611|SUPERIORITY||LSMean Difference|-30.28|STANDARD_ERROR_OF_MEAN|7.63|<|0.001|TWO_SIDED|95.0|-45.29|-15.27|||Mixed Models Analysis|||||-15.27|-45.29|<0.001
71075985|NCT03334422|141660612|SUPERIORITY||LSMean Difference|-2.36|STANDARD_ERROR_OF_MEAN|1.32||0.075|TWO_SIDED|95.0|-4.97|0.24|||Mixed Models Analysis|||||0.24|-4.97|0.075
71075986|NCT03334422|141660612|SUPERIORITY||LSMean Difference|-5.58|STANDARD_ERROR_OF_MEAN|1.27|<|0.001|TWO_SIDED|95.0|-8.07|-3.08|||Mixed Models Analysis|||||-3.08|-8.07|<0.001
71075987|NCT03334422|141660612|SUPERIORITY||LSMean Difference|-6.07|STANDARD_ERROR_OF_MEAN|1.21|<|0.001|TWO_SIDED|95.0|-8.47|-3.68|||Mixed Models Analysis|||||-3.68|-8.47|<0.001
71075988|NCT03334422|141660613|SUPERIORITY||LSMean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.17||0.13|TWO_SIDED|95.0|-0.61|0.08|||Mixed Models Analysis|||||0.08|-0.61|0.130
71075989|NCT03334422|141660613|SUPERIORITY||LSMean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-0.94|-0.28|||Mixed Models Analysis|||||-0.28|-0.94|<0.001
71075990|NCT03334422|141660613|SUPERIORITY||LSMean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.0|-0.38|||Mixed Models Analysis|||||-0.38|-1.00|<0.001
71075991|NCT03334422|141660614|SUPERIORITY||LSMean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.51||0.067|TWO_SIDED|95.0|-1.95|0.07|||Mixed Models Analysis|||HADS Anxiety.||0.07|-1.95|0.067
71075992|NCT03334422|141660614|SUPERIORITY||LSMean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.49||0.06|TWO_SIDED|95.0|-1.89|0.04|||Mixed Models Analysis|||HADS Anxiety.||0.04|-1.89|0.060
71075993|NCT03334422|141660614|SUPERIORITY||LSMean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.47||0.006|TWO_SIDED|95.0|-2.23|-0.38|||Mixed Models Analysis|||HADS Anxiety.||-0.38|-2.23|0.006
71075994|NCT03334422|141660614|SUPERIORITY||LSMean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.51||0.321|TWO_SIDED|95.0|-1.5|0.49|||Mixed Models Analysis|||HADS Depression.||0.49|-1.50|0.321
71075995|NCT03334422|141660614|SUPERIORITY||LSMean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.49||0.143|TWO_SIDED|95.0|-1.67|0.24|||Mixed Models Analysis|||HADS Depression.||0.24|-1.67|0.143
71075996|NCT03334422|141660614|SUPERIORITY||LSMean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.47||0.012|TWO_SIDED|95.0|-2.11|-0.26|||Mixed Models Analysis|||HADS Depression.||-0.26|-2.11|0.012
71075997|NCT03334422|141660615|SUPERIORITY||LSMean Difference|-1.76|STANDARD_ERROR_OF_MEAN|0.97||0.071|TWO_SIDED|95.0|-3.67|0.15|||Mixed Models Analysis|||||0.15|-3.67|0.071
71075998|NCT03334422|141660615|SUPERIORITY||LSMean Difference|-4.09|STANDARD_ERROR_OF_MEAN|0.93|<|0.001|TWO_SIDED|95.0|-5.92|-2.26|||Mixed Models Analysis|||||-2.26|-5.92|<0.001
71075999|NCT03334422|141660615|SUPERIORITY||LSMean Difference|-4.22|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.98|-2.45|||Mixed Models Analysis|||||-2.45|-5.98|<0.001
71076000|NCT03334422|141660616|SUPERIORITY||LSMean Difference|-0.91|STANDARD_ERROR_OF_MEAN|5.17||0.861|TWO_SIDED|95.0|-11.16|9.34|||Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline||9.34|-11.16|0.861
71076001|NCT03334422|141660616|SUPERIORITY||LSMean Difference|1.01|STANDARD_ERROR_OF_MEAN|5.03||0.841|TWO_SIDED|95.0|-8.94|10.97||Absenteeism|Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline||10.97|-8.94|0.841
71076002|NCT03334422|141660616|SUPERIORITY||LSMean Difference|5.16|STANDARD_ERROR_OF_MEAN|4.6||0.264|TWO_SIDED|95.0|-3.95|14.26|||Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline||14.26|-3.95|0.264
71076003|NCT03334422|141660616|SUPERIORITY||LSMean Difference|-3.12|STANDARD_ERROR_OF_MEAN|5.63||0.58|TWO_SIDED|95.0|-14.26|8.02|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline||8.02|-14.26|0.580
71076004|NCT03334422|141660616|SUPERIORITY||LSMean Difference|-13.56|STANDARD_ERROR_OF_MEAN|5.5||0.015|TWO_SIDED|95.0|-24.45|-2.86|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline||-2.86|-24.45|0.015
71076005|NCT03334422|141660616|SUPERIORITY||LSMean Difference|-13.13|STANDARD_ERROR_OF_MEAN|5.08||0.011|TWO_SIDED|95.0|-23.2|-3.06|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline||-3.06|-23.20|0.011
71076006|NCT03334422|141660616|SUPERIORITY||LSMean Difference|-1.81|STANDARD_ERROR_OF_MEAN|6.71||0.788|TWO_SIDED|95.0|-15.12|11.49|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline||11.49|-15.12|0.788
71076007|NCT03334422|141660616|SUPERIORITY||LSMean Difference|-9.48|STANDARD_ERROR_OF_MEAN|6.57||0.152|TWO_SIDED|95.0|-22.51|3.55|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline||3.55|-22.51|0.152
71076008|NCT03334422|141660616|SUPERIORITY|Overall Work Impairment|LSMean Difference|-9.13|STANDARD_ERROR_OF_MEAN|6.07||0.135|TWO_SIDED|95.0|-21.17|2.9|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline||2.90|-21.17|0.135
71076009|NCT03334422|141660616|SUPERIORITY||LSMean Difference|-2.26|STANDARD_ERROR_OF_MEAN|4.25||0.595|TWO_SIDED|95.0|-10.65|6.12|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline||6.12|-10.65|0.595
71076010|NCT03334422|141660616|SUPERIORITY||LSMean Difference|-14.3|STANDARD_ERROR_OF_MEAN|4.12|<|0.001|TWO_SIDED|95.0|-22.43|-6.17|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline||-6.17|-22.43|<0.001
71076011|NCT03334422|141660616|SUPERIORITY||LSMean Difference|-14.47|STANDARD_ERROR_OF_MEAN|3.88|<|0.001|TWO_SIDED|95.0|-22.11|-6.83|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline||-6.83|-22.11|<0.001
71076012|NCT03334422|141660617|SUPERIORITY||LSMean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.295|TWO_SIDED|95.0|-0.02|0.07|||Mixed Models Analysis|||Health State Index Score (US Algorithm)||0.07|-0.02|0.295
71076013|NCT03334422|141660617|SUPERIORITY||LSMean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.02||0.001|TWO_SIDED|95.0|0.03|0.12|||Mixed Models Analysis|||Health State Index Score (US Algorithm)||0.12|0.03|0.001
71076014|NCT03334422|141660617|SUPERIORITY||LSMean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|95.0|0.03|0.12|||Mixed Models Analysis|||Health State Index Score (US Algorithm)||0.12|0.03|<0.001
71076015|NCT03334422|141660617|SUPERIORITY||LSMean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.334|TWO_SIDED|95.0|-0.03|0.1|||Mixed Models Analysis|||Health State Index Score (UK Algorithm)||0.10|-0.03|0.334
71076016|NCT03334422|141660617|SUPERIORITY||LSMean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.03||0.001|TWO_SIDED|95.0|0.04|0.17|||Mixed Models Analysis|||Health State Index Score (UK Algorithm)||0.17|0.04|0.001
70940915|NCT02592434|141381804|SUPERIORITY||Difference in percentage|25.04||||0.0016|TWO_SIDED|95.0|9.52|40.56|||Normal approximation to the binomial|||at Week 36||40.56|9.52|0.0016
70940916|NCT02592434|141381804|SUPERIORITY||Difference in percentage|23.69||||0.0031|TWO_SIDED|95.0|7.97|39.41|||Normal approximation to the binomial|||at Week 40||39.41|7.97|0.0031
71116576|NCT02578680|141739561|SUPERIORITY||Hazard Ratio (HR)|0.49|||<|1e-05|TWO_SIDED|95.0|0.41|0.59|||Log Rank||Based on Cox regression model with treatment as a covariate stratified by PD-L1 status (≥1% vs. \<1%), platinum chemotherapy (cisplatin vs. carboplatin) \& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.|||0.59|0.41|<0.00001
71116577|NCT00664560|141739602|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority (NI) margin of 10mm between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|-0.22|||||TWO_SIDED|95.0|-4.76|4.32|||ANCOVA|||||4.32|-4.76|
71116578|NCT00664560|141739603|NON_INFERIORITY_OR_EQUIVALENCE|10 mm Non-Inferiority (NI) margin between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|-0.09|||||TWO_SIDED|95.0|-4.57|4.38|||ANCOVA|||||4.38|-4.57|
71116579|NCT00664560|141739604|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority (NI) margin 10 mm between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|-0.47|||||TWO_SIDED|95.0|-5.08|4.14|||ANCOVA|||||4.14|-5.08|
71116580|NCT03576066|141739619|OTHER|||||||0.6855|||||||Repeated measures analysis|||Least squares (LS) mean difference in HBeAg-positive participants: ABI-H0731 + SOC NUC minus placebo + SOC NUC at Week 24||||0.6855
71116581|NCT03576066|141739619|OTHER|||||||0.175|||||||Repeated measures analysis|||LS mean difference in HBeAg-negative participants: ABI-H0731 + SOC NUC minus placebo + SOC NUC at Week 24||||0.1750
71116582|NCT03576066|141739620|OTHER|||||||0.2916|||||||Repeated measures analysis|||Least squares (LS) mean difference in HBeAg-positive participants: ABI-H0731 + SOC NUC minus placebo + SOC NUC at Week 24||||0.2916
71116583|NCT02642393|141739648|OTHER||Slope|1.256|STANDARD_ERROR_OF_MEAN|0.943||0.183|TWO_SIDED|95.0|-0.594|3.106|||Mixed Models Analysis|||||3.106|-0.594|0.183
71116584|NCT02642393|141739649|OTHER||Rate Ratio|1.08||||0.124|TWO_SIDED|95.0|0.979|1.192|||Poisson Regression|||||1.192|0.979|0.124
71116585|NCT02642393|141739650|OTHER||Rate Ratio|1.154||||0.004|TWO_SIDED|95.0|1.046|1.273|||Poisson Regression|||||1.273|1.046|0.004
71116586|NCT02642393|141739651|OTHER|||||||0.002|||||||Log Rank|||||||0.002
71116587|NCT02642393|141739652|OTHER|||||||0.497|||||||Log Rank|||||||0.497
71116588|NCT02642393|141739653|OTHER||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.385||0.856|TWO_SIDED|95.0|-0.825|0.685|||Mixed Models Analysis|||||0.685|-0.825|0.856
71116589|NCT02642393|141739654|OTHER||Slope|0.076|STANDARD_ERROR_OF_MEAN|0.226||0.736|TWO_SIDED|95.0|-0.368|0.521|||Mixed Models Analysis|||Anxiety||0.521|-0.368|0.736
70940917|NCT02592434|141381806|SUPERIORITY||Difference in percentage|-1.15||||0.8119|TWO_SIDED|95.0|-10.63|8.33|||Normal approximation for binomial|||Double Blind Baseline (Week 18)||8.33|-10.63|0.8119
70940918|NCT02592434|141381806|SUPERIORITY||Difference in percentage|7.66||||0.2682|TWO_SIDED|95.0|-5.9|21.21|||Normal approximation for binomial|||Week 20||21.21|-5.90|0.2682
70940919|NCT02592434|141381806|SUPERIORITY||Difference in percentage|21.98||||0.0034|TWO_SIDED|95.0|7.26|36.71|||Normal approximation for binomial|||Week 24||36.71|7.26|0.0034
70940920|NCT02592434|141381806|SUPERIORITY||Difference in percentage|17.9||||0.0233|TWO_SIDED|95.0|2.44|33.36|||Normal approximation for binomial|||Week 28||33.36|2.44|0.0233
71116590|NCT02642393|141739654|OTHER||Slope|0.295|STANDARD_ERROR_OF_MEAN|0.213||0.167|TWO_SIDED|95.0|-0.124|0.714|||Mixed Models Analysis|||Cognitive Function||0.714|-0.124|0.167
71116591|NCT02642393|141739654|OTHER||Slope|0.256|STANDARD_ERROR_OF_MEAN|0.111||0.022|TWO_SIDED|95.0|0.038|0.474|||Mixed Models Analysis|||Communication||0.474|0.038|0.022
71116592|NCT02642393|141739654|OTHER||Slope|0.095|STANDARD_ERROR_OF_MEAN|0.173||0.584|TWO_SIDED|95.0|-0.245|0.435|||Mixed Models Analysis|||Emotional and Behavioral Dyscontrol||0.435|-0.245|0.584
71116593|NCT02642393|141739654|OTHER||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.28||0.973|TWO_SIDED|95.0|-0.56|0.541|||Mixed Models Analysis|||Fatigue||0.541|-0.560|0.973
71116594|NCT02642393|141739654|OTHER||Slope|0.169|STANDARD_ERROR_OF_MEAN|0.136||0.214|TWO_SIDED|95.0|-0.098|0.437|||Mixed Models Analysis|||Lower Extremity Function||0.437|-0.098|0.214
71116595|NCT02642393|141739654|OTHER||Slope|-0.334|STANDARD_ERROR_OF_MEAN|0.304||0.271|TWO_SIDED|95.0|-0.931|0.262|||Mixed Models Analysis|||Positive Affect and Well-Being||0.262|-0.931|0.271
71116596|NCT02642393|141739654|OTHER||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.566|TWO_SIDED|95.0|-0.355|0.194|||Mixed Models Analysis|||Stigma||0.194|-0.355|0.566
71116597|NCT02642393|141739654|OTHER||Slope|0.212|STANDARD_ERROR_OF_MEAN|0.14||0.13|TWO_SIDED|95.0|-0.063|0.487|||Mixed Models Analysis|||Upper Extremity Function||0.487|-0.063|0.130
71116598|NCT02642393|141739654|OTHER||Slope|0.072|STANDARD_ERROR_OF_MEAN|0.202||0.723|TWO_SIDED|95.0|-0.325|0.468|||Mixed Models Analysis|||Sleep Disturbance||0.468|-0.325|0.723
71116599|NCT02642393|141739654|OTHER||Slope|-0.006|STANDARD_ERROR_OF_MEAN|0.298||0.984|TWO_SIDED|95.0|-0.592|0.579|||Mixed Models Analysis|||Satisfaction with Social Roles and Activities||0.579|-0.592|0.984
71116600|NCT02642393|141739654|OTHER||Slope|-0.253|STANDARD_ERROR_OF_MEAN|0.317||0.426|TWO_SIDED|95.0|-0.877|0.371|||Mixed Models Analysis|||Participation in Social Roles and Activities||0.371|-0.877|0.426
71116601|NCT02642393|141739655|OTHER||Slope|-0.106|STANDARD_ERROR_OF_MEAN|0.141||0.454|TWO_SIDED|95.0|-0.382|0.171|||Mixed Models Analysis|||||0.171|-0.382|0.454
71116602|NCT02642393|141739656|OTHER||Slope|0.047|STANDARD_ERROR_OF_MEAN|0.413||0.91|TWO_SIDED|95.0|-0.764|0.858|||Mixed Models Analysis|||||0.858|-0.764|0.910
71116603|NCT02642393|141739657|OTHER||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.13||0.758|TWO_SIDED|95.0|-0.295|0.215|||Mixed Models Analysis|||||0.215|-0.295|0.758
71116604|NCT02642393|141739658|OTHER||Slope|-0.208|STANDARD_ERROR_OF_MEAN|0.803||0.796|TWO_SIDED|95.0|-1.783|1.367|||Mixed Models Analysis|||BL to V01||1.367|-1.783|0.796
71116605|NCT02642393|141739658|OTHER||Slope|-2.4|STANDARD_ERROR_OF_MEAN|3.443||0.486|TWO_SIDED|95.0|-9.156|4.355|||Mixed Models Analysis|||V10 to SV||4.355|-9.156|0.486
70940921|NCT02592434|141381806|SUPERIORITY||Difference in percentage|25.16||||0.0018|TWO_SIDED|95.0|9.39|40.93|||Normal approximation for binomial|||Week 32||40.93|9.39|0.0018
70940922|NCT02592434|141381806|SUPERIORITY||Difference in percentage|20.91||||0.0099|TWO_SIDED|95.0|5.01|36.81|||Normal approximation for binomial|||Week 36||36.81|5.01|0.0099
71076017|NCT03334422|141660617|SUPERIORITY||LSMean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|0.05|0.17|||Mixed Models Analysis|||Health State Index Score (UK Algorithm)||0.17|0.05|<0.001
71076018|NCT03334422|141660618|SUPERIORITY||LSMean Difference|0.4|STANDARD_ERROR_OF_MEAN|3.47||0.907|TWO_SIDED|95.0|-6.44|7.25|||Mixed Models Analysis|||EQ-5D-5L VAS Score||7.25|-6.44|0.907
70940923|NCT02592434|141381806|SUPERIORITY||Difference in percentage|22.34||||0.0058|TWO_SIDED|95.0|6.46|38.22|||Normal approximation for binomial|||Week 40||38.22|6.46|0.0058
70940924|NCT02592434|141381808|SUPERIORITY||Difference in percentage|3.77||||0.6348|TWO_SIDED|95.0|-11.79|19.33|||Normal approximation to the binomial|||Double Blind Baseline (Week 18)||19.33|-11.79|0.6348
70940925|NCT02592434|141381808|SUPERIORITY||Difference in percentage|2.62||||0.7525|TWO_SIDED|95.0|-13.66|18.9|||Normal approximation to the binomial|||Week 20||18.90|-13.66|0.7525
71076019|NCT03334422|141660618|SUPERIORITY||LSMean Difference|8.19|STANDARD_ERROR_OF_MEAN|3.33||0.015|TWO_SIDED|95.0|1.63|14.76|||Mixed Models Analysis|||EQ-5D-5L VAS Score||14.76|1.63|0.015
71076020|NCT03334422|141660618|SUPERIORITY||LSMean Difference|8.82|STANDARD_ERROR_OF_MEAN|3.14||0.006|TWO_SIDED|95.0|2.62|15.01|||Mixed Models Analysis|||EQ-5D-5L VAS Score||15.01|2.62|0.006
71076021|NCT03334422|141660619|SUPERIORITY||Odds Ratio (OR)|0.93||||0.905|TWO_SIDED|95.0|0.3|2.93|||Regression, Logistic|||||2.93|0.30|0.905
71076022|NCT03334422|141660619|SUPERIORITY||Odds Ratio (OR)|2.37||||0.064|TWO_SIDED|95.0|0.95|5.92|||Regression, Logistic|||||5.92|0.95|0.064
71076023|NCT03334422|141660619|SUPERIORITY||Odds Ratio (OR)|5.14|||<|0.001|TWO_SIDED|95.0|2.25|11.74|||Regression, Logistic|||||11.74|2.25|<0.001
71076024|NCT01313221|141660621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.16|STANDARD_ERROR_OF_MEAN|9.99|||TWO_SIDED|95.0|-3.5|35.82|||||Adjusted for treatment in a mixed model|||35.82|-3.50|
70940926|NCT02592434|141381808|SUPERIORITY||Difference in percentage|14.05||||0.0908|TWO_SIDED|95.0|-2.23|30.33|||Normal approximation to the binomial|||Week 24||30.33|-2.23|0.0908
70940927|NCT02592434|141381808|SUPERIORITY||Difference in percentage|7.02||||0.4026|TWO_SIDED|95.0|-9.38|23.43|||Normal approximation to the binomial|||Week 28||23.43|-9.38|0.4026
70940928|NCT02592434|141381808|SUPERIORITY||Difference in percentage|18.37||||0.0258|TWO_SIDED|95.0|2.22|34.52|||Normal approximation to the binomial|||Week 32||34.52|2.22|0.0258
70940929|NCT02592434|141381808|SUPERIORITY||Difference in percentage|19.88||||0.0149|TWO_SIDED|95.0|3.88|35.88|||Normal approximation to the binomial|||Week 36||35.88|3.88|0.0149
70940930|NCT02592434|141381808|SUPERIORITY||Difference in percentage|19.88||||0.0149|TWO_SIDED|95.0|3.88|35.88|||Normal approximation to the binomial|||Week 40||35.88|3.88|0.0149
70940931|NCT02592434|141381810|SUPERIORITY||Difference in percentage|-5.24||||0.515|TWO_SIDED|95.0|-21.0|10.53|||Normal approximation to the binomial|||Double Blind Baseline (Week 18)||10.53|-21.00|0.5150
71076025|NCT01313221|141660622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.23|STANDARD_ERROR_OF_MEAN|8.31|||TWO_SIDED|95.0|-5.13|27.6||||||Difference in change from Week 12 to Week 16||27.60|-5.13|
71076026|NCT01313221|141660622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.56|STANDARD_ERROR_OF_MEAN|9.53|||TWO_SIDED|95.0|-2.21|35.32||||||Difference in change from Week 12 to Week 20||35.32|-2.21|
71076027|NCT00135356|141660716|SUPERIORITY_OR_OTHER||Difference in Means|0.03||||0.48||95.0|-0.06|0.12||P-value not adjusted for multiple testing, 2-sided 95% CI|t-test, 2 sided|||LOCF||0.12|-0.06|0.48
71076028|NCT00135356|141660716|SUPERIORITY_OR_OTHER||Difference in Means|0.07||||0.57||95.0|-0.07|12.0||P-value not adjusted for multiple testing. 2-sided 95% CI|t-test, 2 sided|||OC||12.0|-0.07|0.57
71076029|NCT00135356|141660717|SUPERIORITY_OR_OTHER||Difference in Means|0.02||||0.73||95.0|-0.1|0.14||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||LOCF||0.14|-0.10|0.73
71076030|NCT00135356|141660717|SUPERIORITY_OR_OTHER||Difference in Means|-0.01||||0.91||95.0|-0.14|0.13||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||OC||0.13|-0.14|0.91
71076031|NCT00135356|141660718|SUPERIORITY_OR_OTHER||Difference in Mean|5.2||||0.27||95.0|-3.9|15.1||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 48 VAT LOCF||15.1|-3.9|0.27
71076032|NCT00135356|141660718|SUPERIORITY_OR_OTHER||Difference in Mean|1.8||||0.68||95.0|-6.7|11.2||P-value not adjusted for multiple testing, 2-sided 95% CI|t-test, 2 sided|||VAT, Week 96 LOCF||11.2|-6.7|0.68
71076033|NCT00135356|141660718|SUPERIORITY_OR_OTHER||Difference in Means|4.4||||0.14||95.0|-1.4|10.6||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 48 Trunk Fat LOCF||10.6|-1.4|0.14
71076034|NCT00135356|141660718|SUPERIORITY_OR_OTHER||Difference in Means|5.3||||0.14||95.0|-1.7|12.9||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 96 Trunk Fat LOCF||12.9|-1.7|0.14
71076035|NCT00135356|141660719|SUPERIORITY_OR_OTHER||Difference in Means|4.0||||0.16||95.0|-1.6|10.0||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||SAT, Week 48, LOCF||10.0|-1.6|0.16
71076036|NCT00135356|141660719|SUPERIORITY_OR_OTHER||Difference in Mean|6.8||||0.06||95.0|-0.2|14.2||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 96 SAT||14.2|-0.2|0.06
71076037|NCT00135356|141660719|SUPERIORITY_OR_OTHER||Difference in Means|4.6||||0.15||95.0|-1.7|11.4||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 48, Limb Fat||11.4|-1.7|0.15
71076038|NCT00135356|141660719|SUPERIORITY_OR_OTHER||Difference in Means|5.7||||0.17||95.0|-2.3|14.4||P-value not adjusted for multiple testing, 2-sided 95% CI|t-test, 2 sided|||Week 96, Limb Fat||14.4|-2.3|0.17
71076039|NCT00135356|141660720|SUPERIORITY_OR_OTHER||DIfference in Means|3.6||||0.19||95.0|-1.8|9.4||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 48 TAT||9.4|-1.8|0.19
71076040|NCT00135356|141660720|SUPERIORITY_OR_OTHER||DIfference in Means|4.3||||0.16||95.0|-1.7|10.7||P-value not adjusted for multiple testing, 2-sided 95% CI.|Wilcoxon (Mann-Whitney)|||Week 96 TAT||10.7|-1.7|0.16
71076041|NCT00135356|141660720|SUPERIORITY_OR_OTHER||Difference in Means|5.0||||0.0385||95.0|0.3|9.7||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 48 Total Body Fat||9.7|0.3|0.0385
70940932|NCT02592434|141381810|SUPERIORITY||Difference in percentage|9.01||||0.24||95.0|-6.02|24.03|||Normal approximation to the binomial|||Week 20||24.03|-6.02|0.2400
71116606|NCT00365105|141739671|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04||||0.844|TWO_SIDED|95.0|0.7|1.54|||Log Rank|||Assuming an exponential distribution, the weighted yearly SRE hazard rate for patients treated with bisphosphonates only is 0.7991 which translates to a median time to SRE of 10.4 months. The study was designed to show a 33% relative reduction in the yearly SRE hazard rate, i.e. 15.6 months median time to SRE. Using a two-sided log-rank test assuming a type I error of 0.05, one planned interim analysis with 90% statistical power, 257 SREs are required with a total of 316 patients.||1.54|0.70|0.844
71116607|NCT00365105|141739672|SUPERIORITY|The power of detecting an improvement from 55% in the control arm to 41% in the experimental arm with a two-sided Fisher's exact test at alpha 0.05 is 66%.||||||0.26|||||||Fisher Exact|||||||0.26
71116608|NCT00365105|141739673|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.37|TWO_SIDED|95.0|0.86|1.52|||Log Rank|||Assuming the disease site distribution is 40%, 40%, and 20% from prostate, breast, and lung cancer populations, respectively, the weighted yearly death rate for patients treated with bisphosphonates only is 0.4390, translating to a median overall survival time of 18.9 months assuming an exponential distribution. Statistical power to detect a relative difference of 33% in the yearly death rate is 70% using a two-sided log-rank test at a 0.05 significance level and 87% to detect 50% difference.||1.52|0.86|0.37
71116609|NCT00365105|141739674|SUPERIORITY|||||||0.96||||||Two-sided significance level of 0.01|Wilcoxon (Mann-Whitney)|||FACT-G Total||||0.96
71116610|NCT00365105|141739674|SUPERIORITY|||||||0.97||||||Two-sided significance level of 0.01|Wilcoxon (Mann-Whitney)|||Physical Well-Being||||0.97
71116611|NCT00365105|141739674|SUPERIORITY|||||||0.57||||||Two-sided significance level of 0.01|Wilcoxon (Mann-Whitney)|||Social/Family Well-Being||||0.57
71116612|NCT00365105|141739674|SUPERIORITY|||||||0.7||||||Two-sided significance level of 0.01|Wilcoxon (Mann-Whitney)|||Emotional Well-Being||||0.70
71116613|NCT00365105|141739674|SUPERIORITY|||||||0.46||||||Two-sided significance level of 0.01|Wilcoxon (Mann-Whitney)|||Functional Well-Being||||0.46
71116614|NCT00365105|141739675|SUPERIORITY|||||||0.99||||||2-sided significance level of 0.05|Wilcoxon (Mann-Whitney)|||||||0.99
71116615|NCT00365105|141739676|SUPERIORITY|||||||0.43||||||Significance level of 0.05|t-test, 2 sided|||Index Score||||0.43
71116616|NCT00365105|141739676|SUPERIORITY|||||||0.15||||||Significance level of 0.05|t-test, 2 sided|||VAS Score||||0.15
71116617|NCT04478071|141739699|SUPERIORITY||Risk Difference (RD)|-0.036|||||TWO_SIDED|95.0|-0.084|0.009|||||"Risk difference of Vadadustat relative to Placebo. Values under confidence interval reflect Bayesian 95% credible interval rather than frequentist confidence interval."|Trial used Bayesian analysis for superiority. Hypothesis Testing for Primary Outcome: Among adult hospital admissions with lab-confirmed diagnosis of COVID-19, vadadustat 900 mg will demonstrate superiority to placebo as defined by a lower probability, at treatment day 14, of death (8) or hospitalization, on invasive mechanical ventilation or ECMO (7) or hospitalization, on non-invasive ventilation or high flow oxygen devices (6) on the NIAID-OS. See Statistical Analysis Plan for more details.||0.009|-0.084|
71116618|NCT04478071|141739699|SUPERIORITY||Posterior Probability|0.94|||||TWO_SIDED||||||||Posterior probability of the risk difference of Vadadustat relative to Placebo.|||||
71116619|NCT04478071|141739700|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.92|1.1|||||"Risk ratio of Vadadustat relative to Placebo. Values under confidence interval reflect Bayesian 95% credible interval rather than frequentist confidence interval."|Trial used Bayesian analysis for superiority. Hypothesis Testing for Secondary Outcome: Among adult hospital admissions with lab-confirmed diagnosis of COVID-19, vadadustat 900 mg will demonstrate superiority to placebo as defined by a higher probability, at treatment day 14, of recovery on the MSOFA scale (MSOFA = 0).||1.1|0.92|
70940933|NCT02592434|141381810|SUPERIORITY||Difference in percentage|8.93||||0.2557|TWO_SIDED|95.0|-6.47|24.33|||Normal approximation to the binomial|||Week 24||24.33|-6.47|0.2557
71116620|NCT04478071|141739700|SUPERIORITY||Posterior probability|0.57|||||TWO_SIDED||||||||Posterior probability of the risk ratio of Vadadustat relative to Placebo.|||||
71116621|NCT06053541|141739712|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||0.24
71116622|NCT06053541|141739713|OTHER|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||0.37
71116623|NCT06053541|141739714|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||0.03
71116624|NCT06053541|141739715|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Beds in the general practice and Pulmonology: For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||0.11
71116625|NCT06053541|141739715|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Beds in Adults ICU: For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||<0.01
71116626|NCT06053541|141739716|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||0.01
71116627|NCT06053541|141739717|OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||0.07
71116628|NCT00245050|141739718|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07|||<|0.05|TWO_SIDED|95.0|0.536|2.16|||Chi-squared|||Based on published literature, it is estimated that the incidence of HFS for all grades is 49%. A decrease of 50% or more in the incidence of HFS in patients receiving pyridoxine would be of clinical significance. A sample size of 27 patients per group was chosen as this would allow us to detect a difference between HFS incidence of 49% and 11.5% (alpha=0.05, two-sided, power=0.80). Interim analysis was conducted after 30 patients were enrolled and had evaluable HFS assessment data.||2.16|0.536|<0.05
70940934|NCT02592434|141381810|SUPERIORITY||Difference in percentage|8.97||||0.2481|TWO_SIDED|95.0|-6.25|24.19|||Normal approximation to the binomial|||Week 28||24.19|-6.25|0.2481
71116629|NCT00245050|141739719|SUPERIORITY_OR_OTHER|||||||0.916||95.0|||||t-test, 2 sided|||||||0.916
71076042|NCT00135356|141660720|SUPERIORITY_OR_OTHER||Difference in Means|5.9||||0.1||95.0|-1.0|13.2||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 96 Total Body Fat||13.2|-1.0|0.10
71076043|NCT00135356|141660732|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.3|3.72||||||||3.72|0.3|
71076044|NCT00253370|141660750|SUPERIORITY_OR_OTHER||proportion of participants|0.409||||0.0012|TWO_SIDED|90.0|0.284|0.544|||one-sample binomial test|||The study was designed to distinguish a response rate of 40% from 20%, the null hypothesis. With the planned sample size of 36 eligible patients, the study has 91% power based on a 0.09 level one-sided test.||0.544|0.284|0.0012
71076045|NCT01211483|141660783|SUPERIORITY||Hazard Ratio (HR)|0.978|||||TWO_SIDED|95.0|0.674|1.42||||||||1.420|0.674|
71076046|NCT01211483|141660783|SUPERIORITY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.523|1.131||||||||1.131|0.523|
71076047|NCT01211483|141660784|SUPERIORITY||Hazard Ratio (HR)|0.369||||0.0185|TWO_SIDED|95.0|0.161|0.846|||Cox proportional hazard|||||0.846|0.161|0.0185
71076048|NCT01211483|141660784|SUPERIORITY||Hazard Ratio (HR)|0.288||||0.0034|TWO_SIDED|95.0|0.125|0.663|||Cox proportional hazard|||||0.663|0.125|0.0034
71076049|NCT01211483|141660785|SUPERIORITY||Hazard Ratio (HR)|1.006||||0.9879|TWO_SIDED|95.0|0.458|2.212|||Cox proportional hazard|||||2.212|0.458|0.9879
71076050|NCT01211483|141660785|SUPERIORITY||Hazard Ratio (HR)|1.222||||0.6276|TWO_SIDED|95.0|0.544|2.746|||Cox proportional hazard|||||2.746|0.544|0.6276
71076051|NCT04245202|141660823|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70940935|NCT02592434|141381810|SUPERIORITY||Difference in percentage|16.03||||0.0356|TWO_SIDED|95.0|1.08|30.98|||Normal approximation to the binomial|||Week 32||30.98|1.08|0.0356
71076052|NCT04245202|141660824|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71076053|NCT04245202|141660825|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71076054|NCT04245202|141660826|OTHER||Mean Difference (Net)|-12.29|STANDARD_DEVIATION|5.72|<|0.001|TWO_SIDED|95.0|-23.53|-1.05||The p-Value of the interaction between time and groups was given. In all analyses, p values \<0·05 were considered being statistically significant.|Mixed Models Analysis||Treatment difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)|||-1.05|-23.53|<0.001
71076055|NCT04245202|141660827|OTHER||Mean Difference (Net)|-12.66|STANDARD_DEVIATION|4.77|<|0.001|TWO_SIDED|95.0|-22.05|-3.28|||Mixed Models Analysis||Treatment difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)|The p-Value of the interaction between time and groups was given. In all analyses, p values \<0·05 were considered being statistically significant.||-3.28|-22.05|<0.001
71076056|NCT04245202|141660828|OTHER||Mean Difference (Net)|-3.91|STANDARD_DEVIATION|2.43|<|0.001|TWO_SIDED|95.0|-8.68|0.86||The p-Value of the interaction between time and groups was given. In all analysis, p values \<0.05 were considered being statistically significant.|Mixed Models Analysis||Treatment difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)|||0.86|-8.68|<0.001
71076057|NCT04245202|141660829|OTHER||Mean Difference (Net)|-2.41|STANDARD_DEVIATION|2.14||0.003|TWO_SIDED|95.0|-6.62|1.78|||Mixed Models Analysis||Treatment difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)|The p-Value of the interaction between time and groups was given. In all analysis, p values \<0.05 were considered being statistically significant.||1.78|-6.62|0.003
71076058|NCT04245202|141660830|OTHER||Relative treatment effect difference|-0.07||||0.002|TWO_SIDED|||||The p-Value of the interaction between time and groups was given. In all analysis, p values \<0.05 were considered being statistically significant.|Brunner-Langer Method||Relative Treatment Effect Difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)|||||0.002
71076059|NCT04245202|141660831|OTHER||Relative treatment effect difference|-0.08||||0.001|TWO_SIDED|95.0||||The p-Value of the interaction between time and groups was given. In all analysis, p values \<0.05 were considered being statistically significant.|Brunner-Langer Method||Relative Treatment Effect Difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)|||||0.001
71076060|NCT04245202|141660833|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
71076061|NCT04245202|141660834|OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
71076062|NCT04245202|141660835|OTHER|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||||||0.99
71076063|NCT04245202|141660836|OTHER|||||||0.02|||||||Fisher Exact|||||||0.02
71076064|NCT04245202|141660837|OTHER|||||||0.02|||||||Fisher Exact|||||||0.02
71076065|NCT04245202|141660838|OTHER|||||||0.08|||||||Fisher Exact|||||||0.08
71076066|NCT02470403|141660839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-5.7|||<|0.001|TWO_SIDED|80.0|-6.52|-4.87|||Mixed Models Analysis|||"This analysis included all subjects. The following criteria were assessed:~1. upper confidence limit of the 80% CI for treatment difference (LIK066 - placebo) was less than 0, and~2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%."||-4.87|-6.52|<0.001
71076067|NCT02470403|141660839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.85|||<|0.001|TWO_SIDED|80.0|-7.96|-5.73|||Mixed Models Analysis|||"This analysis included dysglycemic subjects. The following criteria were assessed:~1. upper confidence limit of 80% CI for treatment difference was less than 0, and~2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%."||-5.73|-7.96|<0.001
71076068|NCT02470403|141660839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.55|||<|0.001|TWO_SIDED|80.0|-5.76|-3.34|||Mixed Models Analysis|||"This analysis included normoglycemic subjects. The following criteria were assessed:~1. upper confidence limit of 80% CI for treatment difference was less than 0, and~2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%."||-3.34|-5.76|<0.001
71116630|NCT01843673|141739720|NON_INFERIORITY_OR_EQUIVALENCE|Statistical significance testing at 5% level of significance, p-value being larger than 0.05 . The p-values for pairwise comparison.||||||1||||||Statistical significance testing at 5% level of significance, p-value being larger than 0.05. The p-values for pairwise comparison lateral and vertical, for OBI and CBCT was 1.00.|t-test, 2 sided|||Pairwise comparison for each direction between each pair of technologies were done using a t test to check if the difference in the recommended shift is more than 2 mm. Clinical significance is based on a 2 mm difference. Statistical significance is determined based on 5% level of significance.||||1.00
71116631|NCT01843673|141739720|NON_INFERIORITY_OR_EQUIVALENCE|Statistical significance testing at 5% level of significance, p-value being larger than 0.05. Those are the p-values for pairwise comparison.||||||1||||||Statistical significance testing at 5% level of significance, p-value being larger than 0.05. The p-values for pairwise comparison lateral and vertical, for OBI and ExacTrac was 1.00.|t-test, 2 sided|||Pairwise comparison for each direction between each pair of technologies were done using a t test to check if the difference in the recommended shift is more than 2 mm. Clinical significance is based on a 2 mm difference. Statistical significance is determined based on 5% level of significance.||||1.00
71116632|NCT00425698|141739723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|STANDARD_DEVIATION|15.0|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Null hypothesis: Erythopoietin significantly improves kidney graft function. Power calculation: with a difference of at least 4 mL/min in mean eGFR between groups the number of patients enrolled per group (at least 41) would allowed the detection of a significant difference between groups at a 5% level (p\<0.05)||||<0.05
71076069|NCT02470403|141660841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.83|||<|0.001|TWO_SIDED|80.0|-2.16|-1.51|||Mixed Models Analysis|||"This analysis on all subjects. The following criteria were assessed:~1. upper confidence limit of 80% CI for treatment difference was less than 0, and~2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%."||-1.51|-2.16|<0.001
71076070|NCT02470403|141660841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.39|||<|0.001|TWO_SIDED|80.0|-2.94|-1.84|||Mixed Models Analysis|||"This analysis on all subjects. The following criteria were assessed:~1. upper confidence limit of 80% CI for treatment difference was less than 0, and~2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%."||-1.84|-2.94|<0.001
71076071|NCT02470403|141660841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.38|||<|0.001|TWO_SIDED|80.0|-2.93|-1.83|||Mixed Models Analysis|||"This analysis on all subjects. The following criteria were assessed:~1. upper confidence limit of 80% CI for treatment difference was less than 0, and~2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%"||-1.83|-2.93|<0.001
71076072|NCT00904839|141660869|SUPERIORITY_OR_OTHER||Difference|-8.1|||||TWO_SIDED|95.0|-27.8|11.5|||Kaplan-Meier||Difference in Kaplan-Meier Progression-free Survival Rates at 9 Months using Peto´s variance estimate.|||11.5|-27.8|
71076073|NCT00904839|141660874|SUPERIORITY_OR_OTHER||Difference|-5.0|||||TWO_SIDED|95.0|-15.3|5.2|||Kaplan-Meier||confidence interval includes 0, meaning that the null hypothesis (no difference between the 2 groups) cannot be rejected (i.e. pvalue \> 0.05). The pvalue was not computed. Difference in Kaplan-Meier Resection Rates using Peto´s variance estimate.|||5.2|-15.3|
71076074|NCT01430624|141660885|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED|||||6 month follow-up comparison|ANOVA|df 2, 109||||||.24
71076075|NCT01430624|141660886|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED|||||6 month follow-up comparison|ANOVA|df = 2, 111||||||.89
71076076|NCT01430624|141660887|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||6 week comparison|ANOVA|df = 2, 150||||||.01
71076077|NCT01430624|141660887|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||3 month comparison|ANOVA|||||||.48
71076078|NCT01430624|141660887|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|||||6 month comparison|ANOVA|||||||.17
71076079|NCT01430624|141660888|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED|||||6 week comparison|Chi-squared|df = 2, 154||||||.37
71076080|NCT01430624|141660888|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED|||||3 month comparison|Chi-squared|df = 2, 135||||||.15
71076081|NCT01430624|141660888|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED|||||6 month comparison|Chi-squared|df = 2, 121||||||.87
71076082|NCT01430624|141660889|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED|||||6 week comparison|ANOVA|df = 2, 150||||||.63
71076083|NCT01430624|141660889|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED|||||3 month comparison|ANOVA|df = 2, 132||||||.25
71076084|NCT01430624|141660889|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|||||6 month comparison|ANOVA|df = 2, 118||||||.59
71076085|NCT01430624|141660890|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|||||6 week comparison|ANOVA|df = 2, 151||||||.83
71076086|NCT01430624|141660890|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED|||||3 month comparison|ANOVA|df = 2, 132||||||.29
71076087|NCT01430624|141660890|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED|||||6 month comparison|ANOVA|df = 2, 118||||||.13
71076088|NCT01430624|141660891|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||6 week comparison|ANOVA|df = 2, 151||||||.012
71076089|NCT01430624|141660891|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED|||||3 month comparison|ANOVA|df = 2, 132||||||.31
71076090|NCT01430624|141660891|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED|||||6 month comparison|ANOVA|df = 2,116||||||.35
71076091|NCT01430624|141660892|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED|||||6 week comparison|ANOVA|df = 2, 141||||||.15
71076092|NCT01430624|141660892|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED|||||3 month comparison|ANOVA|df = 2, 127||||||.67
71076093|NCT01430624|141660892|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED|||||6 month comparison|ANOVA|df = 2, 110||||||.40
71076094|NCT00553358|141660903|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants with pCR|-4.85||||0.3416|TWO_SIDED|97.5|-17.6|8.16|||Binomial|Binomial p-value for Trastuzumab 2 mg/kg versus Lapatinib 1500 mg|Estimation Comments: Estimated value is the difference in the percentage of participants with pCR: Arm1 (Lapatinib 1500 mg) minus Arm2 (Trastuzumab 2 mg/kg).|||8.16|-17.6|0.3416
71076095|NCT00553358|141660903|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants with pCR|21.79||||0.0001|TWO_SIDED|97.5|9.08|34.23|||Binomial|Binomial p-value for Trastuzumab 2 mg/kg versus Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Estimation Comments: Estimated value is the difference in the percentage of participants with pCR: Arm3 (Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg) minus Arm2 (Trastuzumab 2 mg/kg)|||34.23|9.08|0.0001
71076096|NCT00553358|141660911|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.878||||0.548|TWO_SIDED|95.0|0.57|1.34||The two-sided stratified log-rank test was implemented as the score test from the Cox model.|Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate hazard ratios and corresponding confidence intervals for the pairwise comparisons of individual treatment arms with the trastuzumab alone arm.|||1.34|0.57|0.548
70940936|NCT02592434|141381810|SUPERIORITY||Difference in percentage|18.89||||0.0115|TWO_SIDED|95.0|4.24|33.54|||Normal approximation to the binomial|||Week 36||33.54|4.24|0.0115
70940937|NCT02592434|141381810|SUPERIORITY||Difference in percentage|11.87||||0.115|TWO_SIDED|95.0|-2.89|26.62|||Normal approximation to the binomial|||Week 40||26.62|-2.89|0.1150
70940938|NCT02592434|141381810|SUPERIORITY||Difference in percentage|13.29||||0.0744|TWO_SIDED|95.0|-1.31|27.9|||Normal approximation to the binomial|||Week 44||27.90|-1.31|0.0744
70853684|NCT00759564|141195497|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|248.38|||||TWO_SIDED|90.0|202.98|303.94||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||303.94|202.98|
70940939|NCT02592434|141381812|SUPERIORITY||Difference in percentage|-16.15||||0.0207|TWO_SIDED|95.0|-29.84|-2.46|||Normal approximation to the binomial|||Double Blind Baseline (Week 18)||-2.46|-29.84|0.0207
70940940|NCT02592434|141381812|SUPERIORITY||Difference in percentage|10.63||||0.1254|TWO_SIDED|95.0|-2.97|24.24|||Normal approximation to the binomial|||Week 20||24.24|-2.97|0.1254
70940941|NCT02592434|141381812|SUPERIORITY||Difference in percentage|3.49||||0.635|TWO_SIDED|95.0|-10.93|17.91|||Normal approximation to the binomial|||Week 24||17.91|-10.93|0.6350
70940942|NCT02592434|141381812|SUPERIORITY||Difference in percentage|2.1||||0.7732|TWO_SIDED|95.0|-12.2|16.41|||Normal approximation to the binomial|||Week 28||16.41|-12.20|0.7732
70940943|NCT02592434|141381812|SUPERIORITY||Difference in percentage|6.35||||0.3782|TWO_SIDED|95.0|-7.77|20.47|||Normal approximation to the binomial|||Week 32||20.47|-7.77|0.3782
70940944|NCT02592434|141381812|SUPERIORITY||Difference in percentage|11.98||||0.0936|TWO_SIDED|95.0|-2.02|25.99|||Normal approximation to the binomial|||Week 36||25.99|-2.02|0.0936
70940945|NCT02592434|141381812|SUPERIORITY||Difference in percentage|9.17||||0.2017|TWO_SIDED|95.0|-4.91|23.24|||Normal approximation to the binomial|||Week 40||23.24|-4.91|0.2017
71076097|NCT00553358|141660911|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.005||||0.981|TWO_SIDED|95.0|0.66|1.52||The two-sided stratified log-rank test was implemented as the score test from the Cox model.|Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate hazard ratios and corresponding confidence intervals for the pairwise comparisons of individual treatment arms with the trastuzumab alone arm.|||1.52|0.66|0.981
71116633|NCT02516098|141739752|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the test and reference product (for Stage 1) was assessed on the basis of the point estimate of the geometric mean ratio for Cmax in relation to the bioequivalence range of 80.00% to 125.00%.|Geometric mean ratio (%): T/REF|87.52|||||TWO_SIDED|92.46|77.18|99.24|||||ANOVA model was used with 'sequence', 'treatment' and 'period' as fixed effects and 'subject within sequence' as a random effect after logarithmic transformation of the data.|The study design is a two-stage Pocock-like group sequential design according to the alpha spending function approach. The alpha level for Stage 1 was 0.0377 (one-sided).||99.24|77.18|
71116634|NCT02516098|141739753|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the test and reference products for Stage 1 was assessed on the basis of the 92.46% confidence intervals for the geometric mean (test/reference) ratio for the AUC0-t in relation to the bioequivalence range of 80.00% to 125.00%, with a one-sided alpha of 0.0377.|Geometric mean ratio (%): T/REF|91.74|||||TWO_SIDED|92.46|83.51|100.78|||||ANOVA model was used with 'sequence', 'treatment' and 'period' as fixed effects and 'subject within sequence' as a random effect after logarithmic transformation of the data.|The study design is a two-stage Pocock-like group sequential design according to the alpha spending function approach. The alpha level for Stage 1 was 0.0377 (one-sided).||100.78|83.51|
71116635|NCT02516098|141739754|SUPERIORITY_OR_OTHER||Geometric mean ratio (%): T/REF|91.66|||||TWO_SIDED|92.46|83.59|100.51|||||ANOVA model was used with 'sequence', 'treatment' and 'period' as fixed effects and 'subject within sequence' as a random effect after logarithmic transformation of the data.|The test product was compared to the reference product by means of statistical analysis.||100.51|83.59|
71076098|NCT00553358|141660913|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.788||||0.379|TWO_SIDED|95.0|0.46|1.34||The two-sided stratified log-rank test was implemented as the score test from the Cox model.|Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate hazard ratios and corresponding confidence intervals for the pairwise comparisons of individual treatment arms with the trastuzumab alone arm.|||1.34|0.46|0.379
71076099|NCT00553358|141660913|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.962||||0.88|TWO_SIDED|95.0|0.58|1.6||The two-sided stratified log-rank test was implemented as the score test from the Cox model.|Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate hazard ratios and corresponding confidence intervals for the pairwise comparisons of individual treatment arms with the trastuzumab alone arm.|||1.60|0.58|0.880
71076100|NCT00553358|141660914|SUPERIORITY||Hazard Ratio (HR)|0.481||||0.00079|TWO_SIDED|95.0|0.31|0.73|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Overall - All subjects in the EFS landmark analysis||0.73|0.31|0.00079
71076101|NCT00553358|141660914|SUPERIORITY||Hazard Ratio (HR)|0.35||||0.004|TWO_SIDED|95.0|0.16|0.71|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Subjects in the EFS landmark analysis in the lapatinib + trastuzumab arm||0.71|0.16|0.004
71076102|NCT00553358|141660914|SUPERIORITY||Hazard Ratio (HR)|0.532||||0.134|TWO_SIDED|95.0|0.21|1.16|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Subjects in the EFS landmark analysis in the lapatinib arm||1.16|0.21|0.134
71076103|NCT00553358|141660914|SUPERIORITY||Hazard Ratio (HR)|0.601||||0.163|TWO_SIDED|95.0|0.28|1.2|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Subjects in the EFS landmark analysis in the trastuzumab arm||1.20|0.28|0.163
71076104|NCT00553358|141660916|SUPERIORITY||Hazard Ratio (HR)|0.366||||0.00041|TWO_SIDED|95.0|0.2|0.63|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Overall - All subjects in the OS landmark analysis||0.63|0.20|0.00041
71076105|NCT00553358|141660916|SUPERIORITY||Hazard Ratio (HR)|0.223||||0.002|TWO_SIDED|95.0|0.07|0.58|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Subjects in the OS landmark analysis in the lapatinib + trastuzumab arm||0.58|0.07|0.002
71076106|NCT00553358|141660916|SUPERIORITY||Hazard Ratio (HR)|0.433||||0.125|TWO_SIDED|95.0|0.12|1.17|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Subjects in the OS landmark analysis in the lapatinib arm||1.17|0.12|0.125
71076107|NCT00553358|141660916|SUPERIORITY||Hazard Ratio (HR)|0.414||||0.058|TWO_SIDED|95.0|0.15|1.0|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Subjects in the OS landmark analysis in the trastuzumab arm||1.00|0.15|0.058
71076108|NCT03887429|141660926|SUPERIORITY||||||=|0.009|||||||t-test, 1 sided|||It was hypothesized that treatment with SXC-2023 would reduce impulsivity as measured by SSRT in chronic cigarette smokers abstaining from nicotine for 5 days.||||=.009
71076109|NCT03887429|141660927|SUPERIORITY||||||=|0.015|||||||t-test, 1 sided|||It was hypothesized that 5 days of nicotine abstinence in chronic cigarette smokers would result in increased risk taking behavior as measured using DAVT in subjects receiving placebo as treatment.||||=.015
71076110|NCT03887429|141660927|SUPERIORITY||||||>|0.1|||||||t-test, 1 sided|||It was hypothesized that 5 days of nicotine abstinence in chronic cigarette smokers would not result in increased risk taking behavior as measured using DAVT in subjects treated with SXC-2023.||||>.1
70940946|NCT02592434|141381812|SUPERIORITY||Difference in percentage|12.02||||0.0858|TWO_SIDED|95.0|-1.69|25.74|||Normal approximation to the binomial|||Week 44||25.74|-1.69|0.0858
70940947|NCT02592434|141381814|SUPERIORITY||LS mean difference|-2.07|STANDARD_ERROR_OF_MEAN|0.78||0.0088|TWO_SIDED|95.0|-3.6|-0.53|||MMRM|||Week 20; Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.53|-3.60|0.0088
70940948|NCT02592434|141381814|SUPERIORITY||LS mean difference|-3.64|STANDARD_ERROR_OF_MEAN|1.28||0.0054|TWO_SIDED|95.0|-6.17|-1.1|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-1.10|-6.17|0.0054
70940949|NCT02592434|141381814|SUPERIORITY||LS mean difference|-3.85|STANDARD_ERROR_OF_MEAN|1.25||0.0039|TWO_SIDED|95.0|-6.38|-1.32|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-1.32|-6.38|0.0039
71076111|NCT02943785|141660934|NON_INFERIORITY|The two-sided p-value (Noninferiority) was based on the noninferiority margin of 1.38.|Cox Proportional Hazard|1.05||||0.0141|TWO_SIDED|95.0|0.85|1.31|||Regression, Cox|||||1.31|0.85|0.0141
71076112|NCT02943785|141660935|NON_INFERIORITY|The two-sided p-value (Noninferiority) was based on the noninferiority margin of 1.38.|Cox Proportional Hazard|1.4||||0.9267|TWO_SIDED|95.0|1.03|1.91|||Regression, Cox|||||1.91|1.03|0.9267
71076113|NCT01490697|141660974|SUPERIORITY||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-18.0|16.0|||||Placebo plus Placebo - Mifepristone plus d-Cycloserine (DCS)|||16|-18|
71076114|NCT01490697|141660975|SUPERIORITY||Mean Difference (Net)|3.9|||||TWO_SIDED|95.0|-6.9|14.7|||||Placebo plus Placebo - Mifepristone plus d-Cycloserine (DCS)|||14.7|-6.9|
71076115|NCT00090584|141660976|SUPERIORITY_OR_OTHER||Difference in cumulative success rates|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.74|TWO_SIDED|95.0|-0.12|0.12|||Log Rank|||Kaplan Meier Lifetable analysis was used to compute the 8 month cumulative success rates.||0.12|-0.12|0.74
71076116|NCT00090584|141660977|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|2.0||0.34|TWO_SIDED|95.0|-2.0|5.9||Mixed effect repeated measures analysis of variance controlling for study site.|ANOVA|||Test of hypothesis of no difference in change in episodes between the two groups.||5.9|-2.0|0.34
71076117|NCT00090584|141660978|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|0.5||0.08|TWO_SIDED|95.0|-1.7|0.1||Repeated measures ANOVA controlling for clinical site.|ANOVA||Difference (group 1 - group 2) in change from baseline to follow-up in voids per day.|Null hypothesis of no difference between arms in change in number of voids per day from baseline to 10 weeks.||0.1|-1.7|0.08
71076118|NCT00090584|141660979|SUPERIORITY_OR_OTHER||Other|0.0||||0.0006||95.0||||Repeated measures ANOVA|Mixed Models Analysis|Main hypothesis tested by F-test for treatment by time interaction (2 and 509 degrees of freedom). No parameters estimated.||Null hypothesis is that there is no difference between treatment groups in improvement in UDI over time||||0.0006
71076119|NCT00090584|141660980|SUPERIORITY_OR_OTHER||Other|0.0||||0.0005||95.0||||P-value for test of time by treatment group interaction.|Mixed Models Analysis|Adjusted for study site||Repeated measures analysis of difference in symptom bother over time by treatment group.||||0.0005
71076120|NCT00090584|141660981|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.79||||0.02|TWO_SIDED|95.0|1.09|2.92|||Regression, Logistic|Controlling for clinical site and randomization stratum|Ratio of odds of complete satisfaction in Combination therapy arm to Drug only arm.|Null hypothesis: no difference in satisfaction at 10 weeks||2.92|1.09|0.02
71076121|NCT00090584|141660982|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.03||||0.02|TWO_SIDED|95.0|1.11|3.7|||Regression, Logistic|Controlling for clinical site and randomization stratum|Ratio of odds of complete satisfaction in combination therapy group compared to drug only group.|Null hypothesis: No difference in satisfaction at 8 months post intervention||3.70|1.11|0.02
71076122|NCT00090584|141660983|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.55||||0.008|TWO_SIDED|95.0|1.27|5.13||P-value from logistic regression analysis|Regression, Logistic|Controlling for clinical site and randomization stratum||Null hypothesis: No difference in perceived improvement between women in combination therapy group compared to those in drug only group||5.13|1.27|0.008
71076123|NCT00090584|141660984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.17|||<|0.0001|TWO_SIDED|95.0|1.83|5.52|||Regression, Logistic|Controlling for clinical site and randomization stratum||Null hypothesis: No difference in perceived improvement at 8 months between women in combination therapy group compared to those in drug only group.||5.52|1.83|<0.0001
71076124|NCT01969084|141660986|SUPERIORITY_OR_OTHER||||||>|0.05||||||A p-value of \< 0.05 was considered statistically significant|Wilcoxon (Mann-Whitney)|||Data were expressed as the median (25th:75th percentiles) for non-normally distributed data. The mean±sd for the groups was not analyzed as per the statistical plan.||||>0.05
71076125|NCT02436031|141661049|OTHER|||||||0.049|||||||Wilcoxon Matched-Pairs Signed-Rank Test|||Active Pcrit||||0.049
71076126|NCT02436031|141661049|OTHER|||||||0.135|||||||Wilcoxon Matched-Pairs Signed-Rank Test|||Passive Pcrit||||0.135
71076127|NCT03053427|141661112|SUPERIORITY||LSM difference|-1.2|STANDARD_ERROR_OF_MEAN|0.7||0.088|TWO_SIDED|95.0|-2.6|0.2|||Mixed Model of Repeated Measurements|||MMRM with compound symmetry as the covariance structure was used. The explanatory variables of the model included treatment group, IRLS score at baseline, age category, estimated creatinine clearance category, time point, and interaction of treatment group and time point.||0.2|-2.6|0.088
71076128|NCT03053427|141661113|SUPERIORITY||LSM difference|-1.1|STANDARD_ERROR_OF_MEAN|0.6||0.051|TWO_SIDED|95.0|-2.2|0.0|||ANCOVA|Time frame: week 1||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||0.0|-2.2|0.051
71076129|NCT03053427|141661113|SUPERIORITY||LSM difference|-1.5|STANDARD_ERROR_OF_MEAN|0.7||0.02|TWO_SIDED|95.0|-2.8|-0.2|||ANCOVA|Time frame: week 2||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||-0.2|-2.8|0.020
71076130|NCT03053427|141661113|SUPERIORITY||LSM difference|-1.5|STANDARD_ERROR_OF_MEAN|0.7||0.028|TWO_SIDED|95.0|-2.9|-0.2|||ANCOVA|Time frame: week 4||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||-0.2|-2.9|0.028
71076131|NCT03053427|141661113|SUPERIORITY||LSM difference|-1.5|STANDARD_ERROR_OF_MEAN|0.7||0.043|TWO_SIDED|95.0|-2.9|0.0|||ANCOVA|Time frame: week 6||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||-0.0|-2.9|0.043
71076132|NCT03053427|141661113|SUPERIORITY||LSM difference|-1.0|STANDARD_ERROR_OF_MEAN|0.7||0.184|TWO_SIDED|95.0|-2.4|0.5|||ANCOVA|Time frame: week 8||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||0.5|-2.4|0.184
71116636|NCT02516098|141739755|SUPERIORITY_OR_OTHER||Geometric mean ratio (%): T/REF|92.96|||||TWO_SIDED|92.46|81.94|105.47|||||ANOVA model was used with 'sequence', 'treatment' and 'period' as fixed effects and 'subject within sequence' as a random effect after logarithmic transformation of the data.|The test product was compared to the reference product by means of statistical analysis.||105.47|81.94|
71076133|NCT03053427|141661113|SUPERIORITY||LSM difference|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.027|TWO_SIDED|95.0|-3.1|-0.2|||ANCOVA|Time frame: week 10||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||-0.2|-3.1|0.027
71076134|NCT03053427|141661113|SUPERIORITY||LSM difference|-1.4|STANDARD_ERROR_OF_MEAN|0.8||0.087|TWO_SIDED|95.0|-3.0|0.2|||ANCOVA|Time frame: week 12||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||0.2|-3.0|0.087
71076135|NCT03053427|141661113|SUPERIORITY||LSM difference|-0.8|STANDARD_ERROR_OF_MEAN|0.8||0.312|TWO_SIDED|95.0|-2.4|0.8|||ANCOVA|Time frame: EoT||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||0.8|-2.4|0.312
71076136|NCT03053427|141661114|SUPERIORITY||difference|4.2||||0.467|TWO_SIDED|95.0|-6.4|14.8|||Fisher Exact|||||14.8|-6.4|0.467
71076137|NCT03053427|141661115|SUPERIORITY||difference|5.8||||0.3|TWO_SIDED|95.0|-4.8|16.5|||Fisher Exact|||||16.5|-4.8|0.300
71076138|NCT03053427|141661116|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.877|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in PSQI component and global scores from baseline was calculated by visit, using the ANCOVA model with the baseline value as a covariate.||0.5|-0.5|0.877
71076139|NCT03053427|141661117|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.975|TWO_SIDED|95.0|-0.7|0.7|||ANCOVA|||LSM difference (gabapentin enacarbil group minus placebo group) of the changes in total score of Athens insomnia scale from baseline was calculated by visit, using the ANCOVA model with the baseline value as a covariate.||0.7|-0.7|0.975
71076140|NCT03053427|141661118|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.838|TWO_SIDED|95.0|-0.4|0.3|||ANCOVA|||LSM difference (gabapentin enacarbil group minus placebo group) of the changes in RLS pain score from baseline was calculated by visit, using the ANCOVA model with the baseline value as a covariate.||0.3|-0.4|0.838
71116637|NCT01973387|141739756|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.178|||<|0.0001|TWO_SIDED|95.0|0.109|0.291|||Log Rank|||||0.291|0.109|<0.0001
71076141|NCT02172040|141661121|NON_INFERIORITY|Non-inferiority margin definition: lower limit of the 95% confidence interval (CI) for amlodipine + celecoxib arm did not cross the 50% value for the amlodipine arm.|||||=|0.001|||||||t-test, 1 sided|||A serial gatekeeping strategy was used for the primary efficacy endpoint analysis. The primary comparison was a two-sample t-test to test the one-sided hypothesis that treatment with amlodipine + celecoxib was non-inferior to half of the effect achieved with amlodipine.||||= 0.001
71076142|NCT02172040|141661121|SUPERIORITY||||||=|0.491|||||||t-test, 1 sided|||A serial gatekeeping strategy was used for the primary efficacy endpoint analysis. The secondary comparison was a two-sample t-test to test the one-sided hypothesis that treatment with placebo was superior to treatment with celecoxib. This was only to be performed if statistical significance was achieved for the primary comparison.||||= 0.491
71076143|NCT02172040|141661122|OTHER||||||=|0.166|||||||Chi-squared|||||||= 0.166
71076144|NCT02172040|141661123|SUPERIORITY|||||||0.177|||||||t-test, 1 sided|||||||0.177
71076145|NCT02172040|141661123|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71076146|NCT02172040|141661123|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71076147|NCT02172040|141661123|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71076148|NCT02172040|141661123|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71076149|NCT02172040|141661123|SUPERIORITY||||||=|0.719|||||||t-test, 1 sided|||||||= 0.719
71076150|NCT02172040|141661124|SUPERIORITY||||||=|0.069|||||||t-test, 1 sided|||||||= 0.069
71076151|NCT02172040|141661124|SUPERIORITY||||||=|0.001|||||||t-test, 1 sided|||||||= 0.001
71076152|NCT02172040|141661124|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71076153|NCT02172040|141661124|SUPERIORITY||||||=|0.097|||||||t-test, 1 sided|||||||= 0.097
71076154|NCT02172040|141661124|SUPERIORITY||||||=|0.064|||||||t-test, 1 sided|||||||= 0.064
71076155|NCT02172040|141661124|SUPERIORITY||||||=|0.924|||||||t-test, 1 sided|||||||= 0.924
71076156|NCT02172040|141661125|SUPERIORITY||||||=|0.038|||||||t-test, 1 sided|||||||= 0.038
71076157|NCT02172040|141661125|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71076158|NCT02172040|141661125|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71076159|NCT02172040|141661125|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71076160|NCT02172040|141661125|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71076161|NCT02172040|141661125|SUPERIORITY||||||=|0.562|||||||t-test, 1 sided|||||||= 0.562
71076162|NCT02172040|141661126|SUPERIORITY||||||=|0.104|||||||t-test, 1 sided|||||||= 0.104
71076163|NCT02172040|141661126|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71076164|NCT02172040|141661126|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71076165|NCT02172040|141661126|SUPERIORITY||||||=|0.002|||||||t-test, 1 sided|||||||= 0.002
71076166|NCT02172040|141661126|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71076167|NCT02172040|141661126|SUPERIORITY||||||=|0.419|||||||t-test, 1 sided|||||||= 0.419
71076168|NCT02172040|141661127|SUPERIORITY||||||=|0.028|||||||t-test, 1 sided|||||||= 0.028
71076169|NCT02172040|141661127|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71076170|NCT02172040|141661127|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71076171|NCT02172040|141661127|SUPERIORITY||||||=|0.051|||||||t-test, 1 sided|||||||= 0.051
71076172|NCT02172040|141661127|SUPERIORITY||||||=|0.074|||||||t-test, 1 sided|||||||= 0.074
71076173|NCT02172040|141661127|SUPERIORITY||||||=|0.878|||||||t-test, 1 sided|||||||= 0.878
71076174|NCT02172040|141661128|OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71076175|NCT02172040|141661129|OTHER||||||=|0.977|||||||t-test, 1 sided|||||||= 0.977
71076176|NCT02172040|141661130|OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71076177|NCT02172040|141661131|OTHER||||||=|0.527|||||||t-test, 1 sided|||||||= 0.527
71076178|NCT02172040|141661132|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71076179|NCT02172040|141661132|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71076180|NCT02172040|141661132|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71076181|NCT02172040|141661132|SUPERIORITY||||||=|0.001|||||||t-test, 1 sided|||||||= 0.001
71076182|NCT03816644|141661133|SUPERIORITY||Odds Ratio (OR)|3.43|||||TWO_SIDED|95.0|2.32|5.07||||||The estimate of odds ratio, its 95% confidence interval and p-value are obtained from logistic regression models which were used to examine the difference in dementia care outcomes between the intervention and control groups at 90 days post screening visit. Models are adjusted for age, sex, and years of education.||5.07|2.32|
71076183|NCT03816644|141661134|SUPERIORITY||Odds Ratio (OR)|1.133|||||TWO_SIDED|95.0|0.837|1.534||||||The estimate of odds ratio, its 95% confidence interval and p-value are obtained from logistic regression models which were used to examine the difference in participants who were hospitalized or visited an ER 6 months post screening visit.||1.534|0.837|
71076184|NCT02607306|141661138|NON_INFERIORITY|Non-inferiority of IDegLira vs. IDeg was confirmed if the 95% confidence interval for the mean treatment difference lies entirely below 0.3%.|Treatment contrast|-0.63|||<|0.0001|TWO_SIDED|95.0|-0.75|-0.52||p-value for non-inferiority of IDegLira vs IDeg is presented|ANCOVA|||The change from baseline in response after 52 weeks are analysed using an ANCOVA model with treatment and pre-trial OAD as fixed factors and baseline HbA1c value as covariate.||-0.52|-0.75|<0.0001
71076185|NCT02607306|141661138|SUPERIORITY|Superiority of IDegLira vs. Lira was confirmed if the 95% confidence interval for the mean treatment difference for change from baseline in HbA1c lies entirely below 0.0%.|Treatment contrast|-0.48|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.37||p-value for superiority of IDegLira vs Lira is presented|ANCOVA|||The change from baseline in response after 52 weeks are analysed using an ANCOVA model with treatment and pre-trial OAD as fixed factors and baseline HbA1c value as covariate.||-0.37|-0.60|<0.0001
71076186|NCT02607306|141661139|SUPERIORITY|A hierarchical testing procedure is used to control the overall type I error on a two sided 5% level. If and only if non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Lira are confirmed in the primary analysis (change in HbA1c), the three secondary confirmatory tests are performed for superiority of IDegLira versus IDeg with a fixed sequence (1. change in body weight, 2. number of treatment emergent severe or BG confirmed hypoglycaemic episodes and 3. change in HbA1c).|Treatment contrast|-1.19||||0.0001|TWO_SIDED|95.0|-1.8|-0.59||p-value for superiority of IDegLira vs IDeg is presented|ANCOVA|||The change from baseline in response after 52 weeks were analysed using an ANCOVA method with treatment and pre-trial OAD treatment as fixed factors and baseline body weight as covariate.||-0.59|-1.80|0.0001
71076187|NCT02607306|141661140|SUPERIORITY|A hierarchical testing procedure is used to control the overall type I error on a two sided 5% level. If and only if non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Lira are confirmed in the primary analysis (change in HbA1c), the three secondary confirmatory tests are performed for superiority of IDegLira versus IDeg with a fixed sequence (1. change in body weight, 2. number of treatment emergent severe or BG confirmed hypoglycaemic episodes and 3. change in HbA1c).|Treatment contrast|0.48|||<|0.0001|TWO_SIDED|95.0|0.35|0.68||p-value for superiority of IDegLira vs IDeg is presented|Negative binomial regression|||The number of events is analysed using a negative binomial regression model (log link) with the logarithm of the treatment emergent exposure time (100 years) as offset. The model includes treatment and pre-trial OAD treatment as fixed factors.||0.68|0.35|<0.0001
71076188|NCT02607306|141661141|SUPERIORITY|A hierarchical testing procedure is used to control the overall type I error on a two sided 5% level. If and only if non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Lira are confirmed in the primary analysis (change in HbA1c), the three secondary confirmatory tests are performed for superiority of IDegLira versus IDeg with a fixed sequence (1. change in body weight, 2. number of treatment emergent severe or BG confirmed hypoglycaemic episodes and 3. change in HbA1c).|Treatment contrast|-0.63|||<|0.0001|TWO_SIDED|95.0|-0.75|-0.52||p-value for superiority of IDegLira vs IDeg is presented|ANCOVA|||The change from baseline in response after 52 weeks are analysed using an ANCOVA model with treatment, pre-trial OAD as fixed factors and corresponding baseline HbA1c value as covariate.||-0.52|-0.75|<0.0001
71076189|NCT03759366|141661178|SUPERIORITY||Least Square Mean|-5.8||||0.0004|TWO_SIDED|95.0|-8.4|-3.13|||Repeated Measures Model||The least square mean change from baseline in QMG total score at Week 26 was calculated.|The observed change in QMG was analyzed with baseline QMG score and visits as covariates.||-3.13|-8.40|0.0004
71076190|NCT03759366|141661192|SUPERIORITY||Least Square Mean|-4.3||||0.0033|TWO_SIDED|95.0|-6.93|-1.65|||Repeated Measures Model||The least square mean change from baseline in QMG total score at Week 52 was calculated.|The observed change in QMG was analyzed with baseline QMG score and visits as covariates.||-1.65|-6.93|0.0033
71076191|NCT00597012|141661193|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.4||||0.26|TWO_SIDED|95.0|-1.8|6.5|||ANCOVA|||"The primary analysis was implemented with an analysis of covariance with changes in the WOMAC physical-function score from baseline to 6 months as the dependent variable, treatment as the independent variable of interest, and study site as a covariate.~The primary analysis used a modified intention-to-treat approach in which patients who did not withdraw from the study were evaluated in the group to which they were randomly assigned."||6.5|-1.8|0.26
71076192|NCT00597012|141661194|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.9||||0.16|TWO_SIDED|95.0|-1.2|7.0|||ANCOVA|||||7.0|-1.2|0.16
71076193|NCT00597012|141661195|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.1||||0.68|TWO_SIDED|95.0|-4.4|6.6|||ANCOVA|||||6.6|-4.4|0.68
71076194|NCT01093651|141661201|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori threshold for statistical significance was p\<0.05. The main effect analysis for CD4+ T-cell count over time and between the 2 groups did not achieve p\<0.05 (not statistically significant).|Mixed Models Analysis|Study subject was included in these models as a random variable to account for within-participant correlation.||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in CD4+ T-cell count between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.||||>0.05
71076195|NCT01093651|141661202|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori threshold for statistical significance was p\<0.05. The main effect analysis for plasma HIV RNA copy number/mL over time and between the 2 groups did not achieve p\<0.05 (not statistically significant).|Mixed Models Analysis|||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in plasma HIV RNA copy number/mL between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.||||>0.05
71076196|NCT01093651|141661203|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori threshold for statistical significance was p\<0.05. The main effect analysis for serum TNFR2 levels over time and between the 2 groups did not achieve p\<0.05 (not statistically significant).|Mixed Models Analysis|||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in serum TNFR2 levels between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.||||>0.05
71076197|NCT01093651|141661204|SUPERIORITY_OR_OTHER||||||<|0.0002||95.0||||The a priori threshold for statistical significance was p\<0.05. The main effect analysis for SDF1-alpha levels over time and between the 2 groups achieved p\<0.0002.|Mixed Models Analysis|||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in serum SDF1α levels between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.||||<0.0002
71076198|NCT01093651|141661205|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori threshold for statistical significance was p\<0.05. The main effect analysis for serum RANTES levels over time and between the 2 groups did not achieve p\<0.05 (not statistically significant).|Mixed Models Analysis|||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in serum RANTES levels between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.||||>0.05
71076199|NCT01093651|141661206|SUPERIORITY_OR_OTHER||||||<|0.04||95.0||||The a priori threshold for statistical significance was p\<0.05. The main effect analysis for area under the glucose tolerance curve over time and between the 2 groups achieved p\<0.04.|Mixed Models Analysis|||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in area under the glucose tolerance curves between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.||||<0.04
71076200|NCT01093651|141661207|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori threshold for statistical significance was p\<0.05. The non-paramteric test for adverse event cummulative frequency between the 2 groups did not achieve p\<0.05 (not statistically significant)|Kruskal-Wallis|||Kruskal-Wallis non-parametric test of cell frequencies||||>0.05
71076201|NCT03611582|141661209|SUPERIORITY||Treatment difference|-10.27|||<|0.0001|TWO_SIDED|95.0|-11.97|-8.57|||ANCOVA|||Treatment policy estimand||-8.57|-11.97|<.0001
71076202|NCT03611582|141661209|SUPERIORITY||Treatment difference|-12.67|||<|0.0001|TWO_SIDED|95.0|-14.34|-11.0|||MMRM (mixed model repeated measurement)|||Hypothetical estimand||-11.00|-14.34|<0.0001
71076203|NCT03611582|141661210|SUPERIORITY||Odds Ratio (OR)|6.11|||<|0.0001|TWO_SIDED|95.0|4.04|9.26|||Regression, Logistic|||Treatment policy estimand||9.26|4.04|<0.0001
71076204|NCT03611582|141661210|SUPERIORITY||Odds Ratio (OR)|11.67|||<|0.0001|TWO_SIDED|95.0|7.64|17.81|||MMRM (mixed model repeated measurement)|||Hypothetical estimand||17.81|7.64|<0.0001
71076205|NCT04459598|141661240|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|55.24|||||TWO_SIDED|90.0|45.24|67.46|||||For the comparison, the Efavirenz + Quizartinib treatment group represents the numerator and Quizartinib only treatment group represents the denominator.|Statistical comparison was analyzed for Quizartinib.||67.46|45.24|
71076206|NCT04459598|141661240|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|32.37|||||TWO_SIDED|90.0|23.79|44.05|||||For the comparison, the Efavirenz + Quizartinib treatment group represents the numerator and Quizartinib only treatment group represents the denominator.|Statistical comparison was analyzed for AC886.||44.05|23.79|
71076207|NCT04459598|141661242|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|11.11|||||TWO_SIDED|90.0|8.47|14.56|||||For the comparison, the Efavirenz + Quizartinib treatment group represents the numerator and Quizartinib only treatment group represents the denominator.|Statistical comparison was analyzed for Quizartinib.||14.56|8.47|
71076208|NCT04459598|141661242|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|3.67|||||TWO_SIDED|90.0|2.47|5.45|||||For the comparison, the Efavirenz + Quizartinib treatment group represents the numerator and Quizartinib only treatment group represents the denominator.|Statistical comparison was analyzed for AC886.||5.45|2.47|
71076209|NCT04459598|141661243|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|10.29|||||TWO_SIDED|90.0|7.73|13.7|||||For the comparison, the Efavirenz + Quizartinib treatment group represents the numerator and Quizartinib only treatment group represents the denominator.|Statistical comparison was analyzed for Quizartinib.||13.70|7.73|
70940950|NCT02592434|141381814|SUPERIORITY||LS mean difference|-3.3|STANDARD_ERROR_OF_MEAN|0.98||0.0022|TWO_SIDED|95.0|-5.3|-1.29|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-1.29|-5.30|0.0022
71076210|NCT04459598|141661243|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|3.88|||||TWO_SIDED|90.0|2.62|5.76|||||For the comparison, the Efavirenz + Quizartinib treatment group represents the numerator and Quizartinib only treatment group represents the denominator.|Statistical comparison was analyzed for AC886.||5.76|2.62|
71076211|NCT01078298|141661249|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.35|||<|0.0001|TWO_SIDED|95.0|2.16|5.21|||Regression, Logistic|||Odds Ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.||5.21|2.16|<0.0001
71116638|NCT03831191|141739762|SUPERIORITY||Odds Ratio (OR)|0.55||||0.638|TWO_SIDED|95.0|0.04|6.81|||Regression, Logistic|||||6.81|0.04|0.638
71116639|NCT03831191|141739762|SUPERIORITY||Odds Ratio (OR)|0.69||||0.773|TWO_SIDED|95.0|0.05|8.76|||Regression, Logistic|||||8.76|0.05|0.773
71116640|NCT03831191|141739762|SUPERIORITY||Odds Ratio (OR)|0.58||||0.671|TWO_SIDED|95.0|0.05|7.26|||Regression, Logistic|||||7.26|0.05|0.671
71116641|NCT03831191|141739763|SUPERIORITY||Risk Difference (RD)|-4.0|||>|0.999|TWO_SIDED|95.0|-27.2|19.9|||Fisher Exact|||||19.9|-27.2|>0.999
71116642|NCT03831191|141739763|SUPERIORITY||Risk Difference (RD)|4.5|||>|0.999|TWO_SIDED|95.0|-20.7|30.8|||Fisher Exact|||||30.8|-20.7|>0.999
71116643|NCT03831191|141739763|SUPERIORITY||Risk Difference (RD)|-19.0||||0.107|TWO_SIDED|95.0|-40.0|0.2|||Fisher Exact|||||0.2|-40.0|0.107
71116644|NCT03831191|141739764|SUPERIORITY||Risk Difference (RD)|0.2|||>|0.999|TWO_SIDED|95.0|-18.1|19.3|||Fisher Exact|||||19.3|-18.1|>0.999
71116645|NCT03831191|141739764|SUPERIORITY||Risk Difference (RD)|-4.8|||>|0.999|TWO_SIDED|95.0|-22.7|14.1|||Fisher Exact|||||14.1|-22.7|>0.999
71116646|NCT03831191|141739764|SUPERIORITY||Risk Difference (RD)|-4.8|||>|0.999|TWO_SIDED|95.0|-22.7|11.2|||Fisher Exact|||||11.2|-22.7|>0.999
71116647|NCT03831191|141739765|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.0|0.0|
71116648|NCT03831191|141739765|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.0|0.0|
71116649|NCT03831191|141739765|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.0|0.0|
70940951|NCT02592434|141381814|SUPERIORITY||LS mean difference|-6.21|STANDARD_ERROR_OF_MEAN|1.57||0.0005|TWO_SIDED|95.0|-9.42|-3.0|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-3.00|-9.42|0.0005
70940952|NCT02592434|141381814|SUPERIORITY||LS mean difference|-6.26|STANDARD_ERROR_OF_MEAN|1.63||0.0006|TWO_SIDED|95.0|-9.6|-2.92|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-2.92|-9.60|0.0006
70940953|NCT02592434|141381814|SUPERIORITY||LS mean difference|-4.36|STANDARD_ERROR_OF_MEAN|1.27||0.0027|TWO_SIDED|95.0|-7.02|-1.71|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-1.71|-7.02|0.0027
70940954|NCT02592434|141381816|SUPERIORITY||LS Mean Difference|-1.83|STANDARD_ERROR_OF_MEAN|0.76||0.0172|TWO_SIDED|95.0|-3.32|-0.33|||MMRM|||Week 20: Analysis was based on Mixed Model for Repeated Measures (MMRM) with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-0.33|-3.32|0.0172
71076212|NCT01078298|141661250|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.53||||0.0001|TWO_SIDED|95.0|1.56|4.1|||Regression, Logistic|||For Week 9 through 24, odds ratio and p-value were calculated from logistic regression model including the main effects of treatment, pooled center and cohort.||4.10|1.56|0.0001
71076213|NCT01078298|141661250|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.36||||0.0011|TWO_SIDED|95.0|1.4|3.98|||Regression, Logistic|||For Week 9 through 52, odds ratio and p-value were calculated from logistic regression model including the main effects of treatment, pooled center and cohort.||3.98|1.40|0.0011
71116650|NCT03831191|141739766|SUPERIORITY||Median Difference (Net)|6.55||||0.31|TWO_SIDED|95.0|-6.36|19.45|||Mixed Models Analysis|||||19.45|-6.36|0.310
71116651|NCT03831191|141739766|SUPERIORITY||Mean Difference (Net)|5.56||||0.393|TWO_SIDED|95.0|-7.5|18.63|||Mixed Models Analysis|||||18.63|-7.50|0.393
71116652|NCT03831191|141739766|SUPERIORITY||Mean Difference (Net)|3.59||||0.564|TWO_SIDED|95.0|-8.91|16.08|||Mixed Models Analysis|||||16.08|-8.91|0.564
71116653|NCT03831191|141739767|SUPERIORITY||Mean Difference (Net)|7.61||||0.356|TWO_SIDED|95.0|-8.82|24.05|||Mixed Models Analysis|||||24.05|-8.82|0.356
71116654|NCT03831191|141739767|SUPERIORITY||Mean Difference (Net)|2.33||||0.783|TWO_SIDED|95.0|-14.64|19.3|||Mixed Models Analysis|||||19.30|-14.64|0.783
70940955|NCT02592434|141381816|SUPERIORITY||LS Mean Difference|-3.41|STANDARD_ERROR_OF_MEAN|1.21||0.0057|TWO_SIDED|95.0|-5.81|-1.01|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-1.01|-5.81|0.0057
71076214|NCT01078298|141661251|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.82|||<|0.0001|TWO_SIDED|95.0|2.53|5.78|||Regression, Logistic|||For Week 12, odds ratio and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.||5.78|2.53|<0.0001
70940956|NCT02592434|141381816|SUPERIORITY||LS Mean Difference|-3.58|STANDARD_ERROR_OF_MEAN|1.16||0.0038|TWO_SIDED|95.0|-5.94|-1.23|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-1.23|-5.94|0.0038
70940957|NCT02592434|141381816|SUPERIORITY||LS Mean Difference|-3.41|STANDARD_ERROR_OF_MEAN|1.01||0.002|TWO_SIDED|95.0|-5.47|-1.36|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-1.36|-5.47|0.0020
70940958|NCT02592434|141381816|SUPERIORITY||LS Mean Difference|-5.66|STANDARD_ERROR_OF_MEAN|1.52||0.0007|TWO_SIDED|95.0|-8.74|-2.57|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-2.57|-8.74|0.0007
70940959|NCT02592434|141381816|SUPERIORITY||LS Mean Difference|-5.62|STANDARD_ERROR_OF_MEAN|1.49||0.0007|TWO_SIDED|95.0|-8.66|-2.58|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-2.58|-8.66|0.0007
70940960|NCT02592434|141381816|SUPERIORITY||LS Mean Difference|-4.41|STANDARD_ERROR_OF_MEAN|1.25||0.0018|TWO_SIDED|95.0|-6.99|-1.82|||MMRM|||Week 44:Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-1.82|-6.99|0.0018
70940961|NCT02592434|141381818|SUPERIORITY||Difference in percentage|1.47||||0.861|TWO_SIDED|95.0|-14.96|17.9|||Normal approximation to the binomial|||Double Blind Baseline (Week 18)||17.90|-14.96|0.8610
70940962|NCT02592434|141381818|SUPERIORITY||Difference in percentage|10.12||||0.2173|TWO_SIDED|95.0|-5.96|26.2|||Normal approximation to the binomial|||Week 20||26.20|-5.96|0.2173
70940963|NCT02592434|141381818|SUPERIORITY||Difference in percentage|12.94||||0.1135|TWO_SIDED|95.0|-3.08|28.96|||Normal approximation to the binomial|||Week 24||28.96|-3.08|0.1135
71076215|NCT01078298|141661251|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.16||||0.0004|TWO_SIDED|95.0|1.4|3.33|||Regression, Logistic|||For Week 24, odds ratio and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.||3.33|1.40|0.0004
71116655|NCT03831191|141739767|SUPERIORITY||Mean Difference (Net)|6.52||||0.414|TWO_SIDED|95.0|-9.4|22.43|||Mixed Models Analysis|||||22.43|-9.40|0.414
71116656|NCT01562314|141739770|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.821||||0.7532|TWO_SIDED|90.0|0.292|2.309|||Regression, Logistic|||||2.309|0.292|0.7532
71116657|NCT01562314|141739771|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.7032|TWO_SIDED|90.0|0.419|4.04|||Regression, Logistic|||||4.040|0.419|0.7032
71116658|NCT02512874|141739795|SUPERIORITY|||||||0.62|||||||Chi-squared|||||||0.62
71117728|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-51.54|||<|0.001|TWO_SIDED|95.0|-68.42|-34.66||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-34.66|-68.42|<0.001
71076216|NCT01078298|141661251|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.98||||0.002|TWO_SIDED|95.0|1.28|3.08|||Regression, Logistic|||For Week 52, odds ratio and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.||3.08|1.28|0.0020
71116659|NCT02357472|141739813|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sample Size to Achieve 0.80 Power to Test Equivalency at the α = 0.05 Significance Level for True Proportions|Mean Difference (Final Values)|1.31|STANDARD_ERROR_OF_MEAN|1.31||0.0003|TWO_SIDED|95.0|0.6216|2.002|||t-test, 2 sided|||It was caculated that 60 paticipants randomized in a 1:1between 2 arms would would have at least 85% power to detect a difference of 1.32 oocytes between the high dose group and standard dose group after 12 weeks.Sample size was determined using 2 sided 2 sample t-test (α = 0.05).Assumptions included a common standard deviation of 1.72.||2.002|0.6216|0.0003
71076217|NCT01078298|141661252|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.97||||0.0027|TWO_SIDED|95.0|1.26|3.08|||Regression, Logistic|||Odds Ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.||3.08|1.26|0.0027
71076218|NCT01653327|141661266|SUPERIORITY|||||||0.3198|||||||t-test, 2 sided|||||||0.3198
71076219|NCT01653327|141661267|SUPERIORITY|||||||0.3522|||||||t-test, 2 sided|||||||0.3522
71076220|NCT01738191|141661268|SUPERIORITY|||||||0.25||||||two sided|Global Statistical Test|df=28||The primary comparison between ATM and placebo used O'Brien's Global Statistical Test (GST) to analyze change from baseline to 10 weeks for the set of neuropsychological measures included in the primary efficacy outcome.||||0.25
71076221|NCT02243046|141661276|SUPERIORITY_OR_OTHER|||||||0.091|||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.091
71076222|NCT02243046|141661277|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
71076223|NCT02243046|141661278|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups||||< 0.001
71076224|NCT02243046|141661279|SUPERIORITY_OR_OTHER|||||||0.571|||||||ANOVA|||The null hypothesis states that there is no difference between groups||||0.571
71076225|NCT02243046|141661280|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||The null hypothesis states that there is no difference between groups||||< 0.001
71076226|NCT02243046|141661281|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||The null hypothesis states that there is no difference between groups||||< 0.001
71076227|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.527||||0.0211|TWO_SIDED|95.0|0.306|0.908|||Regression, Logistic|||The statistical analysis is presented for Gamma-Glutamyl Transferase (Gamma-GT) in log10 international units per liter (IU/L) at BL. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week \[Wk\]12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.908|0.306|0.0211
71076228|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.078|||<|0.0001|TWO_SIDED|95.0|1.065|1.092|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.092|1.065|<0.0001
71076229|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.0053|TWO_SIDED|95.0|1.061|1.403|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, during the first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.403|1.061|0.0053
71076230|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.464||||0.0079|TWO_SIDED|95.0|0.264|0.818|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.818|0.264|0.0079
70940964|NCT02592434|141381818|SUPERIORITY||Difference in percentage|11.51||||0.161|TWO_SIDED|95.0|-4.58|27.6|||Normal approximation to the binomial|||Week 28||27.60|-4.58|0.1610
71076231|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.737||||0.1808|TWO_SIDED|95.0|0.471|1.153|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.153|0.471|0.1808
71076232|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.082|||<|0.0001|TWO_SIDED|95.0|1.069|1.095|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.095|1.069|<0.0001
71076233|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.676||||0.0005|TWO_SIDED|95.0|0.542|0.844|||Regression, Logistic|||The statistical analysis is presented for Weight per 10 kilogram (kg). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.844|0.542|0.0005
71076234|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.573||||0.0041|TWO_SIDED|95.0|0.392|0.838|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.838|0.392|0.0041
70853685|NCT00759564|141195497|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|110.12|||||TWO_SIDED|90.0|89.84|134.98||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||134.98|89.84|
71076235|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.094|||<|0.0001|TWO_SIDED|95.0|1.048|1.142|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.142|1.048|<0.0001
71076236|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.945||||0.0031|TWO_SIDED|95.0|2.013|31.359|||Regression, Logistic|||The statistical analysis is presented for cumulative PEG-IFN alfa-2a dose per 1000 ug, first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||31.359|2.013|0.0031
71076237|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.0012|TWO_SIDED|95.0|0.844|0.959|||Regression, Logistic|||The statistical analysis is presented for body mass index (BMI) in kilogram per square meter (kg/m\^2). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.959|0.844|0.0012
71076238|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.619||||0.0085|TWO_SIDED|95.0|0.433|0.885|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.885|0.433|0.0085
71076239|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13|||<|0.0001|TWO_SIDED|95.0|1.087|1.174|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.174|1.087|<0.0001
71076240|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.784||||0.0341|TWO_SIDED|95.0|0.626|0.982|||Regression, Logistic|||The statistical analysis is presented for Weight per 10 kg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.982|0.626|0.0341
71076241|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.575||||0.0443|TWO_SIDED|95.0|0.335|0.986|||Regression, Logistic|||The statistical analysis is presented for aspartate aminotransferase (AST) ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.986|0.335|0.0443
71076242|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1|||<|0.0001|TWO_SIDED|95.0|1.057|1.144|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.144|1.057|<0.0001
71076243|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|22.867||||0.0039|TWO_SIDED|95.0|2.73|191.56|||Regression, Logistic|||The statistical analysis is presented for cumulative PEG-IFN alfa-2a dose per 1000 ug, during the first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||191.56|2.730|0.0039
71076244|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.0244|TWO_SIDED|95.0|0.628|0.968|||Regression, Logistic|||The statistical analysis is presented for Weight per 10 kg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a||0.968|0.628|0.0244
71076245|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.128|||<|0.0001|TWO_SIDED|95.0|1.086|1.172|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.172|1.086|<0.0001
71076246|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.547||||0.0453|TWO_SIDED|95.0|0.303|0.987|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||0.987|0.303|0.0453
70940965|NCT02592434|141381818|SUPERIORITY||Difference in percentage|7.42||||0.3571|TWO_SIDED|95.0|-8.37|23.21|||Normal approximation to the binomial|||Week 32||23.21|-8.37|0.3571
71076247|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.133||||0.0184|TWO_SIDED|95.0|0.025|0.712|||Regression, Logistic|||The statistical analysis is presented for Gamma-GT in log10 (IU/L) at BL. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||0.712|0.025|0.0184
71076248|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.103|||<|0.0001|TWO_SIDED|95.0|1.072|1.134|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in Weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||1.134|1.072|<0.0001
70940966|NCT02592434|141381818|SUPERIORITY||Difference in percentage|14.44||||0.0716|TWO_SIDED|95.0|-1.27|30.16|||Normal approximation to the binomial|||Week 36||30.16|-1.27|0.0716
70940967|NCT02592434|141381818|SUPERIORITY||Difference in percentage|14.4||||0.0746|TWO_SIDED|95.0|-1.43|30.24|||Normal approximation to the binomial|||Week 40||30.24|-1.43|0.0746
71116660|NCT00349921|141739828|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||Null hypothesis is that there is no difference between the groups in proportion of patients meeting the success criterion of \>30% reduction in visual analog scale pain 120 min after intrathecal injection||||>0.05
71116661|NCT00778258|141739837|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.77||||0.58|TWO_SIDED|95.0|0.31|1.93|||Regression, Logistic|||||1.93|0.31|0.58
71116662|NCT00778258|141739838|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.13||||0.78|TWO_SIDED|95.0|0.48|2.68|||Chi-squared|||Progression comparison at 12 Months||2.68|0.48|0.78
71116663|NCT00778258|141739838|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.81||||0.62|TWO_SIDED|95.0|0.34|1.91|||Chi-squared|||Progression comparison at 24 Months||1.91|0.34|0.62
71116664|NCT00778258|141739839|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||Chi-squared|||Comparison at 12 Months||||0.14
71116665|NCT00778258|141739839|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||Chi-squared|||Comparison at 24 Months||||0.17
71116666|NCT00778258|141739839|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED||||||Chi-squared|||Comparison at 36 Months||||0.33
71116667|NCT00778258|141739840|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Chi-squared|||||||0.41
71116668|NCT00778258|141739841|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Kruskal-Wallis|||||||0.09
71116669|NCT00778258|141739841|SUPERIORITY_OR_OTHER|||||||0.01||||||Null hypothesis is that correlation = 0|Spearman's Correlation|||||||0.01
71116670|NCT00778258|141739842|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Kruskal-Wallis|||Analysis on Betalactoglobulin||||<0.01
71116671|NCT00778258|141739842|SUPERIORITY_OR_OTHER||||||<|0.01||||||Null hypothesis is that correlation = 0|Spearman Correlation|||Analysis on Betalactoglobulin IgE||||<0.01
71116672|NCT00778258|141739842|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Kruskal-Wallis|||Analysis on Casein IgE||||<0.01
71116673|NCT00778258|141739842|SUPERIORITY_OR_OTHER||||||<|0.01||||||Null hypothesis is that correlation = 0|Spearman Correlation|||Analysis on Casein IgE||||<0.01
71116674|NCT00778258|141739842|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Kruskal-Wallis|||Analysis on Cow's Milk IgE||||<0.01
71116675|NCT00778258|141739842|SUPERIORITY_OR_OTHER||||||<|0.01||||||Null hypothesis is that correlation = 0|Spearman Correlation|||Analysis on Cow's Milk IgE||||<0.01
71116676|NCT00778258|141739843|SUPERIORITY_OR_OTHER|||||||0.01|||||||Kruskal-Wallis|||Analysis on Max Basophil Assessment||||0.01
71116677|NCT00778258|141739843|SUPERIORITY_OR_OTHER|||||||0.22||||||Null hypothesis is that correlation = 0|Spearman Correlation|||Analysis on Max Basophil Assessment||||0.22
71116678|NCT00778258|141739843|SUPERIORITY_OR_OTHER|||||||0.59|||||||Kruskal-Wallis|||Analysis on Tregs||||0.59
71116679|NCT00778258|141739843|SUPERIORITY_OR_OTHER|||||||0.32||||||Null hypothesis is that correlation = 0|Spearman Correlation|||Analysis on Tregs||||0.32
71116680|NCT00778258|141739844|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Kruskal-Wallis|||||||0.50
71116681|NCT00778258|141739845|SUPERIORITY_OR_OTHER|||||||0.033||||||Correlation = -0.18|Spearman Correlation|||Baseline Comparison||||0.033
71116682|NCT00778258|141739845|SUPERIORITY_OR_OTHER|||||||0.002||||||Correlation = -0.34|Spearman Correlation|||Month 12 Comparison||||0.002
71116683|NCT00778258|141739845|SUPERIORITY_OR_OTHER|||||||0.156||||||Correlation = -0.20|Spearman Correlation|||Month 24 Comparison||||0.156
71116684|NCT00778258|141739845|SUPERIORITY_OR_OTHER|||||||0.077||||||Correlation = -0.27|Spearman Correlation|||Month 36 Comparison||||0.077
71116685|NCT00778258|141739846|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared|||36 Month Comparison||||<0.01
71116686|NCT01926041|141739853|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.008|TWO_SIDED|95.0|0.48|0.84||Statistical significance levels were determined by two-tailed tests (P \< 0.05).|Regression, Cox|||||0.84|0.48|0.008
71116687|NCT01926041|141739854|SUPERIORITY||Cox Proportional Hazard|1.85||||0.023|TWO_SIDED|95.0|1.13|3.04||Statistical significance levels were determined by two-tailed tests (P \< 0.05).|Regression, Cox|||||3.04|1.13|0.023
71116688|NCT01926041|141739860|OTHER||Beta Coefficient|-0.1|STANDARD_ERROR_OF_MEAN|0.16|<|0.05|TWO_SIDED||||||Regression, Linear|||||||<0.05
71116689|NCT03111550|141739865|SUPERIORITY|Compare if study AE rate is significantly higher than ISO SPE rate (0.3% for corneal edema)||||||0.02041|ONE_SIDED||||||Exact test on binomial distribution|||||||0.02041
71116690|NCT03111550|141739866|SUPERIORITY|Compare if study AE rate is significantly higher than ISO SPE rate (0.3% for retinal detachment)||||||0.1969|ONE_SIDED|||||For ZQR00 retinal detachment|Exact test on binomial distribution|||||||0.1969
71116691|NCT03111550|141739866|SUPERIORITY|Compare if study AE rate is significantly higher than ISO SPE rate (0.8% for secondary surgical intervention)||||||0.4655|ONE_SIDED|||||For ZHR00 secondary surgical intervention|Exact test of binomial distribution|||||||0.4655
71116692|NCT03111550|141739866|SUPERIORITY|Compare if study AE rate is significantly higher than ISO SPE rate (0.8% for secondary surgical intervention)||||||0.021|ONE_SIDED|||||For ZQR00 secondary surgical intention|Exact test on binomial distribution|||||||0.0210
70853686|NCT00759564|141195499|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|134.86|||||TWO_SIDED|90.0|109.88|165.52||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||165.52|109.88|
71076249|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.543||||0.0019|TWO_SIDED|95.0|0.37|0.798|||Regression, Logistic|||The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||0.798|0.370|0.0019
71076250|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.359||||0.0017|TWO_SIDED|95.0|0.189|0.679|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||0.679|0.189|0.0017
71076251|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08|||<|0.0001|TWO_SIDED|95.0|1.047|1.114|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||1.114|1.047|<0.0001
71076252|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.093||||0.0042|TWO_SIDED|95.0|1.029|1.162|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||1.162|1.029|0.0042
71076253|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.535||||0.0168|TWO_SIDED|95.0|0.32|0.893|||Regression, Logistic|||The statistical analysis is presented for Gamma-GT in log10 (IU/L) at BL. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.893|0.320|0.0168
71076254|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.501||||0.0128|TWO_SIDED|95.0|0.291|0.864|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.864|0.291|0.0128
71076255|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.853||||0.4634|TWO_SIDED|95.0|0.558|1.305|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.305|0.558|0.4634
71116693|NCT03111550|141739866|SUPERIORITY|Compare if study AE rate is significantly higher than ISO SPE rate (0.8% for secondary surgical intervention)||||||0.4698|ONE_SIDED|||||For ZXR00 secondary surgical intervention|Exact test on binomial distribution|||||||0.4698
71116694|NCT00218634|141739918|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||HLM|||We used HLM with weekly visit data for the acute outcome. There were, therefore, 11 time points used.||||<.05
71116695|NCT00218634|141739919|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||GLM - CBT-AD would be superior to ETAU at post. HLM - CBT-AD would be superior to CBT-AD at follow ups.|GLM and HLM|||||||<.05
71116696|NCT00218634|141739921|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||CD4 would be more improved in the treatment condition|HLM|||follow up analysis revealed that CD4, over time, significantly improved over control when covarying out baseline levels.||||<.05
71116697|NCT05243745|141739941|SUPERIORITY||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.136||0.499|TWO_SIDED|95.0|-0.36|0.18|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 3||0.18|-0.36|0.4990
71116698|NCT05243745|141739941|SUPERIORITY||Adjusted Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.135|<|0.0001|TWO_SIDED|95.0|-0.83|-0.29|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 3||-0.29|-0.83|<0.0001
70853687|NCT00759564|141195499|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|226.28|||||TWO_SIDED|90.0|184.36|277.72||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||277.72|184.36|
70940968|NCT02592434|141381818|SUPERIORITY||Difference in percentage|14.37||||0.0773|TWO_SIDED|95.0|-1.57|30.3|||Normal approximation to the binomial|||Week 44||30.30|-1.57|0.0773
71076256|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|19.655|||<|0.0001|TWO_SIDED|95.0|9.725|39.722|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (Rapid Virological Response \[RVR\] vs No RVR/EVR \[Early Virological Response\]). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||39.722|9.725|<0.0001
71116699|NCT05243745|141739941|SUPERIORITY||Adjusted Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.137|<|0.0001|TWO_SIDED|95.0|-1.1|-0.56|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference is calculated as Test value minus Negative Control value.|Change from Baseline at Day 3||-0.56|-1.10|<0.0001
71116700|NCT05243745|141739941|SUPERIORITY||Adjusted Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.112||0.009|TWO_SIDED|95.0|-0.52|-0.08|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 14||-0.08|-0.52|0.0090
70940969|NCT02592434|141381820|SUPERIORITY||Difference in percentage|-3.06||||0.5131|TWO_SIDED|95.0|-12.21|6.1|||Normal approximation to the binomial|||Double Blind Baseline (Week 18)||6.10|-12.21|0.5131
70940970|NCT02592434|141381820|SUPERIORITY||Difference in percentage|6.87||||0.0876|TWO_SIDED|95.0|-1.01|14.74|||Normal approximation to the binomial|||Week 20||14.74|-1.01|0.0876
71076257|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.569|||<|0.0001|TWO_SIDED|95.0|4.408|16.658|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR \[Complete Early Virological Response\] vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||16.658|4.408|<0.0001
70940971|NCT02592434|141381820|SUPERIORITY||Difference in percentage|6.79||||0.1561|TWO_SIDED|95.0|-2.59|16.16|||Normal approximation to the binomial|||Week 24||16.16|-2.59|0.1561
70940972|NCT02592434|141381820|SUPERIORITY||Difference in percentage|2.58||||0.5795|TWO_SIDED|95.0|-6.54|11.7|||Normal approximation to the binomial|||Week 28||11.70|-6.54|0.5795
71076258|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.519||||0.0089|TWO_SIDED|95.0|1.26|5.034|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR \[Partial Early Virological Response\] vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||5.034|1.260|0.0089
71076259|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.908||||0.0037|TWO_SIDED|95.0|0.851|0.969|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.969|0.851|0.0037
71076260|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.553||||0.002|TWO_SIDED|95.0|0.379|0.805|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.805|0.379|0.0020
71076261|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.537||||0.0003|TWO_SIDED|95.0|3.654|74.849|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a||74.849|3.654|0.0003
71076262|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.386||||0.0733|TWO_SIDED|95.0|0.87|22.114|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||22.114|0.870|0.0733
71076263|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.352||||0.3478|TWO_SIDED|95.0|0.394|14.031|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||14.031|0.394|0.3478
71076264|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.729||||0.0264|TWO_SIDED|95.0|0.552|0.964|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.964|0.552|0.0264
71076265|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.658||||0.0096|TWO_SIDED|95.0|1.586|27.946|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||27.946|1.586|0.0096
71076266|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.734||||0.0421|TWO_SIDED|95.0|1.057|21.203|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||21.203|1.057|0.0421
71116701|NCT05243745|141739941|SUPERIORITY||Adjusted Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.111|<|0.0001|TWO_SIDED|95.0|-0.89|-0.45|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 14||-0.45|-0.89|<0.0001
70940973|NCT02592434|141381820|SUPERIORITY||Difference in percentage|5.4||||0.2435|TWO_SIDED|95.0|-3.67|14.47|||Normal approximation to the binomial|||Week 32||14.47|-3.67|0.2435
70940974|NCT02592434|141381820|SUPERIORITY||Difference in percentage|9.52||||0.0758|TWO_SIDED|95.0|-0.99|20.04|||Normal approximation to the binomial|||Week 36||20.04|-0.99|0.0758
70940975|NCT02592434|141381820|SUPERIORITY||Difference in percentage|10.91||||0.0464|TWO_SIDED|95.0|0.17|21.65|||Normal approximation to the binomial|||Week 40||21.65|0.17|0.0464
70940976|NCT02592434|141381820|SUPERIORITY||Difference in percentage|8.06||||0.1634|TWO_SIDED|95.0|-3.27|19.38|||Normal approximation to the binomial|||Week 44||19.38|-3.27|0.1634
70940977|NCT02592434|141381821|SUPERIORITY||Difference in percentage|-17.42||||0.0062|TWO_SIDED|95.0|-29.88|-4.96|||Normal approximation to the binomial|||Double Blind baseline (Week 18)||-4.96|-29.88|0.0062
70940978|NCT02592434|141381821|SUPERIORITY||Difference in percentage|-0.44||||0.9427|TWO_SIDED|95.0|-12.34|11.47|||Normal approximation to the binomial|||Week 20||11.47|-12.34|0.9427
70940979|NCT02592434|141381821|SUPERIORITY||Difference in percentage|-0.6||||0.9308|TWO_SIDED|95.0|-14.03|12.84|||Normal approximation to the binomial|||Week 24||12.84|-14.03|0.9308
70940980|NCT02592434|141381821|SUPERIORITY||Difference in percentage|0.87||||0.8945|TWO_SIDED|95.0|-12.03|13.78|||Normal approximation to the binomial|||Week 28||13.78|-12.03|0.8945
70940981|NCT02592434|141381821|SUPERIORITY||Difference in percentage|2.22||||0.7455|TWO_SIDED|95.0|-11.2|15.64|||Normal approximation to the binomial|||Week 32||15.64|-11.20|0.7455
71076267|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.602||||0.6004|TWO_SIDED|95.0|0.09|4.014|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||4.014|0.090|0.6004
71076268|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.715||||0.0418|TWO_SIDED|95.0|0.517|0.988|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||0.988|0.517|0.0418
71076269|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.198||||0.0279|TWO_SIDED|95.0|0.047|0.839|||Regression, Logistic|||The statistical analysis is presented for Gamma-GT in log10 (IU/L) at BL. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||0.839|0.047|0.0279
71116702|NCT05243745|141739941|SUPERIORITY||Adjusted Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|0.112|<|0.0001|TWO_SIDED|95.0|-1.66|-1.22|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control value.|Change from Baseline at Day 14||-1.22|-1.66|<0.0001
71116703|NCT05243745|141739941|SUPERIORITY||Adjusted Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.116||0.0007|TWO_SIDED|95.0|-0.63|-0.17|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 28||-0.17|-0.63|0.0007
70940982|NCT02592434|141381821|SUPERIORITY||Difference in percentage|9.25||||0.1787|TWO_SIDED|95.0|-4.23|22.72|||Normal approximation to the binomial|||Week 36||22.72|-4.23|0.1787
71076270|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|40.88|||<|0.0001|TWO_SIDED|95.0|7.474|223.61|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||223.61|7.474|<0.0001
71076271|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|42.395|||<|0.0001|TWO_SIDED|95.0|8.724|206.02|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||206.02|8.724|<0.0001
71076272|NCT01066793|141661343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.247||||0.0087|TWO_SIDED|95.0|1.704|39.908|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||39.908|1.704|0.0087
71076273|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.957||||0.0002|TWO_SIDED|95.0|1.383|2.77|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.770|1.383|0.0002
71076274|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.337||||0.0007|TWO_SIDED|95.0|1.661|6.705|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.705|1.661|0.0007
71076275|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.305||||0.3611|TWO_SIDED|95.0|0.737|2.312|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.312|0.737|0.3611
71076276|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.943|||<|0.0001|TWO_SIDED|95.0|0.929|0.958|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.958|0.929|<0.0001
71076277|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.743||||0.002|TWO_SIDED|95.0|0.615|0.897|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, during the first 12 weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.897|0.615|0.0020
71116704|NCT05243745|141739941|SUPERIORITY||Adjusted Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.116|<|0.0001|TWO_SIDED|95.0|-0.85|-0.39|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 28||-0.39|-0.85|<0.0001
70940983|NCT02592434|141381821|SUPERIORITY||Difference in percentage|12.1||||0.0695|TWO_SIDED|95.0|-0.97|25.17|||Normal approximation to the binomial|||Week 40||25.17|-0.97|0.0695
70940984|NCT02592434|141381821|SUPERIORITY||Difference in percentage|9.25||||0.1787|TWO_SIDED|95.0|-4.23|22.72|||Normal approximation to the binomial|||Week 44||22.72|-4.23|0.1787
70940985|NCT02592434|141381822|SUPERIORITY||Difference in percentage|-0.12||||0.9719|TWO_SIDED|95.0|-6.74|6.5|||Normal approximation to the binomial|||||6.50|-6.74|0.9719
71076278|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.864||||0.0004|TWO_SIDED|95.0|1.322|2.628|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.628|1.322|0.0004
71076279|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.124||||0.0386|TWO_SIDED|95.0|1.04|4.338|||Regression, Logistic|||The statistical analysis is presented for mode of infection (other vs injection drug U). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||4.338|1.040|0.0386
71076280|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.398||||0.0004|TWO_SIDED|95.0|1.722|6.706|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.706|1.722|0.0004
71076281|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.372||||0.2769|TWO_SIDED|95.0|0.776|2.428|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.428|0.776|0.2769
71076282|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.945|||<|0.0001|TWO_SIDED|95.0|0.931|0.96|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.960|0.931|<0.0001
71076283|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.163||||0.0001|TWO_SIDED|95.0|1.078|1.256|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.256|1.078|0.0001
71076284|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.788||||0.0213|TWO_SIDED|95.0|1.091|2.932|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.932|1.091|0.0213
71076285|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.903||||0.0002|TWO_SIDED|95.0|0.856|0.953|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.953|0.856|0.0002
71076286|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.723||||0.0306|TWO_SIDED|95.0|0.538|0.97|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, first 12 weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.970|0.538|0.0306
71076287|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.145||||0.0005|TWO_SIDED|95.0|1.061|1.236|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.236|1.061|0.0005
71076288|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.907||||0.0122|TWO_SIDED|95.0|1.151|3.158|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.158|1.151|0.0122
71076289|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.175||||0.0956|TWO_SIDED|95.0|0.872|5.424|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||5.424|0.872|0.0956
71116705|NCT05243745|141739941|SUPERIORITY||Adjusted Mean Difference|-1.62|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.85|-1.38|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control value.|Change from Baseline at Day 28||-1.38|-1.85|<0.0001
71116706|NCT05243745|141739941|SUPERIORITY||Adjusted Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.112||0.0015|TWO_SIDED|95.0|-0.59|-0.14|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 56||-0.14|-0.59|0.0015
71076290|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.267||||0.0846|TWO_SIDED|95.0|0.06|1.197|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.197|0.060|0.0846
71116707|NCT05243745|141739941|SUPERIORITY||Adjusted Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.113|<|0.0001|TWO_SIDED|95.0|-1.05|-0.61|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 56||-0.61|-1.05|<0.0001
71116708|NCT05243745|141739941|SUPERIORITY||Adjusted Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|0.115|<|0.0001|TWO_SIDED|95.0|-1.95|-1.49|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control.|Change from Baseline at Day 56||-1.49|-1.95|<0.0001
71116709|NCT05243745|141739942|SUPERIORITY||Adjusted Mean Difference|5.93|STANDARD_ERROR_OF_MEAN|2.572||0.0231|TWO_SIDED|95.0|0.83|11.02|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 3||11.02|0.83|0.0231
71116710|NCT05243745|141739942|SUPERIORITY||Adjusted Mean Difference|18.42|STANDARD_ERROR_OF_MEAN|2.549|<|0.0001|TWO_SIDED|95.0|13.37|23.47|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 3||23.47|13.37|<0.0001
71116711|NCT05243745|141739942|SUPERIORITY||Adjusted Mean Difference|23.93|STANDARD_ERROR_OF_MEAN|2.571|<|0.0001|TWO_SIDED|95.0|18.83|29.02|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control.|Change from Baseline at Day 3||29.02|18.83|<0.0001
71116712|NCT05243745|141739942|SUPERIORITY||Adjusted Mean Difference|8.97|STANDARD_ERROR_OF_MEAN|2.293||0.0002|TWO_SIDED|95.0|4.43|13.51|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 14||13.51|4.43|0.0002
71116713|NCT05243745|141739942|SUPERIORITY||Slope|17.71|STANDARD_ERROR_OF_MEAN|2.265|<|0.0001|TWO_SIDED|95.0|13.22|22.2|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 14||22.20|13.22|<0.0001
71116714|NCT05243745|141739942|SUPERIORITY||Adjusted Mean Difference|32.81|STANDARD_ERROR_OF_MEAN|2.288|<|0.0001|TWO_SIDED|95.0|28.27|37.34|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control.|Change from Baseline at Day 14||37.34|28.27|<0.0001
71116715|NCT05243745|141739942|SUPERIORITY||Adjusted Mean Difference|10.2|STANDARD_ERROR_OF_MEAN|2.485|<|0.0001|TWO_SIDED|95.0|5.28|15.13|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 28||15.13|5.28|<0.0001
71116716|NCT05243745|141739942|SUPERIORITY||Adjusted Mean Difference|13.92|STANDARD_ERROR_OF_MEAN|2.46|<|0.0001|TWO_SIDED|95.0|9.05|18.8|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 28||18.80|9.05|<0.0001
70940986|NCT02592434|141381824|SUPERIORITY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.61||0.1595|TWO_SIDED|95.0|-2.08|0.35|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.35|-2.08|0.1595
71116717|NCT05243745|141739942|SUPERIORITY||Adjusted Mean Difference|36.51|STANDARD_ERROR_OF_MEAN|2.568|<|0.0001|TWO_SIDED|95.0|31.42|41.6|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control.|Change from Baseline at Day 28||41.60|31.42|<0.0001
71116718|NCT05243745|141739942|SUPERIORITY||Adjusted Mean Difference|9.73|STANDARD_ERROR_OF_MEAN|2.761||0.0006|TWO_SIDED|95.0|4.26|15.2|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 56||15.20|4.26|0.0006
71116719|NCT05243745|141739942|SUPERIORITY||Adjusted Mean Difference|19.06|STANDARD_ERROR_OF_MEAN|2.772|<|0.0001|TWO_SIDED|95.0|13.57|24.55|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 56||24.55|13.57|<0.0001
71116720|NCT05243745|141739942|SUPERIORITY||Adjusted Mean Difference|39.33|STANDARD_ERROR_OF_MEAN|2.829|<|0.0001|TWO_SIDED|95.0|33.73|44.94|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control value.|Change from Baseline at Day 56||44.94|33.73|<0.0001
71116721|NCT01461928|141739991|SUPERIORITY||Hazard Ratio (HR)|0.76|||=|0.41|TWO_SIDED|95.0|0.37|1.53||Power at time of final analysis was less than 40%. Final analysis was not able to address its primary objective.|Stratified Long-rank|||The stratified log rank test p-value was derived using the following randomization stratification strata : Follicular Lymphoma International Prognostic Index (FLIPI) risk category (low, intermediate, high) and indolent NHL subtype (follicular lymphoma, non-follicular lymphoma). Power at time of final analysis was less than 40%. Final analysis was not able to address it's primary objective.||1.53|0.37|= 0.410
71116722|NCT01159171|141740003|SUPERIORITY_OR_OTHER|||||||0.0047||0.0||||One-sided p-value|One sample exact binomial test|||||||0.0047
71116723|NCT01018134|141740028|SUPERIORITY_OR_OTHER|||||||0.4261|||||||t-test, 1 sided|||||||0.4261
71116724|NCT01018134|141740028|SUPERIORITY_OR_OTHER|||||||0.4219|||||||t-test, 1 sided|||||||0.4219
71116725|NCT01018134|141740028|SUPERIORITY_OR_OTHER|||||||0.1826|||||||t-test, 1 sided|||||||0.1826
71116726|NCT01018134|141740028|SUPERIORITY_OR_OTHER|||||||0.009||||||Statistically significant difference between treatment groups|t-test, 1 sided|||||||0.0090
71116727|NCT01018134|141740028|SUPERIORITY_OR_OTHER|||||||0.3421|||||||t-test, 1 sided|||||||0.3421
71116728|NCT01018134|141740028|SUPERIORITY_OR_OTHER|||||||0.01||||||Statistically significant difference between treatment groups|t-test, 1 sided|||||||0.0100
71116729|NCT01018134|141740028|SUPERIORITY_OR_OTHER|||||||0.2103|||||||t-test, 1 sided|||||||0.2103
71116730|NCT01018134|141740028|SUPERIORITY_OR_OTHER|||||||0.12|||||||t-test, 1 sided|||||||0.1200
70940987|NCT02592434|141381824|SUPERIORITY||LS Mean difference|-1.42|STANDARD_ERROR_OF_MEAN|0.96||0.1421|TWO_SIDED|95.0|-3.32|0.48|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.48|-3.32|0.1421
71116731|NCT01018134|141740029|SUPERIORITY_OR_OTHER|||||||0.2631|||||||t-test, 1 sided|||||||0.2631
71116732|NCT01018134|141740029|SUPERIORITY_OR_OTHER|||||||0.2968|||||||t-test, 1 sided|||||||0.2968
71116733|NCT01018134|141740029|SUPERIORITY_OR_OTHER|||||||0.0186||||||statistically significant difference between treatment groups|t-test, 1 sided|||||||0.0186
71116734|NCT01018134|141740029|SUPERIORITY_OR_OTHER|||||||0.0361||||||statistically significant difference between treatment groups|t-test, 1 sided|||||||0.0361
71116735|NCT01018134|141740029|SUPERIORITY_OR_OTHER|||||||0.007||||||statistically significant difference between treatment groups|t-test, 1 sided|||||||0.0070
71116736|NCT01018134|141740029|SUPERIORITY_OR_OTHER|||||||0.1583|||||||t-test, 1 sided|||||||0.1583
71116737|NCT01018134|141740029|SUPERIORITY_OR_OTHER|||||||0.2078|||||||t-test, 1 sided|||||||0.2078
71116738|NCT01018134|141740029|SUPERIORITY_OR_OTHER|||||||0.2878|||||||t-test, 1 sided|||||||0.2878
71116739|NCT01018134|141740030|SUPERIORITY_OR_OTHER|||||||0.2713|||||||Wilcoxon (Mann-Whitney)|||||||0.2713
71116740|NCT01018134|141740030|SUPERIORITY_OR_OTHER|||||||0.2689|||||||Wilcoxon (Mann-Whitney)|||||||0.2689
71116741|NCT01018134|141740030|SUPERIORITY_OR_OTHER|||||||0.0419|||||||Wilcoxon (Mann-Whitney)|||||||0.0419
71116742|NCT01018134|141740030|SUPERIORITY_OR_OTHER|||||||0.0309|||||||Wilcoxon (Mann-Whitney)|||||||0.0309
71116743|NCT01018134|141740030|SUPERIORITY_OR_OTHER|||||||0.1126|||||||Wilcoxon (Mann-Whitney)|||||||0.1126
71116744|NCT01018134|141740030|SUPERIORITY_OR_OTHER|||||||0.0033|||||||Wilcoxon (Mann-Whitney)|||||||0.0033
71116745|NCT01018134|141740030|SUPERIORITY_OR_OTHER|||||||0.4967|||||||Wilcoxon (Mann-Whitney)|||||||0.4967
71116746|NCT01018134|141740030|SUPERIORITY_OR_OTHER|||||||0.0749|||||||Wilcoxon (Mann-Whitney)|||||||0.0749
71116747|NCT01018134|141740031|SUPERIORITY_OR_OTHER|||||||0.2442|||||||Wilcoxon (Mann-Whitney)|||||||0.2442
71116748|NCT01018134|141740031|SUPERIORITY_OR_OTHER|||||||0.2664|||||||Wilcoxon (Mann-Whitney)|||||||0.2664
71116749|NCT01018134|141740031|SUPERIORITY_OR_OTHER|||||||0.1328|||||||Wilcoxon (Mann-Whitney)|||||||0.1328
71116750|NCT01018134|141740031|SUPERIORITY_OR_OTHER|||||||0.0528|||||||Wilcoxon (Mann-Whitney)|||||||0.0528
71116751|NCT01018134|141740031|SUPERIORITY_OR_OTHER|||||||0.0297|||||||Wilcoxon (Mann-Whitney)|||||||0.0297
71116752|NCT01018134|141740031|SUPERIORITY_OR_OTHER|||||||0.0093|||||||Wilcoxon (Mann-Whitney)|||||||0.0093
71116753|NCT01018134|141740031|SUPERIORITY_OR_OTHER|||||||0.223|||||||Wilcoxon (Mann-Whitney)|||||||0.2230
71116754|NCT01018134|141740031|SUPERIORITY_OR_OTHER|||||||0.1924|||||||Wilcoxon (Mann-Whitney)|||||||0.1924
71116755|NCT01018134|141740032|SUPERIORITY_OR_OTHER|||||||0.2397|||||||Wilcoxon (Mann-Whitney)|||||||0.2397
71116756|NCT01018134|141740032|SUPERIORITY_OR_OTHER|||||||0.3794|||||||Wilcoxon (Mann-Whitney)|||||||0.3794
71116757|NCT01018134|141740032|SUPERIORITY_OR_OTHER|||||||0.0383|||||||Wilcoxon (Mann-Whitney)|||||||0.0383
71116758|NCT01018134|141740032|SUPERIORITY_OR_OTHER|||||||0.0154|||||||Wilcoxon (Mann-Whitney)|||||||0.0154
71116759|NCT01018134|141740032|SUPERIORITY_OR_OTHER|||||||0.1892|||||||Wilcoxon (Mann-Whitney)|||||||0.1892
71116760|NCT01018134|141740032|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.0010
71116761|NCT01018134|141740032|SUPERIORITY_OR_OTHER|||||||0.0363|||||||Wilcoxon (Mann-Whitney)|||||||0.0363
71116762|NCT01018134|141740032|SUPERIORITY_OR_OTHER|||||||0.2162|||||||Wilcoxon (Mann-Whitney)|||||||0.2162
71116763|NCT02222909|141740033|OTHER|The significance of the difference-in-differences statistic was assessed using randomization inference, a non-parametric permutation test. Confidence intervals were determined by inversion of the test statistic.|Difference in differences|0.0182||||0.63|TWO_SIDED|95.0|-0.12|0.11||We calculated the proportion of permuted statistics with values higher in magnitude than that of the observed adjusted difference in differences (the p-value). We inverted the test statistic to determine confidence intervals.|Randomization inference||The estimation parameter is the difference between the average adjusted change in the monthly ED visits and hospital days from the pre- to post- intervention periods for the patients assigned to the iCBOs as compared to the cCBOs.|The difference between the average sum of the number of days spent in the hospital and ED visits in the past month, pre- and post-intervention, adjusted for pre- intervention variables, was calculated for each patients. The average change scores among patients assigned to each CBO defined the CBO-level outcomes. We calculated a weighted average of the CBO outcomes separately for the iCBOs and cCBOs, defining the difference-in-differences statistic as the difference between the two averages.||0.11|-0.12|0.63
71116764|NCT01981863|141740036|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||||||0.21
71116765|NCT02242435|141740037|SUPERIORITY|||||||0.26||||||Adjusted for baseline WOMAC score.|ANCOVA|||||||0.26
71116766|NCT02242435|141740038|SUPERIORITY|||||||0.3||||||Adjustment for baseline WOMAC score.|ANCOVA|||||||0.30
71116767|NCT00117715|141740041|OTHER|||||||0.035||||||Post-hoc analysis performed using Tukey's Honestly Significant Difference test.|ANOVA|||Univariate analysis (ANOVA) of the change in log(DM/DX) over time||||0.035
71116768|NCT00117715|141740042|OTHER|||||||0.194||||||Post-hoc analysis performed using Tukey's Honestly Significant Difference test.|ANOVA|||Univariate analysis (ANOVA) of the change in log(3HM/DX) over time||||0.194
71116769|NCT00117715|141740043|OTHER|||||||0.831||||||Post-hoc analysis performed using Tukey's Honestly Significant Difference test.|ANOVA|||Univariate analysis (ANOVA) of the change in log ((AAMU+1MX+1MU)/1,7,U) over time||||0.831
71116770|NCT01089413|141740045|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.8579|TWO_SIDED|95.0|0.7|1.54|||Regression, Cox|||||1.54|0.70|0.8579
71116771|NCT01089413|141740046|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.1555|TWO_SIDED|95.0|0.3|1.21|||Regression, Cox|||||1.21|0.30|0.1555
71116772|NCT01971463|141740056|SUPERIORITY||||||<|0.05|||||||Wilcoxon signed rank|||Change in oCBF from baseline to post-bolus, ipsilesional hemisphere||||<0.05
71116773|NCT01971463|141740056|SUPERIORITY|Mixed effects regression, modeling the interaction term for time x normal saline bolus in the ipsilesional hemisphere|Slope|0.05|||<|0.001|TWO_SIDED|95.0|0.03|0.07|||Mixed Models Analysis|||||0.07|0.03|<0.001
71116774|NCT00420004|141740064|SUPERIORITY_OR_OTHER|||||||0.494|||||||Mixed Models Analysis|||||||0.494
71116775|NCT02456636|141740091|SUPERIORITY||Mean Difference (Net)|-1.87||||0.025|TWO_SIDED|97.5|-3.51|-0.23|||Mixed Models Analysis|||PCMH (in clinic group counseling) versus FFS (in clinic individual counseling)||-0.23|-3.51|.025
71116776|NCT02456636|141740091|SUPERIORITY||Mean Difference (Net)|-1.36||||0.25|TWO_SIDED|97.5|-3.0|0.29|||Mixed Models Analysis|||DM (phone group counseling) versus FFS (in clinic individual counseling)||0.29|-3.00|0.25
71116777|NCT02456636|141740091|SUPERIORITY||Mean Difference (Net)|-0.51||||0.025|TWO_SIDED|97.5|-2.15|1.13|||Mixed Models Analysis|||PCMH (in clinic group visits) versus DM (phone group visits)||1.13|-2.15|.025
71116778|NCT02456636|141740092|SUPERIORITY||Median Difference (Net)|-1.84||||0.025|TWO_SIDED|97.5|-3.5|-0.18|||Mixed Models Analysis|||PCMH (in clinic group counseling) versus FFS (in clinic individual counseling).||-0.18|-3.50|.025
71116779|NCT02456636|141740092|SUPERIORITY||Median Difference (Net)|-1.34||||0.025|TWO_SIDED|97.5|-2.99|0.32|||Mixed Models Analysis|||DM (phone group counseling) versus FFS (in clinic individual counseling)||0.32|-2.99|.025
71116780|NCT02456636|141740092|SUPERIORITY||Mean Difference (Net)|-0.5||||0.025|TWO_SIDED|97.5|-2.15|1.15|||Mixed Models Analysis|||PCMH (in clinic group counseling) versus DM (phone group counseling)||1.15|-2.15|.025
71116781|NCT01610557|141740112|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3||||0.039|TWO_SIDED|95.0|0.07|2.5|||Linear mixed-effects model||The difference represents the estimated difference between ranibizumab and bevacizumab, adjusted for baseline visual acuity, study period, and clinical site and a subject effect for eyes nested within subject.|||2.5|0.07|0.039
71116782|NCT01610557|141740113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-48.0|||<|0.001|TWO_SIDED|95.0|-65.0|-31.0|||Linear mixed-effects model||The difference represents the estimated difference between ranibizumab and bevacizumab, adjusted for baseline visual acuity, study period, and clinical site and a subject effect for eyes nested within subject.|||-31|-65|<0.001
71076291|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.897|||<|0.0001|TWO_SIDED|95.0|0.852|0.945|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.945|0.852|<0.0001
71076292|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.996||||0.0033|TWO_SIDED|95.0|1.259|3.165|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.165|1.259|0.0033
71076293|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.0095|TWO_SIDED|95.0|1.035|1.277|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.277|1.035|0.0095
71076294|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.155||||0.0031|TWO_SIDED|95.0|0.045|0.533|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.533|0.045|0.0031
71076295|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.364||||0.0645|TWO_SIDED|95.0|0.125|1.063|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.063|0.125|0.0645
71076296|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.895||||0.0001|TWO_SIDED|95.0|0.846|0.948|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.948|0.846|0.0001
71116783|NCT02039219|141740138|SUPERIORITY|The type of statistical test is superiority.|Mean Difference (Net)|1.5|STANDARD_DEVIATION|2.4||0.1758|TWO_SIDED|95.0|||||t-test, 2 sided||Two-sample t-test compared MELD score between OCA and placebo arms at baseline OCA arms had a mean (SD) of 14.9(2.4), Placebo arms had a mean (SD) of 16.4 (2.2).|Baseline||||0.1758
71116784|NCT02039219|141740138|SUPERIORITY|The type of statistical test is superiority.|Mean Difference (Net)|2.4|STANDARD_DEVIATION|6.8||0.3839|TWO_SIDED|95.0|||||t-test, 2 sided||Two-sample t-test compared MELD score between OCA and placebo arms at day 42 OCA arms had a mean (SD) of 11.5 (6.8), Placebo arms had a mean (SD) of 13.9(4.6).|Day 42||||0.3839
71116785|NCT02039219|141740146|SUPERIORITY|The type of statistical test is superiority.|Survival Anaylsis|0.0||||0.3938|ONE_SIDED||||||Log Rank|||Day 42||||.3938
71116786|NCT02039219|141740146|SUPERIORITY|The type of statistical test is superiority.|Survival Anaylsis|0.0||||0.3938|TWO_SIDED||||||Log Rank|||Day 90||||.3938
71116787|NCT02039219|141740146|SUPERIORITY|The type of statistical test is superiority.|Survival Anaylsis|0.0||||0.3938|TWO_SIDED||||||Log Rank|||Day 180||||.3938
71116788|NCT02039219|141740146|SUPERIORITY|The type of statistical test is superiority.|Survival Analysis|0.09||||0.3938|TWO_SIDED||||||Log Rank|||Day 42||||.3938
71116789|NCT02039219|141740146|SUPERIORITY|The type of statistical test is superiority.|Survival Analysis|0.09||||0.3938|TWO_SIDED||||||Log Rank|||Day 90||||.3938
71116790|NCT02039219|141740146|SUPERIORITY|The type of statistical test is superiority.|Survival Analysis|0.09||||0.3938|TWO_SIDED||||||Log Rank|||Day 180||||.3938
71116791|NCT02039219|141740150|SUPERIORITY|The type of statistical test is superiority.|Mean Difference (Final Values)|0.4|STANDARD_DEVIATION|2.5||0.8094|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.8094
71116792|NCT02974855|141740170|SUPERIORITY|Prophylactic treatment with PF-06741086 will be considered superior to On Demand treatment with respect to ABR reduction if 1) the upper limit of the 2-sided 80%CI of the ratio of ABR in PF/historical On Demand is \<1 and 2) the estimate of the ratio of ABR in PF/historical On Demand ≤0.3. Drug will be considered not superior to On Demand treatment if the lower limit of the 2-sided 80%CI of the ratio of PF/historical On Demand \>0.3.|ratio|0.15||||0.0002|TWO_SIDED|80.0|0.08|0.29|||Negative Binomial Model|||The comparator was the Historical on Demand Group||0.29|0.08|0.0002
71116793|NCT02974855|141740170|SUPERIORITY|Prophylactic treatment with PF-06741086 will be considered superior to On Demand treatment with respect to ABR reduction if 1) the upper limit of the 2-sided 80%CI of the ratio of ABR in PF/historical On Demand is \<1 and 2) the estimate of the ratio of ABR in PF/historical On Demand ≤0.3. Drug will be considered not superior to On Demand treatment if the lower limit of the 2-sided 80%CI of the ratio of PF/historical On Demand \>0.3.|ratio|0.05||||0.0001|TWO_SIDED|80.0|0.02|0.14|||Negative Binomial Model|||The comparator was the Historical on Demand Group||0.14|0.02|0.0001
71116794|NCT02974855|141740170|SUPERIORITY|Prophylactic treatment with PF-06741086 will be considered superior to On Demand treatment with respect to ABR reduction if 1) the upper limit of the 2-sided 80%CI of the ratio of ABR in PF/historical On Demand is \<1 and 2) the estimate of the ratio of ABR in PF/historical On Demand ≤0.3. Drug will be considered not superior to On Demand treatment if the lower limit of the 2-sided 80%CI of the ratio of PF/historical On Demand \>0.3.|ratio|0.15||||0.0002|TWO_SIDED|80.0|0.08|0.29|||Negative Binomial Model|||The comparator was the Historical on Demand Group||0.29|0.08|0.0002
71116795|NCT02974855|141740170|SUPERIORITY|Prophylactic treatment with PF-06741086 will be considered superior to On Demand treatment with respect to ABR reduction if 1) the upper limit of the 2-sided 80%CI of the ratio of ABR in PF/historical On Demand is \<1 and 2) the estimate of the ratio of ABR in PF/historical On Demand ≤0.3. Drug will be considered not superior to On Demand treatment if the lower limit of the 2-sided 80%CI of the ratio of PF/historical On Demand \>0.3.|ratio|0.03||||0.0005|TWO_SIDED|80.0|0.01|0.1|||Negative Binomial Model|||The comparator was the Historical on Demand Group||0.10|0.01|0.0005
71116796|NCT02974855|141740170|SUPERIORITY|Prophylactic treatment with PF-06741086 will be considered superior to On Demand treatment with respect to ABR reduction if 1) the upper limit of the 2-sided 80%CI of the ratio of ABR in PF/historical On Demand is \<1 and 2) the estimate of the ratio of ABR in PF/historical On Demand ≤0.3. Drug will be considered not superior to On Demand treatment if the lower limit of the 2-sided 80%CI of the ratio of PF/historical On Demand \>0.3.|ratio|0.09|||<|0.0001|TWO_SIDED|80.0|0.05|0.16|||Negative Binomial Model|||The comparator was the Historical on Demand Group||0.16|0.05|<0.0001
71116797|NCT02974855|141740170|SUPERIORITY||ratio|0.18|||<|0.0001|TWO_SIDED|80.0|0.11|0.31|||Negative Binomial Model|||On-Study versus Pre-Treatment||0.31|0.11|<0.0001
71116798|NCT02974855|141740170|SUPERIORITY||ratio|0.1||||0.0002|TWO_SIDED|80.0|0.04|0.22|||Negative Binomial Model|||On-Study versus Pre-Treatment||0.22|0.04|0.0002
71116799|NCT02974855|141740170|SUPERIORITY||ratio|0.2||||0.0154|TWO_SIDED|80.0|0.09|0.47|||Negative Binomial Model|||On-Study versus Pre-Treatment||0.47|0.09|0.0154
71116800|NCT02974855|141740170|SUPERIORITY||ratio|0.04||||0.0005|TWO_SIDED|80.0|0.01|0.14|||Negative Binomial Model|||On-Study versus Pre-Treatment||0.14|0.01|0.0005
71116801|NCT02974855|141740170|SUPERIORITY||ratio|0.12|||<|0.0001|TWO_SIDED|80.0|0.08|0.2|||Negative Binomial Model|||On-Study versus Pre-Treatment||0.20|0.08|<0.0001
71116802|NCT00129701|141740187|SUPERIORITY|||||||0.064|||||||Wilcoxon (Mann-Whitney)|||||||0.064
70940988|NCT02592434|141381824|SUPERIORITY||LS Mean difference|-1.66|STANDARD_ERROR_OF_MEAN|0.83||0.0552|TWO_SIDED|95.0|-3.37|0.04|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.04|-3.37|0.0552
71076297|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.996||||0.0033|TWO_SIDED|95.0|1.259|3.165|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.165|1.259|0.0033
71076298|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.0095|TWO_SIDED|95.0|1.035|1.277|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.277|1.035|0.0095
71076299|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.155||||0.0031|TWO_SIDED|95.0|0.045|0.533|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.533|0.045|0.0031
71076300|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.364||||0.0645|TWO_SIDED|95.0|0.125|1.063|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.063|0.125|0.0645
71076301|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.895||||0.0001|TWO_SIDED|95.0|0.846|0.948|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.948|0.846|0.0001
71076302|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.266||||0.0182|TWO_SIDED|95.0|1.041|1.541|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.541|1.041|0.0182
71076303|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.0092|TWO_SIDED|95.0|1.122|2.254|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.254|1.122|0.0092
71076304|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.974||||0.002|TWO_SIDED|95.0|1.488|5.942|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||5.942|1.488|0.0020
71076305|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.142||||0.6524|TWO_SIDED|95.0|0.641|2.035|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.035|0.641|0.6524
71076306|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.108|||<|0.0001|TWO_SIDED|95.0|0.037|0.311|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.311|0.037|<0.0001
71076307|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.389||||0.0429|TWO_SIDED|95.0|0.156|0.97|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.970|0.156|0.0429
71076308|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.549|TWO_SIDED|95.0|0.523|3.38|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.380|0.523|0.5490
71076309|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.136||||0.0008|TWO_SIDED|95.0|1.054|1.224|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.224|1.054|0.0008
71116803|NCT00608023|141740203|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
71116804|NCT00608023|141740204|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||ANCOVA|||||||>0.05
71116805|NCT00608023|141740205|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||ANCOVA|||||||>0.05
71116806|NCT00608023|141740206|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||ANCOVA|||||||>0.05
71116807|NCT00608023|141740207|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||ANCOVA|||||||>0.05
71116808|NCT03130439|141740229|OTHER||Objective Response Rate|0.0|||||TWO_SIDED|95.0|0.0|0.247||||||||0.247|0.000|
71116809|NCT03130439|141740232|OTHER||Disease Control Rate|0.222|||||TWO_SIDED|95.0|0.086|0.423||||||||0.423|0.086|
71116810|NCT03130439|141740233|OTHER||Clinical Benefit Rate|0.148|||||TWO_SIDED|95.0|0.042|0.337||||||||0.337|0.042|
70940989|NCT02592434|141381824|SUPERIORITY||LS Mean difference|-1.17|STANDARD_ERROR_OF_MEAN|0.63||0.0822|TWO_SIDED|95.0|-2.5|0.17|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.17|-2.50|0.0822
70940990|NCT02592434|141381824|SUPERIORITY||LS Mean difference|-3.98|STANDARD_ERROR_OF_MEAN|1.22||0.0041|TWO_SIDED|95.0|-6.53|-1.43|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-1.43|-6.53|0.0041
70940991|NCT02592434|141381824|SUPERIORITY||LS Mean difference|-3.57|STANDARD_ERROR_OF_MEAN|1.22||0.0085|TWO_SIDED|95.0|-6.12|-1.02|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-1.02|-6.12|0.0085
71076310|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.855||||0.014|TWO_SIDED|95.0|1.133|3.037|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.037|1.133|0.0140
70940992|NCT02592434|141381824|SUPERIORITY||LS Mean difference|-2.24|STANDARD_ERROR_OF_MEAN|1.03||0.0384|TWO_SIDED|95.0|-4.36|-0.13|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.13|-4.36|0.0384
70940993|NCT02592434|141381826|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.23||0.2595|TWO_SIDED|95.0|-0.72|0.19|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.19|-0.72|0.2595
71076311|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.126||||0.0575|TWO_SIDED|95.0|0.015|1.068|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.068|0.015|0.0575
71076312|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.7128|TWO_SIDED|95.0|0.072|6.025|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.025|0.072|0.7128
71076313|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.505||||0.596|TWO_SIDED|95.0|0.04|6.318|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.318|0.040|0.5960
71076314|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.051||||0.0033|TWO_SIDED|95.0|1.27|3.311|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.311|1.270|0.0033
71076315|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.113||||0.0452|TWO_SIDED|95.0|1.002|1.236|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.236|1.002|0.0452
71076316|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.154||||0.004|TWO_SIDED|95.0|0.043|0.551|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.551|0.043|0.0040
71076317|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.393||||0.0833|TWO_SIDED|95.0|0.137|1.131|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a||1.131|0.137|0.0833
71076318|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.141||||0.1439|TWO_SIDED|95.0|0.01|1.951|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.951|0.010|0.1439
70940994|NCT02592434|141381826|SUPERIORITY||LS Mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.37||0.0674|TWO_SIDED|95.0|-1.42|0.05|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.05|-1.42|0.0674
70940995|NCT02592434|141381826|SUPERIORITY||LS Mean difference|-0.95|STANDARD_ERROR_OF_MEAN|0.49||0.058|TWO_SIDED|95.0|-1.93|0.03|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.03|-1.93|0.0580
70940996|NCT02592434|141381826|SUPERIORITY||LS Mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.44||0.0751|TWO_SIDED|95.0|-1.67|0.08|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.08|-1.67|0.0751
70940997|NCT02592434|141381826|SUPERIORITY||LS Mean difference|-1.01|STANDARD_ERROR_OF_MEAN|0.43||0.0251|TWO_SIDED|95.0|-1.88|-0.13|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.13|-1.88|0.0251
70940998|NCT02592434|141381826|SUPERIORITY||LS Mean difference|-1.08|STANDARD_ERROR_OF_MEAN|0.49||0.0331|TWO_SIDED|95.0|-2.07|-0.09|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.09|-2.07|0.0331
70940999|NCT02592434|141381826|SUPERIORITY||LS Mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.42||0.0549|TWO_SIDED|95.0|-1.66|0.02|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.02|-1.66|0.0549
70941000|NCT02592434|141381828|SUPERIORITY||LS mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.25||0.0353|TWO_SIDED|95.0|-1.04|-0.04|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.04|-1.04|0.0353
70941001|NCT02592434|141381828|SUPERIORITY||LS Mean difference|-0.84|STANDARD_ERROR_OF_MEAN|0.32||0.0094|TWO_SIDED|95.0|-1.47|-0.21|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.21|-1.47|0.0094
70941002|NCT02592434|141381828|SUPERIORITY||LS Mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.28||0.0065|TWO_SIDED|95.0|-1.36|-0.23|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.23|-1.36|0.0065
70941003|NCT02592434|141381828|SUPERIORITY||LS Mean difference|-0.89|STANDARD_ERROR_OF_MEAN|0.27||0.0018|TWO_SIDED|95.0|-1.43|-0.34|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.34|-1.43|0.0018
71076319|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.35||||0.4457|TWO_SIDED|95.0|0.024|5.194|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||5.194|0.024|0.4457
71076320|NCT01066793|141661357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.142||||0.6258|TWO_SIDED|95.0|0.1|45.801|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||45.801|0.100|0.6258
71076321|NCT04591015|141661370|SUPERIORITY|||||||0.0626|||||||Fisher Exact|||||||0.0626
71076322|NCT04591015|141661371|SUPERIORITY|||||||0.0496|||||||t-test, 2 sided|||Only includes participants who completed a 90-day lab||||0.0496
71076323|NCT04591015|141661372|SUPERIORITY|||||||0.0651|||||||t-test, 2 sided|||Only includes participants who completed a 180-day lab||||0.0651
71076324|NCT04591015|141661373|SUPERIORITY|||||||0.8739|||||||Fisher Exact|||||||0.8739
71076325|NCT04591015|141661374|SUPERIORITY|||||||0.4702|||||||t-test, 2 sided|||||||0.4702
70941004|NCT02592434|141381828|SUPERIORITY||LS Mean difference|-1.42|STANDARD_ERROR_OF_MEAN|0.41||0.001|TWO_SIDED|95.0|-2.24|-0.61|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.61|-2.24|0.0010
70941005|NCT02592434|141381828|SUPERIORITY||LS Mean difference|-1.61|STANDARD_ERROR_OF_MEAN|0.4||0.0002|TWO_SIDED|95.0|-2.42|-0.81|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.81|-2.42|0.0002
70941006|NCT02592434|141381828|SUPERIORITY||LS Mean difference|-1.58|STANDARD_ERROR_OF_MEAN|0.43||0.0007|TWO_SIDED|95.0|-2.44|-0.71|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.71|-2.44|0.0007
71076326|NCT04591015|141661375|SUPERIORITY|||||||0.1258|||||||t-test, 2 sided|||||||0.1258
71076327|NCT04591015|141661376|SUPERIORITY|||||||0.8635|||||||t-test, 2 sided|||||||0.8635
71076328|NCT04591015|141661377|SUPERIORITY|||||||0.0471|||||||t-test, 2 sided|||||||0.0471
71076329|NCT04591015|141661378|SUPERIORITY|||||||0.0218|||||||t-test, 2 sided|||||||0.0218
71076330|NCT04591015|141661379|SUPERIORITY|||||||0.509|||||||t-test, 2 sided|||||||0.5090
71076331|NCT04591015|141661380|SUPERIORITY|||||||0.4034|||||||t-test, 2 sided|||||||0.4034
71076332|NCT04591015|141661381|SUPERIORITY|||||||0.0175|||||||t-test, 2 sided|||||||0.0175
71076333|NCT04591015|141661382|SUPERIORITY|||||||0.4435|||||||Fisher Exact|||||||0.4435
71076334|NCT04591015|141661383|SUPERIORITY|||||||0.7417|||||||Fisher Exact|||||||0.7417
71076335|NCT04591015|141661384|SUPERIORITY|||||||0.5779|||||||t-test, 2 sided|||||||0.5779
71076336|NCT04591015|141661385|SUPERIORITY|||||||0.0493|||||||t-test, 2 sided|||||||0.0493
71076337|NCT04591015|141661386|SUPERIORITY|||||||0.0773|||||||t-test, 2 sided|||||||0.0773
71076338|NCT04591015|141661387|SUPERIORITY|||||||0.0921|||||||t-test, 2 sided|||||||0.0921
71076339|NCT04591015|141661388|SUPERIORITY|||||||0.2404|||||||t-test, 2 sided|||||||0.2404
71076340|NCT04591015|141661389|SUPERIORITY|||||||0.8955|||||||t-test, 2 sided|||||||0.8955
71076341|NCT02509078|141661390|SUPERIORITY||Risk Difference (RD)|-0.3||||0.93|TWO_SIDED|95.0|-6.4|5.9|||Wald test for the difference of two prop||Estimated value is a percentage|||5.9|-6.4|0.93
71076342|NCT02686814|141661421|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|-0.9||||0.7646|TWO_SIDED||||||Wilcoxon signed-rank test|||3-6 Month compared to Baseline||||0.7646
71076343|NCT02686814|141661421|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|3.9||||0.8984|TWO_SIDED||||||Wilcoxon signed-rank test|||1 Year compared to Baseline||||0.8984
70941007|NCT02592434|141381830|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.2||0.0398|TWO_SIDED|95.0|-0.83|-0.02|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.02|-0.83|0.0398
70941008|NCT02592434|141381830|SUPERIORITY||LS Mean difference|-0.94|STANDARD_ERROR_OF_MEAN|0.28||0.0011|TWO_SIDED|95.0|-1.49|-0.39|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.39|-1.49|0.0011
70941009|NCT02592434|141381830|SUPERIORITY||LS mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.32||0.0131|TWO_SIDED|95.0|-1.47|-0.18|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.18|-1.47|0.0131
71116811|NCT00123162|141740237|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.3|||<|0.001|TWO_SIDED|95.0|2.9|7.6|||ANCOVA|adjusted for baseline pain intensity (Visual Analog Scale (VAS) score).||With 26 subjects per treatment group and an assumed within-group standard deviation of 7 units, the study was designed to have 90% statistical power for a two-sided, 0.05 significance level test to detect a difference of 6.5 units in TOPAR4 between a single dose of 100 mg of sildenafil and placebo. However, we anticipated subject drop-out as high as 15%; therefore, we planned to recruit 31 subjects per treatment group.||7.6|2.9|<0.001
70941010|NCT02592434|141381830|SUPERIORITY||LS mean difference|-0.97|STANDARD_ERROR_OF_MEAN|0.32||0.0039|TWO_SIDED|95.0|-1.62|-0.33|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.33|-1.62|0.0039
71116812|NCT00123162|141740238|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-42.6|||<|0.001|TWO_SIDED|95.0|-58.3|-26.8|||Mixed Models Analysis||Comparison of the VAS score at hour 4 (Sildenafil Citrate - Placebo)|||-26.8|-58.3|<.001
71116813|NCT04838054|141740239|SUPERIORITY||Mean Difference (Net)|0.27||||0.28|TWO_SIDED|||||p-values \<0.05 means statistically significant|ANCOVA|||||||0.28
71116814|NCT04838054|141740240|SUPERIORITY||Mean Difference (Net)|0.41||||0.011|TWO_SIDED|||||p\<0.05 means statistically significant|ANCOVA|||||||0.011
71116815|NCT04838054|141740241|SUPERIORITY||Mean Difference (Net)|2.99|||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
71116816|NCT00729677|141740242|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||.05
71116817|NCT01126437|141740277|NON_INFERIORITY_OR_EQUIVALENCE|Three tests were conducted in hierarchical order. Non-inferiority of time to death from any cause was tested on the two Respimat doses: Tio R 5 vs. Tio HH18, then if non-inferiority was achieved Tio R 2.5 vs Tio HH18. If successful, a test of superiority of Tio R5 over Tio HH18 for time to first COPD exacerbation was conducted. The non-inferiority delta for time to death was 1.25. Non-inferiority tests were performed at one-sided α=0.025 level. Superiority test was performed at two sided α=0.05.|Hazard Ratio (HR)|0.957|||||TWO_SIDED|95.0|0.837|1.094|||Regression, Cox|||H0: Hazard Ratio for Respimat/HandiHaler \>= 1.25 Ha: Hazard Ratio for Respimat/HandiHaler \< 1.25||1.094|0.837|
71116818|NCT01126437|141740277|NON_INFERIORITY_OR_EQUIVALENCE|Three tests were conducted in hierarchical order. Non-inferiority of time to death from any cause was tested on the two Respimat doses: Tio R 5 vs. Tio HH18, then if non-inferiority was achieved Tio R 2.5 vs Tio HH18. If successful, a test of superiority of Tio R5 over Tio HH18 for time to first COPD exacerbation was conducted. The non-inferiority delta for time to death was 1.25. Non-inferiority tests were performed at one-sided α=0.025 level. Superiority test was performed at two sided α=0.05.|Hazard Ratio (HR)|0.996|||||TWO_SIDED|95.0|0.872|1.136|||Regression, Cox|||H0: Hazard Ratio for Respimat/HandiHaler \>= 1.25 Ha: Hazard Ratio for Respimat/HandiHaler \< 1.25||1.136|0.872|
70941011|NCT02592434|141381830|SUPERIORITY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.29||0.0711|TWO_SIDED|95.0|-1.1|0.05|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.05|-1.10|0.0711
70941012|NCT02592434|141381830|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.34||0.0658|TWO_SIDED|95.0|-1.3|0.04|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.04|-1.30|0.0658
70941013|NCT02592434|141381830|SUPERIORITY||LS mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.29||0.0154|TWO_SIDED|95.0|-1.31|-0.15|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.15|-1.31|0.0154
70941014|NCT02592434|141381832|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.04||0.4777|TWO_SIDED|95.0|-0.12|0.06|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.06|-0.12|0.4777
71076344|NCT02686814|141661421|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|0.0||||0.8457|TWO_SIDED||||||Wilcoxon signed-rank test|||2 Year compared to Baseline||||0.8457
71076345|NCT02686814|141661421|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|-7.7||||0.1309|TWO_SIDED||||||Wilcoxon signed-rank test|||3 Year compared to Baseline||||0.1309
71076346|NCT02686814|141661421|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|-15.2||||0.5|TWO_SIDED||||||Wilcoxon signed-rank test|||4 Year compared to Baseline||||0.5000
71116819|NCT01126437|141740278|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.978||||0.4194|TWO_SIDED|95.0|0.928|1.032|||Regression, Cox|||"H0: Hazard Ratio for Respimat/HandiHaler = 1 Ha: Hazard Ratio for Respimat/HandiHaler ≠ 1~at alpha = 0.05"||1.032|0.928|0.4194
71116820|NCT01126437|141740278|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.016||||0.5593|TWO_SIDED|95.0|0.964|1.07|||Regression, Cox|||"H0: Hazard Ratio for Respimat/HandiHaler = 1 Ha: Hazard Ratio for Respimat/HandiHaler ≠ 1~at alpha = 0.05"||1.070|0.964|0.5593
71076347|NCT02686814|141661422|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|1.5||||0.2783|TWO_SIDED||||||Wilcoxon signed-rank test|||3-6 Month compared to Baseline||||0.2783
71076348|NCT02686814|141661422|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|6.4||||0.0674|TWO_SIDED||||||Wilcoxon signed-rank test|||1 Year compared to Baseline||||0.0674
71076349|NCT02686814|141661422|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|6.4||||0.0371|TWO_SIDED||||||Wilcoxon signed-rank test|||2 Year compared to Baseline||||0.0371
71076350|NCT02686814|141661422|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|0.8||||0.6953|TWO_SIDED||||||Wilcoxon signed-rank test|||3 Year compared to Baseline||||0.6953
71076351|NCT02686814|141661422|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|1.0|||>|0.9999|TWO_SIDED||||||Wilcoxon signed-rank test|||4 Year compared to Baseline||||>0.9999
71076352|NCT02635009|141661483|SUPERIORITY|||||||0.28|||||||Fisher Exact|one-sided significance level = 0.05||Proportion of participants with deterioration in HVLT-R delayed recall score at six months: Null hypothesis = No difference between the arms; Alternative hypothesis = Arm 2 will have less deterioration than Arm 1. Ninety-eight evaluable participants per arm at six months provides 80% statistical power to detect a 14.5% absolute difference between the arms in proportion of participants with deterioration at six months using a one-sided Fisher's exact test.||||0.28
71076353|NCT02635009|141661484|NON_INFERIORITY|Null hypothesis: Proportion of participants with relapse on Arm 2 - Arm 1 \> 20%; Alternative hypothesis: Proportion of participants with relapse on Arm 2 - Arm 1 = 4.5%. Using a non-inferiority margin of 20% and an assumed difference in proportions of 4.5% under the alternative, a 2-sample test of difference in proportions with a 1-sided alpha of 0.1 requires 164 patients to achieve 85% statistical power. (Statistically significant p-value indicates non-inferiority.)||||||0.003|||||||Test of binomial proportions|||||||0.0030
71076354|NCT02635009|141661485|SUPERIORITY|||||||0.0598|||||||Gray's test|||||||0.0598
71076355|NCT02635009|141661486|SUPERIORITY|||||||0.78|||||||Chi-squared|||3 months||||0.78
71076356|NCT02635009|141661486|SUPERIORITY|||||||0.63|||||||Chi-squared|||6 months||||0.63
71076357|NCT02635009|141661486|SUPERIORITY|||||||0.84|||||||Chi-squared|||12 months||||0.84
71076358|NCT02635009|141661488|SUPERIORITY|||||||0.56|||||||Chi-squared|||3 months||||0.56
71076359|NCT02635009|141661488|SUPERIORITY|||||||0.75|||||||Chi-squared|||12 months||||0.75
71076360|NCT02635009|141661490|SUPERIORITY|||||||0.81|||||||Chi-squared|||3 months||||0.81
71076361|NCT02635009|141661490|SUPERIORITY|||||||0.93|||||||Chi-squared|||6 months||||0.93
71076362|NCT02635009|141661490|SUPERIORITY|||||||0.35|||||||Chi-squared|||12 months||||0.35
71116821|NCT01126437|141740278|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.038||||0.1639|TWO_SIDED|95.0|0.985|1.094|||Regression, Cox|||"H0: Hazard Ratio for Respimat/HandiHaler = 1 Ha: Hazard Ratio for Respimat/HandiHaler ≠ 1~at alpha = 0.05"||1.094|0.985|0.1639
71076363|NCT02635009|141661492|SUPERIORITY|||||||0.54|||||||Chi-squared|||3 months||||0.54
71076364|NCT02635009|141661492|SUPERIORITY|||||||0.43|||||||Chi-squared|||6 months||||0.43
71076365|NCT02635009|141661492|SUPERIORITY|||||||0.25|||||||Chi-squared|||12 months||||0.25
71076366|NCT02635009|141661494|SUPERIORITY|||||||0.71|||||||Chi-squared|||3 months||||0.71
71076367|NCT02635009|141661494|SUPERIORITY|||||||0.079|||||||Chi-squared|||6 months||||0.079
71076368|NCT02635009|141661494|SUPERIORITY|||||||0.85|||||||Chi-squared|||12 months||||0.85
71076369|NCT02635009|141661496|SUPERIORITY|||||||0.043|||||||Chi-squared|||3 months||||0.043
71076370|NCT02635009|141661496|SUPERIORITY|||||||0.017|||||||Fisher Exact|||6 months||||0.017
71076371|NCT02635009|141661496|SUPERIORITY|||||||0.057|||||||Chi-squared|||12-month||||0.057
71076372|NCT02635009|141661499|SUPERIORITY|||||||0.1|||||||Chi-squared|||3 months||||0.10
71076373|NCT02635009|141661499|SUPERIORITY|||||||0.33|||||||Chi-squared|||6 months||||0.33
71076374|NCT02635009|141661499|SUPERIORITY|||||||0.29|||||||Chi-squared|||12 months||||0.29
71076375|NCT02635009|141661501|SUPERIORITY|||||||0.0021|||||||Chi-squared|||3 months||||0.0021
71076376|NCT02635009|141661501|SUPERIORITY|||||||0.007|||||||Chi-squared|||6 months||||0.0070
71076377|NCT02635009|141661501|SUPERIORITY|||||||0.35|||||||Chi-squared|||12 months||||0.35
71076378|NCT02635009|141661503|SUPERIORITY|||||||0.55|||||||Chi-squared|||3 months||||0.55
71076379|NCT02635009|141661503|SUPERIORITY|||||||0.062|||||||Chi-squared|||6 months||||0.062
71076380|NCT02635009|141661503|SUPERIORITY|||||||0.32|||||||Chi-squared|||12 months||||0.32
71076381|NCT02635009|141661505|SUPERIORITY|||||||0.7|||||||Chi-squared|||3 months||||0.70
71076382|NCT02635009|141661505|SUPERIORITY|||||||0.52|||||||Chi-squared|||6 months||||0.52
71076383|NCT02635009|141661505|SUPERIORITY|||||||0.73|||||||Chi-squared|||12 months||||0.73
71076384|NCT02635009|141661507|SUPERIORITY|||||||0.28|||||||Chi-squared|||3 months||||0.28
71076385|NCT02635009|141661507|SUPERIORITY|||||||0.094|||||||Chi-squared|||6 months||||0.094
71076386|NCT02635009|141661507|SUPERIORITY|||||||0.61|||||||Chi-squared|||||||0.61
71076387|NCT02635009|141661509|SUPERIORITY|||||||0.16|||||||Chi-squared|||3 months.||||0.16
70941015|NCT02592434|141381832|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.04||0.0779|TWO_SIDED|95.0|-0.16|0.01|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.01|-0.16|0.0779
71076388|NCT02635009|141661509|SUPERIORITY|||||||0.017|||||||Chi-squared|||6 months. Assuming 50% of patients experience deterioration at 6 months, based on a prior study (RTOG-0212), a sample size of 198 participants per arm provides 94% power to detect a 50% relative reduction (50% on Arm 1 vs. 25% on Arm 2) in decline at 6 months using Fisher's exact test with a two-sided alpha=0.05.||||0.017
71076389|NCT02635009|141661509|SUPERIORITY|||||||0.56|||||||Chi-squared|||12-month||||0.56
71076390|NCT02635009|141661511|SUPERIORITY|||||||0.44|||||||Chi-squared|||||||0.44
71076391|NCT02635009|141661511|SUPERIORITY|||||||0.45|||||||Chi-squared|||||||0.45
71076392|NCT02635009|141661511|SUPERIORITY|||||||0.25|||||||Chi-squared|||||||0.25
71076393|NCT02635009|141661513|SUPERIORITY|||||||0.35|||||||Chi-squared|||3 months||||0.35
71076394|NCT02635009|141661513|SUPERIORITY|||||||0.99|||||||Chi-squared|||6 months||||0.99
71076395|NCT02635009|141661513|SUPERIORITY|||||||0.94|||||||Chi-squared|||12 months||||0.94
71076396|NCT02635009|141661517|SUPERIORITY|||||||0.79||||||Two-side significance level = 0.05|Log Rank|||||||0.79
71076397|NCT02635009|141661518|SUPERIORITY|||||||0.93|||||||Gray's test|||||||0.93
71076398|NCT02636699|141661520|OTHER||Difference in Response Rates (%)|21.7|||<|0.001|TWO_SIDED|95.0|12.4|29.8|||Wald|||Analysis of the difference in response rates between DBV712 250 μg group and Placebo group and 2-sided Newcombe 95% confidence interval (CI). P-value was obtained from a 2-sided 5% test to evaluate the null hypothesis of no difference in response rates between treatment groups using the Wald method. Clinical relevance was evaluated based on the lower bound of the Newcombe 95% CI of the difference in response rates ≥15%.||29.8|12.4|<0.001
71076399|NCT02636699|141661521|OTHER||Difference in Response Rates (%)|19.0||||0.105|TWO_SIDED|95.0|-6.4|38.4|||Wald|||"Screening ED subgroup 1:~Analysis of the difference in response rates between DBV712 250 μg group and Placebo group and 2-sided Newcombe 95% CI. P-value was obtained from a 2-sided 5% test to evaluate the null hypothesis of no difference in response rates between treatment groups using the Wald method. Clinical relevance was evaluated based on the lower bound of the Newcombe 95% CI of the difference in response rates \>0."||38.4|-6.4|0.105
71076400|NCT02636699|141661521|OTHER||Difference in Response Rates (%)|22.3|||<|0.001|TWO_SIDED|95.0|12.1|30.8|||Wald|||"Screening ED subgroup 2:~Analysis of the difference in response rates between DBV712 250 μg group and Placebo group and 2-sided Newcombe 95% CI. P-value was obtained from a 2-sided 5% test to evaluate the null hypothesis of no difference in response rates between treatment groups using the Wald method. Clinical relevance was evaluated based on the lower bound of the Newcombe 95% CI of the difference in response rates \>0."||30.8|12.1|<0.001
71076401|NCT02636699|141661522|OTHER||Difference in Median CRD|297.0|||<|0.001|TWO_SIDED|95.0|130.0|317.0|||Wilcoxon rank-sum test|||The treatment effect was estimated using the Hodges-Lehmann estimate of the difference in median CRDs at Month 12.||317.0|130.0|<0.001
71076402|NCT01973335|141661525|SUPERIORITY||Mean Difference (Final Values)|30.0||||0.515|TWO_SIDED|95.0|-63.0|123.0||Not adjusted for multiple comparisons|t-test, 2 sided|||2x2 factorial design: both acetazolamide groups together are compared with both high-dose loop diuretic groups together||123|-63|0.515
70941016|NCT02592434|141381832|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.05||0.0324|TWO_SIDED|95.0|-0.19|-0.01|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.01|-0.19|0.0324
71076403|NCT01973335|141661526|SUPERIORITY||Risk Difference (RD)|-0.2||||0.27|TWO_SIDED|||||Not adjusted for multiple comparisons|Fisher Exact|||2x2 factorial design: analysis according to spironolactone use||||0.270
71076404|NCT01636947|141661546|SUPERIORITY_OR_OTHER|||||||0.191|||||||Pearson's chi-square test|||||||0.191
71076405|NCT01636947|141661547|SUPERIORITY_OR_OTHER|||||||0.458|||||||Pearson's chi-square test|||Overall Stage p-value||||0.458
71076406|NCT02603107|141661568|NON_INFERIORITY|A sample size of 520 participants (260 participants per treatment group) would provide at least 90% power to establish a non-inferiority margin of 4% in the Week 48 response rate (HIV-1 RNA ≥ 50 copies/mL) between the 2 treatment groups. Sample size was based on the assumptions that both treatment groups have 2% of participants with HIV-1 RNA ≥ 50 copies/mL (based on Gilead Genvoya and Stribild studies) and that the significance level of the test is at a 1-sided 0.025 level.|Difference in Percentages|0.0|||||TWO_SIDED|95.002|-2.5|2.5|||||The difference in percentages and its 95.002% confidence interval (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The null hypothesis was that the percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 in the B/F/TAF group was at least 4% higher than the rate in the SBR group; the alternative hypothesis was that the percentage of participants with HIV-1 RNA ≥ 50 copies/mL in the B/F/TAF group was less than 4% higher than that in the SBR group.||2.5|-2.5|
71076407|NCT02603107|141661568|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71076408|NCT02603107|141661569|NON_INFERIORITY|The non-inferiority of B/F/TAF would be established if the lower bound of the 2-sided 95.002% CI of the difference between the treatment groups (B/F/TAF group - SBR group) in the percentage of participants with HIV-1 RNA \< 50 copies/mL is greater than -10%.|Difference in Percentages|3.2|||||TWO_SIDED|95.002|-1.6|8.2|||||The difference in percentages and its 95.002% confidence interval (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|||8.2|-1.6|
71076409|NCT02603107|141661569|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.20
71076410|NCT02603107|141661570|SUPERIORITY||Difference in Least Squares Means (LSM)|25.0||||0.068|TWO_SIDED|95.0|-2.0|52.0|||ANOVA|||||52|-2|0.068
71076411|NCT03411902|141661572|SUPERIORITY|||||||0.048|||||||Mixed Models Analysis|||||||0.048
71076412|NCT03411902|141661573|SUPERIORITY|||||||0.745|||||||Mixed Models Analysis|||||||0.745
71076413|NCT03411902|141661574|SUPERIORITY|||||||0.163|||||||Mixed Models Analysis|||||||0.163
70941017|NCT02592434|141381832|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.06||0.1061|TWO_SIDED|95.0|-0.2|0.02|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.02|-0.20|0.1061
70941018|NCT02592434|141381832|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.06||0.0572|TWO_SIDED|95.0|-0.24|0.0|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.00|-0.24|0.0572
70941019|NCT02592434|141381832|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.0689|TWO_SIDED|95.0|-0.24|0.01|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.01|-0.24|0.0689
70941020|NCT02592434|141381832|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0292|TWO_SIDED|95.0|-0.22|-0.01|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.01|-0.22|0.0292
71076414|NCT03411902|141661575|SUPERIORITY|||||||0.013|||||||Mixed Models Analysis|||||||0.013
71076415|NCT03411902|141661576|SUPERIORITY|||||||0.337|||||||Mixed Models Analysis|||Pertaining to Radius 33 BMD||||0.337
71076416|NCT03411902|141661576|SUPERIORITY|||||||0.238|||||||Mixed Models Analysis|||Pertaining to Radius UD BMD||||0.238
71076417|NCT03411902|141661577|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|||||||0.860
71076418|NCT00419159|141661583|OTHER||Odds Ratio (OR)|1.8||||0.253|TWO_SIDED|95.0|0.657|4.929|||Unadjusted Logistic Regression|||||4.929|0.657|0.253
71076419|NCT00419159|141661584|OTHER||Odds Ratio (OR)|0.382||||0.07|TWO_SIDED|95.0|0.135|1.083|||Unadjusted Logistic Regression|||||1.083|0.135|0.070
71076420|NCT00419159|141661585|OTHER||Hazard Ratio (HR)|0.814||||0.399|TWO_SIDED|95.0|0.505|1.312|||Unadjusted Logistic Regression|||||1.312|0.505|0.399
71076421|NCT00419159|141661585|OTHER||Hazard Ratio, log|1.001||||0.995|TWO_SIDED|95.0|0.62|1.617|||Unadjusted Logistic Regression|||||1.617|0.620|0.995
71076422|NCT00419159|141661586|OTHER||Hazard Ratio, log|1.203||||0.441|TWO_SIDED|95.0|0.752|1.923|||Unadjusted Logistic Regression|||||1.923|0.752|0.441
71076423|NCT00419159|141661586|OTHER||Hazard Ratio, log|1.547||||0.126|TWO_SIDED|95.0|0.884|2.708|||Unadjusted Logistic Regression|||||2.708|0.884|0.126
71076424|NCT00419159|141661587|OTHER||Odds Ratio (OR)|0.529||||0.238|TWO_SIDED|95.0|0.184|1.523|||Unadjusted Logistic Regression|||||1.523|0.184|0.238
71076425|NCT00419159|141661588|OTHER||Odds Ratio (OR)|1.044||||0.938|TWO_SIDED|95.0|0.352|3.099|||Unadjusted Logistic Regression|||||3.099|0.352|0.938
71076426|NCT00419159|141661589|OTHER||Hazard Ratio (HR)|1.474||||0.145|TWO_SIDED|95.0|0.875|2.484|||Unadjusted Cox Model|||||2.484|0.875|0.145
71117729|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-57.01|||<|0.001|TWO_SIDED|95.0|-73.27|-40.76||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-40.76|-73.27|<0.001
70853688|NCT00759564|141195499|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|285.05|||||TWO_SIDED|90.0|221.8|366.33||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||366.33|221.80|
71076427|NCT00419159|141661589|OTHER||Hazard Ratio, log|1.151||||0.583|TWO_SIDED|95.0|0.696|1.903|||Unadjusted Cox Model|||||1.903|0.696|0.583
71076428|NCT00419159|141661590|OTHER||Hazard Ratio (HR)|0.868||||0.588|TWO_SIDED|95.0|0.521|1.447|||Unadjusted Cox Model|||||1.447|0.521|0.588
71076429|NCT00419159|141661590|OTHER||Hazard Ratio (HR)|0.611||||0.148|TWO_SIDED|95.0|0.314|1.191|||Unadjusted Cox Model|||||1.191|0.314|0.148
71076430|NCT01017601|141661596|OTHER|||||||0.5|||||||Wilcoxon Rank Sum|||||||0.50
71076431|NCT01017601|141661597|OTHER|||||||0.96|||||||Wilcoxon Rank Sum|||||||0.96
71076432|NCT01017601|141661598|OTHER|||||||0.54|||||||Fisher Exact|||||||0.54
71076433|NCT01017601|141661599|OTHER|||||||1|||||||Fisher Exact|||||||1.0
71076434|NCT02051335|141661600|SUPERIORITY_OR_OTHER||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.556||0.573|TWO_SIDED|95.0|-1.4|0.8||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||0.8|-1.4|0.573
71076435|NCT02051335|141661600|SUPERIORITY_OR_OTHER||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.55||0.21|TWO_SIDED|95.0|-1.8|0.4||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||0.4|-1.8|0.210
71076436|NCT02051335|141661600|SUPERIORITY_OR_OTHER||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.547||0.821|TWO_SIDED|95.0|-1.0|1.2||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||1.2|-1.0|0.821
71076437|NCT02051335|141661600|SUPERIORITY_OR_OTHER||LS mean difference|0.44|STANDARD_ERROR_OF_MEAN|0.549||0.426|TWO_SIDED|95.0|-0.7|1.5||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||1.5|-0.7|0.426
71076438|NCT02051335|141661600|SUPERIORITY_OR_OTHER||LS mean difference|0.82|STANDARD_ERROR_OF_MEAN|0.53||0.126|TWO_SIDED|95.0|-0.2|1.9||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||1.9|-0.2|0.126
71076439|NCT02051335|141661601|SUPERIORITY_OR_OTHER||LS mean difference|1.93|STANDARD_ERROR_OF_MEAN|0.992||0.057|TWO_SIDED|95.0|-0.1|3.9||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||3.9|-0.1|0.057
71076440|NCT02051335|141661601|SUPERIORITY_OR_OTHER||LS mean difference|-0.84|STANDARD_ERROR_OF_MEAN|0.981||0.394|TWO_SIDED|95.0|-2.8|1.1||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||1.1|-2.8|0.394
70941021|NCT02592434|141381834|SUPERIORITY||LS Mean Difference|3.79|STANDARD_ERROR_OF_MEAN|3.77||0.3179|TWO_SIDED|95.0|-3.72|11.31|||MMRM|||Global Health: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||11.31|-3.72|0.3179
70941022|NCT02592434|141381834|SUPERIORITY||LS mean difference|3.28|STANDARD_ERROR_OF_MEAN|4.27||0.4452|TWO_SIDED|95.0|-5.23|11.78|||MMRM|||Physical Functioning: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||11.78|-5.23|0.4452
71116822|NCT01126437|141740279|NON_INFERIORITY_OR_EQUIVALENCE|The first test performed was to test the main effect for treatment in the mixed model repeated measures (MMRM) model, specifically the 95% CI for the contrast between Tio R 5ug and Tio HH 18ug was compared to the non-inferiority delta of 50 mL. If that test was successful, the second test in the hierarchy was to test the main effect for treatment in the MMRM model, specifically the 95% CI for the contrast between Tio R 2.5 ug and Tio HH 18 ug was compared to the non-inferiority delta of 50 mL.|Adjusted mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.014|||TWO_SIDED|95.0|-0.038|0.018||An autoregression-1 covariance structure modeled the within-subject errors because visits were equally spaced. The Kenward-Roger approximation estimated denominator degrees of freedom.|Mixed Model Repeated Measures||Model included the fixed, categorical effects of treatment, investigative site, visit, and treatment-by-visit interaction, and continuous, fixed covariates of baseline and baseline-by-visit interaction, and a random term of patient.|"FEV1 was analyzed through Week 120 using REML-based repeated measures.~H0: Adjusted mean difference for Respimat/HandiHaler ≥ 50ml Ha: Adjusted mean difference for Respimat/HandiHaler \< 50 ml"||0.018|-.038|
71116823|NCT01126437|141740279|NON_INFERIORITY_OR_EQUIVALENCE|The first test performed was to test the main effect for treatment in the mixed model repeated measures (MMRM) model, specifically the 95% CI for the contrast between Tio R 5ug and Tio HH 18ug was compared to the non-inferiority delta of 50 mL. If that test was successful, the second test in the hierarchy was to test the main effect for treatment in the MMRM model, specifically the 95% CI for the contrast between Tio R 2.5 ug and Tio HH 18 ug was compared to the non-inferiority delta of 50 mL.|Adjusted mean difference|-0.037|STANDARD_ERROR_OF_MEAN|0.014|||TWO_SIDED|95.0|-0.065|-0.009||An autoregression-1 covariance structure modeled the within-subject errors because visits were equally spaced. The Kenward-Roger approximation estimated denominator degrees of freedom.|Mixed Model Repeated Measures||Model included the fixed, categorical effects of treatment, investigative site, visit, and treatment-by-visit interaction, and continuous, fixed covariates of baseline and baseline-by-visit interaction, and a random term of patient.|"FEV1 was analyzed through Week 120 using REML-based repeated measures.~H0: Adjusted mean difference for Respimat/HandiHaler ≥ 50ml Ha: Adjusted mean difference for Respimat/HandiHaler \< 50 ml"||-.009|-.065|
71116824|NCT01126437|141740280|SUPERIORITY_OR_OTHER||Rate ratio of events|1.01|STANDARD_ERROR_OF_MEAN|0.03||0.833|TWO_SIDED|95.0|0.95|1.06|||Negative binomial regression|||||1.06|0.95|0.8330
71116825|NCT01126437|141740280|SUPERIORITY_OR_OTHER||Rate ratio of events|0.99|STANDARD_ERROR_OF_MEAN|0.03||0.8047|TWO_SIDED|95.0|0.94|1.05|||Negative binomial regression|||||1.05|0.94|0.8047
71116826|NCT01126437|141740280|SUPERIORITY_OR_OTHER||Rate ratio of events|1.01|STANDARD_ERROR_OF_MEAN|0.03||0.6468|TWO_SIDED|95.0|0.96|1.07|||Negative binomial regression|||||1.07|0.96|0.6468
71116827|NCT01126437|141740281|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.068||||0.1762|TWO_SIDED|95.0|0.971|1.176|||Regression, Cox|||||1.176|0.971|0.1762
71116828|NCT01126437|141740281|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.024||||0.6384|TWO_SIDED|95.0|0.929|1.128|||Regression, Cox|||||1.128|0.929|0.6384
71116829|NCT01126437|141740281|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.044||||0.3784|TWO_SIDED|95.0|0.949|1.148|||Regression, Cox|||||1.148|0.949|0.3784
71116830|NCT01126437|141740282|SUPERIORITY_OR_OTHER||Rate ratio of events|1.09|STANDARD_ERROR_OF_MEAN|0.06||0.1255|TWO_SIDED|95.0|0.98|1.22||p-value from negative binomial regression.|Negative binomial regression|||||1.22|0.98|0.1255
70853689|NCT00759564|141195501|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|209.31|||||TWO_SIDED|90.0|158.81|275.87||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||275.87|158.81|
70853690|NCT00759564|141195501|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|353.0|||||TWO_SIDED|90.0|267.83|465.25||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||465.25|267.83|
70853691|NCT00759564|141195501|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|742.68|||||TWO_SIDED|90.0|529.59|1041.5||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||1041.50|529.59|
70941023|NCT02592434|141381834|SUPERIORITY||LS mean difference|5.47|STANDARD_ERROR_OF_MEAN|4.76||0.2539|TWO_SIDED|95.0|-4.01|14.95|||MMRM|||Social Limitations: Emotional: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||14.95|-4.01|0.2539
71116831|NCT01126437|141740282|SUPERIORITY_OR_OTHER||Rate ratio of events|1.06|STANDARD_ERROR_OF_MEAN|0.06||0.3441|TWO_SIDED|95.0|0.94|1.18||p-value from negative binomial regression.|Negative binomial regression|||||1.18|0.94|0.3441
71116832|NCT01126437|141740282|SUPERIORITY_OR_OTHER||Rate ratio of events|1.03|STANDARD_ERROR_OF_MEAN|0.06||0.5573|TWO_SIDED|95.0|0.92|1.16||p-value from negative binomial regression.|Negative binomial regression|||||1.16|0.92|0.5573
71116833|NCT01126437|141740283|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.011||||0.6823|TWO_SIDED|95.0|0.959|1.066|||Regression, Cox|||||1.066|0.959|0.6823
71116834|NCT01126437|141740283|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.983||||0.5377|TWO_SIDED|95.0|0.932|1.037|||Regression, Cox|||||1.037|0.932|0.5377
71116835|NCT01126437|141740283|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.028||||0.3048|TWO_SIDED|95.0|0.975|1.084|||Regression, Cox|||||1.084|0.975|0.3048
71116836|NCT01126437|141740284|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.105||||0.3043|TWO_SIDED|95.0|0.913|1.336|||Regression, Cox|||Causes of death from MACE were determined by adjudication.||1.336|0.913|0.3043
71116837|NCT01126437|141740284|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.3263|TWO_SIDED|95.0|0.909|1.331|||Regression, Cox|||Causes of death from MACE were determined by adjudication.||1.331|0.909|0.3263
71116838|NCT01126437|141740284|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.004||||0.9644|TWO_SIDED|95.0|0.834|1.209|||Regression, Cox|||Causes of death from MACE were determined by adjudication.||1.209|0.834|0.9644
71116839|NCT01126437|141740285|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.171||||0.2439|TWO_SIDED|95.0|0.898|1.526|||Regression, Cox|||Time to death from MACE was analyzed using the full study duration including vital status follow-up.||1.526|0.898|0.2439
71116840|NCT01126437|141740285|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.111||||0.4413|TWO_SIDED|95.0|0.85|1.453|||Regression, Cox|||Time to death from MACE was analyzed using the full study duration including vital status follow-up.||1.453|0.850|0.4413
70941024|NCT02592434|141381834|SUPERIORITY||LS mean difference|7.22|STANDARD_ERROR_OF_MEAN|5.56||0.1981|TWO_SIDED|95.0|-3.86|18.3|||MMRM|||Social Limitations: Physical Subscale: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||18.30|-3.86|0.1981
71116841|NCT01126437|141740285|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.054||||0.691|TWO_SIDED|95.0|0.814|1.363|||Regression, Cox|||Time to death from MACE was analyzed using the full study duration including vital status follow-up.||1.363|0.814|0.6910
71116842|NCT01220973|141740294|OTHER||Slope|0.74|||||TWO_SIDED|||||||||||||
71116843|NCT03525600|141740311|SUPERIORITY||LS Mean Difference|-0.2296||||0.0615|TWO_SIDED|95.0|-0.4703|0.0111|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + presence of choroidal neovascularization (CNV) in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area × analysis visit.||0.0111|-0.4703|0.0615
71116844|NCT03525600|141740311|SUPERIORITY||LS Mean Difference|-0.2077||||0.0854|TWO_SIDED|95.0|-0.4444|0.029|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area × analysis visit.||0.0290|-0.4444|0.0854
71116845|NCT03525600|141740312|SUPERIORITY||LS Mean Difference|-0.7451||||0.0004|TWO_SIDED|95.0|-1.1539|-0.3362|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + baseline presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) × analysis visit.||-0.3362|-1.1539|0.0004
71116846|NCT03525600|141740312|SUPERIORITY||LS Mean Difference|-0.6331||||0.003|TWO_SIDED|95.0|-1.0508|-0.2153|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + baseline presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) × analysis visit.||-0.2153|-1.0508|0.0030
71116847|NCT03525600|141740313|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.0547||||0.4282|TWO_SIDED|95.0|-0.1899|0.0806|||MMRM model|||Estimates for Baseline to Month 6: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||0.0806|-0.1899|0.4282
71116848|NCT03525600|141740313|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.0793||||0.2457|TWO_SIDED|95.0|-0.2131|0.0546|||MMRM model|||Estimates for Baseline to Month 6: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||0.0546|-0.2131|0.2457
71116849|NCT03525600|141740313|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.1722||||0.0292|TWO_SIDED|95.0|-0.327|-0.0174|||MMRM model|||Estimates for Month 6 to Month 12: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0174|-0.3270|0.0292
71116850|NCT03525600|141740313|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.1659||||0.0352|TWO_SIDED|95.0|-0.3202|-0.0115|||MMRM model|||Estimates for Month 6 to Month 12: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0115|-0.3202|0.0352
71116851|NCT03525600|141740313|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.145||||0.0514|TWO_SIDED|95.0|-0.2909|0.0009|||MMRM model|||Estimates for Month 12 to Month 18: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||0.0009|-0.2909|0.0514
71116852|NCT03525600|141740313|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.168||||0.0265|TWO_SIDED|95.0|-0.3164|-0.0196|||MMRM model|||Estimates for Month 12 to Month 18: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0196|-0.3164|0.0265
71117730|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-53.21|||<|0.001|TWO_SIDED|95.0|-70.16|-36.26||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-36.26|-70.16|<0.001
70853692|NCT00759564|141195502|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|209.55|||||TWO_SIDED|90.0|158.72|276.66||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||276.66|158.72|
70853693|NCT00759564|141195502|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|353.26|||||TWO_SIDED|90.0|267.57|466.39||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||466.39|267.57|
70941025|NCT02592434|141381834|SUPERIORITY||LS mean difference|8.26|STANDARD_ERROR_OF_MEAN|4.36||0.062|TWO_SIDED|95.0|-0.43|16.94|||MMRM|||Bodily Pain: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||16.94|-0.43|0.0620
71076441|NCT02051335|141661601|SUPERIORITY_OR_OTHER||LS mean difference|2.01|STANDARD_ERROR_OF_MEAN|0.972||0.042|TWO_SIDED|95.0|0.1|4.0||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||4.0|0.1|0.042
71076442|NCT02051335|141661601|SUPERIORITY_OR_OTHER||LS mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.974||0.928|TWO_SIDED|95.0|-1.9|2.0||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||2.0|-1.9|0.928
71076443|NCT02051335|141661601|SUPERIORITY_OR_OTHER||LS mean difference|2.86|STANDARD_ERROR_OF_MEAN|0.943||0.004|TWO_SIDED|95.0|1.0|4.7||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||4.7|1.0|0.004
71076444|NCT00187278|141661611|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.926||||0.3492|TWO_SIDED|95.0|0.789|1.0088||adjusted p|Regression, Cox|||||1.0088|0.789|0.3492
71076445|NCT00187278|141661612|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.878||||0.0882|TWO_SIDED|95.0|0.756|1.02||adjusted p|Regression, Cox|||||1.020|0.756|0.0882
71076446|NCT00187278|141661613|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.8215|TWO_SIDED|95.0|0.74|1.27|||Regression, Cox|||||1.27|0.74|0.8215
71076447|NCT00803205|141661628|SUPERIORITY|||||||0.3264|||||||ANOVA|||||||0.3264
71076448|NCT00803205|141661629|SUPERIORITY||Mean Difference (Final Values)|2.754|STANDARD_ERROR_OF_MEAN|1.78124||0.1235|TWO_SIDED|95.0|-0.756|6.264||The p-value is the LS-mean for the comparison between active treatment and placebo. The level of significance was 0.04998.|Mixed Models Analysis|||Least squares (LS) mean estimates based on mixed model for repeated measures (Weeks 8, 16, 24, 32, 40 and 48) of relative change in percent-predicted FEV1 as the dependent variable; independent variables including Baseline percent-predicted FEV1, treatment, visit, interactions between treatment and visit and between Baseline percent-predicted FEV1 and visit; and stratification factors of Baseline age, Baseline inhaled antibiotics, and Baseline percent-predicted FEV1.||6.2640|-0.7560|0.1235
71076449|NCT00379808|141661652|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.22|||||||Wilcoxon sign rank test|||Statistical power was calculated using G\*Power (Dusseldorf, Germany). Based on previously observed effects of statin drugs on hsCRP levels, 22 subjects provided 80% power to detect a moderate effect on hsCRP levels.||||0.22
71076450|NCT00379808|141661653|SUPERIORITY_OR_OTHER||percent difference|3.8||||0.57|||||||Wilcoxon sign rank|||Null hypothesis is that montelukast does not affect HDL. Not powered for this endpoint||||0.57
71076451|NCT00379808|141661654|SUPERIORITY_OR_OTHER||percent difference|7.4||||0.33|||||||wilcoxon sign rank|||The null hypothesis is that montelukast does not affect triglycerides. The study was not powered to this outcome measure.||||0.33
71076452|NCT00379808|141661655|SUPERIORITY_OR_OTHER||percent difference|11.9||||0.12|||||||Wilcoxon|||null hypothesis is that montelukast does not affect MCP-1. Study not powered to the biomarker.||||0.12
71076453|NCT00379808|141661656|SUPERIORITY_OR_OTHER||percent difference|13.3||||0.03|||||||wilcoxon sign rank test|||null hypothesis is that montelukast does not affect IL1ra.||||0.03
70941026|NCT02592434|141381834|SUPERIORITY||LS mean difference|-3.43|STANDARD_ERROR_OF_MEAN|2.83||0.2291|TWO_SIDED|95.0|-9.06|2.2|||MMRM|||Behavior: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||2.20|-9.06|0.2291
71076454|NCT00379808|141661657|SUPERIORITY_OR_OTHER||percent difference|16.5||||0.09|||||||wilcoxon sign rank|||null hypothesis is that montelukast does not affect ENA-78. The study is not powered to this biomarker||||0.09
71076455|NCT01432561|141661658|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||High-fat/calorie compared to fasted condition||||.04
71076456|NCT01432561|141661658|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANOVA|||High-protein compared to fasted condition||||.005
71076457|NCT01432561|141661659|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||High-fat/calorie compared to fasted condition||||.16
71076458|NCT01432561|141661659|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||ANOVA|||High-protein compared to fasted condition||||.036
71076459|NCT01432561|141661660|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Non-parametric Hodges-Lehmann method|||Fed high-fat/calorie compared to fasted condition.||||.30
71076460|NCT01432561|141661660|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Non-parametric Hodges-Lehmann method|||High-protein compared to fasted condition||||.05
71079460|NCT00482170|141666445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.098|TWO_SIDED|95.0|0.94|2.03||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.03|0.94|0.098
70853694|NCT00759564|141195502|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|735.77|||||TWO_SIDED|90.0|523.56|1034.0||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||1034.00|523.56|
71116853|NCT03525600|141740313|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.3532|||<|0.0001|TWO_SIDED|95.0|-0.5245|-0.1819|||MMRM model|||Estimates for Month 18 to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.1819|-0.5245|<0.0001
71116854|NCT03525600|141740313|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.2848||||0.0002|TWO_SIDED|95.0|-0.4336|-0.1361|||MMRM model|||Estimates for Month 18 to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.1361|-0.4336|0.0002
71116855|NCT03525600|141740313|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.7251||||0.0006|TWO_SIDED|95.0|-1.1373|-0.3129|||MMRM model|||Estimates for Baseline to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.3129|-1.1373|0.0006
71116856|NCT03525600|141740313|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.698||||0.001|TWO_SIDED|95.0|-1.1142|-0.2817|||MMRM model|||Estimates for Baseline to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.2817|-1.1142|0.0010
71116857|NCT01191736|141740317|SUPERIORITY_OR_OTHER|||||||0.05|||||||Kruskal-Wallis|Null hypothesis: the medians for all seven arms are equal.||Kruskal-Wallis test for multiple comparisons||||.05
71116858|NCT01191736|141740318|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0|||||Chi-squared|Null hypothesis: the proportions within the seven arms are equal.||Comparison of proportions of subjects who assessed responsiveness||||.05
71116859|NCT03703817|141740319|SUPERIORITY|Effectiveness: Multivariate analysis was used to control and remove the possible influence of the independent variables (demographic and clinical characteristics).||||||0.3648|||||||Linear mixed model|||||||0.3648
71116860|NCT03703817|141740319|SUPERIORITY|Side effect: Multivariate analysis was used to control and remove the possible influence of the independent variables (demographic and clinical characteristics).||||||0.1395|||||||Conditional logistic regression|||||||0.1395
71116861|NCT03703817|141740319|SUPERIORITY|Convenience: Multivariate analysis was used to control and remove the possible influence of the independent variables (demographic and clinical characteristics).||||||0.0349|||||||Linear mixed model|||||||0.0349
71116862|NCT03703817|141740319|SUPERIORITY|Global satisfaction: Multivariate analysis was used to control and remove the possible influence of the independent variables (demographic and clinical characteristics).||||||0.1546|||||||Linear mixed model|||||||0.1546
71116863|NCT03703817|141740320|SUPERIORITY|Multivariate analysis was used to control and remove the possible influence of the independent variables (demographic and clinical characteristics).||||||0.1602|||||||Conditional logistic regression model|||||||0.1602
71116864|NCT03703817|141740321|SUPERIORITY|Multivariate analysis was used to control and remove the possible influence of the independent variables (demographic and clinical characteristics).||||||0.9921|||||||Linear mixed model|||||||0.9921
71116865|NCT02438384|141740377|SUPERIORITY||Mean Difference (Final Values)|1.7|||||TWO_SIDED|95.0|1.2|2.1||||||||2.1|1.2|
71116866|NCT02438384|141740377|SUPERIORITY||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|0.6|1.6||||||||1.6|0.6|
71116867|NCT03319953|141740381|SUPERIORITY|||||||0.2079||||||Bayesian method was used to calculate the posterior probability. High posterior probability of a difference between TAK-041 and placebo \>2.0.|Bayesian Normal Linear Model|||||||0.2079
71116868|NCT03319953|141740381|SUPERIORITY|||||||0.0633||||||Bayesian method was used to calculate the posterior probability. High posterior probability of a difference between TAK-041 and placebo \>2.0.|Bayesian Normal Linear Model|||||||0.0633
71116869|NCT03319953|141740382|SUPERIORITY|||||||0.1706||||||Bayesian method was used to calculate the posterior probability. High posterior probability of a difference between TAK-041 and placebo \>0.09.|Bayesian Normal Linear Model|||||||0.1706
71116870|NCT03319953|141740382|SUPERIORITY|||||||0.0373||||||Bayesian method was used to calculate the posterior probability. High posterior probability of a difference between TAK-041 and placebo \>0.09.|Bayesian Normal Linear Model|||||||0.0373
70941027|NCT02592434|141381834|SUPERIORITY||LS mean difference|-3.65|STANDARD_ERROR_OF_MEAN|3.9||0.353|TWO_SIDED|95.0|-11.43|4.13|||MMRM|||Global Behavior: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||4.13|-11.43|0.3530
71076461|NCT02638259|141661672|EQUIVALENCE|A margin of 0.6 can be statistically and clinically justified based on the results Keystone et al, Arthritis and Rheumatism, p353-363, (2004) and on the EULAR response criteria. The sample size of 155 per group with 90% power is based on the common SD of 1.46 and was calculated using nQuery 7.0.|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.097|||TWO_SIDED|95.0|-0.26|0.12||||||Therapeutic equivalence in terms of change from baseline in DAS28-CRP at week 24 will be concluded if the 95% confidence interval for the LS mean difference between GP2015 and Enbrel is contained within the interval \[-0.6; 0.6\]. A mixed-model repeated measures analysis was performed for DAS28-CRP change from baseline including treatment, stratification factors, time, the interaction between time (visits) and treatment all as categorical variables, and baseline DAS28-CRP as a continuous variable.||0.12|-0.26|
71076462|NCT02952872|141661721|SUPERIORITY||||||<|0.05|||||||ANOVA|Mixed Design ANOVA||||||<.05
71076463|NCT02952872|141661722|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
71076464|NCT02952872|141661723|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
71076465|NCT02952872|141661724|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
71076466|NCT02069093|141661735|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Incidence rate R|||A test of the incidence rate R was performed with null hypothesis H0: R\>= 0.33 and alternative hypothesis Ha: R\<0.33 with a one-sided significance level of 0.05. If the test statistic was negative (actual incidence rate was \<0.33), the one-sided p-value for the null hypothesis R\>=0.33 was presented. The null hypothesis was rejected if the statistic was negative and the corresponding p-value for the one-sided test was \<0.5.||||<0.001
71076467|NCT02028169|141661741|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
71076468|NCT02028169|141661742|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
71116871|NCT03315793|141740388|SUPERIORITY||Least squares mean difference|1.39||||0.5587|TWO_SIDED|98.0|-3.3|6.08|||mixed-effects model repeated measures|||||6.08|-3.30|0.5587
71116872|NCT03315793|141740389|SUPERIORITY||Risk Difference (RD)|5.4||||0.5111|TWO_SIDED|95.0|-10.7|21.5|||Cochran-Mantel-Haenszel|Stratified by age||||21.5|-10.7|0.5111
71076469|NCT02028169|141661743|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline Vs. Month 9||||< 0.001
71076470|NCT02028169|141661744|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
71076471|NCT02028169|141661745|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
71076472|NCT02028169|141661745|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
71076473|NCT02028169|141661745|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
71076474|NCT02028169|141661748|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
71116873|NCT03315793|141740390|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-13.5|13.5|||Cochran-Mantel-Haenszel|Stratified by age||||13.5|-13.5|1.0000
71116874|NCT03315793|141740391|SUPERIORITY||Risk Difference (RD)|-4.1||||0.4423|TWO_SIDED|95.0|-14.4|6.3|||Cochran-Mantel-Haenszel|Stratified by age||||6.3|-14.4|0.4423
71116875|NCT03315793|141740392|SUPERIORITY||Least squares mean difference|0.14||||0.3836|TWO_SIDED|95.0|-0.18|0.46|||mixed-effects model repeated measures|||||0.46|-0.18|0.3836
71076475|NCT02028169|141661748|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
71076476|NCT02028169|141661748|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
71076477|NCT02028169|141661749|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
71076478|NCT02028169|141661749|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
71076479|NCT02028169|141661749|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
71076480|NCT02028169|141661750|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
71076481|NCT02028169|141661751|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
71076482|NCT02028169|141661751|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
71076483|NCT02028169|141661751|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
71076484|NCT02028169|141661753|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
71076485|NCT02028169|141661755|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
71076486|NCT02028169|141661755|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
71076487|NCT02028169|141661755|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
71076488|NCT02028169|141661756|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
71076489|NCT02028169|141661756|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
71076490|NCT02028169|141661756|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
71076491|NCT02028169|141661757|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
71076492|NCT02028169|141661757|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
71076493|NCT02028169|141661757|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
71076494|NCT02028169|141661758|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
71076495|NCT02028169|141661758|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
71076496|NCT02028169|141661758|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
71076497|NCT02028169|141661759|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
71076498|NCT02028169|141661759|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
71076499|NCT02028169|141661759|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
71076500|NCT00862459|141661766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59|STANDARD_DEVIATION|1.49||0.003|||||||t-test, 2 sided|||2 sample t-test between the dose groups||||0.003
71076501|NCT00862459|141661766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|1.59||0.844|||||||t-test, 2 sided|||||||0.844
71076502|NCT00862459|141661767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.069|STANDARD_DEVIATION|2.92||||95.0|-0.825|0.69|||confidence interval using t-distribution|||||0.69|-0.825|
71076503|NCT00862459|141661767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_DEVIATION|3.18||||95.0|-0.9|0.79|||confidence interval using t-distribution|||||0.79|-0.90|
71076504|NCT00862459|141661768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_DEVIATION|1.42||||95.0|-1.17|-0.42|||confidence interval using t-distribution|||||-0.42|-1.17|
71076505|NCT00862459|141661768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|1.57||||95.0|-0.44|0.41|||confidence interval using t-distribution|||||0.41|-0.44|
71076506|NCT00862459|141661769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|0.86||||95.0|-0.619|-0.17|||confidence interval using t-distribution|||||-0.17|-0.619|
71076507|NCT00862459|141661769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|1.01||||95.0|-0.25|0.22|||confidence interval using t-distribution|||||0.22|-0.25|
71076508|NCT00862459|141661770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_DEVIATION|0.76||||95.0|-0.58|-0.18|||confidence interval using t-distribution|||||-0.18|-0.58|
71076509|NCT00862459|141661770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|0.76||||95.0|-0.1|0.31|||confidence interval using t-distribution|||||0.31|-0.10|
71076510|NCT00862459|141661771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.54|STANDARD_DEVIATION|76.45||||95.0|-37.11|2.02|||confidence interval using t-distribution|||difference in CNR between doses and confidence interval||2.02|-37.11|
71076511|NCT00862459|141661771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.74|STANDARD_DEVIATION|77.11||||95.0|-15.86|25.35|||confidence interval using t-distribution|||||25.35|-15.86|
71076512|NCT00862459|141661772|SUPERIORITY_OR_OTHER||accuracy difference|1.66|STANDARD_ERROR_OF_MEAN|6.29||0.8||95.0|-10.93|14.24|||Chi-squared|Adjusted for clustering||||14.24|-10.93|0.80
71076513|NCT00862459|141661772|SUPERIORITY_OR_OTHER||difference in accuracies|-10.75|STANDARD_ERROR_OF_MEAN|6.83||0.13||95.0|-24.41|2.9|||Chi-squared|adjusted for clustering||||2.90|-24.41|0.13
71076514|NCT00862459|141661773|SUPERIORITY_OR_OTHER||difference in accuracy|13.43||||0.03||95.0|1.53|25.33|||Chi-squared|adjusted for clustering||||25.33|1.53|0.03
71076515|NCT00862459|141661773|SUPERIORITY_OR_OTHER||difference in accuracies|-13.58||||0.02||95.0|-25.07|-2.09|||Chi-squared|adjusted for clustering||||-2.09|-25.07|0.02
71076516|NCT00862459|141661774|SUPERIORITY_OR_OTHER||difference in accuracy|-6.13||||0.11||95.0|-13.73|1.48|||Chi-squared|adjusted for clustering||||1.48|-13.73|0.11
71076517|NCT00862459|141661774|SUPERIORITY_OR_OTHER||difference in accuracies|2.87||||0.55||95.0|-6.59|12.32|||Chi-squared|adjusted for clustering||||12.32|-6.59|0.55
71076518|NCT00862459|141661775|SUPERIORITY_OR_OTHER||difference in accuracy|24.63||||0.02||95.0|5.39|43.86|||Chi-squared|adjusted for clustering||||43.86|5.39|0.02
71076519|NCT00862459|141661775|SUPERIORITY_OR_OTHER||difference in accuracy|-10.75||||0.13||95.0|-24.41|2.9|||Chi-squared|adjusted for clustering||||2.90|-24.41|0.13
71076520|NCT00862459|141661776|SUPERIORITY_OR_OTHER||difference in accuracy|12.91||||0.07||95.0|-1.44|27.26|||Chi-squared|adjusted for clustering||||27.26|-1.44|0.07
71076521|NCT00862459|141661776|SUPERIORITY_OR_OTHER||difference in accuracy|-18.37||||0.02||95.0|-33.6|-1.35|||Chi-squared|adjusted for clustering||||-1.35|-33.60|0.02
71076522|NCT00862459|141661777|SUPERIORITY_OR_OTHER||difference in accuracy|18.46||||0.02||95.0|3.15|33.77|||Chi-squared|adjusted for clustering||||33.77|3.15|0.02
71076523|NCT00862459|141661777|SUPERIORITY_OR_OTHER||difference in accuracy|-5.29||||0.45||95.0|-18.83|8.24|||Chi-squared|adjusted for clustering||||8.24|-18.83|0.45
71076524|NCT04907227|141661826|OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.32|2.46|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||2.46|0.32|
71076525|NCT04907227|141661827|OTHER||Hazard Ratio (HR)|1.59|||||TWO_SIDED|95.0|0.68|3.67|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||3.67|0.68|
71076526|NCT04907227|141661828|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.45|1.5|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.50|0.45|
71076527|NCT04907227|141661830|OTHER||Percent Difference|4.3|||||TWO_SIDED|95.0|-24.1|31.2|||||Based on Miettinen \& Nurminen method.|||31.2|-24.1|
71076528|NCT04907227|141661832|OTHER||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.17|1.99|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.99|0.17|
71076529|NCT04907227|141661833|OTHER||Hazard Ratio (HR)|1.64|||||TWO_SIDED|95.0|0.15|18.24|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||18.24|0.15|
71076530|NCT04907227|141661834|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.41|1.46|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.46|0.41|
71076531|NCT04907227|141661835|OTHER||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.43|3.17|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||3.17|0.43|
71076532|NCT02240069|141661838|SUPERIORITY||Mean Difference (Net)|-0.11||||0.1|TWO_SIDED|95.0|-0.24|0.02|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in FEV1 for Education group relative to Placebo group||0.02|-0.24|0.10
71076533|NCT02240069|141661838|SUPERIORITY||Mean Difference (Net)|0.01||||0.9|TWO_SIDED|95.0|-0.11|0.13|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in FEV1 for Filtration group relative to Placebo group||0.13|-0.11|0.90
71076534|NCT02240069|141661839|SUPERIORITY||Mean Difference (Net)|-0.09||||0.28|TWO_SIDED|95.0|-0.24|0.07|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in FVC for Education group relative to Placebo group||0.07|-0.24|0.28
70853695|NCT02788279|141195530|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9871|TWO_SIDED|95.0|0.73|1.38|||Stratified Log-Rank|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|Hazard ratio was estimated using stratified Cox regression.|||1.38|0.73|0.9871
71076535|NCT02240069|141661839|SUPERIORITY||Mean Difference (Net)|0.01||||0.89|TWO_SIDED|95.0|-0.14|0.16|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in FVC for Filter group relative to Placebo group||0.16|-0.14|0.89
71076536|NCT02240069|141661840|SUPERIORITY||Mean Difference (Net)|-0.02||||0.06|TWO_SIDED|95.0|-0.05|0.0|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in FEV1/FVC for Education group relative to Placebo group||0.00|-0.05|0.06
71076537|NCT02240069|141661840|SUPERIORITY||Mean Difference (Net)|0.0||||0.71|TWO_SIDED|95.0|-0.03|0.02|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in FEV1/FVC for Filter group relative to Placebo group||0.02|-0.03|0.71
71076538|NCT02240069|141661841|SUPERIORITY||Mean Difference (Net)|-3.46||||0.39|TWO_SIDED|95.0|-11.45|4.54|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in systolic blood pressure for Education group relative to Placebo group||4.54|-11.45|0.39
71076539|NCT02240069|141661841|SUPERIORITY||Mean Difference (Net)|0.25||||0.95|TWO_SIDED|95.0|-7.73|8.24|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in systolic blood pressure for Filter group relative to Placebo group||8.24|-7.73|0.95
71076540|NCT02240069|141661842|SUPERIORITY||Mean Difference (Net)|-1.0||||0.65|TWO_SIDED|95.0|-5.42|3.42|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in diastolic blood pressure for Education group relative to Placebo group||3.42|-5.42|0.65
71076541|NCT02240069|141661842|SUPERIORITY||Mean Difference (Net)|-0.58||||0.79|TWO_SIDED|95.0|-4.97|3.81|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in diastolic blood pressure for Filter group relative to Placebo group||3.81|-4.97|0.79
70853696|NCT02788279|141195530|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.336|TWO_SIDED|95.0|0.83|1.71|||Stratified Log-Rank|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|Hazard ratio was estimated using stratified Cox regression.|||1.71|0.83|0.3360
70853697|NCT02788279|141195530|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9686|TWO_SIDED|95.0|0.74|1.38|||Unstratified Log-Rank||Hazard ratio was estimated using unstratified Cox regression.|||1.38|0.74|0.9686
70853698|NCT02788279|141195530|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.3553|TWO_SIDED|95.0|0.83|1.69|||Unstratified Log-Rank||Hazard ratio was estimated using unstratified Cox regression.|||1.69|0.83|0.3553
70853699|NCT02788279|141195531|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.1208|TWO_SIDED|95.0|0.94|1.65|||Stratified Log-Rank|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|Hazard ratio was estimated using stratified Cox regression.|||1.65|0.94|0.1208
70941028|NCT02592434|141381834|SUPERIORITY||LS mean difference|-3.47|STANDARD_ERROR_OF_MEAN|3.41||0.3114|TWO_SIDED|95.0|-10.26|3.32|||MMRM|||Mental Health: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||3.32|-10.26|0.3114
71076542|NCT02240069|141661843|SUPERIORITY||Mean Difference (Net)|-2.9||||0.88|TWO_SIDED|95.0|-33.6|42.0|||Mixed Models Analysis|Linear mixed models adjusted for pre-intervention PM2.5. The model includes a nested random term to account for repeated measures.||Pre- to post-intervention change in indoor PM2.5 concentration for Education group relative to Placebo group||42.0|-33.6|0.88
71076543|NCT02240069|141661843|SUPERIORITY||Mean Difference (Net)|-50.5|||<|0.001|TWO_SIDED|95.0|-66.1|-27.8|||Mixed Models Analysis|Linear mixed models adjusted for pre-intervention PM2.5. The model includes a nested random term to account for repeated measures.||Pre- to post-intervention change in indoor PM2.5 concentration for Filter group relative to Placebo group||-27.8|-66.1|<0.001
71076544|NCT00824434|141661860|SUPERIORITY_OR_OTHER||Mean In-stent Late Loss in WH Lesions|0.17|||<|0.0001|ONE_SIDED|95.0||0.22|||t-test, 1 sided|||The Student t-test was used to compare the outcome to a prespecified performance goal of 0.44 mm based on an historical TAXUS Express workhorse 9-month in-stent late loss (0.41 mm) value plus delta (0.03 mm)||0.22||<0.0001
71076545|NCT00824434|141661861|SUPERIORITY_OR_OTHER||Percent Post-procedure Incomplete Apposi|5.7|||<|0.0001|ONE_SIDED|95.0||11.6|||One-sided exact binomial test|||A one-sided 95% Clopper-Pearson upper confidence bound was derived and tested to determine if the outcome was less than a prespecified performance goal based on historical XIENCE V/PROMUS post-procedure incomplete apposition data from the SPIRIT III study (34.4%).||11.6||<0.0001
71116876|NCT01331837|141740393|NON_INFERIORITY_OR_EQUIVALENCE|In order to reject the null hypothesis and claim non-inferiority of TCZ compared to ETA, a HR point estimate of ≤ 1.278 and upper limit of 95% CI \<1.8 was required.|Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.77|1.43||||||"The analysis assessed in the ITT population the hazard ratio of the primary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.43|0.77|
71116877|NCT01331837|141740395|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis'|Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.76|1.62||||||"The analysis assessed in the OT population the hazard ratio of the primary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.62|0.76|
71116878|NCT01331837|141740397|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis and not for the sensitivity analysis.|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.73|1.4||||||"The analysis assessed in the ITT population the hazard ratio of the primary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.40|0.73|
71116879|NCT01331837|141740399|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis and not for the sensitivity analysis.|Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.7|1.56||||||"The analysis assessed in the ITT population the hazard ratio of the primary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.56|0.70|
71116880|NCT01331837|141740401|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis.|Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.73|1.34||||||"The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.34|0.73|
71116881|NCT01331837|141740403|NON_INFERIORITY_OR_EQUIVALENCE|'The non-inferiority margin was only formally tested for the primary ITT analysis'|Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.54|1.49||||||"The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.49|0.54|
70941029|NCT02592434|141381834|SUPERIORITY||LS mean difference|0.71|STANDARD_ERROR_OF_MEAN|4.46||0.8736|TWO_SIDED|95.0|-8.18|9.61|||MMRM|||Self Esteem: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||9.61|-8.18|0.8736
71076546|NCT02134353|141661875|SUPERIORITY||Mean Difference (Net)|54.0||||0.02|TWO_SIDED|95.0|8.0|100.0|||Mixed Models Analysis||Missing data for withdrawals related to safety or efficacy imputed using BOCF (baseline observation carried forward). Data collected at 6, 14 and 26 weeks.|||100|8|0.020
70941030|NCT02592434|141381834|SUPERIORITY||LS mean difference|1.77|STANDARD_ERROR_OF_MEAN|2.48||0.4778|TWO_SIDED|95.0|-3.18|6.72|||MMRM|||General Health Subscale: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||6.72|-3.18|0.4778
70941031|NCT02592434|141381834|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.13||0.8909|TWO_SIDED|95.0|-0.28|0.25|||MMRM|||Change in Health: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||0.25|-0.28|0.8909
71116882|NCT01331837|141740405|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis.|Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.64|1.63||||||"The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.63|0.64|
71116883|NCT01331837|141740407|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis.|Hazard Ratio (HR)|1.53|||||TWO_SIDED|95.0|0.8|2.92||||||"The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||2.92|0.80|
71116884|NCT01331837|141740409|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis.|Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.7|1.41||||||"The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.41|0.70|
71117731|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-47.82|||<|0.001|TWO_SIDED|95.0|-64.81|-30.83||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-30.83|-64.81|<0.001
71117732|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-3.52||||0.604|TWO_SIDED|95.0|-16.89|9.85||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.85|-16.89|0.604
71117733|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-8.78||||0.184|TWO_SIDED|95.0|-21.5|3.94||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.94|-21.50|0.184
71117734|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-6.43||||0.34|TWO_SIDED|95.0|-19.56|6.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||6.70|-19.56|0.340
71117735|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-40.27|||<|0.001|TWO_SIDED|95.0|-57.67|-22.88||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-22.88|-57.67|<0.001
71117736|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-47.24|||<|0.001|TWO_SIDED|95.0|-64.21|-30.27||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-30.27|-64.21|<0.001
71117737|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-43.15|||<|0.001|TWO_SIDED|95.0|-60.57|-25.72||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-25.72|-60.57|<0.001
71117738|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-44.45|||<|0.001|TWO_SIDED|95.0|-61.55|-27.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-27.34|-61.55|<0.001
70941032|NCT02592434|141381834|SUPERIORITY||LS mean difference|8.97|STANDARD_ERROR_OF_MEAN|5.81||0.127|TWO_SIDED|95.0|-2.61|20.55|||MMRM|||Emotional Impact on Parent: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||20.55|-2.61|0.1270
70941033|NCT02592434|141381834|SUPERIORITY||LS mean difference|-6.72|STANDARD_ERROR_OF_MEAN|3.96||0.0944|TWO_SIDED|95.0|-14.62|1.18|||MMRM|||Time Impact on Parent: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||1.18|-14.62|0.0944
70941034|NCT02592434|141381834|SUPERIORITY||LS mean difference|-8.6|STANDARD_ERROR_OF_MEAN|3.23||0.0095|TWO_SIDED|95.0|-15.03|-2.17|||MMRM|||Family Activities: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-2.17|-15.03|0.0095
71116885|NCT01380535|141740468|OTHER|||||||0.373|||||||Fisher Exact|||||||0.373
71116886|NCT02791191|141740477|SUPERIORITY|||||||0.418|||||||ANCOVA|||||||0.418
71116887|NCT02791191|141740477|SUPERIORITY|||||||0.231|||||||ANCOVA|||||||0.231
71116888|NCT02791191|141740478|SUPERIORITY|||||||1|||||||Fisher Exact|||White Matter Disease||||1.000
71116889|NCT02791191|141740478|SUPERIORITY|||||||1|||||||Fisher Exact|||White Matter Disease||||1.000
71116890|NCT02791191|141740478|SUPERIORITY|||||||0.404|||||||Fisher Exact|||||||0.404
71116891|NCT02791191|141740478|SUPERIORITY|||||||1|||||||Fisher Exact|||Cortical Superficial Siderous||||1.000
71116892|NCT02791191|141740478|SUPERIORITY|Lacunar Infarct||||||1|||||||Fisher Exact|||||||1.000
71116893|NCT02791191|141740478|SUPERIORITY|||||||0.457|||||||Fisher Exact|||Lacunar Infarct||||0.457
70941035|NCT02592434|141381834|SUPERIORITY||LS mean difference|2.59|STANDARD_ERROR_OF_MEAN|4.29||0.5474|TWO_SIDED|95.0|-5.96|11.14|||MMRM|||Family Cohesion: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||11.14|-5.96|0.5474
70941036|NCT02592434|141381834|SUPERIORITY||LS mean difference|3.48|STANDARD_ERROR_OF_MEAN|2.03||0.0902|TWO_SIDED|95.0|-0.56|7.52|||MMRM|||Physical Health Summary: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||7.52|-0.56|0.0902
70941037|NCT02592434|141381834|SUPERIORITY||LS mean difference|-0.75|STANDARD_ERROR_OF_MEAN|1.67||0.6539|TWO_SIDED|95.0|-4.07|2.57|||MMRM|||Psychosocial Health Summary : Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||2.57|-4.07|0.6539
70941038|NCT02592434|141381836|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.24||0.1894|TWO_SIDED|95.0|-0.8|0.16|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.16|-0.80|0.1894
70941039|NCT02592434|141381836|SUPERIORITY||LS mean difference|-0.95|STANDARD_ERROR_OF_MEAN|0.31||0.0026|TWO_SIDED|95.0|-1.56|-0.34|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.34|-1.56|0.0026
71116894|NCT02791191|141740478|SUPERIORITY|||||||1|||||||Fisher Exact|||Other Infarct||||1.000
71116895|NCT02791191|141740478|SUPERIORITY|||||||0.457|||||||Fisher Exact|||Other Infarct||||0.457
71116896|NCT02791191|141740479|SUPERIORITY|||||||1|||||||Fisher Exact|||Vasogenic Edema||||1.000
71116897|NCT02791191|141740479|SUPERIORITY|||||||0.457|||||||Fisher Exact|||Vasogenic Edema||||0.457
71116898|NCT02791191|141740479|SUPERIORITY|||||||0.703|||||||Fisher Exact|||Increase in Microhemorrhage||||0.703
71116899|NCT02791191|141740479|SUPERIORITY|||||||1|||||||Fisher Exact|||Increase in Microhemorrhage||||1.000
71116900|NCT02791191|141740480|SUPERIORITY|||||||0.452|||||||Fisher Exact|||Treatment Emergent Suicidal Ideation||||0.452
71116901|NCT02791191|141740480|SUPERIORITY|||||||0.279||||||TE Suicidal Ideation|Fisher Exact|||||||0.279
71116902|NCT02791191|141740480|SUPERIORITY|||||||0.293|||||||Fisher Exact|||Emergence of Suicidal Behavior||||0.293
71116903|NCT02791191|141740480|SUPERIORITY|||||||0.486|||||||Fisher Exact|||Emergence of Suicidal Behavior||||0.486
71116904|NCT02791191|141740482|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Amyloid Beta||||<.001
71116905|NCT02791191|141740482|SUPERIORITY|Amyloid Beta|||||<|0.001|||||||ANCOVA|||||||<.001
71116906|NCT02791191|141740482|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Amyloid Beta 1-40||||<.001
71116907|NCT02791191|141740482|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Amyloid Beta 1-40||||<.001
71116908|NCT02791191|141740482|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Amyloid Beta 1-42||||<.001
71116909|NCT02791191|141740482|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Amyloid Beta 1-42||||<.001
71116910|NCT02791191|141740483|SUPERIORITY|||||||0.97|||||||Mixed Model Repeated Measures|||||||0.970
71116911|NCT02791191|141740483|SUPERIORITY|||||||0.586|||||||Mixed Model Repeated Meausres|||||||0.586
71116912|NCT02791191|141740484|SUPERIORITY|||||||0.088|||||||ANCOVA|||||||0.088
71116913|NCT02791191|141740484|SUPERIORITY|||||||0.15|||||||ANCOVA|||||||0.150
71116914|NCT02791191|141740485|SUPERIORITY|||||||0.153|||||||ANCOVA|||||||0.153
71116915|NCT02791191|141740485|SUPERIORITY|||||||0.176|||||||ANCOVA|||||||0.176
71116916|NCT01559259|141740576|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) Mean difference|26.28|||<|0.001|TWO_SIDED|95.0|20.33|32.22|||ANOVA|||Treatment difference and 95 percent (%) Confidence interval (CI) were based on Least square mean (LSM) from analysis of variance (ANOVA) with treatment, baseline categorical pain severity rating (PSR), gender and treatment-by-baseline categorical PSR terms used as covariates.||32.22|20.33|<0.001
71116917|NCT01559259|141740576|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|24.37|||<|0.001|TWO_SIDED|95.0|18.44|30.29|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||30.29|18.44|<0.001
71116918|NCT01559259|141740576|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|27.48|||<|0.001|TWO_SIDED|95.0|21.53|33.42|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||33.42|21.53|<0.001
71076547|NCT02134353|141661876|SUPERIORITY||Mean Difference (Net)|40.0||||0.128|TWO_SIDED|95.0|-12.0|92.0||Missing data for withdrawals due to safety/efficacy imputed using BOCF. Data collected at 6,14 and 26 weeks.|Mixed Models Analysis||Missing data for withdrawals related to safety or efficacy imputed using BOCF. Data collected at 6, 14 and 26 weeks.|||92|-12|0.128
71076548|NCT02134353|141661877|SUPERIORITY||Cox Proportional Hazard|1.14||||0.629|TWO_SIDED|95.0|0.671|1.936|||Regression, Cox|||||1.936|0.671|0.629
71076549|NCT02134353|141661878|SUPERIORITY||Rate ratio|0.75||||0.673|TWO_SIDED|95.0|0.198|2.846|||Negative binomial model|||||2.846|0.198|0.673
71076550|NCT02134353|141661879|SUPERIORITY||Rate ratio|1.273||||0.735|TWO_SIDED|95.0|0.315|5.154|||Negative binomial model|||||5.154|0.315|0.735
71076551|NCT02134353|141661880|SUPERIORITY||Rate ratio|1.545||||0.055|TWO_SIDED|95.0|0.99|2.411|||Negative binomial model|||Patients withdrawing early without an exacerbation had rate imputed based on number of exacerbations in 12 months prior to screening.||2.411|0.990|0.055
71076552|NCT02134353|141661880|SUPERIORITY||Rate ratio|1.357||||0.246|TWO_SIDED|95.0|0.81|2.275|||Negative binomial model|||Sensitivity analysis with no imputation of missing data.||2.275|0.810|0.246
71076553|NCT02134353|141661881|SUPERIORITY||Odds Ratio (OR)|1.009||||0.976|TWO_SIDED|95.0|0.555|1.836|||Regression, Logistic|||||1.836|0.555|0.976
71076554|NCT02134353|141661882|SUPERIORITY||Mean Difference (Net)|0.259||||0.083|TWO_SIDED|95.0|-0.034|0.551|||Mixed Models Analysis|Missing values due to withdrawal related to safety/efficacy imputed using BOCF||||0.551|-0.034|0.083
71076555|NCT02134353|141661883|SUPERIORITY||Mean Difference (Net)|0.87||||0.453|TWO_SIDED|95.0|-1.406|3.145|||Mixed Models Analysis||Missing values due to withdrawal related to safety/efficacy imputed using BOCF|||3.145|-1.406|0.453
71076556|NCT02134353|141661884|SUPERIORITY||Mean Difference (Net)|87.0||||0.012|TWO_SIDED|95.0|20.0|155.0|||Mixed Models Analysis||Missing data due to withdrawals for reasons related to safety/efficacy imputed using BOCF|||155|20|0.012
71076557|NCT00477607|141661885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0||||0.89|TWO_SIDED|95.0|0.4|11.4|||Fisher Exact|No adjustments. Right one-sided p-value.||H0: pr(Hearing loss arm 1) = pr(Hearing loss arm 2)||11.4|0.4|0.89
71076558|NCT00477607|141661886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.195|STANDARD_ERROR_OF_MEAN|0.3999||0.63|TWO_SIDED|95.0|-1.03|0.64|||t-test, 2 sided|||H0: mean (MDA arm 1) = mean (MDA Arm 2)||0.64|-1.03|0.63
71076559|NCT00477607|141661887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|48.2|STANDARD_ERROR_OF_MEAN|32.7||0.15|TWO_SIDED|95.0|-18.1|114.6|||t-test, 2 sided|||H0: mean(max dose arm 1) = mean(max dose arm 2)||114.6|-18.1|0.15
71076560|NCT00474786|141661888|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.87||||0.1933|TWO_SIDED|95.0|0.71|1.07||Stratified for nephrectomy status, duration of response to sunitinib therapy, tumor histology, and Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group.|Log Rank||Hazard ratio less than (\<) 1 means temsirolimus (TEMSR) is at lower risk.|||1.07|0.71|0.1933
71076561|NCT00474786|141661889|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.87||||0.1888|TWO_SIDED|95.0|0.7|1.07||Stratified for nephrectomy status, duration of response to sunitinib therapy, tumor histology, and Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group.|Log Rank||Hazard ratio less than (\<) 1 means temsirolimus (TEMSR) is at lower risk.|||1.07|0.70|0.1888
71076562|NCT00474786|141661891|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.31||||0.0144|TWO_SIDED|95.0|1.05|1.63||Stratified for nephrectomy status, duration of response to sunitinib therapy, tumor histology, and MSKCC prognostic group.|Log Rank||Hazard ratio \<1 means temsirolimus (TEMSR) is at lower risk.|||1.63|1.05|0.0144
71076563|NCT04942210|141661928|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) was \>-5%|Difference in percentage of participants|0.3|||||TWO_SIDED|95.0|-1.2|3.2|||||95% CI of the difference was calculated from the Wilson score method without continuity correction.|||3.2|-1.2|
71076564|NCT01410240|141661967|SUPERIORITY_OR_OTHER|||||||0.453|||||||one-sided, two-sample t-test|||||||0.453
71076565|NCT01410240|141661968|SUPERIORITY_OR_OTHER|||||||0.708|||||||one-sided, two-sample t-test|||||||0.708
71076566|NCT01410240|141661969|SUPERIORITY_OR_OTHER|||||||0.527|||||||one-sided, two-sample t-test|||||||0.527
71076567|NCT01410240|141661970|SUPERIORITY_OR_OTHER|||||||0.561|||||||one-sided Wilcoxon rank sum test|||||||0.561
71076568|NCT01410240|141661971|SUPERIORITY_OR_OTHER|||||||0.356|||||||one-sided Wilcoxon rank sum test|||||||0.356
71076569|NCT01410240|141661972|SUPERIORITY_OR_OTHER|||||||0.533|||||||one-sided Wilcoxon rank sum test|||||||0.533
71076570|NCT01410240|141661973|SUPERIORITY_OR_OTHER|||||||0.734|||||||two-sided Wilcoxon rank sum test|||||||0.734
71076571|NCT01410240|141661976|SUPERIORITY_OR_OTHER|||||||0.314|||||||two-sided Wilcoxon rank sum test|||||||0.314
71076572|NCT01410240|141661977|SUPERIORITY_OR_OTHER|||||||0.063|||||||two-sided Wilcoxon rank sum test|||||||0.063
71116919|NCT01559259|141740576|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|24.85|||<|0.001|TWO_SIDED|95.0|18.93|30.78|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||30.78|18.93|<0.001
71076573|NCT01410240|141661980|SUPERIORITY_OR_OTHER|||||||0.058|||||||two-sided Wilcoxon rank sum test|||||||0.058
71076574|NCT01410240|141661981|SUPERIORITY_OR_OTHER|||||||0.421|||||||two-sided Wilcoxon rank sum test|||||||0.421
71076575|NCT01410240|141661982|SUPERIORITY_OR_OTHER|||||||0.161|||||||two-sided Wilcoxon rank sum test|||||||0.161
71076576|NCT01410240|141661983|SUPERIORITY_OR_OTHER|||||||0.016|||||||two-sided Wilcoxon rank sum test|||||||0.016
71076577|NCT01410240|141661985|SUPERIORITY_OR_OTHER|||||||0.534|||||||two-sided Wilcoxon rank sum test|||Change Day 3: Pain||||0.534
71076578|NCT01410240|141661985|SUPERIORITY_OR_OTHER|||||||0.269|||||||two-sided Wilcoxon rank sum test|||Change Day 3: Stiffness||||0.269
71076579|NCT01410240|141661985|SUPERIORITY_OR_OTHER|||||||0.693|||||||two-sided Wilcoxon rank sum test|||Change Day 3: Physical Functioning||||0.693
71076580|NCT01410240|141661985|SUPERIORITY_OR_OTHER|||||||0.343|||||||two-sided Wilcoxon rank sum test|||Change Day 3: Average Score||||0.343
71076581|NCT01410240|141661985|SUPERIORITY_OR_OTHER|||||||0.343|||||||two-sided Wilcoxon rank sum test|||Change Day 3: Total Score||||0.343
71076582|NCT01410240|141661985|SUPERIORITY_OR_OTHER|||||||0.978|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Pain||||0.978
71076583|NCT01410240|141661985|SUPERIORITY_OR_OTHER|||||||0.709|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Stiffness||||0.709
70941040|NCT02592434|141381836|SUPERIORITY||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.31||0.0067|TWO_SIDED|95.0|-1.5|-0.25|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.25|-1.50|0.0067
71076584|NCT01410240|141661985|SUPERIORITY_OR_OTHER|||||||0.594|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Physical Functioning||||0.594
71076585|NCT01410240|141661985|SUPERIORITY_OR_OTHER|||||||0.501|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Average Score||||0.501
71076586|NCT01410240|141661985|SUPERIORITY_OR_OTHER|||||||0.501|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Total Score||||0.501
71076587|NCT01410240|141661985|SUPERIORITY_OR_OTHER|||||||0.171|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Pain||||0.171
71076588|NCT01410240|141661985|SUPERIORITY_OR_OTHER|||||||0.077|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Stiffness||||0.077
71076589|NCT01410240|141661985|SUPERIORITY_OR_OTHER|||||||0.026|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Physical Functioning||||0.026
71076590|NCT01410240|141661985|SUPERIORITY_OR_OTHER|||||||0.012|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Average Score||||0.012
71076591|NCT01410240|141661985|SUPERIORITY_OR_OTHER|||||||0.012|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Total Score||||0.012
71076592|NCT01410240|141661985|SUPERIORITY_OR_OTHER|||||||0.126|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Pain||||0.126
71076593|NCT01410240|141661985|SUPERIORITY_OR_OTHER|||||||0.044|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Stiffness||||0.044
71076594|NCT01410240|141661985|SUPERIORITY_OR_OTHER|||||||0.153||||||Change Week 6: Physical Functioning|two-sided Wilcoxon rank sum test|||||||0.153
71076595|NCT01410240|141661985|SUPERIORITY_OR_OTHER|||||||0.134|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Average Score||||0.134
71076596|NCT01410240|141661985|SUPERIORITY_OR_OTHER|||||||0.134|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Total Score||||0.134
71076597|NCT01410240|141661987|SUPERIORITY_OR_OTHER|||||||0.962|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Physical Functioning||||0.962
71076598|NCT01410240|141661987|SUPERIORITY_OR_OTHER|||||||0.714|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Role-Physical||||0.714
71076599|NCT01410240|141661987|SUPERIORITY_OR_OTHER|||||||0.668|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Bodily Pain||||0.668
71076600|NCT01410240|141661987|SUPERIORITY_OR_OTHER|||||||0.556|||||||two-sided Wilcoxon rank sum test|||Change Week 1: General Health||||0.556
71076601|NCT01410240|141661987|SUPERIORITY_OR_OTHER|||||||0.705|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Vitality||||0.705
71076602|NCT01410240|141661987|SUPERIORITY_OR_OTHER|||||||0.122|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Social Functioning||||0.122
71116920|NCT01559259|141740576|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.42||||0.501|TWO_SIDED|95.0|-2.73|5.58|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.58|-2.73|0.501
71076603|NCT01410240|141661987|SUPERIORITY_OR_OTHER|||||||0.254|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Role-Emotional||||0.254
71076604|NCT01410240|141661987|SUPERIORITY_OR_OTHER|||||||0.5|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Mental Health||||0.500
71076605|NCT01410240|141661987|SUPERIORITY_OR_OTHER|||||||0.849|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Physical Component Summary||||0.849
71076606|NCT01410240|141661987|SUPERIORITY_OR_OTHER|||||||0.959|||||||Wilcoxon (Mann-Whitney)|||Change Week 1: Mental Component Summary||||0.959
71076607|NCT01410240|141661987|SUPERIORITY_OR_OTHER|||||||0.574|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Physical Functioning||||0.574
71076608|NCT01410240|141661987|SUPERIORITY_OR_OTHER|||||||0.524|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Role-Physical||||0.524
71076609|NCT01410240|141661987|SUPERIORITY_OR_OTHER|||||||0.049|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Bodily Pain||||0.049
71076610|NCT01410240|141661987|SUPERIORITY_OR_OTHER|||||||0.447|||||||two-sided Wilcoxon rank sum test|||Change Week 2: General Health||||0.447
71076611|NCT01410240|141661987|SUPERIORITY_OR_OTHER|||||||0.823|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Vitality||||0.823
71076612|NCT01410240|141661987|SUPERIORITY_OR_OTHER|||||||0.661|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Social Functioning||||0.661
71076613|NCT01410240|141661987|SUPERIORITY_OR_OTHER|||||||0.086|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Role-Emotional||||0.086
71076614|NCT01410240|141661987|SUPERIORITY_OR_OTHER|||||||0.635|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Mental Health||||0.635
71076615|NCT01410240|141661987|SUPERIORITY_OR_OTHER|||||||0.481|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Physical Component Summary||||0.481
71076616|NCT01410240|141661987|SUPERIORITY_OR_OTHER|||||||0.14|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Mental Component Summary||||0.140
71076617|NCT01410240|141661987|SUPERIORITY_OR_OTHER|||||||0.107|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Physical Functioning||||0.107
71076618|NCT01410240|141661987|SUPERIORITY_OR_OTHER|||||||0.298|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Role-Physical||||0.298
71076619|NCT01410240|141661987|SUPERIORITY_OR_OTHER|||||||0.071|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Bodily Pain||||0.071
71076620|NCT01410240|141661987|SUPERIORITY_OR_OTHER|||||||0.94|||||||two-sided Wilcoxon rank sum test|||Change Week 6: General Health||||0.940
71076621|NCT01410240|141661987|SUPERIORITY_OR_OTHER|||||||0.293|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Vitality||||0.293
71076622|NCT01410240|141661987|SUPERIORITY_OR_OTHER|||||||0.265|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Social Functioning||||0.265
71076623|NCT01410240|141661987|SUPERIORITY_OR_OTHER|||||||0.036|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Role-Emotional||||0.036
71076624|NCT01410240|141661987|SUPERIORITY_OR_OTHER|||||||0.307|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Mental Health||||0.307
71076625|NCT01410240|141661987|SUPERIORITY_OR_OTHER|||||||0.448|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Physical Component Summary||||0.448
71076626|NCT01410240|141661987|SUPERIORITY_OR_OTHER|||||||0.255|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Mental Component Summary||||0.255
71076627|NCT01410240|141661989|SUPERIORITY_OR_OTHER|||||||0.052|||||||two-sided Wilcoxon rank sum test|||||||0.052
71076628|NCT02722746|141662018|SUPERIORITY||percent difference|20.8||||0.165|TWO_SIDED|95.0|-8.9|47.3|||Z-test for proportions|||||47.3|-8.9|0.165
71076629|NCT02722746|141662018|SUPERIORITY||percent difference|14.4||||0.353|TWO_SIDED|95.0|-15.9|42.2|||Z-test for proportions|||||42.2|-15.9|0.353
71076630|NCT02722746|141662019|SUPERIORITY|||||||0.06|||||||Kruskal-Wallis|||For PACU spread||||0.06
71076631|NCT02722746|141662019|SUPERIORITY|||||||0.22|||||||Kruskal-Wallis|||For Pre-op spread||||0.22
71076632|NCT02722746|141662019|SUPERIORITY|||||||0.74|||||||Kruskal-Wallis|||For POD 1||||0.74
71076633|NCT02722746|141662020|SUPERIORITY|||||||0.551|||||||ANOVA|||||||0.551
71076634|NCT02722746|141662021|SUPERIORITY|||||||0.349|||||||Mixed Models Analysis|||||||0.349
71076635|NCT02722746|141662022|SUPERIORITY|||||||0.18|||||||Fisher Exact|||For Pruritis||||0.18
71076636|NCT02722746|141662022|SUPERIORITY|||||||0.44|||||||Fisher Exact|||For Nausea/Vomiting||||0.44
71076637|NCT02722746|141662022|SUPERIORITY|||||||0.74|||||||Fisher Exact|||For Respirartory Depression||||0.74
71076638|NCT02722746|141662026|SUPERIORITY|||||||0.524|||||||ANOVA|||For SBP||||0.524
71076639|NCT02722746|141662026|SUPERIORITY|||||||0.585|||||||ANOVA|||For DBP||||0.585
71076640|NCT02722746|141662026|SUPERIORITY|||||||0.199|||||||ANOVA|||For MAP||||0.199
71076641|NCT02722746|141662027|SUPERIORITY|||||||0.231|||||||Mixed Models Analysis|||||||0.231
71076642|NCT02722746|141662028|SUPERIORITY|||||||0.016|||||||ANOVA|||||||0.016
71076643|NCT02722746|141662029|SUPERIORITY|||||||0.055|||||||ANOVA|||||||0.055
71116921|NCT01559259|141740576|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.49||||0.817|TWO_SIDED|95.0|-4.61|3.64|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.64|-4.61|0.817
71116922|NCT01559259|141740576|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.62||||0.216|TWO_SIDED|95.0|-1.53|6.78|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.78|-1.53|0.216
71116923|NCT01559259|141740577|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|12.69|||<|0.001|TWO_SIDED|95.0|5.52|29.19|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||29.19|5.52|<0.001
71116924|NCT01559259|141740577|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|10.02|||<|0.001|TWO_SIDED|95.0|4.36|23.02|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||23.02|4.36|<0.001
71116925|NCT01559259|141740577|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|11.66|||<|0.001|TWO_SIDED|95.0|5.07|26.83|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||26.83|5.07|<0.001
71116926|NCT01559259|141740577|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|8.6|||<|0.001|TWO_SIDED|95.0|3.74|19.77|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||19.77|3.74|<0.001
71116927|NCT01559259|141740577|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.48||||0.014|TWO_SIDED|95.0|1.08|2.02|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||2.02|1.08|0.014
71116928|NCT01559259|141740577|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17||||0.332|TWO_SIDED|95.0|0.86|1.59|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||1.59|0.86|0.332
71116929|NCT01559259|141740577|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.36||||0.056|TWO_SIDED|95.0|0.99|1.85|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||1.85|0.99|0.056
71116930|NCT01559259|141740578|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|12.1|||<|0.001|TWO_SIDED|95.0|5.24|27.91|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||27.91|5.24|<0.001
71116931|NCT01559259|141740578|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|8.88|||<|0.001|TWO_SIDED|95.0|3.86|20.44|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||20.44|3.86|<0.001
71116932|NCT01559259|141740578|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|11.47|||<|0.001|TWO_SIDED|95.0|4.98|26.42|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||26.42|4.98|<0.001
71116933|NCT01559259|141740578|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|8.11|||<|0.001|TWO_SIDED|95.0|3.52|18.68|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||18.68|3.52|<0.001
70853700|NCT02788279|141195531|SUPERIORITY||Hazard Ratio (HR)|1.39||||0.0509|TWO_SIDED|95.0|1.0|1.94|||Stratified Log-Rank|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|Hazard ratio was estimated using stratified Cox regression.|||1.94|1.00|0.0509
71076644|NCT02722746|141662030|SUPERIORITY|||||||0.567|||||||ANOVA|||||||0.567
71116934|NCT01559259|141740578|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.49||||0.012|TWO_SIDED|95.0|1.09|2.04|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||2.04|1.09|0.012
71116935|NCT01559259|141740578|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.09||||0.57|TWO_SIDED|95.0|0.8|1.49|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||1.49|0.80|0.570
70853701|NCT02788279|141195531|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.1726|TWO_SIDED|95.0|0.92|1.6|||Unstratified Log-Rank||Hazard ratio was estimated using unstratified Cox regression.|||1.60|0.92|0.1726
70853702|NCT02788279|141195531|SUPERIORITY||Hazard Ratio (HR)|1.39||||0.0467|TWO_SIDED|95.0|1.0|1.91|||Unstratified Log-Rank||Hazard ratio was estimated using unstratified Cox regression.|||1.91|1.00|0.0467
71076645|NCT03706469|141662031|EQUIVALENCE|Bioequivalence in the AUClast will be concluded if the 90 percent (%) confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of Geometric Mean Ratio (GMR)|83.6|||||TWO_SIDED|90.0|74.5|93.8||||||||93.80|74.50|
71076646|NCT03706469|141662031|EQUIVALENCE|Bioequivalence in the AUClast will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|102.22|||||TWO_SIDED|90.0|91.1|114.7||||||||114.70|91.10|
71076647|NCT03706469|141662031|EQUIVALENCE|Bioequivalence in the AUClast will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|172.73|||||TWO_SIDED|90.0|152.55|195.58||||||||195.58|152.55|
71076648|NCT03706469|141662032|EQUIVALENCE|Bioequivalence in the AUC∞ will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|84.29|||||TWO_SIDED|90.0|73.92|96.11||||||||96.11|73.92|
71076649|NCT03706469|141662032|EQUIVALENCE|Bioequivalence in the AUC∞ will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|99.61|||||TWO_SIDED|90.0|88.88|111.63||||||||111.63|88.88|
71076650|NCT03706469|141662032|EQUIVALENCE|Bioequivalence in the AUC∞ will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|172.7|||||TWO_SIDED|90.0|149.07|200.09||||||||200.09|149.07|
71076651|NCT03706469|141662033|EQUIVALENCE|Bioequivalence in the Cmax will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|79.14|||||TWO_SIDED|90.0|67.36|92.99||||||||92.99|67.36|
71076652|NCT03706469|141662033|EQUIVALENCE|Bioequivalence in the Cmax will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|99.8|||||TWO_SIDED|90.0|84.94|117.27||||||||117.27|84.94|
71076653|NCT03706469|141662033|EQUIVALENCE|Bioequivalence in the Cmax will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|173.3|||||TWO_SIDED|90.0|150.05|200.16||||||||200.16|150.05|
71076654|NCT01134263|141662039|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.055|||||TWO_SIDED|95.0|-0.067|0.178||||||Dengue Virus Serotype 1: Phase III Lot 1 vs Lot 2||0.178|-0.067|
71076655|NCT01134263|141662039|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.024|||||TWO_SIDED|95.0|-0.102|0.151||||||Dengue Virus Serotype 1: Phase III Lot 2 vs Lot 3||0.151|-0.102|
71076656|NCT01134263|141662039|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.08|||||TWO_SIDED|95.0|-0.204|0.045||||||Dengue Virus Serotype 1: Phase III Lot 3 vs Lot 1||0.045|-0.204|
71076657|NCT01134263|141662039|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.174|||||TWO_SIDED|95.0|0.009|0.34||||||Dengue Virus Serotype 2: Phase III Lot 1 vs Lot 2||0.340|0.009|
71076658|NCT01134263|141662039|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.12|||||TWO_SIDED|95.0|-0.297|0.056||||||Dengue Virus Serotype 2: Phase III Lot 2 vs Lot 3||0.056|-0.297|
71076659|NCT01134263|141662039|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.054|||||TWO_SIDED|95.0|-0.225|0.117||||||Dengue Virus Serotype 2: Phase III Lot 3 vs Lot 1||0.117|-0.225|
71076660|NCT01134263|141662039|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.058|||||TWO_SIDED|95.0|-0.068|0.184||||||Dengue Virus Serotype 3: Phase III Lot 1 vs Lot 2||0.184|-0.068|
71076661|NCT01134263|141662039|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.042|||||TWO_SIDED|95.0|-0.167|0.082||||||Dengue Virus Serotype 3: Phase III Lot 2 vs Lot 3||0.082|-0.167|
71076662|NCT01134263|141662039|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.016|||||TWO_SIDED|95.0|-0.144|0.113||||||Dengue Virus Serotype 3: Phase III Lot 3 vs Lot 1||0.113|-0.144|
71076663|NCT01134263|141662039|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.144|||||TWO_SIDED|95.0|-0.006|0.295||||||Dengue Virus Serotype 4: Phase III Lot 1 vs Lot 2||0.295|-0.006|
71076664|NCT01134263|141662039|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.06|||||TWO_SIDED|95.0|-0.207|0.088||||||Dengue Virus Serotype 4: Phase III Lot 2 vs Lot 3||0.088|-0.207|
71076665|NCT01134263|141662039|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.085|||||TWO_SIDED|95.0|-0.242|0.073||||||Dengue Virus Serotype 4: Phase III Lot 3 vs Lot 1||0.073|-0.242|
71076666|NCT01134263|141662040|EQUIVALENCE|Equivalence between the pooled Phase III and Phase II was demonstrated if, for each serotype the lower limit of the 95%CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.091|||||TWO_SIDED|95.0|-0.009|0.192||||||Dengue Virus Serotype 1||0.192|-0.009|
71076667|NCT01134263|141662040|EQUIVALENCE|Equivalence between the pooled Phase III and Phase II was demonstrated if, for each serotype the lower limit of the 95%CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.334|||||TWO_SIDED|95.0|0.202|0.466||||||Dengue Virus Serotype 2||0.466|0.202|
71116936|NCT01559259|141740578|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.41||||0.03|TWO_SIDED|95.0|1.03|1.93|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||1.93|1.03|0.030
71076668|NCT01134263|141662040|EQUIVALENCE|Equivalence between the pooled Phase III and Phase II was demonstrated if, for each serotype the lower limit of the 95%CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.076|||||TWO_SIDED|95.0|-0.173|0.021||||||Dengue Virus Serotype 3||0.021|-0.173|
71076669|NCT01134263|141662040|EQUIVALENCE|Equivalence between the pooled Phase III and Phase II was demonstrated if, for each serotype the lower limit of the 95%CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.017|||||TWO_SIDED|95.0|-0.137|0.103||||||Dengue Virus Serotype 4||0.103|-0.137|
71076670|NCT01618916|141662098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-49.92|||<|0.001||90.0|-63.84|-35.99|||Mixed Effects Model Analysis|P-value is for Day 43.||||-35.99|-63.84|<0.001
71076671|NCT01618916|141662098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.85|||<|0.001||90.0|-48.78|-20.93|||Mixed Effects Model Analysis|P-value is for Day 57.||||-20.93|-48.78|<0.001
71076672|NCT01618916|141662098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-47.72|||<|0.001||90.0|-62.1|-33.34|||Mixed Effects Model Analysis|P-value is for Day 43.||||-33.34|-62.10|<0.001
71076673|NCT01618916|141662098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-32.26|||<|0.001||90.0|-46.69|-17.82|||Mixed Effects Model Analysis|P-value is for Day 57.||||-17.82|-46.69|<0.001
71076674|NCT01618916|141662098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-45.36|||<|0.001||90.0|-60.07|-30.64|||Mixed Effects Model Analysis|P-value is for Day 43.||||-30.64|-60.07|<0.001
71076675|NCT01618916|141662098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-32.04|||<|0.001||90.0|-46.76|-17.32|||Mixed Effects Model Analysis|P-value is for Day 57.||||-17.32|-46.76|<0.001
71076676|NCT01618916|141662098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-46.8|||<|0.001||90.0|-61.12|-32.49|||Mixed Effects Model Analysis|P-value is for Day 43.||||-32.49|-61.12|<0.001
71076677|NCT01618916|141662098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-44.64|||<|0.001||90.0|-58.95|-30.32|||Mixed Effects Model Analysis|P-value is for Day 57.||||-30.32|-58.95|<0.001
71076678|NCT01618916|141662098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.53||||0.44||90.0|-20.51|7.44|||Mixed Effect Model Analysis|P-value is for Day 127||||7.44|-20.51|0.440
71076679|NCT01618916|141662098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.1||||0.108||90.0|-28.53|0.33|||Mixed Effect Model Analysis|P-value is for Day 127.||||0.33|-28.53|0.108
71076680|NCT01618916|141662098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.41||||0.013||90.0|-37.13|-7.69|||Mixed Effect Model Analysis|P-value is for Day 127.||||-7.69|-37.13|0.013
71076681|NCT01618916|141662098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.93||||0.042||90.0|-32.42|-3.44|||Mixed Effect Model Analysis|P-value is for Day 127.||||-3.44|-32.42|0.042
71076682|NCT02867202|141662120|OTHER||||||<|0.05|||||||t-test, 2 sided|||Data analysis was performed with SPSS version 22.0, using two-sided test, and a p value \< 0.05 was considered statistically significant.||||<0.05
71116937|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.39||||0.014|TWO_SIDED|95.0|0.08|0.71|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.71|0.08|0.014
71076683|NCT03292471|141662136|SUPERIORITY|Dependent variable: PNT T-score Fixed Effects: Group Assignment (A = Standard, B= Priming), Time point (Pre-treatment, Post-treatment) Random Effects: Participant (intercept and slope) Priors for slope and intercept were set as t-distributions (PNT raw score converted to T-score scale with m = 50, sd = 10 based on sample estimates from Fergadiotis, Hula, \& Kellough, 2015)|Highest Density Interval of Posterior Di|0.284|||||TWO_SIDED|95.0|-2.07|2.92|||||Direction of comparison: Group A (Standard Protocol) and post-treatment timepoint were set as reference values|Baysian Multivariate Analysis of Variance||2.92|-2.07|
71076684|NCT03292471|141662136|SUPERIORITY|Dependent variable: PNT T-score Fixed Effects: Group Assignment (A = Standard, B= Priming), Time point (Pre-treatment, Follow-up) Random Effects: Participant (intercept and slope) Priors for slope and intercept were set as t-distributions (PNT raw score converted to T-score scale with m = 50, sd = 10 based on sample estimates from Fergadiotis, Hula, \& Kellough, 2015)|Highest Density Interval of Posterior Di|0.02|||||TWO_SIDED|95.0|-2.38|2.46|||||Direction of comparison: Group A (Standard Protocol) and follow-up (2 months post-treatment) timepoint were set as reference values|Baysian Multivariate Analysis of Variance||2.46|-2.38|
71076685|NCT03292471|141662137|SUPERIORITY|Dependent variable: CAT Mean-modality T-score Fixed Effects: Group Assignment (A = Standard, B= Priming), Time point (Entry, Exit) Random Effects: Participant (intercept and slope) Priors for slope and intercept were set as t-distributions|Highest Density Interval of Posterior Di|0.997|||||TWO_SIDED|95.0|-0.0719|2.25|||||Direction of comparison: Group A (Standard Protocol) and post-treatment timepoint were set as reference values|Baysian Multivariate Analysis of Variance||2.25|-0.0719|
71076686|NCT03292471|141662137|SUPERIORITY|Dependent variable: CAT Mean-modality T-score Fixed Effects: Group Assignment (A = Standard, B= Priming), Time-point (Pre-treatment, Post-treatment) Random Effects: Participant (intercept and slope) Priors for slope and intercept were set as t-distributions|Highest Density Interval of Posterior Di|0.443|||||TWO_SIDED|95.0|-0.596|1.58|||||Direction of comparison: Group A (Standard Protocol) and follow-up (2 months post-treatment) timepoint were set as reference values|Baysian Multivariate Analysis of Variance||1.58|-0.596|
71076687|NCT00911586|141662144|OTHER|Part 1 of piecewise linear regression model.|Slope|-4.077|STANDARD_ERROR_OF_MEAN|16.02||0.806|TWO_SIDED||||||Regression, Linear|Part 1 of piecewise linear regression model.|Part 1 of piecewise linear regression model.|||||0.8060
71076688|NCT00911586|141662145|OTHER|Part 2 of piecewise linear regression model.|Slope|4.114|STANDARD_ERROR_OF_MEAN|18.456||0.8286|TWO_SIDED||||||Regression, Linear|Part 2 of piecewise linear regression model.|Part 2 of piecewise linear regression model.|||||0.8286
71076689|NCT03763058|141662174|SUPERIORITY||Mean Difference (Final Values)|-2.8|STANDARD_DEVIATION|4.19||0.012|TWO_SIDED|95.0|||||Sign test|||||||0.012
71076690|NCT03763058|141662175|SUPERIORITY||Mean Difference (Final Values)|-5.45|STANDARD_DEVIATION|15.52||0.002|TWO_SIDED|95.0|||||Sign test|||||||0.002
71076691|NCT03763058|141662176|SUPERIORITY||Mean Difference (Final Values)|-1.2|STANDARD_DEVIATION|2.71||0.045|TWO_SIDED|95.0|||||Sign test|||||||0.045
71076692|NCT03763058|141662177|SUPERIORITY||Mean Difference (Final Values)|-3.65|STANDARD_DEVIATION|4.59|<|0.001|TWO_SIDED|95.0|||||Sign test|||||||<0.001
71076693|NCT03763058|141662178|SUPERIORITY||Mean Difference (Final Values)|-4.15|STANDARD_DEVIATION|5.1|<|0.001|TWO_SIDED|95.0|||||Sign test|||Total HAD score||||<0.001
71076694|NCT03725033|141662221|SUPERIORITY|||||||0.0028|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and after 12 weeks row.||||0.0028
71076695|NCT03725033|141662222|SUPERIORITY|||||||0.0805|||||||Fisher Exact|||||||0.0805
71116938|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.33||||0.038|TWO_SIDED|95.0|0.02|0.64|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.64|0.02|0.038
71116939|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.48||||0.003|TWO_SIDED|95.0|0.17|0.79|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.79|0.17|0.003
70853703|NCT02788279|141195532|SUPERIORITY||Difference in Response Rates|0.51||||1|TWO_SIDED|95.0|-3.92|4.94|||Stratified Cochrane-Mantel-Haenszel|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|95% CI for difference in response rates was constructed using Hauck-Anderson method.|||4.94|-3.92|1.0000
70853704|NCT02788279|141195532|SUPERIORITY||Difference in Response Rates|0.0||||1|TWO_SIDED|95.0|-4.89|4.89|||Stratified Cochran-Mantel-Haenszel|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|95% CI for difference in response rates was constructed using Hauck-Anderson method.|||4.89|-4.89|1.0000
70853705|NCT00329849|141195540|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that for the serogroup A, the seroresponse percentage in the MenACWY-CRM group would be at least 10% lower than that in the MenACWY-PS group at one month postvaccination, i.e. the lower limit of the 95% CI of the difference in response rates (MenACWY-CRM minus MenACWY-PS) ≤-10%.|Group difference|38.0|||||TWO_SIDED|95.0|29.0|47.0|||Chi-squared|||Comparison of hSBA seroresponse for the serogroup A one month after vaccination of MenACWY-CRM and MenACWY-PS||47|29|
70853706|NCT00329849|141195540|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that for the serogroup C, the seroresponse percentage in the MenACWY-CRM group would be at least 10% lower than that in the MenACWY-PS group at one month postvaccination, i.e. the lower limit of the 95% CI of the difference in response rates (MenACWY-CRM minus MenACWY-PS) ≤-10%.|Group difference|30.0|||||TWO_SIDED|95.0|19.0|40.0|||Chi-squared|||Comparison of hSBA seroresponse for the serogroup C one month after vaccination of MenACWY-CRM and MenACWY-PS||40|19|
70853707|NCT00329849|141195540|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that for the serogroup W, the seroresponse percentage in the MenACWY-CRM group would be at least 10% lower than that in the MenACWY-PS group at one month postvaccination, i.e. the lower limit of the 95% CI of the difference in response rates (MenACWY-CRM minus MenACWY-PS) ≤-10%.|Group difference|28.0|||||TWO_SIDED|95.0|17.0|39.0|||Chi-squared|||Comparison of hSBA seroresponse for the serogroup W one month after vaccination of MenACWY-CRM and MenACWY-PS||39|17|
70853708|NCT00329849|141195540|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that for the serogroup Y, the seroresponse percentage in the MenACWY-CRM group would be at least 10% lower than that in the MenACWY-PS group at one month postvaccination, i.e. the lower limit of the 95% CI of the difference in response rates (MenACWY-CRM minus MenACWY-PS) ≤-10%.|Group difference|18.0|||||TWO_SIDED|95.0|8.0|28.0|||Chi-squared|||Comparison of hSBA seroresponse for the serogroup Y one month after vaccination of MenACWY-CRM and MenACWY-PS||28|8|
70853709|NCT00329849|141195541|NON_INFERIORITY_OR_EQUIVALENCE|Safety of MenACWY-CRM vaccination was considered non-inferior to the safety of MenACWY-PS vaccination if the upper limit of the two-sided 95% CI of the ratio (MenACWY-CRM group divided by MenACWY-PS group) of the percentage of subjects experiencing at least one severe systemic reaction during 1 to 7 days after vaccination was less than 3.|Group Ratio|6.37|||||TWO_SIDED|95.0|0.82|49.2|||Risk ratio(MenACWY-CRM/MenACWY-PS)|||||49.2|0.82|
70853710|NCT03996369|141195547|SUPERIORITY||Risk Difference (RD)|9.69|||=|0.026|TWO_SIDED|95.0|1.14|18.23|||Cochran-Mantel-Haenszel|||Week 12||18.23|1.14|=0.026
70853711|NCT03996369|141195548|SUPERIORITY||Risk Difference (RD)|12.11|||=|0.009|TWO_SIDED|95.0|3.0|21.23|||Cochran-Mantel-Haenszel|||Week 12||21.23|3.00|=0.009
70853712|NCT03996369|141195549|SUPERIORITY||Risk Difference (RD)|17.48|||=|0.001|TWO_SIDED|95.0|6.81|28.15|||Cochran-Mantel-Haenszel|||Week 12||28.15|6.81|=0.001
70853713|NCT03996369|141195550|SUPERIORITY||Risk Difference (RD)|7.44|||=|0.036|TWO_SIDED|95.0|0.5|14.39|||Cochran-Mantel-Haenszel|||Week 12||14.39|0.50|=0.036
70853714|NCT03996369|141195551|SUPERIORITY||Risk Difference (RD)|21.23|||<|0.001|TWO_SIDED|95.0|10.18|32.29|||Cochran-Mantel-Haenszel|||Week 12||32.29|10.18|<0.001
70853715|NCT03996369|141195552|SUPERIORITY||Risk Difference (RD)|9.24|||=|0.009|TWO_SIDED|95.0|2.27|16.2|||Cochran-Mantel-Haenszel|||Week 12||16.20|2.27|=0.009
70853716|NCT03996369|141195553|SUPERIORITY||Risk Difference (RD)|5.85|||=|0.115|TWO_SIDED|95.0|-1.42|13.13|||Cochran-Mantel-Haenszel|||Week 2||13.13|-1.42|=0.115
70853717|NCT03996369|141195553|SUPERIORITY||Risk Difference (RD)|11.83|||=|0.007|TWO_SIDED|95.0|3.19|20.47|||Cochran-Mantel-Haenszel|||Week 4||20.47|3.19|=0.007
70853718|NCT03996369|141195553|SUPERIORITY||Risk Difference (RD)|14.84|||=|0.003|TWO_SIDED|95.0|4.98|24.69|||Cochran-Mantel-Haenszel|||Week 8||24.69|4.98|=0.003
70853719|NCT03996369|141195554|SUPERIORITY||Risk Difference (RD)|2.83|||=|0.128|TWO_SIDED|95.0|-0.81|6.48|||Cochran-Mantel-Haenszel|||Week 2||6.48|-0.81|=0.128
71076696|NCT03725033|141662223|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and after 12 weeks row.||||0.99
71076697|NCT03725033|141662224|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and after 12 weeks row.||||0.79
71116940|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.23||||0.155|TWO_SIDED|95.0|-0.09|0.54|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.54|-0.09|0.155
71116941|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.17||||0.135|TWO_SIDED|95.0|-0.05|0.39|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.39|-0.05|0.135
71116942|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.1||||0.35|TWO_SIDED|95.0|-0.11|0.32|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.32|-0.11|0.350
71116943|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.25||||0.024|TWO_SIDED|95.0|0.03|0.47|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.47|0.03|0.024
71116944|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.33|||<|0.001|TWO_SIDED|95.0|0.9|1.77|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.77|0.90|<0.001
70853720|NCT03996369|141195554|SUPERIORITY||Risk Difference (RD)|8.32|||=|0.002|TWO_SIDED|95.0|3.01|13.64|||Cochran-Mantel-Haenszel|||Week 4||13.64|3.01|=0.002
71076698|NCT02638051|141662243|SUPERIORITY_OR_OTHER|||||||0.014|||||||Chi-squared|||"Applies to Objective Response Rate (ORR)"||||0.0140
71076699|NCT02638051|141662244|SUPERIORITY_OR_OTHER|||||||0.0016|||||||Chi-squared|||"Applies to All Adverse Events rate"||||0.0016
71076700|NCT02638051|141662244|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||"Applies to Abdominal pain rate"||||>0.05
71076701|NCT02638051|141662244|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||"Applies to Gastrointestinal reactions"||||>0.05
71116945|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.26|||<|0.001|TWO_SIDED|95.0|0.83|1.7|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.70|0.83|<0.001
71116946|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.35||||0.001|TWO_SIDED|95.0|0.91|1.78|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.78|0.91|0.001
71116947|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.87|||<|0.001|TWO_SIDED|95.0|0.43|1.3|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.30|0.43|<0.001
71076702|NCT02638051|141662244|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||"Applies to Damage of hepatic or renal function"||||>0.05
71076703|NCT02638051|141662244|SUPERIORITY_OR_OTHER|||||||0.0215|||||||Chi-squared|||"Applies to Bone marrow depression"||||0.0215
71076704|NCT02638051|141662245|SUPERIORITY_OR_OTHER|||||||0.0053|||||||Chi-squared|||"Applies to Better QoL"||||0.0053
71076705|NCT02638051|141662245|SUPERIORITY_OR_OTHER|||||||0.0527|||||||Chi-squared|||"Applies to No Change"||||0.0527
71116948|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.47||||0.003|TWO_SIDED|95.0|0.16|0.77|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.77|0.16|0.003
71116949|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.4||||0.01|TWO_SIDED|95.0|0.1|0.7|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.70|0.10|0.010
71116950|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.48||||0.002|TWO_SIDED|95.0|0.18|0.79|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.79|0.18|0.002
71116951|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.12|||<|0.001|TWO_SIDED|95.0|1.66|2.58|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.58|1.66|<0.001
71116952|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.96|||<|0.001|TWO_SIDED|95.0|1.5|2.42|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.42|1.50|<0.001
71116953|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.14|||<|0.001|TWO_SIDED|95.0|1.67|2.6|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.60|1.67|<0.001
71116954|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.74|||<|0.001|TWO_SIDED|95.0|1.28|2.2|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.20|1.28|<0.001
71116955|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.38||||0.022|TWO_SIDED|95.0|0.05|0.7|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.70|0.05|0.022
71116956|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.22||||0.181|TWO_SIDED|95.0|-0.1|0.54|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.54|-0.10|0.181
71116957|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.4||||0.016|TWO_SIDED|95.0|0.07|0.72|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.72|0.07|0.016
71116958|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.43|||<|0.001|TWO_SIDED|95.0|1.98|2.88|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.88|1.98|<0.001
71116959|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.17|||<|0.001|TWO_SIDED|95.0|1.72|2.62|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.62|1.72|<0.001
71116960|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.46|||<|0.001|TWO_SIDED|95.0|2.01|2.91|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.91|2.01|<0.001
71116961|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.13|||<|0.001|TWO_SIDED|95.0|1.68|2.58|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.58|1.68|<0.001
71116962|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.3||||0.065|TWO_SIDED|95.0|-0.02|0.61|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.61|-0.02|0.065
71116963|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.04||||0.817|TWO_SIDED|95.0|-0.28|0.35|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.35|-0.28|0.817
71116964|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.33||||0.043|TWO_SIDED|95.0|0.01|0.64|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.64|0.01|0.043
71076706|NCT02638051|141662245|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||"Applies to Worse QoL"||||>0.05
71076707|NCT00508157|141662252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.28|||||TWO_SIDED|95.0|-19.14|-2.66|||ANCOVA|ANCOVA model: log of on-treatment to baseline ratio = log of baseline value, treatment, previous antipsychotic.|Relative difference of Aripiprazole vs. Control Group in terms of (mean % change from baseline/100)+1.|Null hypothesis: no difference in mean percent change from baseline in fasting non-HDLC between aripiprazole and the control group at Week 16||-2.66|-19.14|
70941041|NCT02592434|141381836|SUPERIORITY||LS mean difference|-0.99|STANDARD_ERROR_OF_MEAN|0.37||0.0091|TWO_SIDED|95.0|-1.73|-0.25|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.25|-1.73|0.0091
70941042|NCT02592434|141381836|SUPERIORITY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.28||0.0632|TWO_SIDED|95.0|-1.09|0.03|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.03|-1.09|0.0632
71076708|NCT00508157|141662253|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.54|1.06|||Cochran-Mantel-Haenszel|A relative risk \< 1 favors Aripiprazole over Control Group.||null hypothesis: no difference between Aripiprazole and Control Group||1.06|0.54|
71076709|NCT01625689|141662298|SUPERIORITY_OR_OTHER||||||>=|0.498|TWO_SIDED|||||No comparison between the LAIV and placebo groups by type of solicited reaction had a p-value below 0.498.|Fisher Exact|||||||>=0.498
71076710|NCT04114656|141662312|OTHER||Posterior Ratio to placebo|0.993|||||TWO_SIDED|95.0|0.968|1.02|||||Treatment comparison ratio of GSK3858279 and placebo using posterior median ratio and 95% credible interval is presented. Analysis was performed using Bayesian Mixed Repeated measures Analysis of Covariance (ANCOVA) model.|||1.020|0.968|
70941043|NCT02592434|141381836|SUPERIORITY||LS mean difference|-0.71|STANDARD_ERROR_OF_MEAN|0.32||0.0306|TWO_SIDED|95.0|-1.35|-0.07|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.07|-1.35|0.0306
71076711|NCT04114656|141662313|OTHER||Posterior ratio to placebo|1.0|||||TWO_SIDED|95.0|0.89|1.12|||||Treatment comparison ratio of GSK3858279 and placebo using posterior median ratio and 95% credible interval is presented. Analysis was performed using Bayesian Mixed Repeated measures Analysis of Covariance (ANCOVA) model.|||1.12|0.89|
71076712|NCT04114656|141662314|OTHER||Posterior ratio to placebo|0.98|||||TWO_SIDED|95.0|0.91|1.05|||||Treatment comparison ratio of GSK3858279 and placebo using posterior median ratio and 95% credible interval is presented. Analysis was performed using Bayesian Mixed Repeated measures Analysis of Covariance (ANCOVA) model.|||1.05|0.91|
71076713|NCT03282591|141662315|SUPERIORITY||Mean Difference (Final Values)|31.4||||0.9942|ONE_SIDED|95.0||56.9|||Mixed Models Analysis|||||56.9||0.9942
71076714|NCT02173379|141662379|NON_INFERIORITY|One-sided p-value by using Farrington-Manning non-inferiority test statistic with non-inferiority margin of 2.9%, to be compared with a one-sided significance level of 0.025.||||||0.0244|ONE_SIDED|97.5|||||Farrington-Manning|||"The hypothesis test is designed to show non-inferiority of Absorb BVS to XIENCE for the primary endpoint with a one-sided alpha of 0.025. The null (H0) and alternative (HA) hypotheses are:~H0: TLFAbsorb - TLFXIENCE ≥ ∆TLF HA: TLFAbsorb - TLFXIENCE \< ∆TLF."||||0.0244
71076715|NCT02173379|141662380|NON_INFERIORITY|One-sided p-value by using Farrington-Manning non-inferiority test statistic with non-inferiority margin of 4.8%, to be compared with a one-sided significance level of 0.025.||||||0.0006|||||||Farrington-Manning|||||||0.0006
71076716|NCT04767529|141662571|SUPERIORITY||percent difference|22.6||||0.025|TWO_SIDED|95.0|3.8|41.4||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparison between the EFX 28 mg and placebo group|% difference from placebo (efruxifermin 28 mg - placebo)|Comparison between proportion of participants in efruxifermin 28 mg group who met the primary endpoint vs the placebo group||41.4|3.8|0.025
71076717|NCT04767529|141662571|SUPERIORITY||percent difference|22.5||||0.036|TWO_SIDED|95.0|1.6|43.3||Threshold for significance was p\<0.05|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for stratification factors is used for comparison between the EFX 50 mg and placebo group|% difference from placebo (efruxifermin 50 mg - placebo)|Comparison between proportion of participants in efruxifermin 50 mg group who met the primary endpoint vs the placebo group||43.3|1.6|0.036
71076718|NCT04767529|141662572|SUPERIORITY||percent difference|21.8||||0.07|TWO_SIDED|95.0|-1.3|45.0||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 28 mg and placebo group||||45.0|-1.3|0.070
71076719|NCT04767529|141662572|SUPERIORITY||percent difference|51.9|||<|0.001|TWO_SIDED|95.0|31.2|72.7||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 50 mg and placebo group||Week 96||72.7|31.2|<0.001
71076720|NCT04767529|141662573|SUPERIORITY||percent difference|31.9||||0.002|TWO_SIDED|95.0|12.9|50.9||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparison between the efruxifermin 28 mg and placebo group||Week 24||50.9|12.9|0.002
71076721|NCT04767529|141662573|SUPERIORITY||percent difference|61.7|||<|0.001|TWO_SIDED|95.0|44.1|79.4||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 50 mg and placebo groups||Week 24||79.4|44.1|<0.001
71076722|NCT04767529|141662573|SUPERIORITY||percent difference|38.9||||0.002|TWO_SIDED|95.0|17.2|60.7||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between efruxifermin 28 mg and placebo groups||Week 96||60.7|17.2|0.002
71076723|NCT04767529|141662573|SUPERIORITY||percent difference|33.2||||0.006|TWO_SIDED|95.0|10.5|55.8||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 50 mg and placebo group||Week 96||55.8|10.5|0.006
71076724|NCT04767529|141662574|SUPERIORITY||percent difference|20.0||||0.053|TWO_SIDED|95.0|0.4|39.5||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 28 mg and placebo group||Week 24||39.5|0.4|0.053
71076725|NCT04767529|141662574|SUPERIORITY||percent difference|19.9||||0.069|TWO_SIDED|95.0|-1.5|41.2||Threshold for statistical significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 50 mg and placebo groups||Week 24||41.2|-1.5|0.069
71076726|NCT04767529|141662574|SUPERIORITY||percent difference|19.0||||0.123|TWO_SIDED|95.0|-4.8|42.8||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 28 mg and placebo groups||Week 96||42.8|-4.8|0.123
71076727|NCT04767529|141662574|SUPERIORITY||percent difference|49.0|||<|0.001|TWO_SIDED|95.0|27.7|70.2||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 50 mg and placebo groups||Week 96||70.2|27.7|<0.001
71076728|NCT04767529|141662575|SUPERIORITY|Week 24|Mean Difference (Net)|-6.9|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-9.09|-4.71||Threshold for significance set at p\<0.05|Mixed Models Analysis|MMRM: fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction and baseline as covariate for comparison||Percent change from baseline in hepatic fat fraction between the EFX 28 mg and placebo groups||-4.71|-9.09|<0.001
70853721|NCT03996369|141195554|SUPERIORITY||Risk Difference (RD)|7.06|||=|0.032|TWO_SIDED|95.0|0.62|13.49|||Cochran-Mantel-Haenszel|||Week 8||13.49|0.62|=0.032
70941044|NCT02592434|141381836|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.31||0.0118|TWO_SIDED|95.0|-1.41|-0.18|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.18|-1.41|0.0118
71076729|NCT04767529|141662575|SUPERIORITY|Week 24|Mean Difference (Net)|-9.2|STANDARD_ERROR_OF_MEAN|1.12|<|0.001|TWO_SIDED|95.0|-11.47|-7.02||Threshold for significance set at p\<0.05|Mixed Models Analysis|MMRM:fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction and baseline as covariates for comparison||Percent change from baseline in hepatic fat fraction between the EFX 50 mg and placebo groups||-7.02|-11.47|<0.001
71076730|NCT04767529|141662575|SUPERIORITY|Week 96|Mean Difference (Net)|-3.8|STANDARD_ERROR_OF_MEAN|1.31||0.005|TWO_SIDED|95.0|-6.39|-1.18||Threshold for significance set at p\<0.05|Mixed Models Analysis|MMRM:fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction and baseline as covariates for comparison||Percent change from baseline in hepatic fat fraction between the EFX 28 mg and placebo groups||-1.18|-6.39|0.005
71076731|NCT04767529|141662575|SUPERIORITY|Week 96|Mean Difference (Net)|-5.8|STANDARD_ERROR_OF_MEAN|1.29|<|0.001|TWO_SIDED|95.0|-8.38|-3.25||Threshold for significance set at p\<0.05|Mixed Models Analysis|MMRM:fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction and baseline as covariates for comparison||Percent change from baseline in hepatic fat fraction between the EFX 50 mg and placebo groups||-3.25|-8.38|<0.001
71076732|NCT04767529|141662576|SUPERIORITY|Week 24|Mean Difference (Net)|-51.6|STANDARD_ERROR_OF_MEAN|9.86|<|0.001|TWO_SIDED|95.0|-71.17|-32.11|||Mixed Models Analysis|||Treatment comparison of least squares (LS) mean change from baseline (EFX 28 mg - placebo) in triglycerides (mg/dL)||-32.11|-71.17|<0.001
71076733|NCT04767529|141662576|SUPERIORITY|Week 24|Mean Difference (Net)|-55.2|STANDARD_ERROR_OF_MEAN|9.83|<|0.001|TWO_SIDED|95.0|-74.63|-35.71|||Mixed Models Analysis|||Treatment comparison of least squares (LS) mean change from baseline (EFX 50 mg - placebo) in triglycerides (mg/dL)||-35.71|-74.63|<0.001
71076734|NCT04767529|141662576|SUPERIORITY|Week 96|Mean Difference (Net)|-43.0|STANDARD_ERROR_OF_MEAN|11.48|<|0.001|TWO_SIDED|95.0|-65.73|-20.27||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of least squares (LS) mean change from baseline (EFX 28 mg - placebo) in triglycerides (mg/dL)||-20.27|-65.73|<0.001
71076735|NCT04767529|141662576|SUPERIORITY|Week 96|Mean Difference (Net)|-47.8|STANDARD_ERROR_OF_MEAN|11.4|<|0.001|TWO_SIDED|95.0|-70.39|-25.24||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in triglycerides (mg/dL)||-25.24|-70.39|<0.001
71076736|NCT04767529|141662576|SUPERIORITY|Week 24|Mean Difference (Net)|11.0|STANDARD_ERROR_OF_MEAN|1.58|<|0.001|TWO_SIDED|95.0|7.92|14.17|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 28 mg - placebo) in HDL cholesterol (mg/dL)||14.17|7.92|<0.001
71076737|NCT04767529|141662576|SUPERIORITY|Week 24|Mean Difference (Net)|12.5|STANDARD_ERROR_OF_MEAN|1.57|<|0.001|TWO_SIDED|95.0|9.35|15.57|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in HDL cholesterol (mg/dL)||15.57|9.35|<0.001
71076738|NCT04767529|141662576|SUPERIORITY|Week 96|Mean Difference (Net)|6.0|STANDARD_ERROR_OF_MEAN|2.12||0.005|TWO_SIDED|95.0|1.84|10.23||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of LS mean change from baseline (EFX 28 mg - placebo) in HDL cholesterol (mg/dL)||10.23|1.84|0.005
71076739|NCT04767529|141662576|SUPERIORITY|Week 96|Mean Difference (Net)|9.5|STANDARD_ERROR_OF_MEAN|2.11|<|0.001|TWO_SIDED|95.0|5.3|13.65||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in HDL cholesterol (mg/dL)||13.65|5.30|<0.001
71076740|NCT04767529|141662576|SUPERIORITY|Week 24|Mean Difference (Net)|-14.4|STANDARD_ERROR_OF_MEAN|4.99||0.005|TWO_SIDED|95.0|-24.28|-4.53|||Mixed Models Analysis|||Treatment comparison of change from baseline (EFX 28 mg - placebo) in LDL cholesterol (mg/dL)||-4.53|-24.28|0.005
71076741|NCT04767529|141662576|SUPERIORITY|Week 24|Median Difference (Net)|-13.6|STANDARD_ERROR_OF_MEAN|4.98||0.007|TWO_SIDED|95.0|-23.5|-3.76|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in LDL cholesterol (mg/dL)||-3.76|-23.50|0.007
71076742|NCT04767529|141662576|SUPERIORITY|Week 96|Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|7.04||0.99|TWO_SIDED|95.0|-13.86|14.04||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of change from baseline (EFX 28 mg - placebo) in LDL cholesterol (mg/dL)||14.04|-13.86|0.990
71116965|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.53|||<|0.001|TWO_SIDED|95.0|2.06|3.01|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.01|2.06|<0.001
71116966|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.34|||<|0.001|TWO_SIDED|95.0|1.87|2.82|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.82|1.87|<0.001
70941045|NCT01469819|141381866|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
70941046|NCT01469819|141381867|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
70941047|NCT01469819|141381868|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71076743|NCT04767529|141662576|SUPERIORITY|Week 96|Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|7.01||0.98|TWO_SIDED|95.0|-14.07|13.71||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in LDL cholesterol (mg/dL)||13.71|-14.07|0.980
71076744|NCT04767529|141662576|SUPERIORITY|Week 24|Mean Difference (Net)|-22.6|STANDARD_ERROR_OF_MEAN|5.52|<|0.001|TWO_SIDED|95.0|-33.58|-11.71|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 28 mg - placebo) in non-HDL cholesterol (mg/dL)||-11.71|-33.58|<0.001
71076745|NCT04767529|141662576|SUPERIORITY|Week 24|Mean Difference (Net)|-22.7|STANDARD_ERROR_OF_MEAN|5.51|<|0.001|TWO_SIDED|95.0|-33.56|-11.74|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 50mg - placebo) in non-HDL cholesterol (mg/dL)||-11.74|-33.56|<0.001
71076746|NCT04767529|141662576|SUPERIORITY|Week 96|Mean Difference (Net)|-6.1|STANDARD_ERROR_OF_MEAN|7.9||0.443|TWO_SIDED|95.0|-21.72|9.56||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of LS mean change from baseline (EFX 28 mg - placebo) in non-HDL cholesterol (mg/dL)||9.56|-21.72|0.443
70853722|NCT03996369|141195554|SUPERIORITY||Risk Difference (RD)|9.18|||=|0.014|TWO_SIDED|95.0|1.82|16.54|||Cochran-Mantel-Haenszel|||Week 12||16.54|1.82|=0.014
70853723|NCT03996369|141195555|SUPERIORITY||Risk Difference (RD)|15.55|||=|0.002|TWO_SIDED|95.0|5.65|25.46|||Cochran-Mantel-Haenszel|||Week 2||25.46|5.65|=0.002
70853724|NCT03996369|141195555|SUPERIORITY||Risk Difference (RD)|14.98|||=|0.007|TWO_SIDED|95.0|4.05|25.91|||Cochran-Mantel-Haenszel|||Week 4||25.91|4.05|=0.007
70853725|NCT03996369|141195555|SUPERIORITY||Risk Difference (RD)|22.6|||<|0.001|TWO_SIDED|95.0|11.95|33.25|||Cochran-Mantel-Haenszel|||Week 8||33.25|11.95|<0.001
70941048|NCT01469819|141381869|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
70941049|NCT02389725|141381910|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
70941050|NCT02389725|141381911|SUPERIORITY|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
70941051|NCT02389725|141381912|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||||||0.67
70941052|NCT02389725|141381913|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
71076747|NCT04767529|141662576|SUPERIORITY|Week 96|Mean Difference (Net)|-8.2|STANDARD_ERROR_OF_MEAN|7.86||0.299|TWO_SIDED|95.0|-23.77|7.36||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in non-HDL cholesterol (mg/dL)||7.36|-23.77|0.299
70941053|NCT00724750|141381921|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 5%/day. For 80% power and a significance (alpha) level of 0.05; and assuming a common standard deviation of 9%, 41 subjects per group were needed.||||||0.6|TWO_SIDED|||||The rate of change for the 2 groups was compared by testing the treatment-by-time interaction in the model.|Mixed Models Analysis|||||||0.60
70941054|NCT00724750|141381922|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 5%/day.||||||0.19|TWO_SIDED|||||The rate of change for the 2 groups was compared by testing the treatment-by-time interaction.|Mixed Models Analysis|||||||0.19
71076748|NCT04767529|141662585|SUPERIORITY|Week 24|Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|1.18||0.75|TWO_SIDED|95.0|-1.96|2.72||Threshold for significance set at p\<0.05|Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 28 mg - placebo) in body weight (kg)||2.72|-1.96|0.750
71076749|NCT04767529|141662585|SUPERIORITY|Week 24|Mean Difference (Net)|-2.4|STANDARD_ERROR_OF_MEAN|1.18||0.042|TWO_SIDED|95.0|-4.75|-0.09||Threshold for significance set at p\<0.05|Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in body weight (kg)||-0.09|-4.75|0.042
70941055|NCT00724750|141381924|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
70853726|NCT03996369|141195555|SUPERIORITY||Risk Difference (RD)|17.58|||=|0.002|TWO_SIDED|95.0|6.7|28.47|||Cochran-Mantel-Haenszel|||Week 12||28.47|6.70|=0.002
70853727|NCT03996369|141195556|SUPERIORITY||Risk Difference (RD)|15.99|||=|0.002|TWO_SIDED|95.0|6.07|25.91|||Cochran-Mantel-Haenszel|||Week 2||25.91|6.07|=0.002
70941056|NCT00724750|141381925|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|||||||0.02
70941057|NCT00724750|141381926|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
70941058|NCT03647709|141381948|OTHER||mean score|1.0|||||TWO_SIDED|95.0|0.9|1.2|||||Represents patients pain score post operative day 1 best with rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity.||1.2|0.9|
70941059|NCT03647709|141381948|OTHER||mean score|2.4|||||TWO_SIDED|95.0|2.2|2.6|||||Represents patients reported pain score post operative day 1 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity.||2.6|2.2|
70941060|NCT03647709|141381948|OTHER||mean score|2.9|||||TWO_SIDED|95.0|2.7|3.1|||||Represents patients reported pain score post operative day 1 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||3.1|2.7|
71076750|NCT04767529|141662585|SUPERIORITY|Week 96|Mean Difference (Net)|1.2|STANDARD_ERROR_OF_MEAN|2.07||0.564|TWO_SIDED|95.0|-2.9|5.29|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (28 mg EFX - placebo) in body weight (kg)||5.29|-2.90|0.564
71076751|NCT04767529|141662585|SUPERIORITY|Week 96|Mean Difference (Net)|-1.9|STANDARD_ERROR_OF_MEAN|2.06||0.348|TWO_SIDED|95.0|-6.02|2.14|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in body weight (kg)||2.14|-6.02|0.348
71076752|NCT04767529|141662586|SUPERIORITY|Week 24|Mean Difference (Net)|-2.1|STANDARD_ERROR_OF_MEAN|1.24||0.102|TWO_SIDED|95.0|-4.5|0.4|||Mixed Models Analysis|||Treatment comparison of change from baseline (EFX 28 mg - placebo) in Liver Stiffness Measurement (kPa)||0.4|-4.5|0.102
71076753|NCT04767529|141662586|SUPERIORITY|Week 24|Mean Difference (Net)|-3.3|STANDARD_ERROR_OF_MEAN|1.26||0.009|TWO_SIDED|95.0|-5.8|-0.8|||Mixed Models Analysis|||Treatment comparison of change from baseline (EFX 50 mg - placebo) in Liver Stiffness Measurement (kPa)||-0.8|-5.8|0.009
71076754|NCT04767529|141662586|SUPERIORITY|Week 96|Mean Difference (Net)|-3.4|STANDARD_ERROR_OF_MEAN|1.43||0.021|TWO_SIDED|95.0|-6.2|-0.5||Threshold for significance set at P\<0.05|Mixed Models Analysis||LS Means, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX 28 mg and placebo group|Treatment comparison of change from baseline (EFX 28 mg - placebo) in Liver Stiffness Measurement (kPa)||-0.5|-6.2|0.021
71076755|NCT04767529|141662586|SUPERIORITY|Week 96|Mean Difference (Net)|-6.6|STANDARD_ERROR_OF_MEAN|1.43|<|0.001|TWO_SIDED|95.0|-9.4|-3.7|||Mixed Models Analysis||LS Means, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX 50 mg and placebo group|Treatment comparison of change from baseline (EFX 50 mg - placebo) in Liver Stiffness Measurement (kPa)||-3.7|-9.4|<0.001
71076756|NCT04348500|141662615|SUPERIORITY|||||||0.1||||||P-value was not adjusted.|Chi-squared|||The null hypothesis is that there is no difference in the use of clazakizumab as a treatment compared to placebo in reducing or eliminating the incidence of severe adverse events among patients with COVID-19.||||0.10
71076757|NCT04348500|141662621|SUPERIORITY|||||||0.1||||||P-value was not adjusted.|Fisher Exact|||Null hypothesis is that there is no change in the need for mechanical ventilation and/or ECMO at 14 days after the first administered dose in comparison to placebo.||||0.10
71076758|NCT02776670|141662622|NON_INFERIORITY|Noninferiority was deemed established if the lower limit of the 95% CI (equivalent to the 1-sided 97.5% CI) for the adjusted estimate of the difference (Systane Balance-Refresh Optive Advanced/Optive Plus) was above the noninferiority margin of -1.0 second.|Mean Difference (Final Values)|0.13|||<|0.0001|TWO_SIDED|95.0|-0.341|0.601||p-value for testing noninferiority of Systane Balance with respect to Refresh Optive Advanced/Refresh Optive Plus is calculated for predefined noninferiority margin of -1.0 second.|Mixed model repeated measures (MMRM)|||||0.601|-0.341|<0.0001
71076759|NCT02776670|141662623|SUPERIORITY||Mean Difference (Final Values)|0.118||||0.31|TWO_SIDED|95.0|-0.349|0.585|||MMRM|||||0.585|-0.349|0.310
71076760|NCT02776670|141662625|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.618|TWO_SIDED|95.0|-6.4|4.7|||MMRM|||||4.7|-6.4|0.618
71076761|NCT01937884|141662626|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
71076762|NCT01937884|141662627|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
71076763|NCT01937884|141662628|SUPERIORITY|||||||0.27|||||||t-test, 2 sided|Student's t-test on log-transformed change in IFABP.||||||0.27
71076764|NCT01937884|141662629|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|Student's t-test on log-transformed citrulline concentration on study day 5, by treatment group||||||0.04
71076765|NCT01937884|141662630|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|Student's t-test on log-transformed percent change of claudin 3||||||0.43
71076766|NCT01937884|141662631|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
71076767|NCT01937884|141662632|SUPERIORITY|||||||0.43|||||||Chi-squared|||||||0.43
71076768|NCT01937884|141662633|SUPERIORITY|||||||0.06|||||||Chi-squared|||||||0.06
71076769|NCT00981058|141662640|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.842||||0.012|TWO_SIDED|95.0|0.736|0.962|||Log Rank|||||0.962|0.736|0.0120
71076770|NCT00981058|141662641|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.851||||0.0201|TWO_SIDED|95.0|0.743|0.975|||Log Rank|||||0.975|0.743|0.0201
71076771|NCT00981058|141662642|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.3997|TWO_SIDED|95.0|0.86|1.45|||Cochran-Mantel-Haenszel|||||1.45|0.86|0.3997
71076772|NCT00981058|141662643|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.844||||0.0061|TWO_SIDED|95.0|0.747|0.953|||Log Rank|||||0.953|0.747|0.0061
71076773|NCT02667587|141662649|SUPERIORITY||Cox Proportional Hazard|1.06|||||TWO_SIDED|95.0|0.9|1.25||||||||1.25|0.90|
71076774|NCT02667587|141662650|SUPERIORITY||Cox Proportional Hazard|1.12||||0.3402|TWO_SIDED|96.39|0.87|1.43|||Log Rank|||All Randomized No Baseline Corticosteroids Participants||1.43|0.87|0.3402
71076775|NCT02667587|141662650|SUPERIORITY||Cox Proportional Hazard|1.1|||||TWO_SIDED|95.0|0.91|1.33||||||All Randomized Participants||1.33|0.91|
71076776|NCT02667587|141662654|SUPERIORITY||Cox Proportional Hazard|1.18|||||TWO_SIDED|95.0|0.99|1.4||||||||1.40|0.99|
71076777|NCT02667587|141662655|SUPERIORITY||Cox Proportional Hazard|1.06|||||TWO_SIDED|95.0|0.89|1.26|||Log Rank|||||1.26|0.89|
71076778|NCT04165135|141662656|OTHER|||||||0.763|||||||Kruskal-Wallis|||Heart zone minutes: Comparison among the age groups was performed by means of a Kruskal-Wallis test.||||0.7630
71076779|NCT04165135|141662656|OTHER|||||||0.0913|||||||Kruskal-Wallis|||Active zone minutes: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0913
71076780|NCT04165135|141662656|OTHER|||||||0.0956|||||||Kruskal-Wallis|||MVPA minutes: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0956
71076781|NCT04165135|141662657|OTHER|||||||0.0649|||||||Kruskal-Wallis|||||||0.0649
71076782|NCT04165135|141662658|OTHER|||||||0.0026|||||||Kruskal-Wallis|||||||0.0026
71076783|NCT04165135|141662659|OTHER|||||||0.9493|||||||Kruskal-Wallis|||Running: Comparison among age groups was performed using Kruskal-Wallis test.||||0.9493
70853728|NCT03996369|141195556|SUPERIORITY||Risk Difference (RD)|15.45|||=|0.006|TWO_SIDED|95.0|4.54|26.36|||Cochran-Mantel-Haenszel|||Week 4||26.36|4.54|=0.006
71076784|NCT04165135|141662659|OTHER|||||||0.8305|||||||Kruskal-Wallis|||Swimming: Comparison among age groups was performed using Kruskal-Wallis test.||||0.8305
71076785|NCT04165135|141662659|OTHER|||||||0.8725|||||||Kruskal-Wallis|||Tapis Roulant: Comparison among age groups was performed using Kruskal-Wallis test.||||0.8725
71076786|NCT04165135|141662659|OTHER|||||||0.338|||||||Kruskal-Wallis|||Gym Weights: Comparison among age groups was performed using Kruskal-Wallis test.||||0.3380
71076787|NCT04165135|141662659|OTHER|||||||0.9706|||||||Kruskal-Wallis|||Exercises at Intervals: Comparison among age groups was performed using Kruskal-Wallis test.||||0.9706
71076788|NCT04165135|141662659|OTHER|||||||0.1727|||||||Kruskal-Wallis|||General: Comparison among age groups was performed using Kruskal-Wallis test.||||0.1727
71076789|NCT04165135|141662659|OTHER|||||||0.0099|||||||Kruskal-Wallis|||Walk: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0099
71076790|NCT04165135|141662660|OTHER|||||||0.6151|||||||Kruskal-Wallis|||Running: Comparison among age groups was performed using Kruskal-Wallis test.||||0.6151
71076791|NCT04165135|141662660|OTHER|||||||0.9332|||||||Kruskal-Wallis|||Swimming: Comparison among age groups was performed using Kruskal-Wallis test.||||0.9332
71076792|NCT04165135|141662660|OTHER|||||||0.4726|||||||Kruskal-Wallis|||Tapis Roulant: Comparison among age groups was performed using Kruskal-Wallis test.||||0.4726
71076793|NCT04165135|141662660|OTHER|||||||0.4111|||||||Kruskal-Wallis|||Gym Weights: Comparison among age groups was performed using Kruskal-Wallis test.||||0.4111
71076794|NCT04165135|141662660|OTHER|||||||0.0892|||||||Kruskal-Wallis|||Exercises at Intervals: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0892
71076795|NCT04165135|141662660|OTHER|||||||0.1642|||||||Kruskal-Wallis|||General: Comparison among age groups was performed using Kruskal-Wallis test.||||0.1642
71076796|NCT04165135|141662660|OTHER|||||||0.7256|||||||Kruskal-Wallis|||Walk: Comparison among age groups was performed using Kruskal-Wallis test.||||0.7256
71076797|NCT04165135|141662661|OTHER|||||||0.0745|||||||Kruskal-Wallis|||Running: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0745
71076798|NCT04165135|141662661|OTHER|||||||0.2177|||||||Kruskal-Wallis|||Swimming: Comparison among age groups was performed using Kruskal-Wallis test.||||0.2177
71076799|NCT04165135|141662661|OTHER|||||||0.2121|||||||Kruskal-Wallis|||Tapis Roulant: Comparison among age groups was performed using Kruskal-Wallis test.||||0.2121
71076800|NCT04165135|141662661|OTHER|||||||0.2336|||||||Kruskal-Wallis|||Gym weights: Comparison among age groups was performed using Kruskal-Wallis test.||||0.2336
71076801|NCT04165135|141662661|OTHER|||||||0.419|||||||Kruskal-Wallis|||Exercises at intervals: Comparison among age groups was performed using Kruskal-Wallis test.||||0.4190
71076802|NCT04165135|141662661|OTHER|||||||0.0252|||||||Kruskal-Wallis|||General: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0252
71076803|NCT04165135|141662661|OTHER|||||||0.2143|||||||Kruskal-Wallis|||Walk: Comparison among age groups was performed using Kruskal-Wallis test.||||0.2143
71076804|NCT04165135|141662662|OTHER|||||||0.0085|||||||Kruskal-Wallis|||Running: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0085
71076805|NCT04165135|141662662|OTHER|||||||0.1098|||||||Kruskal-Wallis|||Swimming: Comparison among age groups was performed using Kruskal-Wallis test.||||0.1098
71076806|NCT04165135|141662662|OTHER|||||||0.2703|||||||Kruskal-Wallis|||Tapis Roulant: Comparison among age groups was performed using Kruskal-Wallis test.||||0.2703
70853729|NCT03996369|141195556|SUPERIORITY||Risk Difference (RD)|22.14|||<|0.001|TWO_SIDED|95.0|11.43|32.85|||Cochran-Mantel-Haenszel|||Week 8||32.85|11.43|<0.001
71076807|NCT04165135|141662662|OTHER|||||||0.3366|||||||Kruskal-Wallis|||Gym Weights: Comparison among age groups was performed using Kruskal-Wallis test.||||0.3366
71076808|NCT04165135|141662662|OTHER|||||||0.0992|||||||Kruskal-Wallis|||Exercises at Intervals: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0992
71076809|NCT04165135|141662662|OTHER|||||||0.1194|||||||Kruskal-Wallis|||General: Comparison among age groups was performed using Kruskal-Wallis test.||||0.1194
71076810|NCT04165135|141662662|OTHER|||||||0.0549|||||||Kruskal-Wallis|||Walk: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0549
71076811|NCT04165135|141662663|OTHER|||||||0.0088|||||||Chi-squared|||Comparison among age groups was performed using Chi-squared test.||||0.0088
71076812|NCT00497055|141662727|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88||||0.41||95.0|0.66|1.16|||Generalized estimating equation|||||1.16|.66|.41
71076813|NCT00497055|141662728|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.31
71076814|NCT00497055|141662729|SUPERIORITY_OR_OTHER||||||>=|0.99|||||||Fisher Exact|||||||>=0.99
71076815|NCT00094536|141662814|SUPERIORITY_OR_OTHER|||||||0.271|||||||1-sided z-test|1-sided z-test with continuity correction (pooled)||||||.271
71076816|NCT01900431|141662822|SUPERIORITY||Odds Ratio (OR)|2.1||||0.2354|TWO_SIDED|90.0|0.8|5.6||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using combined estimate for odds ratio obtained by combining the log-transformation of odds ratio from Cochran Mantel-Haenszel (CMH) analyses of the different imputed datasets, using Rubin's formulae, and then by back-transforming the combined estimate. The CMH analyses were adjusted for randomization stratification factor VH level (VH \>= 4 versus VH \<4).||5.6|0.8|0.2354
71076817|NCT01900431|141662823|SUPERIORITY||Least Square (LS) Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.29||0.0127|TWO_SIDED|90.0|-1.223|-0.262||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using mixed effect model with repeated measures (MMRM) with treatment groups, visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline adjudicated VH.||-0.262|-1.223|0.0127
71076818|NCT01900431|141662824|SUPERIORITY||Odds Ratio (OR)|0.95||||1|TWO_SIDED|90.0|0.11|6.093||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using common odds ratio which came from CMH analysis adjusted for randomization stratification factor VH level (VH \>=4 versus VH \<4).||6.093|0.11|1
71076819|NCT01900431|141662825|SUPERIORITY||LS Mean Difference|5.8|STANDARD_ERROR_OF_MEAN|2.26||0.0153|TWO_SIDED|90.0|1.99|9.67||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using MMRM model with treatment groups, randomization strata of VH level (\<4, \>=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline BCVA.||9.67|1.99|0.0153
70853730|NCT03996369|141195556|SUPERIORITY||Risk Difference (RD)|18.49|||<|0.001|TWO_SIDED|95.0|7.65|29.33|||Cochran-Mantel-Haenszel|||Week 12||29.33|7.65|<0.001
70853731|NCT02395172|141195597|SUPERIORITY||Hazard Ratio (HR)|0.87|||=|0.0721|TWO_SIDED|95.0|0.71|1.05|||Log Rank|||||1.05|0.71|= 0.0721
70853732|NCT02395172|141195598|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.77|1.05||||||||1.05|0.77|
70853733|NCT02395172|141195599|SUPERIORITY||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.8|1.27||||||||1.27|0.80|
70853734|NCT02395172|141195600|SUPERIORITY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.98|1.41||||||||1.41|0.98|
70853735|NCT02395172|141195603|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.92|2.13||||||||2.13|0.92|
70853736|NCT02395172|141195604|SUPERIORITY||Odds Ratio (OR)|1.76|||||TWO_SIDED|95.0|1.08|2.86||||||||2.86|1.08|
70853737|NCT00475982|141195653|SUPERIORITY||Mean Difference (Final Values)|0.965||||0.965|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.965
70853738|NCT00475982|141195654|SUPERIORITY||Mean Difference (Final Values)|0.884||||0.884|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.884
70853739|NCT00475982|141195655|SUPERIORITY|||||||0.294|||||||paired t-test|||intra-analysis within the weight loss arm||||0.294
70853740|NCT00475982|141195655|SUPERIORITY|||||||0.44|||||||paired t-test|||intra-analysis within the control arm||||0.440
70853741|NCT00475982|141195655|SUPERIORITY||Mean Difference (Net)|8.49||||0.186|TWO_SIDED|95.0|-4.31|21.3|||paired t-test|||analysis between the weight loss and control arms||21.3|-4.31|0.186
70853742|NCT00475982|141195656|SUPERIORITY|||||||0.162|||||||paired t-test|||intra-analysis within the weight loss arm||||0.162
70941061|NCT03647709|141381948|OTHER||mean score|4.6|||||TWO_SIDED|95.0|4.4|4.8|||||Represents patients reported pain score post operative day 1 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||4.8|4.4|
71076820|NCT01900431|141662826|SUPERIORITY||LS Mean Difference|-26.5|STANDARD_ERROR_OF_MEAN|14.2||0.0683|TWO_SIDED|90.0|-50.41|-2.68||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using MMRM model with treatment groups, randomization strata of VH level (\<4, \>=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline CRT (Automatic measurement from SD-OCT).||-2.68|-50.41|0.0683
71076821|NCT01900431|141662827|SUPERIORITY||LS Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|3.55||0.0825|TWO_SIDED|90.0|-12.374|-0.35||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using MMRM model with treatment groups, randomization strata of VH level (\<4, \>=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline CRT (Automatic measurement from SD-OCT).||-0.35|-12.374|0.0825
71076822|NCT01900431|141662830|SUPERIORITY||Odds Ratio (OR)|1.07||||1|TWO_SIDED|90.0|0.306|3.845||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using common odds ratio which came from CMH analysis adjusted for randomization stratification factor VH level (VH \>=4 versus VH \<4).||3.845|0.306|1
70853743|NCT00475982|141195656|SUPERIORITY|||||||0.986|||||||paired t-test|||intra-analysis within the control arm||||0.986
70941062|NCT03647709|141381948|OTHER||mean score|1.8|||||TWO_SIDED|95.0|1.6|2.0|||||Represents patients reported pain score post operative day 2 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||2.0|1.6|
71076823|NCT00603382|141662877|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.101||||0.095|TWO_SIDED|95.0|-0.018|0.221|||ANCOVA|||||0.221|-0.018|0.095
70941063|NCT03647709|141381948|OTHER||mean score|3.4|||||TWO_SIDED|95.0|3.2|3.6|||||Represents patients reported pain score post operative day 2 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||3.6|3.2|
70941064|NCT03647709|141381948|OTHER||mean score|4.2|||||TWO_SIDED|95.0|4.0|4.4|||||Represents patients reported pain score post operative day 2 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||4.4|4.0|
70941065|NCT03647709|141381948|OTHER||mean score|5.9|||||TWO_SIDED|95.0|5.7|6.1|||||Represents patients reported pain score post operative day 2 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||6.1|5.7|
70941066|NCT03647709|141381948|OTHER||mean score|1.0|||||TWO_SIDED|95.0|0.8|1.2|||||Represents patients reported pain score post operative day 3 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||1.2|0.8|
70941067|NCT03647709|141381948|OTHER||mean score|2.4|||||TWO_SIDED|95.0|2.2|2.6|||||Represents patients reported pain score post operative day 3 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||2.6|2.2|
70941068|NCT03647709|141381948|OTHER||mean score|3.3|||||TWO_SIDED|95.0|3.1|3.5|||||Represents patients reported pain score post operative day 3 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||3.5|3.1|
70941069|NCT03647709|141381948|OTHER||mean score|5.0|||||TWO_SIDED|95.0|4.8|5.2|||||Represents patients reported pain score post operative day 3 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||5.2|4.8|
70941070|NCT03647709|141381948|OTHER||mean score|0.5|||||TWO_SIDED|95.0|0.4|0.7|||||Represents patients reported pain score post operative days 10-14 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.7|0.4|
70941071|NCT03647709|141381948|OTHER||mean score|2.1|||||TWO_SIDED|95.0|1.9|2.3|||||Represents patients reported pain score post operative days 10-14 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||2.3|1.9|
70941072|NCT03647709|141381948|OTHER||mean score|2.0|||||TWO_SIDED|95.0|1.8|2.2|||||Represents patients reported pain score post operative days 10-14 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||2.2|1.8|
71076824|NCT00603382|141662877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129||||0.033|TWO_SIDED|95.0|0.011|0.247|||ANCOVA|||||0.247|0.011|0.033
70941073|NCT03647709|141381948|OTHER||mean score|4.0|||||TWO_SIDED|95.0|3.8|4.2|||||Represents patients reported pain score post operative days 10-14 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||4.2|3.8|
70941074|NCT03647709|141381948|OTHER||mean score|0.3|||||TWO_SIDED|95.0|0.2|0.4|||||Represents patients reported pain score post operative week 3 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.4|0.2|
70853744|NCT00475982|141195656|SUPERIORITY||Mean Difference (Net)|2.22||||0.353|TWO_SIDED|95.0|-2.58|7.02|||paired t-test|||analysis between the weight loss and control arms||7.02|-2.58|0.353
70941075|NCT03647709|141381948|OTHER||mean score|1.5|||||TWO_SIDED|95.0|1.3|1.7|||||Represents patients reported pain score post operative week 3 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||1.7|1.3|
70941076|NCT03647709|141381948|OTHER||mean score|1.3|||||TWO_SIDED|95.0|1.2|1.5|||||Represents patients reported pain score post operative week 3 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||1.5|1.2|
71076825|NCT00603382|141662877|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.204|||<|0.001|TWO_SIDED|95.0|0.089|0.319|||ANCOVA|||||0.319|0.089|<0.001
70853745|NCT00475982|141195657|SUPERIORITY|||||||0.283|||||||paired t-test|||intra-analysis within the weight loss arm||||0.283
70853746|NCT00475982|141195657|SUPERIORITY|||||||0.701|||||||paired t-test|||intra-analysis within the control arm||||0.701
71076826|NCT00603382|141662877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||<|0.001|TWO_SIDED|95.0|0.111|0.349|||ANCOVA|||||0.349|0.111|<0.001
70941077|NCT03647709|141381948|OTHER||mean score|3.1|||||TWO_SIDED|95.0|2.9|3.3|||||Represents patients reported pain score post operative week 3 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||3.3|2.9|
70941078|NCT03647709|141381948|OTHER||mean score|0.1|||||TWO_SIDED|95.0|0.0|0.2|||||Represents patients reported pain score post operative week 6 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.2|0.0|
70941079|NCT03647709|141381948|OTHER||mean score|0.7|||||TWO_SIDED|95.0|0.5|0.8|||||Represents patients reported pain score post operative week 6 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.8|0.5|
70941080|NCT03647709|141381948|OTHER||mean score|0.5|||||TWO_SIDED|95.0|0.4|0.6|||||Represents patients reported pain score post operative week 6 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.6|0.4|
70941081|NCT03647709|141381948|OTHER||mean score|1.9|||||TWO_SIDED|95.0|1.7|2.0|||||Represents patients reported pain score post operative week 6 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||2.0|1.7|
70941082|NCT03647709|141381948|OTHER||mean score|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Represents patients reported pain score post operative week 12 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.0|-0.0|
70941083|NCT03647709|141381948|OTHER||mean score|0.2|||||TWO_SIDED|95.0|0.1|0.2|||||Represents patients reported pain score post operative week 12 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.2|0.1|
70941084|NCT03647709|141381948|OTHER||mean score|0.0|||||TWO_SIDED|95.0|0.0|0.1|||||Represents patients reported pain score post operative week 12 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.1|-0.0|
71076827|NCT00603382|141662877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106||||0.074|TWO_SIDED|95.0|-0.01|0.223|||ANCOVA|||||0.223|-0.010|0.074
70941085|NCT03647709|141381948|OTHER||mean score|0.5|||||TWO_SIDED|95.0|0.4|0.7|||||Represents patients reported pain score post operative week 12 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.7|0.4|
70941086|NCT03647709|141381951|OTHER|||||||0.0015|||||||Fisher Exact|||||||0.0015
70941087|NCT03647709|141381952|OTHER|||||||0.6398|||||||Fisher Exact|||||||.6398
70941088|NCT03647709|141381953|OTHER|||||||0.0658|||||||Fisher Exact|||||||.0658
70941089|NCT03647709|141381954|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
70941090|NCT05045638|141381955|OTHER||Ratio of GLSMs|1.6999|||||TWO_SIDED|90.0|1.186|2.4363||||||The ratios of geometric least squares means (GLSMs) and confidence intervals (CIs) were obtained by taking the exponential of the corresponding differences and CIs on the natural-log (ln) scale.||2.4363|1.1860|
70941091|NCT05045638|141381956|OTHER||Ratio of GLSMs|1.3389|||||TWO_SIDED|90.0|1.0334|1.7347||||||The ratios of GLSMs and CIs were obtained by taking the exponential of the corresponding differences and CIs on the ln scale.||1.7347|1.0334|
70941092|NCT05045638|141381957|OTHER||Ratio of GLSMs|1.3382|||||TWO_SIDED|90.0|0.9856|1.8169||||||The ratios of GLSMs and CIs were obtained by taking the exponential of the corresponding differences and CIs on the ln scale.||1.8169|0.9856|
70941093|NCT02032420|141381969|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Repeated-measures MANOVA|The reported p value is for the effect of group assignment across three iterations of the assigned task.||||||<0.001
70941094|NCT02032420|141381970|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||Repeated-measures MANOVA|The p value is for the effect of group assignment across three iterations of the assigned task.||||||0.004
70941095|NCT02032420|141381971|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.038
70941096|NCT02032420|141381972|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Fisher Exact|||||||0.003
70941097|NCT00603278|141382015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|||<|0.001|TWO_SIDED|95.0|0.096|0.318|||ANCOVA|||||0.318|0.096|<0.001
70941098|NCT00603278|141382015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238|||<|0.001|TWO_SIDED|95.0|0.127|0.349|||ANCOVA|||||0.349|0.127|<0.001
70941099|NCT00603278|141382015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.293|||<|0.001|TWO_SIDED|95.0|0.182|0.404|||ANCOVA|||||0.404|0.182|<0.001
70941100|NCT00603278|141382015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.279|||<|0.001|TWO_SIDED|95.0|0.167|0.392|||ANCOVA|||||0.392|0.167|<0.001
70941101|NCT00603278|141382015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.225|||<|0.001|TWO_SIDED|95.0|0.114|0.337|||ANCOVA|||||0.337|0.114|<0.001
71076828|NCT02993354|141662904|SUPERIORITY||Relative Rate|0.95||||0.75|TWO_SIDED|95.0|0.69|1.31|||t-test, 2 sided|||||1.31|0.69|0.75
70941102|NCT01207453|141382059|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed rank tests.||||0.42
70941103|NCT01207453|141382059|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.37
70941104|NCT01207453|141382060|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using the Wilcoxon signed-rank tests.||||0.39
70941105|NCT01207453|141382060|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.96
70941106|NCT01207453|141382061|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed-rank tests.||||0.89
70941107|NCT01207453|141382061|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.83
70941108|NCT01207453|141382062|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed-rank tests.||||0.04
70941109|NCT01207453|141382062|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.04
70941110|NCT01207453|141382063|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed-rank tests.||||0.89
70941111|NCT01207453|141382063|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.44
71076829|NCT03704948|141662925|SUPERIORITY||Mean Difference (Net)|0.82|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
71116967|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.63|||<|0.001|TWO_SIDED|95.0|2.15|3.11|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.11|2.15|<0.001
71116968|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.36|||<|0.001|TWO_SIDED|95.0|1.89|2.84|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.84|1.89|<0.001
71116969|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.17||||0.312|TWO_SIDED|95.0|-0.16|0.51|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.51|-0.16|0.312
71116970|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.02||||0.91|TWO_SIDED|95.0|-0.35|0.31|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.31|-0.35|0.910
71116971|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.27||||0.113|TWO_SIDED|95.0|-0.06|0.6|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.60|-0.06|0.113
71116972|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.48|||<|0.001|TWO_SIDED|95.0|1.98|2.97|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.97|1.98|<0.001
71116973|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.25|||<|0.001|TWO_SIDED|95.0|1.76|2.75|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.75|1.76|<0.001
71116974|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.51|||<|0.001|TWO_SIDED|95.0|2.02|3.01|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.01|2.02|<0.001
71116975|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.35|||<|0.001|TWO_SIDED|95.0|1.86|2.85|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.85|1.86|<0.001
71116976|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.12||||0.482|TWO_SIDED|95.0|-0.22|0.47|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.47|-0.22|0.482
70853747|NCT00475982|141195657|SUPERIORITY||Mean Difference (Net)|0.77||||0.835|TWO_SIDED|95.0|-6.7|8.24|||paired t-test|||analysis between the intervention and control arms||8.24|-6.70|0.835
70853748|NCT00475982|141195658|SUPERIORITY|||||||0|||||||paired t-test|||intra-analysis within the weight loss arm||||0.00
70853749|NCT00475982|141195658|SUPERIORITY|||||||0.009|||||||paired t-test|||intra-analysis within the control arm||||0.009
70853750|NCT00475982|141195658|SUPERIORITY||Mean Difference (Net)|2.11||||0.007|TWO_SIDED|95.0|0.64|3.59|||paired t-test|||analysis between the two arms||3.59|0.64|0.007
70853751|NCT00475982|141195659|SUPERIORITY|||||||0.073|||||||paired t-test|||intra-analysis within the weight loss arm||||0.073
70853752|NCT00475982|141195659|SUPERIORITY|||||||0.207|||||||paired t-test|||intra-analysis within the control arm||||0.207
70853753|NCT00475982|141195659|SUPERIORITY||Mean Difference (Net)|1.34||||0.063|TWO_SIDED|95.0|-0.08|2.75|||paired t-test|||analysis between the two arms||2.75|-0.08|0.063
70941112|NCT01207453|141382064|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed-rank tests.||||0.35
70941113|NCT01207453|141382064|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.34
70941114|NCT01207453|141382065|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed-rank tests.||||0.72
70941115|NCT01207453|141382065|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.82
71116977|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.1||||0.573|TWO_SIDED|95.0|-0.44|0.24|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.24|-0.44|0.573
71116978|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.16||||0.368|TWO_SIDED|95.0|-0.19|0.5|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.50|-0.19|0.368
71116979|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.4|||<|0.001|TWO_SIDED|95.0|1.88|2.91|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.91|1.88|<0.001
71116980|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.17|||<|0.001|TWO_SIDED|95.0|1.66|2.68|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.68|1.66|<0.001
71116981|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.44|||<|0.001|TWO_SIDED|95.0|1.93|2.96|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.96|1.93|<0.001
71116982|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.23|||<|0.001|TWO_SIDED|95.0|1.72|2.74|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.74|1.72|<0.001
71116983|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.17||||0.352|TWO_SIDED|95.0|-0.19|0.53|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.53|-0.19|0.352
71116984|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.771|TWO_SIDED|95.0|-0.41|0.3|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.30|-0.41|0.771
71116985|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.22||||0.235|TWO_SIDED|95.0|-0.14|0.58|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.58|-0.14|0.235
71116986|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.32|||<|0.001|TWO_SIDED|95.0|1.79|2.86|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.86|1.79|<0.001
71116987|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.05|||<|0.001|TWO_SIDED|95.0|1.52|2.58|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.58|1.52|<0.001
71116988|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.37|||<|0.001|TWO_SIDED|95.0|1.83|2.9|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.90|1.83|<0.001
71116989|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.2|||<|0.001|TWO_SIDED|95.0|1.66|2.73|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.73|1.66|<0.001
71116990|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.13||||0.51|TWO_SIDED|95.0|-0.25|0.5|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.50|-0.25|0.510
71116991|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.15||||0.442|TWO_SIDED|95.0|-0.52|0.23|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.23|-0.52|0.442
71116992|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.17||||0.372|TWO_SIDED|95.0|-0.2|0.54|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.54|-0.20|0.372
71116993|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.97|||<|0.001|TWO_SIDED|95.0|1.39|2.55|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.55|1.39|<0.001
70853754|NCT00783198|141195668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.76||||0.0039|TWO_SIDED|95.0|-2.95|-0.57|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.57|-2.95|0.0039
71079461|NCT00482170|141666445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.311|TWO_SIDED|95.0|0.82|1.87||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.87|0.82|0.311
70853755|NCT00783198|141195668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.24||||0.0002|TWO_SIDED|95.0|-3.41|-1.07|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-1.07|-3.41|0.0002
70941116|NCT00925288|141382074|NON_INFERIORITY_OR_EQUIVALENCE|Since the standard schedule is at (0, 2, 6 months), and the modified schedule at (0, 3, 6 months), we will consider this a non-inferiority study. With 80% power, type 1 error of 0.05, standard deviations of 0.6, and an equivalence margin of 0.3, 64 women are needed per group to detect non-inferiority. Having 100 women in each study arm will yield over 94% power to detect non-inferiority of the modified schedule.|||||>|0.2||95.0|||||Regression, Logistic|||The null hypothesis is that both schedules will provide an equivalent antibody response.||||>0.20
70941117|NCT00925288|141382075|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Chi-squared|||Completion rates compared in the 2 study arms||||0.60
70941118|NCT00925288|141382076|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Chi-squared|||comparison of differences in HPV DNA prevalence by study arm.||||0.53
70941119|NCT03322514|141382078|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
70941120|NCT03322514|141382078|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Baseline to 12 weeks||||0.04
70941121|NCT03322514|141382078|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||Baseline to 12 weeks||||0.1
70941122|NCT03322514|141382079|SUPERIORITY|||||||0.8|||||||ANOVA|||||||0.8
70941123|NCT03322514|141382079|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||Baseline to 12 weeks||||0.3
70941124|NCT03322514|141382079|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||Baseline to 12 weeks||||0.3
70941125|NCT03322514|141382080|SUPERIORITY|||||||0.9|||||||ANOVA|||||||0.9
70941126|NCT03322514|141382080|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||Baseline to 12 weeks||||0.4
70941127|NCT03322514|141382080|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||baseline to 12 weeks||||0.7
70853756|NCT00783198|141195669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09||||0.032|TWO_SIDED|95.0|-2.08|-0.09|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.09|-2.08|0.0320
70853757|NCT00783198|141195669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.0003|TWO_SIDED|95.0|-2.78|-0.82|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.82|-2.78|0.0003
70941128|NCT01184859|141382081|SUPERIORITY_OR_OTHER|||||||0.211||95.0||||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.211
70941129|NCT01184859|141382081|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.010
70941130|NCT01184859|141382081|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||<0.001
71076830|NCT01687283|141662951|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the lower limit of the two-sided 95% confidence interval for the treatment difference (FP minus BUD) in the mean change from baseline in daily AM PEF averaged over the 12 week treatment period was greater than -12 L/min.|Mean Difference (Net)|-1.8||||0.733|TWO_SIDED|95.0|-12.19|8.59||Analysis performed using ANCOVA with covariates of baseline, center, sex, age and treatment|ANCOVA||The analysis only included participants who had at least 4 days of non-missing AM PEF data in the baseline week prior to randomization and at least 4 days of non-missing AM PEF data after randomization.|||8.59|-12.19|0.733
71076831|NCT01687283|141662952|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the lower limit of the two-sided 95% confidence interval for the treatment difference (FP minus BUD) in the mean change from baseline in daily AM PEF averaged over the 12 week treatment period was greater than -12 L/min.|Mean Difference (Net)|-2.28||||0.674|TWO_SIDED|95.0|-12.95|8.38|||ANCOVA|||||8.38|-12.95|0.674
71076832|NCT01687283|141662953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.77||||0.579|TWO_SIDED|95.0|-12.57|7.04|||ANCOVA|||||7.04|-12.57|0.579
71076833|NCT01687283|141662954|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.62||||0.854|TWO_SIDED|95.0|-6.0|7.24|||ANCOVA|||||7.24|-6.00|0.854
71076834|NCT01687283|141662955|SUPERIORITY_OR_OTHER|||||||0.123|||||||Wilcoxon rank sum test|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in median day-time symptom score||||0.123
71076835|NCT01687283|141662955|SUPERIORITY_OR_OTHER|||||||0.949|||||||Wilcoxon rank sum test.|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in median night-time symptom score||||0.949
70941131|NCT01184859|141382081|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||<0.001
70941132|NCT01184859|141382082|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.272||||0.194|TWO_SIDED|95.0|-0.685|-0.141||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|ANCOVA|Gender is a factor, and duration of action and baseline number of nocturnal voids are covariates.||||-0.141|-0.685|0.194
70941133|NCT01184859|141382082|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.547||||0.015|TWO_SIDED|95.0|-0.985|-0.108||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|ANCOVA|Gender is a factor, and duration of action and baseline number of nocturnal voids are covariates.||||-0.108|-0.985|0.015
70941134|NCT01184859|141382082|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.854|||<|0.001|TWO_SIDED|95.0|-1.317|-0.391||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|ANCOVA|Gender is a factor, and duration of action and baseline number of nocturnal voids are covariates.||||-0.391|-1.317|<0.001
70941135|NCT01184859|141382082|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.888||||0.001|TWO_SIDED|95.0|-1.426|-0.351||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|ANCOVA|Gender is a factor, and duration of action and baseline number of nocturnal voids are covariates.||||-0.351|-1.426|0.001
70941136|NCT01537120|141382115|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.91|||||TWO_SIDED|90.0|0.85|0.96||||||||0.96|0.85|
70941137|NCT01537120|141382116|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.3|||||TWO_SIDED|90.0|-0.36|-0.23||||||||-0.23|-0.36|
70941138|NCT01537120|141382117|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.46|||||TWO_SIDED|90.0|-0.62|-0.3||||||||-0.30|-0.62|
71076836|NCT01687283|141662956|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.74||||0.204|TWO_SIDED|95.0|-12.07|2.59|||ANCOVA|||||2.59|-12.07|0.204
71076837|NCT01687283|141662957|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Wilcoxon Rank sum|||||||0.170
71076838|NCT01687283|141662958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.039||||0.337|TWO_SIDED|95.0|-0.118|0.041||Repeated Measures analysis adjusted for baseline, centre, sex, age, visit, treatment, visit by treatment interaction and visit by baseline interaction|ANCOVA|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in Change of clinical lung function measurement FEV1 at Week 2||0.041|-0.118|0.337
71076839|NCT01687283|141662958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.008||||0.866|TWO_SIDED|95.0|-0.101|0.085||Repeated Measures analysis adjusted for baseline, center, sex, age, visit, treatment, visit by treatment interaction and visit by baseline interaction.|ANCOVA|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in Change of clinical lung function measurement FEV1 at Week 4||0.085|-0.101|0.866
71076840|NCT01687283|141662958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.025||||0.566|TWO_SIDED|95.0|-0.113|0.062||Repeated Measures analysis adjusted for baseline, center, sex, age, visit, treatment, visit by treatment interaction and visit by baseline interaction|ANCOVA|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in Change of clinical lung function measurement FEV1 at Week 8||0.062|-0.113|0.566
71076841|NCT01687283|141662958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.017||||0.727|TWO_SIDED|95.0|-0.078|0.112||Repeated Measures analysis adjusted for baseline, center, sex, age, visit, treatment, visit by treatment interaction and visit by baseline interaction.|ANCOVA|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in Change of clinical lung function measurement FEV1 at Week 12||0.112|-0.078|0.727
71076842|NCT01663857|141662966|SUPERIORITY|||||||0.4|||||||Log Rank|||||||0.4
71076843|NCT01663857|141662968|SUPERIORITY|||||||0.4686|||||||Log Rank|||||||0.4686
71076844|NCT03041467|141662971|SUPERIORITY||||||<|0.001|||||||One-sided Z-test|||||||<0.001
71076845|NCT03041467|141662972|NON_INFERIORITY|Non-inferiority p-values for the primary safety endpoint was based on the Farrington-Manning non-inferiority test with a margin of 7.5%.||||||0.002|||||||Farrington-Manning Test|||||||0.002
71076846|NCT03041467|141662973|SUPERIORITY||||||<|0.001||||||There is no planned hypothesis test other than at 6 months time point. P-value listed is at 6 months.|Log Rank|||Kaplan-Meier method was used to estimate access circuit primary patency.||||<0.001
71076847|NCT03041467|141662974|OTHER|There is no planned hypothesis test other than at 6 months time point. P-value listed is at 6 months.|||||<|0.001||||||There is no planned hypothesis test other than at 6 months time point. P-value listed is at 6 months. Survival analysis was performed using Kaplan-Meier method.|Log Rank|||Kaplan-Meier method was used to estimate target lesion primary patency.|Survival analysis was performed using Kaplan-Meier method.|||<0.001
71076848|NCT03041467|141662975|SUPERIORITY||||||<|0.001||||||There is no planned hypothesis test other than at 6 months time point. P-value listed is at 6 months.|Chi-squared|||||||<0.001
71076849|NCT03041467|141662979|SUPERIORITY||||||>|0.999|||||||Chi-squared|||||||>0.999
71076850|NCT03041467|141662980|SUPERIORITY|||||||0.482|||||||Chi-squared|||||||0.482
71076851|NCT03041467|141662981|SUPERIORITY||||||>|0.999|||||||Chi-squared|||||||>0.999
71076852|NCT03052920|141662991|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<=0.05|t-test, 2 sided|t(35) = 11.29||Mean difference in percent correct for CNC words at 6 months post-implant and pre-implant is reported.||||<0.001
71076853|NCT03052920|141662992|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<=0.05|t-test, 2 sided|t(35) = 16.947||Mean difference in Soundfield thresholds (averaged across the frequency range in dB HL) at 6 months post-implant and pre-implant is reported.||||<0.001
71076854|NCT03052920|141662993|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was \<= 0.05|t-test, 2 sided|t(35) = 2.14||Mean difference in degrees RMS error at 6 months post-implant and pre-implant is reported.||||<0.05
71076855|NCT03052920|141662994|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(35) = 4.02||Mean difference in percentage of understanding (words correct) at 6 months post-implant and pre-implant is reported.||||<0.001
71076856|NCT03052920|141662995|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(35) = 2.58||Mean difference in AzBio sentence scores in noise at 6 months post-implant and pre-implant is reported.||||<0.05
71076857|NCT03052920|141662996|SUPERIORITY||||||<|0.01||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(35) = 3.16||Mean difference in dB SNR for BKB-SIN sentences with noise to the better ear at 6-months post-implant and pre-implant is reported.||||<0.01
71076858|NCT03052920|141662997|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(35) = 10.42||Mean difference in AzBio sentence scores at 60 dB SPL for the poor ear alone at 6 months post-implant and pre-implant is reported.||||<0.001
71076859|NCT03052920|141662998|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(38) = 7.15||Mean difference in HHIE reported scores at 6-months post-implant and pre-implant is reported.||||<0.001
71076860|NCT03052920|141662999|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(38) = 4.34||Mean difference in HUI3 ratings at 6 months post-implant and pre-implant is reported.||||<0.001
71076861|NCT03052920|141663000|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(38) = 7.71||Mean difference in ratings for the SSQ total score at 6 months post-implant and pre-implant is reported.||||<0.001
71076862|NCT03052920|141663001|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(38) = 7.90||Mean difference in SSQ ratings at 12 months post-implant and pre-implant is reported.||||<0.001
71076863|NCT03052920|141663002|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(38) = 2.31||Mean difference in SADL scores at 6 months post-implant and pre-implant are reported.||||<0.05
71076864|NCT03052920|141663003|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(25) = 7.27||Mean difference in the CPHI scores at 6 months post-implant and pre-implant are reported.||||<0.001
71076865|NCT03052920|141663004|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(25) = 7.65||Mean difference in HII-SOP scores at 6 months post-implant and pre-implant is reported.||||<0.001
71076866|NCT03052920|141663005|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(35) = 2.34||Mean difference in the dB SNR scores for BKB-SIN sentences at 6 months post-implant minus pre-implant is reported.||||<0.05
71076867|NCT00564278|141663008|SUPERIORITY_OR_OTHER_LEGACY||GEE model Beta|17.46||||0.26|TWO_SIDED|95.0|-16.61|51.53||All analyses presented are at 9 months.|t-test, 2 sided|t(193) = -1.14, p=.26||"We also conducted an analysis using a Generalized Estimating Equations model adjusting for a number of covariates.~We will conduct a three-part regression analysis assessing early/middle/late effects of MPT on retention. We will also conduct moderator analyses, as described in the original study grant, to determine whether there are specific patient groups for whom a significant difference in days in treatment is found."||51.53|-16.61|0.26
71076868|NCT00564278|141663009|SUPERIORITY_OR_OTHER_LEGACY||Mixed Model Beta for MADT vs SADT|-0.28|||||TWO_SIDED|95.0|-1.57|1.01||See Method of Estimation below.|||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline depressive symptoms and time to assess the effect of MADT vs. SADT on mean depressive symptoms over follow-up.|||1.01|-1.57|
71076869|NCT00564278|141663010|SUPERIORITY_OR_OTHER_LEGACY||Work - Mixed Model Beta for MADT vs SADT|0.22|||||TWO_SIDED|95.0|-0.5|0.95||See under Method of Estimation, below|||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline work-related disability score and time to assess the effect of MADT vs. SADT on mean disability score in the work domain over follow-up.|||0.95|-0.50|
71076870|NCT00564278|141663010|SUPERIORITY_OR_OTHER_LEGACY||Social-Mixed Model Beta for MADT vs SADT|0.22|||||TWO_SIDED|95.0|-0.49|0.92||See under Method of Estimation below.|||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline social-related disability score and time to assess the effect of MADT vs. SADT on mean disability score in the social domain over follow-up.|||0.92|-0.49|
71076871|NCT00564278|141663010|SUPERIORITY_OR_OTHER_LEGACY||Family-Mixed Model Beta for MADT vs SADT|0.55|||||TWO_SIDED|95.0|-0.08|1.18||See Method of Estimation below.|||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline family-related disability score and time to assess the effect of MADT vs. SADT on mean disability score in the family domain over follow-up.|||1.18|-0.08|
71076872|NCT00564278|141663011|SUPERIORITY_OR_OTHER_LEGACY||Mixed Model Beta for MADT vs SADT|0.02|||||TWO_SIDED|95.0|-3.61|3.64||See Method of Estimation, below|||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline QOL score and time to assess the effect of MADT vs. SADT on mean percent of quality of life over follow-up.|||3.64|-3.61|
71076873|NCT00564278|141663012|SUPERIORITY_OR_OTHER_LEGACY||Mixed Model Beta for MADT vs SADT|-0.04|||||TWO_SIDED|95.0|-0.74|0.66||See Method of Estimation below.|||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline patient satisfaction and time to assess the effect of MADT vs. SADT on mean patient satisfaction over follow-up.|||0.66|-0.74|
71076874|NCT00564278|141663013|SUPERIORITY_OR_OTHER_LEGACY||Mixed Model Beta for MADT vs SADT|9.14|||||TWO_SIDED|95.0|2.71|15.57||See Method of Estimation below.|||A Generalized Linear Mixed Model was used with random intercept for clinician to model the effect of MPT vs. SADT on the mean proportion of fully adherent days over the study period. We used an exchangeable covariance structure.|||15.57|2.71|
70941139|NCT02123797|141382155|SUPERIORITY||Odds Ratio (OR)|2.03||||0.0007|TWO_SIDED|95.0|1.35|3.06||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without invasive stage confirmation (numerator=108/70) to Serial Care patients with and without invasive stage confirmation (denominator=168/180) after adjustment for matched study.|||3.06|1.35|0.0007
71076875|NCT02368886|141663020|SUPERIORITY||Risk Difference (RD)|0.17||||0.0434|TWO_SIDED|95.0|0.0|0.34||1-sided|Fisher Exact|||||0.34|0.00|0.0434
71076876|NCT02368886|141663021|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.1241|TWO_SIDED|95.0|0.47|1.1|||Log Rank|||||1.10|0.47|0.1241
71076877|NCT02368886|141663022|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.3797|TWO_SIDED|95.0|0.57|1.24|||Log Rank|||||1.24|0.57|0.3797
71076878|NCT02368886|141663023|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.4614|TWO_SIDED|95.0|0.55|1.31|||Log Rank|||||1.31|0.55|0.4614
71076879|NCT02368886|141663028|SUPERIORITY|||||||0.7319|||||||Kruskal-Wallis|||||||0.7319
70853758|NCT00783198|141195670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.0472|TWO_SIDED|95.0|-1.54|-0.01|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.01|-1.54|0.0472
71076880|NCT04997265|141663063|OTHER|Given the small sample size, simple descriptive were used. Between-group differences were performed using a Fisher exact test.|||||<|0.05|||||||Fisher Exact|||||||<0.05
71076881|NCT04847232|141663077|OTHER|Test of HR = 1|Hazard Ratio (HR)|0.98||||0.867|TWO_SIDED|95.0|0.76|1.26|||Regression, Cox||SZC relative to Placebo|||1.26|0.76|0.867
71076882|NCT04847232|141663078|OTHER|Test of OR = 1|Odds Ratio (OR)|3.36|||<|0.0001|TWO_SIDED|95.0|2.64|4.26|||Regression, Logistic||SZC relative to Placebo|||4.26|2.64|<.0001
71076883|NCT04847232|141663079|OTHER|Test of HR = 1|Hazard Ratio (HR)|1.12||||0.51|TWO_SIDED|95.0|0.8|1.56|||Regression, Cox||SZC relative to Placebo|||1.56|0.80|0.510
71076884|NCT02290925|141663091|OTHER|general linear model (GLM) with repeated measures|Mean Difference (Net)|0.25|||||TWO_SIDED||||||||Box's M tests was used. Mauchly's test was used to verify that the error covariance matrix of the orthonormalized-transformed dependent variables is proportional to an identity matrix.||"We used intention to treat analysis. Since the missing data were more than 5%, we examined the dataset to determine whether it shows missing completely at random (MCAR) not missing at random (NMAR) or data missing at random (MAR). A sensitivity analysis was done to determine whether multiple imputations are required. It included complete case analysis, best-worst case and worst best case scenario with group mean±1SD."|||
71076885|NCT01716520|141663095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|||<|0.001|TWO_SIDED|95.0|0.085|0.157||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to UMEC=responders to UMEC or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 milliliters (mL) at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.157|0.085|<0.001
71116994|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.82|||<|0.001|TWO_SIDED|95.0|1.25|2.4|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.40|1.25|<0.001
71076886|NCT01716520|141663095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|||<|0.001|TWO_SIDED|95.0|0.1|0.171||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to UMEC=responders to UMEC or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 mL at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.171|0.100|<0.001
71116995|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.15|||<|0.001|TWO_SIDED|95.0|1.57|2.72|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.72|1.57|<0.001
71116996|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.87|||<|0.001|TWO_SIDED|95.0|1.3|2.45|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.45|1.30|<0.001
71116997|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.1||||0.639|TWO_SIDED|95.0|-0.31|0.5|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.50|-0.31|0.639
71116998|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.803|TWO_SIDED|95.0|-0.45|0.35|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.35|-0.45|0.803
71116999|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.27||||0.184|TWO_SIDED|95.0|-0.13|0.67|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.67|-0.13|0.184
71117000|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.67|||<|0.001|TWO_SIDED|95.0|1.07|2.26|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.26|1.07|<0.001
71117001|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.58|||<|0.001|TWO_SIDED|95.0|0.99|2.17|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.17|0.99|<0.001
71117002|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.84|||<|0.001|TWO_SIDED|95.0|1.25|2.43|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.43|1.25|<0.001
71117003|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.69|||<|0.001|TWO_SIDED|95.0|1.1|2.28|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.28|1.10|<0.001
71117004|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.02||||0.91|TWO_SIDED|95.0|-0.44|0.39|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.39|-0.44|0.910
71117005|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.11||||0.607|TWO_SIDED|95.0|-0.52|0.3|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.30|-0.52|0.607
71117006|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.15||||0.484|TWO_SIDED|95.0|-0.27|0.56|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.56|-0.27|0.484
71117007|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.25|||<|0.001|TWO_SIDED|95.0|0.64|1.86|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.86|0.64|<0.001
71117008|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.36|||<|0.001|TWO_SIDED|95.0|0.75|1.97|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.97|0.75|<0.001
71117009|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.38|||<|0.001|TWO_SIDED|95.0|0.77|1.99|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.99|0.77|<0.001
71117010|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.5|||<|0.001|TWO_SIDED|95.0|0.89|2.1|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.10|0.89|<0.001
71117011|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.25||||0.256|TWO_SIDED|95.0|-0.67|0.18|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.18|-0.67|0.256
71117012|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.14||||0.526|TWO_SIDED|95.0|-0.56|0.29|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.29|-0.56|0.526
70941140|NCT02123797|141382156|SUPERIORITY||Odds Ratio (OR)|1.87||||0.0022|TWO_SIDED|95.0|1.25|2.8||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without invasive mediastinal staging (numerator=91/87) to Serial Care patients with and without mediastinal invasive staging (denominator=126/222) after adjustment for matched study.|||2.80|1.25|0.0022
71076887|NCT01716520|141663095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|||<|0.001|TWO_SIDED|95.0|0.11|0.174||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to VI=responders to VI or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 mL at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.174|0.110|<0.001
70941141|NCT02123797|141382157|SUPERIORITY||Odds Ratio (OR)|3.12||||0.0004|TWO_SIDED|95.0|1.67|5.85||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without bi-modal staging (numerator=161/17) to Serial Care patients with and without bi-modal staging (denominator=267/81) after adjustment for matched study design.|||5.85|1.67|0.0004
71076888|NCT01716520|141663095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|||<|0.001|TWO_SIDED|95.0|0.067|0.13||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to VI=responders to VI or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 mL at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.130|0.067|<0.001
71076889|NCT01716520|141663095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052||||0.047|TWO_SIDED|95.0|0.001|0.104||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to Neither=responders to neither UMEC nor VI, as defined by a participant with at least one FEV1 assessment over 0-6 hours post-dose on Day 1 but no increase from Baseline of \>=12% and 200 mL at any assessment(s).|||0.104|0.001|0.047
71117013|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.11||||0.602|TWO_SIDED|95.0|-0.54|0.31|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.31|-0.54|0.602
71117014|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.95||||0.002|TWO_SIDED|95.0|0.34|1.56|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.56|0.34|0.002
71117015|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.98||||0.001|TWO_SIDED|95.0|0.38|1.59|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.59|0.38|0.001
71117016|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.25|||<|0.001|TWO_SIDED|95.0|0.65|1.86|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.86|0.65|<0.001
71117017|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.22|||<|0.001|TWO_SIDED|95.0|0.61|1.82|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.82|0.61|<0.001
71117018|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.26||||0.224|TWO_SIDED|95.0|-0.69|0.16|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.16|-0.69|0.224
70853759|NCT00783198|141195670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94||||0.0144|TWO_SIDED|95.0|-1.7|-0.19|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.19|-1.70|0.0144
70853760|NCT00783198|141195671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.1686|TWO_SIDED|95.0|-1.11|0.19|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.19|-1.11|0.1686
70853761|NCT00783198|141195671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.0125|TWO_SIDED|95.0|-1.46|-0.18|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.18|-1.46|0.0125
70853762|NCT00783198|141195672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98||||0.0039|TWO_SIDED|95.0|-1.65|-0.32|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.32|-1.65|0.0039
70853763|NCT00783198|141195672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.0001|TWO_SIDED|95.0|-1.95|-0.64|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.64|-1.95|0.0001
70853764|NCT04345367|141195674|SUPERIORITY||Estimate of difference|22.6|||<|0.0001|TWO_SIDED|95.0|15.8|29.5||Cochran-Mantel-Haenszel (CMH) method adjusted by baseline disease severity.|Cochran-Mantel-Haenszel||The estimate and confidence interval (CI) for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||29.5|15.8|<0.0001
70941142|NCT02123797|141382158|SUPERIORITY||Odds Ratio (OR)|2.25|||<|0.0001|TWO_SIDED|95.0|1.5|3.36||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without tri-modal staging (numerator=99/79) to Serial Care patients with and without tri-modal staging (denominator=132/216) after adjustment for matched study design.|||3.36|1.50|<0.0001
71076890|NCT01716520|141663095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073||||0.006|TWO_SIDED|95.0|0.021|0.124||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to Neither=responders to neither UMEC nor VI, as defined by a participant with at least one FEV1 assessment over 0-6 hours post-dose on Day 1 but no increase from Baseline of \>=12% and 200 mL at any assessment(s).|||0.124|0.021|0.006
71076891|NCT05460078|141663107|SUPERIORITY||Odds Ratio (OR)|1.39|||<|0.001|TWO_SIDED|95.0|1.16|1.68|||Mixed Models Analysis|||||1.68|1.16|<0.001
71076892|NCT05460078|141663108|SUPERIORITY||Odds Ratio (OR)|1.39|||<|0.001|TWO_SIDED|95.0|1.18|1.65|||Mixed Models Analysis|||||1.65|1.18|<0.001
71076893|NCT05460078|141663109|SUPERIORITY||Odds Ratio (OR)|1.96|||<|0.001|TWO_SIDED|95.0|1.54|2.48|||Mixed Models Analysis|||||2.48|1.54|<0.001
70853765|NCT04345367|141195675|SUPERIORITY||Estimate of difference|14.1|||<|0.0001|TWO_SIDED|95.0|8.2|20.0||CMH method adjusted by baseline disease severity.|Cochran-Mantel-Haenszel||The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||20.0|8.2|<0.0001
70853766|NCT04345367|141195676|SUPERIORITY||Estimate of difference|12.5||||0.0008|TWO_SIDED|95.0|5.3|19.7||CMH method adjusted by baseline disease severity.|Cochran-Mantel-Haenszel||The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||19.7|5.3|0.0008
70853767|NCT04345367|141195677|OTHER||Estimate of difference|4.5|||||TWO_SIDED|95.0|0.2|8.7|||||Week 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||8.7|0.2|
70853768|NCT04345367|141195677|OTHER||Estimate of difference|20.0|||||TWO_SIDED|95.0|13.2|26.9|||||Week 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||26.9|13.2|
70853769|NCT04345367|141195677|OTHER||Estimate of difference|14.0|||||TWO_SIDED|95.0|6.9|21.1|||||Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||21.1|6.9|
70853770|NCT04345367|141195677|OTHER||Estimate of difference|12.7|||||TWO_SIDED|95.0|5.5|20.0|||||Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||20.0|5.5|
70853771|NCT04345367|141195677|OTHER||Estimate of difference|6.9|||||TWO_SIDED|95.0|-0.4|14.3|||||Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||14.3|-0.4|
70853772|NCT04345367|141195678|OTHER||Estimate of difference|8.1|||||TWO_SIDED|95.0|1.8|14.4|||||Week 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||14.4|1.8|
70853773|NCT04345367|141195678|OTHER||Estimate of difference|20.9|||||TWO_SIDED|95.0|13.8|28.0|||||Week 4. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||28.0|13.8|
70853774|NCT04345367|141195678|OTHER||Estimate of difference|18.4|||||TWO_SIDED|95.0|11.4|25.3|||||Week 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||25.3|11.4|
70853775|NCT04345367|141195678|OTHER||Estimate of difference|14.9|||||TWO_SIDED|95.0|8.2|21.5|||||Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||21.5|8.2|
70853776|NCT04345367|141195678|OTHER||Estimate of difference|9.5|||||TWO_SIDED|95.0|3.0|16.0|||||Week 16. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||16.0|3.0|
71076894|NCT05460078|141663110|SUPERIORITY||Odds Ratio (OR)|1.4|||<|0.001|TWO_SIDED|95.0|1.17|1.66|||Mixed Models Analysis|||||1.66|1.17|<0.001
71076895|NCT00592592|141663140|OTHER||Cumulative incidence|10.9|||||TWO_SIDED|95.0|5.7|18.0||||||||18.0|5.7|
71076896|NCT00592592|141663142|OTHER||% hypothalamus normal tissue spared|88.0|||<|0.01|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||<0.01
71076897|NCT00592592|141663142|OTHER||% pituitary normal tissue spared|73.0|||<|0.01|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||<0.01
71076898|NCT00592592|141663142|OTHER||% lens (contra) normal tissue spared|100.0|||<|0.01|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||<0.01
71076899|NCT00592592|141663142|OTHER||% maxilla normal tissue spared|42.0||||0.02|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.02
71076900|NCT00592592|141663143|OTHER||Percent Survival, Local Control|80.9|||||TWO_SIDED|95.0|73.0|87.7||||||||87.7|73.0|
71076901|NCT02005627|141663173|SUPERIORITY||||||<|0.05||||||calculated|t-test, 2 sided|||||||<0.05
71076902|NCT02005627|141663176|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71076903|NCT02005627|141663177|SUPERIORITY|||||||||||||||||Null Hypothesis was no difference between Grazax and Placebo treatment at 12 months. 80% power to detect 30% difference in total nasal symptom score (TNSS) after nasal challenge|Comparison of nasal symptom score at 0-60 mins after nasal challenge after 12 months treatment with Grazax compared to Placebo treatment. Mixed model analysis. 80% power to detect a 30% difference at p\<0.05.|||
71076904|NCT04000360|141663178|SUPERIORITY||Difference in slopes.|-3.62|STANDARD_ERROR_OF_MEAN|0.91|<|0.0001|TWO_SIDED|95.0|-5.4|-1.85||This was the sole primary outcome. The test was conducted with a priori p-value threshold of α=0.05, with no multiple comparison adjustment.|Mixed Models Analysis|Test of equality of slopes with time (change in points/year) between aerobic exercise (AE) and usual and customary care (UCC) treatment arms.|Higher MDS-UPDRS III score reflects worse Parkinson's symptoms; increases reflect PD progression. The reported effect is the estimated difference between annual rates of change in scores of AE and UCC patients.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and AR(1) covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX.||-1.85|-5.40|<0.0001
71076905|NCT04000360|141663179|SUPERIORITY|Equality of annual slopes in squared 10 Meter Walk Test Comfortable Pace Velocity for the AE and UCC groups.|Difference in squared velocity slopes|12.07|STANDARD_ERROR_OF_MEAN|4.65||0.043|TWO_SIDED|95.0|3.1|21.32||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other motor domain secondary outcomes: 10 Meter Walk Test fast pace velocity, TUG duration \& turning velocity, Manual Dexterity Test.|Mixed Models Analysis||The reported effect is the difference in annual slope of meters\^2/second, in 100ths of meters\^2/second/year. The confidence interval is not multiple comparison adjusted. Parkinson's progression limits mobility; higher slope reflects less progression.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. To reduce skew and better meet modeling assumptions, test velocity was squared ((meters/second)\^2) for modeling. Study sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||21.32|3.10|0.043
71076906|NCT04000360|141663180|SUPERIORITY|Equality of annual slopes in 10 Meter Walk Test Fast Pace Velocity for the AE and UCC groups.|Difference in slopes|3.16|STANDARD_ERROR_OF_MEAN|2.68||0.48|TWO_SIDED|95.0|-2.1|8.42||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other motor domain secondary outcomes: 10 meter walk test comfortable pace, Timed Up and Go Test duration and turning velocity, Manual Dexterity Test.|Mixed Models Analysis||The reported effect is the difference in annual slopes of the AE and UCC treatment arms, in 100ths of meters/second/year. The confidence interval is not multiple comparison adjusted. Higher slope reflects less Parkinson's disease progression.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and heterogeneous compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX.||8.42|-2.10|0.48
71076907|NCT04000360|141663181|SUPERIORITY|Equality of annual slopes of inverse Timed Up and Go Test duration, i.e., of TUG completions/second, the speed of completing the test.|Difference in slopes|4.04|STANDARD_ERROR_OF_MEAN|1.96||0.16|TWO_SIDED|95.0|0.2|7.89||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other motor domain secondary outcomes: 10 meter walk test comfortable \& fast pace, Timed Up and Go Test turning velocity, and Manual Dexterity Test.|Mixed Models Analysis|Difference between estimated annual slopes in TUG completions/second/year for the AE and UCC groups.|Timed Up and Go test speed is expected to decline with Parkinson's progression. The reported effect is the difference between estimated annual slopes for the AE and UCC groups in 1000ths of a TUG completion/second/year.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. To reduce skew and better meet modeling assumptions, test duration was inverted to TUG completions/second. Sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||7.89|0.20|0.16
71117019|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.23||||0.283|TWO_SIDED|95.0|-0.65|0.19|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.19|-0.65|0.283
71117020|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.04||||0.86|TWO_SIDED|95.0|-0.39|0.46|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.46|-0.39|0.860
71117021|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.63||||0.038|TWO_SIDED|95.0|0.03|1.22|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.22|0.03|0.038
71117022|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.65||||0.031|TWO_SIDED|95.0|0.06|1.24|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.24|0.06|0.031
71117023|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.03|||<|0.001|TWO_SIDED|95.0|0.43|1.62|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.62|0.43|<0.001
71117024|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.95||||0.002|TWO_SIDED|95.0|0.36|1.54|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.54|0.36|0.002
71117025|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.32||||0.129|TWO_SIDED|95.0|-0.74|0.09|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.09|-0.74|0.129
71117026|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.3||||0.154|TWO_SIDED|95.0|-0.71|0.11|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.11|-0.71|0.154
71117027|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.08||||0.714|TWO_SIDED|95.0|-0.34|0.49|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.49|-0.34|0.714
71117028|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.37||||0.217|TWO_SIDED|95.0|-0.22|0.96|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.96|-0.22|0.217
71117029|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.45||||0.136|TWO_SIDED|95.0|-0.14|1.03|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.03|-0.14|0.136
71117030|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.78||||0.01|TWO_SIDED|95.0|0.19|1.37|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.37|0.19|0.010
71117031|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.83||||0.006|TWO_SIDED|95.0|0.24|1.41|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.41|0.24|0.006
71117032|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.45||||0.031|TWO_SIDED|95.0|-0.87|-0.04|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||-0.04|-0.87|0.031
71117033|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.38||||0.07|TWO_SIDED|95.0|-0.79|0.03|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.03|-0.79|0.070
71117034|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.822|TWO_SIDED|95.0|-0.46|0.37|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.37|-0.46|0.822
71117035|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.28||||0.327|TWO_SIDED|95.0|-0.28|0.83|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.83|-0.28|0.327
71117036|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.34||||0.224|TWO_SIDED|95.0|-0.21|0.89|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.89|-0.21|0.224
71117037|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.63||||0.025|TWO_SIDED|95.0|0.08|1.19|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.19|0.08|0.025
71117038|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.7||||0.012|TWO_SIDED|95.0|0.15|1.25|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.25|0.15|0.012
71117039|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.43||||0.03|TWO_SIDED|95.0|-0.81|-0.04|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||-0.04|-0.81|0.030
71117040|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.36||||0.064|TWO_SIDED|95.0|-0.75|0.02|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.02|-0.75|0.064
71117041|NCT01559259|141740579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.07||||0.721|TWO_SIDED|95.0|-0.46|0.32|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.32|-0.46|0.721
71117042|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.22||||0.033|TWO_SIDED|95.0|0.02|0.42|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.42|0.02|0.033
71076908|NCT04000360|141663182|SUPERIORITY|Test of equality of average turning velocities.|Difference in slopes.|1.85|STANDARD_ERROR_OF_MEAN|1.54||0.69|TWO_SIDED|95.0|-1.17|4.88||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other motor domain secondary outcomes: 10 meter walk test comfortable \& fast pace, Timed Up and Go Test duration, and Manual Dexterity Test.|Mixed Models Analysis||Timed Up and Go test speed is expected to decline with Parkinson's progression. The reported effect is the difference between estimated annual slopes of average turning velocity for the AE and UCC groups in degrees/second/year.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. Study sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||4.88|-1.17|0.69
70853777|NCT04345367|141195678|OTHER||Estimate of difference|5.0|||||TWO_SIDED|95.0|-1.4|11.5|||||Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.5|-1.4|
71076909|NCT04000360|141663183|SUPERIORITY|Test of equality of slopes of test performance speed (peg transfers/second/year) for AE and UCC groups.|Difference in slopes.|-3.62|STANDARD_ERROR_OF_MEAN|10.23||0.72|TWO_SIDED|95.0|-23.68|16.45||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other motor domain secondary outcomes: Timed Up and Go Test (TUG) duration \& turning velocity and 10 meter walk test comfortable \& fast pace.|Mixed Models Analysis||Manual dexterity expressed as peg transfers/second is expected to decline with Parkinson's progression. The reported effect is the difference between estimated annual slopes for the AE and UCC groups in 1000ths of a peg transfer/second/year.|Linear mixed model for baseline, 6 and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. To reduce skew and better meet modeling assumptions, test duration was transformed for modeling to peg transfers/second (18/seconds). Sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||16.45|-23.68|0.72
71076910|NCT04000360|141663184|SUPERIORITY|Test of equality of slopes of squared match scores (matches\^2/year) between AE and UCC groups.|Difference in slopes.|-96.91|STANDARD_ERROR_OF_MEAN|69.12||0.48|TWO_SIDED|95.0|-232.41|38.6||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other non-motor domain secondary outcomes: Visual Memory Test and Trail Making Test B to A duration ratio.|Mixed Models Analysis||Processing speed is expected to decline with Parkinson's, hence duration of the test to increase. The reported effect is the difference in annual slopes (matches\^2/year) between the AE and UCC treatment arms.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and heterogeneous compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. To reduce skew and better meet modeling assumptions, test duration was squared (matches\^2) for analysis. Study sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||38.60|-232.41|0.48
71076911|NCT04000360|141663185|SUPERIORITY|Test of equality of annual slopes of log(TMT B to TMT A duration ratio) for AE and UCC groups.|Difference in slopes|-3.42|STANDARD_ERROR_OF_MEAN|6.06||1|TWO_SIDED|95.0|-15.31|8.46||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other non-motor domain secondary outcomes: Processing Speed Test and Visual Memory Test.|Mixed Models Analysis||Visual attention and set switching speed decline with Parkinson's, hence duration of Trail Making Test B increases. The reported effect is the difference in annual slopes of (log TMT B/TMT A), i.e., change/year, between AE and UCC treatment arms.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. To reduce skew and better meet modeling assumptions, the ratios were transformed to their natural logarithms for modeling. Study sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||8.46|-15.31|1.00
71076912|NCT04000360|141663186|SUPERIORITY|Test of equality of annual slopes of squared test score.|Difference in slopes|0.16|STANDARD_ERROR_OF_MEAN|1.4||0.91|TWO_SIDED|95.0|-2.58|2.91||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other non-motor domain secondary outcomes: Processing Speed Test and Trail Making Test Ratio.|Mixed Models Analysis||Visual memory declines with Parkinson's, hence the score declines. The reported effect is the difference in annual slopes, i.e., changes in mean score\^2/year, for AE and UCC treatment arms, shown in hundreds. Higher slope indicates slower decline.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. To reduce skew and better meet modeling assumptions, the score was squared for statistical modeling. Sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||2.91|-2.58|0.91
71117043|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.13||||0.224|TWO_SIDED|95.0|-0.08|0.33|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.33|-0.08|0.224
71117044|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.23||||0.024|TWO_SIDED|95.0|0.03|0.44|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.44|0.03|0.024
71117045|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.07||||0.501|TWO_SIDED|95.0|-0.13|0.27|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.27|-0.13|0.501
71117046|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.15||||0.036|TWO_SIDED|95.0|0.01|0.29|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.29|0.01|0.036
71076913|NCT01693185|141663187|SUPERIORITY_OR_OTHER||||||<|0.001||||||We wished to be able to distinguish a difference of 7.5 min,|Wilcoxon (Mann-Whitney)|||Recovery time in patients administered remifentanil alone will be significantly shorter than that in patients administered midazolam-meperidine combination for colonoscopy.||||< 0.001
71076914|NCT03782974|141663245|SUPERIORITY||Least Square Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.104|<|0.0001|TWO_SIDED|95.0|-0.77|-0.37||The threshold for statistical significance was p=0.05|Mixed Models Analysis|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||-0.37|-0.77|<0.0001
71076915|NCT03782974|141663246|SUPERIORITY||Risk Difference (RD)|0.27|||<|0.0001|TWO_SIDED|95.0|0.1|0.59||The threshold for statistical significance was p=0.05.|Chi-squared|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||0.59|0.10|<0.0001
71076916|NCT03782974|141663247|SUPERIORITY||Least Square Mean Difference|6.35|||<|0.001|TWO_SIDED|95.0|3.93|8.77||The threshold for statistical significance was p=0.05.|Mixed Models Analysis|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||8.77|3.93|<0.001
71076917|NCT03782974|141663248|SUPERIORITY||Least Square Mean Difference|4.049|||<|0.05|TWO_SIDED|95.0|1.08|7.01||The threshold for statistical significance was p=0.05.|Mixed Models Analysis|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||7.01|1.08|<0.05
71076918|NCT03782974|141663249|SUPERIORITY|||||||0.6||||||The threshold for statistical significance was p=0.05.|ANOVA|||||||0.6
71076919|NCT03782974|141663250|SUPERIORITY|||||||0.054||||||The threshold for statistical significance was p=0.05.|Mixed Models Analysis|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||||0.054
71076920|NCT03782974|141663251|SUPERIORITY|||||||0.13||||||The threshold for statistical significance was p=0.05.|Mixed Models Analysis|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||||0.13
71076921|NCT03782974|141663252|SUPERIORITY||Least Square Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.102|<|0.0001|TWO_SIDED|95.0|-0.96|-0.56||The threshold for statistical significance was p=0.05.|Mixed Models Analysis|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||-0.56|-0.96|<0.0001
71076922|NCT01783821|141663253|SUPERIORITY_OR_OTHER|||||||0.02|||||||Type 3 Wald Test|||Overall p-value of the day by treatment interaction from the random effects model using a type 3 Wald test.||||0.02
71076923|NCT01783821|141663254|SUPERIORITY_OR_OTHER|||||||0.01|||||||Fisher Exact|||Comparison between the two arms for the 3 categories.||||0.01
71076924|NCT01783821|141663255|SUPERIORITY_OR_OTHER|||||||0.01|||||||Chi-squared|||||||0.01
71076925|NCT01783821|141663256|SUPERIORITY_OR_OTHER|||||||0.01|||||||Fisher Exact|||||||0.01
71076926|NCT01783821|141663257|SUPERIORITY_OR_OTHER|||||||0.02|||||||Cox Proportional Hazard, Fine/Gray adj.|||||||0.02
71076927|NCT01783821|141663258|SUPERIORITY_OR_OTHER|||||||0.01|||||||Kruskal-Wallis|||||||0.01
71076928|NCT01907217|141663259|NON_INFERIORITY_OR_EQUIVALENCE|"The prespecified noninferiority margin was no more than a -4 point difference at the end of treatment between the bilateral and unilateral groups.~The predicted difference at the end of treatment was 1.08 (95% confidence interval \[CI\] = -1.67 to 3.84."|Mean Difference (Final Values)|1.08|||<|0.05|TWO_SIDED|95.0|-1.67|3.84||Primary statistical analysis was assessment of difference in HAM-D scores between arms at end-of-treatment, supplemented by 95% CIs and this interval compared with the pre-specified noninferiority threshold (-4 points). The p-value was calculated.|Regression, Linear|A regression model was fitted to end-of-treatment HAM-D measures, with baseline HAM-D scores, trial arm, randomization stratifiers as covariates.|The prespecified noninferiority margin was no more than a -4-point difference at the end of treatment between bitemporal and unilateral groups. The predicted difference at the end of treatment was 1.08 (95% confidence interval \[CI\]=-1.67 to 3.84).|Based on a large bitemporal ECT series, we estimated that 69 patients were required per group to have 80% power to demonstrate, using a one-sided equivalence t test at 5% level, that the mean reduction in the 24-item HAM-D score following high-dose unilateral ECT was no more than 4 points (i.e., equivalent to 3 points on the 17-item HAM-D, deemed to be clinically relevant \[30\]) less than that achieved using bitemporal ECT.||3.84|-1.67|<0.05
71076929|NCT01907217|141663260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.001|TWO_SIDED|95.0|0.51|0.85||As above|generalized linear models with a binomia|||"The AMI-SF at end of treatment was analyzed using generalized linear models with a binomial distribution and logit-link. Post treatment AMI-SF measures provide the number of baseline items recalled after ECT; such number of items recalled variables were therefore modeled as arising from binomial distributions, with maximum number of possible recalls set to the number of items obtained at baseline."||0.85|0.51|0.001
71076930|NCT01907217|141663261|SUPERIORITY||Odds Ratio (OR)|0.59||||0.001|TWO_SIDED|95.0|0.45|0.78|||Regression, Linear|Analyzed using a generalized linear models with a binomial distribution and logit-link.||||0.78|0.45|0.001
71076931|NCT01907217|141663262|SUPERIORITY||Odds Ratio (OR)|0.59||||0.001|TWO_SIDED|95.0|0.45|0.79|||Regression, Linear|generalized linear models with a binomial distribution and logit-link||||0.79|0.45|0.001
71076932|NCT01180049|141663270|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.731|||||TWO_SIDED|80.0|0.52|1.027||||||||1.027|0.520|
71076933|NCT01180049|141663271|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.778|||||TWO_SIDED|80.0|0.568|1.064||||||||1.064|0.568|
71076934|NCT01180049|141663272|SUPERIORITY_OR_OTHER||Difference in arms|6.7|||||TWO_SIDED|80.0|-6.9|20.3||||||Independent assessment- Difference (%) TEMSR 175/75 mg - TEMSR 75 mg (80% CI)||20.3|-6.9|
71076935|NCT01180049|141663273|SUPERIORITY_OR_OTHER||Difference between arms|13.3|||||TWO_SIDED|80.0|-0.4|26.7||||||Investigator's assessment- Difference (%)TEMSR 175/75 mg - TEMSR 75 mg (80% CI)||26.7|-0.4|
71076936|NCT01180049|141663274|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.646|||||TWO_SIDED|80.0|0.453|0.922||||||||0.922|0.453|
71076937|NCT00350779|141663279|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.72|STANDARD_DEVIATION|0.87|<|0.001||95.0|-0.95|-0.49|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy||||-0.49|-0.95|<0.001
71076938|NCT00350779|141663280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.0|STANDARD_DEVIATION|31.3|<|0.001||95.0|-27.2|-10.9|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy||||-10.9|-27.2|<0.001
71076939|NCT00350779|141663281|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-37.9|STANDARD_DEVIATION|43.7|<|0.001||95.0|-50.2|-25.5|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy||||-25.5|-50.2|<0.001
71076940|NCT00350779|141663282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.77|STANDARD_DEVIATION|1.04|<|0.001||95.0|-1.04|-0.5|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy||||-0.50|-1.04|<0.001
71076941|NCT00350779|141663283|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.4|STANDARD_DEVIATION|34.6|<|0.001||95.0|-26.4|-8.4|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy||||-8.4|-26.4|<0.001
71076942|NCT00350779|141663284|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.1|STANDARD_DEVIATION|51.0|<|0.001||95.0|-48.4|-19.9|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy||||-19.9|-48.4|<0.001
71076943|NCT03003000|141663437|SUPERIORITY||Mean Difference (Final Values)|0.156||||0.3446|TWO_SIDED|95.0|-0.168|0.48||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Mixed effect Model Repeated Measurement||Adjusted mean change from baseline ibuprofen and caffeine - Adjusted mean change from baseline placebo. A positive result favors the treatment with ibuprofen and caffeine|Superiority of ibuprofen and caffeine versus ibuprofen as well as ibuprofen and caffeine versus placebo had to be shown to reject the overall null hypothesis that there is no difference in change in POMWP between baseline and Day 2 (morning, 2 h after drug intake) between patients treated with ibuprofen/caffeine and patients treated with placebo.|Mixed effect model for repeated measures analysis (MMRM) includes fixed, categorical effects of treatment, country, worst procedure site, time and interaction terms for treatment-by-time, treatment-by-stratum-by-time, treatment-by-stratum and stratum-by-time interaction, as well as the continuous fixed covariates of baseline POMwp and baseline-by-time interaction, using unstructured covariance matrix.|0.480|-0.168|0.3446
71076944|NCT03003000|141663437|SUPERIORITY||Mean Difference (Final Values)|-0.129||||0.3358|TWO_SIDED|95.0|-0.392|0.134||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Mixed effect Model Repeat Measurement||Adjusted mean change from baseline ibuprofen and caffeine - Adjusted mean change from baseline ibuprofen. A positive result favors the treatment with ibuprofen and caffeine|Superiority of ibuprofen and caffeine versus ibuprofen as well as ibuprofen and caffeine versus placebo had to be shown to reject the overall null hypothesis that there is no difference in change in POMWP between baseline and Day 2 (morning, 2 h after drug intake) between patients treated with ibuprofen/caffeine and patients treated with ibuprofen.|Mixed effect model for repeated measures analysis (MMRM) includes fixed, categorical effects of treatment, country, worst procedure site, time and interaction terms for treatment-by-time, treatment-by-stratum-by-time, treatment-by-stratum and stratum-by-time interaction, as well as the continuous fixed covariates of baseline POMwp and baseline-by-time interaction, using unstructured covariance matrix|0.134|-0.392|0.3358
71076945|NCT03003000|141663438|SUPERIORITY||Mean Difference (Final Values)|-0.288||||0.0474|TWO_SIDED|95.0|-0.572|-0.003||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|ANCOVA|ANCOVA included treatment, country, and worst procedure site as fixed effects and baseline POMwp as a continuous covariate.|Adjusted mean ibuprofen and caffeine - Adjusted mean placebo. A negative result favors ibuprofen and caffeine|||-0.003|-0.572|0.0474
71076946|NCT03003000|141663438|SUPERIORITY||Mean Difference (Final Values)|0.051||||0.6658|TWO_SIDED|95.0|-0.18|0.282||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|ANCOVA|The ANCOVA included treatment, country, and worst procedure site as fixed effects and baseline POMwp as a continuous covariate.|Adjusted mean ibuprofen and caffeine - Adjusted mean ibuprofen. A negative result favors ibuprofen and caffeine.|||0.282|-0.180|0.6658
71076947|NCT03003000|141663439|SUPERIORITY||Mean Difference (Final Values)|-0.399||||0.0091|TWO_SIDED|95.0|-0.698|-0.1||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|ANCOVA|The ANCOVA included treatment, country, and worst procedure site as fixed effects and baseline POMwp as a continuous covariate.|Adjusted mean ibuprofen and caffeine - Adjusted mean placebo. A negative result favors ibuprofen and caffeine|||-0.100|-0.698|0.0091
71076948|NCT03003000|141663439|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.6387|TWO_SIDED|95.0|-0.185|0.302||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|ANCOVA|The ANCOVA included treatment, country, and worst procedure site as fixed effects and baseline POMwp as a continuous covariate.|Adjusted mean ibuprofen and caffeine - Adjusted mean ibuprofen. A negative result favors ibuprofen and caffeine|||0.302|-0.185|0.6387
71076949|NCT03003000|141663440|SUPERIORITY||Mean Difference (Final Values)|0.559||||0.4398|TWO_SIDED|95.0|-0.861|1.979||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Mixed effect model for repeated measures||Adjusted mean change ibuprofen and caffeine - Adjusted mean change placebo. A negative result favors ibuprofen and caffeine.|Mixed effect model for repeated measures (MMRM) includes fixed, categorical effects of treatment, country, worst procedure site, time and interaction terms for treatment-by-time as well as the continuous fixed covariates of baseline pressure algometry and baseline-by-time interaction, using unstructured covariance matrix.||1.979|-0.861|0.4398
71117047|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.06||||0.435|TWO_SIDED|95.0|-0.08|0.2|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.20|-0.08|0.435
71117048|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.16||||0.023|TWO_SIDED|95.0|0.02|0.31|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.31|0.02|0.023
71117049|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.82|||<|0.001|TWO_SIDED|95.0|0.52|1.12|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.12|0.52|<0.001
71117050|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.67|||<|0.001|TWO_SIDED|95.0|0.37|0.97|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.97|0.37|<0.001
71117051|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.74|||<|0.001|TWO_SIDED|95.0|0.45|1.04|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.04|0.45|<0.001
71117052|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.45||||0.003|TWO_SIDED|95.0|0.16|0.75|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.75|0.16|0.003
71117053|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.37|||<|0.001|TWO_SIDED|95.0|0.16|0.58|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.58|0.16|<0.001
71117054|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.22||||0.039|TWO_SIDED|95.0|0.01|0.42|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.42|0.01|0.039
70941143|NCT02123797|141382159|SUPERIORITY||Odds Ratio (OR)|2.58||||0.0366|TWO_SIDED|95.0|1.665|3.996||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without invasive staging (numerator=108/70) to Serial Care patients not in conference with and without invasive staging (denominator=122/150) after adjustment for matched study design.|||3.996|1.665|0.0366
71117055|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.29||||0.006|TWO_SIDED|95.0|0.08|0.5|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.50|0.08|0.006
71117056|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.33|||<|0.001|TWO_SIDED|95.0|1.01|1.65|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.65|1.01|<0.001
71117057|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.17|||<|0.001|TWO_SIDED|95.0|0.85|1.49|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.49|0.85|<0.001
71117058|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.35|||<|0.001|TWO_SIDED|95.0|1.03|1.67|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.67|1.03|<0.001
71117059|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.04|||<|0.001|TWO_SIDED|95.0|0.72|1.36|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.36|0.72|<0.001
71117060|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.29||||0.011|TWO_SIDED|95.0|0.07|0.52|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.52|0.07|0.011
71117061|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.13||||0.267|TWO_SIDED|95.0|-0.1|0.35|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.35|-0.10|0.267
71117062|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.31||||0.007|TWO_SIDED|95.0|0.09|0.53|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.53|0.09|0.007
71117063|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.57|||<|0.001|TWO_SIDED|95.0|1.24|1.89|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.89|1.24|<0.001
71117064|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.38|||<|0.001|TWO_SIDED|95.0|1.06|1.7|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.70|1.06|<0.001
70941144|NCT02123797|141382159|SUPERIORITY||Odds Ratio (OR)|2.621||||0.0779|TWO_SIDED|95.0|1.473|4.665||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Serial Care patients in conference with and without invasive staging (numerator=46/30) to Serial Care patients not in conference with and without invasive staging (denominator=122/150) after adjustment for matched study design.|||4.665|1.473|0.0779
70941145|NCT02123797|141382160|SUPERIORITY||Odds Ratio (OR)|2.358||||0.0703|TWO_SIDED|95.0|1.536|3.621||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without mediastinal staging (numerator=91/87) to Serial Care patients not in conference with and without mediastinal staging (denominator=86/186) after adjustment for matched study.|||3.621|1.536|0.0703
71076950|NCT03003000|141663440|SUPERIORITY||Mean Difference (Final Values)|0.156||||0.7911|TWO_SIDED|95.0|-1.002|1.314||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Mixed effect Model Repeat Measurement||Adjusted mean change ibuprofen and caffeine - Adjusted mean change ibuprofen. A negative result favors ibuprofen and caffeine.|MMRM includes fixed, categorical effects of treatment, country, worst procedure site, time and interaction terms for treatment-by-time as well as the continuous fixed covariates of baseline pressure algometry and baseline-by-time interaction, using unstructured covariance matrix.||1.314|-1.002|0.7911
70853778|NCT04345367|141195678|OTHER||Estimate of difference|0.7|||||TWO_SIDED|95.0|-5.9|7.2|||||Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||7.2|-5.9|
71076951|NCT03003000|141663441|SUPERIORITY||Odds Ratio (OR)|1.777||||0.0045|TWO_SIDED|95.0|1.195|2.642||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Regression, Logistic|An ordinal logistic regression model adjusting for country and worst procedure site.|An odds ratio \>1 indicates better efficacy for ibuprofen and caffeine than for the comparator|||2.642|1.195|0.0045
71076952|NCT03003000|141663441|SUPERIORITY||Odds Ratio (OR)|1.008||||0.9603|TWO_SIDED|95.0|0.732|1.389||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Regression, Logistic|An ordinal logistic regression model adjusting for country and worst procedure site.|An odds ratio \>1 indicates better efficacy for ibuprofen and caffeine than for the comparator|||1.389|0.732|0.9603
71076953|NCT03003000|141663442|SUPERIORITY||Odds Ratio (OR)|1.028||||0.9022|TWO_SIDED|95.0|0.663|1.592||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|likelihood-ratio test|The likelihood-ratio test was used to test treatment differences for patients with a decrease of ≥30%.|An odds ratio \>1 indicates better efficacy for ibuprofen and caffeine than for the comparator.||Results are based on the Logistic regression. Logistic regression model was adjusted for the categorical covariates country and worst procedure site.|1.592|0.663|0.9022
71076954|NCT03003000|141663442|SUPERIORITY||Odds Ratio (OR)|0.834||||0.3129|TWO_SIDED|95.0|0.586|1.187||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|likelihood-ratio test|The likelihood-ratio test was used to test treatment differences for patients with a decrease of ≥30%.|An odds ratio \>1 indicates better efficacy for ibuprofen and caffeine than for the comparator.||Results are based on the Logistic regression. Logistic regression model was adjusted for the categorical covariates country and worst procedure site.|1.187|0.586|0.3129
71076955|NCT03003000|141663442|SUPERIORITY||Odds Ratio (OR)|1.354||||0.3301|TWO_SIDED|95.0|0.736|2.494||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|likelihood-ratio test|The likelihood-ratio test was used to test treatment differences for patients with a decrease of ≥50%.|An odds ratio \>1 indicates better efficacy for ibuprofen and caffeine than for the comparator||Results are based on the Logistic regression. Logistic regression model was adjusted for the categorical covariates country and worst procedure site.|2.494|0.736|0.3301
71076956|NCT03003000|141663442|SUPERIORITY||Odds Ratio (OR)|0.68||||0.0864|TWO_SIDED|95.0|0.437|1.057||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|likelihood-ratio test|The likelihood-ratio test was used to test treatment differences for patients with a decrease of ≥50%.|An odds ratio \>1 indicates better efficacy for ibuprofen and caffeine than for the comparator||Results are based on the Logistic regression. Logistic regression model was adjusted for the categorical covariates country and worst procedure site.|1.057|0.437|0.0864
70853779|NCT04345367|141195679|OTHER||Estimate of difference|7.3|||||TWO_SIDED|95.0|2.8|11.7|||||Week 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.7|2.8|
70941146|NCT02123797|141382160|SUPERIORITY||Odds Ratio (OR)|2.535||||0.0631|TWO_SIDED|95.0|1.446|4.444||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Serial Care patients in conference with and without mediastinal staging (numerator=40/36) to Serial Care patients not in conference with and without mediastinal staging (denominator=86/186) after adjustment for matched study.|||4.444|1.446|0.0631
70853780|NCT04345367|141195679|OTHER||Estimate of difference|20.6|||||TWO_SIDED|95.0|14.3|26.9|||||Week 4. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||26.9|14.3|
70941147|NCT02123797|141382161|SUPERIORITY||Odds Ratio (OR)|3.191||||0.001|TWO_SIDED|95.0|1.671|6.093||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without bi-modal staging (numerator=161/17) to Serial Care patients not in conference with and without bi-modal staging (denominator=205/67) after adjustment for matched study.|||6.093|1.671|0.0010
71076957|NCT03003000|141663443|SUPERIORITY|||||||0.9384||||||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Log Rank|p-value based on a stratified log-rank test||||||0.9384
70853781|NCT04345367|141195679|OTHER||Estimate of difference|19.5|||||TWO_SIDED|95.0|12.5|26.4|||||Week 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||26.4|12.5|
70853782|NCT04345367|141195679|OTHER||Estimate of difference|15.8|||||TWO_SIDED|95.0|8.7|23.0|||||Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||23.0|8.7|
70941148|NCT02123797|141382161|SUPERIORITY||Odds Ratio (OR)|1.103||||0.1972|TWO_SIDED|95.0|0.526|2.314||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Serial Care patients in conference with and without bi-modal staging (numerator=62/14) to Serial Care patients not in conference with and without bi-modal staging (denominator=205/67) after adjustment for matched study.|||2.314|0.526|0.1972
70941149|NCT02123797|141382162|SUPERIORITY||Odds Ratio (OR)|2.739||||0.0055|TWO_SIDED|95.0|1.785|4.203|||Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without tri-modal staging (numerator=99/79) to Serial Care patients not in conference with and without tri-modal staging (denominator=93/179) after adjustment for matched study.|||4.203|1.785|0.0055
70941150|NCT02123797|141382162|SUPERIORITY||Odds Ratio (OR)|2.242||||0.2572|TWO_SIDED|95.0|1.287|3.905||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Serial Care patients in conference with and without tri-modal staging (numerator=39/37) to Serial Care patients not in conference with and without tri-modal staging (denominator=93/179) after adjustment for matched study.|||3.905|1.287|0.2572
70941151|NCT02123797|141382163|SUPERIORITY||Odds Ratio (OR)|2.01||||0.0045|TWO_SIDED|95.0|1.24|3.25||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without stage appropriate treatment (numerator=140/33) to SC patients with and without stage appropriate treatment (denominator=232/106) after adjustment for matched study.|||3.25|1.24|0.0045
71076958|NCT03003000|141663443|SUPERIORITY|||||||0.3534||||||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Log Rank|p-value based on a stratified log-rank test||||||0.3534
71076959|NCT03743402|141663456|EQUIVALENCE|The null hypothesis was a point null of exactly 0 expected difference in MME/day between arms.|Mean Difference (Final Values)|-2.54||||0.58|TWO_SIDED|95.0|-10.55|5.88|||Regression, Linear||mean difference=(pain self-management)-(usual care)|A priori power calculations indicated 90% power to detect an average 24 MME/day difference between arms.||5.88|-10.55|0.58
70853783|NCT04345367|141195679|OTHER||Estimate of difference|13.0|||||TWO_SIDED|95.0|5.9|20.2|||||Week 16. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||20.2|5.9|
70853784|NCT04345367|141195679|OTHER||Estimate of difference|9.2|||||TWO_SIDED|95.0|2.0|16.4|||||Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||16.4|2.0|
70853785|NCT04345367|141195679|OTHER||Estimate of difference|4.5|||||TWO_SIDED|95.0|-2.8|11.8|||||Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.8|-2.8|
70941152|NCT02123797|141382164|SUPERIORITY||Odds Ratio (OR)|2.249||||0.0474|TWO_SIDED|95.0|1.368|3.699||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without stage appropriate treatment (numerator=140/33) to SC patients not in conference with and without stage appropriate treatment (denominator=174/91) after adjustment for matched study.|We examined treatment selection practices with or without MD care in a single healthcare system.||3.699|1.368|0.0474
70941153|NCT02123797|141382164|SUPERIORITY||Odds Ratio (OR)|1.751||||0.6353|TWO_SIDED|95.0|0.91|3.37||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing SC patients in conference with and without stage appropriate treatment (numerator=58/15) to SC patients not in conference with and without stage appropriate treatment (denominator=174/91) after adjustment for matched study.|||3.370|0.910|0.6353
70941154|NCT02123797|141382166|SUPERIORITY||Odds Ratio (OR)|2.955||||0.0014|TWO_SIDED|95.0|1.52|5.747||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without concordance to recommendations (numerator=140/37) to SC conference patients with and without concordance to recommendations (denominator=45/30) after adjustment for matched study design.|||5.747|1.520|0.0014
71076960|NCT03743402|141663457|EQUIVALENCE|The null hypothesis was a point null of exactly 0 expected difference in PEG score between arms.|Mean Difference (Final Values)|0.01||||0.98|TWO_SIDED|95.0|-0.51|0.52|||Regression, Linear||mean difference = (pain self-management)-(usual care)|A priori power calculations indicated 90% power to detect a 1.2-point average difference in PEG score between arms.||0.52|-0.51|0.98
71076961|NCT03743402|141663458|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in average MME/day between arms.|Mean Difference (Final Values)|1.3||||0.72|TWO_SIDED|95.0|-5.69|8.29|||Regression, Linear||mean difference=(pain self-management)-(usual care)|||8.29|-5.69|0.72
70941155|NCT02123797|141382167|SUPERIORITY||Odds Ratio (OR)|3.093||||0.0019|TWO_SIDED|95.0|1.519|6.299||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without concordance to recommendations (numerator=145/32) to SC conference patients with and without concordance to recommendations (denominator=49/26) after adjustment for matched study design.|||6.299|1.519|0.0019
71076962|NCT03743402|141663459|EQUIVALENCE|The null hypothesis is a point null of exactly 0 difference in expected PEG score between arms.|Mean Difference (Final Values)|-0.53||||0.07|TWO_SIDED|95.0|-1.11|0.05|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.05|-1.11|0.07
71076963|NCT03743402|141663460|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PSEQ score between arms.|Mean Difference (Final Values)|2.11||||0.8|TWO_SIDED|95.0|-13.83|18.04|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||18.04|-13.83|0.80
71076964|NCT03743402|141663461|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PSEQ score between arms.|Mean Difference (Final Values)|4.33||||0.02|TWO_SIDED|95.0|0.56|8.09|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||8.09|0.56|0.02
71076965|NCT03743402|141663462|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PHQ-8 score between arms.|Mean Difference (Final Values)|-0.35||||0.75|TWO_SIDED|95.0|-2.53|1.82|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||1.82|-2.53|0.75
71076966|NCT03743402|141663463|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PHQ-8 score between arms.|Mean Difference (Final Values)|-0.5||||0.48|TWO_SIDED|95.0|-1.87|0.87|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.87|-1.87|0.48
71076967|NCT03743402|141663464|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in GAD-7 score between arms.|Mean Difference (Final Values)|-0.25||||0.64|TWO_SIDED|95.0|-1.31|0.81|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.81|-1.31|0.64
71076968|NCT03743402|141663465|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in GAD-7 score between arms.|Mean Difference (Final Values)|0.28||||0.65|TWO_SIDED|95.0|-0.94|1.51|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||1.51|-0.94|0.65
71076969|NCT03743402|141663466|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PGIC score between arms.|Mean Difference (Final Values)|0.61||||0.02|TWO_SIDED|95.0|0.12|1.1|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||1.10|0.12|0.02
71076970|NCT03743402|141663467|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PGIC score between arms.|Mean Difference (Final Values)|1.33|||<|0.01|TWO_SIDED|95.0|0.77|1.88|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||1.88|0.77|<0.01
71076971|NCT03743402|141663468|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in POMI score between arms.|Mean Difference (Final Values)|0.09||||0.42|TWO_SIDED|95.0|-0.13|0.31|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.31|-0.13|0.42
71076972|NCT03743402|141663469|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in POMI score between arms.|Mean Difference (Final Values)|0.13||||0.26|TWO_SIDED|95.0|-0.1|0.36|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.36|-0.10|0.26
71076973|NCT03743402|141663470|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PODS score between arms.|Mean Difference (Final Values)|1.6||||0.54|TWO_SIDED|95.0|-3.47|6.66|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||6.66|-3.47|0.54
71076974|NCT03743402|141663471|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PODS score between arms.|Mean Difference (Final Values)|0.48||||0.59|TWO_SIDED|95.0|-1.26|2.21|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||2.21|-1.26|0.59
71076975|NCT03743402|141663472|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in opioid craving score between arms.|Mean Difference (Final Values)|-0.04||||0.9|TWO_SIDED|95.0|-0.66|0.57|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.57|-0.66|0.90
71076976|NCT03743402|141663473|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PSEQ score between arms.|Mean Difference (Final Values)|-0.35||||0.3|TWO_SIDED|95.0|-1.03|0.32|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.32|-1.03|0.30
71076977|NCT03743402|141663474|EQUIVALENCE|The null hypothesis is a point null of the relative risk of 30% reduction from baseline equal exactly to 1.|Risk Ratio (RR)|2.1||||0.2|TWO_SIDED|95.0|0.68|6.53|||Regression, Poison||relative risk = (pain self-management)/(usual care)|||6.53|0.68|0.20
71076978|NCT03743402|141663475|EQUIVALENCE|The null hypothesis is a point null of the relative risk of 30% reduction from baseline equal exactly to 1.|Risk Ratio (RR)|1.34||||0.53|TWO_SIDED|95.0|0.54|3.32|||Regression, Poison||relative risk = (pain self-management)/(usual care)|||3.32|0.54|0.53
70853786|NCT04345367|141195680|OTHER||Estimate of difference|7.1|||||TWO_SIDED|95.0|3.1|11.1|||||Day 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.1|3.1|
70853787|NCT04345367|141195680|OTHER||Estimate of difference|6.5|||||TWO_SIDED|95.0|1.7|11.3|||||Day 3. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.3|1.7|
70853788|NCT04345367|141195680|OTHER||Estimate of difference|11.4|||||TWO_SIDED|95.0|6.0|16.8|||||Day 4. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||16.8|6.0|
70853789|NCT04345367|141195680|OTHER||Estimate of difference|14.5|||||TWO_SIDED|95.0|8.8|20.3|||||Day 5. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||20.3|8.8|
70853790|NCT04345367|141195680|OTHER||Estimate of difference|12.9|||||TWO_SIDED|95.0|6.9|19.0|||||Day 6. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||19.0|6.9|
70853791|NCT04345367|141195680|OTHER||Estimate of difference|19.9|||||TWO_SIDED|95.0|13.8|26.0|||||Day 7. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||26.0|13.8|
70853792|NCT04345367|141195680|OTHER||Estimate of difference|22.1|||||TWO_SIDED|95.0|15.9|28.3|||||Day 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||28.3|15.9|
70853793|NCT04345367|141195680|OTHER||Estimate of difference|21.7|||||TWO_SIDED|95.0|15.2|28.1|||||Day 9. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||28.1|15.2|
70853794|NCT04345367|141195680|OTHER||Estimate of other|21.3|||||TWO_SIDED|95.0|14.7|27.9|||||Day 10. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||27.9|14.7|
70853795|NCT04345367|141195680|OTHER||Estimate of difference|20.0|||||TWO_SIDED|95.0|13.3|26.6|||||Day 11. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||26.6|13.3|
70853796|NCT04345367|141195680|OTHER||Estimate of difference|21.3|||||TWO_SIDED|95.0|14.6|27.9|||||Day 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||27.9|14.6|
71076979|NCT02191046|141663476|NON_INFERIORITY_OR_EQUIVALENCE|power of study = 90%|Mean Difference (Final Values)|4.38|STANDARD_DEVIATION|2.89|<|0.05|TWO_SIDED|95.0|3.41|5.37|||t-test, 2 sided|||compare the mean 5S-score between before and after treatment in syringe group||5.37|3.41|<0.05
71076980|NCT02191046|141663476|NON_INFERIORITY_OR_EQUIVALENCE|power of study = 90%|Mean Difference (Net)|0.93|STANDARD_DEVIATION|0.42|<|0.05|TWO_SIDED|95.0|0.094|1.76|||t-test, 2 sided|||compare the mean 5S-score between 2 groups at 2 weeks after treatment||1.76|0.094|<0.05
71076981|NCT02191046|141663476|NON_INFERIORITY_OR_EQUIVALENCE|power of study = 90%|Mean Difference (Net)|-0.47|STANDARD_DEVIATION|0.17|<|0.05|TWO_SIDED|95.0|-0.82|-0.12|||t-test, 2 sided|||satisfaction score between two groups at 2 weeks after treatment||-0.12|-0.82|<0.05
70853797|NCT04345367|141195680|OTHER||Estimate of difference|22.5|||||TWO_SIDED|95.0|15.8|29.2|||||Day 13. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||29.2|15.8|
71076982|NCT02191046|141663476|NON_INFERIORITY_OR_EQUIVALENCE|power fo study = 90%|Mean Difference (Final Values)|5.66|STANDARD_DEVIATION|3.16|<|0.05|TWO_SIDED|95.0|4.62|6.69|||t-test, 2 sided|||compare the mean 5s-score between before and after treatment in squeezable bottle group||6.69|4.62|<0.05
71076983|NCT04006509|141663528|SUPERIORITY|||||||0.985|||||||Wilcoxon (Mann-Whitney)|||||||0.985
71076984|NCT04006509|141663529|SUPERIORITY|||||||0.539|||||||Marginal Two-Part Model|||||||0.539
71076985|NCT04006509|141663530|SUPERIORITY|||||||0.959|||||||Wilcoxon (Mann-Whitney)|||||||0.959
71076986|NCT04006509|141663531|SUPERIORITY|||||||0.743|||||||Marginal Two-Part Model|||||||0.743
71076987|NCT04006509|141663532|SUPERIORITY|||||||0.886|||||||Marginalized Two-Part Model|||||||0.886
71076988|NCT04006509|141663533|SUPERIORITY|||||||0.107|||||||Marginalized Two-Part Model|||||||0.107
71076989|NCT04006509|141663534|SUPERIORITY|||||||0.687|||||||Marginalized Two-Part Model|||||||0.687
71076990|NCT04006509|141663535|SUPERIORITY|||||||0.871|||||||Marginalized Two-Part Model|||||||0.871
71076991|NCT04006509|141663536|SUPERIORITY|||||||0.376|||||||Marginalized Two-Part Model|||||||0.376
71076992|NCT04006509|141663537|SUPERIORITY|||||||0.77|||||||Marginalized Two-Part Model|||||||0.770
71076993|NCT04006509|141663538|SUPERIORITY|||||||0.237|||||||Marginalized Two-Part Model|||||||0.237
71076994|NCT00048997|141663543|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.2853|TWO_SIDED|95.0|0.84|1.38||One-sided significance level of 0.025.|Log Rank||Prophylactic cranial irradiation (PCI) is the reference arm for the hazard ratio.|This study was designed to detect a 20% relative improvement in hazard rate: null hypothesis (observation): MST (median survival time) = 23.5 mo.; alternative hypothesis (PCI): MST= 29.4 mo. A one-sided log-rank test at a significance level of 0.025 would have 80% power to detect this difference with a sample size of 1007 patients (527 deaths were required for the final analysis).||1.38|0.84|0.2853
71076995|NCT00048997|141663544|SUPERIORITY|||||||0.01|||||||Z-test, 2-sided|2-sided significance level = 0.05||||||0.01
71076996|NCT00048997|141663545|SUPERIORITY|||||||0.008|||||||Z-test, 2-sided|Significance level = 0.05||||||0.008
71076997|NCT00048997|141663546|SUPERIORITY|||||||0.2|||||||Z-test, 2-sided|Significance level = 0.05||||||0.20
71076998|NCT00048997|141663547|SUPERIORITY|||||||0.14|||||||Z-test, 2-sided|Significance level = 0.05||||||0.14
71076999|NCT00048997|141663548|SUPERIORITY|||||||0.52|||||||Z-test, 2-sided|Significance level = 0.05||||||0.52
71077000|NCT00048997|141663549|SUPERIORITY|||||||0.51|||||||Z-test, 2-sided|Significance level = 0.05||||||0.51
71077001|NCT00048997|141663550|SUPERIORITY|||||||0.11|||||||Other [Z-test, 2-sided]|Significance level = 0.05||||||0.11
71077002|NCT00048997|141663551|SUPERIORITY||Odds Ratio (OR)|2.52||||0.005|TWO_SIDED|95.0|1.32|4.8|||Regression, Logistic|2-sided significance level = 0.05|Reference level = PCI arm|The development of CNS metastases was assessed using logistic regression modeling comparing presence vs. absence of brain metastases at 1 year.||4.80|1.32|0.005
71077003|NCT02759835|141663569|OTHER|||||||0.56|||||||Kaplan-Meier|||||||0.56
71077004|NCT02759835|141663571|OTHER|||||||0.4|||||||Kaplan-Meier|||||||0.40
71077005|NCT02007278|141663583|NON_INFERIORITY_OR_EQUIVALENCE|Power=95%; significance level=5%, characteristic operation curves were used with a non-central F distribution for the calculation of the sample size||||||0.451|||||||Wilcoxon (Mann-Whitney)|||||||0.4510
71077006|NCT04475718|141663591|OTHER|Preliminary Efficacy|||||<|0.001|||||||t-test, 2 sided|||||||<.001
71077007|NCT00435188|141663597|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Omnibus p value for group difference between groups at the end of the study and group by time interaction|Mixed Models Analysis|||||||<0.001
71077008|NCT00435188|141663600|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||Mixed Models Analysis|||Omnibus P value reporting overall differences between groups for group and group by time interaction with two degrees of freedom||||0.47
71077009|NCT00435188|141663603|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Mixed Models Analysis|||Omnibus P value for overall difference between groups at the end of the study and group by time interaction on two degrees of freedom||||0.04
71077010|NCT00435188|141663604|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Omnibus P value provides the overall differences between groups at the end of the study||||<0.001
71077011|NCT00435188|141663607|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Mixed Models Analysis|||Omnibus P value provides the overall difference between groups at the end of the study||||0.29
71077012|NCT00435188|141663610|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Mixed Models Analysis|||P value provides overall differences between groups at the end of the study||||0.35
71077013|NCT00435188|141663613|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Mixed Models Analysis|||P value provides the overall differences between groups at the end of the study||||0.08
71077014|NCT00055497|141663626|SUPERIORITY_OR_OTHER|||||||0.142|||||||Log Rank|||||||0.142
71077015|NCT00055497|141663627|SUPERIORITY_OR_OTHER|||||||0.029|||||||Fisher Exact|||||||0.029
71077016|NCT00055497|141663628|SUPERIORITY_OR_OTHER|||||||0.33|||||||Fisher Exact|||Week 24||||0.330
71077017|NCT00055497|141663628|SUPERIORITY_OR_OTHER|||||||0.001|||||||Fisher Exact|||Week 24||||0.001
71077018|NCT00055497|141663628|SUPERIORITY_OR_OTHER|||||||0.508|||||||Fisher Exact|||Week 56||||0.508
71077019|NCT00055497|141663628|SUPERIORITY_OR_OTHER|||||||0.044|||||||Fisher Exact|||Week 56||||0.044
71077020|NCT00055497|141663629|SUPERIORITY_OR_OTHER|||||||0.191|||||||Fisher Exact|||Week 24||||0.191
71077021|NCT00055497|141663629|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||Week 24||||0.003
71077022|NCT00055497|141663629|SUPERIORITY_OR_OTHER|||||||0.508|||||||Fisher Exact|||Week 56||||0.508
70941156|NCT02123797|141382168|SUPERIORITY||Odds Ratio (OR)|40.892||||0.0499|TWO_SIDED|95.0|1.002|999.999||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without concordance to recommendations (numerator=174/3) to SC conference patients with and without concordance to recommendations (denominator=71/4) after adjustment for matched study design.|||999.999|1.002|0.0499
70853798|NCT04345367|141195680|OTHER||Estimate of difference|22.4|||||TWO_SIDED|95.0|15.6|29.2|||||Day 14. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||29.2|15.6|
70941157|NCT02123797|141382169|SUPERIORITY||Odds Ratio (OR)|2.663||||0.0263|TWO_SIDED|95.0|1.123|6.319||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without concordance to recommendations (numerator=158/19) to SC conference patients with and without concordance to recommendations (denominator=60/15) after adjustment for matched study design.|||6.319|1.123|0.0263
71077023|NCT00055497|141663629|SUPERIORITY_OR_OTHER|||||||0.004|||||||Fisher Exact|||Week 56||||0.004
71077024|NCT00055497|141663630|SUPERIORITY_OR_OTHER|||||||0.001|||||||Fisher Exact|||||||0.001
71077025|NCT00048165|141663635|SUPERIORITY_OR_OTHER||percent mean difference|-12.0||||0.007|TWO_SIDED|95.0|-20.9|-3.3|||Cochran-Mantel-Haenszel|||||-3.3|-20.9|0.007
71077026|NCT00048165|141663636|SUPERIORITY_OR_OTHER||percent mean difference|-8.6||||0.063|TWO_SIDED|95.0|-17.7|0.5|||Cochran-Mantel-Haenszel|||||0.5|-17.7|0.063
71077027|NCT00048165|141663639|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Cochran-Mantel-Haenszel|||Comparison of Daclizumab and Placebo for 6 months were presented||||0.0005
71077028|NCT00048165|141663639|SUPERIORITY_OR_OTHER|||||||0.0008|||||||Cochran-Mantel-Haenszel|||Comparison of Daclizumab and Placebo for 12 months were presented||||0.0008
71077029|NCT02503254|141663675|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Reduction|82.82|||<|0.001|TWO_SIDED|95.0|78.79|86.09||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at a two-sided alpha level of 5%.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates.|"Geometric LS Mean Reduction = 100 - (CHTP 1.0 : CC ratio)~Expressed as %"|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for CHTP 1.0 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for CHTP 1.0 and CC, respectively."||86.09|78.79|<.001
71077030|NCT02503254|141663676|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Reduction|63.53|||<|0.001|TWO_SIDED|95.0|59.55|67.12||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at a two-sided alpha level of 5%.|ANCOVA|ANCOVA model on 3-HPMA levels with product, sex, cigarette consumption, and baseline value as covariates.|"Geometric LS Mean Reduction = 100 - (CHTP 1.0 : CC ratio)~Expressed as %"|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for CHTP 1.0 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for CHTP 1.0 and CC, respectively"||67.12|59.55|<0.001
71077031|NCT02503254|141663677|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Reduction|88.14|||<|0.001|TWO_SIDED|95.0|86.46|89.62||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at a two-sided alpha level of 5%.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates|"Geometric LS Mean Reduction = 100 - (CHTP 1.0 : CC ratio)~Expressed as %"|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for CHTP 1.0 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for CHTP 1.0 and CC, respectively."||89.62|86.46|<.001
71077032|NCT02503254|141663678|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|58.83|||<|0.001|TWO_SIDED|95.0|49.3|66.56||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on COHb levels with product, sex, cigarette consumption, and baseline value as covariates.|"Geometric LS Mean Reduction = 100 - (CHTP 1.0 : CC ratio)~Expressed as %"|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for CHTP 1.0 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for CHTP 1.0 and CC respectively."||66.56|49.30|<.001
71077033|NCT00073008|141663701|SUPERIORITY_OR_OTHER||Kaplan-Meier estimate|34.5||||||95.0|13.7|55.4|||||Percentage of surviving participants who were progression free 4 months after the date of randomization|||55.4|13.7|
71077034|NCT00073008|141663701|SUPERIORITY_OR_OTHER||Kaplan-Meier estimate|19.7||||||95.0|2.9|36.4|||||Percentage of surviving participants who were progression free 4 months after the date of randomization|||36.4|2.9|
71077035|NCT00073008|141663702|SUPERIORITY_OR_OTHER||Kaplan-Meier estimate|27.1||||||95.0|11.9|42.3|||||Percentage of surviving participants who were progression free 4 months after the date of randomization|||42.3|11.9|
71077036|NCT00073008|141663702|SUPERIORITY_OR_OTHER||Kaplan-Meier estimate|18.3||||||95.0|3.9|32.6|||||Percentage of surviving participants who were progression free 4 months after the date of randomization|||32.6|3.9|
70941158|NCT02123797|141382170|SUPERIORITY||Odds Ratio (OR)|2.566||||0.1503|TWO_SIDED|95.0|0.711|9.269||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without concordance to recommendations (numerator=87/14) to SC conference patients with and without concordance to recommendations (denominator=38/8) after adjustment for matched study design.|||9.269|0.711|0.1503
70941159|NCT02123797|141382183|SUPERIORITY|||||||0.0042|||||||Wilcoxon (Mann-Whitney)|||Time from Initial Detection of Lesion to Diagnostic Biopsy||||0.0042
70941160|NCT02123797|141382183|SUPERIORITY|||||||0.0805|||||||Wilcoxon (Mann-Whitney)|||Time from Initial Detection of Lesion to Non-invasive Staging Test||||0.0805
71077037|NCT02620384|141663747|SUPERIORITY||Mean Difference (Final Values)|2439.511|STANDARD_ERROR_OF_MEAN|646.2707|<|0.0001|TWO_SIDED|95.0|1160.8485|3718.1734|||t-test, 2 sided|||||3718.1734|1160.8485|<0.0001
71077038|NCT02620384|141663748|SUPERIORITY||Mean Difference (Final Values)|-2249.3294|STANDARD_ERROR_OF_MEAN|608.2782|<|0.0001|TWO_SIDED|95.0|-3454.4999|-1044.1589|||t-test, 2 sided|||||-1044.1589|-3454.4999|<0.0001
71077039|NCT02620384|141663749|SUPERIORITY||Mean Difference (Final Values)|-2.717121|STANDARD_ERROR_OF_MEAN|0.586647|<|0.0001|TWO_SIDED|95.0|-3.8637732|-1.54651|||t-test, 2 sided|||||-1.546510|-3.8637732|<0.0001
71077040|NCT02620384|141663750|SUPERIORITY||Mean Difference (Final Values)|-0.6955|STANDARD_ERROR_OF_MEAN|0.2806||0.014|TWO_SIDED|95.0|-1.2506|-0.1403||Represents BORG\_48\_hours|t-test, 2 sided||Method of estimation is for 48 hour measure.|||-.1403|-1.2506|.014
71077041|NCT02620384|141663751|SUPERIORITY||Mean Difference (Final Values)|3.6903|STANDARD_ERROR_OF_MEAN|72.4074||0.959|TWO_SIDED|95.0|-1395694.0|147.1545|||t-test, 2 sided|||||147.1545|-1395694|.959
71077042|NCT02620384|141663752|SUPERIORITY|||||||0.144|||||||Chi-squared|||||||.144
71077043|NCT02620384|141663753|SUPERIORITY|||||||0.171|||||||Chi-squared|||||||.171
71077044|NCT02620384|141663754|SUPERIORITY||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.734||0.885|TWO_SIDED|95.0|-1.346|1.558|||t-test, 2 sided|||||1.558|-1.346|.885
71077045|NCT02620384|141663755|SUPERIORITY|||||||0.804|||||||Chi-squared|||||||.804
71077046|NCT02620384|141663756|SUPERIORITY|||||||0.403|||||||Chi-squared|||||||.403
71077047|NCT02620384|141663757|SUPERIORITY|||||||0.08|||||||Chi-squared|||||||.080
71077048|NCT02620384|141663758|SUPERIORITY|||||||0.559|||||||Chi-squared|||||||.559
71077049|NCT02494401|141663787|SUPERIORITY|||||||0.87||||||p value of baseline comparison.|Wilcoxon (Mann-Whitney)|||||||0.87
70941161|NCT02123797|141382183|SUPERIORITY|||||||0.0073|||||||Wilcoxon (Mann-Whitney)|||Time from Initial Detection of Lesion to Invasive Staging Test||||0.0073
70941162|NCT02123797|141382183|SUPERIORITY|||||||0.0579|||||||Wilcoxon (Mann-Whitney)|||Time from Initial Detection of Lesion to Definitive Treatment||||0.0579
71077050|NCT02494401|141663787|SUPERIORITY|||||||0.32||||||p value for 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.32
71077051|NCT02494401|141663787|SUPERIORITY|||||||0.3||||||p value for 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.3
71077052|NCT02494401|141663788|SUPERIORITY|||||||0.08||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.08
71077053|NCT02494401|141663788|SUPERIORITY|||||||0.05||||||p value 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.05
71077054|NCT02494401|141663788|SUPERIORITY|||||||0.008||||||p value 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.008
71077055|NCT02494401|141663789|SUPERIORITY|||||||0.68||||||p value baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.68
71077056|NCT02494401|141663789|SUPERIORITY|||||||0.83||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.83
71077057|NCT02494401|141663789|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||||||0.23
71077058|NCT02494401|141663790|SUPERIORITY|||||||0.96||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.96
71077059|NCT02494401|141663790|SUPERIORITY|||||||0.69||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.69
71077060|NCT02494401|141663790|SUPERIORITY|||||||0.6||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.6
71077061|NCT02494401|141663791|SUPERIORITY|||||||0.89||||||p value baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.89
71077062|NCT02494401|141663791|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
71077063|NCT02494401|141663791|SUPERIORITY|||||||0.56||||||p value for 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.56
71077064|NCT02494401|141663792|SUPERIORITY|||||||0.69||||||p value for baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.69
71077065|NCT02494401|141663792|SUPERIORITY|||||||0.29||||||p value for 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.29
71077066|NCT02494401|141663792|SUPERIORITY|||||||0.07||||||p value for 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.07
71077067|NCT02494401|141663793|SUPERIORITY|||||||0.28||||||p value for baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.28
71077068|NCT02494401|141663793|SUPERIORITY|||||||0.16||||||p value for 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.16
71077069|NCT02494401|141663793|SUPERIORITY|||||||0.23||||||p value for 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.23
71077070|NCT02494401|141663794|SUPERIORITY|||||||0.93||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.93
70941163|NCT02123797|141382184|SUPERIORITY|||||||0.0146|||||||Kruskal-Wallis|||Time from Initial Detection of Lesion to Diagnostic Biopsy||||0.0146
70941164|NCT02123797|141382184|SUPERIORITY|||||||0.16|||||||Kruskal-Wallis|||Time from Initial Detection of Lesion to Non-invasive Staging Test||||0.16
71117065|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.57|||<|0.001|TWO_SIDED|95.0|1.25|1.9|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.90|1.25|<0.001
71117066|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.35|||<|0.001|TWO_SIDED|95.0|1.02|1.67|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.67|1.02|<0.001
71117067|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.22||||0.056|TWO_SIDED|95.0|-0.01|0.45|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.45|-0.01|0.056
71117068|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.04||||0.759|TWO_SIDED|95.0|-0.19|0.26|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.26|-0.19|0.759
71117069|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.23||||0.051|TWO_SIDED|95.0|0.0|0.45|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.45|-0.00|0.051
71117070|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.64|||<|0.001|TWO_SIDED|95.0|1.3|1.98|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.98|1.30|<0.001
71117071|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.52|||<|0.001|TWO_SIDED|95.0|1.18|1.85|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.85|1.18|<0.001
71117072|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.71|||<|0.001|TWO_SIDED|95.0|1.37|2.05|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.05|1.37|<0.001
71117073|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.52|||<|0.001|TWO_SIDED|95.0|1.19|1.86|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.86|1.19|<0.001
71117074|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.11||||0.342|TWO_SIDED|95.0|-0.12|0.35|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.35|-0.12|0.342
71117075|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.01||||0.943|TWO_SIDED|95.0|-0.24|0.23|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.23|-0.24|0.943
70853799|NCT04345367|141195680|OTHER||Estimate of difference|22.9|||||TWO_SIDED|95.0|16.0|29.9|||||Day 15. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||29.9|16.0|
70853800|NCT04345367|141195681|OTHER||Estimate of difference|17.3|||||TWO_SIDED|95.0|10.1|24.5|||||Week 4. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||24.5|10.1|
70941165|NCT02123797|141382184|SUPERIORITY|||||||0.0014|||||||Kruskal-Wallis|||Time from Initial Detection of Lesion to Invasive Staging Test||||0.0014
70941166|NCT02123797|141382184|SUPERIORITY|||||||0.0037|||||||Kruskal-Wallis|||Time from Initial Detection of Lesion to Definitive Treatment||||0.0037
70941167|NCT02123797|141382191|SUPERIORITY|||||||0.7506|||||||Log Rank|||||||0.7506
70941168|NCT02123797|141382191|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.54|TWO_SIDED|95.0|0.85|1.36|||Regression, Cox||Comparison is Multidisciplinary/Serial Care.|||1.36|0.85|0.54
71117076|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.18||||0.126|TWO_SIDED|95.0|-0.05|0.42|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.42|-0.05|0.126
71117077|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.63|||<|0.001|TWO_SIDED|95.0|1.27|1.98|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.98|1.27|<0.001
71117078|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.5|||<|0.001|TWO_SIDED|95.0|1.15|1.86|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.86|1.15|<0.001
71117079|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.64|||<|0.001|TWO_SIDED|95.0|1.29|2.0|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.00|1.29|<0.001
70941169|NCT02123797|141382192|SUPERIORITY|||||||0.4847|||||||Log Rank|||||||0.4847
70941170|NCT02123797|141382192|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.51|TWO_SIDED|95.0|0.87|1.43|||Regression, Cox||Comparison is Multidisciplinary/Serial Care Patients Not Presented in Conference|||1.43|0.87|0.51
71077071|NCT02494401|141663794|SUPERIORITY|||||||0.54||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.54
71077072|NCT02494401|141663794|SUPERIORITY|||||||0.33||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.33
70941171|NCT02123797|141382192|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.51|TWO_SIDED|95.0|0.84|1.67|||Regression, Cox||Comparison is Serial Care Patients Presented in Conference/Serial Care Patients Not Presented in Conference|||1.67|0.84|0.51
71077073|NCT02494401|141663795|SUPERIORITY|||||||0.59||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.59
71077074|NCT02494401|141663795|SUPERIORITY|||||||0.25||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.25
71077075|NCT02494401|141663795|SUPERIORITY|||||||0.12||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.12
70941172|NCT02123797|141382193|SUPERIORITY|||||||0.9874|||||||Log Rank|||||||0.9874
71077076|NCT02494401|141663796|SUPERIORITY|||||||0.51||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.51
71077077|NCT02494401|141663796|SUPERIORITY|||||||0.93||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.93
71077078|NCT02494401|141663796|SUPERIORITY|||||||0.84||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.84
71077079|NCT02494401|141663797|SUPERIORITY|||||||0.83||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.83
71077080|NCT02494401|141663797|SUPERIORITY|||||||0.27||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.27
71077081|NCT02494401|141663797|SUPERIORITY|||||||0.18||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.18
71077082|NCT02494401|141663798|SUPERIORITY|||||||0.64||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.64
71077083|NCT02494401|141663798|SUPERIORITY|||||||0.8||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.8
71077084|NCT02494401|141663798|SUPERIORITY|||||||0.09||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.09
71077085|NCT02494401|141663799|SUPERIORITY|||||||0.73||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.73
71077086|NCT02494401|141663799|SUPERIORITY|||||||0.82||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.82
71077087|NCT02494401|141663799|SUPERIORITY|||||||0.04||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.04
71077088|NCT02494401|141663800|SUPERIORITY|||||||0.95||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.95
71077089|NCT02494401|141663800|SUPERIORITY|||||||0.87||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.87
71077090|NCT02494401|141663800|SUPERIORITY|||||||0.63||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.63
71077091|NCT02494401|141663801|SUPERIORITY|||||||0.05||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.05
71077092|NCT02494401|141663801|SUPERIORITY|||||||0.62||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.62
71077093|NCT02494401|141663801|SUPERIORITY|||||||0.7||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.7
71077094|NCT02494401|141663802|SUPERIORITY|||||||0.29||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.29
71077095|NCT02494401|141663802|SUPERIORITY|||||||0.58||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.58
71077096|NCT02494401|141663802|SUPERIORITY|||||||0.49||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.49
71077097|NCT02494401|141663803|SUPERIORITY|||||||0.87||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.87
71077098|NCT02494401|141663803|SUPERIORITY|||||||0.89||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.89
71077099|NCT02494401|141663803|SUPERIORITY|||||||0.82||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.82
71077100|NCT02227368|141663826|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.3441|TWO_SIDED|95.0|-0.4|0.1|||t-test, 2 sided||Difference is Ticagrelor - Aspirin. LOCF was used for missing data imputation.|||0.1|-0.4|0.3441
71077101|NCT02227368|141663827|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.6186|TWO_SIDED|95.0|-0.4|0.6|||t-test, 2 sided||Difference is Ticagrelor - Aspirin. LOCF was used for missing data imputation.|||0.6|-0.4|0.6186
71077102|NCT04494425|141663832|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.52|0.75|||Log Rank|The analysis was performed using the stratified log-rank test.|HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for prior cyclin-dependent kinase (CDK)4/6 inhibitor use (yes versus no) and HER2 IHC expression (IHC 1+ versus IHC 2+/ISH-) and ties handled by Efron approach.|||0.75|0.52|<0.0001
71077103|NCT02412878|141663863|SUPERIORITY||Odds Ratio (OR)|2.485|||<|0.0001|TWO_SIDED|95.0|1.716|3.598||Progression-free survival, overall response, and overall survival were tested using a fixed sequence hierarchical testing procedure to control the family-wise type I error rate below one-sided 0.025 level.|Cochran-Mantel-Haenszel|One-sided p-value from CMH test stratified by the randomization factors (ISS stage at study entry, refractory to bortezomib treatment, and age).|Odds ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was calculated using the Mantel-Haenszel method stratified by the randomization stratification factors.|||3.598|1.716|< 0.0001
71077104|NCT02412878|141663863|SUPERIORITY||Odds Ratio (OR)|2.466|||<|0.0001|TWO_SIDED|95.0|1.707|3.563|||Fisher Exact||Odds ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was calculated using the Mantel-Haenszel method.|||3.563|1.707|<0.0001
71078848|NCT01964716|141665735|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.06|||||TWO_SIDED|97.5|0.82|1.36||||||Serotype 6B: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.36|0.82|
71117080|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.53|||<|0.001|TWO_SIDED|95.0|1.18|1.89|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.89|1.18|<0.001
70853801|NCT04345367|141195681|OTHER||Estimate of difference|13.0|||||TWO_SIDED|95.0|6.0|20.1|||||Week 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||20.1|6.0|
70853802|NCT04345367|141195681|OTHER||Estimate of difference|4.4|||||TWO_SIDED|95.0|-2.5|11.4|||||Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.4|-2.5|
71077105|NCT02412878|141663864|SUPERIORITY||Hazard Ratio (HR)|0.693||||0.0014|TWO_SIDED|95.0|0.544|0.883||Progression-free survival, overall response rate, and overall survival were tested using a fixed sequence hierarchical testing procedure to control the family-wise type I error rate below one-sided 0.025 level.|Log Rank|One-sided stratified log-rank test, stratified by the randomization factors (ISS stage at study entry, refractory to bortezomib treatment, and age).|Hazard ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was estimated using a Cox proportional hazards model stratified by the randomization stratification factors.|To ensure proper control of type I error, analysis of PFS was performed under a group sequential design framework with the stopping boundaries constructed using the Lan-DeMets spending function with an O'Brien-Fleming approach. The inferential comparison between the 2 treatment groups for PFS used the 1-sided log-rank test stratified by the randomization stratification factors. A 1-sided p-value was compared against the prespecified adjusted alpha value of 0.011 to determine significance.||0.883|0.544|0.0014
71117081|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.1||||0.453|TWO_SIDED|95.0|-0.15|0.34|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.34|-0.15|0.453
71117082|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.03||||0.816|TWO_SIDED|95.0|-0.28|0.22|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.22|-0.28|0.816
71117083|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.11||||0.384|TWO_SIDED|95.0|-0.14|0.36|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.36|-0.14|0.384
71117084|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.55|||<|0.001|TWO_SIDED|95.0|1.19|1.91|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.91|1.19|<0.001
71117085|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.46|||<|0.001|TWO_SIDED|95.0|1.1|1.82|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.82|1.10|<0.001
71117086|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.61|||<|0.001|TWO_SIDED|95.0|1.25|1.97|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.97|1.25|<0.001
71117087|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.46|||<|0.001|TWO_SIDED|95.0|1.1|1.82|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.82|1.10|<0.001
70853803|NCT04345367|141195681|OTHER||Estimate of difference|3.6|||||TWO_SIDED|95.0|-3.4|10.5|||||Week 16. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||10.5|-3.4|
70853804|NCT04345367|141195681|OTHER||Estimate of difference|2.0|||||TWO_SIDED|95.0|-4.9|9.0|||||Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||9.0|-4.9|
70941173|NCT02123797|141382193|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.8|TWO_SIDED|95.0|0.82|1.29|||Regression, Cox||Comparison is Multidisciplinary/Serial Care|||1.29|0.82|0.80
70941174|NCT02123797|141382194|SUPERIORITY|||||||0.5377|||||||Log Rank|||||||0.5377
71077106|NCT02412878|141663864|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0033|TWO_SIDED|95.0|0.567|0.913|||Log Rank|One-sided unstratified log-rank test|Hazard ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was estimated using an unstratified Cox proportional hazards model.|||0.913|0.567|0.0033
71077107|NCT02412878|141663865|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.107|TWO_SIDED|95.0|0.563|1.138||Progression-free survival, overall response, and overall survival were tested using a fixed sequence hierarchical testing procedure to control the family-wise type I error rate below one-sided 0.025 level.|Log Rank|One-sided stratified log-rank test, stratified by the randomization factors (ISS stage at study entry, refractory to bortezomib treatment, and age).|Hazard ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was estimated using a Cox proportional hazards model stratified by the randomization stratification factors.|||1.138|0.563|0.1070
71077108|NCT02412878|141663865|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.1326|TWO_SIDED|95.0|0.578|1.164|||Log Rank|One-sided unstratified log-rank test|Hazard ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was estimated using an unstratified Cox proportional hazards model.|||1.164|0.578|0.1326
71077109|NCT05025332|141663904|OTHER|||||||0.0039|||||||Wilcoxon Signed rank|null median = 4, not 0||Descriptive statistics were used to summarize the data. For total scores, waterfall plots and histograms/bar charts were created at the EOT visit with plots for all participants.||||.0039
71077110|NCT05025332|141663905|OTHER|||||||0.0234|||||||Wilcoxon Signed rank|null median = 4, not 0||Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants.||||0.0234
71077111|NCT05025332|141663906|OTHER|Change from baseline||||||0.0313|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.0313
70853805|NCT04345367|141195681|OTHER||Estimate of difference|5.0|||||TWO_SIDED|95.0|-1.9|11.9|||||Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.9|-1.9|
70853806|NCT04345367|141195683|OTHER||Least square mean difference|-9.3|||||TWO_SIDED|95.0|-14.0|-4.6|||||Week 2. Analysis was performed using Mixed Model Repeated Measure (MMRM) with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-4.6|-14.0|
71077112|NCT05025332|141663907|OTHER|Change from baseline||||||0.0039|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.0039
71077113|NCT05025332|141663908|OTHER|change from baseline||||||0.1934|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.1934
71077114|NCT05025332|141663909|OTHER|Change from baseline||||||0.748|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.7480
71077115|NCT05025332|141663910|OTHER|Change from baseline||||||0.3203|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.3203
71077116|NCT05025332|141663911|OTHER|change from baseline||||||0.3574|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.3574
71077117|NCT05025332|141663912|OTHER|Change from baseline||||||0.4131|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.4131
71077118|NCT05025332|141663913|OTHER|change from baseline||||||0.9063|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.9063
71077119|NCT05025332|141663914|OTHER|Change from baseline||||||1|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||1.00
71077120|NCT05025332|141663915|OTHER|Change from baseline||||||0.7002|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.7002
71077121|NCT05025332|141663916|OTHER|Change from baseline||||||0.375|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.3750
71077122|NCT05025332|141663917|OTHER|||||||0.7695|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.7695
71077123|NCT05025332|141663918|OTHER|||||||0.2402|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.2402
71117088|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.09||||0.483|TWO_SIDED|95.0|-0.16|0.34|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.34|-0.16|0.483
71117089|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.0||||0.991|TWO_SIDED|95.0|-0.25|0.25|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.25|-0.25|0.991
71117090|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.16||||0.228|TWO_SIDED|95.0|-0.1|0.41|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.41|-0.10|0.228
71117091|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.48|||<|0.001|TWO_SIDED|95.0|1.1|1.85|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.85|1.10|<0.001
71117092|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.32|||<|0.001|TWO_SIDED|95.0|0.94|1.69|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.69|0.94|<0.001
70853807|NCT04345367|141195683|OTHER||Least square mean difference|-12.5|||||TWO_SIDED|95.0|-17.4|-7.6|||||Week 4. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-7.6|-17.4|
70853808|NCT04345367|141195683|OTHER||Least square mean difference|-11.1|||||TWO_SIDED|95.0|-15.6|-6.6|||||Week 8. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-6.6|-15.6|
70853809|NCT04345367|141195683|OTHER||Least square mean difference|-9.4|||||TWO_SIDED|95.0|-13.7|-5.1|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-5.1|-13.7|
71077124|NCT01306214|141663919|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|97.5|-0.61|-0.27||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 18 was the first step in each hierarchical sequence.|ANCOVA|ANCOVA Model includes baseline HbA1c as a covariate and baseline eGFR, geographic region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of Empagliflozin 10 mg - Adjusted mean of placebo.|"For the primary endpoint, the testing of the superiority hypothesis versus placebo was:~Hypothesis test:~H0: No difference in change from baseline to Week 18 in HbA1c (%) between Empagliflozin 10 mg and placebo Ha: A difference in change from baseline to Week 18 in HbA1c (%) between Empagliflozin 10 mg and placebo"||-0.27|-0.61|<0.0001
71077125|NCT01306214|141663919|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.69|-0.35||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 18 was the first step in each hierarchical sequence.|ANCOVA|ANCOVA Model includes baseline HbA1c as a covariate and baseline eGFR, geographic region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of Empagliflozin 25 mg - Adjusted mean of placebo|"For the primary endpoint, the testing of the superiority hypothesis versus placebo was:~H0: No difference in change from baseline to Week 18 in HbA1c (%) between Empagliflozin 25 mg and placebo Ha: A difference in change from baseline to Week 18 in HbA1c (%) between Empagliflozin 25 mg and placebo"||-0.35|-0.69|<0.0001
71077126|NCT01306214|141663920|SUPERIORITY_OR_OTHER||Adjusted mean difference|-8.83|STANDARD_ERROR_OF_MEAN|3.05||0.004|TWO_SIDED|97.5|-15.69|-1.97||Hierarchical testing adjusted for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in insulin dose at week 52 was the second step in hierarchical sequence.|ANCOVA|Model - Covariates: baseline insulin daily dose,baseline HbA1c Fixed effects: baseline eGFR, region, baseline background medication, treatment|Estimated value = Adjusted mean of empagliflozin 10 mg - Adjusted mean of placebo|"Hypothesis test:~H0: No difference in change from baseline to Week 52 in insulin dose (IU/day) between Empagliflozin 10 mg and placebo Ha: A difference in change from baseline to Week 52 in insulin dose (IU/day) between Empagliflozin 10 mg and placebo"||-1.97|-15.69|0.004
71077127|NCT01306214|141663920|SUPERIORITY_OR_OTHER||Adjusted mean difference|-11.22|STANDARD_ERROR_OF_MEAN|3.05||0.0003|TWO_SIDED|97.5|-18.09|-4.36||Hierarchical testing adjusted for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in insulin dose at week 52 was the second step in hierarchical sequence.|ANCOVA|Model - Covariates: baseline insulin daily dose,baseline HbA1c Fixed effects: baseline eGFR, region, baseline background medication, treatment|Estimated value = Adjusted mean of Empagliflozin 25 mg - Adjusted mean of placebo.|"Hypothesis test:~H0: No difference in change from baseline to Week 52 in insulin dose (IU/day) between Empagliflozin 25 mg and placebo Ha : A difference in change from baseline to Week 52 in insulin dose (IU/day) between Empagliflozin 25 mg and placebo"||-4.36|-18.09|0.0003
71077128|NCT01306214|141663921|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.39|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001|TWO_SIDED|97.5|-3.54|-1.24||Hierarchical testing adjusted for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in body weight at week 52 was the third step in hierarchical sequence.|ANCOVA|Model includes baseline weight, baseline HbA1c as covariates and baseline eGFR, region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 10 mg - Adjusted mean of placebo|"Hypothesis test:~H0: No difference in change from baseline to Week 52 in body weight (kg) between Empagliflozin 10 mg and placebo Ha : A difference in change from baseline to Week 52 in body weight (kg) between Empagliflozin 10 mg and placebo"||-1.24|-3.54|<0.0001
71077129|NCT01306214|141663921|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.48|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001|TWO_SIDED|97.5|-3.63|-1.33||Hierarchical testing adjusted for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in body weight at week 52 was the third step in hierarchical sequence.|ANCOVA|Model includes baseline weight, baseline HbA1c as covariates and baseline eGFR, region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 25 mg - Adjusted mean of placebo|hypothesis test: H0: No difference in change from baseline to Week 52 in body weight (kg) between Empagliflozin 25 mg and placebo Ha: A difference in change from baseline to Week 52 in body weight (kg) between Empagliflozin 25 mg and placebo||-1.33|-3.63|<0.0001
71077130|NCT01306214|141663922|NON_INFERIORITY_OR_EQUIVALENCE|The non- inferiority margin was 0.3%, one-sided.|Adjusted mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|97.5|-0.62|-0.13||Hierarchical testing adjusted for multiple comparisons within each dose, alpha split between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 52 was the 4th step (non-inferiority) and 5th step (superiority).|ANCOVA|Model includes baseline HbA1c as covariate and baseline eGFR, geographical region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 10 mg - Adjusted mean of placebo|H0: Difference in change from baseline to Week 52 in HbA1c (%) between empagliflozin 10 mg and placebo \>0.3 Ha: Difference in change from baseline to Week 52 in HbA1c (%) between empagliflozin 10 mg and placebo ≤0.3||-0.13|-0.62|<0.0001
71117093|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.53|||<|0.001|TWO_SIDED|95.0|1.15|1.9|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.90|1.15|<0.001
71117094|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.4|||<|0.001|TWO_SIDED|95.0|1.03|1.78|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.78|1.03|<0.001
71117095|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.07||||0.587|TWO_SIDED|95.0|-0.19|0.33|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.33|-0.19|0.587
71117096|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.09||||0.517|TWO_SIDED|95.0|-0.35|0.17|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.17|-0.35|0.517
71117097|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.12||||0.36|TWO_SIDED|95.0|-0.14|0.38|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.38|-0.14|0.360
71117098|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.2|||<|0.001|TWO_SIDED|95.0|0.81|1.6|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.60|0.81|<0.001
71117099|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.17|||<|0.001|TWO_SIDED|95.0|0.78|1.57|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.57|0.78|<0.001
71117100|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.36|||<|0.001|TWO_SIDED|95.0|0.97|1.76|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.76|0.97|<0.001
71117101|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.17|||<|0.001|TWO_SIDED|95.0|0.77|1.56|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.56|0.77|<0.001
71117102|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.03||||0.811|TWO_SIDED|95.0|-0.24|0.31|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.31|-0.24|0.811
71117103|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.0||||0.977|TWO_SIDED|95.0|-0.27|0.28|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.28|-0.27|0.977
71117104|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.2||||0.164|TWO_SIDED|95.0|-0.08|0.47|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.47|-0.08|0.164
71117105|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.03|||<|0.001|TWO_SIDED|95.0|0.63|1.43|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.43|0.63|<0.001
71117106|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.0|||<|0.001|TWO_SIDED|95.0|0.6|1.4|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.40|0.60|<0.001
70853810|NCT04345367|141195683|OTHER||Least square mean difference|-6.9|||||TWO_SIDED|95.0|-10.9|-2.9|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-2.9|-10.9|
71117107|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.15|||<|0.001|TWO_SIDED|95.0|0.75|1.56|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.56|0.75|<0.001
71117108|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.06|||<|0.001|TWO_SIDED|95.0|0.66|1.46|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.46|0.66|<0.001
71117109|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.03||||0.846|TWO_SIDED|95.0|-0.31|0.25|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.25|-0.31|0.846
71117110|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.702|TWO_SIDED|95.0|-0.33|0.23|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.23|-0.33|0.702
71117111|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.1||||0.496|TWO_SIDED|95.0|-0.18|0.38|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.38|-0.18|0.496
71117112|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.81|||<|0.001|TWO_SIDED|95.0|0.41|1.22|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.22|0.41|<0.001
71117113|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.81|||<|0.001|TWO_SIDED|95.0|0.4|1.21|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.21|0.40|<0.001
70941175|NCT02123797|141382194|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.73|TWO_SIDED|95.0|0.83|1.34|||Regression, Cox||Comparison is Multidisciplinary/Serial Care Patients Not Presented in Conference|||1.34|0.83|0.73
71117114|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.86|||<|0.001|TWO_SIDED|95.0|0.46|1.26|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.26|0.46|<0.001
71117115|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.92|||<|0.001|TWO_SIDED|95.0|0.52|1.33|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.33|0.52|<0.001
71117116|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.11||||0.441|TWO_SIDED|95.0|-0.39|0.17|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.17|-0.39|0.441
71117117|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.12||||0.408|TWO_SIDED|95.0|-0.4|0.16|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.16|-0.40|0.408
71117118|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.06||||0.652|TWO_SIDED|95.0|-0.35|0.22|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.22|-0.35|0.652
71117119|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.61||||0.003|TWO_SIDED|95.0|0.21|1.02|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.02|0.21|0.003
71117120|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.55||||0.007|TWO_SIDED|95.0|0.15|0.95|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.95|0.15|0.007
70853811|NCT04345367|141195683|OTHER||Least square mean difference|-5.3|||||TWO_SIDED|95.0|-9.0|-1.7|||||Week 20. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-1.7|-9.0|
70853812|NCT04345367|141195683|OTHER||Least square mean difference|-3.4|||||TWO_SIDED|95.0|-7.1|0.4|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.4|-7.1|
70853813|NCT04345367|141195684|OTHER||Least square mean difference|-11.0|||||TWO_SIDED|95.0|-14.5|-7.6|||||Week 2. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-7.6|-14.5|
71077131|NCT01306214|141663922|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.11||0.0005|TWO_SIDED|97.5|-0.62|-0.13||Hierarchical testing adjusted for multiple comparisons within each dose, alpha split between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 52 was the 4th step (non-inferiority) and 5th step (superiority).|ANCOVA|Model includes baseline HbA1c as covariate and baseline eGFR, geographical region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 10 mg - Adjusted mean of placebo|"Hypothesis test:~H0: No difference in change from baseline to Week 52 in HbA1c (%) between Empagliflozin 10 mg and placebo Ha : A difference in change from baseline to Week 52 in HbA1c (%) between Empagliflozin 10 mg and placebo"||-0.13|-0.62|0.0005
71117121|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.69|||<|0.001|TWO_SIDED|95.0|0.29|1.1|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.10|0.29|<0.001
71117122|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.7|||<|0.001|TWO_SIDED|95.0|0.29|1.1|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.10|0.29|<0.001
71117123|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.08||||0.567|TWO_SIDED|95.0|-0.36|0.2|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.20|-0.36|0.567
71117124|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.14||||0.315|TWO_SIDED|95.0|-0.42|0.14|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.14|-0.42|0.315
71117125|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.0||||0.997|TWO_SIDED|95.0|-0.28|0.28|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.28|-0.28|0.997
71117126|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.38||||0.056|TWO_SIDED|95.0|-0.01|0.77|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.77|-0.01|0.056
71117127|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.39||||0.047|TWO_SIDED|95.0|0.01|0.78|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.78|0.01|0.047
71117128|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.56||||0.005|TWO_SIDED|95.0|0.17|0.95|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.95|0.17|0.005
71117129|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.53||||0.007|TWO_SIDED|95.0|0.14|0.92|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.92|0.14|0.007
70853814|NCT04345367|141195684|OTHER||Least square mean difference|-12.8|||||TWO_SIDED|95.0|-16.0|-9.5|||||Week 4. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-9.5|-16.0|
70853815|NCT04345367|141195684|OTHER||Least square mean difference|-10.2|||||TWO_SIDED|95.0|-13.6|-6.8|||||Week 8. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-6.8|-13.6|
70941176|NCT02123797|141382194|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.73|TWO_SIDED|95.0|0.82|1.57|||Regression, Cox||Comparison is Serial Care Patients Presented in Conference/Serial Care Patients Not Presented in Conference|||1.57|0.82|0.73
70941177|NCT01072396|141382314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.0087||95.0|0.02|0.11||Based on mixed effect model with repeated measures (MMRM) with fixed categorical effects for treatment, period and random effect for patient. Period baseline and patient baseline (average of two period baselines) were covariates in the model.|Mixed Models Analysis|Restricted maximum likelihood (REML) based MMRM||Placebo versus Tiotropium - crossover design||0.11|0.02|0.0087
71077132|NCT01306214|141663922|NON_INFERIORITY_OR_EQUIVALENCE|The non- inferiority margin was 0.3%, one-sided.|Adjusted mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|97.5|-0.7|-0.22||Hierarchical testing adjusted for multiple comparisons within each dose, alpha split between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 52 was the 4th step (non-inferiority) and 5th step (superiority).|ANCOVA|Model includes baseline HbA1c as covariate and baseline eGFR, geographical region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 25 mg - Adjusted mean of placebo|H013: Difference in change from baseline to Week 52 in HbA1c (%) between empagliflozin 25 mg and placebo \>0.3 Ha13: Difference in change from baseline to Week 52 in HbA1c (%) between empagliflozin 25 mg and placebo ≤0.3||-0.22|-0.70|<0.0001
71117130|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.15||||0.276|TWO_SIDED|95.0|-0.42|0.12|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.12|-0.42|0.276
71117131|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.14||||0.318|TWO_SIDED|95.0|-0.41|0.13|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.13|-0.41|0.318
71117132|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.03||||0.849|TWO_SIDED|95.0|-0.25|0.3|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.30|-0.25|0.849
71117133|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.29||||0.138|TWO_SIDED|95.0|-0.09|0.66|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.66|-0.09|0.138
71117134|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.31||||0.111|TWO_SIDED|95.0|-0.07|0.68|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.68|-0.07|0.111
71117135|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.42||||0.031|TWO_SIDED|95.0|0.04|0.79|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.79|0.04|0.031
71117136|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.49||||0.011|TWO_SIDED|95.0|0.11|0.87|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.87|0.11|0.011
71117137|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.2||||0.135|TWO_SIDED|95.0|-0.47|0.06|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.06|-0.47|0.135
71117138|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.18||||0.175|TWO_SIDED|95.0|-0.44|0.08|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.08|-0.44|0.175
71117139|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.07||||0.59|TWO_SIDED|95.0|-0.34|0.19|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.19|-0.34|0.590
71117140|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.15||||0.402|TWO_SIDED|95.0|-0.2|0.49|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.49|-0.20|0.402
71117141|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.2||||0.261|TWO_SIDED|95.0|-0.15|0.54|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.54|-0.15|0.261
71117142|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.26||||0.134|TWO_SIDED|95.0|-0.08|0.61|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.61|-0.08|0.134
71117143|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.38||||0.031|TWO_SIDED|95.0|0.03|0.72|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.72|0.03|0.031
71117144|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.23||||0.061|TWO_SIDED|95.0|-0.47|0.01|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.01|-0.47|0.061
71117145|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.18||||0.138|TWO_SIDED|95.0|-0.42|0.06|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.06|-0.42|0.138
71117146|NCT01559259|141740580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.11||||0.353|TWO_SIDED|95.0|-0.35|0.13|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.13|-0.35|0.353
71117147|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.88||||0.006|TWO_SIDED|95.0|0.25|1.51|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.51|0.25|0.006
71117148|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.69||||0.03|TWO_SIDED|95.0|0.07|1.31|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.31|0.07|0.030
71117149|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.81||||0.012|TWO_SIDED|95.0|0.17|1.44|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.44|0.17|0.012
71117150|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.38||||0.237|TWO_SIDED|95.0|-0.25|1.01|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.01|-0.25|0.237
71117151|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.5||||0.024|TWO_SIDED|95.0|0.07|0.93|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.93|0.07|0.024
70853816|NCT04345367|141195684|OTHER||Least square mean difference|-7.3|||||TWO_SIDED|95.0|-10.5|-4.1|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-4.1|-10.5|
70853817|NCT04345367|141195684|OTHER||Least square mean difference|-6.1|||||TWO_SIDED|95.0|-9.3|-3.0|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-3.0|-9.3|
71117152|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.31||||0.15|TWO_SIDED|95.0|-0.11|0.73|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.73|-0.11|0.150
71117153|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.43||||0.054|TWO_SIDED|95.0|-0.01|0.86|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.86|-0.01|0.054
71117154|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.89|||<|0.001|TWO_SIDED|95.0|1.92|3.85|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.85|1.92|<0.001
71117155|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.52|||<|0.001|TWO_SIDED|95.0|1.56|3.47|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.47|1.56|<0.001
71117156|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.51|||<|0.001|TWO_SIDED|95.0|1.54|3.47|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.47|1.54|<0.001
71117157|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.76|||<|0.001|TWO_SIDED|95.0|0.79|2.72|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.72|0.79|<0.001
71117158|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.13|||<|0.001|TWO_SIDED|95.0|0.47|1.79|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.79|0.47|<0.001
71117159|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.76||||0.021|TWO_SIDED|95.0|0.11|1.41|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.41|0.11|0.021
71117160|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.75||||0.027|TWO_SIDED|95.0|0.09|1.41|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.41|0.09|0.027
71117161|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.75|||<|0.001|TWO_SIDED|95.0|3.65|5.84|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.84|3.65|<0.001
71117162|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.21|||<|0.001|TWO_SIDED|95.0|3.13|5.29|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.29|3.13|<0.001
71117163|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.47|||<|0.001|TWO_SIDED|95.0|3.37|5.56|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.56|3.37|<0.001
71117164|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.92|||<|0.001|TWO_SIDED|95.0|2.83|5.02|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.02|2.83|<0.001
71117165|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.83||||0.031|TWO_SIDED|95.0|0.08|1.58|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.58|0.08|0.031
71117166|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.29||||0.442|TWO_SIDED|95.0|-0.44|1.02|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.02|-0.44|0.442
71117167|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.55||||0.152|TWO_SIDED|95.0|-0.2|1.3|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.30|-0.20|0.152
71117168|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.62|||<|0.001|TWO_SIDED|95.0|4.52|6.72|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.72|4.52|<0.001
71117169|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.04|||<|0.001|TWO_SIDED|95.0|3.96|6.13|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.13|3.96|<0.001
70853818|NCT04345367|141195684|OTHER||Least square mean difference|-4.9|||||TWO_SIDED|95.0|-8.2|-1.7|||||Week 20. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-1.7|-8.2|
71078849|NCT01964716|141665735|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|0.94|||||TWO_SIDED|97.5|0.82|1.08||||||Serotype 7F: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.08|0.82|
70853819|NCT04345367|141195684|OTHER||Least square mean difference|-3.3|||||TWO_SIDED|95.0|-6.6|0.1|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.1|-6.6|
70853820|NCT04345367|141195685|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.4|0.4|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.4|-0.4|
70853821|NCT04345367|141195685|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.3|0.5|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.5|-0.3|
70853822|NCT04345367|141195685|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.3|0.6|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.6|-0.3|
70853823|NCT04345367|141195686|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.3|0.3|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.3|-0.3|
71117170|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.4|||<|0.001|TWO_SIDED|95.0|4.3|6.5|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.50|4.30|<0.001
71117171|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.88|||<|0.001|TWO_SIDED|95.0|3.78|5.98|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.98|3.78|<0.001
71117172|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.74||||0.055|TWO_SIDED|95.0|-0.01|1.49|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.49|-0.01|0.055
71117173|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.16||||0.666|TWO_SIDED|95.0|-0.57|0.9|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.90|-0.57|0.666
71117174|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.51||||0.181|TWO_SIDED|95.0|-0.24|1.27|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.27|-0.24|0.181
71117175|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.86|||<|0.001|TWO_SIDED|95.0|4.71|7.01|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||7.01|4.71|<0.001
71117176|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.43|||<|0.001|TWO_SIDED|95.0|4.29|6.57|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.57|4.29|<0.001
71117177|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.79|||<|0.001|TWO_SIDED|95.0|4.64|6.94|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.94|4.64|<0.001
71117178|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.34|||<|0.001|TWO_SIDED|95.0|4.19|6.5|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.50|4.19|<0.001
71117179|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.52||||0.2|TWO_SIDED|95.0|-0.27|1.31|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.31|-0.27|0.200
71117180|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.08||||0.831|TWO_SIDED|95.0|-0.69|0.85|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.85|-0.69|0.831
71117181|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.45||||0.268|TWO_SIDED|95.0|-0.34|1.24|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.24|-0.34|0.268
71117182|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.73|||<|0.001|TWO_SIDED|95.0|4.54|6.91|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.91|4.54|<0.001
71117183|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.31|||<|0.001|TWO_SIDED|95.0|4.13|6.48|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.48|4.13|<0.001
71117184|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.6|||<|0.001|TWO_SIDED|95.0|4.41|6.78|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.78|4.41|<0.001
71117185|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.35|||<|0.001|TWO_SIDED|95.0|4.17|6.54|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.54|4.17|<0.001
71117186|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.37||||0.367|TWO_SIDED|95.0|-0.44|1.19|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.19|-0.44|0.367
71117187|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.908|TWO_SIDED|95.0|-0.84|0.75|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.75|-0.84|0.908
71077133|NCT01306214|141663922|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|97.5|-0.7|-0.22||Hierarchical testing adjusted for multiple comparisons within each dose, alpha split between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 52 was the 4th step (non-inferiority) and 5th step (superiority).|ANCOVA|Model includes baseline HbA1c as covariate and baseline eGFR, geographical region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 25 mg - Adjusted mean of placebo|"Hypothesis test:~H0: No difference in change from baseline to Week 52 in HbA1c (%) between Empagliflozin 25 mg and placebo Ha : A difference in change from baseline to Week 52 in HbA1c (%) between Empagliflozin 25 mg and placebo"||-0.22|-0.70|<0.0001
71077134|NCT01760447|141663934|SUPERIORITY||Least Squares Mean Difference|-0.49|||=|0.018|TWO_SIDED|95.0|-0.9|-0.09|||Mixed Models Analysis|||"The Least Squares (LS) Mean for the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||-0.09|-0.90|= 0.018
70853824|NCT04345367|141195686|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.2|0.5|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.5|-0.2|
71077135|NCT01760447|141663935|OTHER||Difference in Percentage|-1.3|||||TWO_SIDED|95.0|-13.9|11.3|||||The Miettinen and Nurminen methodology was used to calculate the difference and 95% confidence interval.|"The percentage of participants who experienced ≥1 adverse event for the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||11.3|-13.9|
70941178|NCT01072396|141382315|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.0685||||0.067||95.0|0.9953|1.147||Based on mixed effect model with repeated measures (MMRM) with fixed categorical effects for treatment, period and random effect for patient. Period baseline and patient baseline (average of two period baselines) were covariates in the model.|Mixed Models Analysis|Restricted maximum likelihood (REML) based MMRM||Placebo versus Tiotropium - corssover design||1.1470|0.9953|0.0670
70941179|NCT01072396|141382316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2059||||0.2417||95.0|-0.5527|0.1408||Based on mixed effect model with repeated measures (MMRM) with fixed categorical effects for treatment, period and random effect for patient. Period baseline and patient baseline (average of two period baselines) were covariates in the model.|Mixed Models Analysis|Restricted maximum likelihood (REML) based MMRM||Placebo versus Tiotropium - corssover design||0.1408|-0.5527|0.2417
70941180|NCT01106586|141382326|NON_INFERIORITY_OR_EQUIVALENCE|A total of 700 HIV-1 infected participants, randomized in a 1:1 ratio to 2 groups would achieve at least 95% power to establish noninferiority in Week 48 response (HIV-1 RNA \< 50 copies/mL per the FDA-defined snapshot analysis) rate difference between the 2 groups. For sample size and power computation, it was assumed that both treatment groups have a response rate of 0.795, a noninferiority margin of 0.12, and that the significance level of the test is at a one-sided, 0.025 level.|Difference in response rates|3.0|||||TWO_SIDED|95.2|-1.9|7.8|||||To preserve the overall alpha level: 0.05, accounting for 2 interim analyses for Independent Data Monitoring Committee meetings, the 95.2% CI was computed using normal approximation stratified by baseline HIV-1 RNA (≤ 100,000 or \> 100,000 copies/mL).|The null hypothesis was that the Stribild group is at least 12% worse than the ATV/r + Truvada group with respect to percentage of participants achieving HIV-1 RNA \< 50 copies/mL (response rate as defined by the snapshot analysis algorithm) at Week 48; the alternative hypothesis was that the response rate in the Stribild group is less than 12% worse than that in the ATV/r + Truvada Group.||7.8|-1.9|
70941181|NCT00938041|141382340|SUPERIORITY_OR_OTHER||percentage of participants|25.0|||||TWO_SIDED|95.0|10.0|40.0|||||The estimated value reflects the percentage of participants with complete response. Percentages are calculated using the number of participants in the ITT-Exposed Population as the denominator.|||40|10|
70941182|NCT00938041|141382340|SUPERIORITY_OR_OTHER||percentage of participants|25.0|||||TWO_SIDED|95.0|10.0|40.0|||||The estimated value reflects the percentage of participants with confirmed complete response. Percentages are calculated using the number of participants in the ITT-Exposed Population as the denominator.|||40|10|
70941183|NCT00404547|141382380|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||This is an analysis of the change in Asthma Control Questionnaire (ACQ) after 12 weeks of treatment.||||<0.0001
71117188|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.25||||0.553|TWO_SIDED|95.0|-0.57|1.06|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.06|-0.57|0.553
71117189|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.45|||<|0.001|TWO_SIDED|95.0|4.22|6.68|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.68|4.22|<0.001
71117190|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.1|||<|0.001|TWO_SIDED|95.0|3.88|6.31|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.31|3.88|<0.001
71117191|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.42|||<|0.001|TWO_SIDED|95.0|4.19|6.66|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.66|4.19|<0.001
70941184|NCT01614899|141382400|SUPERIORITY||LS Mean difference|-4.8||||0.05|TWO_SIDED|95.0|-9.52|0.0|||Mixed Model for Repeated Measures|||||0.00|-9.52|0.050
70941185|NCT01614899|141382400|SUPERIORITY||LS Mean difference|-4.2||||0.08|TWO_SIDED|95.0|-8.91|0.5|||Mixed Model for Repeated Measures|||||0.50|-8.91|0.080
70941186|NCT01614899|141382401|SUPERIORITY||LS Mean difference|-0.08||||0.594|TWO_SIDED|95.0|-0.354|0.203|||Mixed Model for Repeated Measures|||||0.203|-0.354|0.594
70941187|NCT01614899|141382401|SUPERIORITY||LS Mean difference|-0.18||||0.199|TWO_SIDED|95.0|-0.453|0.095|||Mixed Model for Repeated Measures|||||0.095|-0.453|0.199
70941188|NCT01614899|141382402|SUPERIORITY||LS Mean difference|-1.1||||0.143|TWO_SIDED|95.0|-2.6|0.38|||Mixed Model for Repeated Measures|||||0.38|-2.60|0.143
70941189|NCT01614899|141382402|SUPERIORITY||LS Mean difference|-1.9||||0.01|TWO_SIDED|95.0|-3.4|-0.46|||Mixed Model for Repeated Measures|||||-0.46|-3.40|0.010
70941190|NCT01614899|141382403|SUPERIORITY||LS Mean difference|-1.0||||0.116|TWO_SIDED|95.0|-2.27|0.25|||Mixed Model for Repeated Measures|||||0.25|-2.27|0.116
70941191|NCT01614899|141382403|SUPERIORITY||LS Mean difference|-0.5||||0.388|TWO_SIDED|95.0|-1.8|0.7|||Mixed Model for Repeated Measures|||||0.70|-1.80|0.388
70941192|NCT01614899|141382404|SUPERIORITY||LS Mean difference|-2.5||||0.036|TWO_SIDED|95.0|-4.87|-0.17|||Mixed Model for Repeated Measures|||||-0.17|-4.87|0.036
70941193|NCT01614899|141382404|SUPERIORITY||LS Mean difference|-1.6||||0.174|TWO_SIDED|95.0|-3.93|0.72|||Mixed Model for Repeated Measures|||||0.72|-3.93|0.174
71117192|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.17|||<|0.001|TWO_SIDED|95.0|3.94|6.4|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.40|3.94|<0.001
71117193|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.28||||0.518|TWO_SIDED|95.0|-0.57|1.12|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.12|-0.57|0.518
71117194|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.07||||0.86|TWO_SIDED|95.0|-0.9|0.75|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.75|-0.90|0.860
70941194|NCT02350127|141382408|SUPERIORITY||Mean Difference (Final Values)|1.79|STANDARD_ERROR_OF_MEAN|1.22||0.14|TWO_SIDED|95.0|-0.59|4.18|||Mixed Models Analysis|||adjusted for participant baseline MOCA, robust VCE||4.18|-0.59|0.14
70853825|NCT04345367|141195686|OTHER||Least square mean difference|0.2|||||TWO_SIDED|95.0|-0.1|0.6|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.6|-0.1|
70853826|NCT04345367|141195687|OTHER||Least square mean difference|-2.0|||||TWO_SIDED|95.0|-2.6|-1.3|||||Week 2. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-1.3|-2.6|
70853827|NCT04345367|141195687|OTHER||Least square mean difference|-1.0|||||TWO_SIDED|95.0|-1.6|-0.4|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.4|-1.6|
70853828|NCT04345367|141195687|OTHER||Least square mean difference|-0.8|||||TWO_SIDED|95.0|-1.4|-0.2|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.2|-1.4|
71077136|NCT01760447|141663936|OTHER||Difference in Percentage|-0.5|||||TWO_SIDED|95.0|-6.2|5.0|||||The Miettinen and Nurminen methodology was used to calculate the difference and 95% confidence interval.|"The percentage of participants who discontinued study drug due to experiencing an adverse event for the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||5.0|-6.2|
71077137|NCT01760447|141663937|OTHER||Difference in Percentage|2.9|||||TWO_SIDED|95.0|-8.9|14.4|||||The Miettinen and Nurminen methodology was used to calculate the difference and 95% confidence interval.|"The percentage of participants who experienced ≥1 adverse event for the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||14.4|-8.9|
71077138|NCT01760447|141663938|OTHER||Difference in Percentage|-2.1|||||TWO_SIDED|95.0|-10.1|5.8|||||The Miettinen and Nurminen methodology was used to calculate the difference and 95% confidence interval.|"The percentage of participants who discontinued study drug due to experiencing an adverse event for the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||5.8|-10.1|
71077139|NCT01760447|141663940|SUPERIORITY||Least Squares Mean Difference|-10.8|||=|0.159|TWO_SIDED|95.0|-25.9|4.3|||Mixed Models Analysis|||"The Least Squares (LS) Mean for the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||4.3|-25.9|= 0.159
71077140|NCT01760447|141663942|SUPERIORITY||Difference in Percentage|16.0||||0.017|TWO_SIDED|95.0|2.9|28.9|||Miettinen and Nurminen|||"The percentage of participants with A1C at the A1C goal (\<7.0%) in the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled. For estimating the treatment difference, when the A1C result for a participant at Week 20 was not available, a multiple imputation method was used to impute whether the participant had met the goal."||28.9|2.9|0.017
70853829|NCT04345367|141195687|OTHER||Least square mean difference|-0.6|||||TWO_SIDED|95.0|-1.2|0.0|||||Week 20. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.0|-1.2|
70853830|NCT04345367|141195687|OTHER||Least square mean difference|-0.3|||||TWO_SIDED|95.0|-1.0|0.4|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.4|-1.0|
70853831|NCT04345367|141195688|OTHER||Least square mean difference|0.818|||||TWO_SIDED|95.0|-1.22|2.856|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||2.856|-1.220|
70853832|NCT04345367|141195688|OTHER||Least square mean difference|2.093|||||TWO_SIDED|95.0|-0.081|4.267|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||4.267|-0.081|
70853833|NCT04345367|141195688|OTHER||Least square mean difference|-0.816|||||TWO_SIDED|95.0|-2.914|1.281|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||1.281|-2.914|
70853834|NCT04345367|141195689|OTHER||Least square mean difference|-1.6|||||TWO_SIDED|95.0|-2.5|-0.7|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.7|-2.5|
70853835|NCT04345367|141195689|OTHER||Least square mean difference|-1.4|||||TWO_SIDED|95.0|-2.2|-0.5|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.5|-2.2|
70853836|NCT04345367|141195689|OTHER||Least square mean difference|-0.4|||||TWO_SIDED|95.0|-1.3|0.5|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.5|-1.3|
71077141|NCT01760447|141663943|SUPERIORITY||Difference in Percentage|12.2||||0.049|TWO_SIDED|95.0|0.0|24.8|||Miettinen and Nurminen|||"The percentage of participants with A1C at the A1C goal (\<6.5%) in the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled. For estimating the treatment difference, when the A1C result for a participant at Week 20 was not available, a multiple imputation method was used to impute whether the participant had met the goal."||24.8|0.0|0.049
71077142|NCT01760447|141663946|SUPERIORITY||Kaplan-Meier Difference in Percentage|-13.2||||0.002|TWO_SIDED|95.0|-21.1|-5.3|||Log-Rank Test|||"The percentage of participants initiating glycemic rescue therapy in the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||-5.3|-21.1|0.002
71077143|NCT04575584|141663953|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.562|TWO_SIDED|95.0|0.68|1.45|||Log Rank||Based on Cox regression model with Efron's method of tie handling|||1.45|0.68|0.5620
71077144|NCT04575584|141663953|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.3145|TWO_SIDED|95.0|0.78|1.65|||Log Rank||Based on Cox regression model with Efron's method of tie handling|||1.65|0.78|0.3145
71077145|NCT04575584|141663953|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.4894|TWO_SIDED|95.0|0.69|1.47|||Log Rank||Based on Cox regression model with Efron's method of tie handling|||1.47|0.69|0.4894
71117195|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.25||||0.556|TWO_SIDED|95.0|-0.59|1.1|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.10|-0.59|0.556
71117196|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.44|||<|0.001|TWO_SIDED|95.0|4.17|6.71|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.71|4.17|<0.001
71117197|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.93|||<|0.001|TWO_SIDED|95.0|3.68|6.19|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.19|3.68|<0.001
71117198|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.27|||<|0.001|TWO_SIDED|95.0|4.0|6.54|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.54|4.00|<0.001
71117199|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.06|||<|0.001|TWO_SIDED|95.0|3.79|6.34|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.34|3.79|<0.001
71117200|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.38||||0.392|TWO_SIDED|95.0|-0.49|1.25|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.25|-0.49|0.392
71117201|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.13||||0.762|TWO_SIDED|95.0|-0.98|0.72|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.72|-0.98|0.762
71117202|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.21||||0.638|TWO_SIDED|95.0|-0.66|1.08|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.08|-0.66|0.638
71117203|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.55|||<|0.001|TWO_SIDED|95.0|3.2|5.9|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.90|3.20|<0.001
71117204|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.45|||<|0.001|TWO_SIDED|95.0|3.11|5.78|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.78|3.11|<0.001
70941195|NCT02350127|141382408|SUPERIORITY||Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|1.4||0.03|TWO_SIDED|95.0|0.2|5.6|||Mixed Models Analysis|||restricted to completers||5.6|0.2|0.03
71117205|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.91|||<|0.001|TWO_SIDED|95.0|3.56|6.26|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.26|3.56|<0.001
71117206|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.39|||<|0.001|TWO_SIDED|95.0|3.04|5.74|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.74|3.04|<0.001
71117207|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.16||||0.741|TWO_SIDED|95.0|-0.77|1.08|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.08|-0.77|0.741
70941196|NCT02350127|141382409|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.52||0.68|TWO_SIDED|95.0|-1.23|0.8|||Mixed Models Analysis||Adjusting for baseline participant MOCA scores, robust vce.|||0.80|-1.23|0.68
71117208|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.05||||0.907|TWO_SIDED|95.0|-0.85|0.95|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.95|-0.85|0.907
71117209|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.51||||0.274|TWO_SIDED|95.0|-0.41|1.44|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.44|-0.41|0.274
71117210|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.77|||<|0.001|TWO_SIDED|95.0|2.4|5.13|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.13|2.40|<0.001
71117211|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.91|||<|0.001|TWO_SIDED|95.0|2.56|5.26|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.26|2.56|<0.001
71117212|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.12|||<|0.001|TWO_SIDED|95.0|2.75|5.48|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.48|2.75|<0.001
71117213|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.01|||<|0.001|TWO_SIDED|95.0|2.64|5.38|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.38|2.64|<0.001
71117214|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.25||||0.607|TWO_SIDED|95.0|-1.18|0.69|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.69|-1.18|0.607
71117215|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.1||||0.824|TWO_SIDED|95.0|-1.02|0.81|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.81|-1.02|0.824
71117216|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.1||||0.827|TWO_SIDED|95.0|-0.83|1.04|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.04|-0.83|0.827
71117217|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.98|||<|0.001|TWO_SIDED|95.0|1.58|4.39|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.39|1.58|<0.001
71117218|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.27|||<|0.001|TWO_SIDED|95.0|1.88|4.65|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.65|1.88|<0.001
71117219|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.12|||<|0.001|TWO_SIDED|95.0|1.71|4.52|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.52|1.71|<0.001
71117220|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.57|||<|0.001|TWO_SIDED|95.0|2.16|4.98|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.98|2.16|<0.001
71117221|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.59||||0.232|TWO_SIDED|95.0|-1.55|0.38|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.38|-1.55|0.232
70853837|NCT04345367|141195690|OTHER||Least square mean difference|0.2|||||TWO_SIDED|95.0|-0.1|0.6|||||Quantity of hours slept: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.6|-0.1|
70941197|NCT02350127|141382410|SUPERIORITY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|1.32||0.7|TWO_SIDED|95.0|-3.09|2.08|||Mixed Models Analysis|||adjusting for baseline participant MOCA, robust VCE||2.08|-3.09|0.70
71117222|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.31||||0.522|TWO_SIDED|95.0|-1.24|0.63|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.63|-1.24|0.522
70853838|NCT04345367|141195690|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.2|0.4|||||Quantity of hours slept: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.4|-0.2|
70853839|NCT04345367|141195690|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.2|0.4|||||Quantity of hours slept: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.4|-0.2|
70853840|NCT04345367|141195690|OTHER||Least square mean difference|1.2|||||TWO_SIDED|95.0|-0.9|3.4|||||Short of Breath or Headache score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||3.4|-0.9|
70853841|NCT04345367|141195690|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-2.0|2.2|||||Short of Breath or Headache score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||2.2|-2.0|
70853842|NCT04345367|141195690|OTHER||Least square mean difference|0.6|||||TWO_SIDED|95.0|-1.5|2.6|||||Short of Breath or Headache score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||2.6|-1.5|
70941198|NCT02350127|141382411|SUPERIORITY||Mean Difference (Final Values)|5.1|STANDARD_ERROR_OF_MEAN|2.2||0.02|TWO_SIDED|95.0|0.8|9.4|||Mixed Models Analysis|||||9.4|0.8|0.02
71077146|NCT04575584|141663956|SUPERIORITY||Mean Difference (Final Values)|4.1||||0.1642|TWO_SIDED|95.0|-2.3|12.1|||Miettinen and Nurminen method||Miettinen and Nurminen method. Unknown Day 29 survival status treated as failure.|||12.1|-2.3|0.1642
71077147|NCT04575584|141663956|SUPERIORITY||Mean Difference (Final Values)|5.5||||0.09|TWO_SIDED|95.0|-1.1|13.9|||Miettinen and Nurminen method||Miettinen and Nurminen method. Unknown Day 29 survival status treated as failure.|||13.9|-1.1|0.0900
71077148|NCT04575584|141663956|SUPERIORITY||Mean Difference (Final Values)|4.2||||0.1594|TWO_SIDED|95.0|-2.3|12.3|||Miettinen and Nurminen method||Miettinen and Nurminen method. Unknown Day 29 survival status treated as failure.|||12.3|-2.3|0.1594
71077149|NCT04575584|141663957|SUPERIORITY||Odds Ratio (OR)|1.31||||0.3623|TWO_SIDED|95.0|0.73|2.35|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. Confidence intervals (CIs) are based on Wald Chi-Square Test.|||2.35|0.73|0.3623
70853843|NCT04345367|141195690|OTHER||Least square mean difference|-1.8|||||TWO_SIDED|95.0|-4.2|0.5|||||Snoring score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.5|-4.2|
70853844|NCT04345367|141195690|OTHER||Least square mean difference|-0.9|||||TWO_SIDED|95.0|-3.3|1.5|||||Snoring score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||1.5|-3.3|
70853845|NCT04345367|141195690|OTHER||Least square mean difference|0.8|||||TWO_SIDED|95.0|-1.7|3.4|||||Snoring score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||3.4|-1.7|
70853846|NCT04345367|141195690|OTHER||Least square mean difference|-4.1|||||TWO_SIDED|95.0|-6.6|-1.6|||||Sleep disturbance score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-1.6|-6.6|
70853847|NCT04345367|141195690|OTHER||Least square mean difference|-3.8|||||TWO_SIDED|95.0|-6.2|-1.4|||||Sleep disturbance score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-1.4|-6.2|
70853848|NCT04345367|141195690|OTHER||Least square mean difference|-1.7|||||TWO_SIDED|95.0|-4.1|0.7|||||Sleep disturbance score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.7|-4.1|
70853849|NCT04345367|141195690|OTHER||Least square mean difference|1.0|||||TWO_SIDED|95.0|-1.6|3.6|||||Sleep adequacy score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||3.6|-1.6|
70853850|NCT04345367|141195690|OTHER||Least square mean difference|2.9|||||TWO_SIDED|95.0|0.4|5.4|||||Sleep adequacy score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||5.4|0.4|
70853851|NCT04345367|141195690|OTHER||Least square mean difference|0.7|||||TWO_SIDED|95.0|-1.9|3.4|||||Sleep adequacy score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||3.4|-1.9|
70941199|NCT02350127|141382412|SUPERIORITY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|4.3||0.47|TWO_SIDED|95.0|-5.4|11.6|||Mixed Models Analysis|||||11.6|-5.4|0.47
70941200|NCT02350127|141382413|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.54||0.99|TWO_SIDED|95.0|-1.1|1.1|||Mixed Models Analysis|||||1.1|-1.1|0.99
71077150|NCT04575584|141663957|SUPERIORITY||Odds Ratio (OR)|1.18||||0.5714|TWO_SIDED|95.0|0.66|2.12|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.12|0.66|0.5714
71077151|NCT04575584|141663957|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9313|TWO_SIDED|95.0|0.54|1.75|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.75|0.54|0.9313
71077152|NCT04575584|141663958|SUPERIORITY||Odds Ratio (OR)|1.27||||0.4398|TWO_SIDED|95.0|0.7|2.3|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.30|0.70|0.4398
70853852|NCT04345367|141195690|OTHER||Least square mean difference|-0.8|||||TWO_SIDED|95.0|-2.8|1.3|||||Sleep somnolence score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||1.3|-2.8|
71117223|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.45||||0.356|TWO_SIDED|95.0|-1.41|0.51|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.51|-1.41|0.356
71117224|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.31||||0.001|TWO_SIDED|95.0|0.92|3.69|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.69|0.92|0.001
71117225|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.45|||<|0.001|TWO_SIDED|95.0|1.08|3.82|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.82|1.08|<0.001
71117226|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.7|||<|0.001|TWO_SIDED|95.0|1.31|4.08|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.08|1.31|<0.001
71117227|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.85|||<|0.001|TWO_SIDED|95.0|1.46|4.23|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.23|1.46|<0.001
71117228|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.54||||0.264|TWO_SIDED|95.0|-1.49|0.41|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.41|-1.49|0.264
71117229|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.4||||0.4|TWO_SIDED|95.0|-1.32|0.53|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.53|-1.32|0.400
71117230|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.15||||0.758|TWO_SIDED|95.0|-1.1|0.8|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.80|-1.10|0.758
71117231|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.62||||0.018|TWO_SIDED|95.0|0.27|2.97|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.97|0.27|0.018
71117232|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.88||||0.006|TWO_SIDED|95.0|0.55|3.21|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.21|0.55|0.006
71117233|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.29|||<|0.001|TWO_SIDED|95.0|0.94|3.63|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.63|0.94|<0.001
71117234|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.4|||<|0.001|TWO_SIDED|95.0|1.05|3.75|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.75|1.05|<0.001
71117235|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.78||||0.097|TWO_SIDED|95.0|-1.7|0.14|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.14|-1.70|0.097
71117236|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.52||||0.254|TWO_SIDED|95.0|-1.42|0.38|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.38|-1.42|0.254
71117237|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.11||||0.812|TWO_SIDED|95.0|-1.03|0.81|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.81|-1.03|0.812
71117238|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.32||||0.045|TWO_SIDED|95.0|0.03|2.61|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.61|0.03|0.045
71117239|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.59||||0.015|TWO_SIDED|95.0|0.31|2.87|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.87|0.31|0.015
71117240|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.73||||0.009|TWO_SIDED|95.0|0.43|3.02|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.02|0.43|0.009
70853853|NCT04345367|141195690|OTHER||Least square mean difference|-2.4|||||TWO_SIDED|95.0|-4.4|-0.4|||||Sleep somnolence score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.4|-4.4|
70941201|NCT02350127|141382414|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|3.7||0.98|TWO_SIDED|95.0|-7.4|7.2|||Mixed Models Analysis|||||7.2|-7.4|0.98
71117241|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.08||||0.002|TWO_SIDED|95.0|0.78|3.37|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.37|0.78|0.002
71117242|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.76||||0.094|TWO_SIDED|95.0|-1.64|0.13|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.13|-1.64|0.094
71117243|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.49||||0.269|TWO_SIDED|95.0|-1.35|0.38|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.38|-1.35|0.269
71117244|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.35||||0.437|TWO_SIDED|95.0|-1.23|0.53|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.53|-1.23|0.437
71117245|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.74||||0.218|TWO_SIDED|95.0|-0.44|1.92|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.92|-0.44|0.218
71117246|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.19||||0.046|TWO_SIDED|95.0|0.02|2.35|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.35|0.02|0.046
71117247|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.31||||0.03|TWO_SIDED|95.0|0.13|2.49|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.49|0.13|0.030
71117248|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.75||||0.004|TWO_SIDED|95.0|0.57|2.93|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.93|0.57|0.004
71117249|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.01||||0.014|TWO_SIDED|95.0|-1.82|-0.2|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||-0.20|-1.82|0.014
71117250|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.56||||0.16|TWO_SIDED|95.0|-1.35|0.22|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.22|-1.35|0.160
71117251|NCT01559259|141740581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.44||||0.284|TWO_SIDED|95.0|-1.25|0.37|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.37|-1.25|0.284
71117252|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.62||||0.014|TWO_SIDED|95.0|0.13|1.1|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.10|0.13|0.014
71117253|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.46||||0.066|TWO_SIDED|95.0|-0.03|0.94|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.94|-0.03|0.066
71117254|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.71||||0.004|TWO_SIDED|95.0|0.22|1.2|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.20|0.22|0.004
71117255|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.3||||0.232|TWO_SIDED|95.0|-0.19|0.78|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.78|-0.19|0.232
71117256|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.32||||0.067|TWO_SIDED|95.0|-0.02|0.66|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.66|-0.02|0.067
71117257|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.16||||0.354|TWO_SIDED|95.0|-0.18|0.5|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.50|-0.18|0.354
71117258|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.42||||0.017|TWO_SIDED|95.0|0.08|0.76|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.76|0.08|0.017
71117259|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.15|||<|0.001|TWO_SIDED|95.0|1.45|2.86|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.86|1.45|<0.001
70941202|NCT02350127|141382415|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|1.5||0.8|TWO_SIDED|95.0|-2.5|3.3|||Mixed Models Analysis|||||3.3|-2.5|0.80
71117260|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.93|||<|0.001|TWO_SIDED|95.0|1.23|2.64|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.64|1.23|<0.001
70941203|NCT02350127|141382416|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|1.1||0.38|TWO_SIDED|95.0|-3.1|1.2|||Mixed Models Analysis|||||1.2|-3.1|0.38
70853854|NCT04345367|141195690|OTHER||Least square mean difference|-2.3|||||TWO_SIDED|95.0|-4.3|-0.3|||||Sleep somnolence score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.3|-4.3|
70853855|NCT04345367|141195690|OTHER||Least square mean difference|-1.2|||||TWO_SIDED|95.0|-3.0|0.7|||||Sleep Problems Index I score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.7|-3.0|
70941204|NCT02350127|141382417|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.45||0.075|TWO_SIDED|95.0|-1.7|0.1|||Mixed Models Analysis|||||0.1|-1.7|0.075
70853856|NCT04345367|141195690|OTHER||Least square mean difference|-2.3|||||TWO_SIDED|95.0|-4.0|-0.5|||||Sleep Problems Index I score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.5|-4.0|
70853857|NCT04345367|141195690|OTHER||Least square mean difference|-0.8|||||TWO_SIDED|95.0|-2.5|0.9|||||Sleep Problems Index I score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.9|-2.5|
70853858|NCT04345367|141195690|OTHER||Least square mean difference|-2.2|||||TWO_SIDED|95.0|-4.0|-0.3|||||Sleep Problems Index II score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.3|-4.0|
70941205|NCT02350127|141382418|SUPERIORITY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|1.7||0.35|TWO_SIDED|95.0|-1.7|5.0|||Mixed Models Analysis|||||5.0|-1.7|0.35
70941206|NCT02350127|141382419|SUPERIORITY||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|2.1||0.35|TWO_SIDED|95.0|-6.1|2.1|||Mixed Models Analysis|||||2.1|-6.1|0.35
71117261|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.09|||<|0.001|TWO_SIDED|95.0|1.39|2.8|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.80|1.39|<0.001
71117262|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.32|||<|0.001|TWO_SIDED|95.0|0.61|2.02|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.02|0.61|<0.001
71117263|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.83|||<|0.001|TWO_SIDED|95.0|0.34|1.33|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.33|0.34|<0.001
71117264|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.62||||0.014|TWO_SIDED|95.0|0.12|1.11|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.11|0.12|0.014
71117265|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.77||||0.002|TWO_SIDED|95.0|0.28|1.27|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.27|0.28|0.002
71117266|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.45|||<|0.001|TWO_SIDED|95.0|2.69|4.22|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.22|2.69|<0.001
71117267|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.13|||<|0.001|TWO_SIDED|95.0|2.36|3.89|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.89|2.36|<0.001
71117268|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.49|||<|0.001|TWO_SIDED|95.0|2.72|4.26|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.26|2.72|<0.001
71117269|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.78|||<|0.001|TWO_SIDED|95.0|2.02|3.54|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.54|2.02|<0.001
71117270|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.67||||0.014|TWO_SIDED|95.0|0.14|1.21|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.21|0.14|0.014
71117271|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.35||||0.202|TWO_SIDED|95.0|-0.19|0.88|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.88|-0.19|0.202
71117272|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.71||||0.01|TWO_SIDED|95.0|0.17|1.24|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.24|0.17|0.010
71117273|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.0|||<|0.001|TWO_SIDED|95.0|3.24|4.76|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.76|3.24|<0.001
71117274|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.55|||<|0.001|TWO_SIDED|95.0|2.79|4.31|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.31|2.79|<0.001
71117275|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.03|||<|0.001|TWO_SIDED|95.0|3.27|4.79|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.79|3.27|<0.001
71117276|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.48|||<|0.001|TWO_SIDED|95.0|2.72|4.24|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.24|2.72|<0.001
71117277|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.52||||0.056|TWO_SIDED|95.0|-0.01|1.05|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.05|-0.01|0.056
71117278|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.07||||0.789|TWO_SIDED|95.0|-0.46|0.6|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.60|-0.46|0.789
71117279|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.55||||0.042|TWO_SIDED|95.0|0.02|1.08|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.08|0.02|0.042
71117280|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.17|||<|0.001|TWO_SIDED|95.0|3.37|4.98|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.98|3.37|<0.001
70853859|NCT04345367|141195690|OTHER||Least square mean difference|-2.9|||||TWO_SIDED|95.0|-4.8|-1.1|||||Sleep Problems Index II score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-1.1|-4.8|
70853860|NCT04345367|141195690|OTHER||Least square mean difference|-1.4|||||TWO_SIDED|95.0|-3.2|0.4|||||Sleep Problems Index II score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.4|-3.2|
70853861|NCT04345367|141195691|OTHER||Least square mean difference|-1.1|||||TWO_SIDED|95.0|-1.5|-0.8|||||Week 2. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.8|-1.5|
71117281|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.86|||<|0.001|TWO_SIDED|95.0|3.06|4.66|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.66|3.06|<0.001
71117282|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.34|||<|0.001|TWO_SIDED|95.0|3.54|5.14|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.14|3.54|<0.001
71117283|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.89|||<|0.001|TWO_SIDED|95.0|3.09|4.69|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.69|3.09|<0.001
71117284|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.29||||0.317|TWO_SIDED|95.0|-0.28|0.85|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.85|-0.28|0.317
71117285|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.03||||0.922|TWO_SIDED|95.0|-0.59|0.53|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.53|-0.59|0.922
71117286|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.45||||0.112|TWO_SIDED|95.0|-0.11|1.02|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.02|-0.11|0.112
71117287|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.1|||<|0.001|TWO_SIDED|95.0|3.27|4.94|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.94|3.27|<0.001
71117288|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.76|||<|0.001|TWO_SIDED|95.0|2.92|4.59|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.59|2.92|<0.001
71117289|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.15|||<|0.001|TWO_SIDED|95.0|3.32|4.99|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.99|3.32|<0.001
71117290|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.89|||<|0.001|TWO_SIDED|95.0|3.05|4.72|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.72|3.05|<0.001
70853862|NCT04345367|141195691|OTHER||Least square mean difference|-0.4|||||TWO_SIDED|95.0|-0.8|-0.1|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.1|-0.8|
70853863|NCT04345367|141195691|OTHER||Least square mean difference|-0.2|||||TWO_SIDED|95.0|-0.6|0.1|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.1|-0.6|
70853864|NCT04345367|141195691|OTHER||Least square mean difference|-0.3|||||TWO_SIDED|95.0|-0.6|0.0|||||Week 20. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.0|-0.6|
70853865|NCT04345367|141195691|OTHER||Least square mean difference|-0.2|||||TWO_SIDED|95.0|-0.5|0.1|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.1|-0.5|
70853866|NCT04345367|141195692|OTHER||Least square mean difference|18.1|||||TWO_SIDED|95.0|10.5|25.7||||||Analysis was performed using analysis of covariance (ANCOVA) model including treatment as a main effect and baseline disease severity as covariates.||25.7|10.5|
71117291|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.22||||0.464|TWO_SIDED|95.0|-0.37|0.81|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.81|-0.37|0.464
71117292|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.13||||0.667|TWO_SIDED|95.0|-0.71|0.45|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.45|-0.71|0.667
71117293|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.27||||0.368|TWO_SIDED|95.0|-0.32|0.86|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.86|-0.32|0.368
71117294|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.94|||<|0.001|TWO_SIDED|95.0|3.08|4.81|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.81|3.08|<0.001
71117295|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.63|||<|0.001|TWO_SIDED|95.0|2.77|4.49|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.49|2.77|<0.001
70853867|NCT04345367|141195693|OTHER||Estimate of difference|13.7|||||TWO_SIDED|95.0|7.3|20.1|||||Week 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||20.1|7.3|
71077153|NCT04575584|141663958|SUPERIORITY||Odds Ratio (OR)|0.86||||0.6277|TWO_SIDED|95.0|0.47|1.57|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.57|0.47|0.6277
71117296|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.06|||<|0.001|TWO_SIDED|95.0|3.19|4.92|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.92|3.19|<0.001
71117297|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.68|||<|0.001|TWO_SIDED|95.0|2.82|4.54|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.54|2.82|<0.001
71117298|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.26||||0.397|TWO_SIDED|95.0|-0.34|0.86|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.86|-0.34|0.397
71117299|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.866|TWO_SIDED|95.0|-0.65|0.55|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.55|-0.65|0.866
71117300|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.37||||0.226|TWO_SIDED|95.0|-0.23|0.97|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.97|-0.23|0.226
70941207|NCT02350127|141382420|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.54|TWO_SIDED|95.0|-0.4|0.8|||Mixed Models Analysis|||||0.8|-0.4|0.54
71077154|NCT04575584|141663958|SUPERIORITY||Odds Ratio (OR)|0.89||||0.7069|TWO_SIDED|95.0|0.49|1.62|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.62|0.49|0.7069
71077155|NCT04575584|141663959|SUPERIORITY||Odds Ratio (OR)|1.48||||0.2422|TWO_SIDED|95.0|0.77|2.85|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.85|0.77|0.2422
71077156|NCT04575584|141663959|SUPERIORITY||Odds Ratio (OR)|1.27||||0.4789|TWO_SIDED|95.0|0.66|2.44|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.44|0.66|0.4789
71077157|NCT04575584|141663959|SUPERIORITY||Odds Ratio (OR)|0.85||||0.6052|TWO_SIDED|95.0|0.45|1.59|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.59|0.45|0.6052
71077158|NCT04575584|141663960|SUPERIORITY||Odds Ratio (OR)|1.47||||0.2644|TWO_SIDED|95.0|0.75|2.88|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.88|0.75|0.2644
71077159|NCT04575584|141663960|SUPERIORITY||Odds Ratio (OR)|1.55||||0.2184|TWO_SIDED|95.0|0.77|3.14|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||3.14|0.77|0.2184
70941208|NCT02350127|141382421|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.9||0.69|TWO_SIDED|95.0|-1.5|2.2|||Mixed Models Analysis|||||2.2|-1.5|0.69
70941209|NCT02350127|141382422|SUPERIORITY||Median Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|5.2||0.88|TWO_SIDED|95.0|-10.9|9.3|||Mixed Models Analysis|||||9.3|-10.9|0.88
71077160|NCT04575584|141663960|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9771|TWO_SIDED|95.0|0.53|1.94|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.94|0.53|0.9771
71077161|NCT04575584|141663961|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9945|TWO_SIDED|95.0|0.46|2.06|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.06|0.46|0.9945
71077162|NCT04575584|141663961|SUPERIORITY||Odds Ratio (OR)|1.5||||0.3227|TWO_SIDED|95.0|0.67|3.37|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||3.37|0.67|0.3227
71077163|NCT04575584|141663961|SUPERIORITY||Odds Ratio (OR)|0.79||||0.52|TWO_SIDED|95.0|0.39|1.61|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.61|0.39|0.5200
71117301|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.8|||<|0.001|TWO_SIDED|95.0|2.9|4.7|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.70|2.90|<0.001
71117302|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.37|||<|0.001|TWO_SIDED|95.0|2.47|4.26|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.26|2.47|<0.001
71117303|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.89|||<|0.001|TWO_SIDED|95.0|2.99|4.79|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.79|2.99|<0.001
71117304|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.6|||<|0.001|TWO_SIDED|95.0|2.7|4.5|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.50|2.70|<0.001
71117305|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.2||||0.536|TWO_SIDED|95.0|-0.43|0.83|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.83|-0.43|0.536
71117306|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.23||||0.467|TWO_SIDED|95.0|-0.86|0.39|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.39|-0.86|0.467
71117307|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.29||||0.361|TWO_SIDED|95.0|-0.34|0.92|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.92|-0.34|0.361
71117308|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.17|||<|0.001|TWO_SIDED|95.0|2.21|4.13|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.13|2.21|<0.001
71117309|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.99|||<|0.001|TWO_SIDED|95.0|2.04|3.95|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.95|2.04|<0.001
71117310|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.51|||<|0.001|TWO_SIDED|95.0|2.55|4.47|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.47|2.55|<0.001
71117311|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.04|||<|0.001|TWO_SIDED|95.0|2.09|4.0|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.00|2.09|<0.001
71117312|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.13||||0.704|TWO_SIDED|95.0|-0.54|0.8|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.80|-0.54|0.704
71117313|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.89|TWO_SIDED|95.0|-0.71|0.62|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.62|-0.71|0.890
71117314|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.47||||0.17|TWO_SIDED|95.0|-0.2|1.14|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.14|-0.20|0.170
71117315|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.69|||<|0.001|TWO_SIDED|95.0|1.72|3.67|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.67|1.72|<0.001
71117316|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.58|||<|0.001|TWO_SIDED|95.0|1.61|3.56|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.56|1.61|<0.001
71117317|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.99|||<|0.001|TWO_SIDED|95.0|2.01|3.97|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.97|2.01|<0.001
70853868|NCT04345367|141195693|OTHER||Estimate of difference|3.9|||||TWO_SIDED|95.0|-1.6|9.4|||||Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||9.4|-1.6|
70941210|NCT02350127|141382423|SUPERIORITY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.8||0.26|TWO_SIDED|95.0|-0.7|2.5|||Mixed Models Analysis|||||2.5|-0.7|0.26
70941211|NCT02350127|141382424|SUPERIORITY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|1.1||0.08|TWO_SIDED|95.0|-3.9|0.2|||Mixed Models Analysis|||||0.2|-3.9|0.08
71117318|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.75|||<|0.001|TWO_SIDED|95.0|1.77|3.72|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.72|1.77|<0.001
71117319|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.882|TWO_SIDED|95.0|-0.74|0.63|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.63|-0.74|0.882
71117320|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.16||||0.64|TWO_SIDED|95.0|-0.84|0.52|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.52|-0.84|0.640
71077164|NCT04575584|141663962|SUPERIORITY||Odds Ratio (OR)|1.25||||0.4472|TWO_SIDED|95.0|0.7|2.25|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.25|0.70|0.4472
71077165|NCT04575584|141663962|SUPERIORITY||Odds Ratio (OR)|1.18||||0.5714|TWO_SIDED|95.0|0.66|2.12|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.12|0.66|0.5714
71077166|NCT04575584|141663962|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9313|TWO_SIDED|95.0|0.54|1.75|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.75|0.54|0.9313
71077167|NCT04575584|141663963|SUPERIORITY||Odds Ratio (OR)|1.22||||0.5222|TWO_SIDED|95.0|0.67|2.21|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.21|0.67|0.5222
70941212|NCT03906240|141382431|SUPERIORITY||Cohen's d|1.44|||<|0.001|TWO_SIDED|95.0|1.0|2.49|||t-test, 2 sided|t = 5.78||Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||2.49|1.00|<.001
70941213|NCT03906240|141382431|SUPERIORITY||Cohen's d|0.78||||0.002|TWO_SIDED|95.0|0.35|1.38|||t-test, 2 sided|t = 3.48||Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||1.38|0.35|.002
70941214|NCT03906240|141382432|SUPERIORITY||Cohen's d|0.01||||0.957|TWO_SIDED|95.0|-0.45|0.91|||t-test, 2 sided|t = 0.06||Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||0.91|-0.45|.957
71077168|NCT04575584|141663963|SUPERIORITY||Odds Ratio (OR)|0.86||||0.6277|TWO_SIDED|95.0|0.47|1.57|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.57|0.47|0.6277
70941215|NCT03906240|141382432|SUPERIORITY||Cohen's d|0.51||||0.033|TWO_SIDED|95.0|0.08|1.25|||t-test, 2 sided|t = 2.30||Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||1.25|0.08|.033
71117321|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.24||||0.482|TWO_SIDED|95.0|-0.44|0.93|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.93|-0.44|0.482
71117322|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.06|||<|0.001|TWO_SIDED|95.0|1.07|3.06|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.06|1.07|<0.001
71117323|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.17|||<|0.001|TWO_SIDED|95.0|1.17|3.16|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.16|1.17|<0.001
71117324|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.24|||<|0.001|TWO_SIDED|95.0|1.25|3.24|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.24|1.25|<0.001
71117325|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.42|||<|0.001|TWO_SIDED|95.0|1.43|3.41|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.41|1.43|<0.001
71117326|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.36||||0.314|TWO_SIDED|95.0|-1.05|0.34|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.34|-1.05|0.314
71117327|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.25||||0.469|TWO_SIDED|95.0|-0.95|0.44|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.44|-0.95|0.469
71117328|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.18||||0.616|TWO_SIDED|95.0|-0.87|0.52|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.52|-0.87|0.616
71117329|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.57||||0.002|TWO_SIDED|95.0|0.57|2.56|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.56|0.57|0.002
71117330|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.54||||0.002|TWO_SIDED|95.0|0.55|2.53|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.53|0.55|0.002
71117331|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.95|||<|0.001|TWO_SIDED|95.0|0.95|2.94|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.94|0.95|<0.001
71117332|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.91|||<|0.001|TWO_SIDED|95.0|0.92|2.9|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.90|0.92|<0.001
71117333|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.34||||0.33|TWO_SIDED|95.0|-1.04|0.35|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.35|-1.04|0.330
71117334|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.37||||0.288|TWO_SIDED|95.0|-1.06|0.32|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.32|-1.06|0.288
71117335|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.04||||0.916|TWO_SIDED|95.0|-0.66|0.73|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.73|-0.66|0.916
71117336|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.01||||0.041|TWO_SIDED|95.0|0.04|1.98|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.98|0.04|0.041
71117337|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.05||||0.034|TWO_SIDED|95.0|0.08|2.01|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.01|0.08|0.034
71117338|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.59||||0.001|TWO_SIDED|95.0|0.62|2.56|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.56|0.62|0.001
71117339|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.48||||0.003|TWO_SIDED|95.0|0.52|2.45|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.45|0.52|0.003
71117340|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.47||||0.171|TWO_SIDED|95.0|-1.15|0.2|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.20|-1.15|0.171
71117341|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.44||||0.201|TWO_SIDED|95.0|-1.11|0.23|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.23|-1.11|0.201
71117342|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.1||||0.763|TWO_SIDED|95.0|-0.57|0.78|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.78|-0.57|0.763
71117343|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.66||||0.175|TWO_SIDED|95.0|-0.3|1.61|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.61|-0.30|0.175
71117344|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.75||||0.12|TWO_SIDED|95.0|-0.2|1.7|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.70|-0.20|0.120
71117345|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.19||||0.014|TWO_SIDED|95.0|0.24|2.15|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.15|0.24|0.014
71117346|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.31||||0.007|TWO_SIDED|95.0|0.36|2.26|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.26|0.36|0.007
71117347|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.66||||0.054|TWO_SIDED|95.0|-1.32|0.01|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.01|-1.32|0.054
71117348|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.56||||0.096|TWO_SIDED|95.0|-1.22|0.1|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.10|-1.22|0.096
71117349|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.12||||0.724|TWO_SIDED|95.0|-0.79|0.55|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.55|-0.79|0.724
71117350|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.42||||0.345|TWO_SIDED|95.0|-0.46|1.3|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.30|-0.46|0.345
71117351|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.54||||0.228|TWO_SIDED|95.0|-0.34|1.41|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.41|-0.34|0.228
70941216|NCT03906240|141382433|SUPERIORITY||Cohen's d|0.71||||0.015|TWO_SIDED|95.0|0.32|1.31|||t-test, 2 sided|t = 2.76||Physical Domain: Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||1.31|0.32|.015
70941217|NCT03906240|141382433|SUPERIORITY||Cohen's d|0.74||||0.012|TWO_SIDED|95.0|0.26|1.55|||t-test, 2 sided|t = 2.87||Psychological Domain: Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||1.55|0.26|.012
71117352|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.9||||0.045|TWO_SIDED|95.0|0.02|1.78|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.78|0.02|0.045
71077169|NCT04575584|141663963|SUPERIORITY||Odds Ratio (OR)|0.89||||0.7069|TWO_SIDED|95.0|0.49|1.62|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.62|0.49|0.7069
71077170|NCT04575584|141663964|SUPERIORITY||Odds Ratio (OR)|1.46||||0.2627|TWO_SIDED|95.0|0.75|2.8|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.80|0.75|0.2627
71117353|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.08||||0.016|TWO_SIDED|95.0|0.21|1.96|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.96|0.21|0.016
71117354|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.66||||0.036|TWO_SIDED|95.0|-1.27|-0.04|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||-0.04|-1.27|0.036
71117355|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.54||||0.081|TWO_SIDED|95.0|-1.15|0.07|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.07|-1.15|0.081
71117356|NCT01559259|141740582|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.18||||0.556|TWO_SIDED|95.0|-0.8|0.43|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.43|-0.80|0.556
71117357|NCT01559259|141740583|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.53|||<|0.001|TWO_SIDED|95.0|2.01|3.05||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.05|2.01|<0.001
71077171|NCT04575584|141663964|SUPERIORITY||Odds Ratio (OR)|1.27||||0.4789|TWO_SIDED|95.0|0.66|2.44|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.44|0.66|0.4789
71077172|NCT04575584|141663964|SUPERIORITY||Odds Ratio (OR)|0.84||||0.5938|TWO_SIDED|95.0|0.45|1.58|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.58|0.45|0.5938
71077173|NCT04575584|141663965|SUPERIORITY||Odds Ratio (OR)|1.47||||0.2644|TWO_SIDED|95.0|0.75|2.88|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.88|0.75|0.2644
71117358|NCT01559259|141740583|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.23|||<|0.001|TWO_SIDED|95.0|1.72|2.75||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.75|1.72|<0.001
71077174|NCT04575584|141663965|SUPERIORITY||Odds Ratio (OR)|1.55||||0.2184|TWO_SIDED|95.0|0.77|3.14|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||3.14|0.77|0.2184
71077175|NCT04575584|141663965|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9771|TWO_SIDED|95.0|0.53|1.94|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.94|0.53|0.9771
71077176|NCT04575584|141663966|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9445|TWO_SIDED|95.0|0.46|2.06|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.06|0.46|0.9445
71077177|NCT04575584|141663966|SUPERIORITY||Odds Ratio (OR)|1.5||||0.3227|TWO_SIDED|95.0|0.67|3.37|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||3.37|0.67|0.3227
71077178|NCT04575584|141663966|SUPERIORITY||Odds Ratio (OR)|0.79||||0.52|TWO_SIDED|95.0|0.39|1.61|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.61|0.39|0.5200
71077179|NCT04575584|141663967|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8732|TWO_SIDED|95.0|0.46|2.47|||Wald Chi-Square||Proportional odds model with National Early Warning Score (NEWS) categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.47|0.46|0.8732
71077180|NCT04575584|141663967|SUPERIORITY||Odds Ratio (OR)|0.54||||0.1277|TWO_SIDED|95.0|0.25|1.19|||Wald Chi-square||Proportional odds model with NEWS categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.19|0.25|0.1277
71117359|NCT01559259|141740583|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.56|||<|0.001|TWO_SIDED|95.0|2.04|3.08||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.08|2.04|<0.001
71077181|NCT04575584|141663967|SUPERIORITY||Odds Ratio (OR)|0.73||||0.4326|TWO_SIDED|95.0|0.33|1.61|||Wald Chi-Square||Proportional odds model with NEWS categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.61|0.33|0.4326
71077182|NCT04575584|141663968|SUPERIORITY||Odds Ratio (OR)|1.2||||0.683|TWO_SIDED|95.0|0.5|2.88|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.88|0.50|0.6830
71077183|NCT04575584|141663968|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.42|2.39|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.39|0.42|1.000
71077184|NCT04575584|141663968|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8244|TWO_SIDED|95.0|0.37|2.2|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.20|0.37|0.8244
71077185|NCT04575584|141663969|SUPERIORITY||Odds Ratio (OR)|0.77||||0.5022|TWO_SIDED|95.0|0.36|1.64|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.64|0.36|0.5022
70853869|NCT04345367|141195693|OTHER||Estimate of difference|-1.6|||||TWO_SIDED|95.0|-7.1|4.0|||||Week 16. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||4.0|-7.1|
71077186|NCT04575584|141663969|SUPERIORITY||Odds Ratio (OR)|0.78||||0.5204|TWO_SIDED|95.0|0.37|1.64|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.64|0.37|0.5204
71077187|NCT04575584|141663969|SUPERIORITY||Odds Ratio (OR)|0.52||||0.0991|TWO_SIDED|95.0|0.24|1.13|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.13|0.24|0.0991
70853870|NCT04345367|141195693|OTHER||Estimate of difference|-2.0|||||TWO_SIDED|95.0|-7.6|3.6|||||Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||3.6|-7.6|
70853871|NCT04345367|141195693|OTHER||Estimate of difference|-4.2|||||TWO_SIDED|95.0|-10.3|1.9|||||Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||1.9|-10.3|
70941218|NCT03906240|141382433|SUPERIORITY||Cohen's d|0.02||||0.941|TWO_SIDED|95.0|-0.43|0.55|||t-test, 2 sided|t = 0.08||Physical Domain: Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||0.55|-0.43|.941
71077188|NCT04575584|141663970|SUPERIORITY||Odds Ratio (OR)|1.18||||0.6346|TWO_SIDED|95.0|0.6|2.29|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.29|0.60|0.6346
71077189|NCT04575584|141663970|SUPERIORITY||Odds Ratio (OR)|0.9||||0.7596|TWO_SIDED|95.0|0.46|1.75|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.75|0.46|0.7596
71077190|NCT04575584|141663970|SUPERIORITY||Odds Ratio (OR)|0.95||||0.8879|TWO_SIDED|95.0|0.49|1.84|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.84|0.49|0.8879
71077191|NCT04575584|141663971|SUPERIORITY||Odds Ratio (OR)|1.24||||0.6002|TWO_SIDED|95.0|0.55|2.82|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.82|0.55|0.6002
71077192|NCT04575584|141663971|SUPERIORITY||Odds Ratio (OR)|1.37||||0.4733|TWO_SIDED|95.0|0.58|3.21|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||3.21|0.58|0.4733
71077193|NCT04575584|141663971|SUPERIORITY||Odds Ratio (OR)|0.82||||0.622|TWO_SIDED|95.0|0.38|1.78|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.78|0.38|0.6220
71077194|NCT04575584|141663972|SUPERIORITY||Odds Ratio (OR)|0.86||||0.7871|TWO_SIDED|95.0|0.28|2.6|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.60|0.28|0.7871
71077195|NCT04575584|141663972|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9598|TWO_SIDED|95.0|0.31|3.06|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||3.06|0.31|0.9598
71077196|NCT04575584|141663972|SUPERIORITY||Odds Ratio (OR)|0.79||||0.667|TWO_SIDED|95.0|0.27|2.31|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.31|0.27|0.6670
71077197|NCT02815267|141663984|SUPERIORITY||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|1.06||0.0083|TWO_SIDED|95.0|0.72|4.88|||ANCOVA|||Change from baseline in inflammatory lesion count was analyzed using an analysis of covariance (ANCOVA) model, which included treatment, Baseline inflammatory lesion count and pooled investigational site as a blocking factor.||4.88|0.72|0.0083
71077198|NCT02815267|141663985|SUPERIORITY||Risk Difference (RD)|3.33|STANDARD_ERROR_OF_MEAN|2.48||0.1805|TWO_SIDED|95.0|-1.54|8.19||P-value is for the null hypothesis that the combined risk difference equals 0.|Cochran-Mantel-Haenszel|||||8.19|-1.54|0.1805
71077199|NCT02815267|141663986|SUPERIORITY|Percent change from baseline was analyzed using an ANCOVA model, which included treatment, baseline non-inflammatory lesion counts and pooled investigational site as a blocking factor. For the superiority comparison between FMX101 4% and vehicle.|Mean Difference (Final Values)|12.73|STANDARD_ERROR_OF_MEAN|4.42||0.004|TWO_SIDED|95.0|4.07|21.39|||ANCOVA|||||21.39|4.07|0.0040
71077200|NCT02815267|141663987|SUPERIORITY|Change from baseline in inflammatory lesion count for Week 6 was analyzed using an ANCOVA model, which included treatment, baseline inflammatory lesion counts and pooled investigational site as a blocking factor.|Mean Difference (Final Values)|3.86|STANDARD_ERROR_OF_MEAN|1.03||0.0002|TWO_SIDED|95.0|1.85|5.87|||ANCOVA|||||5.87|1.85|0.0002
71077201|NCT02815267|141663987|SUPERIORITY|Change from baseline in inflammatory lesion count for Week 9 was analyzed using an ANCOVA model, which included treatment, baseline inflammatory lesion counts and pooled investigational site as a blocking factor.|Mean Difference (Final Values)|4.39|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|95.0|2.38|6.4|||ANCOVA|||||6.40|2.38|<.0001
71077202|NCT02815267|141663988|SUPERIORITY|P-value is for null hypothesis that the combined risk difference equals 0. Percentage of participants achieving IGA treatment success at Week 6|Risk Difference (RD)|2.71|STANDARD_ERROR_OF_MEAN|1.32||0.0395|TWO_SIDED|95.0|0.13|5.3|||Cochran-Mantel-Haenszel|||||5.3|0.13|0.0395
71077203|NCT02815267|141663988|SUPERIORITY|P-value is for null hypothesis that the combined risk difference equals 0. Percentage of participants achieving IGA treatment success at Week 9.|Risk Difference (RD)|2.76|STANDARD_ERROR_OF_MEAN|1.55||0.0748|TWO_SIDED|95.0|-0.28|5.8|||Cochran-Mantel-Haenszel|||||5.80|-0.28|0.0748
71077204|NCT04278924|141664020|SUPERIORITY||Risk Difference (RD)|43.59|||=|0.056|TWO_SIDED|95.0|0.81|73.35|||Barnard's test||95% confidence interval (CI) of the difference in percentage was calculated using Miettinen-Nurminen method.|||73.35|0.81|=0.056
71077205|NCT04278924|141664020|SUPERIORITY||Risk Difference (RD)|39.42|||=|0.088|TWO_SIDED|95.0|-4.24|71.38|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||71.38|-4.24|=0.088
71077206|NCT04278924|141664020|SUPERIORITY||Risk Difference (RD)|67.83|||=|0.001|TWO_SIDED|95.0|29.21|87.29|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||87.29|29.21|=0.001
71077207|NCT04278924|141664021|SUPERIORITY||Risk Difference (RD)|55.56|||=|0.001|TWO_SIDED|95.0|25.11|81.51|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||81.51|25.11|=0.001
71077208|NCT04278924|141664021|SUPERIORITY||Risk Difference (RD)|50.0|||=|0.004|TWO_SIDED|95.0|19.63|78.95|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||78.95|19.63|=0.004
71077209|NCT04278924|141664021|SUPERIORITY||Risk Difference (RD)|81.82|||<|0.001|TWO_SIDED|95.0|51.24|94.99|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||94.99|51.24|<0.001
71077210|NCT04278924|141664022|SUPERIORITY||Risk Difference (RD)|35.9|||=|0.12|TWO_SIDED|95.0|-7.22|67.75|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||67.75|-7.22|=0.120
71077211|NCT04278924|141664022|SUPERIORITY||Risk Difference (RD)|44.23|||=|0.06|TWO_SIDED|95.0|-0.83|73.77|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||73.77|-0.83|=0.060
71077212|NCT04278924|141664022|SUPERIORITY||Risk Difference (RD)|60.14|||=|0.003|TWO_SIDED|95.0|21.33|82.42|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||82.42|21.33|=0.003
71077213|NCT04278924|141664023|SUPERIORITY||Risk Difference (RD)|40.0|||=|0.187|TWO_SIDED|95.0|-16.28|78.17|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||78.17|-16.28|=0.187
71077214|NCT04278924|141664023|SUPERIORITY||Risk Difference (RD)|25.0|||=|0.315|TWO_SIDED|95.0|-28.85|71.78|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||71.78|-28.85|=0.315
71077215|NCT04278924|141664023|SUPERIORITY||Risk Difference (RD)|100.0|||=|0.004|TWO_SIDED|95.0|35.12|100.0|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||100.00|35.12|=0.004
71077216|NCT05600036|141664024|SUPERIORITY|||||||0.0025|||||||Cochran-Mantel-Haenszel|||||||0.0025
71077217|NCT05600036|141664024|SUPERIORITY|||||||0.0001|||||||Cochran-Mantel-Haenszel|||||||0.0001
71077218|NCT05600036|141664024|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71077219|NCT05600036|141664024|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71077220|NCT05600036|141664024|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71077221|NCT01006590|141664035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.26|TWO_SIDED|95.0|-0.26|0.07|||ANCOVA|With baseline value as covariate and treatment group as factor; comparison of LSmeans for treatment||The null hypothesis H0: µt-µC=0, where μT denotes the mean absolute change in HbA1c from baseline to Week 24 in the group of patients treated with saxagliptin (test medication, T) and μC the mean absolute change in HbA1c from baseline to Week 24 in the group of patients with uptitration of metformin (comparator, C) A sample size of 120 randomized and treated patients per treatment group yielded 80% power under the assumption of a true treatment difference of 0.4% and a standard deviation of 1.1%||0.07|-0.26|0.26
71077222|NCT01006590|141664036|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.8|STANDARD_ERROR_OF_MEAN|5.79||0.3202|TWO_SIDED|95.0|-5.6|17.1|||Regression, Logistic|||||17.1|-5.6|0.3202
71077223|NCT01006590|141664037|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.3|STANDARD_ERROR_OF_MEAN|4.58||0.6203|TWO_SIDED|95.0|-6.7|11.3|||Regression, Logistic|||||11.3|-6.7|0.6203
71077224|NCT01006590|141664038|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.23||0.7627|TWO_SIDED|95.0|-0.38|0.52|||ANCOVA|||||0.52|-0.38|0.7627
71077225|NCT01006590|141664039|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|1.19||0.7701|TWO_SIDED|95.0|-2.0|2.7|||ANCOVA|||||2.7|-2.0|0.7701
71077226|NCT01006590|141664040|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.39|STANDARD_ERROR_OF_MEAN|4.34||0.5882|TWO_SIDED|95.0|-6.22|10.93|||ANCOVA|||||10.93|-6.22|0.5882
71078850|NCT01964716|141665735|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.03|||||TWO_SIDED|97.5|0.87|1.21||||||Serotype 9V: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.21|0.87|
71077227|NCT00703118|141664051|SUPERIORITY_OR_OTHER||Difference in percentage of response|46.8|||<|0.001|TWO_SIDED|95.0|36.8|56.7||Overall significance level was set at 5% (two-sided). Adjustment of significance level for multiple comparisons was carried out using the Hochberg procedure|Regression, Logistic|Included: treatment, type of prior response (relapser, partial responder, null-responder) and their interaction, and baseline HCV RNA as a covariate|Difference in percentage of response was estimated through the logistic regression model.|Null hypothesis: Assuming a 55% response rate in the groups receiving Treatment T12/PR48, a 29% response rate in the group receiving Treatment Pbo/PR48, a 2-sided continuity corrected Chi-squared test, with an overall significance level of 5% and a 2:2:1 randomization, a sample size of 140 patients receiving Treatment T12/PR48 and 70 patients in receiving Treatment Pbo/PR48 provided a power of approximately 90% to demonstrate a statistically significant difference.||56.7|36.8|<0.001
71077228|NCT00703118|141664051|SUPERIORITY_OR_OTHER||Difference in percentage of response|49.8|||<|0.001|TWO_SIDED|95.0|39.9|59.7||Overall significance level was set at 5% (two-sided). Adjustment of significance level for multiple comparisons was carried out using the Hochberg procedure|Regression, Logistic|Included: treatment, type of prior response (relapser, partial responder, null-responder) and their interaction, and baseline HCV RNA as a covariate|Difference in percentage of response was estimated through the logistic regression model.|Null hypothesis: Assuming a 55% response rate in the groups receiving Treatment T12/PR48 or T12(DS)/PR48, a 29% response rate in the group receiving Treatment Pbo/PR48, a 2-sided continuity corrected Chi-squared test, with an overall significance level of 5% and a 2:2:1 randomization, a sample size of 140 patients receiving Treatment T12(DS)/PR48 and 70 patients in receiving Treatment Pbo/PR48 provided a power of approximately 90% to demonstrate a statistically significant difference.||59.7|39.9|<0.001
71077229|NCT03714776|141664067|SUPERIORITY||||||<|0.001||||||P-value of analysis of variance (ANOVA) with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||||||<0.001
71077230|NCT03714776|141664068|SUPERIORITY|||||||0.454||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 3||||0.454
71077231|NCT03714776|141664068|SUPERIORITY|||||||0.909||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 8||||0.909
71077232|NCT03714776|141664068|SUPERIORITY|||||||0.132||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 15||||0.132
71077233|NCT03714776|141664068|SUPERIORITY|||||||0.659||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 22||||0.659
71077234|NCT03714776|141664068|SUPERIORITY|||||||0.474||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 29||||0.474
71077235|NCT03714776|141664068|SUPERIORITY|||||||0.483||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 36||||0.483
71077236|NCT03714776|141664069|SUPERIORITY|||||||0.064||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 3||||0.064
71077237|NCT03714776|141664069|SUPERIORITY||||||<|0.001||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 8||||<0.001
71117360|NCT01559259|141740583|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.09|||<|0.001|TWO_SIDED|95.0|1.57|2.6||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.60|1.57|<0.001
71117361|NCT01559259|141740583|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.44||||0.016|TWO_SIDED|95.0|0.08|0.81||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||0.81|0.08|0.016
71117362|NCT01559259|141740583|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.14||||0.428|TWO_SIDED|95.0|-0.21|0.5||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||0.50|-0.21|0.428
71117363|NCT01559259|141740583|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.47||||0.01|TWO_SIDED|95.0|0.11|0.84||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||0.84|0.11|0.010
71117364|NCT01559259|141740583|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|8.38|||<|0.001|TWO_SIDED|95.0|6.59|10.18||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||10.18|6.59|<0.001
71117365|NCT01559259|141740583|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|7.68|||<|0.001|TWO_SIDED|95.0|5.89|9.47||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||9.47|5.89|<0.001
71117366|NCT01559259|141740583|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|8.7|||<|0.001|TWO_SIDED|95.0|6.91|10.5||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||10.50|6.91|<0.001
71117367|NCT01559259|141740583|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|7.65|||<|0.001|TWO_SIDED|95.0|5.86|9.44||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||9.44|5.86|<0.001
71117368|NCT01559259|141740583|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.74||||0.25|TWO_SIDED|95.0|-0.52|1.99||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.99|-0.52|0.250
71117369|NCT01559259|141740583|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.04||||0.956|TWO_SIDED|95.0|-1.21|1.28||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.28|-1.21|0.956
71117370|NCT01559259|141740583|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.06||||0.099|TWO_SIDED|95.0|-0.2|2.31||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.31|-0.20|0.099
71117371|NCT01559259|141740583|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|10.22|||<|0.001|TWO_SIDED|95.0|7.78|12.66||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||12.66|7.78|<0.001
71117372|NCT01559259|141740583|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|9.49|||<|0.001|TWO_SIDED|95.0|7.06|11.92||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||11.92|7.06|<0.001
71117373|NCT01559259|141740583|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|10.72|||<|0.001|TWO_SIDED|95.0|8.28|13.15||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||13.15|8.28|<0.001
71117374|NCT01559259|141740583|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|9.63|||<|0.001|TWO_SIDED|95.0|7.19|12.06||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||12.06|7.19|<0.001
71117375|NCT01559259|141740583|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.6||||0.492|TWO_SIDED|95.0|-1.11|2.3||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.30|-1.11|0.492
71117376|NCT01559259|141740583|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.14||||0.873|TWO_SIDED|95.0|-1.83|1.56||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.56|-1.83|0.873
71117377|NCT01559259|141740583|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.09||||0.21|TWO_SIDED|95.0|-0.62|2.79||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.79|-0.62|0.210
71077238|NCT03714776|141664069|SUPERIORITY||||||<|0.001||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 15||||<0.001
71077239|NCT03714776|141664069|SUPERIORITY||||||<|0.001||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 22||||<0.001
71117378|NCT01559259|141740583|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|11.65|||<|0.001|TWO_SIDED|95.0|8.1|15.2||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||15.20|8.10|<0.001
71117379|NCT01559259|141740583|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|10.94|||<|0.001|TWO_SIDED|95.0|7.4|14.48||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||14.48|7.40|<0.001
71117380|NCT01559259|141740583|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|12.65|||<|0.001|TWO_SIDED|95.0|9.1|16.2||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||16.20|9.10|<0.001
71117381|NCT01559259|141740583|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|11.72|||<|0.001|TWO_SIDED|95.0|8.18|15.26||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||15.26|8.18|<0.001
71117382|NCT01559259|141740583|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.07||||0.957|TWO_SIDED|95.0|-2.55|2.42||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.42|-2.55|0.957
71117383|NCT01559259|141740583|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.78||||0.534|TWO_SIDED|95.0|-3.25|1.69||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.69|-3.25|0.534
71117384|NCT01559259|141740583|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.93||||0.462|TWO_SIDED|95.0|-1.55|3.41||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.41|-1.55|0.462
70941219|NCT03906240|141382433|SUPERIORITY||Cohen's d|0.25||||0.27|TWO_SIDED|95.0|-0.17|0.79|||t-test, 2 sided|t = 1.14||Psychological Domain: Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||0.79|-0.17|.270
71077240|NCT03714776|141664069|SUPERIORITY||||||<|0.001||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 29||||<0.001
71077241|NCT03714776|141664069|SUPERIORITY||||||<|0.001||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 36||||<0.001
71117385|NCT01559259|141740584|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|9.06|||<|0.001|TWO_SIDED|95.0|7.23|10.89||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||10.89|7.23|<0.001
71117386|NCT01559259|141740584|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|8.14|||<|0.001|TWO_SIDED|95.0|6.33|9.95||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||9.95|6.33|<0.001
71117387|NCT01559259|141740584|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|8.66|||<|0.001|TWO_SIDED|95.0|6.83|10.49||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||10.49|6.83|<0.001
71117388|NCT01559259|141740584|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|7.61|||<|0.001|TWO_SIDED|95.0|5.78|9.44||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||9.44|5.78|<0.001
71077242|NCT00548249|141664083|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.0||||0.999|TWO_SIDED|95.0|0.3|3.32||p-value not adjusted for multiple comparisons|Log Rank|||Hazard ratio with 95% confidence intervals comparing each SFP treatment group to placebo, and p-value from cox proportional hazards model||3.32|0.30|0.999
71077243|NCT00548249|141664083|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.17||||0.807|TWO_SIDED|95.0|0.33|4.09|||Log Rank|||||4.09|0.33|0.807
70853872|NCT04525885|141195710|SUPERIORITY|Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|Estimated Relative Reduction (%)|8.7||||0.713|TWO_SIDED|95.0|-30.51|70.03|||ANCOVA||Estimated relative reduction (ERR) relative to placebo was calculated by 100 (e\*\*DIFF -1), where e\*\*DIFF=exponent of difference; and DIFF= treatment difference in change from baseline at Week 24 based on log transformed data.|||70.03|-30.51|0.713
71077244|NCT00548249|141664083|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.8||||0.748|TWO_SIDED|95.0|0.21|3.02|||Log Rank|||||3.02|0.21|0.748
71117389|NCT01559259|141740584|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.45||||0.024|TWO_SIDED|95.0|0.19|2.7||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.70|0.19|0.024
71077245|NCT00548249|141664083|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.77||||0.299|TWO_SIDED|95.0|0.6|5.19|||Log Rank|||||5.19|0.60|0.299
71077246|NCT00548249|141664084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.234||95.0||||Threshold for statistical significance p \< 0.05|ANOVA|||Each dose was compared to placebo using an ANOVA model with treatment as the effect.||||0.234
71077247|NCT00548249|141664084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.049||95.0||||Threshold for statistical significance p \< 0.05|ANOVA|||Each dose was compared to placebo using an ANOVA model with treatment as the effect||||0.049
71077248|NCT00548249|141664084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.375||95.0||||Threshold for statistical significance p \< 0.05|ANOVA|||Each dose was compared to placebo using an ANOVA model with treatment as the effect||||0.375
71077249|NCT00548249|141664084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.625||95.0||||Threshold for statistical significance p \< 0.05|ANOVA|||Each dose was compared to placebo using an ANOVA model with treatment as the effect||||0.625
71077250|NCT00938587|141664089|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.291||0.0141|TWO_SIDED|90.0|-1.21|-0.24|||MMRM|||Day 14: Treatment difference and its corresponding 90 percent (%) confidence interval (CI) was based on least squares (LS) mean difference using mixed-model repeated measure (MMRM) where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and compound symmetry (CS) as covariance structure.||-0.24|-1.21|0.0141
71117390|NCT01559259|141740584|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.53||||0.392|TWO_SIDED|95.0|-0.69|1.76||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.76|-0.69|0.392
71077251|NCT00938587|141664089|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.26|STANDARD_ERROR_OF_MEAN|0.283|<|0.0001|TWO_SIDED|90.0|-1.73|-0.79|||MMRM|||Day 14: Treatment difference and its corresponding 90 % CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.79|-1.73|<0.0001
71077252|NCT00938587|141664090|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.45|STANDARD_ERROR_OF_MEAN|1.865||0.437|TWO_SIDED|90.0|-4.54|1.63|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.63|-4.54|0.4370
71077253|NCT00938587|141664090|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.5|STANDARD_ERROR_OF_MEAN|1.858||0.1802|TWO_SIDED|90.0|-5.58|0.57|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.57|-5.58|0.1802
71077254|NCT00938587|141664090|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.96|STANDARD_ERROR_OF_MEAN|1.832||0.6012|TWO_SIDED|90.0|-3.99|2.07|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.07|-3.99|0.6012
71077255|NCT00938587|141664090|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.01|STANDARD_ERROR_OF_MEAN|1.834||0.2753|TWO_SIDED|90.0|-5.04|1.03|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.03|-5.04|0.2753
71077256|NCT00938587|141664090|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.49|STANDARD_ERROR_OF_MEAN|1.844||0.7892|TWO_SIDED|90.0|-2.56|3.55|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.55|-2.56|0.7892
71077257|NCT00938587|141664090|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.72|STANDARD_ERROR_OF_MEAN|1.937||0.3765|TWO_SIDED|90.0|-4.92|1.49|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.49|-4.92|0.3765
71077258|NCT00938587|141664090|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.59|STANDARD_ERROR_OF_MEAN|1.873||0.0571|TWO_SIDED|90.0|-6.69|-0.49|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.49|-6.69|0.0571
71077259|NCT00938587|141664090|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.85|STANDARD_ERROR_OF_MEAN|1.896||0.6553|TWO_SIDED|90.0|-3.99|2.29|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.29|-3.99|0.6553
71077260|NCT00938587|141664090|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.72|STANDARD_ERROR_OF_MEAN|1.847||0.1427|TWO_SIDED|90.0|-5.78|0.33|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.33|-5.78|0.1427
71077261|NCT00938587|141664090|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.87|STANDARD_ERROR_OF_MEAN|1.873||0.643|TWO_SIDED|90.0|-2.23|3.97|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.97|-2.23|0.6430
71077262|NCT00938587|141664090|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.04|STANDARD_ERROR_OF_MEAN|1.918||0.5868|TWO_SIDED|90.0|-2.13|4.22|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||4.22|-2.13|0.5868
71077263|NCT00938587|141664090|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.02|STANDARD_ERROR_OF_MEAN|1.873||0.586|TWO_SIDED|90.0|-4.12|2.08|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.08|-4.12|0.5860
71077264|NCT00938587|141664090|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.84|STANDARD_ERROR_OF_MEAN|1.879||0.3288|TWO_SIDED|90.0|-1.27|4.95|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||4.95|-1.27|0.3288
71077265|NCT00938587|141664090|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|1.846||0.9027|TWO_SIDED|90.0|-3.28|2.83|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.83|-3.28|0.9027
71077266|NCT00938587|141664090|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.8|STANDARD_ERROR_OF_MEAN|1.871||0.671|TWO_SIDED|90.0|-2.3|3.89|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.89|-2.30|0.6710
71117739|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|4.29||||0.548|TWO_SIDED|95.0|-9.8|18.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.38|-9.80|0.548
71117391|NCT01559259|141740584|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.05||||0.101|TWO_SIDED|95.0|-0.21|2.3||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.30|-0.21|0.101
71117392|NCT01559259|141740584|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|30.23|||<|0.001|TWO_SIDED|95.0|23.97|36.48||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||36.48|23.97|<0.001
71117393|NCT01559259|141740584|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|27.93|||<|0.001|TWO_SIDED|95.0|21.74|34.11||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||34.11|21.74|<0.001
71117394|NCT01559259|141740584|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|29.86|||<|0.001|TWO_SIDED|95.0|23.6|36.12||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||36.12|23.60|<0.001
71117395|NCT01559259|141740584|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|27.59|||<|0.001|TWO_SIDED|95.0|21.33|33.86||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||33.86|21.33|<0.001
71117396|NCT01559259|141740584|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.63||||0.228|TWO_SIDED|95.0|-1.65|6.92||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||6.92|-1.65|0.228
71117397|NCT01559259|141740584|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.33||||0.875|TWO_SIDED|95.0|-3.84|4.51||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.51|-3.84|0.875
71117398|NCT01559259|141740584|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.27||||0.299|TWO_SIDED|95.0|-2.02|6.55||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||6.55|-2.02|0.299
71117399|NCT01559259|141740584|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|36.98|||<|0.001|TWO_SIDED|95.0|28.48|45.47||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||45.47|28.48|<0.001
71117400|NCT01559259|141740584|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|35.1|||<|0.001|TWO_SIDED|95.0|26.7|43.5||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||43.50|26.70|<0.001
71117401|NCT01559259|141740584|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|37.09|||<|0.001|TWO_SIDED|95.0|28.6|45.59||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||45.59|28.60|<0.001
71117402|NCT01559259|141740584|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|35.17|||<|0.001|TWO_SIDED|95.0|26.67|43.68||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||43.68|26.67|<0.001
71117403|NCT01559259|141740584|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.8||||0.543|TWO_SIDED|95.0|-4.02|7.63||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||7.63|-4.02|0.543
70941220|NCT03906240|141382434|SUPERIORITY||Cohen's d|0.08||||0.768|TWO_SIDED|95.0|-0.45|0.71|||t-test, 2 sided|t = 0.30||Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||0.71|-0.45|.768
71077267|NCT00938587|141664091|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.23|STANDARD_ERROR_OF_MEAN|1.123||0.837|TWO_SIDED|90.0|-1.63|2.09|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.09|-1.63|0.8370
71077268|NCT00938587|141664091|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.96|STANDARD_ERROR_OF_MEAN|1.12||0.0819|TWO_SIDED|90.0|-3.81|-0.11|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.11|-3.81|0.0819
71077269|NCT00938587|141664091|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|1.106||0.8892|TWO_SIDED|90.0|-1.98|1.67|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.67|-1.98|0.8892
71077270|NCT00938587|141664091|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.35|STANDARD_ERROR_OF_MEAN|1.106||0.0353|TWO_SIDED|90.0|-4.17|-0.52|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.52|-4.17|0.0353
71077271|NCT00938587|141664091|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|1.108||0.7283|TWO_SIDED|90.0|-2.22|1.45|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.45|-2.22|0.7283
71077272|NCT00938587|141664091|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|1.174||0.9083|TWO_SIDED|90.0|-1.81|2.08|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.08|-1.81|0.9083
71077273|NCT00938587|141664091|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.58|STANDARD_ERROR_OF_MEAN|1.132||0.1641|TWO_SIDED|90.0|-3.45|0.29|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.29|-3.45|0.1641
71077274|NCT00938587|141664091|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.27|STANDARD_ERROR_OF_MEAN|1.155||0.817|TWO_SIDED|90.0|-1.64|2.18|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.18|-1.64|0.8170
71077275|NCT00938587|141664091|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.45|STANDARD_ERROR_OF_MEAN|1.116||0.1958|TWO_SIDED|90.0|-3.29|0.4|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.40|-3.29|0.1958
71077276|NCT00938587|141664091|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.13|STANDARD_ERROR_OF_MEAN|1.13||0.907|TWO_SIDED|90.0|-1.74|2.0|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.00|-1.74|0.9070
71077277|NCT00938587|141664091|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.58|STANDARD_ERROR_OF_MEAN|1.16||0.0023|TWO_SIDED|90.0|1.67|5.5|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||5.50|1.67|0.0023
71077278|NCT00938587|141664091|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.62|STANDARD_ERROR_OF_MEAN|1.132||0.1531|TWO_SIDED|90.0|-0.25|3.49|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.49|-0.25|0.1531
70941221|NCT03906240|141382434|SUPERIORITY||Cohen's d|0.01||||0.975|TWO_SIDED|95.0|-0.53|0.42|||t-test, 2 sided|t = 0.05||Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||0.42|-0.53|.975
71077279|NCT00938587|141664091|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.65|STANDARD_ERROR_OF_MEAN|1.141||0.1506|TWO_SIDED|90.0|-0.24|3.53|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.53|-0.24|0.1506
71077280|NCT00938587|141664091|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|1.116||0.78|TWO_SIDED|90.0|-2.16|1.53|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.53|-2.16|0.7800
71077281|NCT00938587|141664091|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.94|STANDARD_ERROR_OF_MEAN|1.13||0.0883|TWO_SIDED|90.0|-3.8|-0.07|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.07|-3.80|0.0883
70941222|NCT02162771|141382478|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed values were used to assess the bioequivalence between CT-P10 and Rituxan (bioequivalence range of 80% to 125%)|Ratio of geometric least square means|102.25|||||TWO_SIDED|90.0|94.05|111.17|||ANCOVA|Country, gender, race, the value of ECOG status and the FLIPI score (0 to 2 versus 3 to 5) at baseline were fitted as covariates.||Equivalence in AUCtau between CT-P10 and Rituxan||111.17|94.05|
71117404|NCT01559259|141740584|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.07||||0.979|TWO_SIDED|95.0|-5.75|5.6||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||5.60|-5.75|0.979
71117405|NCT01559259|141740584|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.92||||0.517|TWO_SIDED|95.0|-3.9|7.74||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||7.74|-3.90|0.517
71117406|NCT01559259|141740584|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|42.96|||<|0.001|TWO_SIDED|95.0|30.51|55.41||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||55.41|30.51|<0.001
71117407|NCT01559259|141740584|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|42.2|||<|0.001|TWO_SIDED|95.0|29.9|54.51||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||54.51|29.90|<0.001
71117408|NCT01559259|141740584|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|45.12|||<|0.001|TWO_SIDED|95.0|32.67|57.57||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||57.57|32.67|<0.001
71117409|NCT01559259|141740584|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|44.25|||<|0.001|TWO_SIDED|95.0|31.79|56.71||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||56.71|31.79|<0.001
71117410|NCT01559259|141740584|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.29||||0.767|TWO_SIDED|95.0|-9.82|7.25||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||7.25|-9.82|0.767
71117411|NCT01559259|141740584|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-2.04||||0.629|TWO_SIDED|95.0|-10.36|6.27||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||6.27|-10.36|0.629
71117412|NCT01559259|141740584|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.87||||0.841|TWO_SIDED|95.0|-7.66|9.39||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||9.39|-7.66|0.841
71117413|NCT01559259|141740585|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.97|||<|0.001|TWO_SIDED|95.0|3.22|4.73||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.73|3.22|<0.001
71117414|NCT01559259|141740585|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.64|||<|0.001|TWO_SIDED|95.0|2.88|4.39||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.39|2.88|<0.001
71117415|NCT01559259|141740585|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.07|||<|0.001|TWO_SIDED|95.0|3.32|4.83||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.83|3.32|<0.001
71117416|NCT01559259|141740585|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.39|||<|0.001|TWO_SIDED|95.0|2.64|4.14||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.14|2.64|<0.001
71077282|NCT00938587|141664092|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.47|STANDARD_ERROR_OF_MEAN|4.48||0.0599|TWO_SIDED|90.0|-15.87|-1.07|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-1.07|-15.87|0.0599
71077283|NCT00938587|141664092|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-13.29|STANDARD_ERROR_OF_MEAN|4.436||0.003|TWO_SIDED|90.0|-20.61|-5.96|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-5.96|-20.61|0.0030
71077284|NCT00938587|141664092|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-12.63|STANDARD_ERROR_OF_MEAN|4.483||0.0053|TWO_SIDED|90.0|-20.03|-5.22|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-5.22|-20.03|0.0053
71077285|NCT00938587|141664092|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-17.44|STANDARD_ERROR_OF_MEAN|4.445||0.0001|TWO_SIDED|90.0|-24.78|-10.1|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-10.10|-24.78|0.0001
71077286|NCT00938587|141664092|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.15|STANDARD_ERROR_OF_MEAN|4.427||0.3492|TWO_SIDED|90.0|-11.46|3.16|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.16|-11.46|0.3492
71077287|NCT00938587|141664092|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.68|STANDARD_ERROR_OF_MEAN|4.661||0.0389|TWO_SIDED|90.0|-17.38|-1.98|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure||-1.98|-17.38|0.0389
71077288|NCT00938587|141664092|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-11.1|STANDARD_ERROR_OF_MEAN|4.49||0.0142|TWO_SIDED|90.0|-18.51|-3.68|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-3.68|-18.51|0.0142
71077289|NCT00938587|141664092|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-13.51|STANDARD_ERROR_OF_MEAN|4.612||0.0037|TWO_SIDED|90.0|-21.13|-5.89|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-5.89|-21.13|0.0037
71077290|NCT00938587|141664092|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-14.93|STANDARD_ERROR_OF_MEAN|4.447||0.0009|TWO_SIDED|90.0|-22.27|-7.58|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-7.58|-22.27|0.0009
71077291|NCT00938587|141664092|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.83|STANDARD_ERROR_OF_MEAN|4.484||0.3939|TWO_SIDED|90.0|-11.23|3.57|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.57|-11.23|0.3939
71077292|NCT00938587|141664092|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|11.54|STANDARD_ERROR_OF_MEAN|4.595||0.0127|TWO_SIDED|90.0|3.95|19.13|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||19.13|3.95|0.0127
71077293|NCT00938587|141664092|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.32|STANDARD_ERROR_OF_MEAN|4.49||0.9425|TWO_SIDED|90.0|-7.09|7.74|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||7.74|-7.09|0.9425
71077294|NCT00938587|141664092|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|11.08|STANDARD_ERROR_OF_MEAN|4.544||0.0155|TWO_SIDED|90.0|3.58|18.59|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||18.59|3.58|0.0155
71077295|NCT00938587|141664092|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|4.447||0.9757|TWO_SIDED|90.0|-7.48|7.21|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||7.21|-7.48|0.9757
71077296|NCT00938587|141664092|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.46|STANDARD_ERROR_OF_MEAN|4.484||0.9184|TWO_SIDED|90.0|-7.86|6.94|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||6.94|-7.86|0.9184
71077297|NCT00938587|141664093|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.135||0.2403|TWO_SIDED|90.0|-0.38|0.06|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.06|-0.38|0.2403
70853873|NCT04525885|141195713|SUPERIORITY||Estimated Relative Reduction (%)|11.58||||0.628|TWO_SIDED|95.0|-28.68|74.57||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA||Estimated relative reduction (ERR) relative to placebo was calculated by 100 (e\*\*DIFF -1), where e\*\*DIFF=exponent of difference; and DIFF= treatment difference in change from baseline at Week 24 based on log transformed data.|||74.57|-28.68|0.628
70853874|NCT04525885|141195714|SUPERIORITY||Odds Ratio (OR)|0.96||||0.917|TWO_SIDED|95.0|0.43|2.13||Comparison based on logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, baseline LCQ total score, and the interaction of baseline LCQ total score by visit as covariates.|Regression, Logistic|||||2.13|0.43|0.917
70853875|NCT04525885|141195715|SUPERIORITY||Odds Ratio (OR)|0.85||||0.687|TWO_SIDED|95.0|0.38|1.88||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, baseline 24-hour coughs per hour and the interaction of baseline 24-hour coughs per hour by visit as covariates.|Regression, Logistic|||||1.88|0.38|0.687
70853876|NCT04525885|141195716|OTHER||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.49|2.49||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, baseline mean weekly CSD total score and the interaction of baseline mean weekly CSD total score by visit as covariates.||2.49|0.49|
70853877|NCT04525885|141195717|OTHER||Odds Ratio (OR)|1.93|||||TWO_SIDED|95.0|0.8|4.64||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, baseline mean weekly CSD total score, and the interaction of baseline mean weekly CSD total score by visit as covariates||4.64|0.80|
70941223|NCT02162771|141382479|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed transformed values were used to assess the bioequivalence between CT-P10 and Rituxan (bioequivalence range of 80% to 125%)|Ratio of geometric least square means|100.67|||||TWO_SIDED|90.0|93.84|108.0|||ANCOVA|Country, gender, race, the value of ECOG status and the FLIPI score (0 to 2 versus 3 to 5) at baseline were fitted as covariates.||Equivalence in Cmax,ss between CT-P10 and Rituxan||108.00|93.84|
70941224|NCT02162771|141382480|NON_INFERIORITY|Non-inferiority margin of -7% was predefined.|Point estimate difference|4.3|||||TWO_SIDED|||||||||||||
70941225|NCT03594266|141382507|OTHER||||||<|0.0001|||||||paired t-test, two-sided|||||||<0.0001
71077298|NCT00938587|141664093|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.134||0.027|TWO_SIDED|90.0|-0.52|-0.08|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.08|-0.52|0.0270
70853878|NCT04525885|141195718|OTHER|Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, baseline mean weekly VAS score, and the interaction of baseline mean weekly VAS score by visit as covariates.|Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.45|2.72||||||||2.72|0.45|
70853879|NCT00978757|141195729|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
71077299|NCT00938587|141664093|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.133||0.3139|TWO_SIDED|90.0|-0.36|0.09|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.09|-0.36|0.3139
71077300|NCT00938587|141664093|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.134||0.0415|TWO_SIDED|90.0|-0.5|-0.05|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.05|-0.50|0.0415
70853880|NCT03137069|141195750|SUPERIORITY||Least Squares Mean Difference|-7.02||||0.0559|TWO_SIDED|90.0|-13.01|-1.03|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||-1.03|-13.01|0.0559
70853881|NCT03137069|141195750|SUPERIORITY||Least Squares Mean Difference|-0.51||||0.8892|TWO_SIDED|90.0|-6.6|5.58|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||5.58|-6.60|0.8892
70853882|NCT03137069|141195750|SUPERIORITY||Least Squares Mean Difference|-6.43||||0.0717|TWO_SIDED|90.0|-12.29|-0.57|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||-0.57|-12.29|0.0717
70853883|NCT03137069|141195750|SUPERIORITY||Least Squares Mean Difference|-9.53||||0.0097|TWO_SIDED|90.0|-15.5|-3.55|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||-3.55|-15.50|0.0097
70853884|NCT03137069|141195751|SUPERIORITY|||||||0.1087|||||||Cochran-Mantel-Haenszel|Stratified by region||||||0.1087
70853885|NCT03137069|141195751|SUPERIORITY|||||||0.3418|||||||Cochran-Mantel-Haenszel|Stratified by region||||||0.3418
70853886|NCT03137069|141195751|SUPERIORITY|||||||0.0459|||||||Cochran-Mantel-Haenszel|Stratified by region||||||0.0459
70853887|NCT03137069|141195751|SUPERIORITY|||||||0.019|||||||Cochran-Mantel-Haenszel|Stratified by region||||||0.0190
70853888|NCT03137069|141195752|SUPERIORITY||Least Squares Mean Difference|-12.88||||0.001|TWO_SIDED|90.0|-18.94|-6.82|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||-6.82|-18.94|0.0010
70853889|NCT03137069|141195752|SUPERIORITY||Least Squares Mean Difference|-2.83||||0.4565|TWO_SIDED|90.0|-9.11|3.46|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||3.46|-9.11|0.4565
70941226|NCT03594266|141382507|OTHER||||||<|0.0001|||||||paired t-test, two-sided|||||||<0.0001
70941227|NCT03594266|141382508|OTHER|||||||0.5482|||||||two-sample t-test, 2-sided|||||||0.5482
71077301|NCT00938587|141664093|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.134||0.8585|TWO_SIDED|90.0|-0.2|0.25|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.25|-0.20|0.8585
70853890|NCT03137069|141195752|SUPERIORITY||Least Squares Mean Difference|-5.03||||0.1711|TWO_SIDED|90.0|-11.1|1.03|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||1.03|-11.10|0.1711
70853891|NCT03137069|141195752|SUPERIORITY||Least Squares Mean Difference|-10.76||||0.005|TWO_SIDED|90.0|-16.97|-4.56|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||-4.56|-16.97|0.0050
71077302|NCT00938587|141664093|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.138||0.7284|TWO_SIDED|90.0|-0.28|0.18|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.18|-0.28|0.7284
71077303|NCT00938587|141664093|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.135||0.0171|TWO_SIDED|90.0|-0.55|-0.1|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.10|-0.55|0.0171
71077304|NCT00938587|141664093|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.135||0.2277|TWO_SIDED|90.0|-0.39|0.06|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.06|-0.39|0.2277
71077305|NCT00938587|141664093|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.134||0.0013|TWO_SIDED|90.0|-0.67|-0.22|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.22|-0.67|0.0013
71077306|NCT00938587|141664093|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.135||0.3908|TWO_SIDED|90.0|-0.34|0.11|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.11|-0.34|0.3908
71077307|NCT00938587|141664094|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.66|STANDARD_ERROR_OF_MEAN|7.093||0.6067|TWO_SIDED|90.0|-15.43|8.1|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||8.10|-15.43|0.6067
71077308|NCT00938587|141664094|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.55|STANDARD_ERROR_OF_MEAN|7.101||0.1816|TWO_SIDED|90.0|-21.32|2.23|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.23|-21.32|0.1816
71077309|NCT00938587|141664094|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.84|STANDARD_ERROR_OF_MEAN|7.029||0.6873|TWO_SIDED|90.0|-14.5|8.82|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||8.82|-14.50|0.6873
71077310|NCT00938587|141664094|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.72|STANDARD_ERROR_OF_MEAN|7.052||0.2188|TWO_SIDED|90.0|-20.42|2.98|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.98|-20.42|0.2188
71077311|NCT00938587|141664094|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.83|STANDARD_ERROR_OF_MEAN|7.024||0.9067|TWO_SIDED|90.0|-10.82|12.47|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||12.47|-10.82|0.9067
71077312|NCT00938587|141664094|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.02|STANDARD_ERROR_OF_MEAN|7.254||0.5803|TWO_SIDED|90.0|-16.05|8.0|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||8.00|-16.05|0.5803
71077313|NCT00938587|141664094|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.29|STANDARD_ERROR_OF_MEAN|7.156||0.249|TWO_SIDED|90.0|-20.16|3.57|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.57|-20.16|0.2490
71077314|NCT00938587|141664094|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-11.62|STANDARD_ERROR_OF_MEAN|7.178||0.1081|TWO_SIDED|90.0|-23.52|0.28|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.28|-23.52|0.1081
71077315|NCT00938587|141664094|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-15.89|STANDARD_ERROR_OF_MEAN|7.098||0.0271|TWO_SIDED|90.0|-27.66|-4.12|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-4.12|-27.66|0.0271
71077316|NCT00938587|141664094|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.6|STANDARD_ERROR_OF_MEAN|7.121||0.2881|TWO_SIDED|90.0|-19.41|4.21|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||4.21|-19.41|0.2881
71077317|NCT00938587|141664095|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-6.52|STANDARD_ERROR_OF_MEAN|7.059||0.3579|TWO_SIDED|90.0|-18.23|5.19|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||5.19|-18.23|0.3579
70853892|NCT02043899|141195764|OTHER|"1. Exact one-sided binomial test of the null hypothesis (p≤90%) using α=0.05 on \[124I\]mIBG PET/CT SIOPEN consensus scores. If this was accepted and the alternative hypothesis rejected, then trial stopped early for futility.~2. If the null hypothesis was rejected, then a one-sided binomial test of the null hypothesis (p≥97%) was performed (α=0.025). If this was accepted and the alternative hypothesis rejected then the trial stopped early for efficacy."|||||<|0.001||||||Overall design has 82% power and an α of 0.03. Total minimum sample size of 100 lesions was calculated based on a single stage A'hern design with p0 = 0.90 and p1 = 0.97. The overall power and α was calculated based on exact binomial probabilities.|Exact one-sided binomial test||||"For the primary endpoint, a sensitivity analysis was also performed on patients with \<20 positive lesions on \[124I\]mIBG PET/CT to test if few patients with large numbers of positive lesions were affecting the results. The results of the sensitivity analysis were consistent with those of the overall analysis.~Secondary efficacy analysis, separate exact one-sided binomial test of the null hypothesis (p≥97%), performed (α=0.025) performed for skeletal and soft tissue lesions."|||<0.001
70853893|NCT01954927|141195767|SUPERIORITY|||||||0.227||||||1-sided p-value|z-test Proportion|z-test of proportions without continuity correction||||||0.227
71077318|NCT00938587|141664095|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.55|STANDARD_ERROR_OF_MEAN|7.046||0.2274|TWO_SIDED|90.0|-20.24|3.14|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.14|-20.24|0.2274
71077319|NCT00938587|141664095|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-10.15|STANDARD_ERROR_OF_MEAN|6.973||0.1482|TWO_SIDED|90.0|-21.72|1.41|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.41|-21.72|0.1482
70853894|NCT01954927|141195768|SUPERIORITY|||||||0.897|||||||Wilcoxon (Mann-Whitney)|||||||0.897
71077320|NCT00938587|141664095|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-12.19|STANDARD_ERROR_OF_MEAN|6.962||0.0828|TWO_SIDED|90.0|-23.74|-0.64|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.64|-23.74|0.0828
71077321|NCT00938587|141664095|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.64|STANDARD_ERROR_OF_MEAN|6.953||0.6021|TWO_SIDED|90.0|-15.17|7.9|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||7.90|-15.17|0.6021
71077322|NCT00938587|141664095|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.28|STANDARD_ERROR_OF_MEAN|7.213||0.7528|TWO_SIDED|90.0|-14.24|9.68|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||9.68|-14.24|0.7528
71077323|NCT00938587|141664095|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.17|STANDARD_ERROR_OF_MEAN|7.1||0.2523|TWO_SIDED|90.0|-19.94|3.6|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.60|-19.94|0.2523
71077324|NCT00938587|141664095|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-11.63|STANDARD_ERROR_OF_MEAN|7.118||0.1049|TWO_SIDED|90.0|-23.43|0.17|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.17|-23.43|0.1049
71077325|NCT00938587|141664095|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-17.53|STANDARD_ERROR_OF_MEAN|7.006||0.0138|TWO_SIDED|90.0|-29.14|-5.91|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-5.91|-29.14|0.0138
71077326|NCT00938587|141664095|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.36|STANDARD_ERROR_OF_MEAN|7.052||0.1873|TWO_SIDED|90.0|-21.05|2.34|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.34|-21.05|0.1873
71077327|NCT00938587|141664096|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.54|STANDARD_ERROR_OF_MEAN|5.339||0.509|TWO_SIDED|90.0|-12.4|5.32|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||5.32|-12.40|0.5090
71077328|NCT00938587|141664096|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.89|STANDARD_ERROR_OF_MEAN|5.354||0.0998|TWO_SIDED|90.0|-17.78|-0.01|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.01|-17.78|0.0998
71117417|NCT01559259|141740585|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.58||||0.031|TWO_SIDED|95.0|0.05|1.11||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.11|0.05|0.031
70853895|NCT01954927|141195769|SUPERIORITY|||||||0.181|||||||Chi-squared|||||||0.181
70853896|NCT01954927|141195770|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.730
70853897|NCT01954927|141195771|SUPERIORITY|||||||0.713|||||||Chi-squared|||||||0.713
70853898|NCT01954927|141195772|SUPERIORITY|||||||0.739|||||||Wilcoxon (Mann-Whitney)|||||||0.739
70853899|NCT01954927|141195773|SUPERIORITY|||||||0.388|||||||Wilcoxon (Mann-Whitney)|||||||0.388
70853900|NCT00955305|141195784|SUPERIORITY_OR_OTHER|||||||0.33||||||one-sided p-value using stratified logrank test stratified on the randomization stratification factors|Log Rank|Stratified log rank test stratified on the randomization stratification factors||||||0.33
70853901|NCT00955305|141195785|SUPERIORITY_OR_OTHER|||||||0.95||||||two-sided p-value by stratified log rank test stratified on the randomization stratification factors|Log Rank|Stratified log rank test stratified on the randomization stratification factors||||||0.95
70853902|NCT00955305|141195786|SUPERIORITY_OR_OTHER|||||||0.15||||||two sided p-value by Fisher's exact test|Fisher Exact|||||||0.15
70853903|NCT00362180|141195813|SUPERIORITY_OR_OTHER|||||||0.7244|TWO_SIDED||||||exact Wilcoxon Rank-sum test|||The p-value is a comparison between the placebo group and the mipomersen group in Cohort E as a change from Baseline to Day 26.||||0.7244
70853904|NCT00362180|141195813|SUPERIORITY_OR_OTHER|||||||0.0513|TWO_SIDED||||||exact Wilcoxon Rank-sum test|||The p-value is a comparison between the placebo group and the mipomersen group in Cohort E as a change from Baseline to Day 99.||||0.0513
70853905|NCT03930264|141195821|EQUIVALENCE|For bioequivalence, the 90% CIs of the geometric mean ratio of Cmax for tablet and suspension were required to be within the 80 to 125% range.|Odds Ratio (OR)|1.12||||0.3008|TWO_SIDED|90.0|0.93|1.35|||ANOVA|||||1.35|0.93|0.3008
71117418|NCT01559259|141740585|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.24||||0.36|TWO_SIDED|95.0|-0.28|0.77||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||0.77|-0.28|0.360
71117419|NCT01559259|141740585|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.68||||0.011|TWO_SIDED|95.0|0.15|1.21||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.21|0.15|0.011
71117420|NCT01559259|141740585|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|13.14|||<|0.001|TWO_SIDED|95.0|10.54|15.73||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||15.73|10.54|<0.001
71117421|NCT01559259|141740585|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|11.94|||<|0.001|TWO_SIDED|95.0|9.35|14.52||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||14.52|9.35|<0.001
70853906|NCT03930264|141195822|EQUIVALENCE|For bioequivalence, the 90% CIs of the geometric mean ratio of AUC0-τ for tablet and suspension were required to be within the 80 to 125% range.|Ratio|1.06||||0.1061|TWO_SIDED|90.0|1.0|1.13|||ANOVA|||||1.13|1.00|0.1061
70853907|NCT03930264|141195823|EQUIVALENCE|For bioequivalence, the 90% CIs of the geometric mean ratio of AUC0-∞ for tablet and suspension were required to be within the 80 to 125% range.|Ratio|1.02||||0.5696|TWO_SIDED|90.0|0.96|1.09|||ANOVA|||||1.09|0.96|0.5696
70853908|NCT02434471|141195824|OTHER||Mean Difference (Final Values)|0.6|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
70853909|NCT02434471|141195825|OTHER||Mean Difference (Final Values)|0.1||||0.83|TWO_SIDED||||||Mixed Models Analysis|||||||0.83
70853910|NCT02204124|141195831|SUPERIORITY|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
70853911|NCT02204124|141195832|SUPERIORITY|||||||0.513|||||||Chi-squared|||||||0.513
70853912|NCT02204124|141195835|SUPERIORITY|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
70853913|NCT02204124|141195836|SUPERIORITY|||||||0.132|||||||Chi-squared|||||||0.132
70853914|NCT02204124|141195837|SUPERIORITY|||||||0.975|||||||Chi-squared|||Statistical analysis #1 is for readmission||||0.975
70853915|NCT02204124|141195837|SUPERIORITY|||||||0.401|||||||Chi-squared|||Statistical analysis #2 is for wound infection.||||0.401
70853916|NCT02204124|141195837|SUPERIORITY|||||||0.975|||||||Chi-squared|||Statistical analysis #3 is for gastroparesis.||||0.975
70853917|NCT02204124|141195837|SUPERIORITY|||||||0.401|||||||Chi-squared|||Statistical analysis #4 is for pancreatic fistula.||||0.401
70853918|NCT02204124|141195837|SUPERIORITY|||||||0.219|||||||Chi-squared|||Statistical analysis #5 is for intraabdominal abscess.||||0.219
70853919|NCT02204124|141195837|SUPERIORITY|||||||0.401|||||||Chi-squared|||Statistical analysis #6 is for anastomotic leakage.||||0.401
70853920|NCT02204124|141195837|SUPERIORITY|||||||0.219|||||||Chi-squared|||Statistical analysis #7 is for blood product transfusion (anemia).||||0.219
70853921|NCT01250496|141195838|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.45||||0.04|TWO_SIDED|95.0|0.2|0.98||No adjustment for multiple comparisons was performed. The threshold for statistical significance was \< 0.05|Chi-squared|||null hypothesis: aminophylline administration does not reduce the incidence of the primary endpoint as compared to placebo. The chi-square test was used to compare event rate between the study arm.||0.98|0.2|0.04
70853922|NCT01250496|141195839|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.39|||<|0.001|TWO_SIDED|95.0|0.2|0.7||P value is not adjusted for multiple comparisons.|Chi-squared|||"null hypothesis: the rate of regadenoson adverse effects (global symptomatic burden) in the aminophylline and placebo group are not statistically different.~The chi-square test was used for comparison."||0.7|0.2|< 0.001
70853923|NCT00791973|141195850|SUPERIORITY_OR_OTHER|||||||0.33|||||||Wilcoxon signed-rank test|||||||0.33
70853924|NCT00791973|141195851|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon signed-rank test|||||||0.14
70853925|NCT01128621|141195977|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.216|||||TWO_SIDED|95.0|-1.0|0.57||||||Placebo vs GSK1292263 75 mg: Day 7, pre-breakfast||0.57|-1.00|
70853926|NCT01128621|141195977|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.29|||||TWO_SIDED|95.0|-0.53|1.11||||||Placebo vs GSK1292263 300 mg: Day 7, pre-breakfast||1.11|-0.53|
70853927|NCT01128621|141195977|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.748|||||TWO_SIDED|95.0|-0.02|1.52||||||Placebo vs GSK1292263 600 mg: Day 7, pre-breakfast||1.52|-0.02|
70853928|NCT01128621|141195977|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.207|||||TWO_SIDED|95.0|-2.01|-0.41||||||Placebo vs Sitagliptin 50 mg: Day 7, pre-breakfast||-0.41|-2.01|
70853929|NCT01128621|141195977|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.991|||||TWO_SIDED|95.0|0.18|1.81||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 7 , pre-breakfast||1.81|0.18|
70853930|NCT01128621|141195977|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.497|||||TWO_SIDED|95.0|0.66|2.34||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 7, pre-breakfast||2.34|0.66|
70853931|NCT01128621|141195977|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.955|||||TWO_SIDED|95.0|1.16|2.75||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 7, pre-breakfast||2.75|1.16|
70853932|NCT01128621|141195977|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.78|||||TWO_SIDED|95.0|-1.74|0.18||||||Placebo vs GSK1292263 75 mg: Day 14, pre-breakfast||0.18|-1.74|
70853933|NCT01128621|141195977|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.188|||||TWO_SIDED|95.0|-0.81|1.19||||||Placebo vs GSK1292263 300 mg: Day 14, pre-breakfast||1.19|-0.81|
70853934|NCT01128621|141195977|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|||||TWO_SIDED|95.0|-0.35|1.55||||||Placebo vs GSK1292263 600 mg: Day 14, pre-breakfast||1.55|-0.35|
70853935|NCT01128621|141195977|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.069|||||TWO_SIDED|95.0|-2.05|-0.08||||||Placebo vs Sitagliptin 50 mg: Day 14, pre-breakfast||-0.08|-2.05|
70853936|NCT01128621|141195977|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.289|||||TWO_SIDED|95.0|-0.71|1.29||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast||1.29|-0.71|
70853937|NCT01128621|141195977|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.257|||||TWO_SIDED|95.0|0.22|2.29||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast||2.29|0.22|
70853938|NCT01128621|141195977|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.669|||||TWO_SIDED|95.0|0.68|2.65||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast||2.65|0.68|
71117422|NCT01559259|141740585|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|13.54|||<|0.001|TWO_SIDED|95.0|10.95|16.13||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||16.13|10.95|<0.001
71117423|NCT01559259|141740585|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|12.04|||<|0.001|TWO_SIDED|95.0|9.45|14.63||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||14.63|9.45|<0.001
71117424|NCT01559259|141740585|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.1||||0.235|TWO_SIDED|95.0|-0.72|2.91||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.91|-0.72|0.235
70853939|NCT01128621|141195977|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.556|||||TWO_SIDED|95.0|-1.65|0.54||||||Placebo vs GSK1292263 75 mg: Day 14, 24 hours||0.54|-1.65|
70853940|NCT01128621|141195977|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.745|||||TWO_SIDED|95.0|-0.4|1.89||||||Placebo vs GSK1292263 300 mg: Day 14, 24 hours||1.89|-0.40|
70853941|NCT01128621|141195977|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.711|||||TWO_SIDED|95.0|-0.36|1.78||||||Placebo vs GSK1292263 600 mg: Day 14, 24 hours||1.78|-0.36|
70853942|NCT01128621|141195977|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.03|||||TWO_SIDED|95.0|-2.15|0.09||||||Placebo vs Sitagliptin 50 mg: Day 14, 24 hours||0.09|-2.15|
70853943|NCT01128621|141195977|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.474|||||TWO_SIDED|95.0|-0.66|1.61||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 14, 24 hours||1.61|-0.66|
70853944|NCT01128621|141195977|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.775|||||TWO_SIDED|95.0|0.6|2.95||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 14, 24 hours||2.95|0.60|
70853945|NCT01128621|141195977|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.741|||||TWO_SIDED|95.0|0.63|2.86||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 14, 24 hours||2.86|0.63|
70853946|NCT01128621|141195978|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.195|||||TWO_SIDED|95.0|-17.17|17.56||||||Placebo vs GSK1292263 75 mg: Day 7, pre-breakfast||17.56|-17.17|
70853947|NCT01128621|141195978|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.863|||||TWO_SIDED|95.0|-34.7|0.98||||||Placebo vs GSK1292263 300 mg: Day 7, pre-breakfast||0.98|-34.70|
70853948|NCT01128621|141195978|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.46|||||TWO_SIDED|95.0|-23.04|12.12||||||Placebo vs GSK1292263 600 mg: Day 7, pre-breakfast||12.12|-23.04|
70853949|NCT01128621|141195978|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.85|||||TWO_SIDED|95.0|-13.89|21.58||||||Placebo vs Sitagliptin 50 mg: Day 7, pre-breakfast||21.58|-13.89|
70853950|NCT01128621|141195978|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.655|||||TWO_SIDED|95.0|-21.7|14.39||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 7, pre-breakfast||14.39|-21.70|
70853951|NCT01128621|141195978|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.712|||||TWO_SIDED|95.0|-39.25|-2.17||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 7, pre-breakfast||-2.17|-39.25|
70853952|NCT01128621|141195978|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.31|||||TWO_SIDED|95.0|-27.63|9.01||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 7, pre-breakfast||9.01|-27.63|
70853953|NCT01128621|141195978|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.649|||||TWO_SIDED|95.0|-19.43|12.14||||||Placebo vs GSK1292263 75 mg: Day 14, pre-breakfast||12.14|-19.43|
70853954|NCT01128621|141195978|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.66|||||TWO_SIDED|95.0|-32.72|-0.6||||||Placebo vs GSK1292263 300 mg: Day 14, pre-breakfast||-0.60|-32.72|
70853955|NCT01128621|141195978|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.251|||||TWO_SIDED|95.0|-38.34|-6.16||||||Placebo vs GSK1292263 600 mg: Day 14, pre-breakfast||-6.16|-38.34|
70853956|NCT01128621|141195978|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.59|||||TWO_SIDED|95.0|-20.69|11.51||||||Placebo vs Sitagliptin 50 mg: Day 14, pre-breakfast||11.51|-20.69|
70853957|NCT01128621|141195978|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.941|||||TWO_SIDED|95.0|-15.4|17.28||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast||17.28|-15.40|
70853958|NCT01128621|141195978|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.07|||||TWO_SIDED|95.0|-28.82|4.68||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast||4.68|-28.82|
70853959|NCT01128621|141195978|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.662|||||TWO_SIDED|95.0|-34.72|-0.6||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast||-0.60|-34.72|
70853960|NCT01128621|141195978|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.101|||||TWO_SIDED|95.0|-44.0|5.8||||||Placebo vs GSK1292263 75 mg: Day 14, 24 hours||5.80|-44.00|
70853961|NCT01128621|141195978|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-27.976|||||TWO_SIDED|95.0|-53.56|-2.39||||||Placebo vs GSK1292263 300 mg: Day 14, 24 hours||-2.39|-53.56|
70853962|NCT01128621|141195978|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.609|||||TWO_SIDED|95.0|-48.82|1.6||||||Placebo vs GSK1292263 600 mg: Day 14, 24 hours||1.60|-48.82|
70853963|NCT01128621|141195978|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.094|||||TWO_SIDED|95.0|-22.34|28.53||||||Placebo vs Sitagliptin 50 mg: Day 14, 24 hours||28.53|-22.34|
71117425|NCT01559259|141740585|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.1||||0.91|TWO_SIDED|95.0|-1.91|1.7||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.70|-1.91|0.910
71117426|NCT01559259|141740585|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.5||||0.105|TWO_SIDED|95.0|-0.32|3.31||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.31|-0.32|0.105
71117427|NCT01559259|141740585|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|16.05|||<|0.001|TWO_SIDED|95.0|12.49|19.61||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||19.61|12.49|<0.001
70853964|NCT01128621|141195978|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.194|||||TWO_SIDED|95.0|-48.07|3.69||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 14, 24 hours||3.69|-48.07|
70853965|NCT01128621|141195978|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-31.07|||||TWO_SIDED|95.0|-57.66|-4.48||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 14, 24 hours||-4.48|-57.66|
71117428|NCT01559259|141740585|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|14.88|||<|0.001|TWO_SIDED|95.0|11.33|18.43||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||18.43|11.33|<0.001
70853966|NCT01128621|141195978|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.703|||||TWO_SIDED|95.0|-52.98|-0.42||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 14, 24 hours||-0.42|-52.98|
71077329|NCT00938587|141664096|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|5.282||0.8866|TWO_SIDED|90.0|-9.52|8.01|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||8.01|-9.52|0.8866
71077330|NCT00938587|141664096|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-6.11|STANDARD_ERROR_OF_MEAN|5.28||0.2499|TWO_SIDED|90.0|-14.88|2.66|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.66|-14.88|0.2499
70853967|NCT01128621|141195981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-1.5|0.5||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-12), Day 7||0.50|-1.50|
71077331|NCT00938587|141664096|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.78|STANDARD_ERROR_OF_MEAN|5.283||0.5995|TWO_SIDED|90.0|-5.99|11.55|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||11.55|-5.99|0.5995
71077332|NCT00938587|141664096|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|5.429||0.9117|TWO_SIDED|90.0|-8.4|9.61|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||9.61|-8.40|0.9117
71077333|NCT00938587|141664096|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.91|STANDARD_ERROR_OF_MEAN|5.381||0.0684|TWO_SIDED|90.0|-18.84|-0.98|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.98|-18.84|0.0684
71077334|NCT00938587|141664096|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-6.49|STANDARD_ERROR_OF_MEAN|5.366||0.2292|TWO_SIDED|90.0|-15.39|2.42|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.42|-15.39|0.2292
71077335|NCT00938587|141664096|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-17.0|STANDARD_ERROR_OF_MEAN|5.308||0.0018|TWO_SIDED|90.0|-25.81|-8.19|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-8.19|-25.81|0.0018
71077336|NCT00938587|141664096|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.09|STANDARD_ERROR_OF_MEAN|5.337||0.1867|TWO_SIDED|90.0|-15.95|1.76|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.76|-15.95|0.1867
71077337|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|2.708||0.9624|TWO_SIDED|90.0|-4.64|4.38|||ANCOVA|||Physical functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using analysis of covariance (ANCOVA) where treatment as fixed effect, baseline as the covariate.||4.38|-4.64|0.9624
71077338|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|2.65||0.9493|TWO_SIDED|90.0|-4.24|4.58|||ANCOVA|||Physical functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.58|-4.24|0.9493
71077339|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.46|STANDARD_ERROR_OF_MEAN|2.738||0.21|TWO_SIDED|90.0|-1.1|8.02|||ANCOVA|||Physical functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.02|-1.10|0.2100
71077340|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.76|STANDARD_ERROR_OF_MEAN|2.651||0.1602|TWO_SIDED|90.0|-0.66|8.18|||ANCOVA|||Physical functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.18|-0.66|0.1602
71077341|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.59|STANDARD_ERROR_OF_MEAN|2.71||0.1892|TWO_SIDED|90.0|-0.92|8.1|||ANCOVA|||Physical functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.10|-0.92|0.1892
71077342|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.74|STANDARD_ERROR_OF_MEAN|2.781||0.7899|TWO_SIDED|90.0|-3.89|5.38|||ANCOVA|||Role physical at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||5.38|-3.89|0.7899
71077343|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.96|STANDARD_ERROR_OF_MEAN|2.719||0.149|TWO_SIDED|90.0|-0.56|8.49|||ANCOVA|||Role physical at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.49|-0.56|0.1490
71077344|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.36|STANDARD_ERROR_OF_MEAN|2.766||0.6238|TWO_SIDED|90.0|-5.97|3.24|||ANCOVA|||Role physical at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||3.24|-5.97|0.6238
71077345|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.86|STANDARD_ERROR_OF_MEAN|2.699||0.4933|TWO_SIDED|90.0|-2.64|6.35|||ANCOVA|||Role physical at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||6.35|-2.64|0.4933
71077346|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.11|STANDARD_ERROR_OF_MEAN|2.739||0.4445|TWO_SIDED|90.0|-6.67|2.46|||ANCOVA|||Role physical at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||2.46|-6.67|0.4445
70853968|NCT01128621|141195981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.513|||||TWO_SIDED|95.0|-0.51|1.54||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-12), Day 7||1.54|-0.51|
70853969|NCT01128621|141195981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.03|||||TWO_SIDED|95.0|0.05|2.01||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-12), Day 7||2.01|0.05|
70853970|NCT01128621|141195981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.955|||||TWO_SIDED|95.0|-1.98|0.07||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||0.07|-1.98|
70853971|NCT01128621|141195981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.454|||||TWO_SIDED|95.0|-0.59|1.5||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||1.50|-0.59|
70853972|NCT01128621|141195981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.468|||||TWO_SIDED|95.0|0.39|2.55||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||2.55|0.39|
71077347|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.51|STANDARD_ERROR_OF_MEAN|2.897||0.2288|TWO_SIDED|90.0|-1.31|8.34|||ANCOVA|||Bodily pain at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.34|-1.31|0.2288
71077348|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.77|STANDARD_ERROR_OF_MEAN|2.844||0.098|TWO_SIDED|90.0|0.03|9.5|||ANCOVA|||Bodily pain at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate||9.50|0.03|0.0980
71077349|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.54|STANDARD_ERROR_OF_MEAN|2.941||0.0637|TWO_SIDED|90.0|0.64|10.43|||ANCOVA|||Bodily pain at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate||10.43|0.64|0.0637
71117429|NCT01559259|141740585|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|16.76|||<|0.001|TWO_SIDED|95.0|13.2|20.32||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||20.32|13.20|<0.001
71117430|NCT01559259|141740585|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|15.23|||<|0.001|TWO_SIDED|95.0|11.68|18.78||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||18.78|11.68|<0.001
71117431|NCT01559259|141740585|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.83||||0.514|TWO_SIDED|95.0|-1.66|3.32||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.32|-1.66|0.514
71117432|NCT01559259|141740585|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.35||||0.783|TWO_SIDED|95.0|-2.82|2.13||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.13|-2.82|0.783
71117433|NCT01559259|141740585|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.53||||0.227|TWO_SIDED|95.0|-0.96|4.02||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.02|-0.96|0.227
71117434|NCT01559259|141740585|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|18.28|||<|0.001|TWO_SIDED|95.0|12.95|23.61||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||23.61|12.95|<0.001
71117435|NCT01559259|141740585|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|17.3|||<|0.001|TWO_SIDED|95.0|11.99|22.61||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||22.61|11.99|<0.001
71117436|NCT01559259|141740585|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|20.45|||<|0.001|TWO_SIDED|95.0|15.13|25.78||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||25.78|15.13|<0.001
70853973|NCT01128621|141195981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.985|||||TWO_SIDED|95.0|0.96|3.01||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||3.01|0.96|
70853974|NCT01128621|141195981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.312|||||TWO_SIDED|95.0|-1.38|0.76||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-12), Day 14||0.76|-1.38|
70853975|NCT01128621|141195981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.394|||||TWO_SIDED|95.0|-0.7|1.49||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-12), Day 14||1.49|-0.70|
71077350|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.79|STANDARD_ERROR_OF_MEAN|2.831||0.019|TWO_SIDED|90.0|2.07|11.5|||ANCOVA|||Bodily pain at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||11.50|2.07|0.0190
71077351|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.02|STANDARD_ERROR_OF_MEAN|2.903||0.4886|TWO_SIDED|90.0|-2.81|6.86|||ANCOVA|||Bodily pain at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||6.86|-2.81|0.4886
71077352|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|1.879||0.9951|TWO_SIDED|90.0|-3.12|3.14|||ANCOVA|||General health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||3.14|-3.12|0.9951
71077353|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.31|STANDARD_ERROR_OF_MEAN|1.818||0.4721|TWO_SIDED|90.0|-1.71|4.34|||ANCOVA|||General health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.34|-1.71|0.4721
71077354|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.77|STANDARD_ERROR_OF_MEAN|1.879||0.6835|TWO_SIDED|90.0|-3.9|2.36|||ANCOVA|||General health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||2.36|-3.90|0.6835
71077355|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.53|STANDARD_ERROR_OF_MEAN|1.818||0.7701|TWO_SIDED|90.0|-2.49|3.56|||ANCOVA|||General health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||3.56|-2.49|0.7701
71077356|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.78|STANDARD_ERROR_OF_MEAN|1.831||0.671|TWO_SIDED|90.0|-3.83|2.27|||ANCOVA|||General health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||2.27|-3.83|0.6710
71117437|NCT01559259|141740585|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|18.92|||<|0.001|TWO_SIDED|95.0|13.61|24.24||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||24.24|13.61|<0.001
71117438|NCT01559259|141740585|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.64||||0.736|TWO_SIDED|95.0|-4.37|3.09||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.09|-4.37|0.736
71117439|NCT01559259|141740585|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.62||||0.39|TWO_SIDED|95.0|-5.32|2.08||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.08|-5.32|0.390
71117440|NCT01559259|141740585|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.53||||0.42|TWO_SIDED|95.0|-2.19|5.26||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||5.26|-2.19|0.420
71117441|NCT01559259|141740586|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.5|||<|0.001|TWO_SIDED|95.0|5.25|7.76||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||7.76|5.25|<0.001
71117442|NCT01559259|141740586|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.87|||<|0.001|TWO_SIDED|95.0|4.62|7.11||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||7.11|4.62|<0.001
71117443|NCT01559259|141740586|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|6.63|||<|0.001|TWO_SIDED|95.0|5.38|7.88||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||7.88|5.38|<0.001
71117444|NCT01559259|141740586|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.48|||<|0.001|TWO_SIDED|95.0|4.23|6.73||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||6.73|4.23|<0.001
71077357|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.02|STANDARD_ERROR_OF_MEAN|2.827||0.2886|TWO_SIDED|90.0|-1.69|7.73|||ANCOVA|||Vitality at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||7.73|-1.69|0.2886
71077358|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.22|STANDARD_ERROR_OF_MEAN|2.784||0.134|TWO_SIDED|90.0|-0.42|8.86|||ANCOVA|||Vitality at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.86|-0.42|0.1340
70941228|NCT00449033|141382511|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.401||95.0|0.83|1.16|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.||Sample size based on the primary efficacy endpoint of OS in the ITT (non-squamous) population. Clinically meaningful improvement defined as 30% increase in median OS (that is, a hazard ratio of 0.76923, Sorafenib+GC over Placebo+GC). With one-sided alpha of 0.025, power of 86% and a randomization ratio of 1:1 between Sorafenib+GC and Placebo+GC, and one formal final analysis of OS performed, a total of 544 events (deaths) were required.||1.16|0.83|0.401
70941229|NCT00449033|141382512|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.563||95.0|0.87|1.18|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.025 stratified by the same factors as randomization plus histology.||||1.18|0.87|0.563
70941230|NCT00449033|141382514|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.008||95.0|0.71|0.97|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.||||0.97|0.71|0.008
71077359|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.24|STANDARD_ERROR_OF_MEAN|2.83||0.2563|TWO_SIDED|90.0|-1.48|7.95|||ANCOVA|||Vitality at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||7.95|-1.48|0.2563
70941231|NCT00449033|141382515|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0004||95.0|0.6|0.88|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.||||0.88|0.60|0.0004
70941232|NCT00449033|141382516|SUPERIORITY_OR_OTHER||Difference in Tumour Response (CR+PR)|-1.92||||0.2733||95.0|-8.19|4.34|||Cochran-Mantel-Haenszel|Two treatment groups compared using a CMH test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.||||4.34|-8.19|0.2733
70941233|NCT00449033|141382517|SUPERIORITY_OR_OTHER||Difference in Disease Control|0.97||||0.3902||95.0|-5.87|7.81|||Cochran-Mantel-Haenszel|Two treatment groups compared using a CMH test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.||||7.81|-5.87|0.3902
71077360|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.43|STANDARD_ERROR_OF_MEAN|2.771||0.1138|TWO_SIDED|90.0|-0.18|9.05|||ANCOVA|||Vitality at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||9.05|-0.18|0.1138
71077361|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.22|STANDARD_ERROR_OF_MEAN|2.793||0.9386|TWO_SIDED|90.0|-4.44|4.87|||ANCOVA|||Vitality at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.87|-4.44|0.9386
71077362|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.4|STANDARD_ERROR_OF_MEAN|2.701||0.8814|TWO_SIDED|90.0|-4.09|4.9|||ANCOVA|||Social functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.90|-4.09|0.8814
71077363|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.98|STANDARD_ERROR_OF_MEAN|2.64||0.1363|TWO_SIDED|90.0|-0.42|8.37|||ANCOVA|||Social functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.37|-0.42|0.1363
71117445|NCT01559259|141740586|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.03||||0.022|TWO_SIDED|95.0|0.15|1.9||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.90|0.15|0.022
71117446|NCT01559259|141740586|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.39||||0.38|TWO_SIDED|95.0|-0.48|1.26||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.26|-0.48|0.380
70853976|NCT01128621|141195981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.875|||||TWO_SIDED|95.0|-0.18|1.93||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-12), Day 14||1.93|-0.18|
70941234|NCT01770509|141382541|SUPERIORITY_OR_OTHER|||||||0.652|||||||ANOVA|General Linear Model ANOVA with repeated measures||||||0.652
70941235|NCT01770509|141382542|SUPERIORITY_OR_OTHER|||||||0.645|||||||ANOVA|General Linear Model ANOVA with repeated measures||||||0.645
70941236|NCT01370564|141382546|OTHER|There was no specific hypothesis tested. The method of Rao and Scott for clustered binary data was used to construct a point estimate and 95% confidence interval for the number of days during the follow-up period across all subjects in which the patient instruction set was based on the subject's pressure state as measured by the Chronicle IHM/ICD system.|Rao-Scott estimator for clustered data|72.0|||||TWO_SIDED|95.0|65.0|78.0||||||||78|65|
70941237|NCT02181400|141382553|OTHER|||||||0.04|||||||ANCOVA|||||||0.04
70941238|NCT02181400|141382554|OTHER|||||||0.04|||||||ANCOVA|||||||0.04
71077364|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.73|STANDARD_ERROR_OF_MEAN|2.682||0.7864|TWO_SIDED|90.0|-3.74|5.2|||ANCOVA|||Social functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||5.20|-3.74|0.7864
71077365|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.3|STANDARD_ERROR_OF_MEAN|2.619||0.1048|TWO_SIDED|90.0|-0.06|8.66|||ANCOVA|||Social functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.66|-0.06|0.1048
70941239|NCT02181400|141382555|OTHER|||||||0.12|||||||ANCOVA|||||||0.12
70853977|NCT01128621|141195981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.854|||||TWO_SIDED|95.0|-1.95|0.25||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||0.25|-1.95|
70941240|NCT02181400|141382556|OTHER|||||||0.32|||||||ANCOVA|||||||0.32
70941241|NCT02181400|141382557|OTHER|||||||0.02|||||||ANCOVA|||||||0.02
70941242|NCT02181400|141382558|OTHER|||||||0.49|||||||ANCOVA|||||||0.49
70941243|NCT01245699|141382570|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71077366|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.33|STANDARD_ERROR_OF_MEAN|2.643||0.9024|TWO_SIDED|90.0|-4.08|4.73|||ANCOVA|||Social functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.73|-4.08|0.9024
71077367|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.62|STANDARD_ERROR_OF_MEAN|3.819||0.4954|TWO_SIDED|90.0|-3.74|8.98|||ANCOVA|||Role emotional at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.98|-3.74|0.4954
71077368|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.14|STANDARD_ERROR_OF_MEAN|3.735||0.1729|TWO_SIDED|90.0|-1.08|11.36|||ANCOVA|||Role emotional at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||11.36|-1.08|0.1729
71077369|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.21|STANDARD_ERROR_OF_MEAN|3.82||0.565|TWO_SIDED|90.0|-4.15|8.57|||ANCOVA|||Role emotional at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.57|-4.15|0.5650
71117447|NCT01559259|141740586|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.15||||0.01|TWO_SIDED|95.0|0.28|2.03||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.03|0.28|0.010
71117448|NCT01559259|141740586|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|21.52|||<|0.001|TWO_SIDED|95.0|17.17|25.87||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||25.87|17.17|<0.001
71077370|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.73|STANDARD_ERROR_OF_MEAN|3.73||0.2087|TWO_SIDED|90.0|-1.48|10.94|||ANCOVA|||Role emotional at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||10.94|-1.48|0.2087
71077371|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|3.771||0.9139|TWO_SIDED|90.0|-6.69|5.87|||ANCOVA|||Role emotional at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||5.87|-6.69|0.9139
71117449|NCT01559259|141740586|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|19.62|||<|0.001|TWO_SIDED|95.0|15.29|23.95||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||23.95|15.29|<0.001
70853978|NCT01128621|141195981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.542|||||TWO_SIDED|95.0|-0.58|1.66||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||1.66|-0.58|
70853979|NCT01128621|141195981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.248|||||TWO_SIDED|95.0|0.09|2.4||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||2.40|0.09|
70941244|NCT01245699|141382571|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
70941245|NCT01245699|141382572|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||||||0.1
70941246|NCT01245699|141382573|SUPERIORITY|||||||0.65|||||||Kruskal-Wallis|||||||0.65
70941247|NCT00390806|141382575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.1862|TWO_SIDED|95.0|0.73|1.07||p-value from a stratified log-rank test is adjusted for Recursive Partitioning Analysis (RPA) class and the number of brain lesions at Screening.|Log Rank||The hazard ratio is estimated using a Pike estimator. The hazard ratio from a stratified log-rank test is adjusted for RPA class and the number of brain lesions at Screening.|||1.07|0.73|0.1862
70941248|NCT04150250|141382615|SUPERIORITY||Difference in Median|-7.1||||0.2254|TWO_SIDED|95.0|-30.9|28.6||The threshold to define success on the primary efficacy endpoint at the final analysis is one-sided alpha = 0.0238.|Van Elteren test|Stratified by blood type group (O vs. Non-O)||||28.6|-30.9|0.2254
70941249|NCT04150250|141382616|SUPERIORITY||Difference in Median|-3.8||||0.2751|TWO_SIDED|95.0|-26.3|27.4|||Van Elteren test|Stratified by blood type group||||27.4|-26.3|0.2751
70941250|NCT04150250|141382618|SUPERIORITY||Difference|-11.3||||0.5145|TWO_SIDED|95.0|-44.1|21.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, stratified by blood type group.||||21.6|-44.1|0.5145
70941251|NCT04150250|141382619|SUPERIORITY||Difference|-6.3||||0.2636|TWO_SIDED|95.0|-18.1|5.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, stratified by blood type group.||||5.6|-18.1|0.2636
70941252|NCT04150250|141382620|SUPERIORITY||Difference in Median|1.1||||0.5992|TWO_SIDED|95.0|-4.5|7.8|||Van Elteren test|Stratified by blood type group||||7.8|-4.5|0.5992
70941253|NCT04150250|141382622|SUPERIORITY|||||||0.6527|||||||Log Rank|Stratified by blood type group||||||0.6527
70941254|NCT04150250|141382623|SUPERIORITY||Difference in Median|1.5||||0.5377|TWO_SIDED|95.0|-7.0|5.5|||Van Elteren test|Stratified by blood type group||||5.5|-7.0|0.5377
70941255|NCT04150250|141382624|SUPERIORITY||Difference|1.3||||0.8705|TWO_SIDED|95.0|-14.0|16.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, stratified by blood type group.||||16.5|-14.0|0.8705
70941256|NCT04150250|141382625|SUPERIORITY||Difference|-18.8||||0.1404|TWO_SIDED|95.0|-41.1|3.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, stratified by blood type group||||3.6|-41.1|0.1404
70941257|NCT00748098|141382660|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|-26.0|||<|0.0001|TWO_SIDED|95.0|-35.64|-16.36|||ANCOVA|Estimates were obtained using an ANCOVA model with period, group center, and treatment as fixed effects and participant as a random effect.||||-16.36|-35.64|<0.0001
70941258|NCT00748098|141382661|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|-3.07||||0.002|TWO_SIDED|95.0|-5.04|-1.1|||ANCOVA|Estimates were obtained using an ANCOVA model with period, group center, and treatment as fixed effects and participant as a random effect.||||-1.10|-5.04|0.002
70941259|NCT01232569|141382702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.5|||<|0.001|TWO_SIDED|95.0|22.0|37.0|||Cochran-Mantel-Haenszel|Analysis adjusted for the randomization stratification factors applied at Baseline (region and weight category).||||37.0|22.0|<0.001
70941260|NCT04044352|141382720|OTHER|Likelihood ratio test was the statistical test.|Odds Ratio (OR)|0.81||||0.126|TWO_SIDED|95.0|0.62|1.06|||Wald Chi-Square||A two-fold increase in HAI pre-challenge titer (i.e. one unit increase in log-2 titer) corresponds to a 19% decrease in the odds of developing MMID during the study challenge period (Day 2 through Day 8).|Pre-challenge (baseline) HAI geometric mean titer was log-2 transformed and treated as a continuous variable in the model.||1.06|0.62|0.126
70941261|NCT00396097|141382768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.033||0.5762|ONE_SIDED|97.5|-0.071||||ANCOVA|||The null hypothesis was that the individualized treatment arm was not superior to the standard treatment arm; alternative hypothesis that the individualized treatment arm was superior to the standard treatment arm with respect to the mean 24-month AOTD. Using a 2:1 randomization, a two sided sample t-test comparing the root AOTD between the 2 treatment arms with 80% power at a 5% level required 260 subjects. Assuming a 20% attrition rate, approximately 312 subjects were needed for this study.|||-0.071|0.5762
70941262|NCT00396097|141382769|SUPERIORITY_OR_OTHER|||||||0.627|TWO_SIDED||||||ANOVA (Levene's Test)|||||||0.627
70941263|NCT00396097|141382770|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.033||||0.8016|TWO_SIDED|95.0|0.802|1.33|||Regression, Cox|||||1.330|0.802|0.8016
70941264|NCT00396097|141382771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.822|STANDARD_ERROR_OF_MEAN|2.25||0.0101|TWO_SIDED|95.0|1.395|10.249|||ANCOVA|||||10.249|1.395|0.0101
70941265|NCT00396097|141382771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.281|STANDARD_ERROR_OF_MEAN|2.471||0.0002|TWO_SIDED|95.0|4.417|14.145|||ANCOVA|||||14.145|4.417|0.0002
71077372|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.51|STANDARD_ERROR_OF_MEAN|3.371||0.6559|TWO_SIDED|90.0|-4.11|7.12|||ANCOVA|||Mental health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||7.12|-4.11|0.6559
71117450|NCT01559259|141740586|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|22.24|||<|0.001|TWO_SIDED|95.0|17.89|26.59||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||26.59|17.89|<0.001
70941266|NCT00396097|141382771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.204|STANDARD_ERROR_OF_MEAN|2.495||0.2001|TWO_SIDED|95.0|-1.707|8.114|||ANCOVA|||||8.114|-1.707|0.2001
70941267|NCT00396097|141382772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.899|STANDARD_ERROR_OF_MEAN|3.414|<|0.0001|TWO_SIDED|95.0|30.181|43.618|||ANCOVA|||||43.618|30.181|<0.0001
71077373|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.15|STANDARD_ERROR_OF_MEAN|3.315||0.7304|TWO_SIDED|90.0|-4.37|6.67|||ANCOVA|||Mental health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||6.67|-4.37|0.7304
71077374|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.64|STANDARD_ERROR_OF_MEAN|3.369||0.1729|TWO_SIDED|90.0|-0.98|10.25|||ANCOVA|||Mental health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||10.25|-0.98|0.1729
71077375|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.27|STANDARD_ERROR_OF_MEAN|3.335||0.2038|TWO_SIDED|90.0|-1.28|9.83|||ANCOVA|||Mental health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||9.83|-1.28|0.2038
71077376|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.13|STANDARD_ERROR_OF_MEAN|3.328||0.3503|TWO_SIDED|90.0|-2.41|8.67|||ANCOVA|||Mental health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.67|-2.41|0.3503
71077377|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.29|STANDARD_ERROR_OF_MEAN|2.01||0.8875|TWO_SIDED|90.0|-3.06|3.63|||ANCOVA|||Physical component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||3.63|-3.06|0.8875
71077378|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.97|STANDARD_ERROR_OF_MEAN|1.971||0.3203|TWO_SIDED|90.0|-1.31|5.25|||ANCOVA|||Physical component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||5.25|-1.31|0.3203
71077379|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.31|STANDARD_ERROR_OF_MEAN|2.046||0.5232|TWO_SIDED|90.0|-2.09|4.72|||ANCOVA|||Physical component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.72|-2.09|0.5232
71077380|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.0|STANDARD_ERROR_OF_MEAN|1.971||0.1324|TWO_SIDED|90.0|-0.28|6.28|||ANCOVA|||Physical component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||6.28|-0.28|0.1324
71077381|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.03|STANDARD_ERROR_OF_MEAN|2.024||0.6134|TWO_SIDED|90.0|-2.34|4.4|||ANCOVA|||Physical component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.40|-2.34|0.6134
71077382|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.26|STANDARD_ERROR_OF_MEAN|3.387||0.5059|TWO_SIDED|90.0|-3.38|7.91|||ANCOVA|||Mental component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||7.91|-3.38|0.5059
71077383|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.44|STANDARD_ERROR_OF_MEAN|3.329||0.3042|TWO_SIDED|90.0|-2.1|8.99|||ANCOVA|||Mental component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.99|-2.10|0.3042
71077384|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.18|STANDARD_ERROR_OF_MEAN|3.39||0.3519|TWO_SIDED|90.0|-2.47|8.82|||ANCOVA|||Mental component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.82|-2.47|0.3519
71077385|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.36|STANDARD_ERROR_OF_MEAN|3.342||0.1966|TWO_SIDED|90.0|-1.21|9.92|||ANCOVA|||Mental component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||9.92|-1.21|0.1966
70853980|NCT01128621|141195981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.729|||||TWO_SIDED|95.0|0.63|2.83||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||2.83|0.63|
70941268|NCT00396097|141382772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|48.517|STANDARD_ERROR_OF_MEAN|3.284|<|0.0001|TWO_SIDED|95.0|42.054|54.98|||ANCOVA|||||54.980|42.054|<.0001
70941269|NCT00396097|141382772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.443|STANDARD_ERROR_OF_MEAN|3.306|<|0.0001|TWO_SIDED|95.0|27.936|40.951|||ANCOVA|||||40.951|27.936|<.0001
70941270|NCT00396097|141382773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.081||0.2618|TWO_SIDED|95.0|-0.068|0.249|||ANCOVA|||||0.249|-0.068|0.2618
70941271|NCT00396097|141382773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.013|STANDARD_ERROR_OF_MEAN|0.094||0.8926|TWO_SIDED|95.0|-0.172|0.198|||ANCOVA|||||0.198|-0.172|0.8926
71077386|NCT00938587|141664097|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.91|STANDARD_ERROR_OF_MEAN|3.345||0.786|TWO_SIDED|90.0|-4.66|6.48|||ANCOVA|||Mental component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||6.48|-4.66|0.7860
71077387|NCT00938587|141664098|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.286||0.109|TWO_SIDED|90.0|-0.93|0.01|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.01|-0.93|0.1090
71077388|NCT00938587|141664098|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.91|STANDARD_ERROR_OF_MEAN|0.282||0.0014|TWO_SIDED|90.0|-1.38|-0.45|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.45|-1.38|0.0014
71077389|NCT00938587|141664098|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.284||0.0506|TWO_SIDED|90.0|-1.03|-0.09|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.09|-1.03|0.0506
71077390|NCT00938587|141664098|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.01|STANDARD_ERROR_OF_MEAN|0.28||0.0004|TWO_SIDED|90.0|-1.48|-0.55|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.55|-1.48|0.0004
71077391|NCT00938587|141664098|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.281||0.7272|TWO_SIDED|90.0|-0.56|0.37|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.37|-0.56|0.7272
71117451|NCT01559259|141740586|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|19.69|||<|0.001|TWO_SIDED|95.0|15.35|24.02||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||24.02|15.35|<0.001
71117452|NCT01559259|141740586|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.83||||0.237|TWO_SIDED|95.0|-1.21|4.88||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.88|-1.21|0.237
71117453|NCT01559259|141740586|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.07||||0.965|TWO_SIDED|95.0|-3.09|2.95||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.95|-3.09|0.965
71117454|NCT01559259|141740586|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.56||||0.099|TWO_SIDED|95.0|-0.48|5.6||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||5.60|-0.48|0.099
71117455|NCT01559259|141740586|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|29.93|||<|0.001|TWO_SIDED|95.0|21.14|38.73||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||38.73|21.14|<0.001
71117456|NCT01559259|141740586|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|28.24|||<|0.001|TWO_SIDED|95.0|19.48|37.0||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||37.00|19.48|<0.001
71117457|NCT01559259|141740586|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|33.1|||<|0.001|TWO_SIDED|95.0|24.31|41.89||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||41.89|24.31|<0.001
71117458|NCT01559259|141740586|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|30.64|||<|0.001|TWO_SIDED|95.0|21.87|39.41||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||39.41|21.87|<0.001
71077392|NCT00938587|141664098|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.296||0.0604|TWO_SIDED|90.0|-1.05|-0.07|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.07|-1.05|0.0604
71077393|NCT00938587|141664098|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.06|STANDARD_ERROR_OF_MEAN|0.285||0.0003|TWO_SIDED|90.0|-1.53|-0.59|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.59|-1.53|0.0003
71077394|NCT00938587|141664098|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.291||0.0377|TWO_SIDED|90.0|-1.09|-0.13|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.13|-1.09|0.0377
71077395|NCT00938587|141664098|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.11|STANDARD_ERROR_OF_MEAN|0.28||0.0001|TWO_SIDED|90.0|-1.57|-0.65|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.65|-1.57|0.0001
71077396|NCT00938587|141664098|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.284||0.8612|TWO_SIDED|90.0|-0.52|0.42|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.42|-0.52|0.8612
70853981|NCT01128621|141195981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.148|||||TWO_SIDED|95.0|-1.21|0.91||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-24), Day 14||0.91|-1.21|
70853982|NCT01128621|141195981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.737|||||TWO_SIDED|95.0|-0.34|1.81||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-24), Day 14||1.81|-0.34|
70853983|NCT01128621|141195981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.245|||||TWO_SIDED|95.0|0.21|2.28||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-24), Day 14||2.28|0.21|
70853984|NCT01128621|141195981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.623|||||TWO_SIDED|95.0|-1.71|0.46||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||0.46|-1.71|
70853985|NCT01128621|141195981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.475|||||TWO_SIDED|95.0|-0.62|1.57||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||1.57|-0.62|
70853986|NCT01128621|141195981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.36|||||TWO_SIDED|95.0|0.23|2.49||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||2.49|0.23|
70853987|NCT01128621|141195981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.869|||||TWO_SIDED|95.0|0.79|2.95||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||2.95|0.79|
70853988|NCT01128621|141195982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.619|||||TWO_SIDED|95.0|-59.25|2.01||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-12), Day 7||2.01|-59.25|
70853989|NCT01128621|141195982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-47.898|||||TWO_SIDED|95.0|-79.23|-16.56||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-12), Day 7||-16.56|-79.23|
71117459|NCT01559259|141740586|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.71||||0.821|TWO_SIDED|95.0|-6.86|5.44||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||5.44|-6.86|0.821
71117460|NCT01559259|141740586|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-2.4||||0.44|TWO_SIDED|95.0|-8.51|3.71||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.71|-8.51|0.440
71117461|NCT01559259|141740586|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.46||||0.432|TWO_SIDED|95.0|-3.69|8.61||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||8.61|-3.69|0.432
71117462|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.08||||0.571|TWO_SIDED|95.0|-1.04|3.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and its associated 95% CI was calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions and the corresponding standard error.||3.20|-1.04|0.571
71117463|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|0.98||||0.593|TWO_SIDED|95.0|-0.94|2.9||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.90|-0.94|0.593
70853990|NCT01128621|141195982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.665|||||TWO_SIDED|95.0|-55.53|6.2||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-12), Day 7||6.20|-55.53|
70853991|NCT01128621|141195982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.438|||||TWO_SIDED|95.0|-36.76|25.89||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||25.89|-36.76|
70853992|NCT01128621|141195982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.181|||||TWO_SIDED|95.0|-55.0|8.63||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||8.63|-55.00|
70853993|NCT01128621|141195982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-42.46|||||TWO_SIDED|95.0|-75.18|-9.74||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||-9.74|-75.18|
70853994|NCT01128621|141195982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.227|||||TWO_SIDED|95.0|-51.83|13.37||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||13.37|-51.83|
70853995|NCT01128621|141195982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-18.435|||||TWO_SIDED|95.0|-49.15|12.28||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-12), Day 14||12.28|-49.15|
70853996|NCT01128621|141195982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-58.658|||||TWO_SIDED|95.0|-90.08|-27.24||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-12), Day 14||-27.24|-90.08|
70853997|NCT01128621|141195982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-37.006|||||TWO_SIDED|95.0|-67.96|-6.05||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-12), Day 14||-6.05|-67.96|
70853998|NCT01128621|141195982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.896|||||TWO_SIDED|95.0|-41.31|21.52||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||21.52|-41.31|
70853999|NCT01128621|141195982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.539|||||TWO_SIDED|95.0|-40.44|23.36||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||23.36|-40.44|
70854000|NCT01128621|141195982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-48.762|||||TWO_SIDED|95.0|-81.58|-15.95||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||-15.95|-81.58|
70854001|NCT01128621|141195982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-27.11|||||TWO_SIDED|95.0|-59.8|5.58||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||5.58|-59.80|
70854002|NCT01128621|141195982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.359|||||TWO_SIDED|95.0|-48.95|8.23||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-24), Day 14||8.23|-48.95|
70854003|NCT01128621|141195982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-53.712|||||TWO_SIDED|95.0|-82.92|-24.5||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-24), Day 14||-24.50|-82.92|
70854004|NCT01128621|141195982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-37.552|||||TWO_SIDED|95.0|-66.24|-8.86||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-24), Day 14||-8.86|-66.24|
71077397|NCT00938587|141664098|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.44|STANDARD_ERROR_OF_MEAN|0.292||0.133|TWO_SIDED|90.0|-0.04|0.93|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.93|-0.04|0.1330
71077398|NCT00938587|141664098|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.285||0.8542|TWO_SIDED|90.0|-0.52|0.42|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.42|-0.52|0.8542
71077399|NCT00938587|141664098|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.288||0.2339|TWO_SIDED|90.0|-0.13|0.82|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.82|-0.13|0.2339
71077400|NCT00938587|141664098|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.28||0.5927|TWO_SIDED|90.0|-0.61|0.31|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.31|-0.61|0.5927
71077401|NCT00938587|141664098|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.284||0.7304|TWO_SIDED|90.0|-0.57|0.37|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.37|-0.57|0.7304
71077402|NCT00938587|141664099|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.29||0.0956|TWO_SIDED|90.0|-0.97|-0.01|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.01|-0.97|0.0956
71077403|NCT00938587|141664099|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.93|STANDARD_ERROR_OF_MEAN|0.286||0.0016|TWO_SIDED|90.0|-1.4|-0.45|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.45|-1.40|0.0016
71077404|NCT00938587|141664099|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.65|STANDARD_ERROR_OF_MEAN|0.287||0.0258|TWO_SIDED|90.0|-1.13|-0.17|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.17|-1.13|0.0258
71077405|NCT00938587|141664099|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.09|STANDARD_ERROR_OF_MEAN|0.283||0.0002|TWO_SIDED|90.0|-1.56|-0.62|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.62|-1.56|0.0002
71077406|NCT00938587|141664099|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.284||0.5692||90.0|-0.63|0.31|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.31|-0.63|0.5692
71077407|NCT00938587|141664100|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|14.29||||0.146|TWO_SIDED|90.0|-8.65|35.98|||Barnard exact test|||Day 7||35.98|-8.65|0.1460
70854005|NCT01128621|141195982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.963|||||TWO_SIDED|95.0|-37.2|21.27||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||21.27|-37.20|
71117464|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.65||||0.282|TWO_SIDED|95.0|-0.39|7.68||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||7.68|-0.39|0.282
71117465|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.16||||0.552|TWO_SIDED|95.0|-1.11|3.42||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.42|-1.11|0.552
70854006|NCT01128621|141195982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.397|||||TWO_SIDED|95.0|-42.1|17.3||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||17.30|-42.10|
70854007|NCT01128621|141195982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-45.749|||||TWO_SIDED|95.0|-76.2|-15.3||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||-15.30|-76.20|
71077408|NCT00938587|141664100|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|38.1||||0.0052|TWO_SIDED|90.0|12.25|59.46|||Barnard exact test|||Day 7||59.46|12.25|0.0052
71077409|NCT00938587|141664100|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.3||||0.5094|TWO_SIDED|90.0|-22.0|24.66|||Barnard exact test|||Day 7||24.66|-22.00|0.5094
71077410|NCT00938587|141664100|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|25.11||||0.0551|TWO_SIDED|90.0|-0.69|48.34|||Barnard exact test|||Day 7||48.34|-0.69|0.0551
71077411|NCT00938587|141664100|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-12.99||||0.9999|TWO_SIDED|90.0|-34.09|8.78|||Barnard exact test|||Day 7||8.78|-34.09|0.9999
71077412|NCT00938587|141664100|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|10.56||||0.3027|TWO_SIDED|90.0|-17.18|37.67|||Barnard-Exact test|||Day 14||37.67|-17.18|0.3027
71077413|NCT00938587|141664100|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|21.67||||0.1074|TWO_SIDED|90.0|-6.24|46.16|||Barnard-Exact test|||Day 14||46.16|-6.24|0.1074
71077414|NCT00938587|141664100|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|17.46||||0.234|TWO_SIDED|90.0|-10.08|43.7|||Barnard-Exact test|||Day 14||43.70|-10.08|0.2340
71077415|NCT00938587|141664100|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|28.57||||0.0442|TWO_SIDED|90.0|0.91|53.07|||Barnard-Exact test|||Day 14||53.07|0.91|0.0442
71077416|NCT00938587|141664100|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|6.9||||0.3813|TWO_SIDED|90.0|-19.82|32.92|||Barnard-Exact test|||Day 14||32.92|-19.82|0.3813
71117466|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-0.01||||0.994|TWO_SIDED|95.0|-3.13|3.11||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.11|-3.13|0.994
71117467|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-0.23||||0.879|TWO_SIDED|95.0|-3.26|2.8||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.80|-3.26|0.879
70854008|NCT01128621|141195982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.59|||||TWO_SIDED|95.0|-59.82|0.64||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||0.64|-59.82|
70941272|NCT00396097|141382773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.095||0.9566|TWO_SIDED|95.0|-0.192|0.181|||ANCOVA|||||0.181|-0.192|0.9566
70941273|NCT04086576|141382779|SUPERIORITY||||||<|0.0001||||||Yes, used Tukey Kramer pairwise comparisons to adjust for multiple comparisons|ANOVA|ANOVA in repeated measures||Each breathalyzer is compared to the percentage of alcohol in the blood during the time of blood draw (90 minutes).||||<.0001
71077417|NCT00938587|141664101|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|9.52||||0.1017|TWO_SIDED|90.0|-3.9|27.09|||Barnard exact test|||Day 7||27.09|-3.90|0.1017
71077418|NCT00938587|141664101|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|19.05||||0.0218|TWO_SIDED|90.0|4.49|38.44|||Barnard exact test|||Day 7||38.44|4.49|0.0218
71077419|NCT00938587|141664101|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|9.52||||0.1082|TWO_SIDED|90.0|-3.71|27.06|||Barnard exact test|||Day 7||27.06|-3.71|0.1082
71077420|NCT00938587|141664101|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|19.05||||0.0166|TWO_SIDED|90.0|4.81|38.44|||Barnard exact test|||Day 7||38.44|4.81|0.0166
71077421|NCT00938587|141664101|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|2.22||||0.4776|TWO_SIDED|90.0|-21.61|25.87|||Barnard exact test|||Day 14||25.87|-21.61|0.4776
71077422|NCT00938587|141664101|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|27.62||||0.0347|TWO_SIDED|90.0|2.53|50.78|||Barnard exact test|||Day 14||50.78|2.53|0.0347
71077423|NCT00938587|141664101|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|7.94||||0.3343|TWO_SIDED|90.0|-13.71|31.59|||Barnard exact test|||Day 14||31.59|-13.71|0.3343
71077424|NCT00938587|141664101|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|33.33||||0.0117|TWO_SIDED|90.0|8.35|55.0|||Barnard exact test|||Day 14||55.00|8.35|0.0117
71077425|NCT00938587|141664101|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|5.71||||0.372|TWO_SIDED|90.0|-15.86|27.04|||Barnard exact test|||Day 14||27.04|-15.86|0.3720
71077426|NCT00938587|141664102|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.76||||0.263|TWO_SIDED|90.0|-8.61|20.67|||Barnard exact test|||Day 7||20.67|-8.61|0.2630
71077427|NCT00938587|141664102|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.76||||0.263|TWO_SIDED|90.0|-8.61|20.67|||Barnard exact test|||Day 7||20.67|-8.61|0.2630
71077428|NCT00938587|141664102|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.76||||0.2539|TWO_SIDED|90.0|-7.51|20.67|||Barnard exact test|||Day 7||20.67|-7.51|0.2539
71077429|NCT00938587|141664102|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.76||||0.2539|TWO_SIDED|90.0|-7.51|20.67|||Barnard exact test|||Day 7||20.67|-7.51|0.2539
71077430|NCT00938587|141664102|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|14.29||||0.0477|TWO_SIDED|90.0|0.23|32.92|||Barnard exact test|||Day 14||32.92|0.23|0.0477
71077431|NCT00938587|141664102|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|14.29||||0.0442|TWO_SIDED|90.0|0.65|32.92|||Barnard exact test|||Day 14||32.92|0.65|0.0442
71077432|NCT00938587|141664105|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.33||0.5403|TWO_SIDED|90.0|-0.34|0.75|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.75|-0.34|0.5403
71077433|NCT00938587|141664105|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.33||0.8374|TWO_SIDED|90.0|-0.61|0.48|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.48|-0.61|0.8374
71077434|NCT00938587|141664105|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.329||0.4305|TWO_SIDED|90.0|-0.28|0.8|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.80|-0.28|0.4305
71077435|NCT00938587|141664105|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.325||0.9733|TWO_SIDED|90.0|-0.55|0.53|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.53|-0.55|0.9733
71077436|NCT00938587|141664105|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.325||0.8613|TWO_SIDED|90.0|-0.48|0.6|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.60|-0.48|0.8613
71077437|NCT00938587|141664105|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.22|STANDARD_ERROR_OF_MEAN|0.341||0.5245|TWO_SIDED|90.0|-0.35|0.78|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.78|-0.35|0.5245
71077438|NCT00938587|141664105|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.334||0.8917|TWO_SIDED|90.0|-0.6|0.51|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.51|-0.60|0.8917
71077439|NCT00938587|141664105|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.47|STANDARD_ERROR_OF_MEAN|0.339||0.1695|TWO_SIDED|90.0|-0.09|1.03|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.03|-0.09|0.1695
71077440|NCT00938587|141664105|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.329||0.5339|TWO_SIDED|90.0|-0.34|0.75|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.75|-0.34|0.5339
71077441|NCT00938587|141664105|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.25|STANDARD_ERROR_OF_MEAN|0.332||0.452|TWO_SIDED|90.0|-0.3|0.8|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.80|-0.30|0.4520
71077442|NCT00002525|141664124|SUPERIORITY_OR_OTHER_LEGACY|||||||0.178||||||one-sided log-rank test p value|Log Rank|||||||0.178
71077443|NCT00002525|141664125|SUPERIORITY_OR_OTHER_LEGACY|||||||0.847||||||two-sided log rank test|Log Rank|||||||0.847
71077444|NCT03304184|141664128|EQUIVALENCE|In this analysis, the null hypothesis was that there was no significant difference in global base changes scores between the two treatment groups (Photac and Biodentine)|Mean Difference (Final Values)|3.0||||0.0001|TWO_SIDED|95.0|||||ANOVA||The estimation values were from an average of all values in each arm.|Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.||||.0001
71077445|NCT03304184|141664128|EQUIVALENCE|In this analysis, the null hypothesis was that there was no significant difference in global base changes scores between the two treatment groups (Photac and Biodentine) over timepoints|Mean Difference (Final Values)|3.0||||0.0005|TWO_SIDED|95.0|||||ANOVA||The estimation values were from an average of all values in each arm.|Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.||||.0005
70854009|NCT03595618|141195984|SUPERIORITY||Adjusted mean difference|0.04514|STANDARD_ERROR_OF_MEAN|0.02465||0.165|TWO_SIDED|95.0|-0.00317|0.09345||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% confidence interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose minus placebo using mixed-effects model for repeated measures (MMRM) including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value||0.09345|-0.00317|0.165
70941274|NCT00475735|141382854|SUPERIORITY_OR_OTHER|||||||0.341||95.0||||Since this is a proof of concept study with one primary hypothesis (AISRS total score for MK-0249 vs. placebo), there is no multiplicity adjustment.|Mixed Models Analysis|The terms were tobacco use, prior stimulant use, time, site, period, sequence, treatment, period-by-time, sequence-by-time, and treatment-by-time.||||||0.341
71117468|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.33||||0.28|TWO_SIDED|95.0|-1.98|6.64||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||6.64|-1.98|0.280
71117469|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|33.67|||<|0.001|TWO_SIDED|95.0|24.54|42.81||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||42.81|24.54|<0.001
71117470|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|23.34||||0.003|TWO_SIDED|95.0|14.93|31.75||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||31.75|14.93|0.003
71117471|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|22.28||||0.005|TWO_SIDED|95.0|13.55|31.0||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||31.00|13.55|0.005
71117472|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|13.39||||0.035|TWO_SIDED|95.0|6.28|20.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.50|6.28|0.035
71117473|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|20.14||||0.001|TWO_SIDED|95.0|8.67|31.62||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||31.62|8.67|0.001
71117474|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|9.56||||0.088|TWO_SIDED|95.0|-1.39|20.51||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.51|-1.39|0.088
71117475|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|9.36||||0.1|TWO_SIDED|95.0|-1.73|20.45||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.45|-1.73|0.100
71117476|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|62.54|||<|0.001|TWO_SIDED|95.0|50.93|74.15||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.15|50.93|<0.001
71117477|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|51.66|||<|0.001|TWO_SIDED|95.0|39.5|63.82||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||63.82|39.50|<0.001
70941275|NCT00475735|141382854|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Since this is a proof of concept study with one primary hypothesis (AISRS total score for MK-0249 vs. placebo), there is no multiplicity adjustment.|Mixed Models Analysis|The terms were tobacco use, prior stimulant use, time, site, period, sequence, treatment, period-by-time, sequence-by-time, and treatment-by-time.||||||0.001
70941276|NCT00125853|141382903|OTHER|"Linear Mixed effect Modelling, adjusted for baseline values and period effect~Difference of LSMeans treatment effect (SE) = 0.05 (0.09)"||||||0.6|||||||Linear Mixed effect Modelling, adjusted|||Comparing treatment effects on ISI||||0.60
71077446|NCT03304184|141664129|EQUIVALENCE|In this analysis, the null hypothesis was that there was no significant difference in 49 questions on oral health related quality of life scores between the two treatment groups (Photac and Biodentine).|Mean Difference (Final Values)|3.0||||0.091|TWO_SIDED|95.0||||Comparison between two groups for treatment|ANOVA||The estimation values were from an average of all values in each arm.|Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.||||.0910
71077447|NCT03304184|141664129|EQUIVALENCE|In this analysis, the null hypothesis was that there was no significant difference in 49 questions on oral health related quality of life scores between the two treatment groups (Photac and Biodentine) over time points|Mean Difference (Final Values)|3.0||||0.0262|TWO_SIDED|95.0||||Comparison between the two arms for treatment time points with analysis|ANOVA||The estimation values were from an average of all values in each arm.|Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.||||.0262
71117478|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|64.68|||<|0.001|TWO_SIDED|95.0|52.92|76.43||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||76.43|52.92|<0.001
71117479|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|52.03|||<|0.001|TWO_SIDED|95.0|40.43|63.63||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||63.63|40.43|<0.001
71117480|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|10.66||||0.138|TWO_SIDED|95.0|-3.04|24.35||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||24.35|-3.04|0.138
71117481|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-0.59||||0.935|TWO_SIDED|95.0|-14.71|13.52||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.52|-14.71|0.935
71117482|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|13.3||||0.063|TWO_SIDED|95.0|-0.57|27.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||27.17|-0.57|0.063
71117483|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.68|||<|0.001|TWO_SIDED|95.0|62.82|86.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.53|62.82|<0.001
71117484|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|63.18|||<|0.001|TWO_SIDED|95.0|50.42|75.95||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||75.95|50.42|<0.001
71117485|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.39|||<|0.001|TWO_SIDED|95.0|59.21|83.57||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.57|59.21|<0.001
71117486|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|60.5|||<|0.001|TWO_SIDED|95.0|47.89|73.11||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||73.11|47.89|<0.001
71117487|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|14.43||||0.027|TWO_SIDED|95.0|1.97|26.89||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||26.89|1.97|0.027
71117488|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.35||||0.729|TWO_SIDED|95.0|-10.91|15.61||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.61|-10.91|0.729
71117489|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|11.33||||0.087|TWO_SIDED|95.0|-1.55|24.21||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||24.21|-1.55|0.087
71077448|NCT03304184|141664130|EQUIVALENCE|In this analysis, the null hypothesis was that there was no significant difference in brief pain inventory scores between the two treatment groups (Photac and Biodentine) over different time points.|Mean Difference (Final Values)|3.0||||0.0289|TWO_SIDED|95.0|||||ANOVA||The estimation values were from an average of all values in each arm.|Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.||||.0289
71077449|NCT03230838|141664131|OTHER|The Miettinen \& Nurminen method was used.|Percentage Difference|-1.6|||||TWO_SIDED|95.0|-19.7|17.9|||||Ceftolozane/Tazobactam (C/T) minus Meropenem (Mero)|Difference in Percentage (C/T minus Mero)||17.9|-19.7|
71117490|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|75.6|||<|0.001|TWO_SIDED|95.0|62.5|88.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||88.70|62.50|<0.001
71117491|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|67.45|||<|0.001|TWO_SIDED|95.0|53.65|81.24||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.24|53.65|<0.001
71117492|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.46|||<|0.001|TWO_SIDED|95.0|61.21|87.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||87.70|61.21|<0.001
71117493|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|64.23|||<|0.001|TWO_SIDED|95.0|50.3|78.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||78.17|50.30|<0.001
71117494|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|11.59||||0.052|TWO_SIDED|95.0|0.12|23.06||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||23.06|0.12|0.052
71117495|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.84||||0.652|TWO_SIDED|95.0|-9.49|15.16||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.16|-9.49|0.652
71117496|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|10.28||||0.09|TWO_SIDED|95.0|-1.47|22.03||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||22.03|-1.47|0.090
71117497|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|79.93|||<|0.001|TWO_SIDED|95.0|67.41|92.46||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||92.46|67.41|<0.001
70941277|NCT00125853|141382904|OTHER|"Linear Mixed effect Model, adjusted for baseline values and period effect~Difference of LSMeans treatment effect (SE)~= -2.59 (1.34)"||||||0.06|||||||Linear Mixed effect Model, adjusted for|||Comparing treatment effects on ABPM||||0.06
71077450|NCT03230838|141664132|OTHER|The Miettinen \& Nurminen method was used.|Percentage Difference|1.0|||||TWO_SIDED|95.0|-9.5|5.5|||||C/T minus Mero|Difference in Percentage (C/T minus Mero)||5.5|-9.5|
71117498|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.65|||<|0.001|TWO_SIDED|95.0|58.25|85.05||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.05|58.25|<0.001
71077451|NCT03230838|141664133|OTHER|The Miettinen \& Nurminen method stratified by age group with Cochran- Mantel-Haenszel (CMH) weights was used. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Percentage Difference|-7.3|||||TWO_SIDED|95.0|-17.99|10.05|||||C/T minus Mero|Difference in Percentage (C/T minus Mero)||10.05|-17.99|
71077452|NCT03230838|141664134|OTHER|The Miettinen \& Nurminen method stratified by age group with Cochran- Mantel-Haenszel (CMH) weights was used. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Percentage Difference|-5.6|||||TWO_SIDED|95.0|-14.09|8.88|||||C/T minus Mero|Difference in Percentage (C/T minus Mero)||8.88|-14.09|
71077453|NCT03230838|141664135|OTHER|The Miettinen \& Nurminen method stratified by age group with Cochran- Mantel-Haenszel (CMH) weights was used. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Percentage Difference|-3.0|||||TWO_SIDED|95.0|-17.13|17.4|||||C/T minus Mero|Difference in Percentage (C/T minus Mero)||17.40|-17.13|
71077454|NCT03230838|141664136|OTHER|The Miettinen \& Nurminen method stratified by age group with CMH weights was used. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Percentage Difference|-3.4|||||TWO_SIDED|95.0|-12.67|13.41|||||C/T minus Mero|Difference in Percentage (C/T minus Mero)||13.41|-12.67|
71077455|NCT01505179|141664137|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||||||0.47
71077456|NCT01505179|141664138|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
71077457|NCT01505179|141664139|SUPERIORITY|||||||0.74|||||||t-test, 2 sided|||||||0.74
71077458|NCT01505179|141664140|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||||||0.49
71077459|NCT01096680|141664147|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.0|||<|0.0001|TWO_SIDED|95.0|5.0|10.9|||Mixed Models Analysis|||||10.9|5.0|<0.0001
71077460|NCT01096680|141664147|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.6|||<|0.0001|TWO_SIDED|95.0|10.2|15.0|||Mixed Models Analysis|||||15.0|10.2|<0.0001
71077461|NCT01096680|141664147|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.0|||<|0.0001|TWO_SIDED|95.0|11.7|16.2|||Mixed Models Analysis|||||16.2|11.7|<0.0001
71077462|NCT01096680|141664147|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.3|||<|0.0001|TWO_SIDED|95.0|9.9|14.7|||Mixed Models Analysis|||||14.7|9.9|<0.0001
71077463|NCT01096680|141664147|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.3||||0.0014|TWO_SIDED|95.0|-6.9|-1.8|||Mixed Models Analysis|||||-1.8|-6.9|0.0014
71077464|NCT01096680|141664147|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3||||0.7601|TWO_SIDED|95.0|-1.5|2.1|||Mixed Models Analysis|||||2.1|-1.5|0.7601
71077465|NCT01096680|141664147|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.7||||0.0351|TWO_SIDED|95.0|0.1|3.2|||Mixed Models Analysis|||||3.2|0.1|0.0351
71077466|NCT01096680|141664148|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.1123|TWO_SIDED|95.0|-1.1|0.1|||Mixed Models Analysis|||||0.1|-1.1|0.1123
71077467|NCT01096680|141664148|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0002|TWO_SIDED|95.0|-1.8|-0.6|||Mixed Models Analysis|||||-0.6|-1.8|0.0002
71077468|NCT01096680|141664148|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.2|-1.0|||Mixed Models Analysis|||||-1.0|-2.2|<0.0001
71077469|NCT01096680|141664148|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.0947|TWO_SIDED|95.0|-1.1|0.1|||Mixed Models Analysis|||||0.1|-1.1|0.0947
71077470|NCT01096680|141664148|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9393|TWO_SIDED|95.0|-0.6|0.6|||Mixed Models Analysis|||||0.6|-0.6|0.9393
71077471|NCT01096680|141664148|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.0297|TWO_SIDED|95.0|-1.3|-0.1|||Mixed Models Analysis|||||-0.1|-1.3|0.0297
71077472|NCT01096680|141664148|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.0004|TWO_SIDED|95.0|-1.7|-0.5|||Mixed Models Analysis|||||-0.5|-1.7|0.0004
71077473|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.7758|TWO_SIDED|95.0|-0.5|0.6|||Mixed Models Analysis|||7:50pm||0.6|-0.5|0.7758
71077474|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.1798|TWO_SIDED|95.0|-0.2|0.9|||Mixed Models Analysis|||7:50pm||0.9|-0.2|0.1798
71077475|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.609|TWO_SIDED|95.0|-0.4|0.7|||Mixed Models Analysis|||7:50pm||0.7|-0.4|0.6090
71077476|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.1169|TWO_SIDED|95.0|-0.1|1.0|||Mixed Models Analysis|||7:50pm||1.0|-0.1|0.1169
71077477|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.3028|TWO_SIDED|95.0|-0.8|0.3|||Mixed Models Analysis|||7:50pm||0.3|-0.8|0.3028
71077478|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9831|TWO_SIDED|95.0|-0.5|0.5|||Mixed Models Analysis|||7:50pm||0.5|-0.5|0.9831
71077479|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.2887|TWO_SIDED|95.0|-0.8|0.2|||Mixed Models Analysis|||7:50pm||0.2|-0.8|0.2887
71077480|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.4395|TWO_SIDED|95.0|-0.8|0.3|||Mixed Models Analysis|||8:50pm||0.3|-0.8|0.4395
71077481|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9019|TWO_SIDED|95.0|-0.5|0.6|||Mixed Models Analysis|||8:50pm||0.6|-0.5|0.9019
71077482|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.3419|TWO_SIDED|95.0|-0.8|0.3|||Mixed Models Analysis|||8:50pm||0.3|-0.8|0.3419
70941278|NCT00125853|141382905|OTHER|"Linear Mixed effect Model, adjusted for baseline values and period effect~Difference of LSMeans treatment effect (SE)~= -0/09 (0.14)"||||||0.51|||||||Linear Mixed effect Modelling, adjusted|||Comparing treatment effects on total cholesterol||||0.51
71077483|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9581|TWO_SIDED|95.0|-0.6|0.5|||Mixed Models Analysis|||8:50pm||0.5|-0.6|0.9581
71077484|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.2572|TWO_SIDED|95.0|-0.9|0.2|||Mixed Models Analysis|||8:50pm||0.2|-0.9|0.2572
71117499|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|78.92|||<|0.001|TWO_SIDED|95.0|66.29|91.56||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||91.56|66.29|<0.001
71117500|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|70.56|||<|0.001|TWO_SIDED|95.0|57.04|84.07||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.07|57.04|<0.001
71117501|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|9.61||||0.069|TWO_SIDED|95.0|-0.59|19.8||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||19.80|-0.59|0.069
71117502|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|0.65||||0.911|TWO_SIDED|95.0|-10.73|12.03||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.03|-10.73|0.911
71117503|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.27||||0.127|TWO_SIDED|95.0|-2.23|18.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.77|-2.23|0.127
71117504|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|76.55|||<|0.001|TWO_SIDED|95.0|62.37|90.72||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||90.72|62.37|<0.001
71117505|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|70.6|||<|0.001|TWO_SIDED|95.0|55.93|85.28||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.28|55.93|<0.001
71117506|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|76.5|||<|0.001|TWO_SIDED|95.0|62.22|90.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||90.79|62.22|<0.001
71117507|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.05|||<|0.001|TWO_SIDED|95.0|53.02|83.09||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.09|53.02|<0.001
71117508|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.57||||0.098|TWO_SIDED|95.0|-1.47|18.61||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.61|-1.47|0.098
71117509|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.01||||0.721|TWO_SIDED|95.0|-9.02|13.04||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.04|-9.02|0.721
71077485|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1||||0.8085|TWO_SIDED|95.0|-0.6|0.5|||Mixed Models Analysis|||8:50pm||0.5|-0.6|0.8085
71077486|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.3678|TWO_SIDED|95.0|-0.8|0.3|||Mixed Models Analysis|||8:50pm||0.3|-0.8|0.3678
71077487|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.3732|TWO_SIDED|95.0|-0.9|0.4|||Mixed Models Analysis|||9:50pm||0.4|-0.9|0.3732
71077488|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.4924|TWO_SIDED|95.0|-0.9|0.4|||Mixed Models Analysis|||9:50pm||0.4|-0.9|0.4924
70854010|NCT03595618|141195984|SUPERIORITY||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.02585||0.939|TWO_SIDED|95.0|-0.03868|0.06267||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% confidence interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose minus placebo using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.06267|-0.03868|0.939
70941279|NCT00125853|141382906|OTHER|"Linear Mixed effect Model, adjusted for baseline values and period effect~Difference of LSMeans treatment effect (SE) =0.02 (0.03)"||||||0.48|||||||Linear Mixed effect Modelling, adjusted|||Comparing treatment effects on HbA1c||||0.48
71077489|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9798|TWO_SIDED|95.0|-0.7|0.6|||Mixed Models Analysis|||9:50pm||0.6|-0.7|0.9798
71077490|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.8557|TWO_SIDED|95.0|-0.6|0.7|||Mixed Models Analysis|||9:50pm||0.7|-0.6|0.8557
71077491|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.0998|TWO_SIDED|95.0|-1.2|0.1|||Mixed Models Analysis|||9:50pm||0.1|-1.2|0.0998
71077492|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.1479|TWO_SIDED|95.0|-1.1|0.2|||Mixed Models Analysis|||9:50pm||0.2|-1.1|0.1479
71077493|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1||||0.8358|TWO_SIDED|95.0|-0.7|0.6|||Mixed Models Analysis|||9:50pm||0.6|-0.7|0.8358
71077494|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.0199|TWO_SIDED|95.0|-1.6|-0.1|||Mixed Models Analysis|||10:50pm||-0.1|-1.6|0.0199
71077495|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1||||0.7625|TWO_SIDED|95.0|-0.9|0.6|||Mixed Models Analysis|||10:50pm||0.6|-0.9|0.7625
71077496|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.1936|TWO_SIDED|95.0|-1.2|0.3|||Mixed Models Analysis|||10:50pm||0.3|-1.2|0.1936
71077497|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3||||0.4534|TWO_SIDED|95.0|-0.5|1.0|||Mixed Models Analysis|||10:50pm||1.0|-0.5|0.4534
71077498|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0012|TWO_SIDED|95.0|-2.0|-0.5|||Mixed Models Analysis|||10:50pm||-0.5|-2.0|0.0012
70941280|NCT00125853|141382907|OTHER|"Linear Mixed effect Model, adjusted for baseline values and period effect~Difference of LSMeans treatment effect (SE)~= -0.21(0.13)"||||||0.09|||||||Linear Mixed effect Modelling, adjusted|||Comparing treatment effects on BMI||||0.09
71077499|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.2072|TWO_SIDED|95.0|-1.2|0.3|||Mixed Models Analysis|||10:50pm||0.3|-1.2|0.2072
71077500|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.0413|TWO_SIDED|95.0|-1.5|0.0|||Mixed Models Analysis|||10:50pm||0.0|-1.5|0.0413
71077501|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.1086|TWO_SIDED|95.0|-1.5|0.1|||Mixed Models Analysis|||11:50pm||0.1|-1.5|0.1086
71077502|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.5843|TWO_SIDED|95.0|-1.0|0.6|||Mixed Models Analysis|||11:50pm||0.6|-1.0|0.5843
71077503|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.0571|TWO_SIDED|95.0|-1.6|0.0|||Mixed Models Analysis|||11:50pm||0.0|-1.6|0.0571
71077504|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.3965|TWO_SIDED|95.0|-1.2|0.5|||Mixed Models Analysis|||11:50pm||0.5|-1.2|0.3965
71077505|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.0009|TWO_SIDED|95.0|-2.2|-0.6|||Mixed Models Analysis|||11:50pm||-0.6|-2.2|0.0009
71077506|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.0211|TWO_SIDED|95.0|-1.8|-0.1|||Mixed Models Analysis|||11:50pm||-0.1|-1.8|0.0211
71077507|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.2863|TWO_SIDED|95.0|-1.2|0.4|||Mixed Models Analysis|||11:50pm||0.4|-1.2|0.2863
71077508|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.0428|TWO_SIDED|95.0|-1.7|0.0|||Mixed Models Analysis|||12:50am||0.0|-1.7|0.0428
71077509|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.3757|TWO_SIDED|95.0|-0.5|1.2|||Mixed Models Analysis|||12:50am||1.2|-0.5|0.3757
71077510|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.0002|TWO_SIDED|95.0|-2.4|-0.8|||Mixed Models Analysis|||12:50am||-0.8|-2.4|0.0002
71077511|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.3535|TWO_SIDED|95.0|-1.2|0.4|||Mixed Models Analysis|||12:50am||0.4|-1.2|0.3535
71077512|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.7|-1.1|||Mixed Models Analysis|||12:50am||-1.1|-2.7|<0.0001
71077513|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.1131|TWO_SIDED|95.0|-1.5|0.2|||Mixed Models Analysis|||12:50am||0.2|-1.5|0.1131
71077514|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0039|TWO_SIDED|95.0|-2.0|-0.4|||Mixed Models Analysis|||12:50am||-0.4|-2.0|0.0039
71077515|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.1302|TWO_SIDED|95.0|-1.5|0.2|||Mixed Models Analysis|||1:50am||0.2|-1.5|0.1302
71077516|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.6138|TWO_SIDED|95.0|-0.6|1.1|||Mixed Models Analysis|||1:50am||1.1|-0.6|0.6138
71077517|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5||||0.0008|TWO_SIDED|95.0|-2.3|-0.6|||Mixed Models Analysis|||1:50am||-0.6|-2.3|0.0008
71077518|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.1643|TWO_SIDED|95.0|-1.5|0.3|||Mixed Models Analysis|||1:50am||0.3|-1.5|0.1643
71077519|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.7||||0.0002|TWO_SIDED|95.0|-2.5|-0.8|||Mixed Models Analysis|||1:50am||-0.8|-2.5|0.0002
71077520|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.0782|TWO_SIDED|95.0|-1.6|0.1|||Mixed Models Analysis|||1:50am||0.1|-1.6|0.0782
71117510|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.28||||0.115|TWO_SIDED|95.0|-1.85|18.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.41|-1.85|0.115
71117511|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|77.66|||<|0.001|TWO_SIDED|95.0|63.63|91.69||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||91.69|63.63|<0.001
71117512|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.65|||<|0.001|TWO_SIDED|95.0|57.07|86.22||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.22|57.07|<0.001
71117513|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|76.5|||<|0.001|TWO_SIDED|95.0|62.22|90.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||90.79|62.22|<0.001
71117514|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.1|||<|0.001|TWO_SIDED|95.0|54.14|84.06||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.06|54.14|<0.001
71117515|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.56||||0.086|TWO_SIDED|95.0|-1.15|18.27||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.27|-1.15|0.086
70941281|NCT03575572|141382914|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
70941282|NCT03575572|141382914|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
70941283|NCT03575572|141382916|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
70941284|NCT03575572|141382916|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
70941285|NCT04405089|141382922|OTHER||Linear regression|0.03|||||TWO_SIDED|||||||||Linear regression (number of traumatic brain injuries versus Binge Eating Scale score at baseline).||||
71077521|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.0441|TWO_SIDED|95.0|-1.7|0.0|||Mixed Models Analysis|||1:50am||0.0|-1.7|0.0441
71077522|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0193|TWO_SIDED|95.0|-2.2|-0.2|||Mixed Models Analysis|||2:50am||-0.2|-2.2|0.0193
71117516|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.01||||0.714|TWO_SIDED|95.0|-8.76|12.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.77|-8.76|0.714
71117517|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|7.21||||0.164|TWO_SIDED|95.0|-2.8|17.22||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.22|-2.80|0.164
71117518|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.38|||<|0.001|TWO_SIDED|95.0|59.56|89.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||89.20|59.56|<0.001
71117519|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.5|||<|0.001|TWO_SIDED|95.0|54.29|84.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.70|54.29|<0.001
71117520|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|73.24|||<|0.001|TWO_SIDED|95.0|58.18|88.3||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||88.30|58.18|<0.001
71117521|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|67.0|||<|0.001|TWO_SIDED|95.0|51.4|82.61||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||82.61|51.40|<0.001
71117522|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|7.46||||0.129|TWO_SIDED|95.0|-2.12|17.04||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.04|-2.12|0.129
70941286|NCT04405089|141382923|OTHER||Linear regression|-0.33|||||TWO_SIDED|||||||||Linear regression (number of traumatic brain injuries versus NIH Flanker score at baseline).||||
70941287|NCT04405089|141382924|OTHER||Linear regression|0.04|||||TWO_SIDED|||||||||Linear regression (number of traumatic brain injuries versus NIH Set Shifting score at baseline).||||
70941288|NCT00179478|141382925|SUPERIORITY|||||||0.001||||||Based on adjusted Hazard Ratio (HR)|Regression, Cox|HR adjusted for age, onset event type, baseline brain MRI T2 lesion and number and baseline number of gad enhancing lesions||||||0.001
70941289|NCT00179478|141382926|SUPERIORITY|||||||0.02||||||a priori threshold for statistical significance was a p value less than 0.01|Wilcoxon (Mann-Whitney)|||||||0.02
70941290|NCT00179478|141382927|SUPERIORITY|||||||0.61||||||a priori threshold for statistical significance was a p value \< 0.01|Fisher Exact|||||||0.61
70941291|NCT00179478|141382928|SUPERIORITY|||||||0.5||||||a priori threshold for statistical significant was a p value less than 0.01|Fisher Exact|||||||0.50
70941292|NCT00157209|141382930|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.745||||0.045|TWO_SIDED|95.0|0.533|1.042|||Log Rank|||||1.042|0.533|0.045
70941293|NCT03751280|141382934|OTHER||Comparison of adjusted least square mean|0.61|STANDARD_ERROR_OF_MEAN|1.2|||TWO_SIDED|90.0|-1.4|2.6|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 29||2.6|-1.4|
70941294|NCT03751280|141382934|OTHER||Comparison of adjusted least square mean|0.8|STANDARD_ERROR_OF_MEAN|1.279|||TWO_SIDED|90.0|-1.3|2.9|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 57||2.9|-1.3|
71077523|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.7071|TWO_SIDED|95.0|-1.2|0.8|||Mixed Models Analysis|||2:50am||0.8|-1.2|0.7071
71077524|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9||||0.0002|TWO_SIDED|95.0|-2.9|-0.9|||Mixed Models Analysis|||2:50am||-0.9|-2.9|0.0002
71077525|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.0611|TWO_SIDED|95.0|-1.9|0.0|||Mixed Models Analysis|||2:50am||0.0|-1.9|0.0611
71077526|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.2|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.2|||Mixed Models Analysis|||2:50am||-1.2|-3.2|<0.0001
71077527|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.016|TWO_SIDED|95.0|-2.2|-0.2|||Mixed Models Analysis|||2:50am||-0.2|-2.2|0.0160
71077528|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.048|TWO_SIDED|95.0|-2.0|0.0|||Mixed Models Analysis|||2:50am||0.0|-2.0|0.0480
71077529|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0234|TWO_SIDED|95.0|-2.2|-0.2|||Mixed Models Analysis|||3:50am||-0.2|-2.2|0.0234
71077530|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.5624|TWO_SIDED|95.0|-1.3|0.7|||Mixed Models Analysis|||3:50am||0.7|-1.3|0.5624
71077531|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.5|-1.5|||Mixed Models Analysis|||3:50am||-1.5|-3.5|<0.0001
71077532|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.0022|TWO_SIDED|95.0|-2.6|-0.6|||Mixed Models Analysis|||3:50am||-0.6|-2.6|0.0022
71077533|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.7|||<|0.0001|TWO_SIDED|95.0|-3.7|-1.6|||Mixed Models Analysis|||3:50am||-1.6|-3.7|<0.0001
71077534|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8||||0.0008|TWO_SIDED|95.0|-2.8|-0.8|||Mixed Models Analysis|||3:50am||-0.8|-2.8|0.0008
71077535|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.0883|TWO_SIDED|95.0|-1.9|0.1|||Mixed Models Analysis|||3:50am||0.1|-1.9|0.0883
71077536|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.3093|TWO_SIDED|95.0|-1.5|0.5|||Mixed Models Analysis|||4:50am||0.5|-1.5|0.3093
71077537|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.8871|TWO_SIDED|95.0|-0.9|1.1|||Mixed Models Analysis|||4:50am||1.1|-0.9|0.8871
71117523|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.97||||0.712|TWO_SIDED|95.0|-8.5|12.43||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.43|-8.50|0.712
71077538|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.2|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.2|||Mixed Models Analysis|||4:50am||-1.2|-3.2|<0.0001
71077539|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.0022|TWO_SIDED|95.0|-2.6|-0.6|||Mixed Models Analysis|||4:50am||-0.6|-2.6|0.0022
71077540|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.4|||<|0.0001|TWO_SIDED|95.0|-3.4|-1.4|||Mixed Models Analysis|||4:50am||-1.4|-3.4|<0.0001
71077541|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8||||0.0006|TWO_SIDED|95.0|-2.8|-0.8|||Mixed Models Analysis|||4:50am||-0.8|-2.8|0.0006
71077542|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.2462|TWO_SIDED|95.0|-1.6|0.4|||Mixed Models Analysis|||4:50am||0.4|-1.6|0.2462
71077543|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.4427|TWO_SIDED|95.0|-1.4|0.6|||Mixed Models Analysis|||5:50am||0.6|-1.4|0.4427
71077544|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.4405|TWO_SIDED|95.0|-0.6|1.4|||Mixed Models Analysis|||5:50am||1.4|-0.6|0.4405
71077545|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.0003|TWO_SIDED|95.0|-3.0|-0.9|||Mixed Models Analysis|||5:50am||-0.9|-3.0|0.0003
71077546|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0279|TWO_SIDED|95.0|-2.2|-0.1|||Mixed Models Analysis|||5:50am||-0.1|-2.2|0.0279
71077547|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.5|-1.5|||Mixed Models Analysis|||5:50am||-1.5|-3.5|<0.0001
71077548|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.7||||0.0015|TWO_SIDED|95.0|-2.7|-0.7|||Mixed Models Analysis|||5:50am||-0.7|-2.7|0.0015
71077549|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.1246|TWO_SIDED|95.0|-1.8|0.2|||Mixed Models Analysis|||5:50am||0.2|-1.8|0.1246
71077550|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.3067|TWO_SIDED|95.0|-1.6|0.5|||Mixed Models Analysis|||6:50am||0.5|-1.6|0.3067
71077551|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.894|TWO_SIDED|95.0|-1.0|1.1|||Mixed Models Analysis|||6:50am||1.1|-1.0|0.8940
71077552|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.0034|TWO_SIDED|95.0|-2.7|-0.5|||Mixed Models Analysis|||6:50am||-0.5|-2.7|0.0034
71077553|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.0708|TWO_SIDED|95.0|-2.0|0.1|||Mixed Models Analysis|||6:50am||0.1|-2.0|0.0708
71077554|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.6|-1.4|||Mixed Models Analysis|||6:50am||-1.4|-3.6|<0.0001
71077555|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9||||0.0006|TWO_SIDED|95.0|-2.9|-0.8|||Mixed Models Analysis|||6:50am||-0.8|-2.9|0.0006
71077556|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.2476|TWO_SIDED|95.0|-1.7|0.4|||Mixed Models Analysis|||6:50am||0.4|-1.7|0.2476
71077557|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.231|TWO_SIDED|95.0|-1.8|0.4|||Mixed Models Analysis|||7:50am||0.4|-1.8|0.2310
71077558|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1||||0.8369|TWO_SIDED|95.0|-1.2|1.0|||Mixed Models Analysis|||7:50am||1.0|-1.2|0.8369
71077559|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.0035|TWO_SIDED|95.0|-2.7|-0.5|||Mixed Models Analysis|||7:50am||-0.5|-2.7|0.0035
71077560|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.0498|TWO_SIDED|95.0|-2.2|0.0|||Mixed Models Analysis|||7:50am||0.0|-2.2|0.0498
71077561|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.6|-1.4|||Mixed Models Analysis|||7:50am||-1.4|-3.6|<0.0001
71077562|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9||||0.0007|TWO_SIDED|95.0|-3.0|-0.8|||Mixed Models Analysis|||7:50am||-0.8|-3.0|0.0007
71077563|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.3198|TWO_SIDED|95.0|-1.6|0.5|||Mixed Models Analysis|||7:50am||0.5|-1.6|0.3198
70854011|NCT03595618|141195984|SUPERIORITY||Adjusted mean difference|0.02329|STANDARD_ERROR_OF_MEAN|0.02536||0.682|TWO_SIDED|95.0|-0.02641|0.073|||Mixed Models Analysis||Two-sided 95% confidence interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose minus placebo using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.07300|-0.02641|0.682
70854012|NCT03595618|141195985|SUPERIORITY||Odds Ratio (OR)|1.47|STANDARD_ERROR_OF_MEAN|0.29||0.396|TWO_SIDED|95.0|0.84|2.58||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Logistic Model||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Estimate (Standard Error of log \[estimate\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen||2.58|0.84|0.396
70854013|NCT03595618|141195985|SUPERIORITY||Odds Ratio (OR)|0.89|STANDARD_ERROR_OF_MEAN|0.26||0.951|TWO_SIDED|95.0|0.53|1.5||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Logistic Model||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Estimate (Standard Error of log \[estimate\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen||1.50|0.53|0.951
71077564|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5||||0.375|TWO_SIDED|95.0|-0.6|1.7|||Mixed Models Analysis|||8:50am||1.7|-0.6|0.3750
70854014|NCT03595618|141195985|SUPERIORITY||Odds Ratio (OR)|1.08|STANDARD_ERROR_OF_MEAN|0.27||0.985|TWO_SIDED|95.0|0.64|1.83||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Logistic Model||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Estimate (Standard Error of log \[estimate\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen||1.83|0.64|0.985
70854015|NCT03595618|141195986|SUPERIORITY||Adjusted mean difference|-2.1|STANDARD_ERROR_OF_MEAN|1.7||0.467|TWO_SIDED|95.0|-5.6|1.3||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Total score: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||1.3|-5.6|0.467
70941295|NCT03751280|141382934|OTHER||Comparison of adjusted least square mean|2.73|STANDARD_ERROR_OF_MEAN|1.611||0.0931|TWO_SIDED|90.0|0.1|5.4|||t-test, 2 sided||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 85||5.4|0.1|0.0931
71077565|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.7978|TWO_SIDED|95.0|-1.3|1.0|||Mixed Models Analysis|||8:50am||1.0|-1.3|0.7978
71077566|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.5197|TWO_SIDED|95.0|-1.5|0.8|||Mixed Models Analysis|||8:50am||0.8|-1.5|0.5197
71077567|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.0751|TWO_SIDED|95.0|-2.2|0.1|||Mixed Models Analysis|||8:50am||0.1|-2.2|0.0751
71077568|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.1079|TWO_SIDED|95.0|-2.1|0.2|||Mixed Models Analysis|||8:50am||0.2|-2.1|0.1079
71077569|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.0065|TWO_SIDED|95.0|-2.8|-0.5|||Mixed Models Analysis|||8:50am||-0.5|-2.8|0.0065
71077570|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7||||0.2529|TWO_SIDED|95.0|-0.5|1.8|||Mixed Models Analysis|||8:50am||1.8|-0.5|0.2529
71077571|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.6364|TWO_SIDED|95.0|-1.3|0.8|||Mixed Models Analysis|||9:50am||0.8|-1.3|0.6364
71077572|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9417|TWO_SIDED|95.0|-1.1|1.0|||Mixed Models Analysis|||9:50am||1.0|-1.1|0.9417
71077573|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3||||0.02|TWO_SIDED|95.0|-2.3|-0.2|||Mixed Models Analysis|||9:50am||-0.2|-2.3|0.0200
71077574|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.0527|TWO_SIDED|95.0|-2.1|0.0|||Mixed Models Analysis|||9:50am||0.0|-2.1|0.0527
71077575|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.0107|TWO_SIDED|95.0|-2.5|-0.3|||Mixed Models Analysis|||9:50am||-0.3|-2.5|0.0107
71077576|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0303|TWO_SIDED|95.0|-2.2|-0.1|||Mixed Models Analysis|||9:50am||-0.1|-2.2|0.0303
71077577|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.6889|TWO_SIDED|95.0|-1.3|0.8|||Mixed Models Analysis|||9:50am||0.8|-1.3|0.6889
71077578|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9552|TWO_SIDED|95.0|-1.2|1.1|||Mixed Models Analysis|||10:50am||1.1|-1.2|0.9552
71077579|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.7558|TWO_SIDED|95.0|-1.0|1.3|||Mixed Models Analysis|||10:50am||1.3|-1.0|0.7558
71077580|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.1824|TWO_SIDED|95.0|-1.9|0.4|||Mixed Models Analysis|||10:50am||0.4|-1.9|0.1824
71077581|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.3323|TWO_SIDED|95.0|-1.7|0.6|||Mixed Models Analysis|||10:50am||0.6|-1.7|0.3323
71077582|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0413|TWO_SIDED|95.0|-2.4|0.0|||Mixed Models Analysis|||10:50am||0.0|-2.4|0.0413
71077583|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.0925|TWO_SIDED|95.0|-2.2|0.2|||Mixed Models Analysis|||10:50am||0.2|-2.2|0.0925
71077584|NCT01096680|141664149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.7133|TWO_SIDED|95.0|-1.4|0.9|||Mixed Models Analysis|||10:50am||0.9|-1.4|0.7133
71077585|NCT01096680|141664150|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.5|||<|0.0001|TWO_SIDED|95.0|-36.6|-16.5|||Mixed Models Analysis|||||-16.5|-36.6|<0.0001
71077586|NCT01096680|141664150|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-35.4|||<|0.0001|TWO_SIDED|95.0|-45.5|-25.4|||Mixed Models Analysis|||||-25.4|-45.5|<0.0001
71077587|NCT01096680|141664150|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.7|||<|0.0001|TWO_SIDED|95.0|-36.7|-16.6|||Mixed Models Analysis|||||-16.6|-36.7|<0.0001
70854016|NCT03595618|141195986|SUPERIORITY||Adjusted mean difference|-1.9|STANDARD_ERROR_OF_MEAN|1.8||0.557|TWO_SIDED|95.0|-5.4|1.5||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Total score: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||1.5|-5.4|0.557
71077588|NCT01096680|141664150|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.5|||<|0.0001|TWO_SIDED|95.0|-36.6|-16.5|||Mixed Models Analysis|||||-16.5|-36.6|<0.0001
71077589|NCT01096680|141664150|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9945|TWO_SIDED|95.0|-10.1|10.0|||Mixed Models Analysis|||||10.0|-10.1|0.9945
71077590|NCT01096680|141664150|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.9||||0.0814|TWO_SIDED|95.0|-18.9|1.1|||Mixed Models Analysis|||||1.1|-18.9|0.0814
71077591|NCT01096680|141664150|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.9743|TWO_SIDED|95.0|-10.2|9.9|||Mixed Models Analysis|||||9.9|-10.2|0.9743
71077592|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.6||||0.0544|TWO_SIDED|95.0|-19.4|0.2|||Mixed Models Analysis|||9:15pm||0.2|-19.4|0.0544
71077593|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8||||0.441|TWO_SIDED|95.0|-13.6|6.0|||Mixed Models Analysis|||9:15pm||6.0|-13.6|0.4410
71077594|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.1||||0.1046|TWO_SIDED|95.0|-17.9|1.7|||Mixed Models Analysis|||9:15pm||1.7|-17.9|0.1046
71077595|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.3||||0.6467|TWO_SIDED|95.0|-12.0|7.5|||Mixed Models Analysis|||9:15pm||7.5|-12.0|0.6467
71077596|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.4||||0.1971|TWO_SIDED|95.0|-16.2|3.4|||Mixed Models Analysis|||9:15pm||3.4|-16.2|0.1971
71077597|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.9052|TWO_SIDED|95.0|-10.4|9.2|||Mixed Models Analysis|||9:15pm||9.2|-10.4|0.9052
71077598|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.8||||0.242|TWO_SIDED|95.0|-15.6|4.0|||Mixed Models Analysis|||9:15pm||4.0|-15.6|0.2420
71077599|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.7||||0.0001|TWO_SIDED|95.0|-25.1|-8.3|||Mixed Models Analysis|||11:15pm||-8.3|-25.1|0.0001
71077600|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.3||||0.4321|TWO_SIDED|95.0|-5.0|11.6|||Mixed Models Analysis|||11:15pm||11.6|-5.0|0.4321
71077601|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.4|||<|0.0001|TWO_SIDED|95.0|-26.7|-10.1|||Mixed Models Analysis|||11:15pm||-10.1|-26.7|<0.0001
71077602|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6||||0.6999|TWO_SIDED|95.0|-6.7|9.9|||Mixed Models Analysis|||11:15pm||9.9|-6.7|0.6999
71077603|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.1|||<|0.0001|TWO_SIDED|95.0|-26.4|-9.8|||Mixed Models Analysis|||11:15pm||-9.8|-26.4|<0.0001
71077604|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.9||||0.6566|TWO_SIDED|95.0|-6.4|10.2|||Mixed Models Analysis|||11:15pm||10.2|-6.4|0.6566
71077605|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.0|||<|0.0001|TWO_SIDED|95.0|-28.3|-11.7|||Mixed Models Analysis|||11:15pm||-11.7|-28.3|<0.0001
71077606|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-25.2|||<|0.0001|TWO_SIDED|95.0|-36.1|-14.3|||Mixed Models Analysis|||1:15am||-14.3|-36.1|<0.0001
71077607|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5||||0.7824|TWO_SIDED|95.0|-12.4|9.4|||Mixed Models Analysis|||1:15am||9.4|-12.4|0.7824
71077608|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-25.1|||<|0.0001|TWO_SIDED|95.0|-36.0|-14.3|||Mixed Models Analysis|||1:15am||-14.3|-36.0|<0.0001
71077609|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5||||0.7867|TWO_SIDED|95.0|-12.4|9.4|||Mixed Models Analysis|||1:15am||9.4|-12.4|0.7867
71077610|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.5|||<|0.0001|TWO_SIDED|95.0|-37.4|-15.6|||Mixed Models Analysis|||1:15am||-15.6|-37.4|<0.0001
71077611|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.9||||0.6029|TWO_SIDED|95.0|-13.7|8.0|||Mixed Models Analysis|||1:15am||8.0|-13.7|0.6029
71077612|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-23.6|||<|0.0001|TWO_SIDED|95.0|-34.5|-12.8|||Mixed Models Analysis|||1:15am||-12.8|-34.5|<0.0001
71077613|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-37.1|||<|0.0001|TWO_SIDED|95.0|-50.1|-24.1|||Mixed Models Analysis|||3:15am||-24.1|-50.1|<0.0001
71077614|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1||||0.8684|TWO_SIDED|95.0|-11.9|14.1|||Mixed Models Analysis|||3:15am||14.1|-11.9|0.8684
71077615|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-53.3|||<|0.0001|TWO_SIDED|95.0|-66.3|-40.3|||Mixed Models Analysis|||3:15am||-40.3|-66.3|<0.0001
71077616|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.1||||0.0228|TWO_SIDED|95.0|-28.1|-2.1|||Mixed Models Analysis|||3:15am||-2.1|-28.1|0.0228
71077617|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-40.0|||<|0.0001|TWO_SIDED|95.0|-53.0|-27.0|||Mixed Models Analysis|||3:15am||-27.0|-53.0|<0.0001
71077618|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8||||0.7852|TWO_SIDED|95.0|-14.8|11.2|||Mixed Models Analysis|||3:15am||11.2|-14.8|0.7852
70854017|NCT03595618|141195986|SUPERIORITY||Adjusted mean difference|-1.9|STANDARD_ERROR_OF_MEAN|1.8||0.593|TWO_SIDED|95.0|-5.3|1.6||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Total score: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||1.6|-5.3|0.593
70854018|NCT03595618|141195986|SUPERIORITY||Adjusted mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.4||0.776|TWO_SIDED|95.0|-1.0|0.4||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Pain subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.4|-1.0|0.776
70854019|NCT03595618|141195986|SUPERIORITY||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.446|TWO_SIDED|95.0|-1.2|0.3||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Pain subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.3|-1.2|0.446
70854020|NCT03595618|141195986|SUPERIORITY||Adjusted mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.4||0.649|TWO_SIDED|95.0|-1.1|0.4||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Pain subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.4|-1.1|0.649
70854021|NCT03595618|141195986|SUPERIORITY||Adjusted mean difference|-1.6|STANDARD_ERROR_OF_MEAN|1.3||0.452|TWO_SIDED|95.0|-4.1|0.9||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Physical function subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.9|-4.1|0.452
70854022|NCT03595618|141195986|SUPERIORITY||Adjusted mean difference|-1.2|STANDARD_ERROR_OF_MEAN|1.3||0.665|TWO_SIDED|95.0|-3.7|1.3||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Physical Function subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||1.3|-3.7|0.665
71077619|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.2|||<|0.0001|TWO_SIDED|95.0|-51.2|-25.2|||Mixed Models Analysis|||3:15am||-25.2|-51.2|<0.0001
70854023|NCT03595618|141195986|SUPERIORITY||Adjusted mean difference|-1.3|STANDARD_ERROR_OF_MEAN|1.3||0.598|TWO_SIDED|95.0|-3.9|1.2||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Physical Function subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||1.2|-3.9|0.598
70854024|NCT03595618|141195986|SUPERIORITY||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4|TWO_SIDED|95.0|-0.6|0.1||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Stiffness subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.1|-0.6|0.400
70941296|NCT03751280|141382936|OTHER||Comparison of adjusted least square mean|0.21|STANDARD_ERROR_OF_MEAN|0.501|||TWO_SIDED|90.0|-0.6|1.0|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 29||1|-0.6|
71077620|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.2|||<|0.0001|TWO_SIDED|95.0|-51.3|-25.1|||Mixed Models Analysis|||5:15am||-25.1|-51.3|<0.0001
71077621|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.9||||0.5528|TWO_SIDED|95.0|-9.1|17.0|||Mixed Models Analysis|||5:15am||17.0|-9.1|0.5528
71077622|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-53.9|||<|0.0001|TWO_SIDED|95.0|-67.0|-40.9|||Mixed Models Analysis|||5:15am||-40.9|-67.0|<0.0001
70854025|NCT03595618|141195986|SUPERIORITY||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.393|TWO_SIDED|95.0|-0.6|0.1||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Stiffness subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.1|-0.6|0.393
70941297|NCT03751280|141382936|OTHER||Comparison of adjusted least square mean|0.61|STANDARD_ERROR_OF_MEAN|0.538|||TWO_SIDED|90.0|-0.3|1.5|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 57||1.5|-0.3|
71077623|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.8||||0.0747|TWO_SIDED|95.0|-24.9|1.2|||Mixed Models Analysis|||5:15am||1.2|-24.9|0.0747
71077624|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-49.2|||<|0.0001|TWO_SIDED|95.0|-62.2|-36.1|||Mixed Models Analysis|||5:15am||-36.1|-62.2|<0.0001
70941298|NCT03751280|141382936|OTHER||Comparison of adjusted least square mean|0.82|STANDARD_ERROR_OF_MEAN|0.648||0.2069|TWO_SIDED|90.0|-0.3|1.9|||t-test, 2 sided||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 85||1.9|-0.3|0.2069
71077625|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.1||||0.2868|TWO_SIDED|95.0|-20.1|6.0|||Mixed Models Analysis|||5:15am||6.0|-20.1|0.2868
71077626|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-42.1|||<|0.0001|TWO_SIDED|95.0|-55.2|-29.1|||Mixed Models Analysis|||5:15am||-29.1|-55.2|<0.0001
71077627|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-37.6||||0.0007|TWO_SIDED|95.0|-59.1|-16.2|||Mixed Models Analysis|||7:15am||-16.2|-59.1|0.0007
71077628|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.9089|TWO_SIDED|95.0|-22.7|20.2|||Mixed Models Analysis|||7:15am||20.2|-22.7|0.9089
70941299|NCT03751280|141382937|OTHER||Comparison of adjusted least square mean|0.51|STANDARD_ERROR_OF_MEAN|0.849|||TWO_SIDED|90.0|-0.9|1.9|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 29||1.9|-0.9|
71077629|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-52.9|||<|0.0001|TWO_SIDED|95.0|-74.3|-31.4|||Mixed Models Analysis|||7:15am||-31.4|-74.3|<0.0001
71077630|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.5||||0.1307|TWO_SIDED|95.0|-37.9|5.0|||Mixed Models Analysis|||7:15am||5.0|-37.9|0.1307
71077631|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-36.3||||0.0011|TWO_SIDED|95.0|-57.7|-14.8|||Mixed Models Analysis|||7:15am||-14.8|-57.7|0.0011
71077632|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.9903|TWO_SIDED|95.0|-21.3|21.6|||Mixed Models Analysis|||7:15am||21.6|-21.3|0.9903
71077633|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-36.4||||0.001|TWO_SIDED|95.0|-57.8|-14.9|||Mixed Models Analysis|||7:15am||-14.9|-57.8|0.0010
71077634|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-21.4||||0.1655|TWO_SIDED|95.0|-51.7|9.0|||Mixed Models Analysis|||9:15am||9.0|-51.7|0.1655
71077635|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.8975|TWO_SIDED|95.0|-32.4|28.5|||Mixed Models Analysis|||9:15am||28.5|-32.4|0.8975
71077636|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-36.2||||0.0199|TWO_SIDED|95.0|-66.5|-5.8|||Mixed Models Analysis|||9:15am||-5.8|-66.5|0.0199
71077637|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.8||||0.2785|TWO_SIDED|95.0|-47.2|13.7|||Mixed Models Analysis|||9:15am||13.7|-47.2|0.2785
71077638|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.3||||0.5048|TWO_SIDED|95.0|-40.6|20.1|||Mixed Models Analysis|||9:15am||20.1|-40.6|0.5048
71077639|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.1||||0.5533|TWO_SIDED|95.0|-21.3|39.6|||Mixed Models Analysis|||9:15am||39.6|-21.3|0.5533
71077640|NCT01096680|141664151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.4||||0.2098|TWO_SIDED|95.0|-49.9|11.1|||Mixed Models Analysis|||9:15am||11.1|-49.9|0.2098
71077641|NCT02697734|141664169|SUPERIORITY||Odds Ratio (OR)|43.4|||<|0.0001|TWO_SIDED|95.0|7.06|343.19|||Cochran-Mantel-Haenszel|||||343.19|7.06|<.0001
71077642|NCT02651688|141664210|SUPERIORITY|||||||0.7103|||||||Wilcoxon rank-sum test|||||||0.7103
71077643|NCT02651688|141664210|SUPERIORITY|||||||0.4529|||||||Wilcoxon rank-sum test|||||||0.4529
71077644|NCT02651688|141664211|SUPERIORITY|||||||0.9302|||||||Wilcoxon rank-sum test|||||||0.9302
71077645|NCT02651688|141664211|SUPERIORITY|||||||0.7509|||||||Wilcoxon rank-sum test|||||||0.7509
71077646|NCT02651688|141664212|SUPERIORITY|||||||0.5095|||||||Wilcoxon rank-sum test|||||||0.5095
71077647|NCT02651688|141664212|SUPERIORITY|||||||0.623|||||||Wilcoxon rank-sum test|||||||0.6230
71077648|NCT02651688|141664213|SUPERIORITY|||||||0.296|||||||Wilcoxon rank-sum test|||||||0.2960
71077649|NCT02651688|141664213|SUPERIORITY|||||||0.2723|||||||Wilcoxon rank-sum test|||||||0.2723
71077650|NCT02651688|141664214|SUPERIORITY|||||||0.0034|||||||Wilcoxon rank-sum test|||||||0.0034
71077651|NCT02651688|141664214|SUPERIORITY|||||||0.0027|||||||Wilcoxon rank-sum test|||||||0.0027
71077652|NCT02651688|141664215|SUPERIORITY|||||||0.0146|||||||Wilcoxon rank-sum test|||||||0.0146
71077653|NCT02651688|141664215|SUPERIORITY|||||||0.0018|||||||Wilcoxon rank-sum test|||||||0.0018
71077654|NCT02651688|141664216|SUPERIORITY|||||||0.1524|||||||Wilcoxon rank-sum test|||||||0.1524
71077655|NCT02651688|141664216|SUPERIORITY|||||||0.0227|||||||Wilcoxon rank-sum test|||||||0.0227
71077656|NCT02651688|141664217|SUPERIORITY|||||||0.5873|||||||Wilcoxon rank-sum test|||||||0.5873
71077657|NCT02651688|141664217|SUPERIORITY|||||||0.9509|||||||Wilcoxon rank-sum test|||||||0.9509
71077658|NCT02651688|141664218|SUPERIORITY|||||||0.4341|||||||Wilcoxon rank-sum test|||||||0.4341
71077659|NCT02651688|141664218|SUPERIORITY|||||||1|||||||Wilcoxon rank-sum test|||||||1.0000
71077660|NCT02651688|141664219|SUPERIORITY|||||||0.022|||||||Wilcoxon rank-sum test|||||||0.0220
71077661|NCT02651688|141664219|SUPERIORITY|||||||0.3677|||||||Wilcoxon rank-sum test|||||||0.3677
71077662|NCT02651688|141664220|SUPERIORITY|||||||0.9074|||||||Wilcoxon rank-sum test|||||||0.9074
71077663|NCT02651688|141664220|SUPERIORITY|||||||0.4517|||||||Wilcoxon rank-sum test|||||||0.4517
71077664|NCT02651688|141664221|SUPERIORITY|||||||0.2962|||||||Wilcoxon rank-sum test|||||||0.2962
71077665|NCT02651688|141664221|SUPERIORITY|||||||0.3261|||||||Wilcoxon rank-sum test|||||||0.3261
71077666|NCT02651688|141664222|SUPERIORITY|||||||0.045|||||||Wilcoxon rank-sum test|||||||0.0450
71077667|NCT02651688|141664222|SUPERIORITY|||||||0.2235|||||||Wilcoxon rank-sum test|||||||0.2235
71077668|NCT02651688|141664223|SUPERIORITY|||||||0.826|||||||Wilcoxon rank-sum test|||||||0.8260
71077669|NCT02651688|141664223|SUPERIORITY|||||||0.4183|||||||Wilcoxon rank-sum test|||||||0.4183
71077670|NCT02651688|141664224|SUPERIORITY|||||||0.1144|||||||Wilcoxon rank-sum test|||||||0.1144
71077671|NCT02651688|141664224|SUPERIORITY|||||||0.3263|||||||Wilcoxon rank-sum test|||||||0.3263
71077672|NCT02651688|141664225|SUPERIORITY|||||||0.1546|||||||Wilcoxon rank-sum test|||||||0.1546
71077673|NCT02651688|141664225|SUPERIORITY|||||||0.5732|||||||Wilcoxon rank-sum test|||||||0.5732
71077674|NCT02651688|141664226|SUPERIORITY|||||||0.5581|||||||Wilcoxon rank-sum test|||||||0.5581
71077675|NCT02651688|141664226|SUPERIORITY|||||||0.5833|||||||Wilcoxon rank-sum test|||||||0.5833
71077676|NCT02651688|141664227|SUPERIORITY|||||||0.0168|||||||Wilcoxon rank-sum test|||||||0.0168
71077677|NCT02651688|141664227|SUPERIORITY|||||||0.0364|||||||Wilcoxon rank-sum test|||||||0.0364
71077678|NCT02651688|141664228|SUPERIORITY|||||||0.0992|||||||Wilcoxon rank-sum test|||||||0.0992
71077679|NCT02651688|141664228|SUPERIORITY|||||||0.1333|||||||Wilcoxon rank-sum|||||||0.1333
71077680|NCT02651688|141664229|SUPERIORITY|||||||0.0139|||||||Wilcoxon rank-sum test|||||||0.0139
71077681|NCT02651688|141664229|SUPERIORITY|||||||0.0225|||||||Wilcoxon rank-sum test|||||||0.0225
70854026|NCT03595618|141195986|SUPERIORITY||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.858|TWO_SIDED|95.0|-0.5|0.2||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Stiffness subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.2|-0.5|0.858
70854027|NCT03595618|141195987|SUPERIORITY||Adjusted mean difference|-2.2|STANDARD_ERROR_OF_MEAN|2.5||0.705|TWO_SIDED|95.0|-7.1|2.7||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||2.7|-7.1|0.705
70854028|NCT03595618|141195987|SUPERIORITY||Adjusted mean difference|-4.1|STANDARD_ERROR_OF_MEAN|2.5||0.243|TWO_SIDED|95.0|-9.0|0.8||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||0.8|-9.0|0.243
70854029|NCT03595618|141195987|SUPERIORITY||Adjusted mean difference|-1.1|STANDARD_ERROR_OF_MEAN|2.5||0.949|TWO_SIDED|95.0|-6.1|3.9||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||3.9|-6.1|0.949
70854030|NCT03595618|141195988|SUPERIORITY||Adjusted mean difference|1.4|STANDARD_ERROR_OF_MEAN|2.5||0.89|TWO_SIDED|95.0|-3.4|6.3||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||6.3|-3.4|0.890
70854031|NCT03595618|141195988|SUPERIORITY||Adjusted mean difference|-2.3|STANDARD_ERROR_OF_MEAN|2.5||0.682|TWO_SIDED|95.0|-7.1|2.6||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||2.6|-7.1|0.682
71077682|NCT01578499|141664243|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|42.2|||<|0.001|TWO_SIDED|95.0|27.5|56.8||P-value was stratified by baseline disease diagnosis (pcALCL and MF).|Cochran-Mantel-Haenszel|||Based on a two-sided Χ² test with a significance level of 0.05, and a 10% dropout rate, a sample size of approximately 124 participants was calculated to provide 90% power to detect a 30% improvement in ORR4 in the brentuximab vedotin group.||56.8|27.5|<0.001
71077683|NCT01578499|141664244|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|15.6||||0.0002|TWO_SIDED|95.0|-2.5|33.0||P-value was stratified by baseline disease diagnosis (pcALCL and MF).|Cochran-Mantel-Haenszel|||||33.0|-2.5|0.0002
71117524|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|6.12||||0.229|TWO_SIDED|95.0|-3.76|16.0||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||16.00|-3.76|0.229
70854032|NCT03595618|141195988|SUPERIORITY||Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|2.5||1|TWO_SIDED|95.0|-4.8|5.0||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||5.0|-4.8|1.000
71077684|NCT01578499|141664245|OTHER||Hazard Ratio (HR)|0.378|||<|0.001|TWO_SIDED|95.0|0.247|0.577|||Log Rank||||Hazard ratio brentuximab vedotin/ comparator (methotrexate or bexarotene) with the 95% CI from a stratified Cox regression model with treatment as the explanatory variable and baseline disease diagnosis (MF or pcALCL) as stratification factor.|0.577|0.247|<0.001
70854033|NCT03595618|141195989|SUPERIORITY||Odds Ratio (OR)|1.05|STANDARD_ERROR_OF_MEAN|0.21||0.991|TWO_SIDED|95.0|0.7|1.58||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Logistic Model||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error of log \[estimate\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen.||1.58|0.70|0.991
70854034|NCT03595618|141195989|SUPERIORITY||Odds Ratio (OR)|0.95|STANDARD_ERROR_OF_MEAN|0.21||0.992|TWO_SIDED|95.0|0.64|1.43||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Logistic Model||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error of log \[estimate\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen.||1.43|0.64|0.992
70854035|NCT03595618|141195989|SUPERIORITY||Odds Ratio (OR)|0.82|STANDARD_ERROR_OF_MEAN|0.21||0.653|TWO_SIDED|95.0|0.55|1.23||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Logistic Model||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error of log \[estimate\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen.||1.23|0.55|0.653
70941300|NCT03751280|141382937|OTHER||Comparison of adjusted least square mean|0.12|STANDARD_ERROR_OF_MEAN|0.89|||TWO_SIDED|90.0|-1.4|1.6|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 57||1.6|-1.4|
71077685|NCT01578499|141664246|SUPERIORITY_OR_OTHER_LEGACY||Estimate of difference|-19.0|||<|0.001|TWO_SIDED|95.0|-26.7|-11.4|||ANCOVA|||P-value is calculated using the analysis of covariance (ANCOVA) model controlling for baseline symptom domain score, eastern cooperative oncology group (ECOG) performance status score (=0 and ≥1), and disease diagnosis (pcALCL and MF) between the brentuximab vedotin and comparator (methotrexate or bexarotene) arms.||-11.4|-26.7|<0.001
71077686|NCT00808470|141664266|SUPERIORITY_OR_OTHER|||||||0.58|||||||t-test, 2 sided|||15 minutes after exposure||||0.58
71077687|NCT00808470|141664266|SUPERIORITY_OR_OTHER|||||||0.39|||||||t-test, 2 sided|||1 hour and 15 minutes after exposure||||0.39
71077688|NCT00808470|141664266|SUPERIORITY_OR_OTHER|||||||0.51|||||||t-test, 2 sided|||2 Hours 15 minutes after exposure||||.51
71077689|NCT00808470|141664266|SUPERIORITY_OR_OTHER|||||||0.36|||||||t-test, 2 sided|||3 hours, 15 minutes after exposure||||.36
71077690|NCT00808470|141664266|SUPERIORITY_OR_OTHER|||||||0.86|||||||t-test, 2 sided|||1 day after exposure||||.86
71077691|NCT00808470|141664266|SUPERIORITY_OR_OTHER|||||||0.24|||||||t-test, 2 sided|||1 week after exposure||||.24
71077692|NCT01945294|141664286|SUPERIORITY_OR_OTHER||Difference in SVR12 percentage|-11.4|||||TWO_SIDED|95.0|-23.2|0.4||||||||0.4|-23.2|
71077693|NCT01156051|141664328|SUPERIORITY_OR_OTHER|||||||0.005|||||||ANOVA|||Null hypothesis: no difference in total sleep time (TST) from baseline to termination. ANOVA single measure, two-tailed, Type II analysis was completed using SPSS.||||0.005
71077694|NCT01156051|141664329|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Null hypothesis: no difference in ADHD Rating Scales - IV total scores from baseline to termination. ANOVA single measure, two-tailed, Type II analysis was completed using SPSS.||||<0.001
71117525|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.38|||<|0.001|TWO_SIDED|95.0|59.56|89.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||89.20|59.56|<0.001
71117526|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|70.54|||<|0.001|TWO_SIDED|95.0|55.45|85.64||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.64|55.45|<0.001
71117527|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|73.24|||<|0.001|TWO_SIDED|95.0|58.18|88.3||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||88.30|58.18|<0.001
71117528|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.05|||<|0.001|TWO_SIDED|95.0|52.53|83.57||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.57|52.53|<0.001
71117529|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|6.38||||0.186|TWO_SIDED|95.0|-3.05|15.81||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.81|-3.05|0.186
71077695|NCT01156051|141664330|SUPERIORITY_OR_OTHER|||||||0.392|||||||ANOVA|||Null hypothesis: no difference in latency to persistent sleep (LPS) from baseline to termination. ANOVA single measure, two-tailed, Type II analysis was completed using SPSS.||||0.392
71077696|NCT01156051|141664331|SUPERIORITY_OR_OTHER|||||||0.059|||||||ANOVA|||Null hypothesis: no difference in total sleep time (TST) from baseline to termination. ANOVA single measure, two-tailed, Type II analysis was completed using SPSS.||||0.059
71077697|NCT01483599|141664341|SUPERIORITY_OR_OTHER|||||||0.002|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (less than or equal to (\<=) 90 kilogram (kg), greater than (\>) 90 kg).||||0.002
71077698|NCT01483599|141664341|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
71077699|NCT01483599|141664341|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
71077700|NCT01483599|141664341|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
71077701|NCT01483599|141664341|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
71077702|NCT01483599|141664341|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
71117530|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.97||||0.703|TWO_SIDED|95.0|-8.18|12.12||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.12|-8.18|0.703
71117531|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.06||||0.312|TWO_SIDED|95.0|-4.68|14.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.79|-4.68|0.312
71117532|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.38|||<|0.001|TWO_SIDED|95.0|59.56|89.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||89.20|59.56|<0.001
71117533|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.59|||<|0.001|TWO_SIDED|95.0|56.61|86.57||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.57|56.61|<0.001
71077703|NCT01483599|141664342|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
71077704|NCT01483599|141664342|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
71077705|NCT01483599|141664342|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
71077706|NCT01483599|141664342|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
71077707|NCT01483599|141664342|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
71077708|NCT01483599|141664342|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
71077709|NCT01483599|141664343|SUPERIORITY_OR_OTHER||Difference in Percentage|-24.0|||||TWO_SIDED|95.0|-44.0|-4.0||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||-4.0|-44.0|
71077710|NCT01483599|141664343|SUPERIORITY_OR_OTHER||Difference in Percentage|2.8|||||TWO_SIDED|95.0|-17.9|23.5||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||23.5|-17.9|
71077711|NCT01483599|141664343|SUPERIORITY_OR_OTHER||Difference in Percentage|20.4|||||TWO_SIDED|95.0|1.5|39.3||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||39.3|1.5|
71077712|NCT01483599|141664343|SUPERIORITY_OR_OTHER||Difference in Percentage|27.7|||||TWO_SIDED|95.0|9.8|45.6||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||45.6|9.8|
71077713|NCT01483599|141664343|SUPERIORITY_OR_OTHER||Difference in Percentage|25.4|||||TWO_SIDED|95.0|7.2|43.6||||||||43.6|7.2|
71077714|NCT01483599|141664344|SUPERIORITY_OR_OTHER||Difference in Percentage|-15.4|||||TWO_SIDED|95.0|-37.7|6.9||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||6.9|-37.7|
71117534|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|73.24|||<|0.001|TWO_SIDED|95.0|58.18|88.3||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||88.30|58.18|<0.001
71117535|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.21|||<|0.001|TWO_SIDED|95.0|53.86|84.56||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.56|53.86|<0.001
71117536|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
71117537|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
71117538|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
71117539|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.38|||<|0.001|TWO_SIDED|95.0|59.56|89.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||89.20|59.56|<0.001
71117540|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.59|||<|0.001|TWO_SIDED|95.0|56.61|86.57||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.57|56.61|<0.001
71117541|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|73.24|||<|0.001|TWO_SIDED|95.0|58.18|88.3||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||88.30|58.18|<0.001
71117542|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.21|||<|0.001|TWO_SIDED|95.0|53.86|84.56||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.56|53.86|<0.001
71117543|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
71117544|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
71117545|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
71117546|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
71117547|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
70941301|NCT03751280|141382937|OTHER||Comparison of adjusted least square mean|1.61|STANDARD_ERROR_OF_MEAN|1.071||0.1368|TWO_SIDED|90.0|-0.2|3.4|||t-test, 2 sided|||Day 85||3.4|-0.2|0.1368
70854036|NCT03595618|141195990|SUPERIORITY||Adjusted mean difference|0.03779|STANDARD_ERROR_OF_MEAN|0.02156||0.193|TWO_SIDED|95.0|-0.00448|0.08005||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||0.08005|-0.00448|0.193
70854037|NCT03595618|141195990|SUPERIORITY||Adjusted mean difference|0.0358|STANDARD_ERROR_OF_MEAN|0.02235||0.256|TWO_SIDED|95.0|-0.00801|0.07962||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||0.07962|-0.00801|0.256
70854038|NCT03595618|141195990|SUPERIORITY||Adjusted mean difference|0.03884|STANDARD_ERROR_OF_MEAN|0.02243||0.201|TWO_SIDED|95.0|-0.00514|0.08281||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||0.08281|-0.00514|0.201
70854039|NCT03595618|141195991|SUPERIORITY||Adjusted mean difference|3.12394|STANDARD_ERROR_OF_MEAN|3.13671||0.627|TWO_SIDED|95.0|-3.02464|9.27252||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|ANCOVA||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: Placebo minus GLPG1972 dose regimen using an analysis of covariance (ANCOVA) including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.||9.27252|-3.02464|0.627
70854040|NCT03595618|141195991|SUPERIORITY||Adjusted mean difference|0.46842|STANDARD_ERROR_OF_MEAN|3.21111||0.998|TWO_SIDED|95.0|-5.82659|6.76343||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|ANCOVA||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: Placebo minus GLPG1972 dose regimen using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.||6.76343|-5.82659|0.998
70854041|NCT03595618|141195991|SUPERIORITY||Adjusted mean difference|4.11756|STANDARD_ERROR_OF_MEAN|3.2759||0.449|TWO_SIDED|95.0|-2.30536|10.54049||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|ANCOVA||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: Placebo minus GLPG1972 dose regimen using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.||10.54049|-2.30536|0.449
70854042|NCT03595618|141195992|SUPERIORITY||Adjusted mean difference|2.84781|STANDARD_ERROR_OF_MEAN|3.75674||0.789|TWO_SIDED|95.0|-4.51643|10.21205||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||10.21205|-4.51643|0.789
70854043|NCT03595618|141195992|SUPERIORITY||Adjusted mean difference|-3.64759|STANDARD_ERROR_OF_MEAN|3.84747||0.661|TWO_SIDED|95.0|-11.19071|3.89553||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||3.89553|-11.19071|0.661
71117548|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
71117549|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
71117550|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
71117551|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
71117552|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
71117553|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
71117554|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
71117555|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
71117556|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
71117557|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
70941302|NCT03751280|141382938|OTHER||Comparison of adjusted least square mean|-0.13|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|90.0|-0.8|0.6|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 29||0.6|-0.8|
70941303|NCT03751280|141382938|OTHER||Comparison of adjusted least square mean|0.15|STANDARD_ERROR_OF_MEAN|0.453|||TWO_SIDED|90.0|-0.6|0.9|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 57||0.9|-0.6|
71117558|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
71117559|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
71117560|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
71117561|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
71117562|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
70854044|NCT03595618|141195992|SUPERIORITY||Adjusted mean difference|-2.55176|STANDARD_ERROR_OF_MEAN|3.81987||0.843|TWO_SIDED|95.0|-10.04053|4.93701||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||4.93701|-10.04053|0.843
71117563|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
71117564|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
71117565|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
71117566|NCT01559259|141740587|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
71117567|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|23.99||||0.003|TWO_SIDED|95.0|13.32|34.67||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||34.67|13.32|0.003
71117568|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|14.83||||0.048|TWO_SIDED|95.0|4.59|25.07||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||25.07|4.59|0.048
71117569|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|24.98||||0.005|TWO_SIDED|95.0|13.43|36.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||36.53|13.43|0.005
71117570|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|16.57||||0.03|TWO_SIDED|95.0|6.25|26.88||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||26.88|6.25|0.030
71117571|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|6.86||||0.269|TWO_SIDED|95.0|-4.8|18.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.53|-4.80|0.269
71117572|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-1.95||||0.735|TWO_SIDED|95.0|-13.34|9.43||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.43|-13.34|0.735
71117573|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.58||||0.176|TWO_SIDED|95.0|-3.88|21.04||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||21.04|-3.88|0.176
71117574|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|63.3|||<|0.001|TWO_SIDED|95.0|49.07|77.52||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||77.52|49.07|<0.001
70854045|NCT03595618|141195993|SUPERIORITY||Adjusted mean difference|0.0951|STANDARD_ERROR_OF_MEAN|0.0499||0.141|TWO_SIDED|95.0|-0.0028|0.1929||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|ANCOVA||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.||0.1929|-0.0028|0.141
70854046|NCT03595618|141195993|SUPERIORITY||Adjusted mean difference|0.0158|STANDARD_ERROR_OF_MEAN|0.0519||0.981|TWO_SIDED|95.0|-0.0861|0.1177||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|ANCOVA||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.||0.1177|-0.0861|0.981
71077715|NCT01483599|141664344|SUPERIORITY_OR_OTHER||Difference in Percentage|10.8|||||TWO_SIDED|95.0|-10.7|32.4||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||32.4|-10.7|
71077716|NCT01483599|141664344|SUPERIORITY_OR_OTHER||Difference in Percentage|22.7|||||TWO_SIDED|95.0|1.8|43.6||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||43.6|1.8|
71077717|NCT01483599|141664344|SUPERIORITY_OR_OTHER||Difference in Percentage|28.7|||||TWO_SIDED|95.0|8.5|49.0||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||49.0|8.5|
71077718|NCT01483599|141664344|SUPERIORITY_OR_OTHER||Difference in Percentage|32.9|||||TWO_SIDED|95.0|13.0|52.8||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||52.8|13.0|
71077719|NCT01483599|141664345|SUPERIORITY_OR_OTHER|||||||0.008|||||||ANOVA on the van Der Waerden score|||||||0.008
71077720|NCT01483599|141664345|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on the van Der Waerden score|||||||< 0.001
71077721|NCT01483599|141664345|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on the van Der Waerden score|||||||< 0.001
71077722|NCT01483599|141664345|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on the van Der Waerden score|||||||< 0.001
71077723|NCT01483599|141664345|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on the van Der Waerden score|||||||< 0.001
71077724|NCT01483599|141664345|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on the van Der Waerden score|||||||< 0.001
71077725|NCT01160380|141664346|SUPERIORITY_OR_OTHER|||||||0.289|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment||||0.289
71077726|NCT01160380|141664346|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between Day 1 and Day 28||||<0.001
71077727|NCT01160380|141664346|SUPERIORITY_OR_OTHER||||||<|0.002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between Day 1 and day 28||||<0.002
71077728|NCT01160380|141664346|SUPERIORITY_OR_OTHER|||||||0.449|TWO_SIDED||||||t-test, 2 sided|||Comparison between Day 28 and Day 56 of treatment for the armodafinil arm||||0.449
71077729|NCT01160380|141664347|SUPERIORITY_OR_OTHER|||||||0.954|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment||||0.954
71077730|NCT01160380|141664347|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Placebo-First arm||||0.007
71077731|NCT01160380|141664347|SUPERIORITY_OR_OTHER|||||||0.369|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Armodafinil arm||||0.369
71077732|NCT01160380|141664347|SUPERIORITY_OR_OTHER|||||||0.973|TWO_SIDED||||||t-test, 2 sided|||Comparison between Day 28 and Day 56 of treatment for the Armodafinil arm||||0.973
71077733|NCT01160380|141664348|SUPERIORITY_OR_OTHER|||||||0.699|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms at day 28||||0.699
71077734|NCT01160380|141664348|SUPERIORITY_OR_OTHER|||||||0.984|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm||||0.984
71077735|NCT01160380|141664348|SUPERIORITY_OR_OTHER|||||||0.239|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Armodafinil arm||||0.239
71077736|NCT01160380|141664348|SUPERIORITY_OR_OTHER|||||||0.089|TWO_SIDED||||||t-test, 2 sided|||Day 28 vs. Day 56 of treatment for the Armodafinil arm||||0.089
71077737|NCT01160380|141664349|SUPERIORITY_OR_OTHER|||||||0.636|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment for the Digit Span Test score-Forward test||||0.636
71077738|NCT01160380|141664349|SUPERIORITY_OR_OTHER|||||||0.531|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment for the Digit Span Test score-Backward test||||0.531
71077739|NCT01160380|141664349|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-Digit Span Test score Forward test||||0.037
71077740|NCT01160380|141664349|SUPERIORITY_OR_OTHER|||||||0.656|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-Digit Span Test score Backward test||||0.656
71077741|NCT01160380|141664349|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. day 28 of treatment for the Armodafinil arm-Digit Span Test score-Forward test||||0.028
71077742|NCT01160380|141664349|SUPERIORITY_OR_OTHER|||||||0.805|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. day 28 of treatment for the Armodafinil arm-Digit Span Test score-Backward test||||0.805
71077743|NCT01160380|141664349|SUPERIORITY_OR_OTHER|||||||0.692|TWO_SIDED||||||t-test, 2 sided|||Day 28 vs. day 56 of treatment for the Armodafinil arm-Digit Span Test score-Forward test||||0.692
71077744|NCT01160380|141664349|SUPERIORITY_OR_OTHER|||||||0.863|TWO_SIDED||||||t-test, 2 sided|||Day 28 vs. day 56 of treatment for the Armodafinil arm-Digit Span Test score-Backward test||||0.863
71077745|NCT01160380|141664350|SUPERIORITY_OR_OTHER|||||||0.559|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for Day 28 of treatment- FACIT-F total||||0.559
71077746|NCT01160380|141664350|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm- FACIT-F total||||<0.001
70854047|NCT03595618|141195993|SUPERIORITY||Adjusted mean difference|0.0753|STANDARD_ERROR_OF_MEAN|0.0529||0.349|TWO_SIDED|95.0|-0.0286|0.1792||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|ANCOVA||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.||0.1792|-0.0286|0.349
70854048|NCT01782469|141196021|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Mean percent reduction in ultrasonography assessment score at Vist 2 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||0.001
70854049|NCT01782469|141196021|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Mean percent reduction in ultrasonography assessment score at Vist 3 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||0.001
70854050|NCT01782469|141196021|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Mean percent reduction in ultrasonography assessment score at Vist 4 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||<0.001
70854051|NCT01782469|141196021|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Mean percent reduction in ultrasonography assessment score at Vist 5 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||0.001
70854052|NCT01782469|141196022|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED|||||Mean number of joints with erosions at Vist 2 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||.130
70854053|NCT01782469|141196022|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||Mean number of joints with erosions at Vist 3 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||0.031
70854054|NCT01782469|141196022|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||Mean number of joints with erosions at Vist 4 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||0.006
70854055|NCT01782469|141196022|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||Mean number of joints with erosions at Vist 5 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||0.003
70854056|NCT02614469|141196037|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|103.0|||||TWO_SIDED|90.0|98.0|108.0|||||Fed/Fasting Ratio|To assess the effect of food on the PK of urate, analyses of variance (ANOVA) using a linear mixed-effects model was fitted to the natural logarithmic transformation of PK parameters of urate. The linear mixed-effects model will include subject as a random effect, and treatment, period, and sequence as fixed effects. The 90% confidence intervals were constructed for the ratio of geometric means of PK parameters between fed and fasted treatments, based on log-transformed data.||108|98.0|
70854057|NCT02614469|141196038|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|99.3|||||TWO_SIDED|90.0|96.9|102.0|||||Fed/Fasted Ratio|To assess the effect of food on the PK of urate, analyses of variance (ANOVA) using a linear mixed-effects model was fitted to the natural logarithmic transformation of PK parameters of urate. The linear mixed-effects model will include subject as a random effect, and treatment, period, and sequence as fixed effects. The 90% confidence intervals were constructed for the ratio of geometric means of PK parameters between fed and fasted treatments, based on log-transformed data.||102|96.9|
70854058|NCT02614469|141196042|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|103.0|||||TWO_SIDED|90.0|90.9|118.0|||||Fed/Fasted Ratio|To assess the effect of food on the PK of urate, analyses of variance (ANOVA) using a linear mixed-effects model was fitted to the natural logarithmic transformation of PK parameters of urate. The linear mixed-effects model will include subject as a random effect, and treatment, period, and sequence as fixed effects. The 90% confidence intervals were constructed for the ratio of geometric means of PK parameters between fed and fasted treatments, based on log-transformed data.||118|90.9|
70854059|NCT02614469|141196043|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|83.4|||||TWO_SIDED|90.0|62.1|112.0|||||Fed/Fasted Ratio|To assess the effect of food on the PK of urate, analyses of variance (ANOVA) using a linear mixed-effects model was fitted to the natural logarithmic transformation of PK parameters of urate. The linear mixed-effects model will include subject as a random effect, and treatment, period, and sequence as fixed effects. The 90% confidence intervals were constructed for the ratio of geometric means of PK parameters between fed and fasted treatments, based on log-transformed data.||112|62.1|
70854060|NCT02184572|141196068|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The upper limit of the 2-sided standardised asymptotic 95% Confidence Interval (CI) for the group difference (INV\_MMR minus COM\_MMR) in incidence of fever ≥ 39.0°C (≥ 102.2°F) should be equal to or below 5%.|Difference in incidence of fever|1.11|||||TWO_SIDED|95.0|-0.93|2.89||||||Difference between groups (INV\_MMR Group minus COM\_MMR Group) in incidence of fever \> 39.0°C.||2.89|-0.93|
70854061|NCT02184572|141196068|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The upper limit of the 2-sided standardised asymptotic 95% CI for the group difference (INV\_MMR minus COM\_MMR) in incidence of fever ≥ 38.0°C (≥ 100.4°F) should be equal to or below 10%.|Difference in incidence of fever|1.09|||||TWO_SIDED|95.0|-2.89|4.85||||||Difference between groups (INV\_MMR Group minus COM\_MMR Group) in incidence of fever \> 38.0°C.||4.85|-2.89|
70854062|NCT01328444|141196089|SUPERIORITY_OR_OTHER||Least squares mean difference|26.5||||0.321|TWO_SIDED|95.0|-25.9|78.9||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 62.5 µg minus Placebo.|||78.9|-25.9|0.321
70854063|NCT01328444|141196089|SUPERIORITY_OR_OTHER||Least squares mean difference|13.1||||0.62|TWO_SIDED|95.0|-38.9|65.1||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 125 µg minus Placebo.|||65.1|-38.9|0.620
70854064|NCT01328444|141196089|SUPERIORITY_OR_OTHER||Least squares mean difference|-10.0||||0.665|TWO_SIDED|95.0|-55.5|35.4||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=VI 25 µg minus Placebo.|||35.4|-55.5|0.665
70854065|NCT01328444|141196089|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.6||||0.865|TWO_SIDED|95.0|-57.6|48.4||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus UMEC 62.5 µg.|||48.4|-57.6|0.865
70854066|NCT01328444|141196089|SUPERIORITY_OR_OTHER||Least squares mean difference|31.9||||0.174|TWO_SIDED|95.0|-14.1|77.9||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus VI 25 µg.|||77.9|-14.1|0.174
71077747|NCT01160380|141664350|SUPERIORITY_OR_OTHER|||||||0.192|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Armodafinil arm- FACIT-F total||||0.192
70854067|NCT01328444|141196089|SUPERIORITY_OR_OTHER||Least squares mean difference|19.3||||0.472|TWO_SIDED|95.0|-33.4|71.9||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus UMEC 125 µg.|||71.9|-33.4|0.472
70854068|NCT01328444|141196089|SUPERIORITY_OR_OTHER||Least squares mean difference|42.4||||0.072|TWO_SIDED|95.0|-3.8|88.7||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus VI 25 µg.|||88.7|-3.8|0.072
70854069|NCT01328444|141196089|SUPERIORITY_OR_OTHER||Least squares mean difference|21.9||||0.234|TWO_SIDED|95.0|-14.2|58.0||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||58.0|-14.2|0.234
70854070|NCT01328444|141196089|SUPERIORITY_OR_OTHER||Least squares mean difference|32.4||||0.08|TWO_SIDED|95.0|-3.9|68.8||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus Placebo.|||68.8|-3.9|0.080
70854071|NCT01328444|141196090|SUPERIORITY_OR_OTHER||Least squares mean difference|0.087||||0.003|TWO_SIDED|95.0|0.03|0.143||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 62.5 µg minus Placebo.|||0.143|0.030|0.003
70854072|NCT01328444|141196090|SUPERIORITY_OR_OTHER||Least squares mean difference|0.14|||<|0.001|TWO_SIDED|95.0|0.084|0.196||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 125 µg minus Placebo.|||0.196|0.084|<0.001
70854073|NCT01328444|141196090|SUPERIORITY_OR_OTHER||Least squares mean difference|0.099|||<|0.001|TWO_SIDED|95.0|0.05|0.148||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=VI 25 µg minus Placebo.|||0.148|0.050|<0.001
70854074|NCT01328444|141196090|SUPERIORITY_OR_OTHER||Least squares mean difference|0.124|||<|0.001|TWO_SIDED|95.0|0.067|0.181||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus UMEC 62.5 µg.|||0.181|0.067|<0.001
70854075|NCT01328444|141196090|SUPERIORITY_OR_OTHER||Least squares mean difference|0.111|||<|0.001|TWO_SIDED|95.0|0.062|0.161||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus VI 25 µg.|||0.161|0.062|<0.001
70854076|NCT01328444|141196090|SUPERIORITY_OR_OTHER||Least squares mean difference|0.029||||0.32|TWO_SIDED|95.0|-0.028|0.086||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus UMEC 125 µg.|||0.086|-0.028|0.320
71077748|NCT01160380|141664350|SUPERIORITY_OR_OTHER|||||||0.495|TWO_SIDED||||||t-test, 2 sided|||Day 28 vs. Day 56of treatment for the Armodafinil arm- FACIT-F total||||0.495
71077749|NCT01160380|141664351|SUPERIORITY_OR_OTHER|||||||0.945|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment- HADS anxiety||||0.945
71077750|NCT01160380|141664351|SUPERIORITY_OR_OTHER|||||||0.316|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment- HADS depression||||0.316
71077751|NCT01160380|141664351|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-HADS anxiety||||0.005
71077752|NCT01160380|141664351|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-HADS depression||||0.005
71077753|NCT01160380|141664351|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Armodafinil arm-HADS anxiety||||0.001
71077754|NCT01160380|141664351|SUPERIORITY_OR_OTHER|||||||0.315|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-HADS depression||||0.315
71077755|NCT01160380|141664351|SUPERIORITY_OR_OTHER|||||||0.933|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 28 vs. Day 56 of treatment for the Armodafinil arm-HADS anxiety||||0.933
71077756|NCT01160380|141664351|SUPERIORITY_OR_OTHER|||||||0.378|TWO_SIDED||||||t-test, 2 sided|||Day 28 vs. Day 56 of treatment for the Armodafinil arm-HADS depression||||0.378
71077757|NCT01160380|141664352|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for Day 28 of treatment -ESS||||0.840
71077758|NCT01160380|141664352|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-ESS||||0.050
71077759|NCT01160380|141664352|SUPERIORITY_OR_OTHER|||||||0.051|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 and Day 28 of treatment for the Armodafinil arm- ESS||||0.051
71077760|NCT01160380|141664352|SUPERIORITY_OR_OTHER|||||||0.635|TWO_SIDED||||||t-test, 2 sided|||Day 28 vs. Day 56 of treatment for the Armodafinil arm||||0.635
71077761|NCT03046056|141664370|SUPERIORITY||Risk Difference in Proportions|8.3|||||TWO_SIDED|90.0|-16.5|32.1||||||||32.1|-16.5|
71077762|NCT03046056|141664370|SUPERIORITY||Risk Difference in Proportions|8.3|||||TWO_SIDED|90.0|-15.9|32.0||||||||32.0|-15.9|
71077763|NCT03046056|141664371|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.81|||TWO_SIDED|90.0|-5.3|0.7||||||Difference in least squared means (Diff in LSM), and its 90% confidence interval (CI) were from analysis of covariance (ANCOVA) model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||0.7|-5.3|
71077764|NCT03046056|141664371|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|1.72|||TWO_SIDED|90.0|-2.7|3.1||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||3.1|-2.7|
71077765|NCT03046056|141664372|SUPERIORITY||Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|1.38|||TWO_SIDED|90.0|-3.9|0.7||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||0.7|-3.9|
70854077|NCT01328444|141196090|SUPERIORITY_OR_OTHER||Least squares mean difference|0.07||||0.007|TWO_SIDED|95.0|0.019|0.12||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus VI 25 µg.|||0.120|0.019|0.007
70854078|NCT01328444|141196090|SUPERIORITY_OR_OTHER||Least squares mean difference|0.211|||<|0.001|TWO_SIDED|95.0|0.172|0.249||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||0.249|0.172|<0.001
70854079|NCT01328444|141196090|SUPERIORITY_OR_OTHER||Least squares mean difference|0.169|||<|0.001|TWO_SIDED|95.0|0.129|0.209||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus Placebo.|||0.209|0.129|<0.001
71117575|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|56.81|||<|0.001|TWO_SIDED|95.0|42.28|71.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||71.34|42.28|<0.001
71117576|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|67.57|||<|0.001|TWO_SIDED|95.0|53.58|81.55||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.55|53.58|<0.001
71117577|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|53.31|||<|0.001|TWO_SIDED|95.0|38.62|67.99||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||67.99|38.62|<0.001
71117578|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|10.28||||0.14|TWO_SIDED|95.0|-3.26|23.82||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||23.82|-3.26|0.140
71117579|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.98||||0.674|TWO_SIDED|95.0|-10.94|16.89||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||16.89|-10.94|0.674
71117580|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|14.58||||0.034|TWO_SIDED|95.0|1.22|27.93||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||27.93|1.22|0.034
70854080|NCT00561977|141196148|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Mixed Models Analysis|time measurement, treatment group, interaction between time and group term as fixed effect, subject as random effect.||Mean dietary quality score by visit and study group was estimated using SAS PROC MIXED. All analyses were performed using SAS 9.13 (SAS Institute, Cary, NC, USA).||||0.14
70854081|NCT01755026|141196166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|191.0|STANDARD_ERROR_OF_MEAN|166.01|<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.01
70854082|NCT00392379|141196167|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.0|STANDARD_DEVIATION|43.0|<|0.05|TWO_SIDED|95.0||||No adjustment for multiple comparisons.|Regression, Logistic|||Based upon previous research, we hypothesized that the end-of-treatment abstinence rate for subjects receiving placebo would be 35% and the abstinence rate for subjects receiving the 4-mg nicotine lozenge would be 53%. A resulting power calculation indicated that 270 subjects (135 per group) were required in order to have 85% power to detect a significant difference (two-sided, α = 0.05 level test).||||<0.05
71077766|NCT03046056|141664372|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|-3.2|1.2||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||1.2|-3.2|
71077767|NCT03046056|141664373|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.24|||TWO_SIDED|90.0|-2.2|2.0||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||2.0|-2.2|
71117581|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|72.32|||<|0.001|TWO_SIDED|95.0|58.25|86.39||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.39|58.25|<0.001
70854083|NCT03645434|141196191|SUPERIORITY||Mean Difference (Final Values)|0.202|||<|0.0001|TWO_SIDED|95.0|0.151|0.253|||Mixed Models Analysis|||||0.253|0.151|<0.0001
70854084|NCT03645434|141196196|SUPERIORITY||Mean Difference (Final Values)|0.098|||<|0.0001|TWO_SIDED|95.0|0.051|0.146|||Mixed Models Analysis|||Day 2||0.146|0.051|<0.0001
70854085|NCT03645434|141196196|SUPERIORITY||Mean Difference (Final Values)|0.195|||<|0.0001|TWO_SIDED|95.0|0.148|0.242|||Mixed Models Analysis|||Day 8||0.242|0.148|<0.0001
70854086|NCT03645434|141196197|SUPERIORITY||Mean Difference (Final Values)|0.306|||<|0.0001|TWO_SIDED|95.0|0.266|0.346|||Mixed Models Analysis|||Day 1||0.346|0.266|<0.0001
71077768|NCT03046056|141664373|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|90.0|-1.9|2.0||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||2.0|-1.9|
71077769|NCT03046056|141664374|SUPERIORITY||Risk Difference in Proportions|-1.7|||||TWO_SIDED|90.0|-28.6|25.5||||||||25.5|-28.6|
71077770|NCT03046056|141664374|SUPERIORITY||Risk Difference in Proportions|0.4|||||TWO_SIDED|90.0|-24.5|26.2||||||||26.2|-24.5|
71077771|NCT03046056|141664375|SUPERIORITY||Risk Difference in Proportions|-6.7|||||TWO_SIDED|90.0|-47.3|37.0||||||||37.0|-47.3|
71077772|NCT03046056|141664375|SUPERIORITY||Risk Difference in Proportions|-16.7|||||TWO_SIDED|90.0|-58.2|30.0||||||||30.0|-58.2|
71077773|NCT03046056|141664376|SUPERIORITY||Risk Difference in Proportions|33.3|||||TWO_SIDED|90.0|-32.4|86.5||||||||86.5|-32.4|
71077774|NCT03046056|141664377|SUPERIORITY||Risk Difference in Proportions|-2.3|||||TWO_SIDED|90.0|-28.6|24.3||||||||24.3|-28.6|
71077775|NCT03046056|141664377|SUPERIORITY||Risk Difference in Proportions|-15.0|||||TWO_SIDED|90.0|-39.4|11.3||||||||11.3|-39.4|
71077776|NCT03046056|141664378|SUPERIORITY||Risk Difference in Proportions|3.3|||||TWO_SIDED|90.0|-38.9|45.7||||||||45.7|-38.9|
71077777|NCT03046056|141664378|SUPERIORITY||Risk Difference in Proportions|-4.2|||||TWO_SIDED|90.0|-47.5|40.8||||||||40.8|-47.5|
71077778|NCT03046056|141664379|SUPERIORITY||Risk Difference in Proportions|50.0|||||TWO_SIDED|90.0|-16.8|89.5||||||||89.5|-16.8|
71077779|NCT03046056|141664379|SUPERIORITY||Risk Difference in Proportions|12.5|||||TWO_SIDED|90.0|-46.1|63.3||||||||63.3|-46.1|
71077780|NCT03046056|141664380|SUPERIORITY||Risk Difference in Proportions|8.0|||||TWO_SIDED|90.0|-17.2|32.6||||||||32.6|-17.2|
71077781|NCT03046056|141664380|SUPERIORITY||Risk Difference in Proportions|6.3|||||TWO_SIDED|90.0|-18.1|30.2||||||||30.2|-18.1|
71077782|NCT03046056|141664381|SUPERIORITY||Risk Difference in Proportions|3.3|||||TWO_SIDED|90.0|-22.1|28.1||||||||28.1|-22.1|
71077783|NCT03046056|141664381|SUPERIORITY||Risk Difference in Proportions|-4.2|||||TWO_SIDED|90.0|-28.1|20.3||||||||20.3|-28.1|
71077784|NCT03046056|141664382|SUPERIORITY||Risk Difference in Proportions|17.1|||||TWO_SIDED|90.0|-7.6|40.4||||||||40.4|-7.6|
71077785|NCT03046056|141664382|SUPERIORITY||Risk Difference in Proportions|2.8|||||TWO_SIDED|90.0|-21.2|26.5||||||||26.5|-21.2|
71077786|NCT03046056|141664383|SUPERIORITY||Least Squares Mean Difference|-48.0|STANDARD_ERROR_OF_MEAN|28.1|||TWO_SIDED|90.0|-95.0|-1.0||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||-1|-95|
71077787|NCT03046056|141664383|SUPERIORITY||Least Squares Mean Difference|-31.0|STANDARD_ERROR_OF_MEAN|27.4|||TWO_SIDED|90.0|-76.0|15.0||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||15|-76|
71077788|NCT03046056|141664384|SUPERIORITY||Least Squares Mean Difference|-20.0|STANDARD_ERROR_OF_MEAN|28.7|||TWO_SIDED|90.0|-68.0|28.0||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||28|-68|
71077789|NCT03046056|141664384|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|28.0|||TWO_SIDED|90.0|-52.0|42.0||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||42|-52|
71077790|NCT02913105|141664386|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (Body Mass Index (BMI) group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.97||||0.7489|TWO_SIDED|90.0|0.83|1.13|||ANCOVA|An unstructured variance-covariance structure was used.||||1.13|0.83|0.7489
71077791|NCT02913105|141664386|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.72||||0.0005|TWO_SIDED|90.0|0.62|0.84|||ANCOVA|An unstructured variance-covariance structure was used.||||0.84|0.62|0.0005
71077792|NCT02913105|141664386|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.74||||0.0005|TWO_SIDED|90.0|0.65|0.85|||ANCOVA|An unstructured variance-covariance structure was used.||||0.85|0.65|0.0005
71077793|NCT02913105|141664391|OTHER|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|0.95||||0.5354|TWO_SIDED|90.0|0.83|1.09|||ANCOVA|||||1.09|0.83|0.5354
71077794|NCT02913105|141664391|SUPERIORITY|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|0.68|||<|0.0001|TWO_SIDED|90.0|0.59|0.78|||ANCOVA|||||0.78|0.59|<.0001
71077795|NCT02913105|141664391|SUPERIORITY|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|0.71|||<|0.0001|TWO_SIDED|90.0|0.63|0.8|||ANCOVA|||||0.80|0.63|<.0001
70854087|NCT03645434|141196197|SUPERIORITY||Mean Difference (Final Values)|0.374|||<|0.0001|TWO_SIDED|95.0|0.324|0.425|||Mixed Models Analysis|||Day 8||0.425|0.324|<0.0001
71117582|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|67.2|||<|0.001|TWO_SIDED|95.0|52.63|81.78||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.78|52.63|<0.001
70854088|NCT03645434|141196197|SUPERIORITY||Mean Difference (Final Values)|0.388|||<|0.0001|TWO_SIDED|95.0|0.329|0.447|||Mixed Models Analysis|||Day 14||0.447|0.329|<0.0001
70854089|NCT03645434|141196198|SUPERIORITY||Mean Difference (Final Values)|-0.551||||0.001|TWO_SIDED|95.0|-0.876|-0.226|||Mixed Models Analysis|||Day 1 to Day 8||-0.226|-0.876|0.0010
71077796|NCT02913105|141664392|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.079|STANDARD_ERROR_OF_MEAN|0.389||0.8402|TWO_SIDED|90.0|-0.724|0.567|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.567|-0.724|0.8402
71077797|NCT02913105|141664392|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.144|STANDARD_ERROR_OF_MEAN|0.472||0.7607|TWO_SIDED|90.0|-0.927|0.639|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||0.639|-0.927|0.7607
71077798|NCT02913105|141664392|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.228|STANDARD_ERROR_OF_MEAN|0.487||0.6406|TWO_SIDED|90.0|-1.037|0.581|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||0.581|-1.037|0.6406
71077799|NCT02913105|141664392|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.158|STANDARD_ERROR_OF_MEAN|0.685||0.8185|TWO_SIDED|90.0|-1.294|0.979|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||0.979|-1.294|0.8185
71077800|NCT02913105|141664392|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.214|STANDARD_ERROR_OF_MEAN|0.766||0.7804|TWO_SIDED|90.0|-1.485|1.057|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||1.057|-1.485|0.7804
71077801|NCT02913105|141664392|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.598|STANDARD_ERROR_OF_MEAN|0.402||0.1403|TWO_SIDED|90.0|-1.265|0.07|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.070|-1.265|0.1403
71077802|NCT02913105|141664392|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.49||0.0603|TWO_SIDED|90.0|-1.743|-0.117|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||-0.117|-1.743|0.0603
71077803|NCT02913105|141664392|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-1.344|STANDARD_ERROR_OF_MEAN|0.505||0.009|TWO_SIDED|90.0|-2.182|-0.506|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||-0.506|-2.182|0.0090
71077804|NCT02913105|141664392|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-1.787|STANDARD_ERROR_OF_MEAN|0.71||0.0134|TWO_SIDED|90.0|-2.965|-0.609|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||-0.609|-2.965|0.0134
71077805|NCT02913105|141664392|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-2.123|STANDARD_ERROR_OF_MEAN|0.793||0.0087|TWO_SIDED|90.0|-3.439|-0.807|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||-0.807|-3.439|0.0087
70854090|NCT03645434|141196198|SUPERIORITY||Mean Difference (Final Values)|-0.867|||<|0.0001|TWO_SIDED|95.0|-1.248|-0.486|||Mixed Models Analysis|||Day 9 to Day 14||-0.486|-1.248|<0.0001
70854091|NCT03645434|141196198|SUPERIORITY||Mean Difference (Final Values)|-0.722|||<|0.0001|TWO_SIDED|95.0|-1.047|-0.397|||Mixed Models Analysis|||Day 1 to Day 14||-0.397|-1.047|<0.0001
70854092|NCT03645434|141196199|SUPERIORITY||Mean Difference (Final Values)|-1.571||||0.0022|TWO_SIDED|95.0|-2.563|-0.579|||Mixed Models Analysis|||Day 1 to Day 8||-0.579|-2.563|0.0022
71077806|NCT02913105|141664392|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.519|STANDARD_ERROR_OF_MEAN|0.368||0.1609|TWO_SIDED|90.0|-1.13|0.091|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.091|-1.130|0.1609
71077807|NCT02913105|141664392|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.786|STANDARD_ERROR_OF_MEAN|0.444||0.0797|TWO_SIDED|90.0|-1.524|-0.049|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||-0.049|-1.524|0.0797
71077808|NCT02913105|141664392|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-1.116|STANDARD_ERROR_OF_MEAN|0.455||0.0159|TWO_SIDED|90.0|-1.872|-0.36|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||-0.360|-1.872|0.0159
71077809|NCT02913105|141664392|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-1.63|STANDARD_ERROR_OF_MEAN|0.635||0.0118|TWO_SIDED|90.0|-2.684|-0.575|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||-0.575|-2.684|0.0118
71077810|NCT02913105|141664392|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-1.909|STANDARD_ERROR_OF_MEAN|0.7||0.0076|TWO_SIDED|90.0|-3.072|-0.746|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||-0.746|-3.072|0.0076
71077811|NCT02913105|141664393|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.033|STANDARD_ERROR_OF_MEAN|0.137||0.8127|TWO_SIDED|90.0|-0.26|0.195|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.195|-0.260|0.8127
71077812|NCT02913105|141664393|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.166||0.8901|TWO_SIDED|90.0|-0.298|0.252|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||0.252|-0.298|0.8901
71077813|NCT02913105|141664393|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.088|STANDARD_ERROR_OF_MEAN|0.177||0.6209|TWO_SIDED|90.0|-0.381|0.205|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||0.205|-0.381|0.6209
71077814|NCT02913105|141664393|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.048|STANDARD_ERROR_OF_MEAN|0.238||0.8398|TWO_SIDED|90.0|-0.444|0.347|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||0.347|-0.444|0.8398
71077815|NCT02913105|141664393|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.073|STANDARD_ERROR_OF_MEAN|0.266||0.7839|TWO_SIDED|90.0|-0.515|0.369|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||0.369|-0.515|0.7839
71077816|NCT02913105|141664393|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.241|STANDARD_ERROR_OF_MEAN|0.141||0.0911|TWO_SIDED|90.0|-0.476|-0.006|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||-0.006|-0.476|0.0911
71077817|NCT02913105|141664393|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.338|STANDARD_ERROR_OF_MEAN|0.172||0.052|TWO_SIDED|90.0|-0.623|-0.053|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||-0.053|-0.623|0.0520
71077818|NCT02913105|141664393|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.183||0.0085|TWO_SIDED|90.0|-0.793|-0.187|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||-0.187|-0.793|0.0085
71077819|NCT02913105|141664393|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.657|STANDARD_ERROR_OF_MEAN|0.247||0.0091|TWO_SIDED|90.0|-1.067|-0.247|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||-0.247|-1.067|0.0091
71079462|NCT00482170|141666445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.376|TWO_SIDED|95.0|0.79|1.85||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.85|0.79|0.376
71079463|NCT00482170|141666445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.299|TWO_SIDED|95.0|0.83|1.86||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.86|0.83|0.299
71079464|NCT00482170|141666446|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.494|TWO_SIDED|95.0|0.6|1.28||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.28|0.60|0.494
71079465|NCT00482170|141666446|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.036|TWO_SIDED|95.0|0.44|0.97||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.97|0.44|0.036
70854093|NCT03645434|141196199|SUPERIORITY||Mean Difference (Final Values)|-2.386|||<|0.0001|TWO_SIDED|95.0|-3.541|-1.23|||Mixed Models Analysis|||Day 9 to Day 14||-1.230|-3.541|<0.0001
70854094|NCT03645434|141196199|SUPERIORITY||Mean Difference (Final Values)|-1.912||||0.0003|TWO_SIDED|95.0|-2.923|-0.901|||Mixed Models Analysis|||Day 1 to Day 14||-0.901|-2.923|0.0003
70854095|NCT03645434|141196210|SUPERIORITY||Mean Difference (Final Values)|-1.268|||<|0.0001|TWO_SIDED|95.0|-1.741|-0.794|||Mixed Models Analysis|||Day 1 to Day 8||-0.794|-1.741|<0.0001
71077820|NCT02913105|141664393|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.759|STANDARD_ERROR_OF_MEAN|0.275||0.007|TWO_SIDED|90.0|-1.216|-0.302|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||-0.302|-1.216|0.0070
71077821|NCT02913105|141664393|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.208|STANDARD_ERROR_OF_MEAN|0.129||0.1092|TWO_SIDED|90.0|-0.423|0.006|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.006|-0.423|0.1092
71077822|NCT02913105|141664393|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.315|STANDARD_ERROR_OF_MEAN|0.156||0.0457|TWO_SIDED|90.0|-0.574|-0.056|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||-0.056|-0.574|0.0457
71077823|NCT02913105|141664393|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.402|STANDARD_ERROR_OF_MEAN|0.165||0.0162|TWO_SIDED|90.0|-0.676|-0.129|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||-0.129|-0.676|0.0162
70854096|NCT03645434|141196210|SUPERIORITY||Mean Difference (Final Values)|-1.302|||<|0.0001|TWO_SIDED|95.0|-1.804|-0.8|||Mixed Models Analysis|||Day 9 to Day 14||-0.800|-1.804|<0.0001
71077824|NCT02913105|141664393|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.608|STANDARD_ERROR_OF_MEAN|0.221||0.007|TWO_SIDED|90.0|-0.975|-0.242|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||-0.242|-0.975|0.0070
71077825|NCT02913105|141664393|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.686|STANDARD_ERROR_OF_MEAN|0.244||0.006|TWO_SIDED|90.0|-1.091|-0.281|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||-0.281|-1.091|0.0060
71077826|NCT02913105|141664394|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.009||0.9927|TWO_SIDED|90.0|-0.015|0.014|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.014|-0.015|0.9927
71077827|NCT02913105|141664394|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.013||0.2794|TWO_SIDED|90.0|-0.007|0.035|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||0.035|-0.007|0.2794
71077828|NCT02913105|141664394|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.007||0.9032|TWO_SIDED|90.0|-0.012|0.013|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||0.013|-0.012|0.9032
71077829|NCT02913105|141664394|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.009|STANDARD_ERROR_OF_MEAN|0.011||0.4163|TWO_SIDED|90.0|-0.009|0.027|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||0.027|-0.009|0.4163
70854097|NCT00833664|141196211|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|98.2||||||90.0|88.1|109.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109.5|88.1|
70854098|NCT00833664|141196212|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|107.6||||||90.0|104.7|110.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||110.6|104.7|
70854099|NCT00833664|141196213|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|98.2||||||90.0|92.7|104.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.0|92.7|
70854100|NCT00678743|141196214|SUPERIORITY|All statistical significance were completed at the 5% level, two-tailed. Comparability of baseline characteristics between those who did and did not opt to enter the extension study was assessed with the chi square test and analysis of variance.||||||0.0008||||||Threshold for statistical significance p\<0.05|ANOVA|||||||0.0008
70854101|NCT01330017|141196218|SUPERIORITY_OR_OTHER|||||||0.4912||95.0||||The p-value reflects mean change from baseline vs. placebo from an ANCOVA model with adjustments for baseline reflective score value, investigative site, age, and gender.|ANCOVA|||||||0.4912
70854102|NCT01330017|141196218|SUPERIORITY_OR_OTHER|||||||0.4519||95.0||||The p-value reflects mean change from baseline vs. placebo from an ANCOVA model with adjustments for baseline reflective score value, investigative site, age, and gender.|ANCOVA|||||||0.4519
70941304|NCT03751280|141382938|OTHER||Comparison of adjusted least square mean|0.51|STANDARD_ERROR_OF_MEAN|0.581||0.3798|TWO_SIDED|90.0|-0.5|1.5|||t-test, 2 sided||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|||1.5|-0.5|0.3798
70941305|NCT03751280|141382939|OTHER||Comparison of adjusted least square mean|-0.79|STANDARD_ERROR_OF_MEAN|-0.79|||TWO_SIDED|90.0|-3.2|1.6|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 29||1.6|-3.2|
70941306|NCT03751280|141382939|OTHER||Comparison of adjusted least square mean|-1.6|STANDARD_ERROR_OF_MEAN|2.006|||TWO_SIDED|90.0|-4.9|1.7|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 57||1.7|-4.9|
70854103|NCT01330017|141196218|SUPERIORITY_OR_OTHER|||||||0.2186||95.0||||The p-value reflects mean change from baseline vs. placebo from an ANCOVA model with adjustments for baseline reflective score value, investigative site, age, and gender.|ANCOVA|||||||0.2186
70854104|NCT01330017|141196218|SUPERIORITY_OR_OTHER|||||||0.5983||95.0||||The p-value reflects mean change from baseline vs. placebo from an ANCOVA model with adjustments for baseline reflective score value, investigative site, age, and gender.|ANCOVA|||||||0.5983
70854105|NCT01106092|141196226|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The upper limit (UL) of the standardized asymptotic 95% confidence interval (CI) on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 1\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 1 is ≥ 2.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-4.78|4.72||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 1) compared to Poliorix™ vaccine co-administered with Zilbrix™/Hib vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 1 antibodies, one month after vaccination.||4.72|-4.78|
70941307|NCT03751280|141382939|OTHER||Comparison of adjusted least square mean|-4.07|STANDARD_ERROR_OF_MEAN|1.78||0.0245|TWO_SIDED|90.0|-7.0|-1.1|||t-test, 2 sided||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 85||-1.1|-7.0|0.0245
70941308|NCT03751280|141382940|OTHER||Comparison of adjusted least square mean|-0.18|STANDARD_ERROR_OF_MEAN|0.516|||TWO_SIDED|90.0|-1.0|0.7|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 29-Domain 1||0.7|-1.0|
71117583|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|72.4|||<|0.001|TWO_SIDED|95.0|58.4|86.4||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.40|58.40|<0.001
71117584|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|64.12|||<|0.001|TWO_SIDED|95.0|49.32|78.91||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||78.91|49.32|<0.001
71117585|NCT01559259|141740588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.4||||0.119|TWO_SIDED|95.0|-2.06|18.85||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.85|-2.06|0.119
70941309|NCT00024102|141383003|NON_INFERIORITY_OR_EQUIVALENCE|The primary measure of efficacy was the hazard ratio for disease recurrence or death in the capecitabine group as compared with the standard chemotherapy group. Capecitabine would be considered noninferior to standard chemotherapy if the hazard ratio was greater than 0.8046. (With the use of a 5-year landmark for descriptive purposes, this ratio corresponds to a 5-year rate of relapse-free survival of 60% for standard chemotherapy and 53% for capecitabine.)|Hazard Ratio (HR)|2.09|||<|0.001|TWO_SIDED|95.0|1.38|3.17||Multivariate proportional hazards regression used to test for an arm effect was adjusted for tumor size, number of lymph nodes and hormone-receptor status. A priori formal monitoring for futility and noninferiority was planned at accrual milestones|Regression, Cox|||||3.17|1.38|<0.001
70941310|NCT00024102|141383004|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.85||||0.02|TWO_SIDED|95.0|1.11|3.08||Multivariate proportional hazards regression used to test for an arm effect was adjusted for tumor size, number of lymph nodes and hormone-receptor status. There is no adjustment for multiple comparisons.|Regression, Cox|||||3.08|1.11|0.02
70941311|NCT04281875|141383036|SUPERIORITY|||||||0.6905|||||||t-test, 2 sided|||||||0.6905
70854106|NCT01106092|141196226|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 2\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 1 is ≥ 2.|Difference in seroprotection rate|1.28|||||TWO_SIDED|95.0|-3.53|6.94||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 2) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 1 antibodies, one month after vaccination.||6.94|-3.53|
70854107|NCT01106092|141196226|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 3\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 1 is ≥ 2.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-4.78|4.72||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 3) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 1 antibodies, one month after vaccination.||4.72|-4.78|
70854108|NCT01106092|141196226|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 1\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 2 is ≥ 2.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-4.78|4.78||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 1) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 2 antibodies, one month after vaccination.||4.78|-4.78|
70854109|NCT01106092|141196226|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 2\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 2 is ≥ 2.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-4.78|4.72||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 2) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 2 antibodies, one month after vaccination.||4.72|-4.78|
71077830|NCT02913105|141664394|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.011||0.7001|TWO_SIDED|90.0|-0.022|0.014|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||0.014|-0.022|0.7001
71077831|NCT02913105|141664394|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.009||0.5367|TWO_SIDED|90.0|-0.009|0.021|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.021|-0.009|0.5367
70854110|NCT01106092|141196226|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 3\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 2 is ≥ 2.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-4.78|4.72||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 3) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 2 antibodies, one month after vaccination.||4.72|-4.78|
70854111|NCT01106092|141196226|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 1\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 3 is ≥ 2.|Difference in seroprotection rate|1.28|||||TWO_SIDED|95.0|-3.53|6.94||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 1) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 3 antibodies, one month after vaccination.||6.94|-3.53|
70854112|NCT01106092|141196226|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 2\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 3 is ≥ 2.|Difference in seroprotection rate|1.28|||||TWO_SIDED|95.0|-3.53|6.94||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 2) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 3 antibodies, one month after vaccination.||6.94|-3.53|
70941312|NCT00577096|141383054|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis was that there would be no difference between groups for the number of RBC transfusions.||||<0.025
70941313|NCT00577096|141383055|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis is that there was no difference in the number of RBC tranfusions in the exercise versus usual care groups. Data was combined from the short and long term RBC transfusions.||||<0.025
70941314|NCT00577096|141383056|NON_INFERIORITY_OR_EQUIVALENCE|T-test and chi-squared test to check for equivalence of groups for age, race and gender.|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|Analysis included short and long term participants.||||||<0.025
70941315|NCT00577096|141383057|NON_INFERIORITY_OR_EQUIVALENCE|T-test and chi-squared to check for equivalence of groups for age, race and gender.|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis was that there would be no difference between groups for the number of platelet transfusions.||||<0.025
71077832|NCT02913105|141664394|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.013||0.5496|TWO_SIDED|90.0|-0.014|0.03|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||0.030|-0.014|0.5496
70941316|NCT00577096|141383058|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||||||<0.025
71077833|NCT02913105|141664394|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.003|STANDARD_ERROR_OF_MEAN|0.008||0.6844|TWO_SIDED|90.0|-0.01|0.016|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||0.016|-0.010|0.6844
71077834|NCT02913105|141664394|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.011||0.5695|TWO_SIDED|90.0|-0.025|0.012|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||0.012|-0.025|0.5695
71077835|NCT02913105|141664394|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.011||0.8015|TWO_SIDED|90.0|-0.021|0.016|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||0.016|-0.021|0.8015
71077836|NCT02913105|141664394|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.008||0.4923|TWO_SIDED|90.0|-0.008|0.02|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.020|-0.008|0.4923
71077837|NCT02913105|141664394|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.012||0.62|TWO_SIDED|90.0|-0.025|0.014|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||0.014|-0.025|0.6200
71077838|NCT02913105|141664394|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.007||0.7423|TWO_SIDED|90.0|-0.009|0.014|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||0.014|-0.009|0.7423
71077839|NCT02913105|141664394|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.016|STANDARD_ERROR_OF_MEAN|0.01||0.1272|TWO_SIDED|90.0|-0.032|0.001|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||0.001|-0.032|0.1272
71077840|NCT02913105|141664394|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.01||0.8883|TWO_SIDED|90.0|-0.015|0.017|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||0.017|-0.015|0.8883
70941317|NCT00577096|141383059|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis was that there would be no difference between groups for the number of stem cell collection attempts.||||<0.025
70854125|NCT00917644|141196374|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCinf and Cmax fell wholly within (80%, 125%)|Ratio of adjusted geometric means|98.79||||||90.0|94.57|103.2|||ANOVA|Values have been back-transformed from the log scale.|Parameter estimate = ratio (%) (test/reference) of adjusted geometric means. AUClast + (Clast\*/kel), where Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.|Natural log transformed AUCinf was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Adjusted mean difference (Test-Ref) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL \<=µT - µR \<=θU); null hypothesis of inequivalence: (Ho: µT - µR \<θL or µT - µR \>θU).||103.20|94.57|
70854126|NCT00917644|141196376|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCinf and Cmax fell wholly within (80%, 125%). AUCinf method of determination includes AUClast calculated value.|Ratio of adjusted geometric means|98.72||||||90.0|94.41|103.23|||ANOVA|Values have been back-transformed from the log scale.|Parameter estimate = ratio (%) (test/reference) of adjusted geometric means. Log-linear trapezoidal method.|Natural log transformed AUClast was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence interval was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean (Test/Reference) and 90% confidence interval for the ratio.||103.23|94.41|
70854127|NCT00917644|141196377|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCinf and Cmax fell wholly within (80%, 125%)|Ratio of adjusted geometric means|104.66||||||90.0|95.73|114.42|||ANOVA|Values have been back-transformed from the log scale.|Parameter estimate = ratio (%) (test/reference) of adjusted geometric means. Observed directly from data.|Natural log transformed Cmax was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals were obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean (Test/Reference) and 90% confidence interval for the ratio.||114.42|95.73|
70854128|NCT00864916|141196384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.52|||||||Regression, Linear|||||||0.52
70854129|NCT01087736|141196396|SUPERIORITY_OR_OTHER||Incidence Rate Ratio (IRR)|0.89||||0.019|TWO_SIDED|95.0|0.89|0.98||We tested our Primary hypothesis with a random-intercept repeated subject negative binomial model, modeling week (baseline - week 12) as a continuous variable. All analyses were intent-to-treat and used all observations from all weeks.|negative binomial regression|||Our primary protocol-defined analysis was to examine the within-group efficacy of topiramate to reduce percent drinking days (%DD).||0.98|0.89|0.019
70854130|NCT01087736|141196396|SUPERIORITY_OR_OTHER|||||||0|||||||Other|||There were no pre hoc hypothesis regarding change within placebo group. We were only tested change within the topiramate condition.||||0.00
70854131|NCT01087736|141196396|SUPERIORITY_OR_OTHER||Incidence Rate Ratio (IRR)|0.38||||0.036|TWO_SIDED|95.0|0.15|0.94|||Negative binomial model|||"A secondary analysis was powered to detect a Signal or statistical trend (p\<0.10) for a difference between the topiramate and placebo condition. We compared percent drinking days per week between groups averaged over the active phase of the trial (weeks 1-12). The negative binomial model included fixed effect for week, treatment group, and the interaction between treatment group and week. We covaried for baseline %DD averages to control for prestudy and study enrollment effects."||0.94|0.15|0.036
70854132|NCT01087736|141196397|SUPERIORITY_OR_OTHER||||||<|0.026|||||||Mixed Models Analysis|||We planned to explore the efficacy of topiramate in reducing PTSD symptom severity. We used random-intercept linear mixed models to explore the efficacy for topiramate related reduction in PTSD symptomatology. We looked for an effect of week within TOP. Baseline scores for PTSD symptoms were used as covariates in group comparisons. All analyses were intent-to-treat and used all observations from all weeks.||||<0.026
70854133|NCT01087736|141196397|SUPERIORITY_OR_OTHER|||||||0|||||||Other|||There was not a pre hoc hypothesis regarding change within placebo group. We only examined within group change in the topiramate condition.||||0.00
70854134|NCT01323855|141196403|NON_INFERIORITY_OR_EQUIVALENCE|Geometric Mean Ratio (GMR) is contained within the interval \[0.50, 2.00\]|GMR|1.19|||||TWO_SIDED|90.0|0.54|2.62|||||Severe CRI/Healthy|||2.62|0.54|
70854135|NCT01323855|141196404|NON_INFERIORITY_OR_EQUIVALENCE|GMR is contained within the interval \[0.50, 2.00\]|GMR|1.3|||||TWO_SIDED|90.0|0.59|2.87|||||Moderate CRI/Healthy|||2.87|0.59|
70854136|NCT01323855|141196405|NON_INFERIORITY_OR_EQUIVALENCE|GMR is contained within the interval \[0.50, 2.00\]|GMR|2.63|||||TWO_SIDED|90.0|1.38|5.04|||||Mild CRI/Healthy|||5.04|1.38|
70854137|NCT01101308|141196425|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|102.0|||||TWO_SIDED|90.0|97.51|107.27|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||107.27|97.51|
70854138|NCT01101308|141196426|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|100.0|||||TWO_SIDED|90.0|97.19|103.0|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||103.00|97.19|
70854139|NCT01101308|141196427|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|100.0|||||TWO_SIDED|90.0|97.14|102.99|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||102.99|97.14|
70854140|NCT01054183|141196495|NON_INFERIORITY_OR_EQUIVALENCE|powered for 62 patients||||||0.57||95.0|||||z test, two-sided|||Null hypothesis: the proportion of successful 1st intubation attempt is the same for both groups||||0.57
70854141|NCT01054183|141196496|NON_INFERIORITY_OR_EQUIVALENCE|powered for 62 patients||||||0.002||95.0|||||z test, two-sided|||Null hypothesis: overall successful intubation rate is the same for both groups.||||0.002
70854142|NCT02112045|141196500|SUPERIORITY|||||||0.43|||||||Log Rank|||||||0.43
70854143|NCT02112045|141196501|SUPERIORITY|||||||0.6|||||||Log Rank|||||||0.60
70854144|NCT02775240|141196504|OTHER||Ratio of geometric means|1.248|||||TWO_SIDED|90.0|1.13|1.378|||Linear mixed effects model||Log-transformed Cmax values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for Cmax of Digoxin||1.378|1.130|
70854145|NCT02775240|141196505|OTHER||Ratio of geometric means|0.944|||||TWO_SIDED|90.0|0.778|1.144|||Linear mixed effects model|||Comparison of Treatment B over Treatment A for Cmax of Dextromethorphan||1.144|0.778|
70854146|NCT02775240|141196506|OTHER||Ratio of geometric means|0.943|||||TWO_SIDED|90.0|0.883|1.007|||Linear mixed effects model||Log-transformed Cmax values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for Cmax of Dextrorphan||1.007|0.883|
70854147|NCT02775240|141196512|OTHER||Ratio of geometric means|1.206|||||TWO_SIDED|90.0|1.099|1.324|||Linear mixed effects model||Log-transformed AUC0-infinity values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for AUC0-infinity of Digoxin||1.324|1.099|
70854148|NCT02775240|141196514|OTHER||Ratio of geometric means|0.971|||||TWO_SIDED|90.0|0.943|0.999|||Linear mixed effects model||Log-transformed AUC0-infinity values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for AUC0-infinity of Dextrorphan||0.999|0.943|
70854149|NCT02775240|141196515|OTHER||Ratio of geometric means|1.179|||||TWO_SIDED|90.0|1.08|1.287|||Linear mixed effects model||Log-transformed AUClast values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for AUClast for Digoxin||1.287|1.080|
70854150|NCT02775240|141196516|OTHER||Ratio of geometric means|0.882|||||TWO_SIDED|90.0|0.696|1.118|||Linear mixed effects model||Log-transformed AUClast values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for AUClast of Dextromethorphan||1.118|0.696|
70854151|NCT02775240|141196517|OTHER||Ratio of geometric means|0.973|||||TWO_SIDED|90.0|0.949|0.998|||Linear mixed effects model||Log-transformed AUClast values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for AUClast for Dextrorphan||0.998|0.949|
70854152|NCT02775240|141196518|OTHER||Ratio of geometric means|0.905|||||TWO_SIDED|90.0|0.721|1.138|||Linear mixed effects model||Log-transformed AUClast ratio values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for Dextromethorphan/Dextrorphan (Parent/Metabolite) AUClast ratio||1.138|0.721|
70854153|NCT00977080|141196537|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED|95.0||||No adjustments were made for multiple comparisons between treatment groups since the study was designed to evaluate the primary outcome measure by testing a single hypothesis within each stratum independently.|Fisher Exact|||With a sample size of 49 participants in each treatment group in the IV stratum, a Fisher's exact test with a 0.050 2-sided significance level will have 81% power to detect a 30% difference in the percentage of participants who achieve iPTH between 150 and 300 pg/mL, assuming the cinacalcet percentage is 36% and the paricalcitol percentage is 66%.||||0.016
70854154|NCT00977080|141196537|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED|95.0||||No adjustments were made for multiple comparisons between treatment groups since the study was designed to evaluate the primary outcome measure by testing a single hypothesis within each stratum independently.|Fisher Exact|||With a sample size of 49 participants in each treatment group in the oral stratum, a Fisher's exact test with a 0.050 2-sided significance level will have 81% power to detect a 30% difference in the percentage of participants who achieve iPTH between 150 and 300 pg/mL, assuming the cinacalcet percentage is 36% and the paricalcitol percentage is 66%.||||0.260
70854155|NCT00977080|141196538|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
70854156|NCT00977080|141196538|SUPERIORITY_OR_OTHER|||||||0.239||95.0|||||Fisher Exact|||||||0.239
70854157|NCT00977080|141196539|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
70854158|NCT00977080|141196539|SUPERIORITY_OR_OTHER|||||||0.704||95.0|||||Fisher Exact|||||||0.704
70854159|NCT00977080|141196540|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Cochran-Mantel-Haenszel|||||||0.010
70854160|NCT00977080|141196541|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
70854161|NCT00977080|141196541|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
70854162|NCT00977080|141196542|SUPERIORITY_OR_OTHER|||||||0.118||95.0|||||Fisher Exact|||||||0.118
70854163|NCT00977080|141196542|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
70854164|NCT00441116|141196546|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|7.54|STANDARD_DEVIATION|20.37||0.0319||95.0|0.75|14.33|||t-test, 2 sided||Mean difference = Drug A minus Drug B|Month 6 - Baseline||14.33|0.75|0.0319
70854165|NCT03192358|141196578|SUPERIORITY||Cohen's d|1.18|||<|0.001|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05.|ANOVA||Cohen's d values \> 0.8 are considered large|This was an observational study. The statistical test explores whether there were significant differences in tongue pressure between the two cohorts. The hypothesis was that individuals with ALS would display significantly lower maximum anterior isometric tongue pressures compared to the people with PD.||||< 0.001
70854166|NCT03192358|141196579|SUPERIORITY||Cohen's d|1.75|||<|0.001|TWO_SIDED||||||ANOVA||Cohen's d values \> 0.8 are considered large|This was an observational study rather than a trial. The hypothesis was that individuals with ALS would display significantly lower regular effort saliva swallow pressures than the individuals with PD.||||< 0.001
70871973|NCT02207244|141229261|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= -10.0%|Difference in Percentage|23.3|||<|0.001|TWO_SIDED|95.0|16.0|30.4|||MH Z-test|||p value is based on 1-sided MH Z-test adjusted for investigator site (pooled).||30.4|16.0|< 0.001
70854167|NCT00796991|141196626|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.963|||||TWO_SIDED|90.0|0.794|1.168|||Mixed Models Analysis|A general linear mixed model was applied to paclitaxel log(Cmax) using study day as a fixed effect.||Estimated effect of ipilimumab on paclitaxel Cmax. Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the paclitaxel/carboplatin/ipilimumab combination (Day 43) relative to paclitaxel/carboplatin alone (Day 1)||1.168|0.794|
70854168|NCT00796991|141196626|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.027|||||TWO_SIDED|90.0|0.848|1.243|||Mixed Models Analysis|study day was used as a fixed effect||Estimated effect of ipilimumab on dacarbazine Cmax. Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination (Day 43) relative to dacarbazine alone (Day 1).||1.243|0.848|
70854169|NCT00796991|141196626|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.058|||||TWO_SIDED|90.0|0.974|1.15|||Mixed Models Analysis|study day was used as a fixed effect||Estimated effect of ipilimumab on AIC Cmax. Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination (Day 43) relative to dacarbazine alone (Day 1).||1.150|0.974|
70854170|NCT00796991|141196626|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.934||||||90.0|0.768|1.136|||linear model|treatment arm as a fixed effect||Estimated effect of paclitaxel/carboplatin on ipilimumab Cmax: linear model was applied to ipilimumab log(Cmax)) data from Week 7 (Day 43) PK measurements in first and third arms with treatment arm as a fixed effect. Point estimates and 90% CIs for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the 3 drug combination relative to ipilimumab alone.||1.136|0.768|
70854171|NCT00796991|141196626|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.982|||||TWO_SIDED|90.0|0.798|1.208|||linear model|treatment arm as a fixed effect||Estimated effect of dacarbazine on ipilimumab Cmax: linear model was applied to ipilimumab log(Cmax) data from Week 7 (Day 43) PK measurements in second and third arms with treatment arm as a fixed effect. Point estimates and 90% CIs for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination relative to ipilimumab alone.||1.208|0.798|
70854172|NCT00796991|141196630|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.068|||||TWO_SIDED|90.0|0.954|1.196|||Mixed Models Analysis|A general linear mixed model was applied to paclitaxel log\[AUC(INF)\] using study day as a fixed effect.||Estimated effect of ipilimumab on paclitaxel AUC(INF). Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the paclitaxel/carboplatin/ipilimumab combination (Day 43) relative to paclitaxel/carboplatin alone (Day 1).||1.196|0.954|
70854173|NCT00796991|141196630|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.912|||||TWO_SIDED|90.0|0.757|1.099|||Mixed Models Analysis|A general linear mixed model was applied to dacarbazine log\[AUC(INF)\] using study day as a fixed effect.||Estimated effect of ipilimumab on dacarbazine AUC(INF). Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination (Day 43) relative to dacarbazine alone (Day 1).||1.099|0.757|
70854174|NCT00796991|141196630|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.891|1.056|||Mixed Models Analysis|A general linear mixed model was applied to active metabolite AIC log\[AUC(INF)\] using study day as a fixed effect.||Estimated effect of ipilimumab on AUC(INF) for AIC. Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination (Day 43) relative to dacarbazine alone (Day 1).||1.056|0.891|
70854175|NCT00796991|141196630|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.934|||||TWO_SIDED|90.0|0.768|1.136|||linear model|treatment arm as fixed effect||Estimated effect of paclitaxel/carboplatin on ipilimumab AUC: linear model was applied to ipilimumab log(AUC(0-21d)) data from Week 7 (Day 43) PK measurements in first and third arms with treatment arm as a fixed effect. Point estimates and 90% CIs for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the 3 drug combination relative to ipilimumab alone.||1.136|0.768|
70854176|NCT00796991|141196630|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.982|||||TWO_SIDED|90.0|0.7981|1.208|||linear model|treatment arm as a fixed effect||Estimated effect of dacarbazine on ipilimumab AUC: linear model was applied to ipilimumab log(AUC(0-21d)) data from Week 7 (Day 43) PK measurements in second and third arms with treatment arm as a fixed effect. Point estimates and 90% CIs for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination relative to ipilimumab alone.||1.208|0.7981|
70854177|NCT00796991|141196636|SUPERIORITY_OR_OTHER|||||||0.027||||||p-value was not corrected for multiple testing. F-statistic = 1.86.|conditional F test|15 degrees freedom (DF) in numerator and 335 DF in denominator.||null hypothesis of no mean ALC changes over time in any treatment group. Conditional F-tests were used to test for mean ALC changes over time in each treatment arm and the difference between treatment arms in the pattern of change in ALC over time.||||0.027
70854178|NCT00796991|141196636|SUPERIORITY_OR_OTHER|||||||0.5||||||P-values were not corrected for multiple testing. F Statistic =0.94|Omnibus conditional F-test|10 Degrees Freedom (DF) in numerator and 335 DF in denominator.||null hypothesis that the pattern of mean ALC values over time is the same in all treatment groups. Test of overall time-by-treatment interaction used an omnibus conditional F-test.||||0.5
70854179|NCT00796991|141196636|SUPERIORITY_OR_OTHER|||||||0.37||||||P-values were not corrected for multiple testing. F Statistic =1.08|conditional F-test|5 Degrees Freedom (DF) in numerator and 335 DF in denominator.||null hypothesis that the pattern of mean ALC values over time is the same in the given pair of treatment groups.||||0.37
70854180|NCT00796991|141196636|SUPERIORITY_OR_OTHER|||||||0.85||||||P-values were not corrected for multiple testing. F Statistic =0.39|conditional F-test|5 Degrees Freedom (DF) in numerator and 335 DF in denominator.||null hypothesis that the pattern of mean ALC values over time is the same in the given pair of treatment groups.||||0.85
70941991|NCT02507687|141384385|NON_INFERIORITY|"Statistical non-inferiority of Bimatoprost SR 10 µg to SLT was demonstrated if the upper limit of the 95% confidence interval (CI) for the least squares (LS) mean difference between the Bimatoprost SR 10 µg eyes and SLT eyes was ≤ 1.5 mmHg at Weeks 4, 12, and 24.~Clinical non-inferiority of Bimatoprost SR 10 µg to SLT was considered if the upper limit of the 95% CI was ≤ 1.0 mmHg at 2 out of the 3 visits of Weeks 4, 12, and 24."|LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.31||0.1615|TWO_SIDED|95.0|-1.04|0.18|||Mixed Effect Model Repeated Measurement|The model includes treatment, visit, eye, baseline IOP, treatment-by-visit, visit-by-baseline, and visit-by-eyes interactions as covariates.||||0.18|-1.04|0.1615
70941992|NCT02507687|141384386|NON_INFERIORITY|"Statistical non-inferiority of Bimatoprost SR 10 µg to SLT was demonstrated if the upper limit of the 95% confidence interval (CI) for the least squares (LS) mean difference between the Bimatoprost SR 10 µg eyes and SLT eyes was ≤ 1.5 mmHg at Weeks 4, 12, and 24.~Clinical non-inferiority of Bimatoprost SR 10 µg to SLT was considered if the upper limit of the 95% CI was ≤ 1.0 mmHg at 2 out of the 3 visits of Weeks 4, 12, and 24."|LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.29||0.1673|TWO_SIDED|95.0|-0.97|0.17|||Mixed Effect Model Repeated Measurement|The model includes treatment, visit, eye, baseline IOP, treatment-by-visit, visit-by-baseline, and visit-by-eyes interactions as covariates.||||0.17|-0.97|0.1673
70941993|NCT02675998|141384390|SUPERIORITY|||||||0.01|||||||ANCOVA|||||||0.01
70941994|NCT02675998|141384391|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
70941995|NCT02675998|141384391|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
70941996|NCT02675998|141384391|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
70941997|NCT04357964|141384394|EQUIVALENCE|Statistical significance was defined as p\< 0.05 for determining difference between groups at baseline in this observational study. There was no treatment intervention in this study, so there is no true equivalence margin.|||||<|0.01||||||Statistical significance was defined as p\< 0.05|Kruskal-Wallis|||||||<0.01
70941998|NCT04357964|141384395|EQUIVALENCE|Statistical significance was defined as p \< 0.05. There was no intervention in this study, so there is no true equivalence margin.|||||<|0.01|||||||Pearson correlation|||||||<0.01
70941999|NCT04357964|141384396|EQUIVALENCE|Statistical significance was defined as p\< 0.05 for determining difference between groups in this observational study. There was no treatment intervention in this study, so there is no true equivalence margin.||||||0.52||||||Statistical significance was defined as p\< 0.05|Kruskal-Wallis|||||||0.52
70871974|NCT02207244|141229261|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
70942000|NCT02288364|141384428|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Chi-squared|||||||0.30
70942001|NCT02288364|141384429|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Chi-squared|||||||0.08
71117747|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|0.43||||0.953|TWO_SIDED|95.0|-13.8|14.65||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.65|-13.80|0.953
70942002|NCT02288364|141384430|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Chi-squared|||||||0.29
70942003|NCT00043186|141384441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.87|||<|0.001||95.0|4.59|7.16|||ANCOVA|||||7.16|4.59|<0.001
70942004|NCT00043186|141384441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.33|||<|0.001||95.0|5.01|7.65|||ANCOVA|||||7.65|5.01|<0.001
70942005|NCT00043186|141384441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.35|||<|0.001||95.0|4.07|6.64|||ANCOVA|||||6.64|4.07|<0.001
70942006|NCT00043186|141384441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.84|||<|0.001||95.0|2.6|5.07|||ANCOVA|||||5.07|2.60|<0.001
70942007|NCT00043186|141384441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.5|||<|0.001||95.0|6.13|8.87|||ANCOVA|||||8.87|6.13|<0.001
70942008|NCT00043186|141384441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.52|||<|0.001||95.0|4.19|6.85|||ANCOVA|||||6.85|4.19|<0.001
70942009|NCT00043186|141384441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.21|||<|0.001||95.0|3.88|6.55|||ANCOVA|||||6.55|3.88|<0.001
70942010|NCT00043186|141384442|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942011|NCT00043186|141384442|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942012|NCT00043186|141384442|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942013|NCT00043186|141384442|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942014|NCT00043186|141384442|SUPERIORITY_OR_OTHER|||||||0.166|||||||Wilcoxon (Mann-Whitney)|||||||0.166
70942015|NCT00043186|141384442|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942016|NCT00043186|141384442|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942017|NCT00043186|141384442|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942018|NCT00043186|141384443|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942019|NCT00043186|141384443|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942020|NCT00043186|141384443|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942021|NCT00043186|141384443|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942022|NCT00043186|141384443|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942023|NCT00043186|141384443|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942024|NCT00043186|141384443|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
70942025|NCT00043186|141384443|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942026|NCT00043186|141384445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.34|||<|0.001||95.0|5.56|9.12|||ANCOVA|||||9.12|5.56|<0.001
70854181|NCT00796991|141196636|SUPERIORITY_OR_OTHER|||||||0.22||||||P-values were not corrected for multiple testing. F Statistic = 1.41|conditional F-test|5 Degrees Freedom (DF) in numerator and 335 DF in denominator.||null hypothesis that the pattern of mean ALC values over time is the same in the given pair of treatment groups.||||0.22
70854182|NCT02184624|141196667|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical comparison for categories Error while using only ELLIPTA inhaler Vs Error while using DISKUS/ACCUHALER|Cochran-Mantel-Haenszel|||||||<0.001
70854183|NCT02184624|141196667|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using MDI|Cochran-Mantel-Haenszel|||||||<0.001
70854184|NCT02184624|141196667|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using TURBUHALER|Cochran-Mantel-Haenszel|||||||<0.001
70854185|NCT02184624|141196667|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using HANDIHALER|Cochran-Mantel-Haenszel|||||||<0.001
70854186|NCT02184624|141196667|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using BREEZHALER|Cochran-Mantel-Haenszel|||||||<0.001
70854187|NCT02184624|141196668|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using DISKUS/ACCUHALER|Cochran-Mantel-Haenszel|||||||<0.001
70854188|NCT02184624|141196668|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using MDI|Cochran-Mantel-Haenszel|||||||<0.001
70854189|NCT02184624|141196668|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using TURBUHALER|Cochran-Mantel-Haenszel|||||||<0.001
70854190|NCT02184624|141196668|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using HANDIHALER|Cochran-Mantel-Haenszel|||||||<0.001
70854191|NCT02184624|141196668|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using BREEZHALER|Cochran-Mantel-Haenszel|||||||<0.001
70854192|NCT02184624|141196669|SUPERIORITY_OR_OTHER|||||||0.48||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using DISKUS/ACCUHALER|Cochran-Mantel-Haenszel|||||||0.480
70854193|NCT02184624|141196669|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using MDI|Cochran-Mantel-Haenszel|||||||0.044
70854194|NCT02184624|141196669|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using TURBUHALER|Cochran-Mantel-Haenszel|||||||0.025
70854195|NCT02184624|141196669|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using HANDIHALER|Cochran-Mantel-Haenszel|||||||<0.001
70854196|NCT02184624|141196669|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using BREEZHALER|Cochran-Mantel-Haenszel|||||||0.014
70854197|NCT02184624|141196670|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using DISKUS/ACCUHALER|Cochran-Mantel-Haenszel|||||||<0.001
70854198|NCT02184624|141196670|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using MDI|Cochran-Mantel-Haenszel|||||||<0.001
70854199|NCT02184624|141196670|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using TURBUHALER|Cochran-Mantel-Haenszel|||||||0.002
70854200|NCT02184624|141196670|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using HANDIHALER|Cochran-Mantel-Haenszel|||||||0.001
70854201|NCT02184624|141196670|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using BREEZHALER|Cochran-Mantel-Haenszel|||||||0.003
70854202|NCT02184624|141196671|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for DISKUS/ACCUHALER inhaler|Wilcoxon signed rank test|||||||<0.001
70854203|NCT02184624|141196671|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for MDI inhaler|Wilcoxon signed rank test|||||||<0.001
70854204|NCT02184624|141196671|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for TURBUHALER inhaler|Wilcoxon signed rank test|||||||<0.001
70854205|NCT02184624|141196671|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for HANDIHALER inhaler|Wilcoxon signed rank test|||||||<0.001
70854206|NCT02184624|141196671|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for BREEZHALER inhaler|Wilcoxon signed rank test|||||||<0.001
70854207|NCT02184624|141196672|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring DISKUS/ACCUHALER device as assessed by the 'preference' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
70854208|NCT02184624|141196672|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Number of participants preferring ELLIPTA device versus number of participants preferring MDI device as assessed by the 'preference' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
70854209|NCT02184624|141196672|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring TURBUHALER device as assessed by the 'preference' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
70854210|NCT02184624|141196672|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring HANDIHALER device as assessed by the 'preference' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
70942027|NCT00043186|141384445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.11|||<|0.001||95.0|7.31|10.91|||ANCOVA|||||10.91|7.31|<0.001
70942028|NCT00043186|141384445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.56|||<|0.001||95.0|6.71|10.41|||ANCOVA|||||10.41|6.71|<0.001
70942029|NCT00043186|141384445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.44|||<|0.001||95.0|6.69|10.19|||ANCOVA|||||10.19|6.69|<0.001
70942030|NCT00043186|141384445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.19|||<|0.001||95.0|3.43|6.94|||ANCOVA|||||6.94|3.43|<0.001
70942031|NCT00043186|141384445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.08|||<|0.001||95.0|8.14|12.01|||ANCOVA|||||12.01|8.14|<0.001
70942032|NCT00043186|141384445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.46|||<|0.001||95.0|6.62|10.3|||ANCOVA|||||10.30|6.62|<0.001
70942033|NCT00043186|141384445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.66|||<|0.001||95.0|6.8|10.53|||ANCOVA|||||10.53|6.80|<0.001
70942034|NCT00043186|141384446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.5|||<|0.001||95.0|4.32|8.67|||ANCOVA|||||8.67|4.32|<0.001
70942035|NCT00043186|141384446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.65||||0.013||95.0|0.55|4.75|||ANCOVA|||||4.75|0.55|0.013
70854211|NCT02184624|141196672|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring BREEZHALER device as assessed by the 'preference' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
70942036|NCT00043186|141384446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.43|||<|0.001||95.0|10.19|14.68|||ANCOVA|||||14.68|10.19|<0.001
70942037|NCT00043186|141384446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.84|||<|0.001||95.0|8.74|12.94|||ANCOVA|||||12.94|8.74|<0.001
70942038|NCT00043186|141384446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.79|||<|0.001||95.0|7.69|11.89|||ANCOVA|||||11.89|7.69|<0.001
70942039|NCT00043186|141384446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.74|||<|0.001||95.0|1.37|6.12|||ANCOVA|||||6.12|1.37|<0.001
70942040|NCT00043186|141384446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.97|||<|0.001||95.0|8.63|13.32|||ANCOVA|||||13.32|8.63|<0.001
70942041|NCT00043186|141384446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.37|||<|0.001||95.0|8.16|12.59|||ANCOVA|||||12.59|8.16|<0.001
70942042|NCT00043186|141384447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.42||||0.02||95.0|0.89|9.95|||ANCOVA|||||9.95|0.89|0.02
70942043|NCT00043186|141384447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.992||95.0|-5.07|5.02|||ANCOVA|||||5.02|-5.07|0.992
70942044|NCT00043186|141384447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9||||0.004||95.0|3.72|14.09|||ANCOVA|||||14.09|3.72|0.004
70942045|NCT00043186|141384447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.5||||0.001||95.0|4.15|12.86|||ANCOVA|||||12.86|4.15|0.001
70942046|NCT00043186|141384447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.37||||0.001||95.0|4.11|12.63|||ANCOVA|||||12.63|4.11|0.001
70942047|NCT00043186|141384447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.98||||0.292||95.0|-1.42|9.37|||ANCOVA|||||9.37|-1.42|0.292
70942048|NCT00043186|141384447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.95||||0.004||95.0|3.94|13.96|||ANCOVA|||||13.96|3.94|0.004
70942049|NCT00043186|141384447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.12||||0.094||95.0|0.57|11.67|||ANCOVA|||||11.67|0.57|0.094
70942050|NCT00043186|141384448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.93|||<|0.001||95.0|3.97|9.89|||ANCOVA|||||9.89|3.97|<0.001
70942051|NCT00043186|141384448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.89|||<|0.001||95.0|1.92|7.85|||ANCOVA|||||7.85|1.92|<0.001
70942052|NCT00043186|141384448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.15|||<|0.001||95.0|11.08|17.21|||ANCOVA|||||17.21|11.08|<0.001
70942053|NCT00043186|141384448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.73|||<|0.001||95.0|9.94|15.52|||ANCOVA|||||15.52|9.94|<0.001
70942054|NCT00043186|141384448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.49|||<|0.001||95.0|9.66|15.32|||ANCOVA|||||15.32|9.66|<0.001
70942055|NCT00043186|141384448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.42|||<|0.001||95.0|8.12|14.73|||ANCOVA|||||14.73|8.12|<0.001
70942056|NCT00043186|141384448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.32|||<|0.001||95.0|9.15|15.49|||ANCOVA|||||15.49|9.15|<0.001
70942057|NCT00043186|141384448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.74|||<|0.001||95.0|8.72|14.76|||ANCOVA|||||14.76|8.72|<0.001
70942058|NCT00043186|141384449|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942059|NCT00043186|141384449|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942060|NCT00043186|141384449|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942061|NCT00043186|141384449|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942062|NCT00043186|141384449|SUPERIORITY_OR_OTHER|||||||0.622|||||||Wilcoxon (Mann-Whitney)|||||||0.622
70942063|NCT00043186|141384449|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942064|NCT00043186|141384449|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942065|NCT00043186|141384449|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942066|NCT00043186|141384450|SUPERIORITY_OR_OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
70942067|NCT00043186|141384450|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942068|NCT00043186|141384450|SUPERIORITY_OR_OTHER|||||||0.026|||||||Wilcoxon (Mann-Whitney)|||||||0.026
70942069|NCT00043186|141384450|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
70942070|NCT00043186|141384450|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942071|NCT00043186|141384450|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942072|NCT00043186|141384450|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942073|NCT00043186|141384450|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942074|NCT00043186|141384451|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942075|NCT00043186|141384451|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
70854212|NCT02184624|141196673|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring DISKUS/ACCUHALER device by the 'ease of use' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
70854213|NCT02184624|141196673|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Number of participants preferring ELLIPTA device versus number of participants preferring MDI device by the 'ease of use' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
71079553|NCT01420016|141666526|EQUIVALENCE|The analysis used a time-by-condition mixed model to estimate the annual rate of change in post-index CV risk values by treatment group. The models included fixed effects for study arm (CDS vs. UC), time (years since index), and study-arm-by-time comparing the rate of change in CDS versus UC and a random clinic intercept. The intervention effect was the difference in rate of change in CDS versus UC clinics, with the study-arm-by-time interaction assessing statistical significance (P\<0.05).|Slope Difference (Net)|-2.25|||<|0.05|TWO_SIDED|95.0|-3.45|-1.04||A priori power analysis (power=.80, α2=.05) estimated detectable group difference in CVR at 1 year of \~2-3%, assuming 18 clinics, 1000 patients per clinic (actual 400), 3 CVR per patient (actual 2.3), and ICC=.01-03 (actual .019). p-value calculated.|Mixed Models Analysis||The intervention effect was the difference in annualized rates of change (slope) in CV risk in CDS versus UC clinics, with the study-arm-by-time interaction assessing statistical significance (P\<0.05).|||-1.04|-3.45|<0.05
71079554|NCT01454414|141666527|SUPERIORITY_OR_OTHER_LEGACY||Protective effectiveness= 1 - rate ratio|0.646||||0.004|TWO_SIDED|95.0|0.288|0.824|||Poisson regression|||Protective effectiveness (1 - the incidence rate ratio) and 95% CIs for comparing reported tick bites between the treatment and control groups were calculated using a GEE model with a Poisson distribution and log link, and included terms for treatment, year of follow-up, and the interaction of treatment and year of follow-up, with an offset variable for log outdoor work hours.||0.824|0.288|0.004
71079555|NCT04679948|141666538|OTHER||Ratio of GLSMs [%]|112.06|||||TWO_SIDED|90.0|101.02|124.3|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + caffeine/GLSM of caffeine). Intra-individual geometric coefficient of variation (gCV \[%\]) =16.2."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||124.30|101.02|
71079556|NCT04679948|141666539|OTHER||Ratio of GLSMs [%]|96.74|||||TWO_SIDED|90.0|91.55|102.23|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + caffeine/GLSM of caffeine). Intra-individual geometric coefficient of variation (gCV \[%\]) = 8.6."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||102.23|91.55|
71079557|NCT04679948|141666540|OTHER||Ratio of GLSMs [%]|110.38|||||TWO_SIDED|90.0|107.15|113.71|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + warfarin/GLSM of Warfarin). Intra-individual geometric coefficient of variation (gCV \[%\]) =4.8."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||113.71|107.15|
71079558|NCT04679948|141666541|OTHER||Ratio of GLSMs [%]|108.47|||||TWO_SIDED|90.0|104.11|113.01|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + warfarin/GLSM of Warfarin). Intra-individual geometric coefficient of variation (gCV \[%\]) = 6.6."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||113.01|104.11|
71079559|NCT04679948|141666542|OTHER||Ratio of GLSM [%]|99.74|||||TWO_SIDED|90.0|89.66|110.95|||||"Ratio of Geometric Least Squares Means (GLSM) was calculated as (GLSM of BI 730357 + omeprazole/GLSM of Omeprazole). Intra-individual geometric coefficient of variation (gCV \[%\]) =12.3."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||110.95|89.66|
71079560|NCT04679948|141666543|OTHER||Ratio of GLSMs [%]|71.32|||||TWO_SIDED|90.0|44.64|113.96|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + omeprazole/GLSM of Omeprazole). Intra-individual geometric coefficient of variation (gCV \[%\]) =87.8."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||113.96|44.64|
70942076|NCT00043186|141384451|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
70942077|NCT00043186|141384451|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
70942078|NCT00043186|141384451|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
70942079|NCT00043186|141384451|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
70942080|NCT00043186|141384451|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
70942081|NCT00043186|141384451|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942082|NCT00043186|141384452|SUPERIORITY_OR_OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||||||0.015
70942083|NCT00043186|141384452|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.050
70942084|NCT00043186|141384452|SUPERIORITY_OR_OTHER|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||||||0.029
70942085|NCT00043186|141384452|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
70854214|NCT02184624|141196673|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Number of participants preferring ELLIPTA device versus number of participants preferring TURBUHALER device by the 'ease of use' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
70942086|NCT00043186|141384452|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
70942087|NCT00043186|141384452|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.050
70942088|NCT00043186|141384452|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.050
70854215|NCT02184624|141196673|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Number of participants preferring ELLIPTA device versus number of participants preferring HANDIHALER device by the 'ease of use' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
70942089|NCT00043186|141384452|SUPERIORITY_OR_OTHER|||||||0.073|||||||Wilcoxon (Mann-Whitney)|||||||0.073
70942090|NCT00043186|141384453|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942091|NCT00043186|141384453|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942092|NCT00043186|141384453|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
70942093|NCT00043186|141384453|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942094|NCT00043186|141384453|SUPERIORITY_OR_OTHER|||||||0.409|||||||Wilcoxon (Mann-Whitney)|||||||0.409
70942095|NCT00043186|141384453|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942096|NCT00043186|141384453|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
70942097|NCT00043186|141384453|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
70942098|NCT00043186|141384454|SUPERIORITY_OR_OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
70942099|NCT00043186|141384454|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942100|NCT00043186|141384454|SUPERIORITY_OR_OTHER|||||||0.077|||||||Wilcoxon (Mann-Whitney)|||||||0.077
70942101|NCT00043186|141384454|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
70942102|NCT00043186|141384454|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942103|NCT00043186|141384454|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
70942104|NCT00043186|141384454|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
70942105|NCT00043186|141384454|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
70942106|NCT00043186|141384455|SUPERIORITY_OR_OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||||||0.053
70942107|NCT00043186|141384455|SUPERIORITY_OR_OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||||||0.053
70942108|NCT00043186|141384455|SUPERIORITY_OR_OTHER|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||||||0.022
70942109|NCT00043186|141384455|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
70942110|NCT00043186|141384455|SUPERIORITY_OR_OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||||||0.053
70942111|NCT00043186|141384455|SUPERIORITY_OR_OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||||||0.053
70942112|NCT00043186|141384455|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
70942113|NCT00043186|141384455|SUPERIORITY_OR_OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||||||0.053
70942114|NCT00043186|141384456|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.010
70942115|NCT00043186|141384456|SUPERIORITY_OR_OTHER|||||||0.172|||||||Wilcoxon (Mann-Whitney)|||||||0.172
70942116|NCT00043186|141384456|SUPERIORITY_OR_OTHER|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||||||0.029
70942117|NCT00043186|141384456|SUPERIORITY_OR_OTHER|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||||||0.047
70942118|NCT00043186|141384456|SUPERIORITY_OR_OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||||||0.015
70942119|NCT00043186|141384456|SUPERIORITY_OR_OTHER|||||||0.168|||||||Wilcoxon (Mann-Whitney)|||||||0.168
70942120|NCT00043186|141384456|SUPERIORITY_OR_OTHER|||||||0.168|||||||Wilcoxon (Mann-Whitney)|||||||0.168
70942121|NCT00043186|141384456|SUPERIORITY_OR_OTHER|||||||0.172|||||||Wilcoxon (Mann-Whitney)|||||||0.172
70942122|NCT00043186|141384457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.67|||<|0.001||95.0|1.7|3.64|||ANCOVA|||||3.64|1.70|<0.001
70942123|NCT00043186|141384457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9|||<|0.001||95.0|1.9|3.89|||ANCOVA|||||3.89|1.90|<0.001
70942124|NCT00043186|141384457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.09|||<|0.001||95.0|2.07|4.11|||ANCOVA|||||4.11|2.07|<0.001
70942125|NCT00043186|141384457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.12|||<|0.001||95.0|3.13|5.11|||ANCOVA|||||5.11|3.13|<0.001
70942126|NCT00043186|141384457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||<|0.001||95.0|1.55|3.46|||ANCOVA|||||3.46|1.55|<0.001
70942127|NCT00043186|141384457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.89|||<|0.001||95.0|2.83|4.95|||ANCOVA|||||4.95|2.83|<0.001
70942128|NCT00043186|141384457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.01|||<|0.001||95.0|1.99|4.04|||ANCOVA|||||4.04|1.99|<0.001
70942129|NCT00043186|141384457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.46|||<|0.001||95.0|2.43|4.48|||ANCOVA|||||4.48|2.43|<0.001
70942130|NCT00043186|141384458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.19|||<|0.001||95.0|4.04|6.34|||ANCOVA|||||6.34|4.04|<0.001
70942131|NCT00043186|141384458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1|||<|0.001||95.0|4.93|7.27|||ANCOVA|||||7.27|4.93|<0.001
70942132|NCT00043186|141384458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.59|||<|0.001||95.0|4.4|6.78|||ANCOVA|||||6.78|4.40|<0.001
70854216|NCT02184624|141196673|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Number of participants preferring ELLIPTA device versus number of participants preferring BREEZHALER device by the 'ease of use' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
70854217|NCT02365233|141196679|SUPERIORITY||||||||||||||||||IRB withheld the data due to inadequate supporting documentation|||
70854218|NCT01978938|141196680|NON_INFERIORITY|The NI test was based on the lower limit of the 2-sided 95% confidence interval (CI), using the method proposed without stratification by Miettinen and Nurminen. If the lower limit of the 95% CI for the difference in Responder (clinical cure and microbiologic success) rates in the micro-ITT population exceeded -10%, then the null hypothesis was rejected and the NI of eravacycline to levofloxacin was declared.|Treatment Difference|-6.5|||||TWO_SIDED|95.0|-14.1|1.2||||||For the FDA, an NI margin of 10% was used, which was based on historical data regarding the treatment effect of antibiotics. A 10% NI margin for the Responder outcome is robust and can sufficiently confirm a clinically meaningful treatment effect of eravacycline in the treatment of cUTI.||1.2|-14.1|
70942133|NCT00043186|141384458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.89|||<|0.001||95.0|5.76|8.01|||ANCOVA|||||8.01|5.76|<0.001
70854219|NCT02342418|141196683|SUPERIORITY_OR_OTHER|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||||||0.314
70854220|NCT02342418|141196684|SUPERIORITY_OR_OTHER|||||||0.214|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon matched-pair signed-rank test||||0.214
70854221|NCT00428584|141196689|SUPERIORITY_OR_OTHER|||||||0.524||||||P value refers to mean change to 30 minute post injection|ANOVA|||The primary efficacy endpoint was analyzed by using a two-way ANOVA model on ranked data including treatment group and site as fixed effect.||||0.524
70854222|NCT00428584|141196690|SUPERIORITY_OR_OTHER|||||||0.484|||||||ANOVA|||||||0.484
70854223|NCT00428584|141196691|SUPERIORITY_OR_OTHER|||||||0.838|||||||ANOVA|||||||0.838
70854224|NCT00428584|141196692|SUPERIORITY_OR_OTHER|||||||0.451||||||No pain is defined as a VAS = 0 for all 21 full dose injections.|Cochran-Mantel-Haenszel|||||||0.451
70854225|NCT00428584|141196693|SUPERIORITY_OR_OTHER|||||||0.338|||||||ANOVA|||||||0.338
70871975|NCT02207244|141229262|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= -10%|Difference in percentage|17.7|||<|0.001|TWO_SIDED|95.0|11.4|24.4|||MH Z-test|||p value is based on 1-sided MH Z-test adjusted for investigator site (pooled).||24.4|11.4|< 0.001
70942134|NCT00043186|141384458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.54|||<|0.001||95.0|3.41|5.67|||ANCOVA|||||5.67|3.41|<0.001
70942135|NCT00043186|141384458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.95|||<|0.001||95.0|5.69|8.21|||ANCOVA|||||8.21|5.69|<0.001
70942136|NCT00043186|141384458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.48|||<|0.001||95.0|4.29|6.67|||ANCOVA|||||6.67|4.29|<0.001
70942137|NCT00043186|141384458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.97|||<|0.001||95.0|4.76|7.17|||ANCOVA|||||7.17|4.76|<0.001
70942138|NCT00043186|141384459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.78|||<|0.001||95.0|2.19|5.36|||ANCOVA|||||5.36|2.19|<0.001
70942139|NCT00043186|141384459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.41||||0.07||95.0|-0.12|2.94|||ANCOVA|||||2.94|-0.12|0.07
70942140|NCT00043186|141384459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.17|||<|0.001||95.0|5.54|8.8|||ANCOVA|||||8.80|5.54|<0.001
70942141|NCT00043186|141384459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.67|||<|0.001||95.0|7.13|10.21|||ANCOVA|||||10.21|7.13|<0.001
70942142|NCT00043186|141384459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.15|||<|0.001||95.0|5.62|8.69|||ANCOVA|||||8.69|5.62|<0.001
70854226|NCT02285062|141196705|SUPERIORITY||Hazard Ratio (HR)|0.849||||0.2864|TWO_SIDED|95.0|0.632|1.14|||Log Rank|Stratified by: IPI score (2 or ≥ 3), presence or absence of bulky disease (diameter of the lesion ≥ 7 cm or \< 7 cm), and age (\< 65 or ≥ 65 years).|Hazard ratio was derived from Cox proportional hazard model adjusting for the 3 stratification factors|||1.140|0.632|0.2864
70854227|NCT02285062|141196706|SUPERIORITY||Hazard Ratio (HR)|1.038||||0.7294|TWO_SIDED|95.0|0.802|1.344|||Log Rank|Stratified by: IPI score (2 or ≥ 3), presence or absence of bulky disease (diameter of the lesion ≥ 7 cm or \< 7 cm), and age (\< 65 or ≥ 65 years).|Hazard ratio was derived from Cox proportional hazard model adjusting for the 3 stratification factors.|||1.344|0.802|0.7294
70854228|NCT02285062|141196707|SUPERIORITY||Hazard Ratio (HR)|0.965||||0.876|TWO_SIDED|95.0|0.716|1.3|||Log Rank|Log-rank test stratified by 3 factors: IPI score (2 or ≥ 3), presence of bulky disease (bulky or nonbulky), and age (\< 65 or ≥ 65).|Hazard ratio was derived from Cox proportional hazard model adjusting for the 3 stratification factors.|||1.300|0.716|0.8760
70942143|NCT00043186|141384459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.61||||0.07||95.0|-0.12|3.35|||ANCOVA|||||3.35|-0.12|0.07
70942144|NCT00043186|141384459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.26|||<|0.001||95.0|5.56|8.95|||ANCOVA|||||8.95|5.56|<0.001
70854229|NCT02285062|141196708|SUPERIORITY|||||||0.2933||||||Obtained from CMH test adjusting for stratification factors: IPI score (2 or ≥ 3), presence of bulky disease (bulky or nonbulky), and age (\< 65 or ≥ 65)|Cochran-Mantel-Haenszel|||||||0.2933
71079561|NCT04679948|141666544|OTHER||Ratio of GLSMs [%]|126.85|||||TWO_SIDED|90.0|119.15|135.05|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + midazolam/GLSM of Midazolam). Intra-individual geometric coefficient of variation (gCV \[%\]) =10.1."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||135.05|119.15|
71079562|NCT04679948|141666545|OTHER||Ratio of GLSMs [%]|130.25|||||TWO_SIDED|90.0|121.25|139.92|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + midazolam/GLSM of Midazolam). Intra-individual geometric coefficient of variation (gCV \[%\]) =11.6."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||139.92|121.25|
71079563|NCT02636439|141666546|SUPERIORITY||Mean Difference (Final Values)|44.0||||0.21|TWO_SIDED|95.0|-25.0|112.0|||ANCOVA|adjusted for baseline value, age, and sex.||||112|-25|0.21
71079564|NCT02636439|141666547|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.86|TWO_SIDED|95.0|-1.0|0.8|||ANCOVA|Adjusted for baseline value, age, and sex.||||0.8|-1.0|0.86
71079565|NCT02636439|141666548|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.77|TWO_SIDED|95.0|-2.8|3.8|||ANCOVA|Adjusted for baseline value, age, and sex.||||3.8|-2.8|0.77
71079566|NCT02636439|141666549|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.85|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|Adjusted for baseline value, age, and sex.||||0.2|-0.3|0.85
71079567|NCT02636439|141666550|SUPERIORITY||Mean Difference (Final Values)|6.4||||0.053|TWO_SIDED|95.0|-0.1|12.9|||ANCOVA|Adjusted for baseline value, age, and sex.||||12.9|-0.1|0.053
71079568|NCT02636439|141666551|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.043|TWO_SIDED|95.0|0.0|0.13|||ANCOVA|Adjusted for baseline value, age, and sex.||||0.13|0.00|0.043
71079569|NCT02636439|141666552|SUPERIORITY||Mean Difference (Final Values)|-5.0||||0.07|TWO_SIDED|95.0|-10.0|0.0|||ANCOVA|Adjusted for baseline value, age, and sex.||||0|-10|0.07
71079570|NCT02636439|141666553|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.79|TWO_SIDED|95.0|-4.4|3.3|||ANCOVA|Adjusted for baseline value, age, and sex.||||3.3|-4.4|0.79
71079571|NCT02371668|141666556|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
71117748|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-2.48||||0.731|TWO_SIDED|95.0|-16.63|11.66||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.66|-16.63|0.731
70854230|NCT02285062|141196709|SUPERIORITY|||||||0.9964||||||Obtained from CMH test adjusting for stratification factors: IPI score (2 or ≥ 3), presence of bulky disease (bulky or nonbulky), and age (\< 65 or ≥ 65)|Cochran-Mantel-Haenszel|||||||0.9964
70871976|NCT02207244|141229262|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
71079572|NCT02371668|141666557|SUPERIORITY|||||||0.114|||||||Fisher Exact|||||||0.114
71079573|NCT02371668|141666558|SUPERIORITY|||||||0.4989|||||||Wilcoxon (Mann-Whitney)|||||||0.4989
71079574|NCT02371668|141666559|SUPERIORITY|||||||0.1412|||||||Wilcoxon (Mann-Whitney)|||||||0.1412
71079575|NCT02371668|141666560|SUPERIORITY|||||||0.137|||||||Fisher Exact|||||||0.137
71079576|NCT02371668|141666561|SUPERIORITY|||||||0.2445|||||||Wilcoxon (Mann-Whitney)|||||||0.2445
71079577|NCT02371668|141666562|SUPERIORITY|||||||0.045|||||||Fisher Exact|||||||0.045
71079578|NCT02371668|141666563|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||||||0.230
71079579|NCT02371668|141666564|SUPERIORITY|||||||0.646|||||||Fisher Exact|||||||0.646
71079580|NCT00762034|141666565|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.94896|TWO_SIDED|95.0|0.86|1.16|||Log Rank|||||1.16|0.86|0.94896
71079581|NCT00762034|141666566|SUPERIORITY_OR_OTHER|||||||0.72997||95.0|||||Fisher Exact|||||||0.72997
71079582|NCT00762034|141666567|SUPERIORITY_OR_OTHER|||||||0.20892|||||||Fisher Exact|||||||0.20892
71079583|NCT00762034|141666568|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.01206|TWO_SIDED|95.0|0.71|0.96|||Log Rank|||||0.96|0.71|0.01206
71079584|NCT00762034|141666569|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.006|TWO_SIDED|95.0|0.67|0.94|||Log Rank|||||0.94|0.67|0.006
71079585|NCT00762034|141666574|SUPERIORITY_OR_OTHER|||||||0.667||95.0||||Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.|Mixed Models Analysis|||||||0.667
71079586|NCT00762034|141666575|SUPERIORITY_OR_OTHER|||||||0.815||95.0||||p-value for FACT-L Total; Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.|Mixed Models Analysis|||||||0.815
71079587|NCT00762034|141666575|SUPERIORITY_OR_OTHER|||||||0.978||95.0||||p-value for FACT-L TOI; Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.|Mixed Models Analysis|||||||0.978
71079588|NCT00762034|141666576|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value for FACT/GOG-Ntx Total; Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
71079589|NCT00762034|141666576|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value for FACT/GOG-Ntx TOI; Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
71079590|NCT00762034|141666590|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|95.0|0.338|0.681||p-value was not adjusted for multiple comparisons.|Regression, Cox|||||0.681|0.338|<0.001
70942145|NCT00043186|141384459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.63|||<|0.001||95.0|6.02|9.24|||ANCOVA|||||9.24|6.02|<0.001
71079591|NCT00762034|141666591|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.927||||0.673|TWO_SIDED|95.0|0.654|1.316||p-value is for TS Cytoplasm Positive (H score \> 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.316|0.654|0.673
71079592|NCT00762034|141666591|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.521||||0.287|TWO_SIDED|95.0|0.157|1.729||p-value is for TS Cytoplasm Negative (H score = 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.729|0.157|0.287
71079593|NCT00762034|141666591|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.759||||0.2|TWO_SIDED|95.0|0.498|1.157||p-value is for TS Nucleus Positive (H score \> 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.157|0.498|0.2
71079594|NCT00762034|141666591|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.969||||0.915|TWO_SIDED|95.0|0.54|1.738||p-value is for TS Nucleus Negative (H score = 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.738|0.540|0.915
71079595|NCT00762034|141666592|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.891|TWO_SIDED|95.0|0.622|1.511||p-value for FR-α Cytoplasm Positive (H score \> 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.511|0.622|0.891
71079596|NCT00762034|141666592|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.592||||0.06|TWO_SIDED|95.0|0.342|1.023||p-value for FR-α Cytoplasm Negative (H score = 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.023|0.342|0.060
71079597|NCT00762034|141666592|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.905|TWO_SIDED|95.0|0.49|1.88||p-value for FR-α Membrane Positive (H score \> 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.880|0.490|0.905
71079598|NCT00762034|141666592|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.859||||0.455|TWO_SIDED|95.0|0.575|1.281||p-value for FR-α Membrane Negative (H score = 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.281|0.575|0.455
71079599|NCT04656301|141666599|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|degrees of freedom = 1.92||||||<0.001
71079600|NCT00909220|141666626|SUPERIORITY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.06||0.05|TWO_SIDED|95.0|0.27|0.49|||ANCOVA|||ANCOVA comparing groups (HEA v MDD), controlling for baseline depression (IDS-C score at week 0) to estimate depression at the end of treatment (IDS-C score at week 16).||0.49|0.27|0.05
71079601|NCT00909220|141666627|SUPERIORITY|ANCOVA|Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.07|<|0.05|TWO_SIDED|95.0|0.31|0.59|||ANCOVA|||ANCOVA comparing groups (HEA v MDD), controlling for baseline depression (IDS-SR score at week 0) to estimate depression at the end of treatment (IDS-SR score at week 16).||0.59|0.31|<0.05
71079602|NCT00909220|141666628|OTHER|Multiple regression analyses|beta|0.43|STANDARD_ERROR_OF_MEAN|6.75||0.02|TWO_SIDED|||||p \<0.05 a priori threshold for statistical significance.|Regression, Linear|||||||.02
71079603|NCT00909220|141666629|OTHER|Hierarchical linear modeling (HLM) , an ordinary least square (OLS) regression-based analysis.|Slope|2.58|STANDARD_ERROR_OF_MEAN|0.75|<|0.05|TWO_SIDED|95.0|1.22|2.77||The variation of slopes among participants for each variable were calculated. If significant, a second level of analysis focused on predictors of the variation was conducted.|Regression, Logistic|df = 31||A two-level hierarchical linear model assessing the effects of negativity bias and positivity offset at pre-treatment on the rate of depression severity (IDS-SR) over 16 weeks of treatment (time). First level units were 'weeks in BA treatment', with participants limited to those who attended five or more therapy sessions, resulting in a total of 421 treatment weeks for analysis. Second-level units were the 'subjects entering BA treatment'.||2.77|1.22|<0.05
71079604|NCT02187029|141666650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-52.55|||||TWO_SIDED|90.0|-56.32|-48.78|||Bayesian ANCOVA|||||-48.780|-56.320|
71079605|NCT02187029|141666650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-66.31|||||TWO_SIDED|90.0|-71.31|-61.54|||Bayesian ANCOVA|||||-61.540|-71.310|
71079606|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||||90.0|-0.55|-0.06|||Mixed Models Analysis|||Day 1, Hour 1||-0.06|-0.55|
71079607|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.95|-0.28|||Mixed Models Analysis|||Day 1, Hour 2||-0.28|-0.95|
71079608|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|-1.52|-1.16|||Mixed Models Analysis|||Day 1, Hour 4||-1.16|-1.52|
71079609|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.86|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-2.38|-1.33|||Mixed Models Analysis|||Day 1, Hour 8||-1.33|-2.38|
71079610|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.83|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-2.18|-1.48|||Mixed Models Analysis|||Day 1, Hour 12||-1.48|-2.18|
71079611|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.74|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-2.11|-1.37|||Mixed Models Analysis|||Day 1, Hour 24||-1.37|-2.11|
71079612|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.48|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-2.89|-2.06|||Mixed Models Analysis|||Day 3||-2.06|-2.89|
71079613|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.75|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|-3.29|-2.2|||Mixed Models Analysis|||Day 7, pre-dose||-2.20|-3.29|
71117749|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-22.63||||0.024|TWO_SIDED|95.0|-39.97|-5.29||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-5.29|-39.97|0.024
71117750|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-26.87||||0.009|TWO_SIDED|95.0|-44.12|-9.62||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-9.62|-44.12|0.009
70854231|NCT02285062|141196710|SUPERIORITY||Hazard Ratio (HR)|0.776||||0.2143|TWO_SIDED|95.0|0.521|1.157|||Log Rank|Stratified by: IPI score (2 or ≥ 3), presence or absence of bulky disease (diameter of the lesion ≥ 7 cm or \< 7 cm), and age (\< 65 or ≥ 65 years).|HR was derived from COX model adjusting for the 3 stratification factors mentioned above.|||1.157|0.521|0.2143
70854232|NCT02285062|141196711|SUPERIORITY||Hazard Ratio (HR)|1.167||||0.315||95.0|0.856|1.59|||Log Rank|Stratified by: IPI score (2 or ≥ 3), presence or absence of bulky disease (diameter of the lesion ≥ 7 cm or \< 7 cm), and age (\< 65 or ≥ 65 years).|HR is derived from Cox model|||1.590|0.856|0.3150
70942146|NCT00043186|141384460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.94||||0.002||95.0|1.86|8.02|||ANCOVA|||||8.02|1.86|0.002
70871977|NCT02207244|141229263|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
71117751|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-30.76||||0.003|TWO_SIDED|95.0|-48.36|-13.16||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-13.16|-48.36|0.003
71117752|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-27.26||||0.007|TWO_SIDED|95.0|-44.51|-10.0||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-10.00|-44.51|0.007
71117753|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|4.66||||0.516|TWO_SIDED|95.0|-9.5|18.82||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.82|-9.50|0.516
71117754|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|0.55||||0.939|TWO_SIDED|95.0|-13.63|14.72||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.72|-13.63|0.939
71117755|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-4.53||||0.536|TWO_SIDED|95.0|-18.86|9.8||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.80|-18.86|0.536
71117756|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-15.81||||0.107|TWO_SIDED|95.0|-33.02|1.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.41|-33.02|0.107
71117757|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-23.71||||0.019|TWO_SIDED|95.0|-40.91|-6.51||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-6.51|-40.91|0.019
71117758|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-28.44||||0.006|TWO_SIDED|95.0|-45.99|-10.88||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-10.88|-45.99|0.006
71117759|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-25.04||||0.012|TWO_SIDED|95.0|-42.23|-7.85||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-7.85|-42.23|0.012
71117760|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|9.16||||0.195|TWO_SIDED|95.0|-4.75|23.08||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||23.08|-4.75|0.195
71117761|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.48||||0.835|TWO_SIDED|95.0|-12.54|15.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.50|-12.54|0.835
71117762|NCT01559259|141740590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-4.41||||0.542|TWO_SIDED|95.0|-18.61|9.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.79|-18.61|0.542
71117763|NCT01559259|141740591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|||<|0.001|TWO_SIDED|95.0|0.79|1.01||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||1.01|0.79|<0.001
70942147|NCT00043186|141384460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.677||95.0|-4.1|2.68|||ANCOVA|||||2.68|-4.10|0.677
70942148|NCT00043186|141384460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.66||||0.001||95.0|3.14|10.18|||ANCOVA|||||10.18|3.14|0.001
71117764|NCT01559259|141740591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.83|||<|0.001|TWO_SIDED|95.0|0.79|1.01||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||1.01|0.79|< 0.001
71117765|NCT01559259|141740591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.86|||<|0.001|TWO_SIDED|95.0|0.73|0.99||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||0.99|0.73|< 0.001
71117766|NCT01559259|141740591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8|||<|0.001|TWO_SIDED|95.0|0.65|0.95||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||0.95|0.65|< 0.001
71117767|NCT01559259|141740591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15||||0.174|TWO_SIDED|95.0|-0.07|0.37||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||0.37|-0.07|0.174
71117768|NCT01559259|141740591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04||||0.722|TWO_SIDED|95.0|-0.18|0.26||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||0.26|-0.18|0.722
71117769|NCT01559259|141740591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1||||0.365|TWO_SIDED|95.0|-0.32|0.11||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||0.11|-0.32|0.365
71117770|NCT05425732|141740592|OTHER|Miettinen \& Nurminen method|Difference in Percent|-0.9|||||TWO_SIDED|96.0|-2.8|1.1|||||V116 minus PCV20|Injection site erythema: estimated difference in percent||1.1|-2.8|
71117771|NCT05425732|141740592|OTHER|Miettinen \& Nurminen method|Difference in Percent|-12.2|||||TWO_SIDED|95.0|-16.2|-8.2|||||V116 minus PCV20|Injection site pain: estimated difference in percent||-8.2|-16.2|
71117772|NCT05425732|141740592|OTHER|Miettinen \& Nurminen method|Difference in Percent|-2.3|||||TWO_SIDED|95.0|-4.4|-0.2|||||V116 minus PCV20|Injection site swelling: estimated difference in percent||-0.2|-4.4|
71117773|NCT05425732|141740592|OTHER|Miettinen \& Nurminen method|Difference in Percent|2.5|||||TWO_SIDED|95.0|-6.6|10.3|||||V116 minus PCV20|Injection site erythema: estimated difference in percent||10.3|-6.6|
71117774|NCT05425732|141740592|OTHER|Miettinen \& Nurminen method|Difference in Percent|-2.5|||||TWO_SIDED|95.0|-12.7|8.6|||||V116 minus PCV20|Injection site pain: estimated difference in percent||8.6|-12.7|
71117775|NCT05425732|141740592|OTHER|Miettinen \& Nurminen method|Difference in Percent|0.0|||||TWO_SIDED|95.0|-9.2|7.9|||||V116 minus PCV20|Injection site swelling: estimated difference in percent||7.9|-9.2|
71117776|NCT05425732|141740593|OTHER|Miettinen \& Nurminen method|Difference in Percent|0.6|||||TWO_SIDED|95.0|-2.7|3.8|||||V116 minus PCV20|Fatigue: estimated difference in percent||3.8|-2.7|
71117777|NCT05425732|141740593|OTHER|Miettinen \& Nurminen method|Difference in Percent|-1.5|||||TWO_SIDED|95.0|-4.1|1.2|||||V116 minus PCV20|Headache: estimated difference in percent||1.2|-4.1|
70871978|NCT02207244|141229264|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||p value is based on ANOVA model stratified by investigator site (pooled).||||< 0.001
70942149|NCT00043186|141384460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.29|||<|0.001||95.0|5.26|11.33|||ANCOVA|||||11.33|5.26|<0.001
70942150|NCT00043186|141384460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.5|||<|0.001||95.0|3.59|9.41|||ANCOVA|||||9.41|3.59|<0.001
70942151|NCT00043186|141384460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.33||||0.047||95.0|0.61|8.05|||ANCOVA|||||8.05|0.61|0.047
70942152|NCT00043186|141384460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.94||||0.003||95.0|2.53|9.36|||ANCOVA|||||9.36|2.53|0.003
70942153|NCT00043186|141384460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.97||||0.001||95.0|3.28|10.66|||ANCOVA|||||10.66|3.28|0.001
70942154|NCT00043186|141384461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.69|||<|0.001||95.0|2.97|6.41|||ANCOVA|||||6.41|2.97|<0.001
70942155|NCT00043186|141384461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.16||||0.015||95.0|0.43|3.89|||ANCOVA|||||3.89|0.43|0.015
70942156|NCT00043186|141384461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.52|||<|0.001||95.0|6.74|10.3|||ANCOVA|||||10.30|6.74|<0.001
70942157|NCT00043186|141384461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.58|||<|0.001||95.0|7.95|11.21|||ANCOVA|||||11.21|7.95|<0.001
70942158|NCT00043186|141384461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.34|||<|0.001||95.0|6.7|9.99|||ANCOVA|||||9.99|6.70|<0.001
70942159|NCT00043186|141384461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.38|||<|0.001||95.0|5.45|9.31|||ANCOVA|||||9.31|5.45|<0.001
70942160|NCT00043186|141384461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.55|||<|0.001||95.0|5.72|9.38|||ANCOVA|||||9.38|5.72|<0.001
70942161|NCT00043186|141384461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.97|||<|0.001||95.0|7.23|10.72|||ANCOVA|||||10.72|7.23|<0.001
70942162|NCT00043186|141384462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44||||0.033||95.0|0.11|2.76|||ANCOVA|||||2.76|0.11|0.033
70942163|NCT00043186|141384462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.06|||<|0.001||95.0|1.69|4.42|||ANCOVA|||||4.42|1.69|<0.001
70942164|NCT00043186|141384462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.04|||<|0.001||95.0|1.68|4.4|||ANCOVA|||||4.40|1.68|<0.001
70942165|NCT00043186|141384462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.26|||<|0.001||95.0|1.94|4.57|||ANCOVA|||||4.57|1.94|<0.001
70942166|NCT00043186|141384462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.91|||<|0.001||95.0|1.6|4.21|||ANCOVA|||||4.21|1.60|<0.001
70942167|NCT00043186|141384462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.07|||<|0.001||95.0|1.65|4.49|||ANCOVA|||||4.49|1.65|<0.001
70942168|NCT00043186|141384462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.37|||<|0.001||95.0|0.99|3.76|||ANCOVA|||||3.76|0.99|<0.001
70942169|NCT00043186|141384462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.86|||<|0.001||95.0|1.47|4.24|||ANCOVA|||||4.24|1.47|<0.001
70942170|NCT00043186|141384463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.99||||0.009||95.0|0.49|3.49|||ANCOVA|||||3.49|0.49|0.009
70942171|NCT00043186|141384463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.58|||<|0.001||95.0|2.06|5.1|||ANCOVA|||||5.10|2.06|<0.001
70942172|NCT00043186|141384463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.26|||<|0.001||95.0|2.73|5.78|||ANCOVA|||||5.78|2.73|<0.001
70942173|NCT00043186|141384463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.09|||<|0.001||95.0|2.55|5.62|||ANCOVA|||||5.62|2.55|<0.001
70942174|NCT00043186|141384463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.67|||<|0.001||95.0|3.23|6.11|||ANCOVA|||||6.11|3.23|<0.001
70942175|NCT00043186|141384463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.26|||<|0.001||95.0|3.78|6.73|||ANCOVA|||||6.73|3.78|<0.001
70942176|NCT00043186|141384463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.08|||<|0.001||95.0|2.48|5.68|||ANCOVA|||||5.68|2.48|<0.001
70942177|NCT00043186|141384463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.39|||<|0.001||95.0|1.86|4.93|||ANCOVA|||||4.93|1.86|<0.001
70942178|NCT00043186|141384464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.69||||0.002||95.0|1.01|4.38|||ANCOVA|||||4.38|1.01|0.002
70942179|NCT00043186|141384464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.77|||<|0.001||95.0|2.14|5.39|||ANCOVA|||||5.39|2.14|<0.001
70942180|NCT00043186|141384464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.56|||<|0.001||95.0|3.87|7.26|||ANCOVA|||||7.26|3.87|<0.001
70942181|NCT00043186|141384464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.33|||<|0.001||95.0|4.75|7.92|||ANCOVA|||||7.92|4.75|<0.001
70942182|NCT00043186|141384464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.73|||<|0.001||95.0|4.12|7.33|||ANCOVA|||||7.33|4.12|<0.001
70942183|NCT00043186|141384464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|||<|0.001||95.0|2.89|6.5|||ANCOVA|||||6.50|2.89|<0.001
70942184|NCT00043186|141384464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|||<|0.001||95.0|2.92|6.49|||ANCOVA|||||6.49|2.92|<0.001
70942185|NCT00043186|141384464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.63|||<|0.001||95.0|3.96|7.3|||ANCOVA|||||7.30|3.96|<0.001
70942186|NCT00043186|141384465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.27||||0.496||95.0|-7.16|13.7|||ANCOVA|||||13.7|-7.16|0.496
70942187|NCT00043186|141384465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.6||||0.527||95.0|-6.38|19.59|||ANCOVA|||||19.59|-6.38|0.527
70942188|NCT00043186|141384465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.72||||0.503||95.0|-2.9|14.33|||ANCOVA|||||14.33|-2.90|0.503
70942189|NCT00043186|141384465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.68||||0.527||95.0|-6.54|11.89|||ANCOVA|||||11.89|-6.54|0.527
70942190|NCT00043186|141384465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.41||||0.503||95.0|-2.19|17.01|||ANCOVA|||||17.01|-2.19|0.503
70942191|NCT00043186|141384465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.59||||0.503||95.0|-1.85|17.03|||ANCOVA|||||17.03|-1.85|0.503
70942192|NCT00043186|141384465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.18||||0.503||95.0|-2.45|16.81|||ANCOVA|||||16.81|-2.45|0.503
70942193|NCT00043186|141384465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.88||||0.233||95.0|0.78|14.97|||ANCOVA|||||14.97|0.78|0.233
70942194|NCT00043186|141384466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.41|||<|0.001||95.0|4.48|8.34|||ANCOVA|||||8.34|4.48|<0.001
70942195|NCT00043186|141384466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.44|||<|0.001||95.0|4.19|8.7|||ANCOVA|||||8.70|4.19|<0.001
70942196|NCT00043186|141384466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.09|||<|0.001||95.0|3.91|8.26|||ANCOVA|||||8.26|3.91|<0.001
70942197|NCT00043186|141384466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.72|||<|0.001||95.0|3.7|7.73|||ANCOVA|||||7.73|3.70|<0.001
70942198|NCT00043186|141384466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.054||95.0|-0.04|4.04|||ANCOVA|||||4.04|-0.04|0.054
70942199|NCT00043186|141384466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.74|||<|0.001||95.0|1.71|5.77|||ANCOVA|||||5.77|1.71|<0.001
70942200|NCT00043186|141384466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.05|||<|0.001||95.0|4.0|8.1|||ANCOVA|||||8.10|4.00|<0.001
70942201|NCT00043186|141384466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.39|||<|0.001||95.0|4.49|8.28|||ANCOVA|||||8.28|4.49|<0.001
70942202|NCT00043186|141384467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3||||0.001||95.0|1.09|3.51|||ANCOVA|||||3.51|1.09|0.001
70942203|NCT00043186|141384467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.73||||0.005||95.0|0.52|2.93|||ANCOVA|||||2.93|0.52|0.005
70942204|NCT00043186|141384467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.004||95.0|0.74|3.25|||ANCOVA|||||3.25|0.74|0.004
70942205|NCT00043186|141384467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.72|||<|0.001||95.0|1.54|3.91|||ANCOVA|||||3.91|1.54|<0.001
70942206|NCT00043186|141384467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77||||0.202||95.0|-0.41|1.95|||ANCOVA|||||1.95|-0.41|0.202
70942207|NCT00043186|141384467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.95|||<|0.001||95.0|1.65|4.26|||ANCOVA|||||4.26|1.65|<0.001
70942208|NCT00043186|141384467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.02||||0.004||95.0|0.78|3.26|||ANCOVA|||||3.26|0.78|0.004
70942209|NCT00043186|141384467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03||||0.004||95.0|0.8|3.27|||ANCOVA|||||3.27|0.80|0.004
70942210|NCT00043186|141384468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.14|||<|0.001||95.0|1.71|4.56|||ANCOVA|||||4.56|1.71|<0.001
70942211|NCT00043186|141384468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4|||<|0.001||95.0|2.95|5.84|||ANCOVA|||||5.84|2.95|<0.001
70942212|NCT00043186|141384468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.64|||<|0.001||95.0|3.19|6.09|||ANCOVA|||||6.09|3.19|<0.001
70942213|NCT00043186|141384468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.22|||<|0.001||95.0|2.85|5.58|||ANCOVA|||||5.58|2.85|<0.001
70942214|NCT00043186|141384468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.53|||<|0.001||95.0|1.13|3.94|||ANCOVA|||||3.94|1.13|<0.001
70942215|NCT00043186|141384468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.09|||<|0.001||95.0|4.53|7.64|||ANCOVA|||||7.64|4.53|<0.001
70942216|NCT00043186|141384468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.55|||<|0.001||95.0|3.12|5.98|||ANCOVA|||||5.98|3.12|<0.001
70942217|NCT00043186|141384468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.23|||<|0.001||95.0|2.76|5.69|||ANCOVA|||||5.69|2.76|<0.001
70942218|NCT00043186|141384469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.16|||<|0.001||95.0|3.63|8.68|||ANCOVA|||||8.68|3.63|<0.001
70942219|NCT00043186|141384469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32||||0.275||95.0|-1.06|3.7|||ANCOVA|||||3.7|-1.06|0.275
70942220|NCT00043186|141384469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2||||0.005||95.0|1.65|6.75|||ANCOVA|||||6.75|1.65|0.005
70942221|NCT00043186|141384469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.41||||0.002||95.0|2.07|6.75|||ANCOVA|||||6.75|2.07|0.002
70942222|NCT00043186|141384469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.65||||0.009||95.0|1.25|6.05|||ANCOVA|||||6.05|1.25|0.009
70942223|NCT00043186|141384469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.95||||0.009||95.0|1.22|6.68|||ANCOVA|||||6.68|1.22|0.009
70942224|NCT00043186|141384469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.65||||0.003||95.0|2.05|7.24|||ANCOVA|||||7.24|2.05|0.003
70942225|NCT00043186|141384469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.75||||0.001||95.0|2.28|7.22|||ANCOVA|||||7.22|2.28|0.001
70942226|NCT00043186|141384470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.18||||0.949||95.0|-8.73|13.1|||ANCOVA|||||13.10|-8.73|0.949
70942227|NCT00043186|141384470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3||||0.949||95.0|-2.7|9.31|||ANCOVA|||||9.31|-2.70|0.949
70942228|NCT00043186|141384470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24||||0.709||95.0|-6.81|9.29|||ANCOVA|||||9.29|-6.81|0.709
70942229|NCT00043186|141384470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.36||||0.949||95.0|-8.55|3.83|||ANCOVA|||||3.83|-8.55|0.949
70942230|NCT00043186|141384470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1||||0.949||95.0|-4.51|8.72|||ANCOVA|||||8.72|-4.51|0.949
70942231|NCT00043186|141384470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.23||||0.484||95.0|-0.83|15.3|||ANCOVA|||||15.3|-0.83|0.484
70942232|NCT00043186|141384470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.44||||0.949||95.0|-3.77|8.66|||ANCOVA|||||8.66|-3.77|0.949
70942233|NCT00043186|141384470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.949||95.0|-10.82|11.4|||ANCOVA|||||11.40|-10.82|0.949
70942234|NCT00043186|141384471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.02|||<|0.001||95.0|4.35|9.69|||ANCOVA|||||9.69|4.35|<0.001
70942235|NCT00043186|141384471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.25||||0.092||95.0|-0.37|4.87|||ANCOVA|||||4.87|-0.37|0.092
70942236|NCT00043186|141384471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.22|||<|0.001||95.0|3.5|8.94|||ANCOVA|||||8.94|3.50|<0.001
70942237|NCT00043186|141384471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.97|||<|0.001||95.0|3.51|8.43|||ANCOVA|||||8.43|3.51|<0.001
70942238|NCT00043186|141384471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.96|||<|0.001||95.0|3.44|8.48|||ANCOVA|||||8.48|3.44|<0.001
70942239|NCT00043186|141384471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.29|||<|0.001||95.0|3.25|9.34|||ANCOVA|||||9.34|3.25|<0.001
70942240|NCT00043186|141384471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.91|||<|0.001||95.0|3.13|8.7|||ANCOVA|||||8.70|3.13|<0.001
70942241|NCT00043186|141384471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.22|||<|0.001||95.0|3.58|8.87|||ANCOVA|||||8.87|3.58|<0.001
70942242|NCT00043186|141384472|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942243|NCT00043186|141384472|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942244|NCT00043186|141384472|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942245|NCT00043186|141384472|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942246|NCT00043186|141384472|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942247|NCT00043186|141384472|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942248|NCT00043186|141384472|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942249|NCT00043186|141384472|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70854233|NCT00821509|141196720|SUPERIORITY_OR_OTHER||ratio of proportions|1.03||||0.004|||||||proportion test|The test was carried out using the proportions calculated from the number of sick-leave episodes over the number o total follow-up weeks in each arm||According to the null hypothesis the proportion of weeks with an onset of days-off period in neither of the intervention arms was different from that of control. No in advance power calculations were done.||||0.004
70942250|NCT00043186|141384473|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942251|NCT00043186|141384473|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942252|NCT00043186|141384473|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942253|NCT00043186|141384473|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942254|NCT00043186|141384473|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
70942255|NCT00043186|141384473|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942256|NCT00043186|141384473|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942257|NCT00043186|141384473|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942258|NCT00043186|141384474|SUPERIORITY_OR_OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|||||||0.049
70942259|NCT00043186|141384474|SUPERIORITY_OR_OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
70942260|NCT00043186|141384474|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942261|NCT00043186|141384474|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942262|NCT00043186|141384474|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942263|NCT00043186|141384474|SUPERIORITY_OR_OTHER|||||||0.146|||||||Wilcoxon (Mann-Whitney)|||||||0.146
70942264|NCT00043186|141384474|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
70942265|NCT00043186|141384474|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942266|NCT00043186|141384475|SUPERIORITY_OR_OTHER|||||||0.061|||||||Wilcoxon (Mann-Whitney)|||||||0.061
70942267|NCT00043186|141384475|SUPERIORITY_OR_OTHER|||||||0.058|||||||Wilcoxon (Mann-Whitney)|||||||0.058
70942268|NCT00043186|141384475|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
70942269|NCT00043186|141384475|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942270|NCT00043186|141384475|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942271|NCT00043186|141384475|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
70942272|NCT00043186|141384475|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
70942273|NCT00043186|141384475|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
70942274|NCT00043186|141384476|SUPERIORITY_OR_OTHER|||||||0.142|||||||Wilcoxon (Mann-Whitney)|||||||0.142
70942275|NCT00043186|141384476|SUPERIORITY_OR_OTHER|||||||0.218|||||||Wilcoxon (Mann-Whitney)|||||||0.218
70942276|NCT00043186|141384476|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
70942277|NCT00043186|141384476|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.010
70942278|NCT00043186|141384476|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70942279|NCT00043186|141384476|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.010
70942280|NCT00043186|141384476|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
70942281|NCT00043186|141384476|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
70942282|NCT05012280|141384493|SUPERIORITY||Odds Ratio (OR)|1.221||||0.115|TWO_SIDED|95.0|0.953|1.564||only one primary endpoint, p value not adjusted for multiple comparisons. A priori treshold or statistical significance: p=0.05|Regression, Logistic|conditional logistic regression for matched case control||||1.564|0.953|0.1150
70942283|NCT05012280|141384493|SUPERIORITY||Odds Ratio (OR)|1.221||||0.12|TWO_SIDED|95.0|0.953|1.564|||Regression, Logistic|conditional logistic regression for matched case control study.||||1.564|0.953|0.12
70942284|NCT03245762|141384519|SUPERIORITY||Odds Ratio (OR)|0.9||||0.93|TWO_SIDED||||||Ordinal Categorical Analysis|||||||0.930
70942285|NCT00377312|141384556|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||The reported p-value corresponds to the increase over time for the PTH 2 pmol group.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.0001
70942286|NCT00377312|141384557|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||The reported p-value corresponds to the increase over time for the PTH 2 pmol group.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.0001
70942287|NCT00377312|141384558|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds to change over time for the PTH 2 and PTH 4 pmol groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>0.05
70942288|NCT00377312|141384559|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.01|TWO_SIDED|||||The reported p-value corresponds to change over time for the PTH 2 and PTH 4 pmol groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||.01
70942289|NCT00377312|141384560|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.05|TWO_SIDED|||||the reported p-values correspond to the decrease compared to baseline in all arms/groups at Days 2-8|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.05
70942290|NCT00377312|141384561|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.002|TWO_SIDED|||||the reported p-value corresponds to the increase compared to baseline over time (days 2-8) in the PTH 2 pmol group|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||.002
70942291|NCT00377312|141384563|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.61|TWO_SIDED|||||The reported p-value corresponds to change over time for the PTH 2 and PTH 4 pmol groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||.61
70871979|NCT02207244|141229265|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
70942292|NCT00377312|141384564|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.008|TWO_SIDED|||||The reported p-value corresponds to the % increase compared to baseline in all Arms/groups on Days 2-8|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.008
70942293|NCT00377312|141384564|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds the the % change from baseline at follow-up in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>0.05
70942294|NCT00377312|141384565|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||The reported p-value corresponds to % change (increase) from baseline in all Arms/groups at Days 2-8.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.0001
71079614|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-3.39|-2.21|||Mixed Models Analysis|||Day 7, Hour 1||-2.21|-3.39|
70942295|NCT00377312|141384565|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds the the % change from baseline at follow-up in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>0.05
70942296|NCT00377312|141384566|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||the reported p-value corresponds to % decrease compared to baseline at Days 2-8 in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.0001
70854234|NCT00821509|141196721|SUPERIORITY_OR_OTHER||ratio of proportions|0.933||||0.04|||||||proportion test|||According to the null hypothesis the proportion of weeks with an onset of an infectious disease period in neither of the intervention arms was different from that of control. No in advance power calculations were done.||||0.04
71079615|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.06|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-3.72|-2.41|||Mixed Models Analysis|||Day 7, Hour 2||-2.41|-3.72|
71117778|NCT05425732|141740593|OTHER|Miettinen \& Nurminen method|Difference in Percent|-0.8|||||TWO_SIDED|96.0|-2.8|1.2|||||V116 minus PCV20|Myalgia: estimated difference in percent||1.2|-2.8|
71117779|NCT05425732|141740593|OTHER|Miettinen \& Nurminen method|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.0|1.0|||||V116 minus PCV20|Pyrexia: estimated difference in percent||1.0|-1.0|
71117780|NCT05425732|141740593|OTHER|Miettinen \& Nurminen method|Difference in Percent|6.5|||||TWO_SIDED|95.0|-5.3|17.6|||||V116 minus PCV20|Fatigue: estimated difference in percent||17.6|-5.3|
71117781|NCT05425732|141740593|OTHER|Miettinen \& Nurminen method|Difference in Percent|5.5|||||TWO_SIDED|5.0|-5.5|15.5|||||V116 minus PCV20|Headache: estimated difference in percent||15.5|-5.5|
71117782|NCT05425732|141740593|OTHER|Miettinen \& Nurminen method|Difference in Percent|2.5|||||TWO_SIDED|95.0|-6.8|10.6|||||V116 minus PCV20|Myalgia: estimated difference in percent||10.6|-6.8|
71117783|NCT05425732|141740593|OTHER|Miettinen \& Nurminen method|Difference in Percent|2.5|||||TWO_SIDED|95.0|-2.2|6.2|||||V116 minus PCV20|Pyrexia: estimated difference in percent||6.2|-2.2|
71117784|NCT05425732|141740595|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.55|||<|0.001|TWO_SIDED|95.0|1.4|1.72||1-sided|cLDA model||V116/PCV20|Serotype 3: V116/PCV20 GMT Ratio||1.72|1.40|<0.001
71117785|NCT05425732|141740595|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.77|||<|0.001|TWO_SIDED|95.0|0.68|0.88|||cLDA model||V116/PCV20|Serotype 6A: V116/PCV20 GMT Ratio||0.88|0.68|<0.001
71117786|NCT05425732|141740595|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.06|||<|0.001|TWO_SIDED|95.0|0.95|1.18|||cLDA model||V116/PCV20|Serotype 7F: V116/PCV20 GMT Ratio||1.18|0.95|<0.001
71117787|NCT05425732|141740595|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.38|||<|0.001|TWO_SIDED|95.0|1.25|1.53|||cLDA model||V116/PCV20|Serotype 8: V116/PCV20 GMT Ratio||1.53|1.25|<0.001
71117788|NCT05425732|141740595|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.75|0.93|||cLDA model||V116/PCV20|Serotype 10A: V116/PCV20 GMT Ratio||0.93|0.75|<0.001
71117789|NCT05425732|141740595|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.54|||<|0.001|TWO_SIDED|95.0|1.39|1.72|||cLDA model||V116/PCV20|Serotype 11A: V116/PCV20 GMT Ratio||1.72|1.39|<0.001
71117790|NCT05425732|141740595|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.06|||<|0.001|TWO_SIDED|95.0|0.92|1.21|||cLDA model||V116/PCV20|Serotype 12F: V116/PCV20 GMT Ratio||1.21|0.92|<0.001
71117791|NCT05425732|141740595|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.76|||<|0.001|TWO_SIDED|95.0|0.69|0.84|||cLDA model||V116/PCV20|Serotype 19A: V116/PCV20 GMT Ratio||0.84|0.69|<0.001
71117792|NCT05425732|141740595|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.81|||<|0.001|TWO_SIDED|95.0|0.72|0.92|||cLDA model||V116/PCV20|Serotype 22F: V116/PCV20 GMT Ratio||0.92|0.72|<0.001
70942297|NCT00377312|141384566|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.01|TWO_SIDED|||||the reported p-value corresponds to % change from baseline at the follow-up visit in all Arms/groups|Mixed Models Analysis|the reported p-value corresponds to % change from baseline at the follow-up visit in all Arms/groups||||||.01
70942298|NCT00377312|141384567|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||the reported p-value corresponds to % change compared to baseline at Days 2-8 in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>.05
70954212|NCT00688870|141411074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.3|||||TWO_SIDED|95.0|-6.9|3.1|||Chan and Zhang|||Common serotypes - serotype 19F||3.1|-6.9|
70854235|NCT01227629|141196736|SUPERIORITY_OR_OTHER|||||||0.0357||95.0|||||Kruskal-Wallis|||Group comparison of differences from baseline to last available value||||0.0357
70854236|NCT01227629|141196737|SUPERIORITY_OR_OTHER|||||||0.26711||95.0|||||Kruskal-Wallis|||Group comparison of differences from baseline to week 12||||0.26711
70942299|NCT00382408|141384570|SUPERIORITY_OR_OTHER||vaccine efficacy (VE)|99.31|||||TWO_SIDED|95.0|96.02|99.88||||||The vaccine efficacy (VE) was defined as: VE = 1 - R, where R = P(vaccine)/P(placebo) was the relative risk of ARD attack in subjects who received vaccines compared to placebos (Blackwelder 1993). The 95% confidence interval of the VE was obtained by inverting the Chi Square method proposed by Koopman for the ratio of two binomial proportions (Koopman 1984). The goal of the analysis of efficacy was to demonstrate a VE of at least 80% with a lower 95% confidence bound at least 60%.||99.88|96.02|
70942300|NCT00382408|141384575|SUPERIORITY_OR_OTHER||vaccine efficacy (VE)|98.46|||||TWO_SIDED|95.0|95.39|99.49||||||The vaccine efficacy (VE) was defined as: VE = 1 - R, where R = P(vaccine)/P(placebo) was the relative risk of ARD attack in subjects who received vaccines compared to placebos (Blackwelder 1993). The 95% confidence interval of the VE was obtained by inverting the Chi Square method proposed by Koopman for the ratio of two binomial proportions (Koopman 1984). The goal of the analysis of efficacy was to demonstrate a VE of at least 80% with a lower 95% confidence bound at least 60%.||99.49|95.39|
70942301|NCT01066897|141384601|OTHER|||||||0.002|||||||Chi-squared|||||||.002
70942302|NCT01066897|141384602|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.368|STANDARD_DEVIATION|0.44||0.067|TWO_SIDED||||||t-test, 2 sided|One sample t-test to determine if the % change in HAMD was different from 0||For the 2 dropouts, used LOCF.||||.067
70942303|NCT03861429|141384605|SUPERIORITY||Odds Ratio (OR)|3.32||||0.105|TWO_SIDED|95.0|0.78|14.15|||Mixed Models Analysis|||Multilevel logistic regression (generalized estimating equations \[GEE\] with an autoregressive (1) working correlation matrix, logit link function) were fitted to assess the primary hypotheses. The models account for the repeated measures (3 or 4 time points), correlated, data structure per person. An additive model was conducted with contrast coding for each time point, treatment, and follow-up effects.||14.15|.78|.105
70942304|NCT03861429|141384606|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.04|TWO_SIDED|95.0|0.022|1.178|||Mixed Models Analysis||Calculation of mean differences were derived from mixed model analyses|||1.178|.022|.04
70942305|NCT03861429|141384607|SUPERIORITY||Mean Difference (Final Values)|0.29||||0.001|TWO_SIDED|95.0|0.12|0.46|||Mixed Models Analysis||Calculation of mean differences were derived from mixed model analyses|||.46|.12|.001
70942306|NCT03861429|141384608|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.001|TWO_SIDED|95.0|0.21|0.48|||Mixed Models Analysis||Calculation of mean differences were derived from mixed model analyses|||.48|.21|.001
70942307|NCT03861429|141384609|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.081|TWO_SIDED|95.0|-0.01|0.19|||Mixed Models Analysis|||||.19|-.01|.081
70942308|NCT03861429|141384610|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.033|TWO_SIDED|95.0|0.11|0.3|||Mixed Models Analysis||Calculation of mean differences were derived from mixed model analyses|||.3|.11|.033
70854237|NCT03602560|141196747|OTHER|The primary endpoint was analyzed using Cochran-Mantel-Haenszel (CMH) test adjusted for both randomization stratification variables (ALP level: \<350 U/L and 2:350 U/L; pruritus NRS: \<4 and 2:4).|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70854238|NCT03602560|141196747|OTHER|The primary endpoint was analyzed using Cochran-Mantel-Haenszel (CMH) test adjusted for both randomization stratification variables (ALP level: \<350 U/L and 2:350 U/L; pruritus NRS: \<4 and 2:4).|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70942309|NCT05372913|141384614|NON_INFERIORITY|The non-inferiority (NI) test for the secondary outcome (i.e., PHQ-8 Week 4 EOT score) was assessed using the pre-specified NI margin of 2.0. NI of W-GenZD to CBT-Lite was declared if the upper bound of the one-sided 97.5% confidence interval (CI) was less than 2.|Mean Difference (Net)|-0.67|||||TWO_SIDED|95.0|-2.3|0.96||||||||0.96|-2.30|
70942310|NCT02137239|141384650|SUPERIORITY||Incidence of Change|-1.7|||||TWO_SIDED|95.0|-18.9|16.7||||||Change in Incidence of Treatment A as compared to Treatment B at 6 Months||16.7|-18.9|
70942311|NCT02137239|141384650|SUPERIORITY||Incidence of Change|-1.0|||||TWO_SIDED|95.0|-19.2|18.9||||||Change in Incidence of Treatment A as compared to Treatment B at 12 Months||18.9|-19.2|
70942312|NCT02137239|141384650|SUPERIORITY||Incidence of Change|2.9|||||TWO_SIDED|95.0|-16.1|23.9||||||Change in Incidence of Treatment A as compared to Treatment B at 24 Months||23.9|-16.1|
70942313|NCT00139659|141384677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.034|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.08|0.011|||longitudinal data analysis model|Confidence interval of least squares (LS) mean difference (INH - SC) between annual rates of change for the two treatment groups.|Primary analysis model includes terms of Treatment, Time, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on day of randomization.|Treatment group difference (Exubera minus subcutaneous insulin): annualized rate of change over time. Longitudinal data analysis methods with random effects were used to model the pulmonary function test (PFT) measurements. Random effects included the intercept and slope with respect to time (visit); all remaining effects were fixed. The estimated rate of change over time for each treatment group was derived from this model.||0.011|-0.080|
70942314|NCT00139659|141384678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.065|0.015|||Mixed Models Analysis|||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.015|-0.065|
71079616|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|90.0|-4.03|-2.77|||Mixed Models Analysis|||Day7, Hour 4||-2.77|-4.03|
70942315|NCT00139659|141384678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.034|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.073|0.006|||Mixed Models Analysis|||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.006|-0.073|
71079617|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-3.82|-2.79|||Mixed Models Analysis|||Day 7, Hour 8||-2.79|-3.82|
70854239|NCT03602560|141196748|OTHER|Two-sided p-value for each pair-wise comparison was based on the CMH test adjusted for both randomization stratification variables (ALP level: \<350 U/L and 350 U/L; pruritus NRS: \<4 and 4). Breslow-Day test was used to check the homogeneity of treatment effects across stratum.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70942316|NCT00139659|141384678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.063|0.016|||Mixed Models Analysis|||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.016|-0.063|
71079618|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.2|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-3.72|-2.68|||Mixed Models Analysis|||Day 7, Hour 12||-2.68|-3.72|
71079619|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.81|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-3.3|-2.32|||Mixed Models Analysis|||Day 7, Hour 24||-2.32|-3.30|
71079620|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.56|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|90.0|-5.19|-3.92|||Mixed Models Analysis|||Day 11||-3.92|-5.19|
70942317|NCT00139659|141384678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.035|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.075|0.004|||Mixed Models Analysis|||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.004|-0.075|
70942318|NCT00139659|141384678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.027|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.067|0.012|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.012|-0.067|
70942319|NCT00139659|141384678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.033|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.073|0.008|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.008|-0.073|
70942320|NCT00139659|141384678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.018|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.059|0.023|||Mixed Models Analysis|||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.023|-0.059|
70942321|NCT00139659|141384678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.052|0.031|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.031|-0.052|
70942322|NCT00139659|141384678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025|STANDARD_ERROR_OF_MEAN|0.026||||90.0|-0.068|0.017|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.017|-0.068|
71079621|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.32|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-4.75|-3.88|||Mixed Models Analysis|||Day 14, pre-dose||-3.88|-4.75|
70942323|NCT00139659|141384678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.073|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.117|-0.029|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.029|-0.117|
70942324|NCT00139659|141384678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.108|-0.015|||Mixed Models Analysis|||Week 52 (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.015|-0.108|
70942325|NCT00139659|141384679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.327|STANDARD_ERROR_OF_MEAN|0.214||||90.0|-0.679|0.026|||Mixed Models Analysis|||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.026|-0.679|
70942326|NCT00139659|141384679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.378|STANDARD_ERROR_OF_MEAN|0.213||||90.0|-0.729|-0.027|||Mixed Models Analysis|||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.027|-0.729|
71079622|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.55|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-5.02|-4.08|||Mixed Models Analysis|||Day 14, Hour 1||-4.08|-5.02|
71079623|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.97|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-5.47|-4.47|||Mixed Models Analysis|||Day 14, Hour 2||-4.47|-5.47|
70942327|NCT00139659|141384679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.346|STANDARD_ERROR_OF_MEAN|0.213||||90.0|-0.696|0.004|||Mixed Models Analysis|||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.004|-0.696|
70942328|NCT00139659|141384679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.496|STANDARD_ERROR_OF_MEAN|0.213||||90.0|-0.847|-0.145|||Mixed Models Analysis|||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.145|-0.847|
71079624|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.43|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|-5.83|-5.02|||Mixed Models Analysis|||Day 14, Hour 4||-5.02|-5.83|
70942329|NCT00139659|141384679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.213||||90.0|-0.96|-0.26|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.260|-0.960|
70942330|NCT00139659|141384679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.219||||90.0|-0.721|0.001|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.001|-0.721|
70942331|NCT00139659|141384679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.291|STANDARD_ERROR_OF_MEAN|0.221||||90.0|-0.655|0.073|||Mixed Models Analysis|||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.073|-0.655|
70942332|NCT00139659|141384679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.224||||90.0|-0.788|-0.052|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.052|-0.788|
70942333|NCT00139659|141384679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.337|STANDARD_ERROR_OF_MEAN|0.231||||90.0|-0.717|0.042|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.042|-0.717|
70942334|NCT00139659|141384679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.789|STANDARD_ERROR_OF_MEAN|0.238||||90.0|-1.181|-0.397|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.397|-1.181|
70942335|NCT00139659|141384679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.786|STANDARD_ERROR_OF_MEAN|0.238||||90.0|-1.178|-0.393|||Mixed Models Analysis|||Week 52 (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.393|-1.178|
71079625|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.57|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-6.08|-5.05|||Mixed Models Analysis|||Day 14, Hour 8||-5.05|-6.08|
70942336|NCT00139659|141384682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.066|0.023|||Mixed Models Analysis|||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.023|-0.066|
70942337|NCT00139659|141384682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.044|0.044|||Mixed Models Analysis|||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.044|-0.044|
70942338|NCT00139659|141384682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.056|0.032|||Mixed Models Analysis|||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.032|-0.056|
70942339|NCT00139659|141384682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.048|0.041|||Mixed Models Analysis|||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.041|-0.048|
70942340|NCT00139659|141384682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.089|-0.001|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.001|-0.089|
71079626|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.34|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-5.86|-4.82|||Mixed Models Analysis|||Day 14, Hour 12||-4.82|-5.86|
71079627|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.65|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-5.12|-4.18|||Mixed Models Analysis|||Day 14, Hour 24||-4.18|-5.12|
70854240|NCT03602560|141196748|OTHER|Two-sided p-value for each pair-wise comparison is based on the Cochran Mantel Haenszel test adjusted for both randomization stratification variables (ALP level: \< 350 U/L and \>= 350 U/L; pruritus NRS: \< 4 and \>= 4). Breslow-Day test is used to check the homogeneity of treatment effects across stratum.||||||0.0839|||||||Cochran-Mantel-Haenszel|||||||0.0839
70942341|NCT00139659|141384682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.035|0.056|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.056|-0.035|
70942342|NCT00139659|141384682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.018|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.028|0.064|||Mixed Models Analysis|||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.064|-0.028|
70942343|NCT00139659|141384682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.051|0.041|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.041|-0.051|
70942344|NCT00139659|141384682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.022|STANDARD_ERROR_OF_MEAN|0.029||||90.0|-0.07|0.026|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.026|-0.070|
70942345|NCT00139659|141384682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.03||||90.0|-0.064|0.034|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.034|-0.064|
70942346|NCT00139659|141384682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.031||||90.0|-0.067|0.037|||Mixed Models Analysis|||Week 52 (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.037|-0.067|
71079628|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.09|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|-2.97|0.79|||Mixed Models Analysis|||Follow-up, Day 25-29||0.79|-2.97|
70854241|NCT03602560|141196749|OTHER|"Change from baseline is estimated by an analysis of covariance (ANCOVA) model with treatment group (including 3 levels:~Placebo, Initial Dose 5mg, and Initial Dose 10 mg) and randomization ALP stratification as factors, and baseline as a covariate.~The p-value for the interaction between treatment and stratum is 0.7595, hence the interaction is dropped from the model."|Risk Difference (RD)|-1.59||||0.0164|TWO_SIDED|95.0|-2.87|-0.3|||ANCOVA|||||-0.3|-2.87|0.0164
71079629|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.92|-0.32|||Mixed Models Analysis|||Day 1, Hour 1||-0.32|-0.92|
71079630|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-1.61|-0.75|||Mixed Models Analysis|||Day 1, Hour 2||-0.75|-1.61|
71079631|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.91|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|90.0|-3.14|-2.69|||Mixed Models Analysis|||Day 1, Hour 4||-2.69|-3.14|
70942347|NCT00139659|141384683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.632|STANDARD_ERROR_OF_MEAN|0.697||||90.0|-1.778|0.514|||Mixed Models Analysis|||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.514|-1.778|
70942348|NCT00139659|141384683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.668||||90.0|-1.079|1.12|||Mixed Models Analysis|||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||1.120|-1.079|
70942349|NCT00139659|141384683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.582|STANDARD_ERROR_OF_MEAN|0.679||||90.0|-0.535|1.7|||Mixed Models Analysis|||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||1.700|-0.535|
70942350|NCT00139659|141384683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.687||||90.0|-1.184|1.077|||Mixed Models Analysis|||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||1.077|-1.184|
70942351|NCT00139659|141384683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.535|STANDARD_ERROR_OF_MEAN|0.694||||90.0|-1.677|0.608|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.608|-1.677|
70942352|NCT00139659|141384683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.905|STANDARD_ERROR_OF_MEAN|0.674||||90.0|-2.014|0.203|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.203|-2.014|
70942353|NCT00139659|141384683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.212|STANDARD_ERROR_OF_MEAN|0.675||||90.0|-0.899|1.323|||Mixed Models Analysis|||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||1.323|-0.899|
70942354|NCT00139659|141384683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.683||||90.0|-1.08|1.169|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||1.169|-1.080|
70942355|NCT00139659|141384683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.694||||90.0|-1.382|0.902|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.902|-1.382|
70942356|NCT00139659|141384683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.503|STANDARD_ERROR_OF_MEAN|0.711||||90.0|-1.673|0.668|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.668|-1.673|
70942357|NCT00139659|141384697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.503|STANDARD_ERROR_OF_MEAN|0.216||||90.0|-0.858|-0.148|||Longitudinal data analysis model|Confidence interval of least squares (LS) mean difference (INH - SC) between annual rates of change for the two treatment groups.|Primary analysis model includes terms of Treatment, Time, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on day of randomization.|Treatment group difference (Exubera minus subcutaneous insulin): annualized rate of change over time. Longitudinal data analysis methods with random effects were used to model the pulmonary function test (PFT) measurements. Random effects included the intercept and slope with respect to time (visit); all remaining effects were fixed. The estimated rate of change over time for each treatment group was derived from this model.||-0.148|-0.858|
70942358|NCT00139659|141384701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.1||||90.0|-0.06|0.28|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.||0.28|-0.06|
70942359|NCT00139659|141384701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.1||||90.0|0.04|0.38|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.||0.38|0.04|
70942360|NCT00139659|141384701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.11||||90.0|-0.01|0.34|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.||0.34|-0.01|
70942361|NCT00139659|141384701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.11||||90.0|-0.03|0.32|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.||0.32|-0.03|
70942362|NCT00139659|141384701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.11||||90.0|-0.12|0.24|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.||0.24|-0.12|
71079632|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|90.0|-4.36|-3.03|||Mixed Models Analysis|||Day 1, Hour 8||-3.03|-4.36|
70942363|NCT00139659|141384701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.12||||90.0|-0.19|0.22|||Mixed Models Analysis|||Week 52 (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.||0.22|-0.19|
71079633|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.84|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-4.28|-3.4|||Mixed Models Analysis|||Day 1, Hour 12||-3.40|-4.28|
70942364|NCT00139659|141384702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.615|STANDARD_ERROR_OF_MEAN|7.874||||90.0|-2.351|23.581|||Mixed Models Analysis|Confidence interval for the LS mean of that particular treatment.||Week 6; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.||23.581|-2.351|
71079634|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.47|STANDARD_ERROR_OF_MEAN|0.26||||90.0|-3.94|-3.0|||Mixed Models Analysis|||Day 1, Hour 24||-3.00|-3.94|
70942365|NCT00139659|141384702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.942|STANDARD_ERROR_OF_MEAN|7.804||||90.0|-19.79|5.909|||Mixed Models Analysis|||Week 12; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.||5.909|-19.79|
71079635|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.76|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-5.29|-4.23|||Mixed Models Analysis|||Day 3||-4.23|-5.29|
70942366|NCT00139659|141384702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.622|STANDARD_ERROR_OF_MEAN|7.897||||90.0|-17.63|8.382|||Mixed Models Analysis|||Week 26; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.||8.382|-17.63|
70942367|NCT00139659|141384702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.828|STANDARD_ERROR_OF_MEAN|7.888||||90.0|-11.16|14.817|||Mixed Models Analysis|||Week 39; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.||14.817|-11.16|
70942368|NCT00139659|141384702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.149|STANDARD_ERROR_OF_MEAN|7.991||||90.0|-12.01|14.307|||Mixed Models Analysis|||Week 52; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.||14.307|-12.01|
70942369|NCT00139659|141384702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.247|STANDARD_ERROR_OF_MEAN|7.816||||90.0|-8.664|17.157|||Mixed Models Analysis|||Week 52 (LOCF); Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.||17.157|-8.664|
70942370|NCT00139659|141384703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|0.455||||90.0|-1.829|-0.331|||Mixed Models Analysis|||Week 1; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||-0.331|-1.829|
70942371|NCT00139659|141384703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.475|STANDARD_ERROR_OF_MEAN|0.461||||90.0|-1.233|0.284|||Mixed Models Analysis|||Week 2; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.284|-1.233|
70942372|NCT00139659|141384703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.185|STANDARD_ERROR_OF_MEAN|0.454||||90.0|-0.931|0.562|||Mixed Models Analysis|||Week 3; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.562|-0.931|
70942373|NCT00139659|141384703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.189|STANDARD_ERROR_OF_MEAN|0.449||||90.0|-0.929|0.55|||Mixed Models Analysis|||Week 4; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.550|-0.929|
71079636|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.81|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|90.0|-6.62|-5.0|||Mixed Models Analysis|||Day 7, pre-dose||-5.00|-6.62|
71079637|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.84|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|90.0|-6.72|-4.95|||Mixed Models Analysis|||Day 7, Hour 1||-4.95|-6.72|
71079638|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.18|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|90.0|-7.17|-5.19|||Mixed Models Analysis|||Day 7, Hour 2||-5.19|-7.17|
71079639|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.51|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-7.46|-5.55|||Mixed Models Analysis|||Day 7, Hour 4||-5.55|-7.46|
71079640|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.29|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|90.0|-7.07|-5.51|||Mixed Models Analysis|||Day 7, Hour 8||-5.51|-7.07|
71079641|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.24|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|90.0|-7.03|-5.44|||Mixed Models Analysis|||Day 7, Hour 12||-5.44|-7.03|
70942374|NCT00139659|141384703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.558|STANDARD_ERROR_OF_MEAN|0.447||||90.0|-1.294|0.178|||Mixed Models Analysis|||Week 6; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.178|-1.294|
70942375|NCT00139659|141384703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.748|STANDARD_ERROR_OF_MEAN|0.467||||90.0|-1.517|0.022|||Mixed Models Analysis|||Week 9; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.022|-1.517|
70942376|NCT00139659|141384703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.053|STANDARD_ERROR_OF_MEAN|0.886||||90.0|-2.51|0.405|||Mixed Models Analysis|||Week 11; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.405|-2.510|
70942377|NCT00139659|141384703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.891|STANDARD_ERROR_OF_MEAN|0.451||||90.0|-1.634|-0.149|||Mixed Models Analysis|||Week 12; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||-0.149|-1.634|
71079642|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.75|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|90.0|-6.5|-4.99|||Mixed Models Analysis|||Day 7, Hour 24||-4.99|-6.50|
71079643|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.62|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-6.59|-4.65|||Mixed Models Analysis|||Day 11||-4.65|-6.59|
70942378|NCT00139659|141384703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.453||||90.0|-1.725|-0.234|||Mixed Models Analysis|||Week 18; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||-0.234|-1.725|
70942379|NCT00139659|141384703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.663|STANDARD_ERROR_OF_MEAN|0.448||||90.0|-1.4|0.075|||Mixed Models Analysis|||Week 26; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.075|-1.400|
70942380|NCT00139659|141384703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.537|STANDARD_ERROR_OF_MEAN|0.451||||90.0|-1.279|0.205|||Mixed Models Analysis|||Week 39; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.205|-1.279|
70942381|NCT00139659|141384703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.322|STANDARD_ERROR_OF_MEAN|1.027||||90.0|-3.012|0.369|||Mixed Models Analysis|||Week 50; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.369|-3.012|
70942382|NCT00139659|141384703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.552||||90.0|-0.847|0.972|||Mixed Models Analysis|||Week 51; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.972|-0.847|
70942383|NCT00139659|141384703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.193|STANDARD_ERROR_OF_MEAN|0.469||||90.0|-0.964|0.579|||Mixed Models Analysis|||Week 52; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.579|-0.964|
70942384|NCT00139659|141384703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.526||||90.0|-1.298|0.438|||Mixed Models Analysis|||Week 52 (LOCF); adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.438|-1.298|
70942385|NCT00139659|141384711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.079|0.0|||Mixed Models Analysis|||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.000|-0.079|
71079644|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.76|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-6.42|-5.1|||Mixed Models Analysis|||Day 14, pre-dose||-5.10|-6.42|
70942386|NCT00139659|141384711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.029|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.068|0.01|||Mixed Models Analysis|||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.010|-0.068|
70942387|NCT00139659|141384711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.084|-0.006|||Mixed Models Analysis|||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.006|-0.084|
70942388|NCT00139659|141384711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.046|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.085|-0.007|||Mixed Models Analysis|||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.007|-0.085|
71079645|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.96|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|90.0|-6.67|-5.24|||Mixed Models Analysis|||Day 14, Hour 1||-5.24|-6.67|
70942389|NCT00139659|141384711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.046|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.085|-0.007|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.007|-0.085|
70942390|NCT00139659|141384711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.063|0.017|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.017|-0.063|
70942391|NCT00139659|141384711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.062|0.02|||Mixed Models Analysis|||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.020|-0.062|
70942392|NCT00139659|141384711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.055|0.027|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.027|-0.055|
70942393|NCT00139659|141384711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.026||||90.0|-0.085|0.0|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.000|-0.085|
71079646|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.14|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|90.0|-6.9|-5.38|||Mixed Models Analysis|||Day 14, Hour 2||-5.38|-6.90|
70942394|NCT00139659|141384711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.065|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.109|-0.022|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.022|-0.109|
70942395|NCT00139659|141384711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.097|-0.003|||Mixed Models Analysis|||Week 52 Last Observation Carried Forward (LOCF; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.003|-0.097|
70942396|NCT00139659|141384712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.279|STANDARD_ERROR_OF_MEAN|0.199||||90.0|-0.606|0.048|||Mixed Models Analysis|||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.048|-0.606|
71117793|NCT05425732|141740595|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.15|||<|0.001|TWO_SIDED|95.0|1.01|1.32|||cLDA model||V116/PCV20|Serotype 33F: V116/PCV20 GMT Ratio||1.32|1.01|<0.001
71117794|NCT05425732|141740595|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|4.55|||<|0.001|TWO_SIDED|95.0|4.12|5.04|||cLDA model||V116/PCV20|Serotype 9N: V116/PCV20 GMT Ratio||5.04|4.12|<0.001
71117795|NCT05425732|141740595|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|3.3|||<|0.001|TWO_SIDED|95.0|2.91|3.74|||cLDA model||V116/PCV20|Serotype 15A: V116/PCV20 GMT Ratio||3.74|2.91|<0.001
71117796|NCT05425732|141740595|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|2.03|||<|0.001|TWO_SIDED|95.0|1.77|2.34|||cLDA model||V116/PCV20|Serotype 15C: V116/PCV20 GMT Ratio||2.34|1.77|<0.001
71117797|NCT05425732|141740595|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|5.75|||<|0.001|TWO_SIDED|95.0|5.16|6.41|||cLDA model||V116/PCV20|Serotype 16F: V116/PCV20 GMT Ratio||6.41|5.16|<0.001
71117798|NCT05425732|141740595|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|16.86|||<|0.001|TWO_SIDED|95.0|14.9|19.09|||cLDA model||V116/PCV20|Serotype 17F: V116/PCV20 GMT Ratio||19.09|14.90|<0.001
71117799|NCT05425732|141740595|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|9.66|||<|0.001|TWO_SIDED|95.0|8.66|10.79|||cLDA model||V116/PCV20|Serotype 20A: V116/PCV20 GMT Ratio||10.79|8.66|<0.001
71117800|NCT05425732|141740595|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|8.1|||<|0.001|TWO_SIDED|95.0|6.86|9.55|||cLDA model||V116/PCV20|Serotype 23A: V116/PCV20 GMT Ratio||9.55|6.86|<0.001
71117801|NCT05425732|141740595|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|10.09|||<|0.001|TWO_SIDED|95.0|8.48|12.0|||cLDA model||V116/PCV20|Serotype 23B: V116/PCV20 GMT Ratio||12.00|8.48|<0.001
70942397|NCT00139659|141384712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.336|STANDARD_ERROR_OF_MEAN|0.198||||90.0|-0.661|-0.011|||Mixed Models Analysis|||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.011|-0.661|
70942398|NCT00139659|141384712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.384|STANDARD_ERROR_OF_MEAN|0.196||||90.0|-0.707|-0.061|||Mixed Models Analysis|||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.061|-0.707|
71117802|NCT05425732|141740595|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|38.71|||<|0.001|TWO_SIDED|95.0|33.87|44.25|||cLDA model||V116/PCV20|Serotype 24F: V116/PCV20 GMT Ratio||44.25|33.87|<0.001
71117803|NCT05425732|141740595|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|21.69|||<|0.001|TWO_SIDED|95.0|18.68|25.18|||cLDA model||V116/PCV20|Serotype 31: V116/PCV20 GMT Ratio||25.18|18.68|<0.001
71117804|NCT05425732|141740595|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|6.17|||<|0.001|TWO_SIDED|95.0|5.59|6.8|||cLDA model||V116/PCV20|Serotype 35B: V116/PCV20 GMT Ratio||6.80|5.59|<0.001
71117805|NCT05425732|141740596|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|44.7|||<|0.001|TWO_SIDED|95.0|40.7|48.6||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 9N: V116-PCV20 Percentage Difference||48.6|40.7|<0.001
71117806|NCT05425732|141740596|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|30.9|||<|0.001|TWO_SIDED|95.0|25.8|35.8||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 15A: V116-PCV20 Percentage Difference||35.8|25.8|<0.001
70942399|NCT00139659|141384712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.516|STANDARD_ERROR_OF_MEAN|0.198||||90.0|-0.842|-0.191|||Mixed Models Analysis|||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.191|-0.842|
70942400|NCT00139659|141384712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.474|STANDARD_ERROR_OF_MEAN|0.196||||90.0|-0.797|-0.152|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.152|-0.797|
70942401|NCT00139659|141384712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.533|STANDARD_ERROR_OF_MEAN|0.202||||90.0|-0.866|-0.2|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.200|-0.866|
70942402|NCT00139659|141384712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.509|STANDARD_ERROR_OF_MEAN|0.204||||90.0|-0.845|-0.174|||Mixed Models Analysis|||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.174|-0.845|
70942403|NCT00139659|141384712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.412|STANDARD_ERROR_OF_MEAN|0.204||||90.0|-0.749|-0.076|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.076|-0.749|
70942404|NCT00139659|141384712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.707|STANDARD_ERROR_OF_MEAN|0.212||||90.0|-1.056|-0.358|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.358|-1.056|
71079647|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.42|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-7.03|-5.81|||Mixed Models Analysis|||Day 14, Hour 4||-5.81|-7.03|
71079648|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.64|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|90.0|-7.41|-5.87|||Mixed Models Analysis|||Day 14, Hour 8||-5.87|-7.41|
71079649|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|90.0|-7.18|-5.63|||Mixed Models Analysis|||Day 14, Hour 12||-5.63|-7.18|
71079650|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.77|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|90.0|-6.47|-5.07|||Mixed Models Analysis|||Day 14, Hour 24||-5.07|-6.47|
71117807|NCT05425732|141740596|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|9.2|||<|0.001|TWO_SIDED|95.0|5.6|12.9||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 15C: V116-PCV20 Percentage Difference||12.9|5.6|<0.001
71117808|NCT05425732|141740596|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|51.1|||<|0.001|TWO_SIDED|95.0|47.1|54.9||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 16F: V116-PCV20 Percentage Difference||54.9|47.1|<0.001
71117809|NCT05425732|141740596|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|66.3|||<|0.001|TWO_SIDED|95.0|62.8|69.6||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 17F: V116-PCV20 Percentage Difference||69.6|62.8|<0.001
71117810|NCT05425732|141740596|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|57.7|||<|0.001|TWO_SIDED|95.0|54.2|61.1||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 20A: V116-PCV20 Percentage Difference||61.1|54.2|<0.001
71117811|NCT05425732|141740596|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|42.2|||<|0.001|TWO_SIDED|95.0|37.6|46.6||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 23A: V116-PCV20 Percentage Difference||46.6|37.6|<0.001
71117812|NCT05425732|141740596|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|35.9|||<|0.001|TWO_SIDED|95.0|32.1|39.6||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 23B: V116-PCV20 Percentage Difference||39.6|32.1|<0.001
70942405|NCT00139659|141384712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.219||||90.0|-1.04|-0.32|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.320|-1.040|
70942406|NCT00139659|141384712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.765|STANDARD_ERROR_OF_MEAN|0.212||||90.0|-1.116|-0.415|||Mixed Models Analysis|||Week 52 Last Observation Carried Forward (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.415|-1.116|
71079651|NCT02187029|141666655|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.66|STANDARD_ERROR_OF_MEAN|1.26|||TWO_SIDED|90.0|-4.96|-0.35|||Mixed Models Analysis|||Follow-up, Day 25-29||-0.35|-4.96|
70942407|NCT02391116|141384734|OTHER||Percentage Difference|2.2|||||TWO_SIDED|90.0|-28.7|32.9|||Exact confidence intervals (CI)||ORR difference in FAS (N=54): ORR in CD79b mutant subgroup minus ORR in CD79b wild-type subgroup|||32.9|-28.7|
70942408|NCT02391116|141384734|OTHER||Percentage Difference|0.0|||||TWO_SIDED|90.0|-33.5|33.5|||Exact confidence intervals (CI)||ORR difference in PPS (N=40): ORR in CD79b mutant subgroup minus ORR in CD79b wild-type subgroup|||33.5|-33.5|
70942409|NCT02391116|141384735|OTHER||Percentage Difference|16.4|||||TWO_SIDED|90.0|-7.2|39.1|||Exact confidence intervals (CI)||ORR difference in FAS (N=52): ORR in ABC subgroup minus ORR in non-ABC group (i.e. combined GCB subgroup and Unclassifiable subgroup)|||39.1|-7.2|
70942410|NCT02391116|141384735|OTHER||Percentage Difference|20.8|||||TWO_SIDED|90.0|-6.8|46.2|||Exact confidence intervals (CI)||ORR difference in PPS (N=40): ORR in ABC subgroup minus ORR in non-ABC group (i.e. combined GCB subgroup and Unclassifiable subgroup)|||46.2|-6.8|
70942411|NCT02391116|141384735|OTHER||Percentage Difference|-18.5|||||TWO_SIDED|90.0|-40.1|4.6|||Exact confidence intervals (CI)||ORR difference in FAS (N=52): ORR in GCB subgroup minus ORR in non-GCB subgroup (i.e. combined ABC subgroup and Unclassifiable subgroup)|||4.6|-40.1|
70942412|NCT02391116|141384735|OTHER||Percentage Difference|-25.3|||||TWO_SIDED|90.0|-49.1|1.1|||Exact confidence intervals (CI)||ORR difference in PPS (N=40): ORR in GCB subgroup minus ORR in non-GCB subgroup (i.e. combined ABC subgroup and Unclassifiable subgroup)|||1.1|-49.1|
70942413|NCT02391116|141384735|OTHER||Percentage Difference|12.9|||||TWO_SIDED|90.0|-42.4|63.2|||Exact confidence intervals (CI)||ORR difference in FAS (N=52): ORR in Unclassifiable subgroup minus ORR in ABC / GCB subgroup (i.e. combined ABC subgroup and GCB subgroup)|||63.2|-42.4|
70942414|NCT02391116|141384735|OTHER||Percentage Difference|26.3|||||TWO_SIDED|90.0|-44.3|77.6|||Exact confidence intervals (CI)||ORR difference in PPS (N=40): ORR in Unclassifiable subgroup minus ORR in ABC / GCB subgroup (i.e. combined ABC subgroup and GCB subgroup)|||77.6|-44.3|
70942415|NCT01747629|141384763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92|STANDARD_ERROR_OF_MEAN|0.163|<|0.0001|TWO_SIDED|95.0|0.59|1.24||Significance at the 0.05 level.|mixed-model repeated-measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.24|0.59|<0.0001
70942416|NCT01747629|141384764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.05|STANDARD_ERROR_OF_MEAN|0.249|<|0.0001|TWO_SIDED|95.0|0.56|1.55||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially \[day 1, then day 8, then day 85\] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.55|0.56|<0.0001
71079652|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0355|STANDARD_ERROR_OF_MEAN|0.0423|||TWO_SIDED|90.0|-0.1103|0.0394|||Mixed Models Analysis|||Day 1, Hour 1||0.0394|-0.1103|
70854242|NCT03602560|141196749|OTHER|"Change from baseline is estimated by an analysis of covariance (ANCOVA) model with treatment group (including 3 levels:~Placebo, Initial Dose 5mg, and Initial Dose 10 mg) and randomization ALP stratification as factors, and baseline as a covariate.~The p-value for the interaction between treatment and stratum is 0.7595, hence the interaction is dropped from the model."|Risk Difference (RD)|-0.46||||0.4781|TWO_SIDED|95.0|-1.77|0.84|||ANCOVA|||||0.84|-1.77|0.4781
70854243|NCT01588470|141196767|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
70854244|NCT01588470|141196769|SUPERIORITY||Mean Difference (Final Values)|-1.1|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
70854245|NCT01012219|141196795|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.23|||||TWO_SIDED|90.0|0.96|1.56||||||||1.56|0.96|
70942417|NCT01747629|141384765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|0.212||0.0004|TWO_SIDED|95.0|0.35|1.19||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially \[day 1, then day 8, then day 85\] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.19|0.35|0.0004
70942418|NCT01747629|141384766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|0.57|1.28||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially \[day 1, then day 8, then day 85\] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.28|0.57|<0.0001
70942419|NCT04414397|141384781|SUPERIORITY||Rate Difference|66.9|||<|0.0001|TWO_SIDED|95.0|54.9|78.8||Analysis was performed using the SAS procedure MIANALYZE with normal approximation to generate an associated p-value for the comparison of responder rates between groups.|Multiple imputation regression|||JUVÉDERM® VOLUMA® XC Treatment vs No-treatment control||78.8|54.9|<0.0001
70942420|NCT04414397|141384785|OTHER||||||<|0.0001||||||P-value is based on a 2-sided paired t-test at the 5% level to demonstrate that the mean satisfaction score at Month 3 visit is statistically greater than at Baseline for the treatment group.|t-test, 2 sided|||||||<0.0001
70942421|NCT04414397|141384786|OTHER||||||<|0.0001||||||P-value is based on a 2-sided paired t-test at the 5% level to demonstrate that the mean satisfaction score at Month 3 is statistically greater than at Baseline for the treatment group.|t-test, 2 sided|||||||<0.0001
70942422|NCT01967719|141384895|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|56.57|||||TWO_SIDED|95.0|44.21|72.39|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (mTHS 2.2 - Group 1:mCC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of mTHS 2.2:mCC) for Cmax, therefore, there was no statistical hypothesis to be tested for this objective.||72.39|44.21|
71079653|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0152|STANDARD_ERROR_OF_MEAN|0.0631|||TWO_SIDED|90.0|-0.1269|0.0966|||Mixed Models Analysis|||Day 1, Hour 2||0.0966|-0.1269|
70942423|NCT01967719|141384896|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|55.64|||||TWO_SIDED|95.0|43.3|71.5|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (mTHS 2.2 - Group 1:mCC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of mTHS 2.2:mCC) for AUC(0-last), therefore, there was no statistical hypothesis to be tested for this objective.||71.50|43.30|
70942424|NCT02329223|141384897|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.7|STANDARD_ERROR_OF_MEAN|0.815|<|0.001|TWO_SIDED|95.0|-5.31|-2.098|||Mixed Model with repeated measures(MMRM)|||||-2.098|-5.310|<0.001
70942425|NCT02329223|141384897|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.29|STANDARD_ERROR_OF_MEAN|0.828||0.006|TWO_SIDED|95.0|-3.921|-0.654|||Mixed Model with repeated measures(MMRM)|||||-0.654|-3.921|0.006
70942426|NCT02924350|141384906|OTHER||Least square (LS) mean difference|-0.924|||<|0.0001|TWO_SIDED|95.0|-1.0547|-0.7927|||ANCOVA|ANCOVA: change from baseline in Schiff sensitivity score as response and treatment as a factor and baseline Schiff sensitivity score as a covariate|Difference is first named dentifrice minus second named dentifrice such that a negative difference favors first named dentifrice.|||-0.7927|-1.0547|<.0001
70942427|NCT00097708|141384909|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.654|TWO_SIDED|95.0|-2.2|1.4|||ANCOVA|||||1.4|-2.2|0.6540
70942428|NCT00097708|141384909|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2||||0.0005|TWO_SIDED|95.0|-5.0|-1.4|||ANCOVA|||||-1.4|-5.0|0.0005
71079654|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0331|STANDARD_ERROR_OF_MEAN|0.0422|||TWO_SIDED|90.0|-0.1078|0.0417|||Mixed Models Analysis|||Day 1, Hour 4||0.0417|-0.1078|
71079655|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0035|STANDARD_ERROR_OF_MEAN|0.0443|||TWO_SIDED|90.0|-0.075|0.082|||Mixed Models Analysis|||Day 1, Hour 8||0.0820|-0.0750|
71079656|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0502|STANDARD_ERROR_OF_MEAN|0.0367|||TWO_SIDED|90.0|-0.1153|0.0149|||Mixed Models Analysis|||Day 1, Hour 12||0.0149|-0.1153|
71079657|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.008|STANDARD_ERROR_OF_MEAN|0.0553|||TWO_SIDED|90.0|-0.1058|0.0899|||Mixed Models Analysis|||Day 1, Hour 24||0.0899|-0.1058|
71079658|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0539|STANDARD_ERROR_OF_MEAN|0.0561|||TWO_SIDED|90.0|-0.1538|0.046|||Mixed Models Analysis|||Day 7, pre-dose||0.0460|-0.1538|
71079659|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0109|STANDARD_ERROR_OF_MEAN|0.0506|||TWO_SIDED|90.0|-0.0793|0.101|||Mixed Models Analysis|||Day 7, Hour 1||0.1010|-0.0793|
71079660|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|0.033|STANDARD_ERROR_OF_MEAN|0.0496|||TWO_SIDED|90.0|-0.0554|0.1213|||Mixed Models Analysis|||Day 7, Hour 2||0.1213|-0.0554|
71079661|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0086|STANDARD_ERROR_OF_MEAN|0.0459|||TWO_SIDED|90.0|-0.0733|0.0905|||Mixed Models Analysis|||Day 7, Hour 4||0.0905|-0.0733|
71079662|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0244|STANDARD_ERROR_OF_MEAN|0.0349|||TWO_SIDED|90.0|-0.0865|0.0378|||Mixed Models Analysis|||Day 7, Hour 8||0.0378|-0.0865|
71079663|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0526|STANDARD_ERROR_OF_MEAN|0.0251|||TWO_SIDED|90.0|-0.0973|-0.0079|||Mixed Models Analysis|||Day 7, Hour 12||-0.0079|-0.0973|
70942429|NCT00097708|141384909|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.8||||0.0015|TWO_SIDED|95.0|1.1|4.5|||ANCOVA|||||4.5|1.1|0.0015
70942430|NCT00871143|141384939|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||An alpha level of .05 (two-sided) was set.|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on the outcome variable scores.||||<.001
70942431|NCT00871143|141384939|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Investigating the difference in BDD YBOCS score between baseline and week 12||||<.001
70942432|NCT00871143|141384939|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of Type 1 error.|t-test, 2 sided|||Investigating the difference in BDD YBOCS score between between baseline and 1 month follow up||||< .001
70942433|NCT00871143|141384939|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Investigating the difference in BDD YBOCS score between baseline and week 12||||<.01
70942434|NCT00871143|141384939|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Bonferroni correction was used to decrease risk of type I error|t-test, 2 sided|||Investigating the difference in BDD YBOCS score between baseline and 1 month follow up||||< 0.05
70942435|NCT00871143|141384940|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||An alpha level of .05 was set (two-sided).|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on the outcome variable scores.||||<.05
70942436|NCT00871143|141384940|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||T-tests were used to investigate significant differences between baseline and 12 week measures||||<0.01
71079664|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0298|STANDARD_ERROR_OF_MEAN|0.0331|||TWO_SIDED|90.0|-0.0889|0.0292|||Mixed Models Analysis|||Day 7, Hour 24||0.0292|-0.0889|
71079665|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0167|STANDARD_ERROR_OF_MEAN|0.0268|||TWO_SIDED|90.0|-0.0649|0.0315|||Mixed Models Analysis|||Day 14, pre-dose||0.0315|-0.0649|
71079666|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0616|STANDARD_ERROR_OF_MEAN|0.0337|||TWO_SIDED|90.0|0.001|0.1222|||Mixed Models Analysis|||Day 14, Hour 1||0.1222|0.0010|
71079667|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1025|STANDARD_ERROR_OF_MEAN|0.0512|||TWO_SIDED|90.0|0.0104|0.1945|||Mixed Models Analysis|||Day 14, Hour 2||0.1945|0.0104|
71079668|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0062|STANDARD_ERROR_OF_MEAN|0.0495|||TWO_SIDED|90.0|-0.0827|0.0952|||Mixed Models Analysis|||Day 14, Hour 4||0.0952|-0.0827|
71079669|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0124|STANDARD_ERROR_OF_MEAN|0.0443|||TWO_SIDED|90.0|-0.0672|0.0919|||Mixed Models Analysis|||Day 14, Hour 8||0.0919|-0.0672|
71079670|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0186|STANDARD_ERROR_OF_MEAN|0.0408|||TWO_SIDED|90.0|-0.0918|0.0547|||Mixed Models Analysis|||Day 14, Hour 12||0.0547|-0.0918|
71079671|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0413|STANDARD_ERROR_OF_MEAN|0.0433|||TWO_SIDED|90.0|-0.1192|0.0365|||Mixed Models Analysis|||Day 14, Hour 24||0.0365|-0.1192|
71079672|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4011|STANDARD_ERROR_OF_MEAN|0.3916|||TWO_SIDED|90.0|-0.2968|1.099|||Mixed Models Analysis|||Follow-up, Day 25-29||1.0990|-0.2968|
70942437|NCT00871143|141384940|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Bonferroni corrections were implemented to adjust for type I error|t-test, 2 sided|||T-tests were used to investigate significant differences between baseline and 1 month follow up.||||< 0.001
70942438|NCT00871143|141384940|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||T-tests were used to investigate significant differences between baseline and 12 week assessment measures and baseline and 1 month follow up measures.||||>0.05
70942439|NCT00871143|141384940|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of type I error|t-test, 2 sided|||T-tests were used to investigate significant differences between baseline and 1 month follow up measures.||||>0.05
71079673|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1175|STANDARD_ERROR_OF_MEAN|0.0537|||TWO_SIDED|90.0|0.0223|0.2127|||Mixed Models Analysis|||Day 1, Hour 1||0.2127|0.0223|
70942440|NCT00871143|141384941|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||An alpha level of .05 was set (two-sided).|Mixed Models Analysis|||A Linear mixed model was conducted to determine the predictive value of treatment group and/or time on the outcome variable MADRS scores.||||>0.05
70942441|NCT00871143|141384941|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Investigating the difference in MADRS score between baseline and week 12.||||<0.01
70942442|NCT00871143|141384941|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferonni corrections used to reduce risk of type I error|t-test, 2 sided|||Investigating the difference in MADRS score between baseline and 1 month follow up.||||>0.05
70942443|NCT00871143|141384941|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Investigating the difference in MADRS score between baseline and week 12.||||>0.05
71079674|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3845|STANDARD_ERROR_OF_MEAN|0.0802|||TWO_SIDED|90.0|0.2424|0.5266|||Mixed Models Analysis|||Day 1, Hour 2||0.5266|0.2424|
70942444|NCT00871143|141384941|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections used to decrease risk of type I error|t-test, 2 sided|||Investigating the difference in MADRS score between baseline and 1 month follow up.||||> 0.05
70942445|NCT00871143|141384942|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||An alpha level of .05 (two-sided) was set.|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on the outcome variable of AAI scores.||||<0.05
70942446|NCT00871143|141384942|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Bonferroni corrections were applied to decrease the risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences in AAI scores occurred from baseline to 12 week .||||<0.001
71079675|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3812|STANDARD_ERROR_OF_MEAN|0.0536|||TWO_SIDED|90.0|0.2862|0.4762|||Mixed Models Analysis|||Day 1, Hour 4||0.4762|0.2862|
70942447|NCT00871143|141384942|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of type 1 error|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences in AAI scores occurred from baseline to 2 month follow up.||||< 0.001
71079676|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2841|STANDARD_ERROR_OF_MEAN|0.0563|||TWO_SIDED|90.0|0.1843|0.3838|||Mixed Models Analysis|||Day 1, Hour 8||0.3838|0.1843|
71079677|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1462|STANDARD_ERROR_OF_MEAN|0.0467|||TWO_SIDED|90.0|0.0635|0.2289|||Mixed Models Analysis|||Day 1, Hour 12||0.2289|0.0635|
70942448|NCT00871143|141384942|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Bonferroni Correction was used in an attempt to reduce risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences in AAI scores occurred from baseline to 12 week .||||<0.05
70942449|NCT00871143|141384942|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were used to adjust for type 1 error|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences in AAI scores occurred from baseline to 2 month follow up.||||>0.05
70942450|NCT00871143|141384943|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||An alpha level of .05 was set (two-sided).|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on the PHQ-9 score.||||>0.05
70942451|NCT00871143|141384943|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Where more than 1 t test had been conducted on each variable, a Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to end of treatment (12 weeks).||||<0.05
70942452|NCT00871143|141384943|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of type I error|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 2 month follow up.||||> 0.05
70942453|NCT00871143|141384943|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||A Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to end of treatment (12 weeks).||||>0.05
70942454|NCT00871143|141384943|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 2 month follow up.||||> 0.05
70942455|NCT00871143|141384944|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||An alpha level of .05 was set (two-sided).|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on GAD-7 scores.||||<0.05
70942456|NCT00871143|141384944|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||A Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 12 week assessment.||||<0.01
70942457|NCT00871143|141384944|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were implemented to reduce the risk of type I error|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 2 month follow up assessment.||||> 0.05
70942458|NCT00871143|141384944|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||A Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 12 week assessment.||||>0.05
70942459|NCT00871143|141384944|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of type I error|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 2 month follow up assessment.||||> 0.05
70942460|NCT00871143|141384945|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||An alpha level of .05 was set (two-sided).|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on BIQLI scores.||||<0.05
70942461|NCT00871143|141384945|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||A Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated-measures t tests were then used to determine where significant differences in BIQLI occurred between baseline and end of treatment (12 weeks).||||<0.05
70942462|NCT00871143|141384945|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of type 1 error|t-test, 2 sided|||Repeated-measures t tests were then used to determine where significant differences in BIQLI occurred between baseline and 1 month follow up.||||< 0.05
70942463|NCT00871143|141384945|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||A Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated-measures t tests were then used to determine where significant differences in BIQLI occurred between baseline and end of treatment (12 weeks).||||>0.05
70942464|NCT00871143|141384945|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were used|t-test, 2 sided|||Repeated-measures t tests were then used to determine where significant differences in BIQLI occurred between baseline and 1 month follow up.||||> 0.05
70942465|NCT00352053|141384946|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline genotypic sensitivity score (GSS) (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Time-weighted average changes from baseline through Week 24 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Time-weighted average changes from baseline through Week 24 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are different (two-sided).||||0.55
70942466|NCT00352053|141384947|SUPERIORITY_OR_OTHER|||||||0.4||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Time-weighted average changes from baseline through Week 48 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Time-weighted average changes from baseline through Week 48 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are different (two-sided).||||0.40
70942467|NCT00352053|141384948|SUPERIORITY_OR_OTHER|||||||0.58||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 24 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 24 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are different (two-sided).||||0.58
70942468|NCT00352053|141384949|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 48 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are different (two-sided).||||0.37
70942469|NCT00352053|141384956|SUPERIORITY_OR_OTHER|||||||0.71||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 24 in plasma CD4 count for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 24 in CD4 count for the tenofovir DF and placebo groups are different (two-sided).||||0.71
70942470|NCT00352053|141384957|SUPERIORITY_OR_OTHER|||||||0.47||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 48 in plasma CD4 count for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in CD4 count for the tenofovir DF and placebo groups are different (two-sided).||||0.47
70954213|NCT00688870|141411074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.4|||Chan and Zhang|||Common serotypes - serotype 23F||4.4|-4.6|
71079678|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|0.168|STANDARD_ERROR_OF_MEAN|0.0702|||TWO_SIDED|90.0|0.0436|0.2924|||Mixed Models Analysis|||Day 1, Hour 24||0.2924|0.0436|
71079679|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1303|STANDARD_ERROR_OF_MEAN|0.083|||TWO_SIDED|90.0|-0.0172|0.2778|||Mixed Models Analysis|||Day 7, pre-dose||0.2778|-0.0172|
71079680|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1953|STANDARD_ERROR_OF_MEAN|0.0747||||90.0|0.0625|0.3281|||Mixed Models Analysis|||Day 7, Hour 1||0.3281|0.0625|
71079681|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5409|STANDARD_ERROR_OF_MEAN|0.0729|||TWO_SIDED|90.0|0.411|0.6707|||Mixed Models Analysis|||Day 7, Hour 2||0.6707|0.4110|
71079682|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5235|STANDARD_ERROR_OF_MEAN|0.0675|||TWO_SIDED|90.0|0.4032|0.6438|||Mixed Models Analysis|||Day 7, Hour 4||0.6438|0.4032|
71079683|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3857|STANDARD_ERROR_OF_MEAN|0.0512|||TWO_SIDED|90.0|0.2944|0.4769|||Mixed Models Analysis|||Day 7, Hour 8||0.4769|0.2944|
71079684|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0216|STANDARD_ERROR_OF_MEAN|0.0368|||TWO_SIDED|90.0|-0.0439|0.0872|||Mixed Models Analysis|||Day 7, Hour 12||0.0872|-0.0439|
71079685|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1708|STANDARD_ERROR_OF_MEAN|0.0486|||TWO_SIDED|90.0|0.0841|0.2574|||Mixed Models Analysis|||Day 7, Hour 24||0.2574|0.0841|
71079686|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|0.166|STANDARD_ERROR_OF_MEAN|0.0377|||TWO_SIDED|90.0|0.0982|0.2338|||Mixed Models Analysis|||Day 14, pre-dose||0.2338|0.0982|
71079687|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3524|STANDARD_ERROR_OF_MEAN|0.0477|||TWO_SIDED|90.0|0.2667|0.438|||Mixed Models Analysis|||Day 14, Hour 1||0.4380|0.2667|
71079688|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5631|STANDARD_ERROR_OF_MEAN|0.0724|||TWO_SIDED|90.0|0.433|0.6932|||Mixed Models Analysis|||Day 14, Hour 2||0.6932|0.4330|
71079689|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5807|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|0.4549|0.7065|||Mixed Models Analysis|||Day 14, Hour 4||0.7065|0.4549|
71079690|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2814|STANDARD_ERROR_OF_MEAN|0.0627|||TWO_SIDED|90.0|0.1688|0.394|||Mixed Models Analysis|||Day 14, Hour 8||0.3940|0.1688|
71079691|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1982|STANDARD_ERROR_OF_MEAN|0.0577|||TWO_SIDED|90.0|0.0945|0.3019|||Mixed Models Analysis|||Day 14, Hour 12||0.3019|0.0945|
71079692|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1465|STANDARD_ERROR_OF_MEAN|0.0615|||TWO_SIDED|90.0|0.0361|0.2569|||Mixed Models Analysis|||Day 14, Hour 24||0.2569|0.0361|
71079693|NCT02187029|141666661|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8565|STANDARD_ERROR_OF_MEAN|0.4796|||TWO_SIDED|90.0|0.0017|1.7112|||Mixed Models Analysis|||Follow-up, Day 25-29||1.7112|0.0017|
71079694|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.348|STANDARD_ERROR_OF_MEAN|0.209|||TWO_SIDED|90.0|-0.707|0.01|||Mixed Models Analysis|||Day 1, Hour 1||0.010|-0.707|
71079695|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.179|STANDARD_ERROR_OF_MEAN|0.205|||TWO_SIDED|90.0|-0.533|0.175|||Mixed Models Analysis|||Day 1, Hour 2||0.175|-0.533|
71117813|NCT05425732|141740596|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|74.2|||<|0.001|TWO_SIDED|95.0|71.1|77.1||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype24F: V116-PCV20 Percentage Difference||77.1|71.1|<0.001
71079696|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.258|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.568|0.052|||Mixed Models Analysis|||Day 1, Hour 4||0.052|-0.568|
71079697|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.046|STANDARD_ERROR_OF_MEAN|0.201||||90.0|-0.39|0.298|||Mixed Models Analysis|||Day 1, Hour 8||0.298|-0.390|
71079698|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.284|STANDARD_ERROR_OF_MEAN|0.168||||90.0|-0.575|0.006|||Mixed Models Analysis|||Day 1, Hour 12||0.006|-0.575|
71079699|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.166|STANDARD_ERROR_OF_MEAN|0.235|||TWO_SIDED|90.0|-0.569|0.237|||Mixed Models Analysis|||Day 1, Hour 24||0.237|-0.569|
71079700|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.263|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.657|0.132|||Mixed Models Analysis|||Day 7, pre-dose||0.132|-0.657|
71079701|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.221|||TWO_SIDED|90.0|-0.46|0.299|||Mixed Models Analysis|||Day 7, Hour 1||0.299|-0.460|
71079702|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.082|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.392|0.228|||Mixed Models Analysis|||Day 7, Hour 2||0.228|-0.392|
71117814|NCT05425732|141740596|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|58.6|||<|0.001|TWO_SIDED|95.0|54.8|62.1||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 31: V116-PCV20 Percentage Difference||62.1|54.8|<0.001
71079703|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.083|STANDARD_ERROR_OF_MEAN|0.189|||TWO_SIDED|90.0|-0.408|0.242|||Mixed Models Analysis|||Day 7, Hour 4||0.242|-0.408|
71079704|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.207|STANDARD_ERROR_OF_MEAN|0.174|||TWO_SIDED|90.0|-0.508|0.095|||Mixed Models Analysis|||Day 7, Hour 8||0.095|-0.508|
71079705|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.186|||TWO_SIDED|90.0|-0.451|0.191|||Mixed Models Analysis|||Day 7, Hour 12||0.191|-0.451|
71079706|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.125|STANDARD_ERROR_OF_MEAN|0.186|||TWO_SIDED|90.0|-0.445|0.196|||Mixed Models Analysis|||Day 7, Hour 24||0.196|-0.445|
71079707|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.188|STANDARD_ERROR_OF_MEAN|0.162|||TWO_SIDED|90.0|-0.472|0.097|||Mixed Models Analysis|||Day 14, pre-dose||0.097|-0.472|
71079708|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.152|STANDARD_ERROR_OF_MEAN|0.161|||TWO_SIDED|90.0|-0.434|0.13|||Mixed Models Analysis|||Day 14, Hour 1||0.130|-0.434|
71079709|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.231|STANDARD_ERROR_OF_MEAN|0.155|||TWO_SIDED|90.0|-0.504|0.043|||Mixed Models Analysis|||Day 14, Hour 2||0.043|-0.504|
71079710|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.405|STANDARD_ERROR_OF_MEAN|0.184|||TWO_SIDED|90.0|-0.722|-0.088|||Mixed Models Analysis|||Day 14, Hour 4||-0.088|-0.722|
71079711|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.249|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.56|0.062|||Mixed Models Analysis|||Day 14, Hour 8||0.062|-0.560|
70942471|NCT00352053|141384964|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 24 in plasma CD4% for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 24 in CD4% for the tenofovir DF and placebo groups are different (two-sided).||||0.26
70942472|NCT00352053|141384965|SUPERIORITY_OR_OTHER|||||||0.63||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 48 in plasma CD4% for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in CD4% for the tenofovir DF and placebo groups are different (two-sided).||||0.63
70942473|NCT00352053|141384972|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants who had at least a 1.0 log10 copies/mL decrease from baseline to Week 24 in HIV-1 RNA for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants who had at least a 1.0 log10 copies/mL decrease from baseline to Week 24 in HIV-1 RNA for the tenofovir DF and placebo groups is different (two-sided).||||0.67
70942474|NCT00352053|141384973|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants who had at least a 1.0 log10 copies/mL decrease from baseline to Week 48 in HIV-1 RNA for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants who had at least a 1.0 log10 copies/mL decrease from baseline to Week 48 in HIV-1 RNA for the tenofovir DF and placebo groups is different (two-sided).||||0.67
70942475|NCT00352053|141384980|SUPERIORITY_OR_OTHER|||||||1||95.0||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 24 for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 24 for the tenofovir DF and placebo groups is different (two-sided).||||1.00
70942476|NCT00352053|141384981|SUPERIORITY_OR_OTHER|||||||0.38||95.0||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 48 for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 48 for the tenofovir DF and placebo groups is different (two-sided).||||0.38
70942477|NCT00352053|141384988|SUPERIORITY_OR_OTHER|||||||0.22||95.0||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 for the tenofovir DF and placebo groups is different (two-sided).||||0.22
70942478|NCT00352053|141384989|SUPERIORITY_OR_OTHER|||||||0.48||95.0||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 for the tenofovir DF and placebo groups is different (two-sided).||||0.48
70942479|NCT00352053|141384996|SUPERIORITY_OR_OTHER|||||||0.29||95.0||||No adjustments for multiple comparisons were made.|Log Rank|No adjustments were made.||Null hypothesis: The survival functions for the tenofovir DF and placebo groups up to Week 48 are equal. Alternative hypothesis: The survival functions for the tenofovir DF and placebo groups up to Week 48 are different (two-sided).||||0.29
70942480|NCT01490359|141385001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.008|TWO_SIDED|95.0|1.03|1.71||The GEE model included baseline measure of consistent condom use, intervention condition, time (6- vs. 12-mo follow-up), and type of partner (steady vs casual partners) with robust standard errors and an independent working correlation matrix.|generalized estimating equations (GEE)||Estimate is odds ratio (intervention vs. health control).|Assuming alpha = 0.05, a 2-tailed test, ICC = 0.01, 15% attrition at 12-month follow-up, and N = 1,152 men in the trial from 44 neighborhoods with an average of 26 men in each neighborhood, the trial was estimated to have 81% power to detect a 10% increase in consistent condom use from 32% to 42% in the HIV/STI intervention group.||1.71|1.03|.008
70942481|NCT00405912|141385009|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Fisher Exact|1-sided test||Data were compared between treatment groups using Fisher's exact test for binary outcomes.||||0.51
70942482|NCT00405912|141385009|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Fisher Exact|1-sided test||Data were compared between treatment groups using Fisher's exact test for binary outcomes.||||0.25
70942483|NCT00405912|141385010|SUPERIORITY_OR_OTHER|||||||0.52||95.0|||||Fisher Exact|1 sided test||Data were compared between treatment groups using Fisher's exact test for binary outcomes.||||0.52
70942484|NCT00405912|141385010|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Fisher Exact|1-sided test||Data were compared between treatment groups using Fisher's exact test for binary outcomes.||||0.73
71079712|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.163|STANDARD_ERROR_OF_MEAN|0.176|||TWO_SIDED|90.0|-0.467|0.141|||Mixed Models Analysis|||Day 14, Hour 12||0.141|-0.467|
71117815|NCT05425732|141740596|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|53.2|||<|0.001|TWO_SIDED|95.0|49.6|56.6||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype35B: V116-PCV20 Percentage Difference||56.6|49.6|<0.001
71117816|NCT05425732|141740597|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.9|1.33||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 3: V116 18-49 years/V116 50-64 years GMT Ratio||1.33|0.90|<0.001
71117817|NCT05425732|141740597|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|2.06|||<|0.001|TWO_SIDED|95.0|1.61|2.62||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 6A: V116 18-49 years/V116 50-64 years GMT Ratio||2.62|1.61|<0.001
71117818|NCT05425732|141740597|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.51|||<|0.001|TWO_SIDED|5.0|1.23|1.84||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 7F: V116 18-49 years/V116 50-64 years GMT Ratio||1.84|1.23|<0.001
71117819|NCT05425732|141740597|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.5|||<|0.001|TWO_SIDED|95.0|1.26|1.79||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 8: V116 18-49 years/V116 50-64 years GMT Ratio||1.79|1.26|<0.001
71117820|NCT05425732|141740597|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.97|||<|0.001|TWO_SIDED|95.0|1.59|2.43||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 9N: V116 18-49 years/V116 50-64 years GMT Ratio||2.43|1.59|<0.001
71117821|NCT05425732|141740597|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.55|||<|0.001|TWO_SIDED|95.0|1.26|1.92||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 10A: V116 18-49 years/V116 50-64 years GMT Ratio||1.92|1.26|<0.001
71117822|NCT05425732|141740597|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.55|||<|0.001|TWO_SIDED|95.0|1.26|1.91||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 11A: V116 18-49 years/V116 50-64 years GMT Ratio||1.91|1.26|<0.001
71117823|NCT05425732|141740597|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.73|||<|0.001|TWO_SIDED|95.0|1.37|2.17||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 12F: V116 18-49 years/V116 50-64 years GMT Ratio||2.17|1.37|<0.001
71117824|NCT05425732|141740597|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.92|||<|0.001|TWO_SIDED|95.0|1.55|2.37||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 15A: V116 18-49 years/V116 50-64 years GMT Ratio||2.37|1.55|<0.001
71117825|NCT05425732|141740597|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.79|||<|0.001|TWO_SIDED|95.0|1.36|2.35||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 15C: V116 18-49 years/V116 50-64 years GMT Ratio||2.35|1.36|<0.001
71117826|NCT05425732|141740597|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.55|||<|0.001|TWO_SIDED|95.0|1.26|1.91||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 16F: V116 18-49 years/V116 50-64 years GMT Ratio||1.91|1.26|<0.001
71117827|NCT05425732|141740597|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.6|||<|0.001|TWO_SIDED|95.0|1.26|2.02||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 17F: V116 18-49 years/V116 50-64 years GMT Ratio||2.02|1.26|<0.001
71117828|NCT05425732|141740597|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.17|||<|0.001|TWO_SIDED|95.0|0.97|1.4||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 19A: V116 18-49 years/V116 50-64 years GMT Ratio||1.40|0.97|<0.001
71117829|NCT05425732|141740597|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.74|||<|0.001|TWO_SIDED|95.0|1.39|2.18||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 20A: V116 18-49 years/V116 50-64 years GMT Ratio||2.18|1.39|<0.001
71117830|NCT05425732|141740597|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.99|||<|0.001|TWO_SIDED|95.0|1.58|2.49||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 22F: V116 18-49 years/V116 50-64 years GMT Ratio||2.49|1.58|<0.001
70942485|NCT03730662|141385011|NON_INFERIORITY|"Although the primary objective is to establish noninferiority, sample size selection is guided by the objective of establishing superiority. The chosen sample size and randomization ratio also provides \>90% power to establish superiority of 10 mg LY3298176 and 15 mg LY3298176 doses to insulin glargine in absence of confounding effects of rescue therapy for persistent severe hyperglycemia (efficacy estimand)."|Mean Difference (Net)|-0.99|||<|0.001|TWO_SIDED|97.5|-1.13|-0.86|||Mixed Models Analysis|||||-0.86|-1.13|<0.001
70942486|NCT03730662|141385011|NON_INFERIORITY|"Although the primary objective is to establish noninferiority, sample size selection is guided by the objective of establishing superiority. The chosen sample size and randomization ratio also provides \>90% power to establish superiority of 10 mg LY3298176 and 15 mg LY3298176 doses to insulin glargine in absence of confounding effects of rescue therapy for persistent severe hyperglycemia (efficacy estimand)."|Mean Difference (Net)|-1.14|||<|0.001|TWO_SIDED|97.5|-1.28|-1.0|||Mixed Models Analysis|||||-1.00|-1.28|<0.001
70954214|NCT00688870|141411074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|95.0|||||TWO_SIDED|95.0|87.7|98.6|||Chan and Zhang|||Additional serotypes - serotype 1||98.6|87.7|
70942487|NCT03730662|141385012|NON_INFERIORITY|"Although the primary objective is to establish noninferiority, sample size selection is guided by the objective of establishing superiority. The chosen sample size and randomization ratio also provides \>90% power to establish superiority of 10 mg LY3298176 and 15 mg LY3298176 doses to insulin glargine in absence of confounding effects of rescue therapy for persistent severe hyperglycemia (efficacy estimand)."|Mean Difference (Net)|-0.8|||<|0.001|TWO_SIDED|97.5|-0.93|-0.66|||Mixed Models Analysis|||||-0.66|-0.93|<0.001
70942488|NCT03730662|141385013|SUPERIORITY||Mean Difference (Net)|-9.0|||<|0.001|TWO_SIDED|95.0|-9.8|-8.3|||Mixed Models Analysis|||||-8.3|-9.8|<0.001
70942489|NCT03730662|141385013|SUPERIORITY||Mean Difference (Net)|-11.4|||<|0.001|TWO_SIDED|95.0|-12.1|-10.6|||Mixed Models Analysis|||||-10.6|-12.1|<0.001
70942490|NCT03730662|141385013|SUPERIORITY||Mean Difference (Net)|-13.5|||<|0.001|TWO_SIDED|95.0|-14.3|-12.8|||Mixed Models Analysis|||||-12.8|-14.3|<0.001
70942491|NCT03730662|141385014|SUPERIORITY||Odds Ratio (OR)|4.78|||<|0.001|TWO_SIDED|95.0|3.47|6.58|||Regression, Logistic|||||6.58|3.47|<0.001
70942492|NCT03730662|141385014|SUPERIORITY||Odds Ratio (OR)|9.23|||<|0.001|TWO_SIDED|95.0|6.31|13.49|||Regression, Logistic|||||13.49|6.31|<0.001
70942493|NCT03730662|141385014|SUPERIORITY||Odds Ratio (OR)|11.87|||<|0.001|TWO_SIDED|95.0|7.88|17.89|||Regression, Logistic|||||17.89|7.88|<0.001
70942494|NCT03730662|141385015|SUPERIORITY||Mean Difference (Net)|1.0||||0.672|TWO_SIDED|95.0|-3.7|5.7|||Mixed Models Analysis|||||5.7|-3.7|0.672
70942495|NCT03730662|141385015|SUPERIORITY||Mean Difference (Net)|-3.6||||0.134|TWO_SIDED|95.0|-8.2|1.1|||Mixed Models Analysis|||||1.1|-8.2|0.134
70942496|NCT03730662|141385015|SUPERIORITY||Mean Difference (Net)|-8.0|||<|0.001|TWO_SIDED|95.0|-12.6|-3.4|||Mixed Models Analysis|||||-3.4|-12.6|<0.001
70942497|NCT01309243|141385021|NON_INFERIORITY_OR_EQUIVALENCE|"Null hypothesis: The FTC/RPV/TDF group was at least 12% worse than the EFV/FTC/TDF group with respect to the percentage of subjects achieving HIV-1 RNA \< 50 copies/mL (response rate, as defined by the snapshot analysis algorithm) at Week 48.~Alternative hypothesis: The FTC/RPV/TDF group was less than 12% worse than the EFV/FTC/TDF group with respect to the percentage of subjects achieving HIV-1 RNA \< 50 copies/mL at Week 48."|Difference in the response rates|4.1|||||TWO_SIDED|95.0|-1.1|9.2|||||The baseline stratum-weighted (HIV-1 RNA ≤ 100,000 and \> 100,000 copies/mL) difference in virologic success rates and its 95% CI were from baseline HIV-1 RNA adjusted Mantel-Haenszel proportions.|"The analysis was to assess the noninferiority of FTC/RPV/TDF versus EFV/FTC/TDF using a 95% confidence interval (CI) approach, with a noninferiority margin of 12% (lower bound of CI \> -12%).~700 subjects allocated 1:1 to either treatment arm was predicted to give \> 95% power when the proportion of responders in both treatment groups for the primary endpoint is 80% at Week 48."||9.2|-1.1|
70942498|NCT01309243|141385022|SUPERIORITY_OR_OTHER||Difference in the response rates|5.5|||||TWO_SIDED|95.0|-0.6|11.5|||||The baseline stratum-weighted (HIV-1 RNA ≤ 100,000 and \> 100,000 copies/mL) difference in virologic success rates and its 95% CI were from baseline HIV-1 RNA adjusted Mantel-Haenszel proportions.|||11.5|-0.6|
70854246|NCT00594425|141196854|SUPERIORITY_OR_OTHER||% success rate|5.53||||0.5288|TWO_SIDED|95.0|-7.97|19.04||Priori threshold for statistical significance was 5%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by center. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||19.04|-7.97|0.5288
70942499|NCT01309243|141385023|SUPERIORITY_OR_OTHER||Difference in LSM|11.0||||0.34|TWO_SIDED|95.0|-11.0|32.0||The p-value, and difference in least square means (LSM) and its 95% CI are from analysis of variance (ANOVA) with treatment and baseline HIV-1 RNA levels (≤ 100,000, \> 100,000 copies/mL) as fixed effect.|ANOVA|||||32|-11|0.34
70942500|NCT01309243|141385024|SUPERIORITY_OR_OTHER||Difference in LSM|20.0||||0.17|TWO_SIDED|95.0|-9.0|49.0||The p-value, and difference in LSM and its 95% CI are from ANOVA with treatment and baseline HIV-1 RNA levels (≤ 100,000, \> 100,000 copies/mL) as fixed effect.|ANOVA|||||49|-9|0.17
70942501|NCT01309243|141385025|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the difference in change from baseline at Week 48 is from ANOVA with treatment as fixed effect.|ANOVA|||||||< 0.001
70942502|NCT01309243|141385026|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the difference in change from baseline at Week 48 is from ANOVA with treatment as fixed effect.|ANOVA|||||||< 0.001
70942503|NCT01309243|141385027|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the difference in change from baseline at Week 48 is from ANOVA with treatment as fixed effect.|ANOVA|||||||< 0.001
70942504|NCT01309243|141385028|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the difference in change from baseline at Week 48 is from ANOVA with treatment as fixed effect.|ANOVA|||||||< 0.001
70942505|NCT03930238|141385031|SUPERIORITY||Group effect from Bayesian linear mixed|1646.0|||||TWO_SIDED|||||We did perform a Bayesian analysis which provided a posterior probability of 99.76% that the daily mean steps in the intervention group exceeded the daily mean steps in the comparison group.|Bayesian linear mixed effects regression||Posterior standard deviation = 578. We have 95% credible intervals - the interval that contains 95% of the posterior probability distribution of the parameter of interest - which ranges from 511 to 2781.|||||
70942506|NCT03930238|141385032|OTHER||Percentage|53.3|||||TWO_SIDED|||||||||||||
70942507|NCT00632931|141385034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||||90.0|-0.28|6.28||||||||6.28|-0.28|
70942508|NCT00632931|141385035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.45||||||90.0|-1.38|4.72||||||||4.72|-1.38|
70942509|NCT00632931|141385036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.07||||||90.0|-0.17|6.31||||||||6.31|-0.17|
70942510|NCT00632931|141385037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.84||||||90.0|-0.4|6.08||||||||6.08|-0.40|
70942511|NCT00632931|141385038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.44||||||90.0|3.21|9.68||||||||9.68|3.21|
70942512|NCT00632931|141385039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.33||||||90.0|1.05|7.6||||||||7.60|1.05|
71079713|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.317|STANDARD_ERROR_OF_MEAN|0.183|||TWO_SIDED|90.0|-0.633|-0.002|||Mixed Models Analysis|||Day 14, Hour 24||-0.002|-0.633|
71079714|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.094|STANDARD_ERROR_OF_MEAN|0.339|||TWO_SIDED|90.0|-0.683|0.496|||Mixed Models Analysis|||Follow-up, Day 25-29||0.496|-0.683|
71079715|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.266|||TWO_SIDED|90.0|-0.406|0.505|||Mixed Models Analysis|||Day 1, Hour 1||0.505|-0.406|
71079716|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|0.257|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.193|0.707|||Mixed Models Analysis|||Day 1, Hour 2||0.707|-0.193|
71079717|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|0.091|STANDARD_ERROR_OF_MEAN|0.229|||TWO_SIDED|90.0|-0.302|0.485|||Mixed Models Analysis|||Day 1, Hour 4||0.485|-0.302|
71079718|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.256|||TWO_SIDED|90.0|-0.107|0.768|||Mixed Models Analysis|||Day 1, Hour 8||0.768|-0.107|
70942513|NCT00632931|141385040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.66||||||90.0|-0.7|6.02||||||||6.02|-0.70|
70942514|NCT00632931|141385041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.51||||||90.0|3.19|9.82||||||||9.82|3.19|
70942515|NCT03009019|141385042|SUPERIORITY||Odds Ratio (OR)|1.4||||0.075|TWO_SIDED|95.0|0.97|2.03|||Fisher Exact|||Last Observation Carried Forward (LOCF)||2.03|0.97|0.075
70942516|NCT03009019|141385042|SUPERIORITY||Odds Ratio (OR)|1.47||||0.055|TWO_SIDED|95.0|1.0|2.14|||Fisher Exact|||Observed cases (OC)||2.14|1.00|0.055
70942517|NCT03009019|141385043|SUPERIORITY||Odds Ratio (OR)|1.75||||0.003|TWO_SIDED|95.0|1.22|2.52|||Regression, Logistic|||||2.52|1.22|0.003
70942518|NCT03009019|141385043|SUPERIORITY||Odds Ratio (OR)|1.76||||0.003|TWO_SIDED|95.0|1.22|2.55|||Regression, Logistic|||||2.55|1.22|0.003
70942519|NCT03341312|141385067|SUPERIORITY||ratio of LS Means|0.75|||||TWO_SIDED|95.0|0.42|1.16||||||||1.16|0.42|
70942520|NCT03341312|141385067|SUPERIORITY||ratio of LS Means|0.74|||||TWO_SIDED|95.0|0.49|1.01||||||||1.01|0.49|
71079719|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|0.283|STANDARD_ERROR_OF_MEAN|0.214|||TWO_SIDED|90.0|-0.087|0.653|||Mixed Models Analysis|||Day 1, Hour 12||0.653|-0.087|
71079720|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|0.488|STANDARD_ERROR_OF_MEAN|0.299|||TWO_SIDED|90.0|-0.024|1.0|||Mixed Models Analysis|||Day 1, Hour 24||1.000|-0.024|
71079721|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|0.206|STANDARD_ERROR_OF_MEAN|0.327|||TWO_SIDED|90.0|-0.356|0.768|||Mixed Models Analysis|||Day 7, pre-dose||0.768|-0.356|
70942521|NCT01812707|141385070|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤0.05|ANCOVA|||"Each treatment group was compared to placebo using ANCOVA-derived contrasts.~A hierarchical testing procedure was applied to ensure strong control of overall Type-I error rate at 0.05 level. Order was following:~1. Alirocumab 150 mg Q2W versus placebo~2. Alirocumab 75 mg Q2W versus placebo~3. Alirocumab 50 mg Q2W versus placebo~Testing continued only when high-order test was statistically significant at 5% level."||||<0.0001
70942522|NCT01812707|141385070|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤0.05|ANCOVA|||||||<0.0001
71079722|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|0.123|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|90.0|-0.41|0.656|||Mixed Models Analysis|||Day 7, Hour 1||0.656|-0.410|
71079723|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|0.396|STANDARD_ERROR_OF_MEAN|0.246|||TWO_SIDED|90.0|-0.025|0.818|||Mixed Models Analysis|||Day 7, Hour 2||0.818|-0.025|
71079724|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.077|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.523|0.368|||Mixed Models Analysis|||Day 7, Hour 4||0.368|-0.523|
71079725|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|0.254|STANDARD_ERROR_OF_MEAN|0.237|||TWO_SIDED|90.0|-0.154|0.661|||Mixed Models Analysis|||Day 7, Hour 8||0.661|-0.154|
71079726|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.125|STANDARD_ERROR_OF_MEAN|0.256|||TWO_SIDED|90.0|-0.564|0.315|||Mixed Models Analysis|||Day 7, Hour 12||0.315|-0.564|
70942523|NCT01812707|141385070|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤0.05|ANCOVA|||||||<0.0001
71079727|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|0.458|STANDARD_ERROR_OF_MEAN|0.256|||TWO_SIDED|90.0|0.019|0.897|||Mixed Models Analysis|||Day 7, Hour 24||0.897|0.019|
71079728|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|0.418|STANDARD_ERROR_OF_MEAN|0.215|||TWO_SIDED|90.0|0.043|0.792|||Mixed Models Analysis|||Day 14, pre-dose||0.792|0.043|
71079729|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|0.521|STANDARD_ERROR_OF_MEAN|0.213|||TWO_SIDED|90.0|0.15|0.893|||Mixed Models Analysis|||Day 14, Hour 1||0.893|0.150|
71079730|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.204|||TWO_SIDED|90.0|0.172|0.888|||Mixed Models Analysis|||Day 14, Hour 2||0.888|0.172|
70942524|NCT01697592|141385097|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.93|||<|0.001|TWO_SIDED|95.0|-1.1|-0.75|||Constrained longitudinal data analysis|Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.||||-0.75|-1.10|<0.001
71079731|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|0.357|STANDARD_ERROR_OF_MEAN|0.247|||TWO_SIDED|90.0|-0.069|0.782|||Mixed Models Analysis|||Day 14, Hour 4||0.782|-0.069|
71079732|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|0.088|STANDARD_ERROR_OF_MEAN|0.242|||TWO_SIDED|90.0|-0.328|0.503|||Mixed Models Analysis|||Day 14, Hour 8||0.503|-0.328|
71079733|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|0.406|STANDARD_ERROR_OF_MEAN|0.236|||TWO_SIDED|90.0|0.0|0.812|||Mixed Models Analysis|||Day 14, Hour 12||0.812|0.000|
71079734|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|0.377|STANDARD_ERROR_OF_MEAN|0.247|||TWO_SIDED|90.0|-0.047|0.802|||Mixed Models Analysis|||Day 14, Hour 24||0.802|-0.047|
71079735|NCT02187029|141666662|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.223|STANDARD_ERROR_OF_MEAN|0.418|||TWO_SIDED|90.0|-0.949|0.502|||Mixed Models Analysis|||Follow-up, Day 25-29||0.502|-0.949|
71079736|NCT02187029|141666663|SUPERIORITY_OR_OTHER||LS Mean Difference|316.89|STANDARD_ERROR_OF_MEAN|166.57|||TWO_SIDED|90.0|21.91|611.88|||Mixed Models Analysis|||Day 1||611.88|21.91|
71079737|NCT02187029|141666663|SUPERIORITY_OR_OTHER||LS Mean Difference|61.97|STANDARD_ERROR_OF_MEAN|88.27|||TWO_SIDED|90.0|-94.87|218.82|||Mixed Models Analysis|||Day 7||218.82|-94.87|
71079738|NCT02187029|141666663|SUPERIORITY_OR_OTHER||LS Mean Difference|107.96|STANDARD_ERROR_OF_MEAN|100.38|||TWO_SIDED|90.0|-71.2|287.11|||Mixed Models Analysis|||Day 14||287.11|-71.20|
71079739|NCT02187029|141666663|SUPERIORITY_OR_OTHER||LS Mean Difference|433.21|STANDARD_ERROR_OF_MEAN|211.71|||TWO_SIDED|90.0|58.3|808.13|||Mixed Models Analysis|||Day 1||808.13|58.30|
71079740|NCT02187029|141666663|SUPERIORITY_OR_OTHER||LS Mean Difference|13.2|STANDARD_ERROR_OF_MEAN|125.47|||TWO_SIDED|90.0|-208.07|234.47|||Mixed Models Analysis|||Day 7||234.47|-208.07|
71079741|NCT02187029|141666663|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.83|STANDARD_ERROR_OF_MEAN|142.95|||TWO_SIDED|90.0|-285.26|225.6|||Mixed Models Analysis|||Day 14||225.60|-285.26|
71079742|NCT02187029|141666664|SUPERIORITY_OR_OTHER||LS Mean Difference|3.44|STANDARD_ERROR_OF_MEAN|1.57|||TWO_SIDED|90.0|0.71|6.17|||Mixed Models Analysis|||Day 1||6.17|0.71|
71079743|NCT02187029|141666664|SUPERIORITY_OR_OTHER||LS Mean Difference|3.67|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|90.0|1.97|5.37|||Mixed Models Analysis|||Day 7||5.37|1.97|
71079744|NCT02187029|141666664|SUPERIORITY_OR_OTHER||LS Mean Difference|8.1|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|6.24|9.96|||Mixed Models Analysis|||Day 14||9.96|6.24|
71079745|NCT02187029|141666664|SUPERIORITY_OR_OTHER||LS Mean Difference|13.12|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|90.0|9.65|16.59|||Mixed Models Analysis|||Day 1||16.59|9.65|
71079746|NCT02187029|141666664|SUPERIORITY_OR_OTHER||LS Mean Difference|27.99|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|90.0|25.49|30.49|||Mixed Models Analysis|||Day 7||30.49|25.49|
71079747|NCT02187029|141666664|SUPERIORITY_OR_OTHER||LS Mean Difference|28.77|STANDARD_ERROR_OF_MEAN|1.48|||TWO_SIDED|90.0|26.14|31.41|||Mixed Models Analysis|||Day 14||31.41|26.14|
71079748|NCT02187029|141666665|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|90.0|-1.31|3.1|||Mixed Models Analysis|||Day 1||3.10|-1.31|
71079749|NCT02187029|141666665|SUPERIORITY_OR_OTHER||LS Mean Difference|2.91|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|90.0|0.71|5.11|||Mixed Models Analysis|||Day 7||5.11|0.71|
71079750|NCT02187029|141666665|SUPERIORITY_OR_OTHER||LS Mean Difference|3.59|STANDARD_ERROR_OF_MEAN|1.33|||TWO_SIDED|90.0|1.33|5.85|||Mixed Models Analysis|||Day 14||5.85|1.33|
71079751|NCT02187029|141666665|SUPERIORITY_OR_OTHER||LS Mean Difference|1.51|STANDARD_ERROR_OF_MEAN|1.64|||TWO_SIDED|90.0|-1.29|4.31|||Mixed Models Analysis|||Day 1||4.31|-1.29|
71079752|NCT02187029|141666665|SUPERIORITY_OR_OTHER||LS Mean Difference|7.73|STANDARD_ERROR_OF_MEAN|1.86|||TWO_SIDED|90.0|4.57|10.89|||Mixed Models Analysis|||Day 7||10.89|4.57|
71079753|NCT02187029|141666665|SUPERIORITY_OR_OTHER||LS Mean Difference|9.07|STANDARD_ERROR_OF_MEAN|1.86|||TWO_SIDED|90.0|5.91|12.23|||Mixed Models Analysis|||Day 14||12.23|5.91|
71079754|NCT02700425|141666689|OTHER||||||<|0.001||||||P-value was not adjusted for multiple comparisons. Test was two-tailed, considered statistically significant with a p-value \<0.05, and conducted using SAS version 9.4 (SAS Institute Inc, Cary, NC) and STATA MP version 15 (College Station, TX).|Sign test|Wilcoxon signed rank test||The sample size was estimated based on the primary endpoint of echocardiographic response to test the hypothesis that an absolute 10% greater improvement in LVEF would be observed with His Bundle Pacing compared to Coronary Sinus Pacing, with a significance level of 0.05 and a power of 0.80. Primary outcome was presented at baseline and 6-months as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with the Wilcoxon signed rank test.||||<0.001
71079755|NCT02700425|141666689|OTHER||||||<|0.001||||||P-value was not adjusted for multiple comparisons. Test was two-tailed, considered statistically significant with a p-value \<0.05, and conducted using SAS version 9.4 (SAS Institute Inc, Cary, NC) and STATA MP version 15 (College Station, TX).|Sign test|Wilcoxon signed rank test||The sample size was estimated based on the primary endpoint of echocardiographic response to test the hypothesis that an absolute 10% greater improvement in LVEF would be observed with His Bundle Pacing compared to Coronary Sinus Pacing, with a significance level of 0.05 and a power of 0.80. Primary outcome was presented at baseline and 6-months as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with the Wilcoxon signed rank test.||||<0.001
71079756|NCT02700425|141666690|OTHER|paired t-test||||||0.002||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||0.002
71079757|NCT02700425|141666690|OTHER|paired t-test||||||0.002|||||||t-test, 2 sided|||Primary outcome of His Bundle Pacing was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||0.002
71117831|NCT05425732|141740597|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.87|||<|0.001|TWO_SIDED|95.0|1.43|2.44||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 23A: V116 18-49 years/V116 50-64 years GMT Ratio||2.44|1.43|<0.001
70942525|NCT01697592|141385097|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.98|||<|0.001|TWO_SIDED|95.0|-1.37|-0.6|||Constrained longitudinal data analysis|Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.||||-0.60|-1.37|<0.001
70942526|NCT01697592|141385097|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.92|||<|0.001|TWO_SIDED|95.0|-1.29|-0.56|||Constrained longitudinal data analysis|Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.||||-0.56|-1.29|<0.001
70942527|NCT01697592|141385097|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.16|||<|0.001|TWO_SIDED|95.0|-1.45|-0.88|||Constrained longitudinal data analysis|Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.||||-0.88|-1.45|<0.001
71117832|NCT05425732|141740597|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.51|||<|0.001|TWO_SIDED|95.0|1.11|2.04||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 23B: V116 18-49 years/V116 50-64 years GMT Ratio||2.04|1.11|<0.001
71117833|NCT05425732|141740597|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.36|||<|0.001|TWO_SIDED|95.0|1.1|1.67||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 24F: V116 18-49 years/V116 50-64 years GMT Ratio||1.67|1.10|<0.001
71117834|NCT05425732|141740597|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|2.1|||<|0.001|TWO_SIDED|95.0|1.63|2.69||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 31: V116 18-49 years/V116 50-64 years GMT Ratio||2.69|1.63|<0.001
71117835|NCT05425732|141740597|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.98|||<|0.001|TWO_SIDED|95.0|1.52|2.57||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 33F: V116 18-49 years/V116 50-64 years GMT Ratio||2.57|1.52|<0.001
71117836|NCT05425732|141740597|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.54|||<|0.001|TWO_SIDED|95.0|1.26|1.87||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 35B: V116 18-49 years/V116 50-64 years GMT Ratio||1.87|1.26|<0.001
71117837|NCT05425732|141740598|OTHER|"A conclusion of acceptability is based on the lower bound of the 95% CI of the percentages of participants with a~≥4-fold rise from baseline to 30 days postvaccination being \> 50 percentage points (one-sided p-value \< 0.025)."||||||0.667||||||1-sided|Clopper-Pearson method.|||Serotype 6C||||0.667
71117838|NCT05425732|141740598|OTHER|"A conclusion of acceptability is based on the lower bound of the 95% CI of the percentages of participants with a~≥4-fold rise from baseline to 30 days postvaccination being \> 50 percentage points (one-sided p-value \< 0.025)."|||||<|0.001||||||1-sided|Clopper-Pearson method.|||Serotype 15B||||<0.001
71117839|NCT05425732|141740599|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|2.05|||||TWO_SIDED|95.0|1.52|2.77|||||V116 18-49 years/V116 50-64 years|Serotype 6C: V116 18-49 years/V116 50-64 years GMT Ratio||2.77|1.52|
71117840|NCT05425732|141740599|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT|2.02|||<|0.001|TWO_SIDED|95.0|1.57|2.6||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 15B: V116 18-49 years/V116 50-64 years GMT ratio||2.60|1.57|<0.001
70854247|NCT00594425|141196854|SUPERIORITY_OR_OTHER||% success rate|3.95||||0.7539|TWO_SIDED|95.0|-8.79|16.69||Priori threshold for statistical significance was 5%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by center. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||16.69|-8.79|0.7539
71117841|NCT05425732|141740600|OTHER|cLDA model|GMC Ratio|1.47|||||TWO_SIDED|95.0|1.35|1.6|||||V116/PCV20|Serotype 3: V116/PCV20 GMC Ratio||1.60|1.35|
71117842|NCT05425732|141740600|OTHER|cLDA model|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.7|0.89|||||V116/PCV20|Serotype 6A: V116/PCV20 GMC Ratio||0.89|0.70|
71117843|NCT05425732|141740600|OTHER|cLDA model|GMC Ratio|1.06|||||TWO_SIDED|95.0|0.95|1.18|||||V116/PCV20|Serotype 7F: V116/PCV20 GMC Ratio||1.18|0.95|
71117844|NCT05425732|141740600|OTHER|cLDA model|GMC Ratio|1.43|||||TWO_SIDED|95.0|1.29|1.59|||||V116/PCV20|Serotype 8: V116/PCV20 GMC Ratio||1.59|1.29|
71117845|NCT05425732|141740600|OTHER|cLDA model|GMC Ratio|0.82|||||TWO_SIDED|95.0|0.72|0.92|||||V116/PCV20|Serotype 10A: V116/PCV20 GMC Ratio||0.92|0.72|
71117846|NCT05425732|141740600|OTHER|cLDA model|GMC Ratio|1.23|||||TWO_SIDED|95.0|1.11|1.36|||||V116/PCV20|Serotype 11A: V116/PCV20 GMC Ratio||1.36|1.11|
71117847|NCT05425732|141740600|OTHER|cLDA model|GMC Ratio|1.1|||||TWO_SIDED|95.0|0.96|1.26|||||V116/PCV20|Serotype 12F: V116/PCV20 GMC Ratio||1.26|0.96|
71117848|NCT05425732|141740600|OTHER|cLDA model|GMC Ratio|0.7|||||TWO_SIDED|95.0|0.63|0.77|||||V116/PCV20|Serotype 19A: V116/PCV20 GMC Ratio||0.77|0.63|
71117849|NCT05425732|141740600|OTHER|cLDA model|GMC Ratio|0.8|||||TWO_SIDED|95.0|0.72|0.9|||||V116/PCV20|Serotype 22F: V116/PCV20 GMC Ratio||0.90|0.72|
71117850|NCT05425732|141740600|OTHER|cLDA model|GMC Ratio|1.06|||||TWO_SIDED|95.0|0.95|1.18|||||V116/PCV20|Serotype 33F: V116/PCV20 GMC Ratio||1.18|0.95|
71117851|NCT05425732|141740600|OTHER|cLDA model|GMC Ratio|5.41|||||TWO_SIDED|95.0|4.82|6.06|||||V116/PCV20|Serotype 9N: V116/PCV20 GMC Ratio||6.06|4.82|
70942528|NCT01697592|141385097|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.8|||<|0.001|TWO_SIDED|95.0|-1.06|-0.54|||Constrained longitudinal data analysis|Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.||||-0.54|-1.06|<0.001
70954215|NCT00688870|141411074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|82.5|||||TWO_SIDED|95.0|72.0|90.1|||Chan and Zhang|||Additional serotypes - serotype 3||90.1|72.0|
70942529|NCT00265096|141385125|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The positive test is concluded if there is a significant difference between combined golimumab and placebo groups and at least one of the pair-wise conparisons at 0.05 level.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage).||Null Hypothesis: No difference in ACR 20 response comparing Groups I vs II and Groups I vs III. Sample size (n=396; 110 placebo, 286 combined golimumab) provided \>98% power to detect a significant difference (alpha=0.05) in ACR 20 response between treatment groups, assuming equal proportions of subjects receiving methotrexate (MTX) at baseline and the difference in ACR 20 response of 27% in subjects without MTX and 17-27% in subjects with MTX, between placebo and combined golimumab groups.||||<0.001
70942530|NCT00265096|141385125|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage).||||||<0.001
70942531|NCT00265096|141385125|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage).||||||<0.001
70942532|NCT00265096|141385126|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)||||||<0.001
70942533|NCT00265096|141385126|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)||||||<0.001
70942534|NCT00265096|141385126|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)||||||<0.001
70942535|NCT00265096|141385127|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|With 2 factors (treatment group and subject's baseline Methotrexate (MTX) usage)||||||<0.001
70942536|NCT00265096|141385127|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|With 2 factors (treatment group and subject's baseline MTX usage)||||||<0.001
70942537|NCT00265096|141385127|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|With 2 factors (treatment group and subject's baseline MTX usage)||||||<0.001
70942538|NCT00265096|141385128|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|With 2 factors (treatment and subject's baseline Methotrexate (MTX) usage)||||||<0.001
70942539|NCT00265096|141385128|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|With 2 factors (with treatment and subject's baseline MTX usage)||||||<0.001
70942540|NCT00265096|141385128|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|With 2 factors (treatment and subject's baseline MTX usage)||||||<0.001
70942541|NCT00265096|141385129|SUPERIORITY_OR_OTHER|||||||0.015||||||The test was not to be performed if the test of ACR 20 at Week 24 was not significant.|ANOVA|Analysis of Variance (ANOVA) on van der Waerden scores with 2 factors: treatment group and participant's baseline methotrexate (MTX) usage||Null Hypothesis: There is no difference in change from baseline among 3 treatment groups. Sample size (n=396, 110 placebo, 286 combined golimumab) provided \>93% power to detect a significant difference (alpha=0.05) in change from baseline between treatment groups, assuming 50% of subjects received MTX at baseline, and mean change from baseline for combined golimumab of 0, and a mean increase for placebo of 0.1 in subjects who received MTX at baseline and 0.6 in subjects who did not receive MTX||||0.015
70942542|NCT00265096|141385129|SUPERIORITY_OR_OTHER|||||||0.011||||||The test was not to be performed if the test of ACR 20 at Week 24 was not significant|ANOVA|ANOVA on van der Waerden scores with 2 factors: treatment group and participant's baseline Methotrexate (MTX) usage||||||0.011
70942543|NCT00265096|141385129|SUPERIORITY_OR_OTHER|||||||0.086||||||The test was not to be performed if the test of ACR 20 at Week 24 was not significant|ANOVA|ANOVA on van der Waerden scores with 2 factors: treatment group and participant's baseline Methotrexate (MTX) usage||||||0.086
70942544|NCT00265096|141385130|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline Methotrexate (MTX) usage)||||||<0.001
70942545|NCT00265096|141385130|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)||||||<0.001
70942546|NCT00265096|141385130|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)||||||<0.001
70942547|NCT03897049|141385133|SUPERIORITY||Odds Ratio (OR)|0.961||||0.914|TWO_SIDED|95.0|0.463|1.994|||Regression, Logistic|||||1.994|0.463|0.914
70942548|NCT03897049|141385134|SUPERIORITY||Odds Ratio (OR)|0.979||||0.99|TWO_SIDED|95.0|0.473|2.074|||Regression, Logistic|||||2.074|0.473|0.990
70942549|NCT03897049|141385135|SUPERIORITY||Odds Ratio (OR)|1.434||||0.167|TWO_SIDED|95.0|0.861|2.39|||Regression, Logistic|||||2.390|0.861|0.167
70942550|NCT03897049|141385136|SUPERIORITY||Odds Ratio (OR)|1.492||||0.118|TWO_SIDED|95.0|0.903|2.466|||Regression, Logistic|||||2.466|0.903|0.118
70942551|NCT03897049|141385137|SUPERIORITY||Odds Ratio (OR)|1.335||||0.265|TWO_SIDED|95.0|0.803|2.221|||Regression, Logistic|||||2.221|0.803|0.265
70942552|NCT03897049|141385138|SUPERIORITY||Odds Ratio (OR)|0.99||||0.971|TWO_SIDED|95.0|0.593|1.654|||Regression, Logistic|||||1.654|0.593|0.971
70942553|NCT03897049|141385139|SUPERIORITY||Mean Difference (Net)|-0.27||||0.942|TWO_SIDED||||||Regression, Linear|||||||0.942
70942554|NCT03897049|141385140|SUPERIORITY||Mean Difference (Net)|0.02||||0.741|TWO_SIDED||||||Regression, Linear|||||||0.741
70942555|NCT03897049|141385141|SUPERIORITY||Mean Difference (Net)|0.07||||0.494|TWO_SIDED||||||Regression, Linear|||||||0.494
70942556|NCT03897049|141385142|SUPERIORITY||Mean Difference (Net)|0.15||||0.651|TWO_SIDED||||||Regression, Linear|||||||0.651
70942557|NCT03897049|141385143|SUPERIORITY||Mean Difference (Net)|0.3||||0.022|TWO_SIDED||||||Regression, Linear|||||||0.022
70942558|NCT03897049|141385144|SUPERIORITY||Mean Difference (Net)|2.85||||0.189|TWO_SIDED||||||Regression, Linear|||||||0.189
70942559|NCT03897049|141385145|SUPERIORITY||Mean Difference (Final Values)|3.07||||0.218|TWO_SIDED||||||Regression, Linear|||||||0.218
70942560|NCT03897049|141385146|SUPERIORITY||Odds Ratio (OR)|0.479||||0.149|TWO_SIDED|95.0|0.173|1.305|||Regression, Logistic|||||1.305|0.173|0.149
70942561|NCT03897049|141385147|SUPERIORITY||Odds Ratio (OR)|1.111||||0.839|TWO_SIDED|95.0|0.403|3.063|||Regression, Logistic|||||3.063|0.403|0.839
70942562|NCT03897049|141385148|SUPERIORITY||Odds Ratio (OR)|3.302||||0.063|TWO_SIDED|95.0|0.937|11.641|||Regression, Logistic|||||11.641|0.937|0.063
70942563|NCT03897049|141385149|SUPERIORITY||Mean Difference (Net)|-0.08||||0.65|TWO_SIDED||||||Regression, Linear|||||||0.650
71079758|NCT02700425|141666691|OTHER|Log rank test of a survival analysis||||||0.62||||||P-value did not need to be adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Log Rank|||Primary outcome of time to first cardiovascular hospitalization or death by His Bundle Pacing compared to Coronary Sinus Pacing presented median and interquartile range in years based upon the Shapiro-Wilks test of normality, and then analyzed with a log rank test.||||0.62
71079759|NCT02700425|141666692|OTHER|||||||0.09||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|Wilcoxon sign rank test||NYHA functional class of Coronary Sinus Pacing arm was presented at baseline as medians (interquartile ranges) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon sign rank test.||||0.09
71079760|NCT02700425|141666692|OTHER|||||||0.32||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|Wilcoxon sign rank test||NYHA functional class of the His Bundle Pacing arm was presented at baseline and 12 months as medians (interquartile ranges) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon sign rank test.||||0.32
71079761|NCT02700425|141666693|OTHER|||||||0.35||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Quality of Life was presented at baseline and 1-year as medians (interquartile range) for patients with His Bundle Pacing based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.35
71079762|NCT02700425|141666693|OTHER|||||||0.07||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Quality of Life was presented at baseline and 1-year as medians (interquartile range) for patients with Coronary Sinus Pacing based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.07
71079763|NCT02700425|141666694|OTHER|Log rank test of a survival analysis||||||0.14||||||P-value did not need to be adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Log Rank|||Primary outcome of time to first cardiovascular rehospitalization by His Bundle Pacing compared to Coronary Sinus Pacing presented median and interquartile range in years based upon the Shapiro-Wilks test of normality, and then analyzed with a log rank test.||||0.14
71079764|NCT02700425|141666695|OTHER|Log rank test of a survival analysis||||||0.14||||||P-value did not need to be adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Log Rank|||Primary outcome of time to first treated VT/VF by His Bundle Pacing compared to Coronary Sinus Pacing presented median and interquartile range in years based upon the Shapiro-Wilks test of normality, and then analyzed with a log rank test.||||0.14
71079765|NCT01301079|141666696|SUPERIORITY_OR_OTHER|||||||0.113|TWO_SIDED||||||Mann-Whitney|||||||0.113
71079766|NCT01301079|141666697|SUPERIORITY_OR_OTHER|||||||0.946|TWO_SIDED||||||t-test, 2 sided|||||||0.946
71079767|NCT01301079|141666698|SUPERIORITY_OR_OTHER|||||||0.999|TWO_SIDED||||||t-test, 2 sided|||||||0.999
71079768|NCT01301079|141666699|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||t-test, 2 sided|||||||0.019
71079769|NCT01301079|141666700|SUPERIORITY_OR_OTHER|||||||0.652|TWO_SIDED||||||t-test, 2 sided|||||||0.652
71079770|NCT01301079|141666701|SUPERIORITY_OR_OTHER|||||||0.221|TWO_SIDED||||||t-test, 2 sided|||||||0.221
71079771|NCT01301079|141666702|SUPERIORITY_OR_OTHER|||||||0.325|TWO_SIDED||||||t-test, 2 sided|||||||0.325
71079772|NCT01301079|141666703|SUPERIORITY_OR_OTHER|||||||0.386|TWO_SIDED||||||t-test, 2 sided|||||||0.386
71079773|NCT01301079|141666704|SUPERIORITY_OR_OTHER|||||||0.499|TWO_SIDED||||||t-test, 1 sided|||||||0.499
71079774|NCT01301079|141666705|SUPERIORITY_OR_OTHER|||||||0.909|TWO_SIDED||||||t-test, 2 sided|||||||0.909
71079775|NCT01301079|141666706|SUPERIORITY_OR_OTHER|||||||0.737|TWO_SIDED||||||t-test, 2 sided|||||||0.737
71079776|NCT01301079|141666707|SUPERIORITY_OR_OTHER||||||<|0.872|TWO_SIDED||||||t-test, 2 sided|||||||<0.872
71079777|NCT01301079|141666708|SUPERIORITY_OR_OTHER|||||||0.598|TWO_SIDED||||||t-test, 2 sided|||||||0.598
71079778|NCT01301079|141666709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.485|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.485
71079779|NCT01301079|141666710|SUPERIORITY_OR_OTHER|||||||0.744|TWO_SIDED||||||t-test, 2 sided|||||||0.744
71079780|NCT01301079|141666711|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||t-test, 2 sided|||||||0.540
71079781|NCT01301079|141666712|SUPERIORITY_OR_OTHER|||||||0.673|TWO_SIDED||||||t-test, 2 sided|||||||0.673
71079782|NCT01301079|141666713|SUPERIORITY_OR_OTHER|||||||0.586|TWO_SIDED||||||t-test, 2 sided|||||||0.586
71079783|NCT01301079|141666714|SUPERIORITY_OR_OTHER|||||||0.077|TWO_SIDED||||||t-test, 2 sided|||||||0.077
71079784|NCT01301079|141666715|SUPERIORITY_OR_OTHER|||||||0.677|TWO_SIDED||||||t-test, 2 sided|||||||0.677
70942564|NCT03897049|141385150|SUPERIORITY||Mean Difference (Net)|0.09||||0.531|TWO_SIDED||||||Regression, Linear|||||||0.531
70942565|NCT03897049|141385151|SUPERIORITY||Mean Difference (Net)|-0.03||||0.761|TWO_SIDED||||||Regression, Linear|||||||0.761
70942566|NCT03897049|141385152|SUPERIORITY||Mean Difference (Net)|0.11||||0.503|TWO_SIDED||||||Regression, Linear|||||||0.503
71079785|NCT01301079|141666716|SUPERIORITY_OR_OTHER|||||||0.545|TWO_SIDED||||||t-test, 2 sided|||||||0.545
71079786|NCT01301079|141666717|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||t-test, 2 sided|||||||0.650
71079787|NCT01301079|141666718|SUPERIORITY_OR_OTHER|||||||0.593|TWO_SIDED||||||t-test, 2 sided|||||||0.593
71079788|NCT01301079|141666719|SUPERIORITY_OR_OTHER|||||||0.313|TWO_SIDED||||||Chi-squared|||||||0.313
71079789|NCT01301079|141666720|SUPERIORITY_OR_OTHER|||||||0.313|TWO_SIDED||||||Chi-squared|||||||0.313
71079790|NCT01301079|141666721|SUPERIORITY_OR_OTHER|||||||0.313|TWO_SIDED||||||Chi-squared|||||||0.313
71079791|NCT01301079|141666722|SUPERIORITY_OR_OTHER|||||||0.611|TWO_SIDED||||||Chi-squared|||||||0.611
70854248|NCT00594425|141196855|SUPERIORITY_OR_OTHER||Least squares mean|-2.64||||0.3236|TWO_SIDED|95.0|-7.91|2.63||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model including center and baseline lesion count as a covariates. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||2.63|-7.91|0.3236
70942567|NCT03897049|141385153|SUPERIORITY||Mean Difference (Net)|0.01||||0.541|TWO_SIDED||||||Regression, Linear|||||||0.541
71079792|NCT01301079|141666723|SUPERIORITY_OR_OTHER|||||||0.312|TWO_SIDED||||||t-test, 2 sided|||||||0.312
71079793|NCT01301079|141666724|SUPERIORITY_OR_OTHER|||||||0.676|TWO_SIDED||||||t-test, 2 sided|||||||0.676
70854249|NCT00594425|141196855|SUPERIORITY_OR_OTHER||Least squares mean|-1.19||||0.6657|TWO_SIDED|95.0|-6.64|4.26||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model including center and baseline lesion count as a covariates. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||4.26|-6.64|0.6657
70942568|NCT03897049|141385154|SUPERIORITY||Mean Difference (Net)|-0.02||||0.537|TWO_SIDED||||||Regression, Linear|||||||0.537
71079794|NCT01301079|141666725|SUPERIORITY_OR_OTHER|||||||0.938|TWO_SIDED||||||t-test, 2 sided|||||||0.938
71079795|NCT01301079|141666726|SUPERIORITY_OR_OTHER|||||||0.385|TWO_SIDED||||||t-test, 2 sided|||||||0.385
71079796|NCT01301079|141666727|SUPERIORITY_OR_OTHER|||||||0.422|TWO_SIDED||||||t-test, 2 sided|||||||0.422
71079797|NCT01301079|141666728|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.500
70942569|NCT03897049|141385155|SUPERIORITY||Mean Difference (Net)|0.19||||0.057|TWO_SIDED||||||Regression, Linear|||||||0.057
70942570|NCT03897049|141385156|SUPERIORITY||Mean Difference (Net)|0.1||||0.402|TWO_SIDED||||||Regression, Linear|||||||0.402
70942571|NCT03897049|141385157|SUPERIORITY||Mean Difference (Net)|0.15||||0.308|TWO_SIDED||||||Regression, Linear|||||||0.308
71079798|NCT01301079|141666729|SUPERIORITY_OR_OTHER|||||||0.435|TWO_SIDED||||||t-test, 2 sided|||||||0.435
70854250|NCT00594425|141196883|SUPERIORITY_OR_OTHER||%success rate|3.09||||0.7889|TWO_SIDED|95.0|-11.16|17.33||Priori threshold for statistical significance was 5%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel stratified by center. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||17.33|-11.16|0.7889
70942572|NCT03897049|141385158|SUPERIORITY||Mean Difference (Net)|0.48||||0.001|TWO_SIDED||||||Regression, Linear|||||||0.001
70942573|NCT00666835|141385159|EQUIVALENCE|Therapeutic equivalence was defined as the two-sided 95 % confidence interval of the difference between the two treatment groups lying entirely in the interval -0.5 to 0.5 g/dL. The confidence interval of the difference was calculated based on the least square means (LSMEANS) from an analysis of co-variance model including factors treatment, center, mean baseline Hb level (\<11.5 and T11.5 g/dL) as factors and change of the mean weekly dose as a covariate.|Point estimate of difference (ANCOVA)|0.084|||||TWO_SIDED|95.0|-0.17|0.338||||||||0.338|-0.170|
71079799|NCT01301079|141666730|SUPERIORITY_OR_OTHER|||||||0.745|TWO_SIDED||||||t-test, 2 sided|||||||0.745
71079800|NCT01301079|141666731|SUPERIORITY_OR_OTHER|||||||0.557|TWO_SIDED||||||t-test, 2 sided|||||||0.557
71079801|NCT04472494|141666741|SUPERIORITY||Odds Ratio (OR)|1.07||||0.9297|TWO_SIDED|95.0|0.26|4.49|||Cochran-Mantel-Haenszel Chi-Square test|||||4.49|0.26|0.9297
71079802|NCT04472494|141666742|SUPERIORITY||Adjusted mean difference from Placebo|0.64||||0.74|TWO_SIDED|95.0|-0.55|1.82|||Cochran-Mantel-Haenszel|||||1.82|-0.55|0.7400
71079803|NCT04472494|141666743|SUPERIORITY||Estimate of Difference|-0.1||||0.9684|TWO_SIDED|95.0|-20.55|20.34|||Cochran-Mantel-Haenszel Chi-Square test||Estimate of Difference is based on minimum risk weights|||20.34|-20.55|0.9684
71079804|NCT04472494|141666744|SUPERIORITY||Odds Ratio (OR)|0.85||||0.8504|TWO_SIDED|95.0|0.18|3.97|||Cochran-Mantel-Haenszel|||||3.97|0.18|0.8504
71079805|NCT04472494|141666745|SUPERIORITY||Odds Ratio (OR)|2.29||||0.2724|TWO_SIDED|95.0|0.53|9.82|||Cochran-Mantel-Haenszel|||||9.82|0.53|0.2724
71079806|NCT04472494|141666745|SUPERIORITY||Estimate of difference|12.78|||||TWO_SIDED|95.0|-10.61|36.17|||||||Estimate of difference is based on minimum risk weights|36.17|-10.61|
71079807|NCT04472494|141666746|SUPERIORITY||Odds Ratio (OR)|2.03||||0.4734|TWO_SIDED|95.0|0.33|12.64|||Cochran-Mantel-Haenszel|||||12.64|0.33|0.4734
71079808|NCT04472494|141666746|SUPERIORITY||Estimate of difference|5.43|||||TWO_SIDED|95.0|-16.71|27.57|||||Estimate of difference is based on minimum risk weights|||27.57|-16.71|
71079809|NCT00571103|141666750|SUPERIORITY_OR_OTHER||Mean Slope|-0.985|STANDARD_ERROR_OF_MEAN|0.158||0.05|TWO_SIDED|95.0|-1.0|1.0|||Linear mixed effects|||||1|-1|0.05
71079810|NCT02095197|141666814|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||||||0.23
71079811|NCT02095197|141666815|SUPERIORITY_OR_OTHER|||||||0.47|||||||Chi-squared|||||||0.47
71079812|NCT02095197|141666816|SUPERIORITY_OR_OTHER|||||||0.3|||||||Chi-squared|||||||0.30
71079813|NCT02095197|141666817|SUPERIORITY_OR_OTHER|||||||0.41|||||||Chi-squared|||||||0.41
71079814|NCT02020889|141666843|OTHER||Odds Ratio (OR)|5.91|||<|0.001|TWO_SIDED|95.0|2.68|13.03|||Proportional odds regression model|Proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score, region|Mepolizumab 300mg/Placebo|||13.03|2.68|<0.001
71079815|NCT02020889|141666844|OTHER||Odds Ratio (OR)|16.74|||<|0.001|TWO_SIDED|95.0|3.61|77.56|||Regression, Logistic|Logistic regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region|Mepolizumab 300mg/Placebo|||77.56|3.61|<0.001
71079816|NCT02020889|141666845|OTHER||Hazard Ratio (HR)|0.322|||<|0.001|TWO_SIDED|95.0|0.206|0.502|||Cox Proportional Hazard regression|Cox proportional hazards model with covariates of treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region|Mepolizumab 300mg/Placebo|||0.502|0.206|<0.001
71079817|NCT02020889|141666846|OTHER||Odds Ratio (OR)|0.2|||<|0.001|TWO_SIDED|95.0|0.09|0.41|||Proportional odds regression model|Proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score, region|Mepolizumab 300mg/Placebo|||0.41|0.09|<0.001
70954216|NCT00688870|141411074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|9.6|||||TWO_SIDED|95.0|3.8|18.1|||Chan and Zhang|||Additional serotypes - serotype 5||18.1|3.8|
71079818|NCT02020889|141666847|OTHER||Odds Ratio (OR)|19.65||||0.007|TWO_SIDED|95.0|2.3|167.93|||Regression, Logistic|Logistic regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region|Mepolizumab 300mg/Placebo|||167.93|2.30|0.007
71079819|NCT02020889|141666848|OTHER||Odds Ratio (OR)|5.31|||<|0.001|TWO_SIDED|95.0|2.63|10.74|||Proportional odds regression model|Proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score, region|Mepolizumab 300mg/Placebo|||10.74|2.63|<0.001
71079820|NCT02020889|141666849|OTHER||Odds Ratio (OR)|7.19|||<|0.001|TWO_SIDED|95.0|2.6|19.87|||Regression, Logistic|Logistic regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region|Mepolizumab 300mg/Placebo|||19.87|2.60|<0.001
71079821|NCT02020889|141666850|OTHER||Odds Ratio (OR)|11.39||||0.003|TWO_SIDED|95.0|2.35|55.24|||Regression, Logistic|Logistic regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region.|Mepolizumab 300mg/Placebo|||55.24|2.35|0.003
71079822|NCT01690299|141666886|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|27.5|||<|0.0001|TWO_SIDED|95.0|14.9|40.1||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.|||40.1|14.9|< 0.0001
71079823|NCT01690299|141666887|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|35.9|||<|0.0001|TWO_SIDED|95.0|23.3|48.5||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.|||48.5|23.3|<0.0001
71079824|NCT01690299|141666888|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|18.0||||0.0005|TWO_SIDED|95.0|8.4|27.7||The p-value is from a CMH test stratified by the BMI (Body Mass Index) at screening.|Cochran-Mantel-Haenszel|The p-value is from a CMH test stratified by the BMI at screening.|The Confidence Interval (CI) was weighted using CMH weights according to the number of participants in the two strata.|||27.7|8.4|0.0005
71079825|NCT01690299|141666888|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|25.2|||<|0.0001|TWO_SIDED|95.0|14.8|35.5||The p-value is from a CMH test stratified by the BMI (Body Mass Index) at screening.|Cochran-Mantel-Haenszel|The Confidence Interval (CI) was weighted using CMH weights according to the number of participants in the two strata.||||35.5|14.8|<0.0001
71079826|NCT01690299|141666889|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-31.4|||<|0.0001|TWO_SIDED|95.0|-43.33|-19.46|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.||||-19.46|-43.33|<0.0001
71079827|NCT01690299|141666889|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-39.85|||<|0.0001|TWO_SIDED|95.0|-51.78|-27.92|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.||||-27.92|-51.78|<0.0001
71079828|NCT01690299|141666890|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|29.4||||0.0002|TWO_SIDED|95.0|14.9|43.9||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.|||43.9|14.9|0.0002
71079829|NCT01690299|141666890|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|49.8|||<|0.0001|TWO_SIDED|95.0|36.9|62.7||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.|||62.7|36.9|<0.0001
71079830|NCT01690299|141666891|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-4.48|||<|0.0001|TWO_SIDED|95.0|-6.82|-2.14|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.||||-2.14|-6.82|<0.0001
71079831|NCT01690299|141666891|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-3.94||||0.0004|TWO_SIDED|95.0|-6.27|-1.6|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.||||-1.60|-6.27|0.0004
71079832|NCT01690299|141666892|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|0.93||||0.7112|TWO_SIDED|95.0|-2.05|3.9|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.||||3.90|-2.05|0.7112
71079833|NCT01690299|141666892|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|2.22||||0.1719|TWO_SIDED|95.0|-0.75|5.19|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.||||5.19|-0.75|0.1719
71079834|NCT01690299|141666893|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|18.1||||0.0011|TWO_SIDED|95.0|7.6|28.6||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.|||28.6|7.6|0.0011
71079835|NCT01690299|141666893|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|16.7||||0.0021|TWO_SIDED|95.0|6.5|26.9||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.|||26.9|6.5|0.0021
71117852|NCT05425732|141740600|OTHER|cLDA model|GMC Ratio|6.79|||||TWO_SIDED|95.0|6.03|7.64|||||V116/PCV20|Serotype 15A: V116/PCV20 GMC Ratio||7.64|6.03|
71117853|NCT05425732|141740600|OTHER|cLDA model|GMC Ratio|2.46|||||TWO_SIDED|95.0|2.17|2.79|||||V116/PCV20|Serotype 15C: V116/PCV20 GMC Ratio||2.79|2.17|
71117854|NCT05425732|141740600|OTHER|cLDA model|GMC Ratio|8.75|||||TWO_SIDED|95.0|7.95|9.64|||||V116/PCV20|Serotype 16F: V116/PCV20 GMC Ratio||9.64|7.95|
71117855|NCT05425732|141740600|OTHER|cLDA model|GMC Ratio|16.75|||||TWO_SIDED|95.0|15.25|18.41|||||V116/PCV20|Serotype 17F: V116/PCV20 GMC Ratio||18.41|15.25|
71117856|NCT05425732|141740600|OTHER|cLDA model|GMC Ratio|12.92|||||TWO_SIDED|5.0|11.81|14.13|||||V116/PCV20|Serotype 20A: V116/PCV20 GMC Ratio||14.13|11.81|
71117857|NCT05425732|141740600|OTHER|cLDA model|GMC Ratio|6.42|||||TWO_SIDED|95.0|5.69|7.24|||||V116/PCV20|Serotype 23A: V116/PCV20 GMC Ratio||7.24|5.69|
71117858|NCT05425732|141740600|OTHER|cLDA model|GMC Ratio|3.25|||||TWO_SIDED|95.0|2.91|3.64|||||V116/PCV20|Serotype 23B: V116/PCV20 GMC Ratio||3.64|2.91|
70942574|NCT00666835|141385160|EQUIVALENCE|Therapeutic equivalence was defined as the two-sided 95 % confidence interval of the difference between the two treatment groups lying entirely in the interval -0.5 to 0.5 g/dL. The confidence interval of the difference was calculated based on the least square means (LSMEANS) from an analysis of co-variance model including factors treatment, center, mean baseline Hb level (\<11.5 and T11.5 g/dL) as factors and change of the mean weekly dose as a covariate.|Difference LSM of Epo Hexal & Erypo|0.189|||||TWO_SIDED|95.0|-0.039|0.418||||||||0.418|-0.039|
70942575|NCT03319719|141385165|SUPERIORITY||Mean Difference (Net)|-2.88|||<|0.0001|TWO_SIDED|95.0|-3.42|-2.33||p-value from paired two-sided t-tests of no difference between test and control groups.|t-test, 2 sided|||||-2.33|-3.42|<0.0001
71079836|NCT01461473|141666916|SUPERIORITY_OR_OTHER|||||||0.2067|||||||Analysis of covariance (GLM)|||These data were analyzed using an analysis of covariance via general linear model (GLM). The GLM has an indicator variable for PAP vs. OA plus covariates for baseline apnea-hypopnea index, gender, site and baseline NMAP. The primary hypothesis tested is that the 2-month means differ between study arms, after adjustment for the above covariates. A Wald statistic was constructed for hypothesis testing.||||0.2067
71079837|NCT01461473|141666917|SUPERIORITY_OR_OTHER|||||||0.3902|||||||GLMM|||Generalized linear mixed model (GLMM) was fit in which the outcome was regressed on an indicator variable for PAP vs. OA, baseline apnea-hypopnea index, gender, site and baseline value of the outcome. A Wald statistic was constructed for hypothesis testing.||||0.3902
70942576|NCT01212952|141385171|OTHER||Maximum Tolerated Dose (MTD) (mg/m^2)|1.3|||||TWO_SIDED||||||||Maximum Tolerated Dose Level is Dose Level 2 (1.3 mg/m\^2 Bortezomib).|||||
70942577|NCT02236598|141385179|SUPERIORITY|||||||0.5582|||||||ANCOVA|||||||0.5582
70942578|NCT02236598|141385180|SUPERIORITY|Change in Fasting Glucose||||||0.0963|||||||ANCOVA|||||||0.0963
70942579|NCT02236598|141385180|SUPERIORITY|Change in 1-hour Glucose||||||0.6671|||||||ANCOVA|||||||0.6671
70942580|NCT02236598|141385180|SUPERIORITY|Change in 2-hour Glucose||||||0.7913|||||||ANCOVA|||||||0.7913
70942581|NCT02236598|141385181|SUPERIORITY|||||||0.5294|||||||ANCOVA|||||||0.5294
70942582|NCT02236598|141385182|SUPERIORITY|||||||0.1604|||||||ANCOVA|||||||0.1604
70942583|NCT02959177|141385194|SUPERIORITY||LSMean Difference|-3.01|||<|0.001|TWO_SIDED|95.0|-3.8|-2.22|||Mixed Models Analysis|||||-2.22|-3.80|<0.001
71079838|NCT01461473|141666918|SUPERIORITY_OR_OTHER|||||||0.9319|||||||GLMM|||A GLMM was fit in which the outcome was regressed on an indicator variable for PAP vs. OA, baseline apnea-hypopnea index, gender, site and baseline value of the outcome. A Wald statistic was constructed for hypothesis testing.||||0.9319
70942584|NCT02959177|141385194|SUPERIORITY||Mean Difference (Final Values)|-2.7|||<|0.001|TWO_SIDED|95.0|-3.53|-1.94|||Mixed Models Analysis|||||-1.94|-3.53|<0.001
70942585|NCT02959177|141385195|SUPERIORITY||Odds Ratio (OR)|3.89|||||TWO_SIDED|95.0|2.71|5.57||||||||5.57|2.71|
71117859|NCT05425732|141740600|OTHER|cLDA model|GMC Ratio|21.08|||||TWO_SIDED|85.0|18.97|23.43|||||V116/PCV20|Serotype 24F: V116/PCV20 GMC Ratio||23.43|18.97|
71117860|NCT05425732|141740600|OTHER|cLDA model|GMC Ratio|11.31|||||TWO_SIDED|95.0|10.36|12.34|||||V116/PCV20|Serotype 31: V116/PCV20 GMC Ratio||12.34|10.36|
71117861|NCT05425732|141740600|OTHER|cLDA model|GMC Ratio|14.13|||||TWO_SIDED|95.0|12.97|15.4|||||V116/PCV20|Serotype 35B: V116/PCV20 GMC Ratio||15.40|12.97|
71117862|NCT00306293|141740609|SUPERIORITY_OR_OTHER||Percent change from Placebo|-78.0|||<|0.001||95.0|||||Wilcoxon Rank Sum Test||Percent change in days with Subclinical HSV-2 Viral Shedding after VALTREX 1g treatment from the placebo|||||<0.001
71117863|NCT00306293|141740610|SUPERIORITY_OR_OTHER||Percent change from Baseline|-77.0||||0.014||95.0|||||Wilcoxon Rank Sum||Percent change in 'percentage of days with clinical HSV-2 viral shedding', after VALTREX 1g treatment from the placebo|||||0.014
71117864|NCT01120236|141740622|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.24||||0.16|TWO_SIDED||||||Fisher Exact||Arm I (Androgen Deprivation and Cixutumumab) represents the numerator and Arm II (Androgen Deprivation Therapy) represents the denominator for relative risk.|An intention-to-treat approach was used in analysis of the primary endpoint. A 45% undetectable PSA \<= 0.2 ng/mL rate at 28 weeks was assumed for (control) arm II , based on data from SWOG 9346. Using a one-sided type I error rate of 0.10, we had 90% statistical power to detect an absolute difference of 20% in the undetectable PSA rate with the addition of cixutumumab using Fisher's exact test.||||0.16
71117865|NCT01120236|141740624|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.82||||0.11|TWO_SIDED||||||Fisher Exact||Arm I (Androgen Deprivation and Cixutumumab) represents the numerator and Arm II (Androgen Deprivation Therapy) represents the denominator for relative risk.|Proportion of patients in each arm with PSA \> 4 ng/mL after seven cycles of protocol treatment were compared.||||0.11
71117866|NCT04187144|141740633|NON_INFERIORITY|The difference in success rate between treatment groups (gepotidacin - nitrofurantoin) was calculated using Miettinen-Nurminen Summary Score Method adjusted for age group and acute cystitis recurrence strata combinations. Criteria for non-inferiority is if the Z-statistic for non-inferiority is greater than the 2.098 Z-statistic boundary.|Adjusted Difference in Percent|14.6|||||TWO_SIDED|95.0|6.4|22.8|||||||Observed Z statistic value for Noninferiority was 5.8838.|22.8|6.4|
71117867|NCT04187144|141740633|SUPERIORITY||Adjusted difference in Percent|14.6||||0.0003|TWO_SIDED|95.0|6.4|22.8|||1-sided p-value for Test of Superiority|||The difference in success rate between treatment groups (gepotidacin - nitrofurantoin) was calculated using Miettinen-Nurminen Summary Score Method adjusted for age group and acute cystitis recurrence strata combinations. Criteria for superiority is if the one-sided p-value is less than the 0.018 p-value boundary||22.8|6.4|0.0003
71117868|NCT02383420|141740678|SUPERIORITY_OR_OTHER|||||||0.415|TWO_SIDED|||||Level of significance (alpha) = 0.05|t-test, 2 sided|||||||0.415
71117869|NCT02383420|141740679|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||Level of significance (alpha) = 0.05|t-test, 1 sided|||||||0.0000
71117870|NCT02526524|141740695|SUPERIORITY||LS Mean|-0.27|STANDARD_ERROR_OF_MEAN|0.184||0.1449|TWO_SIDED|95.0|-0.63|0.09|||Mixed Models Analysis|Included treatment, visit, and treatment-by-visit interaction as fixed effects, and HbA1c value at Baseline as a covariate.||||0.09|-0.63|0.1449
71117871|NCT02526524|141740695|SUPERIORITY||LS Mean|-0.33|STANDARD_ERROR_OF_MEAN|0.18||0.0643|TWO_SIDED|95.0|-0.69|0.02|||Mixed Models Analysis|Included treatment, visit, and treatment-by-visit interaction as fixed effects, and HbA1c value at Baseline as a covariate.||||0.02|-0.69|0.0643
71117872|NCT02526524|141740695|SUPERIORITY||LS Means|-0.42|STANDARD_ERROR_OF_MEAN|0.184||0.0214|TWO_SIDED|95.0|-0.79|-0.06|||Mixed Models Analysis|Included treatment, visit, and treatment-by-visit interaction as fixed effects, and HbA1c value at Baseline as a covariate.||||-0.06|-0.79|0.0214
71117873|NCT02526524|141740695|SUPERIORITY||LS Mean|-0.55|STANDARD_ERROR_OF_MEAN|0.18||0.0022|TWO_SIDED|95.0|-0.91|-0.2|||Mixed Models Analysis|Included treatment, visit, and treatment-by-visit interaction as fixed effects, and HbA1c value at Baseline as a covariate.||||-0.20|-0.91|0.0022
71117874|NCT02526524|141740695|SUPERIORITY||LS Mean|-1.03|STANDARD_ERROR_OF_MEAN|0.184|<|0.0001|TWO_SIDED|95.0|-1.39|-0.67|||Mixed Models Analysis|Included treatment, visit, and treatment-by-visit interaction as fixed effects, and HbA1c value at Baseline as a covariate.||||-0.67|-1.39|<0.0001
71117875|NCT05312632|141740704|OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
71117876|NCT05312632|141740705|OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
71117877|NCT05312632|141740706|OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
70942586|NCT02959177|141385195|SUPERIORITY||Odds Ratio (OR)|3.664|||||TWO_SIDED|95.0|2.54|5.23||||||||5.23|2.54|
70942587|NCT02959177|141385196|SUPERIORITY||Odds Ratio (OR)|3.24|||||TWO_SIDED|95.0|2.14|4.89||||||||4.89|2.14|
70942588|NCT02959177|141385196|SUPERIORITY||Odds Ratio (OR)|3.16|||||TWO_SIDED|95.0|2.08|4.8||||||||4.80|2.08|
70942589|NCT02959177|141385197|SUPERIORITY||Odds Ratio (OR)|3.47|||||TWO_SIDED|95.0|2.03|5.93||||||||5.93|2.03|
70942590|NCT02959177|141385197|SUPERIORITY||Odds Ratio (OR)|3.13|||||TWO_SIDED|95.0|1.79|5.44||||||||5.44|1.79|
71117878|NCT05312632|141740707|OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
71117879|NCT05312632|141740708|OTHER|||||||0.013|||||||Wilcoxon signed rank test|||||||0.013
71117880|NCT05312632|141740709|OTHER|||||||0.053|||||||Wilcoxon signed rank test|||||||0.053
71117881|NCT05312632|141740710|OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
71117882|NCT02019108|141740712|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.495|TWO_SIDED|95.0|-1.1|0.5||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||0.5|-1.1|0.495
70942591|NCT02959177|141385198|SUPERIORITY||LSMean difference|7.0|||<|0.001|TWO_SIDED|95.0|4.54|9.46|||Mixed Models Analysis|||||9.46|4.54|<0.001
70942592|NCT02959177|141385198|SUPERIORITY||Mean Difference (Final Values)|5.79|||<|0.01|TWO_SIDED|95.0|3.33|8.24|||Mixed Models Analysis|||||8.24|3.33|<0.01
70942593|NCT02959177|141385199|SUPERIORITY||LSMean difference|-2.9|||<|0.001|TWO_SIDED|95.0|-3.61|-2.19|||Mixed Models Analysis|||||-2.19|-3.61|<0.001
70942594|NCT02959177|141385199|SUPERIORITY||LSMean difference|-2.7|||<|0.001|TWO_SIDED|95.0|-3.41|-1.99|||Mixed Models Analysis|||||-1.99|-3.41|<0.001
70942595|NCT02959177|141385201|SUPERIORITY||LSMean Difference|-11.82|||<|0.001|TWO_SIDED|95.0|-16.14|-7.51|||Mixed Models Analysis|||||-7.51|-16.14|<0.001
70942596|NCT02959177|141385201|SUPERIORITY||LSMean difference|-13.73|||<|0.001|TWO_SIDED|95.0|-18.05|-9.4|||Mixed Models Analysis|||||-9.40|-18.05|<0.001
70942597|NCT02959177|141385202|SUPERIORITY||LSMean Difference|-4.9|||<|0.001|TWO_SIDED|95.0|-8.06|-1.73|||Mixed Models Analysis|||||-1.73|-8.06|<0.001
70942598|NCT02959177|141385202|SUPERIORITY||LSMean Difference|-2.97|||<|0.001|TWO_SIDED|95.0|-6.08|0.14|||Mixed Models Analysis|||||0.14|-6.08|<.001
70942599|NCT01947153|141385209|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|102.92|STANDARD_ERROR_OF_MEAN|1.027|<|0.0001|TWO_SIDED|90.0|98.37|107.688||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||107.688|98.370|<0.0001
70942600|NCT01947153|141385210|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|105.14|STANDARD_ERROR_OF_MEAN|1.032|<|0.0001|TWO_SIDED|90.0|99.645|110.941||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||110.941|99.645|<0.0001
71117883|NCT02019108|141740712|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.079|TWO_SIDED|95.0|-1.6|0.1||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||0.1|-1.6|0.079
71117884|NCT02019108|141740713|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.117|TWO_SIDED|95.0|-2.6|0.3||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||0.3|-2.6|0.117
71117885|NCT02019108|141740713|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.133|TWO_SIDED|95.0|-2.5|0.3||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||0.3|-2.5|0.133
71117886|NCT02019108|141740714|SUPERIORITY||Median Difference (Final Values)|-0.14||||0.125|TWO_SIDED|95.0|-0.31|0.04||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks||0.04|-0.31|0.125
71117887|NCT02019108|141740714|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.103|TWO_SIDED|95.0|-0.37|0.03||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks||0.03|-0.37|0.103
71117888|NCT02019108|141740715|SUPERIORITY||Mean Difference (Final Values)|-0.26|||<|0.001|TWO_SIDED|95.0|-0.39|-0.12||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||-0.12|-0.39|<0.001
71117889|NCT02019108|141740715|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.056|TWO_SIDED|95.0|-0.4|0.01||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||0.01|-0.40|0.056
71117890|NCT02019108|141740716|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.031|TWO_SIDED|95.0|-0.11|-0.01||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||-0.01|-0.11|0.031
70942601|NCT01947153|141385211|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|109.05|STANDARD_ERROR_OF_MEAN|1.063||0.0014|TWO_SIDED|90.0|98.299|120.968||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||120.968|98.299|0.0014
70942602|NCT01947153|141385212|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|105.81|STANDARD_ERROR_OF_MEAN|1.043|<|0.0001|TWO_SIDED|90.0|98.471|113.692||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||113.692|98.471|<0.0001
70942603|NCT01947153|141385213|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.48|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|TWO_SIDED|90.0|92.177|105.208||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||105.208|92.177|<0.0001
70942604|NCT01947153|141385214|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|104.62|STANDARD_ERROR_OF_MEAN|1.031|<|0.0001|TWO_SIDED|90.0|99.274|110.254||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||110.254|99.274|<0.0001
70942605|NCT01947153|141385215|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|102.92|STANDARD_ERROR_OF_MEAN|1.027|<|0.0001|TWO_SIDED|90.0|98.37|107.688||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||107.688|98.370|<0.0001
70942606|NCT01061775|141385216|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||.05
71079839|NCT01461473|141666919|SUPERIORITY_OR_OTHER|||||||0.3895|||||||GLMM|||A GLMM was fit in which the outcome was regressed on an indicator variable for PAP vs. OA, baseline apnea-hypopnea index, gender, site and baseline value of the outcome. A Wald statistic was constructed for hypothesis testing.||||0.3895
71079840|NCT01461473|141666920|SUPERIORITY_OR_OTHER|||||||0.3449|||||||see Comments|Analysis of covariance with robust MM regression due to extreme residuals from initial fit showing strong departure from normal distribution.||Using analysis of covariance (robust MM regression), the outcome was regressed on an indicator variable for PAP vs. OA, baseline outcome, baseline apnea-hypopnea index, gender, site, baseline brachial-artery diameter, body mass index, age, and the interaction of gender and study arm. The latter allows for the possibility that treatment effect may differ between males and females. A Wald statistic was constructed for hypothesis testing.||||0.3449
71079841|NCT01461473|141666921|SUPERIORITY_OR_OTHER|||||||0.1531|||||||see Comments|Analysis of covariance with robust MM regression due to extreme residuals from initial fit showing strong departure from normal distribution.||Using analysis of covariance (robust MM regression), the outcome was regressed on an indicator variable for PAP vs. OA, baseline outcome, baseline apnea-hypopnea index, gender, site, baseline brachial-artery diameter, body mass index, age, and the interaction of gender and study arm. The latter allows for the possibility that treatment effect may differ between males and females. A Wald statistic was constructed for hypothesis testing.||||0.1531
71079842|NCT01778751|141666960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.012|TWO_SIDED|95.0|-1.7|-0.2|||Mixed Models Analysis|||Comparison at 3 months||-0.2|-1.7|0.012
71079843|NCT01778751|141666960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.05|TWO_SIDED|95.0|-2.0|0.0|||Mixed Models Analysis|||Comparison at 6 months||-0.0|-2.0|0.050
71079844|NCT01778751|141666961|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9||||0.303|TWO_SIDED|95.0|-2.7|8.4|||Mixed Models Analysis|||Comparison at 3 months, Scale is 0-100 where a higher score is a better outcome.||8.4|-2.7|0.303
71079845|NCT01778751|141666961|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.7||||0.027|TWO_SIDED|95.0|0.9|14.4|||Mixed Models Analysis|||Comparison at 6 months, Scale is 0-100 where a higher score is a better outcome.||14.4|0.9|0.027
71079846|NCT01778751|141666962|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.83|TWO_SIDED|95.0|0.35|2.34|||Generalized estimating equation (GEE)|||||2.34|0.35|0.830
71079847|NCT01778751|141666962|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.97|TWO_SIDED|95.0|0.33|3.19|||Generalized Estimating Equation (GEE)|||Comparison at 6 months||3.19|0.33|0.970
71117891|NCT02019108|141740716|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.058|TWO_SIDED|95.0|-0.12|0.0||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||0.00|-0.12|0.058
71117892|NCT02019108|141740717|SUPERIORITY||Mean Difference (Final Values)|-9.04|||<|0.001|TWO_SIDED|95.0|-11.22|-6.86||a priori threshold for statistical significance \<0.05.|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||-6.86|-11.22|<0.001
71117893|NCT02019108|141740717|SUPERIORITY||Mean Difference (Final Values)|-6.78|||<|0.001|TWO_SIDED|95.0|-8.82|-4.75||a priori threshold for statistical significance \<0.05.|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||-4.75|-8.82|<0.001
71117894|NCT02019108|141740718|SUPERIORITY||Mean Difference (Final Values)|-3.7||||0.111|TWO_SIDED|95.0|-8.3|0.9||a priori threshold for statistical significance \<0.05.|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||0.9|-8.3|0.111
71117895|NCT02019108|141740718|SUPERIORITY||Mean Difference (Final Values)|-2.7||||0.232|TWO_SIDED|95.0|-7.3|1.8||a priori threshold for statistical significance \<0.05.|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||1.8|-7.3|0.232
71117896|NCT02019108|141740719|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.462|TWO_SIDED|95.0|-0.36|0.78||a priori threshold for significance \<0.05.|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||0.78|-0.36|0.462
71117897|NCT02019108|141740719|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.737|TWO_SIDED|95.0|-0.76|0.54||a priori threshold for statistical significance \<0.05.|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||0.54|-0.76|0.737
71117898|NCT02019108|141740720|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.876|TWO_SIDED|95.0|-0.5|0.43||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||0.43|-0.50|0.876
71117899|NCT02019108|141740720|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.897|TWO_SIDED|95.0|-0.43|0.49||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||0.49|-0.43|0.897
71117900|NCT01466660|141740751|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.822||||0.0891|TWO_SIDED|95.0|0.655|1.032||p-value was not adjusted for multiple comparisons|Log Rank|Stratified by Epidermal Growth Factor Receptor (EGFR) mutation group and presence of brain metastases at baseline|A Cox proportional hazards model, stratified by EGFR mutation group and presence of baseline brain metastases was used to estimate the hazard ratio calculated as Afatinib divided by Gefitinib.|Exploratory trial, no formal hypotheses were tested.||1.032|0.655|0.0891
71117901|NCT01466660|141740752|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.0136|TWO_SIDED|95.0|0.595|0.944||p-value was not adjusted for multiple comparisons|Log Rank|Stratified by EGFR mutation group and presence of brain metastases at baseline|Ratio calculated as Afatinib divided by Gefitinib|Exploratory trial, no formal hypotheses were tested.||0.944|0.595|0.0136
71117902|NCT01466660|141740753|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.862||||0.2343|TWO_SIDED|95.0|0.674|1.101||p-value was not adjusted for multiple comparisons|Log Rank|Stratified by EGFR mutation group and presence of brain metastases at baseline|A Cox proportional hazards model, stratified by EGFR mutation group and presence of baseline brain metastases was used to estimate the hazard ratio calculated as Afatinib divided by Gefitinib.|Exploratory trial, no formal hypotheses were tested.||1.101|0.674|0.2343
70854251|NCT00594425|141196883|SUPERIORITY_OR_OTHER||Percent success|5.48||||0.888|TWO_SIDED|95.0|-10.15|21.11||Priori threshold for statistical significance was 5%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by center. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||21.11|-10.15|0.8880
70942607|NCT01061775|141385217|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
70942608|NCT01061775|141385218|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
70942609|NCT01061775|141385219|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
70942610|NCT04089332|141385258|OTHER||Slope|-0.4465||||0.162|TWO_SIDED||||||Regression, Linear|||WASI II (Verbal IQ) vs HOMA-IR|Adjusted R-squared = 0.117|||0.162
70942611|NCT04089332|141385258|OTHER||Slope|0.6704||||0.082|TWO_SIDED||||||Regression, Linear|||WASI II (Performance IQ) vs HOMA-IR|Adjusted R-squared = 0.221|||0.082
70942612|NCT04089332|141385258|OTHER||Slope|-0.8486||||0.286|TWO_SIDED||||||Regression, Linear|||NIH Toolbox (Flanker Inhibitory Control and Attention) vs HOMA-IR|Adjusted R-squared = 0.0503|||0.286
70942613|NCT04089332|141385258|OTHER||Slope|-0.0266||||0.635|TWO_SIDED||||||Regression, Linear|||NIH Toolbox (Pattern Comparison) vs HOMA-IR|Adjusted R-squared = 0|||0.635
70942614|NCT04089332|141385258|OTHER||Slope|-0.1588||||0.061|TWO_SIDED||||||Regression, Linear|||NIH Toolbox (Picture Sequence) vs HOMA-IR|Adjusted R-squared = 0.381|||0.061
70942615|NCT04089332|141385258|OTHER||Slope|0.099||||0.479|TWO_SIDED||||||Regression, Linear|||WRAML (Picture Memory) vs. HOMA-IR|Adjusted R-squared = 0|||0.479
70942616|NCT04089332|141385258|OTHER||Slope|0.0676||||0.965|TWO_SIDED||||||Regression, Linear|||D-KEFS (Color-Word Interference) vs. HOMA-IR|Adjusted R-squared = 0|||0.965
70942617|NCT04089332|141385258|OTHER||Slope|-0.0091||||0.039|TWO_SIDED||||||Regression, Linear|||D-KEFS (Trail Making Test) vs. HOMA-IR|Adjusted R-squared = 0.324|||0.039
71117903|NCT01466660|141740754|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.307||||0.3235|TWO_SIDED|95.0|0.768|2.223||p-value was not adjusted for multiple comparisons|Regression, Logistic|Stratified for EGFR mutation group and presence of brain metastases at baseline|Ratio calculated as Afatinib divided by Gefitinib|Exploratory trial, no formal hypotheses were tested.||2.223|0.768|0.3235
71117904|NCT01466660|141740757|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.138||||0.7856|TWO_SIDED|95.0|0.447|2.896||p-value was not adjusted for multiple comparisons|Regression, Logistic|Stratified for EGFR mutation group and presence of brain metastases at baseline|Ratio calculated as Afatinib divided by Gefitinib|Exploratory trial, no formal hypotheses were tested.||2.896|0.447|0.7856
71117905|NCT01466660|141740759|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.45|STANDARD_ERROR_OF_MEAN|1.87||0.0657|TWO_SIDED|95.0|-7.13|0.23||p-value was not adjusted for multiple comparisons|ANCOVA|Adjusted for baseline sum of diameters, EGFR mutation group and presence of brain metastases at baseline|Difference calculated as Afatinib minus Gefitinib|Exploratory trial, no formal hypotheses were tested.||0.23|-7.13|0.0657
70942618|NCT04089332|141385258|OTHER||Slope|-4.2085||||0.018|TWO_SIDED||||||Regression, Linear|||PedsQL (Child 8-12 / Teen 13-18) vs. HOMA-IR|Adjusted R-squared = 0.0423|||0.018
70942619|NCT04089332|141385259|OTHER||Slope|-1.1138||||0.558|TWO_SIDED||||||Regression, Linear|||Change in Gray Matter Perfusion vs. HOMA-IR|Adjusted R-square = 0|||0.558
70942620|NCT04089332|141385259|OTHER||Slope|-5.8089||||0.057|TWO_SIDED||||||Regression, Linear|||Baseline Gray Matter vs. HOMA-IR|Adjusted R-squared = 0.18|||0.057
70942621|NCT04089332|141385260|OTHER||Slope|-0.4465||||0.377|TWO_SIDED||||||Regression, Linear|||WASI II (Verbal IQ) vs. Cerebral Blood Flow|Adjusted R-squared = 0|||0.377
70942622|NCT04089332|141385260|OTHER||Slope|0.6704||||0.402|TWO_SIDED||||||Regression, Linear|||WASI II (Performance IQ) vs. Cerebral Blood Flow|Adjusted R-squared = 0|||0.402
70942623|NCT04089332|141385260|OTHER||Slope|-0.8486||||0.203|TWO_SIDED||||||Regression, Linear|||NIH Toolbox (Flanker Inhibitory Control and Attention) vs. Cerebral Blood Flow|Adjusted R-squared = 0.207|||0.203
70942624|NCT04089332|141385260|OTHER||Slope|-0.0266||||0.967|TWO_SIDED||||||Regression, Linear|||NIH Toolbox (Pattern Comparison) vs. Cerebral Blood Flow|Adjusted R-squared = 0|||0.967
70942625|NCT04089332|141385260|OTHER||Slope|-0.1588||||0.616|TWO_SIDED||||||Regression, Linear|||NIH Toolbox (Picture Sequence) vs. Cerebral Blood Flow|Adjusted R-squared = 0|||0.616
70942626|NCT04089332|141385260|OTHER||Slope|0.099||||0.287|TWO_SIDED||||||Regression, Linear|||WRAML (Picture Memory) vs. Cerebral Blood Flow|Adjusted R-squared = 0.0497|||0.287
70942627|NCT04089332|141385260|OTHER||Slope|0.0676||||0.225|TWO_SIDED||||||Regression, Linear|||D-KEFS (Color-Word Interference) vs. Cerebral Blood Flow|Adjusted R-squared = 0.106|||0.225
70942628|NCT04089332|141385260|OTHER||Slope|-0.0091||||0.872|TWO_SIDED||||||Regression, Linear|||D-KEFS (Trail Making Test) vs. Cerebral Blood Flow|Adjusted R-squared = 0|||0.872
70942629|NCT04089332|141385260|OTHER||Slope|-4.2085||||0.66|TWO_SIDED||||||Regression, Linear|||PedsQL (Child 8-12 / Teen 13-18) vs. Cerebral Blood Flow|Adjusted R-squared = 0|||0.66
70942630|NCT03418701|141385265|SUPERIORITY||Mean Difference (Final Values)|2.67|||<|0.05|TWO_SIDED|95.0|0.93|4.4|||t-test, 2 sided|||||4.40|0.93|<0.05
70942631|NCT03418701|141385266|SUPERIORITY||Odds Ratio, log|0.47|||<|0.05|TWO_SIDED|95.0|0.22|1.15|||Mixed Models Analysis|A multilevel logistic regression with participants nested within clinic.||||1.15|0.22|<0.05
70942632|NCT04754594|141385273|OTHER||Geometric mean ratio|0.67|||||TWO_SIDED|95.0|0.5|0.9||||||GMRs and 2-sided 95% CIs was calculated by exponentiating the mean difference of the logarithms of the assay and the corresponding CIs.||0.90|0.50|
70942633|NCT04754594|141385274|OTHER||Geometric mean ratio|1.27|||||TWO_SIDED|95.0|0.91|1.77||||||GMRs and 2-sided 95% CIs was calculated by exponentiating the mean difference of the logarithms of the assay and the corresponding CIs.||1.77|0.91|
70942634|NCT04754594|141385274|OTHER||Geometric mean ratio|0.95|||||TWO_SIDED|95.0|0.69|1.3||||||GMRs and 2-sided 95% CIs was calculated by exponentiating the mean difference of the logarithms of the assay and the corresponding CIs.||1.30|0.69|
70942635|NCT04754594|141385275|OTHER|Vaccine efficacy was estimated by 100\*(1 - illness rate ratio \[IRR\]), where IRR=calculated ratio of confirmed COVID-19 illness per 1000 person-years of blinded follow-up in the active vaccine group to the corresponding illness rate in the placebo group.|Vaccine efficacy|3.8|||||TWO_SIDED|95.0|-1227.8|93.0||||||||93.0|-1227.8|
70942636|NCT04754594|141385276|OTHER|Vaccine efficacy was estimated by 100\*(1 - IRR), where IRR=calculated ratio of confirmed COVID-19 illness per 1000 person-years of blinded follow-up in the active vaccine group to the corresponding illness rate in the placebo group.|Vaccine efficacy|35.1|||||TWO_SIDED|95.0|-466.5|94.6||||||||94.6|-466.5|
70942637|NCT04754594|141385277|OTHER|Vaccine efficacy was estimated by 100\*(1 - IRR), where IRR=calculated ratio of confirmed COVID-19 illness per 1000 person-years of blinded follow-up in the active vaccine group to the corresponding illness rate in the placebo group.|Vaccine efficacy|40.9|||||TWO_SIDED|95.0|-104.9|86.5||||||||86.5|-104.9|
70942638|NCT00581009|141385310|EQUIVALENCE|repeated measure ANOVA|t-value|3.34|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
70942639|NCT02849509|141385311|OTHER||||||<|0.0001||||||p-value of paired t-test compared to baseline|Paired t-test|||Convenience dimension score of PACT-Q2 at the second assessment (Visit 2) were compared with the baseline assessment (Visit 1). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||<0.0001
70942640|NCT02849509|141385311|OTHER|||||||0.0174||||||p-value of paired t-test compared to baseline|Paired t-test|||Satisfaction dimension score of PACT-Q2 at the second assessment (Visit 2) were compared with the baseline assessment (Visit 1). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.0174
70942641|NCT02849509|141385312|OTHER||||||<|0.0001||||||p-value of paired t-test compared to baseline|Paired t-test|||Convenience dimension score of PACT-Q2 at the last assessment (Visit 3) were compared with the baseline assessment (Visit 1). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||<0.0001
71079848|NCT01778751|141666963|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.428|TWO_SIDED|95.0|-3.3|1.4|||Mixed Models Analysis|||Comparison at 3 months. Scale is 0-27 where a lower score is a better outcome, values were dichotomized to indicate whether or not the patient was depressed.||1.4|-3.3|0.428
70942642|NCT02849509|141385312|OTHER|||||||0.0004||||||p-value of paired t-test compared to baseline|Paired t-test|||Satisfaction dimension score of PACT-Q2 at the last assessment (Visit 3) were compared with the baseline assessment (Visit 1). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.0004
71117906|NCT01466660|141740760|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.017||0.1422|TWO_SIDED|95.0|-0.06|0.01||p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Adjusted for EGFR mutation group and presence of brain metastases at baseline|Difference calculated as Afatinib minus Gefitinib|"EQ-5D UK utility score.~Exploratory trial, no formal hypotheses were tested."||0.01|-0.06|0.1422
71117907|NCT01466660|141740760|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.016||0.054|TWO_SIDED|95.0|-0.06|0.0||p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Adjusted for EGFR mutation group and presence of brain metastases at baseline|Difference calculated as Afatinib divided by Gefitinib|"EQ-5D Belgium utility score.~Exploratory trial, no formal hypotheses were tested."||0.00|-0.06|0.0540
71117908|NCT01466660|141740760|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|1.21||0.2032|TWO_SIDED|95.0|-3.9|0.8||p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Adjusted for EGFR mutation group and presence of brain metastases at baseline|Difference calculated as Afatinib divided by Gefitinib|"EQ-VAS utility score.~Exploratory trial, no formal hypotheses were tested."||0.8|-3.9|0.2032
71117909|NCT00191724|141740762|SUPERIORITY_OR_OTHER|||||||0.528||95.0||||P-value for effect of drotrecogin alfa (activated) dose in right ventricular function at Day 6|Regression, Linear|||||||0.528
71117910|NCT00191724|141740762|SUPERIORITY_OR_OTHER|||||||0.23||95.0||||P-value for effect of drotrecogin alfa (activated) dose on right ventricular function at Day 90|Regression, Linear|||||||0.230
71117911|NCT00191724|141740763|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||P-value for Dyspnea 90-Day Follow-Up.|Regression, Linear|||||||0.018
71117912|NCT00191724|141740763|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||P-value for Emotional 90 Day Follow-up.|Regression, Linear|||||||0.720
71117913|NCT00191724|141740763|SUPERIORITY_OR_OTHER|||||||0.481||95.0||||P-value for Fatigue 90 Day Follow-Up.|Regression, Linear|||||||0.481
71117914|NCT00191724|141740763|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-value for Mastery 90 Day Follow-Up.|Regression, Linear|||||||0.161
71117915|NCT00191724|141740763|SUPERIORITY_OR_OTHER|||||||0.068||95.0||||P-value for Dyspnea 90 Day Follow-Up.|Regression, Linear|||||||0.068
71117916|NCT00191724|141740763|SUPERIORITY_OR_OTHER|||||||0.985||95.0||||P-value for Emotional 90 Day Follow-Up.|Regression, Linear|||||||0.985
71117917|NCT00191724|141740763|SUPERIORITY_OR_OTHER|||||||0.281||95.0||||P-value for Fatigue 90 Day Follow-Up|Regression, Linear|||||||0.281
71117918|NCT00191724|141740763|SUPERIORITY_OR_OTHER|||||||0.273||95.0||||P-value for Mastery 90 Day Follow-Up|Regression, Linear|||||||0.273
71117919|NCT00191724|141740763|SUPERIORITY_OR_OTHER|||||||0.848||95.0||||P-value for Dyspnea 90 Day Follow-Up.|Regression, Linear|||||||0.848
71117920|NCT00191724|141740763|SUPERIORITY_OR_OTHER|||||||0.841||95.0||||P-value for Emotional 90 Day Follow-Up.|Regression, Linear|||||||0.841
71117921|NCT00191724|141740763|SUPERIORITY_OR_OTHER|||||||0.797||95.0||||P-value for Fatigue 90 Day Follow-Up.|Regression, Linear|||||||0.797
71117922|NCT00191724|141740763|SUPERIORITY_OR_OTHER|||||||0.963||95.0||||P-value for Mastery 90 Day Follow-Up.|Regression, Linear|||||||0.963
71117923|NCT00191724|141740763|SUPERIORITY_OR_OTHER|||||||0.149||95.0||||P-value for Dyspnea 90 Day Follow-Up.|Regression, Linear|||||||0.149
71117924|NCT00191724|141740763|SUPERIORITY_OR_OTHER|||||||0.141||95.0||||P-value for Emotional 90 Day Follow-Up.|Regression, Linear|||||||0.141
71117925|NCT00191724|141740763|SUPERIORITY_OR_OTHER|||||||0.774||95.0||||P-value for Fatigue 90 Day Follow-Up.|Regression, Linear|||||||0.774
71117926|NCT00191724|141740763|SUPERIORITY_OR_OTHER|||||||0.394||95.0||||P-value for Mastery 90 Day Follow-Up.|Regression, Linear|||||||0.394
71117927|NCT02301546|141740765|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
71117928|NCT02447250|141740769|OTHER|||||||0.14|||||||Chi-squared|||comparison of mean birth weights between responders and non-responders||||0.14
71117929|NCT02447250|141740770|OTHER|||||||0.16|||||||Chi-squared|||||||0.16
71117930|NCT02447250|141740771|OTHER|||||||1|||||||Fisher Exact|||||||1.0
71117931|NCT02447250|141740773|OTHER|||||||1|||||||Chi-squared|||||||1.0
71117932|NCT02447250|141740774|OTHER|||||||0.5|||||||Fisher Exact|||||||0.50
71117933|NCT01885208|141740775|NON_INFERIORITY|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 1.0 mg and exenatide ER 2.0 mg was below the pre-specified non-inferiority margin (0.3 %).|Treatment difference|-0.62|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.44|||Mixed Models Analysis|||The post-baseline responses were analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.||-0.44|-0.8|< 0.0001
71117934|NCT01885208|141740775|SUPERIORITY|Superiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 1.0 mg and exenatide ER 2.0 mg was below the pre-specified superiority margin (0 %).|Treatment difference|-0.62|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.44|||Mixed Models Analysis|||The post-baseline responses were analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.||-0.44|-0.8|< 0.0001
71117935|NCT01709422|141740781|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.2||||0.05||95.0|||||Chi-squared|||||||0.05
71117936|NCT01709422|141740782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.0||||0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.05
71117937|NCT00396006|141740784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0195|||||||Wilcoxon signed rank test|||||||0.0195
70942643|NCT02849509|141385313|OTHER|||||||0.0423||||||p-value of paired t-test compared between matched Pradaxa® and VKA patients|Paired t-test|||Convenience dimension score of PACT-Q2 for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.0423
71117938|NCT00396006|141740788|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||paired t-tests|||||||<0.0001
71117939|NCT00396006|141740789|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||paired t-tests|||||||<0.0001
71117940|NCT00396006|141740791|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1875|||||||Wilcoxon signed rank test|||||||0.1875
71117941|NCT00396006|141740792|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4375|||||||Wilcoxon signed rank|||||||0.4375
70854252|NCT00594425|141196884|SUPERIORITY_OR_OTHER||Least squares mean|-0.33||||0.9151|TWO_SIDED|95.0|-6.53|5.86||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model including center and baseline lesion count as a covariates. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||5.86|-6.53|0.9151
70854253|NCT00594425|141196884|SUPERIORITY_OR_OTHER||Least squares mean|-1.18||||0.7233|TWO_SIDED|95.0|-7.81|5.45||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model including center and baseline lesion count as a covariates. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||5.45|-7.81|0.7233
70854254|NCT01122264|141196886|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.66|||<|0.001|TWO_SIDED|97.3|0.51|0.85||P-value: Tadalafil Once a Day versus Sildenafil Citrate On Demand treatment groups. Cox's proportional hazards model with factors for randomized treatment group, baseline International Index of Erectile Function-Erectile Function score, and country.|Regression, Cox|||||0.85|0.51|<0.001
70854255|NCT01122264|141196886|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.49|||<|0.001|TWO_SIDED|97.3|0.37|0.65||P-value: Tadalafil On Demand versus Sildenafil Citrate On Demand treatment groups. Cox's proportional hazards model with factors for randomized treatment group, baseline International Index of Erectile Function-Erectile Function score, and country.|Regression, Cox|||||0.65|0.37|<0.001
71117942|NCT01972308|141740796|SUPERIORITY||Group differences in expected 12 month c|-0.31|||||TWO_SIDED|95.0|-0.64|0.04||||||||0.04|-0.64|
71117943|NCT01972308|141740797|SUPERIORITY||Group differences in expected 12 month c|-0.66|||||TWO_SIDED|95.0|-1.38|-0.01||||||||-0.01|-1.38|
71117944|NCT01972308|141740798|SUPERIORITY||Group differences in expected 12 month c|0.06|||||TWO_SIDED|95.0|-0.33|0.43||||||||0.43|-0.33|
71117945|NCT01972308|141740799|SUPERIORITY||Group differences in expected 12 month c|0.02|||||TWO_SIDED|95.0|-0.42|0.48||||||||0.48|-0.42|
71117946|NCT01972308|141740800|SUPERIORITY||Group differences in expected 12 month c|0.04|||||TWO_SIDED|95.0|-0.1|0.19||||||||0.19|-0.10|
71117947|NCT01972308|141740801|SUPERIORITY||Group differences in expected 12 month c|0.12|||||TWO_SIDED|95.0|-0.24|0.6||||||||0.60|-0.24|
71117948|NCT02851797|141740822|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in 4SC at Month 18 with baseline values for: 4SC, time to rise from floor, time to run/walk 10 metres, distance walked in 6 minutes and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|generalised least square mean ratio|0.86|||=|0.0345|TWO_SIDED|95.0|0.745|0.989||LS Means, CIs, and p-values are obtained from ANCOVA model on change from baseline in 4SC at Month 18 with baseline values for: the above mentioned parameters as covariates, with steroid use and treatment group as independent classificat factors.|ANCOVA||LS Means, CIs, and p-values are obtained from ANCOVA model on change from baseline in 4SC at Month 18 with baseline values for: the above mentioned parameters as covariates, with steroid use and treatment group as independent classificat factors.|Log transformation applied||0.989|0.745|=0.0345
70854256|NCT01122264|141196886|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.32||||0.033|TWO_SIDED|95.0|1.02|1.71||P-value: Tadalafil On Demand versus Tadalafil Once a Day treatment groups using Cox's proportional hazards model with factors for randomized treatment group, baseline International Index of Erectile Function-Erectile Function score, and country.|Regression, Cox|||||1.71|1.02|0.033
70854257|NCT02558829|141196931|OTHER|Positive percent agreement \[%\] = 100% x A/(A+C). A= MAC outcome positive and ITT outcome positive; C = MAC outcome negative and ITT positive|CI (Clopper Pearson): positive agreement|74.32|||||TWO_SIDED|95.0|62.84|83.78||||||The estimated percentages of the agreements and the two-sided 95% confidence interval (or one-sided 97.5% confidence interval) of the percent agreement based on Clopper-Pearson are presented. The performance of the MAC (cut-off point 2.8 ng/mL) was considered to be acceptable if the lower bound of the two-sided 95% CI (or lower bound of the one-sided 97.5% CI) was 75% or higher for 'percent negative agreement', and 70% or higher for the 'percent positive agreement'.||83.78|62.84|
70854258|NCT02558829|141196931|OTHER|Negative percent agreement \[%\] = 100% x D/(B+D). D = MAC outcome negative and ITT outcome negative; B = MAC outcome positive and ITT outcome negative|CI (Clopper Pearson): negative agreement|93.94|||||TWO_SIDED|95.0|85.2|98.32||||||Please refer to Statistical Analysis 1.||98.32|85.20|
70854259|NCT02558829|141196932|OTHER|The secondary diagnostic accuracy measure was 'percent overall agreement'.|overall agreement|83.57|||||TWO_SIDED|95.0|76.38|89.29||||||This variable was analyzed using the same methodology described for the analyses for the primary efficacy variables. in the below, the results for Step 1 (peak GH level among all post baseline samples) are presented.||89.29|76.38|
70854260|NCT02558829|141196934|OTHER||Mean Difference (Final Values)|-2.9|STANDARD_DEVIATION|6.38|||TWO_SIDED|||||||||"Pre/post dose comparison of ECGs was done for both GHSTs. During the GHSTs, ECGs were measured at pre-dose (up to 15 min before) and 60 minutes post-dose. Furthermore, ECGs were measured at screening and at End-of-Study (EOS) Visit.~Calculations were done from two time points: baseline and 60 min post-dose. Baseline is either the screening or pre-dose value."||||
70854261|NCT02558829|141196934|OTHER|Please refer to Statistical Analysis 1 for this secondary outcome measure.|Mean Difference (Final Values)|1.8|STANDARD_DEVIATION|8.15|||TWO_SIDED|||||||||||||
71117949|NCT02851797|141740823|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in time to rise from the Floor at Month 18 with baseline values for: 4SC, time to rise from floor, time to run/walk 10 m, distance walked in 6 minutes and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|difference in least square means|-3.28|||=|0.3044|TWO_SIDED|95.0|-9.573|3.018||See comment above|ANCOVA||See comment above|||3.018|-9.573|=0.3044
71117950|NCT02851797|141740824|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in distance walked at the end of the 6-minute walking test (6MWT) at Month 18 with baseline values for: 4SC, time to rise from floor, time to run/walk 10 metres, distance walked in 6 minutes and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|Difference in least square means|9.96|||=|0.3723|TWO_SIDED|95.0|-12.071|31.983||See comment above|ANCOVA|LS means, CIs, p-values were obtained from analysis of covariance model on change from baseline in distance walked at the end of the 6MWT at Month18.|See comment above|||31.983|-12.071|=0.3723
71117951|NCT02851797|141740825|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in total NSAA score at Month 18 with baseline values for: total NSAA score, 4SC, time to rise from floor, time to run/walk 10 metres, distance walked in 6 minutes and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|Difference in least square means|1.91|||=|0.0209|TWO_SIDED|95.0|0.295|3.533||Same comment as above|ANCOVA||Same comment as above.|||3.533|0.295|=0.0209
71117952|NCT02851797|141740826|SUPERIORITY|Estimated cumulative failures, ratio of cumulative failures, CIs, and p-values are obtained from a negative binomial regression on the subject cumulative number of failures across all post-baseline visits. Total failed items at baseline, baseline values for: 4SC, time to rise from floor, time to run/walk 10 metres, distance walked in 6 minutes and re-derived age at first dose were included as independent covariates, with treatment group and steroid use included as indep classification factors.|Ratio of cumulative failures|0.61|||=|0.0202|TWO_SIDED|95.0|0.408|0.927||same comment as above|negative binomial regression model|Estimated cumulative failures, their ratio were obtained from a negative binomial regression on the cumulative N of failures across all visits.|"A lower ratio indicates a greater reduction in cumulative loss of function across 18 months for givinostat compared with placebo.~See also comment above."|||0.927|0.408|=0.0202
71117953|NCT02851797|141740827|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in normalised muscle strength at Month 18 with baseline normalised muscle strength and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|Difference in least square means|0.19|||=|0.0902|TWO_SIDED|95.0|-0.03|0.401||same comment as above|ANCOVA||same comment as above|Overall knee extension||0.401|-0.030|=0.0902
71117954|NCT02851797|141740827|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in normalised muscle strength at Month 18 with baseline normalised muscle strength and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|Difference in least square means|0.09|||=|0.1818|TWO_SIDED|95.0|-0.041|0.213||same comment as above|ANCOVA||same comment as above|Overall elbow flexion||0.213|-0.041|=0.1818
71117955|NCT02851797|141740828|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in VL MFF at Month 18 with baseline VL MFF and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|Difference in least square means|-2.92|||=|0.0354|TWO_SIDED|95.0|-5.641|-0.204||Same comment as above|ANCOVA||Same comment as above|||-0.204|-5.641|=0.0354
71117956|NCT04295681|141740854|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.0006|TWO_SIDED|95.0|0.47|1.7|||t-test, 2 sided||"Estimated value is calculated as MMH-MAP minus Placebo difference in mean MoCA scores changes."|Mean changes of MoCA scores (90th day of treatment minus baseline) were compared.||1.70|0.47|0.0006
70942644|NCT02849509|141385313|OTHER|||||||0.2226||||||p-value of paired t-test compared between matched Pradaxa® and VKA patients|Paired t-test|||Satisfaction dimension score of PACT-Q2 for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.2226
70854262|NCT02558829|141196935|OTHER|Sensitivity is the probability that the test result is positive given the subject has the disease (for the purpose of this analysis, all group A subjects were assumed to have AGHD, but none of the group D subjects). Sensitivity (SS) was estimated by: SS = TP/(TP+FN). TP=True AGHD positive subject; FN=False AGHD negative subject.|CI (Clopper Pearson)|0.87|||||TWO_SIDED|95.0|0.72|0.96||||||Sensitivity was estimated for the MAC at the pre-defined cut-off point GH: 2.8 ng/mL.||0.96|0.72|
70942645|NCT02849509|141385314|OTHER|||||||0.0287||||||p-value of paired t-test compared between matched Pradaxa® and VKA patients|Paired t-test|||Convenience dimension score of PACT-Q2 for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.0287
70942646|NCT02849509|141385314|OTHER|||||||0.03||||||p-value of paired t-test compared between matched Pradaxa® and VKA patients|Paired t-test|||Satisfaction dimension score of PACT-Q2 for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.0300
70942647|NCT02849509|141385320|OTHER|||||||0.1234||||||p-value of paired t-test compared between second assessment (Visit 2) and last assessment (Visit 3)|Paired t-test|||Convenience dimension score of PACT-Q2 for patients in Cohort A, were compared between second assessment (Visit 2) and last assessment (Visit 3). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.1234
71117957|NCT04295681|141740855|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.67|TWO_SIDED|95.0|-0.58|0.37|||t-test, 2 sided||"Estimated value is calculated as MMH-MAP minus Placebo difference in mean MoCA scores changes."|Mean changes of NIHSS scores (baseline minus 12th day of treatment) were compared.||0.37|-0.58|0.67
71117958|NCT04295681|141740855|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.94|TWO_SIDED|95.0|-0.47|0.5|||t-test, 2 sided||"Estimated value is calculated as MMH-MAP minus Placebo difference in mean MoCA scores changes."|Mean changes of NIHSS scores (baseline minus 90th day of treatment) were compared.||0.50|-0.47|0.94
71117959|NCT04295681|141740856|SUPERIORITY|||||||0.89|||||||Fisher Exact|||Test for comparison percentage of patients with no significant disabilities after 90 days of treatment .||||0.89
71117960|NCT04295681|141740857|SUPERIORITY|||||||0.067|||||||Wilcoxon (Mann-Whitney)|||Therapeutic effect score comparison on 90th day of treatment.||||0.067
71117961|NCT04295681|141740857|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Side effects score comparison on 90th day of treatment.||||0.81
71117962|NCT04295681|141740857|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Efficacy index score comparison on 90th day of treatment.||||0.17
71117963|NCT04295681|141740858|SUPERIORITY|||||||0.656|||||||Fisher Exact|||The percentage of participants having at least one adverse event were compared.||||0.656
71117964|NCT04295681|141740859|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
71117965|NCT04295681|141740861|SUPERIORITY|||||||0.96|||||||ANOVA|"P-value for interaction between factors Treatment and Visit is demonstrated."||"Analysis of variance (ANOVA) for repeated measures has been used. Factors are Treatment, Visit and interaction Treatment-Visit. Significance of interaction as a factor representing difference in outcome value dynamics has been tested."||||0.96
71117966|NCT04295681|141740862|SUPERIORITY|||||||0.96|||||||ANOVA|"P-value for interaction between factors Treatment and Visit is demonstrated."||"Analysis of variance (ANOVA) for repeated measures has been used. Factors are Treatment, Visit and interaction Treatment-Visit. Significance of interaction as a factor representing difference in outcome value dynamics has been tested."||||0.96
71117967|NCT04295681|141740863|SUPERIORITY|||||||0.438|||||||ANOVA|"P-value for interaction between factors Treatment and Visit is demonstrated."||"Systolic blood pressure. Analysis of varience (ANOVA) for repeated measures has been used. Factors are Treatment, Visit and interaction Treatment-Visit. Significance of interaction as a factor representing difference in outcome value dynamics has been tested."||||0.438
71117968|NCT04295681|141740863|SUPERIORITY|||||||0.56|||||||ANOVA|"P-value for interaction between factors Treatment and Visit is demonstrated."||"Diastolic blood pressure. Analysis of variance (ANOVA) for repeated measures has been used. Factors are Treatment, Visit and interaction Treatment-Visit. Significance of interaction as a factor representing difference in outcome value dynamics has been tested."||||0.56
71117969|NCT04295681|141740864|SUPERIORITY|||||||0.72|||||||Fisher Exact|||Comparison at the baseline.||||0.72
71117970|NCT04295681|141740864|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison on 90th day of treatment.||||1
71117971|NCT04295681|141740865|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
71117972|NCT00803400|141740866|OTHER||Mean Difference (Final Values)|1.0|||<|0.001|ONE_SIDED||||||t-test, 1 sided|||A p-value less than 0.05 (≤ 0.05) is statistically significant. It indicates strong evidence against the null hypothesis, as there is less than a 5% probability the null is correct (and the results are random)||||<0.001
71117973|NCT02135029|141740883|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-54.5|STANDARD_ERROR_OF_MEAN|2.82|<|0.001|TWO_SIDED|95.0|-60.1|-49.0|||MMRM|Mixed Model Repeated Measures (MMRM)|LS-mean differences,associated 95% confidence interval (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit,treatment group\*visit interaction,baseline value, baseline value\*visit\*group interaction, country.|||-49.0|-60.1|<0.001
71117974|NCT02135029|141740884|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.4|STANDARD_ERROR_OF_MEAN|2.13|<|0.001|TWO_SIDED|95.0|-42.6|-34.2|||MMRM||LS-mean differences, associated 95% CI, and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-34.2|-42.6|<0.001
71117975|NCT02135029|141740884|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.0|STANDARD_ERROR_OF_MEAN|2.47|||TWO_SIDED|95.0|-35.9|-26.2|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-26.2|-35.9|
71117976|NCT02135029|141740885|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.5|STANDARD_ERROR_OF_MEAN|2.72|<|0.001|TWO_SIDED|95.0|-51.9|-41.1|||MMRM||LS-mean differences, associated 95% CI, and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-41.1|-51.9|<0.001
71117977|NCT02135029|141740885|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.3|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-45.4|-33.2|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-33.2|-45.4|
71117978|NCT02135029|141740886|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.2|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|-56.3|-46.0|||MMRM||LS-mean differences, associated 95% CI, and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-46.0|-56.3|<0.001
71117979|NCT02135029|141740886|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.8|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|-47.7|-35.8|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-35.8|-47.7|
71117980|NCT02135029|141740887|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.3|STANDARD_ERROR_OF_MEAN|6.32|<|0.001|TWO_SIDED|95.0|-35.7|-10.8|||MMRM||LS-mean differences, associated 95% CI, and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-10.8|-35.7|<0.001
71117981|NCT02135029|141740887|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.4|STANDARD_ERROR_OF_MEAN|6.21|||TWO_SIDED|95.0|-29.6|-5.1|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-5.1|-29.6|
71117982|NCT02135029|141740888|SUPERIORITY_OR_OTHER||LS Mean Difference|12.4|STANDARD_ERROR_OF_MEAN|2.34|<|0.001|TWO_SIDED|95.0|7.8|17.0|||MMRM||LS-mean differences, associated 95% CI, and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||17.0|7.8|<0.001
71117983|NCT02135029|141740888|SUPERIORITY_OR_OTHER||LS Mean Difference|11.5|STANDARD_ERROR_OF_MEAN|2.47|||TWO_SIDED|95.0|6.7|16.4|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||16.4|6.7|
71117984|NCT02135029|141740889|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.8|STANDARD_ERROR_OF_MEAN|3.33|||TWO_SIDED|95.0|-51.3|-38.2|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-38.2|-51.3|
71117985|NCT02135029|141740890|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.3|STANDARD_ERROR_OF_MEAN|4.67|||TWO_SIDED|95.0|-23.5|-5.2|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-5.2|-23.5|
71117986|NCT02135029|141740890|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.7|STANDARD_ERROR_OF_MEAN|5.14|||TWO_SIDED|95.0|-19.8|0.4|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||0.4|-19.8|
71117987|NCT02135029|141740891|SUPERIORITY_OR_OTHER||LS Mean Difference|6.1|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|2.2|10.1|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||10.1|2.2|
71117988|NCT02135029|141740891|SUPERIORITY_OR_OTHER||LS Mean Difference|5.6|STANDARD_ERROR_OF_MEAN|2.09|||TWO_SIDED|95.0|1.5|9.7|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||9.7|1.5|
71117989|NCT02135029|141740892|SUPERIORITY_OR_OTHER||LS Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|2.02|||TWO_SIDED|95.0|0.8|8.7|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||8.7|0.8|
71117990|NCT02135029|141740892|SUPERIORITY_OR_OTHER||LS Mean Difference|6.5|STANDARD_ERROR_OF_MEAN|2.07|||TWO_SIDED|95.0|2.4|10.5|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||10.5|2.4|
71117991|NCT02135029|141740893|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.3|STANDARD_ERROR_OF_MEAN|4.67|||TWO_SIDED|95.0|-23.5|-5.2|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-5.2|-23.5|
71117992|NCT02135029|141740893|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.7|STANDARD_ERROR_OF_MEAN|5.14|||TWO_SIDED|95.0|-19.8|0.4|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||0.4|-19.8|
70942648|NCT02849509|141385320|OTHER|||||||0.974||||||p-value of paired t-test compared between second assessment (Visit 2) and last assessment (Visit 3)|Paired t-test|||Satisfaction dimension score of PACT-Q2 for patients in Cohort A, were compared between second assessment (Visit 2) and last assessment (Visit 3). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.9740
71079849|NCT01778751|141666963|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1||||0.397|TWO_SIDED|95.0|-1.4|3.6|||Mixed Models Analysis|||Comparison at 6 months. Scale is 0-27 where a lower score is a better outcome, values were dichotomized to indicate whether or not the patient was depressed.||3.6|-1.4|0.397
71079850|NCT00856843|141666980|SUPERIORITY_OR_OTHER||Difference in success rates|8.8||||0.038|TWO_SIDED|95.0|0.9|16.8|||Chi-squared|||||16.8|0.9|0.038
71079851|NCT00856843|141666981|SUPERIORITY_OR_OTHER|||||||0.01|||||||Chi-squared|||||||0.010
71079852|NCT00856843|141666982|SUPERIORITY_OR_OTHER|||||||0.02|||||||Chi-squared|||||||0.020
71079853|NCT00856843|141666983|SUPERIORITY_OR_OTHER|||||||0.644|||||||Chi-squared|||||||0.644
71079854|NCT00856843|141666984|SUPERIORITY_OR_OTHER|||||||0.763|||||||Chi-squared|||||||0.763
71079855|NCT00856843|141666985|SUPERIORITY_OR_OTHER|||||||0.173|||||||Chi-squared|||||||0.173
71079856|NCT00856843|141666986|SUPERIORITY_OR_OTHER|||||||0.004|||||||Chi-squared|||||||0.004
71079857|NCT00856843|141666987|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
71079858|NCT00856843|141666988|SUPERIORITY_OR_OTHER|||||||0.005|||||||Chi-squared|||||||0.005
70942649|NCT02256488|141385322|NON_INFERIORITY_OR_EQUIVALENCE|"The lot-to-lot consistency was claimed if the 2-sided 95% CIs of all the three pairwise comparisons was within the equivalence ranges, that is:~(μlot A - μlot B) \> -0.176 and (μlot A - μlot B) \< 0.176 and (μlot A - μlot C) \> -0.176 and (μlot A - μlot C) \< 0.176 and (μlot B - μlot C) \> -0.176 and (μlot B - μlot C) \< 0.176"|Ratio of GMTs|0.9|||||TWO_SIDED|95.0|0.667|1.5|||ANCOVA|||To demonstrate immunologic equivalence of three consecutive TIVc production lots as evaluated by HI antibody responses after vaccination for all 3 influenza strains at day 22.||1.5|0.667|
71079859|NCT00856843|141666989|SUPERIORITY_OR_OTHER|||||||0.013|||||||Chi-squared|||||||0.013
71079860|NCT00856843|141666990|SUPERIORITY_OR_OTHER|||||||0.283|||||||Chi-squared|||||||0.283
71079861|NCT03078127|141666994|SUPERIORITY|||||||0.615||||||ANOVA was performed (with multiple comparisons to compare each intervention to baseline) to assess for difference in MCC with each ACT. The a priori threshold for statistical significance was set to 0.05|ANOVA|||No comparable preliminary data exists on mucociliary clearance (MCC) in response to airway clearance therapy methods (ACTs) for a power calculation. However, prior studies of medication effect on MCC gave a baseline mean change of Ave270 clr of 27.7% (std dev of 15.1%). Thus, the investigators estimated a mean change of 20% for effective ACT with the same estimate for variability (Std Dev of 15.1%). Using a paired 2-tailed test to compare means, 7 subjects were estimated to be needed.||||0.615
71079862|NCT03078127|141666995|SUPERIORITY|||||||0.696||||||ANOVA was performed (with multiple comparisons to compare each intervention to baseline) to assess for difference in MCC with each ACT. The a priori threshold for significance was \< 0.05.|ANOVA|||||||0.696
71079863|NCT03078127|141666997|SUPERIORITY|||||||0.001||||||The a priori threshold of statistical significance was p = 0.05|t-test, 2 sided|||The investigators compared FENO before and after ACT in a pooled manner (i.e., grouping each of the comparisons together), as the study was not powered for FENO comparisons within each ACT type.||||0.001
71079864|NCT03078127|141666997|OTHER|A linear regression was performed between change in FENO and Ave90Clr||||||0.692||||||The a priori threshold for statistical significance (i.e., slope different than zero) between MCC and FENO was 0.05|Regression, Linear|||if the difference between pre and post-ACT FENO was significant (defined as p\<0.05), it was investigated whether change in FENO correlated with MCC (as represented by Ave90Clr)||||0.692
71079865|NCT03078127|141666998|SUPERIORITY|||||||0.146||||||Non-parametric test used due to lack of data normality. The a prior threshold for statistical significance was \< 0.05|Wilcoxon signed-rank test|||The study was not designed or powered to assess for inter-group differences between the types of ACT, and for analytical purposes, these were pooled, with the analysis being a paired comparison within subjects to pre- to post-ACT.||||0.146
71079866|NCT03078127|141666999|SUPERIORITY|||||||0.041||||||Non-parametric test used due to lack of data normality. The a priori threshold for statistical significance was \< 0.05|Wilcoxon signed-rank test|||The study was not designed or powered to assess for inter-group differences between the types of ACT, and for analytical purposes, these were pooled, with the analysis being a paired comparison within subjects to pre- to post-ACT.||||0.041
71079867|NCT03078127|141666999|OTHER|A linear regression was performed between change in pre and post-ACT adenosine (purine) in EBC and Ave90Clr||||||0.047||||||The a priori threshold of statistical significance was p = 0.05|Regression, Linear|||If the difference between pre and post-ACT adenosine (purine) in EBC was significant (defined as p\<0.05), the correlation between change in adenosine concentration and MCC (as represented by Ave90Clr) was investigated.||||0.047
71079868|NCT03078127|141667000|SUPERIORITY|||||||0.07||||||Non-parametric test used due to lack of data normality. The a priori threshold for statistical significance was \< 0.05|Wilcoxon signed-rank test|||The study was not designed or powered to assess for inter-group differences between the types of ACT, and for analytical purposes, these were pooled, with the analysis being a paired comparison within subjects to pre- to post-ACT.||||0.070
71079869|NCT00076258|141667011|SUPERIORITY_OR_OTHER_LEGACY||Remission rate|29.5|||<|0.05|TWO_SIDED||||||Generalized Linear Mixed Model|Both unadjusted and adjusted rates (for significant covariates) were reported||||||<0.05
71079870|NCT00076258|141667011|SUPERIORITY_OR_OTHER_LEGACY||Remission Rate|28.3|||<|0.05|TWO_SIDED||||||Generalized Linear Mixed Model|||For the covariate adjusted GLMM the remission rates were 15.5 for the LD and 28.3 for the PHD with a p \< 0.06 and the NNT of 7.8 for the PHD versus the LD.||||<0.05
71079871|NCT00398216|141667016|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Fisher Exact|||||||0.003
71079872|NCT00398216|141667016|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
71079873|NCT00398216|141667016|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
71079874|NCT00398216|141667016|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
71079875|NCT00398216|141667019|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Fisher Exact|||||||.250
71079876|NCT00398216|141667019|SUPERIORITY_OR_OTHER|||||||0.122|TWO_SIDED||||||Fisher Exact|||||||.122
70942650|NCT02256488|141385322|NON_INFERIORITY_OR_EQUIVALENCE|"The lot-to-lot consistency was claimed if the 2-sided 95% CIs of all the three pairwise comparisons was within the equivalence ranges, that is:~(μlot A - μlot B) \> -0.176 and (μlot A - μlot B) \< 0.176 and (μlot A - μlot C) \> -0.176 and (μlot A - μlot C) \< 0.176 and (μlot B - μlot C) \> -0.176 and (μlot B - μlot C) \< 0.176"|Ratio of GMTs|1.02|||||TWO_SIDED|95.0|0.667|1.5|||ANCOVA|||To demonstrate immunologic equivalence of three consecutive TIVc production lots as evaluated by HI antibody responses after vaccination for for all 3 influenza strains at day 22||1.5|0.667|
70942651|NCT02256488|141385322|NON_INFERIORITY_OR_EQUIVALENCE|"The lot-to-lot consistency was claimed if the 2-sided 95% CIs of all the three pairwise comparisons was within the equivalence ranges, that is:~(μlot A - μlot B) \> -0.176 and (μlot A - μlot B) \< 0.176 and (μlot A - μlot C) \> -0.176 and (μlot A - μlot C) \< 0.176 and (μlot B - μlot C) \> -0.176 and (μlot B - μlot C) \< 0.176"|Ratio of GMTs|1.12|||||TWO_SIDED|95.0|0.667|1.5|||ANCOVA|||To demonstrate immunologic equivalence of three consecutive TIVc production lots as evaluated by HI antibody responses after vaccination for all 3 influenza strains at day 22||1.5|0.667|
70942652|NCT02864147|141385330|SUPERIORITY|||||||0.043||||||Control is used as the referent using one-sided Fisher's exact tests with a multiple comparison-adjusted p\<0.025 significance level.|Fisher Exact|||||||0.043
71079877|NCT00398216|141667019|SUPERIORITY_OR_OTHER|||||||0.124|TWO_SIDED||||||Fisher Exact|||||||.124
71079878|NCT00398216|141667019|SUPERIORITY_OR_OTHER|||||||0.123|TWO_SIDED||||||Fisher Exact|||||||.123
70942653|NCT02864147|141385330|SUPERIORITY|||||||0.384||||||Control is used as the referent using one-sided Fisher's exact tests with a multiple comparison-adjusted p\<0.025 significance level.|Fisher Exact|||||||0.384
70942654|NCT02864147|141385331|SUPERIORITY|||||||0.177||||||Control is used as the referent using one-sided Fisher's exact tests with a multiple comparison-adjusted p\<0.025 significance level.|Fisher Exact|||||||0.177
70942655|NCT02864147|141385331|SUPERIORITY|||||||0.592||||||Control is used as the referent using one-sided Fisher's exact tests with a multiple comparison-adjusted p\<0.025 significance level.|Fisher Exact|||||||0.592
71079879|NCT01048944|141667021|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values are adjusted for multiple comparisons except for specific a priori directional predictions.|Mixed Models Analysis|||Mixed-model repeated measures multivariate analyses of variance assessed Treatment x Day of abstinence (days 3, 24, 45, and 66) based on changes from pre-quit baseline to values of the four post-quit time points (days 3, 24, 45, and 66).||||<0.05
70942656|NCT02963922|141385579|SUPERIORITY|The treatment policy estimand evaluated the treatment effect (liraglutide 3.0 mg vs placebo) at week 56 for all randomised participants regardless of premature discontinuation of trial product.|Treatment difference|-4.32|STANDARD_ERROR_OF_MEAN|0.59|<|0.0001|TWO_SIDED|95.0|-5.48|-3.16|||ANCOVA||Liraglutide 3.0 mg - placebo|Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, body mass index (BMI) groups and sex as factors and baseline body weight as covariate.||-3.16|-5.48|< .0001
70942657|NCT02963922|141385579|SUPERIORITY|The hypothetical estimand evaluated the treatment effect (liraglutide 3.0 mg vs placebo) for all randomised participants assuming that all participants remained on trial product (on-treatment principle).|Treatment difference|-5.1|STANDARD_ERROR_OF_MEAN|0.61|<|0.0001|TWO_SIDED|95.0|-6.3|-3.91|||MMRM||Liraglutide 3.0 mg - placebo|Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups and sex as factors and baseline body weight as covariate, all nested within visit.||-3.91|-6.30|< .0001
70942658|NCT02963922|141385580|SUPERIORITY||Odds Ratio (OR)|3.41|||<|0.0001|TWO_SIDED|95.0|2.19|5.31|||Regression, Logistic||Liraglutide 3.0 mg/Placebo|Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using a logistic regression model with treatment, BMI groups and sex as factors and baseline body weight as covariate.||5.31|2.19|<.0001
70942659|NCT02963922|141385580|SUPERIORITY||Odds Ratio (OR)|4.73|||<|0.0001|TWO_SIDED|95.0|3.04|7.36|||Mixed model for repeated measurements||Liraglutide 3.0 mg/Placebo|Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups and sex as factors and baseline body weight as covariate, all nested within visit. The MMRM was used to classify responders and analysed with a logistic regression with treatment as the only factor.||7.36|3.04|<.0001
71117993|NCT02135029|141740894|SUPERIORITY_OR_OTHER||LS Mean Difference|-93.8|STANDARD_ERROR_OF_MEAN|4.93|||TWO_SIDED|95.0|-103.5|-84.1|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-84.1|-103.5|
71117994|NCT02135029|141740895|SUPERIORITY_OR_OTHER||LS Mean Difference|-98.7|STANDARD_ERROR_OF_MEAN|5.67|||TWO_SIDED|95.0|-109.9|-87.5|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-87.5|-109.9|
71117995|NCT02135029|141740896|SUPERIORITY_OR_OTHER||LS Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|95.0|3.7|8.0|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||8.0|3.7|
71117996|NCT02135029|141740897|SUPERIORITY_OR_OTHER||LS Mean Difference|-103.6|STANDARD_ERROR_OF_MEAN|5.56|||TWO_SIDED|95.0|-114.6|-92.7|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-92.7|-114.6|
71117997|NCT02135029|141740899|SUPERIORITY_OR_OTHER||LS Mean Difference|-59.2|STANDARD_ERROR_OF_MEAN|3.46|||TWO_SIDED|95.0|-66.0|-52.4|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-52.4|-66.0|
71117998|NCT02135029|141740900|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|95.0|-8.7|-4.5|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-4.5|-8.7|
71117999|NCT02135029|141740901|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-2.7|-2.1|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-2.1|-2.7|
71118000|NCT02135029|141740901|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-2.4|-1.7|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-1.7|-2.4|
71118001|NCT02135029|141740902|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.5|-0.4|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-0.4|-0.5|
70942660|NCT03873038|141385666|OTHER|Geometric mean ratio (GMR) was derived using the geometric mean (GM) for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).|GMR|0.8|||||TWO_SIDED|90.0|0.54|1.18|||||GMR=GM ESRD/GM Healthy|||1.18|0.54|
70942661|NCT03873038|141385666|OTHER|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).|GMR|0.53|||||TWO_SIDED|90.0|0.37|0.76|||||GMR=GM ESRD/GM Healthy|||0.76|0.37|
70942662|NCT03873038|141385666|OTHER||GMR|0.82|||||TWO_SIDED|90.0|0.55|1.21|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.21|0.55|
71118002|NCT02135029|141740902|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.4|-0.3|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-0.3|-0.4|
70942663|NCT03873038|141385667|OTHER||GMR|1.41|||||TWO_SIDED|90.0|1.07|1.85|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.85|1.07|
70942664|NCT03873038|141385667|OTHER||GMR|0.86|||||TWO_SIDED|90.0|0.67|1.11|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001)||1.11|0.67|
70942665|NCT03873038|141385667|OTHER||GMR|0.82|||||TWO_SIDED|90.0|0.62|1.08|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.08|0.62|
70942666|NCT03873038|141385668|OTHER||GMR|1.11|||||TWO_SIDED|90.0|0.84|1.46|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.46|0.84|
70942667|NCT03873038|141385668|OTHER||GMR|0.68|||||TWO_SIDED|90.0|0.52|0.87|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||0.87|0.52|
70942668|NCT03873038|141385668|OTHER||GMR|0.78|||||TWO_SIDED|90.0|0.6|1.03|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.03|0.60|
70942669|NCT03873038|141385669|OTHER||GMR|1.5|||||TWO_SIDED|90.0|1.05|2.14|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||2.14|1.05|
70942670|NCT03873038|141385669|OTHER||GMR|0.91|||||TWO_SIDED|90.0|0.67|1.25|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.25|0.67|
70942671|NCT03873038|141385669|OTHER||GMR|0.86|||||TWO_SIDED|90.0|0.62|1.2|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.20|0.62|
70942672|NCT00595764|141385686|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|1.4||0.91|TWO_SIDED|95.0|||||ANOVA|||With an effect size of 0.46, a sample size of 140 will provide a power of \>.84 with p\<.05 to detect overall differences between the two treatments on the primary outcome measures.||||.91
70942673|NCT00595764|141385688|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|1.32||0.29|TWO_SIDED|95.0|||||t-test, 2 sided|||||||.29
70854263|NCT02558829|141196935|OTHER|"Specificity is the probability that the test result is negative given the subject does not have the disease.~Specificity (SP) was estimated by: SP = TN/(TN+FP). TN = True AGHD negative Subjects; FP = False AGHD positive subjects."|CI (Clopper Pearson)|0.96|||||TWO_SIDED|95.0|0.8|1.0||||||Specificity was estimated for the MAC at the pre-defined cut-off point GH: 2.8 ng/mL.||1.00|0.80|
70942674|NCT00595764|141385689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.029||0.58|TWO_SIDED|95.0|||||Mixed Models Analysis|Mixed Model Analysis to evaluate interaction of group by time.||||||.58
70942675|NCT00595764|141385690|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.38|STANDARD_ERROR_OF_MEAN|3.63||0.24|TWO_SIDED|95.0|||||Mixed Models Analysis|Mixed Model Analysis to evaluate interaction of group by time.||||||.24
70942676|NCT01332318|141385697|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.06||||95.0|0.08|0.42|||||An Analysis of Covariance (ANCOVA) model, including terms for treatment, pooled study site, visit, and treatment by visit interaction, was used to calculate the adjusted mean difference and confidence interval. Arm 2 minus Arm 1.|||0.42|0.08|
70942677|NCT01332318|141385697|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.06||||95.0|0.09|0.41|||||An Analysis of Covariance (ANCOVA) model, including terms for treatment, pooled study site, visit, and treatment by visit interaction, was used to calculate the adjusted mean difference and confidence interval. Arm 3 minus Arm 1.|||0.41|0.09|
70942678|NCT01332318|141385697|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.06||||95.0|0.09|0.42|||||An Analysis of Covariance (ANCOVA) model, including terms for treatment, pooled study site, visit, and treatment by visit interaction, was used to calculate the adjusted mean difference and confidence interval. Arm 4 minus Arm 1.|||0.42|0.09|
71079880|NCT04227405|141667029|SUPERIORITY||Slope|0.24|STANDARD_ERROR_OF_MEAN|0.23|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change between pre-test and post-test for the Positive Conflict Management subscale using multilevel modeling||||>.05
70942679|NCT01350388|141385733|SUPERIORITY_OR_OTHER|||||||0.84|||||||ANCOVA|||||||0.84
70942680|NCT01350388|141385734|SUPERIORITY_OR_OTHER|||||||0.73|||||||ANCOVA|||||||0.73
70942681|NCT01350388|141385735|SUPERIORITY_OR_OTHER|||||||0.23|||||||ANCOVA|||||||0.23
70942682|NCT01350388|141385736|SUPERIORITY_OR_OTHER|||||||0.88|||||||ANCOVA|||||||0.88
70942683|NCT01350388|141385737|SUPERIORITY_OR_OTHER|||||||0.13|||||||ANCOVA|||||||0.13
70942684|NCT01350388|141385738|SUPERIORITY_OR_OTHER|||||||0.35|||||||ANCOVA|||||||0.35
70942685|NCT02820298|141385741|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Ratio of Geometric LSM|131.41|||||TWO_SIDED|90.0|117.03|147.56|||||Ratio of Geometric LSM is the ratio of exponentiated mean difference of log-transformed PK parameter. Confidence interval from ANOVA (linear mixed-effects model) with treatment, period, and sequence as fixed effects, and subject as a random effect.|||147.56|117.03|
70942686|NCT02820298|141385743|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Ratio of Geometric LSM|110.29|||||TWO_SIDED|90.0|103.91|117.06|||||Ratio of Geometric LSM is the ratio of exponentiated mean difference of log-transformed PK parameter. Confidence interval from ANOVA (linear mixed-effects model) with treatment, period, and sequence as fixed effects, and subject as a random effect.|||117.06|103.91|
70942687|NCT02820298|141385744|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Ratio of Geometric LSM|108.34|||||TWO_SIDED|90.0|102.48|114.54|||||Ratio of Geometric LSM is the ratio of exponentiated mean difference of log-transformed PK parameter. Confidence interval from ANOVA (linear mixed-effects model) with treatment, period, and sequence as fixed effects, and subject as a random effect.|||114.54|102.48|
71079881|NCT04227405|141667029|SUPERIORITY||Slope|1.59|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change between pre-test and post-test for the Positive Conflict Management subscale using multilevel modeling||||<.001
70854264|NCT02558829|141196936|OTHER|Positive percent agreement \[%\] = 100% x A/(A+C). A= test outcome positive for MAC core study part and positive for MAC repeatability extension; C = test outcome positive for MAC core study part and negative for MAC repeatability extension.|CI (Clopper Pearson): positive agreement|88.89|||||TWO_SIDED|95.0|65.29|98.62||||||Please refer to Statistical Analysis 1 for this outcome.||98.62|65.29|
70854265|NCT02558829|141196936|OTHER|Negative percent agreement \[%\] = 100% x D/(B+D). D = test outcome negative for MAC core study part and negative for MAC repeatability extension; B = test outcome negative for MAC core study part and positive for MAC repeatability extension|CI (Clopper Pearson): negative agreement|100.0|||||TWO_SIDED|95.0|79.41|100.0||||||Amendment no 1 had been issued for selected sites in Europe to obtain exploratory data on the repeatability of the MAC in a subset of subjects that had completed the core study.||100.00|79.41|
70854266|NCT00097981|141196937|SUPERIORITY_OR_OTHER|||||||0.49|||||||Cochran-Mantel-Haenszel|Stratified by International Prognostic Index (IPI) stage 1,2 and 3||||||0.49
70854267|NCT00097981|141196938|SUPERIORITY_OR_OTHER|||||||0.42|||||||Cochran-Mantel-Haenszel|Stratified by International Prognostic Index (IPI) stage 1,2 and 3||||||0.42
70854268|NCT00097981|141196939|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||Log Rank|||||||0.42
70854269|NCT00097981|141196940|SUPERIORITY_OR_OTHER|||||||0.5162||95.0|||||Log Rank|||||||0.5162
70854270|NCT00097981|141196941|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.975||||0.93|TWO_SIDED|95.0|0.529|1.797|||Log Rank|Stratified log-rank test||||1.797|0.529|0.93
70854271|NCT01369329|141196983|SUPERIORITY_OR_OTHER|||||||0.002||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.002
70854272|NCT01369329|141196983|SUPERIORITY_OR_OTHER|||||||0.003||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.003
70854273|NCT01369329|141196984|SUPERIORITY_OR_OTHER|||||||0.003||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.003
70854274|NCT01369329|141196984|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||< 0.001
70854275|NCT01369329|141196985|SUPERIORITY_OR_OTHER|||||||0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.001
70854276|NCT01369329|141196985|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||< 0.001
70854277|NCT01369329|141196986|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||< 0.001
70854278|NCT01369329|141196986|SUPERIORITY_OR_OTHER|||||||0.002||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.002
70854279|NCT01369329|141196987|SUPERIORITY_OR_OTHER|||||||0.009||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.009
70854280|NCT01369329|141196987|SUPERIORITY_OR_OTHER|||||||0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.001
70942688|NCT01894256|141385746|SUPERIORITY_OR_OTHER||Geometric least squares means ratio|1.15|||||TWO_SIDED|90.0|1.04|1.27|||||GLS mean for Mild Renal Impairment group vs GLS mean for Normal Renal Function|Null hypothesis: There are no clinically significant differences in the PK of olaparib when administered to patients with moderate or mild renal impairment compared to patients with normal renal function.||1.27|1.04|
70854281|NCT02984943|141197029|OTHER|||||||0.1|||||||Skillings-Mack test|||||||0.10
70854282|NCT02984943|141197030|OTHER|||||||0.1|||||||Skillings-Mack test|||||||0.10
70854283|NCT02984943|141197031|OTHER|||||||0.02|||||||Skillings-Mack test|||||||0.02
70854284|NCT02984943|141197032|OTHER|||||||0.02|||||||Skillings-Mack test|||||||0.02
70854285|NCT02984943|141197033|OTHER|||||||0.004|||||||Skillings-Mack test|||||||0.004
70854286|NCT02984943|141197034|OTHER|||||||0.004|||||||Skillings-Mack test|||||||0.004
70854287|NCT02984943|141197035|OTHER|||||||0.2938|||||||Skillings-Mack test|||||||0.2938
70854288|NCT02984943|141197036|OTHER|||||||0.2938|||||||Skillings-Mack test|||||||0.2938
70854289|NCT02984943|141197037|OTHER|||||||0.0608|||||||Skillings-Mack test|||||||0.0608
70854290|NCT02984943|141197038|OTHER|||||||0.0608|||||||Skillings-Mack test|||||||0.0608
70854291|NCT02984943|141197039|OTHER|||||||0.1496|||||||Skillings-Mack test|||||||0.1496
70854292|NCT02984943|141197040|OTHER|||||||0.1496|||||||Skillings-Mack test|||||||0.1496
70854293|NCT02984943|141197041|OTHER|||||||0.36|||||||Skillings-Mack test|||||||0.36
70854294|NCT02984943|141197042|OTHER|||||||0.36|||||||Skillings-Mack test|||||||0.36
70854295|NCT02984943|141197043|OTHER|||||||0.0012|||||||Skillings-Mack test|||||||0.0012
70854296|NCT02984943|141197044|OTHER|||||||0.0012|||||||Skillings-Mack test|||||||0.0012
70854297|NCT02984943|141197045|OTHER|||||||0.9|||||||Skillings-Mack test|||||||0.90
70854298|NCT02984943|141197046|OTHER|||||||0.9|||||||Skillings-Mack test|||||||0.90
70854299|NCT02984943|141197047|OTHER|||||||0.0068|||||||Skillings-Mack test|||||||0.0068
70854300|NCT02984943|141197048|OTHER|||||||0.0068|||||||Skillings-Mack test|||||||0.0068
70854301|NCT02984943|141197049|OTHER|||||||0.0183|||||||Skillings-Mack test|||||||0.0183
70854302|NCT02984943|141197050|OTHER|||||||0.0183|||||||Skillings-Mack test|||||||0.0183
70854303|NCT02984943|141197051|OTHER|||||||0.08|||||||Skillings-Mack test|||||||0.08
70854304|NCT02984943|141197052|OTHER|||||||0.08|||||||Skillings-Mack test|||||||0.08
70854305|NCT02984943|141197053|OTHER||||||||||||||||||Descriptive statistics only were used|||
70854306|NCT02984943|141197054|OTHER||||||||||||||||||Descriptive statistics only were used|||
70854307|NCT02984943|141197055|OTHER||||||||||||||||||Descriptive statistics only were used|||
70854308|NCT02984943|141197056|OTHER||||||||||||||||||Descriptive statistics only were used|||
70854309|NCT02984943|141197057|OTHER||||||||||||||||||Descriptive statistics only were used|||
70854310|NCT02984943|141197058|OTHER||||||||||||||||||Descriptive statistics only were used|||
70854311|NCT02984943|141197059|OTHER||||||||||||||||||Descriptive statistics only were used|||
70854312|NCT02984943|141197061|OTHER||||||||||||||||||Descriptive statistics only were used|||
70854313|NCT02984943|141197062|OTHER||||||||||||||||||Descriptive statistics only were used|||
70854314|NCT02984943|141197063|OTHER||||||||||||||||||Descriptive statistics only were used|||
70854315|NCT02984943|141197065|OTHER||||||||||||||||||Descriptive statistics only were used|||
70854316|NCT02984943|141197066|OTHER||||||||||||||||||Descriptive statistics only were used|||
70854317|NCT02984943|141197067|OTHER||||||||||||||||||Descriptive statistics only were used|||
70854318|NCT02984943|141197068|OTHER||||||||||||||||||Descriptive statistics only were used|||
70854319|NCT02683746|141197099|NON_INFERIORITY|The primary hypothesis tested was that the liquid drug product would provide glycemic control non-inferior to the lyophilized drug product for a period of 26 weeks of treatment in participants with T2DM. Non-inferiority testing was performed at a one-sided alpha of 0.025 and non-inferiority margin of 0.4.|Mean Difference (Net)|0.06||||0.0002|TWO_SIDED|95.0|-0.13|0.24||P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model|||||0.24|-0.13|0.0002
70942689|NCT01894256|141385746|SUPERIORITY_OR_OTHER||Geometric least squares means ratio|1.26|||||TWO_SIDED|90.0|1.06|1.48|||||GLS mean for Moderate Renal Impairment group vs GLS mean for Normal Renal Function|Null hypothesis: There are no clinically significant differences in the PK of olaparib when administered to patients with moderate or mild renal impairment compared to patients with normal renal function.||1.48|1.06|
70854320|NCT02683746|141197107|OTHER||Mean Difference (Net)|-0.34|||||TWO_SIDED|95.0|-0.83|0.14||||||||0.14|-0.83|
70854321|NCT02683746|141197108|OTHER||Mean Difference (Net)|0.03|||<|0.0001|TWO_SIDED|95.0|-0.07|0.13||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 4 are presented.|||0.13|-0.07|<0.0001
70942690|NCT01894256|141385747|SUPERIORITY_OR_OTHER||Geometric least squares means ratio|1.24|||||TWO_SIDED|90.0|1.06|1.47|||||GLS mean for Mild Renal Impairment group vs GLS mean for Normal Renal Function|Null hypothesis: There are no clinically significant differences in the PK of olaparib when administered to patients with moderate or mild renal impairment compared to patients with normal renal function.||1.47|1.06|
70942691|NCT01894256|141385747|SUPERIORITY_OR_OTHER||Geometric least squares means ratio|1.44|||||TWO_SIDED|90.0|1.1|1.89|||||GLS mean for Moderate Renal Impairment group vs GLS mean for Normal Renal Function|Null hypothesis: There are no clinically significant differences in the PK of olaparib when administered to patients with moderate or mild renal impairment compared to patients with normal renal function.||1.89|1.10|
70942692|NCT01780584|141385758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.05|TWO_SIDED|95.0|1.0|3.0||Repeated Anova was used to determine whether there was difference of FT3 levels between groups|ANOVA|||Null hypothesis: no difference of free T3 (FT3) levels will be found between placebo, low dose and high dose group. We anticipated a difference of 2 pg/ml in FT3 with a standard deviation of 0.8 pg/ml between groups. For a statistical power of 80% to identify a treatment effect and at a level significance of 0.05 (2-sided).||3|1|<0.05
70942693|NCT01780584|141385760|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5.0||||0.31||95.0|3.0|10.0||Kruskal Wallis test was used to determine any difference of time of extubation between groups.|Kruskal-Wallis|||Null hypothesis: no difference of time to extubation between group. Statistical power 80% and level of significance 0.05||10|3|0.31
70942694|NCT01780584|141385761|SUPERIORITY_OR_OTHER||Median Difference (Net)|50.0||||0.4||95.0|40.0|60.0|||Kruskal-Wallis|||Null hypothesis: there is no difference of length of stay in Intensive Care Unit. Statistical power 80% and level of significance 0.05.||60|40|0.4
71118003|NCT05898672|141740917|OTHER||Ratio of adjusted geometric means|131.18|||||TWO_SIDED|90.0|115.89|148.48||||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant within sequence as a random effect. Ratio of adjusted geometric means of test to reference was reported; where test treatment is Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg and reference treatment is Rosuvastatin 10 mg. Ratio and associated 90% CIs were reported in percentage.||148.48|115.89|
71118004|NCT05898672|141740918|OTHER||Ratio of adjusted geometric means|212.44|||||TWO_SIDED|90.0|174.31|258.9||||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant within sequence as a random effect. Ratio of adjusted geometric means of test to reference was reported; where test treatment is Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg and reference treatment is Rosuvastatin 10 mg. Ratio and associated 90% CIs were reported in percentage.||258.90|174.31|
71118005|NCT01974206|141740943|OTHER||Common Odds Ratio|0.79||||0.307|TWO_SIDED|90.0|0.43|1.47||P-value (1-sided) of the Exact Cochran-Mantel-Haenszel method adjusted odds ratio stratified by randomization group.|Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel (CMH) estimate of the common odds ratio (ASP0113 vs placebo) stratified by randomization strata, and the 90% CIs of the CMH odds ratio stratified by randomization group.||1.47|0.43|0.307
71118006|NCT01974206|141740944|OTHER||Common Odds Ratio|0.99||||0.576|TWO_SIDED|90.0|0.46|2.15||P-value (1-sided) of the Exact Cochran-Mantel-Haenszel method adjusted odds ratio stratified by randomization group.|Cochran-Mantel-Haenszel|||The exact Cochran-Mantel-Haenszel (CMH) estimate of the common odds ratio (ASP0113 vs placebo) stratified by randomization group, and the 90% CI of the exact CMH odds ratio stratified by randomization group.||2.15|0.46|0.576
71118007|NCT01974206|141740945|OTHER||Common Odds Ratio|0.88||||0.408|TWO_SIDED|90.0|0.48|1.59||P-value (1-sided) of the Exact Cochran-Mantel-Haenszel method adjusted odds ratio stratified by randomization group.|Cochran-Mantel-Haenszel|||The exact Cochran-Mantel-Haenszel (CMH) estimate of the common odds ratio (ASP0113 vs placebo) stratified by randomization group, and the 90% CI of the exact CMH odds ratio stratified by randomization group.||1.59|0.48|0.408
71118008|NCT01974206|141740946|OTHER||Common Odds Ratio|0.88||||0.419|TWO_SIDED|90.0|0.48|1.61||P-value (1-sided) of the Exact Cochran-Mantel-Haenszel method adjusted odds ratio stratified by randomization group.|Cochran-Mantel-Haenszel|||The exact Cochran-Mantel-Haenszel (CMH) estimate of the common odds ratio (ASP0113 vs placebo) stratified by randomization group, and the 90% CI of the exact CMH odds ratio stratified by randomization group.||1.61|0.48|0.419
71118009|NCT01974206|141740947|OTHER|||||||0.5||||||P-value (1-sided) of the Exact Cochran-Mantel-Haenszel method adjusted odds ratio stratified by randomization group.|Cochran-Mantel-Haenszel|||Exact Cochran-Mantel-Haenszel estimate of the common odds ratio could not be calculated as 100% of ASP0113 group showed graft survival, and this leads to having a value of 0 for the denominator for the ratio thus odds ratio is not estimable. The 90% CI (2-sided) values for the odds ratio are 0.11 to NA, where NA is an infinity value.||||0.5
71118010|NCT05463744|141740966|NON_INFERIORITY|0.4% noninferiority margin (NIM)|LS Mean Difference|0.052|||||TWO_SIDED|95.0|-0.077|0.181|||ANCOVA|||||0.181|-0.077|
71118011|NCT05463744|141740967|SUPERIORITY||LS Mean Difference|0.052||||0.432|TWO_SIDED|95.0|-0.077|0.181|||ANCOVA|||||0.181|-0.077|0.432
71118012|NCT05463744|141740968|SUPERIORITY||LS Mean Difference|-0.31||||0.751|TWO_SIDED|95.0|-2.22|1.6|||ANCOVA|||||1.60|-2.22|0.751
71118013|NCT05463744|141740969|SUPERIORITY||Relative Rate|1.02||||0.9|TWO_SIDED|95.0|0.79|1.31|||Negative binomial model|||||1.31|0.79|0.900
71118014|NCT05463744|141740970|NON_INFERIORITY|0.4% noninferiority margin (NIM)|LS Mean Difference|0.024|STANDARD_ERROR_OF_MEAN|0.0682|||TWO_SIDED|95.0|-0.11|0.157|||ANCOVA|||||0.157|-0.110|
71118015|NCT05463744|141740971|SUPERIORITY||LS Mean Difference|-1.22||||0.697|TWO_SIDED|95.0|-7.38|4.93|||ANCOVA|||Week 26||4.93|-7.38|0.697
71118016|NCT05463744|141740971|SUPERIORITY||LS Mean Difference|-4.84||||0.163|TWO_SIDED|95.0|-11.64|1.96|||ANCOVA|||Week 52||1.96|-11.64|0.163
71118017|NCT05463744|141740972|SUPERIORITY||LS Mean Difference|0.02||||0.939|TWO_SIDED|95.0|-0.61|0.66|||Mixed Models Analysis|||Week 23 to Week 26||0.66|-0.61|0.939
71118018|NCT05463744|141740972|SUPERIORITY||LS Mean Difference|0.52||||0.116|TWO_SIDED|95.0|-0.13|1.17|||Mixed Models Analysis|||Week 49 to Week 52||1.17|-0.13|0.116
71118019|NCT05463744|141740973|SUPERIORITY||LS Mean Difference|0.54||||0.61|TWO_SIDED|95.0|-1.54|2.62|||ANCOVA|||||2.62|-1.54|0.610
71118020|NCT05463744|141740974|SUPERIORITY||LS Mean Difference|-8.96||||0.155|TWO_SIDED|95.0|-21.3|3.38|||Mixed Models Analysis|||Week 26||3.38|-21.30|0.155
71118021|NCT05463744|141740974|SUPERIORITY||LS Mean Difference|-6.88||||0.278|TWO_SIDED|95.0|-19.31|5.55|||Mixed Models Analysis|||Week 52||5.55|-19.31|0.278
71118022|NCT05463744|141740975|SUPERIORITY||LS Mean Difference|-3.77|||<|0.001|TWO_SIDED|95.0|-5.52|-2.03|||Mixed Models Analysis|||Week 26||-2.03|-5.52|<0.001
71118023|NCT05463744|141740975|SUPERIORITY||LS Mean Difference|-3.49|||<|0.001|TWO_SIDED|95.0|-5.26|-1.71|||Mixed Models Analysis|||Week 52||-1.71|-5.26|<0.001
71118024|NCT05463744|141740976|SUPERIORITY||LS Mean Difference|-39.28|||<|0.001|TWO_SIDED|95.0|-57.59|-20.98|||Mixed Models Analysis|||Week 26||-20.98|-57.59|<0.001
70942695|NCT01780584|141385762|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|10.0||||0.06||95.0|5.0|15.0|||Kruskal-Wallis|||Null hypothesis: there is no difference of postoperative hospital length of stay between groups. Statistical power 80% and level of significance 0.05.||15|5|0.06
70942696|NCT01772147|141385763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.127|||<|0.001|TWO_SIDED|95.0|0.089|0.164|||Mixed Models Analysis|||||0.164|0.089|<0.001
70942697|NCT01772147|141385763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.148|||<|0.001|TWO_SIDED|95.0|0.111|0.185|||Mixed Models Analysis|||||0.185|0.111|<0.001
70942698|NCT00796614|141385800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.5388|TWO_SIDED|95.0|0.5|3.8|||Regression, Logistic|||Logistic regression model was used with treatment variable and three covariates: age group, concomitant use of anti-cholinergic medication and geographic region. The first two covariates were used in the stratification of the randomisation. On treatment (OT) analyses approach was used.||3.80|0.50|0.5388
70942699|NCT00796614|141385800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.343|TWO_SIDED|95.0|0.2|1.76|||Regression, Logistic|||Logistic regression model was used with treatment variable and three covariates: age group, concomitant use of anti-cholinergic medication and geographic region. The first two covariates were used in the stratification of the randomisation. On treatment (OT) analyses approach was used.||1.76|0.20|0.3430
70942700|NCT00796614|141385800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.5209|TWO_SIDED|95.0|0.5|3.97|||Regression, Logistic|||Logistic regression model was used with treatment variable and three covariates: age group, concomitant use of anti-cholinergic medication and geographic region. The first two covariates were used in the stratification of the randomisation. On treatment (OT) analyses approach was used.||3.97|0.50|0.5209
71079882|NCT04227405|141667029|SUPERIORITY||Slope|1.35|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Positive Conflict Management subscale||||<.001
71079883|NCT04227405|141667029|SUPERIORITY||Slope|0.47|STANDARD_ERROR_OF_MEAN|0.23|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in Negative Conflict Management for the Control Group||||>.05
71118025|NCT05463744|141740976|SUPERIORITY||LS Mean Difference|-35.94|||<|0.001|TWO_SIDED|95.0|-54.44|-17.43|||Mixed Models Analysis|||Week 52||-17.43|-54.44|<0.001
71118026|NCT05463744|141740977|SUPERIORITY||LS Mean Difference|3.19|||<|0.001|TWO_SIDED|95.0|1.32|5.06|||Mixed Models Analysis|||Week 26||5.06|1.32|<0.001
71118027|NCT05463744|141740977|SUPERIORITY||LS Mean Difference|2.8||||0.004|TWO_SIDED|95.0|0.91|4.7|||Mixed Models Analysis|||Week 52||4.70|0.91|0.004
71118028|NCT05463744|141740978|SUPERIORITY||Relative Rate|1.21||||0.016|TWO_SIDED|95.0|1.04|1.41|||Negative binomial model|||||1.41|1.04|0.016
71118029|NCT05463744|141740979|SUPERIORITY||LS Mean Difference|0.086||||0.702|TWO_SIDED|95.0|-0.35|0.53|||Mixed Models Analysis|||Week 26||0.53|-0.35|0.702
71118030|NCT05463744|141740979|SUPERIORITY||LS Mean Difference|0.12||||0.609|TWO_SIDED|95.0|-0.33|0.56|||Mixed Models Analysis|||Week 52||0.56|-0.33|0.609
71118031|NCT05463744|141740980|SUPERIORITY||LS Mean Difference|0.03||||0.681|TWO_SIDED|95.0|-0.13|0.19|||ANCOVA|||Week 23 to Week 26||0.19|-0.13|0.681
71118032|NCT05463744|141740980|SUPERIORITY||LS Mean Difference|0.1||||0.182|TWO_SIDED|95.0|-0.05|0.24|||ANCOVA|||Week 49 to Week 52||0.24|-0.05|0.182
71118033|NCT05463744|141740981|SUPERIORITY||LS Mean Difference|0.0||||0.999|TWO_SIDED|95.0|-2.06|2.05|||ANCOVA|||Week 23 to Week 26||2.05|-2.06|0.999
71118034|NCT05463744|141740982|SUPERIORITY||LS Mean Difference|-0.83||||0.468|TWO_SIDED|95.0|-3.06|1.41|||ANCOVA|||||1.41|-3.06|0.468
71118035|NCT05463744|141740983|OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
71118036|NCT05463744|141740984|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71118037|NCT05463744|141740985|SUPERIORITY||LS Mean Difference|0.43||||0.27|TWO_SIDED|95.0|-0.33|1.19|||Mixed Models Analysis|||Physical Component Score: Week 26||1.19|-0.33|0.270
70942701|NCT00796614|141385800|SUPERIORITY_OR_OTHER|||||||0.9436|||||||Cochran-Armitage trend test|||A test of trend across the four treatment groups was performed as a secondary analysis in the proportion of responders across the dose levels using Cochran-Armitage trend test.||||0.9436
70942702|NCT00796614|141385801|SUPERIORITY_OR_OTHER|||||||0.3097|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.||||0.3097
70942703|NCT00796614|141385801|SUPERIORITY_OR_OTHER|||||||0.2676|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.||||0.2676
70942704|NCT00796614|141385801|SUPERIORITY_OR_OTHER|||||||0.6265|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.||||0.6265
71118038|NCT05463744|141740985|SUPERIORITY||LS Mean Difference|0.73||||0.05|TWO_SIDED|95.0|0.0|1.45|||Mixed Models Analysis|||Physical Component Score: Week 52||1.45|0.000|0.050
71118039|NCT05463744|141740985|SUPERIORITY||LS Mean Difference|0.22||||0.71|TWO_SIDED|95.0|-0.94|1.38|||Mixed Models Analysis|||Mental Component Score: Week 26||1.38|-0.94|0.710
71118040|NCT05463744|141740985|SUPERIORITY||LS Mean Difference|0.45||||0.447|TWO_SIDED|95.0|-0.71|1.61|||Mixed Models Analysis|||Mental Component Score: Week 52||1.61|-0.71|0.447
71118041|NCT01579565|141740995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.049||0.0001||95.0|0.494|0.686||p-value based on the generalized Cochran-Mantel-Haenszel (CMH) test stratified by the randomization strata.|Cochran-Mantel-Haenszel|CMH-weighted mean difference (OMS302 - Placebo) is adjusted for the randomization strata.||||0.686|0.494|0.0001
71118042|NCT01579565|141740996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.58|STANDARD_ERROR_OF_MEAN|1.192||0.0002||95.0|-6.917|-2.244||p-value is based on the generalized CMH test stratified by the randomization strata.|Cochran-Mantel-Haenszel|CMH-weighted mean difference (OMS302 - Placebo) is adjusted for the randomization strata.||||-2.244|-6.917|0.0002
70942705|NCT00796614|141385802|SUPERIORITY_OR_OTHER|||||||0.4359|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.||||0.4359
70942706|NCT00796614|141385802|SUPERIORITY_OR_OTHER|||||||0.0658|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.||||0.0658
70942707|NCT00796614|141385802|SUPERIORITY_OR_OTHER|||||||0.6709|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.||||0.6709
70942708|NCT00796614|141385803|SUPERIORITY_OR_OTHER|||||||0.5672|||||||Regression, Logistic|||Patient responded to tamsulosin-low dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.5672
70942709|NCT00796614|141385803|SUPERIORITY_OR_OTHER|||||||0.8724|||||||Regression, Logistic|||Patient responded to tamsulosin-medium dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.8724
70942710|NCT00796614|141385803|SUPERIORITY_OR_OTHER|||||||0.7674|||||||Regression, Logistic|||Patient responded to tamsulosin-high dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.7674
70942711|NCT00796614|141385803|SUPERIORITY_OR_OTHER|||||||0.5545|||||||Regression, Logistic|||Patient responded to tamsulosin-low dose (Right Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.5545
70942712|NCT00796614|141385803|SUPERIORITY_OR_OTHER|||||||0.4774|||||||Regression, Logistic|||Patient responded to tamsulosin-Medium dose (Right Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.4774
71079884|NCT04227405|141667029|SUPERIORITY||Slope|-1.48|STANDARD_ERROR_OF_MEAN|0.29|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in the Negative Conflict Management subscale||||<.01
70942713|NCT00796614|141385803|SUPERIORITY_OR_OTHER|||||||0.8626|||||||Regression, Logistic|||Patient responded to tamsulosin-High dose (Right Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use,and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.8626
71079885|NCT04227405|141667029|SUPERIORITY||Slope|-1.0|STANDARD_ERROR_OF_MEAN|0.36|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected decrease from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Negative Conflict Management subscale||||<.01
71079886|NCT04227405|141667029|SUPERIORITY||Slope|0.33|STANDARD_ERROR_OF_MEAN|0.14|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes in the Relationship Quality subscale from Pre-test to post-test in the control group||||<.05
71079887|NCT04227405|141667029|SUPERIORITY||Slope|0.86|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Changes in the Relationship Quality Subscale from pretest to posttest in the intervention group|A positive value indicates an increase while a negative value indicates a decrease|||<.001
71079888|NCT04227405|141667029|SUPERIORITY||Slope|0.53|STANDARD_ERROR_OF_MEAN|0.22|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Post-test in the Relationship Qualitty subscale|The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|||<.05
71079889|NCT04227405|141667029|SUPERIORITY||Slope|-0.32|STANDARD_ERROR_OF_MEAN|0.11|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Emotional Abuse subscale for the control group||||<.05
71118043|NCT01579565|141740997|SUPERIORITY_OR_OTHER|||||||0.0001||||||Chi-square test.|Chi-squared|||||||0.0001
71118044|NCT01579565|141740998|SUPERIORITY_OR_OTHER|||||||0.0001||||||Chi-square test|Chi-squared|||||||0.0001
70942714|NCT00796614|141385804|SUPERIORITY_OR_OTHER|||||||0.9669|||||||Regression, Logistic|||Patient responded to tamsulosin-low dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.9669
70942715|NCT00796614|141385804|SUPERIORITY_OR_OTHER|||||||0.9231|||||||Regression, Logistic|||Patient responded to tamsulosin-medium dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.9231
70942716|NCT00796614|141385804|SUPERIORITY_OR_OTHER|||||||0.636|||||||Regression, Logistic|||Patient responded to tamsulosin-high dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.6360
70942717|NCT00796614|141385804|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Patient responded to tamsulosin-low dose (Right Kidney) was compared to placebo. Fisher's exact test was used for this analysis.||||1.0000
70942718|NCT00796614|141385804|SUPERIORITY_OR_OTHER|||||||0.4925|||||||Fisher Exact|||Patient responded to tamsulosin-medium dose (Right Kidney) was compared to placebo. Fisher's exact test was used for this analysis.||||0.4925
71118045|NCT01579565|141740999|SUPERIORITY_OR_OTHER|||||||0.076||||||Chi-square test|Chi-squared|||||||0.0760
71118046|NCT01579565|141741000|SUPERIORITY_OR_OTHER|||||||0.0806||||||Chi-square test|Chi-squared|||||||0.0806
71118047|NCT01579565|141741001|SUPERIORITY_OR_OTHER|||||||0.0002||||||Generalized CMH test stratified by randomization strata.|Cochran-Mantel-Haenszel|||||||0.0002
71118048|NCT01579565|141741002|SUPERIORITY_OR_OTHER|||||||0.3923||||||Treatment comparisons are based on Cochran-Mantel-Haenszel test adjusting for the randomization strata.|Cochran-Mantel-Haenszel|||||||0.3923
71118049|NCT01579565|141741003|SUPERIORITY_OR_OTHER|||||||0.006||||||Treatment comparisons are based on Cochran-Mantel-Haenszel test adjusting for the randomization strata.|Cochran-Mantel-Haenszel|||||||0.0060
71118050|NCT01579565|141741004|SUPERIORITY_OR_OTHER|||||||0.3286||||||Treatment comparisons are based on generalized CMH test stratified by randomization strata.|Cochran-Mantel-Haenszel|||||||0.3286
71118051|NCT01579565|141741005|SUPERIORITY_OR_OTHER|||||||0.2361||||||Treatment comparisons based on Wilcoxon rank-sum test stratified by randomization strata.|Wilcoxon rank-sum test|||||||0.2361
71118052|NCT01448824|141741011|NON_INFERIORITY_OR_EQUIVALENCE|Up to 12 participants were enrolled in order for 8 to complete the study. The estimated variability in area under the concentration-time curve (AUC) was 20% coefficient of variation following a single dose of 100 mg LY2484595. Assuming that 70% of the total variability is contributed by intra-participant variability, a sample size of 8 participants provides a precision of \~15% for the geometric means ratio in AUC and Cmax of LY2484595 + ketoconazole to LY2484595 alone in log scale.|Ratio of Geometric LS Means|1.94|||||TWO_SIDED|90.0|1.39|2.72||||||||2.72|1.39|
71118053|NCT01448824|141741012|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||1|TWO_SIDED|90.0|-0.5|0.5|||Wilcoxon signed rank|||||0.50|-0.50|1.0000
71118054|NCT01448824|141741013|NON_INFERIORITY_OR_EQUIVALENCE|Up to 12 participants were enrolled in order for 8 to complete the study. The estimated variability in area under the concentration-time curve (AUC) was 20% coefficient of variation following a single dose of 100 mg LY2484595. Assuming that 70% of the total variability is contributed by intra-participant variability, a sample size of 8 participants provides a precision of \~15% for the geometric means ratio in AUC and Cmax of LY2484595 + ketoconazole to LY2484595 alone in log scale.|Ratio of Geometric LS means|2.37|||||TWO_SIDED|90.0|1.77|3.18||||||||3.18|1.77|
71118055|NCT03817463|141741023|OTHER||Adjusted Hazard Ratio|0.7|||<|0.005|TWO_SIDED|95.0|0.6|0.83|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||HHF-(broad+specific)||0.83|0.60|<0.005
71118056|NCT03817463|141741023|OTHER||Adjusted Hazard Ratio|0.66|||<|0.005|TWO_SIDED|95.0|0.57|0.78|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline||HHF-(broad + specific).||0.78|0.57|<0.005
71118057|NCT03817463|141741024|OTHER||Ajusted hazard ratio|0.75|||<|0.005|TWO_SIDED|95.0|0.69|0.81|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||HHF-broad.||0.81|0.69|<0.005
71118058|NCT03817463|141741024|OTHER||Ajusted hazard ratio|0.78|||<|0.005|TWO_SIDED|95.0|0.69|0.88|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||HHF-broad.||0.88|0.69|<0.005
71118059|NCT03817463|141741025|OTHER||Adjusted Hazard Ratio|0.68|||<|0.005|TWO_SIDED|95.0|0.56|0.83|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||HHF-specific. Hazards ratios reported include data from all countries with non-missing values.||0.83|0.56|<0.005
71118060|NCT03817463|141741025|OTHER||Adjusted Hazard Ratio|0.64|||<|0.005|TWO_SIDED|95.0|0.51|0.81|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||HHF-specific. Hazards ratios reported include data from all countries with non-missing values.||0.81|0.51|<0.005
71118061|NCT03817463|141741026|OTHER||Adjusted Hazard Ratio|0.55|||<|0.005|TWO_SIDED|95.0|0.48|0.63|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.63|0.48|<0.005
71118062|NCT03817463|141741026|OTHER||Adjusted Hazard Ratio|0.59|||<|0.005|TWO_SIDED|95.0|0.54|0.65|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.65|0.54|<0.005
71118063|NCT03817463|141741027|OTHER||Adjusted Hazard Ratio|0.65|||<|0.05|TWO_SIDED|95.0|0.56|0.76|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.76|0.56|<0.05
71118064|NCT03817463|141741027|OTHER||Adjusted Hazard Ratio|0.66|||<|0.005|TWO_SIDED|95.0|0.61|0.72|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.72|0.61|<0.005
71118065|NCT03817463|141741028|OTHER||Adjusted Hazard Ratio|0.72|||<|0.005|TWO_SIDED|95.0|0.64|0.82|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.82|0.64|<0.005
71118066|NCT03817463|141741028|OTHER||Adjusted Hazard Ratio|0.72|||<|0.005|TWO_SIDED|95.0|0.66|0.78|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.78|0.66|<0.005
71118067|NCT03817463|141741029|OTHER||Adjusted Hazard Ratio|1.02||||0.816|TWO_SIDED|95.0|0.88|1.18|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||1.18|0.88|0.816
71118068|NCT03817463|141741029|OTHER||Adjusted Hazard Ratio|0.87||||0.013|TWO_SIDED|95.0|0.78|0.97|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.97|0.78|0.013
71118069|NCT03817463|141741030|OTHER||Adjusted Hazard Ratio|0.82|||<|0.011|TWO_SIDED|95.0|0.71|0.96|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||0.96|0.71|<0.011
70942719|NCT00796614|141385804|SUPERIORITY_OR_OTHER|||||||0.4977|||||||Fisher Exact|||Patient responded to tamsulosin-high dose (Right Kidney) was compared to placebo. Fisher's exact test was used for this analysis.||||0.4977
70942720|NCT00796614|141385805|SUPERIORITY_OR_OTHER|||||||0.1373|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.1373
70942721|NCT00796614|141385805|SUPERIORITY_OR_OTHER|||||||0.744|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.7440
71118070|NCT03817463|141741030|OTHER||Adjusted Hazard Ratio|0.84||||0.064|TWO_SIDED|95.0|0.69|1.01|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.01|0.69|0.064
70942722|NCT00796614|141385805|SUPERIORITY_OR_OTHER|||||||0.7703|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.7703
70942723|NCT00796614|141385806|SUPERIORITY_OR_OTHER|||||||0.0808|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.0808
70942724|NCT00796614|141385806|SUPERIORITY_OR_OTHER|||||||0.8244|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.8244
70942725|NCT00796614|141385806|SUPERIORITY_OR_OTHER|||||||0.5045|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.5045
70942726|NCT03449134|141385815|OTHER||Estimated Percent Change Difference|-18.45||||0.041|TWO_SIDED|95.0|-32.92|-0.86||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 12 based on log transformed data.||-0.86|-32.92|0.041
71118071|NCT03817463|141741031|OTHER||Adjusted Hazard Ratio|0.59|||<|0.005|TWO_SIDED|95.0|0.42|0.84|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||0.84|0.42|<0.005
71118072|NCT03817463|141741031|OTHER||Adjusted Hazard Ratio|0.6|||<|0.005|TWO_SIDED|95.0|0.49|0.72|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||0.72|0.49|<0.005
71118073|NCT03817463|141741032|OTHER||Adjusted Hazard Ratio|0.54|||<|0.005|TWO_SIDED|95.0|0.46|0.64|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.64|0.46|<0.005
71118074|NCT03817463|141741032|OTHER||Adjusted Hazard Ratio|0.56|||<|0.005|TWO_SIDED|95.0|0.47|0.66|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.66|0.47|<0.005
71118075|NCT03817463|141741033|OTHER||Adjusted Hazard Ratio|0.95||||0.545|TWO_SIDED|95.0|0.81|1.11|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||1.11|0.81|0.545
71118076|NCT03817463|141741033|OTHER||Adjusted Hazard Ratio|0.91||||0.036|TWO_SIDED|95.0|0.83|0.99|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.99|0.83|0.036
71118077|NCT03817463|141741034|OTHER||Adjusted Hazard Ratio|0.93||||0.353|TWO_SIDED|95.0|0.79|1.09|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.09|0.79|0.353
71118078|NCT03817463|141741034|OTHER||Adjusted Hazard Ratio|0.9||||0.197|TWO_SIDED|95.0|0.78|1.05|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.05|0.78|0.197
71118079|NCT03817463|141741035|OTHER||Adjusted Hazard Ratio|0.43|||<|0.005|TWO_SIDED|95.0|0.3|0.63|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||0.63|0.30|<0.005
71118080|NCT03817463|141741035|OTHER||Adjusted Hazard Ratio|0.27|||<|0.005|TWO_SIDED|95.0|0.16|0.44|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||0.44|0.16|<0.005
71118081|NCT03817463|141741036|OTHER||Adjusted Hazard Ratio|1.05||||0.535|TWO_SIDED|95.0|0.89|1.25|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||1.25|0.89|0.535
71118082|NCT03817463|141741036|OTHER||Adjusted Hazard Ratio|0.98||||0.85|TWO_SIDED|95.0|0.84|1.15|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||1.15|0.84|0.850
71118083|NCT03817463|141741037|OTHER||Adjusted Hazard Ratio|1.03||||0.828|TWO_SIDED|95.0|0.81|1.31|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.31|0.81|0.828
71118084|NCT03817463|141741037|OTHER||Adjusted Hazard Ratio|1.01||||0.944|TWO_SIDED|95.0|0.72|1.42|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.42|0.72|0.944
71118085|NCT03817463|141741038|OTHER||Adjusted Hazard Ratio|0.94||||0.642|TWO_SIDED|95.0|0.73|1.22|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||1.22|0.73|0.642
71118086|NCT03817463|141741038|OTHER||Adjusted Hazard Ratio|0.89||||0.417|TWO_SIDED|95.0|0.66|1.19|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||1.19|0.66|0.417
71118087|NCT03817463|141741039|OTHER||Adjusted Hazard Ratio|0.89||||0.091|TWO_SIDED|95.0|0.77|1.02|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.02|0.77|0.091
71118088|NCT03817463|141741040|OTHER||Adjusted Hazard Ratio|1.97|||<|0.005|TWO_SIDED|95.0|1.28|3.03|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||3.03|1.28|<0.005
71118089|NCT03817463|141741041|OTHER||Adjusted Hazard Ratio|0.95||||0.654|TWO_SIDED|95.0|0.75|1.2|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.20|0.75|0.654
70854322|NCT02683746|141197108|OTHER||Mean Difference (Net)|0.07|||<|0.0001|TWO_SIDED|95.0|-0.07|0.2||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 8 are presented.|||0.20|-0.07|<0.0001
71118090|NCT03817463|141741042|OTHER||Adjusted Hazard Ratio|0.78||||0.233|TWO_SIDED|95.0|0.52|1.17|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.17|0.52|0.233
70854323|NCT02683746|141197108|OTHER||Mean Difference (Net)|0.08|||<|0.0001|TWO_SIDED|95.0|-0.08|0.24||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 12 are presented.|||0.24|-0.08|<0.0001
70854324|NCT02683746|141197108|OTHER||Mean Difference (Net)|0.02|||<|0.0001|TWO_SIDED|95.0|-0.16|0.2||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 16 are presented.|||0.20|-0.16|<0.0001
70854325|NCT02683746|141197108|OTHER||Mean Difference (Net)|0.02|||<|0.0001|TWO_SIDED|95.0|-0.15|0.19||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 20 are presented.|||0.19|-0.15|<0.0001
70854326|NCT02683746|141197108|OTHER||Mean Difference (Net)|0.01|||<|0.0001|TWO_SIDED|95.0|-0.17|0.2||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 26 are presented.|||0.20|-0.17|<0.0001
70854327|NCT02683746|141197109|OTHER||Mean Difference (Net)|0.25|||||TWO_SIDED|95.0|-0.15|0.65|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 1 are presented.|||0.65|-0.15|
70854328|NCT02683746|141197109|OTHER||Mean Difference (Net)|0.25|||||TWO_SIDED|95.0|-0.2|0.69|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 2 are presented.|||0.69|-0.20|
70854329|NCT02683746|141197109|OTHER||Mean Difference (Net)|-0.01|||||TWO_SIDED|95.0|-0.42|0.4|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 3 are presented.|||0.40|-0.42|
70854330|NCT02683746|141197109|OTHER||Mean Difference (Net)|-0.03|||||TWO_SIDED|95.0|-0.42|0.36|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 4 are presented.|||0.36|-0.42|
70854331|NCT02683746|141197109|OTHER||Mean Difference (Net)|0.19|||||TWO_SIDED|95.0|-0.19|0.57|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 5 are presented.|||0.57|-0.19|
70854332|NCT02683746|141197109|OTHER||Mean Difference (Net)|0.15|||||TWO_SIDED|95.0|-0.26|0.55|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 6 are presented.|||0.55|-0.26|
70854333|NCT02683746|141197109|OTHER||Mean Difference (Net)|0.27|||||TWO_SIDED|95.0|-0.16|0.71|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 7 are presented.|||0.71|-0.16|
70854334|NCT02683746|141197109|OTHER||Mean Difference (Net)|0.19|||||TWO_SIDED|95.0|-0.22|0.6|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 8 are presented.|||0.60|-0.22|
70854335|NCT02683746|141197109|OTHER||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.41|0.47|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 9 are presented.|||0.47|-0.41|
70854336|NCT02683746|141197109|OTHER||Mean Difference (Net)|0.15|||||TWO_SIDED|95.0|-0.28|0.57|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 10 are presented.|||0.57|-0.28|
70854337|NCT02683746|141197109|OTHER||Mean Difference (Net)|0.11|||||TWO_SIDED|95.0|-0.34|0.56|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 11 are presented.|||0.56|-0.34|
70854338|NCT02683746|141197109|OTHER||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.41|0.46|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 12 are presented.|||0.46|-0.41|
71118091|NCT03817463|141741043|OTHER||Adjusted Hazard Ratio|0.56|||<|0.005|TWO_SIDED|95.0|0.38|0.82|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||0.82|0.38|<0.005
70854339|NCT02683746|141197109|OTHER||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-0.47|0.57|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 13 are presented.|||0.57|-0.47|
70854340|NCT02683746|141197109|OTHER||Mean Difference (Net)|0.06|||||TWO_SIDED|95.0|-0.41|0.54|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 16 are presented.|||0.54|-0.41|
70854341|NCT02683746|141197109|OTHER||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.47|0.53|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 20 are presented.|||0.53|-0.47|
70854342|NCT02683746|141197109|OTHER||Mean Difference (Net)|-0.34|||||TWO_SIDED|95.0|-0.83|0.14|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 26 are presented.|||0.14|-0.83|
70854343|NCT04987944|141197111|OTHER||Least square mean difference|-9.8|||||TWO_SIDED|95.0|-24.5|5.0||||||||5.0|-24.5|
70854344|NCT04987944|141197112|OTHER||Least square mean difference|-3.9|||||TWO_SIDED|95.0|-19.4|11.5||||||||11.5|-19.4|
70854345|NCT04987944|141197113|OTHER||Least square mean difference|0.423|||||TWO_SIDED|95.0|-0.125|0.972||||||||0.972|-0.125|
70854346|NCT00345332|141197116|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||||||<0.01
70854347|NCT00345332|141197117|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||||||<0.01
70954217|NCT00688870|141411074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.4|||Chan and Zhang|||Additional serotypes - serotype 6A||4.4|-4.6|
71118092|NCT03817463|141741044|OTHER||Rate Ratio|0.74|||||TWO_SIDED|95.0|0.69|0.8|||||Poisson regression model was used.|Emergency room visits - Finland||0.80|0.69|
71118093|NCT03817463|141741044|OTHER||Rate Ratio|0.9|||||TWO_SIDED|95.0|0.59|1.38|||||Poisson regression model was used.|Emergency room visits - Japan||1.38|0.59|
71118094|NCT03817463|141741044|OTHER||Rate Ratio|0.91|||||TWO_SIDED|95.0|0.82|1.0|||||Poisson regression model was used.|Emergency room visits - South Korea||1.00|0.82|
71118095|NCT03817463|141741044|OTHER||Rate Ratio|0.72|||||TWO_SIDED|95.0|0.59|0.87|||||Poisson regression model was used.|Emergency room visit - Spain||0.87|0.59|
70854348|NCT04121078|141197118|EQUIVALENCE|Point estimate and its 90% confidence interval (CI) were calculated for Treatment B to Treatment A ratio of geometric means for Cmax based on the mixed-effect model of log-transformed Cmax with sequence, treatment, and period as fixed effects, and participant nested within sequence as a random effect. Bioequivalence was concluded if the 90% CI for the ratio of geometric means is entirely contained within 80% to 125% for Cmax. No adjustments were made for multiplicity.|Geometric Mean Ratio|6.24|||||TWO_SIDED|90.0|4.62|8.42||||||||8.42|4.62|
70942727|NCT03449134|141385815|OTHER||Estimated Percent Change Difference|1.56||||0.874|TWO_SIDED|95.0|-16.13|22.99||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 12 based on log transformed data.||22.99|-16.13|0.874
71118096|NCT03817463|141741044|OTHER||Rate Ratio|0.94|||||TWO_SIDED|95.0|0.87|1.01|||||Poisson regression model was used.|Emergency room visit - Sweden||1.01|0.87|
71118097|NCT03817463|141741044|OTHER||Rate Ratio|0.86|||||TWO_SIDED|95.0|0.8|0.93|||||Poisson regression model was used.|Emergency room visit - Taiwan||0.93|0.80|
71118098|NCT03817463|141741044|OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.75|0.85|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - Finland||0.85|0.75|
71118099|NCT03817463|141741044|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.68|0.84|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - Japan||0.84|0.68|
71118100|NCT03817463|141741044|OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.69|0.82|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - South Korea||0.82|0.69|
71118101|NCT03817463|141741044|OTHER||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.78|0.94|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - Norway||0.94|0.78|
71118102|NCT03817463|141741044|OTHER||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.66|0.89|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - Spain||0.89|0.66|
71118103|NCT03817463|141741044|OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.81|0.93|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - Sweden||0.93|0.81|
71118104|NCT03817463|141741044|OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.74|0.86|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - Taiwan||0.86|0.74|
71118105|NCT03817463|141741044|OTHER||Rate Ratio|0.68|||||TWO_SIDED|95.0|0.64|0.71|||||Poisson regression model was used.|All-cause hospital admissions||0.71|0.64|
71118106|NCT03817463|141741044|OTHER||Rate Ratio|0.69|||||TWO_SIDED|95.0|0.63|0.76|||||Poisson regression model was used.|For all-cause hospital admissions - Japan||0.76|0.63|
71118107|NCT03817463|141741044|OTHER||Rate Ratio|0.7|||||TWO_SIDED|95.0|0.66|0.75|||||Poisson regression model was used.|All-cause hospital admissions - South Korea||0.75|0.66|
71118108|NCT03817463|141741044|OTHER||Rate Ratio|0.81|||||TWO_SIDED|95.0|0.77|0.85|||||Poisson regression model was used.|All-cause hospital admissions - Norway||0.85|0.77|
71118109|NCT03817463|141741044|OTHER||Rate Ratio|0.68|||||TWO_SIDED|95.0|0.6|0.77|||||Poisson regression model was used.|All-cause hospital admissions - Spain||0.77|0.60|
71118110|NCT03817463|141741044|OTHER||Rate Ratio|0.85|||||TWO_SIDED|95.0|0.8|0.89|||||Poisson regression model was used.|All-cause hospital admissions - Sweden||0.89|0.80|
71118111|NCT03817463|141741044|OTHER||Rate Ratio|0.79|||||TWO_SIDED|95.0|0.72|0.87||||||All-cause hospital admissions - Taiwan||0.87|0.72|
71118112|NCT03817463|141741044|OTHER||Rate Ratio|0.78|||||TWO_SIDED|95.0|0.77|0.79|||||Poisson regression model was used.|Outpatient healthcare visits - Finland||0.79|0.77|
71118113|NCT03817463|141741044|OTHER||Rate Ratio|0.95|||||TWO_SIDED|95.0|0.94|0.97|||||Poisson regression model was used.|Outpatient healthcare visits - Japan||0.97|0.94|
71118114|NCT03817463|141741044|OTHER||Rate Ratio|0.97|||||TWO_SIDED|95.0|0.96|0.97|||||Poisson regression model was used.|Outpatient healthcare visits - South Korea||0.97|0.96|
71118115|NCT03817463|141741044|OTHER||Rate Ratio|0.96|||||TWO_SIDED|95.0|0.94|0.97||||||Outpatient healthcare visits - Norway||0.97|0.94|
71118116|NCT03817463|141741044|OTHER||Rate Ratio|0.88|||||TWO_SIDED|95.0|0.85|0.91|||||Poisson regression model was used.|Outpatient healthcare visit - Spain||0.91|0.85|
71118117|NCT03817463|141741044|OTHER||Rate Ratio|0.96|||||TWO_SIDED|95.0|0.94|0.98|||||Poisson regression model was used.|Outpatient healthcare visits - Sweden||0.98|0.94|
71118118|NCT03817463|141741044|OTHER||Rate Ratio|0.97|||||TWO_SIDED|95.0|0.94|1.0|||||Poisson regression model was used.|Outpatient healthcare visits - Taiwan||1.00|0.94|
71118119|NCT03817463|141741045|OTHER||Rate Ratio|0.91|||||TWO_SIDED|95.0|0.89|0.94|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different antidiabetic drugs - Japan||0.94|0.89|
71118120|NCT03817463|141741045|OTHER||Rate Ratio|0.86|||||TWO_SIDED|95.0|0.81|0.93|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different antidiabetic drugs - South Korea||0.93|0.81|
71118121|NCT03817463|141741045|OTHER||Rate Ratio|1.09|||||TWO_SIDED|95.0|1.08|1.11|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different antidiabetic drugs - Taiwan||1.11|1.08|
71118122|NCT03817463|141741045|OTHER||Rate Ratio|1.11|||||TWO_SIDED|95.0|1.1|1.12|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different drugs - Finland||1.12|1.10|
71118123|NCT03817463|141741045|OTHER||Rate Ratio|0.82|||||TWO_SIDED|95.0|0.81|0.83|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different drugs - Japan||0.83|0.81|
71118124|NCT03817463|141741045|OTHER||Rate Ratio|0.99|||||TWO_SIDED|95.0|0.99|1.0|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different drugs - South Korea||1.00|0.99|
71118125|NCT03817463|141741045|OTHER||Rate Ratio|1.12|||||TWO_SIDED|95.0|1.11|1.14|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different drugs - Norway||1.14|1.11|
70854349|NCT04121078|141197119|EQUIVALENCE|Point estimate and its 90% CI were calculated for Treatment B to Treatment A ratio of geometric means for AUC∞ based on the mixed-effect model of log-transformed AUC∞ with sequence, treatment, and period as fixed effects, and participant nested within sequence as a random effect. Bioequivalence was concluded if the 90% CI for the ratio of geometric means is entirely contained within 80% to 125% for AUC∞. No adjustments were made for multiplicity.|Geometric Mean Ratio|5.16|||||TWO_SIDED|90.0|4.25|6.25||||||||6.25|4.25|
70854350|NCT04121078|141197120|EQUIVALENCE|Point estimate and its 90% CI were calculated for Treatment B to Treatment A ratio of geometric means for AUClast based on the mixed-effect model of log-transformed AUClast with sequence, treatment, and period as fixed effects, and participant nested within sequence as a random effect. Bioequivalence was concluded if the 90% CI for the ratio of geometric means is entirely contained within 80% to 125% for AUClast. No adjustments were made for multiplicity.|Geometric Mean Ratio|5.21|||||TWO_SIDED|90.0|4.29|6.32||||||||6.32|4.29|
70942728|NCT03449134|141385818|OTHER||Estimated Percent Change Difference|-17.68||||0.056|TWO_SIDED|95.0|-32.57|0.5||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 12 based on log transformed data.||0.50|-32.57|0.056
71118126|NCT03817463|141741045|OTHER||Rate Ratio|1.26|||||TWO_SIDED|95.0|1.25|1.27|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different drugs - Sweden||1.27|1.25|
71118127|NCT03817463|141741045|OTHER||Rate Ratio|1.0|||||TWO_SIDED|95.0|0.98|1.02|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different drugs - Taiwan||1.02|0.98|
71118128|NCT03817463|141741045|OTHER||Rate Ratio|1.01|||||TWO_SIDED|95.0|1.01|1.02|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on prescriptions - Finland||1.02|1.01|
71118129|NCT03817463|141741045|OTHER||Rate Ratio|0.83|||||TWO_SIDED|95.0|0.82|0.84|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on prescriptions - Japan||0.84|0.82|
71118130|NCT03817463|141741045|OTHER||Rate Ratio|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on prescriptions - South Korea||1.01|0.99|
71118131|NCT03817463|141741045|OTHER||Rate Ratio|0.93|||||TWO_SIDED|95.0|0.92|0.93|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on prescriptions - Norway||0.93|0.92|
71118132|NCT03817463|141741045|OTHER||Rate Ratio|0.86|||||TWO_SIDED|95.0|0.84|0.87|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on prescriptions - Spain||0.87|0.84|
71118133|NCT03817463|141741045|OTHER||Rate Ratio|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on prescriptions - Sweden||1.00|1.00|
71118134|NCT03817463|141741046|OTHER||Rate Ratio|0.89|||||TWO_SIDED|95.0|0.83|0.94|||||Poisson regression model was used.|Total cost - Finland||0.94|0.83|
71118135|NCT03817463|141741046|OTHER||Rate Ratio|0.98|||||TWO_SIDED|95.0|0.86|1.12|||||Poisson regression model was used.|Total costs - Norway||1.12|0.86|
71118136|NCT03817463|141741046|OTHER||Rate Ratio|0.98|||||TWO_SIDED|95.0|0.92|1.05|||||Poisson regression model was used.|Total costs - Sweden||1.05|0.92|
71118137|NCT03817463|141741047|OTHER||Rate Ratio|0.84|||||TWO_SIDED|95.0|0.8|0.88|||||Poisson regression model was used.|||0.88|0.80|
71118138|NCT03817463|141741048|OTHER||Rate Ratio|0.76|||||TWO_SIDED|95.0|0.34|1.68|||||Poisson regression model was used.|Total costs - South Korea||1.68|0.34|
71118139|NCT03817463|141741049|OTHER||Rate Ratio|0.97|||||TWO_SIDED|95.0|0.92|1.03|||||Poisson regression model was used.|Total costs - Taiwan||1.03|0.92|
71118140|NCT02998203|141741073|OTHER|One-sample t-test|||||<|0.001|||||||One-sample t-test|||A one-sample t-test was used to assess whether the percent change was different than zero.||||<0.001
70854351|NCT02012582|141197154|SUPERIORITY_OR_OTHER||||||<|0.04|TWO_SIDED|||||Mixed model analysis for TIL with the patient as random effect and study day, cohort, treatment, and interaction between study day and treatment as fixed effects.|Mixed Models Analysis|||Placebo versus pooled VAS203 Arms/Groups||||<0.04
71079890|NCT04227405|141667029|SUPERIORITY||Slope|-0.71|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Changes from pre-test to posttest in the Emotional Abuse subscale for the intervention group|A positive value indicates an increase while a negative value indicates a decrease|||<.001
70854352|NCT02012582|141197155|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Kruskal-Wallis|||Placebo versus pooled VAS203 Arms/Group||||<0.01
70854353|NCT02673541|141197161|OTHER|||||||1|||||||Fisher Exact|||||||1
70942729|NCT03449134|141385818|OTHER||Estimated Percent Change Difference|2.95||||0.77|TWO_SIDED|95.0|-15.33|25.19||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 12 based on log transformed data.||25.19|-15.33|0.770
70942730|NCT03449134|141385819|OTHER||Odds Ratio (OR)|1.2||||0.416|TWO_SIDED|95.0|0.77|1.86|||Regression, Logistic|||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline, and the interaction of baseline (underlying continuous response) by visit as covariates.||1.86|0.77|0.416
71079891|NCT04227405|141667029|SUPERIORITY||Slope|-0.39|STANDARD_ERROR_OF_MEAN|0.16|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Post-test in the Emotional Abuse subscale|The expected decrease from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|||<.05
71079892|NCT04227405|141667029|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Changes from pre-test to posttest in the Relationship Satisfaction subscale for the control group|A positive value indicates an increase while a negative value indicates a decrease|||>.05
70871980|NCT00279305|141229293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.104||0.05|TWO_SIDED|95.0|-0.0699|0.348|||ANCOVA|||"The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the AUC mean and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis."||0.348|-0.0699|0.05
70942731|NCT03449134|141385819|OTHER||Odds Ratio (OR)|1.01||||0.948|TWO_SIDED|95.0|0.66|1.55|||Regression, Logistic|||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline, and the interaction of baseline (underlying continuous response) by visit as covariates.||1.55|0.66|0.948
70942732|NCT03449134|141385820|OTHER||Odds Ratio (OR)|1.39|||||TWO_SIDED|95.0|0.94|2.05||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline CSD score, and the interaction of baseline (underlying continuous response) by visit as covariates.||2.05|0.94|
70942733|NCT03449134|141385820|OTHER||Odds Ratio (OR)|1.48|||||TWO_SIDED|95.0|1.01|2.18||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline CSD score, and the interaction of baseline (underlying continuous response) by visit as covariates.||2.18|1.01|
70942734|NCT03449134|141385821|OTHER||Odds Ratio (OR)|1.68|||||TWO_SIDED|95.0|1.11|2.54||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline CSD score, and the interaction of baseline (underlying continuous response) by visit as covariates.||2.54|1.11|
71079893|NCT04227405|141667029|SUPERIORITY||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Changes from pre-test to posttest in the Relationship satisfaction subscale for the intervention group||||<.001
70871981|NCT03919799|141229332|SUPERIORITY|The LOCF imputation was followed by logistic regression analysis. Comparison analysis between belumosudil dose regimen and placebo was performed using a logistic regression analysis with treatment in the model.|Odds Ratio (OR)|1.06||||0.9472|TWO_SIDED|95.0|0.19|5.82||Threshold for significance at 0.05 level.|Regression, Logistic|||Belumosudil 200 mg QD versus Placebo||5.82|0.19|0.9472
70942735|NCT03449134|141385821|OTHER||Odds Ratio (OR)|1.53|||||TWO_SIDED|95.0|1.01|2.3||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline CSD score, and the interaction of baseline (underlying continuous response) by visit as covariates.||2.30|1.01|
70942736|NCT03449134|141385822|OTHER||Odds Ratio (OR)|1.54|||||TWO_SIDED|95.0|1.03|2.3||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline VAS score, and the interaction of baseline (underlying continuous response) by visit as covariates.||2.30|1.03|
70942737|NCT03449134|141385822|OTHER||Odds Ratio (OR)|1.27|||||TWO_SIDED|95.0|0.86|1.89||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline VAS score, and the interaction of baseline (underlying continuous response) by visit as covariates.||1.89|0.86|
70942738|NCT03449134|141385823|OTHER||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|0.85|1.98||||||Comparison based on a logistic regression model that included visit, treatment-by-visit interaction, gender, region, baseline LCQ score, and the interaction of baseline (underlying continuous response) by visit as covariates.||1.98|0.85|
70942739|NCT03449134|141385823|OTHER||Odds Ratio (OR)|1.39|||||TWO_SIDED|95.0|0.92|2.12||||||Comparison based on a logistic regression model that included visit, treatment-by-visit interaction, gender, region, baseline LCQ score, and the interaction of baseline (underlying continuous response) by visit as covariates.||2.12|0.92|
70942740|NCT00275301|141385839|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Regression, Linear|||Examination of relationship between Borderline Personality Disorder symptoms and brain metabolism at baseline.||||<0.05
70942741|NCT02097849|141385840|SUPERIORITY_OR_OTHER||Difference in proportion|-0.04||||0.692|TWO_SIDED|95.0|-0.27|0.19|||Clopper-Pearson Exact|||||0.19|-0.27|0.692
70942742|NCT02097849|141385841|SUPERIORITY_OR_OTHER||Difference in proportion|-0.19||||0.12|TWO_SIDED|95.0|-0.41|0.05|||Clopper-Pearson Exact|||Responders at Day 28||0.05|-0.41|0.120
70942743|NCT02097849|141385842|SUPERIORITY_OR_OTHER||Difference in proportions|-0.13||||0.225|TWO_SIDED|95.0|-0.35|0.1|||Clopper-Pearson Exact|||||0.10|-0.35|0.225
70942744|NCT02097849|141385843|SUPERIORITY_OR_OTHER||Difference in proportions|-0.22||||0.057|TWO_SIDED|95.0|-0.44|0.01|||Clopper-Pearson Exact|||||0.01|-0.44|0.057
70942745|NCT02097849|141385844|SUPERIORITY_OR_OTHER||Difference in proportions|0.07||||0.3|TWO_SIDED|95.0|-0.16|0.3|||Clopper-Pearson Exact|||||0.30|-0.16|0.300
70942746|NCT02097849|141385845|SUPERIORITY_OR_OTHER||Difference in proportions|-0.03||||0.714|TWO_SIDED|95.0|-0.26|0.2|||Clopper-Pearson Exact|||||0.20|-0.26|0.714
70942747|NCT02097849|141385846|SUPERIORITY_OR_OTHER||Difference in proportions|0.0||||0.967|TWO_SIDED|95.0|-0.24|0.23|||Clopper-Pearson Exact|||||0.23|-0.24|0.967
70942748|NCT02097849|141385847|SUPERIORITY_OR_OTHER||Difference in proportions|-0.01||||0.955|TWO_SIDED|95.0|-0.24|0.22|||Clopper-Pearson Exact|||||0.22|-0.24|0.955
70942749|NCT02561078|141385856|NON_INFERIORITY|The test for the primary objective of noninferiority was performed at the 0.05 significance level using the LS Mean estimate of the difference in change in HbA1c between the 2 treatments at Week 26. Noninferiority was established if the upper limit of a 2-sided 95% confidence interval (CI) for the difference (U 500R CSII minus U 500R MDI) was below the noninferiority margin (NIM) of 0.4%.|Mean Difference (Net)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.62|-0.22|||Mixed Models Analysis|||||-0.22|-0.62|<0.001
70942750|NCT02561078|141385857|SUPERIORITY||Mean Difference (Net)|-35.6|||<|0.001|TWO_SIDED|95.0|-49.4|-21.7|||Mixed Models Analysis|||||-21.7|-49.4|<0.001
70942751|NCT02561078|141385858|SUPERIORITY||Odds Ratio (OR)|1.97||||0.015|TWO_SIDED|95.0|1.14|3.39|||Regression, Logistic|||||3.39|1.14|0.015
70942752|NCT02561078|141385859|SUPERIORITY||Odds Ratio (OR)|1.94||||0.005|TWO_SIDED|95.0|1.23|3.07|||Regression, Logistic|||||3.07|1.23|0.005
70942753|NCT02561078|141385860|SUPERIORITY||Mean Difference (Net)|-22.5|||<|0.001|TWO_SIDED|95.0|-32.1|-12.8|||Mixed Models Analysis|||Pre Morning Meal||-12.8|-32.1|<0.001
70942754|NCT02561078|141385860|SUPERIORITY||Mean Difference (Net)|-17.2||||0.008|TWO_SIDED|95.0|-29.9|-4.6|||Mixed Models Analysis|||2 Hours Post Morning Meal||-4.6|-29.9|0.008
70942755|NCT02561078|141385860|SUPERIORITY||Mean Difference (Net)|-8.9||||0.138|TWO_SIDED|95.0|-20.6|2.9|||Mixed Models Analysis|||Pre Mid-Day Meal||2.9|-20.6|0.138
70942756|NCT02561078|141385860|SUPERIORITY||Mean Difference (Net)|8.3||||0.16|TWO_SIDED|95.0|-3.3|19.8|||Mixed Models Analysis|||2 Hours Post Mid-Day Meal||19.8|-3.3|0.160
70942757|NCT02561078|141385860|SUPERIORITY||Mean Difference (Net)|9.1||||0.113|TWO_SIDED|95.0|-2.2|20.4|||Mixed Models Analysis|||Pre Evening Meal||20.4|-2.2|0.113
70942758|NCT02561078|141385860|SUPERIORITY||Mean Difference (Net)|16.7||||0.004|TWO_SIDED|95.0|5.3|28.2|||Mixed Models Analysis|||2 Hours Post Evening Meal||28.2|5.3|0.004
70942759|NCT02561078|141385860|SUPERIORITY||Mean Difference (Net)|0.6||||0.905|TWO_SIDED|95.0|-9.5|10.8|||Mixed Models Analysis|||Overnight (3:00 AM)||10.8|-9.5|0.905
70942760|NCT02561078|141385861|SUPERIORITY||Mean Difference (Net)|-48.4|||<|0.001|TWO_SIDED|95.0|-74.1|-22.8|||Mixed Models Analysis|||||-22.8|-74.1|<0.001
70942761|NCT02561078|141385862|SUPERIORITY||Odds Ratio (OR)|1.05||||0.919|TWO_SIDED|95.0|0.39|2.86|||Regression, Logistic|||||2.86|0.39|0.919
70942762|NCT02561078|141385863|SUPERIORITY||Relative Rate|1.21||||0.025|TWO_SIDED|95.0|1.02|1.42|||Negative binomial regression|||||1.42|1.02|0.025
70942763|NCT02561078|141385864|SUPERIORITY||Mean Difference (Net)|0.8||||0.1|TWO_SIDED|95.0|-0.2|1.8|||Mixed Models Analysis|||||1.8|-0.2|0.100
70942764|NCT00821119|141385902|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7|STANDARD_ERROR_OF_MEAN|0.16|<|0.05|TWO_SIDED|95.0|0.48|1.14|||risk ratio (RR)|||"Based on previous data from our NICU, 40 - 45% of our preterm infants administered early NCPAP for RDS needed intubation and mechanical ventilation within the first 72h of life. We estimated a 20% absolute reduction in the need of using ETT ventilation with the early use of NIPPV. A sample size of 100 infants per group was calculated with a power of 80% and an alpha error of 5%.~The analysis was performed according to the intention-to-treat principle."||1.14|0.48|<0.05
70942765|NCT00821119|141385903|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7|STANDARD_ERROR_OF_MEAN|0.16||0.05|TWO_SIDED|95.0|0.48|1.14|||risk ratio (RR)|||Based on previous data from our NICU, 40 - 45% of our preterm infants administered early NCPAP for RDS needed intubation and mechanical ventilation within the first 72h of life. We estimated a 20% absolute reduction in the need of using ETT ventilation with the early use of NIPPV. A sample size of 100 infants per group was calculated with a power of 80% and an alpha error of 5%.||1.14|0.48|0.05
70942766|NCT00821119|141385904|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.06|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED|95.0|0.62|1.78|||risk ratio (RR)|||The study was not powered for this outcome. However this analysis was done with this limitation||1.78|0.62|< 0.05
70854354|NCT04740905|141197166|NON_INFERIORITY|If the lower bound of a two-sided 95% confidence interval (CI) for the difference in adjusted means of the two treatments (faricimab minus aflibercept) is greater than -4 letters (the non-inferiority margin), then faricimab is considered non-inferior to aflibercept.|Difference in Adjusted Means|-0.6|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|95.0|-2.2|1.1|||||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|The null hypothesis, H0: μ(faricimab) - μ(aflibercept) ≤-4 letters; the alternative hypothesis, Ha: μ(faricimab) - μ(aflibercept) \>-4 letters. The final sample size provided \>90% power for the non-inferiority assessment (at a one-sided 0.02485 significance level).||1.1|-2.2|
70854355|NCT04740905|141197166|SUPERIORITY||Difference in Adjusted Means|-0.6|STANDARD_ERROR_OF_MEAN|0.84||0.4978|TWO_SIDED|95.0|-2.2|1.1||Tested at a two-sided 0.0497 significance level.|Mixed Model of Repeated Measures||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|The final sample size provided \>80% power for a 3.5-letter superiority assessment of faricimab over aflibercept.||1.1|-2.2|0.4978
70854356|NCT04740905|141197168|OTHER||Difference in CMH Weighted Percentage|-4.3|||||TWO_SIDED|95.0|-12.3|3.8||||||||3.8|-12.3|
70854357|NCT04740905|141197184|OTHER||Difference in Adjusted Means|-0.4|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-1.9|1.1||||||||1.1|-1.9|
70854358|NCT02700334|141197214|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
70854359|NCT02700334|141197215|OTHER|||||||0.093|||||||Wilcoxon (Mann-Whitney)|||||||0.093
70854360|NCT02700334|141197216|OTHER|||||||0.878|||||||Wilcoxon (Mann-Whitney)|||||||0.878
70854361|NCT02700334|141197217|OTHER|||||||0.959|||||||Wilcoxon (Mann-Whitney)|||||||0.959
70854362|NCT02700334|141197218|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
70854363|NCT02700334|141197219|OTHER|||||||0.331|||||||Wilcoxon (Mann-Whitney)|||||||0.331
70854364|NCT02700334|141197220|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
70854365|NCT02700334|141197221|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
70854366|NCT02700334|141197222|OTHER|||||||0.575|||||||Wilcoxon (Mann-Whitney)|||||||0.575
70854367|NCT02700334|141197223|OTHER|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||||||0.314
70854368|NCT02700334|141197224|OTHER|||||||0.721|||||||Wilcoxon (Mann-Whitney)|||||||0.721
70854369|NCT02700334|141197225|OTHER|||||||0.066|||||||Wilcoxon (Mann-Whitney)|||||||0.066
70854370|NCT02700334|141197226|OTHER|||||||0.333|||||||Wilcoxon (Mann-Whitney)|||||||0.333
70854371|NCT02700334|141197227|OTHER|||||||0.859|||||||Wilcoxon (Mann-Whitney)|||||||0.859
70854372|NCT02700334|141197228|OTHER|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
70854373|NCT02700334|141197229|OTHER|||||||0.919|||||||Wilcoxon (Mann-Whitney)|||||||0.919
70854374|NCT02700334|141197230|OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.720
70854375|NCT02412488|141197235|OTHER|"The goal of the primary study objective was to estimate the rate of untoward events associated with Reveal LINQ insertions performed in the out-of-cathlab setting through 3-months within a desired level of precision. The target sample size of approximately 200 subjects undergoing Reveal LINQ insertion was selected to ensure that the upper 95% confidence interval would be within 3 percentage points of the point estimate of the untoward event rate assuming the underlying rate was 2%"|Event Rate expressed as a percent|0.0|||||TWO_SIDED|95.0|0.0|2.1|||||The estimate is the observed rate of untoward events expressed as a percentage. The 95% confidence interval is also expressed as a percentage|"There was no formal statistical hypothesis test associated with the primary outcome measure. Rather the goal of the primary study objective was to estimate the rate of untoward events associated with Reveal LINQ insertions performed in the out-of-cathlab setting through 3-months within a desired level of precision."||2.1|0|
70854376|NCT03222492|141197250|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||1.000
70854377|NCT03222492|141197250|SUPERIORITY|||||||0.444||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||0.444
70854378|NCT03222492|141197251|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||1.000
70942767|NCT03935932|141385905|OTHER|||||||0.11|||||||Wilcoxon signed-rank|||||||0.11
70854379|NCT03222492|141197251|SUPERIORITY|||||||0.4||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||0.400
70854380|NCT03222492|141197252|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||1.000
70854381|NCT03222492|141197252|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||1.000
70854382|NCT03222492|141197252|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||1.000
70854383|NCT03222492|141197252|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||1.000
70854384|NCT03222492|141197252|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 36||||1.000
70854385|NCT03222492|141197252|SUPERIORITY|||||||0.5||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 36||||0.500
70942768|NCT03935932|141385906|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
70942769|NCT03935932|141385907|OTHER|||||||0.35|||||||Wilcoxon signed-rank|||||||0.35
70854386|NCT03222492|141197253|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||1.000
71118141|NCT02998203|141741074|OTHER|non-parametric Wilcoxon rank sum test|||||<|0.001|||||||Wilcoxon rank sum test|||The overall differences in the medians of biomarkers between the conventional and the organic periods were assessed with the non-parametric Wilcoxon rank sum test||||<0.001
70854387|NCT03222492|141197253|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||1.000
70854388|NCT03222492|141197254|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||1.000
71118142|NCT02998203|141741075|OTHER|Linear mixed-effect regression model|||||<|0.001||||||Multiple testing was accounted for using the Benjamini-Hochberg method, considering 58 regression parameter tests of the aforementioned models. Q-value\<0.05 were considered statistically significant (controlling the false discovery rate at 5%).|Mixed Models Analysis|||||||<0.001
70942770|NCT03924947|141385908|NON_INFERIORITY|The pre-specified non-inferiority margin of upper bound of the two-sided 99% confidence interval for the treatment difference was 12%.|Least Squares (LS) Mean of Difference|0.94|STANDARD_ERROR_OF_MEAN|1.176|||TWO_SIDED|99.0|-2.37|4.259|||||LS mean (standard error \[SE\]) and LS mean confidence interval (CI) are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|Double Blind Creon - Double Blind Creon MP||4.259|-2.370|
70942771|NCT03924947|141385909|OTHER|Descriptive|LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|1.169|||TWO_SIDED|95.0|-2.456|2.392|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|Creon - Creon MP||2.392|-2.456|
70942772|NCT03924947|141385909|OTHER|Descriptive|LS Mean of Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.035|||TWO_SIDED|95.0|-3.005|1.345|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|Creon - Creon AAPIS||1.345|-3.005|
70942773|NCT03924947|141385910|OTHER|Descriptive|LS Mean of Difference|-3.36|STANDARD_ERROR_OF_MEAN|3.541|||TWO_SIDED|95.0|-10.699|3.987|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|Creon - Creon MP||3.987|-10.699|
70942774|NCT03924947|141385910|OTHER|Descriptive|LS Mean of Difference|3.27|STANDARD_ERROR_OF_MEAN|4.016|||TWO_SIDED|95.0|-5.172|11.702|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|DB Creon - DB Creon AAPIS||11.702|-5.172|
70942775|NCT03924947|141385911|OTHER|Descriptive|LS Mean of Difference|34.68|STANDARD_ERROR_OF_MEAN|62.253|||TWO_SIDED|95.0|-94.424|163.786|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|Creon - Creon MP||163.786|-94.424|
70942776|NCT03924947|141385911|OTHER|Descriptive|LS Mean of Difference|-16.56|STANDARD_ERROR_OF_MEAN|60.858|||TWO_SIDED|95.0|-144.418|111.298|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|DB Creon - DB Creon AAPIS||111.298|-144.418|
70942777|NCT03924947|141385912|NON_INFERIORITY|The pre-specified non-inferiority margin of upper bound of the two-sided 99% confidence interval for the treatment difference was 12%.|LS Mean of Difference|-1.15|STANDARD_ERROR_OF_MEAN|1.302|||TWO_SIDED|99.0|-4.892|2.602|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|Double Blind Creon - Double Blind Creon AAPIS||2.602|-4.892|
70942778|NCT01797822|141385949|OTHER|Statistical comparison between groups was made with t-test. A sample size of 20 subjects was calculates to have 90% power of detecting a statistical difference (P\<0.05) in change in corneal staining pre and post low humidity challenge.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
71118143|NCT02998203|141741076|OTHER|Wilcoxon rank sum test||||||0.017|||||||Wilcoxon rank sum test|||The overall differences in the medians of biomarkers between the conventional and the organic periods were assessed with the non-parametric Wilcoxon rank sum test||||0.017
70942779|NCT02253147|141386030|NON_INFERIORITY|"A WSRS change of 1 grade is considered to be clinically significant. A difference of ≤0.5 grade between the two treatment groups (i.e., half of the clinically significant difference) = non-inferiority margin.~The primary efficacy endpoint uses a paired-design and is analyzed by calculating two-sided confidence intervals of the mean difference between TEOSYAL® RHA UD and the control device, between the V1 enrollment visit (baseline) and V7 (24 weeks after baseline)."|Mean Difference (Final Values)|-0.22|||||TWO_SIDED|95.0|-0.34|-0.11|||||The decision is based on the upper limit of the 2-sided confidence interval for the difference for the change from baseline, between test and comparator treatment. For achieving non-inferiority, the upper confidence limit of a 95.0% CI must be ≤0.5|"Efficacy of TEOSYAL® RHA Ultra Deep versus control is analyzed in a non-inferiority statistical model using the 5-grade Wrinkle Severity Rating Scale (WSRS) as rated by the Blinded Live Evaluator at 24 weeks after baseline.~The primary endpoint is the aesthetic improvement from pre-injection of the NLF at the side of the face treated with TEOSYAL® RHA Ultra Deep compared to the one at the side of the face treated with the control device, as assessed by the BLE at 24 weeks after baseline."||-0.11|-0.34|
70942780|NCT00843115|141386065|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5.||||<0.0001
70942781|NCT00843115|141386066|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5.||||<0.0001
70942782|NCT00843115|141386067|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
70942783|NCT00843115|141386068|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
70942784|NCT00843115|141386069|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
70942785|NCT00843115|141386070|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
70942786|NCT00843115|141386071|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
70942787|NCT00843115|141386072|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
70942788|NCT00843115|141386073|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
70942789|NCT00843115|141386074|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
70942790|NCT00843115|141386075|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
70942791|NCT00843115|141386076|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
71079894|NCT04227405|141667029|SUPERIORITY||Slope|0.26|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Relationship Satisfactionn subscale||||<.001
70854389|NCT03222492|141197254|SUPERIORITY|||||||0.467||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||0.467
70942792|NCT00843115|141386077|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
70942793|NCT00843115|141386078|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
70854390|NCT03222492|141197255|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 36||||1.000
71118144|NCT02998203|141741077|OTHER|Logistic mixed-effect model||||||0.014||||||Multiple testing was accounted for using the Benjamini-Hochberg method, considering 58 regression parameter tests of the aforementioned models. Q-value\<0.05 were considered statistically significant (controlling the false discovery rate at 5%).|Mixed Models Analysis|||||||0.014
70854391|NCT03222492|141197255|SUPERIORITY|||||||0.4||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 36||||0.400
70854392|NCT03222492|141197256|SUPERIORITY|||||||0.464||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||0.464
70854393|NCT03222492|141197256|SUPERIORITY|||||||0.5||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||0.500
71118145|NCT02998203|141741078|OTHER|One-sample t-test||||||0.167|||||||One-sample t-test|||A one-sample t-test was used to assess whether the percent change was different than zero.||||0.167
71118146|NCT02998203|141741079|OTHER|Wilcoxon rank sum test||||||0.07|||||||Wilcoxon rank sum test|||The overall differences in the medians of biomarkers between the conventional and the organic periods were assessed with the non-parametric Wilcoxon rank sum test||||0.07
71118147|NCT02998203|141741080|OTHER|Linear mixed-effect regression model||||||0.014||||||Multiple testing was accounted for using the Benjamini-Hochberg method, considering 58 regression parameter tests of the aforementioned models. Q-value\<0.05 were considered statistically significant (controlling the false discovery rate at 5%).|Mixed Models Analysis|||||||0.014
71118148|NCT02998203|141741081|OTHER|One-sample t-test||||||0.023|||||||One-sample t-test|||A one-sample t-test was used to assess whether the percent change was different than zero.||||0.023
71118149|NCT02998203|141741082|OTHER|Wilcoxon rank sum test||||||0.259|||||||Wilcoxon rank sum test|||The overall differences in the medians of biomarkers between the conventional and the organic periods were assessed with the non-parametric Wilcoxon rank sum test||||0.259
71118150|NCT02998203|141741083|OTHER|Linear mixed-effect regression model|||||<|0.001||||||Multiple testing was accounted for using the Benjamini-Hochberg method, considering 58 regression parameter tests of the aforementioned models. Q-value\<0.05 were considered statistically significant (controlling the false discovery rate at 5%).|Mixed Models Analysis|||The interaction term for time and treatment was included in the models since it met the threshold of p-value\<0. 05. Specifically, for the interaction term of time and organic treatment b=-0.016, 95% CI=\[-0.023,-0.010\], p-value=\<0.001.||||<0.001
71118151|NCT02998203|141741084|OTHER|One-sample t-test||||||0.913|||||||One-sample t-test|||A one-sample t-test was used to assess whether the percent change was different than zero.||||0.913
71118152|NCT02998203|141741085|OTHER|Wilcoxon rank sum test||||||0.338|||||||Wilcoxon rank sum test|||The overall differences in the medians of biomarkers between the conventional and the organic periods were assessed with the non-parametric Wilcoxon rank sum test||||0.338
71118153|NCT02998203|141741086|OTHER|Linear mixed-effect regression model||||||0.001||||||Multiple testing was accounted for using the Benjamini-Hochberg method, considering 58 regression parameter tests of the aforementioned models. Q-value\<0.05 were considered statistically significant (controlling the false discovery rate at 5%).|Mixed Models Analysis|||The interaction term for time and treatment was included in the models since it met the threshold of p-value\<0. 05. Specifically, for the interaction term of time and organic treatment b=-0.016, 95% CI=\[-0.023,-0.010\], p-value=0.01.||||0.001
71118154|NCT03389555|141741087|EQUIVALENCE|Equivalence margin: if confidence interval for mean difference between SOFA scores at 72 hour time-point for two groups overlaps 0 (p-value \> 0.05) scores considered to be equivalent. Note: The model estimates the mean difference in SOFA score at 72 hours between treatment and control groups, for those patient for whom a SOFA score could be calculated at the 72 hour time point (i.e patients that were alive at the 72 hour time point, 90 patients in the treatment and 88 patients in the control).|Mean Difference (Net)|-0.8||||0.12|TWO_SIDED|95.0|-1.7|0.2||A priori threshold for significance, p-value \< 0.05|Mixed Models Analysis|||The primary outcome was analyzed using a linear mixed-effects model where the correlation of within-patient repeated SOFA score measures was accounted for via the use of an unstructured variance-covariance matrix and linear contrasts. Covariates included age, sex, treatment group, time, and the interaction between treatment group and time. Study site was included as a random intercept. The model estimates the mean difference in SOFA score at 72 hours between treatment and control groups.||0.2|-1.7|0.12
71118155|NCT03389555|141741088|EQUIVALENCE|For the key secondary outcome of kidney failure, 200 patients were estimated to provide 94% power, assuming that 30% of participants in the treatment group and 55% in the placebo group would develop kidney failure. If the adjusted risk difference from the logistic regression analysis overlaps 0, there was considered to be no difference between groups|Risk Difference (RD)|3.0||||0.58|TWO_SIDED|95.0|-10.0|20.0|||Regression, Logistic|||Logistic regression analysis evaluating the key secondary outcome of kidney failure in treatment group (intervention versus placebo) controlling for treatment site.||20.0|-10.0|0.58
71118156|NCT03389555|141741089|EQUIVALENCE|If confidence interval for hazard ratio crosses 0, hazard of death assumed to be equivalent in the two groups.|Hazard Ratio (HR)|1.3||||0.05|TWO_SIDED|95.0|0.8|2.2|||Regression, Cox|||Cox Regression controlling for site used to identify hazard ratio for outcome of death for treatment versus intervention group. Null hypothesis is that hazard ratio is 1.||2.2|0.8|0.05
71118157|NCT03389555|141741090|EQUIVALENCE|If the confidence interval for the median difference in ventilator free days between groups crosses 0, the two groups are considered equivalent.|Median Difference (Net)|0.0|||>|0.99|TWO_SIDED|95.0|-1.9|1.9|||Quantile Regression|||Quantile regression controlling for site performed to compare treatment and control group's ventilator free days.||1.9|-1.9|>0.99
71118158|NCT03389555|141741091|EQUIVALENCE|If the confidence interval for the median difference in shock free days between groups crosses 0, the two groups are considered equivalent.|Median Difference (Net)|1.0||||0.02|TWO_SIDED|95.0|0.2|1.8|||Quantile Regression|||Quantile regression controlling for site performed to compare treatment and control group's shock free days.||1.8|0.2|0.02
71118159|NCT03389555|141741092|EQUIVALENCE|If the confidence interval for the median difference in ICU free days between groups crosses 0, the two groups are considered equivalent.|Median Difference (Net)|1.0||||0.69|TWO_SIDED|95.0|-3.0|6.0|||Quantile Regression|||Quantile regression controlling for site performed to compare treatment and control group's ICU free days.||6.0|-3.0|0.69
70942794|NCT00843115|141386079|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
70942795|NCT00843115|141386080|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
70942796|NCT00843115|141386081|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
70942797|NCT00843115|141386082|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
70942798|NCT00843115|141386083|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate @ 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
70942799|NCT00843115|141386084|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
70942800|NCT00843115|141386085|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
70942801|NCT00843115|141386086|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero.||Change from baseline in total score at Week 12||||<0.0001
70942802|NCT00843115|141386087|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero||Change from baseline in total score at Week 12 Last Observation Carried Forward||||<0.0001
70942803|NCT00843115|141386088|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||correlation coefficient|P value tests whether Pearson Product Correlation Coefficient is significantly different from zero||||||<0.0001
70942804|NCT00843115|141386089|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||correlation coefficient|p-value tests whether Pearson Product Correlation Coefficient is significantly different from zero||||||<0.0001
70942805|NCT00843115|141386090|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero.||||||<0.0001
70942806|NCT00843115|141386091|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero||||||<0.0001
70942807|NCT00843115|141386092|SUPERIORITY_OR_OTHER|||||||0.0713|||||||correlation coefficient|||||||0.0713
70942808|NCT00843115|141386093|SUPERIORITY_OR_OTHER|||||||0.0225|||||||Correlation coefficient|||||||0.0225
70942809|NCT00843115|141386094|SUPERIORITY_OR_OTHER|||||||0.0152|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero.||||||0.0152
70942810|NCT00843115|141386095|SUPERIORITY_OR_OTHER|||||||0.0229|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero||||||0.0229
70942811|NCT00843115|141386096|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero.||||||<0.0001
71079895|NCT04227405|141667029|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Relationship Commitment subscale for the control group||||>.05
71079896|NCT04227405|141667029|SUPERIORITY||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Relationship Commitment subscale for the intervention group||||<.001
70854394|NCT03222492|141197256|SUPERIORITY|||||||0.25||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||0.250
70942812|NCT00843115|141386097|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero.||||||<0.0001
70942813|NCT00843115|141386098|SUPERIORITY_OR_OTHER|||||||0.7963|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12."||||||0.7963
70942814|NCT00843115|141386099|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12 LOCF."||||||1.0000
70942815|NCT00843115|141386100|SUPERIORITY_OR_OTHER|||||||0.0719|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12"||||||0.0719
71079897|NCT04227405|141667029|SUPERIORITY||Slope|0.27|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Relationship Commitment subscale||||<.001
71079898|NCT04227405|141667029|SUPERIORITY||Slope|-0.7|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Depression subscale for the control group||||<.001
71079899|NCT04227405|141667029|SUPERIORITY||Slope|-0.81|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|||||No adjustment in p value|Multilevel modeling|||Changes from pre-test to posttest in the Depression subscale for the control group|A positive value indicates an increase while a negative value indicates a decrease|||<.001
71079900|NCT04227405|141667029|SUPERIORITY||Slope|-0.11|STANDARD_ERROR_OF_MEAN|0.26|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Depression subscale||||>.05
71079901|NCT04227405|141667029|SUPERIORITY||Slope|-0.26|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Anxiety subscale for the control group||||>.05
71079902|NCT04227405|141667029|SUPERIORITY||Slope|-0.41|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Anxiety subscale for the intervention group||||<.001
71079903|NCT04227405|141667029|SUPERIORITY||Slope|-0.15|STANDARD_ERROR_OF_MEAN|0.16|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test and post-test in the intervention group were not significantly different from the change from pre-test and post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Anxiety subscale||||>.05
71079904|NCT04227405|141667029|SUPERIORITY||Slope|0.11|STANDARD_ERROR_OF_MEAN|0.04|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in Budgeting subscale for the control group||||<.05
71079905|NCT04227405|141667029|SUPERIORITY||Slope|0.23|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Budgeting subscale for the intervention group||||<.001
71079906|NCT04227405|141667029|SUPERIORITY||Slope|0.12|STANDARD_ERROR_OF_MEAN|0.05|<|0.1|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Budgeting subscale||||<.10
71079907|NCT04227405|141667029|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.05|<|0.1|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Difficulties to Pay Bills subscale for the control group||||<.10
71079908|NCT04227405|141667029|SUPERIORITY||Slope|-0.21|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Difficulties to Pay Bills subscale for the intervention group||||<.001
71079909|NCT04227405|141667029|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Post-test in the Difficulties to Pay Bills subscale|Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|||>.05
71079910|NCT04227405|141667029|SUPERIORITY||Slope|0.11|STANDARD_ERROR_OF_MEAN|0.11|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in Time with Partner subscale for the control group||||>.05
71079911|NCT04227405|141667029|SUPERIORITY||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.13|<|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in Time with Partner subscale for the intervention group||||<.05
71079912|NCT04227405|141667029|SUPERIORITY||Slope|0.16|STANDARD_ERROR_OF_MEAN|0.17|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to pos-test in the intervention group were not significantly different from the change from pre-test to pos-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in Time with Partner subscale||||>.05
70854395|NCT03222492|141197256|SUPERIORITY|||||||0.167||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||0.167
70942816|NCT00843115|141386101|SUPERIORITY_OR_OTHER|||||||0.1779|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12 LOCF."||||||0.1779
70942817|NCT00843115|141386102|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12"||||||1.0000
70942818|NCT00843115|141386103|SUPERIORITY_OR_OTHER|||||||0.8575|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12 LOCF"||||||0.8575
71079913|NCT04227405|141667029|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Positive values indicate an increase whereas a negative value indicates a decrease|Change from pre-test to post-test in banking subscale for control group||||>.05
70942819|NCT00843115|141386104|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12"||||||1.0000
70942820|NCT00843115|141386105|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12 LOCF"||||||1.0000
71079914|NCT04227405|141667029|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in banking subscale for the intervention group||||>.05
70942821|NCT00843115|141386106|SUPERIORITY_OR_OTHER|||||||0.0131|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12"||||||0.0131
70942822|NCT00843115|141386107|SUPERIORITY_OR_OTHER|||||||0.0078|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12 LOCF"||||||0.0078
70942823|NCT02621047|141386108|SUPERIORITY_OR_OTHER||Geometric Mean Ratio Percentage (%)|128.0|||||TWO_SIDED|90.0|86.5|188.0||||||||188|86.5|
70942824|NCT02621047|141386108|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|100.0|||||TWO_SIDED|90.0|55.1|183.0||||||||183|55.1|
70942825|NCT02621047|141386109|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|148.0|||||TWO_SIDED|90.0|106.0|208.0||||||||208|106|
70942826|NCT02621047|141386109|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|130.0|||||TWO_SIDED|90.0|75.4|225.0||||||||225|75.4|
70942827|NCT02621047|141386110|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|160.0||||||90.0|105.0|243.0||||||||243|105|
70942828|NCT02621047|141386110|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|220.0||||||90.0|131.0|369.0||||||||369|131|
70942829|NCT02621047|141386111|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|186.0||||||90.0|122.0|281.0||||||||281|122|
70942830|NCT02621047|141386111|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|285.0||||||90.0|175.0|466.0||||||||466|175|
70942831|NCT02621047|141386112|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|162.0|||||TWO_SIDED|90.0|104.0|254.0||||||||254|104|
70942832|NCT02621047|141386112|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|228.0||||||90.0|129.0|403.0||||||||403|129|
70942833|NCT02621047|141386113|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|189.0||||||90.0|121.0|293.0||||||||293|121|
70942834|NCT02621047|141386113|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|296.0|||||TWO_SIDED|90.0|174.0|506.0||||||||506|174|
70942835|NCT02621047|141386114|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|64.6||||||90.0|36.2|115.0||||||||115|36.2|
70942836|NCT02621047|141386114|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|60.8|||||TWO_SIDED|90.0|26.6|139.0||||||||139|26.6|
70942837|NCT02621047|141386115|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|85.1||||||90.0|55.5|130.0||||||||130|55.5|
70942838|NCT02621047|141386115|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|59.0||||||90.0|34.2|102.0||||||||102|34.2|
71118160|NCT03389555|141741093|EQUIVALENCE|If the adjusted risk difference from the logistic regression analysis overlaps 0, there was considered to be no difference between groups|Risk Difference (RD)|3.0||||0.55|TWO_SIDED|95.0|-10.0|20.0|||Regression, Logistic|||Logistic regression analysis evaluating the key secondary outcome of hospital mortality in treatment group (intervention versus placebo) controlling for treatment site..||20.0|-10.0|0.55
71118161|NCT03389555|141741094|EQUIVALENCE|If the adjusted risk difference from the logistic regression analysis overlaps 0, there was considered to be no difference between groups|Risk Difference (RD)|2.0||||0.8|TWO_SIDED|95.0|-10.0|10.0|||Regression, Logistic|||Logistic regression analysis evaluating the key secondary outcome of ICU mortality in treatment group (intervention versus placebo) controlling for treatment site.||10.0|-10.0|0.80
70942839|NCT02621047|141386116|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|116.0||||||90.0|78.6|172.0||||||||172|78.6|
70942840|NCT02621047|141386116|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|98.1||||||90.0|51.7|186.0||||||||186|51.7|
70942841|NCT02621047|141386117|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|115.0|||||TWO_SIDED|90.0|85.2|154.0||||||||154|85.2|
70942842|NCT02621047|141386117|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|96.6|||||TWO_SIDED|90.0|55.6|168.0||||||||168|55.6|
70942843|NCT02621047|141386118|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|80.6||||||90.0|50.2|130.0||||||||130|50.2|
70942844|NCT02621047|141386118|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|65.6|||||TWO_SIDED|90.0|26.9|160.0||||||||160|26.9|
70942845|NCT02621047|141386119|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|104.0||||||90.0|76.8|141.0||||||||141|76.8|
70942846|NCT02621047|141386119|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|63.7|||||TWO_SIDED|90.0|34.0|119.0||||||||119|34.0|
70942847|NCT02621047|141386120|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|136.0|||||TWO_SIDED|90.0|94.7|196.0||||||||196|94.7|
70942848|NCT02621047|141386120|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|176.0||||||90.0|98.4|315.0||||||||315|98.4|
70942849|NCT02621047|141386121|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|134.0||||||90.0|99.6|181.0||||||||181|99.6|
70942850|NCT02621047|141386121|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|157.0|||||TWO_SIDED|90.0|91.8|268.0||||||||268|91.8|
70942851|NCT02621047|141386122|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|73.3|||||TWO_SIDED|90.0|46.2|116.0||||||||116|46.2|
70942852|NCT02621047|141386122|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|57.5|||||TWO_SIDED|90.0|20.0|165.0||||||||165|20.0|
70942853|NCT02621047|141386123|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|96.6||||||90.0|69.9|134.0||||||||134|69.9|
70942854|NCT02621047|141386123|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|55.8||||||90.0|26.0|120.0||||||||120|26.0|
70942855|NCT02621047|141386124|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|139.0|||||TWO_SIDED|90.0|94.8|203.0||||||||203|94.8|
70942856|NCT02621047|141386124|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|180.0||||||90.0|97.2|334.0||||||||334|97.2|
70942857|NCT02621047|141386125|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|137.0|||||TWO_SIDED|90.0|100.0|186.0||||||||186|100|
70942858|NCT02621047|141386125|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|158.0|||||TWO_SIDED|90.0|91.2|274.0||||||||274|91.2|
70942859|NCT01951261|141386135|NON_INFERIORITY|sample size calculation was made, considering it appropriate to set a limit of non-inferiority with respect to the main variable of 1.2 months (36 days), the study being lower if it will have exacerbation before this period of time, with a follow-up of 6 months, It was required to include a sample of 58 patients per group for a potency of 80% and a significance level of 5%.|||||<|0.05||||||The reported p-value was calculated.Statistical analysis of the main variable was performed using the Kaplan-Meier method and log-rank test|Log Rank|||||||<0.05
70942860|NCT03740919|141386170|NON_INFERIORITY|Noninferiority margin \[NIM\]=0.4% for HbA1c|Least Squares (LS) Mean Difference|-0.02||||0.783|TWO_SIDED|95.0|-0.17|0.13|||Mixed Models Analysis|||||0.13|-0.17|0.783
70942861|NCT03740919|141386171|NON_INFERIORITY|NIM of 0.4%|LS Mean Difference|-0.02||||0.867|TWO_SIDED|95.0|-0.2|0.17|||Mixed Models Analysis|||||0.17|-0.20|0.867
70942862|NCT03740919|141386172|SUPERIORITY||Odds Ratio (OR)|1.61||||0.008|TWO_SIDED|95.0|1.13|2.3|||Regression, Logistic|||\< 54 mg/dL 1 hour post-dose||2.30|1.13|0.008
70942863|NCT03740919|141386172|SUPERIORITY||Odds Ratio (OR)|1.17||||0.487|TWO_SIDED|95.0|0.75|1.83|||Regression, Logistic|||\< 54 mg/dL 1 hour post-dose||1.83|0.75|0.487
70942864|NCT03740919|141386172|SUPERIORITY||Odds Ratio (OR)|0.73||||0.153|TWO_SIDED|95.0|0.47|1.13|||Regression, Logistic|||\< 54 mg/dL 1 hour post-dose||1.13|0.47|0.153
70942865|NCT03740919|141386172|SUPERIORITY||Odds Ratio (OR)|1.49||||0.02|TWO_SIDED|95.0|1.06|2.08|||Regression, Logistic|||\< 54 mg/dL 2 hour post-dose||2.08|1.06|0.020
70942866|NCT03740919|141386172|SUPERIORITY||Odds Ratio (OR)|1.17||||0.455|TWO_SIDED|95.0|0.78|1.76|||Regression, Logistic|||\< 54 mg/dL 2 hour post-dose||1.76|0.78|0.455
70942867|NCT03740919|141386172|SUPERIORITY||Odds Ratio (OR)|0.79||||0.259|TWO_SIDED|95.0|0.52|1.19|||Regression, Logistic|||\< 54 mg/dL 2 hour post-dose||1.19|0.52|0.259
70942868|NCT03740919|141386172|SUPERIORITY||Odds Ratio (OR)|1.79|||<|0.001|TWO_SIDED|95.0|1.29|2.51|||Regression, Logistic|||≤ 70 mg/dL 1 hour post-dose||2.51|1.29|<0.001
70942869|NCT03740919|141386172|SUPERIORITY||Odds Ratio (OR)|0.95||||0.822|TWO_SIDED|95.0|0.64|1.43|||Regression, Logistic|||≤ 70 mg/dL 1 hour post-dose||1.43|0.64|0.822
70942870|NCT03740919|141386172|SUPERIORITY||Odds Ratio (OR)|0.53||||0.003|TWO_SIDED|95.0|0.35|0.8|||Regression, Logistic|||≤ 70 mg/dL 1 hour post-dose||0.80|0.35|0.003
70942871|NCT03740919|141386172|SUPERIORITY||Odds Ratio (OR)|1.42||||0.092|TWO_SIDED|95.0|0.94|2.14|||Regression, Logistic|||≤ 70 mg/dL 2 hour post-dose||2.14|0.94|0.092
70942872|NCT03740919|141386172|SUPERIORITY||Odds Ratio (OR)|0.71||||0.133|TWO_SIDED|95.0|0.45|1.11|||Regression, Logistic|||≤ 70 mg/dL 2 hour post-dose||1.11|0.45|0.133
71079915|NCT04227405|141667029|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Post-test in Banking subscale|Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to pos-test in the control group|||>.05
70942873|NCT03740919|141386172|SUPERIORITY||Odds Ratio (OR)|0.5||||0.004|TWO_SIDED|95.0|0.31|0.8|||Regression, Logistic|||≤ 70 mg/dL 2 hour post-dose||0.80|0.31|0.004
70942874|NCT03740919|141386173|SUPERIORITY|||||||0.22|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||\< 54 mg/dL 1 hour post-dose||||0.220
70942875|NCT03740919|141386173|SUPERIORITY|||||||0.599|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||\< 54 mg/dL 1 hour post-dose||||0.599
70942876|NCT03740919|141386173|SUPERIORITY|||||||0.112|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||\< 54 mg/dL 1 hour post-dose||||0.112
70942877|NCT03740919|141386173|SUPERIORITY|||||||0.034|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||\< 54 mg/dL 2 hour post-dose||||0.034
70942878|NCT03740919|141386173|SUPERIORITY|||||||0.055|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||\< 54 mg/dL 2 hour post-dose||||0.055
70942879|NCT03740919|141386173|SUPERIORITY|||||||0.814|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||\< 54 mg/dL 2 hour post-dose||||0.814
70942880|NCT03740919|141386173|SUPERIORITY|||||||0.194|||||||Negative binomial regression|||≤70 mg/dL 1 hour post-dose||||0.194
70942881|NCT03740919|141386173|SUPERIORITY|||||||0.428|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||≤70 mg/dL 1 hour post-dose||||0.428
70942882|NCT03740919|141386173|SUPERIORITY|||||||0.057|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||≤70 mg/dL 1 hour post-dose||||0.057
70942883|NCT03740919|141386173|SUPERIORITY|||||||0.056|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model||≤70 mg/dL 2 hour post-dose||||0.056
70942884|NCT03740919|141386173|SUPERIORITY|||||||0.435|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||≤70 mg/dL 2 hour post-dose||||0.435
70942885|NCT03740919|141386173|SUPERIORITY|||||||0.404|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||≤70 mg/dL 2 hour post-dose||||0.404
70942886|NCT03740919|141386174|SUPERIORITY||Odds Ratio (OR)|1.04||||0.864|TWO_SIDED|95.0|0.68|1.57|||Regression, Logistic|||\<54 mg/dL||1.57|0.68|0.864
70942887|NCT03740919|141386174|SUPERIORITY||Odds Ratio (OR)|0.69||||0.132|TWO_SIDED|95.0|0.43|1.12|||Regression, Logistic|||\<54 mg/dL||1.12|0.43|0.132
71118162|NCT03389555|141741095|EQUIVALENCE|If the adjusted risk difference from the logistic regression analysis overlaps 0, there was considered to be no difference between groups|Risk Difference (RD)|-12.0||||0.16|TWO_SIDED|95.0|-25.0|4.0|||Regression, Logistic|||Logistic regression analysis evaluating the key secondary outcome of occurrence of delirium in treatment group (intervention versus placebo) controlling for treatment site.||4|-25|0.16
70942888|NCT03740919|141386174|SUPERIORITY||Odds Ratio (OR)|0.67||||0.104|TWO_SIDED|95.0|0.41|1.09|||Regression, Logistic|||||1.09|0.41|0.104
70942889|NCT03740919|141386174|SUPERIORITY||Odds Ratio (OR)|0.8||||0.489|TWO_SIDED|95.0|0.42|1.52|||Regression, Logistic|||≤70 mg/dL||1.52|0.42|0.489
70942890|NCT03740919|141386174|SUPERIORITY||Odds Ratio (OR)|0.45||||0.025|TWO_SIDED|95.0|0.23|0.9|||Regression, Logistic|||≤70 mg/dL||0.90|0.23|0.025
70942891|NCT03740919|141386174|SUPERIORITY||Odds Ratio (OR)|0.57||||0.099|TWO_SIDED|95.0|0.29|1.11|||Regression, Logistic|||≤70 mg/dL||1.11|0.29|0.099
70942892|NCT03740919|141386175|SUPERIORITY|||||||0.732|||||||Negative binomial regression|||\< 54 mg/dL||||0.732
70942893|NCT03740919|141386175|SUPERIORITY|||||||0.638|||||||Negative binomial regression|||\< 54 mg/dL||||0.638
70942894|NCT03740919|141386175|SUPERIORITY|||||||0.462|||||||Negative binomial regression|||\<54 mg/dL||||0.462
70942895|NCT03740919|141386175|SUPERIORITY|||||||0.632|||||||Negative binomial regression|||≤ 70 mg/dL||||0.632
70942896|NCT03740919|141386175|SUPERIORITY|||||||0.8|||||||Negative binomial regression|||≤ 70 mg/dL||||0.800
70942897|NCT03740919|141386175|SUPERIORITY|||||||0.889|||||||Negative binomial regression|||≤ 70 mg/dL||||0.889
70942898|NCT03740919|141386177|SUPERIORITY||LS Mean Difference|0.6||||0.13|TWO_SIDED|95.0|-0.2|1.4|||Mixed Models Analysis|||Total Daily Basal Insulin||1.4|-0.2|0.130
70942899|NCT03740919|141386177|SUPERIORITY||LS Mean Difference|0.4||||0.404|TWO_SIDED|95.0|-0.5|1.4|||Mixed Models Analysis|||Total Daily Basal Insulin||1.4|-0.5|0.404
70854396|NCT03222492|141197256|SUPERIORITY|||||||0.083||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 36||||0.083
70942900|NCT03740919|141386177|SUPERIORITY||LS Mean Difference|-0.2||||0.693|TWO_SIDED|95.0|-1.2|0.8|||Mixed Models Analysis|||Total Daily Basal Insulin||0.8|-1.2|0.693
70942901|NCT03740919|141386177|SUPERIORITY||LS Mean Difference|0.5||||0.625|TWO_SIDED|95.0|-1.4|2.3|||Mixed Models Analysis|||Total Daily Insulin Dose||2.3|-1.4|0.625
70942902|NCT03740919|141386177|SUPERIORITY||LS Mean Difference|-0.4||||0.758|TWO_SIDED|95.0|-2.6|1.9|||Mixed Models Analysis|||Total Daily Insulin Dose||1.9|-2.6|0.758
70942903|NCT03740919|141386177|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.485|TWO_SIDED|95.0|-3.1|1.5|||Mixed Models Analysis|||Total Daily Insulin Dose||1.5|-3.1|0.485
70942904|NCT03740919|141386178|SUPERIORITY||Odds Ratio (OR)|1.23||||0.396|TWO_SIDED|95.0|0.76|2.0|||Regression, Logistic|||HbA1c \< 7%||2.00|0.76|0.396
70942905|NCT03740919|141386178|SUPERIORITY||Odds Ratio (OR)|0.93||||0.814|TWO_SIDED|95.0|0.49|1.75|||Regression, Logistic|||HbA1c \< 7%||1.75|0.49|0.814
70942906|NCT03740919|141386178|SUPERIORITY||Odds Ratio (OR)|0.75||||0.384|TWO_SIDED|95.0|0.39|1.43|||Regression, Logistic|||HbA1c \< 7%||1.43|0.39|0.384
71118163|NCT03389555|141741096|EQUIVALENCE|If the adjusted risk difference from the logistic regression analysis overlaps 0, there was considered to be no difference between groups|Risk Difference (RD)|-1.8||||0.82|TWO_SIDED|95.0|-18.0|14.0|||Regression, Logistic|||Logistic regression analysis evaluating home hospital disposition in survivors to hospital discharge in intervention versus placebo group controlling for treatment site.||14|-18|0.82
71118164|NCT00920218|141741117|SUPERIORITY|Criterion for superiority: The Lower Limit (LL) of the Confidence Interval (CI) of the ratio of geometric means, in terms of ceellular immune (CMI) response for GSK 1437173A F1 Group as compared to Placebo Group, is above (\>) 2.|Fold increase over Control|32.31|||<|0.0001|TWO_SIDED|76.16|20.65|50.54|||Dunnett for multiple comparisons|||The null hypothesis was H0: GSK 1437173A F1 Group/Placebo Group below (\<) 1.||50.54|20.65|<0.0001
71118165|NCT00920218|141741117|SUPERIORITY|Criterion for superiority: The Lower Limit (LL) of the Confidence Interval (CI) of the ratio of geometric means, in terms of CMI response for Placebo-GSK 1437173A F1 Group as compared to Placebo Group, is above (\>) 2.|Fold increase over Control|9.51|||<|0.0001|TWO_SIDED|76.16|6.07|14.9|||Dunnett for multiple comparisons|||The null hypothesis was H0: Placebo-GSK 1437173A F1 Group/Placebo Group \< 2.||14.9|6.07|<0.0001
71118166|NCT00920218|141741118|SUPERIORITY|Criterion for superiority: The Lower Limit (LL) of the Confidence Interval (CI) of the ratio of geometric means, in terms of humoral response for GSK 1437173A F1 Group as compared to Placebo Group, is above (\>) 3.|Fold increase over Control|74.41|||<|0.0001|TWO_SIDED|76.16|33.12|167.17|||Dunnett for multiple comparisons|||The null hypothesis was H0: GSK 1437173A 1 Group/Placebo Group \< 1.||167.17|33.12|<0.0001
71118167|NCT00920218|141741118|SUPERIORITY|Criterion for superiority: The Lower Limit (LL) of the Confidence Interval (CI) of the ratio of geometric means, in terms of humoral response for Placebo-GSK 1437173A F1 Group as compared to Placebo Group, is above (\>) 3.|Fold increase over Control|42.2|||<|0.0001|TWO_SIDED|76.16|20.2|88.13|||Dunnett for multiple comparisons|||The null hypothesis was H0: Placebo-GSK 1437173A 1 Group/Placebo Group \< 1.||88.13|20.20|<0.0001
71118168|NCT01007435|141741148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.77|||<|0.0001|TWO_SIDED|95.0|3.19|7.14||A hierarchy of statistical testing was implemented in order to control the type I error rate for multiple comparisons.|Regression, Logistic|The stratification factors, region and serologic status, were included in the model.|"Last observation carried forward was used for TJC and SJC. No imputation was used for ESR and GH. Patients who withdrew prematurely or where a DAS28 could not be calculated were set to non-responder."|The null hypothesis is that there is no difference in the DAS28 remission response at Week 24 between the placebo to tocilizumab + methotrexate and the tocilizumab 8 mg/kg + methotrexate treatment groups.||7.14|3.19|<0.0001
71118169|NCT01007435|141741148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.7|||<|0.0001|TWO_SIDED|95.0|2.47|5.55||A hierarchy of statistical testing was implemented in order to control the type I error rate for multiple comparisons.|Regression, Logistic|The stratification factors, region and serologic status, were included in the model.|"Last observation carried forward was used for TJC and SJC. No imputation was used for ESR and GH. Patients who withdrew prematurely or where a DAS28 could not be calculated were set to non-responder."|The null hypothesis is that there is no difference in the DAS28 remission response at Week 24 between the placebo to tocilizumab + methotrexate and the tocilizumab 8 mg/kg + placebo to methotrexate treatment groups.||5.55|2.47|<0.0001
71118170|NCT01007435|141741148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.72|||<|0.0001|TWO_SIDED|95.0|1.8|4.11||A hierarchy of statistical testing was implemented in order to control the type I error rate for multiple comparisons. This comparison came after the break in statistical hierarchy.|Regression, Logistic|The stratification factors, region and serologic status, were included in the model.|"Last observation carried forward was used for TJC and SJC. No imputation was used for ESR and GH. Patients who withdrew prematurely or where a DAS28 could not be calculated were set to non-responder."|The null hypothesis is that there is no difference in the DAS28 remission response at Week 24 between the placebo to tocilizumab + methotrexate and the tocilizumab 4 mg/kg + methotrexate treatment groups.||4.11|1.80|<0.0001
71118171|NCT02163967|141741162|OTHER||||||<|0.02||||||Mixed effects regression model, a nested (within subject) random intercept for dose, fixed effects for age, dose, time and dose x time interaction. Significance level p=.05, Bonferonni correction was used for post-hoc tests.|Regression, Linear|Post-hoc comparisons using least-square means. Kenward-Roger adjustments to denominator degrees of freedom.Increase in HRV at 2Amp compared to sham.||The null hypothesis is that there is no difference in High frequency HRV after 20 minutes of stimulation or 15 minutes after cessation of stimulation at the low (1mAmp) or high (2mAmp) dose compared to sham stimulation||||<.02
71118172|NCT02163967|141741163|OTHER||||||<|0.001|||||||Chi-squared|||The null hypothesis is that there will be no difference in the number of side effects reported during either dose of stimulation compared to sham stimulation. Statistical differences were examined for light flickering in peripheral vision . Other side effects were reported by too few subjects to be analyzed statistically.||||<.001
71079916|NCT04227405|141667029|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in parenting stress subscale for the control group||||>.05
71079917|NCT04227405|141667029|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in parenting stress subscale for the intervention group||||>.05
71079918|NCT04227405|141667029|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.11|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to pos-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in Parenting stresss subscale||||>.05
71079919|NCT04227405|141667029|SUPERIORITY||Slope|0.14|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in conflict management satisfaction subscale for the control group||||<.001
71079920|NCT04227405|141667029|SUPERIORITY||Slope|0.32|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in conflict management satisfaction subscale for the intervention group||||<.001
71079921|NCT04227405|141667029|SUPERIORITY||Slope|0.19|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||The increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in Conflict Management Satisfaction subscale||||<.001
71079922|NCT04227405|141667030|SUPERIORITY||Slope|0.18|STANDARD_ERROR_OF_MEAN|0.28|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Positive Conflict Management subscale for the control group||||>.05
71079923|NCT04227405|141667030|SUPERIORITY||Slope|1.53|STANDARD_ERROR_OF_MEAN|0.35|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Positive Conflict Management subscale for the intervention group||||<.001
71079924|NCT04227405|141667030|SUPERIORITY||Slope|1.35|STANDARD_ERROR_OF_MEAN|0.44|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Positive Conflict Management subscale|Difference between the control and the intervention group in the change from Pre-test to Follow-up n the Positive Conflict Management subscale||||<.01
71079925|NCT04227405|141667030|SUPERIORITY||Slope|-0.41|STANDARD_ERROR_OF_MEAN|0.28|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Negative Conflict subscale for the control group||||>.05
71079926|NCT04227405|141667030|SUPERIORITY||Slope|-1.4|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Changes from pre-test to Follow-up in the Negative Conflict Manageement subscale for the intervention group|A positive value indicates an increase while a negative value indicates a decrease|||<.001
71079927|NCT04227405|141667030|SUPERIORITY||Slope|-0.99|STANDARD_ERROR_OF_MEAN|0.44|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected decrease from pre-test to follow-i\[in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up n the Negative Conflict Management subscale||||<.01
71079928|NCT04227405|141667030|SUPERIORITY||Slope|0.41|STANDARD_ERROR_OF_MEAN|0.17|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Relationship Quality subscale for the control group||||>.05
71118173|NCT02163967|141741164|OTHER|||||||0.81||||||Mixed effects regression model, a nested (within subject) random intercept for dose, fixed effects for age, dose, time and dose x time interaction. Significance level p=.05, Bonferonni correction was used for post-hoc tests.|Regression, Linear|Post-hoc comparisons were made using least-square means. Kenward-Roger adjustments to denominator degrees of freedom.||||||0.81
70942907|NCT03740919|141386178|SUPERIORITY||Odds Ratio (OR)|0.84||||0.4|TWO_SIDED|95.0|0.55|1.27|||Regression, Logistic|||HbA1c \< 7.5%||1.27|0.55|0.400
70942908|NCT03740919|141386178|SUPERIORITY||Odds Ratio (OR)|0.62||||0.094|TWO_SIDED|95.0|0.36|1.08|||Regression, Logistic|||HbA1c \< 7.5%||1.08|0.36|0.094
70942909|NCT03740919|141386178|SUPERIORITY||Odds Ratio (OR)|0.75||||0.306|TWO_SIDED|95.0|0.43|1.31|||Regression, Logistic|||HbA1c \< 7.5%||1.31|0.43|0.306
70942910|NCT03640754|141386181|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
70942911|NCT03640754|141386181|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
70942912|NCT03640754|141386182|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
70942913|NCT03640754|141386182|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
70854397|NCT03222492|141197256|SUPERIORITY|||||||0.083||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||0.083
70942914|NCT03640754|141386183|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
70854398|NCT03222492|141197257|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||1.000
70942915|NCT03640754|141386183|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
70942916|NCT03640754|141386184|SUPERIORITY|||||||0.199|||||||t-test, 1 sided|||||||0.199
70942917|NCT03640754|141386184|SUPERIORITY|||||||0.189|||||||t-test, 1 sided|||||||0.189
70942918|NCT03640754|141386185|SUPERIORITY|Least squares means (LS Means) from a mixed effects repeated measures model with baseline M+S score, current smoking status, bmi, and parity as covariates||||||0.398|||||||Mixed Models Analysis|||||||0.398
70942919|NCT03640754|141386185|SUPERIORITY|Least squares means (LS Means) from a mixed effects repeated measures model with baseline M+S score, current smoking status, bmi, and parity as covariates||||||0.391|||||||Mixed Models Analysis|||||||0.391
70942920|NCT03640754|141386186|SUPERIORITY|||||||0.232|||||||Mixed Models Analysis|||Least squares means (LS Means) from a mixed effects repeated measures model with baseline M+S score, current smoking status, bmi, and parity as covariates||||0.232
70942921|NCT03640754|141386186|SUPERIORITY|||||||0.085|||||||Mixed Models Analysis|||Least squares means (LS Means) from a mixed effects repeated measures model with baseline M+S score, current smoking status, bmi, and parity as covariates||||0.085
70942922|NCT03640754|141386187|SUPERIORITY|||||||0.501|||||||Mixed Models Analysis|||||||0.501
70942923|NCT03640754|141386187|SUPERIORITY|||||||0.37|||||||Mixed Models Analysis|||||||0.370
70942924|NCT03640754|141386188|SUPERIORITY|||||||0.333|||||||Mixed Models Analysis|||||||0.333
70942925|NCT03640754|141386188|SUPERIORITY|||||||0.014|||||||Mixed Models Analysis|||||||0.014
70942926|NCT03640754|141386189|SUPERIORITY|||||||0.124|||||||Mixed Models Analysis|||||||0.124
70942927|NCT03640754|141386189|SUPERIORITY|||||||0.175|||||||Mixed Models Analysis|||||||0.175
70942928|NCT03640754|141386190|SUPERIORITY|||||||0.032|||||||Mixed Models Analysis|||||||0.032
70942929|NCT03640754|141386190|SUPERIORITY|||||||0.077|||||||Mixed Models Analysis|||||||0.077
70942930|NCT03640754|141386194|SUPERIORITY|||||||0.047|||||||t-test, 1 sided|||||||0.047
70942931|NCT03640754|141386194|SUPERIORITY|||||||0.139|||||||t-test, 1 sided|||||||0.139
70942932|NCT03640754|141386194|SUPERIORITY|||||||0.395|||||||t-test, 1 sided|||||||0.395
70942933|NCT03640754|141386195|SUPERIORITY|||||||0.147|||||||t-test, 1 sided|||||||0.147
70942934|NCT03640754|141386195|SUPERIORITY|||||||0.16|||||||t-test, 1 sided|||||||0.160
70942935|NCT03640754|141386195|SUPERIORITY|||||||0.152|||||||t-test, 1 sided|||||||0.152
70942936|NCT03640754|141386196|SUPERIORITY|||||||0.286|||||||t-test, 1 sided|||||||0.286
70942937|NCT03640754|141386196|SUPERIORITY|||||||0.107|||||||t-test, 1 sided|||||||0.107
70942938|NCT03640754|141386197|SUPERIORITY|||||||0.289|||||||t-test, 1 sided|||||||0.289
70942939|NCT03640754|141386197|SUPERIORITY|||||||0.338|||||||t-test, 1 sided|||||||0.338
70942940|NCT03640754|141386198|SUPERIORITY|||||||0.393|||||||t-test, 1 sided|||||||0.393
70942941|NCT03640754|141386198|SUPERIORITY|||||||0.365|||||||t-test, 1 sided|||||||0.365
70942942|NCT03640754|141386199|SUPERIORITY|||||||0.406|||||||t-test, 1 sided|||||||0.406
70942943|NCT03640754|141386199|SUPERIORITY|||||||0.494|||||||t-test, 1 sided|||||||0.494
70942944|NCT05329402|141386200|NON_INFERIORITY|"The non-inferiority hypothesis is tenable if the lower limit of 95% confidence interval of the difference in the primary effectiveness evaluation indicator device cutting and anastomosis success rate between the test group and the control group is greater than the non-inferiority critical value (-10%)."|Mean Difference (Final Values)|0.0||||0.9727|TWO_SIDED|95.0|-0.0285|0.0273|||Wald|||||0.0273|-0.0285|0.9727
70942945|NCT01679613|141386204|SUPERIORITY_OR_OTHER||Geometric Mean Ratio in percentage|160.48|STANDARD_DEVIATION|17.9||1|TWO_SIDED|90.0|148.245|173.736||p-value for ratio outside interval 0.8 - 1.25|ANOVA|The model includes fixed effects for sequence, period, and treatment. Subjects within sequences is included as random effect.|"Ratio calculated as nintedanib+ketoconazole divided by nintedanib (in %).~The standard deviation is actually the geometric coefficient of variation (gCV)."|||173.736|148.245|1.0000
70942946|NCT01679613|141386205|SUPERIORITY_OR_OTHER||Geometric Mean Ratio in percentage|179.62|STANDARD_DEVIATION|29.9||1|TWO_SIDED|90.0|157.557|204.779||p-value for ratio outside interval 0.8 - 1.25|ANOVA|The model includes fixed effects for sequence, period, and treatment. Subjects within sequences is included as random effect.|"The standard deviation is actually the gCV (in %).~Ratio calculated as nintedanib+ketoconazole divided by nintedanib"|||204.779|157.557|1.0000
70942947|NCT01679613|141386206|SUPERIORITY_OR_OTHER||Geometric Mean Ratio in percentage|168.09|STANDARD_DEVIATION|17.9||1|TWO_SIDED|90.0|155.252|181.981||p-value for ratio outside interval 0.8 to 1.25|ANOVA|The model includes fixed effects for sequence, period, and treatment. Subjects within sequences is included as random effect.|"The standard deviation is actually the gCV.~Ratio calculated as nintedanib+ketoconazole divided by nintedanib (in %)."|||181.981|155.252|1.000
70942948|NCT04783519|141386207|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-0.39||||0.004|TWO_SIDED|95.0|-0.65|-0.127|||Regression, Linear|Models control for age, sex, race, and ethnicity.||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||-0.127|-0.650|.004
70942949|NCT04783519|141386207|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-0.21||||0.118|TWO_SIDED|95.0|-0.482|0.054|||Regression, Linear|Models control for age, sex, race, and ethnicity.||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||.054|-.482|.118
70942950|NCT04783519|141386207|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-0.41||||0.003|TWO_SIDED|95.0|-0.674|-0.142|||Regression, Linear|Models control for age, sex, race, and ethnicity.||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||-0.142|-0.674|.003
71118174|NCT02163967|141741165|OTHER|||||||0.47||||||Mixed effects regression model, a nested (within subject) random intercept for dose, fixed effects for age, dose, time and dose x time interaction. Significance level p=.05, Bonferonni correction was used for post-hoc tests.|Regression, Linear|Post-hoc comparisons were made using least-square means. Kenward-Roger adjustments to denominator degrees of freedom.||||||0.47
71118175|NCT01425359|141741219|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||Angina frequency was compared by fitting a generalized linear model with log link and negative binomial distribution response.|Generalized linear model|||||||0.008
71118176|NCT01425359|141741220|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||Sublingual nitroglycerin use frequency was compared by fitting a generalized linear model with log link and negative binomial distribution response.|Generalized linear model|||||||0.003
71118177|NCT03520348|141741230|NON_INFERIORITY|It is considered less than 20% of differences between groups to consider non-inferiority||||||0.285|||||||Wilcoxon (Mann-Whitney)|||||||0.285
70942951|NCT04783519|141386207|SUPERIORITY||beta coefficient|-0.16||||0.24|TWO_SIDED|95.0|-0.428|0.107|||Regression, Linear|Models control for age, sex, race, and ethnicity.||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||0.107|-0.428|.240
70954218|NCT00688870|141411074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|93.8|||||TWO_SIDED|95.0|86.0|97.9|||Chan and Zhang|||Additional serotypes - serotype 7F||97.9|86.0|
71118178|NCT03520348|141741231|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.680
71118179|NCT03520348|141741232|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.839|||||||Wilcoxon (Mann-Whitney)|||||||0.839
71118180|NCT03520348|141741233|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.137|||||||Wilcoxon (Mann-Whitney)|||||||0.137
71118181|NCT03520348|141741235|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.667|||||||Chi-squared, Corrected|||||||0.667
71118182|NCT03520348|141741236|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.561|||||||Chi-squared, Corrected|||||||0.561
71118183|NCT03520348|141741237|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||1|||||||Chi-squared|||||||1.000
71118184|NCT03520348|141741238|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.317|||||||Chi-squared, Corrected|||||||0.317
71118185|NCT03520348|141741239|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.414|||||||Chi-squared, Corrected|||||||0.414
71118186|NCT02292758|141741240|SUPERIORITY||Hazard Ratio (HR)|0.912||||0.7609|TWO_SIDED|95.0|0.431|1.93|||Log Rank||Unadjusted HR; Model stratified by: prior bevacizumab (Y vs N) and prior lines of chemotherapy (1 vs 2+)|||1.930|0.431|0.7609
71118187|NCT02292758|141741240|SUPERIORITY||Hazard Ratio (HR)|0.642|||||TWO_SIDED|95.0|0.249|1.656|||||Adjusted HR; Model adjusted by: age, gender, race (white vs others), number of metastatic sites (1 vs 2 vs 3+), ECOG PS (0 vs 1), tumor site (colon, rectum/rectosigmoid, multiple)|||1.656|0.249|
71118188|NCT02292758|141741243|SUPERIORITY||Hazard Ratio (HR)|0.471||||0.0446|TWO_SIDED|95.0|0.209|1.062|||Log Rank||Unadjusted HR; Model stratified by: prior bevacizumab (Y vs N) and prior lines of chemotherapy (1 vs 2+)|||1.062|0.209|0.0446
71118189|NCT02292758|141741243|SUPERIORITY||Hazard Ratio (HR)|0.406|||||TWO_SIDED|95.0|0.151|1.089|||||Adjusted HR; Model adjusted by: age, gender, race (white vs others), number of metastatic sites (1 vs 2 vs 3+), ECOG PS (0 vs 1), tumor site (colon, rectum/rectosigmoid, multiple)|||1.089|0.151|
71118190|NCT02292758|141741245|SUPERIORITY|||||||0.3415|||||||Chi-squared|||||||0.3415
71118191|NCT02292758|141741246|SUPERIORITY|||||||0.1279|||||||Fisher Exact|||||||0.1279
71118192|NCT02292758|141741247|SUPERIORITY|||||||0.447|||||||Log Rank|||||||0.447
70942952|NCT04783519|141386208|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-4.88||||0.003|TWO_SIDED|95.0|-8.1|-1.65|||Regression, Linear|Models control for age, sex, race, and ethnicity.||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||-1.65|-8.10|.003
70942953|NCT04783519|141386208|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-1.71||||0.308|TWO_SIDED|95.0|-4.98|1.57|||Regression, Linear|Models control for age, sex, race, and ethnicity.||"Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.~Score on measure (T-score method https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3261577/)"||1.57|-4.98|.308
70954219|NCT00688870|141411074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|1.2|||||TWO_SIDED|95.0|-3.4|6.5|||Chan and Zhang|||Additional serotypes - serotype 19A||6.5|-3.4|
71118193|NCT02292758|141741248|SUPERIORITY||Hazard Ratio (HR)|0.755||||0.3738|TWO_SIDED|95.0|0.345|1.655|||Log Rank||Unadjusted HR; Model stratified by: prior bevacizumab (Y vs N) and prior lines of chemotherapy (1 vs 2+)|||1.655|0.345|0.3738
71118194|NCT02292758|141741249|SUPERIORITY|||||||0.4283|||||||Wilcoxon (Mann-Whitney)|||Cetuximab comparison||||0.4283
71118195|NCT02292758|141741249|SUPERIORITY|||||||0.5262|||||||Wilcoxon (Mann-Whitney)|||Irinotecan comparison||||0.5262
71118196|NCT00075946|141741304|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3||||0.33|TWO_SIDED|95.0|0.9|1.88|||Log Rank||Hazard ratio is for Rituximab Retreatment Arm/Rituximab Scheduled Arm in follicular patients.|The primary analysis is to compare the time to rituximab failure (TTRF) between the retreatment arm and the scheduled arm in follicular patients.||1.88|0.90|0.33
71118197|NCT00075946|141741304|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.75||||0.012|TWO_SIDED|95.0|1.22|6.19|||Log Rank||Hazard ratio is for Rituximab Retreatment Arm/Rituximab Scheduled Arm in non-follicular patients.|||6.19|1.22|0.012
71118198|NCT00075946|141741305|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|3.21||||0.002|TWO_SIDED|95.0|1.45|7.13|||Log Rank||Hazard ratio is for Rituximab Retreatment Arm/Rituximab Scheduled Arm in follicular patients.|||7.13|1.45|0.002
71118199|NCT00075946|141741305|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|TWO_SIDED||||||Log Rank|||||||0.0002
71118200|NCT00075946|141741306|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27|TWO_SIDED||||||t-test, 2 sided|||||||0.270
71118201|NCT03639623|141741313|OTHER|||||||0.053|||||||paired t-test|||||||0.053
71118202|NCT03639623|141741314|OTHER|||||||0.958|||||||paired t-test|||||||0.958
71118203|NCT03639623|141741315|OTHER|||||||0.011|||||||paired t-test|||||||0.011
71118204|NCT03639623|141741316|OTHER|||||||0.454|||||||paired t-test|||||||0.454
71118205|NCT03639623|141741317|OTHER|||||||0.154|||||||paired t-test|||||||0.154
71118206|NCT03639623|141741318|OTHER|||||||0.125|||||||paired t-test|||Outcome Variable: ALT||||0.125
71118207|NCT03639623|141741318|OTHER|||||||0.375|||||||paired t-test|||Outcome Variable: AST||||0.375
71118208|NCT03639623|141741318|OTHER||||||<|0.001|||||||paired t-test|||Outcome Variable: ALP||||<0.001
71118209|NCT03639623|141741319|OTHER|||||||0.054|||||||paired t-test|||||||0.054
71118210|NCT03639623|141741320|OTHER|||||||0.378|||||||paired t-test|||Outcome variable: Total Cholesterol||||0.378
71118211|NCT03639623|141741320|OTHER|||||||0.01|||||||paired t-test|||Outcome Variable: Triglyceride||||0.010
71118212|NCT03639623|141741320|OTHER|||||||0.264|||||||paired t-test|||Outcome Variable: Non-HDL-C||||0.264
71118213|NCT03639623|141741320|OTHER|||||||0.954|||||||paired t-test|||Outcome Variable: HDL-C||||0.954
71118214|NCT03639623|141741320|OTHER|||||||0.127|||||||paired t-test|||Outcome Variable: HDL-C Subclass 2||||0.127
71118215|NCT03639623|141741320|OTHER|||||||0.029|||||||paired t-test|||Outcome Variable: HDL-C Subclass 3||||0.029
71118216|NCT03639623|141741320|OTHER|||||||0.63|||||||paired t-test|||Outcome variable: LDL-C||||0.630
71118217|NCT03639623|141741320|OTHER|||||||0.01|||||||paired t-test|||Outcome Variable: VLDL-C||||0.010
71118218|NCT03639623|141741320|OTHER|||||||0.16|||||||paired t-test|||Outcome Variable: VLDL concentration||||0.160
71118219|NCT03639623|141741320|OTHER|||||||0.02|||||||paired t-test|||Small dense LDL-C||||0.020
71118220|NCT03639623|141741321|OTHER|||||||0.529|||||||paired t-test|||||||0.529
71118221|NCT03639623|141741322|OTHER|||||||0.403|||||||paired t-test|||Outcome Variable: LDL Size||||0.403
71118222|NCT03639623|141741323|OTHER|||||||0.669|||||||paired t-test|||||||0.669
71118223|NCT03639623|141741324|OTHER|||||||0.021|||||||paired t-test|||Outcome Variable: VLDL chylomicron particles||||0.021
71118224|NCT03639623|141741324|OTHER|||||||0.011|||||||paired t-test|||Outcome Variable: Large VLDL chylomicron particles||||0.011
71118225|NCT03639623|141741324|OTHER|||||||0.06|||||||paired t-test|||Outcome Variable: Medium VLDL particles||||0.060
71118226|NCT03639623|141741324|OTHER|||||||0.324|||||||paired t-test|||Outcome Variable: Small VLDL particles||||0.324
71118227|NCT03639623|141741325|OTHER|||||||0.01|||||||paired t-test|||||||0.010
71118228|NCT03639623|141741326|OTHER|||||||0.249|||||||paired t-test|||||||0.249
71118229|NCT03639623|141741327|OTHER|||||||0.0193|||||||paired t-test|||Time to peak RQ||||0.0193
71118230|NCT03639623|141741328|OTHER|||||||0.96|||||||paired t-test|||Outcome Variable: Physical component score||||0.960
71118231|NCT03639623|141741328|OTHER|||||||0.249|||||||paired t-test|||Outcome Variable: Mental component score||||0.249
71118232|NCT00889603|141741341|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.92|||||TWO_SIDED|95.0|1.65|2.2|||||Change from baseline in MMSE at LOCF analyzed using single-sample t-test; a 95% confidence interval (CI) was calculated for mean change at LOCF.|||2.20|1.65|
71118233|NCT00889603|141741342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92|||||TWO_SIDED|95.0|0.75|1.08|||||LS Mean and 95% CI for change from baseline in MMSE Total to Week 8 from repeated-measures mixed model including terms for baseline MMSE and Week.|||1.08|0.75|
71118234|NCT00889603|141741342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.56|||||TWO_SIDED|95.0|1.32|1.8|||||LS Mean and 95% CI for change from baseline in MMSE Total to Week 16 from a repeated-measures mixed model including terms for baseline MMSE and Week.|||1.80|1.32|
71118235|NCT00889603|141741342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.97|||||TWO_SIDED|95.0|1.69|2.25|||||LS Mean and 95% CI for change from baseline in MMSE Total to Week 24 from a repeated-measures mixed model including terms for baseline MMSE and Week.|||2.25|1.69|
70854399|NCT03222492|141197257|SUPERIORITY|||||||0.429||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||0.429
70942954|NCT04783519|141386208|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-4.52||||0.007|TWO_SIDED|95.0|-7.8|-1.25|||Regression, Linear|Models control for age, sex, race, and ethnicity.||"Changes from Baseline to 3 Month for BASICS+SLEEP vs. AOC reported in this section.~Score on measure (T-score method https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3261577/)"||-1.25|-7.8|.007
71118236|NCT01229254|141741351|EQUIVALENCE|If the 90% confidence interval was within the pre-specified bounds of \[0.66, 1.50\], the hypothesis of similarity between lower weight and higher weight groups was supported.|Ratio of geometric least-squares means|0.748|||||TWO_SIDED|90.0|0.591|0.948||||||Compared to Betrixaban 90 mg (≥80 kg)||0.948|0.591|
70854400|NCT03222492|141197258|SUPERIORITY|||||||0.286||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||0.286
70854401|NCT03222492|141197258|SUPERIORITY|||||||0.067||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||0.067
70854402|NCT03222492|141197259|SUPERIORITY|||||||0.1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 36||||0.100
70854403|NCT03222492|141197260|SUPERIORITY|||||||0.1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||0.100
70854404|NCT03222492|141197271|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||1.000
70854405|NCT03222492|141197271|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||1.000
70854406|NCT03222492|141197272|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||||||1.000
70854407|NCT03222492|141197272|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||1.000
70854408|NCT02189954|141197283|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
70854409|NCT02189954|141197283|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mann Whitney U|||||||<0.05
70854410|NCT00223236|141197308|SUPERIORITY_OR_OTHER|||||||0.4637|||||||Chi-squared|df=1 n=34||Null hypothsis is no group association in cocaine use.||||.4637
70854411|NCT01181986|141197312|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Adjusted for treatment sequence, group (diabetes duration) and time.||||||<0.0001
70854412|NCT01181986|141197312|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANCOVA|Adjusted for treatment sequence.||||||0.006
70854413|NCT01181986|141197312|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANCOVA|Adjusted for treatment sequence.||||||0.003
70854414|NCT01181986|141197313|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Adjusted for treatment sequence and diabetes duration group.||||||<0.0001
70854415|NCT01181986|141197314|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70854416|NCT03720652|141197315|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.18|||||||McNemar|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.18
70854417|NCT03720652|141197315|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.34|||||||McNemar|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.34
70854418|NCT03720652|141197315|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.13|||||||McNemar|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.13
70854419|NCT03720652|141197316|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.7|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.70
70854420|NCT03720652|141197316|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.66|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.66
70854421|NCT03720652|141197316|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.84|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.84
70854422|NCT03720652|141197317|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.015|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.015
70854423|NCT03720652|141197317|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.34|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.34
70854424|NCT03720652|141197317|OTHER|The statistical test is a paired test assessing change at the End-of-Program Interview relative to baseline.||||||0.002|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.002
70854425|NCT03720652|141197318|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.022|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.022
70854426|NCT03720652|141197318|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.02|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.020
71118237|NCT00521599|141741371|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|assume n=240 per group and standard deviation (STD) = 45 L/min for AM Peak Flow Rate at Week 8. If the two actives are the same, 95% CI of their mean difference has 90% probability to be completely within +/- 15 L/min.|Mean Difference (Net)|-1.62|STANDARD_DEVIATION|37.0||0.654|TWO_SIDED|95.0|-8.74|5.49|||ANOVA|||Week 8 End scores||5.49|-8.74|0.654
71118238|NCT00521599|141741371|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0|||||ANOVA|||Week 8 End scores||||0.003
71118239|NCT00521599|141741371|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||ANOVA|||Week 8 End scores||||0.001
71118240|NCT00744978|141741382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.3873|TWO_SIDED|95.0|-1.37|0.53||ANCOVA model using unstructured covariance structure; Type I error rate for primary hypothesis was 5%; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo. Analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.53|-1.37|0.3873
71118241|NCT00744978|141741383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55||||0.2465|TWO_SIDED|95.0|-0.39|1.49||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo. Analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||1.49|-0.39|0.2465
71118242|NCT00744978|141741384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.2092|TWO_SIDED|95.0|-0.33|1.5||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||1.50|-0.33|0.2092
71118243|NCT00744978|141741385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.4339|TWO_SIDED|95.0|-1.3|0.56||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.56|-1.30|0.4339
71118244|NCT00744978|141741386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9745|TWO_SIDED|95.0|-0.26|0.27|||ANCOVA|||Difference from placebo analyzed using a mixed effects linear model with subject (nested within sequence) as a random effect, and stratum, site, period, sequence, and treatment as fixed effects.||0.27|-0.26|0.9745
71118245|NCT00744978|141741387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68||||0.2852|TWO_SIDED|95.0|-0.57|1.92||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||1.92|-0.57|0.2852
71118246|NCT00744978|141741388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.28||||0.0468|TWO_SIDED|95.0|0.02|2.53||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||2.53|0.02|0.0468
71118247|NCT00744978|141741389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.8811|TWO_SIDED|95.0|-0.02|0.03||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.03|-0.02|0.8811
71118248|NCT00744978|141741390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.083|TWO_SIDED|95.0|0.0|0.05||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.05|-0.00|0.0830
71118249|NCT00744978|141741391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.7226|TWO_SIDED|95.0|-0.03|0.02||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.02|-0.03|0.7226
71118250|NCT00744978|141741392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.53||||0.5588|TWO_SIDED|95.0|-6.68|3.62||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Week 1: difference from placebo. Analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||3.62|-6.68|0.5588
71118251|NCT00744978|141741393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.15||||0.1173|TWO_SIDED|95.0|-9.34|1.05||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||1.05|-9.34|0.1173
70854427|NCT03720652|141197318|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.09|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.090
71079929|NCT04227405|141667030|SUPERIORITY||Slope|0.91|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Relationship Quality subscale for the intervention group||||<.001
71079930|NCT04227405|141667030|SUPERIORITY||Slope|0.5|STANDARD_ERROR_OF_MEAN|0.26|<|0.1|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables. Pvalue set at \<.05|Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is not significantly (p \> .05) different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up n the Relationship Quality subscale||||<.10
71079931|NCT04227405|141667030|SUPERIORITY||Slope|-0.31|STANDARD_ERROR_OF_MEAN|0.13|<|0.1|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Emotional Abuse subscale for the control group||||<.10
71079932|NCT04227405|141667030|SUPERIORITY||Slope|-0.71|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Emotional Abuse subscale for the intervention group||||<.001
71079933|NCT04227405|141667030|SUPERIORITY||Slope|-0.41|STANDARD_ERROR_OF_MEAN|0.2|<|0.1|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected decrease from pre-test to follow-up in the intervention group is not significantly (p \> .05) different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Emotional Abuse subscale||||<.10
71079934|NCT04227405|141667030|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Relationship subscale for the control group||||>.05
71079935|NCT04227405|141667030|SUPERIORITY||Slope|0.29|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Relationship Satisfaction subscale for the intervention group||||<.001
71079936|NCT04227405|141667030|SUPERIORITY||Slope|0.26|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Relationship Satisfaction subscale||||<.001
71079937|NCT04227405|141667030|SUPERIORITY||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Relationship Commitment subscale for the control group||||>.05
71079938|NCT04227405|141667030|SUPERIORITY||Slope|0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Relationship Commitment subscale for the intervention group||||<.001
71079939|NCT04227405|141667030|SUPERIORITY||Slope|0.32|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Relationship Commitment subscale||||<.001
70854428|NCT03720652|141197319|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.051|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.051
70942955|NCT04783519|141386208|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-0.83||||0.621|TWO_SIDED|95.0|-4.12|2.46|||Regression, Linear|Models control for age, sex, race, and ethnicity.||Changes from Baseline to 3 Month for BASICS vs. AOC reported in this section. Score on measure (T-score method https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3261577/ )||2.46|-4.12|.621
70942956|NCT04783519|141386209|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.802||||0.054|TWO_SIDED|95.0|0.641|1.003|||Mixed Models Analysis|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||1.003|0.641|.054
70942957|NCT04783519|141386209|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.75||||0.015|TWO_SIDED|95.0|0.6|0.946|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||0.946|0.600|.015
70942958|NCT04783519|141386209|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.736||||0.013|TWO_SIDED|95.0|0.578|0.937|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||0.937|0.578|.013
70942959|NCT04783519|141386209|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.658||||0.001|TWO_SIDED|95.0|0.513|0.844|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||0.844|0.513|.001
70942960|NCT04783519|141386210|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.992||||0.96|TWO_SIDED|95.0|0.716|1.374|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||1.374|0.716|.960
70942961|NCT04783519|141386210|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.782||||0.152|TWO_SIDED|95.0|0.506|1.094|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||1.094|0.506|.152
70942962|NCT04783519|141386210|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.887||||0.482|TWO_SIDED|95.0|0.634|1.24|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||1.240|0.634|.482
71118252|NCT00744978|141741394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31||||0.6251|TWO_SIDED|95.0|-6.58|3.96||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||3.96|-6.58|0.6251
71118253|NCT00744978|141741395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9109|TWO_SIDED|95.0|-0.05|0.05||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.05|-0.05|0.9109
70942963|NCT04783519|141386210|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.67||||0.02|TWO_SIDED|95.0|0.634|1.24|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||1.240|0.634|.020
70942964|NCT04783519|141386211|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.724||||0.032|TWO_SIDED|95.0|0.54|0.973|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||0.973|0.540|.032
70942965|NCT04783519|141386211|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.588|||<|0.001|TWO_SIDED|95.0|0.432|0.8|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||0.800|0.432|<.001
71118254|NCT00744978|141741396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.6632|TWO_SIDED|95.0|-0.06|0.04||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.04|-0.06|0.6632
70854429|NCT03720652|141197319|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.044|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.044
70854430|NCT03720652|141197319|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||1|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||1.00
70854431|NCT03720652|141197320|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.023|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.023
70854432|NCT03720652|141197320|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.56|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.56
70854433|NCT03720652|141197320|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.16|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.16
70854434|NCT03720652|141197321|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.15|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.15
70854435|NCT03720652|141197321|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.12|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.12
70854436|NCT03720652|141197321|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.018|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.018
70954220|NCT00688870|141411075|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.62|||||TWO_SIDED|95.0|0.5|0.78|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 4||0.78|0.50|
70854437|NCT03720652|141197322|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.33|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.33
70854438|NCT03720652|141197322|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.88|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.88
70854439|NCT03720652|141197322|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.67|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.67
70854440|NCT03720652|141197323|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
70854441|NCT03720652|141197323|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
70854442|NCT03720652|141197323|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
70854443|NCT03720652|141197324|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.17|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.17
70854444|NCT03720652|141197324|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.02|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.020
70854445|NCT03720652|141197324|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.062|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.062
70854446|NCT03720652|141197325|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.013|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.013
71079940|NCT04227405|141667030|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Positive Conflict Management subscale for the control group||||>.05
71079941|NCT04227405|141667030|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Positive Conflict Management subscale for th eintervention group||||>.05
70854447|NCT03720652|141197325|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.001
70854448|NCT03720652|141197325|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.003|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.003
71079942|NCT04227405|141667030|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.14|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Positive Conflict Management subscale||||>.05
71079943|NCT04227405|141667030|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Negative Conflict Management subscale for the control group||||>.05
71079944|NCT04227405|141667030|SUPERIORITY||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Negative Conflict Management subscale for the intervention group||||>.05
71079945|NCT04227405|141667030|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.14|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Negative Conflict Management subscale||||>.05
71079946|NCT04227405|141667030|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Relationship Quality subscale for the control group||||>.05
71079947|NCT04227405|141667030|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Relationship Quality subscale for the intervention group||||>.05
71079948|NCT04227405|141667030|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Relationship Quality subscale||||>.05
71118255|NCT00744978|141741397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.545|TWO_SIDED|95.0|-0.07|0.04||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.04|-0.07|0.5450
71118256|NCT00744978|141741398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.2799|TWO_SIDED|95.0|-0.02|0.05||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.05|-0.02|0.2799
71118257|NCT00744978|141741399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9675|TWO_SIDED|95.0|-0.03|0.04||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo aAnalyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.04|-0.03|0.9675
71079949|NCT04227405|141667030|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Emotional Abuse subscale for the control group||||>.05
71079950|NCT04227405|141667030|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||Changes from post-test to Follow-up in the Emotional Abuse subscale for the control group|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Emotional Abuse subscale for the intervention group||||>.05
71079951|NCT04227405|141667030|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Emotional Abuse subscale||||>.05
70942966|NCT04783519|141386212|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.699||||0.009|TWO_SIDED|95.0|0.535|0.914|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||0.914|0.535|.009
70942967|NCT04783519|141386212|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.675||||0.005|TWO_SIDED|95.0|0.512|0.888|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||0.888|0.512|.005
70942968|NCT04783519|141386212|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.698||||0.013|TWO_SIDED|95.0|0.526|0.928|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||0.928|0.526|.013
70942969|NCT04783519|141386212|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.525|||<|0.001|TWO_SIDED|95.0|0.385|0.715|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||0.715|0.385|<.001
70942970|NCT04783519|141386213|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.598||||0.01|TWO_SIDED|95.0|0.404|0.885|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||0.885|0.404|.010
70942971|NCT04783519|141386213|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.502||||0.001|TWO_SIDED|95.0|0.331|0.76|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||0.760|0.331|.001
70942972|NCT04783519|141386213|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.516||||0.002|TWO_SIDED|95.0|0.337|0.79|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||0.790|0.337|.002
71079952|NCT04227405|141667030|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.01|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Relationship Satisfaction subscale for the control group||||>.05
70854449|NCT03720652|141197326|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.001
71079953|NCT04227405|141667030|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Relationship Satisfaction subscale for the interventionn group||||>.05
70942973|NCT04783519|141386213|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.506||||0.002|TWO_SIDED|95.0|0.33|0.774|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||0.774|0.330|.002
70942974|NCT04783519|141386214|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category.|count/rate ratio|0.628||||0.003|TWO_SIDED|95.0|0.462|0.853|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||0.853|0.462|.003
70854450|NCT03720652|141197326|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.01|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.010
70854451|NCT03720652|141197326|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.085|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.085
70854452|NCT03720652|141197327|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
71118258|NCT00744978|141741400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.5008|TWO_SIDED|95.0|-0.05|0.02||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.02|-0.05|0.5008
71118259|NCT00744978|141741401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.2245|TWO_SIDED|95.0|-0.03|0.01||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.01|-0.03|0.2245
71118260|NCT00744978|141741402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.4974|TWO_SIDED|95.0|-0.03|0.01||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.01|-0.03|0.4974
71118261|NCT00744978|141741403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.8525|TWO_SIDED|95.0|-0.02|0.02||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.02|-0.02|0.8525
71118262|NCT01218958|141741404|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.751||||0.0245|TWO_SIDED|95.0|0.6|0.94||The Hochberg method was used to adjust P-value for multiple comparisons (ie, 380 mg dose vs. placebo and 190 mg dose vs. placebo).|Andersen-Gill recurrent-event Cox|||"The event rate (percentage) is represented by the number of heavy drinking days divided by number of days at risk. For each day, the active groups' results were contrasted with placebo to form the event rate ratio. Thus, a hazard ratio of 0.75 for the 380 mg group indicates a 25% reduction in heavy drinking compared with that of placebo.~The method of analysis estimates the average ratio over time and accounts for discontinuation. Point/interval estimates for pairwise ratios were derived."||0.940|0.600|0.0245
71118263|NCT01218958|141741404|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0744|TWO_SIDED|95.0|0.677|1.018|||Andersen-Gill recurrent-event Cox model|||||1.018|0.677|0.0744
71118264|NCT01179217|141741425|SUPERIORITY_OR_OTHER_LEGACY||Wilcoxon rank-sum test|0.5||||0.0052|TWO_SIDED|||||"1. The primary analysis was analyzed using a CMH analysis of the number of SCCs using modified ridit scores.~2. P-value (controlling for region and HU use)~3. The null hypothesis of the final analysis was performed at the 0.045 significance level."|Cochran-Mantel-Haenszel|||||||0.0052
71118265|NCT01179217|141741426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0045|||||||Cochran-Mantel-Haenszel|||||||0.0045
70854453|NCT03720652|141197327|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
70854454|NCT03720652|141197327|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
71118266|NCT01179217|141741427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0888|||||||Cochran-Mantel-Haenszel|||||||0.0888
71118267|NCT01849575|141741440|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.001
71118268|NCT04077996|141741452|NON_INFERIORITY|The margin of non inferiority analysis was established at 30%.|Risk Ratio (RR)|1.11|STANDARD_DEVIATION|95.0|<|0.05|TWO_SIDED|95.0|0.91|1.3|||Chi-squared, Corrected|||Summary statistics were computed, and a significance level (α) of 5% has been established.||1.3|0.91|<0.05
71118269|NCT04077996|141741452|NON_INFERIORITY|margin 30%|Risk Ratio (RR)|1.0|STANDARD_DEVIATION|95.0|<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||||||<0.05
71118270|NCT04077996|141741453|NON_INFERIORITY|The margin was established at 30%.|Risk Ratio (RR)|1.0|STANDARD_DEVIATION|95.0|<|0.05|TWO_SIDED|1.0|0.14|6.6|||Fisher Exact|||||6.6|0.14|<0.05
71118271|NCT01639339|141741460|OTHER||Odds Ratio (OR)|1.55||||0.0311|TWO_SIDED|95.0|1.04|2.32||P-value was calculated using logistic regression model. Test 1 of 5 in a step-down sequential testing procedure.|Regression, Logistic||Treatment comparison between Belimumab 10 mg/kg and placebo using odds ratio and its corresponding 95% confidence interval has been presented.|||2.32|1.04|0.0311
71118272|NCT01639339|141741461|OTHER||Odds Ratio (OR)|1.74||||0.0167|TWO_SIDED|95.0|1.11|2.74||P-value was calculated using logistic regression model. Test 2 of 5 in a step-down sequential testing procedure.|Regression, Logistic||Treatment comparison between Belimumab 10 mg/kg and placebo using odds ratio and its corresponding 95% confidence interval has been presented.|||2.74|1.11|0.0167
71118273|NCT01639339|141741462|OTHER||Odds Ratio (OR)|1.59||||0.0245|TWO_SIDED|95.0|1.06|2.38||P-value was calculated using logistic regression model. Test 3 of 5 in a step-down sequential testing procedure.|Regression, Logistic||Treatment comparison between Belimumab 10 mg/kg and placebo using odds ratio and its corresponding 95% confidence interval has been presented.|||2.38|1.06|0.0245
70942975|NCT04783519|141386214|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category.|count/rate ratio|0.744||||0.073|TWO_SIDED|95.0|0.538|1.028|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||1.028|0.538|.073
70942976|NCT04783519|141386214|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category.|count/rate ratio|0.764||||0.09|TWO_SIDED|95.0|0.559|1.043|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||1.043|0.559|.090
70942977|NCT04783519|141386214|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category.|count/rate ratio|0.656||||0.013|TWO_SIDED|95.0|0.469|0.916|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||0.916|0.469|.013
70942978|NCT04783519|141386215|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.753||||0.087|TWO_SIDED|95.0|0.546|1.041|||Generalized linear mixed model|Model controls for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||1.041|0.546|.087
70942979|NCT04783519|141386215|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.739||||0.078|TWO_SIDED|95.0|0.528|1.034|||Generalized linear mixed model|Model controls for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||1.034|0.528|.078
70942980|NCT04783519|141386215|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.773||||0.099|TWO_SIDED|95.0|0.569|1.05|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||1.050|0.569|.099
70942981|NCT04783519|141386215|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.704||||0.031|TWO_SIDED|95.0|0.512|0.969|||Generalized linear mixed model|Model controls for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||0.969|0.512|.031
70942982|NCT00645099|141386226|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||Based on available data it was estimated that in the paliperidone ER group the TG:HDL ratio would decrease with 0.15 and that the TG:HDL ratio would increase with 0.25 in the olanzapine group. The common SD of the change was estimated to be 1.4. A sample size of 205 patients in each treatment arm had 80% power to detect a difference of 0.4 in change of TG:HDL ratio after 6 months of treatment in favor of paliperidone ER treatment (Wilcoxon two-sample test with 0.05 two-sided significance level).||||< 0.0001
70942983|NCT00645099|141386226|SUPERIORITY_OR_OTHER|||||||0.4718||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group comparison of the change from baseline at end point.||||0.4718
70942984|NCT00645099|141386226|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline at end point.||||< 0.0001
71118274|NCT01639339|141741463|OTHER||Cox Proportional Hazard|0.51||||0.0014|TWO_SIDED|95.0|0.34|0.77||P-value was calculated using Cox proportional hazards model. Test 4 of 5 in a step-down sequential testing procedure.|Cox proportional hazards model||Treatment comparison between Belimumab 10 mg/kg and placebo using Cox proportional hazards ratio and its corresponding 95% confidence interval has been presented.|||0.77|0.34|0.0014
70942985|NCT00645099|141386227|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||<0.0001
70942986|NCT00645099|141386227|SUPERIORITY_OR_OTHER|||||||0.9143||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||0.9143
70942987|NCT00645099|141386227|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||<0.0001
70942988|NCT00645099|141386228|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.0050
70942989|NCT00645099|141386228|SUPERIORITY_OR_OTHER|||||||0.4454||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||0.4454
70942990|NCT00645099|141386228|SUPERIORITY_OR_OTHER|||||||0.0018||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||0.0018
70942991|NCT00645099|141386229|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||<0.0001
70942992|NCT00645099|141386230|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.0004
70942993|NCT00645099|141386231|SUPERIORITY_OR_OTHER|||||||0.0272||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.0272
70942994|NCT00645099|141386232|SUPERIORITY_OR_OTHER|||||||0.1892||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.1892
70942995|NCT00645099|141386233|SUPERIORITY_OR_OTHER|||||||0.0325||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.0325
70942996|NCT00645099|141386234|SUPERIORITY_OR_OTHER|||||||0.1117||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.1117
70942997|NCT00645099|141386235|SUPERIORITY_OR_OTHER|||||||0.6346||95.0|||||Fisher Exact|This test was interpreted at the 5% significance level (2-tailed).||||||0.6346
70942998|NCT00645099|141386236|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|This test was interpreted at the 5% significance level (2-tailed).||||||1.0000
70854455|NCT03720652|141197328|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.046|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.046
70854456|NCT03720652|141197328|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.14|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.14
70854457|NCT03720652|141197328|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.058|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.058
70854458|NCT03720652|141197329|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
71118275|NCT01639339|141741464|OTHER|||||||0.0096||||||P-value is rank analysis of covariance model comparing Belimumab and Placebo with covariates for treatment group, induction regimen(CYC vs MMF),race(Black vs Non-black), Baseline uPCR, and eGFR. Test 5 of 5 in step-down sequential testing procedure.|Rank ANCOVA|||||||0.0096
70854459|NCT03720652|141197329|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
70942999|NCT00645099|141386237|SUPERIORITY_OR_OTHER|||||||0.677||95.0|||||Fisher Exact|This test was interpreted at the 5% significance level (2-tailed).||||||0.6770
71118276|NCT03022097|141741469|SUPERIORITY||Least squares mean difference|0.092|STANDARD_ERROR_OF_MEAN|0.016|<|0.001|TWO_SIDED|95.0|0.06|0.124||Pre-specified hierarchical sequence of testing used to adjust for multiplicity.|Mixed Models Analysis|Screening pre- and post-bronchodilator FEV1, age, baseline FEV1 as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||0.124|0.060|<0.001
71118277|NCT03022097|141741470|SUPERIORITY||Least squares mean difference|0.085|STANDARD_ERROR_OF_MEAN|0.016|<|0.001|TWO_SIDED|95.0|0.053|0.117||Pre-specified hierarchical sequence of testing used to adjust for multiplicity.|Mixed Models Analysis|Screening pre- and post-bronchodilator FEV1, age, baseline FEV1 as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||0.117|0.053|<0.001
71118278|NCT03022097|141741471|SUPERIORITY||Least squares mean difference|0.134|STANDARD_ERROR_OF_MEAN|0.016|<|0.001|TWO_SIDED|95.0|0.103|0.166||Pre-specified hierarchical sequence of testing used to adjust for multiplicity.|Mixed Models Analysis|Screening pre- and post-bronchodilator FEV1, age, baseline FEV1 as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||0.166|0.103|<0.001
71118279|NCT03022097|141741472|SUPERIORITY||Least squares mean difference|0.217|STANDARD_ERROR_OF_MEAN|0.017|<|0.001|TWO_SIDED|95.0|0.184|0.25||Pre-specified hierarchical sequence of testing used to adjust for multiplicity.|Mixed Models Analysis|Screening pre- and post-bronchodilator FEV1, age, baseline FEV1 as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||0.250|0.184|<0.001
71118280|NCT03022097|141741473|SUPERIORITY||Least squares mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.3||0.005|TWO_SIDED|95.0|0.2|1.3||Pre-specified hierarchical sequence of testing used to adjust for multiplicity.|Mixed Models Analysis|BDI, age as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||1.3|0.2|0.005
71118281|NCT03022097|141741473|SUPERIORITY||Least squares mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.3||0.132|TWO_SIDED|95.0|-0.1|1.0||Pre-specified hierarchical sequence of testing used to adjust for multiplicity.|Mixed Models Analysis|BDI, age as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||1.0|-0.1|0.132
71118282|NCT03022097|141741474|SUPERIORITY||Least squares mean difference|-4.0|STANDARD_ERROR_OF_MEAN|1.3||0.003|TWO_SIDED|95.0|-6.7|-1.4||Pre-specified hierarchical sequence of testing used to adjust for multiplicity. P-value is nominal.|Mixed Models Analysis|Baseline SGRQ, age as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||-1.4|-6.7|0.003
71118283|NCT03022097|141741474|SUPERIORITY||Least squares mean difference|-2.9|STANDARD_ERROR_OF_MEAN|1.3||0.031|TWO_SIDED|95.0|-5.5|-0.3||Pre-specified hierarchical sequence of testing used to adjust for multiplicity. P-value is nominal.|Mixed Models Analysis|Baseline SGRQ, age as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||-0.3|-5.5|0.031
71118284|NCT04470908|141741485|OTHER|Estimate the geometric least square mean ratio of Zanubrutinib vs Zanubrutinib + Rifabutin|Ratio of Geometric Least Squares Means|0.566|||||TWO_SIDED|90.0|0.525|0.61||||||||0.610|0.525|
71118285|NCT04470908|141741486|OTHER|Estimate the geometric least square mean ratio of Zanubrutinib vs Zanubrutinib + Rifabutin|Ratio of Geometric Least Squares Means|0.56|||||TWO_SIDED|90.0|0.532|0.589||||||||0.589|0.532|
71118286|NCT04470908|141741487|OTHER|Estimate the geometric least square mean ratio of Zanubrutinib vs Zanubrutinib + Rifabutin|Ratio of Geometric Least Squares Means|0.518|||||TWO_SIDED|90.0|0.441|0.608||||||||0.608|0.441|
71118287|NCT04730635|141741539|OTHER||Posterior Probability|46.3||||||||||||||There was a threshold of ≥2 percentage points. A posterior probability value \>55% was required to satisfy the primary hypothesis.||||
71118288|NCT04730635|141741540|OTHER||Posterior Probability|80.67||||||||||||||There was a threshold of ≤ 0.1 for this standard deviation change. A posterior probability value \>70% was required to satisfy this secondary hypothesis.||||
71118289|NCT04730635|141741541|OTHER||Posterior Probability|98.8||||||||||||||||||
71118290|NCT02118766|141741556|SUPERIORITY_OR_OTHER|||||||0.038|||||||Regression, Logistic|||||||0.038
71118291|NCT03219034|141741568|SUPERIORITY||Median Difference (Final Values)|3.8||||0.152|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Cross-over design: Median differences between oral appliances at the end of the first 4-week leg of the study (T2). The hypothesis tested was that REI would be lowered more with Appliance A than B.||||0.152
71118292|NCT02438683|141741570|OTHER||Slope|0.0029|||||TWO_SIDED|95.0|0.0012|0.0046||||The covariance structure is No diagonal Factor Analytic FA0(2).||The regression model with response variable placebo-corrected HR change from baseline (ddHR) and independent variable Plasma concentration includes a fixed slope effect as well as random intercept and slope estimates for each subject. (Primary analysis).||0.0046|0.0012|
70854460|NCT03720652|141197329|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
70854461|NCT03073733|141197336|SUPERIORITY||least squares mean difference|-2.2|STANDARD_ERROR_OF_MEAN|2.9||0.582|TWO_SIDED|95.0|-10.3|5.8|||linear model for repeated measures|||||5.8|-10.3|0.582
70943000|NCT00645099|141386238|SUPERIORITY_OR_OTHER|||||||0.1308||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.1308
70854462|NCT03073733|141197336|SUPERIORITY||least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|2.91||0.984|TWO_SIDED|95.0|-8.2|8.0|||linear model for repeated measures|||||8.0|-8.2|0.984
70854463|NCT03073733|141197337|SUPERIORITY||least squares mean difference|1.2986|STANDARD_ERROR_OF_MEAN|0.8744||0.29|TWO_SIDED|95.0|-1.1341|3.7313|||linear model for repeated measures|||||3.7313|-1.1341|0.290
70854464|NCT03073733|141197337|SUPERIORITY||least squares mean difference|-0.3542|STANDARD_ERROR_OF_MEAN|0.7793||0.759|TWO_SIDED|95.0|-2.6516|1.9433|||linear model for repeated measures|||||1.9433|-2.6516|0.759
70854465|NCT03073733|141197338|SUPERIORITY||least squares mean difference|-278.73|STANDARD_ERROR_OF_MEAN|305.192||0.515|TWO_SIDED|95.0|-1126.21|568.75|||linear model for repeated measures|||||568.75|-1126.21|0.515
70854466|NCT03073733|141197338|SUPERIORITY||least squares mean difference|292.18|STANDARD_ERROR_OF_MEAN|308.659||0.499|TWO_SIDED|95.0|-562.87|1147.23|||linear model for repeated measures|||||1147.23|-562.87|0.499
70943001|NCT00645099|141386239|SUPERIORITY_OR_OTHER|||||||0.3358||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.3358
70943002|NCT00645099|141386240|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||<0.0001
71079954|NCT04227405|141667030|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Relationship satisfaction subscale||||>.05
71079955|NCT04227405|141667030|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to Follow-up in the Emotional Abuse subscale for the control group|Changes from post-test to Follow-up in the Relationship Commitment subscale for the control group||||>.05
70943003|NCT00645099|141386240|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||0.0001
71079956|NCT04227405|141667030|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Relationship Commitment subscale for the intervention group||||>.05
71118293|NCT02438683|141741571|OTHER||Mean Difference (Net)|3.85|STANDARD_ERROR_OF_MEAN|1.75|||TWO_SIDED|90.0|0.73|6.97||||For the repeated effect 'time', the covariance structure was chosen to be unstructured.|Mean Difference (Net) is actually the adjusted mean difference calculated as BI 409306 50 mg minus Placebo.|The a repeated measures model included 'period baseline', 'subject baseline' (defined as the arithmetic mean of the 2 period baselines), 'treatment', 'baseline\*time' interaction, 'treatment\*time' interaction and 'time' as fixed effects and subject as random effect (Primary analysis).||6.97|0.73|
71118294|NCT02438683|141741572|OTHER||Mean Difference (Net)|4.93|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|90.0|1.69|8.16||||For the repeated effect 'time', the covariance structure was chosen to be unstructured.|Mean Difference (Net) is actually the adjusted mean difference calculated as BI 409306 200 mg minus Placebo.|The a repeated measures model included 'period baseline', 'subject baseline' (defined as the arithmetic mean of the 2 period baselines), 'treatment', 'baseline\*time' interaction, 'treatment\*time' interaction and 'time' as fixed effects and subject as random effect (Primary analysis).||8.16|1.69|
71118295|NCT02438683|141741573|OTHER||Slope|0.0011|||||TWO_SIDED|95.0|-0.0009|0.003||||The covariance structure is No diagonal Factor Analytic FA0(2).||The regression model with response variable placebo-corrected QTcF change from baseline (ddQTcF) and independent variable. Plasma concentration includes a fixed slope effect as well as random intercept and slope estimates for each subject (Primary analysis). The covariance structure is No diagonal Factor Analytic FA0(2).||0.0030|-0.0009|
71118296|NCT02438683|141741574|OTHER||Mean Difference (Net)|4.54|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|90.0|3.39|5.7||||For the repeated effect 'time', the covariance structure was chosen to be unstructured.|Mean Difference (Net) is actually the adjusted mean difference calculated as BI 409306 50 mg minus Placebo.|The a repeated measures model included 'period baseline', 'subject baseline' (defined as the arithmetic mean of the 2 period baselines), 'treatment', 'baseline\*time' interaction, 'treatment\*time' interaction and 'time' as fixed effects and subject as random effect (Primary analysis).||5.70|3.39|
71118297|NCT02438683|141741575|OTHER||Mean Difference (Net)|4.73|STANDARD_ERROR_OF_MEAN|1.99|||TWO_SIDED|90.0|1.34|8.13||||For the repeated effect 'time', the covariance structure was chosen to be unstructured.|Mean Difference (Net) is actually the adjusted mean difference calculated as BI 409306 200 mg minus Placebo.|The a repeated measures model included 'period baseline', 'subject baseline' (defined as the arithmetic mean of the 2 period baselines), 'treatment', 'baseline\*time' interaction, 'treatment\*time' interaction and 'time' as fixed effects and subject as random effect (Primary analysis).||8.13|1.34|
71118298|NCT02438683|141741576|OTHER||Slope|0.0054|||||TWO_SIDED|95.0|0.0032|0.0076||||The covariance structure is Unstructured.||The regression model with response variable placebo-corrected max HR (dHR) and independent variable Plasma concentration includes a fixed slope effect as well as random intercept and slope estimates for each subject. (Primary analysis)||0.0076|0.0032|
71118299|NCT02438683|141741577|OTHER||Slope|-0.0014|||||TWO_SIDED|95.0|-0.0036|0.0008||||The covariance structure is Unstructured.||The regression model with response variable placebo-corrected change from max HR to recovery HR (ddHR) and independent variable Plasma concentration includes a fixed slope effect as well as random intercept estimates for each subject (Primary analysis).||0.0008|-0.0036|
70854467|NCT03073733|141197339|SUPERIORITY||least squares mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.42||0.16|TWO_SIDED|95.0|-2.1|0.3|||linear model for repeated measures|||||0.3|-2.1|0.160
71079957|NCT04227405|141667030|SUPERIORITY||Slope|0.05|STANDARD_ERROR_OF_MEAN|0.18|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Relationship Commitment subscale||||>.05
71079958|NCT04227405|141667030|SUPERIORITY||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in banking subscale for the control group||||>.05
71079959|NCT04227405|141667030|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in banking subscale for the intervention group||||>.05
71079960|NCT04227405|141667030|SUPERIORITY||Slope|0.07|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up in Banking subscale||||>.05
71079961|NCT04227405|141667030|SUPERIORITY||Slope|0.11|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in banking subscale for the control group||||<.001
71079962|NCT04227405|141667030|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in banking subscale for the intervention group||||<.001
71079963|NCT04227405|141667030|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.03|<|0.1|TWO_SIDED|||||No adjustment to p value|Multilevel modeling|||Difference between the control and the intervention group in the change from post-test to follow-up in Banking subscale|Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|||<.10
71079964|NCT04227405|141667030|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Difficulty to Pay Bills for the control group||||>.05
71079965|NCT04227405|141667030|SUPERIORITY||Slope|-0.19|STANDARD_ERROR_OF_MEAN|0.07|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Difficulties to Pay Bills subscale for the intervention group||||<.05
71079966|NCT04227405|141667030|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.09|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up in Difficulties to pay bills subscale||||>.05
71079967|NCT04227405|141667030|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in Difficulty to Pay Bills subscale for the control group||||>.05
71079968|NCT04227405|141667030|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.03|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in Difficulties to Pay Bills subscale for the intervention group||||>.05
71079969|NCT04227405|141667030|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.03|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up in Difficulty to Pay Bills subscale||||>.05
71079970|NCT04227405|141667030|SUPERIORITY||Slope|-0.69|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|||||No adjustment to p vallue|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in depression subscale for the control group||||<.001
71079971|NCT04227405|141667030|SUPERIORITY||Slope|-0.72|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in depression subscale for the intervention group||||<.001
71079972|NCT04227405|141667030|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.32|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up in Depression subscale||||>.05
71079973|NCT04227405|141667030|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in depression subscale for the control group||||>.05
71079974|NCT04227405|141667030|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in depression subscale for the intervention group||||>.05
70854468|NCT03073733|141197339|SUPERIORITY||least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.43||0.622|TWO_SIDED|95.0|-1.5|0.9|||linear model for repeated measures|||||0.9|-1.5|0.622
70854469|NCT03073733|141197340|SUPERIORITY||least squares mean difference|-0.111|STANDARD_ERROR_OF_MEAN|0.1038||0.442|TWO_SIDED|95.0|-0.399|0.176|||linear model for repeated measures|||||0.176|-0.399|0.442
70854470|NCT03073733|141197340|SUPERIORITY||least squares mean difference|0.122|STANDARD_ERROR_OF_MEAN|0.1037||0.401|TWO_SIDED|95.0|-0.165|0.409|||linear model for repeated measures|||||0.409|-0.165|0.401
70854471|NCT03073733|141197342|SUPERIORITY|||||||0.205|||||||Fisher Exact|||||||0.205
70854472|NCT03073733|141197343|SUPERIORITY|||||||0.157|||||||Fisher Exact|||||||0.157
70854473|NCT03073733|141197344|SUPERIORITY|||||||0.125|||||||Fisher Exact|||||||0.125
70854474|NCT03073733|141197345|SUPERIORITY|||||||0.173|||||||Fisher Exact|||||||0.173
70854475|NCT03073733|141197346|SUPERIORITY|||||||0.099|||||||t-test, 1 sided|Pooled t-test (variance ratio of 3.2)||||||0.099
70854476|NCT03073733|141197346|SUPERIORITY|||||||0.13|||||||t-test, 1 sided|Pooled t-test (variance ratio of 1.9)||||||0.130
70854477|NCT03073733|141197347|SUPERIORITY|||||||0.0959|||||||Fisher Exact|||||||0.0959
70854478|NCT03073733|141197348|SUPERIORITY|||||||0.1868|||||||Fisher Exact|||||||0.1868
70854479|NCT03073733|141197349|SUPERIORITY|||||||0.608|||||||Fisher Exact|||||||0.608
70854480|NCT03073733|141197350|SUPERIORITY|||||||0.264|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 7.9)||||||0.264
70854481|NCT03073733|141197350|SUPERIORITY|||||||0.139|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 25.9)||||||0.139
70854482|NCT03073733|141197351|SUPERIORITY|||||||0.261|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 7.9)||||||0.261
70854483|NCT03073733|141197351|SUPERIORITY|||||||0.139|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 6.3)||||||0.139
70854484|NCT03073733|141197352|SUPERIORITY|||||||0.35|||||||t-test, 1 sided|Pooled t-test (variance ratio of 0.8).||||||0.350
70854485|NCT03073733|141197352|SUPERIORITY|||||||0.5|||||||t-test, 1 sided|Pooled t-test (variance ratio of 2.5)||||||0.500
70854486|NCT03073733|141197353|SUPERIORITY|||||||0.22|||||||t-test, 1 sided|Pooled t-test (variance ratio of 2.9).||||||0.220
70854487|NCT03073733|141197353|SUPERIORITY|||||||0.119|||||||t-test, 1 sided|Pooled t-test (variance ratio of 1.9).||||||0.119
70854488|NCT03073733|141197354|SUPERIORITY|||||||0.006|||||||t-test, 1 sided|Pooled t-test (variance ratio of 2.7)||||||0.006
70854489|NCT03073733|141197355|SUPERIORITY|||||||0.009|||||||Fisher Exact|||||||0.009
70854490|NCT03073733|141197356|SUPERIORITY|||||||0.029|||||||Fisher Exact|||||||0.029
70854491|NCT03073733|141197357|SUPERIORITY|||||||0.01|||||||Fisher Exact|||||||0.010
70854492|NCT03073733|141197358|SUPERIORITY|||||||0.072|||||||Fisher Exact|||||||0.072
70854493|NCT03073733|141197359|SUPERIORITY|||||||0.019|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 5.9)||||||0.019
70854494|NCT03073733|141197359|SUPERIORITY|||||||0.019|||||||t-test, 1 sided|Pooled t-test (variance ratio of 3.98)||||||0.019
70854495|NCT03073733|141197360|SUPERIORITY|||||||0.013|||||||Fisher Exact|||||||0.013
70854496|NCT03073733|141197361|SUPERIORITY|||||||0.033|||||||Fisher Exact|||||||0.033
70854497|NCT03073733|141197362|SUPERIORITY|||||||0.199|||||||Fisher Exact|||||||0.199
70854498|NCT03073733|141197363|SUPERIORITY|||||||0.075|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 56.3)||||||0.075
70854499|NCT03073733|141197363|SUPERIORITY|||||||0.062|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 25.2)||||||0.062
70854500|NCT03073733|141197364|SUPERIORITY|||||||0.255|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 9.9)||||||0.255
70854501|NCT03073733|141197364|SUPERIORITY|||||||0.109|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 8.7)||||||0.109
70854502|NCT03073733|141197365|SUPERIORITY|||||||0.488|||||||t-test, 1 sided|Pooled t-test (variance ratio of 0.7).||||||0.488
70854503|NCT03073733|141197365|SUPERIORITY|||||||0.273|||||||t-test, 1 sided|Pooled t-test (variance ratio of 2.5)||||||0.273
70854504|NCT03073733|141197366|SUPERIORITY|||||||0.004|||||||Fisher Exact|||||||0.004
70854505|NCT03073733|141197367|SUPERIORITY|||||||0.006|||||||Fisher Exact|||||||0.006
70854506|NCT03073733|141197368|SUPERIORITY|||||||0.016|||||||Fisher Exact|||||||0.016
70854507|NCT03073733|141197369|SUPERIORITY|||||||0.098|||||||Fisher Exact|||||||0.098
70854508|NCT03073733|141197370|SUPERIORITY|||||||0.019|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 8.2)||||||0.019
70854509|NCT03073733|141197370|SUPERIORITY|||||||0.011|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 4.7)||||||0.011
70854510|NCT03073733|141197371|SUPERIORITY|||||||0.039|||||||Fisher Exact|||||||0.039
70854511|NCT03073733|141197372|SUPERIORITY|||||||0.096|||||||Fisher Exact|||||||0.096
70854512|NCT03073733|141197373|SUPERIORITY|||||||0.48|||||||Fisher Exact|||||||0.480
70854513|NCT03073733|141197374|SUPERIORITY|||||||0.076|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 51.5)||||||0.076
70854514|NCT03073733|141197374|SUPERIORITY|||||||0.057|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 26.1)||||||0.057
70854515|NCT03073733|141197375|SUPERIORITY|||||||0.117|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 29.0)||||||0.117
70854516|NCT03073733|141197375|SUPERIORITY|||||||0.083|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 9.5)||||||0.083
70854517|NCT03073733|141197376|SUPERIORITY|||||||0.172|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 6.7)||||||0.172
70854518|NCT03073733|141197376|SUPERIORITY|||||||0.14|||||||t-test, 1 sided|Pooled t-test (variance ratio of 3.98)||||||0.140
70854519|NCT03073733|141197377|SUPERIORITY|||||||0.011|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 5.4).||||||0.011
70854520|NCT03073733|141197378|SUPERIORITY|||||||0.0406|||||||Fisher Exact|||||||0.0406
70854521|NCT03073733|141197379|SUPERIORITY|||||||0.007|||||||Fisher Exact|||||||0.007
70854522|NCT03073733|141197380|SUPERIORITY|||||||0.026|||||||Fisher Exact|||||||0.026
70854523|NCT03073733|141197381|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.200
70854524|NCT03073733|141197382|SUPERIORITY|||||||0.03|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 22.2)||||||0.030
70854525|NCT03073733|141197382|SUPERIORITY|||||||0.033|||||||t-test, 1 sided|Pooled t-test (variance ratio of 3.3)||||||0.033
70854526|NCT03073733|141197383|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.200
70854527|NCT03073733|141197384|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.200
70854528|NCT03073733|141197385|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
70854529|NCT03073733|141197386|SUPERIORITY|||||||0.08|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 606.4)||||||0.080
70854530|NCT03073733|141197386|SUPERIORITY|||||||0.05|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 52.3)||||||0.050
70854531|NCT03073733|141197387|SUPERIORITY|||||||0.099|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 35.7)||||||0.099
70854532|NCT03073733|141197387|SUPERIORITY|||||||0.076|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 17.6)||||||0.076
70854533|NCT03073733|141197388|SUPERIORITY|||||||0.1099|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 4.5)||||||0.1099
70854534|NCT03073733|141197388|SUPERIORITY|||||||0.012|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 14.3)||||||0.012
70854535|NCT01221272|141197407|SUPERIORITY_OR_OTHER||Mixed Models Analysis|0.67||||0.29|TWO_SIDED|95.0|-0.6|1.9||The null hypothesis that ranolazine treatment had no effect on PDS would be rejected if the PDS and TPD p-values were less than 0.05 or the PDS p-value was less than 0.05/2 = 0.025.|Mixed Models Analysis|||||1.9|-0.6|0.29
70854536|NCT01221272|141197408|SUPERIORITY_OR_OTHER||Mixed Models Analysis|0.65||||0.22|TWO_SIDED|95.0|-0.4|1.7||The null hypothesis that ranolazine treatment had no effect on TPD would be rejected if the PDS and TPD p-values were less than 0.05 or the TPD p-value was less than 0.05/2 = 0.025.|Mixed Models Analysis|||||1.7|-0.4|0.22
70854537|NCT04839562|141197412|SUPERIORITY||Mean Difference (Final Values)|-4.3|||=|0.0106|TWO_SIDED|95.0|-7.7|-1.0|||t-test, 2 sided|||||-1|-7.7|=.0106
70854538|NCT04839562|141197413|SUPERIORITY||||||=|0.002|||||||Fisher Exact|||||||=.002
70854539|NCT04839562|141197414|SUPERIORITY||||||=|0.0173|||||||Fisher Exact|||||||=.0173
70943004|NCT00645099|141386240|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||< 0.0001
70854540|NCT04839562|141197415|SUPERIORITY||||||=|0.1144|||||||Fisher Exact|||||||=.1144
70943005|NCT00645099|141386241|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||<0.0001
70854541|NCT04839562|141197416|SUPERIORITY||||||=|0.0348|||||||Fisher Exact|||||||=.0348
70854542|NCT04839562|141197417|SUPERIORITY||||||=|1|||||||Fisher Exact|||||||=1
70854543|NCT04839562|141197418|SUPERIORITY||||||=|0.0173|||||||Fisher Exact|||||||=.0173
70854544|NCT04839562|141197419|SUPERIORITY||||||=|0.1864|||||||Fisher Exact|||||||=.1864
70854545|NCT04839562|141197420|SUPERIORITY||||||=|0.4173|||||||Fisher Exact|||||||=.4173
70854546|NCT04839562|141197421|SUPERIORITY||||||=|0.0343|||||||Fisher Exact|||||||=.0343
70854547|NCT04839562|141197422|SUPERIORITY||||||=|0.0636|||||||Fisher Exact|||||||=.0636
70854548|NCT04839562|141197423|SUPERIORITY||||||=|0.065|||||||Fisher Exact|||||||=.065
70854549|NCT04839562|141197424|SUPERIORITY||||||=|0.1144|||||||Fisher Exact|||||||=.1144
70854550|NCT04839562|141197425|SUPERIORITY||||||=|0.2829|||||||Fisher Exact|||||||=.2829
70854551|NCT01350544|141197446|SUPERIORITY||Odds Ratio (OR)|0.79||||0.005|TWO_SIDED|95.0|0.69|0.91||a priori threshold for significance for p \< .05|Mixed Models Analysis|||We used generalized linear mixed models predicting adherence at baseline and 1.5-, 3-, 4.5-, and 6-months post-baseline, with intervention , time, interaction between intervention and time, medical and socio-demographic covariates, and baseline viral load. Sample size was determined with a power analysis assuming .80 power and an alpha level of .05 that would allow for detection of a small-to-medium effect size in adherence between arms.||0.91|0.69|.005
70854552|NCT00538785|141197450|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.746|||||TWO_SIDED|95.0|0.344|1.586|||Guess method|Exact conditional binomial method conditioning on the total number of cases with mid-probability adjustment||Relative risk and confidence interval adjusted for the stratification factor of CHD stratum (cyanotic or other) specified on the CRF||1.586|0.344|
70854553|NCT00538785|141197451|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.495|||||TWO_SIDED|95.0|0.101|1.989|||Guess method|Exact conditional binomial method conditioning on the total number of cases with mid-probability adjustment||Relative risk and confidence interval adjusted for the stratification factor of CHD stratum (cyanotic or other) specified on the CRF||1.989|0.101|
70854554|NCT03086967|141197464|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
70854555|NCT03086967|141197465|SUPERIORITY|||||||0.133|||||||t-test, 2 sided|||||||0.133
70854556|NCT03086967|141197466|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
70854557|NCT03086967|141197467|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
70854558|NCT03086967|141197468|SUPERIORITY|||||||0.8|||||||Chi-squared|||||||0.8
70854559|NCT03086967|141197469|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
70854560|NCT03086967|141197470|SUPERIORITY|||||||0.98|||||||Chi-squared|||||||0.98
70854561|NCT03086967|141197471|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||||||0.95
70854562|NCT03086967|141197472|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
70854563|NCT03086967|141197473|SUPERIORITY|||||||0.0003|||||||t-test, 2 sided|||||||0.0003
70854564|NCT03086967|141197474|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||||||0.48
70943006|NCT00645099|141386242|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||<0.0001
70943007|NCT00645099|141386243|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||Fisher Exact|This test was interpreted at the 5% significance level (2-tailed).||||||0.0230
70854565|NCT01733212|141197525|EQUIVALENCE|Considering the null hypothesis that the number of participants who will have vomiting will be equal in the two arms, we performed this study with a significance level of 0.05% and power of 80% to prove that there is a difference in the number.||||||0.07|||||||Chi-squared|||Number of participants who had vomiting in each group is compared to the other. Two sided Chi square test was conducted, Type I error of 0.05% and power of 80% are considered.||||0.07
70854566|NCT00775203|141197526|SUPERIORITY_OR_OTHER|||||||0.0119|||||||ANCOVA|ANCOVA with treatment and study center as categorical factors and HAMD-17 baseline as covariate.||The primary null hypothesis for the HAMD-17 total score is that there is no difference between the Trazodone Contramid® OAD group and the placebo group at Week 8. A sample size of 133 in each group will have 90% power to detect a difference in the absolute mean Hamilton Rating Scale for Depression (HAMD-17) change from baseline of 3.0 units assuming that the common standard deviation is 7.5 using a two-group t-test with a 0.05 two-sided significance level.||||0.0119
70854567|NCT02486627|141197552|NON_INFERIORITY|95% CIs for the difference in cure rates were calculated using the Newcombe method with continuity correction.|Difference|-3.4|||||TWO_SIDED|95.0|-10.0|3.1||||||||3.1|-10|
70854568|NCT02486627|141197553|NON_INFERIORITY|95% CIs for the difference in cure rates were calculated using the Newcombe method with continuity correction.|Difference|11.6|||||TWO_SIDED|95.0|2.7|20.3||||||||20.3|2.7|
70954221|NCT00688870|141411075|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.91|||||TWO_SIDED|95.0|0.7|1.17|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 6B||1.17|0.70|
71118300|NCT02438683|141741577|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.0029|||||TWO_SIDED|95.0|-0.0052|-0.0007||||The covariance structure is Unstructured.||The regression model with response variable placebo-corrected change from max HR to recovery HR (ddHR) and independent variable Plasma concentration includes a fixed slope effect as well as random intercept estimates for each subject (Primary analysis).||-0.0007|-0.0052|
71118301|NCT01846299|141741652|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.78|STANDARD_ERROR_OF_MEAN|1.203||0.0111|TWO_SIDED|95.0|0.4|5.16|||Mixed Models Analysis|||||5.16|0.40|0.0111
71118302|NCT03095027|141741682|NON_INFERIORITY|The pre-specified non-inferiority margin is 0.05. With a sample size of 10, there was approximately 80% power to reject the null hypothesis of inferiority in visual acuity with assumed standard deviation of 0.0474 (one-sided alpha=0.05)|LSM Difference|0.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0||0.01||||||||0.01||
71118303|NCT05275010|141741685|EQUIVALENCE|The null hypothesis will be rejected and bioequivalence will be concluded if the bounds of the 90% CI for the geometric mean ratio of the AUC0-62 values for pertuzumab by administration using OBDS (Arm 2) relative to the handheld syringe (Arm 1) are entirely contained within standard bioequivalence margins (0.8 to 1.25).|Geometric Mean Ratio (GMR)|1.0|||||TWO_SIDED|90.0|0.93|1.08|||||GMR of test treatment group (Arm 2: PH FDC SC using OBDS) to reference treatment group (Arm 1: PH FDC SC using handheld syringe).|||1.08|0.93|
71118304|NCT05275010|141741686|EQUIVALENCE|The null hypothesis will be rejected and bioequivalence will be concluded if the bounds of the 90% CI for the geometric mean ratio of the AUC0-62 values for trastuzumab by administration using OBDS (Arm 2) relative to the handheld syringe (Arm 1) are entirely contained within standard bioequivalence margins (0.8 to 1.25).|Geometric Mean Ratio (GMR)|1.0|||||TWO_SIDED|90.0|0.93|1.09|||||GMR of test treatment group (Arm 2: PH FDC SC using OBDS) to reference treatment group (Arm 1: PH FDC SC using handheld syringe).|||1.09|0.93|
71118305|NCT05275010|141741687|EQUIVALENCE|The null hypothesis will be rejected and bioequivalence will be concluded if the bounds of the 90% CI for the geometric mean ratio of the Cmax values for pertuzumab by administration using OBDS (Arm 2) relative to the handheld syringe (Arm 1) are entirely contained within standard bioequivalence margins (0.8 to 1.25).|Geometric Mean Ratio (GMR)|1.04|||||TWO_SIDED|90.0|0.96|1.12|||||GMR of test treatment group (Arm 2: PH FDC SC using OBDS) to reference treatment group (Arm 1: PH FDC SC using handheld syringe).|||1.12|0.96|
71118306|NCT05275010|141741688|EQUIVALENCE|The null hypothesis will be rejected and bioequivalence will be concluded if the bounds of the 90% CI for the geometric mean ratio of the Cmax values for trastuzumab by administration using OBDS (Arm 2) relative to the handheld syringe (Arm 1) are entirely contained within standard bioequivalence margins (0.8 to 1.25).|Geometric Mean Ratio (GMR)|1.04|||||TWO_SIDED|90.0|0.95|1.13|||||GMR of test treatment group (Arm 2: PH FDC SC using OBDS) to reference treatment group (Arm 1: PH FDC SC using handheld syringe).|||1.13|0.95|
71118307|NCT02743949|141741744|SUPERIORITY||Wilcoxon-Mann-Whitney odds estimator|1.0584||||0.748|TWO_SIDED|97.5|0.71|1.5778||P-values were obtained using a Pearson chi-square test for each Vonoprazan treatment compared with Esomeprazole.|Wilcoxon rank-sum test|||||1.5778|0.7100|0.7480
71118308|NCT02743949|141741744|SUPERIORITY||Wilcoxon-Mann-Whitney odds estimator|1.0975||||0.5985|TWO_SIDED|97.5|0.7368|1.6349||P-values were obtained using a Pearson chi-square test for each Vonoprazan treatment compared with Esomeprazole.|Wilcoxon rank-sum test|||||1.6349|0.7368|0.5985
71118309|NCT02743949|141741745|SUPERIORITY||Miettinen-Nurminen|0.91||||0.782|TWO_SIDED|97.5|0.44|1.91||P-values were obtained using a Pearson chi-square test for each Vonoprazan treatment compared with Esomeprazole.|Pearson chi-square|||||1.91|0.44|0.782
71118310|NCT02743949|141741745|SUPERIORITY||Miettinen-Nurminen|0.96||||0.912|TWO_SIDED|97.5|0.46|2.01||P-values were obtained using a Pearson chi-square test for each Vonoprazan treatment compared with Esomeprazole.|Pearson chi-square|||||2.01|0.46|0.912
71118311|NCT03327220|141741746|SUPERIORITY||Difference in Means|1.3||||0.0841|TWO_SIDED|95.0|-0.6|3.2||p-value was calculated from a one-sided, two-sample t-test.|t-test, 1 sided|||Testing null hypothesis that true iovera° mean was greater than or equal to the true standard of care mean versus the alternative hypothesis that true iovera° mean was less than true standard of care mean.||3.2|-0.6|0.0841
71118312|NCT03327220|141741747|NON_INFERIORITY|The objective met if the t-test for non-inferiority was statistically significant using a one-sided α = 0.025 level of statistical significance.|Difference in Means|1.9|||<|0.0001|TWO_SIDED|95.0|-2.3|6.1||p-value was calculated from a one-sided, two-sample t-test.|t-test, 1 sided|||Testing null hypothesis that Standard of Care mean minus the iovera° mean was greater than or equal to non-inferiority margin of 14 versus alternative hypothesis that difference in means was less than 14.||6.1|-2.3|<0.0001
71118313|NCT03327220|141741748|SUPERIORITY||Difference in Means|0.5||||0.0946|TWO_SIDED|95.0|-0.2|1.2||p-value was calculated from a one-sided, two-sample t-test.|t-test, 1 sided|||Pain in the Past 7 days - Testing the null hypothesis that the iovera° mean was less than or equal to the Standard of Care mean versus the alternative hypothesis that the iovera° mean was greater than the Standard of Care mean.||1.2|-0.2|0.0946
70954222|NCT00688870|141411075|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.67|||||TWO_SIDED|95.0|0.55|0.82|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 9V||0.82|0.55|
71118314|NCT03327220|141741748|SUPERIORITY|Pain Right Now - Testing the null hypothesis that the iovera° mean was less than or equal to the Standard of Care mean versus the alternative hypothesis that the iovera° mean was greater than the Standard of Care mean.|Difference in Means|0.4||||0.2204|TWO_SIDED|95.0|-0.6|1.3||p-value was calculated from a one-sided, two-sample t-test,|t-test, 1 sided|||||1.3|-0.6|0.2204
71118315|NCT03327220|141741749|SUPERIORITY||Difference in Means|-0.8||||0.3231|TWO_SIDED|95.0|-4.0|2.5||p-value was calculated from a one-sided, two-sample t-test.|t-test, 1 sided|||Testing the null hypothesis that the iovera° mean was less than or equal to the Standard of Care mean versus the alternative hypothesis that the iovera° mean was greater than the Standard of Care mean.||2.5|-4.0|0.3231
71118316|NCT00523705|141741752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.57|STANDARD_ERROR_OF_MEAN|4.86||0.467|TWO_SIDED||||||Regression, Linear||estimate of main effect of treatment in a linear mixed effects model.|Pilot data were examined at treatment endpoint for change from baseline. Statistical power was very low due to the small sample size.||||0.467
71118317|NCT04392141|141741762|EQUIVALENCE|equivalence of odds of death between both groups|Odds Ratio (OR)|9.87||||0.0318|TWO_SIDED|95.0|1.16|83.89|||Fisher Exact|||||83.89|1.16|0.0318
71118318|NCT04392141|141741763|EQUIVALENCE|equivalence of SpO2 percentage between admission and discharge phases|Mean Difference (Final Values)|-5.5||||0.0001|TWO_SIDED|95.0|-7.03|-3.96|||t-test, 2 sided|Paired T-test||Statistical comparison of SpO2 (%) between admission and discharge times in standard treatment group||-3.96|-7.03|0.0001
71118319|NCT04392141|141741763|EQUIVALENCE|equivalence of SpO2 percentage between admission and discharge phases|Mean Difference (Final Values)|-2.55||||0.0001|TWO_SIDED|95.0|-3.28|-1.81|||t-test, 2 sided|Paired T-test||Statistical comparison of SpO2 % between admission and discharge times in the Colchicine and Herbal Phenolic Monoterpene Fractions treatment||-1.81|-3.28|0.0001
71118320|NCT04392141|141741764|EQUIVALENCE|equivalence of means of the length of hospitalization between both groups|Mean Difference (Final Values)|2.22||||0.0001|TWO_SIDED|95.0|1.63|2.8|||Wilcoxon (Mann-Whitney)|||||2.80|1.63|0.0001
71118321|NCT04392141|141741765|EQUIVALENCE|equivalence of mean of lymphocytes count between admission and discharge phases|Mean Difference (Final Values)|0.02||||0.8|TWO_SIDED|95.0|-0.136|0.176|||t-test, 2 sided|Paired T-test||Statistical comparison of lymphocytes count between admission and discharge times in standard treatment||0.176|-0.136|0.80
71118322|NCT04392141|141741765|EQUIVALENCE|equivalence of mean of lymphocytes count between admission and discharge phases|Mean Difference (Final Values)|-0.43||||0.0001|TWO_SIDED|95.0|-0.63|-0.23|||t-test, 2 sided|Paired T-test||Statistical comparison of lymphocytes count between admission and discharge times in Colchicine and Herbal Phenolic Monoterpene Fractions treatment||-0.23|-0.63|0.0001
71118323|NCT04392141|141741766|EQUIVALENCE|equivalence of mean of LDH between admission and discharge phases|Mean Difference (Final Values)|-26.06||||0.602|TWO_SIDED|95.0|-124.76|72.64|||t-test, 2 sided|Paired T-test||Statistical comparison of LDH between admission and discharge times in standard treatment||72.64|-124.76|0.602
71118324|NCT04392141|141741766|EQUIVALENCE|equivalence of mean of LDH between admission and discharge phases|Mean Difference (Final Values)|137.33||||0.006|TWO_SIDED|95.0|38.19|236.46|||t-test, 2 sided|Paired T-test||Statistical comparison of LDH between admission and discharge times in Colchicine and Herbal Phenolic Monoterpene Fractions treatment||236.46|38.19|0.006
71118325|NCT03622112|141741792|SUPERIORITY||Mean Difference (Final Values)|-0.036||||0.437|TWO_SIDED|95.0|-0.126|0.054|||Mixed Models Analysis|||||0.054|-0.126|0.437
71118326|NCT03622112|141741792|SUPERIORITY||Mean Difference (Final Values)|-0.054||||0.236|TWO_SIDED|95.0|-0.143|0.035|||Mixed Models Analysis|||||0.035|-0.143|0.236
71118327|NCT03622112|141741792|SUPERIORITY||Mean Difference (Final Values)|0.039||||0.389|TWO_SIDED|95.0|-0.05|0.128|||Mixed Models Analysis|||||0.128|-0.050|0.389
71118328|NCT03622112|141741792|SUPERIORITY||Mean Difference (Final Values)|0.076||||0.094|TWO_SIDED|95.0|-0.013|0.165|||Mixed Models Analysis|||||0.165|-0.013|0.094
71118329|NCT03622112|141741792|SUPERIORITY||Mean Difference (Final Values)|0.082||||0.06|TWO_SIDED|95.0|-0.003|0.167|||Mixed Models Analysis|||||0.167|-0.003|0.060
71118330|NCT03622112|141741792|SUPERIORITY||Mean Difference (Final Values)|0.111||||0.014|TWO_SIDED|95.0|0.023|0.199|||Mixed Models Analysis|||||0.199|0.023|0.014
71118331|NCT03622112|141741793|SUPERIORITY||Mean Difference (Final Values)|0.029||||0.463|TWO_SIDED|95.0|-0.048|0.105|||Mixed Models Analysis|||Week 2||0.105|-0.048|0.463
71118332|NCT03622112|141741793|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.576|TWO_SIDED|95.0|-0.055|0.098|||Mixed Models Analysis|||Week 2||0.098|-0.055|0.576
71118333|NCT03622112|141741793|SUPERIORITY||Mean Difference (Final Values)|0.078||||0.047|TWO_SIDED|95.0|0.001|0.154|||Mixed Models Analysis|||Week 2||0.154|0.001|0.047
71118334|NCT03622112|141741793|SUPERIORITY||Mean Difference (Final Values)|0.102||||0.009|TWO_SIDED|95.0|0.025|0.179|||Mixed Models Analysis|||Week 2||0.179|0.025|0.009
71118335|NCT03622112|141741793|SUPERIORITY||Mean Difference (Final Values)|0.104||||0.006|TWO_SIDED|95.0|0.031|0.178|||Mixed Models Analysis|||Week 2||0.178|0.031|0.006
71118336|NCT03622112|141741793|SUPERIORITY||Mean Difference (Final Values)|0.118||||0.003|TWO_SIDED|95.0|0.041|0.194|||Mixed Models Analysis|||Week 2||0.194|0.041|0.003
71118337|NCT03622112|141741793|SUPERIORITY||Mean Difference (Final Values)|0.018||||0.685|TWO_SIDED|95.0|-0.068|0.103|||Mixed Models Analysis|||Week 4||0.103|-0.068|0.685
71118338|NCT03622112|141741793|SUPERIORITY||Mean Difference (Final Values)|0.059||||0.176|TWO_SIDED|95.0|-0.026|0.144|||Mixed Models Analysis|||Week 4||0.144|-0.026|0.176
71118339|NCT03622112|141741793|SUPERIORITY||Mean Difference (Final Values)|0.098||||0.024|TWO_SIDED|95.0|0.013|0.183|||Mixed Models Analysis|||Week 4||0.183|0.013|0.024
71118340|NCT03622112|141741793|SUPERIORITY||Mean Difference (Final Values)|0.106||||0.014|TWO_SIDED|95.0|0.021|0.191|||Mixed Models Analysis|||Week 4||0.191|0.021|0.014
71118341|NCT03622112|141741793|SUPERIORITY||Mean Difference (Final Values)|0.114||||0.006|TWO_SIDED|95.0|0.032|0.196|||Mixed Models Analysis|||Week 4||0.196|0.032|0.006
71118342|NCT03622112|141741793|SUPERIORITY||Mean Difference (Final Values)|0.165|||<|0.001|TWO_SIDED|95.0|0.081|0.249|||Mixed Models Analysis|||Week 4||0.249|0.081|< 0.001
71118343|NCT03622112|141741793|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.707|TWO_SIDED|95.0|-0.072|0.106|||Mixed Models Analysis|||Week 8||0.106|-0.072|0.707
70943008|NCT00645099|141386244|NON_INFERIORITY_OR_EQUIVALENCE|Testing non-inferiority of the paliperidone ER treatment group compared to the olanzapine treatment group, with regard to change versus baseline at end point of the total PANSS was done by means of Schuirmann's test. A difference of 6 points in change versus baseline on the total PANSS was considered to be a minimum clinically relevant difference.The null hypothesis is that there is no difference between paliperidone and olanzapine in change in TG:HDL ratio from baseline to endpoint.||||||0.0242||95.0|||||Schuirmann|The null hypothesis of non-equivalence was rejected and equivalence to within the specified equivalence bounds could be claimed.||||||0.0242
70943009|NCT00645099|141386244|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||<0.0001
70943010|NCT00645099|141386244|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||<0.0001
70943011|NCT01201915|141386245|SUPERIORITY_OR_OTHER|||||||0.8463|||||||1-sided exact binomial test|||The null hypothesis was that percentage of participants with complete histologic clearance was 50% or less.||||0.8463
70943012|NCT01201915|141386245|SUPERIORITY_OR_OTHER|||||||0.9668|||||||1-sided exact binomial test|||The null hypothesis was that percentage of participants with complete histologic clearance was 30% or less.||||0.9668
70943013|NCT01201915|141386245|SUPERIORITY_OR_OTHER|||||||0.7878|||||||1-sided exact binomial test|||The null hypothesis was that percentage of participants with complete histologic clearance was 50% or less.||||0.7878
70943014|NCT00663923|141386270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.1|<|0.05|TWO_SIDED|95.0|-0.62|-0.001||two - tailed p value \<0.05 were considered statistically significant.|t-test, 2 sided|in this study degrees of freedom is sample size - 1||||-.001|-.62|<0.05
70943015|NCT00230971|141386304|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|1.6||||||95.0|-6.4|9.6|||t-test, 1 sided||Estimates of the difference, CI and hypothesis tests are weighted by using minimum risk weights.|||9.6|-6.4|
70943016|NCT00230971|141386305|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|1.8||||0.001||95.0|-8.8|12.5|||t-test, 1 sided||Estimates of the difference, CI and hypothesis tests are weighted by using minimum risk weights.|||12.5|-8.8|0.001
70943017|NCT00230971|141386306|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|2.7||||||95.0|-7.9|13.3|||t-test, 1 sided||Estimates of the difference, CI and hypothesis tests are weighted by using minimum risk weights.|Group comparison of eradication + presumed eradication||13.3|-7.9|
70943018|NCT00230971|141386307|SUPERIORITY_OR_OTHER|||||||0.75|||||||ANOVA|Treatment as a factor||Overall inpatient hospitalization||||0.750
70943019|NCT00230971|141386307|SUPERIORITY_OR_OTHER|||||||0.655|||||||ANOVA|Treatment as a factor||Primary inpatient hospitalization||||0.655
70943020|NCT00230971|141386307|SUPERIORITY_OR_OTHER|||||||0.191|||||||ANOVA|Treatment as a factor||ICU treatment||||0.191
70943021|NCT00230971|141386307|SUPERIORITY_OR_OTHER|||||||0.717|||||||ANOVA|Treatment as a factor||Inpatient hospitalization, non-ICU||||0.717
70943022|NCT01960348|141386316|SUPERIORITY||Least Squares Mean Difference|-33.99|STANDARD_ERROR_OF_MEAN|2.974|<|1e-07|TWO_SIDED|95.0|-39.86|-28.13||P=9.262E-24|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in mNIS+7. The model includes baseline mNIS+7 score as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||-28.13|-39.86|<0.0000001
70943023|NCT01960348|141386317|SUPERIORITY||Least Squares Mean Difference|-21.1|STANDARD_ERROR_OF_MEAN|3.1|<|1e-07|TWO_SIDED|95.0|-27.2|-15.0||P=1.103E-10|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in Norfolk QOL-DN total score. The model includes baseline Norfolk QOL-DN score as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, baseline NIS, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||-15.0|-27.2|<0.0000001
70943024|NCT01960348|141386318|SUPERIORITY||Least Squares Mean Difference|-17.87|STANDARD_ERROR_OF_MEAN|2.254|<|1e-07|TWO_SIDED|95.0|-22.32|-13.43||P=1.404E-13|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in NIS-W. The model includes baseline NIS-W score as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||-13.43|-22.32|<0.0000001
71118344|NCT03622112|141741793|SUPERIORITY||Mean Difference (Final Values)|0.005||||0.904|TWO_SIDED|95.0|-0.083|0.094|||Mixed Models Analysis|||Week 8||0.094|-0.083|0.904
71118345|NCT03622112|141741793|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.121|TWO_SIDED|95.0|-0.018|0.157|||Mixed Models Analysis|||Week 8||0.157|-0.018|0.121
70943025|NCT01960348|141386319|SUPERIORITY||Least Squares Mean Difference|9.0|STANDARD_ERROR_OF_MEAN|1.01|<|1e-07|TWO_SIDED|95.0|7.0|10.9||P=4.066E-16|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in R-ODS value. The model includes baseline R-ODS score as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, baseline NIS, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||10.9|7.0|<0.0000001
70943026|NCT01960348|141386320|SUPERIORITY||Least Squares Mean Difference|0.311|STANDARD_ERROR_OF_MEAN|0.0415|<|1e-07|TWO_SIDED|95.0|0.23|0.393||P=1.875E-12|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in 10-meter walk test result. The model includes baseline 10-meter walk test result as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, baseline NIS, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||0.393|0.230|<0.0000001
71118346|NCT03622112|141741793|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.026|TWO_SIDED|95.0|0.012|0.188|||Mixed Models Analysis|||Week 8||0.188|0.012|0.026
70943027|NCT01960348|141386321|SUPERIORITY||Least Squares Mean Difference|115.7|STANDARD_ERROR_OF_MEAN|16.91|<|1e-07|TWO_SIDED|95.0|82.4|149.0||P=8.832E-11|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in mBMI. The model includes baseline mBMI as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, baseline NIS, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||149.0|82.4|<0.0000001
70871982|NCT03919799|141229332|SUPERIORITY|The LOCF imputation was followed by logistic regression analysis. Comparison analysis between belumosudil dose regimen and placebo was performed using a logistic regression analysis with treatment in the model.|Odds Ratio (OR)|0.39||||0.3078|TWO_SIDED|95.0|0.07|2.35||Threshold for significance at 0.05 level.|Regression, Logistic|||Belumosudil 200 mg BID versus Placebo||2.35|0.07|0.3078
70943028|NCT01960348|141386322|SUPERIORITY||Least Squares Mean Difference|-7.53|STANDARD_ERROR_OF_MEAN|2.213||0.0008|TWO_SIDED|95.0|-11.89|-3.16|||Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in COMPASS-31 total score. The model includes baseline COMPASS-31 score as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, baseline NIS, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||-3.16|-11.89|0.0008
70943029|NCT01580995|141386323|SUPERIORITY_OR_OTHER|||||||0.05|||||||Fisher Exact|||||||0.05
70943030|NCT05109117|141386324|SUPERIORITY||Adjusted Mean Difference|2.8|||<|0.0001|TWO_SIDED|95.0|1.7|3.9|||ANCOVA|Analysis of Covariance (ANCOVA) model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 2 hours post-treatment||3.9|1.7|<0.0001
70943031|NCT05109117|141386324|SUPERIORITY||Adjusted Mean Difference|1.5||||0.0077|TWO_SIDED|95.0|0.4|2.7|||ANCOVA|ANCOVA model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 4 hours post-treatment||2.7|0.4|0.0077
70943032|NCT05109117|141386324|SUPERIORITY||Adjusted Mean Difference|1.8||||0.0019|TWO_SIDED|95.0|0.7|2.9|||ANCOVA|ANCOVA model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 6 hours post-treatment||2.9|0.7|0.0019
70943033|NCT05109117|141386324|SUPERIORITY||Adjusted Mean Difference|1.0||||0.0707|TWO_SIDED|95.0|-0.1|2.2|||ANCOVA|ANCOVA model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 8 hours post-treatment||2.2|-0.1|0.0707
70954223|NCT00688870|141411075|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.84|||||TWO_SIDED|95.0|0.67|1.06|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 14||1.06|0.67|
71118347|NCT03622112|141741793|SUPERIORITY||Mean Difference (Final Values)|0.139||||0.001|TWO_SIDED|95.0|0.055|0.224|||Mixed Models Analysis|||Week 8||0.224|0.055|0.001
71118348|NCT03622112|141741793|SUPERIORITY||Mean Difference (Final Values)|0.122||||0.006|TWO_SIDED|95.0|0.035|0.209|||Mixed Models Analysis|||Week 8||0.209|0.035|0.006
71118349|NCT03622112|141741793|SUPERIORITY||Mean Difference (Final Values)|0.007||||0.856|TWO_SIDED|95.0|-0.068|0.081|||Mixed Models Analysis|||Treatment period average||0.081|-0.068|0.856
71118350|NCT03622112|141741793|SUPERIORITY||Mean Difference (Final Values)|0.008||||0.832|TWO_SIDED|95.0|-0.066|0.082|||Mixed Models Analysis|||Treatment period average||0.082|-0.066|0.832
71118351|NCT03622112|141741793|SUPERIORITY||Mean Difference (Final Values)|0.071||||0.06|TWO_SIDED|95.0|-0.003|0.145|||Mixed Models Analysis|||Treatment period average||0.145|-0.003|0.060
71118352|NCT03622112|141741793|SUPERIORITY||Mean Difference (Final Values)|0.096||||0.011|TWO_SIDED|95.0|0.022|0.17|||Mixed Models Analysis|||Treatment period average||0.170|0.022|0.011
71118353|NCT03622112|141741793|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.003|TWO_SIDED|95.0|0.039|0.181|||Mixed Models Analysis|||Treatment period average||0.181|0.039|0.003
71118354|NCT03622112|141741793|SUPERIORITY||Mean Difference (Final Values)|0.129|||<|0.001|TWO_SIDED|95.0|0.055|0.202|||Mixed Models Analysis|||Treatment period average||0.202|0.055|<0.001
71118355|NCT03622112|141741794|SUPERIORITY||Mean Difference (Final Values)|0.936||||0.322|TWO_SIDED|95.0|0.822|1.067|||Mixed Models Analysis|||Week 2||1.067|0.822|0.322
71118356|NCT03622112|141741794|SUPERIORITY||Mean Difference (Final Values)|0.876||||0.047|TWO_SIDED|95.0|0.768|0.999|||Mixed Models Analysis|||Week 2||0.999|0.768|0.047
71118357|NCT03622112|141741794|SUPERIORITY||Mean Difference (Final Values)|0.842||||0.01|TWO_SIDED|95.0|0.739|0.959|||Mixed Models Analysis|||Week 2||0.959|0.739|0.010
71118358|NCT03622112|141741794|SUPERIORITY||Mean Difference (Final Values)|0.825||||0.004|TWO_SIDED|95.0|0.724|0.941|||Mixed Models Analysis|||Week 2||0.941|0.724|0.004
71118359|NCT03622112|141741794|SUPERIORITY||Mean Difference (Final Values)|0.687|||<|0.001|TWO_SIDED|95.0|0.606|0.779|||Mixed Models Analysis|||Week 2||0.779|0.606|<0.001
71118360|NCT03622112|141741794|SUPERIORITY||Mean Difference (Final Values)|0.63|||<|0.001|TWO_SIDED|95.0|0.553|0.719|||Mixed Models Analysis|||Week 2||0.719|0.553|<0.001
71118361|NCT03622112|141741794|SUPERIORITY||Mean Difference (Final Values)|0.931||||0.329|TWO_SIDED|95.0|0.805|1.076|||Mixed Models Analysis|||Week 4||1.076|0.805|0.329
71118362|NCT03622112|141741794|SUPERIORITY||Mean Difference (Final Values)|0.911||||0.203|TWO_SIDED|95.0|0.789|1.052|||Mixed Models Analysis|||Week 4||1.052|0.789|0.203
71118363|NCT03622112|141741794|SUPERIORITY||Mean Difference (Final Values)|0.923||||0.273|TWO_SIDED|95.0|0.8|1.065|||Mixed Models Analysis|||Week 4||1.065|0.800|0.273
71118364|NCT03622112|141741794|SUPERIORITY||Mean Difference (Final Values)|0.846||||0.023|TWO_SIDED|95.0|0.734|0.977|||Mixed Models Analysis|||Week 4||0.977|0.734|0.023
71118365|NCT03622112|141741794|SUPERIORITY||Mean Difference (Final Values)|0.742|||<|0.001|TWO_SIDED|95.0|0.646|0.852|||Mixed Models Analysis|||Week 4||0.852|0.646|<0.001
71118366|NCT03622112|141741794|SUPERIORITY||Mean Difference (Final Values)|0.703|||<|0.001|TWO_SIDED|95.0|0.609|0.81|||Mixed Models Analysis|||Week 4||0.810|0.609|<0.001
71118367|NCT03622112|141741794|SUPERIORITY||Mean Difference (Final Values)|0.917||||0.283|TWO_SIDED|95.0|0.783|1.074|||Mixed Models Analysis|||Week 8||1.074|0.783|0.283
71118368|NCT03622112|141741794|SUPERIORITY||Mean Difference (Final Values)|0.933||||0.386|TWO_SIDED|95.0|0.797|1.092|||Mixed Models Analysis|||Week 8||1.092|0.797|0.386
70943034|NCT02853305|141386390|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0033|TWO_SIDED|95.0|0.65|0.93|||Stratified Log-Rank|The treatment difference in PFS was assessed by the stratified log-rank test.||PFS in all participants of the pembro combo arm was compared to PFS in all participants of the chemo arm to address the first primary hypothesis (superiority to chemo). The hazard ratio (HR) and its 95% confidence interval (CI) were estimated using a stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||0.93|0.65|0.0033
70854569|NCT00445588|141197572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.4|TWO_SIDED|95.0|0.6|1.3||cox regression model was used to estimate the HR of death compared to NABTT historical control with same histology, adjusted for age, KPS, and surgical procedure|Regression, Cox|cox regression model used to estimate the HR of death compared to NABTT historical control same histology, adjusted for age, KPS, surgical procedure||The overall failure rate will be estimated by dividing the number of events (death) with the total exposure time in the study cohort. 95% confidence intervals and median time of survival will be calculated using standard methods.||1.3|0.6|0.4
70854570|NCT03554486|141197574|OTHER|||||||0.051|||||||t-test, 2 sided|||||||0.051
71118369|NCT03622112|141741794|SUPERIORITY||Mean Difference (Final Values)|0.886||||0.126|TWO_SIDED|95.0|0.758|1.035|||Mixed Models Analysis|||Week 8||1.035|0.758|0.126
71118370|NCT03622112|141741794|SUPERIORITY||Mean Difference (Final Values)|0.855||||0.05|TWO_SIDED|95.0|0.731|1.0|||Mixed Models Analysis|||Week 8||1.000|0.731|0.050
71118371|NCT03622112|141741794|SUPERIORITY||Mean Difference (Final Values)|0.723|||<|0.001|TWO_SIDED|95.0|0.623|0.84|||Mixed Models Analysis|||Week 8||0.840|0.623|<0.001
71118372|NCT03622112|141741794|SUPERIORITY||Mean Difference (Final Values)|0.642|||<|0.001|TWO_SIDED|95.0|0.55|0.749|||Mixed Models Analysis|||Week 8||0.749|0.550|<0.001
71118373|NCT03622112|141741794|SUPERIORITY||Mean Difference (Final Values)|0.927||||0.359|TWO_SIDED|95.0|0.789|1.09|||Mixed Models Analysis|||Week 12||1.090|0.789|0.359
71118374|NCT03622112|141741794|SUPERIORITY||Mean Difference (Final Values)|0.953||||0.556|TWO_SIDED|95.0|0.813|1.118|||Mixed Models Analysis|||Week 12||1.118|0.813|0.556
71118375|NCT03622112|141741794|SUPERIORITY||Mean Difference (Final Values)|0.869||||0.084|TWO_SIDED|95.0|0.742|1.019|||Mixed Models Analysis|||Week 12||1.019|0.742|0.084
71118376|NCT03622112|141741794|SUPERIORITY||Mean Difference (Final Values)|0.813||||0.011|TWO_SIDED|95.0|0.693|0.953|||Mixed Models Analysis|||Week 12||0.953|0.693|0.011
71118377|NCT03622112|141741794|SUPERIORITY||Mean Difference (Final Values)|0.65|||<|0.001|TWO_SIDED|95.0|0.559|0.757|||Mixed Models Analysis|||Week 12||0.757|0.559|<0.001
71118378|NCT03622112|141741794|SUPERIORITY||Mean Difference (Final Values)|0.623|||<|0.001|TWO_SIDED|95.0|0.533|0.729|||Mixed Models Analysis|||Week 12||0.729|0.533|<0.001
71118379|NCT03622112|141741794|SUPERIORITY||Mean Difference (Final Values)|0.928||||0.231|TWO_SIDED|95.0|0.821|1.049|||Mixed Models Analysis|||Treatment period average||1.049|0.821|0.231
71118380|NCT03622112|141741794|SUPERIORITY||Mean Difference (Final Values)|0.918||||0.17|TWO_SIDED|95.0|0.812|1.037|||Mixed Models Analysis|||Treatment period average||1.037|0.812|0.170
71118381|NCT03622112|141741794|SUPERIORITY||Mean Difference (Final Values)|0.879||||0.039|TWO_SIDED|95.0|0.778|0.994|||Mixed Models Analysis|||Treatment period average||0.994|0.778|0.039
71118382|NCT03622112|141741794|SUPERIORITY||Mean Difference (Final Values)|0.835||||0.004|TWO_SIDED|95.0|0.739|0.943|||Mixed Models Analysis|||Treatment period average||0.943|0.739|0.004
71118383|NCT03622112|141741794|SUPERIORITY||Mean Difference (Final Values)|0.7|||<|0.001|TWO_SIDED|95.0|0.622|0.787|||Mixed Models Analysis|||Treatment period average||0.787|0.622|<0.001
71118384|NCT03622112|141741794|SUPERIORITY||Mean Difference (Final Values)|0.649|||<|0.001|TWO_SIDED|95.0|0.575|0.732|||Mixed Models Analysis|||Treatment period average||0.732|0.575|<0.001
71118385|NCT03622112|141741795|SUPERIORITY||Mean Difference (Final Values)|-0.034||||0.519|TWO_SIDED|95.0|-0.139|0.07|||Mixed Models Analysis|||Week 12||0.070|-0.139|0.519
71118386|NCT03622112|141741795|SUPERIORITY||Mean Difference (Final Values)|-0.078||||0.141|TWO_SIDED|95.0|-0.181|0.026|||Mixed Models Analysis|||Week 12||0.026|-0.181|0.141
71118387|NCT03622112|141741795|SUPERIORITY||Mean Difference (Final Values)|0.015||||0.772|TWO_SIDED|95.0|-0.088|0.119|||Mixed Models Analysis|||Week 12||0.119|-0.088|0.772
71118388|NCT03622112|141741795|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.27|TWO_SIDED|95.0|-0.045|0.162|||Mixed Models Analysis|||Week 12||0.162|-0.045|0.270
71118389|NCT03622112|141741795|SUPERIORITY||Mean Difference (Final Values)|0.027||||0.592|TWO_SIDED|95.0|-0.072|0.126|||Mixed Models Analysis|||Week 12||0.126|-0.072|0.592
71118390|NCT03622112|141741795|SUPERIORITY||Mean Difference (Final Values)|0.057||||0.275|TWO_SIDED|95.0|-0.045|0.158|||Mixed Models Analysis|||Week 12||0.158|-0.045|0.275
71118391|NCT03622112|141741795|SUPERIORITY||Mean Difference (Final Values)|-0.002||||0.963|TWO_SIDED|95.0|-0.087|0.083|||Mixed Models Analysis|||Treatment period average||0.083|-0.087|0.963
71118392|NCT03622112|141741795|SUPERIORITY||Mean Difference (Final Values)|-0.027||||0.533|TWO_SIDED|95.0|-0.112|0.058|||Mixed Models Analysis|||Treatment period average||0.058|-0.112|0.533
71118393|NCT03622112|141741795|SUPERIORITY||Mean Difference (Final Values)|0.041||||0.342|TWO_SIDED|95.0|-0.044|0.126|||Mixed Models Analysis|||Treatment period average||0.126|-0.044|0.342
71118394|NCT03622112|141741795|SUPERIORITY||Mean Difference (Final Values)|0.081||||0.061|TWO_SIDED|95.0|-0.004|0.165|||Mixed Models Analysis|||Treatment period average||0.165|-0.004|0.061
71118395|NCT03622112|141741795|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.278|TWO_SIDED|95.0|-0.037|0.127|||Mixed Models Analysis|||Treatment period average||0.127|-0.037|0.278
71118396|NCT03622112|141741795|SUPERIORITY||Mean Difference (Final Values)|0.075||||0.079|TWO_SIDED|95.0|-0.009|0.159|||Mixed Models Analysis|||Treatment period average||0.159|-0.009|0.079
71118397|NCT03622112|141741796|SUPERIORITY||Mean Difference (Final Values)|-0.153||||0.088|TWO_SIDED|95.0|-0.328|0.023|||Mixed Models Analysis|||Week 12||0.023|-0.328|0.088
71118398|NCT03622112|141741796|SUPERIORITY||Mean Difference (Final Values)|-0.257||||0.004|TWO_SIDED|95.0|-0.43|-0.084|||Mixed Models Analysis|||Week 12||-0.084|-0.430|0.004
71118399|NCT03622112|141741796|SUPERIORITY||Mean Difference (Final Values)|-0.221||||0.012|TWO_SIDED|95.0|-0.393|-0.049|||Mixed Models Analysis|||Week 12||-0.049|-0.393|0.012
71118400|NCT03622112|141741796|SUPERIORITY||Mean Difference (Final Values)|-0.193||||0.029|TWO_SIDED|95.0|-0.366|-0.02|||Mixed Models Analysis|||Week 12||-0.020|-0.366|0.029
70943035|NCT02853305|141386391|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0407|TWO_SIDED|95.0|0.72|1.02|||Stratified Log-Rank|The treatment difference in OS was assessed by the stratified log-rank test.||OS in all participants of the pembro combo arm was compared to OS in all participants of the chemo arm to address the second primary hypothesis (superiority to chemo). The HR and its 95% CI were estimated using a stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||1.02|0.72|0.0407
70854571|NCT03554486|141197575|OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
70854572|NCT03554486|141197576|OTHER|||||||0.74|||||||t-test, 2 sided|||||||0.74
71118401|NCT03622112|141741796|SUPERIORITY||Mean Difference (Final Values)|-0.269||||0.001|TWO_SIDED|95.0|-0.434|-0.104|||Mixed Models Analysis|||Week 12||-0.104|-0.434|0.001
71118402|NCT03622112|141741796|SUPERIORITY||Mean Difference (Final Values)|-0.223||||0.01|TWO_SIDED|95.0|-0.393|-0.054|||Mixed Models Analysis|||Week 12||-0.054|-0.393|0.010
71118403|NCT03622112|141741796|SUPERIORITY||Mean Difference (Final Values)|-0.125||||0.055|TWO_SIDED|95.0|-0.253|0.003|||Mixed Models Analysis|||Treatment period average||0.003|-0.253|0.055
70854573|NCT01738477|141197594|NON_INFERIORITY|To assess the non-inferiority of the second dose of Boostrix (Boostrix 2 Group) minus first dose of Boostrix (Boostrix 1 Group) for anti-diphtheria. Objective of non-inferiority was considered to be met if the lower limit (LL) of the 95% confidence interval (CI) was greater than, or equal to -10%.|Mean Difference (Final Values)|0.0||||||95.0|-3.25|9.95||||||Non-inferiority in terms of seroprotection rates to diphtheria.||9.95|-3.25|
71118404|NCT03622112|141741796|SUPERIORITY||Mean Difference (Final Values)|-0.141||||0.029|TWO_SIDED|95.0|-0.268|-0.014|||Mixed Models Analysis|||Treatment period average||-0.014|-0.268|0.029
71118405|NCT03622112|141741796|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.044|TWO_SIDED|95.0|-0.257|-0.003|||Mixed Models Analysis|||Treatment period average||-0.003|-0.257|0.044
71118406|NCT03622112|141741796|SUPERIORITY||Mean Difference (Final Values)|-0.201||||0.002|TWO_SIDED|95.0|-0.328|-0.074|||Mixed Models Analysis|||Treatment period average||-0.074|-0.328|0.002
71118407|NCT03622112|141741796|SUPERIORITY||Mean Difference (Final Values)|-0.217|||<|0.001|TWO_SIDED|95.0|-0.339|-0.094|||Mixed Models Analysis|||Treatment period average||-0.094|-0.339|<0.001
71118408|NCT03622112|141741796|SUPERIORITY||Mean Difference (Final Values)|-0.179||||0.005|TWO_SIDED|95.0|-0.305|-0.053|||Mixed Models Analysis|||Treatment period average||-0.053|-0.305|0.005
71118409|NCT03622112|141741797|SUPERIORITY||Mean Difference (Final Values)|7.664||||0.097|TWO_SIDED|95.0|-1.403|16.73|||Mixed Models Analysis|||Treatment period average||16.730|-1.403|0.097
71118410|NCT03622112|141741797|SUPERIORITY||Mean Difference (Final Values)|5.981||||0.19|TWO_SIDED|95.0|-2.98|14.941|||Mixed Models Analysis|||Treatment period average||14.941|-2.980|0.190
71118411|NCT03622112|141741797|SUPERIORITY||Mean Difference (Final Values)|9.123||||0.045|TWO_SIDED|95.0|0.195|18.052|||Mixed Models Analysis|||Treatment period average||18.052|0.195|0.045
71118412|NCT03622112|141741797|SUPERIORITY||Mean Difference (Final Values)|15.444|||<|0.001|TWO_SIDED|95.0|6.443|24.445|||Mixed Models Analysis|||Treatment period average||24.445|6.443|<0.001
71118413|NCT03622112|141741797|SUPERIORITY||Mean Difference (Final Values)|16.599|||<|0.001|TWO_SIDED|95.0|8.031|25.167|||Mixed Models Analysis|||Treatment period average||25.167|8.031|<0.001
71118414|NCT03622112|141741797|SUPERIORITY||Mean Difference (Final Values)|10.491||||0.019|TWO_SIDED|95.0|1.726|19.256|||Mixed Models Analysis|||Treatment period average||19.256|1.726|0.019
71118415|NCT03622112|141741798|SUPERIORITY||Mean Difference (Final Values)|2.398||||0.597|TWO_SIDED|95.0|-6.494|11.29|||Mixed Models Analysis|||Treatment period average||11.290|-6.494|0.597
71118416|NCT03622112|141741798|SUPERIORITY||Mean Difference (Final Values)|2.162||||0.629|TWO_SIDED|95.0|-6.623|10.948|||Mixed Models Analysis|||Treatment period average||10.948|-6.623|0.629
71118417|NCT03622112|141741798|SUPERIORITY||Mean Difference (Final Values)|3.833||||0.389|TWO_SIDED|95.0|-4.907|12.573|||Mixed Models Analysis|||Treatment period average||12.573|-4.907|0.389
71118418|NCT03622112|141741798|SUPERIORITY||Mean Difference (Final Values)|10.258||||0.022|TWO_SIDED|95.0|1.456|19.059|||Mixed Models Analysis|||Treatment period average||19.059|1.456|0.022
71118419|NCT03622112|141741798|SUPERIORITY||Mean Difference (Final Values)|11.994||||0.005|TWO_SIDED|95.0|3.571|20.417|||Mixed Models Analysis|||Treatment period average||20.417|3.571|0.005
70943036|NCT02853305|141386392|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.77|1.32||No formal hypothesis testing was performed.||||OS in CPS≥10 participants of the pembro arm was compared to OS in CPS≥10 participants of the chemo arm. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) at baseline.||1.32|0.77|
70943037|NCT02853305|141386393|OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.77|1.11||No formal hypothesis testing was performed.||||OS in all participants of the pembro arm was compared to OS in all participants of the chemo arm. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||1.11|0.77|
70943038|NCT02853305|141386394|OTHER||Hazard Ratio (HR)|1.32|||||TWO_SIDED|95.0|1.09|1.58||No formal hypothesis testing was performed.||||PFS in all participants of the pembro arm was compared to PFS in all participants of the chemo arm. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||1.58|1.09|
70943039|NCT02853305|141386397|OTHER||Difference in Percentage|9.8|||||TWO_SIDED|95.0|2.4|17.1||No formal hypothesis testing was performed.||||ORR in participants of the pembro combo arm was compared to ORR in participants of the chemo arm. The comparison was based on the Miettinen \& Nurminen method stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||17.1|2.4|
70943040|NCT02853305|141386399|OTHER||Difference in Percentage|4.5|||||TWO_SIDED|95.0|-1.6|10.6||No formal hypothesis testing was performed.||||DCR in participants of the pembro combo arm was compared to DCR in participants of the chemo arm based on the Miettinen \& Nurminen method stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||10.6|-1.6|
70943041|NCT02853305|141386400|SUPERIORITY||Difference in Percentage|-14.8|||||TWO_SIDED|95.0|-22.0|-7.4||No formal hypothesis testing was performed.||||ORR in participants of the pembro arm was compared to ORR in participants of the chemo arm. The comparison was based on the Miettinen \& Nurminen method stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||-7.4|-22.0|
70943042|NCT02853305|141386402|OTHER||Difference in Percentage|-28.9|||||TWO_SIDED|95.0|-35.9|-21.6||No formal hypothesis testing was performed.||||DCR in participants of the pembro arm was compared to DCR in participants of the chemo arm based on the Miettinen \& Nurminen method stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||-21.6|-35.9|
70943043|NCT02853305|141386406|OTHER||Difference in LS Means|2.68|||||TWO_SIDED|95.0|-0.76|6.12||No formal hypothesis testing was performed.||||Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro combo arm and the chemo arm. Comparison based on constrained longitudinal data analysis (cLDA) model with GHS/QoL score as response variable, and with treatment by study visit interactions and stratification factors (investigator's choice of chemotherapy \[cisplatin or carboplatin\] and PD-L1 status \[CPS\<10 vs. CPS≥10\]) at baseline as covariates.||6.12|-0.76|
70943044|NCT02853305|141386407|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.62|1.0||No formal hypothesis testing was performed.||||TTD in GHS/QoL combined score was compared between all participants of the pembro combo arm and the chemo arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||1.00|0.62|
70943045|NCT02853305|141386408|OTHER||Difference in LS Means|-0.94|||||TWO_SIDED|95.0|-5.06|3.18||No formal hypothesis testing was performed.||||Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro arm and the chemo arm. Comparison based on cLDA model with GHS/QoL score as response variable, and with treatment by study visit interactions and stratification factors (investigator's choice of chemotherapy \[cisplatin or carboplatin\] and PD-L1 status \[CPS\<10 vs. CPS≥10\]) at baseline as covariates.||3.18|-5.06|
70943046|NCT02853305|141386409|OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.93|1.49||No formal hypothesis testing was performed.||||TTD in GHS/QoL combined score was compared between all participants of the pembro arm and the chemo arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||1.49|0.93|
70943047|NCT02381652|141386413|OTHER|Statistical test to see if there is a difference||||||0.3108|||||||Fisher Exact|||||||0.3108
71118420|NCT03622112|141741798|SUPERIORITY||Mean Difference (Final Values)|6.129||||0.163|TWO_SIDED|95.0|-2.479|14.737|||Mixed Models Analysis|||Treatment period average||14.737|-2.479|0.163
71118421|NCT03622112|141741799|SUPERIORITY||Mean Difference (Final Values)|-0.243||||0.012|TWO_SIDED|95.0|-0.431|-0.054|||Mixed Models Analysis|||Treatment period average||-0.054|-0.431|0.012
71118422|NCT03622112|141741799|SUPERIORITY||Mean Difference (Final Values)|-0.155||||0.108|TWO_SIDED|95.0|-0.344|0.034|||Mixed Models Analysis|||Treatment period average||0.034|-0.344|0.108
71118423|NCT03622112|141741799|SUPERIORITY||Mean Difference (Final Values)|-0.099||||0.295|TWO_SIDED|95.0|-0.286|0.087|||Mixed Models Analysis|||Treatment period average||0.087|-0.286|0.295
71118424|NCT03622112|141741799|SUPERIORITY||Mean Difference (Final Values)|-0.308||||0.002|TWO_SIDED|95.0|-0.5|-0.116|||Mixed Models Analysis|||Treatment period average||-0.116|-0.500|0.002
71118425|NCT03622112|141741799|SUPERIORITY||Mean Difference (Final Values)|-0.308|||<|0.001|TWO_SIDED|95.0|-0.489|-0.126|||Mixed Models Analysis|||Treatment period average||-0.126|-0.489|<0.001
71118426|NCT03622112|141741799|SUPERIORITY||Mean Difference (Final Values)|-0.177||||0.062|TWO_SIDED|95.0|-0.362|0.009|||Mixed Models Analysis|||Treatment period average||0.009|-0.362|0.062
71118427|NCT03622112|141741800|SUPERIORITY||Mean Difference (Final Values)|-9.993|||<|0.001|TWO_SIDED|95.0|-15.795|-4.191|||Mixed Models Analysis|||Treatment period average||-4.191|-15.795|<0.001
71118428|NCT03622112|141741800|SUPERIORITY||Mean Difference (Final Values)|-7.972||||0.006|TWO_SIDED|95.0|-13.694|-2.251|||Mixed Models Analysis|||Treatment period average||-2.251|-13.694|0.006
71118429|NCT03622112|141741800|SUPERIORITY||Mean Difference (Final Values)|-4.361||||0.133|TWO_SIDED|95.0|-10.051|1.329|||Mixed Models Analysis|||Treatment period average||1.329|-10.051|0.133
71079975|NCT04227405|141667030|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up in depression subscale||||>.05
71079976|NCT04227405|141667030|SUPERIORITY||Slope|-0.29|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling|||Change from pre-test to follow-up in the Anxiety subscale for the control group|A positive value indicates an increase while a negative value indicates a decrease|||<.05
71079977|NCT04227405|141667030|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.15|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in the Anxiety subscale for the intervention group||||<.05
70854574|NCT01738477|141197594|NON_INFERIORITY|To assess the non-inferiority of the second dose of Boostrix (Boostrix 2 Group) minus first dose of Boostrix (Boostrix 1 Group) for anti-tetanus. Objective of non-inferiority was considered to be met if the LL of the 95% CI was above -10%.|Mean Difference (Final Values)|0.0||||||95.0|-3.25|9.95||||||Non-inferiority in terms of seroprotection rates to tetanus.||9.95|-3.25|
71079978|NCT04227405|141667030|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.32|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up in Anxiety subscale||||>.05
71079979|NCT04227405|141667030|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in anxiety subscale for the control group||||>.05
71079980|NCT04227405|141667030|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in anxiety subscale for the control group||||>.05
71079981|NCT04227405|141667030|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up in the Anxiety subscale||||>.05
71079982|NCT04227405|141667030|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.09|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in parenting stress subscale for the control group||||>.05
71118430|NCT03622112|141741800|SUPERIORITY||Mean Difference (Final Values)|-7.797||||0.008|TWO_SIDED|95.0|-13.555|-2.04|||Mixed Models Analysis|||Treatment period average||-2.040|-13.555|0.008
71079983|NCT04227405|141667030|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in parenting stress subscale for the intervention group||||>.05
71079984|NCT04227405|141667030|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.13|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling|||Difference between the control and the intervention group in the change from pre-test to follow-up in parenting stress subscale|Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|||>.05
71079985|NCT04227405|141667030|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.03|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in banking subscale for the control group||||<.05
71079986|NCT04227405|141667030|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in parenting stress subscale for the control group||||>.05
71079987|NCT04227405|141667030|SUPERIORITY||Slope|0.05|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up in Parenting Stress subscale||||>.05
71079988|NCT04227405|141667030|SUPERIORITY||Slope|0.26|STANDARD_ERROR_OF_MEAN|0.13|<|0.1|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Time with Partner subscale for the control group||||<.10
71079989|NCT04227405|141667030|SUPERIORITY||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.16|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Time with Parter subscale for the intervention group||||>.05
71079990|NCT04227405|141667030|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.2|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up inn Time with Partner subscale||||>.05
71118431|NCT03622112|141741800|SUPERIORITY||Mean Difference (Final Values)|-8.729||||0.002|TWO_SIDED|95.0|-14.195|-3.264|||Mixed Models Analysis|||Treatment period average||-3.264|-14.195|0.002
71118432|NCT03622112|141741800|SUPERIORITY||Mean Difference (Final Values)|-11.622|||<|0.001|TWO_SIDED|95.0|-17.211|-6.034|||Mixed Models Analysis|||Treatment period average||-6.034|-17.211|<0.001
71118433|NCT03622112|141741801|SUPERIORITY||Mean Difference (Final Values)|-0.212|||<|0.001|TWO_SIDED|95.0|-0.329|-0.094|||Mixed Models Analysis|||Treatment period average||-0.094|-0.329|<0.001
71118434|NCT03622112|141741801|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.066|TWO_SIDED|95.0|-0.228|0.007|||Mixed Models Analysis|||Treatment period average||0.007|-0.228|0.066
71118435|NCT03622112|141741801|SUPERIORITY||Mean Difference (Final Values)|-0.139||||0.02|TWO_SIDED|95.0|-0.255|-0.022|||Mixed Models Analysis|||Treatment period average||-0.022|-0.255|0.020
70954224|NCT00688870|141411075|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.78|||||TWO_SIDED|95.0|0.63|0.97|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 18C||0.97|0.63|
71118436|NCT03622112|141741801|SUPERIORITY||Mean Difference (Final Values)|-0.23|||<|0.001|TWO_SIDED|95.0|-0.35|-0.11|||Mixed Models Analysis|||Treatment period average||-0.110|-0.350|<0.001
71118437|NCT03622112|141741801|SUPERIORITY||Mean Difference (Final Values)|-0.185||||0.001|TWO_SIDED|95.0|-0.298|-0.071|||Mixed Models Analysis|||Treatment period average||-0.071|-0.298|0.001
71118438|NCT03622112|141741801|SUPERIORITY||Mean Difference (Final Values)|-0.206|||<|0.001|TWO_SIDED|95.0|-0.321|-0.09|||Mixed Models Analysis|||Treatment period average||-0.090|-0.321|<0.001
71118439|NCT03622112|141741802|SUPERIORITY||Mean Difference (Final Values)|9.611||||0.026|TWO_SIDED|95.0|1.18|18.042|||Mixed Models Analysis|||Treatment period average||18.042|1.180|0.026
71118440|NCT03622112|141741802|SUPERIORITY||Mean Difference (Final Values)|5.503||||0.2|TWO_SIDED|95.0|-2.927|13.933|||Mixed Models Analysis|||Treatment period average||13.933|-2.927|0.200
71118441|NCT03622112|141741802|SUPERIORITY||Mean Difference (Final Values)|6.787||||0.11|TWO_SIDED|95.0|-1.546|15.119|||Mixed Models Analysis|||Treatment period average||15.119|-1.546|0.110
71118442|NCT03622112|141741802|SUPERIORITY||Mean Difference (Final Values)|10.066||||0.022|TWO_SIDED|95.0|1.461|18.672|||Mixed Models Analysis|||Treatment period average||18.672|1.461|0.022
71118443|NCT03622112|141741802|SUPERIORITY||Mean Difference (Final Values)|8.62||||0.038|TWO_SIDED|95.0|0.489|16.75|||Mixed Models Analysis|||Treatment period average||16.750|0.489|0.038
71118444|NCT03622112|141741802|SUPERIORITY||Mean Difference (Final Values)|7.178||||0.09|TWO_SIDED|95.0|-1.112|15.467|||Mixed Models Analysis|||Treatment period average||15.467|-1.112|0.090
71118445|NCT03622112|141741803|SUPERIORITY||Mean Difference (Final Values)|7.936||||0.123|TWO_SIDED|95.0|-2.16|18.031|||Mixed Models Analysis|||Treatment period average||18.031|-2.160|0.123
71118446|NCT03622112|141741803|SUPERIORITY||Mean Difference (Final Values)|0.977||||0.849|TWO_SIDED|95.0|-9.112|11.065|||Mixed Models Analysis|||Treatment period average||11.065|-9.112|0.849
71118447|NCT03622112|141741803|SUPERIORITY||Mean Difference (Final Values)|-1.242||||0.807|TWO_SIDED|95.0|-11.233|8.748|||Mixed Models Analysis|||Treatment period average||8.748|-11.233|0.807
71118448|NCT03622112|141741803|SUPERIORITY||Mean Difference (Final Values)|11.789||||0.025|TWO_SIDED|95.0|1.488|22.09|||Mixed Models Analysis|||Treatment period average||22.090|1.488|0.025
71118449|NCT03622112|141741803|SUPERIORITY||Mean Difference (Final Values)|7.574||||0.127|TWO_SIDED|95.0|-2.16|17.307|||Mixed Models Analysis|||Treatment period average||17.307|-2.160|0.127
70954225|NCT00688870|141411075|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.75|||||TWO_SIDED|95.0|0.6|0.94|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 19F||0.94|0.60|
71118450|NCT03622112|141741803|SUPERIORITY||Mean Difference (Final Values)|5.058||||0.318|TWO_SIDED|95.0|-4.874|14.99|||Mixed Models Analysis|||Treatment period average||14.990|-4.874|0.318
71118451|NCT03622112|141741804|SUPERIORITY||Mean Difference (Final Values)|10.45||||0.015|TWO_SIDED|95.0|2.046|18.855|||Mixed Models Analysis|||Treatment period average||18.855|2.046|0.015
71118452|NCT03622112|141741804|SUPERIORITY||Mean Difference (Final Values)|7.192||||0.093|TWO_SIDED|95.0|-1.208|15.592|||Mixed Models Analysis|||Treatment period average||15.592|-1.208|0.093
71118453|NCT03622112|141741804|SUPERIORITY||Mean Difference (Final Values)|8.606||||0.042|TWO_SIDED|95.0|0.298|16.913|||Mixed Models Analysis|||Treatment period average||16.913|0.298|0.042
71118454|NCT03622112|141741804|SUPERIORITY||Mean Difference (Final Values)|11.344||||0.01|TWO_SIDED|95.0|2.773|19.914|||Mixed Models Analysis|||Treatment period average||19.914|2.773|0.010
71118455|NCT03622112|141741804|SUPERIORITY||Mean Difference (Final Values)|10.122||||0.014|TWO_SIDED|95.0|2.021|18.222|||Mixed Models Analysis|||Treatment period average||18.222|2.021|0.014
71118456|NCT03622112|141741804|SUPERIORITY||Mean Difference (Final Values)|10.689||||0.011|TWO_SIDED|95.0|2.424|18.953|||Mixed Models Analysis|||Treatment period average||18.953|2.424|0.011
71118457|NCT03622112|141741815|SUPERIORITY||geometric LSMean ratio|1.01||||0.909|TWO_SIDED|95.0|0.851|1.199|||Mixed Models Analysis|||||1.199|0.851|0.909
71118458|NCT03622112|141741815|SUPERIORITY||geometric LSMean ratio|1.118||||0.218|TWO_SIDED|95.0|0.935|1.336|||Mixed Models Analysis|||||1.336|0.935|0.218
71118459|NCT03622112|141741815|SUPERIORITY||geometric LSMean ratio|1.129||||0.181|TWO_SIDED|95.0|0.944|1.349|||Mixed Models Analysis|||||1.349|0.944|0.181
71118460|NCT03622112|141741815|SUPERIORITY||geometric LSMean ratio|0.984||||0.859|TWO_SIDED|95.0|0.825|1.174|||Mixed Models Analysis|||||1.174|0.825|0.859
71118461|NCT03622112|141741815|SUPERIORITY||geometric LSMean ratio|0.916||||0.285|TWO_SIDED|95.0|0.78|1.077|||Mixed Models Analysis|||||1.077|0.780|0.285
71118462|NCT03622112|141741815|SUPERIORITY||geometric LSMean ratio|0.991||||0.923|TWO_SIDED|95.0|0.831|1.182|||Mixed Models Analysis|||||1.182|0.831|0.923
71118463|NCT03359785|141741871|SUPERIORITY||LS Mean Difference|0.278|STANDARD_ERROR_OF_MEAN|0.376||0.2401|ONE_SIDED|90.0|-0.246||||ANOVA||||||-0.246|0.2401
71118464|NCT03359785|141741871|SUPERIORITY||LS Mean Difference|-0.766|STANDARD_ERROR_OF_MEAN|0.547||0.9053|ONE_SIDED|90.0|-1.513||||ANOVA||||||-1.513|0.9053
71118465|NCT03650803|141741883|OTHER|Significance (alpha) set to 0.05||||||0.046|||||||t-test, 1 sided|||MRF T1 Changes||||0.046
71118466|NCT03650803|141741883|OTHER|Significance (alpha) set to 0.05||||||0.064|||||||t-test, 2 sided|||MRF T2 Changes||||0.064
71118467|NCT03650803|141741884|OTHER|Significance (alpha) set to 0.05||||||0.82|||||||t-test, 2 sided|||MRF T1 relaxation time||||0.820
71118468|NCT03650803|141741884|OTHER|Significance (alpha) set to 0.05||||||0.605|||||||t-test, 2 sided|||MRF T2 relaxation time||||0.605
71118469|NCT01818258|141741900|SUPERIORITY|||||||0.4|||||||Fisher Exact|||Comparison for number who experienced at least one grade 3 or higher adverse event. Null hypothesis of no difference between cohorts.||||0.40
71118470|NCT01818258|141741901|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||Comparison for number who experienced at least one grade 3 or higher adverse event related to study treatment. Null hypothesis of no difference between cohorts.||||>0.999
71118471|NCT01818258|141741902|SUPERIORITY||Geometric Mean Ratio|0.77||||0.49|TWO_SIDED|95.0|0.4|1.6|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 Comparison of LPV AUC between cohorts. Null hypothesis of no difference between cohorts.||1.6|0.4|0.49
71118472|NCT01818258|141741902|SUPERIORITY||Geometric Mean Ratio|0.64||||0.23|TWO_SIDED|95.0|0.3|1.4|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 Comparison of LPV AUC between cohorts. Null hypothesis of no difference between cohorts.||1.4|0.3|0.23
71118473|NCT01818258|141741902|SUPERIORITY||Geometric Mean Ratio|0.81||||0.63|TWO_SIDED|95.0|0.3|2.0|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 Comparison of LPV AUC between cohorts. Null hypothesis of no difference between cohorts.||2.0|0.3|0.63
71118474|NCT01818258|141741903|SUPERIORITY||Geometric Mean Ratio|1.06||||0.89|TWO_SIDED|95.0|0.5|2.3|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 Comparison of LPV Clearance between cohorts. Null hypothesis of no difference between cohorts.||2.3|0.5|0.89
71118475|NCT01818258|141741903|SUPERIORITY||Geometric Mean Ratio|1.42||||0.37|TWO_SIDED|95.0|0.7|3.1|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 Comparison of LPV clearance between cohorts. Null hypothesis of no difference between cohorts.||3.1|0.7|0.37
71118476|NCT01818258|141741903|SUPERIORITY||Geometric Mean Ratio|1.23||||0.63|TWO_SIDED|95.0|0.5|2.9|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 Comparison of LPV clearance between cohorts. Null hypothesis of no difference between cohorts.||2.9|0.5|0.63
71118477|NCT01818258|141741904|SUPERIORITY||Geometric Mean Ratio|0.76||||0.42|TWO_SIDED|95.0|0.4|1.5|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 Comparison of RTV AUC between cohorts. Null hypothesis of no difference between cohorts.||1.5|0.4|0.42
71118478|NCT01818258|141741904|SUPERIORITY||Geometric Mean Ratio|0.58||||0.11|TWO_SIDED|95.0|0.3|1.1|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 comparison of RTV AUC between cohorts. Null hypothesis of no difference between cohorts.||1.1|0.3|0.11
71118479|NCT01818258|141741904|SUPERIORITY||Geometric Mean Ratio|0.77||||0.44|TWO_SIDED|95.0|0.4|1.5|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 comparison of RTV AUC between cohorts. Null hypothesis of no difference between cohorts.||1.5|0.4|0.44
71118480|NCT01818258|141741905|SUPERIORITY||Geometric Mean Ratio|1.07||||0.84|TWO_SIDED|95.0|0.5|2.2|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 comparison of RTV clearance between cohorts. Null hypothesis of no difference between cohorts.||2.2|0.5|0.84
71118481|NCT01818258|141741905|SUPERIORITY||Geometric Mean Ratio|1.54||||0.21|TWO_SIDED|95.0|0.8|3.1|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 comparison of RTV clearance between cohorts. Null hypothesis of no difference between cohorts.||3.1|0.8|0.21
71118482|NCT01818258|141741905|SUPERIORITY||Geometric Mean Ratio|1.29||||0.44|TWO_SIDED|95.0|0.7|2.5|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 comparison of RTV clearance between cohorts. Null hypothesis of no difference between cohorts.||2.5|0.7|0.44
71118483|NCT01818258|141741906|SUPERIORITY||Geometric Mean Ratio|0.77||||0.27|TWO_SIDED|95.0|0.5|1.2|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 comparison of 3TC AUC between cohorts. Null hypothesis of no difference between cohorts.||1.2|0.5|0.27
71118484|NCT01818258|141741906|SUPERIORITY||Geometric Mean Ratio|0.6||||0.047|TWO_SIDED|95.0|0.4|1.0|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 comparison of 3TC AUC between cohorts. Null hypothesis of no difference between cohorts.||1.0|0.4|0.047
71118485|NCT01818258|141741906|SUPERIORITY||Geometric Mean Ratio|1.09||||0.76|TWO_SIDED|95.0|0.6|1.9|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 comparison of 3TC AUC between cohorts. Null hypothesis of no difference between cohorts.||1.9|0.6|0.76
71118486|NCT01818258|141741907|SUPERIORITY||Geometric Mean Ratio|0.0||||0.89|TWO_SIDED|95.0|-0.4|0.5|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 comparison of 3TC clearance between cohorts. Null hypothesis of no difference between cohorts.||0.5|-0.4|0.89
71118487|NCT01818258|141741907|SUPERIORITY||Geometric Mean Ratio|1.4||||0.18|TWO_SIDED|95.0|0.8|2.3|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 comparison of 3TC clearance between cohorts. Null hypothesis of no difference between cohorts.||2.3|0.8|0.18
71118488|NCT01818258|141741907|SUPERIORITY||Geometric Mean Ratio|0.85||||0.53|TWO_SIDED|95.0|0.5|1.4|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 comparison of 3TC clearance between cohorts. Null hypothesis of no difference between cohorts.||1.4|0.5|0.53
71118489|NCT01818258|141741908|SUPERIORITY||Geometric Mean Ratio|1.27||||0.39|TWO_SIDED|95.0|0.7|2.2|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 comparison of ZDV AUC between cohorts. Null hypothesis of no difference between cohorts.||2.2|0.7|0.39
71118490|NCT01818258|141741908|SUPERIORITY||Geometric Mean Ratio|1.37||||0.43|TWO_SIDED|95.0|0.6|3.0|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 comparison of ZDV AUC between cohorts. Null hypothesis of no difference between cohorts.||3.0|0.6|0.43
71118491|NCT01818258|141741908|SUPERIORITY||Geometric Mean Ratio|1.52||||0.003|TWO_SIDED|95.0|1.2|2.0|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 comparison of ZDV AUC between cohorts. Null hypothesis of no difference between cohorts.||2.0|1.2|0.003
71118492|NCT01818258|141741909|SUPERIORITY||Geometric Mean Ratio|0.6||||0.09|TWO_SIDED|95.0|0.3|1.1|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 comparison of ZDV clearance between cohorts. Null hypothesis of no difference between cohorts.||1.1|0.3|0.090
71118493|NCT01818258|141741909|SUPERIORITY||Geometric Mean Ratio|0.6||||0.23|TWO_SIDED|95.0|0.3|1.4|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 comparison of ZDV clearance between cohorts. Null hypothesis of no difference between cohorts.||1.4|0.3|0.23
71118494|NCT01818258|141741909|SUPERIORITY||Geometric Mean Ratio|0.64||||0.0003|TWO_SIDED|95.0|0.5|0.8|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 comparison of ZDV clearance between cohorts. Null hypothesis of no difference between cohorts.||0.8|0.5|0.0003
71118495|NCT01818258|141741910|SUPERIORITY||Odds Ratio (OR)|0.54||||0.17|TWO_SIDED|95.0|0.22|1.29|||Mixed Models Analysis||Odds Ratio (SAM/non-SAM) for Lopinavir Ctrough \>= 1 ug/mL through 48 weeks|Odds ratio (SAM/non-SAM) of Ctrough \>=1 ug/mL from entry through 48 weeks from repeated measures mixed model, with the null hypothesis that the odds ratio is equal to zero (no difference between cohorts in odds of Ctrough \>=1 ug/mL).||1.29|0.22|0.17
71118496|NCT01818258|141741911|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.003|TWO_SIDED|95.0|-3.9|-0.9|||t-test, 2 sided||Severe Malnutrition Cohort - Normal Nutrition/Mild Malnutrition for Week 1 Free Fraction (%) of LPV|Week 1 comparison of LPV free faction. Null hypothesis of no difference between cohorts.||-0.9|-3.9|0.003
71118497|NCT01818258|141741911|SUPERIORITY||Mean Difference (Final Values)|-3.8||||0.011|TWO_SIDED|95.0|-6.6|-1.1|||t-test, 2 sided||Severe Malnutrition - Normal Nutrition/Mild Malnutrition for Week 12 Free Fraction (%) of LPV|Week 12 comparison of LPV free faction. Null hypothesis of no difference between cohorts.||-1.1|-6.6|0.011
71118498|NCT01818258|141741911|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.46|TWO_SIDED|95.0|-2.4|4.4|||t-test, 2 sided||Severe Malnutrition - Normal Nutrition/Mild Malnutrition for Week 24 Free Fraction (%) of LPV|Week 24 comparison of LPV free faction. Null hypothesis of no difference between cohorts.||4.4|-2.4|0.46
71118499|NCT01818258|141741912|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.15|TWO_SIDED|95.0|-0.3|1.7|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in log10 plasma HIV viral load from baseline to week 12. Null hypothesis of no difference between cohorts.||1.7|-0.3|0.15
71118500|NCT01818258|141741912|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.2|TWO_SIDED|95.0|-0.4|1.8|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in log10 plasma HIV viral load from baseline to week 24. Null hypothesis of no difference between cohorts.||1.8|-0.4|0.20
71118501|NCT01818258|141741912|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.13|TWO_SIDED|95.0|-0.2|1.8|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in log10 plasma HIV viral load from baseline to week 36. Null hypothesis of no difference between cohorts.||1.8|-0.2|0.13
71118502|NCT01818258|141741912|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.089|TWO_SIDED|95.0|-0.1|1.8|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in log10 plasma HIV viral load from baseline to week 48. Null hypothesis of no difference between cohorts.||1.8|-0.1|0.089
71118503|NCT01818258|141741913|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||Baseline Comparison, with null hypothesis of no difference between cohorts.||||>0.999
71118504|NCT01818258|141741913|SUPERIORITY|||||||0.15|||||||Fisher Exact|||Week 12 Comparison, with null hypothesis of no difference between cohorts.||||0.15
71118505|NCT01818258|141741913|SUPERIORITY|||||||0.065|||||||Fisher Exact|||Week 24 Comparison, with null hypothesis of no difference between cohorts.||||0.065
71118506|NCT01818258|141741913|SUPERIORITY|||||||0.065|||||||Fisher Exact|||Week 48 Comparison, with null hypothesis of no difference between cohorts.||||0.065
71118507|NCT01818258|141741914|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.89|TWO_SIDED|95.0|-3.9|4.4|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in CD4 percent from baseline to week 12. Null hypothesis of no difference between cohorts.||4.4|-3.9|0.89
71118508|NCT01818258|141741914|SUPERIORITY||Mean Difference (Final Values)|2.5||||0.31|TWO_SIDED|95.0|-2.5|7.6|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in CD4 percent from baseline to week 24. Null hypothesis of no difference between cohorts.||7.6|-2.5|0.31
71118509|NCT01818258|141741914|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.18|TWO_SIDED|95.0|-1.5|7.8|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in CD4 percent from baseline to week 36. Null hypothesis of no difference between cohorts.||7.8|-1.5|0.18
71118510|NCT01818258|141741914|SUPERIORITY||Mean Difference (Final Values)|6.1||||0.018|TWO_SIDED|95.0|1.1|11.0|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference between cohorts of change in CD4 percent from baseline to week 48. Null hypothesis of no difference between cohorts.||11.0|1.1|0.018
71118511|NCT01818258|141741915|SUPERIORITY||Mean|2.34|||<|0.0001|TWO_SIDED|95.0|1.77|2.91|||t-test, 2 sided|||Null hypothesis: change in WHO weight-for-height Z-score from entry to week 24 equal to 0||2.91|1.77|<0.0001
71118512|NCT01818258|141741915|SUPERIORITY||Mean|2.73|||<|0.0001|TWO_SIDED|95.0|2.09|3.37|||t-test, 2 sided|||Null hypothesis: change in WHO weight-for-height Z-score from entry to week 48 equal to 0||3.37|2.09|<0.0001
71118513|NCT01818258|141741916|SUPERIORITY||Mean|2.63|||<|0.0001|TWO_SIDED|95.0|1.96|3.28|||t-test, 2 sided|||Null hypothesis: change in MUAC from entry to week 24 equal to 0||3.28|1.96|<0.0001
71118514|NCT01818258|141741916|SUPERIORITY||Mean|3.53|||<|0.0001|TWO_SIDED|95.0|2.83|4.24|||t-test, 2 sided|||Null hypothesis: change in MUAC from entry to week 48 equal to 0||4.24|2.83|<0.0001
71118515|NCT03655301|141741919|OTHER||Least squares mean|0.9405|||||TWO_SIDED|90.0|0.8093|1.0931||||||Day 8 (with copanlisib) to Day 1 (without copanlisib) ratio of Cmax||1.0931|0.8093|
71118516|NCT03655301|141741920|OTHER||Least squares mean|1.1205|||||TWO_SIDED|90.0|1.0|1.2555||||||Day 8 (with copanlisib) to Day 1 (without copanlisib) ratio of AUC(0-24)||1.2555|1.0000|
71118517|NCT03655301|141741921|OTHER||Least squares mean|1.1147|||||TWO_SIDED|90.0|0.9772|1.2714||||||Day 8 (with copanlisib) to Day 1 (without copanlisib) ratio of AUC||1.2714|0.9772|
71118518|NCT01349322|141741957|NON_INFERIORITY|Non-inferiority is defined as a hazard ratio upper limit of 2.12.|Hazard Ratio (HR)|1.32||||0.039|TWO_SIDED|90.0|0.84|2.05|||Regression, Cox||Cause-specific hazard ratio; reference level = Arm 1.|"Assuming Arm 1 5-year IBR of 1.59%, for hypothesized upper bound hazard ratio (HR) of 2.12 (Arm 2 5-year IBR of 3.33%), 46 IBR events provide \>80% power to conclude non-inferiority with one-sided significance level = 0.05. Null hypothesis: HR ≥ 2.12 (inferior). Alternative hypothesis: HR \< 2.12 (non-inferior). See Limitations and Caveats section."||2.05|0.84|0.039
71118519|NCT01349322|141741958|SUPERIORITY|||||||0.96||||||Two-sided significance level = 0.05|Log Rank|||||||0.96
71118520|NCT01349322|141741959|SUPERIORITY|||||||0.14||||||Two-sided significance level = 0.05.|Log Rank|||||||0.14
71118521|NCT01349322|141741960|SUPERIORITY|||||||0.34||||||Two-sided significance level = 0.05|Log Rank|||||||0.34
71118522|NCT01349322|141741962|NON_INFERIORITY|Null hypothesis (H0) of inferiority: the mean change in cosmetic subscale score in Arm 2 will be at least 0.4 standard deviations worse than in Arm 1. If H0 is rejected, then non-inferiority can be concluded.|Mean Difference (Final Values)|0.026|STANDARD_DEVIATION|0.62|<|0.0001|TWO_SIDED|95.0|-0.08|0.13||One-side significance level = 0.025|t-test, 1 sided|||||0.13|-0.08|<0.0001
71118523|NCT02063867|141741967|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||0.17
71118524|NCT02063867|141741968|SUPERIORITY|||||||0.16|||||||Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||0.16
71118525|NCT02063867|141741969|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||0.43
71118526|NCT02063867|141741976|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||<0.001
71118527|NCT02063867|141741977|SUPERIORITY|||||||0.0126||||||Remains significant after adjusting for multiple comparisons|Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||0.0126
71118528|NCT02063867|141741978|SUPERIORITY|||||||0.002||||||Remained significant after adjusting for multiple comparisons|Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||0.002
71118529|NCT02063867|141741979|SUPERIORITY|||||||0.0032||||||Remained significant after adjusting for multiple comparisons|Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||0.0032
70943048|NCT01340300|141386414|SUPERIORITY||||||<|0.0001||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of insulin in treatment arm is greater than the control arm.||||<0.0001
70943049|NCT01340300|141386414|SUPERIORITY|||||||0.003||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of insulin in treatment arm is greater than the control arm.||||0.003
70943050|NCT01340300|141386414|SUPERIORITY|||||||0.01||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of insulin in treatment arm is greater than the control arm.||||0.01
70943051|NCT01340300|141386414|SUPERIORITY|||||||0.03||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Insulin in combined arm is greater than the exercise-only or metformin-only arm.||||0.03
70943052|NCT01340300|141386415|SUPERIORITY|||||||0.0002||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of leptin in treatment arm is greater than the control arm.||||0.0002
70943053|NCT01340300|141386415|SUPERIORITY|||||||0.002||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of IGFBP\_1 in treatment arm is greater than the control arm.||||0.002
70943054|NCT01340300|141386415|SUPERIORITY|||||||0.02||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of IGFBP\_1 in treatment arm is greater than the control arm.||||0.02
70943055|NCT01340300|141386415|SUPERIORITY|||||||0.0002||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Leptin in combined arm is greater than the exercise-only or metformin-only arm.||||0.0002
71079991|NCT04227405|141667030|SUPERIORITY||Slope|-0.14|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in Time with Partner subscale for the control group||||<.001
71079992|NCT04227405|141667030|SUPERIORITY||Slope|0.05|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in Time with Partner subscale for the intervention group||||>.05
71079993|NCT04227405|141667030|SUPERIORITY||Slope|0.2|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling|||Difference between the control and the intervention group in the change from post-test to follow-up in Time with Partner subscale|Changes from post-test to follow-up in the intervention group were significantly different from the change from post-test to follow-up in the control group|||<.001
71079994|NCT04227405|141667030|SUPERIORITY||Slope|0.13|STANDARD_ERROR_OF_MEAN|0.05|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Conflict Management Satisfaction subscale for the control group||||<.05
71079995|NCT04227405|141667030|SUPERIORITY||Slope|0.32|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Conflict Management Satisfaction subscale for the control group||||<.001
71079996|NCT04227405|141667030|SUPERIORITY||Slope|0.19|STANDARD_ERROR_OF_MEAN|0.08|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up in Conflict Management Satisfaction subscale||||<.05
71079997|NCT04227405|141667030|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in Conflict Management Satisfaction subscale for the control group||||>.05
70943056|NCT01340300|141386415|SUPERIORITY|||||||0.02||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Leptin in combined arm is greater than the exercise-only or metformin-only arm.||||0.02
70854575|NCT02509117|141197705|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-58.659|STANDARD_ERROR_OF_MEAN|0.0642|<|0.0001|TWO_SIDED|80.0|-61.95|-55.08|||Mixed Model Repeated Measures|||ABeta 1-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-55.08|-61.95|<0.0001
70854576|NCT02509117|141197705|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-68.026|STANDARD_ERROR_OF_MEAN|0.0665|<|0.0001|TWO_SIDED|80.0|-70.66|-65.16|||Mixed Model Repeated Measures|||ABeta 1-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-65.16|-70.66|<0.0001
70854577|NCT02509117|141197705|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-86.152|STANDARD_ERROR_OF_MEAN|0.0643|<|0.0001|TWO_SIDED|80.0|-87.26|-84.95|||Mixed Model Repeated Measures|||ABeta 1-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-84.95|-87.26|<0.0001
70854578|NCT02509117|141197705|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.558|STANDARD_ERROR_OF_MEAN|0.0558|<|0.0001|TWO_SIDED|80.0|-44.7|-36.1|||Mixed Model Repeated Measures|||ABeta x-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-36.10|-44.70|<0.0001
70854579|NCT02509117|141197705|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-51.368|STANDARD_ERROR_OF_MEAN|0.0561|<|0.0001|TWO_SIDED|80.0|-54.78|-47.7|||Mixed Model Repeated Measures|||ABeta x-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-47.70|-54.78|<0.0001
70854580|NCT02509117|141197705|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-59.583|STANDARD_ERROR_OF_MEAN|0.0558|<|0.0001|TWO_SIDED|80.0|-62.4|-56.56|||Mixed Model Repeated Measures|||ABeta x-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-56.56|-62.40|<0.0001
70854581|NCT02509117|141197705|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-37.373|STANDARD_ERROR_OF_MEAN|0.1007|<|0.0001|TWO_SIDED|80.0|-45.06|-28.62|||Mixed Model Repeated Measures|||ABeta Total: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-28.62|-45.06|<0.0001
70854582|NCT02509117|141197705|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-45.018|STANDARD_ERROR_OF_MEAN|0.1001|<|0.0001|TWO_SIDED|80.0|-51.72|-37.38|||Mixed Model Repeated Measures|||ABeta Total: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-37.38|-51.72|<0.0001
70854583|NCT02509117|141197705|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.797|STANDARD_ERROR_OF_MEAN|0.1014|<|0.0001|TWO_SIDED|80.0|-66.51|-56.42|||Mixed Model Repeated Measures|||ABeta Total: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-56.42|-66.51|<0.0001
70854584|NCT00029146|141197736|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|1.7||||0.78||95.0|-10.4|13.8|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Positive indicates lower rate in surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference. The 2-sided z-statistic was compared to a standard unit normal distribution.The study was terminated early for futility after 195 of the planned 372 participants were enrolled.||13.8|-10.4|0.78
70943057|NCT01340300|141386416|SUPERIORITY|||||||0.0004||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Glucose in treatment arm is greater than the control arm.||||0.0004
70854585|NCT00029146|141197737|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|3.5||||0.59|TWO_SIDED|95.0|-9.2|16.1|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Positive indicates lower rate in surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors.||16.1|-9.2|0.59
70854586|NCT00029146|141197738|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|-3.2||||0.27|TWO_SIDED|95.0|-9.0|2.6|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Negative indicates lower rate in non-surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.||2.6|-9.0|0.27
70854587|NCT00029146|141197739|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|1.3||||0.5|TWO_SIDED|95.0|-2.5|5.2|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Positive indicates lower rate in surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.||5.2|-2.5|0.50
70854588|NCT00029146|141197740|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|4.0||||0.13|TWO_SIDED|95.0|-1.2|9.7|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Positive indicates lower rate in surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.||9.7|-1.2|0.13
70854589|NCT00029146|141197741|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|6.5||||0.33|TWO_SIDED|95.0|-6.5|19.6|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Positive indicates lower rate in surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.||19.6|-6.5|.33
70854590|NCT00029146|141197742|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|-6.6||||0.41|TWO_SIDED|95.0|-20.6|7.3|||Fisher Exact||Negative indicates lower rate in non-surgical group. In this case, lower rate is worse since Rankin 0-1 indicates a good outcome.|||7.3|-20.6|0.41
70854591|NCT00029146|141197743|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|4.4||||0.7|TWO_SIDED|95.0|-8.2|16.9|||Fisher Exact||Positive indicates lower rate in surgical group In this case, lower rate is worse since Rankin 0-2 indicates a good outcome.|||16.9|-8.2|0.70
70854592|NCT00029146|141197744|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Fisher's Exact Test|||||||0.85
70943058|NCT01340300|141386416|SUPERIORITY|||||||0.007||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Glucose in treatment arm is greater than the control arm.||||0.007
70943059|NCT01340300|141386417|SUPERIORITY||||||<|0.0001||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Weight in treatment arm is greater than the control arm.||||<0.0001
70943060|NCT01340300|141386417|SUPERIORITY||||||<|0.0001||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Weight in treatment arm is greater than the control arm.||||<0.0001
70943061|NCT01340300|141386417|SUPERIORITY|||||||0.01||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Weight in treatment arm is greater than the control arm.||||0.01
70943062|NCT01340300|141386418|SUPERIORITY||||||<|0.0001||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of BMI in treatment arm is greater than the control arm.||||<0.0001
70943063|NCT01340300|141386418|SUPERIORITY||||||<|0.0001||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of BMI in treatment arm is greater than the control arm.||||<0.0001
70943064|NCT01340300|141386418|SUPERIORITY|||||||0.02||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of BMI in treatment arm is greater than the control arm.||||0.02
70943065|NCT01340300|141386419|SUPERIORITY|||||||0.01||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Waist to Hip Ratio in treatment arm is greater than the control arm.||||0.01
70943066|NCT03544229|141386420|SUPERIORITY||Least Square Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.25|=|0.618|TWO_SIDED|90.0|-0.34|0.49||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD composite score was \<0.|MMRM||MMRM included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.49|-0.34|=0.618
70943067|NCT03544229|141386420|SUPERIORITY||Least Square Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.17|=|0.533|TWO_SIDED|90.0|-0.27|0.29||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD composite score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.29|-0.27|=0.533
70943068|NCT03544229|141386420|SUPERIORITY||Least Square Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.167|=|0.447|TWO_SIDED|90.0|-0.3|0.25||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD composite score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.25|-0.30|=0.447
70954226|NCT00688870|141411075|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.59|||||TWO_SIDED|95.0|0.46|0.77|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 23F||0.77|0.46|
71079998|NCT04227405|141667030|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in conflict management satisfaction subscale for the intervention group||||>.05
71079999|NCT04227405|141667030|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling|||Difference between the control and the intervention group in the change from post-test to follow-up in Conflict Management Satisfaction subscale|Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|||>.05
70943069|NCT03544229|141386421|SUPERIORITY||Odds Ratio (OR)|0.87|||=|0.607|TWO_SIDED|90.0|0.39|1.96|||Logistic Regression||Comparisons of TAK-906 to Placebo was based on logistic regression with at least 50% reduction of participants from baseline in weekly composite score with baseline composite score, disease population at randomization, and treatment as covariates.|||1.96|0.39|=0.607
70943070|NCT03544229|141386421|SUPERIORITY||Odds Ratio (OR)|1.21|||=|0.283|TWO_SIDED|90.0|0.7|2.1|||Logistic Regression||Comparisons of TAK-906 to Placebo was based on logistic regression with at least 50% reduction of participants from baseline in weekly composite score with baseline composite score, disease population at randomization, and treatment as covariates.|||2.10|0.70|=0.283
70943071|NCT03544229|141386421|SUPERIORITY||Odds Ratio (OR)|0.98|||=|0.527|TWO_SIDED|90.0|0.56|1.69|||Logistic Regression||Comparisons of TAK-906 to Placebo was based on logistic regression with at least 50% reduction of participants from baseline in weekly composite score with baseline composite score, disease population at randomization, and treatment as covariates.|||1.69|0.56|=0.527
70943072|NCT03544229|141386422|SUPERIORITY||Least-Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.279|=|0.584|TWO_SIDED|90.0|-0.4|0.52||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD nausea symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.52|-0.40|=0.584
70943073|NCT03544229|141386422|SUPERIORITY||Least-Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.189|=|0.625|TWO_SIDED|90.0|-0.25|0.37||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD nausea symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.37|-0.25|=0.625
70943074|NCT03544229|141386422|SUPERIORITY||Least-Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.187|=|0.54|TWO_SIDED|90.0|-0.29|0.33||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD nausea symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.33|-0.29|=0.540
70943075|NCT03544229|141386423|SUPERIORITY||Least-Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.283|=|0.51|TWO_SIDED|90.0|-0.46|0.47||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD early satiety symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.47|-0.46|=0.510
70943076|NCT03544229|141386423|SUPERIORITY||Least-Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.192|=|0.674|TWO_SIDED|90.0|-0.23|0.4||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD early satiety symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.40|-0.23|=0.674
70943077|NCT03544229|141386423|SUPERIORITY||Least-Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.189|=|0.367|TWO_SIDED|90.0|-0.38|0.25||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD early satiety symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.25|-0.38|=0.367
70943078|NCT03544229|141386424|SUPERIORITY||Least-Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.289|=|0.587|TWO_SIDED|90.0|-0.41|0.54||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD postprandial fullness symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.54|-0.41|=0.587
71118530|NCT04376684|141741983|OTHER||Odds Ratio (OR)|1.32||||0.0456|TWO_SIDED|95.0|0.96|1.82||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.82|0.96|0.0456
70943079|NCT03544229|141386424|SUPERIORITY||Least-Squares Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.196|=|0.6|TWO_SIDED|90.0|-0.27|0.37||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD postprandial fullness symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.37|-0.27|=0.600
70954227|NCT00688870|141411075|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|202.58|||||TWO_SIDED|95.0|157.04|261.32|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 1||261.32|157.04|
71118531|NCT04376684|141741984|OTHER||Odds Ratio (OR)|1.04||||0.8574|TWO_SIDED|95.0|0.67|1.61||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.61|0.67|0.8574
70943080|NCT03544229|141386424|SUPERIORITY||Least-Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.193|=|0.446|TWO_SIDED|90.0|-0.34|0.29||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD postprandial fullness symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.29|-0.34|=0.446
70943081|NCT03544229|141386425|SUPERIORITY||Least-Squares Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.245|=|0.562|TWO_SIDED|90.0|-0.37|0.44||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD upper abdominal pain symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.44|-0.37|=0.562
70943082|NCT03544229|141386425|SUPERIORITY||Least-Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.166|=|0.138|TWO_SIDED|90.0|-0.46|0.09||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD upper abdominal pain symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.09|-0.46|=0.138
70943083|NCT03544229|141386425|SUPERIORITY||Least-Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.164|=|0.394|TWO_SIDED|90.0|-0.32|0.23||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD upper abdominal pain symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.23|-0.32|=0.394
70954228|NCT00688870|141411075|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|24.11|||||TWO_SIDED|95.0|18.46|31.49|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 3||31.49|18.46|
71080000|NCT04227405|141667030|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.05|<|0.1|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in budgeting subscale for the control group||||<.10
70854593|NCT00029146|141197745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.13|TWO_SIDED|95.0|-0.54|0.07|||t-test, 2 sided||Negative indicates lower score in non-surgical group.A higher score indicates better quality of life|||0.07|-0.54|0.13
70871983|NCT03919799|141229333|SUPERIORITY|MMRM analysis used rank-transformed data, with CRISS score as a dependent variable and treatment, visit, and visit x treatment interaction as fixed effects. Visit was a repeated factor, and analyses were done through week 24.|Least square mean difference|-0.04||||0.9889|TWO_SIDED|95.0|-6.51|6.42||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||6.42|-6.51|0.9889
70943084|NCT03544229|141386426|SUPERIORITY||Least-Squares Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.484|=|0.709|TWO_SIDED|90.0|-0.53|1.07||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD recorded vomiting frequency was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||1.07|-0.53|=0.709
70943085|NCT03544229|141386426|SUPERIORITY||Least-Squares Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.332|=|0.76|TWO_SIDED|90.0|-0.31|0.78||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD recorded vomiting frequency was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.78|-0.31|=0.760
70943086|NCT03544229|141386426|SUPERIORITY||Least-Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.33|=|0.591|TWO_SIDED|90.0|-0.47|0.62||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD recorded vomiting frequency was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.62|-0.47|=0.591
70943087|NCT03544229|141386427|SUPERIORITY||Least-Squares Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.27|=|0.742|TWO_SIDED|90.0|-0.27|0.62||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD overall severity of gastroparesis symptoms score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.62|-0.27|=0.742
70943088|NCT03544229|141386427|SUPERIORITY||Least-Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.183|=|0.461|TWO_SIDED|90.0|-0.32|0.28||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD overall severity of gastroparesis symptoms score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.28|-0.32|=0.461
70943089|NCT03544229|141386427|SUPERIORITY||Least-Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.181|=|0.376|TWO_SIDED|90.0|-0.36|0.24||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD overall severity of gastroparesis symptoms score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.24|-0.36|=0.376
71080001|NCT04227405|141667030|SUPERIORITY||Slope|0.12|STANDARD_ERROR_OF_MEAN|0.06|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Budgeting subscale for the intervention group||||<.05
70943090|NCT03544229|141386428|SUPERIORITY||Least-Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.286|=|0.591|TWO_SIDED|90.0|-0.41|0.54||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD bloating severity scale score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.54|-0.41|=0.591
70943091|NCT03544229|141386428|SUPERIORITY||Least-Squares mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.193|=|0.291|TWO_SIDED|90.0|-0.43|0.21||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD bloating severity scale score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.21|-0.43|=0.291
71118532|NCT04376684|141741985|OTHER||Odds Ratio (OR)|0.86||||0.2057|TWO_SIDED|95.0|0.61|1.22||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.22|0.61|0.2057
71118533|NCT04376684|141741986|OTHER||Odds Ratio (OR)|0.79||||0.3061|TWO_SIDED|95.0|0.5|1.24||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.24|0.50|0.3061
71118534|NCT04376684|141741987|OTHER||Odds Ratio (OR)|0.91||||0.6665|TWO_SIDED|95.0|0.59|1.41||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.41|0.59|0.6665
71118535|NCT04376684|141741988|OTHER||Hazard Ratio (HR)|0.88||||0.1942|TWO_SIDED|95.0|0.65|1.18||p-value is from a one-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized and age group as randomized.|||1.18|0.65|0.1942
71118536|NCT04376684|141741989|OTHER||Hazard Ratio (HR)|0.9||||0.5324|TWO_SIDED|95.0|0.65|1.24||p-value is generated from a two-sided test|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized, sex as randomized and age.|||1.24|0.65|0.5324
70854594|NCT00029146|141197746|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|1.5||||0.81|TWO_SIDED|95.0|-10.7|13.7|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.||Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.||13.7|-10.7|0.81
70854595|NCT02199717|141197748|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||All statistical analyses were completed using SAS 9.4 (SAS Institute Inc., Cary, NC, USA). Descriptive statistics such as mean (± SD) and range were calculated and provided for demographic variables, accelerometry variables and questionnaire outcomes. Differences between the two groups (mild/moderate versus severe haemophilia) were examined in exploratory analyses.||||0.32
70854596|NCT02199717|141197749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|306.4|||<|0.01|TWO_SIDED|95.0|254.8|358.0|||Wilcoxon (Mann-Whitney)|||||358|254.8|<0.01
70854597|NCT03567343|141197750|EQUIVALENCE|Significance set to 0.05|Mean Difference (Net)|-2.1||||0.1543|TWO_SIDED|95.0|-5.03|0.82||The threshold for statistical significance was P\< 0.05.|Paired T-test|||||0.82|-5.03|0.1543
70854598|NCT03567343|141197750|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-2.53||||0.1827|TWO_SIDED|95.0|-6.3|1.24|||Paired T-test|||||1.24|-6.3|0.1827
70854599|NCT03567343|141197751|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.2||||0.8165|TWO_SIDED|95.0|-1.96|1.56|||Paired T-test|||||1.56|-1.96|0.8165
70854600|NCT03567343|141197751|EQUIVALENCE|P\<0.05|Mean Difference (Net)|1.58||||0.1821|TWO_SIDED|95.0|-0.77|3.94|||Paired T-test|||||3.94|-0.77|0.1821
70854601|NCT03567343|141197752|EQUIVALENCE|P\<0.05|Mean Difference (Net)|20.94||||0.0156|TWO_SIDED|95.0|4.19|37.69|||Paired T-test|||||37.69|4.19|0.0156
70854602|NCT03567343|141197752|EQUIVALENCE|P\<0.05|Mean Difference (Net)|20.08||||0.0572|TWO_SIDED|95.0|-0.64|40.8|||Paired T-test|||||40.8|-0.64|0.0572
70854603|NCT03567343|141197753|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-4.48||||0.0781|TWO_SIDED|95.0|-9.37|0.41|||Paired T-test|||||0.41|-9.37|0.0781
70854604|NCT03567343|141197753|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-3.0||||0.242|TWO_SIDED|95.0|-8.1|2.1|||Paired T-test|||||2.1|-8.1|0.242
70854605|NCT03567343|141197754|EQUIVALENCE|P\<0.05|Mean Difference (Net)|2.91||||0.0195|TWO_SIDED|95.0|0.49|5.32|||Paired T-test|||||5.32|0.49|0.0195
70854606|NCT03567343|141197754|EQUIVALENCE|P\<0.05|Mean Difference (Net)|4.66||||0.0097|TWO_SIDED|95.0|1.19|8.12|||Paired T-test|||||8.12|1.19|0.0097
70854607|NCT03567343|141197755|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.93|||<|0.0001|TWO_SIDED|95.0|0.59|1.28|||Paired T-test|||||1.28|0.59|<0.0001
70854608|NCT03567343|141197755|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.45||||0.0179|TWO_SIDED|95.0|0.08|0.81|||Paired T-test|||||0.81|0.08|0.0179
70854609|NCT03567343|141197756|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.03||||0.9875|TWO_SIDED|95.0|-3.89|3.83|||Paired T-test|||||3.83|-3.89|0.9875
71080002|NCT04227405|141667030|SUPERIORITY||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.07|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Difference between the control and the intervention group in the change from pre-test to follow-up in Budgeting subscale|Changes from pre-test to follow-up in the intervention group were significantly different from the change from pre-test to follow-up in the control group|||<.01
71080003|NCT04227405|141667030|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in budgeting subscale for the control group||||<.001
71080004|NCT04227405|141667030|SUPERIORITY||Slope|0.11|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in budgeting subscale for the intervention group||||<.001
71080005|NCT04227405|141667030|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Difference between the control and the intervention group in the change from pre-test to follow-up in Budgeting subscale|Changes from pre-test to follow-up in the intervention group were significantly different from the change from pre-test to follow-up in the control group|||<.001
71080006|NCT04227405|141667032|SUPERIORITY||Slope|-0.35|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Acceptance subscale for the control group||||<.05
71080007|NCT04227405|141667032|SUPERIORITY||Slope|0.33|STANDARD_ERROR_OF_MEAN|0.14|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Acceptance subscale for the intervention group||||<.05
71080008|NCT04227405|141667032|SUPERIORITY||Slope|0.68|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Acceptance subscale||||<.001
71080009|NCT04227405|141667032|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Active Coping subscale for the control group||||<.05
71080010|NCT04227405|141667032|SUPERIORITY||Slope|0.38|STANDARD_ERROR_OF_MEAN|0.15|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Active Coping subscale for the intervention group||||<.05
71080011|NCT04227405|141667032|SUPERIORITY||Slope|0.72|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED||||||Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Post-test in the Active Coping subscale|The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|||<.001
71080012|NCT04227405|141667032|SUPERIORITY||Slope|-0.32|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Planning subscale for the control group||||<.05
71080013|NCT04227405|141667032|SUPERIORITY||Slope|0.44|STANDARD_ERROR_OF_MEAN|0.15|<|0.01|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Planning subscale for the intervention group||||<.01
71080014|NCT04227405|141667032|SUPERIORITY||Slope|0.76|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Planning subscale||||<.001
71080015|NCT04227405|141667032|SUPERIORITY||Slope|-0.15|STANDARD_ERROR_OF_MEAN|0.12|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Instrumental Support subscale for the control group||||>.05
71080016|NCT04227405|141667032|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.15|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Instrumental Support subscale for the intervention group||||>.05
70854610|NCT03567343|141197756|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.2||||0.9463|TWO_SIDED|95.0|-6.23|5.82|||Paired T-test|||||5.82|-6.23|0.9463
71080017|NCT04227405|141667032|SUPERIORITY||Slope|0.12|STANDARD_ERROR_OF_MEAN|0.18|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Instrumental Support subscale||||>.05
71080018|NCT04227405|141667033|SUPERIORITY||Slope|-0.36|STANDARD_ERROR_OF_MEAN|0.14|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Acceptance subscale for the control group||||<.10
71080019|NCT04227405|141667033|SUPERIORITY||Slope|0.41|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Acceptance subscale for the intervention group||||<.05
71080020|NCT04227405|141667033|SUPERIORITY||Slope|0.77|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Aceptance subscale||||<.001
71080021|NCT04227405|141667033|SUPERIORITY||Slope|-0.36|STANDARD_ERROR_OF_MEAN|0.15|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Active Coping subscale for the control group||||<.10
71080022|NCT04227405|141667033|SUPERIORITY||Slope|0.4|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Active Coping subscale for the intervention group||||<.05
71080023|NCT04227405|141667033|SUPERIORITY||Slope|0.76|STANDARD_ERROR_OF_MEAN|0.22|<|0.01|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Active Coping subscale||||<.01
71080024|NCT04227405|141667033|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.15|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Planning subscale for the control group||||<.10
71080025|NCT04227405|141667033|SUPERIORITY||Slope|0.59|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Planning subscale for the intervention group||||<.05
71080026|NCT04227405|141667033|SUPERIORITY||Slope|0.94|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Planning subscale||||<.001
71080027|NCT04227405|141667033|SUPERIORITY||Slope|-0.11|STANDARD_ERROR_OF_MEAN|0.15|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Instrumental Support subscale for the control group||||>.05
71080028|NCT04227405|141667033|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.18|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Instrumental Support subscale for the Intervention group||||>.05
71080029|NCT04227405|141667033|SUPERIORITY||Slope|0.13|STANDARD_ERROR_OF_MEAN|0.23|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Instrumental Support subscale||||>.05
71118537|NCT04376684|141741990|OTHER||Odds Ratio (OR)|1.09||||0.2871|TWO_SIDED|95.0|0.8|1.49||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.49|0.80|0.2871
71118538|NCT04376684|141741991|OTHER||Odds Ratio (OR)|1.16||||0.1754|TWO_SIDED|95.0|0.85|1.58||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.58|0.85|0.1754
70854611|NCT03567343|141197757|EQUIVALENCE|P\<0.05|Mean Difference (Net)|28.5||||0.0037|TWO_SIDED|95.0|9.84|47.17|||Paired T-test|||||47.17|9.84|0.0037
70854612|NCT03567343|141197757|EQUIVALENCE|p\<0.05|Mean Difference (Net)|9.84||||0.4395|TWO_SIDED|95.0|-15.63|35.31|||Paired T-test|||||35.31|-15.63|0.4395
71080030|NCT04227405|141667033|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Acceptance subscale for the control group||||>.05
71080031|NCT04227405|141667033|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Acceptance subscale for the intervention group||||>.05
71080032|NCT04227405|141667033|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Positive Conflict Management subscale||||>.05
71118539|NCT04376684|141741992|OTHER||Odds Ratio (OR)|1.29||||0.0616|TWO_SIDED|95.0|0.93|1.79||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.79|0.93|0.0616
70943092|NCT03544229|141386428|SUPERIORITY||Least-Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.191|=|0.476|TWO_SIDED|90.0|-0.33|0.3||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD bloating severity scale score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.30|-0.33|=0.476
70943093|NCT03544229|141386429|SUPERIORITY||Least-Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.224|=|0.675|TWO_SIDED|90.0|-0.27|0.47||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD total score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.47|-0.27|=0.675
70943094|NCT03544229|141386429|SUPERIORITY||Least-Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.152|=|0.531|TWO_SIDED|90.0|-0.24|0.26||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD total score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.26|-0.24|=0.531
70943095|NCT03544229|141386429|SUPERIORITY||Least-Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.15|=|0.473|TWO_SIDED|90.0|-0.26|0.24||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD total score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.24|-0.26|=0.473
70943096|NCT03544229|141386430|SUPERIORITY||Least-Squares Mean Difference|-8.47|STANDARD_ERROR_OF_MEAN|9.71|=|0.192|TWO_SIDED|90.0|-24.5|7.57||The 1-sided p-value was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 -Placebo) in symptomatic weeks was \<0.|ANOVA|||||7.57|-24.50|=0.192
71080033|NCT04227405|141667033|SUPERIORITY|Changes from post-test to Follow-up in the Active Coping subscale for the control group|Slope|0.02|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|||||>.05
71080034|NCT04227405|141667033|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Active Coping subscale for the intervention group||||>.05
70943097|NCT03544229|141386430|SUPERIORITY||Least-Squares Mean Difference|-4.85|STANDARD_ERROR_OF_MEAN|6.736|=|0.236|TWO_SIDED|90.0|-15.98|6.27||The 1-sided p-value was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in symptomatic weeks was \<0.|ANOVA|||||6.27|-15.98|=0.236
70943098|NCT03544229|141386430|SUPERIORITY||Least-Squares Mean Difference|-3.58|STANDARD_ERROR_OF_MEAN|6.689|=|0.297|TWO_SIDED|90.0|-14.62|7.47||The 1-sided p-value was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in symptomatic weeks was \<0.|ANOVA|||||7.47|-14.62|=0.297
70943099|NCT03544229|141386431|SUPERIORITY||Least-Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.3|=|0.601|TWO_SIDED|90.0|-0.42|0.57||1-sided p-values were obtained using MMRM of PAGI-SYM total score. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in PAGI-SYM total score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.57|-0.42|=0.601
70943100|NCT03544229|141386431|SUPERIORITY||Least-Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.2|=|0.181|TWO_SIDED|90.0|-0.51|0.15||1-sided p-values were obtained using MMRM of PAGI-SYM total score. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in PAGI-SYM total score was \<0.|MMRM||MMRM model includes week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.15|-0.51|=0.181
70943101|NCT03544229|141386431|SUPERIORITY||Least-Squares Mean Diferrence|-0.24|STANDARD_ERROR_OF_MEAN|0.196|=|0.114|TWO_SIDED|90.0|-0.56|0.09||1-sided p-values were obtained using MMRM of PAGI-SYM total score. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in PAGI-SYM total score was \<0.|MMRM||MMRM model includes week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.09|-0.56|=0.114
70854613|NCT03567343|141197758|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.03||||0.912|TWO_SIDED|95.0|-0.59|0.53|||Paired T-test|||||0.53|-0.59|0.912
70854614|NCT03567343|141197758|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.11||||0.8207|TWO_SIDED|95.0|-1.04|0.83|||Paired T-test|||||0.83|-1.04|.8207
70854615|NCT03567343|141197759|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.89||||0.1929|TWO_SIDED|95.0|-2.26|0.47|||Paired T-test|||||0.47|-2.26|0.1929
70854616|NCT03567343|141197759|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.24||||0.8744|TWO_SIDED|95.0|-3.35|2.86|||Paired T-test|||||2.86|-3.35|0.8744
70854617|NCT03567343|141197760|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.95||||0.2048|TWO_SIDED|95.0|-2.45|0.54|||Paired T-test|||||0.54|-2.45|0.2048
70954229|NCT00688870|141411075|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|5.69|||||TWO_SIDED|95.0|4.37|7.41|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 5||7.41|4.37|
70854618|NCT03567343|141197760|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.96||||0.1933|TWO_SIDED|95.0|-0.5|2.42|||Paired T-test|||||2.42|-0.5|0.1933
70854619|NCT03567343|141197761|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-1.69||||0.034|TWO_SIDED|95.0|-3.25|-0.13|||Paired T-test|||change in mean number of lapses||-0.13|-3.25|0.034
70943102|NCT02460562|141386457|SUPERIORITY||||||<|0.05||||||Mean salivary fluoride concentrations (part per million) between groups were assessed at different time points using repeated measures analysis of variance. Saliva fluoride concentration from each groups were compared with baseline using a t-test.|ANOVA|||Mean saliva fluoride concentration (part per million) collected at different time points was compared in order to assess the change in capacity for fluoride release and recharge from the resin denture base and to assess differences between the control and the intervention group.||||<0.05
70943103|NCT02460562|141386458|SUPERIORITY||Odds Ratio (OR)|0.45|||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||Caries assessments were performed to examine the difference in mean number of surface caries (DMFS) ± standard deviation between the control and the intervention groups at baseline and at 1.5 years.The transition (∆Q) of developed new caries surfaces (ICDAS score 1-3) from baseline to 1.5 years of follow-up for the two groups was analyzed with respect to arrest or progress rates. Numbers of new caries surfaces were compared by independent t-test, Pearson chi-square and correlation coefficient.||||<0.05
70943104|NCT03303521|141386459|SUPERIORITY||Odds Ratio (OR)|68.77|||<|0.001|TWO_SIDED|95.0|10.85|2810.85|||Fisher Exact|||||2810.85|10.85|<0.001
70943105|NCT03303521|141386461|SUPERIORITY||Odds Ratio (OR)|35.51|||<|0.001|TWO_SIDED|95.0|8.53|309.48|||Fisher Exact|||||309.48|8.53|<0.001
70943106|NCT02642159|141386473|SUPERIORITY||LS Mean Difference|-32.5|||<|0.0001|TWO_SIDED|97.5|-38.1|-27.0||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|Alirocumab group was compared to usual care group using an appropriate contrast statement.||-27.0|-38.1|<0.0001
70943107|NCT02642159|141386474|SUPERIORITY||LS Mean Difference|-33.3|||<|0.0001|TWO_SIDED|97.5|-46.6|-19.9||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Alirocumab group was compared to usual care group for the intent to prescribe fenofibrate using an appropriate contrast statement.||-19.9|-46.6|<0.0001
70943108|NCT02642159|141386475|SUPERIORITY||LS Mean Difference|-43.0|||<|0.0001|TWO_SIDED|97.5|-49.7|-36.3||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses for overall ITT analysis. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level.||-36.3|-49.7|<0.0001
70943109|NCT02642159|141386476|SUPERIORITY||LS Mean Difference|-55.7|||<|0.0001|TWO_SIDED|97.5|-71.8|-39.6||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|A separate hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses for ITT-intent to prescribe fenofibrate stratum. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level.||-39.6|-71.8|<0.0001
70943110|NCT02642159|141386477|SUPERIORITY||LS Mean Difference|-26.1|||<|0.0001|TWO_SIDED|97.5|-31.5|-20.7||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).||-20.7|-31.5|<0.0001
70943111|NCT02642159|141386478|SUPERIORITY||LS Mean Difference|-27.4|||<|0.0001|TWO_SIDED|97.5|-40.0|-14.8||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT-intent to prescribe fenofibrate stratum was statistically significant).||-14.8|-40.0|<0.0001
70943112|NCT02642159|141386479|SUPERIORITY||LS Mean Difference|-34.7|||<|0.0001|TWO_SIDED|97.5|-40.8|-28.6||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).||-28.6|-40.8|<0.0001
70854620|NCT03567343|141197761|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.41||||0.5242|TWO_SIDED|95.0|-0.88|1.71|||Paired T-test|||Change in number of lapses||1.71|-0.88|0.5242
70854621|NCT03567343|141197762|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.67||||0.8106|TWO_SIDED|95.0|-4.92|6.25|||Paired T-test|||POMS-TMD||6.25|-4.92|0.8106
70943113|NCT02642159|141386480|SUPERIORITY||LS Mean Difference|-49.7|||<|0.0001|TWO_SIDED|97.5|-63.7|-35.8||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT-intent to prescribe fenofibrate stratum was statistically significant).||-35.8|-63.7|<0.0001
70943114|NCT02642159|141386481|SUPERIORITY||LS Mean Difference|-32.3|||<|0.0001|TWO_SIDED|97.5|-37.3|-27.2||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).||-27.2|-37.3|<0.0001
70943115|NCT02642159|141386482|SUPERIORITY||LS Mean Difference|-35.2|||<|0.0001|TWO_SIDED|97.5|-47.4|-22.9||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT- intent to prescribe fenofibrate stratum was statistically significant).||-22.9|-47.4|<0.0001
70943116|NCT02642159|141386483|SUPERIORITY||LS Mean Difference|-24.6|||<|0.0001|TWO_SIDED|97.5|-28.8|-20.3||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).||-20.3|-28.8|<0.0001
70943117|NCT02642159|141386484|SUPERIORITY||LS Mean Difference|-25.3|||<|0.0001|TWO_SIDED|97.5|-35.4|-15.1||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT- intent to prescribe fenofibrate stratum was statistically significant).||-15.1|-35.4|<0.0001
70943118|NCT02642159|141386485|SUPERIORITY||Adjusted Mean Difference|-27.4|||<|0.0001|TWO_SIDED|97.5|-34.6|-20.1||Threshold for significance \<=0.025.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).||-20.1|-34.6|<0.0001
70943119|NCT02642159|141386486|SUPERIORITY||Adjusted Mean Difference|-22.8||||0.004|TWO_SIDED|97.5|-40.6|-5.0||Threshold for significance \<=0.025.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT- intent to prescribe fenofibrate stratum was statistically significant).||-5.0|-40.6|0.0040
70943120|NCT02642159|141386487|SUPERIORITY||Adjusted Mean Difference|-4.2||||0.2191|TWO_SIDED|97.5|-11.8|3.4||Threshold for significance \<=0.025.|Regression, Robust|Multiple imputation approach followed by robust regression.|Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).||3.4|-11.8|0.2191
70943121|NCT02642159|141386488|SUPERIORITY||Adjusted Mean Difference|9.0||||0.2651|TWO_SIDED|97.5|-9.1|27.1||Threshold for significance \<=0.025.|Regression, Robust|Multiple imputation approach followed by robust regression.||Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT- intent to prescribe fenofibrate stratum was statistically significant).|Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|27.1|-9.1|0.2651
71080035|NCT04227405|141667033|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Active Copinng subscale||||>.05
71080036|NCT04227405|141667033|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Plannning subscale for the control group||||>.05
71080037|NCT04227405|141667033|SUPERIORITY||Slope|-0.15|STANDARD_ERROR_OF_MEAN|0.06|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Planning subscale for the intervention group||||<.10
71080038|NCT04227405|141667033|SUPERIORITY||Slope|-0.17|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Planning subscale||||>.05
70854622|NCT03567343|141197762|EQUIVALENCE|P\<0.05|Mean Difference (Net)|3.87||||0.1427|TWO_SIDED|95.0|-1.35|9.09|||Paired T-test|||POMS-TMD||9.09|-1.35|0.1427
70854623|NCT03567343|141197762|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.05||||0.9344|TWO_SIDED|95.0|-1.11|1.21|||Paired T-test|||POMS-Tension||1.21|-1.11|0.9344
70854624|NCT03567343|141197762|EQUIVALENCE|P\<0.05|Mean Difference (Net)|1.54||||0.0092|TWO_SIDED|95.0|0.4|2.69|||Paired T-test|||POMS-Tension||2.69|0.40|0.0092
70854625|NCT03567343|141197762|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.29||||0.755|TWO_SIDED|95.0|-1.55|2.12|||Paired T-test|||POMS-Depression||2.12|-1.55|0.755
70854626|NCT03567343|141197762|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.74||||0.2131|TWO_SIDED|95.0|-0.44|1.92|||Paired T-test|||POMS-Depression||1.92|-0.44|0.2131
70854627|NCT03567343|141197762|EQUIVALENCE|P\<0.05|Mean Difference (Net)|1.19||||0.06|TWO_SIDED|95.0|-0.05|2.43|||Paired T-test|||POMS-Anger||2.43|-0.05|0.06
70854628|NCT03567343|141197762|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.24||||0.4117|TWO_SIDED|95.0|-0.34|0.82|||Paired T-test|||POMS-Anger||0.82|-0.34|0.4117
70854629|NCT03567343|141197762|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.05||||0.9548|TWO_SIDED|95.0|-1.64|1.73|||Paired T-test|||POMS-Fatigue||1.73|-1.64|0.9548
70854630|NCT03567343|141197762|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.48||||0.4649|TWO_SIDED|95.0|-0.83|1.79|||Paired T-test|||POMS-Fatigue||1.79|-0.83|0.4649
70854631|NCT03567343|141197762|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.26||||0.5656|TWO_SIDED|95.0|-0.65|1.18|||Paired T-test|||POMS-Confusion||1.18|-0.65|0.5656
70854632|NCT03567343|141197762|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.33||||0.4307|TWO_SIDED|95.0|-0.5|1.15|||Paired T-test|||POMS-Confusion||1.15|-0.5|0.4307
70854633|NCT03567343|141197762|EQUIVALENCE|P\<0.05|Mean Difference (Net)|1.17||||0.2651|TWO_SIDED|95.0|-0.92|3.25|||Paired T-test|||POMS-Vigor||3.25|-0.92|0.2651
70854634|NCT03567343|141197762|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.54||||0.5992|TWO_SIDED|95.0|-2.61|1.53|||Paired T-test|||POMS-Vigor||1.53|-2.61|0.5992
70854635|NCT03567343|141197763|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.37||||0.6869|TWO_SIDED|95.0|-1.48|2.22|||Paired T-test|||||2.22|-1.48|0.6869
70854636|NCT03567343|141197763|EQUIVALENCE|P\<0.05|Mean Difference (Net)|1.39||||0.1769|TWO_SIDED|95.0|-0.65|3.43|||Paired T-test|||||3.43|-0.65|0.1769
70854637|NCT03567343|141197764|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.51||||0.6422|TWO_SIDED|95.0|-1.69|2.72|||Paired T-test|||||2.72|-1.69|0.6422
70854638|NCT03567343|141197764|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.63||||0.4106|TWO_SIDED|95.0|-0.9|2.16|||Paired T-test|||||2.16|-0.9|0.4106
70854639|NCT03567343|141197765|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.23||||0.5672|TWO_SIDED|95.0|-1.05|0.58|||Paired T-test|||||0.58|-1.05|0.5672
70854640|NCT03567343|141197765|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.11||||0.805|TWO_SIDED|95.0|-0.77|0.99|||Paired T-test|||||0.99|-0.77|0.805
70854641|NCT03567343|141197766|EQUIVALENCE|P\<0.05|Median Difference (Net)|-43.09||||0.1236|TWO_SIDED|95.0|-98.43|12.26|||Paired T-test|||Change in lapse time||12.26|-98.43|.1236
70854642|NCT03567343|141197766|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-2.01||||0.8241|TWO_SIDED|95.0|-20.13|16.11|||Paired T-test|||Change in lapse time||16.11|-20.13|.8241
70854643|NCT00043550|141197798|SUPERIORITY|The proposed sample size had at least 80% power to detect effect sizes of 0.36 between the two active treatment conditions and placebo during the active phase. These power calculations were based on a priori values of within-subject correlation of 0.50, 10% attrition, and 6 assessment points.|Slope|1.0||||0.95|TWO_SIDED|||||Overall significant effect for treatment, as well as the two moderating effects, used a Bonferroni-corrected alpha level of 0.0167 (0.05/3).|HLM|||Comparison of conditions||||.95
70854644|NCT00043550|141197798|SUPERIORITY||||||<|0.0001|||||||HLM|||effects of conditions over time||||<.0001
70854645|NCT00043550|141197798|SUPERIORITY||Slope|0.03|||||TWO_SIDED|95.0|-0.35|0.41||||||||.41|-.35|
70854646|NCT00043550|141197798|SUPERIORITY||Slope|0.06|||||TWO_SIDED|95.0|-0.33|0.45||||||||.45|-.33|
70854647|NCT03259620|141197803|SUPERIORITY|||||||0.2587|||||||Cochran-Mantel-Haenszel|||||||0.2587
70854648|NCT00827931|141197808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-99.9|STANDARD_ERROR_OF_MEAN|131.99||0.46|TWO_SIDED|95.0|-371.4|171.5|||t-test, 2 sided|||The null hypothesis applicable to the efficacy analyses was that there was no difference between tranexamic acid plus standard care compared to standard care alone. The alternative hypothesis was that there was a difference.||171.5|-371.4|0.460
70854649|NCT00827931|141197809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-83.6|STANDARD_ERROR_OF_MEAN|147.61||0.579|TWO_SIDED|95.0|-386.5|219.3|||t-test, 2 sided|||The null hypothesis applicable to the efficacy analyses was that there was no difference between tranexamic acid plus standard care compared to standard care alone. The alternative hypothesis was that there was a difference.||219.3|-386.5|0.579
70854650|NCT00827931|141197810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-183.5|STANDARD_ERROR_OF_MEAN|239.19||0.452|TWO_SIDED|95.0|-672.6|305.5|||t-test, 2 sided|||The null hypothesis applicable to the efficacy analyses was that there was no difference between tranexamic acid plus standard care compared to standard care alone. The alternative hypothesis was that there was a difference.||305.5|-672.6|0.452
70854651|NCT00827931|141197811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-417.7|STANDARD_ERROR_OF_MEAN|152.51||0.01|TWO_SIDED|95.0|-729.4|-106.1|||t-test, 2 sided|||The null hypothesis applicable to the efficacy analyses was that there was no difference between tranexamic acid plus standard care compared to standard care alone. The alternative hypothesis was that there was a difference.||-106.1|-729.4|0.010
70854652|NCT00827931|141197812|SUPERIORITY_OR_OTHER|||||||0.701|TWO_SIDED||||||Fisher Exact|||Fisher's exact test was used at 5% level of significance.||||0.701
70854653|NCT02081859|141197834|OTHER|||||||0.41|||||||Chi-squared|||||||0.41
70854654|NCT02081859|141197835|OTHER|||||||0.21|||||||Chi-squared|||||||0.21
70854655|NCT00492063|141197838|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with HI titer ≥40 in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain A/H1N1, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain A/H1N1 after one vaccination in adults.||3|-3|
71080039|NCT04227405|141667033|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Instrumental Support subscale for the control group||||>.05
70943122|NCT00187135|141386512|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||To adjust for multiple comparisons, p-values less than 0.0167 are considered statistically significant.|McNemar|||The study was designed to achieve statistical power of 80% for this comparison. Due to the early termination of the study, the sample size needed to ensure adequate statistical power for this comparison was not obtained.||||0.5
71080040|NCT04227405|141667033|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Instrumental Support subscale for the intervention group||||>.05
71080041|NCT04227405|141667033|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Instrumental Support subscale||||>.05
71080042|NCT04227405|141667035|SUPERIORITY||Slope|-0.3|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED||||||Multilevel modeling||Changes from pre-test to Follow-up in the Emotional Abuse subscale for the control group|Changes from pre-test to posttest in the Acceptance subscale for the control group||||<.05
71080043|NCT04227405|141667035|SUPERIORITY||Slope|0.47|STANDARD_ERROR_OF_MEAN|0.16|<|0.01|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Emotional Abuse subscale for the control group||||<.01
71080044|NCT04227405|141667035|SUPERIORITY||Slope|0.77|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Acceptance subscale||||<.001
71080045|NCT04227405|141667035|SUPERIORITY||Slope|-0.17|STANDARD_ERROR_OF_MEAN|0.13|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Active Coping subscale for the control group||||>.05
71080046|NCT04227405|141667035|SUPERIORITY||Slope|0.3|STANDARD_ERROR_OF_MEAN|0.17|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Active Coping subscale for the intervention group||||<.10
71080047|NCT04227405|141667035|SUPERIORITY||Slope|0.47|STANDARD_ERROR_OF_MEAN|0.2|<|0.05|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Active Coping subscale||||<.05
71080048|NCT04227405|141667035|SUPERIORITY||Slope|-0.38|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Planning subscale for the control group||||<.05
71080049|NCT04227405|141667035|SUPERIORITY||Slope|0.37|STANDARD_ERROR_OF_MEAN|0.15|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Planning subscale for the Intervention group||||<.05
71080050|NCT04227405|141667035|SUPERIORITY||Slope|0.74|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Planning subscale||||<.001
70943123|NCT00187135|141386512|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||To adjust for multiple comparisons, p-values less than 0.0167 are considered statistically significant.|McNemar|||The study was designed to achieve statistical power of 80% for this comparison. The sample size needed to ensure adequate statistical power for this comparison was obtained.||||0.5
71080051|NCT04227405|141667035|SUPERIORITY||Slope|-0.11|STANDARD_ERROR_OF_MEAN|0.12|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Instrumental Support subscale for the control group||||>.05
71080052|NCT04227405|141667035|SUPERIORITY||Slope|0.49|STANDARD_ERROR_OF_MEAN|0.16|<|0.01|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Instrumental Support subscale for the intervention group||||<.01
71080053|NCT04227405|141667035|SUPERIORITY||Slope|0.6|STANDARD_ERROR_OF_MEAN|0.19|<|0.01|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Instrumental Support subscale||||<.01
71080054|NCT04227405|141667036|SUPERIORITY||Slope|-0.25|STANDARD_ERROR_OF_MEAN|0.15|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Acceptance subscale for the control group||||>.05
71080055|NCT04227405|141667036|SUPERIORITY||Slope|0.52|STANDARD_ERROR_OF_MEAN|0.19|<|0.01|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Acceptance subscale for the intervention group||||<.01
71118540|NCT04376684|141741993|OTHER||Odds Ratio (OR)|1.17||||0.183|TWO_SIDED|95.0|0.84|1.63||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.63|0.84|0.1830
71118541|NCT04376684|141741994|OTHER||Odds Ratio (OR)|1.51||||0.0831|TWO_SIDED|95.0|0.95|2.39||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||2.39|0.95|0.0831
71118542|NCT04376684|141741995|OTHER||Odds Ratio (OR)|1.29||||0.2557|TWO_SIDED|95.0|0.83|2.0||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||2.00|0.83|0.2557
71118543|NCT04376684|141741996|OTHER||Odds Ratio (OR)|1.04||||0.856|TWO_SIDED|95.0|0.67|1.61||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.61|0.67|0.8560
71118544|NCT04376684|141741997|OTHER||Odds Ratio (OR)|1.07||||0.7533|TWO_SIDED|95.0|0.69|1.66||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.66|0.69|0.7533
71118545|NCT04376684|141741998|OTHER||Hazard Ratio (HR)|1.12||||0.0959|TWO_SIDED|95.0|0.95|1.32||p-value is from a one-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized and age group as randomized.|||1.32|0.95|0.0959
71118546|NCT04376684|141741999|OTHER||Hazard Ratio (HR)|1.12||||0.4421|TWO_SIDED|95.0|0.84|1.5||p-value is generated from a two-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized, sex as randomized and age.|||1.50|0.84|0.4421
71118547|NCT04376684|141742000|OTHER||Odds Ratio (OR)|1.14||||0.2814|TWO_SIDED|95.0|0.73|1.8||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.80|0.73|0.2814
71118548|NCT04376684|141742001|OTHER||Odds Ratio (OR)|1.04||||0.3901|TWO_SIDED|95.0|0.77|1.42||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.42|0.77|0.3901
71118549|NCT04376684|141742002|OTHER||Odds Ratio (OR)|1.01||||0.4763|TWO_SIDED|95.0|0.75|1.36||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.36|0.75|0.4763
71118550|NCT04376684|141742003|OTHER||Odds Ratio (OR)|1.14||||0.1973|TWO_SIDED|95.0|0.84|1.56||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.56|0.84|0.1973
71118551|NCT04376684|141742004|OTHER||Odds Ratio (OR)|1.21||||0.1173|TWO_SIDED|95.0|0.88|1.67||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.67|0.88|0.1173
70943124|NCT00187135|141386513|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||To adjust for multiple comparisons, p-values less than 0.0167 are considered statistically significant.|McNemar|||The study was designed to achieve statistical power of 80% for this comparison. Due to the early termination of the study, the sample size needed to ensure adequate statistical power for this comparison was not obtained.||||0.5
71118552|NCT04376684|141742005|OTHER||Odds Ratio (OR)|3.98||||0.0037|TWO_SIDED|95.0|1.57|10.13||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||10.13|1.57|0.0037
71118553|NCT04376684|141742006|OTHER||Odds Ratio (OR)|1.26||||0.3581|TWO_SIDED|95.0|0.77|2.06||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||2.06|0.77|0.3581
71118554|NCT04376684|141742007|OTHER||Odds Ratio (OR)|0.99||||0.9621|TWO_SIDED|95.0|0.63|1.54||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.54|0.63|0.9621
70943125|NCT00187135|141386514|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||GEE Model|||The generalized estimation equation (GEE) approach by Liang and Zeger was used to model the effects of 20% change in heart rate (HR) on pain (Y/N) while controlling for treatment.||||0.87
70854656|NCT00492063|141197838|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with HI titer ≥40 in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain A/H3N2, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|0.0|||||TWO_SIDED|95.0|-1.0|2.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain A/H3N2 after one vaccination in adults.||2|-1|
70854657|NCT00492063|141197838|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with HI titer ≥40 in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain B, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain B after one vaccination in adults.||3|-3|
70854658|NCT00492063|141197838|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with HI titer ≥40 in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain A/H1N1, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|-1.0|||||TWO_SIDED|95.0|-4.0|3.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain A/H1N1 after one vaccination in the elderly population.||3|-4|
70854659|NCT00492063|141197838|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with HI titer ≥40 in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain A/H3N2, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|-1.0|||||TWO_SIDED|95.0|-2.0|1.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain A/H3N2 after one vaccination in the elderly population.||1|-2|
70943126|NCT00187135|141386515|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||GEE Model|||The generalized estimation equation (GEE) approach by Liang and Zeger was used to model the effects of 20% change in respiratory rate (RR) on pain (Y/N) while controlling for treatment.||||0.67
70943127|NCT00187135|141386516|SUPERIORITY_OR_OTHER|||||||0.52||95.0|||||GEE Model|||The generalized estimation equation (GEE) approach by Liang and Zeger was used to model the effects of 20% change in blood presure (BP) on pain (Y/N) while controlling for treatment.||||0.52
70943128|NCT00187135|141386517|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||GEE Model|||The generalized estimation equation (GEE) approach by Liang and Zeger was used to model the effects of motion (Y/N)on pain (Y/N) while controlling for treatment.||||0.99
70943129|NCT01954771|141386523|SUPERIORITY_OR_OTHER||Correlation coefficient|0.726|||<|0.001|TWO_SIDED||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from SMBG measurements.||||<0.001
70943130|NCT01954771|141386523|SUPERIORITY_OR_OTHER||Correlation coefficient|0.522||||0.004|TWO_SIDED||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from SMBG measurements.||||0.004
70943131|NCT01954771|141386523|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.784|||<|0.001|TWO_SIDED||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from SMBG measurements.||||<0.001
70943132|NCT01954771|141386523|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.533||||0.011|TWO_SIDED||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from CGMS measurements.||||0.011
70943133|NCT01954771|141386523|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.479||||0.009|TWO_SIDED||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from CGMS measurements.||||0.009
70943134|NCT01954771|141386523|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.801|||<|0.001|TWO_SIDED||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from CGMS measurements.||||<0.001
70943135|NCT04098497|141386556|OTHER|||||||0.09|||||||t-test, 2 sided|t = 1.74, df = 28||baseline to day 42 comparison||||0.09
70943136|NCT04098497|141386557|OTHER|||||||0.09|||||||t-test, 2 sided|t = 1.75, df = 28||baseline to day 42||||0.09
70943137|NCT04098497|141386558|SUPERIORITY|||||||0.13|||||||Regression, Linear|β = 0.14, z = 1.51||Mean difference between receiving the intervention and not receiving the intervention at each time point.||||0.13
71080056|NCT04227405|141667036|SUPERIORITY||Slope|0.78|STANDARD_ERROR_OF_MEAN|0.24|<|0.01|TWO_SIDED||||||Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Acceptance subscale|The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|||<.01
71080057|NCT04227405|141667036|SUPERIORITY||Slope|0.09|STANDARD_ERROR_OF_MEAN|0.16|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Active Coping subscale for the control group||||>.05
71080058|NCT04227405|141667036|SUPERIORITY||Slope|0.36|STANDARD_ERROR_OF_MEAN|0.2|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Active Coping subscale for the intervention group||||<.10
71080059|NCT04227405|141667036|SUPERIORITY||Slope|0.4|STANDARD_ERROR_OF_MEAN|0.25|<|0.1|TWO_SIDED||||||Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Active Coping subscale||||<.10
71080060|NCT04227405|141667036|SUPERIORITY||Slope|-0.31|STANDARD_ERROR_OF_MEAN|0.15|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Planning subscale for the control group||||<.10
70943138|NCT04098497|141386559|SUPERIORITY|||||||0.007|||||||Regression, Linear|β = 0.38, z = 2.71||Mean difference between receiving the intervention and not receiving the intervention at each time point.||||0.007
71080061|NCT04227405|141667036|SUPERIORITY||Slope|0.4|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Planning subscale for the intervention group||||<.05
70943139|NCT04098497|141386560|SUPERIORITY|||||||0.57|||||||Regression, Linear|β = 0.03, z = 0.58||Mean difference between receiving the intervention and not receiving the intervention at each time point.||||0.57
70943140|NCT04098497|141386561|SUPERIORITY|||||||0.25|||||||Regression, Linear|β = 0.06, z = 1.15||Mean difference between receiving the intervention and not receiving the intervention at each time point.||||0.25
71080062|NCT04227405|141667036|SUPERIORITY||Slope|0.71|STANDARD_ERROR_OF_MEAN|0.23|<|0.01|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Planning subscale||||<.01
70943141|NCT00297778|141386562|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9||||0.0103||95.0|-3.4|-0.5|||ANCOVA|||||-0.5|-3.4|0.0103
70943142|NCT00297778|141386563|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.758||||0.0535||95.0|0.992|3.115|||Regression, Logistic|||||3.115|0.992|0.0535
70943143|NCT00297778|141386564|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.0346||95.0|-1.5|-0.1|||ANCOVA|||||-0.1|-1.5|0.0346
70943144|NCT00297778|141386565|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.5244||95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|-1|0.5244
70943145|NCT00297778|141386566|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.141||95.0|0.0|0.0|||van Elteren (country stratification)|||||0|0|0.141
70943146|NCT00297778|141386567|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.003||95.0|-1.9|-0.4|||ANCOVA|||||-0.4|-1.9|0.003
70943147|NCT00297778|141386568|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2||||0.0034||95.0|-3.7|-0.7|||ANCOVA|||||-0.7|-3.7|0.0034
70943148|NCT00297778|141386569|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.4||||0.0007||95.0|-5.4|-1.5|||ANCOVA|||||-1.5|-5.4|0.0007
70943149|NCT00297778|141386570|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.821||||0.006||95.0|1.187|2.794|||Regression, Logistic|||||2.794|1.187|0.006
70943150|NCT00297778|141386571|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.3||||0.1925||95.0|-3.3|0.8|||van Elteren (country stratification)|||||0.8|-3.3|0.1925
70943151|NCT00297778|141386572|SUPERIORITY_OR_OTHER||Hodges-Lehmann est of diff in medians|0.04||||0.0337||95.0|0.0|0.09|||Wilcoxon rank sum (Van Elteren's test)|||||0.09|0|0.0337
70943152|NCT00297778|141386573|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.8471||95.0|-5.6|4.6|||ANCOVA|||||4.6|-5.6|0.8471
70943153|NCT00297778|141386574|SUPERIORITY_OR_OTHER||Hodges-Lehmann est of diff in medians|0.0||||0.141|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon rank sum (Van Elteren's test)||95% Confidence interval is Distribution-free Confidence Interval (Moses).|N's exclude patients from the analysis set with incomplete data||0.0|0.0|0.1410
70943154|NCT00297778|141386575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.5231|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||N's exclude patients from the analysis set with incomplete data||0.2|-0.5|0.5231
71080063|NCT04227405|141667036|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.16|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Instrumental Support subscale for the control group||||>.05
71080064|NCT04227405|141667036|SUPERIORITY||Slope|0.64|STANDARD_ERROR_OF_MEAN|0.19|<|0.01|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Instrumental Support subscale for the intervention group||||<.01
71080065|NCT04227405|141667036|SUPERIORITY||Slope|0.66|STANDARD_ERROR_OF_MEAN|0.24|<|0.01|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Instrumental Support subscale||||<.01
71080066|NCT04227405|141667036|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Acceptance subscale for the control group||||>.05
71080067|NCT04227405|141667036|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Acceptance subscale for the interventionn group||||>.05
71080068|NCT04227405|141667036|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Acceptance subscale||||>.05
71080069|NCT04227405|141667036|SUPERIORITY||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Active Coping subscale for the control group||||>.05
71080070|NCT04227405|141667036|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Active Coping in the intervention group||||>.05
71080071|NCT04227405|141667036|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Active Coping subscale||||>.05
71080072|NCT04227405|141667036|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Planning subscale for the control group||||>.05
71080073|NCT04227405|141667036|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Planning subscale for the intervention group||||>.05
71080074|NCT04227405|141667036|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in Planning subscale||||>.05
70943155|NCT03280108|141386578|NON_INFERIORITY|Non-inferiority based on the observed 95% Upper Confidence Limit of the difference in Least Squares Means (LSM) between the 2 groups (TFNT00 - SN60AT). Non-inferiority margin = 0.10 logMAR.|Least Squares Mean Difference|0.024|STANDARD_ERROR_OF_MEAN|0.0103|||ONE_SIDED|95.0||0.041||||||||0.041||
71080075|NCT04227405|141667036|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Instrumental Support subscale for the control group||||>.05
71080076|NCT04227405|141667036|SUPERIORITY||Slope|-0.15|STANDARD_ERROR_OF_MEAN|0.06|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Instrumental Support subscale for the intervention group||||<.10
71080077|NCT04227405|141667036|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Instrumental Supportt subscale||||>.05
71080078|NCT04227405|141667038|SUPERIORITY||Slope|-1.41|STANDARD_ERROR_OF_MEAN|0.49|<|0.05|TWO_SIDED||||||Multilevel modeling|||Changes from pre-test to posttest for the control group|A positive value indicates an increase while a negative value indicates a decrease|||<.05
70943156|NCT03280108|141386579|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70943157|NCT03280108|141386585|SUPERIORITY||Least Squares Mean Difference|-0.257|STANDARD_ERROR_OF_MEAN|0.0153|<|0.001|TWO_SIDED|95.0|-0.287|-0.227|||Mixed Models Analysis|||||-0.227|-0.287|<0.001
70943158|NCT03280108|141386586|SUPERIORITY||Mantel-Haenszel common difference|71.2|||||TWO_SIDED|95.0|61.87|80.46||||||||80.46|61.87|
70943159|NCT02109107|141386611|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|t=21.33; df=53||||||<.0001
70943160|NCT02109107|141386612|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|t=2.95; df=53||||||<0.05
70943161|NCT02109107|141386613|SUPERIORITY_OR_OTHER||||||<|0.005|TWO_SIDED||||||t-test, 2 sided|t+3.34; df=53||||||<0.005
70943162|NCT00607789|141386622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3|STANDARD_DEVIATION|1.7|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||The primary efficacy analysis was a longitudinal analysis comparing the rate of change of binge day frequency during the treatment period between groups. The same analysis was applied to binge episode frequency, weight, BMI, and scores on the CGI-Severity, YBOCS-BE, and IDS scales. The difference in rate of change was estimated by random regression methods||||<0.05
70943163|NCT05401149|141386638|OTHER|Odds Ratio (OR) (95% CI) and P values for this outcome were derived from the conditional logistic regression models with stratification by matching pairs and adjustment for prior modified Rankin Scale (mRS) score (≤ 1 or not), baseline National Institutes of Health Stroke Scale (NIHSS) score, and time from symptom onset to hospital admission.|Odds Ratio (OR)|1.87|||<|0.001|TWO_SIDED|95.0|1.35|2.59|||Regression, Logistic||IV rt-PA cohort/Non-reperfusion cohort|||2.59|1.35|<0.001
70943164|NCT05401149|141386639|OTHER|OR (95% CI) and P values were derived from the conditional logistic regression models with stratification by matching pairs and adjustment for prior mRS score (≤ 1 or not), baseline NIHSS score, and time from symptom onset to hospital admission.|Odds Ratio (OR)|1.43||||0.054|TWO_SIDED|95.0|0.99|2.06|||Regression, Logistic||IV rt-PA cohort/Non-reperfusion cohort|||2.06|0.99|0.054
70954230|NCT00688870|141411075|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|5.82|||||TWO_SIDED|95.0|4.42|7.67|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 6A||7.67|4.42|
71080079|NCT04227405|141667038|SUPERIORITY||Slope|2.02|STANDARD_ERROR_OF_MEAN|0.69|<|0.01|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest for the intervention group||||<.01
71080080|NCT04227405|141667038|SUPERIORITY||Slope|-0.62|STANDARD_ERROR_OF_MEAN|0.83|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from pre-test to post-test t in the intervention group were not significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test||||>.05
71080081|NCT04227405|141667039|SUPERIORITY||Slope|-1.48|STANDARD_ERROR_OF_MEAN|0.6|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up for the control group||||>.05
71080082|NCT04227405|141667039|SUPERIORITY||Slope|-1.5|STANDARD_ERROR_OF_MEAN|0.82|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up for the intervention group||||<.10
71080083|NCT04227405|141667039|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|1.01|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up||||>.05
71080084|NCT04227405|141667039|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up for the control group||||>.05
71080085|NCT04227405|141667039|SUPERIORITY||Slope|-0.52|STANDARD_ERROR_OF_MEAN|0.23|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up for the control group||||>.05
71080086|NCT04227405|141667039|SUPERIORITY||Slope|-0.6|STANDARD_ERROR_OF_MEAN|0.03|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up||||>.05
71080087|NCT04227405|141667041|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|1.16|>|0.05|TWO_SIDED|||||No adjustment for p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in Difficulties in Emotion Regulation for the control group||||>.05
71080088|NCT04227405|141667041|SUPERIORITY||Slope|-3.07|STANDARD_ERROR_OF_MEAN|1.51|<|0.05|TWO_SIDED|||||No adjustment for p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group||||<.05
71080089|NCT04227405|141667041|SUPERIORITY||Slope|-2.74|STANDARD_ERROR_OF_MEAN|1.85|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to pos-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test||||>.05
71080090|NCT04227405|141667042|SUPERIORITY||Slope|-0.7|STANDARD_ERROR_OF_MEAN|1.41|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling|||Change from pre-test to follow-up for the control group|A positive value indicates an increase while a negative value indicates a decrease|||>.05
71080091|NCT04227405|141667042|SUPERIORITY||Slope|-2.74|STANDARD_ERROR_OF_MEAN|1.79|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the control group||||>.05
71080092|NCT04227405|141667042|SUPERIORITY||Slope|-2.04|STANDARD_ERROR_OF_MEAN|2.24|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up||||>.05
71080093|NCT04227405|141667042|SUPERIORITY||Slope|0.36|STANDARD_ERROR_OF_MEAN|0.46|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the control group||||>.05
71080094|NCT04227405|141667042|SUPERIORITY||Slope|-0.33|STANDARD_ERROR_OF_MEAN|0.5|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the control group||||>.05
71080095|NCT04227405|141667042|SUPERIORITY||Slope|-0.69|STANDARD_ERROR_OF_MEAN|0.68|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up||||>.05
71080096|NCT04227405|141667044|SUPERIORITY||Slope|-0.39|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in psychological agggression subscale for the control group||||<.001
71080097|NCT04227405|141667044|SUPERIORITY||Slope|-0.73|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in psychological aggression subscale for the intervention group||||<.001
71080098|NCT04227405|141667044|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.17|<|0.1|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to pos-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in Psychological Aggression subscale||||<.10
71080099|NCT04227405|141667044|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.09|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling|||Change from pre-test to post-test in physical assault subscale for the control group|A positive value indicates an increase while a negative value indicates a decrease|||>.05
70943165|NCT05401149|141386640|OTHER|OR (95% CI) and P values were derived from the conditional logistic regression models with stratification by matching pairs and adjustment for prior mRS score (≤ 1 or not), baseline NIHSS score, and time from symptom onset to hospital admission.|Odds Ratio (OR)|2.07||||0.097|TWO_SIDED|95.0|0.88|4.86|||Regression, Logistic||IV rt-PA cohort/Non-reperfusion cohort|||4.86|0.88|0.097
70943166|NCT05401149|141386641|OTHER|Odds Ratio (OR) (95% CI) and P values for this outcome were derived from the conditional logistic regression models with stratification by matching pairs and adjustment for prior modified Rankin Scale (mRS) score (≤ 1 or not), baseline National Institutes of Health Stroke Scale (NIHSS) score, and time from symptom onset to hospital admission.|Odds Ratio (OR)|2.02|||<|0.001|TWO_SIDED|95.0|1.48|2.75|||Regression, Logistic||IV rt-PA cohort/Non-reperfusion cohort|||2.75|1.48|<0.001
70943167|NCT05401149|141386642|OTHER|Odds Ratio (OR) (95% CI) and P values for this outcome were derived from the ordinal logistic regression models with adjustment for prior modified Rankin Scale (mRS) score (≤ 1 or not), baseline National Institutes of Health Stroke Scale (NIHSS) score, and time from symptom onset to hospital admission.|Odds Ratio (OR)|0.77||||0.007|TWO_SIDED|95.0|0.64|0.93|||Regression, Logistic||IV rt-PA cohort/Non-reperfusion cohort|||0.93|0.64|0.007
70943168|NCT05401149|141386643|OTHER|Hazard ratio (HR) (95% Confidence Interval) and P values were derived from the cox proportional hazards models with stratification by matching pairs and adjustment for prior mRS score (≤ 1 or not), baseline NIHSS score, and time from symptom onset to hospital admission.|Hazard Ratio (HR)|1.26||||0.077|TWO_SIDED|95.0|0.98|1.64|||Regression, Cox||IV rt-PA cohort/Non-reperfusion cohort|||1.64|0.98|0.077
70943169|NCT02264353|141386644|SUPERIORITY|||||||0.576|||||||t-test, 2 sided|||||||0.576
71080100|NCT04227405|141667044|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in the physical assault subscale for the intervention group||||<.001
71080101|NCT04227405|141667044|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.14|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were significantly different from the change from pre-test to pos-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in Physical Assault subscale||||<.05
71080102|NCT04227405|141667045|SUPERIORITY||Slope|-0.47|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in the psychological aggression subscale for the control group||||<.001
70943170|NCT02264353|141386645|OTHER|||||||0.394|||||||Wilcoxon (Mann-Whitney)|||||||0.394
71080103|NCT04227405|141667045|SUPERIORITY||Slope|-0.77|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in the Psychological Aggression subscale for the intervention group||||<.001
71080104|NCT04227405|141667045|SUPERIORITY||Slope|-0.3|STANDARD_ERROR_OF_MEAN|0.21|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up inn the psychological aggression subscale||||>.05
71080105|NCT04227405|141667045|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.04|<|0.1|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the control group in the psychological aggression subscale||||<.10
71080106|NCT04227405|141667045|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the intervention group for the psychological aggresssion subscale||||>.05
71080107|NCT04227405|141667045|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up in the psychological aggression subscale||||>.05
70854660|NCT00492063|141197838|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with HI titer ≥40 in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain B, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain B after one vaccination in the elderly population.||4|-2|
70943171|NCT02264353|141386646|SUPERIORITY|||||||0.089|||||||t-test, 2 sided|||||||0.089
71080108|NCT04227405|141667045|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.12|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the control group for the physical assault subscale||||>.05
70943172|NCT01196741|141386656|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.57|TWO_SIDED|95.0|0.65|1.23|||Regression, Cox|||||1.23|0.65|0.57
70943173|NCT01196741|141386657|SUPERIORITY_OR_OTHER|||||||0.81|||||||Regression, Cox|||||||0.81
71080109|NCT04227405|141667045|SUPERIORITY||Slope|-0.4|STANDARD_ERROR_OF_MEAN|0.15|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the control group for the Physical Assault Subscale||||<.05
70854661|NCT00492063|141197839|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain A/H1N1, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|2.0|||||TWO_SIDED|95.0|-3.0|7.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain A/H1N1 in adults.||7|-3|
70854662|NCT00492063|141197839|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain A/H3N2, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|-1.0|||||TWO_SIDED|95.0|-6.0|4.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain A/H3N2 in adults.||4|-6|
70871984|NCT03919799|141229333|SUPERIORITY|MMRM analysis using rank-transformed data, with CRISS score as a dependent variable and treatment, visit, and visit x treatment interaction as fixed effects. Visit was a repeated factor, and analyses were done through week 24.|Least square mean difference|-4.18||||0.1916|TWO_SIDED|95.0|-10.59|2.23||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||2.23|-10.59|0.1916
70943174|NCT01196741|141386660|SUPERIORITY_OR_OTHER|||||||0.0476|||||||Mixed Models Analysis|||||||0.0476
70943175|NCT01196741|141386662|SUPERIORITY_OR_OTHER|||||||0.99|||||||Regression, Cox|||||||0.99
70954231|NCT00688870|141411075|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|96.1|||||TWO_SIDED|95.0|75.6|122.17|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 7F||122.17|75.60|
70871985|NCT03919799|141229335|SUPERIORITY||Least square mean difference|-0.6||||0.771|TWO_SIDED|95.0|-4.7|3.6||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||3.6|-4.7|0.7710
70871986|NCT03919799|141229335|SUPERIORITY||Least square mean difference|4.6||||0.0308|TWO_SIDED|95.0|0.5|8.8||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||8.8|0.5|0.0308
70943176|NCT02273180|141386663|NON_INFERIORITY|Non-inferiority of SAR342434 over Humalog was demonstrated if upper bound of 2-sided 95% confidence interval(CI) of difference between SAR342434 \& Humalog was \<0.3%.Inverse non-inferiority of Humalog over SAR342434 was tested using hierarchical step-down testing procedure:if non-inferiority of SAR342434 over Humalog was demonstrated,then inverse non-inferiority of Humalog over SAR342434 was tested, demonstrated if lower bound of 2-sided 95%CI of difference between SAR342434 \& Humalog was \>-0.3%.|Least Square (LS) Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.071|||TWO_SIDED|95.0|-0.084|0.197|||||SAR342434 vs. Humalog|Analysis was performed using a MMRM approach with treatment groups, randomization strata, visits and treatment-by-visit interaction as fixed categorical effects, and baseline HbA1c value and baseline HbA1c value-by-visit interaction as continuous fixed covariates. An unstructured correlation matrix was used to model within-participant errors.||0.197|-0.084|
70943177|NCT03302559|141386710|OTHER|Testing hypothesis is that the mean change from baseline is zero.|||||<|0.001||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12||||<0.001
70943178|NCT03302559|141386711|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.005||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Forehead)||||0.005
70943179|NCT03302559|141386711|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.02||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Periocular)||||0.02
70943180|NCT03302559|141386711|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.0006||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Cheeks)||||0.0006
70943181|NCT03302559|141386711|OTHER|Testing hypothesis is that the mean change from baseline is zero||||||0.001||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Perioral)||||0.001
70943182|NCT03302559|141386712|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.02||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Forehead)||||0.02
70943183|NCT03302559|141386712|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.006||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Periocular)||||0.006
70943184|NCT03302559|141386712|OTHER|Testing hypothesis is that the mean change from baseline is zero.|||||<|0.001||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Cheeks)||||<0.001
70943185|NCT03302559|141386712|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.5||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Perioral)||||0.5
70943186|NCT03302559|141386713|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.002||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12||||0.002
70943187|NCT03302559|141386714|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.0008||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12||||0.0008
70854663|NCT00492063|141197839|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain B, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|4.0|||||TWO_SIDED|95.0|0.0|8.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain B in adults.||8|0|
70854664|NCT00492063|141197839|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain A/H1N1, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|0.0|||||TWO_SIDED|95.0|-6.0|5.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain A/H1N1 in the elderly population.||5|-6|
70854665|NCT00492063|141197839|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain A/H3N2, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|3.0|||||TWO_SIDED|95.0|-2.0|8.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain A/H3N2 in the elderly population.||8|-2|
71080110|NCT04227405|141667045|SUPERIORITY||Slope|-0.37|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up for the Physical Assault subscale||||<.05
71080111|NCT04227405|141667045|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the control group for the Physical Assault subscale||||>.05
71080112|NCT04227405|141667045|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the intervention group for the Physical Assault subscale||||>.05
71080113|NCT04227405|141667045|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up||||>.05
71080114|NCT04227405|141667047|SUPERIORITY||Slope|-2.12|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group||||<.001
71080115|NCT04227405|141667047|SUPERIORITY||Slope|-4.46|STANDARD_ERROR_OF_MEAN|0.73|<|0.001|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group||||<.001
71080116|NCT04227405|141667047|SUPERIORITY||Slope|-2.34|STANDARD_ERROR_OF_MEAN|0.89|<|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were significantly different from the change from pre-test to pos-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in Time||||<.05
71080117|NCT04227405|141667048|SUPERIORITY||Slope|-1.96|STANDARD_ERROR_OF_MEAN|0.7|<|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the control group||||<.05
71080118|NCT04227405|141667048|SUPERIORITY||Slope|-4.48|STANDARD_ERROR_OF_MEAN|0.88|<|0.001|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the intervention group||||<.001
71080119|NCT04227405|141667048|SUPERIORITY||Slope|-2.52|STANDARD_ERROR_OF_MEAN|1.1|<|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up||||<.05
71080120|NCT04227405|141667048|SUPERIORITY||Slope|-0.16|STANDARD_ERROR_OF_MEAN|0.24|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the control group||||>.05
71080121|NCT04227405|141667048|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.26|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the control group||||>.05
71080122|NCT04227405|141667048|SUPERIORITY||Slope|0.19|STANDARD_ERROR_OF_MEAN|0.35|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up||||>.05
71080123|NCT04227405|141667050|SUPERIORITY||Slope|0.37|STANDARD_ERROR_OF_MEAN|0.24|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group for Supportive Dyadic Coping subscale||||>.05
71118555|NCT04376684|141742008|OTHER||Odds Ratio (OR)|0.83||||0.4167|TWO_SIDED|95.0|0.54|1.29||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.29|0.54|0.4167
70943188|NCT03302559|141386715|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.02||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12||||0.02
70943189|NCT03302559|141386720|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.3||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Normal Skin)||||0.3
70943190|NCT03302559|141386720|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.4||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Target Lesion)||||0.4
70943191|NCT01540162|141386721|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.23||||0.05|TWO_SIDED|95.0|0.05|0.73|||Chi-squared|||||0.73|0.05|0.05
70943192|NCT01699698|141386726|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71080124|NCT04227405|141667050|SUPERIORITY||Slope|0.71|STANDARD_ERROR_OF_MEAN|0.31|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group||||<.05
71080125|NCT04227405|141667050|SUPERIORITY||Slope|0.33|STANDARD_ERROR_OF_MEAN|0.38|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Post-test in the Supportive Dyadic Coping subscale|Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|||>.05
71080126|NCT04227405|141667050|SUPERIORITY||Slope|0.23|STANDARD_ERROR_OF_MEAN|0.3|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group for the common dyadic coping subscale||||>.05
71080127|NCT04227405|141667050|SUPERIORITY||Slope|1.21|STANDARD_ERROR_OF_MEAN|0.39|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group in the Common Dyadic Coping subscale||||<.01
71080128|NCT04227405|141667050|SUPERIORITY||Slope|0.97|STANDARD_ERROR_OF_MEAN|0.47|<|0.1|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test for the Common Dyadic Coping Subscale||||<.10
71080129|NCT04227405|141667050|SUPERIORITY||Slope|-0.74|STANDARD_ERROR_OF_MEAN|0.37|<|0.1|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group in the Negative Dyadic Coping Subscale||||<.10
71080130|NCT04227405|141667050|SUPERIORITY||Slope|-1.14|STANDARD_ERROR_OF_MEAN|0.49|<|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group for the Negative Dyadic Coping subscale||||<.05
71080131|NCT04227405|141667050|SUPERIORITY||Slope|-0.39|STANDARD_ERROR_OF_MEAN|0.6|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test inn the Negative Dyadic Coping Scale||||>.05
71080132|NCT04227405|141667051|SUPERIORITY||Slope|0.57|STANDARD_ERROR_OF_MEAN|0.29|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the control group for the Supportive Dyadic Coping Subscale||||>.05
70943193|NCT02151643|141386731|OTHER|The primary analysis was a linear model which attempted to explain change from Baseline (Visit 7) to Day 29 (Visit 11) in serum phosphate concentration based on log-transformed dose level (assuming that placebo was equally spaced below the lowest dose level), and stratified by pre-randomisation serum phosphate level (\< 7.5 mg/dL or ≥ 7.5 mg/dL). Missing assessments were imputed using the subject's last observed phosphate concentration value (Last Observation Carried Forward \[LOCF\] imputation).||||||0.784|||||||F-test|||"ITT population - statistical analysis of linear model fit using an F-test at the 0.05 level.~It was determined that 150 subjects randomised at a ratio of 8:8:8:13:13 (low dose to high dose, placebo) would have \>90% power to detect either a statistically significant slope for the dose-response relationship, or, if the relationship was not linear, a statistically significant difference between the highest-dose group and the placebo group, using a two-sided 0.05 significance level."||||0.784
71080133|NCT04227405|141667051|SUPERIORITY||Slope|0.7|STANDARD_ERROR_OF_MEAN|0.37|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the intervention group for the Supportive Dyadic Coping Subscale||||<.05
71118556|NCT04376684|141742009|OTHER||Odds Ratio (OR)|0.81||||0.3408|TWO_SIDED|95.0|0.53|1.25||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.25|0.53|0.3408
70943194|NCT02151643|141386731|OTHER|Sensitivity analysis of ITT primary analysis using baseline observation carried forward (BOCF) for any missing Day 29 (Visit 11) serum phosphate values.||||||0.905|||||||F-test|||"ITT population sensitivity analysis using baseline observation carried forward (BOCF) to assess statistical analysis of linear model fit using an F-test at the 0.05 level."||||0.905
70943195|NCT02151643|141386731|OTHER|Sensitivity analysis of ITT primary analysis using multiple imputation (MI) for any missing Day 29 (Visit 11) serum phosphate values.||||||0.976|||||||F-test|||"ITT population sensitivity analysis using multiple imputation (MI) to assess statistical analysis of linear model fit using an F-test at the 0.05 level."||||0.976
70943196|NCT02151643|141386731|OTHER|Sensitivity analysis of the primary ITT analysis using the Per Protocol (PP) population.||||||0.914|||||||F-test|||"Per protocol (PP) population sensitivity analysis to assess statistical analysis of linear model fit using an F-test at the 0.05 level."||||0.914
70943197|NCT02151643|141386731|OTHER|The primary analysis was a linear model which attempted to explain change from Baseline (Visit 7) to Day 29 (Visit 11) in serum phosphate concentration based on log-transformed dose level (assuming that placebo was equally spaced below the lowest dose level), and stratified by pre-randomisation serum phosphate level (\< 7.5 mg/dL or ≥ 7.5 mg/dL). Missing assessments were imputed using the subject's last observed phosphate concentration value (Last Observation Carried Forward \[LOCF\] imputation).|Slope|-0.329|||<|0.001|TWO_SIDED||||||linear model - log (dose) - response|||ITT population - statistical analysis of the linear model log(PT20 dose)-response relationship to examine whether the linear trend of the change in phosphate level as a function of the log-transformed dose was statistically significant.||||<0.001
70943198|NCT02151643|141386731|OTHER||||||<|0.001|||||||Mixed Models Analysis|||ITT population supportive analysis - Type 3 tests of fixed effects - treatment group||||<0.001
70943199|NCT02151643|141386731|OTHER|||||||0.436|||||||Mixed Models Analysis|||ITT population supportive analysis - Type 3 tests of fixed effects - visit||||0.436
71118557|NCT04376684|141742010|OTHER||Hazard Ratio (HR)|1.02||||0.425|TWO_SIDED|95.0|0.85|1.23||p-value is from a one-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized and age group as randomized.|||1.23|0.85|0.4250
71118558|NCT04376684|141742011|OTHER||Hazard Ratio (HR)|1.13||||0.4774|TWO_SIDED|95.0|0.81|1.59||p-value is generated from a two-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized, sex as randomized and age.|||1.59|0.81|0.4774
70871987|NCT03919799|141229336|SUPERIORITY||Least square mean difference|1.4||||0.6533|TWO_SIDED|95.0|-4.9|7.7||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||7.7|-4.9|0.6533
70871988|NCT03919799|141229336|SUPERIORITY||Least square mean difference|-1.5||||0.6338|TWO_SIDED|95.0|-8.1|5.0||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||5.0|-8.1|0.6338
70943200|NCT02151643|141386731|OTHER|||||||0.959|||||||Mixed Models Analysis|||ITT population supportive analysis - Type 3 tests of fixed effects - treatment group versus Visit interaction||||0.959
70943201|NCT02151643|141386731|OTHER||||||<|0.001|||||||Mixed Models Analysis|||ITT population supportive analysis - Type 3 tests of fixed effects - baseline serum phosphate concentration||||<0.001
70943202|NCT02151643|141386731|OTHER|||||||0.144|||||||Mixed Models Analysis|||ITT population supportive analysis - Type 3 tests of fixed effects - baseline serum phosphate concentration versus Visit interaction||||0.144
70943203|NCT02151643|141386731|OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.2847|||ONE_SIDED|97.5||0.761||||||ITT population supportive analysis - mixed model repeated measures for change in serum phosphate concentration||0.761||
70943204|NCT02151643|141386731|OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.2881|||ONE_SIDED|97.5||0.659||||||ITT population supportive analysis - mixed model repeated measures for change in serum phosphate concentration||0.659||
70943205|NCT02151643|141386731|OTHER||Mean Difference (Final Values)|-0.705|STANDARD_ERROR_OF_MEAN|0.2891|||ONE_SIDED|97.5||-0.05||||||ITT population supportive analysis - mixed model repeated measures for change in serum phosphate concentration||-0.05||
70943206|NCT02151643|141386731|OTHER||Mean Difference (Final Values)|-1.195|STANDARD_ERROR_OF_MEAN|0.255|||ONE_SIDED|97.5||-0.618||||||ITT population supportive analysis - mixed model repeated measures for change in serum phosphate concentration||-0.618||
70943207|NCT02151643|141386732|OTHER|||||||0.497|||||||ANCOVA|||Repeated measures ANCOVA for change in haemoglobin concentration from Baseline by PT20 dose group.||||0.497
70943208|NCT02151643|141386732|OTHER||||||<|0.001|||||||ANCOVA|||Repeated measures ANCOVA for change in haemoglobin concentration from Baseline by baseline hemoglobin.||||<0.001
70943209|NCT02151643|141386733|OTHER|||||||0.243|||||||ANCOVA|||Repeated measures ANCOVA for change in serum ferritin concentration from Baseline by PT20 dose group.||||0.243
70943210|NCT02151643|141386733|OTHER|||||||0.867|||||||ANCOVA|||Repeated measures ANCOVA for change in serum ferritin concentration from Baseline by Visit.||||0.867
70943211|NCT02151643|141386733|OTHER|||||||0.186|||||||ANCOVA|||Repeated measures ANCOVA for change in serum ferritin concentration from Baseline by baseline serum ferritin concentration||||0.186
70943212|NCT02151643|141386734|OTHER|||||||0.068|||||||ANCOVA|||Repeated measures ANCOVA for change in transferrin saturation from Baseline by PT20 dose group.||||0.068
70943213|NCT02151643|141386734|OTHER|||||||0.013|||||||ANCOVA|||Repeated measures ANCOVA for change in transferrin saturation from Baseline by Visit.||||0.013
70943214|NCT02151643|141386734|OTHER||||||<|0.001|||||||ANCOVA|||Repeated measures ANCOVA for change in transferrin saturation from Baseline by Baseline Transferrin Saturation.||||<0.001
70943215|NCT02151643|141386735|OTHER|||||||0.004|||||||ANCOVA|||Repeated measures ANCOVA for change in Calcium x Phosphate Product from Baseline by PT20 dose group.||||0.004
71118559|NCT04376684|141742012|OTHER||Odds Ratio (OR)|0.4||||0.0119|TWO_SIDED|95.0|0.18|0.89||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||0.89|0.18|0.0119
70943216|NCT02151643|141386735|OTHER||||||<|0.001|||||||ANCOVA|||Repeated measures ANCOVA for change in transferrin saturation from Baseline by Baseline Calcium x Phosphate Product.||||<0.001
70943217|NCT02151643|141386736|OTHER|||||||0.292|||||||paired z-test|||||||0.292
70943218|NCT02151643|141386736|OTHER|||||||0.047|||||||paired z-test|||||||0.047
70943219|NCT02151643|141386736|OTHER|||||||0.872|||||||paired z-test|||||||0.872
70943220|NCT02151643|141386736|OTHER|||||||0.288|||||||paired z-test|||||||0.288
70943221|NCT03619889|141386737|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70943222|NCT03619889|141386737|OTHER||Mean Difference (Net)|-1.2|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
70943223|NCT03619889|141386744|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70943224|NCT03619889|141386744|OTHER||Mean Difference (Net)|-0.65|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
70943225|NCT01084239|141386758|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|Result for index hospitalization||||||<0.001
71118560|NCT04376684|141742013|OTHER||Hazard Ratio (HR)|1.02||||0.4404|TWO_SIDED|95.0|0.83|1.24||p-value is from a one-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized and age group as randomized.|||1.24|0.83|0.4404
70943226|NCT02679079|141386777|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|2.1||0.89|TWO_SIDED|95.0|-4.4|3.8||Nominal p-value is considered statistically significant if less than 0.05. To control for multiplicity, comparisons were tested sequentially.|Mixed Models Analysis|||||3.8|-4.4|0.89
70943227|NCT02679079|141386777|SUPERIORITY||Mean Difference (Net)|1.5|STANDARD_ERROR_OF_MEAN|2.1||0.47|TWO_SIDED|95.0|-2.6|5.6||To control for multiplicity, comparisons were tested sequentially. Nominal p-value was not evaluated for statistical significance since first comparison was not statistically significant.|Mixed Models Analysis|||||5.6|-2.6|0.47
70943228|NCT02679079|141386778|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.21|TWO_SIDED|95.0|-1.0|0.2||To control for multiplicity, comparisons were tested sequentially. Nominal p-value was not evaluated for statistical significance since first comparison was not statistically significant.|Mixed Models Analysis|||||0.2|-1.0|0.21
70943229|NCT02679079|141386778|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.67|TWO_SIDED|95.0|-0.5|0.8||To control for multiplicity, comparisons were tested sequentially. Nominal p-value was not evaluated for statistical significance since first comparison was not statistically significant.|Mixed Models Analysis|||||0.8|-0.5|0.67
70943230|NCT02679079|141386779|SUPERIORITY||Risk Difference (RD)|13.9||||0.24|TWO_SIDED|||||Comparison was not included in multiplicity adjustment procedure.|Cochran-Mantel-Haenszel|Stratified by age group (6 to 11 years, 12 to 17 years)|Risk difference expressed as percentage.|||||0.24
70943231|NCT02679079|141386779|SUPERIORITY||Risk Difference (RD)|-4.5||||0.71|TWO_SIDED|||||Comparison was not included in multiplicity adjustment procedure.|Cochran-Mantel-Haenszel|Stratified by age group (6 to 11 years, 12 to 17 years).|Risk difference expressed as a percentage.|||||0.71
70943232|NCT02679079|141386780|SUPERIORITY||Mean Difference (Net)|-1.9|STANDARD_ERROR_OF_MEAN|2.9||0.52|TWO_SIDED|95.0|-7.7|3.9||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||3.9|-7.7|0.52
70943233|NCT02679079|141386780|SUPERIORITY||Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|2.9||0.64|TWO_SIDED|95.0|-4.5|7.2||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||7.2|-4.5|0.64
70943234|NCT02679079|141386781|SUPERIORITY||Mean Difference (Net)|-2.3|STANDARD_ERROR_OF_MEAN|4.5||0.6|TWO_SIDED|95.0|-11.2|6.5||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||6.5|-11.2|0.60
70943235|NCT02679079|141386781|SUPERIORITY||Mean Difference (Net)|2.8|STANDARD_ERROR_OF_MEAN|4.5||0.54|TWO_SIDED|95.0|-6.1|11.7||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||11.7|-6.1|0.54
70943236|NCT02679079|141386782|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|1.1||0.64|TWO_SIDED|95.0|-2.6|1.6||Comparison was not included in multiplicity adjustment procedure.|ANCOVA|||||1.6|-2.6|0.64
70943237|NCT02679079|141386782|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|1.1||0.77|TWO_SIDED|95.0|-2.5|1.9||Comparison was not included in multiplicity adjustment procedure.|ANCOVA|||||1.9|-2.5|0.77
70943238|NCT02679079|141386783|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|1.2||0.45|TWO_SIDED|95.0|-1.4|3.2||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||3.2|-1.4|0.45
70943239|NCT02679079|141386783|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|1.2||0.72|TWO_SIDED|95.0|-2.7|1.9||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||1.9|-2.7|0.72
70943240|NCT02679079|141386784|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.41|TWO_SIDED|95.0|-0.3|0.7||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||0.7|-0.3|0.41
70943241|NCT02679079|141386784|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.2||0.01|TWO_SIDED|95.0|0.2|1.1||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||1.1|0.2|0.01
70943242|NCT02679079|141386785|SUPERIORITY||Risk Difference (RD)|14.8||||0.18|TWO_SIDED|||||Comparison was not included in multiplicity adjustment procedure.|Cochran-Mantel-Haenszel|Stratified by age group (6 to 11 years, 12 to 17 years).|Risk difference expressed as a percentage.|||||0.18
70943243|NCT02679079|141386785|SUPERIORITY||Risk Difference (RD)|-0.7||||0.95|TWO_SIDED|||||Comparison was not included in multiplicity adjustment procedure.|Cochran-Mantel-Haenszel|Stratified by age group (6 to 11 years, 12 to 17 years).|Risk difference expressed as a percentage.|||||0.95
70943244|NCT04150341|141386786|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.881|TWO_SIDED|95.0|-0.14|0.12|||Mixed Models Analysis|||||0.12|-0.14|0.881
70943245|NCT04150341|141386786|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.575|TWO_SIDED|95.0|-0.17|0.1|||Mixed Models Analysis|||||0.1|-0.17|0.575
70954232|NCT00688870|141411075|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|1.5|||||TWO_SIDED|95.0|1.23|1.83|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 19A||1.83|1.23|
70943246|NCT01907113|141386858|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as mild renal function divided by normal renal function|Geometric mean ratio|118.24|STANDARD_DEVIATION|25.6|||TWO_SIDED|90.0|96.17|145.38|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||145.38|96.17|
71118561|NCT04376684|141742014|OTHER||Hazard Ratio (HR)|1.11||||0.6253|TWO_SIDED|95.0|0.72|1.72||p-value is generated from a two-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized, sex as randomized and age.|||1.72|0.72|0.6253
71118562|NCT04376684|141742015|OTHER||Hazard Ratio (HR)|1.11||||0.1078|TWO_SIDED|95.0|0.94|1.3||p-value is from a one-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized and age group as randomized.|||1.30|0.94|0.1078
71118563|NCT04376684|141742016|OTHER||Hazard Ratio (HR)|1.11||||0.114|TWO_SIDED|95.0|0.94|1.31||p-value is from a one-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized and age group as randomized.|||1.31|0.94|0.1140
71118564|NCT04376684|141742017|OTHER||Hazard Ratio (HR)|1.06||||0.7084|TWO_SIDED|95.0|0.8|1.4||p-value is generated from a two-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized, sex as randomized and age.|||1.40|0.80|0.7084
71118565|NCT04376684|141742018|OTHER||Hazard Ratio (HR)|1.13||||0.4085|TWO_SIDED|95.0|0.84|1.52||p-value is generated from a two-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized, sex as randomized and age.|||1.52|0.84|0.4085
71118566|NCT02950155|141742023|SUPERIORITY||probability ratio|2.48||||0.007|TWO_SIDED|95.0|1.2|5.11|||Fisher Exact|||The primary end-point was analyzed as an intention-to-treat analysis, with Fisher's exact test of the difference in proportion, with α=0·05 to indicate statistically significant difference||5.11|1.20|0.007
71118567|NCT02950155|141742024|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.79|TWO_SIDED|95.0|-4.4|2.1|||Wilcoxon (Mann-Whitney)|||Subjects receiving rescue treatment before evaluation being censored (per-protocol analysis)||2.1|-4.4|0.79
71118568|NCT02950155|141742025|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.34|TWO_SIDED|95.0|-3.3|0.8|||Wilcoxon (Mann-Whitney)|||Subjects receiving rescue treatment before evaluation being censored (per-protocol analysis)||0.8|-3.3|0.34
71118569|NCT02950155|141742026|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.47|TWO_SIDED|95.0|-8.2|3.8|||Wilcoxon (Mann-Whitney)|||Subjects receiving rescue treatment before evaluation being censored (per-protocol analysis)||3.8|-8.2|0.47
70854666|NCT00492063|141197839|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain B, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|6.0|||||TWO_SIDED|95.0|2.0|11.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain B in the elderly population.||11|2|
70854667|NCT00492063|141197840|NON_INFERIORITY_OR_EQUIVALENCE|The value of GMR ratio of cTIV to TIV is \>0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain A/H1N1, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|1.07|||||TWO_SIDED|95.0|0.9|1.28||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain A/H1N1 in adults.||1.28|0.9|
70871989|NCT03919799|141229337|SUPERIORITY||Least square mean difference|14.6||||0.0916|TWO_SIDED|95.0|-2.5|31.8||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||31.8|-2.5|0.0916
71118570|NCT02950155|141742027|SUPERIORITY||probability ratio|1.89||||0.036|TWO_SIDED|95.0|1.04|3.44|||Fisher Exact|||||3.44|1.04|0.036
71118571|NCT02308163|141742052|SUPERIORITY||Odds Ratio (OR)|3.13|||<|0.001|TWO_SIDED|95.0|1.76|5.58||Closed testing procedure was used for multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: ACR20-CRP response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||5.58|1.76|<0.001
71118572|NCT02308163|141742052|SUPERIORITY||Odds Ratio (OR)|6.59|||<|0.001|TWO_SIDED|95.0|3.56|12.2||Closed testing procedure was used for multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: ACR20-CRP response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||12.20|3.56|<0.001
71118573|NCT02308163|141742054|SUPERIORITY||Odds Ratio (OR)|4.79|||<|0.001|TWO_SIDED|95.0|2.14|10.75||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: ACR50-CRP response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||10.75|2.14|<0.001
71118574|NCT02308163|141742054|SUPERIORITY||Odds Ratio (OR)|7.86|||<|0.001|TWO_SIDED|95.0|3.53|17.5||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: ACR50-CRP response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||17.50|3.53|<0.001
71118575|NCT02308163|141742056|SUPERIORITY||Odds Ratio (OR)|39.93|||<|0.001|TWO_SIDED|95.0|5.29|301.61||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: ACR70-CRP response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo. Difference vs. Peficitinib 100mg was not estimable.||301.61|5.29|<0.001
70854668|NCT00492063|141197840|NON_INFERIORITY_OR_EQUIVALENCE|The value of GMR ratio of cTIV to TIV is \>0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain A/H3N2, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|0.85|||||TWO_SIDED|95.0|0.72|0.99||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain A/H3N2 in adults.||0.99|0.72|
70854669|NCT00492063|141197840|NON_INFERIORITY_OR_EQUIVALENCE|The value of GMR ratio of cTIV to TIV is \>0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain B, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|1.14|||||TWO_SIDED|95.0|0.99|1.3||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain B in adults.||1.3|0.99|
70854670|NCT00492063|141197840|NON_INFERIORITY_OR_EQUIVALENCE|The value of GMR ratio of cTIV to TIV is \>0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain A/H1N1, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|0.96|||||TWO_SIDED|95.0|0.82|1.12||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain A/H1N1 in the elderly population.||1.12|0.82|
70854671|NCT00492063|141197840|NON_INFERIORITY_OR_EQUIVALENCE|The value of GMR ratio of cTIV to TIV is \>0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain A/H3N2, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|0.87|||||TWO_SIDED|95.0|0.74|1.02||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain A/H3N2 in the elderly population.||1.02|0.74|
70854672|NCT00492063|141197840|NON_INFERIORITY_OR_EQUIVALENCE|The value of GMR ratio of cTIV to TIV is \>0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain B, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|1.27|||||TWO_SIDED|95.0|1.11|1.4||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain B in the elderly population.||1.4|1.11|
70854673|NCT01143701|141197852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.54|||<|0.05|TWO_SIDED|95.0|-5.89|-1.19|||Mixed Models Analysis|||Utilizing the full sample (n=577), an intent-to-treat analyses was conducted comparing patient outcomes across intervention and control groups using a three-level mixed model. Baseline ratings were entered as a covariate. Post-baseline ratings collected closest to 12-months post-baseline were entered as dependent variables.||-1.19|-5.89|<.05
70854674|NCT01143701|141197853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.48|||<|0.05|TWO_SIDED|95.0|-4.71|1.75|||Mixed Models Analysis|||An intent-to-treat analyses was conducted comparing patient outcomes across intervention and control groups using a three-level mixed model. Baseline ratings were entered as a covariate. Post-baseline ratings collected closest to 12-months post-baseline were entered as dependent variables.||1.75|-4.71|<0.05
70854675|NCT04157673|141197855|SUPERIORITY|||||||0.0002||||||This is the overall treatment effect from the mixed model. p-value threshold set at p = 0.05.|Mixed Models Analysis|||Statistical analysis to support visual inspection of the multiple-baseline graphs included the phase changes from baseline to Episodic future thinking treatment. Phase changes were assessed using mixed model with fixed effects of level and trend for baseline phase and random effects for level and trend for treatment phase.||||0.0002
70854676|NCT04157673|141197856|OTHER|Effect size of mean differences|Mean Difference (Final Values)|2.75|STANDARD_DEVIATION|3.78|||TWO_SIDED||||||||Cohen's d effect size = 0.73|Statistical analysis to support visual inspection of the multiple-baseline graphs included the phase changes from baseline to Episodic future thinking treatment. Phase changes were assessed using mixed model with fixed effects of level and trend for baseline phase and random effects for level and trend for treatment phase.||||
70854677|NCT04157673|141197857|OTHER|Effect size of mean pre-post differences|Mean Difference (Final Values)|0.355|STANDARD_DEVIATION|0.295|||TWO_SIDED||||||||cohen's d effect size for mean differences pre to post-treatment = 1.20|||||
71118576|NCT02308163|141742058|SUPERIORITY||LS mean|-1.06|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.41|-0.71||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: DAS28 Change = Treatment + Baseline DAS28 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-0.71|-1.41|<0.001
71118577|NCT02308163|141742058|SUPERIORITY||LS mean|-1.55|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.86|-1.24||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: DAS28 Change = Treatment + Baseline DAS28 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-1.24|-1.86|<0.001
70854678|NCT02312687|141197867|SUPERIORITY||Least Squares (LS) Mean|0.68|||<|0.0001|TWO_SIDED|95.0|0.48|0.88||The generalized estimation equation (GEE) model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|generalized estimation equation (GEE)|||Change at Week 24||0.88|0.48|< 0.0001
70854679|NCT02312687|141197867|SUPERIORITY||LS Mean|0.68|||<|0.0001|TWO_SIDED|95.0|0.57|0.79||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||0.79|0.57|< 0.0001
70854680|NCT02312687|141197867|SUPERIORITY||LS Mean|0.59|||<|0.0001|TWO_SIDED|95.0|0.44|0.75||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||0.75|0.44|< 0.0001
70871990|NCT03919799|141229337|SUPERIORITY||Least square mean difference|-8.6||||0.3146|TWO_SIDED|95.0|-25.7|8.6|||MMRM|||Belumosudil 200 mg BID versus Placebo||8.6|-25.7|0.3146
70943247|NCT01907113|141386858|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as moderate renal function divided by normal renal function|Geometric mean ratio|119.94|STANDARD_DEVIATION|25.6|||TWO_SIDED|90.0|96.25|149.47|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||149.47|96.25|
70854681|NCT02312687|141197867|SUPERIORITY||LS Mean|0.47|||<|0.0001|TWO_SIDED|95.0|0.31|0.63||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||0.63|0.31|< 0.0001
71118578|NCT02308163|141742060|SUPERIORITY||LS mean|-1.03|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.38|-0.67||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: DAS28 Change = Treatment + Baseline DAS28 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-0.67|-1.38|<0.001
71118579|NCT02308163|141742060|SUPERIORITY||LS mean|-1.64|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.96|-1.31||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: DAS28 Change = Treatment + Baseline DAS28 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-1.31|-1.96|<0.001
71118580|NCT02308163|141742062|SUPERIORITY||LS mean|-4.6|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-6.8|-2.4||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: TJC68 Change = Treatment + Baseline TJC68 + the prior biologic - DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-2.4|-6.8|<0.001
71118581|NCT02308163|141742062|SUPERIORITY||LS mean|-6.1|STANDARD_ERROR_OF_MEAN|1.0|<|0.001|TWO_SIDED|95.0|-8.1|-4.0||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: TJC68 Change = Treatment + Baseline TJC68 + the prior biologic - DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-4.0|-8.1|<0.001
71118582|NCT02308163|141742064|SUPERIORITY||LS mean|-3.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|-4.6|-1.4||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: TJC68 Change = Treatment + Baseline TJC68 + the prior biologic - DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-1.4|-4.6|<0.001
71118583|NCT02308163|141742064|SUPERIORITY||LS mean|-5.3|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-6.8|-3.9||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: TJC68 Change = Treatment + Baseline TJC68 + the prior biologic - DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-3.9|-6.8|<0.001
71118584|NCT02308163|141742066|SUPERIORITY||Odds Ratio (OR)|6.4|||<|0.001|TWO_SIDED|95.0|2.31|17.67||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-CRP score \< 2.6 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||17.67|2.31|<0.001
71118585|NCT02308163|141742066|SUPERIORITY||Odds Ratio (OR)|10.13|||<|0.001|TWO_SIDED|95.0|3.76|27.27||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-CRP score \< 2.6 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||27.27|3.76|<0.001
71118586|NCT02308163|141742068|SUPERIORITY||Odds Ratio (OR)|21.72||||0.003|TWO_SIDED|95.0|2.83|166.66||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-ESR score \< 2.6 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo. Difference vs. Peficitinib 100mg was not estimable.||166.66|2.83|0.003
71118587|NCT02308163|141742070|SUPERIORITY||Odds Ratio (OR)|5.8|||<|0.001|TWO_SIDED|95.0|2.74|12.29||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-CRP score ≤ 3.2 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||12.29|2.74|<0.001
71118588|NCT02308163|141742070|SUPERIORITY||Odds Ratio (OR)|9.66|||<|0.001|TWO_SIDED|95.0|4.57|20.41||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-CRP score ≤ 3.2 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||20.41|4.57|<0.001
71118589|NCT02308163|141742072|SUPERIORITY||Odds Ratio (OR)|3.24||||0.012|TWO_SIDED|95.0|1.29|8.12||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-ESR score ≤ 3.2 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||8.12|1.29|0.012
71118590|NCT02308163|141742072|SUPERIORITY||Odds Ratio (OR)|8.19|||<|0.001|TWO_SIDED|96.0|3.42|19.63||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-ESR score ≤ 3.2 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||19.63|3.42|<0.001
70854682|NCT02312687|141197867|SUPERIORITY||LS Mean|0.57|||<|0.0001|TWO_SIDED|95.0|0.41|0.73||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||0.73|0.41|< 0.0001
70854683|NCT02312687|141197867|SUPERIORITY||LS Mean|0.59|||<|0.0001|TWO_SIDED|95.0|0.43|0.76||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||0.76|0.43|< 0.0001
70854684|NCT02312687|141197868|SUPERIORITY||LS Mean|-9.75||||0.1366|TWO_SIDED|95.0|-22.59|3.09||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 24||3.09|-22.59|0.1366
70854685|NCT02312687|141197868|SUPERIORITY||LS Mean|-11.17||||0.1334|TWO_SIDED|95.0|-25.76|3.42||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 48||3.42|-25.76|0.1334
70854686|NCT02312687|141197868|SUPERIORITY||LS Mean|-18.12|||<|0.0001|TWO_SIDED|95.0|-27.07|-9.17||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 72||-9.17|-27.07|< 0.0001
70854687|NCT02312687|141197868|SUPERIORITY||LS Mean|-25.28|||<|0.0001|TWO_SIDED|95.0|-36.21|-14.35||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 96||-14.35|-36.21|< 0.0001
70854688|NCT02312687|141197868|SUPERIORITY||LS Mean|-22.39|||<|0.0001|TWO_SIDED|95.0|-31.51|-13.26||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 120||-13.26|-31.51|< 0.0001
70854689|NCT02312687|141197868|SUPERIORITY||LS Mean|-28.33|||<|0.0001|TWO_SIDED|95.0|-40.11|-16.56||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 144||-16.56|-40.11|< 0.0001
70854690|NCT02312687|141197869|SUPERIORITY||LS Mean|215493.38|||<|0.0001|TWO_SIDED|95.0|194650.78|236335.97||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||236335.97|194650.78|< 0.0001
71118591|NCT02308163|141742074|SUPERIORITY||LS Mean|-1.112|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|-1.546|-0.679||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test|Covariance model||Based on analysis of covariance model: CRP Change = Treatment + Baseline CRP + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-0.679|-1.546|<0.001
71118592|NCT02308163|141742074|SUPERIORITY||LS mean|-1.677|STANDARD_ERROR_OF_MEAN|0.221|<|0.001|TWO_SIDED|95.0|-2.114|-1.241||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: CRP Change = Treatment + Baseline CRP + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-1.241|-2.114|<0.001
70854691|NCT02312687|141197869|SUPERIORITY||LS Mean|202525.38|||<|0.0001|TWO_SIDED|95.0|168364.92|236685.83||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||236685.83|168364.92|< 0.0001
70854692|NCT02312687|141197869|SUPERIORITY||LS Mean|221481.03|||<|0.0001|TWO_SIDED|95.0|179628.07|263333.98||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||263333.98|179628.07|< 0.0001
70854693|NCT02312687|141197869|SUPERIORITY||LS Mean|221674.07|||<|0.0001|TWO_SIDED|95.0|181313.34|262034.81||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||262034.81|181313.34|< 0.0001
70854694|NCT02312687|141197869|SUPERIORITY||LS Mean|208270.02|||<|0.0001|TWO_SIDED|95.0|167217.98|249322.06||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||249322.06|167217.98|< 0.0001
70854695|NCT02312687|141197869|SUPERIORITY||LS Mean|235953.55|||<|0.0001|TWO_SIDED|95.0|166110.59|305796.52||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||305796.52|166110.59|< 0.0001
70854696|NCT02312687|141197870|SUPERIORITY||LS Mean|1277.84|||<|0.0001|TWO_SIDED|95.0|1202.34|1353.34||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||1353.34|1202.34|< 0.0001
70854697|NCT02312687|141197870|SUPERIORITY||LS Mean|1244.99|||<|0.0001|TWO_SIDED|95.0|1166.1|1323.88||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||1323.88|1166.10|< 0.0001
70871991|NCT03919799|141229338|SUPERIORITY||Least square mean difference|-10.0||||0.3753|TWO_SIDED|95.0|-32.8|12.8||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||12.8|-32.8|0.3753
71118593|NCT02308163|141742076|SUPERIORITY||LS mean|-10.9|STANDARD_ERROR_OF_MEAN|2.56|<|0.001|TWO_SIDED|95.0|-15.95|-5.84||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: ESR Change = Treatment + Baseline ESR + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-5.84|-15.95|<0.001
70943248|NCT01907113|141386858|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as severe renal function divided by normal renal function|Geometric mean ratio|166.29|STANDARD_DEVIATION|25.6|||TWO_SIDED|90.0|134.44|205.68|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||205.68|134.44|
70854698|NCT02312687|141197870|SUPERIORITY||LS Mean|1298.49|||<|0.0001|TWO_SIDED|95.0|1233.56|1363.43||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||1363.43|1233.56|< 0.0001
70854699|NCT02312687|141197870|SUPERIORITY||LS Mean|1311.05|||<|0.0001|TWO_SIDED|95.0|1238.3|1383.8||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||1383.80|1238.30|< 0.0001
70854700|NCT02312687|141197870|SUPERIORITY||LS Mean|1368.68|||<|0.0001|TWO_SIDED|95.0|1327.4|1409.96||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||1409.96|1327.40|< 0.0001
70943249|NCT01907113|141386858|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as kidney failure divided by normal renal function|Geometric mean ratio|148.29|STANDARD_DEVIATION|25.6|||TWO_SIDED|90.0|119.89|183.42|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||183.42|119.89|
71118594|NCT02308163|141742076|SUPERIORITY||LS mean|-21.14|STANDARD_ERROR_OF_MEAN|2.47|<|0.001|TWO_SIDED|95.0|-26.01|-16.27||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: ESR Change = Treatment + Baseline ESR + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-16.27|-26.01|<0.001
71118595|NCT02308163|141742078|SUPERIORITY||Odds Ratio (OR)|6.64|||<|0.001|TWO_SIDED|95.0|2.98|14.83||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||14.83|2.98|<0.001
71118596|NCT02308163|141742078|SUPERIORITY||Odds Ratio (OR)|10.86|||<|0.001|TWO_SIDED|95.0|4.91|24.03||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||24.03|4.91|<0.001
71118597|NCT02308163|141742080|SUPERIORITY||Odds Ratio (OR)|4.37|||<|0.001|TWO_SIDED|95.0|2.38|8.04||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good or Moderate Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||8.04|2.38|<0.001
71118598|NCT02308163|141742080|SUPERIORITY||Odds Ratio (OR)|16.78|||<|0.001|TWO_SIDED|95.0|7.31|38.51||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good or Moderate Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||38.51|7.31|<0.001
71118599|NCT02308163|141742082|SUPERIORITY||Odds Ratio (OR)|4.29||||0.006|TWO_SIDED|95.0|1.52|12.08||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||12.08|1.52|0.006
71118600|NCT02308163|141742082|SUPERIORITY||Odds Ratio, log|11.01|||<|0.001|TWO_SIDED|95.0|4.07|29.74||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||29.74|4.07|<0.001
71118601|NCT02308163|141742084|SUPERIORITY||Odds Ratio (OR)|3.82|||<|0.001||95.0|2.11|6.93||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good or Moderate Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||6.93|2.11|<0.001
71118602|NCT02308163|141742084|SUPERIORITY||Odds Ratio (OR)|13.65|||<|0.001|TWO_SIDED|95.0|6.39|29.17||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good or Moderate Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||29.17|6.39|<0.001
71118603|NCT02308163|141742090|SUPERIORITY||LS Mean|-9.94|STANDARD_ERROR_OF_MEAN|1.89|<|0.001|TWO_SIDED|95.0|-13.66|-6.22||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SDAI Change = Treatment + Baseline SDAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-6.22|-13.66|<0.001
71118604|NCT02308163|141742090|SUPERIORITY||Odds Ratio (OR)|-14.43|STANDARD_ERROR_OF_MEAN|1.66|<|0.001|TWO_SIDED|95.0|-17.71|-11.15||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SDAI Change = Treatment + Baseline SDAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-11.15|-17.71|<0.001
71118605|NCT02308163|141742094|SUPERIORITY||LS mean|-8.69|STANDARD_ERROR_OF_MEAN|1.77|<|0.001|TWO_SIDED|95.0|-12.19|-5.2||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|ANCOVA||Based on ANCOVA Model: CDAI Change = Treatment + Baseline CDAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-5.20|-12.19|<0.001
71118606|NCT02308163|141742094|SUPERIORITY||LS mean|-12.83|STANDARD_ERROR_OF_MEAN|1.58|<|0.001|TWO_SIDED|95.0|-15.96|-9.71||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|ANCOVA||Based on ANCOVA Model: CDAI Change = Treatment + Baseline CDAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-9.71|-15.96|<0.001
71118607|NCT02308163|141742096|SUPERIORITY||LS mean|-15.2|STANDARD_ERROR_OF_MEAN|3.14|<|0.001|TWO_SIDED|95.0|-21.4|-9.0||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: PGA (100 mm VAS) Change = Treatment + Baseline PGA (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-9.00|-21.40|<0.001
70854701|NCT02312687|141197870|SUPERIORITY||LS Mean|1298.41|||<|0.0001|TWO_SIDED|95.0|1208.31|1388.51||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||1388.51|1208.31|< 0.0001
70854702|NCT02312687|141197871|SUPERIORITY||LS Mean|7.87||||0.0011|TWO_SIDED|95.0|3.16|12.58||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||12.58|3.16|0.0011
70854703|NCT02312687|141197871|SUPERIORITY||LS Mean|2.7||||0.3092|TWO_SIDED|95.0|-2.5|7.9||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||7.90|-2.50|0.3092
70854704|NCT02312687|141197871|SUPERIORITY||LS Mean|2.62||||0.2958|TWO_SIDED|95.0|-2.29|7.53||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||7.53|-2.29|0.2958
70854705|NCT02312687|141197871|SUPERIORITY||LS Mean|0.31||||0.8796|TWO_SIDED|95.0|-3.71|4.33||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||4.33|-3.71|0.8796
70854706|NCT02312687|141197871|SUPERIORITY||LS Mean|-0.48||||0.8396|TWO_SIDED|95.0|-5.11|4.16||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||4.16|-5.11|0.8396
70871992|NCT03919799|141229338|SUPERIORITY||Least square mean difference|-0.7||||0.9481|TWO_SIDED|95.0|-23.5|22.1||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||22.1|-23.5|0.9481
70854707|NCT02312687|141197871|SUPERIORITY||LS Mean|-3.43||||0.2284|TWO_SIDED|95.0|-9.0|2.15||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||2.15|-9.00|0.2284
70854708|NCT02312687|141197872|SUPERIORITY||LS Mean|0.57|||||TWO_SIDED|95.0|0.32|0.83||||||Change at Week 24||0.83|0.32|
70854709|NCT02312687|141197872|SUPERIORITY||LS Mean|0.47|||||TWO_SIDED|95.0|0.37|0.56||||||Change at Week 48||0.56|0.37|
70854710|NCT02312687|141197872|SUPERIORITY||LS Mean|0.42|||||TWO_SIDED|95.0|0.28|0.56||||||Change at Week 72||0.56|0.28|
70854711|NCT02312687|141197872|SUPERIORITY||LS Mean|0.44|||||TWO_SIDED|95.0|0.27|0.6||||||Change at Week 96||0.60|0.27|
70943250|NCT01907113|141386859|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as mild renal function divided by normal renal function|Geometric mean ratio|118.83|STANDARD_DEVIATION|29.7|||TWO_SIDED|90.0|93.62|150.84|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||150.84|93.62|
70943251|NCT01907113|141386859|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as moderate renal function divided by normal renal function|Geometric mean ratio|102.27|STANDARD_DEVIATION|29.7|||TWO_SIDED|90.0|79.33|131.85|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||131.85|79.33|
70954233|NCT00688870|141411076|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMC|0.64|||||TWO_SIDED|95.0|0.49|0.84|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 4||0.84|0.49|
71118608|NCT02308163|141742096|SUPERIORITY||LS mean|-23.14|STANDARD_ERROR_OF_MEAN|2.86|<|0.001|TWO_SIDED|95.0|-28.78|-17.51||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: PGA (100 mm VAS) Change = Treatment + Baseline PGA (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-17.51|-28.78|<0.001
71118609|NCT02308163|141742098|SUPERIORITY||LS mean|-16.88|STANDARD_ERROR_OF_MEAN|3.51|<|0.001|TWO_SIDED|95.0|-23.81|-9.95||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SGA (100 mm VAS) Change = Treatment + Baseline SGA (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-9.95|-23.81|<0.001
71118610|NCT02308163|141742098|SUPERIORITY||LS mean|-23.56|STANDARD_ERROR_OF_MEAN|3.18|<|0.001|TWO_SIDED|95.0|-29.83|-17.28||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SGA (100 mm VAS) Change = Treatment + Baseline SGA (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-17.28|-29.83|<0.001
71118611|NCT02308163|141742100|SUPERIORITY||LS mean|-17.58|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-24.36|-10.81||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SGA of pain (100 mm VAS) Change = Treatment + Baseline SGA of pain (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-10.81|-24.36|<0.001
71118612|NCT02308163|141742100|SUPERIORITY||LS mean|-23.9|STANDARD_ERROR_OF_MEAN|3.21|<|0.001|TWO_SIDED|95.0|-30.24|-17.57||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SGA of pain (100 mm VAS) Change = Treatment + Baseline SGA of pain (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-17.57|-30.24|<0.001
71118613|NCT02308163|141742102|SUPERIORITY|||||||0.033||||||No Multiplicity Adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Fisher Exact|||Treatment Difference vs Placebo||||0.033
71118614|NCT02308163|141742102|SUPERIORITY|||||||0.035||||||No Multiplicity Adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Fisher Exact|||Treatment Difference vs Placebo||||0.035
71118615|NCT02308163|141742103|SUPERIORITY||LS mean|-0.34|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.48|-0.2||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: HAQ-DI Change = Treatment + Baseline HAQ-DI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea., and Taiwan)|Treatment Difference vs Placebo||-0.20|-0.48|<0.001
71118616|NCT02308163|141742103|SUPERIORITY||LS mean|-0.4|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.53|-0.26||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: HAQ-DI Change = Treatment + Baseline HAQ-DI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea., and Taiwan)|Treatment Difference vs Placebo||-0.26|-0.53|<0.001
70943252|NCT01907113|141386859|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as severe renal function divided by normal renal function|Geometric mean ratio|120.68|STANDARD_DEVIATION|29.7|||TWO_SIDED|90.0|94.42|154.25|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||154.25|94.42|
70943253|NCT01907113|141386859|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as kidney failure divided by normal renal function|Geometric mean ratio|103.75|STANDARD_DEVIATION|29.7|||TWO_SIDED|95.0|81.18|132.61|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||132.61|81.18|
71118617|NCT02308163|141742105|SUPERIORITY||LS mean|6.87|STANDARD_ERROR_OF_MEAN|1.61|<|0.001|TWO_SIDED|95.0|3.69|10.05||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||10.05|3.69|<0.001
71118618|NCT02308163|141742105|SUPERIORITY||LS mean|6.98|STANDARD_ERROR_OF_MEAN|1.45|<|0.001|TWO_SIDED|95.0|4.11|9.85||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||9.85|4.11|<0.001
71118619|NCT02308163|141742107|SUPERIORITY||LS mean|2.89|STANDARD_ERROR_OF_MEAN|1.0||0.004|TWO_SIDED|95.0|0.91|4.87||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||4.87|0.91|0.004
71118620|NCT02308163|141742107|SUPERIORITY||LS mean|3.25|STANDARD_ERROR_OF_MEAN|0.98||0.001|TWO_SIDED|95.0|1.3|5.19||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||5.19|1.30|0.001
71118621|NCT02308163|141742109|SUPERIORITY||LS mean|2.27|STANDARD_ERROR_OF_MEAN|1.8||0.21|TWO_SIDED|95.0|-1.29|5.83||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||5.83|-1.29|0.210
71118622|NCT02308163|141742109|SUPERIORITY||LS mean|6.23|STANDARD_ERROR_OF_MEAN|1.77|<|0.001|TWO_SIDED|95.0|2.74|9.71||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||9.71|2.74|<0.001
71118623|NCT02308163|141742111|SUPERIORITY||LS mean|-8.55|STANDARD_ERROR_OF_MEAN|3.81||0.027|TWO_SIDED|95.0|-16.11|-1.0||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-1.00|-16.11|0.027
71118624|NCT02308163|141742111|SUPERIORITY||LS mean|-10.17|STANDARD_ERROR_OF_MEAN|3.88||0.01|TWO_SIDED|95.0|-17.88|-2.47||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-2.47|-17.88|0.010
71118625|NCT02308163|141742113|SUPERIORITY||LS mean|-20.67|STANDARD_ERROR_OF_MEAN|4.92|<|0.001|TWO_SIDED|95.0|-30.44|-10.89||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-10.89|-30.44|<0.001
71118626|NCT02308163|141742113|SUPERIORITY||LS mean|-22.01|STANDARD_ERROR_OF_MEAN|5.06|<|0.001|TWO_SIDED|95.0|-32.06|-11.97||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-11.97|-32.06|<0.001
71118627|NCT02308163|141742115|SUPERIORITY||LS mean|-20.22|STANDARD_ERROR_OF_MEAN|5.12|<|0.001|TWO_SIDED|95.0|-30.38|-10.06||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-10.06|-30.38|<0.001
71118628|NCT02308163|141742115|SUPERIORITY||LS mean|-23.67|STANDARD_ERROR_OF_MEAN|5.28|<|0.001|TWO_SIDED|95.0|-34.16|-13.17|||Covariance model|No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-13.17|-34.16|<0.001
71118629|NCT02308163|141742117|SUPERIORITY||LS mean|-17.3|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-24.0|-10.61||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-10.61|-24.00|<0.001
71118630|NCT02308163|141742117|SUPERIORITY||LS mean|-20.41|STANDARD_ERROR_OF_MEAN|3.13|<|0.001|TWO_SIDED|95.0|-26.59|-14.24||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-14.24|-26.59|<0.001
71118631|NCT02136680|141742171|SUPERIORITY||Regression Coefficient|0.046||||0.4|TWO_SIDED||||||Regression, Linear|||Change in Self-Esteem from Baseline to First Follow-up: Intervention Group vs. Control Group||||0.400
70854712|NCT02312687|141197872|SUPERIORITY||LS Mean|0.36|||||TWO_SIDED|95.0|0.23|0.48||||||Change at Week 120||0.48|0.23|
70854713|NCT02312687|141197872|SUPERIORITY||LS Mean|0.47|||||TWO_SIDED|95.0|0.32|0.62||||||Change at Week 144||0.62|0.32|
70854714|NCT02312687|141197873|SUPERIORITY||LS Mean|0.04|||||TWO_SIDED|95.0|0.01|0.07||||||Change at Week 24||0.07|0.01|
70854715|NCT02312687|141197873|SUPERIORITY||LS Mean|0.01|||||TWO_SIDED|95.0|-0.01|0.03||||||Change at Week 48||0.03|-0.01|
70854716|NCT02312687|141197873|SUPERIORITY||LS Mean|0.01|||||TWO_SIDED|95.0|-0.01|0.04||||||Change at Week 72||0.04|-0.01|
70854717|NCT02312687|141197873|SUPERIORITY||LS Mean|0.05|||||TWO_SIDED|95.0|0.02|0.07||||||Change at Week 96||0.07|0.02|
70854718|NCT02312687|141197873|SUPERIORITY||LS Mean|0.01|||||TWO_SIDED|95.0|-0.02|0.03||||||Change at Week 120||0.03|-0.02|
70854719|NCT02312687|141197873|SUPERIORITY||LS Mean|0.02|||||TWO_SIDED|95.0|-0.01|0.05||||||Change at Week 144||0.05|-0.01|
70854720|NCT02312687|141197874|SUPERIORITY||LS Mean|-0.04|||||TWO_SIDED|95.0|-0.07|-0.01||||||Change at Week 24||-0.01|-0.07|
70854721|NCT02312687|141197874|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.03|0.01||||||Change at Week 48||0.01|-0.03|
70854722|NCT02312687|141197874|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.04|0.01||||||Change at Week 72||0.01|-0.04|
70854723|NCT02312687|141197874|SUPERIORITY||LS Mean|-0.05|||||TWO_SIDED|95.0|-0.07|-0.02||||||Change at Week 96||-0.02|-0.07|
70854724|NCT02312687|141197874|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.03|0.02||||||Change at Week 120||0.02|-0.03|
70854725|NCT02312687|141197874|SUPERIORITY||LS Mean|-0.02|||||TWO_SIDED|95.0|-0.05|0.01||||||Change at Week 144||0.01|-0.05|
70854726|NCT02312687|141197875|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.1|0.08||||||Change at Week 24||0.08|-0.10|
70854727|NCT02312687|141197875|SUPERIORITY||LS Mean|0.02|||||TWO_SIDED|95.0|-0.07|0.1||||||Change at Week 48||0.10|-0.07|
70854728|NCT02312687|141197875|SUPERIORITY||LS Mean|0.08|||||TWO_SIDED|95.0|-0.01|0.16||||||Change at Week 72||0.16|-0.01|
70854729|NCT02312687|141197875|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.09|0.06||||||Change at Week 96||0.06|-0.09|
70854730|NCT02312687|141197875|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.12|0.1||||||Change at Week 120||0.10|-0.12|
70854731|NCT02312687|141197875|SUPERIORITY||LS Mean|-0.05|||||TWO_SIDED|95.0|-0.16|0.06||||||Change at Week 144||0.06|-0.16|
70854732|NCT02312687|141197876|SUPERIORITY||LS Mean|22.89|||||TWO_SIDED|95.0|-1.81|47.6||||||Change at Week 24||47.60|-1.81|
70854733|NCT02312687|141197876|SUPERIORITY||LS Mean|15.15|||||TWO_SIDED|95.0|-2.32|32.62||||||Change at Week 48||32.62|-2.32|
70854734|NCT02312687|141197876|SUPERIORITY||LS Mean|11.1|||||TWO_SIDED|95.0|-14.33|36.53||||||Change at Week 72||36.53|-14.33|
70854735|NCT02312687|141197876|SUPERIORITY||LS Mean|-16.65|||||TWO_SIDED|95.0|-37.5|4.2||||||Change at Week 96||4.20|-37.50|
70854736|NCT02312687|141197876|SUPERIORITY||LS Mean|3.48|||||TWO_SIDED|95.0|-32.53|39.49||||||Change at Week 120||39.49|-32.53|
70854737|NCT02312687|141197876|SUPERIORITY||LS Mean|28.55|||||TWO_SIDED|95.0|-11.12|68.22||||||Change at Week 144||68.22|-11.12|
70854738|NCT02312687|141197877|SUPERIORITY||LS Mean|-14.77|||||TWO_SIDED|95.0|-87.62|58.08||||||Change at Week 24||58.08|-87.62|
70854739|NCT02312687|141197877|SUPERIORITY||LS Mean|-70.79|||||TWO_SIDED|95.0|-161.31|19.74||||||Change at Week 48||19.74|-161.31|
70854740|NCT02312687|141197877|SUPERIORITY||LS Mean|-16.11|||||TWO_SIDED|95.0|-110.96|78.73||||||Change at Week 72||78.73|-110.96|
70854741|NCT02312687|141197877|SUPERIORITY||LS Mean|-41.74|||||TWO_SIDED|95.0|-150.61|67.13||||||Change at Week 96||67.13|-150.61|
70854742|NCT02312687|141197877|SUPERIORITY||LS Mean|-76.11|||||TWO_SIDED|95.0|-237.29|85.08||||||Change at Week 120||85.08|-237.29|
70854743|NCT02312687|141197877|SUPERIORITY||LS Mean|-96.06|||||TWO_SIDED|95.0|-206.59|14.46||||||Change at Week 144||14.46|-206.59|
70854744|NCT02312687|141197878|SUPERIORITY||LS Mean|0.01|||||TWO_SIDED|95.0|-0.01|0.03||||||Change at Week 24||0.03|-0.01|
70854745|NCT02312687|141197878|SUPERIORITY||LS Mean|0.01|||||TWO_SIDED|95.0|-0.01|0.04||||||Change at Week 48||0.04|-0.01|
70854746|NCT02312687|141197878|SUPERIORITY||LS Mean|0.0|||||TWO_SIDED|95.0|-0.02|0.02||||||Change at Week 72||0.02|-0.02|
70854747|NCT02312687|141197878|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.04|0.02||||||Change at Week 96||0.02|-0.04|
70854748|NCT02312687|141197878|SUPERIORITY||LS Mean|0.0|||||TWO_SIDED|95.0|-0.02|0.03||||||Change at Week 120||0.03|-0.02|
70854749|NCT02312687|141197878|SUPERIORITY||LS Mean|0.03|||||TWO_SIDED|95.0|-0.01|0.08||||||Change at Week 144||0.08|-0.01|
70854750|NCT02312687|141197879|SUPERIORITY||LS Mean|14.92||||0.0314|TWO_SIDED|95.0|1.33|28.52||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||28.52|1.33|0.0314
70854751|NCT02312687|141197879|SUPERIORITY||LS Mean|-1.73||||0.764|TWO_SIDED|95.0|-13.0|9.55||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||9.55|-13.00|0.7640
70854752|NCT02312687|141197879|SUPERIORITY||LS Mean|-22.28|||<|0.0001|TWO_SIDED|95.0|-30.2|-14.35||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||-14.35|-30.20|< 0.0001
70854753|NCT02312687|141197879|SUPERIORITY||LS Mean|-20.93|||<|0.0001|TWO_SIDED|95.0|-27.92|-13.94||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||-13.94|-27.92|< 0.0001
70854754|NCT02312687|141197879|SUPERIORITY||LS Mean|-18.77||||0.0094|TWO_SIDED|95.0|-32.93|-4.6||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||-4.60|-32.93|0.0094
70854755|NCT02312687|141197879|SUPERIORITY||LS Mean|-25.72|||<|0.0001|TWO_SIDED|95.0|-36.89|-14.54||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||-14.54|-36.89|< 0.0001
70854756|NCT02312687|141197880|SUPERIORITY||LS Mean|4.68||||0.1673|TWO_SIDED|95.0|-1.96|11.32||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||11.32|-1.96|0.1673
70871993|NCT03919799|141229339|SUPERIORITY||Least square mean difference|-0.036||||0.8387|TWO_SIDED|95.0|-0.392|0.32||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||0.320|-0.392|0.8387
70943254|NCT00833898|141386874|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|||||||0.020
70943255|NCT00833898|141386875|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Mixed Models Analysis|||||||0.15
70943256|NCT00833898|141386876|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Mixed Models Analysis|||||||0.029
70943257|NCT00833898|141386877|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Mixed Models Analysis|||||||0.003
70943258|NCT00833898|141386878|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Mixed Models Analysis|||||||0.012
70943259|NCT00833898|141386879|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||Mixed Models Analysis|||||||0.40
70943260|NCT00833898|141386880|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||Mixed Models Analysis|||||||0.44
70943261|NCT00833898|141386881|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Mixed Models Analysis|||||||0.75
70943262|NCT00833898|141386882|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||Mixed Models Analysis|||||||0.17
70943263|NCT00833898|141386883|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Mixed Models Analysis|||||||0.97
70854757|NCT02312687|141197880|SUPERIORITY||LS Mean|-2.68||||0.233|TWO_SIDED|95.0|-7.09|1.72||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||1.72|-7.09|0.2330
70943264|NCT00833898|141386884|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||Mixed Models Analysis|||||||0.55
70943265|NCT00833898|141386885|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Mixed Models Analysis|||||||0.30
70943266|NCT00833898|141386886|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Mixed Models Analysis|||||||0.67
70943267|NCT00833898|141386887|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||Mixed Models Analysis|||||||0.013
70943268|NCT00833898|141386888|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||0.80
70943269|NCT00833898|141386889|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Mixed Models Analysis|||||||0.26
70943270|NCT00833898|141386890|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.58
70943271|NCT00833898|141386890|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.33
70854758|NCT02312687|141197880|SUPERIORITY||LS Mean|-7.45|||<|0.0001|TWO_SIDED|95.0|-9.54|-5.36||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||-5.36|-9.54|< 0.0001
70943272|NCT00833898|141386891|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||Mixed Models Analysis|||||||0.53
70943273|NCT00833898|141386892|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.18
70943274|NCT00833898|141386892|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||1.00
70943275|NCT00833898|141386893|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.43
70943276|NCT00833898|141386893|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.72
70943277|NCT00833898|141386894|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.43
70943278|NCT00833898|141386894|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.72
70943279|NCT01057888|141386906|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3|||<|0.05|TWO_SIDED|95.0|1.0|1.7|||Regression, Cox|It is a robust, clustered stratified Cox regression model|The control group serves as the denominator. The telephone reminder group serves as the numerator.|The null hypothesis is that there is no difference in total immunization status between the control group and the group receiving telephone (autodialer) reminders. This was analyzed using a clustered, stratified Cox model.||1.7|1.0|<0.05
70943280|NCT01057888|141386906|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6|||<|0.01|TWO_SIDED|95.0|1.3|2.1|||Regression, Cox|We used a robust, clustered, stratified Cox regression model.|The control group represents the denominator. The letter reminder group represents the numerator.|||2.1|1.3|<0.01
70943281|NCT01057888|141386906|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.075|TWO_SIDED|95.0|1.0|1.6|||Regression, Cox||The mail reminder arm represents the numerator and the telephone reminder arm represents the denominator.|The null hypothesis was that there is no difference in the percentage of fully vaccinated adolescents between the mailed reminder versus the telephone reminder arms||1.6|1.0|0.075
70943282|NCT01057888|141386907|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2|||<|0.01|TWO_SIDED|95.0|1.1|1.3|||Regression, Cox||The control group represents the denominator and the mailed reminder group represents the numerator.|The null hypothesis was that a difference in well child care rates among adolescents whose families received a mailed reminder compared to the control group||1.3|1.1|<0.01
70943283|NCT01057888|141386907|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||<|0.05|TWO_SIDED|95.0|1.0|1.3|||Regression, Cox||The control group represents the denominator and the telephone reminder group represents the numerator|The null hypothesis is the the well child care rates of adolescents in the telephone reminder group would not differ from those of the control group||1.3|1.0|<0.05
71118632|NCT02136680|141742171|SUPERIORITY||Regression Coefficient|0.119||||0.022|TWO_SIDED||||||Regression, Linear|||Change in Self-Esteem from Baseline to Second Follow-up: Intervention Group vs. Control Group||||0.022
71118633|NCT02136680|141742171|SUPERIORITY||Regression Coefficient|-0.003||||0.347|TWO_SIDED||||||Regression, Linear|||Change in Self-Esteem from First Follow-up to Second Follow-up: Intervention Group vs. Control Group||||0.347
71118634|NCT02136680|141742172|SUPERIORITY||Regression Coefficient|-0.003||||0.959|TWO_SIDED||||||Regression, Linear|||Change in Global QOL from Baseline to First Follow-up: Intervention Group vs. Control Group||||0.959
71118635|NCT02136680|141742172|SUPERIORITY||Regression Coefficient|0.143||||0.021|TWO_SIDED||||||Regression, Linear|||Change in Global QOL from Baseline to Second Follow-up: Intervention Group vs. Control Group||||0.021
71118636|NCT02136680|141742172|SUPERIORITY||Regression Coefficient|0.048||||0.454|TWO_SIDED||||||Regression, Linear|||Change in Global QOL from First Follow-up to Second Follow-up: Intervention Group vs. Control Group||||0.454
71118637|NCT02136680|141742172|SUPERIORITY||Regression Coefficient|-0.015||||0.774|TWO_SIDED||||||Regression, Linear|||Change in Summary QOL from Baseline to First Follow-up||||0.774
71118638|NCT02136680|141742172|SUPERIORITY||Regression Coefficient|0.137||||0.018|TWO_SIDED||||||Regression, Linear|||Change in Summary QOL from Baseline to Second Follow-up: Intervention Group vs. Control Group||||0.018
71118639|NCT02136680|141742172|SUPERIORITY||Regression Coefficient|0.051||||0.362|TWO_SIDED||||||Regression, Linear|||Change in Summary QOL from First Follow-up to Second Follow-up: Intervention Group vs. Control Group||||0.362
71118640|NCT02136680|141742173|SUPERIORITY||Regression Coefficient|-0.072||||0.213|TWO_SIDED||||||Regression, Linear|||Change in Palliative Outcomes from Baseline to First Follow-up: Intervention Group vs. Control Group||||0.213
71118641|NCT02136680|141742173|SUPERIORITY||Regression Coefficient|0.037||||0.561|TWO_SIDED||||||Regression, Linear|||Change in Palliative Outcomes from Baseline to Second Follow-up: Intervention Group vs. Control Group||||0.561
71118642|NCT02136680|141742173|SUPERIORITY|Change in Palliative Outcomes from First Follow-up to Second Follow-up: Intervention Group vs. Control Group|Regression Coefficient|0.165||||0.008|TWO_SIDED||||||Regression, Linear|||||||0.008
71118643|NCT05151445|141742180|OTHER||95% CI|-3.56||||0.002|TWO_SIDED|95.0|-5.65|-1.46|||McNemar|||Week 4 vs. Baseline||-1.46|-5.65|0.002
71118644|NCT05151445|141742180|OTHER||95% CI|-3.11||||0.004|TWO_SIDED|95.0|-5.07|-1.15|||McNemar|||Week 8 vs. Baseline||-1.15|-5.07|0.004
71118645|NCT05151445|141742180|OTHER||95% CI|-2.53||||0.038|TWO_SIDED|95.0|-4.9|0.16|||McNemar|||Week 12 vs. Baseline||0.16|-4.90|0.038
70943284|NCT01057888|141386907|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.234|TWO_SIDED|95.0|1.0|1.2|||Regression, Cox||The mail reminder arm represents the numerator and the telephone reminder arm represents the denominator|The null hypothesis was that there would be no difference in the well child care rate among adolescents in the mailed reminder arm versus adolescents in the telephone reminder arm of the intervention||1.2|1.0|0.234
71118646|NCT05151445|141742181|OTHER||95% CI|9.61||||0.062|TWO_SIDED|95.0|-0.55|19.77|||McNemar|||Week 4 vs. Baseline||19.77|-0.55|0.062
71118647|NCT05151445|141742181|OTHER||95% CI|9.78||||0.098|TWO_SIDED|95.0|-2.01|21.56|||McNemar|||Week 8 vs. Baseline||21.56|-2.01|0.098
71118648|NCT05151445|141742181|OTHER||95% CI|17.06||||0.003|TWO_SIDED|95.0|6.51|27.6|||McNemar|||Week 12 vs. Baseline||27.60|6.51|0.003
71118649|NCT05151445|141742182|OTHER|||||||0.37|||||||McNemar|||Week 4 vs. Baseline||||0.37
71118650|NCT05151445|141742182|OTHER|||||||0.724|||||||McNemar|||Week 8 vs. Baseline||||0.724
71118651|NCT05151445|141742182|OTHER|||||||0.289|||||||McNemar|||Week 12 vs. Baseline||||0.289
71118652|NCT05151445|141742183|OTHER|||||||1|||||||McNemar|||Week 4 vs. Baseline||||1.000
71118653|NCT05151445|141742183|OTHER|||||||1|||||||McNemar|||Week 8 vs. Baseline||||1.000
71118654|NCT05151445|141742183|OTHER|||||||1|||||||McNemar|||Weel 12 vs. Baseline||||1.000
71118655|NCT05151445|141742184|OTHER||95% CI|-1.1||||0.696|TWO_SIDED|95.0|-6.96|4.76|||McNemar|||Week 4 vs. Baseline||4.76|-6.96|0.696
71118656|NCT05151445|141742184|OTHER||95% CI|-1.08||||0.734|TWO_SIDED|95.0|-7.72|5.56|||McNemar|||Week 8 vs. Baseline||5.56|-7.72|0.734
71118657|NCT05151445|141742184|OTHER||95% CI|-4.15||||0.249|TWO_SIDED|95.0|-11.53|3.23|||McNemar|||Week 12 vs. Baseline||3.23|-11.53|0.249
71118658|NCT05151445|141742185|OTHER||95% CI|-0.04||||0.989|TWO_SIDED|95.0|-5.25|5.18|||McNemar|||Week 4 vs. Baseline||5.18|-5.25|0.989
71118659|NCT05151445|141742185|OTHER||95% CI|3.43||||0.263|TWO_SIDED|95.0|-2.83|9.69|||McNemar|||Week 8 vs. Baseline||9.69|-2.83|0.263
71118660|NCT05151445|141742185|OTHER||Slope|0.44||||0.882|TWO_SIDED|95.0|-5.8|6.68|||McNemar|||Week 12 vs. Baseline||6.68|-5.80|0.882
71118661|NCT05151445|141742186|OTHER||95% CI|-0.62||||0.425|TWO_SIDED|95.0|-2.23|0.98|||McNemar|||Week 4 vs. Baseline||0.98|-2.23|0.425
71118662|NCT05151445|141742186|OTHER||95% CI|-4.98||||0.205|TWO_SIDED|95.0|-9.08|-0.88|||McNemar|||Week 8 vs. Baseline||-0.88|-9.08|0.205
71118663|NCT05151445|141742186|OTHER||95% CI|-4.98||||0.02|TWO_SIDED|95.0|-9.08|-0.8|||McNemar|||Week 12 vs. Baseline||-0.8|-9.08|0.020
71118664|NCT05151445|141742187|OTHER||95% CI|0.429||||0.429|TWO_SIDED|95.0|-4.9|11.01|||McNemar|||Week 4 vs. Baseline||11.01|-4.90|0.429
71118665|NCT05151445|141742187|OTHER||95% CI|-4.39||||0.255|TWO_SIDED|95.0|-12.24|3.46|||McNemar|||Week 8 vs. Baseline||3.46|-12.24|0.255
71118666|NCT05151445|141742187|OTHER||95% CI|-7.0||||0.102|TWO_SIDED|95.0|-15.55|1.55|||McNemar|||Week 12 vs. Baseline||1.55|-15.55|0.102
71118667|NCT05151445|141742188|OTHER||95% CI|-1.94||||0.568|TWO_SIDED|95.0|-8.99|5.1|||McNemar|||Week 4 vs. Baseline||5.10|-8.99|0.568
71118668|NCT05151445|141742188|OTHER||95% CI|-4.11||||0.198|TWO_SIDED|95.0|-10.59|2.37|||McNemar|||Week 8 vs. Baseline||2.37|-10.59|0.198
71118669|NCT05151445|141742188|OTHER||95% CI|-3.76||||0.225|TWO_SIDED|95.0|-10.08|2.55|||McNemar|||Week 12 vs. Baseline||2.55|-10.08|.225
71118670|NCT01457014|141742251|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|p values have undergone Bonferroni adjustment for Central Apnea Index (CAI), Obstructive Apnea Index (OAI) and Hypopnea Index (HI)||||||<0.001
70943285|NCT03972137|141386957|OTHER|A paired-samples t-test was conducted to compare changes in cigarettes smoked per day from Baseline (BL) to Quit Day.|Mean Difference (Final Values)|11.42|STANDARD_DEVIATION|6.08||0.003|TWO_SIDED|95.0|5.79|17.05||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean cigarettes smoked per day at Baseline and Quit Date (Mean CPD at Baseline - Mean CPD at Quit Date).|||17.05|5.79|.003
71118671|NCT01457014|141742252|SUPERIORITY_OR_OTHER|||||||0.627|TWO_SIDED|||||p value has undergone Bonferroni adjustment. P-Value applies to Av. 02 saturation|Wilcoxon (Mann-Whitney)|p value has undergone Bonferroni adjustment||||||0.627
71118672|NCT01457014|141742253|SUPERIORITY_OR_OTHER|||||||0.161|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.161
71118673|NCT01357161|141742254|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.08|TWO_SIDED|80.0|0.45|0.89|||Cox proportional hazards model|||A stratified \[number of prior platinum based regimens (1 vs. 2 and 3), time since last platinum based therapy (\<12 months vs. ≥12 months)\] Cox proportional hazards model, with Efron method of tie handling, was used to assess the magnitude of the treatment difference between the treatment arms. The p-value from the score test was used in the significance test and the hazard ratio (MK-1775 versus Placebo) and its 95% confidence interval from the same Cox model was reported.||0.89|0.45|0.080
71118674|NCT01357161|141742256|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.55||||0.03|TWO_SIDED|80.0|0.39|0.79|||Cox proportional hazards model|||A stratified \[number of prior platinum based regimens (1 vs. 2 and 3), time since last platinum based therapy (\<12 months vs. ≥12 months)\] Cox proportional hazards model, with Efron method of tie handling, was used to assess the magnitude of the treatment difference between the treatment arms. The p-value from the score test was used in the significance test and the hazard ratio (MK-1775 versus Placebo) and its 95% confidence interval from the same Cox model was reported.||0.79|0.39|0.030
71118675|NCT01357161|141742258|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|3.3|||||TWO_SIDED|95.0|-2.9|11.4||||||P-values and 95% confidence intervals were calculated using the Miettinen and Nurminen method for between-treatment differences (MK-1775 vs. placebo) in the percentage of participants with events.||11.4|-2.9|
71118676|NCT01357161|141742259|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|-1.3|||||TWO_SIDED|95.0|-16.2|13.6||||||P-values and 95% confidence intervals were calculated using the Miettinen and Nurminen method for between-treatment differences (MK-1775 vs. placebo) in the percentage of participants with events.||13.6|-16.2|
71118677|NCT01357161|141742260|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rat|5.2||||0.5247|TWO_SIDED|95.0|-10.9|21.1|||Miettinen and Nurminen's Method|||Stratified Miettinen and Nurminen's method with a two-sided p-Value for testing was used for comparison of the ORRs between the treatment groups in Part 2 portion of the study. A 95% confidence interval (CI) for the difference in response rates was provided.||21.1|-10.9|0.5247
71118678|NCT01357161|141742261|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.15||||0.8|TWO_SIDED|95.0|0.4|3.34|||Cox proportional hazards model|||A stratified \[number of prior platinum based regimens (1 vs. 2 and 3), time since last platinum based therapy (\<12 months vs. ≥12 months)\] Cox proportional hazards model, with Efron method of tie handling, was used to assess the magnitude of the treatment difference between the treatment arms. The p-value from the score test was used in the significance test and the hazard ratio (MK-1775 versus Placebo) and its 95% confidence interval from the same Cox model was reported.||3.34|0.40|0.800
71118679|NCT02825420|141742265|SUPERIORITY|||||||0.007|||||||Log Rank|||||||0.007
71118680|NCT02825420|141742266|SUPERIORITY|||||||0.58|||||||Log Rank|||||||0.58
71118681|NCT02825420|141742267|SUPERIORITY|||||||0.62|||||||Log Rank|||||||0.62
71118682|NCT02825420|141742269|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.010
71118683|NCT02825420|141742271|SUPERIORITY|||||||0.048|||||||Log Rank|||||||0.048
71118684|NCT02825420|141742272|SUPERIORITY|||||||0.51|||||||Log Rank|||||||0.51
71118685|NCT01730339|141742332|SUPERIORITY_OR_OTHER||Least Square mean difference|0.68|STANDARD_ERROR_OF_MEAN|0.29||0.0219|TWO_SIDED|90.0|0.19|1.16|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||1.16|0.19|0.0219
71118686|NCT01730339|141742332|SUPERIORITY_OR_OTHER||Least Square mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.29||0.4038|TWO_SIDED|90.0|-0.24|0.72|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||0.72|-0.24|0.4038
71118687|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.43|0.2||||||Vascularity: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.20|-0.43|
71118688|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|90.0|-0.43|0.11||||||Vascularity: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.11|-0.43|
71118689|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-0.15|0.52||||||Vascularity: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.52|-0.15|
71118690|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.22|0.36||||||Vascularity: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.36|-0.22|
71118691|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|0.07|0.77||||||Vascularity: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.77|0.07|
71118692|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.35|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|0.05|0.65||||||Vascularity: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.65|0.05|
70854759|NCT02312687|141197880|SUPERIORITY||LS Mean|-8.08|||<|0.0001|TWO_SIDED|95.0|-9.86|-6.29||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||-6.29|-9.86|< 0.0001
71080134|NCT04227405|141667051|SUPERIORITY||Slope|0.19|STANDARD_ERROR_OF_MEAN|0.46|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up for the Supportive Dyadic Coping Subscale||||>.05
71080135|NCT04227405|141667053|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.26|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group in the Supportive Dyadic Coping Subcale||||>.05
71080136|NCT04227405|141667053|SUPERIORITY||Slope|1.45|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group in the Supportive Dyadic Coping Scale||||<.001
71080137|NCT04227405|141667053|SUPERIORITY||Slope|1.42|STANDARD_ERROR_OF_MEAN|0.41|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from pre-test to post-test in the intervention group were significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test||||<.01
71080138|NCT04227405|141667053|SUPERIORITY||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.35|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group for the Common Dyadic Coping Subscale||||>.05
71080139|NCT04227405|141667053|SUPERIORITY||Slope|2.12|STANDARD_ERROR_OF_MEAN|0.45|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group in the Common Dyadic Coping Subscale||||<.001
71080140|NCT04227405|141667053|SUPERIORITY||Slope|1.91|STANDARD_ERROR_OF_MEAN|0.55|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from pre-test to post-test in the intervention group were significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test inn the Common Dyadic Coping subscale||||<.01
71080141|NCT04227405|141667053|SUPERIORITY||Slope|-0.68|STANDARD_ERROR_OF_MEAN|0.42|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group for the Negative Dyadic Coping Scale||||>.05
71080142|NCT04227405|141667053|SUPERIORITY||Slope|-1.02|STANDARD_ERROR_OF_MEAN|0.53|<|0.1|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group for the Negative Dyadic Coping Scale||||<.10
71080143|NCT04227405|141667053|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.65|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test for the Negative Dyadic Coping Subscale||||>.05
71080144|NCT02207400|141667082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-11.612|||<|0.0001|TWO_SIDED|95.0|-13.191|-10.033|||ANCOVA||Difference is Sodium Bicarbonate and Sodium Fluoride Dentifrice minus Sodium Fluoride Dentifrice such that a negative difference favors the first named treatment.|||-10.033|-13.191|<0.0001
71080145|NCT02207400|141667083|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.652|||<|0.0001|TWO_SIDED|95.0|-0.738|-0.566|||ANCOVA||Difference is Sodium Bicarbonate and Sodium Fluoride Dentifrice minus Sodium Fluoride Dentifrice such that a negative difference favors the first named treatment.|||-0.566|-0.738|<0.0001
71118693|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|-0.03|0.68||||||Vascularity: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.68|-0.03|
71080146|NCT03372382|141667092|EQUIVALENCE|We prespecified an equivalence margin of -10 to 10mm. We would consider non-opioid analgesia to be equivalent to opioid analgesia if the pain score mean difference between the groups and it's 95% confidence interval (CI) were within the prespecified margin. Pain score mean difference or 95% CI boundaries outside this range would be considered a clinically important difference between treatments|Mean Difference (Final Values)|4.8|||||TWO_SIDED|95.0|-2.1|11.9|||||The upper boundary of the CI is out of pre-specified limits.|Sample size calculations were based on VAS pain score at 2-4 weeks, assuming a mean of 10mm and standard deviation (SD) of 20 mm in the opioid group Assuming a two-sided alpha level of 0.05 and 80% power to detect equivalence, a total of 138 participants would be needed. To account for a 25% expected attrition rate and crossover, a total of 170 participants would be needed.||11.9|-2.1|
71080147|NCT02757352|141667094|SUPERIORITY||Odds Ratio (OR)|2.36||||0.009|TWO_SIDED|95.0|1.23|4.51|||Regression, Logistic|||||4.51|1.23|0.009
70943286|NCT03972137|141386957|OTHER|A paired-samples t-test was used to evaluate smoking reduction in participants from baseline (BL) to 3-month follow-up session (3MFU).|Mean Difference (Final Values)|11.9|STANDARD_DEVIATION|8.45||0.067|TWO_SIDED|95.0|-1.55|25.35||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean cigarettes smoked per day at Baseline and 3-month follow-up. Estimated value reported is reflective of the n=4 participants that attended the 3-month follow-up session.|||25.35|-1.55|.067
70943287|NCT03972137|141386958|OTHER|A paired-samples t-test was conducted to examine the difference in the DASS-21 total score from baseline (BL) to 2-weeks post-quit (2W).|Mean Difference (Final Values)|19.67|STANDARD_DEVIATION|11.91||0.01|TWO_SIDED|95.0|7.17|32.17||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean DASS-21 total scores at Baseline and 2-weeks post-quit. Estimated value reported is reflective of the n=6 participants that attended the 2-weeks post quit session.|||32.17|7.17|.010
70943288|NCT03972137|141386958|OTHER|A paired-samples t-test was conducted to examine the difference in DASS-21 Total scores from baseline (BL) to 1-month post-quit (1M).|Mean Difference (Final Values)|31.2|STANDARD_DEVIATION|20.4||0.027|TWO_SIDED|95.0|5.88|56.52||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean DASS-21 total scores at Baseline and 1-month post-quit. Estimated value reported is reflective of the n=5 participants that attended the 1-month post-quit session.|||56.52|5.88|.027
70943289|NCT03972137|141386958|OTHER|A paired-samples t-test was conducted to evaluate the difference in DASS-21 total scores from baseline (BL) to 3-month follow up (3MFU).|Mean Difference (Final Values)|25.75|STANDARD_DEVIATION|15.5||0.045|TWO_SIDED|95.0|1.09|50.41||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean DASS-21 total scores at Baseline and 3-month follow-up. Estimated value reported is reflective of the n=4 participants that attended the 3-month follow-up session.|||50.41|1.09|.045
70943290|NCT02747121|141386983|OTHER|The intervention was external inspections. This is an organizational level intervention and it does not replace any existing intervention.|Odds Ratio (OR)|1.25||||0.24|TWO_SIDED|95.0|0.86|1.8||We used calculated P-values, however only confidence intervals were reported in the published article.|Mixed Models Analysis|||||1.80|0.86|0.24
70943291|NCT03029234|141386985|OTHER|The prespecified threshold that the primary endpoint would be met was if the lower limit of the 95% confidence interval (CI) was greater than 18%.|Overall response rate|35.8|||||TWO_SIDED|95.0|27.3|44.9||||||||44.9|27.3|
70943292|NCT02166047|141387012|SUPERIORITY||Least Squares (LS) Mean Difference|0.023||||0.59|TWO_SIDED|95.0|-0.061|0.108||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.108|-0.061|0.590
71080148|NCT02757352|141667094|SUPERIORITY||Odds Ratio (OR)|2.78||||0.002|TWO_SIDED|95.0|1.48|5.25|||Regression, Logistic|||||5.25|1.48|0.002
70854760|NCT02312687|141197880|SUPERIORITY||LS Mean|-10.01|||<|0.0001|TWO_SIDED|95.0|-13.07|-6.95||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||-6.95|-13.07|< 0.0001
70854761|NCT02312687|141197880|SUPERIORITY||LS Mean|-10.89|||<|0.0001|TWO_SIDED|95.0|-14.77|-7.02||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||-7.02|-14.77|< 0.0001
70943293|NCT02166047|141387012|SUPERIORITY||LS Mean Difference|0.068||||0.12|TWO_SIDED|95.0|-0.018|0.154||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.154|-0.018|0.120
70943294|NCT02166047|141387012|SUPERIORITY||LS Mean Difference|0.017||||0.701|TWO_SIDED|95.0|-0.069|0.102||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.102|-0.069|0.701
70943295|NCT02166047|141387012|SUPERIORITY||LS Mean Difference|0.082||||0.21|TWO_SIDED|95.0|-0.046|0.21||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.210|-0.046|0.210
70943296|NCT02166047|141387012|SUPERIORITY||LS Mean Difference|0.082||||0.207|TWO_SIDED|95.0|-0.046|0.21||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.210|-0.046|0.207
70943297|NCT02166047|141387012|SUPERIORITY||LS Mean Difference|0.081||||0.216|TWO_SIDED|95.0|-0.048|0.21||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.210|-0.048|0.216
70943298|NCT02166047|141387012|SUPERIORITY||LS Mean Difference|-0.015||||0.652|TWO_SIDED|95.0|-0.081|0.051||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.051|-0.081|0.652
70943299|NCT02166047|141387012|SUPERIORITY||LS Mean Difference|0.0||||0.994|TWO_SIDED|95.0|-0.066|0.065||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.065|-0.066|0.994
70943300|NCT02166047|141387012|SUPERIORITY||LS Mean Difference|0.0||||0.996|TWO_SIDED|95.0|-0.069|0.069||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.069|-0.069|0.996
71080149|NCT02757352|141667095|SUPERIORITY||Odds Ratio (OR)|2.82||||0.004|TWO_SIDED|95.0|1.38|5.77|||Regression, Logistic|||||5.77|1.38|0.004
71080150|NCT02757352|141667095|SUPERIORITY||Odds Ratio (OR)|2.85||||0.004|TWO_SIDED|95.0|1.4|5.77|||Regression, Logistic|||||5.77|1.40|0.004
71080151|NCT02757352|141667096|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.136|<|0.001|TWO_SIDED|95.0|-0.81|-0.28|||Mixed Models Analysis|||||-0.28|-0.81|<0.001
70943301|NCT01960114|141387021|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|25.241|STANDARD_ERROR_OF_MEAN|2.8344|<|0.001|TWO_SIDED|95.0|19.669|30.813||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||30.813|19.669|<0.001
71118694|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.22|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.09|0.52||||||Vascularity: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.52|-0.09|
71118695|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.18|0.42||||||Pigmentation: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.42|-0.18|
71118696|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.35|0.22||||||Pigmentation: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.22|-0.35|
71118697|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|-0.47|0.24||||||Pigmentation: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.24|-0.47|
71118698|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-0.6|0.06||||||Pigmentation: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.06|-0.60|
71118699|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.35|0.41||||||Pigmentation: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.41|-0.35|
71118700|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|-0.33|0.37||||||Pigmentation: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.37|-0.33|
71118701|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.24|0.53||||||Pigmentation: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.53|-0.24|
71118702|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|-0.39|0.32||||||Pigmentation: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.32|-0.39|
71118703|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-0.22|0.58||||||Thickness: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.58|-0.22|
71118704|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.42|0.35||||||Thickness: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.35|-0.42|
71118705|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-0.05|0.84||||||Thickness: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.84|-0.05|
71118706|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.62|0.23||||||Thickness: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.23|-0.62|
71118707|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.94|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|0.4|1.49||||||Thickness: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.49|0.40|
71118708|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|90.0|-0.3|0.72||||||Thickness: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.72|-0.30|
71118709|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.68|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|0.13|1.24||||||Thickness: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.24|0.13|
71118710|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|-0.38|0.67||||||Thickness: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.67|-0.38|
71118711|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.39|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-0.01|0.78||||||Relief: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.78|-0.01|
71118712|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.5|0.28||||||Relief: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.28|-0.50|
71118713|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.22|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-0.23|0.67||||||Relief: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.67|-0.23|
70871994|NCT03919799|141229339|SUPERIORITY||Least square mean difference|0.039||||0.8234|TWO_SIDED|95.0|-0.317|0.395||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||0.395|-0.317|0.8234
70943302|NCT01960114|141387022|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
70854762|NCT02312687|141197881|SUPERIORITY||LS Mean|343.38||||0.0113|TWO_SIDED|95.0|77.66|609.11||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||609.11|77.66|0.0113
70854763|NCT02312687|141197881|SUPERIORITY||LS Mean|41.45||||0.4972|TWO_SIDED|95.0|-78.23|161.13||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||161.13|-78.23|0.4972
70854764|NCT02312687|141197881|SUPERIORITY||LS Mean|-61.96||||0.3288|TWO_SIDED|95.0|-186.34|62.41||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||62.41|-186.34|0.3288
70854765|NCT02312687|141197881|SUPERIORITY||LS Mean|-68.62||||0.2772|TWO_SIDED|95.0|-192.39|55.16||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||55.16|-192.39|0.2772
70943303|NCT01960114|141387023|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
70943304|NCT01960114|141387024|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The significance threshold level was 0.05 (two-sided). p-Values are based on the log-rank test from PROC LIFETEST that compared survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 12 hours, but did not use rescue therapy, were censored at the time of withdrawal. Subjects not rescuing during the 12-hour study period had their time to rescue set to 12 hours and were censored.||||<0.001
70943305|NCT01960114|141387025|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Used row-mean scores based on Cochran-Mantel-Haenszel test was stratified by baseline categorical pain score.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.001
70943306|NCT02469077|141387026|SUPERIORITY|||||||0.12|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.12
70943307|NCT02469077|141387027|SUPERIORITY|||||||0.04|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||.04
70943308|NCT02469077|141387028|SUPERIORITY|||||||0.03|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||.03
70943309|NCT02469077|141387029|SUPERIORITY|||||||0.17|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.17
70943310|NCT02469077|141387030|SUPERIORITY|||||||0.13|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.13
70943311|NCT02469077|141387031|SUPERIORITY|||||||0.98|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||.98
70943312|NCT02469077|141387032|SUPERIORITY|||||||0.52|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.52
70943313|NCT02469077|141387033|SUPERIORITY|||||||0.65|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.65
70943314|NCT02469077|141387034|SUPERIORITY|||||||0.1|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.1
70943315|NCT02469077|141387035|SUPERIORITY|||||||0.046|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||.046
70943316|NCT02469077|141387036|SUPERIORITY|||||||0.61|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.61
70943317|NCT02469077|141387037|SUPERIORITY|||||||0.4|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.4
70943318|NCT02469077|141387038|SUPERIORITY|||||||0.57|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.57
70943319|NCT00991029|141387039|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.02|TWO_SIDED|95.0|0.59|0.95|||Log Rank|||||0.95|0.59|0.02
70943320|NCT00991029|141387040|SUPERIORITY||Hazard Ratio (HR)|2.32||||0.02|TWO_SIDED|95.0|1.1|4.87|||Log Rank|||||4.87|1.10|0.02
70943321|NCT00991029|141387041|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.01|TWO_SIDED|95.0|0.56|0.92|||Log Rank|||||0.92|0.56|0.01
70943322|NCT00991029|141387042|SUPERIORITY||Hazard Ratio (HR)|1.44||||0.46|TWO_SIDED|95.0|0.55|3.78|||Log Rank|||||3.78|0.55|0.46
70943323|NCT00991029|141387043|SUPERIORITY||Hazard Ratio (HR)|1.51||||0.52|TWO_SIDED|95.0|0.43|5.35|||Log Rank|||||5.35|0.43|0.52
70943324|NCT00991029|141387044|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.01|TWO_SIDED|95.0|0.58|0.94|||Log Rank|||||0.94|0.58|0.01
70943325|NCT00991029|141387045|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.13|TWO_SIDED|95.0|0.67|1.05|||Log Rank|||||1.05|0.67|0.13
70943326|NCT00991029|141387046|SUPERIORITY||Hazard Ratio (HR)|1.68||||0.47|TWO_SIDED|95.0|0.4|7.03|||Log Rank|||||7.03|0.4|0.47
70943327|NCT00991029|141387047|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.99|TWO_SIDED|95.0|0.14|7.14|||Log Rank|||||7.14|0.14|0.99
70943328|NCT00991029|141387048|SUPERIORITY|||||||0.16|||||||Log Rank|||||||0.16
70943329|NCT00991029|141387049|SUPERIORITY||Hazard Ratio (HR)|2.45||||0.04|TWO_SIDED|95.0|1.01|5.9|||Log Rank|||||5.9|1.01|0.04
70943330|NCT00991029|141387050|SUPERIORITY||Hazard Ratio (HR)|3.12|||<|0.001|TWO_SIDED|95.0|1.67|5.83|||Log Rank|||||5.83|1.67|<0.001
70943331|NCT00991029|141387051|SUPERIORITY||Hazard Ratio (HR)|1.51||||0.27|TWO_SIDED|95.0|0.73|3.13|||Log Rank|||||3.13|0.73|0.27
70943332|NCT01318538|141387052|SUPERIORITY_OR_OTHER|||||||0.821|TWO_SIDED|95.0|||||loglinear (negative binomial) regression|Analyzed using loglinear (negative binomial) regression models with estimation via generalized estimating equations (relative changes i.e. % change)||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.The study was powered for the primary analysis concerning treatment group differences in the degree of improvement in the number of days of any substance use and in the Addiction Severity Index (ASI) composite scores. With a total of 100 women, the study was adequately powered to detect a minimum 5 day benefit in the # of days of any substance use (power = 83%).||||0.821
70954234|NCT00688870|141411076|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|1.03|||||TWO_SIDED|95.0|0.77|1.36|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 6B||1.36|0.77|
70854766|NCT02312687|141197881|SUPERIORITY||LS Mean|-53.41||||0.2907|TWO_SIDED|95.0|-152.47|45.66||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||45.66|-152.47|0.2907
70871995|NCT03919799|141229340|SUPERIORITY||Least square mean difference|-3.009||||0.7535|TWO_SIDED|95.0|-22.413|16.395||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||16.395|-22.413|0.7535
70943333|NCT01318538|141387053|SUPERIORITY_OR_OTHER|||||||0.519|||||||loglinear (negative binomial) regression|We used loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE).||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. Note: Women in both WRG and GDC groups had significant (p\<0.0001 reductions in mean # of alcohol use days during treatment (9.9 and 12.4 day reductions for WRG and GDC respectively) and at 6 months post-treatment (8.3 and 12.2 day reductions).||||0.519
70854767|NCT02312687|141197881|SUPERIORITY||LS Mean|-97.46||||0.08|TWO_SIDED|95.0|-206.57|11.65||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||11.65|-206.57|0.0800
71080152|NCT02757352|141667096|SUPERIORITY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.134|<|0.001|TWO_SIDED|95.0|-0.94|-0.41|||Mixed Models Analysis|||||-0.41|-0.94|<0.001
70871996|NCT03919799|141229340|SUPERIORITY||Least square mean difference|-21.015||||0.0348|TWO_SIDED|95.0|-40.419|-1.611||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||-1.611|-40.419|0.0348
71118714|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.63|0.24||||||Relief: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.24|-0.63|
71118715|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.74|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|90.0|0.21|1.26||||||Relief: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.26|0.21|
71118716|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|-0.41|0.59||||||Relief: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.59|-0.41|
71118717|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.52|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|0.02|1.02||||||Relief: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.02|0.02|
71118718|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-0.33|0.63||||||Relief: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.63|-0.33|
71118719|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.09|0.67||||||Pliability: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.67|-0.09|
71118720|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|-0.39|0.34||||||Pliability: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.34|-0.39|
71118721|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.31|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.12|0.74||||||Pliability: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.74|-0.12|
71118722|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.76|0.05||||||Pliability: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.05|-0.76|
71118723|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.73|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|0.25|1.2||||||Pliability: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.20|0.25|
71118724|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-0.46|0.42||||||Pliability: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.42|-0.46|
71118725|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.53|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|90.0|0.01|1.05||||||Pliability: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.05|0.01|
71118726|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.49|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|0.0|0.98||||||Pliability: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.98|0.00|
71118727|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-0.29|0.62||||||Surface Area: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.62|-0.29|
71118728|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|-0.28|0.43||||||Surface Area: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.43|-0.28|
71118729|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.51|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|0.02|1.0||||||Surface Area: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.00|0.02|
71118730|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.53|0.23||||||Surface Area: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.23|-0.53|
71118731|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.64|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|0.08|1.2||||||Surface Area: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.20|0.08|
71118732|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.44|0.42||||||Surface Area : Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.42|-0.44|
71118733|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.69|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|0.09|1.28||||||Surface Area: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.28|0.09|
71118734|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-0.23|0.69||||||Surface Area: week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.69|-0.23|
71080153|NCT02757352|141667097|SUPERIORITY||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.179|<|0.001|TWO_SIDED|95.0|-0.96|-0.26|||Mixed Models Analysis|||||-0.26|-0.96|<0.001
70854768|NCT02312687|141197882|SUPERIORITY||LS Mean|72.45|||<|0.0001|TWO_SIDED|95.0|39.21|105.7||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||105.70|39.21|< 0.0001
70854769|NCT02312687|141197882|SUPERIORITY||LS Mean|44.4|||<|0.0001|TWO_SIDED|95.0|30.34|58.47||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||58.47|30.34|< 0.0001
70854770|NCT02312687|141197882|SUPERIORITY||LS Mean|28.3||||0.0002|TWO_SIDED|95.0|13.24|43.37||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||43.37|13.24|0.0002
71080154|NCT02757352|141667097|SUPERIORITY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.178|<|0.001|TWO_SIDED|95.0|-1.05|-0.34|||Mixed Models Analysis|||||-0.34|-1.05|<0.001
71080155|NCT02757352|141667099|SUPERIORITY||LS Mean Difference|2.8509|STANDARD_ERROR_OF_MEAN|1.139||0.013|TWO_SIDED|95.0|0.6092|5.0926|||Mixed Models Analysis|||||5.0926|0.6092|0.013
70854771|NCT02312687|141197882|SUPERIORITY||LS Mean|27.02|||<|0.0001|TWO_SIDED|95.0|13.81|40.22||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||40.22|13.81|< 0.0001
70854772|NCT02312687|141197882|SUPERIORITY||LS Mean|13.02||||0.1195|TWO_SIDED|95.0|-3.37|29.4||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||29.40|-3.37|0.1195
70854773|NCT02312687|141197882|SUPERIORITY||LS Mean|43.12||||0.2009|TWO_SIDED|95.0|-22.96|109.2||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||109.20|-22.96|0.2009
70854774|NCT00167778|141197929|SUPERIORITY_OR_OTHER||||||>|0.99||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||>0.99
70854775|NCT00167778|141197930|SUPERIORITY_OR_OTHER||||||=|0.09||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||=0.09
70854776|NCT00167778|141197931|SUPERIORITY_OR_OTHER||||||=|0.09||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||=0.09
70854777|NCT00167778|141197932|SUPERIORITY_OR_OTHER||||||=|0.7||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||=0.7
70854778|NCT00167778|141197933|SUPERIORITY_OR_OTHER||||||>|0.99||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||>0.99
70854779|NCT00167778|141197935|SUPERIORITY_OR_OTHER||||||=|0.8||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||=0.8
70854780|NCT00167778|141197936|SUPERIORITY_OR_OTHER||||||=|0.7||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||=0.7
70854781|NCT00167778|141197937|SUPERIORITY_OR_OTHER||||||=|0.4||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||=.4
70854782|NCT00167778|141197938|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Statistical significance was set a-prior at p\<0.05. Values of p\>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.||||||>0.15
70854783|NCT00167778|141197939|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Statistical significance was set a-prior at p\<0.05. Values of p\>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.||||||>0.15
70854784|NCT00167778|141197940|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Statistical significance was set a-prior at p\<0.05. Values of p\>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.||||||>0.15
70854785|NCT00167778|141197941|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Statistical significance was set a-prior at p\<0.05. Values of p\>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.||||||>0.15
70854786|NCT00167778|141197942|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Statistical significance was set a-prior at p\<0.05. Values of p\>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.||||||>0.15
70854787|NCT00167778|141197943|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Statistical significance was set a-prior at p\<0.05. Values of p\>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.||||||>0.15
70854788|NCT00167778|141197944|SUPERIORITY_OR_OTHER||||||=|0.13||95.0||||Statistical significance was set a-prior at p\<0.05.|Wilcoxon (Mann-Whitney)|Wilcoon paired signed rank test for the differences between Rigid and Torsion Adapter pylons||||||=0.13
70854789|NCT00167778|141197945|SUPERIORITY_OR_OTHER||||||=|0.92||95.0||||Statistical significance was set a-prior at p\<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between Rigid and Torsion Adapter pylons.||||||=0.92
70854790|NCT00167778|141197946|SUPERIORITY_OR_OTHER||||||=|0.37||95.0||||Statistical significance was set a-prior at p\<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.||||||=0.37
70854791|NCT00167778|141197947|SUPERIORITY_OR_OTHER||||||=|0.27||95.0||||Statistical significance was set a-prior at p\<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.||||||=0.27
70854792|NCT00167778|141197948|SUPERIORITY_OR_OTHER||||||=|0.2||95.0||||Statistical significance was set a-prior at p\<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.||||||=0.20
70854793|NCT00167778|141197949|SUPERIORITY_OR_OTHER||||||=|0.59||95.0||||Statistical significance was set a-prior at p\<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.||||||=0.59
70854794|NCT00167778|141197950|SUPERIORITY_OR_OTHER||||||=|0.057||95.0||||Statistical significance was set a-prior at p\<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.||||||=0.057
70854795|NCT00167778|141197951|SUPERIORITY_OR_OTHER||||||=|0.78||95.0||||Statistical significance was set a-prior at p\<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.||||||=0.78
70854796|NCT01976988|141197992|SUPERIORITY_OR_OTHER|||||||0.72|||||||Fisher Exact|||||||0.72
70854797|NCT01976988|141197993|SUPERIORITY_OR_OTHER|||||||0.36|||||||Fisher Exact|||||||0.36
70854798|NCT01976988|141197994|SUPERIORITY_OR_OTHER|||||||0.03|||||||Fisher Exact|||||||0.03
70854799|NCT01976988|141197995|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1
70854800|NCT01976988|141197996|SUPERIORITY_OR_OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
70854801|NCT01976988|141197997|SUPERIORITY_OR_OTHER|||||||0.34|||||||Fisher Exact|||||||0.34
70854802|NCT01332461|141198009|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.649||||0.05|TWO_SIDED|95.0|0.455|0.926|||Log Rank||Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.|||0.926|0.455|0.05
71118735|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.22||0.2778|TWO_SIDED|90.0|-0.12|0.6|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||Overall Opinion: Week 8 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||0.60|-0.12|0.2778
71118736|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.22||0.6888|TWO_SIDED|90.0|-0.28|0.45|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||Overall Opinion: Weekl 8 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||0.45|-0.28|0.6888
71118737|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.25||0.3515|TWO_SIDED|90.0|-0.18|0.65|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||Overall Opinion: Weekl 11 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||0.65|-0.18|0.3515
71118738|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.25||0.3788|TWO_SIDED|90.0|-0.64|0.19|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||Overall Opinion: Weekl 11 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||0.19|-0.64|0.3788
71118739|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.82|STANDARD_ERROR_OF_MEAN|0.28||0.0044|TWO_SIDED|90.0|0.35|1.29|||Repeated measures model|||Overall Opinion: Weekl 18 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||1.29|0.35|0.0044
71118740|NCT01730339|141742333|SUPERIORITY_OR_OTHER||Least Square mean difference|0.11|STANDARD_ERROR_OF_MEAN|0.28||0.6848|TWO_SIDED|90.0|-0.35|0.58|||Repeated measures model|||Overall Opinion: Weekl 18 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||0.58|-0.35|0.6848
71118741|NCT01730339|141742334|SUPERIORITY_OR_OTHER||Least Square mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.32||0.7552|TWO_SIDED|90.0|-0.44|0.64|||Repeated measures model|||Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.64|-0.44|0.7552
71118742|NCT01730339|141742334|SUPERIORITY_OR_OTHER||LS mean difference|0.11|STANDARD_ERROR_OF_MEAN|0.25||0.6605|TWO_SIDED|90.0|-0.3|0.52|||Repeated measures model|||Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.52|-0.30|0.6605
71118743|NCT01730339|141742334|SUPERIORITY_OR_OTHER||Least Square mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.33||0.9842|TWO_SIDED|90.0|-0.55|0.56|||Repeated measures model|||Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.56|-0.55|0.9842
71118744|NCT01730339|141742334|SUPERIORITY_OR_OTHER||Least Square mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.25||0.401|TWO_SIDED|90.0|-0.21|0.63|||Repeated measures model|||Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.63|-0.21|0.4010
71118745|NCT01730339|141742334|SUPERIORITY_OR_OTHER||Least Square mean difference|0.44|STANDARD_ERROR_OF_MEAN|0.38||0.2491|TWO_SIDED|90.0|-0.19|1.07|||Repeated measures model|||Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.07|-0.19|0.2491
71118746|NCT01730339|141742334|SUPERIORITY_OR_OTHER||Least Square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.29||0.998|TWO_SIDED|90.0|-0.47|0.47|||Repeated measures model|||Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.47|-0.47|0.9980
71118747|NCT01730339|141742334|SUPERIORITY_OR_OTHER||Least Square mean difference|0.28|STANDARD_ERROR_OF_MEAN|0.39||0.473|TWO_SIDED|90.0|-0.37|0.93|||Repeated measures model|||Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.93|-0.37|0.4730
71118748|NCT01730339|141742334|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.3||0.5413|TWO_SIDED|90.0|-0.67|0.31|||Repeated measures model|||Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.31|-0.67|0.5413
70854803|NCT01332461|141198010|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.601|||<|0.05|TWO_SIDED|95.0|0.326|1.109||COPD-related hospitalization|Log Rank||Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.|||1.109|0.326|<0.05
70954235|NCT00688870|141411076|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.82|||||TWO_SIDED|95.0|0.64|1.05|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 9V||1.05|0.64|
71080156|NCT02757352|141667099|SUPERIORITY||LS Mean Difference|2.7497|STANDARD_ERROR_OF_MEAN|1.1278||0.015|TWO_SIDED|95.0|0.5299|4.9694|||Mixed Models Analysis|||||4.9694|0.5299|0.015
71080157|NCT02757352|141667100|SUPERIORITY||LS Mean Difference|4.2001|STANDARD_ERROR_OF_MEAN|1.6467||0.012|TWO_SIDED|95.0|0.9525|7.4477|||Mixed Models Analysis|||||7.4477|0.9525|0.012
71080158|NCT02757352|141667100|SUPERIORITY||LS Mean Difference|4.6081|STANDARD_ERROR_OF_MEAN|1.6455||0.006|TWO_SIDED|95.0|1.3629|7.8533|||Mixed Models Analysis|||||7.8533|1.3629|0.006
70943334|NCT01318538|141387054|SUPERIORITY_OR_OTHER|||||||0.253|TWO_SIDED|95.0|||||Linear mixed effect models|This measure was analyzed using using linear mixed effect models with estimation via restricted maximum likelihood (absolute changes in the mean).||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. The study was powered for the primary analysis concerning treatment group differences in the degree of improvement in the number of days of any substance use and in the Addiction Severity Index (ASI) composite scores.With 100 women (50 in each treatment group), the study was adequately powered to detect a 0.2 benefit in the ASI drug and alcohol composite scores (power = 94%).||||0.253
70943335|NCT01318538|141387055|SUPERIORITY_OR_OTHER|||||||0.667|TWO_SIDED|95.0|||||Linear mixed effect models|This measure was analyzed using using linear mixed effect models with estimation via restricted maximum likelihood (absolute changes in the mean).||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. The study was powered for the primary analysis concerning treatment group differences in the degree of improvement in the number of days of any substance use and in the Addiction Severity Index (ASI) composite scores.With 100 women (50 in each treatment group), the study was adequately powered to detect a 0.2 benefit in the ASI drug and alcohol composite scores (power = 94%).||||0.667
70871997|NCT03919799|141229341|SUPERIORITY||Least square mean difference|45.566||||0.0343|TWO_SIDED|95.0|3.621|87.512||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||87.512|3.621|0.0343
70943336|NCT01318538|141387057|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
70943337|NCT01318538|141387058|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
70943338|NCT01318538|141387059|SUPERIORITY_OR_OTHER|||||||0.464|||||||loglinear (negative binomial) regression|We used loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE).||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. Note: Women in both WRG and GDC groups had significant (p\<0.05) reductions in mean number of drug use days during treatment (3.0 and 1.5 day reductions for WRG and GDC respectively); however at 6 months post-treatment, the reductions were significant for WRG (2.8 day reduction; p\<0.05) but not for GDC (1.5 day reduction; p\>0.01).||||0.464
71080159|NCT02757352|141667101|SUPERIORITY||Odds Ratio (OR)|2.73||||0.008|TWO_SIDED|95.0|1.3|5.76|||Regression, Logistic|||||5.76|1.30|0.008
70943339|NCT01318538|141387060|SUPERIORITY_OR_OTHER|||||||0.904|||||||loglinear (negative binomial) regression|We used loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE).||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. Note: Women in both WRG and GDC groups had significant (p\<0.0001) reductions in mean number of heavy drinking days during treatment (8.6 and 12.1 days reduction for WRG and GDC, respectively) and at 6 months post-treatment (8.0 and 11.8 day reductions).||||0.904
70943340|NCT01318538|141387061|SUPERIORITY_OR_OTHER|||||||0.799|||||||linear mixed effect model|This measure was analyzed using using linear mixed effect models with estimation via restricted maximum likelihood (absolute changes in the mean).||The models included the effects of treatment group, phase (3 levels), and the treatment by phase interaction. Note: Women in both the WRG and GDC groups had significant (p\<0.05) reductions in mean number of drinks per drinking day only during the in treatment phase (2.0 and 2.9 reductions for WRG and GDC, respectively).||||0.799
70854804|NCT01332461|141198010|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.651|||<|0.05|TWO_SIDED|95.0|0.434|0.977||COPD-related ER visit|Log Rank||Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.|||0.977|0.434|<0.05
70943341|NCT02845375|141387081|SUPERIORITY|||||||0.299|||||||ANCOVA|||||||0.299
70943342|NCT05215418|141387082|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.|||||<|0.001|||||||ANCOVA|||||||< 0.001
70943343|NCT05215418|141387082|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.0059|||||||ANCOVA|||||||0.0059
70943344|NCT05215418|141387082|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.1867|||||||ANCOVA|||||||0.1867
70943345|NCT05215418|141387083|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.0277|||||||ANCOVA|||||||0.0277
70943346|NCT05215418|141387083|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.0852|||||||ANCOVA|||||||0.0852
70943347|NCT05215418|141387083|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.|||||<|0.0001|||||||ANCOVA|||||||<.0001
70943348|NCT05215418|141387084|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.0109|||||||ANCOVA|||In-clinic systolic blood pressure||||0.0109
70943349|NCT05215418|141387084|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.0339|||||||ANCOVA|||In-clinic systolic blood pressure||||0.0339
70943350|NCT05215418|141387084|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.6769|||||||ANCOVA|||In-clinic systolic blood pressure||||0.6769
71080160|NCT02757352|141667101|SUPERIORITY||Odds Ratio (OR)|3.43|||<|0.001|TWO_SIDED|95.0|1.66|7.08|||Regression, Logistic|||||7.08|1.66|<0.001
70954236|NCT00688870|141411076|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.68|||||TWO_SIDED|95.0|0.51|0.91|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 14||0.91|0.51|
71118749|NCT01730339|141742335|SUPERIORITY_OR_OTHER||Least Square mean difference|1.32|STANDARD_ERROR_OF_MEAN|2.76|||TWO_SIDED|90.0|-3.28|5.92||||||Appearance: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||5.92|-3.28|
71118750|NCT01730339|141742335|SUPERIORITY_OR_OTHER||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|1.97|||TWO_SIDED|90.0|-3.63|2.91||||||Appearance: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||2.91|-3.63|
71118751|NCT01730339|141742335|SUPERIORITY_OR_OTHER||Least Square mean difference|3.82|STANDARD_ERROR_OF_MEAN|3.85|||TWO_SIDED|90.0|-2.6|10.24||||||Appearance: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||10.24|-2.60|
71118752|NCT01730339|141742335|SUPERIORITY_OR_OTHER||Least Square mean difference|0.16|STANDARD_ERROR_OF_MEAN|2.72|||TWO_SIDED|90.0|-4.37|4.68||||||Appearance: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||4.68|-4.37|
71118753|NCT01730339|141742335|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.7|STANDARD_ERROR_OF_MEAN|2.19|||TWO_SIDED|90.0|-4.34|2.95||||||Symptoms: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||2.95|-4.34|
71118754|NCT01730339|141742335|SUPERIORITY_OR_OTHER||Least Square mean difference|-1.54|STANDARD_ERROR_OF_MEAN|1.8|||TWO_SIDED|90.0|-4.53|1.45||||||Symptoms: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.45|-4.53|
71118755|NCT01730339|141742335|SUPERIORITY_OR_OTHER||Least Square mean difference|1.75|STANDARD_ERROR_OF_MEAN|2.3|||TWO_SIDED|90.0|-2.07|5.58||||||Symptoms: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||5.58|-2.07|
71118756|NCT01730339|141742335|SUPERIORITY_OR_OTHER||Least Square mean difference|-1.13|STANDARD_ERROR_OF_MEAN|1.87|||TWO_SIDED|90.0|-4.24|1.99||||||Symptoms: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.99|-4.24|
71118757|NCT01730339|141742336|SUPERIORITY_OR_OTHER||Least Square mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.15|0.35||||||Physician: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.35|-0.15|
71118758|NCT01730339|141742336|SUPERIORITY_OR_OTHER||Least Square mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|90.0|-0.22|0.29||||||Physician: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.29|-0.22|
71118759|NCT01730339|141742336|SUPERIORITY_OR_OTHER||Least Square mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.04|0.54||||||Physician: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.54|0.04|
71118760|NCT01730339|141742336|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.36|0.15||||||Physician: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.15|-0.36|
71118761|NCT01730339|141742336|SUPERIORITY_OR_OTHER||Least Square mean difference|0.57|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.32|0.82||||||Physician: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.82|0.32|
71118762|NCT01730339|141742336|SUPERIORITY_OR_OTHER||Least Square mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.21|0.3||||||Physician: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.30|-0.21|
71118763|NCT01730339|141742336|SUPERIORITY_OR_OTHER||Least Square mean difference|0.43|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.18|0.68||||||Physician: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.68|0.18|
71118764|NCT01730339|141742336|SUPERIORITY_OR_OTHER||Least Square mean difference|0.07|STANDARD_DEVIATION|0.15|||TWO_SIDED|90.0|-0.18|0.32||||||Physician: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.32|-0.18|
71118765|NCT01730339|141742336|SUPERIORITY_OR_OTHER||Least Square mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.2|0.39||||||Participant: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.39|-0.20|
71118766|NCT01730339|141742336|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.28|0.23||||||Participant: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.23|-0.28|
71080161|NCT02757352|141667102|SUPERIORITY||Odds Ratio (OR)|4.58|||<|0.001|TWO_SIDED|95.0|2.02|10.41|||Regression, Logistic|||||10.41|2.02|<0.001
71118767|NCT01730339|141742336|SUPERIORITY_OR_OTHER||Least Square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.29|0.3||||||Participant: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.30|-0.29|
71118768|NCT01730339|141742336|SUPERIORITY_OR_OTHER||Least Square mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.18|0.33||||||Participant: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.33|-0.18|
70854805|NCT01332461|141198010|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.815|||<|0.05|TWO_SIDED|95.0|0.658|1.008||COPD-related physician + Rx visit|Log Rank||Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.|||1.008|0.658|<0.05
71080162|NCT02757352|141667102|SUPERIORITY||Odds Ratio (OR)|3.99|||<|0.001|TWO_SIDED|95.0|1.76|9.05|||Regression, Logistic|||||9.05|1.76|<0.001
71080163|NCT02757352|141667103|SUPERIORITY||LS Means Square Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.308||0.031|TWO_SIDED|95.0|-1.28|-0.06|||Mixed Models Analysis|||||-0.06|-1.28|0.031
71080164|NCT02757352|141667103|SUPERIORITY||LS Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.305||0.001|TWO_SIDED|95.0|-1.61|-0.41|||Mixed Models Analysis|||||-0.41|-1.61|0.001
71080165|NCT02757352|141667104|SUPERIORITY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.404||0.006|TWO_SIDED|95.0|-1.92|-0.33|||Mixed Models Analysis|||||-0.33|-1.92|0.006
71080166|NCT02757352|141667104|SUPERIORITY||LS Mean Difference|-1.29|STANDARD_ERROR_OF_MEAN|0.404||0.002|TWO_SIDED|95.0|-2.08|-0.49|||Mixed Models Analysis|||||-0.49|-2.08|0.002
71080167|NCT02757352|141667105|SUPERIORITY||LS Mean Difference|-3.07|STANDARD_ERROR_OF_MEAN|0.764|<|0.001|TWO_SIDED|95.0|-4.58|-1.57|||ANCOVA|||||-1.57|-4.58|<0.001
71080168|NCT02757352|141667105|SUPERIORITY||LS Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|0.751|<|0.001|TWO_SIDED|95.0|-5.68|-2.72|||ANCOVA|||||-2.72|-5.68|<0.001
71080169|NCT02757352|141667106|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.621||0.849|TWO_SIDED|95.0|-1.35|1.11|||Mixed Models Analysis|||||1.11|-1.35|0.849
71118769|NCT01730339|141742336|SUPERIORITY_OR_OTHER||Least Square mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|0.12|0.72||||||Participant: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.72|0.12|
71118770|NCT01730339|141742336|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.27|0.24||||||Participant: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.24|-0.27|
71080170|NCT02757352|141667106|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.608||0.648|TWO_SIDED|95.0|-1.48|0.93|||Mixed Models Analysis|||||0.93|-1.48|0.648
71080171|NCT02757352|141667107|SUPERIORITY||LS Mean Difference|-1.06|STANDARD_ERROR_OF_MEAN|0.443||0.018|TWO_SIDED|95.0|-1.93|-0.18|||Mixed Models Analysis|||||-0.18|-1.93|0.018
71080172|NCT02757352|141667107|SUPERIORITY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.442||0.008|TWO_SIDED|95.0|-2.05|-0.31|||Mixed Models Analysis|||||-0.31|-2.05|0.008
71080173|NCT02757352|141667108|SUPERIORITY||Odds Ratio (OR)|5.33||||0.0011|TWO_SIDED|96.0|1.47|19.4|||Regression, Logistic|||||19.40|1.47|0.0011
71080174|NCT02757352|141667108|SUPERIORITY||Odds Ratio (OR)|4.22||||0.031|TWO_SIDED|95.0|1.14|15.66|||Regression, Logistic|||||15.66|1.14|0.031
71080175|NCT02757352|141667109|SUPERIORITY||LS Mean Difference|-3.807|STANDARD_ERROR_OF_MEAN|2.8507||0.183|TWO_SIDED|95.0|-9.418|1.804|||Mixed Models Analysis|||||1.804|-9.418|0.183
71080176|NCT02757352|141667109|SUPERIORITY||LS Mean Difference|-2.743|STANDARD_ERROR_OF_MEAN|2.8202||0.331|TWO_SIDED|95.0|-8.294|2.807|||Mixed Models Analysis|||||2.807|-8.294|0.331
71080177|NCT02757352|141667110|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.148||0.008|TWO_SIDED|95.0|-0.69|-0.1|||Mixed Models Analysis|||||-0.10|-0.69|0.008
71080178|NCT02757352|141667110|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.148||0.038|TWO_SIDED|95.0|-0.6|-0.02|||Mixed Models Analysis|||||-0.02|-0.60|0.038
71080179|NCT02757352|141667111|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.325||0.871|TWO_SIDED|95.0|-0.59|0.7|||Mixed Models Analysis|||||0.70|-0.59|0.871
71080180|NCT02757352|141667111|SUPERIORITY||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.327||0.295|TWO_SIDED|95.0|-0.3|0.99|||Mixed Models Analysis|||||0.99|-0.30|0.295
71080181|NCT02757352|141667112|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.406||0.257|TWO_SIDED|95.0|-1.26|0.34|||Mixed Models Analysis|||||0.34|-1.26|0.257
71080182|NCT02757352|141667112|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.402||0.057|TWO_SIDED|95.0|-1.56|0.02|||Mixed Models Analysis|||||0.02|-1.56|0.057
71080183|NCT02757352|141667113|SUPERIORITY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.496||0.082|TWO_SIDED|95.0|-1.85|0.11|||Mixed Models Analysis|||||0.11|-1.85|0.082
71080184|NCT02757352|141667113|SUPERIORITY||LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.493||0.088|TWO_SIDED|95.0|-1.82|0.13|||Mixed Models Analysis|||||0.13|-1.82|0.088
71080185|NCT02757352|141667114|SUPERIORITY||LS Mean Difference|-1.79|STANDARD_ERROR_OF_MEAN|1.442||0.219|TWO_SIDED|95.0|-4.66|1.09|||Mixed Models Analysis|||TJC||1.09|-4.66|0.219
71080186|NCT02757352|141667114|SUPERIORITY||LS Mean Difference|-3.53|STANDARD_ERROR_OF_MEAN|1.388||0.013|TWO_SIDED|95.0|-6.3|-0.76|||Mixed Models Analysis|||TJC||-0.76|-6.30|0.013
71080187|NCT02757352|141667114|SUPERIORITY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.355||0.009|TWO_SIDED|95.0|-1.68|-0.26|||Mixed Models Analysis|||SJC||-0.26|-1.68|0.009
71080188|NCT02757352|141667114|SUPERIORITY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.348||0.034|TWO_SIDED|95.0|-1.46|-0.06|||Mixed Models Analysis|||SJC||-0.06|-1.46|0.034
71080189|NCT02757352|141667116|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.5||0.325|TWO_SIDED|95.0|-1.5|0.5|||Mixed Models Analysis|||||0.5|-1.5|0.325
71080190|NCT02757352|141667116|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.5||0.206|TWO_SIDED|95.0|-1.6|0.4|||Mixed Models Analysis|||||0.4|-1.6|0.206
71080191|NCT02757352|141667117|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.601||0.33|TWO_SIDED|95.0|-1.77|0.6|||Mixed Models Analysis|||||0.60|-1.77|0.330
71118771|NCT01730339|141742336|SUPERIORITY_OR_OTHER||Least Square mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.09|0.5||||||Participant: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.50|-0.09|
70943351|NCT05215418|141387084|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.0082|||||||ANCOVA|||In-clinic diastolic blood pressure||||0.0082
70943352|NCT05215418|141387084|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.8131|||||||ANCOVA|||In-clinic diastolic blood pressure||||0.8131
70943353|NCT05215418|141387084|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.015|||||||ANCOVA|||In-clinic diastolic blood pressure||||0.0150
70943354|NCT01177137|141387085|SUPERIORITY||Slope|-2.35|STANDARD_ERROR_OF_MEAN|3.27||0.47|TWO_SIDED|95.0|-8.77|4.07||The a priori threshold for statistical significance was \<0.025 to account for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||4.07|-8.77|0.47
70943355|NCT01177137|141387085|SUPERIORITY||Slope|-2.8|STANDARD_ERROR_OF_MEAN|2.78||0.31|TWO_SIDED|95.0|-8.27|2.65||The a priori threshold for statistical significance was \<0.025 to account for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||2.65|-8.27|0.31
70943356|NCT01177137|141387086|SUPERIORITY||Slope|-0.14|STANDARD_ERROR_OF_MEAN|2.63||0.96|TWO_SIDED|95.0|-5.3|5.02||The a priori threshold for statistical significance was \<0.025 to account for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Ca|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||5.02|-5.30|0.96
70943357|NCT01177137|141387086|SUPERIORITY||Slope|2.74|STANDARD_ERROR_OF_MEAN|2.53||0.28|TWO_SIDED|95.0|-2.21|7.7||The a priori threshold for statistical significance was \<0.025 to adjust for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Ca|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||7.70|-2.21|0.28
70943358|NCT01177137|141387087|SUPERIORITY||Slope|0.61|STANDARD_ERROR_OF_MEAN|0.59||0.3|TWO_SIDED|95.0|-0.55|1.77||The a priori threshold for statistical significance was \<0.025 to account for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||1.77|-0.55|0.30
70943359|NCT01177137|141387087|SUPERIORITY||Slope|-0.62|STANDARD_ERROR_OF_MEAN|0.58||0.29|TWO_SIDED|95.0|-1.75|0.52||The a priori threshold for statistical significance was \<0.025 to account for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Ca|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.52|-1.75|0.29
70943360|NCT01177137|141387089|SUPERIORITY||Slope|-0.39|STANDARD_ERROR_OF_MEAN|1.37||0.77|TWO_SIDED|95.0|-3.08|2.29||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||2.29|-3.08|0.77
70943361|NCT01177137|141387089|SUPERIORITY||Slope|-0.6|STANDARD_ERROR_OF_MEAN|1.3||0.65|TWO_SIDED|95.0|-3.16|1.96||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||1.96|-3.16|0.65
70954237|NCT00688870|141411076|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.75|||||TWO_SIDED|95.0|0.57|0.99|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 18C||0.99|0.57|
70871998|NCT03919799|141229341|SUPERIORITY||Least square mean difference|-21.984||||0.2922|TWO_SIDED|95.0|-63.93|19.962||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||19.962|-63.930|0.2922
70871999|NCT03919799|141229342|SUPERIORITY||Least square mean difference|-16.757||||0.532|TWO_SIDED|95.0|-70.933|37.419||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||37.419|-70.933|0.5320
70854806|NCT01332461|141198010|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.785|||<|0.05|TWO_SIDED|95.0|0.649|0.948||COPD-related hospitalization/ER visit/physician+Rx|Log Rank||Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.|||0.948|0.649|<0.05
70854807|NCT02660138|141198063|SUPERIORITY|If both p-values for the 2 primary tests (the test of Dysport® 800 U vs. placebo and the test of Dysport® 600 U vs. placebo) were lower than 0.05, both were declared statistically significant. If 1 of the primary tests had a p-value greater than or equal to 0.05, then the other test was declared statistically significant if its p-value was lower than 0.025.|LS Mean Difference|-10.83||||0.0001|TWO_SIDED|95.0|-16.36|-5.31|||MMRM|||Treatment group, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[Botulinum toxin \[BTX\]-naïve or BTX-non-naïve\]) and study baseline value (weekly number of UI episodes) as fixed effect variables, and subject as a random effect.||-5.31|-16.36|0.0001
71080192|NCT02757352|141667117|SUPERIORITY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.602||0.11|TWO_SIDED|95.0|-2.15|0.22|||Mixed Models Analysis|||||0.22|-2.15|0.110
71080193|NCT02757352|141667118|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.81||0.348|TWO_SIDED|95.0|-2.4|0.8|||Mixed Models Analysis|||||0.8|-2.4|0.348
71080194|NCT02757352|141667118|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.82||0.386|TWO_SIDED|95.0|-2.3|0.9|||Mixed Models Analysis|||||0.9|-2.3|0.386
71080195|NCT02757352|141667119|SUPERIORITY||LS Mean Difference|-13.76|STANDARD_ERROR_OF_MEAN|4.835||0.005|TWO_SIDED|95.0|-23.32|-4.2|||ANCOVA|||Overall Impairment Score||-4.20|-23.32|0.005
70854808|NCT02660138|141198063|SUPERIORITY|If both p-values for the 2 primary tests (the test of Dysport® 800 U vs. placebo and the test of Dysport® 600 U vs. placebo) were lower than 0.05, both were declared statistically significant. If 1 of the primary tests had a p-value greater than or equal to 0.05, then the other test was declared statistically significant if its p-value was lower than 0.025.|LS Mean Difference|-12.19|||<|0.0001|TWO_SIDED|95.0|-17.65|-6.73|||MMRM|||Treatment group, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (weekly number of UI episodes) as fixed effect variables, and subject as a random effect.||-6.73|-17.65|<0.0001
70872000|NCT03919799|141229342|SUPERIORITY||Least square mean difference|4.02||||0.8804|TWO_SIDED|95.0|-50.156|58.196||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||58.196|-50.156|0.8804
71080196|NCT02757352|141667119|SUPERIORITY||LS Mean Difference|-6.29|STANDARD_ERROR_OF_MEAN|4.697||0.183|TWO_SIDED|95.0|-15.58|3.0|||ANCOVA|||Overall Impairment Score||3.00|-15.58|0.183
70872001|NCT03919799|141229343|SUPERIORITY||Least square mean difference|7.522||||0.8628|TWO_SIDED|95.0|-80.837|95.88||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||95.880|-80.837|0.8628
70854809|NCT02660138|141198064|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|160.9|||<|0.0001|TWO_SIDED|95.0|109.9|211.9|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and baseline value of MCC as covariates.||211.9|109.9|<0.0001
70854810|NCT02660138|141198064|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|189.2|||<|0.0001|TWO_SIDED|95.0|140.1|238.2|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and baseline value of MCC as covariates.||238.2|140.1|<0.0001
70854811|NCT02660138|141198065|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|-24.3|||<|0.0001|TWO_SIDED|95.0|-32.3|-16.4|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and baseline value of MDP as covariates.||-16.4|-32.3|<0.0001
70854812|NCT02660138|141198065|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|-28.6|||<|0.0001|TWO_SIDED|95.0|-36.2|-21.1|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and baseline value of MDP as covariates.||-21.1|-36.2|<0.0001
70854813|NCT02660138|141198066|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|155.5|||<|0.0001|TWO_SIDED|95.0|100.5|210.4|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and baseline value of Vol@1stIDC as covariates.||210.4|100.5|<0.0001
70854814|NCT02660138|141198066|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|181.8|||<|0.0001|TWO_SIDED|95.0|129.2|234.3|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and baseline value of Vol@1stIDC as covariates.||234.3|129.2|<0.0001
71118772|NCT01730339|141742336|SUPERIORITY_OR_OTHER||Least Square mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.11|0.4||||||Participant: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.40|-0.11|
71118773|NCT01962987|141742398|EQUIVALENCE|90% confidence interval of the difference in the percentage of patients between Test and Reference to be contained within -20%, + 20%, using the Per-Protocol Population.|(Test-Ref) Difference|0.68|||||TWO_SIDED|90.0|-8.06|9.42|||||Applicable to Percentage of Subjects with Cure (100% complete AK clearance at day 90)|||9.42|-8.06|
71118774|NCT01962987|141742398|SUPERIORITY|||||||0.001|||||||ANOVA|||||||0.0010
71118775|NCT02688088|141742417|SUPERIORITY||Ratio of Geometric LS Means|1.01|||||TWO_SIDED|90.0|0.965|1.06||||||||1.06|0.965|
71118776|NCT02688088|141742418|SUPERIORITY||Ratio of Geometric LS Means|0.935|||||TWO_SIDED|90.0|0.871|1.0||||||||1.00|0.871|
71118777|NCT02688088|141742419|SUPERIORITY||Ratio of Geometric LS Means|1.05|||||TWO_SIDED|90.0|0.898|1.22||||||||1.22|0.898|
71118778|NCT02688088|141742420|SUPERIORITY||Ratio of Geometric LS Means|0.845|||||TWO_SIDED|90.0|0.76|0.94||||||||0.940|0.760|
71118779|NCT02688088|141742421|SUPERIORITY||Ratio of Geometric LS Means|1.56|||||TWO_SIDED|90.0|1.35|1.81||||||||1.81|1.35|
71118780|NCT02688088|141742422|SUPERIORITY||Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|0.956|1.13||||||||1.13|0.956|
71118781|NCT02688088|141742423|SUPERIORITY||Mean Difference (Final Values)|0.976|||||TWO_SIDED|90.0|0.805|1.18||||||||1.18|0.805|
71118782|NCT02688088|141742424|SUPERIORITY||Ratio of Geometric LS Means|0.867|||||TWO_SIDED|90.0|0.775|0.972||||||||0.972|0.775|
71118783|NCT02449889|141742438|NON_INFERIORITY|Treatment comparisons were done in a sequential manner. First non-inferiority (NI) was tested for HP-hCG IM compared to rhCG SC (lower limit of the 95% confidence interval (CI) \> -3.0). If NI was demonstrated, NI was also to be tested for HP-hCG SC compared to rhCG SC.|Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.6|1.8|||||ANOVA with treatment, stratum (\<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Mean number of oocytes retrieved for the treatment comparison of HP-hCG IM versus rhCG SC||1.8|-0.6|
71118784|NCT02449889|141742438|NON_INFERIORITY|As step 2 in the pre-specified sequential testing, NI was tested for HP-hCG SC compared to rhCG SC.|Mean Difference (Final Values)|0.8|||||TWO_SIDED|95.0|-0.5|2.0|||||ANOVA with treatment, stratum (\<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Mean number of oocytes retrieved for the treatment comparison of HP-hCG SC versus rhCG SC||2.0|-0.5|
71118785|NCT02449889|141742439|NON_INFERIORITY|Pre-specified supportive endpoint analyzed in a similar manner as the primary endpoint.|Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.6|1.5|||||ANOVA with treatment, stratum (\<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Number of MII oocytes retrieved for the treatment comparison of HP-hCG IM versus rhCG SC||1.5|-0.6|
71118786|NCT02449889|141742439|NON_INFERIORITY|Pre-specified supportive endpoint analyzed in a similar manner as the primary endpoint.|Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.4|1.6|||||ANOVA with treatment, stratum (\<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Number of Mll oocytes retrieved for the treatment comparison of HP-hCG SC versus rhCG SC||1.6|-0.4|
71118787|NCT02449889|141742440|NON_INFERIORITY|Pre-specified supportive endpoint analyzed in a similar manner as the primary endpoint.|Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.6|1.3|||||ANOVA with treatment, stratum (\<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Number of fertilized (2 pronuclei (2PN)) oocytes for the treatment comparison of HP-hCG IM versus rhCG SC||1.3|-0.6|
71118788|NCT02449889|141742440|NON_INFERIORITY|Pre-specified supportive endpoint analyzed in a similar manner as the primary endpoint.|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-0.5|1.4|||||ANOVA with treatment, stratum (\<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Number of fertilized (2 pronuclei (2PN)) oocytes for the treatment comparison of HP-hCG SC versus rhCG SC.||1.4|-0.5|
70943362|NCT01177137|141387090|SUPERIORITY||Slope|-0.36|STANDARD_ERROR_OF_MEAN|0.52||0.5|TWO_SIDED|95.0|-1.38|0.67||The a priori threshold for statistical significance was set at \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.67|-1.38|0.50
70954238|NCT00688870|141411076|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|1.09|||||TWO_SIDED|95.0|0.83|1.43|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 19F||1.43|0.83|
70872002|NCT03919799|141229343|SUPERIORITY||Least square mean difference|-42.442||||0.3196|TWO_SIDED|95.0|-128.242|43.359|||MMRM|||Belumosudil 200 mg BID versus Placebo||43.359|-128.242|0.3196
70943363|NCT01177137|141387090|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.52||0.82|TWO_SIDED|95.0|-1.14|0.9||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.90|-1.14|0.82
71080197|NCT02757352|141667119|SUPERIORITY||LS Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|3.114||0.06|TWO_SIDED|95.0|-12.05|0.26|||ANCOVA|||Percentage of absenteeism||0.26|-12.05|0.060
71118789|NCT03077438|141742507|NON_INFERIORITY|95% confidence interval (CI) of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|7.6|||||TWO_SIDED|95.0|1.1|14.0||||||Serogroup A||14|1.1|
71118790|NCT03077438|141742507|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|47.4|||||TWO_SIDED|95.0|42.2|52.2||||||Serogroup C||52.2|42.2|
71118791|NCT03077438|141742507|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|12.2|||||TWO_SIDED|95.0|7.7|16.7||||||Serogroup Y||16.7|7.7|
71118792|NCT03077438|141742507|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|14.8|||||TWO_SIDED|95.0|8.9|20.5||||||Serogroup W||20.5|8.9|
71118793|NCT03077438|141742508|OTHER||GMT Ratio|1.09|||||TWO_SIDED|95.0|0.91|1.32||||||Serogroup A||1.32|0.91|
71118794|NCT03077438|141742508|OTHER||GMT Ratio|14.0|||||TWO_SIDED|95.0|11.3|17.3||||||Serogroup C||17.3|11.3|
71118795|NCT03077438|141742508|OTHER||GMT Ratio|1.58|||||TWO_SIDED|95.0|1.31|1.9||||||Serogroup Y||1.9|1.31|
71118796|NCT03077438|141742508|OTHER||GMT Ratio|1.43|||||TWO_SIDED|95.0|1.21|1.69||||||Serogroup W||1.69|1.21|
71118797|NCT03077438|141742509|OTHER||GMT Ratio|1.14|||||TWO_SIDED|95.0|0.883|1.47||||||Serogroup A||1.47|0.883|
71118798|NCT03077438|141742509|OTHER||GMT Ratio|17.4|||||TWO_SIDED|95.0|13.4|22.6||||||Serogroup C||22.6|13.4|
71118799|NCT03077438|141742509|OTHER||GMT Ratio|1.38|||||TWO_SIDED|95.0|1.07|1.78||||||Serogroup Y||1.78|1.07|
71118800|NCT03077438|141742509|OTHER||GMT Ratio|1.43|||||TWO_SIDED|95.0|1.12|1.83||||||Serogroup W||1.83|1.12|
71118801|NCT03077438|141742510|OTHER||GMT Ratio|1.06|||||TWO_SIDED|95.0|0.816|1.38||||||Serogroup A||1.38|0.816|
71118802|NCT03077438|141742510|OTHER||GMT Ratio|11.5|||||TWO_SIDED|95.0|8.24|16.0||||||Serogroup C||16|8.24|
70954239|NCT00688870|141411076|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.69|||||TWO_SIDED|95.0|0.52|0.92|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 23F||0.92|0.52|
71118803|NCT03077438|141742510|OTHER||GMT Ratio|1.84|||||TWO_SIDED|95.0|1.41|2.38||||||Serogroup Y||2.38|1.41|
71118804|NCT03077438|141742510|OTHER||GMT Ratio|1.45|||||TWO_SIDED|95.0|1.16|1.82||||||Serogroup W||1.82|1.16|
71118805|NCT03077438|141742511|OTHER||Percentage Difference|7.6|||||TWO_SIDED|95.0|-1.6|16.7||||||Serogroup A||16.7|-1.6|
71118806|NCT03077438|141742511|OTHER||Percentage Difference|51.1|||||TWO_SIDED|95.0|43.5|57.8||||||Serogroup C||57.8|43.5|
71118807|NCT03077438|141742511|OTHER||Percentage Difference|11.2|||||TWO_SIDED|95.0|4.2|18.1||||||Serogroup Y||18.1|4.2|
71118808|NCT03077438|141742511|OTHER||Percentage Difference|12.5|||||TWO_SIDED|95.0|3.9|20.9||||||Serogroup W||20.9|3.9|
71118809|NCT03077438|141742512|OTHER||Percentage Difference|7.7|||||TWO_SIDED|95.0|-1.3|16.6||||||Serogroup A||16.6|-1.3|
71118810|NCT03077438|141742512|OTHER||Percentage Difference|44.0|||||TWO_SIDED|95.0|36.8|50.6||||||Serogroup C||50.6|36.8|
71118811|NCT03077438|141742512|OTHER||Percentage Difference|13.3|||||TWO_SIDED|95.0|7.6|19.2||||||Serogroup Y||19.2|7.6|
71118812|NCT03077438|141742512|OTHER||Percentage Difference|17.2|||||TWO_SIDED|95.0|9.4|24.7||||||Serogroup W||24.7|9.4|
71118813|NCT00385944|141742529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.91|||<|0.001|TWO_SIDED|95.0|-17.02|-8.81|||Mixed Models Analysis|||||-8.81|-17.02|<0.001
71118814|NCT00385944|141742530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.81|||<|0.001|TWO_SIDED|95.0|-10.96|-4.65|||Mixed Models Analysis|||||-4.65|-10.96|<0.001
71118815|NCT00385944|141742531|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.98|||<|0.001|TWO_SIDED|95.0|-17.06|-6.9|||Mixed Models Analysis|||||-6.90|-17.06|<0.001
71118816|NCT00385944|141742532|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.3||||0.001|TWO_SIDED|95.0|-6.84|-1.76|||Mixed Models Analysis|||||-1.76|-6.84|0.001
71118817|NCT00385944|141742533|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.16|||<|0.001|TWO_SIDED|95.0|7.05|23.26|||Mixed Models Analysis|||||23.26|7.05|<0.001
71118818|NCT00385944|141742534|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.69||||0.001|TWO_SIDED|95.0|5.56|19.81|||Mixed Models Analysis|||||19.81|5.56|0.001
71118819|NCT00385944|141742535|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.26||||0.015|TWO_SIDED|95.0|2.17|18.34|||Mixed Models Analysis|||||18.34|2.17|0.015
71118820|NCT00385944|141742536|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.85||||0.123|TWO_SIDED|95.0|-1.13|8.84|||Mixed Models Analysis|||||8.84|-1.13|0.123
71118821|NCT00385944|141742537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.83|||<|0.001|TWO_SIDED|95.0|-23.05|-10.62|||Mixed Models Analysis|||||-10.62|-23.05|<0.001
71118822|NCT00385944|141742538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-54.44|||<|0.001|TWO_SIDED|95.0|-70.87|-38.01|||Mixed Models Analysis|||||-38.01|-70.87|<0.001
71118823|NCT00385944|141742540|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-35.5|||<|0.001||95.0|||||two-sided paired t-test|||||||<.001
71118824|NCT00385944|141742541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.0||||0.011||95.0|||||two-sided paired t-test|||Paired t-test for each arm separately||||0.011
71118825|NCT00385944|141742541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.847||95.0|||||two-sided paired t-test|||Paired t-test for each arm separately||||0.847
71118826|NCT00385944|141742542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.24||||0.008|TWO_SIDED|95.0|-15.99|-2.49|||t-test, 2 sided|||||-2.49|-15.99|0.008
71118827|NCT00385944|141742543|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.52|||<|0.001|TWO_SIDED|95.0|9.22|25.83|||t-test, 2 sided|||||25.83|9.22|<0.001
71118828|NCT00834990|141742563|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|103.41||||||90.0|97.13|110.08|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||110.08|97.13|
71080198|NCT02757352|141667119|SUPERIORITY||LS Mean Difference|-4.15|STANDARD_ERROR_OF_MEAN|3.098||0.182|TWO_SIDED|95.0|-10.27|1.97|||ANCOVA|||Percentage of absenteeism||1.97|-10.27|0.182
70954240|NCT00688870|141411076|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|303.73|||||TWO_SIDED|95.0|213.63|431.83|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 1||431.83|213.63|
71118829|NCT00834990|141742564|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|101.68||||||90.0|96.79|106.83|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106.83|96.79|
71118830|NCT00834990|141742565|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|103.17||||||90.0|98.5|108.05|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.05|98.5|
71118831|NCT00791479|141742572|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||<0.001
71118832|NCT00791479|141742572|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||<0.001
71118833|NCT00791479|141742572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.069||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||0.069
71118834|NCT00791479|141742572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
71118835|NCT00791479|141742572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
71118836|NCT00791479|141742572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
71118837|NCT00791479|141742573|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 4. A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||<0.001
71118838|NCT00791479|141742573|SUPERIORITY_OR_OTHER|||||||0.023||||||Treatment comparison at Week 4. A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||0.023
71118839|NCT00791479|141742573|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 8. A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||<0.001
71118840|NCT00791479|141742573|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 8. A priori threshold for statistical significance was P\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||<0.001
71118841|NCT00791479|141742574|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||<0.001
71118842|NCT00791479|141742574|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||<0.001
71118843|NCT00791479|141742574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.81||||0.456||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||0.456
71118844|NCT00791479|141742574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.53|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
71118845|NCT00791479|141742574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.96|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
71118846|NCT00791479|141742574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.71|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
71118847|NCT00791479|141742575|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of glycosylated hemoglobin (HbA1c) levels \<7.0%.|Cochran-Armitage trend test|The Cochran-Armitage trend test included the placebo arm.||||||<0.001
71118848|NCT00791479|141742575|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of glycosylated hemoglobin (HbA1c) levels ≤6.5%.|Cochran-Armitage trend test|The Cochran-Armitage trend test included the placebo arm.||||||<0.001
71118849|NCT00791479|141742576|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||<0.001
71118850|NCT00791479|141742576|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||<0.001
71118851|NCT00791479|141742576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.65||||0.378||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||0.378
71118852|NCT00791479|141742576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.09|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
71118853|NCT00791479|141742576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.34|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
71118854|NCT00791479|141742576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-38.67|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
71118855|NCT00791479|141742577|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||<0.001
70943364|NCT01177137|141387091|SUPERIORITY||Slope|-0.38|STANDARD_ERROR_OF_MEAN|0.51||0.46|TWO_SIDED|95.0|-1.37|0.62||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation.|||0.62|-1.37|0.46
70943365|NCT01177137|141387091|SUPERIORITY|The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|Slope|-0.36|STANDARD_ERROR_OF_MEAN|0.51||0.48|TWO_SIDED|95.0|-1.35|0.64|||repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.64|-1.35|0.48
71080199|NCT02757352|141667119|SUPERIORITY||LS Mean Difference|-13.61|STANDARD_ERROR_OF_MEAN|4.558||0.003|TWO_SIDED|95.0|-22.62|-4.6|||ANCOVA|||Percentage of presentism||-4.60|-22.62|0.003
71080200|NCT02757352|141667119|SUPERIORITY||LS Mean Difference|-6.21|STANDARD_ERROR_OF_MEAN|4.446||0.164|TWO_SIDED|95.0|-15.0|2.58|||ANCOVA|||Percentage of presentism||2.58|-15.00|0.164
71080201|NCT02757352|141667119|SUPERIORITY||LS Mean Difference|-10.63|STANDARD_ERROR_OF_MEAN|3.669||0.004|TWO_SIDED|95.0|-17.85|-3.41|||LS Mean Difference|||Percentage of Impairment in Activities Performed Outside of Work||-3.41|-17.85|0.004
71080202|NCT02757352|141667119|SUPERIORITY||LS Mean Difference|-9.99|STANDARD_ERROR_OF_MEAN|3.621||0.006|TWO_SIDED|95.0|-17.12|-2.86|||ANCOVA|||Percentage of Impairment in Activities Performed Outside of Work||-2.86|-17.12|0.006
71118856|NCT00791479|141742577|SUPERIORITY_OR_OTHER|||||||0.036||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||0.036
71118857|NCT00791479|141742578|SUPERIORITY_OR_OTHER|||||||0.45||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||0.450
71118858|NCT00791479|141742578|SUPERIORITY_OR_OTHER|||||||0.329||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||0.329
71118859|NCT00791479|141742586|SUPERIORITY_OR_OTHER|||||||0.969||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||0.969
71118860|NCT00791479|141742586|SUPERIORITY_OR_OTHER|||||||0.009||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||0.009
71118861|NCT00791479|141742586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.19||||0.14||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||0.140
71118862|NCT00791479|141742586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04||||0.247||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||0.247
71118863|NCT00791479|141742586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.975||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||0.975
71118864|NCT00791479|141742586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||1||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||1.00
71118865|NCT01778049|141742589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.1||0.0013||95.0|-0.52|-0.13|||Mixed Model Repeated Measure (MMRM)|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the adjusted mean difference calculated as lina5 (E10) minus Plc (E10) value.|Superiority of lina5 (E10) vs. Plc (E10): change in HbA1c using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. The model includes baseline HbA1c as linear covariates \& baseline estimated glomerula filtration rate (eGFR), geographical region, treatment, visit, visit by treatment interaction as fixed effects.||-0.13|-0.52|0.0013
71118866|NCT01778049|141742589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.66|-0.28|||MMRM|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the adjusted mean difference value calculated as lina5 (E25) minus Plc (E25).|Superiority of lina5 (E25) vs. Plc (E25): change in HbA1c using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. The model includes baseline HbA1c as linear covariates \& baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effects.||-0.28|-0.66|<0.0001
71118867|NCT01778049|141742590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.25||0.0103||95.0|-1.15|-0.16|||MMRM|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the adjusted mean difference value calculated as lina5 (E10) minus Plc (E10).|Superiority of lina5 (E10) vs. Plc (E10): change in FPG using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. The model includes baseline HbA1c \& baseline eGFR as linear covariates, geographical region, treatment, visit, visit by treatment interaction as fixed effects.||-0.16|-1.15|0.0103
71118868|NCT01778049|141742590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.22||0.0452||95.0|-0.87|-0.01|||MMRM|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the adjusted mean difference value calculated as lina5 (E25) minus Plc (E25).|Superiority of lina5 (E25) vs. Plc (E25): change in FPG using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. The model includes baseline HbA1c \& baseline eGFR as linear covariates, geographical region, treatment, visit, visit by treatment interaction as fixed effects.||-0.01|-0.87|0.0452
71118869|NCT02379988|141742602|EQUIVALENCE|The wilcoxon paired signed rank test was used as the primary analysis because of the non-normal distributions|||||=|0.0063||||||P-value for Free breathing and Breath Holding Heart Mean|Wilcoxon (Mann-Whitney)|||||||=0.0063
71118870|NCT02379988|141742602|EQUIVALENCE|The wilcoxon paired signed rank test was used as the primary analysis because of the non-normal distributions.|||||=|0.011||||||P-value for Free breathing and Breath Holding Lung Mean|Wilcoxon (Mann-Whitney)|||||||=0 .0110
71118871|NCT02379988|141742602|EQUIVALENCE|The wilcoxon paired signed rank test was used as the primary analysis because of the non-normal distributions.|||||=|0.5098||||||P-value for Free breathing and Breath Holding LAD Mean|Wilcoxon (Mann-Whitney)|||||||=0.5098
71118872|NCT02379988|141742603|EQUIVALENCE|The wilcoxon paired signed rank test was used as the primary analysis because of the non-normal distributions|||||=|0.001||||||P-value for Heart Max Free breathing and Breath Hold|Wilcoxon (Mann-Whitney)|||||||=0.0010
71118873|NCT02379988|141742603|EQUIVALENCE|The wilcoxon paired signed rank test was used as the primary analysis because of the non-normal distributions.|||||=|0.011||||||P-value for Lung Max Free breathing and Breath Hold|Wilcoxon (Mann-Whitney)|||||||=0.0110
71118874|NCT02379988|141742604|EQUIVALENCE|Paired T-test|||||=|0.01||||||P-value for Large breast volume group|Paired T-test|||||||=0.01
71118875|NCT02379988|141742604|EQUIVALENCE|Paired T-test|||||=|0.1||||||P-value for Small breast volume group|Paired T-test|||||||=0.10
71118876|NCT02379988|141742605|EQUIVALENCE|Wilcoxon test was used due to the non-normal distribution of the data|||||=|0.7776|||||||Wilcoxon (Mann-Whitney)|||||||=0.7776
71118877|NCT02089464|141742669|SUPERIORITY|||||||0.76|||||||Chi-squared|||||||0.76
71118878|NCT02089464|141742670|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.80
71118879|NCT02089464|141742671|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
71118880|NCT02089464|141742672|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
71118881|NCT02089464|141742673|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
71118882|NCT02089464|141742675|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||||||0.95
71118883|NCT02089464|141742676|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.96
71118884|NCT02089464|141742677|SUPERIORITY|||||||0.63|||||||Chi-squared|||||||0.63
71118885|NCT00934947|141742695|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||.36
71118886|NCT00934947|141742696|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||||||.32
71118887|NCT00934947|141742697|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||||||.48
71118888|NCT01907321|141742698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.78|STANDARD_DEVIATION|14.98||0.001|TWO_SIDED||||||repeated measures ANOVA|||||||.001
71118889|NCT01907321|141742699|SUPERIORITY_OR_OTHER|||||||0.519|||||||ANOVA|||||||.519
71118890|NCT04049266|141742706|NON_INFERIORITY|The maximum clinically acceptable true difference between KSI-301 and aflibercept participants to be considered non-inferior is 4 ETDRS letters, i.e. the non-inferiority margin (NI) is 4 letters.|Adjusted mean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.01|>|0.9999|TWO_SIDED|95.03|-8.0|-4.0|||Mixed Models Analysis|MMRM model with treatment, visit, treatment by visit interaction, categories for baseline BCVA, BCVA-low luminance VA baseline, geographical location.||||-4|-8|> 0.9999
71118891|NCT01703208|141742714|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.77|1.29|||||Based on the proportional hazards model that includes treatment as an explanatory factor.|||1.29|0.77|
71118892|NCT01703208|141742715|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.43|||||TWO_SIDED|95.0|-0.48|-0.37||||||||-0.37|-0.48|
71118893|NCT01703208|141742716|SUPERIORITY_OR_OTHER||Difference in the LS Means vs Placebo|-0.39|||<|0.001|TWO_SIDED|95.0|-0.5|-0.27|||Longitudinal data analysis|Longitudinal data analysis model including terms for treatment, time and the interaction of time by treatment.||||-0.27|-0.50|<0.001
71118894|NCT01703208|141742717|SUPERIORITY_OR_OTHER||Difference in Percent vs. Placebo|-1.1|||||TWO_SIDED|95.0|-7.2|4.9|||||Based on Miettinen \& Nurminen method. The 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.|||4.9|-7.2|
71118895|NCT01703208|141742718|SUPERIORITY_OR_OTHER||Difference in Percentage vs. Placebo|0.3|||||TWO_SIDED|95.0|-1.0|1.7|||||Based on Miettinen \& Nurminen method. The 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.|||1.7|-1.0|
71118896|NCT01703208|141742720|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.66|1.68|||||Based on the proportional hazards model that includes treatment as an explanatory factor.|||1.68|0.66|
71118897|NCT01703208|141742722|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.6|1.26|||||Based on the proportional hazards model that includes treatment as an explanatory factor.|||1.26|0.60|
71118898|NCT01703208|141742724|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.58|1.52|||||Based on the proportional hazards model that includes treatment as an explanatory factor.|||1.52|0.58|
71118899|NCT01703208|141742726|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.28|||||TWO_SIDED|95.0|0.88|1.85|||||Based on the proportional hazards model that includes treatment as an explanatory factor.|||1.85|0.88|
71118900|NCT01703208|141742727|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.3|||||TWO_SIDED|95.0|-0.46|-0.14|||||Longitudinal Data Analysis (LDA) model including terms for treatment, time, and the interaction of time by treatment.|||-0.14|-0.46|
71118901|NCT01703208|141742733|SUPERIORITY_OR_OTHER||Difference in the least squares means|-3.1||||0.421|TWO_SIDED|95.0|-10.8|4.5|||Longitudinal constrained data analysis||Based on a LDA model including terms for treatment, time and the interaction of time by treatment.|||4.5|-10.8|0.421
71118902|NCT01703208|141742734|SUPERIORITY_OR_OTHER||Between group rate difference|11.9|||<|0.001|TWO_SIDED|95.0|6.9|16.8||Estimated using standard multiple imputation techniques.|Miettinen & Nurminen method|||||16.8|6.9|<0.001
71118903|NCT01703208|141742736|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.35|1.05|||||Based on the proportional hazards model that includes treatment as an explanatory factor.|||1.05|0.35|
71118904|NCT04699032|141742750|OTHER|Analysis of variance (ANOVA) was used to compare the natural log transformed Cmax for apraglutide between normal renal function group (Reference) and the severe impaired renal group (Test). Estimates of the mean differences and corresponding 90% confidence intervals (CIs) were obtained from the model. The mean differences and 90% CIs for the mean differences were exponentiated to provide estimates of the geometric least-square mean ratio (Test/Reference) and 90% CIs for the ratios.|Geometric least-square mean ratio|0.62|||||TWO_SIDED|90.0|0.423|0.909||||||||0.909|0.423|
70943366|NCT01177137|141387092|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.32||0.75|TWO_SIDED|95.0|-0.74|0.53||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.53|-0.74|0.75
70943367|NCT01177137|141387092|SUPERIORITY||Slope|-0.87|STANDARD_ERROR_OF_MEAN|0.35||0.015|TWO_SIDED|95.0|-1.56|-0.17||The a priori threshold for statistical significance was \< 0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||-0.17|-1.56|0.015
70943368|NCT01177137|141387093|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.39||0.85|TWO_SIDED|95.0|-0.83|0.69||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.69|-0.83|0.85
70954241|NCT00688870|141411076|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|10.65|||||TWO_SIDED|95.0|7.77|14.62|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 3||14.62|7.77|
71080203|NCT02362425|141667144|SUPERIORITY|An a priori power calculation, with power at 80% and a two-sided α of 0·05, determined that n=76 participants (n=38 per group) would be required to detect a statistically significant post-intervention difference in plasma glutathione (GSH) concentration between NAC and placebo groups. After the primary endpoint was changed, re-evaluation of the sample size determined that a larger sample (total n=182) would be required. As per protocol, the study was completed at this time.|Mean Difference (Final Values)|0.1||||0.88|TWO_SIDED|95.0|-1.4|1.6|||Regression, Linear|Model comparing 12 m corrected 15-F2t-isoprostane conc. controlling for pre-intervention value. Investigated covariates: smoking and drinking status.||Null Hypothesis: In RYR1-RM myopathy patients, there will be no statistically significant difference in corrected 15-F2t-isoprostane concentration and/or corrected 15=f2t-Isop:PGR2alpha ratio between NAC and placebo groups at month 12, after controlling for established a priori confounders.||1.6|-1.4|0.88
71080204|NCT02362425|141667145|SUPERIORITY||Mean Difference (Final Values)|23.9||||0.11|TWO_SIDED|95.0|-5.5|53.4||Model controlled for six-month(pre-intervention) distance and treatment group. Investigated covariates: height|Regression, Linear|||In RYR1-RM myopathy patients, there will be no statistically significant difference in 6MWT (six minute walk test) total distance between NAC and placebo groups at month 12, after controlling for established a priori confounders.||53.4|-5.5|.11
71080205|NCT02362425|141667146|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.14|TWO_SIDED|95.0|-3.6|0.7|||Regression, Linear|||||0.7|-3.6|0.14
71080206|NCT02362425|141667147|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.62|TWO_SIDED|95.0|-0.5|0.3|||t-test, 2 sided|||||0.3|-0.5|0.62
71080207|NCT02362425|141667148|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.05|TWO_SIDED|95.0|-1.1|0.0|||t-test, 2 sided|||||0.0|-1.1|0.05
71080208|NCT02362425|141667149|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.25|TWO_SIDED|95.0|-2.1|0.6|||t-test, 2 sided|||||0.6|-2.1|0.25
71080209|NCT02362425|141667150|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.05|TWO_SIDED|95.0|-2.1|0.0|||t-test, 2 sided|||||0.0|-2.1|0.05
71080210|NCT02362425|141667151|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.09|TWO_SIDED|95.0|-0.6|7.3|||t-test, 2 sided|||||7.3|-0.6|0.09
71080211|NCT02362425|141667152|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.69|TWO_SIDED|95.0|-1.3|2.0|||t-test, 2 sided|||||2.0|-1.3|0.69
71080212|NCT02362425|141667153|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.31|TWO_SIDED|95.0|-3.5|1.1|||t-test, 2 sided|||||1.1|-3.5|0.31
71080213|NCT02362425|141667154|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.22|TWO_SIDED|95.0|-0.8|3.0|||t-test, 2 sided|||||3.0|-0.8|0.22
71080214|NCT02362425|141667155|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.93|TWO_SIDED|95.0|-2.6|2.4|||t-test, 2 sided|||||2.4|-2.6|0.93
71080215|NCT02362425|141667156|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.66|TWO_SIDED|95.0|-1.3|0.8|||t-test, 2 sided|||||0.8|-1.3|0.66
71080216|NCT02362425|141667157|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.09|TWO_SIDED|95.0|-0.4|4.6|||t-test, 2 sided|||||4.6|-0.4|0.09
71080217|NCT02362425|141667158|SUPERIORITY||Mean Difference (Final Values)|4.2||||0.09|TWO_SIDED|95.0|-0.7|9.0|||t-test, 2 sided|||||9.0|-0.7|0.09
71080218|NCT02362425|141667159|SUPERIORITY||Mean Difference (Final Values)|-5.5||||0.15|TWO_SIDED|95.0|-13.4|2.4|||t-test, 2 sided|||||2.4|-13.4|0.15
71080219|NCT02362425|141667160|SUPERIORITY||Mean Difference (Final Values)|-6.4||||0.08|TWO_SIDED|95.0|-13.7|1.0|||t-test, 2 sided|||||1.0|-13.7|0.08
71080220|NCT02362425|141667161|SUPERIORITY||Mean Difference (Final Values)|-16.27||||0.39|TWO_SIDED|95.0|-80.1|47.5|||t-test, 2 sided|||||47.5|-80.1|0.39
71080221|NCT02362425|141667162|SUPERIORITY||Mean Difference (Final Values)|10.0||||0.57|TWO_SIDED|95.0|-59.5|39.5|||t-test, 2 sided|||||39.5|-59.5|0.57
71080222|NCT02362425|141667163|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.12|TWO_SIDED|95.0|-5.0|0.6|||t-test, 2 sided|||||0.6|-5.0|0.12
71080223|NCT02362425|141667164|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.76|TWO_SIDED|95.0|-3.6|2.7|||t-test, 2 sided|||||2.7|-3.6|0.76
71080224|NCT02362425|141667165|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.72|TWO_SIDED|95.0|-2.5|3.5|||t-test, 2 sided|||||3.5|-2.5|0.72
71080225|NCT02362425|141667166|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.7|TWO_SIDED|95.0|-1.8|2.7|||t-test, 2 sided|||||2.7|-1.8|0.70
71080226|NCT02362425|141667167|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.88|TWO_SIDED|95.0|-2.8|3.3|||t-test, 2 sided|||||3.3|-2.8|0.88
71080227|NCT02362425|141667168|SUPERIORITY||Mean Difference (Final Values)|2.5||||0.61|TWO_SIDED|95.0|-10.3|15.2|||t-test, 2 sided|||||15.2|-10.3|0.61
71080228|NCT02362425|141667169|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.87|TWO_SIDED|95.0|-7.4|8.5|||t-test, 2 sided|||||8.5|-7.4|0.87
71080229|NCT02362425|141667170|SUPERIORITY||Mean Difference (Final Values)|-12.5||||0.28|TWO_SIDED|95.0|-38.9|13.9|||t-test, 2 sided|||||13.9|-38.9|0.28
71080230|NCT00802672|141667201|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For the primary efficacy analysis, a 90% confidence interval was constructed for the difference in the Therapeutic Success rates between the Test Product and Reference Product at Visit 4/Week 6 (Follow-Up). The interval was calculated using Wald's method with Yates' continuity correction. Therapeutic equivalence (bioequivalence) was established if this 90% confidence interval was contained within the interval -0.20 to +0.20 (-0.20% to +0.20%)|Mean Difference (Final Values)|1.0|||||TWO_SIDED|90.0|-17.61|2.45|||Wald's method with Yates' continuity|||||2.45|-17.61|
71080231|NCT02579382|141667211|SUPERIORITY||Least Squares Mean Difference|0.107||||0.227|TWO_SIDED|95.0|-0.067|0.282||MMRM model included treatment, baseline ALT level, HBeAg baseline status, baseline HBsAg, visit and treatment-by-visit interaction as fixed effect and visit as repeated measurement.|MMRM|||||0.282|-0.067|0.227
71080232|NCT02579382|141667211|SUPERIORITY||Least Squares Mean Difference|0.018||||0.84|TWO_SIDED|95.0|-0.156|0.191||MMRM model included treatment, baseline ALT level, HBeAg baseline status, baseline HBsAg, visit and treatment-by-visit interaction as fixed effect and visit as repeated measurement.|MMRM|||||0.191|-0.156|0.840
71080233|NCT02579382|141667211|SUPERIORITY||Least Squares Mean Difference|0.127||||0.151|TWO_SIDED|95.0|-0.047|0.301||MMRM model included treatment, baseline ALT level, HBeAg baseline status, baseline HBsAg, visit and treatment-by-visit interaction as fixed effect and visit as repeated measurement.|MMRM|||||0.301|-0.047|0.151
71080234|NCT03026283|141667236|OTHER|||||||1||||||In order to evaluate the significance of sensitivity and specificity findings, we implement McNemar's test comparing sensitivity and specificity for CCTA alone and FFR-CT, assuming conditional dependence.|Chi-squared|||Reference test is positive (test of sensitivity).||||1.00
71080235|NCT03026283|141667236|OTHER||||||<|0.0047||||||In order to evaluate the significance of sensitivity and specificity findings, we implement Mcnemar's test comparing sensitive and pscificity for CCTA and FFR-CT assuming dependence.|Chi-squared|McNemar's chi-squared = 8.00||Reference test is Negative||||<0.0047
71080236|NCT03782571|141667243|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|1.97|||TWO_SIDED|99.1|-4.0|7.4|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 1 - Control|Testing equivalence with respect to microsphere clearance rate.||7.4|-4.0|
71080237|NCT03782571|141667243|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|3.01|||TWO_SIDED|99.1|-4.0|13.4|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 2 - Control|Testing equivalence with respect to microsphere clearance rate.||13.4|-4.0|
71080238|NCT03782571|141667243|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|8.2|STANDARD_ERROR_OF_MEAN|3.78|||TWO_SIDED|99.1|-2.7|19.1|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 3 - Control|Testing equivalence with respect to microsphere clearance rate.||19.1|-2.7|
71080239|NCT03782571|141667243|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|6.5|STANDARD_ERROR_OF_MEAN|3.12|||TWO_SIDED|99.1|-2.6|15.5|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 3 - Test 1|Testing equivalence with respect to microsphere clearance rate.||15.5|-2.6|
70854815|NCT02660138|141198067|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|Odds Ratio (OR)|9.83||||0.0006|TWO_SIDED|95.0|2.72|35.6|||Generalised linear mixed model (GLMM)|||Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.||35.60|2.72|0.0006
70854816|NCT02660138|141198067|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|Odds Ratio (OR)|10.99||||0.0003|TWO_SIDED|95.0|3.05|39.61|||GLMM|||Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.||39.61|3.05|0.0003
70854817|NCT02660138|141198068|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|Odds Ratio (OR)|5.73||||0.001|TWO_SIDED|95.0|2.02|16.24|||Regression, Logistic|||Treatment group, and recorded stratification factors (aetiology of NDO, previous BTX-A usage) and study baseline (prior intradetrusor BTX-A usage for UI) as explanatory variables.||16.24|2.02|0.0010
70854818|NCT02660138|141198068|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|Odds Ratio (OR)|16.08|||<|0.0001|TWO_SIDED|95.0|5.82|44.43|||Regression, Logistic|||Treatment group, and recorded stratification factors (aetiology of NDO, previous BTX-A usage) and study baseline (prior intradetrusor BTX-A usage for UI) as explanatory variables.||44.43|5.82|<0.0001
70854819|NCT02660138|141198069|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|13.3||||0.0003|TWO_SIDED|95.0|6.22|20.37|||MMRM|||Treatment group, visit (Week 6 and Week 12), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (I-QoL summary total score) as fixed variables, and subject as a random effect.||20.37|6.22|0.0003
70854820|NCT02660138|141198069|SUPERIORITY|The secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|17.25|||<|0.0001|TWO_SIDED|95.0|10.36|24.15|||MMRM|||Treatment group, visit (Week 6 and Week 12), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (I-QoL summary total score) as fixed variables, and subject as a random effect.||24.15|10.36|<0.0001
70943369|NCT01177137|141387093|SUPERIORITY||Slope|-0.2|STANDARD_ERROR_OF_MEAN|0.34||0.55|TWO_SIDED|95.0|-0.86|0.46||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.46|-0.86|0.55
70943370|NCT01177137|141387094|SUPERIORITY||Slope|-3.19|STANDARD_ERROR_OF_MEAN|3.1||0.3|TWO_SIDED|95.0|-9.27|2.88||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||2.88|-9.27|0.30
71080240|NCT03782571|141667243|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|3.5|STANDARD_ERROR_OF_MEAN|1.88|||TWO_SIDED|99.1|-2.0|8.9|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 3 - Test 2|Testing equivalence with respect to microsphere clearance rate.||8.9|-2.0|
71080241|NCT03782571|141667243|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|99.1|-4.3|10.3|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 2 - Test 1|Testing equivalence with respect to microsphere clearance rate.||10.3|-4.3|
71080242|NCT03782571|141667244|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|8.4|STANDARD_ERROR_OF_MEAN|3.24|||TWO_SIDED|99.1|-1.0|17.8|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 1 - Control|Testing equivalence with respect to microsphere uptake rate.||17.8|-1.0|
71080243|NCT03782571|141667244|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|4.95|||TWO_SIDED|99.1|-7.8|20.9|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 2 - Control|Testing equivalence with respect to microsphere uptake rate.||20.9|-7.8|
71080244|NCT03782571|141667244|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|6.22|||TWO_SIDED|99.1|-15.1|20.9|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 3 - Control|Testing equivalence with respect to microsphere uptake rate.||20.9|-15.1|
71080245|NCT03782571|141667244|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|5.13|||TWO_SIDED|99.1|-20.4|9.4|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 3 - Test 1|Testing equivalence with respect to microsphere uptake rate.||9.4|-20.4|
71118905|NCT04699032|141742751|OTHER|ANOVA was used to compare the natural log transformed AUCinf for apraglutide between normal renal function group (Reference) and the severe impaired renal group (Test). Estimates of the mean differences and corresponding 90% CIs were obtained from the model. The mean differences and 90% CIs for the mean differences were exponentiated to provide estimates of the geometric least-square mean ratio (Test/Reference) and 90% CIs for the ratios.|Geometric least-square mean ratio|0.694|||||TWO_SIDED|90.0|0.458|1.05||||||||1.050|0.458|
70943371|NCT01177137|141387094|SUPERIORITY||Slope|-0.91|STANDARD_ERROR_OF_MEAN|2.98||0.76|TWO_SIDED|95.0|-6.75|4.93||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||4.93|-6.75|0.76
70943372|NCT01177137|141387095|SUPERIORITY||Slope|3.12|STANDARD_ERROR_OF_MEAN|3.34||0.35|TWO_SIDED|95.0|-3.44|9.68||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||9.68|-3.44|0.35
71118906|NCT02979093|141742762|SUPERIORITY||Mean Difference (Final Values)|0.1697|STANDARD_ERROR_OF_MEAN|0.1025||0.106|TWO_SIDED|||||Unadjusted|Mixed Models Analysis|||This analysis is for Striatum: Happy Own vs. Happy Unknown||||0.106
71118907|NCT02979093|141742762|SUPERIORITY||Mean Difference (Final Values)|0.20458|STANDARD_ERROR_OF_MEAN|0.1101||0.0709|TWO_SIDED|||||Unadjusted|Mixed Models Analysis|||This analysis is for the Amygdala: Happy Own vs. Happy Unknown infant faces.||||0.0709
71118908|NCT02979093|141742762|SUPERIORITY||Mean Difference (Final Values)|-0.14559|STANDARD_ERROR_OF_MEAN|0.08546||0.0964|TWO_SIDED|||||Unadjusted|Mixed Models Analysis|||This analysis is for Striatum: Sad Own vs. Sad Unknown infant faces.||||0.0964
71118909|NCT02979093|141742762|SUPERIORITY||Mean Difference (Final Values)|-0.15755|STANDARD_ERROR_OF_MEAN|0.07914||0.0538|TWO_SIDED|||||Unadjusted|Mixed Models Analysis|||This analysis is for Amygdala: Sad Own vs. Sad Unknown infant faces.||||0.0538
70943373|NCT01177137|141387095|SUPERIORITY||Slope|3.29|STANDARD_ERROR_OF_MEAN|3.19||0.3|TWO_SIDED|95.0|-2.96|9.54||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||9.54|-2.96|0.30
70943374|NCT01177137|141387096|SUPERIORITY||Slope|1.41|STANDARD_ERROR_OF_MEAN|3.37||0.68|TWO_SIDED|95.0|-5.2|8.02||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||8.02|-5.20|0.68
70943375|NCT01177137|141387096|SUPERIORITY||Slope|0.94|STANDARD_ERROR_OF_MEAN|3.26||0.77|TWO_SIDED|95.0|-5.44|7.33||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||7.33|-5.44|0.77
70943376|NCT01177137|141387097|SUPERIORITY||Slope|-3.53|STANDARD_ERROR_OF_MEAN|4.47||0.43|TWO_SIDED|95.0|-12.3|5.23||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||5.23|-12.30|0.43
71080246|NCT03782571|141667244|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|99.1|-12.6|5.3|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 3 - Test 2|Testing equivalence with respect to microsphere uptake rate.||5.3|-12.6|
71080247|NCT03782571|141667244|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|4.18|||TWO_SIDED|99.1|-13.9|10.3|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 2 - Test 1|Testing equivalence with respect to microsphere uptake rate.||10.3|-13.9|
71080248|NCT03498313|141667268|SUPERIORITY||Slope|-0.25|STANDARD_ERROR_OF_MEAN|0.082||0.002|TWO_SIDED|95.0|-0.41|-0.08|||Mixed Models Analysis|This is the p-value for the Treatment X Cycle Phase Interaction. Kenward-Roger Method was utilized for degrees of freedom.|Placebo represents the reference treatment.|Fixed interaction effect of treatment (0=Placebo, 1=E2) by cycle phase (0=Lower-Risk Early Luteal Baseline, 1=Higher-Risk Perimenstrual Phase) predicting SI severity in a multilevel model (with daily observations nested within conditions nested within participants over time).||-.08|-.41|.002
71080249|NCT03498313|141667268|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.083||0.46|TWO_SIDED|95.0|-0.22|0.1|||Mixed Models Analysis|This is the p-value for the Treatment X Cycle Phase Interaction. Kenward-Roger Method was utilized for degrees of freedom.|Placebo Represents the Reference Condition.|Fixed interaction effect of treatment (0=Placebo, 1=P4) by cycle phase (0=Lower-Risk Early Luteal Baseline, 1=Higher-Risk Perimenstrual Phase) predicting SI severity in a multilevel model (with daily observations nested within conditions nested within participants over time).||.10|-.22|.46
71080250|NCT01579669|141667304|SUPERIORITY_OR_OTHER|||||||0.0269|TWO_SIDED||||||t-test, 2 sided|||Pre-post comparison||||0.0269
71080251|NCT01579669|141667305|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Pre-post intervention comparison||||<0.0001
71080252|NCT01579669|141667306|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||t-test, 2 sided|||Pre-post intervention comparison||||0.016
71080253|NCT00527124|141667307|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.907|STANDARD_ERROR_OF_MEAN|0.2973||0.7428|TWO_SIDED|95.0|0.506|1.624|||Regression, Cox|||||1.624|0.506|0.7428
71080254|NCT00527124|141667307|SUPERIORITY_OR_OTHER|||||||0.7425|TWO_SIDED|95.0|||||Log Rank|||||||0.7425
71118910|NCT02979093|141742763|SUPERIORITY||Mean Difference (Final Values)|0.09778|STANDARD_ERROR_OF_MEAN|0.09687||0.319|TWO_SIDED|||||unadjusted|Mixed Models Analysis|||"This is a mixed effects model with group (Addiction vs. Control) and condition (Oxytocin \[OT\] vs Placebo).~Both variables were included in the model. The interaction effect was tested but not included in the model. This result focuses on OT vs. placebo for Ventromedial prefrontal cortex (vmPFC) for happy own vs. happy unknown infant faces."||||0.319
71118911|NCT02979093|141742763|SUPERIORITY||Mean Difference (Final Values)|-0.15289|STANDARD_ERROR_OF_MEAN|0.10968||0.171|TWO_SIDED|||||unadjusted|Mixed Models Analysis|||"This is a mixed effects model with group (addiction vs. control) and condition (OT vs Placebo).~Both variables were included in the model. The interaction effect was tested but not included in the model. This result focuses on addiction vs. control for vmPFC for Happy Own vs. Happy Unknown infant faces."||||0.171
70943377|NCT01177137|141387097|SUPERIORITY||Slope|-13.7|STANDARD_ERROR_OF_MEAN|4.24||0.001|TWO_SIDED|95.0|-22.02|-5.38||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||-5.38|-22.02|0.001
71080255|NCT03959527|141667324|NON_INFERIORITY|A single oral 3 g dose of zoliflodacin would be considered as non-inferior to a combination of a single IM 500 mg dose of ceftriaxone and a single 1 g oral dose of azithromycin if the upper bound of the 2-sided 95% CI for the microbiological cure rate of the combination therapy minus zoliflodacin was less than 12% (prespecified non-inferiority \[NI\] margin for the primary endpoint).|Risk Difference (RD)|5.31|||||TWO_SIDED|95.0|1.38|8.65|||||95% CI of the treatment difference of ceftriaxone+ azithromycin combination minus zoliflodacin|Point estimate for the treatment difference in proportion of ceftriaxone/azithromycin combination and zoliflodacin with microbiological cure and 2-sided 95% CI calculated by Newcombe score method.||8.65|1.38|
71118912|NCT02979093|141742763|SUPERIORITY||Mean Difference (Final Values)|-0.20839|STANDARD_ERROR_OF_MEAN|0.08405||0.0179|TWO_SIDED|||||Unadjusted|Mixed Models Analysis|||"This is a mixed effects model with group (addiction vs. control) and condition (OT vs Placebo).~Both variables were included in the model. The interaction effect was tested but not included in the model. This result focuses on OT vs placebo for Dorsolateral Prefrontal Cortex (dlPFC) for Sad Own vs. Sad Unknown infant faces."||||0.0179
71118913|NCT02979093|141742763|SUPERIORITY||Mean Difference (Final Values)|0.04315|STANDARD_ERROR_OF_MEAN|0.11827||0.7171|TWO_SIDED|||||unadjusted|Mixed Models Analysis|||"This is a mixed effects model with group (addiction vs. control) and condition (OT vs Placebo).~Both variables were included in the model. The interaction effect was tested but not included in the model. This result focuses on addiction vs. control for dlPFC for Sad Own vs. Sad Unknown infant faces."||||0.7171
71118914|NCT01096368|141742764|SUPERIORITY||Hazard Ratio (HR)|0.866||||0.229|TWO_SIDED|90.46|0.627|1.197||P-value is one-sided. After adjusting for interim analyses, the a priori threshold for significance for the final analysis is one-sided alpha=0.031.|Log Rank||Hazard ratio is based on hazard of events for Arm II over hazard of events for Arm III. Confidence interval is stage-wise adjusted for multiple interim analyses.|The study was designed to test the superiority of RT+maintenance vs. RT alone as measured by EFS using the hazard ratio via a 1-sided log-rank test. The planned sample size was 160 subjects per arm. 85 EFS events were needed, which were expected after 8 years of accrual and 2 years of follow-up. At 5% type 1 error, the study had 93% power to detect an increase in 2-year EFS from 75% (RT alone) to 87% (RT+maintenance). The design also incorporated interim analyses for futility and efficacy.||1.197|0.627|0.229
71118915|NCT01096368|141742765|SUPERIORITY||Hazard Ratio (HR)|0.757||||0.172|TWO_SIDED|90.46|0.463|1.238||P-value is one-sided. After adjusting for interim analyses, the a priori threshold for significance for the final analysis is one-sided alpha=0.031.|Log Rank||Hazard ratio is based on hazard of death for Arm II over hazard of death for Arm III. Confidence interval is stage-wise adjusted for multiple interim analyses.|It was planned to test the superiority of RT+maintenance vs. RT alone as measured by OS using the hazard ratio via a 1-sided log-rank test using the planned sample size of 160 subjects per arm which was optimized for the EFS outcome. A one-sided significance threshold of 5% was planned for this comparison as well.||1.238|0.463|0.172
71118916|NCT01096368|141742766|SUPERIORITY||Hazard Ratio (HR)|0.701||||0.096|TWO_SIDED|95.0|0.461|1.068||P-value is two-sided and not adjusted for multiple comparisons for this exploratory subgroup comparison.|Log Rank||Hazard ratio is based on hazard of events for Arm II over hazard of events for Arm III.|In stratum 1, it was also planned to test the superiority of RT+maintenance vs. RT alone as measured by EFS using the hazard ratio via a 2-sided log-rank test. A two-sided significance threshold of 5% was planned for this comparison.||1.068|0.461|0.096
71118917|NCT01096368|141742767|SUPERIORITY||Hazard Ratio (HR)|2.684||||0.041|TWO_SIDED|95.0|1.004|7.175||P-value is two-sided and not adjusted for multiple comparisons for this exploratory subgroup comparison.|Log Rank||Hazard ratio is based on hazard of events for Arm II over hazard of events for Arm III.|In stratum 2, it was also planned to test the superiority of RT+maintenance vs. RT alone as measured by EFS using the hazard ratio via a 2-sided log-rank test. A two-sided significance threshold of 5% was planned for this comparison.||7.175|1.004|0.041
71118918|NCT01096368|141742768|SUPERIORITY||Hazard Ratio (HR)|0.547||||0.067|TWO_SIDED|95.0|0.284|1.053||P-value is two-sided and not adjusted for multiple comparisons for this exploratory subgroup comparison.|Log Rank||Hazard ratio is based on hazard of death for Arm II over death of events for Arm III.|In stratum 1, it was also planned to test the superiority of RT+maintenance vs. RT alone as measured by OS using the hazard ratio via a 2-sided log-rank test. A two-sided significance threshold of 5% was planned for this comparison.||1.053|0.284|0.067
71118919|NCT01096368|141742769|SUPERIORITY||Hazard Ratio (HR)|3.601||||0.094|TWO_SIDED|95.0|0.724|17.902||P-value is two-sided and not adjusted for multiple comparisons for this exploratory subgroup comparison.|Log Rank||Hazard ratio is based on hazard of death for Arm II over hazard of death for Arm III.|In stratum 2, it was also planned to test the superiority of RT+maintenance vs. RT alone as measured by OS using the hazard ratio via a 2-sided log-rank test. A two-sided significance threshold of 5% was planned for this comparison.||17.902|0.724|0.094
71118920|NCT03070223|141742774|SUPERIORITY||Mean Difference (Net)|-0.1||||0.31|TWO_SIDED|95.0|-0.3|0.1|||Mixed Models Analysis|P-value is from the time and treatment group interaction.|Treatment effect was estimated as the difference in annualized rate of change (slope) with randomized pitavastatin compared to placebo from linear mixed effects models (0 reflects no difference between treatment groups).|||0.10|-0.30|0.31
71118921|NCT03070223|141742776|SUPERIORITY||Mean Difference (Final Values)|0.58||||0.62|TWO_SIDED|95.0|-1.72|2.88|||Regression, Linear||Treatment group difference was estimated using baseline-adjusted linear regression model.|Comparison of Month 24 values||2.88|-1.72|0.62
71118922|NCT03070223|141742777|SUPERIORITY||Mean Difference (Net)|-0.001||||0.61|TWO_SIDED|95.0|-0.007|0.004|||Mixed Models Analysis|P-value is from the time and treatment group interaction.|Treatment effect was estimated as the difference in annualized rate of change (slope) with randomized pitavastatin compared to placebo from linear mixed effects models (0 reflects no difference between treatment groups).|||0.004|-0.007|0.61
71080256|NCT03224624|141667371|EQUIVALENCE|Comparing baseline-\>12month SBP change (mean difference) between the two groups.|Mean Difference (Net)|-1.35|STANDARD_ERROR_OF_MEAN|3.8||0.72|TWO_SIDED|||||p\<0.05 considered significant.|t-test, 2 sided||direction of comparison: (self-management change over 12 months) - (usual care change over 12 months) in SBP|t- tests were done to compare group mean differences between self-management and usual care and within groups Mean differences were calculated by subtracting 12-month blood pressure from baseline blood pressure for each participant. t-tests were done to compare mean differences between the two groups.||||0.72
71080257|NCT03224624|141667371|EQUIVALENCE|Comparing baseline-\>12month DBP change (mean difference) between the two groups.|Mean Difference (Net)|-3.75|STANDARD_ERROR_OF_MEAN|2.55||0.15|TWO_SIDED||||||t-test, 2 sided||direction of comparison: (self-management change over 12 months) - (usual care change over 12 months) in DBP|Mean differences were calculated by subtracting 12-month blood pressure from baseline blood pressure for each participant. t-tests were done to compare mean differences between the two groups.||||0.15
71080258|NCT03224624|141667371|EQUIVALENCE|Comparing baseline-\>12month SBP change within self-management group (null hypothesis no change).|Mean Difference (Net)|-6.95||||0.01|TWO_SIDED||||||t-test, 2 sided||(12-month SBP)-(baseline SBP) for self-management group (as given in table)|change in SBP from baseline to 12-months within self-management group.||||0.01
71080259|NCT03224624|141667371|EQUIVALENCE|Comparing baseline-\>12month SBP change within usual care group (null hypothesis no change).|Mean Difference (Net)|-5.59|||<|0.05|TWO_SIDED||||||t-test, 2 sided||(12-month SBP)-(baseline SBP) for usual care group (as given in table)|Comparing baseline-\>12month SBP change within usual care group.||||<0.05
71080260|NCT03224624|141667371|EQUIVALENCE|Comparing baseline-\>12month DBP change within self-management group (null hypothesis no change).|Mean Difference (Net)|-5.51|||<|0.01|TWO_SIDED||||||t-test, 2 sided||(12-month DBP)-(baseline DBP) for self-management group (as given in table)|change in DBP from baseline to 12-months within self-management group.||||<0.01
71080261|NCT03224624|141667371|EQUIVALENCE|change in DBP from baseline to 12-months within usual care group.|Mean Difference (Net)|-1.76||||0.34|TWO_SIDED||||||t-test, 2 sided||(12-month DBP)-(baseline DBP) for usual care group (as given in table)|||||0.34
71080262|NCT01884545|141667374|SUPERIORITY|||||||0.1073|||||||Regression, Linear|||||||0.1073
71080263|NCT01884545|141667374|SUPERIORITY|||||||0.0615|||||||Regression, Linear|||||||0.0615
71080264|NCT01884545|141667375|SUPERIORITY|||||||0.6732|||||||Regression, Linear|||||||0.6732
71080265|NCT01884545|141667375|SUPERIORITY|||||||0.3754|||||||Regression, Linear|||||||0.3754
71080266|NCT01884545|141667376|SUPERIORITY||Odds Ratio (OR)|2.853||||0.0073|TWO_SIDED|95.0|1.326|6.139|||Regression, Logistic|||||6.139|1.326|0.0073
71080267|NCT01884545|141667376|SUPERIORITY||Odds Ratio (OR)|1.045||||0.9068|TWO_SIDED|95.0|0.5|2.183|||Regression, Logistic|||||2.183|0.5|0.9068
71080268|NCT01884545|141667377|SUPERIORITY||Odds Ratio (OR)|1.333||||0.7822|TWO_SIDED|95.0|0.173|10.254|||Regression, Logistic|||||10.254|0.173|0.7822
71118923|NCT03070223|141742778|SUPERIORITY||Mean Difference (Net)|-0.028||||0.8|TWO_SIDED|95.0|-0.25|0.19|||Mixed Models Analysis|P-value is from the time and treatment group interaction.|Treatment effect was estimated as the difference in annualized rate of change (slope) with randomized pitavastatin compared to placebo from linear mixed effects models (0 reflects no difference between treatment groups).|||0.19|-0.25|0.80
71080269|NCT01884545|141667377|SUPERIORITY||Odds Ratio (OR)|1.333||||0.7822|TWO_SIDED|95.0|0.173|10.254|||Regression, Logistic|||||10.254|0.173|0.7822
71080270|NCT01884545|141667378|SUPERIORITY|||||||0.7985|||||||Regression, Linear|||||||0.7985
71080271|NCT01884545|141667378|SUPERIORITY|||||||0.1642|||||||Regression, Linear|||||||0.1642
71080272|NCT01884545|141667379|SUPERIORITY|||||||0.8027|||||||Regression, Linear|||||||0.8027
71080273|NCT01884545|141667379|SUPERIORITY|||||||0.7751|||||||Regression, Linear|||||||0.7751
71080274|NCT01884545|141667380|SUPERIORITY|||||||0.5557|||||||Regression, Linear|||||||0.5557
71080275|NCT01884545|141667380|SUPERIORITY|||||||0.7834|||||||Regression, Linear|||||||0.7834
71080276|NCT01884545|141667381|SUPERIORITY|||||||0.1439|||||||Regression, Linear|||||||0.1439
71080277|NCT01884545|141667381|SUPERIORITY|||||||0.2275|||||||Regression, Linear|||||||0.2275
71080278|NCT01884545|141667382|SUPERIORITY|||||||0.7639|||||||Regression, Linear|||||||0.7639
71080279|NCT01884545|141667382|SUPERIORITY|||||||0.9999|||||||Regression, Linear|||||||0.9999
71080280|NCT01884545|141667383|SUPERIORITY|||||||0.4673|||||||Regression, Linear|||||||0.4673
71080281|NCT01884545|141667383|SUPERIORITY|||||||0.2297|||||||Regression, Linear|||||||0.2297
71080282|NCT01884545|141667384|SUPERIORITY|||||||0.2192|||||||Regression, Linear|||||||0.2192
71080283|NCT01884545|141667384|SUPERIORITY|||||||0.9062|||||||Regression, Linear|||||||0.9062
71080284|NCT01884545|141667385|SUPERIORITY|||||||0.1466|||||||Regression, Linear|||||||0.1466
71080285|NCT01884545|141667385|SUPERIORITY|||||||0.207|||||||Regression, Linear|||||||0.2070
71080286|NCT01884545|141667386|SUPERIORITY|||||||0.6289|||||||Regression, Linear|||||||0.6289
71080287|NCT01884545|141667386|SUPERIORITY|||||||0.9631|||||||Regression, Linear|||||||0.9631
71080288|NCT01884545|141667387|SUPERIORITY|||||||0.2313|||||||Regression, Linear|||||||0.2313
71080289|NCT01884545|141667387|SUPERIORITY|||||||0.8029|||||||Regression, Linear|||||||0.8029
71080290|NCT01884545|141667388|SUPERIORITY|||||||0.071|||||||Regression, Linear|||||||0.0710
71080291|NCT01884545|141667388|SUPERIORITY|||||||0.8069|||||||Regression, Linear|||||||0.8069
71080292|NCT01884545|141667389|SUPERIORITY|||||||0.0512|||||||Chi-squared|||||||0.0512
71080293|NCT01884545|141667389|SUPERIORITY|||||||0.4478|||||||Chi-squared|||||||0.4478
71080294|NCT01884545|141667392|SUPERIORITY|||||||0.7923|||||||Regression, Linear|||Perceived Risk for CHD, Consequences subscale||||0.7923
71080295|NCT01884545|141667392|SUPERIORITY|||||||0.0636|||||||Regression, Linear|||Perceived Risk for CHD, Personal control||||0.0636
71080296|NCT01884545|141667392|SUPERIORITY|||||||0.2063|||||||Regression, Linear|||Perceived Risk for CHD, Treatment control||||0.2063
71080297|NCT01884545|141667392|SUPERIORITY|||||||0.2529|||||||Regression, Linear|||Perceived Risk for CHD, Emotional representations||||0.2529
71080298|NCT01884545|141667392|SUPERIORITY|||||||0.1085|||||||Regression, Linear|||Perceived Risk for coronary heart disease (CHD), Consequences subscale||||0.1085
70854821|NCT02660138|141198070|SUPERIORITY|Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|4.0||||0.0007|TWO_SIDED|95.0|1.8|8.86||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥30% Improvement Level: Dysport® 600 U versus Placebo.||8.86|1.80|0.0007
71118924|NCT03070223|141742779|SUPERIORITY||Risk Ratio (RR)|1.02||||0.33|TWO_SIDED|95.0|0.98|1.06|||Log-binomial regression using GEE|P-value is from the time and treatment group interaction.|Treatment effect is shown as relative annualized risk of impairment in the pitavastatin group compared to placebo (1 reflects no difference between treatment groups).|||1.06|0.98|0.33
71118925|NCT03070223|141742780|SUPERIORITY||Mean Difference (Net)|-0.005||||0.18|TWO_SIDED|95.0|-0.013|0.002|||Mixed Models Analysis|P-value is from the time and treatment group interaction.|Treatment effect was estimated as the difference in annualized rate of change (slope) with randomized pitavastatin compared to placebo from linear mixed effects models (0 reflects no difference between treatment groups).|||0.002|-0.013|0.18
71118926|NCT03070223|141742781|SUPERIORITY||Risk Ratio (RR)|1.06||||0.47|TWO_SIDED|95.0|0.91|1.24|||Log-binomial regression using GEE|P-value is from the time (before vs. after study treatment initiation) and treatment group interaction.|Treatment effect is shown as relative average risk of impairment over follow-up time in the pitavastatin group compared to placebo (1 reflects no difference between treatment groups).|||1.24|0.91|0.47
71118927|NCT03070223|141742786|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.55|TWO_SIDED|95.0|-2.7|1.4|||Regression, Linear||Treatment group difference at Month 24 (pitavastatin minus placebo) was estimated using baseline-adjusted linear regression model (0 reflects no difference between treatment groups).|Comparison of Month 24 values||1.4|-2.7|0.55
71118928|NCT03070223|141742787|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.67|TWO_SIDED|95.0|-2.8|1.8|||Regression, Linear||Treatment group difference at Month 24 (pitavastatin minus placebo) was estimated using baseline-adjusted linear regression model (0 reflects no difference between treatment groups).|Comparison of Month 24 values||1.8|-2.8|0.67
71118929|NCT03070223|141742788|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.98|TWO_SIDED|95.0|-0.5|0.52|||Regression, Linear||Treatment group difference (pitavastatin minus placebo) at Month 24 was estimated using baseline-adjusted linear regression model (0 reflects no difference between treatment groups).|Comparison of Month 24 values||0.52|-0.50|0.98
71118930|NCT03070223|141742789|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.31|TWO_SIDED|95.0|-0.8|0.3|||Regression, Linear||Treatment group difference at Month 24 (pitavastatin minus placebo) was estimated using baseline-adjusted linear regression model (0 reflects no difference between treatment groups).|Comparison of Month 24 values||0.3|-0.8|0.31
71118931|NCT03070223|141742790|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.21|TWO_SIDED|95.0|-0.2|0.9|||Regression, Linear||Treatment group difference at Month 24 (pitavastatin minus placebo) was estimated using baseline-adjusted linear regression model (0 reflects no difference between treatment groups).|Comparison of Month 24 values||0.9|-0.2|0.21
71118932|NCT02684058|141742797|SUPERIORITY|one-sided p-value at 2.5% level of significance|Odds Ratio (OR)|7.19|||<|0.001|TWO_SIDED|95.0|2.3|22.4|||Chi-squared|||||22.4|2.3|<0.001
71118933|NCT02684058|141742802|SUPERIORITY||Hazard Ratio (HR)|0.31|||<|0.001|TWO_SIDED|95.0|0.17|0.55||Log-rank test at an overall one-sided 2.5% level of significance|Log Rank|||Up to approx. 3 years||0.55|0.17|<0.001
70943378|NCT01177137|141387098|SUPERIORITY||Slope|3.71|STANDARD_ERROR_OF_MEAN|3.91||0.34|TWO_SIDED|95.0|-3.96|11.38||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||11.38|-3.96|0.34
71118934|NCT00443053|141742852|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.15|||<|0.001|TWO_SIDED|95.0|0.08|0.26|||Fisher Exact|||||0.26|0.08|<0.001
71118935|NCT00443053|141742853|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.19|||<|0.001|TWO_SIDED|95.0|0.12|0.32|||Fisher Exact|||||0.32|0.12|<0.001
71118936|NCT00350272|141742859|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-13.5|||||TWO_SIDED|95.0|-35.2|8.2||||||The difference in proportions between the group of participants who received lamivudine 300 mg/day (in combination with efavirenz and tenofovir) over 12 weeks and the group of participants who received elvucitabine 10 mg/day (in combination with efavirenz and tenofovir) over 12 weeks along with corresponding 2-sided 95% confidence interval for risk difference using asymptotic normal theory.||8.2|-35.2|
71118937|NCT02226198|141742861|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-22.3||||0.005|TWO_SIDED|95.0|-33.5|-9.1||statistical significance set at 0.05|Mixed Models Analysis||Rosuvastatin treatment gives on average a 22.3% lower geometric LS mean than placebo.|cross-over, null hypothesis is no difference between ros and plc. Powered for 90% detection of 15% delta||-9.1|-33.5|0.005
71118938|NCT02226198|141742862|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-22.3||||0.005|TWO_SIDED|95.0|-33.5|-9.1||statistical significance set at 0.05|Mixed Models Analysis||Rosuvastatin treatment gives on average a 22.3% lower geometric LS mean than placebo.|cross-over, null hypothesis is no difference between ros and plc. Powered for 90% detection of 15% delta||-9.1|-33.5|0.005
71118939|NCT02226198|141742863|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-20.1||||0.003|TWO_SIDED|95.0|-29.7|-9.1||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-9.1|-29.7|0.003
71118940|NCT02226198|141742864|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-20.1||||0.003|TWO_SIDED|95.0|-29.7|-9.1||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-9.1|-29.7|0.003
71118941|NCT02226198|141742865|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-22.9||||0.003|TWO_SIDED|95.0|-33.7|-10.3||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-10.3|-33.7|0.003
71118942|NCT02226198|141742866|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-22.9||||0.003|TWO_SIDED|95.0|-33.7|-10.3||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-10.3|-33.7|0.003
71118943|NCT02226198|141742867|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-17.1||||0.024|TWO_SIDED|95.0|-29.2|-2.9||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-2.9|-29.2|0.024
71118944|NCT02226198|141742868|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-17.1||||0.024|TWO_SIDED|95.0|-29.2|-2.9||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-2.9|-29.2|0.024
71118945|NCT02226198|141742869|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|7.4||||0.314|TWO_SIDED|95.0|-7.4|24.5||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||24.5|-7.4|0.314
71118946|NCT02226198|141742870|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|7.4||||0.314|TWO_SIDED|95.0|-7.4|24.5||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||24.5|-7.4|0.314
71118947|NCT02226198|141742871|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-26.3||||0.08|TWO_SIDED|95.0|-48.7|6.0||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||6.0|-48.7|0.080
71118948|NCT02226198|141742872|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-26.3||||0.08|TWO_SIDED|95.0|-48.7|6.0||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||6.0|-48.7|0.080
71118949|NCT02226198|141742883|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-30.4||||0.004|TWO_SIDED|95.0|-44.2|-13.3||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-13.3|-44.2|0.004
71118950|NCT02226198|141742884|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-30.4||||0.004|TWO_SIDED|95.0|-44.2|-13.3||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-13.3|-44.2|0.004
71118951|NCT02226198|141742885|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-27.6||||0.006|TWO_SIDED|95.0|-41.2|-11.0||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-11.0|-41.2|0.006
71118952|NCT02226198|141742886|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-25.6||||0.005|TWO_SIDED|95.0|-38.1|-10.5||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-10.5|-38.1|0.005
71118953|NCT02226198|141742887|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-28.2||||0.005|TWO_SIDED|95.0|-41.7|-11.4||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-11.4|-41.7|0.005
71118954|NCT02226198|141742888|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-20.4||||0.013|TWO_SIDED|95.0|-32.8|-5.6||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-5.6|-32.8|0.013
71118955|NCT01288612|141742898|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Chi-squared|||||||0.25
71118956|NCT01288612|141742898|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED||||||Chi-squared|||||||0.42
71118957|NCT01288612|141742898|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Chi-squared|||||||0.27
71118958|NCT01288612|141742898|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||Chi-squared|||||||0.82
71118959|NCT01288612|141742899|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Kruskal-Wallis|||||||0.06
71118960|NCT01288612|141742900|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Fisher Exact|||||||0.08
71118961|NCT01288612|141742901|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Kruskal-Wallis|||||||0.001
71118962|NCT01288612|141742902|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
71118963|NCT01288612|141742903|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
71118964|NCT01288612|141742904|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the arms for pain scale||||<0.001
71118965|NCT01288612|141742904|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the arms for choking scale||||<0.001
71118966|NCT01288612|141742904|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the arms for gagging scale||||<0.001
71118967|NCT01288612|141742904|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the arms for anxiety scale||||<0.001
71118968|NCT01288612|141742904|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||Comparison between arms for overall tolerance scale||||<0.001
71118969|NCT01288612|141742905|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Kruskal-Wallis|||||||0.001
71118970|NCT00395291|141742913|SUPERIORITY_OR_OTHER||||||<|0.001||||||The IGF-1 data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.|ANCOVA|||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in IGF-1 is the same for both the MK-0677 and placebo interventions.~Power calculation: We assumed that the IGF-I data will be lognormally distributed and thus the parameter of interest will be the IGF-1 geometric mean. If n=22 individuals complete the study and the intervention effect is 48% greater for one intervention than the other we will have at least 0.80 power to reject the null hypothesis."||||<0.001
71118971|NCT00395291|141742914|SUPERIORITY_OR_OTHER|||||||0.169|||||||ANCOVA|The Acyl-Ghrelin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in Acyl-Ghrelin is the same for both the MK-0677 and placebo interventions.~Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted."||||0.169
71118972|NCT00395291|141742915|SUPERIORITY_OR_OTHER|||||||0.063|||||||ANCOVA|The Leptin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in leptin is the same for both the MK-0677 and placebo interventions.~Because Leptin is considered a secondary outcome, no power analysis was conducted."||||0.063
71118973|NCT00395291|141742916|SUPERIORITY_OR_OTHER|||||||0.075|||||||ANCOVA|The insulin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in serum-insulin is the same for both the MK-0677 and placebo interventions.~Because serum-insulin is considered a secondary outcome, no power analysis was conducted."||||0.075
71080299|NCT01884545|141667392|SUPERIORITY|||||||0.337|||||||Regression, Linear|||Perceived Risk for coronary heart disease (CHD), personal control subscale||||0.3370
71080300|NCT01884545|141667392|SUPERIORITY|||||||0.3483|||||||Regression, Linear|||Perceived Risk for coronary heart disease (CHD), treatment control subscale||||0.3483
70854822|NCT02660138|141198070|SUPERIORITY|Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|3.63||||0.0012|TWO_SIDED|95.0|1.68|7.86||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥30% Improvement Level: Dysport® 800 U versus Placebo||7.86|1.68|0.0012
70854823|NCT02660138|141198070|SUPERIORITY|Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|8.03|||<|0.0001|TWO_SIDED|95.0|3.56|18.09||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥50% Improvement Level: Dysport® 600 U versus Placebo.||18.09|3.56|<0.0001
70854824|NCT02660138|141198070|SUPERIORITY|Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|8.22|||<|0.0001|TWO_SIDED|95.0|3.66|18.47||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥50% Improvement Level: Dysport® 800 U versus Placebo||18.47|3.66|<0.0001
70854825|NCT02660138|141198070|OTHER|Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|10.7|||<|0.0001|TWO_SIDED|95.0|4.59|24.95||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥75% Improvement Level: Dysport® 600 U versus Placebo.||24.95|4.59|<0.0001
70854826|NCT02660138|141198070|SUPERIORITY|Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|12.63|||<|0.0001|TWO_SIDED|95.0|5.4|29.56||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥75% Improvement Level: Dysport® 800 U versus Placebo.||29.56|5.40|<0.0001
71080301|NCT01884545|141667392|SUPERIORITY|||||||0.5384|||||||Regression, Linear|||Perceived Risk for coronary heart disease (CHD), emotional representations||||0.5384
71080302|NCT01884545|141667393|SUPERIORITY|||||||0.7447|||||||Regression, Linear|||Perceived Risk for T2D, Consequences subscale||||0.7447
71080303|NCT01884545|141667393|SUPERIORITY|||||||0.6378|||||||Regression, Linear|||Perceived Risk for T2D, Personal control||||0.6378
71080304|NCT01884545|141667393|SUPERIORITY|||||||0.3209|||||||Regression, Linear|||Perceived Risk for T2D, Treatment control||||0.3209
71080305|NCT01884545|141667393|SUPERIORITY|||||||0.0058|||||||Regression, Linear|||Perceived Risk for T2D, Emotional representations||||0.0058
71080306|NCT01884545|141667393|SUPERIORITY|||||||0.3769|||||||Regression, Linear|||Perceived Risk for type 2 diabetes (T2D), Consequences subscale||||0.3769
71080307|NCT01884545|141667393|SUPERIORITY|||||||0.0872|||||||Regression, Linear|||Perceived Risk for type 2 diabetes (T2D), personal control||||0.0872
71080308|NCT01884545|141667393|SUPERIORITY|||||||0.4302|||||||Regression, Linear|||Perceived Risk for type 2 diabetes (T2D), treatment control||||0.4302
71080309|NCT01884545|141667393|SUPERIORITY|||||||0.4133|||||||Regression, Linear|||Perceived Risk for type 2 diabetes (T2D), emotional representations||||0.4133
71080310|NCT01884545|141667394|SUPERIORITY|||||||0.3106|||||||Regression, Linear|||||||0.3106
71080311|NCT01884545|141667394|SUPERIORITY|||||||0.7087|||||||Regression, Linear|||||||0.7087
71080312|NCT01884545|141667395|SUPERIORITY||Odds Ratio (OR)|1.034||||0.9259|TWO_SIDED|95.0|0.511|2.094|||Regression, Logistic|||Stages of Change, Weight reduction||2.094|0.511|0.9259
71080313|NCT01884545|141667395|SUPERIORITY||Odds Ratio (OR)|2.252||||0.0082|TWO_SIDED|95.0|1.234|4.111|||Regression, Logistic|||Stages of Change, Exercise behavior||4.111|1.234|0.0082
71080314|NCT01884545|141667395|SUPERIORITY||Odds Ratio (OR)|0.423||||0.2954|TWO_SIDED|95.0|0.084|2.12|||Regression, Logistic|||Stages of Change, Smoking behavior||2.120|0.084|0.2954
71080315|NCT01884545|141667395|SUPERIORITY||Odds Ratio (OR)|1.216||||0.5669|TWO_SIDED|95.0|0.622|2.376|||Regression, Logistic|||Stages of Change, Healthier eating behavior||2.376|0.622|0.5669
71080316|NCT01884545|141667395|SUPERIORITY||Odds Ratio (OR)|0.622||||0.121|TWO_SIDED|95.0|0.341|1.134|||Regression, Logistic|||Stages of Change, Stress behavior||1.134|0.341|0.1210
71080317|NCT01884545|141667395|SUPERIORITY||Odds Ratio (OR)|0.928||||0.8355|TWO_SIDED|95.0|0.461|1.872|||Regression, Logistic|||Weight reduction||1.872|0.461|0.8355
71080318|NCT01884545|141667395|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0459|TWO_SIDED|95.0|1.011|3.311|||Regression, Logistic|||Exercise behavior||3.311|1.011|0.0459
71080319|NCT01884545|141667395|SUPERIORITY||Odds Ratio (OR)|0.563||||0.465|TWO_SIDED|95.0|0.121|2.629|||Regression, Logistic|||Smoking behavior||2.629|0.121|0.4650
71080320|NCT01884545|141667395|SUPERIORITY||Odds Ratio (OR)|0.93||||0.8303|TWO_SIDED|95.0|0.478|1.808|||Regression, Logistic|||Healthier eating behavior||1.808|0.478|0.8303
71080321|NCT01884545|141667395|SUPERIORITY||Odds Ratio (OR)|1.347||||0.3254|TWO_SIDED|95.0|0.744|2.439|||Regression, Logistic|||Stress behavior||2.439|0.744|0.3254
71080322|NCT01884545|141667396|SUPERIORITY|||||||0.0174|||||||Regression, Linear|||||||0.0174
71080323|NCT01884545|141667396|SUPERIORITY|||||||0.8694|||||||Regression, Linear|||||||0.8694
71080324|NCT01884545|141667397|SUPERIORITY|||||||0.4768|||||||Regression, Linear|||||||0.4768
71080325|NCT01884545|141667397|SUPERIORITY|||||||0.8452|||||||Regression, Linear|||||||0.8452
71080326|NCT01884545|141667398|SUPERIORITY||Odds Ratio (OR)|1.591||||0.5589|TWO_SIDED|95.0|0.335|7.544|||Regression, Logistic|||||7.544|0.335|0.5589
70943379|NCT01177137|141387098|SUPERIORITY||Slope|-0.23|STANDARD_ERROR_OF_MEAN|3.82||0.95|TWO_SIDED|95.0|-7.72|7.26||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||7.26|-7.72|0.95
70943380|NCT01177137|141387099|SUPERIORITY||Slope|-1.85|STANDARD_ERROR_OF_MEAN|3.69||0.62|TWO_SIDED|95.0|-9.07|5.38||The a priori threshold for statistical significance was \< 0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||5.38|-9.07|0.62
71080327|NCT00519584|141667399|SUPERIORITY||Hazard Ratio (HR)|0.17|||<|0.001|TWO_SIDED|95.0|0.08|0.39|||Log Rank||Ropivacaine/dex vs. Ropivacaine/saline|||0.39|0.08|<0.001
71080328|NCT00519584|141667399|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.001|TWO_SIDED|95.0|0.23|0.83|||Log Rank||bupivacaine/dex vs. bupivacaine/Saline|||0.83|0.23|<0.001
71080329|NCT00519584|141667400|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
71080330|NCT00519584|141667400|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
71080331|NCT00519584|141667401|SUPERIORITY||||||<|0.001||||||adjusted significance level is 0.025|Wilcoxon (Mann-Whitney)|||||||<0.001
71080332|NCT00519584|141667401|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
71080333|NCT00519584|141667402|SUPERIORITY|||||||0.29||||||adjusted significance level = 0.025|Wilcoxon (Mann-Whitney)|||||||0.29
71080334|NCT00519584|141667402|SUPERIORITY|||||||0.15||||||adjusted significance level = 0.025|Wilcoxon (Mann-Whitney)|||||||0.15
71118974|NCT00395291|141742917|SUPERIORITY_OR_OTHER|||||||0.782||95.0|||||ANCOVA|||||||.782
70943381|NCT01177137|141387099|SUPERIORITY||Slope|-4.46|STANDARD_ERROR_OF_MEAN|3.58||0.21|TWO_SIDED|95.0|-11.48|2.55||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||2.55|-11.48|0.21
70943382|NCT01177137|141387100|SUPERIORITY||Slope|-0.13|STANDARD_ERROR_OF_MEAN|3.39||0.97|TWO_SIDED|95.0|-6.78|6.52||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||6.52|-6.78|0.97
70943383|NCT01177137|141387100|SUPERIORITY||Slope|-3.02|STANDARD_ERROR_OF_MEAN|3.27||0.36|TWO_SIDED|95.0|-9.43|3.4||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||3.40|-9.43|0.36
71118975|NCT00395291|141742918|SUPERIORITY_OR_OTHER|||||||0.385|||||||ANCOVA|The TNF-a data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in TNF-a is the same for both the MK-0677 and placebo interventions.~Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted."||||0.385
71080335|NCT00351936|141667434|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANCOVA|||||||0.003
71080336|NCT00351936|141667435|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANCOVA|||||||0.003
71080337|NCT00351936|141667436|SUPERIORITY_OR_OTHER|||||||0.747||95.0|||||ANCOVA|||||||0.747
71080338|NCT00351936|141667437|SUPERIORITY_OR_OTHER|||||||0.208||95.0|||||ANCOVA|||||||0.208
71080339|NCT00351936|141667438|SUPERIORITY_OR_OTHER|||||||0.665||95.0|||||ANCOVA|||||||0.665
71080340|NCT00351936|141667439|SUPERIORITY_OR_OTHER|||||||0.999||95.0|||||ANCOVA|||||||0.999
71080341|NCT00351936|141667440|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||||||0.001
71080342|NCT02937636|141667441|OTHER||Least square (LS) mean difference|-0.09|||<|0.0001|TWO_SIDED|95.0|-0.12|-0.07|||ANCOVA|From ANCOVA with treatment, gender, smoking status and baseline MGI stratification as factors and baseline as covariate.|Difference is the first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||-0.07|-0.12|<.0001
71080343|NCT00583011|141667456|EQUIVALENCE||Median Difference (Final Values)|0.02|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71080344|NCT02559570|141667511|SUPERIORITY||Least Squares Mean Difference|-0.042|STANDARD_ERROR_OF_MEAN|0.149||0.7789|TWO_SIDED|95.0|-0.335|0.252|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.252|-0.335|0.7789
71080345|NCT02559570|141667511|SUPERIORITY||Least Squares Mean Difference|0.001|STANDARD_ERROR_OF_MEAN|0.143||0.993|TWO_SIDED|95.0|-0.282|0.284|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.284|-0.282|0.9930
71080346|NCT02559570|141667511|SUPERIORITY||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.146||0.4107|TWO_SIDED|95.0|-0.167|0.408|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.408|-0.167|0.4107
71080347|NCT02559570|141667512|SUPERIORITY||Least Squares Mean Difference|-0.588|STANDARD_ERROR_OF_MEAN|0.577||0.3097|TWO_SIDED|95.0|-1.729|0.552|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.552|-1.729|0.3097
70943384|NCT01177137|141387101|SUPERIORITY||Slope|1.24|STANDARD_ERROR_OF_MEAN|3.01||0.68|TWO_SIDED|95.0|-4.67|7.14||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||7.14|-4.67|0.68
70943385|NCT01177137|141387101|SUPERIORITY||Slope|-3.52|STANDARD_ERROR_OF_MEAN|2.93||0.23|TWO_SIDED|95.0|-9.26|2.23||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||2.23|-9.26|0.23
70943386|NCT01177137|141387102|SUPERIORITY||Slope|-0.82|STANDARD_ERROR_OF_MEAN|1.27||0.52|TWO_SIDED|95.0|-3.3|1.66||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||1.66|-3.30|0.52
70943387|NCT01177137|141387102|SUPERIORITY||Slope|-2.81|STANDARD_ERROR_OF_MEAN|1.22||0.022|TWO_SIDED|95.0|-5.21|-0.41||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||-0.41|-5.21|0.022
70943388|NCT01177137|141387103|SUPERIORITY||Slope|0.34|STANDARD_ERROR_OF_MEAN|0.96||0.72|TWO_SIDED|95.0|-1.54|2.23||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||2.23|-1.54|0.72
71080348|NCT02559570|141667512|SUPERIORITY||Least Squares Mean Difference|-0.186|STANDARD_ERROR_OF_MEAN|0.557||0.7384|TWO_SIDED|95.0|-1.286|0.913|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.913|-1.286|0.7384
71080349|NCT02559570|141667512|SUPERIORITY||Least Squares Mean Difference|0.364|STANDARD_ERROR_OF_MEAN|0.563||0.5188|TWO_SIDED|95.0|-0.748|1.477|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||1.477|-0.748|0.5188
71080350|NCT02559570|141667513|SUPERIORITY||Least Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.249||0.8426|TWO_SIDED|95.0|-0.543|0.444|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation||0.444|-0.543|0.8426
70943389|NCT01177137|141387103|SUPERIORITY||Slope|-1.04|STANDARD_ERROR_OF_MEAN|0.91||0.26|TWO_SIDED|95.0|-2.83|0.75||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.75|-2.83|0.26
70943390|NCT01177137|141387104|SUPERIORITY||Slope|0.61|STANDARD_ERROR_OF_MEAN|0.59||0.3|TWO_SIDED|95.0|0.55|1.78||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||1.78|0.55|0.30
71080351|NCT02559570|141667513|SUPERIORITY||Least Squares Mean Difference|-0.038|STANDARD_ERROR_OF_MEAN|0.246||0.877|TWO_SIDED|95.0|-0.525|0.448|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation||0.448|-0.525|0.8770
71080352|NCT02559570|141667513|SUPERIORITY||Least Squares Mean Difference|0.356|STANDARD_ERROR_OF_MEAN|0.246||0.1502|TWO_SIDED|95.0|-0.131|0.842|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation||0.842|-0.131|0.1502
71080353|NCT02559570|141667513|SUPERIORITY||Least Squares Mean Difference|-0.062|STANDARD_ERROR_OF_MEAN|0.239||0.7949|TWO_SIDED|95.0|-0.535|0.41|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average||0.410|-0.535|0.7949
71080354|NCT02559570|141667513|SUPERIORITY||Least Squares Mean Difference|-0.074|STANDARD_ERROR_OF_MEAN|0.235||0.7543|TWO_SIDED|95.0|-0.54|0.392|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average||0.392|-0.540|0.7543
71080355|NCT02559570|141667513|SUPERIORITY||Least Squares Mean Difference|0.262|STANDARD_ERROR_OF_MEAN|0.235||0.2676|TWO_SIDED|95.0|-0.204|0.728|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average||0.728|-0.204|0.2676
71080356|NCT02559570|141667514|SUPERIORITY||Least Squares Mean Difference|-0.053|STANDARD_ERROR_OF_MEAN|0.208||0.7997|TWO_SIDED|95.0|-0.465|0.359|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation||0.359|-0.465|0.7997
71080357|NCT02559570|141667514|SUPERIORITY||Least Squares Mean Difference|-0.121|STANDARD_ERROR_OF_MEAN|0.207||0.5602|TWO_SIDED|95.0|-0.53|0.288|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation||0.288|-0.530|0.5602
71080358|NCT02559570|141667514|SUPERIORITY||Least Squares Mean Difference|-0.236|STANDARD_ERROR_OF_MEAN|0.205||0.2529|TWO_SIDED|95.0|-0.641|0.17|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation||0.170|-0.641|0.2529
71080359|NCT02559570|141667514|SUPERIORITY||Least Squares Mean Difference|-0.054|STANDARD_ERROR_OF_MEAN|0.206||0.7923|TWO_SIDED|95.0|-0.461|0.352|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average||0.352|-0.461|0.7923
71080360|NCT02559570|141667514|SUPERIORITY||Least Squares Mean Difference|-0.113|STANDARD_ERROR_OF_MEAN|0.204||0.5802|TWO_SIDED|95.0|-0.517|0.29|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average||0.290|-0.517|0.5802
71080361|NCT02559570|141667514|SUPERIORITY||Least Squares Mean Difference|-0.199|STANDARD_ERROR_OF_MEAN|0.202||0.3263|TWO_SIDED|95.0|-0.6|0.201|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average||0.201|-0.600|0.3263
71080362|NCT02559570|141667515|SUPERIORITY||Least Squares Mean Difference|0.048|STANDARD_ERROR_OF_MEAN|0.152||0.7507|TWO_SIDED|95.0|-0.252|0.349|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.349|-0.252|0.7507
71118976|NCT00395291|141742919|SUPERIORITY_OR_OTHER|||||||0.929|||||||ANCOVA|The CRPs data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in CRPs is the same for both the MK-0677 and placebo interventions.~Because CRPs is considered as a secondary outcome, no power analysis was conducted."||||0.929
71080363|NCT02559570|141667515|SUPERIORITY||Least Squares Mean Difference|0.028|STANDARD_ERROR_OF_MEAN|0.146||0.8505|TWO_SIDED|95.0|-0.262|0.317|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.317|-0.262|0.8505
71080364|NCT02559570|141667515|SUPERIORITY||Least Squares Mean Difference|0.039|STANDARD_ERROR_OF_MEAN|0.149||0.7933|TWO_SIDED|95.0|-0.254|0.332|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.332|-0.254|0.7933
71080365|NCT02559570|141667516|SUPERIORITY||Least Squares Mean Difference|-0.425|STANDARD_ERROR_OF_MEAN|0.45||0.3461|TWO_SIDED|95.0|-1.313|0.463|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.463|-1.313|0.3461
71080366|NCT02559570|141667516|SUPERIORITY||Least Squares Mean Difference|-0.235|STANDARD_ERROR_OF_MEAN|0.435||0.5892|TWO_SIDED|95.0|-1.095|0.624|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.624|-1.095|0.5892
71080367|NCT02559570|141667516|SUPERIORITY||Least Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.44||0.856|TWO_SIDED|95.0|-0.789|0.949|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.949|-0.789|0.8560
71080368|NCT00524680|141667534|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 1-Month for dose level 4000 IU. Statistical analysis was done using one sample t-test.||||<.0001
71080369|NCT00524680|141667534|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 3-Month for dose level 4000 IU. Statistical analysis was done using one sample t-test.||||<.0001
71080370|NCT00524680|141667534|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 6-Month for dose level 4000 IU. Statistical analysis was done using one sample t-test.||||<.0001
71080371|NCT00524680|141667534|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 1-Month for dose level 6000 IU. Statistical analysis was done using one sample t-test.||||<.0001
71080372|NCT00524680|141667534|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 3-Month for dose level 6000 IU. Statistical analysis was done using one sample t-test.||||<.0001
71080373|NCT00524680|141667534|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 6-Month for dose level 6000 IU. Statistical analysis was done using one sample t-test.||||<.0001
71080374|NCT00524680|141667534|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 1-Month for dose level 8000 IU. Statistical analysis was done using one sample t-test.||||<.0001
71080375|NCT00524680|141667534|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 3-Month for dose level 8000 IU. Statistical analysis was done using one sample t-test.||||<.0001
71080376|NCT00524680|141667534|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 6-Month for dose level 8000 IU. Statistical analysis was done using one sample t-test.||||<.0001
71118977|NCT00395291|141742920|SUPERIORITY_OR_OTHER|||||||0.905|||||||ANCOVA|The IL-1 data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in IL-1 is the same for both the MK-0677 and placebo interventions.~Because IL-1 is considered as a secondary outcome, no power analysis was conducted"||||0.905
71118978|NCT00395291|141742921|SUPERIORITY_OR_OTHER|||||||0.233||95.0|||||ANCOVA|||||||0.233
71118979|NCT00395291|141742922|SUPERIORITY_OR_OTHER|||||||0.277|||||||ANCOVA|The IL-10 data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in IL-10 is the same for both the MK-0677 and placebo interventions.~Because IL-10 is considered as a secondary outcome, no power analysis was conducted."||||0.277
71080377|NCT00524680|141667534|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 1-Month for dose level 10000 IU. Statistical analysis was done using one sample t-test.||||<.0001
71080378|NCT00524680|141667534|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 3-Month for dose level 10000 IU. Statistical analysis was done using one sample t-test.||||<.0001
71080379|NCT00524680|141667534|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 6-Month for dose level 10000 IU. Statistical analysis was done using one sample t-test.||||<.0001
71080380|NCT00524680|141667535|SUPERIORITY_OR_OTHER|||||||0.8244|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 1-month for 4000 IU. Statistical analysis was done using one sample t-test.||||0.8244
71080381|NCT00524680|141667535|SUPERIORITY_OR_OTHER|||||||0.1025|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 3-month for 4000 IU. Statistical analysis was done using one sample t-test.||||0.1025
71080382|NCT00524680|141667535|SUPERIORITY_OR_OTHER|||||||0.1744|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 6-Month for dose level 4000 IU.||||0.1744
70943391|NCT01177137|141387104|SUPERIORITY||Slope|-0.62|STANDARD_ERROR_OF_MEAN|0.58||0.29|TWO_SIDED|95.0|-1.75|0.52||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.52|-1.75|0.29
70943392|NCT01287416|141387105|SUPERIORITY_OR_OTHER|||||||0.61||95.0||||The a priori threshold for statistical significance was set at p\<.05. Effect size determined by partial eta-squared to be 0.01.|Mixed Models Analysis|Model was adjusted for differences in educational attainment at baseline.||The null hypothesis was that the groups would not differ in terms of SIRI scores across the three time points. We used linear mixed models to determine whether scores were different between the two groups over time.||||0.61
70943393|NCT01287416|141387106|SUPERIORITY_OR_OTHER|||||||0.95||95.0||||The a priori threshold for statistical significance was set at p\<.05. Effect size determined by partial eta-squared to be 0.02.|Mixed Models Analysis|Model was adjusted for differences in educational attainment at baseline.||The null hypothesis was that the groups would not differ in terms of level of knowledge across the three time points.||||0.95
70943394|NCT01287416|141387107|SUPERIORITY_OR_OTHER|||||||0.33||95.0||||The a priori threshold for statistical significance was set at p\<.05. Effect size determined by partial eta-squared to be 0.02.|Mixed Models Analysis|Model was adjusted for differences in educational attainment at baseline.||The null hypothesis was that the two groups would not differ in terms of self-reported skill level across the three time points.||||0.33
70943395|NCT01287416|141387108|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||The a priori threshold for statistical significance was set at p\<.05. Effect size determined by partial eta-squared to be 0.05.|Mixed Models Analysis|Model adjusted for differences in educational attainment at baseline.||The null hypothesis was that the groups would not differ in terms of level of knowledge across the three time points.||||0.03
70943396|NCT01287416|141387109|SUPERIORITY_OR_OTHER|||||||0.63||95.0||||The a priori threshold for statistical significance was set at p\<.05. Effect size determined by partial eta-squared to be 0.01.|Mixed Models Analysis|Model was adjusted for differences in educational attainment at baseline.||The null hypothesis was that the two groups would not differ on level of self-reported preparedness to help a suicidal person.||||0.63
71080383|NCT00524680|141667535|SUPERIORITY_OR_OTHER|||||||0.1281|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 1-month for 6000 IU. Statistical analysis was done using one sample t-test.||||0.1281
70943397|NCT01287416|141387110|SUPERIORITY_OR_OTHER|||||||0.21||95.0||||A priori threshold for significance set to p\<.05.|ANCOVA|Model adjusted for differences in educational attainment at baseline.||The null hypothesis was that the groups would not differ on their level of distress across the two time points.||||0.21
71080384|NCT00524680|141667535|SUPERIORITY_OR_OTHER|||||||0.9688|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 3-month for 6000 IU. Statistical analysis was done using one sample t-test.||||0.9688
71080385|NCT00524680|141667535|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 6-month for 6000 IU. Statistical analysis was done using one sample t-test.||||<0.0001
71080386|NCT00524680|141667535|SUPERIORITY_OR_OTHER|||||||0.8241|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 1-month for 8000 IU. Statistical analysis was done using one sample t-test.||||0.8241
71080387|NCT00524680|141667535|SUPERIORITY_OR_OTHER|||||||0.1828|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 3-month for 8000 IU. Statistical analysis was done using one sample t-test.||||0.1828
71080388|NCT00524680|141667535|SUPERIORITY_OR_OTHER|||||||0.1348|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 6-month for 8000 IU. Statistical analysis was done using one sample t-test.||||0.1348
71080389|NCT00524680|141667535|SUPERIORITY_OR_OTHER|||||||0.2214|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 1-month for 10000 IU. Statistical analysis was done using one sample t-test.||||0.2214
71080390|NCT00524680|141667535|SUPERIORITY_OR_OTHER|||||||0.0079|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 3-month for 10000 IU. Statistical analysis was done using one sample t-test.||||0.0079
71080391|NCT00524680|141667535|SUPERIORITY_OR_OTHER|||||||0.0631|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 6-month for 10000 IU. Statistical analysis was done using one sample t-test.||||0.0631
71080392|NCT01451554|141667563|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||2 tailed t-test|t-test, 2 sided|||Data were compared between groups using the 2 sample T-test.||||0.06
71080393|NCT01451554|141667564|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||t-test, 2 sided|||Data were compared between groups using a 2 sample T-test.||||0.31
71080394|NCT01402986|141667565|SUPERIORITY_OR_OTHER||Rate Ratio|0.94||||0.709|TWO_SIDED|95.0|0.67|1.31|||Poisson regression|||The 95 percent (%) confidence interval (CI) for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 versus \[vs\] more than \[\>\] 2 but less than or equal to \[=\<\] 6), atopic asthma status (atopic/non-atopic), chronic oral corticosteroid (OCS) use (presence vs absence) and geographical region as the covariates.||1.31|0.67|0.709
71080395|NCT01402986|141667565|SUPERIORITY_OR_OTHER||Rate Ratio|1.02||||0.904|TWO_SIDED|95.0|0.71|1.46|||Poisson regression|||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \> 2 but =\< 6), atopic asthma status (atopic/non-atopic), chronic OCS use (presence vs absence) and geographical region as the covariates.||1.46|0.71|0.904
71080396|NCT01402986|141667582|SUPERIORITY_OR_OTHER||Rate Ratio|0.62||||0.293|TWO_SIDED|95.0|0.26|1.51|||Poisson regression|||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status (atopic/non-atopic), chronic OCS use (presence vs absence) and geographical region as the covariates.||1.51|0.26|0.293
71118980|NCT00395291|141742923|SUPERIORITY_OR_OTHER|||||||0.875|||||||ANCOVA|The esterase data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in esterase is the same for both the MK-0677 and placebo interventions.~Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted."||||0.875
71118981|NCT00395291|141742924|SUPERIORITY_OR_OTHER|||||||0.545|||||||ANCOVA|The adiponectin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in adiponectin is the same for both the MK-0677 and placebo interventions.~Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted."||||0.545
71118982|NCT00395291|141742925|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANCOVA|Total ghrelin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in Total-Ghrelin is the same for both the MK-0677 and placebo interventions.~Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted."||||0.900
71118983|NCT01468207|141742928|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|15.9|||=|0.003|TWO_SIDED|95.0|5.3|26.5||P-value adjusted for baseline Hurley Stage.|Cochran-Mantel-Haenszel|||||26.5|5.3|=0.003
71118984|NCT01468207|141742928|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.8|||=|0.048|TWO_SIDED|95.0|0.3|29.3|||Chi-squared|||||29.3|0.3|=0.048
71118985|NCT01468207|141742928|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|17.1|||=|0.027|TWO_SIDED|95.0|2.2|32.1|||Chi-squared|||||32.1|2.2|=0.027
71118986|NCT01468207|141742929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|||=|0.961|TWO_SIDED|95.0|-13.4|14.1|||Chi-squared|||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.||14.1|-13.4|=0.961
70854827|NCT02660138|141198071|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|84.81|||<|0.0001|TWO_SIDED|95.0|43.73|125.89|||MMRM|||Treatment group, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (total volume per void) as fixed effect variables, and subject as a random effect.||125.89|43.73|<0.0001
71118987|NCT01468207|141742930|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|2.8|||=|0.628|TWO_SIDED|95.0|-8.6|14.2||P-value adjusted for baseline Hurley Stage.|Cochran-Mantel-Haenszel|||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.||14.2|-8.6|=0.628
71118988|NCT01468207|141742931|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.7|||=|0.124|TWO_SIDED|95.0|-19.7|2.4|||ANCOVA|P-value calculated from ANCOVA with stratum, baseline, and treatment as covariates.||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.||2.4|-19.7|=0.124
71118989|NCT01328041|141742933|SUPERIORITY_OR_OTHER||T distribution|-1.432|||<|0.001|TWO_SIDED|95.0|-1.52|-1.343||The P value was derived by the null hypothesis testing of no change from Baseline in HIV-1 RNA at Day 8 at the two-sided 5% significance level using a single sample t-test.|t-test, 2 sided|||||-1.343|-1.520|<0.001
71118990|NCT01328041|141742934|SUPERIORITY_OR_OTHER||percentage of participants|69.0|||||TWO_SIDED|95.0|62.0|76.0|||||The estimated value represents the percentage of participants with HIV-1 RNA less than 50 copies/mL at Week 24.|||76|62|
71118991|NCT01328041|141742935|SUPERIORITY_OR_OTHER||percentage of participants|63.0|||||TWO_SIDED|95.0|56.0|70.0|||||The estimated value represents the percentage of participants with HIV-1 RNA less than 50 copies/mL at Week 48.|||70|56|
71118992|NCT00322023|141742970|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|These are paired t test baseline vs final for the 30 mg/kg dose||||||<0.0001
71118993|NCT00322023|141742970|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|These are paired t test baseline vs final for the 60 mg/kg dose||||||<0.05
71118994|NCT00322023|141742970|SUPERIORITY|These are paired t test baseline vs final for the 120 mg/kg dose|||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71118995|NCT00322023|141742971|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39|TWO_SIDED|95.0||||These are paired t test baseline vs final for 30mg/kg|t-test, 2 sided|||||||0.39
71118996|NCT00322023|141742971|SUPERIORITY||||||<|0.001||||||These are paired t test baseline vs final for 60mg/kg|t-test, 2 sided|||||||<0.001
71118997|NCT00322023|141742971|SUPERIORITY|||||||0.01||||||These are paired t test baseline vs final for 120mg/kg|t-test, 2 sided|||||||0.01
71080397|NCT01402986|141667582|SUPERIORITY_OR_OTHER||Rate Ratio|0.62||||0.27|TWO_SIDED|95.0|0.27|1.44|||Poisson regression|||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status (atopic/non-atopic), chronic OCS use (presence vs absence) and geographical region as the covariates.||1.44|0.27|0.270
71118998|NCT01180036|141743007|SUPERIORITY||Risk Difference (RD)|40.0||||0.001|TWO_SIDED|95.0|24.6|55.4|||Chi-squared|||||55.4|24.6|0.001
70943398|NCT01287416|141387111|SUPERIORITY_OR_OTHER|||||||0.46||95.0||||A priori threshold for significance set at p\<.05.|ANCOVA|Model was adjusted for differences in educational attainment at baseline.||Null hypothesis was that the groups would not differ in terms of alcohol use across the two time points.||||0.46
71080398|NCT01402986|141667583|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.257|TWO_SIDED|95.0|0.57|1.16|||Regression, Cox|||||1.16|0.57|0.257
71118999|NCT01180036|141743008|NON_INFERIORITY|With a non-inferiority margin of 15%. enrollment of 63 evaluable patients per study are is required to achieve 80% power to show that RTX is not inferior.||||||0.009|||||||Chi-squared|||||||0.009
71119000|NCT04243577|141743009|EQUIVALENCE|Margins for this test were calculated as plus or minus half a standard deviation using preliminary data acquired with the conventional electrodes, which were considered as the current gold standard and were ± 3.1.|||||<|0.025||||||Alpha level based on Bonferroni correction was set to .025 to correct for multiple comparisons.|t-test, 2 sided|||For Iteration 1 testing, we hypothesized that normalized amplitude during swallow trials obtained using the conventional sensors and the experimental sensors will be equivalent. Alpha level was set to .025 to correct for multiple comparisons.||||<0.025
71119001|NCT04243577|141743009|EQUIVALENCE|Margins for this test were based on the absolute value of the effect size (Cohen's d) being smaller than 0.5.|||||<|0.025||||||Alpha level based on Bonferroni correction was set to .025 to correct for multiple comparisons.|Bootstrapping CIs|In this 2nd iteration testing, we are accounting for variance uncertainty, and thus bootstrapping a Confidence Interval for Cohen's d.||For Iteration 2 testing again, we hypothesized that normalized amplitude during swallow trials obtained using the conventional sensors and the experimental sensors will be equivalent. Alpha level was set to .025 to correct for multiple comparisons.||||<0.025
71119002|NCT04243577|141743010|NON_INFERIORITY|Margin for this test was calculated as minus half a standard deviation using preliminary data acquired with the conventional electrodes, which were considered as the current gold standard and was -.99.|||||<|0.025||||||Alpha level based on Bonferroni correction was set to .025 to correct for multiple comparisons.|t-test, 1 sided|||For Iteration 1 testing, we hypothesized that Signal to Noise Ratio (SNR) obtained using the experimental sensors will not be inferior to the Signal to Noise Ratio (SNR) obtained using the conventional sensors. Alpha level was set to .025 to correct for multiple comparisons.||||<0.025
71119003|NCT04243577|141743010|NON_INFERIORITY|Margin for this test was based on the effect size (Cohen's d) being larger than -0.5.|||||<|0.025||||||Alpha level based on Bonferroni correction was set to .025 to correct for multiple comparisons.|Bootstrapping CIs|In this 2nd iteration testing, we are accounting for variance uncertainty, and thus bootstrapping a one-sided confidence bound for Cohen's d.||For Iteration 2 testing, we again hypothesized that Signal to Noise Ratio (SNR) obtained using the newer version of the experimental sensors will not be inferior to the Signal to Noise Ratio (SNR) obtained using the conventional sensors. Alpha level was set to .025 to correct for multiple comparisons.||||<0.025
71119004|NCT04243577|141743011|SUPERIORITY||||||<|0.05|||||||t-test, 1 sided|Paired t-test||For Iteration 1 testing, we hypothesized that ease of use/comfort expressed after using the experimental patch will be higher than the one reported using the conventional electrodes. Alpha level was set to .05.||||<0.05
71119005|NCT04243577|141743011|SUPERIORITY||||||<|0.05|||||||t-test, 1 sided|Paired t-test||For Iteration 2 testing, again we hypothesized that ease of use/comfort expressed after using the experimental patch will be higher than the one reported using the conventional electrodes. Alpha level was set to .05.||||<0.05
71119006|NCT01679600|141743013|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||F1-LD-F1 model by Brunner and Langer|||||||0.53
71119007|NCT01685801|141743014|SUPERIORITY_OR_OTHER||Posterior Mean|2.251|STANDARD_DEVIATION|0.961|||TWO_SIDED|95.0|0.383|4.144|||||The posterior distribution of overall treatment difference was obtained using the Bayesian hierarchical model and 95% credible interval of the treatment effect (posterior mean) was calculated.|"This statistical analysis is for Overall category."||4.144|0.383|
71119008|NCT04686084|141743036|OTHER|Bland-Altman analysis|Median Difference (Final Values)|0.04|||||TWO_SIDED|||||||||||||
71119009|NCT04452435|141743063|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.4891|||||||ANCOVA|||||||=0.4891
70943399|NCT01287416|141387112|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||The a priori threshold for statistical significance was set at p\<.05.|ANCOVA|Model is adjusted for differences in educational attainment at baseline.||The null hypothesis was that the two groups would not differ in resiliency scores across the follow-up period.||||0.28
71080399|NCT01402986|141667583|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.225|TWO_SIDED|95.0|0.56|1.15|||Regression, Cox|||||1.15|0.56|0.225
71080400|NCT01402986|141667584|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.538|TWO_SIDED|95.0|0.37|1.68|||Regression, Cox|||||1.68|0.37|0.538
71080401|NCT01402986|141667584|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.561|TWO_SIDED|95.0|0.37|1.71|||Regression, Cox|||||1.71|0.37|0.561
71119010|NCT04452435|141743063|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.0881|||||||ANCOVA|||A subgroup analyses was performed in subjects with supplemental oxygen use at baseline. A total of 26 subjects in the C21 group and 27 in the placebo group were included in the analysis of change in CRP from baseline to the mean of the last 2 non-missing scheduled assessments during the treatment period by baseline supplemental oxygen use.||||=0.0881
71119011|NCT04452435|141743064|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.0492|||||||ANCOVA|||||||=0.0492
70943400|NCT01287416|141387113|SUPERIORITY_OR_OTHER|||||||0.33||95.0||||A priori threshold for significance set at p\<.05.|Chi-squared|||||||0.33
70943401|NCT01287416|141387114|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||A priori threshold for significance set at p\<.05.|Chi-squared|||||||0.62
71119012|NCT04452435|141743065|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.9923|||||||ANCOVA|||||||=0.9923
71119013|NCT04452435|141743066|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.5355|||||||ANCOVA|||||||=0.5355
71119014|NCT04452435|141743067|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.4738|||||||ANCOVA|||||||=0.4738
71119015|NCT04452435|141743068|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.9418|||||||ANCOVA|||||||=0.9418
71119016|NCT04452435|141743069|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.9733|||||||ANCOVA|||||||=0.9733
71119017|NCT04452435|141743070|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.0568|||||||Regression, Logistic|||||||=0.0568
71119018|NCT04452435|141743071|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.6088|||||||Regression, Logistic|||||||=0.6088
71119019|NCT04452435|141743072|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.5757|||||||Log Rank|||||||=0.5757
71119020|NCT04452435|141743073|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.8588|||||||Wilcoxon (Mann-Whitney)|||||||=0.8588
71119021|NCT04452435|141743075|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.003|||||||Chi-squared|||||||=0.003
71119022|NCT01155466|141743084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.87|TWO_SIDED|95.0|-0.62|0.53|||Mixed Models Analysis||"The estimated parameter is the difference in the estimated mean change from baseline in mean off time for preladenant 10 mg - placebo."|||0.53|-0.62|0.8700
71119023|NCT01155466|141743086|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.6||||0.899|TWO_SIDED|95.0|-7.3|1.6|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with diastolic blood pressure \>=105 mm Hg for preladenant 2 mg - placebo|||1.6|-7.3|0.899
71119024|NCT01155466|141743086|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.9||||0.815|TWO_SIDED|95.0|-6.8|2.6|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with diastolic blood pressure \>=105 mm Hg for preladenant 5 mg - placebo|||2.6|-6.8|0.815
71119025|NCT01155466|141743086|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.4||||0.295|TWO_SIDED|95.0|-3.9|6.9|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with diastolic blood pressure \>=105 mm Hg for preladenant 10 mg - placebo|||6.9|-3.9|0.295
71119026|NCT01155466|141743089|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.6||||0.629|TWO_SIDED|95.0|-5.1|3.7|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with suicidality for preladenant 2 mg - placebo|||3.7|-5.1|0.629
71119027|NCT01155466|141743089|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.6||||0.625|TWO_SIDED|95.0|-5.1|3.7|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with suicidality for preladenant 5 mg - placebo|||3.7|-5.1|0.625
71119028|NCT01155466|141743089|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.6||||0.948|TWO_SIDED|95.0|-6.8|0.7|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with suicidality for preladenant 10 mg - placebo|||0.7|-6.8|0.948
71119029|NCT01155466|141743090|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1||||0.7044|TWO_SIDED|95.0|-0.61|0.9|||Constrained longitudinal data analysis||The estimated parameter is the difference in the change from baseline in mean ESS score for preladenant 2 mg - placebo|||0.90|-0.61|0.7044
70943402|NCT01287416|141387115|SUPERIORITY_OR_OTHER|||||||1||95.0||||A priori threshold for significance set to p\<.05.|Fisher Exact|||||||1.00
70943403|NCT01287416|141387116|SUPERIORITY_OR_OTHER|||||||1||95.0||||A priori threshold for significance set to p\<.05.|Fisher Exact|||||||1.00
70943404|NCT01287416|141387117|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||A priori threshold for significance set to p\<.05.|Fisher Exact|||||||0.064
71080402|NCT01402986|141667585|SUPERIORITY_OR_OTHER||Rate Ratio|0.73||||0.19|TWO_SIDED|95.0|0.46|1.17|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \>= median||1.17|0.46|0.190
70943405|NCT01287416|141387119|SUPERIORITY_OR_OTHER|||||||0.14||95.0||||a priori threshold for significance set a p\<.05.|Fisher Exact|unadjusted model||Null hypothesis was that the groups would not differ in terms of their gatekeeper behaviours||||0.14
70943406|NCT01287416|141387120|SUPERIORITY_OR_OTHER|||||||0.41||95.0||||A priori threshold for significance set at p\<.05.|Chi-squared|Unadjusted model||Null hypothesis was that the groups would not differ on gatekeeper behaviours.||||0.41
70943407|NCT02269917|141387184|NON_INFERIORITY|4|Difference in percentage|0.4|||<|0.001|TWO_SIDED|95.0|-1.5|2.2|||Stratum-adjusted Mantel-Haenszel (MH)|||||2.2|-1.5|<0.001
70943408|NCT02269917|141387189|OTHER||Least Square (LS) Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.623|=|0.58|TWO_SIDED|95.0|-0.88|1.57|||ANCOVA|||Change at Week 24||1.57|-0.88|=0.580
70943409|NCT02269917|141387189|OTHER||Least Square (LS) Mean Difference|0.62|STANDARD_ERROR_OF_MEAN|0.646|=|0.34|TWO_SIDED|95.0|-0.65|1.88|||ANCOVA|||Change at Week 48||1.88|-0.65|=0.340
71119030|NCT01155466|141743090|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.4||||0.3439|TWO_SIDED|95.0|-0.4|1.14|||Constrained longitudinal data analysis||The estimated parameter is the difference in the change from baseline in mean ESS score for preladenant 5 mg - placebo|||1.14|-0.4|0.3439
71119031|NCT01155466|141743090|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.3||||0.3941|TWO_SIDED|95.0|-0.43|1.08|||Constrained longitudinal data analysis||The estimated parameter is the difference in the change from baseline in mean ESS score for preladenant 10 mg - placebo|||1.08|-0.43|0.3941
71119032|NCT01155466|141743091|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.994||||0.983|TWO_SIDED|95.0|0.597|1.657|||Mixed Models Analysis|Odds ratio was calculated for all randomized and treated participants with at least 1 post treatment value.|"Confidence intervals and P-values were based on a generalized linear mixed model with baseline average off time as a covariate and treatment-by-time interaction as fixed effect and participant as random effect."|||1.657|0.597|0.983
71119033|NCT01155466|141743092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.6405|TWO_SIDED|95.0|-0.49|0.8|||Mixed Models Analysis||"The estimated parameter is the difference in the estimated change from baseline in on time without troublesome dyskinesias for preladenant 10 mg - placebo."|||0.80|-0.49|0.6405
71119034|NCT03119181|141743094|SUPERIORITY|||||||0.0097|||||||one-sided permutation test|||one-sided permutation test at 2.5% significance||||0.0097
71119035|NCT00557310|141743109|SUPERIORITY_OR_OTHER|||||||0.363||95.0|||||Mixed Model Repeated Measurements|||||||0.363
71119036|NCT00557310|141743110|SUPERIORITY_OR_OTHER|||||||0.837||95.0|||||Mixed Model Repeated Measurements|||||||0.837
70943410|NCT02269917|141387190|OTHER||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.874|=|0.506|TWO_SIDED|95.0|-2.3|1.13|||ANCOVA|||Change at Week 24||1.13|-2.30|=0.506
70943411|NCT02269917|141387190|OTHER||LS Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.862|=|0.392|TWO_SIDED|95.0|-2.43|0.95|||ANCOVA|||Change Week 48||0.95|-2.43|=0.392
71119037|NCT00557310|141743111|SUPERIORITY_OR_OTHER|||||||0.816||95.0||||P-value is for the percent change from baseline at 18 months.|Mixed Model Repeated Measurements|||||||0.816
71119038|NCT00557310|141743111|SUPERIORITY_OR_OTHER|||||||0.934||95.0||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measurements|||||||0.934
71119039|NCT00557310|141743112|SUPERIORITY_OR_OTHER|||||||0.324||95.0||||P-value is for the percent change from baseline at 18 months.|Mixed Model Repeated Measures|||||||0.324
71119040|NCT00557310|141743112|SUPERIORITY_OR_OTHER|||||||0.089||95.0||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measures|||||||0.089
71119041|NCT00557310|141743113|SUPERIORITY_OR_OTHER|||||||0.847||95.0|||||Mixed Model Repeated Measurements|P-value is for the percent change from baseline at 18 months.||||||0.847
71119042|NCT00557310|141743113|SUPERIORITY_OR_OTHER|||||||0.212||95.0||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measurements|||||||0.212
71119043|NCT00557310|141743114|SUPERIORITY_OR_OTHER|||||||0.335||95.0|||||Mixed Model Repeated Measurements|P-value is for the percent change from baseline at 3 months.||||||0.335
71119044|NCT00557310|141743114|SUPERIORITY_OR_OTHER|||||||0.916||95.0||||P-value is for the percent change from baseline at 6 months.|Mixed Model Repeated Measurements|||||||0.916
71119045|NCT00557310|141743114|SUPERIORITY_OR_OTHER|||||||0.61||95.0||||P-value is for the percent change from baseline at 12 months.|Mixed Model Repeated Measurements|||||||0.610
71119046|NCT00557310|141743114|SUPERIORITY_OR_OTHER|||||||0.363||95.0|||||Mixed Model Repeated Measurements|P-value is for the percent change from baseline at 18 months.||||||0.363
70943412|NCT02269917|141387191|OTHER||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.624|=|0.143|TWO_SIDED|95.0|-2.14|0.31|||ANCOVA|||Change at Week 24||0.31|-2.14|=0.143
70943413|NCT02269917|141387191|OTHER||LS Mean Difference|-1.09|STANDARD_ERROR_OF_MEAN|0.646|=|0.092|TWO_SIDED|95.0|-2.36|0.18|||ANCOVA|||Change at Week 48||0.18|-2.36|=0.092
70943414|NCT02269917|141387192|OTHER||LS Mean Difference|1.14|STANDARD_ERROR_OF_MEAN|0.59|=|0.054|TWO_SIDED|95.0|-0.02|2.29|||ANCOVA|||Change at Week 24||2.29|-0.02|=0.054
70943415|NCT02269917|141387192|OTHER||LS Mean Difference|1.34|STANDARD_ERROR_OF_MEAN|0.63|=|0.034|TWO_SIDED|95.0|0.1|2.57|||ANCOVA|||Change at Week 48||2.57|0.10|=0.034
70943416|NCT02269917|141387193|OTHER||||||<|0.001|||||||Van Elteren Test|||UACR - Change at Week 24||||<0.001
70943417|NCT02269917|141387193|OTHER||||||<|0.001|||||||Van Elteren Test|||UACR - Change at Week 48||||<0.001
70943418|NCT02269917|141387193|OTHER||||||<|0.001|||||||Van Elteren Test|||UPCR - Change at Week 24||||<0.001
70943419|NCT02269917|141387193|OTHER||||||<|0.001|||||||Van Elteren Test|||UPCR - Change at Week 48||||<0.001
70943420|NCT02269917|141387194|OTHER||||||<|0.001|||||||Van Elteren Test|||URBPCR: Change at Week 24||||<0.001
70943421|NCT02269917|141387194|OTHER||||||<|0.001|||||||Van Elteren Test|||URBPCR: Change at Week 48||||<0.001
70943422|NCT02269917|141387194|OTHER||||||<|0.001|||||||Van Elteren Test|||UB2MGCR: Change at Week 24||||<0.001
70943423|NCT02269917|141387194|OTHER||||||<|0.001|||||||Van Elteren Test|||UB2MGCR: Change at Week 48||||<0.001
70943424|NCT02269917|141387195|OTHER||||||=|0.288|||||||Van Elteren Test|||FEPO4 - Change at Week 24||||=0.288
70943425|NCT02269917|141387195|OTHER||||||=|0.148|||||||Van Elteren Test|||FEPO4 - Change at Week 48||||=0.148
71080403|NCT01402986|141667585|SUPERIORITY_OR_OTHER||Rate Ratio|0.95||||0.856|TWO_SIDED|95.0|0.56|1.61|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \>= median||1.61|0.56|0.856
71080404|NCT01402986|141667585|SUPERIORITY_OR_OTHER||Rate Ratio|1.13||||0.602|TWO_SIDED|95.0|0.71|1.81|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \< median||1.81|0.71|0.602
71080405|NCT01402986|141667585|SUPERIORITY_OR_OTHER||Rate Ratio|0.91||||0.703|TWO_SIDED|95.0|0.55|1.5|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \< median||1.50|0.55|0.703
71080406|NCT01402986|141667585|SUPERIORITY_OR_OTHER||Rate Ratio|0.86||||0.455|TWO_SIDED|95.0|0.58|1.28|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \>= 25th Percentile||1.28|0.58|0.455
71119047|NCT00557310|141743114|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measurements|||||||0.837
70943426|NCT02269917|141387206|OTHER||LS Mean Difference|1.37|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|0.697|2.037|||ANCOVA|||Spine BMD: Percent change at Week 24||2.037|0.697|<0.001
71080407|NCT01402986|141667585|SUPERIORITY_OR_OTHER||Rate Ratio|1.02||||0.929|TWO_SIDED|95.0|0.66|1.57|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \>= 25th Percentile||1.57|0.66|0.929
71080408|NCT01402986|141667585|SUPERIORITY_OR_OTHER||Rate Ratio|1.26||||0.507|TWO_SIDED|95.0|0.63|2.51|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \< 25th Percentile||2.51|0.63|0.507
71080409|NCT01402986|141667585|SUPERIORITY_OR_OTHER||Rate Ratio|0.91||||0.805|TWO_SIDED|95.0|0.44|1.89|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \< 25th Percentile||1.89|0.44|0.805
71080410|NCT01402986|141667585|SUPERIORITY_OR_OTHER||Rate Ratio|0.88||||0.716|TWO_SIDED|95.0|0.44|1.75|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \>= 75th Percentile||1.75|0.44|0.716
71080411|NCT01402986|141667585|SUPERIORITY_OR_OTHER||Rate Ratio|1.51||||0.328|TWO_SIDED|95.0|0.66|3.43|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \>= 75th Percentile||3.43|0.66|0.328
71080412|NCT01402986|141667585|SUPERIORITY_OR_OTHER||Rate Ratio|0.95||||0.804|TWO_SIDED|95.0|0.64|1.41|||Poission regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \< 75th Percentile||1.41|0.64|0.804
71080413|NCT01402986|141667585|SUPERIORITY_OR_OTHER||Rate Ratio|0.7||||0.088|TWO_SIDED|95.0|0.47|1.05|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \< 75th Percentile||1.05|0.47|0.088
71080414|NCT01402986|141667586|SUPERIORITY_OR_OTHER||Rate Ratio|0.8||||0.365|TWO_SIDED|95.0|0.5|1.29|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 high||1.29|0.50|0.365
71080415|NCT01402986|141667586|SUPERIORITY_OR_OTHER||Rate Ratio|0.97||||0.922|TWO_SIDED|95.0|0.56|1.68|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 high||1.68|0.56|0.922
71080416|NCT01402986|141667586|SUPERIORITY_OR_OTHER||Rate Ratio|1.11||||0.685|TWO_SIDED|95.0|0.67|1.84|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 Low||1.84|0.67|0.685
71119048|NCT00557310|141743115|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71119049|NCT00557310|141743116|SUPERIORITY_OR_OTHER|||||||0.021||95.0|||||ANOVA|||||||0.021
71119050|NCT00557310|141743117|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71119051|NCT00557310|141743118|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||ANOVA|||||||0.045
71119052|NCT00557310|141743119|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for the percent change from baseline at 18 months.|ANOVA|||||||<0.001
71119053|NCT00557310|141743119|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for the percent change from baseline at 24 months.|ANOVA|||||||<0.001
70943427|NCT02269917|141387206|OTHER||LS Mean Difference|2.05|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|1.277|2.814|||ANCOVA|||Spine BMD: Percent change at Week 48||2.814|1.277|<0.001
70943428|NCT02269917|141387206|OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.272|=|0.001|TWO_SIDED|95.0|0.366|1.436|||ANCOVA|||Hip BMD: Percent change at Week 24||1.436|0.366|=0.001
71080417|NCT01402986|141667586|SUPERIORITY_OR_OTHER||Rate Ratio|1.06||||0.813|TWO_SIDED|95.0|0.66|1.7|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 Low||1.70|0.66|0.813
71080418|NCT01402986|141667587|SUPERIORITY_OR_OTHER||Rate Ratio|0.82||||0.335|TWO_SIDED|95.0|0.56|1.22|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \>=150 cells/mcgL||1.22|0.56|0.335
71080419|NCT01402986|141667587|SUPERIORITY_OR_OTHER||Rate Ratio|0.88||||0.586|TWO_SIDED|95.0|0.54|1.41|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \>=150 cells/mcgL||1.41|0.54|0.586
71080420|NCT01402986|141667587|SUPERIORITY_OR_OTHER||Rate Ratio|1.36||||0.331|TWO_SIDED|95.0|0.73|2.52|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \<150 cells/mcgL||2.52|0.73|0.331
71080421|NCT01402986|141667587|SUPERIORITY_OR_OTHER||Rate Ratio|1.41||||0.311|TWO_SIDED|95.0|0.73|2.71|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \<150 cells/mcgL||2.71|0.73|0.311
71080422|NCT01402986|141667587|SUPERIORITY_OR_OTHER||Rate Ratio|0.81||||0.414|TWO_SIDED|95.0|0.48|1.35|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \>=300 cells/mcgL||1.35|0.48|0.414
71080423|NCT01402986|141667587|SUPERIORITY_OR_OTHER||Rate Ratio|1.26||||0.463|TWO_SIDED|95.0|0.68|2.36|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \>=300 cells/mcgL||2.36|0.68|0.463
71080424|NCT01402986|141667587|SUPERIORITY_OR_OTHER||Rate Ratio|1.06||||0.793|TWO_SIDED|95.0|0.67|1.68|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \<300 cells/mcgL||1.68|0.67|0.793
71080425|NCT01402986|141667587|SUPERIORITY_OR_OTHER||Rate Ratio|0.77||||0.264|TWO_SIDED|95.0|0.49|1.22|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \<300 cells/mcgL||1.22|0.49|0.264
71080426|NCT01402986|141667588|SUPERIORITY_OR_OTHER||Rate Ratio|0.66||||0.245|TWO_SIDED|95.0|0.33|1.32|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \>=12%||1.32|0.33|0.245
71080427|NCT01402986|141667588|SUPERIORITY_OR_OTHER||Rate Ratio|0.76||||0.438|TWO_SIDED|95.0|0.37|1.54|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \>=12%||1.54|0.37|0.438
71080428|NCT01402986|141667588|SUPERIORITY_OR_OTHER||Rate Ratio|1.01||||0.947|TWO_SIDED|95.0|0.66|1.57|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \<12%||1.57|0.66|0.947
70943429|NCT02269917|141387206|OTHER||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|1.144|2.248|||ANCOVA|||Hip BMD: Percent change at Week 48||2.248|1.144|<0.001
71080429|NCT01402986|141667588|SUPERIORITY_OR_OTHER||Rate Ratio|0.97||||0.916|TWO_SIDED|95.0|0.59|1.59|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \<12%||1.59|0.59|0.916
71080430|NCT01402986|141667589|SUPERIORITY_OR_OTHER||Rate Ratio|0.91||||0.723|TWO_SIDED|95.0|0.52|1.56|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1% predicted \<=60%||1.56|0.52|0.723
71080431|NCT01402986|141667589|SUPERIORITY_OR_OTHER||Rate Ratio|1.06||||0.852|TWO_SIDED|95.0|0.6|1.86|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1% predicted \<=60%||1.86|0.60|0.852
71080432|NCT01402986|141667589|SUPERIORITY_OR_OTHER||Rate Ratio|0.86||||0.409|TWO_SIDED|95.0|0.6|1.23|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1% predicted \<=80%||1.23|0.60|0.409
70943430|NCT02825849|141387290|SUPERIORITY|||||||0.824|||||||Chi-squared|||||||.824
70943431|NCT01064856|141387295|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|||||||Pearson's chi-square|||||||0.006
70943432|NCT01064856|141387297|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|The P-value was based on an ANCOVA model adjusting for baseline with treatment as a factor.||||||<0.001
70943433|NCT01064856|141387298|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||ANCOVA|The P-value was based on an ANCOVA model adjusting for baseline with treatment as a factor.||||||0.003
70943434|NCT01064856|141387299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.051|||||||ANCOVA|The P-value was based on an ANCOVA model adjusting for baseline with treatment as a factor.||||||0.051
70943435|NCT05294328|141387345|SUPERIORITY||Odds Ratio (OR)|34.262|||<|0.0001|TWO_SIDED||||||Generalized Estimating Equation (GEE)|||||||<0.0001
71080433|NCT01402986|141667589|SUPERIORITY_OR_OTHER||Rate Ratio|1.07||||0.744|TWO_SIDED|95.0|0.72|1.58|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1% predicted \<=80%||1.58|0.72|0.744
71080434|NCT01402986|141667590|SUPERIORITY_OR_OTHER||Rate Ratio|0.94||||0.802|TWO_SIDED|95.0|0.58|1.52|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|2 asthma exacerbations in the past year||1.52|0.58|0.802
71080435|NCT01402986|141667590|SUPERIORITY_OR_OTHER||Rate Ratio|0.6||||0.05|TWO_SIDED|95.0|0.36|1.0|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|2 asthma exacerbations in the past year||1.00|0.36|0.050
71080436|NCT01402986|141667590|SUPERIORITY_OR_OTHER||Rate Ratio|0.93||||0.792|TWO_SIDED|95.0|0.56|1.56|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|\> 2 but \< 6 asthma exacerbations in the past year||1.56|0.56|0.792
71080437|NCT01402986|141667590|SUPERIORITY_OR_OTHER||Rate Ratio|1.39||||0.231|TWO_SIDED|95.0|0.81|2.38|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|\> 2 but \< 6 asthma exacerbations in the past year||2.38|0.81|0.231
71080438|NCT01402986|141667591|SUPERIORITY_OR_OTHER||Rate Ratio|0.25||||0.046|TWO_SIDED|95.0|0.06|0.98|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline Serum Periostin \>=Median||0.98|0.06|0.046
71080439|NCT01402986|141667591|SUPERIORITY_OR_OTHER||Rate Ratio|0.47||||0.197|TWO_SIDED|95.0|0.15|1.48|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline Serum Periostin \>=Median||1.48|0.15|0.197
71080440|NCT01402986|141667591|SUPERIORITY_OR_OTHER||Rate Ratio|1.18||||0.708|TWO_SIDED|95.0|0.5|2.79|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline Serum Periostin \< Median||2.79|0.50|0.708
71119054|NCT00557310|141743120|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value is for the percent change from baseline at 18 months.|ANOVA|||||||0.011
71119055|NCT00557310|141743120|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||P-value is for the percent change from baseline at 24 months.|ANOVA|||||||0.049
71119056|NCT00557310|141743121|SUPERIORITY_OR_OTHER|||||||0.7||95.0||||P-value is for the percent change from baseline at 18 months.|ANOVA|||||||0.700
71119057|NCT00557310|141743121|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||P-value is for the percent change from baseline at 24 months.|ANOVA|||||||0.092
71119058|NCT00557310|141743122|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value is for the percent change from baseline at 18 months.|ANOVA|||||||0.013
71119059|NCT00557310|141743122|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value is for the percent change from baseline at 24 months.|ANOVA|||||||0.005
71119060|NCT00557310|141743123|SUPERIORITY_OR_OTHER|||||||0.106||95.0||||P-value is for the percent change from baseline at 18 months.|ANOVA|||||||0.106
71119061|NCT00557310|141743123|SUPERIORITY_OR_OTHER|||||||0.436||95.0||||P-value is for the percent change from baseline at 24 months.|ANOVA|||||||0.436
71119062|NCT00557310|141743124|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for the percent change from baseline at 3 months.|Mixed Model Repeated Measurements|||||||<0.001
71119063|NCT00557310|141743124|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for the percent change from baseline at 6 months.|Mixed Model Repeated Measurements|||||||<0.001
71119064|NCT00557310|141743124|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measurements|||||||<0.001
71119065|NCT00557310|141743125|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-value is for the percent change from baseline at 3 months.|Mixed Model Repeated Measurements|||||||0.012
71119066|NCT00557310|141743125|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-value is for the percent change from baseline at 6 months.|Mixed Model Repeated Measurements|||||||0.012
71119067|NCT00557310|141743125|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measurements|||||||0.016
71119068|NCT00367744|141743130|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Treatment groups were compared for change in limb fat using a two-sided signed rank test||The primary outcome measure was the change in limb fat at 48 weeks between the rosiglitazone and placebo group.||||0.02
71119069|NCT01271712|141743201|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-06|||||||Log Rank|stratified||The two treatment groups were compared using a stratified log rank test with a one-sided alpha of 0.01 stratified by (3rd vs 4th-line; and geographical region). The null hypothesis that both treatment arms have the same PFS distribution was tested against the alternative hypothesis that the distribution of PFS in the regorafenib arm is different from the control arm according to a proportional hazards relation between the treatment arms.||||<0.000001
70943436|NCT05294328|141387345|SUPERIORITY||Odds Ratio (OR)|73.443|||<|0.0001|TWO_SIDED||||||Generalized Estimating Equation (GEE)|||||||<0.0001
71080441|NCT01402986|141667591|SUPERIORITY_OR_OTHER||Rate Ratio|1.31||||0.594|TWO_SIDED|95.0|0.48|3.57|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline Serum Periostin \< Median||3.57|0.48|0.594
71080442|NCT01402986|141667592|SUPERIORITY_OR_OTHER||Rate Ratio|1.03||||0.975|TWO_SIDED|95.0|0.14|7.67|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \>=12%||7.67|0.14|0.975
71080443|NCT01402986|141667592|SUPERIORITY_OR_OTHER||Rate Ratio|1.66||||0.473|TWO_SIDED|95.0|0.41|6.67|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \>=12%||6.67|0.41|0.473
71080444|NCT01402986|141667592|SUPERIORITY_OR_OTHER||Rate Ratio|0.49||||0.099|TWO_SIDED|95.0|0.21|1.14|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \<12%||1.14|0.21|0.099
71080445|NCT01402986|141667592|SUPERIORITY_OR_OTHER||Rate Ratio|0.42||||0.148|TWO_SIDED|95.0|0.13|1.36|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \<12%||1.36|0.13|0.148
71080446|NCT01402986|141667593|SUPERIORITY_OR_OTHER||Rate Ratio|0.82||||0.698|TWO_SIDED|95.0|0.31|2.19|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 high||2.19|0.31|0.698
71080447|NCT01402986|141667593|SUPERIORITY_OR_OTHER||Rate Ratio|0.55||||0.299|TWO_SIDED|95.0|0.18|1.7|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 high||1.70|0.18|0.299
71080448|NCT01402986|141667593|SUPERIORITY_OR_OTHER||Rate Ratio|0.25||||0.105|TWO_SIDED|95.0|0.05|1.34|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 Low||1.34|0.05|0.105
71080449|NCT01402986|141667593|SUPERIORITY_OR_OTHER||Rate Ratio|0.7||||0.576|TWO_SIDED|95.0|0.2|2.47|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 Low||2.47|0.20|0.576
71080450|NCT01402986|141667594|SUPERIORITY_OR_OTHER||Rate Ratio|0.48||||0.133|TWO_SIDED|95.0|0.19|1.25|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \>=300 cells/mcgL||1.25|0.19|0.133
71080451|NCT01402986|141667594|SUPERIORITY_OR_OTHER||Rate Ratio|0.46||||0.241|TWO_SIDED|95.0|0.13|1.67|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \>=300 cells/mcgL||1.67|0.13|0.241
71080452|NCT01402986|141667594|SUPERIORITY_OR_OTHER||Rate Ratio|0.59||||0.51|TWO_SIDED|95.0|0.12|2.84|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \<300 cells/mcgL||2.84|0.12|0.510
71080453|NCT01402986|141667594|SUPERIORITY_OR_OTHER||Rate Ratio|0.74||||0.661|TWO_SIDED|95.0|0.19|2.85|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \<300 cells/mcgL||2.85|0.19|0.661
71080454|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|6.79||||0.057|TWO_SIDED|95.0|-0.21|13.79|||Repeated measure model|||Baseline serum periostin \>= median||13.79|-0.21|0.057
70943437|NCT02056873|141387346|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.05|ONE_SIDED||||||Wilcoxon (Mann-Whitney)|||"At 6 months post-surgery the YGTSS scores of each subjects is statistically tested against their baseline scores.~A decrease in this tic severity scale means that the severity of the tics have reduced.~Hence, we performed a superiority test, which statistically verifies if the reduction in the tic severity scale was meaningful."||||0.05
71080455|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.57||||0.874|TWO_SIDED|95.0|-6.54|7.68|||Repeated measure model|||Baseline serum periostin \>= median||7.68|-6.54|0.874
70943438|NCT04572997|141387356|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Signed-rank test||||||< 0.0001
71080456|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|7.37||||0.028|TWO_SIDED|95.0|0.8|13.95|||Repeated measure model|||Baseline serum periostin \< median||13.95|0.80|0.028
71080457|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|1.09||||0.745|TWO_SIDED|95.0|-5.48|7.66|||Repeated measure model|||Baseline serum periostin \< median||7.66|-5.48|0.745
71080458|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|7.12||||0.011|TWO_SIDED|95.0|1.66|12.58|||Repeated measure model|||Baseline serum periostin \>= 25th percentile||12.58|1.66|0.011
71080459|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.48||||0.863|TWO_SIDED|95.0|-5.93|4.97|||Repeated measure model|||Baseline serum periostin \>= 25th percentile||4.97|-5.93|0.863
71080460|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|6.24||||0.221|TWO_SIDED|95.0|-3.8|16.27|||Repeated measure model|||Baseline serum periostin \< 25th percentile||16.27|-3.80|0.221
71080461|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|8.58||||0.108|TWO_SIDED|95.0|-1.91|19.07|||Repeated measure model|||Baseline serum periostin \< 25th percentile||19.07|-1.91|0.108
71080462|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|9.89||||0.09|TWO_SIDED|95.0|-1.57|21.35|||Repeated measure model|||Baseline serum periostin \>= 75th percentile||21.35|-1.57|0.090
71119070|NCT01271712|141743201|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.268|||||TWO_SIDED|95.0|0.185|0.388|||Regression, Cox|stratified|regorafenib over placebo|Hazard ratio and its 95% CI (Confidence Interval) was based on stratified Cox Regression Model||0.388|0.185|
70943439|NCT04572997|141387361|OTHER||||||<|0.001|||||||Wilcoxon Signed-rank test|||||||< 0.001
71119071|NCT01271712|141743202|SUPERIORITY_OR_OTHER_LEGACY|||||||0.285777|||||||Log Rank|stratified||||||0.285777
71080463|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.7||||0.908|TWO_SIDED|95.0|-11.19|12.59|||Repeated measure model|||Baseline serum periostin \>= 75th percentile||12.59|-11.19|0.908
71080464|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|6.52||||0.013|TWO_SIDED|95.0|1.41|11.64|||Repeated measure model|||Baseline serum periostin \< 75th percentile||11.64|1.41|0.013
71119072|NCT01271712|141743202|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.909|||||TWO_SIDED|95.0|0.653|1.265|||Regression, Cox|stratified|regorafenib over control. 58 (87.9%) patients in placebo group and 91 (68.4%) patients in regorafenib had started open-label treatment with regorafenib before time of final database cutoff 08 Jun 2015.|Hazard ratio and its 95% CI was based on stratified Cox Regression Model||1.265|0.653|
71080465|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|1.23||||0.635|TWO_SIDED|95.0|-3.84|6.29|||Repeated measure model|||Baseline serum periostin \< 75th percentile||6.29|-3.84|0.635
71080466|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|8.89||||0.014|TWO_SIDED|95.0|1.84|15.94|||Repeated measure model|||Th2 high||15.94|1.84|0.014
71080467|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|3.91||||0.28|TWO_SIDED|95.0|-3.19|11.02|||Repeated measure model|||Th2 high||11.02|-3.19|0.280
71080468|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|3.22||||0.292|TWO_SIDED|95.0|-2.78|9.22|||Repeated measure model|||Th2 low||9.22|-2.78|0.292
71080469|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|-1.18||||0.691|TWO_SIDED|95.0|-6.99|4.64|||Repeated measure model|||Th2 low||4.64|-6.99|0.691
71080470|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|8.83||||0.004|TWO_SIDED|95.0|2.85|14.81|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 150 cells/μL||14.81|2.85|0.004
71080471|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|4.25||||0.177|TWO_SIDED|95.0|-1.92|10.43|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 150 cells/μL||10.43|-1.92|0.177
71080472|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|6.05||||0.159|TWO_SIDED|95.0|-2.39|14.5|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 150 cells/μL||14.50|-2.39|0.159
71080473|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.72||||0.857|TWO_SIDED|95.0|-8.63|7.18|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 150 cells/μL||7.18|-8.63|0.857
71080474|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|13.75||||0.002|TWO_SIDED|95.0|5.28|22.22|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 300 cells/μL||22.22|5.28|0.002
71080475|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|5.23||||0.243|TWO_SIDED|95.0|-3.56|14.02|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 300 cells/μL||14.02|-3.56|0.243
71080476|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|4.37||||0.144|TWO_SIDED|95.0|-1.5|10.24|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 300 cells/μL||10.24|-1.50|0.144
71080477|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.72||||0.804|TWO_SIDED|95.0|-5.01|6.46|||Baseline peripheral blood eosinophil cou|||Baseline peripheral blood eosinophil count \< 300 cells/μ||6.46|-5.01|0.804
71080478|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|11.19||||0.029|TWO_SIDED|95.0|1.15|21.23|||Repeated measure model|||Baseline FEV1 reversibility \>= 12%||21.23|1.15|0.029
71080479|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.72||||0.887|TWO_SIDED|95.0|-9.19|10.62|||Repeated measure model|||Baseline FEV1 reversibility \>= 12%||10.62|-9.19|0.887
71080480|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|7.67||||0.002|TWO_SIDED|95.0|2.76|12.59|||Repeated measure model|||Baseline FEV1 reversibility \< 12%||12.59|2.76|0.002
71119073|NCT01271712|141743203|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-06|||||||Log Rank|stratified||||||<0.000001
71119074|NCT01271712|141743203|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.248|||||TWO_SIDED|95.0|0.17|0.364|||Regression, Cox|stratified||||0.364|0.170|
71119075|NCT04270682|141743231|EQUIVALENCE|The null (H0) hypothesis and the alternative (Ha) hypothesis to be tested for the primary efficacy endpoint are that H0: Δ = 0 versus Ha: Δ ≠ 0 where Δ is the true paired treatment difference between CDCA and placebo for the change from baseline in loge-transformed urine 23S-pentol in the adult cohort.|Mean Difference (Final Values)|-3.06|STANDARD_ERROR_OF_MEAN|0.332|<|0.0001|TWO_SIDED|95.0|-3.794|-2.331|||paired t-test|||||-2.331|-3.794|<0.0001
71119076|NCT04270682|141743232|EQUIVALENCE|The null (H0) hypothesis and the alternative (Ha) hypothesis to be tested for the primary efficacy endpoint are that H0: Δ = 0 versus Ha: Δ ≠ 0 where Δ is the true paired treatment difference between CDCA and placebo for the change from baseline in loge-transformed plasma cholestanol in the adult cohort.|Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.241||0.0083|TWO_SIDED|95.0|-1.64|-0.399|||paired t-test|||||-0.399|-1.640|0.0083
71119077|NCT04270682|141743233|EQUIVALENCE|The null (H0) hypothesis and the alternative (Ha) hypothesis to be tested for the primary efficacy endpoint are that H0: Δ = 0 versus Ha: Δ ≠ 0 where Δ is the true paired treatment difference between CDCA and placebo for the change from baseline in loge-transformed Plasma 7αC4 in the adult cohort.|Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|0.224|<|0.0001|TWO_SIDED|95.0|-4.193|-3.207|||paired t-test|||||-3.207|-4.193|<0.0001
71119078|NCT04270682|141743234|EQUIVALENCE|Exact 2 sided p-value for observing contingency tables of rescue data with equal or more extreme values is calculated using Prescott's method. Rejection of the null hypothesis for no association suggests there is a difference between two treatments.|proportion|0.077||||0.0006|TWO_SIDED|95.0|0.0|0.36|||Prescott's|||||0.36|0.00|0.0006
71119079|NCT04270682|141743234|EQUIVALENCE|Exact 2 sided p-value for observing contingency tables of rescue data with equal or more extreme values is calculated using Prescott's method. Rejection of the null hypothesis for no association suggests there is a difference between two treatments.|proportion|0.62||||0.0006|TWO_SIDED|95.0|0.32|0.86|||Prescott's|||||0.86|0.32|0.0006
71119080|NCT05479097|141743235|SUPERIORITY||Median Difference (Net)|-7.5||||0.03232|TWO_SIDED|95.0|-12.0|-1.0||A priori threshold for statistical significance was P \<0.05.|Wilcoxon signed rank test|Systolic blood pressure was not normally distributed in the study sample, so nonparametric analysis was used.||The null hypothesis was that there was no change in systolic blood pressure.||-1.0|-12.0|0.03232
71119081|NCT05479097|141743236|SUPERIORITY||Mean Difference (Net)|-3.1||||0.045|TWO_SIDED|95.0|-6.1|-0.1||The a priori threshold for statistical significance was P \<0.05.|t-test, 2 sided|As diastolic blood pressure was normally distributed in our sample, we used a paired t-test to evaluate the mean difference in measurements.||The null hypothesis was that there was no change in diastolic blood pressure.||-0.1|-6.1|0.045
71119082|NCT05479097|141743237|SUPERIORITY|||||||0.7237||||||The a priori threshold for statistical significance was P \<0.05|McNemar|||The null hypothesis was no change in the proportion of patients with systolic blood pressure well-controlled (\<=140 mmHg) from baseline to 6 months.||||0.7237
71119083|NCT05479097|141743238|SUPERIORITY|||||||0.7237||||||The a priori threshold for statistical significance was P \<0.05|McNemar|||The null hypothesis was that there was no difference in the proportion of patients with systolic blood pressure less than or equal to their personalized goal from baseline to 6 months.||||0.7237
71119084|NCT03894969|141743272|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% CI for the GMC ratio for anti-PD is \> 0.667. The anti-PD GMC ratio is presented in this test with its 95% CI.|GMC ratio|0.942|||||TWO_SIDED|0.95|0.765|1.159|||ANCOVA|ANCOVA model with treatment group, age category, smoking status and center as fixed effects and pre-Dose 1 log-concentration as a covariate.||To demonstrate the non-inferiority (NI) of the humoral immune response 1 month after Dose 2 of GSK Biologicals' NTHi-Mcat investigational vaccine when administered 1 after Shingrix vaccine versus the humoral immune response 1 month after Dose 2 of GSKBiologicals' NTHi-Mcat investigational vaccine alone.||1.159|0.765|
71119085|NCT03894969|141743272|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% CI for the GMC ratio for anti-PE is \> 0.667. The anti-PE GMC ratio is presented in this test with its 95% CI.|GMC ratio|0.887|||||TWO_SIDED|0.95|0.719|1.093|||ANCOVA|ANCOVA model with treatment group, age category, smoking status and center as fixed effects and pre-Dose 1 log-concentration as a covariate.||To demonstrate the non-inferiority (NI) of the humoral immune response 1 month after Dose 2 of GSK Biologicals' NTHi-Mcat investigational vaccine when administered 1 after Shingrix vaccine versus the humoral immune response 1 month after Dose 2 of GSKBiologicals' NTHi-Mcat investigational vaccine alone.||1.093|0.719|
71119086|NCT03894969|141743272|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% CI for the GMC ratio for anti-PilA is \> 0.667. The anti-PilA GMC ratio is presented in this test with its 95% CI.|GMC ratio|1.142|||||TWO_SIDED|0.95|0.884|1.474|||ANCOVA|ANCOVA model with treatment group, age category, smoking status and center as fixed effects and pre-Dose 1 log-concentration as a covariate.||To demonstrate the non-inferiority (NI) of the humoral immune response 1 month after Dose 2 of GSK Biologicals' NTHi-Mcat investigational vaccine when administered 1 after Shingrix vaccine versus the humoral immune response 1 month after Dose 2 of GSKBiologicals' NTHi-Mcat investigational vaccine alone.||1.474|0.884|
71119087|NCT03894969|141743272|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% CI for the GMC ratio for anti-UspA2 is \> 0.667. The anti-UspA2 GMC ratio is presented in this test with its 95% CI.|GMC ratio|1.087|||||TWO_SIDED|0.95|0.948|1.245|||ANCOVA|ANCOVA model with treatment group, age category, smoking status and center as fixed effects and pre-Dose 1 log-concentration as a covariate.||To demonstrate the non-inferiority (NI) of the humoral immune response 1 month after Dose 2 of GSK Biologicals' NTHi-Mcat investigational vaccine when administered 1 after Shingrix vaccine versus the humoral immune response 1 month after Dose 2 of GSKBiologicals' NTHi-Mcat investigational vaccine alone.||1.245|0.948|
70943440|NCT03443063|141387390|OTHER||Percent (%) ratio of geometric means|104.83|||||TWO_SIDED|90.0|77.41|141.97|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|||141.97|77.41|
70943441|NCT03443063|141387391|OTHER||Percent (%) ratio of geometric means|133.03|||||TWO_SIDED|90.0|107.3|164.93|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|||164.93|107.30|
70943442|NCT03443063|141387392|OTHER||Percent (%) ratio of geometric means|150.53|||||TWO_SIDED|90.0|113.16|200.26|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|||200.26|113.16|
70943443|NCT03443063|141387393|OTHER||Percent (%) ratio of geometric means|149.84|||||TWO_SIDED|90.0|113.06|198.58|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|||198.58|113.06|
70943444|NCT03443063|141387394|OTHER||Percent (%) ratio of geometric means|80.09|||||TWO_SIDED|90.0|56.07|114.4|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4||114.40|56.07|
70943445|NCT03443063|141387394|OTHER||Percent (%) ratio of geometric means|79.51|||||TWO_SIDED|90.0|54.48|116.03|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9||116.03|54.48|
70943446|NCT03443063|141387394|OTHER||Percent (%) ratio of geometric means|72.49|||||TWO_SIDED|90.0|48.08|109.29|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10||109.29|48.08|
71080481|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|2.79||||0.268|TWO_SIDED|95.0|-2.15|7.74|||Repeated measure model|||Baseline FEV1 reversibility \< 12%||7.74|-2.15|0.268
71080482|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|7.82||||0.003|TWO_SIDED|95.0|2.64|13.01|||Repeated measure model|||2 asthma exacerbations in the past year||13.01|2.64|0.003
71119088|NCT00468676|141743289|SUPERIORITY_OR_OTHER||scaled marginal model parameter|-1.57|STANDARD_ERROR_OF_MEAN|0.28||0.001|TWO_SIDED|95.0|-2.12|-1.02||Significance of the four outcome composite|Scaled Marginal Model||Intervention group had significantly lower scaled marginal mean scores than usual care|||-1.02|-2.12|.001
71119089|NCT00468676|141743290|SUPERIORITY_OR_OTHER||Slope|0.01|||<|0.01||95.0|||||general estimating equations|||Disability outcomes were measured at six and 12 months after randomization using linear regression models adjusted for baseline values. The disability models combined information across time points and were estimated using general estimating equations to account for correlation. All analyses were based on intent to treat principles||||<0.01
70943447|NCT03443063|141387396|OTHER||Percent (%) ratio of geometric mean|111.25|||||TWO_SIDED|90.0|91.69|134.99|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Lemborexant||134.99|91.69|
70943448|NCT03443063|141387396|OTHER||Percent (%) ratio of geometric means|80.28|||||TWO_SIDED|90.0|56.81|113.46|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4||113.46|56.81|
70943449|NCT03443063|141387396|OTHER||Percent (%) ratio of geometric means|86.71|||||TWO_SIDED|90.0|64.92|115.81|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9||115.81|64.92|
70943450|NCT03443063|141387396|OTHER||Percent (%) ratio of geometric means|65.38|||||TWO_SIDED|90.0|41.08|104.04|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10||104.04|41.08|
70943451|NCT03443063|141387397|OTHER||Percent (%) ratio of geometric means|114.69|||||TWO_SIDED|90.0|94.45|139.28|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4||139.28|94.45|
70943452|NCT03443063|141387397|OTHER||Percent (%) ratio of geometric means|124.94|||||TWO_SIDED|90.0|100.27|155.67|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9||155.67|100.27|
70943453|NCT03443063|141387397|OTHER||Percent (%) ratio of geometric means|92.05|||||TWO_SIDED|90.0|66.87|126.71|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10||126.71|66.87|
71080483|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|2.42||||0.361|TWO_SIDED|95.0|-2.78|7.62|||Repeated measure model|||2 asthma exacerbations in the past year||7.62|-2.78|0.361
71080484|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|6.34||||0.185|TWO_SIDED|95.0|-3.06|15.75|||Repeated measure model|||\> 2 but \< 6 asthma exacerbations in the past year||15.75|-3.06|0.185
71080485|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.08||||0.986|TWO_SIDED|95.0|-9.5|9.34|||Repeated measure model|||\> 2 but \< 6 asthma exacerbations in the past year||9.34|-9.50|0.986
71080486|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.87||||0.912|TWO_SIDED|95.0|-14.7|16.44|||Repeated measure model|||Chronic OCS use||16.44|-14.70|0.912
71080487|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|-1.46||||0.86|TWO_SIDED|95.0|-17.76|14.84|||Repeated measure model|||Chronic OCS use||14.84|-17.76|0.860
71080488|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|7.56||||0.002|TWO_SIDED|95.0|2.76|12.36|||Repeated measure model|||Without chronic OCS use||12.36|2.76|0.002
70943454|NCT03443063|141387398|OTHER||Percent (%) ratio of geometric means|136.28|||||TWO_SIDED|90.0|105.62|175.85|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4||175.85|105.62|
71080489|NCT01402986|141667595|SUPERIORITY_OR_OTHER||Difference of LS-mean|1.28||||0.601|TWO_SIDED|95.0|-3.51|6.06|||Repeated measure model|||Without chronic OCS use||6.06|-3.51|0.601
71080490|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.24||||0.145|TWO_SIDED|95.0|-0.57|0.08|||Repeated measure model|||Baseline serum periostin \>= median||0.08|-0.57|0.145
71080491|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.05||||0.759|TWO_SIDED|95.0|-0.28|0.38|||Repeated measure model|||Baseline serum periostin \>= median||0.38|-0.28|0.759
71119090|NCT00468676|141743292|SUPERIORITY_OR_OTHER||Estimated Between Group Difference|-0.41|||<|0.001|TWO_SIDED|95.0|-0.56|-0.26|||Generalized-Estimating-Equation Model||Between Group Difference is the difference in the change from Baseline to 12 month data calculated from a generalized-estimating-equation model predicting a 6- and 12-month outcome.|||-0.26|-0.56|<0.001
71119091|NCT00468676|141743293|SUPERIORITY_OR_OTHER||Estimated Between Group Difference|-3.4|||||TWO_SIDED|95.0|-6.9|0.1|||Generalized-Estimating-Equation Model||Between Group Difference is the difference in the change from Baseline to 12 month data calculated from a generalized-estimating-equation model predicting a 6- and 12-month outcome.|||0.1|-6.9|
71119092|NCT00468676|141743294|SUPERIORITY_OR_OTHER||Estimated Between Group Difference|-9.1|||||TWO_SIDED|95.0|-17.5|-0.8|||Regression, Linear||Between Group Difference is the difference in the change from Baseline to 12 month data calculated from a linear-regression model predicting a 12-month outcome.|||-0.8|-17.5|
71119093|NCT00468676|141743295|SUPERIORITY_OR_OTHER||Estimated Between Group Difference|-0.56|||||TWO_SIDED|95.0|-0.85|-0.27|||Generalized-Estimating-Equation Model||Between Group Difference is the difference in the change from Baseline to 12 month data calculated from a generalized-estimating-equation model predicting a 6- and 12-month outcome.|||-0.27|-0.85|
71119094|NCT03569748|141743296|NON_INFERIORITY|Margin=0.04|Proportion Difference|0.1342||||0.0051|TWO_SIDED|95.0|0.0014|0.2671|||Chi-squared, Corrected|||H0: P1-P2 ≤ -Margin||0.2671|0.0014|0.0051
71119095|NCT03569748|141743297|SUPERIORITY|||||||0.0003|||||||Fisher Exact|||||||0.0003
71119096|NCT03569748|141743298|SUPERIORITY||Percentage Difference|14.2||||0.0003|TWO_SIDED||||||Chi-squared, Corrected|||||||0.0003
71119097|NCT00118846|141743315|SUPERIORITY||Slope|-0.91||||0.35|TWO_SIDED|95.0|-2.86|1.05|||Mixed Models Analysis||Slope = Mean difference in annualized rate of change|||1.05|-2.86|0.35
71119098|NCT00118846|141743316|OTHER||Mean Difference (Net)|0.11||||0.36|TWO_SIDED|95.0|-0.13|0.35|||ANCOVA|||||0.35|-0.13|0.36
71119099|NCT01574157|141743317|SUPERIORITY||Mean Difference (Final Values)|12.6|||||TWO_SIDED|95.0|-9.6|40.1||||||The primary analysis compared the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.||40.1|-9.6|
71119100|NCT01574157|141743318|SUPERIORITY||Mean Difference (Final Values)|-10.1|||||TWO_SIDED|95.0|-38.2|30.8||||||The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.||30.8|-38.2|
71119101|NCT01574157|141743319|SUPERIORITY||Mean Difference (Final Values)|-32.5|||||TWO_SIDED|95.0|-56.3|4.2||||||The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.||4.2|-56.3|
71119102|NCT01574157|141743320|SUPERIORITY||Mean Difference (Final Values)|7.7|||||TWO_SIDED|95.0|-15.1|36.5||||||The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.||36.5|-15.1|
71080492|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.01||||0.936|TWO_SIDED|95.0|-0.38|0.35|||Repeated measure model|||Baseline serum periostin \< median||0.35|-0.38|0.936
71080493|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.28||||0.127|TWO_SIDED|95.0|-0.64|0.08|||Repeated measure model|||Baseline serum periostin \< median||0.08|-0.64|0.127
71080494|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.13||||0.343|TWO_SIDED|95.0|-0.41|0.14|||Repeated measure model|||Baseline serum periostin\>= 25th percentile||0.14|-0.41|0.343
71080495|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.01||||0.928|TWO_SIDED|95.0|-0.29|0.27|||Repeated measure model|||Baseline serum periostin\>= 25th percentile||0.27|-0.29|0.928
71080496|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.23||||0.374|TWO_SIDED|95.0|-0.74|0.28|||Repeated measure model|||Baseline serum periostin \< 25th percentile||0.28|-0.74|0.374
71080497|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.29||||0.259|TWO_SIDED|95.0|-0.81|0.22|||Repeated measure model|||Baseline serum periostin \< 25th percentile||0.22|-0.81|0.259
71080498|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.37||||0.127|TWO_SIDED|95.0|-0.84|0.11|||Repeated measure model|||Baseline serum periostin \>= 75th percentile||0.11|-0.84|0.127
71080499|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.07||||0.775|TWO_SIDED|95.0|-0.56|0.42|||Repeated measure model|||Baseline serum periostin \>= 75th percentile||0.42|-0.56|0.775
71119103|NCT01574157|141743321|SUPERIORITY||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|-24.6|35.9||||||The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.||35.9|-24.6|
71119104|NCT01574157|141743322|SUPERIORITY||Mean Difference (Final Values)|3.37|||||TWO_SIDED|95.0|-0.05|6.79||||||The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.||6.79|-0.05|
71119105|NCT03955250|141743345|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71119106|NCT03955250|141743346|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|time||||||<0.05
71119107|NCT03955250|141743346|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|condition||||||>0.05
71119108|NCT03955250|141743347|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|time||||||>0.05
71119109|NCT03955250|141743347|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|condition||||||>0.05
71119110|NCT03955250|141743348|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|time||||||<0.05
71119111|NCT03955250|141743348|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|condition||||||>0.05
71080500|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.1||||0.512|TWO_SIDED|95.0|-0.38|0.19|||Repeated measure model|||Baseline serum periostin \< 75th percentile||0.19|-0.38|0.512
71080501|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.12||||0.404|TWO_SIDED|95.0|-0.4|0.16|||Repeated measure model|||Baseline serum periostin \< 75th percentile||0.16|-0.40|0.404
71080502|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.24||||0.181|TWO_SIDED|95.0|-0.59|0.11|||Repeated measure model|||Th2 high||0.11|-0.59|0.181
71080503|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.25||||0.161|TWO_SIDED|95.0|-0.6|0.1|||Repeated measure model|||Th2 high||0.10|-0.60|0.161
71080504|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.11||||0.54|TWO_SIDED|95.0|-0.47|0.25|||Repeated measure model|||Th2 low||0.25|-0.47|0.540
71080505|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.07||||0.674|TWO_SIDED|95.0|-0.42|0.27|||Repeated measure model|||Th2 low||0.27|-0.42|0.674
71080506|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.22||||0.154|TWO_SIDED|95.0|-0.52|0.08|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 150 cells/μL||0.08|-0.52|0.154
71080507|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.17||||0.271|TWO_SIDED|95.0|-0.48|0.13|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 150 cells/μ||0.13|-0.48|0.271
71080508|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.08||||0.725|TWO_SIDED|95.0|-0.51|0.36|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 150 cells/μL||0.36|-0.51|0.725
71080509|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.12||||0.559|TWO_SIDED|95.0|-0.53|0.28|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 150 cells/μL||0.28|-0.53|0.559
71080510|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.47||||0.019|TWO_SIDED|95.0|-0.87|-0.08|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 300 cells/μL||-0.08|-0.87|0.019
71080511|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.2||||0.348|TWO_SIDED|95.0|-0.61|0.21|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 300 cells/μL||0.21|-0.61|0.348
71080512|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.03||||0.855|TWO_SIDED|95.0|-0.35|0.29|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 300 cells/μL||0.29|-0.35|0.855
70943455|NCT03443063|141387398|OTHER||Percent (%) ratio of geometric means|154.29|||||TWO_SIDED|90.0|117.53|202.57|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9||202.57|117.53|
71119112|NCT02793817|141743351|SUPERIORITY||Difference in percentage of responders|8.3||||0.0105|TWO_SIDED|95.0|2.0|14.7||To account for multiplicity, a step-down testing procedure was applied, whereby inference for a test in the pre-defined hierarchy was dependent upon statistical significance having been demonstrated for the previous test in the hierarchy.|Chi-squared|Without adjustment for any covariates|Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|P-values were based on 2-sided chi-squared tests (unadjusted) wherein the a priori significance level was 0.05.||14.7|2.0|0.0105
71119113|NCT02793817|141743352|SUPERIORITY||Difference in percentage of responders|20.0|||<|0.0001|TWO_SIDED|95.0|11.6|28.4||To account for multiplicity, a step-down closed testing procedure was applied, whereby inference for a test in the pre-defined hierarchy was dependent upon statistical significance having been demonstrated for the previous test in the hierarchy.|Chi-squared|Without adjustment for any covariates|Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|P-values were based on 2-sided chi-squared test (unadjusted), wherein a priori significance level was 0.05||28.4|11.6|<0.0001
71119114|NCT02793817|141743353|SUPERIORITY||Difference in percentage of responders|17.1|||<|0.0001|TWO_SIDED|95.0|9.1|25.0||P-value was based on a 2-sided chi-squared test (unadjusted) wherein the a priori significance level was 0.0167 for each secondary endpoint. Overall alpha for all secondary endpoints was controlled at 0.05.|Chi-squared|Without adjustment for any covariates|Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|||25.0|9.1|<0.0001
71119115|NCT02793817|141743354|SUPERIORITY||Difference in percentage of responders|19.0|||<|0.0001|TWO_SIDED|95.0|11.0|26.9||P-value was based on a 2-sided chi-squared test (unadjusted) wherein the a priori significance level was 0.0167 for each secondary endpoint. Overall alpha for all secondary endpoints was controlled at 0.05.|Chi-squared|Without adjustment for any covariates|Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|||26.9|11.0|<0.0001
71119116|NCT02793817|141743355|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.0078|TWO_SIDED|95.0|-0.31|-0.05|||Chi-squared|Without adjustment for any covariates|Estimated Value is the between-group difference for change from BL.|P-value was based on a 2-sided chi-squared test (unadjusted) wherein the a priori significance level was 0.0167 for each secondary endpoint. Overall alpha for all secondary endpoints was controlled at 0.05.||-0.05|-0.31|0.0078
71119117|NCT02793817|141743356|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.0005|TWO_SIDED|95.0|-0.38|-0.11||P-values have no inferential value for post hoc evaluations.|Chi-squared|Without any adjustment for covariates|Estimated Value is the between-group difference in change from BL|||-0.11|-0.38|0.0005
71119118|NCT02793817|141743357|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.0169|TWO_SIDED|95.0|-0.28|-0.03||P-values have no inferential value for post hoc evaluations.|Chi-squared|Without adjustments for any covariates.|Estimated Value is the between-group difference for change from BL|||-0.03|-0.28|0.0169
71119119|NCT03222973|141743358|SUPERIORITY||Treatment Difference|0.15||||0.1479|TWO_SIDED|95.0|-0.05|0.35||P-values are based on the Mixed Model for Repeated Measures (MMRM) adjusted for background DMT group, baseline magnetization transfer ratio (MTR)/diffusion tensor imaging (DTI) category and baseline component assessments.|MMRM|||Over 72 weeks: Overall Response Score||0.35|-0.05|0.1479
71119120|NCT03222973|141743360|SUPERIORITY||Odds Ratio (OR)|1.08||||0.7682|TWO_SIDED|95.0|0.65|1.79||Odds ratio (active vs. placebo), 95% CI and p-value are based on logistic regression adjusted for background DMT group, baseline MTR/DTI category and baseline component assessments.|Regression, Logistic|||||1.79|0.65|0.7682
71119121|NCT03222973|141743361|SUPERIORITY||Odds Ratio (OR)|0.71||||0.2131|TWO_SIDED|95.0|0.41|1.22||Odds ratio (active vs. placebo), 95% CI and p-value are based on logistic regression adjusted for background DMT group, baseline MTR/DTI category and baseline component assessments.|Regression, Logistic|||||1.22|0.41|0.2131
71119122|NCT03222973|141743362|SUPERIORITY||Odds Ratio (OR)|0.81||||0.4654|TWO_SIDED|95.0|0.47|1.41||Odds ratio (active vs. placebo), 95% CI and p-value are based on logistic regression adjusted for background DMT group, baseline MTR/DTI category and baseline component assessments.|Regression, Logistic|||||1.41|0.47|0.4654
71080513|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.2||||0.203|TWO_SIDED|95.0|-0.5|0.11|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 300 cells/μL||0.11|-0.50|0.203
71080514|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.44||||0.055|TWO_SIDED|95.0|-0.89|0.01|||Repeated measure model|||Baseline FEV1 reversibility \>= 12%||0.01|-0.89|0.055
71080515|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.37||||0.104|TWO_SIDED|95.0|-0.82|0.08|||Repeated measure model|||Baseline FEV1 reversibility \>= 12%||0.08|-0.82|0.104
70943456|NCT03443063|141387398|OTHER||Percent (%) ratio of geometric means|118.54|||||TWO_SIDED|90.0|87.84|159.97|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10||159.97|87.84|
70943457|NCT03443063|141387399|OTHER||Percent (%) ratio of geometric means|138.62|||||TWO_SIDED|90.0|109.1|176.14|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4||176.14|109.10|
71080516|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.07||||0.652|TWO_SIDED|95.0|-0.37|0.23|||Repeated measure model|||Baseline FEV1 reversibility \< 12%||0.23|-0.37|0.652
71080517|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.02||||0.905|TWO_SIDED|95.0|-0.28|0.32|||Repeated measure model|||Baseline FEV1 reversibility \< 12%||0.32|-0.28|0.905
71080518|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.19||||0.198|TWO_SIDED|95.0|-0.49|0.1|||Repeated measure model|||2 asthma exacerbations in the past year||0.10|-0.49|0.198
71080519|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.18||||0.226|TWO_SIDED|95.0|-0.47|0.11|||Repeated measure model|||2 asthma exacerbations in the past year||0.11|-0.47|0.226
71080520|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.14||||0.513|TWO_SIDED|95.0|-0.56|0.28|||Repeated measure model|||\> 2 but \< 6 asthma exacerbations in the past year||0.28|-0.56|0.513
71080521|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.01||||0.974|TWO_SIDED|95.0|-0.43|0.42|||Repeated measure model|||\> 2 but \< 6 asthma exacerbations in the past year||0.42|-0.43|0.974
71080522|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.37||||0.226|TWO_SIDED|95.0|-0.97|0.23|||Repeated measure model|||Chronic OCS use||0.23|-0.97|0.226
71080523|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.15||||0.613|TWO_SIDED|95.0|-0.44|0.75|||Repeated measure model|||Chronic OCS use||0.75|-0.44|0.613
71119123|NCT03222973|141743363|SUPERIORITY||Odds Ratio (OR)|1.78||||0.0417|TWO_SIDED|95.0|1.02|3.11||Odds ratio (active vs. placebo), 95% CI and p-value are based on logistic regression adjusted for background DMT group, baseline MTR/DTI category and baseline component assessments.|Regression, Logistic|||||3.11|1.02|0.0417
71119124|NCT03222973|141743364|SUPERIORITY||Odds Ratio (OR)|1.35||||0.2908|TWO_SIDED|95.0|0.78|2.33||Odds ratio (active vs. placebo), 95% CI and p-value are based on logistic regression adjusted for background DMT group, baseline MTR/DTI category and baseline component assessments.|Regression, Logistic|||||2.33|0.78|0.2908
70943458|NCT03443063|141387399|OTHER||Percent (%) ratio of geometric means|147.03|||||TWO_SIDED|90.0|109.06|198.22|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9||198.22|109.06|
70943459|NCT03443063|141387399|OTHER||Percent (%) ratio of geometric means|136.42|||||TWO_SIDED|90.0|98.19|189.54|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10||189.54|98.19|
71080524|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.17||||0.198|TWO_SIDED|95.0|-0.43|0.09|||Repeated measure model|||Without chronic OCS use||0.09|-0.43|0.198
71080525|NCT01402986|141667596|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.19||||0.165|TWO_SIDED|95.0|-0.45|0.08|||Repeated measure model|||Without chronic OCS use||0.08|-0.45|0.165
71080526|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.23||||0.211|TWO_SIDED|95.0|-0.13|0.6|||Repeated measure model|||Baseline serum periostin \>= median||0.60|-0.13|0.211
71080527|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.16||||0.397|TWO_SIDED|95.0|-0.21|0.53|||Repeated measure model|||Baseline serum periostin \>= median||0.53|-0.21|0.397
71080528|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.19||||0.315|TWO_SIDED|95.0|-0.18|0.56|||Repeated Measure Model|||Baseline serum periostin \< median||0.56|-0.18|0.315
71080529|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.26||||0.166|TWO_SIDED|95.0|-0.11|0.63|||Repeated measure model|||Baseline serum periostin \< median||0.63|-0.11|0.166
71080530|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.17||||0.262||95.0|-0.13|0.47|||Repeated measure model|||Baseline serum periostin \>= 25th percentile||0.47|-0.13|0.262
71080531|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.14||||0.379|TWO_SIDED|95.0|-0.17|0.44|||Repeated measure model|||Baseline serum periostin \>= 25th percentile||0.44|-0.17|0.379
71080532|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.25||||0.387|TWO_SIDED|95.0|-0.32|0.81|||Repeated measure model|||Baseline serum periostin \< 25th percentile||0.81|-0.32|0.387
71080533|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.29||||0.303|TWO_SIDED|95.0|-0.26|0.84|||Repeated measure model|||Baseline serum periostin \< 25th percentile||0.84|-0.26|0.303
71080534|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.37||||0.127|TWO_SIDED|95.0|-0.84|0.11|||Repeated measure model|||Baseline serum periostin \>=75th percentile||0.11|-0.84|0.127
71080535|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.07||||0.775|TWO_SIDED|95.0|-0.56|0.42|||Repeated measure model|||Baseline serum periostin \>=75th percentile||0.42|-0.56|0.775
71080536|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.1||||0.512|TWO_SIDED|95.0|-0.38|0.19|||Repeated measure model|||Baseline serum periostin \< 75th percentile||0.19|-0.38|0.512
71080537|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.12||||0.404|TWO_SIDED|95.0|-0.4|0.16|||Repeated measure model|||Baseline serum periostin \< 75th percentile||0.16|-0.40|0.404
71080538|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.31||||0.102|TWO_SIDED|95.0|-0.06|0.69|||Repeated measure model|||Th2 high||0.69|-0.06|0.102
71080539|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.3||||0.116|TWO_SIDED|95.0|-0.08|0.68|||Repeated measure model|||Th2 high||0.68|-0.08|0.116
71080540|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.11||||0.54|TWO_SIDED|95.0|-0.47|0.25|||Repeated measure model|||Th2 low||0.25|-0.47|0.540
71080541|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.07||||0.674|TWO_SIDED|95.0|-0.42|0.27|||Repeated measure model|||Th2 low||0.27|-0.42|0.674
71119125|NCT02080481|141743376|SUPERIORITY_OR_OTHER||ratio of geometric means|0.68|||<|0.001|TWO_SIDED|95.0|0.61|0.76|||Regression, Linear|intraoperative management strategy was imbalanced between randomized groups and was adjusted for in the linear regression model.||||0.76|0.61|< 0.001
71119126|NCT02080481|141743377|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.56|TWO_SIDED|98.3|0.25|9.6|||Regression, Logistic|intraoperative management strategy was imbalanced between randomized groups and was adjusted for in the logistic regression model.|Odds ratio for Infiniti Plus versus conventional needle patients|||9.6|0.25|0.56
71119127|NCT02080481|141743378|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.13||||0.06|TWO_SIDED|98.3|0.01|1.78||Intraoperative management strategy was imbalanced between groups and adjusted for in the logistic regression model.|Regression, Logistic|||||1.78|0.01|0.06
71119128|NCT02080481|141743379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4||||0.74|TWO_SIDED|98.3|-7.7|14.6|||Regression, Linear|Intraoperative management strategy was imbalanced between randomized groups and adjusted for in the linear regression model.||||14.6|-7.7|0.74
71119129|NCT03895632|141743383|OTHER|A linear mixed-effects model was fit to assess the association between α (the slope of the Power Spectral Density (PSD) plot) and signal segment.|||||<|0.0001||||||p-value obtained form the Wald statistics of the linear mixed-effects model. The threshold for statistical signifiance was p=0.01.|Linear mixed-effects model|||The null hypothesis was that α (the slope of the Power Spectral Density (PSD) plot) is not related to signal segment (off-, approaching- and on-target).||||<0.0001
71119130|NCT03002818|141743429|SUPERIORITY||mean change|-108266.0||||0.091|TWO_SIDED|95.0|-235037.0|18504.0|||one-sample t-test|||sdITT (n=26): Change at Day 168 minus Baseline||18504|-235037|0.091
71119131|NCT03002818|141743429|SUPERIORITY||mean change|-98373.0||||0.152|TWO_SIDED|95.0|-235667.0|38921.0|||one-sample t-test|||mITT (n=24): Change at Day 168 minus Baseline||38921|-235667|0.152
71119132|NCT03002818|141743429|SUPERIORITY|||||||0.091|||||||paired t-test|||sdITT (n=26): Baseline vs. Day 168||||0.091
71119133|NCT03002818|141743429|SUPERIORITY|||||||0.152|||||||paired t-test|||mITT (n=24): Baseline vs. Day 168||||0.152
71119134|NCT03002818|141743430|SUPERIORITY|||||||0.461|||||||paired t-test|||sdITT (n=34): Baseline vs. Day 28||||0.461
71119135|NCT03002818|141743430|SUPERIORITY|||||||0.63|||||||paired t-test|||mITT (n=24): Baseline vs. Day 28||||0.630
71119136|NCT03002818|141743430|SUPERIORITY|||||||0.855|||||||paired t-test|||sdITT (n=32): Baseline vs. Day 84||||0.855
71119137|NCT03002818|141743430|SUPERIORITY|||||||0.75|||||||paired t-test|||mITT (n=24): Baseline vs. Day 84||||0.750
71119138|NCT03002818|141743431|SUPERIORITY||mean change|2.6|||||TWO_SIDED|95.0|2.063|3.137||||||sdITT: mean change Baseline minus Day 168||3.137|2.063|
71119139|NCT03002818|141743431|SUPERIORITY||mean change|2.82|||||TWO_SIDED|95.0|2.212|3.428||||||mITT: mean change Baseline minus Day 168||3.428|2.212|
71119140|NCT03002818|141743431|SUPERIORITY||||||<|0.001|||||||Paired Wilcoxon Test|||sdITT (n=37): Baseline vs. Day 168||||<0.001
71119141|NCT03002818|141743431|SUPERIORITY||||||<|0.001|||||||Paired Wilcoxon Test|||mITT (n=24): Baseline vs. Day 168||||<0.001
71119142|NCT03002818|141743431|SUPERIORITY||||||<|0.001|||||||Paired Wilcoxon Test|||sdITT (n=35): Baseline vs. Day 28||||<0.001
71119143|NCT03002818|141743431|SUPERIORITY||||||<|0.001|||||||Paired Wilcoxon Test|||mITT (n=22): Baseline vs. Day 28||||<0.001
71119144|NCT03002818|141743431|SUPERIORITY||||||<|0.001|||||||Paired Wilcoxon Test|||sdITT (n=36): Baseline vs. Day 84||||<0.001
71119145|NCT03002818|141743431|SUPERIORITY||||||<|0.001|||||||Paired Wilcoxon Test|||mITT (n=23): Baseline vs. Day 84||||<0.001
71119146|NCT03002818|141743432|SUPERIORITY||mean change|0.61|||||TWO_SIDED|95.0|-0.651|1.871||||||sdITT: mean change Baseline minus Day 168||1.871|-0.651|
71119147|NCT03002818|141743432|SUPERIORITY||mean change|0.74|||||TWO_SIDED|95.0|-0.608|2.088||||||mITT: mean change Baseline minus Day 168||2.088|-0.608|
71119148|NCT03002818|141743432|SUPERIORITY|||||||0.381|||||||Paired Wilcoxon Test|||sdITT (n=37): Baseline vs. Day 168||||0.381
71119149|NCT03002818|141743432|SUPERIORITY|||||||0.304|||||||Paired Wilcoxon Test|||mITT (n=24): Baseline vs. Day 168||||0.304
71119150|NCT03002818|141743432|SUPERIORITY|||||||0.014|||||||Paired Wilcoxon Test|||sdITT (n=35): Baseline vs. Day 28||||0.014
71119151|NCT03002818|141743432|SUPERIORITY|||||||0.278|||||||Paired Wilcoxon Test|||mITT (n=22): Baseline vs. Day 28||||0.278
71119152|NCT03002818|141743432|SUPERIORITY|||||||0.881|||||||Paired Wilcoxon Test|||sdITT (n=36): Baseline vs. Day 84||||0.881
71119153|NCT03002818|141743432|SUPERIORITY|||||||0.775|||||||Paired Wilcoxon Test|||sdITT (n=23): Baseline vs. Day 84||||0.775
71119154|NCT00100230|141743445|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis: standard power calculation of 20%; used 2-sided t-test||||||0.3|TWO_SIDED|||||Threshold for significance: p\<0.05|Mixed Models Analysis|||||||0.30
71119155|NCT00100230|141743446|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis: standard power calculation of 20%; used 2-sided t-test||||||0.27|TWO_SIDED|||||Threshold for significance: p\<0.05|Mixed Models Analysis|||||||0.27
71119156|NCT00100230|141743446|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis: standard power calculation of 20%; used 2-sided t-test||||||0.27|TWO_SIDED||||||Mixed Models Analysis|||||||0.27
71119157|NCT00100230|141743447|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis: standard power calculation of 20%; used 2-sided t-test||||||8e-06|TWO_SIDED|||||Threshold for significance: p\<0.05|Mixed Models Analysis|||||||0.000008
71119158|NCT03392883|141743557|OTHER|Paired version (T-test for paired sample, Friedman and McNemar tests) was used for contrasting the equality among the variables at different moments of time. In order to adjust our results by potential confounders, ANCOVA analyses was performed. Symmetric 95% confidence intervals will be provided for relevant parameters. All p-values were referred to two-sided hypotheses. P-values below 0.05 were considered statistically significant.|||||<|0.001|TWO_SIDED|95.0||||p\<0.05 is the threshold for statistical significance.|t-test, 2 sided|||We analyzed changes over time for every subscale. This Statistical Analysis describes the Adoption subscale results.||||<0.001
71119159|NCT03392883|141743557|OTHER|||||||0.552||||||p\<0.05 is the threshold for statistical significance.|t-test, 2 sided|||We analyzed changes over time for every subscale in this instrument. This Statistical Analysis describes the Acceptability subscale results.||||0.552
71119160|NCT03392883|141743557|OTHER|||||||0.32||||||p\<0.05 is the threshold for statistical significance.|t-test, 2 sided|||We analyzed changes over time for every subscale in this instrument. This Statistical Analysis describes the Appropriateness subscale results.||||0.320
70943460|NCT03443063|141387400|OTHER||Percent (%) ratio of geometric means|141.07|||||TWO_SIDED|90.0|103.79|191.73|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Lemborexant||191.73|103.79|
71080542|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.17||||0.295|TWO_SIDED|95.0|-0.15|0.49|||Repeated measure model|||Baseline peripheral blood eosinophil count \>=150 cells/μL||0.49|-0.15|0.295
71080543|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.16||||0.342|TWO_SIDED|95.0|-0.17|0.49|||Repeated measure model|||Baseline peripheral blood eosinophil count \>=150 cells/μL||0.49|-0.17|0.342
71080544|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.18||||0.406|TWO_SIDED|95.0|-0.24|0.6|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 150 cells/μL||0.60|-0.24|0.406
71080545|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.38||||0.069|TWO_SIDED|95.0|-0.03|0.79|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 150 cells/μL||0.79|-0.03|0.069
71080546|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.19||||0.371|TWO_SIDED|95.0|-0.23|0.62|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 300 cells/μL||0.62|-0.23|0.371
71080547|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.07||||0.766|TWO_SIDED|95.0|-0.37|0.51|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 300 cells/μL||0.51|-0.37|0.766
71080548|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.24||||0.147|TWO_SIDED|95.0|-0.09|0.57|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 300 cells/μL||0.57|-0.09|0.147
71080549|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.35||||0.031|TWO_SIDED|95.0|0.03|0.68|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 300 cells/μL||0.68|0.03|0.031
71080550|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.59||||0.02|TWO_SIDED|95.0|0.1|1.09|||Repeated measure model|||Baseline FEV1 reversibility \>= 12%||1.09|0.10|0.020
71080551|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.29||||0.226|TWO_SIDED|95.0|-0.18|0.77|||Repeated measure model|||Baseline FEV1 reversibility \>= 12%||0.77|-0.18|0.226
71080552|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.01||||0.964|TWO_SIDED|95.0|-0.31|0.33|||Repeated measure model|||Baseline FEV1 reversibility \< 12%||0.33|-0.31|0.964
71080553|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.1||||0.533|TWO_SIDED|95.0|-0.22|0.42|||Repeated measure model|||Baseline FEV1 reversibility \< 12%||0.42|-0.22|0.533
71080554|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.17||||0.292|TWO_SIDED|95.0|-0.15|0.5|||Repeated measure model|||2 asthma exacerbations in the past year||0.50|-0.15|0.292
71080555|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.27||||0.097|TWO_SIDED|95.0|-0.05|0.59|||Repeated measure model|||2 asthma exacerbations in the past year||0.59|-0.05|0.097
71080556|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.24||||0.26|TWO_SIDED|95.0|-0.18|0.67|||Repeated measure model|||\> 2 but \< 6 asthma exacerbations in the past year||0.67|-0.18|0.260
71080557|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.1||||0.648|TWO_SIDED|95.0|-0.33|0.53|||Repeated measure model|||\> 2 but \< 6 asthma exacerbations in the past year||0.53|-0.33|0.648
71080558|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.28||||0.398|TWO_SIDED|95.0|-0.37|0.93|||Repeated measure model|||Chronic OCS use||0.93|-0.37|0.398
71080559|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.32||||0.327|TWO_SIDED|95.0|-0.95|0.32|||Repeated measure model|||Chronic OCS use||0.32|-0.95|0.327
71080560|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.23||||0.105|TWO_SIDED|95.0|-0.05|0.52|||Repeated measure model|||Without chronic OCS use||0.52|-0.05|0.105
71080561|NCT01402986|141667597|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.31||||0.03|TWO_SIDED|95.0|0.03|0.6|||Repeated measure model|||Without chronic OCS use||0.60|0.03|0.030
71080562|NCT01402986|141667598|SUPERIORITY_OR_OTHER||Rate Ratio|0.95||||0.803|TWO_SIDED|95.0|0.62|1.44|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Atopic asthma||1.44|0.62|0.803
71080563|NCT01402986|141667598|SUPERIORITY_OR_OTHER||Rate Ratio|0.83||||0.457|TWO_SIDED|95.0|0.52|1.35|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Atopic asthma||1.35|0.52|0.457
71080564|NCT01402986|141667598|SUPERIORITY_OR_OTHER||Rate Ratio|0.71||||0.25|TWO_SIDED|95.0|0.4|1.27|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Non-atopic asthma||1.27|0.40|0.250
71080565|NCT01402986|141667598|SUPERIORITY_OR_OTHER||Rate Ratio|1.07||||0.794|TWO_SIDED|95.0|0.66|1.74|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Non-atopic asthma||1.74|0.66|0.794
71080566|NCT01402986|141667599|SUPERIORITY_OR_OTHER||Rate Ratio|1.2||||0.614|TWO_SIDED|95.0|0.59|2.46|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|With chronic OCS use||2.46|0.59|0.614
71080567|NCT01402986|141667599|SUPERIORITY_OR_OTHER||Rate Ratio|1.29||||0.506|TWO_SIDED|95.0|0.61|2.74|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|With chronic OCS use||2.74|0.61|0.506
71080568|NCT01402986|141667599|SUPERIORITY_OR_OTHER||Rate Ratio|0.79||||0.243||95.0|0.53|1.18|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Without chronic OCS use||1.18|0.53|0.243
71080569|NCT01402986|141667599|SUPERIORITY_OR_OTHER||Rate Ratio|0.87||||0.531|TWO_SIDED|95.0|0.57|1.34|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Without chronic OCS use||1.34|0.57|0.531
71080570|NCT02634983|141667620|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|2.11||0.0254|TWO_SIDED|90.0|1.4|8.6|||t-test, 2 sided|||Global Ventilated Lung Volume||8.60|1.40|0.0254
71080571|NCT02634983|141667621|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|4.77|STANDARD_ERROR_OF_MEAN|2.15||0.035|TWO_SIDED|90.0|1.11|8.44|||t-test, 2 sided|||Lung, Left Ventilation||8.44|1.11|0.0350
71080572|NCT02634983|141667621|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|4.96|STANDARD_ERROR_OF_MEAN|2.86||0.0946|TWO_SIDED|90.0|0.08|9.84|||t-test, 2 sided|||Lung, Left Lower Lobe Ventilation||9.84|0.08|0.0946
70943461|NCT03443063|141387400|OTHER||Percent (%) ratio of geometric means|124.48|||||TWO_SIDED|90.0|100.58|154.06|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4||154.06|100.58|
71080573|NCT02634983|141667621|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|4.97|STANDARD_ERROR_OF_MEAN|2.41||0.0486|TWO_SIDED|90.0|0.87|9.07|||t-test, 2 sided|||Lung, Left Upper Lobe Ventilation||9.07|0.87|0.0486
71080574|NCT02634983|141667621|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|5.39|STANDARD_ERROR_OF_MEAN|2.33||0.0286|TWO_SIDED|90.0|1.42|9.35|||t-test, 2 sided|||Lung, Right Ventilation||9.35|1.42|0.0286
71080575|NCT02634983|141667621|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|3.27|STANDARD_ERROR_OF_MEAN|2.29||0.165|TWO_SIDED|90.0|-0.63|7.17|||t-test, 2 sided|||Lung, Right Lower Lobe Ventilation||7.17|-0.63|0.1650
71080576|NCT02634983|141667621|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|5.61|STANDARD_ERROR_OF_MEAN|3.71||0.1421|TWO_SIDED|90.0|-0.71|11.94|||t-test, 2 sided|||Lung, Right Middle Lobe Ventilation||11.94|-0.71|0.1421
70943462|NCT03443063|141387400|OTHER||Percent (%) ratio of geometric means|143.31|||||TWO_SIDED|90.0|107.72|190.65|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9||190.65|107.72|
71080577|NCT02634983|141667621|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|7.73|STANDARD_ERROR_OF_MEAN|2.78||0.0099|TWO_SIDED|90.0|2.98|12.47|||t-test, 2 sided|||Lung, Right Upper Lobe Ventilation||12.47|2.98|0.0099
71080578|NCT02634983|141667622|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.92||0.323|TWO_SIDED|90.0|-0.64|2.5|||t-test, 2 sided|||Lung Perfusion||2.50|-0.64|0.3230
71080579|NCT02634983|141667622|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|0.95||0.1717|TWO_SIDED|90.0|-0.29|2.97|||t-test, 2 sided|||Lung, Left Perfusion||2.97|-0.29|0.1717
71080580|NCT02634983|141667622|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|1.02||0.5031|TWO_SIDED|90.0|-1.05|2.43|||t-test, 2 sided|||Lung, Left Lower Lobe Perfusion||2.43|-1.05|0.5031
71080581|NCT02634983|141667622|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|1.03||0.076|TWO_SIDED|90.0|0.15|3.65|||t-test, 2 sided|||Lung, Left Upper Lobe Perfusion||3.65|0.15|0.0760
71080582|NCT02634983|141667622|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.93||0.5465|TWO_SIDED|90.0|-1.02|2.16|||t-test, 2 sided|||Lung, Right Perfusion||2.16|-1.02|0.5465
71080583|NCT02634983|141667622|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|1.08||0.9913|TWO_SIDED|90.0|-1.85|1.87|||t-test, 2 sided|||Lung, Right Lower Lobe Perfusion||1.87|-1.85|0.9913
71080584|NCT02634983|141667622|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|1.51|STANDARD_ERROR_OF_MEAN|1.7||0.3837|TWO_SIDED|90.0|-1.39|4.4|||t-test, 2 sided|||Lung, Right Middle Lobe Perfusion||4.40|-1.39|0.3837
71080585|NCT02634983|141667622|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.87|STANDARD_ERROR_OF_MEAN|0.94||0.3624|TWO_SIDED|90.0|-0.73|2.48|||t-test, 2 sided|||Lung, Right Upper Lobe Perfusion||2.48|-0.73|0.3624
71080586|NCT02634983|141667623|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|90.0|0.11|0.18|||t-test, 2 sided|||FEV1 Day 1 (0.25 hrs post-dose)||0.18|0.11|<0.0001
71080587|NCT02634983|141667623|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|90.0|0.15|0.25|||t-test, 2 sided|||FEV1 Day 1 (1 hrs post-dose)||0.25|0.15|<0.0001
71080588|NCT02634983|141667623|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|90.0|0.13|0.24|||t-test, 2 sided|||FEV1 Day 1 (2 hrs post-dose)||0.24|0.13|<0.0001
71080589|NCT02634983|141667623|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|90.0|0.16|0.27|||t-test, 2 sided|||FEV1 Day 8 (-0.75 hrs post-dose)||0.27|0.16|<0.0001
71080590|NCT02634983|141667623|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|90.0|0.16|0.28|||t-test, 2 sided|||FEV1 Day 8 (-0.25 hrs post-dose)||0.28|0.16|<0.0001
71080591|NCT02634983|141667623|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|90.0|0.23|0.33|||t-test, 2 sided|||FEV1 Day 8 (0.25 hrs post-dose)||0.33|0.23|<0.0001
71080592|NCT02634983|141667623|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|90.0|0.26|0.37|||t-test, 2 sided|||FEV1 Day 8 (1 hrs post-dose)||0.37|0.26|<0.0001
71080593|NCT02634983|141667623|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|90.0|0.26|0.38|||t-test, 2 sided|||FEV1 Day 8 (2 hrs post-dose)||0.38|0.26|<0.0001
71080594|NCT02634983|141667624|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|90.0|0.15|0.33|||t-test, 2 sided|||FVC Day 1 (0.25 hrs post-dose)||0.33|0.15|<0.0001
71080595|NCT02634983|141667624|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|90.0|0.25|0.45|||t-test, 2 sided|||FVC Day 1 (1 hrs post-dose)||0.45|0.25|<0.0001
71080596|NCT02634983|141667624|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|90.0|0.2|0.42|||t-test, 2 sided|||FVC Day 1 (2 hrs post-dose)||0.42|0.20|<0.0001
71119161|NCT03392883|141743557|OTHER|||||||0.879||||||p\<0.05 is the threshold for statistical significance.|t-test, 2 sided|||We analyzed changes over time for every subscale in this instrument. This Statistical Analysis describes the Feasibility subscale results.||||0.879
71119162|NCT03392883|141743557|OTHER|||||||0.242||||||p\<0.05 is the threshold for statistical significance.|t-test, 2 sided|||We analyzed changes over time for every subscale in this instrument. This Statistical Analysis describes the Reach/Access subscale results.||||0.242
71119163|NCT03392883|141743558|OTHER|||||||0.237||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Adoption subscale results.||||0.237
70854828|NCT02660138|141198071|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|110.57|||<|0.0001|TWO_SIDED|95.0|70.17|150.98|||MMRM|||Treatment group, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (total volume per void) as fixed effect variables, and subject as a random effect.||150.98|70.17|<0.0001
70854829|NCT00308581|141198074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.696||95.0|0.7|1.7||Logistic regression model including terms for treatment arm and geographical region (North America versus Europe).|Regression, Logistic||Direction of comparison is Q4W regimen (active 1) versus Q2W regimen (active 2).|With a sample size of 165 patients per treatment arm, assuming a percentage of responders of 45% with the Q4W regimen, the study had 80% power to show a statistically significant difference in percentage of responders at Week 26 between the two treatment groups, when there is a true difference of 16% in percentage of responders in favor of the Q2W regimen, and using a 2-sided chi-square at the 5% significance level.||1.7|0.7|0.696
70854830|NCT01247298|141198142|OTHER||Kaplan Meier Estimate|82.0|||||TWO_SIDED||||||||Kaplan Meier Estimates of Progression Free Survival (PFS)|||||
70854831|NCT01087788|141198144|SUPERIORITY_OR_OTHER||Difference in Percentages|33.7|||<|0.001|TWO_SIDED|95.0|22.8|44.6||Difference of Certolizumab Pegol 200 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||44.6|22.8|<0.001
70854832|NCT01087788|141198144|SUPERIORITY_OR_OTHER||Difference in Percentages|27.6|||<|0.001|TWO_SIDED|95.0|16.5|38.7||Difference of Certolizumab Pegol 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||38.7|16.5|<0.001
70854833|NCT01087788|141198145|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-10.64|STANDARD_ERROR_OF_MEAN|8.35|=|0.203|TWO_SIDED|95.0|-27.05|5.77||Diff. of CZP 200mg+400mg versus PBO (and corresponding 95% Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior Tumor Necrosis Factor(TNF)-antagonist exposure as factors \& BL mTSS score as a covariate|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected. This is the pre-defined primary analysis.||5.77|-27.05|=0.203
70872003|NCT05405309|141229403|OTHER||||||||||||||||||"The primary analysis was of safety and included all patients who received at least one dose of the investigational regimen. The rate of adverse events was estimated after the first 5 patients were treated at Original DL1 (camonsertib 40mg daily and olaparib 100mg BID dosing 2 days per week, at 28 day cycles)~After the first 5 patients were treated, it was determined that this dosing strategy may not be appropriate for R/R CLL patients and reduced dosing frequency may be necessary to increase the safety of the combination therapy. The protocol and DLs were amended, and sought to enroll an additional 18 patients.~Before the enrollment of 18 additional participants and MTD determination, the study was terminated due to sponsor de-activation of all programs associated with camonsertib."|||
71119164|NCT03392883|141743558|OTHER|||||||0.492||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Accessibility subscale results.||||0.492
71119165|NCT03392883|141743558|OTHER|||||||0.285||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Appropriateness subscale results.||||0.285
71119166|NCT03392883|141743558|OTHER|||||||0.964||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Feasibility subscale results.||||0.964
71119167|NCT03392883|141743558|OTHER|||||||0.942||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Resources subscale results.||||0.942
71119168|NCT03392883|141743558|OTHER|||||||0.366||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Scope subscale results.||||0.366
71119169|NCT03392883|141743558|OTHER|||||||0.021||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Organizational Climate subscale results.||||0.021
71119170|NCT03392883|141743558|OTHER|||||||0.832||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Leadership in Implementing subscale results.||||0.832
71119171|NCT03392883|141743558|OTHER|||||||0.827||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the General Leadership Skills subscale results.||||0.827
71119172|NCT03392883|141743559|OTHER|||||||0.118||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Adoption subscale results.||||0.118
71119173|NCT03392883|141743559|OTHER|||||||0.896||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Accessibility subscale results.||||0.896
70943463|NCT03443063|141387400|OTHER||Percent (%) ratio of geometric means|140.2|||||TWO_SIDED|90.0|98.11|200.35|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10||200.35|98.11|
71080597|NCT02634983|141667624|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|90.0|0.25|0.45|||t-test, 2 sided|||FVC Day 8 (-0.75 hrs post-dose)||0.45|0.25|<0.001
71080598|NCT02634983|141667624|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|90.0|0.19|0.37|||t-test, 2 sided|||FVC Day 8 (-0.25 hrs post-dose)||0.37|0.19|<0.0001
71119174|NCT03392883|141743559|OTHER|||||||0.739||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Appropriateness subscale results.||||0.739
71119175|NCT03392883|141743559|OTHER|||||||0.724||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Feasibility subscale results.||||0.724
71119176|NCT03392883|141743559|OTHER|||||||0.301||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Adoption subscale results.||||0.301
71119177|NCT03392883|141743559|OTHER|||||||0.034||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Organizational Climate subscale results.||||0.034
71119178|NCT03392883|141743559|OTHER|||||||0.015||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Leadership in Implementing subscale results.||||0.015
71119179|NCT03392883|141743559|OTHER|||||||0.081||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the General Leadership Skills subscale results.||||0.081
71119180|NCT03392883|141743559|OTHER|||||||0.79||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Knowledge subscale results.||||0.790
71119181|NCT03392883|141743560|OTHER|||||||0.023||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes in the overall scores over time.||||0.023
71119182|NCT03392883|141743561|OTHER|||||||0.589||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes in the overall scores over time in this data.||||0.589
71119183|NCT03392883|141743562|OTHER||Mean Difference (Net)|-6.65|||||TWO_SIDED|||||||||We analyzed changes over time by calculating the mean difference of the scores at baseline assessment and at 12-month follow-up assessment.||||
71119184|NCT03392883|141743563|OTHER||Mean Difference (Net)|-4.48|||||TWO_SIDED|||||||||We analyzed changes over time by calculating the mean difference of the total scores (sum of 12 items) at baseline assessment and at 12-month follow-up assessment.||||
70872004|NCT00279591|141229425|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Fisher Exact|||||||0.03
71119185|NCT03392883|141743564|OTHER||Mean Difference (Net)|-5.77|||||TWO_SIDED|||||||||We analyzed changes over time by calculating the mean difference of the scores at baseline assessment and at 12-month follow-up assessment.||||
71119186|NCT03392883|141743565|OTHER||Mean Difference (Net)|-2.59|||||TWO_SIDED|||||||||We analyzed changes over time by calculating the mean difference of the number of standard drinks per week at baseline assessment and at 12-month follow-up assessment.||||
71119187|NCT00132691|141743578|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.79|STANDARD_ERROR_OF_MEAN|2.03||0.16|TWO_SIDED|95.0|-1.16|6.68||unadjusted|Generalized estimating equations, linear||The treatment effect is a model-based comparison of within group treatment change from enrollment to 24 months (the difference of the differences - implant minus systemic).|"Null hypothesis: There will be no difference in change in visual acuity between treatment groups.~Assuming 67% bilateral disease, between eye correlation of 0.4, SD of 16 letters' change over 2 years and two-sided type 1 error rate of .05, a sample size of 250 provided 91% power (assuming 10% crossover) to detect a treatment difference of 7.5 standard ETDRS letters' change in visual acuity from baseline to 24 months."||6.68|-1.16|0.16
71119188|NCT00132691|141743579|SUPERIORITY_OR_OTHER||Ratio of odds ratios|0.61||||0.071|TWO_SIDED|95.0|0.34|1.03||unadjusted|GEE, logistic||For each treatment group the odds of macular edema at 2 yrs as compared to baseline was computed. The treatment effect is the ratio of these odds (implant divided by systemic).|||1.03|0.34|0.071
71119189|NCT00132691|141743580|SUPERIORITY_OR_OTHER||Ratio of odds ratios|0.29||||0.001|TWO_SIDED|95.0|0.13|0.6||unadjusted|GEE, logistic||For each treatment group the odds of uveitis activity at 2 years as compared to baseline was computed. The treatment effect represents the ratio of these odds (implant divided by systemic).|||.60|.13|0.001
71119190|NCT00132691|141743581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|6.08|||<|0.0001|TWO_SIDED|95.0|3.32|11.15||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of experiencing an IOP of 30 mmHg or greater. The systemic arm was the reference group.|||11.15|3.32|<.0001
71119191|NCT00132691|141743582|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.59|||<|0.0001|TWO_SIDED|95.0|2.34|5.5||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of experiencing an IOP of 24 mmHg or greater. The systemic arm was the reference group|||5.50|2.34|<.0001
70943464|NCT00552513|141387413|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85||||0.15|TWO_SIDED|95.0|0.68|1.06|||Regression, Logistic|||||1.06|0.68|0.15
70943465|NCT00552513|141387414|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72||||0.003|TWO_SIDED|95.0|0.58|0.89|||Regression, Logistic|||||0.89|0.58|0.003
70943466|NCT00552513|141387415|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.04|TWO_SIDED|95.0|0.71|0.99|||Regression, Logistic|||||0.99|0.71|0.04
70943467|NCT00197106|141387446|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is considered to be shown if the upper limit of the one-sided 95% confidence interval of the difference uflixotide-useretide does not exceed +15% (uflixotide-useretide represent the mean percentages of asthma symptom-free days of the two respective treatment groups).|Adjusted difference|2.6||||0.63||95.0|-8.1|13.4|||Repeated Measurements Anal. of Variance|Anal. = Analysis||||13.4|-8.1|0.63
70943468|NCT00922441|141387577|OTHER|Efficacy, Safety|||||<|0.05|||||||ANOVA|comparison between the groups||||||<0.05
70943469|NCT01040403|141387582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.016|0.092|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.092|0.016|
70943470|NCT01040403|141387582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.027|0.103|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.103|0.027|
70943471|NCT01040403|141387582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.046|0.122|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.122|0.046|
70943472|NCT01040403|141387582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|-0.027|0.049|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.049|-0.027|
70943473|NCT01040403|141387582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.008|0.069|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.069|-0.008|
70943474|NCT01040403|141387582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.019|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|-0.019|0.058|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.058|-0.019|
70943475|NCT01040403|141387582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.051|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.013|0.089|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.089|0.013|
70943476|NCT01040403|141387582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.083|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.045|0.122|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.122|0.045|
70943477|NCT01040403|141387582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.042|0.119|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.119|0.042|
70943478|NCT01040403|141387582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.006|0.071|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.071|-0.006|
70943479|NCT01040403|141387582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|-0.009|0.068|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.068|-0.009|
70943480|NCT01040403|141387582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|-0.041|0.035|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.035|-0.041|
70943481|NCT01040403|141387583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.04|0.159|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.159|0.040|
70943482|NCT01040403|141387583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.061|0.179|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.179|0.061|
70943483|NCT01040403|141387583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.041|0.16|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.160|0.041|
70943484|NCT01040403|141387583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.039|0.079|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.079|-0.039|
70943485|NCT01040403|141387583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.031|||TWO_SIDED|95.0|-0.059|0.061|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.061|-0.059|
70943486|NCT01040403|141387583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.079|0.04|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.040|-0.079|
70943487|NCT01040403|141387583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.071|0.19|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.190|0.071|
70943488|NCT01040403|141387583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.072|0.191|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.191|0.072|
70943489|NCT01040403|141387583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.067|0.187|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.187|0.067|
70943490|NCT01040403|141387583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.031|||TWO_SIDED|95.0|-0.059|0.061|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.061|-0.059|
70943491|NCT01040403|141387583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.063|0.056|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.056|-0.063|
70872005|NCT04617509|141229428|SUPERIORITY|Relative bioavailability for Formulation A (FASTED) versus Formulation B (FASTED). The calculated relative bioavailability is based on Cmax ratio (ratio of geometric means) and is presented with 90% CI.|Ratio of geometric means|1.4514|||||TWO_SIDED|90.0|1.111|1.4514||||||Relative bioavailability (A versus B)||1.4514|1.1110|
70872006|NCT04617509|141229428|SUPERIORITY|Relative bioavailability for Formulation A (FED) versus Formulation A (FASTED). The calculated relative bioavailability is based on Cmax ratio (ratio of geometric means) and is presented with 90% CI.|Ratio of geometric mean|0.5497|||||TWO_SIDED|90.0|0.3977|0.7597||||||Relative bioavailability (A FED versus A FASTED)||0.7597|0.3977|
71080599|NCT02634983|141667624|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|90.0|0.33|0.53|||t-test, 2 sided|||FVC Day 8 (0.25 hrs post-dose)||0.53|0.33|<0.0001
71080600|NCT02634983|141667624|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|90.0|0.36|0.54|||t-test, 2 sided|||FVC Day 8 (1 hrs post-dose)||0.54|0.36|<0.0001
71080601|NCT02634983|141667624|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|90.0|0.33|0.55|||t-test, 2 sided|||FVC Day 8 (2 hrs post-dose)||0.55|0.33|<0.0001
71080602|NCT02634983|141667625|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|2.17|STANDARD_ERROR_OF_MEAN|0.56||0.0006|TWO_SIDED|90.0|1.21|3.12|||t-test, 2 sided|||FEV1/FVC Day 1 (0.25 hrs post-dose)||3.12|1.21|0.0006
71080603|NCT02634983|141667625|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|2.06|STANDARD_ERROR_OF_MEAN|0.75||0.0106|TWO_SIDED|90.0|0.78|3.33|||t-test, 2 sided|||FEV1/FVC Day 1 (1 hrs post-dose)||3.33|0.78|0.0106
71119192|NCT00132691|141743583|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.28|||<|0.0001|TWO_SIDED|95.0|2.78|6.58||unadjusted|Cox proportional hazards with RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of experiencing an IOP that was 10mmHg or greater than the baseline value. The systemic arm was the reference group.|||6.58|2.78|<.0001
71119193|NCT00132691|141743584|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.19||||0.0008|TWO_SIDED|95.0|1.82|9.63||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of developing glaucoma. The systemic arm was the reference group.|||9.63|1.82|0.0008
71119194|NCT00132691|141743585|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.16|||<|0.0001|TWO_SIDED|95.0|2.67|6.47||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of using an IOP-lowering therapy. The systemic arm was the reference group.|||6.47|2.67|<.0001
71119195|NCT00132691|141743586|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|8.4|||<|0.0001|TWO_SIDED|95.0|3.39|20.82||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of having surgery to lower IOP. The systemic arm was the reference group.|||20.82|3.39|<0.0001
71119196|NCT00132691|141743587|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.12|||<|0.0001|TWO_SIDED|95.0|2.21|7.67||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of developing a cataract. The systemic arm was the reference group.|||7.67|2.21|<0.0001
71119197|NCT00132691|141743588|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.64|STANDARD_ERROR_OF_MEAN|2.3||0.043|TWO_SIDED|95.0|0.14|9.15||unadjusted|GEE, linear||The treatment effect is a model-based comparison of within group treatment change from enrollment to 24 months (the difference of the differences - implant minus systemic).|||9.15|0.14|0.043
71119198|NCT00132691|141743589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.62|STANDARD_ERROR_OF_MEAN|1.6||0.023|TWO_SIDED|95.0|0.49|6.76||unadjusted|GEE, linear||The treatment effect is a model-based comparison of within group treatment change from enrollment to 24 months (the difference of the differences - implant minus systemic)|||6.76|0.49|0.023
71119199|NCT00132691|141743590|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.95|STANDARD_ERROR_OF_MEAN|1.23||0.016|TWO_SIDED|95.0|0.54|5.36||unadjusted|Generalized Estimating Equations||The treatment effect is a model-based comparison of within group treatment change from enrollment to 24 months (the difference of the differences - implant minus systemic).|||5.36|0.54|0.016
71119200|NCT00132691|141743591|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.84|TWO_SIDED|95.0|0.39|2.15||unadjusted|Regression, Cox||A Cox proportional hazards model was used to evaluate the relative hazard of hyperlipidemia for the implant and systemic treatments. The systemic treatment is the reference group.|||2.15|0.39|0.84
71119201|NCT00132691|141743592|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||0.13|TWO_SIDED|95.0|0.13|1.29||unadjusted|Regression, Cox||A Cox proportional hazards model was used to evaluate the relative hazard of hypertension for the implant and systemic treatments. The systemic treatment is the reference group.|||1.29|0.13|0.13
71119202|NCT00132691|141743593|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26||||0.24|TWO_SIDED|95.0|0.03|2.44||unadjusted|Regression, Cox||A Cox proportional hazards model was used to evaluate the relative hazard of diabetes mellitus for the implant and systemic treatments. The systemic treatment is the reference group.|||2.44|0.03|0.24
71119203|NCT04098367|141743636|SUPERIORITY|Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.|Difference in percentage|30.6|||||TWO_SIDED|97.5|13.34|46.79|||Miettinen-Nurminen||VIVITY minus SYMFONY|||46.79|13.34|
71119204|NCT04098367|141743636|SUPERIORITY|Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.|Difference in percentage|30.1|||||TWO_SIDED|97.5|12.54|46.68|||Miettinen-Nurminen||VIVITY minus AT LARA|||46.68|12.54|
71119205|NCT04098367|141743637|SUPERIORITY|Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.|Difference in percentage|-2.3|||||TWO_SIDED|97.5|-21.91|17.42|||Miettinen-Nurminen||VIVITY minus SYMFONY|||17.42|-21.91|
71119206|NCT04098367|141743637|SUPERIORITY|Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.|Difference in percentage|8.2|||||TWO_SIDED|97.5|-12.0|27.8|||Miettinen-Nurminen||VIVITY minus AT LARA|||27.80|-12.00|
71119207|NCT04098367|141743638|SUPERIORITY|Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.|Difference in percentage|23.5|||||TWO_SIDED|97.5|4.66|40.86|||Miettinen-Nurminen||VIVITY minus SYMFONY|||40.86|4.66|
71119208|NCT04098367|141743638|SUPERIORITY|Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.|Difference in percentage|40.7|||||TWO_SIDED|97.5|21.16|57.22|||Miettinen-Nurminen||VIVITY minus AT LARA|||57.22|21.16|
71119209|NCT01106859|141743665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.0174|TWO_SIDED|95.0|0.1|1.5||No p-value adjustment for multiple comparisons.|ANOVA|The degrees of freedom are 114 for the p-value testing the difference between treatment groups.||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDLP (Zolpidem 4 Hours) - LS mean of SDLP (Placebo).||1.5|0.1|0.0174
71119210|NCT01106859|141743665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|||<|0.0001|TWO_SIDED|95.0|0.8|2.1||No p-value adjustment for multiple comparisons.|ANOVA|The degrees of freedom are 114 for the p-value testing the difference between treatment groups||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDLP (Zolpidem 3 Hours) - LS mean of SDLP (Placebo).||2.1|0.8|<0.0001
71119211|NCT01106859|141743665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||<|0.0001|TWO_SIDED|95.0|1.8|3.1||No p-value adjustment for multiple comparisons|ANOVA|The degrees of freedom are 114 for the p-value testing the difference between treatment groups||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDLP (Zopiclone) - LS mean of SDLP (Placebo).||3.1|1.8|<0.0001
70943492|NCT01040403|141387583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.064|0.055|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.055|-0.064|
71119212|NCT01106859|141743666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.0145|TWO_SIDED|95.0|0.03|0.27||No p-value adjustment for multiple comparisons|ANOVA|The degrees of freedom are 113 for the p-value testing the difference between treatment groups||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDS (Zolpidem 4 hours prior) - LS mean of SDS (Placebo).||0.27|0.03|0.0145
70943493|NCT01040403|141387584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.035|0.114|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-3h||0.114|0.035|
71119213|NCT01106859|141743666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.2179|TWO_SIDED|95.0|-0.05|0.2||No p-value adjustment for multiple comparisons|ANOVA|The degrees of freedom are 113 for the p-value testing the difference between treatment groups||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDS (Zolpidem 3 Hours) - LS mean of SDS (Placebo).||0.20|-0.05|0.2179
71119214|NCT01106859|141743666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.0096|TWO_SIDED|95.0|0.04|0.29||No p-value adjustment for multiple comparisons|ANOVA|The degrees of freedom are 113 for the p-value testing the difference between treatment groups||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDS (Zopiclone) - LS mean of SDS (Placebo).||0.29|0.04|0.0096
71119215|NCT01106859|141743669|SUPERIORITY_OR_OTHER|||||||0.2188||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 4 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.2188
71119216|NCT01106859|141743669|SUPERIORITY_OR_OTHER|||||||0.0117||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 3 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.0117
71119217|NCT01106859|141743669|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zopiclone 9 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||<0.0001
71119218|NCT01106859|141743671|SUPERIORITY_OR_OTHER|||||||0.125||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.0 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 4 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.1250
71119219|NCT01106859|141743671|SUPERIORITY_OR_OTHER|||||||0.0074||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.0 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 3 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.0074
71119220|NCT01106859|141743671|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.0 cm in Standard Deviation of Lateral Position (SDLP) following administration of Zopiclone 9 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||<0.0001
71119221|NCT01106859|141743673|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-3.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 4 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.5000
71119222|NCT01106859|141743673|SUPERIORITY_OR_OTHER|||||||0.0156||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-3.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 3 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.0156
70943494|NCT01040403|141387584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.057|0.137|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-3h||0.137|0.057|
70943495|NCT01040403|141387584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.079|0.159|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-3h||0.159|0.079|
70943496|NCT01040403|141387584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.017|0.062|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-3h||0.062|-0.017|
70943497|NCT01040403|141387584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.021|||TWO_SIDED|95.0|0.004|0.085|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-3h||0.085|0.004|
70943498|NCT01040403|141387584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.018|0.062|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-3h||0.062|-0.018|
70943499|NCT01040403|141387584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.057|0.137|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-3h||0.137|0.057|
71119223|NCT01106859|141743673|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-3.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zopiclone 9 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.0001
70943500|NCT01040403|141387584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.088|0.168|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-3h||0.168|0.088|
70943501|NCT01040403|141387584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.103|0.183|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-3h||0.183|0.103|
70943502|NCT01040403|141387584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.009|0.071|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-3h||0.071|-0.009|
70943503|NCT01040403|141387584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.006|0.086|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-3h||0.086|0.006|
70943504|NCT01040403|141387584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.015|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.025|0.055|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-3h||0.055|-0.025|
70943505|NCT01040403|141387584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.04|0.117|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-6h||0.117|0.040|
70943506|NCT01040403|141387584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.06|0.137|||Mixed Models Analysis||difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-6h||0.137|0.060|
70943507|NCT01040403|141387584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.08|0.157|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-6h||0.157|0.080|
70943508|NCT01040403|141387584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|-0.018|0.058|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-6h||0.058|-0.018|
71119224|NCT03777709|141743679|SUPERIORITY||Mean Difference (Final Values)|1.45|STANDARD_DEVIATION|2.0|<|0.0001|TWO_SIDED|||||unadjusted p-value|Regression, Linear||A recruitment aim of 40 participants per church (16 churches, 8 per arm, mean of 5 participants per church) provides 80% power to detect a difference of 1.45 in mean LS7 score change between groups (effect size 0.73).|Effect size of 1-unit difference in mean LS7 score was based on meta-analysis indicating each unit increase in mean LS7 metrics equates to a 19% and 11% reduction in CVD and all-cause mortality, respectively. Power calculations to estimate sample size: church goal of 16 churches (8/arm), with mean 5 participants/church (40/arm) to provide 80% power to detect 1.45 difference in average LS7 score change between groups (.01 intracluster correlation, and .5 coefficient of variation of church sizes).||||<0.0001
71119225|NCT03575065|141743706|SUPERIORITY|||||||0.021||||||p-value was based on an exact binomial test with historic control ORR=0.25|Exact Binomial Test|||||||0.0210
71119226|NCT01528891|141743756|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, and PACU.~P-values are adjusted for multiple comparisons."|t-test, 2 sided|||Heart rate values at each time point were compared between groups.||||<0.01
71119227|NCT01528891|141743756|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, as compared to the baseline value: 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, and PACU.~P-values are adjusted for multiple comparisons."|ANOVA|||Heart rate values were compared over time against the baseline value.||||<0.01
71119228|NCT01528891|141743756|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, as compared to the baseline value: 4 minutes, 5 minutes, and PACU.~P-values are adjusted for multiple comparisons."|ANOVA|||Heart rate values were compared over time against the baseline value.||||<0.01
71119229|NCT01528891|141743757|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P\<0.0001 was calculated for both groups.|Fisher Exact|||The incidence of agitated patients in each group was compared.||||<0.0001
71119230|NCT01528891|141743758|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points: 1 minute, 4 minutes, 5 minutes, and PACU.~P-values are adjusted for multiple comparisons."|t-test, 2 sided|||Systolic blood pressure values were compared between groups at each time point.||||<0.01
71119231|NCT01528891|141743758|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, as compared to the baseline value: 1 minute, 3 minutes, 4 minutes, and 5 minutes.~P-values are adjusted for multiple comparisons."|ANOVA|||SBP values were compared against the baseline value within each group over time.||||<0.01
71119232|NCT01528891|141743758|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, as compared to the baseline value: 5 minutes and PACU.~P-values were adjusted for multiple comparisons."|ANOVA|||SBP values were compared against the baseline within each group over time.||||<0.01
71119233|NCT01528891|141743759|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points: 1 minute and PACU.~P-values were adjusted for multiple comparisons."|t-test, 2 sided|||DBP values were compared between groups at each time point.||||<0.01
71119234|NCT01528891|141743759|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, as compared to baseline: 1 minute, 3 minutes, 4 minutes, 5 minutes, PACU.~P-values were adjusted for multiple comparisons."|ANOVA|||DBP values were compared within each group against the baseline value.||||<0.01
71119235|NCT01528891|141743759|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, as compared to baseline: 4 minutes, 5 minutes, PACU.~P-values were adjusted for multiple comparisons."|ANOVA|||DBP values were compared against the baseline value within each group over time.||||<0.01
71119236|NCT03172884|141743797|OTHER||LS means|1.385|||||TWO_SIDED|90.0|0.921|2.081||||||Moderate Hepatic Impairment vs Healthy Subjects||2.081|0.921|
71119237|NCT03172884|141743797|OTHER||LS means|1.445|||||TWO_SIDED|90.0|0.998|2.093||||||Severe hepatic impairment group vs Healthy Subjects||2.093|0.998|
71119238|NCT03172884|141743797|OTHER||LS means|0.646|||||TWO_SIDED|90.0|0.486|0.858||||||Severe renal impairment group vs Healthy Subjects||0.858|0.486|
71119239|NCT03172884|141743798|OTHER||LS Means|1.711|||||TWO_SIDED|90.0|1.148|2.55||||||Moderate Hepatic Impairment group vs Healthy Subjects||2.550|1.148|
71119240|NCT03172884|141743798|OTHER||LS Means|2.705|||||TWO_SIDED|90.0|2.115|3.46||||||Severe hepatic impairment group vs Healthy Subjects||3.460|2.115|
71119241|NCT03172884|141743798|OTHER||LS Means|1.075|||||TWO_SIDED|90.0|0.696|1.659||||||Severe renal impairment group vs Healthy Subjects||1.659|0.696|
71119242|NCT03172884|141743799|OTHER||LS Means|1.768|||||TWO_SIDED|90.0|1.251|2.498||||||Moderate Hepatic Impairment group vs Healthy Subjects||2.498|1.251|
71119243|NCT03172884|141743799|OTHER||LS Means|2.735|||||TWO_SIDED|90.0|2.163|3.459||||||Severe hepatic impairment group vs Healthy Subjects||3.459|2.163|
71119244|NCT03172884|141743799|OTHER||LS Means|1.124|||||TWO_SIDED|90.0|0.815|1.549||||||Severe renal impairment group vs Healthy Subjects||1.549|0.815|
71119245|NCT00957944|141743822|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|1.0302||||||90.0|0.9693|1.0951|||ANOVA|ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||1.0951|0.9693|
71119246|NCT00957944|141743823|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|1.0571||||||90.0|0.9903|1.1284|||ANOVA|ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||1.1284|0.9903|
70872007|NCT04617509|141229429|SUPERIORITY|Relative bioavailability for Formulation A (FASTED) versus Formulation B (FASTED). The calculated relative bioavailability is based on AUC0-inf ratio (ratio of geometric means) and is presented with 90% CI.|Ratio of geometric mean|1.3441|||||TWO_SIDED|90.0|1.0953|1.6495||||||Relative bioavailability (A versus B)||1.6495|1.0953|
70943509|NCT01040403|141387584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.001|0.079|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-6h||0.079|0.001|
70943510|NCT01040403|141387584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.019|0.058|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-6h||0.058|-0.019|
70943511|NCT01040403|141387584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.06|0.136|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-6h||0.136|0.060|
70943512|NCT01040403|141387584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.083|0.159|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-6h||0.159|0.083|
70943513|NCT01040403|141387584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.105|0.182|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-6h||0.182|0.105|
70943514|NCT01040403|141387584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.016|0.062|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-6h||0.062|-0.016|
70943515|NCT01040403|141387584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.007|0.084|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-6h||0.084|0.007|
70943516|NCT01040403|141387584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.016|0.061|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-6h||0.061|-0.016|
70943517|NCT01040403|141387585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.058|0.012|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.012|-0.058|
70943518|NCT01040403|141387585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.029|0.04|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.040|-0.029|
70943519|NCT01040403|141387585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.034|0.036|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.036|-0.034|
70943520|NCT01040403|141387585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.006|0.063|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.063|-0.006|
70943521|NCT01040403|141387585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.011|0.059|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.059|-0.011|
70943522|NCT01040403|141387585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.039|0.031|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.031|-0.039|
70943523|NCT01040403|141387585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|0.004|0.073|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.073|0.004|
70943524|NCT01040403|141387585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.004|0.066|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.066|-0.004|
70943525|NCT01040403|141387585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.041|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|0.006|0.076|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.076|0.006|
70943526|NCT01040403|141387585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.043|0.027|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.027|-0.043|
70943527|NCT01040403|141387585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.032|0.037|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.037|-0.032|
70943528|NCT01040403|141387585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.025|0.045|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.045|-0.025|
70943529|NCT01040403|141387586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|0.041|0.138|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.138|0.041|
70943530|NCT01040403|141387586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.024|||TWO_SIDED|95.0|0.043|0.139|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.139|0.043|
70943531|NCT01040403|141387586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|0.066|0.164|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.164|0.066|
70943532|NCT01040403|141387586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|-0.046|0.05|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.050|-0.046|
70943533|NCT01040403|141387586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|-0.023|0.074|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.074|-0.023|
70943534|NCT01040403|141387586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|-0.025|0.072|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.072|-0.025|
70943535|NCT01040403|141387586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|0.059|0.156|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.156|0.059|
71119247|NCT00957944|141743824|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|1.0289||||||90.0|0.9714|1.0899|||ANOVA|ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||1.0899|0.9714|
71119248|NCT00522418|141743837|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||F Test|||||||.01
71119249|NCT00522418|141743840|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||F-Test|||||||0.17
71119250|NCT00522418|141743843|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||F-Test|||||||0.17
71119251|NCT00522418|141743844|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||F-Test|||||||0.28
71119252|NCT00522418|141743845|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||F-Test|||||||0.03
71119253|NCT00522418|141743846|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||F-Test|||||||0.26
71119254|NCT01939002|141743868|SUPERIORITY_OR_OTHER||||||<|0.0001||||||1-sample Chi-square test comparing to Null hypotheses at 25%.|Chi-squared|||||||<0.0001
71119255|NCT01939002|141743869|SUPERIORITY_OR_OTHER|||||||0.2037||||||Chi-square test between 2 treatment arms.|Chi-squared|||||||0.2037
71119256|NCT01939002|141743871|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|McNemar tests the null hypothesis of no difference in FLS between 4WRI and F8W.||||||1.00
71119257|NCT01939002|141743871|SUPERIORITY_OR_OTHER|||||||0.5078|||||||McNemar|||||||0.5078
71119258|NCT01939002|141743871|SUPERIORITY_OR_OTHER|||||||0.5811|||||||McNemar|||||||0.5811
71119259|NCT01939002|141743872|SUPERIORITY_OR_OTHER|||||||0.0525|||||||McNemar|||||||0.0525
71119260|NCT01939002|141743872|SUPERIORITY_OR_OTHER|||||||0.0654|||||||McNemar|||||||0.0654
71119261|NCT01939002|141743872|SUPERIORITY_OR_OTHER|||||||0.5488|||||||McNemar|||||||0.5488
71119262|NCT01939002|141743873|SUPERIORITY_OR_OTHER|||||||0.0945|||||||paired t-test within 1 arm|||||||0.0945
71119263|NCT01939002|141743873|SUPERIORITY_OR_OTHER|||||||0.8246|||||||paired t-test within 1 arm|||||||0.8246
71119264|NCT01939002|141743873|SUPERIORITY_OR_OTHER|||||||0.2533|||||||paired t-test within 1 arm|||||||0.2533
71119265|NCT01939002|141743873|SUPERIORITY_OR_OTHER|||||||0.1631|||||||2-sample t-test between 2 arms|||||||0.1631
71119266|NCT01939002|141743874|SUPERIORITY_OR_OTHER|||||||0.3189|||||||paired t-test within 1 arm|||||||0.3189
71119267|NCT01939002|141743874|SUPERIORITY_OR_OTHER|||||||0.3582|||||||paired t-test within 1 arm|||||||0.3582
71119268|NCT01939002|141743874|SUPERIORITY_OR_OTHER|||||||0.8484|||||||paired t-test within 1 arm|||||||0.8484
71119269|NCT01939002|141743874|SUPERIORITY_OR_OTHER|||||||0.1771|||||||2-sample t-test between 2 arms|||||||0.1771
71119270|NCT01939002|141743875|SUPERIORITY_OR_OTHER|||||||0.0009|||||||paired t-test within 1 arm|||||||0.0009
71119271|NCT01939002|141743875|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||||||<0.0001
71119272|NCT01939002|141743875|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||||||<0.0001
71119273|NCT01939002|141743875|SUPERIORITY_OR_OTHER|||||||0.3792|||||||2-sample t-test between 2 arms|||||||0.3792
71119274|NCT01939002|141743876|SUPERIORITY_OR_OTHER|||||||0.0019|||||||paired t-test within 1 arm|||||||0.0019
71119275|NCT01939002|141743876|SUPERIORITY_OR_OTHER|||||||0.0009|||||||paired t-test within 1 arm|||||||0.0009
71119276|NCT01939002|141743876|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||||||<0.0001
71119277|NCT01939002|141743877|SUPERIORITY_OR_OTHER|||||||0.0105|||||||paired t-test within 1 arm|||||||0.0105
71119278|NCT01939002|141743877|SUPERIORITY_OR_OTHER|||||||0.0789|||||||paired t-test within 1 arm|||||||0.0789
71119279|NCT01939002|141743877|SUPERIORITY_OR_OTHER|||||||0.0027|||||||paired t-test within 1 arm|||||||0.0027
71119280|NCT01939002|141743877|SUPERIORITY_OR_OTHER|||||||0.838|||||||2-sample t-test between 2 arms|||||||0.8380
71119281|NCT01939002|141743878|SUPERIORITY_OR_OTHER|||||||0.1407|||||||paired t-test within 1 arm|||||||0.1407
71119282|NCT01939002|141743878|SUPERIORITY_OR_OTHER|||||||0.7805|||||||paired t-test within 1 arm|||||||0.7805
71119283|NCT01939002|141743878|SUPERIORITY_OR_OTHER|||||||0.2186|||||||paired t-test within 1 arm|||||||0.2186
71119284|NCT01939002|141743878|SUPERIORITY_OR_OTHER|||||||0.4234|||||||2-sample t-test between 2 arms|||||||0.4234
71119285|NCT01939002|141743879|SUPERIORITY_OR_OTHER|||||||0.009|||||||paired t-test within 1 arm|||||||0.0090
71119286|NCT01939002|141743879|SUPERIORITY_OR_OTHER|||||||0.0075|||||||paired t-test within 1 arm|||||||0.0075
71119287|NCT01939002|141743879|SUPERIORITY_OR_OTHER|||||||0.0002|||||||paired t-test within 1 arm|||||||0.0002
71119288|NCT01939002|141743879|SUPERIORITY_OR_OTHER|||||||0.7497|||||||2-sample t-test between 2 arms|||||||0.7497
71119289|NCT01939002|141743880|SUPERIORITY_OR_OTHER|||||||0.0545|||||||paired t-test within 1 arm|||||||0.0545
71119290|NCT01939002|141743880|SUPERIORITY_OR_OTHER|||||||0.3377|||||||paired t-test within 1 arm|||||||0.3377
71119291|NCT01939002|141743880|SUPERIORITY_OR_OTHER|||||||0.0391|||||||paired t-test within 1 arm|||||||0.0391
71119292|NCT01939002|141743880|SUPERIORITY_OR_OTHER|||||||0.4861|||||||2-sample t-test between 2 arms|||||||0.4861
71119293|NCT01939002|141743881|SUPERIORITY_OR_OTHER|||||||0.0834|||||||Fisher Exact|||first 8 weeks||||0.0834
71119294|NCT01939002|141743881|SUPERIORITY_OR_OTHER|||||||0.0767|||||||Fisher Exact|||Weeks 0-2||||0.0767
71119295|NCT01939002|141743881|SUPERIORITY_OR_OTHER|||||||0.732|||||||Fisher Exact|||Weeks 3-4||||0.7320
71119296|NCT01939002|141743881|SUPERIORITY_OR_OTHER|||||||0.5008|||||||Fisher Exact|||Weeks 5-6||||0.5008
71119297|NCT01939002|141743881|SUPERIORITY_OR_OTHER|||||||0.6422|||||||Fisher Exact|||Weeks 7-8||||0.6422
71119298|NCT01939002|141743882|SUPERIORITY_OR_OTHER|||||||0.2123|||||||paired t-test within 1 arm|||change at Week 4||||0.2123
71119299|NCT01939002|141743882|SUPERIORITY_OR_OTHER|||||||0.5834|||||||paired t-test within 1 arm|||change at Week 12||||0.5834
71119300|NCT01939002|141743882|SUPERIORITY_OR_OTHER|||||||0.8723|||||||paired t-test within 1 arm|||change at Week 24||||0.8723
71119301|NCT01939002|141743882|SUPERIORITY_OR_OTHER|||||||0.4173|||||||paired t-test within 1 arm|||change at Week 36||||0.4173
71080604|NCT02634983|141667625|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|2.32|STANDARD_ERROR_OF_MEAN|0.66||0.0013|TWO_SIDED|90.0|1.2|3.44|||t-test, 2 sided|||FEV1/FVC Day 1 (2 hrs post-dose)||3.44|1.20|0.0013
71080605|NCT02634983|141667625|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|2.82|STANDARD_ERROR_OF_MEAN|0.83||0.0017|TWO_SIDED|90.0|1.41|4.23|||t-test, 2 sided|||FEV1/FVC Day 8 (-0.75 hrs post-dose)||4.23|1.41|0.0017
71080606|NCT02634983|141667625|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|3.8|STANDARD_ERROR_OF_MEAN|0.76|<|0.0001|TWO_SIDED|90.0|2.51|5.09|||t-test, 2 sided|||FEV1/FVC Day 8 (-0.25 hrs post-dose)||5.09|2.51|<0.0001
71119302|NCT01939002|141743882|SUPERIORITY_OR_OTHER|||||||0.2267|||||||paired t-test within 1 arm|||change at Week 48||||0.2267
71119303|NCT01939002|141743882|SUPERIORITY_OR_OTHER|||||||0.0171|||||||paired t-test within 1 arm|||change at Early Term||||0.0171
71119304|NCT01939002|141743883|SUPERIORITY_OR_OTHER|||||||0.0001|||||||paired t-test within 1 arm|||change at Week 4||||0.0001
71119305|NCT01939002|141743883|SUPERIORITY_OR_OTHER|||||||0.0007|||||||paired t-test within 1 arm|||change at Week 12||||0.0007
71119306|NCT01939002|141743883|SUPERIORITY_OR_OTHER|||||||0.0365|||||||paired t-test within 1 arm|||change at Week 24||||0.0365
71119307|NCT01939002|141743883|SUPERIORITY_OR_OTHER|||||||0.0197|||||||paired t-test within 1 arm|||change at Week 36||||0.0197
71119308|NCT01939002|141743883|SUPERIORITY_OR_OTHER|||||||0.4031|||||||paired t-test within 1 arm|||change at Week 48||||0.4031
71119309|NCT01939002|141743883|SUPERIORITY_OR_OTHER|||||||0.006|||||||paired t-test within 1 arm|||change at Early Termination||||0.0060
71119310|NCT01939002|141743884|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 4||||<0.0001
71119311|NCT01939002|141743884|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 12||||<0.0001
71119312|NCT01939002|141743884|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 24||||<0.0001
71119313|NCT01939002|141743884|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 36||||<0.0001
71119314|NCT01939002|141743884|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 48||||<0.0001
71119315|NCT01939002|141743884|SUPERIORITY_OR_OTHER|||||||0.1789|||||||paired t-test within 1 arm|||change at Early Termination||||0.1789
71119316|NCT01939002|141743884|SUPERIORITY_OR_OTHER|||||||0.2248||||||p-value on slope is based on general linear model with repeat measures over all visits.|general linear model|||||||0.2248
71119317|NCT01939002|141743885|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 4||||<0.0001
71119318|NCT01939002|141743885|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 12||||<0.0001
70943536|NCT01040403|141387586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|0.084|0.181|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.181|0.084|
71080607|NCT02634983|141667625|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|3.74|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED|90.0|2.45|5.02|||t-test, 2 sided|||FEV1/FVC Day 8 (0.25 hrs post-dose)||5.02|2.45|<0.0001
71119319|NCT01939002|141743885|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 24||||<0.0001
71119320|NCT01939002|141743885|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 36||||<0.0001
71119321|NCT01939002|141743885|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 48||||<0.0001
71119322|NCT01939002|141743885|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Early Termination||||<0.0001
71119323|NCT01939002|141743885|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value on slope is based on general linear model with repeat measures over all visits.|general linear model|||||||<0.0001
71119324|NCT01939002|141743886|SUPERIORITY_OR_OTHER|||||||0.7012|||||||paired t-test within 1 arm|||change at Week 4||||0.7012
71119325|NCT01939002|141743886|SUPERIORITY_OR_OTHER|||||||0.0548|||||||paired t-test within 1 arm|||change at Week 4||||0.0548
71119326|NCT01939002|141743886|SUPERIORITY_OR_OTHER|||||||0.0782|||||||2-sample t-test between 2 arms|||change at Week 4||||0.0782
71119327|NCT01939002|141743887|SUPERIORITY_OR_OTHER|||||||0.0006|||||||paired t-test within 1 arm|||change at Week 4||||0.0006
71119328|NCT01939002|141743887|SUPERIORITY_OR_OTHER|||||||0.0792|||||||paired t-test within 1 arm|||change at Week 4||||0.0792
71119329|NCT01939002|141743887|SUPERIORITY_OR_OTHER|||||||0.0961|||||||2-sample t-test between 2 arms|||change at Week 4||||0.0961
71119330|NCT01939002|141743888|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 4||||<0.0001
71119331|NCT01939002|141743888|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 4||||<0.0001
71119332|NCT01939002|141743888|SUPERIORITY_OR_OTHER|||||||0.4973|||||||2-sample t-test between 2 arms|||change at Week 4||||0.4973
71119333|NCT01939002|141743889|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 4||||<0.0001
71119334|NCT01939002|141743889|SUPERIORITY_OR_OTHER|||||||0.0464|||||||paired t-test within 1 arm|||change at Week 4||||0.0464
70943537|NCT01040403|141387586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|0.096|0.193|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.193|0.096|
70943538|NCT01040403|141387586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.025|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|-0.024|0.074|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.074|-0.024|
70943539|NCT01040403|141387586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|-0.01|0.086|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.086|-0.010|
70943540|NCT01040403|141387586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.013|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|-0.036|0.061|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.061|-0.036|
70943541|NCT01040403|141387587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.059|0.02|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.020|-0.059|
70943542|NCT01040403|141387587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.026|0.053|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.053|-0.026|
70943543|NCT01040403|141387587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.028|0.051|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.051|-0.028|
70943544|NCT01040403|141387587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.006|0.072|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.072|-0.006|
70943545|NCT01040403|141387587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.009|0.071|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.071|-0.009|
70943546|NCT01040403|141387587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.041|0.037|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.037|-0.041|
70943547|NCT01040403|141387587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.015|0.093|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.093|0.015|
70943548|NCT01040403|141387587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.006|0.084|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.084|0.006|
71080608|NCT02634983|141667625|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|4.6|STANDARD_ERROR_OF_MEAN|0.85|<|0.0001|TWO_SIDED|90.0|3.16|6.03|||t-test, 2 sided|||FEV1/FVC Day 8 (1 hrs post-dose)||6.03|3.16|<0.0001
71119335|NCT01939002|141743889|SUPERIORITY_OR_OTHER|||||||0.1905|||||||2-sample t-test between 2 arms|||change at Week 4||||0.1905
70943549|NCT01040403|141387587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.008|0.087|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.087|0.008|
70943550|NCT01040403|141387587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.009|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.049|0.031|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.031|-0.049|
70943551|NCT01040403|141387587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.046|0.033|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.033|-0.046|
70943552|NCT01040403|141387587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.037|0.042|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.042|-0.037|
70943553|NCT01040403|141387588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.084|0.202|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-3h||0.202|0.084|
70943554|NCT01040403|141387588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.092|0.21|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-3h||0.210|0.092|
70943555|NCT01040403|141387588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.072|0.191|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-3h||0.191|0.072|
70943556|NCT01040403|141387588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.051|0.066|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-3h||0.066|-0.051|
70943557|NCT01040403|141387588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.071|0.048|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-3h||0.048|-0.071|
70943558|NCT01040403|141387588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.079|0.039|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-3h||0.039|-0.079|
70943559|NCT01040403|141387588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.116|0.234|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-3h||0.234|0.116|
70943560|NCT01040403|141387588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.116|0.234|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-3h||0.234|0.116|
70943561|NCT01040403|141387588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.14|0.259|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-3h||0.259|0.140|
71119336|NCT01939002|141743890|SUPERIORITY_OR_OTHER|||||||0.6569|||||||paired t-test within 1 arm|||change at Week 12||||0.6569
71119337|NCT01939002|141743890|SUPERIORITY_OR_OTHER|||||||0.1584|||||||paired t-test within 1 arm|||change at Week 24||||0.1584
71119338|NCT01939002|141743890|SUPERIORITY_OR_OTHER|||||||0.5106|||||||paired t-test within 1 arm|||change at Week 36||||0.5106
71119339|NCT01939002|141743890|SUPERIORITY_OR_OTHER|||||||0.5927|||||||paired t-test within 1 arm|||change at Week 48||||0.5927
71119340|NCT01939002|141743890|SUPERIORITY_OR_OTHER|||||||0.384|||||||paired t-test within 1 arm|||change at Early Termination||||0.3840
71119341|NCT01939002|141743890|SUPERIORITY_OR_OTHER|||||||0.4182||||||p-value on slope is based on general linear model with repeat measures over all visits.|general linear model|||||||0.4182
71080609|NCT02634983|141667625|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|4.98|STANDARD_ERROR_OF_MEAN|0.83|<|0.0001|TWO_SIDED|90.0|3.56|6.39|||t-test, 2 sided|||FEV1/FVC Day 8 (2 hrs post-dose)||6.39|3.56|<0.0001
71080610|NCT02634983|141667626|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.36||0.982|TWO_SIDED|90.0|-0.62|0.6|||t-test, 2 sided|||Lung Clearance Index||0.60|-0.62|0.9820
71080611|NCT02634983|141667627|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.36||0.0821|TWO_SIDED|90.0|0.04|1.27|||t-test, 2 sided|||Diffusion Capacity of Lung for CO||1.27|0.04|0.0821
71080612|NCT03749109|141667646|OTHER||Difference in LS mean|1.74||||0.78|TWO_SIDED|95.0|-10.45|13.94|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma||13.94|-10.45|0.78
71119342|NCT01939002|141743891|SUPERIORITY_OR_OTHER|||||||0.2588|||||||paired t-test within 1 arm|||change at Week 12||||0.2588
71119343|NCT01939002|141743891|SUPERIORITY_OR_OTHER|||||||0.1092|||||||paired t-test within 1 arm|||change at Week 24||||0.1092
71119344|NCT01939002|141743891|SUPERIORITY_OR_OTHER|||||||1|||||||paired t-test within 1 arm|||change at Week 36||||1.0000
71119345|NCT01939002|141743891|SUPERIORITY_OR_OTHER|||||||0.219|||||||paired t-test within 1 arm|||change at Week 48||||0.2190
71119346|NCT01939002|141743891|SUPERIORITY_OR_OTHER|||||||0.6402||||||p-value on slope is based on general linear model with repeat measures over all visits.|general linear model|||||||0.6402
71119347|NCT01939002|141743892|SUPERIORITY_OR_OTHER|||||||0.4821|||||||paired t-test within 1 arm|||change at Week 12||||0.4821
71119348|NCT01939002|141743892|SUPERIORITY_OR_OTHER|||||||0.5298|||||||paired t-test within 1 arm|||change at Week 24||||0.5298
71119349|NCT01939002|141743892|SUPERIORITY_OR_OTHER|||||||0.1584|||||||paired t-test within 1 arm|||change at Week 36||||0.1584
71119350|NCT01939002|141743892|SUPERIORITY_OR_OTHER|||||||0.2547|||||||paired t-test within 1 arm|||change at Week 48||||0.2547
71119351|NCT01939002|141743892|SUPERIORITY_OR_OTHER|||||||0.0824|||||||paired t-test within 1 arm|||change at Early Termination||||0.0824
71119352|NCT01939002|141743892|SUPERIORITY_OR_OTHER|||||||0.3148||||||p-value on slope is based GLM with repeat measures over all visits.|general linear model|||||||0.3148
71119353|NCT01939002|141743893|SUPERIORITY_OR_OTHER|||||||0.6508|||||||paired t-test within 1 arm|||change at Week 12||||0.6508
71119354|NCT01939002|141743893|SUPERIORITY_OR_OTHER|||||||0.0315|||||||paired t-test within 1 arm|||change at Week 48||||0.0315
71119355|NCT01939002|141743893|SUPERIORITY_OR_OTHER|||||||0.119|||||||paired t-test within 1 arm|||change at Early Termination||||0.1190
71119356|NCT01939002|141743893|SUPERIORITY_OR_OTHER|||||||0.152||||||p-value on slope is based GLM with repeat measures over all visits.|general linear model|||||||0.1520
71119357|NCT01939002|141743895|SUPERIORITY_OR_OTHER|||||||0.0049|||||||paired t-test within 1 arm|||Change from 4WRI to L4W||||0.0049
71119358|NCT01939002|141743895|SUPERIORITY_OR_OTHER|||||||0.223|||||||paired t-test within 1 arm|||Change from 4WRI to L4W||||0.2230
71119359|NCT01939002|141743895|SUPERIORITY_OR_OTHER|||||||0.0031|||||||paired t-test within 1 arm|||Change from 4WRI to L4W||||0.0031
71080613|NCT03749109|141667646|OTHER||Difference in LS mean|3.35||||0.29|TWO_SIDED|95.0|-2.89|9.59|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE||9.59|-2.89|0.29
71080614|NCT03749109|141667646|OTHER||Difference in LS mean|0.33||||0.95|TWO_SIDED|95.0|-10.33|10.99|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis||10.99|-10.33|0.95
71080615|NCT03749109|141667647|OTHER||Difference in LS mean|-6.99||||0.65|TWO_SIDED|95.0|-36.8|22.82|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma||22.82|-36.80|0.65
71080616|NCT03749109|141667647|OTHER||Difference in LS mean|-1.13||||0.92|TWO_SIDED|95.0|-22.77|20.51|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE||20.51|-22.77|0.92
71080617|NCT03749109|141667647|OTHER||Difference in LS mean|-5.92||||0.74|TWO_SIDED|95.0|-40.94|29.1|||ANCOVA|ANCOVA adjusted for baseline lesion size.||||29.10|-40.94|0.74
71080618|NCT03749109|141667648|OTHER||Odds Ratio (OR)|1.04||||0.95|TWO_SIDED|95.0|0.38|2.82|||Regression, Logistic|||Endometrioma||2.82|0.38|0.95
71080619|NCT03749109|141667648|OTHER||Odds Ratio (OR)|0.55||||0.39|TWO_SIDED|95.0|0.14|2.17|||Regression, Logistic|||Adenomyosis||2.17|0.14|0.39
71080620|NCT03749109|141667649|OTHER||Odds Ratio (OR)|0.7||||0.6|TWO_SIDED|95.0|0.19|2.65|||Regression, Logistic|||Endometrioma||2.65|0.19|0.60
71080621|NCT03749109|141667649|OTHER||Odds Ratio (OR)|0.35||||0.21|TWO_SIDED|95.0|0.07|1.79|||Regression, Logistic|||Adenomyosis||1.79|0.07|0.21
71119360|NCT01939002|141743895|SUPERIORITY_OR_OTHER|||||||0.1624|||||||2-sample t-test between 2 arms|||Change from 4WRI to L4W||||0.1624
71119361|NCT00433160|141743942|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Last Measurement Point. No adjustments for multiplicity was performed.|t-test, 2 sided|||Null hypothesis: there is no difference in the percent change in bone mineral density at lumbar spine (L2-L4) after 52-week treatment between the two treatment groups.||||<0.001
71119362|NCT00433160|141743946|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 4. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in PINP after 4-week treatment between the two treatment groups.||||<0.001
71119363|NCT00433160|141743946|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 12. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in PINP after 12-week treatment between the two treatment groups.||||<0.001
71119364|NCT00433160|141743946|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 24. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in PINP after 24-week treatment between the two treatment groups.||||<0.001
71119365|NCT00433160|141743946|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 52. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in PINP after 52-week treatment between the two treatment groups.||||<0.001
71119366|NCT00433160|141743946|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Last Measurement. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in PINP from baseline to the last measurement point between the two treatment groups.||||<0.001
71119367|NCT00433160|141743947|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 4. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in BAP after 4-week treatment between the two treatment groups.||||<0.001
71119368|NCT00433160|141743947|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 12. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in BAP after 12-week treatment between the two treatment groups.||||<0.001
71119369|NCT00433160|141743947|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 24. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in BAP after 24-week treatment between the two treatment groups.||||<0.001
71119370|NCT00433160|141743947|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||P-value for Percent Change to Week 52. No adjustment for multiplicity was performed.|Wicoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in BAP after 52-week treatment between the two treatment groups.||||0.060
71119371|NCT00433160|141743947|SUPERIORITY_OR_OTHER|||||||0.13||95.0||||P-value for Percent Change to Last Measurement. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in BAP from baseline to the last measurement point between the two treatment groups.||||0.130
71119372|NCT00433160|141743948|SUPERIORITY_OR_OTHER|||||||0.976||95.0||||P-value for Percent Change to Week 4. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in CTX after 4-week treatment between the two treatment groups.||||0.976
71119373|NCT00433160|141743948|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 12. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in CTX after 12-week treatment between the two treatment groups.||||<0.001
71119374|NCT00433160|141743948|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 24. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in CTX after 24-week treatment between the two treatment groups.||||<0.001
71119375|NCT00433160|141743948|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 52. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in CTX after 52-week treatment between the two treatment groups.||||<0.001
71119376|NCT00433160|141743948|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Last Measurement. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in CTX from baseline to the last measurement point between the two treatment groups.||||<0.001
71119377|NCT02499900|141743971|SUPERIORITY||Mean Difference (Final Values)|0.321|||<|0.001|TWO_SIDED|95.0|0.1615|0.4814||0.05 level of significance|Repeated Measures ANCOVA|||Estimates and p-value are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: MSQ=baseline MSQ score+treatment+visit+treatment by visit interaction. Treatment-naïve patients are not included in this analysis as MSQ is not measured at baseline for these patients.||0.4814|0.1615|<0.001
71119378|NCT02499900|141743972|SUPERIORITY||Mean Difference (Final Values)|9.448|||<|0.001|TWO_SIDED|95.0|6.9538|11.9429||0.05 level of significance|Repeated Measures ANCOVA|||Estimates and p-value are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: TSQM-9 convenience score=baseline TSQM-9 convenience score+treatment+CGR+treatment by visit interaction. Treatment-naïve patients are not included in this analysis as TSQM-9 is not measured at baseline for these patients.||11.9429|6.9538|<0.001
71119379|NCT02499900|141743973|SUPERIORITY||Mean Difference (Final Values)|-0.802||||0.208|TWO_SIDED|95.0|-2.05|0.4461||0.05 level of significance|Repeated Measures ANCOVA|||MFIS Total Score Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MFIS score=baseline MFIS score+treatment+visit +CGR+treatment by visit interaction.||0.4461|-2.0500|0.208
71119380|NCT02499900|141743973|SUPERIORITY||Mean Difference (Final Values)|-0.231||||0.47|TWO_SIDED|95.0|-0.8588|0.3962||0.05 level of significance|Repeated Measures ANCOVA|||MFIS Physical Subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MFIS score=baseline MFIS score+treatment+visit +CGR+treatment by visit interaction.||0.3962|-0.8588|0.470
71119381|NCT02499900|141743973|SUPERIORITY||Mean Difference (Final Values)|-0.639||||0.043|TWO_SIDED|95.0|-1.2564|-0.0214||0.05 level of significance|Repeated Measures ANCOVA|||MFIS Cognitive Subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MFIS score=baseline MFIS score+treatment+visit +CGR+treatment by visit interaction.||-0.0214|-1.2564|0.043
71119382|NCT02499900|141743973|SUPERIORITY||Mean Difference (Final Values)|0.102||||0.237|TWO_SIDED|95.0|-0.0672|0.2711||0.05 level of significance|Repeated Measures ANCOVA|||MFIS Psychosocial Subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MFIS score=baseline MFIS score+treatment+visit +CGR+treatment by visit interaction.||0.2711|-0.0672|0.237
70872008|NCT04617509|141229429|SUPERIORITY|Relative bioavailability for Formulation A (FED) versus Formulation A (FASTED). The calculated relative bioavailability is based on AUC0-inf ratio (ratio of geometric means) and is presented with 90% CI.|Ratio of geometric mean|0.7327|||||TWO_SIDED|90.0|0.591|0.9083||||||Relative bioavailability (A FED versus A FASTED)||0.9083|0.5910|
70854834|NCT01087788|141198145|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.09|=|0.017|TWO_SIDED|95.0|-0.38|-0.04||Difference of CZP 200 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline mTSS score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints.Conditional on the 1st test being significant, the 2nd hypothesis was tested with the same alpha level of 5%. Stat. testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected Re-analysis approach, restricted to subjects in the RS who have at least 2 x-ray values at scheduled visits (at least 8 wks apart)||-0.04|-0.38|=0.017
70854835|NCT01087788|141198145|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.09|=|0.261|TWO_SIDED|95.0|-0.27|0.07||Difference of CZP 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline mTSS score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints.Conditional on the 1st test being significant, the 2nd hypothesis was tested with the same alpha level of 5%. Stat. testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected Re-analysis approach, restricted to subjects in the RS who have at least 2 x-ray values at scheduled visits (at least 8 wks apart)||0.07|-0.27|=0.261
70854836|NCT01087788|141198146|SUPERIORITY_OR_OTHER||Difference in Percentages|40.2|||<|0.001|TWO_SIDED|95.0|29.5|51.0||Difference of Certolizumab Pegol 200 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||51.0|29.5|<0.001
70854837|NCT01087788|141198146|SUPERIORITY_OR_OTHER||Difference in Percentages|32.8|||<|0.001|TWO_SIDED|95.0|21.8|43.8||Difference of Certolizumab Pegol 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||43.8|21.8|<0.001
70854838|NCT01087788|141198147|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.42|-0.2||Difference of CZP 200 mg + 400 mg vs. Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline HAQ-DI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-0.20|-0.42|<0.001
70854839|NCT01087788|141198148|SUPERIORITY_OR_OTHER||Difference in Percentages|46.3|||<|0.001|TWO_SIDED|95.0|35.7|56.9||Difference of Certolizumab Pegol 200 mg + 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||56.9|35.7|<0.001
70854840|NCT01087788|141198149|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.12|=|0.127|TWO_SIDED|95.0|-0.43|0.05||Difference of CZP 200 mg + 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline mTSS score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected. This is the predefined analysis.||0.05|-0.43|=0.127
70872009|NCT04617509|141229430|SUPERIORITY|Relative bioavailability for Formulation A (FASTED) versus Formulation B (FASTED). The calculated relative bioavailability is based on AUC0-24h ratio (ratio of geometric means) and is presented with 90% CI.|Ratio of geometric mean|1.371|||||TWO_SIDED|90.0|1.112|1.6904||||||Relative bioavailability (A versus B)||1.6904|1.1120|
70943562|NCT01040403|141387588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.06|0.059|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-3h||0.059|-0.060|
71080622|NCT03749109|141667650|OTHER||Rate Ratio|2.53||||0.13|TWO_SIDED|95.0|0.76|8.39|||Negative-binomial regression|||Endometrioma - Disappearing Lesions||8.39|0.76|0.13
71080623|NCT03749109|141667650|OTHER||Rate Ratio|0.49||||0.56|TWO_SIDED|95.0|0.04|5.41|||Negative-binomial regression|||Adenomyosis - Disappearing Lesions||5.41|0.04|0.56
71080624|NCT03749109|141667651|OTHER||Difference in LS mean|0.23||||0.97|TWO_SIDED|95.0|-12.78|13.23|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma||13.23|-12.78|0.97
71080625|NCT03749109|141667651|OTHER||Difference in LS mean|0.72||||0.74|TWO_SIDED|95.0|-3.63|5.07|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE||5.07|-3.63|0.74
71080626|NCT03749109|141667652|OTHER||Difference in LS mean|10.13||||0.42|TWO_SIDED|95.0|-14.74|35.0|||ANCOVA|ANCOVA adjusted for baseline lesion size.||||35.00|-14.74|0.42
71080627|NCT03749109|141667653|OTHER||Difference in LS mean|1.09||||0.1|TWO_SIDED|95.0|-0.2|2.38|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma||2.38|-0.20|0.10
71080628|NCT03749109|141667653|OTHER||Difference in LS mean|0.28||||0.67|TWO_SIDED|95.0|-1.02|1.58|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE||1.58|-1.02|0.67
71119383|NCT02499900|141743974|SUPERIORITY||Mean Difference (Final Values)|0.706||||0.287|TWO_SIDED|95.0|-0.5947|1.0074||0.05 level of significance|Repeated Measures ANCOVA|||Total Score Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MHI score=baseline MHI Total Score +treatment +visit +country/geographic region +treatment by visit interaction.||1.0074|-0.5947|0.287
71119384|NCT02499900|141743974|SUPERIORITY||Mean Difference (Final Values)|0.141||||0.868|TWO_SIDED|95.0|-1.5179|1.7991||0.05 level of significance|Repeated Measures ANCOVA|||Anxiety subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MHI score=baseline MHI Total Score +treatment +visit +country/geographic region +treatment by visit interaction.||1.7991|-1.5179|0.868
71119385|NCT02499900|141743974|SUPERIORITY||Mean Difference (Final Values)|0.481||||0.544|TWO_SIDED|95.0|-1.0734|2.0348||0.05 level of significance|Repeated Measures ANCOVA|||Depression subscale estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MHI score=baseline MHI Total Score +treatment +visit +country/geographic region +treatment by visit interaction.||2.0348|-1.0734|0.544
71119386|NCT02499900|141743974|SUPERIORITY||Mean Difference (Final Values)|1.867||||0.014|TWO_SIDED|95.0|0.3843|3.3487||0.05 level of significance|Repeated Measures ANCOVA|||Behavioral Control subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MHI score=baseline MHI Total Score +treatment +visit +country/geographic region +treatment by visit interaction.||3.3487|0.3843|0.014
71119387|NCT02499900|141743974|SUPERIORITY||Mean Difference (Final Values)|-0.092||||0.919|TWO_SIDED|95.0|-1.8565|1.6728||0.05 level of significance|Repeated Measures ANCOVA|||MHI Positive Affect subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MHI score=baseline MHI Total Score +treatment +visit +country/geographic region +treatment by visit interaction.||1.6728|-1.8565|0.919
71119388|NCT02499900|141743975|SUPERIORITY||Mean Difference (Final Values)|-0.059||||0.851|TWO_SIDED|95.0|-0.6777|0.5592||0.05 level of significance|Repeated Measures ANCOVA|||Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline BDI-II total score=baseline BDI-II total score+treatment+visit+country/geographic region +treatment by visit interaction.||0.5592|-0.6777|0.851
71119389|NCT03998670|141743977|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.5|1.1|||||Difference in mean control and 95% confidence interval (CI) are from ANCOVA model adjusting for corresponding baseline control score. Prism group minus Non-Prism group (positive difference indicates Prism group worse than Non-Prism group).|The primary analysis was the treatment group difference (and 95% CI) in mean distance control at the 8-week outcome visit using an ANCOVA adjusted for baseline distance control. The planned convenience sample size of 64 was expected to provide outcome data for at least 60 participants (30 per group).||1.1|-0.5|
71119390|NCT03998670|141743978|SUPERIORITY||Mean Difference (Final Values)|8.0|||||TWO_SIDED|95.0|-17.0|32.0|||||Difference between Prism minus Non-Prism group (positive difference indicates Prism group better than Non-Prism group).|||32|-17|
71119391|NCT03998670|141743979|SUPERIORITY||Mean Difference (Final Values)|-4.0|||||TWO_SIDED|95.0|-27.0|19.0|||||Difference between Prism minus Non-Prism group (positive difference indicates Prism group better than Non-Prism group).|||19|-27|
71119392|NCT03998670|141743981|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.7|0.7|||||Difference in mean control and 95% confidence interval (CI) are from ANCOVA model adjusting for corresponding baseline control score. Prism group minus Non-Prism group (positive difference indicates Prism group worse than Non-Prism group).|The secondary analysis was the treatment group difference (and 95% CI) in mean near control at the 8-week outcome visit using an ANCOVA adjusted for baseline near control.||0.7|-0.7|
71119393|NCT05858450|141744029|OTHER||Weighted Hazard Ratio|1.108|||||TWO_SIDED|95.0|1.018|1.205||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an inverse probability of treatment weights (IPTW) was applied. Analysis performed using IPTW method.||1.205|1.018|
71119394|NCT05858450|141744029|OTHER||Weighted Hazard Ratio|0.634|||||TWO_SIDED|95.0|0.606|0.664||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||0.664|0.606|
71119395|NCT05858450|141744030|OTHER||Weighted Hazard Ratio|1.061|||||TWO_SIDED|95.0|1.016|1.107||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.107|1.016|
71119396|NCT05858450|141744030|OTHER||Weighted Hazard Ratio|0.897|||||TWO_SIDED|95.0|0.875|0.919||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||0.919|0.875|
71119397|NCT05858450|141744031|OTHER||Weighted Hazard Ratio|1.543|||||TWO_SIDED|95.0|1.133|2.1||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||2.1|1.133|
71119398|NCT05858450|141744031|OTHER||Weighted Hazard Ratio|1.106|||||TWO_SIDED|95.0|1.014|1.206||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.206|1.014|
71119399|NCT05858450|141744032|OTHER||Weighted Hazard Ratio|1.048|||||TWO_SIDED|95.0|0.903|1.217||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.217|0.903|
70872010|NCT04617509|141229430|SUPERIORITY|Relative bioavailability for Formulation A (FED) versus Formulation A (FASTED). The calculated relative bioavailability is based on AUC0-24h ratio (ratio of geometric means) and is presented with 90% CI.|Ratio of geometric mean|0.7083|||||TWO_SIDED|90.0|0.5728|0.8759||||||Relative bioavailability (A FED versus A FASTED)||0.8759|0.5728|
71119400|NCT05858450|141744032|OTHER||Weighted Hazard Ratio|0.908|||||TWO_SIDED|95.0|0.846|0.973||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||0.973|0.846|
71119401|NCT05858450|141744033|OTHER||Weighted Hazard Ratio|1.137|||||TWO_SIDED|95.0|1.068|1.211||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.211|1.068|
71119402|NCT05858450|141744033|OTHER||Weighted Hazard Ratio|1.057|||||TWO_SIDED|95.0|1.007|1.11||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.11|1.007|
70943563|NCT01040403|141387588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.035|0.083|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-3h||0.083|-0.035|
71080629|NCT03749109|141667653|OTHER||Difference in LS mean|0.32||||0.64|TWO_SIDED|95.0|-1.06|1.71|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis||1.71|-1.06|0.64
70872011|NCT00790023|141229440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94|||<|0.0001|TWO_SIDED|95.0|0.57|1.32||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in rTNSS with a two-sided alpha level of 0.025.||1.32|0.57|<0.0001
70943564|NCT01040403|141387588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.035|0.083|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-3h||0.083|-0.035|
71080630|NCT03749109|141667654|OTHER||Difference in LS mean|0.21||||0.73|TWO_SIDED|95.0|-1.02|1.44|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma at cycle 1||1.44|-1.02|0.73
71080631|NCT03749109|141667654|OTHER||Difference in LS mean|0.42||||0.54|TWO_SIDED|95.0|-0.97|1.82|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma at cycle 2||1.82|-0.97|0.54
71080632|NCT03749109|141667654|OTHER||Difference in LS mean|-0.5||||0.46|TWO_SIDED|95.0|-1.86|0.85|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma at cycle 3||0.85|-1.86|0.46
70943565|NCT01040403|141387588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|0.081|0.197|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-6h||0.197|0.081|
70943566|NCT01040403|141387588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|0.092|0.207|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-6h||0.207|0.092|
70943567|NCT01040403|141387588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|0.073|0.189|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-6h||0.189|0.073|
70943568|NCT01040403|141387588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.047|0.068|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-6h||0.068|-0.047|
70943569|NCT01040403|141387588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.066|0.051|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-6h||0.051|-0.066|
70943570|NCT01040403|141387588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.018|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.076|0.039|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-6h||0.039|-0.076|
70943571|NCT01040403|141387588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.189|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|0.131|0.247|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-6h||0.247|0.131|
70943572|NCT01040403|141387588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.179|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|0.121|0.236|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-6h||0.236|0.121|
70943573|NCT01040403|141387588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|0.155|0.271|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-6h||0.271|0.155|
70943574|NCT01040403|141387588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.069|0.048|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-6h||0.048|-0.069|
70943575|NCT01040403|141387588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.033|0.082|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-6h||0.082|-0.033|
70943576|NCT01040403|141387588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.023|0.092|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-6h||0.092|-0.023|
70943577|NCT01040403|141387589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.048|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.106|0.01|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.010|-0.106|
70943578|NCT01040403|141387589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.065|0.051|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.051|-0.065|
70943579|NCT01040403|141387589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.072|0.044|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.044|-0.072|
70943580|NCT01040403|141387589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.041|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.017|0.099|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.099|-0.017|
70943581|NCT01040403|141387589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.034|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.024|0.093|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.093|-0.024|
70943582|NCT01040403|141387589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.065|0.051|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.051|-0.065|
70943583|NCT01040403|141387589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.032|0.148|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.148|0.032|
71080633|NCT03749109|141667654|OTHER||Difference in LS mean|0.53||||0.49|TWO_SIDED|95.0|-0.99|2.05|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma at cycle 4||2.05|-0.99|0.49
71080634|NCT03749109|141667654|OTHER||Difference in LS mean|-0.01||||0.99|TWO_SIDED|95.0|-1.32|1.3|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE at cycle 1||1.30|-1.32|0.99
71080635|NCT03749109|141667654|OTHER||Difference in LS mean|0.17||||0.83|TWO_SIDED|95.0|-1.38|1.71|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE at cycle 2||1.71|-1.38|0.83
71080636|NCT03749109|141667654|OTHER||Difference in LS mean|-0.74||||0.28|TWO_SIDED|95.0|-2.11|0.63|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE at cycle 3||0.63|-2.11|0.28
71080637|NCT03749109|141667654|OTHER||Difference in LS mean|0.75||||0.26|TWO_SIDED|95.0|-0.57|2.07|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE at cycle 4||2.07|-0.57|0.26
71080638|NCT03749109|141667654|OTHER||Difference in LS mean|0.91||||0.19|TWO_SIDED|95.0|-0.49|2.31|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis at cycle 1||2.31|-0.49|0.19
71080639|NCT03749109|141667654|OTHER||Difference in LS mean|0.07||||0.93|TWO_SIDED|95.0|-1.45|1.58|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis at cycle 2||1.58|-1.45|0.93
71080640|NCT03749109|141667654|OTHER||Difference in LS mean|-0.13||||0.85|TWO_SIDED|95.0|-1.58|1.32|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis at cycle 3||1.32|-1.58|0.85
71080641|NCT03749109|141667654|OTHER||Difference in LS mean|0.01||||0.99|TWO_SIDED|95.0|-1.68|1.69|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis at cycle 4||1.69|-1.68|0.99
70943584|NCT01040403|141387589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.001|0.118|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.118|0.001|
71080642|NCT03749109|141667655|OTHER||Difference in LS mean|-7.35||||0.75|TWO_SIDED|95.0|-53.97|39.27|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma at cycle 2||39.27|-53.97|0.75
71080643|NCT03749109|141667655|OTHER||Difference in LS mean|17.31||||0.42|TWO_SIDED|95.0|-25.41|60.04|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma at cycle 4||60.04|-25.41|0.42
71080644|NCT03749109|141667655|OTHER||Difference in LS mean|-17.66||||0.47|TWO_SIDED|95.0|-66.3|30.98|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE at cycle 2||30.98|-66.30|0.47
71080645|NCT03749109|141667655|OTHER||Difference in LS mean|25.61||||0.27|TWO_SIDED|95.0|-21.05|72.27|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE at cycle 4||72.27|-21.05|0.27
71080646|NCT03749109|141667655|OTHER||Difference in LS mean|-20.95||||0.41|TWO_SIDED|95.0|-71.83|29.92|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis at cycle 2||29.92|-71.83|0.41
71080647|NCT03749109|141667655|OTHER||Difference in LS mean|2.25||||0.93|TWO_SIDED|95.0|-49.57|54.06|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis at cycle 4||54.06|-49.57|0.93
71080648|NCT03951753|141667705|OTHER||Least Squares Mean Difference|1.08|STANDARD_ERROR_OF_MEAN|0.107|<|0.001|TWO_SIDED|95.0|0.87|1.29|||ANCOVA|Data were analysed with ANCOVA in log transformed data.|Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.|||1.29|0.87|<0.001
71080649|NCT03951753|141667705|OTHER||Least Squares Mean Difference|1.92|STANDARD_ERROR_OF_MEAN|0.166|<|0.001|TWO_SIDED|95.0|1.59|2.24|||ANCOVA|Data were analysed with ANCOVA in log transformed data.|Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.|||2.24|1.59|<0.001
71080650|NCT03951753|141667705|OTHER||Least Squares Mean Difference|0.84|STANDARD_ERROR_OF_MEAN|0.192|<|0.001|TWO_SIDED|95.0|0.46|1.21|||ANCOVA|Data were analysed with ANCOVA in log transformed data.|Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.|||1.21|0.46|<0.001
71080651|NCT03951753|141667706|OTHER||Least Squares Mean Difference|-38.1|||<|0.001|TWO_SIDED|95.0|-45.4|-30.7|||ANCOVA|||||-30.7|-45.4|<0.001
71080652|NCT03951753|141667706|OTHER||Least Squares Mean Difference|-47.1|||<|0.001|TWO_SIDED|95.0|-54.6|-39.5|||ANCOVA|||||-39.5|-54.6|<0.001
71080653|NCT03951753|141667706|OTHER||Least Squares Mean Difference|-9.0||||0.006|TWO_SIDED|95.0|-15.4|-2.6|||ANCOVA|||||-2.6|-15.4|0.006
71080654|NCT03951753|141667707|OTHER||Least Squares Mean Difference|-14696.1|||<|0.001|TWO_SIDED|95.0|-17045.0|-12347.3|||ANCOVA|||||-12347.3|-17045.0|<0.001
71080655|NCT03951753|141667707|OTHER||Least Squares Mean Difference|-17873.2|||<|0.001|TWO_SIDED|95.0|-20239.0|-15507.4|||ANCOVA|||||-15507.4|-20239.0|<0.001
71080656|NCT03951753|141667707|OTHER||Least Squares Mean Difference|-3177.1||||0.002|TWO_SIDED|95.0|-5194.3|-1159.8|||ANCOVA|||||-1159.8|-5194.3|0.002
71080657|NCT03951753|141667708|OTHER||Least Squares Mean Difference|-1.93|||<|0.001|TWO_SIDED|95.0|-2.18|-1.67|||Mixed Models Analysis|||||-1.67|-2.18|<0.001
71080658|NCT03951753|141667708|OTHER||Least Squares Mean Difference|-2.33|||<|0.001|TWO_SIDED|95.0|-2.58|-2.08|||Mixed Models Analysis|||||-2.08|-2.58|<0.001
71080659|NCT03951753|141667708|OTHER||Least Squares Mean Difference|-0.41|||<|0.001|TWO_SIDED|95.0|-0.63|-0.19|||Mixed Models Analysis|||||-0.19|-0.63|<0.001
71080660|NCT03951753|141667709|OTHER||Least Squares Mean Difference|279.14|STANDARD_ERROR_OF_MEAN|17.366|<|0.001|TWO_SIDED|95.0|245.1|313.18|||ANCOVA|Data were analysed with ANCOVA in log transformed data.|Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.|||313.18|245.10|<0.001
71080661|NCT03951753|141667709|OTHER||Least Squares Mean Difference|381.23|STANDARD_ERROR_OF_MEAN|21.399|<|0.001|TWO_SIDED|95.0|339.29|423.17|||ANCOVA|Data were analysed with ANCOVA in log transformed data.|Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.|||423.17|339.29|<0.001
71080662|NCT03951753|141667709|OTHER||Least Squares Mean Difference|102.09|STANDARD_ERROR_OF_MEAN|25.635|<|0.001|TWO_SIDED|95.0|51.84|152.33|||ANCOVA|Data were analysed with ANCOVA in log transformed data.|Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.|||152.33|51.84|<0.001
71080663|NCT03951753|141667710|OTHER||Least Squares Mean Difference|11.3|||<|0.001|TWO_SIDED|95.0|4.9|17.7|||ANCOVA|||||17.7|4.9|<0.001
71080664|NCT03951753|141667710|OTHER||Least Squares Mean Difference|19.8|||<|0.001|TWO_SIDED|95.0|13.4|26.1|||ANCOVA|||||26.1|13.4|<0.001
71080665|NCT03951753|141667710|OTHER||Least Squares Mean Difference|8.5||||0.003|TWO_SIDED|95.0|3.0|14.0|||ANCOVA|||||14.0|3.0|0.003
71080666|NCT03951753|141667711|OTHER||Least Squares Mean Difference|-3.6|||<|0.001|TWO_SIDED|95.0|-5.5|-1.8|||ANCOVA|||||-1.8|-5.5|<0.001
71080667|NCT03951753|141667711|OTHER||Least Squares Mean Difference|-4.5|||<|0.001|TWO_SIDED|95.0|-6.3|-2.6|||ANCOVA|||||-2.6|-6.3|<0.001
70854841|NCT01087788|141198149|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.26|=|0.048|TWO_SIDED|95.0|-1.04|-0.01||Difference of CZP 200 mg + 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline mTSS score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected. This is the post-hoc analysis for the subgroup 'Baseline mTSS \> 6'.||-0.01|-1.04|=0.048
70943585|NCT01040403|141387589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.002|0.114|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.114|-0.002|
70943586|NCT01040403|141387589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.031|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.089|0.028|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.028|-0.089|
70854842|NCT01779219|141198152|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Fisher's exact test (two-tailed)|Fisher Exact|||||||1.0
70854843|NCT01779219|141198153|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0
70943587|NCT01040403|141387589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.034|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.092|0.024|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.024|-0.092|
71080668|NCT03951753|141667711|OTHER||Least Squares Mean Difference|-0.8||||0.277|TWO_SIDED|95.0|-2.4|0.7|||ANCOVA|||||0.7|-2.4|0.277
70854844|NCT01779219|141198154|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Total length of hospital stay||||0.16
70854845|NCT01779219|141198154|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Length of the preoperative hospital stay||||0.73
70854846|NCT01779219|141198154|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Length of the postoperative hospital stay||||1.0
70854847|NCT01779219|141198155|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Total OR time||||<0.001
70854848|NCT01779219|141198155|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Time of preoperative preparations||||0.004
70854849|NCT01779219|141198155|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"Time of the operation (skin-to-skin)"||||0.024
71080669|NCT03951753|141667712|OTHER||Slope|-296.1||||0.044|TWO_SIDED|95.0|-584.8|-7.5|||ANCOVA|||||-7.5|-584.8|0.044
71080670|NCT03951753|141667712|OTHER||Least Squares Mean Difference|-637.7|||<|0.001|TWO_SIDED|95.0|-925.2|-350.2|||ANCOVA|||||-350.2|-925.2|<0.001
71080671|NCT03951753|141667712|OTHER||Least Squares Mean Difference|-341.6||||0.006|TWO_SIDED|95.0|-585.2|-97.9|||ANCOVA|||||-97.9|-585.2|0.006
71080672|NCT03951753|141667713|OTHER||Least Squares Mean Difference|-245.5|||<|0.001|TWO_SIDED|95.0|-357.7|-133.3|||Mixed Models Analysis|||||-133.3|-357.7|<0.001
71119403|NCT05858450|141744034|OTHER||Weighted Hazard Ratio|0.761|||||TWO_SIDED|95.0|0.718|0.807||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||0.807|0.718|
71080673|NCT03951753|141667713|OTHER||Least Squares Mean Difference|-309.8|||<|0.001|TWO_SIDED|95.0|-423.0|-196.6|||Mixed Models Analysis|||||-196.6|-423.0|<0.001
71080674|NCT03951753|141667713|OTHER||Least Squares Mean Difference|-64.3||||0.187|TWO_SIDED|95.0|-160.3|31.7|||Mixed Models Analysis|||||31.7|-160.3|0.187
71080675|NCT04633291|141667714|NON_INFERIORITY|Based on previous studies, the weighted average VAS discomfort level in healthy subjects using SpeediCath®Standard Male was estimated at 2.3 cm, with 50% increase in VAS was considered clinically relevant. The mean difference non-inferiority margin between catheter coatings was therefore set to 1.2 cm, and non-inferiority was demonstrated if the mean difference was not above 1.2 cm.|Mean Difference (Final Values)|0.04||||0.88|TWO_SIDED|95.0|-0.5|0.58||The threshold for statistical significance was set at 0.05|Mixed Models Analysis|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.||At a 85% power level, the sample size needed to demonstrate non-inferiority of the novel coating to the original the coating was 18 subjects (participants). This was based on a standard deviation of 1.6 cm, a within subject correlation of 0.5 cm, and an assumption of same VAS distribution for the investigational device as for the comparator. With an expected drop-out rate of 20%, 22 subjects were included.||0.58|-0.50|0.88
71080676|NCT04633291|141667715|NON_INFERIORITY|Based on previous studies, the weighted average VAS discomfort level in healthy subjects using SpeediCath®Standard male was estimated at 2.3 cm, with 50% increase in VAS was considered clinically relevant. The mean difference non-inferiority margin between catheter coatings was therefore set to 1.2 cm, and non-inferiority was demonstrated if the mean difference was not above 1.2 cm.|Mean Difference (Final Values)|-0.14||||0.62|TWO_SIDED|95.0|-0.72|0.44||The threshold for statistical significance was set at 0.05.|Mixed Models Analysis|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.||At a 85% power level, the sample size needed to demonstrate non-inferiority of the novel coating to the original the coating was 18 subjects (participants). This was based on a standard deviation of 1.6 cm, a within subject correlation of 0.5 cm, and an assumption of same VAS distribution for the investigational device as for the comparator. With an expected drop-out rate of 20%, 22 subjects were included.||0.44|-0.72|0.62
71080677|NCT04633291|141667716|NON_INFERIORITY|Based on previous studies, the weighted average VAS discomfort level in healthy subjects using SpeediCath®Standard male was estimated at 2.3 cm, with 50% increase in VAS was considered clinically relevant. The mean difference non-inferiority margin between catheter coatings was therefore set to 1.2 cm, and non-inferiority was demonstrated if the mean difference was not above 1.2 cm.|Mean Difference (Final Values)|0.11||||0.63|TWO_SIDED|95.0|-0.36|0.57||The threshold for statistical significance was set at 0.05.|Mixed Models Analysis|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.||At a 85% power level, the sample size needed to demonstrate non-inferiority of the novel coating to the original the coating was 18 subjects (participants). This was based on a standard deviation of 1.6 cm, a within subject correlation of 0.5 cm, and an assumption of same VAS distribution for the investigational device as for the comparator. With an expected drop-out rate of 20%, 22 subjects were included.||0.57|-0.36|0.63
71080678|NCT04633291|141667717|NON_INFERIORITY|Based on previous studies, the weighted average VAS discomfort level in healthy subjects using SpeediCath®Standard male was estimated at 2.3 cm, with 50% increase in VAS was considered clinically relevant. The mean difference non-inferiority margin between catheter coatings was therefore set to 1.2 cm, and non-inferiority was demonstrated if the mean difference was not above 1.2 cm.|Mean Difference (Final Values)|-0.15||||0.19|TWO_SIDED|95.0|-0.38|0.08||The threshold for statistical significance was set at 0.05.|Mixed Models Analysis|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.||At a 85% power level, the sample size needed to demonstrate non-inferiority of the novel coating to the original the coating was 18 subjects (participants). This was based on a standard deviation of 1.6 cm, a within subject correlation of 0.5 cm, and an assumption of same VAS distribution for the investigational device as for the comparator. With an expected drop-out rate of 20%, 22 subjects were included.||0.08|-0.38|0.19
71080679|NCT04633291|141667718|SUPERIORITY||Odds Ratio (OR)|1.76||||0.381|TWO_SIDED|95.0|0.47|6.6||The threshold for statistical significance was set at 0.05.|Proportional odds model|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.|OR=1 corresponds to exact equality. OR \>1 means that the investigational device is evaluated easier than the comparator. OR \<1 means that the comparator device is evaluated easier than the investigational device.|Null hypothesis: No difference between the devices.||6.60|0.47|0.381
71119404|NCT05858450|141744034|OTHER||Weighted Hazard Ratio|0.858|||||TWO_SIDED|95.0|0.811|0.907||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||0.907|0.811|
70854850|NCT00534313|141198163|SUPERIORITY_OR_OTHER||Difference|22.9||||0.022|TWO_SIDED|95.0|4.0|41.8||The p-value (two-sided) was based on Cochran-Mantel-Haenszel method (CMH) with stratification of baseline body surface area (BSA) affected by psoriasis.|Cochran-Mantel-Haenszel||Difference was based on CMH with stratification of baseline BSA affected by psoriasis.|||41.8|4.0|0.022
70943588|NCT01040403|141387589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.062|0.055|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.055|-0.062|
70854851|NCT00534313|141198163|SUPERIORITY_OR_OTHER||Difference|28.7||||0.006|TWO_SIDED|95.0|9.4|48.0||p-value (two-sided) was based on CMH with stratification of baseline BSA affected by psoriasis.|Cochran-Mantel-Haenszel||Difference was based on CMH with stratification of baseline BSA affected by psoriasis.|||48.0|9.4|0.006
70854852|NCT00534313|141198163|SUPERIORITY_OR_OTHER||Difference|14.6||||0.121|TWO_SIDED|95.0|-3.5|32.6||p-value (2-sided) was based on CMH with stratification of baseline BSA affected by psoriasis.|Cochran-Mantel-Haenszel||Difference was based on CMH with stratification of baseline BSA affected by psoriasis.|||32.6|-3.5|0.121
70854853|NCT00534313|141198170|SUPERIORITY_OR_OTHER||Difference|-6.0|||||TWO_SIDED|95.0|-23.0|11.0|||Cochran-Mantel-Haenszel||Difference and 95% confidence intervals (CI) was based on CMH with stratification of baseline BSA affected by psoriasis.|||11.0|-23.0|
71080680|NCT04633291|141667719|SUPERIORITY||Odds Ratio (OR)|7.8||||0.541|TWO_SIDED|95.0|-18.4|34.0||The threshold for statistical significance was set at 0.05.|Proportional odds model|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.|"OR=1 corresponds to exact equality. OR \>1 means that the investigational device is evaluated easier than the comparator. OR \<1 means that the comparator device is evaluated easier than the investigational device.~Of note: Log transformed estimates."|Null hypothesis: No difference between the devices.||34.00|-18.40|0.541
71080681|NCT04633291|141667720|SUPERIORITY||Odds Ratio (OR)|7.17||||0.269|TWO_SIDED|95.0|0.19|265.95||The threshold for statistical significance was set at 0.05.|Regression, Logistic|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.|OR=1 corresponds to exact equality. OR \>1 means that the investigational device is in favor compared to the comparator. OR \<1 means that the comparator device is in favor compared to the investigational device.|Null hypothesis: No difference between the devices.||265.95|0.19|0.269
71080682|NCT04633291|141667721|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.02|64.83||The threshold for statistical significance was set at 0.05.|Regression, Logistic|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.|OR=1 corresponds to exact equality. OR \>1 means that the investigational device is in favor compared to the comparator. OR \<1 means that the comparator device is in favor compared to the investigational device.|Null hypothesis: No difference between the devices.||64.83|0.02|1.0
71080683|NCT04633291|141667722|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.08|12.87||The threshold for statistical significance was set at 0.05.|Regression, Logistic|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.|OR=1 corresponds to exact equality. OR \>1 means that the investigational device is in favor compared to the comparator. OR \<1 means that the comparator device is in favor compared to the investigational device.|Null hypothesis: No difference between the devices.||12.87|0.08|1.0
70854854|NCT00534313|141198170|SUPERIORITY_OR_OTHER||Difference|-0.5|||||TWO_SIDED|95.0|-18.0|17.1|||Cochran-Mantel-Haenszel||Difference and 95% CI was based on CMH with stratification of baseline BSA affected by psoriasis.|||17.1|-18.0|
71080684|NCT01037816|141667742|SUPERIORITY|||||||0.137|||||||ANCOVA|||The treatment effect of the FS-67 patch was estimated by computing the difference in LS means of the FS-67 and placebo patches from the ANCOVA model||||0.137
71080685|NCT01037816|141667743|SUPERIORITY|||||||0.044|||||||ANCOVA|||||||0.044
71080686|NCT01133704|141667746|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.719|TWO_SIDED|95.0|0.69|1.7|||Log Rank||Obtained from a Cox proportional hazards model with treatment group as the independent variable, stratified by bisphosphonate use (placebo/sipuleucel-T)|||1.70|0.69|0.719
71080687|NCT01133704|141667747|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.27||||0.331|TWO_SIDED|95.0|0.78|2.07|||Log Rank||Obtained from a Cox proportional hazards model with treatment as the independent variable, and stratified by bisphosphonate use (placebo/sipuleucel-T).|||2.07|0.78|0.331
70854855|NCT00534313|141198170|SUPERIORITY_OR_OTHER||Difference|10.4|||||TWO_SIDED|95.0|-7.6|28.5|||Cochran-Mantel-Haenszel||Difference and 95% CI was based on CMH with stratification of baseline BSA affected by psoriasis.|||28.5|-7.6|
70943589|NCT01040403|141387590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|0.087|0.223|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.223|0.087|
70854856|NCT00534313|141198171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.77|||||TWO_SIDED|95.0|-7.02|44.56|||ANCOVA|||||44.56|-7.02|
70943590|NCT01040403|141387590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|0.079|0.215|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.215|0.079|
71080688|NCT00136214|141667748|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in basal ganglia Comparison on MR spectroscopy of Cho/Cr at time points 1,2 and 3||||0.08
71080689|NCT00136214|141667748|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in basal ganglia Comparison on MR spectroscopy of Mi/Cr at time points 1,2 and 3||||0.3
71080690|NCT00136214|141667748|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in basal ganglia Comparison on MR spectroscopy of NAA/Cr at time points 1,2 and 3||||0.9
71080691|NCT00136214|141667748|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in frontal cortex. Comparison on MR spectroscopy of Cho/Cr at time points 1,2 and 3||||0.7
71119405|NCT05858450|141744035|OTHER||Weighted Hazard Ratio|1.55|||||TWO_SIDED|95.0|0.88|2.731||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||2.731|0.88|
71119406|NCT05858450|141744035|OTHER||Weighted Hazard Ratio|1.035|||||TWO_SIDED|95.0|0.865|1.238||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.238|0.865|
71119407|NCT05858450|141744036|OTHER||Weighted Hazard Ratio|0.921|||||TWO_SIDED|95.0|0.687|1.233||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.233|0.687|
71119408|NCT05858450|141744036|OTHER||Weighted Hazard Ratio|0.826|||||TWO_SIDED|95.0|0.722|0.945||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||0.945|0.722|
71119409|NCT05858450|141744037|OTHER||Weighted Hazard Ratio|1.569|||||TWO_SIDED|95.0|1.088|2.264||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||2.264|1.088|
71119410|NCT05858450|141744037|OTHER||Weighted Hazard Ratio|1.118|||||TWO_SIDED|95.0|1.015|1.233||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.233|1.015|
71119411|NCT05858450|141744038|OTHER||Weighted Hazard Ratio|1.082|||||TWO_SIDED|95.0|0.911|1.286||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.286|0.911|
71119412|NCT05858450|141744038|OTHER||Weighted Hazard Ratio|0.932|||||TWO_SIDED|95.0|0.859|1.01||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.01|0.859|
71119413|NCT00642174|141744044|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Net)|61.6|||<|0.0001||95.0|53.83|69.31||P-value is for 4 Hours After Loading Dose.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (i.e. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: there is no difference between prasugrel and clopidogrel in IPA assessed by Accumetrics VerifyNow™ P2Y12 4 hours after administration of loading dose. Assuming 90% power, 2-sided alpha of 0.05, and a 17.5% difference in IPA between treatment groups with a standard deviation of 20, a total of 15 completed subjects per sequence group (i.e., 15 subject who receive prasugrel first, then clopidogrel; and 15 subjects who receive clopidogrel first, then prasugrel) was determined.||69.31|53.83|<0.0001
71119414|NCT00642174|141744045|SUPERIORITY_OR_OTHER||Mean Difference (Net)|36.5|||<|0.0001||95.0|27.43|45.52||P-value for 1 Hour After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: there was no difference between prasugrel and clopidogrel in IPA assessed by Accumetrics VerifyNow™ P2Y12 1 hour after administration of the loading dose.||45.52|27.43|<0.0001
71119415|NCT00642174|141744045|SUPERIORITY_OR_OTHER||Mean Difference (Net)|57.9|||<|0.0001||95.0|49.56|66.19||P-value for 24 Hour After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: there was no difference between prasugrel and clopidogrel in IPA assessed by Accumetrics VerifyNow™ P2Y12 24 hours after administration of the loading dose.||66.19|49.56|<0.0001
71119416|NCT00642174|141744045|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.7|||<|0.0001||95.0|10.27|25.04||P-value for 24 Hours After Last Maintenance Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: there was no difference between prasugrel and clopidogrel in IPA assessed by Accumetrics VerifyNow™ P2Y12 24 hours post-Last Maintenance Dose (LMD).||25.04|10.27|<0.0001
71119417|NCT00642174|141744046|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.5466||95.0|-3.66|1.97||P-value for Baseline (5 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||1.97|-3.66|0.5466
70943591|NCT01040403|141387590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|0.058|0.195|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.195|0.058|
71080692|NCT00136214|141667748|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in frontal cortex. Comparison on MR spectroscopy of MI/Cr at time points 1,2 and 3||||0.4
71080693|NCT00136214|141667748|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in frontal cortex. Comparison on MR spectroscopy of NAA/Cr at time points 1,2 and 3||||0.6
71080694|NCT00136214|141667748|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in DLPFC. Comparison on MR spectroscopy of Cho/Cr at time points 1,2 and 3||||0.3
71080695|NCT00136214|141667748|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in DLPFC. Comparison on MR spectroscopy ofMI/Cr at time points 1,2 and 3||||0.3
71080696|NCT00136214|141667748|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in DLPFC. Comparison on MR spectroscopy of NAA/Cr at time points 1,2 and 3||||0.3
71080697|NCT00136214|141667748|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in Basal ganglia. Comparison on MR spectroscopy of Cho/Cr at time points 1 and 2||||0.4
71080698|NCT00136214|141667748|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in Basal ganglia. Comparison on MR spectroscopy of MI/Cr at time points 1 and 2||||0.9
71080699|NCT00136214|141667748|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in Basal ganglia. Comparison on MR spectroscopy of NAA/Cr at time points 1 and 2||||0.6
71119418|NCT00642174|141744046|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.0|||<|0.0001||95.0|-28.45|-17.55||P-value for 1 After Post Loading Dose (5 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-17.55|-28.45|<0.0001
70854857|NCT00534313|141198171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.34|||||TWO_SIDED|95.0|-3.93|48.6|||ANCOVA|||||48.60|-3.93|
70943592|NCT01040403|141387590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.075|0.06|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.060|-0.075|
71080700|NCT00136214|141667748|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in frontal cortex. Comparison on MR spectroscopy of Cho/Cr at time points 1 and 2||||0.7
71080701|NCT00136214|141667748|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in frontal cortex. Comparison on MR spectroscopy of MI/Cr at time points 1 and 2||||0.1
71080702|NCT00136214|141667748|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in frontal cortex. Comparison on MR spectroscopy of NAA/Cr at time points 1 and 2||||0.6
71080703|NCT00136214|141667748|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in DLPFC. Comparison on MR spectroscopy of Cho/Cr at time points 1 and 2||||0.5
71080704|NCT00136214|141667748|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in DLPFC. Comparison on MR spectroscopy of MI/Cr at time points 1 and 2||||0.4
71080705|NCT00136214|141667748|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in DLPFC. Comparison on MR spectroscopy of NAA/Crat time points 1 and 2||||0.9
71080706|NCT00136214|141667749|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Comparison between controls and IFN treated at time point 1 on change between scores for HVLT||||>0.05
71080707|NCT00136214|141667749|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Comparison between controls and IFN treated at time point 1 on change between scores for ROCF||||< 0.05
71080708|NCT00136214|141667749|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Comparison between controls and IFN treated at time point 2 on change between scores for HVLT||||>0.05
71080709|NCT00136214|141667749|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Comparison between controls and IFN treated at time point 2 on change between scores for ROCF||||>0.05
71080710|NCT04985942|141667750|SUPERIORITY||Least Squares Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED|95.0|-6.38|-3.44|||Mixed Effects Model for Repeated Measure|MMRM Analysis Based on Hypothetical Estimand Strategy||||-3.44|-6.38|<0.0001
71080711|NCT04985942|141667751|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.85|-0.48|||Mixed Effects Model for Repeated Measure|MMRM Analysis Based on Hypothetical Estimand Strategy||||-0.48|-0.85|<0.0001
71080712|NCT02849704|141667753|SUPERIORITY||||||<|0.001||||||a priori threshold for significance: \<0.05|t-test, 2 sided|||||||<0.001
71080713|NCT02849704|141667754|SUPERIORITY||||||>|0.05||||||a priori threshold for statistical significance \<0.05|t-test, 2 sided|||||||>0.05
71080714|NCT02849704|141667755|SUPERIORITY||||||<|0.01||||||a priori threshold for statistical significance \<0.05|t-test, 2 sided|||||||<0.01
71080715|NCT02849704|141667756|SUPERIORITY||||||>|0.05||||||a priori threshold for statistical significance \<0.05|t-test, 2 sided|||||||>0.05
71080716|NCT02849704|141667757|SUPERIORITY||||||<|0.05||||||a priori threshold for statistical significance \<0.05|t-test, 2 sided|||||||<0.05
71080717|NCT02849704|141667758|SUPERIORITY||||||>|0.05||||||a priori threshold for statistical significance \<0.05|t-test, 2 sided|||||||>0.05
71080718|NCT01128400|141667761|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||||||0.05
71080719|NCT01128400|141667762|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||||||0.05
71080720|NCT04336475|141667821|SUPERIORITY|||||||0.564||||||The threshold for statistical significance was p=0.05. p value stands for the comparison of final oral aperture measurements between two groups. (after 2 months' period)|ANOVA|Repeated Measures ANOVA||||||0.564
70854858|NCT00534313|141198171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.48|||||TWO_SIDED|95.0|4.82|56.15|||ANCOVA|||||56.15|4.82|
71080721|NCT03188523|141667825|SUPERIORITY||Posterior Mean Difference|-1.03|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8504 and placebo at least 0.5 log10 copies/mL was \>98%|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).||||
71080722|NCT03188523|141667825|SUPERIORITY||Posterior Mean Difference|-0.92|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8504 and placebo at least 0.5 log10 copies/mL was \>95%|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).||||
71080723|NCT03188523|141667841|OTHER||Posterior Probability (percentage)|99.0|||||||||||||Posterior Probability (percentage) of true geometric mean (GM) C168hr TFV-DP level in PBMCs ≥0.1 μM|PBMC TFV-DP C168hr values pooled, natural log transformed and analyzed based on a linear model containing a fixed effect for dose level. The posterior probability that the true GM of PBMC TFV-DP C168hr level was ≥0.1 μM was calculated for the dose level using flat priors under a normal likelihood assumption. An 80% posterior probability for a dose level that also exhibits acceptable safety and tolerability would satisfy the secondary PK hypothesis.||||
71080724|NCT03188523|141667841|OTHER||Posterior Probability (percentage)|99.0|||||||||||||Posterior Probability (percentage) of true geometric mean (GM) C168hr TFV-DP level in PBMCs ≥0.1 μM|PBMC TFV-DP C168hr values pooled, natural log transformed and analyzed based on a linear model containing a fixed effect for dose level. The posterior probability that the true GM of PBMC TFV-DP C168hr level was ≥0.1 μM was calculated for the dose level using flat priors under a normal likelihood assumption. An 80% posterior probability for a dose level that also exhibits acceptable safety and tolerability would satisfy the secondary PK hypothesis.||||
71080725|NCT02171429|141667853|SUPERIORITY||Difference in Remission Rates|7.2||||0.1729|TWO_SIDED|95.0|-3.83|16.12||The threshold for statistical significance was a p-value \<0.05.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|The null hypothesis (H0): the percentage of participants achieving remission at Week 10 was the same in both the placebo and etrolizumab arms. The alternative hypothesis (H1): the percentage of participants achieving remission at Week 10 was not the same in the placebo and etrolizumab arms.||16.12|-3.83|0.1729
71080726|NCT02171429|141667854|SUPERIORITY||Difference in Remission Rates|-6.8||||0.1458|TWO_SIDED|95.0|-16.26|2.73||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||2.73|-16.26|0.1458
71080727|NCT02171429|141667855|SUPERIORITY||Difference in Remission Rates|-5.0||||1|TWO_SIDED|95.0|-11.66|1.75||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 3 of the testing procedure; please refer to the statistical analysis plan for details.||1.75|-11.66|1
71080728|NCT02171429|141667856|SUPERIORITY||Difference in Response Rates|14.0||||0.1729|TWO_SIDED|95.0|-0.12|27.19||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 1 of the testing procedure; please refer to the statistical analysis plan for details.||27.19|-0.12|0.1729
71119419|NCT00642174|141744046|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.6|||<|0.0001||95.0|-31.18|-22.02||P-value for 4 Hour After Loading Dose (5 uM ADP). A priori threshold for statisitical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-22.02|-31.18|<0.0001
71119420|NCT00642174|141744046|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.3|||<|0.0001||95.0|-27.42|-19.17||P-value for 24 Hour After Loading Dose (5 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-19.17|-27.42|<0.0001
71119421|NCT00642174|141744046|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.7||||0.0001||95.0|-12.78|-4.58||P-value for 24 Hour After Last Maintenance Dose (5 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-4.58|-12.78|0.0001
71119422|NCT00642174|141744046|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.8779||95.0|-2.8|3.26||P-value for Baseline (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||3.26|-2.80|0.8779
71119423|NCT00642174|141744046|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-25.2|||<|0.0001||95.0|-32.43|-17.87||P-value for 1 Hour After Loading Dose (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-17.87|-32.43|<0.0001
71119424|NCT00642174|141744046|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-35.1|||<|0.0001||95.0|-40.32|-29.78||P-value for 4 Hour After Loading Dose (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-29.78|-40.32|<0.0001
71119425|NCT00642174|141744046|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-31.0|||<|0.0001||95.0|-36.32|-25.66||P-value for 24 Hour After Loading Dose (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-25.66|-36.32|<0.0001
71119426|NCT00642174|141744046|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.4|||<|0.0001||95.0|-17.19|-7.58||P-value for 24 Hour After Last Maintenance Dose (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-7.58|-17.19|<0.0001
71119427|NCT00642174|141744047|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9||||0.3692||95.0|-3.6|9.44||P-value for Baseline. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as assessed by VASP.||9.44|-3.60|0.3692
71119428|NCT00642174|141744047|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-36.2|||<|0.0001||95.0|-47.43|-24.98||P-value for 1 Hour After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as assessed by VASP.||-24.98|-47.43|<0.0001
70854859|NCT00534313|141198173|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.08||||||95.0|-4.79|8.96|||ANCOVA|ANCOVA model with treatment as factor and baseline value as covariate was used for the analysis.||||8.96|-4.79|
70854860|NCT00534313|141198173|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.01|||||TWO_SIDED|95.0|-4.94|8.95|||ANCOVA|ANCOVA model with treatment as factor and baseline value as covariate was used for the analysis.||||8.95|-4.94|
71119429|NCT00642174|141744047|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-53.0|||<|0.0001||95.0|-61.89|-44.02||P-value for 4 Hours After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as assessed by VASP.||-44.02|-61.89|<0.0001
71119430|NCT00642174|141744047|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-42.8|||<|0.0001||95.0|-50.03|-35.55||P-value for 24 Hours After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as assessed by VASP.||-35.55|-50.03|<0.0001
71119431|NCT00642174|141744047|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.9||||0.0012||95.0|-23.42|-6.37||P-value for 24 Hours After Last Maintenance Dose. A priori threshold for statistical significance was set to p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as assessed by VASP.||-6.37|-23.42|0.0012
71119432|NCT00642174|141744048|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.5238||95.0|-5.35|2.78||P-value for Baseline. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP).||2.78|-5.35|0.5238
71119433|NCT00642174|141744048|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.2|||<|0.0001||95.0|-21.15|-11.33||P-value for 1 Hour After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP).||-11.33|-21.15|<0.0001
71119434|NCT00642174|141744048|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.9|||<|0.0001||95.0|-29.67|-18.11||P-value for 4 Hours After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP).||-18.11|-29.67|<0.0001
71119435|NCT00642174|141744048|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.9|||<|0.0001||95.0|-24.97|-14.9||P-value for 24 Hours After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP).||-14.90|-24.97|<0.0001
71119436|NCT00642174|141744048|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6||||0.3725||95.0|-8.46|3.26||P-value for 24 Hours After Last Maintenance Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP).||3.26|-8.46|0.3725
71119437|NCT00896363|141744049|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.85|||||TWO_SIDED|90.0|-1.62|3.32|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of HAMD17|Comparison of placebo and GSK163090 1 mg on Day 14||3.32|-1.62|
71119438|NCT00896363|141744049|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33|||||TWO_SIDED|90.0|-2.12|2.78|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of HAMD17|Comparison of placebo and GSK163090 3 mg on Day 14||2.78|-2.12|
71119439|NCT00896363|141744049|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.57|||||TWO_SIDED|90.0|-2.01|5.14|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of HAMD17|Comparison of placebo and GSK163090 1 mg on Day 42||5.14|-2.01|
70854861|NCT00534313|141198173|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.75|||||TWO_SIDED|95.0|-6.08|7.58|||ANCOVA|ANCOVA model with treatment as factor and baseline value as covariate was used for the analysis.||||7.58|-6.08|
71119440|NCT00896363|141744049|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.66|||||TWO_SIDED|90.0|-1.81|5.13|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of HAMD17|Comparison of placebo and GSK163090 3 mg on Day 42||5.13|-1.81|
71119441|NCT00896363|141744050|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.31|||||TWO_SIDED|90.0|-0.93|1.56|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of BECH 6 scale|Comparison of placebo and GSK163090 1 mg on Day 14||1.56|-0.93|
71119442|NCT00896363|141744050|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.51|||||TWO_SIDED|90.0|-0.73|1.75|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of BECH 6 scale|Comparison of placebo and GSK163090 3 mg on Day 14||1.75|-0.73|
71119443|NCT00896363|141744050|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.66|||||TWO_SIDED|90.0|-1.1|2.42|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of BECH 6 scale|Comparison of placebo and GSK163090 1 mg on Day 42||2.42|-1.10|
71119444|NCT00896363|141744050|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77|||||TWO_SIDED|90.0|-0.93|2.48|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of BECH 6 scale|Comparison of placebo and GSK163090 3 mg on Day 42||2.48|-0.93|
71119445|NCT00896363|141744051|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.72|||||TWO_SIDED|90.0|-0.94|2.37|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of QIDS-SR scale|Comparison of placebo and GSK163090 1 mg on Day 14||2.37|-0.94|
71119446|NCT00896363|141744051|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44|||||TWO_SIDED|90.0|-2.1|1.21|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of QIDS-SR scale|Comparison of placebo and GSK163090 3 mg on Day 14||1.21|-2.10|
71119447|NCT00896363|141744051|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.84|||||TWO_SIDED|90.0|-1.22|2.9|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of QIDS-SR scale|Comparison of placebo and GSK163090 1 mg on Day 42||2.90|-1.22|
71119448|NCT00896363|141744051|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.81|||||TWO_SIDED|90.0|-1.22|2.85|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of QIDS-SR scale|Comparison of placebo and GSK163090 3 mg on Day 42||2.85|-1.22|
71119449|NCT01691885|141744107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.83|||<|0.001|TWO_SIDED|95.0|2.74|8.91|||ANCOVA|Analysis was performed using an ANCOVA model with covariates of treatment, baseline, period and subject as a random effect.||||8.91|2.74|<0.001
71119450|NCT03989427|141744117|EQUIVALENCE|The two treatment sequence could be called equivalent if the observed difference and its 95% CI are completely inside the interval of clinical equivalence. A significant result (p \< 0.05) means that the two treatments are equivalent, according the definition of equivalence as defined clinically.|Mean Difference (Net)|1.424||||0.022|TWO_SIDED|95.0|0.221|2.628||The threshold for statistical significance was p \<0.05|ANOVA|Three-way mixed ANOVA was done to determine the effect of Intervention on BPI scores .||"Null hypothesis is that the sequence of brushing first and flossing later has no effect on gingival inflammation.~No previous studies with Mean and SD were available. Hence, a pilot study was done. 30 participants were randomly assigned to Brush first and floss later (BF) group ; and Floss first brush later(FB) group. After 1 week there was cross-over. 80% power is required to detect mean difference in BPI scores."||2.628|0.221|0.022
71119451|NCT03989427|141744118|EQUIVALENCE|The two treatment sequence could be called equivalent if the observed difference and its 95% CI are completely inside the interval of clinical equivalence. A significant result (p \< 0.05) means that the two treatments are equivalent, according the definition of equivalence as defined clinically.|Mean Difference (Net)|-0.058||||0.971|TWO_SIDED|95.0|-3.335|3.219|||ANOVA|Three-way mixed ANOVA was done to determine the effect of Intervention on RMNPI index scores||"Null hypothesis:~The sequence of brushing and flossing has no effect on plaque scores~There were no previous studies with Mean and SD to calculate sample. So a pilot study was conducted. 30 participants were randomly assigned in 1:1 fashion to Brush-floss (GroupA) and Floss brush group (group B). Then after 1 week there was cross-over among the groups.2 groups would have at least 80% power to detect the mean difference in BPI scores."||3.219|-3.335|0.971
71119452|NCT03344549|141744141|SUPERIORITY||Mean Difference (Final Values)|-1.76|STANDARD_DEVIATION|0.8||0.37|TWO_SIDED|95.0||||The threshoid for statistical significance was p \<0.05|t-test, 2 sided|||U Mann Whitney was used for inter-group comparison||||0.37
71119453|NCT03344549|141744142|SUPERIORITY||Mean Difference (Final Values)|-1.76|STANDARD_DEVIATION|0.8||0.46|TWO_SIDED|95.0||||The threshold for statistical significance was p\<0.05|t-test, 2 sided|U Mann Whitney was used for inter-group comparison||||||0.46
71119454|NCT03344549|141744143|SUPERIORITY|||||||0.16|||||||Chi-squared|||||||0.16
71119455|NCT00108303|141744169|SUPERIORITY_OR_OTHER||Log (odd ratio)|5.2|||||TWO_SIDED|||||||||||||
71119456|NCT00108303|141744169|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||This parameter was estimated by simulating 1000 samples with random genotypes and finding no value equal to or greater than 5.2.|Simulation|||||||<0.001
71119457|NCT00108303|141744170|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Firsher's transform r to Z|||The coefficient of segregation versus no segregation of the P50 sensory gating percent in families with schizophrenia.||||0.001
71119458|NCT02075047|141744178|SUPERIORITY||Difference in least square (LS) mean|-4.23|STANDARD_ERROR_OF_MEAN|1.47||0.005|TWO_SIDED|95.0|-7.14|-1.32|||Mixed Models Analysis|||Change at Week 4: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||-1.32|-7.14|0.005
71119459|NCT02075047|141744179|SUPERIORITY||Difference in LS mean|-0.45|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-0.69|-0.2|||Mixed Models Analysis|||Change at Week 1: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||-0.20|-0.69|<0.001
70854862|NCT00534313|141198177|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.15|||||TWO_SIDED|95.0|1.97|12.33|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as factor and baseline value as covariate was used for the analysis.||||12.33|1.97|
70854863|NCT00534313|141198177|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.12|||||TWO_SIDED|95.0|3.83|14.41|||ANCOVA|ANCOVA model with treatment as factor and baseline value as covariate was used for the analysis||||14.41|3.83|
70854864|NCT00534313|141198177|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.17|||||TWO_SIDED|95.0|1.01|11.32|||ANCOVA|ANCOVA model with treatment as factor and baseline value as covariate was used for the analysis.||||11.32|1.01|
70854865|NCT00534313|141198178|SUPERIORITY_OR_OTHER||Difference|16.0|||||TWO_SIDED|95.0|-2.5|34.5|||Cochran-Mantel-Haenszel||Difference and 95% CI was based on CMH with stratification of baseline BSA affected by psoriasis.|||34.5|-2.5|
70854866|NCT00534313|141198178|SUPERIORITY_OR_OTHER||Difference|26.1||||||95.0|6.8|45.5|||Cochran-Mantel-Haenszel||Difference and 95% CI was based on CMH with stratification of baseline BSA affected by psoriasis.|||45.5|6.8|
70854867|NCT00534313|141198178|SUPERIORITY_OR_OTHER||Difference|16.6||||||95.0|-1.8|34.9|||Cochran-Mantel-Haenszel||Difference and 95% CI was based on CMH with stratification of baseline BSA affected by psoriasis.|||34.9|-1.8|
70854868|NCT01947855|141198194|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-104.87|STANDARD_ERROR_OF_MEAN|19.88|<|0.0001|TWO_SIDED|95.0|-144.77|-64.97|||ANCOVA|Model includes treatment, number of previous antidiabetic medication, baseline renal function, baseline HbA1c and baseline AUC1-4h for plasma glucose.||Difference calculated as empa 25 mg minus placebo. The analyses will be performed sequentially compared with placebo from high dose of empagliflozin and the full significance level (5%) will be maintained by the hierarchical procedure.||-64.97|-144.77|<0.0001
70854869|NCT01947855|141198194|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-85.49|STANDARD_ERROR_OF_MEAN|20.18|<|0.0001|TWO_SIDED|95.0|-126.01|-44.97|||ANCOVA|Model includes treatment, number of previous antidiabetic medication, baseline renal function, baseline HbA1c and baseline AUC1-4h for plasma glucose.||Difference calculated as empa 10 mg minus placebo. The analyses will be performed sequentially compared with placebo from high dose of empagliflozin and the full significance level (5%) will be maintained by the hierarchical procedure.||-44.97|-126.01|<0.0001
70854870|NCT03011892|141198206|SUPERIORITY||Difference in Least Square (LS) Mean|-59.66|||<|0.0001|TWO_SIDED|95.0|-77.85|-41.47|||MMRM|||||-41.47|-77.85|< 0.0001
70854871|NCT03011892|141198207|SUPERIORITY||Difference in LS Mean|-33.01||||0.0004|TWO_SIDED|95.0|-51.27|-14.76|||MMRM|||DB: Vehicle BID, Ruxolitinib 0.15% QD||-14.76|-51.27|0.0004
70854872|NCT03011892|141198207|SUPERIORITY||Difference in LS Mean|-40.9|||<|0.0001|TWO_SIDED|95.0|-59.23|-22.57|||MMRM|||||-22.57|-59.23|< 0.0001
70854873|NCT03011892|141198207|SUPERIORITY||Difference in LS Mean|-54.82|||<|0.0001|TWO_SIDED|95.0|-72.93|-36.7|||MMRM|||||-36.70|-72.93|< 0.0001
71119460|NCT02075047|141744179|SUPERIORITY||Difference in LS mean|-0.22|STANDARD_ERROR_OF_MEAN|0.16||0.174|TWO_SIDED|95.0|-0.53|0.1|||Mixed Models Analysis|||Change at Week 2: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.10|-0.53|0.174
71119461|NCT02075047|141744179|SUPERIORITY||Difference in LS mean|-0.38|STANDARD_ERROR_OF_MEAN|0.17||0.024|TWO_SIDED|95.0|-0.71|-0.05|||Mixed Models Analysis|||Change at Week 3: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||-0.05|-0.71|0.024
71119462|NCT02075047|141744179|SUPERIORITY||Difference in LS mean|-0.28|STANDARD_ERROR_OF_MEAN|0.19||0.138|TWO_SIDED|95.0|-0.64|0.09|||Mixed Models Analysis|||Change at Week 4: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.09|-0.64|0.138
71119463|NCT02075047|141744180|SUPERIORITY||Difference in LS mean|-5.85|STANDARD_ERROR_OF_MEAN|1.17|<|0.001|TWO_SIDED|95.0|-8.16|-3.54|||Mixed Models Analysis|||Change at Week 1: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||-3.54|-8.16|<0.001
71119464|NCT02075047|141744180|SUPERIORITY||Difference in LS mean|-4.17|STANDARD_ERROR_OF_MEAN|1.3||0.002|TWO_SIDED|95.0|-6.74|-1.59|||Mixed Models Analysis|||Change at Week 2: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||-1.59|-6.74|0.002
71119465|NCT02075047|141744180|SUPERIORITY||Difference in LS mean|-5.63|STANDARD_ERROR_OF_MEAN|1.31|<|0.001|TWO_SIDED|95.0|-8.21|-3.04|||Mixed Models Analysis|||Change at Week 3: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||-3.04|-8.21|<0.001
71119466|NCT02075047|141744181|SUPERIORITY||Difference in LS mean|-0.52|STANDARD_ERROR_OF_MEAN|0.13||0.001|TWO_SIDED|95.0|-0.78|-0.26|||Mixed Models Analysis|||Change at Week 1: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects along with participant as a random effect.||-0.26|-0.78|0.001
71119467|NCT02075047|141744181|SUPERIORITY||Difference in LS mean|-0.15|STANDARD_ERROR_OF_MEAN|0.15||0.349|TWO_SIDED|95.0|-0.45|0.16|||Mixed Models Analysis|||Change at Week 2: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects along with participant as a random effect.||0.16|-0.45|0.349
71119468|NCT02075047|141744181|SUPERIORITY||Difference in LS mean|-0.26|STANDARD_ERROR_OF_MEAN|0.16||0.103|TWO_SIDED|95.0|-0.57|0.05|||Mixed Models Analysis|||Change at Week 3: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects along with participant as a random effect.||0.05|-0.57|0.103
71119469|NCT02075047|141744181|SUPERIORITY||Difference in LS mean|-0.35|STANDARD_ERROR_OF_MEAN|0.17||0.044|TWO_SIDED|95.0|-0.68|-0.01|||Mixed Models Analysis|||Change at Week 4: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects along with participant as a random effect.||-0.01|-0.68|0.044
70854874|NCT03011892|141198208|SUPERIORITY||Difference in LS Mean|14.63||||0.1127|TWO_SIDED|95.0|-3.47|32.73|||MMRM|||Triamcinolone 0.1% BID/Vehicle Cream BID, DB: Ruxolitinib 0.15% QD||32.73|-3.47|0.1127
70854875|NCT03011892|141198208|SUPERIORITY||Difference in LS Mean|6.74||||0.4659|TWO_SIDED|95.0|-11.44|24.92|||MMRM|||Triamcinolone 0.1% BID/Vehicle Cream BID, DB: Ruxolitinib 0.5% QD||24.92|-11.44|0.4659
70854876|NCT03011892|141198208|SUPERIORITY||Difference in LS Mean|-7.18||||0.432|TWO_SIDED|95.0|-25.13|10.77|||MMRM|||Triamcinolone 0.1% BID/Vehicle Cream BID, DB: Ruxolitinib 1.5% QD||10.77|-25.13|0.4320
70854877|NCT03011892|141198208|SUPERIORITY||Difference in LS Mean|-12.02||||0.1903|TWO_SIDED|95.0|-30.05|6.0|||MMRM|||||6.00|-30.05|0.1903
70943593|NCT01040403|141387590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.028|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.097|0.041|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.041|-0.097|
70854878|NCT03011892|141198209|SUPERIORITY||Difference in LS Mean|-25.12||||0.0009|TWO_SIDED|95.0|-39.84|-10.41|||MMRM|||Week 2||-10.41|-39.84|0.0009
70854879|NCT03011892|141198209|SUPERIORITY||Difference in LS Mean|-47.85|||<|0.0001|TWO_SIDED|95.0|-62.64|-33.06|||MMRM|||Week 2||-33.06|-62.64|< 0.0001
70854880|NCT03011892|141198209|SUPERIORITY||Difference in LS Mean|-41.04|||<|0.0001|TWO_SIDED|95.0|-56.0|-26.08|||MMRM|||Week 2||-26.08|-56.00|< 0.0001
70854881|NCT03011892|141198209|SUPERIORITY||Difference in LS Mean|-45.05|||<|0.0001|TWO_SIDED|95.0|-59.69|-30.4|||MMRM|||Week 2||-30.40|-59.69|< 0.0001
70943594|NCT01040403|141387590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.089|0.048|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.048|-0.089|
71119470|NCT02075047|141744195|SUPERIORITY||Difference in LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.05||0.05|TWO_SIDED|95.0|0.0|0.2|||Mixed Models Analysis|||Change at Week 1: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.20|0.00|0.050
71119471|NCT02075047|141744195|SUPERIORITY||Difference in LS mean|0.11|STANDARD_ERROR_OF_MEAN|0.07||0.124|TWO_SIDED|95.0|-0.03|0.25|||Mixed Models Analysis|||Change at Week 2: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.25|-0.03|0.124
71119472|NCT02075047|141744195|SUPERIORITY||Difference in LS mean|0.11|STANDARD_ERROR_OF_MEAN|0.06||0.084|TWO_SIDED|95.0|-0.01|0.23|||Mixed Models Analysis|||Change at Week 3: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.23|-0.01|0.084
71119473|NCT02075047|141744195|SUPERIORITY||Difference in LS mean|0.09|STANDARD_ERROR_OF_MEAN|0.05||0.104|TWO_SIDED|95.0|-0.02|0.2|||Mixed Models Analysis|||Change at Week 4: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.20|-0.02|0.104
71119474|NCT02075047|141744196|SUPERIORITY||Difference in LS mean|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.169|TWO_SIDED|95.0|-0.06|0.01|||Mixed Models Analysis|||Change at Week 1: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.01|-0.06|0.169
71119475|NCT02075047|141744196|SUPERIORITY||Difference in LS mean|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.893|TWO_SIDED|95.0|-0.1|0.08|||Mixed Models Analysis|||Change at Week 2: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.08|-0.10|0.893
71119476|NCT02075047|141744196|SUPERIORITY||Difference in LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.915|TWO_SIDED|95.0|-0.04|0.04|||Mixed Models Analysis|||Change at Week 3: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.04|-0.04|0.915
71119477|NCT02075047|141744196|SUPERIORITY||Difference in LS mean|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.289|TWO_SIDED|95.0|-0.01|0.04|||Mixed Models Analysis|||Change at Week 4: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.04|-0.01|0.289
71119478|NCT02075047|141744197|SUPERIORITY||Difference in LS mean|0.03|STANDARD_ERROR_OF_MEAN|0.02||0.145|TWO_SIDED|95.0|-0.01|0.06|||Mixed Models Analysis|||Change at Week 1: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.06|-0.01|0.145
71119479|NCT02075047|141744197|SUPERIORITY||Difference in LS mean|0.03|STANDARD_ERROR_OF_MEAN|0.02||0.148|TWO_SIDED|95.0|-0.01|0.07|||Mixed Models Analysis|||Change at Week 2: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.07|-0.01|0.148
71119480|NCT02075047|141744197|SUPERIORITY||Difference in LS mean|0.07|STANDARD_ERROR_OF_MEAN|0.04||0.082|TWO_SIDED|95.0|-0.01|0.15|||Mixed Models Analysis|||Change at Week 3: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.15|-0.01|0.082
71119481|NCT02075047|141744197|SUPERIORITY||Difference in LS mean|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.07|TWO_SIDED|95.0|0.0|0.09|||Mixed Models Analysis|||Change at Week 4: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.09|-0.00|0.070
71119482|NCT03552536|141744200|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. Least squares (LS) mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).|Posterior Mean Difference|-0.6|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8583 and placebo at least 0.5 log10 copies/mL was 64%.|||||
71119483|NCT03061721|141744233|SUPERIORITY|||||||0.0002|||||||ANCOVA|||||||0.0002
71119484|NCT03061721|141744233|SUPERIORITY|||||||0.0001|||||||ANCOVA|||||||0.0001
71119485|NCT03061721|141744233|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71119486|NCT03061721|141744234|SUPERIORITY|||||||0.5681|||||||ANCOVA|||||||0.5681
71119487|NCT03061721|141744234|SUPERIORITY|||||||0.4487|||||||ANCOVA|||||||0.4487
71119488|NCT03061721|141744234|SUPERIORITY|||||||0.0021|||||||ANCOVA|||||||0.0021
71119489|NCT03061721|141744235|SUPERIORITY|||||||0.007|||||||Chi-squared|||||||0.0070
71119490|NCT03061721|141744235|SUPERIORITY|||||||0.0031|||||||Chi-squared|||||||0.0031
71119491|NCT03061721|141744235|SUPERIORITY|||||||0.0001|||||||Chi-squared|||||||0.0001
71119492|NCT03061721|141744236|SUPERIORITY|||||||0.2241|||||||ANCOVA|||||||0.2241
71119493|NCT03061721|141744236|SUPERIORITY|||||||0.0304|||||||ANCOVA|||||||0.0304
70854882|NCT03011892|141198209|SUPERIORITY||Difference in LS Mean|9.99||||0.1806|TWO_SIDED|95.0|-4.66|24.63|||MMRM|||Week 2||24.63|-4.66|0.1806
71119494|NCT03061721|141744236|SUPERIORITY|||||||0.0595|||||||ANCOVA|||||||0.0595
71119495|NCT03061721|141744237|SUPERIORITY|||||||0.0449|||||||ANCOVA|||||||0.0449
71119496|NCT03061721|141744237|SUPERIORITY|||||||0.0053|||||||ANCOVA|||||||0.0053
70854883|NCT03011892|141198209|SUPERIORITY||Difference in LS Mean|-5.93||||0.4333|TWO_SIDED|95.0|-20.82|8.95|||MMRM|||Week 2||8.95|-20.82|0.4333
70854884|NCT03011892|141198209|SUPERIORITY||Difference in LS Mean|-9.94||||0.1805|TWO_SIDED|95.0|-24.51|4.63|||MMRM|||Week 2||4.63|-24.51|0.1805
70854885|NCT03011892|141198209|SUPERIORITY||Difference in LS Mean|-12.74||||0.0895|TWO_SIDED|95.0|-27.45|1.98|||MMRM|||Week 2||1.98|-27.45|0.0895
70854886|NCT03011892|141198209|SUPERIORITY||Difference in LS Mean|-28.38||||0.0042|TWO_SIDED|95.0|-47.74|-9.02|||MMRM|||Week 8||-9.02|-47.74|0.0042
71119497|NCT03061721|141744237|SUPERIORITY|||||||0.0036|||||||ANCOVA|||||||0.0036
71119498|NCT03061721|141744238|SUPERIORITY|||||||0.0045|||||||ANCOVA|||||||0.0045
71119499|NCT03061721|141744238|SUPERIORITY|||||||0.0026|||||||ANCOVA|||||||0.0026
71119500|NCT03061721|141744238|SUPERIORITY|||||||0.0004|||||||ANCOVA|||||||0.0004
71119501|NCT03061721|141744247|SUPERIORITY|||||||0.2387|||||||ANCOVA|||||||0.2387
71119502|NCT03061721|141744247|SUPERIORITY|||||||0.1496|||||||ANCOVA|||||||0.1496
71119503|NCT03061721|141744247|SUPERIORITY|||||||0.0445|||||||ANCOVA|||||||0.0445
71119504|NCT00457821|141744333|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Within-dose group and between-dose group analyses were performed, using a linear mixed effect model with baseline, dose, and period as fixed effects and subject as a random effect.||||<0.05
71119505|NCT00457821|141744334|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Within-dose group and between-dose group analyses were performed, using a linear mixed effect model with baseline, dose, and period as fixed effects and subject as a random effect.||||<0.05
71119506|NCT00457821|141744336|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Within-dose group and between-dose group analyses were performed, using a linear mixed effect model with baseline, dose, and period as fixed effects and subject as a random effect.||||<0.05
71119507|NCT02139878|141744341|SUPERIORITY_OR_OTHER||||||=|0.088|||||||ANCOVA|||||||=0.088
71119508|NCT02139878|141744342|SUPERIORITY_OR_OTHER||||||=|0.98|||||||ANCOVA|||||||=0.980
71119509|NCT01632241|141744353|SUPERIORITY||Odds Ratio (OR)|1.4||||0.1068|TWO_SIDED|95.0|0.93|2.11|||Regression, Logistic|||||2.11|0.93|0.1068
71119510|NCT01632241|141744362|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0937|TWO_SIDED|95.0|0.94|2.15||Nominal p-value due to step-down sequential testing procedure.|Regression, Logistic|||||2.15|0.94|0.0937
71119511|NCT01632241|141744364|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.2264|TWO_SIDED|95.0|0.51|1.17||Nominal p-value due to step-down sequential testing procedure.|Cox proportional hazards model|||||1.17|0.51|0.2264
71119512|NCT01632241|141744366|SUPERIORITY||Odds Ratio (OR)|1.3||||0.4996|TWO_SIDED|95.0|0.61|2.8||Nominal p-value due to step-down sequential testing procedure.|Regression, Logistic|||||2.80|0.61|0.4996
71119513|NCT05032690|141744405|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|99.17|||||TWO_SIDED|90.0|93.72|104.93|||Mixed Models Analysis|||"For comparison of Bosutinib 4\*25 mg Capsule Fed vs. Bosutinib 1\*100 mg Capsule Fed, the model is a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.~The reference treatment of Bosutinib 4\*25 mg Capsule Fed is Bosutinib 1\*100 mg Capsule Fed."||104.93|93.72|
71119514|NCT05032690|141744405|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|135.9|||||TWO_SIDED|90.0|109.28|169.01|||Mixed Models Analysis|||"For comparison of Bosutinib 1\*100 mg Capsule Fed vs. Bosutinib 1\*100 mg Capsule Fasted, the model is a mixed effect model with sequence and treatment as fixed effects and participant within sequence as a random effect.~The reference treatment of Bosutinib 1\*100 mg Capsule Fed is Bosutinib 1\*100 mg Capsule Fasted."||169.01|109.28|
71119515|NCT05032690|141744406|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|93.77|||||TWO_SIDED|90.0|90.08|97.61|||Mixed Models Analysis|||"For comparison of Bosutinib 4\*25 mg Capsule Fed vs. Bosutinib 1\*100 mg Capsule Fed, the model is a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.~The reference treatment of Bosutinib 4\*25 mg Capsule Fed is Bosutinib 1\*100 mg Capsule Fed."||97.61|90.08|
71119516|NCT05032690|141744406|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|162.54|||||TWO_SIDED|90.0|130.25|202.84|||Mixed Models Analysis|||"For comparison of Bosutinib 1\*100 mg Capsule Fed vs. Bosutinib 1\*100 mg Capsule Fasted, the model is a mixed effect model with sequence and treatment as fixed effects and participant within sequence as a random effect.~The reference treatment of Bosutinib 1\*100 mg Capsule Fed is Bosutinib 1\*100 mg Capsule Fasted"||202.84|130.25|
71119517|NCT05032690|141744407|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|98.21|||||TWO_SIDED|90.0|93.83|102.8|||Mixed Models Analysis|||"For comparison of Bosutinib 4\*25 mg Capsule Fed vs. Bosutinib 1\*100 mg Capsule Fed, the model is a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.~The reference treatment of Bosutinib 4\*25 mg Capsule Fed is Bosutinib 1\*100 mg Capsule Fed."||102.80|93.83|
71119518|NCT05032690|141744407|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|146.7|||||TWO_SIDED|90.0|117.88|182.58|||Mixed Models Analysis|||"For comparison of Bosutinib 1\*100 mg Capsule Fed vs. Bosutinib 1\*100 mg Capsule Fasted, the model is a mixed effect model with sequence and treatment as fixed effects and participant within sequence as a random effect.~The reference treatment of Bosutinib 1\*100 mg Capsule Fed is Bosutinib 1\*100 mg Capsule Fasted."||182.58|117.88|
71119519|NCT00737568|141744415|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||The p-value for the two-sided Cochran-Mantel-Haenszel test was controlled for strata (HBeAg status and ALT level).|Cochran-Mantel-Haenszel|||The null hypothesis is that there is no difference between the FTC/TDF and TDF treatment groups. The alternative hypothesis is that there is a difference between the FTC/TDF and TDF treatment groups. These hypotheses were evaluated using a Cochran-Mantel-Haenszel (CMH) test, controlling for randomization strata, with the missing = failure method in which participants with missing data were considered to have failed to achieve the endpoint.||||0.43
71119520|NCT00855933|141744428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.066||0.126|TWO_SIDED|95.0|-0.03|0.24||a priori threshold for statistical significance = 0.05|ANCOVA||2-sided with the significance level set at 5%|||0.24|-0.03|0.126
71119521|NCT01960998|141744429|SUPERIORITY|||||||0.22||||||P value not adjusted for multiple comparisons|Log Rank||||Data were not collected beyond the 12-month follow up, at which point fewer than 50% of participants in both groups had achieved continence. Thus, their time to continence could not be determined and the medians could not be calculated.|||0.22
70854887|NCT03011892|141198209|SUPERIORITY||Difference in LS Mean|-36.52||||0.0003|TWO_SIDED|95.0|-56.03|-17.01|||MMRM|||Week 8||-17.01|-56.03|0.0003
70854888|NCT03011892|141198209|SUPERIORITY||Difference in LS Mean|-45.19|||<|0.0001|TWO_SIDED|95.0|||||MMRM|||Week 8||||< 0.0001
70854889|NCT03011892|141198209|SUPERIORITY||Difference in LS Mean|-57.15|||<|0.0001|TWO_SIDED|95.0|-76.53|-37.77|||MMRM|||Week 8||-37.77|-76.53|< 0.0001
70854890|NCT03011892|141198209|SUPERIORITY||Difference in LS Mean|7.78||||0.4243|TWO_SIDED|95.0|-11.37|26.93|||MMRM|||Week 8||26.93|-11.37|0.4243
70854891|NCT03011892|141198209|SUPERIORITY||Difference in LS Mean|-0.35||||0.9715|TWO_SIDED|95.0|-19.65|18.95|||MMRM|||Week 8||18.95|-19.65|0.9715
70943595|NCT01040403|141387590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|0.106|0.242|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.242|0.106|
70854892|NCT03011892|141198209|SUPERIORITY||Difference in LS Mean|-9.03||||0.3507|TWO_SIDED|95.0|-28.05|9.99|||MMRM|||Week 8||9.99|-28.05|0.3507
70854893|NCT03011892|141198209|SUPERIORITY||Difference in LS Mean|-20.98||||0.032|TWO_SIDED|95.0|-40.15|-1.82|||MMRM|||Week 8||-1.82|-40.15|0.0320
70943596|NCT01040403|141387590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|0.113|0.25|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.250|0.113|
71119522|NCT01960998|141744430|SUPERIORITY|||||||0.7||||||P values were not corrected for multiple testing|ANCOVA|Baseline score was included as a covariate in analysis.|||Mean values for the telehealth and no telehealth groups on the ICIQ-SF are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean ICIQ-SF score in the no telehealth group at 6 months was 7.0 (standard deviation 4.4) and in the telehealth group was 7.1 (SD 4.3). Analysis of covariance (ANCOVA) was performed with each of the 10 imputations, adjusting for baseline ICIQ-SF score, and p values were combined using the Rubin-Licht method.|||0.70
71119523|NCT01960998|141744431|SUPERIORITY|||||||0.7||||||P values were not adjusted for multiple comparisons.|ANCOVA||||Mean values for the telehealth and no telehealth groups on the EPIC-UI are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean EPIC-UI score in the no telehealth group at 6 months was 63.5 (standard deviation 24.1) and in the telehealth group was 63.9 (SD 22.1). Analysis of covariance (ANCOVA) was performed with each of the 10 imputations, adjusting for baseline EPIC-UI score, and p values were combined using the Rubin-Licht method.|||0.70
71119524|NCT01960998|141744432|SUPERIORITY|||||||0.46||||||P values not adjusted for multiple comparisons.|t-test, 2 sided||||Mean values for the telehealth and no telehealth groups on the IIQ are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean IIQ score in the no telehealth group at 6 months was 22.3 (standard deviation 24.1) and in the telehealth group was 19.4 (SD 22.4). Two-sample t-tests were performed with each of the 10 imputations, and p values were combined using the Rubin-Licht method.|||0.46
71119525|NCT01960998|141744433|SUPERIORITY|||||||0.63||||||P values were not corrected for multiple comparisons|Chi-squared, Corrected||||Frequencies for the telehealth and no telehealth groups on the Quality of Life question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 31.4% (Delighted/Pleased), 22.8% (Mostly Satisfied), 19.4% (Mixed), 12.0% (Mostly Dissatisfied), and 14.4% (Unhappy/Terrible) and in the telehealth group were 20.8%, 26.3%, 26.3%, 12.6%, and 14.0%, respectively. Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 5 levels of the IPSS Quality of Life question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.|||0.63
71119526|NCT01960998|141744434|SUPERIORITY|||||||0.04||||||P values were not corrected for multiple comparisons|Chi-squared, Corrected||||Frequencies for the telehealth and no telehealth groups on the Patient Satisfaction question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 51.0% (Completely Satisfied), 40.2% (Somewhat Satisfied), and 8.7% (Not at All Satisfied) and in the telehealth group were 34.8%, 59.9%, and 5.3%, respectively (frequencies to not add to exactly 100% due to rounding). Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 3 levels of the Patient Satisfaction question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.|||0.04
71119527|NCT01960998|141744435|SUPERIORITY|||||||0.67||||||P values not adjusted for multiple comparisons|t-test, 2 sided||||Mean values for the telehealth and no telehealth groups on the Estimated Percent Improvement (EPI) are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean EPI score in the no telehealth group at 6 months was 65.1 (standard deviation 34.5) and in the telehealth group was 69.6 (SD 29.6). Two-sample t-tests were performed with each of the 10 imputations, and p values were combined using the Rubin-Licht method.|||0.67
71119528|NCT01960998|141744436|SUPERIORITY|||||||0.65|||||||Chi-squared, Corrected||||Frequencies for the telehealth and no telehealth groups on the Global Perception of Improvement (GPI) question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 46.3% (Much Better), 30.7% (Better), 16.7% (About the Same), 2.3% (Worse), and 3.9% (Much Worse) and in the telehealth group were 38.3%, 41.1%, 15.3%, 2.9%, and 2.5%, respectively (frequencies to not add to exactly 100% due to rounding). Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 5 levels of the Global Perception of Improvement question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.|||0.65
70854894|NCT02282293|141198216|OTHER||Risk Ratio (RR)|1.96||||0.5|TWO_SIDED|95.0|0.5|7.61||Calculated p-value|Chi-squared|||||7.61|0.50|0.50
70854895|NCT02282293|141198218|OTHER||Risk Ratio (RR)|1.96||||0.5|TWO_SIDED|95.0|0.5|7.61|||Chi-squared|||||7.61|0.50|0.50
70854896|NCT02282293|141198220|OTHER||Risk Ratio (RR)|0.45||||0.19|TWO_SIDED|95.0|0.13|1.48||Calculated p-value|GEE|||||1.48|0.13|0.19
70854897|NCT02282293|141198221|OTHER||Risk Ratio (RR)|1.33||||0.35|TWO_SIDED|95.0|0.72|2.45|||Chi-squared|||||2.45|0.72|0.35
71119529|NCT01960998|141744437|SUPERIORITY|||||||0.37||||||P values were not corrected for multiple comparisons|Chi-squared, Corrected||||"Frequencies for the telehealth and no telehealth groups on the How Disturbing is the Urine Leakage? question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 43.5% (Not at All), 44.4% (Somewhat), and 12.1% (Extremely) and in the telehealth group were 38.9%, 53.2%, and 7.9% respectively. Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 3 levels of the How Disturbing is the Urine Leakage? question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method."|||0.37
71119530|NCT01960998|141744438|SUPERIORITY|||||||0.63||||||P values were not adjusted for multiple comparisons|Chi-squared, Corrected||||Frequencies for the telehealth and no telehealth groups on the Activity Restriction question relative to the expected frequencies question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 51.0% (Not at all), 36.5% (Some of the time), 7.2% (Most of the time), and 5.3% (All of the time) and in the telehealth group were 56.5%, 33.5%, 4.2%, and 5.8% respectively (frequencies to not add to exactly 100% due to rounding). Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 4 levels of the Activity Restriction question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.|||0.63
70854898|NCT03381729|141198223|SUPERIORITY||Difference in Percent|-6.0|||>|0.9999|TWO_SIDED|95.0|-21.8|22.8|||Fisher Exact|||Difference in the percentage of participants who achieved the ability to stand alone.|Data for the current study were compared to historical control data (Finkel et al 2014 - PubMed 25080519) where 7 (13.7%) participants achieved the ability to stand alone and 44 (86.3%) participants did not achieve the ability to stand alone.|22.8|-21.8|>0.9999
70854899|NCT03381729|141198224|SUPERIORITY||Difference Between Least Squares Mean|5.5||||0.0027|TWO_SIDED|95.0|1.9|9.0|||Mixed-Model Repeat Measure||||Data for the current study were compared to historical control data (Finkel et al 2014 - PubMed 25080519) where the least squares mean (95% confidence interval) of the change from baseline in HFMSE scores at 12 months was 0.5 (-2.2 to 3.2).|9.0|1.9|0.0027
70854900|NCT03381729|141198226|SUPERIORITY||Percentage Difference|-2.1|||>|0.9999|TWO_SIDED|95.0|-17.2|27.0|||Fisher Exact|||Difference in the percentage of participants who achieved the ability to walk alone.|Data for the current study were compared to historical control data (Finkel et al 2014 PubMed 25080519) where 5 (9.8%) participants achieved the ability to walk alone and 46 (90.2%) participants did not achieve the ability to walk alone.|27.0|-17.2|>0.9999
70854901|NCT03758755|141198228|EQUIVALENCE|The a priori threshold for statistical significance was set at 0.05.||||||0.0219|||||||t-test, 1 sided|||Null hypothesis: there is no difference between groups in IKDC score at 12 weeks post-op.||||0.0219
70854902|NCT03758755|141198229|EQUIVALENCE|The a priori threshold for statistical significance was set at 0.05.||||||0.008|||||||t-test, 1 sided|||Null hypothesis: there is no difference between groups in VAS score at 12 weeks post-op.||||0.008
70943597|NCT01040403|141387590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|0.135|0.272|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.272|0.135|
71119531|NCT01960998|141744439|SUPERIORITY|||||||0.71||||||P values not adjusted for multiple comparisons|Chi-squared, Corrected||||Frequencies for the telehealth and no telehealth groups on the Return to Work question relative to the expected frequencies question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 52.3% (Yes), 5.0% (No, not yet recovered from surgery), 1.9% (No, other reason), and 40.7% (Retired or disabled) and in the telehealth group were 62.3%, 3.5%, 0.8%, and 33.5% respectively (frequencies to not add to exactly 100% due to rounding). Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 4 levels of the Return to Work question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.|||0.71
70854903|NCT03758755|141198230|EQUIVALENCE|The a priori threshold for statistical significance was set at 0.05.||||||0.011|||||||t-test, 1 sided|||This analysis compares the change over time in quadriceps tendon strength between the BFR Therapy group and the No BFR Group. Underlying data was collected on a biweekly basis as the percent difference of the operated knee compared to the contralateral side. This statistical test utilized the null hypothesis that there would be no difference between groups in the change in quadriceps tendon strength over time.||||0.011
70854904|NCT03758755|141198231|EQUIVALENCE|The a priori threshold for statistical significance was set at 0.05.||||||0.223|||||||t-test, 1 sided|||This analysis compares the change over time in thigh circumference between the BFR Therapy group and the No BFR Group. Underlying data was collected on a biweekly basis as the percent difference of the operated knee compared to the contralateral side. This statistical test utilized the null hypothesis that there would be no difference between groups in the change in thigh circumference over time.||||0.223
70854905|NCT03758755|141198232|EQUIVALENCE|The a priori threshold for statistical significance was set at 0.05.||||||0.242|||||||t-test, 1 sided|||This analysis compares the change over time in degrees of knee flexion between the BFR Therapy group and the No BFR Group from 2 weeks post-op to 12 weeks post-op. Underlying data was collected on a biweekly basis. This statistical test utilized the null hypothesis that there would be no difference between groups in the change in degrees of knee flexion over time.||||0.242
70943598|NCT01040403|141387590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.061|0.076|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.076|-0.061|
70943599|NCT01040403|141387590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.038|0.098|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.098|-0.038|
71119532|NCT01960998|141744440|SUPERIORITY|||||||0.41||||||P values not corrected for multiple comparisons|Chi-squared, Corrected||||Frequencies for the telehealth and no telehealth groups on the Resumption of Normal Activities question relative to the expected frequencies question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 7.4% (None), 29.8% (Some), 62.8% (All) and in the telehealth group were 4.9%, 23.0%, and 72.2% respectively (frequencies to not add to exactly 100% due to rounding). Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 3 levels of the Resumption of Normal Activities question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.|||0.41
71119533|NCT00759356|141744441|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|Mean ratio|109.8||||||90.0|95.3|126.5|||ANOVA|||||126.5|95.3|
71119534|NCT00759356|141744443|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|101.5||||||90.0|95.6|107.9|||ANOVA|||||107.9|95.6|
71119535|NCT00759356|141744444|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|101.7||||||90.0|95.9|107.9|||ANOVA|log-transformation||||107.9|95.9|
71119536|NCT00835640|141744483|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|81.33||||||90.0|||||||To establish bioequivalence, the ratio of the mean must fall within 80-125.|||||
71119537|NCT00835640|141744484|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|87.87||||||90.0|||||||To establish bioequivalence, the ratio of the mean must fall within 80-125.|||||
71119538|NCT00835640|141744485|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|88.45||||||90.0|||||||To establish bioequivalence, the ratio of the mean must fall within 80-125.|||||
70943600|NCT01040403|141387590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.046|0.09|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.090|-0.046|
71119539|NCT00068250|141744490|OTHER||||||||||||||||||Dose escalation followed the standard 3+3 design, although up to six patients could be accrued per dose level before suspending accrual for toxicity evaluation. If none of the first three patients (0/3), or one of the first three and none of the second three (1/3 and 0/3), experience a DLT, then the current dose level would be considered acceptable, and the next dose opened. Otherwise, the current dose level would be considered too toxic. The highest dose achieved with an acceptable level of toxicity was to considered the Maximum Tolerable Dose (MTD). If at any time a grade 5 toxicity was observed, accrual will be suspended, and the Study Chair would review the event. Furthermore, if the cumulative incidence (obtained by time to event analysis), at any time, of combined acute/late DLTs estimated the toxicity rate to be greater than 30% at any dose level, then the Executive Committee will be notified, and the committee would determine whether to stop accrual.|||
71119540|NCT00068250|141744491|SUPERIORITY|||||||0.006|||||||One-sample z-test|||Null hypothesis: Two-year survival rate \<= 64%; Alternative hypothesis: Two-year survival rate \> 64%. The fixed survival rate for comparison comes from Radiation Therapy Oncology Group (RTOG) trial 9310. (RTOG 9310 does not fall within ClinicalTrials.gov registration/reporting requirements.)||||0.006
70943601|NCT01040403|141387591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.051|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.114|0.013|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.013|-0.114|
71119541|NCT00068250|141744492|OTHER|||||||0.82|||||||Chi-squared|One-sample test of proportions||RTOG 93-10 reported a pre-irradiation chemotherapy complete response rate of 59%. A chi-square test with a 0.20 one-sided significance level provides 81% power to detect the difference between a null hypothesis complete response rate of 59% and the alternative rate of 71% (a 20% increase) for the planned sample size of 52 patients.||||0.82
71119542|NCT00812006|141744494|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Generalized Linear Mixed Model|An unstructured covariance matrix was used to model the correlation among repeated measurements within a patient.||||||<0.001
71119543|NCT00812006|141744495|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Nominal p-value was adjusted under Benjamini and Hochberg's false discovery rate procedure for the multiple secondary endpoints at α=0.1 significance level.|Generalized Linear Mixed Model|A compound-symmetry covariance matrix was used to model the correlation among repeated measurements within a patient, due to a convergence issue.||||||<0.001
71119544|NCT00812006|141744496|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Nominal p-value was adjusted under Benjamini and Hochberg's false discovery rate procedure for the multiple secondary endpoints at α=0.1 significance level.|Generalized Linear Mixed Model|An unstructured covariance matrix was used to model the correlation among repeated measurements within a patient.||||||<0.001
71119545|NCT00812006|141744497|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Nominal p-value was adjusted under Benjamini and Hochberg's falsediscovery rate procedure for the multiple secondary endpoints at α=0.1 significance level.|Generalized Linear Mixed Model|An unstructured covariance matrix was used to model the correlation among repeated measurements within a patient.||||||<0.001
71119546|NCT00812006|141744498|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Nominal p-value was adjusted under Benjamini and Hochberg's false discovery rate procedure for the multiple secondary endpoints at α=0.1 significance level.|Generalized Linear Mixed Model|A compound-symmetry covariance matrix was used to model the correlation among repeated measurements within a patient, due to a convergence issue.||||||<0.001
71119547|NCT01686750|141744502|SUPERIORITY||Risk Ratio (RR)|1.31||||0.09|TWO_SIDED|95.0|0.95|1.81|||Prevalence ratio||Therefore, the exponentiated coefficients for intervention status represent the prevalence ratio with 95% confidence interval (CI) and are interpreted as the relative percentage difference in the outcome associated with the intervention.|We compared the sampling-weighted prevalence of outcomes at Integrated Care Centers (ICCs) and usual care from the evaluation survey. We used linear regression models that had terms for intervention status (integrated care vs usual care), stratum (PWID and MSM), and the baseline proportion of the outcome being assessed. Site-level proportions from both evaluation and baseline respondent-driven sampling were log transformed before being entered into the regression model.||1.81|0.95|0.09
71119548|NCT01686750|141744503|SUPERIORITY||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.8|1.5||||||||1.50|0.80|
71119549|NCT01686750|141744504|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.61|1.81||||||||1.81|0.61|
71119550|NCT01686750|141744505|SUPERIORITY||Risk Ratio (RR)|1.36|||||TWO_SIDED|95.0|0.77|2.41||||||||2.41|0.77|
71119551|NCT01686750|141744507|SUPERIORITY||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.65|1.28||||||||1.28|0.65|
71119552|NCT01686750|141744509|SUPERIORITY||Risk Ratio, log|1.44|||||TWO_SIDED|95.0|0.42|4.93||||||||4.93|0.42|
71119553|NCT01686750|141744510|SUPERIORITY||Risk Ratio, log|1.87|||||TWO_SIDED|95.0|0.49|7.16||||||||7.16|0.49|
70943602|NCT01040403|141387591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.055|0.071|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.071|-0.055|
70943603|NCT01040403|141387591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.011|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.074|0.053|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.053|-0.074|
71119554|NCT01686750|141744511|SUPERIORITY||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.53|1.56||||||||1.56|0.53|
71119555|NCT01686750|141744512|SUPERIORITY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-4.2|4.2||||||||4.2|-4.2|
71119556|NCT01686750|141744514|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.47|1.52||||||||1.52|0.47|
71119557|NCT01686750|141744516|SUPERIORITY||Mean Difference (Final Values)|-1.8|||||TWO_SIDED|95.0|-3.0|-0.6||||||||-0.6|-3.0|
70943604|NCT01040403|141387591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.004|0.122|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.122|-0.004|
71119558|NCT01686750|141744517|SUPERIORITY||Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.64|1.36||||||||1.36|0.64|
71119559|NCT02956044|141744518|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|108.73|||||TWO_SIDED|95.0|94.35|125.3|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric Least Square (LS) Mean was used as PK parameters||125.30|94.35|
71119560|NCT02956044|141744518|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|95.05|||||TWO_SIDED|90.0|84.73|106.63|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||106.63|84.73|
71119561|NCT02956044|141744518|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|89.44|||||TWO_SIDED|90.0|70.39|113.65|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||113.65|70.39|
71119562|NCT02956044|141744518|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|111.95|||||TWO_SIDED|90.0|97.02|129.19|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||129.19|97.02|
70943605|NCT01040403|141387591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.033|||TWO_SIDED|95.0|-0.024|0.104|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.104|-0.024|
71119563|NCT02956044|141744518|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|126.68|||||TWO_SIDED|90.0|112.08|143.17|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||143.17|112.08|
71119564|NCT02956044|141744518|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|98.48|||||TWO_SIDED|90.0|84.9|114.23|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||114.23|84.90|
71119565|NCT02956044|141744521|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|87.36|||||TWO_SIDED|90.0|80.02|95.38|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||95.38|80.02|
71119566|NCT02956044|141744521|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|103.24|||||TWO_SIDED|90.0|94.59|112.68|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||112.68|94.59|
71119567|NCT02956044|141744521|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|94.46|||||TWO_SIDED|90.0|80.34|111.06|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||111.06|80.34|
71119568|NCT02956044|141744521|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|[Ratio of Geometric LSM]|127.19|||||TWO_SIDED|90.0|110.33|146.62|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||146.62|110.33|
71119569|NCT02956044|141744521|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|[Ratio of Geometric LSM]|113.09|||||TWO_SIDED|90.0|107.61|118.86|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||118.86|107.61|
71119570|NCT02956044|141744521|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|[Ratio of Geometric LSM]|103.16|||||TWO_SIDED|90.0|99.3|107.17||||||Geometric LS Mean was used as PK parameters|Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|107.17|99.30|
70854906|NCT03758755|141198233|EQUIVALENCE|The a priori threshold for statistical significance was set at 0.05.||||||0.049|||||||t-test, 1 sided|||This analysis compares the change over time in degrees of knee extension between the BFR Therapy group and the No BFR Group from 2 weeks post-op to 12 weeks post-op. Underlying data was collected on a biweekly basis. This statistical test utilized the null hypothesis that there would be no difference between groups in the change in degrees of knee extension over time.||||0.049
70854907|NCT01634191|141198322|OTHER||Geometric Mean Ratio|113.0|||||TWO_SIDED|90.0|94.2|135.0|||||Geometric mean ratio (Elderly/Young) and 90% confidence interval (CI) of the ratio calculated from a 2-way ANOVA model, and presented as percentages.|To assess the effect of age on the PK of apremilast after a single 30 mg dose, a 2-way analysis of variance (ANOVA) model was performed on the log-transformed AUC0-t. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.||135|94.2|
70854908|NCT01634191|141198324|OTHER||Geometric Mean Ratio|128.0|||||TWO_SIDED|90.0|107.0|154.0|||||Geometric mean ratio (Female/Male) and 90% CI of the ratio calculated from a 2-way ANOVA model, and presented as percentages.|To assess the effect of sex on the PK of apremilast after a single 30 mg dose, a 2-way analysis of variance (ANOVA) model was performed on the log-transformed AUC0-t. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.||154|107|
70854909|NCT01634191|141198325|OTHER||Geometric Mean Ratio|113.0|||||TWO_SIDED|90.0|94.1|135.0|||||Geometric mean ratio (Elderly/Young) and 90% CI of the ratio calculated from a 2-way ANOVA model, and presented as percentages.|To assess the effect of age on the PK of apremilast after a single 30 mg dose, a 2-way analysis of variance (ANOVA) model was performed on the log-transformed AUC0-∞. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.||135|94.1|
70854910|NCT01634191|141198326|OTHER||Geometric Mean Ratio|131.0|||||TWO_SIDED|90.0|109.0|157.0|||||Geometric mean ratio (Female/Male) and 90% CI of the ratio calculated from a 2-way ANOVA model, and presented as percentages.|To assess the effect of sex on the PK of apremilast after a single 30 mg dose, a 2-way ANOVA model was performed on the log-transformed AUC0-∞. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.||157|109|
70854911|NCT01634191|141198327|OTHER||Geometric Mean Ratio|106.0|||||TWO_SIDED|90.0|90.5|123.0|||||Geometric mean ratio (Elderly/Young) and 90% CI of the ratio calculated from a 2-way ANOVA model, and presented as percentages.|To assess the effect of age on the PK of apremilast after a single 30 mg dose, a 2-way analysis of ANOVA model was performed on the log-transformed Cmax. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.||123|90.5|
70854912|NCT01634191|141198328|OTHER||Geometric Mean Ratio|108.0|||||TWO_SIDED|90.0|92.3|126.0|||||Geometric mean ratio (Female/Male) and 90% CI of the ratio calculated from a 2-way ANOVA model, and presented as percentages.|To assess the effect of sex on the PK of apremilast after a single 30 mg dose, a 2-way ANOVA model was performed on the log-transformed Cmax. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.||126|92.3|
70943606|NCT01040403|141387591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.082|0.045|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus +O 2.5/5|||0.045|-0.082|
70854913|NCT01634191|141198329|OTHER||Median Difference|0.5||||0.153|TWO_SIDED|90.0|0.0|2.0|||Wilcoxon rank-sum test||Median difference (Elderly - Young) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||2.00|0.000|0.153
70854914|NCT01634191|141198330|OTHER||Median Difference|0.5||||0.169|TWO_SIDED|90.0|0.0|2.0|||Wilcoxon rank-sum test||Median difference (Female - Male) and 90% CI of the difference calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||2.00|0.000|0.169
70854915|NCT02880956|141198359|SUPERIORITY||Least Squares (LS) Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.178||0.74|TWO_SIDED|95.0|-0.291|0.409||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.409|-0.291|0.740
70854916|NCT02880956|141198359|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.38|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70943607|NCT01040403|141387591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|0.047|0.174|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.174|0.047|
70943608|NCT01040403|141387591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|0.017|0.144|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.144|0.017|
71119571|NCT00098748|141744530|NON_INFERIORITY_OR_EQUIVALENCE|For hypothesis of superiority, if upper bound of 97.5% confidence interval (CI) of TX difference was \<0 log10 copies/mL, it was concluded that MVC regimen was superior to PBO meaning that MVC added to Optimized Background Therapy (OBT) provides an additional reduction in plasma HIV-1 RNA compared to OBT alone. If superiority could not be concluded, then a hypothesis of noninferiority was tested. If upper bound of CI is \<0.25 log10 copies/mL, noninferiority of MVC regimen to placebo was claimed.|Least squares mean|0.055|STANDARD_ERROR_OF_MEAN|0.2575|||TWO_SIDED|97.5|-0.528|0.638|||ANCOVA|TX difference adjusted for randomization strata. Bonferroni adjustment for multiple comparisons by use of 2-sided 97.5% CI to maintain alpha=0.05.|Negative values for change from baseline=benefit of TX; negative values for MVC versus (vs) PBO=advantage of MVC.|Maraviroc (MVC) QD versus placebo (PBO) treatment (TX) difference at Week 24. If upper bound of 97.5% confidence interval is \<0, it is concluded that dose is superior to PBO. If upper bound is \<0.25, it is concluded that MVC is non-inferior to PBO. Assumption: 79% of subjects are dual-tropic; total N=192 needed to be randomized to get N=150 dual-tropic. Standard deviation=0.8 with 2-sided p-value=0.025: 80% power for TX difference of 0.5 for change from baseline in log10-transformed viral load.||0.638|-0.528|
71119572|NCT00098748|141744530|SUPERIORITY_OR_OTHER||Least squares mean|-0.232|STANDARD_ERROR_OF_MEAN|0.2637|||TWO_SIDED|97.5|-0.829|0.364|||ANCOVA|TX difference adjusted for randomization strata. Bonferroni adjustment for multiple comparisons by use of 2-sided 97.5% CI to maintain alpha=0.05.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 24.||0.364|-0.829|
71119573|NCT00098748|141744530|SUPERIORITY_OR_OTHER||Least squares mean|0.229|STANDARD_ERROR_OF_MEAN|0.2567|||TWO_SIDED|97.5|-0.351|0.81|||ANCOVA|TX difference adjusted for randomization strata. Bonferroni adjustment for multiple comparisons by use of 2-sided 97.5% CI to maintain alpha=0.05.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC QD vs PBO treatment difference at Week 48.||0.810|-0.351|
71119574|NCT00098748|141744530|SUPERIORITY_OR_OTHER||Least squares mean|-0.261|STANDARD_ERROR_OF_MEAN|0.2628|||TWO_SIDED|97.5|-0.856|0.333|||ANCOVA|TX difference adjusted for randomization strata. Bonferroni adjustment for multiple comparisons by use of 2-sided 97.5% CI to maintain alpha=0.05.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 48.||0.333|-0.856|
71119575|NCT00098748|141744531|SUPERIORITY_OR_OTHER||difference in proportions|0.03|||||TWO_SIDED|95.0|-0.12|0.18|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 24.||0.18|-0.12|
71119576|NCT00098748|141744531|SUPERIORITY_OR_OTHER||difference in proportions|0.07|||||TWO_SIDED|95.0|-0.08|0.23|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 24.||0.23|-0.08|
71119577|NCT00098748|141744531|SUPERIORITY_OR_OTHER||difference in proportions|0.02|||||TWO_SIDED|95.0|-0.12|0.17|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 48.||0.17|-0.12|
71119578|NCT00098748|141744531|SUPERIORITY_OR_OTHER||difference in proportions|0.09|||||TWO_SIDED|95.0|-0.07|0.25|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 48.||0.25|-0.07|
71119579|NCT00098748|141744532|SUPERIORITY_OR_OTHER||difference in proportions|0.03|||||TWO_SIDED|95.0|-0.15|0.2|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 24.||0.20|-0.15|
71119580|NCT00098748|141744532|SUPERIORITY_OR_OTHER||difference in proportions|0.08|||||TWO_SIDED|95.0|-0.1|0.26|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 24.||0.26|-0.10|
71119581|NCT00098748|141744532|SUPERIORITY_OR_OTHER||difference in proportions|-0.06|||||TWO_SIDED|95.0|-0.22|0.1|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 48.||0.10|-0.22|
71119582|NCT00098748|141744532|SUPERIORITY_OR_OTHER||difference in proportions|0.11|||||TWO_SIDED|95.0|-0.07|0.28|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 48.||0.28|-0.07|
71119583|NCT00098748|141744533|SUPERIORITY_OR_OTHER||difference in proportions|-0.05|||||TWO_SIDED|95.0|-0.21|0.12|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 24.||0.12|-0.21|
71119584|NCT00098748|141744533|SUPERIORITY_OR_OTHER||difference in proportions|0.08|||||TWO_SIDED|95.0|-0.1|0.26|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 24.||0.26|-0.10|
71119585|NCT00098748|141744533|SUPERIORITY_OR_OTHER||difference in proportions|-0.02|||||TWO_SIDED|95.0|-0.18|0.13|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 48.||0.13|-0.18|
71119586|NCT00098748|141744533|SUPERIORITY_OR_OTHER||difference in proportions|0.12|||||TWO_SIDED|95.0|-0.04|0.29|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 48.||0.29|-0.04|
71119587|NCT00098748|141744534|SUPERIORITY_OR_OTHER||difference in proportions|0.07|||||TWO_SIDED|95.0|-0.07|0.2|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 24.||0.20|-0.07|
71119588|NCT00098748|141744534|SUPERIORITY_OR_OTHER||difference in proportions|0.11|||||TWO_SIDED|95.0|-0.03|0.26|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO difference in proportions at Week 24.||0.26|-0.03|
71119589|NCT00098748|141744534|SUPERIORITY_OR_OTHER||difference in proportions|-0.04|||||TWO_SIDED|95.0|-0.18|0.1|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 48.||0.10|-0.18|
71119590|NCT00098748|141744534|SUPERIORITY_OR_OTHER||difference in proportions|0.06|||||TWO_SIDED|95.0|-0.1|0.21|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 48.||0.21|-0.10|
70854917|NCT02880956|141198359|SUPERIORITY||LS Mean of Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.176||0.367|TWO_SIDED|95.0|-0.504|0.187||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.187|-0.504|0.367
71119591|NCT00098748|141744535|SUPERIORITY_OR_OTHER||Least squares mean|23.927|STANDARD_ERROR_OF_MEAN|12.8025|||TWO_SIDED|95.0|-1.359|49.213|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC QD vs PBO treatment difference at Week 24.||49.213|-1.359|
71119592|NCT00098748|141744535|SUPERIORITY_OR_OTHER||Least squares mean|26.679|STANDARD_ERROR_OF_MEAN|13.0678|||TWO_SIDED|95.0|0.869|52.49|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 24.||52.490|0.869|
71119593|NCT00098748|141744535|SUPERIORITY_OR_OTHER||Least squares mean|14.61|STANDARD_ERROR_OF_MEAN|16.412|||TWO_SIDED|95.0|-17.8|47.03|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC QD vs PBO treatment difference at Week 48.||47.03|-17.80|
71119594|NCT00098748|141744535|SUPERIORITY_OR_OTHER||Least squares mean|27.71|STANDARD_ERROR_OF_MEAN|16.754|||TWO_SIDED|95.0|-5.38|60.8|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 48.||60.80|-5.38|
71119595|NCT00098748|141744536|SUPERIORITY_OR_OTHER||Least squares mean|234.499|STANDARD_ERROR_OF_MEAN|80.799|||TWO_SIDED|95.0|74.913|394.084|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC QD vs PBO treatment difference at Week 24.||394.084|74.913|
71119596|NCT00098748|141744536|SUPERIORITY_OR_OTHER||Least squares mean|188.817|STANDARD_ERROR_OF_MEAN|83.4484|||TWO_SIDED|95.0|23.999|353.635|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 24.||353.635|23.999|
70854918|NCT02880956|141198359|SUPERIORITY||Effect size/pooled SD|0.12|STANDARD_DEVIATION|1.33|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70854919|NCT02880956|141198359|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.18||0.843|TWO_SIDED|95.0|-0.318|0.389||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.389|-0.318|0.843
70854920|NCT02880956|141198359|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|1.37|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70854921|NCT02880956|141198359|SUPERIORITY||LS Mean of Difference|0.08|STANDARD_ERROR_OF_MEAN|0.222||0.703|TWO_SIDED|95.0|-0.351|0.52||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.520|-0.351|0.703
70854922|NCT02880956|141198359|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|1.62|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70854923|NCT02880956|141198359|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.218||0.947|TWO_SIDED|95.0|-0.442|0.413||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.413|-0.442|0.947
70854924|NCT02880956|141198359|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|1.69|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70854925|NCT02880956|141198359|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.222||0.732|TWO_SIDED|95.0|-0.514|0.361||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.361|-0.514|0.732
70854926|NCT02880956|141198359|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|1.51|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71119597|NCT00098748|141744536|SUPERIORITY_OR_OTHER||Least squares mean|155.94|STANDARD_ERROR_OF_MEAN|87.304|||TWO_SIDED|95.0|-16.49|328.37|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC QD vs PBO treatment difference at Week 48.||328.37|-16.49|
71119598|NCT00098748|141744536|SUPERIORITY_OR_OTHER||Least squares mean|182.91|STANDARD_ERROR_OF_MEAN|90.174|||TWO_SIDED|95.0|4.81|361.02|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 48.||361.02|4.81|
71119599|NCT00098748|141744537|SUPERIORITY_OR_OTHER|||||||0.7524||95.0|||||Log Rank|||MVC QD vs PBO at Week 24. Kaplan-Meier survival estimates. TX difference evaluated by log-rank test.||||0.7524
71119600|NCT00098748|141744537|SUPERIORITY_OR_OTHER|||||||0.254||95.0|||||Log Rank|||MVC BID vs PBO at Week 24. Kaplan-Meier survival estimates. TX difference evaluated by log-rank test.||||0.2540
71119601|NCT00098748|141744537|SUPERIORITY_OR_OTHER|||||||0.8243||95.0|||||Log Rank|||MVC QD vs PBO at Week 48. Kaplan-Meier survival estimates. TX difference evaluated by log-rank test.||||0.8243
71119602|NCT00098748|141744537|SUPERIORITY_OR_OTHER|||||||0.6657||95.0|||||Log Rank|||MVC BID vs PBO at Week 48. Kaplan-Meier survival estimates. TX difference evaluated by log-rank test.||||0.6657
70854927|NCT02880956|141198359|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.305||0.939|TWO_SIDED|95.0|-0.623|0.576||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.576|-0.623|0.939
70854928|NCT02880956|141198359|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|2.19|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70854929|NCT02880956|141198359|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.299||0.872|TWO_SIDED|95.0|-0.637|0.54||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.540|-0.637|0.872
70854930|NCT02880956|141198359|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|2.27|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71119603|NCT00098748|141744538|SUPERIORITY_OR_OTHER||Least squares mean|0.069|STANDARD_ERROR_OF_MEAN|0.2356|||TWO_SIDED|95.0|-0.396|0.535|||ANCOVA|TX difference adjusted for randomization strata.||MVC QD vs PBO treatment difference at Week 24.||0.535|-0.396|
71119604|NCT00098748|141744538|SUPERIORITY_OR_OTHER||Least squares mean|-0.218|STANDARD_ERROR_OF_MEAN|0.2413|||TWO_SIDED|95.0|-0.694|0.258|||ANCOVA|TX difference adjusted for randomization strata.||MVC BID vs PBO treatment difference at Week 24.||0.258|-0.694|
71119605|NCT00098748|141744538|SUPERIORITY_OR_OTHER||Least squares mean|0.209|STANDARD_ERROR_OF_MEAN|0.2388|||TWO_SIDED|95.0|-0.262|0.681|||ANCOVA|TX difference adjusted for randomization strata.||MVC QD vs PBO treatment difference at Week 48.||0.681|-0.262|
71119606|NCT00098748|141744538|SUPERIORITY_OR_OTHER||Least squares mean|-0.284|STANDARD_ERROR_OF_MEAN|0.2445|||TWO_SIDED|95.0|-0.767|0.199|||ANCOVA|TX difference adjusted for randomization strata.||MVC BID vs PBO treatment difference at Week 48.||0.199|-0.767|
71119607|NCT01081301|141744559|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value were not adjusted for multiple comparisons and a p-value of 0.05 was used for statistical significance.|ANOVA|Modified version of ANOVA as it overcomes the shortcoming of the ANOVA model by taking into account unbalanced data and repeated measures.||Generalized estimating equations were used to determine change in patterns of the Herth Hope Index over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.||||<0.05
70854931|NCT02880956|141198359|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.305||0.773|TWO_SIDED|95.0|-0.688|0.512||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.512|-0.688|0.773
70854932|NCT02880956|141198359|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|2.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70943609|NCT01040403|141387591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|0.005|0.132|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.132|0.005|
71119608|NCT01081301|141744560|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value were not adjusted for multiple comparisons and a p-value of 0.05 was used for statistical significance.|ANOVA|Modified version of ANOVA as it overcomes the shortcoming of the ANOVA model by taking into account unbalanced data and repeated measures.||Generalized estimating equations were used to determine change in patterns of SF-12v2 Mental health scores over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.||||<0.05
71119609|NCT01081301|141744561|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value were not adjusted for multiple comparisons and a p-value of 0.05 was used for statistical significance.|ANOVA|Modified version of ANOVA as it overcomes the shortcoming of the ANOVA model by taking into account unbalanced data and repeated measures||Generalized estimating equations were used to determine change in patterns of General Self Efficacy Scale scores over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.||||<0.05
70943610|NCT01040403|141387591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.033|||TWO_SIDED|95.0|-0.094|0.034|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.034|-0.094|
70854933|NCT02880956|141198359|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.387||0.848|TWO_SIDED|95.0|-0.834|0.686||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.686|-0.834|0.848
70854934|NCT02880956|141198359|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|2.64|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70854935|NCT02880956|141198359|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.38||0.869|TWO_SIDED|95.0|-0.81|0.684||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.684|-0.810|0.869
70854936|NCT02880956|141198359|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|2.75|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70943611|NCT01040403|141387591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.105|0.021|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.021|-0.105|
71080729|NCT02171429|141667856|SUPERIORITY||Difference in Response Rates|-2.5||||0.6726|TWO_SIDED|95.0|-13.83|9.01||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||9.01|-13.83|0.6726
71080730|NCT02171429|141667857|SUPERIORITY||Difference in Response Rates|1.2||||1|TWO_SIDED|95.0|-6.98|9.26||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 3 of the testing procedure; please refer to the statistical analysis plan for details.||9.26|-6.98|1
70854937|NCT02880956|141198359|SUPERIORITY||LS Mean of Difference|0.16|STANDARD_ERROR_OF_MEAN|0.389||0.679|TWO_SIDED|95.0|-0.603|0.925||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.925|-0.603|0.679
71080731|NCT02171429|141667858|SUPERIORITY||Difference in Response Rates|9.4||||0.2372|TWO_SIDED|95.0|-4.31|21.95||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 1 of the testing procedure; please refer to the statistical analysis plan for details.||21.95|-4.31|0.2372
71080732|NCT02171429|141667858|SUPERIORITY||Difference in Response Rates|-3.5||||0.5341|TWO_SIDED|95.0|-14.76|7.82||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||7.82|-14.76|0.5341
71080733|NCT02171429|141667859|SUPERIORITY||Difference in Response Rates|1.9||||1|TWO_SIDED|95.0|-6.04|9.88||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 3 of the testing procedure; please refer to the statistical analysis plan for details.||9.88|-6.04|1
71080734|NCT02171429|141667860|SUPERIORITY||Difference in Remission Rates|11.2||||0.2372|TWO_SIDED|95.0|0.59|19.76||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||19.76|0.59|0.2372
71080735|NCT02171429|141667860|SUPERIORITY||Difference in Remission Rates|-7.5||||0.1192|TWO_SIDED|95.0|-17.2|2.33||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||2.33|-17.20|0.1192
71080736|NCT02171429|141667861|SUPERIORITY||Difference in Remission Rates|-3.5||||1|TWO_SIDED|95.0|-10.27|3.3||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||3.30|-10.27|1
71080737|NCT02171429|141667862|SUPERIORITY||Difference in Remission Rates|9.6||||0.2729|TWO_SIDED|95.0|-4.71|22.02||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||22.02|-4.71|0.2729
70854938|NCT02880956|141198359|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|2.72|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71080738|NCT02171429|141667862|SUPERIORITY||Difference in Remission Rates|-14.8||||0.0215|TWO_SIDED|95.0|-26.97|-2.04||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||-2.04|-26.97|0.0215
71080739|NCT02171429|141667863|SUPERIORITY||Difference in Remission Rates|-0.3||||1|TWO_SIDED|95.0|-9.13|8.45||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||8.45|-9.13|1
71080740|NCT02171429|141667864|SUPERIORITY|||||||0.1729||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and RB score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||||0.1729
71080741|NCT02171429|141667864|SUPERIORITY|||||||0.2864||||||Nominal p-value; it has not been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and RB score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||||0.2864
71080742|NCT02171429|141667865|SUPERIORITY|||||||1||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and RB score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||||1
71080743|NCT02171429|141667866|SUPERIORITY|||||||0.1729||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and SF score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||||0.1729
70854939|NCT02880956|141198368|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.693||0.562|TWO_SIDED|95.0|-1.764|0.96||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.960|-1.764|0.562
71080744|NCT02171429|141667866|SUPERIORITY|||||||0.4174||||||Nominal p-value; it has not been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and SF score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||||0.4174
70943612|NCT01040403|141387591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.075|0.052|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.052|-0.075|
71119610|NCT01081301|141744562|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The p-value were not adjusted for multiple comparisons and a p-value of 0.05 was used for statistical significance.|ANOVA|Modified version of ANOVA as it overcomes the shortcoming of the ANOVA model by taking into account unbalanced data and repeated measures.||Generalized estimating equations were used to determine change in patterns of Non Death Revised Grief Experience Inventory scores over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.||||>0.05
71119611|NCT01081301|141744563|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value were not adjusted for multiple comparisons and a p-value of 0.05 was used for statistical significance.|ANOVA|Modified version of ANOVA as it overcomes the shortcoming of the ANOVA model by taking into account unbalanced data and repeated measures.||Generalized estimating equations were used to determine change in patterns of SF-12v2 Physical health scores over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.||||<0.05
71119612|NCT03551665|141744583|OTHER||Mean Difference (Final Values)|0.029||||0.036|TWO_SIDED|95.0|0.002|0.056|||Regression, Linear|||These data are the immediate improvements (base 2 - post 1) in the MS group.||0.056|.002|0.036
71119613|NCT03551665|141744584|OTHER||Spearman's Rho|0.019||||0.92|||||||Spearman Correlation|||We correlated cognition (SDMT; above) to the improvement in performance (margin of stability) to to determine whether cognition predicted improvement in stepping outcomes.||||.92
71119614|NCT03551665|141744585|OTHER||Mean Difference (Final Values)|0.026||||0.119||95.0|-0.007|0.059|||Regression, Linear|||We assessed the change in reactive step length before (Baseline 2) to immediately after (post 1) training in the MS group||0.059|-0.007|0.119
71119615|NCT03551665|141744586|OTHER||Mean Difference (Final Values)|-0.041||||0.012||95.0|-0.073|-0.009|||Regression, Linear|||We assessed the change in reactive step latency before (Baseline 2) to immediately after (post 1) training in the MS group||-0.009|-0.073|0.012
71119616|NCT05538312|141744587|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|168.9|||||TWO_SIDED|90.0|157.66|180.94|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed AUCinf was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||180.94|157.66|
71119617|NCT05538312|141744588|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|152.19|||||TWO_SIDED|90.0|136.9|169.18|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed Cmax was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||169.18|136.90|
71119618|NCT05538312|141744589|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|161.99|||||TWO_SIDED|90.0|148.7|176.47|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed AUC120 was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||176.47|148.70|
71119619|NCT05538312|141744590|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|153.13|||||TWO_SIDED|90.0|138.51|169.3|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed Cmax was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||169.30|138.51|
71119620|NCT05538312|141744591|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|171.63|||||TWO_SIDED|90.0|159.96|184.15|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed AUClast was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||184.15|159.96|
71119621|NCT05538312|141744592|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|157.8|||||TWO_SIDED|90.0|146.51|169.95|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed AUC120 was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||169.95|146.51|
70943613|NCT01040403|141387592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.759|STANDARD_ERROR_OF_MEAN|4.189|||TWO_SIDED|95.0|10.533|26.985|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-3h||26.985|10.533|
71119622|NCT05538312|141744597|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|192.86|||||TWO_SIDED|90.0|178.86|207.94|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed AUClast was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||207.94|178.86|
71119623|NCT01545232|141744675|SUPERIORITY_OR_OTHER||Adjusted Relative Risk|0.75||||0.12|TWO_SIDED|95.0|0.52|1.08|||Mantel Haenszel|The critical level for significance (p\<0.044) was adjusted for two interim analyses, and all tests were conducted using two-sided tests.||Initial sample size (580) planned to detect a clinically meaningful 10% difference in 24-hour mortality (11% vs. 21%) supported by prior data. Data Safety Monitoring Board (DSMB) increased sample size to 680 according to trial's adaptive design. With 680 pts. \& given the final observed mortality proportions in 1:1:1 group, PROPPR had 95% power to detect the pre-specified 10% difference at 24 hours if such differences existed.||1.08|0.52|0.12
71119624|NCT01545232|141744676|SUPERIORITY_OR_OTHER||Adjusted Relative Risk|0.86||||0.26|TWO_SIDED|95.0|0.65|1.12|||Mantel Haenszel|The critical level for significance (p\<0.044) was adjusted for two interim analyses, and all tests were conducted using two-sided tests.||Initial sample size of 580 planned to detect clinically meaningful a 12% difference in 30-day mortality (23% vs. 35%),supported by prior data. DSMB increased sample size to 680 according to trial's adaptive design. With 680 patients \& given final observed mortality proportions in the 1:1:1 group, PROPPR had 92% power to detect the pre-specified 12% difference at 30 days, if such differences existed.||1.12|0.65|0.26
71119625|NCT01545232|141744678|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||van Elteren's test for medians|||||||0.83
71119626|NCT01545232|141744679|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||van Elteren's test for medians|||||||0.44
71119627|NCT01545232|141744681|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||van Elteren's test for medians|||||||0.11
71119628|NCT01545232|141744682|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.8|||||TWO_SIDED|95.0|-2.8|8.3||||||||8.3|-2.8|
71119629|NCT01545232|141744683|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-0.8|1.7||||||||1.7|-0.8|
71119630|NCT01545232|141744684|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||generalized logit model regression|||||||0.37
71119631|NCT01545232|141744685|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||van Elteren's test for medians|||||||0.14
71119632|NCT01545232|141744686|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||van Elteren's test for medians|||||||0.10
71119633|NCT00798317|141744698|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.13|||<|0.001|TWO_SIDED|95.0|1.97|17.0||Comparing placebo and ocriplasmin|Fisher Exact|||||17.00|1.97|<0.001
71119634|NCT00378599|141744701|SUPERIORITY_OR_OTHER||Binomial Approximation|0.288|||||TWO_SIDED|95.0|0.21|0.38||||||||0.38|0.21|
71119635|NCT03920293|141744840|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.49|=|0.0009|TWO_SIDED|95.0|-2.6|-0.7||Statistical significance was tested at α=0.05.|MMRM|||||-0.7|-2.6|=0.0009
71119636|NCT03272828|141744858|SUPERIORITY|||||||0.63|||||||Fisher Exact|||||||0.63
71119637|NCT03272828|141744859|SUPERIORITY|||||||0.06|||||||Unequal-variance 2-sample t-test|||||||0.06
71119638|NCT03272828|141744860|SUPERIORITY|||||||0.45|||||||Unequal-variance 2-sample t-test|||||||0.45
71119639|NCT01920568|141744871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.316|||<|0.0001|TWO_SIDED|95.0|-0.44|-0.192|||ANCOVA||Primary analysis evaluated the log transformed chg from BL, i.e. log\[(Wk 13 uNTx/Cr) / (BL uNTx/Cr)\] by ANCOVA model with trt group as main effect and the stratification factor (breast cancer, yes or no) and log transformed BL value as covariates.|||-0.192|-0.440|<0.0001
71119640|NCT01920568|141744872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.316|||<|0.0001|TWO_SIDED|95.0|-0.444|-0.188|||ANCOVA||Secondary analysis evaluated the log transformed chg from BL, ie log\[(Wk 13 uNTx/Cr)/(BL uNTx/Cr)\] by ANCOVA model with trt group as main effect and the stratification factor (Chinese participants, yes or no) and log transformed BL value|||-0.188|-0.444|<0.0001
71119641|NCT01920568|141744873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.366|||<|0.0001|TWO_SIDED|95.0|-0.539|-0.193|||ANCOVA||Secondary analysis evaluated the log transformed chg from BL, i.e. log\[(Wk 13 uNTx/Cr) / (BL uNTx/Cr)\] by ANCOVA model with trt group as main effect, stratification factor (Breast cancer, yes or no) and log transformed BL value as covariates.|||-0.193|-0.539|<0.0001
71119642|NCT06276881|141744889|SUPERIORITY|||||||0.37|||||||t-test, 1 sided||||Multiple regression analysis|||.37
71119643|NCT06276881|141744890|SUPERIORITY|||||||0.07|||||||ANOVA|||||||.07
71119644|NCT02780856|141744914|SUPERIORITY||||||<|0.0001|||||||exact binomial|An exact binomial test was used and an exact 97.5% Confidence Level using the Clopper-Pearson method was calculated||The null and alternative hypothesis for each tooth population was of chance agreement (50%) and was tested against an exact binomial one-sided 97.5% confidence interval||||<0.0001
71119645|NCT02780856|141744914|SUPERIORITY||||||<|0.0001|||||||exact binomial|An exact binomial test was used and an exact 97.5% Confidence Level using the Clopper-Pearson method was calculated||The null and alternative hypothesis for each tooth population was of chance agreement (50%) and was tested against an exact binomial one-sided 97.5% confidence interval||||<0.0001
71119646|NCT03640052|141744918|SUPERIORITY||Mean Difference (Final Values)|3.6|||>|0.5|TWO_SIDED||||||Mixed Models Analysis|||mean difference vs Placebo||||>0.5
71119647|NCT03640052|141744918|SUPERIORITY||Mean Difference (Net)|-2.0|||>|0.5|TWO_SIDED||||||Mixed Models Analysis|||mean difference vs Placebo||||>0.5
71119648|NCT03640052|141744918|SUPERIORITY||Mean Difference (Net)|-6.8|||>|0.5|TWO_SIDED||||||Mixed Models Analysis|||mean difference vs Placebo||||>0.5
71119649|NCT03640052|141744918|SUPERIORITY||Mean Difference (Net)|-11.7||||0.33|TWO_SIDED||||||Mixed Models Analysis|||mean difference vs Placebo||||0.33
71119650|NCT03640052|141744919|SUPERIORITY|||||||0.12|||||||Mixed Models Analysis|||||||0.12
71119651|NCT04239222|141744933|SUPERIORITY|A sample size of 22 subjects was required to provide 80% power to detect a difference of 5 points on the PLUS-M scale using Wilcoxon's matched pairs signed ranks test and alpha of 0.05. A standard deviation of 7.7 was used to calculate the sample size.|Mean Difference (Final Values)|1.02|STANDARD_DEVIATION|4.17||0.286|TWO_SIDED||||||Wilcoxon Signed Rank Test||Difference represents Revo-M - Everyday Foot,|HO: μRevo-M ≤ μEveryday, μRevo-M is the mean PLUS-M score using the Revo-M and μEveryday is the mean PLUS-M score using the Everyday foot at baseline.|2-sided Wilcoxon matched pairs signed ranks test, n=23 (11 negative, 8 positive and 4 null), Z=-1.066.|||0.286
71119652|NCT04239222|141744934|SUPERIORITY|A sample size of 21 subjects was required to provide 80% power to detect a difference of 0.2 points in the TAPES-AR score using Wilcoxon's matched pairs signed ranks test and alpha of 0.05. A standard deviation of 0.3 was used to calculate the sample size.|Mean Difference (Final Values)|-0.094|STANDARD_DEVIATION|0.212||0.031|TWO_SIDED||||||Wilcoxon Signed Rank Test||Difference represents Revo-M - Everyday Foot.|HO: μRevo-M ≥ μEveryday, μRevo-M is the mean TAPES-AR score using the Revo-M and μEveryday is the mean TAPES-AR score using the Everyday foot at baseline.|2-sided Wilcoxon matched pairs signed ranks test, n=23 (5 negative, 13 positive and 5 null), Z=-2.156|||0.031
71119653|NCT04239222|141744936|SUPERIORITY||Mean Difference (Final Values)|0.331|STANDARD_DEVIATION|8.29||0.421|TWO_SIDED||||||Wilcoxon Signed Rank Test||Difference represents Revo-M - Everyday Foot.|HO: μRevo-M ≤ μEveryday, μRevo-M is the mean ABC score using the Revo-M and μEveryday is the mean ABC score using the Everyday foot at baseline.|2-sided Wilcoxon matched pairs signed ranks test, n=23 (12 negative, 7 positive and 4 null), Z=-0.805.|||0.421
71119654|NCT04239222|141744937|SUPERIORITY||Mean Difference (Final Values)|0.087|STANDARD_DEVIATION|0.844||0.443|TWO_SIDED||||||Wilcoxon Signed Rank Test||Difference represents Revo-M - Everyday Foot.|HO: μRevo-M ≤ μEveryday, μRevo-M is the mean TAPES-FUN score using the Revo-M and μEveryday is the mean TAPES-FUN score using the Everyday foot at baseline.|2-sided Wilcoxon matched pairs signed ranks test, n=23 (6 negative, 9 positive and 8 null), Z=-0.767.|||0.443
71119655|NCT01468233|141744961|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|31.5|||<|0.001|TWO_SIDED|95.0|20.7|42.2||P-value adjusted for baseline Hurley Stage and for baseline antibiotic use (Y/N).|Cochran-Mantel-Haenszel|||||42.2|20.7|<0.001
71119656|NCT01468233|141744961|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|25.5|||<|0.001|TWO_SIDED|95.0|10.5|40.5||P-value adjusted for baseline antibiotic use (Y/N).|Cochran-Mantel-Haenszel|||||40.5|10.5|<0.001
71119657|NCT01468233|141744961|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|38.1|||<|0.001|TWO_SIDED|95.0|22.8|53.3||P-value adjusted for baseline antibiotic use (Y/N).|Cochran-Mantel-Haenszel|||||53.3|22.8|<0.001
71119658|NCT01468233|141744962|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|19.5|||=|0.01|TWO_SIDED|95.0|4.7|34.2||P-value adjusted for baseline antibiotics use (Y/N).|Cochran-Mantel-Haenszel|||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.||34.2|4.7|=0.01
71119659|NCT01468233|141744963|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|25.1|||<|0.001|TWO_SIDED|95.0|12.7|37.6||P-value adjusted for baseline Hurley Stage and antibiotics use (Y/N).|Cochran-Mantel-Haenszel|||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.||37.6|12.7|<0.001
71119660|NCT01468233|141744964|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-19.4|||<|0.001|TWO_SIDED|95.0|-28.6|-10.1||P-value calculated from ANCOVA with stratum (baseline Hurley Stage and antibiotics use), baseline value, and treatment as covariates.|ANCOVA|||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.||-10.1|-28.6|<0.001
71119661|NCT03549871|141745005|SUPERIORITY||ABR ratio|0.389|||=|0.0008|TWO_SIDED|95.0|0.224|0.675||The threshold for significance was \<0.05.|Repeated measures NB regression model|||Analyzed using repeated measures NB model with fixed effect of treatment period (fitusiran efficacy period or factor/BPA prophylaxis period) and robust sandwich covariance matrix was constructed to account for within participant dependence, logarithm of duration (in years) that each participant spends in each study period matching BE data being analyzed as an offset variable.||0.675|0.224|=0.0008
71119662|NCT03549871|141745007|SUPERIORITY||ABR ratio|0.444|||||TWO_SIDED|95.0|0.234|0.842||||||||0.842|0.234|
71119663|NCT03549871|141745009|SUPERIORITY||ABR ratio|0.485|||||TWO_SIDED|95.0|0.259|0.91||||||||0.910|0.259|
71080745|NCT02171429|141667867|SUPERIORITY|||||||1||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and SF score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||||1
71119664|NCT01133626|141745022|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be demonstrated if the lower limit of a two-sided 95% CI for the geometric mean ratio of BDP HFA 320 mcg/day to placebo was greater than 0.80.|geometric mean ratio|0.96|||||TWO_SIDED|95.0|0.87|1.06|||ANCOVA|||||1.06|0.87|
71119665|NCT00294645|141745069|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Modified Peto-Peto|A one-sided test was used.||Null hypothesis: control rate = remote rate||||<0.0001
71119666|NCT01444027|141745096|SUPERIORITY|||||||0.002||||||Bonferroni adjusted p-value for 3 pairwise comparisons|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status||||||0.002
71119667|NCT01444027|141745096|SUPERIORITY|||||||0.9||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|||||||0.90
71119668|NCT01444027|141745096|SUPERIORITY|||||||0.002||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.002
71119669|NCT01444027|141745097|SUPERIORITY|||||||0.001||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for the baseline value of the measure, hospice agency, and bereaved status.||||||0.001
71119670|NCT01444027|141745097|SUPERIORITY|||||||0.48||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.48
71119671|NCT01444027|141745097|SUPERIORITY|||||||0.01||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||.01
71119672|NCT01444027|141745098|SUPERIORITY|||||||0.001||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.001
71119673|NCT01444027|141745098|SUPERIORITY|||||||0.83|||||||Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.83
71119674|NCT01444027|141745098|SUPERIORITY|||||||0.001||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.001
71119675|NCT01444027|141745099|SUPERIORITY|||||||0.003||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.003
71119676|NCT01444027|141745099|SUPERIORITY|||||||0.16||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.16
71119677|NCT01444027|141745099|SUPERIORITY|||||||0.17||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.17
71119678|NCT01444027|141745100|SUPERIORITY|||||||0.001||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.001
71119679|NCT01444027|141745100|SUPERIORITY|||||||0.78||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.78
71119680|NCT01444027|141745100|SUPERIORITY|||||||0.004||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.004
71119681|NCT00737711|141745102|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Paired t-test was used to estimation of p-value.|t-test, 2 sided|||||||<0.0001
71119682|NCT01263015|141745132|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority could be concluded if the lower bound of a two-sided 95% confidence interval for the difference (DTG + ABC/3TC minus EFV/TDF/FTC) in percentages between the two treatment arms was \> -10%.|Difference in percentage|7.3||||0.003|TWO_SIDED|95.0|2.3|12.2||P-value is for the test of superiority.|Wilcoxon (Mann-Whitney)||The estimated value reflects the percentage on DTG + ABC/3TC minus the percentage on EFV/TDF/FTC.|||12.2|2.3|0.003
71119683|NCT01263015|141745134|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority could be concluded if the lower bound of a two-sided 95% confidence interval for the difference (DTG + ABC/3TC minus EFV/TDF/FTC) in percentages between the two treatment arms was \> -10%.|Difference in percentage|7.1||||0.016|TWO_SIDED|95.0|1.2|13.1||P-value is for the test of superiority.|Wilcoxon (Mann-Whitney)||Week 96:The estimated value reflects the percentage on DTG + ABC/3TC minus the percentage on EFV/TDF/FTC.|||13.1|1.2|0.016
71119684|NCT01263015|141745134|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority could be concluded if the lower bound of a two-sided 95% confidence interval for the difference (DTG + ABC/3TC minus EFV/TDF/FTC) in percentages between the two treatment arms was \>-10%.|Difference in percentage|8.3||||0.01|TWO_SIDED|95.0|1.9|14.6||P-value is for the test of superiority.|Wilcoxon (Mann-Whitney)||Week 144:Estimated value reflects the percentage on DTG + ABC/3TC minus the percentage on EFV/TDF/FTC.|||14.6|1.9|0.010
71119685|NCT01263015|141745137|NON_INFERIORITY_OR_EQUIVALENCE|Adjusted mean is the estimated mean change from baseline (BL) in CD4 + Cell Count at Week 144 in each arm calculated from a repeated measures model including the following covariates: treatment, visit, BL plasma HIV-1 RNA, BL CD4 cell count, treatment\*visit interaction, BL HIV-1 RNA\*visit interaction and BL CD4 cell count\*visit interaction. No assumptions were made about the correlations between a par.'s readings of CD4 i.e. the correlation matrix for within-subject errors is unstructured.||||||0.003||95.0||||P-value is for the test of superiority.|Repeated Measure Mixed Model|||||||0.003
71119686|NCT03571672|141745143|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.08|STANDARD_DEVIATION|5.98||0.868|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.868
71119687|NCT03571672|141745143|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.23|STANDARD_DEVIATION|5.445||0.606|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.606
71119688|NCT03571672|141745143|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.43|STANDARD_DEVIATION|4.212||0.224|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.224
71119689|NCT03571672|141745144|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|0.32|STANDARD_DEVIATION|6.682||0.715|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.715
71119690|NCT03571672|141745144|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|6.526||0.956|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.956
71119691|NCT03571672|141745144|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.17|STANDARD_DEVIATION|4.584||0.771|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.771
71119692|NCT03571672|141745145|OTHER||Intra-class Correlation Coefficient|0.959|||||TWO_SIDED|95.0|0.944|0.97||||||Inter-Reader Variability Echo Enhanced||0.970|0.944|
71119693|NCT03571672|141745145|OTHER||Intra-class Correlation Coefficient|0.95|||||TWO_SIDED|95.0|0.931|0.964||||||Inter-Reader Variability Echo Unenhanced||0.964|0.931|
71119694|NCT03571672|141745145|OTHER||Intra-class Correlation Coefficient|0.957|||||TWO_SIDED|95.0|0.941|0.969||||||Inter-Reader Variability Echo Enhanced||0.969|0.941|
71119695|NCT03571672|141745145|OTHER||Intra-class Correlation Coefficient|0.934|||||TWO_SIDED|95.0|0.909|0.952||||||Inter-Reader Variability Echo Unenhanced||0.952|0.909|
71119696|NCT03571672|141745145|OTHER||Intra-class Correlation Coefficient|0.961|||||TWO_SIDED|95.0|0.946|0.972||||||Inter-Reader Variability Echo Enhanced||0.972|0.946|
71119697|NCT03571672|141745145|OTHER||Intra-class Correlation Coefficient|0.937|||||TWO_SIDED|95.0|0.913|0.954||||||Inter-Reader Variability Echo Unenhanced||0.954|0.913|
71119698|NCT03571672|141745146|OTHER||Intra-class Correlation Coefficient|0.988|||||TWO_SIDED|95.0|0.984|0.992||||||Inter-reader Variability End Diastolic Echo Enhanced||0.992|0.984|
71119699|NCT03571672|141745146|OTHER||Intra-class Correlation Coefficient|0.986|||||TWO_SIDED|95.0|0.981|0.99||||||Inter-reader Variability End Diastolic Echo Unenhanced||0.990|0.981|
71119700|NCT03571672|141745146|OTHER||Intra-class Correlation Coefficient|0.96|||||TWO_SIDED|95.0|0.945|0.971||||||Inter-reader Variability End Diastolic Echo Enhanced||0.971|0.945|
71119701|NCT03571672|141745146|OTHER||Intra-class Correlation Coefficient|0.925|||||TWO_SIDED|95.0|0.897|0.945||||||Inter-reader Variability End Diastolic Echo Unenhanced||0.945|0.897|
71119702|NCT03571672|141745146|OTHER||Intra-class Correlation Coefficient|0.97|||||TWO_SIDED|95.0|0.958|0.978||||||Inter-reader Variability End Diastolic Echo Enhanced||0.978|0.958|
70854940|NCT02880956|141198368|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|4.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71080746|NCT02171429|141667868|SUPERIORITY||Mean Difference (Net)|-1.1||||0.1659|TWO_SIDED|95.0|-2.8|0.5||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||0.5|-2.8|0.1659
71080747|NCT02171429|141667868|SUPERIORITY||Mean Difference (Net)|0.1||||0.9182|TWO_SIDED|95.0|-1.3|1.4||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||1.4|-1.3|0.9182
71119703|NCT03571672|141745146|OTHER||Intra-class Correlation Coefficient|0.909|||||TWO_SIDED|95.0|0.876|0.934||||||Inter-reader Variability End Diastolic Echo Unenhanced||0.934|0.876|
71119704|NCT03571672|141745146|OTHER||Intra-class Correlation Coefficient|0.989|||||TWO_SIDED|95.0|0.984|0.992||||||Inter-reader Variability End Systolic Echo Enhanced||0.992|0.984|
71119705|NCT03571672|141745146|OTHER||Intra-class Correlation Coefficient|0.985|||||TWO_SIDED|95.0|0.979|0.989||||||Inter-reader Variability End Systolic Echo Unenhanced||0.989|0.979|
71119706|NCT03571672|141745146|OTHER||Intra-class Correlation Coefficient|0.973|||||TWO_SIDED|95.0|0.962|0.98||||||Inter-reader Variability End Systolic Echo Enhanced||0.980|0.962|
71119707|NCT03571672|141745146|OTHER||Intra-class Correlation Coefficient|0.947|||||TWO_SIDED|95.0|0.927|0.961||||||Inter-reader Variability End Systolic Echo Unenhanced||0.961|0.927|
71119708|NCT03571672|141745146|OTHER||Intra-class Correlation Coefficient|0.977|||||TWO_SIDED|95.0|0.969|0.984||||||Inter-reader Variability End Systolic Echo Enhanced||0.984|0.969|
71119709|NCT03571672|141745146|OTHER||Intra-class Correlation Coefficient|0.937|||||TWO_SIDED|95.0|0.914|0.954||||||Inter-reader Variability End Systolic Echo Unenhanced||0.954|0.914|
71119710|NCT03571672|141745147|OTHER||Intra-class Correlation Coefficient|0.945|||||TWO_SIDED|95.0|0.909|0.967||||||Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms||0.967|0.909|
71119711|NCT03571672|141745147|OTHER||Intra-class Correlation Coefficient|0.917|||||TWO_SIDED|95.0|0.864|0.95||||||Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms||0.950|0.864|
71119712|NCT03571672|141745147|OTHER||Intra-class Correlation Coefficient|0.939|||||TWO_SIDED|95.0|0.9|0.963||||||Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms||0.963|0.900|
71119713|NCT03571672|141745147|OTHER||Intra-class Correlation Coefficient|0.894|||||TWO_SIDED|95.0|0.827|0.935||||||Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms||0.935|0.827|
71119714|NCT03571672|141745147|OTHER||Intra-class Correlation Coefficient|0.952|||||TWO_SIDED|95.0|0.92|0.971||||||Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms||0.971|0.920|
71119715|NCT03571672|141745147|OTHER||Intra-class Correlation Coefficient|0.9|||||TWO_SIDED|95.0|0.838|0.939||||||Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms||0.939|0.838|
71119716|NCT03571672|141745148|OTHER||Intra-class Correlation Coefficient|0.976|||||TWO_SIDED|95.0|0.961|0.986||||||Inter-reader Variability End Diastolic Echo Enhanced||0.986|0.961|
71119717|NCT03571672|141745148|OTHER||Intra-class Correlation Coefficient|0.984|||||TWO_SIDED|95.0|0.974|0.991||||||Inter-reader Variability End Diastolic Echo Unenhanced||0.991|0.974|
71119718|NCT03571672|141745148|OTHER||Intra-class Correlation Coefficient|0.933|||||TWO_SIDED|95.0|0.89|0.96||||||Inter-reader Variability End Diastolic Echo Enhanced||0.960|0.890|
71119719|NCT03571672|141745148|OTHER||Intra-class Correlation Coefficient|0.857|||||TWO_SIDED|95.0|0.77|0.912||||||Inter-reader Variability End Diastolic Echo Unenhanced||0.912|0.770|
71119720|NCT03571672|141745148|OTHER||Intra-class Correlation Coefficient|0.948|||||TWO_SIDED|95.0|0.914|0.969||||||Inter-reader Variability End Diastolic Echo Enhanced||0.969|0.914|
71119721|NCT03571672|141745148|OTHER||Intra-class Correlation Coefficient|0.824|||||TWO_SIDED|95.0|0.721|0.892||||||Inter-reader Variability End Diastolic Echo Unenhanced||0.892|0.721|
71119722|NCT03571672|141745148|OTHER||Intra-class Correlation Coefficient|0.982|||||TWO_SIDED|95.0|0.97|0.989||||||Inter-reader Variability End Systolic Echo Enhanced||0.989|0.970|
71119723|NCT03571672|141745148|OTHER||Intra-class Correlation Coefficient|0.974|||||TWO_SIDED|95.0|0.957|0.985||||||Inter-reader Variability End Systolic Echo Unenhanced||0.985|0.957|
71119724|NCT03571672|141745148|OTHER||Intra-class Correlation Coefficient|0.948|||||TWO_SIDED|95.0|0.915|0.969||||||Inter-reader Variability End Systolic Echo Enhanced||0.969|0.915|
71119725|NCT03571672|141745148|OTHER||Intra-class Correlation Coefficient|0.89|||||TWO_SIDED|95.0|0.822|0.933||||||Inter-reader Variability End Systolic Echo Unenhanced||0.933|0.822|
71119726|NCT03571672|141745148|OTHER||Intra-class Correlation Coefficient|0.959|||||TWO_SIDED|95.0|0.932|0.975||||||Inter-reader Variability End Systolic Echo Enhanced||0.975|0.932|
71119727|NCT03571672|141745148|OTHER||Intra-class Correlation Coefficient|0.872|||||TWO_SIDED|95.0|0.794|0.922||||||Inter-reader Variability End Systolic Echo Unenhanced||0.922|0.794|
71119728|NCT00303446|141745149|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||Generalized estimating equation model|The analysis includes percent change from baseline at 12 and 24 months.||||||0.28
71119729|NCT00303446|141745150|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.86
71119730|NCT00303446|141745151|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||Comparison of changes from baseline in manual muscle testing results.||||0.47
71119731|NCT00303446|141745152|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.13
71119732|NCT00303446|141745153|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.46
70943614|NCT01040403|141387592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.157|STANDARD_ERROR_OF_MEAN|4.173|||TWO_SIDED|95.0|16.962|33.351|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-3h||33.351|16.962|
70943615|NCT01040403|141387592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.804|STANDARD_ERROR_OF_MEAN|4.216|||TWO_SIDED|95.0|21.526|38.082|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-3h||38.082|21.526|
70943616|NCT01040403|141387592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.398|STANDARD_ERROR_OF_MEAN|4.173|||TWO_SIDED|95.0|-1.796|14.592|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-3h||14.592|-1.796|
70943617|NCT01040403|141387592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.046|STANDARD_ERROR_OF_MEAN|4.239|||TWO_SIDED|95.0|2.721|19.37|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-3h||19.370|2.721|
70943618|NCT01040403|141387592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.648|STANDARD_ERROR_OF_MEAN|4.204|||TWO_SIDED|95.0|-3.608|12.903|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-3h||12.903|-3.608|
70943619|NCT01040403|141387592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.318|STANDARD_ERROR_OF_MEAN|4.201|||TWO_SIDED|95.0|10.068|26.568|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-3h||26.568|10.068|
70943620|NCT01040403|141387592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.511|STANDARD_ERROR_OF_MEAN|4.197|||TWO_SIDED|95.0|15.27|31.752|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-3h||31.752|15.270|
70943621|NCT01040403|141387592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.817|STANDARD_ERROR_OF_MEAN|4.214|||TWO_SIDED|95.0|14.543|31.092|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-3h||31.092|14.543|
70943622|NCT01040403|141387592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.193|STANDARD_ERROR_OF_MEAN|4.23|||TWO_SIDED|95.0|-3.115|13.5|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-3h||13.500|-3.115|
70943623|NCT01040403|141387592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.499|STANDARD_ERROR_OF_MEAN|4.185|||TWO_SIDED|95.0|-3.719|12.717|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-3h||12.717|-3.719|
70943624|NCT01040403|141387592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.694|STANDARD_ERROR_OF_MEAN|4.2|||TWO_SIDED|95.0|-8.941|7.554|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-3h||7.554|-8.941|
71080748|NCT02171429|141667869|SUPERIORITY||Mean Difference (Net)|-1.0||||1|TWO_SIDED|95.0|-2.1|0.2||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 4 of the testing procedure; please refer to the statistical analysis plan for details.||0.2|-2.1|1
71080749|NCT02171429|141667869|SUPERIORITY||Mean Difference (Net)|-0.3||||1|TWO_SIDED|95.0|-1.2|0.7||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 6 of the testing procedure; please refer to the statistical analysis plan for details.||0.7|-1.2|1
71119733|NCT00303446|141745154|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.11
70943625|NCT01040403|141387592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.751|STANDARD_ERROR_OF_MEAN|4.013|||TWO_SIDED|95.0|10.87|26.632|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-6h||26.632|10.870|
70943626|NCT01040403|141387592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.009|STANDARD_ERROR_OF_MEAN|3.998|||TWO_SIDED|95.0|18.158|33.86|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-6h||33.860|18.158|
70943627|NCT01040403|141387592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.347|STANDARD_ERROR_OF_MEAN|4.039|||TWO_SIDED|95.0|21.416|37.278|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-6h||37.278|21.416|
70943628|NCT01040403|141387592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.259|STANDARD_ERROR_OF_MEAN|3.998|||TWO_SIDED|95.0|-0.592|15.109|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-6h||15.109|-0.592|
70943629|NCT01040403|141387592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.596|STANDARD_ERROR_OF_MEAN|4.061|||TWO_SIDED|95.0|2.621|18.571|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-6h||18.571|2.621|
70943630|NCT01040403|141387592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.337|STANDARD_ERROR_OF_MEAN|4.028|||TWO_SIDED|95.0|-4.572|11.247|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-6h||11.247|-4.572|
70943631|NCT01040403|141387592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.654|STANDARD_ERROR_OF_MEAN|4.025|||TWO_SIDED|95.0|11.75|27.558|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-6h||27.558|11.750|
70943632|NCT01040403|141387592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.762|STANDARD_ERROR_OF_MEAN|4.021|||TWO_SIDED|95.0|14.866|30.659|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-6h||30.659|14.866|
70943633|NCT01040403|141387592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.536|STANDARD_ERROR_OF_MEAN|4.038|||TWO_SIDED|95.0|17.607|33.464|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-6h||33.464|17.607|
70943634|NCT01040403|141387592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.108|STANDARD_ERROR_OF_MEAN|4.053|||TWO_SIDED|95.0|-4.852|11.067|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-6h||11.067|-4.852|
70943635|NCT01040403|141387592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.881|STANDARD_ERROR_OF_MEAN|4.009|||TWO_SIDED|95.0|-1.991|13.754|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-6h||13.754|-1.991|
71119734|NCT00303446|141745155|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.08
71119735|NCT00303446|141745156|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.73
71080750|NCT02171429|141667870|SUPERIORITY||Mean Difference (Net)|-1.0||||0.0116|TWO_SIDED|95.0|-1.7|-0.2||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||-0.2|-1.7|0.0116
71080751|NCT02171429|141667870|SUPERIORITY||Mean Difference (Net)|-0.1||||0.6771|TWO_SIDED|95.0|-0.8|0.5||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||0.5|-0.8|0.6771
71080752|NCT02171429|141667871|SUPERIORITY||Mean Difference (Net)|-0.5||||1|TWO_SIDED|95.0|-1.0|0.0||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 4 of the testing procedure; please refer to the statistical analysis plan for details.||0.0|-1.0|1
71080753|NCT02171429|141667871|SUPERIORITY||Mean Difference (Net)|-0.3||||1|TWO_SIDED|95.0|-0.7|0.1||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 6 of the testing procedure; please refer to the statistical analysis plan for details.||0.1|-0.7|1
71080754|NCT02171429|141667872|SUPERIORITY||Difference in Remission Rates|7.9||||0.1382|TWO_SIDED|95.0|-3.19|16.87||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||16.87|-3.19|0.1382
71080755|NCT02171429|141667872|SUPERIORITY||Difference in Remission Rates|-7.5||||0.1163|TWO_SIDED|95.0|-17.1|2.22||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||2.22|-17.10|0.1163
71080756|NCT02171429|141667873|SUPERIORITY||Difference in Remission Rates|2.9||||0.4772|TWO_SIDED|95.0|-6.47|10.14||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||10.14|-6.47|0.4772
71119736|NCT00303446|141745157|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.37
71119737|NCT00303446|141745158|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.65
71119738|NCT00303446|141745159|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.99
71119739|NCT00303446|141745160|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||1.0
71119740|NCT00303446|141745161|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.014
71119741|NCT00303446|141745162|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||Generalized estimating equation model showed a significant interaction between time and treatment; therefore a two sample t-test was used at each time point. P-value is given for comparison at 24 months.|t-test, 2 sided|||||||0.033
70943636|NCT01040403|141387592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.773|STANDARD_ERROR_OF_MEAN|4.024|||TWO_SIDED|95.0|-5.129|10.675|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-6h||10.675|-5.129|
71080757|NCT02171429|141667873|SUPERIORITY||Difference in Remission Rates|-5.2||||0.1801|TWO_SIDED|95.0|-12.95|2.63||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||2.63|-12.95|0.1801
70943637|NCT01040403|141387593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.316|STANDARD_ERROR_OF_MEAN|4.371|||TWO_SIDED|95.0|-6.268|10.9|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||10.900|-6.268|
71080758|NCT02171429|141667874|SUPERIORITY||Difference in Adjusted Means|4.0||||0.4833|TWO_SIDED|95.0|-7.2|15.2||Nominal p-value; it has not been adjusted for multiplicity.|ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and IBDQ score at BL.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||15.2|-7.2|0.4833
71080759|NCT02171429|141667874|SUPERIORITY||Difference in Adjusted Means|0.0||||0.9931|TWO_SIDED|95.0|-9.2|9.1||Nominal p-value; it has not been adjusted for multiplicity.|ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and IBDQ score at BL.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||9.1|-9.2|0.9931
71080760|NCT01763203|141667880|SUPERIORITY|||||||0.73|||||||Mixed Models Analysis|||||||0.73
71080761|NCT01763203|141667881|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||||||0.77
71080762|NCT01763203|141667883|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||0.002
71080763|NCT01763203|141667884|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|||||||0.86
71080764|NCT01763203|141667885|SUPERIORITY|||||||0.1|||||||Mixed Models Analysis|||||||0.10
70943638|NCT01040403|141387593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.478|STANDARD_ERROR_OF_MEAN|4.362|||TWO_SIDED|95.0|-4.088|13.044|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||13.044|-4.088|
71080765|NCT01763203|141667886|SUPERIORITY|||||||0.46|||||||Mixed Models Analysis|||||||0.46
71080766|NCT01763203|141667887|SUPERIORITY|||||||0.011|||||||Mixed Models Analysis|||||||0.011
71080767|NCT01763203|141667888|SUPERIORITY|||||||0.47|||||||Mixed Models Analysis|||||||0.47
71080768|NCT01763203|141667889|SUPERIORITY|||||||0.58|||||||Mixed Models Analysis|||||||0.58
71080769|NCT01763203|141667890|SUPERIORITY|||||||0.74|||||||Mixed Models Analysis|||||||0.74
71080770|NCT01763203|141667891|SUPERIORITY|||||||0.0021|||||||Wilcoxon (Mann-Whitney)|||||||0.0021
71080771|NCT01763203|141667892|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|||||||0.07
71080772|NCT01763203|141667893|SUPERIORITY|||||||0.32|||||||Mixed Models Analysis|||||||0.32
71080773|NCT01763203|141667894|SUPERIORITY|||||||0.77|||||||Chi-squared|||||||0.77
71080774|NCT01763203|141667895|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
71080775|NCT01763203|141667896|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||0.45
71080776|NCT01763203|141667897|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||||||0.93
71080777|NCT01763203|141667898|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.80
71080778|NCT01763203|141667899|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||0.25
71080779|NCT02187861|141667900|SUPERIORITY_OR_OTHER||Difference in response rates|3.92|||||TWO_SIDED|95.0|-13.38|21.23||||||||21.23|-13.38|
71080780|NCT02187861|141667901|SUPERIORITY_OR_OTHER||Difference in response rates|1.96|||||TWO_SIDED|95.0|-15.89|19.81||||||||19.81|-15.89|
71080781|NCT02187861|141667902|SUPERIORITY_OR_OTHER||Difference in response rates|1.96|||||TWO_SIDED|95.0|-17.07|20.99||||||||20.99|-17.07|
71080782|NCT02187861|141667903|SUPERIORITY_OR_OTHER||Difference in response rates|-7.84|||||TWO_SIDED|95.0|-27.01|11.32||||||||11.32|-27.01|
71080783|NCT02187861|141667904|SUPERIORITY_OR_OTHER||Difference in response rates|13.73|||||TWO_SIDED|95.0|-4.24|31.69||||||At 6-8 weeks after Cycle 6 Day 1||31.69|-4.24|
71080784|NCT02187861|141667904|SUPERIORITY_OR_OTHER||Difference in response rates|3.92|||||TWO_SIDED|95.0|-12.98|20.82||||||At Year 1||20.82|-12.98|
71080785|NCT02187861|141667905|SUPERIORITY_OR_OTHER||Difference in response rates|-15.69|||||TWO_SIDED|95.0|-31.87|0.49||||||At 4-10 weeks after Cycle 6 Day 1||0.49|-31.87|
71080786|NCT02187861|141667905|SUPERIORITY_OR_OTHER||Difference in response rates|-7.84|||||TWO_SIDED|95.0|-22.56|6.87||||||At Year 1||6.87|-22.56|
71080787|NCT02187861|141667911|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.38|1.27|||||HR was calculated using Cox regression.|Stratified Analysis: Strata were disease burden and DOR of prior cancer therapy.||1.27|0.38|
71080788|NCT02187861|141667911|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.43|1.4|||||HR was calculated using Cox regression.|Unstratified Analysis||1.40|0.43|
71080789|NCT02187861|141667913|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.38|1.24|||||HR was calculated using Cox regression.|Stratified Analysis: Strata were disease burden and PFS of prior cancer therapy.||1.24|0.38|
71080790|NCT02187861|141667913|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.43|1.36|||||HR was calculated using Cox regression.|Unstratified Analysis||1.36|0.43|
71119742|NCT00303446|141745163|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.61
71119743|NCT00489736|141745168|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.59|||<|0.0001||95.0|1.28|1.98||Cumulative incidence functions in each treatment group were calculated using time-to-event non-parametric Kaplan-Meier estimate. The primary comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It provides the relative hazard of treatment failure for the dronedarone group compared with the amiodarone group.|||1.98|1.28|<0.0001
71119744|NCT00489736|141745169|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.13||95.0|0.6|1.07||Cumulative incidence functions in each treatment group were calculated using time-to-event non-parametric Kaplan-Meier estimate. The comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It provides the relative hazard of main safety event occurrence for the dronedarone group compared with the amiodarone group.|||1.07|0.60|0.13
71119745|NCT00489736|141745170|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.002||95.0|0.44|0.84||Cumulative incidence functions in each treatment group were calculated using time-to-event non-parametric Kaplan-Meier estimate. The comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It provides the relative hazard of MSE occurrence excluding gastrointestinal events, for the dronedarone group compared with the amiodarone group.|||0.84|0.44|0.002
71119746|NCT04035564|141745171|SUPERIORITY||Risk Ratio (RR)|0.2||||0.71|TWO_SIDED|95.0|0.026|1.533|||Chi-squared|||||1.533|0.026|0.71
71119747|NCT04035564|141745172|SUPERIORITY||Risk Ratio (RR)|1.21||||0.89|TWO_SIDED|95.0|0.081|18.09|||Chi-squared|||||18.09|0.081|0.89
71119748|NCT04035564|141745173|SUPERIORITY||Mean Difference (Final Values)|-2.861|STANDARD_ERROR_OF_MEAN|1.286||0.032|TWO_SIDED|95.0|-5.461|-0.261|||t-test, 2 sided|||||-0.261|-5.461|0.032
71119749|NCT04035564|141745173|SUPERIORITY||Mean Difference (Final Values)|-2.86|STANDARD_ERROR_OF_MEAN|1.286||0.032|TWO_SIDED|95.0|-5.461|-0.261|||ANOVA|||||-0.261|-5.461|0.032
71119750|NCT04035564|141745174|SUPERIORITY||Mean Difference (Final Values)|-3.788|STANDARD_ERROR_OF_MEAN|2.299||0.107|TWO_SIDED|95.0|-8.43|0.858|||t-test, 2 sided|||||0.858|-8.43|0.107
71119751|NCT04035564|141745174|SUPERIORITY||Mean Difference (Final Values)|-3.78|STANDARD_ERROR_OF_MEAN|2.299||0.107|TWO_SIDED|95.0|-8.43|0.85|||ANOVA|||||0.85|-8.43|0.107
71119752|NCT04035564|141745175|SUPERIORITY||Mean Difference (Final Values)|-39.38|STANDARD_ERROR_OF_MEAN|17.22||0.028|TWO_SIDED|95.0|-74.18|-4.57|||t-test, 2 sided|||||-4.57|-74.18|0.028
71119753|NCT04035564|141745175|SUPERIORITY||Mean Difference (Final Values)|-39.38|STANDARD_ERROR_OF_MEAN|17.22||0.028|TWO_SIDED|95.0|-74.18|-4.57|||ANOVA|||||-4.57|-74.18|0.028
71119754|NCT04035564|141745176|SUPERIORITY||Risk Ratio (RR)|0.75||||0.55|TWO_SIDED|95.0|0.296|1.932|||Chi-squared|||||1.932|0.296|0.55
71119755|NCT04035564|141745177|SUPERIORITY||Risk Ratio (RR)|1.09||||0.84|TWO_SIDED|95.0|0.169|7.096|||Chi-squared|||||7.096|0.169|0.84
71119756|NCT04035564|141745178|SUPERIORITY||Risk Ratio (RR)|0.8||||0.7|TWO_SIDED|95.0|0.266|2.448|||Chi-squared|||||2.448|0.266|0.70
71119757|NCT04035564|141745179|SUPERIORITY|||||||0.33|||||||Chi-squared|||||||0.33
71119758|NCT04035564|141745179|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.57|TWO_SIDED||||||Regression, Cox|||||||0.57
71119759|NCT01774097|141745192|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|0.8||0.238|TWO_SIDED|95.0|-0.6|2.5||Threshold 0.05; no adjustment for multiple comparisons per protocol.|t-test, 2 sided|||||2.5|-0.6|0.238
71119760|NCT01774097|141745193|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|0.6||0.116|TWO_SIDED|95.0|-0.2|2.1||Threshold 0.05; no adjustment for multiple comparisons per protocol.|t-test, 2 sided|||||2.1|-0.2|0.116
71119761|NCT01774097|141745194|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.4||0.978|TWO_SIDED|95.0|-0.8|0.8||Threshold 0.05; no adjustment for multiple comparisons per protocol.|t-test, 2 sided|||||0.8|-0.8|0.978
71119762|NCT01774097|141745195|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.55||0.752|TWO_SIDED|95.0|-1.26|0.91||Threshold 0.05; no adjustment for multiple comparisons per protocol.|t-test, 2 sided|||||0.91|-1.26|0.752
71119763|NCT01774097|141745196|SUPERIORITY_OR_OTHER||interaction term|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.871|TWO_SIDED|95.0|-0.02|0.03||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear|||||0.03|-0.02|0.871
71119764|NCT01774097|141745197|SUPERIORITY_OR_OTHER||interaction term|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.256|TWO_SIDED|95.0|-0.06|0.02||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear|||||0.02|-0.06|0.256
71119765|NCT01774097|141745198|SUPERIORITY_OR_OTHER||interaction term|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.241|TWO_SIDED|95.0|-0.2|0.6|||Regression, Linear|||||0.6|-0.2|0.241
71119766|NCT01774097|141745200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.1|STANDARD_ERROR_OF_MEAN|1.4||0.131|TWO_SIDED|95.0|-0.6|4.8||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear|||||4.8|-0.6|0.131
71119767|NCT01774097|141745201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|1.7||0.626|TWO_SIDED|95.0|-2.6|4.2||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear|||||4.2|-2.6|0.626
71119768|NCT01774097|141745202|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|1.6||0.591|TWO_SIDED|95.0|-4.1|2.3||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear|||||2.3|-4.1|0.591
71119769|NCT01774097|141745203|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|2.0||0.722|TWO_SIDED|95.0|-3.3|4.7||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear|||||4.7|-3.3|0.722
71119770|NCT03664674|141745206|SUPERIORITY||Mean Difference (Net)|-0.221|STANDARD_ERROR_OF_MEAN|0.218||0.312|TWO_SIDED|95.0|-0.648|0.207||Generalized Linear Model - Negative Binomial Regression Model with count data by subject transformed using the log-link function.|Regression, Linear|The parameter estimate + conf. int. results back-transform to the ratio of adjusted mean DVDs (OTO-104/Placebo) to be 0.802 (0.523, 1.230).||||0.207|-0.648|0.312
70943639|NCT01040403|141387593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.668|STANDARD_ERROR_OF_MEAN|4.403|||TWO_SIDED|95.0|-3.978|13.314|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||13.314|-3.978|
71119771|NCT04762043|141745256|SUPERIORITY||Mean Difference (Final Values)|56.55|STANDARD_ERROR_OF_MEAN|1.64|<|0.001|TWO_SIDED|95.0|53.33|59.76|||Mixed Models Analysis|Effect size used for mixed effects model is partial eta-squared (ηp2).||||59.76|53.33|<.001
71119772|NCT00090233|141745257|NON_INFERIORITY_OR_EQUIVALENCE|Relative Risk ≤10.0 (non-inferiority margin).|relative risk|1.6||||0.006||95.0|0.4|6.4||"p≤ 10/11, where p is proportion of participants with intussusception in vaccine group relative to total number of participants with intussusception. Based on conditional binomial approach.~Adjusted for group-sequential design."|Exact binomial test|Exact binomial test adjusted for group-sequential design.||||6.4|0.4|0.006
71119773|NCT00090233|141745258|SUPERIORITY_OR_OTHER||Proportion|81.2|||<|0.001||95.0|72.9|87.8||p≥42%, where p is proportion of participants with ≥3-fold rise in antibody titer from Predose 1 to Postdose 3 in vaccine group. Based on binomial approach.|Exact binomial test|||||87.8|72.9|<0.001
71119774|NCT00090233|141745259|SUPERIORITY_OR_OTHER||Efficacy=1-Relative Risk|74.0|||<|0.001||95.0|66.8|79.9||"Efficacy≥35%. Based on p≤.65/(.65+k), where p is proportion of participants with outcome in vaccine group relative to total number of participants with outcome, k is ratio of follow-up time; placebo/vaccine.~Based on conditional binomial approach."|Exact binomial test|Exact binomial test.|Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group.|||79.9|66.8|<0.001
71119775|NCT00090233|141745260|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|94.5|||<|0.001||95.0|91.2|96.6||Rate Reduction\>0%|Poisson regression|"Poisson regression with generalized estimating equations.~Validated with Van Elteren's extension of Wilcoxon Rank Sum test."|Risk ratio of rate of hospitalizations and emergency department visits between treatment groups. Reported here are results after 12 additional emergency department visits were identified among placebo recipients and data were re-analyzed.|||96.6|91.2|<0.001
71119776|NCT00090233|141745261|SUPERIORITY_OR_OTHER||Efficacy=1-Relative Risk|81.5|||<|0.001||95.0|74.9|86.7||Efficacy\>0%. Based on p\< 1/(1+k), where p is proportion of participants with outcome in vaccine group relative to total number of participants with outcome, and k is ratio of follow-up time; placebo / vaccine. Based on conditional binomial approach.|Exact binomial test||Estimated value is based on the worst episode scores.|||86.7|74.9|<0.001
71119777|NCT00090233|141745262|SUPERIORITY_OR_OTHER||Efficacy=1-Relative Risk|98.0|||<|0.001||95.0|88.3|100.0||Efficacy\>0%. Based on p\< 1/(1+k), where p is proportion of participants with outcome in vaccine group relative to total number of participants with outcome, and k is ratio of follow-up time; placebo/vaccine. Based on conditional binomial approach.|Exact binomial test|||||100|88.3|<0.001
71119778|NCT00090233|141745263|NON_INFERIORITY_OR_EQUIVALENCE|Difference (vaccine-placebo) in seroprotection rates was greater than -.10 (non-inferiority margin).|||||<|0.001||95.0||||p\<0.001 was obtained for all comparisons. pv - pp ≥-.10, where p is proportion of participants who achieved seroprotection in the vaccine and placebo groups, respectively.|Miettenen and Nurminen|||||||<0.001
70943640|NCT01040403|141387593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.162|STANDARD_ERROR_OF_MEAN|4.349|||TWO_SIDED|95.0|-6.379|10.702|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||10.702|-6.379|
71119779|NCT00090233|141745264|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for Pertussis PT|0.9|||<|0.001|TWO_SIDED|95.0|0.7|1.1|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for Pertussis PT was used for analysis.||1.1|0.7|<0.001
71119780|NCT00090233|141745264|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for Pertussis FHA|0.9|||<|0.001|TWO_SIDED|95.0|0.7|1.1|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for Pertussis FHA was used for analysis.||1.1|0.7|<0.001
71119781|NCT00090233|141745264|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for Pertussis Pertactin|0.6||||0.193|TWO_SIDED|95.0|0.4|0.8|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for Pertussis Pertactin was used for analysis.||0.8|0.4|0.193
71119782|NCT00090233|141745265|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 4|1.2|||<|0.001||95.0|1.0|1.4|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 4 was used for analysis.||1.4|1.0|<0.001
71119783|NCT00090233|141745265|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 6B|1.4|||<|0.001|TWO_SIDED|95.0|1.0|1.9|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 6B was used for analysis.||1.9|1.0|<0.001
71119784|NCT00090233|141745265|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 9V|1.1|||<|0.001|TWO_SIDED|95.0|0.9|1.3|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 9V was used for analysis.||1.3|0.9|<0.001
71119785|NCT00090233|141745265|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 14|1.0|||<|0.001|TWO_SIDED|95.0|0.7|1.3|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 14 was used for analysis.||1.3|0.7|<0.001
71119786|NCT00090233|141745265|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 18C|1.3|||<|0.001|TWO_SIDED|95.0|1.1|1.6|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 18C was used for analysis.||1.6|1.1|<0.001
71119787|NCT00090233|141745265|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 19F|1.1|||<|0.001|TWO_SIDED|95.0|0.8|1.4|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 19F was used for analysis.||1.4|0.8|<0.001
71119788|NCT00090233|141745265|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 23F|1.1|||<|0.001|TWO_SIDED|95.0|0.9|1.5|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 23F was used for analysis.||1.5|0.9|<0.001
71119789|NCT01057225|141745307|SUPERIORITY_OR_OTHER||Dose Level|1.0|||||TWO_SIDED||||||||Using a cohort of 3 design, it was determined the maximum tolerated dose of carfilzomib is Dose Level 1: 20 mg/m\^2 for the first cycle and 36 mg/m\^2 for subsequent cycles.|||||
71119790|NCT04600505|141745347|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|111.7|||||TWO_SIDED|90.0|91.01|137.1||||||Statistical Comparison of Budesonide PK Parameters for Treatment A (test) versus Treatment C (reference)||137.1|91.01|
71119791|NCT04600505|141745347|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|98.78|||||TWO_SIDED|90.0|78.67|124.0||||||Statistical Comparison of Budesonide PK Parameters for Treatment B (test) versus Treatment C (reference)||124.0|78.67|
71119792|NCT04600505|141745347|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|108.3|||||TWO_SIDED|90.0|85.5|137.3||||||Statistical Comparison of Glycopyrronium PK Parameters for Treatment A (test) versus Treatment C (reference)||137.3|85.50|
71119793|NCT04600505|141745347|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|94.88|||||TWO_SIDED|90.0|74.69|120.5||||||Statistical Comparison of Glycopyrronium PK Parameters for Treatment B (test) versus Treatment C (reference)||120.5|74.69|
71119794|NCT04600505|141745347|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|109.1|||||TWO_SIDED|90.0|97.02|122.7||||||Statistical Comparison of Formoterol PK Parameters for Treatment A (test) versus Treatment C (reference)||122.7|97.02|
71119795|NCT04600505|141745347|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|100.1||||||90.0|83.78|119.5||||||Statistical Comparison of Formoterol PK Parameters for Treatment B (test) versus Treatment C (reference)||119.5|83.78|
71119796|NCT04600505|141745348|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|104.7|||||TWO_SIDED|90.0|91.95|119.2||||||Statistical Comparison of Budesonide PK Parameters for Treatment A (test) versus Treatment C (reference)||119.2|91.95|
71119797|NCT04600505|141745348|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|98.03|||||TWO_SIDED|90.0|83.33|115.3||||||Statistical Comparison of Budesonide PK Parameters for Treatment B (test) versus Treatment C (reference)||115.3|83.33|
71119798|NCT04600505|141745348|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|96.0||||||90.0|70.33|131.0||||||Statistical Comparison of Formoterol PK Parameters for Treatment A (test) versus Treatment C (reference)||131.0|70.33|
71119799|NCT04600505|141745348|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|116.7||||||90.0|86.31|157.8||||||Statistical Comparison of Formoterol PK Parameters for Treatment B (test) versus Treatment C (reference)||157.8|86.31|
71119800|NCT04600505|141745349|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|107.3|||||TWO_SIDED|90.0|94.53|121.9||||||Statistical Comparison of Budesonide PK Parameters for Treatment A (test) versus Treatment C (reference)||121.9|94.53|
71119801|NCT04600505|141745349|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|98.8|||||TWO_SIDED|90.0|84.59|115.4||||||Statistical Comparison of Budesonide PK Parameters for Treatment B (test) versus Treatment C (reference)||115.4|84.59|
71119802|NCT04600505|141745349|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|106.1|||||TWO_SIDED|90.0|86.18|130.6||||||Statistical Comparison of Glycopyrronium PK Parameters for Treatment A (test) versus Treatment C (reference)||130.6|86.18|
70943641|NCT01040403|141387593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.352|STANDARD_ERROR_OF_MEAN|4.419|||TWO_SIDED|95.0|-6.326|11.029|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||11.029|-6.326|
71080791|NCT02187861|141667915|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.38|1.24|||||HR was calculated using Cox regression.|Stratified Analysis: Strata were disease burden and EFS of prior cancer therapy.||1.24|0.38|
71080792|NCT02187861|141667915|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.43|1.36|||||HR was calculated using Cox regression.|Unstratified Analysis||1.36|0.43|
71080793|NCT02187861|141667917|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.48|||||TWO_SIDED|95.0|0.04|5.37|||||HR was calculated using Cox regression.|Stratified Analysis: Strata were disease burden and OS of prior cancer therapy.||5.37|0.04|
71080794|NCT02187861|141667917|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.05|5.63|||||HR was calculated using Cox regression.|Unstratified Analysis||5.63|0.05|
71080795|NCT04957212|141667927|EQUIVALENCE|We used an equivalence margin of 0.2 for the primary endpoint.|Risk Difference (RD)|-0.04||||0.54|TWO_SIDED|95.0|-0.16|0.09|||Chi-squared|||||0.09|-0.16|0.54
71080796|NCT04957212|141667928|OTHER||Risk Difference (RD)|-0.07||||0.26|TWO_SIDED|95.0|-0.21|0.06|||Chi-squared|||||0.06|-0.21|0.26
71080797|NCT04957212|141667929|OTHER|||||||0.99|||||||Fisher Exact|||||||0.99
71119803|NCT04600505|141745349|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|99.71|||||TWO_SIDED|90.0|80.84|123.0||||||Statistical Comparison of Glycopyrronium PK Parameters for Treatment B (test) versus Treatment C (reference)||123.0|80.84|
71080798|NCT04957212|141667930|OTHER|||||||0.56|||||||Chi-squared|||||||0.56
71080799|NCT01768559|141667954|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified non-inferiority margin of 0.4%.|Least Square (LS) Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.059|||TWO_SIDED|95.0|-0.17|0.064|||ANCOVA||Lixisenatide vs Insulin Glulisine QD|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of metformin use, and country as fixed effects and baseline HbA1c value as a covariate. The non-inferiority was assessed using upper bound of 2-sided 95% Confidence Interval (CI).||0.064|-0.17|
71080800|NCT01768559|141667954|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified non-inferiority margin of 0.4%.|LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.059|||TWO_SIDED|95.0|0.095|0.328|||ANCOVA||Lixisenatide vs Insulin Glulisine TID|Analysis was performed using ANCOVA model as described above. Hochberg procedure was used to control type 1 error at significance level = 0.025 (1-sided) for comparison between Lixisenatide vs Insulin glulisine TID in HbA1c and body weight. If both comparisons were met, then both would be declared significant. Otherwise, if only one was met, then the one met should be tested at α=0.0125 (1-sided).||0.328|0.095|
71080801|NCT01768559|141667955|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.99|STANDARD_ERROR_OF_MEAN|0.305|<|0.0001|TWO_SIDED|95.0|-2.593|-1.396||Threshold for significance at 0.025 level.|ANCOVA|The superiority was assessed by comparing the P-value at significance level = 0.025 or 0.0125.|Lixisenatide vs Insulin Glulisine TID|Analysis was performed using ANCOVA model as described above. Hochberg procedure was used to control type 1 error at α = 0.025 (1-sided) for comparison between lixisenatide vs insulin glulisine TID in HbA1c and body weight. If both comparisons were met, then both would be declared significant. Otherwise, if only one was met, then the one met should be tested at α=0.0125 (1-sided).||-1.396|-2.593|< 0.0001
71080802|NCT01188668|141667986|SUPERIORITY_OR_OTHER||ratio of adjusted means|105.97|||||TWO_SIDED|90.0|101.39|110.76|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Aripiprazole 5 mg (test) versus Aripiprazole 5 mg (reference)||110.76|101.39|
71080803|NCT01188668|141667987|SUPERIORITY_OR_OTHER||ratio of adjusted means|101.05|||||TWO_SIDED|90.0|92.94|109.87|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Aripiprazole 5 mg (test) versus Aripiprazole 5 mg (reference)||109.87|92.94|
71080804|NCT01188668|141667992|SUPERIORITY_OR_OTHER||ratio of adjusted means|102.93|||||TWO_SIDED|90.0|94.21|112.46|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Aripiprazole 5 mg (test) versus Aripiprazole 5 mg (reference)||112.46|94.21|
71080805|NCT01188668|141667993|SUPERIORITY_OR_OTHER||ratio of adjusted means|106.27|||||TWO_SIDED|90.0|100.97|111.85|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Aripiprazole 5 mg (test) versus Aripiprazole 5 mg (reference)||111.85|100.97|
71080806|NCT02081001|141668019|SUPERIORITY_OR_OTHER||Point estimate ratio|2.06|STANDARD_ERROR_OF_MEAN|1.19||0.23|TWO_SIDED|90.0|0.74|5.75|||Mixed Models Analysis|||||5.75|0.74|0.23
71080807|NCT02081001|141668019|SUPERIORITY_OR_OTHER||Point estimate ratio|1.25|STANDARD_ERROR_OF_MEAN|0.43||0.52|TWO_SIDED|90.0|0.69|2.28|||Mixed Models Analysis|||||2.28|0.69|0.52
71080808|NCT02081001|141668019|SUPERIORITY_OR_OTHER||Point estimate ratio|0.86|STANDARD_ERROR_OF_MEAN|0.19||0.49|TWO_SIDED|90.0|0.59|1.25|||Mixed Models Analysis|||||1.25|0.59|0.49
71080809|NCT02081001|141668020|SUPERIORITY_OR_OTHER||Point estimate ratio|1.37|STANDARD_ERROR_OF_MEAN|0.34||0.23|TWO_SIDED|90.0|0.88|2.12|||Mixed Models Analysis|||||2.12|0.88|0.23
71080810|NCT02081001|141668020|SUPERIORITY_OR_OTHER||Point estimate ratio|1.29|STANDARD_ERROR_OF_MEAN|0.18||0.09|TWO_SIDED|90.0|1.01|1.65|||Mixed Models Analysis|||||1.65|1.01|0.09
71080811|NCT02081001|141668020|SUPERIORITY_OR_OTHER||Point estimate ratio|1.36|STANDARD_ERROR_OF_MEAN|0.16||0.02|TWO_SIDED|90.0|1.11|1.67|||Mixed Models Analysis|||||1.67|1.11|0.02
71119804|NCT04600505|141745349|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|98.13|||||TWO_SIDED|90.0|86.44|111.4||||||Statistical Comparison of Formoterol PK Parameters for Treatment A (test) versus Treatment C (reference)||111.4|86.44|
71119805|NCT04600505|141745349|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|107.0|||||TWO_SIDED|90.0|88.82|128.9||||||Statistical Comparison of Formoterol PK Parameters for Treatment B (test) versus Treatment C (reference)||128.9|88.82|
71119806|NCT04065074|141745373|OTHER|Proportion of Successful Administrations|Proportion of Successful Administrations|0.75|||||TWO_SIDED|90.0|0.51|0.9||||||||0.90|0.51|
71119807|NCT00871117|141745374|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% confidence interval (CI) for the between-group differences in booster response to diphtheria was greater than or equal to (≥)-10%.|Difference in booster response rates|0.01|||||TWO_SIDED|95.0|-2.54|2.58||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of diphtheria (D) booster response one month after vaccination with DTaP-IPV vaccine.||2.58|-2.54|
70943642|NCT01040403|141387593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|4.39|||TWO_SIDED|95.0|-8.43|8.81|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||8.810|-8.430|
71080812|NCT02081001|141668021|SUPERIORITY_OR_OTHER||Point estimate ratio|1.26|STANDARD_ERROR_OF_MEAN|0.19||0.15|TWO_SIDED|90.0|0.97|1.64|||Mixed Models Analysis|||||1.64|0.97|0.15
70854941|NCT02880956|141198368|SUPERIORITY||LS Mean of Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.682||0.066|TWO_SIDED|95.0|-2.602|0.081||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.081|-2.602|0.066
71080813|NCT02081001|141668021|SUPERIORITY_OR_OTHER||Point estimate ratio|1.29|STANDARD_ERROR_OF_MEAN|0.26||0.24|TWO_SIDED|90.0|0.9|1.84|||Mixed Models Analysis|||||1.84|0.90|0.24
71080814|NCT02081001|141668021|SUPERIORITY_OR_OTHER||Point estimate ratio|0.83|STANDARD_ERROR_OF_MEAN|0.15||0.31|TWO_SIDED|90.0|0.6|1.14|||Mixed Models Analysis|||||1.14|0.60|0.31
71080815|NCT02081001|141668022|SUPERIORITY_OR_OTHER||Point estimate ratio|1.18|STANDARD_ERROR_OF_MEAN|0.11||0.09|TWO_SIDED|90.0|1.01|1.39|||Mixed Models Analysis|||||1.39|1.01|0.09
71080816|NCT02081001|141668022|SUPERIORITY_OR_OTHER||Point estimate ratio|1.12|STANDARD_ERROR_OF_MEAN|0.12||0.29|TWO_SIDED|90.0|0.93|1.35|||Mixed Models Analysis|||||1.35|0.93|0.29
71080817|NCT02081001|141668022|SUPERIORITY_OR_OTHER||Point estimate ratio|1.11|STANDARD_ERROR_OF_MEAN|0.09||0.24|TWO_SIDED|90.0|0.96|1.28|||Mixed Models Analysis|||||1.28|0.96|0.24
71080818|NCT02081001|141668023|SUPERIORITY_OR_OTHER||Point estimate ratio|0.91|STANDARD_ERROR_OF_MEAN|0.22||0.7|TWO_SIDED|90.0|0.6|1.38|||Mixed Models Analysis|||||1.38|0.60|0.70
71080819|NCT02081001|141668023|SUPERIORITY_OR_OTHER||Point estimate ratio|1.26|STANDARD_ERROR_OF_MEAN|0.21||0.19|TWO_SIDED|90.0|0.94|1.68|||Mixed Models Analysis|||||1.68|0.94|0.19
70854942|NCT02880956|141198368|SUPERIORITY||Effect size/pooled SD|0.25|STANDARD_DEVIATION|5.08|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70943643|NCT01040403|141387593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.488|STANDARD_ERROR_OF_MEAN|4.392|||TWO_SIDED|95.0|-7.136|10.113|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||10.113|-7.136|
71080820|NCT02081001|141668023|SUPERIORITY_OR_OTHER||Point estmate ratio|1.45|STANDARD_ERROR_OF_MEAN|0.26||0.052|TWO_SIDED|90.0|1.07|1.98|||Mixed Models Analysis|||||1.98|1.07|0.052
71080821|NCT02081001|141668024|SUPERIORITY_OR_OTHER||Point estimate ratio|2.02|STANDARD_ERROR_OF_MEAN|0.95||0.16|TWO_SIDED|90.0|0.87|4.66|||Mixed Models Analysis|||||4.66|0.87|0.16
71080822|NCT02081001|141668024|SUPERIORITY_OR_OTHER||Point estimate ratio|1.31|STANDARD_ERROR_OF_MEAN|0.49||0.48|TWO_SIDED|90.0|0.68|2.54|||Mixed Models Analysis|||||2.54|0.68|0.48
71080823|NCT02081001|141668024|SUPERIORITY_OR_OTHER||Point estimate ratio|0.8|STANDARD_ERROR_OF_MEAN|0.16||0.28|TWO_SIDED|90.0|0.57|1.13|||Mixed Models Analysis|||||1.13|0.57|0.28
71080824|NCT02081001|141668025|SUPERIORITY_OR_OTHER||Point estimate ratio|1.06|STANDARD_ERROR_OF_MEAN|0.12||0.61|TWO_SIDED|90.0|0.87|1.3|||Mixed Models Analysis|||||1.30|0.87|0.61
71080825|NCT02081001|141668025|SUPERIORITY_OR_OTHER||Point estimate ratio|1.19|STANDARD_ERROR_OF_MEAN|0.16||0.22|TWO_SIDED|90.0|0.94|1.5|||Mixed Models Analysis|||||1.5|0.94|0.22
71080826|NCT02081001|141668025|SUPERIORITY_OR_OTHER||Point estimate ratio|0.84|STANDARD_ERROR_OF_MEAN|0.12||0.26|TWO_SIDED|90.0|0.66|1.09|||Mixed Models Analysis|||||1.09|0.66|0.26
71080827|NCT02081001|141668026|SUPERIORITY_OR_OTHER||Point estimate ratio|1.18|STANDARD_ERROR_OF_MEAN|0.14||0.19|TWO_SIDED|90.0|0.96|1.46|||Mixed Models Analysis|||||1.46|0.96|0.19
71080828|NCT02081001|141668026|SUPERIORITY_OR_OTHER||Point estimate ratio|1.15|STANDARD_ERROR_OF_MEAN|0.12||0.21|TWO_SIDED|90.0|0.95|1.38|||Regression, Cox|||||1.38|0.95|0.21
71080829|NCT02081001|141668026|SUPERIORITY_OR_OTHER||Point estimate ratio|1.13|STANDARD_ERROR_OF_MEAN|0.1||0.19|TWO_SIDED|90.0|0.97|1.31|||Mixed Models Analysis|||||1.31|0.97|0.19
71080830|NCT02081001|141668027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.4|STANDARD_ERROR_OF_MEAN|5.4||0.24|TWO_SIDED|95.0|-17.1|4.3|||Mixed Models Analysis|||||4.3|-17.1|0.24
71080831|NCT02081001|141668027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.4|STANDARD_ERROR_OF_MEAN|5.4||0.0005|TWO_SIDED|95.0|-30.1|-8.7|||Mixed Models Analysis|||||-8.7|-30.1|0.0005
71080832|NCT02081001|141668027|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.3|STANDARD_ERROR_OF_MEAN|5.4|<|0.0001|TWO_SIDED|95.0|-34.0|-12.6|||Mixed Models Analysis|||||-12.6|-34.0|<0.0001
71080833|NCT02081001|141668028|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|STANDARD_ERROR_OF_MEAN|1.6||0.22|TWO_SIDED|95.0|-5.1|1.2|||Mixed Models Analysis|||||1.2|-5.1|0.22
71080834|NCT02081001|141668028|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|1.6||0.58|TWO_SIDED|95.0|-4.0|2.3|||Mixed Models Analysis|||||2.3|-4.0|0.58
71080835|NCT02081001|141668028|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.6|STANDARD_ERROR_OF_MEAN|1.6||0.03|TWO_SIDED|95.0|-6.7|-0.4|||Mixed Models Analysis|||||-0.4|-6.7|0.03
71080836|NCT05816070|141668029|NON_INFERIORITY|The non-inferiority margin is -10% based on the general standard of antibacterial drug. Non-inferiority is established when P\<0.05.||||||0.0137|||||||Chi-squared|||||||0.0137
71080837|NCT03124537|141668044|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, and health||Tested whether weekly steps increased from the baseline week in both conditions (main effect of time).||||< .001
71080838|NCT03124537|141668044|SUPERIORITY|||||||0.846||||||Controlling for age, sex, education, and health.|Mixed Models Analysis|||Tested whether weekly step increases from the baseline week differed between the two conditions (time by condition interaction).||||.846
71080839|NCT03124537|141668045|SUPERIORITY|||||||0.571||||||Controlling for age, sex, condition, education, and health.|Mixed Models Analysis|||Tested whether exercise self-efficacy increased from the baseline week to the end of the intervention in both conditions (main effect of time).||||.571
71080840|NCT03124537|141668045|SUPERIORITY|||||||0.361|||||||Mixed Models Analysis|Controlling for age, sex, education, and health.||Tested whether exercise self efficacy increases from the baseline to the end of the intervention differed between the two conditions (time by condition interaction).||||.361
70943644|NCT01040403|141387593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.262|STANDARD_ERROR_OF_MEAN|4.386|||TWO_SIDED|95.0|-5.35|11.875|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||11.875|-5.350|
70943645|NCT01040403|141387593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.121|STANDARD_ERROR_OF_MEAN|4.408|||TWO_SIDED|95.0|-1.535|15.778|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||15.778|-1.535|
70943646|NCT01040403|141387593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.774|STANDARD_ERROR_OF_MEAN|4.423|||TWO_SIDED|95.0|-6.91|10.458|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||10.458|-6.910|
71080841|NCT03124537|141668046|SUPERIORITY|||||||0.564|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, and health.||Tested whether exercise control increased from the baseline week to the end of the intervention in both conditions (main effect of time).||||.564
71080842|NCT03124537|141668046|SUPERIORITY|||||||0.641|||||||Mixed Models Analysis|Controlling for age, sex, education, and health.||Tested whether exercise control belief increases from the baseline to the end of the intervention differed between the two conditions (time by condition interaction).||||.641
71080843|NCT03124537|141668048|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, health, and average steps.||Tested whether daily walking was related to mood within-persons.||||< .001
71080844|NCT03124537|141668048|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|Controlling for age, condition, education, health, and average steps.||Tested whether daily walking was related to energy within-persons.||||.003
70854943|NCT02880956|141198368|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.7||0.962|TWO_SIDED|95.0|-1.343|1.41||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||1.410|-1.343|0.962
70854944|NCT02880956|141198368|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|5.33|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71080845|NCT03124537|141668048|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, health, and average steps.||Tested whether the relationship between daily walking and mood differed between males and females (steps by sex interaction).||||< .001
71080846|NCT03124537|141668048|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Controlling for age, condition, education, health, and average steps.||Tested whether the relationship between daily walking and energy differed between males and females (steps by sex interaction).||||< .001
71119808|NCT00871117|141745374|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% CI for the between-group differences in booster response to tetanus was ≥ -10%.|Difference in booster response rates|0.98|||||TWO_SIDED|95.0|-1.99|4.26||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of tetanus (T) booster response one month after vaccination with DTaP-IPV vaccine.||4.26|-1.99|
70943647|NCT01040403|141387593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.663|STANDARD_ERROR_OF_MEAN|4.381|||TWO_SIDED|95.0|-2.97|14.236|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||14.236|-2.970|
70943648|NCT01040403|141387593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.859|STANDARD_ERROR_OF_MEAN|4.403|||TWO_SIDED|95.0|-4.786|12.504|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||12.504|-4.786|
70943649|NCT01040403|141387594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.682|STANDARD_ERROR_OF_MEAN|4.849|||TWO_SIDED|95.0|9.161|28.204|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||28.204|9.161|
71080847|NCT03124537|141668049|SUPERIORITY|||||||0.011|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, and health.||Tested whether self-reported vigorous physical activity increased from the baseline week to the end of the intervention in both conditions (main effect of time).||||.011
71080848|NCT03124537|141668049|SUPERIORITY|||||||0.232|||||||Mixed Models Analysis|Controlling for age, sex, education, and health.||Tested whether self-reported vigorous physical activity increases from the baseline to the end of the intervention differed between the two conditions (time by condition interaction).||||.232
71080849|NCT03124537|141668050|SUPERIORITY|||||||0.53|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, and health.||Tested whether self-reported moderate physical activity increased from the baseline week to the end of the intervention in both conditions (main effect of time).||||.530
71080850|NCT03124537|141668050|SUPERIORITY|||||||0.831|||||||Mixed Models Analysis|Controlling for age, sex, education, and health.||Tested whether self-reported moderate physical activity increases from the baseline to the end of the intervention differed between the two conditions (time by condition interaction).||||.831
71080851|NCT03124537|141668051|SUPERIORITY|||||||0.199|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, and health.||Tested whether self-reported light physical activity increased from the baseline week to the end of the intervention in both conditions (main effect of time).||||.199
71080852|NCT03124537|141668051|SUPERIORITY|||||||0.203|||||||Mixed Models Analysis|Controlling for age, sex, education, and health.||Tested whether self-reported light physical activity increases from the baseline to the end of the intervention differed between the two conditions (time by condition interaction).||||.203
71080853|NCT03681184|141668054|SUPERIORITY||Difference in Least Squares (LS) Mean|-53.546|STANDARD_ERROR_OF_MEAN|4.3224|<|0.0001|TWO_SIDED|95.0|-62.314|-44.778||P=1.685E-14|MMRM|||The Mixed-Effect Model Repeated Measures (MMRM) includes fixed effects of treatment arms (lumasiran vs. placebo) and scheduled visits (months 3, 4, 5, and 6), baseline 24-hour urinary oxalate corrected for BSA as a continuous fixed covariate, and patient as a random effect. The variance-covariance matrix is assumed to be unstructured. Satterthwaite approximation is used to estimate denominator degrees of freedom.||-44.778|-62.314|<0.0001
71080854|NCT03681184|141668055|SUPERIORITY||Difference in LS Mean|-0.975|STANDARD_ERROR_OF_MEAN|0.0998|<|0.0001|TWO_SIDED|95.0|-1.177|-0.772||P=1.225E-11|MMRM|||The MMRM includes fixed effects of treatment arms (lumasiran vs. placebo) and scheduled visits (months 3, 4, 5, and 6), baseline 24-hour urinary oxalate corrected for BSA as a continuous fixed covariate, and patient as a random effect. The variance-covariance matrix is assumed to be unstructured. Satterthwaite approximation is used to estimate denominator degrees of freedom.||-0.772|-1.177|<0.0001
71119809|NCT00871117|141745375|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% CI for the between-group differences in booster response to PT was ≥ -10%|Difference in booster response rates|-0.76|||||TWO_SIDED|95.0|-5.07|3.51||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of pertussis toxoid (PT) booster response one month after vaccination with DTaP-IPV vaccine.||3.51|-5.07|
71119810|NCT00871117|141745375|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% CI for the between-group differences in booster response to FHA was ≥ -10%.|Difference in booster response rates|-0.91|||||TWO_SIDED|95.0|-3.59|1.39||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of filamentous hemagglutinin (FHA) booster response one month after vaccination with DTaP-IPV vaccine.||1.39|-3.59|
71119811|NCT00871117|141745375|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% CI for the between-group differences in booster response to PRN, was ≥ -10%.|Difference in booster response rates|1.42|||||TWO_SIDED|95.0|-0.32|4.08||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of pertactin (PRN) booster response one month after vaccination with DTaP-IPV vaccine.||4.08|-0.32|
71119812|NCT00871117|141745376|NON_INFERIORITY|Lower limit of the 95% CI for the GMT ratios for poliovirus type 1 antigens was ≥ 0.67.|Adjusted GMT ratio|0.91|||||TWO_SIDED|95.0|0.76|1.1||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of poliovirus type 1 geometric mean titers (GMTs), one month after vaccination with DTaP-IPV vaccine.||1.1|0.76|
71119813|NCT00871117|141745376|NON_INFERIORITY|Lower limit of the 95% CI for the GMT ratios of poliovirus type 2 antigens was ≥ 0.67.|Adjusted GMT ratio|0.83|||||TWO_SIDED|95.0|0.7|0.99||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of poliovirus type 2 geometric mean titers (GMTs), one month after vaccination with DTaP-IPV vaccine.||0.99|0.7|
71119814|NCT00871117|141745376|NON_INFERIORITY|Lower limit of the 95% CI for the GMT ratios of poliovirus type 3 antigens was ≥ 0.67.|Adjusted GMT ratio|0.84|||||TWO_SIDED|95.0|0.71|1.01||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of poliovirus type 3 geometric mean titers (GMTs), one month after vaccination with DTaP-IPV vaccine.||1.01|0.71|
71119815|NCT03385265|141745393|SUPERIORITY||partial eta squared|0.02|||||TWO_SIDED||||||repeated measures ANOVA|||||||
71119816|NCT03385265|141745394|SUPERIORITY||partial eta squared|0.12|||||TWO_SIDED||||||repeated measures ANOVA|CESD-R = within subject variable; group = between subject variable||||||
71119817|NCT03385265|141745395|SUPERIORITY||partial eta squared|0.03|||||TWO_SIDED||||||repeated measures ANOVA|||||||
71119818|NCT03385265|141745396|SUPERIORITY||partial eta squared|0.06|||||TWO_SIDED||||||repeated measures ANOVA|||||||
71119819|NCT03385265|141745397|SUPERIORITY||partial eta squared|0.04|||||TWO_SIDED||||||repeated measures ANOVA|||||||
71119820|NCT03385265|141745398|SUPERIORITY||partial eta squared|0.04|||<|0.05|TWO_SIDED||||||repeated measures ANOVA|||||||<0.05
71119821|NCT03385265|141745399|SUPERIORITY||partial eta squared|0.24|||||TWO_SIDED||||||repeated measures ANOVA|||||||
71119822|NCT03385265|141745400|SUPERIORITY||partial eta squared|0.03|||||TWO_SIDED||||||repeated measures ANOVA|||||||
71119823|NCT03385265|141745401|SUPERIORITY||partial eta squared|0.04|||||TWO_SIDED||||||repeated measures ANOVA|||||||
71119824|NCT02323204|141745407|OTHER|||||||0.6298|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.6298
71119825|NCT02323204|141745407|OTHER|||||||0.2341|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.2341
71119826|NCT02323204|141745408|OTHER|||||||0.7893|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.7893
71119827|NCT02323204|141745408|OTHER|||||||0.2951|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.2951
71119828|NCT02323204|141745409|OTHER|||||||0.7166|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.7166
71119829|NCT02323204|141745409|OTHER|||||||0.4501|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.4501
71119830|NCT02323204|141745410|OTHER|||||||0.6756|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.6756
71080855|NCT03681184|141668056|SUPERIORITY||Difference in LS Mean|-51.7718|STANDARD_ERROR_OF_MEAN|6.16118|<|0.0001|TWO_SIDED|95.0|-64.2653|-39.2784||P=5.032E-10|MMRM|||The MMRM includes fixed effects of treatment arms (lumasiran vs. placebo) and scheduled visits (months 3, 4, 5, and 6), baseline 24-hour urinary oxalate:creatinine ratio as a continuous fixed covariate, and patient as a random effect. The variance-covariance matrix is assumed to be unstructured. Satterthwaite approximation is used to estimate denominator degrees of freedom.||-39.2784|-64.2653|<0.0001
71080856|NCT03681184|141668057|SUPERIORITY||Difference in Proportions|0.84|||<|0.0001|TWO_SIDED|95.0|0.55|0.94||P=8.341E-07|Cochran-Mantel-Haenszel|||The proportion of participants (lumasiran vs. placebo) with 24-hour urinary oxalate ≤1.5 x ULN at Month 6 is analyzed using the Cochran-Mantel-Haenszel test, stratified by baseline 24-hour urinary oxalate corrected for BSA (≤1.70 mmol/24hr/1.73m\^2 vs. \>1.70 mmol/24hr/1.73m\^2). The difference in proportion (lumasiran vs. placebo) and the corresponding 95% confidence interval are calculated using the Newcombe method, based on the Wilson score.||0.94|0.55|<0.0001
71080857|NCT03681184|141668058|SUPERIORITY||Difference in Proportions|0.52||||0.001|TWO_SIDED|95.0|0.23|0.7|||Cochran-Mantel-Haenszel|||The proportion of participants (lumasiran vs. placebo) with 24-hour urinary oxalate ≤ULN at Month 6 is analyzed using the Cochran-Mantel-Haenszel test, stratified by baseline 24-hour urinary oxalate corrected for BSA (≤1.70 mmol/24hr/1.73m\^2 vs. \>1.70 mmol/24hr/1.73m\^2). The difference in proportion (lumasiran vs. placebo) and the corresponding 95% confidence interval are calculated using the Newcombe method, based on the Wilson score.||0.70|0.23|0.0010
71080858|NCT03681184|141668059|SUPERIORITY||Difference in LS Mean|-39.48|STANDARD_ERROR_OF_MEAN|5.181|<|0.0001|TWO_SIDED|95.0|-50.1|-28.87||P=2.862E-08|MMRM|||The MMRM includes fixed effects of treatment arms (lumasiran vs. placebo) and scheduled visits (months 3, 4, 5, and 6), baseline plasma oxalate as a continuous fixed covariate, and patient as a random effect. The variance-covariance matrix is assumed to be unstructured. Satterthwaite approximation is used to estimate denominator degrees of freedom.||-28.87|-50.10|<0.0001
71080859|NCT03681184|141668060|SUPERIORITY||Difference in LS Mean|-8.71|STANDARD_ERROR_OF_MEAN|1.338|<|0.0001|TWO_SIDED|95.0|-11.45|-5.98||P=3.893E-07|MMRM|||The MMRM includes fixed effects of treatment arms (lumasiran vs. placebo) and scheduled visits (months 3, 4, 5, and 6), baseline plasma oxalate as a continuous fixed covariate, and patient as a random effect. The variance-covariance matrix is assumed to be unstructured. Satterthwaite approximation is used to estimate denominator degrees of freedom.||-5.98|-11.45|<0.0001
71119831|NCT02323204|141745410|OTHER|||||||0.5381|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.5381
71119832|NCT02323204|141745411|OTHER|||||||0.1507|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.1507
71119833|NCT02323204|141745411|OTHER|||||||0.0769|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.0769
71119834|NCT02323204|141745412|OTHER|||||||0.0654|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.0654
71119835|NCT02323204|141745412|OTHER|||||||0.7957|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.7957
70854945|NCT02880956|141198368|SUPERIORITY||LS Mean of Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.887||0.265|TWO_SIDED|95.0|-2.734|0.755||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.755|-2.734|0.265
71080860|NCT04424914|141668099|OTHER|||||||0.3006|||||||Chi-squared|p-values for comparison of proportions of CLASS I+II vs CLASS III+IV were based on a Chi-square test.||||||0.3006
71080861|NCT04424914|141668100|OTHER||||||<|0.0001|||||||Wilcoxon rank sum test|||||||<0.0001
71080862|NCT04485637|141668101|SUPERIORITY||Odds Ratio (OR)|1.67|||=|0.05|TWO_SIDED|95.0|1.0|2.79|||Regression, Logistic|Adjusted for respondent characteristics as described in statistical analysis plan.||Enhanced table \> Basic table||2.79|1.00|=0.05
71080863|NCT04485637|141668101|SUPERIORITY||Odds Ratio (OR)|1.66|||=|0.05|TWO_SIDED|95.0|1.0|2.76|||Regression, Logistic|Adjusted for respondent characteristics as described in statistical analysis plan.||Enhanced graph \> Basic table||2.76|1.00|=0.05
71080864|NCT04485637|141668102|SUPERIORITY|Enhanced table \> Basic table|Odds Ratio (OR)|1.52|||=|0.29|TWO_SIDED|95.0|0.71|3.26|||Regression, Logistic|Adjusted for respondent characteristics as described in statistical analysis plan.||||3.26|0.71|=0.29
71119836|NCT02323204|141745413|OTHER|||||||0.0286|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.0286
70943650|NCT01040403|141387594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.599|STANDARD_ERROR_OF_MEAN|4.83|||TWO_SIDED|95.0|14.116|33.083|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||33.083|14.116|
70943651|NCT01040403|141387594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.097|STANDARD_ERROR_OF_MEAN|4.879|||TWO_SIDED|95.0|20.517|39.677|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||39.677|20.517|
71080865|NCT04485637|141668102|SUPERIORITY|Enhanced graph \> Basic table|Odds Ratio (OR)|0.96|||=|0.9|TWO_SIDED|95.0|0.48|1.93|||Regression, Logistic|Adjusted for respondent characteristics as described in statistical analysis plan.||||1.93|0.48|=0.90
71080866|NCT04485637|141668103|SUPERIORITY||Unst|-0.14|||=|0.13|TWO_SIDED|95.0|-0.32|0.04|||Regression, Linear|Adjusted for respondent characteristics as described in statistical analysis plan.||Enhanced table \> Basic table||0.04|-0.32|=0.13
71080867|NCT04485637|141668103|SUPERIORITY||Unstandardized B|-0.14|||=|0.12|TWO_SIDED|95.0|-0.32|0.04|||Regression, Linear|Adjusted for respondent characteristics as described in statistical analysis plan.||Enhanced graph \> Basic table||0.04|-0.32|=0.12
71080868|NCT04485637|141668104|SUPERIORITY|Enhanced table \> Basic table|Unstandardized B|-0.08|||=|0.33|TWO_SIDED|95.0|-0.25|0.08|||Regression, Linear|||||0.08|-0.25|=0.33
70943652|NCT01040403|141387594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.917|STANDARD_ERROR_OF_MEAN|4.83|||TWO_SIDED|95.0|-4.568|14.402|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||14.402|-4.568|
71080869|NCT04485637|141668104|SUPERIORITY||Unstandardized B|-0.09|||=|0.29|TWO_SIDED|95.0|-0.26|0.08|||Regression, Linear|Adjusted for respondent characteristics as described in statistical analysis plan.||||0.08|-0.26|=0.29
71080870|NCT00492232|141668155|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.71||||0.484||95.0|0.27|1.85||Statistical significance was determined at the 0.05 level.|Regression, Logistic|Log odds of achieving response were estimated using the logistic regression analysis adjusted for effects of treatment and pooled center.||||1.85|0.27|0.484
71080871|NCT00492232|141668156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.946||95.0|-6.23|5.81||P-values are from t-tests of the analysis of covariance (ANCOVA) model for the difference in least squares (LS) means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg) and pooled center as covariates.||||5.81|-6.23|0.946
70854946|NCT02880956|141198368|SUPERIORITY||Effect size/pooled SD|0.16|STANDARD_DEVIATION|6.32|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70943653|NCT01040403|141387594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.415|STANDARD_ERROR_OF_MEAN|4.907|||TWO_SIDED|95.0|1.78|21.05|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||21.050|1.780|
70943654|NCT01040403|141387594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.498|STANDARD_ERROR_OF_MEAN|4.866|||TWO_SIDED|95.0|-3.057|16.053|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||16.053|-3.057|
70943655|NCT01040403|141387594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.742|STANDARD_ERROR_OF_MEAN|4.862|||TWO_SIDED|95.0|8.194|27.29|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||27.290|8.194|
70943656|NCT01040403|141387594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.115|STANDARD_ERROR_OF_MEAN|4.856|||TWO_SIDED|95.0|14.58|33.651|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||33.651|14.580|
71080872|NCT00492232|141668157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.901||95.0|-5.31|6.03||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg) and pooled center as covariates.||||6.03|-5.31|0.901
71080873|NCT00492232|141668158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.538||95.0|-4.32|8.23||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg) and pooled center as covariates.||||8.23|-4.32|0.538
71080874|NCT00492232|141668159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.517||95.0|-9.09|4.6||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg) and pooled center as covariates.||||4.60|-9.09|0.517
71080875|NCT00492232|141668160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.965||95.0|-6.28|6.56||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg) and pooled center as covariates.||||6.56|-6.28|0.965
71080876|NCT00492232|141668161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.617||95.0|-0.27|0.45||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg), baseline zolpidem frequency, and pooled center as covariates.||||0.45|-0.27|0.617
71080877|NCT00492232|141668162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.541||95.0|-0.39|0.74||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg), baseline zolpidem frequency, and pooled center as covariates.||||0.74|-0.39|0.541
71080878|NCT00492232|141668163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55||||0.163||95.0|-0.23|1.33||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg), baseline zolpidem frequency, and pooled center as covariates.||||1.33|-0.23|0.163
71080879|NCT00492232|141668164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.757||95.0|-0.79|1.08||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg), baseline zolpidem frequency, and pooled center as covariates.||||1.08|-0.79|0.757
70943657|NCT01040403|141387594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.095|STANDARD_ERROR_OF_MEAN|4.876|||TWO_SIDED|95.0|15.52|34.67|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||34.670|15.520|
71119837|NCT02323204|141745413|OTHER|||||||0.0201|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.0201
70854947|NCT02880956|141198368|SUPERIORITY||LS Mean of Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.863||0.212|TWO_SIDED|95.0|-2.775|0.618||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.618|-2.775|0.212
71119838|NCT02323204|141745414|OTHER|||||||0.9928|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.9928
71119839|NCT02323204|141745414|OTHER|||||||0.0982|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.0982
71119840|NCT02323204|141745415|OTHER|||||||0.0325|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.0325
71119841|NCT02323204|141745415|OTHER|||||||0.2568|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.2568
71119842|NCT02323204|141745416|OTHER|||||||0.5824|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.5824
71119843|NCT02323204|141745416|OTHER|||||||0.4635|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.4635
71119844|NCT02323204|141745417|OTHER|||||||0.7949|||||||Wald 2-sided t-test|||A Generalized Linear Mixed Model (GLMM) with cumulative logit link and multinomial distribution was fit to the data. A comparison of implementation over time between interventions was made through the intervention-time interaction effect included in the model. Significance in the interaction effect is indicative of a difference in the rate of change in implementation between interventions over time.||||0.7949
71119845|NCT02323204|141745417|OTHER|||||||0.0003|||||||Wald 2-sided t-test|||A Generalized Linear Mixed Model (GLMM) with cumulative logit link and multinomial distribution was fit to the data. A comparison of implementation between interventions was made through the intervention main effect included in the model. The model at hand does not contain an interaction between intervention and time. Significance in the main intervention effect is indicative of a difference in implementation between intervention groups.||||0.0003
71119846|NCT00395135|141745418|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.6|||<|0.0001|TWO_SIDED|95.0|3.0|4.2|||ANCOVA|||||4.2|3.0|<0.0001
71119847|NCT00395135|141745420|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion (%)|-3.67|||<|0.001|TWO_SIDED|95.0|-4.09|-3.25|||ANCOVA|||||-3.25|-4.09|<0.001
71119848|NCT00395135|141745421|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion (%)|-2.58|||<|0.001|TWO_SIDED|95.0|-3.29|-1.88|||ANCOVA|||||-1.88|-3.29|<0.001
71119849|NCT00395135|141745421|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion (%)|1.64|||<|0.001|TWO_SIDED|95.0|1.1|2.19|||ANCOVA|||||2.19|1.10|<0.001
71119850|NCT03831880|141745425|SUPERIORITY||Mean Difference (Final Values)|-15.49|||<|0.0001|TWO_SIDED|95.0|-19.71|-11.27||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-11.27|-19.71|<0.0001
71119851|NCT03831880|141745427|SUPERIORITY||Mean Difference (Final Values)|-5.39||||0.0017|TWO_SIDED|95.0|-8.69|-2.09||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-2.09|-8.69|0.0017
71119852|NCT03831880|141745429|SUPERIORITY||Mean Difference (Final Values)|-13.6|||<|0.0001|TWO_SIDED|95.0|-19.74|-7.45||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-7.45|-19.74|<0.0001
71119853|NCT03831880|141745431|SUPERIORITY||Mean Difference (Final Values)|-24.34|||<|0.0001|TWO_SIDED|95.0|-30.1|-18.57||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-18.57|-30.10|<0.0001
71119854|NCT03831880|141745433|SUPERIORITY||Mean Difference (Final Values)|-7.83||||0.0739|TWO_SIDED|95.0|-16.42|0.77||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||0.77|-16.42|0.0739
70943658|NCT01040403|141387594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.373|STANDARD_ERROR_OF_MEAN|4.896|||TWO_SIDED|95.0|-3.24|15.986|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||15.986|-3.240|
71080880|NCT00492232|141668165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.82||95.0|-0.93|1.17||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg), baseline zolpidem frequency, and pooled center as covariates.||||1.17|-0.93|0.820
71119855|NCT03831880|141745435|SUPERIORITY||Mean Difference (Final Values)|-17.6|||<|0.0001|TWO_SIDED|95.0|-25.15|-10.06||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-10.06|-25.15|<0.0001
71119856|NCT03831880|141745437|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.6137|TWO_SIDED|95.0|-2.09|3.51||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||3.51|-2.09|0.6137
71119857|NCT03831880|141745439|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.8404|TWO_SIDED|95.0|-5.29|6.41||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||6.41|-5.29|0.8404
71119858|NCT03831880|141745441|SUPERIORITY||Mean Difference (Final Values)|-13.47|||<|0.0001|TWO_SIDED|95.0|-17.59|-9.35||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-9.35|-17.59|<0.0001
71119859|NCT03831880|141745443|SUPERIORITY||Mean Difference (Final Values)|-2.76||||0.0245|TWO_SIDED|95.0|-5.16|-0.36||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-0.36|-5.16|0.0245
71119860|NCT03831880|141745455|SUPERIORITY||Mean Difference (Final Values)|-14.58|||<|0.0001|TWO_SIDED|95.0|-18.72|-10.44||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-10.44|-18.72|<0.0001
71119861|NCT01852825|141745462|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|2.355||||0.003|TWO_SIDED|90.0|1.515|3.661|||Constrained Longitudinal Data Analysis||MK-8237 treatment divided by Placebo treatment|The hypothesis is supported if the lower bound of the two-sided 90% confidence interval for the Week 12 geometric mean fold difference is \>1.0.||3.661|1.515|0.003
70854948|NCT02880956|141198368|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|6.29|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70943659|NCT01040403|141387594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.353|STANDARD_ERROR_OF_MEAN|4.845|||TWO_SIDED|95.0|-2.161|16.866|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||16.866|-2.161|
71119862|NCT01852825|141745463|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|2.182||||0.01|TWO_SIDED|90.0|1.364|3.49|||Constrained Longitudinal Data Analysis||MK-8237 treatment divided by Placebo treatment|The hypothesis is supported if the lower bound of the two-sided 90% confidence interval for the Week 12 geometric mean fold difference is \>1.0.||3.490|1.364|0.010
71119863|NCT01852825|141745464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238||||0.027|TWO_SIDED|90.0|0.066|0.41|||Constrained Longitudinal Data Analysis||MK-8237 treatment minus Placebo treatment|The hypothesis is supported if the lower bound of the 1-tailed 95% CI around the mean difference in change from baseline excludes zero||0.410|0.066|0.027
70943660|NCT01040403|141387594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.98|STANDARD_ERROR_OF_MEAN|4.861|||TWO_SIDED|95.0|-8.566|10.525|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||10.525|-8.566|
71080881|NCT00492232|141668167|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.01||||0.284||95.0|0.55|7.34||P-values are from Chi-square tests of the log-regression model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|Regression, Logistic|Log odds of achieving response were estimated using logistic regression analysis adjusted for effects of baseline zolpidem dosage (≤10 mg vs \>10 mg).||||7.34|0.55|0.284
71119864|NCT01852825|141745465|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.068||||0.935|TWO_SIDED|90.0|0.272|4.19|||Constrained Longitudinal Data Analysis||MK-8237 treatment divided by Placebo treatment|||4.190|0.272|0.935
71119865|NCT01852825|141745466|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|2.21||||0.296|TWO_SIDED|90.0|0.605|8.066|||Constrained Longitudinal Data Analysis||MK-8237 treatment divided by Placebo treatment|||8.066|0.605|0.296
70854949|NCT02880956|141198368|SUPERIORITY||LS Mean of Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.893||0.602|TWO_SIDED|95.0|-2.223|1.29||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.290|-2.223|0.602
70854950|NCT02880956|141198368|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|6.35|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70854951|NCT02880956|141198368|SUPERIORITY||LS Mean of Difference|-0.48|STANDARD_ERROR_OF_MEAN|1.019||0.635|TWO_SIDED|95.0|-2.489|1.519||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.519|-2.489|0.635
70943661|NCT01040403|141387595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17|STANDARD_ERROR_OF_MEAN|4.853|||TWO_SIDED|95.0|-8.36|10.699|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||10.699|-8.360|
71119866|NCT01852825|141745467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-61.115||||0.014|TWO_SIDED|90.0|-100.185|-22.045|||Constrained Longitudinal Data Analysis||MK-8237 treatment minus Placebo treatment|||-22.045|-100.185|0.014
71119867|NCT01327274|141745470|OTHER|Pre-treatment and post-treatment Pectus Severity Indices were compared using the Wilcoxon matched-pairs signed rank test.||||||0.486|||||||Wilcoxon (Mann-Whitney)|||||||0.486
71119868|NCT01095653|141745477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.0975|<|0.0001|TWO_SIDED|95.0|-0.94|-0.56||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment|ANCOVA|||||-0.56|-0.94|<0.0001
71119869|NCT01095653|141745477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.0962|<|0.0001|TWO_SIDED|95.0|-1.01|-0.63||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment|ANCOVA|||||-0.63|-1.01|<0.0001
71119870|NCT01095653|141745478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.7|STANDARD_ERROR_OF_MEAN|3.203|<|0.0001|TWO_SIDED|95.0|-34.0|-21.4||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-21.4|-34.0|<0.0001
71119871|NCT01095653|141745478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-34.2|STANDARD_ERROR_OF_MEAN|3.174|<|0.0001|TWO_SIDED|95.0|-40.4|-27.9||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-27.9|-40.4|<0.0001
71119872|NCT01095653|141745479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.9|STANDARD_ERROR_OF_MEAN|6.5667|<|0.0001|TWO_SIDED|95.0|-60.8|-34.96||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-34.96|-60.80|<0.0001
71119873|NCT01095653|141745479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-56.0|STANDARD_ERROR_OF_MEAN|6.4489|<|0.0001|TWO_SIDED|95.0|-68.66|-43.28||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-43.28|-68.66|<0.0001
71119874|NCT01095653|141745480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|0.3259|<|0.0001|TWO_SIDED|95.0|-2.01|-0.73||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-0.73|-2.01|<0.0001
71119875|NCT01095653|141745480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|0.3242|<|0.0001|TWO_SIDED|95.0|-2.62|-1.34||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-1.34|-2.62|<0.0001
71119876|NCT01095653|141745481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.3|STANDARD_ERROR_OF_MEAN|5.238|<|0.0001|TWO_SIDED|95.0|11.1|31.6||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|Modified logistic regression|||||31.6|11.1|<0.0001
71119877|NCT01095653|141745481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.5|STANDARD_ERROR_OF_MEAN|5.022|<|0.0001|TWO_SIDED|95.0|18.6|38.3||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|Modified logistic regression|||||38.3|18.6|<0.0001
71119878|NCT02752958|141745487|OTHER||Mean Difference (Final Values)|5.89||||0.0944|TWO_SIDED|95.0|-1.018|12.8|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus Week 4 score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 (Baseline ) versus (vs.) Week 4||12.80|-1.018|0.0944
71119879|NCT02752958|141745488|OTHER||Mean Difference (Final Values)|16.99|||<|0.0001|TWO_SIDED|95.0|10.128|23.849|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 (baseline) vs. Week 8||23.849|10.128|<0.0001
71119880|NCT02752958|141745489|OTHER||Mean Difference (Final Values)|22.7|||<|0.0001|TWO_SIDED|95.0|15.87|29.539|||ANOVA|From ANOVA model with visit and site as fixed effect and participant as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 (baseline) vs. Week 12||29.539|15.870|<0.0001
71119881|NCT02752958|141745490|OTHER||Mean Difference (Final Values)|27.21|||<|0.0001|TWO_SIDED|95.0|20.245|34.165|||ANOVA|From ANOVA model with visit and site as fixed effect and participant as random effect. Visit\*site interaction included where significant at 10% level|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 (baseline) vs. Week 16||34.165|20.245|<0.0001
70854952|NCT02880956|141198368|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|6.31|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70854953|NCT02880956|141198368|SUPERIORITY||LS Mean of Difference|-0.26|STANDARD_ERROR_OF_MEAN|1.003||0.795|TWO_SIDED|95.0|-2.233|1.712||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.712|-2.233|0.795
70854954|NCT02880956|141198368|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|7.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70854955|NCT02880956|141198368|SUPERIORITY||LS Mean of Difference|1.11|STANDARD_ERROR_OF_MEAN|1.027||0.281|TWO_SIDED|95.0|-0.91|3.128||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||3.128|-0.910|0.281
70854956|NCT02880956|141198368|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|7.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71080882|NCT00492232|141668168|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.42||||0.389||95.0|0.64|3.13||P-values are from Chi-square tests of the log-regression model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|Regression, Logistic|Log odds of achieving response were estimated using logistic regression analysis adjusted for effects of baseline zolpidem dosage (≤10 mg vs \>10 mg).||||3.13|0.64|0.389
71080883|NCT02453256|141668169|SUPERIORITY||Difference in least square means|-1.73||||0.0983|TWO_SIDED|95.0|-3.78|0.32|||Repeated Measure|||Difference in least square means between the TCZ group and the Placebo group at week 48. Null hypothesis: There is no difference between the TCZ group and the placebo group in mean change in mRSS from baseline to Week 48.||0.32|-3.78|0.0983
70943662|NCT01040403|141387595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.436|STANDARD_ERROR_OF_MEAN|4.843|||TWO_SIDED|95.0|-5.073|13.945|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||13.945|-5.073|
70943663|NCT01040403|141387595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.189|STANDARD_ERROR_OF_MEAN|4.887|||TWO_SIDED|95.0|-4.407|14.785|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||14.785|-4.407|
70943664|NCT01040403|141387595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.267|STANDARD_ERROR_OF_MEAN|4.828|||TWO_SIDED|95.0|-6.214|12.747|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||12.747|-6.214|
70943665|NCT01040403|141387595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.02|STANDARD_ERROR_OF_MEAN|4.904|||TWO_SIDED|95.0|-5.61|13.65|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||13.650|-5.610|
70943666|NCT01040403|141387595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.753|STANDARD_ERROR_OF_MEAN|4.873|||TWO_SIDED|95.0|-8.816|10.322|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||10.322|-8.816|
70854957|NCT02880956|141198368|SUPERIORITY||LS Mean of Difference|-0.44|STANDARD_ERROR_OF_MEAN|1.261||0.729|TWO_SIDED|95.0|-2.918|2.043||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.043|-2.918|0.729
70854958|NCT02880956|141198368|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|7.4|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70943667|NCT01040403|141387595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.986|STANDARD_ERROR_OF_MEAN|4.876|||TWO_SIDED|95.0|-6.589|12.561|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||12.561|-6.589|
70943668|NCT01040403|141387595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.916|STANDARD_ERROR_OF_MEAN|4.868|||TWO_SIDED|95.0|-4.643|14.475|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||14.475|-4.643|
70943669|NCT01040403|141387595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.432|STANDARD_ERROR_OF_MEAN|4.882|||TWO_SIDED|95.0|-2.154|17.019|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||17.019|-2.154|
70943670|NCT01040403|141387595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.93|STANDARD_ERROR_OF_MEAN|4.909|||TWO_SIDED|95.0|-7.708|11.568|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||11.568|-7.708|
70943671|NCT01040403|141387595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.446|STANDARD_ERROR_OF_MEAN|4.854|||TWO_SIDED|95.0|-5.085|13.978|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||13.978|-5.085|
70943672|NCT01040403|141387595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.517|STANDARD_ERROR_OF_MEAN|4.87|||TWO_SIDED|95.0|-7.046|12.079|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||12.079|-7.046|
70943673|NCT01040403|141387599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.212|STANDARD_ERROR_OF_MEAN|0.158|||TWO_SIDED|95.0|-0.523|0.099|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|Week 1||0.099|-0.523|
70943674|NCT01040403|141387599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.319|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.634|-0.004|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|Week 1||-0.004|-0.634|
70943675|NCT01040403|141387599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.065|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.379|0.249|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|Week 1||0.249|-0.379|
71119882|NCT02752958|141745491|OTHER||Mean Difference (Final Values)|31.42|||<|0.0001|TWO_SIDED|95.0|24.464|38.385|||ANOVA|From ANOVA model with visit and site as fixed effect and participant as random effect. Visit\*site interaction included where significant at 10% level.||Week 0 Vs Week 20||38.385|24.464|<.0001
71119883|NCT02752958|141745492|OTHER||Mean Difference (Final Values)|32.55|||<|0.0001|TWO_SIDED|95.0|25.585|39.506|||ANOVA|From ANOVA model with visit and site as fixed effect and participant as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 (baseline) vs. Week 24||39.506|25.585|<.0001
71119884|NCT02752958|141745493|OTHER||Mean Difference (Final Values)|1.18||||0.0312|TWO_SIDED|95.0|0.108|2.262|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 4||2.262|0.108|0.0312
71119885|NCT02752958|141745494|OTHER||Mean Difference (Final Values)|2.8|||<|0.0001|TWO_SIDED|95.0|1.728|3.866|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 8||3.866|1.728|<.0001
71119886|NCT02752958|141745495|OTHER||Mean Difference (Final Values)|3.26|||<|0.0001|TWO_SIDED|95.0|2.192|4.322|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 12||4.322|2.192|<.0001
71119887|NCT02752958|141745496|OTHER||Mean Difference (Final Values)|3.93|||<|0.0001|TWO_SIDED|95.0|2.844|5.012|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|||5.012|2.844|<.0001
71119888|NCT02752958|141745497|OTHER||Mean Difference (Final Values)|4.15|||<|0.0001|TWO_SIDED|95.0|3.063|5.232|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 20||5.232|3.063|<.0001
71119889|NCT02752958|141745498|OTHER||Mean Difference (Final Values)|4.74|||<|0.0001|TWO_SIDED|95.0|3.654|5.823|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24||5.823|3.654|<.0001
71119890|NCT02752958|141745499|OTHER||Mean Difference (Final Values)|1.11||||0.4185|TWO_SIDED|95.0|-1.592|3.821|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline|Week 0 Vs Week 4||3.821|-1.592|0.4185
71119891|NCT02752958|141745500|OTHER||Mean Difference (Final Values)|7.08|||<|0.0001|TWO_SIDED|95.0|4.391|9.764|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 8||9.764|4.391|<.0001
70943676|NCT01040403|141387599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.107|STANDARD_ERROR_OF_MEAN|0.159|||TWO_SIDED|95.0|-0.42|0.206|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|Week 1||0.206|-0.420|
71119892|NCT02752958|141745501|OTHER||Mean Difference (Final Values)|8.35|||<|0.0001|TWO_SIDED|95.0|5.674|11.026|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Valu|Week 0 Vs Week 12||11.026|5.674|<.0001
71119893|NCT02752958|141745502|OTHER|Week 0 Vs Week 16|Mean Difference (Final Values)|10.43|||<|0.0001|TWO_SIDED|95.0|7.708|13.158|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 16||13.158|7.708|<.0001
71119894|NCT02752958|141745503|OTHER||Mean Difference (Final Values)|11.73|||<|0.0001|TWO_SIDED|95.0|9.008|14.459|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 20||14.459|9.008|<.0001
71119895|NCT02752958|141745504|OTHER||Mean Difference (Final Values)|11.96|||<|0.0001|TWO_SIDED|95.0|9.235|14.686|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24||14.686|9.235|<.0001
71119896|NCT02752958|141745505|OTHER||Mean Difference (Final Values)|0.57||||0.3415|TWO_SIDED|95.0|-0.604|1.738|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 vs Week 4||1.738|-0.604|0.3415
71119897|NCT02752958|141745506|OTHER||Mean Difference (Final Values)|1.77||||0.0029|TWO_SIDED|95.0|0.61|2.935|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline|Week 0 Vs Week 8||2.935|0.610|0.0029
71119898|NCT02752958|141745507|OTHER||Mean Difference (Final Values)|2.42|||<|0.0001|TWO_SIDED|95.0|1.266|3.582|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 12||3.582|1.266|<0.0001
71119899|NCT02752958|141745508|OTHER||Mean Difference (Final Values)|3.55|||<|0.0001|TWO_SIDED|95.0|2.371|4.729|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 vs Week 16||4.729|2.371|<.0001
70854959|NCT02880956|141198368|SUPERIORITY||LS Mean of Difference|-0.59|STANDARD_ERROR_OF_MEAN|1.248||0.636|TWO_SIDED|95.0|-3.047|1.863||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.863|-3.047|0.636
70943677|NCT01040403|141387599|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.147|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.168|0.462|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|Week 1||0.462|-0.168|
70943678|NCT01040403|141387599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.255|STANDARD_ERROR_OF_MEAN|0.161|||TWO_SIDED|95.0|-0.062|0.571|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|Week 1||0.571|-0.062|
70943679|NCT01040403|141387599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.271|0.355|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|Week 1||0.355|-0.271|
70943680|NCT01040403|141387599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.251|STANDARD_ERROR_OF_MEAN|0.159|||TWO_SIDED|95.0|-0.564|0.062|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|Week 1||0.062|-0.564|
70943681|NCT01040403|141387599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.178|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.492|0.135|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|Week 1||0.135|-0.492|
70943682|NCT01040403|141387599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.293|STANDARD_ERROR_OF_MEAN|0.162|||TWO_SIDED|95.0|-0.611|0.024|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|Week 1||0.024|-0.611|
70943683|NCT01040403|141387599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.221|STANDARD_ERROR_OF_MEAN|0.159|||TWO_SIDED|95.0|-0.533|0.092|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|Week 1||0.092|-0.533|
71080884|NCT02453256|141668170|SUPERIORITY||Weighted difference|21.91||||0.0007|TWO_SIDED|95.0|9.2|34.6|||Cochran-Mantel-Haenszel|||This statistical analysis applies to participants with ≥ 20% improvement in mRSS.||34.6|9.2|0.0007
70943684|NCT01040403|141387599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.242|0.388|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|Week 1||0.388|-0.242|
70854960|NCT02880956|141198368|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|7.46|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70943685|NCT01040403|141387599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.179|||TWO_SIDED|95.0|-0.241|0.462|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|Week 4||0.462|-0.241|
70943686|NCT01040403|141387599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.092|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-0.445|0.261|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|Week 4||0.261|-0.445|
70943687|NCT01040403|141387599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-0.301|0.406|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|Week 4||0.406|-0.301|
70943688|NCT01040403|141387599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.202|STANDARD_ERROR_OF_MEAN|0.179|||TWO_SIDED|95.0|-0.555|0.15|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|Week 4||0.150|-0.555|
70943689|NCT01040403|141387599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.058|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-0.411|0.296|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|Week 4||0.296|-0.411|
71080885|NCT02453256|141668170|SUPERIORITY||Weighted difference|4.32||||0.5139|TWO_SIDED|95.0|-8.7|17.3|||Cochran-Mantel-Haenszel|||This statistical analysis applies to participants with ≥ 40% improvement in mRSS.||17.3|-8.7|0.5139
71080886|NCT02453256|141668170|SUPERIORITY||Weighted difference|-5.41||||0.3276|TWO_SIDED|95.0|-16.2|5.4|||Cochran-Mantel-Haenszel|||This statistical analysis applies to participants with ≥ 60% improvement in mRSS.||5.4|-16.2|0.3276
70943690|NCT01040403|141387599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.179|||TWO_SIDED|95.0|-0.208|0.496|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|Week 4||0.496|-0.208|
70854961|NCT02880956|141198368|SUPERIORITY||LS Mean of Difference|1.03|STANDARD_ERROR_OF_MEAN|1.294||0.427|TWO_SIDED|95.0|-1.515|3.575||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||3.575|-1.515|0.427
70854962|NCT02880956|141198368|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|7.9|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70943691|NCT01040403|141387599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.217|STANDARD_ERROR_OF_MEAN|0.179|||TWO_SIDED|95.0|-0.568|0.135|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|Week 4||0.135|-0.568|
70943692|NCT01040403|141387599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.363|STANDARD_ERROR_OF_MEAN|0.179|||TWO_SIDED|95.0|-0.714|-0.012|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|Week 4||-0.012|-0.714|
70943693|NCT01040403|141387599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.246|STANDARD_ERROR_OF_MEAN|0.179|||TWO_SIDED|95.0|-0.598|0.106|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|Week 4||0.106|-0.598|
70854963|NCT02880956|141198369|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.053||0.69|TWO_SIDED|95.0|-0.083|0.126||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.126|-0.083|0.690
70943694|NCT01040403|141387599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.146|STANDARD_ERROR_OF_MEAN|0.182|||TWO_SIDED|95.0|-0.503|0.21|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|Week 4||0.210|-0.503|
71080887|NCT02453256|141668171|SUPERIORITY|||||||0.0015||||||P-value from Van Elteren analysis stratified by IL-6 level (\<10; \>=10 pg/mL) at screening.|Van Elteren|||||||0.0015
71119900|NCT02752958|141745509|OTHER||Mean Difference (Final Values)|4.39|||<|0.0001|TWO_SIDED|95.0|3.21|5.568|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 20||5.568|3.210|<0.0001
71119901|NCT02752958|141745510|OTHER||Mean Difference (Final Values)|4.3|||<|0.0001|TWO_SIDED|95.0|3.119|5.477|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24||5.477|3.119|<0.0001
71119902|NCT02752958|141745511|OTHER||Mean Difference (Final Values)|2.42||||0.0145|TWO_SIDED|95.0|0.483|4.352|||ANOVA||Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 4||4.352|0.483|0.0145
71119903|NCT02752958|141745512|OTHER||Mean Difference (Final Values)|4.42|||<|0.0001|TWO_SIDED|95.0|2.498|6.339|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 8||6.339|2.498|<0.0001
71119904|NCT02752958|141745513|OTHER||Mean Difference (Final Values)|6.85|||<|0.0001|TWO_SIDED|95.0|4.933|8.759|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 12||8.759|4.933|<0.0001
71119905|NCT02752958|141745514|OTHER||Mean Difference (Final Values)|7.17|||<|0.0001|TWO_SIDED|95.0|5.219|9.115|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 16||9.115|5.219|<.0001
71119906|NCT02752958|141745515|OTHER||Mean Difference (Final Values)|8.39|||<|0.0001|TWO_SIDED|95.0|6.438|10.335|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 20||10.335|6.438|<0.0001
71119907|NCT02752958|141745516|OTHER||Mean Difference (Final Values)|8.67|||<|0.0001|TWO_SIDED|95.0|6.726|10.623|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 24||10.623|6.726|<0.0001
71119908|NCT02752958|141745517|OTHER||Mean Difference (Final Values)|0.63||||0.3676|TWO_SIDED|95.0|-0.738|1.989|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 4||1.989|-0.738|0.3676
71119909|NCT02752958|141745518|OTHER||Mean Difference (Final Values)|0.9||||0.1907|TWO_SIDED|95.0|-0.451|2.255|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 8||2.255|-0.451|0.1907
71119910|NCT02752958|141745519|OTHER||Mean Difference (Final Values)|1.81||||0.0085|TWO_SIDED|95.0|0.467|3.162|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 12||3.162|0.467|0.0085
71119911|NCT02752958|141745520|OTHER||Mean Difference (Final Values)|2.12||||0.0026|TWO_SIDED|95.0|0.744|3.489|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 16||3.489|0.744|0.0026
71119912|NCT02752958|141745521|OTHER||Mean Difference (Final Values)|2.74||||0.0001|TWO_SIDED|95.0|1.371|4.116|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.||Week 0 Vs Week 20||4.116|1.371|0.0001
71119913|NCT02752958|141745522|OTHER||Mean Difference (Final Values)|2.85|||<|0.0001|TWO_SIDED|95.0|1.477|4.222|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 vs Week 24||4.222|1.477|<.0001
71119914|NCT02752958|141745523|OTHER||Mean Difference (Final Values)|0.09||||0.2326|TWO_SIDED|95.0|-0.059|0.243|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Valu|Week 0 Vs Week 4||0.243|-0.059|0.2326
71119915|NCT02752958|141745524|OTHER||Mean Difference (Final Values)|0.07||||0.3934|TWO_SIDED|95.0|-0.085|0.216||From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|ANOVA||Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 8||0.216|-0.085|0.3934
70943695|NCT01040403|141387599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.029|STANDARD_ERROR_OF_MEAN|0.178|||TWO_SIDED|95.0|-0.379|0.321|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|Week 4||0.321|-0.379|
70943696|NCT01040403|141387599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-0.235|0.47|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|Week 4||0.470|-0.235|
70854964|NCT02880956|141198369|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|0.39|||TWO_SIDED|95.0|||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70854965|NCT02880956|141198369|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.052||0.595|TWO_SIDED|95.0|-0.075|0.131||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.131|-0.075|0.595
71119916|NCT02752958|141745525|OTHER||Mean Difference (Final Values)|0.13||||0.0795|TWO_SIDED|95.0|-0.016|0.284|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 12||0.284|-0.016|0.0795
71119917|NCT02752958|141745526|OTHER||Mean Difference (Final Values)|0.14||||0.0682|TWO_SIDED|95.0|-0.011|0.294|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 vs Week 16||0.294|-0.011|0.0682
71119918|NCT02752958|141745527|OTHER||Mean Difference (Final Values)|0.13||||0.0844|TWO_SIDED|95.0|-0.018|0.287|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 20||0.287|-0.018|0.0844
70854966|NCT02880956|141198369|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|0.36|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70943697|NCT01040403|141387600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.223|0.25|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|Day 1||0.250|-0.223|
70943698|NCT01040403|141387600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.133|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.37|0.104|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|Day 1||0.104|-0.370|
71119919|NCT02752958|141745528|OTHER||Mean Difference (Final Values)|0.18||||0.0211|TWO_SIDED|95.0|0.027|0.332|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 24||0.332|0.027|0.0211
70943699|NCT01040403|141387600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|0.122|||TWO_SIDED|95.0|-0.278|0.199|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|Day 1||0.199|-0.278|
71080888|NCT02453256|141668172|SUPERIORITY||Difference in least square means|0.167||||0.0001|TWO_SIDED|95.0|0.083|0.25|||Repeated Measure|||||0.250|0.083|0.0001
70854967|NCT02880956|141198369|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.054||0.201|TWO_SIDED|95.0|0.037|0.175||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.175|0.037|0.201
70854968|NCT02880956|141198369|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|0.45|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70943700|NCT01040403|141387600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.147|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.382|0.088|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|Day 1||0.088|-0.382|
70943701|NCT01040403|141387600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.291|0.186|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|Day 1||0.186|-0.291|
70943702|NCT01040403|141387600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.144|0.332|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|Day 1||0.332|-0.144|
70943703|NCT01040403|141387600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.282|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.519|-0.045|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|Day 1||-0.045|-0.519|
71080889|NCT02453256|141668173|SUPERIORITY||Difference in least square means|-0.053||||0.4489|TWO_SIDED|95.0|-0.192|0.085|||Repeated Measure|||||0.085|-0.192|0.4489
71080890|NCT02453256|141668174|SUPERIORITY||Difference in least square means|-2.44||||0.4339|TWO_SIDED|95.0|-8.57|3.7|||Repeated Measure|||||3.70|-8.57|0.4339
71080891|NCT02453256|141668175|SUPERIORITY||Difference in least square means|-2.46||||0.4378|TWO_SIDED|95.0|-8.72|3.79|||Repeated Measure|||||3.79|-8.72|0.4378
71080892|NCT02453256|141668176|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0821|TWO_SIDED|95.0|0.37|1.06|||Cox-proportional hazards model|||||1.06|0.37|0.0821
71080893|NCT00636636|141668227|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.2||0.0125|TWO_SIDED|95.0|-0.88|-0.11|||ANCOVA|||||-0.11|-0.88|0.0125
71080894|NCT00636636|141668228|SUPERIORITY_OR_OTHER||Difference in proportion|0.092||||0.0434|TWO_SIDED|95.0|0.0|0.18|||Z test|||P-value (vs Placebo) for pairwise test of treatment effect between G-ER group and Placebo group is based on Z test for difference between the 2 groups in proportion of participants who were categorized as very much or much improved in PGIC at endpoint. Proportion in each group calculated from number of participants categorized as very much or much improved relative to total number of participants in ITT population.||0.18|-0.00|0.0434
71080895|NCT00636636|141668229|SUPERIORITY_OR_OTHER||Difference in proportion|0.102||||0.0268|TWO_SIDED|95.0|0.01|0.19|||Z test|||P-value (vs Placebo) for pairwise test of treatment effect between G-ER group and Placebo group is based on Z test for difference between the 2 groups in proportion of participants who were categorized as very much or much improved in CGIC at endpoint. Proportion in each group calculated from number of participants categorized as very much or much improved relative to total number of participants in ITT population.||0.19|0.01|0.0268
71080896|NCT00636636|141668230|SUPERIORITY_OR_OTHER||Least square mean difference|-0.71|STANDARD_ERROR_OF_MEAN|0.18||0.0001|TWO_SIDED|95.0|-1.07|-0.35|||ANCOVA||P-value versus Placebo for pairwise test of difference of LS mean change from baseline between G-ER and Placebo groups is based on t-test of Type III analysis.|||-0.35|-1.07|0.0001
71080897|NCT00636636|141668231|SUPERIORITY_OR_OTHER||Least square mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.2||0.007|TWO_SIDED|95.0|-0.96|-0.15|||ANCOVA|||||-0.15|-0.96|0.007
71080898|NCT01237327|141668236|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7799||||0.3348|TWO_SIDED|95.0|0.47|1.294|||Log Rank|||Overall survival compared using the hazard ratio; hazard ratio \<1.0 is in favor of exemestane.||1.294|0.47|0.3348
71080899|NCT04811664|141668260|SUPERIORITY||Vaccine efficacy, (1-HR) *100%|52.6|||||TWO_SIDED|95.0|-14.1|80.3|||||"Immediate Vaccination compared to Standard of care (reference). Wald 95% CI."|Cox model on the calendar time scale, stratified by site and adjusted for sex, residence, team sport participation, mask wearing and SARS-CoV-2 exposure risk score. Outside vaccination censoring.||80.3|-14.1|
71080900|NCT04811664|141668263|SUPERIORITY||Vaccine efficacy, (1-HR) *100%|71.0|||||TWO_SIDED|95.0|-9.5|92.3|||||"Immediate Vaccination compared to Standard of care (reference). Wald 95% CI."|Cox model on the calendar time scale, stratified by site and adjusted for sex, residence, team sport participation, mask wearing and SARS-CoV-2 exposure risk score. Outside vaccination censoring.||92.3|-9.5|
71080901|NCT04811664|141668264|SUPERIORITY||Vaccine efficacy, (1-HR) *100%|41.2|||||TWO_SIDED|95.0|-37.7|74.9|||||"Immediate Vaccination compared to Standard of care (reference). Wald 95% CI."|Cox model on the calendar time scale, stratified by site and adjusted for sex, residence, team sport participation, mask wearing and SARS-CoV-2 exposure risk score. Outside vaccination censoring.||74.9|-37.7|
71080902|NCT05052697|141668319|OTHER||Geometric Mean Ratio|0.86|||||TWO_SIDED|95.0|0.34|2.2|||||GMRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the difference (qIRV group minus QIV group) and the corresponding CIs (based on the Student t distribution).|Strain: A1||2.20|0.34|
71080903|NCT05052697|141668319|OTHER||Geometric Mean Ratio|1.53|||||TWO_SIDED|95.0|0.86|2.7|||||GMRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the difference (qIRV group minus QIV group) and the corresponding CIs (based on the Student t distribution).|Strain: A2||2.70|0.86|
71080904|NCT05052697|141668319|OTHER||Geometric Mean Ratio|0.96|||||TWO_SIDED|95.0|0.4|2.28|||||GMRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the difference (qIRV group minus QIV group) and the corresponding CIs (based on the Student t distribution).|Strain: B1||2.28|0.40|
71080905|NCT05052697|141668319|OTHER||Geometric Mean Ratio|0.54|||||TWO_SIDED|95.0|0.25|1.18|||||GMRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the difference (qIRV group minus QIV group) and the corresponding CIs (based on the Student t distribution).|Strain: B2||1.18|0.25|
71080906|NCT05052697|141668320|OTHER||Difference in percentage of participants|26.2|||||TWO_SIDED|95.0|-4.5|53.5|||||Difference in percentage of participants achieving seroconversion, qIRV group - Licensed QIV group as reference, expressed as a percentage.|Strain: A1||53.5|-4.5|
70854969|NCT02880956|141198369|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.064||0.361|TWO_SIDED|95.0|-0.067|0.184||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.184|-0.067|0.361
70943704|NCT01040403|141387600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.113|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.35|0.124|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|Day 1||0.124|-0.350|
70943705|NCT01040403|141387600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.056|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.293|0.18|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|Day 1||0.180|-0.293|
70943706|NCT01040403|141387600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.069|0.408|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|Day 1||0.408|-0.069|
70943707|NCT01040403|141387600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.01|0.461|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|Day 1||0.461|-0.010|
70943708|NCT01040403|141387600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.18|0.293|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|Day 1||0.293|-0.180|
70943709|NCT01040403|141387600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.067|0.387|||Mixed Models Analysis||Difference calculated as T+O 1.25/ minus Olo 5|Day 29||0.387|-0.067|
70943710|NCT01040403|141387600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.262|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|0.034|0.491|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|Day 29||0.491|0.034|
70943711|NCT01040403|141387600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.118|||TWO_SIDED|95.0|-0.148|0.316|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|Day 29||0.316|-0.148|
70943712|NCT01040403|141387600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.115|||TWO_SIDED|95.0|-0.124|0.328|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|Day 29||0.328|-0.124|
70943713|NCT01040403|141387600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.076|STANDARD_ERROR_OF_MEAN|0.117|||TWO_SIDED|95.0|-0.306|0.154|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|Day 29||0.154|-0.306|
70943714|NCT01040403|141387600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.178|STANDARD_ERROR_OF_MEAN|0.117|||TWO_SIDED|95.0|-0.408|0.052|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|Day 29||0.052|-0.408|
71119920|NCT02752958|141745529|OTHER||Mean Difference (Final Values)|0.6||||0.0493|TWO_SIDED|95.0|0.002|1.194|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 4||1.194|0.002|0.0493
71119921|NCT02752958|141745530|OTHER||Mean Difference (Final Values)|1.42|||<|0.0001|TWO_SIDED|95.0|0.83|2.013|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 8||2.013|0.830|<0.0001
70943715|NCT01040403|141387600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.056|0.4|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|Day 29||0.400|-0.056|
70943716|NCT01040403|141387600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.171|0.285|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|Day 29||0.285|-0.171|
70943717|NCT01040403|141387600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.11|0.346|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|Day 29||0.346|-0.110|
70943718|NCT01040403|141387600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.115|STANDARD_ERROR_OF_MEAN|0.117|||TWO_SIDED|95.0|-0.345|0.115|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|Day 29||0.115|-0.345|
70943719|NCT01040403|141387600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.281|0.173|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|Day 29||0.173|-0.281|
70943720|NCT01040403|141387600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.166|0.289|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|Day 29||0.289|-0.166|
70943721|NCT01040403|141387601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.222|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.481|0.037|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.037|-0.481|
70943722|NCT01040403|141387601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.441|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.7|-0.182|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||-0.182|-0.700|
70943723|NCT01040403|141387601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.149|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|95.0|-0.409|0.111|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.111|-0.409|
70943724|NCT01040403|141387601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.219|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.478|0.04|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.040|-0.478|
70943725|NCT01040403|141387601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|95.0|-0.189|0.335|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.335|-0.189|
70943726|NCT01040403|141387601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.292|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|95.0|0.031|0.553|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.553|0.031|
70943727|NCT01040403|141387601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.382|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.641|-0.123|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||-0.123|-0.641|
71119922|NCT02752958|141745531|OTHER||Mean Difference (Final Values)|1.87|||<|0.0001|TWO_SIDED|95.0|1.278|2.457||From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|ANOVA||Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 12||2.457|1.278|<0.0001
71119923|NCT02752958|141745532|OTHER||Mean Difference (Final Values)|2.03|||<|0.0001|TWO_SIDED|95.0|1.429|2.629|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 16||2.629|1.429|<.0001
71119924|NCT02752958|141745533|OTHER||Mean Difference (Final Values)|2.34|||<|0.0001|TWO_SIDED|95.0|1.743|2.943|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 20||2.943|1.743|<.0001
71119925|NCT02752958|141745534|OTHER||Mean Difference (Final Values)|2.34|||<|0.0001|TWO_SIDED|95.0|1.743|2.943|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24||2.943|1.743|<.0001
71119926|NCT02752958|141745535|OTHER||Mean Difference (Final Values)|0.88|||<|0.0001|TWO_SIDED|95.0|0.474|1.295|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 4||1.295|0.474|<.0001
71119927|NCT02752958|141745536|OTHER||Mean Difference (Final Values)|1.28|||<|0.0001|TWO_SIDED|95.0|0.875|1.69|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 8||1.690|0.875|<.0001
71119928|NCT02752958|141745537|OTHER||Mean Difference (Final Values)|1.74|||<|0.0001|TWO_SIDED|95.0|1.333|2.145|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 12||2.145|1.333|<.0001
71119929|NCT02752958|141745538|OTHER||Mean Difference (Final Values)|1.96|||<|0.0001|TWO_SIDED|95.0|1.545|2.371|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 16||2.371|1.545|<.0001
71119930|NCT02752958|141745539|OTHER||Mean Difference (Final Values)|2.06|||<|0.0001|TWO_SIDED|95.0|1.643|2.469|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 20||2.469|1.643|<.0001
71119931|NCT02752958|141745540|OTHER||Mean Difference (Final Values)|2.21|||<|0.0001|TWO_SIDED|95.0|1.794|2.62||From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|ANOVA||Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24||2.620|1.794|<.0001
70854970|NCT02880956|141198369|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|0.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70943728|NCT01040403|141387601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.132|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.39|0.127|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.127|-0.390|
71119932|NCT02752958|141745541|OTHER||Mean Difference (Final Values)|1.18|||<|0.0001|TWO_SIDED|95.0|0.703|1.66|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 4||1.660|0.703|<0.0001
71119933|NCT02752958|141745542|OTHER||Mean Difference (Final Values)|1.45|||<|0.0001|TWO_SIDED|95.0|0.977|1.926|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 8||1.926|0.977|<.0001
71119934|NCT02752958|141745543|OTHER||Mean Difference (Final Values)|1.95|||<|0.0001|TWO_SIDED|95.0|1.473|2.418|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 12||2.418|1.473|<.0001
71119935|NCT02752958|141745544|OTHER||Mean Difference (Final Values)|2.33|||<|0.0001|TWO_SIDED|95.0|1.848|2.81|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week16||2.810|1.848|<.0001
71080907|NCT05052697|141668320|OTHER||Difference in percentage of participants|17.1|||||TWO_SIDED|95.0|-19.2|49.4|||||Difference in percentage of participants achieving seroconversion, qIRV group - Licensed QIV group as reference, expressed as a percentage.|Strain: A2||49.4|-19.2|
71080908|NCT05052697|141668320|OTHER||Difference in percentage of participants|-12.4|||||TWO_SIDED|95.0|-41.7|19.1|||||Difference in percentage of participants achieving seroconversion, qIRV group - Licensed QIV group as reference, expressed as a percentage.|Strain: B1||19.1|-41.7|
71119936|NCT02752958|141745545|OTHER||Mean Difference (Final Values)|2.21|||<|0.0001|TWO_SIDED|95.0|1.732|2.694|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 20||2.694|1.732|<.0001
70854971|NCT02880956|141198369|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.062||0.522|TWO_SIDED|95.0|-0.082|0.162||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|Week 48||0.162|-0.082|0.522
70943729|NCT01040403|141387601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.326|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.585|-0.067|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||-0.067|-0.585|
70943730|NCT01040403|141387601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|95.0|-0.01|0.511|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.511|-0.010|
71119937|NCT02752958|141745546|OTHER||Mean Difference (Final Values)|2.5|||<|0.0001|TWO_SIDED|95.0|2.02|2.982|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24||2.982|2.020|<.0001
71119938|NCT02752958|141745547|OTHER||Mean Difference (Final Values)|0.43||||0.0786|TWO_SIDED|95.0|-0.05|0.919|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 4||0.919|-0.050|0.0786
71119939|NCT02752958|141745548|OTHER||Mean Difference (Final Values)|0.69||||0.005|TWO_SIDED|95.0|0.21|1.171|||ANOVA|\[1\] From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 8||1.171|0.210|0.0050
71119940|NCT02752958|141745549|OTHER||Mean Difference (Final Values)|1.4|||<|0.0001|TWO_SIDED|95.0|0.918|1.875|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 12||1.875|0.918|<.0001
71119941|NCT02752958|141745550|OTHER||Mean Difference (Final Values)|1.44|||<|0.0001|TWO_SIDED|95.0|0.951|1.926|||ANOVA|\[From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|||1.926|0.951|<.0001
70854972|NCT02880956|141198369|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|0.41|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70943731|NCT01040403|141387601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.202|0.314|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.314|-0.202|
70943732|NCT01040403|141387601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.194|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.453|0.065|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.065|-0.453|
71080909|NCT05052697|141668320|OTHER||Difference in percentage of participants|1.4|||||TWO_SIDED|95.0|-29.2|32.5|||||Difference in percentage of participants achieving seroconversion, qIRV group - Licensed QIV group as reference, expressed as a percentage.|Strain: B2||32.5|-29.2|
71080910|NCT01289574|141668339|SUPERIORITY_OR_OTHER|||||||0.1919|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) row mean score statistics, adjusting for investigational site||||||0.1919
71080911|NCT01289574|141668340|SUPERIORITY_OR_OTHER|||||||0.061|||||||Cochran-Mantel-Haenszel|||||||0.0610
71080912|NCT01289574|141668341|SUPERIORITY_OR_OTHER|||||||0.0857|||||||Cochran-Mantel-Haenszel|||||||0.0857
71080913|NCT01554163|141668365|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Etoricoxib 30 mg will be considered non-inferior to celecoxib 200 mg if the upper bound of the two-sided 95% confidence interval of the betweentreatment difference in LS mean time-weighted average change from baseline over 12 weeks in WOMAC Pain Subscale (VAS) is no greater than 10 mm (non-inferiority margin).|Difference in LS Mean Change|-1.63||||0.39|TWO_SIDED|95.0|-5.37|2.1|||ANCOVA|||||2.10|-5.37|0.390
71119942|NCT02752958|141745551|OTHER||Mean Difference (Final Values)|1.17|||<|0.0001|TWO_SIDED|95.0|0.678|1.653||From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|ANOVA||Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 20||1.653|0.678|<.0001
71119943|NCT02752958|141745552|OTHER||Mean Difference (Final Values)|1.56|||<|0.0001|TWO_SIDED|95.0|1.072|2.047|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|||2.047|1.072|<.0001
70943733|NCT02973477|141387604|OTHER|Mixed effects model|Coefficient|0.28||||0.28|TWO_SIDED|95.0|-0.24|0.8||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome.|Mixed Models Analysis||The outcome was logged in the model. The outcome was the natural log of that variable and the coefficient and CI are for the relationship with the log of the outcome.|This is the adjusted mixed models analysis for both periods, both arms, comparing each treatment's change.||0.8|-0.24|0.28
71080914|NCT01554163|141668366|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Etoricoxib 30 mg will be considered non-inferior to celecoxib 200 mg if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in LS means (etoricoxib minus celecoxib) is no greater than 10 mm.|Difference in LS Mean Change|-1.32||||0.464|TWO_SIDED|95.0|-4.88|2.23|||ANCOVA|||||2.23|-4.88|0.464
71119944|NCT00977938|141745578|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||<|0.001|TWO_SIDED|95.0|0.59|0.85||P-value was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine received at the time of randomization, and presence or absence of risk factors for ST; P-value was adjudsted using the Benjamini Hochberg approach.|Log Rank||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.|The primary efficacy analysis was a superiority analysis. We controlled the two-sided family-wise error rate of 0.05 across the two coprimary end points using the Hochberg-Benjamini method. With this method, the null hypothesis of randomized treatment equivalence is rejected if significance is achieved for both end points at a two-sided alpha level of 0.05 or for one end point at a two-sided alpha level of 0.025.||0.85|0.59|<0.001
71119945|NCT00977938|141745579|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29|||<|0.001|TWO_SIDED|95.0|0.17|0.48||P-value was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine received at the time of randomization, and presence or absence of risk factors for ST; P-value was adjudsted using the Benjamini Hochberg approach.|Log Rank||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.|The primary efficacy analysis was a superiority analysis. We controlled the two-sided family-wise error rate of 0.05 across the two coprimary end points using the Hochberg-Benjamini method. With this method, the null hypothesis of randomized treatment equivalence is rejected if significance is achieved for both end points at a two-sided alpha level of 0.05 or for one end point at a two-sided alpha level of 0.025.||0.48|0.17|<0.001
71119946|NCT00977938|141745580|NON_INFERIORITY_OR_EQUIVALENCE|The primary safety analysis was a noninferiority analysis performed with the use of the Farrington-Manning risk-difference approach. Assuming an annualized rate for moderate or severe bleeding of 1.9% and an absolute noninferiority margin of 0.8%, at a one-sided alpha level of significance of 0.025, we calculated that a sample size of 9960 patients would give the study 80% power to detect noninferiority.|Risk Difference (RD)|0.96||||0.704|TWO_SIDED|95.0|0.38|1.53||One-sided P-value for non-inferiority|Farrington-Manning||30-month DAPT vs. 12-month DAPT|||1.53|0.38|0.704
71119947|NCT00977938|141745581|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 2.28% (0.0228)|Risk Difference (RD)|-1.82|||<|0.001|ONE_SIDED|97.5||0.03||One-sided P-value for non-inferiority|Nam and Kwon|P-value was computed for clustered matched pairs based on Nam and Kwon (2009).|Weighted RD and 1-sided 97.5% upper CL were computed for clustered matched pairs based on Nam and Kwon (2009).|The null hypothesis was that DAPT patients treated with DES would have MACCE rate between 0 and 33 months post-index procedure that exceeds that of the control arm (patients treated with BMS) by at least a pre-specified absolute margin of δ.||0.03||<0.001
71119948|NCT00977938|141745582|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.97% (0.0097)|Risk Difference (RD)|-1.05|||<|0.001|ONE_SIDED|97.5||-0.27||One-sided P-value for non-inferiority|Nam and Kwon|P-value was computed for clustered matched pairs based on Nam and Kwon (2009).|Weighted RD and 1-sided 95% upper CL were computed for clustered matched pairs based on Nam and Kwon (2009).|The null hypothesis was that DAPT patients treated with DES would have stent thrombosis rate between 0 and 33 months post-index procedure that exceeds that of the control arm (patients treated with BMS) by at least a pre-specified absolute margin of δ.||-0.27||<0.001
71119949|NCT00977938|141745583|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.7|0.97|||||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis|||0.97|0.70|
71119950|NCT00977938|141745584|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.29|0.69|||||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis|||0.69|0.29|
71119951|NCT00977938|141745585|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.86|||||TWO_SIDED|95.0|0.24|1.48|||||30-month DAPT vs. 12-month DAPT|||1.48|0.24|
71080915|NCT01554163|141668367|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Etoricoxib 30 mg will be considered non-inferior to celecoxib 200 mg if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in LS means (etoricoxib minus celecoxib) is no greater than 10 mm.|Difference in LS Mean Change|-1.09||||0.624|TWO_SIDED|95.0|-5.48|3.3|||ANCOVA|||||3.30|-5.48|0.624
71080916|NCT01554163|141668368|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean Change|-0.08||||0.369|TWO_SIDED|95.0|-0.26|0.1|||ANCOVA|||||0.10|-0.26|0.369
71080917|NCT01554163|141668369|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean Change|-0.09||||0.294|TWO_SIDED|95.0|-0.25|0.08|||ANCOVA|||||0.08|-0.25|0.294
71080918|NCT01554163|141668370|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean Change|-0.86||||0.679|TWO_SIDED|95.0|-4.96|3.24|||ANCOVA|||||3.24|-4.96|0.679
71080919|NCT01554163|141668371|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean Change|-0.1||||0.314|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||||0.10|-0.30|0.314
71080920|NCT01972464|141668380|SUPERIORITY||Odds Ratio (OR)|1.77||||0.39|TWO_SIDED|95.0|0.48|6.52||a priori threshold for statistical significance = 0.05|Regression, Logistic|adjusted for age (18-25 years versus \>25 years) and pre-quit smoking level (\<10 versus \>10 cigarettes per day)|OR represents of odds of abstinence in progesterone group versus placebo group|Null hypothesis- odds of week 8 point prevalence abstinence were equal between placebo and progesterone group.||6.52|0.48|0.39
71080921|NCT01972464|141668381|SUPERIORITY||Hazard Ratio (HR)|1.39||||0.41|TWO_SIDED|95.0|0.66|3.38||a priori threshold = 0.05|Regression, Cox|Adjusted for age and pre-quit smoking level|Hazard ratio is placebo / progesterone|||3.38|0.66|0.41
71080922|NCT01972464|141668382|SUPERIORITY||Risk Ratio (RR)|0.91|||<|0.001|TWO_SIDED|95.0|0.86|0.96|||general estimating equation|adjusted for age \& pre-quit smoking level; specified a gamma distribution, log link, autoregressive correlation structure|risk ratio is progesterone versus placebo|null hypothesis rate of change in QSU-brief scores were equal between treatment groups||0.96|0.86|<0.001
71080923|NCT02526160|141668383|SUPERIORITY||||||<|0.0001||||||From Cochran-Mantel-Haenszel (CMH) testing for association between achieving mean serum phosphorus levels above lower limit of normal (LLN) and treatment group, adjusting for stratification of Brief Pain Inventory (BPI) Average Pain and region.|Cochran-Mantel-Haenszel|||||||< 0.0001
71119952|NCT00977938|141745586|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.722|TWO_SIDED|95.0|0.57|1.47||This analysis was not powered. P-value was stratified according to geographic region, thienopyridine received at the time of randomization, and presence or absence of risk factors for ST; P-value was adjudsted using the Benjamini Hochberg approach.|Log Rank||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.|This analysis was not powered.||1.47|0.57|0.722
70854973|NCT02880956|141198369|SUPERIORITY||LS Mean of Difference|0.09|STANDARD_ERROR_OF_MEAN|0.064||0.147|TWO_SIDED|95.0|-0.033|0.219||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.219|-0.033|0.147
71080924|NCT02526160|141668384|SUPERIORITY||Least squares (LS) mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.275||0.0919|TWO_SIDED|95.0|-1.0|0.08||Prespecified significance level for test after Hochberg adjustment: 0.05|GEE model|||||0.08|-1.00|0.0919
71080925|NCT02526160|141668385|SUPERIORITY||LS mean difference|-8.31|STANDARD_ERROR_OF_MEAN|3.251||0.0106|TWO_SIDED|95.0|-14.68|-1.94||Prespecified significance level for test after Hochberg adjustment: 0.0167|GEE model|||||-1.94|-14.68|0.0106
71080926|NCT02526160|141668386|SUPERIORITY||LS mean difference|-4.9|STANDARD_ERROR_OF_MEAN|2.479||0.0478|TWO_SIDED|95.0|-9.76|-0.05||Prespecified significance level for test after Hochberg adjustment: 0.025|GEE model|||||-0.05|-9.76|0.0478
71080927|NCT02576977|141668416|SUPERIORITY||Hazard Ratio (HR)|1.5||||0.99324|TWO_SIDED|95.0|1.08|2.08|||Log Rank|One-sided p-value based on Stratified log-rank test.|Based on Cox regression model with treatment as a covariate stratified by disease status (refractory vs. sensitive to Lenalidomide) and Lines of previous treatments (two vs. three or more).|||2.08|1.08|0.99324
71080928|NCT02576977|141668417|SUPERIORITY||Hazard Ratio (HR)|1.84||||0.99989|TWO_SIDED|95.0|1.32|2.55|||Log Rank|One-sided p-value based on Stratified log-rank test.|||The Hazard Ratio and 95% confidence intervals were based on Cox regression model with treatment as a covariate stratified by disease status (refractory vs. sensitive to Lenalidomide) and Lines of previous treatments (two vs. three or more).|2.55|1.32|0.99989
71080929|NCT02576977|141668418|SUPERIORITY||Difference in % vs. SOC|-5.2||||0.79921|TWO_SIDED|95.0|-17.1|6.9|||Miettinen & Nurminen method||||Based on Miettinen \& Nurminen method stratified by disease status (refractory vs. sensitive to Lenalidomide) and Lines of previous treatments (two vs. three or more); If there were no participants in one of the treatment groups involved in a comparison for a particular stratum, then that stratum was excluded from the treatment comparison.|6.9|-17.1|0.79921
71080930|NCT04304508|141668435|OTHER|Dose-response test by using multiple comparison procedures (MCP) Mod.||||||0.7976|||||||MCP Mod|||Dose-response test||||0.7976
71080931|NCT04304508|141668435|OTHER||Crude incidence ratio|1.044|||||TWO_SIDED|90.0|0.8105|1.3478||||||Comparison of the Asundexian 10 mg group versus Placebo group.||1.3478|0.8105|
71080932|NCT04304508|141668435|OTHER||Crude incidence ratio|1.1963|||||TWO_SIDED|90.0|0.9281|1.5428||||||Comparison of the Asundexian 20 mg group versus Placebo group.||1.5428|0.9281|
71080933|NCT04304508|141668435|OTHER||Crude incidence ratio|1.0485|||||TWO_SIDED|90.0|0.8082|1.3619||||||Comparison of the Asundexian 50 mg group versus Placebo group.||1.3619|0.8082|
71080934|NCT04304508|141668443|OTHER|Cause specific HRs were only calculated if at least 3 events occurred in 1 of the compared groups and at least 1 event in each of the compared treatment groups.|Cox Proportional Hazard|1.724|||=|0.1507|TWO_SIDED|90.0|0.924|3.215|||Log Rank|||Comparison of the Asundexian 10 mg group versus Placebo group||3.215|0.924|= 0.1507
71080935|NCT04304508|141668443|OTHER|Cause specific HRs were only calculated if at least 3 events occurred in 1 of the compared groups and at least 1 event in each of the compared treatment groups.|Cox Proportional Hazard|1.285|||=|0.5339|TWO_SIDED|90.0|0.662|2.494|||Log Rank|||Comparison of the Asundexian 20 mg group versus Placebo group||2.494|0.662|= 0.5339
71080936|NCT04304508|141668443|OTHER|Cause specific HRs were only calculated if at least 3 events occurred in 1 of the compared groups and at least 1 event in each of the compared treatment groups.|Cox Proportional Hazard|1.749|||=|0.1401|TWO_SIDED|90.0|0.938|3.262|||Log Rank|||Comparison of the Asundexian 50 mg group versus Placebo group||3.262|0.938|= 0.1401
71080937|NCT04304508|141668443|OTHER|Cause specific HRs were only calculated if at least 3 events occurred in 1 of the compared groups and at least 1 event in each of the compared treatment groups.|Cox Proportional Hazard|1.585|||=|0.1653|TWO_SIDED|90.0|0.918|2.736|||Log Rank|||Comparison of the Total Asundexian group versus Placebo group||2.736|0.918|= 0.1653
70854974|NCT02880956|141198369|SUPERIORITY||Effect size/pooled SD|-0.17|STANDARD_DEVIATION|0.53|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70854975|NCT02880956|141198369|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.091||0.492|TWO_SIDED|95.0|-0.243|0.117||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.117|-0.243|0.492
70943734|NCT02973477|141387605|OTHER||Coefficient|-0.003||||0.97|TWO_SIDED|95.0|-0.16|0.15||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome.|Mixed Models Analysis||The outcome was logged in the model. The outcome was the natural log of that variable and the coefficient and CI are for the relationship with the log of the outcome.|This is the adjusted analysis to compare the difference between the values from baseline to 12 weeks between each intervention for SDNN.||0.15|-0.16|0.97
70854976|NCT02880956|141198369|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|0.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70854977|NCT02880956|141198369|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.09||0.691|TWO_SIDED|95.0|-0.213|0.141||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.141|-0.213|0.691
71119953|NCT00977938|141745587|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49||||0.478|TWO_SIDED|95.0|0.15|1.64||This analysis was not powered. P-value was stratified according to geographic region, thienopyridine received at the time of randomization, and presence or absence of risk factors for ST; P-value was adjudsted using the Benjamini Hochberg approach.|Log Rank||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.|This analysis was not powered.||1.64|0.15|0.478
71119954|NCT00977938|141745588|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.12||||0.706|TWO_SIDED|95.0|-0.06|2.31|||Farrington-Manning|No formal hypothesis testing was done.|30-month DAPT vs. 12-month DAPT|||2.31|-0.06|0.706
71119955|NCT00977938|141745589|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.58|1.4|||||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis|||1.40|0.58|
71119956|NCT00977938|141745590|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||||TWO_SIDED|95.0|0.15|1.64|||||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.|||1.64|0.15|
71119957|NCT00977938|141745591|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.03|||||TWO_SIDED|95.0|-0.21|2.28|||||30-month DAPT vs. 12-month DAPT|||2.28|-0.21|
71119958|NCT03373890|141745592|OTHER|Independent samples Mann Whitney U||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||.39
71119959|NCT03373890|141745593|OTHER|Independent samples Mann Whitney U||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||.39
71119960|NCT03373890|141745594|OTHER|Independent samples Mann Whitney U||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||.03
71119961|NCT03373890|141745595|OTHER|Independent samples Mann Whitney U||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||.39
71119962|NCT03373890|141745596|OTHER|Independent samples Mann Whitney U||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||.06
71119963|NCT03373890|141745597|OTHER|Independent samples Mann Whitney U||||||0.99|||||||Wilcoxon (Mann-Whitney)|||||||.99
71119964|NCT03373890|141745598|OTHER|LInear mixed model||||||0.008|||||||Regression, Logistic|||||||.008
71119965|NCT03373890|141745599|OTHER|Linear mixed model regression||||||0.34|||||||Regression, Linear|||||||.34
70854978|NCT02880956|141198369|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|0.6|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71119966|NCT00355342|141745648|EQUIVALENCE|The null hypothesis for the primary measure is that the difference between the effects of fluticasone propionate/salmeterol combination product 250/50mcg BID and salmeterol 50mcg BID on the change in BMD assessed at the L1-L4 region of the spine is greater than 1 %/year.|Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|0.06|1.49|||||Analysis Model: Percent change from baseline BMD = treatment + time (years) + treatment\*time + baseline BMD + sex + investigator + age + BMI + FEV1 severity + b/l activity level + b/l calcium supp. use + smoking status.|The analysis is presented for slope estimate calculated for the percent change from Baseline values at Week 26, 52, 78, 104, 130, and 156.|Age split by category (40-64 years old, 65 or older). FEV1 severity based on GOLD Stage (Mild/Moderate, Severe/Very Severe). Activity based on 0-10 Physical Activity Scale (split by median, \<7, \>=7). Slope estimates based on treatment\*time via repeated measures model with unstructured covariance.|1.49|0.06|
71119967|NCT00355342|141745649|EQUIVALENCE|The null hypothesis for the primary measure is that the difference between the effects of fluticasone propionate/salmeterol combination product 250/50mcg BID and salmeterol 50mcg BID on the change in BMD assessed at the L1-L4 region of the spine is greater than 1 %/year.|Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.78|0.24|||||Analysis Model: Percent change from baseline BMD = treatment + time (years) + treatment\*time + baseline BMD + sex + investigator + age + BMI + FEV1 severity + b/l activity level + b/l calcium supp. use + smoking status|The analysis is presented for slope estimate calculated for the percent change from Baseline values at Week 26, 52, 78, 104, 130, and 156.|Age split by category (40-64 years old, 65 or older). FEV1 severity based on GOLD Stage (Mild/Moderate, Severe/Very Severe). Activity based on 0-10 Physical Activity Scale (split by median, \<7, \>=7). Slope estimates based on treatment\*time via repeated measures model with unstructured covariance.|0.24|-0.78|
71119968|NCT00953680|141745692|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|0.993||||||90.0|0.95|1.039||||||Least-Squares Mean Ratio (A/B); A= Single dose losartan 100 mg-HCTZ 12.5 mg combination tablet; B= Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule||1.039|0.950|
71119969|NCT00953680|141745693|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|0.835||||||90.0|0.749|0.931||||||Least-Squares Mean Ratio (A/B); A= Single dose losartan 100 mg-HCTZ 12.5 mg combination tablet; B= Single dose losartan 100-mg tablet + HCTZ 12.5 mg capsule||0.931|0.749|
71119970|NCT00953680|141745694|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|0.924||||||90.0|0.825|1.035||||||Least-Squares Mean Ratio (A/B); A= Single dose losartan 100 mg-HCTZ 12.5 mg combination tablet; B= Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule||1.035|0.825|
71119971|NCT00953680|141745695|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|0.931||||||90.0|0.836|1.037||||||Least-Squares Mean Ratio (A/B); A= Single dose losartan 100 mg-HCTZ 12.5 mg combination tablet; B= Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule||1.037|0.836|
71080938|NCT02688764|141668449|SUPERIORITY|||||||0.1465||||||0.05 level of significance|t-test, 2 sided|||Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects.||||0.1465
71119972|NCT01514240|141745763|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 90% CI for the observed difference in the primary outcome measure (remission rate) between the D9421-C 9mg group and the Mesalazine 3 g group was calculated at week 8 using the Newcombe-Wilson score method without continuity correction. Noninferiority was concluded if the lower limit of the 90% CI was higher than -10% in FAS Population.|Difference of proportion|5.4||||0.526|TWO_SIDED|90.0|-8.49|18.94|||Chi-squared|||The primary objective of this study was to determine non-inferiority in the differences in remission rates at Week 8 for D9421-C 9 mg as compared to Mesalazine 3 g.||18.94|-8.49|0.526
71119973|NCT01514240|141745764|SUPERIORITY_OR_OTHER||Difference of proportion|1.8||||0.768|TWO_SIDED|90.0|-8.54|12.15|||Chi-squared||Differences in remission rate at Week 2 between D9421-C 9 mg and Mesalazine 3 g along with their 2-sided 90% CIs calculated by the Newcombe-Wilson score method without continuity correction|||12.15|-8.54|0.768
71119974|NCT01514240|141745765|SUPERIORITY_OR_OTHER||Difference of proportion|8.9||||0.208|TWO_SIDED|90.0|-2.87|20.58|||Chi-squared||Differences in remission rate at Week 4 between D9421-C 9 mg and Mesalazine 3 g along with their 2-sided 90% CIs calculated by the Newcombe-Wilson score method without continuity correction|||20.58|-2.87|0.208
71119975|NCT01514240|141745766|SUPERIORITY_OR_OTHER||LS mean difference between group|-22.8|STANDARD_ERROR_OF_MEAN|11.89||0.058|TWO_SIDED|90.0|-42.55|-3.09|||Mixed Models Analysis||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||-3.09|-42.55|0.058
71119976|NCT01514240|141745767|SUPERIORITY_OR_OTHER||LS mean difference between group|-30.0|STANDARD_ERROR_OF_MEAN|12.05||0.014|TWO_SIDED|90.0|-49.95|-9.96|||Mixed Models Analysis||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||-9.96|-49.95|0.014
71119977|NCT01514240|141745768|SUPERIORITY_OR_OTHER||LS mean difference between group|-21.4|STANDARD_ERROR_OF_MEAN|14.53||0.144|TWO_SIDED|90.0|-45.47|2.74|||Mixed Models Analysis||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||2.74|-45.47|0.144
71119978|NCT01514240|141745772|SUPERIORITY_OR_OTHER||Difference of proportions|14.3|||||TWO_SIDED|90.0|0.5|27.4|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.|||27.40|0.50|
71119979|NCT01514240|141745773|SUPERIORITY_OR_OTHER||Difference of proportions|16.1|||||TWO_SIDED|90.0|1.66|29.61|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.|||29.61|1.66|
71119980|NCT01514240|141745774|SUPERIORITY_OR_OTHER||Difference of proportions|16.1|||||TWO_SIDED|90.0|0.85|30.29|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.|||30.29|0.85|
70943735|NCT02973477|141387605|OTHER||Coefficient|-0.02||||0.79|TWO_SIDED|95.0|-0.21|0.16||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome.|Mixed Models Analysis||The outcome was logged in the model. The outcome was the natural log of that variable and the coefficient and CI are for the relationship with the log of the outcome.|This is the adjusted analysis to compare the difference between the values from baseline to 12 weeks between each intervention for rmsSD.||0.16|-0.21|0.79
71119981|NCT01514240|141745775|SUPERIORITY_OR_OTHER||Difference of proportions|7.1|||||TWO_SIDED|90.0|-5.67|19.71|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.|||19.71|-5.67|
71119982|NCT01514240|141745776|SUPERIORITY_OR_OTHER||Difference of proportions|14.3|||||TWO_SIDED|90.0|0.5|27.4|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.|||27.40|0.50|
71119983|NCT01514240|141745777|SUPERIORITY_OR_OTHER||Difference of proportions|12.5|||||TWO_SIDED|90.0|-2.44|26.68|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.|||26.68|-2.44|
71119984|NCT01514240|141745778|SUPERIORITY_OR_OTHER||LS mean difference between group|10.5|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|90.0|4.86|16.14|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||16.14|4.86|
71119985|NCT01514240|141745779|SUPERIORITY_OR_OTHER||LS mean difference between group|12.6|STANDARD_ERROR_OF_MEAN|3.93|||TWO_SIDED|90.0|6.07|19.11|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||19.11|6.07|
71119986|NCT01514240|141745780|SUPERIORITY_OR_OTHER||LS mean difference between group|12.6|STANDARD_ERROR_OF_MEAN|4.31|||TWO_SIDED|90.0|5.4|19.72|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||19.72|5.40|
71119987|NCT01514240|141745781|SUPERIORITY_OR_OTHER||LS mean difference between group|14.1|STANDARD_ERROR_OF_MEAN|4.32|||TWO_SIDED|90.0|6.9|21.23|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||21.23|6.90|
71119988|NCT01514240|141745782|SUPERIORITY_OR_OTHER||LS mean difference between group|3.4|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|1.49|5.29|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||5.29|1.49|
71080939|NCT02688764|141668452|SUPERIORITY|||||||0.0872||||||0.05 level of significance|t-test, 2 sided|||Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects||||0.0872
70854979|NCT02880956|141198369|SUPERIORITY||LS Mean of Difference|0.14|STANDARD_ERROR_OF_MEAN|0.091||0.135|TWO_SIDED|95.0|-0.043|0.317||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.317|-0.043|0.135
70854980|NCT02880956|141198369|SUPERIORITY||Effect size/pooled SD|-0.19|STANDARD_DEVIATION|0.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70854981|NCT02880956|141198369|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.117||0.713|TWO_SIDED|95.0|-0.273|0.187||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.187|-0.273|0.713
70943736|NCT02973477|141387606|OTHER||Coefficient|0.01||||0.58|TWO_SIDED|95.0|-0.02|0.04||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome.|Mixed Models Analysis|||This is the adjusted analysis for both periods, both arms, comparing each treatment's change of EI ratio.||0.04|-0.02|0.58
70854982|NCT02880956|141198369|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70854983|NCT02880956|141198369|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.115||0.318|TWO_SIDED|95.0|-0.341|0.111||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.111|-0.341|0.318
70854984|NCT02880956|141198369|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|0.8|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70854985|NCT02880956|141198369|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.119||0.927|TWO_SIDED|95.0|-0.244|0.222||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.222|-0.244|0.927
70854986|NCT02880956|141198369|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|0.84|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70943737|NCT02973477|141387606|OTHER||Coefficient|0.02||||0.58|TWO_SIDED|95.0|-0.05|0.09||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome. Coefficient provided for Valsalva ratio.|Mixed Models Analysis||The outcome was logged in the model. The outcome was the natural log of that variable and the coefficient and CI are for the relationship with the log of the outcome.|This is the adjusted analysis for both periods, both arms, comparing each treatment's change of Valsalva ratio.||0.09|-0.05|0.58
70943738|NCT02973477|141387606|OTHER||Coefficient|-0.01||||0.56|TWO_SIDED|95.0|-0.05|0.03||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome. Coefficient provided for 30:15 ratio.|Mixed Models Analysis|||This is the adjusted analysis for both periods, both arms, comparing each treatment's change of 30:15 ratio.||0.03|-0.05|0.56
70943739|NCT02973477|141387607|OTHER||Coefficient|0.01||||0.92|TWO_SIDED|95.0|-0.23|0.25||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome.|Mixed Models Analysis|||This is the adjusted analysis for both periods, both arms, comparing each treatment's change of BNP.||0.25|-0.23|0.92
70943740|NCT03036150|141387612|SUPERIORITY||Hazard Ratio (HR)|0.61|||<|0.0001||95.0|0.51|0.72|||Regression, Cox|Stratified by randomization stratification of Type 2 Diabetes and urine albumin creatinine ratio and adjusting for baseline eGFR.||||0.72|0.51|< 0.0001
70943741|NCT03036150|141387613|SUPERIORITY||Hazard Ratio (HR)|0.56|||<|0.0001||95.0|0.45|0.68|||Regression, Cox|Stratified by randomization stratification of Type 2 Diabetes and urine albumin creatinine ratio and adjusting for baseline eGFR.||||0.68|0.45|< 0.0001
70943742|NCT03036150|141387614|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0089||95.0|0.55|0.92|||Regression, Cox|Stratified by randomization stratification of Type 2 Diabetes and urine albumin creatinine ratio and adjusting for baseline eGFR.||||0.92|0.55|0.0089
70943743|NCT03036150|141387615|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0035||95.0|0.53|0.88|||Regression, Cox|Stratified by randomization stratification of Type 2 Diabetes and urine albumin creatinine ratio and adjusting for baseline eGFR.||||0.88|0.53|0.0035
70854987|NCT02880956|141198370|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.081||0.456|TWO_SIDED|95.0|-0.219|0.098||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.098|-0.219|0.456
70854988|NCT02880956|141198370|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|0.64|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70943744|NCT02487251|141387626|EQUIVALENCE|Phase 1 sought to determine effect sizes. For Phase 2, sample size was set at 125 per arm which, with 20% attrition, would enable detection of small to medium effect sizes of d = 0.40SD for continuous outcomes and 38% relative risk reduction for binary outcomes with a power of 80% and α = .05.|Mean Difference (Final Values)|-0.15||||0.34|TWO_SIDED|||||p \< .05 reflects the threshold for statistical significance. The calculated p value for change in BMIz is p = .34.|Mixed Models Analysis||The reported estimation parameter is the effect size (cohen's d) for the change in BMIz (particularly in the Phase 2 sample)|We tested change in BMIz for each of the four study arms/groups.||||.34
70943745|NCT02487251|141387627|EQUIVALENCE|Sample size was set at 125 per arm which, with 20% attrition, would enable detection of small to medium effect sizes of d = 0.40SD for continuous outcomes and 38% relative risk reduction for binary outcomes with a power of 80% and α = .05. Phase 2 analyses included mixed modeling. Negative mean change values reflect a decrease in intake; positive values reflect an increase.|Mean Difference (Final Values)|-0.07||||0.62|TWO_SIDED|||||p \< .05 reflects the threshold for statistical significance. The calculated p value for change in observed fruit intake is p = .62.|Mixed Models Analysis||The reported estimation parameter is a standardized mean difference between the groups, specifically cohen's d.|We tested change in observed fruit intake for each of the two study arms/groups in Phase 2 and compared change between the usual care and intervention groups.||||.62
70854989|NCT02880956|141198370|SUPERIORITY||LS Mean of Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.079||0.093|TWO_SIDED|95.0|-0.29|0.023||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.023|-0.290|0.093
70854990|NCT02880956|141198370|SUPERIORITY||Effect size/pooled SD|0.23|STANDARD_DEVIATION|0.59|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70854991|NCT02880956|141198370|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.082||0.75|TWO_SIDED|95.0|-0.187|0.135||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.135|-0.187|0.750
70854992|NCT02880956|141198370|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|0.63|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70854993|NCT02880956|141198370|SUPERIORITY||LS Mean of Difference|0.16|STANDARD_ERROR_OF_MEAN|0.106||0.134|TWO_SIDED|95.0|-0.049|0.366||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.366|-0.049|0.134
70954242|NCT00688870|141411076|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|4.79|||||TWO_SIDED|95.0|3.78|6.08|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 5||6.08|3.78|
71119989|NCT01514240|141745783|SUPERIORITY_OR_OTHER||LS mean difference between group|3.8|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|90.0|1.64|5.97|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||5.97|1.64|
71119990|NCT01514240|141745784|SUPERIORITY_OR_OTHER||LS mean difference between group|4.1|STANDARD_ERROR_OF_MEAN|1.53|||TWO_SIDED|90.0|1.58|6.64|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||6.64|1.58|
71119991|NCT01514240|141745785|SUPERIORITY_OR_OTHER||LS mean difference between group|3.3|STANDARD_ERROR_OF_MEAN|1.47|||TWO_SIDED|90.0|0.9|5.76|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||5.76|0.90|
71119992|NCT01514240|141745786|SUPERIORITY_OR_OTHER||LS mean difference between group|2.0|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|90.0|0.89|3.17|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||3.17|0.89|
71119993|NCT01514240|141745787|SUPERIORITY_OR_OTHER||LS mean difference between group|2.0|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|90.0|0.73|3.19|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||3.19|0.73|
71119994|NCT01514240|141745788|SUPERIORITY_OR_OTHER||LS mean difference between group|2.4|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|90.0|0.96|3.76|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||3.76|0.96|
71119995|NCT01514240|141745789|SUPERIORITY_OR_OTHER||LS mean difference between group|2.6|STANDARD_ERROR_OF_MEAN|0.89|||TWO_SIDED|90.0|1.15|4.09|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||4.09|1.15|
71119996|NCT01514240|141745790|SUPERIORITY_OR_OTHER||LS mean difference between group|3.8|STANDARD_ERROR_OF_MEAN|1.43|||TWO_SIDED|90.0|1.44|6.19|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||6.19|1.44|
71119997|NCT01514240|141745791|SUPERIORITY_OR_OTHER||LS mean difference between group|4.9|STANDARD_ERROR_OF_MEAN|1.66|||TWO_SIDED|90.0|2.14|7.65|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||7.65|2.14|
71119998|NCT01514240|141745792|SUPERIORITY_OR_OTHER||LS mean difference between group|4.3|STANDARD_ERROR_OF_MEAN|1.76|||TWO_SIDED|90.0|1.4|7.25|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||7.25|1.40|
71119999|NCT01514240|141745793|SUPERIORITY_OR_OTHER||LS mean difference between group|6.6|STANDARD_ERROR_OF_MEAN|1.86|||TWO_SIDED|90.0|3.56|9.72|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||9.72|3.56|
71120000|NCT01514240|141745794|SUPERIORITY_OR_OTHER||LS mean difference between group|1.2|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|90.0|0.01|2.43|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||2.43|0.01|
71120001|NCT01514240|141745795|SUPERIORITY_OR_OTHER||LS mean difference between group|1.8|STANDARD_ERROR_OF_MEAN|0.81|||TWO_SIDED|90.0|0.42|3.12|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||3.12|0.42|
71120002|NCT01514240|141745796|SUPERIORITY_OR_OTHER||LS mean difference between group|1.6|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|90.0|0.19|3.04|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||3.04|0.19|
71120003|NCT01514240|141745797|SUPERIORITY_OR_OTHER||LS mean difference between group|1.3|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|90.0|-0.15|2.76|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||2.76|-0.15|
71120004|NCT00450294|141745798|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||That the means at the different timepoints would not all be equal.|ANOVA|||Repeated measures anova with post hoc t-tests using tukey's correction.||||<0.001
71120005|NCT00450294|141745799|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||That the means at the different timepoints would not all be equal.|ANOVA|||Repeated measures anova with post hoc t-tests using tukey's correction.||||<0.001
71120006|NCT01007123|141745809|SUPERIORITY_OR_OTHER||||||<|0.2|TWO_SIDED|0.0|||||ANCOVA|||||||<0.2
70854994|NCT02880956|141198370|SUPERIORITY||Effect size/pooled SD|-0.2|STANDARD_DEVIATION|0.79|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70854995|NCT02880956|141198370|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.103||0.316|TWO_SIDED|95.0|-0.099|0.305||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.305|-0.099|0.316
71120007|NCT01007123|141745809|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|0.0|||||ANCOVA|||||||0.002
71120008|NCT01007123|141745809|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|0.0|||||ANCOVA|||||||<0.001
71120009|NCT01007123|141745810|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|0.0|||||Fisher Exact|||||||0.03
71120010|NCT01007123|141745810|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|0.0|||||Fisher Exact|||||||0.008
71120011|NCT01007123|141745810|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|0.0|||||Fisher Exact|||||||<0.001
71120012|NCT01007123|141745811|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED|0.0|||||Fisher Exact|||||||0.06
71120013|NCT01007123|141745811|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|0.0|||||Fisher Exact|||||||0.03
71120014|NCT01007123|141745811|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|0.0|||||Fisher Exact|||||||0.04
71120015|NCT01007123|141745812|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED|0.0|||||ANCOVA|||||||0.44
71120016|NCT01007123|141745812|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|0.0|||||ANCOVA|||||||<0.001
71120017|NCT01007123|141745812|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|0.0|||||ANCOVA|||||||<0.001
71120018|NCT01007123|141745813|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|0.0|||||ANCOVA|||Comparison vs placebo||||0.01
71120019|NCT01007123|141745813|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|0.0|||||ANCOVA|||Comparison vs placebo||||<0.05
71120020|NCT01007123|141745814|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|0.0|||||ANCOVA|||||||0.17
71120021|NCT01007123|141745814|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|0.0|||||ANCOVA|||||||<0.001
71120022|NCT01007123|141745814|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|0.0|||||ANCOVA|||||||<0.001
71120023|NCT00297102|141745816|SUPERIORITY_OR_OTHER||Mean Difference (Net)|39.0|STANDARD_ERROR_OF_MEAN|11.0||0.0003|TWO_SIDED|95.0|18.0|60.0||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).||||60|18|0.0003
71120024|NCT00297102|141745817|SUPERIORITY_OR_OTHER||Rate ratio|0.851|STANDARD_ERROR_OF_MEAN|0.062||0.0278|TWO_SIDED|95.0|0.737|0.982||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|Poisson regression|||||0.982|0.737|0.0278
71120025|NCT00297102|141745818|SUPERIORITY_OR_OTHER||Mean Difference (Net)|49.0|STANDARD_ERROR_OF_MEAN|11.0|<|0.0001|TWO_SIDED|95.0|26.0|71.0||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).||||71|26|<0.0001
71120026|NCT00297102|141745819|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.035|STANDARD_ERROR_OF_MEAN|0.357||0.9212|TWO_SIDED|95.0|0.526|2.034||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|Cox proportional hazards regression||The statistical analysis is based on the ITT Analysis Set (n= 765 in the roflumilast group, n= 758 in the placebo group).|||2.034|0.526|0.9212
71120027|NCT00297102|141745820|SUPERIORITY_OR_OTHER||Mean Difference calculated as ratio|0.9521||||0.4089|TWO_SIDED|95.0|0.8472|1.0699||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|ANCOVA model including last observation carried forward (LOCF) method||||1.0699|0.8472|0.4089
71120028|NCT00297102|141745821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.233|STANDARD_ERROR_OF_MEAN|0.111||0.0356|TWO_SIDED|95.0|0.016|0.449||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).||||0.449|0.016|0.0356
71120029|NCT00252694|141745830|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.1994|TWO_SIDED|95.0|0.704|1.076|||Log Rank|Generalized||||1.076|0.704|0.1994
71120030|NCT02868034|141745844|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.025|TWO_SIDED|97.5|-0.26|0.22|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in stiffness when the component was used|SMT Component Main Effects at 4 weeks||0.22|-0.26|0.025
71120031|NCT02868034|141745844|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.025|TWO_SIDED|97.5|-0.43|0.09|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in stiffness when the component was used|SMT Component Main Effects after 12 weeks||0.09|-0.43|0.025
71120032|NCT02868034|141745844|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.025|TWO_SIDED|97.5|-0.11|0.38|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in stiffness when the component was used|Mobilizing Exercise Treatment Component Main Effects at 4 weeks||0.38|-0.11|0.025
71120033|NCT02868034|141745844|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.025|TWO_SIDED|97.5|-0.23|0.29|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in stiffness when the component was used|Mobilizing Exercise Component Main Effects at 12 weeks||0.29|-0.23|0.025
71120034|NCT02868034|141745844|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.025|TWO_SIDED|97.5|-0.45|0.04|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in stiffness when the component was used|Activating Exercise Component Main Effect at 4 weeks||0.04|-0.45|0.025
70943746|NCT02487251|141387628|EQUIVALENCE|Sample size was set at 125 per arm which, with 20% attrition, would enable detection of small to medium effect sizes of d = 0.40SD for continuous outcomes and 38% relative risk reduction for binary outcomes with a power of 80% and α = .05.|Mean Difference (Final Values)|0.4||||0.009|TWO_SIDED|||||p \< .05 reflects the threshold for statistical significance. The calculated p value for change in observed vegetable intake is p = .009.|Mixed Models Analysis|||We tested pre to post change in observed vegetable intake for each of the two study arms/groups in Phase 2 and compared change between the usual care and intervention groups. Positive Observed dietary quality data was not collected in Phase 1.||||.009
71120035|NCT02868034|141745844|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.025|TWO_SIDED|97.5|-0.45|0.07|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater change when the component was used|Activating Exercise Component Main Effect at 12 weeks||0.07|-0.45|0.025
71120036|NCT02868034|141745844|SUPERIORITY||interaction relative mean difference|-0.17||||0.025|TWO_SIDED|97.5|-0.66|0.32|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 4 weeks||0.32|-0.66|0.025
71120037|NCT02868034|141745844|SUPERIORITY||interaction relative mean difference|-0.1||||0.025|TWO_SIDED|97.5|-0.62|0.42|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 12 weeks||0.42|-0.62|0.025
71120038|NCT02868034|141745844|SUPERIORITY||interaction relative mean difference|0.13||||0.025|TWO_SIDED|97.5|-0.36|0.62|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 4 weeks||0.62|-0.36|0.025
71120039|NCT02868034|141745844|SUPERIORITY||interaction relative mean difference|0.5||||0.025|TWO_SIDED|97.5|-0.02|1.02|||Mixed Models Analysis|||||1.02|-0.02|0.025
71120040|NCT02868034|141745844|SUPERIORITY||interaction relative mean difference|-0.17||||0.025|TWO_SIDED|97.5|-0.66|0.32|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 4 weeks||0.32|-0.66|0.025
71120041|NCT02868034|141745844|SUPERIORITY||interaction relative mean difference|0.39||||0.025|TWO_SIDED|97.5|-0.13|0.91|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 12 weeks||0.91|-0.13|0.025
71120042|NCT02868034|141745844|SUPERIORITY||3-way interaction relative mean dif.|0.25||||0.025|TWO_SIDED|97.5|-0.24|0.74|||Mixed Models Analysis|||Three-way interaction effect of SMT, activating exercise and mobilizing exercise components after 4 weeks||0.74|-0.24|0.025
71120043|NCT02868034|141745844|SUPERIORITY||3-way interaction relative mean dif.|0.4||||0.025|TWO_SIDED|97.5|-0.12|0.92|||Mixed Models Analysis|||Three-way interaction effect of SMT, activating exercise and mobilizing exercise components after 12 weeks||0.92|-0.12|0.025
71120044|NCT02868034|141745845|SUPERIORITY||Mean Difference (Final Values)|-0.57||||0.025|TWO_SIDED|97.5|-2.67|1.52|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.||SMT Component Main Effects at 4 weeks|A positive value indicates greater improvement in muscle activation when the component was used|1.52|-2.67|0.025
71120045|NCT02868034|141745845|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.025|TWO_SIDED|97.5|-2.76|2.02|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A positive value indicates greater improvement in muscle activation when the component was used|SMT Component Main Effects at 12 weeks||2.02|-2.76|0.025
71120046|NCT02868034|141745845|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.025|TWO_SIDED|97.5|-2.03|2.16|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A positive value indicates greater improvement in muscle activation when the component was used|Mobilizing Component Main Effects at 4 weeks||2.16|-2.03|0.025
71120047|NCT02868034|141745845|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.025|TWO_SIDED|97.5|-1.68|3.11|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A positive value indicates greater improvement in muscle activation when the component was used|Mobilizing Component Main Effects at 12 weeks||3.11|-1.68|0.025
71120048|NCT02868034|141745845|SUPERIORITY||Mean Difference (Final Values)|-0.85||||0.025|TWO_SIDED|97.5|-2.94|1.25|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A positive value indicates greater improvement in muscle activation when the component was used|Activating Exercise Component at 4 weeks||1.25|-2.94|0.025
71120049|NCT02868034|141745845|SUPERIORITY||Mean Difference (Final Values)|-0.57||||0.025|TWO_SIDED|97.5|-2.97|1.82|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A positive value indicates greater improvement in muscle activation when the component was used|Activating Exercise Component at 12 weeks||1.82|-2.97|0.025
71120050|NCT02868034|141745845|SUPERIORITY||interaction relative mean difference|0.8||||0.025|TWO_SIDED|97.5|-3.39|4.99|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 4 weeks||4.99|-3.39|0.025
71120051|NCT02868034|141745845|SUPERIORITY||interaction relative mean difference|-0.68||||0.025|TWO_SIDED|97.5|-5.47|4.11|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 12 weeks||4.11|-5.47|0.025
70854996|NCT02880956|141198370|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|0.72|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70854997|NCT02880956|141198370|SUPERIORITY||LS Mean of Difference|0.13|STANDARD_ERROR_OF_MEAN|0.106||0.218|TWO_SIDED|95.0|-0.078|0.339||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.339|-0.078|0.218
71080940|NCT02688764|141668453|SUPERIORITY|||||||0.6207||||||0.05 level of significance|t-test, 2 sided|||Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 2 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects.||||0.6207
71120052|NCT02868034|141745845|SUPERIORITY||interaction relative mean difference|-1.56||||0.025|TWO_SIDED|97.5|-5.75|2.63|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 4 weeks||2.63|-5.75|0.025
71120053|NCT02868034|141745845|SUPERIORITY||interaction relative mean difference|1.42||||0.025|TWO_SIDED|97.5|-3.37|6.21|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 12 weeks||6.21|-3.37|0.025
71080941|NCT02688764|141668453|SUPERIORITY|||||||0.3226||||||0.05 level of significance|t-test, 2 sided|||Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 2 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects.||||0.3226
71080942|NCT02688764|141668471|SUPERIORITY|||||||0.5682||||||0.05 level of significance|t-test, 2 sided|||"Age group of \>=2 years to \<6 years~Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects."||||0.5682
71120054|NCT02868034|141745845|SUPERIORITY||interaction relative mean difference|-0.44||||0.025|TWO_SIDED|97.5|-4.63|3.75|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 4 weeks||3.75|-4.63|0.025
71120055|NCT02868034|141745845|SUPERIORITY||interaction relative mean difference|2.01||||0.025|TWO_SIDED|97.5|-2.77|6.8|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 12 weeks||6.80|-2.77|0.025
71120056|NCT02868034|141745845|SUPERIORITY||3-way interaction relative mean dif.|-0.18||||0.025|TWO_SIDED|97.5|-4.37|4.01|||Mixed Models Analysis|||Three-way interaction effect of SMT, activating exercise and mobilizing exercise components after 4 weeks||4.01|-4.37|0.025
71120057|NCT02868034|141745845|SUPERIORITY||3-way interaction relative mean dif.|0.56||||0.025|TWO_SIDED|97.5|-4.22|5.35|||Mixed Models Analysis|||Three-way interaction effect of SMT, activating exercise and mobilizing exercise components after 12 weeks||5.35|-4.22|0.025
71120058|NCT02868034|141745846|SUPERIORITY||Mean Difference (Final Values)|-1.16||||0.025|TWO_SIDED|97.5|-4.0|1.68|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater improvement in disability when the component was used|SMT Treatment Component Main Effect at 4-weeks||1.68|-4.0|0.025
71120059|NCT02868034|141745846|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.025|TWO_SIDED|97.5|-3.46|3.07|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater improvement in disability when the component was used|SMT Treatment Component Main Effect at 12-weeks||3.07|-3.46|0.025
71120060|NCT02868034|141745846|SUPERIORITY||Mean Difference (Final Values)|-1.36||||0.025|TWO_SIDED|97.5|-4.2|1.48|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater improvement in disability when the component was used|Mobilizing Exercise Treatment Component main effect after 4-weeks||1.48|-4.2|0.025
71120061|NCT02868034|141745846|SUPERIORITY||Mean Difference (Final Values)|-1.72||||0.025|TWO_SIDED|97.5|-4.99|1.55|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater improvement in disability when the component was used|Mobilizing Exercise Treatment Component main effect after 12-weeks||1.55|-4.99|0.025
70854998|NCT02880956|141198370|SUPERIORITY||Effect size/pooled SD|-0.17|STANDARD_DEVIATION|0.76|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71080943|NCT02688764|141668471|SUPERIORITY|||||||0.2271||||||0.05 level of significance|t-test, 2 sided|||"Age group of \>=6 years to \<12 years~Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects."||||0.2271
71080944|NCT02688764|141668471|SUPERIORITY|||||||0.022||||||0.05 level of significance|t-test, 2 sided|||"Age group of \>=12 years to \<=18 years~Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects."||||0.0220
71080945|NCT02688764|141668472|SUPERIORITY|||||||0.0058||||||0.05 level of significance|t-test, 2 sided|||"Group of SP at baseline above Age Related Normal Range~Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects."||||0.0058
71120062|NCT02868034|141745846|SUPERIORITY||Mean Difference (Final Values)|-2.34||||0.025|TWO_SIDED|97.5|-5.18|0.5|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater improvement in disability when the component was used|Activating Exercise Treatment Component main effect after 4-weeks||0.50|-5.18|0.025
71080946|NCT02688764|141668472|SUPERIORITY|||||||0.5801||||||0.05 level of significance|t-test, 2 sided|||"Group of SP at baseline below or within Age Related Normal Range~Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects."||||0.5801
71080947|NCT00885378|141668476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.51|STANDARD_ERROR_OF_MEAN|6.162||0.1248|TWO_SIDED|95.0|-21.68|2.66|||ANCOVA|ANCOVA model: post - pre = pretreatment.|Estimate = adjusted mean change for Saxagliptin - adjusted mean change for Placebo.|||2.66|-21.68|0.1248
71080948|NCT00885378|141668477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.2|||||TWO_SIDED|95.0|1.1|25.4|||||Adjusted for baseline.|||25.4|1.1|
71080949|NCT00885378|141668478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.8|||||TWO_SIDED|95.0|3.0|24.7|||||Adjusted for baseline.|||24.7|3.0|
71080950|NCT00885378|141668485|SUPERIORITY_OR_OTHER||Standard Error of the Mean|-0.34||||0.0063|TWO_SIDED|95.0|-0.58|-0.1||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo at Week 12(LOCF) was adjusted for baseline.|difference between week t value - baseline value = baseline value + treatment.|||-0.10|-0.58|0.0063
71080951|NCT05725824|141668515|SUPERIORITY||||||<|0.05|||||||Repeated Measure Analysis of Variance|||||||<0.05
71080952|NCT05725824|141668516|SUPERIORITY||||||<|0.05|||||||Repeated Measure Analysis of Variance|||||||<0.05
71080953|NCT05725824|141668517|SUPERIORITY||||||<|0.05||||||Arms/Groups were collapsed for RM-ANOVA to compare between various earmold types. A post-hoc paired t-test w/ Bonferroni correction was utilized to compare ear mold material types.|Repeated Measure Analysis of Variance|||||||<0.05
71120063|NCT02868034|141745846|SUPERIORITY||Mean Difference (Final Values)|-3.62||||0.025|TWO_SIDED|97.5|-6.89|-0.35|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater improvement in disability when the component was used|Activating Treatment Component Main Effect after 12-weeks||-0.35|-6.89|0.025
71120064|NCT02868034|141745846|SUPERIORITY||interaction relative mean difference|3.24||||0.025|TWO_SIDED|97.5|-2.45|8.92|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 4 weeks||8.92|-2.45|0.025
71120065|NCT02868034|141745846|SUPERIORITY||interaction relative mean difference|4.34||||0.025|TWO_SIDED|97.5|-2.19|10.87|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 12 weeks||10.87|-2.19|0.025
71120066|NCT02868034|141745846|SUPERIORITY||interaction relative mean difference|0.57||||0.025|TWO_SIDED|97.5|-5.12|6.25|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 4 weeks||6.25|-5.12|0.025
71120067|NCT02868034|141745846|SUPERIORITY||interaction relative mean difference|-0.67||||0.025|TWO_SIDED|97.5|-7.2|5.87|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 12 weeks||5.87|-7.20|0.025
71120068|NCT02868034|141745846|SUPERIORITY||interaction relative mean difference|4.64||||0.025|TWO_SIDED|97.5|-1.04|10.32|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 4 weeks||10.32|-1.04|0.025
71120069|NCT02868034|141745846|SUPERIORITY||interaction relative mean difference|1.49||||0.025|TWO_SIDED|97.5|-5.04|8.02|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 12 weeks||8.02|-5.04|0.025
71120070|NCT02868034|141745846|SUPERIORITY||3-way interaction relative mean dif.|-0.86||||0.025|TWO_SIDED|97.5|-6.54|4.82|||Mixed Models Analysis|||3-way interaction effect of SMT, activating exercise and mobilizing exercise components after 4 weeks||4.82|-6.54|0.025
71120071|NCT02868034|141745846|SUPERIORITY||3-way interaction relative mean dif.|0.04||||0.025|TWO_SIDED|97.5|-6.5|6.57|||Mixed Models Analysis|||3-way interaction effect of SMT, activating exercise and mobilizing exercise components after 12 weeks||6.57|-6.50|0.025
71080954|NCT05725824|141668518|SUPERIORITY||||||<|0.05|||||||Repeated Measure Analysis of Variance|||||||<0.05
71080955|NCT03252145|141668524|OTHER|||||||0.096|||||||t-test, 2 sided|||||||0.096
71080956|NCT03252145|141668525|OTHER|||||||0.206|||||||t-test, 2 sided|||||||0.206
71080957|NCT03252145|141668526|OTHER|||||||0.096|||||||t-test, 2 sided|||||||0.096
71120072|NCT02868034|141745847|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.025|TWO_SIDED|97.5|-0.6|0.32|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in pain intensity when the component was used|SMT Treatment Component Main Effect at 4-weeks||0.32|-0.60|0.025
71120073|NCT02868034|141745847|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.025|TWO_SIDED|97.5|-0.44|0.61|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in pain intensity when the component was used|SMT Treatment Component Main Effects at 12 weeks||0.61|-0.44|0.025
71120074|NCT02868034|141745847|SUPERIORITY||Mean Difference (Final Values)|-0.46||||0.025|TWO_SIDED|97.5|-0.92|0.0|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in pain intensity when the component was used|Mobilizing Exercise Component Main Effects at 4 weeks||0.0|-0.92|0.025
71120075|NCT02868034|141745847|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.025|TWO_SIDED|97.5|-0.7|0.34|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in pain intensity when the component was used|Mobilizing Exercise Component Main Effects at 12 weeks||0.34|-0.70|0.025
71120076|NCT02868034|141745847|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.025|TWO_SIDED|97.5|-0.62|0.3|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in pain intensity when the component was used|Activating Exercise Component Main Effects at 4 weeks||0.30|-0.62|0.025
70854999|NCT02880956|141198370|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.099||0.799|TWO_SIDED|95.0|-0.219|0.169||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.169|-0.219|0.799
70855000|NCT02880956|141198370|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|0.7|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855001|NCT02880956|141198370|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.098||0.406|TWO_SIDED|95.0|-0.273|0.111||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.111|-0.273|0.406
70855002|NCT02880956|141198370|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|0.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70954243|NCT00688870|141411076|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|3.05|||||TWO_SIDED|95.0|2.28|4.08|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 6A||4.08|2.28|
71080958|NCT03252145|141668527|OTHER|||||||0.206|||||||t-test, 2 sided|||||||0.206
71080959|NCT03252145|141668528|OTHER|||||||0.552|||||||t-test, 2 sided|||||||0.552
71080960|NCT03252145|141668529|OTHER|||||||0.498|||||||t-test, 2 sided|||||||0.498
71120077|NCT02868034|141745847|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.025|TWO_SIDED|97.5|-0.71|0.33|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in pain intensity when the component was used|Activating Exercise Component Main Effects at 12 weeks||0.33|-0.71|0.025
71120078|NCT02868034|141745847|SUPERIORITY||interaction relative mean difference|0.38||||0.025|TWO_SIDED|97.5|-0.54|1.3|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 4 weeks||1.30|-0.54|0.025
71120079|NCT02868034|141745847|SUPERIORITY||interaction relative mean difference|0.45||||0.025|TWO_SIDED|97.5|-0.6|1.49|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 12 weeks||1.49|-0.60|0.025
71120080|NCT02868034|141745847|SUPERIORITY||interaction relative mean difference|0.12||||0.025|TWO_SIDED|97.5|-0.8|1.04|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 4 weeks||1.04|-0.80|0.025
71120081|NCT02868034|141745847|SUPERIORITY||interaction relative mean difference|0.23||||0.025|TWO_SIDED|97.5|-0.81|1.28|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 12 weeks||1.28|-0.81|0.025
71080961|NCT03252145|141668530|OTHER|||||||0.264|||||||t-test, 2 sided|||Affected Arm Only||||0.264
71120082|NCT02868034|141745847|SUPERIORITY||interaction relative mean difference|0.89||||0.025|TWO_SIDED|97.5|-0.03|1.81|||Mixed Models Analysis|||||1.81|-0.03|0.025
71080962|NCT03252145|141668530|OTHER|||||||0.224|||||||t-test, 2 sided|||Unaffected arm||||0.224
71080963|NCT03252145|141668531|OTHER|||||||0.125|||||||t-test, 2 sided|||Affected arm||||0.125
71080964|NCT03252145|141668531|OTHER|||||||0.241|||||||t-test, 2 sided|||Unaffected arm||||0.241
71080965|NCT03252145|141668532|OTHER|||||||0.261|||||||t-test, 2 sided|||Affected Arm||||0.261
71080966|NCT03252145|141668532|OTHER|||||||0.597|||||||t-test, 2 sided|||Unaffected Arm||||0.597
71080967|NCT03252145|141668533|OTHER|||||||0.596|||||||t-test, 2 sided|||Affected arm||||0.596
71080968|NCT03252145|141668533|OTHER|||||||0.219|||||||t-test, 2 sided|||Unaffected arm||||0.219
71080969|NCT03252145|141668534|OTHER|||||||0.842|||||||t-test, 2 sided|||||||0.842
71080970|NCT03252145|141668535|OTHER|||||||0.772|||||||t-test, 2 sided|||||||0.772
71080971|NCT03252145|141668536|OTHER|||||||0.3|||||||t-test, 2 sided|||||||0.300
71080972|NCT03252145|141668537|OTHER|||||||0.3|||||||t-test, 2 sided|||||||0.300
71080973|NCT03252145|141668538|OTHER|||||||0.679|||||||t-test, 2 sided|||||||0.679
71120083|NCT02868034|141745847|SUPERIORITY||interaction relative mean difference|-0.02||||0.025|TWO_SIDED|97.5|-1.07|1.02|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 12 weeks||1.02|-1.07|0.025
71120084|NCT02868034|141745847|SUPERIORITY||3-way interaction relative mean dif.|0.71||||0.025|TWO_SIDED|97.5|-0.21|1.63|||Mixed Models Analysis|||3-way interaction effect of SMT, activating exercise and mobilizing exercise components after 4 weeks||1.63|-0.21|0.025
71120085|NCT02868034|141745847|SUPERIORITY||3-way interaction relative mean dif.|0.0||||0.025|TWO_SIDED|97.5|-1.05|1.04|||Mixed Models Analysis|||3-way interaction effect of SMT, activating exercise and mobilizing exercise components after 12 weeks||1.04|-1.05|0.025
71120086|NCT01509677|141745850|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7922||||||"This is p-value testing significance of treatment effect"|Poisson regression model|||2-sided test at 5% significant level||||0.7922
71120087|NCT01509677|141745850|SUPERIORITY||Risk Ratio (RR)|1.03|STANDARD_ERROR_OF_MEAN|0.12||0.7917|TWO_SIDED|95.0|0.82|1.3|||Poisson regression model|||||1.30|0.82|0.7917
71120088|NCT01509677|141745851|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7145||||||"This is p-value testing significance of treatment effect"|Poisson regression model|||2-sided, 5% test||||0.7145
71120089|NCT01509677|141745852|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.04|STANDARD_ERROR_OF_MEAN|0.119||0.7136|TWO_SIDED|95.0|0.83|1.3|||Poisson regression model|||2-sided 5% test||1.30|0.83|0.7136
71120090|NCT01509677|141745853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.4|STANDARD_ERROR_OF_MEAN|15.45||0.4606||95.0|-19.2|42.1|||ANCOVA|||2-sided 5% test||42.1|-19.2|0.4606
71120091|NCT01509677|141745854|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.19|STANDARD_ERROR_OF_MEAN|0.194||0.2744|TWO_SIDED|95.0|0.87|1.64|||Poisson regression model|||2-sided 5% test||1.64|0.87|0.2744
71080974|NCT03252145|141668539|OTHER|||||||0.12|||||||t-test, 2 sided|||||||0.120
71080975|NCT03252145|141668540|OTHER|||||||0.138|||||||t-test, 2 sided|||||||0.138
71080976|NCT03252145|141668541|OTHER|||||||0.096|||||||t-test, 2 sided|||||||0.096
71080977|NCT03252145|141668542|OTHER|||||||0.206|||||||t-test, 2 sided|||||||0.206
71080978|NCT03252145|141668544|OTHER|||||||0.08|||||||t-test, 2 sided|||||||0.080
71120092|NCT01509677|141745855|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.85|STANDARD_ERROR_OF_MEAN|0.086||0.1128|TWO_SIDED|95.0|0.7|1.04|||Poisson regression model|||2-sided 5% test||1.04|0.70|0.1128
71080979|NCT03252145|141668545|OTHER|||||||0.068|||||||t-test, 2 sided|||Physical Function Domain||||0.068
71080980|NCT03252145|141668545|OTHER|||||||0.808|||||||t-test, 2 sided|||Anxiety Domain||||0.808
71080981|NCT03252145|141668545|OTHER|||||||0.557|||||||t-test, 2 sided|||Depression Domain||||0.557
71080982|NCT03252145|141668545|OTHER|||||||0.049|||||||t-test, 2 sided|||Fatigue Domain||||0.049
71080983|NCT03252145|141668545|OTHER|||||||0.279|||||||t-test, 2 sided|||Sleep Disturbance Domain||||0.279
71080984|NCT03252145|141668545|OTHER|||||||0.02|||||||t-test, 2 sided|||Roles/Activity Domain||||0.020
71080985|NCT03252145|141668545|OTHER|||||||0.009|||||||t-test, 2 sided|||Pain Interference Domain||||0.009
71080986|NCT03252145|141668546|OTHER|||||||0.038|||||||t-test, 2 sided|||Physical Function Domain||||0.038
71080987|NCT03252145|141668546|OTHER|||||||0.108|||||||t-test, 2 sided|||Anxiety Domain||||0.108
71080988|NCT03252145|141668546|OTHER|||||||0.467|||||||t-test, 2 sided|||Depression Domain||||0.467
71080989|NCT03252145|141668546|OTHER|||||||0.078|||||||t-test, 2 sided|||Fatigue Domain||||0.078
71080990|NCT03252145|141668546|OTHER|||||||0.147|||||||t-test, 2 sided|||Sleep Disturbance Domain||||0.147
71080991|NCT03252145|141668546|OTHER|||||||0.004|||||||t-test, 2 sided|||Roles/Activity Domain||||0.004
71080992|NCT03252145|141668546|OTHER|||||||0.032|||||||t-test, 2 sided|||Pain Interference Domain||||0.032
71080993|NCT03252145|141668547|OTHER|||||||0.938|||||||t-test, 2 sided|||||||0.938
71080994|NCT03252145|141668548|OTHER|||||||0.603|||||||t-test, 2 sided|||||||0.603
71080995|NCT03252145|141668549|OTHER|||||||0.837|||||||t-test, 2 sided|||||||0.837
71080996|NCT03252145|141668550|OTHER|||||||0.511|||||||t-test, 2 sided|||||||0.511
71080997|NCT03252145|141668551|OTHER|||||||0.326|||||||t-test, 2 sided|||||||0.326
71080998|NCT01267929|141668560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|2.14||0.34|TWO_SIDED|95.0|-2.3|6.5||Statistical analysis was conducted using STATA. Analysis of Covariance (ANCOVA) was used to compare mean score of GMFM at the second month between two groups.|ANCOVA|||A sample size of 30 children, 15 for each group, was needed to obtain 80% power at 0.05 level of significance (two-sided) to test that the successful event rate (increasing GMFM scores at least 30% from baseline at the end of 2 months) in experimental group and control group of 0.3 and 0.8 respectively. The mean changes of GMFM total scores in the experimental group at the second month compared to those in the control group after adjusted for the baseline level.||6.5|-2.3|0.34
71080999|NCT01267929|141668560|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|2.7||0.78|TWO_SIDED|95.0|-6.3|4.7||Statistical analysis was conducted using STATA. Analysis of Covariance (ANCOVA) was used to compare mean score of GMFM at the sixth month between two groups.|ANCOVA|||A sample size of 30 children, 15 for each group, was needed to obtain 80% power at 0.05 level of significance (two-sided) to test that the successful event rate (increasing GMFM scores at least 30% from baseline at the end of 2 months) in experimental group and control group of 0.3 and 0.8 respectively. The mean changes of GMFM total scores in the experimental group at the sixth month compared to those in the control group after adjusted for the baseline level.||4.7|-6.3|0.78
71081000|NCT03746405|141668580|SUPERIORITY||Mean Difference (Final Values)|1.15|||=|0.03|TWO_SIDED|||||Give the limited sample size, this p-value was not adjusted for multiple comparisons. The threshold for statistical significant was p \< 0.05|t-test, 2 sided|||Hypothesis: Active rTMS applied over the node in the medial prefrontal cortex the most strongly negatively connected to the right amygdala will decrease amygdala BOLD activation compared to sham rTMS||||= 0.03
71081001|NCT01703169|141668581|OTHER||||||||||||||||||The proportion of platelet response in a previous study (PMID:22762314) was 0.36 (9/25). The null hypothesis of no difference between the platelet response rate in this study and that of the previous study was tested using a two-sided exact test of binomial proportions. A p-value of 0.40 was obtained. The threshold for significance was 0.05.|||
71081002|NCT00947310|141668624|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45||||0.01|TWO_SIDED|95.0|0.24|0.85|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm B. Null Hypothesis was that HR = 1||0.85|0.24|0.01
71081003|NCT00947310|141668624|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.56||||0.06|TWO_SIDED|95.0|0.3|1.02|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm C. Null Hypothesis was that HR = 1||1.02|0.30|0.06
71081004|NCT00947310|141668625|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.39|TWO_SIDED|95.0|0.71|2.47|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm B. Null Hypothesis was that HR = 1||2.47|0.71|0.39
71081005|NCT00947310|141668625|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.8|TWO_SIDED|95.0|0.58|2.05|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm C. Null Hypothesis was that HR = 1||2.05|0.58|0.80
71081006|NCT00947310|141668626|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.21|||<|0.001|TWO_SIDED|95.0|0.13|0.34|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm B. Null Hypothesis was that HR = 1||0.34|0.13|<0.001
71081007|NCT00947310|141668626|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.24|||<|0.001|TWO_SIDED|95.0|0.15|0.4|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm C. Null Hypothesis was that HR = 1||0.40|0.15|<0.001
71081008|NCT05076604|141668637|SUPERIORITY|||||||0.354|||||||t-test, 2 sided|||Intraoperative packed red blood cell transfusion||||0.354
71081009|NCT05076604|141668637|SUPERIORITY|||||||0.314|||||||t-test, 2 sided|||Postoperative red blood cell transfusion||||0.314
71081010|NCT03258645|141668639|OTHER||||||<|0.001|||||||Regression, Linear|||Univariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of National Institute of Health Stroke Scale (NIHSS) score at index date was applied.||||< 0.001
71120093|NCT01509677|141745856|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.93|STANDARD_ERROR_OF_MEAN|0.164||0.674|TWO_SIDED|95.0|0.66|1.31|||Regression, Linear|Poisson regression model||2-sided 5% test||1.31|0.66|0.6740
71120094|NCT01509677|141745857|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.84|STANDARD_ERROR_OF_MEAN|0.082||0.0677|TWO_SIDED|95.0|0.69|1.01|||Poisson regression model|||2-sided 5% test||1.01|0.69|0.0677
71120095|NCT01509677|141745858|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.82|STANDARD_ERROR_OF_MEAN|0.177||0.3566|TWO_SIDED|95.0|0.54|1.25|||Poisson regression model|||2-sided 5% test||1.25|0.54|0.3566
71120096|NCT01509677|141745859|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6354|STANDARD_ERROR_OF_MEAN|2.30185||0.4794|TWO_SIDED|95.0|-2.9429|6.2137|||ANCOVA|||2 sided 5% test||6.2137|-2.9429|0.4794
71120097|NCT01509677|141745860|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4727|STANDARD_ERROR_OF_MEAN|0.32866||0.1541|TWO_SIDED|95.0|-0.181|1.1264|||ANCOVA|||2 sided 5% test||1.1264|-0.1810|0.1541
71081011|NCT03258645|141668640|OTHER|||||||0.01|||||||Regression, Linear|||Univariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of Modified Rankin Scale (mRS) at index date was applied.||||0.01
71120098|NCT01509677|141745861|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.0626|STANDARD_ERROR_OF_MEAN|0.03681||0.0927|TWO_SIDED|95.0|-0.1358|0.0106|||ANCOVA|||2 sided 5% test||0.0106|-0.1358|0.0927
71120099|NCT01509677|141745862|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.0107|STANDARD_ERROR_OF_MEAN|0.01647||0.5175|TWO_SIDED|95.0|-0.0435|0.022|||ANCOVA|||2 sided 5% test||0.0220|-0.0435|0.5175
71081012|NCT03258645|141668641|OTHER|CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol Score.|Odds Ratio (OR)|1.13||||0.016|TWO_SIDED|95.0|1.02|1.25|||Regression, Linear|Relation between age and dabigatran initiation time was reported.||Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.||1.25|1.02|0.016
71081013|NCT03258645|141668642|OTHER|CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol Score.|Odds Ratio (OR)|1.12||||0.002|TWO_SIDED|95.0|1.04|1.21|||Regression, Linear|Relation between Diastolic blood pressure (DBP) and dabigatran initiation time was reported.||Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.||1.21|1.04|0.002
71081014|NCT03258645|141668643|OTHER|CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol Score.|Odds Ratio (OR)|1.1||||0.04|TWO_SIDED|95.0|1.0|1.21|||Regression, Linear|Relation between CHA2DS2-VASc and dabigatran initiation time was reported.||Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.||1.21|1.00|0.04
71081015|NCT03258645|141668644|OTHER|CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol Score.|Odds Ratio (OR)|0.9||||0.051|TWO_SIDED|95.0|0.45|1.0|||Regression, Linear|Relation between HAS-BLED and dabigatran initiation time was reported.||Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.||1.00|0.45|0.051
71081016|NCT03258645|141668645|OTHER|CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol Score.|Odds Ratio (OR)|0.91||||0.026|TWO_SIDED|95.0|0.9|0.93|||Regression, Linear|Relation between History/Predisposition To Bleeding and dabigatran initiation time was reported.||Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.||0.93|0.9|0.026
71081017|NCT01704755|141668650|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 12-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 43% to achieve noninferiority.|Percentage of Participants|91.8|||||TWO_SIDED|97.5|87.6|96.1||||||The study planned to enroll 380 subjects to a 12- or 24-week treatment arm. The primary efficacy endpoint (SVR12) was assessed for each arm. With a total sample size of 380 and assuming that 68% of the subjects in each arm would achieve SVR12, the study had greater than 90% power to demonstrate non-inferiority and superiority with a 2-sided 97.5% lower confidence bound greater than 43% and 54%, respectively, based on the normal approximation of a single binomial proportion.||96.1|87.6|
71120100|NCT01509677|141745863|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.146|STANDARD_ERROR_OF_MEAN|3.3253||0.5205|TWO_SIDED|95.0|-4.466|8.757|||ANCOVA|||2-sided 5 % test||8.757|-4.466|0.5205
71120101|NCT01509677|141745864|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.141|STANDARD_ERROR_OF_MEAN|3.0057||0.7052|TWO_SIDED|95.0|-4.835|7.117|||ANCOVA|||2-sided 5 % test||7.117|-4.835|0.7052
71120102|NCT01509677|141745865|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.867|STANDARD_ERROR_OF_MEAN|0.7331||0.0127|TWO_SIDED|95.0|-3.324|-0.409|||ANCOVA|||2-sided 5 % test||-0.409|-3.324|0.0127
71120103|NCT01509677|141745866|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.051|STANDARD_ERROR_OF_MEAN|0.1871||0.7862|TWO_SIDED|95.0|-0.423|0.321|||ANCOVA|||2-sided 5 % test||0.321|-0.423|0.7862
71120104|NCT01509677|141745867|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|1.005||0.8769|TWO_SIDED|95.0|-1.84|2.15|||ANCOVA|||2-sided 5% test||2.15|-1.84|0.8769
71120105|NCT01509677|141745868|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|711.1|STANDARD_ERROR_OF_MEAN|2768.79||0.7978|TWO_SIDED|95.0|-4778.3|6200.5|||ANCOVA|||2-sided 5% test||6200.5|-4778.3|0.7978
71081018|NCT01704755|141668650|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The superiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 12-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 54% to achieve superiority.|Percentage of Participants|91.8|||||TWO_SIDED|97.5|87.6|96.1||||||The primary efficacy endpoints were the SVR12 rates in each arm. The overall 2-sided significance level of 0.05 was split between the arms using a Bonferroni correction of 0.025. A 2-sided 97.5% CI of the SVR12 rate per arm was computed using the normal approximation to the binomial distribution. A gatekeeping testing procedure was used to control the Type I error rate at 0.05, and the primary endpoints for Arm A were tested separately from Arm B in a pre-specified order.||96.1|87.6|
71081019|NCT01704755|141668650|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 24-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 43% to achieve noninferiority.|Percentage of Participants|96.5|||||TWO_SIDED|97.5|93.4|99.7||||||||99.7|93.4|
71081020|NCT01704755|141668650|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The superiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 24-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 54% to achieve superiority.|Percentage of Participants|96.5|||||TWO_SIDED|97.5|93.4|99.7||||||||99.7|93.4|
71081021|NCT01704755|141668651|SUPERIORITY_OR_OTHER_LEGACY|||||||0.051|TWO_SIDED||||||Regression, Logistic|||To test the hypothesis that the percentages of participants who achieved sustained virologic response 12 weeks after treatment was different between the two treatment groups, the percentages were compared using a logistic regression model with treatment group, baseline log(subscript)10(subscript) HCV RNA level, HCV subgenotype (1a, non-1a), IL28B genotype (CC, non CC), and peginterferon-ribavirin treatment history (treatment-naïve or treatment-experienced) as predictors.||||0.051
71081022|NCT01639703|141668707|OTHER||Odds Ratio (OR)|0.76||||0.2476|TWO_SIDED|95.0|0.47|1.21|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \>50%) considering an increase of 5 units for Blood Volume|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.||1.21|0.47|0.2476
71081023|NCT01639703|141668708|OTHER||Odds Ratio (OR)|1.13||||0.5354|TWO_SIDED|95.0|0.77|1.66|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \>50%) considering an increase of 5 units for Blood Volume|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.||1.66|0.77|0.5354
71081024|NCT01639703|141668709|OTHER||Odds Ratio (OR)|0.9||||0.3487|TWO_SIDED|95.0|0.71|1.13|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \>50%) considering an increase of 10 units for Blood Flow|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.||1.13|0.71|0.3487
70954244|NCT00688870|141411076|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|105.0|||||TWO_SIDED|95.0|75.6|145.84|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 7F||145.84|75.60|
71081025|NCT01639703|141668710|OTHER||Odds Ratio (OR)|1.08||||0.4195|TWO_SIDED|95.0|0.9|1.29|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \>50%) considering an increase of 10 units for Blood Flow|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.||1.29|0.90|0.4195
71120106|NCT01509677|141745869|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|88.5|STANDARD_ERROR_OF_MEAN|79.26||0.2669|TWO_SIDED|95.0|-68.6|245.6|||ANCOVA|||2-sided 5% test||245.6|-68.6|0.2669
71081026|NCT01639703|141668711|OTHER||Odds Ratio (OR)|0.9||||0.7127|TWO_SIDED|95.0|0.53|1.54|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \>50%) considering an increase of 10 units for Permeability Surface|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.||1.54|0.53|0.7127
71081027|NCT01639703|141668712|OTHER||Odds Ratio (OR)|1.41||||0.1753|TWO_SIDED|95.0|0.86|2.31|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \>50%) considering an increase of 10 units for Permeability Surface|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.||2.31|0.86|0.1753
71081028|NCT01515696|141668737|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0||||0.61||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.61
71081029|NCT01515696|141668738|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|7.5||||0.05||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
71081030|NCT01515696|141668739|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
71081031|NCT04274075|141668742|OTHER||Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|0.945|1.12|||||The geometric mean ratio was calculated as Treatment B versus Treatment A.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||1.12|0.945|
71120107|NCT01509677|141745870|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-25.9|STANDARD_ERROR_OF_MEAN|67.78||0.7033|TWO_SIDED|95.0|-160.3|108.5|||ANCOVA|||2-sided 5% test||108.5|-160.3|0.7033
71120108|NCT01509677|141745871|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|27.79|STANDARD_ERROR_OF_MEAN|18.039||0.1264|TWO_SIDED|95.0|-7.97|63.55|||ANCOVA|||2-sided 5% test||63.55|-7.97|0.1264
70943747|NCT02487251|141387629|EQUIVALENCE|Phase 1 sought to determine effect sizes. For Phase 2, sample size was set at 125 per arm which, with 20% attrition, enabled detection of small-medium effect sizes, d = 0.40SD for continuous outcomes and 38% relative risk reduction for binary outcomes, power of 80%, α = .05. Phase 1 analyses included paired t-tests \& examination of pre-post effect size change. Phase 2 analyses included mixed modeling. Negative mean change values reflect a decrease in intake; positive values reflect an increase.|Mean Difference (Final Values)|0.15||||0.21|TWO_SIDED|||||p \< .05 reflects the threshold for statistical significance. The calculated p value for change in parent reported fruit is p = .21.|Mixed Models Analysis||The reported estimation parameter is a standardized mean difference between the groups, specifically cohen's d.|We tested pre to post change in parent reported child fruit intake for each of the four study arms/groups.||||.21
70943748|NCT02487251|141387630|EQUIVALENCE|Phase 1 sought to determine effect sizes. For Phase 2, sample size was set at 125 per arm which, with 20% attrition, enabled detection of small-medium effect sizes, d = 0.40SD for continuous outcomes and 38% relative risk reduction for binary outcomes, power of 80%, α = .05. Phase 1 analyses included paired t-tests \& examination of pre-post effect size change. Phase 2 analyses included mixed modeling. Negative mean change values reflect a decrease in intake; positive values reflect an increase.|Mean Difference (Final Values)|0.07||||0.55|TWO_SIDED|||||p \< .05 reflects the threshold for statistical significance. The calculated p value for change in parent reported vegetables is p = .55.|Mixed Models Analysis||The reported estimation parameter is a standardized mean difference between the groups, specifically cohen's d.|We tested change in vegetable intake for each of the four study arms/groups.||||.55
70943749|NCT02487251|141387631|EQUIVALENCE|Phase 1 sought to determine effect sizes. For Phase 2, sample size was set at 125 per arm which, with 20% attrition, would enable detection of small to medium effect sizes of d = 0.40SD for continuous outcomes and 38% relative risk reduction for binary outcomes with a power of 80% and α = .05.|Mean Difference (Final Values)|-0.02||||0.84|TWO_SIDED|||||p \< .05 reflects the threshold for statistical significance. The calculated p value for change in mealtime frequency is p = .84.|Mixed Models Analysis|||We tested change in frequency of family mealtimes for each of the four study arms/groups.||||.84
70943750|NCT01037413|141387645|SUPERIORITY||Mean Difference (Final Values)|-14.7|||<|0.001|TWO_SIDED|95.0|-21.3|-8.1|||t-test, 2 sided|||Comparison within the participant between EXC 001 and placebo.||-8.1|-21.3|<0.001
71081032|NCT04274075|141668742|OTHER||Geometric Mean Ratio|0.79|||||TWO_SIDED|90.0|0.726|0.859|||||The geometric mean ratio was calculated as Treatment C versus Treatment B.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||0.859|0.726|
71081033|NCT04274075|141668743|OTHER||Median Difference (Net)|0.525|||||TWO_SIDED|90.0|-0.225|1.5|||||The Hodges-Lehmann estimate of median difference was calculated as Treatment B versus Treatment A.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||1.50|-0.225|
71081034|NCT04274075|141668743|OTHER||Median Difference (Net)|1.98|||||TWO_SIDED|90.0|1.26|2.45|||||The Hodges-Lehmann estimate of median difference was calculated as Treatment C versus Treatment B.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||2.45|1.26|
71081035|NCT04274075|141668746|OTHER||Geometric Mean Ratio|0.971|||||TWO_SIDED|90.0|0.903|1.04|||||The geometric mean ratio was calculated as Treatment B versus Treatment A.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||1.04|0.903|
71081036|NCT04274075|141668746|OTHER||Geometric Mean Ratio|0.919|||||TWO_SIDED|90.0|0.855|0.988|||||The geometric mean ratio was calculated as Treatment C versus Treatment B.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||0.988|0.855|
70943751|NCT01037413|141387646|SUPERIORITY||Mean Difference (Final Values)|-14.8|||<|0.001|TWO_SIDED|95.0|-21.2|-8.3|||t-test, 2 sided|||Week 8: Comparison within the participant between EXC 001 and placebo.||-8.3|-21.2|<0.001
71081037|NCT04274075|141668747|OTHER||Geometric Mean Ratio|0.975|||||TWO_SIDED|90.0|0.908|1.05|||||The geometric mean ratio was calculated as Treatment B versus Treatment A.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||1.05|0.908|
71081038|NCT04274075|141668747|OTHER||Geometric Mean Ratio|0.918|||||TWO_SIDED|90.0|0.856|0.985|||||The geometric mean ratio was calculated as Treatment C versus Treatment B.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||0.985|0.856|
71081039|NCT00423813|141668823|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||Overall Comparison||||0.001
71081040|NCT00423813|141668823|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||Pairwise comparison of Xyrem 4.5g and placebo||||<0.001
71081041|NCT00423813|141668823|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||Pairwise comparison of Xyrem 6.0g and placebo||||0.001
71081042|NCT01386944|141668824|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-0.5|||||TWO_SIDED|95.0|-1.0|-0.5||||||||-0.5|-1.0|
71081043|NCT01386944|141668825|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-1.5|||||TWO_SIDED|95.0|-1.5|-1.0||||||||-1.0|-1.5|
71081044|NCT01386944|141668826|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-2.0||||||95.0|-2.0|-1.5||||||||-1.5|-2.0|
71081045|NCT01386944|141668827|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-2.0||||||95.0|-2.5|-1.5||||||||-1.5|-2.5|
71081046|NCT01386944|141668828|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-2.0||||||95.0|-2.5|-1.5||||||||-1.5|-2.5|
71081047|NCT01386944|141668829|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-2.0||||||95.0|-2.0|-1.5||||||||-1.5|-2.0|
71081048|NCT03883477|141668831|OTHER|The trial was powered to detect a difference in POSAS score of 10, deemed to be clinically significant by the investigators. To detect a mean difference in POSAS score of 10 points (SD = 8) with a two-sided significance level of 5% and power of 80% with equal allocation to two arms required 12 patients in each arm of the trial.||||||0.013||||||1 week P-value|Wilcoxon (Mann-Whitney)|||||||0.013
70855003|NCT02880956|141198370|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.099||0.363|TWO_SIDED|95.0|-0.285|0.105||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.105|-0.285|0.363
70943752|NCT01037413|141387646|SUPERIORITY||Mean Difference (Final Values)|-26.0|||<|0.001|TWO_SIDED|95.0|-34.3|-17.7|||t-test, 2 sided|||Week 24: Comparison within the participant between EXC 001 and placebo.||-17.7|-34.3|<0.001
70943753|NCT01037413|141387647|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.033|TWO_SIDED|95.0|-2.3|-0.1|||t-test, 2 sided|||Week 12, Vascularity: Comparison within the participant between EXC 001 and placebo.||-0.1|-2.3|0.033
71081049|NCT03883477|141668831|OTHER|||||||0.007||||||1 month P-value|Wilcoxon (Mann-Whitney)|||The trial was powered to detect a difference in POSAS score of 10, deemed to be clinically significant by the investigators. To detect a mean difference in POSAS score of 10 points (SD = 8) with a two-sided significance level of 5% and power of 80% with equal allocation to two arms required 12 patients in each arm of the trial.||||0.007
71081050|NCT03883477|141668831|OTHER|||||||0.804||||||6 month P-value|Wilcoxon (Mann-Whitney)|||The trial was powered to detect a difference in POSAS score of 10, deemed to be clinically significant by the investigators. To detect a mean difference in POSAS score of 10 points (SD = 8) with a two-sided significance level of 5% and power of 80% with equal allocation to two arms required 12 patients in each arm of the trial.||||0.804
71081051|NCT03883477|141668832|OTHER|||||||0.142|||||||Wilcoxon (Mann-Whitney)|||||||0.142
71081052|NCT03883477|141668833|OTHER|||||||0.561|||||||Wilcoxon (Mann-Whitney)|||||||0.561
71081053|NCT03883477|141668834|OTHER|||||||0.748|||||||Wilcoxon (Mann-Whitney)|||||||0.748
71081054|NCT03883477|141668835|OTHER|||||||0.184|||||||Wilcoxon (Mann-Whitney)|||||||0.184
71081055|NCT03883477|141668836|OTHER|||||||0.382|||||||Chi-squared|||||||0.382
71081056|NCT03883477|141668837|OTHER|||||||0.382|||||||Chi-squared|||||||0.382
71081057|NCT03658642|141668844|SUPERIORITY||Odds Ratio (OR)|1.22||||0.58|TWO_SIDED|95.0|0.61|2.43|||GEE|Obtained from a GEE model accounting for clustering by site and multiple covariates.||||2.43|0.61|0.58
71081058|NCT03658642|141668845|SUPERIORITY||Odds Ratio (OR)|1.03||||0.95|TWO_SIDED|95.0|0.43|2.47|||GEE|Obtained from a GEE model accounting for clustering by site.||||2.47|0.43|0.95
71120109|NCT01509677|141745872|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|296.8|STANDARD_ERROR_OF_MEAN|124.07||0.0185|TWO_SIDED|95.0|50.9|542.7|||ANCOVA|||2-sided 5% test||542.7|50.9|0.0185
71120110|NCT01509677|141745873|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.086||0.9989|TWO_SIDED|95.0|-0.17|0.17|||ANCOVA|||2-sided 5% test||0.17|-0.17|0.9989
71120111|NCT01509677|141745874|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|1.309||0.6701|TWO_SIDED|95.0|-3.15|2.03|||ANCOVA|||2-sided 5% test||2.03|-3.15|0.6701
71120112|NCT01509677|141745875|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|1.1||0.1105|TWO_SIDED|95.0|-0.4|3.9|||ANCOVA|||2-sided 5% test||3.9|-0.4|0.1105
71120113|NCT01509677|141745876|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|15.62||0.9261|TWO_SIDED|95.0|-32.4|29.5|||ANCOVA|||2-sided 5% test||29.5|-32.4|0.9261
71120114|NCT01509677|141745877|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.1|STANDARD_ERROR_OF_MEAN|4.49||0.0257|TWO_SIDED|95.0|1.2|19.0|||ANCOVA|||2-sided 5% test||19.0|1.2|0.0257
71120115|NCT01509677|141745878|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|32.8|STANDARD_ERROR_OF_MEAN|18.11||0.0728|TWO_SIDED|95.0|-3.0|168.6|||ANCOVA|||2-sided 5% test||168.6|-3.0|0.0728
71081059|NCT03658642|141668847|SUPERIORITY||Odds Ratio (OR)|1.55||||0.01|TWO_SIDED|95.0|1.11|2.16|||GEE|Obtained from a GEE model accounting for clustering by site.||||2.16|1.11|0.01
71081060|NCT03658642|141668848|SUPERIORITY||Odds Ratio (OR)|1.13||||0.48|TWO_SIDED|95.0|0.91|1.57|||GEE|Obtained from a GEE model accounting for clustering by site.||||1.57|0.91|0.48
71081061|NCT03658642|141668849|SUPERIORITY||Odds Ratio (OR)|1.32||||0.27|TWO_SIDED|95.0|0.81|2.14|||GEE|Obtained from a GEE model accounting for clustering by site.||||2.14|0.81|0.27
71081062|NCT02137226|141668872|NON_INFERIORITY_OR_EQUIVALENCE|The 90% Confidence Interval (CI) for ACR20 at Week 12, rounded to 1 decimal place, had to be entirely contained in the predefined equivalence region \[-12.0%, 15.0%\]|Difference in proportions|5.9|||||TWO_SIDED|90.0|-0.9|12.7|||Regression, Logistic||Results from logistic regression model adjusted for treatment, prior exposure to a biologic agent (yes / no), Baseline DAS28 (ESR). Difference in ACR20 Response Rate (BI695501 - Humira, %) is presented.|The week 12 confidence interval for the estimated difference in proportion is produced using the cumulative distribution function method of Reeve||12.7|-0.9|
71081063|NCT02137226|141668873|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin is not applicable|Mean Difference (Final Values)|-0.1|||||TWO_SIDED|90.0|-0.25|0.05|||ANCOVA||Difference in least square means of BI 695501 - Humira is presented.|Results based on DAS28 (ESR) mean changes from Baseline after 12 weeks of treatment = overall mean + treatment group + Baseline DAS28 (ESR) + prior exposure to a biologic agent + random error.||0.05|-0.25|
71081064|NCT02137226|141668873|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin is not applicable|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.17|0.23|||ANCOVA||Difference in least square means of BI 695501 - Humira is presented.|Results based on DAS28 (ESR) mean changes from Baseline after 24 weeks of treatment = overall mean + treatment group + Baseline DAS28 (ESR) + prior exposure to a biologic agent + random error.||0.23|-0.17|
71081065|NCT02137226|141668875|NON_INFERIORITY_OR_EQUIVALENCE|The 95% Confidence Interval (CI) for ACR20 at Week 24, rounded to 1 decimal place, had to be entirely contained in the predefined equivalence region \[-15.0%;+15.0%\]|Difference in proportions|4.5|||||TWO_SIDED|95.0|-3.4|12.5|||Regression, Logistic||Results from logistic regression model adjusted for treatment, prior exposure to a biologic agent (yes / no), Baseline DAS28 (ESR). Difference in ACR20 Response Rate (BI695501 - Humira, %) is presented.|The week 24 confidence interval for the estimated difference in proportion is produced using the cumulative distribution function method of Reeve||12.5|-3.4|
71120116|NCT01509677|141745879|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.03||0.038|TWO_SIDED|95.0|0.004|0.122|||ANCOVA|||2-sided 5% test||0.122|0.004|0.0380
71120117|NCT01509677|141745880|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.064|STANDARD_ERROR_OF_MEAN|0.0552||0.2482|TWO_SIDED|95.0|-0.045|0.173|||ANCOVA|||2-sided 5% test||0.173|-0.045|0.2482
71120118|NCT01509677|141745881|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-1.0||||0.2629|TWO_SIDED|95.0|-2.0|1.0|||Wilcoxon (Mann-Whitney)|Between treatment difference||2 sided 5 % test||1.00|-2.00|0.2629
71120119|NCT02124512|141745882|SUPERIORITY||||||>|0.05||||||The p-value was calculated to be \>0.05.|ANOVA|||Comparison of the pre- and post-treatment timecourse between untreated and rifaximin-treated participants.||||>0.05
71120120|NCT02124512|141745883|SUPERIORITY|||||||0.12||||||unpaired Student's t-test|t-test, 2 sided|||Treatment difference (change in placebo pre- and post-treatment versus change in rifaximin pre- and post-treatment).||||0.12
70855004|NCT02880956|141198370|SUPERIORITY||Effect size/pooled SD|0.12|STANDARD_DEVIATION|0.76|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71120121|NCT01779869|141745933|SUPERIORITY|Accuracy was assessed compared to an imaging reference standard.||||||0.35|||||||Chi-squared|||Significance testing between the diagnostic accuracy of SPECT and PET, and SPECT and MR, and SPECT and PET/MR was performed by using chi square test. A P value \< 0.05 was considered significant.||||0.35
71120122|NCT01459653|141745939|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.884||||0.3038|TWO_SIDED|95.0|0.6989|1.1182|||Chi-squared|||||1.1182|0.6989|0.3038
71120123|NCT01459653|141745940|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1897||||0.1432|TWO_SIDED|95.0|0.9428|1.5012|||Chi-squared|||||1.5012|0.9428|0.1432
71120124|NCT01459653|141745941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8794||||0.6483|TWO_SIDED|95.0|0.5063|1.5276|||Chi-squared|||||1.5276|0.5063|0.6483
71120125|NCT01459653|141745951|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2989|||<|0.0001|TWO_SIDED|95.0|1.8113|2.9177|||Chi-squared|||||2.9177|1.8113|<0.0001
71120126|NCT01459653|141745952|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4963|||<|0.0001|TWO_SIDED|95.0|0.373|0.6605|||Chi-squared|||||0.6605|0.3730|<0.0001
71120127|NCT01459653|141745953|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9451||||0.7509|TWO_SIDED|95.0|0.6671|1.3391|||Chi-squared|||||1.3391|0.6671|0.7509
71120128|NCT01459653|141745954|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2683||||0.0067|TWO_SIDED|95.0|1.068|1.5061|||Chi-squared|||||1.5061|1.0680|0.0067
71120129|NCT01459653|141745962|SUPERIORITY_OR_OTHER||Slope|1.0628|||<|0.0001|TWO_SIDED|95.0|0.6382|1.4874|||ANOVA|degrees of freedom: 4507||||1.4874|0.6382|<0.0001
71120130|NCT01459653|141745963|SUPERIORITY_OR_OTHER||Slope|-0.2739||||0.0103|TWO_SIDED|95.0|-0.4832|-0.0646|||ANOVA|degrees of freedom: 4507||||-0.0646|-0.4832|0.0103
71120131|NCT01459653|141745964|SUPERIORITY_OR_OTHER||Slope|0.3812|||<|0.0001|TWO_SIDED|95.0|0.233|0.5295|||ANOVA|degrees of freedom: 4495||||0.5295|0.2330|<0.0001
71120132|NCT01459653|141745972|SUPERIORITY_OR_OTHER||Slope|0.1031||||0.0677|TWO_SIDED|95.0|-0.0075|0.2136|||ANOVA|degrees of freedom: 4516||||0.2136|-0.0075|0.0677
71120133|NCT01459653|141745973|SUPERIORITY_OR_OTHER||Slope|0.0018||||0.8968|TWO_SIDED|95.0|-0.0259|0.0295|||ANOVA|degrees of freedom: 4516||||0.0295|-0.0259|0.8968
71120134|NCT01459653|141745974|SUPERIORITY_OR_OTHER||Slope|0.0741|||<|0.0001|TWO_SIDED|95.0|-0.0452|0.1029|||ANOVA|degrees of freedom: 4505||||0.1029|-0.0452|<0.0001
71120135|NCT01459653|141745982|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.735||||0.2698|TWO_SIDED|95.0|0.4255|1.2698|||Chi-squared|||||1.2698|0.4255|0.2698
71120136|NCT01459653|141745983|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Chi-squared|||||||<0.0001
71120137|NCT01459653|141746000|SUPERIORITY_OR_OTHER|||||||0.5977|TWO_SIDED||||||Log Rank|||||||0.5977
71120138|NCT01459653|141746001|SUPERIORITY_OR_OTHER|||||||0.2435|TWO_SIDED||||||Log Rank|||||||0.2435
71120139|NCT01459653|141746002|SUPERIORITY_OR_OTHER|||||||0.763|TWO_SIDED||||||Log Rank|||||||0.7630
71120140|NCT01459653|141746003|SUPERIORITY_OR_OTHER|||||||0.383|TWO_SIDED||||||Log Rank|||||||0.3830
71120141|NCT01459653|141746004|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Log Rank|||||||0.0002
71120142|NCT01459653|141746005|SUPERIORITY_OR_OTHER|||||||0.0301|TWO_SIDED||||||Log Rank|||||||0.0301
71120143|NCT01459653|141746006|SUPERIORITY_OR_OTHER||Slope|0.92||||0.0683|TWO_SIDED|95.0|0.84|1.01|||Regression, Logistic|degrees of freedom: 3181||GCSF treatment decision (under vs correct) as predictor for ANC||1.01|0.84|0.0683
71120144|NCT01459653|141746006|SUPERIORITY_OR_OTHER||Slope|0.89||||0.0019|TWO_SIDED|95.0|0.82|0.96|||Regression, Logistic|degrees of freedom: 3181||GCSF decision (Over vs correct) as predictor for ANC||0.96|0.82|0.0019
71120145|NCT01459653|141746006|SUPERIORITY_OR_OTHER||Slope|1.04||||0.4469|TWO_SIDED|95.0|0.94|1.15|||Regression, Logistic|degrees of freedom: 3181||GCSF decision (Under vs over) as predictor for ANC||1.15|0.94|0.4469
71120146|NCT01459653|141746006|SUPERIORITY_OR_OTHER||Slope|1.11||||0.0079|TWO_SIDED|95.0|1.03|1.19|||Regression, Logistic|||Study drug dose (higher vs lower) as predictor for ANC||1.19|1.03|0.0079
71120147|NCT01459653|141746006|SUPERIORITY_OR_OTHER||Slope|0.81||||0.0004|TWO_SIDED|95.0|0.72|0.91|||Regression, Logistic|||Tumor type (hematological vs solid) as predictor for ANC||0.91|0.72|0.0004
71120148|NCT01459653|141746006|SUPERIORITY_OR_OTHER||Slope|0.86|||<|0.0001|TWO_SIDED|95.0|0.8|0.92|||Regression, Logistic|||Patient gender (female vs male) as predictor for ANC||0.92|0.80|<0.0001
71120149|NCT01459653|141746006|SUPERIORITY_OR_OTHER||Slope|1.04||||0.0235|TWO_SIDED|95.0|1.01|1.08|||Regression, Linear|||ECOG (per 1 point) as predictor for ANC||1.08|1.01|0.0235
71120150|NCT01459653|141746006|SUPERIORITY_OR_OTHER||Slope|1.03|||<|0.0001|TWO_SIDED|95.0|1.02|1.05|||Regression, Linear|||Hb (per g/dL) as predictor for ANC||1.05|1.02|<0.0001
71120151|NCT01459653|141746007|SUPERIORITY_OR_OTHER||Intra-class correlation coefficient|0.09||||0.0003|TWO_SIDED||||||ANCOVA||The intra-class correlation coefficient (ICC) was computed to quantify the variability in patient outcome attributable to within-center variability before any patient-level determinants are considered.|ANCOVA model was used taking into account center, patient within center-level and within-patient level (over time). This appendix describes the center-level.||||0.0003
71120152|NCT01459653|141746007|SUPERIORITY_OR_OTHER||Intra-class correlation coefficient|0.41|||<|0.0001|TWO_SIDED||||||ANCOVA|||ANCOVA model was used taking into account center, patient within center-level and within-patient level (over time). This appendix describes the patient within center-level.||||<0.0001
71120153|NCT01459653|141746007|SUPERIORITY_OR_OTHER||Intra-class correlation coefficient|0.5|||<|0.0001|TWO_SIDED||||||ANCOVA|||ANCOVA model was used taking into account center, patient within center-level and within-patient level (over time). This appendix describes the within-patient level.||||<0.0001
71120154|NCT01459653|141746012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.544||||0.003|TWO_SIDED|95.0|0.365|0.812|||Regression, Logistic|||GIS (1 vs. 0) as cycle-level predictor for CIN grade 4 episode||0.812|0.365|0.003
71120155|NCT01459653|141746012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.795|||<|0.001|TWO_SIDED|95.0|3.242|7.092|||Regression, Logistic|||Concomitant antibiotic prophylaxis as cycle-level predictor for CIN grade 4 episode||7.092|3.242|<0.001
71120156|NCT01459653|141746012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.083|||<|0.001|TWO_SIDED|95.0|3.242|7.092|||Regression, Logistic|||CIN1/4 in previous cycle as cycle-level predictor for CIN grade 4 episode||7.092|3.242|<0.001
71120157|NCT01459653|141746012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.46|||<|0.001|TWO_SIDED|95.0|1.542|3.925|||Regression, Logistic|||History of CIN Grade 4 at enrollment as patient-level predictor for CIN grade 4 episode||3.925|1.542|<0.001
71081066|NCT02373137|141668887|SUPERIORITY||Coefficient|-1.8|||<|0.001|TWO_SIDED|95.0|-2.8|-1.0|||Regression, Linear|Multiple linear regression model with a covariate for baseline visual acuity.|Coefficient reported in lines, comparing DMEK to UT-DSAEK. Compared to UT-DSAEK, DMEK had 1.8 lines better vision at 6 months.|||-1.0|-2.8|<0.001
71081067|NCT02373137|141668888|SUPERIORITY||Coefficient|-1.5||||0.002|TWO_SIDED|95.0|-2.5|-0.6|||Regression, Linear|Multiple linear regression model with a covariate for baseline visual acuity|Coefficient reported in lines, comparing DMEK to UT-DSAEK. Compared to UT-DSAEK, DMEK had 1.5 lines better vision at 3 months.|Comparison of 3-Month Visual Acuity Between Groups||-0.6|-2.5|0.002
71081068|NCT02373137|141668888|SUPERIORITY||Coefficient|-1.4|||<|0.001|TWO_SIDED|95.0|-2.2|-0.7|||Regression, Linear|Multiple linear regression model with a covariate for baseline visual acuity|Coefficient reported in lines, comparing DMEK to UT-DSAEK. Compared to UT-DSAEK, DMEK had 1.4 lines better vision at 12 months.|Comparison of 12 Month Visual Acuity Between Groups||-0.7|-2.2|<0.001
71081069|NCT02373137|141668890|SUPERIORITY||Coefficient|-77.0||||0.53|TWO_SIDED|95.0|-326.0|172.0|||t-test, 2 sided||Comparing DMEK to UT-DSAEK at 3 months.|||172|-326|0.53
71081070|NCT02373137|141668890|SUPERIORITY||Coefficient|-150.0||||0.17|TWO_SIDED|95.0|-356.0|66.0|||t-test, 2 sided||Comparing DMEK to UT-DSAEK at 6 months.|||66|-356|0.17
71120158|NCT01459653|141746012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.452||||0.003|TWO_SIDED|95.0|0.267|0.766|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for CIN grade 4 episode||0.766|0.267|0.003
71120159|NCT01459653|141746013|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.925||||0.001|TWO_SIDED|95.0|1.592|5.374|||Regression, Logistic|||History of CIN Grade 4 at enrollment as patient-level predictor for CIN grade 4 episode||5.374|1.592|0.001
71120160|NCT01459653|141746013|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.572||||0.005|TWO_SIDED|95.0|1.331|4.969|||Regression, Logistic|||Concomitant antibiotic prophylaxis as patient-level predictor for CIN grade 4 episode||4.969|1.331|0.005
71120161|NCT01459653|141746013|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.328|||<|0.001|TWO_SIDED|95.0|0.193|0.557|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for CIN grade 4 episode||0.557|0.193|<0.001
71120162|NCT01459653|141746014|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.673|||<|0.001|TWO_SIDED|95.0|1.284|2.179|||Regression, Logistic|||ECOG score (per 1 point) as cycle-level predictor for FN episode||2.179|1.284|<0.001
71120163|NCT01459653|141746014|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.704|||<|0.001|TWO_SIDED|95.0|2.777|7.968|||Regression, Logistic|||Concomitant antibiotic prophylaxis as cycle-level predictor for FN episode||7.968|2.777|<0.001
71120164|NCT01459653|141746014|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.002|TWO_SIDED|95.0|1.342|3.574|||Regression, Logistic|||CIN1/4 in previous cycle as cycle-level predictor for FN episode||3.574|1.342|0.002
70855005|NCT02880956|141198370|SUPERIORITY||LS Mean of Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.125||0.22|TWO_SIDED|95.0|-0.4|0.093||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.093|-0.400|0.220
70943754|NCT01037413|141387647|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.003|TWO_SIDED|95.0|-1.9|-0.4|||t-test, 2 sided|||Week 12, Pigmentation: Comparison within the participant between EXC 001 and placebo.||-0.4|-1.9|0.003
70943755|NCT01037413|141387647|SUPERIORITY||Mean Difference (Final Values)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.5|-0.8|||t-test, 2 sided|||Week 12, Thickness: Comparison within the participant between EXC 001 and placebo.||-0.8|-2.5|<0.001
71081071|NCT02373137|141668890|SUPERIORITY||Coefficient|-215.0||||0.051|TWO_SIDED|95.0|-430.0|-0.4|||t-test, 2 sided||Comparing DMEK to UT-DSAEK at 12 months.|||-0.4|-430|0.051
71081072|NCT02373137|141668896|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.70
71081073|NCT04388176|141668925|EQUIVALENCE|Differences in treatment groups in the primary endpoint (log (AUC)) was to be detected with a power of 90% and alpha=0.1.|Ratio in least square means|1.0146|||=|0.3801|TWO_SIDED|90.0|0.9859|1.0442|||ANCOVA|||||1.0442|0.9859|=0.3801
71081074|NCT04388176|141668926|EQUIVALENCE|Differences between treatment groups was to be detected with a power of 90% and alpha=0.1.|Ratio in least square means|1.0346|||=|0.0356|TWO_SIDED|90.0|1.0086|1.0613|||ANCOVA|||||1.0613|1.0086|=0.0356
71081075|NCT04388176|141668927|EQUIVALENCE|Differences between treatment groups was to be detected with a power of 90% and alpha=0.1.|Difference in least square means|-0.4991|||=|0.0154|TWO_SIDED|90.0|-0.8234|-0.1749|||ANCOVA|||Analysis at the 10 min point||-0.1749|-0.8234|=0.0154
71081076|NCT04388176|141668928|EQUIVALENCE|Differences between treatment groups was to be detected with a power of 90% and alpha=0.1.|Ratio in least square means|0.8301|||=|0.282|TWO_SIDED|90.0|0.6206|1.1102|||ANCOVA|||||1.1102|0.6206|=0.282
71081077|NCT04388176|141668929|EQUIVALENCE|Differences between treatment groups was to be detected with a power of 90% and alpha=0.1|Difference in least square means|-0.3989|||=|0.3722|TWO_SIDED|90.0|-1.1718|0.3739|||ANCOVA|||||0.3739|-1.1718|=0.3722
71081078|NCT04388176|141668930|EQUIVALENCE|Differences between treatment groups was to be detected with a power of 90% and alpha=0.1|Difference in least square means|-0.109|||=|0.4982|TWO_SIDED|90.0|-0.4074|0.1895|||ANCOVA|||Analysis of capillaroscopy before cold||0.1895|-0.4074|=0.4982
71081079|NCT04388176|141668930|EQUIVALENCE|A difference between treatment groups was detected with a power of 90% and alpha=0.1|Difference in least square means|-0.0637|||=|0.6219|TWO_SIDED|90.0|-0.3037|0.1763|||ANCOVA|||Analysis of capillaroscopy post recovery||0.1763|-0.3037|=0.6219
71081080|NCT03162328|141668952|SUPERIORITY|||||||0.363|||||||Wilcoxon Signed Ranks Test|||||||0.363
71081081|NCT03162328|141668953|SUPERIORITY|||||||0.291|||||||Wilcoxon Signed Ranks Test|||||||0.291
71120165|NCT01459653|141746014|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.215||||0.01|TWO_SIDED|95.0|0.067|0.687|||Regression, Logistic|||History of anaemia at enrollment as patient-level predictor for FN episode||0.687|0.067|0.010
71120166|NCT01459653|141746014|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.501||||0.025|TWO_SIDED|95.0|1.169|10.487|||Regression, Logistic|||Under- vs. over-prophylacted as patient-level predictor for FN episode||10.487|1.169|0.025
71120167|NCT01459653|141746015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.975||||0.003|TWO_SIDED|95.0|0.958|0.991|||Regression, Logistic|||Patient age (per 1 year) as patient-level predictor for FN episode||0.991|0.958|0.003
71120168|NCT01459653|141746015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.398|||<|0.001|TWO_SIDED|95.0|1.61|3.57|||Regression, Logistic|||ECOG ≥2 during study as patient-level predictor for FN episode||3.570|1.610|<0.001
71120169|NCT01459653|141746015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.562||||0.001|TWO_SIDED|95.0|1.45|4.527|||Regression, Logistic|||Concomitant antibiotic prophylaxis as patient-level predictor for FN episode||4.527|1.450|0.001
70855006|NCT02880956|141198370|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|0.85|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855007|NCT02880956|141198370|SUPERIORITY||LS Mean of Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.123||0.245|TWO_SIDED|95.0|-0.386|0.099||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.099|-0.386|0.245
70855008|NCT02880956|141198370|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|0.83|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855009|NCT02880956|141198370|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.127||0.569|TWO_SIDED|95.0|-0.323|0.178||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.178|-0.323|0.569
71081082|NCT00282152|141668963|NON_INFERIORITY|Because the purpose of this trial was to provide preliminary safety and tolerability data, the primary hypothesis was that the DBS+ODT group would not worsen more quickly than the ODT group. The primary endpoint was defined as the time to reach a four-point worsening of the UPDRS-III score following a one week treatment washout as assessed by the blinded rater.||||||0.968|||||||Log Rank|||||||0.968
71081083|NCT00282152|141668964|OTHER|||||||0.4|||||||t-test, 2 sided|||Study power was calculated based on the amount of PD medication consumed. We anticipated that the control group (ODT) would have a baseline value of 400 which would increase to 600, and that the treated group (DBS+ODT) would decrease from 400 to 300. A sample size of 12 patients per group (n=15, assuming 20% drop out) would have 80% power to detect a difference in means of 300 assuming that the common standard deviation is 250 using a two group t-test with a 0.05 two-sided significance level.||||0.40
71081084|NCT01124370|141668975|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The test was conducted using a 0.05 level of significance.|t-test, 2 sided|||The null hypothesis was that there would be no change in AHI from baseline.||||<.001
71081085|NCT03268005|141668982|NON_INFERIORITY|The upper limit of the 95% confidence interval for the difference between faster aspart and NovoRapid was compared to a non-inferiority margin of 0.4%. If it was below or equal to 0.4% non-inferiority was considered established and effect demonstrated.|Treatment difference|-0.04||||0.31|TWO_SIDED|95.0|-0.11|0.03|||ANOVA||Faster aspart-NovoRapid|Change from baseline in HbA1c was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model included treatment, region and metformin use at baseline (Yes/No) as factors, and baseline HbA1c as a covariate.||0.03|-0.11|0.310
71081086|NCT04378569|141669061|SUPERIORITY||Odds Ratio (OR)|1.11||||0.5788|TWO_SIDED|95.0|0.49|2.53|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data|Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data|||2.53|0.49|0.5788
71120170|NCT01459653|141746015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.232|||<|0.001|TWO_SIDED|95.0|0.108|0.499|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for FN episode||0.499|0.108|<0.001
71120171|NCT01459653|141746015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.261||||0.011|TWO_SIDED|95.0|1.315|8.084|||Regression, Logistic|||Under- vs. over-prophylacted as patient-level predictor for FN episode||8.084|1.315|0.011
71120172|NCT01459653|141746016|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.814|||<|0.001|TWO_SIDED|95.0|1.397|2.355|||Regression, Logistic|||ECOG score (per 1 point) as cycle-level predictor for CIN/FN-related hospitalization||2.355|1.397|<0.001
70855010|NCT02880956|141198370|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|0.95|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855011|NCT02880956|141198371|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.093||0.945|TWO_SIDED|95.0|-0.177|0.19||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.190|-0.177|0.945
70855012|NCT02880956|141198371|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|0.86|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70943756|NCT01037413|141387647|SUPERIORITY||Mean Difference (Final Values)|-1.8|||<|0.001|TWO_SIDED|95.0|-2.7|-1.0|||t-test, 2 sided|||Week 12, Relief: Comparison within the participant between EXC 001 and placebo.||-1.0|-2.7|<0.001
71081087|NCT04378569|141669061|SUPERIORITY||Odds Ratio (OR)|0.84||||0.6488|TWO_SIDED|95.0|0.33|2.17|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data|Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data|||2.17|0.33|0.6488
71081088|NCT04378569|141669061|SUPERIORITY||Odds Ratio (OR)|0.85||||0.5653|TWO_SIDED|95.0|0.32|2.25|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data|Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data|||2.25|0.32|0.5653
71081089|NCT04378569|141669062|SUPERIORITY||Odds Ratio (OR)|0.84||||0.5033|TWO_SIDED|95.0|0.25|2.78|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data|Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data|||2.78|0.25|0.5033
71081090|NCT04378569|141669062|SUPERIORITY||Odds Ratio (OR)|0.83||||0.4975|TWO_SIDED|95.0|0.25|2.79|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data|Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data|||2.79|0.25|0.4975
71120173|NCT01459653|141746016|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.296|||<|0.001|TWO_SIDED|95.0|1.791|6.065|||Regression, Logistic|||Concomitant antibiotic prophylaxis as cycle-level predictor for CIN/FN-related hospitalization||6.065|1.791|<0.001
70855013|NCT02880956|141198371|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.092||0.974|TWO_SIDED|95.0|-0.184|0.178||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.178|-0.184|0.974
70855014|NCT02880956|141198371|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|0.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855015|NCT02880956|141198371|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.094||0.963|TWO_SIDED|95.0|-0.19|0.181||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||||0.181|-0.190|0.963
70855016|NCT02880956|141198371|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|0.76|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855017|NCT02880956|141198371|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.104||0.625|TWO_SIDED|95.0|-0.255|0.154||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.154|-0.255|0.625
70855018|NCT02880956|141198371|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|0.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71081091|NCT04378569|141669062|SUPERIORITY||Odds Ratio (OR)|0.33|||||TWO_SIDED|95.0|0.04|2.55||P value was not evaluable|Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data|Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data|||2.55|0.04|
71081092|NCT04378569|141669063|SUPERIORITY||Odds Ratio (OR)|0.75||||0.7237|TWO_SIDED|95.0|0.23|2.44|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|||2.44|0.23|0.7237
71081093|NCT04378569|141669063|SUPERIORITY||Odds Ratio (OR)|0.59||||0.838|TWO_SIDED|95.0|0.17|2.1|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|||2.10|0.17|0.8380
71081094|NCT04378569|141669063|SUPERIORITY||Odds Ratio (OR)|0.33|||||TWO_SIDED|95.0|0.04|2.55||p-value was unevaluable||Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|||2.55|0.04|
70855019|NCT02880956|141198371|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.101||0.468|TWO_SIDED|95.0|-0.272|0.125||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.125|-0.272|0.468
70855020|NCT02880956|141198371|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|0.71|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855021|NCT02880956|141198371|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.104||0.636|TWO_SIDED|95.0|-0.155|0.254||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.254|-0.155|0.636
70855022|NCT02880956|141198371|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|0.88|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855023|NCT02880956|141198371|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.112||0.887|TWO_SIDED|95.0|-0.204|0.236||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.236|-0.204|0.887
70855024|NCT02880956|141198371|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|0.84|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855025|NCT02880956|141198371|SUPERIORITY||LS Mean of Difference|0.27|STANDARD_ERROR_OF_MEAN|0.111||0.016|TWO_SIDED|95.0|0.051|0.486||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.486|0.051|0.016
71081095|NCT04378569|141669064|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9604|TWO_SIDED|95.0|0.31|3.07|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 2||3.07|0.31|0.9604
71081096|NCT04378569|141669064|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9752|TWO_SIDED|95.0|0.32|3.25|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 2||3.25|0.32|0.9752
71081097|NCT04378569|141669064|SUPERIORITY||Odds Ratio (OR)|0.57||||0.5077|TWO_SIDED|95.0|0.11|3.03|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 2||3.03|0.11|0.5077
71081098|NCT04378569|141669064|SUPERIORITY||Odds Ratio (OR)|0.74||||0.5916|TWO_SIDED|95.0|0.26|2.15|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 4||2.15|0.26|0.5916
71081099|NCT04378569|141669064|SUPERIORITY||Odds Ratio (OR)|0.65||||0.332|TWO_SIDED|95.0|0.27|1.57|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 4||1.57|0.27|0.3320
71081100|NCT04378569|141669064|SUPERIORITY||Odds Ratio (OR)|0.47||||0.1922|TWO_SIDED|95.0|0.14|1.57|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 4||1.57|0.14|0.1922
71081101|NCT04378569|141669064|SUPERIORITY||Odds Ratio (OR)|0.65||||0.4188|TWO_SIDED|95.0|0.23|1.81|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 8||1.81|0.23|0.4188
71081102|NCT04378569|141669064|SUPERIORITY||Odds Ratio (OR)|0.74||||0.552|TWO_SIDED|95.0|0.29|1.92|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 8||1.92|0.29|0.5520
71120174|NCT01459653|141746016|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.205||||0.001|TWO_SIDED|95.0|1.38|3.524|||Regression, Logistic|||CIN1/4 in previous cycles as cycle-level predictor for CIN/FN-related hospitalization||3.524|1.380|0.001
71120175|NCT01459653|141746016|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.863||||0.032|TWO_SIDED|95.0|1.054|3.293|||Regression, Logistic|||Under- vs. correctly prophylacted as patient-level predictor for CIN/FN-related hospitalization||3.293|1.054|0.032
71120176|NCT01459653|141746016|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.385||||0.024|TWO_SIDED|95.0|0.168|0.879|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for CIN/FN-related hospitalization||0.879|0.168|0.024
71120177|NCT01459653|141746016|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.843||||0.001|TWO_SIDED|95.0|1.964|11.942|||Regression, Logistic|||Under- vs. over-prophylacted as patient-level predictor for CIN/FN-related hospitalization||11.942|1.964|0.001
71120178|NCT01459653|141746017|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.473|||<|0.001|TWO_SIDED|95.0|1.55|3.946|||Regression, Logistic|||ECOG ≥2 during study as patient-level predictor for CIN/FN-related hospitalization||3.946|1.550|<0.001
71120179|NCT01459653|141746017|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.382||||0.002|TWO_SIDED|95.0|0.21|0.695|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for CIN/FN-related hospitalization||0.695|0.210|0.002
71120180|NCT01459653|141746017|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.108||||0.001|TWO_SIDED|95.0|1.56|6.192|||Regression, Logistic|||Under- vs. over-prophylacted as patient-level predictor for CIN/FN-related hospitalization||6.192|1.560|0.001
71081103|NCT04378569|141669064|SUPERIORITY||Odds Ratio (OR)|0.69||||0.69|TWO_SIDED|95.0|0.21|2.2|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 8||2.20|0.21|0.69
71081104|NCT04378569|141669065|SUPERIORITY|Week 2|Mean Difference (Net)|-0.06||||0.6464|TWO_SIDED|95.0|-0.33|0.21|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|||0.21|-0.33|0.6464
71081105|NCT04378569|141669065|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.8881|TWO_SIDED|95.0|-0.29|0.25|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 2||0.25|-0.29|0.8881
71120181|NCT01459653|141746018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.931|||<|0.001|TWO_SIDED|95.0|5.426|14.699|||Regression, Logistic|||CIN1/4 in previous cycle as cycle-level predictor for CIN/FN-related chemotherapy disturbance||14.699|5.426|<0.001
71120182|NCT01459653|141746018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.336||||0.007|TWO_SIDED|95.0|0.152|0.74|||Regression, Logistic|||Hematological cancer (vs. oncologic) as patient-level predictor for CIN/FN-related chemotherapy disturbance||0.740|0.152|0.007
71120183|NCT01459653|141746018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.999||||0.006|TWO_SIDED|95.0|0.999|1.0|||Regression, Logistic|||Cancer patients seen in 2009 (per 1 patient) as center-level predictor for CIN/FN-related chemotherapy disturbance||1.000|0.999|0.006
71120184|NCT01459653|141746018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.001|||<|0.001|TWO_SIDED|95.0|1.0|1.001|||Regression, Logistic|||Chemotherapy-treated cancer patients in 2009 (per 1 patient) as center-level predictor for CIN/FN-related chemotherapy disturbance||1.001|1.000|<0.001
71120185|NCT01459653|141746018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.456||||0.024|TWO_SIDED|95.0|1.127|5.353|||Regression, Logistic|||Center type: academic vs non-academic as center-level predictor for CIN/FN-related chemotherapy disturbance||5.353|1.127|0.024
71120186|NCT01459653|141746018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.344||||0.01|TWO_SIDED|95.0|1.342|8.331|||Regression, Logistic|||Center type: academic-affiliated vs non-academic as center-level predictor for CIN/FN-related chemotherapy disturbance||8.331|1.342|0.010
71120187|NCT01459653|141746019|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.965||||0.006|TWO_SIDED|95.0|1.218|3.172|||Regression, Logistic|||Female gender as patient-level predictor for CIN/FN-related chemotherapy disturbance||3.172|1.218|0.006
70855026|NCT02880956|141198371|SUPERIORITY||Effect size/pooled SD|-0.33|STANDARD_DEVIATION|0.8|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855027|NCT02880956|141198371|SUPERIORITY||LS Mean of Difference|0.12|STANDARD_ERROR_OF_MEAN|0.112||0.272|TWO_SIDED|95.0|-0.097|0.342||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.342|-0.097|0.272
70855028|NCT02880956|141198371|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|0.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70943757|NCT01037413|141387647|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.012|TWO_SIDED|95.0|-1.9|-0.3|||t-test, 2 sided|||Week 12, Pliability: Comparison within the participant between EXC 001 and placebo.||-0.3|-1.9|0.012
70943758|NCT01037413|141387647|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.003|TWO_SIDED|95.0|-2.4|-0.5|||t-test, 2 sided|||Week 12, Surface Area: Comparison within the participant between EXC 001 and placebo.||-0.5|-2.4|0.003
70855029|NCT02880956|141198371|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.145||0.671|TWO_SIDED|95.0|-0.223|0.347||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.347|-0.223|0.671
70855030|NCT02880956|141198371|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|0.88|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70943759|NCT01037413|141387647|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.6|-1.1|||t-test, 2 sided|||Week 12, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||-1.1|-2.6|<0.001
70943760|NCT01037413|141387647|SUPERIORITY||Mean Difference (Final Values)|-8.4|||<|0.001|TWO_SIDED|95.0|-12.7|-4.0|||t-test, 2 sided|||Week 12, Composite Score: Comparison within the participant between EXC 001 and placebo.||-4.0|-12.7|<0.001
70943761|NCT01037413|141387647|SUPERIORITY||Mean Difference (Final Values)|-2.3|||<|0.001|TWO_SIDED|95.0|-3.2|-1.4|||t-test, 2 sided|||Week 24, Vascularity: Comparison within the participant between EXC 001 and placebo.||-1.4|-3.2|<0.001
71081106|NCT04378569|141669065|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.436|TWO_SIDED|95.0|-0.2|0.46|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 2||0.46|-0.20|0.4360
71081107|NCT04378569|141669065|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.8196|TWO_SIDED|95.0|-0.29|0.36|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 4||0.36|-0.29|0.8196
71120188|NCT01459653|141746019|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.594||||0.001|TWO_SIDED|95.0|1.469|4.581|||Regression, Logistic|||History of CIN4 at enrollment as patient-level predictor for CIN/FN-related chemotherapy disturbance||4.581|1.469|0.001
71120189|NCT01459653|141746020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.002|TWO_SIDED|95.0|0.424|0.821|||Regression, Logistic|||GIS (1 vs. 0) as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||0.821|0.424|0.002
71120190|NCT01459653|141746020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.644||||0.003|TWO_SIDED|95.0|0.489|0.859|||Regression, Logistic|||Zarzio duration: 4-5 days vs. 6 or more as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||0.859|0.489|0.003
71120191|NCT01459653|141746020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.579||||0.004|TWO_SIDED|95.0|0.398|0.842|||Regression, Logistic|||Zarzio duration: 1-3 days vs. 6 or more as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||0.842|0.398|0.004
71120192|NCT01459653|141746020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.369||||0.001|TWO_SIDED|95.0|1.14|1.643|||Regression, Logistic|||ECOG score (per 1 point) as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||1.643|1.140|0.001
71120193|NCT01459653|141746020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.499|||<|0.001|TWO_SIDED|95.0|2.456|4.985|||Regression, Logistic|||Concomitant antibiotic prophylaxis as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||4.985|2.456|<0.001
71120194|NCT01459653|141746020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.064|||<|0.001|TWO_SIDED|95.0|3.096|5.336|||Regression, Logistic|||CIN1/4 in previous cycle as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||5.336|3.096|<0.001
71120195|NCT01459653|141746020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.545||||0.002|TWO_SIDED|95.0|1.175|2.033|||Regression, Logistic|||Female gender as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||2.033|1.175|0.002
71120196|NCT01459653|141746020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.596||||0.017|TWO_SIDED|95.0|1.088|2.34|||Regression, Logistic|||History of CIN Grade 4 at enrollment as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||2.340|1.088|0.017
71120197|NCT01459653|141746021|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.621||||0.006|TWO_SIDED|95.0|1.152|2.281|||Regression, Logistic|||Female gender as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||2.281|1.152|0.006
71120198|NCT01459653|141746021|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.898||||0.005|TWO_SIDED|95.0|1.209|2.979|||Regression, Logistic|||History of CIN4 at enrollment as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||2.979|1.209|0.005
70855031|NCT02880956|141198371|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.143||0.493|TWO_SIDED|95.0|-0.183|0.378||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.378|-0.183|0.493
71120199|NCT01459653|141746021|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.68||||0.016|TWO_SIDED|95.0|1.2|5.984|||Regression, Logistic|||History of repeated infections at enrollment as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||5.984|1.200|0.016
71120200|NCT01459653|141746021|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.438|||<|0.001|TWO_SIDED|95.0|0.291|0.66|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||0.660|0.291|<0.001
71120201|NCT01459653|141746021|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.053||||0.002|TWO_SIDED|95.0|1.295|3.256|||Regression, Logistic|||Under- vs. over-prophylacted as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||3.256|1.295|0.002
71120202|NCT01459653|141746021|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.558||||0.028|TWO_SIDED|95.0|0.332|0.939|||Regression, Logistic|||GIS at enrollment (1 vs. 0) as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||0.939|0.332|0.028
71120203|NCT01459653|141746022|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2064||||0.0116|TWO_SIDED|95.0|1.1931|4.0803|||Regression, Logistic|||Patient level predictor: History of anemia at enrollment||4.0803|1.1931|0.0116
70943762|NCT01037413|141387647|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.9|-0.9|||t-test, 2 sided|||Week 24, Pigmentation: Comparison within the participant between EXC 001 and placebo.||-0.9|-2.9|<0.001
71081108|NCT04378569|141669065|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.9217|TWO_SIDED|95.0|-0.31|0.34|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 4||0.34|-0.31|0.9217
71081109|NCT04378569|141669065|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.4783|TWO_SIDED|95.0|-0.25|0.53|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|||0.53|-0.25|0.4783
70855032|NCT02880956|141198371|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|0.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70943763|NCT01037413|141387647|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.001|TWO_SIDED|95.0|-2.8|-0.8|||t-test, 2 sided|||Week 24, Thickness: Comparison within the participant between EXC 001 and placebo.||-0.8|-2.8|0.001
70943764|NCT01037413|141387647|SUPERIORITY||Mean Difference (Final Values)|-2.4|||<|0.001|TWO_SIDED|95.0|-3.6|-1.3|||t-test, 2 sided|||Week 24, Relief: Comparison within the participant between EXC 001 and placebo.||-1.3|-3.6|<0.001
71081110|NCT04378569|141669065|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.7725|TWO_SIDED|95.0|-0.32|0.43|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 8||0.43|-0.32|0.7725
71081111|NCT04378569|141669065|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.7861|TWO_SIDED|95.0|-0.43|0.33|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 8||0.33|-0.43|0.7861
71081112|NCT04378569|141669065|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.3521|TWO_SIDED|95.0|-0.24|0.68|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 8||0.68|-0.24|0.3521
71081113|NCT04378569|141669065|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.2166|TWO_SIDED|95.0|-0.62|0.14|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 12||0.14|-0.62|0.2166
71081114|NCT04378569|141669065|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.5262|TWO_SIDED|95.0|-0.52|0.27|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 12||0.27|-0.52|0.5262
71081115|NCT04378569|141669065|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.7575|TWO_SIDED|95.0|-0.39|0.54|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 12||0.54|-0.39|0.7575
70855033|NCT02880956|141198371|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.147||0.501|TWO_SIDED|95.0|-0.19|0.387||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.387|-0.190|0.501
70943765|NCT01037413|141387647|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.005|TWO_SIDED|95.0|-3.2|-0.7|||t-test, 2 sided|||Week 24, Pliability: Comparison within the participant between EXC 001 and placebo.||-0.7|-3.2|0.005
70943766|NCT01037413|141387647|SUPERIORITY||Mean Difference (Final Values)|-2.2|||<|0.001|TWO_SIDED|95.0|-3.1|-1.2|||t-test, 2 sided|||Week 24, Surface Area: Comparison within the participant between EXC 001 and placebo.||-1.2|-3.1|<0.001
71081116|NCT04378569|141669067|SUPERIORITY||Odds Ratio (OR)|1.73||||0.2662|TWO_SIDED|95.0|0.64|4.7|||Cochran-Mantel-Haenszel|Stratified|Stratified|Week 2||4.70|0.64|0.2662
71081117|NCT04378569|141669067|SUPERIORITY||Odds Ratio (OR)|1.54||||0.3798|TWO_SIDED|95.0|0.59|4.0|||Cochran-Mantel-Haenszel|||Week 2||4.00|0.59|0.3798
71081118|NCT04378569|141669067|SUPERIORITY||Odds Ratio (OR)|3.18||||0.0611|TWO_SIDED|95.0|0.9|11.17|||Cochran-Mantel-Haenszel|||Week 2||11.17|0.90|0.0611
71081119|NCT04378569|141669067|SUPERIORITY||Odds Ratio (OR)|1.58||||0.3129|TWO_SIDED|95.0|0.64|3.93|||Cochran-Mantel-Haenszel|||Week 4||3.93|0.64|0.3129
71081120|NCT04378569|141669067|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9586|TWO_SIDED|95.0|0.35|2.74|||Cochran-Mantel-Haenszel|||Week 4||2.74|0.35|0.9586
71081121|NCT04378569|141669067|SUPERIORITY||Odds Ratio (OR)|3.65||||0.0643|TWO_SIDED|95.0|0.87|15.29|||Cochran-Mantel-Haenszel|||Week 4||15.29|0.87|0.0643
71081122|NCT04378569|141669067|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0932|TWO_SIDED|95.0|0.84|6.88|||Cochran-Mantel-Haenszel|||Week 8||6.88|0.84|0.0932
71081123|NCT04378569|141669067|SUPERIORITY||Odds Ratio (OR)|1.42||||0.573|TWO_SIDED|95.0|0.44|4.59|||Cochran-Mantel-Haenszel|||Week 8||4.59|0.44|0.5730
71081124|NCT04378569|141669067|SUPERIORITY||Odds Ratio (OR)|4.96||||0.0389|TWO_SIDED|95.0|0.96|25.66|||Cochran-Mantel-Haenszel|||Week 8||25.66|0.96|0.0389
71081125|NCT04378569|141669067|SUPERIORITY||Odds Ratio (OR)|1.82||||0.2813|TWO_SIDED|95.0|0.6|5.53|||Cochran-Mantel-Haenszel|||Week 12||5.53|0.60|0.2813
71081126|NCT04378569|141669067|SUPERIORITY||Odds Ratio (OR)|0.72||||0.6841|TWO_SIDED|95.0|0.17|3.03|||Cochran-Mantel-Haenszel|||Week 12||3.03|0.17|0.6841
71081127|NCT04378569|141669067|SUPERIORITY||Odds Ratio (OR)|2.13||||0.3113|TWO_SIDED|95.0|0.49|9.21|||Cochran-Mantel-Haenszel|||Week 12||9.21|0.49|0.3113
71081128|NCT04378569|141669070|SUPERIORITY||Odds Ratio (OR)|2.21||||0.2674|TWO_SIDED|95.0|0.46|10.67|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 2||10.67|0.46|0.2674
71081129|NCT04378569|141669070|SUPERIORITY||Odds Ratio (OR)|2.78||||0.285|TWO_SIDED|95.0|0.44|17.54|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 2||17.54|0.44|0.2850
70943767|NCT01037413|141387647|SUPERIORITY||Mean Difference (Final Values)|-2.4|||<|0.001|TWO_SIDED|95.0|-3.3|-1.5|||t-test, 2 sided|||Week 24, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||-1.5|-3.3|<0.001
70943768|NCT01037413|141387647|SUPERIORITY||Mean Difference (Final Values)|-12.6|||<|0.001|TWO_SIDED|95.0|-17.7|-7.4|||t-test, 2 sided|||Week 24, Composite Score: Comparison within the participant between EXC 001 and placebo.||-7.4|-17.7|<0.001
70943769|NCT01037413|141387648|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.067|TWO_SIDED|95.0|-1.3|0.0|||t-test, 2 sided|||Week 12 Pain: Comparison within the participant between EXC 001 and placebo.||0.0|-1.3|0.067
70943770|NCT01037413|141387648|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.413|TWO_SIDED|95.0|-1.2|0.5|||t-test, 2 sided|||Week 12, Itching: Comparison within the participant between EXC 001 and placebo.||0.5|-1.2|0.413
70943771|NCT01037413|141387648|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.401|TWO_SIDED|95.0|-1.6|0.7|||t-test, 2 sided|||Week 12, Color: Comparison within the participant between EXC 001 and placebo.||0.7|-1.6|0.401
70943772|NCT01037413|141387648|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.083|TWO_SIDED|95.0|-2.4|0.2|||t-test, 2 sided|||Week 12, Stiffness: Comparison within the participant between EXC 001 and placebo.||0.2|-2.4|0.083
70943773|NCT01037413|141387648|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.052|TWO_SIDED|95.0|-2.3|0.0|||t-test, 2 sided|||Week 12, Thickness: Comparison within the participant between EXC 001 and placebo.||0.0|-2.3|0.052
70943774|NCT01037413|141387648|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.036|TWO_SIDED|95.0|-2.3|-0.1|||t-test, 2 sided|||Week 12, Irregular: Comparison within the participant between EXC 001 and placebo.||-0.1|-2.3|0.036
70943775|NCT01037413|141387648|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.045|TWO_SIDED|95.0|-2.1|0.0|||t-test, 2 sided|||Week 12, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||-0.0|-2.1|0.045
70943776|NCT01037413|141387648|SUPERIORITY||Mean Difference (Final Values)|-4.9||||0.054|TWO_SIDED|95.0|-9.9|0.1|||t-test, 2 sided|||Week 12, Composite Score: Comparison within the participant between EXC 001 and placebo.||0.1|-9.9|0.054
70943777|NCT01037413|141387648|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.065|TWO_SIDED|95.0|-8.2|0.3|||t-test, 2 sided|||Week 12, Scar Appearance Composite Score: Comparison within the participant between EXC 001 and placebo.||0.3|-8.2|0.065
70943778|NCT01037413|141387648|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.079|TWO_SIDED|95.0|-2.0|0.1|||t-test, 2 sided|||Week 24, Pain: Comparison within the participant between EXC 001 and placebo.||0.1|-2.0|0.079
70943779|NCT01037413|141387648|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.158|TWO_SIDED|95.0|-1.5|0.3|||t-test, 2 sided|||Week 24, Itching: Comparison within the participant between EXC 001 and placebo.||0.3|-1.5|0.158
70943780|NCT01037413|141387648|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.01|TWO_SIDED|95.0|-3.0|-0.5|||t-test, 2 sided|||Week 24, Color: Comparison within the participant between EXC 001 and placebo.||-0.5|-3.0|0.010
70943781|NCT01037413|141387648|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.003|TWO_SIDED|95.0|-3.5|-0.8|||t-test, 2 sided|||Week 24, Stiffness: Comparison within the participant between EXC 001 and placebo.||-0.8|-3.5|0.003
70943782|NCT01037413|141387648|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.005|TWO_SIDED|95.0|-4.0|-0.8|||t-test, 2 sided|||Week 24, Thickness: Comparison within the participant between EXC 001 and placebo.||-0.8|-4.0|0.005
70943783|NCT01037413|141387648|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.032|TWO_SIDED|95.0|-3.5|-0.2|||t-test, 2 sided|||Week 24, Irregular: Comparison within the participant between EXC 001 and placebo.||-0.2|-3.5|0.032
71120204|NCT01459653|141746022|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3049||||0.0057|TWO_SIDED|95.0|1.2754|4.1656|||Regression, Logistic|||Liver/renal/cardiac comorbidity as patient level predictor||4.1656|1.2754|0.0057
71120205|NCT01459653|141746022|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.535|||<|0.0001|TWO_SIDED|95.0|8.2159|37.4243|||Regression, Logistic|||Poor performance (ECOG \>=2) during study as patient level predictor||37.4243|8.2159|<0.0001
71120206|NCT01459653|141746026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.8703|||<|0.0001|TWO_SIDED|95.0|5.9567|37.1225|||Regression, Logistic|||Female gender as patient-level predictor for cancer-related mortality||37.1225|5.9567|<0.0001
71120207|NCT01459653|141746026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.8703|||<|0.0001|TWO_SIDED|95.0|5.9567|37.1225|||Regression, Logistic|||Poor performance (ECOG \>=2) during study as patient-level predictor||37.1225|5.9567|<0.0001
71120208|NCT03315104|141746117|SUPERIORITY|A median estimated value of 0.000 indicates no difference between groups.|Median Difference (Net)|0.0||||0.174|TWO_SIDED|95.0|0.0|1.0||No adjustment for multiple comparisons, two-sided significance level of 0.05|Wilcoxon (Mann-Whitney)|Exact test|FLU-IGIV High Dose (450 mL) - Placebo|Pairwise Wilcoxon rank-sum test for a location shift||1.000|0.000|0.174
71120209|NCT03315104|141746117|SUPERIORITY|A median estimated value of 0.000 indicates no difference between groups.|Mean Difference (Net)|0.0||||0.572|TWO_SIDED|95.0|0.0|1.0||No adjustment for multiple comparisons, two-sided significance level of 0.05|Wilcoxon (Mann-Whitney)|Exact test||Pairwise Wilcoxon rank-sum test for a location shift||1.000|0.000|0.572
71120210|NCT03315104|141746117|SUPERIORITY|A median estimated value of 0.000 indicates no difference between groups.|Median Difference (Net)|0.0||||0.534|TWO_SIDED|95.0|0.0|1.0||No adjustment for multiple comparisons. two-sided significance level of 0.05|Wilcoxon (Mann-Whitney)|Exact test||Pairwise Wilcoxon rank-sum test for a location shift||1.000|0.000|0.534
71120211|NCT03315104|141746117|SUPERIORITY|A median estimated value of 0.000 indicates no difference between groups.|Median Difference (Net)|0.0||||0.534|TWO_SIDED|95.0|0.0|1.0||No adjustment for multiple comparisons, two-sided significance level of 0.05|Wilcoxon (Mann-Whitney)|Exact test|FLU-IGIV pooled (450 mL + 250 mL) - Placebo|Pairwise Wilcoxon rank-sum test for a location shift where the two active dose groups were pooled and compared to placebo.||1.000|0.000|0.534
71120212|NCT00027378|141746118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39|STANDARD_DEVIATION|0.702||0.05||95.0|||||ANOVA|repeated measures||Repeated measures ANOVA||||.05
71120213|NCT03199053|141746148|SUPERIORITY||Adjusted mean difference|-1.03|STANDARD_ERROR_OF_MEAN|0.274|<|0.001|TWO_SIDED|95.0|-1.57|-0.49|||ANCOVA|||||-0.49|-1.57|< 0.001
71120214|NCT03199053|141746149|SUPERIORITY||Adjusted mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.251||0.078|TWO_SIDED|95.0|-0.93|0.05|||ANCOVA|||||0.05|-0.93|0.078
71120215|NCT03199053|141746150|SUPERIORITY||Adjusted mean difference|-0.86|STANDARD_ERROR_OF_MEAN|0.3||0.004|TWO_SIDED|95.0|-1.44|-0.27|||ANCOVA|||||-0.27|-1.44|0.004
71081130|NCT04378569|141669070|SUPERIORITY||Odds Ratio (OR)|2.63||||0.3086|TWO_SIDED|95.0|0.42|16.52|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 2||16.52|0.42|0.3086
71120216|NCT03199053|141746151|SUPERIORITY||Adjusted mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.277||0.067|TWO_SIDED|95.0|-1.05|0.04|||ANCOVA|||||0.04|-1.05|0.067
71120217|NCT03199053|141746152|SUPERIORITY||Adjusted mean difference|-1.19|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.76|-0.62|||ANCOVA|||||-0.62|-1.76|< 0.001
71120218|NCT03199053|141746153|SUPERIORITY||Adjusted mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.27||0.146|TWO_SIDED|95.0|-0.92|0.14|||ANCOVA|||||0.14|-0.92|0.146
71120219|NCT03199053|141746154|SUPERIORITY||Adjusted mean difference|-1.08|STANDARD_ERROR_OF_MEAN|0.479||0.024|TWO_SIDED|95.0|-2.02|-0.14|||ANCOVA|||||-0.14|-2.02|0.024
71120220|NCT03199053|141746155|SUPERIORITY||Adjusted mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.528||0.833|TWO_SIDED|95.0|-1.15|0.92|||ANCOVA|||||0.92|-1.15|0.833
71120221|NCT03199053|141746156|SUPERIORITY||Adjusted mean difference|-1.04|STANDARD_ERROR_OF_MEAN|0.525||0.047|TWO_SIDED|95.0|-2.07|-0.01|||ANCOVA|||||-0.01|-2.07|0.047
71120222|NCT03199053|141746157|SUPERIORITY||Adjusted mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.49||0.268|TWO_SIDED|95.0|-1.5|0.42|||ANCOVA|||||0.42|-1.50|0.268
71120223|NCT03199053|141746158|SUPERIORITY||Adjusted mean difference|-1.12|STANDARD_ERROR_OF_MEAN|0.505||0.026|TWO_SIDED|95.0|-2.11|-0.13|||ANCOVA|||||-0.13|-2.11|0.026
71120224|NCT03199053|141746159|SUPERIORITY||Adjusted mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.618||0.644|TWO_SIDED|95.0|-0.92|1.5|||ANCOVA|||||1.50|-0.92|0.644
71120225|NCT03199053|141746160|SUPERIORITY||Adjusted Odds Ratio|3.8||||0.019|TWO_SIDED|95.0|1.2|11.7|||Regression, Logistic|||||11.7|1.2|0.019
71120226|NCT03199053|141746160|SUPERIORITY||Adjusted Odds Ratio|2.6||||0.114|TWO_SIDED|95.0|0.8|8.6|||Regression, Logistic|||||8.6|0.8|0.114
71120227|NCT03199053|141746161|SUPERIORITY||Adjusted Odds Ratio|3.5||||0.042|TWO_SIDED|95.0|1.0|11.4|||Weighted Logistic Regression|||||11.4|1.0|0.042
71120228|NCT03199053|141746161|SUPERIORITY||Adjusted Odds Ratio|2.3||||0.175|TWO_SIDED|95.0|0.7|7.4|||Weighted Logistic Regression|||||7.4|0.7|0.175
71120229|NCT03199053|141746162|SUPERIORITY||Adjusted Odds Ratio|4.4||||0.009|TWO_SIDED|95.0|1.4|13.2|||Weighted Logistic Regression|||||13.2|1.4|0.009
71120230|NCT03199053|141746162|SUPERIORITY||Adjusted Odds Ratio|3.8||||0.042|TWO_SIDED|95.0|1.1|13.5|||Weighted Logistic Regression|||||13.5|1.1|0.042
71120231|NCT03199053|141746163|SUPERIORITY||Adjusted mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.496||0.955|TWO_SIDED|95.0|-1.0|0.94|||ANCOVA|||||0.94|-1.00|0.955
70855034|NCT02880956|141198371|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|0.98|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71081131|NCT04378569|141669070|SUPERIORITY||Odds Ratio (OR)|4.33||||0.1655|TWO_SIDED|95.0|0.46|40.83|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 4||40.83|0.46|0.1655
71081132|NCT04378569|141669070|SUPERIORITY||Odds Ratio (OR)|1.41||||0.7154|TWO_SIDED|95.0|0.26|7.67|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 4||7.67|0.26|0.7154
71120232|NCT03199053|141746163|SUPERIORITY||Adjusted mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.495||0.64|TWO_SIDED|95.0|-1.2|0.74|||ANCOVA|||||0.74|-1.20|0.640
71120233|NCT03199053|141746164|SUPERIORITY||Adjusted mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.896||0.476|TWO_SIDED|95.0|-2.39|1.12|||ANCOVA|||||1.12|-2.39|0.476
71120234|NCT03199053|141746164|SUPERIORITY||Adjusted mean difference|-1.81|STANDARD_ERROR_OF_MEAN|1.017||0.075|TWO_SIDED|95.0|-3.81|0.18|||ANCOVA|||||0.18|-3.81|0.075
71120235|NCT03199053|141746165|SUPERIORITY||Unadjusted Difference in Percentage|-19.7||||0.182|TWO_SIDED|95.0|-44.5|5.7|||Fisher Exact|||||5.7|-44.5|0.182
71120236|NCT03199053|141746166|SUPERIORITY||Unadjusted Difference in Percentage|-6.3||||0.65|TWO_SIDED|95.0|-29.8|16.5|||Fisher Exact|||||16.5|-29.8|0.650
71120237|NCT00246025|141746181|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-16.8||||0.0155||95.0|-30.2|-3.4||Multiplicity was not adjusted because of hierarchical testing from highest to lowest dose.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.|The risk differences are calculated as risk in the dabigatran groups minus risk in the placebo group.|Superiority of dabigatran etexilate to placebo was tested by means of hierarchical tests. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||-3.4|-30.2|0.0155
71120238|NCT00246025|141746181|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-23.7||||0.0006||95.0|-37.0|-10.5||Multiplicity was not adjusted because of hierarchical testing from highest to lowest dose.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.|The risk differences are calculated as risk in the dabigatran groups minus risk in the placebo group.|Superiority of dabigatran etexilate to placebo was tested by means of hierarchical tests. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||-10.5|-37.0|0.0006
71120239|NCT00246025|141746181|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-32.5|||<|0.0001||95.0|-45.4|-19.6||Multiplicity was not adjusted because of hierarchical testing from highest to lowest dose.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.|The risk differences are calculated as risk in the dabigatran groups minus risk in the placebo group.|Superiority of dabigatran etexilate to placebo was tested by means of hierarchical tests. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||-19.6|-45.4|<0.0001
71120240|NCT00246025|141746182|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0||||0.1124||95.0|-9.1|1.0||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||1.0|-9.1|0.1124
70943784|NCT01037413|141387648|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.003|TWO_SIDED|95.0|-3.8|-0.9|||t-test, 2 sided|||Week 24, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||-0.9|-3.8|0.003
70943785|NCT01037413|141387648|SUPERIORITY||Mean Difference (Final Values)|-9.8||||0.006|TWO_SIDED|95.0|-16.4|-3.1|||t-test, 2 sided|||Week 24, Composite Score: Comparison within the participant between EXC 001 and placebo.||-3.1|-16.4|0.006
70943786|NCT01037413|141387648|SUPERIORITY||Mean Difference (Final Values)|-8.2||||0.004|TWO_SIDED|95.0|-13.4|-3.0|||t-test, 2 sided|||Week 24, Scar Appearance Composite Score: Comparison within the participant between EXC 001 and placebo.||-3.0|-13.4|0.004
70943787|NCT00619983|141387655|SUPERIORITY|||||||0.69|||||||ANOVA|Repeated measures ANOVA||Due to failure of daily electronic diaries and exhaustion of funds, we were only able to recruit \< 30% of the number of subjects required in our power analysis.||||0.69
70943788|NCT00570921|141387666|SUPERIORITY_OR_OTHER||Median Time to Progression|7.4|||||TWO_SIDED|95.0|1.9|12.1||||||We hypothesized that median time to progression (TTP) in our trial will increase from 3.7 months for the historical fulvestrant-only control to 7.0 months on the combination of fulvestrant and everolimus in the current trial. A sample of 40 evaluable patients was calculated to show the increase in TTP with 80% power and 5% significance level based on a two sided test of differences in survival times between historical controls and treated group.||12.1|1.9|
70943789|NCT00570921|141387667|SUPERIORITY_OR_OTHER||Response Rate Percentage|12.9|||||TWO_SIDED|95.0|3.63|29.83|||||Percentage of Patients with a complete or partial response with 95% exact binomial proportion confidence interval|||29.83|3.63|
70943790|NCT00570921|141387668|SUPERIORITY_OR_OTHER||Percentage with clinical benefit|48.39|||||TWO_SIDED|95.0|30.15|66.94|||||Percentage of patients that had a complete response, partial response, or stable disease for 24 weeks or more as defined by RECIST v1.0.|||66.94|30.15|
70943791|NCT00784277|141387674|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|55.1|STANDARD_ERROR_OF_MEAN|20.37||0.007||95.0|15.11|95.13||P-value is adjusted for multiplicity for comparison against placebo using Hochberg's test.|ANCOVA|The model includes treatment and pooled center as factors and baseline pain intensity score as covariate.|The 95% confidence interval is unadjusted for multiplicity.|||95.13|15.11|0.007
70943792|NCT00784277|141387674|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|63.4|STANDARD_ERROR_OF_MEAN|20.23||0.004||95.0|23.67|103.13||P-value is adjusted for multiplicity for comparison against placebo using Hochberg's test.|ANCOVA|The model includes treatment and pooled center as factors and baseline pain intensity score as covariate.|The 95% confidence interval is unadjusted for multiplicity.|||103.13|23.67|0.004
71081133|NCT04378569|141669070|SUPERIORITY||Odds Ratio (OR)|2.0||||0.5371|TWO_SIDED|95.0|0.27|14.64|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 4||14.64|0.27|0.5371
71081134|NCT04378569|141669070|SUPERIORITY||Odds Ratio (OR)|5.0||||0.217|TWO_SIDED|95.0|0.43|57.83|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 8||57.83|0.43|0.2170
71081135|NCT04378569|141669070|SUPERIORITY||Odds Ratio (OR)|2.74||||0.3408|TWO_SIDED|95.0|0.41|18.22|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 8||18.22|0.41|0.3408
71120241|NCT00246025|141746182|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0||||0.1183||95.0|-9.1|1.1||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||1.1|-9.1|0.1183
70943793|NCT00784277|141387675|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|3.1|STANDARD_ERROR_OF_MEAN|0.46|<|0.001||95.0|2.22|4.01||P-value is adjusted for multiplicity for comparison against Oxycodone using Hochberg's test.|ANCOVA|The model includes treatment and pooled center as factors and baseline value as covariate.|The 95% confidence interval is unadjusted for multiplicity.|||4.01|2.22|<0.001
70943794|NCT00784277|141387675|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|2.2|STANDARD_ERROR_OF_MEAN|0.45|<|0.001||95.0|1.34|3.12||P-value is adjusted for multiplicity for comparison against Oxycodone using Hochberg's test.|ANCOVA|The model includes treatment and pooled center as factors and baseline value as covariate.|The 95% confidence interval is unadjusted for multiplicity.|||3.12|1.34|<0.001
70943795|NCT00784277|141387675|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|1.6|STANDARD_ERROR_OF_MEAN|0.45|<|0.001||95.0|0.72|2.5||P-value is adjusted for multiplicity for comparison against Oxycodone using Hochberg's test.|ANCOVA|The model includes treatment and pooled center as factors and baseline value as covariate.|The 95% confidence interval is unadjusted for multiplicity.|||2.50|0.72|<0.001
70943796|NCT00999141|141387684|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||two-sided paired t-test|alpha = 5%||||||<0.0001
70943797|NCT00999141|141387687|SUPERIORITY_OR_OTHER||Difference in Proportions|0.04||||0.257||95.0|-0.039|0.125|||McNemar|alpha = 5%|Difference in Proportions = (SoC) - (FS VH S/D 4 s-apr)|||0.125|-0.039|0.257
71081136|NCT04378569|141669070|SUPERIORITY||Odds Ratio (OR)|2.4||||0.327|TWO_SIDED|95.0|0.41|14.2|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 8||14.20|0.41|0.3270
71081137|NCT04378569|141669070|SUPERIORITY|||||||0.0719|||||||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade||Week 12||||0.0719
71081138|NCT04378569|141669070|SUPERIORITY||Odds Ratio (OR)|0.78||||0.8527|TWO_SIDED|95.0|0.07|8.43|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade||Week 12||8.43|0.07|0.8527
71081139|NCT04378569|141669070|SUPERIORITY||Odds Ratio (OR)|2.2||||0.3545|TWO_SIDED|95.0|0.37|13.11|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade||Week 12||13.11|0.37|0.3545
71081140|NCT04378569|141669071|SUPERIORITY||Mean Difference (Final Values)|-4.4||||0.0725|TWO_SIDED|95.0|-9.2|0.4|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 2||0.4|-9.2|0.0725
71081141|NCT04378569|141669071|SUPERIORITY||Mean Difference (Final Values)|-5.8||||0.0183|TWO_SIDED|95.0|-10.7|-1.0|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 2||-1.0|-10.7|0.0183
70943798|NCT00999141|141387688|SUPERIORITY_OR_OTHER||Difference in proportions|-0.373|||<|0.001||95.0|-0.524|-0.193|||McNemar|alpha = 5%|Difference in proportions = SoC - FS VH S/D 4 s-apr|||-0.193|-0.524|<0.001
70943799|NCT00999141|141387689|SUPERIORITY_OR_OTHER||Difference in proportions|-0.387|||<|0.001||95.0|-0.538|-0.205|||McNemar||Difference in Proportions = SoC - FS VH S/D 4 s-apr|||-0.205|-0.538|<0.001
70855035|NCT02880956|141198372|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.188||0.742|TWO_SIDED|95.0|-0.307|0.431||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.431|-0.307|0.742
70943800|NCT00999141|141387690|SUPERIORITY_OR_OTHER||Difference in proportions|-0.356||||0.001||95.0|-0.521|-0.161|||McNemar|alpha = 5%|Difference in proportions = SoC - FS VH S/D 4 s-apr|||-0.161|-0.521|0.001
70943801|NCT00999141|141387691|SUPERIORITY_OR_OTHER||Difference in proportions|-0.189||||0.027||95.0|-0.342|-0.023|||McNemar|alpha = 5%|Difference in proportions = SoC - FS VH S/D 4 s-apr|||-0.023|-0.342|0.027
70943802|NCT00999141|141387694|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.413||||||95.0|-0.577|-0.213|||||Difference in Proportions = (SoC) - (FS VH S/D 4 s-apr)|||-0.213|-0.577|
71081142|NCT04378569|141669071|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.5701|TWO_SIDED|95.0|-7.7|4.3|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables||Week 2||4.3|-7.7|0.5701
70943803|NCT00999141|141387695|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.227||||||95.0|-0.413|-0.02|||||Difference in Proportions = (SoC) - (FS VH S/D 4 s-apr)|||-0.020|-0.413|
71081143|NCT04378569|141669071|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.2116|TWO_SIDED|95.0|-10.4|2.3|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 4||2.3|-10.4|0.2116
71081144|NCT04378569|141669071|SUPERIORITY||Mean Difference (Final Values)|-5.1||||0.1235|TWO_SIDED|95.0|-11.5|1.4|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 4||1.4|-11.5|0.1235
71081145|NCT04378569|141669071|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.6334|TWO_SIDED|95.0|-9.7|5.9|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 4||5.9|-9.7|0.6334
71081146|NCT04378569|141669071|SUPERIORITY||Mean Difference (Final Values)|-4.6||||0.1788|TWO_SIDED|95.0|-11.4|2.1|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 8||2.1|-11.4|0.1788
71081147|NCT04378569|141669071|SUPERIORITY||Mean Difference (Final Values)|-7.6||||0.0292|TWO_SIDED|95.0|-14.4|-0.8|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 8||-0.8|-14.4|0.0292
71081148|NCT04378569|141669071|SUPERIORITY||Mean Difference (Final Values)|-8.8||||0.0371|TWO_SIDED|95.0|-17.1|-0.5|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 8||-0.5|-17.1|0.0371
71081149|NCT04378569|141669071|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.2971|TWO_SIDED|95.0|-11.3|3.5|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 12||3.5|-11.3|0.2971
71120242|NCT00246025|141746182|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-5.8||||0.0138||95.0|-10.3|-1.3||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||-1.3|-10.3|0.0138
70943804|NCT00999141|141387696|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.347||||||95.0|-0.518|-0.145|||||Difference in Proportions = (SoC) - (FS VH S/D 4 s-apr)|||-0.145|-0.518|
70943805|NCT00999141|141387697|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.365||||||95.0|-0.528|-0.171|||||Difference in Proportions = (SoC) - (FS VH S/D 4 s-apr)|||-0.171|-0.528|
71081150|NCT04378569|141669071|SUPERIORITY||Mean Difference (Final Values)|-9.5||||0.015|TWO_SIDED|95.0|-17.2|-1.9|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 12||-1.9|-17.2|0.0150
71081151|NCT04378569|141669071|SUPERIORITY||Mean Difference (Final Values)|-7.0||||0.1245|TWO_SIDED|95.0|-15.8|1.9|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 12||1.9|-15.8|0.1245
71081152|NCT04378569|141669071|SUPERIORITY||Mean Difference (Final Values)|-5.3||||0.1591|TWO_SIDED|95.0|-12.7|2.1|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 13||2.1|-12.7|0.1591
71081153|NCT04378569|141669071|SUPERIORITY||Mean Difference (Final Values)|-7.3||||0.06|TWO_SIDED|95.0|-14.8|0.3|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 13||0.3|-14.8|0.0600
71081154|NCT04378569|141669071|SUPERIORITY||Mean Difference (Final Values)|-3.3||||0.464|TWO_SIDED|95.0|-12.0|5.5|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 13||5.5|-12.0|0.4640
71081155|NCT04378569|141669072|SUPERIORITY||Mean Difference (Final Values)|-0.066||||0.3184|TWO_SIDED|95.0|-0.196|0.064|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 2||0.064|-0.196|0.3184
71081156|NCT04378569|141669072|SUPERIORITY||Mean Difference (Final Values)|-0.013||||0.8514|TWO_SIDED|95.0|-0.149|0.123|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 2||0.123|-0.149|0.8514
71081157|NCT04378569|141669072|SUPERIORITY||Mean Difference (Final Values)|0.091||||0.2603|TWO_SIDED|95.0|-0.068|0.249|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 2||0.249|-0.068|0.2603
71081158|NCT04378569|141669072|SUPERIORITY||Mean Difference (Final Values)|-0.171||||0.0273|TWO_SIDED|95.0|-0.323|-0.019|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 4||-0.019|-0.323|0.0273
71081159|NCT04378569|141669072|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.0266|TWO_SIDED|95.0|-0.339|-0.021|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 4||-0.021|-0.339|0.0266
71081160|NCT04378569|141669072|SUPERIORITY||Mean Difference (Final Values)|-0.012||||0.9023|TWO_SIDED|95.0|-0.196|0.173|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 4||0.173|-0.196|0.9023
71081161|NCT04378569|141669072|SUPERIORITY||Mean Difference (Final Values)|-0.096||||0.3298|TWO_SIDED|95.0|-0.291|0.098|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 8||0.098|-0.291|0.3298
70855036|NCT02880956|141198372|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.5|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855037|NCT02880956|141198372|SUPERIORITY||LS Mean of Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.185||0.431|TWO_SIDED|95.0|-0.511|0.218||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.218|-0.511|0.431
70855038|NCT02880956|141198372|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|1.5|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855039|NCT02880956|141198372|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.29|TWO_SIDED|95.0|-0.574|0.172||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.172|-0.574|0.290
71081162|NCT04378569|141669072|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.6205|TWO_SIDED|95.0|-0.251|0.15|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 8||0.150|-0.251|0.6205
70855040|NCT02880956|141198372|SUPERIORITY||effect size|0.13|STANDARD_DEVIATION|1.51|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70943806|NCT00413634|141387707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.092||95.0|||||ANOVA|||||||0.092
70943807|NCT00413634|141387710|SUPERIORITY_OR_OTHER_LEGACY|||||||0.857||95.0|||||ANOVA|||||||0.857
70943808|NCT00413634|141387711|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||95.0|||||ANOVA|||||||0.013
70943809|NCT00413634|141387712|SUPERIORITY_OR_OTHER_LEGACY|||||||0.378||95.0|||||ANOVA|||||||0.378
70943810|NCT00413634|141387713|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||95.0|||||ANOVA|||||||0.013
71120243|NCT00246025|141746183|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0||||0.1124||95.0|-9.1|1.0||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||1.0|-9.1|0.1124
71120244|NCT00246025|141746183|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0||||0.1183||95.0|-9.1|1.1||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||1.1|-9.1|0.1183
71120245|NCT00246025|141746183|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-5.8||||0.0138||95.0|-10.3|-1.3||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||-1.3|-10.3|0.0138
71120246|NCT00246025|141746184|SUPERIORITY_OR_OTHER|||||||0.6107||95.0||||Multiplicity was not adjusted.|Fisher Exact|||"Superiority of dabigatran etexilate to placebo was tested based on Fisher's exact test.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||||0.6107
71081163|NCT04378569|141669072|SUPERIORITY||Mean Difference (Final Values)|-0.018||||0.8817|TWO_SIDED|95.0|-0.253|0.217|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 8||0.217|-0.253|0.8817
71120247|NCT00246025|141746184|SUPERIORITY_OR_OTHER|||||||1||95.0||||Multiplicity was not adjusted.|Fisher Exact|||"Superiority of dabigatran etexilate to placebo was tested based on Fisher's exact test.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||||1.0000
71120248|NCT00246025|141746184|SUPERIORITY_OR_OTHER|||||||0.6162||95.0||||Multiplicity was not adjusted.|Fisher Exact|||"Superiority of dabigatran etexilate to placebo was tested based on Fisher's exact test.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||||0.6162
71120249|NCT00246025|141746185|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-16.8||||0.0155|TWO_SIDED|95.0|-30.2|-3.4||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||-3.4|-30.2|0.0155
70943811|NCT00413634|141387714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035||95.0|||||ANOVA|||||||0.035
70943812|NCT00413634|141387715|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023||95.0|||||ANOVA|||||||0.023
71120250|NCT00246025|141746185|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-23.7||||0.0006|TWO_SIDED|95.0|-37.0|-10.5||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||-10.5|-37.0|0.0006
71120251|NCT00246025|141746185|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-32.5|||<|0.0001|TWO_SIDED|95.0|-45.4|-19.6||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||-19.6|-45.4|<.0001
71120252|NCT00246025|141746188|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Placebo for the category major bleeding events||||1.0000
71120253|NCT00246025|141746188|SUPERIORITY_OR_OTHER|||||||0.496||95.0|||||Fisher Exact|||Comparison versus Placebo for the category major bleeding events||||0.4960
71120254|NCT00246025|141746188|SUPERIORITY_OR_OTHER|||||||0.6223||95.0|||||Fisher Exact|||Comparison versus Placebo for the category major bleeding events||||0.6223
71120255|NCT00246025|141746188|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|-2.5||||0.1513|TWO_SIDED|95.0|-5.9|1.0|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category major and clinically relevant bleeding events||1.0|-5.9|0.1513
70943813|NCT00413634|141387716|SUPERIORITY_OR_OTHER_LEGACY|||||||0.557||95.0|||||ANOVA|||||||0.557
70943814|NCT00413634|141387717|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027||95.0|||||ANOVA|||||||0.027
70943815|NCT00413634|141387718|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0|||||ANOVA|||||||0.007
71120256|NCT00246025|141746188|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|-2.4||||0.1696|TWO_SIDED|95.0|-5.9|1.0|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category major and clinically relevant bleeding events||1.0|-5.9|0.1696
71120257|NCT00246025|141746188|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|0.7||||0.7802|TWO_SIDED|95.0|-3.9|5.2|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category major and clinically relevant bleeding events||5.2|-3.9|0.7802
71120258|NCT00246025|141746188|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|1.7||||0.6313|TWO_SIDED|95.0|-5.3|8.7|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category any bleeding events||8.7|-5.3|0.6313
71120259|NCT00246025|141746188|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|2.3||||0.5377|TWO_SIDED|95.0|-4.9|9.4|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category any bleeding events||9.4|-4.9|0.5377
70943816|NCT00413634|141387719|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027||95.0|||||ANOVA|||||||0.027
70943817|NCT00413634|141387720|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011||95.0|||||ANOVA|||||||0.011
70943818|NCT02101268|141387763|SUPERIORITY||Proportion Difference - Stratified CMH|0.01||||0.9|TWO_SIDED|95.0|-0.09|0.1|||Cochran-Mantel-Haenszel|||||0.10|-0.09|0.90
70943819|NCT02101268|141387764|SUPERIORITY||Proportion Difference - Stratified CMH|0.2|||<|0.001|TWO_SIDED|95.0|0.09|0.32|||Cochran-Mantel-Haenszel|||||0.32|0.09|< 0.001
70943820|NCT02101268|141387765|SUPERIORITY||Rate ratio|0.8||||0.38|TWO_SIDED|95.0|0.49|1.31|||Negative Binomial Model, Adjusted||A smaller ratio represents larger benefit.|||1.31|0.49|0.38
70943821|NCT02101268|141387766|SUPERIORITY||Proportion Difference - Stratified CMH|0.23||||0.001|TWO_SIDED|95.0|0.09|0.37|||Cochran-Mantel-Haenszel||A larger proportion represents larger benefit.|||0.37|0.09|0.001
70943822|NCT02101268|141387767|SUPERIORITY||Proportion Difference - Stratified CMH|-0.13||||0.1|TWO_SIDED|95.0|-0.29|0.03|||Cochran-Mantel-Haenszel||A smaller proportion represents larger benefit.|||0.03|-0.29|0.10
70943823|NCT00740870|141387768|SUPERIORITY||Kaplan-Meier Rate|74.2|||<|0.0001|ONE_SIDED|95.0|67.1||||Z test||||||67.1|<0.0001
71120260|NCT00246025|141746188|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|2.8||||0.4493|TWO_SIDED|95.0|-4.4|10.0|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category any bleeding events||10.0|-4.4|0.4493
71120261|NCT00909545|141746192|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|2.03||0.9834|TWO_SIDED|95.0|-3.99|4.07||P-values for efficacy outcomes will be one-sided test with alpha = 0.05|ANCOVA|Analysis of covariance is used, with terms representing assigned treatment group and baseline value of the measure in the model.|Least square mean(standard error) and 95% confidence intervals of the difference between Isradipine CR 5mg and placebo groups is estimated.|Change in UPDRS total score of Isradipine CR 5mg/day arm is compared to placebo group.||4.07|-3.99|0.9834
71120262|NCT00909545|141746192|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|1.97||0.5761|TWO_SIDED|95.0|-5.01|2.8||P-values for efficacy outcomes will be one-sided test with alpha = 0.05|ANCOVA|Analysis of covariance is used, with terms representing assigned treatment group and baseline value of the measure in the model.|Least square mean(standard error) and 95% confidence intervals of the difference between Isradipine CR 10mg and placebo groups is estimated.|Change in UPDRS total score of Isradipine CR 10mg/day arm is compared to placebo group.||2.80|-5.01|0.5761
71120263|NCT00909545|141746192|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|STANDARD_ERROR_OF_MEAN|2.01||0.322|TWO_SIDED|95.0|-5.98|1.99||P-values for efficacy outcomes will be one-sided test with alpha = 0.05|ANCOVA|Analysis of covariance is used, with terms representing assigned treatment group and baseline value of the measure in the model|Least square mean(standard error) and 95% confidence intervals of the difference between Isradipine CR 20mg and placebo groups is estimated.|Change in UPDRS total score of Isradipine CR 20mg/day arm is compared to placebo group.||1.99|-5.98|0.322
71120264|NCT00909545|141746193|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.19|STANDARD_ERROR_OF_MEAN|1.1587||0.1383|TWO_SIDED|95.0|0.0196|1.8411|||Fisher Exact|||The tolerability of 5mg/day dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher's exact tests. No adjustment will be made for multiple comparisons in these analyses.||1.8411|0.0196|0.1383
71120265|NCT00909545|141746193|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1086|STANDARD_ERROR_OF_MEAN|0.1114||0.0248|TWO_SIDED|95.0|0.0123|0.9591|||Fisher Exact|||The tolerability of 10mg/day dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher's exact tests. No adjustment will be made for multiple comparisons in these analyses.||0.9591|0.0123|0.0248
71120266|NCT00909545|141746193|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.024|STANDARD_ERROR_OF_MEAN|1.1035|<|0.0001|TWO_SIDED|95.0|0.0028|0.2087|||Fisher Exact|||The tolerability of 20mg/day dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher's exact tests. No adjustment will be made for multiple comparisons in these analyses.||0.2087|0.0028|<0.0001
71120267|NCT00909545|141746194|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|STANDARD_ERROR_OF_MEAN|0.38||0.2324|TWO_SIDED|95.0|-0.3|1.22|||ANCOVA|||Change in Mental UPDRS subscale of Isradipine CR 5mg/day arm is compared to placebo group.||1.22|-0.30|0.2324
71120268|NCT00909545|141746194|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.37||1|TWO_SIDED|95.0|-0.73|0.73|||ANCOVA|||Change in Mental UPDRS subscale of Isradipine CR 10mg/day arm is compared to placebo group.||0.73|-0.73|1
71120269|NCT00909545|141746194|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.37||0.4675|TWO_SIDED|95.0|-1.02|0.47|||ANCOVA|||Change in Mental UPDRS subscale of Isradipine CR 20mg/day arm is compared to placebo group.||0.47|-1.02|0.4675
71120270|NCT00909545|141746195|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.82||0.4648|TWO_SIDED|95.0|-1.03|2.23|||ANCOVA|||Change in ADL UPDRS subscale of Isradipine CR 5mg/day arm is compared to placebo group.||2.23|-1.03|0.4648
71120271|NCT00909545|141746195|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.8||0.525|TWO_SIDED|95.0|-2.09|1.07|||ANCOVA|||Change in ADL UPDRS subscale of Isradipine CR 10mg/day arm is compared to placebo group.||1.07|-2.09|0.525
71120272|NCT00909545|141746195|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74|STANDARD_ERROR_OF_MEAN|0.81||0.3674|TWO_SIDED|95.0|-2.36|0.88|||ANCOVA|||Change in ADL UPDRS subscale of Isradipine CR 20mg/day arm is compared to placebo group.||0.88|-2.36|0.3674
71120273|NCT00909545|141746196|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.83|STANDARD_ERROR_OF_MEAN|1.5||0.579|TWO_SIDED|95.0|-3.8|2.14|||ANCOVA|||Change in Motor UPDRS subscale of Isradipine CR 5mg/day arm is compared to placebo group.||2.14|-3.80|0.579
71120274|NCT00909545|141746196|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|1.46||0.7778|TWO_SIDED|95.0|-3.3|2.48|||ANCOVA|||Change in Motor UPDRS subscale of Isradipine CR 10mg/day arm is compared to placebo group.||2.48|-3.30|0.7778
71120275|NCT00909545|141746196|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64|STANDARD_ERROR_OF_MEAN|1.48||0.669|TWO_SIDED|95.0|-3.58|2.31|||ANCOVA|||Change in Motor UPDRS subscale of Isradipine CR 20mg/day arm is compared to placebo group.||2.31|-3.58|0.669
71120276|NCT00909545|141746197|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.11||0.6677|TWO_SIDED|95.0|-0.27|0.17|||ANCOVA|||Change in Modified Hoehn \& Yahr Scale of Isradipine CR 5mg/day arm is compared to placebo group.||0.17|-0.27|0.6677
71120277|NCT00909545|141746197|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.11||0.1755|TWO_SIDED|95.0|-0.36|0.07|||ANCOVA|||Change in Modified Hoehn \& Yahr Scale of Isradipine CR 10mg/day arm is compared to placebo group.||0.07|-0.36|0.1755
71120278|NCT00909545|141746197|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.11||0.1463|TWO_SIDED|95.0|-0.38|0.06|||ANCOVA|||Change in Modified Hoehn \& Yahr Scale of Isradipine CR 20mg/day arm is compared to placebo group.||0.06|-0.38|0.1463
71120279|NCT00909545|141746198|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|1.4||0.7111|TWO_SIDED|95.0|-3.3|2.26|||ANCOVA|||Change in Modified Schwab \& England Independence Scale of Isradipine CR 5mg/day arm is compared to placebo group.||2.26|-3.30|0.7111
70855041|NCT02880956|141198372|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.191||0.541|TWO_SIDED|95.0|-0.492|0.258||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.258|-0.492|0.541
70855042|NCT02880956|141198372|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|1.55|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70954245|NCT00688870|141411076|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|4.45|||||TWO_SIDED|95.0|3.54|5.6|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 19A||5.60|3.54|
71081164|NCT04378569|141669072|SUPERIORITY||Mean Difference (Final Values)|-0.122||||0.1837|TWO_SIDED|95.0|-0.302|0.058|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 12||0.058|-0.302|0.1837
71081165|NCT04378569|141669072|SUPERIORITY||Mean Difference (Final Values)|-0.102||||0.2896|TWO_SIDED|95.0|-0.293|0.088|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|||0.088|-0.293|0.2896
71081166|NCT04378569|141669072|SUPERIORITY||Mean Difference (Final Values)|0.031||||0.919|TWO_SIDED|95.0|-0.205|0.227|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 12||0.227|-0.205|0.9190
71081167|NCT04560868|141669123|EQUIVALENCE|The point null hypothesis was a difference in expected number of log ins of exactly 0.|Mean Difference (Final Values)|12.73|||<|0.01|TWO_SIDED|95.0|6.41|19.05|||Regression, Linear||mean difference=experimental-control|Based on a priori power calculations we had 80% power to detect an average increase of 3.8 log ins in the experimental relative to the control arm.||19.05|6.41|<0.01
71081168|NCT04560868|141669124|EQUIVALENCE|The null hypothesis was a point null of relative risk equal to exactly 1.|Risk Ratio (RR)|1.01||||0.98|TWO_SIDED|95.0|0.55|1.85|||Regression, Poisson||relative risk=experimental/control|Based on a priori power calculations, we had 80% power to detect a 33% - 35% increase in the proportion of experimental participants who successfully quit smoking for at least 24 hours relative to controls.||1.85|0.55|0.98
71081169|NCT04560868|141669125|EQUIVALENCE|The null hypothesis was a point null of exactly 0 risk difference between arms.|Risk Difference (RD)|0.08||||0.35|TWO_SIDED|95.0|-0.08|0.24|||Regression, Linear||Risk difference = experimental - control.|Based on a priori power calculations, we had 80% power to detect a 28% - 33% increase in 7-day smoking abstinence in the experimental arm relative to the control arm at 3 months.||0.24|-0.08|0.35
71081170|NCT04560868|141669126|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in expected score between arms.|Mean Difference (Final Values)|0.26||||0.4|TWO_SIDED|95.0|-0.35|0.87|||Regression, Linear||mean difference=experimental-control|||0.87|-0.35|0.40
71081171|NCT04560868|141669127|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in expected score between arms.|Mean Difference (Final Values)|-0.04||||0.9|TWO_SIDED|95.0|-0.68|0.6|||Regression, Linear||mean difference=experimental-control|||0.60|-0.68|0.90
71081172|NCT04560868|141669128|EQUIVALENCE|The tested hypothesis was a point null of 0 difference in expected average helpfulness score between arms.|Mean Difference (Final Values)|0.4||||0.39|TWO_SIDED|95.0|-0.5|1.4|||Regression, Linear||mean difference=experimental-control|||1.4|-0.5|0.39
71081173|NCT04560868|141669129|EQUIVALENCE|The tested hypothesis was for a point null of 0 difference in expected average helpfulness score between arms.|Mean Difference (Final Values)|0.6||||0.11|TWO_SIDED|95.0|-0.1|1.3|||Regression, Linear||mean difference=experimental-control|||1.3|-0.1|0.11
71120280|NCT00909545|141746198|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.35|STANDARD_ERROR_OF_MEAN|1.36||0.3237|TWO_SIDED|95.0|-1.35|4.04|||ANCOVA|||Change in Modified Schwab \& England Independence Scale of Isradipine CR 10mg/day arm is compared to placebo group.||4.04|-1.35|0.3237
71120281|NCT00909545|141746198|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.27|STANDARD_ERROR_OF_MEAN|1.4||0.3658|TWO_SIDED|95.0|-1.51|4.05|||ANCOVA|||Change in Modified Schwab \& England Independence Scale of Isradipine CR 20mg/day arm is compared to placebo group.||4.05|-1.51|0.3658
71120282|NCT00909545|141746199|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5|STANDARD_ERROR_OF_MEAN|1.32||0.0608|TWO_SIDED|95.0|-0.12|5.13|||ANCOVA|||Change in BDI-II of Isradipine CR 5mg/day arm is compared to placebo group.||5.13|-0.12|0.0608
71120283|NCT00909545|141746199|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.63|STANDARD_ERROR_OF_MEAN|1.36||0.6445|TWO_SIDED|95.0|-2.07|3.33|||ANCOVA|||Change in BDI-II of Isradipine CR 10mg/day arm is compared to placebo group.||3.33|-2.07|0.6445
71120284|NCT00909545|141746199|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.02|STANDARD_ERROR_OF_MEAN|1.52||0.1336|TWO_SIDED|95.0|-0.63|4.67|||ANCOVA|||Change in BDI-II of Isradipine CR 20mg/day arm is compared to placebo group.||4.67|-0.63|0.1336
71120285|NCT00909545|141746200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.56||0.3533|TWO_SIDED|95.0|-1.64|0.59|||ANCOVA|||Change in Montreal Cognitive Assessment of Isradipine CR 5mg/day arm is compared to placebo group.||0.59|-1.64|0.3533
71120286|NCT00909545|141746200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47|STANDARD_ERROR_OF_MEAN|0.56||0.4045|TWO_SIDED|95.0|-1.59|0.65|||ANCOVA|||Change in Montreal Cognitive Assessment of Isradipine CR 10mg/day arm is compared to placebo group.||0.65|-1.59|0.4045
71120287|NCT00909545|141746200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.57||0.7049|TWO_SIDED|95.0|-1.36|0.92|||ANCOVA|||Change in Montreal Cognitive Assessment of Isradipine CR 20mg/day arm is compared to placebo group.||0.92|-1.36|0.7049
71120288|NCT00909545|141746201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.19|STANDARD_ERROR_OF_MEAN|1.8||0.2278|TWO_SIDED|95.0|-1.4|5.79|||ANCOVA|||Change in PDQ-39 of Isradipine CR 5mg/day arm is compared to placebo group.||5.79|-1.40|0.2278
71081174|NCT04560868|141669131|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in expected number of badges earned in each arm by 3 months post-baseline.|Mean Difference (Final Values)|4.2|||<|0.01|TWO_SIDED|95.0|1.72|6.65|||Regression, Linear||mean difference=experimental-control|||6.65|1.72|<0.01
70943824|NCT02831998|141387784|NON_INFERIORITY|Investigational product upper bounds must be less than 0.5.|Median Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.188|0.083||||||Groin 10 minutes Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and the predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||0.083|-0.188|
71081175|NCT04560868|141669132|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in expected score between arms.|Mean Difference (Final Values)|0.08||||0.96|TWO_SIDED|95.0|-1.02|1.18|||Regression, Linear||mean difference=experimental-control|||1.18|-1.02|0.96
71081176|NCT04560868|141669133|EQUIVALENCE|The null hypothesis was a point null hypothesis of exactly 0 difference in expected score between the arms.|Mean Difference (Final Values)|-0.44||||0.31|TWO_SIDED|95.0|-1.55|0.66|||Regression, Linear||mean difference=experimental-control|||0.66|-1.55|0.31
71081177|NCT04560868|141669137|EQUIVALENCE|The point null hypothesis was of the exact same proportion of control and experimental subjects requesting NRT.|Risk Ratio (RR)|3.9||||0.06|TWO_SIDED|95.0|0.9|16.9|||Regression, Poisson||RR=experimental/control|||16.9|0.9|0.06
71081178|NCT04560868|141669138|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in probability of the outcome between arms.|Risk Ratio (RR)|1.01||||0.99|TWO_SIDED|95.0|0.38|2.65|||Regression, Poisson||risk ratio=experimental/control|||2.65|0.38|0.99
71081179|NCT04560868|141669139|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in expected change from baseline in number of cigarettes smoked per day between arms.|Mean Difference (Net)|1.39||||0.3|TWO_SIDED|95.0|-1.21|3.99|||Regression, Linear||treatment difference=experimental-control, where the outcome for each individual is (one month)-baseline.|||3.99|-1.21|0.30
71081180|NCT04560868|141669140|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in expected change in daily cigarette usage between arms.|Mean Difference (Net)|1.5||||0.47|TWO_SIDED|95.0|-2.51|5.5|||Regression, Linear||treatment effect=experimental-control, where the outcome for each individual is (three month)-baseline.|||5.5|-2.51|0.47
71081181|NCT04560868|141669141|EQUIVALENCE|The null hypothesis was risk difference of exactly 0.|Risk Difference (RD)|0.04||||0.3|TWO_SIDED|95.0|-0.03|0.11|||Regression, Linear||risk difference=experimental-control|||0.11|-0.03|0.30
71120289|NCT00909545|141746201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.72|STANDARD_ERROR_OF_MEAN|1.86||0.356|TWO_SIDED|95.0|-1.97|5.42|||ANCOVA|||Change in PDQ-39 of Isradipine CR 5mg/day arm is compared to placebo group.||5.42|-1.97|0.356
71120290|NCT00909545|141746201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.07|STANDARD_ERROR_OF_MEAN|1.83||0.26|TWO_SIDED|95.0|-1.56|5.71|||ANCOVA|||Change in PDQ-39 of Isradipine CR 20mg/day arm is compared to placebo group.||5.71|-1.56|0.2600
71120291|NCT00909545|141746208|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.2632|STANDARD_ERROR_OF_MEAN|1.159||0.1384|TWO_SIDED|95.0|0.5432|50.9977||The analysis of common AE of each active dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher's exact tests. No adjustment will be made for multiple comparisons in these analyses.|Fisher Exact|||The analyses is to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Oedema Peripheral.||50.9977|0.5432|0.1384
70943825|NCT02831998|141387784|SUPERIORITY|Investigational product lower bounds must be greater than 1.2.|Median Difference (Final Values)|2.627|||||TWO_SIDED|95.0|2.396|2.858||||||Groin 10 minutes Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||2.858|2.396|
70954246|NCT00688870|141411077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.735||95.0|||||Fisher Exact|||For Tenderness - Any, Fisher exact test was used to calculate p-value.||||0.735
71081182|NCT04727528|141669142|SUPERIORITY||Odds Ratio (OR)|56.2||||0.001|TWO_SIDED|95.0|5.6|563.6|||Wald Chi-Squared test||Logistic regression model included response status (response / non-response) as the dependent variable and randomized treatment as an independent factor.|||563.6|5.6|0.001
71081183|NCT04727528|141669143|SUPERIORITY||Least-squares mean|1.64|STANDARD_ERROR_OF_MEAN|0.81||0.05|TWO_SIDED|95.0|0.0|3.29|||t-test, 2 sided|||Difference between groups||3.29|-0.00|0.050
71081184|NCT04727528|141669144|SUPERIORITY||Odds Ratio (OR)|3.2||||0.153|TWO_SIDED|95.0|0.6|15.8|||Wald Chi-Squared test|||Comparison between groups||15.8|0.6|0.153
71081185|NCT04727528|141669145|SUPERIORITY||Odds Ratio (OR)|57008.6||||0.94|TWO_SIDED|95.0|0.0||The upper limit of the 95% confidence interval = 13124060000000000000000000000||Wald Chi-Squared test|||Comparison between groups|||0.0|0.940
71081186|NCT04727528|141669146|SUPERIORITY||Odds Ratio (OR)|2.2||||0.271|TWO_SIDED|95.0|0.5|8.6|||Wald Chi-Squared test|||Comparison between groups||8.6|0.5|0.271
71081187|NCT04727528|141669147|SUPERIORITY||Odds Ratio (OR)|10.8||||0.039|TWO_SIDED|95.0|1.1|102.8|||Wald Chi-Squared test|||Comparison between groups||102.8|1.1|0.039
71081188|NCT04727528|141669148|SUPERIORITY||Odds Ratio (OR)|57008.6||||0.94|TWO_SIDED|95.0|0.0||The upper limit of the 95% confidence interval = 13124060000000000000000000000||Wald Chi-Squared test|||Comparison between groups|||0.0|0.940
71081189|NCT01763827|141669150|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.14|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-61.14|-53.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-53.14|-61.14|<0.001
71081190|NCT01763827|141669150|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.78|STANDARD_ERROR_OF_MEAN|1.87|<|0.001|TWO_SIDED|95.0|-58.46|-51.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-51.10|-58.46|<0.001
71081191|NCT01763827|141669150|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.29|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-43.28|-35.31||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-35.31|-43.28|<0.001
71120292|NCT00909545|141746208|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|15.625|STANDARD_ERROR_OF_MEAN|1.097||0.0024|TWO_SIDED|95.0|1.8214|134.0403||The analysis of common AE of each active dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher's exact tests. No adjustment will be made for multiple comparisons in these analyses.|Fisher Exact|||Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Oedema Peripheral.||134.0403|1.8214|0.0024
70855043|NCT02880956|141198372|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.186||0.617|TWO_SIDED|95.0|-0.459|0.272||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.272|-0.459|0.617
70943826|NCT02831998|141387785|NON_INFERIORITY|Investigational product average treatment effect upper bounds cannot be more than 0.5.|Mean Difference (Final Values)|-0.018|||||TWO_SIDED|95.0|-0.102|0.065||||||Abdomen 10 minutes Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||0.065|-0.102|
71120293|NCT00909545|141746208|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|50.0|STANDARD_ERROR_OF_MEAN|1.108|<|0.0001|TWO_SIDED|95.0|5.7004|438.5694||The analysis of common AE of each active dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher's exact tests. No adjustment will be made for multiple comparisons in these analyses.|Fisher Exact|||Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Oedema Peripheral.||438.5694|5.7004|<.0001
71120294|NCT00909545|141746209|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.754|STANDARD_ERROR_OF_MEAN|0.6715||0.7735|TWO_SIDED|95.0|0.2022|2.812|||Fisher Exact|||one-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dizziness.||2.8120|0.2022|0.7735
71120295|NCT00909545|141746209|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8143|STANDARD_ERROR_OF_MEAN|0.6419||0.7385|TWO_SIDED|95.0|0.2314|2.8658|||Fisher Exact|||one-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dizziness.||2.8658|0.2314|0.7385
71120296|NCT00909545|141746209|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9048|STANDARD_ERROR_OF_MEAN|0.6463||0.6823|TWO_SIDED|95.0|0.2549|3.2112|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dizziness.||3.2112|0.2549|0.6823
71120297|NCT00909545|141746210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5263|STANDARD_ERROR_OF_MEAN|0.9188||0.2756|TWO_SIDED|95.0|0.4172|15.2975|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nasopharyngitis.||15.2975|0.4172|0.2756
71120298|NCT00909545|141746210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4211|STANDARD_ERROR_OF_MEAN|0.8584||0.07|TWO_SIDED|95.0|0.8217|23.7875|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nasopharyngitis.||23.7875|0.8217|0.07
71120299|NCT00909545|141746210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|STANDARD_ERROR_OF_MEAN|0.9174||0.2953|TWO_SIDED|95.0|0.3975|14.4919|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nasopharyngitis.||14.4919|0.3975|0.2953
71120300|NCT00909545|141746211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15|STANDARD_ERROR_OF_MEAN|0.8719||0.6049|TWO_SIDED|95.0|0.2082|6.3508|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Headache.||6.3508|0.2082|0.6049
71120301|NCT00909545|141746211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|STANDARD_ERROR_OF_MEAN|0.7704||0.2327|TWO_SIDED|95.0|0.5081|10.4105|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Headache.||10.4105|0.5081|0.2327
71120302|NCT00909545|141746211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5333|STANDARD_ERROR_OF_MEAN|0.8227||0.4534|TWO_SIDED|95.0|0.3057|7.6897|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Headache.||7.6897|0.3057|0.4534
71120303|NCT00909545|141746212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7302|STANDARD_ERROR_OF_MEAN|0.9616||0.7852|TWO_SIDED|95.0|0.1109|4.8065|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Constipation.||4.8065|0.1109|0.7852
70855044|NCT02880956|141198372|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70943827|NCT02831998|141387785|SUPERIORITY|Investigational product lower bounds must be greater than 1.2.|Mean Difference (Final Values)|1.909|||||TWO_SIDED|95.0|1.766|2.053||||||Abdomen 10 minutes Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||2.053|1.766|
70855045|NCT02880956|141198372|SUPERIORITY||LS Mean of Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.191||0.457|TWO_SIDED|95.0|-0.517|0.233||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.233|-0.517|0.457
70855046|NCT02880956|141198372|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|1.5|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855047|NCT02880956|141198372|SUPERIORITY||LS Mean of Difference|0.22|STANDARD_ERROR_OF_MEAN|0.188||0.245|TWO_SIDED|95.0|-0.151|0.59||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.590|-0.151|0.245
70855048|NCT02880956|141198372|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|1.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855049|NCT02880956|141198372|SUPERIORITY||LS Mean of Difference|0.13|STANDARD_ERROR_OF_MEAN|0.187||0.491|TWO_SIDED|95.0|-0.238|0.496||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.496|-0.238|0.491
70855050|NCT02880956|141198372|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|1.6|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855051|NCT02880956|141198372|SUPERIORITY||LS Mean of Difference|0.28|STANDARD_ERROR_OF_MEAN|0.188||0.132|TWO_SIDED|95.0|-0.085|0.652||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.652|-0.085|0.132
70943828|NCT00839332|141387787|SUPERIORITY_OR_OTHER||Bayesian Posterior Probability|0.333|||||TWO_SIDED||||||||Inference about survival was made using a Bayesian posterior probability. The combination treatment would have been considered superior to gemcitabine alone if the posterior probability of superiority exceeded 0.8.|||||
70954247|NCT00688870|141411077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.533||95.0|||||Fisher Exact|||For Tenderness - Significant, Fisher exact test was used to calculate p-value.||||0.533
71120304|NCT00909545|141746212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|0.8681||0.666|TWO_SIDED|95.0|0.1824|5.482|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Constipation.||5.4820|0.1824|0.666
70855052|NCT02880956|141198372|SUPERIORITY||Effect size/pooled SD|-0.18|STANDARD_DEVIATION|1.58|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855053|NCT02880956|141198372|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.19||0.751|TWO_SIDED|95.0|-0.434|0.313||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.313|-0.434|0.751
70855054|NCT02880956|141198372|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|1.53|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70943829|NCT03569475|141387805|SUPERIORITY||Least Square Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|1.41||0.2215|TWO_SIDED|95.0|-4.49|1.04|||Mixed Model for Repeated Measures||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and Baseline and Baseline-by-visit as covariates using an unstructured covariance matrix.|||1.04|-4.49|0.2215
71120305|NCT00909545|141746212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5333|STANDARD_ERROR_OF_MEAN|0.8227||0.4534|TWO_SIDED|95.0|0.3057|7.6897|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Constipation.||7.6897|0.3057|0.4534
71120306|NCT00909545|141746213|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5455|STANDARD_ERROR_OF_MEAN|1.2596||0.8589|TWO_SIDED|95.0|0.0462|6.4433|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Fatigue.||6.4433|0.0462|0.8589
71120307|NCT00909545|141746213|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5652|STANDARD_ERROR_OF_MEAN|0.9584||0.5|TWO_SIDED|95.0|0.2392|10.241|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Fatigue.||10.2410|0.2392|0.5000
71120308|NCT00909545|141746213|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7143|STANDARD_ERROR_OF_MEAN|0.9605||0.4609|TWO_SIDED|95.0|0.2609|11.2639|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Fatigue.||11.2639|0.2609|0.4609
71120309|NCT00909545|141746214|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7302|STANDARD_ERROR_OF_MEAN|0.9616||0.7852|TWO_SIDED|95.0|0.1109|4.8065|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nausea.||4.8065|0.1109|0.7852
71120310|NCT00909545|141746214|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3067|STANDARD_ERROR_OF_MEAN|1.1912||0.9448|TWO_SIDED|95.0|0.0297|3.1612|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nausea.||3.1612|0.0297|0.9448
70855055|NCT02880956|141198372|SUPERIORITY||LS Mean of Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.188||0.157|TWO_SIDED|95.0|-0.635|0.103||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.103|-0.635|0.157
70855056|NCT02880956|141198372|SUPERIORITY||Effect size/pooled SD|0.16|STANDARD_DEVIATION|1.63|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71120311|NCT00909545|141746214|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.697|STANDARD_ERROR_OF_MEAN|0.9604||0.7996|TWO_SIDED|95.0|0.1061|4.5779|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nausea.||4.5779|0.1061|0.7996
71120312|NCT00909545|141746215|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.381|STANDARD_ERROR_OF_MEAN|1.2599||0.4532|TWO_SIDED|95.0|0.2015|28.1366|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Tract Infection.||28.1366|0.2015|0.4532
71120313|NCT00909545|141746215|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.9524|STANDARD_ERROR_OF_MEAN|1.1347||0.0953|TWO_SIDED|95.0|0.6439|55.0272|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Tract Infection.||55.0272|0.6439|0.0953
71120314|NCT00909545|141746216|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|STANDARD_ERROR_OF_MEAN|0.9617||0.4402||95.0|0.2733|11.8558|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Depression.||11.8558|0.2733|0.4402
71120315|NCT00909545|141746216|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48|STANDARD_ERROR_OF_MEAN|1.2577||0.8824|TWO_SIDED|95.0|0.0408|5.6461|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Depression.||5.6461|0.0408|0.8824
71120316|NCT00909545|141746216|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0909|STANDARD_ERROR_OF_MEAN|1.0428||0.6641|TWO_SIDED|95.0|0.1413|8.4197|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Depression.||8.4197|0.1413|0.6641
70855057|NCT02880956|141198372|SUPERIORITY||LS Mean of Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.192||0.283|TWO_SIDED|95.0|-0.585|0.172||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.172|-0.585|0.283
70954248|NCT00688870|141411077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||95.0|||||Fisher Exact|||For Swelling - Any, Fisher exact test was used to calculate p-value.||||0.039
70954249|NCT00688870|141411077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.059||95.0|||||Fisher Exact|||For Swelling - Mild, Fisher exact test was used to calculate p-value.||||0.059
71120317|NCT00909545|141746217|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|STANDARD_ERROR_OF_MEAN|0.9617||0.4402|TWO_SIDED|95.0|0.2733|11.8558|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Somnolence.||11.8558|0.2733|0.4402
71120318|NCT00909545|141746217|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|1.0409||0.6951|TWO_SIDED|95.0|0.13|7.6906|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Somnolence.||7.6906|0.1300|0.6951
71120319|NCT00909545|141746218|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|STANDARD_ERROR_OF_MEAN|0.9617||0.4402|TWO_SIDED|95.0|0.2733|11.8558|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Insomnia .||11.8558|0.2733|0.4402
71120320|NCT00909545|141746218|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48|STANDARD_ERROR_OF_MEAN|1.2577||0.8824|TWO_SIDED|95.0|0.0408|5.6461|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Insomnia .||5.6461|0.0408|0.8824
71120321|NCT00909545|141746218|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5217|STANDARD_ERROR_OF_MEAN|1.2594||0.8673|TWO_SIDED|95.0|0.0442|6.1537|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Insomnia .||6.1537|0.0442|0.8673
71120322|NCT00909545|141746219|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3485|STANDARD_ERROR_OF_MEAN|1.1919||0.9294|TWO_SIDED|95.0|0.0337|3.6084|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dyspepsia .||3.6084|0.0337|0.9294
71120323|NCT00909545|141746219|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3067|STANDARD_ERROR_OF_MEAN|1.1912||0.9448|TWO_SIDED|95.0|0.0297|3.1612|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dyspepsia .||3.1612|0.0297|0.9448
71120324|NCT00909545|141746219|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3333|STANDARD_ERROR_OF_MEAN|1.1924||0.9351|TWO_SIDED|95.0|0.0322|3.4459|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dyspepsia .||3.4459|0.0322|0.9351
71120325|NCT00909545|141746220|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5455|STANDARD_ERROR_OF_MEAN|1.2596||0.8589|TWO_SIDED|95.0|0.0462|6.4433|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Diarrhoea.||6.4433|0.0462|0.8589
71120326|NCT00909545|141746220|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|1.0409||0.6951|TWO_SIDED|95.0|0.13|7.6906|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Diarrhoea.||7.6906|0.1300|0.6951
71120327|NCT00909545|141746220|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5217|STANDARD_ERROR_OF_MEAN|1.2594||0.8673|TWO_SIDED|95.0|0.0442|6.1537|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Diarrhoea.||6.1537|0.0442|0.8673
71120328|NCT00909545|141746221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7302|STANDARD_ERROR_OF_MEAN|0.9616||0.7852|TWO_SIDED|95.0|0.1109|4.8065|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Sinusitis.||4.8065|0.1109|0.7852
71120329|NCT00909545|141746221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3067|STANDARD_ERROR_OF_MEAN|1.1912||0.9448|TWO_SIDED|95.0|0.0297|3.1612|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Sinusitis.||3.1612|0.0297|0.9448
70954250|NCT00688870|141411077|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Swelling - Moderate, Fisher exact test was used to calculate p-value.||||>0.99
71120330|NCT00909545|141746222|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0833|STANDARD_ERROR_OF_MEAN|1.2576||0.5|TWO_SIDED|95.0|0.1771|24.5057|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Back Pain.||24.5057|0.1771|0.5000
71120331|NCT00909545|141746222|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.5714|STANDARD_ERROR_OF_MEAN|1.192||0.2746|TWO_SIDED|95.0|0.3453|36.9408|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Back Pain.||36.9408|0.3453|0.2746
70855058|NCT02880956|141198372|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|1.44|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855059|NCT02880956|141198373|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.363|TWO_SIDED|95.0|-0.085|0.231||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.231|-0.085|0.363
70855060|NCT02880956|141198373|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|0.66|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70954251|NCT00688870|141411077|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Redness - Any, Fisher exact test was used to calculate p-value.||||>0.99
70943830|NCT03569475|141387805|SUPERIORITY||Least Square Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|1.41||0.1964|TWO_SIDED|95.0|-4.59|0.95|||Mixed Model for Repeated Measures||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and Baseline and Baseline-by-visit as covariates using an unstructured covariance matrix.|||0.95|-4.59|0.1964
71081192|NCT01763827|141669150|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.55|STANDARD_ERROR_OF_MEAN|1.88|<|0.001|TWO_SIDED|95.0|-41.24|-33.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-33.86|-41.24|<0.001
71120332|NCT00909545|141746223|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1364|STANDARD_ERROR_OF_MEAN|1.4444||0.7236|TWO_SIDED|95.0|0.067|19.264|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Hypotension.||19.2640|0.0670|0.7236
71120333|NCT00909545|141746223|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0833|STANDARD_ERROR_OF_MEAN|1.2576||0.5|TWO_SIDED|95.0|0.1771|24.5057|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Hypotension.||24.5057|0.1771|0.5000
71120334|NCT00909545|141746223|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2727|STANDARD_ERROR_OF_MEAN|1.2592||0.4694|TWO_SIDED|95.0|0.1926|26.8124|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Hypotension.||26.8124|0.1926|0.4694
71120335|NCT00884039|141746344|SUPERIORITY_OR_OTHER|||||||0.57|||||||Fisher Exact|||||||0.57
71120336|NCT00072293|141746345|NON_INFERIORITY_OR_EQUIVALENCE|As originally designed, target accrual was 1960 patients with analysis planned after 558 events. These targets were based on having 90% power to detect non-inferiority of no axillary dissection with a one-sided statistical signifi cance level of 10% (ie, α=0·10) under the assumption that 5-year disease-free survival with axillary dissection was 70% and defining non-inferiority as a hazard ratio (HR) of less than 1·25 (no axillary dissection relative to axillary dissection).|Hazard Ratio (HR)|0.78||||0.004|TWO_SIDED|95.0|0.55|1.11||Test for non-inferiority of no axillary dissection. Stratified logrank test compared groups. HR (no-AD vs AD) estimated from test statistic and variance as HR=exp(\[O-E\]/V), compared to 1.25 in 1-sided test of non-inferiority.|1-sided non-inferiority test||Hazard Ratio is no axillary dissection/axillary dissection.|||1.11|0.55|0.004
71081193|NCT01763827|141669151|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.5|STANDARD_ERROR_OF_MEAN|1.76|<|0.001|TWO_SIDED|95.0|-59.95|-53.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-53.04|-59.95|<0.001
71120337|NCT00072293|141746346|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.73|TWO_SIDED|90.0|0.52|1.54|||Log Rank||Hazard Ratio is no axillary dissection/axillary dissection.|||1.54|0.52|0.73
71120338|NCT00901511|141746359|SUPERIORITY||Median Difference (Final Values)|12.0||||0.0078|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the median time to rescue WLL in the GM-CSF Group minus the median the time to rescue WLL in the Control Group|||||0.0078
71120339|NCT00901511|141746360|SUPERIORITY||Risk Ratio (RR)|7.0||||0.0152|TWO_SIDED|95.0|1.6|39.9|||Fisher Exact||Calculated as risk ratio of rescue WLL in the Control Group compared to the risk ratio of rescue WLL in the GM-CSF Group|||39.9|1.60|0.0152
71120340|NCT00901511|141746361|SUPERIORITY||Mean Difference (Final Values)|9.5|||<|0.0001|TWO_SIDED|95.0|5.7|13.3|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the mean PaO2 in the GM-CSF Group minus the between group difference in mean PaO2 in the Control Group|||13.3|5.7|<0.0001
71120341|NCT00901511|141746361|SUPERIORITY||Mean Difference (Final Values)|15.1|STANDARD_ERROR_OF_MEAN|6.16||0.0261|TWO_SIDED|95.0|2.04|28.16|||t-test, 2 sided||Calculated as the difference at the pre-WLL visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the pre-WLL visit after imputation of missing data using a last observation carried forward method.||28.16|2.04|0.0261
71120342|NCT00901511|141746361|SUPERIORITY||Mean Difference (Final Values)|9.56|STANDARD_ERROR_OF_MEAN|6.36||0.1521|TWO_SIDED|95.0|3.92|23.03|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||23.03|3.92|0.1521
71120343|NCT00901511|141746361|SUPERIORITY||Mean Difference (Final Values)|18.04|STANDARD_ERROR_OF_MEAN|5.56||0.0051|TWO_SIDED|95.0|6.26|29.82|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||29.82|6.26|0.0051
71120344|NCT00901511|141746361|SUPERIORITY||Mean Difference (Final Values)|20.26|STANDARD_ERROR_OF_MEAN|4.54||0.0004|TWO_SIDED|95.0|10.63|29.88|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||29.88|10.63|0.0004
70943831|NCT03569475|141387806|SUPERIORITY||Least Square Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.6789|TWO_SIDED|95.0|-0.32|0.21|||Mixed Model for Repeated Measures||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and Baseline and Baseline-by-visit as covariates using an unstructured covariance matrix.|||0.21|-0.32|0.6789
70943832|NCT03569475|141387806|SUPERIORITY||Least Square Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1126|TWO_SIDED|95.0|-0.48|0.05|||Mixed Model for Repeated Measures|||||0.05|-0.48|0.1126
70943833|NCT03638258|141387807|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward (LOCF) where linear interpolation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||||||<0.001
71081194|NCT01763827|141669151|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.4|STANDARD_ERROR_OF_MEAN|1.66|<|0.001|TWO_SIDED|95.0|-60.66|-54.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-54.14|-60.66|<0.001
71081195|NCT01763827|141669151|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.41|STANDARD_ERROR_OF_MEAN|1.76|<|0.001|TWO_SIDED|95.0|-42.87|-35.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-35.94|-42.87|<0.001
71120345|NCT00901511|141746361|SUPERIORITY||Mean Difference (Final Values)|19.91|STANDARD_ERROR_OF_MEAN|5.89||0.0038|TWO_SIDED|95.0|7.43|32.4|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||32.40|7.43|0.0038
71120346|NCT00901511|141746361|SUPERIORITY||Mean Difference (Final Values)|16.92|STANDARD_ERROR_OF_MEAN|6.15||0.0149|TWO_SIDED|95.0|3.81|30.03|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||30.03|3.81|0.0149
71120347|NCT00901511|141746361|SUPERIORITY||Mean Difference (Final Values)|19.02|STANDARD_ERROR_OF_MEAN|6.97||0.0148|TWO_SIDED|95.0|4.26|33.79|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||33.79|4.26|0.0148
71120348|NCT00901511|141746361|SUPERIORITY||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|6.62||0.1158|TWO_SIDED|95.0|-3.02|25.02|||t-test, 2 sided|||The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.|Calculated as the difference at the 30-month visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|25.02|-3.02|0.1158
70855061|NCT02880956|141198373|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.079||0.688|TWO_SIDED|95.0|-0.188|0.124||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.124|-0.188|0.688
70943834|NCT03638258|141387807|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpolation was not computationally possible.||||||0.004|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||||||0.004
70943835|NCT03638258|141387808|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.015|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 4||||0.015
71120349|NCT00901511|141746362|SUPERIORITY||Mean Difference (Final Values)|-10.1|||<|0.0001|TWO_SIDED|95.0|-14.8|-5.4|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the mean value of A-aDO2 in the GM-CSF Group minus the mean value of A-aDO2 in the Control Group|Primary analysis||-5.4|-14.8|<0.0001
70943836|NCT03638258|141387808|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.174|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from placebo at Week 4||||0.174
70943837|NCT03638258|141387808|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 8||||<0.001
70954252|NCT00688870|141411077|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Redness - Mild, Fisher exact test was used to calculate p-value.||||>0.99
71120350|NCT00901511|141746362|SUPERIORITY||Mean Difference (Final Values)|-12.46|STANDARD_ERROR_OF_MEAN|6.0||0.0545|TWO_SIDED|95.0|-25.19|0.27|||t-test, 2 sided||Calculated as the difference at the pre-WLL visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the pre-WLL visit after imputation of missing data using a last observation carried forward method.||0.27|-25.19|0.0545
70943838|NCT03638258|141387808|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 8||||0.001
70943839|NCT03638258|141387808|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 12||||<0.001
70954253|NCT00688870|141411077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.275||95.0|||||Fisher Exact|||For Redness - Moderate, Fisher exact test was used to calculate p-value.||||0.275
71120351|NCT00901511|141746362|SUPERIORITY||Mean Difference (Final Values)|-7.08|STANDARD_ERROR_OF_MEAN|6.34||0.2802|TWO_SIDED|95.0|-20.52|6.35|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||6.35|-20.52|0.2802
71120352|NCT00901511|141746362|SUPERIORITY||Mean Difference (Final Values)|-16.81|STANDARD_ERROR_OF_MEAN|6.16||0.0148|TWO_SIDED|95.0|-29.85|-3.76|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||-3.76|-29.85|0.0148
71120353|NCT00901511|141746362|SUPERIORITY||Mean Difference (Final Values)|-18.77|STANDARD_ERROR_OF_MEAN|4.91||0.0015|TWO_SIDED|95.0|-29.18|-8.36|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the 3 -month visit after imputation of missing data using a last observation carried forward method.||-8.36|-29.18|0.0015
71120354|NCT00901511|141746362|SUPERIORITY||Mean Difference (Final Values)|-19.09|STANDARD_ERROR_OF_MEAN|5.85||0.0049|TWO_SIDED|95.0|-31.49|-6.7|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||-6.70|-31.49|0.0049
71120355|NCT00901511|141746362|SUPERIORITY||Mean Difference (Final Values)|-15.85|STANDARD_ERROR_OF_MEAN|5.84||0.0152|TWO_SIDED|95.0|-28.23|-3.48|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||-3.48|-28.23|0.0152
71120356|NCT00901511|141746362|SUPERIORITY||Mean Difference (Final Values)|-17.01|STANDARD_ERROR_OF_MEAN|6.27||0.0154|TWO_SIDED|95.0|-30.31|-3.71|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||-3.71|-30.31|0.0154
71120357|NCT00901511|141746362|SUPERIORITY||Mean Difference (Final Values)|-11.01|STANDARD_ERROR_OF_MEAN|6.15||0.0921|TWO_SIDED|95.0|-24.05|2.02|||t-test, 2 sided||Calculated as the difference at the 30-month visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||2.02|-24.05|0.0921
71120358|NCT00901511|141746363|SUPERIORITY||Mean Difference (Final Values)|11.6||||0.022|TWO_SIDED|95.0|1.9|21.3|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the mean value of the DLCO in the GM-CSF Group minus the mean value of the DLCO in the Control Group|Primary Analysis||21.3|1.9|0.0220
71120359|NCT00901511|141746363|SUPERIORITY||Mean Difference (Final Values)|8.29|STANDARD_ERROR_OF_MEAN|7.96||0.3186|TWO_SIDED|95.0|-9.06|25.63|||t-test, 2 sided||Calculated as the difference at the Pre-WLL visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||25.63|-9.06|0.3186
71120360|NCT00901511|141746363|SUPERIORITY||Mean Difference (Final Values)|5.56|STANDARD_ERROR_OF_MEAN|6.58||0.4111|TWO_SIDED|95.0|-8.4|19.51|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||19.51|-8.40|0.4111
70943840|NCT03638258|141387808|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.008|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 12||||0.008
71120361|NCT00901511|141746363|SUPERIORITY||Mean Difference (Final Values)|12.89|STANDARD_ERROR_OF_MEAN|6.53||0.0658|TWO_SIDED|95.0|-0.95|26.73|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||26.73|-0.95|0.0658
71120362|NCT00901511|141746363|SUPERIORITY||Mean Difference (Final Values)|9.78|STANDARD_ERROR_OF_MEAN|7.81||0.2287|TWO_SIDED|95.0|-6.78|26.34|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||26.34|-6.78|0.2287
71120363|NCT00901511|141746363|SUPERIORITY||Mean Difference (Final Values)|12.86|STANDARD_ERROR_OF_MEAN|8.37||0.1432|TWO_SIDED|95.0|-4.86|30.64|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||30.64|-4.86|0.1432
71120364|NCT00901511|141746363|SUPERIORITY||Mean Difference (Final Values)|11.78|STANDARD_ERROR_OF_MEAN|8.47||0.1833|TWO_SIDED|95.0|-6.17|29.73|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||29.73|-6.17|0.1833
71120365|NCT00901511|141746363|SUPERIORITY||Mean Difference (Final Values)|12.67|STANDARD_ERROR_OF_MEAN|9.23||0.1888|TWO_SIDED|95.0|-6.9|32.23|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||32.23|-6.90|0.1888
71120366|NCT00901511|141746363|SUPERIORITY||Mean Difference (Final Values)|4.22|STANDARD_ERROR_OF_MEAN|8.79||0.6374|TWO_SIDED|95.0|-14.41|22.85|||t-test, 2 sided||Calculated as the difference at the 30-month visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||22.85|-14.41|0.6374
71120367|NCT00901511|141746364|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.532|TWO_SIDED|95.0|-5.3|9.9|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the mean value of VC in the GM-CSF Group minus the mean value of VC in the Control Group|Primary Analysis||9.90|-5.30|0.5320
71120368|NCT00901511|141746364|SUPERIORITY||Mean Difference (Final Values)|3.21|STANDARD_ERROR_OF_MEAN|7.55||0.6772|TWO_SIDED|95.0|-13.09|19.52|||t-test, 2 sided||Calculated as the difference at the Pre-WLL visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||19.52|-13.09|0.6772
70954254|NCT00688870|141411078|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Tenderness - Any, Fisher exact test was used to calculate p-value.||||>0.99
71120369|NCT00901511|141746364|SUPERIORITY||Mean Difference (Final Values)|1.44|STANDARD_ERROR_OF_MEAN|6.7||0.832|TWO_SIDED|95.0|-12.52|15.64|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||15.64|-12.52|0.8320
71120370|NCT00901511|141746364|SUPERIORITY||Mean Difference (Final Values)|1.47|STANDARD_ERROR_OF_MEAN|7.82||0.8532|TWO_SIDED|95.0|-15.19|18.14|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||18.14|-15.19|0.8532
70943841|NCT03638258|141387809|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 4||||<0.001
71120371|NCT00901511|141746364|SUPERIORITY||Mean Difference (Final Values)|2.22|STANDARD_ERROR_OF_MEAN|7.66||0.7752|TWO_SIDED|95.0|-14.0|18.44|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||18.44|-14.00|0.7752
71120372|NCT00901511|141746364|SUPERIORITY||Mean Difference (Final Values)|5.74|STANDARD_ERROR_OF_MEAN|8.65||0.5174|TWO_SIDED|95.0|-12.7|24.18|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean value of VC in the GM-CSF Group minus the mean value of VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||24.18|-12.70|0.5174
71120373|NCT00901511|141746364|SUPERIORITY||Mean Difference (Final Values)|3.67|STANDARD_ERROR_OF_MEAN|7.68||0.6393|TWO_SIDED|95.0|-12.61|19.94|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||19.94|-12.61|0.6393
71120374|NCT00901511|141746364|SUPERIORITY||Mean Difference (Final Values)|5.22|STANDARD_ERROR_OF_MEAN|8.26||0.5361|TWO_SIDED|95.0|-12.28|22.73|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||22.73|-12.28|0.5361
71120375|NCT00901511|141746364|SUPERIORITY||Mean Difference (Final Values)|1.67|STANDARD_ERROR_OF_MEAN|7.04||0.8159|TWO_SIDED|95.0|-13.26|16.6|||t-test, 2 sided|||The secondary analysis includes evaluation of the difference in mean VC between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.|Calculated as the difference at the 30-month visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|16.60|-13.26|0.8159
71120376|NCT00901511|141746365|SUPERIORITY||Mean Difference (Final Values)|-0.822||||0.053|TWO_SIDED|95.0|-1.7|0.01|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the median value of the GGO Score in the GM-CSF Group minus the median value of the GGO Score in the Control Group|Primary Analysis||0.01|-1.70|0.0530
71120377|NCT00901511|141746365|SUPERIORITY||Median Difference (Final Values)|0.0|||>|0.9999|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the Pre-WLL visit in the median GGO Score in the GM-CSF Group minus the median GGO Score in the Control Group|The secondary analysis includes evaluation of the difference in median GGO Score between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||||>0.9999
71120378|NCT00901511|141746365|SUPERIORITY||Median Difference (Final Values)|-1.0||||0.0332|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 3-month visit in the median GGO Score in the GM-CSF Group minus the median GGO Score in the Control Group|The secondary analysis includes evaluation of the difference in median GGO Score between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||||0.0332
71120379|NCT00901511|141746365|SUPERIORITY||Median Difference (Final Values)|-1.0||||0.0676|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 10-month visit in the median GGO Score in the GM-CSF Group minus the median GGO Score in the Control Group|The secondary analysis includes evaluation of the difference in median GGO Score between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||||0.0676
71120380|NCT00901511|141746365|SUPERIORITY||Median Difference (Final Values)|-1.0||||0.0629|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 18-month visit in the median GGO Score in the GM-CSF Group minus the median GGO Score in the Control Group|The secondary analysis includes evaluation of the difference in median GGO Score between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||||0.0629
71120381|NCT00901511|141746365|SUPERIORITY||Median Difference (Final Values)|0.0|||>|0.9999|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 30-month visit in the median GGO Score in the GM-CSF Group minus the median GGO Score in the Control Group|The secondary analysis includes evaluation of the difference in median GGO Score between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||||>0.9999
71120382|NCT00901511|141746366|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.001|TWO_SIDED|95.0|-0.71|-0.22|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the CEA levels in the GM-CSF Group minus the CEA levels in the Control Group|Primary Analysis||-0.22|-0.71|0.0010
71120383|NCT00901511|141746366|SUPERIORITY||Median Difference (Final Values)|-12.0||||0.0059|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the Pre-WLL visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||||0.0059
71120384|NCT00901511|141746366|SUPERIORITY||Median Difference (Final Values)|-3.45||||0.0382|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the baseline visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||||0.0382
70943842|NCT03638258|141387809|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 4||||<0.001
70943843|NCT03638258|141387809|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 6||||<0.001
70943844|NCT03638258|141387809|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 6||||<0.001
70943845|NCT03638258|141387809|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.x|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 8||||<0.001
70943846|NCT03638258|141387809|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 8||||<0.001
70943847|NCT03638258|141387809|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 12||||<0.001
70943848|NCT03638258|141387809|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 12||||<0.001
70943849|NCT03638258|141387810|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle cream on Week 4||||<0.001
71081196|NCT01763827|141669151|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.69|STANDARD_ERROR_OF_MEAN|1.66|<|0.001|TWO_SIDED|95.0|-42.97|-36.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-36.42|-42.97|<0.001
70943850|NCT03638258|141387810|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle cream at Week 4||||<0.001
70943851|NCT03638258|141387810|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle cream at Week 6||||<0.001
70943852|NCT03638258|141387810|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle cream at Week 6||||<0.001
70943853|NCT03638258|141387810|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle at Week 8||||<0.001
70943854|NCT03638258|141387810|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle cream at Week 8||||<0.001
70943855|NCT03638258|141387810|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle at Week 12||||<0.001
70943856|NCT03638258|141387810|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle cream at Week 12||||<0.001
71120385|NCT00901511|141746366|SUPERIORITY||Median Difference (Final Values)|-3.2||||0.077|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 1-month visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||||0.0770
71120386|NCT00901511|141746366|SUPERIORITY||Median Difference (Final Values)|-4.0||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 3-month visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||||0.0400
71120387|NCT00901511|141746366|SUPERIORITY||Median Difference (Final Values)|-7.9||||0.0142|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 6-month visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||||0.0142
71120388|NCT00901511|141746366|SUPERIORITY||Median Difference (Final Values)|-6.5||||0.0071|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 10-month visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||||0.0071
71120389|NCT00901511|141746366|SUPERIORITY||Median Difference (Final Values)|-5.6||||0.0137|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 18-month visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||||0.0137
71120390|NCT00901511|141746366|SUPERIORITY||Median Difference (Final Values)|-3.2||||0.0315|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 30-month visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||||0.0315
71120391|NCT00901511|141746367|SUPERIORITY||Mean Difference (Final Values)|-3689.0||||0.03|TWO_SIDED|95.0|-6972.0|-406.0|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the KL-6 levels in the GM-CSF Group minus the KL-6 levels in the Control Group|Primary Analysis||-406|-6972|0.0300
71120392|NCT00901511|141746367|SUPERIORITY||Median Difference (Final Values)|-3265.0||||0.077|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the Pre-WLL visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||||0.0770
71120393|NCT00901511|141746367|SUPERIORITY||Median Difference (Final Values)|-5018.0||||0.0745|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the baseline visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||||0.0745
71120394|NCT00901511|141746367|SUPERIORITY||Median Difference (Final Values)|-6343.0||||0.2581|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 1-month visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||||0.2581
71120395|NCT00901511|141746367|SUPERIORITY||Median Difference (Final Values)|-4102.0||||0.4894|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 3-month visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||||0.4894
71120396|NCT00901511|141746367|SUPERIORITY||Median Difference (Final Values)|-6818.0|||>|0.9999|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 6-month visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||||>0.9999
71120397|NCT00901511|141746367|SUPERIORITY||Median Difference (Final Values)|-1570.0||||0.8633|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 10-month visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||||0.8633
71120398|NCT00901511|141746367|SUPERIORITY||Median Difference (Final Values)|-4200.0||||0.3401|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 18-month visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||||0.3401
70943857|NCT03638258|141387811|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.116|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 4||||0.116
70943858|NCT03638258|141387811|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.423|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 4||||0.423
70943859|NCT03638258|141387811|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.002|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 6||||0.002
70943860|NCT03638258|141387811|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.038|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 6||||0.038
70943861|NCT03638258|141387811|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 8||||<0.001
71081197|NCT01763827|141669152|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-79.6|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-85.0|-74.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-74.2|-85.0|<0.001
71081198|NCT01763827|141669152|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-81.9|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-87.0|-76.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-76.9|-87.0|<0.001
71120399|NCT00901511|141746367|SUPERIORITY||Median Difference (Final Values)|-4307.0||||0.2973|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 30-month visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||||0.2973
71120400|NCT00901511|141746368|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.22|TWO_SIDED|95.0|-0.44|-0.04|||Repeated measures ANOVA||Calculated as the between group difference in the serum Cyfra21.1 levels in the GM-CSF Group minus the serum Cyfra21.1 levels in the Control Group|Primary Analysis||-0.04|-0.44|0.220
71120401|NCT00901511|141746368|SUPERIORITY||Mean Difference (Final Values)|-14.19|STANDARD_ERROR_OF_MEAN|6.76||0.056|TWO_SIDED|95.0|-28.8|0.42|||t-test, 2 sided||Calculated as the difference at the Pre-WLL visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|•The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||0.42|-28.80|0.0560
71120402|NCT00901511|141746368|SUPERIORITY||Mean Difference (Final Values)|-4.26|STANDARD_ERROR_OF_MEAN|2.15||0.0648|TWO_SIDED|95.0|-8.8|0.29|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||0.29|-8.80|0.0648
71120403|NCT00901511|141746368|SUPERIORITY||Mean Difference (Final Values)|-6.27|STANDARD_ERROR_OF_MEAN|2.36||0.0175|TWO_SIDED|95.0|-11.28|-1.25|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||-1.25|-11.28|0.0175
71120404|NCT00901511|141746368|SUPERIORITY||Mean Difference (Final Values)|-16.81|STANDARD_ERROR_OF_MEAN|6.16||0.0148|TWO_SIDED|95.0|-29.85|-3.76|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||-3.76|-29.85|0.0148
71120405|NCT00901511|141746368|SUPERIORITY||Mean Difference (Final Values)|-5.41|STANDARD_ERROR_OF_MEAN|1.82||0.0089|TWO_SIDED|95.0|-9.27|-1.56|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||-1.56|-9.27|0.0089
71120406|NCT00901511|141746368|SUPERIORITY||Mean Difference (Final Values)|-5.18|STANDARD_ERROR_OF_MEAN|2.24||0.0343|TWO_SIDED|95.0|-9.92|-0.43|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||-0.43|-9.92|0.0343
71120407|NCT00901511|141746368|SUPERIORITY||Mean Difference (Final Values)|-4.26|STANDARD_ERROR_OF_MEAN|2.33||0.0871|TWO_SIDED|95.0|-9.21|0.69|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||0.69|-9.21|0.0871
70943862|NCT03638258|141387811|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.005|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 8||||0.005
70954255|NCT00688870|141411078|SUPERIORITY_OR_OTHER_LEGACY|||||||0.617||95.0|||||Fisher Exact|||For Tenderness - Significant, Fisher exact test was used to calculate p-value.||||0.617
70855062|NCT02880956|141198373|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|0.64|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70943863|NCT03638258|141387811|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.002|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 12||||0.002
70943864|NCT03638258|141387811|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.013|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 12||||0.013
70855063|NCT02880956|141198373|SUPERIORITY||LS Mean of Difference|0.12|STANDARD_ERROR_OF_MEAN|0.081||0.137|TWO_SIDED|95.0|-0.039|0.281||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.281|-0.039|0.137
70943865|NCT03638258|141387812|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.086|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference form vehicle cream at Week 4||||0.086
70943866|NCT03638258|141387812|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.123|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle cream at Week 4||||0.123
70943867|NCT03638258|141387812|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.017|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle cream at Week 6||||0.017
70943868|NCT03638258|141387812|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.415|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle cream at Week 6||||0.415
71120408|NCT00901511|141746368|SUPERIORITY||Mean Difference (Final Values)|-3.01|STANDARD_ERROR_OF_MEAN|2.4||0.2265|TWO_SIDED|95.0|-8.09|2.06|||t-test, 2 sided||Calculated as the difference at the 30-month visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||2.06|-8.09|0.2265
71120409|NCT00901511|141746369|SUPERIORITY||Median Difference (Final Values)|8.78||||0.3865|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the Pre-WLL visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||||0.3865
71120410|NCT00901511|141746369|SUPERIORITY||Median Difference (Final Values)|7.82||||0.1672|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the baseline visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||||0.1672
71120411|NCT00901511|141746369|SUPERIORITY||Median Difference (Final Values)|4.24||||0.4363|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 1-month visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||||0.4363
71120412|NCT00901511|141746369|SUPERIORITY||Median Difference (Final Values)|7.34||||0.1615|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 3-month visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||||0.1615
71120413|NCT00901511|141746369|SUPERIORITY||Median Difference (Final Values)|13.71||||0.1615|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 6-month visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||||0.1615
71120414|NCT00901511|141746369|SUPERIORITY||Median Difference (Final Values)|11.1||||0.3865|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 10-month visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||||0.3865
71120415|NCT00901511|141746369|SUPERIORITY||Median Difference (Final Values)|5.4||||0.6475|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||• Calculated as the difference at the 18-month visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||||0.6475
71120416|NCT00901511|141746369|SUPERIORITY||Median Difference (Final Values)|-7.0||||0.6481|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 30-month visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||||0.6481
71120417|NCT00901511|141746370|SUPERIORITY||Mean Difference (Final Values)|-1.55|STANDARD_ERROR_OF_MEAN|0.78||0.0582|TWO_SIDED|95.0|-3.17|0.06|||t-test, 2 sided||Calculated as the difference at the Pre-WLL visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||0.06|-3.17|0.0582
71120418|NCT00901511|141746370|SUPERIORITY||Mean Difference (Final Values)|1.15|STANDARD_ERROR_OF_MEAN|1.09||0.3068|TWO_SIDED|95.0|-1.17|3.48|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||3.48|-1.17|0.3068
70943869|NCT03638258|141387812|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.007|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle cream at Week 8||||0.007
70943870|NCT03638258|141387812|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.175|||||||Regression, Linear|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle cream at Week 8||||0.175
70954256|NCT00688870|141411078|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81||95.0|||||Fisher Exact|||For Swelling - Any, Fisher exact test was used to calculate p-value.||||0.810
70855064|NCT02880956|141198373|SUPERIORITY||Effect size/pooled SD|-0.18|STANDARD_DEVIATION|0.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70954257|NCT00688870|141411078|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81||95.0|||||Fisher Exact|||For Swelling - Mild, Fisher exact test was used to calculate p-value.||||0.810
71120419|NCT00901511|141746370|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.75||0.5647|TWO_SIDED|95.0|-2.04|1.15|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||1.15|-2.04|0.5647
71120420|NCT00901511|141746370|SUPERIORITY||Mean Difference (Final Values)|-0.86|STANDARD_ERROR_OF_MEAN|0.59||0.1669|TWO_SIDED|95.0|-2.11|0.4|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||0.40|-2.11|0.1669
71120421|NCT00901511|141746370|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_DEVIATION|0.69||0.453|TWO_SIDED|95.0|-1.99|0.93|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||0.93|-1.99|0.4530
71120422|NCT00901511|141746370|SUPERIORITY||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.71||0.4594|TWO_SIDED|95.0|-2.04|0.97|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||0.97|-2.04|0.4594
71120423|NCT00901511|141746370|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.62||0.6302|TWO_SIDED|95.0|-1.61|1.0|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||1.00|-1.61|0.6302
71120424|NCT00901511|141746370|SUPERIORITY||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.72||0.33|TWO_SIDED|95.0|-2.24|0.8|||t-test, 2 sided||Calculated as the difference at the 30-month visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||0.80|-2.24|0.3300
71120425|NCT00901511|141746371|SUPERIORITY||Mean Difference (Final Values)|-53.72|STANDARD_ERROR_OF_MEAN|38.79||0.1864|TWO_SIDED|95.0|-136.4|28.96|||t-test, 2 sided||Calculated as the difference at the Pre-WLL visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||28.96|-136.4|0.1864
71120426|NCT00901511|141746371|SUPERIORITY||Mean Difference (Final Values)|-21.17|STANDARD_ERROR_OF_MEAN|46.3||0.6541|TWO_SIDED|95.0|-119.8|77.51|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||77.51|-119.8|0.6541
71120427|NCT00901511|141746371|SUPERIORITY||Mean Difference (Final Values)|-18.78|STANDARD_ERROR_OF_MEAN|24.58||0.456|TWO_SIDED|95.0|-70.89|33.33|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||33.33|-70.89|0.4560
71120428|NCT00901511|141746371|SUPERIORITY||Mean Difference (Final Values)|-28.44|STANDARD_ERROR_OF_MEAN|30.98||0.3721|TWO_SIDED|95.0|-94.12|37.23|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||37.23|-94.12|0.3721
71120429|NCT00901511|141746371|SUPERIORITY||Mean Difference (Final Values)|-28.78|STANDARD_ERROR_OF_MEAN|20.58||0.1812|TWO_SIDED|95.0|-72.41|14.86|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||14.86|-72.41|0.1812
71120430|NCT00901511|141746371|SUPERIORITY||Mean Difference (Final Values)|-26.11|STANDARD_ERROR_OF_MEAN|23.38||0.2805|TWO_SIDED|95.0|-75.67|23.44|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||23.44|-75.67|0.2805
71120431|NCT00901511|141746371|SUPERIORITY||Mean Difference (Final Values)|-27.33|STANDARD_ERROR_OF_MEAN|22.75||0.247|TWO_SIDED|95.0|-75.56|20.89|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||20.89|-75.56|0.2470
70943871|NCT03638258|141387812|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle at Week 12||||0.001
70943872|NCT03638258|141387812|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.619|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle cream at Week 12||||0.619
70943873|NCT03638258|141387813|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 4||||<0.001
70943874|NCT03638258|141387813|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.002|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 4||||0.002
70943875|NCT03638258|141387813|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 6||||<0.001
71081199|NCT01763827|141669152|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.3|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-60.7|-49.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-49.9|-60.7|<0.001
71081200|NCT01763827|141669152|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.1|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-61.1|-51.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-51.0|-61.1|<0.001
71081201|NCT01763827|141669153|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-80.4|STANDARD_ERROR_OF_MEAN|3.1|<|0.001|TWO_SIDED|95.0|-86.4|-74.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-74.3|-86.4|<0.001
71081202|NCT01763827|141669153|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-77.8|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-83.4|-72.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-72.2|-83.4|<0.001
71081203|NCT01763827|141669153|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.0|STANDARD_ERROR_OF_MEAN|3.1|<|0.001|TWO_SIDED|95.0|-61.1|-49.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe was the reference|||-49.0|-61.1|<0.001
70855065|NCT02880956|141198373|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.107||0.408|TWO_SIDED|95.0|-0.3|0.122||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.122|-0.300|0.408
70943876|NCT03638258|141387813|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 6||||<0.001
70943877|NCT03638258|141387813|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 8||||<0.001
70943878|NCT03638258|141387813|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 8||||<0.001
71081204|NCT01763827|141669153|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.9|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|-58.5|-47.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe was the reference|||-47.3|-58.5|<0.001
71081205|NCT01763827|141669154|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|73.6|||<|0.001|TWO_SIDED|95.0|64.4|80.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||80.2|64.4|<0.001
71081206|NCT01763827|141669154|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|71.3|||<|0.001|TWO_SIDED|95.0|62.2|78.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||78.0|62.2|<0.001
71081207|NCT01763827|141669154|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|72.2|||<|0.001|TWO_SIDED|95.0|62.4|78.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||78.9|62.4|<0.001
70855066|NCT02880956|141198373|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|0.89|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70943879|NCT03638258|141387813|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 12||||<0.001
70943880|NCT03638258|141387813|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 12||||<0.001
70943881|NCT03638258|141387814|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.002|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 4||||0.002
70943882|NCT03638258|141387814|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.203|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 4||||0.203
70943883|NCT03638258|141387814|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.034|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 6||||0.034
71120432|NCT00901511|141746371|SUPERIORITY||Mean Difference (Final Values)|-31.0|STANDARD_ERROR_OF_MEAN|23.57||0.207|TWO_SIDED|95.0|-80.97|18.97|||t-test, 2 sided||Calculated as the difference at the 30-month visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||18.97|-80.97|0.2070
71120433|NCT00901511|141746372|SUPERIORITY||Mean Difference (Final Values)|4.72||||0.149|TWO_SIDED|95.0|-1.88|11.33|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the difference in the mean value of the SF-36 General Health Score in the GM-CSF Group minus the Control Group|Primary analysis||11.33|-1.88|0.1490
71120434|NCT00901511|141746372|SUPERIORITY||Mean Difference (Final Values)|-4.31|STANDARD_ERROR_OF_MEAN|12.07||0.7263|TWO_SIDED|95.0|-30.04|21.43|||t-test, 2 sided||Calculated as the difference at the Pre-WLL visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in mean SF-36 General Health Score between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||21.43|-30.04|0.7263
71120435|NCT00901511|141746372|SUPERIORITY||Mean Difference (Final Values)|8.33|STANDARD_ERROR_OF_MEAN|8.29||0.3298|TWO_SIDED|95.0|-9.24|25.91|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in SF-36 General Health Score between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||25.91|-9.24|0.3298
71120436|NCT00901511|141746372|SUPERIORITY||Mean Difference (Final Values)|13.89|STANDARD_ERROR_OF_MEAN|6.48||0.0478|TWO_SIDED|95.0|-0.15|27.62|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in SF-36 General Health Score between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||27.62|-0.15|0.0478
71120437|NCT00901511|141746372|SUPERIORITY||Mean Difference (Final Values)|17.78|STANDARD_ERROR_OF_MEAN|7.37||0.0281|TWO_SIDED|95.0|2.16|33.39|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in mean SF-36 General Health Score between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||33.39|2.16|0.0281
71120438|NCT00901511|141746372|SUPERIORITY||Mean Difference (Final Values)|11.67|STANDARD_ERROR_OF_MEAN|10.07||0.2634|TWO_SIDED|95.0|-9.67|33.0|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in mean SF-36 General Health Score between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||33.00|-9.67|0.2634
71120439|NCT00901511|141746372|SUPERIORITY||Mean Difference (Final Values)|10.0|STANDARD_ERROR_OF_MEAN|10.49||0.3548|TWO_SIDED|95.0|-12.24|32.24|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in mean SF-36 General Health Score between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||32.24|-12.24|0.3548
71120440|NCT00901511|141746372|SUPERIORITY||Mean Difference (Final Values)|16.67|STANDARD_ERROR_OF_MEAN|9.68||0.1043|TWO_SIDED|95.0|-3.85|37.18|||t-test, 2 sided||Calculated as the difference at the 30-month visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in mean SF-36 General Health Score between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||37.18|-3.85|0.1043
71120441|NCT02880514|141746419|SUPERIORITY|||||||0.0391||||||P-value not adjusted for multiplicity.|McNemar|McNemar's exact binomial test was employed to obtain the two-sided p-value at alpha level of 0.05.||||||0.0391
71120442|NCT02880514|141746420|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||0.68
70943884|NCT03638258|141387814|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.012|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 6||||0.012
70943885|NCT03638258|141387814|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.01|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 8||||0.010
70943886|NCT03638258|141387814|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.075|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 8||||0.075
70943887|NCT03638258|141387814|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 12||||<0.001
70943888|NCT03638258|141387814|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 12||||<0.001
70943889|NCT03638258|141387815|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.527|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 4||||0.527
70943890|NCT03638258|141387815|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.444|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 4||||0.444
71120443|NCT02436668|141746421|SUPERIORITY||Hazard Ratio (HR)|1.525|||<|0.0001|TWO_SIDED|95.0|1.241|1.873||P-value is from log-rank test stratified by the three randomization stratification factors \[KPS (70-80 vs. 90-100), liver metastasis (present vs. absent), and age (≤65 vs. \>65)\].|Log Rank|||The treatment effect was tested with an stratified log rank test. Hazard ratio is estimated using Cox regression model stratified by the three randomization stratification factors \[KPS (70 80 vs. 90-100), liver metastasis (present vs. absent), and age (≤65 vs. \>65)\] and with treatment as the only covariate.||1.873|1.241|<0.0001
71120444|NCT02436668|141746422|SUPERIORITY|P-value is based on log-rank test stratified by the three randomization stratification factors \[KPS (70-80 vs. 90-100), liver metastasis (present vs. absent), and age (≤65 vs. \>65)\].|Hazard Ratio (HR)|1.109||||0.3225|TWO_SIDED|95.0|0.903|1.363|||Log Rank|||The treatment effect was tested with an stratified log rank test. Hazard ratio is estimated using Cox regression model stratified by the three randomization stratification factors \[KPS (70 80 vs. 90-100), liver metastasis (present vs. absent), and age (≤65 vs. \>65)\] and with treatment as the only covariate.||1.363|0.903|0.3225
71120445|NCT02436668|141746424|SUPERIORITY||Risk Ratio (RR)|0.695||||0.0058|TWO_SIDED|95.0|0.535|0.903|||Cochran-Mantel-Haenszel|||For rate ratio, numerator is Ibr+Gem/Abr arm and denominator is Pbo + Gem/Abr arm. P-value for rate ratio is based on Cochran-Mantel-Haenszel (CMH) test adjusted for the three randomization stratification factors. Two-sided 95% confidence interval for rate ratio is based on Mantel-Haenszel method.||0.903|0.535|0.0058
71120446|NCT02436668|141746426|SUPERIORITY||Risk Ratio (RR)|0.85||||0.0488|TWO_SIDED|95.0|0.722|1.0|||Cochran-Mantel-Haenszel||This 0.85 (0.722 to 1.0) with CI is referring to risk ratio not proportional/percentage of patients.|For rate ratio, numerator is Ibr+Gem/Abr arm and denominator is Pbo+Gem/Abr arm. P-value for rate ratio is based on Cochran-Mantel-Haenszel (CMH) test adjusted for the three randomization stratification factors. Two-sided 95% confidence interval for rate ratio is based on Mantel-Haenszel method.||1.0|0.722|0.0488
71120447|NCT02436668|141746427|SUPERIORITY||Hazard Ratio (HR)|1.265||||0.0782|TWO_SIDED|95.0|0.975|1.642||P-value is from log-rank test stratified by the three randomization stratification factors.|Log Rank|||\[1\] Hazard ratio is based on a Cox proportional hazards model stratified by the three randomization stratification factors for time until definitive deterioration (TUDD1), a hazard ratio \< 1 favors Ibr + Gem/Abr. TUDD1 is defined as the time interval between randomization and the first occurrence of a decrease in score by \>= 10 points without any further improvement in score by \>= 10 points or any further available QoL data due to dropout after deterioration.||1.642|0.975|0.0782
70943891|NCT03638258|141387815|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.006|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 6||||0.006
70943892|NCT03638258|141387815|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.013|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 6||||0.013
70943893|NCT03638258|141387815|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.002|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 8||||0.002
70943894|NCT03638258|141387815|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.064|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 8||||0.064
70943895|NCT03638258|141387815|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.002|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 12||||0.002
71120448|NCT02436668|141746428|SUPERIORITY|||||||0.3343|||||||Chi-squared|||"For rate of VTEs, denominator is number of subjects in the Intent-to-Treat population and numerator is number of Intent-to-Treat subjects with at least one VTE observed any time on study. Confidence interval for rate of VTEs is based on Clopper-Pearson method.~\[1\] P value is based on Chi-square test."||||0.3343
71120449|NCT02210221|141746434|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No corrections for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum in 6-month mortality||||<0.0001
71120450|NCT02210221|141746434|OTHER||observed to expected ratio|0.7|||||TWO_SIDED|95.0|0.62|0.76|||||numerator: 6-month mortality observed denominator: 6-month mortality expected 95% CIs estimated according to a Poisson distribution|||0.76|0.62|
71120451|NCT02210221|141746435|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No corrections for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum in SF-12v2 mental component summary||||<0.0001
71120452|NCT02210221|141746435|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No corrections for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum in SF-12v2 physical component summary||||<0.0001
71120453|NCT02210221|141746436|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No corrections for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum in Qolibri Overall Scale||||<0.0001
71120454|NCT02210221|141746437|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No correlations for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
71120455|NCT02210221|141746438|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No correlations for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
71120456|NCT02210221|141746439|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No correlations for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
70943896|NCT03638258|141387815|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.009|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 12||||0.009
71120457|NCT02210221|141746440|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
71120458|NCT02210221|141746441|NON_INFERIORITY|non-inferiority margin = 0||||||0.169|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||0.169
71120459|NCT02210221|141746442|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||Fisher Exact|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
71120460|NCT02210221|141746443|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
71120461|NCT02210221|141746444|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
70943897|NCT03638258|141387816|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.188|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 4||||0.188
70943898|NCT03638258|141387816|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.577|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 4||||0.577
70943899|NCT03638258|141387816|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.008|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 6||||0.008
70943900|NCT03638258|141387816|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.664|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 6||||0.664
70943901|NCT03638258|141387816|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.015|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 8||||0.015
70943902|NCT03638258|141387816|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.666|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 8||||0.666
70943903|NCT03638258|141387816|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.009|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 12||||0.009
70943904|NCT03638258|141387816|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.163|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 12||||0.163
70943905|NCT03638258|141387817|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible. ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||||||0.002|||||||ANOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from vehicle cream on Week 4||||0.002
70943906|NCT03638258|141387817|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.002|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from vehicle cream at Week 4||||0.002
70943907|NCT03638258|141387817|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from vehicle cream at Week 6||||<0.001
70943908|NCT03638258|141387817|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from placebo at Week 6||||<0.001
71120462|NCT02210221|141746445|NON_INFERIORITY|non-inferiority margin = 0||||||0.637|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||0.637
70943909|NCT03638258|141387817|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from placebo at Week 8||||<0.001
70943910|NCT03638258|141387817|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from vehicle cream at Week 8||||<0.001
71120463|NCT02210221|141746446|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
70943911|NCT03638258|141387817|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from vehicle cream at Week 12||||<0.001
70943912|NCT03638258|141387817|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from vehicle cream at Week 12||||<0.001
70943913|NCT03638258|141387818|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.184|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss score.||Difference from vehicle cream at Week 4||||0.184
70943914|NCT03638258|141387818|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.207|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||Difference from placebo at Week 4||||0.207
70943915|NCT03638258|141387818|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.004|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||Difference from vehicle cream at Week 6||||0.004
70943916|NCT03638258|141387818|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.022|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||Difference from vehicle cream at Week 6||||0.022
70943917|NCT03638258|141387818|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.003|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||Difference from vehicle cream at Week 8||||0.003
70855067|NCT02880956|141198373|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.104||0.249|TWO_SIDED|95.0|-0.325|0.085||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.085|-0.325|0.249
70855068|NCT02880956|141198373|SUPERIORITY||Effect size/pooled SD|0.15|STANDARD_DEVIATION|0.79|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70943918|NCT03638258|141387818|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||Difference from vehicle cream at Week 8||||<0.001
70943919|NCT03638258|141387818|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible. ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||||||0.003|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||Difference from vehicle cream at Week 12||||0.003
71081208|NCT01763827|141669154|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|68.6|||<|0.001|TWO_SIDED|95.0|58.3|75.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||75.5|58.3|<0.001
71081209|NCT01763827|141669155|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|71.5|||<|0.001|TWO_SIDED|95.0|61.2|78.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||78.4|61.2|<0.001
71081210|NCT01763827|141669155|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|65.4|||<|0.001|TWO_SIDED|95.0|55.6|72.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||72.9|55.6|<0.001
70954258|NCT00688870|141411078|SUPERIORITY_OR_OTHER_LEGACY|||||||0.674||95.0|||||Fisher Exact|||For Redness - Any, Fisher exact test was used to calculate p-value.||||0.674
71081211|NCT01763827|141669155|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|71.5|||<|0.001|TWO_SIDED|95.0|61.3|78.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||78.4|61.3|<0.001
71081212|NCT01763827|141669155|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|64.0|||<|0.001|TWO_SIDED|95.0|53.5|71.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||71.6|53.5|<0.001
71120464|NCT02210221|141746447|NON_INFERIORITY|non-inferiority margin = 0||||||0.48|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||0.480
71120465|NCT02210221|141746448|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
71120466|NCT02210221|141746449|NON_INFERIORITY|non-inferiority margin = 0||||||0.024|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||0.024
71120467|NCT02210221|141746450|NON_INFERIORITY|non-inferiority margin = 0||||||0.064|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||0.064
71120468|NCT02210221|141746451|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
71120469|NCT00434759|141746456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.82|||<|0.05||95.0||||priori threshold for statistical significance is 0.05 p-value is not adjusted for multiple comparisons|ANOVA|We report the interaction effect.|The reported interaction effect is significant (p\< .05) in favour of standard therapy.|||||<0.05
71120470|NCT00434759|141746457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24|||<|0.05||95.0||||priori threshold for statistical significance is 0.05 p-value ist not adjusted for multiple comparisons|ANOVA|we report the interaction effect|The reported interaction effect is not significant.|||||<0.05
71120471|NCT00434759|141746458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99|||<|0.05||95.0||||p-value is not adjusted for multiple comparisons|ANOVA|we report the interaction effect|The reported interaction effect is not significant.|||||<0.05
71120472|NCT00434759|141746459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.43|||<|0.05||95.0||||priori threshold for statistical significance is 0.05 p-value ist not adjusted for multiple comparisons|ANOVA|we report the interaction effect|The reported interaction is not significant.|||||<0.05
71120473|NCT00434759|141746460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.86|||<|0.05||95.0||||priori threshold for statistical significance ist 0.05 p-value ist nor adjusted for multiple comparisons|ANOVA|we report the interaction effect|The reported interaction effect is significant (p \< .05) in favour of standard therapy|||||<0.05
71120474|NCT00997425|141746461|SUPERIORITY_OR_OTHER|||||||0.098|TWO_SIDED|||||values above 0.05 are considered statistically not significant in this study|paired t-test|statistical analysis applies to door approach behavior||||||0.098
71120475|NCT00997425|141746461|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED|||||P values above 0.05 are considered statistically not significant in this study|paired t-test|statistical analysis applies to door pass through behavior||||||0.045
71120476|NCT01300819|141746466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.58||||0.147|TWO_SIDED|95.0|-8.43|1.26||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysing was performed with ANCOVA model, adjusted for several terms.||Null hypothesis: mean change in the total Nonmotor Symptoms Scale (NMSS) score is the same for rotigotine- and placebo-treated group.||1.26|-8.43|0.147
71120477|NCT01300819|141746467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.002|TWO_SIDED|95.0|-4.27|-0.92||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||-0.92|-4.27|0.002
71120478|NCT01300819|141746468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.79||||0.024|TWO_SIDED|95.0|-5.21|-0.37||Two-sided p-values are presented.|ANCOVA|Testing was performed using an ANCOVA model, adjusted for several terms.||||-0.37|-5.21|0.024
71120479|NCT01300819|141746469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.773|TWO_SIDED|95.0|-0.67|0.5||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||0.50|-0.67|0.773
70855069|NCT02880956|141198373|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.107||0.616|TWO_SIDED|95.0|-0.265|0.157||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.157|-0.265|0.616
70855070|NCT02880956|141198373|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|0.95|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855071|NCT02880956|141198373|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.119||0.555|TWO_SIDED|95.0|-0.163|0.304||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.304|-0.163|0.555
70855072|NCT02880956|141198373|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|0.83|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855073|NCT02880956|141198373|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.117||0.815|TWO_SIDED|95.0|-0.203|0.258||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.258|-0.203|0.815
70855074|NCT02880956|141198373|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|0.82|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71081213|NCT01763827|141669156|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-48.81|STANDARD_ERROR_OF_MEAN|1.63|<|0.001|TWO_SIDED|95.0|-52.01|-45.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-45.61|-52.01|<0.001
70855075|NCT02880956|141198373|SUPERIORITY||LS Mean of Difference|0.18|STANDARD_ERROR_OF_MEAN|0.119||0.138|TWO_SIDED|95.0|-0.057|0.409||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.409|-0.057|0.138
70855076|NCT02880956|141198373|SUPERIORITY||Effect size/pooled SD|-0.2|STANDARD_DEVIATION|0.89|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855077|NCT02880956|141198373|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.157||0.573|TWO_SIDED|95.0|-0.397|0.22||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.220|-0.397|0.573
70855078|NCT02880956|141198373|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|1.0|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855079|NCT02880956|141198373|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.154||0.689|TWO_SIDED|95.0|-0.241|0.365||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.365|-0.241|0.689
70855080|NCT02880956|141198373|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855081|NCT02880956|141198373|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.159||0.662|TWO_SIDED|95.0|-0.243|0.382||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.382|-0.243|0.662
70855082|NCT02880956|141198373|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|1.14|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855083|NCT02880956|141198374|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.184||0.291|TWO_SIDED|95.0|-0.555|0.167||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.167|-0.555|0.291
70855084|NCT02880956|141198374|SUPERIORITY||Effect size/pooled SD|0.13|STANDARD_DEVIATION|1.48|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71120480|NCT01300819|141746470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.06||||0.122|TWO_SIDED|95.0|-2.41|0.29||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||0.29|-2.41|0.122
71120481|NCT01300819|141746471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.81||||0.047|TWO_SIDED|95.0|-3.59|-0.02||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||-0.02|-3.59|0.047
71120482|NCT01300819|141746472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.601|TWO_SIDED|95.0|-0.22|0.37||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||0.37|-0.22|0.601
71120483|NCT01300819|141746473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.997|TWO_SIDED|95.0|-0.99|0.99||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||0.99|-0.99|0.997
71120484|NCT01300819|141746474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.584|TWO_SIDED|95.0|-0.87|0.49||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||0.49|-0.87|0.584
70855085|NCT02880956|141198374|SUPERIORITY||Effect size/pooled SD|-0.36|STANDARD_ERROR_OF_MEAN|0.182||0.051|TWO_SIDED|95.0|-0.713|0.001||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.001|-0.713|0.051
71081214|NCT01763827|141669156|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-53.28|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-56.23|-50.33||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-50.33|-56.23|<0.001
70855086|NCT02880956|141198374|SUPERIORITY||Effect size/pooled SD|0.23|STANDARD_DEVIATION|1.52|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855087|NCT02880956|141198374|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.185||0.921|TWO_SIDED|95.0|-0.346|0.383||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.383|-0.346|0.921
70954259|NCT00688870|141411078|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Redness - Mild, Fisher exact test was used to calculate p-value.||||>0.99
71120485|NCT01300819|141746475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38||||0.536|TWO_SIDED|95.0|-0.84|1.6||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||1.60|-0.84|0.536
71120486|NCT01300819|141746476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.889|TWO_SIDED|95.0|-0.81|0.94||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||0.94|-0.81|0.889
71120487|NCT01300819|141746477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04||||0.043|TWO_SIDED|95.0|-2.06|-0.03||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||-0.03|-2.06|0.043
71120488|NCT01319721|141746496|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71120489|NCT01319721|141746497|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
71120490|NCT01319721|141746498|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.05
71120491|NCT01319721|141746499|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71120492|NCT01319721|141746500|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71120493|NCT00461305|141746501|SUPERIORITY_OR_OTHER||Incidence on one treatment arm|13.4|||||TWO_SIDED|95.0|9.73|17.77|||Binominal parameter by exact method||No group comparison were planned. Binomial parameter on each treatment arm was estimated by exact method.|Exact 95% confident intervals were calculated using F-distribution by treatment group. If the upper confidence limit is lower than 27.56% (threshold incidence), the treatment arm will be concluded to be acceptable. No group comparison was planned.||17.77|9.73|
71120494|NCT00461305|141746501|SUPERIORITY_OR_OTHER||Incidence on one treatment arm|7.1||||||95.0|1.98|17.29|||Binominal parameter by exact method|||Exact 95% confident intervals were calculated using F-distribution by treatment group.||17.29|1.98|
71120495|NCT04545047|141746538|SUPERIORITY||Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-2.3|3.6||||||The investigators estimated the 30-day mortality risk difference comparing patients assigned to each group. Adjustment for covariates would be carried out via inverse probability weighting.||3.60|-2.30|
71120496|NCT04545047|141746538|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.64|1.62||||||The investigators estimated the 30-day mortality hazard ratio comparing patients assigned to each group. The hazard ratio was estimated from pooled logistic models with inverse probability weighting to adjust for confounding.||1.62|0.64|
71120497|NCT01103063|141746544|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.11|STANDARD_DEVIATION|0.0647||0.12237|TWO_SIDED|95.0|0.97|1.25||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint)|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.25|0.97|0.12237
71120498|NCT01103063|141746545|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03|STANDARD_DEVIATION|0.1243||0.84117|TWO_SIDED|95.0|0.8|1.31||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint)|Mantel Haenszel||The estimated risk ratio is presented along with its SE, with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.31|0.80|0.84117
71120499|NCT01103063|141746546|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.87|STANDARD_DEVIATION|0.1745||0.4428|TWO_SIDED|95.0|0.62|1.23||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.23|0.62|0.4428
71120500|NCT01103063|141746547|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.91|STANDARD_DEVIATION|0.1882||0.6086|TWO_SIDED|95.0|0.63|1.31||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.31|0.63|0.6086
71120501|NCT01103063|141746548|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9|STANDARD_DEVIATION|0.2866||0.7035|TWO_SIDED|95.0|0.51|1.57||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.57|0.51|0.7035
71120502|NCT01103063|141746549|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03|STANDARD_DEVIATION|0.04||0.4605|TWO_SIDED|95.0|0.95|1.11||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.11|0.95|0.4605
71120503|NCT01103063|141746550|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.93|STANDARD_DEVIATION|0.1817||0.7105|TWO_SIDED|95.0|0.65|1.33||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.33|0.65|0.7105
71120504|NCT01103063|141746551|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84|STANDARD_DEVIATION|0.1842||0.3468|TWO_SIDED|95.0|0.59|1.21||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.21|0.59|0.3468
71120505|NCT01103063|141746552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.02||0.0011|TWO_SIDED|95.0|-0.08|-0.02||Analysis based on an ANOVA model with model terms for treatment group and randomization stratification variable. A negative mean difference between treatment groups favors Azithromycin + Chloroquine (reduction in number of STIs).|ANOVA|||The 2-sided P-value tests the null hypothesis that the mean difference is 0 (treatment group equality) versus not equal 0.||-0.02|-0.08|0.0011
71120506|NCT01103063|141746553|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08|STANDARD_DEVIATION|0.0604||0.2265|TWO_SIDED|95.0|0.96|1.21||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.21|0.96|0.2265
71120507|NCT01103063|141746554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.05||0.0131|TWO_SIDED|95.0|-0.24|-0.03||Analysis based on an ANCOVA model with model terms for baseline value, treatment group and randomization stratification variable.|ANCOVA|||The 2-sided P-value tests the null hypothesis that the mean difference is 0 (treatment group equality) versus not equal 0.||-0.03|-0.24|0.0131
71120508|NCT01103063|141746555|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9|STANDARD_DEVIATION|0.2694||0.6978|TWO_SIDED|95.0|0.53|1.53||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its SE, with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.53|0.53|0.6978
71120509|NCT01103063|141746556|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.14|STANDARD_DEVIATION|0.2908||0.6542|TWO_SIDED|95.0|0.64|2.01||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its SE, with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||2.01|0.64|0.6542
71120510|NCT01103063|141746557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|19.71||0.9145|TWO_SIDED|95.0|-36.5|40.8||Analysis based on an ANOVA model with model terms for treatment group and randomization stratification variable.|ANOVA|||The 2-sided P-value tests the null hypothesis that the mean difference is 0 (treatment group equality) versus not equal 0.||40.8|-36.5|0.9145
71120511|NCT01103063|141746558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.09|-0.04||Analysis based on an ANOVA model with model terms for treatment group and randomization stratification variable. A negative mean difference between treatment groups favors Azithromycin + Chloroquine (reduction in number of symptomatic malaria).|ANOVA|||The 2-sided P-value tests the null hypothesis that the mean difference is 0 (treatment group equality) versus not equal 0.||-0.04|-0.09|<0.0001
71120512|NCT01103063|141746559|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49|STANDARD_DEVIATION|0.1221|<|0.0001|TWO_SIDED|95.0|0.38|0.62||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.62|0.38|<0.0001
70954260|NCT00688870|141411078|SUPERIORITY_OR_OTHER_LEGACY|||||||0.497||95.0|||||Fisher Exact|||For Redness - Moderate, Fisher exact test was used to calculate p-value.||||0.497
71081215|NCT01763827|141669156|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.58|STANDARD_ERROR_OF_MEAN|1.63|<|0.001|TWO_SIDED|95.0|-38.79|-32.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-32.38|-38.79|<0.001
71120513|NCT01103063|141746560|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.62|STANDARD_DEVIATION|0.2295||0.036|TWO_SIDED|95.0|0.39|0.97||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its SE, with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.97|0.39|0.0360
71120514|NCT01103063|141746561|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81|STANDARD_DEVIATION|0.163||0.1975|TWO_SIDED|95.0|0.59|1.12||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.12|0.59|0.1975
71120515|NCT01103063|141746562|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.66|STANDARD_DEVIATION|0.5675||0.4655|TWO_SIDED|95.0|0.22|2.01||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its SE, with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||2.01|0.22|0.4655
71120516|NCT01103063|141746563|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75|STANDARD_DEVIATION|0.0918||0.0016|TWO_SIDED|95.0|0.62|0.9||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.90|0.62|0.0016
70855088|NCT02880956|141198374|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|1.53|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71081216|NCT01763827|141669156|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.49|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-38.44|-32.53||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-32.53|-38.44|<0.001
71081217|NCT01763827|141669157|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-49.81|STANDARD_ERROR_OF_MEAN|1.79|<|0.001|TWO_SIDED|95.0|-53.34|-46.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-46.27|-53.34|<0.001
70855089|NCT02880956|141198374|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.211||0.163|TWO_SIDED|95.0|-0.711|0.12||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.120|-0.711|0.163
70855090|NCT02880956|141198374|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|1.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71081218|NCT01763827|141669157|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-51.19|STANDARD_ERROR_OF_MEAN|1.67|<|0.001|TWO_SIDED|95.0|-54.49|-47.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-47.90|-54.49|<0.001
71081219|NCT01763827|141669157|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.23|STANDARD_ERROR_OF_MEAN|1.78|<|0.001|TWO_SIDED|95.0|-38.74|-31.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-31.71|-38.74|<0.001
70855091|NCT02880956|141198374|SUPERIORITY||LS Mean of Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.205||0.424|TWO_SIDED|95.0|-0.567|0.239||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.239|-0.567|0.424
70855092|NCT02880956|141198374|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|1.61|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71120517|NCT01103063|141746564|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.34|STANDARD_DEVIATION|0.5338||0.1113|TWO_SIDED|95.0|0.82|6.66||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||6.66|0.82|0.1113
71120518|NCT01103063|141746565|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.25|STANDARD_DEVIATION|0.6386||0.0284|TWO_SIDED|95.0|0.07|0.86||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.86|0.07|0.0284
71120519|NCT01103063|141746566|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.46|STANDARD_DEVIATION|0.3291||0.0188|TWO_SIDED|95.0|0.24|0.88||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.88|0.24|0.0188
71120520|NCT01103063|141746567|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77|STANDARD_DEVIATION|0.1336||0.0527|TWO_SIDED|95.0|0.59|1.0||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.00|0.59|0.0527
71120521|NCT01103063|141746568|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.73|STANDARD_DEVIATION|0.1536||0.0384|TWO_SIDED|95.0|0.54|0.98||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.98|0.54|0.0384
71120522|NCT01103063|141746569|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.09|STANDARD_DEVIATION|0.8648||0.3942|TWO_SIDED|95.0|0.38|11.38||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||11.38|0.38|0.3942
71120523|NCT01103063|141746570|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.39|STANDARD_DEVIATION|0.4439||0.0332|TWO_SIDED|95.0|0.16|0.93||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.93|0.16|0.0332
71120524|NCT01103063|141746571|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.61|STANDARD_DEVIATION|0.4195||0.2321|TWO_SIDED|95.0|0.27|1.38||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.38|0.27|0.2321
71120525|NCT01103063|141746572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.76||||1|TWO_SIDED||||||Fisher Exact|||Statistical analysis for Visit 6 presented above.||||1.0000
71120526|NCT01103063|141746572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED||||||Fisher Exact|||Statistical analysis for Visit 7 presented above.||||1.0000
71120527|NCT01103063|141746573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED||||||Fisher Exact|||Statistical analysis for Visit 6 presented above.||||1.0000
71120528|NCT01103063|141746573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED||||||Fisher Exact|||Statistical analysis for Visit 7 presented above.||||1.0000
71120529|NCT01437098|141746579|SUPERIORITY_OR_OTHER||Proportion of IF Implanted Subjects|91.7|||<|0.001|TWO_SIDED|95.0|77.5|98.2|||Exact binomial|||||98.2|77.5|<0.001
71120530|NCT00496197|141746632|SUPERIORITY_OR_OTHER||percentage of participants|83.7|||||TWO_SIDED|95.0|78.7|88.8|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at EOT||88.8|78.7|
71120531|NCT00496197|141746633|SUPERIORITY_OR_OTHER||percentage of participants|93.0|||||TWO_SIDED|95.0|89.4|96.7|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Clinical response of Success (cure or improvement) at EOT||96.7|89.4|
71120532|NCT00496197|141746634|SUPERIORITY_OR_OTHER||percentage of participants|95.3|||||TWO_SIDED|95.0|92.3|98.3|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Microbiological response of Success (eradication or presumed eradication) at EOT||98.3|92.3|
71120533|NCT00496197|141746635|SUPERIORITY_OR_OTHER||percentage of participants|88.5|||||TWO_SIDED|95.0|84.4|92.6|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at EOIV||92.6|84.4|
71120534|NCT00496197|141746636|SUPERIORITY_OR_OTHER||percentage of participants|93.1|||||TWO_SIDED|95.0|89.8|96.4|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Clinical response of Success (cure or improvement) at EOIV||96.4|89.8|
71120535|NCT00496197|141746637|SUPERIORITY_OR_OTHER||percentage of participants|92.6|||||TWO_SIDED|95.0|89.3|95.9|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Microbiological response of Success (eradication or presumed eradication) at EOIV||95.9|89.3|
71120536|NCT00496197|141746638|SUPERIORITY_OR_OTHER||percentage of participants|76.3|||||TWO_SIDED|95.0|70.3|82.3|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at Week 2 Follow-up||82.3|70.3|
71120537|NCT00496197|141746639|SUPERIORITY_OR_OTHER||percentage of participants|94.8|||||TWO_SIDED|95.0|91.5|98.1|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Clinical response of Success (cure or improvement) at Week 2 Follow-up||98.1|91.5|
71120538|NCT00496197|141746640|SUPERIORITY_OR_OTHER||percentage of participants|95.4|||||TWO_SIDED|95.0|92.2|98.5|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Microbiological response of Success (eradication or presumed eradication) at Week 2 Follow-up||98.5|92.2|
71120539|NCT00496197|141746641|SUPERIORITY_OR_OTHER||percentage of participants|70.1|||||TWO_SIDED|95.0|63.5|76.6|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at Week 6 Follow-up (EOS)||76.6|63.5|
71120540|NCT00496197|141746642|SUPERIORITY_OR_OTHER||percentage of participants|93.6|||||TWO_SIDED|95.0|89.7|97.4|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Clinical response of Success (cure or improvement) at Week 6 Follow-up (EOS)||97.4|89.7|
71120541|NCT00496197|141746643|SUPERIORITY_OR_OTHER||percentage of participants|93.6|||||TWO_SIDED|95.0|89.7|97.4|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Microbiological response of Success (eradication or presumed eradication) at Week 6 Follow-up (EOS)||97.4|89.7|
71120542|NCT00496197|141746644|SUPERIORITY_OR_OTHER||percentage of participants|82.5|||||TWO_SIDED|95.0|75.7|89.3|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at EOT||89.3|75.7|
71120543|NCT00496197|141746645|SUPERIORITY_OR_OTHER||percentage of participants|85.6|||||TWO_SIDED|95.0|79.8|91.4|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at EOIV||91.4|79.8|
71120544|NCT00496197|141746646|SUPERIORITY_OR_OTHER||percentage of participants|76.7|||||TWO_SIDED|95.0|69.0|84.4|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at Week 2 Follow-up||84.4|69.0|
71120545|NCT00496197|141746647|SUPERIORITY_OR_OTHER||percentage of participants|67.6|||||TWO_SIDED|95.0|58.9|76.3|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at Week 6 Follow-up (EOS)||76.3|58.9|
71120546|NCT01344538|141746656|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71120547|NCT00929773|141746729|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
71120548|NCT00929773|141746730|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<.0001
71120549|NCT00929773|141746731|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
71120550|NCT00929773|141746732|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
71120551|NCT00929773|141746733|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
71120552|NCT00929773|141746734|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
71120553|NCT02583230|141746756|SUPERIORITY|||||||0.0005|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was used to evaluate the change in PHQ-9 total scores over the eight-week study period.||||||.0005
71120554|NCT02583230|141746757|SUPERIORITY|||||||0.0008|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was used to evaluate the change in QIDS total scores over the eight-week study period.||||||.0008
71120555|NCT01431014|141746811|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||>0.05
71120556|NCT02685748|141746812|OTHER||Mean Difference (Final Values)|-0.077|STANDARD_ERROR_OF_MEAN|0.444||0.863|TWO_SIDED|95.0|-0.969|0.815|||t-test, 2 sided|||||0.815|-0.969|0.863
71120557|NCT02685748|141746813|OTHER|T test for independent samples|Mean Difference (Final Values)|3.616|STANDARD_ERROR_OF_MEAN|2.364||0.133|TWO_SIDED|95.0|-1.147|8.379|||t-test, 2 sided|||||8.379|-1.147|0.133
71120558|NCT02685748|141746814|OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.43||1.607|TWO_SIDED|95.0|-1.1553|0.172|||t-test, 2 sided|||||0.172|-1.1553|1.607
71120559|NCT02685748|141746815|OTHER||Mean Difference (Final Values)|-1.282|STANDARD_ERROR_OF_MEAN|1.754||0.468|TWO_SIDED|95.0|-4.807|2.241|||t-test, 2 sided|||||2.241|-4.807|0.468
71120560|NCT02685748|141746816|OTHER||Mean Difference (Final Values)|-0.051|STANDARD_ERROR_OF_MEAN|0.406||0.899|TWO_SIDED|95.0|-0.869|0.765|||t-test, 2 sided|||||0.765|-0.869|0.899
71120561|NCT02685748|141746817|OTHER||Mean Difference (Final Values)|7.05|STANDARD_DEVIATION|6.797||0.305|TWO_SIDED|95.0|-6.602|20.703|||t-test, 2 sided|||||20.703|-6.602|0.305
71120562|NCT02685748|141746818|OTHER||Mean Difference (Final Values)|160.298|STANDARD_ERROR_OF_MEAN|159.525||0.32|TWO_SIDED|95.0|-160.118|480.714|||t-test, 2 sided|||||480.714|-160.118|0.320
71081220|NCT01763827|141669157|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.21|STANDARD_ERROR_OF_MEAN|1.68|<|0.001|TWO_SIDED|95.0|-36.51|-29.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-29.90|-36.51|<0.001
71081221|NCT01763827|141669158|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.09|STANDARD_ERROR_OF_MEAN|1.82|<|0.001|TWO_SIDED|95.0|-50.67|-43.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-43.51|-50.67|<0.001
71120563|NCT02685748|141746819|OTHER||Mean Difference (Final Values)|-1.495|STANDARD_ERROR_OF_MEAN|3.558||0.676|TWO_SIDED|95.0|-8.642|5.651|||t-test, 2 sided|||||5.651|-8.642|0.676
71120564|NCT00328653|141746820|SUPERIORITY|Comparisons of NOVA22007 0.05% to vehicle|M-H Chi-square|1.2187||||0.2699|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.2699
71120565|NCT00328653|141746820|SUPERIORITY|Comparisons of NOVA22007 0.1% to vehicle|M-H Chi-square|1.2359||||0.2719|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.2719
71120566|NCT00328653|141746823|SUPERIORITY|Comparisons of NOVA22007 0.05% to vehicle|M-H-Chi-square|4.2925||||0.0386|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0386
71120567|NCT00328653|141746823|SUPERIORITY|Comparisons of NOVA22007 0.1% to vehicle|M-H-Chi-square|5.3007||||0.0208|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0208
71120568|NCT03832114|141746851|OTHER|Log Ratio to Baseline|Mean Difference (Final Values)|0.55||||0.0003|TWO_SIDED|80.0|0.46|0.65|||Mixed Model Repeated Measures (MMRM)|||||0.65|0.46|0.0003
71120569|NCT03832114|141746852|OTHER||Median Difference (Final Values)|-2.5||||0.0313|TWO_SIDED|80.0|-3.75|-0.75|||Wilcoxon (Mann-Whitney)|||||-0.75|-3.75|0.0313
71120570|NCT03832114|141746853|OTHER||Mean Difference (Final Values)|0.55||||0.0003|TWO_SIDED|80.0|0.46|0.65|||Mixed Model Repeated Measures (MMRM)|||Day 84||0.65|0.46|0.0003
71120571|NCT03832114|141746853|OTHER||Mean Difference (Final Values)|0.79||||0.4766|TWO_SIDED|80.0|0.49|1.28|||Mixed Model Repeated Measures (MMRM)|||Day 84||1.28|0.49|0.4766
71120572|NCT03832114|141746853|OTHER||Mean Difference (Final Values)|0.59||||0.0002|TWO_SIDED|80.0|0.51|0.69|||Mixed Model of Repeated Measures (MMRM)|||Overall- Day 84||0.69|0.51|0.0002
71120573|NCT03832114|141746854|OTHER||Mean Difference (Final Values)|0.57||||0.0011|TWO_SIDED|80.0|0.47|0.68|||Mixed Model Repeated Measures (MMRM|||Day 84||0.68|0.47|0.0011
71081222|NCT01763827|141669158|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.93|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-54.27|-47.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-47.59|-54.27|<0.001
71120574|NCT03832114|141746854|OTHER||Mean Difference (Final Values)|1.0||||0.9998|TWO_SIDED|80.0|0.75|1.33|||Mixed Model Repeated Measures (MMRM)|||Day 84||1.33|0.75|0.9998
71120575|NCT03832114|141746854|OTHER||Mean Difference (Final Values)|0.66||||0.0016|TWO_SIDED|80.0|0.56|0.77|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 84||0.77|0.56|0.0016
71120576|NCT03832114|141746855|OTHER||Mean Difference (Final Values)|0.55|||<|0.0001|TWO_SIDED|80.0|0.47|0.64|||Mixed Model Repeated Measures (MRM)|||Day 84||0.64|0.47|<0.0001
71120577|NCT03832114|141746855|OTHER||Mean Difference (Final Values)|0.61||||0.3707|TWO_SIDED|80.0|0.3|1.27|||Mixed Model Repeated Measures (MMRM)|||Day 84||1.27|0.30|0.3707
71120578|NCT03832114|141746855|OTHER||Mean Difference (Final Values)|0.6||||0.0002|TWO_SIDED|80.0|0.51|0.71|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 84||0.71|0.51|0.0002
71120579|NCT03832114|141746856|OTHER||Mean Difference (Final Values)|0.57||||0.0018|TWO_SIDED|80.0|0.47|0.7|||Mixed Model Repeated Measures (MMRM)|||Day 84||0.70|0.47|0.0018
71120580|NCT03832114|141746856|OTHER||Mean Difference (Final Values)|0.81||||0.1632|TWO_SIDED|80.0|0.67|0.98|||Mixed Model Repeated Measures (MMRM)|||Day 84||0.98|0.67|0.1632
71120581|NCT03832114|141746856|OTHER||Mean Difference (Final Values)|0.67||||0.004|TWO_SIDED|80.0|0.57|0.79|||Mixed Model Repeated Measure (MMRM)|||Overall- Day 84||0.79|0.57|0.0040
71120582|NCT03832114|141746857|OTHER||Mean Difference (Final Values)|2.59||||0.1795|TWO_SIDED|80.0|0.12|5.06|||Mixed Model of Repeated Measures (MMRM)|||Day 84||5.06|0.12|0.1795
71120583|NCT03832114|141746857|OTHER||Mean Difference (Final Values)|-0.61||||0.7763|TWO_SIDED|0.7763|-3.36|2.15|||Mixed Model Repeated Measures (MMRM)|||Day 84||2.15|-3.36|0.7763
71120584|NCT03832114|141746857|OTHER||Mean Difference (Final Values)|1.32||||0.3754|TWO_SIDED|80.0|-0.59|3.22|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 84||3.22|-0.59|0.3754
71120585|NCT03832114|141746858|OTHER||Mean Difference (Final Values)|-5.04||||0.1364|TWO_SIDED|80.0|-9.36|-0.72|||Mixed Model Repeated Measuers (MMRM)|||Day 84||-0.72|-9.36|0.1364
71120586|NCT03832114|141746858|OTHER||Mean Difference (Final Values)|7.17||||0.3038|TWO_SIDED|80.0|-1.79|16.13|||Mixed Model Repeated Measures (MMRM)|||Day 84||16.13|-1.79|0.3038
71120587|NCT03832114|141746858|OTHER||Mean Difference (Final Values)|-0.77||||0.8352|TWO_SIDED|80.0|-5.56|4.01|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 84||4.01|-5.56|0.8352
71120588|NCT03832114|141746859|OTHER||Mean Difference (Final Values)|1.07||||0.2752|TWO_SIDED|80.0|0.99|1.17|||Mixed Model Repeated Measures (MMRM)|||Day 84||1.17|0.99|0.2752
71120589|NCT03832114|141746859|OTHER||Mean Difference (Final Values)|1.2||||0.476|TWO_SIDED|80.0|0.83|1.72|||Mixed Model Repeated Measures (MMRM)|||Day 84||1.72|0.83|0.476
71120590|NCT03832114|141746859|OTHER||Mean Difference (Final Values)|1.1||||0.1963|TWO_SIDED|80.0|1.0|1.2|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 84||1.20|1.00|0.1963
71120591|NCT03832114|141746861|OTHER||Mean Difference (Final Values)|0.56|||<|0.0001|TWO_SIDED|80.0|0.48|0.65|||Mixed Model Repeated Measures (MMRM)|||Day 64||0.65|0.48|<0.0001
71120592|NCT03832114|141746861|OTHER||Mean Difference (Final Values)|0.99||||0.9544|TWO_SIDED|80.0|0.76|1.28|||Mixed Model Repeated Measures (MMRM)|||Day 64||1.28|0.76|0.9544
71120593|NCT03832114|141746861|OTHER||Mean Difference (Final Values)|0.64|||<|0.0001|TWO_SIDED|80.0|0.56|0.72|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 64||0.72|0.56|<.0001
71120594|NCT03832114|141746862|OTHER||Mean Difference (Final Values)|0.59|||<|0.0001|TWO_SIDED|80.0|0.5|0.69|||Mixed Model Repeated Measures (MMRM)|||Day 64||0.69|0.50|<.0001
70943920|NCT03638258|141387818|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.01||||||ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.|ANCOVA|||Difference from vehicle cream at Week 12||||0.01
71081223|NCT01763827|141669158|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.57|STANDARD_ERROR_OF_MEAN|1.82|<|0.001|TWO_SIDED|95.0|-37.15|-29.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-29.99|-37.15|<0.001
71081224|NCT01763827|141669158|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.64|STANDARD_ERROR_OF_MEAN|1.71|<|0.001|TWO_SIDED|95.0|-37.99|-31.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-31.28|-37.99|<0.001
71081225|NCT01763827|141669159|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.81|STANDARD_ERROR_OF_MEAN|1.91|<|0.001|TWO_SIDED|95.0|-51.56|-44.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-44.05|-51.56|<0.001
71081226|NCT01763827|141669159|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-48.43|STANDARD_ERROR_OF_MEAN|1.85|<|0.001|TWO_SIDED|95.0|-52.07|-44.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-44.79|-52.07|<0.001
71120595|NCT03832114|141746862|OTHER||Median Difference (Final Values)|0.87||||0.6209|TWO_SIDED|80.0|0.6|1.26|||Mixed Model Repeated Measures (MMRM)|||Day 64||1.26|0.60|0.6209
71120596|NCT03832114|141746862|OTHER||Mean Difference (Final Values)|0.63||||0.0002|TWO_SIDED|80.0|0.54|0.73|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 64||0.73|0.54|0.0002
71120597|NCT03054350|141746898|SUPERIORITY||Least squares mean difference|1.19|STANDARD_ERROR_OF_MEAN|0.314||0.0004|TWO_SIDED|95.0|0.56|1.82|||ANCOVA|The analysis of covariance (ANCOVA) model includes treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||||1.82|0.56|0.0004
71120598|NCT03054350|141746898|SUPERIORITY||Least squares mean difference|1.56|STANDARD_ERROR_OF_MEAN|0.315|<|0.0001|TWO_SIDED|95.0|0.93|2.19|||ANCOVA|The ANCOVA model includes treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||||2.19|0.93|<0.0001
71120599|NCT03054350|141746898|SUPERIORITY||Least squares mean difference|1.89|STANDARD_ERROR_OF_MEAN|0.326|<|0.0001|TWO_SIDED|95.0|1.23|2.54|||ANCOVA|The ANCOVA model includes treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||||2.54|1.23|<0.0001
70855093|NCT02880956|141198374|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.213||0.664|TWO_SIDED|95.0|-0.51|0.326||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.326|-0.510|0.664
71120600|NCT03054350|141746904|SUPERIORITY||Least squares mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.122||0.0232|TWO_SIDED|95.0|0.04|0.54|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups;1 placebo group) and pre-treatment Hb value as a covariate.||RBC Count||0.54|0.04|0.0232
71120601|NCT03054350|141746904|SUPERIORITY||Least squares mean difference|0.38|STANDARD_ERROR_OF_MEAN|0.121||0.0033|TWO_SIDED|95.0|0.13|0.62|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||RBC Count||0.62|0.13|0.0033
71120602|NCT03054350|141746904|SUPERIORITY||Least squares mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.12||0.0002|TWO_SIDED|95.0|0.26|0.74|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||RBC Count||0.74|0.26|0.0002
71120603|NCT03054350|141746904|SUPERIORITY||Least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.008||0.3289|TWO_SIDED|94.0|-0.01|0.02|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Absolute Reticulocyte Count||0.02|-0.01|0.3289
70943921|NCT03638258|141387819|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.255|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 4||||0.255
70943922|NCT03638258|141387819|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.687|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream on Week 4||||0.687
71081227|NCT01763827|141669159|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.04|STANDARD_ERROR_OF_MEAN|1.9|<|0.001|TWO_SIDED|95.0|-37.78|-30.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-30.30|-37.78|<0.001
71081228|NCT01763827|141669159|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.57|STANDARD_ERROR_OF_MEAN|1.85|<|0.001|TWO_SIDED|95.0|-36.21|-28.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-28.92|-36.21|<0.001
71120604|NCT03054350|141746904|SUPERIORITY||Least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.007||0.2607|TWO_SIDED|95.0|-0.01|0.02|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Absolute Reticulocyte Count||0.02|-0.01|0.2607
71120605|NCT03054350|141746904|SUPERIORITY||Least squares mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.007||0.0252|TWO_SIDED|95.0|0.0|0.03|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Absolute Reticulocyte Count||0.03|0.00|0.0252
70855094|NCT02880956|141198374|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855095|NCT02880956|141198374|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.229||0.417|TWO_SIDED|95.0|-0.638|0.265||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.265|-0.638|0.417
70855096|NCT02880956|141198374|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|1.71|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855097|NCT02880956|141198374|SUPERIORITY||LS Mean of Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.227||0.217|TWO_SIDED|95.0|-0.727|0.166||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.166|-0.727|0.217
70855098|NCT02880956|141198374|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|1.68|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855099|NCT02880956|141198374|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.231||0.753|TWO_SIDED|95.0|-0.381|0.526||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.526|-0.381|0.753
70855100|NCT02880956|141198374|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.8|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855101|NCT02880956|141198374|SUPERIORITY||LS Mean of Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.257||0.362|TWO_SIDED|95.0|-0.74|0.27||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.270|-0.740|0.362
70855102|NCT02880956|141198374|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|1.62|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855103|NCT02880956|141198374|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.256||0.78|TWO_SIDED|95.0|-0.432|0.575||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.575|-0.432|0.780
70943923|NCT03638258|141387819|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.045|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 6||||0.045
70943924|NCT03638258|141387819|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.059|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 6||||0.059
70943925|NCT03638258|141387819|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.051|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 8||||0.051
70943926|NCT03638258|141387819|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.013|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 8||||0.013
70943927|NCT03638258|141387819|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.036|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 12||||0.036
70855104|NCT02880956|141198374|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.72|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855105|NCT02880956|141198374|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.263||0.974|TWO_SIDED|95.0|-0.526|0.509||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.509|-0.526|0.974
70855106|NCT02880956|141198374|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|1.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855107|NCT02880956|141198375|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.139||0.976|TWO_SIDED|95.0|-0.269|0.278||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.278|-0.269|0.976
71120606|NCT03054350|141746906|SUPERIORITY||Least squares mean difference|3.31|STANDARD_ERROR_OF_MEAN|1.303||0.0154|TWO_SIDED|95.0|0.67|5.94|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Hematocrit||5.94|0.67|0.0154
70855108|NCT02880956|141198375|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|1.1|||TWO_SIDED|||||||||Week 24||||
70855109|NCT02880956|141198375|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.137||0.85|TWO_SIDED|95.0|-0.244|0.296||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.296|-0.244|0.850
70855110|NCT02880956|141198375|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|1.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855111|NCT02880956|141198375|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.141||0.981|TWO_SIDED|95.0|-0.281|0.275||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.275|-0.281|0.981
70855112|NCT02880956|141198375|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|1.05|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71120607|NCT03054350|141746906|SUPERIORITY||Least squares mean difference|4.61|STANDARD_ERROR_OF_MEAN|1.261||0.0008|TWO_SIDED|95.0|2.06|7.16|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Hematocrit||7.16|2.06|0.0008
70855113|NCT02880956|141198375|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.163||0.989|TWO_SIDED|95.0|-0.323|0.318||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.318|-0.323|0.989
70855114|NCT02880956|141198375|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|1.32|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855115|NCT02880956|141198375|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.159||0.97|TWO_SIDED|95.0|-0.319|0.307||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.307|-0.319|0.970
70855116|NCT02880956|141198375|SUPERIORITY||effect size|0.0|STANDARD_DEVIATION|1.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855117|NCT02880956|141198375|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.164||0.215|TWO_SIDED|95.0|-0.526|0.119||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.119|-0.526|0.215
70855118|NCT02880956|141198375|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|1.18|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855119|NCT02880956|141198375|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.163||0.665|TWO_SIDED|95.0|-0.392|0.25||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.250|-0.392|0.665
70855120|NCT02880956|141198375|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.28|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855121|NCT02880956|141198375|SUPERIORITY||LS Mean of Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.162||0.059|TWO_SIDED|95.0|-0.625|0.012||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.012|-0.625|0.059
70855122|NCT02880956|141198375|SUPERIORITY||Effect size/pooled SD|0.28|STANDARD_DEVIATION|1.11|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71120608|NCT03054350|141746906|SUPERIORITY||Least squares mean difference|5.93|STANDARD_ERROR_OF_MEAN|1.296|<|0.0001|TWO_SIDED|95.0|3.31|8.56|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Hematocrit||8.56|3.31|<0.0001
71120609|NCT03054350|141746906|SUPERIORITY||Least squares mean difference|0.25|STANDARD_ERROR_OF_MEAN|0.273||0.3572|TWO_SIDED|95.0|-0.3|0.81|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Reticulocytes||0.81|-0.30|0.3572
70943928|NCT03638258|141387819|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 12||||0.001
71081229|NCT01763827|141669160|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.93|STANDARD_ERROR_OF_MEAN|1.56|<|0.001|TWO_SIDED|95.0|-42.0|-35.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-35.86|-42.00|<0.001
71081230|NCT01763827|141669160|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.83|STANDARD_ERROR_OF_MEAN|1.81|<|0.001|TWO_SIDED|95.0|-49.39|-42.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-42.27|-49.39|<0.001
71081231|NCT01763827|141669160|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-29.36|STANDARD_ERROR_OF_MEAN|1.56|<|0.001|TWO_SIDED|95.0|-32.43|-26.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-26.28|-32.43|<0.001
71081232|NCT01763827|141669160|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.51|STANDARD_ERROR_OF_MEAN|1.81|<|0.001|TWO_SIDED|95.0|-31.08|-23.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-23.94|-31.08|<0.001
71081233|NCT01763827|141669161|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.63|STANDARD_ERROR_OF_MEAN|1.69|<|0.001|TWO_SIDED|95.0|-42.97|-36.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-36.30|-42.97|<0.001
71081234|NCT01763827|141669161|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.67|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-48.66|-40.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-40.68|-48.66|<0.001
71081235|NCT01763827|141669161|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.42|STANDARD_ERROR_OF_MEAN|1.68|<|0.001|TWO_SIDED|95.0|-31.73|-25.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-25.10|-31.73|<0.001
71081236|NCT01763827|141669161|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.31|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-29.31|-21.31||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-21.31|-29.31|<0.001
71120610|NCT03054350|141746906|SUPERIORITY||Least squares mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.252||0.4758|TWO_SIDED|95.0|-0.33|0.69|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Reticulocytes||0.69|-0.33|0.4758
71081237|NCT01763827|141669162|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-49.12|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-53.12|-45.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-45.12|-53.12|<0.001
71081238|NCT01763827|141669162|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.95|STANDARD_ERROR_OF_MEAN|2.12|<|0.001|TWO_SIDED|95.0|-59.12|-50.78||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-50.78|-59.12|<0.001
71081239|NCT01763827|141669162|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.73|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-38.73|-30.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-30.73|-38.73|<0.001
71081240|NCT01763827|141669162|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.62|STANDARD_ERROR_OF_MEAN|2.13|<|0.001|TWO_SIDED|95.0|-40.81|-32.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-32.42|-40.81|<0.001
71081241|NCT01763827|141669163|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-49.57|STANDARD_ERROR_OF_MEAN|2.14|<|0.001|TWO_SIDED|95.0|-53.78|-45.36||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-45.36|-53.78|<0.001
71120611|NCT03054350|141746906|SUPERIORITY||Least squares mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.254||0.2048|TWO_SIDED|95.0|-0.19|0.84|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Reticulocytes||0.84|-0.19|0.2048
71120612|NCT03054350|141746908|SUPERIORITY|||||||0.9373|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Iron||||0.9373
71120613|NCT03054350|141746908|SUPERIORITY|||||||0.6623|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Iron||||0.6623
71120614|NCT03054350|141746908|SUPERIORITY|||||||0.9374|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Iron||||0.9374
70943929|NCT02630706|141387826|SUPERIORITY|Constrained longitudinal data analysis (cLDA)|Difference in the LSM vs. placebo|-0.69|||<|0.001|TWO_SIDED|95.0|-0.85|-0.52||cLDA model with fixed effects for treatment, time, anti-AHA status at Screening (metformin alone, metformin + another AHA), country (China, other), baseline eGFR (continuous) and the interaction of time by treatment.|cLDA|Least squares means = LSM||The primary hypothesis of the study was the mean change from baseline in HbA1c for 15 mg ertugliflozin is greater than that for placebo.||-0.52|-0.85|<0.001
71120615|NCT03054350|141746908|SUPERIORITY|||||||0.2085|||||||ANCOVA|test of treatment group difference based on ANCOVA model||TIBC||||0.2085
71120616|NCT03054350|141746908|SUPERIORITY|||||||0.0016|||||||ANCOVA|test of treatment group difference based on ANCOVA model||TIBC||||0.0016
71120617|NCT03054350|141746908|SUPERIORITY|||||||0.0001|||||||ANCOVA|test of treatment group difference based on ANCOVA model||TIBC||||0.0001
71120618|NCT03054350|141746910|SUPERIORITY|||||||0.2708|||||||ANCOVA|test of treatment group difference based on ANCOVA model||||||0.2708
71120619|NCT03054350|141746910|SUPERIORITY|||||||0.0966|||||||ANCOVA|test of treatment group difference based on ANCOVA model||||||0.0966
71120620|NCT03054350|141746910|SUPERIORITY|||||||0.0424|||||||ANCOVA|test of treatment group difference based on ANCOVA model||||||0.0424
71120621|NCT03054350|141746912|SUPERIORITY|||||||0.0207|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Ferritin||||0.0207
71120622|NCT03054350|141746912|SUPERIORITY|||||||0.0022|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Ferritin||||0.0022
71120623|NCT03054350|141746912|SUPERIORITY||||||<|0.0001|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Ferritin||||<0.0001
71120624|NCT03054350|141746912|SUPERIORITY|||||||0.0062|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Hepcidin||||0.0062
71120625|NCT03054350|141746912|SUPERIORITY|||||||0.0002|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Hepcidin||||0.0002
71120626|NCT03054350|141746912|SUPERIORITY||||||<|0.0001||||||test of treatment group difference based on ANCOVA model|ANCOVA|||Hepcidin||||<0.0001
71120627|NCT02240368|141746960|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||bootstrap|||||||<0.01
71120628|NCT02240368|141746961|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||bootstrap|||||||<0.01
71120629|NCT02240368|141746962|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
71120630|NCT02240368|141746963|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71120631|NCT04612842|141746988|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71120632|NCT02419131|141747004|SUPERIORITY|Superiority of the experimental arms (CBTH and CPT) compared to usual care (TAU)|Aggregated contrast CBTH to TAU|-3.4|||<|0.001|TWO_SIDED|95.0|-5.4|-1.4||p-value represents an aggregate of post-treatment outcomes (i.e., post-treatment, 3-month, and 6-month outcomes entered simultaneously into the GLMM to represent a single metric of all post-treatment assessment intervals into one estimate).|Mixed Models Analysis|Outcome observations at posttreatment, 3-month and 6-month follow-ups were entered simultaneously into the mixed model to provide a single inference.|Contrast of aggregated post-treatment outcomes of HIT-6 total score for CBTH compared to TAU|Sample size based on 2-tailed specified joint superiority testing of 2 primary outcomes at α = .025 and power of 0.80 to detect an effect size (d) of 0.52 for both primary outcomes (representing a clinically significant change of 2.8 points on the HIT-6). The primary analysis set was intention to treat (ITT). multiple imputation accounted for missing data in ITT. Missing outcome scores at posttreatment, 3-month, and 6-month follow-ups were multiply imputed (m = 100) using multilevel models.||-1.4|-5.4|<0.001
71120633|NCT02419131|141747004|SUPERIORITY|See previous section for analysis|Aggregated contrast CPT to TAU|-1.4||||0.21|TWO_SIDED|95.0|-3.7|0.8||For comparison of post-treatment HIT-6 total score between CPT and TAU|Mixed Models Analysis|See above for details.|See above.|See previous section for power||0.8|-3.7|0.21
71120634|NCT02419131|141747005|SUPERIORITY|Key parameters and details the same as HIT-6 described above.|Aggregated contrast CBTH to TAU|-6.5||||0.04|TWO_SIDED|95.0|-12.7|-0.3||Contrast of aggregate post-treatment outcomes between CBTH and TAU|Mixed Models Analysis|Contrast of aggregate post-treatment outcomes between CBTH and TAU||Same sample size calculation as HIT-6 analyses, powered to detect a difference of 8.2 points on the PCL-5 total score.||-0.3|-12.7|0.04
71120635|NCT02419131|141747005|SUPERIORITY|Contrast of aggregate post-treatment outcomes between CPT and TAU|Aggregated contrast CPT to TAU|-8.9||||0.01|TWO_SIDED|95.0|-15.9|-1.9||Contrast of aggregate post-treatment outcomes between CPT and TAU|Mixed Models Analysis|Contrast of aggregate post-treatment outcomes between CPT and TAU||See above.||-1.9|-15.9|0.01
71120636|NCT00089986|141747030|SUPERIORITY_OR_OTHER||Rate difference|1.1||||0.329|ONE_SIDED|90.0|-2.1||||Chi-squared||||||-2.1|0.329
71120637|NCT00089986|141747030|SUPERIORITY_OR_OTHER||Rate Difference|-4.4||||0.879|ONE_SIDED|90.0|-9.4||||Chi-squared||||||-9.4|0.879
71120638|NCT03995680|141747042|SUPERIORITY||Difference in Egg Reduction Rate (%)|2.3|||||TWO_SIDED|95.0|-7.8|12.6|||Regression, Logistic|Adjusted for age, sex, weight and baseline hookworm infection intensity (light or moderate/heavy)||The 95% confidence intervals (CIs) for ERRs and the difference between ERRs were estimated via bootstrap resampling. Superiority was claimed if the 95% confidence interval of the difference in ERRs did not include unity. Logistic regression models were used to assess efficacy in terms of CRs. In a subsequent analysis an adjusted logistic regression (adjustment for age, sex, weight and baseline infection intensity) was performed.||12.6|-7.8|
71120639|NCT02437305|141747052|SUPERIORITY_OR_OTHER|||||||0.048||||||P-value compares the increase in skin self-exams from pre-intervention to 2-months follow-up between the 2 groups.|McNemar|||||||0.048
71120640|NCT02437305|141747053|SUPERIORITY_OR_OTHER||||||>|0.5||||||P-value compares the increase in knowledge from pre-intervention to 2-months follow-up between the 2 groups.|McNemar|||||||>0.50
71120641|NCT01071200|141747075|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Wilcoxon two sample test|||Change at hCG day : Wilcoxon two sample test was used to calculate p-value.||||0.07
70855123|NCT02880956|141198375|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.164||0.663|TWO_SIDED|95.0|-0.394|0.251||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.251|-0.394|0.663
71120642|NCT01527513|141747088|NON_INFERIORITY_OR_EQUIVALENCE|"A 121ms non-inferiority margin was selected based on a previous study with Cognitive Drug Research (CDR) system comparing newly diagnosed patients to a healthy normative sample.~Assuming a Standard Deviation (SD) of 202.3 for the Power of Attention score, a total of 102 patients in the PP population would provide 80% power to reject the null hypothesis that the mean increase from baseline Power of Attention was at least 121 ms smaller in the placebo group."|Mean Difference (Final Values)|33.2001||||0.7|TWO_SIDED|95.0|-137.593|203.993|||95% CI lower bound vs non-inf margin|||||203.993|-137.593|0.700
71120643|NCT01527513|141747089|NON_INFERIORITY_OR_EQUIVALENCE|"A 121ms non-inferiority margin was selected based on a previous study with Cognitive Drug Research (CDR) system comparing newly diagnosed patients to a healthy normative sample.~Assuming a Standard Deviation (SD) of 202.3 for the Power of Attention score, a total of 102 patients in the PP population would provide 80% power to reject the null hypothesis that the mean increase from baseline Power of Attention was at least 121 ms smaller in the placebo group."|95% CI lower bound vs non-inf margin|33.2001|||<|0.7|TWO_SIDED|95.0|-137.593|203.993|||ANCOVA||The predefined non-inferiority margin was -121ms.|||203.993|-137.593|<0.700
71120644|NCT04465877|141747094|SUPERIORITY||Mean Difference (Final Values)|-2.12||||0.956|TWO_SIDED|95.0|-79.67|75.42|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 5 mg and placebo on Day 1||75.42|-79.67|0.956
71120645|NCT04465877|141747094|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.995|TWO_SIDED|95.0|-105.41|106.07|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 5 mg and placebo on Day 14||106.07|-105.41|0.995
71120646|NCT04465877|141747094|SUPERIORITY||Mean Difference (Final Values)|-59.35||||0.366|TWO_SIDED|95.0|-191.15|72.45|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 5 mg and placebo on Day 28||72.45|-191.15|0.366
71120647|NCT04465877|141747094|SUPERIORITY||Mean Difference (Final Values)|-100.02||||0.016|TWO_SIDED|95.0|-179.96|-20.08|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 10 mg and placebo on Day 1||-20.08|-179.96|0.016
71120648|NCT04465877|141747094|SUPERIORITY||Mean Difference (Final Values)|-137.85||||0.014|TWO_SIDED|95.0|-245.28|-30.43|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 10 mg and placebo on Day 14||-30.43|-245.28|0.014
71120649|NCT04465877|141747094|SUPERIORITY||Mean Difference (Final Values)|-229.04||||0.001|TWO_SIDED|95.0|-362.17|-95.91|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 10 mg and placebo on Day 28||-95.91|-362.17|0.001
70855124|NCT02880956|141198375|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.27|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855125|NCT02880956|141198375|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.193||0.866|TWO_SIDED|95.0|-0.413|0.348||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.348|-0.413|0.866
71120650|NCT04465877|141747094|SUPERIORITY||Mean Difference (Final Values)|-89.98||||0.025|TWO_SIDED|95.0|-167.62|-12.33|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 20 mg and placebo on Day 1||-12.33|-167.62|0.025
71120651|NCT04465877|141747094|SUPERIORITY||Mean Difference (Final Values)|-222.02|||<|0.001|TWO_SIDED|95.0|-326.54|-117.51|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 20 mg and placebo on Day 14||-117.51|-326.54|<0.001
71120652|NCT04465877|141747094|SUPERIORITY||Mean Difference (Final Values)|-248.82|||<|0.001|TWO_SIDED|95.0|-379.35|-118.28|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 20 mg and placebo on Day 28||-118.28|-379.35|<0.001
70954261|NCT00688870|141411079|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Tenderness - Any, Fisher exact test was used to calculate p-value.||||>0.99
71120653|NCT04962230|141747096|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir coadministered with carbamazepine was the Test treatment.|specify in comments|56.82||||0.05|TWO_SIDED|90.0|47.04|68.62|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of adjusted geometric means 2.90% CI for the ratios"|||68.62|47.04|0.05
71120654|NCT04962230|141747097|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir coadministered with carbamazepine was the Test treatment.|Specified in comments|44.5||||0.05|TWO_SIDED|90.0|33.77|58.65|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of adjusted geometric means 2.90% CI for the ratios"|||58.65|33.77|0.05
71120655|NCT04962230|141747098|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir coadministered with carbamazepine was the Test treatment.|Specified in comments|25.59||||0.05|TWO_SIDED|90.0|18.76|34.91|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of adjusted geometric means 2.90% CI for the ratios"|||34.91|18.76|0.05
71120656|NCT04962230|141747099|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir coadministered with carbamazepine was the Test treatment.|Specified in comments|16.57||||0.05|TWO_SIDED|90.0|13.32|20.6|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of adjusted geometric means 2.90% CI for the ratios"|||20.60|13.32|0.05
71120657|NCT04962230|141747105|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir coadministered with carbamazepine was the Test treatment.|Specified in comments|44.59||||0.05|TWO_SIDED|90.0|33.99|58.5|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of adjusted geometric means 2.90% CI for the ratios"|||58.50|33.99|0.05
71120658|NCT04962230|141747110|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir coadministered with carbamazepine was the Test treatment.|Specified in comments|12.92||||0.05|TWO_SIDED|90.0|9.28|17.99|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of adjusted geometric means 2.90% CI for the ratios"|||17.99|9.28|0.05
71120659|NCT04346108|141747152|SUPERIORITY||Poisson Estimate|1.65|||||TWO_SIDED|95.0|0.73|3.15||||||||3.15|0.73|
71120660|NCT04346108|141747152|SUPERIORITY||Poisson Estimate|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.00|0.00|
71120661|NCT04346108|141747152|SUPERIORITY||Poisson Estimate|2.48|||||TWO_SIDED|95.0|1.34|4.13||||||||4.13|1.34|
71120662|NCT04346108|141747153|SUPERIORITY||Poisson Estimate|2.6|||||TWO_SIDED|95.0|1.02|5.3||||||||5.30|1.02|
70855126|NCT02880956|141198375|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|1.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71120663|NCT04346108|141747153|SUPERIORITY||Poisson Estimate|9.82|||||TWO_SIDED|95.0|2.82|23.82||||||||23.82|2.82|
71120664|NCT04346108|141747153|SUPERIORITY||Poisson Estimate|2.87|||||TWO_SIDED|95.0|1.37|5.18||||||||5.18|1.37|
71120665|NCT04346108|141747154|SUPERIORITY||Poisson Estimate|4.01||||||95.0|1.46|8.54||||||||8.54|1.46|
71120666|NCT04346108|141747154|SUPERIORITY||Poisson Estimate|3.07|||||TWO_SIDED|95.0|0.37|10.74||||||||10.74|0.37|
71120667|NCT04346108|141747154|SUPERIORITY||Poisson Estimate|5.87|||||TWO_SIDED|95.0|2.32|11.93||||||||11.93|2.32|
70954262|NCT00688870|141411079|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Tenderness - Significant, Fisher exact test was used to calculate p-value.||||>0.99
71120668|NCT04346108|141747155|SUPERIORITY||Poisson Estimate|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.0|0.0|
71120669|NCT04346108|141747155|SUPERIORITY||Poisson Estimate|0.13|||||TWO_SIDED|95.0|0.03|0.35||||||||0.35|0.03|
71120670|NCT04346108|141747155|SUPERIORITY||Poisson Estimate|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.00|0.00|
71120671|NCT04346108|141747156|SUPERIORITY||Poisson Estimate|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.00|0.00|
71120672|NCT04346108|141747156|SUPERIORITY||Poisson Estimate|1.04|||||TWO_SIDED|95.0|0.25|2.76||||||||2.76|0.25|
71120673|NCT04346108|141747157|SUPERIORITY||Poisson Estimate|1.18|||||TWO_SIDED|95.0|0.38|2.68||||||||2.68|0.38|
71120674|NCT04346108|141747157|SUPERIORITY||Poisson Estimate|2.35|||||TWO_SIDED|95.0|0.91|4.82||||||||4.82|0.91|
71120675|NCT04346108|141747157|SUPERIORITY||Poisson Estimate|0.61|||||TWO_SIDED|95.0|0.07|2.15||||||||2.15|0.07|
71120676|NCT02159118|141747169|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
71120677|NCT02159118|141747170|SUPERIORITY_OR_OTHER|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
71120678|NCT02159118|141747171|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71120679|NCT02159118|141747172|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
71120680|NCT02159118|141747173|SUPERIORITY_OR_OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
71120681|NCT02159118|141747174|SUPERIORITY_OR_OTHER|||||||0.93|||||||Wilcoxon (Mann-Whitney)|||||||0.93
71120682|NCT02159118|141747175|SUPERIORITY_OR_OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
71120683|NCT02159118|141747176|SUPERIORITY_OR_OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||0.51
71120684|NCT02159118|141747177|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
71120685|NCT00386477|141747178|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.55||||0.11||95.0|0.26|1.11|||Chi-squared, Corrected|||||1.11|0.26|0.11
71120686|NCT02446418|141747179|NON_INFERIORITY|Non-inferiority of fixed combination FF/VI to usual ICS/LABA in inhalation powder was assessed assuming a non-inferiority margin of -1.5.|Mean Difference (Net)|0.8||||0.033|TWO_SIDED|95.0|0.1|1.5|||Mixed model repeated measures (MMRM)||||The analysis method was an MMRM adjusted for randomized treatment, visit (Week 6 and Week 12), Baseline ACT total score, randomized treatment-by-visit interaction, Baseline ACT total score-by-visit interaction, gender, age, country and participant fitted as a random factor. The Restricted Maximum Likelihood (REML) estimation approach was used with a default covariance structure of unstructured.|1.5|0.1|0.033
71120687|NCT02446418|141747180|NON_INFERIORITY|Non-inferiority of fixed combination FF/VI to usual ICS/LABA in inhalation powder was assessed assuming a non-inferiority margin of -1.5.|Mean Difference (Net)|0.4||||0.224|TWO_SIDED|95.0|-0.3|1.1|||Mixed model repeated measures (MMRM)||||The analysis method was an MMRM adjusted for randomized treatment, visit (Week 6, Week 12, Week 18 and Week 24), Baseline ACT total score, randomized treatment-by-visit interaction, Baseline ACT total score-by visit interaction, gender, age, country and participant fitted as a random factor. The REML estimation approach was used with a default covariance structure of unstructured.|1.1|-0.3|0.224
70943930|NCT02630706|141387826|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-AHA status at Screening (metformin alone, metformin + another AHA), country (China, other), baseline eGFR (continuous) and the interaction of time by treatment.|Difference in the LS Means vs. Placebo|-0.8|||<|0.001|TWO_SIDED|95.0|-0.97|-0.63|||cLDA|||The primary hypothesis of the study was the mean change from baseline in HbA1c for 5 mg ertugliflozin is greater than that for placebo.||-0.63|-0.97|<0.001
71120688|NCT02446418|141747181|SUPERIORITY||Adjusted Odds Ratio|1.11||||0.82|TWO_SIDED|95.0|0.47|2.62|||Regression, Logistic|||Week 12|The analysis method was logistic regression adjusted for randomized treatment, correct use of inhaler device at Baseline, gender, age and country.|2.62|0.47|0.820
71120689|NCT02446418|141747181|SUPERIORITY||Adjusted Odds Ratio|1.41||||0.566|TWO_SIDED|95.0|0.43|4.6|||Regression, Logistic|||Week 24|The analysis method was logistic regression adjusted for randomized treatment, correct use of inhaler device at Baseline, gender, age and country.|4.60|0.43|0.566
71120690|NCT02014480|141747187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108|||<|0.001|TWO_SIDED|95.0|0.065|0.151||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to UMEC=responders to UMEC or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 milliliters (mL) at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.151|0.065|<0.001
71120691|NCT02014480|141747187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.107|||<|0.001|TWO_SIDED|95.0|0.064|0.149||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to UMEC=responders to UMEC or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 mL at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.149|0.064|<0.001
71120692|NCT02014480|141747187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|||<|0.001|TWO_SIDED|95.0|0.086|0.171||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to VI=responders to VI or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 mL at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.171|0.086|<0.001
71120693|NCT02014480|141747187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|||<|0.001|TWO_SIDED|95.0|0.04|0.125||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to VI=responders to VI or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 mL at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.125|0.040|<0.001
71120694|NCT02014480|141747187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|||<|0.001|TWO_SIDED|95.0|0.036|0.12||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to Neither=responders to neither UMEC nor VI, as defined by a participant with at least one FEV1 assessment over 0-6 hours post-dose on Day 1 but no increase from Baseline of \>=12% and 200 mL at any assessment(s).|||0.120|0.036|<0.001
71120695|NCT02014480|141747187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057||||0.008|TWO_SIDED|95.0|0.015|0.099||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to Neither=responders to neither UMEC nor VI, as defined by a participant with at least one FEV1 assessment over 0-6 hours post-dose on Day 1 but no increase from Baseline of \>=12% and 200 mL at any assessment(s).|||0.099|0.015|0.008
71120696|NCT01865812|141747193|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.38|||||TWO_SIDED|95.0|-0.51|-0.24||||||||-0.24|-0.51|
71120697|NCT01865812|141747194|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.44|||||TWO_SIDED|95.0|-0.63|-0.25||||||||-0.25|-0.63|
71120698|NCT01865812|141747195|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.06|||||TWO_SIDED|95.0|-1.58|1.46||||||||1.46|-1.58|
71120699|NCT01865812|141747246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.852|||||||ANCOVA|||||||0.852
71120700|NCT01865812|141747247|SUPERIORITY_OR_OTHER_LEGACY|||||||0.549|||||||ANCOVA|||||||0.549
71120701|NCT01865812|141747248|SUPERIORITY_OR_OTHER_LEGACY|||||||0.912|||||||ANCOVA|||||||0.912
71120702|NCT01414205|141747250|SUPERIORITY_OR_OTHER||Difference (Hauck-Anderson)|17.89||||0.0779|TWO_SIDED|95.0|-4.95|40.72|||Cochran-Mantel-Haenszel|P-values based on stratified Cochran-Mantel-Haenszel test by the randomization stratification factors as supportive analyses.||||40.72|-4.95|0.0779
71120703|NCT01854632|141747265|SUPERIORITY_OR_OTHER|||||||0.996|TWO_SIDED||||||Log Rank|||||||0.996
71120704|NCT01819129|141747313|NON_INFERIORITY_OR_EQUIVALENCE|The assessment was done by comparing the difference of faster aspart vs. NovoRapid®/NovoLog® in change from baseline in HbA1c after 26 weeks of randomized treatment to a non-inferiority limit of 0.4%.|Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.15|0.1|||||The estimated parameter i.e mean difference is the estimated treatment difference for Faster aspart vs. NovoRapid (Faster aspart - NovoRapid).|Change from baseline in HbA1c is analysed using a mixed-effect model for repeated measurements including changes from baseline in HbA1c at visit 14, 18, 22, 26, 30 and 36. The model includes treatment, region and continuous glucose monitoring (CGM) strata as fixed effects, subject as random effect, HbA1c at baseline as covariate and interaction between all fixed effects and visit, and between the covariate and visit.||0.10|-0.15|
71120705|NCT02836873|141747317|SUPERIORITY||Difference of LS Means|-0.28||||0.0026|TWO_SIDED|95.0|-0.46|-0.1|||Mixed-effects repeated measures|Region, screening anti-diabetic treatment, baseline eGFR, treatment, visit, treatment-by-visit and baseline HbA1c value as fixed effect covariates.||This is a mixed-effects repeated measures analysis including region, screening anti-diabetic treatment regimen, baseline eGFR, treatment, visit, treatment-by-visit interaction and baseline HbA1c as a fixed effect covariate. Data from Weeks 6, 12, and 24 are used in the model.||-0.10|-0.46|0.0026
71120706|NCT02836873|141747318|SUPERIORITY||Difference of LS Means|-1.76|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.03|||Mixed-effects repeated measures|Region, screening anti-diabetic treatment, baseline eGFR, treatment, visit, treatment-by-visit and baseline HbA1c value as fixed effect covariates.||||-1.03|-2.50|< 0.0001
70855127|NCT02880956|141198375|SUPERIORITY||LS Mean of Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.191||0.471|TWO_SIDED|95.0|-0.514|0.238||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.238|-0.514|0.471
70943931|NCT02630706|141387827|SUPERIORITY||Difference in the LSM vs. placebo|-0.68|||<|0.001|TWO_SIDED|95.0|-0.86|-0.5||cLDA model with fixed effects for treatment, time, anti-AHA status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment.|cLDA|||||-0.50|-0.86|<0.001
70943932|NCT02630706|141387827|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-AHA status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment.|Difference in the LS Means vs. Placebo|-0.76|||<|0.001|TWO_SIDED|95.0|-0.95|-0.58|||cLDA|||||-0.58|-0.95|<0.001
70943933|NCT02630706|141387828|OTHER||Difference in % vs. Placebo|-6.0|||||TWO_SIDED|95.0|-16.5|4.6|||||||Miettinen-Nurminen method|4.6|-16.5|
70943934|NCT02630706|141387828|OTHER||Difference in % vs. Placebo|-2.8|||||TWO_SIDED|95.0|-13.3|7.7|||||||Miettinen-Nurminen method|7.7|-13.3|
70943935|NCT02630706|141387829|OTHER||Difference in % vs. Placebo|-8.9|||||TWO_SIDED|95.0|-20.5|3.0|||||||Miettinen-Nurminen method|3.0|-20.5|
71120707|NCT02836873|141747319|SUPERIORITY||Difference of LS Means|-2.63||||0.2035|TWO_SIDED|95.0|-6.7|1.44|||Mixed-effects repeated measures|Region, screening anti-diabetic treatment, baseline eGFR, treatment, visit, treatment-by-visit and baseline HbA1c value as fixed effect covariates.||||1.44|-6.70|0.2035
70855128|NCT02880956|141198375|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|1.24|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855129|NCT02880956|141198375|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.198||0.604|TWO_SIDED|95.0|-0.493|0.287||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.287|-0.493|0.604
70855130|NCT02880956|141198375|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|1.21|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70943936|NCT02630706|141387829|OTHER||Difference in % vs. Placebo|-4.8|||||TWO_SIDED|95.0|-16.5|6.9|||||||Miettinen-Nurminen method|6.9|-16.5|
71120708|NCT02836873|141747320|SUPERIORITY||Difference of LS Means|-0.2||||0.1156|TWO_SIDED|95.0|-0.44|0.05|||Mixed-effects repeated measures|Region, screening anti-diabetic treatment, baseline eGFR, treatment, visit, treatment-by-visit and baseline HbA1c value as fixed effect covariates.||||0.05|-0.44|0.1156
70855131|NCT02880956|141198376|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.069||0.325|TWO_SIDED|95.0|-0.067|0.202||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.202|-0.067|0.325
70855132|NCT02880956|141198376|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|0.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855133|NCT02880956|141198376|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.067||0.51|TWO_SIDED|95.0|-0.177|0.088||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.088|-0.177|0.510
70855134|NCT02880956|141198376|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|0.44|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855135|NCT02880956|141198376|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.069||0.601|TWO_SIDED|95.0|-0.1|0.172||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.172|-0.100|0.601
70855136|NCT02880956|141198376|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|0.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855137|NCT02880956|141198376|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.783|TWO_SIDED|95.0|-0.157|0.119||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.119|-0.157|0.783
70943937|NCT02630706|141387832|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-27.78|||<|0.001|TWO_SIDED|95.0|-33.85|-21.7|||cLDA|||||-21.70|-33.85|<0.001
70943938|NCT02630706|141387832|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-30.4|||<|0.001|TWO_SIDED|95.0|-36.45|-24.35|||cLDA|||||-24.35|-36.45|<0.001
70943939|NCT02630706|141387833|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-26.21|||<|0.001|TWO_SIDED|95.0|-32.41|-20.01|||cLDA|||||-20.01|-32.41|<0.001
70943940|NCT02630706|141387833|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-28.55|||<|0.001|TWO_SIDED|95.0|-34.67|-22.43|||cLDA|||||-22.43|-34.67|<0.001
70855138|NCT02880956|141198376|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|0.52|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855139|NCT02880956|141198376|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.068||0.646|TWO_SIDED|95.0|-0.165|0.103||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.103|-0.165|0.646
70855140|NCT02880956|141198376|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|0.48|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855141|NCT02880956|141198376|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.209|TWO_SIDED|95.0|-0.226|0.05||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.050|-0.226|0.209
70855142|NCT02880956|141198376|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|0.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855143|NCT02880956|141198376|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.091||0.454|TWO_SIDED|95.0|-0.246|0.11||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.110|-0.246|0.454
71120709|NCT02836873|141747321|SUPERIORITY||Difference of LS Means|-0.37||||0.0078|TWO_SIDED|95.0|-0.65|-0.1|||Mixed-effects repeated measures|Region, screening anti-diabetic treatment, baseline eGFR, treatment, visit, treatment-by-visit and baseline HbA1c value as fixed effect covariates.||||-0.10|-0.65|0.0078
71120710|NCT02214225|141747335|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H1N1)|0.92|||||TWO_SIDED|95.0|0.87|0.98||||||For A/H1N1 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.98|0.87|
71120711|NCT02214225|141747335|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H3N2)|0.93|||||TWO_SIDED|95.0|0.88|0.98||||||For A/H3N2 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.98|0.88|
70855144|NCT02880956|141198376|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|0.66|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855145|NCT02880956|141198376|SUPERIORITY||LS Mean of Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.089||0.141|TWO_SIDED|95.0|-0.306|0.043||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.043|-0.306|0.141
70855146|NCT02880956|141198376|SUPERIORITY||Effect size/pooled SD|0.23|STANDARD_DEVIATION|0.58|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855147|NCT02880956|141198376|SUPERIORITY||LS Mean of Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.107|TWO_SIDED|95.0|-0.323|0.031||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.031|-0.323|0.107
70855148|NCT02880956|141198376|SUPERIORITY||Effect size/pooled SD|0.24|STANDARD_DEVIATION|0.59|||TWO_SIDED|||||||||Week 72||||
70855149|NCT02880956|141198376|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.121||0.961|TWO_SIDED|95.0|-0.243|0.232||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.232|-0.243|0.961
70855150|NCT02880956|141198376|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|0.79|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855151|NCT02880956|141198376|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.118||0.618|TWO_SIDED|95.0|-0.29|0.173||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.173|-0.290|0.618
70855152|NCT02880956|141198376|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|0.77|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855153|NCT02880956|141198376|SUPERIORITY||LS Mean of Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.121||0.227|TWO_SIDED|95.0|-0.385|0.092||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.092|-0.385|0.227
70855154|NCT02880956|141198376|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|0.79|||TWO_SIDED|||||||||Week 96||||
70855155|NCT02880956|141198377|SUPERIORITY||LS Mean of Difference|0.34|STANDARD_ERROR_OF_MEAN|0.18||0.056|TWO_SIDED|95.0|-0.009|0.697||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.697|-0.009|0.056
70943941|NCT02630706|141387834|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-2.0|||<|0.001|TWO_SIDED|95.0|-2.51|-1.5|||cLDA|||||-1.50|-2.51|<0.001
70855156|NCT02880956|141198377|SUPERIORITY||Effect size/pooled SD|-0.23|STANDARD_DEVIATION|1.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855157|NCT02880956|141198377|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.177||0.997|TWO_SIDED|95.0|-0.348|0.349||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.349|-0.348|0.997
70855158|NCT02880956|141198377|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|1.34|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855159|NCT02880956|141198377|SUPERIORITY||LS Mean of Difference|0.41|STANDARD_ERROR_OF_MEAN|0.182||0.023|TWO_SIDED|95.0|0.056|0.772||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.772|0.056|0.023
70855160|NCT02880956|141198377|SUPERIORITY||Effect size/pooled SD|-0.3|STANDARD_DEVIATION|1.36|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855161|NCT02880956|141198377|SUPERIORITY||LS Mean of Difference|0.14|STANDARD_ERROR_OF_MEAN|0.212||0.502|TWO_SIDED|95.0|-0.274|0.558||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.558|-0.274|0.502
70855162|NCT02880956|141198377|SUPERIORITY||Effect size/pooled SD|-0.09|STANDARD_DEVIATION|1.58|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855163|NCT02880956|141198377|SUPERIORITY||LS Mean of Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.206||0.379|TWO_SIDED|95.0|-0.587|0.224||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.224|-0.587|0.379
70855164|NCT02880956|141198377|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|1.61|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855165|NCT02880956|141198377|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.212||0.916|TWO_SIDED|95.0|-0.439|0.394||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.394|-0.439|0.916
70855166|NCT02880956|141198377|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|1.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855167|NCT02880956|141198377|SUPERIORITY||LS Mean of Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.238||0.487|TWO_SIDED|95.0|-0.633|0.302||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.302|-0.633|0.487
70855168|NCT02880956|141198377|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|1.7|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855169|NCT02880956|141198377|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.235||0.963|TWO_SIDED|95.0|-0.451|0.473||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.473|-0.451|0.963
70855170|NCT02880956|141198377|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|1.66|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855171|NCT02880956|141198377|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.238||0.856|TWO_SIDED|95.0|-0.424|0.51||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.510|-0.424|0.856
70855172|NCT02880956|141198377|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|1.71|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855173|NCT02880956|141198377|SUPERIORITY||LS Mean of Difference|0.2|STANDARD_ERROR_OF_MEAN|0.277||0.463|TWO_SIDED|95.0|-0.341|0.748||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.748|-0.341|0.463
70855174|NCT02880956|141198377|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|1.87|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70954263|NCT00688870|141411079|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0|||||Fisher Exact|||For Swelling - Any, Fisher exact test was used to calculate p-value.||||0.044
70954264|NCT00688870|141411079|SUPERIORITY_OR_OTHER_LEGACY|||||||0.076||95.0|||||Fisher Exact|||For Swelling - Mild, Fisher exact test was used to calculate p-value.||||0.076
70943942|NCT02630706|141387834|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-1.78|||<|0.001|TWO_SIDED|95.0|-2.28|-1.28|||cLDA|||||-1.28|-2.28|<0.001
70943943|NCT02630706|141387835|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-2.05|||<|0.001|TWO_SIDED|95.0|-2.63|-1.21|||cLDA|||||-1.21|-2.63|<0.001
70855175|NCT02880956|141198377|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.273||0.943|TWO_SIDED|95.0|-0.518|0.557||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.557|-0.518|0.943
70943944|NCT02630706|141387835|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-1.79|||<|0.001|TWO_SIDED|95.0|-2.36|-1.21|||cLDA|||||-1.21|-2.36|<0.001
70943945|NCT02630706|141387836|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|4.56|||<|0.001|TWO_SIDED|95.0|2.49|8.35|||Logistic regression model|||||8.35|2.49|<0.001
71120712|NCT02214225|141747335|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/YAM)|0.87|||||TWO_SIDED|95.0|0.81|0.93||||||For B/Yamagata strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.93|0.81|
71120713|NCT02214225|141747335|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/VIC)|0.94|||||TWO_SIDED|95.0|0.86|1.01||||||For B/Victoria strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||1.01|0.86|
71120714|NCT02214225|141747336|NON_INFERIORITY_OR_EQUIVALENCE|For A/H1N1. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H1N1)|-1.1|||||TWO_SIDED|95.0|-4.4|2.2||||||||2.2|-4.4|
71120715|NCT02214225|141747336|NON_INFERIORITY_OR_EQUIVALENCE|For A/H3N2. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H3N2)|-1.7|||||TWO_SIDED|95.0|-5.0|1.6||||||||1.6|-5.0|
71120716|NCT02214225|141747336|NON_INFERIORITY_OR_EQUIVALENCE|For B/Yamagata. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/YAM)|-3.2|||||TWO_SIDED|95.0|-7.0|0.5||||||||0.5|-7.0|
70954265|NCT00688870|141411079|SUPERIORITY_OR_OTHER_LEGACY|||||||0.496||95.0|||||Fisher Exact|||For Swelling - Moderate, Fisher exact test was used to calculate p-value.||||0.496
70954266|NCT00688870|141411079|SUPERIORITY_OR_OTHER_LEGACY|||||||0.361||95.0|||||Fisher Exact|||For Redness - Any, Fisher exact test was used to calculate p-value.||||0.361
70855176|NCT02880956|141198377|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|1.93|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71120717|NCT02214225|141747336|NON_INFERIORITY_OR_EQUIVALENCE|For B/Victoria. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/VIC)|-1.6|||||TWO_SIDED|95.0|-5.6|2.4||||||||2.4|-5.6|
71120718|NCT02214225|141747337|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H1N1)|0.93|||||TWO_SIDED|95.0|0.85|1.02||||||For A/H1N1 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||1.02|0.85|
71120719|NCT02214225|141747337|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H3N2)|0.91|||||TWO_SIDED|95.0|0.83|0.99||||||For A/H3N2 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.99|0.83|
71120720|NCT02214225|141747337|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/YAM)|0.86|||||TWO_SIDED|95.0|0.76|0.97||||||For B/YAM strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.97|0.76|
71120721|NCT02214225|141747337|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/VIC)|0.86|||||TWO_SIDED|95.0|0.76|0.98||||||For B/VIC strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.98|0.76|
71120722|NCT02214225|141747337|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H1N1)|0.95|||||TWO_SIDED|95.0|0.88|1.02||||||For A/H1N1 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||1.02|0.88|
71120723|NCT02214225|141747337|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H3N2)|0.95|||||TWO_SIDED|95.0|0.89|1.02||||||For A/H3N2 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||1.02|0.89|
71120724|NCT02214225|141747337|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/YAM)|0.9|||||TWO_SIDED|95.0|0.84|0.97||||||For B/YAM strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.97|0.84|
71120725|NCT02214225|141747337|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/VIC)|1.03|||||TWO_SIDED|95.0|0.94|1.14||||||For B/VIC strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||1.14|0.94|
71120726|NCT02214225|141747338|NON_INFERIORITY_OR_EQUIVALENCE|For A/H1N1. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H1N1)|-2.1|||||TWO_SIDED|95.0|-6.9|2.6||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||2.6|-6.9|
71120727|NCT02214225|141747338|NON_INFERIORITY_OR_EQUIVALENCE|For A/H3N2. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H3N2)|-4.6|||||TWO_SIDED|95.0|-9.3|0.2||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||0.2|-9.3|
71120728|NCT02214225|141747338|NON_INFERIORITY_OR_EQUIVALENCE|For B/YAM. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/YAM)|-4.5|||||TWO_SIDED|95.0|-10.3|1.3||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||1.3|-10.3|
70954267|NCT00688870|141411079|SUPERIORITY_OR_OTHER_LEGACY|||||||0.635||95.0|||||Fisher Exact|||For Redness - Mild, Fisher exact test was used to calculate p-value.||||0.635
71081242|NCT01763827|141669163|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.77|STANDARD_ERROR_OF_MEAN|2.29|<|0.001|TWO_SIDED|95.0|-57.28|-48.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-48.26|-57.28|<0.001
71081243|NCT01763827|141669163|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.76|STANDARD_ERROR_OF_MEAN|2.13|<|0.001|TWO_SIDED|95.0|-39.95|-31.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-31.57|-39.95|<0.001
71081244|NCT01763827|141669163|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.97|STANDARD_ERROR_OF_MEAN|2.29|<|0.001|TWO_SIDED|95.0|-38.48|-29.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-29.45|-38.48|<0.001
71081245|NCT01763827|141669164|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-18.48|||<|0.001|TWO_SIDED|95.0|-25.28|-11.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-11.68|-25.28|<0.001
71081246|NCT01763827|141669164|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-19.24|||<|0.001|TWO_SIDED|95.0|-23.2|-15.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-15.28|-23.20|<0.001
71120729|NCT02214225|141747338|NON_INFERIORITY_OR_EQUIVALENCE|For B/VIC. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/VIC)|-4.6|||||TWO_SIDED|95.0|-10.5|1.2||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||1.2|-10.5|
71120730|NCT02214225|141747338|NON_INFERIORITY_OR_EQUIVALENCE|For A/H1N1. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H1N1)|-0.2|||||TWO_SIDED|95.0|-4.4|4.0||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||4.0|-4.4|
70855177|NCT02880956|141198377|SUPERIORITY||LS Mean of Difference|0.74|STANDARD_ERROR_OF_MEAN|0.281||0.009|TWO_SIDED|95.0|0.191|1.295||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||1.295|0.191|0.009
71120731|NCT02214225|141747338|NON_INFERIORITY_OR_EQUIVALENCE|For A/H3N2. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H3N2)|1.1|||||TWO_SIDED|95.0|-3.1|5.2||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||5.2|-3.1|
71120732|NCT02214225|141747338|NON_INFERIORITY_OR_EQUIVALENCE|For B/YAM. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/YAM)|-2.2|||||TWO_SIDED|95.0|-6.3|2.0||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||2.0|-6.3|
71120733|NCT02214225|141747338|NON_INFERIORITY_OR_EQUIVALENCE|For B/VIC. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/VIC)|1.2|||||TWO_SIDED|95.0|-3.7|6.2||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||6.2|-3.7|
71081247|NCT01763827|141669164|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-18.37|||<|0.001|TWO_SIDED|95.0|-24.39|-12.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-12.35|-24.39|<0.001
71081248|NCT01763827|141669164|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-17.15|||<|0.001|TWO_SIDED|95.0|-23.23|-11.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-11.08|-23.23|<0.001
71081249|NCT01763827|141669165|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-20.41|||<|0.001|TWO_SIDED|95.0|-27.76|-13.06||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-13.06|-27.76|<0.001
71081250|NCT01763827|141669165|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-17.82|||<|0.001|TWO_SIDED|95.0|-24.51|-11.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-11.12|-24.51|<0.001
71081251|NCT01763827|141669165|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-20.41|||<|0.001|TWO_SIDED|95.0|-28.13|-12.69||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-12.69|-28.13|<0.001
70855178|NCT02880956|141198377|SUPERIORITY||Effect size/pooled SD|-0.38|STANDARD_DEVIATION|1.97|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855179|NCT02880956|141198378|SUPERIORITY||LS Mean of Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.138||0.325|TWO_SIDED|95.0|-0.408|0.136||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.136|-0.408|0.325
70855180|NCT02880956|141198378|SUPERIORITY||Effect size/pooled SD|0.13|STANDARD_DEVIATION|1.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855181|NCT02880956|141198378|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.137||0.966|TWO_SIDED|95.0|-0.274|0.263||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.263|-0.274|0.966
70855182|NCT02880956|141198378|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|1.11|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855183|NCT02880956|141198378|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.14||0.695|TWO_SIDED|95.0|-0.33|0.22||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.220|-0.330|0.695
70855184|NCT02880956|141198378|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|1.09|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855185|NCT02880956|141198378|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.145||0.662|TWO_SIDED|95.0|-0.348|0.221||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.221|-0.348|0.662
70855186|NCT02880956|141198378|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.01|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855187|NCT02880956|141198378|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.141||0.849|TWO_SIDED|95.0|-0.25|0.304||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.304|-0.250|0.849
70855188|NCT02880956|141198378|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|1.08|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855189|NCT02880956|141198378|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.145||0.995|TWO_SIDED|95.0|-0.286|0.284||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.284|-0.286|0.995
70855190|NCT02880956|141198378|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|0.96|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855191|NCT02880956|141198378|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.161||0.707|TWO_SIDED|95.0|-0.256|0.378||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.378|-0.256|0.707
70855192|NCT02880956|141198378|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|1.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855193|NCT02880956|141198378|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.159||0.901|TWO_SIDED|95.0|-0.294|0.333||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.333|-0.294|0.901
70855194|NCT02880956|141198378|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|1.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855195|NCT02880956|141198378|SUPERIORITY||LS Mean of Difference|0.12|STANDARD_ERROR_OF_MEAN|0.161||0.451|TWO_SIDED|95.0|-0.195|0.439||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.439|-0.195|0.451
70855196|NCT02880956|141198378|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|1.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855197|NCT02880956|141198378|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.185||0.722|TWO_SIDED|95.0|-0.429|0.298||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.298|-0.429|0.722
70855198|NCT02880956|141198378|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855199|NCT02880956|141198378|SUPERIORITY||LS Mean of Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.181||0.42|TWO_SIDED|95.0|-0.503|0.21||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.210|-0.503|0.420
70855200|NCT02880956|141198378|SUPERIORITY||Effect size/pooled SD|0.12|STANDARD_DEVIATION|1.21|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855201|NCT02880956|141198378|SUPERIORITY||LS Mean of Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.187||0.498|TWO_SIDED|95.0|-0.495|0.241||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.241|-0.495|0.498
70855202|NCT02880956|141198378|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|1.2|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71120734|NCT02214225|141747339|SUPERIORITY_OR_OTHER||GMT ratio (B/YAM) overall|1.47|||||TWO_SIDED|95.0|1.38|1.57|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT ratio was greater than 1.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.||1.57|1.38|
71120735|NCT02214225|141747339|SUPERIORITY_OR_OTHER||GMT ratio (B/VIC) overall|1.57|||||TWO_SIDED|95.0|1.45|1.7|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT ratio was greater than 1.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.||1.70|1.45|
71120736|NCT02214225|141747339|SUPERIORITY_OR_OTHER||GMT ratio (B/YAM) 18 through 64 years|1.67|||||TWO_SIDED|95.0|1.5|1.87|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT was greater than 1|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.||1.87|1.50|
71120737|NCT02214225|141747339|SUPERIORITY_OR_OTHER||GMT ratio (B/VIC) 18 through 64 years|1.76|||||TWO_SIDED|95.0|1.55|2.01|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT was greater than 1|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.||2.01|1.55|
71120738|NCT02214225|141747339|SUPERIORITY_OR_OTHER||GMT ratio (B/YAM) ≥ 65 years|1.3|||||TWO_SIDED|95.0|1.21|1.4|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT was greater than 1|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.||1.40|1.21|
71120739|NCT02214225|141747339|SUPERIORITY_OR_OTHER||GMT ratio (B/VIC) ≥ 65 years|1.38|||||TWO_SIDED|95.0|1.27|1.51|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT was greater than 1|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.||1.51|1.27|
71120740|NCT02214225|141747340|SUPERIORITY_OR_OTHER||Difference in SCR (B/YAM) overall|15.3|||||TWO_SIDED|95.0|12.1|18.6|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was \> 0.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage||18.6|12.1|
71120741|NCT02214225|141747340|SUPERIORITY_OR_OTHER||Difference in SCR (B/VIC) overall|20.1|||||TWO_SIDED|95.0|16.5|23.6|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was \> 0.|Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage||23.6|16.5|
70855203|NCT02880956|141198379|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.071||0.975|TWO_SIDED|95.0|-0.138|0.142||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.142|-0.138|0.975
70855204|NCT02880956|141198379|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|0.45|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70943946|NCT02630706|141387836|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|4.59|||<|0.001|TWO_SIDED|95.0|2.52|8.36|||Logistic regression model|||||8.36|2.52|<0.001
70943947|NCT02630706|141387837|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|4.49|||<|0.001|TWO_SIDED|95.0|2.32|8.68|||Logistic regression model|||||8.68|2.32|<0.001
70943948|NCT02630706|141387837|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|3.47|||<|0.001|TWO_SIDED|95.0|1.77|6.8|||Logistic regression model|||||6.80|1.77|<0.001
70855205|NCT02880956|141198379|SUPERIORITY||LS Mean of Difference|0.12|STANDARD_ERROR_OF_MEAN|0.07||0.078|TWO_SIDED|95.0|-0.014|0.261||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.261|-0.014|0.078
70943949|NCT02630706|141387838|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-4.09|||<|0.001|TWO_SIDED|95.0|-6.48|-1.69|||cLDA|||||-1.69|-6.48|<0.001
70954268|NCT00688870|141411079|SUPERIORITY_OR_OTHER_LEGACY|||||||0.244||95.0|||||Fisher Exact|||For Redness - Moderate, Fisher exact test was used to calculate p-value.||||0.244
71120742|NCT02214225|141747340|SUPERIORITY_OR_OTHER||Difference in SCR (B/YAM) 18 through 64y|22.9|||||TWO_SIDED|95.0|17.7|28.2|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was \> 0.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage||28.2|17.7|
70855206|NCT02880956|141198379|SUPERIORITY||Effect size/pooled SD|-0.19|STANDARD_DEVIATION|0.66|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855207|NCT02880956|141198379|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.072||0.514|TWO_SIDED|95.0|-0.188|0.094||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.094|-0.188|0.514
70943950|NCT02630706|141387838|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-5.3|||<|0.001|TWO_SIDED|95.0|-7.68|-2.92|||cLDA|||||-2.92|-7.68|<0.001
71120743|NCT02214225|141747340|SUPERIORITY_OR_OTHER||Difference in SCR (B/VIC) 18 through 64y|28.6|||||TWO_SIDED|95.0|23.1|34.1|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was \> 0.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage||34.1|23.1|
70855208|NCT02880956|141198379|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|0.47|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70943951|NCT02630706|141387839|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-2.64||||0.058|TWO_SIDED|95.0|-5.36|0.09|||cLDA|||||0.09|-5.36|0.058
70855209|NCT02880956|141198379|SUPERIORITY||LS Mean of Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.102||0.107|TWO_SIDED|95.0|-0.367|0.036||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.036|-0.367|0.107
70943952|NCT02630706|141387839|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-4.08||||0.003|TWO_SIDED|95.0|-6.78|-1.39|||cLDA|||||-1.39|-6.78|0.003
70943953|NCT02630706|141387840|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-1.4||||0.086|TWO_SIDED|95.0|-3.0|0.2|||cLDA|||||0.20|-3.00|0.086
71120744|NCT02214225|141747340|SUPERIORITY_OR_OTHER||Difference in SCR (B/YAM) ≥ 65 years|8.0|||||TWO_SIDED|95.0|4.3|11.6|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was \> 0.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage||11.6|4.3|
71120745|NCT02214225|141747340|SUPERIORITY_OR_OTHER||Difference in SCR (B/VIC) ≥ 65 years|11.9|||||TWO_SIDED|95.0|7.7|16.0|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was \> 0.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage.||16.0|7.7|
71120746|NCT02648022|141747349|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.91||||0.07|TWO_SIDED|95.0|0.92|9.27|||Regression, Linear|Multivariable Regression Analysis||||9.27|0.92|0.07
71120747|NCT02182440|141747352|SUPERIORITY||Difference in LS means|-16.53|STANDARD_ERROR_OF_MEAN|19.243||0.949|TWO_SIDED|95.0|-62.57|29.5|||ANOVA|||Analysis for Part 1||29.50|-62.57|0.949
71120748|NCT02182440|141747352|SUPERIORITY||Difference in LS means|-4.65|STANDARD_ERROR_OF_MEAN|9.305||0.691|TWO_SIDED|95.0|-23.09|13.8|||ANOVA|||Analysis for Part 2||13.80|-23.09|0.691
71120749|NCT02182440|141747352|SUPERIORITY||Combined p-value|0.896||||0.896|TWO_SIDED||||||Inverse normal method||The p-values from Part 1 (see Statistical Analysis 1) and Part 2 (see Statistical Analysis 2) were combined to an overall p-value using the inverse normal method.|Combination of analysis results from Part 1 (see statistical Analysis 1) and Part 2 (see Statistical analysis 2)||||0.896
71120750|NCT02182440|141747353|SUPERIORITY||Odds Ratio (OR)|1.4||||0.28|TWO_SIDED|95.0|0.8|2.4|||Chi-squared|||||2.4|0.8|0.28
71120751|NCT02182440|141747354|SUPERIORITY||Mean Difference (Net)|0.12||||0.02|TWO_SIDED|95.0|0.02|0.23|||Cochran-Mantel-Haenszel|||||0.23|0.02|0.02
71120752|NCT02182440|141747355|SUPERIORITY||Mean Difference (Net)|0.12||||0.03|TWO_SIDED|95.0|0.01|0.23|||Cochran-Mantel-Haenszel|||||0.23|0.01|0.03
71120753|NCT02182440|141747356|SUPERIORITY||Hazard Ratio (HR)|1.77||||0.045|TWO_SIDED|95.0|1.0|3.1|||Regression, Logistic|||||3.1|1.0|0.045
71120754|NCT02182440|141747357|SUPERIORITY||Hazard Ratio (HR)|1.85||||0.03|TWO_SIDED|95.0|1.06|3.26|||Regression, Logistic|||||3.26|1.06|0.03
71120755|NCT02230761|141747363|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||||||0.020
71120756|NCT02230761|141747364|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
71120757|NCT02230761|141747365|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||||||0.002
71120758|NCT00405964|141747366|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Determined for site. P-value of \<.001 for treatment as well.|ANOVA|||||||<.001
71120759|NCT00405964|141747367|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035||95.0||||Determined for site. Treatment p-value \<.001|ANOVA|||||||0.035
71120760|NCT00405964|141747368|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Same p-value for treatment and site.|ANOVA|||||||<.001
70954269|NCT00688870|141411080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.076||95.0|||||Fisher Exact|||For Tenderness - Any, Fisher exact test was used to calculate p-value.||||0.076
71120761|NCT02863523|141747386|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71120762|NCT02863523|141747387|SUPERIORITY||||||<|0.03|||||||t-test, 2 sided|||||||<0.03
71120763|NCT02863523|141747388|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71120764|NCT00823212|141747418|NON_INFERIORITY_OR_EQUIVALENCE|A 2-group Farrington-Manning test was used to test the 1-sided hypothesis of non-inferiority in differences with a non-inferiority margin of 3.5%. A p value \<0.05 would indicate non-inferiority and correspond to the upper limit of the 1-sided 95% confidence interval of the difference not exceeding 3.5%.|Difference in percent of participants|0.5||||0.001|ONE_SIDED|95.0||2.13|||Farrington-Manning test||The standard error for the difference was estimated according to the Farrington-Manning test.|Study had 89% statistical power to demonstrate non-inferiority for target lesion failure (TLF, accounting for an expected 1-year attrition rate of 5%), assuming a 1-year TLF rate of 5.5% for both stents.||2.13||0.001
71120765|NCT01323270|141747487|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.6|1.5||||||Diphtheria: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.5|-1.6|
71120766|NCT01323270|141747487|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Tetanus: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.1|-1.1|
71120767|NCT01323270|141747487|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|-1.3|||||TWO_SIDED|95.0|-4.7|1.9||||||Pertussis toxoid: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.9|-4.7|
70855210|NCT02880956|141198379|SUPERIORITY||Effect size/pooled SD|0.23|STANDARD_DEVIATION|0.73|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71120768|NCT01323270|141747487|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Pertussis filamentous hemagglutinin: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.1|-1.1|
71120769|NCT01323270|141747487|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Pertussis pertactin: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.1|-1.1|
71120770|NCT01323270|141747487|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|-1.2|||||TWO_SIDED|95.0|-3.6|0.8||||||Pertussis fimbrial agglutinogens types 2+3: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||0.8|-3.6|
71120771|NCT01323270|141747487|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Poliovirus type 1: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.1|-1.1|
71120772|NCT01323270|141747487|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Poliovirus type 2: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.1|-1.1|
71120773|NCT01323270|141747487|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Poliovirus type 3: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.1|-1.1|
71120774|NCT01643850|141747522|SUPERIORITY||Mean Difference (Net)|0.98||||0.915|TWO_SIDED|95.0|0.71|1.36|||ANCOVA|||||1.36|0.71|0.915
71120775|NCT01643850|141747522|SUPERIORITY||Median Difference (Net)|0.78||||0.117|TWO_SIDED|95.0|0.57|1.07|||ANCOVA|||||1.07|0.57|0.117
71120776|NCT01643850|141747522|SUPERIORITY||Mean Difference (Net)|0.69||||0.01|TWO_SIDED|95.0|0.52|0.91|||ANCOVA|||||0.91|0.52|0.010
71120777|NCT03242772|141747552|OTHER|||||||0.2664||||||Significance at \<0.05|95% confidence interval|confidence interval (CI) = -3.5729 - 11.6929|||Presentation of results will include p-values and 95% confidence intervals for the least mean square values at weeks 0, 10, 24 (week 24 is exploratory).|||0.2664
71120778|NCT03242772|141747553|OTHER|||||||0.3721||||||Significance at \<0.05|95% confidence interval|confidence interval (CI) = -17.7698 - 7.2698|||Presentation of results will include p-values and 95% confidence intervals for the least mean square values at weeks 0, 10, 24 (week 24 is exploratory).|||0.3721
71120779|NCT01187004|141747557|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||<|0.05|TWO_SIDED|95.0|||||Regression, Logistic|significant level for inclusion at the univariate analysis was p\<0.05.||Our hypothesis was that mechanical ventilation with large tidal volume might represent a risk factor for acute lung injury in patients undergoing cardiopulmonary bypass.||||<0.05
71120780|NCT01187004|141747558|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.199|||<|0.001|TWO_SIDED|95.0|1.129|1.272|||Wilcoxon (Mann-Whitney)|||||1.272|1.129|<0.001
71120781|NCT03730961|141747566|SUPERIORITY|Drug - placebo|Mean Difference (Net)|-448.0||||0.0021|TWO_SIDED|95.0|-714.0|-183.0|||t-test, 2 sided|||||-183|-714|0.0021
71120782|NCT03730961|141747566|SUPERIORITY|Percent change Drug - placebo|Mean Difference (Net)|-22.1||||0.0222|TWO_SIDED|95.0|-40.7|-3.51|||t-test, 2 sided|||||-3.51|-40.7|0.0222
71120783|NCT03730961|141747567|SUPERIORITY|Drug - placebo, 0-4 hours after furosemide|Mean Difference (Net)|-4.25||||0.0163|TWO_SIDED|95.0|-7.63|-0.876|||t-test, 2 sided|||||-0.876|-7.63|0.0163
71120784|NCT03730961|141747567|SUPERIORITY|Percent change Drug - placebo, 0-4 hours after furosemide|Mean Difference (Net)|-15.0||||0.2018|TWO_SIDED|95.0|-38.8|8.77|||t-test, 2 sided|||||8.77|-38.8|0.2018
71120785|NCT03730961|141747567|SUPERIORITY|Drug - placebo, 0-8 hours after start of infusion|Mean Difference (Net)|-3.61||||0.0526|TWO_SIDED|95.0|-7.27|0.0446|||t-test, 2 sided|||||0.0446|-7.27|0.0526
71120786|NCT03730961|141747567|SUPERIORITY|Percent change Drug - placebo, 0-8 hours after start of infusion|Mean Difference (Net)|-14.9||||0.2076|TWO_SIDED|95.0|-38.8|9.0|||t-test, 2 sided|||||9|-38.8|0.2076
71120787|NCT03730961|141747568|SUPERIORITY|Drug - placebo, 0-4 hours after furosemide|Mean Difference (Net)|0.431||||0.1621|TWO_SIDED|95.0|-0.189|1.05|||t-test, 2 sided|||||1.05|-0.189|0.1621
71120788|NCT03730961|141747568|SUPERIORITY|Percent change Drug - placebo, 0-4 hours after furosemide|Mean Difference (Net)|32.0||||0.0338|TWO_SIDED|95.0|2.72|61.3|||t-test, 2 sided|||||61.3|2.72|0.0338
71120789|NCT03730961|141747568|SUPERIORITY|Drug - placebo, 0-8 hours after start of infusion|Mean Difference (Net)|0.766||||0.06|TWO_SIDED|95.0|-0.0353|1.57|||t-test, 2 sided|||||1.57|-0.0353|0.0600
71120790|NCT03730961|141747568|SUPERIORITY|Percent change Drug - placebo, 0-8 hours after start of infusion|Mean Difference (Net)|33.5||||0.028|TWO_SIDED|95.0|4.02|63.0|||t-test, 2 sided|||||63|4.02|0.0280
71120791|NCT03730961|141747571|SUPERIORITY||Difference between drug and placebo|-4.0|STANDARD_DEVIATION|4.74||||||||||||||||
71120792|NCT03410797|141747583|OTHER|Due to small sample size, nonparametric Wilcoxon signed-rank tests were used to compare VHI-10 before and after therapy.|Median Difference (Net)|7.0||||0.0076|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Descriptive statistics characterized this patient perception measurement.||||.0076
71120793|NCT03410797|141747584|OTHER|Descriptive statistics characterized acoustic and aerodynamic measures, and patient perception measurements.|Median Difference (Final Values)|-1.53||||0.0329|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.0329
71120794|NCT03410797|141747585|OTHER|Descriptive statistics characterized acoustic and aerodynamic measures, and patient perception measurements.|Median Difference (Net)|15.39||||0.0164|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.0164
70943954|NCT02630706|141387840|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-1.42||||0.081|TWO_SIDED|95.0|-3.01|0.17|||cLDA|||||0.17|-3.01|0.081
70943955|NCT02630706|141387841|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-0.95||||0.315|TWO_SIDED|95.0|-2.8|0.9|||cLDA|||||0.90|-2.80|0.315
70943956|NCT02630706|141387841|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-1.0||||0.282|TWO_SIDED|95.0|-2.83|0.83|||cLDA|||||0.83|-2.83|0.282
70943957|NCT02630706|141387842|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|8.9||||0.001|TWO_SIDED|95.0|2.46|32.22||Nominal p-values were provided.|Logistic regression model|||||32.22|2.46|0.001
70954270|NCT00688870|141411080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.735||95.0|||||Fisher Exact|||For Swelling - Any, Fisher exact test was used to calculate p-value.||||0.735
71120795|NCT03410797|141747586|OTHER|Descriptive statistics characterized acoustic and aerodynamic measures, and patient perception measurements.|Median Difference (Net)|-52.0||||0.1141|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.1141
71081252|NCT01763827|141669165|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-15.77|||<|0.001|TWO_SIDED|95.0|-24.39|-7.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-7.14|-24.39|<0.001
71081253|NCT01763827|141669166|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-5.27||||0.72|TWO_SIDED|95.0|-13.27|2.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||2.73|-13.27|0.72
71081254|NCT01763827|141669166|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-20.59|||<|0.001|TWO_SIDED|95.0|-30.98|-10.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-10.20|-30.98|<0.001
71081255|NCT01763827|141669166|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-7.71||||0.027|TWO_SIDED|95.0|-16.86|1.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||1.45|-16.86|0.027
71081256|NCT01763827|141669166|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-11.73||||0.044|TWO_SIDED|95.0|-21.19|-2.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-2.27|-21.19|0.044
71081257|NCT01763827|141669167|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-6.23||||0.72|TWO_SIDED|95.0|-16.41|3.95||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||3.95|-16.41|0.72
71120796|NCT03410797|141747587|OTHER|Descriptive statistics characterized acoustic and aerodynamic measures, and patient perception measurements.|Median Difference (Net)|-1.7||||0.3329|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.3329
71120797|NCT01185964|141747589|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.672||||0.0615|TWO_SIDED|95.0|0.442|1.021|||Log Rank|||||1.021|0.442|0.0615
71120798|NCT01185964|141747592|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.463||||0.0003|TWO_SIDED|95.0|0.301|0.71|||Log Rank|||||0.710|0.301|0.0003
71120799|NCT01920893|141747600|SUPERIORITY||Least Square (LS) mean difference|-1.55||||0.0009|TWO_SIDED|95.0|-2.43|-0.67||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 300 mg QW vs Placebo|Analysis was performed by a mixed model repeated measures (MMRM) model.||-0.67|-2.43|0.0009
71120800|NCT05894538|141747616|SUPERIORITY||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.92|1.12|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.12|0.92|
71120801|NCT05894538|141747617|SUPERIORITY|Due to the low event rate, a posterior probability was not estimated.|Hazard Ratio (HR)|3.57|||||TWO_SIDED|95.0|0.74|17.18|||||Low event rate precluded covariate adjustment.|||17.18|0.74|
70954271|NCT00688870|141411080|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Swelling - Mild, Fisher exact test was used to calculate p-value.||||>0.99
71081258|NCT01763827|141669167|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-17.65|||<|0.001|TWO_SIDED|95.0|-26.67|-8.63||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm|||-8.63|-26.67|<0.001
71081259|NCT01763827|141669167|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-8.14||||0.027|TWO_SIDED|95.0|-17.54|1.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||1.26|-17.54|0.027
71081260|NCT01763827|141669167|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-13.23||||0.044|TWO_SIDED|95.0|-21.69|-4.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-4.77|-21.69|0.044
71081261|NCT01763827|141669168|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-4.59||||0.072|TWO_SIDED|95.0|-11.3|2.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||2.12|-11.30|0.072
71081262|NCT01763827|141669168|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-20.39|||<|0.001|TWO_SIDED|95.0|-30.11|-10.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-10.68|-30.11|<0.001
71081263|NCT01763827|141669168|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-5.71||||0.082|TWO_SIDED|95.0|-14.13|2.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||2.71|-14.13|0.082
71081264|NCT01763827|141669168|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-12.84||||0.044|TWO_SIDED|95.0|-22.14|-3.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baselie value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-3.54|-22.14|0.044
71120802|NCT05894538|141747620|SUPERIORITY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.6|1.45|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.45|0.60|
71120803|NCT05894538|141747624|OTHER||Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.61|0.96|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||0.96|0.61|
70855211|NCT02880956|141198379|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.099||0.425|TWO_SIDED|95.0|-0.275|0.116||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.116|-0.275|0.425
70855212|NCT02880956|141198379|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|0.85|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855213|NCT02880956|141198379|SUPERIORITY||LS Mean of Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.102||0.039|TWO_SIDED|95.0|-0.413|-0.011||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||-0.011|-0.413|0.039
70855214|NCT02880956|141198379|SUPERIORITY||Effect size/pooled SD|0.28|STANDARD_DEVIATION|0.77|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855215|NCT02880956|141198379|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.131||0.729|TWO_SIDED|95.0|-0.302|0.212||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.212|-0.302|0.729
70855216|NCT02880956|141198379|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|0.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855217|NCT02880956|141198379|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.128||0.671|TWO_SIDED|95.0|-0.198|0.307||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.307|-0.198|0.671
71120804|NCT05894538|141747624|OTHER||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.49|0.85|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||0.85|0.49|
71120805|NCT05894538|141747624|OTHER||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.52|0.92|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||0.92|0.52|
71120806|NCT05894538|141747624|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.72|1.36|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.36|0.72|
71120807|NCT05894538|141747625|OTHER||Odds Ratio (OR)|1.27|||||TWO_SIDED|95.0|1.03|1.56|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.56|1.03|
71120808|NCT05894538|141747625|OTHER||Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|1.0|1.51|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.51|1.00|
71120809|NCT05894538|141747625|OTHER||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.87|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.35|0.87|
71120810|NCT05894538|141747625|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.86|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.32|0.86|
71120811|NCT05894538|141747626|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.81|1.26|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.26|0.81|
71120812|NCT05894538|141747626|OTHER||Odds Ratio (OR)|1.29|||||TWO_SIDED|95.0|1.0|1.66|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.66|1.00|
71120813|NCT05894538|141747626|OTHER||Odds Ratio (OR)|1.52|||||TWO_SIDED|95.0|1.15|2.02|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||2.02|1.15|
71120814|NCT05894538|141747626|OTHER||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.86|1.47|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.47|0.86|
71120815|NCT05894538|141747627|OTHER||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.76|1.24|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.24|0.76|
71120816|NCT05894538|141747627|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.75|1.3|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.30|0.75|
71120817|NCT05894538|141747627|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.72|1.25|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.25|0.72|
71081265|NCT01763827|141669169|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-7.94||||0.72|TWO_SIDED|95.0|-18.81|2.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||2.92|-18.81|0.72
70943958|NCT02630706|141387842|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|10.69|||<|0.001|TWO_SIDED|95.0|2.95|38.71||Nominal p-values were provided.|Logistic regression model|||||38.71|2.95|<0.001
71120818|NCT05894538|141747627|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.75|1.28|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.28|0.75|
71120819|NCT05894538|141747628|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.84|1.33|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.33|0.84|
71120820|NCT05894538|141747628|OTHER||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.87|1.43|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.43|0.87|
71120821|NCT05894538|141747628|OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.91|1.55|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.55|0.91|
71120822|NCT05894538|141747628|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.75|1.26|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.26|0.75|
71120823|NCT05894538|141747629|OTHER||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.79|1.2|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.20|0.79|
70855218|NCT02880956|141198379|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|0.94|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70954272|NCT00688870|141411080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.477||95.0|||||Fisher Exact|||For Swelling - Moderate, Fisher exact test was used to calculate p-value.||||0.477
71081266|NCT01763827|141669169|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-16.33|||<|0.001|TWO_SIDED|95.0|-25.64|-7.02||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-7.02|-25.64|<0.001
71120824|NCT05894538|141747629|OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.63|1.02|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.02|0.63|
71120825|NCT05894538|141747629|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.69|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.14|0.69|
71120826|NCT05894538|141747629|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.84|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.35|0.84|
71120827|NCT05894538|141747630|OTHER||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.78|1.19|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.19|0.78|
71120828|NCT05894538|141747630|OTHER||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.92|1.39|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.39|0.92|
71120829|NCT05894538|141747630|OTHER||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.91|1.36|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.36|0.91|
71120830|NCT05894538|141747630|OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.82|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.21|0.82|
71120831|NCT05894538|141747631|SUPERIORITY||Difference in model estimate time unwell|-0.04|||||TWO_SIDED|95.0|-0.39|0.32|||||The interval is a highest-density credible interval.|||0.32|-0.39|
71120832|NCT02081638|141747646|OTHER||||||>|0.05||||||Threshold for statistical significance was a priori set to \<0.05|Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the change of sCD14 from baseline and month 12 measurement within each arm.||||>0.05
71120833|NCT02081638|141747646|OTHER|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the change of sCD14 from baseline and month 12 measurement within each arm.||||0.022
71120834|NCT02081638|141747647|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the change of sCD14 from baseline and month 12 measurement within each arm.||||0.13
71120835|NCT02081638|141747647|OTHER|||||||0.097|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the change of sCD14 from baseline and month 12 measurement within each arm.||||0.097
71120836|NCT02081638|141747647|OTHER|||||||0.0269|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the change of sCD14 from baseline and month 12 measurement within each arm.||||0.0269
71120837|NCT02081638|141747647|OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
71120838|NCT02081638|141747647|OTHER||||||||||||||||||Plasma biomarkers (CRP, sCD14, TF, IL-6) were log(e) transformed and a linear mixed effect model with the biomarker as outcome and with random slope per participant was used to calculate the percentage of change from baseline.|||
71120839|NCT02680574|141747658|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change of hemoglobin: Vadadustat minus Darbepoetin alfa|Least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.042|||TWO_SIDED|95.0|-0.09|0.07||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||0.07|-0.09|
71120840|NCT02680574|141747659|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per Food and Drug Administration \[FDA\]) and 1.3 (per European Medicines Agency \[EMA\]).|Hazard Ratio (HR)|1.16|||=|0.2015|TWO_SIDED|95.0|0.93|1.446|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0015 has been reported in this section.||1.446|0.930|=0.2015
71120841|NCT02680574|141747659|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.17|||=|0.0725|TWO_SIDED|95.0|1.012|1.355|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 382 and 344 respectively; median time to first event (Q1, Q3) = 50.07 (23.00, 82.86) weeks versus 51.93 (27.79, 91.00) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.355|1.012|=0.0725
71120842|NCT02680574|141747660|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.1|0.09||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||0.09|-0.10|
71081267|NCT01763827|141669169|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-8.58||||0.082|TWO_SIDED|95.0|-18.1|0.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||0.94|-18.10|0.082
71081268|NCT01763827|141669169|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-12.72||||0.044|TWO_SIDED|95.0|-20.89|-4.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-4.54|-20.89|0.044
71081269|NCT01763827|141669170|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|5.53||||0.007|TWO_SIDED|95.0|2.23|8.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||8.84|2.23|0.007
71081270|NCT01763827|141669170|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|8.48|||<|0.001|TWO_SIDED|95.0|5.53|11.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||11.43|5.53|<0.001
71081271|NCT01763827|141669170|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|4.81||||0.013|TWO_SIDED|95.0|0.85|8.78||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||8.78|0.85|0.013
71081272|NCT01763827|141669170|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|3.81||||0.044|TWO_SIDED|95.0|-0.77|8.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline visit|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||8.39|-0.77|0.044
71120843|NCT02680574|141747661|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.04|||=|0.777|TWO_SIDED|95.0|0.851|1.268|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0015 has been reported in this section.||1.268|0.851|=0.7770
71120844|NCT02680574|141747661|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.11|||=|0.2305|TWO_SIDED|95.0|0.972|1.267|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first MACE plus hospitalization for heart failure or thromboembolic events excluding vascular access thrombosis for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 451 and 424 respectively; median time to first event (Q1, Q3) = 42.86 (19.71, 73.43) weeks versus 43.86 (21.36, 80.43) weeks, respectively.||1.267|0.972|=0.2305
70954273|NCT00688870|141411080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.805||95.0|||||Fisher Exact|||For Redness - Any, Fisher exact test was used to calculate p-value.||||0.805
71081273|NCT01763827|141669171|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|5.91||||0.007|TWO_SIDED|95.0|1.67|10.16||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||10.16|1.67|0.007
71081274|NCT01763827|141669171|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|9.33|||<|0.001|TWO_SIDED|95.0|5.32|13.34||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||13.34|5.32|<0.001
71081275|NCT01763827|141669171|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|7.56||||0.013|TWO_SIDED|95.0|3.11|12.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||12.00|3.11|0.013
71081276|NCT01763827|141669171|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|5.53||||0.044|TWO_SIDED|95.0|2.22|8.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||8.84|2.22|0.044
71081277|NCT02179047|141669257|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.002|TWO_SIDED||||||ANOVA|||||||0.002
71081278|NCT02179047|141669258|SUPERIORITY||Hazard Ratio (HR)|1.05|STANDARD_DEVIATION|0.005||0.002|TWO_SIDED|95.0|||||ANOVA|||||||0.002
71081279|NCT02179047|141669259|SUPERIORITY||Hazard Ratio (HR)|1.39|STANDARD_DEVIATION|0.005||0.001|TWO_SIDED||||||ANCOVA|||||||0.001
71081280|NCT01393522|141669260|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1|TWO_SIDED||||||ANCOVA|||||||0.1
71081281|NCT01393522|141669260|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88|TWO_SIDED||||||t-test, 2 sided|||||||0.88
71081282|NCT01393522|141669261|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33|TWO_SIDED||||||t-test, 2 sided|||||||0.33
71081283|NCT01393522|141669262|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75|TWO_SIDED||||||ANCOVA|||||||0.75
71081284|NCT01393522|141669262|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|TWO_SIDED||||||t-test, 2 sided|||||||0.24
71081285|NCT01393522|141669263|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|TWO_SIDED||||||t-test, 2 sided|||||||0.16
71120845|NCT02680574|141747662|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.11|||=|0.5509|TWO_SIDED|95.0|0.817|1.501|||Gray's Test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0015 has been reported in this section.||1.501|0.817|=0.5509
71120846|NCT02680574|141747662|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.16|||=|0.2531|TWO_SIDED|95.0|0.947|1.42|||Gray's Test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first cardiovascular MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 198 and 178 respectively; median time to first event (Q1, Q3) = 45.57 (21.71, 73.29) weeks versus 47.36 (20.00, 88.43) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.420|0.947|=0.2531
71120847|NCT02680574|141747663|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|0.88|||=|0.4184|TWO_SIDED|95.0|0.61|1.258|||Gray's test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0015 has been reported in this section.||1.258|0.610|=0.4184
70855219|NCT02880956|141198379|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.13||0.876|TWO_SIDED|95.0|-0.235|0.276||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.276|-0.235|0.876
71081286|NCT01393522|141669264|SUPERIORITY_OR_OTHER_LEGACY|||||||0.41|TWO_SIDED||||||t-test, 2 sided|||||||0.41
71081287|NCT01393522|141669265|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09|TWO_SIDED||||||t-test, 2 sided|||||||0.09
71081288|NCT01393522|141669266|SUPERIORITY_OR_OTHER_LEGACY|||||||0.78|TWO_SIDED||||||t-test, 2 sided|||||||0.78
71081289|NCT03479008|141669267|OTHER||||||<|0.0001||||||Statistical significance level was set at p \<0.05 for all tests.|ANOVA|||This presents the p value for the thigh comparison baseline to during stimulation||||<0.0001
71081290|NCT03479008|141669267|SUPERIORITY||||||<|0.0001||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||This presents the p value for the calf comparisons between baseline and during stimulation.||||<0.0001
71081291|NCT03479008|141669267|OTHER||||||<|0.001||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||This statistical analysis presents the data for the biceps comparisons between baseline and during stimulation.||||<0.001
71081292|NCT03479008|141669268|SUPERIORITY||||||<|0.0001|||||||post-hoc analysis|with Bonferroni correction||The P value below applies to the VO2||||<0.0001
71081293|NCT03479008|141669268|SUPERIORITY||||||<|0.001|||||||post-hoc analysis|with Bonferroni correction||This p value applies to the VCO2||||<0.001
71120848|NCT02680574|141747663|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.01|||=|0.8613|TWO_SIDED|95.0|0.792|1.293|||Gray's test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first cardiovascular death for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 127 and 131 respectively; median time to first event (Q1, Q3) = 48.29 (28.86, 76.14) weeks versus 48.43 (21.29, 92.29) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.293|0.792|=0.8613
71120849|NCT02680574|141747664|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.04|||=|0.8041|TWO_SIDED|95.0|0.82|1.315|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0015 has been reported in this section.||1.315|0.820|=0.8041
70855220|NCT02880956|141198379|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|0.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71081294|NCT03479008|141669269|SUPERIORITY||||||<|0.0001|||||||post-hoc analysis|with Bonferroni correction||||||<0.0001
71081295|NCT03479008|141669270|SUPERIORITY||||||<|0.0001|||||||post-hoc analysis|with Bonferroni correction||||||<0.0001
71081296|NCT03479008|141669271|SUPERIORITY|||||||0.094|||||||post-hoc analysis|with Bonferroni correction||||||0.094
71081297|NCT03479008|141669272|SUPERIORITY|||||||0.011||||||Statistical significance level was set at p \<0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for Muscle bellies of Soleus (SO)||||0.011
71081298|NCT03479008|141669272|SUPERIORITY|||||||0.012|||||||ANOVA|Statistical significance level was set at p \< 0.05 for all tests.||Comparison of Vibration to Baseline for tibialis anterior (TA)||||0.012
71081299|NCT03479008|141669272|SUPERIORITY|||||||0.003||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for gastrocnemius lateralis (GL)||||0.003
71081300|NCT03479008|141669272|SUPERIORITY||||||<|0.001||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for vastus medialis (VM)||||<0.001
71081301|NCT03479008|141669272|SUPERIORITY||||||<|0.0001||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for vastus lateralis (VL)||||<0.0001
71081302|NCT03479008|141669272|SUPERIORITY|||||||0.59||||||Statistical significance level was set at p \<0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for rectus femoris (RF)||||0.59
71081303|NCT03479008|141669272|SUPERIORITY|||||||0.86||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for semitendinosus (ST)||||0.86
71081304|NCT03479008|141669272|SUPERIORITY|||||||0.006||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for deltoideus medius||||0.006
71081305|NCT00412932|141669277|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|one-sample t-test|||The sample size of this study was not based on the statistical power consideration and was considered as sufficient for the evaluation of the efficacy and safety of the proposed olmesartan medoxomil-based treatment regimen.||||<0.0001
71081306|NCT00412932|141669278|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||One-sample t-test|||||||<0.0001
71081307|NCT00412932|141669279|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments. This P-Value applies to both the daytime and nighttime periods.|one-sample t-test|||||||<0.0001
71081308|NCT00412932|141669280|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments. The P-Value of \<0.0001 applies to both daytime and nighttime periods.|one-sample t-test|||||||<0.0001
71081309|NCT01490840|141669286|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 90 in each group would have 80% power to detect a difference in means of 3.8, assuming that the common standard deviation is 9.05, using a two group t-test with a 0.05 2-sided significance level.|Mean Difference (Net)|-1.47||||0.4579|TWO_SIDED|95.0|-5.39|2.44|||ANCOVA|||||2.44|-5.39|0.4579
71081310|NCT00905567|141669311|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA's guidleines.|Ratio of the Least Squares Mean|93.01||||||90.0|||||||Bioequivalence is established when Ratio of the Least Squares Mean (test/reference x 100) falls within 80-125.|||||
71081311|NCT00905567|141669312|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA's guidleines.|Ratio of the Least Squares Mean|96.62||||||90.0|||||||Bioequivalence is established when the Ratio of the Least Squares Mean (test/reference x 100) falls within 80-125.|||||
71081312|NCT00905567|141669313|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA's guidleines.|Ratio of the Least Squares Mean|96.43||||||90.0|||||||Bioequivalence is established when the Ratio of the Least Squares Mean (test/reference x 100) falls within 80-125.|||||
70855221|NCT02880956|141198379|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.159||0.763|TWO_SIDED|95.0|-0.266|0.362||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.362|-0.266|0.763
70943959|NCT02630706|141387843|SUPERIORITY|Adjusted Odds Ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|8.34|||<|0.001|TWO_SIDED|95.0|2.52|27.6||Nominal p-values were provided.|Logistic regression model|||||27.60|2.52|<0.001
70943960|NCT02630706|141387843|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment, anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|8.29|||<|0.001|TWO_SIDED|95.0|2.44|28.11||Nominal p-values were provided.|Logistic regression model|||||28.11|2.44|<0.001
70943961|NCT02630706|141387844|OTHER||Difference in % (Ert. 15 mg. - placebo)|-9.0|||<|0.001||95.0|-14.5|-5.0|||Miettinen & Nurminen method|Miettinen \& Nurminen method stratified by country ('China' or 'other') for the overall population.||||-5.0|-14.5|<0.001
70943962|NCT02630706|141387844|OTHER||Difference in % (Ert. 5 mg. - placebo)|-8.4|||<|0.001|TWO_SIDED|95.0|-14.0|-4.4|||Miettinen & Nurminen method|Miettinen \& Nurminen method stratified by country ('China' or 'other') for the overall population.||||-4.4|-14.0|<0.001
70943963|NCT02630706|141387845|OTHER||Difference in % (Ert. 15 mg. - placebo)|-8.9||||0.001||95.0|-15.1|-4.2|||Miettinen & Nurminen method|||||-4.2|-15.1|0.001
70943964|NCT02630706|141387845|OTHER||Difference in % (Ert. 5 mg. - placebo)|-9.6|||<|0.001|TWO_SIDED|95.0|-15.8|-5.7|||Miettinen & Nurminen method|||||-5.7|-15.8|<0.001
70943965|NCT03790878|141387906|OTHER|||||||0.018|||||||ANCOVA|||||||0.018
70943966|NCT03790878|141387907|OTHER|||||||0.396|||||||Multilevel modeling|||||||0.396
70943967|NCT03790878|141387908|OTHER|||||||0.002|||||||Multilevel modeling|||||||0.002
71081313|NCT02542397|141669317|SUPERIORITY|"It has been reported that, based on the Edmonton Symptom Assessment Scale (ESAS) pain scale, about 30% of cancer patients receiving standard of care pain management experienced \>= 2-point improvement in pain score between visits \[Ref\].~Ref: Scharpf, J., et al., The role of pain in head and neck cancer recurrence and survivorship. Arch Otolaryngol Head Neck Surg, 2009. 135(8): p. 789-94."|Exact binomial proportion|0.5556|||<|0.0001|TWO_SIDED|95.0|0.414|0.6908||The a priori threshold for statistical significance was alpha = 0.10.|Exact binomial test of proportions|||A single-stage design was used to test the hypothesis that the pain improvement rate, assessed by the Edmonton Symptom Assessment Scale, is \<= 0.30. Our study targeted enrollment of 71 evaluable subjects for the final analysis; 54 subjects met the criteria at study closure. Assuming a one-sided alpha=0.10 significance level, 71 evaluable subjects would provide approximately 90% power to reject the null hypothesis (based on an exact binomial test) assuming the true pain improvement rate is 0.45.||.6908|.4140|<0.0001
71081314|NCT02362191|141669323|OTHER|||||||0.758||||||The threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.758
70855222|NCT02880956|141198379|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.11|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855223|NCT02880956|141198379|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.157||0.429|TWO_SIDED|95.0|-0.434|0.185||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.185|-0.434|0.429
70943968|NCT01180790|141387939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||||||To control for multiplicity, the proportion in each treatment group achieving RVR4 is analyzed using a Cochran-Armitage test for trend among the ordered groups: placebo (considered zero dose), 200 mg, 400 mg, and 800 mg ACH-0141625.|exact Cochran-Armitage test|Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo - active).||The null hypothesis is no difference between proportions of participants in each treatment group achieving RVR4 at Week 4 of the study, while the alternative hypothesis is that the proportion of participants achieving RVR4 at Week 4 increases with increasing doses of ACH-0141625.||||0.003
70943969|NCT01180790|141387939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Fisher Exact|||To control for multiplicity, the proportion in each treatment group achieving RVR4 is analyzed using a Cochran-Armitage test for trend among the ordered groups: placebo (considered zero dose), 200 mg ACH-0141625, 400 mg ACH-0141625, and 800 mg ACH-0141625. Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo - active).||||0.004
70943970|NCT01180790|141387939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Fisher Exact|||To control for multiplicity, the proportion in each treatment group achieving RVR4 is analyzed using a Cochran-Armitage test for trend among the ordered groups: placebo (considered zero dose), 200 mg ACH-0141625, 400 mg ACH-0141625, and 800 mg ACH-0141625. Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo - active).||||0.004
70943971|NCT01180790|141387939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Fisher Exact|||To control for multiplicity, the proportion in each treatment group achieving RVR4 is analyzed using a Cochran-Armitage test for trend among the ordered groups: placebo (considered zero dose), 200 mg ACH-0141625, 400 mg ACH-0141625, and 800 mg ACH-0141625. Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo - active).||||0.004
71081315|NCT02362191|141669324|OTHER|||||||0.4||||||The threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.40
71081316|NCT01473940|141669331|OTHER|||||||||||||P-Value not used||||A 3 + 3 enrollment design was adopted to monitor safety and determine the MTD based on DLTs obsesved. The MTD is the highest dose at which 0 of 3 or 1 of 6 DLTs are detected. The MTD is exceeded if 2 of 3 or 2 of 6 DLTs are detected. There will be no dose escalation within a cohort.|The number of DLTs seen at each cohort were used to determine the MTD for the expansion cohort. The MTD was determined to be Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kg|||
71081317|NCT00547248|141669338|NON_INFERIORITY|Non-inferiority was demonstrated if the difference in terms of incidence of post-immunization febrile reactions (rectal temperature \> 39.0°C) in Synflorix™ vaccine minus Prevenar™ did not exceed the pre-defined clinically acceptable threshold of 5% + half the incidence in Prevenar.|Difference in percentage|0.89|||||TWO_SIDED|95.0|-4.82|5.59|||Philips' statistical test|||||5.59|-4.82|
71081318|NCT00534248|141669371|SUPERIORITY_OR_OTHER||point estimate|0.698|||<|0.001|TWO_SIDED|95.0|0.541|0.806|||Conditional Exact Method||The point estimate was for vaccine efficacy with respect to incidence of HZ.|Vaccine efficacy with respect to HZ was defined as the relative reduction in incidence rate of HZ point estimate (95% CI) calculated as 1 minus the ratio of the estimated incidence rates of HZ in the zoster vaccine group and the placebo group.||.806|.541|<.001
71081319|NCT00534248|141669372|SUPERIORITY_OR_OTHER||geometric mean titre ratio|2.3|||<|0.001|TWO_SIDED|95.0|2.2|2.4|||linear mixed longitudinal analysis model|||||2.4|2.2|<.001
71081320|NCT00534248|141669373|SUPERIORITY_OR_OTHER||Relative Risk|1.133|||||TWO_SIDED|95.0|0.805|1.595||||||Analysis of proportion of participants reporting one or more serious adverse experiences reported within 42 days postvaccination.||1.595|.805|
71120850|NCT02680574|141747664|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.09|||=|0.4577|TWO_SIDED|95.0|0.93|1.274|||Log Rank|||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first all-cause mortality for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 319 and 307 respectively; median time to first event (Q1, Q3) = 52.14 (28.71, 84.71) weeks versus 53.00 (30.71, 94.14) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.274|0.930|=0.4577
71120851|NCT02847858|141747675|SUPERIORITY||Slope|1.16||||0.011|TWO_SIDED|95.0|0.26|2.07||Arm by Time interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Arm comparison is Arm 1 (Intervention) minus Arm2 (Control); Time comparison is Post-visit Follow-up minus Baseline|Null hypothesis: No difference between study arms in change in mean self-efficacy from Baseline to Post-visit Follow-up||2.07|0.26|0.011
70855224|NCT02880956|141198379|SUPERIORITY||Effect size/pooled SD|0.12|STANDARD_DEVIATION|1.01|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855225|NCT02880956|141198379|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.162||0.701|TWO_SIDED|95.0|-0.256|0.381||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.381|-0.256|0.701
71120852|NCT02847858|141747675|SUPERIORITY||Slope|1.64|||<|0.001|TWO_SIDED|95.0|1.01|2.07||Post hoc comparison pursuant to significant Arm by Time interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Time comparison is Post-visit Follow-up minus Baseline|Null hypothesis: No Time difference (Post-visit Follow-up vs. Baseline) in outcome||2.07|1.01|<0.001
71120853|NCT02847858|141747675|SUPERIORITY||Slope|0.48||||0.108|TWO_SIDED|95.0|-0.1|1.05||Post hoc comparison pursuant to significant Arm by Time interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Time comparison is Post-visit Follow-up minus Baseline|Null hypothesis: No Time difference (Post-visit Follow-up vs. Baseline) in outcome||1.05|-0.10|0.108
70855226|NCT02880956|141198379|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|1.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70954274|NCT00688870|141411080|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Redness - Mild, Fisher exact test was used to calculate p-value.||||>0.99
71081321|NCT02259400|141669389|NON_INFERIORITY_OR_EQUIVALENCE|For the calculation of sample size we used the duration of ventilation as the main primary outcome. As no basic data are available for this population, we were able to retrieve from the database of our two NICUs the duration of ventilation on NIV. We assumed a difference of 24-h between the two groups in the duration of NIV as clinically relevant. We used a confidence level α=0.05; the power level desired was 0.80 and consequently we needed 62 patients for each group.|||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
71081322|NCT02964338|141669436|OTHER||Least square (LS) mean difference|3.5||||0.2741|TWO_SIDED|95.0|-2.8|9.82||Threshold for significance at 0.05 level.|ANCOVA|||||9.82|-2.80|0.2741
71081323|NCT02964338|141669436|OTHER||LS mean difference|-3.3||||0.3047|TWO_SIDED|95.0|-9.59|3.01||Threshold for significance at 0.05 level.|ANCOVA|||||3.01|-9.59|0.3047
71081324|NCT00112918|141669449|SUPERIORITY_OR_OTHER|||||||0.2024||95.0|||||Closed test procedure|||Adjustments for multiplicity was done using a closed test procedure which tests for differences between all three treatment groups at the 5% alpha level first. Only in case of a significant result, the pair-wise comparison between the control arm and each of the bevacizumab arm will be tested, again at the 5% alpha level.||||0.2024
71081325|NCT00435461|141669490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.2|-0.7|||ANCOVA|||||-0.7|-1.2|<0.001
71081326|NCT00435461|141669490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.2|-0.7|||ANCOVA|||||-0.7|-1.2|<0.001
71081327|NCT00435461|141669490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.816|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|||||0.2|-0.3|0.816
71081328|NCT00435461|141669491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.6|-0.9|||ANCOVA|||||-0.9|-1.6|<0.001
71081329|NCT00435461|141669491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.4|-0.7|||ANCOVA|||||-0.7|-1.4|<0.001
71081330|NCT00435461|141669491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.136|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||||0.1|-0.6|0.136
71081331|NCT00435461|141669492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.5|-0.7|||ANCOVA|||||-0.7|-1.5|<0.001
70943972|NCT01180790|141387941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.34||||||To control for multiplicity, the proportion of participants in each treatment group achieving cEVR is analyzed using a Cochran-Armitage test for trend among the ordered treatment groups: 200 mg ACH-0141625, 400 mg ACH-0141625, and 800 mg ACH-0141625.|Exact Cochran-Armitage test|Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo - active).||The null hypothesis is no difference between proportions of participants in each treatment group achieving cEVR at Week 12 of the study, while the alternative hypothesis is that the proportion of participants achieving cEVR at Week 12 increases with increasing doses of ACH-0141625.||||0.34
70943973|NCT00562484|141387981|SUPERIORITY_OR_OTHER||Vaccine Efficacy|42.0|||||TWO_SIDED|95.0|30.0|52.0||||||Vaccine efficacy = 100 x (1 - ratio of incidence rate)||52|30|
70943974|NCT00562484|141387982|SUPERIORITY_OR_OTHER||Vaccine efficacy|60.0|||||TWO_SIDED|95.0|44.0|72.0||||||Vaccine efficacy = 100 x (1 - ratio of incidence rate)||72|44|
70943975|NCT02811302|141387994|OTHER|A simple count and percentage of the population were calculated based on the number of patients adjudicated as having Respiratory Depression.|||||||||||||||||To determine the risk assessment score, first the number of patients with Respiratory Depression (RD) had to be identified. Per the rules established for the Clinical Endpoint Committee, 655 (43.6%) patients were identified as having RD.|||
70943976|NCT02811302|141387995|OTHER|Multivariable model for (Multivariate logistic regression) Respiratory Depression, followed by validation with Harrell's Optimism using a bootstrap sampling method.|Area Under the Curve|0.76|||||TWO_SIDED|95.0|0.73|0.79|||||The model was performed using stepwise selection including all potential predictors and interactions terms (medical history and baseline characteristics).|A modified Full Analysis Dataset (1335) was used to derive and validate the risk assessment tool. Subjects were excluded if they had major deviations or consent withdrawals. Subjects that did not have any monitoring data were also excluded. Finally, 69 subjects were further excluded from the model, as they were missing parameters to calculate their risk score.|The model derived from the logistic regression was assessed by the Hosmer-Lemshow goodness of fit test (P = 0.831). The derived model was validated by Harrell's Optimism using a Bootstrap sampling method (500 samples from the modified dataset, 1335) with replacement. The logistic regression model with stepwise selection was performed for each bootstrap sample, and AUC calculated. The optimism calculated by Harrell's algorithm was 0.02. The model was then checked for the quartiles of the effective monitoring and for geography used as a random effect. The performance measurement of the final model was adjusted according the Harrell's Optimism for a final adjusted AUC of 0.74.|0.79|0.73|
70943977|NCT01568112|141388066|SUPERIORITY_OR_OTHER||Difference in percentage|-9.0|||||TWO_SIDED|95.0|-30.8|12.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||12.9|-30.8|
70943978|NCT01568112|141388066|SUPERIORITY_OR_OTHER||Difference in percentage|7.0|||||TWO_SIDED|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||27.8|-14.1|
71120854|NCT02847858|141747676|SUPERIORITY||F statistic:Time X Arm Interaction|3.23||||0.04|TWO_SIDED|||||Arm by Time interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|df=2,1611; Arm comparison is Intervention - Control; Time comparisons are 3 months - Baseline and 6 months - Baseline and 6 months - 3 months|Null hypothesis: No difference between study arms in change in mean self-efficacy from Baseline to 3 months or from Baseline to 6 months||||0.04
71120855|NCT02847858|141747676|SUPERIORITY||Slope|0.82||||0.218|TWO_SIDED|95.0|-0.48|2.11||Post hoc comparison pursuant to significant Arm by Time interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site||Null hypothesis: No difference between study arms in change in mean self-efficacy from Baseline to 3 months|Arm comparison is Intervention - Control; Time comparison is 3 months - Baseline|2.11|-0.48|.218
70943979|NCT01568112|141388066|SUPERIORITY_OR_OTHER||Difference in percentage|-9.0|||||TWO_SIDED|95.0|-30.8|12.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall redness events||12.9|-30.8|
71081332|NCT00435461|141669492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.2|-0.4|||ANCOVA|||||-0.4|-1.2|<0.001
71081333|NCT00435461|141669492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.136|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||||0.1|-0.7|0.136
71081334|NCT00435461|141669493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.6|-0.8|||ANCOVA|||||-0.8|-1.6|<0.001
71081335|NCT00435461|141669493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.3|-0.6|||ANCOVA|||||-0.6|-1.3|<0.001
71081336|NCT00435461|141669493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.136|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||||0.1|-0.6|0.136
71081337|NCT00435461|141669494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.15||0.001|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|||||-0.2|-0.8|0.001
71081338|NCT00435461|141669494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.106|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||0|-0.6|0.106
71081339|NCT00435461|141669494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.286|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|0.286
71081340|NCT00435461|141669495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.007|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|||||-0.1|-0.7|0.007
70943980|NCT01568112|141388066|SUPERIORITY_OR_OTHER||Difference in percentage|4.0|||||TWO_SIDED|95.0|-16.4|25.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall redness events||25.5|-16.4|
70943981|NCT01568112|141388066|SUPERIORITY_OR_OTHER||Difference in percentage|-21.0|||||TWO_SIDED|95.0|-41.7|1.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall tingling events||1.3|-41.7|
70943982|NCT01568112|141388066|SUPERIORITY_OR_OTHER||Difference in percentage|-3.0|||||TWO_SIDED|95.0|-23.3|18.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall tingling events||18.7|-23.3|
70943983|NCT01568112|141388066|SUPERIORITY_OR_OTHER||Difference in percentage|-14.0|||||TWO_SIDED|95.0|-35.2|8.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall itching events||8.3|-35.2|
71081341|NCT00435461|141669495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.286|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|0.286
70943984|NCT01568112|141388066|SUPERIORITY_OR_OTHER||Difference in percentage|12.0|||||TWO_SIDED|95.0|-9.5|32.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall itching events||32.2|-9.5|
70943985|NCT01568112|141388066|SUPERIORITY_OR_OTHER||Difference in percentage|-9.0|||||TWO_SIDED|95.0|-30.8|12.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall warmth events||12.9|-30.8|
71120856|NCT02847858|141747676|SUPERIORITY||Slope|1.58||||0.008|TWO_SIDED|95.0|0.38|2.77||Post hoc comparison pursuant to significant Arm by Time interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Arm comparison is Intervention - Control; Time comparison is 6 months - Baseline|Null hypothesis: No difference between study arms in change in mean self-efficacy from Baseline to 6 months||2.77|0.38|0.008
71120857|NCT02847858|141747677|SUPERIORITY||F statistic:Time X Arm Interaction|3.72||||0.025|TWO_SIDED|||||Arm by Time Interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|df=2, 1007; Arm comparison is Intervention/Control; Time comparisons are 3 months/Baseline and 6 months/Baseline and 6 months/3 months|Null hypothesis: No difference between arms in change in percentage of participants using non-barrier method from Baseline to 3 months or to 6 months||||0.025
71120858|NCT02847858|141747677|SUPERIORITY||Odds Ratio (OR)|3.29||||0.042|TWO_SIDED|95.0|1.04|10.36||Post hoc comparison pursuant to significant Arm by Time Interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Arm comparison is Intervention / Control; Time comparison is 3 months / Baseline|Null hypothesis: No difference between arms in change in percentage of participants using non-barrier method from Baseline to 3 months||10.36|1.04|0.042
70943986|NCT01568112|141388066|SUPERIORITY_OR_OTHER||Difference in percentage|5.0|||||TWO_SIDED|95.0|-16.4|25.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall warmth events||25.5|-16.4|
70943987|NCT01568112|141388067|SUPERIORITY_OR_OTHER||Difference in percentage|-14.0|||||TWO_SIDED|95.0|-35.2|8.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||8.3|-35.2|
70943988|NCT01568112|141388067|SUPERIORITY_OR_OTHER||Difference in percentage|12.0|||||TWO_SIDED|95.0|-9.5|32.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||32.2|-9.5|
70943989|NCT01568112|141388067|SUPERIORITY_OR_OTHER||Difference in percentage|-19.0|||||TWO_SIDED|95.0|-39.6|3.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||3.7|-39.6|
70943990|NCT01568112|141388067|SUPERIORITY_OR_OTHER||Difference in percentage|7.0|||||TWO_SIDED|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||27.8|-14.1|
71081342|NCT00435461|141669495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.106|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|0.106
71081343|NCT00435461|141669496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.15||0.003|TWO_SIDED|95.0|-0.7|-0.2|||ANCOVA|||||-0.2|-0.7|0.003
71081344|NCT00435461|141669496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.286|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|0.286
71081345|NCT00435461|141669496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.106|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||0|-0.6|0.106
71120859|NCT02847858|141747677|SUPERIORITY||Odds Ratio (OR)|5.54||||0.005|TWO_SIDED|95.0|1.7|18.06||Post hoc comparison pursuant to significant Arm by Time Interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Arm comparison is Intervention / Control; Time comparison is 6 months / Baseline|Null hypothesis: No difference between arms in change in percentage of participants using non-barrier method from Baseline to 6 months||18.06|1.7|0.005
71120860|NCT02847858|141747678|SUPERIORITY||Slope|1.62|||<|0.001|TWO_SIDED|95.0|1.43|1.82||Time main effect; a priori threshold for statistical significance p \<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Time comparison is post-app minus pre-app|Null hypothesis: No change in contraception knowledge from immediate pre-app to immediate post-app among Intervention group participants||1.82|1.43|<0.001
71120861|NCT02847858|141747679|SUPERIORITY||Odds Ratio (OR)|2.22||||0.055|TWO_SIDED|95.0|0.98|5.01||Arm main effect; a priori threshold for statistical significance p\<.05|Regression, Logistic|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; clustering by recruitment site|Arm comparison is Arm 1 (Intervention) / Arm2 (Control)|Null hypothesis: No difference between study arms in percentage of participants who discussed birth control with health care provider at visit||5.01|0.98|0.055
71120862|NCT02847858|141747680|SUPERIORITY||Odds Ratio (OR)|1.66||||0.227|TWO_SIDED|95.0|0.73|3.78||Arm main effect; a priori threshold for statistical significance p\<.05|Regression, Logistic|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; clustering by recruitment site|Arm comparison is Arm 1 (Intervention) / Arm2 (Control)|Null hypothesis: No difference between study arms in percentage of participants who receive/make appointment/get prescription for a non-barrier method||3.78|0.73|0.227
71081346|NCT00435461|141669497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.7|-1.0|||ANCOVA|||Pre-dose iTNSS||-1|-1.7|<0.001
70855227|NCT02880956|141198380|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.064||0.867|TWO_SIDED|95.0|-0.115|0.137||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.137|-0.115|0.867
70943991|NCT01568112|141388067|SUPERIORITY_OR_OTHER||Difference in percentage|-21.0|||||TWO_SIDED|95.0|-41.7|1.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||1.3|-41.7|
70855228|NCT02880956|141198380|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|0.48|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855229|NCT02880956|141198380|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.063||0.898|TWO_SIDED|95.0|-0.132|0.116||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.116|-0.132|0.898
70855230|NCT02880956|141198380|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|0.51|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70943992|NCT01568112|141388067|SUPERIORITY_OR_OTHER||Difference in percentage|7.0|||||TWO_SIDED|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||27.8|-14.1|
71081347|NCT00435461|141669497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.4|-0.7|||ANCOVA|||Pre-dose iTNSS||-0.7|-1.4|<0.001
71081348|NCT00435461|141669497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.193|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||Pre-dose iTNSS||0.1|-0.6|0.193
71081349|NCT00435461|141669497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|||Pre-dose iTOSS||-0.2|-0.8|<0.001
70855231|NCT02880956|141198380|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.065||0.537|TWO_SIDED|95.0|-0.088|0.168||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.168|-0.088|0.537
70855232|NCT02880956|141198380|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|0.54|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855233|NCT02880956|141198380|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.074||0.176|TWO_SIDED|95.0|-0.245|0.045||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.045|-0.245|0.176
70943993|NCT01568112|141388067|SUPERIORITY_OR_OTHER||Difference in percentage|-33.0|||||TWO_SIDED|95.0|-52.2|-10.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||-10.6|-52.2|
70943994|NCT01568112|141388067|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-21.0|21.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||21.0|-21.0|
70943995|NCT01568112|141388067|SUPERIORITY_OR_OTHER||Difference in percentage|-21.0|||||TWO_SIDED|95.0|-41.7|1.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||1.3|-41.7|
71081350|NCT00435461|141669497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.058|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||Pre-dose iTOSS||0|-0.6|0.058
71081351|NCT00435461|141669497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.16|TWO_SIDED|95.0|-0.5|0.0|||ANCOVA|||Pre-dose iTOSS||0|-0.5|0.16
71081352|NCT00435461|141669498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.8|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|95.0|5.7|11.9|||ANCOVA|||Morning assessment||11.9|5.7|<0.001
71081353|NCT00435461|141669498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.4|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|95.0|5.3|11.5|||ANCOVA|||Morning assessment||11.5|5.3|<0.001
71120863|NCT02305849|141747698|SUPERIORITY||Percent Difference|36.9|||<|0.001|TWO_SIDED|95.0|26.7|47.0||Closed testing procedure was used for multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution.|Treatment Difference vs Placebo||47.0|26.7|<0.001
71120864|NCT02305849|141747698|SUPERIORITY||Percent difference|42.6|||<|0.001|TWO_SIDED|95.0|32.6|52.6||Closed testing procedure was used for multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution.|Treatment Difference vs Placebo||52.6|32.6|<0.001
71120865|NCT02305849|141747699|SUPERIORITY||||||<|0.001||||||Closed testing procedure was used for multiplicity adjustment.|RANCOVA|Based on Rank Analysis of Covariance (RANCOVA) Model: Rank of mTSS Change = Treatment + Baseline Rank of mTSS.||Treatment Difference vs Placebo||||<0.001
71120866|NCT02305849|141747699|SUPERIORITY||||||<|0.001||||||Closed testing procedure was used for multiplicity adjustment.|RANCOVA|Based on RANCOVA Model: Rank of mTSS Change = Treatment + Baseline Rank of mTSS.||Treatment Difference vs Placebo||||<0.001
71120867|NCT02305849|141747701|SUPERIORITY||Percent Difference|22.2|||<|0.001|TWO_SIDED|95.0|13.8|30.7||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||30.7|13.8|<0.001
71120868|NCT02305849|141747701|SUPERIORITY||Percent Difference|38.3|||<|0.001|TWO_SIDED|95.0|29.3|47.3||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||47.3|29.3|<0.001
71120869|NCT02305849|141747703|SUPERIORITY||Percent Difference|9.7|||<|0.001|TWO_SIDED|95.0|3.8|15.6||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||15.6|3.8|<0.001
71120870|NCT02305849|141747703|SUPERIORITY||Percent Difference|21.2|||<|0.001|TWO_SIDED|95.0|13.9|28.5||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||28.5|13.9|<0.001
71120871|NCT02305849|141747705|SUPERIORITY||||||<|0.001||||||Based on RANCOVA Model: Rank of mTSS Change = Treatment + Baseline Rank of mTSS.|RANCOVA|||Treatment Difference vs Placebo||||<0.001
71120872|NCT02305849|141747705|SUPERIORITY||||||<|0.001||||||Based on RANCOVA Model: Rank of mTSS Change = Treatment + Baseline Rank of mTSS.|RANCOVA|||Treatment Difference vs Placebo||||<0.001
71120873|NCT02305849|141747706|SUPERIORITY|||||||0.018|||||||RANCOVA|Based on RANCOVA Model: Rank of JSN Score Change = Treatment + Baseline Rank of JSN score.||Week 28/ET: Treatment Difference vs Placebo||||0.018
71120874|NCT02305849|141747706|SUPERIORITY|||||||0.002|||||||RANCOVA|Based on RANCOVA Model: Rank of JSN Score Change = Treatment + Baseline Rank of JSN score.||Week 28/ET: Treatment Difference vs Placebo||||0.002
71120875|NCT02305849|141747706|SUPERIORITY|||||||0.039|||||||RANCOVA|Based on RANCOVA Model: Rank of JSN Score Change = Treatment + Baseline Rank of JSN Score.||Week 52/ET: Treatment Difference vs Placebo||||0.039
71120876|NCT02305849|141747706|SUPERIORITY|||||||0.006|||||||RANCOVA|Based on RANCOVA Model: Rank of JSN Score Change = Treatment + Baseline Rank of JSN Score.||Week 52/ET: Treatment Difference vs Placebo||||0.006
71120877|NCT02305849|141747707|SUPERIORITY|||||||0.036|||||||RANCOVA|Based on RANCOVA Model: Rank of Erosion Score Change = Treatment + Baseline Rank of Erosion Score.||Week 28/ET: Treatment Difference vs Placebo||||0.036
71120878|NCT02305849|141747707|SUPERIORITY||||||<|0.001|||||||RANCOVA|Based on RANCOVA Model: Rank of Erosion Score Change = Treatment + Baseline Rank of Erosion Score.||Week 28/ET: Treatment Difference vs Placebo||||<0.001
71120879|NCT02305849|141747707|SUPERIORITY|||||||0.013|||||||RANCOVA|Based on RANCOVA Model: Rank of Erosion Score Change = Treatment + Baseline Rank of Erosion Score.||Week 52/ET: Treatment Difference vs Placebo||||0.013
71120880|NCT02305849|141747707|SUPERIORITY||||||<|0.001|||||||RANCOVA|Based on RANCOVA Model: Rank of Erosion Score Change = Treatment + Baseline Rank of Erosion Score.||Week 52/ET: Treatment Difference vs Placebo||||<0.001
71120881|NCT02305849|141747708|SUPERIORITY||Percent Difference|21.3|||<|0.001|TWO_SIDED|95.0|10.0|32.6||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Week 28/ET: Treatment Difference vs Placebo||32.6|10.0|<0.001
70855234|NCT02880956|141198380|SUPERIORITY||Effect size/pooled SD|0.15|STANDARD_DEVIATION|0.65|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71120882|NCT02305849|141747708|SUPERIORITY||Percent Difference|26.8|||<|0.001|TWO_SIDED|95.0|15.7|37.9||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Week 28/ET: Treatment Difference vs Placebo||37.9|15.7|<0.001
70943996|NCT01568112|141388067|SUPERIORITY_OR_OTHER||Difference in percentage|18.0|||||TWO_SIDED|95.0|-2.4|38.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||38.8|-2.4|
71120883|NCT02305849|141747708|SUPERIORITY||Percent Difference|21.5|||<|0.001|TWO_SIDED|95.0|10.2|32.9||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Week 52/ET: Treatment Difference vs Placebo||32.9|10.2|<0.001
71120884|NCT02305849|141747708|SUPERIORITY||Percent Difference|26.4|||<|0.001|TWO_SIDED|95.0|15.2|37.6||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Week 52/ET: Treatment Difference vs Placebo||37.6|15.2|<0.001
71120885|NCT02305849|141747709|SUPERIORITY||LS Mean difference|-1.21|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.46|-0.97||No multiplicity adjustment.|ANCOVA|Based on ANCOVA (analysis of covariance) Model: DAS28 Change = Treatment + Baseline DAS28.||Treatment Difference vs Placebo||-0.97|-1.46|<0.001
71120886|NCT02305849|141747709|SUPERIORITY||LS Mean difference|-1.59|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.85|-1.33||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: DAS28 Change = Treatment + Baseline DAS28.||Treatment Difference vs Placebo||-1.33|-1.85|<0.001
71120887|NCT02305849|141747711|SUPERIORITY||LS Mean difference|-1.19|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.44|-0.94||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: DAS28 Change = Treatment + Baseline DAS28.||Treatment Difference vs Placebo||-0.94|-1.44|<0.001
71120888|NCT02305849|141747711|SUPERIORITY||LS Mean difference|-1.63|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.89|-1.36||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: DAS28 Change = Treatment + Baseline DAS28.||Treatment Difference vs Placebo||-1.36|-1.89|<0.001
71120889|NCT02305849|141747713|SUPERIORITY||LS Mean difference|-5.2|STANDARD_ERROR_OF_MEAN|0.9|<|0.001||95.0|-6.9|-3.5||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: TJC68 Change = Treatment + Baseline TJC68.||Treatment Difference vs Placebo||-3.5|-6.9|<0.001
71120890|NCT02305849|141747713|SUPERIORITY||LS Mean difference|-7.2|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|-8.9|-5.6||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: TJC68 Change = Treatment + Baseline TJC68.||Treatment Difference vs Placebo||-5.6|-8.9|<0.001
71120891|NCT02305849|141747715|SUPERIORITY||LS Mean difference|-3.9|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-5.3|-2.6||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SJC66 Change = Treatment + Baseline SJC66.||Treatment Difference vs Placebo||-2.6|-5.3|<0.001
71120892|NCT02305849|141747715|SUPERIORITY||LS Mean difference|-5.6|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-6.9|-4.3||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SJC66 Change = Treatment + Baseline SJC66.||Treatment Difference vs Placebo||-4.3|-6.9|<0.001
71120893|NCT02305849|141747717|SUPERIORITY||Percent Difference|23.7|||<|0.001|TWO_SIDED|95.0|15.1|32.3||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||32.3|15.1|<0.001
71120894|NCT02305849|141747717|SUPERIORITY||Percent Difference|27.4|||<|0.001|TWO_SIDED|95.0|18.6|36.2||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||36.2|18.6|<0.001
71120895|NCT02305849|141747719|SUPERIORITY||Percent Difference|10.4|||<|0.001|TWO_SIDED|95.0|4.3|16.5||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected)|Treatment Difference vs Placebo||16.5|4.3|<0.001
71120896|NCT02305849|141747719|SUPERIORITY||Percent Difference|16.9|||<|0.001|TWO_SIDED|95.0|10.0|23.9||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected)|Treatment Difference vs Placebo||23.9|10.0|<0.001
71120897|NCT02305849|141747721|SUPERIORITY||Percent Difference|34.7|||<|0.001|TWO_SIDED|95.0|25.1|44.2||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||44.2|25.1|<0.001
71120898|NCT02305849|141747721|SUPERIORITY||Percent Difference|45.5|||<|0.001|TWO_SIDED|95.0|36.0|55.0||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||55.0|36.0|<0.001
71120899|NCT02305849|141747723|SUPERIORITY||Percent Difference|20.3|||<|0.001|TWO_SIDED|95.0|12.5|28.1||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||28.1|12.5|<0.001
71120900|NCT02305849|141747723|SUPERIORITY||Percent Difference|31.5|||<|0.001|TWO_SIDED|95.0|23.1|40.0||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||40.0|23.1|<0.001
71120901|NCT02305849|141747725|SUPERIORITY||LS Mean Difference|-1.597|STANDARD_ERROR_OF_MEAN|0.178|<|0.001|TWO_SIDED|95.0|-1.948|-1.247||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: CRP Change = Treatment + Baseline CRP.||Treatment Difference vs Placebo||-1.247|-1.948|<0.001
71120902|NCT02305849|141747725|SUPERIORITY||LS Mean Difference|-1.458|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.852|-1.065||No multiplicity adjustment.|ANCOVA|||Treatment Difference vs Placebo||-1.065|-1.852|<0.001
71120903|NCT02305849|141747727|SUPERIORITY||LS Mean Difference|-17.89|STANDARD_ERROR_OF_MEAN|1.89|<|0.001|TWO_SIDED|95.0|-21.61|-14.17||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: ESR Change = Treatment + Baseline ESR.||Treatment Difference vs Placebo||-14.17|-21.61|<0.001
71120904|NCT02305849|141747727|SUPERIORITY||LS Mean Difference|-20.61|STANDARD_ERROR_OF_MEAN|2.06|<|0.001|TWO_SIDED|95.0|-24.67|-16.56||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: ESR Change = Treatment + Baseline ESR.||Treatment Difference vs Placebo||-16.56|-24.67|<0.001
70943997|NCT01568112|141388068|SUPERIORITY_OR_OTHER||Difference in percentage|-14.0|||||TWO_SIDED|95.0|-35.6|9.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||9.2|-35.6|
71081354|NCT00435461|141669498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.59||0.779|TWO_SIDED|95.0|-3.6|2.7|||ANCOVA|||Morning assessment||2.7|-3.6|0.779
71081355|NCT00435461|141669498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3|STANDARD_ERROR_OF_MEAN|1.65|<|0.001|TWO_SIDED|95.0|3.1|9.6|||ANCOVA|||Evening assessment||9.6|3.1|<0.001
71081356|NCT00435461|141669498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|STANDARD_ERROR_OF_MEAN|1.65|<|0.001|TWO_SIDED|95.0|3.8|10.3|||ANCOVA|||Evening assessment||10.3|3.8|<0.001
71081357|NCT00435461|141669498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|1.65||0.662|TWO_SIDED|95.0|-2.5|4.0|||ANCOVA|||Evening assessment||4|-2.5|0.662
71081358|NCT00435461|141669499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.7|-0.3|||ANCOVA|||||-0.3|-0.7|<0.001
71081359|NCT00435461|141669499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.203|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.203
71081360|NCT00435461|141669499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.8|-0.4|||ANCOVA|||||-0.4|-0.8|<0.001
71120905|NCT02305849|141747729|SUPERIORITY||Percent Difference|33.0|||<|0.001|TWO_SIDED|95.0|23.7|42.2||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||42.2|23.7|<0.001
70943998|NCT01568112|141388068|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0|||||TWO_SIDED|95.0|-24.7|21.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||21.7|-24.7|
70943999|NCT01568112|141388068|SUPERIORITY_OR_OTHER||Difference in percentage|-14.0|||||TWO_SIDED|95.0|-35.6|9.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||9.2|-35.6|
70944000|NCT01568112|141388068|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-22.9|23.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||23.7|-22.9|
70944001|NCT01568112|141388068|SUPERIORITY_OR_OTHER||Difference in percentage|-11.0|||||TWO_SIDED|95.0|-33.0|11.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||11.9|-33.0|
70944002|NCT01568112|141388068|SUPERIORITY_OR_OTHER||Difference in percentage|-5.0|||||TWO_SIDED|95.0|-27.5|18.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||18.8|-27.5|
71081361|NCT00551525|141669511|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significance level 0.05, two-sided test|binomial proportion|||||||<0.001
71081362|NCT00551525|141669514|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.984|||||TWO_SIDED|95.0|0.91|1.063||||||Modeling the association of age with the occurrence of any acute radiotherapy-related adverse event, adjusting for clinical T-stage (pT2 vs. pT3 \[reference level\]), baseline PSA, and Gleason score (\<8 vs. 8-10\[reference level\]).||1.063|0.910|
71081363|NCT00551525|141669514|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.89|1.169||||||Modeling the association of baseline PSA with the occurrence of any acute radiotherapy-related adverse event, adjusting for clinical T-stage (pT2 vs. pT3 \[reference level\]), Gleason score (\<8 vs. 8-10\[reference level\]), and age.||1.169|0.890|
71081364|NCT00551525|141669514|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.307|||||TWO_SIDED|95.0|0.364|4.697||||||Modeling the association of clinical T-stage (pT2 vs. pT3 \[reference level\]) with the occurrence of any acute radiotherapy-related adverse event, adjusting for baseline PSA, Gleason score (\<8 vs. 8-10\[reference level\]), and age.||4.697|0.364|
71081365|NCT00551525|141669514|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.659|||||TWO_SIDED|95.0|0.217|2.006||||||Modeling the association of Gleason score (\<8 vs. 8-10\[reference level\]) with the occurrence of any acute radiotherapy-related adverse event, adjusting for clinical T-stage (pT2 vs. pT3 \[reference level\]), baseline PSA, and age.||2.006|0.217|
71081366|NCT04676724|141669550|OTHER||Difference in SVR Rate|-3.0|||||TWO_SIDED|95.0|-29.0|11.0|||||The point estimate of SVR and its 95% highest posterior density Credible Interval (CI) are estimated from a Bayesian model that incorporates the analysis stratification factors and treatment arm.|||11|-29|
71081367|NCT01150903|141669559|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||Chi-square test was used to calculate p-value.||||<0.001
71081368|NCT01150903|141669560|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||Chi-square test was used to calculate p-value.||||<0.001
71081369|NCT05446142|141669584|OTHER||Reference/Test Ratio|95.25|||||TWO_SIDED|90.0|90.82|99.9||||||Natural log transformed encorafenib AUCinf was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||99.90|90.82|
71081370|NCT05446142|141669584|OTHER||Reference/Test Ratio|96.3|||||TWO_SIDED|90.0|91.71|101.12||||||Natural log transformed encorafenib AUCinf was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||101.12|91.71|
71081371|NCT05446142|141669584|OTHER||Reference/Test Ratio|96.57|||||TWO_SIDED|90.0|82.91|112.47||||||Natural log transformed encorafenib AUCinf was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to eMCC with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to eMCC with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||112.47|82.91|
71120906|NCT02305849|141747729|SUPERIORITY||Percent Difference|45.5|||<|0.001|TWO_SIDED|95.0|36.2|54.8||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||54.8|36.2|<0.001
70944003|NCT01568112|141388068|SUPERIORITY_OR_OTHER||Difference in percentage|-17.0|||||TWO_SIDED|95.0|-38.1|6.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||6.5|-38.1|
70944004|NCT01568112|141388068|SUPERIORITY_OR_OTHER||Difference in percentage|-11.0|||||TWO_SIDED|95.0|-34.2|12.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||12.2|-34.2|
71081372|NCT05446142|141669584|OTHER||Reference/Test Ratio|88.56|||||TWO_SIDED|90.0|82.59|94.95||||||Natural log transformed encorafenib AUCinf was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to eMCCL with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to eMCCL with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||94.95|82.59|
70944005|NCT01568112|141388068|SUPERIORITY_OR_OTHER||Difference in percentage|-20.0|||||TWO_SIDED|95.0|-40.6|3.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||3.8|-40.6|
70944006|NCT01568112|141388068|SUPERIORITY_OR_OTHER||Difference in percentage|-18.0|||||TWO_SIDED|95.0|-40.2|5.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||5.5|-40.2|
70944007|NCT01568112|141388069|SUPERIORITY_OR_OTHER||Mean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-3.0|-0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||-0.9|-3.0|
70944008|NCT01568112|141388069|SUPERIORITY_OR_OTHER||Mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|0.2|2.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||2.3|0.2|
70944009|NCT01568112|141388069|SUPERIORITY_OR_OTHER||Mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-3.2|-1.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||-1.2|-3.2|
70944010|NCT01568112|141388069|SUPERIORITY_OR_OTHER||Mean difference|1.3|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|0.1|2.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||2.5|0.1|
71081373|NCT05446142|141669585|OTHER||Reference/Test Ratio|104.31|||||TWO_SIDED|90.0|91.4|119.04||||||Natural log transformed encorafenib Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||119.04|91.40|
71081374|NCT05446142|141669585|OTHER||Reference/Test Ratio|90.35|||||TWO_SIDED|90.0|79.17|103.12||||||Natural log transformed encorafenib Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||103.12|79.17|
71120907|NCT02305849|141747731|SUPERIORITY||Percent Difference|42.4|||<|0.001|TWO_SIDED|95.0|32.3|52.5||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected|Treatment Difference vs Placebo||52.5|32.3|<0.001
70944011|NCT01568112|141388069|SUPERIORITY_OR_OTHER||Mean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|95.0|-2.8|-0.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||-0.7|-2.8|
70944012|NCT01568112|141388069|SUPERIORITY_OR_OTHER||Mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|0.1|2.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||2.3|0.1|
70944013|NCT01568112|141388069|SUPERIORITY_OR_OTHER||Mean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-2.7|-0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||-0.9|-2.7|
70944014|NCT01568112|141388069|SUPERIORITY_OR_OTHER||Mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-0.4|1.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||1.6|-0.4|
70944015|NCT01568112|141388069|SUPERIORITY_OR_OTHER||Mean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-2.8|-1.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||-1.0|-2.8|
70944016|NCT01568112|141388069|SUPERIORITY_OR_OTHER||Mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|0.2|2.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||2.2|0.2|
70944017|NCT01568112|141388070|SUPERIORITY_OR_OTHER||Mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-1.7|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||0.8|-1.7|
70944018|NCT01568112|141388070|SUPERIORITY_OR_OTHER||Mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|95.0|-1.8|0.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||0.4|-1.8|
70944019|NCT01568112|141388070|SUPERIORITY_OR_OTHER||Mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-2.0|0.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||0.6|-2.0|
71081375|NCT05446142|141669585|OTHER||Reference/Test Ratio|79.66|||||TWO_SIDED|90.0|58.7|108.08||||||Natural log transformed encorafenib Cmax was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to eMCC with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to eMCC with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||108.08|58.70|
71120908|NCT02305849|141747731|SUPERIORITY||Percent Difference|49.3|||<|0.001|TWO_SIDED|95.0|39.7|58.9||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected|Treatment Difference vs Placebo||58.9|39.7|<0.001
71120909|NCT02305849|141747733|SUPERIORITY||Percent Difference|19.7|||<|0.001|TWO_SIDED|95.0|12.1|27.3|||Fisher Exact|No multiplicity adjustment.|CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||27.3|12.1|<0.001
71120910|NCT02305849|141747733|SUPERIORITY||Percent Difference|30.4|||<|0.001|TWO_SIDED|95.0|22.0|38.7||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||38.7|22.0|<0.001
70855235|NCT02880956|141198380|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.072||0.125|TWO_SIDED|95.0|-0.251|0.031||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.031|-0.251|0.125
70944020|NCT01568112|141388070|SUPERIORITY_OR_OTHER||Mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-1.9|0.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||0.5|-1.9|
70944021|NCT01568112|141388070|SUPERIORITY_OR_OTHER||Mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|95.0|-2.0|0.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||0.4|-2.0|
70944022|NCT01568112|141388070|SUPERIORITY_OR_OTHER||Mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-2.1|0.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||0.2|-2.1|
70944023|NCT01568112|141388070|SUPERIORITY_OR_OTHER||Mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|95.0|-2.2|0.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||0.1|-2.2|
70944024|NCT01568112|141388070|SUPERIORITY_OR_OTHER||Mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-2.2|0.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||-0.0|-2.2|
70944025|NCT01568112|141388070|SUPERIORITY_OR_OTHER||Mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-2.1|0.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||0.4|-2.1|
70944026|NCT01568112|141388070|SUPERIORITY_OR_OTHER||Mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.58|||TWO_SIDED|95.0|-2.4|-0.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||-0.1|-2.4|
70944027|NCT01568112|141388071|SUPERIORITY_OR_OTHER||Difference in percentage|-12.0|||||TWO_SIDED|95.0|-32.2|9.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||9.5|-32.2|
71081376|NCT05446142|141669585|OTHER||Reference/Test Ratio|80.78|||||TWO_SIDED|90.0|64.82|100.68||||||Natural log transformed encorafenib Cmax was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to eMCCL with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to eMCCL with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||100.68|64.82|
71081377|NCT05446142|141669586|OTHER||Reference/Test Ratio|95.34|||||TWO_SIDED|90.0|90.37|100.59||||||Natural log transformed encorafenib AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||100.59|90.37|
71081378|NCT05446142|141669586|OTHER||Reference/Test Ratio|94.67|||||TWO_SIDED|90.0|89.73|99.88||||||Natural log transformed encorafenib AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||99.88|89.73|
71081379|NCT05446142|141669586|OTHER||Reference/Test Ratio|95.76|||||TWO_SIDED|90.0|84.1|109.04||||||Natural log transformed encorafenib AUClast was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to eMCC with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to eMCC with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||109.04|84.10|
71120911|NCT02305849|141747735|SUPERIORITY||Percent Difference|42.5|||<|0.001|TWO_SIDED|95.0|32.3|52.6||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||52.6|32.3|<0.001
70944028|NCT01568112|141388071|SUPERIORITY_OR_OTHER||Difference in percentage|7.0|||||TWO_SIDED|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||27.8|-14.1|
70944029|NCT01568112|141388072|SUPERIORITY_OR_OTHER||Difference in percentage|-22.0|||||TWO_SIDED|95.0|-41.0|0.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||0.1|-41.0|
70944030|NCT01568112|141388072|SUPERIORITY_OR_OTHER||Difference in percentage|7.0|||||TWO_SIDED|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||27.8|-14.1|
70944031|NCT01568112|141388073|SUPERIORITY_OR_OTHER||Difference in percentage|-20.0|||||TWO_SIDED|95.0|-40.6|3.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||3.8|-40.6|
70944032|NCT01568112|141388073|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0|||||TWO_SIDED|95.0|-24.7|21.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||21.7|-24.7|
70944033|NCT01568112|141388074|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-22.0|22.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||22.0|-22.0|
70944034|NCT01568112|141388074|SUPERIORITY_OR_OTHER||Difference in percentage|4.0|||||TWO_SIDED|95.0|-16.4|25.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||25.5|-16.4|
71081380|NCT05446142|141669586|OTHER||Reference/Test Ratio|88.31|||||TWO_SIDED|90.0|82.36|94.7||||||Natural log transformed encorafenib AUClast was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to eMCCL with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to eMCCL with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||94.70|82.36|
71120912|NCT02305849|141747735|SUPERIORITY||Percent Difference|47.0|||<|0.001|TWO_SIDED|95.0|37.1|56.9||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||56.9|37.1|<0.001
70855236|NCT02880956|141198380|SUPERIORITY||Effect size/pooled SD|0.21|STANDARD_DEVIATION|0.53|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855237|NCT02880956|141198380|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.074||0.676|TWO_SIDED|95.0|-0.176|0.114||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||week 48||0.114|-0.176|0.676
70944035|NCT01568112|141388075|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0|||||TWO_SIDED|95.0|-24.2|19.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||19.7|-24.2|
71081381|NCT02098395|141669595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|||<|0.0001|TWO_SIDED|95.0|-0.5|-0.2|||Mixed Models Analysis|||Superiority of liraglutide 1.8 mg versus placebo was planned to be concluded if and only if the upper limit of the two-sided 95% confidence interval for the estimated difference in HbA1c was less than zero.||-0.2|-0.5|< 0.0001
71081382|NCT02098395|141669595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|||=|0.0021|TWO_SIDED|95.0|-0.38|-0.08|||Mixed Models Analysis|||Superiority of liraglutide 1.2 mg was planned to be evaluated only if superiority for liraglutide 1.8 mg was concluded.||-0.08|-0.38|= 0.0021
71081383|NCT02098395|141669595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|||=|0.0011|TWO_SIDED|95.0|-0.39|-0.1|||Mixed Models Analysis|||Superiority of liraglutide 0.6 mg versus placebo was planned to be evaluated only if superiority of liraglutide 1.2 mg was concluded.||-0.1|-0.39|= 0.0011
71081384|NCT00547157|141669600|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.09|||||TWO_SIDED|95.0|-0.26|0.07|||||difference is PRT - CRT|||0.07|-0.26|
71081385|NCT00547157|141669601|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.613||||0.0601|TWO_SIDED|95.0|0.98|2.656|||Regression, Cox||Hazard ratio is presented as panitumumab plus radiotherapy:chemoradiotherapy.|||2.656|0.980|0.0601
71120913|NCT02305849|141747737|SUPERIORITY||Percent Difference|5.2||||0.011|TWO_SIDED|95.0|1.0|9.5||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||9.5|1.0|0.011
71120914|NCT02305849|141747737|SUPERIORITY||Percent Difference|9.3|||<|0.001|TWO_SIDED|95.0|4.1|14.6||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||14.6|4.1|<0.001
71120915|NCT02305849|141747739|SUPERIORITY|No multiplicity adjustment.|Percent Difference|6.4||||0.003|TWO_SIDED|95.0|1.8|11.0|||Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||11.0|1.8|0.003
70855238|NCT02880956|141198380|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|0.61|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855239|NCT02880956|141198380|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.095||0.226|TWO_SIDED|95.0|-0.301|0.071||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.071|-0.301|0.226
70855240|NCT02880956|141198380|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|0.62|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70944036|NCT01568112|141388075|SUPERIORITY_OR_OTHER||Difference in percentage|-3.0|||||TWO_SIDED|95.0|-23.3|18.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||18.7|-23.3|
71081386|NCT00547157|141669602|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.731||||0.0259|TWO_SIDED|95.0|1.068|2.806|||Regression, Cox||Hazard ratio is presented as panitumumab plus radiotherapy:chemoradiotherapy.|||2.806|1.068|0.0259
71081387|NCT00547157|141669603|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.593||||0.1039|TWO_SIDED|95.0|0.909|2.793|||Regression, Cox||Hazard ratio is presented as panitumumab plus radiotherapy:chemoradiotherapy|||2.793|0.909|0.1039
71081388|NCT00547157|141669604|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.791||||0.5744|TWO_SIDED|95.0|0.342|1.785|||Regression, Logistic||The odd ratio is defined as the odds of having an objective response in the panitumumab plus radiotherapy arm relative to the odds in the chemoradiotherapy arm.|||1.785|0.342|0.5744
71081389|NCT00547157|141669604|SUPERIORITY_OR_OTHER||Difference in objective response rate|-0.044|||||TWO_SIDED|95.0|-0.187|0.112|||||Difference is objective response rate in the panitumumab plus radiotherapy arm minus the rate in the chemoradiotherapy arm.|||0.112|-0.187|
71081390|NCT00547157|141669605|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.278||||0.807|TWO_SIDED|95.0|0.438|4.043|||Regression, Logistic||The odd ratio is defined as the odds of having an objective response in the panitumumab plus radiotherapy arm relative to the odds in the chemoradiotherapy arm.|||4.043|0.438|0.8070
71081391|NCT00547157|141669605|SUPERIORITY_OR_OTHER||Difference in complete response rate|0.029|||||TWO_SIDED|95.0|-0.103|0.141|||||Difference is objective response rate in the panitumumab plus radiotherapy arm minus the rate in the chemoradiotherapy arm.|||0.141|-0.103|
71081392|NCT01151345|141669655|SUPERIORITY_OR_OTHER||Adjusted geometric means ratio|88.65|||||TWO_SIDED|90.0|81.23|96.75||||||Natural-log transformed AUC (0-t) was analyzed using a mixed effect model with sequence, period, and treatment as fixed effects and participant within sequence as a random effect.||96.75|81.23|
71081393|NCT01151345|141669656|SUPERIORITY_OR_OTHER||Adjusted geometric means ratio|91.26|||||TWO_SIDED|90.0|83.83|99.34||||||Natural-log transformed AUC (0-∞) was analyzed using a mixed effect model with sequence, period, and treatment as fixed effects and participant within sequence as a random effect.||99.34|83.83|
71081394|NCT01151345|141669657|SUPERIORITY_OR_OTHER||Adjusted geometric means ratio|83.25|||||TWO_SIDED|90.0|67.08|103.31||||||Natural-log transformed Cmax was analyzed using a mixed effect model with sequence, period, and treatment as fixed effects and participant within sequence as a random effect.||103.31|67.08|
71120916|NCT02305849|141747739|SUPERIORITY||Percent Difference|13.4|||<|0.001|TWO_SIDED|95.0|7.5|19.4||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||19.4|7.5|<0.001
71120917|NCT02305849|141747741|SUPERIORITY||LS Mean Difference|-11.22|STANDARD_ERROR_OF_MEAN|1.33|<|0.001|TWO_SIDED|95.0|-13.84|-8.6||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SDAI Change = Treatment + Baseline SDAI.||Treatment Difference vs Placebo||-8.60|-13.84|<0.001
70944037|NCT01568112|141388076|SUPERIORITY_OR_OTHER||Difference in percentage|-7.0|||||TWO_SIDED|95.0|-29.4|17.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||17.1|-29.4|
70944038|NCT01568112|141388076|SUPERIORITY_OR_OTHER||Difference in percentage|1.0|||||TWO_SIDED|95.0|-22.1|24.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||24.5|-22.1|
70944039|NCT01568112|141388077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-1.1|1.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||1.1|-1.1|
70944040|NCT01568112|141388077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-1.1|0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||0.9|-1.1|
70944041|NCT01568112|141388077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|95.0|-1.4|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||0.8|-1.4|
70944042|NCT01568112|141388077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.7|0.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||0.1|-1.7|
70944043|NCT01568112|141388077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-0.5|1.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||1.6|-0.5|
70944044|NCT01568112|141388077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-0.7|1.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||1.3|-0.7|
70944045|NCT01568112|141388077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|95.0|-1.0|0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||0.9|-1.0|
71081395|NCT00099632|141669667|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by ARV regimen and the actual receipt of antenatal ZDV||Compare proportion of women with new NNRTI-resistant variants between treatment durations (7-day vs. 21 day), pooled over ARV regimens (3TC/ZDV, FTC/TDF, and LPV/r), stratified by ARV regimen and the actual receipt of antenatal ZDV||||0.37
71081396|NCT00099632|141669667|SUPERIORITY_OR_OTHER_LEGACY|||||||0.091||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by treatment duration and the actual receipt of antenatal ZDV||Compare proportion of women with new NNRTI-resistant variants among ARV regimens (3TC/ZDV vs. FTC/TDF vs. LPV/r), pooled over treatment durations 7-day and 21-day, stratified by treatment duration and the actual receipt of antenatal ZDV||||0.091
71120918|NCT02305849|141747741|SUPERIORITY||LS Mean Difference|-14.67|STANDARD_ERROR_OF_MEAN|1.36|<|0.001|TWO_SIDED|95.0|-17.35|-11.98||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SDAI Change = Treatment + Baseline SDAI.||Treatment Difference vs Placebo||-11.98|-17.35|<0.001
71120919|NCT02305849|141747743|SUPERIORITY||LS Mean difference|-17.67|STANDARD_ERROR_OF_MEAN|2.26|<|0.001|TWO_SIDED|95.0|-22.11|-13.22||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: PGA (100 mm VAS) Change = Treatment + Baseline PGA (100 mm VAS).||Treatment Difference vs Placebo||-13.22|-22.11|<0.001
71120920|NCT02305849|141747743|SUPERIORITY||LS Mean Difference|-24.09|STANDARD_ERROR_OF_MEAN|2.33|<|0.001||95.0|-28.66|-19.51||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: PGA (100 mm VAS) Change = Treatment + Baseline PGA (100 mm VAS).||Treatment Difference vs Placebo||-19.51|-28.66|<0.001
70944046|NCT01568112|141388077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.1|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||0.8|-1.1|
70944047|NCT01568112|141388077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-0.6|0.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||0.7|-0.6|
70944048|NCT01568112|141388077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.6|0.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||0.5|-0.6|
70944049|NCT01568112|141388077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-1.0|0.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||0.3|-1.0|
70944050|NCT01568112|141388077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-0.8|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||0.8|-0.8|
70944051|NCT01568112|141388077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.0|0.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||0.6|-1.0|
70944052|NCT01568112|141388077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-0.8|0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||0.9|-0.8|
71081397|NCT02432209|141669672|SUPERIORITY||Risk Ratio (RR)|0.81||||0.404|TWO_SIDED|95.0|0.48|1.34|||Chi-squared|||||1.34|0.48|0.404
71081398|NCT01087203|141669709|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) mean difference|-1.22|STANDARD_ERROR_OF_MEAN|0.53||0.025|TWO_SIDED|95.0|-2.28|-0.16|||ANCOVA|||Analysis of Covariance (ANCOVA) model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||-0.16|-2.28|0.025
71081399|NCT01087203|141669710|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.332|TWO_SIDED|95.0|-0.92|0.32|||ANCOVA|||Week 1: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||0.32|-0.92|0.332
71120921|NCT02305849|141747745|SUPERIORITY||LS Mean Difference|-16.64|STANDARD_ERROR_OF_MEAN|2.26|<|0.001|TWO_SIDED|95.0|-21.09|-12.19||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SGA (100 mm VAS) Change = Treatment + Baseline SGA (100 mm VAS)||Treatment Difference vs Placebo||-12.19|-21.09|<0.001
71081400|NCT01087203|141669710|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.38||0.297|TWO_SIDED|95.0|-1.15|0.36|||ANCOVA|||Week 2: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||0.36|-1.15|0.297
71081401|NCT01087203|141669710|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.95|STANDARD_ERROR_OF_MEAN|0.42||0.029|TWO_SIDED|95.0|-1.81|-0.1|||ANCOVA|||Week 4: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||-0.10|-1.81|0.029
71081402|NCT01087203|141669710|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.24|STANDARD_ERROR_OF_MEAN|0.46||0.01|TWO_SIDED|95.0|-2.17|-0.3|||ANCOVA|||Week 6: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||-0.30|-2.17|0.010
71120922|NCT02305849|141747745|SUPERIORITY||LS Mean difference|-20.34|STANDARD_ERROR_OF_MEAN|2.4|<|0.001|TWO_SIDED|95.0|-25.07|-15.61||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SGA (100 mm VAS) Change = Treatment + Baseline SGA (100 mm VAS).||Treatment Difference vs Placebo||-15.61|-25.07|<0.001
70855241|NCT02880956|141198380|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.093||0.683|TWO_SIDED|95.0|-0.222|0.145||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.145|-0.222|0.683
71120923|NCT02305849|141747747|SUPERIORITY||LS Mean Difference|-17.19|STANDARD_ERROR_OF_MEAN|2.44|<|0.001|TWO_SIDED|95.0|-22.0|-12.38||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SGAP (100 mm VAS) Change = Treatment + Baseline SGAP (100 mm VAS).||Treatment Difference vs Placebo||-12.38|-22.00|<0.001
71120924|NCT02305849|141747747|SUPERIORITY||LS Mean difference|-20.89|STANDARD_ERROR_OF_MEAN|2.5|<|0.001|TWO_SIDED|95.0|-25.8|-15.98||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SGAP (100 mm VAS) Change = Treatment + Baseline SGAP (100 mm VAS).||Treatment Difference vs Placebo||-15.98|-25.80|<0.001
70855242|NCT02880956|141198380|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|0.63|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71120925|NCT02305849|141747750|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.36|-0.17||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: HAQ-DI Change = Treatment + Baseline HAQ-DI.||Treatment Difference vs Placebo||-0.17|-0.36|<0.001
70944053|NCT01568112|141388077|SUPERIORITY_OR_OTHER||Difference in percentage|0.2|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-0.7|1.1||||||Bloating||1.1|-0.7|
71081403|NCT01087203|141669710|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.32|STANDARD_ERROR_OF_MEAN|0.49||0.009|TWO_SIDED|95.0|-2.3|-0.34|||ANCOVA|||Week 8: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||-0.34|-2.30|0.009
71081404|NCT01087203|141669710|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.31|STANDARD_ERROR_OF_MEAN|0.52||0.015|TWO_SIDED|95.0|-2.36|-0.27|||ANCOVA|||Week 12: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||-0.27|-2.36|0.015
71081405|NCT02182830|141669750|SUPERIORITY|A hierarchical multiple testing procedure was used to evaluate superiority of the primary endpoint|Adjusted mean difference|-0.78|STANDARD_ERROR_OF_MEAN|0.2||0.0002|TWO_SIDED|95.0|-1.18|-0.38|||Mixed Models Analysis||Empagliflozin minus Placebo|"MMRM model : HbA1c baseline, treatment, renal function, pre-treatment with metformin, visit, visit by treatment interaction, and HbA1c baseline by treatment interaction. Treatment, renal function, pre-treatment with metformin, visit, and visit by treatment interaction were fixed classification effects, and HbA1c baseline was a linear covariate. The interaction visit by HbA1c baseline interaction was based on the linear covariate HbA1c baseline."||-0.38|-1.18|0.0002
70855243|NCT02880956|141198380|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.094||0.848|TWO_SIDED|95.0|-0.168|0.204||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.204|-0.168|0.848
71120926|NCT02305849|141747750|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.48|-0.29||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: HAQ-DI Change = Treatment + Baseline HAQ-DI.||Treatment Difference vs Placebo||-0.29|-0.48|<0.001
71120927|NCT02305849|141747752|SUPERIORITY||LS Mean Difference|6.41|STANDARD_ERROR_OF_MEAN|1.18|<|0.001|TWO_SIDED|95.0|4.09|8.74||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.||Treatment Difference vs Placebo||8.74|4.09|<0.001
71120928|NCT02305849|141747752|SUPERIORITY||LS Mean Difference|8.61|STANDARD_ERROR_OF_MEAN|1.14|<|0.001|TWO_SIDED|95.0|6.36|10.86||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.||Treatment Difference vs Placebo||10.86|6.36|<0.001
71120929|NCT02305849|141747754|SUPERIORITY||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|0.76|<|0.001|TWO_SIDED|95.0|1.21|4.18||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.||Treatment Difference vs Placebo||4.18|1.21|<0.001
71120930|NCT02305849|141747754|SUPERIORITY||LS Mean Difference|1.65|STANDARD_ERROR_OF_MEAN|0.78||0.036|TWO_SIDED|95.0|0.11|3.19||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.||Treatment Difference vs Placebo||3.19|0.11|0.036
71120931|NCT02305849|141747756|SUPERIORITY||LS Mean Difference|2.29|STANDARD_ERROR_OF_MEAN|1.39||0.099|TWO_SIDED|95.0|-0.44|5.02||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.||Treatment Difference vs Placebo||5.02|-0.44|0.099
71120932|NCT02305849|141747756|SUPERIORITY||LS Mean Difference|4.22|STANDARD_ERROR_OF_MEAN|1.37||0.002|TWO_SIDED|95.0|1.53|6.91||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.||Treatment Difference vs Placebo||6.91|1.53|0.002
71120933|NCT02305849|141747758|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|2.43||0.879|TWO_SIDED|95.0|-5.16|4.42||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||4.42|-5.16|0.879
71120934|NCT02305849|141747758|SUPERIORITY||LS Mean Difference|-1.81|STANDARD_ERROR_OF_MEAN|2.05||0.377|TWO_SIDED|95.0|-5.86|2.23||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||2.23|-5.86|0.377
71120935|NCT02305849|141747760|SUPERIORITY||LS Mean Difference|-9.63|STANDARD_ERROR_OF_MEAN|3.5||0.007|TWO_SIDED|95.0|-16.54|-2.73||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||-2.73|-16.54|0.007
71120936|NCT02305849|141747760|SUPERIORITY||LS Mean Difference|-14.17|STANDARD_ERROR_OF_MEAN|3.58|<|0.001|TWO_SIDED|95.0|-21.24|-7.1||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||-7.10|-21.24|<0.001
71120937|NCT02305849|141747762|SUPERIORITY||LS Mean Difference|-9.43|STANDARD_ERROR_OF_MEAN|3.63||0.01|TWO_SIDED|95.0|-16.6|-2.25||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||-2.25|-16.60|0.010
71120938|NCT02305849|141747762|SUPERIORITY||LS Mean Difference|-14.61|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-21.92|-7.31||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||-7.31|-21.92|<0.001
71120939|NCT02305849|141747764|SUPERIORITY||LS Mean Difference|-13.19|STANDARD_ERROR_OF_MEAN|2.56|<|0.001|TWO_SIDED|95.0|-18.23|-8.16||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||-8.16|-18.23|<0.001
71120940|NCT02305849|141747764|SUPERIORITY||LS Mean Difference|-17.61|STANDARD_ERROR_OF_MEAN|2.52|<|0.001|TWO_SIDED|95.0|-22.57|-12.66||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||-12.66|-22.57|<0.001
71120941|NCT02818036|141747793|OTHER|difference in neural activity to social task when taking naltrexone as compared to placebo|||||<|0.01||||||a priori threshold for significance was p\<.05|t-test, 1 sided|degrees of freedom = 75||||||<.01
71120942|NCT02818036|141747794|OTHER|differences in feelings of social connection between those who took naltrexone and those who took placebo||||||0.338||||||a priori threshold for statistical significance was p\<.05|t-test, 2 sided|||||||.338
71120943|NCT01038713|141747798|SUPERIORITY_OR_OTHER|||||||0.22||||||Analysis comparing the number of patients who had stent occlusion|Chi-squared|3 x 2 contingency table comparing all three groups||||||0.22
71120944|NCT01038713|141747798|SUPERIORITY_OR_OTHER|||||||0.14|||||||Chi-squared|3 x 2 contingency table comparing all three groups||Analysis comparing the rate of attempted surgical resection||||0.14
71120945|NCT01038713|141747798|SUPERIORITY_OR_OTHER|||||||0.96|||||||Chi-squared|3 x 2 contingency table comparing all three groups||Analysis comparing the rate of death between groups||||0.96
71120946|NCT01038713|141747799|SUPERIORITY_OR_OTHER|||||||1|||||||ANOVA|||||||1.00
71120947|NCT03777917|141747807|SUPERIORITY||Difference in Response Rates|72.1|||<|0.0001|TWO_SIDED|95.0|47.5|83.5|||Fisher Exact|The Fisher's exact test was used to test for the superiority of treatment (Belotero Balance®) over control.|Two-sided Newcombe confidence interval (CI) for the difference in response rates.|||83.5|47.5|< 0.0001
71120948|NCT00042432|141747813|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.67||||0.006||95.0|1.6|20.06|||Cochran-Mantel-Haenszel|Adjusted for baseline glomenular filtration rate (GFR) strata|Logit estimates|||20.06|1.60|0.006
71120949|NCT00042432|141747814|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|Adusted for baseline glomerular filtration rate (GFR) strata||||||<0.001
71120950|NCT01853072|141747815|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|1.5|3.0|||Regression, Logistic||Parameter dispersion is the standard error for the odds ratio.|This endpoint was considered primary for United States (US) registration and secondary for European Union (EU) registration.||3.0|1.5|<0.001
71120951|NCT01853072|141747816|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|0.1|0.3|||Regression, Logistic||Parameter dispersion is the standard error for the odds ratio.|This endpoint was considered primary for EU registration and secondary for US registration.||0.3|0.1|<0.001
70855244|NCT02880956|141198380|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|0.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855245|NCT02880956|141198380|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.126||0.656|TWO_SIDED|95.0|-0.305|0.192||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.192|-0.305|0.656
70855246|NCT02880956|141198380|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|0.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71120952|NCT01527383|141747846|OTHER||||||<|0.0001|||||||Longitudinal regression|Visit and stratification factor (biologic or non-biologic autoimmune therapy) were covariates|||The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is \>1.0.|||<0.0001
70855247|NCT02880956|141198380|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.124||0.777|TWO_SIDED|95.0|-0.279|0.209||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.209|-0.279|0.777
70855248|NCT02880956|141198380|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|0.88|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855249|NCT02880956|141198380|SUPERIORITY||LS Mean of Difference|0.15|STANDARD_ERROR_OF_MEAN|0.128||0.256|TWO_SIDED|95.0|-0.106|0.397||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.397|-0.106|0.256
70855250|NCT02880956|141198380|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|0.89|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855251|NCT02880956|141198381|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.101||0.479|TWO_SIDED|95.0|-0.269|0.126||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.126|-0.269|0.479
70944054|NCT01568112|141388077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-0.9|0.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||0.7|-0.9|
71120953|NCT01527383|141747847|OTHER||||||<|0.0001|||||||Longitudinal regression|Visit and stratification factor (biologic or non-biologic autoimmune therapy) were covariates|||The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is \>1.0.|||<0.0001
71120954|NCT01287221|141747866|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.82
71120955|NCT01287221|141747867|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.62
71120956|NCT01287221|141747868|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.23
71120957|NCT01287221|141747869|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.31
71120958|NCT01287221|141747870|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.65
71120959|NCT01287221|141747871|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.61
70855252|NCT02880956|141198381|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|0.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855253|NCT02880956|141198381|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.099||0.295|TWO_SIDED|95.0|-0.299|0.091||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.091|-0.299|0.295
70855254|NCT02880956|141198381|SUPERIORITY||Effect size/pooled SD|0.13|STANDARD_DEVIATION|0.77|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855255|NCT02880956|141198381|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.102||0.884|TWO_SIDED|95.0|-0.186|0.215||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.215|-0.186|0.884
70944055|NCT01568112|141388077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-0.8|0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||0.9|-0.8|
70855256|NCT02880956|141198381|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|0.83|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855257|NCT02880956|141198381|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.111||0.569|TWO_SIDED|95.0|-0.281|0.155||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.155|-0.281|0.569
70855258|NCT02880956|141198381|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|0.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855259|NCT02880956|141198381|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_ERROR_OF_MEAN|0.108||0.702|TWO_SIDED|95.0|-0.254|0.171||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.171|-0.254|0.702
70855260|NCT02880956|141198381|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|0.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855261|NCT02880956|141198381|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.111||0.566|TWO_SIDED|95.0|-0.155|0.283||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.283|-0.155|0.566
70855262|NCT02880956|141198381|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|0.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855263|NCT02880956|141198381|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.133||0.141|TWO_SIDED|95.0|-0.458|0.065||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.065|-0.458|0.141
70855264|NCT02880956|141198381|SUPERIORITY||Effect size/pooled SD|0.22|STANDARD_DEVIATION|0.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855265|NCT02880956|141198381|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.131||0.834|TWO_SIDED|95.0|-0.285|0.23||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.230|-0.285|0.834
70855266|NCT02880956|141198381|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|0.99|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855267|NCT02880956|141198381|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.133||0.724|TWO_SIDED|95.0|-0.309|0.215||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.215|-0.309|0.724
70855268|NCT02880956|141198381|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|1.0|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855269|NCT02880956|141198381|SUPERIORITY||LS Mean of Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.166||0.163|TWO_SIDED|95.0|-0.559|0.095||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.095|-0.559|0.163
70855270|NCT02880956|141198381|SUPERIORITY||Effect size/pooled SD|0.24|STANDARD_DEVIATION|0.98|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855271|NCT02880956|141198381|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.163||0.497|TWO_SIDED|95.0|-0.432|0.21||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.210|-0.432|0.497
71120960|NCT01287221|141747872|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.22
71120961|NCT00657150|141747878|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 7.7%|Risk Difference (Percentage)|-1.08|||<|0.0001||95.0|-3.79|1.64||Superiority p-value = 0.4367|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||1.64|-3.79|< 0.0001
70855272|NCT02880956|141198381|SUPERIORITY||effect size|0.1|STANDARD_DEVIATION|1.09|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855273|NCT02880956|141198381|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.168||0.919|TWO_SIDED|95.0|-0.314|0.349||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.349|-0.314|0.919
70855274|NCT02880956|141198381|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|1.17|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855275|NCT02880956|141198382|SUPERIORITY||LS Mean of Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.352||0.423|TWO_SIDED|95.0|-0.974|0.409||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.409|-0.974|0.423
70855276|NCT02880956|141198382|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|3.09|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71120962|NCT00657150|141747879|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.91||||0.029||95.0|-3.64|-0.19|||Normal approximation|Normal approximation of independent binomial distribution without stratification||||-0.19|-3.64|0.029
71081406|NCT02182830|141669751|SUPERIORITY|A hierarchical multiple testing procedure was used to evaluate superiority of the endpoint|Adjusted mean difference|-5.21|STANDARD_ERROR_OF_MEAN|2.04||0.0117|TWO_SIDED|95.0|-9.24|-1.18|||ANCOVA||Empagliflozin minus Placebo|"change from baseline in mean 24-hour ambulatory SBP at 12 weeks of treatment was evaluated by using an Analysis of Covariance (ANCOVA) model.~The respective model included treatment, renal function, pretreatment with metformin, continuous baseline HbA1c, and continuous baseline of the endpoint."||-1.18|-9.24|0.0117
71081407|NCT02182830|141669752|SUPERIORITY|A hierarchical multiple testing procedure was used to evaluate superiority of the endpoint|Adjusted mean difference|-5.99|STANDARD_ERROR_OF_MEAN|2.62||0.0237|TWO_SIDED|95.0|-11.16|-0.81|||ANCOVA||Empagliflozin minus Placebo|"ANCOVA mode:~The respective model included treatment, renal function, pretreatment with metformin, continuous baseline HbA1c, and continuous baseline of the endpoint."||-0.81|-11.16|0.0237
71081408|NCT02182830|141669753|SUPERIORITY|A hierarchical multiple testing procedure was used to evaluate superiority of the endpoint|Adjusted mean difference|-1.23|STANDARD_ERROR_OF_MEAN|0.59||0.0382|TWO_SIDED|95.0|-2.39|-0.07|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the key secondary endpoint with continuous baseline HbA1c, continuous baseline key secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline key secondary endpoint.||-0.07|-2.39|0.0382
71120963|NCT00657150|141747880|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-1.79||||0.0358||95.0|-3.47|-0.12|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||-0.12|-3.47|0.0358
71120964|NCT00657150|141747881|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.96||||0.4839|TWO_SIDED|95.0|-3.65|1.73|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||1.73|-3.65|0.4839
71120965|NCT00657150|141747882|SUPERIORITY_OR_OTHER|||||||0.0612||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.0612
71120966|NCT00657150|141747883|SUPERIORITY_OR_OTHER|||||||0.6231||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.6231
70855277|NCT02880956|141198382|SUPERIORITY||LS Mean of Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.346||0.036|TWO_SIDED|95.0|-1.408|-0.047||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||-0.047|-1.408|0.036
70855278|NCT02880956|141198382|SUPERIORITY||Effect size/pooled SD|0.25|STANDARD_DEVIATION|2.96|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855279|NCT02880956|141198382|SUPERIORITY||LS Mean of Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.355||0.121|TWO_SIDED|95.0|-1.25|0.147||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.147|-1.250|0.121
70855280|NCT02880956|141198382|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|3.09|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855281|NCT02880956|141198382|SUPERIORITY||LS Mean of Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.371||0.244|TWO_SIDED|95.0|-1.163|0.296||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.296|-1.163|0.244
70855282|NCT02880956|141198382|SUPERIORITY||Effect size/pooled SD|0.15|STANDARD_DEVIATION|2.88|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71081409|NCT02182830|141669754|SUPERIORITY|A hierarchical multiple testing procedure was used to evaluate superiority of the endpoint|Adjusted mean difference|-4.04|STANDARD_ERROR_OF_MEAN|2.59||0.1215|TWO_SIDED|95.0|-9.16|1.09|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the key secondary endpoint with continuous baseline HbA1c, continuous baseline key secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline key secondary endpoint.||1.09|-9.16|0.1215
71120967|NCT00657150|141747884|SUPERIORITY_OR_OTHER|||||||0.4977||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.4977
71120968|NCT00657150|141747885|SUPERIORITY_OR_OTHER|||||||0.687||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.6870
71120969|NCT00657150|141747886|SUPERIORITY_OR_OTHER|||||||0.4022||95.0|||||Fisher Exact|||Comparison versus Enoxaparin for the category major bleeding events||||0.4022
71120970|NCT00657150|141747886|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|0.8||||0.3305|TWO_SIDED|95.0|-0.8|2.3|||Normal approximation|Normal approximation of independent binomial distribution||Absolute difference versus Enoxaparin for the category major and clinically relevant bleeding events||2.3|-0.8|0.3305
71120971|NCT00657150|141747886|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|1.4||||0.2626|TWO_SIDED|95.0|-1.1|3.9|||Normal approximation|Normal approximation of independent binomial distribution||Absolute difference versus Enoxaparin for the category any bleeding events||3.9|-1.1|0.2626
71120972|NCT02649192|141747894|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG1 at day 56 in 2015-16 season||||0.90
71120973|NCT02649192|141747894|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG1 at day 56 in 2016-17 season||||0.49
71120974|NCT02649192|141747894|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG1 at day 56 in 2017-18 season||||0.50
70855283|NCT02880956|141198382|SUPERIORITY||LS Mean of Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.36||0.085|TWO_SIDED|95.0|-1.33|0.086||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.086|-1.330|0.085
70855284|NCT02880956|141198382|SUPERIORITY||Effect size/pooled SD|0.21|STANDARD_DEVIATION|3.03|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855285|NCT02880956|141198382|SUPERIORITY||LS Mean of Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.371||0.137|TWO_SIDED|95.0|-1.28|0.177||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.177|-1.280|0.137
70855286|NCT02880956|141198382|SUPERIORITY||Effect size/pooled SD|0.19|STANDARD_DEVIATION|2.85|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71081410|NCT02182830|141669755|SUPERIORITY||Adjusted mean difference|-8.39|STANDARD_ERROR_OF_MEAN|2.69||0.0025|TWO_SIDED|95.0|-13.74|-3.04|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.||-3.04|-13.74|0.0025
71081411|NCT02182830|141669756|SUPERIORITY||Adjusted mean difference|-3.43|STANDARD_ERROR_OF_MEAN|1.25||0.0069|TWO_SIDED|95.0|-5.9|-0.96|||ANCOVA||Empagliflozin minus Placebo|The respective ANCOVA model includes treatment, renal function, pretreatment with metformin, continuous baseline HbA1c, and continuous baseline of the respective secondary endpoint.||-0.96|-5.90|0.0069
71081412|NCT02182830|141669757|SUPERIORITY||Adjusted mean difference|-4.91|STANDARD_ERROR_OF_MEAN|1.74||0.0058|TWO_SIDED|95.0|-8.35|-1.46|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.||-1.46|-8.35|0.0058
71081413|NCT02182830|141669758|SUPERIORITY||Adjusted mean difference|-7.43|STANDARD_ERROR_OF_MEAN|2.5||0.0036|TWO_SIDED|95.0|-12.37|-2.48|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.||-2.48|-12.37|0.0036
71081414|NCT02182830|141669759|SUPERIORITY||Adjusted mean difference|-1.84|STANDARD_ERROR_OF_MEAN|1.56||0.2402|TWO_SIDED|95.0|-4.93|1.25|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.||1.25|-4.93|0.2402
71120975|NCT02649192|141747894|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG2 at day 56 in 2015-16 season||||0.90
70855287|NCT02880956|141198382|SUPERIORITY||LS Mean of Difference|0.4|STANDARD_ERROR_OF_MEAN|0.352||0.258|TWO_SIDED|95.0|-0.294|1.091||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.091|-0.294|0.258
70855288|NCT02880956|141198382|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|2.88|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855289|NCT02880956|141198382|SUPERIORITY||LS Mean of Difference|0.13|STANDARD_ERROR_OF_MEAN|0.348||0.711|TWO_SIDED|95.0|-0.555|0.814||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.814|-0.555|0.711
70855290|NCT02880956|141198382|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|3.05|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855291|NCT02880956|141198382|SUPERIORITY||LS Mean of Difference|0.24|STANDARD_ERROR_OF_MEAN|0.35||0.503|TWO_SIDED|95.0|-0.454|0.924||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.924|-0.454|0.503
71081415|NCT02182830|141669760|SUPERIORITY||Adjusted mean difference|-4.25|STANDARD_ERROR_OF_MEAN|1.49||0.0053|TWO_SIDED|95.0|-7.21|-1.29|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.||-1.29|-7.21|0.0053
71081416|NCT04672044|141669774|SUPERIORITY|||||||0.896|||||||Wilcoxon (Mann-Whitney)|||||||0.896
71081417|NCT00792116|141669786|NON_INFERIORITY_OR_EQUIVALENCE|||||||0.05||95.0|||||ANCOVA|Repeated Measures||||||.05
71081418|NCT00792116|141669787|NON_INFERIORITY_OR_EQUIVALENCE|||||||0.05||95.0|||||ANCOVA|Repeated Measures||||||.05
71120976|NCT02649192|141747894|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG2 at day 56 in 2016-17 season||||0.76
71120977|NCT02649192|141747894|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG2 at day 56 in 2017-18 season||||0.65
71120978|NCT02649192|141747894|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG3 at day 56 in 2015-16 season||||0.90
71120979|NCT02649192|141747894|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG3 at day 56 in 2016-17 season||||0.76
70855292|NCT02880956|141198382|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|2.99|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855293|NCT02880956|141198382|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.404||0.978|TWO_SIDED|95.0|-0.806|0.784||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.784|-0.806|0.978
70944056|NCT01568112|141388077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-0.7|1.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||1.1|-0.7|
70944057|NCT01568112|141388078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-1.0|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||0.8|-1.0|
71081419|NCT01680653|141669788|SUPERIORITY_OR_OTHER|||||||0.106||||||In analyzing prolonged events on remote monitoring versus control, we used x squared analysis or Fisher's exact test to analyze data on 2 x 2 contingency tables. Significance was defined as P\<0.05.|Wilcoxon (Mann-Whitney)|||The study was a feasibility and preliminary safety study. As such, the sample size was not statistically derived and the protocol was not powered to provide for definitive conclusions. The study was limited to 20 participants at each camp session. A hypoglycemic event was defined as at least two consecutive CGM readings (10 mins) below the hypoglycemic threshold of \<70 mg/dL. Recovery from a hypoglycemic event required readings above threshold for \> or = 25 minutes.||||0.106
71081420|NCT01680653|141669789|SUPERIORITY_OR_OTHER|||||||0.078|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.078
71081421|NCT01680653|141669790|SUPERIORITY_OR_OTHER||Fisher's exact test|||||0.003|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This is the P value for the number of events \<70 mg/dL longer than one hour||||0.003
71081422|NCT01680653|141669790|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Fisher's exact test|||This is the p value for the number of events \<70 mg/dL that were greater than 2 hours||||0.010
71081423|NCT01680653|141669790|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Fisher's exact test|||This is the p value for the number of events that were \<50 mg/dL for \> 30 minutes||||0.021
71081424|NCT01680653|141669790|SUPERIORITY_OR_OTHER|||||||0.077|TWO_SIDED||||||Fisher's exact|||This is the P value for the number of events \<50 mg/dL that were \>1 hr||||0.077
71120980|NCT02649192|141747894|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG3 at day 56 in 2017-18 season||||0.54
71120981|NCT02649192|141747894|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgM at day 56 in 2015-16 season||||0.90
70944058|NCT01568112|141388078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-0.8|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||0.8|-0.8|
70944059|NCT01568112|141388078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-1.7|0.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||0.4|-1.7|
71081425|NCT02488018|141669791|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|99.0|||||ANOVA|Degree of freedom for the model (treatment) was 8.||Hypothesis Ho: Honey plant origin does not affects the glycemic index of human subjects. Ha: Honey plant origin affects the glycemic index of human subjects.||||<0.01
71081426|NCT01850394|141669792|SUPERIORITY_OR_OTHER||Mean Difference (Net)|180.0|STANDARD_DEVIATION|300.0|<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
71081427|NCT01850394|141669792|SUPERIORITY_OR_OTHER||Mean Difference (Net)|150.0|STANDARD_DEVIATION|200.0|<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
71081428|NCT01850394|141669793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|140.0|STANDARD_DEVIATION|15.0|<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
71081429|NCT01850394|141669793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.0|STANDARD_DEVIATION|4.0|<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
71081430|NCT01850394|141669794|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.25|STANDARD_ERROR_OF_MEAN|0.1|<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||||||<0.05
71081431|NCT01850394|141669795|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.1|STANDARD_ERROR_OF_MEAN|0.02|<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||||||<0.05
71081432|NCT01850394|141669796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.66|STANDARD_DEVIATION|1.0||0.05|TWO_SIDED|95.0|||||ANOVA|||||||0.05
71081433|NCT04208412|141669820|SUPERIORITY|||||||0.001|||||||Wilcoxon Test (Gehan's Generalized)|||||||0.0010
71081434|NCT04208412|141669821|SUPERIORITY|||||||0.0045|||||||Prescott's Test|||||||0.0045
71081435|NCT04208412|141669822|SUPERIORITY||||||<|0.0001|||||||Wilcoxon Test (Gehan's Generalized)|||"Gehan's Generalized Wilcoxon Test:~600 mg KVD900 vs Placebo"||||<0.0001
71081436|NCT04208412|141669823|SUPERIORITY||||||<|0.0001|||||||Wilcoxon Test (Gehan's Generalized)|||||||<0.0001
71081437|NCT04208412|141669824|SUPERIORITY||||||<|0.0001|||||||Wilcoxon Test (Gehan's Generalized)|||||||<0.0001
71081438|NCT05415462|141669830|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza A H1N1 strain at a 2-sided 0.025 level.|Geometric Mean Ratio (GMR)|1.01|||||TWO_SIDED|97.5|0.952|1.071||||||GMR (mRNA-1010 vs Fluarix) for Influenza A H1N1 Antibody||1.071|0.952|
71081439|NCT05415462|141669830|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza A H3N2 strain at a 2-sided 0.025 level.|GMR|1.657|||||TWO_SIDED|97.5|1.562|1.757||||||GMR (mRNA-1010 vs Fluarix) for Influenza A H3N2 Antibody||1.757|1.562|
71081440|NCT05415462|141669830|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza B Victoria-lineage strain at a 2-sided 0.025 level.|GMR|0.665|||||TWO_SIDED|97.5|0.63|0.702||||||GMR (mRNA-1010 vs Fluarix) for Influenza B/ Victoria Lineage||0.702|0.630|
71120982|NCT02649192|141747894|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgM at day 56 in 2016-17 season||||0.95
71120983|NCT02649192|141747894|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgM at day 56 in 2017-18 season||||0.34
71120984|NCT02649192|141747895|SUPERIORITY||Treatment Difference in Seroconversion R|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Treatment group minus placebo|H1N1||0|0|
71120985|NCT02649192|141747895|SUPERIORITY||Treatment Difference in Seroconversion R|-23.6|||||TWO_SIDED|95.0|-51.7|6.2|||||Treatment group minus placebo|H1N1||6.2|-51.7|
70855294|NCT02880956|141198382|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|3.12|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70944060|NCT01568112|141388078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.7|0.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||0.2|-1.7|
71120986|NCT02649192|141747895|SUPERIORITY||Treatment Difference in Seroconversion R|-13.0|||||TWO_SIDED|95.0|-49.4|26.5|||||Treatment group minus placebo|H1N1||26.5|-49.4|
71120987|NCT02649192|141747895|SUPERIORITY||Treatment Difference in Seroconversion R|-10.0|||||TWO_SIDED|95.0|-70.1|56.1|||||Treatment group minus placebo|H3N2||56.1|-70.1|
71120988|NCT02649192|141747895|SUPERIORITY||Treatment Difference in Seroconversion R|-8.6|||||TWO_SIDED|95.0|-38.8|20.6|||||Treatment group minus placebo|H3N2||20.6|-38.8|
71120989|NCT02649192|141747895|SUPERIORITY||Treatment Difference in Seroconversion R|22.7|||||TWO_SIDED|95.0|-17.5|57.9|||||Treatment group minus placebo|H3N2||57.9|-17.5|
71120990|NCT02649192|141747895|SUPERIORITY||Treatment Difference in Seroconversion R|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Treatment group minus placebo|B/Phuket||0|0|
71120991|NCT02649192|141747895|SUPERIORITY||Treatment Difference in Seroconversion R|-26.4|||||TWO_SIDED|95.0|-54.1|5.8|||||Treatment group minus placebo|B/Phuket||5.8|-54.1|
71120992|NCT02649192|141747895|SUPERIORITY||Treatment Difference in Seroconversion R|16.9|||||TWO_SIDED|95.0|-23.1|53.3|||||Treatment group minus placebo|B/Phuket||53.3|-23.1|
71120993|NCT02649192|141747895|SUPERIORITY||Treatment Difference in Seroconversion R|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Treatment group minus placebo|B/Brisbane||0|0|
71120994|NCT02649192|141747895|SUPERIORITY||Treatment Difference in Seroconversion R|-26.4|||||TWO_SIDED|95.0|-54.1|5.8|||||Treatment group minus placebo|B/Brisbane||5.8|-54.1|
71120995|NCT02649192|141747895|SUPERIORITY||Treatment Difference in Seroconversion R|-8.4|||||TWO_SIDED|95.0|-45.4|30.5|||||Treatment group minus placebo|B/Brisbane||30.5|-45.4|
70944061|NCT01568112|141388078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-0.7|0.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||0.6|-0.7|
71120996|NCT00438854|141747905|SUPERIORITY_OR_OTHER||Estimating proportion of responders|0.2||||||||||||||The primary measures of efficacy of tumor response were: complete remission (CR), nodular partial remission (nPR), or partial remission (PR), as per NCI-WG criteria. The true ORR is reported as percentage and 90% CI calculated using the binomial exact test. Time to treatment failure (TTF) was defined from the date on study to date of progression, death in remission, initiation of non-protocol therapy in the absence of progression, or censored on the last visit.||||
71120997|NCT00787930|141747927|SUPERIORITY_OR_OTHER||||||>|0.05||||||a priori threshold for significance was 0.05|Chi-squared|||||||>0.05
71120998|NCT00787930|141747928|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|df=1||||||1.00
71120999|NCT00787930|141747929|SUPERIORITY_OR_OTHER|||||||0.6056||||||No adjustment for multiple comparisons|Chi-squared|df=1||||||0.6056
71121000|NCT00787930|141747930|NON_INFERIORITY_OR_EQUIVALENCE|Exploratory hypothesis|t-stat estimated value|1.52|STANDARD_DEVIATION|8.2||0.081|ONE_SIDED|95.0|0.0||||t-test, 1 sided|missing values: 6 df=7|||||0|0.081
71121001|NCT00787930|141747931|NON_INFERIORITY_OR_EQUIVALENCE|Exploratory analyses|t-stat estimated value|1.47|STANDARD_DEVIATION|6.56||0.091|ONE_SIDED|95.0|0.0|||no adjustment for multiple analyses|t-test, 1 sided|missing values: 5 df=7|||||0|0.091
71121002|NCT01049802|141747951|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71121003|NCT01049802|141747952|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71121004|NCT01049802|141747953|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71121005|NCT01049802|141747954|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71121006|NCT01049802|141747955|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71121007|NCT02193087|141747962|NON_INFERIORITY_OR_EQUIVALENCE|Based on the Two One-Sided Tests (TOST) with α=0.05, if the 90% CI for the ratio of GMT for a given dengue serotype for the comparison was within the range of 0.67 and 1, then the 2 formulations were deemed equivalent.|LS Mean Ratio|0.29|||||TWO_SIDED|90.0|0.23|0.36||||||DEN-1||0.36|0.23|
71121008|NCT02193087|141747962|NON_INFERIORITY_OR_EQUIVALENCE|Based on the Two One-Sided Tests (TOST) with α=0.05, if the 90% CI for the ratio of GMT for a given dengue serotype for the comparison was within the range of 0.67 and 1, then the 2 formulations were deemed equivalent.|LS Mean Ratio|1.06|||||TWO_SIDED|90.0|0.9|1.26||||||DEN-2||1.26|0.90|
71121009|NCT02193087|141747962|NON_INFERIORITY_OR_EQUIVALENCE|Based on the Two One-Sided Tests (TOST) with α=0.05, if the 90% CI for the ratio of GMT for a given dengue serotype for the comparison was within the range of 0.67 and 1, then the 2 formulations were deemed equivalent.|LS Mean Ratio|1.46|||||TWO_SIDED|90.0|1.13|1.89||||||DEN-3||1.89|1.13|
71121010|NCT02193087|141747962|NON_INFERIORITY_OR_EQUIVALENCE|Based on the Two One-Sided Tests (TOST) with α=0.05, if the 90% CI for the ratio of GMT for a given dengue serotype for the comparison was within the range of 0.67 and 1, then the 2 formulations were deemed equivalent.|LS Mean Ratio|0.74|||||TWO_SIDED|90.0|0.57|0.95||||||DEN-4||0.95|0.57|
71121011|NCT04030247|141747975|OTHER|||||||0.03|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.03
71121012|NCT04030247|141747976|OTHER|||||||0.16|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.16
71121013|NCT04030247|141747977|OTHER|||||||0.03|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.03
71121014|NCT04030247|141747978|OTHER|||||||0.9|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.9
71121015|NCT04030247|141747979|OTHER|||||||0.5|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.5
71121016|NCT04030247|141747980|OTHER|||||||0.4|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.4
71121017|NCT04030247|141747982|OTHER|||||||0.6|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.6
71121018|NCT01340937|141748055|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the Geometric Mean Concentration (GMC) ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.91|||||TWO_SIDED|95.0|0.77|1.08|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.08|0.77|
70944062|NCT01568112|141388078|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|95.0|-0.7|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||0.8|-0.7|
71081441|NCT05415462|141669830|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza B Yamagata-lineage strain at a 2-sided 0.025 level.|GMR|0.661|||||TWO_SIDED|97.5|0.63|0.693||||||GMR (mRNA-1010 vs Fluarix) for Influenza B/ Yamagata Lineage||0.693|0.630|
71121019|NCT01340937|141748055|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.86|||||TWO_SIDED|95.0|0.72|1.02|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.02|0.72|
71121020|NCT01340937|141748055|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|0.94|||||TWO_SIDED|95.0|0.79|1.12|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.12|0.79|
71121021|NCT01340937|141748055|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.63|||<|0.001|TWO_SIDED|95.0|1.35|1.98|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.98|1.35|<0.001
71121022|NCT01340937|141748056|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|-0.48|||||TWO_SIDED|95.0|-4.31|3.35|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|Equivalence for titer \>=1 µg/mL||3.35|-4.31|
71121023|NCT01340937|141748056|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|-1.62|||||TWO_SIDED|95.0|-5.38|2.12|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|Equivalence for titer \>=1 µg/mL||2.12|-5.38|
71121024|NCT01340937|141748056|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-1.16|||||TWO_SIDED|95.0|-4.89|2.58|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|Equivalence for titer \>=1 µg/mL||2.58|-4.89|
71121025|NCT01340937|141748056|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|7.93|||<|0.001|TWO_SIDED|95.0|3.38|13.17|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||Non-inferiority for titer \>=1 µg/mL||13.17|3.38|<0.001
71121026|NCT01340937|141748056|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (Comb - Ctrl)|2.2|||<|0.001|TWO_SIDED|95.0|0.39|5.12|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||Non-inferiority for titer \>=0.15 µg/mL||5.12|0.39|<0.001
71121027|NCT01340937|141748057|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.87|||||TWO_SIDED|95.0|0.76|0.98|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.98|0.76|
71121028|NCT01340937|141748057|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.85|||||TWO_SIDED|95.0|0.74|0.96|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.96|0.74|
71121029|NCT01340937|141748057|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|0.98|||||TWO_SIDED|95.0|0.86|1.11|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.11|0.86|
71121030|NCT01340937|141748058|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.95|||||TWO_SIDED|95.0|0.84|1.07|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.07|0.84|
71121031|NCT01340937|141748058|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.97|||||TWO_SIDED|95.0|0.86|1.09|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.09|0.86|
71121032|NCT01340937|141748058|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|1.02|||||TWO_SIDED|95.0|0.9|1.14|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.14|0.90|
71121033|NCT01340937|141748059|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.97|||||TWO_SIDED|95.0|0.91|1.04|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.04|0.91|
70944063|NCT01568112|141388078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|95.0|-0.6|0.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||0.7|-0.6|
71081442|NCT05415462|141669831|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza A H1N1 strain at a 2-sided 0.025 level.|Percentage Difference|5.75|||||TWO_SIDED|97.5|3.12|8.38||||||Percentage Difference (mRNA-1010 vs Fluarix) for Influenza A H1N1 Antibody||8.38|3.12|
71081443|NCT05415462|141669831|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza A H3N2 strain at a 2-sided 0.025 level.|Percentage Difference|16.91|||||TWO_SIDED|97.5|14.27|19.54||||||Percentage Difference (mRNA-1010 vs Fluarix) for Influenza A H3N2 Antibody||19.54|14.27|
71081444|NCT05415462|141669831|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza B Victoria-lineage strain at a 2-sided 0.025 level.|Percentage Difference|-17.34|||||TWO_SIDED|97.5|-20.22|-14.43||||||Percentage Difference (mRNA-1010 vs Fluarix) for Influenza B/Victoria Lineage||-14.43|-20.22|
71081445|NCT05415462|141669831|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza B Yamagata-lineage strain at a 2-sided 0.025 level.|Percentage Difference|-15.68|||||TWO_SIDED|97.5|-18.57|-12.76||||||Percentage Difference (mRNA-1010 vs Fluarix) for Influenza B/Yamagata Lineage||-12.76|-18.57|
71081446|NCT01129804|141669852|SUPERIORITY|Longitudinal Linear mixed modeling|Slope|0.1|||<|0.04|TWO_SIDED|||||Tested the null hypothesis that slopes of PDA over time would not differ between treatment conditions, as indicated by the significance of the Treatment main effect and Treatment X Time interaction effect, at the level of p \< .05.|Mixed Models Analysis||||Multilevel longitudinal modeling (MLM) with random effects and maximum likelihood estimation (Proc MIXED; SAS Institute, 1999) was used to evaluate the effects of treatment over time for each of the continuously scaled outcome variables described above. The MLM approach was used because it employs maximum likelihood estimation of covariance matrices rather than raw data, allowing us to take advantage of all data collected for anyone randomized to treatment. Each repeated dependent variable was analyzed as a unction of treatment condition, time since intake (in months), and the interaction of treatment condition by time.|||<.04
71081447|NCT02259699|141669866|SUPERIORITY|||||||0.582|||||||t-test, 2 sided|||Difference between arms at T1||||0.582
71081448|NCT02259699|141669866|SUPERIORITY|||||||0.053|||||||t-test, 2 sided|||Difference between arms at T3||||0.053
71081449|NCT02259699|141669866|SUPERIORITY|||||||0.288|||||||t-test, 2 sided|||Difference between arms at T4||||0.288
71081450|NCT02259699|141669867|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|||Difference between arms at T3||||0.087
70855295|NCT02880956|141198382|SUPERIORITY||LS Mean of Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.402||0.265|TWO_SIDED|95.0|-1.239|0.342||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.342|-1.239|0.265
70855296|NCT02880956|141198382|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|3.15|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71121034|NCT01340937|141748059|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|1.02|||||TWO_SIDED|95.0|0.95|1.09|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.09|0.95|
71081451|NCT02259699|141669867|SUPERIORITY|||||||0.91|||||||t-test, 2 sided|||Difference between arms at T4||||0.910
71081452|NCT02259699|141669868|SUPERIORITY|||||||0.807|||||||t-test, 2 sided|||||||0.807
71081453|NCT02259699|141669869|SUPERIORITY|||||||0.071|||||||t-test, 2 sided|||Difference between arms at T3||||0.071
71081454|NCT02259699|141669869|SUPERIORITY|||||||0.332|||||||t-test, 2 sided|||Difference between arms at T4||||0.332
71081455|NCT02259699|141669870|SUPERIORITY|||||||0.177|||||||t-test, 2 sided|||Difference between arms at T3||||0.177
71081456|NCT02259699|141669870|SUPERIORITY|||||||0.745|||||||t-test, 2 sided|||Difference between arms at T4||||0.745
71081457|NCT03828214|141669903|SUPERIORITY||Mean Difference (Final Values)|2.4|STANDARD_DEVIATION|9.2||0.973|TWO_SIDED|||||a priori threshold for statistical significance was 0.05.|ANOVA|||C2, C3, C4 were compared to C1 the comparison condition.||||0.973
71081458|NCT00305565|141669907|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.34||||0.803|TWO_SIDED|95.0|-2.34|3.02|||Mixed Models Analysis|||The primary analysis consisted of contrasts comparing High Dose vs. Low Dose and Medium Dose vs. Low Dose averaged over the 4 Acute Phase visits using the Hochberg approach to adjust for multiplicity. If both comparisons involving the Low Dose were significant, then a test of High Dose vs. Medium Dose was evaluated at the P≤0.05 level. The pivotal analysis was performed on the ITT population using the last-observation-carried-forward (LOCF) approach to impute missing data.||3.02|-2.34|0.803
71081459|NCT00305565|141669907|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33||||0.813|TWO_SIDED|95.0|-2.39|3.05|||Mixed Models Analysis|||The primary analysis consisted of contrasts comparing High Dose vs. Low Dose and Medium Dose vs. Low Dose averaged over the 4 Acute Phase visits using the Hochberg approach to adjust for multiplicity. If both comparisons involving the Low Dose were significant, then a test of High Dose vs. Medium Dose was evaluated at the P≤0.05 level. The pivotal analysis was performed on the ITT population using the last-observation-carried-forward (LOCF) approach to impute missing data.||3.05|-2.39|0.813
71081460|NCT00502853|141669987|SUPERIORITY_OR_OTHER|||||||0.1776|||||||Student's t-test|||Change from Baseline to Week 4||||0.1776
71081461|NCT00502853|141669987|SUPERIORITY_OR_OTHER|||||||0.1215|||||||Student's t-test|||Change from Baseline to Week 24||||0.1215
71081462|NCT00502853|141669987|SUPERIORITY_OR_OTHER||Slope|-0.1606|STANDARD_ERROR_OF_MEAN|0.1231||0.2246|||||||Random coefficient model|||Trend over time||||0.2246
71081463|NCT00502853|141669988|SUPERIORITY_OR_OTHER|||||||0.8989|||||||Student's t-test|||Change from Baseline to Week 4||||0.8989
71081464|NCT00502853|141669988|SUPERIORITY_OR_OTHER|||||||0.8834|||||||Student's t-test|||Change from Baseline to Week 24||||0.8834
71081465|NCT00502853|141669988|SUPERIORITY_OR_OTHER||Slope|0.1357|STANDARD_ERROR_OF_MEAN|0.9051||0.8841|||||||Random coefficient model|||Trend over time||||0.8841
71081466|NCT00502853|141669989|SUPERIORITY_OR_OTHER|||||||0.5911|||||||Student's t-test|||Change from Baseline to Week 4||||0.5911
71081467|NCT00502853|141669989|SUPERIORITY_OR_OTHER|||||||0.1475|||||||Student's t-test|||Change from Baseline to Week 24||||0.1475
71081468|NCT00502853|141669989|SUPERIORITY_OR_OTHER||Slope|0.1786|STANDARD_ERROR_OF_MEAN|0.1123||0.1463|||||||Random coefficient model|||Trend over time||||0.1463
71081469|NCT00502853|141669990|SUPERIORITY_OR_OTHER|||||||0.1101|||||||Student's t-test|||Change from Baseline at Week 4||||0.1101
71081470|NCT00502853|141669990|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Student's t-test|||Change from Baseline at Week 12||||0.0003
71121035|NCT01340937|141748059|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|1.05|||||TWO_SIDED|95.0|0.98|1.13|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.13|0.98|
71121036|NCT01340937|141748060|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|1.03|||||TWO_SIDED|95.0|0.96|1.1|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.10|0.96|
71121037|NCT01340937|141748060|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|1.02|||||TWO_SIDED|95.0|0.95|1.09|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.09|0.95|
71121038|NCT01340937|141748060|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|0.99|||||TWO_SIDED|95.0|0.92|1.06|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.06|0.92|
71121039|NCT01340937|141748060|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.2|||<|0.001|TWO_SIDED|95.0|1.11|1.29|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Secondary analysis||1.29|1.11|<0.001
71121040|NCT01340937|141748061|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.89|||||TWO_SIDED|95.0|0.83|0.96|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.96|0.83|
71121041|NCT01340937|141748061|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.78|||||TWO_SIDED|95.0|0.72|0.83|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.83|0.72|
71121042|NCT01340937|141748061|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|0.87|||||TWO_SIDED|95.0|0.81|0.94|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.94|0.81|
71121043|NCT01340937|141748061|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.67||||0.419|TWO_SIDED|95.0|0.62|0.73|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Secondary analysis||0.73|0.62|0.419
71121044|NCT01340937|141748062|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.97|||||TWO_SIDED|95.0|0.87|1.09|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.09|0.87|
71121045|NCT01340937|141748062|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.93|||||TWO_SIDED|95.0|0.83|1.05|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.05|0.83|
71121046|NCT01340937|141748062|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|0.96|||||TWO_SIDED|95.0|0.85|1.08|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.08|0.85|
71121047|NCT01340937|141748062|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.03|||<|0.001|TWO_SIDED|95.0|0.9|1.17|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Secondary analysis||1.17|0.90|<0.001
71121048|NCT01340937|141748063|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.78|||||TWO_SIDED|95.0|0.72|0.85|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.85|0.72|
70944064|NCT01568112|141388078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-0.2|1.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||1.3|-0.2|
70944065|NCT01568112|141388078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|-0.4|0.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||0.4|-0.4|
71121049|NCT01340937|141748063|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.8|||||TWO_SIDED|95.0|0.73|0.87|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.87|0.73|
71121050|NCT01340937|141748063|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|1.02|||||TWO_SIDED|95.0|0.93|1.11|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.11|0.93|
71121051|NCT01340937|141748063|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.51|||<|0.001|TWO_SIDED|95.0|1.37|1.66|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Secondary analysis||1.66|1.37|<0.001
71121052|NCT01340937|141748064|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the Geometric Mean Titer (GMT) ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot B)|0.86|||||TWO_SIDED|95.0|0.76|0.96|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.96|0.76|
71121053|NCT01340937|141748064|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot C)|0.88|||||TWO_SIDED|95.0|0.79|0.99|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.99|0.79|
71121054|NCT01340937|141748064|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot B/Lot C)|1.03|||||TWO_SIDED|95.0|0.92|1.15|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.15|0.92|
71081471|NCT00502853|141669990|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Student's t-test|||Change from Baseline at Week 24||||0.0018
71081472|NCT00502853|141669990|SUPERIORITY_OR_OTHER||Slope|-2.0857|STANDARD_ERROR_OF_MEAN|0.4965||0.0023|||||||Random coefficient model|||Trend over time||||0.0023
70944066|NCT01568112|141388078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.4|0.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||0.2|-0.4|
70944067|NCT01568112|141388078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-0.6|0.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||0.6|-0.6|
71081473|NCT00502853|141669991|SUPERIORITY_OR_OTHER|||||||0.3358|||||||Student's t-test|||Change from Baseline at Week 4||||0.3358
71081474|NCT00502853|141669991|SUPERIORITY_OR_OTHER|||||||0.9158|||||||Student's t-test|||Change from Baseline at Week 24||||0.9158
71081475|NCT00502853|141669991|SUPERIORITY_OR_OTHER||Slope|0.003418|STANDARD_ERROR_OF_MEAN|0.02345||0.8877|||||||Random coefficient model|||Trend over time||||0.8877
71081476|NCT00502853|141669992|SUPERIORITY_OR_OTHER|||||||0.7624|||||||Student's t-test|||Change from Baseline at Week 4||||0.7624
71081477|NCT00502853|141669992|SUPERIORITY_OR_OTHER|||||||0.0212|||||||Student's t-test|||Change from Baseline at Week 24||||0.0212
71081478|NCT00502853|141669992|SUPERIORITY_OR_OTHER||Slope|-4.2681|STANDARD_ERROR_OF_MEAN|2.0529||0.0712|||||||Random coefficient model|||Trend over time||||0.0712
71081479|NCT00502853|141669993|SUPERIORITY_OR_OTHER|||||||0.024|||||||Student's t-test|||Change from Baseline at Week 4||||0.0240
71081480|NCT00502853|141669993|SUPERIORITY_OR_OTHER|||||||0.0045|||||||Student's t-test|||Change from Baseline at Week 12||||0.0045
71081481|NCT00502853|141669993|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Student's t-test|||Change from Baseline at Week 24||||0.0018
71081482|NCT00502853|141669993|SUPERIORITY_OR_OTHER||Slope|-0.1964|STANDARD_ERROR_OF_MEAN|0.04524||0.0019|||||||Random Coefficient Model|||Trend over time||||0.0019
71081483|NCT00502853|141669994|SUPERIORITY_OR_OTHER||Slope|-6.6294|STANDARD_ERROR_OF_MEAN|1.8623||0.0074|||||||Random Coefficient Model|||Trend over time||||0.0074
71081484|NCT00502853|141669994|SUPERIORITY_OR_OTHER|||||||0.1273|||||||Student's t-test|||Change from Baseline at Week 4||||0.1273
71081485|NCT00502853|141669994|SUPERIORITY_OR_OTHER|||||||0.0132|||||||Student's t-test|||Change from Baseline at Week 12||||0.0132
71081486|NCT00502853|141669994|SUPERIORITY_OR_OTHER|||||||0.1542|||||||Student's t-test|||Change from Baseline at Week 24||||0.1542
71081487|NCT00502853|141669995|SUPERIORITY_OR_OTHER|||||||0.1396|||||||Student's t-test|||Change from Baseline at Week 4||||0.1396
71081488|NCT00502853|141669995|SUPERIORITY_OR_OTHER|||||||0.005|||||||Student's t-test|||Change from Baseline at Week 12||||0.0050
71081489|NCT00502853|141669995|SUPERIORITY_OR_OTHER|||||||0.005|||||||Student's t-test|||Change from Baseline at Week 24||||0.0050
70944068|NCT01568112|141388078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|95.0|-0.7|0.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||0.5|-0.7|
70944069|NCT01568112|141388078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|95.0|-0.1|1.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||1.0|-0.1|
70944070|NCT01568112|141388078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.2|0.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||0.6|-0.2|
70944071|NCT01568112|141388078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|95.0|-0.8|0.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||0.7|-0.8|
70944072|NCT01568112|141388078|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-0.7|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||0.8|-0.7|
70944073|NCT01568112|141388078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-1.6|0.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||-0.0|-1.6|
70944074|NCT01568112|141388078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-1.2|0.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||0.5|-1.2|
70944075|NCT01568112|141388079|SUPERIORITY_OR_OTHER||Difference in percentage|9.0|||||TWO_SIDED|95.0|-11.8|30.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||30.0|-11.8|
70944076|NCT01568112|141388079|SUPERIORITY_OR_OTHER||Difference in percentage|9.0|||||TWO_SIDED|95.0|-11.8|30.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||30.0|-11.8|
70944077|NCT01568112|141388080|SUPERIORITY_OR_OTHER||Difference in percentage|2.0|||||TWO_SIDED|95.0|-18.8|23.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||23.3|-18.8|
70944078|NCT01568112|141388080|SUPERIORITY_OR_OTHER||Difference in percentage|6.0|||||TWO_SIDED|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||27.8|-14.1|
70944079|NCT01568112|141388081|SUPERIORITY_OR_OTHER||Difference in percentage|-9.0|||||TWO_SIDED|95.0|-32.1|14.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||14.3|-32.1|
71081490|NCT00502853|141669995|SUPERIORITY_OR_OTHER||Slope|-0.2902|STANDARD_ERROR_OF_MEAN|0.07966||0.0054|||||||Random coefficient model|||Trend over time||||0.0054
71081491|NCT00502853|141669996|SUPERIORITY_OR_OTHER|||||||0.0254|||||||Student's t-test|||Change from Baseline at Week 4||||0.0254
71081492|NCT00502853|141669996|SUPERIORITY_OR_OTHER|||||||0.0384|||||||Student's t-test|||Change from Baseline at Week 12||||0.0384
71081493|NCT00502853|141669996|SUPERIORITY_OR_OTHER|||||||0.0271|||||||Student's t-test|||Change from Baseline at Week 24||||0.0271
71081494|NCT00502853|141669996|SUPERIORITY_OR_OTHER||Slope|-4.7586|STANDARD_ERROR_OF_MEAN|1.5278||0.0124|||||||Random coefficient model|||Trend over time||||0.0124
71081495|NCT00502853|141669997|SUPERIORITY_OR_OTHER|||||||0.7376|||||||Student's t-test|||Change from Baseline at Week 4||||0.7376
70944080|NCT01568112|141388081|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0|||||TWO_SIDED|95.0|-25.0|21.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||21.7|-25.0|
70944081|NCT01568112|141388088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|13.79|||TWO_SIDED|95.0|-20.9|34.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||34.1|-20.9|
70944082|NCT01568112|141388088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|STANDARD_ERROR_OF_MEAN|10.03|||TWO_SIDED|95.0|-14.2|25.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||25.7|-14.2|
70944083|NCT01568112|141388089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.2|STANDARD_ERROR_OF_MEAN|24.4|||TWO_SIDED|95.0|-26.5|70.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||70.9|-26.5|
71081496|NCT00502853|141669997|SUPERIORITY_OR_OTHER|||||||0.1631|||||||Student's t-test|||Change from Baseline at Week 12||||0.1631
71081497|NCT00502853|141669997|SUPERIORITY_OR_OTHER|||||||0.8816|||||||Student's t-test|||Change from Baseline at Week 24||||0.8816
71081498|NCT00502853|141669997|SUPERIORITY_OR_OTHER||Slope|-0.2927|STANDARD_ERROR_OF_MEAN|1.9408||0.8835|||||||Random coefficient model|||Trend over time||||0.8835
71081499|NCT00502853|141669998|SUPERIORITY_OR_OTHER|||||||0.1312|||||||Student's t-test|||Change from Baseline at Week 4||||0.1312
71081500|NCT00502853|141669998|SUPERIORITY_OR_OTHER|||||||0.0662|||||||Student's t-test|||Change from Baseline at Week 12||||0.0662
71081501|NCT00502853|141669998|SUPERIORITY_OR_OTHER|||||||0.4133|||||||Student's t-test|||Change from Baseline at Week 24||||0.4133
71081502|NCT00502853|141669998|SUPERIORITY_OR_OTHER||Slope|8.8196|STANDARD_ERROR_OF_MEAN|16.4534||0.6049|||||||Random coefficient model|||Trend over time||||0.6049
71081503|NCT00502853|141669999|SUPERIORITY_OR_OTHER|||||||0.1725|||||||Student's t-test|||Change from Baseline at Week 4||||0.1725
71081504|NCT00502853|141669999|SUPERIORITY_OR_OTHER|||||||0.0832|||||||Student's t-test|||Change from Baseline at Week 12||||0.0832
71081505|NCT00502853|141669999|SUPERIORITY_OR_OTHER|||||||0.1685|||||||Student's t-test|||Change from Baseline at Week 24||||0.1685
71081506|NCT00502853|141669999|SUPERIORITY_OR_OTHER||Slope|-55.4458|STANDARD_ERROR_OF_MEAN|33.5821||0.1331|||||||Random coefficient model|||Trend over time||||0.1331
71081507|NCT00502853|141670000|SUPERIORITY_OR_OTHER|||||||0.2938|||||||Student's t-test|||Change from Baseline at Week 4||||0.2938
71081508|NCT00502853|141670000|SUPERIORITY_OR_OTHER|||||||0.2216|||||||Student's t-test|||Change from Baseline at Week 12||||0.2216
71081509|NCT00502853|141670000|SUPERIORITY_OR_OTHER|||||||0.567|TWO_SIDED||||||Student's t-test|||Change from Baseline at Week 24||||0.5670
71081510|NCT00502853|141670001|SUPERIORITY_OR_OTHER|||||||0.0934|||||||Student's t-test|||Change from Baseline at Week 4||||0.0934
71081511|NCT00502853|141670001|SUPERIORITY_OR_OTHER|||||||0.4047|||||||Student's t-test|||Change from Baseline at Week 12||||0.4047
71081512|NCT00502853|141670001|SUPERIORITY_OR_OTHER|||||||0.2101|||||||Student's t-test|||Change from Baseline at Week 24||||0.2101
71081513|NCT00502853|141670001|SUPERIORITY_OR_OTHER||Slope|0.3997|STANDARD_ERROR_OF_MEAN|0.2506||0.1451|||||||Random coefficient model|||Trend over time||||0.1451
71081514|NCT00502853|141670002|SUPERIORITY_OR_OTHER|||||||0.4963|||||||Student's t-test|||Change from Baseline at Week 4||||0.4963
71081515|NCT00502853|141670002|SUPERIORITY_OR_OTHER|||||||0.2198|||||||Student's t-test|||Change from Baseline at Week 12||||0.2198
71081516|NCT00502853|141670002|SUPERIORITY_OR_OTHER|||||||0.6773|||||||Student's t-test|||Change from Baseline at Week 24||||0.6773
71081517|NCT00502853|141670002|SUPERIORITY_OR_OTHER||Slope|0.3688|STANDARD_ERROR_OF_MEAN|0.5987||0.5531|||||||Random coefficient model|||Trend over time||||0.5531
71081518|NCT00502853|141670003|SUPERIORITY_OR_OTHER|||||||0.5002|||||||Student's t-test|||Change from Baseline at Week 24||||0.5002
71081519|NCT00502853|141670004|SUPERIORITY_OR_OTHER|||||||1|||||||Student's t-test|||Change from Baseline at Week 24||||1.0000
71081520|NCT00502853|141670005|SUPERIORITY_OR_OTHER|||||||0.7002|||||||Student's t-test|||Change from Baseline at Week 24||||0.7002
71081521|NCT00502853|141670006|SUPERIORITY_OR_OTHER|||||||0.3132|||||||Student's t-test|||Change from Baseline at Week 24||||0.3132
71081522|NCT00502853|141670007|SUPERIORITY_OR_OTHER|||||||0.8597|||||||Student's t-test|||Change from Baseline at Week 24||||0.8597
71081523|NCT00502853|141670008|SUPERIORITY_OR_OTHER|||||||0.3617|||||||Student's t-test|||Change from Baseline at Week 24||||0.3617
71081524|NCT03373461|141670148|OTHER|||||||0.038|||||||Multiple Comparison Procedure-Modeling|||||||0.038
71081525|NCT03373461|141670148|OTHER||Ratio to placebo (of ratio to baseline)|0.99|||||TWO_SIDED|80.0|0.86|1.0||||||||1.00|0.86|
71081526|NCT03373461|141670148|OTHER||Ratio to placebo (of ratio to baseline)|0.94|||||TWO_SIDED|80.0|0.76|0.98||||||||0.98|0.76|
71081527|NCT03373461|141670148|OTHER||Ratio to placebo (of ratio to baseline)|0.87|||||TWO_SIDED|80.0|0.72|0.96||||||||0.96|0.72|
71081528|NCT03373461|141670148|OTHER||Ratio to placebo (of ratio to baseline)|0.77|||||TWO_SIDED|80.0|0.66|0.92||||||||0.92|0.66|
71081529|NCT03373461|141670149|OTHER||Mean Difference (Final Values)|3.28|||||TWO_SIDED|80.0|0.21|6.344||||||||6.344|0.210|
71081530|NCT03373461|141670149|OTHER||Mean Difference (Final Values)|5.83|||||TWO_SIDED|80.0|2.642|9.01||||||||9.010|2.642|
71081531|NCT03373461|141670149|OTHER||Mean Difference (Final Values)|3.56|||||TWO_SIDED|80.0|0.427|6.7||||||||6.700|0.427|
71081532|NCT03373461|141670149|OTHER||Mean Difference (Final Values)|5.76|||||TWO_SIDED|80.0|2.882|8.638||||||||8.638|2.882|
71081533|NCT03373461|141670150|OTHER||Mean Difference (Final Values)|-9.2|||||TWO_SIDED|80.0|-15.253|-3.145||||||||-3.145|-15.253|
71081534|NCT03373461|141670150|OTHER||Mean Difference (Final Values)|-9.25|||||TWO_SIDED|80.0|-15.499|-3.0||||||||-3.000|-15.499|
71081535|NCT03373461|141670150|OTHER||Mean Difference (Final Values)|-5.89|||||TWO_SIDED|80.0|-12.04|0.26||||||||0.260|-12.040|
71081536|NCT03373461|141670150|OTHER||Mean Difference (Final Values)|-10.12|||||TWO_SIDED|80.0|-15.763|-4.471||||||||-4.471|-15.763|
71081537|NCT03373461|141670152|OTHER||Ratio to placebo (of ratio to baseline)|0.95|||||TWO_SIDED|80.0|0.742|1.222||||||||1.222|0.742|
71081538|NCT03373461|141670152|OTHER||Ratio to placebo (of ratio to baseline)|1.06|||||TWO_SIDED|80.0|0.83|1.356||||||||1.356|0.830|
71081539|NCT03373461|141670152|OTHER||Ratio to placebo (of ratio to baseline)|0.73|||||TWO_SIDED|80.0|0.569|0.928||||||||0.928|0.569|
71081540|NCT03373461|141670152|OTHER||Ratio to placebo (of ratio to baseline)|0.84|||||TWO_SIDED|80.0|0.669|1.05||||||||1.050|0.669|
71081541|NCT03373461|141670153|OTHER||Ratio to placebo (of ratio to baseline)|0.96|||||TWO_SIDED|80.0|0.741|1.25||||||||1.250|0.741|
71081542|NCT03373461|141670153|OTHER||Ratio to placebo (of ratio to baseline)|1.13|||||TWO_SIDED|80.0|0.872|1.458||||||||1.458|0.872|
71081543|NCT03373461|141670153|OTHER||Ratio to placebo (of ratio to baseline)|0.74|||||TWO_SIDED|80.0|0.574|0.957||||||||0.957|0.574|
71081544|NCT03373461|141670153|OTHER||Ratio to placebo (of ratio to baseline)|0.89|||||TWO_SIDED|80.0|0.706|1.132||||||||1.132|0.706|
71081545|NCT03373461|141670154|OTHER||Ratio to placebo (of ratio to baseline)|0.98|||||TWO_SIDED|80.0|0.794|1.214||||||||1.214|0.794|
71081546|NCT03373461|141670154|OTHER||Ratio to placebo (of ratio to baseline)|1.03|||||TWO_SIDED|80.0|0.835|1.269||||||||1.269|0.835|
71081547|NCT03373461|141670154|OTHER||Ratio to placebo (of ratio to baseline)|0.76|||||TWO_SIDED|80.0|0.616|0.942||||||||0.942|0.616|
71081548|NCT03373461|141670154|OTHER||Ratio to placebo (of ratio to baseline)|0.85|||||TWO_SIDED|80.0|0.704|1.027||||||||1.027|0.704|
71081549|NCT03373461|141670155|OTHER||Ratio to placebo (of ratio to baseline)|0.92|||||TWO_SIDED|80.0|0.723|1.172||||||||1.172|0.723|
71081550|NCT03373461|141670155|OTHER||Ratio to placebo (of ratio to baseline)|0.98|||||TWO_SIDED|80.0|0.767|1.249||||||||1.249|0.767|
71081551|NCT03373461|141670155|OTHER||Ratio to placebo (of ratio to baseline)|0.74|||||TWO_SIDED|80.0|0.577|0.937||||||||0.937|0.577|
71081552|NCT03373461|141670155|OTHER||Ratio to placebo (of ratio to baseline)|0.84|||||TWO_SIDED|80.0|0.678|1.052||||||||1.052|0.678|
71081553|NCT03373461|141670164|OTHER||Mean Difference (Final Values)|3.95|||||TWO_SIDED|80.0|0.42|7.472||||||||7.472|0.420|
70944084|NCT01568112|141388089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|11.08|||TWO_SIDED|95.0|-20.5|23.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||23.6|-20.5|
71081554|NCT03373461|141670164|OTHER||Mean Difference (Final Values)|0.82|||||TWO_SIDED|80.0|-2.747|4.39||||||||4.390|-2.747|
70855297|NCT02880956|141198382|SUPERIORITY||LS Mean of Difference|0.11|STANDARD_ERROR_OF_MEAN|0.414||0.789|TWO_SIDED|95.0|-0.704|0.925||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.925|-0.704|0.789
70944085|NCT01568112|141388090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.5|STANDARD_ERROR_OF_MEAN|13.32|||TWO_SIDED|95.0|-9.2|44.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||44.2|-9.2|
70944086|NCT01568112|141388090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|8.8|||TWO_SIDED|95.0|-17.2|18.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||18.0|-17.2|
71081555|NCT03373461|141670164|OTHER||Mean Difference (Final Values)|0.26|||||TWO_SIDED|80.0|-2.745|3.262||||||||3.262|-2.745|
71081556|NCT03373461|141670164|OTHER||Mean Difference (Final Values)|1.98|||||TWO_SIDED|80.0|-1.368|5.337||||||||5.337|-1.368|
71081557|NCT03373461|141670165|OTHER||Ratio to placebo (of ratio to baseline)|1.04|||||TWO_SIDED|80.0|0.68|1.579||||||||1.579|0.680|
71081558|NCT03373461|141670165|OTHER||Ratio to placebo (of ratio to baseline)|0.92|||||TWO_SIDED|80.0|0.607|1.39||||||||1.390|0.607|
71081559|NCT03373461|141670165|OTHER||Ratio to placebo (of ratio to baseline)|0.8|||||TWO_SIDED|80.0|0.558|1.153||||||||1.153|0.558|
71081560|NCT03373461|141670165|OTHER||Ratio to placebo (of ratio to baseline)|0.91|||||TWO_SIDED|80.0|0.614|1.362||||||||1.362|0.614|
70855298|NCT02880956|141198382|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|2.82|||TWO_SIDED|||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.||||
71081561|NCT03373461|141670167|OTHER||Geometric mean ratio|1.16|||||TWO_SIDED|80.0|0.792|1.692||||||||1.692|0.792|
71081562|NCT03373461|141670167|OTHER||Geometric mean ratio|0.65|||||TWO_SIDED|80.0|0.446|0.945||||||||0.945|0.446|
71081563|NCT03373461|141670167|OTHER||Geometric mean ratio|0.72|||||TWO_SIDED|80.0|0.518|0.997||||||||0.997|0.518|
71121055|NCT01340937|141748065|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot B)|0.94|||||TWO_SIDED|95.0|0.84|1.05|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.05|0.84|
71121056|NCT01340937|141748065|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot C)|0.91|||||TWO_SIDED|95.0|0.82|1.02|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.02|0.82|
71121057|NCT01340937|141748065|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot B/Lot C)|0.98|||||TWO_SIDED|95.0|0.87|1.09|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.09|0.87|
70855299|NCT02880956|141198383|SUPERIORITY||LS Mean of Difference|0.21|STANDARD_ERROR_OF_MEAN|0.6||0.72|TWO_SIDED|95.0|-0.965|1.395||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||1.395|-0.965|0.720
70855300|NCT02880956|141198383|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|4.73|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855301|NCT02880956|141198383|SUPERIORITY||LS Mean of Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.592||0.455|TWO_SIDED|95.0|-1.607|0.722||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.722|-1.607|0.455
70855302|NCT02880956|141198383|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|4.55|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855303|NCT02880956|141198383|SUPERIORITY||LS Mean of Difference|0.43|STANDARD_ERROR_OF_MEAN|0.605||0.473|TWO_SIDED|95.0|-0.755|1.625||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||1.625|-0.755|0.473
70855304|NCT02880956|141198383|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|4.25|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855305|NCT02880956|141198383|SUPERIORITY||LS Mean of Difference|0.16|STANDARD_ERROR_OF_MEAN|0.686||0.813|TWO_SIDED|95.0|-1.187|1.512||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.512|-1.187|0.813
71121058|NCT01340937|141748066|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot B)|1.06|||||TWO_SIDED|95.0|0.92|1.22|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.22|0.92|
71121059|NCT01340937|141748066|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot C)|1.09|||||TWO_SIDED|95.0|0.95|1.26|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.26|0.95|
71081564|NCT03373461|141670167|OTHER||Geometric mean ratio|0.8|||||TWO_SIDED|80.0|0.558|1.146||||||||1.146|0.558|
70855306|NCT02880956|141198383|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|5.3|||TWO_SIDED|||||||||Week 48||||
70855307|NCT02880956|141198383|SUPERIORITY||LS Mean of Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.672||0.421|TWO_SIDED|95.0|-1.863|0.78||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.780|-1.863|0.421
70855308|NCT02880956|141198383|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|5.51|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71081565|NCT03373461|141670168|OTHER||Ratio to placebo (of ratio to baseline)|1.14|||||TWO_SIDED|80.0|0.765|1.699||||||||1.699|0.765|
71081566|NCT03373461|141670168|OTHER||Ratio to placebo (of ratio to baseline)|0.66|||||TWO_SIDED|80.0|0.446|0.984||||||||0.984|0.446|
71081567|NCT03373461|141670168|OTHER||Ratio to placebo (of ratio to baseline)|0.71|||||TWO_SIDED|80.0|0.501|0.995||||||||0.995|0.501|
71081568|NCT03373461|141670168|OTHER||Ratio to placebo (of ratio to baseline)|0.76|||||TWO_SIDED|80.0|0.52|1.107||||||||1.107|0.520|
71081569|NCT00461097|141670174|SUPERIORITY_OR_OTHER||Risk Difference (RD)|27.5||||0.025|TWO_SIDED|95.0|4.3|43.9||No adjustments were made to the p-value.|Barnard's statistic|The a priori threshold for statistical significance is 0.05.||Number of participants who successfully consumed 10,000 mg of egg white solid was compared using Barnard's statistic with the null hypothesis that there was no difference between treatment groups.||43.9|4.3|0.025
71121060|NCT01340937|141748066|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot B/Lot C)|1.03|||||TWO_SIDED|95.0|0.9|1.19|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.19|0.90|
71121061|NCT01340937|141748067|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|-0.34|||||TWO_SIDED|95.0|-1.23|0.3|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.30|-1.23|
70944087|NCT01568112|141388091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.96|STANDARD_ERROR_OF_MEAN|4.601|||TWO_SIDED|95.0|-6.34|12.26|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||12.26|-6.34|
70944088|NCT01568112|141388091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.07|STANDARD_ERROR_OF_MEAN|2.347|||TWO_SIDED|95.0|-8.81|0.67|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||0.67|-8.81|
70944089|NCT01568112|141388091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.74|STANDARD_ERROR_OF_MEAN|7.335|||TWO_SIDED|95.0|-3.15|26.63|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||26.63|-3.15|
70944090|NCT01568112|141388091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.05|STANDARD_ERROR_OF_MEAN|2.321|||TWO_SIDED|95.0|-2.67|6.77|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||6.77|-2.67|
70944091|NCT01568112|141388091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.21|STANDARD_ERROR_OF_MEAN|7.812|||TWO_SIDED|95.0|-6.72|25.14|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||25.14|-6.72|
70944092|NCT01568112|141388091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.84|STANDARD_ERROR_OF_MEAN|4.152|||TWO_SIDED|95.0|-11.31|5.63|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||5.63|-11.31|
71081570|NCT03020550|141670197|SUPERIORITY|||||||0.034|||||||ANOVA|Adjusted for baseline GERD symptom severity.||The outcome measure was calculated using a general linear model with average daily post GERD symptom severity as the dependent variable with the following independent variables: baseline average GERD symptom severity and change in GSR (galvanic skin response). No term for visit type assignment was included in the model.||||0.034
71081571|NCT03020550|141670198|SUPERIORITY|||||||0.56|||||||ANOVA|Adjusted for baseline GERD symptom severity||The outcome measure was calculated using a general linear model with average daily post GERD symptom severity as the dependent variable with the following independent variables: baseline average GERD symptom severity and change in RMSSD (high frequency HRV). No term for visit type assignment was included in the model.||||0.56
70944093|NCT01568112|141388091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.09|STANDARD_ERROR_OF_MEAN|7.516|||TWO_SIDED|95.0|-18.36|12.19|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||12.19|-18.36|
70944094|NCT01568112|141388091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.18|STANDARD_ERROR_OF_MEAN|7.141|||TWO_SIDED|95.0|-20.71|8.35|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||8.35|-20.71|
70944095|NCT01568112|141388091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.21|STANDARD_ERROR_OF_MEAN|5.292|||TWO_SIDED|95.0|-22.9|6.49|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||6.49|-22.90|
70944096|NCT01568112|141388091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.33|STANDARD_ERROR_OF_MEAN|6.536|||TWO_SIDED|95.0|-30.13|11.47|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||11.47|-30.13|
70944097|NCT01568112|141388091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.69|STANDARD_ERROR_OF_MEAN|8.376|||TWO_SIDED|95.0|-30.02|4.63|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||4.63|-30.02|
70944098|NCT01568112|141388091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.58|STANDARD_ERROR_OF_MEAN|8.654|||TWO_SIDED|95.0|-29.48|6.32|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||6.32|-29.48|
71081572|NCT03020550|141670199|SUPERIORITY|||||||0.8|||||||Pearson's correlation test|||The outcome measure was calculated using a Pearson correlation to compare the session index representing the amount of concordance in GSR between patient and physician and the percent change in patients' GERD symptoms. Visit type assignment was not included in the analysis.||||0.80
71081573|NCT03442725|141670213|OTHER||Geometric Mean Ratio|1.297|||||TWO_SIDED|90.0|0.6|2.805||||||Analysis of variance (ANOVA) comparison of Cmax for telotristat ethyl between test group versus the control group.||2.805|0.600|
70944099|NCT01568112|141388091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.93|STANDARD_ERROR_OF_MEAN|10.274|||TWO_SIDED|95.0|-35.44|7.57|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||7.57|-35.44|
70944100|NCT01568112|141388091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.29|STANDARD_ERROR_OF_MEAN|12.369|||TWO_SIDED|95.0|-33.39|18.81|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||18.81|-33.39|
70944101|NCT01568112|141388091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.24|STANDARD_ERROR_OF_MEAN|6.472|||TWO_SIDED|95.0|-20.4|5.93|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||5.93|-20.40|
70944102|NCT01568112|141388091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|60.33|STANDARD_ERROR_OF_MEAN|34.455|||TWO_SIDED|95.0|-10.78|131.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||131.4|-10.78|
70944103|NCT01568112|141388091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|59.87|STANDARD_ERROR_OF_MEAN|65.007|||TWO_SIDED|95.0|-71.51|191.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||191.2|-71.51|
70944104|NCT01568112|141388091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|54.78|STANDARD_ERROR_OF_MEAN|40.44|||TWO_SIDED|95.0|-27.09|136.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||136.6|-27.09|
71081574|NCT03442725|141670213|OTHER||Geometric Mean Ratio|1.423|||||TWO_SIDED|90.0|0.901|2.247||||||ANOVA comparison of Cmax for LP-778902 between test group versus the control group.||2.247|0.901|
71081575|NCT03442725|141670214|OTHER|Estimate of the median difference and 90% confidence intervals (CIs) was determined by Hodges-Lehmann estimation.|Median Difference|0.0||||0.7452|TWO_SIDED|90.0|-1.0|0.95|||Wilcoxon (Mann-Whitney)|||Comparison of tmax for telotristat ethyl between test group versus the control group.||0.950|-1.000|0.7452
71081576|NCT03442725|141670214|OTHER|Estimate of the median difference and 90% CIs was determined by Hodges-Lehmann estimation.|Median Difference|0.0||||0.7039|TWO_SIDED|90.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||Comparison of tmax for LP-778902 between test group versus the control group.||1.000|-1.000|0.7039
71081577|NCT03442725|141670216|OTHER||Geometric Mean Ratio|1.506|||||TWO_SIDED|90.0|0.914|2.48||||||ANOVA comparison of AUC0-inf for LP-778902 between test group versus the control group.||2.480|0.914|
71081578|NCT03442725|141670217|OTHER||Geometric Mean Ratio|1.512|||||TWO_SIDED|90.0|0.915|2.498||||||ANOVA comparison of AUC0-tlast for LP-778902 between test group versus the control group.||2.498|0.915|
71081579|NCT03442725|141670221|OTHER||Arithmetic Mean Difference|0.019|||||TWO_SIDED|90.0|-0.03|0.068||||||ANOVA comparison of fu of LP-778902 between test group versus the control group.||0.068|-0.030|
71081580|NCT03442725|141670222|OTHER||Geometric Mean Ratio|1.727|||||TWO_SIDED|90.0|0.866|3.443||||||ANOVA comparison of Cmaxu for LP-778902 between test group versus the control group.||3.443|0.866|
71081581|NCT03442725|141670223|OTHER||Geometric Mean Ratio|1.828|||||TWO_SIDED|90.0|0.903|3.699||||||ANOVA comparison of AUC0-infu for LP-778902 between test group versus the control group.||3.699|0.903|
71081582|NCT03442725|141670224|OTHER||Geometric Mean Ratio|1.835|||||TWO_SIDED|90.0|0.904|3.726||||||ANOVA comparison of AUC0-tlastu for LP-778902 between test group versus the control group.||3.726|0.904|
71081583|NCT02501161|141670242|OTHER||||||<|0.0001|||||||Stratified log-rank test|||Test for no treatment difference was based on using a stratified log-rank test where treatment, baseline HbA1c group and pre-trial OAD treatment group were included as strata in the model.||||<.0001
71081584|NCT02501161|141670243|OTHER||||||<|0.0001|||||||Stratified log-rank test|||Test for no treatment difference was based on using a stratified log-rank test where treatment, baseline HbA1c group and pre-trial OAD treatment group were included as strata in the model.||||<.0001
71081585|NCT03159299|141670296|SUPERIORITY||Mean Difference (Final Values)|0.11|||<|0.15|TWO_SIDED||||||Mixed Models Analysis|||||||<0.15
71081586|NCT01990573|141670320|OTHER|ANOVA|F statistic|0.002||||0.002|TWO_SIDED||||||ANOVA|||||||.002
71081587|NCT01990573|141670321|OTHER|ANOVA|F statistic|0.962||||0.962|TWO_SIDED||||||ANOVA|||||||.962
71081588|NCT02485483|141670378|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.67|||<|0.001|TWO_SIDED|95.0|0.59|0.74||"Convergent Validity Criterion Correlation coefficient (ρ) \> \|0.50\|"|t-test, 2 sided||Convergent correlation between PHQ-9 and MADRS|Number of participants analyzed (N) = 221||0.74|0.59|<0.001
71081589|NCT02485483|141670378|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.69|||<|0.001|TWO_SIDED|95.0|0.62|0.76||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between PHQ-9 and BDI-II|Number of participants analyzed (N) = 222||0.76|0.62|<0.001
71081590|NCT02485483|141670379|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.58||||0.057|TWO_SIDED|95.0|0.48|0.66||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between PHQ-9 and MADRS|Number of participants analyzed (N) = 203||0.66|0.48|0.057
71081591|NCT02485483|141670379|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.74|||<|0.001|TWO_SIDED|95.0|0.67|0.8||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between PHQ-9 and BDI-II|Number of participants analyzed (N) = 200||0.80|0.67|<0.001
71081592|NCT02485483|141670380|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.73|||<|0.001|TWO_SIDED|95.0|0.67|0.79||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between BDI-II and MADRS|Number of participants analyzed (N) = 258||0.79|0.67|<0.001
71081593|NCT02485483|141670381|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.71|||<|0.001|TWO_SIDED|95.0|0.64|0.77||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between BDI-II and MADRS|Number of participants analyzed (N) = 214||0.77|0.64|<0.001
71081594|NCT02485483|141670382|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.59||||0.034|TWO_SIDED|95.0|-0.67|-0.49||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between WHO-5 and MADRS|Number of participants analyzed (N) = 222||-0.49|-0.67|0.034
71081595|NCT02485483|141670382|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.61||||0.01|TWO_SIDED|95.0|-0.68|-0.52||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between WHO-5 and BDI-II|Number of participants analyzed (N) = 223||-0.52|-0.68|0.010
71081596|NCT02485483|141670382|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.73|||<|0.001|TWO_SIDED|95.0|-0.78|-0.66||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between WHO-5 and PHQ-9|Number of participants analyzed (N) = 222||-0.66|-0.78|<0.001
71081597|NCT02485483|141670383|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.54||||0.219|TWO_SIDED|95.0|-0.63|-0.43||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between WHO-5 and MADRS|Number of participants analyzed (N) = 202||-0.43|-0.63|0.219
71081598|NCT02485483|141670383|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.68|||<|0.001|TWO_SIDED|95.0|-0.75|-0.6||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between WHO-5 and BDI-II|Number of participants analyzed (N) = 199||-0.60|-0.75|<0.001
71081599|NCT02485483|141670383|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.77|||<|0.001|TWO_SIDED|95.0|-0.82|-0.7||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between WHO-5 and PHQ-9|Number of participants analyzed (N) = 205||-0.70|-0.82|<0.001
70944105|NCT01568112|141388092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.95|STANDARD_ERROR_OF_MEAN|5.281|||TWO_SIDED|95.0|-6.79|14.68|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||14.68|-6.79|
70944106|NCT01568112|141388092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.37|STANDARD_ERROR_OF_MEAN|2.563|||TWO_SIDED|95.0|-9.57|0.83|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||0.83|-9.57|
70944107|NCT01568112|141388092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.51|STANDARD_ERROR_OF_MEAN|8.024|||TWO_SIDED|95.0|-2.84|29.86|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||29.86|-2.84|
70944108|NCT01568112|141388092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.44|STANDARD_ERROR_OF_MEAN|2.379|||TWO_SIDED|95.0|-2.41|7.29|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||7.29|-2.41|
70944109|NCT01568112|141388092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.84|STANDARD_ERROR_OF_MEAN|8.143|||TWO_SIDED|95.0|-5.81|27.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||27.50|-5.81|
70944110|NCT01568112|141388092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|4.671|||TWO_SIDED|95.0|-12.08|7.09|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||7.09|-12.08|
70944111|NCT01568112|141388092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69|STANDARD_ERROR_OF_MEAN|8.488|||TWO_SIDED|95.0|-19.03|15.64|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||15.64|-19.03|
70944112|NCT01568112|141388092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.91|STANDARD_ERROR_OF_MEAN|7.832|||TWO_SIDED|95.0|-23.93|8.11|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||8.11|-23.93|
70944113|NCT01568112|141388092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|4.811|||TWO_SIDED|95.0|-23.8|17.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||17.60|-23.80|
70944114|NCT01568112|141388092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.88|STANDARD_ERROR_OF_MEAN|4.155|||TWO_SIDED|95.0|-22.75|13.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||13.00|-22.75|
70944115|NCT01568112|141388092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.08|STANDARD_ERROR_OF_MEAN|16.243|||TWO_SIDED|95.0|-59.2|9.05|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||9.05|-59.20|
71081600|NCT01724177|141670394|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||"A one sample binomial one sided exact test for the ORR (CR, CRu, or PR) was performed to provide the p-value (significance level: 0.05). The hypotheses of interest:~H0: ORR ≤ 5% versus H1: ORR \> 5%"|Exact Test|||||||<0.0001
71081601|NCT04846270|141670437|OTHER|||||||0.0006|||||||Wilcoxon (Mann-Whitney)|A Wilcoxon Signed-Rank test was used to test if the number of manual checks has been reduced.||"POWER is a single arm investigation with cross-over design. Each participating subject will use the study device and act as its own control.~The null hypothesis (H0) is that there is no difference in the mean number of checks performed during the investigation week compared to the baseline week.~The alternate hypothesis (H1) is that there is a reduction in the mean number of checks performed during the investigation week compared to the baseline week."||||0.0006
71081602|NCT04846270|141670439|OTHER|||||||0.0051|||||||Wilcoxon (Mann-Whitney)|A Wilcoxon Signed-Rank test was used to test if the number of leakages had been reduced.||||||0.0051
71081603|NCT04846270|141670442|OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|A Wilcoxon Signed-Rank test was used to test if the number of fecal incidents had been reduced.||||||0.76
71081604|NCT00828061|141670455|SUPERIORITY_OR_OTHER||Geometric Mean Fold Difference|0.25||||0.002||95.0|0.12|0.54||1-sided, alpha = 0.05|ANOVA|Analysis performed on log-transformed fold change from baseline and results were back-transformed for reporting.||||0.54|0.12|0.002
71081605|NCT00828061|141670455|SUPERIORITY_OR_OTHER||Geometric Mean Fold Difference|0.07|||<|0.001||95.0|0.03|0.15||1-sided, alpha = 0.05|ANOVA|Analysis performed on log-transformed fold change from baseline and results were back-transformed for reporting.||||0.15|0.03|<0.001
70944116|NCT01568112|141388092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.95|STANDARD_ERROR_OF_MEAN|14.83|||TWO_SIDED|95.0|-54.89|6.98|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||6.98|-54.89|
70944117|NCT01568112|141388092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.49|STANDARD_ERROR_OF_MEAN|10.847|||TWO_SIDED|95.0|-35.38|10.39|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||10.39|-35.38|
70944118|NCT01568112|141388092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.33|STANDARD_ERROR_OF_MEAN|12.542|||TWO_SIDED|95.0|-32.79|20.13|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||20.13|-32.79|
70944119|NCT01568112|141388092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.73|STANDARD_ERROR_OF_MEAN|6.442|||TWO_SIDED|95.0|-15.87|10.41|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||10.41|-15.87|
70944120|NCT01568112|141388092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|81.89|STANDARD_ERROR_OF_MEAN|50.239|||TWO_SIDED|95.0|-22.04|185.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||185.8|-22.04|
70944121|NCT01568112|141388092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.52|STANDARD_ERROR_OF_MEAN|32.896|||TWO_SIDED|95.0|-40.13|93.18|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||93.18|-40.13|
70944122|NCT01568112|141388092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.78|STANDARD_ERROR_OF_MEAN|41.055|||TWO_SIDED|95.0|-31.65|135.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||135.2|-31.65|
71081606|NCT00828061|141670456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.537||95.0|-15.48|17.26||1-sided, alpha = 0.05|ANOVA|||||17.26|-15.48|0.537
71081607|NCT01400906|141670457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|||||TWO_SIDED|95.0|-0.037|0.38|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.380|-0.037|
71081608|NCT01400906|141670457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|||||TWO_SIDED|95.0|-0.047|0.37|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.370|-0.047|
70944123|NCT01568112|141388093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.68|STANDARD_ERROR_OF_MEAN|2.626|||TWO_SIDED|95.0|-7.35|3.99|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||3.99|-7.35|
70944124|NCT01568112|141388093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|2.18|||TWO_SIDED|95.0|-6.62|2.62|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||2.62|-6.62|
70944125|NCT01568112|141388093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|5.717|||TWO_SIDED|95.0|-11.64|12.49|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||12.49|-11.64|
70944126|NCT01568112|141388093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.48|STANDARD_ERROR_OF_MEAN|4.597|||TWO_SIDED|95.0|-14.11|5.14||||||Diarrhea||5.14|-14.11|
70944127|NCT01568112|141388093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|STANDARD_ERROR_OF_MEAN|0.794|||TWO_SIDED|95.0|-1.1|2.57|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||2.57|-1.10|
70944128|NCT01568112|141388093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.775|||TWO_SIDED|95.0|-1.17|2.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||2.40|-1.17|
70944129|NCT01568112|141388093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|1.705|||TWO_SIDED|95.0|-5.08|2.79|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||2.79|-5.08|
70944130|NCT01568112|141388093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.56|STANDARD_ERROR_OF_MEAN|27.886|||TWO_SIDED|95.0|-42.19|79.32|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||79.32|-42.19|
71081609|NCT01400906|141670462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.638|||||TWO_SIDED|95.0|0.44|0.836|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.836|0.440|
70944131|NCT01568112|141388093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.46|STANDARD_ERROR_OF_MEAN|2.801|||TWO_SIDED|95.0|-3.65|8.56|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||8.56|-3.65|
70944132|NCT01568112|141388093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|1.242|||TWO_SIDED|95.0|-3.71|1.83|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||1.83|-3.71|
70944133|NCT01568112|141388093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.83|STANDARD_ERROR_OF_MEAN|19.649|||TWO_SIDED|95.0|-48.73|60.38|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||60.38|-48.73|
70944134|NCT01568112|141388093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.76|STANDARD_ERROR_OF_MEAN|11.219|||TWO_SIDED|95.0|-28.38|33.91|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||33.91|-28.38|
70944135|NCT01568112|141388093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.36|STANDARD_ERROR_OF_MEAN|9.811|||TWO_SIDED|95.0|-35.56|6.83|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||6.83|-35.56|
70944136|NCT01568112|141388093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|67.12|STANDARD_ERROR_OF_MEAN|41.961|||TWO_SIDED|95.0|-22.88|157.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||157.1|-22.88|
70944137|NCT01568112|141388093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|98.65|STANDARD_ERROR_OF_MEAN|74.566|||TWO_SIDED|95.0|-58.01|255.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||255.3|-58.01|
70944138|NCT01568112|141388093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.27|STANDARD_ERROR_OF_MEAN|7.928|||TWO_SIDED|95.0|-5.22|27.76|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||27.76|-5.22|
70944139|NCT01990313|141388136|SUPERIORITY|||||||0.038|||||||Mixed Models Analysis|||||||0.038
70944140|NCT03511378|141388138|NON_INFERIORITY|Non-inferiority was assessed using a margin of -0.10|Difference in proportions|-0.0296||||0.007|ONE_SIDED|95.0|-0.076||||Difference in proportion|Binomial proportion used to present difference in proportion in treatments||Analysis population : ITT|||-0.076|0.007
70944141|NCT03511378|141388139|NON_INFERIORITY|Noninferiority is assessed using a margin of 10 percentage points.|Difference in proportions|0.0145|||<|0.001|ONE_SIDED|95.0|-0.0092||||Difference in proportion||Difference of proportion analysed with one sided 95% confidence interval|Analysis population: ITT|||-0.0092|<0.001
70944142|NCT00510198|141388172|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|95.0||||The log-rank test was conducted at an alpha level of 0.05. The study was terminated early due to enrollment significantly below protocol expectation. Due to the low sample size and consequently low statistical power, no conclusion can be drawn.|Log Rank|||This is a log-rank test, which uses the time from randomization to first composite endpoint event to compare the risk of event between Access and Control arms.||||0.23
70944143|NCT00510198|141388173|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified non-inferiority margin was 7.5%|Risk Difference (RD)|4.7||||0.36|TWO_SIDED|95.0|-10.9|20.3||The study was terminated early due to enrollment significantly below protocol expectation. Due to the low sample size and consequently low statistical power, no conclusion can be drawn.|Two-sample test of proportions||The risk difference estimate is the difference between the Access Arm and Control arm.|||20.3|-10.9|0.36
70944144|NCT03712449|141388185|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0009|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0009
70944145|NCT03712449|141388185|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.|||||<|0.0001|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||<0.0001
70944146|NCT03712449|141388186|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.7878|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.7878
70944147|NCT03712449|141388186|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0349|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0349
70944148|NCT03712449|141388187|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0043|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0043
70855309|NCT02880956|141198383|SUPERIORITY||LS Mean of Difference|0.21|STANDARD_ERROR_OF_MEAN|0.687||0.758|TWO_SIDED|95.0|-1.139|1.564||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.564|-1.139|0.758
70855310|NCT02880956|141198383|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|5.18|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855311|NCT02880956|141198383|SUPERIORITY||LS Mean of Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.815||0.511|TWO_SIDED|95.0|-2.14|1.066||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.066|-2.140|0.511
70855312|NCT02880956|141198383|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|6.19|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70944149|NCT03712449|141388187|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.|||||<|0.0001|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||<0.0001
71081610|NCT01400906|141670462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.661|||||TWO_SIDED|95.0|0.463|0.859|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.859|0.463|
71081611|NCT01400906|141670463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|||||TWO_SIDED|95.0|0.018|0.333|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.333|0.018|
70855313|NCT02880956|141198383|SUPERIORITY||LS Mean of Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.801||0.192|TWO_SIDED|95.0|-2.623|0.527||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.527|-2.623|0.192
70855314|NCT02880956|141198383|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|6.16|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855315|NCT02880956|141198383|SUPERIORITY||LS Mean of Difference|0.69|STANDARD_ERROR_OF_MEAN|0.816||0.398|TWO_SIDED|95.0|-0.914|2.294||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||2.294|-0.914|0.398
70855316|NCT02880956|141198383|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|5.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70944150|NCT03712449|141388188|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0017|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0017
71081612|NCT01400906|141670463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|||||TWO_SIDED|95.0|0.008|0.323|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.323|0.008|
71081613|NCT01400906|141670464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.476|||||TWO_SIDED|95.0|0.326|0.627|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.627|0.326|
70855317|NCT02880956|141198383|SUPERIORITY||LS Mean of Difference|0.97|STANDARD_ERROR_OF_MEAN|0.924||0.296|TWO_SIDED|95.0|-0.851|2.784||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.784|-0.851|0.296
70855318|NCT02880956|141198383|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|6.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855319|NCT02880956|141198383|SUPERIORITY||LS Mean of Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.907||0.706|TWO_SIDED|95.0|-2.126|1.442||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.442|-2.126|0.706
70944151|NCT03712449|141388188|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.|||||<|0.0001|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||<0.0001
70944152|NCT03712449|141388189|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0105|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0105
71081614|NCT01400906|141670464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53|||||TWO_SIDED|95.0|0.38|0.68|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.680|0.380|
71081615|NCT02384538|141670486|OTHER||LS Mean Difference|1.52||||0.386|TWO_SIDED|95.0|-1.944|4.99||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||||4.990|-1.944|0.386
71081616|NCT02384538|141670488|OTHER||LS Mean Difference|2.55||||0.383|TWO_SIDED|95.0|-3.214|8.308||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||Week 16||8.308|-3.214|0.383
71081617|NCT02384538|141670489|OTHER||LS Mean Difference|0.15||||0.719|TWO_SIDED|95.0|-0.677|0.979||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||Week 16||0.979|-0.677|0.719
71081618|NCT02384538|141670490|OTHER||LS Mean Difference|4.25||||0.387|TWO_SIDED|95.0|-5.448|13.945||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||Week 16||13.945|-5.448|0.387
71081619|NCT02384538|141670491|OTHER||LS Mean Difference|0.45||||0.281|TWO_SIDED|95.0|-0.373|1.272||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||Week 16||1.272|-0.373|0.281
71081620|NCT02384538|141670492|OTHER||LS Mean Difference|0.52||||0.212|TWO_SIDED|95.0|-0.3|1.336||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||Week 16||1.336|-0.300|0.212
71081621|NCT02256917|141670494|OTHER|Confirmative one-sided one-sample Poisson-test.|ABR|4.87|||||TWO_SIDED|95.0|4.06|5.79||A respective confirmative one-sided one-sample Poisson-test was used to demonstrate if the mean ABR in patients with individually tailored prophylaxis is at least 50% below the mean ABR rate in the GENA-01 trial.|one-sided one-sample Poisson-test||A confidence interval of 97.5% for confirmative analysis was also used - the respective upper and lower limit CIs were 3.96-5.93|||5.79|4.06|
71081622|NCT02256917|141670494|OTHER|Reduction of the annualized total bleeding rate (ABR) observed in the GENA-01 study vs. GENA-21B analyzed with a Negative Binomial regression model including a correction for overdispersion.|Rate ratio|11.89|||<|0.0001|TWO_SIDED|95.0|7.5|18.86|||Negative binomial regression model|||||18.86|7.50|<0.0001
71081623|NCT02256917|141670494|OTHER|Reduction of the annualized total bleeding rate (ABR) observed in the GENA-01 study vs. GENA-21B analyzed with a Poisson regression model including a correction for overdispersion.|Rate ratio|10.14|||<|0.0001|TWO_SIDED|95.0|6.12|16.8|||Poisson regression model|||||16.80|6.12|<0.0001
71081624|NCT02256917|141670495|OTHER|A respective confirmative one-sided one-sample Poisson-test was used to demonstrate if the mean spontaneous ABR in patients with individually tailored prophylaxis is at least 50% below the mean ABR rate in the GENA-01 trial.|ABR|3.12|||||TWO_SIDED|95.0|2.48|3.87|||One-sided one-sample Poisso|||||3.87|2.48|
71081625|NCT02256917|141670496|OTHER|A respective confirmative one-sided one-sample Poisson-test was used to demonstrate if the mean ABR in patients with 2x/week prophylaxis or less with individually tailored prophylaxis is at least 50% below the mean ABR rate in the GENA-01 trial.|ABR|5.03|||||TWO_SIDED|95.0|3.9|6.39|||One-sided one-sample Poisson-test||A confidence interval of 97.5% for confirmative analysis was also used - the respective upper and lower limit CIs were 3.76-6.60|||6.39|3.90|
71121062|NCT01340937|141748067|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|-0.34|||||TWO_SIDED|95.0|-1.23|0.32|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.32|-1.23|
70855320|NCT02880956|141198383|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|6.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70944153|NCT03712449|141388189|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.|||||<|0.0001|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||<0.0001
71081626|NCT03280056|141670537|SUPERIORITY||Odds Ratio (OR)|1.33||||0.453|TWO_SIDED|95.0|0.632|2.798|||Chi-squared|||||2.798|0.632|0.453
71081627|NCT03280056|141670538|SUPERIORITY||Odds Ratio (OR)|0.998||||0.997|TWO_SIDED|95.0|0.416|2.395|||Chi-squared|||||2.395|0.416|0.997
71081628|NCT03280056|141670539|SUPERIORITY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.926||0.693|TWO_SIDED|95.0|-1.47|2.2|||Mixed Models Analysis|||||2.20|-1.47|0.693
71081629|NCT03280056|141670540|SUPERIORITY||Mean Difference (Final Values)|1.53|STANDARD_ERROR_OF_MEAN|6.176||0.804|TWO_SIDED|95.0|-10.65|13.72|||ANCOVA|||||13.72|-10.65|0.804
71081630|NCT02144077|141670541|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin of -15%|Difference in Percentage|1.6|||<|0.0001|ONE_SIDED|97.5|-6.5||||Farrington and Manning Test|Difference of proportions|||||-6.5|<0.0001
71081631|NCT00169104|141670575|SUPERIORITY||Mean Difference (Net)|-0.2|||>|0.05|TWO_SIDED|||||t=-0.29|t-test, 2 sided|df=15||T test||||>0.05
71081632|NCT00141518|141670598|SUPERIORITY_OR_OTHER||mean change from baseline|-9.4|STANDARD_DEVIATION|17.5||0.017|TWO_SIDED||||||Wilcoxon tests|||Total Score, Change From Baseline for the Duodopa Naïve group at Month 12 (n=25)||||0.017
71081633|NCT00141518|141670599|SUPERIORITY_OR_OTHER||mean change from baseline|0.02|STANDARD_DEVIATION|0.29||0.919|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 12 (n=25)||||0.919
71081634|NCT00141518|141670600|SUPERIORITY_OR_OTHER||mean change from baseline|0.18|STANDARD_DEVIATION|0.24||0.002|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 12 (n=25)||||0.002
71081635|NCT00141518|141670627|SUPERIORITY_OR_OTHER||mean change from baseline|-6.5|STANDARD_DEVIATION|9.6||0.001|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 0 (n=27)||||0.001
71081636|NCT00141518|141670627|SUPERIORITY_OR_OTHER||mean change from baseline|-9.2|STANDARD_DEVIATION|9.0|<|0.001|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 3 (n=23)||||<0.001
71081637|NCT00141518|141670627|SUPERIORITY_OR_OTHER||mean change from baseline|-5.9|STANDARD_DEVIATION|11.2||0.022|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 6 (n=24)||||0.022
71081638|NCT00141518|141670627|SUPERIORITY_OR_OTHER||mean change from baseline|-7.5|STANDARD_DEVIATION|11.6||0.005|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 9 (n=23)||||0.005
71081639|NCT00141518|141670627|SUPERIORITY_OR_OTHER||mean change from baseline|-5.3|STANDARD_DEVIATION|13.9||0.126|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 12 (n=23)||||0.126
71081640|NCT00141518|141670627|SUPERIORITY_OR_OTHER||mean change from baseline|-5.2|STANDARD_DEVIATION|12.3||0.049|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 18 (n=22)||||0.049
71121063|NCT01340937|141748067|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|0.0|||||TWO_SIDED|95.0|-0.64|0.66|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.66|-0.64|
71081641|NCT00141518|141670627|SUPERIORITY_OR_OTHER||mean change from baseline|-3.1|STANDARD_DEVIATION|9.9||0.203|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 24 (n=21)||||0.203
71081642|NCT00141518|141670627|SUPERIORITY_OR_OTHER||mean change from baseline|0.8|STANDARD_DEVIATION|13.2||0.733|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 30 (n=21)||||0.733
71081643|NCT00141518|141670627|SUPERIORITY_OR_OTHER||mean change from baseline|4.4|STANDARD_DEVIATION|14.3||0.414|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 36 (n=20)||||0.414
71081644|NCT00141518|141670627|SUPERIORITY_OR_OTHER||mean change from baseline|2.3|STANDARD_DEVIATION|14.9||0.534|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Endpoint (n=27)||||0.534
71081645|NCT00141518|141670636|SUPERIORITY_OR_OTHER|||||||0.016|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.016
71081646|NCT00141518|141670636|SUPERIORITY_OR_OTHER|||||||0.188|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.188
71081647|NCT00141518|141670637|SUPERIORITY_OR_OTHER|||||||0.008|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.008
71081648|NCT00141518|141670637|SUPERIORITY_OR_OTHER|||||||0.107|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.107
71081649|NCT00141518|141670638|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.002
71081650|NCT00141518|141670638|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.010
71081651|NCT00141518|141670639|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.048
71081652|NCT00141518|141670639|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.003
71081653|NCT00141518|141670640|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.001
71081654|NCT00141518|141670640|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.003
71081655|NCT00141518|141670641|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||1.000
71081656|NCT00141518|141670641|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.002
71081657|NCT00141518|141670642|SUPERIORITY_OR_OTHER|||||||0.017|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.017
71081658|NCT00141518|141670642|SUPERIORITY_OR_OTHER|||||||0.191|||||||Wilcoxon tests|||||||0.191
71081659|NCT00141518|141670643|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.002
71081660|NCT00141518|141670643|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||<0.001
71081661|NCT00141518|141670644|SUPERIORITY_OR_OTHER|||||||0.047|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.047
71081662|NCT00141518|141670644|SUPERIORITY_OR_OTHER|||||||0.847|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.847
71081663|NCT00141518|141670645|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.012
71081664|NCT00141518|141670645|SUPERIORITY_OR_OTHER|||||||0.035|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.035
71081665|NCT00141518|141670646|SUPERIORITY_OR_OTHER|||||||0.599|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.599
71081666|NCT00141518|141670646|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.048
71081667|NCT00141518|141670647|SUPERIORITY_OR_OTHER|||||||0.026|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.026
71081668|NCT00141518|141670647|SUPERIORITY_OR_OTHER|||||||0.208|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.208
71081669|NCT00141518|141670648|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.010
71081670|NCT00141518|141670648|SUPERIORITY_OR_OTHER|||||||0.073|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.073
71081671|NCT00141518|141670649|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.048
71081672|NCT00141518|141670649|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.030
71081673|NCT00141518|141670650|SUPERIORITY_OR_OTHER|||||||0.208|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.208
71081674|NCT00141518|141670650|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.048
71081675|NCT01806168|141670659|OTHER|||||||0.046|||||||Mixed Models Analysis|||||||0.046
71081676|NCT01806168|141670659|EQUIVALENCE|a \< 0.05||||||0.021|||||||t-test, 2 sided|||||||0.021
71081677|NCT01806168|141670659|EQUIVALENCE|a \< 0.05||||||0.65|||||||t-test, 2 sided|||||||0.65
71081678|NCT01806168|141670660|OTHER|||||||0.93|||||||Mixed Models Analysis|||To test primary and secondary outcomes, we utilized intention to treat data and linear mixed models with a group random effect. Significance was set to a \< 0.05.||||0.93
71081679|NCT01806168|141670661|OTHER|||||||0.18|||||||Mixed Models Analysis|||||||0.18
71081680|NCT01806168|141670662|OTHER|||||||0.54|||||||Mixed Models Analysis|||||||0.54
71081681|NCT01806168|141670663|OTHER|||||||0.86|||||||Mixed Models Analysis|||||||0.86
71081682|NCT01806168|141670664|OTHER|||||||0.4|||||||Mixed Models Analysis|||||||0.4
71081683|NCT01100723|141670678|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||McNemar|||Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with PTH values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.||||< 0.05
71121064|NCT01340937|141748067|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|0.92|||<|0.001|TWO_SIDED|95.0|0.2|2.9|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||2.90|0.20|<0.001
71121065|NCT01340937|141748068|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|0.25|||||TWO_SIDED|95.0|-3.74|4.24|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||4.24|-3.74|
71121066|NCT01340937|141748068|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|-1.35|||||TWO_SIDED|95.0|-5.26|2.57|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||2.57|-5.26|
71081684|NCT01100723|141670679|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||McNemar|||Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with phosphorus values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.||||<0.05
71081685|NCT01100723|141670680|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||McNemar|||Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with PTH values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.||||< 0.05
71081686|NCT01100723|141670681|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||McNemar|||Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with phosphorus values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.||||< 0.05
71081687|NCT01100723|141670682|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||McNemar|||Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with Ca values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.||||< 0.05
71081688|NCT01100723|141670683|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||McNemar|||Proportion of subjects on specified medications were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects on the specified medications was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.||||< 0.05
71081689|NCT03066778|141670685|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.00069|TWO_SIDED|95.0|0.6|0.88|||Log Rank|One-sided p-value based on log-rank test stratified by platinum chemotherapy, ECOG, and LDH|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by platinum chemotherapy, ECOG, and LDH|||0.88|0.60|0.00069
71081690|NCT03066778|141670686|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.01643|TWO_SIDED|95.0|0.64|0.98|||Log Rank|One-sided p-value based on log-rank test stratified by platinum chemotherapy, ECOG, and LDH|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by platinum chemotherapy, ECOG, and LDH|||0.98|0.64|0.01643
71121067|NCT01340937|141748068|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-1.64|||||TWO_SIDED|95.0|-5.56|2.28|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||2.28|-5.56|
71121068|NCT01340937|141748068|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|-2.35|||<|0.001|TWO_SIDED|95.0|-6.02|2.09|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||2.09|-6.02|<0.001
71121069|NCT01340937|141748069|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot B)|-0.16|||||TWO_SIDED|95.0|-0.91|0.47|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.47|-0.91|
71081691|NCT03066778|141670687|SUPERIORITY||Percent Difference|8.9||||0.0227|TWO_SIDED|95.0|0.2|17.4|||Miettinen & Nurminen|One-sided p-value for testing. H0: difference in percent = 0 versus H1: difference in percent \> 0.|Based on Miettinen \& Nurminen method stratified by platinum chemotherapy, ECOG, and LDH. Cisplatin, ECOG 0, LDH ≤ULN and Cisplatin, ECOG 0, LDH \>ULN were combined into one stratum because of small sample size|||17.4|0.2|0.02270
71081692|NCT03066778|141670692|OTHER||Difference in Least Square Means|4.43||||0.04|TWO_SIDED|95.0|0.21|8.66|||Log Rank|||||8.66|0.21|0.040
71081693|NCT03066778|141670695|OTHER||Hazard Ratio (HR)|0.8||||0.208|TWO_SIDED|95.0|0.56|1.14|||Log Rank|Two-sided p-value based on stratified log-rank test|Based on Cox regression model with treatment as a covariate stratified by platinum chemotherapy ECOG, and LDH. Cisplatin, ECOG 0, LDH ≤ULN and Cisplatin, ECOG 0, LDH \>ULN were combined into one stratum because of small sample size|||1.14|0.56|0.208
71081694|NCT03665077|141670712|OTHER|Linear mixed-effect model of log-transformed oxylipin level, with time (date) as a continuous variable, adjusted for batch and clustered on participant||||||0.684|||||||Mixed Models Analysis|Linear mixed-effect model of log-transformed oxylipin level: time (date) as a continuous variable, adjusted for batch and clustered on participant||||||0.684
71081695|NCT03665077|141670713|OTHER|Linear mixed-effect model of log-transformed oxylipin level, with time (date) as a continuous variable, adjusted for batch and clustered on participant||||||0.02|||||||Mixed Models Analysis|Linear mixed-effect model of log-transformed oxylipin level: time (date) as a continuous variable, adjusted for batch and clustered on participant||||||0.02
71081696|NCT03665077|141670714|OTHER|Linear mixed-effect model of log-transformed oxylipin level: time (date) as a continuous variable, adjusted for batch and clustered on participant||||||0.058|||||||Mixed Models Analysis|Linear mixed-effect model of log-transformed oxylipin level: time (date) as a continuous variable, adjusted for batch and clustered on participant||||||0.058
71081697|NCT00237692|141670722|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|59.8|||||TWO_SIDED|95.0|55.7|63.9|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at Baseline||63.9|55.7|
71081698|NCT00237692|141670722|SUPERIORITY_OR_OTHER||Est. % of patients with controled SBP|59.8|||||TWO_SIDED|95.0|55.7|64.0|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at Baseline||64.0|55.7|
70855321|NCT02880956|141198383|SUPERIORITY||LS Mean of Difference|1.79|STANDARD_ERROR_OF_MEAN|0.929||0.055|TWO_SIDED|95.0|-0.036|3.617||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||3.617|-0.036|0.055
70855322|NCT02880956|141198383|SUPERIORITY||Effect size/pooled SD|-0.28|STANDARD_DEVIATION|6.45|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70944154|NCT03712449|141388190|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0004|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0004
71081699|NCT00237692|141670722|SUPERIORITY_OR_OTHER||Est. % of patinets with controlled SBP|59.8|||||TWO_SIDED|95.0|55.6|63.9|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled BP at Baseline||63.9|55.6|
71081700|NCT00237692|141670722|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|59.8|||||TWO_SIDED|95.0|55.6|63.9|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at Baseline||63.9|55.6|
71081701|NCT00237692|141670723|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|58.0|||||TWO_SIDED|95.0|49.3|66.7|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at 6 months.||66.7|49.3|
71081702|NCT00237692|141670723|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|60.9|||||TWO_SIDED|95.0|52.5|69.3|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 6 months.||69.3|52.5|
71081703|NCT00237692|141670723|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|65.0|||||TWO_SIDED|95.0|56.9|73.1|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 6 months.||73.1|56.9|
71081704|NCT00237692|141670723|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|63.8|||||TWO_SIDED|95.0|55.6|72.0|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 6 months.||72.0|55.6|
71081705|NCT00237692|141670723|SUPERIORITY_OR_OTHER||% diff|2.9|||||TWO_SIDED|95.0|-9.0|14.9|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Nurse Behavioral and Arm 1 - Control at 6months.||14.9|-9.0|
71081706|NCT00237692|141670723|SUPERIORITY_OR_OTHER||% Diff|6.9|||||TWO_SIDED|95.0|-4.7|18.7|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Nurse Med Management and Arm 1 - Control at 6months.||18.7|-4.7|
71081707|NCT00237692|141670723|SUPERIORITY_OR_OTHER||% Diff|5.7|||||TWO_SIDED|95.0|-6.0|17.6||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Combined Behavioral \& Med Mgmt and Arm 1 - Control at 6months.||17.6|-6.0|
71081708|NCT00237692|141670724|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|59.9|||||TWO_SIDED|95.0|51.4|68.3|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 12 months.||68.3|51.4|
71081709|NCT00237692|141670724|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|73.1|||||TWO_SIDED|95.0|65.6|80.7|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 12 months||80.7|65.6|
71081710|NCT00237692|141670724|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|73.4|||||TWO_SIDED|95.0|66.1|80.7|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 12 months.||80.7|66.1|
71081711|NCT00237692|141670724|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|68.6|||||TWO_SIDED|95.0|60.5|76.6|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at 12 months.||76.6|60.5|
71081712|NCT00237692|141670724|SUPERIORITY_OR_OTHER||% Diff|13.2|||||TWO_SIDED|95.0|2.0|24.4||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Nurse Behavioral and Arm 1 - Control at 12 months.||24.4|2.0|
71081713|NCT00237692|141670724|SUPERIORITY_OR_OTHER||% Diff|13.5|||||TWO_SIDED|95.0|2.4|24.6||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 3 - Nurse Med Management and Arm 1 - Control at 12 months.||24.6|2.4|
70944155|NCT03712449|141388190|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.|||||<|0.0001|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||<.0001
70944156|NCT03712449|141388195|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0005|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0005
70944157|NCT03712449|141388195|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.|||||<|0.0001|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||<0.0001
71081714|NCT00237692|141670724|SUPERIORITY_OR_OTHER||% diff|8.6|||||TWO_SIDED|95.0|-2.9|20.2||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 4 - Combined Behavioral \& Med Mgmt and Arm 1 - Control at 12 months.||20.2|-2.9|
71081715|NCT00237692|141670725|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|61.8|||||TWO_SIDED|95.0|53.0|70.6|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at 18 months||70.6|53.0|
71081716|NCT00237692|141670725|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|59.4|||||TWO_SIDED|95.0|50.8|67.9|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled BP at 18 months||67.9|50.8|
71081717|NCT00237692|141670725|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|63.5|||||TWO_SIDED|95.0|55.1|72.0|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 18 months.||72.0|55.1|
71081718|NCT00237692|141670725|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|71.6|||||TWO_SIDED|95.0|63.7|79.5|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 18 months||79.5|63.7|
71081719|NCT00237692|141670725|SUPERIORITY_OR_OTHER||% Diff|-2.4|||||TWO_SIDED|95.0|-14.6|9.7||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Nurse Behavioral and Arm 1 - Control at 18 months.||9.7|-14.6|
71081720|NCT00237692|141670725|SUPERIORITY_OR_OTHER||% Diff|1.7|||||TWO_SIDED|95.0|-10.3|13.8||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 3 - Nurse Med Management and Arm 1 - Control at 18 months.||13.8|-10.3|
71081721|NCT00237692|141670725|SUPERIORITY_OR_OTHER||% Diff|9.8|||||TWO_SIDED|95.0|-1.9|21.4||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 4 - Combined Behavioral \& Med Mgmt and Arm 1 - Control at 18 months.||21.4|-1.9|
71081722|NCT00237692|141670727|SUPERIORITY_OR_OTHER||Est. % Diff in Patient w/Controlled SBP|2.0|||||TWO_SIDED|95.0|-3.1|7.1|||||Systolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in systolic blood pressure at 12months between Arm 1 - Control and Arm 2 - Nurse Behavioral||7.1|-3.1|
70855323|NCT02880956|141198384|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.11||0.651|TWO_SIDED|95.0|-0.266|0.166||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.166|-0.266|0.651
70855324|NCT02880956|141198384|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|0.82|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855325|NCT02880956|141198384|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.107||0.32|TWO_SIDED|95.0|-0.318|0.104||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.104|-0.318|0.320
70855326|NCT02880956|141198384|SUPERIORITY||Effect size/pooled SD|0.13|STANDARD_DEVIATION|0.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855327|NCT02880956|141198384|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.11||0.757|TWO_SIDED|95.0|-0.25|0.182||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.182|-0.250|0.757
70855328|NCT02880956|141198384|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|0.83|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855329|NCT02880956|141198384|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.121||0.984|TWO_SIDED|95.0|-0.241|0.236||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.236|-0.241|0.984
70855330|NCT02880956|141198384|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|0.85|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855331|NCT02880956|141198384|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.118||0.595|TWO_SIDED|95.0|-0.296|0.17||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.170|-0.296|0.595
70855332|NCT02880956|141198384|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|0.93|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855333|NCT02880956|141198384|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.122||0.67|TWO_SIDED|95.0|-0.187|0.291||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.291|-0.187|0.670
70855334|NCT02880956|141198384|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|0.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855335|NCT02880956|141198385|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.112||0.722|TWO_SIDED|95.0|-0.26|0.18||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.180|-0.260|0.722
70855336|NCT02880956|141198385|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|0.86|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855337|NCT02880956|141198385|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.109||0.878|TWO_SIDED|95.0|-0.232|0.198||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.198|-0.232|0.878
70855338|NCT02880956|141198385|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855339|NCT02880956|141198385|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.112||0.535|TWO_SIDED|95.0|-0.151|0.29||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.290|-0.151|0.535
70855340|NCT02880956|141198385|SUPERIORITY||Effect size/pooled SD|-0.09|STANDARD_DEVIATION|0.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855341|NCT02880956|141198385|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_ERROR_OF_MEAN|0.129||0.916|TWO_SIDED|95.0|-0.266|0.239||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.239|-0.266|0.916
70855342|NCT02880956|141198385|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|0.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855343|NCT02880956|141198385|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.126||0.511|TWO_SIDED|95.0|-0.33|0.165||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.165|-0.330|0.511
70855344|NCT02880956|141198385|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|1.0|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855345|NCT02880956|141198385|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.129||0.771|TWO_SIDED|95.0|-0.217|0.292||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.292|-0.217|0.771
70944158|NCT01649297|141388209|NON_INFERIORITY_OR_EQUIVALENCE|"Null hypotheses for non-inferiority:~H10: Mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 5 mg twice daily ≥ mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 10 mg once daily + 0.35%~H20: Mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 12.5 mg twice daily ≥ mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 25 mg once daily + 0. 35%"|Adjusted mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|-0.16|0.13||The two non-inferiority hypotheses H10 and H20 were tested using the Hochberg procedure in order to control the family-wise type I error at 0.025 (one-sided).|ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR \[MDRD\] value)- fixed effects and baseline HbA1c- linear covariate.||The primary objective was to test the non-inferiority of empagliflozin 5 mg BID versus empagliflozin 10 mg QD, and non-inferiority of empagliflozin 12.5 mg BID versus empagliflozin 25 mg QD, assuming a non-inferiority margin of 0.35%||0.13|-0.16|<0.0001
70944159|NCT01649297|141388209|NON_INFERIORITY_OR_EQUIVALENCE|"Null hypotheses for non-inferiority:~H10: Mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 5 mg twice daily ≥ mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 10 mg once daily + 0.35%~H20: Mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 12.5 mg twice daily ≥ mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 25 mg once daily + 0. 35%"|Adjusted mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|-0.26|0.03||The two non-inferiority hypotheses H10 and H20 were tested using the Hochberg procedure in order to control the family-wise type I error at 0.025 (one-sided).|ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR \[MDRD\] value)- fixed effects and baseline HbA1c- linear covariate.||The primary objective was to test the non-inferiority of empagliflozin 5 mg BID versus empagliflozin 10 mg QD, and non-inferiority of empagliflozin 12.5 mg BID versus empagliflozin 25 mg QD, assuming a non-inferiority margin of 0.35%||0.03|-0.26|<0.0001
70944160|NCT01649297|141388209|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.79|-0.44|||ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR \[MDRD\] value)- fixed effects and baseline HbA1c- linear covariate.||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing HbA1c after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided).||-0.44|-0.79|<0.0001
70944161|NCT01649297|141388209|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.68|-0.32|||ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR \[MDRD\] value)- fixed effects and baseline HbA1c- linear covariate.||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing HbA1c after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided).||-0.32|-0.68|<0.0001
70944162|NCT01649297|141388209|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.62|-0.27|||ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR \[MDRD\] value)- fixed effects and baseline HbA1c- linear covariate.||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing HbA1c after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided).||-0.27|-0.62|<0.0001
70944163|NCT01649297|141388209|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.6|-0.25|||ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR \[MDRD\] value)- fixed effects and baseline HbA1c- linear covariate.||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing HbA1c after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided).||-0.25|-0.60|<0.0001
70944164|NCT01649297|141388210|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.6|STANDARD_ERROR_OF_MEAN|2.8||||95.0|-9.0|1.8|||ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening (eGFR)\[MDRD\]value)-fixed effects and baseline HbA1c,baseline FPG-linear covariates||||1.8|-9.0|
70944165|NCT01649297|141388210|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.0|STANDARD_ERROR_OF_MEAN|2.8||||95.0|-10.4|0.5||The two non-inferiority hypotheses H10 and H20 were tested using the Hochberg procedure in order to control the family-wise type I error at 0.025 (one-sided).|ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening (eGFR)\[MDRD\]value)-fixed effects and baseline HbA1c,baseline FPG-linear covariates||||0.5|-10.4|
70954275|NCT00688870|141411080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.477||95.0|||||Fisher Exact|||For Redness - Moderate, Fisher exact test was used to calculate p-value.||||0.477
70954276|NCT00688870|141411081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.633||95.0|||||Fisher Exact|||For Fever \>=38 but \<=39 degrees C, Fisher exact test was used to calculate p-value.||||0.633
70855346|NCT02880956|141198385|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|0.94|||TWO_SIDED|||||||||Week 96||||
70855347|NCT02880956|141198386|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.086||0.903|TWO_SIDED|95.0|-0.159|0.18||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.180|-0.159|0.903
71081723|NCT00237692|141670727|SUPERIORITY_OR_OTHER||Est. Dif in Patient w/Controlled DBP|0.5|||||TWO_SIDED|95.0|-2.7|3.8|||||Diastolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in diastolic blood pressure at 12months between Arm 1 - Control and Arm 2 - Nurse Behavioral||3.8|-2.7|
71081724|NCT00237692|141670727|SUPERIORITY_OR_OTHER||Est. % Diff in Patient w/Controlled SBP|0.4|||||TWO_SIDED|95.0|-4.8|5.5|||||Systolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in systolic blood pressure at 12months between Arm 1 - Control and Arm 3 - Nurse Med Management.||5.5|-4.8|
71081725|NCT00237692|141670727|SUPERIORITY_OR_OTHER||Est. % Diff in Patient w/Controlled DBP|0.7|||||TWO_SIDED|95.0|-2.6|4.0|||||Diastolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in diastolic blood pressure at 12months between Arm 1 - Control and Arm 3 - Nuse Med Management||4.0|-2.6|
71081726|NCT00237692|141670727|SUPERIORITY_OR_OTHER||Est. % Diff in Patient w/Controlled SBP|1.6|||||TWO_SIDED|95.0|-3.3|6.6|||||Systolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in systolic blood pressure at 12months between Arm 1 - Control and Arm 4 - Combined Behaviorial and Med Management||6.6|-3.3|
71081727|NCT00237692|141670727|SUPERIORITY_OR_OTHER||Est. % Diff in Patient w/Controlled DBP|3.4|||||TWO_SIDED|95.0|0.3|6.6|||||Diastolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in diastolic blood pressure at 12months between Arm 1 - Control and Arm 4 - Combined Behaviorial and Med Management||6.6|0.3|
71081728|NCT00685360|141670735|SUPERIORITY||Risk Ratio Mean|1.534|||=|0.0083|TWO_SIDED|95.0|1.107|2.124|||Cochran-Mantel-Haenszel|P-value was derived using Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata (cavitation).||||2.124|1.107|=0.0083
71081729|NCT00685360|141670735|SUPERIORITY||Risk Ratio Mean|1.416|||=|0.0393|TWO_SIDED|95.0|1.012|1.98||P-value was derived using CMH test stratified by randomization strata (cavitation).|Cochran-Mantel-Haenszel|||||1.980|1.012|=0.0393
70855348|NCT02880956|141198386|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|0.63|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70954277|NCT00688870|141411081|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Fever \>39 but \<=40 degrees C, Fisher exact test was used to calculate p-value.||||>0.99
70954278|NCT00688870|141411081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.527||95.0|||||Fisher Exact|||For Decreased appetite, Fisher exact test was used to calculate p-value.||||0.527
70954279|NCT00688870|141411081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.613||95.0|||||Fisher Exact|||For Irritability, Fisher exact test was used to calculate p-value.||||0.613
71081730|NCT00685360|141670747|SUPERIORITY||Risk Ratio Mean|1.599|||=|0.0021|TWO_SIDED|95.0|1.175|2.177|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||2.177|1.175|=0.0021
71081731|NCT00685360|141670747|SUPERIORITY||Risk Ratio Mean|1.939|||<|0.0001|TWO_SIDED|95.0|1.449|2.595|||Cochran-Mantel-Haenszel|||||2.595|1.449|<.0001
71081732|NCT00685360|141670748|SUPERIORITY||||||=|0.2419|TWO_SIDED||||||ANCOVA|Pairwise comparison was derived from analysis of covariance(ANCOVA)model with factors of treatment, baseline cavitation status and covariate baseline.||||||=0.2419
71081733|NCT00685360|141670748|SUPERIORITY||||||=|0.2239|TWO_SIDED||||||ANCOVA|Pairwise comparison is derived from ANCOVA model with factors of treatment, baseline cavitation status and covariate baseline.||||||=0.2239
71081734|NCT00685360|141670748|SUPERIORITY||||||=|0.9544|TWO_SIDED||||||ANCOVA|Pairwise comparison is derived from ANCOVA model with factors of treatment, baseline cavitation status and covariate baseline.||||||=0.9544
71081735|NCT00685360|141670749|SUPERIORITY||||||=|0.0246|TWO_SIDED||||||ANCOVA|Pairwise comparison was derived from ANCOVA model with factors of treatment, baseline cavitation status and covariate baseline.||||||=0.0246
71081736|NCT00685360|141670749|SUPERIORITY||||||=|0.0529|TWO_SIDED||||||ANCOVA|Pairwise comparison was derived from ANCOVA model with factors of treatment, baseline cavitation status and covariate baseline.||||||=0.0529
71081737|NCT00685360|141670749|SUPERIORITY||||||=|0.7508|TWO_SIDED||||||ANCOVA|Pairwise comparison was derived from ANCOVA model with factors of treatment, baseline cavitation status and covariate baseline.||||||=0.7508
71081738|NCT00685360|141670750|SUPERIORITY||Risk Ratio Mean|1.272|||=|0.0518|TWO_SIDED|95.0|0.995|1.627|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.627|0.995|=0.0518
71081739|NCT00685360|141670750|SUPERIORITY||Risk Ratio Mean|1.203|||=|0.1506|TWO_SIDED|95.0|0.934|1.55|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.550|0.934|=0.1506
71081740|NCT00685360|141670751|SUPERIORITY||Risk Ratio Mean|1.234|||=|0.1201|TWO_SIDED|95.0|0.945|1.612|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.612|0.945|=0.1201
70855349|NCT02880956|141198386|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.084||0.811|TWO_SIDED|95.0|-0.185|0.145||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.145|-0.185|0.811
70855350|NCT02880956|141198386|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|0.61|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70954280|NCT00688870|141411081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.753||95.0|||||Fisher Exact|||For Increased sleep, Fisher exact test was used to calculate p-value.||||0.753
70855351|NCT02880956|141198386|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.086||0.775|TWO_SIDED|95.0|-0.145|0.194||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.194|-0.145|0.775
70855352|NCT02880956|141198386|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|0.62|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855353|NCT02880956|141198386|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.11||0.273|TWO_SIDED|95.0|-0.337|0.096||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.096|-0.337|0.273
70855354|NCT02880956|141198386|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|0.73|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70954281|NCT00688870|141411081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.748||95.0|||||Fisher Exact|||For Decreased sleep, Fisher exact test was used to calculate p-value.||||0.748
70855355|NCT02880956|141198386|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.108||0.74|TWO_SIDED|95.0|-0.248|0.176||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.176|-0.248|0.740
70855356|NCT02880956|141198386|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|0.8|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855357|NCT02880956|141198386|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.111||0.567|TWO_SIDED|95.0|-0.282|0.155||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.155|-0.282|0.567
70855358|NCT02880956|141198386|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|0.8|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855359|NCT02880956|141198387|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.099||0.931|TWO_SIDED|95.0|-0.204|0.187||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.187|-0.204|0.931
70855360|NCT02880956|141198387|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|0.73|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855361|NCT02880956|141198387|SUPERIORITY||LS Mean of Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.097||0.187|TWO_SIDED|95.0|-0.32|0.063||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.063|-0.320|0.187
71081741|NCT00685360|141670751|SUPERIORITY||Risk Ratio Mean|1.099|||=|0.5112|TWO_SIDED|95.0|0.829|1.456|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.456|0.829|=0.5112
71081742|NCT00685360|141670752|SUPERIORITY||Risk Ratio Mean|1.323|||=|0.0141|TWO_SIDED|95.0|1.053|1.661|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.661|1.053|=0.0141
71081743|NCT00685360|141670752|SUPERIORITY||Risk Ratio Mean|1.438|||=|0.0008|TWO_SIDED|95.0|1.155|1.791|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.791|1.155|=0.0008
71081744|NCT00685360|141670753|SUPERIORITY||Risk Ratio Mean|1.341|||=|0.0196|TWO_SIDED|95.0|1.044|1.722|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.722|1.044|=0.0196
71081745|NCT00685360|141670753|SUPERIORITY||Risk Ratio Mean|1.503|||=|0.0006|TWO_SIDED|95.0|1.183|1.909|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.909|1.183|=0.0006
71081746|NCT00685360|141670754|SUPERIORITY||||||=|0.0468|||||||Cochran-Armitage Linear Trend Test|Cochran-Armitage test was performed for dose response with the treatment group ordered as placebo, delamanid 100 mg BID, and delamanid 200 mg BID.||||||=0.0468
71081747|NCT00685360|141670755|SUPERIORITY||Hazard Ratio (HR)|1.856|||=|0.0011|TWO_SIDED|95.0|1.255|2.745|||Stratified Log-Rank Test|p-value was derived from log-rank test with SAS Proc lifetest for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||2.745|1.255|=0.0011
71081748|NCT00685360|141670755|SUPERIORITY||Hazard Ratio (HR)|1.849|||=|0.0013|TWO_SIDED|95.0|1.246|2.743|||Stratified Log-Rank Test|p-value was derived from log-rank test with SAS Proc lifetest for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||2.743|1.246|=0.0013
71081749|NCT00685360|141670756|SUPERIORITY||Hazard Ratio (HR)|1.926|||=|0.0004|TWO_SIDED|95.0|1.315|2.82|||Stratified Log-Rank Test|P-value was derived from Log-rank test with SAS PROC LIFETEST for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||2.820|1.315|=0.0004
71081750|NCT00685360|141670756|SUPERIORITY||Hazard Ratio (HR)|2.19|||<|0.0001|TWO_SIDED|95.0|1.504|3.189|||Stratified Log-Rank Test|||||3.189|1.504|<.0001
71081751|NCT00685360|141670757|SUPERIORITY||Hazard Ratio (HR)|1.727|||=|0.0056|TWO_SIDED|95.0|1.152|2.591|||Stratified Log-Rank Test|P-value was derived from Log-rank test with SAS PROC LIFETEST for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||2.591|1.152|=0.0056
71081752|NCT00685360|141670757|SUPERIORITY||Hazard Ratio (HR)|1.585|||=|0.0232|TWO_SIDED|95.0|1.048|2.399|||Stratified Log-Rank Test|P-value was derived from Log-rank test with SAS PROC LIFETEST for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||2.399|1.048|=0.0232
71081753|NCT00685360|141670758|SUPERIORITY||Hazard Ratio (HR)|1.846|||=|0.0016|TWO_SIDED|95.0|1.235|2.759|||Stratified Log-Rank Test|P-value was derived from log-rank test with SAS PROC LIFETEST for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||2.759|1.235|=0.0016
71081754|NCT00685360|141670758|SUPERIORITY||Hazard Ratio (HR)|2.301|||<|0.0001|TWO_SIDED|95.0|1.555|3.405|||Stratified Log-Rank Test|P-value was derived from Log-rank test with SAS PROC LIFETEST for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||3.405|1.555|<.0001
71081755|NCT03654729|141670778|SUPERIORITY||Risk Ratio (RR)|1.3842||||0.2266|TWO_SIDED|95.0|0.8172|2.3446|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel estimate of the common relative risk of moderate to severe CIPN.||2.3446|0.8172|0.2266
71081756|NCT03654729|141670778|SUPERIORITY||Risk Ratio (RR)|1.0951||||0.7434|TWO_SIDED|95.0|0.6356|1.887|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel estimate of the common relative risk of moderate to severe CIPN.||1.8870|0.6356|0.7434
71081757|NCT01563198|141670790|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Change in Non-completion Rate of MRI Scans From Baseline at Average of One Year (All Schedule Patients)||||<0.0001
71081758|NCT01563198|141670791|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71081759|NCT01563198|141670792|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71081760|NCT01000974|141670793|NON_INFERIORITY|To demonstrate the non-inferiority of Test Hib to Control Hib, each co-administered with DTPa-HBV-IPV, 13Pn and HRV vaccines, following 3 primary vaccine doses in terms of anti-PRP antibody concentration ≥ 1.0 μg/mL.|difference in percentage|-8.59|||||TWO_SIDED|95.0|-12.28|-4.07|||Non-inferiority analysis|||Non-inferiority Anti-PRP concentration ≥ 1.0 μg/mL||-4.07|-12.28|
71081761|NCT01000974|141670793|NON_INFERIORITY|To demonstrate the non-inferiority of Test Hib to Control Hib, each co-administered with DTPa-HBVIPV, 13Pn and HRV vaccines, following 3 primary vaccine doses in terms of anti-PRP antibody concentrations ≥ 0.15 μg/mL.|Difference in percentage|-0.11|||||TWO_SIDED|95.0|-1.98|2.82|||Non-inferiority analysis|||Non-inferiority Anti-PRP concentration≥ 0.15 μg/mL||2.82|-1.98|
70855362|NCT02880956|141198387|SUPERIORITY||Effect size/pooled SD|0.16|STANDARD_DEVIATION|0.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855363|NCT02880956|141198387|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.961|TWO_SIDED|95.0|-0.191|0.201||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.201|-0.191|0.961
71081762|NCT01000974|141670794|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to diphtheria (Anti-D).|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.26|1.81|||Non-inferiority analysis|||Non-inferiority Anti-D antibody concentrations||1.81|-1.26|
70855364|NCT02880956|141198387|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|0.73|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855365|NCT02880956|141198387|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.124||0.894|TWO_SIDED|95.0|-0.26|0.227||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.227|-0.260|0.894
70855366|NCT02880956|141198387|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|0.87|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855367|NCT02880956|141198387|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.121||0.917|TWO_SIDED|95.0|-0.226|0.251||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.251|-0.226|0.917
70855368|NCT02880956|141198387|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|0.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855369|NCT02880956|141198387|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.124||0.639|TWO_SIDED|95.0|-0.186|0.303||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.303|-0.186|0.639
70855370|NCT02880956|141198387|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|0.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855371|NCT02880956|141198388|SUPERIORITY||LS Mean of Difference|-1.57|STANDARD_ERROR_OF_MEAN|2.175||0.47|TWO_SIDED|95.0|-5.851|2.703||The statistical model: UPSA-Brief change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.703|-5.851|0.470
70855372|NCT02880956|141198388|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|15.44|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855373|NCT02880956|141198388|SUPERIORITY||LS Mean of Difference|0.36|STANDARD_ERROR_OF_MEAN|2.127||0.864|TWO_SIDED|95.0|-3.819|4.548||The statistical model: UPSA-Brief change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||4.548|-3.819|0.864
70855374|NCT02880956|141198388|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|15.95|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855375|NCT02880956|141198388|SUPERIORITY||LS Mean of Difference|-4.49|STANDARD_ERROR_OF_MEAN|2.206||0.043|TWO_SIDED|95.0|-8.826|-0.15||The statistical model: UPSA-Brief change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||-0.150|-8.826|0.043
70855376|NCT02880956|141198388|SUPERIORITY||Effect size/pooled SD|-0.28|STANDARD_DEVIATION|16.24|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855377|NCT02880956|141198388|SUPERIORITY||LS Mean of Difference|0.61|STANDARD_ERROR_OF_MEAN|2.874||0.831|TWO_SIDED|95.0|-5.041|6.27||The statistical model: UPSA-Brief change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||6.270|-5.041|0.831
70855378|NCT02880956|141198388|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|18.06|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70954282|NCT00688870|141411082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.327||95.0|||||Fisher Exact|||For Fever \>=38 but \<=39 degrees C, Fisher exact test was used to calculate p-value.||||0.327
71081763|NCT01000974|141670794|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to tetanus (Anti-T).|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.26|1.8|||Non-inferiority analysis|||Non-inferiority Anti-T antibody concentrations||1.8|-1.26|
71081764|NCT01000974|141670796|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to pertussis toxoid \[PT\].|GMC ratio|1.017|||||TWO_SIDED|97.5|0.918|1.127|||Non-inferiority analysis|||Non-inferiority GMC ratio anti-PT||1.127|0.918|
70855379|NCT02880956|141198388|SUPERIORITY||LS Mean of Difference|1.81|STANDARD_ERROR_OF_MEAN|2.843||0.525|TWO_SIDED|95.0|-3.784|7.404||The statistical model: UPSA-Brief change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||7.404|-3.784|0.525
71081765|NCT01000974|141670796|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to filamentous hemagglutinin \[FHA\].|GMC ratio|1.088|||||TWO_SIDED|97.5|0.983|1.204|||Non-inferiority analysis|||Non-inferiority GMC ratio anti-FHA||1.204|0.983|
70855380|NCT02880956|141198388|OTHER||Effect size/pooled SD|0.1|STANDARD_ERROR_OF_MEAN|18.47|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855381|NCT02880956|141198388|SUPERIORITY||LS Mean of Difference|-1.49|STANDARD_ERROR_OF_MEAN|2.921||0.61|TWO_SIDED|95.0|-7.239|4.255||The statistical model: UPSA-Brief change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||4.255|-7.239|0.610
70855382|NCT02880956|141198388|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|19.53|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855383|NCT02880956|141198389|SUPERIORITY||LS Mean of Difference|-0.79|STANDARD_ERROR_OF_MEAN|1.02||0.438|TWO_SIDED|95.0|-2.798|1.214||The statistical model: ADCS-MCI-ADL-24 change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; var-covar structure = Unstructured.|repeated measures model|||Week 48||1.214|-2.798|0.438
71081766|NCT01000974|141670796|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to pertactin \[PRN\]|GMC ratio|1.193|||||TWO_SIDED|97.5|1.03|1.382|||Non-inferiority analysis|||Non-inferiority GMC ratio anti-PRN||1.382|1.03|
70855384|NCT02880956|141198389|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|7.87|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70954283|NCT00688870|141411082|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Fever \>39 but \<=40 degrees C, Fisher exact test was used to calculate p-value.||||>0.99
71081767|NCT01000974|141670797|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs|GMC ratio|1.006|||||TWO_SIDED|97.5|0.873|1.159|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 1 concentrations||1.159|0.873|
71121070|NCT01340937|141748069|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot C)|-0.16|||||TWO_SIDED|95.0|-0.9|0.47|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.47|-0.90|
71121071|NCT01340937|141748069|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot B - Lot C)|0.0|||||TWO_SIDED|95.0|-0.63|0.62|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.62|-0.63|
71121072|NCT01340937|141748069|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (Comb - Ctrl)|1.28|||<|0.001|TWO_SIDED|95.0|0.46|3.33|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||3.33|0.46|<0.001
71121073|NCT01340937|141748070|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|1.73|||||TWO_SIDED|95.0|0.37|3.4|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||3.40|0.37|
71121074|NCT01340937|141748070|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|0.36|||||TWO_SIDED|95.0|-0.77|1.63|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||1.63|-0.77|
71121075|NCT01340937|141748070|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-1.36|||||TWO_SIDED|95.0|-3.03|0.15|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.15|-3.03|
71121076|NCT01340937|141748070|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|0.72|||<|0.001|TWO_SIDED|95.0|-0.59|3.14|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||3.14|-0.59|<0.001
71121077|NCT01340937|141748071|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|-1.35|||||TWO_SIDED|95.0|-5.17|2.47|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||2.47|-5.17|
71121078|NCT01340937|141748071|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|-3.06|||||TWO_SIDED|95.0|-6.79|0.67|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.67|-6.79|
71121079|NCT01340937|141748071|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-1.71|||||TWO_SIDED|95.0|-5.37|1.94|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||1.94|-5.37|
70944166|NCT01649297|141388210|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.5|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-34.2|-20.9|||ANCOVA|ANCOVA:'Treatment','geographical region','renal function'(screening(eGFR)\[MDRD\]value)-fixed effects and 'baseline HbA1c',baseline FPG-linear covariate||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing FPG after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided)||-20.9|-34.2|<0.0001
71081768|NCT01000974|141670797|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.048|||||TWO_SIDED|97.5|0.921|1.192|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 3 concentrations||1.192|0.921|
71081769|NCT01000974|141670797|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.001|||||TWO_SIDED|97.5|0.886|1.13|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 4 concentrations||1.13|0.886|
71081770|NCT01000974|141670797|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.02|||||TWO_SIDED|97.5|0.874|1.19|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 5 concentrations||1.19|0.874|
71081771|NCT01000974|141670797|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs|GMC ratio|1.031|||||TWO_SIDED|97.5|0.894|1.188|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 6A concentrations||1.188|0.894|
71081772|NCT01000974|141670797|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs|GMC ratio|1.072|||||TWO_SIDED|97.5|0.871|1.32|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 6B concentrations||1.32|0.871|
71081773|NCT01000974|141670797|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.098|||||TWO_SIDED|97.5|0.964|1.251|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 7F concentrations||1.251|0.964|
71081774|NCT01000974|141670797|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.035|||||TWO_SIDED|97.5|0.89|1.204|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 9V concentrations||1.204|0.89|
70954284|NCT00688870|141411082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.522||95.0|||||Fisher Exact|||For Decreased appetite, Fisher exact test was used to calculate p-value.||||0.522
71081775|NCT01000974|141670797|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.096|||||TWO_SIDED|97.5|0.929|1.294|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 14 concentrations||1.294|0.929|
71081776|NCT01000974|141670797|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.042|||||TWO_SIDED|97.5|0.9|1.207|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 18C concentrations||1.207|0.9|
71081777|NCT01000974|141670797|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.001|||||TWO_SIDED|97.5|0.859|1.167|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 19A concentrations||1.167|0.859|
70954285|NCT00688870|141411082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.872||95.0|||||Fisher Exact|||For Irritability, Fisher exact test was used to calculate p-value.||||0.872
71081778|NCT01000974|141670797|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|0.969|||||TWO_SIDED|97.5|0.855|1.098|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 19F concentrations||1.098|0.855|
71081779|NCT01000974|141670797|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.031|||||TWO_SIDED|97.5|0.862|1.232|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 23F concentrations||1.232|0.862|
71081780|NCT01000974|141670798|OTHER|To rule out 10% decrease in seroresponse to FHA in subjects receiving DTPa-HBV-IPV coadministered with Test Hib,13Pn \& HRV vaccines compared to subjects receiving DTPa-HBV-IPV co-administered with Control Hib, 13Pn \&HRV vaccines,following 3 primary vaccine doses where seroresponse wasdefined as percentage of subjects showing aconcentration above a threshold that led to 95% seroresponse in control|||||<|0.0001|||||||t-test, 1 sided|P-value is computed by integrating on the p-values of one-sided test with alpha=0.025 \& the posterior probability of the cut-off in the control group||Difference in seroresponse Anti-FHA||||<0.0001
71121080|NCT01340937|141748071|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|-4.7|||<|0.001|TWO_SIDED|95.0|-7.73|-0.86|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||-0.86|-7.73|<0.001
71081781|NCT01000974|141670798|OTHER|To rule out 10% decrease in seroresponse to PT in subjects receiving DTPa-HBV-IPV coadministered with Test Hib,13Pn \& HRV vaccines compared to subjects receiving DTPa-HBV-IPV co-administered with Control Hib, 13Pn \&HRV vaccines,following 3 primary vaccine doses where seroresponse wasdefined as percentage of subjects showing aconcentration above a threshold that led to 95% seroresponse in control|||||<|0.0001||||||P-value is computed by integrating on the p-values of one-sided test with alpha=0.025 and the posterior probability of the cut-off in the control group|t-test, 1 sided|||Difference in seroresponse Anti-PT||||<0.0001
70954286|NCT00688870|141411082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.868||95.0|||||Fisher Exact|||For Increased sleep, Fisher exact test was used to calculate p-value.||||0.868
71081782|NCT01000974|141670798|OTHER|To rule out 10% decrease in seroresponse to PRN in subjects receiving DTPa-HBV-IPV coadministered with Test Hib,13Pn \& HRV vaccines compared to subjects receiving DTPa-HBV-IPV co-administered with Control Hib, 13Pn \&HRV vaccines,following 3 primary vaccine doses where seroresponse wasdefined as percentage of subjects showing aconcentration above a threshold that led to 95% seroresponse in control|||||<|0.0001||||||P-value is computed by integrating on the p-values of one-sided test with alpha=0.025 and the posterior probability of the cut-off in the control group|t-test, 1 sided|||Difference in seroresponse Anti-PRN||||<0.0001
71081783|NCT01000974|141670799|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to poliovirus 1.|Difference in percentage|-0.67|||||TWO_SIDED|97.5|-2.24|0.87|||Non-inferiority analysis|||Non-inferiority Anti-Polio 1 concentrations||0.87|-2.24|
71081784|NCT01000974|141670799|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to poliovirus 2.|Difference in percentage|0.45|||||TWO_SIDED|97.5|-1.45|2.91|||Non-inferiority analysis|||Non-inferiority Anti-Polio 2 concentration||2.91|-1.45|
71081785|NCT01000974|141670799|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to poliovirus 3.|Difference in percentage|-0.66|||||TWO_SIDED|97.5|-2.2|0.88|||Non-inferiority analysis|||Non-inferiority Anti-Polio 3 concentration||0.88|-2.2|
71081786|NCT02872909|141670841|SUPERIORITY||Mean Difference (Final Values)|1.37|||<|0.05|TWO_SIDED|95.0|0.71|2.54||calculated as \<0.05 for 85% power|t-test, 2 sided|Analysed on log transformed data||Sample size requirement estimation - Preliminary data showed pain scores of 1.25 with ambulatory PDT (n=12) and 5.26 (SD 2.38) for conventional PDT (n=50). Estimated that for 85% power to detect as significant at 5% level a difference in mean pain score in one group of 2cm compared with 4 cm in the other group, assuming two-sided testing, a minimum of 45 subjects needed. We aimed for 50 subjects, with an allocation ratio of 2 (twice as many randomised to ambulatory PDT as conventional PDT)||2.54|0.71|<0.05
71081787|NCT02872909|141670844|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71121081|NCT01340937|141748072|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|2.77|||||TWO_SIDED|95.0|-1.83|7.39|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||7.39|-1.83|
71121082|NCT01340937|141748072|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|2.41|||||TWO_SIDED|95.0|-2.21|7.06|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||7.06|-2.21|
71121083|NCT01340937|141748072|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-0.36|||||TWO_SIDED|95.0|-5.14|4.42|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||4.42|-5.14|
71121084|NCT01340937|141748072|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|3.28|||<|0.001|TWO_SIDED|95.0|-1.7|8.85|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||8.85|-1.70|<0.001
71121085|NCT01340937|141748073|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|-4.12|||||TWO_SIDED|95.0|-7.69|-0.63|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||-0.63|-7.69|
71121086|NCT01340937|141748073|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|-4.17|||||TWO_SIDED|95.0|-7.75|-0.66|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||-0.66|-7.75|
71121087|NCT01340937|141748073|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-0.07|||||TWO_SIDED|95.0|-3.32|3.2|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||3.20|-3.32|
71121088|NCT01340937|141748073|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|2.85|||<|0.001|TWO_SIDED|95.0|-0.85|7.36|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||7.36|-0.85|<0.001
71081788|NCT00809094|141670848|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21||||0.14|TWO_SIDED|95.0|-0.07|0.48|||t-test, 2 sided|||Null hypothesis: there will be no difference in the change in human neutrophil activity measured from baseline to end of the study (24 weeks)||0.48|-0.07|0.14
70855385|NCT02880956|141198389|SUPERIORITY||LS Mean of Difference|0.81|STANDARD_ERROR_OF_MEAN|1.005||0.419|TWO_SIDED|95.0|-1.164|2.788||The statistical model: ADCS-MCI-ADL-24 change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; var-covar structure = Unstructured.|repeated measures model|||Week 48||2.788|-1.164|0.419
70855386|NCT02880956|141198389|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|7.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855387|NCT02880956|141198389|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|1.03||0.948|TWO_SIDED|95.0|-1.959|2.092||The statistical model: ADCS-MCI-ADL-24 change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; var-covar structure = Unstructured.|repeated measures model|||Week 48||2.092|-1.959|0.948
70855388|NCT02880956|141198389|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|8.01|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855389|NCT02880956|141198389|SUPERIORITY||LS Mean of Difference|-1.04|STANDARD_ERROR_OF_MEAN|1.597||0.516|TWO_SIDED|95.0|-4.18|2.101||The statistical model: ADCS-MCI-ADL-24 change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; var-covar structure = Unstructured.|repeated measures model|||Week 96||2.101|-4.180|0.516
70855390|NCT02880956|141198389|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|10.87|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855391|NCT02880956|141198389|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|1.582||0.971|TWO_SIDED|95.0|-3.055|3.168||The statistical model: ADCS-MCI-ADL-24 change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; var-covar structure = Unstructured.|repeated measures model|||Week 96||3.168|-3.055|0.971
70855392|NCT02880956|141198389|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|11.24|||TWO_SIDED|||||||||Week 96||||
70855393|NCT02880956|141198389|SUPERIORITY||LS Mean of Difference|-1.39|STANDARD_ERROR_OF_MEAN|1.621||0.392|TWO_SIDED|95.0|-4.577|1.8||The statistical model: ADCS-MCI-ADL-24 change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; var-covar structure = Unstructured.|repeated measures model|||Week 96||1.800|-4.577|0.392
70855394|NCT02880956|141198389|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|10.87|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855395|NCT02880956|141198390|SUPERIORITY||LS Mean of Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.902||0.148|TWO_SIDED|95.0|-3.08|0.465||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.465|-3.080|0.148
70855396|NCT02880956|141198390|SUPERIORITY||Effect size/pooled SD|-0.19|STANDARD_DEVIATION|6.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70954287|NCT00688870|141411082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.237||95.0|||||Fisher Exact|||For Decreased sleep, Fisher exact test was used to calculate p-value.||||0.237
71081789|NCT00397189|141670861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.6|STANDARD_DEVIATION|47.0|<|0.05|TWO_SIDED|95.0|-25.3|-6.0|||ANCOVA|||The analysis was a comparison of sleep latency as measured by the sleep diary at Visit 3 in the ITT 65-80 population, using a linear regression model with terms for treatment (Circadin® 2mg vs. Placebo) and baseline sleep latency.||-6|-25.3|<0.05
71081790|NCT02620683|141670863|OTHER||Median Difference (Final Values)|-15.0||||0.006|TWO_SIDED|95.0|-34.6|-5.86|||Wilcoxon (Mann-Whitney)||for a cross over design difference in blood level was calculate buffered lidocaine minus non-buffered lidocaine|The difference between injection type- 95% confidence intervals for the difference between injection types was calculated. For the outcome variable, an assessment of treatment difference by subject, calculated as 1% Buffered minus 2% Non-Buffered, was performed using Wilcoxon signed rank tests (SAS v 9.3). Statistical significance was set as P \< 0.05 for all outcomes.||-5.86|-34.6|0.006
71121089|NCT01340937|141748074|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot B)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
71121090|NCT01340937|141748074|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot C)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
71081791|NCT02620683|141670864|OTHER||Mean Difference (Final Values)|-0.66||||0.096|TWO_SIDED|95.0|-1.46|0.13|||t-test, 2 sided|||The difference between injection type- 95% confidence intervals for the difference between injection types was calculated. For the outcome variable, an assessment of treatment difference by subject, calculated as 1% Buffered minus 2% Non-Buffered, was performed using ProcTTEST (SAS v 9.3). Statistical significance was set as P \< 0.05 for all outcomes.||0.13|-1.46|0.096
71081792|NCT02620683|141670865|OTHER||Median Difference (Final Values)|-1.0||||0.23|TWO_SIDED|95.0|-4.0|1.0|||Wilcoxon (Mann-Whitney)|||The difference between injection type- 95% confidence intervals for the difference between injection types was calculated. For the outcome variable, an assessment of treatment difference by subject, calculated as 1% Buffered minus 2% Non-Buffered, was performed using Wilcoxon signed rank tests (SAS v 9.3). Statistical significance was set as P \< 0.05 for all outcomes.||1|-4|0.23
71081793|NCT01535443|141670867|OTHER|||||||0.374|||||||Traza Pillai|The test was performed with degrees of freedom: 2||||||.374
71121091|NCT01340937|141748074|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot B - Lot C)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
71081794|NCT01029262|141670892|SUPERIORITY||Risk Ratio (RR)|10.616|||<|0.001|TWO_SIDED|95.0|2.639|42.702|||Fisher Exact|p-value is from Fisher's exact test to compare lenalidomide treatment group to placebo group||||42.702|2.639|<0.001
71081795|NCT01029262|141670893|SUPERIORITY|||||||1|||||||Fisher Exact|p-value is from Fisher's exact test to compare lenalidomide treatment group to placebo group.||||||1.000
71081796|NCT01029262|141670894|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.0|||<|0.001|TWO_SIDED|95.0|0.0||NA for risk ratio is due to 0 responder in placebo group.|P-value is from Fisher's exact test to compare the lenalidomide arm to the placebo arm.|Fisher Exact||||||0|< 0.001
71081797|NCT01029262|141670895|SUPERIORITY|||||||0.639|TWO_SIDED||||||Log Rank|p-value from log-rank test to compare lenalidomide and placebo.||||||0.639
71081798|NCT01029262|141670896|SUPERIORITY||Risk Ratio (RR)|1.276||||0.252|TWO_SIDED|95.0|0.867|1.877||p-value is from Fisher's exact test to compare the lenalidomide arm to the placebo arm.|Fisher Exact|||||1.877|0.867|0.252
71081799|NCT01029262|141670898|SUPERIORITY|||||||0.864|TWO_SIDED|||||p-value from log-rank test to compare lenalidomide and placebo.|Log Rank|||||||0.864
71081800|NCT01029262|141670899|SUPERIORITY|||||||0.98||||||p-value from log-rank test to compare lenalidomide and placebo.|Log Rank|||||||0.980
71081801|NCT01029262|141670901|SUPERIORITY|||||||0.823|TWO_SIDED||||||Fisher Exact|The p-values are calculated based on the Fisher exact test||Baseline||||0.823
71081802|NCT01029262|141670901|SUPERIORITY|||||||0.371|TWO_SIDED||||||Fisher Exact|The p-values are calculated based on the Fisher exact test||Week 12 (±3 days)||||0.371
71121092|NCT01340937|141748074|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (Comb - Ctrl)|0.66|||<|0.001|TWO_SIDED|95.0|0.18|2.36|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||2.36|0.18|<0.001
71121093|NCT01340937|141748075|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot B)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
71121094|NCT01340937|141748075|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot C)|0.0|||||TWO_SIDED|95.0|-0.61|0.6|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.60|-0.61|
71121095|NCT01340937|141748075|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot B - Lot C)|0.0|||||TWO_SIDED|95.0|-0.61|0.6|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.60|-0.61|
71121096|NCT01340937|141748075|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (Comb - Ctrl)|0.0|||<|0.001|TWO_SIDED|95.0|-0.2|1.24|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||1.24|-0.20|<0.001
71121097|NCT01340937|141748076|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot B)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
71121098|NCT01340937|141748076|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot C)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
71121099|NCT01340937|141748076|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot B - Lot C)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
71121100|NCT01340937|141748076|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (Comb - Ctrl)|0.33|||<|0.001|TWO_SIDED|95.0|0.05|1.85|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||1.85|0.05|<0.001
71121101|NCT01340937|141748077|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.07|||<|0.001|TWO_SIDED|95.0|0.98|1.17|||Analysis of Covariance|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.17|0.98|<0.001
71081803|NCT01029262|141670901|SUPERIORITY|||||||0.391|TWO_SIDED||||||Fisher Exact|The p-values are calculated based on the Fisher exact test||Week 24 (±3 days)||||0.391
71081804|NCT01029262|141670901|SUPERIORITY|||||||1|TWO_SIDED||||||Fisher Exact|The p-values are calculated based on the Fisher exact test||Week 36 (±3 days)||||1.000
71081805|NCT01029262|141670901|SUPERIORITY|||||||0.508|TWO_SIDED||||||Fisher Exact|The p-values are calculated based on the Fisher exact test||Week 48 (±3 days)||||0.508
71081806|NCT01029262|141670902|SUPERIORITY|||||||0.323|TWO_SIDED||||||ANOVA|P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.||Week 12||||0.323
71081807|NCT01029262|141670902|SUPERIORITY|||||||0.071|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 24||||0.071
71081808|NCT01029262|141670903|SUPERIORITY|||||||0.76|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score|ANOVA|||Week 12||||0.760
71081809|NCT01029262|141670903|SUPERIORITY|||||||0.251|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 24||||0.251
70855397|NCT02880956|141198390|SUPERIORITY||LS Mean of Difference|-1.52|STANDARD_ERROR_OF_MEAN|0.896||0.092|TWO_SIDED|95.0|-3.278|0.246||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.246|-3.278|0.092
71081810|NCT01029262|141670904|SUPERIORITY|||||||0.424|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 12||||0.424
71081811|NCT01029262|141670904|SUPERIORITY|||||||0.116|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 24||||0.116
71081812|NCT01029262|141670905|SUPERIORITY|||||||0.746|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 12||||0.746
71081813|NCT01029262|141670905|SUPERIORITY|||||||0.46|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||||||0.460
71081814|NCT01029262|141670906|SUPERIORITY|||||||0.265|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 12||||0.265
71081815|NCT01029262|141670906|SUPERIORITY|||||||0.047|TWO_SIDED|||||3\]: P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 24||||0.047
71081816|NCT01029262|141670907|SUPERIORITY|||||||0.2909|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments.|t-test, 2 sided|||Week 12||||0.2909
71081817|NCT01029262|141670907|SUPERIORITY|||||||0.0759|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments.|t-test, 2 sided|||Week 24||||0.0759
71081818|NCT01029262|141670908|SUPERIORITY|||||||0.6957|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments|t-test, 2 sided|||Week 12||||0.6957
71081819|NCT01029262|141670908|SUPERIORITY|||||||0.1729|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments|t-test, 2 sided|||Week 24||||0.1729
71081820|NCT01029262|141670909|SUPERIORITY|||||||0.3975|TWO_SIDED||||||t-test, 2 sided|P-value is based on a two-sample t-test comparing the difference between treatments.||Week 12||||0.3975
71081821|NCT01029262|141670909|SUPERIORITY|||||||0.1714|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments.|t-test, 2 sided|||Week 24||||0.1714
71081822|NCT01029262|141670910|SUPERIORITY|||||||0.6408|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments.|t-test, 2 sided|||Week 12||||0.6408
71081823|NCT01029262|141670910|SUPERIORITY|||||||0.575|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments.|t-test, 2 sided|||Week 24||||0.5750
71081824|NCT01029262|141670911|SUPERIORITY|||||||0.2848|TWO_SIDED||||||t-test, 2 sided|P-value is based on a two-sample t-test comparing the difference between treatments||Week 12||||0.2848
71081825|NCT01029262|141670911|SUPERIORITY|||||||0.1053|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments|t-test, 1 sided|||Week 24||||0.1053
71081826|NCT01029262|141670912|SUPERIORITY|||||||0.042|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 12||||0.042
71081827|NCT01029262|141670912|SUPERIORITY|||||||0.448|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 24||||0.448
71081828|NCT01029262|141670913|SUPERIORITY|||||||0.825|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 12||||0.825
71081829|NCT01029262|141670913|SUPERIORITY|||||||0.568|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 24||||0.568
71081830|NCT01029262|141670914|SUPERIORITY|||||||0.119|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 12||||0.119
70944167|NCT01649297|141388210|SUPERIORITY_OR_OTHER||Adjusted mean difference|-22.5|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-29.2|-15.9|||ANCOVA|ANCOVA:'Treatment','geographical region','renal function'(screening(eGFR)\[MDRD\]value)-fixed effects and 'baseline HbA1c',baseline FPG-linear covariate||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing FPG after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided)||-15.9|-29.2|<0.0001
70944168|NCT01649297|141388210|SUPERIORITY_OR_OTHER||Adjusted mean difference|-21.1|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-27.7|-14.4|||ANCOVA|ANCOVA:'Treatment','geographical region','renal function'(screening(eGFR)\[MDRD\]value)-fixed effects and 'baseline HbA1c',baseline FPG-linear covariate||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing FPG after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided)||-14.4|-27.7|<0.0001
70944169|NCT01649297|141388210|SUPERIORITY_OR_OTHER||Adjusted mean difference|-17.5|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-24.1|-10.8|||ANCOVA|ANCOVA:'Treatment','geographical region','renal function'(screening(eGFR)\[MDRD\]value)-fixed effects and 'baseline HbA1c',baseline FPG-linear covariate||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing FPG after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided)||-10.8|-24.1|<0.0001
70944170|NCT01685047|141388211|OTHER|There were no formal pre-specified statistical hypotheses for the endpoints of the study due to the exploratory nature of this study. Datasets (Device info at Baseline versus 15 minutes prior to the event) were compared using a 2-sided t-test.|||||<|0.05||||||All events with p \<0.05 were visually inspected to confirm they were evaluable; additional criteria for exclusion from further analysis included inappropriate therapy, aberrant conduction, and occurrence of VT/VF within 24h prior to the event.|t-test, 2 sided|||There were no formal pre-specified statistical hypotheses for the endpoints of the study due to the exploratory nature of this study. Some data was excluded from the primary analysis. All device detections resulting in therapy have been reviewed for appropriateness of the therapy. VT/VF therapy delivered from the device as a result of a non-ventricular arrhythmia or as a result of oversensing by the device has not been included in the primary data analysis.||||<0.05
71081831|NCT01029262|141670914|SUPERIORITY|||||||0.172|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 24||||0.172
71081832|NCT01029262|141670915|SUPERIORITY|||||||0.792|TWO_SIDED|||||The P-values were calculated based on Fisher exact test.|Fisher Exact|||Week 12||||0.792
71081833|NCT01029262|141670915|SUPERIORITY|||||||0.279|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 24||||0.279
70944171|NCT00451555|141388229|SUPERIORITY|||||||0.6238|||||||Fisher Exact|||||||0.6238
71081834|NCT01029262|141670916|SUPERIORITY|||||||0.476|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 12||||0.476
71081835|NCT01029262|141670916|SUPERIORITY|||||||0.052|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 24||||0.052
70855398|NCT02880956|141198390|SUPERIORITY||Effect size/pooled SD|-0.21|STANDARD_DEVIATION|7.14|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71081836|NCT01029262|141670917|SUPERIORITY||Risk Ratio (RR)|1.759||||0.017|TWO_SIDED|95.0|1.083|2.856||p-value is from Fisher's exact test to compare lenalidomide treatment group to placebo group.|Fisher Exact|||||2.856|1.083|0.017
71081837|NCT03410992|141670921|SUPERIORITY||Odds Ratio (OR)|496.318|||<|0.001|TWO_SIDED|95.0|82.798|2975.086||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||2975.086|82.798|<0.001
71081838|NCT03410992|141670922|SUPERIORITY||Odds Ratio (OR)|657.255|||<|0.001|TWO_SIDED|95.0|105.792|4083.333||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||4083.333|105.792|<0.001
70944172|NCT00451555|141388229|SUPERIORITY|||||||0.6282|||||||Fisher Exact|||||||0.6282
70944173|NCT00451555|141388229|SUPERIORITY|||||||0.6242|||||||Fisher Exact|||||||0.6242
70944174|NCT00451555|141388230|SUPERIORITY|||||||0.639|||||||Fisher Exact|||||||0.6390
70944175|NCT00451555|141388230|SUPERIORITY|||||||0.6721|||||||Fisher Exact|||||||0.6721
70944176|NCT00451555|141388230|SUPERIORITY|||||||0.6349|||||||Fisher Exact|||||||0.6349
70944177|NCT00451555|141388231|SUPERIORITY|||||||0.8582|||||||Log Rank|||||||0.8582
70944178|NCT00451555|141388231|SUPERIORITY|||||||0.7307|||||||Log Rank|||||||0.7307
71081839|NCT03410992|141670923|SUPERIORITY||Odds Ratio (OR)|220.038|||<|0.001|TWO_SIDED|95.0|28.757|1683.639||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||1683.639|28.757|<0.001
71081840|NCT03410992|141670924|SUPERIORITY||Odds Ratio (OR)|224.744|||<|0.001|TWO_SIDED|95.0|30.13|1676.425||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||1676.425|30.130|<0.001
70944179|NCT00451555|141388231|SUPERIORITY|||||||0.9798|||||||Log Rank|||||||0.9798
70944180|NCT00451555|141388232|SUPERIORITY|||||||0.5887|||||||Log Rank|||||||0.5887
70944181|NCT00451555|141388232|SUPERIORITY|||||||0.4516|||||||Log Rank|||||||0.4516
70944182|NCT00451555|141388232|SUPERIORITY|||||||0.7965|||||||Log Rank|||||||0.7965
70855399|NCT02880956|141198390|SUPERIORITY||LS Mean of Difference|-1.65|STANDARD_ERROR_OF_MEAN|0.915||0.073|TWO_SIDED|95.0|-3.446|0.152||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.152|-3.446|0.073
70944183|NCT02847637|141388235|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.02|0.075||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value was obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm A is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm A versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm A versus Arm C ≠ 1.||0.075|0.020|<0.0001
70944184|NCT02847637|141388235|SUPERIORITY||ABR Ratio|0.03|||<|0.0001|TWO_SIDED|95.0|0.017|0.066||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value was obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm B is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm B versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm B versus Arm C ≠ 1.||0.066|0.017|<0.0001
70944185|NCT02847637|141388236|SUPERIORITY||ABR Ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.028|0.099||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value was obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm A is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm A versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm A versus Arm C ≠ 1.||0.099|0.028|<0.0001
70944186|NCT02847637|141388236|SUPERIORITY||ABR Ratio|0.06|||<|0.0001|TWO_SIDED|95.0|0.03|0.103||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value was obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm B is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm B versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm B versus Arm C ≠ 1.||0.103|0.030|<0.0001
70944187|NCT02847637|141388237|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.019|0.085||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value is obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm A is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm A versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm A versus Arm C ≠ 1.||0.085|0.019|<0.0001
70944188|NCT02847637|141388237|SUPERIORITY||ABR Ratio|0.03|||<|0.0001|TWO_SIDED|95.0|0.015|0.07||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value is obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm B is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm B versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm B versus Arm C ≠ 1.||0.070|0.015|<0.0001
70954288|NCT00688870|141411083|SUPERIORITY_OR_OTHER_LEGACY|||||||0.329||95.0|||||Fisher Exact|||For Fever \>=38 but \<=39 degrees C, Fisher exact test was used to calculate p-value.||||0.329
70954289|NCT00688870|141411083|SUPERIORITY_OR_OTHER_LEGACY|||||||0.492||95.0|||||Fisher Exact|||For Fever \>39 but \<=40 degrees C, Fisher exact test was used to calculate p-value.||||0.492
71081841|NCT03410992|141670925|SUPERIORITY||Odds Ratio (OR)|316.641|||<|0.001|TWO_SIDED|95.0|39.423|2543.254||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||2543.254|39.423|<0.001
71081842|NCT03410992|141670926|SUPERIORITY||Odds Ratio (OR)|34.325|||<|0.001|TWO_SIDED|95.0|14.22|82.856||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||82.856|14.220|<0.001
70855400|NCT02880956|141198390|SUPERIORITY||Effect size/pooled SD|-0.25|STANDARD_DEVIATION|6.55|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855401|NCT02880956|141198390|SUPERIORITY||LS Mean of Difference|0.47|STANDARD_ERROR_OF_MEAN|1.081||0.662|TWO_SIDED|95.0|-1.652|2.599||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.599|-1.652|0.662
70855402|NCT02880956|141198390|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|8.07|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71081843|NCT03410992|141670927|SUPERIORITY||Odds Ratio (OR)|43.497|||<|0.001|TWO_SIDED|95.0|15.728|120.295||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||120.295|15.728|<0.001
70855403|NCT02880956|141198390|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|1.057||0.992|TWO_SIDED|95.0|-2.089|2.068||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.068|-2.089|0.992
71081844|NCT03410992|141670928|SUPERIORITY||Odds Ratio (OR)|60.946|||<|0.001|TWO_SIDED|95.0|20.56|180.669||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haensze (CMH) test with region and prior biologic exposure as stratification variables.||180.669|20.560|<0.001
71081845|NCT03410992|141670929|SUPERIORITY||Odds Ratio (OR)|158.0|||<|0.001|TWO_SIDED|95.0|49.263|506.745||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||506.745|49.263|<0.001
71081846|NCT03410992|141670930|SUPERIORITY||Odds Ratio (OR)|45.192|||<|0.001|TWO_SIDED|95.0|18.622|109.672||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables. This statistical analysis is not controlled for multiplicity and is only nominal.||109.672|18.622|<0.001
71081847|NCT03410992|141670930|SUPERIORITY||Odds Ratio (OR)|49.297|||<|0.001|TWO_SIDED|95.0|18.887|128.673||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables. This statistical analysis is not controlled for multiplicity and is only nominal.||128.673|18.887|<0.001
71081848|NCT03410992|141670930|SUPERIORITY||Odds Ratio (OR)|47.406|||<|0.001|TWO_SIDED|95.0|22.087|101.75||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables. This statistical analysis is not controlled for multiplicity and is only nominal.||101.750|22.087|<0.001
71081849|NCT03299101|141670965|SUPERIORITY|||||||0.872|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in grip strength across all 4 time points.||||0.872
71081850|NCT03299101|141670965|SUPERIORITY||Mean Difference (Net)|0.57|STANDARD_ERROR_OF_MEAN|0.71||0.423|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in grip strength between baseline and day of surgery.||||0.423
71081851|NCT03299101|141670965|SUPERIORITY||Mean Difference (Net)|-0.39|STANDARD_ERROR_OF_MEAN|2.12||0.853|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in grip strength between baseline and 90 days postop.||||0.853
71081852|NCT03299101|141670965|SUPERIORITY||Mean Difference (Net)|-1.28|STANDARD_ERROR_OF_MEAN|2.16||0.552|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in grip strength between day of surgery and 90 days postop.||||0.552
71081853|NCT03299101|141670966|SUPERIORITY|||||||0.256||||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in max MIP across all 4 time points.||||0.256
71081854|NCT03299101|141670966|SUPERIORITY||Mean Difference (Net)|4.69|STANDARD_ERROR_OF_MEAN|2.78||0.091|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum MIP between baseline and day of surgery.||||0.091
71081855|NCT03299101|141670966|SUPERIORITY||Mean Difference (Net)|6.8|STANDARD_ERROR_OF_MEAN|3.69||0.066|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum MIP between baseline and 90 days postop.||||0.066
71081856|NCT03299101|141670966|SUPERIORITY||Mean Difference (Net)|1.86|STANDARD_ERROR_OF_MEAN|3.13||0.552|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum MIP between day of surgery and 90 days postop.||||0.552
71081857|NCT03299101|141670967|SUPERIORITY|||||||0.003||||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in mean MIP across all 4 time points.||||0.003
70944189|NCT02847637|141388238|SUPERIORITY||ABR Ratio|0.06|||<|0.0001|TWO_SIDED|95.0|0.025|0.151||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value is obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm A is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm A versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm A versus Arm C ≠ 1.||0.151|0.025|<0.0001
70954290|NCT00688870|141411083|SUPERIORITY_OR_OTHER_LEGACY|||||||0.496||95.0|||||Fisher Exact|||For Fever \>40 degrees C, Fisher exact test was used to calculate p-value.||||0.496
71081858|NCT03299101|141670967|SUPERIORITY||Mean Difference (Net)|7.48|STANDARD_ERROR_OF_MEAN|2.48||0.003|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MIP between baseline and day of surgery.||||0.003
70855404|NCT02880956|141198390|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|8.38|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70954291|NCT00688870|141411083|SUPERIORITY_OR_OTHER_LEGACY|||||||0.322||95.0|||||Fisher Exact|||For Decreased appetite, Fisher exact test was used to calculate p-value.||||0.322
71081859|NCT03299101|141670967|SUPERIORITY||Mean Difference (Net)|10.18|STANDARD_ERROR_OF_MEAN|3.61||0.005|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MIP between baseline and 90 days postop.||||0.005
70855405|NCT02880956|141198390|SUPERIORITY||LS Mean of Difference|-0.82|STANDARD_ERROR_OF_MEAN|1.088||0.451|TWO_SIDED|95.0|-2.961|1.32||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.320|-2.961|0.451
71081860|NCT03299101|141670967|SUPERIORITY||Mean Difference (Net)|2.31|STANDARD_ERROR_OF_MEAN|2.18||0.29|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MIP between day of surgery and 90 days postop.||||0.290
70855406|NCT02880956|141198390|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|7.72|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855407|NCT02880956|141198390|SUPERIORITY||LS Mean of Difference|-0.67|STANDARD_ERROR_OF_MEAN|1.227||0.583|TWO_SIDED|95.0|-3.088|1.739||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.739|-3.088|0.583
70855408|NCT02880956|141198390|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|8.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855409|NCT02880956|141198390|SUPERIORITY||LS Mean of Difference|-1.59|STANDARD_ERROR_OF_MEAN|1.213||0.191|TWO_SIDED|95.0|-3.975|0.795||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.795|-3.975|0.191
70855410|NCT02880956|141198390|SUPERIORITY||Effect size/pooled SD|-0.17|STANDARD_DEVIATION|9.37|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855411|NCT02880956|141198390|SUPERIORITY||LS Mean of Difference|-1.11|STANDARD_ERROR_OF_MEAN|1.238||0.372|TWO_SIDED|95.0|-3.541|1.329|||repeated measures model|||Week 72||1.329|-3.541|0.372
70855412|NCT02880956|141198390|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|8.96|||TWO_SIDED|||||||||Week 72||||
70855413|NCT02880956|141198390|SUPERIORITY||LS Mean of Difference|-0.99|STANDARD_ERROR_OF_MEAN|1.303||0.447|TWO_SIDED|95.0|-3.553|1.571||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.571|-3.553|0.447
70855414|NCT02880956|141198390|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|9.35|||TWO_SIDED|||||||||Week 96||||
70855415|NCT02880956|141198390|SUPERIORITY||LS Mean of Difference|0.19|STANDARD_ERROR_OF_MEAN|1.285||0.881|TWO_SIDED|95.0|-2.334|2.719||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.719|-2.334|0.881
70855416|NCT02880956|141198390|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|8.68|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855417|NCT02880956|141198390|SUPERIORITY||LS Mean of Difference|-0.25|STANDARD_ERROR_OF_MEAN|1.338||0.853|TWO_SIDED|95.0|-2.881|2.383||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.383|-2.881|0.853
70855418|NCT02880956|141198390|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|8.54|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855419|NCT02880956|141198391|SUPERIORITY||LS Mean of Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.846||0.287|TWO_SIDED|95.0|-2.567|0.762||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.762|-2.567|0.287
70855420|NCT02880956|141198391|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|6.76|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855421|NCT02880956|141198391|SUPERIORITY||LS Mean of Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.838||0.227|TWO_SIDED|95.0|-2.661|0.633||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.633|-2.661|0.227
70855422|NCT02880956|141198391|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|6.83|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70944190|NCT02847637|141388238|SUPERIORITY||ABR Ratio|0.02|||<|0.0001|TWO_SIDED|95.0|0.006|0.056||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value is obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm B is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm B versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm B versus Arm C ≠ 1.||0.056|0.006|<0.0001
70855423|NCT02880956|141198391|SUPERIORITY||LS Mean of Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.859||0.241|TWO_SIDED|95.0|-2.698|0.681||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.681|-2.698|0.241
70855424|NCT02880956|141198391|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|6.22|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70954292|NCT00688870|141411083|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61||95.0|||||Fisher Exact|||For Irritability, Fisher exact test was used to calculate p-value.||||0.610
70944191|NCT02847637|141388239|SUPERIORITY||ABR Ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.016|0.143||Not controlled for type I error|Stratified Wald test||Arm A is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm A versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm A versus Arm C ≠ 1.||0.143|0.016|<0.0001
70944192|NCT02847637|141388239|SUPERIORITY||ABR Ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.018|0.147||Not controlled for type I error|Stratified Wald test||Arm B is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm B versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm B versus Arm C ≠ 1.||0.147|0.018|<0.0001
71081861|NCT03299101|141670968|SUPERIORITY|||||||0.009||||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in maximal inspiratory pressure across all 4 time points.||||0.009
71081862|NCT03299101|141670968|SUPERIORITY||Mean Difference (Net)|12.61|STANDARD_ERROR_OF_MEAN|4.57||0.006|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum MEP between baseline and day of surgery.||||0.006
71081863|NCT03299101|141670968|SUPERIORITY||Mean Difference (Net)|12.79|STANDARD_ERROR_OF_MEAN|5.25||0.015|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum MEP between baseline and 90 days postop.||||0.015
71081864|NCT03299101|141670968|SUPERIORITY||Mean Difference (Net)|-0.86|STANDARD_ERROR_OF_MEAN|3.42||0.802|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum MEP between day of surgery and 90 days postop.||||0.802
71081865|NCT03299101|141670969|SUPERIORITY|||||||0.01||||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in Mean MEP across all 4 time points.||||0.010
71081866|NCT03299101|141670969|SUPERIORITY||Mean Difference (Net)|12.37|STANDARD_ERROR_OF_MEAN|4.35||0.004|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MEP between baseline and day of surgery.||||0.004
71081867|NCT03299101|141670969|SUPERIORITY||Mean Difference (Net)|9.95|STANDARD_ERROR_OF_MEAN|4.9||0.042|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MEP between baseline and 90 days postop.||||0.042
71081868|NCT03299101|141670969|SUPERIORITY||Mean Difference (Net)|-3.77|STANDARD_ERROR_OF_MEAN|3.08||0.221|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MEP between day of surgery and 90 days postop.||||0.221
71081869|NCT03299101|141670970|SUPERIORITY|||||||0.814|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in max SMIP across all 4 time points.||||0.814
71081870|NCT03299101|141670970|SUPERIORITY||Mean Difference (Net)|10.5|STANDARD_ERROR_OF_MEAN|30.91||0.734|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum SMIP between baseline and day of surgery.||||0.734
71121102|NCT01340937|141748078|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.86|||<|0.001|TWO_SIDED|95.0|0.79|0.95|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||0.95|0.79|<0.001
71121103|NCT01340937|141748079|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.74||||0.035|TWO_SIDED|95.0|0.66|0.83|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||0.83|0.66|0.035
71081871|NCT03299101|141670970|SUPERIORITY||Mean Difference (Net)|21.07|STANDARD_ERROR_OF_MEAN|22.12||0.341|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum SMIP between baseline and 90 days postop.||||0.341
71081872|NCT03299101|141670970|SUPERIORITY||Mean Difference (Net)|28.55|STANDARD_ERROR_OF_MEAN|37.61||0.448|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum SMIP between day of surgery and 90 days postop.||||0.448
70855425|NCT02880956|141198391|SUPERIORITY||LS Mean of Difference|0.81|STANDARD_ERROR_OF_MEAN|0.958||0.397|TWO_SIDED|95.0|-1.073|2.696||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.696|-1.073|0.397
70954293|NCT00688870|141411083|SUPERIORITY_OR_OTHER_LEGACY|||||||0.726||95.0|||||Fisher Exact|||For Increased sleep, Fisher exact test was used to calculate p-value.||||0.726
71081873|NCT03299101|141670971|SUPERIORITY|||||||0.419|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in mean SMIP across all 4 time points.||||0.419
71081874|NCT03299101|141670971|SUPERIORITY||Mean Difference (Net)|20.91|STANDARD_ERROR_OF_MEAN|27.03||0.439|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean SMIP between baseline and day of surgery.||||0.439
71081875|NCT03299101|141670971|SUPERIORITY||Mean Difference (Net)|47.67|STANDARD_ERROR_OF_MEAN|26.19||0.069|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean SMIP between baseline and 90 days postop.||||0.069
71081876|NCT03299101|141670971|SUPERIORITY||Mean Difference (Net)|37.11|STANDARD_ERROR_OF_MEAN|37.96||0.328|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean SMIP between day of surgery and 90 days postop.||||0.328
71081877|NCT03299101|141670972|SUPERIORITY|||||||0.196|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in serum prealbumin across all 4 time points.||||0.196
70855426|NCT02880956|141198391|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|7.45|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71081878|NCT03299101|141670972|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.19||0.562|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in serum prealbumin between baseline and day of surgery.||||0.562
70855427|NCT02880956|141198391|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.936||0.671|TWO_SIDED|95.0|-2.239|1.443||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.443|-2.239|0.671
70855428|NCT02880956|141198391|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|7.59|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855429|NCT02880956|141198391|SUPERIORITY||LS Mean of Difference|-1.16|STANDARD_ERROR_OF_MEAN|0.964||0.231|TWO_SIDED|95.0|-3.052|0.738||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.738|-3.052|0.231
70855430|NCT02880956|141198391|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|7.25|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855431|NCT02880956|141198391|SUPERIORITY||LS Mean of Difference|2.47|STANDARD_ERROR_OF_MEAN|1.137||0.031|TWO_SIDED|95.0|0.23|4.701||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||4.701|0.230|0.031
71081879|NCT03299101|141670972|SUPERIORITY||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.25||0.087|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in serum prealbumin between baseline and 90 days postop.||||0.087
71081880|NCT03299101|141670972|SUPERIORITY||Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|0.23||0.226|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in serum prealbumin between day of surgery and 90 days postop.||||0.226
71081881|NCT03299101|141670973|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in gait speed across all 4 time points.||||0.001
71081882|NCT03299101|141670973|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.04||0.001|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in gait speed between baseline and day of surgery.||||0.001
71081883|NCT03299101|141670973|SUPERIORITY||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.05||0.001|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests|Linear mixed models estimated within-person change in gait speed between baseline and 90 days postop.||||0.001
71081884|NCT03299101|141670973|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.874|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in gait speed between day of surgery and 90 days postop.||||0.874
71081885|NCT03299101|141670974|SUPERIORITY|||||||0.854|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in SPPB across all 4 time points.||||0.854
71081886|NCT03299101|141670974|SUPERIORITY||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.32||0.298|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in SPPB between baseline and day of surgery.||||0.298
71081887|NCT03299101|141670974|SUPERIORITY||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.31||0.684|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in SPPB between baseline and 90 days postop.||||0.684
71081888|NCT03299101|141670974|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.33||0.485|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in SPPB between day of surgery and 90 days postop.||||0.485
71081889|NCT03299101|141670975|SUPERIORITY|||||||0.067|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in RAI across all 4 time points.||||0.067
70954294|NCT00688870|141411083|SUPERIORITY_OR_OTHER_LEGACY|||||||0.855||95.0|||||Fisher Exact|||For Decreased sleep, Fisher exact test was used to calculate p-value.||||0.855
71081890|NCT03299101|141670975|SUPERIORITY||Mean Difference (Net)|2.07|STANDARD_ERROR_OF_MEAN|1.22||0.089|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in RAI between baseline and day of surgery.||||0.089
71081891|NCT03299101|141670975|SUPERIORITY||Mean Difference (Net)|4.37|STANDARD_ERROR_OF_MEAN|1.6||0.006|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in RAI between baseline and 90 days postop.||||0.006
71121104|NCT01340937|141748080|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.31|||<|0.001|TWO_SIDED|95.0|1.17|1.46|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.46|1.17|<0.001
71121105|NCT01340937|141748081|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|0.12|||<|0.001|TWO_SIDED|95.0|-1.11|2.58|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||2.58|-1.11|<0.001
71121106|NCT01340937|141748082|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|-0.16|||<|0.001|TWO_SIDED|95.0|-2.41|3.22|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||3.22|-2.41|<0.001
71121107|NCT01340937|141748083|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|1.15|||<|0.001|TWO_SIDED|95.0|-2.13|5.47|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||5.47|-2.13|<0.001
71121108|NCT01340937|141748084|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|3.0|||<|0.001|TWO_SIDED|95.0|-0.39|7.4|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||7.40|-0.39|<0.001
71121109|NCT01340937|141748085|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.92|||<|0.001|TWO_SIDED|95.0|0.82|1.04|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 1||1.04|0.82|<0.001
71121110|NCT01340937|141748085|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.95|||<|0.001|TWO_SIDED|95.0|0.84|1.06|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 3||1.06|0.84|<0.001
71121111|NCT01340937|141748085|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.0|||<|0.001|TWO_SIDED|95.0|0.89|1.12|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 4||1.12|0.89|<0.001
71121112|NCT01340937|141748085|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.93|||<|0.001|TWO_SIDED|95.0|0.8|1.07|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 5||1.07|0.80|<0.001
71121113|NCT01340937|141748085|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.87|||<|0.001|TWO_SIDED|95.0|0.77|0.99|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 6A||0.99|0.77|<0.001
70954295|NCT00688870|141411084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.326||95.0|||||Fisher Exact|||For Fever \>=38 but \<=39 degrees C, Fisher exact test was used to calculate p-value.||||0.326
71121114|NCT01340937|141748085|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.79||||0.055|TWO_SIDED|95.0|0.64|0.96|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 6B||0.96|0.64|0.055
71121115|NCT01340937|141748085|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.89|||<|0.001|TWO_SIDED|95.0|0.8|0.99|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 7F||0.99|0.80|<0.001
71121116|NCT01340937|141748085|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.0|||<|0.001|TWO_SIDED|95.0|0.88|1.13|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 9V||1.13|0.88|<0.001
71121117|NCT01340937|141748085|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.95|||<|0.001|TWO_SIDED|95.0|0.82|1.1|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 14||1.10|0.82|<0.001
71121118|NCT01340937|141748085|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.89|||<|0.001|TWO_SIDED|95.0|0.79|1.0|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 18C||1.00|0.79|<0.001
71121119|NCT01340937|141748085|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.91|||<|0.001|TWO_SIDED|95.0|0.8|1.03|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 19A||1.03|0.80|<0.001
71121120|NCT01340937|141748085|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.97|||<|0.001|TWO_SIDED|95.0|0.87|1.08|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 19F||1.08|0.87|<0.001
71121121|NCT01340937|141748085|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.9|||<|0.001|TWO_SIDED|95.0|0.77|1.06|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 23F||1.06|0.77|<0.001
71121122|NCT01340937|141748087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||||TWO_SIDED|95.0|-18.8|-8.4|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, all routes \<38.0°C||-8.4|-18.8|
70855432|NCT02880956|141198391|SUPERIORITY||Effect size/pooled SD|0.29|STANDARD_DEVIATION|8.65|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70944193|NCT02847637|141388240|SUPERIORITY||ABR Ratio|0.32|||<|0.0001|TWO_SIDED|95.0|0.195|0.514||Statistical significance is controlled at the 2-sided, 0.05 alpha level.|Non-stratified Wald test||Dnisp: Emicizumab Prophylaxis is the numerator and Dnisp: Pre-Study FVIII Prophylaxis is the denominator for this ABR ratio.|H0 (null hypothesis): ABR Ratio = 1. H1 (alternative hypothesis): ABR Ratio ≠ 1.||0.514|0.195|<0.0001
70855433|NCT02880956|141198391|SUPERIORITY||LS Mean of Difference|0.68|STANDARD_ERROR_OF_MEAN|1.124||0.547|TWO_SIDED|95.0|-1.532|2.888||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||2.888|-1.532|0.547
70855434|NCT02880956|141198391|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|9.1|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855435|NCT02880956|141198391|SUPERIORITY||LS Mean of Difference|0.73|STANDARD_ERROR_OF_MEAN|1.145||0.524|TWO_SIDED|95.0|-1.521|2.984||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||2.984|-1.521|0.524
70855436|NCT02880956|141198391|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|8.42|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855437|NCT02880956|141198391|SUPERIORITY||LS Mean of Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.356||0.54|TWO_SIDED|95.0|-3.499|1.836||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.836|-3.499|0.540
70855438|NCT02880956|141198391|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|10.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70944194|NCT02847637|141388241|SUPERIORITY||ABR Ratio|0.37||||0.0002|TWO_SIDED|95.0|0.22|0.626||Statistical significance is controlled at the 2-sided, 0.05 alpha level.|Non-stratified Wald test||Dnisp: Emicizumab Prophylaxis is the numerator and Dnisp: Pre-Study FVIII Prophylaxis is the denominator for this ABR ratio.|H0 (null hypothesis): ABR Ratio = 1. H1 (alternative hypothesis): ABR Ratio ≠ 1.||0.626|0.220|0.0002
70855439|NCT02880956|141198391|SUPERIORITY||LS Mean of Difference|-0.58|STANDARD_ERROR_OF_MEAN|1.336||0.664|TWO_SIDED|95.0|-3.208|2.046||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.046|-3.208|0.664
70855440|NCT02880956|141198391|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|10.16|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855441|NCT02880956|141198391|SUPERIORITY||LS Mean of Difference|-1.19|STANDARD_ERROR_OF_MEAN|1.39||0.393|TWO_SIDED|95.0|-3.923|1.546||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.546|-3.923|0.393
70954296|NCT00688870|141411084|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Fever \>39 but \<=40 degrees C, Fisher exact test was used to calculate p-value.||||>0.99
70855442|NCT02880956|141198391|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|9.48|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855443|NCT02880956|141198392|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.262||0.946|TWO_SIDED|95.0|-0.534|0.498||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.498|-0.534|0.946
70855444|NCT02880956|141198392|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|2.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855445|NCT02880956|141198392|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.259||0.242|TWO_SIDED|95.0|-0.813|0.206||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.206|-0.813|0.242
70855446|NCT02880956|141198392|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|2.12|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855447|NCT02880956|141198392|SUPERIORITY||LS Mean of Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.266||0.541|TWO_SIDED|95.0|-0.685|0.36||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.360|-0.685|0.541
70855448|NCT02880956|141198392|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|2.3|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855449|NCT02880956|141198392|SUPERIORITY||LS Mean of Difference|0.11|STANDARD_ERROR_OF_MEAN|0.298||0.724|TWO_SIDED|95.0|-0.481|0.691||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.691|-0.481|0.724
71081892|NCT03299101|141670975|SUPERIORITY||Mean Difference (Net)|1.98|STANDARD_ERROR_OF_MEAN|1.62||0.221|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in RAI between day of surgery and 90 days postop.||||0.221
70855450|NCT02880956|141198392|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|2.36|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855451|NCT02880956|141198392|SUPERIORITY||LS Mean of Difference|0.34|STANDARD_ERROR_OF_MEAN|0.29||0.236|TWO_SIDED|95.0|-0.226|0.913||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.913|-0.226|0.236
70855452|NCT02880956|141198392|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|2.03|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855453|NCT02880956|141198392|SUPERIORITY||LS Mean of Difference|0.11|STANDARD_ERROR_OF_MEAN|0.298||0.714|TWO_SIDED|95.0|-0.477|0.695||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.695|-0.477|0.714
70855454|NCT02880956|141198392|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|2.11|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855455|NCT02880956|141198392|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.277||0.86|TWO_SIDED|95.0|-0.496|0.593||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.593|-0.496|0.860
70855456|NCT02880956|141198392|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|2.08|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71081893|NCT03299101|141670976|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in SGA across all 4 time points.||||0.860
71121123|NCT01340937|141748087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|||||TWO_SIDED|95.0|-0.9|8.3|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, all routes \>=38°C and \<38.5°||8.3|-0.9|
70855457|NCT02880956|141198392|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.274||0.476|TWO_SIDED|95.0|-0.733|0.343||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.343|-0.733|0.476
71081894|NCT03299101|141670976|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.41|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in SGA between baseline and day of surgery.||||0.410
71081895|NCT03299101|141670976|SUPERIORITY||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.17||0.622|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in SGA between baseline and 90 days postop.||||0.622
71121124|NCT01340937|141748087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.7|||||TWO_SIDED|95.0|4.8|11.9|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, all routes \>=38.5°C and \<39.5°||11.9|4.8|
70855458|NCT02880956|141198392|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|2.0|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855459|NCT02880956|141198392|SUPERIORITY||LS Mean of Difference|0.15|STANDARD_ERROR_OF_MEAN|0.276||0.586|TWO_SIDED|95.0|-0.393|0.694||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.694|-0.393|0.586
70855460|NCT02880956|141198392|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|1.97|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855461|NCT02880956|141198392|SUPERIORITY||LS Mean of Difference|0.27|STANDARD_ERROR_OF_MEAN|0.324||0.412|TWO_SIDED|95.0|-0.371|0.903||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.903|-0.371|0.412
70855462|NCT02880956|141198392|SUPERIORITY||Effect size/pooled SD|0.12|STANDARD_DEVIATION|2.2|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855463|NCT02880956|141198392|SUPERIORITY||LS Mean of Difference|0.24|STANDARD_ERROR_OF_MEAN|0.319||0.45|TWO_SIDED|95.0|-0.386|0.868||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.868|-0.386|0.450
70944195|NCT02847637|141388242|SUPERIORITY||ABR Ratio|0.03|||<|0.0001|TWO_SIDED|95.0|0.014|0.067||Not controlled for type I error|Non-stratified Wald test||Arm A+Bnise: Emicizumab Prophylaxis is the numerator and Arm A+Bnise: Pre-Study Episodic FVIII is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio = 1. H1 (alternative hypothesis): ABR Ratio ≠ 1.||0.067|0.014|<0.0001
70855464|NCT02880956|141198392|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|2.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855465|NCT02880956|141198392|SUPERIORITY||LS Mean of Difference|0.17|STANDARD_ERROR_OF_MEAN|0.33||0.612|TWO_SIDED|95.0|-0.481|0.816||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.816|-0.481|0.612
70944196|NCT02847637|141388243|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.023|0.068||Not controlled for type I error|Non-stratified Wald test||Arm A+Bnise: Emicizumab Prophylaxis is the numerator and Arm A+Bnise: Pre-Study Episodic FVIII is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio = 1. H1 (alternative hypothesis): ABR Ratio ≠ 1.||0.068|0.023|<0.0001
71121125|NCT01340937|141748087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|-0.7|2.2|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, all routes \>=39.5°C||2.2|-0.7|
71121126|NCT01340937|141748087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.3|||||TWO_SIDED|95.0|-16.6|-5.9|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference; rectal \<38.0°C||-5.9|-16.6|
71121127|NCT01340937|141748087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5|||||TWO_SIDED|95.0|-1.4|7.8|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference; rectal \>=38.0°C and \<38.5°C||7.8|-1.4|
71121128|NCT01340937|141748087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.4|||||TWO_SIDED|95.0|4.6|11.6|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, rectal \>=38.5°C and \<39.5°C||11.6|4.6|
71121129|NCT01340937|141748087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|-0.7|2.1|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, rectal \>=39.5°C||2.1|-0.7|
70855466|NCT02880956|141198392|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|2.1|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70944197|NCT02847637|141388244|SUPERIORITY||Mean Difference (Final Values)|12.51||||0.0891|TWO_SIDED|95.0|-1.96|26.98||Statistical significance is controlled at the 2-sided, 0.05 alpha level.|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm A.|||26.98|-1.96|0.0891
71121130|NCT00623545|141748107|SUPERIORITY_OR_OTHER||Mean Difference (Net)|185.0|STANDARD_DEVIATION|240.0||0.001|TWO_SIDED|95.0||||The a prior threshold for statistical significance was p\< 0.05|ANOVA||units are kcal/d|Previously published literature showed an average weight loss of 1.8 kg at 12 weeks of exenatide treatment. This was converted to differ- ence in TEE, estimating an average imbalance of 2 kg × 7800 kcal·kg-1 divided by 84 days or 185 kcal·day-1.We demonstrated an average reproducibility of the DLW method of 6% or 240 kcal·day-1. For a 5% probability of finding this difference with a power of 80%, we determined a need for 14 subjects to complete the study.||||0.001
71121131|NCT00623545|141748107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71121132|NCT00623545|141748108|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis was that energy intake was unchanged between the period before treatment and at the end of treatment.||||< 0.05
71121133|NCT00623545|141748108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71121134|NCT03500172|141748115|SUPERIORITY|||||||0.455||||||Threshold for significance: 0.05|Two sample test of proportions|||||||0.455
71121135|NCT03500172|141748116|SUPERIORITY|||||||0.962||||||Statistical significance threshold: 0.05|Two sample test of proportions|||||||0.962
71121136|NCT03500172|141748117|SUPERIORITY||Hazard Ratio (HR)|0.78|||<|0.05|TWO_SIDED|95.0|0.61|0.99||Threshold for statistical significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU for steady partner, living together vs. single.||0.99|0.61|<0.05
70944198|NCT02847637|141388244|SUPERIORITY||Mean Difference (Final Values)|15.97||||0.0349|TWO_SIDED|95.0|1.16|30.78||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm B.|||30.78|1.16|0.0349
70944199|NCT02847637|141388245|SUPERIORITY||Mean Difference (Final Values)|5.91||||0.1269|TWO_SIDED|95.0|-1.72|13.55||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm A.|||13.55|-1.72|0.1269
70944200|NCT02847637|141388245|SUPERIORITY||Mean Difference (Final Values)|8.56||||0.0317|TWO_SIDED|95.0|0.77|16.35||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm B.|||16.35|0.77|0.0317
70944201|NCT02847637|141388246|SUPERIORITY||Mean Difference (Final Values)|-4.04||||0.3402|TWO_SIDED|95.0|-12.43|4.35||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm A.|||4.35|-12.43|0.3402
70944202|NCT02847637|141388246|SUPERIORITY||Mean Difference (Final Values)|-9.15||||0.0373|TWO_SIDED|95.0|-17.74|-0.55||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm B.|||-0.55|-17.74|0.0373
70944203|NCT02847637|141388247|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.006|TWO_SIDED|95.0|-0.22|-0.04||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm A.|||-0.04|-0.22|0.0060
70944204|NCT02847637|141388247|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.0059|TWO_SIDED|95.0|-0.23|-0.04||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm B.|||-0.04|-0.23|0.0059
70944205|NCT01670188|141388290|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
70944206|NCT01187407|141388315|SUPERIORITY_OR_OTHER|||||||0.997||||||Primary comparison.|Mixed Models Analysis|||||||0.997
70944207|NCT01187407|141388315|SUPERIORITY_OR_OTHER|||||||0.769||||||Secondary comparison.|Mixed Models Analysis|||||||0.769
70944208|NCT00776984|141388342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.091|0.217||Step-wise testing for co-primary endpoints, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.217|0.091|<0.0001
70944209|NCT00776984|141388343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.03||0.0002||95.0|0.053|0.169||Step-wise testing for co-primary endpoints, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.169|0.053|0.0002
70944210|NCT00776984|141388344|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0343||||||Confirmatory only if previous hypotheses for each of the 2 twin studies had been successful, significance level of alpha=0.05 (2-sided). A pre-specified interim analysis was performed. Cui et al (Biometrics,1999) was used to calculate the p-value.|Regression, Cox|Parameter estimates of Cox proportional hazard model regression regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|||||0.0343
70944211|NCT00776984|141388345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.042||0.0275||95.0|0.01|0.177||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.177|0.010|0.0275
70944212|NCT00776984|141388346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.041||0.0099||95.0|0.025|0.186||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.186|0.025|0.0099
70944213|NCT00776984|141388347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.084|0.202||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.202|0.084|<0.0001
70944214|NCT00776984|141388348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.109|STANDARD_ERROR_OF_MEAN|0.04||0.0063||95.0|0.031|0.187||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.187|0.031|0.0063
70944215|NCT00776984|141388349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.087|0.217||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.217|0.087|<0.0001
70944216|NCT00776984|141388350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.03||0.0026||95.0|0.032|0.151||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.151|0.032|0.0026
70944217|NCT00776984|141388351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.078|0.199||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.199|0.078|<0.0001
70954297|NCT00688870|141411084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.714||95.0|||||Fisher Exact|||For Decreased appetite, Fisher exact test was used to calculate p-value.||||0.714
70954298|NCT00688870|141411084|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Irritability, Fisher exact test was used to calculate p-value.||||>0.99
70855467|NCT02880956|141198393|SUPERIORITY||LS Mean of Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.405||0.52|TWO_SIDED|95.0|-1.058|0.535||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.535|-1.058|0.520
70855468|NCT02880956|141198393|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|3.52|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855469|NCT02880956|141198393|SUPERIORITY||LS Mean of Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.401||0.303|TWO_SIDED|95.0|-1.201|0.374||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.374|-1.201|0.303
70855470|NCT02880956|141198393|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|3.28|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855471|NCT02880956|141198393|SUPERIORITY||LS Mean of Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.412||0.23|TWO_SIDED|95.0|-1.307|0.315||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.315|-1.307|0.230
70855472|NCT02880956|141198393|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|3.53|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71081896|NCT03299101|141670976|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.15||0.757|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in SGA between day of surgery and 90 days postop.||||0.757
71121137|NCT03500172|141748117|SUPERIORITY||Hazard Ratio (HR)|1.6|||<|0.05|TWO_SIDED|95.0|1.02|2.51||Threshold for statistical significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU for 5-9 new clients in the past month vs. 0 clients in the past month.||2.51|1.02|<0.05
71081897|NCT03299101|141670977|SUPERIORITY|||||||0.362|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in 6 Minute Walk Test across all 4 time points.||||0.362
71081898|NCT03299101|141670977|SUPERIORITY||Mean Difference (Net)|25.52|STANDARD_ERROR_OF_MEAN|20.06||0.203|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in 6 Minute Walk Test between baseline and day of surgery.||||.203
71081899|NCT03299101|141670977|SUPERIORITY||Mean Difference (Net)|12.7|STANDARD_ERROR_OF_MEAN|13.77||0.357|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<0.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in 6 Minute Walk Test between baseline and 90 days postop.||||0.357
71081900|NCT03299101|141670977|SUPERIORITY||Mean Difference (Net)|21.48|STANDARD_ERROR_OF_MEAN|15.4||0.163|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<0.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in 6 Minute Walk Test between day of surgery and 90 days postop.||||0.163
71081901|NCT03299101|141670978|SUPERIORITY|||||||0.068|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change across all 4 time points.||||0.068
71081902|NCT03299101|141670978|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.02||0.043|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change between baseline and day of surgery.||||0.043
71081903|NCT03299101|141670978|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.092|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change between baseline and 90 days postop.||||0.092
71121138|NCT03500172|141748117|SUPERIORITY||Hazard Ratio (HR)|1.31|||<|0.05|TWO_SIDED|95.0|1.09|1.57||Threshold for statistical significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU for use of marijuana in the past 30 days vs. no marijuana use in the past 30 days||1.57|1.09|<0.05
71121139|NCT03500172|141748117|SUPERIORITY||Hazard Ratio (HR)|1.24|||<|0.05|TWO_SIDED|95.0|1.01|1.52||Threshold for statistical significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU among those experiencing physical violence in the past 6 months vs. no experience of physical violence in the past 6 months.||1.52|1.01|<0.05
71121140|NCT03500172|141748117|SUPERIORITY||Hazard Ratio (HR)|1.62|||<|0.05|TWO_SIDED|95.0|1.31|2.0||Threshold for statistical significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU among those who have experienced sexual violence in the past 6 months vs. those who have not||2.00|1.31|<0.05
71121141|NCT03500172|141748117|SUPERIORITY||Hazard Ratio (HR)|2.33|||<|0.05|TWO_SIDED|95.0|1.65|3.29||Threshold for statistical significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU among those with viral loads from 50-1000 copies/mL at baseline vs. \<50 copies/mL.||3.29|1.65|<0.05
71121142|NCT03500172|141748117|SUPERIORITY||Hazard Ratio (HR)|2.47|||<|0.05|TWO_SIDED|95.0|1.82|3.36||Threshold for significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU among those with viral load greater than 1000 copies/mL vs. those with viral load less than 50 copies/mL.||3.36|1.82|<0.05
71121143|NCT03500172|141748118|SUPERIORITY|||||||0.756||||||Threshold of significance: 0.05|Two sample test of proportions|||||||0.756
71121144|NCT03500172|141748119|SUPERIORITY|||||||0.295||||||Threshold of statistical significance: 0.05|Two sample test of proportions|||||||0.295
71121145|NCT03500172|141748120|SUPERIORITY|||||||0.149||||||Threshold for statistical significance: 0.05|Two sample test of proportions|||||||0.149
71121146|NCT03500172|141748121|SUPERIORITY|||||||0.301||||||Threshold of significance: 0.05|Two sample test of proportions|||||||0.301
70944218|NCT00776984|141388352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.044||0.0088||95.0|0.029|0.2||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.200|0.029|0.0088
70944219|NCT00776984|141388353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.071|STANDARD_ERROR_OF_MEAN|0.042||0.0933||95.0|-0.012|0.153||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.153|-0.012|0.0933
71121147|NCT03500172|141748124|SUPERIORITY|||||||0.212||||||Threshold of statistical significance: 0.05|Chi-squared|||||||0.212
70855473|NCT02880956|141198393|SUPERIORITY||LS Mean of Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.5222||0.2|TWO_SIDED|95.0|-1.698|0.356||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.356|-1.698|0.200
70855474|NCT02880956|141198393|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|4.07|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70944220|NCT00776984|141388354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.109|STANDARD_ERROR_OF_MEAN|0.041||0.0074||95.0|0.029|0.189||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.189|0.029|0.0074
71121148|NCT01035346|141748140|SUPERIORITY_OR_OTHER||Least-squares (LS) mean difference|8.33||||0.228|TWO_SIDED|95.0|-7.94|24.6||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95 percent (%) confidence interval (CI) were calculated based on Least-squares (LS) means from the Analysis of Variance (ANOVA) model.||24.60|-7.94|0.228
70855475|NCT02880956|141198393|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.508||0.873|TWO_SIDED|95.0|-1.08|0.917||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.917|-1.080|0.873
70944221|NCT00776984|141388355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.654|STANDARD_ERROR_OF_MEAN|4.807|<|0.0001||95.0|11.199|30.108||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||30.108|11.199|<0.0001
70954299|NCT00688870|141411084|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Increased sleep, Fisher exact test was used to calculate p-value.||||>0.99
71121149|NCT01035346|141748141|SUPERIORITY_OR_OTHER||LS mean difference|5.99||||0.171|TWO_SIDED|95.0|-3.99|15.97||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||STEMPD 0-4: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||15.97|-3.99|0.171
71081904|NCT03299101|141670978|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.292|TWO_SIDED||||||Mixed Models Analysis|The null hypothesis was rejected a priori if p\<.05.|The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MEP between day of surgery and 90 days postop.||||0.292
70855476|NCT02880956|141198393|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|4.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71081905|NCT03299101|141670979|SUPERIORITY|||||||0.625|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change across both time points.||||0.625
70855477|NCT02880956|141198393|SUPERIORITY||LS Mean of Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.524||0.388|TWO_SIDED|95.0|-1.482|0.576||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.576|-1.482|0.388
70855478|NCT02880956|141198393|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|3.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855479|NCT02880956|141198393|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.587||0.734|TWO_SIDED|95.0|-1.355|0.955||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.955|-1.355|0.734
70855480|NCT02880956|141198393|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|3.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855481|NCT02880956|141198393|SUPERIORITY||LS Mean of Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.579||0.417|TWO_SIDED|95.0|-1.608|0.668||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.668|-1.608|0.417
70855482|NCT02880956|141198393|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|4.14|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855483|NCT02880956|141198393|SUPERIORITY||LS Mean of Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.589||0.252|TWO_SIDED|95.0|-1.836|0.482||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.482|-1.836|0.252
70855484|NCT02880956|141198393|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|4.16|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855485|NCT02880956|141198393|SUPERIORITY||LS Mean of Difference|0.15|STANDARD_ERROR_OF_MEAN|0.669||0.827|TWO_SIDED|95.0|-1.17|1.462||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.462|-1.170|0.827
70855486|NCT02880956|141198393|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|4.69|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855487|NCT02880956|141198393|SUPERIORITY||LS Mean of Difference|0.33|STANDARD_ERROR_OF_MEAN|0.657||0.615|TWO_SIDED|95.0|-0.962|1.624||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|repeated measures model|||Week 96||1.624|-0.962|0.615
70855488|NCT02880956|141198393|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|4.61|||TWO_SIDED|||||||||Week 96||||
70855489|NCT02880956|141198393|SUPERIORITY||LS Mean of Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.678||0.637|TWO_SIDED|95.0|-1.653|1.014||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.014|-1.653|0.637
70855490|NCT02880956|141198393|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|4.89|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70944222|NCT00776984|141388356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.453|STANDARD_ERROR_OF_MEAN|5.044|<|0.0001||95.0|22.532|42.374||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||42.374|22.532|<0.0001
70954300|NCT00688870|141411084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.525||95.0|||||Fisher Exact|||For Decreased sleep, Fisher exact test was used to calculate p-value.||||0.525
70944223|NCT00776984|141388357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.03||0.0027||95.0|0.031|0.149||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.149|0.031|0.0027
71121150|NCT01035346|141748141|SUPERIORITY_OR_OTHER||LS mean difference|8.96||||0.354|TWO_SIDED|95.0|-14.78|32.69||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||STEMPD 0-8: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||32.69|-14.78|0.354
70944224|NCT00776984|141388358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.074|0.2||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.200|0.074|<0.0001
71081906|NCT02028507|141671003|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.003|TWO_SIDED|95.0|0.55|0.89|||Regression, Cox|||This statistical Analysis corresponds to Global health status/quality of life scale||0.89|0.55|0.003
71081907|NCT02028507|141671003|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.001|TWO_SIDED|95.0|0.5|0.76|||Regression, Cox|||This statistical Analysis corresponds to Physical functioning scale||0.76|0.50|<0.001
71081908|NCT02028507|141671003|SUPERIORITY||Hazard Ratio (HR)|0.63|||<|0.001|TWO_SIDED|95.0|0.51|0.79|||Regression, Cox|||This statistical Analysis corresponds to Role functioning scale||0.79|0.51|<0.001
71081909|NCT02028507|141671003|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.818|TWO_SIDED|95.0|0.76|1.25|||Regression, Cox|||This statistical Analysis corresponds to Emotional functioning scale||1.25|0.76|0.818
71081910|NCT02028507|141671003|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.004|TWO_SIDED|95.0|0.54|0.89|||Regression, Cox|||This statistical Analysis corresponds to Cognitive functioning scale||0.89|0.54|0.004
71081911|NCT02028507|141671003|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.001|TWO_SIDED|95.0|0.49|0.78|||Regression, Cox|||This Statistical Analysis corresponds to Social functioning scale||0.78|0.49|<0.001
71081912|NCT02028507|141671004|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.001|TWO_SIDED|95.0|0.57|0.86|||Regression, Cox|||This Statistical Analysis corresponds to Fatigue scale||0.86|0.57|0.001
71121151|NCT01035346|141748142|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.576|TWO_SIDED|95.0|-0.84|0.54||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.54|-0.84|0.576
70954301|NCT01821352|141411099|SUPERIORITY_OR_OTHER||||||<|5e-05|TWO_SIDED||||||Fisher Exact|||||||<0.00005
70954302|NCT01821352|141411100|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
71081913|NCT02028507|141671004|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.45|0.76|||Regression, Cox|||This Statistical Analysis corresponds to Nausea and vomiting scale||0.76|0.45|<0.001
71081914|NCT02028507|141671004|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.042|TWO_SIDED|95.0|0.62|0.99|||Regression, Cox|||This Statistical Analysis corresponds to Pain scale||0.99|0.62|0.042
71081915|NCT02028507|141671004|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.599|TWO_SIDED|95.0|0.81|1.44|||Regression, Cox|||This Statistical Analysis corresponds to Dyspnea scale||1.44|0.81|0.599
71081916|NCT02028507|141671004|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.196|TWO_SIDED|95.0|0.64|1.1|||Regression, Cox|||This Statistical Analysis corresponds to Insomnia scale||1.10|0.64|0.196
71081917|NCT02028507|141671004|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.011|TWO_SIDED|95.0|0.54|0.92|||Regression, Cox|||This Statistical Analysis corresponds to Appetite loss scale||0.92|0.54|0.011
71081918|NCT02028507|141671004|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.564|TWO_SIDED|95.0|0.83|1.41|||Regression, Cox|||This Statistical Analysis corresponds to Constipation scale||1.41|0.83|0.564
71081919|NCT02028507|141671004|SUPERIORITY||Hazard Ratio (HR)|0.42|||<|0.001|TWO_SIDED|95.0|0.32|0.55|||Regression, Cox|||This Statistical Analysis corresponds to Diarrhea scale||0.55|0.32|<0.001
71081920|NCT02028507|141671004|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.118|TWO_SIDED|95.0|0.56|1.07|||Regression, Cox|||This Statistical Analysis corresponds to Financial difficulties scale||1.07|0.56|0.118
71081921|NCT02028507|141671005|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.659|TWO_SIDED|95.0|0.74|1.21|||Regression, Cox|||This Statistical Analysis corresponds to Body image scale||1.21|0.74|0.659
71081922|NCT02028507|141671005|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.928|TWO_SIDED|95.0|0.74|1.39|||Regression, Cox|||This Statistical Analysis corresponds to Future perspective scale||1.39|0.74|0.928
71081923|NCT02028507|141671006|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.029|TWO_SIDED|95.0|0.64|0.98|||Regression, Cox|||This Statistical Analysis corresponds to Systemic side-effects scale||0.98|0.64|0.029
71081924|NCT02028507|141671006|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.571|TWO_SIDED|95.0|0.71|1.21|||Regression, Cox|||This Statistical Analysis corresponds to Breast symptoms scale||1.21|0.71|0.571
71081925|NCT02028507|141671006|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.187|TWO_SIDED|95.0|0.66|1.09|||Regression, Cox|||This Statistical Analysis corresponds to Arm symptoms scale||1.09|0.66|0.187
71081926|NCT02420262|141671011|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for IDegLira vs basal-bolus (IGlar + IAsp) was considered confirmed if the upper boundary of the two-sided 95% confidence interval was strictly below 0.30% or equivalent for non-inferiority using one-sided test for null hypothesis (H0): D ≥0.30% against alternative hypothesis (HA): D \<0.30% was less than or equal to 2.5%, where D is the mean treatment difference (IDegLira minus basal-bolus).|Treatment contrast|-0.02|||<|0.0001|TWO_SIDED|95.0|-0.16|0.12|||Mixed Models Analysis|||Change from baseline in HbA1c was analysed using a mixed model for repeated measurements with an unstructured covariance matrix. The model included treatment, visit and region as fixed factors and baseline HbA1c as covariate. Interactions between visit and all factors and the covariate were also included in the model.||0.12|-0.16|<0.0001
71121152|NCT01035346|141748142|SUPERIORITY_OR_OTHER||LS mean difference|0.18||||0.502|TWO_SIDED|95.0|-0.5|0.87||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.87|-0.50|0.502
71081927|NCT02420262|141671012|SUPERIORITY_OR_OTHER||Treatment ratio|0.11|||<|0.0001|TWO_SIDED|95.0|0.08|0.17|||Negative binomial regression model||Superiority for IDegLira vs basal-bolus was considered confirmed if the 95% confidence interval for the treatment rate ratio was entirely below 1.0.|Hypoglycaemic episodes were analysed using a negative binomial regression. The model included treatment and region as fixed factors and logarithm of the time period in which a hypoglycaemic episode considered treatment emergent as offset. The test for superiority of the confirmatory secondary endpoints was carried out only if non-inferiority of IDegLira vs basal-bolus for primary endpoint was confirmed.||0.17|0.08|<0.0001
71081928|NCT02420262|141671013|SUPERIORITY_OR_OTHER||Treatment difference|-3.57|||<|0.0001|TWO_SIDED|95.0|-4.19|-2.95|||Mixed Models Analysis||Superiority for IDegLira vs basal-bolus was considered confirmed if the 95% confidence interval for the treatment difference was below 0 or equal to zero.|Body weight measurements were analysed using a linear mixed model with an unstructured covariance matrix. The model included treatment, visit and region as fixed factors and baseline bodyweight as covariate. Interactions between visit and all factors and the covariate were also included in the model. The test for superiority of the confirmatory secondary endpoints was carried out only if non-inferiority of IDegLira vs basal-bolus for primary endpoint was confirmed.||-2.95|-4.19|<0.0001
71081929|NCT00436826|141671041|SUPERIORITY||Relative Risk|0.37|||<|0.001|TWO_SIDED|95.0|0.22|0.63|||Wald Chi-square|||||0.63|0.22|<0.001
71081930|NCT00784719|141671061|SUPERIORITY_OR_OTHER||Median|59.0|||||TWO_SIDED|80.0|57.0||Upper limit of 80% CI was not estimable as there were insufficient number of participants, who achieved \>=10 mm Schirmer test score in this reporting group, for the analysis.||||||||57.0|
71081931|NCT00784719|141671061|SUPERIORITY_OR_OTHER||Median|58.0|||||TWO_SIDED|80.0|58.0||Upper limit of 80% CI was not estimable as there were insufficient number of participants, who achieved \>=10 mm Schirmer test score in this reporting group, for the analysis.||||||||58.0|
71081932|NCT00784719|141671061|SUPERIORITY_OR_OTHER||Median|57.0|||||TWO_SIDED|80.0|29.0||Upper limit of 80% CI was not estimable as there were insufficient number of participants, who achieved \>=10 mm Schirmer test score in this reporting group, for the analysis.||||||||29.0|
71081933|NCT00784719|141671063|SUPERIORITY_OR_OTHER||Median|15.0|||||TWO_SIDED|80.0|9.0|28.0||||||||28.0|9.0|
71081934|NCT00784719|141671063|SUPERIORITY_OR_OTHER||Median|8.5|||||TWO_SIDED|80.0|8.0|27.0||||||||27.0|8.0|
71081935|NCT00784719|141671063|SUPERIORITY_OR_OTHER||Median|15.0|||||TWO_SIDED|80.0|15.0|27.0||||||||27.0|15.0|
71081936|NCT00784719|141671063|SUPERIORITY_OR_OTHER||Median|9.5|||||TWO_SIDED|80.0|8.0|15.0||||||||15.0|8.0|
71081937|NCT00784719|141671063|SUPERIORITY_OR_OTHER||Median|9.0|||||TWO_SIDED|80.0|8.0|15.0||||||||15.0|8.0|
71081938|NCT00784719|141671063|SUPERIORITY_OR_OTHER||Median|15.0|||||TWO_SIDED|80.0|8.0|43.0||||||||43.0|8.0|
71081939|NCT00784719|141671063|SUPERIORITY_OR_OTHER||Median|16.0|||||TWO_SIDED|80.0|15.0|30.0||||||||30.0|15.0|
71081940|NCT03131687|141671095|OTHER||Posterior Mean Difference|-1.0|STANDARD_DEVIATION|0.17|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
71081941|NCT03131687|141671095|OTHER||Posterior Mean Difference|-1.67|STANDARD_DEVIATION|0.17|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
71081942|NCT03131687|141671095|OTHER||Posterior Mean Difference|-1.83|STANDARD_DEVIATION|0.17|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
71081943|NCT03131687|141671095|OTHER||Posterior Mean Difference|-1.89|STANDARD_DEVIATION|0.17|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
71081944|NCT03131687|141671096|OTHER||Posterior Mean Difference|-0.89|STANDARD_DEVIATION|0.15|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
71081945|NCT03131687|141671096|OTHER||Posterior Mean Difference|-1.49|STANDARD_DEVIATION|0.15|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
71081946|NCT03131687|141671096|OTHER||Posterior Mean Difference|-1.62|STANDARD_DEVIATION|0.15|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
71081947|NCT03131687|141671096|OTHER||Posterior Mean Difference|-1.67|STANDARD_DEVIATION|0.15|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
71081948|NCT03131687|141671097|OTHER||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Models Analysis|||||-0.4|-1.2|<0.001
71081949|NCT03131687|141671097|OTHER||Median Difference (Final Values)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.2|-1.3|||Mixed Models Analysis|||||-1.3|-2.2|<0.001
71081950|NCT03131687|141671097|OTHER||Median Difference (Final Values)|-2.1|||<|0.001|TWO_SIDED|95.0|-2.5|-1.6|||Mixed Models Analysis|||||-1.6|-2.5|<0.001
71081951|NCT03131687|141671097|OTHER||Median Difference (Final Values)|-2.5|||<|0.001|TWO_SIDED|95.0|-2.9|-2.0|||Mixed Models Analysis|||||-2.0|-2.9|<0.001
71081952|NCT03131687|141671098|OTHER||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4|||Mixed Models Analysis|||||-0.4|-1.1|<0.001
71081953|NCT03131687|141671098|OTHER||Mean Difference (Final Values)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.0|-1.3|||Mixed Models Analysis|||||-1.3|-2.0|<0.001
71081954|NCT03131687|141671098|OTHER||Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.3|-1.5|||Mixed Models Analysis|||||-1.5|-2.3|<0.001
71081955|NCT03131687|141671098|OTHER||Mean Difference (Final Values)|-2.1|||<|0.001|TWO_SIDED|95.0|-2.4|-1.7|||Mixed Models Analysis|||||-1.7|-2.4|<0.001
71081956|NCT03131687|141671099|OTHER||Mean Difference (Final Values)|-0.5||||0.655|TWO_SIDED|95.0|-2.7|1.7|||Mixed Models Analysis|||||1.7|-2.7|0.655
71081957|NCT03131687|141671099|OTHER||Mean Difference (Final Values)|-4.4|||<|0.001|TWO_SIDED|95.0|-6.6|-2.3|||Mixed Models Analysis|||||-2.3|-6.6|<0.001
70944225|NCT00776984|141388359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.197|STANDARD_ERROR_OF_MEAN|0.741||0.1073||95.0|-0.261|2.655||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||2.655|-0.261|0.1073
70944226|NCT00776984|141388360|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.4788||95.0|0.65|1.23||Significance level of alpha=0.05 (two-sided).|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|||1.23|0.65|0.4788
70944227|NCT00776984|141388361|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.8|STANDARD_ERROR_OF_MEAN|0.11||0.1007||95.0|0.61|1.04||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo|||1.04|0.61|0.1007
70944228|NCT00776984|141388362|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96|STANDARD_ERROR_OF_MEAN|0.15||0.7906||95.0|0.71|1.3||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo|||1.30|0.71|0.7906
70944229|NCT00776984|141388363|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.57||||0.004||95.0|0.38|0.84||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95 percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo|||0.84|0.38|0.0040
70944230|NCT00776984|141388364|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.5481||95.0|0.58|1.32||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95 percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo|||1.32|0.58|0.5481
70944231|NCT00776984|141388365|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.7188||95.0|0.33|2.14||Significance level of alpha=0.05 (two-sided).|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|||2.14|0.33|0.7188
70944232|NCT00776984|141388366|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.95|STANDARD_ERROR_OF_MEAN|0.23||0.8503||95.0|0.59|1.54||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo.|||1.54|0.59|0.8503
70944233|NCT00776984|141388367|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.8129||95.0|0.29|2.46||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95 percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo|||2.46|0.29|0.8129
70944234|NCT00776984|141388368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.078||0.0225||95.0|0.025|0.331||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.331|0.025|0.0225
71081958|NCT03131687|141671099|OTHER||Mean Difference (Final Values)|-8.3|||<|0.001|TWO_SIDED|95.0|-10.5|-6.0|||Mixed Models Analysis|||||-6.0|-10.5|<0.001
71121153|NCT01035346|141748142|SUPERIORITY_OR_OTHER||LS mean difference|1.31||||0.116|TWO_SIDED|95.0|-0.51|3.12||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.12|-0.51|0.116
71121154|NCT01035346|141748142|SUPERIORITY_OR_OTHER||LS mean difference|1.58||||0.161|TWO_SIDED|95.0|-0.98|4.14||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.14|-0.98|0.161
71121155|NCT01035346|141748142|SUPERIORITY_OR_OTHER||LS mean difference|1.87||||0.215|TWO_SIDED|95.0|-1.66|5.41||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||5.41|-1.66|0.215
70944235|NCT00776984|141388369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.08||0.0803||95.0|-0.017|0.296||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.296|-0.017|0.0803
70944236|NCT00776984|141388370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.199|STANDARD_ERROR_OF_MEAN|0.067||0.003||95.0|-0.33|-0.068||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||-0.068|-0.330|0.0030
70944237|NCT00776984|141388371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.133|STANDARD_ERROR_OF_MEAN|0.069||0.0533||95.0|-0.267|0.002||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.002|-0.267|0.0533
70944238|NCT00776984|141388372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.028||0.6632||95.0|-0.043|0.067||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.067|-0.043|0.6632
71081959|NCT03131687|141671099|OTHER||Median Difference (Final Values)|-10.9|||<|0.001|TWO_SIDED|95.0|-13.3|-8.6|||Mixed Models Analysis|||||-8.6|-13.3|<0.001
71081960|NCT03131687|141671100|OTHER|||||||0.053|||||||Regression, Logistic|||||||0.053
71081961|NCT03131687|141671100|OTHER|||||||0.002|||||||Regression, Logistic|||||||0.002
71081962|NCT03131687|141671100|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71081963|NCT03131687|141671100|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71081964|NCT03131687|141671101|OTHER|||||||0.193|||||||Regression, Logistic|||||||0.193
71081965|NCT03131687|141671101|OTHER|||||||0.036|||||||Regression, Logistic|||||||0.036
70954303|NCT01821352|141411101|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71081966|NCT03131687|141671101|OTHER|||||||0.003|||||||Regression, Logistic|||||||0.003
71081967|NCT03131687|141671101|OTHER|||||||0.003|||||||Regression, Logistic|||||||0.003
71081968|NCT03131687|141671102|OTHER|||||||0.03|||||||Regression, Logistic|||||||0.030
71081969|NCT03131687|141671102|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71081970|NCT03131687|141671102|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71081971|NCT03131687|141671102|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71081972|NCT03131687|141671103|OTHER|||||||0.008|||||||Regression, Logistic|||||||0.008
71081973|NCT03131687|141671103|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71081974|NCT03131687|141671103|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71081975|NCT03131687|141671103|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71081976|NCT03131687|141671104|OTHER||Mean Difference (Final Values)|-22.4||||0.01|TWO_SIDED|95.0|-39.4|-5.3|||Mixed Models Analysis|||||-5.3|-39.4|0.010
71081977|NCT03131687|141671104|OTHER||Mean Difference (Final Values)|-56.2|||<|0.001|TWO_SIDED|95.0|-72.9|-39.5|||Mixed Models Analysis|||||-39.5|-72.9|<0.001
71081978|NCT03131687|141671104|OTHER||Odds Ratio (OR)|-76.3|||<|0.001|TWO_SIDED|95.0|-93.3|-59.2|||Mixed Models Analysis|||||-59.2|-93.3|<0.001
71081979|NCT03131687|141671104|OTHER||Mean Difference (Final Values)|-73.0|||<|0.001|TWO_SIDED|95.0|-90.9|-55.2|||Mixed Models Analysis|||||-55.2|-90.9|<0.001
71081980|NCT03131687|141671105|OTHER||Mean Difference (Final Values)|0.0||||0.396|TWO_SIDED|95.0|-0.1|0.0|||Mixed Models Analysis|||||0.0|-0.1|0.396
71121156|NCT01035346|141748142|SUPERIORITY_OR_OTHER||LS mean difference|1.17||||0.388|TWO_SIDED|95.0|-2.18|4.52||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.52|-2.18|0.388
70855491|NCT02880956|141198394|SUPERIORITY||LS Mean of Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.367||0.261|TWO_SIDED|95.0|-1.135|0.308||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.308|-1.135|0.261
71081981|NCT03131687|141671105|OTHER||Mean Difference (Final Values)|0.0||||0.903|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||||0.1|-0.1|0.903
71081982|NCT03131687|141671105|OTHER||Mean Difference (Final Values)|0.0||||0.536|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||||0.1|-0.1|0.536
71081983|NCT03131687|141671105|OTHER||Mean Difference (Final Values)|0.0||||0.325|TWO_SIDED|95.0|0.0|0.1|||Mixed Models Analysis|||||0.1|-0.0|0.325
71081984|NCT03131687|141671106|OTHER||Mean Difference (Final Values)|-0.1||||0.565|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|||||0.2|-0.4|0.565
71081985|NCT03131687|141671106|OTHER||Mean Difference (Final Values)|-0.4||||0.01|TWO_SIDED|95.0|-0.7|-0.1|||Mixed Models Analysis|||||-0.1|-0.7|0.010
71081986|NCT03131687|141671106|OTHER||Median Difference (Final Values)|-0.5||||0.001|TWO_SIDED|95.0|-0.9|-0.2|||Mixed Models Analysis|||||-0.2|-0.9|0.001
71081987|NCT03131687|141671106|OTHER||Median Difference (Final Values)|-0.6|||<|0.001|TWO_SIDED|95.0|-0.9|-0.3|||Mixed Models Analysis|||||-0.3|-0.9|<0.001
71081988|NCT03131687|141671107|OTHER||Mean Difference (Final Values)|-0.3||||0.164|TWO_SIDED|95.0|-0.7|0.1|||Mixed Models Analysis|||||0.1|-0.7|0.164
71081989|NCT03131687|141671107|OTHER||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4|||Mixed Models Analysis|||||-0.4|-1.1|<0.001
71081990|NCT03131687|141671107|OTHER||Mean Difference (Final Values)|-1.0|||<|0.001|TWO_SIDED|95.0|-1.4|-0.6|||Mixed Models Analysis|||||-0.6|-1.4|<0.001
71081991|NCT03131687|141671107|OTHER||Median Difference (Final Values)|-1.1|||<|0.001|TWO_SIDED|95.0|-1.5|-0.7|||Mixed Models Analysis|||||-0.7|-1.5|<0.001
71081992|NCT03131687|141671108|OTHER||Mean Difference (Final Values)|0.0||||0.919|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|||||0.3|-0.3|0.919
71081993|NCT03131687|141671108|OTHER||Mean Difference (Final Values)|-0.2||||0.194|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|||||0.1|-0.5|0.194
71081994|NCT03131687|141671108|OTHER||Mean Difference (Final Values)|-0.2||||0.145|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|||||0.1|-0.5|0.145
71081995|NCT03131687|141671108|OTHER||Mean Difference (Final Values)|-0.3||||0.067|TWO_SIDED|95.0|-0.6|0.0|||Mixed Models Analysis|||||0.0|-0.6|0.067
71081996|NCT03131687|141671109|OTHER||Mean Difference (Final Values)|-0.7||||0.539|TWO_SIDED|95.0|-3.1|1.6|||Mixed Models Analysis|||||1.6|-3.1|0.539
71081997|NCT03131687|141671109|OTHER||Mean Difference (Final Values)|-3.8||||0.001|TWO_SIDED|95.0|-6.1|-1.5|||Mixed Models Analysis|||||-1.5|-6.1|0.001
71081998|NCT03131687|141671109|OTHER||Mean Difference (Final Values)|-6.0|||<|0.001|TWO_SIDED|95.0|-8.4|-3.7|||Mixed Models Analysis|||||-3.7|-8.4|<0.001
71081999|NCT03131687|141671109|OTHER||Mean Difference (Final Values)|-8.8|||<|0.001|TWO_SIDED|95.0|-11.3|-6.4|||Mixed Models Analysis|||||-6.4|-11.3|<0.001
71082000|NCT01904032|141671126|SUPERIORITY||Mean Difference (Final Values)|0.7982|STANDARD_ERROR_OF_MEAN|2.0537||0.6982|TWO_SIDED|95.0|-3.2691|4.8656|||t-test, 2 sided|||The null hypothesis is that there is no difference in the CES-D change score between women who received high dose Vitamin D therapy versus low dose Vitamin D therapy.||4.8656|-3.2691|.6982
71082001|NCT01904032|141671127|SUPERIORITY||Mean Difference (Final Values)|-0.0424|STANDARD_ERROR_OF_MEAN|3.6619||0.9908|TWO_SIDED|95.0|-7.2946|7.2097|||t-test, 2 sided|||The null hypothesis is that there is no difference in the PAID change score between women who received high dose Vitamin D therapy versus low dose Vitamin D therapy.||7.2097|-7.2946|.9908
71082002|NCT01904032|141671128|SUPERIORITY||Mean Difference (Final Values)|0.4966|STANDARD_ERROR_OF_MEAN|3.1474||0.8749|TWO_SIDED|95.0|-5.7366|6.7298|||t-test, 2 sided|||The null hypothesis is that there is no difference in the change in systolic blood pressure between women who received high dose Vitamin D therapy versus low dose Vitamin D therapy.||6.7298|-5.7366|.8749
71082003|NCT01904032|141671129|SUPERIORITY||Mean Difference (Final Values)|1.5125|STANDARD_ERROR_OF_MEAN|1.8636||0.4187|TWO_SIDED|95.0|-2.1784|5.2033|||t-test, 2 sided|||The null hypothesis is that there is no difference in the change in diastolic blood pressure between women who received high dose Vitamin D therapy versus low dose Vitamin D therapy.||5.2033|-2.1784|.4187
71082004|NCT01903993|141671173|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69|||=|0.0106|TWO_SIDED|95.0|0.52|0.92|||Log rank (Stratified)|||Hazard ratios (HR) were estimated by a Cox regression model.||0.92|0.52|= 0.0106
71082005|NCT01903993|141671174|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|0.59|||=|0.8884|TWO_SIDED|95.0|-7.67|8.85|||Cochran-Mantel-Haenszel|||||8.85|-7.67|= 0.8884
71082006|NCT01903993|141671175|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92|||=|0.5563|TWO_SIDED|95.0|0.71|1.2|||Log rank (Stratified)|||HR were estimated by a Cox regression model. The two treatment comparison was based on a stratified log-rank test.||1.20|0.71|=0.5563
71082007|NCT01903993|141671176|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.32|||=|0.0028|TWO_SIDED|95.0|0.15|0.7|||Log rank (unstratified)|||HR were estimated by a unstratified Cox regression model.||0.70|0.15|= 0.0028
71082008|NCT01868165|141671202|OTHER||Slope|0.58|||||TWO_SIDED|95.0|-0.6|1.77|||||"Linear regression slope and 95% confidence intervals for the association between calcium channel blocker use and cognitive change was 0.58 (-0.60:1.77).~Multiple adjustments including; age, sex, education."|||1.77|-0.60|
71082009|NCT01603407|141671220|SUPERIORITY|||||||0.3904|||||||Mixed Models Analysis|||||||0.3904
71082010|NCT01603407|141671220|SUPERIORITY|||||||0.569|||||||Mixed Models Analysis|||||||0.5690
71082011|NCT01603407|141671220|SUPERIORITY|||||||0.1518|||||||Mixed Models Analysis|||||||0.1518
71082012|NCT01603407|141671221|SUPERIORITY|||||||0.7365|||||||Mixed Models Analysis|||||||0.7365
71082013|NCT01603407|141671221|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71082014|NCT01603407|141671221|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71082015|NCT01603407|141671222|SUPERIORITY|||||||0.2456|||||||Mixed Models Analysis|||||||0.2456
71082016|NCT01603407|141671222|SUPERIORITY|||||||0.0369|||||||Mixed Models Analysis|||||||0.0369
71082017|NCT01603407|141671222|SUPERIORITY|||||||0.3589|||||||Mixed Models Analysis|||||||0.3589
71082018|NCT01603407|141671223|SUPERIORITY|||||||0.7335|||||||Mixed Models Analysis|||||||0.7335
71082019|NCT01603407|141671223|SUPERIORITY|||||||0.0004|||||||Mixed Models Analysis|||||||0.0004
71082020|NCT01603407|141671223|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||||||0.0001
71082021|NCT01603407|141671224|SUPERIORITY|||||||0.9532|||||||Mixed Models Analysis|||||||0.9532
71082022|NCT01603407|141671224|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||||||0.0040
71082023|NCT01603407|141671224|SUPERIORITY|||||||0.0046|||||||Mixed Models Analysis|||||||0.0046
71082024|NCT01603407|141671225|SUPERIORITY|||||||0.332|||||||Mixed Models Analysis|||||||0.3320
71082025|NCT01603407|141671225|SUPERIORITY|||||||0.1248|||||||Mixed Models Analysis|||||||0.1248
71082026|NCT01603407|141671225|SUPERIORITY|||||||0.5854|||||||Mixed Models Analysis|||||||0.5854
71082027|NCT01603407|141671226|SUPERIORITY|||||||0.30814|||||||Mixed Models Analysis|||||||0.30814
71082028|NCT01603407|141671226|SUPERIORITY|||||||0.1405|||||||Mixed Models Analysis|||||||0.1405
71082029|NCT01603407|141671226|SUPERIORITY|||||||0.664|||||||Mixed Models Analysis|||||||0.6640
71082030|NCT01603407|141671228|SUPERIORITY|||||||0.8345|||||||Mixed Models Analysis|||||||0.8345
71082031|NCT01603407|141671228|SUPERIORITY|||||||0.3762|||||||Mixed Models Analysis|||||||0.3762
71082032|NCT01603407|141671228|SUPERIORITY|||||||0.5059|||||||Mixed Models Analysis|||||||0.5059
71082033|NCT01603407|141671229|SUPERIORITY|||||||0.5947|||||||Mixed Models Analysis|||||||0.5947
71082034|NCT01603407|141671229|SUPERIORITY|||||||0.1098|||||||Mixed Models Analysis|||||||0.1098
71082035|NCT01603407|141671229|SUPERIORITY|||||||0.2803|||||||Mixed Models Analysis|||||||0.2803
71082036|NCT01603407|141671230|SUPERIORITY|||||||0.3875|||||||Mixed Models Analysis|||||||0.3875
71082037|NCT01603407|141671230|SUPERIORITY|||||||0.424|||||||Mixed Models Analysis|||||||0.4240
71082038|NCT01603407|141671230|SUPERIORITY|||||||0.9683|||||||Mixed Models Analysis|||||||0.9683
71082039|NCT01603407|141671231|SUPERIORITY|||||||0.6161|||||||Mixed Models Analysis|||||||0.6161
71082040|NCT01603407|141671231|SUPERIORITY|||||||0.7302|||||||Mixed Models Analysis|||||||0.7302
71082041|NCT01603407|141671231|SUPERIORITY|||||||0.9007|||||||Mixed Models Analysis|||||||0.9007
71082042|NCT01603407|141671232|SUPERIORITY|||||||0.8138|||||||Mixed Models Analysis|||||||0.8138
71082043|NCT01603407|141671232|SUPERIORITY|||||||0.5995|||||||Mixed Models Analysis|||||||0.5995
71082044|NCT01603407|141671232|SUPERIORITY|||||||0.7616|||||||Mixed Models Analysis|||||||0.7616
71082045|NCT01603407|141671233|SUPERIORITY|||||||0.68|||||||Mixed Models Analysis|||||||0.6800
71082046|NCT01603407|141671233|SUPERIORITY|||||||0.4365|||||||Mixed Models Analysis|||||||0.4365
71082047|NCT01603407|141671233|SUPERIORITY|||||||0.7281|||||||Mixed Models Analysis|||||||0.7281
71082048|NCT01603407|141671234|SUPERIORITY||Mean Difference (Net)|-1.545||||0.0041|TWO_SIDED|98.3|-2.6611|-0.2479|||Mixed Models Analysis|||||-0.2479|-2.6611|0.0041
71082049|NCT01603407|141671234|SUPERIORITY||Mean Difference (Net)|0.9076||||0.9076|TWO_SIDED|98.3|-1.248|1.1331|||Mixed Models Analysis|||||1.1331|-1.248|0.9076
71082050|NCT01603407|141671234|SUPERIORITY||Mean Difference (Net)|1.3971||||0.0054|TWO_SIDED|98.3|0.2014|2.5927|||Mixed Models Analysis|||||2.5927|0.2014|0.0054
71082051|NCT01603407|141671235|SUPERIORITY||Mean Difference (Net)|-1.48|||<|0.0001|TWO_SIDED|98.3|-2.3242|-0.6358|||Mixed Models Analysis|||||-0.6358|-2.3242|<0.0001
71082052|NCT01603407|141671235|SUPERIORITY||Mean Difference (Net)|3.054|||<|0.0001|TWO_SIDED|98.3|2.2222|3.8857|||Mixed Models Analysis|||||3.8857|2.2222|<0.0001
71082053|NCT01603407|141671235|SUPERIORITY||Mean Difference (Net)|4.534|||<|0.0001|TWO_SIDED|98.3|3.6941|5.3738|||Mixed Models Analysis|||||5.3738|3.6941|<0.0001
71082054|NCT01603407|141671236|SUPERIORITY||Mean Difference (Net)|-0.6205||||0.0853|TWO_SIDED|98.3|-1.4845|0.2434|||Mixed Models Analysis|||||0.2434|-1.4845|0.0853
71082055|NCT01603407|141671236|SUPERIORITY||Mean Difference (Net)|-0.876||||0.0143|TWO_SIDED|98.3|-1.7292|-0.0229|||Mixed Models Analysis|||||-0.0229|-1.7292|0.0143
71082056|NCT01603407|141671236|SUPERIORITY||Mean Difference (Net)|-0.2555||||0.4731|TWO_SIDED|98.3|-1.1117|0.6007|||Mixed Models Analysis|||||0.6007|-1.1117|0.4731
71082057|NCT02500719|141671237|SUPERIORITY||Mean Difference (Net)|0.1319||||0.029|ONE_SIDED||||||t-test, 1 sided|||This test is to determine if the difference between engagement and disengagement of emotional arousal is increased by real-time neurofeedback guidance in PTSD participants.||||.029
71121157|NCT01035346|141748142|SUPERIORITY_OR_OTHER||LS mean difference|0.31||||0.849|TWO_SIDED|95.0|-3.98|4.61||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.61|-3.98|0.849
71121158|NCT01035346|141748144|SUPERIORITY_OR_OTHER||difference in proportion|11.11||||0.378|TWO_SIDED|95.0|-10.67|32.89||p-value was calculated using CMH general association test using table scores. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen sodium-Placebo) and its associated CI were calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportion and the corresponding standard errors.||32.89|-10.67|0.378
70855492|NCT02880956|141198394|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|3.12|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855493|NCT02880956|141198394|SUPERIORITY||LS Mean of Difference|0.29|STANDARD_ERROR_OF_MEAN|0.361||0.423|TWO_SIDED|95.0|-0.42|1.001||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||1.001|-0.420|0.423
70855494|NCT02880956|141198394|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|3.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855495|NCT02880956|141198394|SUPERIORITY||LS Mean of Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.371||0.322|TWO_SIDED|95.0|-1.097|0.361||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.361|-1.097|0.322
70855496|NCT02880956|141198394|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|2.48|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855497|NCT02880956|141198394|SUPERIORITY||LS Mean of Difference|0.27|STANDARD_ERROR_OF_MEAN|0.397||0.498|TWO_SIDED|95.0|-0.511|1.049||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.049|-0.511|0.498
70855498|NCT02880956|141198394|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|3.33|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855499|NCT02880956|141198394|SUPERIORITY||LS Mean of Difference|0.75|STANDARD_ERROR_OF_MEAN|0.386||0.052|TWO_SIDED|95.0|-0.006|1.51||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.510|-0.006|0.052
70855500|NCT02880956|141198394|SUPERIORITY||Effect size/pooled SD|0.23|STANDARD_DEVIATION|3.26|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855501|NCT02880956|141198394|SUPERIORITY||LS Mean of Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.398||0.597|TWO_SIDED|95.0|-0.993|0.572||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.572|-0.993|0.597
70855502|NCT02880956|141198394|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|2.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855503|NCT02880956|141198394|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.376||0.896|TWO_SIDED|95.0|-0.689|0.788||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.788|-0.689|0.896
70855504|NCT02880956|141198394|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|3.4|||TWO_SIDED|||||||||Week 72||||
70855505|NCT02880956|141198394|SUPERIORITY||LS Mean of Difference|0.53|STANDARD_ERROR_OF_MEAN|0.369||0.149|TWO_SIDED|95.0|-0.192|1.258||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.258|-0.192|0.149
70855506|NCT02880956|141198394|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|3.0|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855507|NCT02880956|141198394|SUPERIORITY||LS Mean of Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.376||0.522|TWO_SIDED|95.0|-0.98|0.499||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.499|-0.980|0.522
70855508|NCT02880956|141198394|SUPERIORITY||Effect size/pooled SD|-0.09|STANDARD_DEVIATION|2.82|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70944239|NCT00776984|141388373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.263|STANDARD_ERROR_OF_MEAN|0.189||0.1664||95.0|-0.635|0.11||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.110|-0.635|0.1664
70855509|NCT02880956|141198394|SUPERIORITY||LS Mean of Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.424||0.528|TWO_SIDED|95.0|-1.103|0.567||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.567|-1.103|0.528
70855510|NCT02880956|141198394|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|3.63|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855511|NCT02880956|141198394|SUPERIORITY||LS Mean of Difference|0.3|STANDARD_ERROR_OF_MEAN|0.416||0.474|TWO_SIDED|95.0|-0.519|1.116||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.116|-0.519|0.474
70855512|NCT02880956|141198394|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|3.2|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70944240|NCT00776984|141388374|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.0427|TWO_SIDED|95.0|1.01|1.73||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|Comparison at 24 weeks||1.73|1.01|0.0427
71082058|NCT01990768|141671238|SUPERIORITY||Odds Ratio (OR)|0.87||||0.1809|ONE_SIDED|||||Based on an interim futility analysis, a one-sided P-value less than .1028 was required to declare benefit.|Regression, Logistic|Analysis was adjusted for regional site. Missing outcomes were multiply imputed.|Odds ratio for unfavorable GOS-E (\<=4) for the Combined TXA Arms (numerator) vs. Placebo (denominator)|This study was designed with an asymmetric boundary for tests for treatment harm and benefit. The conventional 0.025 level was used to test for harm while a 0.1 level was used to determine benefit for this Phase II trial. Statistical significance for the primary analysis was conducted under a group-sequential design that included a single, interim futility analysis using a Wang-Tsiatis boundary with parameter 0.8 based on outcome data from the first 200 subjects.||||.1809
71082059|NCT03538691|141671257|SUPERIORITY||Hazard Ratio (HR)|1.138||||0.51|TWO_SIDED|95.0|0.776|1.669|||Log Rank||The hazard ratio and 95% confidence interval (CI) were derived from the Cox proportional hazard model with treatment as fixed effect.|||1.669|0.776|0.5100
71082060|NCT03538691|141671258|SUPERIORITY||Least Squares (LS) Mean Difference|0.23||||0.2393|TWO_SIDED|95.0|-0.16|0.62||P-value was derived from an ANCOVA model with treatment, pooled center as factor and Baseline value as covariance.|ANCOVA|||||0.62|-0.16|0.2393
71082061|NCT03538691|141671259|SUPERIORITY||Hazard Ratio (HR)|1.177||||0.3086|TWO_SIDED|95.0|0.857|1.615|||Log Rank||The hazard ratio and 95% CI were derived from the Cox proportional hazard model with treatment as fixed effect.|||1.615|0.857|0.3086
71121159|NCT01035346|141748145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48||||0.324|TWO_SIDED|95.0|-0.3|1.27||p-value was calculated using CMH test with modified ridit scores. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Ibuprofen sodium-Placebo) and the associated CI were calculated based on the weighted Gamma statistic.||1.27|-0.30|0.324
71121160|NCT01035346|141748146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53||||0.21|TWO_SIDED|95.0|-0.12|1.18||p-value was calculated using CMH test with modified ridit scores. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Ibuprofen sodium-Placebo) and the associated CI were calculated based on the weighted Gamma statistic.||1.18|-0.12|0.210
71121161|NCT01974752|141748147|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.3195|TWO_SIDED|95.0|0.48|1.27|||Log Rank|Factor for treatment and liver metastases|A hazard ratio \< 1 favours Selumetinib in combination with Dacarbazine|||1.27|0.48|0.3195
71121162|NCT01974752|141748149|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.94||||0.1284|TWO_SIDED|95.0|0.88|1.02|||ANCOVA|ANCOVA of log (W6/BL) tumour assessments with a factor for trt, and covariates for liver mets, log BL tumour size, and time from BL scan to rand.|A geometric least squares mean ratio \< 1 favours Selumetinib in combination with Dacarbazine|||1.02|0.88|0.1284
71121163|NCT01974752|141748150|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.4011|TWO_SIDED|95.0|0.39|1.46|||Log Rank|||||1.46|0.39|0.4011
71121164|NCT04754230|141748151|OTHER|||||||0.8|||||||two sided Z-test|This estimate uses two sided Z-test while assuming type I error=0.05||Comparison of bleeding at day 1||||0.8
71121165|NCT00445848|141748188|OTHER||proportion of participants|0.78|||||TWO_SIDED|95.0|0.67|0.85||||||The overall survival rate at year 1 was estimated using Kaplan-Meier.||0.85|0.67|
71121166|NCT00445848|141748188|OTHER||proportion of participants|0.57|||||TWO_SIDED|95.0|0.46|0.67||||||The overall survival rate at year 2 was estimated using Kaplan-Meier.||0.67|0.46|
71121167|NCT00445848|141748188|OTHER||proportion of participants|0.43|||||TWO_SIDED|95.0|0.32|0.53||||||The overall survival rate at year 3 was estimated using Kaplan-Meier.||0.53|0.32|
71082062|NCT03538691|141671260|SUPERIORITY|||||||0.603|||||||Chi-squared|||||||0.6030
71082063|NCT03538691|141671261|SUPERIORITY|||||||0.7081|||||||Chi-squared|||Week 21||||0.7081
71082064|NCT03538691|141671261|SUPERIORITY|||||||0.4589|||||||Chi-squared|||Week 23||||0.4589
71082065|NCT03538691|141671261|SUPERIORITY|||||||0.5314|||||||Chi-squared|||Week 25||||0.5314
71082066|NCT03538691|141671261|SUPERIORITY|||||||0.1433|||||||Chi-squared|||Week 29||||0.1433
71082067|NCT03538691|141671261|SUPERIORITY|||||||0.9636|||||||Chi-squared|||Week 33||||0.9636
71082068|NCT03538691|141671261|SUPERIORITY|||||||0.7596|||||||Chi-squared|||Week 37||||0.7596
71082069|NCT03538691|141671261|SUPERIORITY|||||||0.2402|||||||Chi-squared|||Week 41||||0.2402
71082070|NCT03538691|141671261|SUPERIORITY|||||||0.8363|||||||Chi-squared|||Week 45||||0.8363
71082071|NCT03538691|141671261|SUPERIORITY|||||||0.8308|||||||Chi-squared|||Week 46||||0.8308
71082072|NCT03538691|141671262|SUPERIORITY||LS Mean Difference|-0.12||||0.8806|TWO_SIDED|95.0|-1.73|1.49|||ANCOVA|P-value was derived from an ANCOVA model with treatment, pooled center as factor and Baseline value as covariance.||||1.49|-1.73|0.8806
71082073|NCT03538691|141671263|SUPERIORITY||LS Mean Difference|0.03||||0.7956|TWO_SIDED|95.0|-0.18|0.24|||ANCOVA|P-value was derived from an ANCOVA model with treatment, pooled center as factor and Baseline value as covariance.||||0.24|-0.18|0.7956
71082074|NCT03538691|141671264|SUPERIORITY||LS Mean Difference|0.15||||0.5223|TWO_SIDED|95.0|-0.31|0.61||P-value was derived from an ANCOVA model with treatment, pooled center as factor and Baseline value as covariance.|ANCOVA|||SDS Individual Item: Work/School||0.61|-0.31|0.5223
71082075|NCT03538691|141671264|SUPERIORITY||LS Mean Difference|0.36||||0.0904|TWO_SIDED|95.0|-0.06|0.77||P-value was derived from an ANCOVA model with treatment, pooled center as factor and Baseline value as covariance.|ANCOVA|||SDS Individual Item: Social Life||0.77|-0.06|0.0904
71082076|NCT03538691|141671264|SUPERIORITY||LS Mean Difference|0.25||||0.2289|TWO_SIDED|95.0|-0.16|0.67||P-value was derived from an ANCOVA model with treatment, pooled center as factor and Baseline value as covariance.|ANCOVA|||SDS Individual Item: Family Life||0.67|-0.16|0.2289
71082077|NCT06597084|141671269|OTHER||Percentiles of time to first US|92.0||||0.2081|TWO_SIDED|95.0|25.0|95.0|||Log Rank|||||95|25|0.2081
71082078|NCT06597084|141671275|OTHER||Overall Survival|||||0.0542|||||||Log Rank|||||||0.0542
71082079|NCT03479944|141671300|SUPERIORITY||Least Squares Mean Difference|-1.505|||<|0.0001|TWO_SIDED|95.0|-1.72|-1.289|||t-test based on MMRM|MMRM: Mixed Model for Repeated Measures|Least Squares Mean Difference from a Mixed Model for Repeated Measures|||-1.289|-1.720|<0.0001
71082080|NCT03479944|141671301|SUPERIORITY||Least Squares Mean Difference|1.2||||0.2602|TWO_SIDED|95.0|-0.9|3.3|||t-test based on MMRM|MMRM: Mixed Model for Repeated Measures|Least Squares Mean Difference from a Mixed Model for Repeated Measures|||3.3|-0.9|0.2602
71082081|NCT03479944|141671302|SUPERIORITY||Least Squares Mean Difference|-11.52|||||TWO_SIDED|95.0|-15.87|-7.18|||||Least Squares Mean Difference from a Mixed Model for Repeated Measures|||-7.18|-15.87|
70944241|NCT00776984|141388374|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.0001|TWO_SIDED|95.0|1.28|2.21||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|Comparison at 48 weeks||2.21|1.28|0.0001
70944242|NCT02573883|141388380|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||0.007
71082082|NCT02029274|141671305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.551|STANDARD_ERROR_OF_MEAN|11.5519||0.9621|TWO_SIDED|95.0|-22.447|23.549|||Repeated measures analysis|||||23.549|-22.447|0.9621
71082083|NCT02029274|141671305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-15.368|STANDARD_ERROR_OF_MEAN|10.9297||0.1637|TWO_SIDED|95.0|-37.128|6.391|||Repeated measures analysis|||||6.391|-37.128|0.1637
71082084|NCT02029274|141671305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-13.709|STANDARD_ERROR_OF_MEAN|11.6016||0.2409|TWO_SIDED|95.0|-36.806|9.388|||Repeated measures|||||9.388|-36.806|0.2409
71082085|NCT01243177|141671319|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"The hypothesis was as follows:~H0: \[S(t)LCM\] - \[S(t)CBZ-CR\] ≤ -12 % versus HA: \[S(t)LCM\] - \[S(t)CBZ-CR\] \> -12 %, where S(t) (t= 182 days) is the cumulative rate of subjects remaining seizure free for 6 months following stabilization at the last evaluated dose (also known as the survivorship function), and -12 % represents the noninferiority margin based on absolute difference."|Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-5.5|2.8|||Mantel Haenszel|The analysis was stratified based on the number of seizures in the 3 months preceding enrollment (≤ 2 and \>2).|The lower limit of the confidence interval was \>-12 %, noninferiority of LCM to CBZ-CR was demonstrated. Additionally, the lower confidence limit relative to the CBZ-CR seizure freedom rate was \>- 20 %.|This was a noninferiority assessment of Lacosamide versus Carbamazepine-CR for the proportion of subjects remaining seizure free for 6 months at the last evaluated dose.||2.8|-5.5|
71121168|NCT05074888|141748207|SUPERIORITY|||||||0.0016|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 4 weeks later row.||||0.0016
71121169|NCT05074888|141748208|SUPERIORITY|||||||0.3183|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 4 weeks later row.||||0.3183
71121170|NCT05074888|141748209|SUPERIORITY|||||||0.5805|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 4 weeks later row.||||0.5805
71082086|NCT01243177|141671320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"The hypothesis was as follows:~H0: \[S(t)LCM\] - \[S(t)CBZ-CR\] ≤ -12 % versus HA: \[S(t)LCM\] - \[S(t)CBZ-CR\] \> -12 %, where S(t) (t= 182 days) is the cumulative rate of subjects remaining seizure free for 6 months following stabilization at the last evaluated dose (also known as the survivorship function), and -12 % represents the noninferiority margin based on absolute difference."|Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-5.3|2.7|||Mantel Haenszel|The analysis was stratified based on the number of seizures in the 3 months preceding enrollment (≤ 2 and \>2).|The lower limit of the confidence interval was \>-12 %, noninferiority of LCM to CBZ-CR was demonstrated. Additionally, the lower confidence limit relative to the CBZ-CR seizure freedom rate was \>- 20 %.|This was a noninferiority assessment of Lacosamide versus Carbamazepine-CR for the proportion of subjects remaining seizure free for 6 months at the last evaluated dose.||2.7|-5.3|
71082087|NCT01919164|141671355|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.01|0.03||||||Descriptive statistics was provided for primary endpoint.||0.03|-0.01|
71082088|NCT01919164|141671355|SUPERIORITY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.01|0.04||||||Descriptive statistics was provided for primary endpoint.||0.04|-0.01|
71082089|NCT01919164|141671355|SUPERIORITY||Mean Difference (Final Values)|0.04|||||TWO_SIDED|95.0|0.02|0.06||||||Descriptive statistics was provided for primary endpoint.||0.06|0.02|
71082090|NCT01919164|141671355|SUPERIORITY||Mean Difference (Final Values)|0.05|||||TWO_SIDED|95.0|0.03|0.07||||||Descriptive statistics was provided for primary endpoint.||0.07|0.03|
71082091|NCT01431313|141671384|OTHER|Mixed effects model across all time points.||||||0.002|||||||Mixed Models Analysis|||||||0.002
71082092|NCT01431313|141671384|OTHER|Mixed effects model across all time points.||||||0.003|||||||Mixed Models Analysis|||||||0.003
70944243|NCT02573883|141388381|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
71082093|NCT01431313|141671384|OTHER|Mixed effects model across all time points.||||||0.66|||||||Mixed Models Analysis|||||||0.66
71082094|NCT01431313|141671386|OTHER|Mixed effects model across all time points.|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71082095|NCT01431313|141671386|OTHER|Mixed effects model across all time points.|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71082096|NCT01431313|141671386|OTHER|Mixed effects model across all time points.|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71082097|NCT01431313|141671387|OTHER|Mixed effects model across all time points.||||||0.8|||||||Mixed Models Analysis|||||||0.8
71082098|NCT01431313|141671387|OTHER|Mixed effects model across all time points.||||||0.01|||||||Mixed Models Analysis|||||||0.01
71082099|NCT01431313|141671387|OTHER|Mixed effects model across all time points.||||||0.01|||||||Mixed Models Analysis|||||||0.01
71082100|NCT01431313|141671388|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
71082101|NCT01431313|141671388|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
71082102|NCT01431313|141671388|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
71082103|NCT01431313|141671389|OTHER|Mixed effects model of concentrations measured at Pre-dose, 15 minutes post 45mg dose and 15 minutes post 90mg dose.|||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71082104|NCT01431313|141671389|OTHER|Mixed effects model of concentrations measured at Pre-dose, 15 minutes post 45mg dose and 15 minutes post 90mg dose.|||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71082105|NCT01431313|141671389|OTHER|Mixed effects model of concentrations measured at Pre-dose, 15 minutes post 45mg dose and 15 minutes post 90mg dose.|||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71082106|NCT01431313|141671390|OTHER|Mixed effects model of concentrations measured at Pre-dose, 15 minutes post 45mg dose and 15 minutes post 90mg dose.|||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71082107|NCT01431313|141671390|OTHER|Mixed effects model of concentrations measured at Pre-dose, 15 minutes post 45mg dose and 15 minutes post 90mg dose.|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71082108|NCT01431313|141671391|OTHER|Mixed effects model across all doses.|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71082109|NCT01431313|141671391|OTHER|Mixed effects model across all doses.||||||0.21|||||||Mixed Models Analysis|||||||0.21
71082110|NCT01431313|141671391|OTHER|Mixed effects model across all doses.||||||0.59|||||||Mixed Models Analysis|||||||0.59
70944244|NCT02573883|141388383|SUPERIORITY|||||||0.011|||||||Chi-squared|||||||0.011
70944245|NCT02573883|141388385|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
70944246|NCT00118703|141388412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094||||0.604|TWO_SIDED|95.0|-0.26|0.45|||ANCOVA|The analysis method was adjusted for Baseline rTNSS, country, age, and gender, in addition to treatment effect.||||0.45|-0.26|0.604
70944247|NCT00118703|141388413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061||||0.729|TWO_SIDED|95.0|-0.29|0.41|||ANCOVA|The analysis method was adjusted for Baseline iTNSS, country, age, and gender, in addition to treatment effect.||||0.41|-0.29|0.729
71082111|NCT00524771|141671406|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on a non-inferiority test of two exponential survival curves . These calculations are based on the following assumptions: 1) one-sided α of 0.025; 2) power (1-β) of 0.80; VTE incidence rate of 9.1 VTE/10.000 WY and 4) non-inferiority limit on hazard ratio of 2.|Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.5|1.5|||||Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.|Tested null hypothesis: VTE hazard ratio for NuvaRing vs. COCs is higher or equal to 2. This analysis represents the a priori defined primary statistical analysis.||1.5|0.5|
71082112|NCT00524771|141671406|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.4|1.7|||||Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.|Tested null hypothesis: VTE hazard ratio for NuvaRing vs. COC2 is higher or equal to 2.||1.7|0.4|
71082113|NCT00524771|141671406|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.3|2.2|||||Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.|Like analysis 1 (see above) but restricted to exposure period of less than 6 months.||2.2|0.3|
71082114|NCT00524771|141671406|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.3|2.6|||||Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.|Like analysis 1 (see above) but restricted to exposure period of 6 - 12 months.||2.6|0.3|
71082115|NCT00524771|141671406|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.3|2.3|||||Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.|Like analysis 1 (see above) but restricted to exposure period of \> 12 months.||2.3|0.3|
71082116|NCT00524771|141671407|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.2|2.3|||||The hazard ratio was adjusted for age, BMI, Smoking, and treated hypertension.|||2.3|0.2|
71082117|NCT00524771|141671407|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.2|2.6|||||Hazard ratio was adjusted for age, BMI, smoking, and treated hypertension.|||2.6|0.2|
71082118|NCT04819438|141671455|EQUIVALENCE|Acceptance criterion for bioequivalence analysis was that the 90% confidence interval for the Test/Reference ratio of Cmax geometric means was within the 80.00-125.00 range.|Geometric Mean Ratio|117.05|||<|0.0001|TWO_SIDED|90.0|110.43|124.06|||ANOVA|||||124.06|110.43|<0.0001
71082119|NCT04819438|141671456|EQUIVALENCE|Acceptance criterion for bioequivalence analysis was that the 90% confidence interval for the Test/Reference ratio of AUC0-t geometric means was within the 80.00-125.00 range.|Geometric Mean Ratio|111.82|||<|0.0001|TWO_SIDED|90.0|108.25|115.5|||ANOVA|||||115.50|108.25|<0.0001
71082120|NCT04819438|141671458|EQUIVALENCE|Acceptance criterion for bioequivalence analysis was that the 90% confidence interval for the Test/Reference ratio of AUC0-∞ geometric means was within the 80.00-125.00 range.|Geometric Mean Ratio|111.83|||<|0.0001|TWO_SIDED|90.0|108.19|115.29|||ANOVA|||||115.29|108.19|<0.0001
71082121|NCT03060291|141671504|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.549|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.549
71082122|NCT03060291|141671504|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.854|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.854
71082123|NCT03060291|141671504|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.469|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the web/mobile only as the reference group.|||||.469
71082124|NCT03060291|141671505|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.535|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.535
71082125|NCT03060291|141671505|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.081|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.081
71082126|NCT03060291|141671505|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.295|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the web/mobile only as the reference group.|||||.295
71082127|NCT03060291|141671506|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.149|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.149
71082128|NCT03060291|141671506|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.207|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.207
71082129|NCT03060291|141671506|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.871|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the web/mobile only as the reference group.|||||.871
71082130|NCT03060291|141671507|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.547|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.547
71082131|NCT03060291|141671507|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.575|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.575
71082132|NCT03060291|141671507|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.964|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the web/mobile only as the reference group.|||||.964
71082133|NCT03060291|141671508|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.236|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.236
71082134|NCT03060291|141671508|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.142|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.142
70944248|NCT00118703|141388414|SUPERIORITY_OR_OTHER|||||||0.064|||||||Regression, Logistic|Overall evaluation of response to therapy was illustrated and analyzed using logistic regression adjusting for age, gender, investigator, and treatmen||||||0.064
70944249|NCT00006436|141388455|SUPERIORITY|||||||0.1|||||||Two-tailed log rank test||||Compared the PFS of interim PET positive participants to the PFS of interim PET negative.|||0.10
70944250|NCT00942188|141388469|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.854|||||TWO_SIDED|95.0|-1.94|0.23|||ANCOVA|||||0.23|-1.94|
70944251|NCT00942188|141388469|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.252|||||TWO_SIDED|95.0|-2.48|-0.03|||ANCOVA|||||-0.03|-2.48|
70944252|NCT00942188|141388469|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61|||||TWO_SIDED|95.0|-1.76|0.54|||ANCOVA|||||0.54|-1.76|
71082135|NCT03060291|141671508|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.81|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the web/mobile only as the reference group.|||||.810
70944253|NCT00942188|141388470|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.995|||||TWO_SIDED|95.0|-9.82|3.83|||ANCOVA|||||3.83|-9.82|
70944254|NCT00942188|141388470|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.324|||||TWO_SIDED|95.0|-10.21|5.56|||ANCOVA|||||5.56|-10.21|
70944255|NCT00942188|141388470|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.635|||||TWO_SIDED|95.0|-9.16|5.89|||ANCOVA|||||5.89|-9.16|
71082136|NCT03060291|141671509|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.599|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.599
71082137|NCT03060291|141671509|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.523|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.523
71082138|NCT03060291|141671509|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.252|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the web/mobile only as the reference group.|||||.252
71082139|NCT03060291|141671510|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.867|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.867
71082140|NCT03060291|141671510|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.127|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.127
71082141|NCT03060291|141671510|SUPERIORITY||Mean Difference (Final Values)|-0.51||||0.101|TWO_SIDED||||||t-test, 2 sided||||Mean difference in slope with the web/mobile only as the reference group.|||.101
71082142|NCT00718094|141671511|SUPERIORITY|||||||0.03|||||||Fisher Exact|||||||0.03
71082143|NCT01556932|141671518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_DEVIATION|3.2541|||TWO_SIDED|||||||||||||
71082144|NCT01882803|141671519|OTHER||||||<=|0.0001||||||'\<=' represents '≤'|Exact Binomial Test|The p-value was calculated by 1-sided exact binomial test with the null hypothesis that ORR ≤30%.||ORR was tested against the null (≤30%) by 1-sided exact binomial test at 0.025 level.||||<=0.0001
71082145|NCT00705341|141671529|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Regression, Linear|||Log-linear generalized estimating equation (GEE) models were used to assess the dose effect on PC20.||||0.65
71082146|NCT00205660|141671555|SUPERIORITY|||||||0.03||||||The a priori threshold for statistical significance in this planned primary test was p\<0.05.|ANCOVA|||A repeated measures ANCOVA was used to test for a time by treatment condition interaction that would indicate differences between groups in change over time in the primary outcome. The null hypothesis was that there were no differences between groups in the change over time (time x treatment condition).||||0.03
70944256|NCT00942188|141388472|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|||||TWO_SIDED|95.0|-0.59|0.05||This is the estimated value for week 10 HbA1c.|ANCOVA|||||0.05|-0.59|
70944257|NCT00942188|141388472|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.369|||||TWO_SIDED|95.0|-0.74|0.0||This is the estimated value for HbA1c at Week 10.|ANCOVA|||||0.00|-0.74|
70944258|NCT00942188|141388472|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.227|||||TWO_SIDED|95.0|-0.59|0.13||This is the estimated value for HbA1c at Week 10.|ANCOVA|||||0.13|-0.59|
70944259|NCT00942188|141388472|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.267|||||TWO_SIDED|95.0|-0.61|0.08||This is the estimated value for HbA1c at week 12.|ANCOVA|||||0.08|-0.61|
70944260|NCT00942188|141388472|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.396|||||TWO_SIDED|95.0|-0.79|0.0||This is the estimated value for HbA1c at Week 12.|ANCOVA|||||0.00|-0.79|
71082147|NCT00205660|141671556|SUPERIORITY|||||||0.01||||||The a priori threshold for statistical significance in this planned primary test was p\<0.05.|ANCOVA|||A repeated measures ANCOVA was used to test for a time by treatment condition interaction that would indicate differences between groups in change over time in the primary outcome. The null hypothesis was that there were no differences between groups in the change over time (time x treatment condition).||||0.01
71082148|NCT01720524|141671560|SUPERIORITY||Least square (LS) mean difference|0.0|STANDARD_ERROR_OF_MEAN|1.02||0.985|TWO_SIDED|95.0|-2.08|2.04|||ANCOVA|||||2.04|-2.08|0.9850
71082149|NCT01720524|141671561|SUPERIORITY||Difference in percentage|7.6||||0.4935|TWO_SIDED|95.0|-14.1|29.3|||Chi-squared|||||29.3|-14.1|0.4935
71082150|NCT01720524|141671562|SUPERIORITY|||||||0.9885|||||||Log Rank|||||||0.9885
71082151|NCT01720524|141671563|SUPERIORITY|||||||0.491|||||||Log Rank|||||||0.4910
71082152|NCT01720524|141671564|SUPERIORITY||Difference in Percentage|3.8||||0.7065|TWO_SIDED|95.0|-15.2|22.9|||Fisher Exact|||Additional Treatment||22.9|-15.2|0.7065
71082153|NCT01720524|141671564|SUPERIORITY||Difference in Percentage|0.3|||>|0.999|TWO_SIDED|95.0|-18.5|18.5|||Fisher Exact|||ECMO||18.5|-18.5|>0.999
71082154|NCT01720524|141671564|SUPERIORITY||Difference in Percentage|6.9||||0.2373|TWO_SIDED|95.0|-5.5|22.8|||Fisher Exact|||Death||22.8|-5.5|0.2373
71082155|NCT01720524|141671565|SUPERIORITY||LS Mean Difference|3.9||||0.4984|TWO_SIDED|95.0|-7.5|15.3|||ANCOVA|||Hour 6||15.3|-7.5|0.4984
71082156|NCT01720524|141671565|SUPERIORITY||LS Mean Difference|4.1||||0.3956|TWO_SIDED|95.0|-5.5|13.7|||ANCOVA|||Hour 12||13.7|-5.5|0.3956
71082157|NCT01720524|141671565|SUPERIORITY||LS Mean Difference|-2.2||||0.4249|TWO_SIDED|95.0|-7.6|3.3|||ANCOVA|||Hour 24||3.3|-7.6|0.4249
71082158|NCT01720524|141671566|SUPERIORITY||LS Mean Difference|0.7||||0.7686|TWO_SIDED|95.0|-4.3|5.8|||ANCOVA|||Hour 6||5.8|-4.3|0.7686
71082159|NCT01720524|141671566|SUPERIORITY||LS Mean Difference|-8.0||||0.1112|TWO_SIDED|95.0|-17.8|1.9|||ANCOVA|||Hour 12||1.9|-17.8|0.1112
71082160|NCT01720524|141671566|SUPERIORITY||LS Mean Difference|-8.2||||0.2089|TWO_SIDED|95.0|-21.2|4.8|||ANCOVA|||Hour 24||4.8|-21.2|0.2089
70944261|NCT00942188|141388472|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.221|||||TWO_SIDED|95.0|-0.59|0.15||This is the estimated value for HbA1c at week 12.|ANCOVA|||||0.15|-0.59|
70944262|NCT00276016|141388476|SUPERIORITY_OR_OTHER_LEGACY|||||||0.561||95.0|||||ANOVA|||For endpoint||||0.561
70944263|NCT00276016|141388477|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANOVA|||For endpoint||||<.001
70944264|NCT00113269|141388490|SUPERIORITY_OR_OTHER||differences in event rates|-3.3||||0.4889|TWO_SIDED|95.305|-12.7|6.1|||Normal approximation|Analysis based on normal approximation using Greenwood's formula for standard error.|95.305% Confidence Interval is reported, as adjusted for interim analysis based on normal approximation using Greenwood's formula for standard error.|||6.1|-12.7|0.4889
70944265|NCT00113269|141388490|SUPERIORITY_OR_OTHER||differences in event rates|-15.7|||<|0.0001|TWO_SIDED|95.305|-21.9|-9.4|||normal approximation|Analysis based on normal approximation using Greenwood's formula for standard error.|95.305% Confidence Interval is reported, as adjusted for interim analysis based on normal approximation using Greenwood's formula for standard error.|||-9.4|-21.9|<0.0001
70944266|NCT00113269|141388491|SUPERIORITY_OR_OTHER||differences in event rates|2.7||||0.6533|TWO_SIDED|95.0|-9.0|14.3|||normal approximation|||||14.3|-9.0|0.6533
70944267|NCT00113269|141388491|SUPERIORITY_OR_OTHER||differences in event rates|-11.9||||0.0024|TWO_SIDED|95.0|-19.5|-4.2|||normal approximation|||||-4.2|-19.5|0.0024
71082161|NCT01720524|141671567|SUPERIORITY||LS Mean Difference|37.2||||0.0829|TWO_SIDED|95.0|-5.0|79.5|||ANCOVA|||Hour 6||79.5|-5.0|0.0829
71082162|NCT01720524|141671567|SUPERIORITY||LS Mean Difference|26.6||||0.1802|TWO_SIDED|95.0|-12.7|65.9|||ANCOVA|||Hour 12||65.9|-12.7|0.1802
71082163|NCT01720524|141671567|SUPERIORITY||LS Mean Difference|79.9||||0.1576|TWO_SIDED|95.0|-32.5|192.2|||ANCOVA|||Hour 24||192.2|-32.5|0.1576
70944268|NCT00113269|141388492|SUPERIORITY_OR_OTHER||differences in event rates|-6.1||||0.4087|TWO_SIDED|95.0|-20.7|8.4|||normal approximation|||||8.4|-20.7|0.4087
70944269|NCT00113269|141388492|SUPERIORITY_OR_OTHER||differences in event rates|-8.7||||0.0456|TWO_SIDED|95.0|-17.2|-0.2|||normal approximation|||||-0.2|-17.2|0.0456
70944270|NCT00113269|141388493|SUPERIORITY_OR_OTHER||differences in event rates|1.1||||0.8742|TWO_SIDED|95.0|-12.7|15.0|||normal approximation|||||15.0|-12.7|0.8742
70944271|NCT00113269|141388493|SUPERIORITY_OR_OTHER||differences in event rates|-14.1||||0.001|TWO_SIDED|95.0|-22.5|-5.7|||normal approximation|||||-5.7|-22.5|0.0010
70944272|NCT00113269|141388495|SUPERIORITY_OR_OTHER||differences in event rates|3.5||||0.4134|TWO_SIDED|95.0|-4.8|11.7|||normal approximation|Analysis based on normal approximation using Greenwood's formula for standard error.||||11.7|-4.8|0.4134
70944273|NCT00113269|141388495|SUPERIORITY_OR_OTHER||differences in event rates|2.4||||0.2459|TWO_SIDED|95.0|-1.7|6.5|||normal approximation|Analysis based on normal approximation using Greenwood's formula for standard error.||||6.5|-1.7|0.2459
71121171|NCT05074888|141748210|SUPERIORITY|||||||0.2143|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 4 weeks later row.||||0.2143
71121172|NCT05074888|141748211|SUPERIORITY|||||||0.8156|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between value after 4 weeks and after 8 weeks row.||||0.8156
71121173|NCT05074888|141748212|SUPERIORITY|||||||0.1049|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between value after 4 weeks and after 8 weeks row.||||0.1049
71121174|NCT05074888|141748213|SUPERIORITY|||||||0.726|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between value after 4 weeks and after 8 weeks row.||||0.7260
70944274|NCT00113269|141388496|SUPERIORITY_OR_OTHER||differences in event rates|6.0||||0.3155|TWO_SIDED|95.0|-5.7|17.6|||normal approximation|||||17.6|-5.7|0.3155
70944275|NCT00113269|141388496|SUPERIORITY_OR_OTHER||differences in event rates|-0.4||||0.9045|TWO_SIDED|95.0|-6.5|5.7|||normal approximation|||||5.7|-6.5|0.9045
70944276|NCT00113269|141388497|SUPERIORITY_OR_OTHER||differences in event rates|1.6||||0.5265|TWO_SIDED|95.0|-3.4|6.7|||normal approximation|Analysis based on normal approximation using Greenwood's formula for standard error.||||6.7|-3.4|0.5265
70944277|NCT00113269|141388497|SUPERIORITY_OR_OTHER||differences in event rates|-0.6||||0.682|TWO_SIDED|95.0|-3.4|2.2|||normal approximation|Analysis based on normal approximation using Greenwood's formula for standard error.||||2.2|-3.4|0.6820
70944278|NCT00113269|141388498|SUPERIORITY_OR_OTHER||differences in event rates|5.9||||0.1797|TWO_SIDED|95.0|-2.7|14.4|||normal approximation|||||14.4|-2.7|0.1797
70944279|NCT00113269|141388498|SUPERIORITY_OR_OTHER||differences in event rates|-1.4||||0.5655|TWO_SIDED|95.0|-6.3|3.4|||normal approximation|||||3.4|-6.3|0.5655
70944280|NCT00113269|141388499|SUPERIORITY_OR_OTHER|||||||0.4735||95.0|||||ANCOVA|Analysis tests the difference between treatment groups for the mean change from month 1 with the month 1 value as covariate.||P-Value applies to 'Change from Month 1'||||0.4735
70944281|NCT00113269|141388499|SUPERIORITY_OR_OTHER|||||||0.1186||95.0|||||ANCOVA|Analysis tests the difference between treatment groups for the mean change from month 1 with the month 1 value as covariate.||P-Value applies to 'Change from Month 1'||||0.1186
70944282|NCT00113269|141388500|SUPERIORITY_OR_OTHER|||||||0.5231||95.0|||||ANCOVA|Analysis tests the difference between treatment groups for the mean change from month 1 with the month 1 value as covariate.||P-Value applies to 'Change from Month 1'||||0.5231
70944283|NCT00113269|141388500|SUPERIORITY_OR_OTHER|||||||0.122||95.0|||||ANCOVA|Analysis tests the difference between treatment groups for the mean change from month 1 with the month 1 value as covariate.||P-Value applies to 'Change from Month 1'||||0.1220
71082164|NCT00996034|141671592|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||This is a comparison of scan 1 and scan 2||||<0.05
71082165|NCT00158262|141671602|SUPERIORITY||Mean Difference (Final Values)|7.0|||||TWO_SIDED|95.0|-2.7|16.7|||||Placebo-Propranolol|||16.7|-2.7|
71082166|NCT00158262|141671603|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-15.5|15.3|||||Placebo-Propranolol|CAPS Total Score at Month 1||15.3|-15.5|
71082167|NCT00158262|141671603|SUPERIORITY||Mean Difference (Final Values)|-2.2|||||TWO_SIDED|95.0|-20.3|16.0||||||CAPS Total Score at Month 3||16.0|-20.3|
71082168|NCT00158262|141671604|SUPERIORITY||Mean Difference (Final Values)|2.9|||||TWO_SIDED|95.0|-4.8|10.7|||||Placebo-Propranolol|||10.7|-4.8|
71121175|NCT05074888|141748214|SUPERIORITY|||||||0.6808|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between value after 4 weeks and after 8 weeks row.||||0.6808
71082169|NCT00527826|141671605|NON_INFERIORITY_OR_EQUIVALENCE|Negative binomial model for the rate of exacerbations (per year) using the treatment duration as offset term and treatment, COPD severity (stratum) and interaction as fixed factors. This model took further into account a strata imbalance of 73% COPD III vs. 27% COPD IV according to the observed rates (SAS code: proc GENMOD).||||||0.73||95.0|||||Negative binomial model|Least square means adjusted for COPD severity (stratum), interaction of stratum with treatment, and strata imbalance of 73% COPD III vs. 27% COPD IV.||||||0.73
71082170|NCT00527826|141671607|NON_INFERIORITY_OR_EQUIVALENCE|Poisson model for the rate of exacerbations (per year) using the treatment duration as offset term and treatment, COPD severity (stratum) and interaction as fixed factors. This model took further into account a strata imbalance of 73% COPD III vs. 27% COPD IV according to the observed rates (SAS code: proc GENMOD).||||||0.66||95.0|||||Poisson model|Least square means adjusted for COPD severity (stratum), interaction of stratum with treatment, and strata imbalance of 73% COPD III vs. 27% COPD IV.||||||0.66
71082171|NCT02585713|141671648|SUPERIORITY|||||||0.1316|||||||Log Rank|||||||0.1316
71082172|NCT03173456|141671650|SUPERIORITY|||||||0.69||||||A priori threshold for statistical significance was 0.05. The plan was to only do individual comparisons between means if the overall test of the analysis of variance (AVOVA) was statistically significant|ANOVA|||The null hypothesis is that all means are equal. The alternate hypothesis is that one or more mean is less than or more than another.||||0.69
71082173|NCT03173456|141671651|SUPERIORITY|||||||0.85||||||Threshold for statistical significance was 0.05. The plan was to only compare means if the overall test of AVOVA was statistically significant.|ANOVA|||||||0.85
71082174|NCT03173456|141671652|SUPERIORITY|||||||0.99||||||Threshold for statistical significance = 0.05|Chi-squared|||||||0.99
71082175|NCT03173456|141671654|SUPERIORITY|||||||0.46|||||||Chi-squared|||||||0.46
71082176|NCT03173456|141671655|SUPERIORITY|||||||0.0501||||||0.05 was the a priori threshold for statistical significance|Chi-squared|||||||0.0501
71082177|NCT01733121|141671656|OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|TWO_SIDED|95.0|-4.5|-1.6|||ANCOVA|||||-1.6|-4.5|<.0001
71121176|NCT05074888|141748215|SUPERIORITY|||||||0.54||||||"The p-value associated with treatment\*visit interaction of pulse rate (heart rate) from Visit 1 to 3 between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.54
71082178|NCT01733121|141671657|OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||ANOVA|||||-0.4|-1.2|<0.0001
71082179|NCT01733121|141671658|OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|0.7||0.0005|TWO_SIDED|95.0|-3.7|-1.1|||ANCOVA|||||-1.1|-3.7|0.0005
71082180|NCT01733121|141671659|OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.2|-0.5|||ANOVA|||||-0.5|-1.2|<.0001
71082181|NCT04501952|141671676|SUPERIORITY||Hazard Ratio (HR)|0.134||||0.0076|TWO_SIDED|95.0|0.031|0.586|||Regression, Cox|P-value was estimated using the Cox regression with baseline stratification factors as covariates.|Hazard ratio and two-sided 95% confidence interval (CI) were estimated using the Cox regression with baseline stratification factors as covariates.|||0.586|0.031|0.0076
71082182|NCT04501952|141671678|SUPERIORITY||Hazard Ratio (HR)|0.191||||0.0024|TWO_SIDED|95.0|0.065|0.555|||Regression, Cox|P-value was estimated using the Cox regression with baseline stratification factors as covariates.|Hazard ratio and two-sided 95% CI were estimated using the Cox regression with baseline stratification factors as covariates.|||0.555|0.065|0.0024
71082183|NCT04501952|141671681|SUPERIORITY||Hazard Ratio (HR)|0.134||||0.0076|TWO_SIDED|95.0|0.031|0.586|||Regression, Cox|P-value were estimated using the Cox regression with baseline stratification factors as covariates.|Hazard ratio and two-sided 95% CI were estimated using the Cox regression with baseline stratification factors as covariates.|||0.586|0.031|0.0076
71082184|NCT04501952|141671682|SUPERIORITY||Hazard Ratio (HR)|0.1||||0.0019|TWO_SIDED|95.0|0.023|0.43|||Regression, Cox|P-value were estimated using the Cox regression with baseline stratification factors as covariates.|Hazard ratio and two-sided 95% CI were estimated using the Cox regression with baseline stratification factors as covariates.|||0.430|0.023|0.0019
71082185|NCT04501952|141671683|SUPERIORITY||Least Squares Mean|0.07|STANDARD_ERROR_OF_MEAN|0.09||0.4318|TWO_SIDED|95.0|-0.1|0.24|||ANCOVA|P-value were from an ANCOVA model with baseline viral load as a covariate.|Least squares Mean (LSM), standard error (SE) and 95% CI were from an ANCOVA model with baseline viral load as a covariate.|||0.24|-0.10|0.4318
71082186|NCT04501952|141671684|SUPERIORITY||Hazard Ratio (HR)|1.405||||0.2987|TWO_SIDED|95.0|0.733|2.693|||Log Rank|p-value was based on stratified log-rank test with baseline stratification factor as strata.|Hazard ratio and two-sided 95% CI were estimated using the Cox regression with baseline stratification factors as covariates.|||2.693|0.733|0.2987
71082187|NCT04501952|141671686|SUPERIORITY|||||||0.2163|||||||Fisher Exact|||||||0.2163
71082188|NCT02080364|141671690|SUPERIORITY|||||||0.3386||||||p-value for comparison to Placebo|Mixed Models Analysis|||||||0.3386
71082189|NCT02080364|141671690|SUPERIORITY|||||||0.1992||||||p-value for compairons to Placebo|Mixed Models Analysis|||||||0.1992
71082190|NCT02080364|141671691|SUPERIORITY|||||||0.9394||||||p-value for comparison to Placebo.|Mixed Models Analysis|||||||0.9394
71082191|NCT02080364|141671691|SUPERIORITY||||||||||||||||||MMRM model does not converge. LS Mean and p-value are NA.|||
71082192|NCT02609984|141671701|OTHER||Hazard Ratio (HR)|0.8568||||0.49|TWO_SIDED|95.0|0.5507|1.333||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank||Hazard ratio is from Cox proportional hazards model stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|||1.3330|0.5507|0.4900
71082193|NCT02609984|141671702|OTHER||Hazard Ratio (HR)|1.2145||||0.4737|TWO_SIDED|95.0|0.7131|2.0684||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank||Hazard ratio is from Cox proportional hazards model stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|||2.0684|0.7131|0.4737
71082194|NCT02609984|141671706|OTHER|||||||0.3645||||||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank|||||||0.3645
71082195|NCT02609984|141671707|OTHER|||||||0.3466||||||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank|||||||0.3466
71082196|NCT02609984|141671708|OTHER||Hazard Ratio (HR)|0.7006||||0.1622|TWO_SIDED|95.0|0.4241|1.1574||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank||Hazard ratio is from Cox proportional hazards model stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|||1.1574|0.4241|0.1622
70855513|NCT02880956|141198394|SUPERIORITY||LS Mean of Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.429||0.441|TWO_SIDED|95.0|-1.176|0.513||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.513|-1.176|0.441
70855514|NCT02880956|141198394|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|3.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855515|NCT02880956|141198395|SUPERIORITY||LS Mean of Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.331||0.027|TWO_SIDED|95.0|-1.383|-0.082||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||-0.082|-1.383|0.027
70855516|NCT02880956|141198395|SUPERIORITY||Effect size/pooled SD|-0.26|STANDARD_DEVIATION|2.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71082197|NCT02609984|141671709|OTHER||Hazard Ratio (HR)|1.1849||||0.6397|TWO_SIDED|95.0|0.5817|2.4134||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank||Hazard ratio is from Cox proportional hazards model stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|||2.4134|0.5817|0.6397
71082198|NCT02609984|141671710|OTHER|||||||0.1128|||||||exact Pearson chi-square test|||||||0.1128
71082199|NCT02609984|141671711|OTHER||||||<|0.0001|||||||exact Pearson chi-square test|||||||<0.0001
71082200|NCT02609984|141671712|OTHER|||||||0.405|||||||exact Pearson chi-square test|||||||0.4050
71082201|NCT02609984|141671713|OTHER|||||||0.0127|||||||exact Pearson chi-square test|||||||0.0127
71082202|NCT02504320|141671715|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|1.0848|||||TWO_SIDED|90.0|0.9528|1.235|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen A) and reference (Regimen D).||1.2350|0.9528|
71082203|NCT02504320|141671715|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|0.7709|||||TWO_SIDED|90.0|0.6767|0.8782|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen B) and reference (Regimen D).||0.8782|0.6767|
71082204|NCT02504320|141671715|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|0.9389|||||TWO_SIDED|90.0|0.8246|1.0689|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen C) and reference (Regimen D).||1.0689|0.8246|
71121177|NCT05074888|141748216|SUPERIORITY|||||||0.49||||||"The p-value associated with treatment\*visit interaction of respiration rate (breathing rate) from Visit 1 to 3 between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.49
71121178|NCT05074888|141748217|SUPERIORITY|||||||0.87||||||"The p-value associated with treatment\*visit interaction of systolic blood pressure from Visit 1 to 3 between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to SBP/Visit1, SBP/Visit2 and SBP/Visit3 rows.||||0.87
71121179|NCT05074888|141748217|SUPERIORITY|||||||0.22||||||"The p-value associated with treatment\*visit interaction of diastolic blood pressure from Visit 1 to 3 between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to DBP/Visit1, DBP/Visit2 and DBP/Visit3 rows.||||0.22
71121180|NCT05074888|141748218|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71121181|NCT05074888|141748219|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71121182|NCT05074888|141748220|SUPERIORITY|||||||0.17|||||||Fisher Exact|||||||0.17
71121183|NCT05074888|141748221|SUPERIORITY|||||||0.004|||||||Fisher Exact|||||||0.004
71121184|NCT03541187|141748229|SUPERIORITY|The comparison between arms will be conducted using an analysis of covariance (ANCOVA) model, in which the change from the baseline to the 12-month TNSS mean serves as the outcome. The ANCOVA model will incorporate factors for treatment while adjusting for both the baseline TNSS mean and site.|Least Square Mean Difference|-0.23||||0.63|TWO_SIDED|95.0|-1.15|0.7|||ANCOVA|||||0.70|-1.15|0.63
71082205|NCT02504320|141671716|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|1.0435|||||TWO_SIDED|90.0|0.984|1.1066|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen A) and reference (Regimen D).||1.1066|0.9840|
71121185|NCT03541187|141748231|SUPERIORITY||Least Square Means Difference|-0.17||||0.69|TWO_SIDED|95.0|-0.99|0.66|||ANCOVA|||||0.66|-0.99|0.69
70855517|NCT02880956|141198395|SUPERIORITY||LS Mean of Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.328||0.146|TWO_SIDED|95.0|-1.123|0.167||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.167|-1.123|0.146
71082206|NCT02504320|141671716|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|0.8777|||||TWO_SIDED|90.0|0.8274|0.9311|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen B) and reference (Regimen D).||0.9311|0.8274|
71082207|NCT02504320|141671716|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|0.954|||||TWO_SIDED|90.0|0.8996|1.0117|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen A) and reference (Regimen D).||1.0117|0.8996|
71082208|NCT02504320|141671717|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|1.0283|||||TWO_SIDED|90.0|0.9691|1.0911|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen A) and reference (Regimen D).||1.0911|0.9691|
71082209|NCT02504320|141671717|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|0.9056|||||TWO_SIDED|90.0|0.8516|0.963|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen B) and reference (Regimen D).||0.9630|0.8516|
71082210|NCT02504320|141671717|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimates|0.9463|||||TWO_SIDED|90.0|0.8909|1.0051|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen C) and reference (Regimen D).||1.0051|0.8909|
71082211|NCT00086450|141671723|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|7.9||||0.005||95.0|3.3|12.5|||Regression, Cox|||||12.5|3.3|0.005
71082212|NCT00086450|141671724|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.74||||0.004||95.0|1.91|3.89|||Regression, Cox|||||3.89|1.91|0.004
71121186|NCT03541187|141748232|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.51|TWO_SIDED|95.0|0.42|1.54|||Regression, Cox||At the reactive dose of 15.4 mcg/mL after 12 months, there were 11 participants who were right-censored in the Cockroach SCIT arm and 8 participants who were right-censored in the Placebo arm.|||1.54|0.42|.51
71121187|NCT03541187|141748233|SUPERIORITY||Least Square Means Difference|-0.03||||0.91|TWO_SIDED|95.0|-0.54|0.49|||ANCOVA|||||0.49|-0.54|0.91
71121188|NCT03541187|141748234|SUPERIORITY||Least Square Means Difference|5.32|||<|0.001|TWO_SIDED|95.0|4.77|5.87|||ANCOVA|||||5.87|4.77|<0.001
71121189|NCT01310400|141748263|NON_INFERIORITY_OR_EQUIVALENCE|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|4.5||||0.0036|TWO_SIDED|95.0|1.4|7.5||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.5 mL Inflexal V vs. 0.25 mL Agrippal for the A/H1N1 strain.||7.5|1.4|0.0036
70855518|NCT02880956|141198395|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|2.97|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71121190|NCT01310400|141748263|NON_INFERIORITY_OR_EQUIVALENCE|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|-3.0||||0.1465|TWO_SIDED|95.0|-7.0|1.0||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.25 mL Inflexal V vs. 0.25 mL Agrippal for the A/H1N1 strain.||1.0|-7.0|0.1465
71121191|NCT01310400|141748263|NON_INFERIORITY_OR_EQUIVALENCE|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|8.0|||<|0.001|TWO_SIDED|95.0|3.3|12.7||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.5 mL Inflexal V vs. 0.25 mL Agrippal for the A/H3N2 strain.||12.7|3.3|<0.001
71082213|NCT00086450|141671725|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.4||||0.049||95.0|||||Log Rank|||||||0.049
71082214|NCT00086450|141671726|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||Regression, Cox|||||||0.68
71082215|NCT02497404|141671744|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the survival proportion.|Proportion (percent)|46.2|||||TWO_SIDED|95.0|30.1|62.8||||||||62.8|30.1|
71082216|NCT02497404|141671745|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the survival proportion.|Proportion (percent)|64.1|||||TWO_SIDED|95.0|47.2|78.8||||||||78.8|47.2|
71082217|NCT02497404|141671746|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the survival proportion.|Proportion (percent)|33.3|||||TWO_SIDED|95.0|19.1|50.2||||||||50.2|19.1|
71082218|NCT02497404|141671747|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the survival proportion.|Proportion (percent)|89.7|||||TWO_SIDED|95.0|75.8|97.1||||||||97.1|75.8|
71082219|NCT02497404|141671748|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the survival proportion.|Proportion (percent)|64.1|||||TWO_SIDED|95.0|47.2|78.8||||||||78.8|47.2|
71082220|NCT02497404|141671749|OTHER||Proportion (percent)|38.5|||||TWO_SIDED|95.0|23.4|55.4||||||Clopper-Pearson (exact) 95% confidence interval provided for the survival proportion.||55.4|23.4|
71082221|NCT02497404|141671750|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the graft failure proportion.|Proportion (percent)|2.6|||||TWO_SIDED|95.0|0.07|13.5||||||||13.5|0.07|
71082222|NCT02497404|141671751|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the GVHD proportion.|Proportion (percent)|33.3|||||TWO_SIDED|95.0|19.1|50.2||||||||50.2|19.1|
71082223|NCT02497404|141671752|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the high-risk extensive chronic graft-versus-host-disease proportion.|Proportion (percent)|5.1|||||TWO_SIDED|95.0|0.63|15.3||||||||15.3|0.63|
71082224|NCT01408901|141671759|SUPERIORITY||Mean Difference (Final Values)|28.7||||0.052|TWO_SIDED|95.0|5.1|52.3||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||52.3|5.1|0.052
71082225|NCT01408901|141671759|SUPERIORITY||Mean Difference (Final Values)|-6.3||||0.91|TWO_SIDED|95.0|-30.2|17.6||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||17.6|-30.2|0.91
71082226|NCT01408901|141671759|SUPERIORITY||Mean Difference (Final Values)|-1.4||||0.91|TWO_SIDED|95.0|-25.2|22.4||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||22.4|-25.2|0.91
71082227|NCT01408901|141671759|SUPERIORITY||Mean Difference (Final Values)|33.6||||0.02|TWO_SIDED|95.0|9.4|57.7||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||57.7|9.4|0.02
71082228|NCT01408901|141671760|SUPERIORITY||Hodges-Lehmann estimator|-0.61||||0.49|TWO_SIDED|95.0|-1.67|0.44||The P value is a Hochberg-adjusted P value.|Wilcoxon (Mann-Whitney)|||||0.44|-1.67|0.49
71082229|NCT01408901|141671760|SUPERIORITY||Hodges-Lehmann estimator|-0.67||||0.49|TWO_SIDED|95.0|-1.84|0.51||The P value is a Hochberg-adjusted P value.|Wilcoxon (Mann-Whitney)|||||0.51|-1.84|0.49
71082230|NCT01408901|141671760|SUPERIORITY||Hodges-Lehmann estimator|0.36||||0.49|TWO_SIDED|95.0|-0.66|1.38||The P value is a Hochberg-adjusted P value.|Wilcoxon (Mann-Whitney)|||||1.38|-0.66|0.49
71082231|NCT01408901|141671760|SUPERIORITY||Hodges-Lehmann estimator|0.48||||0.49|TWO_SIDED|95.0|-0.64|1.59||The P value is a Hochberg-adjusted P value.|Wilcoxon (Mann-Whitney)|||||1.59|-0.64|0.49
71082232|NCT01408901|141671761|SUPERIORITY||Mean Difference (Final Values)|3.6|||<|0.01|TWO_SIDED|95.0|2.1|5.0||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||5.0|2.1|<0.01
71082233|NCT01408901|141671761|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.44|TWO_SIDED|95.0|-2.1|0.8||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||0.8|-2.1|0.44
71082234|NCT01408901|141671761|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.44|TWO_SIDED|95.0|-2.1|0.9||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||0.9|-2.1|0.44
71082235|NCT01408901|141671761|SUPERIORITY||Mean Difference (Final Values)|3.7|||<|0.01|TWO_SIDED|95.0|2.2|5.2||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||5.2|2.2|<0.01
71082236|NCT01408901|141671762|SUPERIORITY||Mean Difference (Final Values)|-0.006||||0.09|TWO_SIDED|95.0|-0.012|0.001|||t-test, 2 sided|||||0.001|-0.012|0.09
71082237|NCT01408901|141671763|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.03|TWO_SIDED|95.0|-0.01|-0.001|||t-test, 2 sided|||||-0.001|-0.010|0.03
71082238|NCT01408901|141671764|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.09|TWO_SIDED|95.0|-0.012|0.001|||t-test, 2 sided|||||0.001|-0.012|0.09
71082239|NCT01408901|141671765|SUPERIORITY||Mean Difference (Final Values)|-0.004||||0.17|TWO_SIDED|95.0|-0.009|0.002|||t-test, 2 sided|||||0.002|-0.009|0.17
71082240|NCT04550364|141671769|OTHER|Semi-structured interview, background information, DSM 5 diagnosis and ED symptoms.||||||||||||||||23 of 24 women were used ideal type analysis as the methods. EDE-Q and DSM 5 diagnosis were measured.|Ideal type analysis as main method of analysis|||
71082241|NCT04550364|141671770|OTHER|Interpretative phenomenological analysis (IPA)||||||||||||||||of the 24 mothers there were 7 of them that had undergone In vitro fertilization. These women were interviewed twice and IPA were used in analysis the material.|IPA|||
71082242|NCT04550364|141671771|OTHER|Grounded theory was used analysis method. 5 distinct ED trajectories into motherhood were identified based on the womens experiences from pregnancy to postpartum.||||||||||||||||This study was based on interviews conducted with 24 participants during pregnancy and postpartum. Semi-structured interview with 24 women at two time points: 1. During pregnancy and 2. 4-6 months after birth. DSM 5 diagnosis at both time points were also assessed and symptoms at eating disorders through EDE-Q.|Qualitative methods using Ground theory|||
71082243|NCT05464420|141671802|OTHER|Estimated difference in percentage and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|6.0|||||TWO_SIDED|95.0|3.0|8.6||||||Injection site erythema: V116 Combined Lots - PPSV23||8.6|3.0|
71082244|NCT05464420|141671802|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|12.6|||||TWO_SIDED|95.0|8.0|17.3||||||Injection site pain: V116 Combined Lots - PPSV23||17.3|8.0|
71082245|NCT05464420|141671802|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|5.6|||||TWO_SIDED|95.0|2.6|8.2||||||Injection site swelling: V116 Combined Lots - PPSV23||8.2|2.6|
71082246|NCT05464420|141671804|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|1.4|||||TWO_SIDED|95.0|-3.2|6.0||||||Fatigue: V116 Combined Lots - PPSV23||6.0|-3.2|
71082247|NCT05464420|141671804|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|5.8|||||TWO_SIDED|95.0|1.6|9.7||||||Headache: V116 Combined Lots - PPSV23||9.7|1.6|
71082248|NCT05464420|141671804|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|7.6|||||TWO_SIDED|95.0|4.5|10.5||||||Myalgia: V116 Combined Lots - PPSV23||10.5|4.5|
71082249|NCT05464420|141671804|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|0.8|||||TWO_SIDED|95.0|-1.0|2.1||||||Pyrexia: V116 Combined Lots - PPSV23||2.1|-1.0|
71121192|NCT01310400|141748263|NON_INFERIORITY_OR_EQUIVALENCE|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|0.9||||0.7493|TWO_SIDED|95.0|-4.5|6.2||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.25 mL Inflexal V vs. 0.25 mL Agrippal for the A/H3N2 strain.||6.2|-4.5|0.7493
71121193|NCT01310400|141748263|NON_INFERIORITY_OR_EQUIVALENCE|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|20.2||||0|TWO_SIDED|95.0|13.5|27.0||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.5 mL Inflexal V vs. 0.25 mL Agrippal for the B-strain.||27.0|13.5|0.0000
71082250|NCT05464420|141671806|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|0.0|||||TWO_SIDED|95.0|-0.7|0.2||||||Vaccine-related SAEs: V116 Combined Lots - PPSV23||0.2|-0.7|
71082251|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.96|1.24||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 3: GMT Ratio V116 Lot 1/ V116 Lot 2||1.24|0.96|<0.001
71082252|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.9|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/ V116 Lot 3|Serotype 3: GMT Ratio V116 Lot 1/ V116 Lot 3||1.17|0.90|<0.001
71082253|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.83|1.06||Identical p-values for the lower and upper bounds.|cLDA Model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/ V116 Lot 3|Serotype 3: GMT Ratio V116 Lot 2/ V116 Lot 3||1.06|0.83|<0.001
71082254|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.15|||<|0.001|TWO_SIDED|95.0|0.97|1.35||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 6A: GMT Ratio V116 Lot 1/ V116 Lot 2||1.35|0.97|<0.001
71082255|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.88|1.22||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 6A: GMT Ratio V116 Lot 1/ V116 Lot 3||1.22|0.88|<0.001
71082256|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.91|||<|0.001|TWO_SIDED|95.0|0.77|1.06||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 6A: GMT Ratio V116 Lot 2/ V116 Lot 3||1.06|0.77|<0.001
71082257|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.16|||<|0.001|TWO_SIDED|95.0|1.01|1.34||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 7F: V116 Lot 1/ V116 Lot 2||1.34|1.01|<0.001
70855519|NCT02880956|141198395|SUPERIORITY||LS Mean of Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.335||0.009|TWO_SIDED|95.0|-1.537|-0.22||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||-0.220|-1.537|0.009
70855520|NCT02880956|141198395|SUPERIORITY||Effect size/pooled SD|-0.31|STANDARD_DEVIATION|2.87|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71082258|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.94|1.25||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 7F: GMT Ratio V116 Lot 1/ V116 Lot 3||1.25|0.94|<0.001
71121194|NCT01310400|141748263|NON_INFERIORITY_OR_EQUIVALENCE|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|10.7||||0.0029|TWO_SIDED|95.0|3.7|17.6||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.25 mL Inflexal V vs. 0.25 mL Agrippal for the B-strain.||17.6|3.7|0.0029
71082259|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.93|||<|0.001|TWO_SIDED|95.0|0.81|1.07||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 7F: GMT Ratio V116 Lot 2/ V116 Lot 3||1.07|0.81|<0.001
71082260|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.92|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 8 V116 Lot 1/V116 Lot 2||1.16|0.92|<0.001
71082261|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.93|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/ V116 Lot 3|Serotype 8: GMT Ratio V116 Lot 1/ V116 Lot 3||1.18|0.93|<0.001
71082262|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.9|1.14||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/ V116 Lot 3|Serotype 8: GMT Ratio V116 Lot 2/ V116 Lot 3||1.14|0.90|<0.001
71082263|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.94|1.26||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 9N: GMT Ratio V116 Lot 1/ V116 Lot 2||1.26|0.94|<0.001
71082264|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.87|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 9N: GMT Ratio V116 Lot 1/ V116 Lot 3||1.17|0.87|<0.001
71082265|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.93|||<|0.001|TWO_SIDED|95.0|0.8|1.07||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 9N: GMT Ratio V116 Lot 2/V116 Lot 3||1.07|0.80|<0.001
71082266|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.85|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 10A: GMT Ratio V116 Lot 1/ V116 Lot 2||1.11|0.85|<0.001
71082267|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.91|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 10A: GMT Ratio V116 Lot 1/ V116 Lot 3||1.18|0.91|<0.001
71082268|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.06|||<|0.001|TWO_SIDED|95.0|0.93|1.21||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 10A: GMT Ratio V116 Lot 2/V116 Lot 3||1.21|0.93|<0.001
71082269|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.84|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 11A: GMT Ratio V116 Lot 1/ V116 Lot 2||1.11|0.84|<0.001
71082270|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.87|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 11A: GMT Ratio V116 Lot 1/V116 Lot 3||1.16|0.87|<0.001
71082271|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.9|1.2||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 11A: GMT Ratio V116 Lot 2/V116 Lot 3||1.20|0.90|<0.001
71082272|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.1|||<|0.001|TWO_SIDED|95.0|0.96|1.26||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 12F: GMT Ratio V116 Lot 1/V116 Lot 2||1.26|0.96|<0.001
71082273|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.89|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 12F: GMT Ratio V116 Lot 1/V116 Lot 3||1.17|0.89|<0.001
71082274|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.93|||<|0.001|TWO_SIDED|95.0|0.81|1.07||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 12F: GMT Ratio V116 Lot 2/V116 Lot 3||1.07|0.81|<0.001
71082275|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.89|1.22||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 15A: GMT Ratio V116 Lot 1/V116 Lot 2||1.22|0.89|<0.001
71082276|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.86|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 15A: GMT Ratio V116 Lot 1/V116 Lot 3||1.17|0.86|<0.001
71082277|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.82|1.12||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 15A: GMT Ratio V116 Lot 2/V116 Lot 3||1.12|0.82|<0.001
71082278|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.15|||<|0.001|TWO_SIDED|95.0|0.95|1.38||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 15C: GMT Ratio V116 Lot 1/V116 Lot 2||1.38|0.95|<0.001
71082279|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.18|||<|0.001|TWO_SIDED|95.0|0.97|1.42||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 15C: GMT Ratio V116 Lot 1/V116 Lot 3||1.42|0.97|<0.001
71082280|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.85|1.23||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 15C: GMT Ratio V116 Lot 2/V116 Lot 3||1.23|0.85|<0.001
71082281|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.84|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 16F: GMT Ratio V116 Lot 1/V116 Lot 2||1.11|0.84|<0.001
71082282|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.84|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 16F: GMT Ratio V116 Lot 1/V116 Lot 3||1.11|0.84|<0.001
71082283|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.87|1.15||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 16F: GMT Ratio V116 Lot 2/V116 Lot 3||1.15|0.87|<0.001
71082284|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.85|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 17F: GMT Ratio V116 Lot 1/V116 Lot 2||1.11|0.85|<0.001
71082285|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.89|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 17F: GMT Ratio V116 Lot 1/V116 Lot 3||1.17|0.89|<0.001
71082286|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.92|1.2||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 17F: GMT Ratio V116 Lot 2/V116 Lot 3||1.20|0.92|<0.001
71082287|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.91|1.15||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 19A: GMT Ratio V116 Lot 1/V116 Lot 2||1.15|0.91|<0.001
71082288|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.95|||<|0.001|TWO_SIDED|95.0|0.84|1.07||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 19A: GMT Ratio V116 Lot 1/V116 Lot 3||1.07|0.84|<0.001
71082289|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.93|||<|0.001|TWO_SIDED|95.0|0.82|1.04||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 19A: GMT Ratio V116 Lot 2/V116 Lot 3||1.04|0.82|<0.001
71082290|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.98|||<|0.001|TWO_SIDED|95.0|0.84|1.14||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 20A: GMT Ratio V116 Lot 1/V116 Lot 2||1.14|0.84|<0.001
71082291|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.07|||<|0.001|TWO_SIDED|95.0|0.92|1.24||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 20A: GMT Ratio V116 Lot 1/V116 Lot 3||1.24|0.92|<0.001
71082292|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.94|1.27||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 20A: GMT Ratio V116 Lot 2/V116 Lot 3||1.27|0.94|<0.001
71082293|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.1|||<|0.001|TWO_SIDED|95.0|0.93|1.29||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 22F: GMT Ratio V116 Lot 1/V116 Lot 2||1.29|0.93|<0.001
70855521|NCT02880956|141198395|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.333||0.952|TWO_SIDED|95.0|-0.674|0.634||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.634|-0.674|0.952
70855522|NCT02880956|141198395|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|3.01|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71082294|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.87|1.21||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 22F: GMT Ratio V116 Lot 1/V116 Lot 3||1.21|0.87|<0.001
71082295|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.8|1.1||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 22F: GMT Ratio V116 Lot 2/V116 Lot 3||1.10|0.80|<0.001
71082296|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.85|1.17||Identical p-values for the lower and upper bounds.|cDLA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 23A: GMT Ratio V116 Lot 1/V116 Lot 2||1.17|0.85|<0.001
71082297|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.86|1.19||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 23A: GMT Ratio V116 Lot 1/V116 Lot 3||1.19|0.86|<0.001
71082298|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.87|1.19||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 23A: GMT Ratio V116 Lot 2/V116 Lot 3||1.19|0.87|<0.001
71082299|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.22|||<|0.001|TWO_SIDED|95.0|1.0|1.48||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 23B: GMT Ratio V116 Lot 1/V116 Lot 2||1.48|1.00|<0.001
70855523|NCT02880956|141198395|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.324||0.764|TWO_SIDED|95.0|-0.54|0.734||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.734|-0.540|0.764
70855524|NCT02880956|141198395|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|2.85|||TWO_SIDED|||||||||Week 48||||
70855525|NCT02880956|141198395|SUPERIORITY||LS Mean of Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.331||0.103|TWO_SIDED|95.0|-1.191|0.109||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.109|-1.191|0.103
71082300|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.98|||<|0.001|TWO_SIDED|95.0|0.8|1.19||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 23B: GMT Ratio V116 Lot 1/V116 Lot 3||1.19|0.80|<0.001
71082301|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.8|||<|0.001|TWO_SIDED|95.0|0.66|0.97||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 23B: GMT Ratio V116 Lot 2/V116 Lot 3||0.97|0.66|<0.001
71082302|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.88|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 24F: GMT Ratio V116 Lot 1/V116 Lot 2||1.18|0.88|<0.001
71082303|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.88|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 24F: GMT Ratio V116 Lot 1/V116 Lot 3||1.18|0.88|<0.001
71082304|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.87|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 24F: GMT Ratio V116 Lot 2/V116 Lot 3||1.16|0.87|<0.001
71082305|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.87|1.2||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 31: GMT Ratio V116 Lot 1/V116 Lot 2||1.20|0.87|<0.001
71082306|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.87|1.2||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 31: GMT Ratio V116 Lot 1/V116 Lot 3||1.20|0.87|<0.001
71082307|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.85|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 31: GMT Ratio V116 Lot 2/V116 Lot 3||1.17|0.85|<0.001
70855526|NCT02880956|141198395|SUPERIORITY||Effect size/pooled SD|-0.19|STANDARD_DEVIATION|2.83|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70944284|NCT03119688|141388508|NON_INFERIORITY|The non-Inferiority margin is set at 0.25. The upper limit of the 90% CI is less than this and hence NI is met.|Mean Difference (Net)|-0.077||||0.1769|TWO_SIDED|90.0|-0.1707|0.0169||No adjustment for multiple comparisons was made.|ANOVA|ANOVA model with change from baseline in examiner assessment on dryness as response and treatment, site as fixed effects; participant as random effect|Difference is first named treatment minus second named treatment such that a negative difference favors first named treatment.|The null hypothesis (non-inferiority setting) is that the population mean dryness for Test minus Baxter Sterile Water (negative control) is at least 0.25.||0.0169|-0.1707|0.1769
70944285|NCT03119688|141388508|SUPERIORITY|This is a superiority test setting.|Mean Difference (Net)|0.35|||<|0.0001|TWO_SIDED|90.0|0.2565|0.4441||No adjustment for multiple comparisons was made.|ANOVA|ANOVA model with change from baseline in examiner assessment on dryness as response and treatment, site as fixed effects;participant as random effect|Difference is first named treatment minus second named treatment such that a negative difference favors first named treatment.|The null hypothesis is that the difference in population mean dryness is zero.||0.4441|0.2565|<.0001
71082308|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.11|||<|0.001|TWO_SIDED|95.0|0.93|1.33||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 33F: GMT Ratio V116 Lot 1/V116 Lot 2||1.33|0.93|<0.001
71082309|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.9|1.29||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 33F: GMT Ratio V116 Lot 1/V116 Lot 3||1.29|0.90|<0.001
70855527|NCT02880956|141198395|SUPERIORITY||LS Mean of Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.362||0.06|TWO_SIDED|95.0|-1.396|0.028||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.028|-1.396|0.060
71082310|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.81|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 33F: GMT Ratio V116 Lot 2/V116 Lot 3||1.16|0.81|<0.001
71082311|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.91|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 35B: GMT Ratio V116 Lot 1/V116 Lot 2||1.17|0.91|<0.001
71082312|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.91|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 35B: GMT Ratio V116 Lot 1/V116 Lot 3||1.18|0.91|<0.001
71082313|NCT05464420|141671807|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.89|1.14||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 35B: GMT Ratio V116 Lot 2/V116 Lot 3||1.14|0.89|<0.001
71082314|NCT05464420|141671808|OTHER||GMT Ratio|0.93|||||TWO_SIDED|95.0|0.84|1.03|||||V116 Combined Lots/PPSV23|Serotype 3: GMT Ratio V116 Combined Lots/ PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.03|0.84|
71082315|NCT05464420|141671808|OTHER||GMT Ratio|3.48|||||TWO_SIDED|95.0|3.01|4.02|||||V116 Combined Lots/PPSV23|Serotype 6A: GMT Ratio V116 Combined Lots/ PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|4.02|3.01|
71082316|NCT05464420|141671808|OTHER||GMT Ratio|1.33|||||TWO_SIDED|95.0|1.18|1.49|||||V116 Combined Lots/PPSV23|Serotype 7F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.49|1.18|
71082317|NCT05464420|141671808|OTHER||GMT Ratio|0.85|||||TWO_SIDED|95.0|0.77|0.93|||||V116 Combined Lots/PPSV23|Serotype 8: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|0.93|0.77|
71082318|NCT05464420|141671808|OTHER||GMT Ratio|0.95|||||TWO_SIDED|95.0|0.85|1.08|||||V116 Combined Lots/PPSV23|Serotype 9N: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.08|0.85|
71082319|NCT05464420|141671808|OTHER||GMT Ratio|1.32|||||TWO_SIDED|95.0|1.18|1.48|||||V116 Combined Lots/PPSV23|Serotype 10A: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.48|1.18|
71082320|NCT05464420|141671808|OTHER||GMT Ratio|1.74|||||TWO_SIDED|95.0|1.56|1.95|||||V116 Combined Lots/PPSV23|Serotype 11A: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.95|1.56|
71082321|NCT05464420|141671808|OTHER||GMT Ratio|1.38|||||TWO_SIDED|95.0|1.22|1.56|||||V116 Combined Lots/PPSV23|Serotype 12F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.56|1.22|
71082322|NCT05464420|141671808|OTHER||GMT Ratio|4.03|||||TWO_SIDED|95.0|3.56|4.56|||||V116 Combined Lots/PPSV23|Serotype 15A: GMT Ratio v116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|4.56|3.56|
71082323|NCT05464420|141671808|OTHER||GMT Ratio|2.9|||||TWO_SIDED|95.0|2.49|3.38|||||V116 Combined Lots/PPSV23|Serotype 15C: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|3.38|2.49|
71082324|NCT05464420|141671808|OTHER||GMT Ratio|3.72|||||TWO_SIDED|95.0|3.32|4.17||||||Serotype 16F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|4.17|3.32|
71082325|NCT05464420|141671808|OTHER||GMT Ratio|1.71|||||TWO_SIDED|95.0|1.53|1.91|||||V116 Combined Lots/PPSV23|Serotype 17F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.91|1.53|
71082326|NCT05464420|141671808|OTHER||GMT Ratio|0.93|||||TWO_SIDED|95.0|0.84|1.03|||||V116 Combined Lots/PPSV23|Serotype 19A: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.03|0.84|
71082327|NCT05464420|141671808|OTHER||GMT Ratio|1.47|||||TWO_SIDED|95.0|1.3|1.67|||||V116 Combined Lots/PPSV23|Serotype 20A: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.67|1.30|
71082328|NCT05464420|141671808|OTHER||GMT Ratio|1.34|||||TWO_SIDED|95.0|1.17|1.53|||||V116 Combined Lots/PPSV23|Serotype 22F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.53|1.17|
71082329|NCT05464420|141671808|OTHER||GMT Ratio|7.98|||||TWO_SIDED|95.0|6.84|9.31|||||V116 Combined Lots/PPSV23|Serotype 23A: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|9.31|6.84|
71082330|NCT05464420|141671808|OTHER||GMT Ratio|23.72|||||TWO_SIDED|95.0|19.71|28.55|||||V116 Combined Lots/PPSV23|Serotype 23B: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|28.55|19.71|
71082331|NCT05464420|141671808|OTHER||GMT Ratio|19.55|||||TWO_SIDED|95.0|16.7|22.88|||||V116 Combined Lots/PPSV23|Serotype 24F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|22.88|16.70|
71082332|NCT05464420|141671808|OTHER||GMT Ratio|13.55|||||TWO_SIDED|95.0|11.68|15.71|||||V116 Combined Lots/PPSV23|Serotype 31: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|15.71|11.68|
71082333|NCT05464420|141671808|OTHER||GMT Ratio|0.84|||||TWO_SIDED|95.0|0.73|0.97||||||Serotype 33F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|0.97|0.73|
71082334|NCT05464420|141671808|OTHER||GMT Ratio|3.71|||||TWO_SIDED|95.0|3.36|4.09|||||V116 Combined Lots/PPSV23|Serotype 35B: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|4.09|3.36|
71082335|NCT05464420|141671809|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.88|1.09|||||V116 Lot 1/V116 Lot 2|Serotype 3: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.09|0.88|
71082336|NCT05464420|141671809|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.85|1.05|||||V116 Lot 1/V116 Lot 3|Serotype 3: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.05|0.85|
71082337|NCT05464420|141671809|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.87|1.08|||||V116 Lot 2/V116 Lot 3|Serotype 3: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.08|0.87|
71082338|NCT05464420|141671809|OTHER||GMC Ratio|1.12|||||TWO_SIDED|95.0|0.95|1.32|||||V116 Lot 1/V116 Lot 2|Serotype 6A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.32|0.95|
71082339|NCT05464420|141671809|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.86|1.2|||||V116 Lot 1/V116 Lot 3|Serotype 6A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.20|0.86|
71082340|NCT05464420|141671809|OTHER||GMC Ratio|0.91|||||TWO_SIDED|95.0|0.77|1.07|||||V116 Lot 2/V116 Lot 3|Serotype 6A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.07|0.77|
71082341|NCT05464420|141671809|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.11|||||V116 Lot 1/V116 Lot 2|Serotype 7F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.11|0.85|
70855528|NCT02880956|141198395|SUPERIORITY||Effect size/pooled SD|-0.22|STANDARD_DEVIATION|3.09|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71082342|NCT05464420|141671809|OTHER||GMC Ratio|1.03|||||TWO_SIDED|95.0|0.9|1.18|||||V116 Lot 1/V116 Lot 3|Serotype 7F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.18|0.90|
71082343|NCT05464420|141671809|OTHER||GMC Ratio|1.06|||||TWO_SIDED|95.0|0.93|1.21|||||V116 Lot 2/V116 Lot 3|Serotype 7F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.21|0.93|
71082344|NCT05464420|141671809|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.86|1.12|||||V116 Lot 1/V116 Lot 2|Serotype 8: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.12|0.86|
70855529|NCT02880956|141198395|SUPERIORITY||LS Mean of Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.36||0.091|TWO_SIDED|95.0|-1.316|0.098||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.098|-1.316|0.091
70855530|NCT02880956|141198395|SUPERIORITY||Effect size/pooled SD|-0.2|STANDARD_DEVIATION|3.03|||TWO_SIDED|||||||||Week 72||||
70855531|NCT02880956|141198395|SUPERIORITY||LS Mean of Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.361||0.12|TWO_SIDED|95.0|-1.274|0.147||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.147|-1.274|0.120
70855532|NCT02880956|141198395|SUPERIORITY||Effect size/pooled SD|-0.19|STANDARD_DEVIATION|2.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855533|NCT02880956|141198395|SUPERIORITY||LS Mean of Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.395||0.429|TWO_SIDED|95.0|-1.09|0.464||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.464|-1.090|0.429
70855534|NCT02880956|141198395|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|3.13|||TWO_SIDED|||||||||Week 96||||
70855535|NCT02880956|141198395|SUPERIORITY||LS Mean of Difference|0.21|STANDARD_ERROR_OF_MEAN|0.389||0.597|TWO_SIDED|95.0|-0.559|0.97||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.970|-0.559|0.597
70855536|NCT02880956|141198395|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|2.98|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855537|NCT02880956|141198395|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.4||0.86|TWO_SIDED|95.0|-0.717|0.858||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.858|-0.717|0.860
70855538|NCT02880956|141198395|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|3.22|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855539|NCT02880956|141198396|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.497||0.854|TWO_SIDED|95.0|-1.069|0.885||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.885|-1.069|0.854
70855540|NCT02880956|141198396|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|4.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855541|NCT02880956|141198396|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.491||0.412|TWO_SIDED|95.0|-1.368|0.562||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.562|-1.368|0.412
70944286|NCT03119688|141388508|SUPERIORITY|This is a superiority test setting.|Mean Difference (Net)|0.427|||<|0.0001|TWO_SIDED|90.0|0.3333|0.5211||No adjustment for multiple comparisons was made.|ANOVA|ANOVA model with change from baseline in examiner assessment on dryness as response and treatment, site as fixed effects; participant as random effect|Difference is first named treatment minus second named treatment such that a negative difference favors first named treatment.|The null hypothesis is that the difference in population mean dryness is zero.||0.5211|0.3333|<.0001
70855542|NCT02880956|141198396|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|4.08|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855543|NCT02880956|141198396|SUPERIORITY||LS Mean of Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.503||0.262|TWO_SIDED|95.0|-1.554|0.424||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.424|-1.554|0.262
70855544|NCT02880956|141198396|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|3.82|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71082345|NCT05464420|141671809|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.87|1.13|||||V116 Lot 1/V116 Lot 3|Serotype 8: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.13|0.87|
71082346|NCT05464420|141671809|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.89|1.15|||||V116 Lot 2/V116 Lot 3|Serotype 8: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.15|0.89|
71082347|NCT05464420|141671809|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.91|1.21|||||V116 Lot 1/V116 Lot 2|Serotype 9N: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.21|0.91|
71082348|NCT05464420|141671809|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.77|1.03|||||V116 Lot 1/V116 Lot 3|Serotype 9N: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.03|0.77|
70855545|NCT02880956|141198396|SUPERIORITY||LS Mean of Difference|0.91|STANDARD_ERROR_OF_MEAN|0.571||0.11|TWO_SIDED|95.0|-0.209|2.036||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.036|-0.209|0.110
70855546|NCT02880956|141198396|SUPERIORITY||Effect size/pooled SD|0.22|STANDARD_DEVIATION|4.09|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855547|NCT02880956|141198396|SUPERIORITY||LS Mean of Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.555||0.263|TWO_SIDED|95.0|-1.713|0.469||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.469|-1.713|0.263
70855548|NCT02880956|141198396|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|4.21|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855549|NCT02880956|141198396|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.57||0.868|TWO_SIDED|95.0|-1.026|1.217||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.217|-1.026|0.868
70855550|NCT02880956|141198396|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|3.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71082349|NCT05464420|141671809|OTHER||GMC Ratio|0.85|||||TWO_SIDED|95.0|0.74|0.98|||||V116 Lot 2/V116 Lot 3|Serotype 9N: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|0.98|0.74|
71082350|NCT05464420|141671809|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.87|1.18|||||V116 Lot 1/V116 Lot 2|Serotype 10A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.18|0.87|
70855551|NCT02880956|141198396|SUPERIORITY||LS Mean of Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.592||0.82|TWO_SIDED|95.0|-1.298|1.029||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.029|-1.298|0.820
70855552|NCT02880956|141198396|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|4.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71082351|NCT05464420|141671809|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.83|1.13|||||V116 Lot 1/V116 Lot 3|Serotype 10A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.13|0.83|
71082352|NCT05464420|141671809|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.82|1.11|||||V116 Lot 2/V116 Lot 3|Serotype 10A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.11|0.82|
71082353|NCT05464420|141671809|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.9|1.14|||||V116 Lot 1/V116 Lot 2|Serotype 11A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.14|0.90|
71082354|NCT05464420|141671809|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.91|1.15|||||V116 Lot 1/V116 Lot 3|Serotype 11A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.15|0.91|
71082355|NCT05464420|141671809|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.9|1.14|||||V116 Lot 2/V116 Lot 3|Serotype 11A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.14|0.90|
71082356|NCT05464420|141671809|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.8|1.12|||||V116 Lot 1/V116 Lot 2|Serotype 12F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.12|0.80|
70855553|NCT02880956|141198396|SUPERIORITY||LS Mean of Difference|0.16|STANDARD_ERROR_OF_MEAN|0.583||0.781|TWO_SIDED|95.0|-0.984|1.308||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.308|-0.984|0.781
71082357|NCT05464420|141671809|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.84|1.18|||||V116 Lot 1/V116 Lot 3|Serotype 12F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.18|0.84|
71082358|NCT05464420|141671809|OTHER||GMC Ratio|1.06|||||TWO_SIDED|95.0|0.89|1.25|||||V116 Lot 2/V116 Lot 3|Serotype 12F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.25|0.89|
71082359|NCT05464420|141671809|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.91|1.21|||||V116 Lot 1/V116 Lot 2|Serotype 15A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.21|0.91|
71082360|NCT05464420|141671809|OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.83|1.11|||||V116 Lot 1/V116 Lot 3|Serotype 15A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.11|0.83|
71082361|NCT05464420|141671809|OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.8|1.05|||||V116 Lot 2/V116 Lot 3|Serotype 15A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.05|0.80|
71082362|NCT05464420|141671809|OTHER||GMC Ratio|1.06|||||TWO_SIDED|95.0|0.91|1.23|||||V116 Lot 1/V116 Lot 2|Serotype 15C: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.23|0.91|
71082363|NCT05464420|141671809|OTHER||GMC Ratio|1.03|||||TWO_SIDED|95.0|0.89|1.2|||||V116 Lot 1/V116 Lot 3|Serotype 15C: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.20|0.89|
71082364|NCT05464420|141671809|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.84|1.14|||||V116 Lot 2/V116 Lot 3|Serotype 15C: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.14|0.84|
71082365|NCT05464420|141671809|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.78|1.03|||||V116 Lot 1/V116 Lot 2|Serotype 16F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.03|0.78|
71082366|NCT05464420|141671809|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.78|1.04|||||V116 Lot 1/V116 Lot 3|Serotype 16F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.04|0.78|
71082367|NCT05464420|141671809|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.88|1.15|||||V116 Lot 2/V116 Lot 3|Serotype 16F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.15|0.88|
71082368|NCT05464420|141671809|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.91|1.21|||||V116 Lot 1/V116 Lot 2|Serotype 17F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.21|0.91|
71082369|NCT05464420|141671809|OTHER||GMC Ratio|1.07|||||TWO_SIDED|95.0|0.93|1.23|||||V116 Lot 1/V116 Lot 3|Serotype 17F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.23|0.93|
71082370|NCT05464420|141671809|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.88|1.17|||||V116 Lot 2/V116 Lot 3|Serotype 17F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.17|0.88|
71082371|NCT05464420|141671809|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.11|||||V116 Lot 1/V116 Lot 2|Serotype 19A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.11|0.85|
71082372|NCT05464420|141671809|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.79|1.04|||||V116 Lot 1/V116 Lot 3|Serotype 19A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.04|0.79|
71082373|NCT05464420|141671809|OTHER||GMC Ratio|0.93|||||TWO_SIDED|95.0|0.82|1.07|||||V116 Lot 2/V116 Lot 3|Serotype 19A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.07|0.82|
71082374|NCT05464420|141671809|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.83|1.1|||||V116 Lot 1/V116 Lot 2|Serotype 20A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.10|0.83|
71082375|NCT05464420|141671809|OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.84|1.1|||||V116 Lot 1/V116 Lot 3|Serotype 20A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.10|0.84|
71082376|NCT05464420|141671809|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.88|1.16|||||V116 Lot 2/V116 Lot 3|Serotype 20A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.16|0.88|
70855554|NCT02880956|141198396|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|4.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71082377|NCT05464420|141671809|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.87|1.16|||||V116 Lot 1/V116 Lot 2|Serotype 22F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.16|0.87|
71082378|NCT05464420|141671809|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.87|1.16|||||V116 Lot 1/V116 Lot 3|Serotype 22F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.16|0.87|
71082379|NCT05464420|141671809|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.86|1.15|||||V116 Lot 2/V116 Lot 3|Serotype 22F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.15|0.86|
71082380|NCT05464420|141671809|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.84|1.16|||||V116 Lot 1/V116 Lot 2|Serotype 23A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.16|0.84|
71082381|NCT05464420|141671809|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.83|1.15|||||V116 Lot 1/V116 Lot 3|Serotype 23A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.15|0.83|
71082382|NCT05464420|141671809|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.85|1.17|||||V116 Lot 2/V116 Lot 3|Serotype 23A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.17|0.85|
71082383|NCT05464420|141671809|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.87|1.18|||||V116 Lot 1/V116 Lot 2|Serotype 23B: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.18|0.87|
71082384|NCT05464420|141671809|OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.79|1.07|||||V116 Lot 1/V116 Lot 3|Serotype 23B: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.07|0.79|
71082385|NCT05464420|141671809|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.77|1.05|||||V116 Lot 2/V116 Lot 3|Serotype 23B: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.05|0.77|
71082386|NCT05464420|141671809|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.8|1.13|||||V116 Lot 1/V116 Lot 2|Serotype 24F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.13|0.80|
71082387|NCT05464420|141671809|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.84|1.19|||||V116 Lot 1/V116 Lot 3|Serotype 24F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.19|0.84|
71082388|NCT05464420|141671809|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.88|1.25|||||V116 Lot 2/V116 Lot 3|Serotype 24F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.25|0.88|
71082389|NCT05464420|141671809|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.77|1.0|||||V116 Lot 1/V116 Lot 2|Serotype 31: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.00|0.77|
71082390|NCT05464420|141671809|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.88|1.14|||||V116 Lot 1/V116 Lot 3|Serotype 31: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.14|0.88|
71082391|NCT05464420|141671809|OTHER||GMC Ratio|1.14|||||TWO_SIDED|95.0|1.0|1.3|||||V116 Lot 2/V116 Lot 3|Serotype 31: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.30|1.00|
71082392|NCT05464420|141671809|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.89|1.16|||||V116 Lot 1/V116 Lot 2|Serotype 33F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.16|0.89|
71082393|NCT05464420|141671809|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.88|1.15|||||V116 Lot 1/V116 Lot 3|Serotype 33F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.15|0.88|
71082394|NCT05464420|141671809|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.87|1.13|||||V116 Lot 2/V116 Lot 3|Serotype 33F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.13|0.87|
71082395|NCT05464420|141671809|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.9|1.17|||||V116 Lot 1/V116 Lot 2|Serotype 35B: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.17|0.90|
71082396|NCT05464420|141671809|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.87|1.13|||||V116 Lot 1/V116 Lot 3|Serotype 35B: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.13|0.87|
71082397|NCT05464420|141671809|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.1|||||V116 Lot 2/V116 Lot 3|Serotype 35B: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.10|0.85|
71082398|NCT05464420|141671810|OTHER||GMC Ratio|1.1|||||TWO_SIDED|95.0|1.01|1.21|||||V116 Combined Lots/PPSV23|Serotype 3: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.21|1.01|
71082399|NCT05464420|141671810|OTHER||GMC Ratio|3.91|||||TWO_SIDED|95.0|3.43|4.45|||||V116 Combined Lots/PPSV23|Serotype 6A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|4.45|3.43|
71082400|NCT05464420|141671810|OTHER||GMC Ratio|1.54|||||TWO_SIDED|95.0|1.38|1.72|||||V116 Combined Lots/PPSV23|Serotype 7F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.72|1.38|
71082401|NCT05464420|141671810|OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.73|0.89|||||V116 Combined Lots/PPSV23|Serotype 8: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|0.89|0.73|
70855555|NCT02880956|141198396|SUPERIORITY||LS Mean of Difference|0.08|STANDARD_ERROR_OF_MEAN|0.59||0.895|TWO_SIDED|95.0|-1.082|1.238||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.238|-1.082|0.895
71082402|NCT05464420|141671810|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.91|1.14|||||V116 Combined Lots/PPSV23|Serotype 9N: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.14|0.91|
70855556|NCT02880956|141198396|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|4.75|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71082403|NCT05464420|141671810|OTHER||GMC Ratio|1.47|||||TWO_SIDED|95.0|1.3|1.66|||||V116 Combined Lots/PPSV23|Serotype 10A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.66|1.30|
70855557|NCT02880956|141198396|SUPERIORITY||LS Mean of Difference|0.63|STANDARD_ERROR_OF_MEAN|0.69||0.359|TWO_SIDED|95.0|-0.724|1.991||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.991|-0.724|0.359
70855558|NCT02880956|141198396|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|4.55|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855559|NCT02880956|141198396|SUPERIORITY||LS Mean of Difference|0.34|STANDARD_ERROR_OF_MEAN|0.675||0.612|TWO_SIDED|95.0|-0.985|1.67||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.670|-0.985|0.612
70855560|NCT02880956|141198396|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|4.72|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855561|NCT02880956|141198396|SUPERIORITY||LS Mean of Difference|0.5|STANDARD_ERROR_OF_MEAN|0.696||0.475|TWO_SIDED|95.0|-0.872|1.867||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.867|-0.872|0.475
70855562|NCT02880956|141198396|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|4.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855563|NCT02880956|141198397|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.427||0.926|TWO_SIDED|95.0|-0.799|0.878||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.878|-0.799|0.926
70855564|NCT02880956|141198397|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|3.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71082404|NCT05464420|141671810|OTHER||GMC Ratio|1.38|||||TWO_SIDED|95.0|1.26|1.52|||||V116 Combined Lots/PPSV23|Serotype 11A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.52|1.26|
70855565|NCT02880956|141198397|SUPERIORITY||LS Mean of Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.423||0.553|TWO_SIDED|95.0|-1.082|0.58||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.580|-1.082|0.553
70855566|NCT02880956|141198397|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|3.96|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855567|NCT02880956|141198397|SUPERIORITY||LS Mean of Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.432||0.69|TWO_SIDED|95.0|-1.021|0.677||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.677|-1.021|0.690
70855568|NCT02880956|141198397|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|4.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855569|NCT02880956|141198397|SUPERIORITY||LS Mean of Difference|0.9|STANDARD_ERROR_OF_MEAN|0.499||0.073|TWO_SIDED|95.0|-0.085|1.879||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.879|-0.085|0.073
70855570|NCT02880956|141198397|SUPERIORITY||Effect size/pooled SD|0.22|STANDARD_DEVIATION|4.03|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71082405|NCT05464420|141671810|OTHER||GMC Ratio|1.41|||||TWO_SIDED|95.0|1.23|1.62|||||V116 Combined Lots/PPSV23|Serotype 12F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.62|1.23|
71082406|NCT05464420|141671810|OTHER||GMC Ratio|6.82|||||TWO_SIDED|95.0|6.08|7.65|||||V116 Combined Lots/PPSV23|Serotype 15A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|7.65|6.08|
71082407|NCT05464420|141671810|OTHER||GMC Ratio|3.24|||||TWO_SIDED|95.0|2.86|3.67|||||V116 Combined Lots/PPSV23|Serotype 15C: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|3.67|2.86|
71082408|NCT05464420|141671810|OTHER||GMC Ratio|6.48|||||TWO_SIDED|95.0|5.83|7.19|||||V116 Combined Lots/PPSV23|Serotype 16F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|7.19|5.83|
71082409|NCT05464420|141671810|OTHER||GMC Ratio|1.85|||||TWO_SIDED|95.0|1.66|2.07|||||V116 Combined Lots/PPSV23|Serotype 17F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|2.07|1.66|
71082410|NCT05464420|141671810|OTHER||GMC Ratio|1.1|||||TWO_SIDED|95.0|0.98|1.22|||||V116 Combined Lots/PPSV23|Serotype 19A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.22|0.98|
71082411|NCT05464420|141671810|OTHER||GMC Ratio|1.53|||||TWO_SIDED|95.0|1.37|1.71|||||V116 Combined Lots/PPSV23|Serotype 20A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.71|1.37|
71082412|NCT05464420|141671810|OTHER||GMC Ratio|1.32|||||TWO_SIDED|95.0|1.17|1.49|||||V116 Combined Lots/PPSV23|Serotype 22F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.49|1.17|
71082413|NCT05464420|141671810|OTHER||GMC Ratio|8.14|||||TWO_SIDED|95.0|7.19|9.23|||||V116 Combined Lots/PPSV23|Serotype 23A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|9.23|7.19|
71082414|NCT05464420|141671810|OTHER||GMC Ratio|5.74|||||TWO_SIDED|95.0|5.08|6.48|||||V116 Combined Lots/PPSV23|Serotype 23B: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|6.48|5.08|
71082415|NCT05464420|141671810|OTHER||GMC Ratio|14.47|||||TWO_SIDED|95.0|12.77|16.4|||||V116 Combined Lots/PPSV23|Serotype 24F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|16.40|12.77|
70855571|NCT02880956|141198397|SUPERIORITY||LS Mean of Difference|0.32|STANDARD_ERROR_OF_MEAN|0.487||0.517|TWO_SIDED|95.0|-0.641|1.273||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|repeated measures model|||Week 48||1.273|-0.641|0.517
71082416|NCT05464420|141671810|OTHER||GMC Ratio|9.55|||||TWO_SIDED|95.0|8.61|10.59|||||V116 Combined Lots/PPSV23|Serotype 31: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|10.59|8.61|
71082417|NCT05464420|141671810|OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.73|0.91|||||V116 Combined Lots/PPSV23|Serotype 33F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|0.91|0.73|
71082418|NCT05464420|141671810|OTHER||GMC Ratio|7.06|||||TWO_SIDED|95.0|6.41|7.77|||||V116 Combined Lots/PPSV23|Serotype 35B: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|7.77|6.41|
71082419|NCT02497937|141671870|OTHER||Mean Difference (Net)|0.793|||||TWO_SIDED|95.0|-0.925|2.512|||||Difference estimate of DLco on Day 7 has been presented for Mayo site|||2.512|-0.925|
71082420|NCT03790865|141671908|SUPERIORITY||Mean Difference (Net)|4.0|||<|0.025|TWO_SIDED||||||Mixed Models Analysis|||||||<0.025
71082421|NCT04530838|141671969|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-1.4|||||TWO_SIDED|95.0|-4.4|1.3||||||Serotype 1: 2-Sided 95% CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||1.3|-4.4|
71082422|NCT04530838|141671969|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-2.7|||||TWO_SIDED|95.0|-6.2|0.1||||||Serotype 3: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||0.1|-6.2|
71121195|NCT01062841|141748267|SUPERIORITY_OR_OTHER||Rate Ratio|0.77|||<|0.05|TWO_SIDED|95.0|0.62|0.94||The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.|Regression, Poisson|||A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.||0.94|0.62|<0.05
71121196|NCT01062841|141748268|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.54||||0.04|TWO_SIDED|95.0|0.3|0.97|||Regression, Cox|||A Cox proportional hazards model using the cluster option with robust standard errors was used to predict time to the first and recurrent infections, adjusting for participant-level and facility-level covariates.||0.97|0.30|0.04
71121197|NCT01062841|141748269|SUPERIORITY_OR_OTHER||Rate Ratio|0.78|||<|0.05|TWO_SIDED|95.0|0.64|0.96||The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.|Regression, Poisson|||A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.||0.96|0.64|<0.05
71121198|NCT01062841|141748270|SUPERIORITY_OR_OTHER||Rate Ratio|1.2|||>|0.05|TWO_SIDED|95.0|0.82|1.75||The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.|Regression, Poisson|||A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.||1.75|0.82|>0.05
71121199|NCT01062841|141748271|SUPERIORITY_OR_OTHER||Rate Ratio|0.94|||>|0.05|TWO_SIDED|95.0|0.61|1.44||The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.|Regression, Poisson|||A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.||1.44|0.61|>0.05
70855572|NCT02880956|141198397|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|4.21|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71082423|NCT04530838|141671969|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-2.3|||||TWO_SIDED|95.0|-5.6|0.5||||||Serotype 4: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||0.5|-5.6|
71082424|NCT04530838|141671969|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-5.0|||||TWO_SIDED|95.0|-9.6|-0.9||||||Serotype 5: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-0.9|-9.6|
71082425|NCT04530838|141671969|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-8.1|||||TWO_SIDED|95.0|-13.0|-4.0||||||Serotype 6A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-4.0|-13.0|
71082426|NCT04530838|141671969|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-8.6|||||TWO_SIDED|95.0|-14.0|-3.7||||||Serotype 6B: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-3.7|-14.0|
71082427|NCT04530838|141671969|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-3.2|||||TWO_SIDED|95.0|-6.8|-0.3||||||Serotype 7F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-0.3|-6.8|
71082428|NCT04530838|141671969|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-2.7|||||TWO_SIDED|95.0|-6.4|0.4||||||Serotype 9V: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||0.4|-6.4|
71121200|NCT01062841|141748272|SUPERIORITY_OR_OTHER||Rate Ratio|0.75|||<|0.05|TWO_SIDED|95.0|0.58|0.97||The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.|Regression, Poisson|||A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.||0.97|0.58|<0.05
71121201|NCT01062841|141748274|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.09||||0.92|TWO_SIDED|95.0|0.22|5.45|||Regression, Cox|||A Cox proportional hazards model using the cluster option with robust standard errors was used to predict time to the first and recurrent infections, adjusting for participant-level and facility-level covariates.||5.45|0.22|0.92
71121202|NCT01062841|141748275|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.83||||0.34|TWO_SIDED|95.0|0.53|6.31|||Regression, Cox|||A Cox proportional hazards model using the cluster option with robust standard errors was used to predict time to the first and recurrent infections, adjusting for participant-level and facility-level covariates.||6.31|0.53|0.34
71121203|NCT01062841|141748276|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.78||||0.01|TWO_SIDED|95.0|0.65|0.95|||Regression, Cox|||A Cox proportional hazards model was used to evaluate the effect of this intervention on an individual's risk of new MDRO acquisition, defined as the number of residents with new acquisitions per 1000 device-days at risk after adjusting for resident-level and facility-level covariates, as well as clustering by facility. Residents colonized with the specific MDRO at baseline were excluded from these analyses.||0.95|0.65|0.01
71121204|NCT01062841|141748277|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.85||||0.61|TWO_SIDED|95.0|0.45|1.6|||Regression, Cox|||A Cox proportional hazards model was used to evaluate the effect of this intervention on an individual's risk of new MDRO acquisition, defined as the number of residents with new acquisitions per 1000 device-days at risk after adjusting for resident-level and facility-level covariates, as well as clustering by facility. Residents colonized with the specific MDRO at baseline were excluded from these analyses.||1.60|0.45|0.61
71082429|NCT04530838|141671969|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-0.9|||||TWO_SIDED|95.0|-4.4|2.4||||||Serotype 14: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||2.4|-4.4|
71082430|NCT04530838|141671969|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-2.3|||||TWO_SIDED|95.0|-5.6|0.5||||||Serotype 18C: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||0.5|-5.6|
71082431|NCT04530838|141671969|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Serotype 19A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||2.1|-2.1|
70855573|NCT02880956|141198397|SUPERIORITY||LS Mean of Difference|0.38|STANDARD_ERROR_OF_MEAN|0.501||0.454|TWO_SIDED|95.0|-0.609|1.36||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.360|-0.609|0.454
71121205|NCT01062841|141748278|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9||||0.59|TWO_SIDED|95.0|0.6|1.33|||Regression, Cox|||||1.33|0.60|0.59
71121206|NCT01118520|141748281|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|||||||0.78
71121207|NCT01118520|141748281|SUPERIORITY|||||||0.89|||||||Mixed Models Analysis|||||||0.89
71121208|NCT01089023|141748299|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value measures the significance between each visit using analysis of variance|ANOVA|||||||<0.0001
71121209|NCT01089023|141748300|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value measures the significance between each visit using analysis of variance|ANOVA|||||||<0.0001
71121210|NCT00904618|141748302|SUPERIORITY_OR_OTHER|||||||0.0087||95.0|||||Fisher Exact|||The test applies to the number of participants improved.||||0.0087
71121211|NCT03220581|141748305|SUPERIORITY||F|9.026||||0.004|TWO_SIDED||||||ANCOVA|Baseline number of days of game play in the past week was included as a covariate.||||||.004
71121212|NCT03220581|141748306|SUPERIORITY||F|7.922||||0.007|TWO_SIDED||||||ANCOVA|Covariate = number of days of gaming in the past week at baseline, reported by the parent.||||||.007
71121213|NCT03220581|141748307|SUPERIORITY||F|3.73||||0.059|TWO_SIDED||||||ANCOVA|Controlled for number of symptoms of Internet gaming disorder at baseline - assessed through clinical interview with child||||||.059
71121214|NCT03220581|141748308|SUPERIORITY||F|2.91||||0.095|TWO_SIDED||||||ANCOVA|Controlled for baseline number of symptoms of Internet gaming disorder, assessed through clinical interview with the parent||||||.095
71082432|NCT04530838|141671969|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.7|1.7||||||Serotype 19F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.7|-1.7|
71082433|NCT04530838|141671969|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-4.0|||||TWO_SIDED|95.0|-9.5|1.2||||||Serotype 23F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.2|-9.5|
70855574|NCT02880956|141198397|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|4.45|||TWO_SIDED|||||||||Week 48||||
71121215|NCT01396265|141748309|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|66.2|STANDARD_DEVIATION|16.1|||TWO_SIDED|90.0|60.815|72.057|||ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||72.057|60.815|
70855575|NCT02880956|141198397|SUPERIORITY||LS Mean of Difference|0.57|STANDARD_ERROR_OF_MEAN|0.522||0.276|TWO_SIDED|95.0|-0.456|1.596||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.596|-0.456|0.276
71121216|NCT01396265|141748310|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|66.18|STANDARD_DEVIATION|16.5|||TWO_SIDED|90.0|60.656|72.213|||ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||72.213|60.656|
71121217|NCT01396265|141748311|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|78.41|STANDARD_DEVIATION|15.6|||TWO_SIDED|90.0|72.363|84.968|||ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||84.968|72.363|
71121218|NCT02275117|141748320|SUPERIORITY|75% Migraine Responder Rate - Week 1-12 (Modified Full Analysis Population)|Mean Difference (Final Values)|12.6||||0.033|TWO_SIDED|95.0|1.3|24.0|||Cochran-Mantel-Haenszel|||||24.0|1.3|0.0330
71121219|NCT02275117|141748320|SUPERIORITY|75% Migraine Responder Rate - Week 1-12 (Modified Full Analysis Population)|Mean Difference (Final Values)|10.7||||0.0715|TWO_SIDED|95.0|-0.5|21.8|||Cochran-Mantel-Haenszel|||||21.8|-0.5|0.0715
71121220|NCT02275117|141748320|SUPERIORITY|75% Migraine Responder Rate - Week 1-12 (Modified Full Analysis Population)|Mean Difference (Final Values)|7.5||||0.2013|TWO_SIDED|95.0|-3.5|18.5|||Cochran-Mantel-Haenszel|||||18.5|-3.5|0.2013
71121221|NCT02275117|141748320|SUPERIORITY|75% Migraine Responder Rate - Week 1-12 (Modified Full Analysis Population)|Mean Difference (Final Values)|6.1||||0.2938|TWO_SIDED|95.0|-4.6|16.9|||Cochran-Mantel-Haenszel|||||16.9|-4.6|0.2938
71121222|NCT02825966|141748369|EQUIVALENCE|The two one-sided t-test (TOST) was used to test equivalence. Using TOST, equivalence was established at α = 0.05 significance level if a (1-2α)\*100% confidence interval for the average difference in EMAT (WCD-AUDICOR) was contained within the interval \[-12, 12\].|Mean Difference (Final Values)|1.01|||<|0.001|TWO_SIDED|90.0|-2.89|4.69|||two one-sided test (TOST)|||First, the difference in EMAT between the LifeVest and AUDICOR device (first wear) was calculated for each subject. Then the mean and standard deviation of the differences in EMAT were calculated. The 2 devices were considered equivalent if the 90% confidence interval for mean difference in EMAT was within the pre-specified margin of \[-12, 12\] ms.||4.69|-2.89|< 0.001
71121223|NCT00681564|141748370|SUPERIORITY_OR_OTHER|||||||0.98||||||A P value of 0.05 was used as a cut-off for statistical significance.|Kruskal-Wallis|Non-parametric test appropriate for the analysis of non-normally distributed data.||Analyzed variable: Brachial Artery Flow-mediated Dilation (baseline). Note: data analysis of patients who completed the study protocol (n=86). Intention-to-treat analysis analysis was not used because its application for the evaluation of continuous data would imply imputing missing data for patients lost to follow-up. Mean and standard deviation of flow-mediated dilatation, including data from all patients randomized in this study, is reported in the field of baseline characteristics.||||0.98
71121224|NCT00681564|141748370|SUPERIORITY_OR_OTHER|||||||0.005||||||A P value of 0.05 was used as a cut-off for statistical significance.|Kruskal-Wallis|Non-parametric test appropriate for the analysis of non-normally distributed data.||Analyzed variable: Brachial Artery Flow-mediated Dilation (24 hours).||||0.005
71082434|NCT04530838|141671969|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|5.9|||||TWO_SIDED|95.0|3.0|10.0||||||Serotype 8: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||10.0|3.0|
71082435|NCT04530838|141671969|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|-33.5|||||TWO_SIDED|95.0|-40.7|-26.2||||||Serotype 10A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-26.2|-40.7|
71082436|NCT04530838|141671969|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|6.4|||||TWO_SIDED|95.0|3.8|10.4||||||Serotype 11A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||10.4|3.8|
71082437|NCT04530838|141671969|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|-19.0|||||TWO_SIDED|95.0|-25.7|-12.5||||||Serotype 12F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-12.5|-25.7|
71082438|NCT04530838|141671969|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|5.5|||||TWO_SIDED|95.0|2.2|9.6||||||Serotype 15B: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||9.6|2.2|
71082439|NCT04530838|141671969|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|6.4|||||TWO_SIDED|95.0|3.8|10.4||||||Serotype 22F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||10.4|3.8|
71121225|NCT00681564|141748370|SUPERIORITY_OR_OTHER|||||||0.43||||||A P value of 0.05 was used as a cut-off for statistical significance.|Kruskal-Wallis|Non-parametric test appropriate for the analysis of non-normally distributed data.||"Statistical analysis: Brachial Artery Flow-mediated Dilation (12 weeks). Intention-to-treat analysis was not used because input of values for patients lost at follow-up will artificially amplify the precision of outcome measures.~Higgins JPT, Deeks JJ, Altman DG (editors). Chapter 16: Special topics in statistics. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions. Version 5.0.1. The Cochrane Collaboration, 2008. www.cochrane-handbook.org."||||0.43
71121226|NCT00432744|141748471|SUPERIORITY_OR_OTHER||Kendall's Tau B|0.015|STANDARD_ERROR_OF_MEAN|0.23||0.95|TWO_SIDED|95.0|-0.44|0.48||Two-sided Test|Wilcoxon (Mann-Whitney)||Positive value of Tau-B would favor CoQ.|Study intended to accrue 40 subjects, but only obtained 14 evaluable on this endpoint.||0.48|-0.44|0.95
71121227|NCT00432744|141748472|SUPERIORITY_OR_OTHER||Kendall's Tau B|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.18|TWO_SIDED|95.0|-0.12|0.72|||Wilcoxon (Mann-Whitney)||A positive value would favor CoQ.|Study intended to accrue 40 subjects, but only obtained 14 evaluable on this endpoint.||0.72|-0.12|0.18
71121228|NCT00432744|141748473|SUPERIORITY_OR_OTHER|||||||0.42||||||The Hotelling T-sq=1.74 and 42% of the rerandomizations to groups of 7 and 8 had Hotelling T-sq of at least 1.74. This is the standard method for permutation tests. The large sample null is chi-sq with 2 df, which has a mean=2.|Non-parametric Hotelling T-square|||The actual study was powered to have 40 participants but only 24 participated and of these only 15 had outcome data.||||0.42
71121229|NCT00892606|141748475|SUPERIORITY|||||||0.0072|||||||ANOVA|||||||0.0072
71121230|NCT00892606|141748476|SUPERIORITY|||||||0.004|||||||ANOVA|||||||0.004
71121231|NCT00892606|141748477|SUPERIORITY|||||||0.0146|||||||ANOVA|||||||0.0146
70855576|NCT02880956|141198397|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|3.94|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71082440|NCT04530838|141671969|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|1.3|||||TWO_SIDED|95.0|-3.2|6.0||||||Serotype 33F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||6.0|-3.2|
71082441|NCT04530838|141671969|OTHER||Percentage Difference|-5.7|||||TWO_SIDED|95.0|-10.4|-1.7||||||Serotype 1: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-1.7|-10.4|
71082442|NCT04530838|141671969|OTHER||Percentage Difference|-1.1|||||TWO_SIDED|95.0|-5.2|2.9||||||Serotype 3: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||2.9|-5.2|
71082443|NCT04530838|141671969|OTHER||Percentage Difference|-2.0|||||TWO_SIDED|95.0|-6.2|1.9||||||Serotype 4: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.9|-6.2|
70944287|NCT03119688|141388508|SUPERIORITY|This is a superiority test setting.|Mean Difference (Net)|0.065||||0.2518|TWO_SIDED|90.0|-0.0287|0.1592||No adjustment for multiple comparisons was made.|ANOVA|ANOVA model with change from baseline in examiner assessment on dryness as response and treatment, site as fixed effects;participant as random effect|Difference is first named treatment minus second named treatment such that a negative difference favors first named treatment.|The null hypothesis is that the difference in population mean dryness is zero.||0.1592|-0.0287|0.2518
70944288|NCT03226106|141388514|SUPERIORITY||Mean Difference (Final Values)|930.51||||0.024|TWO_SIDED|95.0|41.65|1819.36||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||1819.36|41.65|0.024
71082444|NCT04530838|141671969|OTHER||Percentage Difference|0.7|||||TWO_SIDED|95.0|-4.5|5.8||||||Serotype 5: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||5.8|-4.5|
71082445|NCT04530838|141671969|OTHER||Percentage Difference|4.8|||||TWO_SIDED|95.0|-0.2|10.0||||||Serotype 6A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||10.0|-0.2|
71082446|NCT04530838|141671969|OTHER||Percentage Difference|-5.6|||||TWO_SIDED|95.0|-12.5|1.1||||||Serotype 6B: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.1|-12.5|
71121232|NCT03840525|141748494|EQUIVALENCE|To estimate precision, 95%CI will be calculated using Wilson's score method, which uses asymptotic variance and is appropriate for small sample sizes100. The formula is as follows: (2np + z2 ± √(z2 + 4npq)) / 2(n+ z2). If the proportion of participants who rate the intervention as acceptable is 80% or greater, we will consider the intervention acceptable.|||||||||||||||||Descriptive statistics were conducted. No group comparisons were done due to the fact that this was a feasibility trial and not an efficacy trial. 80% was used as the benchmark for acceptability.|||
71121233|NCT03840525|141748495|EQUIVALENCE|To estimate precision, 95%CI will be calculated using Wilson's score method, which uses asymptotic variance and is appropriate for small sample sizes100. The formula is as follows: (2np + z2 ± √(z2 + 4npq)) / 2(n+ z2). If the proportion of participants who rate the intervention as acceptable is 80% or greater, we will consider the intervention acceptable.|||||||||||||||||Descriptive statistics was conducted to determine acceptability for both the qigong and sham qigong group. No between group comparisons were conducted. A benchmark of 80% was used to determine acceptability.|||
71121234|NCT03840525|141748496|EQUIVALENCE|To estimate precision, 95%CI will be calculated using Wilson's score method, which uses asymptotic variance and is appropriate for small sample sizes100. The formula is as follows: (2np + z2 ± √(z2 + 4npq)) / 2(n+ z2). If the proportion of participants who rate the intervention as acceptable is 80% or greater, we will consider the intervention acceptable.|||||||||||||||||Descriptive statistics were conducted to determine acceptability. Benchmark for acceptability was set at 80% of participant attending at least 70% of the classes.|||
71121235|NCT01370837|141748519|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||Kruskal-Wallis|||Arm||||0.84
71121236|NCT01370837|141748519|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Kruskal-Wallis|||Foot||||0.76
71121237|NCT01370837|141748519|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||Kruskal-Wallis|||Arm||||0.53
71121238|NCT01370837|141748519|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Kruskal-Wallis|||Foot||||0.07
71121239|NCT01370837|141748519|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Arm vs foot||||0.25
71121240|NCT01370837|141748519|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Arm vs foot||||0.27
71121241|NCT01370837|141748519|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Arm vs foot||||< 0.01
71121242|NCT04240093|141748520|SUPERIORITY|This is a pilot intervention trial and was not powered to detect statistical significance.|Beta coefficient|-0.46|STANDARD_ERROR_OF_MEAN|0.33||0.17|TWO_SIDED|95.0|-1.11|0.2||a priori alpha p\<0.05|Generalized estimating equations (GEE)|Generalized estimating equations (GEE) with a poisson distribution controlling for baseline values.||Hypothesis: The CoMBAT intervention arm would be superior to the Standard of Care control arm with regard to reductions in missed medication doses in the past 30 days at follow-up.||0.20|-1.11|0.17
71121243|NCT04240093|141748521|SUPERIORITY|This pilot feasibility and acceptability study was not powered to detect a statistically significant effect.|Beta coefficient|-0.18|STANDARD_ERROR_OF_MEAN|1.48||0.9|TWO_SIDED|95.0|-3.09|2.72||a priori alpha p\<0.05|Generalized estimating equation (GEE)|Generalized estimating equations (GEE) with a Poisson distribution controlling for baseline values.||Hypothesis: The CoMBAT intervention arm would be superior to the Standard of Care control arm with regard to reductions in missed medication-related visits in the past 30 days at follow-up.||2.72|-3.09|0.90
71121244|NCT04240093|141748522|SUPERIORITY|As a pilot feasibility and acceptability trial, this study was not powered to detect a statistically significant effect.|Beta coefficient|-4.71|STANDARD_ERROR_OF_MEAN|2.05||0.02|TWO_SIDED|95.0|-8.72|-0.7||A priori alpha p\<0.05|Generalized estimating equations (GEE)|Generalized estimating equation (GEE) modeling with a binomial distribution, controlling for baseline values.||Hypothesis: Fewer participants in the CoMBAT experimental arm will have a positive opioid toxicology screen at the 6-month follow-up compared to participants in the SOC control arm.||-0.70|-8.72|0.02
71121245|NCT02839902|141748526|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|-17.147||||0.0004|TWO_SIDED|95.0|-26.344|-7.95|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with cholesterol concentration in sd LDL fraction at Week 8 using an ANCOVA model.||-7.950|-26.344|0.0004
71082447|NCT04530838|141671969|OTHER||Percentage Difference|-1.1|||||TWO_SIDED|95.0|-5.4|3.1||||||Serotype 7F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||3.1|-5.4|
71082448|NCT04530838|141671969|OTHER||Percentage Difference|-3.0|||||TWO_SIDED|95.0|-7.7|1.4||||||Serotype 9V: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.4|-7.7|
71082449|NCT04530838|141671969|OTHER||Percentage Difference|-0.6|||||TWO_SIDED|95.0|-4.4|3.2||||||Serotype 14: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||3.2|-4.4|
71082450|NCT04530838|141671969|OTHER||Percentage Difference|-2.0|||||TWO_SIDED|95.0|-6.2|1.9||||||Serotype 18C: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.9|-6.2|
71082451|NCT04530838|141671969|OTHER||Percentage Difference|-0.5|||||TWO_SIDED|95.0|-3.0|1.7||||||Serotype 19A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.7|-3.0|
71082452|NCT04530838|141671969|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.8|1.7||||||Serotype 19F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.7|-1.8|
71082453|NCT04530838|141671969|OTHER||Percentage Difference|-0.9|||||TWO_SIDED|95.0|-6.9|5.1||||||Serotype 23F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||5.1|-6.9|
71121246|NCT02839902|141748526|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|-9.774||||0.1141|TWO_SIDED|95.0|-21.986|2.439|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with triglycerides concentration in sd LDL fraction at Week 8 using an ANCOVA model.||2.439|-21.986|0.1141
71121247|NCT02839902|141748526|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|-10.246||||0.0248|TWO_SIDED|95.0|-19.143|-1.349|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with free cholesterol concentration in sd LDL fraction at Week 8 using an ANCOVA model.||-1.349|-19.143|0.0248
71121248|NCT02839902|141748526|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|-11.511||||0.0047|TWO_SIDED|95.0|-19.34|-3.682|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with phospholipid concentration in sd LDL fraction at Week 8 using an ANCOVA model.||-3.682|-19.340|0.0047
71121249|NCT02839902|141748527|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|9.499||||0.1826|TWO_SIDED|95.0|-4.623|23.622|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with TG to cholesterol ratio in sd LDL fraction at Week 8 using an ANCOVA model.||23.622|-4.623|0.1826
71121250|NCT02839902|141748528|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|1.066||||0.004|TWO_SIDED|95.0|0.356|1.776|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with particle size (nm) of LDL at Week 8 monitored by cholesterol using an ANCOVA model.||1.776|0.356|0.0040
71121251|NCT02839902|141748528|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|1.553||||0.4428|TWO_SIDED|95.0|-2.884|5.991|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with particle size (nm) of LDL at Week 8 monitored by triglycerides using an ANCOVA model.||5.991|-2.884|0.4428
71082454|NCT04530838|141671969|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|-2.2|2.1||||||Serotype 8: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||2.1|-2.2|
71082455|NCT04530838|141671969|OTHER||Percentage Difference|-0.6|||||TWO_SIDED|95.0|-9.8|8.6||||||Serotype 10A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||8.6|-9.8|
71082456|NCT04530838|141671969|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.8|1.7||||||Serotype 11A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.7|-1.8|
71082457|NCT04530838|141671969|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|-8.2|8.2||||||Serotype 12F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||8.2|-8.2|
71082458|NCT04530838|141671969|OTHER||Percentage Difference|-0.5|||||TWO_SIDED|95.0|-3.3|2.0||||||Serotype 15B: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||2.0|-3.3|
71121252|NCT02839902|141748528|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|0.76||||0.057|TWO_SIDED|95.0|-0.024|1.544|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with particle size (nm) of LDL at Week 8 monitored by free cholesterol using an ANCOVA model.||1.544|-0.024|0.0570
71121253|NCT02839902|141748528|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|0.838||||0.036|TWO_SIDED|95.0|0.057|1.62|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with particle size (nm) of LDL at Week 8 monitored by phospholipid using an ANCOVA model.||1.620|0.057|0.0360
71082459|NCT04530838|141671969|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.8|1.7||||||Serotype 22F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.7|-1.8|
71082460|NCT04530838|141671969|OTHER||Percentage Difference|-2.5|||||TWO_SIDED|95.0|-7.5|2.2||||||Serotype 33F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||2.2|-7.5|
71082461|NCT04530838|141671970|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.62|||||TWO_SIDED|95.0|0.54|0.72||||||Serotype 1: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.72|0.54|
71082462|NCT04530838|141671970|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.71|||||TWO_SIDED|95.0|0.63|0.81||||||Serotype 3: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.81|0.63|
71082463|NCT04530838|141671970|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.6|||||TWO_SIDED|95.0|0.51|0.7||||||Serotype 4: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.70|0.51|
71082464|NCT04530838|141671970|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.59|||||TWO_SIDED|95.0|0.49|0.71||||||Serotype 5: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.71|0.49|
71082465|NCT04530838|141671970|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.59|||||TWO_SIDED|95.0|0.5|0.7||||||Serotype 6A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.70|0.50|
71082466|NCT04530838|141671970|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.51|||||TWO_SIDED|95.0|0.4|0.64||||||Serotype 6B: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.64|0.40|
71082467|NCT04530838|141671970|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.72|||||TWO_SIDED|95.0|0.62|0.84||||||Serotype 7F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.84|0.62|
71082468|NCT04530838|141671970|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.69|||||TWO_SIDED|95.0|0.6|0.8||||||Serotype 9V: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.80|0.60|
70855577|NCT02880956|141198397|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.516||0.935|TWO_SIDED|95.0|-0.973|1.058||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.058|-0.973|0.935
70855578|NCT02880956|141198397|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|4.35|||TWO_SIDED|95.0|||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855579|NCT02880956|141198397|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.523||0.942|TWO_SIDED|95.0|-0.99|1.066||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.066|-0.990|0.942
70855580|NCT02880956|141198397|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|4.35|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855581|NCT02880956|141198397|SUPERIORITY||LS Mean of Difference|0.32|STANDARD_ERROR_OF_MEAN|0.569||0.578|TWO_SIDED|95.0|-0.802|1.436||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.436|-0.802|0.578
70855582|NCT02880956|141198397|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|3.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855583|NCT02880956|141198397|SUPERIORITY||LS Mean of Difference|0.56|STANDARD_ERROR_OF_MEAN|0.34||0.545|TWO_SIDED|95.0|-0.762|1.441||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|repeated measures model|||Week 96||1.441|-0.762|0.545
70855584|NCT02880956|141198397|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|3.94|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855585|NCT02880956|141198397|SUPERIORITY||LS Mean of Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.583||0.346|TWO_SIDED|95.0|-1.697|0.597||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.597|-1.697|0.346
71082469|NCT04530838|141671970|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.84|||||TWO_SIDED|95.0|0.7|1.01||||||Serotype 14: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.01|0.70|
71121254|NCT00740714|141748548|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.59|STANDARD_ERROR_OF_MEAN|0.85|>|0.025|TWO_SIDED|97.5|-1.33|2.51||The primary analysis compares each active treatment arm to the placebo arm. P-values for efficacy outcomes will be 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|||ANCOVA is used with the change in total UPDRS of Coenzyme Q10 1200 mg/day arm compared to placebo group.||2.51|-1.33|>0.025
70855586|NCT02880956|141198397|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|3.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855587|NCT02880956|141198398|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.146||0.202|TWO_SIDED|95.0|-0.473|0.1||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.100|-0.473|0.202
70855588|NCT02880956|141198398|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|1.26|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855589|NCT02880956|141198398|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.144||0.76|TWO_SIDED|95.0|-0.327|0.239||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.239|-0.327|0.760
70855590|NCT02880956|141198398|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.15|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855591|NCT02880956|141198398|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.147||0.419|TWO_SIDED|95.0|-0.409|0.17||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.170|-0.409|0.419
71121255|NCT00740714|141748548|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.09|STANDARD_ERROR_OF_MEAN|0.86|>|0.025|TWO_SIDED|95.0|-0.85|3.03||The primary analysis compares each active treatment arm to the placebo arm. P-values for efficacy outcomes will be 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|||ANCOVA is used with the change in total UPDRS of Coenzyme Q10 2400 mg/day arm compared to placebo group.||3.03|-0.85|>0.025
70855592|NCT02880956|141198398|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|1.03|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70944289|NCT03226106|141388515|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.584|TWO_SIDED|95.0|-0.67|2.07||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||2.07|-0.67|0.584
71121256|NCT00740714|141748549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.84||0.7943|TWO_SIDED|97.5|-2.12|1.68||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on Modified Schwab \& England will be analyzed using ANCOVA in the same way as for the primary outcome variable.||1.68|-2.12|0.7943
71121257|NCT00740714|141748549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.87|STANDARD_ERROR_OF_MEAN|0.85||0.306||95.0|-2.79|1.04||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month on Modified Schwab \& England will be analyzed using ANCOVA in the same way as for the primary outcome variable.||1.04|-2.79|0.306
71121258|NCT00740714|141748550|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.06|<|0.1615|TWO_SIDED|97.5|-0.25|0.06||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on Modified Rankin Scale will be analyzed using ANCOVA in the same way as for the primary outcome variable.||0.06|-0.25|<0.1615
71121259|NCT00740714|141748550|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.7627|TWO_SIDED|95.0|-0.17|0.13||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-Adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plats and ITT.||Change from Baseline Visit to 16-month visit on Modified Rankin will be analyzed using ANCOVA in the same way as for the primary outcome variable.||0.13|-0.17|0.7627
71121260|NCT00740714|141748551|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6383|STANDARD_ERROR_OF_MEAN|1.18||0.6383|TWO_SIDED|97.5|-2.1|3.21||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on PD Quality of Life Scale will be analyzed using ANCOVA in the same way as for the primary outcome variable.||3.21|-2.10|0.6383
71121261|NCT00740714|141748551|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|1.19||0.667|TWO_SIDED|95.0|-3.2|2.17||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on PD Quality of Life Scale will be analyzed using ANCOVA in the same way as for the primary outcome variable.||2.17|-3.20|0.667
71121262|NCT00740714|141748552|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.49|STANDARD_ERROR_OF_MEAN|1.14||0.671|TWO_SIDED|97.5|-2.09|3.06||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on Symbol Digit Modalities Test will be analyzed using ANCOVA in the same way as for the primary outcome variable.||3.06|-2.09|0.671
71121263|NCT00740714|141748552|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74|STANDARD_ERROR_OF_MEAN|1.16||0.671|TWO_SIDED|95.0|-3.34|1.87||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on Symbol Digit Modalities Test will be analyzed using ANCOVA in the same way as for the primary outcome variable||1.87|-3.34|0.671
71121264|NCT00740714|141748553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.04||0.3445|TWO_SIDED|97.5|-0.04|0.13||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on Hoehn \& Yahr Score will be analyzed using ANCOVA in the same way as for the primary outcome variable.||0.13|-0.04|0.3445
71121265|NCT00740714|141748553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.05||0.239||95.0|-0.04|0.14||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided. with a Bonferroni-adjustd significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assess with scatter and residual plots and ITT.||Change from Baseline visit to 16-month visit on Hoehn \& Yahr will be analyzed using ANCOVA in the same way as for the primary outcome variable.||0.14|-0.04|.239
71082470|NCT04530838|141671970|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.66|||||TWO_SIDED|95.0|0.57|0.77||||||Serotype 18C: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.77|0.57|
71082471|NCT04530838|141671970|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.76|||||TWO_SIDED|95.0|0.65|0.87||||||Serotype 19A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.87|0.65|
71082472|NCT04530838|141671970|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.75|||||TWO_SIDED|95.0|0.67|0.85||||||Serotype 19F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.85|0.67|
71082473|NCT04530838|141671970|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.64|||||TWO_SIDED|95.0|0.53|0.78||||||Serotype 23F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.78|0.53|
71082474|NCT04530838|141671970|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|4.01|||||TWO_SIDED|95.0|3.36|4.79||||||Serotype 8: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||4.79|3.36|
71082475|NCT04530838|141671970|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.6|||||TWO_SIDED|95.0|0.48|0.76||||||Serotype 10A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.76|0.48|
71082476|NCT04530838|141671970|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|6.8|||||TWO_SIDED|95.0|5.69|8.13||||||Serotype 11A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||8.13|5.69|
71121266|NCT00740714|141748554|SUPERIORITY_OR_OTHER||Slope|0.536|STANDARD_ERROR_OF_MEAN|0.282||0.0577|TWO_SIDED|95.0|-0.018|1.091|||ANOVA|The ANOVA is using UPDRS worsening as outcome, Change of CoQ10 level as predictor, adjusting for site and baseline UPDRS score.||The analysis will be using the actual change of plasma levels of CoQ10(from final visit to baseline) as predictors of UPDRS worsening. Correlation of UPDRS worsening with plasma levels of CoQ10 will be calculated for all treatment groups.||1.091|-0.018|0.0577
71121267|NCT00740714|141748554|SUPERIORITY_OR_OTHER||Slope|0.245|STANDARD_ERROR_OF_MEAN|0.451||0.5889|TWO_SIDED|95.0|-0.647|1.136|||ANOVA|The ANOVA is using UPDRS worsening as outcome, Change of CoQ10 level as predictor, adjusting for site and baseline UPDRS score.||The analysis will be using the actual change of plasma levels of CoQ10(from final to baseline) as predictors of UPDRS worsening. Correlation of UPDRS worsening with plasma levels of CoQ10 will be calculated for the treatment group of Coenzyme Q10 2400 mg/day.||1.136|-0.647|0.5889
71121268|NCT00740714|141748554|SUPERIORITY_OR_OTHER||Slope|0.631|STANDARD_ERROR_OF_MEAN|0.608||0.3006|TWO_SIDED|95.0|-0.569|1.831|||ANOVA|The ANOVA is using UPDRS worsening as outcome, Change of CoQ10 level as predictor, adjusting for site and baseline UPDRS score.||The analysis will be using the actual change of plasma levels of CoQ10(from final to baseline) as predictors of UPDRS worsening. Correlation of UPDRS worsening with plasma levels of CoQ10 will be calculated for the treatment group of Coenzyme Q10 1200 mg/day.||1.831|-0.569|0.3006
71082477|NCT04530838|141671970|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.95|||||TWO_SIDED|95.0|0.76|1.2||||||Serotype 12F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.20|0.76|
71082478|NCT04530838|141671970|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|8.18|||||TWO_SIDED|95.0|6.75|9.92||||||Serotype 15B: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||9.92|6.75|
71121269|NCT00740714|141748554|SUPERIORITY_OR_OTHER||Slope|2.126|STANDARD_ERROR_OF_MEAN|1.269||0.096|TWO_SIDED|95.0|-0.382|4.633|||ANOVA|The ANOVA is using UPDRS worsening as outcome, Change of CoQ10 level as predictor, adjusting for site and baseline UPDRS score.||The analysis will be using the actual change of plasma levels of CoQ10(from final to baseline) as predictors of UPDRS worsening. Correlation of UPDRS worsening with plasma levels of CoQ10 will be calculated for the placebo group.||4.633|-0.382|0.096
70855593|NCT02880956|141198398|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.173||0.893|TWO_SIDED|95.0|-0.363|0.317||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.317|-0.363|0.893
71082479|NCT04530838|141671970|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|5.97|||||TWO_SIDED|95.0|5.0|7.12||||||Serotype 22F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||7.12|5.00|
71082480|NCT04530838|141671970|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|2.06|||||TWO_SIDED|95.0|1.69|2.51||||||Serotype 33F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||2.51|1.69|
71082481|NCT04530838|141671970|OTHER||GMR|0.85|||||TWO_SIDED|95.0|0.73|0.99||||||Serotype 1: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.99|0.73|
71082482|NCT04530838|141671970|OTHER||GMR|0.85|||||TWO_SIDED|95.0|0.74|0.98||||||Serotype 3: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.98|0.74|
71082483|NCT04530838|141671970|OTHER||GMR|0.98|||||TWO_SIDED|95.0|0.83|1.16||||||Serotype 4: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.16|0.83|
71082484|NCT04530838|141671970|OTHER||GMR|0.98|||||TWO_SIDED|95.0|0.81|1.19||||||Serotype 5: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.19|0.81|
71121270|NCT00740714|141748555|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26|STANDARD_ERROR_OF_MEAN|0.0199|<|0.05|TWO_SIDED|95.0|0.57|2.8|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||2.80|0.57|<0.05
71121271|NCT00740714|141748556|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49|STANDARD_ERROR_OF_MEAN|0.0198|<|0.05|TWO_SIDED|95.0|0.62|3.57|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subject experiencing a particular adverse experience||3.57|0.62|<0.05
71121272|NCT00740714|141748557|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65|STANDARD_ERROR_OF_MEAN|0.0198|<|0.05|TWO_SIDED|95.0|0.65|4.2|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||4.20|0.65|<0.05
70855594|NCT02880956|141198398|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|1.26|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|||||
71082485|NCT04530838|141671970|OTHER||GMR|1.19|||||TWO_SIDED|95.0|0.98|1.44||||||Serotype 6A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.44|0.98|
71082486|NCT04530838|141671970|OTHER||GMR|0.93|||||TWO_SIDED|95.0|0.72|1.21||||||Serotype 6B: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.21|0.72|
71082487|NCT04530838|141671970|OTHER||GMR|0.96|||||TWO_SIDED|95.0|0.82|1.12||||||Serotype 7F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.12|0.82|
71082488|NCT04530838|141671970|OTHER||GMR|0.99|||||TWO_SIDED|95.0|0.85|1.16||||||Serotype 9V: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.16|0.85|
71082489|NCT04530838|141671970|OTHER||GMR|0.87|||||TWO_SIDED|95.0|0.72|1.04||||||Serotype 14: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.04|0.72|
71082490|NCT04530838|141671970|OTHER||GMR|0.92|||||TWO_SIDED|95.0|0.79|1.07||||||Serotype 18C: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.07|0.79|
71082491|NCT04530838|141671970|OTHER||GMR|0.98|||||TWO_SIDED|95.0|0.84|1.13||||||Serotype 19A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.13|0.84|
71082492|NCT04530838|141671970|OTHER||GMR|0.98|||||TWO_SIDED|95.0|0.87|1.1||||||Serotype 19F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.10|0.87|
71082493|NCT04530838|141671970|OTHER||GMR|0.98|||||TWO_SIDED|95.0|0.81|1.19||||||Serotype 23F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.19|0.81|
71082494|NCT04530838|141671970|OTHER||GMR|0.99|||||TWO_SIDED|95.0|0.87|1.13||||||Serotype 8: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.13|0.87|
71121273|NCT00740714|141748558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91|STANDARD_ERROR_OF_MEAN|0.02|<|0.05|TWO_SIDED|95.0|0.46|1.79|||ANCOVA||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||1.79|0.46|<0.05
71121274|NCT00740714|141748559|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5|STANDARD_ERROR_OF_MEAN|0.0199|<|0.05|TWO_SIDED|95.0|0.66|3.41|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||3.41|0.66|<0.05
71121275|NCT00740714|141748560|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.8|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.81|9.72|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||9.72|0.81|<0.05
71121276|NCT00740714|141748561|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.31|1.52|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||1.52|0.31|<0.05
71121277|NCT00740714|141748562|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.36|1.7|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||1.70|0.36|<0.05
71121278|NCT00740714|141748563|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.44|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.69|8.58|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||8.58|0.69|<0.05
71121279|NCT00740714|141748564|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.31|1.62|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||1.62|0.31|<0.05
71121280|NCT00740714|141748565|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9999.98|STANDARD_ERROR_OF_MEAN|0.0196|<|0.05|TWO_SIDED|95.0|2.77|9999.99|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||9999.99|2.77|<0.05
71121281|NCT00740714|141748566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.25|1.12|||Fisher Exact||Odds ration \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||1.12|0.25|<0.05
71121282|NCT00740714|141748567|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.26|STANDARD_ERROR_OF_MEAN|0.0196|<|0.05|TWO_SIDED|95.0|0.64|8.01|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||8.01|0.64|<0.05
71121283|NCT00740714|141748568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33|STANDARD_ERROR_OF_MEAN|0.0198|<|0.05|TWO_SIDED|95.0|0.55|3.24|||Fisher Exact||Odds ratio of \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||3.24|0.55|<0.05
70855595|NCT02880956|141198398|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.168||0.886|TWO_SIDED|95.0|-0.306|0.354||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.354|-0.306|0.886
70855596|NCT02880956|141198398|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|1.46|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855597|NCT02880956|141198398|SUPERIORITY||LS Mean of Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.172||0.306|TWO_SIDED|95.0|-0.515|0.162||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.162|-0.515|0.306
70855598|NCT02880956|141198398|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|1.12|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855599|NCT02880956|141198398|SUPERIORITY||LS Mean of Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.116||0.008|TWO_SIDED|95.0|-0.535|-0.079||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||-0.079|-0.535|0.008
70855600|NCT02880956|141198398|SUPERIORITY||Effect size/pooled SD|-0.26|STANDARD_DEVIATION|1.2|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855601|NCT02880956|141198398|SUPERIORITY||LS Mean of Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.115||0.031|TWO_SIDED|95.0|-0.474|-0.023||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||-0.023|-0.474|0.031
70855602|NCT02880956|141198398|SUPERIORITY||Effect size/pooled SD|-0.21|STANDARD_DEVIATION|1.16|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855603|NCT02880956|141198398|SUPERIORITY||LS Mean of Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.116||0.014|TWO_SIDED|95.0|-0.514|-0.059||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||-0.059|-0.514|0.014
70855604|NCT02880956|141198398|SUPERIORITY||Effect size/pooled SD|-0.25|STANDARD_DEVIATION|1.15|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|||||
70855605|NCT02880956|141198398|SUPERIORITY||LS Mean of Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.135||0.065|TWO_SIDED|95.0|-0.514|0.016||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.016|-0.514|0.065
70855606|NCT02880956|141198398|SUPERIORITY||Effect size/pooled SD|-0.21|STANDARD_DEVIATION|1.17|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855607|NCT02880956|141198398|SUPERIORITY||LS Mean of Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.132||0.121|TWO_SIDED|95.0|-0.465|0.055||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.055|-0.465|0.121
70855608|NCT02880956|141198398|SUPERIORITY||Effect size/pooled SD|1.05|STANDARD_DEVIATION|1.17|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855609|NCT02880956|141198398|SUPERIORITY||LS Mean of Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.136||0.21|TWO_SIDED|95.0|-0.438|0.097||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.097|-0.438|0.210
70855610|NCT02880956|141198398|SUPERIORITY||Effect size/pooled SD|-0.17|STANDARD_DEVIATION|1.0|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71082495|NCT04530838|141671970|OTHER||GMR|0.94|||||TWO_SIDED|95.0|0.73|1.2||||||Serotype 10A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.20|0.73|
71082496|NCT04530838|141671970|OTHER||GMR|0.93|||||TWO_SIDED|95.0|0.81|1.06||||||Serotype 11A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.06|0.81|
71082497|NCT04530838|141671970|OTHER||GMR|0.91|||||TWO_SIDED|95.0|0.71|1.15||||||Serotype 12F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.15|0.71|
71082498|NCT04530838|141671970|OTHER||GMR|1.0|||||TWO_SIDED|95.0|0.85|1.18||||||Serotype 15B: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.18|0.85|
71082499|NCT04530838|141671970|OTHER||GMR|0.89|||||TWO_SIDED|95.0|0.78|1.02||||||Serotype 22F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.02|0.78|
71082500|NCT04530838|141671970|OTHER||GMR|0.95|||||TWO_SIDED|95.0|0.79|1.15||||||Serotype 33F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.15|0.79|
71082501|NCT00803712|141671977|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Hypothesis to be tested: the proportion of participants achieving the specified PTH target of ≥ 30% reduction in PTH from baseline will be greater in the cinacalcet plus low dose active vitamin D group than in the control group during the efficacy assessment phase at month 6 (weeks 22 to 26).||||<0.0001
71121284|NCT00740714|141748569|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9999.98|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.48|9999.99|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||9999.99|0.48|<0.05
71121285|NCT00740714|141748570|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9999.98|STANDARD_ERROR_OF_MEAN|0.0196|<|0.05|TWO_SIDED|95.0|2.51|9999.99|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||9999.99|2.51|<0.05
71121286|NCT03688555|141748571|SUPERIORITY||LS means difference|0.76|STANDARD_ERROR_OF_MEAN|0.301|=|0.062|TWO_SIDED|95.0|-0.06|1.59||All Nasal Polyp Score (NPS) values observed between baseline and Week 12 were included in the analysis. Changes from baseline to post-baseline visits in NPS were analyzed using a Mixed Model for Repeated Measurement (MMRM).|Mixed model for repeated measurements|||||1.59|-0.06|= 0.062
71121287|NCT03688555|141748572|SUPERIORITY||LS means difference|-3.98|STANDARD_ERROR_OF_MEAN|2.316|=|0.161|TWO_SIDED|95.0|-10.41|2.45|||ANCOVA|||||2.45|-10.41|= 0.161
71121288|NCT01294462|141748609|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.54|||||TWO_SIDED|95.0|0.94|2.53||No P-value provided since the objective was not to perform formal statistical comparison.|Regression, Cox|Analyzed based on proportional hazards model including treatment group only.|Ticagrelor/Placebo|No formal statistical comparison.||2.53|0.94|
71121289|NCT01294462|141748610|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.47|||||TWO_SIDED|95.0|0.88|2.44||No P-value provided since the objective was not to perform formal statistical comparison.|Regression, Cox|Analyzed based on proportional hazards model including treatment group only.|Ticagrelor/Placebo|No formal statistical comparison based on hypothesis test.||2.44|0.88|
71121290|NCT01294462|141748611|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.72|||||TWO_SIDED|95.0|1.23|2.4||No P-value provided since the objective was not to perform formal statistical comparison.|Regression, Cox|Analyzed based on proportional hazards model including treatment group only.|Ticagrelor/Placebo|No formal statistical comparison.||2.40|1.23|
71121291|NCT01294462|141748612|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51|||||TWO_SIDED|95.0|0.91|2.5||No P-value provided since the objective was not to perform formal statistical comparison.|Regression, Cox|Analyzed based on proportional hazards model including treatment group only.|Ticagrelor/Placebo|No formal statistical comparison based on hypothesis test.||2.50|0.91|
70855611|NCT02880956|141198399|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.188||0.303|TWO_SIDED|95.0|-0.564|0.176||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.176|-0.564|0.303
70855612|NCT02880956|141198399|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|1.42|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855613|NCT02880956|141198399|SUPERIORITY||LS Mean of Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.186||0.358|TWO_SIDED|95.0|-0.536|0.194||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.194|-0.536|0.358
70855614|NCT02880956|141198399|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855615|NCT02880956|141198399|SUPERIORITY||LS Mean of Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.19||0.347|TWO_SIDED|95.0|-0.553|0.195||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.195|-0.553|0.347
70855616|NCT02880956|141198399|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|1.21|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71121292|NCT01400243|141748620|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||ANCOVA|||||||.05
71121293|NCT01400243|141748621|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
71121294|NCT01048866|141748628|SUPERIORITY_OR_OTHER||least-square means difference|-196.6||||0.0021|TWO_SIDED|95.0|-321.0|-72.2||The a priori threshold for statistical significance is 0.05.|ANOVA|||||-72.2|-321.0|0.0021
70855617|NCT02880956|141198399|SUPERIORITY||LS Mean of Difference|0.11|STANDARD_ERROR_OF_MEAN|0.16||0.494|TWO_SIDED|95.0|-0.205|0.423||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.423|-0.205|0.494
70855618|NCT02880956|141198399|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|1.22|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71121295|NCT01048866|141748629|SUPERIORITY_OR_OTHER||least-square means difference|-19.0||||0.0002|TWO_SIDED|95.0|-28.7|-9.3||The a priori threshold for statistical significance is 0.05.|ANOVA|Baseline DSS fitted as a covariate and centre as a fixed effect.||||-9.3|-28.7|0.0002
71121296|NCT01048866|141748630|SUPERIORITY_OR_OTHER||least-square means difference|-179.7||||0.0054|TWO_SIDED|95.0|-305.7|-53.8||The a priori threshold for statistical significance is 0.05.|ANOVA|||||-53.8|-305.7|0.0054
71121297|NCT01048866|141748631|SUPERIORITY_OR_OTHER||least-square means difference|-16.4||||0.0008|TWO_SIDED|95.0|-25.9|-7.0||The a priori threshold for statistical significance is 0.05.|ANOVA|||||-7.0|-25.9|0.0008
71121298|NCT01048866|141748632|SUPERIORITY_OR_OTHER||least-square means difference|-168.4||||0.0087|TWO_SIDED|95.0|-293.7|-43.1|||ANOVA|||||-43.1|-293.7|0.0087
71121299|NCT01048866|141748633|SUPERIORITY_OR_OTHER||least-square means difference|-19.0|||<|0.0001|TWO_SIDED|95.0|-28.0|-10.0|||ANOVA|Baseline STPIS fitted as a covariate and centre as a fixed effect.||||-10.0|-28.0|<0.0001
71121300|NCT01048866|141748634|SUPERIORITY_OR_OTHER||least-square means difference|-118.9||||0.1844|TWO_SIDED|95.0|-295.3|57.5|||ANOVA|Baseline STPIS fitted as a covariate and centre as a fixed effect.||||57.5|-295.3|0.1844
71121301|NCT01048866|141748635|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71121302|NCT01048866|141748636|SUPERIORITY_OR_OTHER|||||||0.8827|||||||Wilcoxon (Mann-Whitney)|||||||0.8827
71121303|NCT01048866|141748637|SUPERIORITY_OR_OTHER|||||||0.0105|||||||Wilcoxon (Mann-Whitney)|Stratified by centre||||||0.0105
71121304|NCT01048866|141748639|SUPERIORITY_OR_OTHER||least-square means difference|-5.9||||0.0743|TWO_SIDED|95.0|-12.4|0.6|||ANOVA|Repeated measures ANOVA model with participant as a random effect.||||0.6|-12.4|0.0743
71121305|NCT01048866|141748640|SUPERIORITY_OR_OTHER||least-square means difference|-5.5||||0.0871|TWO_SIDED|95.0|-11.7|0.8|||ANOVA|Repeated measures ANOVA model with patient as a random effect.||||0.8|-11.7|0.0871
71121306|NCT01048866|141748641|SUPERIORITY_OR_OTHER||least-square means difference|-6.0||||0.0595|TWO_SIDED|95.0|-12.3|0.2|||ANOVA|Repeated measures ANOVA model with participant as a random effect.||||0.2|-12.3|0.0595
70855619|NCT02880956|141198399|SUPERIORITY||LS Mean of Difference|0.12|STANDARD_ERROR_OF_MEAN|0.156||0.454|TWO_SIDED|95.0|-0.189|0.423||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.423|-0.189|0.454
71082502|NCT00803712|141671978|SUPERIORITY_OR_OTHER|||||||0.0002||||||Multiplicity adjusted p-value is presented, adjusted using the Dubey and Armitage-Parmer method|Cochran-Mantel-Haenszel|||||||0.0002
71121307|NCT01048866|141748642|SUPERIORITY_OR_OTHER||least-square means difference|0.5||||0.0195|TWO_SIDED|95.0|0.1|0.9|||ANOVA|Repeated measures ANOVA model with participant as a random effect.||||0.9|0.1|0.0195
71121308|NCT01048866|141748643|SUPERIORITY_OR_OTHER|||||||0.0322|||||||Regression, Logistic|Effect for centre||||||0.0322
71121309|NCT01048866|141748644|SUPERIORITY_OR_OTHER|||||||0.0276|||||||Log Rank|||||||0.0276
71121310|NCT01048866|141748645|SUPERIORITY_OR_OTHER||least-square means difference|-0.2||||0.0288|TWO_SIDED|95.0|-0.4|0.0|||ANOVA|||||-0.0|-0.4|0.0288
71121311|NCT01048866|141748646|SUPERIORITY_OR_OTHER||least-square means difference|-0.1||||0.4274|TWO_SIDED|95.0|-0.3|0.1|||ANOVA|||||0.1|-0.3|0.4274
71121312|NCT05320393|141748647|OTHER|This study was not powered for formal hypothesis testing; analyses were intended for interpretation purposes only. Analysis was performed using the modified Intent-to-Treat population and regardless of responder status.||||||0.0109|TWO_SIDED|95.0|||||Log Rank|||The primary effectiveness endpoint was a measure of duration of effect, described by Kaplan-Meier curves and the median times, with associated 2-sided 95% confidence intervals for each treatment group.||||0.0109
71082503|NCT00803712|141671979|SUPERIORITY_OR_OTHER|||||||0.0139||||||Adjusted p-value is presented. P-value is adjusted using Dubey and Armitage-Parmer method of adjusting for multiple comparisons|Cochran-Mantel-Haenszel|||||||0.0139
71082504|NCT00803712|141671980|SUPERIORITY_OR_OTHER|||||||0.2386||||||Multiplicity adjusted p-value is presented, adjusted using the Dubey and Armitage-Parmer method|Cochran-Mantel-Haenszel|||||||0.2386
71082505|NCT00803712|141671981|SUPERIORITY_OR_OTHER|||||||0.0875|||||||Cochran-Mantel-Haenszel|||||||0.0875
70855620|NCT02880956|141198399|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|1.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71082506|NCT00803712|141671982|SUPERIORITY_OR_OTHER|||||||0.4304|||||||Cochran-Mantel-Haenszel|||||||0.4304
71082507|NCT00803712|141671983|SUPERIORITY_OR_OTHER|||||||0.091|||||||Cochran-Mantel-Haenszel|||||||0.0910
71082508|NCT00803712|141671984|SUPERIORITY_OR_OTHER|||||||0.952|||||||Cochran-Mantel-Haenszel|||||||0.9520
71082509|NCT00803712|141671985|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Cochran-Mantel-Haenszel|||||||0.0003
71082510|NCT00803712|141671986|SUPERIORITY_OR_OTHER|||||||0.0611|||||||Cochran-Mantel-Haenszel|||||||0.0611
71121313|NCT05693922|141748648|SUPERIORITY|||||||0.34|||||||ANOVA|||||||0.34
71082511|NCT00803712|141671987|SUPERIORITY_OR_OTHER|||||||0.3298|||||||Cochran-Mantel-Haenszel|||||||0.3298
71082512|NCT00803712|141671988|SUPERIORITY_OR_OTHER|||||||0.4436|||||||Cochran-Mantel-Haenszel|||||||0.4436
71082513|NCT00803712|141671989|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata. Due to distributional properties of the data, analysis was performed on log-transformed data||||||<0.0001
71082514|NCT00803712|141671990|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata.||||||<0.0001
71082515|NCT00803712|141671991|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANCOVA|Analysis was adjusted for randomization strata. Due to distributional properties of the data, analysis was performed on log-transformed data||||||0.0040
71082516|NCT00803712|141671992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata.||||||<0.0001
71082517|NCT00803712|141671993|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline corrected serum calcium||||||<0.0001
71082518|NCT00803712|141671994|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline corrected serum calcium.||||||<0.0001
71082519|NCT00803712|141671995|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline corrected serum calcium.||||||<0.0001
71082520|NCT00803712|141671996|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline corrected serum calcium.||||||<0.0001
71082521|NCT00803712|141671997|SUPERIORITY_OR_OTHER|||||||0.0085|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline serum phosphorus.||||||0.0085
71082522|NCT00803712|141671998|SUPERIORITY_OR_OTHER|||||||0.071|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline serum phosphorus.||||||0.0710
71121314|NCT05693922|141748649|SUPERIORITY|||||||0.54|||||||ANOVA|||||||0.54
71121315|NCT05693922|141748650|SUPERIORITY|||||||0.865|||||||ANOVA|||||||0.865
71121316|NCT03559699|141748669|OTHER|||||||0.0002|TWO_SIDED|95.0||||1-sided P-value|Binomial exact test|||||||0.0002
71121317|NCT02091284|141748736|OTHER||||||<|0.01||||||Two-way ANOVA with repeated measures followed by Bonferroni's multiple comparisons as post-hoc test and linear regression analyses. Additional comparisons between initial and final OCDS scores were done by paired t tests for each group.|ANOVA|||||||< 0.01
71121318|NCT02091284|141748736|OTHER||||||<|0.05|||||||t-test, 2 sided|||Additional comparisons between initial and final OCDS scores were done by paired t tests for each group, and differences between final and initial scores were compared between sham-tDCS and tDCS groups with unpaired t tests.||||<0.05
71121319|NCT01460719|141748770|OTHER|The statistical criterion for significance requires that the lower bound of the 2-sided 90% confidence interval of the GMFR is \>1.0.|||||<|0.001|||||||Single longitudinal regression model|Adjustments made for pre-vaccination values||||||<0.001
71121320|NCT02838901|141748783|OTHER|This was a descriptive analysis, and was based on the overall assessment of feasibility of the intervention.||||||0.058||||||The p value is not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||The null hypothesis was used, and the assumption was there would be no difference in adherence between the Active Juice and the Placebo Juice, and therefore a two-sided t approximation was reported. Since this was a pilot study, power calculations were not performed. The adherence in the two groups was compared using the Wilcoxon two-sample test.||||0.058
71121321|NCT02838901|141748784|OTHER|This was a descriptive analysis and was under the goal of assessing safety of the intervention.||||||1|||||||Fisher Exact|||Null hypothesis was assumed, no power calculation was done since this was a pilot study.||||1.00
70855621|NCT02880956|141198399|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_DEVIATION|0.16||0.644|TWO_SIDED|95.0|-0.24|0.388||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.388|-0.240|0.644
71121322|NCT02838901|141748785|OTHER|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was assumed, and no power calculation was performed since this was a pilot study.||||0.0003
71121323|NCT02838901|141748786|OTHER|This was a descriptive analysis for a pilot study, and no power calculations were performed.||||||0.1023|||||||Wilcoxon (Mann-Whitney)|||||||0.1023
71121324|NCT02838901|141748787|OTHER|This was a descriptive analysis for a pilot study to gather preliminary data for a larger trial. No power calculations were performed for this outcome.||||||0.9581|||||||Wilcoxon (Mann-Whitney)|||||||.9581
71082523|NCT00803712|141671999|SUPERIORITY_OR_OTHER|||||||0.3546|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline serum phosphorus.||||||0.3546
71082524|NCT00803712|141672000|SUPERIORITY_OR_OTHER|||||||0.7518|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline serum phosphorus.||||||0.7518
71082525|NCT02672176|141672008|EQUIVALENCE|Information included in Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71082526|NCT02672176|141672009|EQUIVALENCE|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71082527|NCT02672176|141672010|EQUIVALENCE|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71082528|NCT02672176|141672011|EQUIVALENCE|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71082529|NCT02672176|141672012|EQUIVALENCE|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71082530|NCT02672176|141672013|EQUIVALENCE|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71082531|NCT02672176|141672014|EQUIVALENCE|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71082532|NCT02672176|141672015|EQUIVALENCE|Information in Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71082533|NCT02672176|141672016|EQUIVALENCE|Information included in Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71082534|NCT03272347|141672054|OTHER|The 95% confidence intervals (CIs) were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|2.9|||||TWO_SIDED|95.0|-12.5|18.3|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||18.3|-12.5|
71082535|NCT03272347|141672054|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|9.6|||||TWO_SIDED|95.0|-3.8|23.0|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||23.0|-3.8|
71082536|NCT03272347|141672054|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|0.2|||||TWO_SIDED|95.0|-16.0|16.3|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||16.3|-16.0|
71082537|NCT03272347|141672055|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|6.1|||||TWO_SIDED|95.0|-12.2|24.4|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||24.4|-12.2|
71082538|NCT03272347|141672055|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|6.2|||||TWO_SIDED|95.0|-12.2|24.6|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||24.6|-12.2|
71082539|NCT03272347|141672055|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|-6.1|||||TWO_SIDED|95.0|-27.1|14.8|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||14.8|-27.1|
71082540|NCT03272347|141672056|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|2.6|||||TWO_SIDED|95.0|-15.7|20.5|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||20.5|-15.7|
71082541|NCT03272347|141672056|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|2.9|||||TWO_SIDED|95.0|-15.0|20.8|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||20.8|-15.0|
71082542|NCT03272347|141672056|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|-9.7|||||TWO_SIDED|95.0|-29.4|10.1|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||10.1|-29.4|
71082543|NCT03272347|141672057|OTHER|Based on Miettinen \& Nurminen method|Difference in %|0.2|||||TWO_SIDED|95.0|-13.4|14.5|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||14.5|-13.4|
71082544|NCT03272347|141672057|OTHER|Based on Miettinen \& Nurminen method|Difference in %|-3.2|||||TWO_SIDED|95.0|-16.4|8.5|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||8.5|-16.4|
71082545|NCT03272347|141672057|OTHER|Based on Miettinen \& Nurminen method|Difference in %|3.2|||||TWO_SIDED|95.0|-10.8|18.1|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||18.1|-10.8|
71082546|NCT03272347|141672058|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|-9.7|||||TWO_SIDED|95.0|-26.1|6.6|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||6.6|-26.1|
71082547|NCT03272347|141672058|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|-6.2|||||TWO_SIDED|95.0|-21.5|9.1|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||9.1|-21.5|
71082548|NCT03272347|141672058|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|-7.5|||||TWO_SIDED|95.0|-23.9|8.8|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||8.8|-23.9|
70855622|NCT02880956|141198399|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|1.1|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855623|NCT02880956|141198399|SUPERIORITY||LS Mean of Difference|0.09|STANDARD_ERROR_OF_MEAN|0.232||0.685|TWO_SIDED|95.0|-0.363|0.551||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.551|-0.363|0.685
70855624|NCT02880956|141198399|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.64|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855625|NCT02880956|141198399|SUPERIORITY||LS Mean of Difference|0.28|STANDARD_ERROR_OF_MEAN|0.228||0.219|TWO_SIDED|95.0|-0.168|0.73||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.730|-0.168|0.219
70855626|NCT02880956|141198399|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|1.55|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855627|NCT02880956|141198399|SUPERIORITY||LS Mean of Difference|0.15|STANDARD_ERROR_OF_MEAN|0.232||0.507|TWO_SIDED|95.0|-0.302|0.61||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.610|-0.302|0.507
70855628|NCT02880956|141198399|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|1.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855629|NCT02880956|141198399|SUPERIORITY||LS Mean of Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.216||0.233|TWO_SIDED|95.0|-0.683|0.167||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.167|-0.683|0.233
70855630|NCT02880956|141198399|SUPERIORITY||Effect size/pooled SD|-0.2|STANDARD_DEVIATION|1.27|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855631|NCT02880956|141198399|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.211||0.881|TWO_SIDED|95.0|-0.383|0.446||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.446|-0.383|0.881
70855632|NCT02880956|141198399|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|1.42|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855633|NCT02880956|141198399|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.217||0.671|TWO_SIDED|95.0|-0.52|0.335||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.335|-0.520|0.671
70855634|NCT02880956|141198399|OTHER||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|1.2|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855635|NCT02880956|141198400|SUPERIORITY||LS Mean of Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.409||0.297|TWO_SIDED|95.0|-1.232|0.377||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.377|-1.232|0.297
70855636|NCT02880956|141198400|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|3.7|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855637|NCT02880956|141198400|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.405||0.979|TWO_SIDED|95.0|-0.808|0.786||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.786|-0.808|0.979
70855638|NCT02880956|141198400|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|3.63|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855639|NCT02880956|141198400|SUPERIORITY||LS Mean of Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.415||0.663|TWO_SIDED|95.0|-0.996|0.634||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.634|-0.996|0.663
70855640|NCT02880956|141198400|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|3.71|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855641|NCT02880956|141198400|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.636||0.961|TWO_SIDED|95.0|-1.22|1.282||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.282|-1.220|0.961
70855642|NCT02880956|141198400|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|4.88|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855643|NCT02880956|141198400|SUPERIORITY||LS Mean of Difference|0.13|STANDARD_ERROR_OF_MEAN|0.617||0.833|TWO_SIDED|95.0|-1.083|1.344||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.344|-1.083|0.833
71082549|NCT03272347|141672059|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|2.2|||||TWO_SIDED|95.0|-23.4|27.7|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||27.7|-23.4|
71121325|NCT02838901|141748787|OTHER|||||||0.6678|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was assumed, and no power calculation was performed since this was a pilot study and the purpose was to collect preliminary data for a larger trial.||||.6678
70855644|NCT02880956|141198400|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|5.06|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855645|NCT02880956|141198400|OTHER||LS Mean of Difference|0.23|STANDARD_ERROR_OF_MEAN|0.636||0.714|TWO_SIDED|95.0|-1.017|1.484||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.484|-1.017|0.714
70855646|NCT02880956|141198400|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|5.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71121326|NCT02838901|141748789|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
70855647|NCT02880956|141198400|SUPERIORITY||LS Mean of Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.663||0.518|TWO_SIDED|95.0|-1.733|0.876||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.876|-1.733|0.518
70855648|NCT02880956|141198400|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|5.17|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855649|NCT02880956|141198400|SUPERIORITY||LS Mean of Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.654||0.633|TWO_SIDED|95.0|-1.598|0.973||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.973|-1.598|0.633
71082550|NCT03272347|141672059|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|-3.7|||||TWO_SIDED|95.0|-29.6|22.1|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||22.1|-29.6|
71082551|NCT03272347|141672059|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|-1.3|||||TWO_SIDED|95.0|-27.7|25.2|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||25.2|-27.7|
71121327|NCT02838901|141748789|OTHER|||||||0.876|||||||Wilcoxon (Mann-Whitney)|||||||.876
71121328|NCT02838901|141748790|OTHER|||||||0.889|||||||Wilcoxon (Mann-Whitney)|||||||.889
71121329|NCT02838901|141748790|OTHER|||||||0.532|||||||Wilcoxon (Mann-Whitney)|||||||0.532
70855650|NCT02880956|141198400|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|4.9|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71121330|NCT02838901|141748791|OTHER|||||||0.888|||||||Wilcoxon (Mann-Whitney)|||||||0.888
71121331|NCT02838901|141748792|OTHER|||||||0.475|||||||Wilcoxon (Mann-Whitney)|||||||0.475
71121332|NCT02838901|141748793|OTHER|||||||0.135|||||||Wilcoxon (Mann-Whitney)|||||||0.135
71121333|NCT02838901|141748794|OTHER|||||||0.185|||||||Wilcoxon (Mann-Whitney)|||||||0.185
71121334|NCT03397134|141748819|SUPERIORITY|All statistical tests will be 2-sided hypothesis tests performed at the 5% level of significance. All confidence intervals will be 2-sided 95% confidence intervals||||||0.043||||||The p-values must be ≤0.025 to allow for rejecting the null hypothesis for the representative dose.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom.||To evaluate the efficacy of 2 fixed doses (32 mg and 64 mg) of MIN-101 compared to placebo in improving the negative symptoms of schizophrenia as measured by the change from Baseline in the PANSS Marder negative symptoms factor score (NSFS) over 12 weeks of double-blind treatment. Approximation 501 eligible patients will be randomized in a 2:2:1:1 ratio at baseline to 1 of 4 treatment arms.||||0.043
71121335|NCT03397134|141748820|SUPERIORITY|All statistical tests will be 2-sided hypothesis tests performed at the 5% level of significance. All confidence intervals will be 2-sided 95% confidence intervals.||||||0.016||||||The p-values must be ≤0.025 to allow for rejecting the null hypothesis for the representative dose.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom.||The PSP involves four subscale domains: (a) socially useful activities, (b) personal and social relationships, (c) self-care, and (d) disturbing and aggressive behaviors. After each of these four areas is scored on an anchored Likert-type scale (0-5), raters are instructed to select a 10-point range within a 100-point scale, guided by the area scores assigned during assessment.||||0.016
71082552|NCT03272347|141672061|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|78.4|||||TWO_SIDED|95.0|18.8|138.1|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||138.1|18.8|
71082553|NCT03272347|141672061|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|50.7|||||TWO_SIDED|95.0|-31.7|133.1|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||133.1|-31.7|
71082554|NCT03272347|141672061|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|0.8|||||TWO_SIDED|95.0|-63.0|64.7|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||64.7|-63.0|
71082555|NCT03272347|141672062|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|0.6|||||TWO_SIDED|95.0|-74.1|75.3|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||75.3|-74.1|
71121336|NCT03060512|141748870|OTHER|||||||0.9239|||||||Prescott's test|||Assessment of the difference in preference for the two treatments (Prefer Movantik, No Preference, Prefer PEG 3350) in subjects who completed the entire treatment sequence.||||0.9239
71121337|NCT03060512|141748870|OTHER|||||||0.8874|||||||Prescott's test|||Assessment of the difference between preference for treatment in Period 1, preference for treatment in Period 2, no preference||||0.8874
71121338|NCT03060512|141748873|OTHER||Least Squares (LS) Means difference|0.0|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.3|0.3||||||Analysis of variance (ANOVA) model assessing treatment difference in PGIC at Visits 3 and 5 between Movantik and PEG 3350 treatment. Adjustments were performed for treatment, period and sequence.||0.3|-0.3|
71121339|NCT03060512|141748875|OTHER||LS Means difference|-0.9|STANDARD_ERROR_OF_MEAN|1.95|||TWO_SIDED|95.0|-4.7|3.0||||||Analysis of Covariance (ANCOVA) model assessing treatment difference in BFI change from baseline at Visits 3/5 between Movantik and PEG 3350. Adjustments were performed for for baseline BFI score, treatment, period and sequence.||3.0|-4.7|
71082556|NCT03272347|141672062|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|1.5|||||TWO_SIDED|95.0|-70.7|73.8|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||73.8|-70.7|
71082557|NCT03272347|141672062|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-80.8|||||TWO_SIDED|95.0|-165.6|4.0|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||4.0|-165.6|
71082558|NCT03272347|141672063|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-25.5|||||TWO_SIDED|95.0|-134.8|83.8|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||83.8|-134.8|
71082559|NCT03272347|141672063|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-107.6|||||TWO_SIDED|95.0|-212.1|-3.1|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||-3.1|-212.1|
71082560|NCT03272347|141672063|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-132.4|||||TWO_SIDED|95.0|-242.9|-21.9|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||-21.9|-242.9|
71082561|NCT03272347|141672064|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-65.6|||||TWO_SIDED|95.0|-195.3|64.0|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||64.0|-195.3|
71082562|NCT03272347|141672064|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-61.0|||||TWO_SIDED|95.0|-188.7|66.8|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||66.8|-188.7|
71082563|NCT03272347|141672064|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-107.1|||||TWO_SIDED|95.0|-231.2|16.9|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||16.9|-231.2|
71082564|NCT03272347|141672066|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|4.9|||||TWO_SIDED|95.0|-20.3|29.6|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||29.6|-20.3|
71121340|NCT02370004|141748877|OTHER|||||||0.1|||||||t-test, 2 sided|||Paired T-tests were used to evaluate changes in spirometry results||||.10
71121341|NCT02498067|141748893|OTHER|||||||0.177||||||a priori threshold for statistical significance: p\<0.05|t-test, 2 sided|||Paired samples t-test comparison of whether participants' mean reported scores for frequency of dual method use differ between baseline (pre-rPlan) and 3-month follow-up (post-rPlan)||||.177
71121342|NCT02498067|141748894|OTHER|||||||0.318||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of whether participants' mean reported scores for frequency of condom use alone (without another method) differ between baseline (pre-rPlan) and 3-month follow-up (post-rPlan)||||.318
71121343|NCT02498067|141748895|OTHER|||||||0||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of whether participants reported more consistent contraceptive use (i.e., using contraception every time they had sex) between baseline (pre-rPlan) and 3-month follow-up (post-rPlan)||||.000
71121344|NCT02498067|141748897|OTHER|||||||0.03||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported likelihood to use an IUD in the future (on a scale ranging from 1- very unlikely, to 5- very likely) before and directly after using the rPlan app||||.030
71082565|NCT03272347|141672066|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|9.5|||||TWO_SIDED|95.0|-15.4|33.5|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||33.5|-15.4|
71082566|NCT03272347|141672066|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|-5.3|||||TWO_SIDED|95.0|-30.6|20.7|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||20.7|-30.6|
71082567|NCT03272347|141672067|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|-3.6|||||TWO_SIDED|95.0|-17.9|8.5|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||8.5|-17.9|
70855651|NCT02880956|141198400|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.661||0.776|TWO_SIDED|95.0|-1.488|1.112||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.112|-1.488|0.776
70855652|NCT02880956|141198400|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|4.93|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855653|NCT02880956|141198400|SUPERIORITY||LS Mean of Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.58||0.316|TWO_SIDED|95.0|-1.723|0.558||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.558|-1.723|0.316
70855654|NCT02880956|141198400|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|4.01|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855655|NCT02880956|141198400|SUPERIORITY||LS Mean of Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.567||0.336|TWO_SIDED|95.0|-1.66|0.569||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.569|-1.660|0.336
70855656|NCT02880956|141198400|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|3.9|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855657|NCT02880956|141198400|SUPERIORITY||LS Mean of Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.587||0.403|TWO_SIDED|95.0|-1.647|0.663||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.663|-1.647|0.403
70855658|NCT02880956|141198400|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|3.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855659|NCT02880956|141198401|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.4||0.861|TWO_SIDED|95.0|-0.856|0.716||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.716|-0.856|0.861
70855660|NCT02880956|141198401|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|3.51|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855661|NCT02880956|141198401|SUPERIORITY||LS Mean of Difference|0.13|STANDARD_ERROR_OF_MEAN|0.395||0.746|TWO_SIDED|95.0|-0.648|0.905||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.905|-0.648|0.746
71082568|NCT03272347|141672067|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|-3.6|||||TWO_SIDED|95.0|-17.9|8.2|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||8.2|-17.9|
71082569|NCT03272347|141672067|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|3.8|||||TWO_SIDED|95.0|-11.5|20.6|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||20.6|-11.5|
70855662|NCT02880956|141198401|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|3.46|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855663|NCT02880956|141198401|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.405||0.859|TWO_SIDED|95.0|-0.724|0.868||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.868|-0.724|0.859
70855664|NCT02880956|141198401|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|3.64|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855665|NCT02880956|141198401|SUPERIORITY||LS Mean of Difference|0.55|STANDARD_ERROR_OF_MEAN|0.467||0.24|TWO_SIDED|95.0|-0.369|1.469||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.469|-0.369|0.240
70855666|NCT02880956|141198401|SUPERIORITY||Effect size/pooled SD|0.16|STANDARD_DEVIATION|3.41|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855667|NCT02880956|141198401|SUPERIORITY||LS Mean of Difference|0.91|STANDARD_ERROR_OF_MEAN|0.454||0.044|TWO_SIDED|95.0|0.023|1.087||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.087|0.023|0.044
70855668|NCT02880956|141198401|SUPERIORITY||Effect size/pooled SD|0.26|STANDARD_DEVIATION|3.51|||TWO_SIDED|||||||||Week 48||||
70855669|NCT02880956|141198401|SUPERIORITY||LS Mean of Difference|0.61|STANDARD_ERROR_OF_MEAN|0.467||0.195|TWO_SIDED|95.0|-0.312|1.524||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.524|-0.312|0.195
70855670|NCT02880956|141198401|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|3.53|||TWO_SIDED|||||||||Week 48||||
70855671|NCT02880956|141198401|SUPERIORITY||LS Mean of Difference|0.15|STANDARD_ERROR_OF_MEAN|0.547||0.778|TWO_SIDED|95.0|-0.921|1.229||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.229|-0.921|0.778
70855672|NCT02880956|141198401|OTHER||Effect size/pooled SD|0.04|STANDARD_DEVIATION|3.99|||TWO_SIDED|||||||||Week 72||||
70855673|NCT02880956|141198401|SUPERIORITY||LS Mean of Difference|0.32|STANDARD_ERROR_OF_MEAN|0.539||0.558|TWO_SIDED|95.0|-0.743|1.376||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.376|-0.743|0.558
70855674|NCT02880956|141198401|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|3.89|||TWO_SIDED|||||||||Week 72||||
70855675|NCT02880956|141198401|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.546||0.928|TWO_SIDED|95.0|-1.025|1.124||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.124|-1.025|0.928
70944290|NCT03226106|141388516|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.724|TWO_SIDED|95.0|-1.4|1.32||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||1.32|-1.40|0.724
71082570|NCT01677182|141672079|SUPERIORITY_OR_OTHER||Least Squares Mean Differences|0.8|STANDARD_ERROR_OF_MEAN|0.98||0.783|TWO_SIDED|97.5|-1.4|3.0||Mixed Model Repeated Measures (MMRM) model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||3.0|-1.4|0.783
70855676|NCT02880956|141198401|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|4.27|||TWO_SIDED|||||||||Week 72||||
70855677|NCT02880956|141198401|SUPERIORITY||LS Mean of Difference|0.64|STANDARD_ERROR_OF_MEAN|0.541||0.238|TWO_SIDED|95.0|-0.425|1.704||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.704|-0.425|0.238
71082571|NCT01677182|141672079|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.97||0.329|TWO_SIDED|97.5|-2.6|1.7||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||1.7|-2.6|0.329
71121345|NCT02498067|141748898|OTHER|||||||0.14||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported likelihood to use an implant in the future (on a scale ranging from 1- very unlikely, to 5- very likely) before and directly after using the rPlan app||||.140
71121346|NCT02498067|141748899|OTHER|||||||0.315||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported likelihood to use condoms in the future (on a scale ranging from 1- very unlikely, to 5- very likely) before and directly after using the rPlan app||||.315
71121347|NCT02498067|141748900|OTHER|||||||0.028||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported contraceptive self-efficacy (on a scale ranging from 1- not at all confident, to 5- extremely confident) before and 3 months after engaging in rPlan||||.028
71121348|NCT02498067|141748901|OTHER|||||||0.918||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported condom use self-efficacy (on a scale ranging from 1- not at all confident, to 5- extremely confident) before and 3 months after engaging in rPlan||||.918
71121349|NCT02498067|141748903|OTHER|||||||0.209||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' self-reported number of sexual partners in the past 3 months (for those were sexually active) between baseline and 3-month follow-up||||.209
71121350|NCT02498067|141748904|OTHER|||||||0.652||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported degree to which they endorse negative condom attitudes (on a scale ranging from 1- strongly disagree, to 5- strongly agree) before and 3 months after engaging in rPlan||||.652
71121351|NCT02498067|141748905|OTHER|||||||0.498||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported degree to which they endorse positive motivators for condom use (on a scale ranging from 1- strongly disagree, to 5- strongly agree) before and 3 months after engaging in rPlan||||.498
71121352|NCT02498067|141748906|OTHER|||||||0.977||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' rated importance of negative contraceptive attitudes on their decision to use contraception (on a scale ranging from 1- not at all important, to 5- extremely important) before and 3 months after engaging in rPlan||||.977
71121353|NCT02498067|141748907|OTHER|||||||0.673||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' rated importance of positive motivators for contraceptive use on their decision to use contraception (on a scale ranging from 1- not at all important, to 5- extremely important) before and 3 months after engaging in rPlan||||.673
71121354|NCT02498067|141748908|OTHER|||||||0.049||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of proportion of participants who provided correct answers to whether pills or condoms are more effective at preventing pregnancy, before and 3 months after engaging in rPlan||||.049
71121355|NCT02498067|141748908|OTHER|||||||0.265||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of proportion of participants who provided correct answers to whether the IUD or shot is more effective at preventing pregnancy, before and 3 months after engaging in rPlan||||.265
71121356|NCT00747344|141748909|SUPERIORITY_OR_OTHER||||||<|0.001||||||The study was designed to maintain a Type I error of 0.05 or less for the primary analysis.|Cochran-Mantel-Haenszel|Stratified by baseline weight (≤ 65 kg vs \> 65 kg).||Null Hypothesis: No difference between ustekinumab 45 mg and placebo for the primary endpoint at a significance level of 0.05. With 120 subjects (60 in each treatment group), simulation studies were conducted to calculate the power to detect a treatment difference in the primary endpoint between ustekinumab 45 mg group and placebo using a CMH test stratified by baseline weight (\<=65kg vs \> 65 kg). For all the scenarios evaluated, the power was \> 99% at a significance level of 0.05.||||<0.001
71121357|NCT00747344|141748910|SUPERIORITY_OR_OTHER||||||<|0.001||||||No multiplicity adjustment was made and nominal p-value was reported.|Cochran-Mantel-Haenszel|Stratified by baseline weight (≤ 65 kg vs \> 65 kg).||Null Hypothesis: No difference between ustekinumab 45 mg and placebo at a significance level of 0.05.||||<0.001
70855678|NCT02880956|141198401|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|3.61|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71082572|NCT01677182|141672080|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.27||0.088|TWO_SIDED|97.5|-0.1|1.1||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||1.1|-0.1|0.088
71082573|NCT01677182|141672080|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.27||0.642|TWO_SIDED|97.5|-0.7|0.5||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||0.5|-0.7|0.642
71082574|NCT01677182|141672081|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.792|TWO_SIDED|97.5|-0.2|0.3||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||0.3|-0.2|0.792
71121358|NCT00747344|141748911|SUPERIORITY_OR_OTHER||||||<|0.001||||||No multiplicity adjustment was made and nominal p-value was reported.|ANOVA|Analysis of variance on van der Waerden normal scores (Conover, 1980) with treatment and baseline weight (≤ 65kg vs \> 65 kg) as factors in the model.||Null Hypothesis: No difference between ustekinumab 45 mg and placebo at a significance level of 0.05.||||<0.001
71082575|NCT01677182|141672081|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.171|TWO_SIDED|97.5|-0.4|0.1||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||0.1|-0.4|0.171
71082576|NCT01677182|141672082|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.653|TWO_SIDED|97.5|-0.2|0.3||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||0.3|-0.2|0.653
71082577|NCT01677182|141672082|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.673|TWO_SIDED|97.5|-0.3|0.2||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||0.2|-0.3|0.673
71082578|NCT01677182|141672083|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.51||0.119|TWO_SIDED|97.5|-0.4|2.0||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||2.0|-0.4|0.119
71121359|NCT00765882|141748917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.93||||0.0012|TWO_SIDED|95.0|1.5|5.72||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null hypothesis: There is no difference in the proportion of 12-week CSBM overall responders between patients taking the 145-μg dose and those taking placebo.~The power, adjusted for multiplicity, was expected to be 90% based on study NCT00402337 (MCP-103-201) data."||5.72|1.50|0.0012
71121360|NCT00765882|141748917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.22|||<|0.0001|TWO_SIDED|95.0|2.2|8.1||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null hypothesis: There is no difference in the proportion of 12-week CSBM overall responders between patients taking the 290-μg dose and those taking placebo.~The power, adjusted for multiplicity, was expected to be 96% based on study NCT00460811 (MCP-103-202) data."||8.10|2.20|<0.0001
71121361|NCT02337530|141748925|SUPERIORITY||Odds Ratio (OR)|1.37||||0.73|TWO_SIDED|95.0|0.28|7.01|||Fisher Exact|||||7.01|0.28|0.73
71121362|NCT02337530|141748925|SUPERIORITY||Odds Ratio (OR)|6.4||||0.01|TWO_SIDED|95.0|1.65|24.8|||Fisher Exact|||||24.8|1.65|0.01
71082579|NCT01677182|141672083|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.51||0.791|TWO_SIDED|97.5|-1.3|1.0||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||1.0|-1.3|0.791
71082580|NCT01677182|141672084|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.7||0.422|TWO_SIDED|97.5|-1.0|2.1||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||2.1|-1.0|0.422
71082581|NCT01677182|141672084|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.7||0.655|TWO_SIDED|97.5|-1.3|1.9||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||1.9|-1.3|0.655
71082582|NCT01677182|141672085|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.64||0.696|TWO_SIDED|97.5|-4.5|2.8||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||2.8|-4.5|0.696
71121363|NCT02337530|141748926|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.56|TWO_SIDED|95.0|0.42|1.6|||Log Rank|||||1.60|0.42|0.56
71121364|NCT02337530|141748926|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.44|TWO_SIDED|95.0|0.4|1.49|||Log Rank|||||1.49|0.40|0.44
70855679|NCT02880956|141198401|SUPERIORITY||LS Mean of Difference|0.86|STANDARD_ERROR_OF_MEAN|0.53||0.107|TWO_SIDED|95.0|-0.186|1.898||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.898|-0.186|0.107
70855680|NCT02880956|141198401|SUPERIORITY||Effect size/pooled SD|0.25|STANDARD_DEVIATION|3.41|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855681|NCT02880956|141198401|SUPERIORITY||LS Mean of Difference|0.86|STANDARD_ERROR_OF_MEAN|0.548||0.116|TWO_SIDED|95.0|-0.214|1.942||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.942|-0.214|0.116
70855682|NCT02880956|141198401|SUPERIORITY||Effect size/pooled SD|0.23|STANDARD_DEVIATION|3.75|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855683|NCT02880956|141198402|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.186||0.683|TWO_SIDED|95.0|-0.442|0.29||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.290|-0.442|0.683
70855684|NCT02880956|141198402|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.98|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855685|NCT02880956|141198402|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.184||0.973|TWO_SIDED|95.0|-0.356|0.368||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.368|-0.356|0.973
70855686|NCT02880956|141198402|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|1.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855687|NCT02880956|141198402|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.189||0.921|TWO_SIDED|95.0|-0.389|0.352||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.352|-0.389|0.921
70855688|NCT02880956|141198402|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|1.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855689|NCT02880956|141198402|SUPERIORITY||LS Mean of Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.256||0.335|TWO_SIDED|95.0|-0.751|0.257||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.257|-0.751|0.335
70855690|NCT02880956|141198402|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|2.2|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855691|NCT02880956|141198402|SUPERIORITY||LS Mean of Difference|0.11|STANDARD_ERROR_OF_MEAN|0.249||0.67|TWO_SIDED|95.0|-0.383|0.596||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.596|-0.383|0.670
70855692|NCT02880956|141198402|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|2.01|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855693|NCT02880956|141198402|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.256||0.95|TWO_SIDED|95.0|-0.486|0.519||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.519|-0.486|0.950
71121365|NCT01945775|141748983|SUPERIORITY||Hazard Ratio, log|0.542|||<|0.0001|TWO_SIDED|95.0|0.413|0.711|||Log Rank|||Hazard ratio was based on stratified Cox regression model with treatment as the only covariate (stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system metastasis status).||0.711|0.413|<0.0001
70855694|NCT02880956|141198402|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|2.04|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70944291|NCT03226106|141388517|SUPERIORITY||Mean Difference (Final Values)|7.49||||0.547|TWO_SIDED|95.0|-18.9|33.89||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||33.89|-18.90|0.547
70944292|NCT03226106|141388518|SUPERIORITY||Mean Difference (Final Values)|4.93||||0.716|TWO_SIDED|95.0|-21.67|31.54||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||31.54|-21.67|0.716
70944293|NCT03226106|141388519|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.946|TWO_SIDED|95.0|-0.88|0.82||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||0.82|-0.88|0.946
70944294|NCT03226106|141388520|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.906|TWO_SIDED|95.0|-1.08|0.52||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||0.52|-1.08|0.906
70944295|NCT03226106|141388521|SUPERIORITY||Mean Difference (Final Values)|-1.55||||0.873|TWO_SIDED|95.0|-7.59|4.49||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||4.49|-7.59|0.873
70944296|NCT03226106|141388522|SUPERIORITY||Mean Difference (Final Values)|-6.26||||0.241|TWO_SIDED|95.0|-12.48|-0.04||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||-0.04|-12.48|0.241
70944297|NCT03226106|141388523|SUPERIORITY||Mean Difference (Final Values)|2.86||||0.223|TWO_SIDED|95.0|-0.39|6.12||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||6.12|-0.39|0.223
70944298|NCT03226106|141388524|SUPERIORITY||Mean Difference (Final Values)|1.17||||0.388|TWO_SIDED|95.0|-2.19|4.53||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||4.53|-2.19|0.388
70944299|NCT03226106|141388525|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.88|TWO_SIDED|95.0|-4.08|2.68||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||2.68|-4.08|0.88
70944300|NCT03226106|141388526|SUPERIORITY||Mean Difference (Final Values)|0.77||||0.85|TWO_SIDED|95.0|-2.63|4.17||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||4.17|-2.63|0.85
70944301|NCT03226106|141388527|SUPERIORITY||Mean Difference (Final Values)|559.81||||0.101|TWO_SIDED|95.0|-405.01|1524.62||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||1524.62|-405.01|0.101
70944302|NCT00637247|141388536|SUPERIORITY_OR_OTHER|||||||0.2|||||||Log Rank|||The hypothesis that survival curves were equal in the two treatment groups was tested with a one-sided logrank test at the alpha-0.2 level, one sided. The power of this test is 80% for detecting the hypothesized increase in median survival of 2.4 months for subjects in the experimental arm.||||0.2
70944303|NCT01772823|141388578|OTHER|||||||0.7513||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on the Size of the Pill) differ between intervention arms."|Chi-squared|||||||0.7513
70944304|NCT01772823|141388579|OTHER|||||||0.8281||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on the Taste of the Pill) differ between intervention arms."|Chi-squared|Pearson Chi-Square||||||0.8281
71121366|NCT01945775|141748984|SUPERIORITY||Odds Ratio (OR)|4.99|||<|0.0001|TWO_SIDED|95.0|2.93|8.83|||Cochran-Mantel-Haenszel|||p-value was based on stratified Cochran-Mantel-Haenszel method. Stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system metastasis status.||8.83|2.93|<0.0001
70944305|NCT01772823|141388580|OTHER|||||||0.3761||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on the Color of the Pill) differ between intervention arms."|Chi-squared|||||||0.3761
70944306|NCT01772823|141388581|OTHER|||||||0.4359||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on Taking the pill every day) differ between intervention arms."|Chi-squared|||||||0.4359
70944307|NCT01772823|141388582|OTHER|||||||0.3801||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on Taking part in the study) differ between intervention arms."|Chi-squared|||||||0.3801
70944308|NCT01772823|141388583|OTHER|||||||0.1968||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on HIV test at every visit) differ between intervention arms."|Chi-squared|||||||0.1968
70944309|NCT01772823|141388584|OTHER|||||||0.1226||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on Risk Reduction counseling at every visit) differ between intervention arms."|Chi-squared|||||||0.1226
70944310|NCT01772823|141388585|OTHER|||||||0.0994||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on Questions about sexual behavior) differ between intervention arms."|Chi-squared|||||||0.0994
70944311|NCT01772823|141388586|OTHER|||||||0.5285||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on the Physician exam) differ between intervention arms."|Chi-squared|||||||0.5285
70944312|NCT01772823|141388590|OTHER|||||||0.0001||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.0001
70944313|NCT01772823|141388591|OTHER|||||||0.0098||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.0098
70944314|NCT01772823|141388592|OTHER|||||||0.0766||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.0766
70944315|NCT01772823|141388593|OTHER|||||||0.1581||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.1581
71082583|NCT01677182|141672085|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.63||0.472|TWO_SIDED|97.5|-3.6|3.8||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||3.8|-3.6|0.472
71082584|NCT01677182|141672086|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.998||||0.994|TWO_SIDED|95.0|0.651|1.53||Odds ratio, 95% confidence intervals and p-values are analyzed from logistic regression with explanatory variables for treatment and baseline MADRS total score.|Regression, Logistic|||||1.530|0.651|0.994
71121367|NCT01945775|141748985|SUPERIORITY||Hazard Ratio (HR)|0.848||||0.1693|TWO_SIDED|95.0|0.67|1.073|||Log Rank|||Hazard ratio was based on stratified Cox regression model with treatment as the only covariate (stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system metastasis status).||1.073|0.670|0.1693
71121368|NCT01945775|141748993|SUPERIORITY||Mean Difference (Final Values)|8.4|||<|0.0001|TWO_SIDED|95.0|4.6|12.3|||Mixed Models Analysis|||Analysis was based on repeated measures mixed-effect model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate. Analysis was based on restricted maximum likelihood using unstructured covariance matrix.||12.3|4.6|<0.0001
71121369|NCT01945775|141748994|SUPERIORITY||Hazard Ratio (HR)|0.376|||<|0.0001|TWO_SIDED|95.0|0.257|0.549|||Log Rank|||Hazard ratio is based on stratified Cox regression model with treatment as the only covariate (stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system metastasis status).||0.549|0.257|<0.0001
70944316|NCT01772823|141388594|OTHER|||||||0.43||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.4300
70944317|NCT01772823|141388595|OTHER|||||||0.1201||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.1201
70944318|NCT01772823|141388596|OTHER|||||||0.1682||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.1682
70944319|NCT01772823|141388597|OTHER|||||||0.2747||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.2747
70944320|NCT01772823|141388598|OTHER|||||||0.0046||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.0046
70944321|NCT01772823|141388599|OTHER|||||||0.029||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.0290
70944322|NCT01772823|141388600|OTHER|||||||0.107|||||||Kruskal-Wallis|||||||0.1070
70944323|NCT01772823|141388602|OTHER|||||||0.2991||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant self-identified race) differ between groups (On PrEP vs. Off PrEP).|Fisher Exact|||||||0.2991
70944324|NCT01772823|141388603|OTHER|||||||0.0298||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant self-identified race) differ between groups (On PrEP vs. Off PrEP).|Fisher Exact|||||||0.0298
70944325|NCT01772823|141388604|OTHER|||||||0.8643||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant self-identified ethnicity) differ between groups (On PrEP vs. Off PrEP).|Fisher Exact|||||||0.8643
70944326|NCT01772823|141388605|OTHER|||||||0.9037||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant BMI) differ between groups (On PrEP vs. Off PrEP).|Fisher Exact|||||||0.9037
71121370|NCT01945775|141748995|SUPERIORITY||Hazard Ratio (HR)|0.392||||0.0053|TWO_SIDED|95.0|0.198|0.775|||Log Rank|||Hazard ratio is based on stratified Cox regression model with treatment as the only covariate (stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system).||0.775|0.198|0.0053
71121371|NCT02876328|141748996|SUPERIORITY||||||<|0.001||||||Each active group is compared to placebo using a 2-sided .0167 significance level.|Cochran-Mantel-Haenszel|Analyses are stratified by site.||Analysis applies to both adults and children.||||<.001
71121372|NCT03849690|141748999|OTHER|Analysis of variance (ANOVA) performed on natural log(ln)-transformed TAK-906 Cmax which exponentiated to provide estimates on original scale. ANOVA model included treatment as fixed effect and participant as random effect. Each ANOVA included calculation of least-squares means(LSM) and difference between treatment LSM. Geometric mean ratios and 90% confidence interval (CI) were determined by exponentiation of appropriate estimates for difference between treatments in log-transformed parameters.|Geometric mean ratio|0.87||||0.3011|TWO_SIDED|90.0|0.7|1.09|||ANOVA|||||1.09|0.70|0.3011
71121373|NCT03849690|141749000|OTHER|ANOVA was performed on ln-transformed TAK-906 AUClast which were exponentiated to provide estimates on original scale. ANOVA model included treatment as fixed effect and participant as a random effect. Each ANOVA included calculation of LSM and difference between treatment LSM. Geometric mean ratios and 90 percent (%) CI were determined by exponentiation of appropriate estimates for difference between treatments in log-transformed parameters.|Geometric mean ratio|0.88||||0.0865|TWO_SIDED|90.0|0.77|0.99|||ANOVA|||||0.99|0.77|0.0865
71121374|NCT03849690|141749001|OTHER|ANOVA was performed on ln-transformed TAK-906 AUC∞ which were exponentiated to provide estimates on original scale. ANOVA model included treatment as fixed effect and participant as a random effect. Each ANOVA included calculation of LSM and difference between treatment LSM. Geometric mean ratios and 90% CI were determined by exponentiation of appropriate estimates for difference between treatments in log-transformed parameters.|Geometric mean ratio|0.88||||0.3011|TWO_SIDED|90.0|0.78|1.0|||ANOVA|||||1.00|0.78|0.3011
71121375|NCT00334282|141749013|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46||||1e-07||95.0|0.34|0.62||stratified log-rank test|Log Rank||The estimated value is the hazard ratio comparing pazopanib to placebo.|||0.62|0.34|.0000001
71121376|NCT00468845|141749024|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1378||95.0||||Weighted Z-score test method of Fisher (1998) and Cui et al (1999)applied to maintain alpha level. A step down procedure for multiple comparisons to control the maximum experiment wise type I error rate at 0.05 level. 300mg tested prior to 150mg.|ANOVA|||||||0.1378
71121377|NCT00468845|141749024|SUPERIORITY_OR_OTHER_LEGACY|||||||0.471||95.0||||Weighted Z-score test method of Fisher (1998) and Cui et al (1999)applied to maintain alpha level. A step down procedure for multiple comparisons to control the maximum experiment wise type I error rate at 0.05 level. 300mg tested prior to 150mg.|ANOVA|||||||0.4710
71121378|NCT00468845|141749025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7752||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.7752
71121379|NCT00468845|141749025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3375||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.3375
71121380|NCT00468845|141749025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7029||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.7029
71121381|NCT00468845|141749025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8618||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.8618
71121382|NCT00468845|141749025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2117||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.2117
71121383|NCT00468845|141749025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6255||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.6255
70855695|NCT02880956|141198402|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.257||0.383|TWO_SIDED|95.0|-0.729|0.281||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.281|-0.729|0.383
71121384|NCT00468845|141749025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0942||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS||||0.0942
71121385|NCT00468845|141749025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9907||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS||||0.9907
71121386|NCT00468845|141749025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4678||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS||||0.4678
71121387|NCT00468845|141749025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS||||0.5500
71121388|NCT00468845|141749025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9333||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||144 hours PS||||0.9333
71121389|NCT00468845|141749025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7396||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||144 hours PS||||0.7396
71121390|NCT00468845|141749025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2932||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.2932
70944327|NCT01772823|141388606|OTHER|||||||0.5279|||||||Kruskal-Wallis|||||||0.5279
71082585|NCT01677182|141672086|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.886||||0.575|TWO_SIDED|95.0|0.58|1.352||Odds ratio, 95% confidence intervals and p-values are analyzed from logistic regression with explanatory variables for treatment and baseline MADRS total score.|Regression, Logistic|||||1.352|0.580|0.575
71082586|NCT01677182|141672087|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.978||||0.927|TWO_SIDED|95.0|0.606|1.577||Odds ratio, 95% confidence intervals and p-values are analyzed from logistic regression with explanatory variables for treatment and baseline MADRS total score.|Regression, Logistic|||||1.577|0.606|0.927
71082587|NCT01677182|141672087|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.865||||0.553|TWO_SIDED|95.0|0.536|1.397||Odds ratio, 95% confidence intervals and p-values are analyzed from logistic regression with explanatory variables for treatment and baseline MADRS total score.|Regression, Logistic|||||1.397|0.536|0.553
71082588|NCT00995722|141672089|NON_INFERIORITY_OR_EQUIVALENCE|N=80, (40 per group), 80% power to detect a group difference of 30%-35% and 5% significance level.|Mean Difference (Final Values)|-2.2||||0.37|TWO_SIDED|95.0|-7.2|2.8|||ANCOVA|ANCOVA used to compare mean values adjusting for the baseline value|QMG Score ranges from 0-15, where 0 is normal and a reduction in score represents imrovement.|Mean Ocular QMG Changes from Baseline to Week 16 . 95% CI and p-values obtained from the analysis of covariance model to adjust for the baseline value of the outcome variable.||2.8|-7.20|0.37
71082589|NCT00995722|141672090|NON_INFERIORITY_OR_EQUIVALENCE|Mean Change in quality of life as measured by the NEI-VFQ-25 at the end of Double- Blinded Treatment|Mean Difference (Net)|6.56||||0.13|TWO_SIDED|95.0|-2.59|15.71|||ANCOVA||Scores ranges fro 0-100 , where 100 is normal and an increase in score represents an improvement|Mean Change in quality of life as measured by the NEI-VFQ-25 at the end of Double- Blinded Treatment. 95% CI and p-values obtained from the analysis of covariance model to adjust for the baseline value of the outcome variable.||15.71|-2.59|0.13
71082590|NCT00995722|141672091|NON_INFERIORITY_OR_EQUIVALENCE|Mean Change in quality if life as measured by the MG-QOL-15 score at the end of Double- Blinded Treatment|Mean Difference (Final Values)|-3.81||||0.15|TWO_SIDED|95.0|-9.37|1.75|||ANCOVA||Ranges from 0-60, where 0 is Normal and a reduction in score represents improvement.|Mean Change in quality if life as measured by the MG-QOL-15 score at the end of Double- Blinded Treatment. 95% CI and p-values obtained from the analysis of covariance model to adjust for the baseline value of the outcome variable.||1.75|-9.37|0.15
71082591|NCT00995722|141672092|NON_INFERIORITY_OR_EQUIVALENCE|Mean Change NEI-VFQ-25 10 item neuro-opthtalmological supplement score baseline to week 16.|Mean Difference (Final Values)|16.98||||0.16|TWO_SIDED|95.0|-9.22|43.17|||ANCOVA||Ranges 0-100, where 100 is normal and an increase in score represents an improvement.|Mean Change NEI-VFQ-25 10 item neuro-opthtalmological supplement score baseline to week 16. 95% CI and p-values obtained from the analysis of covariance model to adjust for the baseline value of the outcome variable.||43.17|-9.22|0.16
70855696|NCT02880956|141198402|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|2.33|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855697|NCT02880956|141198402|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.254||0.985|TWO_SIDED|95.0|-0.504|0.494||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.494|-0.504|0.985
70855698|NCT02880956|141198402|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|2.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71082592|NCT00762762|141672093|OTHER|||||||0.05|TWO_SIDED|95.0|||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.05
71082593|NCT00762762|141672094|OTHER|||||||0.05|TWO_SIDED|95.0|||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.05
71082594|NCT00762762|141672095|OTHER|||||||0.05|TWO_SIDED|95.0|||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.05
71082595|NCT00762762|141672096|OTHER|||||||0.05|TWO_SIDED|95.0|||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.05
71082596|NCT00762762|141672097|OTHER|||||||0.05|TWO_SIDED|95.0|||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.05
71082597|NCT00762762|141672098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71082598|NCT00762762|141672099|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71082599|NCT00762762|141672100|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71082600|NCT00762762|141672101|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71082601|NCT00762762|141672102|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71121391|NCT00468845|141749025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0164||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.0164
71121392|NCT00468845|141749025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2468||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.2468
71121393|NCT00468845|141749025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7022||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.7022
71121394|NCT00468845|141749025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7257||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.7257
71121395|NCT00468845|141749025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3854||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.3854
71082602|NCT02861664|141672148|OTHER||Least square (LS) mean difference|-0.6|||<|0.0001||95.0|-0.8|-0.4||From ANCOVA model with change from baseline in Schiff Sensitivity Score as response and treatment and baseline Schiff sensitivity score as covariates.|ANCOVA||Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|||-0.4|-0.8|<.0001
71082603|NCT03782987|141672178|OTHER||Geometric mean (gMean) ratio (%) (T/ R)|649.48|STANDARD_ERROR_OF_MEAN|27.7|||TWO_SIDED|90.0|541.29|779.29|||||Confidence intervals were calculated based on the residual error from the ANOVA. Standard error of the mean is actually intra-individual geometric coefficient of variance (gCV).|Statistical model was an analysis of variance (ANOVA) on the logarithmic scale including 'subjects' as random effect and 'treatment' as fixed effect.||779.29|541.29|
71082604|NCT03782987|141672179|OTHER||gMean ratio (%) (T/ R)|166.88|STANDARD_ERROR_OF_MEAN|17.7|||TWO_SIDED|90.0|148.42|187.64|||||Confidence intervals were calculated based on the residual error from the ANOVA. Standard error of the mean is actually intra-individual geometric coefficient of variance (gCV).|Statistical model was an analysis of variance (ANOVA) on the logarithmic scale including 'subjects' as random effect and 'treatment' as fixed effect.||187.64|148.42|
71082605|NCT03782987|141672180|OTHER||gMean ratio (%) (T/ R)|931.41|STANDARD_ERROR_OF_MEAN|25.9|||TWO_SIDED|90.0|785.19|1104.85|||||Confidence intervals were calculated based on the residual error from the ANOVA. Standard error of the mean is actually intra-individual geometric coefficient of variance (gCV).|Statistical model was an analysis of variance (ANOVA) on the logarithmic scale including 'subjects' as random effect and 'treatment' as fixed effect.||1104.85|785.19|
71082606|NCT02781818|141672184|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||||||0.77
71082607|NCT02781818|141672184|SUPERIORITY|||||||0.46|||||||Mixed Models Analysis|||||||0.46
71082608|NCT02781818|141672185|SUPERIORITY|||||||0.65|||||||Mixed Models Analysis|||||||.65
71082609|NCT02781818|141672185|SUPERIORITY|||||||0.98|||||||Mixed Models Analysis|||||||0.98
71082610|NCT02781818|141672186|SUPERIORITY|||||||0.5|||||||Mixed Models Analysis|||||||0.50
71082611|NCT02781818|141672186|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|||||||0.70
71082612|NCT00707057|141672197|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||The null versus alternative hypothesis regarding the analgesic efficacy using the SPID 8-12 was compared between the 2 treatment groups using an analysis of covariance (ANCOVA)model with each subject's outcome being his/her SPID 8-12 as the dependent variable in the ANCOVA model with terms for gender, treatment, and baseline pain score categories (stratified as ≤7 and \>7).||||<0.0001
71082613|NCT00707057|141672198|SUPERIORITY_OR_OTHER||||||<|0.0017||95.0|||||ANCOVA|||The null versus alternative hypothesis regarding the durability of analgesic efficacy using the PID scores at 24, 36, and 48 hours.An individual subject was to achieve the 2-point reduction at all 3 terminal time points in order to be defined as responder.||||<0.0017
71082614|NCT00707057|141672199|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Time to confirmed first perceptible relief was defined as the time to first perceptible relief, provided that the subject also stopped the second stopwatch indicating meaningful relief. For those who failed to achieve confirmed first perceptible and/or meaningful relief, a censored time was assigned.||||<0.0001
71082615|NCT00707057|141672200|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Time to confirmed first perceptible relief was defined as the time to first perceptible relief, provided that the subject also stopped the second stopwatch indicating meaningful relief. For those who failed to achieve confirmed first perceptible and/or meaningful relief, a censored time was assigned.||||<0.0001
71082616|NCT00707057|141672201|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
71082617|NCT00707057|141672202|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
71082618|NCT00707057|141672202|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Estimated Confidence Interval: 95%Method: Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel|||||||<0.0001
71082619|NCT00707057|141672203|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|With terms for treatment, gender, and baseline pain score categories stratified as ≤7 and \>7.||The PID at each time point prior to dose 2 was derived by substracting the pain intensity from the base line pain intensity, so that a higher value was indicative of a greater improvement. Time weighted SPID for each specified interval was derived by first multiplying each PID score by the time from the previous time point, and adding them together for each scheduled time point within the time interval. Time weighted TOTPAR for ech specified interval was similarly derived.||||<0.0001
71082620|NCT00707057|141672204|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||||||<0.0001
71082621|NCT00707057|141672205|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||The proportions of subjects who rescued at or prior to hour 8, hour 10, and hour 12 were reported and 95% confidence intervals for the corresponding parameters were calculated.||||<0.0001
71082622|NCT00707057|141672206|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||The pain relief and PID scores at individual time points were summarized by descriptive statistics. The test and reference were compared at each individual time point at 24, 36 and 48 hours.||||<0.0001
71082623|NCT00707057|141672207|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Global evaluation for dose 1, either at the time of rescue or at dose 2 whichever came first were summarized by descriptive statistics based on non-missing data. The range went from 0 (Very poor) to 10 (Excellent) units on an 11-point Pain Intensity Numerical Rating Scale (PI-NRS).||||<0.0001
71082624|NCT00707057|141672208|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P- value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||"Global evaluation scores for dose 2 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics.~The subjects were to provide global evaluation of dose 2 study medication using a range that went from 0 (Very poor) to 10 (Excellent) units on an 11-point Pain Intensity Numerical Rating Scale (PI-NRS)in response to pain relief."||||<0.0001
71082625|NCT00707057|141672208|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain scores categories.|ANCOVA|||"Maximum relief scores for dose 2 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics.~The subjects were to provide maximum relief scores for dose 2 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief."||||<0.0001
71082626|NCT00707057|141672208|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||"Overall relief scores for dose 2 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics.~The subjects were to provide overall relief scores for dose 2 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief."||||<0.0001
71082627|NCT00707057|141672209|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Global evaluation scores for dose 3 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide global evaluation of dose 3 study medication using a range that went from 0 (Very poor) to 10 (Excellent) units on an 11-point Pain Intensity Numerical Rating Scale (PI-NRS)in response to pain relief.||||<0.0001
70855699|NCT02880956|141198402|SUPERIORITY||LS Mean of Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.256||0.064|TWO_SIDED|95.0|-0.982|0.027||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.027|-0.982|0.064
70855700|NCT02880956|141198402|SUPERIORITY||Effect size/pooled SD|-0.2|STANDARD_DEVIATION|2.4|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855701|NCT02880956|141198402|SUPERIORITY||LS Mean of Difference|0.18|STANDARD_ERROR_OF_MEAN|0.28||0.527|TWO_SIDED|95.0|-0.374|0.729||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.729|-0.374|0.527
70855702|NCT02880956|141198402|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|2.3|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855703|NCT02880956|141198402|SUPERIORITY||LS Mean of Difference|0.31|STANDARD_ERROR_OF_MEAN|0.275||0.254|TWO_SIDED|95.0|-0.226|0.854||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.854|-0.226|0.254
70855704|NCT02880956|141198402|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|2.32|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855705|NCT02880956|141198402|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.284||0.805|TWO_SIDED|95.0|-0.628|0.488||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.488|-0.628|0.805
70855706|NCT02880956|141198402|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|2.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855707|NCT02880956|141198403|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.361||0.534|TWO_SIDED|95.0|-0.935|0.485||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.485|-0.935|0.534
70855708|NCT02880956|141198403|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|2.76|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855709|NCT02880956|141198403|SUPERIORITY||LS Mean of Difference|0.12|STANDARD_ERROR_OF_MEAN|0.356||0.735|TWO_SIDED|95.0|-0.58|0.821||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.821|-0.580|0.735
70855710|NCT02880956|141198403|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|2.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855711|NCT02880956|141198403|SUPERIORITY||LS Mean of Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.365||0.009|TWO_SIDED|95.0|-1.673|-0.24||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||-0.240|-1.673|0.009
70855712|NCT02880956|141198403|SUPERIORITY||Effect size/pooled SD|-0.35|STANDARD_DEVIATION|2.75|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71082628|NCT00707057|141672209|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and basee pain score categories.|ANCOVA|||Maximum relief scores for dose 3 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide maximum relief of dose 3 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief.||||<0.0001
71082629|NCT00707057|141672209|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Overall relief scores for dose 3 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide overall relief of dose 3 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief.||||<0.0001
71082630|NCT00707057|141672210|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Global evaluation scores for dose 4 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide global evaluation of dose 4 study medication using a range that went from 0 (Very poor) to 10 (Excellent) units on an 11-point Pain Intensity Numerical Rating Scale (PI-NRS)in response to pain relief.||||<0.0001
71082631|NCT00707057|141672210|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Maximum relief scores for dose 4 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide maximum relief of dose 4 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief.||||<0.0001
71082632|NCT00707057|141672210|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Overall relief scores for dose 4 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide overall relief of dose 4 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief.||||<0.0001
71121396|NCT00468845|141749026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5997||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.5997
71121397|NCT00468845|141749026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8582||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.8582
71121398|NCT00468845|141749026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3704||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.3704
71121399|NCT00468845|141749026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9747||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.9747
71121400|NCT00468845|141749026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2033||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.2033
71121401|NCT00468845|141749026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2752||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.2752
71121402|NCT00468845|141749026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0183||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS||||0.0183
71121403|NCT00468845|141749026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6906||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS||||0.6906
71121404|NCT00468845|141749026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5446||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS||||0.5446
71121405|NCT00468845|141749026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4852||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS||||0.4852
71121406|NCT00468845|141749026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5879||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||144 hours PS||||0.5879
71121407|NCT00468845|141749026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7699||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||144 hours PS||||0.7699
71121408|NCT00468845|141749027|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9676||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||||||0.9676
71121409|NCT00468845|141749027|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4944||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||||||0.4944
71121410|NCT00468845|141749028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4801||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||||||0.4801
71121411|NCT00468845|141749028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8832||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||||||0.8832
71121412|NCT00468845|141749029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2125||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||8 Hours PS||||0.2125
71121413|NCT00468845|141749029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7602||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||8 Hour PS||||0.7602
71121414|NCT00468845|141749029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4053||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||16 Hours PS||||0.4053
71121415|NCT00468845|141749029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4147||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||16 Hours PS||||0.4147
71121416|NCT00468845|141749029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5556||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 Hours PS||||0.5556
71121417|NCT00468845|141749029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.482||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 Hours PS||||0.4820
71121418|NCT00468845|141749029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5088||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||32 Hours PS||||0.5088
71121419|NCT00468845|141749029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||32 Hours PS||||0.3900
71121420|NCT00468845|141749029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9659||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||40 Hours PS||||0.9659
71121421|NCT00468845|141749029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3968||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||40 Hours PS||||0.3968
71082633|NCT04611542|141672211|SUPERIORITY||Mean Difference (Final Values)|1.02|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71082634|NCT04611542|141672212|SUPERIORITY||Median Difference (Final Values)|1.12|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
71082635|NCT04611542|141672213|SUPERIORITY||Mean Difference (Final Values)|6.32|||<|0.001|TWO_SIDED||||||t-test, 2 sided||Investigators tested whether pretest to posttest change was significantly greater than 0 at P \< 0.05.|||||<0.001
71121422|NCT00468845|141749029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8308||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 Hours PS||||0.8308
71121423|NCT00468845|141749029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0902||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 Hours PS||||0.0902
71121424|NCT00468845|141749030|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4388||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||||||0.4388
71082636|NCT00320242|141672214|SUPERIORITY||Mean Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|0.48||0.0152|TWO_SIDED|95.0|0.26|2.23|||t-test, 2 sided|two-tailed paired t-test||||2.23|0.26|0.0152
71082637|NCT00320242|141672215|SUPERIORITY||Mean Difference (Final Values)|50.0|STANDARD_ERROR_OF_MEAN|11.7||0.005|TWO_SIDED|95.0|23.9|76.1|||t-test, 2 sided|||||76.1|23.9|0.005
71121425|NCT00468845|141749030|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3364||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||||||0.3364
71121426|NCT00468845|141749031|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2409||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.2409
71121427|NCT00468845|141749031|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1654||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.1654
71121428|NCT00468845|141749031|SUPERIORITY_OR_OTHER_LEGACY|||||||0.111||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.1110
71121429|NCT00468845|141749031|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0598||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.0598
71121430|NCT00468845|141749031|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0398||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge||||0.0398
71121431|NCT00468845|141749031|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0623||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge||||0.0623
71121432|NCT00468845|141749032|SUPERIORITY_OR_OTHER_LEGACY|||||||0.273||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||0-24 Hours PS||||0.2730
71121433|NCT00468845|141749032|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1015||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||0-24 Hours PS||||0.1015
71121434|NCT00468845|141749032|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2438||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24-48 Hours PS||||0.2438
71121435|NCT00468845|141749032|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0102||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24-48 Hours PS||||0.0102
71121436|NCT00468845|141749032|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2063||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48-72 Hours PS||||0.2063
71121437|NCT00468845|141749032|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0387||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48-72 Hours PS||||0.0387
71121438|NCT00468845|141749033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5995||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.5995
71121439|NCT00468845|141749033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9104||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 Hours PS||||0.9104
71121440|NCT00468845|141749033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2177||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 Hours PS||||0.2177
71082638|NCT00320242|141672216|SUPERIORITY||Mean Difference (Net)|1.11|STANDARD_DEVIATION|1.31||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|two-tailed Wilcoxan signed-rank sum test||two-tailed Wilcoxan signed-rank sum test||||0.02
71082639|NCT00320242|141672217|OTHER|The percentage change in falls was analyzed using a two-tailed one-sample t-test with a hypothesized mean of 0||||||0.002||||||Two-tailed one-sample t-test with a hypothesized mean of 0. This analysis was not adjusted for multiple comparisons.|t-test, 2 sided|||The percentage change in falls was analyzed using a two-tailed one-sample t-test with a hypothesized mean of 0||||0.002
71082640|NCT00472732|141672218|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||The Bonferroni-corrected a priori p-value was 0.007 (a priori alpha=0.05/number of tests=7).|t-test, 2 sided|||The null hypothesis predicted that the concentration of myoinositol in posterior cingulate gray matter will be the same in OTCD patients as in controls.||||0.003
71082641|NCT00472732|141672218|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The Bonferroni-corrected a priori p-value was 0.007 (a priori alpha=0.05/number of tests=7).|t-test, 2 sided|||The null hypothesis predicted that the concentration of myoinositol in parietal white matter will be the same in OTCD patients as in controls.||||<0.001
71082642|NCT00472732|141672218|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||The Bonferroni-corrected a priori p-value was 0.007 (a priori alpha=0.05/number of tests=7).|t-test, 2 sided|||The null hypothesis predicted that the concentration of glutamine in posterior cingulate gray matter would be the same for OTCD patients as for controls.||||0.001
71082643|NCT00472732|141672218|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The Bonferroni-corrected a priori p-value was 0.007 (a priori alpha=0.05/number of tests=7).|t-test, 2 sided|||The null hypothesis predicted that the concentration of glutamine in parietal white matter would be the same for OTCD patients as for controls.||||<0.001
71082644|NCT00472732|141672219|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||This p-value is adjusted for family wise error rate correction.|t-test, 2 sided|||Two-way between-group t-tests restricted to the prefrontal cortex were performed to compare activation during for the 2-Back\> 1-Back contrast between OTCD patients and controls.||||<0.05
70944328|NCT01772823|141388607|OTHER|||||||0.5369||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participation in high-risk sex acts) differ between groups (On PrEP vs. Off PrEP).|Fisher Exact|||||||0.5369
70944329|NCT01772823|141388610|OTHER|||||||0.2193||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.2193
70944330|NCT01772823|141388611|OTHER|||||||0.1255||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.1255
70944331|NCT01772823|141388612|OTHER|||||||0.0706||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.0706
70944332|NCT01772823|141388613|OTHER|||||||0.0088||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.0088
70944333|NCT01772823|141388614|OTHER|||||||0.2482||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.2482
70944334|NCT01772823|141388615|OTHER|||||||0.1647||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.1647
70944335|NCT01772823|141388616|OTHER|||||||0.688||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.6880
70944336|NCT01772823|141388617|OTHER|||||||0.2881||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.2881
71082645|NCT00472732|141672220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis predicted that fractional anisotropy, a marker of white matter integrity, would be the same for OTCD patients as for controls.||||<0.001
70944337|NCT01772823|141388618|OTHER|||||||0.2223||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.2223
70944338|NCT01772823|141388619|OTHER|||||||0.0617||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.0617
70944339|NCT01772823|141388620|OTHER|||||||0.0868||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.0868
71121441|NCT00468845|141749033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.177||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.1770
71121442|NCT00468845|141749033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1229||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.1229
71121443|NCT00468845|141749033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1274||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.1274
70944340|NCT01772823|141388621|OTHER|||||||0.1847||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.1847
70944341|NCT01772823|141388622|OTHER|||||||0.0226||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.0226
70944342|NCT01049984|141388644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.012|TWO_SIDED|95.0|-4.3|-0.5||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted.|ANCOVA|Repeated measures model with baseline score as a covariate and factors Treatment, Week in Study, Pooled Center and Week by Treatment interaction.||||-0.5|-4.3|0.012
70944343|NCT01049984|141388645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.301|TWO_SIDED|95.0|-1.1|0.3||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted.|ANCOVA|Repeated measures model with baseline score as a covariate and factors Treatment, Week in Study, Pooled Center and Week by Treatment interaction.||||0.3|-1.1|0.301
70944344|NCT01049984|141388646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.007|TWO_SIDED|95.0|-3.1|-0.5||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted.|ANCOVA|Repeated measures model with baseline score as a covariate and factors Treatment, Week in Study, Pooled Center and Week by Treatment interaction.||||-0.5|-3.1|0.007
70944345|NCT01049984|141388647|SUPERIORITY_OR_OTHER|||||||0.255||||||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted. Only participants with assessment (\>0) are included in the CMH test.|Cochran-Mantel-Haenszel|CMH used the proportion of participants in each category between the two treatment arms, with treatment and pooled center as strata.||||||0.255
71082646|NCT02915159|141672221|SUPERIORITY|||||||0.4421|||||||longitudinal repeated measures analysis|||||||0.4421
71082647|NCT02915159|141672222|SUPERIORITY|||||||0.3367|||||||longitudinal repeated measures analysis|||||||0.3367
71082648|NCT02915159|141672223|SUPERIORITY|||||||0.5841|||||||longitudinal repeated measures analysis|||||||.5841
71082649|NCT02821416|141672265|SUPERIORITY||Median Difference (Final Values)|-5.81||||0.0208|TWO_SIDED|95.0|-10.69|-0.94|||Mixed Models Analysis|Model includes covariates of treatment, time post-allergen challenge , treatment\*time post-allergen challenge, allergen induced at screening||||-0.94|-10.69|0.0208
71121444|NCT00468845|141749033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0568||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||1st Week PS||||0.0568
71121445|NCT00468845|141749033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0354||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||1st Week PS||||0.0354
71121446|NCT00468845|141749033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4269||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS||||0.4269
71121447|NCT00468845|141749033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2058||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS||||0.2058
71121448|NCT00468845|141749033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8215||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS||||0.8215
71121449|NCT00468845|141749033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5331||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS||||0.5331
71121450|NCT00468845|141749033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7365||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS||||0.7365
71121451|NCT00468845|141749033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9989||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS||||0.9989
71121452|NCT00468845|141749033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2501||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge||||0.2501
71121453|NCT00468845|141749033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6021||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge||||0.6021
71121454|NCT00468845|141749034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6613||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day (prior to first dose)||||0.6613
71121455|NCT00468845|141749034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1311||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day (prior to first dose)||||0.1311
71121456|NCT00468845|141749034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6574||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day (1 hour after dosing)||||0.6574
71121457|NCT00468845|141749034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6949||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day (1 hour after dosing)||||0.6949
71121458|NCT00468845|141749034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2008||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS||||0.2008
71121459|NCT00468845|141749034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3022||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS||||0.3022
71121460|NCT00468845|141749034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6382||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.6382
71121461|NCT00468845|141749034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8624||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.8624
71121462|NCT00468845|141749034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3858||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.3858
71121463|NCT00468845|141749034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4814||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.4814
71121464|NCT00468845|141749034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.952||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.9520
71121465|NCT00468845|141749034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2315||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.2315
71121466|NCT00468845|141749034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7061||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.7061
71121467|NCT00468845|141749034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2908||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.2908
71121468|NCT00468845|141749034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4782||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.4782
71121469|NCT00468845|141749034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.813||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.8130
71121470|NCT00468845|141749035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.894||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.8940
71121471|NCT00468845|141749035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5938||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.5938
71121472|NCT00468845|141749035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4306||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.4306
71121473|NCT00468845|141749035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5899||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.5899
71121474|NCT00468845|141749035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2209||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.2209
71121475|NCT00468845|141749035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7145||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.7145
71121476|NCT00468845|141749035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1022||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||1st Week PS||||0.1022
71121477|NCT00468845|141749035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7243||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||1st Week PS||||0.7243
71121478|NCT00468845|141749035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.231||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS||||0.2310
71121479|NCT00468845|141749035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9192||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS||||0.9192
71121480|NCT00468845|141749035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3214||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS||||0.3214
70855713|NCT02880956|141198403|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.422||0.954|TWO_SIDED|95.0|-0.854|0.806||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.806|-0.854|0.954
70855714|NCT02880956|141198403|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|2.97|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855715|NCT02880956|141198403|SUPERIORITY||LS Mean of Difference|0.19|STANDARD_ERROR_OF_MEAN|0.412||0.649|TWO_SIDED|95.0|-0.622|0.997||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.997|-0.622|0.649
70855716|NCT02880956|141198403|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|2.95|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855717|NCT02880956|141198403|SUPERIORITY||LS Mean of Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.423||0.358|TWO_SIDED|95.0|-1.22|0.443||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.443|-1.220|0.358
71082650|NCT02821416|141672266|SUPERIORITY||Median Difference (Final Values)|2.535||||0.363|TWO_SIDED|95.0|-3.045|8.116|||Mixed Models Analysis|Model includes covariates of treatment, maximum percent decrease in FEV1 late asthma response||||8.116|-3.045|0.3630
71082651|NCT01065571|141672267|EQUIVALENCE|Non-parametric analysis of interval to relapse||||||0.046||||||result from log rank test|Log Rank|||Kaplan-Meier life table analysis was performed to compare the two groups. The null hypothesis was that there would be no difference in relapses between the two groups during the study.||||0.046
71082652|NCT01065571|141672268|SUPERIORITY|fecal calprotectin (micrograms/gm stool)||||||0.06|||||||t-test, 2 sided|||||||0.06
71082653|NCT01065571|141672269|SUPERIORITY|||||||0.02||||||not adjusted for muliple comparisons, a priori threshold of 0.05|t-test, 2 sided|||paired t-test comparing baseline and value at end of participation||||0.02
71082654|NCT01001520|141672271|SUPERIORITY_OR_OTHER|||||||0.88||||||"Because the five a priori brain regions of interest (ROIs) are highly correlated, the significance threshold was adjusted to p=0.014."|Regression, Linear|BOLD signal change was examined using random effects maximum likelihood regression.||"We hypothesized that tolcapone would increase BOLD signal, meaning there would be an increase in brain activity, in the right dorsolateral prefrontal cortex, a part of the brain known to be involved in working memory.~We analyzed for main effects of treatment (tolcapone vs. placebo), back level (0, 1, 2, and 3), treatment order, and relevant covariates (genotype, race, age, sex, FTND score, Shipley IQ score)."||||0.88
71082655|NCT01001520|141672272|SUPERIORITY_OR_OTHER|||||||0.017||||||The threshold for statistical significance was not adjusted. Significance remained at p=0.05.|Regression, Linear|Accuracy was examined using random effects maximum likelihood regression.||We hypothesized that tolcapone (vs. placebo) would increase subject's accuracy during the N-back working memory task.||||0.017
71082656|NCT01001520|141672273|SUPERIORITY_OR_OTHER|||||||0.88||||||The threshold for statistical significance was not adjusted. Significance remained at p=0.05.|Regression, Linear|Examined using random effects maximum likelihood regression.||We hypothesized that tolcapone (vs. placebo) would reduce subject's reaction time during the N-back working memory task.||||0.88
70855718|NCT02880956|141198403|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|2.99|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855719|NCT02880956|141198403|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.539||0.859|TWO_SIDED|95.0|-1.155|0.963||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.963|-1.155|0.859
70855720|NCT02880956|141198403|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|3.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71082657|NCT01001520|141672274|SUPERIORITY_OR_OTHER|||||||0.85||||||The threshold for statistical significance was not adjusted. Significance remained at p=0.05.|Regression, Linear|Examined using random effects maximum likelihood regression.||We hypothesized that smokers would smoke fewer cigarettes while taking tolcapone (vs. placebo).||||0.85
71082658|NCT01001520|141672275|SUPERIORITY_OR_OTHER|||||||0.4||||||The threshold for statistical significance was not adjusted. Significance remained at p=0.05.|Regression, Linear|Examined using random effects maximum likelihood regression.||We hypothesized that smokers, while taking tolcapone (vs. placebo), would experience less cigarette craving during their 24-hour abstinence period.||||0.40
71082659|NCT01001520|141672276|SUPERIORITY_OR_OTHER|||||||0.43||||||The threshold for statistical significance was not adjusted. Significance remained at p=0.05.|Regression, Linear|Examined using random effects maximum likelihood regression.||We hypothesized that smokers, while taking tolcapone (vs. placebo), would experience fewer withdrawal symptoms during their 24-hour abstinence period.||||0.43
71082660|NCT01001520|141672277|SUPERIORITY_OR_OTHER|||||||0.18||||||"Because the five a priori brain regions of interest (ROIs) are highly correlated, the significance threshold was adjusted to p=0.014."|Regression, Linear|BOLD signal change was examined using random effects maximum likelihood regression.||"We hypothesized that tolcapone would increase BOLD signal, meaning there would be an increase in brain activity, in the left dorsolateral prefrontal cortex, a part of the brain known to be involved in working memory.~We analyzed for main effects of treatment (tolcapone vs. placebo), back level (0, 1, 2, and 3), treatment order, and relevant covariates (genotype, race, age, sex, FTND score, Shipley IQ score)."||||0.18
71121481|NCT00468845|141749035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8641||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS||||0.8641
71121482|NCT00468845|141749035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3024||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS||||0.3024
70855721|NCT02880956|141198403|SUPERIORITY||LS Mean of Difference|0.4|STANDARD_ERROR_OF_MEAN|0.529||0.455|TWO_SIDED|95.0|-0.644|1.437||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.437|-0.644|0.455
70855722|NCT02880956|141198403|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|3.6|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855723|NCT02880956|141198403|SUPERIORITY||LS Mean of Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.538||0.335|TWO_SIDED|95.0|-1.578|0.539||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.539|-1.578|0.335
70855724|NCT02880956|141198403|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|3.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855725|NCT02880956|141198403|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.681||0.875|TWO_SIDED|95.0|-1.447|1.233||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.233|-1.447|0.875
70855726|NCT02880956|141198403|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|4.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855727|NCT02880956|141198403|SUPERIORITY||LS Mean of Difference|0.25|STANDARD_ERROR_OF_MEAN|0.668||0.712|TWO_SIDED|95.0|-1.068|1.561||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.561|-1.068|0.712
71121483|NCT00468845|141749035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7359||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS||||0.7359
71121484|NCT00468845|141749035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4303||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge||||0.4303
71121485|NCT00468845|141749035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2133||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge||||0.2133
71121486|NCT00468845|141749036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5682||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||8 hours PS||||0.5682
71121487|NCT00468845|141749036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1005||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||8 hours PS||||0.1005
71121488|NCT00468845|141749036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8261||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||16 hours PS||||0.8261
71121489|NCT00468845|141749036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9981||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||16 hours PS||||0.9981
71121490|NCT00468845|141749036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8884||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.8884
71121491|NCT00468845|141749036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4507||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.4507
71121492|NCT00468845|141749036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2994||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||32 hours PS||||0.2994
71121493|NCT00468845|141749036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4371||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||32 hours PS||||0.4371
71121494|NCT00468845|141749036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8295||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||40 hours PS||||0.8295
71121495|NCT00468845|141749036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8783||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||40 hours PS||||0.8783
71121496|NCT00468845|141749036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2161||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.2161
71121497|NCT00468845|141749036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.0440
71121498|NCT00468845|141749036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3855||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||56 hours PS||||0.3855
71121499|NCT00468845|141749036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.201||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||56 hours PS||||0.2010
71121500|NCT00468845|141749036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7104||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||64 hours PS||||0.7104
71121501|NCT00468845|141749036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6107||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||64 hours PS||||0.6107
71121502|NCT00468845|141749036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6705||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.6705
71121503|NCT00468845|141749036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2083||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.2083
71121504|NCT00468845|141749036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3234||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||80 hours PS||||0.3234
71121505|NCT00468845|141749036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5938||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||80 hours PS||||0.5938
70944346|NCT01049984|141388648|SUPERIORITY_OR_OTHER|||||||0.996||||||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted. Only participants with assessment (\>0) are included in the CMH test.|Cochran-Mantel-Haenszel|CMH used the proportion of participants in each category between the two treatment arms, with treatment and pooled center as strata.||||||0.996
71082661|NCT01001520|141672278|SUPERIORITY_OR_OTHER|||||||0.67||||||"Because the five a priori brain regions of interest (ROIs) are highly correlated, the significance threshold was adjusted to p=0.014."|Regression, Linear|BOLD signal change was examined using random effects maximum likelihood regression.||"We hypothesized that tolcapone would increase BOLD signal, meaning there would be an increase in brain activity, in the dorsal cingulate/medial prefrontal cortex, a part of the brain known to be involved in working memory.~We analyzed for main effects of treatment (tolcapone vs. placebo), back level (0, 1, 2, and 3), treatment order, and relevant covariates (genotype, race, age, sex, FTND score, Shipley IQ score)."||||0.67
71082662|NCT01001520|141672279|SUPERIORITY_OR_OTHER|||||||0.98||||||"Because the five a priori brain regions of interest (ROIs) are highly correlated, the significance threshold was adjusted to p=0.014."|Regression, Linear|BOLD signal change was examined using random effects maximum likelihood regression.||"We hypothesized that tolcapone would increase suppression of BOLD signal, meaning an increase in suppression of brain activity, in the posterior cingulate cortex, a part of the brain known to be involved in working memory.~We analyzed for main effects of treatment (tolcapone vs. placebo), back level (0, 1, 2, and 3), treatment order, and relevant covariates (genotype, race, age, sex, FTND score, Shipley IQ score)."||||0.98
70944347|NCT01049984|141388649|SUPERIORITY_OR_OTHER|||||||0.967||||||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted. Only participants with assessment (\>0) are included in the CMH test.|Cochran-Mantel-Haenszel|CMH used the proportion of participants in each category between the two treatment arms, with treatment, pooled center, and baseline value as strata.||||||0.967
71082663|NCT01001520|141672280|SUPERIORITY_OR_OTHER|||||||0.002||||||"Because the five a priori brain regions of interest (ROIs) are highly correlated, the significance threshold was adjusted to p=0.014."|Regression, Linear|BOLD signal change was examined using random effects maximum likelihood regression.||"We hypothesized that tolcapone would increase suppression of BOLD signal, meaning an increase in suppression of brain activity, in the ventromedial prefrontal cortex, a part of the brain known to be involved in working memory.~We analyzed for main effects of treatment (tolcapone vs. placebo), back level (0, 1, 2, and 3), treatment order, and relevant covariates (genotype, race, age, sex, FTND score, Shipley IQ score)."||||0.002
71082664|NCT02541422|141672281|SUPERIORITY|||||||0.45||||||p-value calculated for the total hangover scale|Wilcoxon (Mann-Whitney)|||||||0.45
71082665|NCT02541422|141672281|SUPERIORITY|||||||0.93||||||p value calculated for symptom of headache|Wilcoxon (Mann-Whitney)|||||||0.93
71082666|NCT02541422|141672281|SUPERIORITY|||||||0.11||||||p value calculated for symptom of nausea|Wilcoxon (Mann-Whitney)|||||||0.11
71082667|NCT02541422|141672281|SUPERIORITY|||||||0.72||||||p value calculated for symptom of weakness|Wilcoxon (Mann-Whitney)|||||||0.72
71082668|NCT00411450|141672309|SUPERIORITY_OR_OTHER||Difference|6.0|||||TWO_SIDED|95.0|-11.0|21.0|||||Difference = Wild type - Mutant|Difference at Week 17||21|-11|
71121506|NCT00468845|141749036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9711||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||88 hours PS||||0.9711
70944348|NCT01182103|141388692|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
70944349|NCT01182103|141388693|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
70944350|NCT01182103|141388694|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
71082669|NCT00411450|141672309|SUPERIORITY_OR_OTHER||Difference|8.0|||||TWO_SIDED|95.0|-9.0|23.0||||||Difference at Week 25||23|-9|
71082670|NCT00411450|141672311|SUPERIORITY_OR_OTHER||Difference|7.0|||||TWO_SIDED|95.0|-11.0|23.0|||||Difference = Wild type - Mutant|||23|-11|
71082671|NCT00411450|141672312|SUPERIORITY_OR_OTHER||Difference|12.5|||||TWO_SIDED|95.0|-6.3|31.4|||||Difference = Wild type - Mutant|Difference at Week 17||31.4|-6.3|
71082672|NCT00411450|141672312|SUPERIORITY_OR_OTHER||Difference|10.9|||||TWO_SIDED|95.0|-8.4|30.2||||||Difference at Week 25||30.2|-8.4|
71082673|NCT00411450|141672313|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.5|1.1|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with only KRAS effect (Wild type vs. Mutant).|||1.1|0.5|
71082674|NCT00411450|141672314|SUPERIORITY_OR_OTHER||Difference|6.0|||||TWO_SIDED|95.0|-14.0|25.0|||||Difference = Wild type - Mutant|Difference at Week 17||25|-14|
71082675|NCT00411450|141672314|SUPERIORITY_OR_OTHER||Difference|6.0|||||TWO_SIDED|95.0|-14.0|25.0||||||Difference at Week 25||25|-14|
71082676|NCT00411450|141672315|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.2|2.0|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with only KRAS effect (Wild type vs. Mutant).|||2.0|0.2|
71082677|NCT00411450|141672316|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.4|0.9|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with only KRAS effect (Wild type vs. Mutant).|||0.9|0.4|
71082678|NCT00411450|141672317|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.5|1.1|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with only KRAS effect (Wild type vs. Mutant).|||1.1|0.5|
71082679|NCT00411450|141672318|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.5|1.2|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with only KRAS effect (Wild type vs. Mutant).|||1.2|0.5|
71082680|NCT00872521|141672322|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Chi-squared|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified||||0.09
71082681|NCT00872521|141672323|SUPERIORITY_OR_OTHER|||||||0.23|||||||Chi-squared|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified||||0.23
71082682|NCT00872521|141672324|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Chi-squared|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified||||0.23
71082683|NCT00872521|141672325|SUPERIORITY_OR_OTHER|||||||0.56|||||||Chi-squared|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified||||0.56
71121507|NCT00468845|141749036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4869||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||88 hours PS||||0.4869
71082684|NCT00872521|141672326|SUPERIORITY_OR_OTHER|||||||0.01|||||||Log Rank|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified||||0.01
71082685|NCT00872521|141672327|SUPERIORITY_OR_OTHER|||||||0.28|||||||Log Rank|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified||||0.28
71082686|NCT00614874|141672337|SUPERIORITY_OR_OTHER|||||||0.048||95.0||||Comparison is between baseline and week 12|ANOVA|||||||0.048
70855728|NCT02880956|141198403|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|4.62|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855729|NCT02880956|141198403|SUPERIORITY||LS Mean of Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.687||0.269|TWO_SIDED|95.0|-2.112|0.59||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.590|-2.112|0.269
70855730|NCT02880956|141198403|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|4.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855731|NCT02880956|141198404|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.785||0.966|TWO_SIDED|95.0|-1.509|1.577||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||1.577|-1.509|0.966
70855732|NCT02880956|141198404|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|6.32|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855733|NCT02880956|141198404|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.775||0.874|TWO_SIDED|95.0|-1.646|1.4||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||1.400|-1.646|0.874
70855734|NCT02880956|141198404|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|5.89|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855735|NCT02880956|141198404|SUPERIORITY||LS Mean of Difference|0.99|STANDARD_ERROR_OF_MEAN|0.794||0.213|TWO_SIDED|95.0|-0.572|2.551||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||2.551|-0.572|0.213
70855736|NCT02880956|141198404|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|6.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855737|NCT02880956|141198404|SUPERIORITY||LS Mean of Difference|0.88|STANDARD_ERROR_OF_MEAN|0.695||0.208|TWO_SIDED|95.0|-0.49|2.242||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.242|-0.490|0.208
70855738|NCT02880956|141198404|SUPERIORITY||Effect size/pooled SD|-0.17|STANDARD_DEVIATION|5.26|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855739|NCT02880956|141198404|SUPERIORITY||LS Mean of Difference|1.03|STANDARD_ERROR_OF_MEAN|0.68||0.131|TWO_SIDED|95.0|-0.307|2.365||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.365|-0.307|0.131
70855740|NCT02880956|141198404|SUPERIORITY||Effect size/pooled SD|-0.18|STANDARD_DEVIATION|5.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855741|NCT02880956|141198404|SUPERIORITY||LS Mean of Difference|1.35|STANDARD_ERROR_OF_MEAN|0.695||0.052|TWO_SIDED|95.0|-0.014|2.719||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.719|-0.014|0.052
70855742|NCT02880956|141198404|SUPERIORITY||Effect size/pooled SD|-0.24|STANDARD_DEVIATION|5.55|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71082687|NCT00614874|141672338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|STANDARD_DEVIATION|35.0||0.183||95.0||||comparison was at baseline and week 12|Friedman|||||||0.183
71082688|NCT00614874|141672339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_DEVIATION|0.95||0.398||95.0||||Comparison was at baseline and week 12|Friedman|||||||0.398
71082689|NCT01468454|141672341|OTHER||Specificity|89.5|||||TWO_SIDED|95.0|75.2|97.1||||||||97.1|75.2|
71082690|NCT01468454|141672341|OTHER||Sensitivity|83.9|||||TWO_SIDED|95.0|72.3|92.0||||||||92|72.3|
71082691|NCT01808261|141672352|OTHER||Mean Difference (Net)|0.0443|STANDARD_ERROR_OF_MEAN|0.0809||0.713||95.0|-0.119|0.2||P-value presented is the posterior probability that the treatment difference (GSK249320 15mg/kg - placebo) is greater than 0 m/s at Month 3/Day 90.|Bayesian method|||Credible intervals are displayed as confidence intervals. Posterior means, standard deviations, and credible intervals are provided in the table.||0.2|-0.119|0.713
71082692|NCT01808261|141672353|OTHER||Mean Difference (Net)|0.0794|STANDARD_ERROR_OF_MEAN|0.0857||0.828|TWO_SIDED|95.0|-0.093|0.247||P-value presented is the posterior probability that the treatment difference (GSK249320 15mg/kg - placebo) is greater than 0 m/s at Month 6/Day 180.|Bayesian method|||Credible intervals are displayed as confidence intervals. Posterior means, standard deviations, and credible intervals are provided in the table.||0.247|-0.093|0.828
71082693|NCT01808261|141672355|OTHER||Mean Difference (Net)|2.408|STANDARD_ERROR_OF_MEAN|2.7495|||TWO_SIDED|95.0|-3.067|7.883||||||Statistical data for Day 30. The point estimate and confidence interval are for the adjusted mean difference based on least square estimates.||7.883|-3.067|
71121508|NCT00468845|141749036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7439||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS||||0.7439
71121509|NCT00468845|141749036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8045||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS||||0.8045
71121510|NCT00468845|141749036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5925||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||104 hours PS||||0.5925
71121511|NCT00468845|141749036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.683||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||104 hours PS||||0.6830
71121512|NCT00468845|141749036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8266||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||112 hours PS||||0.8266
71121513|NCT00468845|141749036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1929||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||112 hours PS||||0.1929
71121514|NCT00468845|141749036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7071||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS||||0.7071
71121515|NCT00468845|141749036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9367||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS||||0.9367
70855743|NCT02880956|141198404|SUPERIORITY||LS Mean of Difference|0.18|STANDARD_ERROR_OF_MEAN|1.062||0.866|TWO_SIDED|95.0|-1.908|2.268||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||2.268|-1.908|0.866
70855744|NCT02880956|141198404|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|6.15|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855745|NCT02880956|141198404|SUPERIORITY||LS Mean of Difference|0.46|STANDARD_ERROR_OF_MEAN|1.048||0.66|TWO_SIDED|95.0|-1.599|2.523||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||2.523|-1.599|0.660
70855746|NCT02880956|141198404|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|6.94|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71121516|NCT00468845|141749036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6046||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||128 hours PS||||0.6046
71121517|NCT00468845|141749036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5119||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||128 hours PS||||0.5119
71121518|NCT00468845|141749037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6966||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS||||0.6966
71121519|NCT00468845|141749037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1808||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS||||0.1808
71121520|NCT00468845|141749037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2616||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.2616
71121521|NCT00468845|141749037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1014||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.1014
71121522|NCT00468845|141749037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4401||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.4401
71121523|NCT00468845|141749037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5615||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.5615
71121524|NCT00468845|141749037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7615||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.7615
71121525|NCT00468845|141749037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6204||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.6204
71121526|NCT00468845|141749037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8766||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.8766
71121527|NCT00468845|141749037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1717||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.1717
70855747|NCT02880956|141198404|SUPERIORITY||LS Mean of Difference|1.91|STANDARD_ERROR_OF_MEAN|1.062||0.074|TWO_SIDED|95.0|-0.184|3.995||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||3.995|-0.184|0.074
71082694|NCT01808261|141672355|OTHER||Mean Difference (Net)|3.015|STANDARD_ERROR_OF_MEAN|2.8732|||TWO_SIDED|95.0|-2.704|8.735||||||Statistical data for Day 60. The point estimate and confidence interval are for the adjusted mean difference based on least square estimates.||8.735|-2.704|
71082695|NCT01808261|141672355|OTHER||Mean Difference (Net)|2.435|STANDARD_ERROR_OF_MEAN|3.5633|||TWO_SIDED|95.0|-4.668|9.538||||||Statistical data for Day 90. The point estimate and confidence interval are for the adjusted mean difference based on least square estimates.||9.538|-4.668|
71082696|NCT01808261|141672355|OTHER||Mean Difference (Net)|3.944|STANDARD_ERROR_OF_MEAN|3.5635|||TWO_SIDED|95.0|-3.15|11.037||||||Statistical data for Day 180. The point estimate and confidence interval are for the adjusted mean difference based on least square estimates.||11.037|-3.15|
71121528|NCT00468845|141749037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4065||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.4065
71121529|NCT00468845|141749037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0746||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.0746
71082697|NCT00941304|141672380|SUPERIORITY_OR_OTHER||LS Mean Difference|3.34||||0.4739|TWO_SIDED|95.0|-5.94|12.62|||ANCOVA|||||12.62|-5.94|.4739
71082698|NCT00941304|141672380|SUPERIORITY_OR_OTHER||LS Mean Difference|6.26||||0.2183|TWO_SIDED|95.0|-3.81|16.34|||ANCOVA|||||16.34|-3.81|.2183
71082699|NCT00941304|141672380|SUPERIORITY_OR_OTHER||LS Mean Difference|8.74||||0.0809|TWO_SIDED|95.0|-1.11|18.56|||ANCOVA|||||18.56|-1.11|.0809
71082700|NCT03293394|141672391|SUPERIORITY||||||=|0.001|||||||ANCOVA|||||||=0.001
71082701|NCT03293394|141672392|SUPERIORITY|||||||0.011|||||||ANOVA|||||||0.011
71082702|NCT03293394|141672393|SUPERIORITY|||||||0.19|||||||ANCOVA|||||||0.190
71082703|NCT03293394|141672394|SUPERIORITY|||||||0.652|||||||ANCOVA|||||||0.652
71082704|NCT03293394|141672395|SUPERIORITY|||||||0.19|||||||ANCOVA|||||||0.190
71082705|NCT03293394|141672396|SUPERIORITY|||||||0.011|||||||ANCOVA|||||||0.011
71121530|NCT00468845|141749038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2201||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.2201
70855748|NCT02880956|141198404|SUPERIORITY||Effect size/pooled SD|-0.22|STANDARD_DEVIATION|8.65|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71082706|NCT03293394|141672397|SUPERIORITY|||||||0.003|||||||ANCOVA|||||||0.003
71082707|NCT03293394|141672398|SUPERIORITY|||||||0.001|||||||ANOVA|||||||0.001
71082708|NCT01765569|141672410|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.82|||||TWO_SIDED|90.0|1.63|2.02||||||||2.02|1.63|
71121531|NCT00468845|141749038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0606||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.0606
71121532|NCT00468845|141749038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5303||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.5303
71121533|NCT00468845|141749038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2227||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.2227
71121534|NCT00468845|141749038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8237||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.8237
71121535|NCT00468845|141749038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7476||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.7476
71121536|NCT00468845|141749038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6882||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.6882
71121537|NCT00468845|141749038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9689||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.9689
71121538|NCT00468845|141749038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.501||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 6 PS||||0.5010
71121539|NCT00468845|141749038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9143||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 6 PS||||0.9143
71121540|NCT00468845|141749038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7381||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7 PS||||0.7381
71121541|NCT00468845|141749038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5336||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7 PS||||0.5336
71121542|NCT00468845|141749038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6479||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS (Average)||||0.6479
70855749|NCT02880956|141198404|SUPERIORITY||LS Mean of Difference|-0.36|STANDARD_ERROR_OF_MEAN|1.111||0.747|TWO_SIDED|95.0|-2.545|1.828||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.828|-2.545|0.747
71082709|NCT01765569|141672414|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.47|||||TWO_SIDED|90.0|1.3|1.65||||||||1.65|1.3|
71082710|NCT05568797|141672428|NON_INFERIORITY|The non-inferiority is demonstrated if the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is less than or equal (\<=) 1.5.|GMT Ratio|1.32|||||TWO_SIDED|0.95|1.13|1.53|||||The comparison was done using adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group and the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu A/Darwin/6/2021 H3N2 strain, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.53|1.13|
71082711|NCT05568797|141672428|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|1.04|||||TWO_SIDED|0.95|0.91|1.18|||||The comparison was done using adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group and the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu A/Victoria/2570/2019 H1N1 influenza strain included in the FLU vaccine, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.18|0.91|
71121543|NCT00468845|141749038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1133||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS (Average)||||0.1133
71121544|NCT00468845|141749038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7637||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS (Average)||||0.7637
71121545|NCT00468845|141749038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1056||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS (Average)||||0.1056
71121546|NCT00468845|141749038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8079||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS (Average)||||0.8079
71121547|NCT00468845|141749038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0917||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS (Average)||||0.0917
71121548|NCT00468845|141749039|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7511||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.7511
71121549|NCT00468845|141749039|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6742||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.6742
71121550|NCT00468845|141749039|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3808||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.3808
71121551|NCT00468845|141749039|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7021||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.7021
71121552|NCT00468845|141749039|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0045||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.0045
71082712|NCT05568797|141672428|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|0.97|||||TWO_SIDED|0.95|0.9|1.06|||||The comparison was done using adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group and the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu B/Austria/1359417/2021 influenza strain included in the FLU vaccine, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.06|0.90|
71082713|NCT05568797|141672428|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|1.04|||||TWO_SIDED|0.95|0.95|1.13|||||The comparison was done using adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group and the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the Flu vaccine administered alone, in terms of HI GMTs against the Flu B/Phuket/3073/2013 Yamagata influenza strain included in the FLU vaccine, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.13|0.95|
71082714|NCT05568797|141672429|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the GMT ratio (Control group divided by Co-Ad group) for RSV-A neutralizing antibody vaccine is \<=1.5.|GMT Ratio|0.99|||||TWO_SIDED|0.95|0.87|1.12|||||The comparison is done using adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group and the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when co-administered with the FLU vaccine compared to the RSVPreF3 OA vaccine administered alone, in terms of RSV-A neutralizing antibody titers, at 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group).||1.12|0.87|
71082715|NCT05568797|141672430|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the GMT ratio (Control group divided by Co-Ad group) for RSV-B neutralizing antibody vaccine is \<=1.5.|GMT Ratio|1.16|||||TWO_SIDED|0.95|1.03|1.3|||||The comparison is done using adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when co-administered with the FLU vaccine compared to the RSVPreF3 OA vaccine administered alone, in terms of RSV-B neutralizing antibody titers, at 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the CoAd Group and Day 61 for the Control Group).||1.30|1.03|
71082716|NCT05568797|141672431|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|10.25|||||TWO_SIDED|0.95|3.5|16.9||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu A/Darwin/6/2021 H3N2 strain at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||16.90|3.50|
71082717|NCT05568797|141672431|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|1.66|||||TWO_SIDED|0.95|-5.16|8.47||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu A/Victoria/2570/2019 H1N1 strain at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||8.47|-5.16|
71121553|NCT00468845|141749039|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7916||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.7916
70855750|NCT02880956|141198404|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|7.99|||TWO_SIDED|||||||||Week 96||||
71121554|NCT00468845|141749039|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3682||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.3682
71121555|NCT00468845|141749039|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1419||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.1419
71121556|NCT00468845|141749040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3323||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.3323
71121557|NCT00468845|141749040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5662||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.5662
71121558|NCT00468845|141749040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9538||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.9538
71121559|NCT00468845|141749040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4592||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.4592
71121560|NCT00468845|141749040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4793||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.4793
71121561|NCT00468845|141749040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8517||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.8517
71121562|NCT00468845|141749040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1829||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.1829
71121563|NCT00468845|141749040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3544||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.3544
71121564|NCT00468845|141749040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1718||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 6 PS||||0.1718
71121565|NCT00468845|141749040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5078||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 6 PS||||0.5078
71121566|NCT00468845|141749040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2443||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7 PS||||0.2443
71121567|NCT00468845|141749040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8296||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7 PS||||0.8296
71121568|NCT00468845|141749040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3243||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS (Average)||||0.3243
71121569|NCT00468845|141749040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3755||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS (Average)||||0.3755
71121570|NCT00468845|141749040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9584||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS (Average)||||0.9584
71121571|NCT00468845|141749040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1187||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS (Average)||||0.1187
71121572|NCT00468845|141749040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7915||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS (Average)||||0.7915
71121573|NCT00468845|141749040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0703||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS (Average)||||0.0703
71121574|NCT00468845|141749041|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1975||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge;||||0.1975
71121575|NCT00468845|141749041|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2784||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge;||||0.2784
71121576|NCT00468845|141749041|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0271||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.0271
71121577|NCT00468845|141749041|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0881||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.0881
71121578|NCT00468845|141749041|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0159||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.0159
71121579|NCT00468845|141749041|SUPERIORITY_OR_OTHER_LEGACY|||||||0.187||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.1870
71121580|NCT00468845|141749041|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1752||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.1752
71121581|NCT00468845|141749041|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6923||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.6923
71121582|NCT00468845|141749044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6295||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.6295
71121583|NCT00468845|141749044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.689||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.6890
71121584|NCT00468845|141749044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5094||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.5094
71121585|NCT00468845|141749044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8741||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.8741
71121586|NCT00468845|141749044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0214||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.0214
71121587|NCT00468845|141749044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9366||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.9366
71121588|NCT00468845|141749044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7833||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.7833
71121589|NCT00468845|141749044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2983||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.2983
71121590|NCT00468845|141749047|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6861||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers and salpingo-oophorectomy strata.||Surgery Day||||0.6861
71121591|NCT00468845|141749047|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9905||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Surgery Day||||0.9905
71121592|NCT00468845|141749048|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4264||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 1 PS||||0.4264
71121593|NCT00468845|141749048|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3045||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 1 PS||||0.3045
71121594|NCT00468845|141749049|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0714||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 2 PS||||0.0714
71121595|NCT00468845|141749049|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4455||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 2 PS||||0.4455
70855751|NCT02880956|141198404|SUPERIORITY||LS Mean of Difference|0.15|STANDARD_ERROR_OF_MEAN|1.095||0.891|TWO_SIDED|95.0|-2.004|2.304||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.304|-2.004|0.891
70855752|NCT02880956|141198404|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|8.28|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855753|NCT02880956|141198404|SUPERIORITY||LS Mean of Difference|0.55|STANDARD_ERROR_OF_MEAN|1.12||0.621|TWO_SIDED|95.0|-1.65|2.759||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.759|-1.650|0.621
70855754|NCT02880956|141198404|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|8.19|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855755|NCT02880956|141198405|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.019||0.147|TWO_SIDED|95.0|-0.01|0.064||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.064|-0.010|0.147
70855756|NCT02880956|141198405|SUPERIORITY||Effect size/pooled SD|-0.2|STANDARD_DEVIATION|0.14|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855757|NCT02880956|141198405|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.018||0.795|TWO_SIDED|95.0|-0.041|0.031||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.031|-0.041|0.795
70855758|NCT02880956|141198405|SUPERIORITY||Effect size/pooled SD|0.12|STANDARD_DEVIATION|0.147|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855759|NCT02880956|141198405|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.019||0.095|TWO_SIDED|95.0|-0.006|0.069||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.069|-0.006|0.095
70855760|NCT02880956|141198405|SUPERIORITY||Effect size/pooled SD|-0.24|STANDARD_DEVIATION|0.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
70855761|NCT02880956|141198405|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.025||0.39|TWO_SIDED|95.0|-0.028|0.072||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.072|-0.028|0.390
70855762|NCT02880956|141198405|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|0.18|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855763|NCT02880956|141198405|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.025||0.898|TWO_SIDED|95.0|-0.052|0.045||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.045|-0.052|0.898
70855764|NCT02880956|141198405|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|0.19|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
70855765|NCT02880956|141198405|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.026||0.8|TWO_SIDED|95.0|-0.044|0.057||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.057|-0.044|0.800
70855766|NCT02880956|141198405|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|0.18|||TWO_SIDED|||||||||Week 48||||
70855767|NCT02880956|141198405|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.033||0.977|TWO_SIDED|95.0|-0.066|0.064||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.064|-0.066|0.977
71082718|NCT05568797|141672431|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|0.25|||||TWO_SIDED|0.95|-4.92|5.46||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu B/Austria/1359417/2021 Victoria at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||5.46|-4.92|
71082719|NCT05568797|141672431|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|0.79|||||TWO_SIDED|0.95|-4.54|6.17||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu B/Phuket/3073/2013 Yamagata strain at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||6.17|-4.54|
71082720|NCT02651337|141672442|OTHER|It is a one arm clinical study. No comparison between groups was made.|||||||||||||||||The study tested the hypothesis that the Alivio flusher could increase flow in occluded or sluggish flowing catheters. Analysis was made on the basis of the procedural results related to priming the flusher, connecting the flusher to the shunt, flushing the system by dome compression, the ability to refill the dome, and the ability to evacuate the dome.|||
71082721|NCT00869128|141672458|SUPERIORITY_OR_OTHER|||||||0.04|||||||ANOVA|The effect of Circadin was checked by means of 2 x 2 mixed design analysis of variance for repeated measurement.||ANOVA, The effect of Circadin was checked by means of 2 x 2 mixed design analysis of variance for repeated measurement.||||0.04
71082722|NCT02716584|141672492|SUPERIORITY||Effect size|0.41||||0.02|TWO_SIDED||||||ANCOVA|||Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of exercise sessions attended as a covariate.||||0.02
71082723|NCT02716584|141672493|SUPERIORITY||Effect size|0.35||||0.06|TWO_SIDED||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.06
71082724|NCT02716584|141672494|SUPERIORITY|||||||0.13|||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.13
71121596|NCT00468845|141749050|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7418||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 3 PS||||0.7418
71121597|NCT00468845|141749050|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5154||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 3 PS||||0.5154
70954304|NCT02917603|141411102|EQUIVALENCE|Null hypothesis is that there would be no mean difference between baseline and last measure between intervention and control groups with p\<.05|Mean Difference (Net)|0.12|||<|0.009|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis is that the mean differences between baseline and last measure in the PHQ- 9 score will not differ between groups. Study is powered a two-tailed test of significance, allowing the detection of a significant difference in either direction and the following assumptions: expected difference in PHQ-9 is 5 points, the documented clinically significant effect;78 (2) the variance of scores is 5.33; (3) error protection: α =.10, β = .20 and, (4) anticipated attrition of 15%||||<.009
71121598|NCT00468845|141749051|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6715||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 4 PS||||0.6715
71082725|NCT02716584|141672495|SUPERIORITY||Effect size|0.19||||0.73|TWO_SIDED|||||The analyses for cohorts 1 and 2 utilized the a priori endpoint assessment conducted 1-2 weeks after completion of training.|ANCOVA|The data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.73
71082726|NCT02716584|141672495|SUPERIORITY||Effect size|0.73||||0.33|TWO_SIDED|||||For cohort 3, positive affect was measured at baseline and a midpoint assessment.|ANCOVA|The data were analyzed using a 2 (groups) x 2 (time: baseline, midpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||.33
71082727|NCT02716584|141672496|SUPERIORITY||Effect size|-0.21||||0.62|TWO_SIDED|||||The analyses for cohorts 1 and 2 utilized the a priori endpoint assessment conducted 1-2 weeks after completion of training.|ANCOVA|The data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.62
71082728|NCT02716584|141672496|SUPERIORITY||Effect size|0.77||||0.23|TWO_SIDED|||||For cohort 3, positive affect was measured at a baseline and midpoint assessment.|ANCOVA|The data were analyzed using a 2 (groups) x 2 (time: baseline, midpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||.23
71082729|NCT02716584|141672497|SUPERIORITY||Effect size|0.02||||0.57|TWO_SIDED||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.57
71082730|NCT02716584|141672498|SUPERIORITY||Effect size|0.35||||0.12|TWO_SIDED||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.12
71121599|NCT00468845|141749051|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9013||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 4 PS||||0.9013
71121600|NCT00468845|141749052|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9126||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 5 PS||||0.9126
71121601|NCT00468845|141749052|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 5 PS||||1.0000
70855768|NCT02880956|141198405|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|0.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855769|NCT02880956|141198405|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.032||0.99|TWO_SIDED|95.0|-0.063|0.064||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.064|-0.063|0.990
71082731|NCT02716584|141672499|SUPERIORITY||Effect size|0.72||||0.07|TWO_SIDED||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.07
71082732|NCT02716584|141672500|SUPERIORITY||Effect size|0.0||||0.88|TWO_SIDED||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.88
71082733|NCT02716584|141672501|SUPERIORITY||Effect size|0.05||||0.86|TWO_SIDED||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.86
71082734|NCT00913081|141672514|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis is that quercetin, at any dose, does not attenuate niacin-induced increases in dermal blood flow. Because quercetin has not been used to inhibit flushing from niacin in humans, sample size could not be determined statistically. A sample size of 8 men and 8 women was expected to allow separate estimates of effect size, variability, and shape of distribution for men and women.||||0.5
70944351|NCT05324007|141388810|EQUIVALENCE|Estimated effect size was based on Liberman et al. (2017) that found a partial eta squared of .478 for the interaction between different-language and same-language conditions. Using G\*power using an alpha of .05, our target sample size of 30 per condition should provide 99.73% power to detect the main effect in the White-White and Black-Black condition and 99.99% power to detect the main effect in the Black-White condition.|partial eta squared|0.062|||<|0.05|TWO_SIDED||||||ANOVA|||We will examine whether looking time at affiliation will be greater when looking at Black-White interactions than at White-White or Black-Black interactions. That is, we will test if infants will be more surprised (look longer) by affiliation between different-race people interacting than same race people interacting. We will conduct a mixed ANOVA with conditions (Black-White, White-White, Black-Black) as a between-subject and test type (affiliation vs. disengagement) as within-subject factors.||||<.05
70855770|NCT02880956|141198405|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|0.24|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70855771|NCT02880956|141198405|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.033||0.944|TWO_SIDED|95.0|-0.063|0.067||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.067|-0.063|0.944
70855772|NCT02880956|141198405|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|0.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
70944352|NCT00510146|141388829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15||||0.018|TWO_SIDED|95.0|-3.93|-0.36||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in MADRS total score from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||-0.36|-3.93|0.018
71121602|NCT00468845|141749053|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1233||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Discharge||||0.1233
71121603|NCT00468845|141749053|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1666||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Discharge||||0.1666
71121604|NCT00468845|141749054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0361||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 7||||0.0361
71121605|NCT00468845|141749054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0797||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 7||||0.0797
71121606|NCT00468845|141749055|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0206||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 14||||0.0206
71121607|NCT00468845|141749055|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 14||||0.0011
71121608|NCT00468845|141749057|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3506||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours||||0.3506
71121609|NCT00468845|141749058|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0287||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 28||||0.0287
71121610|NCT00468845|141749058|SUPERIORITY_OR_OTHER_LEGACY|||||||0.227||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 28||||0.2270
71121611|NCT00468845|141749059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1872||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Medication Subscale at Discharge||||0.1872
71121612|NCT00468845|141749059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3994||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Medication Subscale at Discharge||||0.3994
71121613|NCT00468845|141749059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0422||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Medication Subscale at Day 28||||0.0422
71121614|NCT00468845|141749059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3647||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Medication Subscale at Day 28||||0.3647
71121615|NCT00468845|141749059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1729||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Characteristics at Discharge||||0.1729
71121616|NCT00468845|141749059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2234||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Characteristics at Discharge||||0.2234
71121617|NCT00468845|141749059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.095||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Characteristics at Day 28||||0.0950
71121618|NCT00468845|141749059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4345||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Characteristics at Day 28||||0.4345
71121619|NCT00468845|141749059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.284||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Efficacy at Discharge||||0.2840
71121620|NCT00468845|141749059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6404||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Efficacy at Discharge||||0.6404
71121621|NCT00468845|141749059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.055||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Efficacy at Day 28||||0.0550
71121622|NCT00468845|141749059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4531||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Efficacy at Day 28||||0.4531
71121623|NCT00468845|141749060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9712||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.9712
71121624|NCT00468845|141749060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0112||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.0112
71121625|NCT00468845|141749060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.0090
70855773|NCT02880956|141198405|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.042||0.942|TWO_SIDED|95.0|-0.079|0.085||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.085|-0.079|0.942
70855774|NCT02880956|141198405|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|0.28|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855775|NCT02880956|141198405|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.041||0.876|TWO_SIDED|95.0|-0.087|0.074||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.074|-0.087|0.876
70855776|NCT02880956|141198405|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|0.27|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
70855777|NCT02880956|141198405|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.043||0.163|TWO_SIDED|95.0|-0.024|0.143||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.143|-0.024|0.163
70855778|NCT02880956|141198405|SUPERIORITY||Effect size/pooled SD|-0.21|STANDARD_DEVIATION|0.28|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71082735|NCT00913081|141672514|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis is that quercetin, at any dose, does not attenuate niacin-induced increases in dermal blood flow.||||0.8
71082736|NCT00913081|141672514|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis is that quercetin, at any dose, does not attenuate niacin-induced increases in dermal blood flow.||||0.5
71121626|NCT00468845|141749060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.865||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.8650
71121627|NCT00468845|141749061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8914||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 1997 Discharge||||0.8914
71121628|NCT00468845|141749061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2214||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 1997 Discharge||||0.2214
71121629|NCT00468845|141749061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1008||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 1997 Day 28||||0.1008
71121630|NCT00468845|141749061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9135||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 1997 Day 28||||0.9135
71121631|NCT00468845|141749061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5609||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 2001 Discharge||||0.5609
71121632|NCT00468845|141749061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4047||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 2001 Discharge||||0.4047
71121633|NCT00468845|141749061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1663||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 2001 Day 28||||0.1663
71121634|NCT00468845|141749061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8364||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 2001 Day 28||||0.8364
71121635|NCT00468845|141749062|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7218||95.0|||||Log Rank|||Kaplan-Meier method was used for survival distribution estimation;||||0.7218
71121636|NCT00468845|141749062|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4425||95.0|||||Log Rank|||Kaplan-Meier method was used for survival distribution estimation;||||0.4425
71121637|NCT00468845|141749063|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7889||95.0|||||Log Rank|||Kaplan-Meier method was used for survival distribution estimation;||||0.7889
71121638|NCT00468845|141749063|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1565||95.0|||||Log Rank|||Kaplan-Meier method was used for survival distribution estimation;||||0.1565
71121639|NCT00468845|141749064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6211||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Total subscale||||0.6211
71121640|NCT00468845|141749064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3687||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Total subscale||||0.3687
71121641|NCT00468845|141749064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7078||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Burning Spontaneous subscale||||0.7078
71121642|NCT00468845|141749064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8696||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Burning Spontaneous subscale||||0.8696
71121643|NCT00468845|141749064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.432||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Pressing Spontaneous subscale||||0.4320
71121644|NCT00468845|141749064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8843||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Pressing Spontaneous subscale||||0.8843
71121645|NCT00468845|141749064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6215||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Paroxysmal pain subscale||||0.6215
71121646|NCT00468845|141749064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2722||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Paroxysmal pain subscale||||0.2722
71121647|NCT00468845|141749064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Evoked Pain subscale||||0.5500
71121648|NCT00468845|141749064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9942||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Evoked Pain subscale||||0.9942
71082737|NCT00511173|141672595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|STANDARD_DEVIATION|4.5|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Null hypothesis: there is no difference in warfarin dose (mg/wk) between pharmacist dosing and algorithm dosing. In order to gather all SNP groups, the power analysis resulted in \> 100 patients enrolled into each group.||||< 0.05
71082738|NCT02603211|141672600|OTHER||||||||||||||||||"We will obtain 20 tactile image data sets from the breast tumor patients. The tactile images will be converted to size and deformation index. Then these two parameters will be converted to the risk score. This is a small number of patients for statistically significance study. Therefore, we plan to use the Leave-One-Out-Cross-Validation (LOOCV) technique to validate the human test results to determine the performance of the device.~We obtain the Risk Score. Risk Score is a unit less numerical value, which can be used as a scale to classify the tumor as malignant and benign. Based on the calculated size of the tumor and measured deformation index, the breast tumors are classified as benign and malignant using scoring method. The risk score will range from 0 to 5, where 0 represents the benign and 5 represents the malignant tumor.~Comparing the Risk Score and the Pathology reports we obtain sensitivity, specificity and accuracy of the system."|||
71082739|NCT00758498|141672613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9|||<|0.0001|TWO_SIDED|95.0|2.07|3.71|||ANCOVA|Treatment was a factor and baseline value was a co-variate||||3.71|2.07|<0.0001
71082740|NCT00758498|141672613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.9|||<|0.0001|TWO_SIDED|95.0|6.06|7.69|||ANCOVA|Treatment was a factor and baseline value was a co-variate||||7.69|6.06|<0.0001
71082741|NCT00758498|141672614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.8341|TWO_SIDED|95.0|-0.2|0.25|||ANOVA|||||0.25|-0.20|0.8341
71082742|NCT00758498|141672614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.0441|TWO_SIDED|95.0|-0.5|-0.05|||ANCOVA|||||-0.05|-0.50|0.0441
71082743|NCT00758498|141672615|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71082744|NCT00758498|141672615|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71082745|NCT00758498|141672616|SUPERIORITY_OR_OTHER|||||||0.0012|||||||ANCOVA|Treatment comparisons made use of an analysis of covariance (ANCOVA) analysis with treatment as a factor and baseline value as a covariate||||||0.0012
71082746|NCT00758498|141672616|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis by ANCOVA with treatment as a factor and the baseline value as a covariate||||||<0.0001
71082747|NCT00758498|141672617|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Analysis of treatment comparisons is based on an analysis of variance (ANCOVA) with treatment as a factor and the baseline value as covariate|ANCOVA|||||||<0.0001
71082748|NCT00758498|141672617|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is based on an ANCOVA with treatment as a factor and baseline value as a covariate||||||<0.0001
71082749|NCT00758498|141672618|SUPERIORITY_OR_OTHER|||||||0.0022|||||||ANCOVA|Analysis of treatment comparisons is based on analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate||||||0.0022
71082750|NCT00758498|141672618|SUPERIORITY_OR_OTHER|||||||0.0033|||||||ANCOVA|Analysis of treatment comparisons was based on ANCOVA with treatment as a factor and the baseline as a covariate||||||0.0033
71082751|NCT00758498|141672624|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is based on analysis of covariance (ANCOVA) with treatment as factor and baseline value as a covariate.||||||<0.0001
71082752|NCT00758498|141672624|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is based on ANCOVA with treatment as factor and baseline value as a covariate||||||<0.0001
71082753|NCT00758498|141672625|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is based on analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate||||||<0.0001
71082754|NCT00758498|141672625|SUPERIORITY_OR_OTHER||Least square mean||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is based on ANCOVA with treatment as a factor and the baseline value as a covariate||||||<0.0001
71082755|NCT00758498|141672626|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||||<0.0001
71082756|NCT00758498|141672626|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is from an ANCOVA with treatment as a factor and the baseline value as a covariate||||||<0.0001
71082757|NCT00758498|141672628|SUPERIORITY_OR_OTHER|||||||0.8262|||||||ANOVA|||||||0.8262
71082758|NCT00758498|141672628|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANOVA|||||||0.0040
71082759|NCT00758498|141672629|SUPERIORITY_OR_OTHER|||||||0.9595|||||||ANOVA|||||||0.9595
71082760|NCT00758498|141672629|SUPERIORITY_OR_OTHER||Least square mean|||||0.3539|||||||ANOVA|||||||0.3539
71082761|NCT00758498|141672630|SUPERIORITY_OR_OTHER|||||||0.1038|||||||ANOVA|||||||0.1038
71082762|NCT00758498|141672630|SUPERIORITY_OR_OTHER|||||||0.8112|||||||ANOVA|||||||0.8112
71082763|NCT01516736|141672639|EQUIVALENCE|The testing procedure was set up in a hierarchical structure, where first equivalence between LA-EP2006 and Neulasta® was assessed (margin ±1 day) and only if this was successfully established, non-inferiority between the two products was tested using a tighter margin of -0.6 days.|Mean Difference (Net)|-0.16||||0.05|TWO_SIDED|95.0|-0.4|0.08|||ANCOVA|The primary endpoints was analyzed with analysis of covariance (ANCOVA).||"The primary objective of the study was to compare LA-EP2006 and Neulasta in terms of the DSN in Cycle 1. It was to be shown in a hierarchical way:~1. that LA-EP2006 is equivalent (margin: ±1 day) to Neulasta® with respect to DSN duration in Cycle 1 and, if this was successfully established,~2. that LA-EP2006 is non-inferior (margin: -0.6 days) to Neulasta® with respect to DSN duration in Cycle 1."||0.08|-0.40|0.05
71082764|NCT01516736|141672639|NON_INFERIORITY|The testing procedure was set up in a hierarchical structure, where first equivalence between LA-EP2006 and Neulasta® was assessed (margin ±1 day) and only if this was successfully established, non-inferiority between the two products was tested using a tighter margin of -0.6 days.|Mean Difference (Net)|-0.16||||0.05|TWO_SIDED|95.0|-0.4|0.08|||ANCOVA|The primary endpoints was analyzed with analysis of covariance (ANCOVA).||"The primary objective of the study was to compare LA-EP2006 and Neulasta in terms of the DSN in Cycle 1. It was to be shown in a hierarchical way:~1. that LA-EP2006 is equivalent (margin: ±1 day) to Neulasta® with respect to DSN duration in Cycle 1 and, if this was successfully established,~2. that LA-EP2006 is non-inferior (margin: -0.6 days) to Neulasta® with respect to DSN duration in Cycle 1."||0.08|-0.40|0.05
71082765|NCT03365934|141672667|SUPERIORITY|||||||0.071225|||||||t-test, 2 sided|||||||0.071225
71082766|NCT03365934|141672667|SUPERIORITY|||||||0.092027|||||||t-test, 2 sided|||||||0.092027
71082767|NCT03365934|141672667|SUPERIORITY|||||||0.601716|||||||t-test, 2 sided|||||||0.601716
71082768|NCT03365934|141672667|SUPERIORITY|||||||0.639911|||||||t-test, 2 sided|||||||0.639911
71082769|NCT03365934|141672667|SUPERIORITY|||||||0.842476|||||||t-test, 2 sided|||||||0.842476
71082770|NCT03365934|141672667|SUPERIORITY|||||||0.999941|||||||t-test, 2 sided|||||||0.999941
71082771|NCT03365934|141672667|SUPERIORITY|||||||0.883479|||||||t-test, 2 sided|||||||0.883479
71082772|NCT03365934|141672667|SUPERIORITY|||||||0.782208|||||||t-test, 2 sided|||||||0.782208
71082773|NCT03365934|141672667|SUPERIORITY|||||||0.607134|||||||t-test, 2 sided|||||||0.607134
71121649|NCT00468845|141749064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0075||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Paresthesia/dysesthesia||||0.0075
70855779|NCT00576420|141198417|SUPERIORITY_OR_OTHER|||||||0.1564||90.0|||||Likelihood ratio chi-square test|||||||0.1564
71082774|NCT03365934|141672667|SUPERIORITY|||||||0.939549|||||||t-test, 2 sided|||||||0.939549
71082775|NCT03365934|141672667|SUPERIORITY|||||||0.86475|||||||t-test, 2 sided|||||||0.86475
71082776|NCT03365934|141672667|SUPERIORITY|||||||0.704759|||||||t-test, 2 sided|||||||0.704759
71082777|NCT03365934|141672667|SUPERIORITY|||||||0.999989|||||||t-test, 2 sided|||||||0.999989
71082778|NCT03365934|141672667|SUPERIORITY|||||||0.997568|||||||t-test, 2 sided|||||||0.997568
71082779|NCT03365934|141672667|SUPERIORITY|||||||0.999518|||||||t-test, 2 sided|||||||0.999518
71082780|NCT03365934|141672668|SUPERIORITY|||||||0.985332|||||||t-test, 2 sided|||||||0.985332
71082781|NCT03365934|141672668|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
71082782|NCT03365934|141672668|SUPERIORITY|||||||0.870459|||||||t-test, 2 sided|||||||0.870459
71082783|NCT03365934|141672668|SUPERIORITY|||||||0.004963|||||||t-test, 2 sided|||||||0.004963
71082784|NCT03365934|141672668|SUPERIORITY|||||||0.071935|||||||t-test, 2 sided|||||||0.071935
71082785|NCT03365934|141672668|SUPERIORITY|||||||0.988995|||||||t-test, 2 sided|||||||0.988995
71082786|NCT03365934|141672668|SUPERIORITY|||||||0.545378|||||||t-test, 2 sided|||||||0.545378
71082787|NCT03365934|141672668|SUPERIORITY|||||||0.000649|||||||t-test, 2 sided|||||||0.000649
71082788|NCT03365934|141672668|SUPERIORITY|||||||0.0146|||||||t-test, 2 sided|||||||0.014600
71082789|NCT03365934|141672668|SUPERIORITY|||||||0.854566|||||||t-test, 2 sided|||||||0.854566
71082790|NCT03365934|141672668|SUPERIORITY|||||||0.004322|||||||t-test, 2 sided|||||||0.004322
71082791|NCT03365934|141672668|SUPERIORITY|||||||0.0651|||||||t-test, 2 sided|||||||0.0651
71082792|NCT03365934|141672668|SUPERIORITY|||||||0.300536|||||||t-test, 2 sided|||||||0.300536
70855780|NCT00576420|141198419|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Likelihood ratio chi-square test|||||||0.060
70855781|NCT00576420|141198419|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Likelihood ratio chi-square test|||||||0.005
70855782|NCT00576420|141198420|SUPERIORITY_OR_OTHER|||||||0.123||95.0|||||Likelihood ratio chi-square test|||||||0.123
71082793|NCT03365934|141672668|SUPERIORITY|||||||0.753883|||||||t-test, 2 sided|||||||0.753883
71082794|NCT03365934|141672668|SUPERIORITY|||||||0.97621|||||||t-test, 2 sided|||||||0.97621
71082795|NCT03365934|141672669|SUPERIORITY|||||||0.027774|||||||t-test, 2 sided|||||||0.027774
71082796|NCT03365934|141672669|SUPERIORITY|||||||0.08431|||||||t-test, 2 sided|||||||0.08431
71082797|NCT03365934|141672669|SUPERIORITY|||||||0.049247|||||||t-test, 2 sided|||||||0.049247
71082798|NCT03365934|141672669|SUPERIORITY|||||||0.000126|||||||t-test, 2 sided|||||||0.000126
71082799|NCT03365934|141672669|SUPERIORITY|||||||0.010829|||||||t-test, 2 sided|||||||0.010829
71082800|NCT03365934|141672669|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71082801|NCT03365934|141672669|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71082802|NCT03365934|141672669|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71082803|NCT03365934|141672669|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71082804|NCT03365934|141672669|SUPERIORITY|||||||0.999533|||||||t-test, 2 sided|||||||0.999533
71082805|NCT03365934|141672669|SUPERIORITY|||||||0.4205363|||||||t-test, 2 sided|||||||0.4205363
71082806|NCT03365934|141672669|SUPERIORITY|||||||0.9802252|||||||t-test, 2 sided|||||||0.9802252
71121650|NCT00468845|141749064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1464||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Paresthesia/dysesthesia||||0.1464
70944353|NCT00510146|141388830|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with symptomatic response at endpoint from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.050
70944354|NCT00510146|141388831|SUPERIORITY_OR_OTHER|||||||0.367||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with symptomatic remission at any time from a Cochran-Mantel-Haenszel test using region as strata.|Cochran-Mantel-Haenszel|||||||0.367
70944355|NCT00510146|141388832|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.11||||0.008|TWO_SIDED|95.0|-0.2|-0.03||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in CGI-BP Mania score from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||-0.03|-0.20|0.008
70944356|NCT00510146|141388832|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.24||||0.037|TWO_SIDED|95.0|-0.47|-0.01||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in CGI-BP Depression score from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||-0.01|-0.47|0.037
70944357|NCT00510146|141388832|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.3||||0.008|TWO_SIDED|95.0|-0.53|-0.08||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in CGI-BP Overall score from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||-0.08|-0.53|0.008
70944358|NCT00510146|141388833|SUPERIORITY_OR_OTHER|||||||0.156||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with recovery from a Cochran-Mantel-Haenszel test using region as strata.|Cochran-Mantel-Haenszel|||||||0.156
70944359|NCT00510146|141388834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99|||<|0.001|TWO_SIDED|95.0|-1.56|-0.43||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||-0.43|-1.56|<0.001
70944360|NCT00510146|141388835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.21||||0.002|TWO_SIDED|95.0|-3.61|-0.81||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||-0.81|-3.61|0.002
70944361|NCT00510146|141388836|SUPERIORITY_OR_OTHER|||||||0.297||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with major depressive episode from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.297
70944362|NCT00510146|141388836|SUPERIORITY_OR_OTHER|||||||0.264||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with major depressive episode with melancholic features from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.264
71082807|NCT03365934|141672669|SUPERIORITY|||||||0.6845362|||||||t-test, 2 sided|||||||0.6845362
70855783|NCT00576420|141198420|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Likelihood ratio chi-square test|||||||0.026
70944363|NCT00510146|141388837|SUPERIORITY_OR_OTHER|||||||0.195||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with current hypomanic episode from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.195
70944364|NCT00510146|141388838|SUPERIORITY_OR_OTHER|||||||0.163||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with current psychotic disorders from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.163
70944365|NCT00510146|141388838|SUPERIORITY_OR_OTHER|||||||0.442||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with current mood disorders with psychotic features from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.442
70944366|NCT00510146|141388839|SUPERIORITY_OR_OTHER|||||||1||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with current alcohol dependence from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||1.00
70944367|NCT00510146|141388839|SUPERIORITY_OR_OTHER|||||||0.324||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with current alcohol abuse from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.324
71082808|NCT03365934|141672669|SUPERIORITY|||||||0.9992002|||||||t-test, 2 sided|||||||0.9992002
71082809|NCT03365934|141672669|SUPERIORITY|||||||0.8562779|||||||t-test, 2 sided|||||||0.8562779
70855784|NCT00576420|141198421|SUPERIORITY_OR_OTHER|||||||0.929||95.0|||||Likelihood ratio chi-square test|||||||0.929
70855785|NCT00576420|141198421|SUPERIORITY_OR_OTHER|||||||0.228||95.0|||||Likelihood ratio chi-square test|||||||0.228
70855786|NCT00576420|141198423|SUPERIORITY_OR_OTHER|||||||0.234||95.0|||||Likelihood ratio chi-square test|||||||0.234
70944368|NCT00510146|141388841|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with emergence of mania at endpoint from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.031
70855787|NCT00576420|141198423|SUPERIORITY_OR_OTHER|||||||0.955||95.0|||||Likelihood ratio chi-square test|||||||0.955
70855788|NCT00576420|141198424|SUPERIORITY_OR_OTHER|||||||0.106||95.0|||||Likelihood ratio chi-square test|||||||0.106
70855789|NCT00576420|141198424|SUPERIORITY_OR_OTHER|||||||0.243||95.0|||||Likelihood ratio chi-square test|||||||0.243
70855790|NCT00576420|141198424|SUPERIORITY_OR_OTHER|||||||0.127||95.0|||||Likelihood ratio chi-square test|||||||0.127
70855791|NCT00576420|141198425|SUPERIORITY_OR_OTHER|||||||0.257||95.0|||||Likelihood ratio chi-square test|||||||0.257
70855792|NCT00576420|141198425|SUPERIORITY_OR_OTHER|||||||0.096||95.0|||||Likelihood ratio chi-square test|||||||0.096
70855793|NCT00576420|141198425|SUPERIORITY_OR_OTHER|||||||0.127||95.0|||||Likelihood ratio chi-square test|||||||0.127
70855794|NCT01502332|141198448|SUPERIORITY_OR_OTHER|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
70855795|NCT01502332|141198449|SUPERIORITY_OR_OTHER|||||||0.014|||||||Log Rank|||||||0.014
70855796|NCT01502332|141198450|SUPERIORITY_OR_OTHER|||||||0.037|||||||Log Rank|||||||0.037
70855797|NCT01502332|141198452|SUPERIORITY_OR_OTHER|||||||0.267|||||||Regression, Logistic|||||||0.267
70855798|NCT02656680|141198468|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U Test||||0.72
70855799|NCT02656680|141198469|SUPERIORITY|||||||0.31|||||||Chi-squared|||Chi square test comparing proportion retained in each condition.||||0.31
70855800|NCT02656680|141198470|SUPERIORITY|||||||0.69|||||||Chi-squared|||||||0.69
71082810|NCT03365934|141672670|SUPERIORITY|||||||0.0403539|||||||t-test, 2 sided|||||||0.0403539
71121651|NCT00468845|141749065|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9877||95.0|||||Cochran-Mantel-Haenszel|p-values are derived from CMH test adjusted for pooled centers and salpingo-oophorectomy strata||Incidence of chronic PS pain at Month 3 PS.||||0.9877
71121652|NCT00468845|141749065|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1334||95.0|||||Cochran-Mantel-Haenszel|p-values are derived from CMH test adjusted for pooled centers and salpingo-oophorectomy strata||Incidence of chronic PS pain at Month 3 PS.||||0.1334
71121653|NCT00468845|141749065|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3566||95.0|||||Cochran-Mantel-Haenszel|p-values are derived from CMH test adjusted for pooled centers and salpingo-oophorectomy strata||Incidence of chronic PS pain at Month 6 PS.||||0.3566
71121654|NCT00468845|141749065|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6262||95.0|||||Cochran-Mantel-Haenszel|p-values are derived from CMH test adjusted for pooled centers and salpingo-oophorectomy strata||Incidence of chronic PS pain at Month 6 PS.||||0.6262
71121655|NCT00468845|141749066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9463||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day;||||0.9463
71121656|NCT00468845|141749066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7347||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day;||||0.7347
71121657|NCT00468845|141749066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4132||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS;||||0.4132
71121658|NCT00468845|141749066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4929||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS;||||0.4929
70855801|NCT02656680|141198471|SUPERIORITY|||||||0.218|||||||ANOVA|||We compared mean percent weight loss from baseline across groups with a one-way ANOVA. One participant became pregnant and thus removed from the analysis. This analysis is exploratory given that this pilot study was not powered to detect weight loss differences between groups.||||0.218
70855802|NCT02656680|141198472|SUPERIORITY|||||||0.421|||||||ANOVA|||||||0.421
70855803|NCT00789074|141198478|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||||||0.14
71121659|NCT00468845|141749066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6003||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS;||||0.6003
71121660|NCT00468845|141749066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9343||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS;||||0.9343
71121661|NCT00468845|141749066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3838||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS;||||0.3838
71121662|NCT00468845|141749066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1351||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS;||||0.1351
71121663|NCT00468845|141749066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3343||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS;||||0.3343
71121664|NCT00468845|141749066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7948||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS;||||0.7948
70855804|NCT00789074|141198479|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|Changes were compared using repeated measures analysis of variance||||||<0.001
70855805|NCT00789074|141198480|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||F=16.60|ANOVA|Changes were compared using repeated measures analysis of variance||||||<0.001
70944369|NCT00510146|141388842|SUPERIORITY_OR_OTHER|||||||0.269||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with EPS symptoms (akathisia) at endpoint from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.269
70855806|NCT00789074|141198481|SUPERIORITY_OR_OTHER||||||<|0.04||95.0||||F=2.92|ANOVA|Changes were compared using repeated measures analysis of variance||||||<0.04
70855807|NCT00789074|141198482|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|Changes were compared using repeated measures analysis of variance||||||0.02
70954305|NCT02917603|141411103|EQUIVALENCE|Null hypothesis is there will be the mean differences between baseline scores will be the same between groups. Study powered after primary outcome measure.|Mean Difference (Net)|0.46|||<|0.21|TWO_SIDED||||||t-test, 2 sided|||||||<.21
71082811|NCT03365934|141672670|SUPERIORITY|||||||0.2953049|||||||t-test, 2 sided|||||||0.2953049
71121665|NCT00468845|141749066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.809||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS;||||0.8090
71121666|NCT00468845|141749066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4035||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS;||||0.4035
71121667|NCT00468845|141749066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6009||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.6009
71121668|NCT00468845|141749066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7597||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.7597
71082812|NCT03365934|141672670|SUPERIORITY|||||||0.290551|||||||t-test, 2 sided|||||||0.290551
71082813|NCT03365934|141672670|SUPERIORITY|||||||2.47e-05|||||||t-test, 2 sided|||||||0.0000247
71082814|NCT03365934|141672670|SUPERIORITY|||||||0.0133001|||||||t-test, 2 sided|||||||0.0133001
71082815|NCT03365934|141672670|SUPERIORITY|||||||1.67e-05|||||||t-test, 2 sided|||||||0.0000167
71082816|NCT03365934|141672670|SUPERIORITY|||||||2.12e-05|||||||t-test, 2 sided|||||||0.0000212
71082817|NCT03365934|141672670|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71082818|NCT03365934|141672670|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71082819|NCT03365934|141672670|SUPERIORITY|||||||0.99999995|||||||t-test, 2 sided|||||||0.99999995
71121669|NCT00468845|141749066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7804||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.7804
71121670|NCT00468845|141749066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0463||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.0463
71082820|NCT03365934|141672670|SUPERIORITY|||||||0.0792013|||||||t-test, 2 sided|||||||0.0792013
71082821|NCT03365934|141672670|SUPERIORITY|||||||0.870163|||||||t-test, 2 sided|||||||0.870163
71082822|NCT03365934|141672670|SUPERIORITY|||||||0.103828|||||||t-test, 2 sided|||||||0.103828
71082823|NCT03365934|141672670|SUPERIORITY|||||||0.900265|||||||t-test, 2 sided|||||||0.900265
71082824|NCT03365934|141672670|SUPERIORITY|||||||0.570015|||||||t-test, 2 sided|||||||0.570015
71082825|NCT03365934|141672671|SUPERIORITY|||||||0.882449|||||||t-test, 2 sided|||||||0.882449
71082826|NCT03365934|141672671|SUPERIORITY|||||||0.088558|||||||t-test, 2 sided|||||||0.088558
71082827|NCT03365934|141672671|SUPERIORITY|||||||0.081846|||||||t-test, 2 sided|||||||0.081846
71082828|NCT03365934|141672671|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71082829|NCT03365934|141672671|SUPERIORITY|||||||3.03e-05|||||||t-test, 2 sided|||||||0.0000303
71082830|NCT03365934|141672671|SUPERIORITY|||||||0.001817|||||||t-test, 2 sided|||||||0.001817
71082831|NCT03365934|141672671|SUPERIORITY|||||||0.001825|||||||t-test, 2 sided|||||||0.001825
71082832|NCT03365934|141672671|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71082833|NCT03365934|141672671|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71082834|NCT03365934|141672671|SUPERIORITY|||||||0.999999|||||||t-test, 2 sided|||||||0.999999
71121671|NCT00468845|141749066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4951||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.4951
71121672|NCT00468845|141749066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.303||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.3030
71121673|NCT00468845|141749066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0104||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.0104
71082835|NCT03365934|141672671|SUPERIORITY|||||||0.038836|||||||t-test, 2 sided|||||||0.038836
71082836|NCT03365934|141672671|SUPERIORITY|||||||0.184508|||||||t-test, 2 sided|||||||0.184508
71082837|NCT03365934|141672671|SUPERIORITY|||||||0.062829|||||||t-test, 2 sided|||||||0.062829
71082838|NCT03365934|141672671|SUPERIORITY|||||||0.253458|||||||t-test, 2 sided|||||||0.253458
71082839|NCT03365934|141672671|SUPERIORITY|||||||0.987798|||||||t-test, 2 sided|||||||0.987798
71082840|NCT03365934|141672672|SUPERIORITY|||||||0.516068|||||||t-test, 2 sided|||||||0.516068
71082841|NCT03365934|141672672|SUPERIORITY|||||||0.358412|||||||t-test, 2 sided|||||||0.358412
71082842|NCT03365934|141672672|SUPERIORITY|||||||0.834145|||||||t-test, 2 sided|||||||0.834145
71082843|NCT03365934|141672672|SUPERIORITY|||||||3.5e-05|||||||t-test, 2 sided|||||||0.000035
71082844|NCT03365934|141672672|SUPERIORITY|||||||0.000843|||||||t-test, 2 sided|||||||0.000843
71082845|NCT03365934|141672672|SUPERIORITY|||||||0.002997|||||||t-test, 2 sided|||||||0.002997
71082846|NCT03365934|141672672|SUPERIORITY|||||||0.051717|||||||t-test, 2 sided|||||||0.051717
71082847|NCT03365934|141672672|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71082848|NCT03365934|141672672|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71082849|NCT03365934|141672672|SUPERIORITY|||||||0.985602|||||||t-test, 2 sided|||||||0.985602
71082850|NCT03365934|141672672|SUPERIORITY|||||||0.046422|||||||t-test, 2 sided|||||||0.046422
71082851|NCT03365934|141672672|SUPERIORITY|||||||0.28061|||||||t-test, 2 sided|||||||0.28061
71121674|NCT00468845|141749066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6978||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.6978
71121675|NCT01689350|141749067|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.99|||<|0.01|TWO_SIDED|95.0|1.76|14.14|||Chi-squared|||Null hypothesis: there is no difference between the control group and experimental group in terms of frequency of leucopenia.(α=0.05） Chi-square test was applied to test the difference. The Chi-square value was 10.08 and the P-value was 0.0015, which indicated that the null hypothesis could be rejected.||14.14|1.76|<0.01
71082852|NCT03365934|141672672|SUPERIORITY|||||||0.011015|||||||t-test, 2 sided|||||||0.011015
71082853|NCT03365934|141672672|SUPERIORITY|||||||0.089156|||||||t-test, 2 sided|||||||0.089156
71082854|NCT03365934|141672672|SUPERIORITY|||||||0.963882|||||||t-test, 2 sided|||||||0.963882
71082855|NCT03365934|141672673|SUPERIORITY|||||||0.00526|||||||t-test, 2 sided|||||||0.00526
71082856|NCT03365934|141672673|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
71082857|NCT03365934|141672673|SUPERIORITY|||||||0.914409|||||||t-test, 2 sided|||||||0.914409
71082858|NCT03365934|141672673|SUPERIORITY|||||||0.013004|||||||t-test, 2 sided|||||||0.013004
71121676|NCT01689350|141749068|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.69|||<|0.05|TWO_SIDED|95.0|1.01|7.13|||Chi-squared|||||7.13|1.01|<0.05
71121677|NCT02076399|141749076|SUPERIORITY||Risk Difference (RD)|17.6||||0.0261|TWO_SIDED|95.0|7.2|28.1|||Fisher Exact|||||28.1|7.2|0.0261
71082859|NCT03365934|141672673|SUPERIORITY|||||||0.028517|||||||t-test, 2 sided|||||||0.028517
71082860|NCT03365934|141672673|SUPERIORITY|||||||0.001356|||||||t-test, 2 sided|||||||0.001356
71082861|NCT03365934|141672673|SUPERIORITY|||||||5.9e-05|||||||t-test, 2 sided|||||||0.000059
71082862|NCT03365934|141672673|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71121678|NCT02076399|141749081|SUPERIORITY||Risk Difference (RD)|-0.01||||0.6642|TWO_SIDED|95.0|-0.01|0.0||P-value from a two-sided two-sample t-test, testing for a difference in means between fostamatinib and placebo.|t-test, 2 sided|||||0.0|-0.01|0.6642
71082863|NCT03365934|141672673|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71082864|NCT03365934|141672673|SUPERIORITY|||||||0.859272|||||||t-test, 2 sided|||||||0.859272
71121679|NCT02076399|141749082|SUPERIORITY||Risk Difference (RD)|0.15||||0.3365|TWO_SIDED|95.0|-0.2|0.5||P-value from a two-sided two-sample t-test, testing for a difference in means between fostamatinib and placebo.|t-test, 2 sided|||||0.5|-0.2|0.3365
71121680|NCT00085254|141749085|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.4|TWO_SIDED|95.0|0.5|1.3|||Regression, Cox|||||1.3|0.5|0.4
70855808|NCT00789074|141198483|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||ANOVA|Changes were compared using repeated measures analysis of variance||||||0.97
71082865|NCT03365934|141672673|SUPERIORITY|||||||0.002821|||||||t-test, 2 sided|||||||0.002821
71082866|NCT03365934|141672673|SUPERIORITY|||||||0.007492|||||||t-test, 2 sided|||||||0.007492
71082867|NCT03365934|141672673|SUPERIORITY|||||||0.208803|||||||t-test, 2 sided|||||||0.208803
71082868|NCT03365934|141672673|SUPERIORITY|||||||0.341884|||||||t-test, 2 sided|||||||0.341884
71082869|NCT03365934|141672673|SUPERIORITY|||||||0.999531|||||||t-test, 2 sided|||||||0.999531
71082870|NCT03365934|141672674|SUPERIORITY|||||||0.066788|||||||t-test, 2 sided|||||||0.066788
71082871|NCT03365934|141672674|SUPERIORITY|||||||0.942653|||||||t-test, 2 sided|||||||0.942653
71082872|NCT03365934|141672674|SUPERIORITY|||||||0.893545|||||||t-test, 2 sided|||||||0.893545
71121681|NCT00085254|141749087|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39||||0.0001|TWO_SIDED|95.0|0.3|0.5||adjusted for age: p=.0003, kps: p=.004; and surgical procedure: p=.003|Log Rank|||Primary endpoint death - defined from histological diagnosis to death. we assume pt in the study will have overall failure rate of 0.56 per person-year of f/up, a 30% reduction compared to hazard rate of 0.8 per person-year in historical NABTT database. Expected hazard ratio is 0.7 and cohort will produce 63 events among total of 94 pt planned f/up. One-sided test, have 95% power to detect observed ratio of 0.7 at alpha level of 0.1, or we have 88% power at alpha of 0.5 statistical significant||0.5|0.3|0.0001
71121682|NCT04342689|141749092|SUPERIORITY|||||||0.99|||||||Chi-squared|||||||0.99
71121683|NCT04342689|141749093|SUPERIORITY|||||||0.52|||||||t-test, 2 sided|||||||0.52
71121684|NCT04342689|141749094|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
71121685|NCT01460407|141749095|SUPERIORITY_OR_OTHER||Ratio of geometric LS mean|1.28|||||TWO_SIDED|90.0|1.16|1.42|||||Ratio of LY2216684 and Clarithromycin to LY2216684|||1.42|1.16|
71082873|NCT03365934|141672674|SUPERIORITY|||||||0.165225|||||||t-test, 2 sided|||||||0.165225
71082874|NCT03365934|141672674|SUPERIORITY|||||||0.140475|||||||t-test, 2 sided|||||||0.140475
71082875|NCT03365934|141672674|SUPERIORITY|||||||0.002026|||||||t-test, 2 sided|||||||0.002026
71082876|NCT03365934|141672674|SUPERIORITY|||||||0.001916|||||||t-test, 2 sided|||||||0.001916
71082877|NCT03365934|141672674|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71082878|NCT03365934|141672674|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71082879|NCT03365934|141672674|SUPERIORITY|||||||0.999957|||||||t-test, 2 sided|||||||0.999957
71082880|NCT03365934|141672674|SUPERIORITY|||||||0.672573|||||||t-test, 2 sided|||||||0.672573
71082881|NCT03365934|141672674|SUPERIORITY|||||||0.630145|||||||t-test, 2 sided|||||||0.630145
71082882|NCT03365934|141672674|SUPERIORITY|||||||0.832757|||||||t-test, 2 sided|||||||0.832757
71082883|NCT03365934|141672674|SUPERIORITY|||||||0.803277|||||||t-test, 1 sided|||||||0.803277
71082884|NCT03365934|141672674|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
71082885|NCT03365934|141672675|SUPERIORITY|||||||0.943522|||||||t-test, 2 sided|||||||0.943522
71082886|NCT03365934|141672675|SUPERIORITY|||||||0.002376|||||||t-test, 2 sided|||||||0.002376
71082887|NCT03365934|141672675|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71082888|NCT03365934|141672675|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71082889|NCT03365934|141672675|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71082890|NCT03365934|141672675|SUPERIORITY|||||||0.061015|||||||t-test, 2 sided|||||||0.061015
71082891|NCT03365934|141672675|SUPERIORITY|||||||0.000211|||||||t-test, 2 sided|||||||0.000211
71082892|NCT03365934|141672675|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71082893|NCT03365934|141672675|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71082894|NCT03365934|141672675|SUPERIORITY|||||||0.412626|||||||t-test, 2 sided|||||||0.412626
70855809|NCT00528970|141198489|OTHER||Mean Difference (Final Values)|2.0||||0.944||||||Threshold for significance at 0.05 level.|Log Rank|||Analysis was performed using log-rank test stratified by surgery type and region for comparisons of survival distributions for active MOA versus Placebo group.||||0.944
70855810|NCT00528970|141198489|OTHER||Mean Difference (Final Values)|9.1||||0.208||||||Threshold for significance at 0.05 level.|Log Rank|||Analysis was performed using log-rank test stratified by surgery type and region for comparisons of survival distributions for active MOA versus Placebo group.||||0.208
70855811|NCT03860935|141198493|SUPERIORITY||||||<|0.0001|||||||Finkelstein-Schoenfeld Method|||||||<0.0001
70855812|NCT03860935|141198494|SUPERIORITY||Least Squares Mean Difference|39.64|STANDARD_ERROR_OF_MEAN|9.477|<|0.0001|TWO_SIDED|96.0|20.18|59.1|||Mixed Models Analysis|||LS means are from a MMRM model with treatment group, visit, randomization stratification factors of genotype, NT-proBNP level and eGFR level (as recorded in IXRS) and treatment group-by-visit interaction as factors, and baseline value as covariate. Missing measurements due to early discontinuation of study treatment and due to death were imputed using the Jump to Reference (J2R) method and sampling with replacement from the worst 5% of observed values, respectively, as specified in study SAP.||59.10|20.18|<0.0001
70855813|NCT03860935|141198495|SUPERIORITY||Least Squares Mean Difference|9.94|STANDARD_ERROR_OF_MEAN|2.024|<|0.0001|TWO_SIDED|96.0|5.79|14.1|||Mixed Models Analysis|||LS means are from a MMRM model with treatment group, visit, randomization stratification factors of genotype, NT-proBNP level and eGFR level (as recorded in IXRS) and treatment group-by-visit interaction as factors, and baseline value as covariate. Missing measurements due to early discontinuation of study treatment and due to death were imputed using the Jump to Reference (J2R) method and sampling with replacement from the worst 5% of observed values, respectively, as specified in study SAP.||14.10|5.79|<0.0001
70944370|NCT00510146|141388842|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with EPS symptoms (parkinsonism) at endpoint from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.736
71082895|NCT03365934|141672675|SUPERIORITY|||||||0.104388|||||||t-test, 2 sided|||||||0.104388
71082896|NCT03365934|141672675|SUPERIORITY|||||||0.197791|||||||t-test, 2 sided|||||||0.197791
71082897|NCT03365934|141672675|SUPERIORITY|||||||0.994413|||||||t-test, 2 sided|||||||0.994413
71082898|NCT03365934|141672675|SUPERIORITY|||||||0.999851|||||||t-test, 2 sided|||||||0.999851
71082899|NCT03365934|141672675|SUPERIORITY|||||||0.999621|||||||t-test, 2 sided|||||||0.999621
71082900|NCT03365934|141672676|SUPERIORITY|||||||0.193667|||||||t-test, 2 sided|||||||0.193667
71082901|NCT03365934|141672676|SUPERIORITY|||||||0.526573|||||||t-test, 2 sided|||||||0.526573
71082902|NCT03365934|141672676|SUPERIORITY|||||||0.898749|||||||t-test, 2 sided|||||||0.898749
71082903|NCT03365934|141672676|SUPERIORITY|||||||0.975044|||||||t-test, 2 sided|||||||0.975044
71082904|NCT03365934|141672676|SUPERIORITY|||||||0.760706|||||||t-test, 2 sided|||||||0.760706
71082905|NCT03365934|141672676|SUPERIORITY|||||||0.985237|||||||t-test, 2 sided|||||||0.985237
71082906|NCT03365934|141672676|SUPERIORITY|||||||0.837995|||||||t-test, 2 sided|||||||0.837995
71082907|NCT03365934|141672676|SUPERIORITY|||||||0.592697|||||||t-test, 2 sided|||||||0.592697
71082908|NCT03365934|141672676|SUPERIORITY|||||||0.912495|||||||t-test, 2 sided|||||||0.912495
71082909|NCT03365934|141672676|SUPERIORITY|||||||0.99245|||||||t-test, 2 sided|||||||0.99245
71082910|NCT03365934|141672676|SUPERIORITY|||||||0.925553|||||||t-test, 2 sided|||||||0.925553
71082911|NCT03365934|141672676|SUPERIORITY|||||||0.999171|||||||t-test, 2 sided|||||||0.999171
71082912|NCT03365934|141672676|SUPERIORITY|||||||0.999324|||||||t-test, 2 sided|||||||0.999324
71082913|NCT03365934|141672676|SUPERIORITY|||||||0.999913|||||||t-test, 2 sided|||||||0.999913
71082914|NCT03365934|141672676|SUPERIORITY|||||||0.990516|||||||t-test, 2 sided|||||||0.990516
71082915|NCT03365934|141672677|SUPERIORITY|||||||0.92106|||||||t-test, 2 sided|||||||0.92106
71082916|NCT03365934|141672677|SUPERIORITY|||||||0.976812|||||||t-test, 2 sided|||||||0.976812
71082917|NCT03365934|141672677|SUPERIORITY|||||||0.233992|||||||t-test, 2 sided|||||||0.233992
71082918|NCT03365934|141672677|SUPERIORITY|||||||0.007591|||||||t-test, 2 sided|||||||0.007591
71082919|NCT03365934|141672677|SUPERIORITY|||||||0.038958|||||||t-test, 2 sided|||||||0.038958
71082920|NCT03365934|141672677|SUPERIORITY|||||||0.99809|||||||t-test, 2 sided|||||||0.99809
71082921|NCT03365934|141672677|SUPERIORITY|||||||0.773028|||||||t-test, 2 sided|||||||0.773028
71082922|NCT03365934|141672677|SUPERIORITY|||||||0.135805|||||||t-test, 2 sided|||||||0.135805
71082923|NCT03365934|141672677|SUPERIORITY|||||||0.350556|||||||t-test, 2 sided|||||||0.350556
71082924|NCT03365934|141672677|SUPERIORITY|||||||0.61046|||||||t-test, 2 sided|||||||0.61046
71082925|NCT03365934|141672677|SUPERIORITY|||||||0.062163|||||||t-test, 2 sided|||||||0.062163
71082926|NCT03365934|141672677|SUPERIORITY|||||||0.203418|||||||t-test, 2 sided|||||||0.203418
71082927|NCT03365934|141672677|SUPERIORITY|||||||0.942304|||||||t-test, 2 sided|||||||0.942304
71082928|NCT03365934|141672677|SUPERIORITY|||||||0.995238|||||||t-test, 2 sided|||||||0.995238
71082929|NCT03365934|141672677|SUPERIORITY|||||||0.99858|||||||t-test, 2 sided|||||||0.99858
71082930|NCT03365934|141672678|SUPERIORITY|||||||0.998949|||||||t-test, 2 sided|||||||0.998949
71082931|NCT03365934|141672678|SUPERIORITY|||||||0.111084|||||||t-test, 2 sided|||||||0.111084
71082932|NCT03365934|141672678|SUPERIORITY|||||||0.456846|||||||t-test, 2 sided|||||||0.456846
71082933|NCT03365934|141672678|SUPERIORITY|||||||0.00062|||||||t-test, 2 sided|||||||0.00062
71082934|NCT03365934|141672678|SUPERIORITY|||||||0.006871|||||||t-test, 2 sided|||||||0.006871
71082935|NCT03365934|141672678|SUPERIORITY|||||||0.039407|||||||t-test, 2 sided|||||||0.039407
71082936|NCT03365934|141672678|SUPERIORITY|||||||0.245375|||||||t-test, 2 sided|||||||0.245375
71082937|NCT03365934|141672678|SUPERIORITY|||||||0.000113|||||||t-test, 2 sided|||||||0.000113
71082938|NCT03365934|141672678|SUPERIORITY|||||||0.001612|||||||t-test, 2 sided|||||||0.001612
71082939|NCT03365934|141672678|SUPERIORITY|||||||0.988067|||||||t-test, 2 sided|||||||0.988067
71082940|NCT03365934|141672678|SUPERIORITY|||||||0.599171|||||||t-test, 2 sided|||||||0.599171
71082941|NCT03365934|141672678|SUPERIORITY|||||||0.928722|||||||t-test, 2 sided|||||||0.928722
71082942|NCT03365934|141672678|SUPERIORITY|||||||0.256079|||||||t-test, 2 sided|||||||0.256079
71082943|NCT03365934|141672678|SUPERIORITY|||||||0.626498|||||||t-test, 2 sided|||||||0.626498
71082944|NCT03365934|141672678|SUPERIORITY|||||||0.988693|||||||t-test, 2 sided|||||||0.988693
71082945|NCT03365934|141672679|SUPERIORITY|||||||0.99916|||||||t-test, 2 sided|||||||0.99916
71121686|NCT01460407|141749096|SUPERIORITY_OR_OTHER||Ratio of geometric LS mean|1.21|||||TWO_SIDED|90.0|1.12|1.31|||||Ratio of LY2216684 and Clarithromycin to LY2216684|||1.31|1.12|
71121687|NCT01460407|141749097|SUPERIORITY_OR_OTHER||Median of paired differences|0.0||||0.7656|TWO_SIDED|90.0|-0.5|0.5|||Wilcoxon (Mann-Whitney)||LY2216684 and Clarithromycin minus (-) LY2216684|||0.50|-0.50|0.7656
71121688|NCT00844805|141749117|SUPERIORITY_OR_OTHER||Difference in Percentages|14.9|||=|0.0884|TWO_SIDED|95.0|-1.7|31.5|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||31.5|-1.7|=0.0884
70855814|NCT03860935|141198496|SUPERIORITY||Least Squares Mean Difference|7.1|STANDARD_ERROR_OF_MEAN|0.665|<|0.0001|TWO_SIDED|96.0|5.73|8.46|||Mixed Models Analysis|||LS means are from a MMRM model with treatment group, visit, randomization stratification factors of genotype, NT-proBNP level and eGFR level (as recorded in IXRS) and treatment group-by-visit interaction as factors, and baseline value as covariate. Missing measurements due to early discontinuation of study treatment and due to death were imputed using the Jump to Reference (J2R) method and sampling with replacement from the worst 5% of observed values, respectively, as specified in study SAP.||8.46|5.73|<0.0001
70855815|NCT03860935|141198497|SUPERIORITY||Relative Risk Reduction (%)|25.0||||0.0569|TWO_SIDED|||||Cochran-Mantel-Haenszel test is stratified by randomization stratification factors of genotype, NT-proBNP level and eGFR level as recorded in IXRS.|Cochran-Mantel-Haenszel|||||||0.0569
70855816|NCT01105065|141198524|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared, Corrected|||There would be no change in retinal vascular dysregulation after treatment with brimonidine||||<0.0001
71082946|NCT03365934|141672679|SUPERIORITY|||||||0.016246|||||||t-test, 2 sided|||||||0.016246
71082947|NCT03365934|141672679|SUPERIORITY|||||||0.289112|||||||t-test, 2 sided|||||||0.289112
71082948|NCT03365934|141672679|SUPERIORITY|||||||3.8e-05|||||||t-test, 2 sided|||||||0.000038
71082949|NCT03365934|141672679|SUPERIORITY|||||||0.014558|||||||t-test, 2 sided|||||||0.014558
71082950|NCT03365934|141672679|SUPERIORITY|||||||0.03731|||||||t-test, 2 sided|||||||0.03731
71082951|NCT03365934|141672679|SUPERIORITY|||||||0.465745|||||||t-test, 2 sided|||||||0.465745
71082952|NCT03365934|141672679|SUPERIORITY|||||||0.000112|||||||t-test, 2 sided|||||||0.000112
71082953|NCT03365934|141672679|SUPERIORITY|||||||0.034575|||||||t-test, 2 sided|||||||0.034575
70855817|NCT01105065|141198525|SUPERIORITY_OR_OTHER|||||||0.28|||||||paired t-test|||A paired t-test was used to determine if their was a statistically significant difference between the mean deviation of the frequency doubling perimetry in the RVD patients pre and post brimonidine treatment.||||0.28
71082954|NCT03365934|141672679|SUPERIORITY|||||||0.889597|||||||t-test, 2 sided|||||||0.889597
71082955|NCT03365934|141672679|SUPERIORITY|||||||0.726932|||||||t-test, 2 sided|||||||0.726932
71082956|NCT03365934|141672679|SUPERIORITY|||||||0.999998|||||||t-test, 2 sided|||||||0.999998
71082957|NCT03365934|141672679|SUPERIORITY|||||||0.130235|||||||t-test, 2 sided|||||||0.130235
71082958|NCT03365934|141672679|SUPERIORITY|||||||0.910989|||||||t-test, 2 sided|||||||0.910989
71082959|NCT03365934|141672679|SUPERIORITY|||||||0.616933|||||||t-test, 2 sided|||||||0.616933
71082960|NCT03365934|141672680|SUPERIORITY|||||||0.999952|||||||t-test, 2 sided|||||||0.999952
71082961|NCT03365934|141672680|SUPERIORITY|||||||0.421347|||||||t-test, 2 sided|||||||0.421347
71082962|NCT03365934|141672680|SUPERIORITY|||||||0.598141|||||||t-test, 2 sided|||||||0.598141
71082963|NCT03365934|141672680|SUPERIORITY|||||||0.000197|||||||t-test, 2 sided|||||||0.000197
71082964|NCT03365934|141672680|SUPERIORITY|||||||0.000115|||||||t-test, 2 sided|||||||0.000115
71082965|NCT03365934|141672680|SUPERIORITY|||||||0.511155|||||||t-test, 2 sided|||||||0.511155
71082966|NCT03365934|141672680|SUPERIORITY|||||||0.693868|||||||t-test, 2 sided|||||||0.693868
70855818|NCT04575597|141198535|OTHER|Difference in rates % and associated confidence intervals (CIs) were based on the Miettinen \& Nurminen method stratified by randomization strata. Unknown survival status at Day 29 was treated as failure.|Difference in Rates %|-4.1|||||TWO_SIDED|95.0|-12.2|2.5||||||||2.5|-12.2|
71082967|NCT03365934|141672680|SUPERIORITY|||||||0.000232|||||||t-test, 2 sided|||||||0.000232
71082968|NCT03365934|141672680|SUPERIORITY|||||||0.000133|||||||t-test, 2 sided|||||||0.000133
71082969|NCT03365934|141672680|SUPERIORITY|||||||0.999894|||||||t-test, 2 sided|||||||0.999894
71082970|NCT03365934|141672680|SUPERIORITY|||||||0.078046|||||||t-test, 2 sided|||||||0.078046
71082971|NCT03365934|141672680|SUPERIORITY|||||||0.054975|||||||t-test, 2 sided|||||||0.054975
71082972|NCT03365934|141672680|SUPERIORITY|||||||0.050132|||||||t-test, 2 sided|||||||0.050132
71082973|NCT03365934|141672680|SUPERIORITY|||||||0.034793|||||||t-test, 2 sided|||||||0.034793
71082974|NCT03365934|141672680|SUPERIORITY|||||||0.999993|||||||t-test, 2 sided|||||||0.999993
71082975|NCT03365934|141672681|SUPERIORITY|||||||0.997406|||||||t-test, 2 sided|||||||0.997406
71082976|NCT03365934|141672681|SUPERIORITY|||||||0.354187|||||||t-test, 2 sided|||||||0.354187
71082977|NCT03365934|141672681|SUPERIORITY|||||||0.883222|||||||t-test, 2 sided|||||||0.883222
71082978|NCT03365934|141672681|SUPERIORITY|||||||0.000412|||||||t-test, 2 sided|||||||0.000412
71082979|NCT03365934|141672681|SUPERIORITY|||||||0.000332|||||||t-test, 2 sided|||||||0.000332
71082980|NCT03365934|141672681|SUPERIORITY|||||||0.626878|||||||t-test, 2 sided|||||||0.626878
71082981|NCT03365934|141672681|SUPERIORITY|||||||0.984465|||||||t-test, 2 sided|||||||0.984465
71082982|NCT03365934|141672681|SUPERIORITY|||||||0.001845|||||||t-test, 2 sided|||||||0.001845
71082983|NCT03365934|141672681|SUPERIORITY|||||||0.001507|||||||t-test, 2 sided|||||||0.001507
71082984|NCT03365934|141672681|SUPERIORITY|||||||0.970029|||||||t-test, 2 sided|||||||0.970029
71082985|NCT03365934|141672681|SUPERIORITY|||||||0.19886|||||||t-test, 2 sided|||||||0.19886
71121689|NCT00844805|141749118|SUPERIORITY_OR_OTHER||Difference in Percentages|21.7|||=|0.0013|TWO_SIDED|95.0|11.0|32.5|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||32.5|11.0|=0.0013
71082986|NCT03365934|141672681|SUPERIORITY|||||||0.177549|||||||t-test, 2 sided|||||||0.177549
70855819|NCT04575597|141198535|OTHER|Difference in rates % and associated CIs were based on the Miettinen \& Nurminen method stratified by randomization strata. Unknown survival status at Day 29 was treated as failure.|Difference in Rates %|-1.5|||||TWO_SIDED|95.0|-9.9|6.2||||||||6.2|-9.9|
70855820|NCT04575597|141198535|OTHER|Difference in rates % and associated CIs were based on the Miettinen \& Nurminen method stratified by randomization strata. Unknown survival status at Day 29 was treated as failure.|Differences in Rates %|-1.3|||||TWO_SIDED|95.0|-9.6|6.4||||||||6.4|-9.6|
70855821|NCT04575597|141198535|SUPERIORITY|Difference in rates %, associated CIs, and p-value were based on the Miettinen \& Nurminen method stratified by randomization strata. Unknown survival status at Day 29 was treated as failure.|Difference in Rates %|-6.8||||0.0012|TWO_SIDED|95.0|-11.3|-2.4|||Miettinen & Nurminen|||||-2.4|-11.3|0.0012
70855822|NCT04575597|141198538|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.48|1.13||||||||1.13|0.48|
70855823|NCT04575597|141198538|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.46|1.08||||||||1.08|0.46|
71082987|NCT03365934|141672681|SUPERIORITY|||||||0.041698|||||||t-test, 2 sided|||||||0.041698
71082988|NCT03365934|141672681|SUPERIORITY|||||||0.036131|||||||t-test, 2 sided|||||||0.036131
70855824|NCT04575597|141198538|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.47|1.11||||||||1.11|0.47|
71082989|NCT03365934|141672681|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
71082990|NCT03365934|141672682|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
71082991|NCT03365934|141672682|SUPERIORITY|||||||0.317315|||||||t-test, 2 sided|||||||0.317315
71082992|NCT03365934|141672682|SUPERIORITY|||||||0.829352|||||||t-test, 2 sided|||||||0.829352
71121690|NCT00844805|141749119|SUPERIORITY_OR_OTHER||Difference in Percentages|18.1|||=|0.0004|TWO_SIDED|95.0|10.7|25.5|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||25.5|10.7|=0.0004
71121691|NCT00844805|141749120|SUPERIORITY_OR_OTHER||Difference in Percentages|10.0|||=|0.5005|TWO_SIDED|95.0|-11.7|31.7|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||31.7|-11.7|=0.5005
71121692|NCT00844805|141749121|SUPERIORITY_OR_OTHER||Difference in Percentages|-2.5|||=|1|TWO_SIDED|95.0|-14.9|9.9|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||9.9|-14.9|=1.0000
70855825|NCT04575597|141198538|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.92|1.18||||||||1.18|0.92|
70855826|NCT04575597|141198539|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|0.8|2.76||||||||2.76|0.80|
71082993|NCT03365934|141672682|SUPERIORITY|||||||0.010561|||||||t-test, 2 sided|||||||0.010561
70855827|NCT04575597|141198539|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.69|2.09||||||||2.09|0.69|
70855828|NCT04575597|141198539|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.54|1.62||||||||1.62|0.54|
70855829|NCT04575597|141198539|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.95|1.33||||||||1.33|0.95|
71082994|NCT03365934|141672682|SUPERIORITY|||||||0.001099|||||||t-test, 2 sided|||||||0.001099
71082995|NCT03365934|141672682|SUPERIORITY|||||||0.175148|||||||t-test, 2 sided|||||||0.175148
71082996|NCT03365934|141672682|SUPERIORITY|||||||0.728796|||||||t-test, 2 sided|||||||0.728796
71082997|NCT03365934|141672682|SUPERIORITY|||||||0.001992|||||||t-test, 2 sided|||||||0.001992
71082998|NCT03365934|141672682|SUPERIORITY|||||||0.000113|||||||t-test, 2 sided|||||||0.000113
71082999|NCT03365934|141672682|SUPERIORITY|||||||0.974567|||||||t-test, 2 sided|||||||0.974567
71083000|NCT03365934|141672682|SUPERIORITY|||||||0.668933|||||||t-test, 2 sided|||||||0.668933
71083001|NCT03365934|141672682|SUPERIORITY|||||||0.239446|||||||t-test, 2 sided|||||||0.239446
71083002|NCT03365934|141672682|SUPERIORITY|||||||0.283848|||||||t-test, 2 sided|||||||0.283848
71083003|NCT03365934|141672682|SUPERIORITY|||||||0.06829|||||||t-test, 2 sided|||||||0.06829
71083004|NCT03365934|141672682|SUPERIORITY|||||||0.979516|||||||t-test, 2 sided|||||||0.979516
71083005|NCT03365934|141672683|SUPERIORITY|||||||0.996522|||||||t-test, 2 sided|||||||0.996522
71083006|NCT03365934|141672683|SUPERIORITY|||||||0.875832|||||||t-test, 2 sided|||||||0.875832
71083007|NCT03365934|141672683|SUPERIORITY|||||||0.938|||||||t-test, 2 sided|||||||0.938
71083008|NCT03365934|141672683|SUPERIORITY|||||||0.038527|||||||t-test, 2 sided|||||||0.038527
71083009|NCT03365934|141672683|SUPERIORITY|||||||0.018334|||||||t-test, 2 sided|||||||0.018334
71083010|NCT03365934|141672683|SUPERIORITY|||||||0.512209|||||||t-test, 2 sided|||||||0.512209
71083011|NCT03365934|141672683|SUPERIORITY|||||||0.665529|||||||t-test, 2 sided|||||||0.665529
71083012|NCT03365934|141672683|SUPERIORITY|||||||0.002257|||||||t-test, 2 sided|||||||0.002257
71083013|NCT03365934|141672683|SUPERIORITY|||||||0.000728|||||||t-test, 2 sided|||||||0.000728
71083014|NCT03365934|141672683|SUPERIORITY|||||||0.999993|||||||t-test, 2 sided|||||||0.999993
71083015|NCT03365934|141672683|SUPERIORITY|||||||0.417914|||||||t-test, 2 sided|||||||0.417914
71121693|NCT00844805|141749122|SUPERIORITY_OR_OTHER||Difference in Percentages|0.0|||=|1|TWO_SIDED|95.0|-6.8|6.8|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||6.8|-6.8|=1.0000
71121694|NCT00844805|141749123|SUPERIORITY_OR_OTHER||||||=|0.3802||95.0|||||Log Rank|||||||=0.3802
71083016|NCT03365934|141672683|SUPERIORITY|||||||0.277469|||||||t-test, 2 sided|||||||0.277469
71083017|NCT03365934|141672683|SUPERIORITY|||||||0.385419|||||||t-test, 2 sided|||||||0.385419
71083018|NCT03365934|141672683|SUPERIORITY|||||||0.257647|||||||t-test, 2 sided|||||||0.257647
71083019|NCT03365934|141672683|SUPERIORITY|||||||0.999897|||||||t-test, 2 sided|||||||0.999897
71083020|NCT03365934|141672684|SUPERIORITY|||||||0.862516|||||||t-test, 2 sided|||||||0.862516
71083021|NCT03365934|141672684|SUPERIORITY|||||||0.00473|||||||t-test, 2 sided|||||||0.00473
70855830|NCT04575597|141198540|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.62|1.46||||||||1.46|0.62|
70855831|NCT04575597|141198540|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.75|1.79||||||||1.79|0.75|
71083022|NCT03365934|141672684|SUPERIORITY|||||||0.085238|||||||t-test, 2 sided|||||||0.085238
71083023|NCT03365934|141672684|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70855832|NCT04575597|141198540|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.45|1.07||||||||1.07|0.45|
70944371|NCT00510146|141388843|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-standing systolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.146
71083024|NCT03365934|141672684|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71083025|NCT03365934|141672684|SUPERIORITY|||||||0.168409|||||||t-test, 2 sided|||||||0.168409
71083026|NCT03365934|141672684|SUPERIORITY|||||||0.652654|||||||t-test, 2 sided|||||||0.652654
71083027|NCT03365934|141672684|SUPERIORITY|||||||0.001436|||||||t-test, 2 sided|||||||0.001436
71083028|NCT03365934|141672684|SUPERIORITY|||||||0.000235|||||||t-test, 2 sided|||||||0.000235
71083029|NCT03365934|141672684|SUPERIORITY|||||||0.974842|||||||t-test, 2 sided|||||||0.974842
71083030|NCT03365934|141672684|SUPERIORITY|||||||0.557877|||||||t-test, 2 sided|||||||0.557877
71083031|NCT03365934|141672684|SUPERIORITY|||||||0.277244|||||||t-test, 2 sided|||||||0.277244
71083032|NCT03365934|141672684|SUPERIORITY|||||||0.195527|||||||t-test, 2 sided|||||||0.195527
71083033|NCT03365934|141672684|SUPERIORITY|||||||0.070843|||||||t-test, 2 sided|||||||0.070843
71083034|NCT03365934|141672684|SUPERIORITY|||||||0.997565|||||||t-test, 2 sided|||||||0.997565
71083035|NCT03365934|141672685|SUPERIORITY|||||||0.016628|||||||t-test, 2 sided|||||||0.016628
71083036|NCT03365934|141672685|SUPERIORITY|||||||0.217862|||||||t-test, 2 sided|||||||0.217862
70855833|NCT04575597|141198540|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.93|1.23||||||||1.23|0.93|
70944372|NCT00510146|141388843|SUPERIORITY_OR_OTHER|||||||0.249||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-sitting systolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.249
71083037|NCT03365934|141672685|SUPERIORITY|||||||0.812915|||||||t-test, 2 sided|||||||0.812915
71083038|NCT03365934|141672685|SUPERIORITY|||||||0.999971|||||||t-test, 2 sided|||||||0.999971
71083039|NCT03365934|141672685|SUPERIORITY|||||||0.275557|||||||t-test, 2 sided|||||||0.275557
71083040|NCT03365934|141672685|SUPERIORITY|||||||0.870124|||||||t-test, 2 sided|||||||0.870124
71083041|NCT03365934|141672685|SUPERIORITY|||||||0.380144|||||||t-test, 2 sided|||||||0.380144
71083042|NCT03365934|141672685|SUPERIORITY|||||||0.029518|||||||t-test, 2 sided|||||||0.029518
71083043|NCT03365934|141672685|SUPERIORITY|||||||0.815476|||||||t-test, 2 sided|||||||0.815476
71083044|NCT03365934|141672685|SUPERIORITY|||||||0.944307|||||||t-test, 2 sided|||||||0.944307
71083045|NCT03365934|141672685|SUPERIORITY|||||||0.313389|||||||t-test, 2 sided|||||||0.313389
71083046|NCT03365934|141672685|SUPERIORITY|||||||0.999996|||||||t-test, 2 sided|||||||0.999996
71083047|NCT03365934|141672685|SUPERIORITY|||||||0.894272|||||||t-test, 2 sided|||||||0.894272
71083048|NCT03365934|141672685|SUPERIORITY|||||||0.969093|||||||t-test, 2 sided|||||||0.969093
71083049|NCT03365934|141672685|SUPERIORITY|||||||0.383434|||||||t-test, 2 sided|||||||0.383434
71083050|NCT03365934|141672686|SUPERIORITY|||||||0.393119|||||||t-test, 2 sided|||||||0.393119
71083051|NCT03365934|141672686|SUPERIORITY|||||||0.890335|||||||t-test, 2 sided|||||||0.890335
71083052|NCT03365934|141672686|SUPERIORITY|||||||0.021978|||||||t-test, 2 sided|||||||0.021978
71083053|NCT03365934|141672686|SUPERIORITY|||||||0.000983|||||||t-test, 2 sided|||||||0.000983
71083054|NCT03365934|141672686|SUPERIORITY|||||||0.006615|||||||t-test, 2 sided|||||||0.006615
71083055|NCT03365934|141672686|SUPERIORITY|||||||0.951883|||||||t-test, 2 sided|||||||0.951883
71083056|NCT03365934|141672686|SUPERIORITY|||||||0.692455|||||||t-test, 2 sided|||||||0.692455
71083057|NCT03365934|141672686|SUPERIORITY|||||||0.257254|||||||t-test, 2 sided|||||||0.257254
71083058|NCT03365934|141672686|SUPERIORITY|||||||0.530181|||||||t-test, 2 sided|||||||0.530181
71083059|NCT03365934|141672686|SUPERIORITY|||||||0.219274|||||||t-test, 2 sided|||||||0.219274
71083060|NCT03365934|141672686|SUPERIORITY|||||||0.029675|||||||t-test, 2 sided|||||||0.029675
71083061|NCT03365934|141672686|SUPERIORITY|||||||0.111454|||||||t-test, 2 sided|||||||0.111454
71083062|NCT03365934|141672686|SUPERIORITY|||||||0.995849|||||||t-test, 2 sided|||||||0.995849
70944373|NCT00510146|141388843|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-standing diastolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.146
71083063|NCT03365934|141672686|SUPERIORITY|||||||0.999994|||||||t-test, 2 sided|||||||0.999994
71083064|NCT03365934|141672686|SUPERIORITY|||||||0.998744|||||||t-test, 2 sided|||||||0.998744
71083065|NCT03365934|141672687|SUPERIORITY|||||||0.999858|||||||t-test, 2 sided|||||||0.999858
71083066|NCT03365934|141672687|SUPERIORITY|||||||0.215132|||||||t-test, 2 sided|||||||0.215132
71083067|NCT03365934|141672687|SUPERIORITY|||||||0.958812|||||||t-test, 2 sided|||||||0.958812
71083068|NCT03365934|141672687|SUPERIORITY|||||||0.00622|||||||t-test, 2 sided|||||||0.00622
71083069|NCT03365934|141672687|SUPERIORITY|||||||0.017733|||||||t-test, 2 sided|||||||0.017733
71083070|NCT03365934|141672687|SUPERIORITY|||||||0.330576|||||||t-test, 2 sided|||||||0.330576
70944374|NCT00510146|141388843|SUPERIORITY_OR_OTHER|||||||0.271||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-sitting diastolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.271
71083071|NCT03365934|141672687|SUPERIORITY|||||||0.990334|||||||t-test, 2 sided|||||||0.990334
70944375|NCT00510146|141388843|SUPERIORITY_OR_OTHER|||||||0.284||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-orthostatic change in systolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.284
71083072|NCT03365934|141672687|SUPERIORITY|||||||0.013025|||||||t-test, 2 sided|||||||0.013025
71083073|NCT03365934|141672687|SUPERIORITY|||||||0.034707|||||||t-test, 2 sided|||||||0.034707
71083074|NCT03365934|141672687|SUPERIORITY|||||||0.771698|||||||t-test, 2 sided|||||||0.771698
71083075|NCT03365934|141672687|SUPERIORITY|||||||0.790117|||||||t-test, 2 sided|||||||0.790117
71083076|NCT03365934|141672687|SUPERIORITY|||||||0.923224|||||||t-test, 2 sided|||||||0.923224
70855834|NCT04575597|141198541|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.62|1.83||||||||1.83|0.62|
70855835|NCT04575597|141198541|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.4|1.26||||||||1.26|0.40|
70944376|NCT00510146|141388843|SUPERIORITY_OR_OTHER|||||||0.067||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-orthostatic change in diastolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.067
70944377|NCT00510146|141388844|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in weight from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||<0.001
71083077|NCT03365934|141672687|SUPERIORITY|||||||0.112245|||||||t-test, 2 sided|||||||0.112245
71083078|NCT03365934|141672687|SUPERIORITY|||||||0.216229|||||||t-test, 2 sided|||||||0.216229
71083079|NCT03365934|141672687|SUPERIORITY|||||||0.999663|||||||t-test, 2 sided|||||||0.999663
71083080|NCT03365934|141672688|SUPERIORITY|||||||0.91874|||||||t-test, 2 sided|||||||0.91874
71083081|NCT03365934|141672688|SUPERIORITY|||||||0.013582|||||||t-test, 2 sided|||||||0.013582
71083082|NCT03365934|141672688|SUPERIORITY|||||||0.523284|||||||t-test, 2 sided|||||||0.523284
71083083|NCT03365934|141672688|SUPERIORITY|||||||0.000315|||||||t-test, 2 sided|||||||0.000315
71083084|NCT03365934|141672688|SUPERIORITY|||||||0.059485|||||||t-test, 2 sided|||||||0.059485
71083085|NCT03365934|141672688|SUPERIORITY|||||||0.15037|||||||t-test, 2 sided|||||||0.15037
71083086|NCT03365934|141672688|SUPERIORITY|||||||0.967277|||||||t-test, 2 sided|||||||0.967277
71083087|NCT03365934|141672688|SUPERIORITY|||||||0.008729|||||||t-test, 2 sided|||||||0.008729
71083088|NCT03365934|141672688|SUPERIORITY|||||||0.421603|||||||t-test, 2 sided|||||||0.421603
71083089|NCT03365934|141672688|SUPERIORITY|||||||0.647267|||||||t-test, 2 sided|||||||0.647267
71083090|NCT03365934|141672688|SUPERIORITY|||||||0.953645|||||||t-test, 2 sided|||||||0.953645
71083091|NCT03365934|141672688|SUPERIORITY|||||||0.987387|||||||t-test, 2 sided|||||||0.987387
71083092|NCT03365934|141672688|SUPERIORITY|||||||0.147361|||||||t-test, 2 sided|||||||0.147361
71083093|NCT03365934|141672688|SUPERIORITY|||||||0.930371|||||||t-test, 2 sided|||||||0.930371
71083094|NCT03365934|141672688|SUPERIORITY|||||||0.6094|||||||t-test, 2 sided|||||||0.6094
71083095|NCT03365934|141672689|SUPERIORITY|||||||0.99253|||||||t-test, 2 sided|||||||0.99253
71083096|NCT03365934|141672689|SUPERIORITY|||||||0.795279|||||||t-test, 2 sided|||||||0.795279
71083097|NCT03365934|141672689|SUPERIORITY|||||||0.855067|||||||t-test, 2 sided|||||||0.855067
71083098|NCT03365934|141672689|SUPERIORITY|||||||0.003915|||||||t-test, 2 sided|||||||0.003915
71083099|NCT03365934|141672689|SUPERIORITY|||||||0.000221|||||||t-test, 2 sided|||||||0.000221
71083100|NCT03365934|141672689|SUPERIORITY|||||||0.97816|||||||t-test, 2 sided|||||||0.97816
71083101|NCT03365934|141672689|SUPERIORITY|||||||0.98972|||||||t-test, 2 sided|||||||0.98972
71083102|NCT03365934|141672689|SUPERIORITY|||||||0.01764|||||||t-test, 2 sided|||||||0.01764
71083103|NCT03365934|141672689|SUPERIORITY|||||||0.001185|||||||t-test, 2 sided|||||||0.001185
71083104|NCT03365934|141672689|SUPERIORITY|||||||0.999999|||||||t-test, 2 sided|||||||0.999999
71083105|NCT03365934|141672689|SUPERIORITY|||||||0.119961|||||||t-test, 2 sided|||||||0.119961
71083106|NCT03365934|141672689|SUPERIORITY|||||||0.013468|||||||t-test, 2 sided|||||||0.013468
71083107|NCT03365934|141672689|SUPERIORITY|||||||0.112192|||||||t-test, 2 sided|||||||0.112192
71083108|NCT03365934|141672689|SUPERIORITY|||||||0.013135|||||||t-test, 2 sided|||||||0.013135
71083109|NCT03365934|141672689|SUPERIORITY|||||||0.965966|||||||t-test, 2 sided|||||||0.965966
71083110|NCT03365934|141672690|SUPERIORITY|||||||0.968005|||||||t-test, 2 sided|||||||0.968005
71083111|NCT03365934|141672690|SUPERIORITY|||||||0.526293|||||||t-test, 2 sided|||||||0.526293
71083112|NCT03365934|141672690|SUPERIORITY|||||||0.994384|||||||t-test, 2 sided|||||||0.994384
71083113|NCT03365934|141672690|SUPERIORITY|||||||0.004967|||||||t-test, 2 sided|||||||0.004967
71121695|NCT00844805|141749124|SUPERIORITY_OR_OTHER||Difference in Percentages|-5.0|||=|0.6153|TWO_SIDED|95.0|-14.5|4.5|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||4.5|-14.5|=0.6153
71121696|NCT00844805|141749125|SUPERIORITY_OR_OTHER||Difference in Percentages|18.4|||=|0.0263|TWO_SIDED|95.0|2.5|34.3|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||34.3|2.5|=0.0263
71121697|NCT00844805|141749126|SUPERIORITY_OR_OTHER||Difference in Percentages|8.4|||=|0.3011|TWO_SIDED|95.0|-6.0|22.8|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||22.8|-6.0|=0.3011
71121698|NCT01741532|141749141|SUPERIORITY|||||||0.0761|||||||Mixed Models Analysis|||||||0.0761
71121699|NCT01741532|141749142|SUPERIORITY|||||||0.7279|||||||Mixed Models Analysis|||||||0.7279
71121700|NCT01741532|141749143|SUPERIORITY|||||||0.7228|||||||Mixed Models Analysis|||Comparison of treatment groups on change in score on UPDRS Part I||||0.7228
71121701|NCT01741532|141749143|SUPERIORITY|||||||0.3677|||||||Mixed Models Analysis|||Comparison of treatment groups on change in score on UPDRS Part II||||0.3677
71121702|NCT01741532|141749143|SUPERIORITY|||||||0.2182|||||||Mixed Models Analysis|||Comparison of treatment groups on change in score on UPDRS Part III||||0.2182
71121703|NCT01741532|141749143|SUPERIORITY|||||||0.1749|||||||Mixed Models Analysis|||Comparison of treatment groups on change in score on UPDRS Part VI||||0.1749
71083114|NCT03365934|141672690|SUPERIORITY|||||||0.000948|||||||t-test, 2 sided|||||||0.000948
71121704|NCT01741532|141749144|SUPERIORITY|||||||0.1524|||||||Mixed Models Analysis|||||||0.1524
71121705|NCT01741532|141749145|SUPERIORITY|||||||0.2026|||||||Mixed Models Analysis|||||||0.2026
71121706|NCT01741532|141749146|SUPERIORITY|||||||0.9759|||||||Mixed Models Analysis|||Patient self-report, total score||||0.9759
71121707|NCT01741532|141749146|SUPERIORITY|||||||0.5781|||||||Mixed Models Analysis|||Parent proxy-report, total score||||0.5781
71083115|NCT03365934|141672690|SUPERIORITY|||||||0.936394|||||||t-test, 2 sided|||||||0.936394
71083116|NCT03365934|141672690|SUPERIORITY|||||||0.999945|||||||t-test, 2 sided|||||||0.999945
71083117|NCT03365934|141672690|SUPERIORITY|||||||0.050032|||||||t-test, 2 sided|||||||0.050032
71083118|NCT03365934|141672690|SUPERIORITY|||||||0.01256|||||||t-test, 2 sided|||||||0.01256
71083119|NCT03365934|141672690|SUPERIORITY|||||||0.886978|||||||t-test, 2 sided|||||||0.886978
71083120|NCT03365934|141672690|SUPERIORITY|||||||0.391295|||||||t-test, 2 sided|||||||0.391295
71083121|NCT03365934|141672690|SUPERIORITY|||||||0.163678|||||||t-test, 2 sided|||||||0.163678
71083122|NCT03365934|141672690|SUPERIORITY|||||||0.047937|||||||t-test, 2 sided|||||||0.047937
71083123|NCT03365934|141672690|SUPERIORITY|||||||0.013231|||||||t-test, 2 sided|||||||0.013231
71083124|NCT03365934|141672690|SUPERIORITY|||||||0.996358|||||||t-test, 2 sided|||||||0.996358
71083125|NCT03365934|141672691|SUPERIORITY|||||||0.995862|||||||t-test, 2 sided|||||||0.995862
71083126|NCT03365934|141672691|SUPERIORITY|||||||0.223341|||||||t-test, 2 sided|||||||0.223341
71083127|NCT03365934|141672691|SUPERIORITY|||||||0.834338|||||||t-test, 2 sided|||||||0.834338
71083128|NCT03365934|141672691|SUPERIORITY|||||||0.030267|||||||t-test, 2 sided|||||||0.030267
71083129|NCT03365934|141672691|SUPERIORITY|||||||0.00104|||||||t-test, 2 sided|||||||0.00104
71083130|NCT03365934|141672691|SUPERIORITY|||||||0.377217|||||||t-test, 2 sided|||||||0.377217
71083131|NCT03365934|141672691|SUPERIORITY|||||||0.965547|||||||t-test, 2 sided|||||||0.965547
71083132|NCT03365934|141672691|SUPERIORITY|||||||0.052284|||||||t-test, 2 sided|||||||0.052284
71083133|NCT03365934|141672691|SUPERIORITY|||||||0.001348|||||||t-test, 2 sided|||||||0.001348
71083134|NCT03365934|141672691|SUPERIORITY|||||||0.927936|||||||t-test, 2 sided|||||||0.927936
71083135|NCT03365934|141672691|SUPERIORITY|||||||0.946487|||||||t-test, 2 sided|||||||0.946487
71083136|NCT03365934|141672691|SUPERIORITY|||||||0.327918|||||||t-test, 2 sided|||||||0.327918
71083137|NCT03365934|141672691|SUPERIORITY|||||||0.475038|||||||t-test, 2 sided|||||||0.475038
71083138|NCT03365934|141672691|SUPERIORITY|||||||0.060057|||||||t-test, 2 sided|||||||0.060057
71083139|NCT03365934|141672691|SUPERIORITY|||||||0.857177|||||||t-test, 2 sided|||||||0.857177
71083140|NCT03365934|141672692|SUPERIORITY|||||||0.999997|||||||t-test, 2 sided|||||||0.999997
71083141|NCT03365934|141672692|SUPERIORITY|||||||0.938793|||||||t-test, 2 sided|||||||0.938793
71083142|NCT03365934|141672692|SUPERIORITY|||||||0.965993|||||||t-test, 2 sided|||||||0.965993
71083143|NCT03365934|141672692|SUPERIORITY|||||||0.057803|||||||t-test, 2 sided|||||||0.057803
71083144|NCT03365934|141672692|SUPERIORITY|||||||0.022816|||||||t-test, 2 sided|||||||0.022816
71083145|NCT03365934|141672692|SUPERIORITY|||||||0.945179|||||||t-test, 2 sided|||||||0.945179
71083146|NCT03365934|141672692|SUPERIORITY|||||||0.972522|||||||t-test, 2 sided|||||||0.972522
71083147|NCT03365934|141672692|SUPERIORITY|||||||0.033704|||||||t-test, 2 sided|||||||0.033704
71083148|NCT03365934|141672692|SUPERIORITY|||||||0.010747|||||||t-test, 2 sided|||||||0.010747
71083149|NCT03365934|141672692|SUPERIORITY|||||||0.999999|||||||t-test, 2 sided|||||||0.999999
71083150|NCT03365934|141672692|SUPERIORITY|||||||0.385474|||||||t-test, 2 sided|||||||0.385474
71083151|NCT03365934|141672692|SUPERIORITY|||||||0.213798|||||||t-test, 2 sided|||||||0.213798
71083152|NCT03365934|141672692|SUPERIORITY|||||||0.388682|||||||t-test, 2 sided|||||||0.388682
71083153|NCT03365934|141672692|SUPERIORITY|||||||0.22386|||||||t-test, 2 sided|||||||0.22386
71083154|NCT03365934|141672692|SUPERIORITY|||||||0.999494|||||||t-test, 2 sided|||||||0.999494
71083155|NCT03365934|141672693|SUPERIORITY|||||||0.891244|||||||t-test, 2 sided|||||||0.891244
71083156|NCT03365934|141672693|SUPERIORITY|||||||0.022659|||||||t-test, 2 sided|||||||0.022659
71121708|NCT01741532|141749147|SUPERIORITY|||||||0.6323|||||||Mixed Models Analysis|||||||0.6323
71083157|NCT03365934|141672693|SUPERIORITY|||||||0.693615|||||||t-test, 2 sided|||||||0.693615
71083158|NCT03365934|141672693|SUPERIORITY|||||||0.000237|||||||t-test, 2 sided|||||||0.000237
71083159|NCT03365934|141672693|SUPERIORITY|||||||5e-06|||||||t-test, 2 sided|||||||0.000005
71083160|NCT03365934|141672693|SUPERIORITY|||||||0.352008|||||||t-test, 2 sided|||||||0.352008
71083161|NCT03365934|141672693|SUPERIORITY|||||||0.998761|||||||t-test, 2 sided|||||||0.998761
71083162|NCT03365934|141672693|SUPERIORITY|||||||0.017832|||||||t-test, 2 sided|||||||0.017832
71083163|NCT03365934|141672693|SUPERIORITY|||||||0.000974|||||||t-test, 2 sided|||||||0.000974
71083164|NCT03365934|141672693|SUPERIORITY|||||||0.638238|||||||t-test, 2 sided|||||||0.638238
71083165|NCT03365934|141672693|SUPERIORITY|||||||0.777423|||||||t-test, 2 sided|||||||0.777423
71083166|NCT03365934|141672693|SUPERIORITY|||||||0.249909|||||||t-test, 2 sided|||||||0.249909
71083167|NCT03365934|141672693|SUPERIORITY|||||||0.068196|||||||t-test, 2 sided|||||||0.068196
71083168|NCT03365934|141672693|SUPERIORITY|||||||0.005786|||||||t-test, 2 sided|||||||0.005786
71083169|NCT03365934|141672693|SUPERIORITY|||||||0.954163|||||||t-test, 2 sided|||||||0.954163
71083170|NCT03365934|141672695|SUPERIORITY||Mean Difference (Net)|-7.5|STANDARD_ERROR_OF_MEAN|2.851||0.009|TWO_SIDED|95.0|-13.1279|-1.8688|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 1||-1.8688|-13.1279|0.009
71083171|NCT03365934|141672695|SUPERIORITY||Mean Difference (Net)|-5.08|STANDARD_ERROR_OF_MEAN|2.851||0.077|TWO_SIDED|95.0|-10.7083|0.5508|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 1||0.5508|-10.7083|0.077
71083172|NCT03365934|141672695|SUPERIORITY||Mean Difference (Net)|-2.41|STANDARD_ERROR_OF_MEAN|2.851||0.399|TWO_SIDED|95.0|-8.0399|3.2192|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 1||3.2192|-8.0399|0.399
71083173|NCT03365934|141672695|SUPERIORITY||Mean Difference (Net)|0.72|STANDARD_ERROR_OF_MEAN|2.851||0.802|TWO_SIDED|95.0|-4.9144|6.3446|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 1||6.3446|-4.9144|0.802
71083174|NCT03365934|141672696|SUPERIORITY||Mean Difference (Net)|-11.37|STANDARD_ERROR_OF_MEAN|3.038|<|0.001|TWO_SIDED|95.0|-17.3738|-5.3723|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 2||-5.3723|-17.3738|<0.001
71083175|NCT03365934|141672696|SUPERIORITY||Mean Difference (Net)|-12.68|STANDARD_ERROR_OF_MEAN|3.038|<|0.001|TWO_SIDED|95.0|-18.6789|-6.6775|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 2||-6.6775|-18.6789|<0.001
71083176|NCT03365934|141672696|SUPERIORITY||Mean Difference (Net)|-1.96|STANDARD_ERROR_OF_MEAN|3.038||0.521|TWO_SIDED|95.0|-7.9571|4.0444|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 2||4.0444|-7.9571|0.521
71083177|NCT03365934|141672696|SUPERIORITY||Mean Difference (Net)|8.39|STANDARD_ERROR_OF_MEAN|3.038||0.006|TWO_SIDED|95.0|2.3925|14.394|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 2||14.3940|2.3925|0.006
71083178|NCT03365934|141672697|SUPERIORITY||Mean Difference (Net)|-31.83|STANDARD_ERROR_OF_MEAN|4.847|<|0.001|TWO_SIDED|95.0|-41.3967|-22.2538|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 3||-22.2538|-41.3967|<0.001
71083179|NCT03365934|141672697|SUPERIORITY||Mean Difference (Net)|-27.3|STANDARD_ERROR_OF_MEAN|4.847|<|0.001|TWO_SIDED|95.0|-36.8727|-17.7298|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 3||-17.7298|-36.8727|<0.001
71083180|NCT03365934|141672697|SUPERIORITY||Mean Difference (Net)|-13.71|STANDARD_ERROR_OF_MEAN|4.847||0.005|TWO_SIDED|95.0|-23.2784|-4.1355|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 3||-4.1355|-23.2784|0.005
71083181|NCT03365934|141672697|SUPERIORITY||Mean Difference (Net)|10.07|STANDARD_ERROR_OF_MEAN|4.847||0.039|TWO_SIDED|95.0|0.4969|19.6398|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 3||19.6398|0.4969|0.039
71083182|NCT03365934|141672698|SUPERIORITY||Mean Difference (Net)|-40.39|STANDARD_ERROR_OF_MEAN|5.39|<|0.001|TWO_SIDED|95.0|-51.0324|-29.7496|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 4||-29.7496|-51.0324|<0.001
71083183|NCT03365934|141672698|SUPERIORITY||Mean Difference (Net)|-37.84|STANDARD_ERROR_OF_MEAN|5.39|<|0.001|TWO_SIDED|95.0|-48.4787|-27.1959|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 4||-27.1959|-48.4787|<0.001
70855836|NCT04575597|141198541|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.41|||||TWO_SIDED|95.0|0.2|0.85||||||||0.85|0.20|
70855837|NCT04575597|141198541|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.86|1.18||||||||1.18|0.86|
71121709|NCT01741532|141749148|SUPERIORITY|||||||0|||||||Mixed Models Analysis|||||||0.0000
71121710|NCT02032641|141749163|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05|t-test, 1 sided|||||||<0.05
71121711|NCT02032641|141749163|SUPERIORITY_OR_OTHER||||||>|0.1||||||The threshold for significance is p\<0.05|t-test, 1 sided|||||||>0.10
71121712|NCT01822535|141749190|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||Between-group differences in percent changes in core body temperature from baseline values to after cool exposure were analyzed. Because individuals with tetraplegia have impaired thermoregulatory mechanisms, we hypothesized that their percent change in core body temperature would be significantly larger than that of able-bodied controls.||||<0.01
71121713|NCT01822535|141749191|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||ANOVA|||"Between-group comparisons of percent changes in Stroop Interference T-scores from baseline values to after cool exposure were analyzed.~We hypothesized that subjects with tetraplegia would have greater declines in cognitive performance after cool exposure than able-bodied controls."||||0.018
71121714|NCT01822535|141749192|SUPERIORITY_OR_OTHER|||||||0.0431|TWO_SIDED||||||ANOVA|||"Between-group comparisons of percent changes in Delayed Recall from baseline values to after cool exposure were analyzed.~We hypothesized that subjects with tetraplegia would have greater declines in cognitive performance after cool exposure than able-bodied controls."||||0.0431
71121715|NCT01822535|141749193|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||ANOVA|||"We hypothesized that administration of midodrine would attenuate the fall in core body temperature.~Within-group percent changes in core body temperature were analyzed to compare data from visit 1 (no drug) to visit 2 (drug)."||||0.30
71121716|NCT01071356|141749194|SUPERIORITY_OR_OTHER||Time averaged post-bline diff in diff|-0.006||||0.47|TWO_SIDED|95.0|-0.023|0.011|||Random Effects modeling||Stat Mixed Model: MI9 (Post - Bline) - MI1 (Post - Bline) taken across 2, 4, and 6 month follow-ups adjusted for gender, age, and # sessions attended.|Stat Mixed Model Estimated was: MI9 (Post - Bline) - MI1 (Post - Bline) taken across 2, 4, and 6 month follow-ups adjusted for gender, age, and # sessions attended. This was done because a statistical test of trend of the post-baseline effect across the 3 post interviews indicated a homogeneous post-baseline treatment effect across time for both MI1 and MI9 conditions.||.011|-.023|.47
71121717|NCT01071356|141749195|SUPERIORITY_OR_OTHER||Time averaged post-bline diff in diff|0.007||||0.034|TWO_SIDED|95.0|0.001|0.013|||Random effects model||Stat Mixed Model: MI9 (Post - Bline) - MI1 (Post - Bline) taken across 2, 4, and 6 month follow-ups adjusted for gender, age, and # sessions attended.|Stat Mixed Model Estimated was: MI9 (Post - Bline) - MI1 (Post - Bline) taken across 2, 4, and 6 month follow-ups adjusted for gender, age, and # sessions attended. This was done because a statistical test of trend of the post-baseline effect across the 3 post interviews indicated a homogeneous post-baseline treatment effect across time for both MI1 and MI9 conditions.||.013|.001|.034
71121718|NCT02278614|141749196|OTHER|The change from baseline in mean IOP on Day 84 for the contralateral eye,|Adjusted mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.57|0.43|||Mixed Models Analysis|||||0.43|-0.57|
71121719|NCT02278614|141749196|OTHER|The change from baseline in mean IOP on D42 for the worse eye|Adjusted mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|95.0|-0.69|0.31|||Mixed Models Analysis|||||0.31|-0.69|
71121720|NCT03582813|141749208|SUPERIORITY||MIXREG Estimate|4.27|STANDARD_ERROR_OF_MEAN|1.61|<|0.01|TWO_SIDED||||||Mixed Effects Random Regression|||This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in self-perceived Recovery and that this effect would be maintained overtime;||||<.01
71121721|NCT03582813|141749209|SUPERIORITY||MIXREG Estimate|0.9|STANDARD_ERROR_OF_MEAN|0.42||0.031|TWO_SIDED||||||Mixed Effects Random Regression|||This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in self-esteem that would be maintained longitudinally||||.031
71121722|NCT03582813|141749210|SUPERIORITY||MIXREG Estimate|0.12|STANDARD_ERROR_OF_MEAN|0.04|<|0.01|TWO_SIDED||||||Mixed Effects Random Regression|||This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in coping mastery that would be maintained longitudinally||||<0.01
71121723|NCT03582813|141749211|SUPERIORITY||MIXREG Estimate|0.29|STANDARD_ERROR_OF_MEAN|0.13||0.03|TWO_SIDED||||||Mixed Effects Random Regression|||This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in perceived autonomy support that would be maintained longitudinally||||0.030
71121724|NCT03582813|141749212|SUPERIORITY||Odds Ratio (OR)|2.19||||0.046|TWO_SIDED|95.0|1.01|4.74|||Regression, Logistic|||This mixed effects random regression analysis tested whether intervention participants would report greater likelihood of employment that would be maintained longitudinally||4.74|1.01|0.046
71121725|NCT03582813|141749213|SUPERIORITY||Odds Ratio (OR)|4.14|||<|0.01|TWO_SIDED|95.0|1.5|11.44|||Regression, Logistic|||This mixed effects random regression analysis tested whether intervention participants would report greater likelihood of enrollment in educational classes that would be maintained longitudinally||11.44|1.50|<0.01
71121726|NCT02558400|141749223|SUPERIORITY|To claim superiority PG324 had to be statistically superior to netarsudil and to latanoprost at all 9 of 9 primary efficacy timepoints|||||<|0.0001|||||||t-test, 2 sided|PG324 vs. netarsudil||||||<0.0001
71121727|NCT02558400|141749223|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|PG324 vs. latanoprost||||||<0.0001
71121728|NCT02230683|141749225|SUPERIORITY_OR_OTHER||within group change|-1.14|STANDARD_DEVIATION|4.57||0.257|TWO_SIDED|95.0|-3.16|0.89|||Paired t-test||within group change|Statistical Analysis for the mean change of the Hepatic Venous Pressure Gradient from Baseline to Day 28/EOT for the overall evaluable population treated with IDN-6556 25 mg twice daily||0.89|-3.16|0.257
71121729|NCT02230683|141749225|SUPERIORITY_OR_OTHER||within group change|1.9|STANDARD_DEVIATION|3.15||0.1174|TWO_SIDED|95.0|-0.52|4.32|||ANCOVA||within group change|Statistical Analysis for the mean change of the Hepatic Venous Pressure Gradient from Baseline to Day 28/EOT in the HVPG \< 12 mmHg subgroup||4.32|-0.52|0.1174
70855838|NCT04575597|141198542|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.32|1.34||||||||1.34|0.32|
70855839|NCT04575597|141198542|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.44|||||TWO_SIDED|95.0|0.76|2.71||||||||2.71|0.76|
70855840|NCT04575597|141198542|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.39|1.42||||||||1.42|0.39|
71083184|NCT03365934|141672698|SUPERIORITY||Mean Difference (Net)|-20.99|STANDARD_ERROR_OF_MEAN|5.39|<|0.001|TWO_SIDED|95.0|-31.6336|-10.3508|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 4||-10.3508|-31.6336|<0.001
71083185|NCT03365934|141672698|SUPERIORITY||Mean Difference (Net)|8.75|STANDARD_ERROR_OF_MEAN|5.39||0.106|TWO_SIDED|95.0|-1.8871|19.3957|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 4||19.3957|-1.8871|0.106
71083186|NCT03365934|141672699|SUPERIORITY||Mean Difference (Net)|-32.9|STANDARD_ERROR_OF_MEAN|5.276|<|0.001|TWO_SIDED|95.0|-43.3249|-22.4838|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 5||-22.4838|-43.3249|<0.001
71083187|NCT03365934|141672699|SUPERIORITY||Mean Difference (Net)|-27.31|STANDARD_ERROR_OF_MEAN|5.276|<|0.001|TWO_SIDED|95.0|-37.7279|-16.8868|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 5||-16.8868|-37.7279|<0.001
71083188|NCT03365934|141672699|SUPERIORITY||Mean Difference (Net)|-18.76|STANDARD_ERROR_OF_MEAN|5.276|<|0.001|TWO_SIDED|95.0|-29.1785|-8.3374|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 5||-8.3374|-29.1785|<0.001
71083189|NCT03365934|141672699|SUPERIORITY||Mean Difference (Net)|6.79|STANDARD_ERROR_OF_MEAN|5.276||0.2|TWO_SIDED|95.0|-3.6303|17.2107|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 5||17.2107|-3.6303|0.200
71083190|NCT03365934|141672700|SUPERIORITY||Mean Difference (Net)|-30.9|STANDARD_ERROR_OF_MEAN|4.371|<|0.001|TWO_SIDED|95.0|-39.5325|-22.265|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 6||-22.2650|-39.5325|<0.001
71083191|NCT03365934|141672700|SUPERIORITY||Mean Difference (Net)|-25.33|STANDARD_ERROR_OF_MEAN|4.371|<|0.001|TWO_SIDED|95.0|-33.9669|-16.6993|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 6||-16.6993|-33.9669|<0.001
71083192|NCT03365934|141672700|SUPERIORITY||Mean Difference (Net)|-20.63|STANDARD_ERROR_OF_MEAN|4.371|<|0.001|TWO_SIDED|95.0|-29.2588|-11.9912|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 6||-11.9912|-29.2588|<0.001
71083193|NCT03365934|141672700|SUPERIORITY||Mean Difference (Net)|4.27|STANDARD_ERROR_OF_MEAN|4.371||0.33|TWO_SIDED|95.0|-4.362|12.9055|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 6||12.9055|-4.3620|0.330
71083194|NCT03365934|141672701|SUPERIORITY||Mean Difference (Net)|-13.95|STANDARD_ERROR_OF_MEAN|3.754|<|0.001|TWO_SIDED|95.0|-21.368|-6.5419|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 7||-6.5419|-21.3680|<0.001
71083195|NCT03365934|141672701|SUPERIORITY||Mean Difference (Net)|-11.54|STANDARD_ERROR_OF_MEAN|3.754||0.002|TWO_SIDED|95.0|-18.9563|-4.1302|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 7||-4.1302|-18.9563|0.002
71083196|NCT03365934|141672701|SUPERIORITY||Mean Difference (Net)|-10.07|STANDARD_ERROR_OF_MEAN|3.754||0.008|TWO_SIDED|95.0|-17.4867|-2.6606|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 7||-2.6606|-17.4867|0.008
71083197|NCT03365934|141672701|SUPERIORITY||Mean Difference (Net)|6.87|STANDARD_ERROR_OF_MEAN|3.754||0.069|TWO_SIDED|95.0|-0.5447|14.2814|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 7||14.2814|-0.5447|0.069
71083198|NCT03365934|141672702|SUPERIORITY||Mean Difference (Net)|-2.76|STANDARD_ERROR_OF_MEAN|3.244||0.397|TWO_SIDED|95.0|-9.1631|3.6504|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 14||3.6504|-9.1631|0.397
71083199|NCT03365934|141672702|SUPERIORITY||Mean Difference (Net)|0.81|STANDARD_ERROR_OF_MEAN|3.244||0.804|TWO_SIDED|95.0|-5.6006|7.2129|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 14||7.2129|-5.6006|0.804
71083200|NCT03365934|141672702|SUPERIORITY||Mean Difference (Net)|-9.32|STANDARD_ERROR_OF_MEAN|3.244||0.005|TWO_SIDED|95.0|-15.7231|-2.9096|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 14||-2.9096|-15.7231|0.005
71083201|NCT03365934|141672702|SUPERIORITY||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|3.244||0.985|TWO_SIDED|95.0|-6.3452|6.4683|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 14||6.4683|-6.3452|0.985
70855841|NCT04575597|141198542|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.94|1.37||||||||1.37|0.94|
71083202|NCT03365934|141672704|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.044||0.348|TWO_SIDED|95.0|-0.129|0.0458|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 1||0.0458|-0.1290|0.348
71083203|NCT03365934|141672704|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.044||0.019|TWO_SIDED|95.0|-0.1904|-0.0178|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 1||-0.0178|-0.1904|0.019
70944378|NCT00510146|141388845|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in fasting glucose from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.179
70944379|NCT00510146|141388845|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in cholesterol from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||<0.001
70944380|NCT00510146|141388845|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in triglycerides from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.003
70944381|NCT00510146|141388845|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in LDL cholesterol from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||<0.001
70944382|NCT00510146|141388845|SUPERIORITY_OR_OTHER|||||||0.095||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in HDL cholesterol from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.095
71121730|NCT02230683|141749225|SUPERIORITY_OR_OTHER||within group change|-3.67|STANDARD_DEVIATION|4.05||0.0025|TWO_SIDED|95.0|-5.88|-1.46|||ANCOVA||within group change|Statistical Analysis for the mean change of the Hepatic Venous Pressure Gradient from Baseline to Day 28/EOT in the HVPG ≥ 12 mmHg subgroup||-1.46|-5.88|0.0025
71121731|NCT02230683|141749226|SUPERIORITY_OR_OTHER||within group change|-0.22||||0.026|TWO_SIDED|95.0|-0.42|-0.03|||ANCOVA|||Statistical Analysis for the mean change in log-transformed caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT for the overall evaluable population treated with IDN-6556 25 mg twice daily||-0.03|-0.42|0.026
71121732|NCT02230683|141749226|SUPERIORITY_OR_OTHER||within group change|-0.46||||0.001|TWO_SIDED|95.0|-0.72|-0.21|||ANCOVA|||Statistical Analysis for the mean change in log-transformed caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT in the HVPG \< 12 mmHg subgroup population treated with IDN-6556 25 mg twice daily||-0.21|-0.72|0.001
71121733|NCT02230683|141749226|SUPERIORITY_OR_OTHER||within group change|-0.04||||0.72|TWO_SIDED|95.0|-0.26|0.18|||ANCOVA|||Statistical Analysis for the median change in log-transformed caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT in the HVPG ≥ 12 mmHg subgroup population treated with IDN-6556 25 mg twice daily||0.18|-0.26|0.72
71121734|NCT02230683|141749227|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-21.0||||0.105|TWO_SIDED|95.0|-60.0|13.0|||Wilcoxon (Mann-Whitney)|||Statistical Analysis for the median change of caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT for the overall evaluable population treated with IDN-6556 25 mg twice daily||13|-60|0.105
70855842|NCT04575597|141198543|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.66|1.61||||||||1.61|0.66|
70944383|NCT00510146|141388846|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in albumin from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||0.001
70944384|NCT00510146|141388847|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in ALT/SGPT from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
70944385|NCT00510146|141388847|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in AST/SGOT from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||0.001
70944386|NCT00510146|141388847|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in GGT from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
71121735|NCT02230683|141749227|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-52.5||||0.016|TWO_SIDED|95.0|-109.0|-6.0|||Wilcoxon (Mann-Whitney)|||Statistical Analysis for the median change of caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT in the HVPG \< 12 mmHg subgroup population treated with IDN-6556 25 mg twice daily||-6|-109|0.016
71121736|NCT02230683|141749227|SUPERIORITY_OR_OTHER||Hodges-Lehmann|12.0||||0.839|TWO_SIDED|95.0|-60.0|13.0|||Wilcoxon (Mann-Whitney)|||Statistical Analysis for the median change of caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT in the HVPG ≥ 12 mmHg subgroup population treated with IDN-6556 25 mg twice daily||13|-60|0.839
71121737|NCT02230683|141749228|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-4.0||||0.0084|TWO_SIDED|95.0|-7.0|0.0|||Wilcoxon (Mann-Whitney)|||Statistical Analysis for the median change in Alanine Aminotransferase (ALT) from Baseline to Day 28/EOT||0|-7|0.0084
71121738|NCT02230683|141749229|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-4.0||||0.0131|TWO_SIDED|95.0|-7.0|-1.0|||Wilcoxon (Mann-Whitney)|||Statistical Analysis for the median change in Aspartate Aminotransferase (AST) from Baseline to Day 28/EOT||-1|-7|0.0131
71121739|NCT02230683|141749230|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-772.0||||0.003|TWO_SIDED|95.0|-1188.0|-19.0|||Wilcoxon (Mann-Whitney)||The estimated value is the ratio for the difference from baseline.|Statistical Analysis for the median change in concentration of Caspase 3/7 Relative Light Units from baseline to Day 28/EOT||-19|-1188|0.003
71121740|NCT00260065|141749231|SUPERIORITY_OR_OTHER||Percentage of Participants|33.0||||||95.0|24.2|43.5||||||||43.5|24.2|
71121741|NCT00260065|141749232|SUPERIORITY_OR_OTHER||Percentage of Participants|52.0||||||95.0|41.3|61.7||||||||61.7|41.3|
71121742|NCT03554772|141749316|SUPERIORITY||||||<|0.0001||||||p-value for each dose group vs placebo comparison|ANCOVA|ANCOVA model included treatment as main effect , baseline NPRS and basline BMI as covariates P-value is Dunnett adjusted (individual treatment arms)||||||<0.0001
71121743|NCT00241631|141749372|SUPERIORITY|||||||0.012|||||||Mixed Models Analysis|||||||0.012
71121744|NCT00241631|141749373|SUPERIORITY||||||<|0.05||||||calculated|Mixed Models Analysis|||||||<0.05
71121745|NCT00241631|141749374|SUPERIORITY||||||<|0.05||||||calculated|Mixed Models Analysis|||||||<0.05
71121746|NCT03883113|141749375|OTHER|||||||0.1711|||||||Wilcoxon (Mann-Whitney)|||||||0.1711
71121747|NCT03883113|141749375|OTHER|||||||0.1654|||||||Wilcoxon (Mann-Whitney)|||||||0.1654
71121748|NCT03883113|141749375|OTHER|||||||0.1711|||||||Wilcoxon (Mann-Whitney)|||||||0.1711
71083204|NCT03365934|141672704|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.043||0.183|TWO_SIDED|95.0|-0.1437|0.0278|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 1||0.0278|-0.1437|0.183
71083205|NCT03365934|141672704|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.044||0.736|TWO_SIDED|95.0|-0.0725|0.1023|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 1||0.1023|-0.0725|0.736
71083206|NCT03365934|141672705|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.052||0.516|TWO_SIDED|95.0|-0.136|0.0687|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 2||0.0687|-0.1360|0.516
71083207|NCT03365934|141672705|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.052||0.006|TWO_SIDED|95.0|-0.2459|-0.0412|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 2||-0.0412|-0.2459|0.006
71083208|NCT03365934|141672705|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.051||0.671|TWO_SIDED|95.0|-0.1235|0.0798|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 2||0.0798|-0.1235|0.671
71083209|NCT03365934|141672705|SUPERIORITY||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.052||0.004|TWO_SIDED|95.0|0.0504|0.2578|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 2||0.2578|0.0504|0.004
71083210|NCT03365934|141672706|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.062||0.292|TWO_SIDED|95.0|-0.1896|0.0579|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 3||0.0579|-0.1896|0.292
71083211|NCT03365934|141672706|SUPERIORITY||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.062||0.016|TWO_SIDED|95.0|-0.2773|-0.0297|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 3||-0.0297|-0.2773|0.016
71083212|NCT03365934|141672706|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.062||0.538|TWO_SIDED|95.0|-0.1622|0.0853|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 3||0.0853|-0.1622|0.538
71083213|NCT03365934|141672706|SUPERIORITY||Mean Difference (Net)|0.012|STANDARD_ERROR_OF_MEAN|0.065||0.061|TWO_SIDED|95.0|-0.0059|0.2515|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 3||0.2515|-0.0059|0.061
70944387|NCT00510146|141388848|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in direct bilirubin from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
70944388|NCT00510146|141388848|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in total bilirubin from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
71083214|NCT03365934|141672707|SUPERIORITY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.06||0.001|TWO_SIDED|95.0|-0.3265|-0.0895|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 4||-0.0895|-0.3265|0.001
71083215|NCT03365934|141672707|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.3614|-0.1243|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 4||-0.1243|-0.3614|<0.001
71083216|NCT03365934|141672707|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.06||0.236|TWO_SIDED|95.0|-0.1899|0.0471|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 4||0.0471|-0.1899|0.236
71083217|NCT03365934|141672707|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.061||0.627|TWO_SIDED|95.0|-0.0902|0.1492|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 4||0.1492|-0.0902|0.627
71083218|NCT03365934|141672708|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.051|<|0.001|TWO_SIDED|95.0|-0.3331|-0.1305|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 5||-0.1305|-0.3331|<0.001
71083219|NCT03365934|141672708|SUPERIORITY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.3091|-0.1092|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 5||-0.1092|-0.3091|<0.001
70855843|NCT04575597|141198543|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.32|||||TWO_SIDED|95.0|0.83|2.09||||||||2.09|0.83|
71083220|NCT03365934|141672708|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.05||0.005|TWO_SIDED|95.0|-0.2439|-0.0457|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 5||-0.0457|-0.2439|0.005
71083221|NCT03365934|141672708|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.052||0.02|TWO_SIDED|95.0|0.0197|0.2252|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 5||0.2252|0.0197|0.020
71083222|NCT03365934|141672709|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.4019|-0.2044|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 6||-0.2044|-0.4019|<0.001
71083223|NCT03365934|141672709|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.3655|-0.1679|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 6||-0.1679|-0.3655|<0.001
71083224|NCT03365934|141672709|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.3338|-0.1377|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 6||-0.1377|-0.3338|<0.001
71083225|NCT03365934|141672709|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.646|TWO_SIDED|95.0|-0.0767|0.1231|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 6||0.1231|-0.0767|0.646
70855844|NCT04575597|141198543|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.47|1.23||||||||1.23|0.47|
70855845|NCT04575597|141198543|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.88|1.16||||||||1.16|0.88|
71083226|NCT03365934|141672710|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.047||0.006|TWO_SIDED|95.0|-0.2254|-0.0384|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 7||-0.0384|-0.2254|0.006
70944389|NCT00510146|141388848|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in uric acid from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
70944390|NCT00510146|141388849|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in erythrocyte count from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||0.003
70944391|NCT00510146|141388850|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in hematocrit from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||0.001
70944392|NCT00510146|141388851|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in hemoglobin A1c from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||0.009
70944393|NCT00510146|141388852|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in hemoglobin from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
70944394|NCT00510146|141388853|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in prolactin from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
70944395|NCT00510146|141388854|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in urinalysis-specific gravity from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
71083227|NCT03365934|141672710|SUPERIORITY||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.047||0.002|TWO_SIDED|95.0|-0.2444|-0.0574|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 7||-0.0574|-0.2444|0.002
70944396|NCT00510146|141388855|SUPERIORITY_OR_OTHER|||||||0.104||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in QTcF interval from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.104
71083228|NCT03365934|141672710|SUPERIORITY||Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.047||0.001|TWO_SIDED|95.0|-0.2541|-0.0682|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 7||-0.0682|-0.2541|0.001
71083229|NCT03365934|141672710|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.048||0.911|TWO_SIDED|95.0|-0.0891|0.0998|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 7||0.0998|-0.0891|0.911
71083230|NCT03365934|141672711|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.04||0.937|TWO_SIDED|95.0|-0.0818|0.0755|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 14||0.0755|-0.0818|0.937
71121749|NCT03883113|141749376|OTHER|||||||1|||||||Fisher Exact|||The statistical analysis applies to participants with Virologically confirmed Influenza-like Illness versus participants without Virologically confirmed Influenza-like Illness||||1.000
70944397|NCT00510146|141388855|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in QTcB interval from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.006
70944398|NCT00510146|141388856|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in heart rate from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.035
70944399|NCT00510146|141388857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.943|TWO_SIDED|95.0|-0.59|0.64||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint for MINI Suicidality Total Score from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||0.64|-0.59|0.943
71121750|NCT03883113|141749377|OTHER|||||||0.143|||||||Fisher Exact|||This statistical analysis applies to participants with qPCR confirmed Influenza versus participants with no qPCR confirmed Influenza||||0.143
70855846|NCT04575597|141198544|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.62|1.41||||||||1.41|0.62|
70944400|NCT00510146|141388865|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||p-value represents change from baseline to endpoint-standing diastolic blood pressure from t-tests on change.|t-test, 2 sided|||||||0.736
70944401|NCT00510146|141388865|SUPERIORITY_OR_OTHER|||||||0.944||95.0||||p-value represents change from baseline to endpoint-sitting diastolic blood pressure from t-tests on change.|t-test, 2 sided|||||||0.944
70944402|NCT00510146|141388865|SUPERIORITY_OR_OTHER|||||||0.08||95.0||||p-value represents change from baseline to endpoint-standing systolic blood pressure from t-tests on change.|t-test, 2 sided|||||||0.080
70944403|NCT00510146|141388865|SUPERIORITY_OR_OTHER|||||||0.612||95.0||||p-value represents change from baseline to endpoint-sitting systolic blood pressure from t-tests on change.|t-test, 2 sided|||||||0.612
70944404|NCT00510146|141388865|SUPERIORITY_OR_OTHER|||||||0.64||95.0||||p-value represents change from baseline to endpoint-orthostatic change in diastolic blood pressure from t-tests on change.|t-test, 2 sided|||||||0.640
70944405|NCT00510146|141388865|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||p-value represents change from baseline to endpoint-orthostatic change in systolic blood pressure from t-tests on change.|t-test, 2 sided|||||||0.122
70944406|NCT00510146|141388866|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents change from baseline to endpoint for weight from t-tests on change.|t-test, 2 sided|||||||<0.001
70944407|NCT00510146|141388867|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents change from baseline to endpoint for albumin from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||<0.001
70944408|NCT00510146|141388867|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value represents change from baseline to endpoint for total protein from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.002
70944409|NCT00510146|141388868|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value represents change from baseline to endpoint for alkaline phosphatase from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.002
70944410|NCT00510146|141388868|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||p-value represents change from baseline to endpoint for CPK from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.010
70855847|NCT04575597|141198544|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.7|1.69||||||||1.69|0.70|
70855848|NCT04575597|141198544|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.66|1.51||||||||1.51|0.66|
70855849|NCT04575597|141198544|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|1.01|1.31||||||||1.31|1.01|
70855850|NCT04575597|141198545|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.54|1.69||||||||1.69|0.54|
71083231|NCT03365934|141672711|SUPERIORITY||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.039||0.026|TWO_SIDED|95.0|-0.1663|-0.0108|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 14||-0.0108|-0.1663|0.026
71083232|NCT03365934|141672711|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.039||0.045|TWO_SIDED|95.0|-0.1562|-0.0017|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 14||-0.0017|-0.1562|0.045
71083233|NCT03365934|141672711|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.039||0.956|TWO_SIDED|95.0|-0.0799|0.0755|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 14||0.0755|-0.0799|0.956
71083234|NCT01781208|141672712|SUPERIORITY_OR_OTHER||||||<|0.0001||||||r=0.68, unadjusted for age, gender, and histologic inflammation.|Pearson Correlation|||Continuous data were summarized using means and standard deviations. The relationship between ARFI (VTQ) liver shear wave speed and liver histologic fibrosis score were assessed using Pearson correlation. No a priori power analysis was performed.||||<0.0001
71083235|NCT01781208|141672712|SUPERIORITY_OR_OTHER||||||<|0.0001||||||r=0.73, unadjusted for age, gender, and histologic inflammation score|Pearson Correlation|||Continuous data were summarized using means and standard deviations. The relationship between ARFI (VTIQ) liver shear wave speed and liver histologic fibrosis score were assessed using Pearson correlation. No a priori power analysis was performed.||||<0.0001
71083236|NCT04194489|141672720|OTHER|Effect size calculation|Cohen's d|0.43|||||TWO_SIDED|||||||||Cohen's d effect size was calculated using baseline and follow-up means and standard deviations. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.||||
71083237|NCT04194489|141672721|OTHER|Effect size|Cohen's d|0.17|||||TWO_SIDED|||||||||Cohen's d effect size was calculated using baseline and follow-up means and standard deviations. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.||||
71083238|NCT04194489|141672722|OTHER|Effect size calculation|Cohen's d|0.27|||||TWO_SIDED|||||||||Cohen's d effect size was calculated using baseline and follow-up means and standard deviations. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.||||
71083239|NCT04194489|141672723|OTHER|Effect size calculation|Cohen's d|0.02|||||TWO_SIDED|||||||||Cohen's d effect size was calculated using baseline and follow-up means and standard deviations. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.||||
71083240|NCT03397121|141672746|SUPERIORITY||Mean Difference (Final Values)|-49.52|||<|0.0001|TWO_SIDED|95.0|-55.04|-43.99||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-43.99|-55.04|<.0001
71083241|NCT03397121|141672747|SUPERIORITY||Mean Difference (Final Values)|-44.3|||<|0.0001|TWO_SIDED|95.0|-48.48|-40.12||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-40.12|-48.48|<0.0001
71083242|NCT03397121|141672748|SUPERIORITY||Mean Difference (Final Values)|-68.89|||<|0.0001|TWO_SIDED|95.0|-77.11|-60.67||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-60.67|-77.11|<0.0001
71083243|NCT03397121|141672749|SUPERIORITY||Mean Difference (Final Values)|-62.74|||<|0.0001|TWO_SIDED|95.0|-69.01|-56.48||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-56.48|-69.01|<0.0001
71083244|NCT03397121|141672750|SUPERIORITY||Mean Difference (Final Values)|-78.34|||<|0.0001|TWO_SIDED|95.0|-83.65|-73.04||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-73.04|-83.65|<0.0001
71083245|NCT03397121|141672751|SUPERIORITY|LS Mean Difference (95% CI) from Placebo|Mean Difference (Final Values)|-31.77|||<|0.0001|TWO_SIDED|95.0|-35.59|-27.94||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-27.94|-35.59|<0.0001
71083246|NCT03397121|141672752|SUPERIORITY||Mean Difference (Final Values)|-36.06|||<|0.0001|TWO_SIDED|95.0|-39.99|-32.14||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-32.14|-39.99|<0.0001
71083247|NCT03397121|141672753|SUPERIORITY||Mean Difference (Final Values)|-42.36|||<|0.0001|TWO_SIDED|95.0|-47.32|-37.4||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-37.40|-47.32|<0.0001
71083248|NCT04085601|141672756|SUPERIORITY||Difference|0.7311|||<|0.0001|TWO_SIDED|95.0|0.572|0.8902||Cochran-Mantel-Haenszel test is stratified by number of packed red blood cell (PRBC) within 12 months prior to screening (\<4, ≥ 4) reported in electronic data capture (EDC) data.|Cochran-Mantel-Haenszel|||||0.8902|0.572|<0.0001
71083249|NCT04085601|141672757|SUPERIORITY||LS mean difference|-1470.38|||<|0.0001|TWO_SIDED|95.0|-2113.44|-827.32||p-value for Baseline, strata and treatment is from LS mean of proc mixed and proc mianalyze based on parameter estimates.|ANCOVA|||||-827.32|-2113.44|<0.0001
71083250|NCT04085601|141672758|SUPERIORITY||Difference|0.5411|||<|0.0001|TWO_SIDED|95.0|0.339|0.7431||Cochran-Mantel-Haenszel test is stratified by number of PRBC within 12 months prior to screening (\<4, ≥ 4) reported in EDC data.|Cochran-Mantel-Haenszel|||||0.7431|0.339|<0.0001
71083251|NCT04085601|141672759|SUPERIORITY||LS mean difference|-103.82||||0.0002|TWO_SIDED|95.0|-158.9|-48.74||P-value for Baseline, strata and treatment is from LS mean of proc mixed and proc mianalyze based on parameter estimates.|ANCOVA|||||-48.74|-158.9|0.0002
70855851|NCT04575597|141198545|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.61|2.0||||||||2.00|0.61|
70855852|NCT04575597|141198545|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.5|1.38||||||||1.38|0.50|
70855853|NCT04575597|141198545|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.9|1.21||||||||1.21|0.90|
71121751|NCT03883113|141749378|OTHER|||||||0.3504|||||||Fisher Exact|||This statistical analysis applies to participants with qCulture confirmed Influenza versus participants without qCulture confirmed Influenza||||0.3504
71121752|NCT03883113|141749379|OTHER|||||||0.5558|||||||Log Rank|||||||0.5558
71121753|NCT03883113|141749380|OTHER|||||||0.6534|||||||Log Rank|||||||0.6534
71121754|NCT03883113|141749381|OTHER|||||||0.5485|||||||Wilcoxon (Mann-Whitney)|||||||0.5485
71121755|NCT03883113|141749382|OTHER|||||||0.6753|||||||Wilcoxon (Mann-Whitney)|||||||0.6753
71121756|NCT03883113|141749383|OTHER|||||||0.711|||||||Log Rank|||||||0.711
71121757|NCT03883113|141749384|OTHER|||||||0.4689|||||||Log Rank|||||||0.4689
71121758|NCT03883113|141749387|OTHER|||||||0.5001|||||||Wilcoxon (Mann-Whitney)|||||||0.5001
71121759|NCT03883113|141749388|OTHER|||||||0.6799|||||||zero-inflated poisson model|||||||0.6799
71121760|NCT03883113|141749389|OTHER|||||||0.5911|||||||Wilcoxon (Mann-Whitney)|||||||0.5911
71121761|NCT03523273|141749409|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
71121762|NCT03523273|141749410|SUPERIORITY|||||||0.033|||||||Wilcoxon (Mann-Whitney)|||||||0.033
70855854|NCT04575597|141198546|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.46|||||TWO_SIDED|95.0|0.77|2.76||||||||2.76|0.77|
71121763|NCT01457950|141749417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.21|||<|0.0001|TWO_SIDED|95.0|2.06|4.36|||ANCOVA|||||4.36|2.06|<0.0001
71121764|NCT00435162|141749454|SUPERIORITY_OR_OTHER||Slope|-1.05||||0.099|TWO_SIDED|95.0|-2.31|0.2|||Regression, Linear|||Slope change across all 3 active treatment groups.||0.20|-2.31|0.0990
71121765|NCT02963987|141749458|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71121766|NCT02963987|141749459|SUPERIORITY|||||||0.006|||||||Mixed Models Analysis|||||||0.006
71121767|NCT02963987|141749460|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71121768|NCT02266277|141749478|SUPERIORITY|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio (OR)|1.3||||0.0001|TWO_SIDED|95.0|1.15|1.47||Adjusted for age, sex, race and utilization|Regression, Logistic|||||1.47|1.15|0.0001
71121769|NCT02266277|141749478|SUPERIORITY|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio (OR)|1.2||||0.0026|TWO_SIDED|95.0|1.07|1.36|||Regression, Logistic|||||1.36|1.07|.0026
71121770|NCT02266277|141749478|SUPERIORITY|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio (OR)|1.16||||0.0206|TWO_SIDED|95.0|1.02|1.31|||Regression, Logistic|||||1.31|1.02|.0206
71121771|NCT02266277|141749478|SUPERIORITY|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio (OR)|1.07||||0.233|TWO_SIDED|95.0|0.96|1.21|||Regression, Logistic|||||1.21|.96|.2330
71121772|NCT02266277|141749478|SUPERIORITY|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio, log|1.12||||0.0579|TWO_SIDED|95.0|0.996|1.26|||Regression, Logistic|||||1.26|.996|.0579
71121773|NCT02266277|141749478|SUPERIORITY|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio (OR)|0.99||||0.87|TWO_SIDED|95.0|0.86|1.14|||Regression, Logistic|||||1.14|.86|.87
71121774|NCT02266277|141749479|SUPERIORITY|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio (OR)|1.03||||0.82|TWO_SIDED|95.0|0.81|1.31|||Regression, Logistic|||||1.31|.81|.82
71121775|NCT02266277|141749479|SUPERIORITY|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio, log|0.9||||0.36|TWO_SIDED|95.0|0.71|1.13|||Regression, Logistic|||||1.13|.71|.36
71083252|NCT04085601|141672760|SUPERIORITY||LS mean difference|2.67||||0.0019|TWO_SIDED|95.0|0.99|4.35||P-value for baseline, strata and treatment is from LS mean of proc mixed and proc mianalyze based on parameter estimates.|ANCOVA|||||4.35|0.99|0.0019
71083253|NCT04085601|141672761|SUPERIORITY||Difference|-0.7505|||<|0.0001|TWO_SIDED|95.0|-0.9041|-0.5969||Cochran-Mantel-Haenszel test is stratified by number of PRBC within 12 months prior to screening (\<4, ≥4) reported in EDC data.|Cochran-Mantel-Haenszel|||||-0.5969|-0.9041|<0.0001
71083254|NCT04085601|141672762|SUPERIORITY||Difference|0.7241|||<|0.0001|TWO_SIDED|95.0|0.5583|0.8899||Cochran-Mantel-Haenszel test is stratified by number of PRBC within 12 months prior to screening (\<4, ≥4) reported in EDC data.|Cochran-Mantel-Haenszel|||||0.8899|0.5583|<0.0001
71083255|NCT04085601|141672763|SUPERIORITY||Median Difference (Net)|3.0|||<|0.0001|TWO_SIDED|95.0|2.0|4.0||Wilcoxon rank-sum test p-value for the comparison between treatments is based on median using stratified non-parametric analysis. The 95% confidence interval (CI) is constructed using Hodges-Lehmann Estimation of Location Shift.|Wilcoxon Rank-Sum Test|||||4|2|<0.0001
71083256|NCT04085601|141672764|SUPERIORITY||LS mean difference|4.51||||0.061|TWO_SIDED|95.0|-0.21|9.24||P-value for baseline, strata and treatment is from LS mean of proc mixed and proc mianalyze based on parameter estimates.|ANCOVA|||||9.24|-0.21|0.061
70855855|NCT04575597|141198546|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.76|||||TWO_SIDED|95.0|0.92|3.38||||||||3.38|0.92|
70855856|NCT04575597|141198546|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.52|||||TWO_SIDED|95.0|0.81|2.86||||||||2.86|0.81|
70855857|NCT04575597|141198546|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.89|1.24||||||||1.24|0.89|
70855858|NCT04575597|141198547|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.33|||||TWO_SIDED|95.0|0.81|2.2||||||||2.20|0.81|
70855859|NCT04575597|141198547|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.4|||||TWO_SIDED|95.0|0.85|2.31||||||||2.31|0.85|
70855860|NCT04575597|141198547|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.57|1.65||||||||1.65|0.57|
70855861|NCT04575597|141198547|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.89|1.18||||||||1.18|0.89|
70855862|NCT04575597|141198548|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.36|1.91||||||||1.91|0.36|
70855863|NCT04575597|141198548|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.37|||||TWO_SIDED|95.0|0.64|2.97||||||||2.97|0.64|
70855864|NCT04575597|141198548|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.37|2.02||||||||2.02|0.37|
70855865|NCT04575597|141198548|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.74|1.14||||||||1.14|0.74|
70855866|NCT04575597|141198549|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.44|1.06||||||||1.06|0.44|
70855867|NCT04575597|141198550|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.21|||||TWO_SIDED|95.0|0.06|0.67||||||||0.67|0.06|
70855868|NCT04575597|141198550|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.33|||||TWO_SIDED|95.0|0.13|0.83||||||||0.83|0.13|
70855869|NCT04575597|141198550|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.27|||||TWO_SIDED|95.0|0.09|0.79||||||||0.79|0.09|
70855870|NCT04575597|141198550|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.87|1.36||||||||1.36|0.87|
70855871|NCT04575597|141198551|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.29|||||TWO_SIDED|95.0|0.74|2.23||||||||2.23|0.74|
70855872|NCT04575597|141198551|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.45|1.8||||||||1.80|0.45|
71083257|NCT04085601|141672765|SUPERIORITY||Difference|0.3645||||0.001|TWO_SIDED|95.0|0.1648|0.5642|||Cochran-Mantel-Haenszel|||||0.5642|0.1648|0.001
71083258|NCT04085601|141672766|SUPERIORITY||Difference|0.5592|||<|0.0001|TWO_SIDED|95.0|0.3682|0.7502|||Cochran-Mantel-Haenszel|||||0.7502|0.3682|<0.0001
70944411|NCT00510146|141388868|SUPERIORITY_OR_OTHER|||||||0.354||95.0||||p-value represents change from baseline to endpoint for GGT from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.354
70944412|NCT00510146|141388869|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||p-value represents change from baseline to endpoint for chlorine from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.010
71121776|NCT02266277|141749479|SUPERIORITY|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio (OR)|0.89||||0.33|TWO_SIDED|95.0|0.71|1.13|||Regression, Logistic|||||1.13|.71|.33
71121777|NCT02266277|141749479|SUPERIORITY|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio (OR)|0.87||||0.23|TWO_SIDED|95.0|0.69|1.09|||Regression, Logistic|||||1.09|.69|.23
71121778|NCT02266277|141749479|SUPERIORITY|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio (OR)|0.99||||0.96|TWO_SIDED|95.0|0.79|1.25|||Regression, Logistic|||||1.25|.79|.96
71121779|NCT02266277|141749479|SUPERIORITY|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio (OR)|1.04||||0.76|TWO_SIDED|95.0|0.82|1.31|||Regression, Logistic|||||1.31|.82|.76
71121780|NCT03249935|141749522|SUPERIORITY|||||||||||||||||Assumptions were that 20% of enrolled chlamydia-infected males will have urethral symptoms and azithromycin treatment failures will occur in 10% of symptomatic men vs. 2% of asymptomatic men. At a one-sided 0.05 significance level with power of 0.80, a sample size of 357 evaluable males would be needed, or approximately 72 symptomatic and 285 asymptomatic males. Assuming 20% of males enrolled would be unevaluable, a total of 446 males was targeted for enrollment.|Given that the study closed early and there were only 4 treatment failures, formal hypothesis testing was not performed.|||
71121781|NCT03249935|141749523|SUPERIORITY||Odds Ratio (OR)|0.75||||0.656|TWO_SIDED|95.0|0.22|2.62|||Regression, Logistic|||Unadjusted odds ratio for age in years as a continuous variable in a logistic regression model predicting treatment failure at day 28||2.62|0.22|0.656
71121782|NCT03249935|141749523|SUPERIORITY||Odds Ratio (OR)|4.65||||0.197|TWO_SIDED|95.0|0.45|47.89|||Regression, Logistic|||Unadjusted odds ratio for reporting at baseline new partners in the last 30 days (reference group=no new partners) from a logistic model predicting treatment failure at day 28.||47.89|0.45|0.197
71121783|NCT03249935|141749523|SUPERIORITY||Odds Ratio (OR)|0.68||||0.058|TWO_SIDED|95.0|0.45|1.01|||Regression, Logistic|||Unadjusted odds ratio for Chlamydia viral load at baseline as a continuous variable in a logistic model predicting treatment failure at day 28.||1.01|0.45|0.058
71121784|NCT01669421|141749536|OTHER|Data was analyzed with multiple repeat ANOVA for all visits and paired samples were also evaluated.|||||<|0.05|||||||Kruskal-Wallis|||IL-2||||<0.05
70944413|NCT00510146|141388870|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents change from baseline to endpoint for creatinine from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||<0.001
71121785|NCT01669421|141749536|OTHER|Kruskal-Wallis||||||0.035|||||||Kruskal-Wallis|||IL-4||||0.035
71121786|NCT01669421|141749536|OTHER|||||||0.33|||||||Kruskal-Wallis|||IL-8||||0.33
71121787|NCT01669421|141749536|OTHER|||||||0.68|||||||Kruskal-Wallis|||IL-9||||0.68
71121788|NCT01669421|141749536|OTHER|||||||0.02|||||||Kruskal-Wallis|||IL-17||||0.020
71121789|NCT01669421|141749536|OTHER|||||||0.021|||||||Kruskal-Wallis|||FGF||||0.021
71121790|NCT01669421|141749536|OTHER|||||||0.02|||||||Kruskal-Wallis|||Eotaxin||||0.02
71121791|NCT01669421|141749536|OTHER|||||||0.045|||||||Kruskal-Wallis|||GM-CSF||||0.045
71121792|NCT01669421|141749536|OTHER|||||||0.47|||||||Kruskal-Wallis|||IL15||||0.47
71121793|NCT01669421|141749536|OTHER|||||||0.9|||||||Kruskal-Wallis|||IL-1a||||0.90
71121794|NCT01669421|141749536|OTHER|||||||0.8|||||||Kruskal-Wallis|||IL18||||0.80
70944414|NCT00510146|141388871|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||p-value represents change from baseline to endpoint for erythrocyte count from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.021
70944415|NCT00510146|141388872|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||p-value represents change from baseline to endpoint for hemoglobin from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.035
70944416|NCT00510146|141388873|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||p-value represents change from baseline to endpoint for platelet count from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.024
71121795|NCT01669421|141749536|OTHER|||||||0.027|||||||Kruskal-Wallis|||M-CSF||||0.027
71121796|NCT01669421|141749537|OTHER|||||||0.07|||||||Kruskal-Wallis|||No power calculation and this is an exploratory pilot analysis We expected cytokines to decrease after subjects receive double dose and a rebound after administering standard dose.||||0.07
71121797|NCT01669421|141749539|OTHER|between Week 4 and Week 8||||||0.03|||||||t-test, 2 sided|||Desmosine (DES) and isodesmosine (IDES) are used as indicator of elastin degradation. Levels of DES/IDES were measured using high-performance liquid chromatography and tandem mass spectrometry.||||0.03
71121798|NCT01669421|141749539|OTHER|||||||0.33|||||||t-test, 2 sided|||between Week 8 and Week 12||||0.33
71121799|NCT01669421|141749539|OTHER|||||||0.029|||||||Kruskal-Wallis|||between Week 4 and Week 12||||0.029
71121800|NCT01479595|141749610|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.514||||0.005|TWO_SIDED|90.0|-0.811|-0.217|||Mixed Models Analysis|||||-0.217|-0.811|0.005
71121801|NCT05268744|141749621|SUPERIORITY|Since all outcomes were normally distributed, one-sided paired t-test was used to compare mean pre- and post-treatment scores to see whether post-treatment scores of ABI-S and SRS had improved compared to pre-treatment scores|||||<|0.05|||||||t-test, 1 sided|||Null hypothesis was no improvement in mean ABI-S and SRS scores at the end of the study, compared to baseline||||<0.05
70855873|NCT04575597|141198551|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.55|1.89||||||||1.89|0.55|
70855874|NCT04575597|141198551|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.94|1.37||||||||1.37|0.94|
70855875|NCT04575597|141198552|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.39|||||TWO_SIDED|95.0|0.83|2.33||||||||2.33|0.83|
70855876|NCT04575597|141198552|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.5|1.48||||||||1.48|0.50|
70855877|NCT04575597|141198552|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.56|1.72||||||||1.72|0.56|
71121802|NCT03906656|141749637|SUPERIORITY||Mean Difference (Final Values)|3.5|STANDARD_DEVIATION|8.1||0.0002|TWO_SIDED|||||Adjusted p-values based on Holm-Bonferroni method. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided||Mean difference is for paired data (n=73). This explains the discrepancy between the mean difference and the difference between the KAFO and C-Brace means (n=86 and n=77, respectively).|H0: the mean difference (C-Brace - KAFO) \<= 0.||||0.0002
71121803|NCT03906656|141749637|SUPERIORITY||Mean Difference (Final Values)|6.8|STANDARD_DEVIATION|9.7|<|1e-05|TWO_SIDED|||||Adjusted p-values based on Holm-Bonferroni method. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided||Mean difference is for paired data (n=77). This explains the discrepancy between the mean difference and the difference between the KAFO and C-Brace means (n=86 and n=77, respectively).|H0: the mean difference (C-Brace - Baseline) \<= 0.||||<0.00001
71121804|NCT03906656|141749637|SUPERIORITY||Mean Difference (Final Values)|3.3|STANDARD_DEVIATION|6.3|<|1e-05|TWO_SIDED||||||t-test, 2 sided||Mean difference is for paired data (n=86). This explains the discrepancy between the mean difference and the difference between the Baseline and KAFO means (n=102 and n=86, respectively).|KAFO vs. Baseline -- H0: the mean difference (KAFO - Baseline) \<= 0.||||<0.00001
71121805|NCT03906656|141749638|SUPERIORITY||Mean Difference (Final Values)|7.05|STANDARD_DEVIATION|26.3||0.005|TWO_SIDED|||||P-value not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|63.6 degrees of freedom.||H0: the mean difference (C-Brace - KAFO) \<= 0||||0.005
71121806|NCT03906656|141749639|SUPERIORITY|P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|3.7||0.005|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|74.4 degrees of freedom||H0: the mean difference (C-Brace - KAFO) \<= 0.||||0.005
71121807|NCT03906656|141749640|SUPERIORITY||Mean Difference (Final Values)|0.185|STANDARD_DEVIATION|53.6||0.583|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test|||H0: the median of the population differences (C-Brace - KAFO) \<= 0.|Wilcoxon Signed Rank Test. V=1207.5, effect size r = 0.026, p=0.583.|||0.583
71121808|NCT03906656|141749641|SUPERIORITY||Mean Difference (Final Values)|1.28|STANDARD_DEVIATION|4.37||0.0078|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test|||H0: the median of the population differences (C-Brace - KAFO) \<= 0. (SAI - Down)|Wilcoxon Signed Rank Test V=438, effect size r = 0.21, p=0.008|||0.0078
71121809|NCT03906656|141749642|SUPERIORITY||Mean Difference (Final Values)|-3.41|STANDARD_DEVIATION|17.0||0.002|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test||||Wilcoxon Signed Rank Test V=267, effect size r = 0.32, p=0.002|||0.0020
71121810|NCT03906656|141749643|SUPERIORITY||Mean Difference (Final Values)|-1.11|STANDARD_DEVIATION|3.178||0.0023|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test|||H0: the median of the population differences (C-Brace - KAFO) \<= 0. (Fear of falling - indoors)|Wilcoxon Signed Rank Test V=433, effect size r = 0.33, p=0.002|||0.0023
71121811|NCT03906656|141749643|SUPERIORITY||Mean Difference (Final Values)|-0.973|STANDARD_DEVIATION|3.43||0.0066|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test||||Wilcoxon Signed Rank Test V=557.5, effect size r = 0.265, p=0.0066|||0.0066
71121812|NCT03906656|141749644|SUPERIORITY|||||||0.006||||||P-value not adjusted for multiple comparisons|McNemar|||Paired dataset. H0: The probability of fallers wearing C-Brace becoming non-fallers wearing KAFO is the same as the probability of non-fallers wearing C-Brace becoming fallers wearing KAFO.||||0.006
71121813|NCT03906656|141749645|SUPERIORITY||Mean Difference (Final Values)|2.82|STANDARD_DEVIATION|16.4||0.08|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test|||H0: the median of the population differences (C-Brace - KAFO) \<= 0.|Wilcoxon Signed Rank Test. V=1325.5, effect size r = 0.181, p=0.08.|||0.08
70855878|NCT04575597|141198552|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|1.01|1.43||||||||1.43|1.01|
70855879|NCT04575597|141198553|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.29|2.19||||||||2.19|0.29|
70855880|NCT04575597|141198553|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.34|2.44||||||||2.44|0.34|
70855881|NCT04575597|141198553|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.77|||||TWO_SIDED|95.0|0.74|4.23||||||||4.23|0.74|
70855882|NCT04575597|141198553|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.67|1.04||||||||1.04|0.67|
70855883|NCT04575597|141198554|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|2.52|||||TWO_SIDED|95.0|0.98|6.53||||||||6.53|0.98|
70855884|NCT04575597|141198554|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.23|2.52||||||||2.52|0.23|
70855885|NCT04575597|141198554|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.11|1.84||||||||1.84|0.11|
70855886|NCT04575597|141198554|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.66|1.16||||||||1.16|0.66|
70855887|NCT04575597|141198555|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.23|||||TWO_SIDED|95.0|0.46|3.32||||||||3.32|0.46|
70855888|NCT04575597|141198555|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.42|||||TWO_SIDED|95.0|0.54|3.74||||||||3.74|0.54|
70855889|NCT04575597|141198555|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.34|2.76||||||||2.76|0.34|
70855890|NCT04575597|141198555|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.66|1.1||||||||1.10|0.66|
70855891|NCT04575597|141198556|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.41|2.52||||||||2.52|0.41|
70944417|NCT00510146|141388874|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents change from baseline to endpoint for prolactin from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||<0.001
71121814|NCT03906656|141749646|SUPERIORITY||Mean Difference (Final Values)|0.009|STANDARD_DEVIATION|0.184||0.151|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test||Wilcoxon Signed Rank Test V=1124.5, effect size r = 0.125 p=0.151|H0: the median of the population differences (C-Brace - KAFO) \<= 0||||0.151
71121815|NCT03906656|141749647|SUPERIORITY|H0: the mean of the population differences (C-Brace - KAFO) \>= 0|Mean Difference (Final Values)|-2.1|STANDARD_DEVIATION|21.5||0.281|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|16.7 degrees of freedom||WLQ-25 - Physical||||0.281
71121816|NCT03906656|141749648|SUPERIORITY||Mean Difference (Final Values)|1.99|STANDARD_DEVIATION|5.18||0.00019|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|48.4 degrees of freedom||OPUS - Low Extremity Functional Status. H0: the mean difference (C-Brace - KAFO) \<= 0||||0.00019
71121817|NCT03906656|141749649|SUPERIORITY||Mean Difference (Final Values)|3.19|STANDARD_DEVIATION|15.0||0.0226|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|22.1 degrees of freedom||Emotional well-being. H0: the mean difference (C-Brace - KAFO) \<= 0.||||0.0226
71121818|NCT03906656|141749649|SUPERIORITY||Mean Difference (Final Values)|6.79|STANDARD_DEVIATION|21.1||0.002|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|||Energy/Fatigue. H0: the mean difference (C-Brace - KAFO) \<= 0.||||0.0020
71121819|NCT03906656|141749649|SUPERIORITY||Mean Difference (Final Values)|10.1|STANDARD_DEVIATION|29.528||0.0049|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test|||Health change. H0: the median of the population differences (C-Brace - KAFO) \<= 0.|Wilcoxon Signed Rank Test. V=649, effect size r = 0.285, p=0.00493|||0.0049
71121820|NCT03906656|141749649|SUPERIORITY||Mean Difference (Final Values)|12.6|STANDARD_DEVIATION|29.2||6.47e-05|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|37.35 degrees of freedom||Physical Functioning Score. H0: the mean difference (C-Brace - KAFO) \<= 0||||0.0000647
71121821|NCT03906656|141749650|SUPERIORITY||Mean Difference (Final Values)|0.28|STANDARD_DEVIATION|0.843||0.301|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test|||Device. H0: the median of the population differences (C-Brace - KAFO) \<= 0|Wilcoxon Signed Rank Test V=1018.5, effect size r = 0.056, p=0.301|||0.301
71121822|NCT00882908|141749662|SUPERIORITY_OR_OTHER||Difference in proportions of SVRW72|13.0||||0.051|TWO_SIDED|97.5|-1.9|28.0|||Regression, Logistic||Difference in percentages of participants in the TMC435 75mg and placebo groups with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72 estimated from the logistic regression model.|TMC435 75 mg 12 and 24 week treatment groups were pooled and the percentage of participants acheiving SVRW72 were compared with the percentage of participants acheiving SVRW72 in the placebo treatment group.||28.0|-1.9|0.051
71121823|NCT00882908|141749662|SUPERIORITY_OR_OTHER||Difference in proportions of SVRW72|18.9||||0.004|TWO_SIDED|97.5|4.4|33.5|||Regression, Logistic||Difference in percentages of participants in the TMC435 150mg and placebo groups with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72 estimated from the logistic regression model.|TMC/PR 150 mg 12 and 24 week treatment groups were pooled and the percentage of participants achieving SVRW72 was compared the percentage of participants achieving SVRW72 in the placebo treatment group.||33.5|4.4|0.004
71121824|NCT02370095|141749677|SUPERIORITY|||||||0.2416|||||||Wilcoxon (Mann-Whitney)|||Only one placebo subject had data to allow for change from baseline to be calculated||||0.2416
70944418|NCT00510146|141388875|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents change from baseline to endpoint for uric acid from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||<0.001
70855892|NCT04575597|141198556|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.26|1.9||||||||1.90|0.26|
70855893|NCT04575597|141198556|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|0.51|3.0||||||||3.00|0.51|
70855894|NCT04575597|141198556|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.69|1.17||||||||1.17|0.69|
71121825|NCT02370095|141749678|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|The change in S/F ratio over time was evaluated using a mixed model for repeated measures||||||0.06
71121826|NCT02370095|141749679|SUPERIORITY|||||||0.0679|||||||Wilcoxon (Mann-Whitney)|||||||0.0679
71121827|NCT02370095|141749684|SUPERIORITY|||||||0.567|||||||Mixed Models Analysis|Measurement of MAP were evaluated from baseline to end of treatment||||||0.567
71121828|NCT02370095|141749685|SUPERIORITY|||||||0.2507||||||The threshold for statistical significance was 0.05|Fisher Exact|||||||0.2507
71121829|NCT02370095|141749687|SUPERIORITY|||||||0.5055|||||||Fisher Exact|||||||0.5055
70855895|NCT04575597|141198557|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.36|1.75||||||||1.75|0.36|
70855896|NCT04575597|141198557|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.33|1.64||||||||1.64|0.33|
70855897|NCT04575597|141198557|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.31|1.62||||||||1.62|0.31|
70855898|NCT04575597|141198557|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.76|1.16||||||||1.16|0.76|
71121830|NCT02130986|141749698|SUPERIORITY||Mean Difference (Net)|-0.05||||0.87|TWO_SIDED||||||t-test, 2 sided|||||||0.87
71121831|NCT02130986|141749699|NON_INFERIORITY|Procalcitonin algorithm implementation increases or does not change the proportion of subjects who experience a composite endpoint of adverse outcomes by Day 30. The prespecified noninferiority margin is 4.5 percentage.|Risk Difference (RD)|-0.015|||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
70855899|NCT04575597|141198558|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.25|1.39||||||||1.39|0.25|
70944419|NCT00510146|141388876|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||p-value represents change from baseline to endpoint for fasting glucose from t-tests on change.|t-test, 2 sided|||||||0.047
71121832|NCT02130986|141749700|SUPERIORITY||Risk Difference (RD)|-4.6|||||TWO_SIDED|95.0|-12.2|30.0||||||||30|-12.2|
71121833|NCT01498185|141749796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|18.5425|||TWO_SIDED|95.0|-40.85|35.86||No formal statistical testing was performed to compare between treatment groups.|Descriptive statistics|||||35.86|-40.85|
71121834|NCT01498185|141749796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|16.7228|||TWO_SIDED|95.0|-35.36|33.82||No formal statistical testing was performed to compare between treatment groups.|Descriptive statistics|||||33.82|-35.36|
71121835|NCT01498185|141749796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.88|STANDARD_ERROR_OF_MEAN|17.1548|||TWO_SIDED|95.0|-42.21|28.45||No formal statistical testing was performed to compare between treatment groups.|Descriptive statistics|||||28.45|-42.21|
71121836|NCT01498185|141749796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|18.4617|||TWO_SIDED|95.0|-39.22|37.16||No formal statistical testing was performed to compare between treatment groups.|Descriptive statistics|||||37.16|-39.22|
71121837|NCT00946322|141749804|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.028
71121838|NCT00946322|141749805|SUPERIORITY_OR_OTHER|||||||0.022|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-tests were used. Due to variable skewness, variables were logarithm-transformed to improve their distributions.||||.022
71121839|NCT00946322|141749806|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.043
71121840|NCT00946322|141749807|SUPERIORITY_OR_OTHER|||||||0.482|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.482
71121841|NCT00946322|141749808|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.009
71121842|NCT00946322|141749809|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.001
71121843|NCT00946322|141749810|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.027
71121844|NCT00946322|141749811|SUPERIORITY_OR_OTHER|||||||0.177|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.177
71121845|NCT02725593|141749824|SUPERIORITY||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.45||0.101|TWO_SIDED|95.0|-1.65|0.15|||Mixed model repeated measures analysis|||||0.15|-1.65|0.101
71121846|NCT02725593|141749825|SUPERIORITY||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.81||0.34|TWO_SIDED|95.0|-2.42|0.85|||Mixed model repeated measures analysis|||||0.85|-2.42|0.340
71121847|NCT02725593|141749826|SUPERIORITY||Mean Difference (Final Values)|-3.96||||0.655|TWO_SIDED|95.0|-20.11|9.62|||Fisher's exact test|||||9.62|-20.11|0.655
71121848|NCT02725593|141749827|SUPERIORITY||Mean Difference (Final Values)|20.83||||0.056|TWO_SIDED|95.0|0.5|41.11|||Fisher's exact test|||||41.11|0.50|0.056
71121849|NCT04411420|141749842|SUPERIORITY||Mean Difference (Final Values)|-0.59||||0.169|TWO_SIDED|97.5|-1.55|0.37||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway 3-month change minus Coordinated Care Management Pathway 3-month change.|||0.37|-1.55|0.169
71121850|NCT04411420|141749843|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.139|TWO_SIDED|97.5|-0.33|1.52||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway 3-month change minus Coordinated Care Management Pathway 3-month change.|||1.52|-0.33|0.139
71121851|NCT04411420|141749844|SUPERIORITY||Mean Difference (Final Values)|-0.48||||0.417|TWO_SIDED|95.0|-1.69|0.72||P-value is not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.||||0.72|-1.69|0.417
71121852|NCT04411420|141749845|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.409|TWO_SIDED|95.0|-1.37|0.57||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.57|-1.37|0.409
71121853|NCT04411420|141749845|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.899|TWO_SIDED|95.0|-1.04|0.91||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.91|-1.04|0.899
71121854|NCT04411420|141749845|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.946|TWO_SIDED|95.0|-1.01|1.08||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||1.08|-1.01|0.946
71121855|NCT04411420|141749846|SUPERIORITY||Odds Ratio, log|-0.004||||0.992|TWO_SIDED|95.0|-4.62|4.61||P-value is not adjusted for multiple comparisons. Threshold for significance is 0.05.|Regression, Logistic|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Odds Ratio calculated for Integrated Sequenced Care Pathway relative to Coordinated Care Management Pathway.|||4.61|-4.62|0.992
71083259|NCT04085601|141672767|SUPERIORITY||LS mean difference|21.75||||0.0006|TWO_SIDED|95.0|9.35|34.16||P-value for baseline, strata and treatment is from LS mean of proc mixed and proc mianalyze based on parameter estimates.|ANCOVA|||||34.16|9.35|0.0006
71083260|NCT04085601|141672768|SUPERIORITY||LS mean difference|55.79||||0.005|TWO_SIDED|95.0|16.83|94.74||P-value for baseline, strata and treatment is from LS mean of proc mixed and proc mianalyze based on parameter estimates.|ANCOVA|||||94.74|16.83|0.005
71083261|NCT04085601|141672769|SUPERIORITY||Difference|0.4639||||0.0002|TWO_SIDED|95.0|0.2529|0.675||Cochran-Mantel-Haenszel test is stratified by number of PRBC within 12 months prior to screening (\<4, ≥ 4) reported in EDC data.|Cochran-Mantel-Haenszel|||||0.675|0.2529|0.0002
71083262|NCT04085601|141672770|SUPERIORITY||Stratified Hazard Ratio|0.02|||<|0.0001|TWO_SIDED|95.0|0.004|0.091||Hazard ratio is based on cox proportional hazards model.|Stratified Wilcoxon|||||0.091|0.004|<0.0001
71121856|NCT04411420|141749847|SUPERIORITY||Median Difference (Final Values)|-2.67||||0.262|TWO_SIDED|95.0|-7.52|2.18||P-value is not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|||2.18|-7.52|0.262
71121857|NCT04411420|141749848|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.37|TWO_SIDED|97.5|-1.31|0.5||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.50|-1.31|0.37
71121858|NCT04411420|141749848|SUPERIORITY||Mean Difference (Final Values)|-0.57||||0.24|TWO_SIDED|97.5|-1.54|0.39||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.39|-1.54|0.24
71121859|NCT04411420|141749848|SUPERIORITY||Mean Difference (Final Values)|-0.45||||0.37|TWO_SIDED|97.5|-1.43|0.54|||Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.54|-1.43|0.37
71121860|NCT04411420|141749849|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.727|TWO_SIDED|97.5|-0.51|0.72||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.72|-0.51|0.727
71121861|NCT04411420|141749849|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.478|TWO_SIDED|97.5|-0.43|0.91||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.91|-0.43|0.478
70944420|NCT00510146|141388876|SUPERIORITY_OR_OTHER|||||||0.13||95.0||||p-value represents change from baseline to endpoint for cholesterol from t-tests on change.|t-test, 2 sided|||||||0.130
71083263|NCT04085601|141672771|SUPERIORITY||Stratified Hazard Ratio|0.025|||<|0.0001|TWO_SIDED|95.0|0.005|0.121|||Stratified Wilcoxon|||||0.121|0.005|<0.0001
71083264|NCT03492437|141672772|OTHER||Ratio of Geometric Least square Mean|151.38|||||TWO_SIDED|90.0|127.35|179.93||||||||179.93|127.35|
71083265|NCT03492437|141672773|OTHER||Ratio of Geometric Least square Mean|144.7|||||TWO_SIDED|90.0|122.89|170.39||||||||170.39|122.89|
71121862|NCT04411420|141749849|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.894|TWO_SIDED|97.5|-0.75|0.66||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.66|-0.75|0.894
71121863|NCT04411420|141749850|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.222|TWO_SIDED|95.0|-0.15|0.04||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.04|-0.15|0.222
71121864|NCT04411420|141749850|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.988|TWO_SIDED|95.0|-0.1|0.09||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.09|-0.10|0.988
71121865|NCT04411420|141749850|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.269|TWO_SIDED|95.0|-0.16|0.05||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.05|-0.16|0.269
71121866|NCT04411420|141749851|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.477|TWO_SIDED|95.0|-0.22|0.1||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.10|-0.22|0.477
71083266|NCT03492437|141672774|OTHER||Ratio of Geometric Least square Mean|138.45|||||TWO_SIDED|90.0|121.59|157.65||||||||157.65|121.59|
71121867|NCT04411420|141749851|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.877|TWO_SIDED|95.0|-0.19|0.17||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.17|-0.19|0.877
70855900|NCT04575597|141198558|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.38|1.78||||||||1.78|0.38|
70855901|NCT04575597|141198558|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.25|1.39||||||||1.39|0.25|
70855902|NCT04575597|141198558|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.91|1.48||||||||1.48|0.91|
71083267|NCT03492437|141672775|OTHER||Median Difference (Net)|0.5|||||TWO_SIDED|90.0|-0.3|1.0||||||||1.0|-0.3|
71083268|NCT02418234|141672786|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
71083269|NCT02418234|141672787|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71121868|NCT04411420|141749851|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.36|TWO_SIDED|95.0|-0.29|0.11|||Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.11|-0.29|0.360
71121869|NCT04411420|141749852|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.858|TWO_SIDED|95.0|-0.23|0.28||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.28|-0.23|0.858
71121870|NCT04411420|141749852|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.688|TWO_SIDED|95.0|-0.32|0.21||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.21|-0.32|0.688
71121871|NCT04411420|141749852|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.833|TWO_SIDED|95.0|-0.32|0.26||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.26|-0.32|0.833
71121872|NCT04411420|141749853|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.259|TWO_SIDED|95.0|-0.18|0.64||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.64|-0.18|0.259
70855903|NCT04575597|141198559|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.26|1.34||||||||1.34|0.26|
70855904|NCT04575597|141198559|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.28|1.37||||||||1.37|0.28|
70944421|NCT00510146|141388876|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||p-value represents change from baseline to endpoint for triglycerides from t-tests on change.|t-test, 2 sided|||||||0.055
71083270|NCT04534517|141672788|SUPERIORITY|The superiority of the Test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold 32 points|Mean Estimate|58.6|STANDARD_DEVIATION|3.26|||TWO_SIDED|95.0|52.3|64.9|||Bayesian multivariate random-effects||Included Hyperope group only|It was calculated that 60 participants would have \> 99% power to for the mean CLUE vision scores for each sphere stratum to be above the hypothesis threshold at the 2-week follow-up. Sample size was determined using one sample means test for equivalence||64.9|52.3|
71121873|NCT04411420|141749853|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.068|TWO_SIDED|95.0|-0.03|0.81||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.81|-0.03|0.068
70944422|NCT00510146|141388876|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||p-value represents change from baseline to endpoint for LDL cholesterol from t-tests on change.|t-test, 2 sided|||||||0.049
70944423|NCT00510146|141388876|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents change from baseline to endpoint for HDL cholesterol from t-tests on change.|t-test, 2 sided|||||||<0.001
71083271|NCT04534517|141672788|SUPERIORITY|The superiority of the Test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold 40 points for Myopes|Mean Estimate|63.8|STANDARD_DEVIATION|2.97|||TWO_SIDED|95.0|57.9|69.6|||Bayesian multivariate random-effects||Included myope group only.|It was calculated that 60 participants would have \> 99% power to for the mean CLUE vision scores for each sphere stratum to be above the hypothesis threshold at the 2-week follow-up. Sample size was determined using one sample means test for equivalence||69.6|57.9|
70855905|NCT04575597|141198559|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.38|1.74||||||||1.74|0.38|
70855906|NCT04575597|141198559|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.79|1.21||||||||1.21|0.79|
70855907|NCT04575597|141198560|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.47|3.02||||||||3.02|0.47|
70855908|NCT04575597|141198560|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.29|2.2||||||||2.20|0.29|
70855909|NCT04575597|141198560|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.32|2.45||||||||2.45|0.32|
70855910|NCT04575597|141198560|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.62|1.11||||||||1.11|0.62|
70855911|NCT04575597|141198561|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.3|2.27||||||||2.27|0.30|
70855912|NCT04575597|141198561|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.21|||||TWO_SIDED|95.0|0.04|1.0||||||||1.00|0.04|
70855913|NCT04575597|141198561|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.23|1.91||||||||1.91|0.23|
70944424|NCT00510146|141388877|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||p-value represents change from baseline to endpoint for QTcF from t-test.|t-test, 2 sided|||||||0.023
70855914|NCT04575597|141198561|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.62|1.23||||||||1.23|0.62|
70855915|NCT04575597|141198562|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.28|1.2||||||||1.20|0.28|
70855916|NCT04575597|141198562|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.2|0.95||||||||0.95|0.20|
70855917|NCT04575597|141198562|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.43|1.59||||||||1.59|0.43|
70855918|NCT04575597|141198562|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.73|1.19||||||||1.19|0.73|
70855919|NCT04575597|141198563|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.35|2.11||||||||2.11|0.35|
70855920|NCT04575597|141198563|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.16|1.34||||||||1.34|0.16|
70855921|NCT04575597|141198563|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.5|2.79||||||||2.79|0.50|
70855922|NCT04575597|141198563|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.74|1.32||||||||1.32|0.74|
70855923|NCT04575597|141198564|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.06|15.54||||||||15.54|0.06|
71121874|NCT04411420|141749853|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.514|TWO_SIDED|95.0|-0.29|0.57||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.57|-0.29|0.514
71121875|NCT04411420|141749854|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.895|TWO_SIDED|95.0|-0.22|0.2||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.20|-0.22|0.895
71121876|NCT04411420|141749854|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.438|TWO_SIDED|95.0|-0.13|0.3||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.30|-0.13|0.438
71121877|NCT04411420|141749854|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.89|TWO_SIDED|95.0|-0.24|0.21||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.21|-0.24|0.890
71121878|NCT04411420|141749855|SUPERIORITY||Median Difference (Final Values)|-0.01||||0.508|TWO_SIDED|95.0|-0.04|0.02||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.02|-0.04|0.508
71121879|NCT04411420|141749855|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.992|TWO_SIDED|95.0|-0.03|0.03||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.03|-0.03|0.992
71121880|NCT04411420|141749855|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.389|TWO_SIDED|95.0|-0.05|0.02||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.02|-0.05|0.389
71121881|NCT00628589|141749859|SUPERIORITY|LS mean was used in the primary efficacy analysis||||||0.0004|||||||ANCOVA|p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model||||||0.0004
71121882|NCT00628589|141749859|SUPERIORITY||||||<|0.0001|||||||ANCOVA|p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model||||||<0.0001
71121883|NCT00628589|141749860|SUPERIORITY|||||||0.0015|||||||Fisher Exact|||||||0.0015
71121884|NCT00628589|141749860|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71121885|NCT00628589|141749861|SUPERIORITY|||||||0.0015|||||||Fisher Exact|||||||0.0015
71121886|NCT00628589|141749861|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71121887|NCT01151761|141749862|SUPERIORITY_OR_OTHER||months|8.5|||||TWO_SIDED|95.0|7.0|10.0|||||There were only two patients in the study. Both died without having any local failure. One patient died at 10 months, the other at 7 months. The range for the 95%CI is both the full range and the 95%CI.|The median Progression Free Survival (PFS) time as calculated using Kaplan Meier methodology. For PFS both death and progression are counted as events.||10|7|
71121888|NCT01151761|141749867|SUPERIORITY_OR_OTHER||proportion of participants|0.0|||||TWO_SIDED||||||||None of the two patients who participated had a local recurrence before they died.|||||
71121889|NCT01030874|141749875|OTHER||Odds Ratio (OR)|1.16||||0.6|TWO_SIDED|95.0|0.67|1.99|||Regression, Logistic|Adjusted for whether patient had orthostatic hypotension at baseline.|Arm 2 is in the numerator of OR calculation.|||1.99|0.67|0.6
71121890|NCT01030874|141749876|OTHER||Odds Ratio (OR)|1.53||||0.3|TWO_SIDED|95.0|0.74|3.24|||Regression, Logistic|Adjusted for whether patient had orthostatic hypotension at discharge.|Arm 2 is in the numerator of OR calculation.|||3.24|0.74|0.3
71121891|NCT05257148|141749877|SUPERIORITY||Mean Difference (Final Values)|-9.3|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71121892|NCT01891344|141749923|SUPERIORITY||Cox Proportional Hazard|0.273|||||TWO_SIDED|95.0|0.17|0.437||||||||0.437|0.170|
71121893|NCT01891344|141749923|SUPERIORITY||Cox Proportional Hazard|0.61|||||TWO_SIDED|95.0|0.428|0.871||||||||0.871|0.428|
71121894|NCT02590562|141749998|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||F test|||||||<0.0001
71121895|NCT02590562|141749999|SUPERIORITY_OR_OTHER|||||||0.0108|TWO_SIDED||||||F test|||||||0.0108
70855924|NCT04575597|141198564|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.0|||||TWO_SIDED|95.0|0.0||NA = Upper limit not reached as no events were recorded||||||||0.00|
70855925|NCT04575597|141198564|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.06|15.99||||||||15.99|0.06|
70855926|NCT04575597|141198564|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.46|1.25||||||||1.25|0.46|
70855927|NCT04575597|141198565|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|0.58|3.83||||||||3.83|0.58|
71121896|NCT01229943|141750012|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8||||0.12|TWO_SIDED|95.0|0.55|1.17||Tests were stratified by: prior treatment with cytotoxic chemotherapy (no vs yes), prior use of octreotide (no vs yes), and prior therapy with sunitinib (no vs yes).|Log Rank|||Based on the log rank test, with 130 patients enrolled over 22 months and followed an additional 24 months, the difference in median PFS between 9 months and 14 months can be detected with approximately 90% power (1-sided, α=0.15).||1.17|0.55|0.12
71121897|NCT02961790|141750062|SUPERIORITY|||||||0.0041|||||||Kruskal-Wallis|||||||0.0041
71121898|NCT02961790|141750062|SUPERIORITY|||||||0.0001|||||||Kruskal-Wallis|||||||0.0001
71121899|NCT02961790|141750063|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Adjusted for effects specified in outcome measure description.||||||<0.0001
71121900|NCT02961790|141750064|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Adjusted for effects specified in outcome measure description.||||||<0.0001
71121901|NCT02961790|141750065|SUPERIORITY|||||||0.0174|||||||Kruskal-Wallis|||||||0.0174
71121902|NCT02961790|141750065|SUPERIORITY|||||||0.0279|||||||Kruskal-Wallis|||||||0.0279
71121903|NCT02961790|141750066|SUPERIORITY|||||||0.0011|||||||Kruskal-Wallis|||||||0.0011
71121904|NCT02961790|141750066|SUPERIORITY|||||||0.0025|||||||Kruskal-Wallis|||||||0.0025
71121905|NCT02042534|141750071|SUPERIORITY_OR_OTHER|||||||0.6765|||||||Chi-squared|||||||0.6765
71121906|NCT02042534|141750072|SUPERIORITY_OR_OTHER|||||||0.3753|||||||Chi-squared|||||||0.3753
71121907|NCT02042534|141750073|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test||||||<.0001
71121908|NCT02042534|141750074|SUPERIORITY_OR_OTHER|||||||0.3301|||||||Cochran-Mantel-Haenszel|||||||0.3301
71121909|NCT00598078|141750082|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||ANOVA|||||||0.013
71121910|NCT00598078|141750082|SUPERIORITY_OR_OTHER|||||||0.713||95.0|||||ANOVA|||||||0.713
71121911|NCT00598078|141750082|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||ANOVA|||||||0.038
71121912|NCT02370641|141750098|OTHER||Mean Difference (Final Values)|-4.0||||0.012|TWO_SIDED|||||p\<0.05 is defined as significant|Wilcoxon (Mann-Whitney)|||Comparison was made to week 4 minus baseline change of phylum Firmicutes abundance between urolithin excretors and non excretors||||0.012
70855928|NCT04575597|141198565|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.42|3.05||||||||3.05|0.42|
70855929|NCT04575597|141198565|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|0.57|3.93||||||||3.93|0.57|
70855930|NCT04575597|141198565|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.61|1.1||||||||1.10|0.61|
70944425|NCT00510146|141388877|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||p-value represents change from baseline to endpoint for QTcB from t-test.|t-test, 2 sided|||||||0.044
71083272|NCT04534517|141672789|SUPERIORITY|The superiority of the Test lens was concluded if the upper credible limit of the mean was below the pre-defined threshold +0.10 logMAR for Distance|Mean estimate|-0.09|STANDARD_DEVIATION|0.0172|||TWO_SIDED|95.0|-0.125|-0.057|||Bayesian normal random-effects model|Repeated Measures||It was calculated that 60 participants would have \> 99% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 2-week follow-up. Sample size was determined using one sample means test for equivalence||-0.057|-0.125|
71083273|NCT04534517|141672789|SUPERIORITY|The superiority of the Test lens was concluded if the upper credible limit of the mean was below the pre-defined threshold +0.17 logMAR for Intermediate|Mean Estimate|-0.057|STANDARD_DEVIATION|0.0171|||TWO_SIDED|95.0|-0.091|-0.024|||Bayesian normal random-effects model|Repeated Measures||It was calculated that 60 participants would have \> 99% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 2-week follow-up. Sample size was determined using one sample means test for equivalence||-0.024|-0.091|
71083274|NCT04534517|141672789|SUPERIORITY|The superiority of the Test lens was concluded if the upper credible limit of the mean was below the pre-defined threshold +0.17 logMAR for Near|Mean Estimate|0.066|STANDARD_DEVIATION|0.0171|||TWO_SIDED|95.0|0.031|0.098|||Bayesian normal random-effects model|Repeated Measures||It was calculated that 60 participants would have \> 99% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 2-week follow-up. Sample size was determined using one sample means test for equivalence||0.098|0.031|
71083275|NCT04534517|141672790|SUPERIORITY|A superiority margin of 5% was used. Upper limit of 95% credible interval was compared to 5%.|Mean Proportion|0.001|STANDARD_DEVIATION|0.0012|||TWO_SIDED|95.0|0.0|0.004|||Bayesian beta-binomial model|Correlated Binary Data||||0.004|0.000|
71083276|NCT04534517|141672791|SUPERIORITY|A superiority margin of 5% was used. Upper limit of the 95% credible interval was compared to 5%|Mean Proportion|0.005|STANDARD_DEVIATION|0.0048|||TWO_SIDED|95.0|0.0|0.018|||Bayesian beta-binomial model|Correlated Binary Data||||0.018|0.000|
71083277|NCT04534517|141672792|SUPERIORITY|A superiority margin of 90% was used. Lower limit of the 95% credible interval was compared to 90%|Mean Proportion|0.992|STANDARD_DEVIATION|0.0072|||TWO_SIDED|95.0|0.973|0.999|||Bayesian beta-binomial model|Correlated Binary Data||||0.999|0.973|
71083278|NCT00823264|141672796|SUPERIORITY_OR_OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|||||||0.049
71083279|NCT05133323|141672797|SUPERIORITY||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.89||0.0106|ONE_SIDED|90.0||-0.6|||ANCOVA|||||-0.6||0.0106
71083280|NCT00113295|141672801|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.3|||<|0.05||||||No adjustment for multiple testing|t-test, 2 sided||This analysis applies to the additional reduction from phase 2 randomization to phase 2 endpoint in HAM-A scores.|In phase 2, comprising randomized double-blind quetiapine augmentation, change scores were examined with two-tailed, two-sample t tests, utilizing scores at phase 2 randomization as baseline. All analyses were intention to treat (ITT) with the last visit carried forward (LVCF) for subjects that did not complete the study.||||<0.05
71121913|NCT02370641|141750098|OTHER||Mean Difference (Final Values)|2.6||||0.009|TWO_SIDED|||||p\<0.05 was defined as significant|Wilcoxon (Mann-Whitney)|||Comparison was made to week 4 minus baseline change of phylum Proteobacteria abundance between urolithin excretors and non excretors||||0.009
71121914|NCT02133664|141750099|SUPERIORITY||Mean Difference (Final Values)|1.14|STANDARD_ERROR_OF_MEAN|1.57||0.05|TWO_SIDED|95.0|-2.03|4.32|||t-test, 2 sided|||With the initial sample size plan of 53 subjects, we expect an 80% power to detect a significant difference in PASAT score with a mean difference of 8.3 points between the treatment and placebo group.||4.32|-2.03|0.05
70855931|NCT04575597|141198566|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.36|||||TWO_SIDED|95.0|0.11|1.21||||||||1.21|0.11|
70855932|NCT04575597|141198566|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.52|||||TWO_SIDED|95.0|0.2|1.36||||||||1.36|0.20|
70855933|NCT04575597|141198566|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.29|1.89||||||||1.89|0.29|
71083281|NCT00572455|141672813|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|3.02||||0.028|TWO_SIDED|90.0|0.78|5.25|||ANCOVA|||Analysis was based on analysis of covariance (ANCOVA) model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||5.25|0.78|0.028
71083282|NCT00572455|141672813|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.73|||<|0.001|TWO_SIDED|90.0|2.5|6.96|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.96|2.50|<0.001
71121915|NCT00300482|141750103|SUPERIORITY_OR_OTHER||||||<|0.001||||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide \>99% power to detect a 17% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%||||<0.001
70855934|NCT04575597|141198566|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.68|1.2||||||||1.20|0.68|
70944426|NCT00510146|141388878|SUPERIORITY_OR_OTHER|||||||0.919||95.0||||p-value represents change from baseline to endpoint for heart rate from t-test.|t-test, 2 sided|||||||0.919
70855935|NCT04575597|141198567|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.35|||||TWO_SIDED|95.0|0.09|1.33||||||||1.33|0.09|
70855936|NCT04575597|141198567|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.3|2.15||||||||2.15|0.30|
70855937|NCT04575597|141198567|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.18|1.48||||||||1.48|0.18|
70855938|NCT04575597|141198567|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.62|1.04||||||||1.04|0.62|
70855939|NCT04575597|141198568|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|3.04|||||TWO_SIDED|95.0|0.59|15.59||||||||15.59|0.59|
70855940|NCT04575597|141198568|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.29|6.16||||||||6.16|0.29|
70855941|NCT04575597|141198568|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.37|||||TWO_SIDED|95.0|0.09|1.44||||||||1.44|0.09|
70855942|NCT04575597|141198568|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.62|2.3||||||||2.30|0.62|
70855943|NCT04575597|141198569|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|3.67|||||TWO_SIDED|95.0|1.14|11.88||||||||11.88|1.14|
70944427|NCT02864342|141388915|OTHER||||||<|0.001|||||||Satterthwaite t-test|||The effect of medication reminders on Symbicort adherence was evaluated using a t-test. The equality of variances was also tested and as the variances were not equal, the Satterthwaite-t test was reported.||||<0.001
70855944|NCT04575597|141198569|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.34|3.98||||||||3.98|0.34|
71083283|NCT00572455|141672813|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.56|||<|0.001|TWO_SIDED|90.0|4.33|8.79|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.79|4.33|<0.001
71083284|NCT00572455|141672813|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.78|||<|0.001|TWO_SIDED|90.0|3.6|7.95|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.95|3.60|<0.001
71083285|NCT00572455|141672813|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.06|||<|0.001|TWO_SIDED|90.0|2.74|7.37|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.37|2.74|<0.001
71083286|NCT00572455|141672813|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.02|||<|0.001|TWO_SIDED|90.0|3.79|8.25|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.25|3.79|<0.001
71121916|NCT00300482|141750103|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide \>99% power to detect a 17% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%||||<0.001
71121917|NCT00300482|141750104|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide 92% power to detect a 5% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
71121918|NCT00300482|141750104|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide 92% power to detect a 5% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
71121919|NCT00300482|141750105|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide 99% power to detect a 43% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
71121920|NCT00300482|141750105|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide 99% power to detect a 43% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
71121921|NCT02120365|141750111|SUPERIORITY||Mean Difference (Final Values)|0.729|STANDARD_ERROR_OF_MEAN|1.986||0.867|TWO_SIDED||||||Mixed Models Analysis||Representing the high dose 10mg compared to the placebo 0mg dose.|Medication dose was a within-subjects factor (crossover design)||||0.867
71121922|NCT02120365|141750112|SUPERIORITY||Mean Difference (Final Values)|5.514|STANDARD_ERROR_OF_MEAN|3.038||0.071|TWO_SIDED||||||Mixed Models Analysis||Representing the high dose 10mg compared to the placebo 0mg dose.|mixed models, medication was a within-subjects factor||||0.071
71121923|NCT02120365|141750113|SUPERIORITY||Mean Difference (Final Values)|0.729|STANDARD_ERROR_OF_MEAN|2.905||0.667|TWO_SIDED||||||Mixed Models Analysis||Representing the high dose 10mg compared to the placebo 0mg dose.|mixed models||||0.667
71121924|NCT02120365|141750114|SUPERIORITY||Mean Difference (Final Values)|2.242|STANDARD_ERROR_OF_MEAN|1.393||0.285|TWO_SIDED||||||Mixed Models Analysis||Representing the high dose 10mg compared to the placebo 0mg dose.|||||0.285
71121925|NCT02120365|141750115|SUPERIORITY||Mean Difference (Final Values)|0.235|STANDARD_ERROR_OF_MEAN|0.408||0.843|TWO_SIDED||||||Mixed Models Analysis||Representing the high dose 10mg compared to the placebo 0mg dose.|Mixed Models||||.843
71121926|NCT02120365|141750116|SUPERIORITY||Mean Difference (Final Values)|0.369|STANDARD_ERROR_OF_MEAN|2.07||0.691|TWO_SIDED||||||Mixed Models Analysis||Representing the high dose 10mg compared to the placebo 0mg dose.|We report the main effect of dose on the outcome measure||||.691
71121927|NCT01726673|141750117|EQUIVALENCE|Statistical analysis of median change from baseline to DC immediately following 12 weeks of training was assessed with the upper extremity fugl meyer score in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in upper extremity fugl meyer score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|302.0||||0.256|TWO_SIDED|||||The Mann-Whitney U test was performed to compare median change in upper extremity fugl meyer score from baseline to 12 weeks (discharge) across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U test|||||||0.256
71121928|NCT01726673|141750117|EQUIVALENCE|Statistical analysis of median change from baseline to week 36 (6 month follow-up) was assessed with upper extremity fugl meyer score for the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in upper extremity fugl meyer score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|222.0||||0.222|TWO_SIDED|||||The Mann-Whitney U test was performed to compare median change in upper extremity fugl meyer score from baseline to 36 weeks (follow-up) across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U test|||||||0.222
71121929|NCT01726673|141750118|EQUIVALENCE|Statistical analysis of median change from baseline to DC immediately following 12 weeks of training was assessed with the WOLF Motor Function test time score (out of 1800 seconds) in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in WMFT time score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U Value|251.5||||1|TWO_SIDED|||||The Mann-Whitney U test was performed to compare median change in the WMFT time score from baseline to 12 weeks (discharge) across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U Test|||||||1.0
71083287|NCT00572455|141672814|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.06||||0.171|TWO_SIDED|90.0|-0.21|2.32|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.32|-0.21|0.171
71083288|NCT00572455|141672814|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.45||||0.553|TWO_SIDED|90.0|-0.8|1.7|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.70|-0.80|0.553
71083289|NCT00572455|141672814|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.45||||0.555|TWO_SIDED|90.0|-0.8|1.7|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.70|-0.80|0.555
71083290|NCT00572455|141672814|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.48||||0.053|TWO_SIDED|90.0|0.22|2.73|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.73|0.22|0.053
71083291|NCT00572455|141672814|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.54|||<|0.001|TWO_SIDED|90.0|1.29|3.8|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.80|1.29|<0.001
71083292|NCT00572455|141672814|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.81||||0.018|TWO_SIDED|90.0|0.56|3.07|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to Latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.07|0.56|0.018
71083293|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.62||||0.011|TWO_SIDED|90.0|1.34|5.9|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||5.90|1.34|0.011
71083294|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.19||||0.004|TWO_SIDED|90.0|1.91|6.47|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.47|1.91|0.004
71083295|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.47|||<|0.001|TWO_SIDED|90.0|4.19|8.75|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.75|4.19|<0.001
71083296|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.32|||<|0.001|TWO_SIDED|90.0|3.11|7.54|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.54|3.11|<0.001
71083297|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.0|||<|0.001|TWO_SIDED|90.0|3.66|8.33|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.33|3.66|<0.001
71083298|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.8|||<|0.001|TWO_SIDED|90.0|3.52|8.08|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.08|3.52|<0.001
71083299|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.44||||0.12|TWO_SIDED|90.0|-0.14|5.02|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||5.02|-0.14|0.120
71083300|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.55||||0.005|TWO_SIDED|90.0|1.97|7.14|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.14|1.97|0.005
71083301|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.17|||<|0.001|TWO_SIDED|90.0|3.58|8.75|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.75|3.58|<0.001
71083302|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.03|||<|0.001|TWO_SIDED|90.0|3.52|8.54|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.54|3.52|<0.001
71083303|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|7.31|||<|0.001|TWO_SIDED|90.0|4.66|9.95|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.95|4.66|<0.001
71083304|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.5|||<|0.001|TWO_SIDED|90.0|2.91|8.08|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its Vehicle with treatment and baseline IOP as covariates.||8.08|2.91|<0.001
71083305|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.04||||0.009|TWO_SIDED|90.0|1.56|6.53|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.53|1.56|0.009
71083306|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|7.0|||<|0.001|TWO_SIDED|90.0|4.49|9.5|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.50|4.49|<0.001
71083307|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|7.61|||<|0.001|TWO_SIDED|90.0|5.11|10.11|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||10.11|5.11|<0.001
71083308|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|7.08|||<|0.001|TWO_SIDED|90.0|4.64|9.53|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.53|4.64|<0.001
70944428|NCT02725008|141388950|SUPERIORITY||Odds Ratio (OR)|2.32||||0.3|TWO_SIDED|95.0|0.54|10.07|||Chi-squared|||||10.07|0.54|0.3
71083309|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.01|||<|0.001|TWO_SIDED|90.0|3.4|8.62|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.62|3.40|<0.001
71083310|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|8.7|||<|0.001|TWO_SIDED|90.0|6.11|11.3|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||11.30|6.11|<0.001
71083311|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.66||||0.066|TWO_SIDED|90.0|0.29|5.02|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||5.02|0.29|0.066
71083312|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.13||||0.006|TWO_SIDED|90.0|1.76|6.5|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.50|1.76|0.006
71083313|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.13|||<|0.001|TWO_SIDED|90.0|3.76|8.49|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.49|3.76|<0.001
71083314|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.81|||<|0.001|TWO_SIDED|90.0|3.51|8.11|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.11|3.51|<0.001
71083315|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.02||||0.01|TWO_SIDED|90.0|1.53|6.5|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.50|1.53|0.010
71083316|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.48|||<|0.001|TWO_SIDED|90.0|3.03|7.93|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.93|3.03|<0.001
71083317|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.55||||0.006|TWO_SIDED|90.0|1.91|7.19|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.19|1.91|0.006
70944429|NCT02725008|141388951|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||||||0.95
70944430|NCT01149876|141388952|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.05
71083318|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.3||||0.002|TWO_SIDED|90.0|2.66|7.94|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.94|2.66|0.002
71083319|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|7.51|||<|0.001|TWO_SIDED|90.0|4.87|10.16|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||10.16|4.87|<0.001
71083320|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|9.14|||<|0.001|TWO_SIDED|90.0|6.57|11.71|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||11.71|6.57|<0.001
71083321|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.69||||0.002|TWO_SIDED|90.0|2.94|8.44|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.44|2.94|0.002
71083322|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.89|||<|0.001|TWO_SIDED|90.0|4.16|9.62|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.62|4.16|<0.001
70944431|NCT01149876|141388952|SUPERIORITY_OR_OTHER|||||||0.25|||||||t-test, 2 sided|||||||.25
70944432|NCT01149876|141388952|SUPERIORITY_OR_OTHER|||||||0.48|||||||t-test, 2 sided|||||||.48
70944433|NCT00513461|141388954|SUPERIORITY||Mean Difference (Net)|7.78||||0.16|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.160
70944434|NCT00513461|141388967|SUPERIORITY||Mean Difference (Net)|0.43||||0.878|TWO_SIDED||||||Two-Group t-test|||||||0.878
70944435|NCT00513461|141388968|SUPERIORITY||Mean Difference (Net)|-3.66||||0.212|TWO_SIDED||||||Two-Group t-test|||||||0.212
70855945|NCT04575597|141198569|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.27|2.68||||||||2.68|0.27|
70855946|NCT04575597|141198569|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.52|||||TWO_SIDED|95.0|0.96|2.39||||||||2.39|0.96|
70855947|NCT04575597|141198570|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.68|||||TWO_SIDED|95.0|0.82|3.45||||||||3.45|0.82|
70855948|NCT04575597|141198570|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.55|2.33||||||||2.33|0.55|
70855949|NCT04575597|141198570|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.59|||||TWO_SIDED|95.0|0.27|1.29||||||||1.29|0.27|
70855950|NCT04575597|141198570|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.58|||||TWO_SIDED|95.0|1.14|2.2||||||||2.20|1.14|
70855951|NCT04575597|141198571|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.41|||||TWO_SIDED|95.0|0.73|2.73||||||||2.73|0.73|
70855952|NCT04575597|141198571|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.52|1.94||||||||1.94|0.52|
71083323|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.83||||0.269|TWO_SIDED|90.0|-0.91|4.58|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||4.58|-0.91|0.269
71083324|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.49||||0.009|TWO_SIDED|90.0|1.75|7.24|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.24|1.75|0.009
70855953|NCT04575597|141198571|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.34|1.32||||||||1.32|0.34|
70855954|NCT04575597|141198571|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.36|||||TWO_SIDED|95.0|1.03|1.78||||||||1.78|1.03|
70855955|NCT04575597|141198572|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.35|1.66||||||||1.66|0.35|
70855956|NCT04575597|141198572|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.38|1.79||||||||1.79|0.38|
71121930|NCT01726673|141750118|EQUIVALENCE|Statistical analysis of median change from baseline to week 36 (6 month follow-up) was assessed with the WOLF Motor Function test time score (out of 1800 seconds) in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in WMFT time score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|208.5||||0.592|TWO_SIDED|||||The Mann-Whitney U test was performed to compare median change in the WMFT time score from baseline to 36 weeks ( 6 month follow-up) across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U Test|||||||0.592
71121931|NCT01726673|141750119|EQUIVALENCE|Statistical analysis of median change from baseline to DC immediately following 12 weeks of training was assessed with the Motor Power Manual Muscle Test Score for the upper extremity (out of 100 points) in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in MRC score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|270.5||||0.68|TWO_SIDED|||||The Mann-Whitney U test was performed to compare median change in the MRC score from baseline to 12 weeks (discharge) across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U test|||||||0.680
70855957|NCT04575597|141198572|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.37|1.81||||||||1.81|0.37|
71121932|NCT01726673|141750119|EQUIVALENCE|Statistical analysis of median change from baseline to week 36 (6 month FU) was assessed with the Motor Power Manual Muscle Test Score for the upper extremity (out of 100 points) in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in MRC score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|187.5||||0.837|TWO_SIDED|||||The Mann-Whitney U test was performed to compare median change in the MRC score from baseline to 6 month FU across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U Test|||||||0.837
71121933|NCT01719003|141750120|SUPERIORITY_OR_OTHER||Adjusted mean|-0.33|STANDARD_ERROR_OF_MEAN|0.12||0.0056|TWO_SIDED|95.0|-0.56|-0.1|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.10|-0.56|0.0056
70855958|NCT04575597|141198572|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.84|1.29||||||||1.29|0.84|
70855959|NCT04575597|141198573|OTHER|Difference in rates % and associated CIs were based on the Miettinen \& Nurminen method stratified by randomization strata. Unknown survival status at Day 29 was treated as failure.|Difference in Rates %|-3.0|||||TWO_SIDED|95.0|-5.9|-0.1||||||||-0.1|-5.9|
70855960|NCT03207438|141198574|SUPERIORITY||Hazard Ratio (HR)|1.39|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED||||||Regression, Cox|||Main effect of quetiapine vs. placebo||||<.001
70855961|NCT03207438|141198574|SUPERIORITY||Hazard Ratio (HR)|1.15|STANDARD_ERROR_OF_MEAN|0.1||0.18|TWO_SIDED||||||Regression, Cox|||Interaction - treatment condition x melancholia||||.18
70855962|NCT03207438|141198574|SUPERIORITY||Hazard Ratio (HR)|1.46|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED||||||Regression, Cox|Adjusted for baseline depression severity, Study number (1-4), and melancholic-by-time interaction.||Main effect of quetiapine vs. placebo||||<.001
70855963|NCT03207438|141198574|SUPERIORITY||Hazard Ratio (HR)|1.17|STANDARD_ERROR_OF_MEAN|0.1||0.14|TWO_SIDED||||||Regression, Cox|Adjusted for baseline depression severity, Study number (1-4), and melancholic-by-time interaction.||Interaction - treatment condition by melancholia||||.14
70855964|NCT03207438|141198575|SUPERIORITY||Hazard Ratio (HR)|1.35|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED||||||Regression, Cox|||Main effect of quetiapine vs. placebo||||<.001
70855965|NCT03207438|141198575|SUPERIORITY||Hazard Ratio (HR)|1.16|STANDARD_ERROR_OF_MEAN|0.11||0.17|TWO_SIDED||||||Regression, Cox|||Interaction - treatment condition x melancholia||||.17
70855966|NCT03207438|141198575|SUPERIORITY||Hazard Ratio (HR)|1.3|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED||||||Regression, Cox|Adjusted for baseline depression severity, Study number (1-4), and melancholic-by-time interaction.||Main effect of quetiapine vs. placebo||||<.001
70855967|NCT03207438|141198575|SUPERIORITY||Hazard Ratio (HR)|1.18|STANDARD_ERROR_OF_MEAN|0.11||0.13|TWO_SIDED||||||Regression, Cox|Adjusted for baseline depression severity, Study number (1-4), and melancholic-by-time interaction.||Interaction - treatment condition by melancholia||||.13
70855968|NCT03207438|141198576|SUPERIORITY|||||||0.33|||||||Fisher's exact test|||Day 4 - Fisher's exact test comparing the proportion of quetiapine responders in each sleep subgroup|An exact OR could not be estimated by R; the 95% confidence interval was 0.31 to infinity, p = .33.|||.33
70855969|NCT03207438|141198576|SUPERIORITY||Odds Ratio (OR)|1.3||||0.44|TWO_SIDED||||||Fisher's exact test||The exact limits of 95% confidence interval could not be estimated, it was reported as 0.40 to infinity.|Week 1 - Fisher's exact test comparing the proportion of quetiapine responders in each sleep subgroup||||.44
70944436|NCT02920021|141388983|SUPERIORITY||Least Squares (LS) Mean Difference|60.046|STANDARD_ERROR_OF_MEAN|79.918||0.463|TWO_SIDED|95.0|-108.566|228.657|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline value as covariate.|Treatment Difference = Etokimab - Placebo|||228.657|-108.566|0.463
70855970|NCT03207438|141198576|SUPERIORITY||Chi-squared|0.38||||0.73|TWO_SIDED||||||Chi-squared, Corrected|||Week 2 - Chi-squared test comparing the proportion of quetiapine responders in each sleep subgroup||||.73
70855971|NCT03207438|141198576|SUPERIORITY||Chi-squared|1.5||||0.11|TWO_SIDED||||||Chi-squared, Corrected|||Week 4 - Chi-squared test comparing the proportion of quetiapine responders in each sleep subgroup||||.11
70855972|NCT03207438|141198576|SUPERIORITY||Chi-squared|0.001||||0.5|TWO_SIDED||||||Chi-squared, Corrected||The actual estimated Chi-squared statistic was 6.35(10\^-31)|Week 6 - Chi-squared test comparing the proportion of quetiapine responders in each sleep subgroup||||.50
70855973|NCT03207438|141198577|SUPERIORITY||Chi-squared|0.001||||0.5|TWO_SIDED||||||Chi-squared, Corrected||Estimated chi-squared statistic was 1.88(10\^-29).|Day 4 - chi-squared test comparing response rates between groups.||||.5
70855974|NCT03207438|141198577|SUPERIORITY||Chi-squared|3.3||||0.03|TWO_SIDED||||||Chi-squared, Corrected|||Week 1 - chi-squared test comparing response rates between groups.||||.03
70855975|NCT03207438|141198577|SUPERIORITY||Chi-squared|3.87||||0.02|TWO_SIDED||||||Chi-squared, Corrected|||Week 2 - chi-squared test comparing response rates between groups.||||.02
70855976|NCT03207438|141198577|SUPERIORITY||Chi-squared|0.62||||0.22|TWO_SIDED||||||Chi-squared, Corrected|||Week 4 - chi-squared test comparing response rates between groups.||||.22
70855977|NCT03207438|141198577|SUPERIORITY||Chi-squared|2.45||||0.059|TWO_SIDED||||||Chi-squared, Corrected|||Week 6 - chi-squared test comparing response rates between groups.||||.059
70855978|NCT01512667|141198605|NON_INFERIORITY_OR_EQUIVALENCE|Similarity will be concluded if the GMR (severe renal insufficiency / healthy) is contained within the interval \[0.40, 2.50\].|GMR|1.6|||||TWO_SIDED|90.0|1.15|2.23||||||Natural log-transformed plasma values were analyzed using an analysis of covariance (ANCOVA) model with a categorical factor for population (severe renal insufficiency participants, healthy matched control participants) and continuous covariates for age and body mass index (BMI). Data are back transformed to geometric least-squares mean ratio (GMR) (severe renal insufficiency / healthy) and 90% confidence intervals.||2.23|1.15|
70855979|NCT01512667|141198606|SUPERIORITY_OR_OTHER||GMR|1.46|||||TWO_SIDED|90.0|1.18|1.81||||||Natural log-transformed plasma values were analyzed using an ANCOVA model with a categorical factor for population (severe renal insufficiency participants, healthy matched control participants) and continuous covariates for age and BMI. Data are back transformed to GMR (severe renal insufficiency / healthy) and 90% confidence intervals.||1.81|1.18|
70855980|NCT00853996|141198621|OTHER||||||<|0.001||||||No adjustment for multiple comparisons since this was primary endpoint. A priori threshold for statistical significance was set at \<0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
70855981|NCT00853996|141198622|OTHER|||||||0.067||||||No adjustment for multiple comparisons. A priori threshold for statistical significance was set at \<0.05.|Wilcoxon (Mann-Whitney)|||||||0.067
70855982|NCT00853996|141198623|OTHER|||||||0.001||||||No adjustment for multiple comparisons. A priori threshold for statistical significance was set at \<0.05|Wilcoxon (Mann-Whitney)|||||||0.001
70855983|NCT00853996|141198624|OTHER|||||||0.002||||||No adjustment for multiple comparisons. A priori threshold for statistical significance was set at \<0.05|Wilcoxon (Mann-Whitney)|||||||0.002
70944437|NCT02920021|141388984|SUPERIORITY||LS Mean Difference|0.001|STANDARD_ERROR_OF_MEAN|0.016||0.962|TWO_SIDED|95.0|-0.031|0.032|||ANCOVA|ANCOVA model with treatment as fixed effect and baseline value as covariate.|Treatment Difference = Etokimab - Placebo|||0.032|-0.031|0.962
70855984|NCT00853996|141198625|OTHER|||||||0.002||||||No adjustment for multiple comparisons. A priori threshold for statistical significance set at 0.05|Wilcoxon (Mann-Whitney)|||||||0.002
71083325|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.83|||<|0.001|TWO_SIDED|90.0|4.08|9.57|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.57|4.08|<0.001
71083326|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.18|||<|0.001|TWO_SIDED|90.0|3.52|8.84|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.84|3.52|<0.001
71083327|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.52||||0.002|TWO_SIDED|90.0|2.71|8.33|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.33|2.71|0.002
71083328|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.76|||<|0.001|TWO_SIDED|90.0|4.01|9.5|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.50|4.01|<0.001
71083329|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.36||||0.024|TWO_SIDED|90.0|0.95|5.76|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||5.76|0.95|0.024
71083330|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.24|||<|0.001|TWO_SIDED|90.0|2.82|7.66|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.66|2.82|<0.001
71083331|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.64|||<|0.001|TWO_SIDED|90.0|4.23|9.06|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.06|4.23|<0.001
70944438|NCT05400226|141388994|OTHER|Summary statistics of quantitative data, one-sided exact binomial test for null hypothesis, Clopper-Pearson method for 95% exact confidence intervals|Proportion|0.425|||<|0.0001|TWO_SIDED|95.0|0.27|0.591|||Exact Binomial Test||The Parameter Dispersion Value is the asymptotic standard error of the proportion.|Single arm open-label||0.591|0.270|< .0001
70944439|NCT05400226|141388995|OTHER||Proportion|0.85|||||TWO_SIDED|95.0|0.675|0.939||||||||0.939|0.675|
70944440|NCT05400226|141388996|OTHER||Proportion|0.455|||||TWO_SIDED|95.0|0.202|0.733||||||||0.733|0.202|
70944441|NCT05400226|141388997|OTHER||Proportion|0.333|||||TWO_SIDED|95.0|0.126|0.633||||||||0.633|0.126|
71083332|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.22|||<|0.001|TWO_SIDED|90.0|2.87|7.58|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.58|2.87|<0.001
71083333|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.88||||0.012|TWO_SIDED|90.0|1.39|6.37|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.37|1.39|0.012
71083334|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.98|||<|0.001|TWO_SIDED|90.0|4.48|9.48|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.48|4.48|<0.001
71083335|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.41||||0.003|TWO_SIDED|90.0|2.11|6.72|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.72|2.11|0.003
71083336|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.02|||<|0.001|TWO_SIDED|90.0|2.72|7.33|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.33|2.72|<0.001
71083337|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.58|||<|0.001|TWO_SIDED|90.0|4.27|8.88|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.88|4.27|<0.001
71121934|NCT01719003|141750120|SUPERIORITY_OR_OTHER||Adjusted mean|-0.72|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.95|-0.48|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Empagliflozin 25 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.48|-0.95|<0.0001
71121935|NCT01719003|141750120|SUPERIORITY_OR_OTHER||Adjusted Mean|-0.75|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.98|-0.51|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.51|-0.98|<0.0001
71121936|NCT01719003|141750120|SUPERIORITY_OR_OTHER||Adjusted mean|-0.57|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.81|-0.34|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Empagliflozin 25 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.34|-0.81|<0.0001
71083338|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.54|||<|0.001|TWO_SIDED|90.0|3.31|7.78|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.78|3.31|<0.001
71083339|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.44||||0.003|TWO_SIDED|90.0|2.06|6.82|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.82|2.06|0.003
70944442|NCT05400226|141388998|OTHER||Proportion|0.773|||||TWO_SIDED|95.0|0.65|0.862||||||||0.862|0.650|
71083340|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|7.08|||<|0.001|TWO_SIDED|90.0|4.7|9.47|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.47|4.70|<0.001
71083341|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.41||||0.103|TWO_SIDED|90.0|-0.02|4.84|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||4.84|-0.02|0.103
71083342|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.75||||0.013|TWO_SIDED|90.0|1.32|6.18|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.18|1.32|0.013
71083343|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.96|||<|0.001|TWO_SIDED|90.0|3.53|8.39|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.39|3.53|<0.001
71083344|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.87|||<|0.001|TWO_SIDED|90.0|3.5|8.23|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.23|3.50|<0.001
71083345|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.65|||<|0.001|TWO_SIDED|90.0|3.18|8.11|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.11|3.18|<0.001
71083346|NCT00572455|141672818|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.97|||<|0.001|TWO_SIDED|90.0|3.46|8.48|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.48|3.46|<0.001
71083347|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.72||||0.377|TWO_SIDED|90.0|-0.63|2.08|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.08|-0.63|0.377
71083348|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.68||||0.039|TWO_SIDED|90.0|-3.01|-0.35|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||-0.35|-3.01|0.039
71083349|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.34||||0.668|TWO_SIDED|90.0|-1.67|0.98|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||0.98|-1.67|0.668
71083350|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.26||||0.121|TWO_SIDED|90.0|-0.07|2.59|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.59|-0.07|0.121
70944443|NCT02551692|141389010|OTHER||Partial sum of squares|855.65||||0.534|TWO_SIDED||||||ANOVA|||||||0.534
70944444|NCT02551692|141389011|OTHER||Partial sum of squares|29602.69||||0.26|TWO_SIDED||||||ANOVA|||||||0.26
70944445|NCT02551692|141389012|OTHER||Partial sum of squares|101.69||||0.318|TWO_SIDED||||||ANCOVA|||||||0.318
70855985|NCT00770146|141198633|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤ 0.05.|Wilcoxon (Mann-Whitney)|||Based upon prior clinical study experience with mipomersen, it was estimated that the standard deviation of the percent change in LDL-C is approximately 22%. With at least 20 patients in the control group and 40 patients in the mipomersen-treated group, this study would have at least 90% power to detect a 20% difference between the 2 groups.||||<0.001
71121937|NCT01719003|141750120|SUPERIORITY_OR_OTHER||Adjusted mean|-0.33|STANDARD_ERROR_OF_MEAN|0.12||0.0062|TWO_SIDED|95.0|-0.56|-0.09|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment||-0.09|-0.56|0.0062
71121938|NCT01719003|141750120|SUPERIORITY_OR_OTHER||Adjusted Mean|-0.72|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.95|-0.49|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Empagliflozin 10 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.49|-0.95|<0.0001
71121939|NCT01719003|141750120|SUPERIORITY_OR_OTHER||Adjusted Mean|-0.79|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.03|-0.56|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.56|-1.03|<0.0001
71121940|NCT01719003|141750120|SUPERIORITY_OR_OTHER||Adjusted mean|-0.63|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.86|-0.4|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 500 mg bid minus Empagliflozin 10 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.40|-0.86|<0.0001
71121941|NCT01719003|141750120|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority of empagliflozin 10 mg qd against metformin 1000 mg bid were to be tested for HbA1c change from baseline to Week 24 at the level of α=0.025 (one-sided), through application of a non-inferiority margin of 0.35%.|Adjusted mean|0.39|STANDARD_ERROR_OF_MEAN|0.12||0.6246|TWO_SIDED|95.0|0.15|0.62|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 25 mg qd minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||0.62|0.15|0.6246
71121942|NCT01719003|141750120|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority of empagliflozin 10 mg qd against metformin 1000 mg bid were to be tested for HbA1c change from baseline to Week 24 at the level of α=0.025 (one-sided), through application of a non-inferiority margin of 0.35%.|Adjusted mean|0.4|STANDARD_ERROR_OF_MEAN|0.12||0.6558|TWO_SIDED|95.0|0.16|0.63|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 10 mg qd minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||0.63|0.16|0.6558
71121943|NCT01719003|141750121|SUPERIORITY_OR_OTHER||Adjusted mean|-18.8|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-25.5|-12.2||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-12.2|-25.5|<0.0001
71121944|NCT01719003|141750121|SUPERIORITY_OR_OTHER||Adjusted mean|-23.0|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-29.7|-16.3||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Empagliflozin 25 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-16.3|-29.7|<0.0001
71121945|NCT01719003|141750121|SUPERIORITY_OR_OTHER||Adjusted Mean|-26.7|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-33.5|-20.0||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-20.0|-33.5|<0.0001
70855986|NCT00770146|141198635|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|Wilcoxon (Mann-Whitney)|||||||<0.001
71083351|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.67||||0.039|TWO_SIDED|90.0|0.34|2.99|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.99|0.34|0.039
71083352|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.99||||0.22|TWO_SIDED|90.0|-0.34|2.31|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.31|-0.34|0.220
71083353|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.3||||0.098|TWO_SIDED|90.0|0.01|2.59|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.59|0.01|0.098
71121946|NCT01719003|141750121|SUPERIORITY_OR_OTHER||Adjusted mean|-16.0|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-22.8|-9.2||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Empagliflozin 25 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-9.2|-22.8|<0.0001
71083354|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.5||||0.519|TWO_SIDED|90.0|-0.77|1.77|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.77|-0.77|0.519
71083355|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.27||||0.724|TWO_SIDED|90.0|-1.0|1.55|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.55|-1.00|0.724
71083356|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.46||||0.059|TWO_SIDED|90.0|0.19|2.74|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.74|0.19|0.059
71083357|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.71|||<|0.001|TWO_SIDED|90.0|1.43|3.98|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.98|1.43|<0.001
70954306|NCT02917603|141411104|EQUIVALENCE|Null hypothesis is there will be the mean differences between baseline scores will be the same between groups. Study powered after primary outcome measure.|Mean Difference (Net)|1.02|||<|0.06|TWO_SIDED||||||t-test, 2 sided|||||||<.06
70855987|NCT00770146|141198637|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
70855988|NCT00770146|141198639|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|Wilcoxon (Mann-Whitney)|||||||<0.001
71083358|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.09||||0.008|TWO_SIDED|90.0|0.82|3.37|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.37|0.82|0.008
71083359|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.32||||0.068|TWO_SIDED|90.0|0.13|2.51|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.51|0.13|0.068
71083360|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01||||0.994|TWO_SIDED|90.0|-1.16|1.18|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.18|-1.16|0.994
71083361|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.5||||0.494|TWO_SIDED|90.0|-0.7|1.69|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.69|-0.70|0.494
71083362|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.39||||0.063|TWO_SIDED|90.0|0.16|2.62|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.62|0.16|0.063
71083363|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.15||||0.004|TWO_SIDED|90.0|0.95|3.34|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.34|0.95|0.004
71083364|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.17||||0.004|TWO_SIDED|90.0|0.97|3.38|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.38|0.97|0.004
71083365|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.55||||0.038|TWO_SIDED|90.0|0.32|2.77|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.77|0.32|0.038
71083366|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.48||||0.512|TWO_SIDED|90.0|-0.72|1.68|||ANCOVA|||Change at Day 7 1 PM : Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.68|-0.72|0.512
71083367|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.66||||0.373|TWO_SIDED|90.0|-0.56|1.89|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.89|-0.56|0.373
71083368|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.31||||0.088|TWO_SIDED|90.0|0.05|2.56|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.56|0.05|0.088
71083369|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.21||||0.004|TWO_SIDED|90.0|0.98|3.44|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.44|0.98|0.004
71121947|NCT01719003|141750121|SUPERIORITY_OR_OTHER||Adjusted mean|-15.6|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-22.3|-8.9||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG of double-blind treatment||-8.9|-22.3|<0.0001
71121948|NCT01719003|141750121|SUPERIORITY_OR_OTHER||Adjusted Mean|-14.8|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-21.4|-8.2||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Empagliflozin 10 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-8.2|-21.4|<0.0001
70855989|NCT00770146|141198641|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||<0.001
70855990|NCT00770146|141198643|SUPERIORITY_OR_OTHER|||||||0.977||||||No adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.977
70944446|NCT04159805|141389039|SUPERIORITY||Difference in Least Square (LS) Mean|0.29|||=|0.772|TWO_SIDED|95.0|-1.72|2.3||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||2.30|-1.72|=0.772
71121949|NCT01719003|141750121|SUPERIORITY_OR_OTHER||Adjusted Mean|-28.2|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-35.0|-21.5||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-21.5|-35.0|<0.0001
71121950|NCT01719003|141750121|SUPERIORITY_OR_OTHER||Adjusted mean|-12.6|STANDARD_ERROR_OF_MEAN|3.4||0.0002|TWO_SIDED|95.0|-19.1|-6.0||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 500 mg bid minus Empagliflozin 10 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-6.0|-19.1|0.0002
71121951|NCT01719003|141750122|SUPERIORITY_OR_OTHER||Adjusted mean|-2.5|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-3.33|-1.68||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of body weight after 24 weeks of double-blind treatment.||-1.68|-3.33|<0.0001
71121952|NCT01719003|141750122|SUPERIORITY_OR_OTHER||Adjusted Mean|-2.52|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-3.35|-1.69||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of body weight after 24 weeks of double-blind treatment.||-1.69|-3.35|<0.0001
71121953|NCT01719003|141750122|SUPERIORITY_OR_OTHER||Adjusted mean|-2.2|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-3.03|-1.37||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of body weight after 24 weeks of double-blind treatment||-1.37|-3.03|<0.0001
71083370|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.33||||0.003|TWO_SIDED|90.0|1.09|3.57|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.57|1.09|0.003
70855991|NCT00770146|141198645|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustments were made for tertiary parameters.|t-test, 2 sided|||||||<0.001
70855992|NCT00770146|141198647|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||<0.001
70855993|NCT00770146|141198649|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustments were made for tertiary parameters.|t-test, 2 sided|||||||<0.001
70855994|NCT00770146|141198651|SUPERIORITY_OR_OTHER|||||||0.032||||||No adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.032
71083371|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.87||||0.01|TWO_SIDED|90.0|0.69|3.04|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.04|0.69|0.010
71083372|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.89||||0.205|TWO_SIDED|90.0|-0.27|2.05|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.05|-0.27|0.205
70855995|NCT00816023|141198658|SUPERIORITY_OR_OTHER|||||||0.474||95.0|||||Jonckheere-Terpstra|||||||0.474
70855996|NCT05027971|141198660|OTHER||Proportion by cohort|0.02|||||TWO_SIDED|95.0|0.002|0.07||||||||.07|.002|
70855997|NCT05027971|141198661|OTHER||Proportion by cohort|0.03|||||TWO_SIDED|95.0|0.006|0.084||||||||.084|.006|
70855998|NCT05027971|141198662|OTHER||Proportion by cohort|0.667|||||TWO_SIDED|95.0|0.553|0.768||||||||.768|.553|
70855999|NCT05027971|141198663|OTHER||Mean Difference (Final Values)|-15.8|||||TWO_SIDED|95.0|-17.4|-14.2||||||||-14.2|-17.4|
70856000|NCT05027971|141198666|OTHER||Proportion by cohort|1.0|||||TWO_SIDED|95.0|0.963|1.0||||||||1|.963|
70856001|NCT05027971|141198667|OTHER||Proportion by cohort|1.0|||||TWO_SIDED|95.0|0.963|1.0||||||||1|.963|
70856002|NCT05027971|141198668|OTHER||Proportion by cohort|1.0|||||TWO_SIDED|95.0|0.963|1.0||||||||1|.963|
70856003|NCT05027971|141198669|OTHER||Proportion by cohort|0.889|||||TWO_SIDED|95.0|0.81|0.943||||||||.943|.810|
70856004|NCT05027971|141198670|OTHER||Mean Difference (Final Values)|15.0|||||TWO_SIDED|95.0|11.3|18.6||||||||18.6|11.3|
70856005|NCT05027971|141198671|OTHER||Mean Difference (Final Values)|-3.4|||||TWO_SIDED|95.0|-3.9|-2.9||||||||-2.9|-3.9|
70856006|NCT05027971|141198672|OTHER||Proportion by cohort|1.0|||||TWO_SIDED|95.0|0.963|1.0||||||||1|.963|
70856007|NCT01903252|141198693|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority, pre-defined non-inferiority margin 10% A two-sided 95% confidence interval about the difference in proportions was constructed. If the lower limit of the confidence interval was no less than -10% it would be concluded that the test product is non-inferior to the comparator.|Risk Difference (RD)|-2.2||||0.005|TWO_SIDED|95.0|-8.1|3.8|||Non-inferiority|||If the lower limit of the confidence interval was no less than -10% it would be concluded that the test product is non-inferior to the comparator.||3.8|-8.1|0.005
70856008|NCT01903252|141198694|SUPERIORITY_OR_OTHER||Percentag|75.3|||||TWO_SIDED|95.0|69.4|80.6||||||||80.6|69.4|
70856009|NCT01903252|141198696|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority|Risk Difference (RD)|-2.1|||<|0.001|TWO_SIDED|95.0|-6.5|2.2|||Non-inferiority|||||2.2|-6.5|<0.001
70856010|NCT01903252|141198697|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-3.1||||0.026|TWO_SIDED|95.0|-10.1|3.9|||Non-inferiority|||||3.9|-10.1|0.026
71083373|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.44||||0.045|TWO_SIDED|90.0|0.26|2.63|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.63|0.26|0.045
71083374|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.09||||0.005|TWO_SIDED|90.0|0.88|3.31|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.31|0.88|0.005
71083375|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.51|||<|0.001|TWO_SIDED|90.0|1.33|3.7|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.70|1.33|<0.001
71083376|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.29||||0.002|TWO_SIDED|90.0|1.1|3.48|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.48|1.10|0.002
71083377|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.27||||0.757|TWO_SIDED|90.0|-1.15|1.69|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.69|-1.15|0.757
71083378|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13||||0.878|TWO_SIDED|90.0|-1.54|1.27|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.27|-1.54|0.878
71083379|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.24||||0.78|TWO_SIDED|90.0|-1.64|1.17|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.17|-1.64|0.780
71083380|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.36||||0.67|TWO_SIDED|90.0|-1.04|1.77|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.77|-1.04|0.670
71083381|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.98||||0.021|TWO_SIDED|90.0|0.58|3.38|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.38|0.58|0.021
71083382|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.31||||0.126|TWO_SIDED|90.0|-0.1|2.71|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.71|-0.10|0.126
71083383|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.97||||0.215|TWO_SIDED|90.0|-0.32|2.26|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.26|-0.32|0.215
71083384|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.37||||0.635|TWO_SIDED|90.0|-1.65|0.91|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||0.91|-1.65|0.635
71083385|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06||||0.934|TWO_SIDED|90.0|-1.35|1.22|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.22|-1.35|0.934
71083386|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.56||||0.478|TWO_SIDED|90.0|-0.74|1.87|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.87|-0.74|0.478
71083387|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.57||||0.002|TWO_SIDED|90.0|1.26|3.87|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.87|1.26|0.002
71083388|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.99||||0.013|TWO_SIDED|90.0|0.68|3.3|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.30|0.68|0.013
71083389|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.27||||0.736|TWO_SIDED|90.0|-1.04|1.57|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.57|-1.04|0.736
71083390|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.68||||0.386|TWO_SIDED|90.0|-1.96|0.61|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||0.61|-1.96|0.386
71083391|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05||||0.948|TWO_SIDED|90.0|-1.35|1.24|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.24|-1.35|0.948
71083392|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09||||0.908|TWO_SIDED|90.0|-1.41|1.22|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.22|-1.41|0.908
71083393|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.97||||0.015|TWO_SIDED|90.0|0.65|3.28|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.28|0.65|0.015
71083394|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.6||||0.046|TWO_SIDED|90.0|0.29|2.92|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.92|0.29|0.046
71083395|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.6||||0.042|TWO_SIDED|90.0|0.31|2.89|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.89|0.31|0.042
71083396|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.06||||0.94|TWO_SIDED|90.0|-1.22|1.34|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.34|-1.22|0.940
71083397|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.24||||0.114|TWO_SIDED|90.0|-0.05|2.53|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.53|-0.05|0.114
71083398|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.97||||0.228|TWO_SIDED|90.0|-0.35|2.28|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.28|-0.35|0.228
71083399|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.29||||0.005|TWO_SIDED|90.0|0.98|3.6|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.60|0.98|0.005
71083400|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.48||||0.063|TWO_SIDED|90.0|0.17|2.79|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.79|0.17|0.063
71083401|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.5||||0.562|TWO_SIDED|90.0|-0.92|1.91|||ANCOVA|||Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.91|-0.92|0.562
71083402|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.67||||0.431|TWO_SIDED|90.0|-0.73|2.07|||ANCOVA|||Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.07|-0.73|0.431
70856011|NCT01903252|141198698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-4.8||||0.048|TWO_SIDED|95.0|-10.9|1.4|||Non-inferiority|||||1.4|-10.9|0.048
71083403|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.22||||0.795|TWO_SIDED|90.0|-1.18|1.62|||ANCOVA|||Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.62|-1.18|0.795
71083404|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.83||||0.032|TWO_SIDED|90.0|0.43|3.23|||ANCOVA|||Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.23|0.43|0.032
71083405|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.73||||0.002|TWO_SIDED|90.0|1.34|4.13|||ANCOVA|||Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||4.13|1.34|0.002
70856012|NCT01903252|141198699|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority|Risk Difference (RD)|-3.9||||0.042|TWO_SIDED|95.0|-10.8|3.1|||Non-inferiortiy|||||3.1|-10.8|0.042
70856013|NCT01903252|141198700|NON_INFERIORITY|Non-Inferiority|Risk Difference (RD)|-4.2||||0.048|TWO_SIDED|95.0|-11.0|2.7|||Non-inferiority|||||2.7|-11.0|0.048
70856014|NCT01903252|141198701|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-5.3||||0.068|TWO_SIDED|95.0|-11.5|0.9|||Non-inferiority|||||0.9|-11.5|0.068
70856015|NCT01903252|141198702|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-2.9||||0.021|TWO_SIDED|95.0|-9.8|4.0|||Non-inferiortiy|||||4.0|-9.8|0.021
70856016|NCT01903252|141198703|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-3.4||||0.031|TWO_SIDED|95.0|-10.3|3.7|||Non-inferiortiy|||||3.7|-10.3|0.031
70856017|NCT01903252|141198704|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-3.7||||0.013|TWO_SIDED|95.0|-9.2|1.8|||Non-inferiority|||||1.8|-9.2|0.013
70856018|NCT01903252|141198705|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-3.9||||0.042|TWO_SIDED|95.0|-10.8|3.0|||Non-inferiority|||||3.0|-10.8|0.042
70856019|NCT01903252|141198706|OTHER||Mean Difference (Net)|-0.1||||0.557|TWO_SIDED|95.0|-0.5|0.3|||t-test, 2 sided|||||0.3|-0.5|0.557
70856020|NCT01903252|141198707|OTHER||Mean Difference (Net)|0.0||||0.987|TWO_SIDED|95.0|-0.3|0.3|||t-test, 2 sided|||||0.3|-0.3|0.987
70856021|NCT01903252|141198708|OTHER||Mean Difference (Net)|0.1||||0.455|TWO_SIDED|95.0|-0.1|0.2|||t-test, 2 sided||The result of the mean difference is not corresponding to the values in the table due to rounding as specified in the Statistical Analysis Plan (SAP).|||0.2|-0.1|0.455
70856022|NCT01903252|141198709|OTHER||Mean Difference (Net)|0.0||||0.937|TWO_SIDED|95.0|-0.1|0.1|||t-test, 2 sided||The apparent difference between the values in the table and the mean difference is due to rounding as defined in the SAP.|||0.1|-0.1|0.937
70856023|NCT01903252|141198710|OTHER||Mean Difference (Net)|-0.1||||0.357|TWO_SIDED|95.0|-0.2|0.1|||t-test, 2 sided|||||0.1|-0.2|0.357
70856024|NCT01903252|141198711|OTHER||Mean Difference (Net)|-0.1||||0.099|TWO_SIDED|95.0|-0.2|0.0|||t-test, 2 sided|||||0.0|-0.2|0.099
70856025|NCT01903252|141198712|OTHER||Percentage|21.8|||||TWO_SIDED|95.0|16.8|27.5||||||||27.5|16.8|
70856026|NCT01903252|141198713|OTHER||Percentage|60.1|||||TWO_SIDED|95.0|53.6|66.3||||||||66.3|53.6|
70856027|NCT01903252|141198714|OTHER||Percentage|26.3|||||TWO_SIDED|95.0|20.9|32.3||||||||32.3|20.9|
70856028|NCT01903252|141198715|OTHER||Percentage|44.9|||||TWO_SIDED|95.0|38.5|51.3||||||||51.3|38.5|
71083406|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.04||||0.017|TWO_SIDED|90.0|0.64|3.44|||ANCOVA|||Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.44|0.64|0.017
71083407|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.26||||0.124|TWO_SIDED|90.0|-0.09|2.6|||ANCOVA|||Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.60|-0.09|0.124
71083408|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.08||||0.92|TWO_SIDED|90.0|-1.25|1.41|||ANCOVA|||Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.41|-1.25|0.920
71083409|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12||||0.887|TWO_SIDED|90.0|-1.46|1.22|||ANCOVA|||Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.22|-1.46|0.887
71083410|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.42||||0.083|TWO_SIDED|90.0|0.08|2.77|||ANCOVA|||Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.77|0.08|0.083
71083411|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.65||||0.002|TWO_SIDED|90.0|1.29|4.01|||ANCOVA|||Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||4.01|1.29|0.002
71083412|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.3||||0.006|TWO_SIDED|90.0|0.94|3.66|||ANCOVA|||Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.66|0.94|0.006
71083413|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.49||||0.533|TWO_SIDED|90.0|-0.8|1.78|||ANCOVA|||Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.78|-0.80|0.533
71083414|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.02||||0.985|TWO_SIDED|90.0|-1.29|1.26|||ANCOVA|||Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.26|-1.29|0.985
71083415|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.34||||0.665|TWO_SIDED|90.0|-0.95|1.62|||ANCOVA|||Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.62|-0.95|0.665
71083416|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.86||||0.276|TWO_SIDED|90.0|-0.44|2.15|||ANCOVA|||Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.15|-0.44|0.276
71083417|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.34||||0.004|TWO_SIDED|90.0|1.04|3.65|||ANCOVA|||Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.65|1.04|0.004
71083418|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.04||||0.011|TWO_SIDED|90.0|0.74|3.35|||ANCOVA|||Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.35|0.74|0.011
71083419|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.78||||0.033|TWO_SIDED|90.0|0.41|3.14|||ANCOVA|||Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.14|0.41|0.033
71083420|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.84||||0.302|TWO_SIDED|90.0|-0.5|2.19|||ANCOVA|||Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.19|-0.50|0.302
71083421|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.94||||0.255|TWO_SIDED|90.0|-0.42|2.3|||ANCOVA|||Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.30|-0.42|0.255
71083422|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.08||||0.198|TWO_SIDED|90.0|-0.3|2.46|||ANCOVA|||Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.46|-0.30|0.198
71121954|NCT01719003|141750122|SUPERIORITY_OR_OTHER||Adjusted Mean|-2.26|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-3.09|-1.43||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of body weight after 24 weeks of double-blind treatment.||-1.43|-3.09|<0.0001
70856029|NCT01903252|141198716|OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|1.5||||||||1.5|0.0|
70856030|NCT03467685|141198727|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
71083423|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.68||||0.002|TWO_SIDED|90.0|1.3|4.06|||ANCOVA|||Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||4.06|1.30|0.002
71083424|NCT00572455|141672820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.68||||0.046|TWO_SIDED|90.0|0.3|3.06|||ANCOVA|||Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.06|0.30|0.046
71083425|NCT04152083|141672845|OTHER||Hazard Ratio (HR)|1.54||||0.0006|TWO_SIDED|95.0|1.2|1.98||Threshold for significance at 0.05 level.|Likelihood ratio test|||The median estimate for each treatment group, hazard ratio, and its 95% confidence interval (CI) were based on the stratified Cox model with Efron's method of tie handling. The analysis was censored at the time point of first rescue medication. The stratification factors were concomitant migraine preventive treatment use and region.||1.98|1.20|0.0006
71083426|NCT04152083|141672846|OTHER||Hazard Ratio (HR)|1.75|||<|0.0001|TWO_SIDED|95.0|1.41|2.19||Threshold for significance at 0.05 level.|Likelihood ratio test|||The median estimate for each treatment group, hazard ratio, and its 95% CI were based on the stratified Cox model with Efron's method of tie handling. The analysis was censored at the time point of first rescue medication. The stratification factors were concomitant migraine preventive treatment use and region.||2.19|1.41|<0.0001
71083427|NCT04152083|141672847|OTHER||Odds Ratio (OR)|2.27||||0.0009|TWO_SIDED|95.0|1.39|3.72||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Odds ratio and 95% CI were based on Cochran-Mantel-Haenszel (CMH) test adjusted for the study's stratification factors of concomitant migraine preventive treatment use and region.||3.72|1.39|0.0009
71083428|NCT04152083|141672848|OTHER||Odds Ratio (OR)|2.25|||<|0.0001|TWO_SIDED|95.0|1.55|3.25||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Odds ratio and 95% CI were based on CMH test adjusted for the study's stratification factors of concomitant migraine preventive treatment use and region.||3.25|1.55|<0.0001
70856031|NCT03836001|141198728|SUPERIORITY|||||||0.59||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||||||0.59
71083429|NCT00856999|141672852|EQUIVALENCE|Non-parametric test equivalent to the dependent t-test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<.001
71083430|NCT00856999|141672853|EQUIVALENCE|Non-parametric test equivalent to the dependent t-test|||||<|0.0004|||||||Wilcoxon (Mann-Whitney)|||||||<.0004
71083431|NCT00656175|141672870|SUPERIORITY_OR_OTHER|||||||0.52||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon sign-rank test used for statistical significance.||||0.52
70856032|NCT03836001|141198729|SUPERIORITY|||||||1||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||||||1
71083432|NCT03705286|141672904|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|1.87||0.78|TWO_SIDED|95.0|-4.21|3.17|||Regression, Linear|||We evaluated whether there are differences in the Physical Component Score (PCS) for QOL between the PU-EVAC and PVC treatment groups by comparing their respective mean scores (i.e., mean\[PU-EVAC\] - mean\[PVC\] ). We modeled the data using linear regression and used robust standard error estimates to construct our statistical test and 95% confidence interval estimates. We also estimated the treatment groups' mean quality of life scores with standard error estimates and 95% confidence intervals.||3.17|-4.21|0.78
71083433|NCT03705286|141672904|SUPERIORITY||Mean Difference (Final Values)|-2.98|STANDARD_ERROR_OF_MEAN|2.05||0.15|TWO_SIDED|95.0|-7.03|1.07|||Regression, Linear|||We evaluated whether there are differences in the Mental Component Score (MCS) for QOL between the PU-EVAC and PVC treatment groups by comparing their respective mean scores (i.e., mean\[PU-EVAC\] - mean\[PVC\] ). We modeled the data using linear regression and used robust standard error estimates to construct our statistical test and 95% confidence interval estimates. We also estimated the treatment groups' mean quality of life scores with standard error estimates and 95% confidence intervals.||1.07|-7.03|0.15
71083434|NCT03705286|141672905|SUPERIORITY||Risk Difference (RD)|0.05||||0.05|TWO_SIDED|98.0|-0.07|0.17|||Regression, Logistic|||||0.17|-0.07|0.05
71083435|NCT03705286|141672906|SUPERIORITY||Risk Difference (RD)|0.126||||0.05|TWO_SIDED|95.0|-0.01|0.26|||Regression, Logistic|||We evaluated whether there are differences in the risk of laryngeal injury between the PU-EVAC and PVC treatment groups, comparing their respective risk difference (i.e., probability\[PU-EVAC\] - probability \[PVC\]). We fit a logistic regression model and incorporated robust (i.e., Huber-White heteroskedastic consistent) standard error estimates for our hypothesis test and 95% confidence interval estimates.||0.26|-0.01|0.05
70856033|NCT03836001|141198730|SUPERIORITY|||||||1||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||||||1
70856034|NCT03836001|141198731|SUPERIORITY|||||||0.67||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||||||0.67
70856035|NCT03836001|141198732|SUPERIORITY|||||||1||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||||||1
71083436|NCT01401543|141672907|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric Least Squares (LS) Mean Ratio|0.96|||||TWO_SIDED|90.0|0.91|1.01|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.01|0.91|
71083437|NCT01401543|141672907|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.89|||||TWO_SIDED|90.0|0.85|0.93|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.93|0.85|
71083438|NCT01401543|141672907|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.93|||||TWO_SIDED|90.0|0.88|0.97|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.97|0.88|
71083439|NCT01401543|141672907|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.9|||||TWO_SIDED|90.0|0.86|0.95|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.95|0.86|
71083440|NCT01401543|141672907|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.94|||||TWO_SIDED|90.0|0.9|0.99|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.99|0.90|
71083441|NCT01401543|141672907|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|1.02|||||TWO_SIDED|90.0|0.97|1.07|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.07|0.97|
71083442|NCT01401543|141672908|NON_INFERIORITY_OR_EQUIVALENCE|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.84|||||TWO_SIDED|90.0|0.77|0.91|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.91|0.77|
71083443|NCT01401543|141672908|NON_INFERIORITY_OR_EQUIVALENCE|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.78|||||TWO_SIDED|90.0|0.71|0.85|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.85|0.71|
71083444|NCT01401543|141672908|NON_INFERIORITY_OR_EQUIVALENCE|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.93|||||TWO_SIDED|90.0|0.85|1.01|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.01|0.85|
71083445|NCT01401543|141672908|NON_INFERIORITY_OR_EQUIVALENCE|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.77|||||TWO_SIDED|90.0|0.7|0.84|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.84|0.70|
71083446|NCT01401543|141672908|NON_INFERIORITY_OR_EQUIVALENCE|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.91|||||TWO_SIDED|90.0|0.84|1.0|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.00|0.84|
71083447|NCT01401543|141672908|NON_INFERIORITY_OR_EQUIVALENCE|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.99|||||TWO_SIDED|90.0|0.91|1.08|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.08|0.91|
71083448|NCT01401543|141672909|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.99|||||TWO_SIDED|90.0|0.93|1.05||||||||1.05|0.93|
71083449|NCT01401543|141672909|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.94|||||TWO_SIDED|90.0|0.89|1.0||||||||1.00|0.89|
71083450|NCT01401543|141672909|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.96|||||TWO_SIDED|90.0|0.9|1.02||||||||1.02|0.90|
71083451|NCT01401543|141672909|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.96|||||TWO_SIDED|90.0|0.9|1.02||||||||1.02|0.90|
71083452|NCT01401543|141672909|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.97|||||TWO_SIDED|90.0|0.91|1.03||||||||1.03|0.91|
71083453|NCT01401543|141672909|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|1.01|||||TWO_SIDED|90.0|0.95|1.08||||||||1.08|0.95|
71083454|NCT01401543|141672910|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.72|||||TWO_SIDED|90.0|0.68|0.77|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.77|0.68|
71083455|NCT01401543|141672910|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.71|||||TWO_SIDED|90.0|0.66|0.76|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.76|0.66|
71083456|NCT01401543|141672910|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.98|||||TWO_SIDED|90.0|0.92|1.05|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.05|0.92|
71083457|NCT01401543|141672910|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.69|||||TWO_SIDED|90.0|0.65|0.74|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.74|0.65|
71083458|NCT01401543|141672910|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.96|||||TWO_SIDED|90.0|0.9|1.02|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.02|0.90|
71083459|NCT01401543|141672910|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.98|||||TWO_SIDED|90.0|0.91|1.04|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.04|0.91|
71083460|NCT04776928|141672928|SUPERIORITY|||||||0.01|||||||Two-part regression model|||||||0.010
71083461|NCT00103285|141672931|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.17|||||TWO_SIDED|95.0|1.61|16.63|||Mixed Models Analysis||Odds Ratios in this Statistical Analysis corresponds to all four time points.|Physical Functioning: Parents of 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning) and Family Assessment Device-General Functioning (FAD-GF) at 1, 6 and 12 months after diagnosis, and 3 months post-therapy.||16.63|1.61|
71083462|NCT00103285|141672931|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.99|||||TWO_SIDED|95.0|1.21|3.27|||Mixed Models Analysis||Odds Ratios in this Statistical Analysis corresponds to all four time points|Social Functioning: Parents of 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning) and Family Assessment Device-General Functioning (FAD-GF) at 1, 6 and 12 months after diagnosis, and 3 months post-therapy.||3.27|1.21|
71083463|NCT00103285|141672931|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.85|||||TWO_SIDED|95.0|1.03|3.34|||Mixed Models Analysis||Odds Ratios in this Statistical Analysis corresponds to all four time points|Parents of 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning) and Family Assessment Device-General Functioning (FAD-GF) at 1, 6 and 12 months after diagnosis, and 3 months post-therapy.||3.34|1.03|
70856036|NCT03836001|141198733|OTHER||Mean Difference (Net)|-0.11||||0.09|TWO_SIDED|95.0|-0.24|0.02||A p-value of \<0.05 would be considered statistically significant.|Mixed Models Analysis|||Analysis of change from baseline through week 8 including all time points. For this analysis, data were censored at the time of participant discontinuation.||0.02|-0.24|0.09
70856037|NCT03836001|141198734|SUPERIORITY||Mean Difference (Net)|-0.08||||0.16|TWO_SIDED|95.0|-0.19|0.03||A p-value of \<0.05 would be considered statistically significant.|Mixed Models Analysis|||Analysis of change from baseline through week 8 including all time points. For this analysis, data were censored at the time of participant discontinuation.||0.03|-0.19|0.16
70856038|NCT03836001|141198736|OTHER||Mean Difference (Net)|-0.25||||0.002|TWO_SIDED|95.0|-0.41|-0.09||A p-value of \<0.05 would be considered statistically significant.|Mixed Models Analysis|||Analysis of change from baseline through week 8 including all time points. For this analysis, data were censored at the time of participant discontinuation.||-0.09|-0.41|0.002
70856039|NCT04876690|141198772|SUPERIORITY||||||=|0.1217|||||||t-test for Independent Samples|||PCS-12: Sex||||=0.1217
70856040|NCT04876690|141198772|SUPERIORITY||||||=|0.8241|||||||ANOVA|ANOVA=Analysis of variance||PCS-12: Employment Status||||=0.8241
70856041|NCT04876690|141198772|SUPERIORITY||||||=|0.3471|||||||ANOVA|||PCS-12: Smoking Status||||=0.3471
71121955|NCT01735708|141750124|SUPERIORITY|ITT analysis using multiple imputation by chained equation with 50 fully populated data sets.|Mean Difference (Net)|-1.31|STANDARD_ERROR_OF_MEAN|0.493||0.008|TWO_SIDED|95.0|-2.28|-0.34||A priori threshold for significance was two-tailed p = .05.|Mixed Models Analysis|Standard errors were based on robust Huber-White variance estimator.|standard error of difference in means|||-0.34|-2.28|0.008
70944447|NCT04159805|141389039|SUPERIORITY||Difference in LS Mean|1.01|||=|0.299|TWO_SIDED|95.0|-0.94|2.97||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||2.97|-0.94|=0.299
70944448|NCT04159805|141389039|SUPERIORITY||Difference in LS Mean|-0.11|||=|0.924|TWO_SIDED|95.0|-2.34|2.13||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||2.13|-2.34|=0.924
70944449|NCT04159805|141389039|SUPERIORITY||Difference in LS Mean|1.86|||=|0.091|TWO_SIDED|95.0|-0.32|4.04||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||4.04|-0.32|=0.091
70944450|NCT04159805|141389039|SUPERIORITY||Difference in LS Mean|-0.18|||=|0.887|TWO_SIDED|95.0|-2.82|2.45||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||2.45|-2.82|=0.887
70944451|NCT04159805|141389039|SUPERIORITY||Difference in LS Mean|1.8|||=|0.162|TWO_SIDED|95.0|-0.76|4.36||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||4.36|-0.76|=0.162
70944452|NCT04159805|141389039|SUPERIORITY||Difference in LS Mean|-0.36|||=|0.784|TWO_SIDED|95.0|-3.01|2.29||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||2.29|-3.01|=0.784
70944453|NCT04159805|141389039|SUPERIORITY||Difference in LS Mean|1.79|||=|0.166|TWO_SIDED|95.0|-0.79|4.37||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||4.37|-0.79|=0.166
70944454|NCT04159805|141389039|SUPERIORITY||Difference in LS Mean|0.42|||=|0.724|TWO_SIDED|95.0|-1.98|2.82||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||2.82|-1.98|=0.724
70944455|NCT04159805|141389039|SUPERIORITY||Difference in LS Mean|1.81|||=|0.124|TWO_SIDED|95.0|-0.52|4.14||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||4.14|-0.52|=0.124
70944456|NCT04159805|141389039|SUPERIORITY||Difference in LS Mean|0.29|||=|0.856|TWO_SIDED|95.0|-2.91|3.48||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||3.48|-2.91|=0.856
70944457|NCT04159805|141389039|SUPERIORITY||Difference in LS Mean|1.64|||=|0.292|TWO_SIDED|95.0|-1.48|4.76||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||4.76|-1.48|=0.292
70944458|NCT04159805|141389039|SUPERIORITY||Difference in LS Mean|0.11|||=|0.944|TWO_SIDED|95.0|-3.14|3.37||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||3.37|-3.14|=0.944
70944459|NCT04159805|141389039|SUPERIORITY||Difference in LS Mean|0.85|||=|0.589|TWO_SIDED|95.0|-2.33|4.02||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||4.02|-2.33|=0.589
70856042|NCT04876690|141198772|SUPERIORITY||||||=|0.9951|||||||ANOVA|||PCS-12: Age at Onset||||=0.9951
70856043|NCT04876690|141198772|SUPERIORITY||||||=|0.0631|||||||ANOVA|||PCS-12: Disease Location||||=0.0631
70944460|NCT04159805|141389040|SUPERIORITY||Difference in LS Mean|-0.93|||=|0.406|TWO_SIDED|95.0|-3.17|1.31||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||1.31|-3.17|=0.406
70944461|NCT04159805|141389040|SUPERIORITY||Difference in LS Mean|0.9|||=|0.418|TWO_SIDED|95.0|-1.34|3.14||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||3.14|-1.34|=0.418
70944462|NCT04159805|141389040|SUPERIORITY||Difference in LS Mean|-0.94|||=|0.463|TWO_SIDED|95.0|-3.53|1.65||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||1.65|-3.53|=0.463
71121956|NCT01735708|141750125|SUPERIORITY|Intent to treat analysis using multiple imputation by chained equations with 50 fully populated data sets.|Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|0.495||0.251|TWO_SIDED|95.0|-1.53|0.4||A priori threshold for significance was two-tailed p = .05.|Mixed Models Analysis|Standard errors were based on robust Huber-White variance estimator.||||0.40|-1.53|0.251
70856044|NCT04876690|141198772|SUPERIORITY||||||=|0.7473|||||||ANOVA|||PCS-12: Disease Behavior||||=0.7473
70856045|NCT04876690|141198772|SUPERIORITY||||||=|0.4422|||||||t-test for Independent Samples|||PCS-12: Presence of any Extraintestinal Manifestation of CD||||=0.4422
70856046|NCT04876690|141198772|SUPERIORITY||||||=|0.1796|||||||t-test for Independent Samples|||PCS-12: Fistula With High Intersphincteric Type||||=0.1796
70856047|NCT04876690|141198772|SUPERIORITY||||||=|0.3535|||||||t-test for Independent Samples|||PCS-12: Fistula With High Transsphincteric Type||||=0.3535
70856048|NCT04876690|141198772|SUPERIORITY||||||=|0.1508|||||||t-test for Independent Samples|||PCS-12: Fistula With Suprasphincteric Type||||=0.1508
70856049|NCT04876690|141198772|SUPERIORITY||||||=|0.2671|||||||t-test for Independent Samples|||PCS-12: Fistula with Extrasphincteric Type||||=0.2671
70856050|NCT04876690|141198772|SUPERIORITY||||||=|0.0594|||||||t-test for Independent Samples|||PCS-12: Fistula With Low Intersphincteric Type||||=0.0594
70856051|NCT04876690|141198772|SUPERIORITY||||||=|0.5484|||||||t-test for Independent Samples|||PCS-12: Fistula With Low Transsphincteric Type||||=0.5484
70856052|NCT04876690|141198772|SUPERIORITY||||||=|0.5387|||||||t-test for Independent Samples|||PCS-12: Fistula With Midline Position||||=0.5387
70856053|NCT04876690|141198772|SUPERIORITY||||||=|0.527|||||||t-test for Independent Samples|||PCS-12: Fistula With Lateral Position||||=0.5270
70856054|NCT04876690|141198772|SUPERIORITY||||||=|0.3863|||||||t-test for Independent Samples|||PCS-12: Fistula With Seton||||=0.3863
70856055|NCT04876690|141198772|SUPERIORITY||||||=|0.4206|||||||ANOVA|||PCS-12: HBI Categories (Remission, Mild and Moderate Activity)||||=0.4206
70856056|NCT04876690|141198772|SUPERIORITY||||||=|0.0538|||||||t-test for Independent Samples|||PCS-12: Surgery-naïve||||=0.0538
70856057|NCT04876690|141198772|SUPERIORITY||||||=|0.9572|||||||t-test for Independent Samples|||PCS-12: Surgery - Fistulotomy||||=0.9572
70944463|NCT04159805|141389040|SUPERIORITY||Difference in LS Mean|-0.1|||=|0.936|TWO_SIDED|95.0|-2.7|2.49||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||2.49|-2.70|=0.936
71121957|NCT01735708|141750126|SUPERIORITY|Intent to treat analysis using multiple imputation by chained equations with 50 fully populated data sets.|Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.75||0.844|TWO_SIDED|95.0|-1.32|1.61||A priori threshold for significance was two-tailed p = .05.|Mixed Models Analysis|Standard errors were based on robust Huber-White variance estimator.|Standard error of difference in means.|||1.61|-1.32|0.844
71121958|NCT01735708|141750127|SUPERIORITY|Intent to treat analysis using multiple imputation by chained equations with 50 fully populated data sets.|Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.836||0.545|TWO_SIDED|95.0|-2.18|1.15||A priori threshold for significance was two-tailed p = .05.|Mixed Models Analysis|Standard errors were based on robust Huber-White variance estimator.|Standard error of difference in means.|||1.15|-2.18|0.545
71121959|NCT04883528|141750128|SUPERIORITY|||||||0.29|||||||Mixed Models Analysis|||||||0.29
71121960|NCT04883528|141750129|SUPERIORITY|||||||0.88|||||||Mixed Models Analysis|||||||0.88
71121961|NCT04883528|141750130|SUPERIORITY|||||||0.76|||||||Mixed Models Analysis|||||||0.76
71121962|NCT04883528|141750131|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||||||0.85
71121963|NCT04883528|141750132|SUPERIORITY|||||||0.8|||||||Mixed Models Analysis|||||||0.80
71121964|NCT04883528|141750133|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
71121965|NCT04883528|141750134|SUPERIORITY|||||||0.23|||||||Mixed Models Analysis|||||||0.23
71121966|NCT04883528|141750135|SUPERIORITY|||||||0.95|||||||Mixed Models Analysis|||||||0.95
71121967|NCT04883528|141750136|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
71121968|NCT04883528|141750140|SUPERIORITY||Least squares mean difference|-0.01||||0.64|TWO_SIDED|95.0|-0.07|0.04|||Mixed Models Analysis|||||0.04|-0.07|0.64
71121969|NCT04883528|141750141|SUPERIORITY||Least squares mean difference|-7.55||||0.04|TWO_SIDED|95.0|-14.59|0.52|||Mixed Models Analysis|||||0.52|-14.59|0.04
71121970|NCT00394901|141750149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31||||0.262||95.0|-0.85|0.23|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.23|-0.85|0.262
71121971|NCT00394901|141750149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.86||||0.002||95.0|-1.39|-0.32|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.32|-1.39|0.002
71121972|NCT00394901|141750149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63||||0.019||95.0|-1.15|-0.1|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.10|-1.15|0.019
71121973|NCT00394901|141750150|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64||||0.016||95.0|-1.16|-0.12|||ANCOVA|The model included treatment group modified based on the expected pregabalin exposure as a factor, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.12|-1.16|0.016
71121974|NCT00394901|141750150|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66||||0.008||95.0|-1.14|-0.17|||ANCOVA|The model included treatment group modified based on the expected pregabalin exposure as a factor, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.17|-1.14|0.008
71121975|NCT00394901|141750151|SUPERIORITY_OR_OTHER_LEGACY|||||||0.116||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Proportion of responders were used for the statistical analyses. Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.1160
71121976|NCT00394901|141750151|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0015||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Proportion of responders were used for the statistical analyses. Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0015
71121977|NCT00394901|141750151|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0107||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Proportion of responders were used for the statistical analyses. Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0107
71121978|NCT00394901|141750152|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51||||0.038||95.0|-0.99|-0.03|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.03|-0.99|0.038
71121979|NCT00394901|141750152|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75||||0.002||95.0|-1.22|-0.27|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.27|-1.22|0.002
71121980|NCT00394901|141750152|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.72||||0.002||95.0|-1.19|-0.26|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.26|-1.19|0.002
71121981|NCT00394901|141750153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48||||0.048||95.0|-0.97|0.0|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.00|-0.97|0.048
71121982|NCT00394901|141750153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.99|||<|0.001||95.0|-1.47|-0.52|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.52|-1.47|<0.001
71121983|NCT00394901|141750153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.03|||<|0.001||95.0|-1.49|-0.56|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.56|-1.49|<0.001
71121984|NCT00394901|141750154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41||||0.096||95.0|-0.89|0.07|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.07|-0.89|0.096
71121985|NCT00394901|141750154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.96|||<|0.001||95.0|-1.44|-0.48|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.48|-1.44|<0.001
71121986|NCT00394901|141750154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.99|||<|0.001||95.0|-1.46|-0.52|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.52|-1.46|<0.001
71121987|NCT00394901|141750155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55||||0.505||95.0|-2.16|1.06|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||1.06|-2.16|0.505
71121988|NCT00394901|141750155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.86||||0.023||95.0|-3.46|-0.26|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.26|-3.46|0.023
71121989|NCT00394901|141750155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.012||95.0|-3.56|-0.44|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.44|-3.56|0.012
71121990|NCT00394901|141750156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29||||0.349||95.0|-0.91|0.32|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.32|-0.91|0.349
71121991|NCT00394901|141750156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.71||||0.024||95.0|-1.32|-0.1|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.10|-1.32|0.024
71121992|NCT00394901|141750156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.61||||0.045||95.0|-1.21|-0.01|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.01|-1.21|0.045
71121993|NCT00394901|141750157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.83||||0.441||95.0|-2.93|1.28|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||1.28|-2.93|0.441
71121994|NCT00394901|141750157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.55||||0.017||95.0|-4.64|-0.46|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.46|-4.64|0.017
71121995|NCT00394901|141750157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.61||||0.012||95.0|-4.65|-0.56|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.56|-4.65|0.012
71121996|NCT00394901|141750158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.23||||0.47||95.0|-8.28|3.83|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.83|-8.28|0.470
71121997|NCT00394901|141750158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.04||||0.008||95.0|-14.0|-2.06|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-2.06|-14.0|0.008
70944464|NCT04159805|141389040|SUPERIORITY||Difference in LS Mean|-1.8|||=|0.17|TWO_SIDED|95.0|-4.41|0.82||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||0.82|-4.41|=0.170
71121998|NCT00394901|141750158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.43||||0.013||95.0|-13.3|-1.59|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-1.59|-13.3|0.013
71121999|NCT00394901|141750159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.178||95.0|-0.48|0.09|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.09|-0.48|0.178
71122000|NCT00394901|141750159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43||||0.003||95.0|-0.72|-0.15|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.15|-0.72|0.003
70856058|NCT04876690|141198772|SUPERIORITY||||||=|0.4742|||||||t-test for Independent Samples|||PCS-12: Surgery - Loose Seton||||=0.4742
70856059|NCT04876690|141198772|SUPERIORITY||||||=|0.5735|||||||t-test for Independent Samples|||PCS-12: Surgery - Other||||=0.5735
70856060|NCT04876690|141198772|SUPERIORITY||||||=|0.376|||||||t-test for Independent Samples|||PCS-12: Presence of Perianal Abscess||||=0.3760
71122001|NCT00394901|141750159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31||||0.03||95.0|-0.59|-0.03|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.03|-0.59|0.030
71122002|NCT00394901|141750160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.76||||0.001||95.0|-1.23|-0.3|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.30|-1.23|0.001
71122003|NCT00394901|141750160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81||||0.001||95.0|-1.27|-0.34|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.34|-1.27|0.001
71122004|NCT00394901|141750160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.94|||<|0.001||95.0|-1.4|-0.49|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.49|-1.40|<0.001
71122005|NCT00394901|141750161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.9||||0.001||95.0|-14.2|-3.61|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-3.61|-14.2|0.001
71122006|NCT00394901|141750161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.24||||0.002||95.0|-13.5|-2.99|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-2.99|-13.5|0.002
71122007|NCT00394901|141750161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.3|||<|0.001||95.0|-16.5|-6.22|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-6.22|-16.5|<0.001
71122008|NCT00394901|141750162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.29||||0.245||95.0|-2.95|11.54|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||11.54|-2.95|0.245
71122009|NCT00394901|141750162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.95||||0.417||95.0|-4.2|10.11|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||10.11|-4.20|0.417
71122010|NCT00394901|141750162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.7||||0.007||95.0|2.67|16.74|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||16.74|2.67|0.007
71122011|NCT00394901|141750163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.71||||0.76||95.0|-3.83|5.24|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.24|-3.83|0.760
71122012|NCT00394901|141750163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.71||||0.754||95.0|-3.75|5.18|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.18|-3.75|0.754
71122013|NCT00394901|141750163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.04||||0.641||95.0|-5.43|3.35|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.35|-5.43|0.641
71122014|NCT00394901|141750164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01||||0.955||95.0|-0.3|0.32|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.32|-0.30|0.955
71122015|NCT00394901|141750164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.27||||0.084||95.0|-0.04|0.58|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.58|-0.04|0.084
71122016|NCT00394901|141750164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21||||0.17||95.0|-0.09|0.52|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.52|-0.09|0.170
71122017|NCT00394901|141750165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.01||||0.296||95.0|-3.52|11.55|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||11.55|-3.52|0.296
71122018|NCT00394901|141750165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.3||||0.007||95.0|2.87|17.73|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||17.73|2.87|0.007
71122019|NCT00394901|141750165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.0||||0.106||95.0|-1.29|13.3|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||13.30|-1.29|0.106
71122020|NCT00394901|141750166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.93||||0.191||95.0|-1.97|9.83|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||9.83|-1.97|0.191
71122021|NCT00394901|141750166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.21|||<|0.001||95.0|5.41|17.02|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||17.02|5.41|<0.001
70856061|NCT04876690|141198773|SUPERIORITY||||||=|0.4814|||||||t-test for Independent Samples|||MCS-12: Sex||||=0.4814
70856062|NCT04876690|141198773|SUPERIORITY||||||=|0.3136|||||||Kruskal-Wallis|||MCS-12: Employment Status||||=0.3136
70856063|NCT04876690|141198773|SUPERIORITY||||||=|0.5808|||||||ANOVA|||MCS-12: Smoking Status||||=0.5808
70856064|NCT04876690|141198773|SUPERIORITY||||||=|0.2965|||||||ANOVA|||MCS-12: Age at Onset||||=0.2965
70856065|NCT04876690|141198773|SUPERIORITY||||||=|0.2874|||||||ANOVA|||MCS-12: Disease Location||||=0.2874
70856066|NCT04876690|141198773|SUPERIORITY||||||=|0.4269|||||||ANOVA|||MCS-12: Disease Behavior||||=0.4269
70856067|NCT04876690|141198773|SUPERIORITY||||||=|0.8931|||||||t-test for Independent Samples|||MCS-12: Presence of any Extraintestinal Manifestation of CD||||=0.8931
70856068|NCT04876690|141198773|SUPERIORITY||||||=|0.9384|||||||t-test for Independent Samples|||MCS-12: Fistula With High Intersphincteric Type||||=0.9384
70856069|NCT04876690|141198773|SUPERIORITY||||||=|0.8286|||||||Mann-Whitney|||MCS-12: Fistula With High Transsphincteric Type||||=0.8286
70856070|NCT04876690|141198773|SUPERIORITY||||||=|0.1919|||||||t-test for Independent Samples|||MCS-12: Fistula With Suprasphincteric Type||||=0.1919
70856071|NCT04876690|141198773|SUPERIORITY||||||=|0.6452|||||||t-test for Independent Samples|||MCS-12: Fistula with Extrasphincteric Type||||=0.6452
70856072|NCT04876690|141198773|SUPERIORITY||||||=|0.7218|||||||t-test for Independent Samples|||MCS-12: Fistula With Low Intersphincteric Type||||=0.7218
70856073|NCT04876690|141198773|SUPERIORITY||||||=|0.9738|||||||t-test for Independent Samples|||MCS-12: Fistula With Low Transsphincteric Type||||=0.9738
71083464|NCT00103285|141672932|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.542|||||TWO_SIDED|95.0|1.974|3.273|||Regression, Cox|||4981 eligible evaluable patients enrolled on AALL0331 had MRD evaluation at Day 29 of induction. MRD status defined as negative (\<0.1%) or positive (\>=0.1%). MRD status ( positive vs. negative) was correlated with EFS using Cox regression analysis.||3.273|1.974|
71083465|NCT00103285|141672934|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.131|||||TWO_SIDED|95.0|0.101|0.17|||Chi-squared|||MRD status ( positive vs. negative) was correlated with Early Marrow Status (M1 vs M2/M3) using Chi Square test.||0.17|0.101|
71122022|NCT00394901|141750166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.23|||<|0.001||95.0|8.5|19.95|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||19.95|8.50|<0.001
71122023|NCT00394901|141750167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.03||||0.061||95.0|-8.25|0.18|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.18|-8.25|0.061
71122024|NCT00394901|141750167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2||||0.133||95.0|-7.37|0.98|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.98|-7.37|0.133
71122025|NCT00394901|141750167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.44||||0.24||95.0|-6.52|1.64|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||1.64|-6.52|0.240
71122026|NCT00394901|141750168|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.68||||0.2842||95.0|0.34|1.37|||Regression, Logistic|treatment, CLcr stratum, and the optimal sleep score at baseline as covariate||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||1.37|0.34|0.2842
71122027|NCT00394901|141750168|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.89||||0.0577||95.0|0.98|3.66|||Regression, Logistic|treatment, CLcr stratum, and the optimal sleep score at baseline as covariate||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.66|0.98|0.0577
70856074|NCT04876690|141198773|SUPERIORITY||||||=|0.2419|||||||t-test for Independent Samples|||MCS-12: Fistula With Midline Position||||=0.2419
70856075|NCT04876690|141198773|SUPERIORITY||||||=|0.5524|||||||t-test for Independent Samples|||MCS-12: Fistula With Lateral Position||||=0.5524
70856076|NCT04876690|141198773|SUPERIORITY||||||=|0.4443|||||||t-test for Independent Samples|||MCS-12: Fistula With Seton||||=0.4443
70856077|NCT04876690|141198773|SUPERIORITY||||||=|0.4106|||||||ANOVA|||MCS-12: HBI Categories (Remission, Mild and Moderate Activity)||||=0.4106
70856078|NCT04876690|141198773|SUPERIORITY||||||=|0.7795|||||||t-test for Independent Samples|||MCS-12: Surgery-naïve||||=0.7795
70856079|NCT04876690|141198773|SUPERIORITY||||||=|0.2964|||||||t-test for Independent Samples|||MCS-12: Surgery - Fistulotomy||||=0.2964
70856080|NCT04876690|141198773|SUPERIORITY||||||=|0.3287|||||||t-test for Independent Samples|||MCS-12: Surgery - Loose Seton||||=0.3287
70856081|NCT04876690|141198773|SUPERIORITY||||||=|0.0091|||||||t-test for Independent Samples|||MCS-12: Surgery - Other||||=0.0091
70856082|NCT04876690|141198773|SUPERIORITY||||||=|0.3889|||||||t-test for Independent Samples|||MCS-12: Presence of Perianal Abscess||||=0.3889
70856083|NCT04876690|141198774|SUPERIORITY||||||=|0.8001|||||||Pearson Correlation Coefficient|||PCS- 12: Age||||=0.8001
70856084|NCT04876690|141198774|SUPERIORITY||||||=|0.4532|||||||Pearson Correlation Coefficient|||PCS- 12: BMI||||=0.4532
70856085|NCT04876690|141198774|SUPERIORITY||||||=|0.9597|||||||Spearman Correlation Coefficient|||PCS- 12: Time Between CD Diagnosis Date and Date of Study Visit||||=0.9597
70856086|NCT04876690|141198774|SUPERIORITY||||||=|0.3304|||||||Spearman Correlation Coefficient|||PCS- 12: Total Number of CPFs per Participant||||=0.3304
70856087|NCT04876690|141198774|SUPERIORITY||||||=|0.6333|||||||Pearson Correlation Coefficient|||PCS- 12: Time Since Seton Replacement||||=0.6333
70856088|NCT04876690|141198774|SUPERIORITY||||||=|0.8003|||||||Spearman Correlation Coefficient|||PCS- 12: Time Between First CPF Diagnosis Date and Date of Study Visit||||=0.8003
70856089|NCT04876690|141198774|SUPERIORITY||||||=|0.0032|||||||Pearson Correlation Coefficient|||PCS- 12: PDAI Score||||=0.0032
70856090|NCT04876690|141198774|SUPERIORITY||||||=|0.0923|||||||Spearman Correlation Coefficient|||PCS- 12: Number of Internal Fistula Openings per Participant||||=0.0923
71083466|NCT00103285|141672935|OTHER||Odds Ratio (OR)|4.1|||||TWO_SIDED|95.0|1.31|12.73|||Regression, Logistic|||Parents of 159 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the BASC-2 Anxiety Scale at 1 month after diagnosis, and 3 months post-therapy. Of these 159 had data at 1 month after diagnosis and 96 at 3 months post therapy.||12.73|1.31|
71083467|NCT03569098|141672976|SUPERIORITY||Difference in LS mean|0.32|STANDARD_ERROR_OF_MEAN|0.441||0.7669|TWO_SIDED|95.0|-0.55|1.19||One-sided P-value. The model includes the fixed categorical effects of treatment group, visit, treatment group-by-visit interaction, and the stratification factor as fixed categorical covariates and the Baseline value as a fixed continuous covariate.|Mixed Model for Repeated Measures (MMRM)|||Dysport 300 U versus Placebo.||1.19|-0.55|0.7669
71083468|NCT03569098|141672976|SUPERIORITY||Difference in LS mean|-0.36|STANDARD_ERROR_OF_MEAN|0.444||0.2085|TWO_SIDED|95.0|-1.24|0.51||One-sided P-value. The model includes the fixed categorical effects of treatment group, visit, treatment group-by-visit interaction, and the stratification factor as fixed categorical covariates and the Baseline value as a fixed continuous covariate.|MMRM|||Dysport 500 U versus Placebo.||0.51|-1.24|0.2085
71083469|NCT00522548|141672999|SUPERIORITY|||||||0.29||||||A p value of less than 0.05 was considered statistically significant.|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||.29
71083470|NCT00522548|141673000|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED|95.0||||A p value of less than 0.05 was considered statistically significant.|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.39
71083471|NCT00522548|141673001|SUPERIORITY|||||||1||||||A p value of less than 0.05 was considered statistically significant.|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||1.0
71083472|NCT00522548|141673002|SUPERIORITY|||||||1||||||A p value of less than 0.05 was considered significant.|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||1.00
71083473|NCT00522548|141673003|SUPERIORITY|||||||0.14||||||a p value of less than 0.05 was considered statistically significant|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.14
71083474|NCT00522548|141673004|SUPERIORITY|||||||0.34||||||A p value of less than 0.05 was considered statistically significant.|Chi-squared|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.34
71083475|NCT00522548|141673005|SUPERIORITY_OR_OTHER|||||||0.51||||||A p-value of less than 0.05 was considered statistically significant.|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||.51
71083476|NCT00522548|141673006|SUPERIORITY|||||||0.95|TWO_SIDED|95.0||||A p-value of less than 0.05 was considered statistically significant.|t-test, 2 sided|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study.||||0.95
71122028|NCT00394901|141750168|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.54||||0.1893||95.0|0.81|2.95|||Regression, Logistic|treatment, CLcr stratum, and the optimal sleep score at baseline as covariate||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||2.95|0.81|0.1893
71122029|NCT00394901|141750169|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0466||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0466
71122030|NCT00394901|141750169|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||<0.001
71122031|NCT00394901|141750169|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||<0.001
71122032|NCT00394901|141750170|SUPERIORITY_OR_OTHER_LEGACY|||||||0.344||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.3440
71122033|NCT00394901|141750170|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||<0.001
70856091|NCT04876690|141198774|SUPERIORITY||||||=|0.0994|||||||Spearman Correlation Coefficient|||PCS- 12: Number of External Fistula Openings per Participant||||=0.0994
71083477|NCT00522548|141673007|SUPERIORITY|||||||0.57||||||The p value was not adjusted for multiple comparisons. A p-value of less than 0.05 was considered statistically significant.|t-test, 2 sided|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study.||||0.57
71083478|NCT00522548|141673008|SUPERIORITY|||||||0.45|TWO_SIDED|95.0||||This represents p value for week 4 data. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.45
71083479|NCT00522548|141673008|SUPERIORITY|||||||0.58|TWO_SIDED|95.0||||This represents p value for week 24 data. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||Sample size was arbitrarily determined as 40 patients (20 in CellCept group and 20 in the Myfortic group) in this proof of concept study.||||0.58
71083480|NCT00522548|141673009|SUPERIORITY|||||||0.012||||||This p value is for data at week 4. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.012
71122034|NCT00394901|141750170|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||<0.001
71122035|NCT00394901|141750171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.51||||0.057||95.0|-0.1|7.13|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||7.13|-0.10|0.057
70856092|NCT04876690|141198774|SUPERIORITY||||||=|0.0444|||||||Pearson Correlation Coefficient|||PCS- 12: SIBDQ Score||||=0.0444
70856093|NCT04876690|141198774|SUPERIORITY||||||=|0.086|||||||Pearson Correlation Coefficient|||PCS- 12: SQoL-M Score||||=0.0860
71122036|NCT00394901|141750171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.77||||0.67||95.0|-2.78|4.32|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||4.32|-2.78|0.670
71083481|NCT00522548|141673009|SUPERIORITY|||||||0.046|TWO_SIDED|95.0||||This p value was for data at week 24. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic Group) in this proof of concept study.||||0.046
71083482|NCT00522548|141673010|SUPERIORITY|||||||0.27||||||p value represents data for week 4. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.27
71083483|NCT00522548|141673010|SUPERIORITY|||||||0.23|TWO_SIDED|95.0||||p value represents data for week 24. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.23
71083484|NCT02121795|141673011|NON_INFERIORITY|Noninferiority was assessed using a conventional 95.002% confidence interval (CI) approach, with a noninferiority margin of 10%.|Percentage difference|1.3||||0.5|TWO_SIDED|95.002|-2.5|5.1|||Cochran-Mantel-Haenszel|P-value was from Cochran-Mantel-Haenszel (CMH) test stratified by third agent.|Difference in percentages of virologic success between treatment groups and its 95.002% CI were calculated based on the Mantel-Haenszel (MH) proportions adjusted by the third agent stratum.|||5.1|-2.5|0.5
71083485|NCT02683239|141673041|SUPERIORITY||Least Squares Mean|-0.73|STANDARD_ERROR_OF_MEAN|0.221|=|0.001|TWO_SIDED|95.0|-1.159|-0.293|||Mixed Models Analysis|||||-0.293|-1.159|= 0.0010
71083486|NCT02683239|141673041|SUPERIORITY||Least Squares Mean|-1.22|STANDARD_ERROR_OF_MEAN|0.217|<|0.0001|TWO_SIDED|95.0|-1.646|-0.793|||Mixed Models Analysis|||||-0.793|-1.646|< 0.0001
71083487|NCT02683239|141673041|SUPERIORITY||Least Squares Mean|-1.23|STANDARD_ERROR_OF_MEAN|0.222|<|0.0001|TWO_SIDED|95.0|-1.664|-0.793|||Mixed Models Analysis|||||-0.793|-1.664|< 0.0001
71083488|NCT02683239|141673041|SUPERIORITY||Least Squares Mean|-1.04|STANDARD_ERROR_OF_MEAN|0.222|<|0.0001|TWO_SIDED|95.0|-1.477|-0.606|||Mixed Models Analysis|||||-0.606|-1.477|< 0.0001
71083489|NCT02683239|141673042|SUPERIORITY||Least Squares Mean|-0.74|STANDARD_ERROR_OF_MEAN|0.218|=|0.0007|TWO_SIDED|95.0|-1.163|-0.309|||Mixed Models Analysis|||||-0.309|-1.163|= 0.0007
71083490|NCT02683239|141673042|SUPERIORITY||Least Squares Mean|-1.2|STANDARD_ERROR_OF_MEAN|0.218|<|0.0001|TWO_SIDED|95.0|-1.624|-0.768|||Mixed Models Analysis|||||-0.768|-1.624|< 0.0001
71083491|NCT02683239|141673042|SUPERIORITY||Least Squares Mean|-1.26|STANDARD_ERROR_OF_MEAN|0.223|<|0.0001|TWO_SIDED|95.0|-1.698|-0.822|||Mixed Models Analysis|||||-0.822|-1.698|< 0.0001
70856094|NCT04876690|141198774|SUPERIORITY||||||=|0.9415|||||||Pearson Correlation Coefficient|||PCS- 12: SQoL-F Score||||=0.9415
71083492|NCT02683239|141673042|SUPERIORITY||Least Squares Mean|-1.13|STANDARD_ERROR_OF_MEAN|0.222|<|0.0001|TWO_SIDED|95.0|-1.564|-0.695|||Mixed Models Analysis|||||-0.695|-1.564|< 0.0001
71083493|NCT02683239|141673043|SUPERIORITY||Least Squares Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.09|=|0.023|TWO_SIDED|95.0|-0.38|-0.028|||Mixed Models Analysis|||||-0.028|-0.380|= 0.0230
71083494|NCT02683239|141673043|SUPERIORITY||Least Squares Mean|-0.27|STANDARD_ERROR_OF_MEAN|0.088|=|0.0025|TWO_SIDED|95.0|-0.437|-0.093|||Mixed Models Analysis|||||-0.093|-0.437|= 0.0025
71083495|NCT02683239|141673043|SUPERIORITY||Least Squares Mean|-0.32|STANDARD_ERROR_OF_MEAN|0.09|=|0.0003|TWO_SIDED|95.0|-0.496|-0.145|||Mixed Models Analysis|||||-0.145|-0.496|= 0.0003
71083496|NCT02683239|141673043|SUPERIORITY||Least Squares Mean|-0.29|STANDARD_ERROR_OF_MEAN|0.089|=|0.001|TWO_SIDED|95.0|-0.466|-0.118|||Mixed Models Analysis|||||-0.118|-0.466|= 0.0010
71083497|NCT02363387|141673045|SUPERIORITY||Odds Ratio (OR)|7.1|||<|0.001|TWO_SIDED|95.0|2.7|18.8|||Regression, Logistic|||||18.8|2.7|<0.001
71083498|NCT02609386|141673052|OTHER||Cox Proportional Hazard|1.102||||0.6176|TWO_SIDED|95.0|0.6|2.1|||Log Rank|||||2.1|0.6|0.6176
71083499|NCT02609386|141673053|OTHER||Cox Proportional Hazard|1.009||||0.3889|TWO_SIDED|95.0|0.5|2.2|||Log Rank|||||2.2|0.5|0.3889
71083500|NCT02609386|141673054|OTHER||Cox Proportional Hazard|1.009||||0.5091|TWO_SIDED|95.0|0.5|2.2|||Log Rank|||||2.2|0.5|0.5091
71083501|NCT00873730|141673059|SUPERIORITY_OR_OTHER|||||||0.6031|||||||Chi-squared|||||||0.6031
71083502|NCT00873730|141673060|SUPERIORITY_OR_OTHER|||||||0.9166|||||||Chi-squared|||||||0.9166
71083503|NCT00873730|141673061|SUPERIORITY_OR_OTHER|||||||0.7564|||||||Chi-squared|||||||0.7564
71083504|NCT00873730|141673062|SUPERIORITY_OR_OTHER|||||||0.3266|||||||Chi-squared|||||||0.3266
71083505|NCT00873730|141673063|SUPERIORITY_OR_OTHER|||||||0.7481|||||||Chi-squared|||||||0.7481
71083506|NCT00873730|141673064|SUPERIORITY_OR_OTHER|||||||0.7721|||||||Chi-squared|||||||0.7721
71083507|NCT00873730|141673065|SUPERIORITY_OR_OTHER|||||||0.666|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Nocturnal Back Pain.||||0.6660
71083508|NCT00873730|141673065|SUPERIORITY_OR_OTHER|||||||0.5364|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Overall Spinal Pain.||||0.5364
71083509|NCT00873730|141673066|SUPERIORITY_OR_OTHER|||||||0.9426|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for the Physician Global Assessment.||||0.9426
71083510|NCT00873730|141673066|SUPERIORITY_OR_OTHER|||||||0.4969|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for the Patient Global Assessment.||||0.4969
71083511|NCT00873730|141673067|SUPERIORITY_OR_OTHER|||||||0.6687|||||||Wilcoxon (Mann-Whitney)|||||||0.6687
71083512|NCT00873730|141673068|SUPERIORITY_OR_OTHER|||||||0.6739|||||||Wilcoxon (Mann-Whitney)|||||||0.6739
71083513|NCT00873730|141673069|SUPERIORITY_OR_OTHER|||||||0.2772|||||||Wilcoxon (Mann-Whitney)|||||||0.2772
71083514|NCT00873730|141673070|SUPERIORITY_OR_OTHER|||||||0.156|||||||Wilcoxon (Mann-Whitney)|||||||0.1560
71083515|NCT00873730|141673071|SUPERIORITY_OR_OTHER|||||||0.2099|||||||Chi-squared|||Analysis provided for Mobility.||||0.2099
70856095|NCT04876690|141198774|SUPERIORITY||||||=|0.3709|||||||Pearson Correlation Coefficient|||PCS- 12: Wexner Score||||=0.3709
70856096|NCT04876690|141198775|SUPERIORITY||||||=|0.0674|||||||Pearson Correlation Coefficient|||MCS- 12: Age||||=0.0674
71083516|NCT00873730|141673071|SUPERIORITY_OR_OTHER|||||||0.8009|||||||Chi-squared|||Analysis provided for Self-care.||||0.8009
71083517|NCT00873730|141673071|SUPERIORITY_OR_OTHER|||||||0.429|||||||Chi-squared|||Analysis provided for Usual activities.||||0.4290
71083518|NCT00873730|141673071|SUPERIORITY_OR_OTHER|||||||0.0461|||||||Chi-squared|||Analysis provided for Pain/Discomfort.||||0.0461
71083519|NCT00873730|141673071|SUPERIORITY_OR_OTHER|||||||0.562|||||||Chi-squared|||Analysis provided for Anxiety/Depression.||||0.5620
70856097|NCT04876690|141198775|SUPERIORITY||||||=|0.9392|||||||Pearson Correlation Coefficient|||MCS- 12: BMI||||=0.9392
70856098|NCT04876690|141198775|SUPERIORITY||||||=|0.6387|||||||Spearman Correlation Coefficient|||MCS- 12: Time Between CD Diagnosis Date and Date of Study Visit||||=0.6387
70856099|NCT04876690|141198775|SUPERIORITY||||||=|0.7846|||||||Spearman Correlation Coefficient|||MCS- 12: Total Number of CPFs per Participant||||=0.7846
70856100|NCT04876690|141198775|SUPERIORITY||||||=|0.3972|||||||Pearson Correlation Coefficient|||MCS- 12: Time Since Seton Placement||||=0.3972
70856101|NCT04876690|141198775|SUPERIORITY||||||=|0.9496|||||||Spearman Correlation Coefficient|||MCS- 12: Time Between First CPF Diagnosis Date and Date of Study Visit||||=0.9496
70944465|NCT04159805|141389040|SUPERIORITY||Difference in LS Mean|0.52|||=|0.687|TWO_SIDED|95.0|-2.1|3.13||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||3.13|-2.10|=0.687
71083520|NCT00873730|141673072|SUPERIORITY_OR_OTHER|||||||0.3476|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Physical functioning.||||0.3476
71083521|NCT00873730|141673072|SUPERIORITY_OR_OTHER|||||||0.9045|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Physical role limitations.||||0.9045
71083522|NCT00873730|141673072|SUPERIORITY_OR_OTHER|||||||0.8558|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Bodily pain.||||0.8558
71083523|NCT00873730|141673072|SUPERIORITY_OR_OTHER|||||||0.3123|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for General health.||||0.3123
71083524|NCT00873730|141673072|SUPERIORITY_OR_OTHER|||||||0.3327|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Vitality.||||0.3327
71083525|NCT00873730|141673072|SUPERIORITY_OR_OTHER|||||||0.8334|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Social functioning.||||0.8334
71122037|NCT00394901|141750171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.04||||0.559||95.0|-2.45|4.53|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||4.53|-2.45|0.559
70856102|NCT04876690|141198775|SUPERIORITY||||||=|0.813|||||||Pearson Correlation Coefficient|||MCS- 12: PDAI Score||||=0.8130
71083526|NCT00873730|141673072|SUPERIORITY_OR_OTHER|||||||0.7998|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Emotional role limitations.||||0.7998
71083527|NCT00873730|141673072|SUPERIORITY_OR_OTHER|||||||0.7125|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Mental health.||||0.7125
71083528|NCT00873730|141673074|SUPERIORITY_OR_OTHER|||||||0.7404|||||||Wilcoxon (Mann-Whitney)|||||||0.7404
71083529|NCT04391179|141673100|SUPERIORITY||Slope|-0.033|STANDARD_ERROR_OF_MEAN|0.027||0.24|TWO_SIDED|95.0|-0.089|0.023|||Mixed Models Analysis||Estimation represents log-scale difference between average daily change in D-Dimer for Dipyridamole patients minus placebo average daily change. Negative estimates indicate that D-Dimer levels decline faster in Dipyridamole versus placebo patients.|||.023|-.089|0.24
71083530|NCT04391179|141673101|SUPERIORITY||win ratio|1.0||||0.98|TWO_SIDED|97.8|0.78|1.29|||Mantel Haenszel||win ratio= (the probability of a win for the dipyridamole patient)/(probability of a win for the placebo patient)|A win ratio analysis of the hierarchical composite outcome requiring direct comparison of outcomes between each dipyridamole patient and placebo patient. The patient with the superior outcome is adjudicated the 'winner' and receives a +1 score, while the 'loser' scores -1.||1.29|0.78|.98
71083531|NCT04391179|141673102|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||.08
71083532|NCT04391179|141673103|SUPERIORITY|||||||0.09|||||||Log Rank|||||||.09
71083533|NCT04391179|141673104|SUPERIORITY||Mean Difference (Net)|0.29||||0.36|TWO_SIDED|95.0|0.02|3.94|||regression, negative binomial||estimated ratio of days on mechanical ventilation for dipyridamole and placebo|||3.94|0.02|0.36
70856103|NCT04876690|141198775|SUPERIORITY||||||=|0.4588|||||||Spearman Correlation Coefficient|||MCS- 12: Number of Internal Fistula Openings per Participant||||=0.4588
70856104|NCT04876690|141198775|SUPERIORITY||||||=|0.8663|||||||Spearman Correlation Coefficient|||MCS- 12: Number of External Fistula Openings per Participant||||=0.8663
70856105|NCT04876690|141198775|SUPERIORITY||||||=|0.1349|||||||Pearson Correlation Coefficient|||MCS- 12: SIBDQ Score||||=0.1349
70856106|NCT04876690|141198775|SUPERIORITY||||||=|0.5647|||||||Pearson Correlation Coefficient|||MCS- 12: SQoL-M Score||||=0.5647
70856107|NCT04876690|141198775|SUPERIORITY||||||=|0.9509|||||||Pearson Correlation Coefficient|||MCS- 12: SQoL-F Score||||=0.9509
70856108|NCT04876690|141198775|SUPERIORITY||||||=|0.5328|||||||Pearson Correlation Coefficient|||MCS- 12: Wexner Score||||=0.5328
70856109|NCT00899353|141198784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|2.7||0.78|TWO_SIDED|95.0|-5.0|11.2|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on global response."||11.2|-5.0|0.78
70856110|NCT00899353|141198784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|2.5||0.75|TWO_SIDED|95.0|-4.6|10.7|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on global response."||10.7|-4.6|0.75
71083534|NCT04391179|141673105|SUPERIORITY||Odds Ratio (OR)|1.04||||0.94|TWO_SIDED|95.0|0.43|2.51|||Regression, Logistic||Odds of a 50 point drop in the dipyridamole group relative to the placebo group.|||2.51|0.43|.94
71083535|NCT04391179|141673106|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||.95
71083536|NCT00105989|141673138|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No adjustments were made for multiple comparisons. The primary efficacy analysis compared the time to recurrence during the maintenance phase between all duloxetine and placebo patients using the log-rank test, stratified by country at α=.05.|Log Rank|The log rank method provides a single p-value comparing time to depressive recurrence for placebo and duloxetine.||A total of 257 randomized patients (randomly assigned with equal probability to the two treatment groups) were needed to have 90% power to detect 40% versus 20% recurrence rates over 52 weeks, using a log rank test at a two-sided significance level of .05.||||<0.001
71122038|NCT00394901|141750172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.4||||0.004||95.0|3.01|15.78|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||15.78|3.01|0.004
71122039|NCT00394901|141750172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.67||||0.037||95.0|0.39|12.95|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.95|0.39|0.037
71122040|NCT00394901|141750172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.46||||0.643||95.0|-4.74|7.66|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||7.66|-4.74|0.643
71122041|NCT00394901|141750173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.62||||0.811||95.0|-4.5|5.75|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.75|-4.50|0.811
71122042|NCT00394901|141750173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.07||||0.006||95.0|2.03|12.12|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.12|2.03|0.006
71122043|NCT00394901|141750173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.03||||0.047||95.0|0.06|10.0|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||10.00|0.06|0.047
71122044|NCT00394901|141750174|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.3||||0.013||95.0|1.1|9.5|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||9.50|1.10|0.013
71122045|NCT00394901|141750174|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.82||||0.07||95.0|-0.31|7.96|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||7.96|-0.31|0.070
71122046|NCT00394901|141750174|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.93||||0.058||95.0|-0.13|8.0|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||8.00|-0.13|0.058
71122047|NCT00394901|141750175|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.43||||0.443||95.0|-3.79|8.65|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||8.65|-3.79|0.443
71122048|NCT00394901|141750175|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.41||||0.018||95.0|1.28|13.54|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||13.54|1.28|0.018
71122049|NCT00394901|141750175|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.83||||0.549||95.0|-4.18|7.85|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||7.85|-4.18|0.549
71122050|NCT00394901|141750176|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.15||||0.075||95.0|-0.63|12.92|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.92|-0.63|0.075
71122051|NCT00394901|141750176|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.41||||0.111||95.0|-1.25|12.08|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.08|-1.25|0.111
71122052|NCT00394901|141750176|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.02||||0.366||95.0|-3.55|9.6|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||9.60|-3.55|0.366
71122053|NCT00394901|141750177|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.64||||0.039||95.0|0.29|11.0|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||11.00|0.29|0.039
71122054|NCT00394901|141750177|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.42||||0.006||95.0|2.14|12.69|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.69|2.14|0.006
71122055|NCT00394901|141750177|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.15||||0.117||95.0|-1.05|9.34|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||9.34|-1.05|0.117
71122056|NCT00394901|141750178|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.99||||0.154||95.0|-1.5|9.49|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05||9.49|-1.50|0.154
71122057|NCT00394901|141750178|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.99||||0.012||95.0|1.58|12.4|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.40|1.58|0.012
71122058|NCT00394901|141750178|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.76||||0.079||95.0|-0.56|10.08|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||10.08|-0.56|0.079
71122059|NCT00394901|141750179|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.28||||0.6451||95.0|0.45|3.59|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.59|0.45|0.6451
71122060|NCT00394901|141750179|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.56||||0.0745||95.0|0.91|7.19|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||7.19|0.91|0.0745
70856111|NCT00899353|141198784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|2.3||0.08|TWO_SIDED|95.0|-0.6|13.7|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on global response."||13.7|-0.6|0.08
71083537|NCT00105989|141673139|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Frequencies are analyzed using Cochran-Mantel-Haenszel controlling for investigator||||||<0.001
71083538|NCT00105989|141673140|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Log Rank|The log rank method provides a single p-value comparing time to depressive recurrence for placebo and duloxetine.||||||0.003
71083539|NCT00105989|141673141|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Cochran-Mantel-Haenszel|Frequencies were analyzed using Cochran-Mantel-Haenszel controlling for investigator.||||||0.003
71083540|NCT00105989|141673142|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71083541|NCT00105989|141673142|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.016
71083542|NCT00105989|141673143|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71083543|NCT00105989|141673144|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71083544|NCT00105989|141673144|SUPERIORITY_OR_OTHER|||||||0.153||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.153
71083545|NCT00105989|141673145|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71083546|NCT00105989|141673146|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean value at endpoint is significant from 4.||||||<0.001
71083547|NCT00105989|141673146|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean value at endpoint is significant from 4.||||||<0.001
71083548|NCT00105989|141673147|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71083549|NCT00105989|141673148|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for Change from Baseline to Endpoint for all Subscales during Acute phase were \<0.001.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71083550|NCT00105989|141673148|SUPERIORITY_OR_OTHER|||||||0.334||95.0||||P-value for Anxiety Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.334
71083551|NCT00105989|141673148|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-value for Core Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.019
71083552|NCT00105989|141673148|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||P-value for Maier Change from Baseline to Endpoint.|t-test, 2 sided|t-test assessses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.046
71083553|NCT00105989|141673148|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Retardation Change from Baseline to Endpoint.|t-test, 2 sided|t-test assessses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71083554|NCT00105989|141673148|SUPERIORITY_OR_OTHER|||||||0.319||95.0||||P-value for Sleep Change from Baseline to Endpoint.|t-test, 2 sided|t-test assessses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.319
71083555|NCT00105989|141673148|SUPERIORITY_OR_OTHER|||||||0.275||95.0||||P-value for Depressed Mood Change from Baseline to Endpoint.|t-test, 2 sided|t-test assessses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.275
70856112|NCT00899353|141198784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|STANDARD_ERROR_OF_MEAN|2.4||0.17|TWO_SIDED|95.0|-1.6|13.2|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on global response."||13.2|-1.6|0.17
71083556|NCT00105989|141673149|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Pairwise comparison of Least Squares Means for Anxiety Subscale Change from Baseline to Endpoint.|t-test, 2 sided|||||||<0.001
71083557|NCT00105989|141673149|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Pairwise comparison of Least Squares Means for Core Subscale Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.002
71083558|NCT00105989|141673149|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Pairwise comparison of Least Squares Means for Maier Subscale Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.002
71083559|NCT00105989|141673149|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Pairwise comparison of Least Squares Means for Retardation Subscale Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.003
71083560|NCT00105989|141673149|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Pairwise comparison of Least Squares Means for Sleep Subscale Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.001
71083561|NCT00105989|141673149|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Pairwise comparison of Least Squares Means for Depressed Mood Subscale Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.003
71083562|NCT00105989|141673150|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for all Change from Baseline to Endpoint measures in the Acute Phase were \<0.001.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71083563|NCT00105989|141673150|SUPERIORITY_OR_OTHER|||||||0.273||95.0||||P-value for Overall Pain Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.273
71083564|NCT00105989|141673150|SUPERIORITY_OR_OTHER|||||||0.968||95.0||||P-value for Headache Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.968
71083565|NCT00105989|141673150|SUPERIORITY_OR_OTHER|||||||0.998||95.0||||P-value for Back Pain Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.998
71083566|NCT00105989|141673150|SUPERIORITY_OR_OTHER|||||||0.703||95.0||||P-value for Shoulder Pain Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.703
71083567|NCT00105989|141673150|SUPERIORITY_OR_OTHER|||||||0.346||95.0||||P-value for Interference with Daily Activities Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.346
71083568|NCT00105989|141673150|SUPERIORITY_OR_OTHER|||||||0.963||95.0||||P-value for Pain While Awake Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.963
71083569|NCT00105989|141673151|SUPERIORITY_OR_OTHER|||||||0.792||95.0||||P-value for pairwise comparison of Least Squares Means for Overall Pain Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.792
71083570|NCT00105989|141673151|SUPERIORITY_OR_OTHER|||||||0.407||95.0||||P-value for pairwise comparison of Least Squares Means for Headache Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.407
70856113|NCT00899353|141198784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3|STANDARD_ERROR_OF_MEAN|3.7||0.61|TWO_SIDED|95.0|-6.5|17.2|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on High Initial NFkB Activation Expressers."||17.2|-6.5|0.61
71083571|NCT00105989|141673151|SUPERIORITY_OR_OTHER|||||||0.475||95.0||||P-value for pairwise comparison of Least Squares Means for Back Pain Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.475
71083572|NCT00105989|141673151|SUPERIORITY_OR_OTHER|||||||0.241||95.0||||P-value for pairwise comparison of Least Squares Means for Shoulder Pain Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.241
71083573|NCT00105989|141673151|SUPERIORITY_OR_OTHER|||||||0.885||95.0||||P-value for pairwise comparison of Least Squares Means for Interference with Daily Activities Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.885
71083574|NCT00105989|141673151|SUPERIORITY_OR_OTHER|||||||0.717||95.0||||P-value for pairwise comparison of Least Squares Means for Pain While Awake Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.717
71083575|NCT00105989|141673152|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71083576|NCT00105989|141673152|SUPERIORITY_OR_OTHER|||||||0.157||95.0||||P-value for Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.157
71083577|NCT00105989|141673153|SUPERIORITY_OR_OTHER|||||||0.979||95.0|||||t-test, 2 sided|||||||0.979
71083578|NCT00105989|141673154|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline to Endpoint in all SDS items in Acute Phase were \<0.001.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71083579|NCT00105989|141673154|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline to Endpoint in all SDS items in the Continuation Phase were \<0.001.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71083580|NCT00105989|141673155|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value for pairwise comparison of Least Squares Means for Change from Baseline to Endpoint in Global Score|t-test, 2 sided|||||||0.029
71083581|NCT00105989|141673155|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for pairwise comparison of Least Squares Means for Change from Baseline to Endpoint in Work/School.|t-test, 2 sided|||||||0.022
70856114|NCT00899353|141198784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3|STANDARD_ERROR_OF_MEAN|3.1||0.32|TWO_SIDED|95.0|-4.1|16.8|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on High Initial NFkB Activation Expressers."||16.8|-4.1|0.32
70944466|NCT04159805|141389040|SUPERIORITY||Difference in LS Mean|-1.24|||=|0.374|TWO_SIDED|95.0|-4.05|1.57||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||1.57|-4.05|=0.374
71083582|NCT00105989|141673155|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||P-value for pairwise comparison of Least Squares Means for Change from Baseline to Endpoint in Social Life.|t-test, 2 sided|||||||0.110
71083583|NCT00105989|141673155|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value for pairwise comparison of Least Squares Means for Change from Baseline to Endpoint in Family Life/Home Responsibilities.|t-test, 2 sided|||||||0.021
71083584|NCT00105989|141673156|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for Change from Baseline to Endpoint in all SF-36 subscales in the Acute Phase were \<0.001|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71083585|NCT00105989|141673156|SUPERIORITY_OR_OTHER|||||||0.947||95.0||||P-value for Physical Component Summary Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.947
71083586|NCT00105989|141673156|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Mental Component Summary Change to Endpoint|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71083587|NCT00105989|141673156|SUPERIORITY_OR_OTHER|||||||0.118||95.0||||P-value for Physical Functioning Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.118
71083588|NCT00105989|141673156|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||P-value for Bodily Pain Change from Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.550
71083589|NCT00105989|141673156|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value for Role Limitations Due to Physical Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.029
71083590|NCT00105989|141673156|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Role Limitations Due to Emotional Problems Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71083591|NCT00105989|141673156|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for General Health Perceptions Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.002
71083592|NCT00105989|141673156|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Mental Health Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71083593|NCT00105989|141673156|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Social Function Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71083594|NCT00105989|141673156|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Vitality Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71083595|NCT00105989|141673156|SUPERIORITY_OR_OTHER|||||||0.815||95.0||||P-value for Rate Current Health Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.815
71083596|NCT00105989|141673156|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Health Compared to a Year Ago Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71083597|NCT00105989|141673157|SUPERIORITY_OR_OTHER|||||||0.415||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Physical Component Summary.|t-test, 2 sided|||||||0.415
71083598|NCT00105989|141673157|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Mental Component Summary.|t-test, 2 sided|||||||0.002
71083599|NCT00105989|141673157|SUPERIORITY_OR_OTHER|||||||0.731||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Physical Functioning.|t-test, 2 sided|||||||0.731
71083600|NCT00105989|141673157|SUPERIORITY_OR_OTHER|||||||0.438||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Bodily Pain.|t-test, 2 sided|||||||0.438
71083601|NCT00105989|141673157|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Role Limitations Due to Physical.|t-test, 2 sided|||||||0.029
71083602|NCT00105989|141673157|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Role Limitations Due to Emotional problems.|t-test, 2 sided|||||||0.003
71083603|NCT00105989|141673157|SUPERIORITY_OR_OTHER|||||||0.391||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-General Health Perceptions.|t-test, 2 sided|||||||0.391
71083604|NCT00105989|141673157|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Mental Health.|t-test, 2 sided|||||||0.001
70856115|NCT00899353|141198784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.0|STANDARD_ERROR_OF_MEAN|2.8||0.03|TWO_SIDED|95.0|1.6|22.3|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on High Initial NFkB Activation Expressers."||22.3|1.6|0.03
70856116|NCT00899353|141198784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.1|STANDARD_ERROR_OF_MEAN|3.1||0.04|TWO_SIDED|95.0|0.5|21.8|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on High Initial NFkB Activation Expressers."||21.8|0.5|0.04
70856117|NCT00899353|141198784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.4||1|TWO_SIDED|95.0|-1.5|1.2|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on Low Initial NFkB Activation Expressers."||1.2|-1.5|1.00
70856118|NCT00899353|141198784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.7||0.88|TWO_SIDED|95.0|-3.5|2.3|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on Low Initial NFkB Activation Expressers."||2.3|-3.5|0.88
70944467|NCT04159805|141389040|SUPERIORITY||Difference in LS Mean|0.99|||=|0.478|TWO_SIDED|95.0|-1.82|3.8||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||3.80|-1.82|=0.478
70954307|NCT02917603|141411105|EQUIVALENCE|Null hypothesis is there will be the mean differences between baseline scores will be the same between groups. Study powered after primary outcome measure.|Mean Difference (Net)|0.23|||<|0.73|TWO_SIDED||||||t-test, 2 sided|||||||<.73
70856119|NCT00899353|141198784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.98|TWO_SIDED|95.0|-0.8|1.0|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on Low Initial NFkB Activation Expressers."||1.0|-0.8|0.98
70944468|NCT04159805|141389040|SUPERIORITY||Difference in LS Mean|-0.51|||=|0.69|TWO_SIDED|95.0|-3.12|2.09||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||2.09|-3.12|=0.690
71122061|NCT00394901|141750179|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.01||||0.1787||95.0|0.73|5.58|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.58|0.73|0.1787
71122062|NCT00394901|141750180|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.26||||0.0732||95.0|0.93|5.52|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.52|0.93|0.0732
71122063|NCT00394901|141750180|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.64||||0.0353||95.0|1.07|6.53|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||6.53|1.07|0.0353
71122064|NCT00394901|141750180|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.5||||0.0393||95.0|1.05|5.96|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.96|1.05|0.0393
71122065|NCT00394901|141750181|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.227||95.0|-0.78|0.18|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.18|-0.78|0.227
71122066|NCT00394901|141750181|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.86|||<|0.001||95.0|-1.34|-0.38|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.38|-1.34|<0.001
71122067|NCT00394901|141750181|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.93|||<|0.001||95.0|-1.4|-0.46|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.46|-1.40|<0.001
71122068|NCT00394901|141750182|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14||||0.577||95.0|-0.62|0.35|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.35|-0.62|0.577
71122069|NCT00394901|141750182|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.87|||<|0.001||95.0|-1.35|-0.39|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.39|-1.35|<0.001
71122070|NCT00394901|141750182|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74||||0.002||95.0|-1.22|-0.27|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.27|-1.22|0.002
71122071|NCT00394901|141750183|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.27||||0.275||95.0|-0.75|0.21|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.21|-0.75|0.275
71122072|NCT00394901|141750183|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.98|||<|0.001||95.0|-1.46|-0.5|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.50|-1.46|<0.001
71122073|NCT00394901|141750183|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75||||0.002||95.0|-1.22|-0.28|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.28|-1.22|0.002
71122074|NCT00394901|141750184|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24||||0.334||95.0|-0.72|0.25|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.25|-0.72|0.334
71122075|NCT00394901|141750184|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9|||<|0.001||95.0|-1.38|-0.42|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.42|-1.38|<0.001
71122076|NCT00394901|141750184|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66||||0.006||95.0|-1.14|-0.19|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.19|-1.14|0.006
71122077|NCT00394901|141750185|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15||||0.53||95.0|-0.64|0.33|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.33|-0.64|0.530
71122078|NCT00394901|141750185|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.82||||0.001||95.0|-1.3|-0.33|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.33|-1.30|0.001
71122079|NCT00394901|141750185|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.58||||0.017||95.0|-1.05|-0.1|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.10|-1.05|0.017
70856120|NCT00899353|141198784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.2||0.98|TWO_SIDED|95.0|-6.6|5.3|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on Low Initial NFkB Activation Expressers."||5.3|-6.6|0.98
70856121|NCT02650921|141198825|SUPERIORITY||Difference in Responder Rate|64.7|||<|0.0001|TWO_SIDED|95.0|53.3|76.1|||McNemar|||||76.1|53.3|<0.0001
70856122|NCT02650921|141198826|SUPERIORITY||Difference in Responder Rate|72.3|||<|0.0001|TWO_SIDED|95.0|61.9|82.7|||McNemar|||||82.7|61.9|<0.0001
71083605|NCT00105989|141673157|SUPERIORITY_OR_OTHER|||||||0.142||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Social Functioning.|t-test, 2 sided|||||||0.142
71083606|NCT00105989|141673157|SUPERIORITY_OR_OTHER|||||||0.24||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Vitality.|t-test, 2 sided|||||||0.240
71083607|NCT00105989|141673157|SUPERIORITY_OR_OTHER|||||||0.615||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Rate General Health.|t-test, 2 sided|||||||0.615
71083608|NCT00105989|141673157|SUPERIORITY_OR_OTHER|||||||0.218||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Health Compared to a Year Ago.|t-test, 2 sided|||||||0.218
71083609|NCT00105989|141673158|SUPERIORITY_OR_OTHER|||||||0.838||95.0||||P-value for change in number of Primary Health Care Provider Visits in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.838
71083610|NCT00105989|141673158|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change in number of Psychiatrist visits in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71083611|NCT00105989|141673158|SUPERIORITY_OR_OTHER|||||||0.236||95.0||||P-value for change in number of Psychologist/Therapist visits in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.236
71083612|NCT00105989|141673158|SUPERIORITY_OR_OTHER|||||||0.145||95.0||||P-value for change in number of Other Specialist Physician visits in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.145
71083613|NCT00105989|141673158|SUPERIORITY_OR_OTHER|||||||0.423||95.0||||P-value for change in number of Other (Specified by Patient) visits in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.423
71083614|NCT00105989|141673158|SUPERIORITY_OR_OTHER|||||||0.325||95.0||||P-value for change in number of Primary Health Care Provider visits in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.325
70856123|NCT02650921|141198827|SUPERIORITY||Difference in Responder Rate|57.3|||<|0.0001|TWO_SIDED|95.0|44.8|69.8|||McNemar|||||69.8|44.8|<0.0001
70856124|NCT02650921|141198828|SUPERIORITY||Difference in Responder Rate|45.8|||<|0.0001|TWO_SIDED|95.0|32.3|59.3|||McNemar|||||59.3|32.3|<0.0001
71083615|NCT00105989|141673158|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change in number of Psychiatrist visits in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
70856125|NCT03400956|141198897|SUPERIORITY||Risk Difference (RD)|0.82|||<|0.0001|TWO_SIDED|95.0|0.72|0.93|||Cochran-Mantel-Haenszel||Number of subjects per treatment: 63 (Vilaprisan) / 33 (Placebo).|Vilaprisan (A1) and Vilaprisan+Placebo (B2) combined vs. Placebo+Vilaprisan (B1) in treatment period 1||0.93|0.72|<.0001
71083616|NCT00105989|141673158|SUPERIORITY_OR_OTHER|||||||0.915||95.0||||P-value for change in number of Psychologist/Therapist visits in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.915
70856126|NCT00160667|141198904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|||=|0.965|TWO_SIDED|95.0|-12.82|13.41|||ANCOVA||Estimated value is the difference of Least Square Means.|||13.41|-12.82|=0.965
70856127|NCT00160667|141198904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.48|||=|0.825|TWO_SIDED|95.0|-11.69|14.65|||ANCOVA||Estimated value is the difference of Least Square Means.|||14.65|-11.69|=0.825
70856128|NCT03044574|141198924|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
70856129|NCT03044574|141198925|SUPERIORITY|||||||0.03|||||||Fisher Exact|||||||0.03
70856130|NCT03044574|141198926|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
70856131|NCT03044574|141198927|SUPERIORITY|||||||0.03|||||||Fisher Exact|||||||0.03
70856132|NCT03044574|141198928|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
70856133|NCT03044574|141198929|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
70856134|NCT03044574|141198930|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
70856135|NCT03044574|141198932|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
70856136|NCT01402427|141198940|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.01||||0.28|TWO_SIDED|95.0|-0.011|0.033|||Fisher Exact|||||0.033|-0.011|0.28
70856137|NCT01402427|141198941|SUPERIORITY_OR_OTHER|||||||0.11|||||||Fisher Exact|||||||0.11
70856138|NCT01402427|141198942|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
70856139|NCT01402427|141198943|SUPERIORITY_OR_OTHER|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
70944469|NCT04159805|141389040|SUPERIORITY||Difference in LS Mean|2.12|||=|0.106|TWO_SIDED|95.0|-0.48|4.71||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||4.71|-0.48|=0.106
71083617|NCT00105989|141673158|SUPERIORITY_OR_OTHER|||||||0.223||95.0||||P-value for change in number of Other Specialist Physician visits in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.223
70856140|NCT01402427|141198944|SUPERIORITY_OR_OTHER|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||||||0.28
70856141|NCT01402427|141198945|SUPERIORITY_OR_OTHER|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
70856142|NCT01402427|141198946|SUPERIORITY_OR_OTHER|||||||0.45|||||||Fisher Exact|||||||0.45
70856143|NCT04355728|141198948|SUPERIORITY|||||||0.04|||||||Fisher Exact|||"The null hypothesis is the following: There is no difference in the number of subjects experiencing serious adverse events in the UC-MSC vs control group."||||.04
70856144|NCT04355728|141198957|SUPERIORITY||Hazard Ratio (HR)|0.289||||0.0307|TWO_SIDED|95.0|0.088|0.948|||Log Rank||Censoring was limited to dropout from study, and the event of interest was recovery. In the case of death, the patient's time to recovery was censored at the end of study observation; thus the patient remained in the risk set for all KM estimations.|"The null hypothesis is the following: There is no difference in Time to Recovery up to 31 days post infusion between the UC-MSC group and control group. Time to recovery was estimated in each group with Kaplan-Meier survival estimates. Log-rank tests were used to compare hazards between groups."||0.948|0.088|0.0307
70856145|NCT04355728|141198958|SUPERIORITY|||||||0.0563|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis: The center of the distributions of ventilator free days are equal in the UC-MSC and control group.||||.0563
70856146|NCT04355728|141198959|SUPERIORITY|||||||0.0563|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis: The center of the distributions of ventilator free days are equal in the UC-MSC and control group.||||.0563
70856147|NCT04355728|141198990|SUPERIORITY|||||||0.0356|||||||Wilcoxon (Mann-Whitney)|||||||0.0356
70856148|NCT04355728|141198991|SUPERIORITY|||||||0.0215|||||||Wilcoxon (Mann-Whitney)|||||||0.0215
70856149|NCT04355728|141198992|SUPERIORITY||Mean Difference (Net)|-3498.0|STANDARD_DEVIATION|3078.2||0.021|TWO_SIDED|95.0|-6404.7|-591.2|||t-test, 2 sided|||||-591.2|-6404.7|0.0210
70856150|NCT04355728|141198994|SUPERIORITY|||||||0.48|||||||Fisher Exact|||"The null hypothesis is the following: There is no association between PRA (class I) status and treatment group at 3 days post first infusion."||||0.48
70856151|NCT04355728|141198994|SUPERIORITY|||||||0.41|||||||Fisher Exact|||"The null hypothesis is the following: There is no association between PRA (class II) status and treatment group at 3 days post first infusion."||||0.41
70856152|NCT04355728|141198995|SUPERIORITY|||||||1|||||||Fisher Exact|||"The null hypothesis is the following: There is no association between PRA (class I) status and treatment group at 6 days post first infusion."||||1.00
70856153|NCT04355728|141198995|SUPERIORITY|||||||1|||||||Fisher Exact|||"The null hypothesis is the following: There is no association between PRA (Class II) status and treatment group at 6 days post first infusion."||||1.00
70856154|NCT04355728|141198996|SUPERIORITY|||||||0.44|||||||Fisher Exact|||"The null hypothesis is the following: There is no association between PRA (class I) status and treatment group at 14 days post first infusion."||||0.44
70856155|NCT04355728|141198996|SUPERIORITY|||||||0.5238|||||||Fisher Exact|||"The null hypothesis is the following: There is no association between PRA (class II) status and treatment group at 14 days post first infusion."||||0.5238
70944470|NCT04159805|141389040|SUPERIORITY||Difference in LS Mean|-0.89|||=|0.547|TWO_SIDED|95.0|-3.89|2.12||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||2.12|-3.89|=0.547
70856156|NCT00906971|141199018|NON_INFERIORITY_OR_EQUIVALENCE|Statistical analysis to compare the two groups at the end of the follow-up period with regard to the primary outcome measures was blind, by intention-to-treat, considering loss of follow-up as treatment failure. In such cases, at the end of the follow-up period, the frequency of defecations was recorded.|||||<|0.05|||||||t-test, 1 sided|The Mann-Whitney test was used for numerical variables with non-normal distribution.||||||<0.05
70944471|NCT04159805|141389040|SUPERIORITY||Difference in LS Mean|2.19|||=|0.144|TWO_SIDED|95.0|-0.81|5.18||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||5.18|-0.81|=0.144
71083618|NCT00105989|141673158|SUPERIORITY_OR_OTHER|||||||0.362||95.0||||P-value for change in number of Other (Specified by Patient) visits in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.362
71083619|NCT00105989|141673159|SUPERIORITY_OR_OTHER|||||||0.462||95.0||||P-value for pairwise comparison of means for change from baseline to endpoint in Primary Health Care Provider visits.|t-test, 2 sided|||||||0.462
70944472|NCT04159805|141389040|SUPERIORITY||Difference in LS Mean|-1.37|||=|0.431|TWO_SIDED|95.0|-4.91|2.17||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||2.17|-4.91|=0.431
71083620|NCT00105989|141673159|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||P-value for pairwise comparison of means for change from baseline to endpoint in Psychiatrist visits.|t-test, 2 sided|||||||0.668
70944473|NCT04159805|141389040|SUPERIORITY||Difference in LS Mean|1.2|||=|0.488|TWO_SIDED|95.0|-2.34|4.74|||MMRM|||Change From Baseline at Week 16||4.74|-2.34|=0.488
71083621|NCT00105989|141673159|SUPERIORITY_OR_OTHER|||||||0.746||95.0||||P-value for pairwise comparison of means for change from baseline to endpoint in Psychologist/Therapist visits.|t-test, 2 sided|||||||0.746
71083622|NCT00105989|141673159|SUPERIORITY_OR_OTHER|||||||0.511||95.0||||P-value for pairwise comparison of means for change from baseline to endpoint in Other Specialist Physician visits.|t-test, 2 sided|||||||0.511
71083623|NCT00105989|141673159|SUPERIORITY_OR_OTHER|||||||0.271||95.0||||P-value for pairwise comparison of means for change from baseline to endpoint in Other (Specified by Patient) Provider visits.|t-test, 2 sided|||||||0.271
71083624|NCT00105989|141673160|SUPERIORITY_OR_OTHER|||||||0.506||95.0||||P-value for Change in Average Number of Hours Worked In a Week in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.506
71083625|NCT00105989|141673160|SUPERIORITY_OR_OTHER|||||||0.057||95.0||||P-value for Change in Average Number of Hours Worked In a Week in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.057
71083626|NCT00105989|141673161|SUPERIORITY_OR_OTHER|||||||0.826||95.0|||||t-test, 2 sided|||||||0.826
71083627|NCT00105989|141673162|SUPERIORITY_OR_OTHER|||||||0.105||95.0||||P-value for Change in Number of Missed Paid Work Hours in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.105
71083628|NCT00105989|141673162|SUPERIORITY_OR_OTHER|||||||0.174||95.0||||P-value for Change in Number of Missed Paid Work Hours in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.174
71083629|NCT00105989|141673163|SUPERIORITY_OR_OTHER|||||||0.037||95.0|||||t-test, 2 sided|||||||0.037
71083630|NCT00105989|141673164|SUPERIORITY_OR_OTHER|||||||0.785||95.0||||P-value for Sum Items 1 to 5 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.785
71083631|NCT00105989|141673164|SUPERIORITY_OR_OTHER|||||||0.354||95.0||||P-value for Sum Items 1\&2 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.354
71083632|NCT00105989|141673164|SUPERIORITY_OR_OTHER|||||||0.17||95.0||||P-value for Item 1-Sex Drive Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.170
71083633|NCT00105989|141673164|SUPERIORITY_OR_OTHER|||||||0.825||95.0||||P-value for Item 2-Arousal Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.825
71083634|NCT00105989|141673164|SUPERIORITY_OR_OTHER|||||||0.877||95.0||||P-value for Item 3-Vaginal Lubrication/Penile Erection Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.877
71083635|NCT00105989|141673164|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for Item 4-Orgasm Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.009
71083636|NCT00105989|141673164|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||P-value for Item 5-Satisfaction Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.670
71083637|NCT00105989|141673164|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||P-value for Sum Items 1 to 5 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.100
71083638|NCT00105989|141673164|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value for Sum Items 1\&2 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.021
71083639|NCT00105989|141673164|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-value for Item 1-Sex Drive Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.047
71083640|NCT00105989|141673164|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value for Item 2-Arousal Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.023
71083641|NCT00105989|141673164|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||P-value for Item 3-Vaginal Lubrication/Penile Erection Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.668
71083642|NCT00105989|141673164|SUPERIORITY_OR_OTHER|||||||0.136||95.0||||P-value for Item 4-Orgasm Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.136
71083643|NCT00105989|141673164|SUPERIORITY_OR_OTHER|||||||0.152||95.0||||P-value for Item 5-Satisfaction Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.152
71083644|NCT00105989|141673165|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Sum Items 1 to 5 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71083645|NCT00105989|141673165|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Sum Items 1\&2 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71083646|NCT00105989|141673165|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Item 1-Sex Drive Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
70944474|NCT04159805|141389041|SUPERIORITY||Difference in LS Mean|-0.34|||=|0.855|TWO_SIDED|95.0|-4.14|3.45||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||3.45|-4.14|=0.855
71122080|NCT00394901|141750186|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.21||||0.392||95.0|-0.7|0.27|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.27|-0.70|0.392
71083647|NCT00105989|141673165|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Item 2-Arousal Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71083648|NCT00105989|141673165|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Item 3-Vaginal Lubrication/Penile Erection Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.005
71083649|NCT00105989|141673165|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value for Item 4-Orgasm Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.050
71083650|NCT00105989|141673165|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for Item 5-Satisfaction Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.022
71083651|NCT00105989|141673165|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Sum Items 1 to 5 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.002
71122081|NCT00394901|141750186|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87|||<|0.001||95.0|-1.35|-0.38|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.38|-1.35|<0.001
71122082|NCT00394901|141750186|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.58||||0.016||95.0|-1.06|-0.11|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.11|-1.06|0.016
71083652|NCT00105989|141673165|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Sum Items 1\&2 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71083653|NCT00105989|141673165|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Item 1-Sex Drive Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71083654|NCT00105989|141673165|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Item 2-Arousal Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71083655|NCT00105989|141673165|SUPERIORITY_OR_OTHER|||||||0.186||95.0||||P-value for Item 3-Vaginal Lubrication/Penile Erection Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.186
71083656|NCT00105989|141673165|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Item 4-Orgasm Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71083657|NCT00105989|141673165|SUPERIORITY_OR_OTHER|||||||0.308||95.0||||P-value for Item 5-Satisfaction Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.308
71122083|NCT00394901|141750187|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22||||0.364||95.0|-0.71|0.26|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.26|-0.71|0.364
71122084|NCT00394901|141750187|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.91|||<|0.001||95.0|-1.39|-0.42|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.42|-1.39|<0.001
70944475|NCT04159805|141389041|SUPERIORITY||Difference in LS Mean|3.19|||=|0.093|TWO_SIDED|95.0|-0.56|6.95||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||6.95|-0.56|=0.093
70944476|NCT04159805|141389041|SUPERIORITY||Difference in LS Mean|1.8|||=|0.41|TWO_SIDED|95.0|-2.61|6.2||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||6.20|-2.61|=0.410
70944477|NCT04159805|141389041|SUPERIORITY||Difference in LS Mean|3.13|||=|0.154|TWO_SIDED|95.0|-1.25|7.5||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||7.50|-1.25|=0.154
71083658|NCT00105989|141673166|SUPERIORITY_OR_OTHER|||||||0.773||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for the Sum of Items 1 to 5.|t-test, 2 sided|||||||0.773
71083659|NCT00105989|141673166|SUPERIORITY_OR_OTHER|||||||0.405||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for the Sum of Items 1 and 2.|t-test, 2 sided|||||||0.405
71083660|NCT00105989|141673166|SUPERIORITY_OR_OTHER|||||||0.443||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 1-Sex Drive.|t-test, 2 sided|||||||0.443
71083661|NCT00105989|141673166|SUPERIORITY_OR_OTHER|||||||0.384||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 2-Arousal.|t-test, 2 sided|||||||0.384
71122085|NCT00394901|141750187|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.52||||0.031||95.0|-1.0|-0.05|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.05|-1.00|0.031
71122086|NCT00394901|141750188|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24||||0.326||95.0|-0.73|0.24|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.24|-0.73|0.326
71122087|NCT00394901|141750188|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.94|||<|0.001||95.0|-1.43|-0.46|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.46|-1.43|<0.001
71122088|NCT00394901|141750188|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.65||||0.007||95.0|-1.13|-0.18|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.18|-1.13|0.007
70944478|NCT04159805|141389041|SUPERIORITY||Difference in LS Mean|-0.94|||=|0.662|TWO_SIDED|95.0|-5.29|3.41||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||3.41|-5.29|=0.662
70944479|NCT04159805|141389041|SUPERIORITY||Difference in LS Mean|3.26|||=|0.13|TWO_SIDED|95.0|-1.02|7.54||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||7.54|-1.02|=0.130
71122089|NCT00394901|141750189|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29||||0.241||95.0|-0.78|0.2|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.20|-0.78|0.241
71122090|NCT00394901|141750189|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85||||0.001||95.0|-1.34|-0.37|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.37|-1.34|0.001
71122091|NCT00394901|141750189|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63||||0.01||95.0|-1.1|-0.15|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.15|-1.10|0.010
71122092|NCT00394901|141750190|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.27||||0.281||95.0|-0.76|0.22|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.22|-0.76|0.281
71083662|NCT00105989|141673166|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 3-Vaginal Lubrication/Penile Erection.|t-test, 2 sided|||||||0.268
71083663|NCT00105989|141673166|SUPERIORITY_OR_OTHER|||||||0.093||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 4-Orgasm.|t-test, 2 sided|||||||0.093
71083664|NCT00105989|141673166|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 5-Satisfaction.|t-test, 2 sided|||||||0.566
71083665|NCT00105989|141673167|SUPERIORITY_OR_OTHER|||||||0.979||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for the Sum of Items 1 to 5.|t-test, 2 sided|||||||0.979
71083666|NCT00105989|141673167|SUPERIORITY_OR_OTHER|||||||0.132||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for the Sum of Items 1 and 2.|t-test, 2 sided|||||||0.132
70856157|NCT00906971|141199019|NON_INFERIORITY_OR_EQUIVALENCE|Statistical analysis to compare the two groups at the end of the follow-up period with regard to the primary outcome measures was blind, by intention-to-treat, considering loss of follow-up as treatment failure. In such cases, at the end of the follow-up period, the frequency of fecal incontinence was recorded reported at the beginning of the study|||||>|0.05|||||||t-test, 1 sided|The Mann-Whitney test was used for numerical variables with non-normal distribution.||||||>0.05
70856158|NCT01340872|141199050|SUPERIORITY||Mean Difference (Final Values)|2.18|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|ONE_SIDED|97.5|1.81||||ANCOVA|||ANCOVA for primary endpoint, Change in Hb concentration from Baseline to Week 12 in double-blind phase, FAS|||1.81|< 0.0001
70944480|NCT04159805|141389041|SUPERIORITY||Difference in LS Mean|1.27|||=|0.586|TWO_SIDED|95.0|-3.44|5.98||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||5.98|-3.44|=0.586
71083667|NCT00105989|141673167|SUPERIORITY_OR_OTHER|||||||0.18||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 1-Sex Drive.|t-test, 2 sided|||||||0.180
71083668|NCT00105989|141673167|SUPERIORITY_OR_OTHER|||||||0.163||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 2-Arousal.|t-test, 2 sided|||||||0.163
71083669|NCT00105989|141673167|SUPERIORITY_OR_OTHER|||||||0.844||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 3-Vaginal Lubrication/Penile Erection.|t-test, 2 sided|||||||0.844
71083670|NCT00105989|141673167|SUPERIORITY_OR_OTHER|||||||0.609||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 4-Orgasm.|t-test, 2 sided|||||||0.609
71083671|NCT00105989|141673167|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 5-Satisfaction.|t-test, 2 sided|||||||0.071
71083672|NCT00105989|141673168|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Weight Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71083673|NCT00105989|141673168|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Weight Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71083674|NCT00105989|141673169|SUPERIORITY_OR_OTHER|||||||0.314||95.0|||||t-test, 2 sided|||||||0.314
71083675|NCT00105989|141673170|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Pulse Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71083676|NCT00105989|141673170|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Pulse Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71083677|NCT00105989|141673171|SUPERIORITY_OR_OTHER|||||||0.891||95.0|||||t-test, 2 sided|||||||0.891
71083678|NCT00105989|141673172|SUPERIORITY_OR_OTHER|||||||0.659||95.0||||P-value for systolic blood pressure change to endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.659
71083679|NCT00105989|141673172|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||P-value for diastolic blood pressure change to endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.064
71083680|NCT00105989|141673172|SUPERIORITY_OR_OTHER|||||||0.224||95.0||||P-value for systolic blood pressure change to endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.224
71083681|NCT00105989|141673172|SUPERIORITY_OR_OTHER|||||||0.21||95.0||||P-value for diastolic blood pressure change to endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.210
71083682|NCT00105989|141673173|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||P-value for Change from Baseline: systolic blood pressure.|t-test, 2 sided|||||||0.134
71083683|NCT00105989|141673173|SUPERIORITY_OR_OTHER|||||||0.816||95.0||||P-value for Change from Baseline: diastolic blood pressure.|t-test, 2 sided|||||||0.816
71083684|NCT00105989|141673174|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
71083685|NCT00105989|141673175|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.007
71083686|NCT00105989|141673176|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.035
71083687|NCT00105989|141673177|SUPERIORITY_OR_OTHER|||||||0.021||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.021
71083688|NCT00105989|141673178|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
71083689|NCT00105989|141673179|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||The mean change to endpoint of -0.00 indicates that on average, endpoint score decreased from baseline score by less than 0.005 units.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.019
71083690|NCT00105989|141673180|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.005
71083691|NCT00105989|141673181|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.031
71083692|NCT00105989|141673182|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
71083693|NCT00105989|141673183|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
71083694|NCT00105989|141673184|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
71083695|NCT00105989|141673185|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
71083696|NCT00105989|141673186|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
71083697|NCT00105989|141673187|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.004
71083698|NCT00105989|141673188|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.010
71083699|NCT00105989|141673189|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.003
71083700|NCT00105989|141673190|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
71083701|NCT00105989|141673191|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.015
70856159|NCT01340872|141199054|SUPERIORITY||Mean Difference (Final Values)|1.04|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|ONE_SIDED|97.5|0.82||||ANCOVA|||ANCOVA analysis of the change in Hb concentration from Baseline to Week 4 of the double-blind phase - Full Analysis Set, multiple imputation|||0.82|< 0.0001
71083702|NCT00105989|141673192|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||The mean change to endpoint of -0.00 indicates that on average, endpoint score decreased from baseline score by less than 0.005 units.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.021
71083703|NCT00105989|141673193|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
71083704|NCT00105989|141673194|SUPERIORITY_OR_OTHER|||||||0.032||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.032
71083705|NCT00105989|141673195|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
71083706|NCT00105989|141673196|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
71083707|NCT00105989|141673197|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.028
71083708|NCT00105989|141673198|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.008
71083709|NCT00105989|141673199|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.046
71083710|NCT00105989|141673200|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||P-value for Change to Endpoint.|ANOVA|Type II Sums of Squares from an analysis of variance (ANOVA) on the Ranks: Model = Pooled Investigator and Therapy.||||||0.035
71083711|NCT00105989|141673201|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for Change to Endpoint.|ANOVA|Type II Sums of Squares from an analysis of variance (ANOVA) on the Ranks: Model = Pooled Investigator and Therapy.||||||0.011
71083712|NCT00105989|141673202|SUPERIORITY_OR_OTHER|||||||0.744||95.0||||P-value for fasting glucose change from baseline to endpoint|ANOVA|Type II Sums of Squares from an analysis of variance (ANOVA) on the Ranks: Model = Pooled Investigator and Therapy.||||||0.744
71083713|NCT00105989|141673202|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-value for non-fasting glucose change from baseline to endpoint.|ANOVA|Type II Sums of Squares from an analysis of variance (ANOVA) on the Ranks: Model = Pooled Investigator and Therapy.||||||0.030
71083714|NCT03442088|141673205|OTHER||Mean Difference (Final Values)|-0.272||||0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0001
71083715|NCT03442088|141673206|OTHER||Mean Difference (Final Values)|95.98||||0.934|TWO_SIDED|95.0|-2324.0|2516.0|||t-test, 2 sided|||||2516|-2324|0.934
71083716|NCT03442088|141673207|OTHER||Mean Difference (Final Values)|-0.6878||||0.1632|TWO_SIDED|95.0|-1.685|0.3097|||t-test, 2 sided|||||0.3097|-1.685|0.1632
71083717|NCT03442088|141673208|OTHER||Mean Difference (Final Values)|-2.344||||0.1063|TWO_SIDED|95.0|-5.248|0.5992|||t-test, 2 sided|||||0.5992|-5.248|0.1063
71083718|NCT03442088|141673209|OTHER||Mean Difference (Final Values)|3.24||||0.5611|TWO_SIDED|95.0|-8.333|14.81|||t-test, 2 sided|||||14.81|-8.333|0.5611
71083719|NCT00357877|141673214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25|STANDARD_ERROR_OF_MEAN|0.44||0.56|TWO_SIDED|95.0|-0.6|1.11||No interim analyses were done and no adjustment made for multiple comparisons. Identical analyses were run on each imputed dataset, with results combined with SAS® PROC MIANALZE to obtain final p-values.|Regression, Linear|The primary outcome analysis included treatment and site as class variables and age and age-squared as continuous covariates.||We hypothesized a lower increment score for the active treatment group but carried out two-tailed hypothesis testing. Sample size was estimated with simulated data with rank normalized scores. We calculated that 832 participants would yield a power of 90% to detect a 20% reduction in caries incidence (from a hypothesized mean increment of 1.5), and adopted a target of 1000 randomized participants to allow for attrition.||1.11|-0.60|0.56
71083720|NCT00357877|141673215|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.57||0.54|TWO_SIDED|95.0|-0.77|1.46||No adjustment for multiple comparisons. Identical analyses were run on each imputed dataset, with results combined with SAS® PROC MIANALYZE to obtain final p-values.|Regression, Linear|Model included treatment and site as class variables and age and age-squared as continuous covariates.||hypothesized a reduced caries increment in active arm, though conducted two-tailed hypothesis test.||1.46|-0.77|0.54
71083721|NCT00357877|141673216|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.38||0.18|TWO_SIDED|95.0|-1.25|0.23||No adjustment for multiple comparisons. Identical analyses were run on each imputed dataset, with results combined with SAS® PROC MIANALYZE to obtain final p-values.|Regression, Linear|treatment and site included as class variables and age and age-squared as continuous covariates.||Hypothesized lower increment in active arm, though hypothesis testing was two-sided.||0.23|-1.25|0.18
71122093|NCT00394901|141750190|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.82||||0.001||95.0|-1.3|-0.33|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.33|-1.30|0.001
71083722|NCT00357877|141673217|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.68|STANDARD_DEVIATION|0.57||0.24|TWO_SIDED|95.0|-1.8|0.45||No adjustment for multiple comparisons. Identical analyses were run on each imputed dataset, with results combined with SAS® PROC MIANALYZE to obtain final p-values.|Regression, Linear|Model included treatment and site as class variables, and age and age-squared as continuous covariates.||Hypothesized a lower increment for active treatment arm, although hypothesis testing was two-sided.||0.45|-1.80|0.24
71083723|NCT03570047|141673241|OTHER||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.558|0.766|||Cox proportional hazards model|||||0.766|0.558|<0.0001
71083724|NCT03570047|141673241|OTHER||Hazard Ratio (HR)|0.79||||0.0291|TWO_SIDED|95.0|0.642|0.977|||Cox proportional hazards model|||||0.977|0.642|0.0291
71083725|NCT03570047|141673241|OTHER||Hazard Ratio (HR)|0.71||||0.0001|TWO_SIDED|95.0|0.592|0.842|||Cox proportional hazards model|||||0.842|0.592|0.0001
71083726|NCT03570047|141673241|OTHER||Hazard Ratio (HR)|0.72||||0.0012|TWO_SIDED|95.0|0.591|0.879|||Cox proportional hazards model|||||0.879|0.591|0.0012
71083727|NCT03570047|141673242|OTHER||Hazard Ratio (HR)|0.72|||<|0.0001|TWO_SIDED|95.0|0.614|0.843|||Cox proportional hazards model|||||0.843|0.614|<0.0001
71083728|NCT03570047|141673242|OTHER||Hazard Ratio (HR)|0.66||||0.0003|TWO_SIDED|95.0|0.529|0.825|||Cox proportional hazards model|||||0.825|0.529|0.0003
71083729|NCT03570047|141673242|OTHER||Hazard Ratio (HR)|0.74||||0.0007|TWO_SIDED|95.0|0.618|0.879|||Cox proportional hazards model|||||0.879|0.618|0.0007
71083730|NCT03570047|141673242|OTHER||Hazard Ratio (HR)|0.71||||0.0011|TWO_SIDED|95.0|0.583|0.874|||Cox proportional hazards model|||||0.874|0.583|0.0011
71083731|NCT03570047|141673243|OTHER||Hazard Ratio (HR)|0.93||||0.0127|TWO_SIDED|95.0|0.872|0.984|||Cox proportional hazards model|||||0.984|0.872|0.0127
71122094|NCT00394901|141750190|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.62||||0.012||95.0|-1.09|-0.14|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.14|-1.09|0.012
70856160|NCT01340872|141199055|SUPERIORITY||Mean Difference (Final Values)|1.73|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|ONE_SIDED|97.5|1.43||||ANCOVA|||ANCOVA analysis of Change in Hb concentration from Baseline to Week 8 of double-blind phase - FAS, multiple imputation|||1.43|< 0.0001
70944481|NCT04159805|141389041|SUPERIORITY||Difference in LS Mean|4.93|||=|0.039|TWO_SIDED|95.0|0.26|9.6||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||9.60|0.26|=0.039
71083732|NCT03570047|141673243|OTHER||Hazard Ratio (HR)|0.96||||0.2893||95.0|0.881|1.039|||Cox proportional hazards model|||||1.039|0.881|0.2893
71083733|NCT03570047|141673243|OTHER||Hazard Ratio (HR)|0.94||||0.064|TWO_SIDED|95.0|0.881|1.004|||Cox proportional hazards model|||||1.004|0.881|0.0640
71083734|NCT03570047|141673243|OTHER||Hazard Ratio (HR)|1.03||||0.4404|TWO_SIDED|95.0|0.958|1.103|||Cox proportional hazards model|||||1.103|0.958|0.4404
71083735|NCT02820870|141673280|SUPERIORITY||Odds Ratio (OR)|3.0|||<|0.01|TWO_SIDED|95.0|1.84|4.9|||Regression, Logistic|With clustering by provider and team.||||4.9|1.84|<0.01
71122095|NCT02360293|141750209|SUPERIORITY||Slope|1.88|STANDARD_ERROR_OF_MEAN|46.2|||TWO_SIDED|95.0|-119.0|122.7|||||Generated through ANCOVA predicting Active Minutes as a function of arm and f/u time, adjusted for Sex, Baseline PA Goal (AM), and type of Smart Phone. Represents the contrast between SS+Coaching, 12 mos. - Baseline vs. SS alone, 12 mos. - Baseline.|Estimated marginal means/least squares means are derived from a linear mixed model/rmANOVA/rmANCOVA, adjusted for baseline AM goal, Type of Smart Phone, and Sex.||122.7|-119.0|
71122096|NCT02360293|141750210|SUPERIORITY||Slope|-5.02|STANDARD_ERROR_OF_MEAN|56.7|||TWO_SIDED|95.0|-15.85|5.81|||||Generated through ANCOVA predicting Weight as a function of the interaction of arm and follow-up time. Estimate represents the contrast between SS+Coaching, 12 mos. - Baseline vs. SS alone, 12 mos. - Baseline.|The estimated marginal means/least squares means are derived from a linear mixed model/rmANOVA/rmANCOVA.||5.81|-15.85|
71083736|NCT02820870|141673281|SUPERIORITY||Odds Ratio (OR)|1.65||||0.06|TWO_SIDED|95.0|0.99|2.77|||Regression, Logistic|With cluster by provider and team.||||2.77|0.99|0.06
71083737|NCT02754518|141673284|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|Paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||<0.001
71083738|NCT02754518|141673285|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||<0.001
71083739|NCT02754518|141673286|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||<0.001
70856161|NCT01340872|141199066|SUPERIORITY||Mean Difference (Final Values)|2.18|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|ONE_SIDED|97.5|1.87||||ANCOVA|||ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the PPAS|||1.87|< 0.0001
70856162|NCT01340872|141199067|SUPERIORITY||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|ONE_SIDED|97.5|1.82||||ANCOVA|||ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the FAS LOCF - Change in Haemoglobin Concentration from Baseline to Week 12|||1.82|< 0.0001
70856163|NCT03603509|141199077|SUPERIORITY|||||||0.062|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis: HAI Day 28 - HAI Day 0 for Fluad = HAI Day 28 - HAI Day 0 for Fluzone Alternative Hypothesis: HAI Day 28 - HAI Day 0 for Fluad NE HAI Day 28 - HAI Day 0 for Fluzone||||0.062
70856164|NCT03603509|141199086|SUPERIORITY|null hypothesis: CMV Fluad sample index = CMV Fluzone sample index at Baseline alternate hypothesis: CMV Fluad sample index not equal to CMV Fluzone sample index at Baseline||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
70944482|NCT04159805|141389041|SUPERIORITY||Difference in LS Mean|-0.22|||=|0.909|TWO_SIDED|95.0|-4.03|3.6||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||3.60|-4.03|=0.909
71083740|NCT02754518|141673287|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||<0.001
71083741|NCT02754518|141673288|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||<0.001
71083742|NCT02754518|141673289|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||<0.001
71083743|NCT02754518|141673290|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|Paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||<0.001
71083744|NCT02754518|141673291|OTHER|||||||0.13||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.|paired t-test|||0.13
71083745|NCT02754518|141673292|OTHER|||||||0.95||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|Paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||0.95
71083746|NCT02754518|141673293|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||<0.001
71083747|NCT02754518|141673294|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||<0.001
71083748|NCT02754518|141673295|OTHER|||||||0.65||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|Paired T-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||0.65
71083749|NCT02754518|141673296|OTHER|||||||0.06||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||0.06
71083750|NCT02754518|141673297|OTHER|||||||0.76||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.76
70856165|NCT04966910|141199104|SUPERIORITY|||||||0.036||||||This p-value applies to the time x condition interaction variable in a repeated-measure ANOVA for client data.|ANOVA|||Repeated measures ANOVA including a time x condition interaction term to test for differences in slopes by condition for client data.||||0.036
70856166|NCT04966910|141199105|SUPERIORITY|||||||0.226||||||This p-value refers to a time x condition interaction term in a repeated measures ANOVA.|ANOVA|||||||.226
70856167|NCT04966910|141199106|SUPERIORITY|||||||0.674||||||This p-value refers to a time x condition interaction term in a repeated measures ANOVA to test for differences in slopes over time.|ANOVA|||||||.674
71083751|NCT02754518|141673298|OTHER|||||||0.07||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Fisher Exact|||Primary outcome was presented at baseline and 1-year as frequency and percentages based upon the Shapiro-Wilks test of normality, and then analyzed with the Fisher exact test.||||0.07
71083752|NCT02754518|141673299|OTHER|||||||0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.001
70944483|NCT04159805|141389041|SUPERIORITY||Difference in LS Mean|2.65|||=|0.158|TWO_SIDED|95.0|-1.09|6.4||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||6.40|-1.09|=0.158
70944484|NCT04159805|141389041|SUPERIORITY||Difference in LS Mean|-0.88|||=|0.764|TWO_SIDED|95.0|-6.8|5.05||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||5.05|-6.80|=0.764
70944485|NCT04159805|141389041|SUPERIORITY||Difference in LS Mean|5.2|||=|0.08|TWO_SIDED|95.0|-0.67|11.06||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||11.06|-0.67|=0.080
70944486|NCT04159805|141389041|SUPERIORITY||Difference in LS Mean|-1.01|||=|0.677|TWO_SIDED|95.0|-5.98|3.95||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||3.95|-5.98|=0.677
70944487|NCT04159805|141389041|SUPERIORITY||Difference in LS Mean|4.81|||=|0.055|TWO_SIDED|95.0|-0.1|9.73||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||9.73|-0.10|=0.055
70944488|NCT04159805|141389042|SUPERIORITY||Difference in LS Mean|0.52|||=|0.78|TWO_SIDED|95.0|-3.23|4.27||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||4.27|-3.23|=0.780
70944489|NCT04159805|141389042|SUPERIORITY||Difference in LS Mean|0.5|||=|0.771|TWO_SIDED|95.0|-2.99|3.99||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||3.99|-2.99|=0.771
70944490|NCT04159805|141389042|SUPERIORITY||Difference in LS Mean|-0.04|||=|0.984|TWO_SIDED|95.0|-4.22|4.14||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||4.14|-4.22|=0.984
70944491|NCT04159805|141389042|SUPERIORITY||Difference in LS Mean|2.44|||=|0.213|TWO_SIDED|95.0|-1.47|6.35||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||6.35|-1.47|=0.213
71122097|NCT02360293|141750211|SUPERIORITY||Slope|-1.162|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-2.969|0.646|||||Generated through ANCOVA predicting PHQ-8 Score as a function of the interaction of arm and follow-up time. Estimate represents the contrast between SS+Coaching, 12 mos. - Baseline vs. SS alone, 12 mos. - Baseline.|The estimated marginal means/least squares means are derived from a linear mixed model/rmANOVA/rmANCOVA.||0.646|-2.969|
71122098|NCT02360293|141750212|SUPERIORITY||Slope|-0.345|STANDARD_ERROR_OF_MEAN|0.267|||TWO_SIDED|95.0|-1.044|0.353|||||"Estimate generated through ANCOVA predicting Pain In Past Week as a function of the interaction of arm and follow-up time. Estimate represents the contrast between SS+Coaching, 12 mos. - Baseline vs. SS alone, 12 mos. - Baseline.."|The estimated marginal means/least squares means are derived from a linear mixed model/rmANOVA/rmANCOVA.||0.353|-1.044|
71122099|NCT00316524|141750230|NON_INFERIORITY|The non-inferiority margin to show that Group 4 (vaccinia experienced subjects receiving a single vaccination) is non-inferior to Group 1 (vaccinia naive subjects receiving 2 vaccinations) in terms of seroconversion rate 2 weeks after the last vaccination was predefined as -5% for the difference in seroconversion rates|Difference in seroconversion rates (%)|-3.4|||||ONE_SIDED|97.5|-7.36||||||||||-7.36|
70944492|NCT04159805|141389042|SUPERIORITY||Difference in LS Mean|-1.97|||=|0.371|TWO_SIDED|95.0|-6.4|2.45||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||2.45|-6.40|=0.371
70944493|NCT04159805|141389042|SUPERIORITY||Difference in LS Mean|0.11|||=|0.956|TWO_SIDED|95.0|-4.01|4.23||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||4.23|-4.01|=0.956
71122100|NCT03654885|141750243|NON_INFERIORITY|By assuming the margin of non-inferiority at 24%, the null hypothesis for this non-inferiority testing was to be set up as XEN implanted group (P1)-Trabeculectomy group (P2) ≤-0.24 versus the alternative hypothesis as P1-P2 \>-0.24. Equivalently, non-inferiority of P1 to P2 was to be declared if the lower limit of the 2-sided confidence interval (CI) of the difference of the above endpoint between the two treatment groups computed using normal approximation was found to be greater than -24%.|Percentage Difference|-6.1||||0.487|TWO_SIDED|95.0|-22.9|10.8|||Chi-squared|||||10.8|-22.9|0.487
71083753|NCT02754518|141673302|OTHER|||||||0.03||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.03
71083754|NCT02754518|141673303|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|Paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||<0.001
71083755|NCT02754518|141673304|OTHER|||||||0.02||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.02
70856168|NCT04966910|141199107|SUPERIORITY|||||||0.317||||||This p-value refers to a time x condition interaction term in a repeated measures ANOVA to test for differences in slopes over time.|ANOVA|||||||.317
71083756|NCT02754518|141673305|OTHER||||||<|0.001||||||P-Values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|Paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||<0.001
71083757|NCT02754518|141673306|OTHER|||||||0.82||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.82
71083758|NCT02754518|141673307|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||<0.001
71083759|NCT02754518|141673308|OTHER|||||||0.01||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.01
71083760|NCT02754518|141673309|OTHER|||||||0.11||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.11
71083761|NCT02754518|141673310|OTHER|||||||0.17||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.17
71083762|NCT02754518|141673311|OTHER|||||||0.035||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.035
71083763|NCT02754518|141673312|OTHER|||||||0.059||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.059
71122101|NCT03654885|141750245|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-5.81|STANDARD_ERROR_OF_MEAN|1.155|<|0.001|TWO_SIDED|95.0|-8.074|-3.538||Mixed Model for Repeated Measures (MMRM) model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Day 1||-3.538|-8.074|<0.001
71122102|NCT03654885|141750245|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-0.22|STANDARD_ERROR_OF_MEAN|1.163||0.851|TWO_SIDED|95.0|-2.503|2.066||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Week 1||2.066|-2.503|0.851
71083764|NCT02754518|141673313|OTHER|||||||0.054||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.054
71083765|NCT02754518|141673314|OTHER|||||||0.28||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.28
71083766|NCT02754518|141673315|OTHER|||||||0.002||||||P-Values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.002
70944494|NCT04159805|141389042|SUPERIORITY||Difference in LS Mean|-1.06|||=|0.641|TWO_SIDED|95.0|-5.65|3.53||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||3.53|-5.65|=0.641
70944495|NCT04159805|141389042|SUPERIORITY||Difference in LS Mean|-0.33|||=|0.876|TWO_SIDED|95.0|-4.61|3.95||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||3.95|-4.61|=0.876
71083767|NCT02754518|141673316|OTHER|||||||0.008||||||P-Values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.008
70944496|NCT04159805|141389042|SUPERIORITY||Difference in LS Mean|-1.86|||=|0.458|TWO_SIDED|95.0|-6.91|3.18||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||3.18|-6.91|=0.458
71083768|NCT02754518|141673317|OTHER|||||||0.005||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.005
71083769|NCT02754518|141673318|OTHER|||||||0.056||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.056
71083770|NCT03318003|141673320|SUPERIORITY||Pearson Chi Square|0.76||||0.92|TWO_SIDED|||||no adjustments made|Chi-squared|||||||0.92
71083771|NCT02427841|141673376|SUPERIORITY|Tested against the standard R0 rate of 37%. Given all evaluable patients are included in the denominator, R0 of 56% was not achieved. Specifically, of the 19 evaluable patients, 11 proceeded to surgery. Of the 11 who underwent surgery, 8 \[42% of those enrolled, but 72.7% of those resected\] achieved R0 resection.|binomial|42.0||||0.404|TWO_SIDED|95.0|20.0|67.0||Study was underpowered.|2-sided exact binomial||Test for superiority over standard R0 resection rate of 37%. Study was closed due to slow enrollment, meaning the primary endpoint was underpowered with only 19 of an expected 44 patients enrolled.|Study closed early due to lack of enrollment. Study expected to enrolled 44 evaluable patients to achieve 83% power using the 2-sided binomial test at 10% significance. Study enrolled only 19 evaluable patients, meaning the study was underpowered at \< 62%||67|20|.404
71083772|NCT00905424|141673413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.3||||0.0902|TWO_SIDED|90.0|-4.5|-0.1||The test was performed a priori at the significance level of 0.10|ANCOVA|||||-0.1|-4.5|0.0902
71083773|NCT00905424|141673414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.3091|TWO_SIDED|90.0|-2.4|0.6||The test was performed a priori at the significance level of 0.10|ANCOVA|||||0.6|-2.4|0.3091
71083774|NCT00905424|141673415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.0573|TWO_SIDED|90.0|-3.7|-0.3||The test was performed a priori at the significance level of 0.10|ANCOVA|||||-0.3|-3.7|0.0573
71083775|NCT00905424|141673416|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2368||95.0|||||Cochran-Mantel-Haenszel|||||||0.2368
71083776|NCT00905424|141673419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.0||||0.0463|TWO_SIDED|90.0|-5.4|-0.5||The test was performed a priori at the significance level of 0.10|ANCOVA|||Global Executive Composite||-0.5|-5.4|0.0463
70944497|NCT04159805|141389042|SUPERIORITY||Difference in LS Mean|-0.68|||=|0.769|TWO_SIDED|95.0|-5.37|4.0||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||4.00|-5.37|=0.769
71083777|NCT00905424|141673419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.1431|TWO_SIDED|90.0|-4.3|0.3||The test was performed a priori at the significance level of 0.10|ANCOVA|||Behavioral Regulation Index||0.3|-4.3|0.1431
71083778|NCT00905424|141673419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3||||0.0281|TWO_SIDED|90.0|-5.8|-0.8||The test was performed a priori at the significance level of 0.10|ANCOVA|||Metacognition Index||-0.8|-5.8|0.0281
71083779|NCT00905424|141673420|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.0||||0.092|TWO_SIDED|90.0|-6.0|-0.1||The test was performed a priori at the significance level of 0.10|ANCOVA|||||-0.1|-6.0|0.0920
71083780|NCT00905424|141673421|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0774|TWO_SIDED|90.0|-2.2|-0.1||The test was performed a priori at the significance level of 0.10|ANCOVA|||||-0.1|-2.2|0.0774
71083781|NCT00905424|141673422|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.2||||0.4726|TWO_SIDED|90.0|-1.6|4.0||The test was performed a priori at the significance level of 0.10|ANCOVA|||||4.0|-1.6|0.4726
71083782|NCT00905424|141673423|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.5182|TWO_SIDED|90.0|-1.4|3.1||The test was performed a priori at the significance level of 0.10|ANCOVA|||||3.1|-1.4|0.5182
71083783|NCT00905424|141673424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.463|TWO_SIDED|90.0|-3.1|1.2||The test was performed a priori at the significance level of 0.10|ANCOVA|||||1.2|-3.1|0.4630
71083784|NCT00905424|141673425|SUPERIORITY_OR_OTHER_LEGACY|||||||0.523||95.0|||||Cochran-Mantel-Haenszel|||||||0.5230
70944498|NCT04159805|141389042|SUPERIORITY||Difference in LS Mean|-1.14|||=|0.699|TWO_SIDED|95.0|-7.07|4.8||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||4.80|-7.07|=0.699
70944499|NCT04159805|141389042|SUPERIORITY||Difference in LS Mean|1.1|||=|0.687|TWO_SIDED|95.0|-4.41|6.62||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||6.62|-4.41|=0.687
71083785|NCT00905424|141673428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.8||||0.2876|TWO_SIDED|90.0|-1.0|4.7||The test was performed a priori at the significance level of 0.10|ANCOVA|||Global Executive Composite||4.7|-1.0|0.2876
71083786|NCT00905424|141673428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1||||0.559|TWO_SIDED|90.0|-2.1|4.4||The test was performed a priori at the significance level of 0.10|ANCOVA|||Behavioral Regulation Index||4.4|-2.1|0.5590
71083787|NCT00905424|141673428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.3||||0.2079|TWO_SIDED|90.0|-0.7|5.2||The test was performed a priori at the significance level of 0.10|ANCOVA|||Metacognition Index||5.2|-0.7|0.2079
71083788|NCT00905424|141673429|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.7||||0.1489|TWO_SIDED|90.0|-8.0|0.5||The test was performed a priori at the significance level of 0.10|ANCOVA|||||0.5|-8.0|0.1489
71083789|NCT00905424|141673430|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.0852|TWO_SIDED|90.0|-2.8|-0.1||The test was performed a priori at the significance level of 0.10|ANCOVA|||||-0.1|-2.8|0.0852
71083790|NCT03804268|141673450|SUPERIORITY||Percentage Difference|22.5|||<|0.0001|TWO_SIDED|95.0|14.3|30.8||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. 95% confidence interval for the percentage differences was calculated based on the normal approximation based on pooled variance without continuity correction.|||30.8|14.3|<0.0001
71083791|NCT03804268|141673451|SUPERIORITY||Percentage Difference|9.7||||0.0114|TWO_SIDED|95.0|2.3|17.0||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. 95% confidence interval for the percentage differences was calculated based on the normal approximation based on pooled variance without continuity correction.|||17.0|2.3|0.0114
71083792|NCT03804268|141673452|SUPERIORITY||Percentage Difference|2.1||||1|TWO_SIDED|95.0|-4.4|8.5||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. 95% confidence interval for the percentage differences was calculated based on the normal approximation based on pooled variance without continuity correction.|||8.5|-4.4|1.0000
71083793|NCT03804268|141673453|SUPERIORITY||Least Square (LS) Mean Difference|5.1|STANDARD_ERROR_OF_MEAN|0.72||0.0114|TWO_SIDED|95.0|3.7|6.5||MMRM with fixed effects: study intervention group,visit,visit by study intervention group interaction,age group,Baseline binocular DCNVA severity,iris color,emmetrope/non-emmetrope, Baseline value, and Baseline value by visit interaction was used.|MMRM|P-value was adjusted for multiplicity control.||||6.5|3.7|0.0114
71083794|NCT03804268|141673454|SUPERIORITY||Percentage Difference|18.7||||0.0114|TWO_SIDED|95.0|10.6|26.7||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. 95% confidence interval was calculated based on normal approximation based on pooled variance without continuity correction.|||26.7|10.6|0.0114
71083795|NCT03804268|141673455|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.14||0.0114|TWO_SIDED|95.0|0.6|1.1||Analysis of covariance (ANCOVA) was used with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||1.1|0.6|0.0114
71083796|NCT03804268|141673456|SUPERIORITY||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|0.55||0.0114|TWO_SIDED|95.0|2.4|4.6||MMRM with fixed effects: study intervention group,visit,visit by study intervention group interaction,age group,Baseline binocular DCNVA severity,iris color,emmetrope/non-emmetrope, Baseline value, and Baseline value by visit interaction was used.|MMRM|P-value was adjusted for multiplicity control.||||4.6|2.4|0.0114
71083797|NCT03804268|141673457|SUPERIORITY||Percentage Difference|-1.1||||1|TWO_SIDED|95.0|-7.1|5.0||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. 95% confidence interval for the percentage differences was calculated based on the normal approximation based on pooled variance without continuity correction.|||5.0|-7.1|1.0000
71083798|NCT03804268|141673458|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|0.66||0.0114|TWO_SIDED|95.0|1.3|3.9||MMRM with fixed effects: study intervention group,visit,visit by study intervention group interaction,age group,Baseline binocular DCNVA severity,iris color,emmetrope/non-emmetrope, Baseline value, and Baseline value by visit interaction was used.|MMRM|P-value was adjusted for multiplicity control.||||3.9|1.3|0.0114
71083799|NCT03804268|141673459|SUPERIORITY||Percentage Difference|12.6||||0.0171|TWO_SIDED|95.0|3.5|21.6||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. 95% confidence interval for the percentage differences was calculated based on the normal approximation based on pooled variance without continuity correction.|||21.6|3.5|0.0171
71083800|NCT03804268|141673460|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.13||0.0114|TWO_SIDED|95.0|0.5|1.1||ANCOVA was used with study intervention group, age group, baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||1.1|0.5|0.0114
71083801|NCT03804268|141673461|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.09||0.0114|TWO_SIDED|95.0|-0.6|-0.3||ANCOVA was used with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||-0.3|-0.6|0.0114
70944500|NCT04159805|141389042|SUPERIORITY||Difference in LS Mean|0.2|||=|0.944|TWO_SIDED|95.0|-5.55|5.95||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||5.95|-5.55|=0.944
71083802|NCT03804268|141673462|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.08||0.0114|TWO_SIDED|95.0|-0.4|-0.1||ANCOVA was used with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||-0.1|-0.4|0.0114
71083803|NCT01156805|141673467|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|Mixed-effects linear regression, adjusted for clustering within schools and children to assess the effect of intervention on changes in BMI over time||||||0.05
71083804|NCT01843803|141673471|SUPERIORITY||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|1.5||0.029|TWO_SIDED|||||"P-Value = 0.029 after adjusting for clinical and demographic, and accounting for clustering of patients within providers.~Comparison of adjusted CARES score yielded a significant difference."|Mixed Models Analysis|A mixed model was ran with CARES as the dependent variable, adjusted for demographic and clinical measures , and provider as a random effect.||Mixed model adjusted for gender, race, education, marital status, mental health condition, substance disorder, COPD, heart failure, diabetes, coronary artery disease, study site and accounting for clustering of patients within providers.||||0.029
71122103|NCT03654885|141750245|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|2.03|STANDARD_ERROR_OF_MEAN|1.162||0.081|TWO_SIDED|95.0|-0.253|4.309||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Week 2||4.309|-0.253|0.081
71083805|NCT01843803|141673473|SUPERIORITY||Odds Ratio (OR)|1.69||||0.065|TWO_SIDED|95.0|0.99|2.86||P-Value derived after adjusting model provider clustering and treating it as a random effect.|Mixed Models Analysis|||Assessed whether a person in the intervention group vs the attention control group was more likely to be probed at least once by their provider after adjusting for other measures and accounting for the provider clustering.||2.86|0.99|.065
71083806|NCT01843803|141673474|SUPERIORITY||||||<|0.05|||||||Chi-squared|||chi-square||||<0.05
71083807|NCT03311841|141673475|OTHER||Geometric least squares mean ratio|0.64|||||TWO_SIDED|95.0|0.37|1.11|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.11|0.37|
71122104|NCT03654885|141750245|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|2.21|STANDARD_ERROR_OF_MEAN|1.157||0.056|TWO_SIDED|95.0|-0.059|4.484||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Month 1||4.484|-0.059|0.056
71122105|NCT03654885|141750245|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|4.74|STANDARD_ERROR_OF_MEAN|1.181|<|0.001|TWO_SIDED|95.0|2.416|7.054||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Month 3||7.054|2.416|<0.001
71122106|NCT03654885|141750245|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|3.01|STANDARD_ERROR_OF_MEAN|1.197||0.012|TWO_SIDED|95.0|0.657|5.358||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Month 6||5.358|0.657|0.012
71122107|NCT03654885|141750245|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|3.53|STANDARD_ERROR_OF_MEAN|1.197||0.003|TWO_SIDED|95.0|1.182|5.883||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Month 9||5.883|1.182|0.003
71122108|NCT03654885|141750245|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|2.77|STANDARD_ERROR_OF_MEAN|1.229||0.024|TWO_SIDED|95.0|0.358|5.183||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Month 12||5.183|0.358|0.024
71122109|NCT03654885|141750247|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.505|TWO_SIDED|95.0|-0.36|0.18||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Day 1||0.18|-0.36|0.505
71122110|NCT03654885|141750247|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.949|TWO_SIDED|95.0|-0.28|0.26||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Week 1||0.26|-0.28|0.949
71122111|NCT03654885|141750247|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.581|TWO_SIDED|95.0|-0.19|0.34||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Week 2||0.34|-0.19|0.581
71122112|NCT03654885|141750247|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.302|TWO_SIDED|95.0|-0.13|0.41||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 1||0.41|-0.13|0.302
70944501|NCT04159805|141389042|SUPERIORITY||Difference in LS Mean|2.48|||=|0.351|TWO_SIDED|95.0|-2.87|7.83||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||7.83|-2.87|=0.351
70944502|NCT04159805|141389043|SUPERIORITY||Difference in LS Mean|-27.9|||=|0.09|TWO_SIDED|95.0|-60.18|4.38||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 2||4.38|-60.18|=0.090
70944503|NCT04159805|141389043|SUPERIORITY||Difference in LS Mean|-15.77|||=|0.328|TWO_SIDED|95.0|-47.5|15.96||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 2||15.96|-47.50|=0.328
70944504|NCT04159805|141389043|SUPERIORITY||Difference in LS Mean|-12.65|||=|0.441|TWO_SIDED|95.0|-44.94|19.63||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 3||19.63|-44.94|=0.441
71083808|NCT03311841|141673475|OTHER|Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Geometric least squares mean ratio|1.33|||||TWO_SIDED|95.0|0.77|2.31||||||Comparison of midazolam||2.31|0.77|
71083809|NCT03311841|141673475|OTHER|Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Geometric least squares mean ratio|0.95|||||TWO_SIDED|95.0|0.56|1.62||||||Comparison of midazolam||1.62|0.56|
71083810|NCT03311841|141673475|OTHER||Geometric least squares mean ratio|0.4|||||TWO_SIDED|95.0|0.23|0.7|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||0.70|0.23|
71083811|NCT03311841|141673475|OTHER||Geometric least squares mean ratio|1.01|||||TWO_SIDED|95.0|0.53|1.93|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||1.93|0.53|
71083812|NCT03311841|141673475|OTHER||Geometric least squares mean ratio|2.87|||||TWO_SIDED|95.0|1.51|5.47|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||5.47|1.51|
71083813|NCT03311841|141673475|OTHER||Geometric least squares mean ratio|4.98|||||TWO_SIDED|95.0|2.62|9.48|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||9.48|2.62|
71083814|NCT03311841|141673475|OTHER||Geometric least squares mean ratio|3.39|||||TWO_SIDED|95.0|1.78|6.44|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||6.44|1.78|
71083815|NCT03311841|141673475|OTHER|Comparison of pitavastatin|Geometric least squares mean ratio|1.32|||||TWO_SIDED|95.0|0.76|2.31|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||2.31|0.76|
71083816|NCT03311841|141673475|OTHER||Geometric least squares mean ratio|1.96|||||TWO_SIDED|95.0|1.12|3.42|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||3.42|1.12|
71083817|NCT03311841|141673475|OTHER||Geometric least squares mean ratio|1.25|||||TWO_SIDED|95.0|0.73|2.13|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.13|0.73|
71083818|NCT03311841|141673475|OTHER||Geometric least squares mean ratio|1.3|||||TWO_SIDED|95.0|0.74|2.27|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.27|0.74|
71083819|NCT03311841|141673475|OTHER||Geometric least squares mean ratio|1.05|||||TWO_SIDED|95.0|0.64|1.72|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.72|0.64|
70856169|NCT04966910|141199108|SUPERIORITY|||||||0.741||||||This p-value refers to a time x condition interaction term in a repeated measures ANOVA to test for differences in slopes over time.|ANOVA|||||||.741
70856170|NCT04966910|141199109|SUPERIORITY|||||||0.737||||||This p-value refers to a time x condition interaction term in a repeated measures ANOVA to test for differences in slopes over time.|ANOVA|||||||.737
71083820|NCT03311841|141673475|OTHER||Geometric least squares mean ratio|1.45|||||TWO_SIDED|95.0|0.88|2.38|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||2.38|0.88|
71083821|NCT03311841|141673475|OTHER|Comparison of pitavastatin lactone|Geometric least squares mean ratio|1.09|||||TWO_SIDED|95.0|0.68|1.76|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||1.76|0.68|
71083822|NCT03311841|141673475|OTHER|Comparison of pitavastatin lactone|Geometric least squares mean ratio|0.71|||||TWO_SIDED|95.0|0.43|1.17|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||1.17|0.43|
71083823|NCT03311841|141673475|OTHER|Comparison of atorvastatin|Geometric least squares mean ratio|1.13|||||TWO_SIDED|95.0|0.53|2.41|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||2.41|0.53|
71083824|NCT03311841|141673475|OTHER|Comparison of atorvastatin|Geometric least squares mean ratio|1.75|||||TWO_SIDED|95.0|0.89|3.46|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||3.46|0.89|
71083825|NCT03311841|141673475|OTHER||Geometric least squares mean ratio|1.63|||||TWO_SIDED|95.0|0.85|3.14|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||3.14|0.85|
71083826|NCT03311841|141673475|OTHER|Comparison of atorvastatin|Geometric least squares mean ratio|1.13|||||TWO_SIDED|95.0|0.57|2.22|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||2.22|0.57|
71083827|NCT03311841|141673475|OTHER|Comparison of ortho-hydroxyatorvastatin|Geometric least squares mean ratio|1.38|||||TWO_SIDED|95.0|0.76|2.49|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||2.49|0.76|
71083828|NCT03311841|141673475|OTHER|Comparison of ortho-hydroxyatorvastatin|Geometric least squares mean ratio|1.31|||||TWO_SIDED|95.0|0.75|2.29|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||2.29|0.75|
71083829|NCT03311841|141673475|OTHER|Comparison of ortho-hydroxyatorvastatin|Geometric least squares mean ratio|1.09|||||TWO_SIDED|95.0|0.65|1.81|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||1.81|0.65|
71083830|NCT03311841|141673475|OTHER|Comparison of ortho-hydroxyatorvastatin|Geometric least squares mean ratio|0.79|||||TWO_SIDED|95.0|0.46|1.33|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||1.33|0.46|
71083831|NCT03311841|141673475|OTHER|Comparison of rosuvastatin|Geometric least squares mean ratio|0.9|||||TWO_SIDED|95.0|0.33|2.45|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||2.45|0.33|
71083832|NCT03311841|141673475|OTHER|Comparison of rosuvastatin|Geometric least squares mean ratio|1.97|||||TWO_SIDED|95.0|0.75|5.14|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||5.14|0.75|
71083833|NCT03311841|141673475|OTHER|Comparison of rosuvastatin|Geometric least squares mean ratio|1.25|||||TWO_SIDED|95.0|0.49|3.16|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||3.16|0.49|
71083834|NCT03311841|141673475|OTHER|Comparison of rosuvastatin|Geometric least squares mean ratio|0.71|||||TWO_SIDED|95.0|0.27|1.86|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||1.86|0.27|
71083835|NCT03311841|141673477|OTHER||Geometric least squares mean ratio|0.67|||||TWO_SIDED|95.0|0.4|1.11|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.11|0.40|
71083836|NCT03311841|141673477|OTHER||Geometric least squares mean ratio|1.26|||||TWO_SIDED|95.0|0.76|2.09|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||2.09|0.76|
71083837|NCT03311841|141673477|OTHER||Geometric least squares mean ratio|0.93|||||TWO_SIDED|95.0|0.57|1.52|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.52|0.57|
71083838|NCT03311841|141673477|OTHER||Geometric least squares mean ratio|0.42|||||TWO_SIDED|95.0|0.25|0.7|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||0.70|0.25|
71083839|NCT03311841|141673477|OTHER||Geometric least squares mean ratio|0.96|||||TWO_SIDED|95.0|0.53|1.73|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||1.73|0.53|
71083840|NCT03311841|141673477|OTHER||Geometric least squares mean ratio|2.38|||||TWO_SIDED|95.0|1.32|4.32|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||4.32|1.32|
70944505|NCT04159805|141389043|SUPERIORITY||Difference in LS Mean|1.39|||=|0.931|TWO_SIDED|95.0|-30.33|33.12||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 3||33.12|-30.33|=0.931
71083841|NCT03311841|141673477|OTHER||Geometric least squares mean ratio|3.09|||||TWO_SIDED|95.0|1.75|5.48|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||5.48|1.75|
70856171|NCT00830791|141199131|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.74||||0.325|TWO_SIDED|90.0|0.43|1.26|||ANCOVA||The mean square error on a log scale for this comparison was 0.322.|||1.26|0.43|0.325
71083842|NCT03311841|141673477|OTHER||Geometric least squares mean ratio|1.46|||||TWO_SIDED|95.0|0.8|2.64|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||2.64|0.80|
71083843|NCT03311841|141673477|OTHER||Geometric least squares mean ratio|1.31|||||TWO_SIDED|95.0|0.78|2.2|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.20|0.78|
71083844|NCT03311841|141673477|OTHER||Geometric least squares mean ratio|1.84|||||TWO_SIDED|95.0|1.09|3.09|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||3.09|1.09|
71083845|NCT03311841|141673477|OTHER||Geometric least squares mean ratio|1.26|||||TWO_SIDED|95.0|0.77|2.09|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.09|0.77|
71083846|NCT03311841|141673477|OTHER||Geometric least squares mean ratio|1.43|||||TWO_SIDED|95.0|0.85|2.4|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.40|0.85|
71083847|NCT03311841|141673477|OTHER||Geometric least squares mean ratio|1.03|||||TWO_SIDED|95.0|0.68|1.56|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.56|0.68|
71083848|NCT03311841|141673477|OTHER||Geometric least squares mean ratio|1.27|||||TWO_SIDED|95.0|0.83|1.92|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.92|0.83|
71083849|NCT03311841|141673477|OTHER||Geometric least squares mean ratio|1.09|||||TWO_SIDED|95.0|0.73|1.63|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.63|0.73|
71083850|NCT03311841|141673477|OTHER||Geometric least squares mean ratio|0.85|||||TWO_SIDED|95.0|0.56|1.29|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.29|0.56|
71083851|NCT03311841|141673477|OTHER||Geometric least squares mean ratio|1.11|||||TWO_SIDED|95.0|0.55|2.23|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||2.23|0.55|
71083852|NCT03311841|141673477|OTHER||Geometric least squares mean ratio|1.66|||||TWO_SIDED|95.0|0.89|3.11|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||3.11|0.89|
71083853|NCT03311841|141673477|OTHER||Geometric least squares mean ratio|1.52|||||TWO_SIDED|95.0|0.83|2.77|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||2.77|0.83|
71083854|NCT03311841|141673477|OTHER||Geometric least squares mean ratio|1.45|||||TWO_SIDED|95.0|0.78|2.71|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||2.71|0.78|
71083855|NCT03311841|141673477|OTHER||Geometric least squares mean ratio|1.28|||||TWO_SIDED|95.0|0.7|2.34|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.34|0.70|
71083856|NCT03311841|141673477|OTHER||Geometric least squares mean ratio|1.33|||||TWO_SIDED|95.0|0.78|2.28|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.28|0.78|
71083857|NCT03311841|141673477|OTHER||Geometric least squares mean ratio|1.03|||||TWO_SIDED|95.0|0.62|1.74|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||1.74|0.62|
70944506|NCT04159805|141389043|SUPERIORITY||Difference in LS Mean|-28.18|||=|0.087|TWO_SIDED|95.0|-60.46|4.11||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||4.11|-60.46|=0.087
71083858|NCT03311841|141673477|OTHER||Geometric least squares mean ratio|1.06|||||TWO_SIDED|95.0|0.62|1.82|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||1.82|0.62|
71083859|NCT03311841|141673477|OTHER||Geometric least squares mean ratio|1.25|||||TWO_SIDED|95.0|0.58|2.67|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.67|0.58|
71083860|NCT03311841|141673477|OTHER||Geometric least squares mean ratio|2.25|||||TWO_SIDED|95.0|1.09|4.63|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||4.63|1.09|
71083861|NCT03311841|141673477|OTHER||Geometric least squares mean ratio|1.46|||||TWO_SIDED|95.0|0.72|2.93|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.93|0.72|
71083862|NCT03311841|141673477|OTHER||Geometric least squares mean ratio|1.06|||||TWO_SIDED|95.0|0.51|2.19|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.19|0.51|
71083863|NCT03311841|141673478|OTHER||Geometric least squares mean ratio|0.63|||||TWO_SIDED|95.0|0.36|1.11|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.11|0.36|
71083864|NCT03311841|141673478|OTHER||Geometric least squares mean ratio|1.3|||||TWO_SIDED|95.0|0.75|2.28|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||2.28|0.75|
71083865|NCT03311841|141673478|OTHER||Geometric least squares mean ratio|0.94|||||TWO_SIDED|95.0|0.55|1.61|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.61|0.55|
71083866|NCT03311841|141673478|OTHER||Geometric least squares mean ratio|0.4|||||TWO_SIDED|95.0|0.23|0.69|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||0.69|0.23|
71083867|NCT03311841|141673478|OTHER||Geometric least squares mean ratio|1.02|||||TWO_SIDED|95.0|0.53|1.95|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||1.95|0.53|
71083868|NCT03311841|141673478|OTHER||Geometric least squares mean ratio|3.0|||||TWO_SIDED|95.0|1.57|5.74|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||5.74|1.57|
71083869|NCT03311841|141673478|OTHER||Geometric least squares mean ratio|5.28|||||TWO_SIDED|95.0|2.83|9.87|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||9.87|2.83|
71083870|NCT03311841|141673478|OTHER||Geometric least squares mean ratio|2.65|||||TWO_SIDED|95.0|1.39|5.07|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||5.07|1.39|
71083871|NCT03311841|141673478|OTHER||Geometric least squares mean ratio|1.33|||||TWO_SIDED|95.0|0.76|2.34|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.34|0.76|
71083872|NCT03311841|141673478|OTHER||Geometric least squares mean ratio|1.97|||||TWO_SIDED|95.0|1.12|3.46|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||3.46|1.12|
71083873|NCT03311841|141673478|OTHER||Geometric least squares mean ratio|1.25|||||TWO_SIDED|95.0|0.72|2.15|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.15|0.72|
71083874|NCT03311841|141673478|OTHER||Geometric least squares mean ratio|1.34|||||TWO_SIDED|95.0|0.76|2.36|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.36|0.76|
71083875|NCT03311841|141673478|OTHER||Geometric least squares mean ratio|1.03|||||TWO_SIDED|95.0|0.64|1.65|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.65|0.64|
71083876|NCT03311841|141673478|OTHER||Geometric least squares mean ratio|1.39|||||TWO_SIDED|95.0|0.87|2.24|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||2.24|0.87|
70856172|NCT00830791|141199132|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.95||||0.718|TWO_SIDED|90.0|0.76|1.2|||ANCOVA||The mean square error on a log scale was 0.061 for this comparison.|||1.20|0.76|0.718
71083877|NCT03311841|141673478|OTHER||Geometric least squares mean ratio|1.08|||||TWO_SIDED|95.0|0.68|1.71|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.71|0.68|
71083878|NCT03311841|141673478|OTHER||Geometric least squares mean ratio|0.73|||||TWO_SIDED|95.0|0.45|1.17|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.17|0.45|
71083879|NCT03311841|141673478|OTHER||Geometric least squares mean ratio|1.16|||||TWO_SIDED|95.0|0.53|2.52|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||2.52|0.53|
70856173|NCT00830791|141199133|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.63||||0.014|TWO_SIDED|90.0|1.21|2.2|||ANCOVA||The mean square error on a log scale was 0.104 for this comparison.|||2.20|1.21|0.014
70944507|NCT04159805|141389043|SUPERIORITY||Difference in LS Mean|4.44|||=|0.783|TWO_SIDED|95.0|-27.29|36.16||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||36.16|-27.29|=0.783
70856174|NCT00830791|141199135|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.14||||0.505|TWO_SIDED|90.0|0.81|1.6|||ANCOVA||The mean square error on a log scale for this comparison was 0.133.|||1.60|0.81|0.505
70856175|NCT00830791|141199137|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.0|||||TWO_SIDED|90.0|0.0|0.5|||ANCOVA|||||0.50|0.00|
70856176|NCT00830791|141199138|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.0|||||TWO_SIDED|90.0|0.0|0.5|||ANCOVA|||||0.50|0.00|
71083880|NCT03311841|141673478|OTHER||Geometric least squares mean ratio|1.8|||||TWO_SIDED|95.0|0.9|3.62|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||3.62|0.90|
71083881|NCT03311841|141673478|OTHER||Geometric least squares mean ratio|1.65|||||TWO_SIDED|95.0|0.84|3.23|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||3.23|0.84|
71083882|NCT03311841|141673478|OTHER||Geometric least squares mean ratio|1.17|||||TWO_SIDED|95.0|0.58|2.35|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||2.35|0.58|
71083883|NCT03311841|141673478|OTHER||Geometric least squares mean ratio|1.46|||||TWO_SIDED|95.0|0.71|2.97|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.97|0.71|
71083884|NCT03311841|141673478|OTHER||Geometric least squares mean ratio|1.68|||||TWO_SIDED|95.0|0.89|3.19|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||3.19|0.89|
71083885|NCT03311841|141673478|OTHER||Geometric least squares mean ratio|1.16|||||TWO_SIDED|95.0|0.63|2.14|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.14|0.63|
71083886|NCT03311841|141673478|OTHER||Geometric least squares mean ratio|0.83|||||TWO_SIDED|95.0|0.44|1.57|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||1.57|0.44|
71122113|NCT03654885|141750247|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.4|STANDARD_ERROR_OF_MEAN|0.14||0.005|TWO_SIDED|95.0|0.12|0.66||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 3||0.66|0.12|0.005
71083887|NCT03311841|141673478|OTHER||Geometric least squares mean ratio|1.27|||||TWO_SIDED|95.0|0.56|2.91|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.91|0.56|
71083888|NCT03311841|141673478|OTHER||Geometric least squares mean ratio|2.65|||||TWO_SIDED|95.0|1.21|5.81|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||5.81|1.21|
71122114|NCT03654885|141750247|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.3|STANDARD_ERROR_OF_MEAN|0.14||0.026|TWO_SIDED|95.0|0.04|0.59||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 6||0.59|0.04|0.026
71122115|NCT03654885|141750247|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.4|STANDARD_ERROR_OF_MEAN|0.14||0.01|TWO_SIDED|95.0|0.09|0.64||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 9||0.64|0.09|0.010
71122116|NCT03654885|141750247|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.3|STANDARD_ERROR_OF_MEAN|0.14||0.052|TWO_SIDED|95.0|0.0|0.54||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 12||0.54|0.00|0.052
71122117|NCT03654885|141750248|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|2.77|STANDARD_ERROR_OF_MEAN|1.229||0.024|TWO_SIDED|95.0|0.358|5.183||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables was used for analysis.|Mixed Model for Repeated Measures|||||5.183|0.358|0.024
71122118|NCT03654885|141750249|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.14||0.052|TWO_SIDED|95.0|0.0|0.54||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables was used for analysis.|Mixed Model for Repeated Measures|||||0.54|0.00|0.052
71122119|NCT03654885|141750250|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|1.79|STANDARD_ERROR_OF_MEAN|2.214||0.421|TWO_SIDED|95.0|-2.579|6.151||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables was used for analysis.|Mixed model repeated measures|||||6.151|-2.579|0.421
71083889|NCT03311841|141673478|OTHER||Geometric least squares mean ratio|1.49|||||TWO_SIDED|95.0|0.7|3.18|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||3.18|0.70|
71083890|NCT03311841|141673478|OTHER||Geometric least squares mean ratio|0.95|||||TWO_SIDED|95.0|0.43|2.08|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.08|0.43|
70856177|NCT01527357|141199152|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||< 0.0001
70856178|NCT01527357|141199153|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||< 0.0001
70856179|NCT01527357|141199154|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||< 0.0001
70856180|NCT01527357|141199155|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||< 0.0001
70856181|NCT02446171|141199160|SUPERIORITY_OR_OTHER||Ratio#|98.89|||||TWO_SIDED|90.0|92.4|105.84|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||105.84|92.40|
70856182|NCT02446171|141199160|SUPERIORITY_OR_OTHER||Ratio#|100.04|||||TWO_SIDED|90.0|93.17|107.43|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||107.43|93.17|
70856183|NCT02446171|141199160|SUPERIORITY_OR_OTHER||Ratio#|94.37|||||TWO_SIDED|90.0|88.7|100.4|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||100.40|88.70|
70856184|NCT02446171|141199161|SUPERIORITY_OR_OTHER||Ratio#|98.79|||||TWO_SIDED|90.0|92.24|105.8|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||105.80|92.24|
70856185|NCT02446171|141199161|SUPERIORITY_OR_OTHER||Ratio#|100.44|||||TWO_SIDED|90.0|93.65|107.72|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||107.72|93.65|
71122120|NCT03654885|141750251|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.25||0.18|TWO_SIDED|95.0|-0.16|0.84||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables was used for analysis.|Mixed Model for Repeated Measures|||||0.84|-0.16|0.180
71122121|NCT03654885|141750252|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-15.7||||0.064|TWO_SIDED|95.0|-33.0|2.3|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤18 mmHg||2.3|-33.0|0.064
71122122|NCT03654885|141750252|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-15.3||||0.078|TWO_SIDED|95.0|-32.7|2.5|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤17 mmHg||2.5|-32.7|0.078
71122123|NCT03654885|141750252|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-17.4||||0.051|TWO_SIDED|95.0|-34.7|0.4|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤16 mmHg||0.4|-34.7|0.051
71122124|NCT03654885|141750252|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-16.9||||0.064|TWO_SIDED|95.0|-34.1|1.0|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤15 mmHg||1.0|-34.1|0.064
71122125|NCT03654885|141750252|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-13.1||||0.2|TWO_SIDED|95.0|-30.5|4.8|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤14 mm Hg||4.8|-30.5|0.200
71122126|NCT03654885|141750252|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-20.0||||0.042|TWO_SIDED|95.0|-37.1|-2.0|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤13 mm Hg||-2.0|-37.1|0.042
71122127|NCT03654885|141750252|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-12.7||||0.18|TWO_SIDED|95.0|-30.1|5.2|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤12 mm Hg||5.2|-30.1|0.180
71122128|NCT03654885|141750253|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-3.6||||0.712|TWO_SIDED|95.0|-21.3|14.2|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥25% IOP Reduction||14.2|-21.3|0.712
71122129|NCT03654885|141750253|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-12.9||||0.201|TWO_SIDED|95.0|-30.3|5.0|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥30% IOP Reduction||5.0|-30.3|0.201
71122130|NCT03654885|141750253|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-20.3||||0.03|TWO_SIDED|95.0|-37.3|-2.3|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥35% IOP Reduction||-2.3|-37.3|0.030
71122131|NCT03654885|141750253|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-18.8||||0.043|TWO_SIDED|95.0|-36.0|-0.8|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥40% IOP Reduction||-0.8|-36.0|0.043
71122132|NCT03654885|141750253|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-17.9||||0.048|TWO_SIDED|95.0|-35.1|0.0|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥45% IOP Reduction||0.0|-35.1|0.048
71122133|NCT03654885|141750253|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-21.1||||0.015|TWO_SIDED|95.0|-38.1|-3.2|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥50% IOP Reduction||-3.2|-38.1|0.015
71122134|NCT03654885|141750254|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-11.7||||0.252|TWO_SIDED|95.0|-29.0|6.3|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤18 mm Hg||6.3|-29.0|0.252
71122135|NCT03654885|141750254|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-11.5||||0.258|TWO_SIDED|95.0|-28.9|6.5|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤17 mmHg||6.5|-28.9|0.258
70944508|NCT04159805|141389043|SUPERIORITY||Difference in LS Mean|-29.08|||=|0.077|TWO_SIDED|95.0|-61.36|3.21||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 5||3.21|-61.36|=0.077
71122136|NCT03654885|141750254|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-13.6||||0.139|TWO_SIDED|95.0|-30.9|4.4|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤16 mm Hg||4.4|-30.9|0.139
71122137|NCT03654885|141750254|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-14.7||||0.136|TWO_SIDED|95.0|-32.0|3.3|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤15 mm Hg||3.3|-32.0|0.136
71122138|NCT03654885|141750254|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.%.|Percentage Difference|-10.8||||0.274|TWO_SIDED|95.0|-28.2|7.1|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤14 mm Hg||7.1|-28.2|0.274
71122139|NCT03654885|141750254|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-17.7||||0.065|TWO_SIDED|95.0|-35.0|0.3|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤13 mm Hg||0.3|-35.0|0.065
71122140|NCT03654885|141750254|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-12.7||||0.18|TWO_SIDED|95.0|-30.1|5.2|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤12 mmHg||5.2|-30.1|0.180
71122141|NCT03654885|141750257|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|1.8||||1|TWO_SIDED|95.0|-41.6|44.1|||Fisher Exact|||||44.1|-41.6|1.000
71122142|NCT03654885|141750258|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-32.1||||0.215|TWO_SIDED|95.0|-66.8|10.0|||Fisher Exact|||||10.0|-66.8|0.215
71122143|NCT03654885|141750260|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-14.9||||0.144|TWO_SIDED|95.0|-32.2|3.1|||Fisher Exact|||||3.1|-32.2|0.144
71122144|NCT03654885|141750261|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-10.6||||0.254|TWO_SIDED|95.0|-28.0|7.3|||Fisher Exact|||||7.3|-28.0|0.254
71122145|NCT03654885|141750262|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-7.4||||0.563|TWO_SIDED|95.0|-28.6|14.2|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤18 mm Hg||14.2|-28.6|0.563
71122146|NCT03654885|141750262|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-12.5||||0.188|TWO_SIDED|95.0|-33.5|9.1|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤17 mm Hg||9.1|-33.5|0.188
71122147|NCT03654885|141750262|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-15.9||||0.118|TWO_SIDED|95.0|-36.7|5.6|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤16 mmHg||5.6|-36.7|0.118
71122148|NCT03654885|141750262|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-19.5||||0.085|TWO_SIDED|95.0|-40.2|2.1|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤15 mm Hg||2.1|-40.2|0.085
71122149|NCT03654885|141750262|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-21.3||||0.059|TWO_SIDED|95.0|-42.0|0.4|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤14 mm Hg||0.4|-42.0|0.059
71122150|NCT03654885|141750262|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-23.5||||0.045|TWO_SIDED|95.0|-43.9|-1.4|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤13 mm Hg||-1.4|-43.9|0.045
71122151|NCT03654885|141750262|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-20.8||||0.076|TWO_SIDED|95.0|-41.3|1.1|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤12 mm Hg||1.1|-41.3|0.076
71122152|NCT03654885|141750263|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-9.6||||0.464|TWO_SIDED|95.0|-31.0|12.1|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥ 25% IOP Reduction||12.1|-31.0|0.464
71122153|NCT03654885|141750263|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-19.8||||0.069|TWO_SIDED|95.0|-40.6|2.1|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥30% IOP Reduction||2.1|-40.6|0.069
71122154|NCT03654885|141750263|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-26.6||||0.023|TWO_SIDED|95.0|-46.9|-4.7|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥35% IOP Reduction||-4.7|-46.9|0.023
71122155|NCT03654885|141750263|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-23.7||||0.046|TWO_SIDED|95.0|-43.9|-1.6|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥40% IOP Reduction||-1.6|-43.9|0.046
71083891|NCT03311841|141673479|OTHER||Geometric least squares mean ratio|0.97|||||TWO_SIDED|95.0|0.63|1.48|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.48|0.63|
71083892|NCT03311841|141673479|OTHER||Geometric least squares mean ratio|1.06|||||TWO_SIDED|95.0|0.69|1.62|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.62|0.69|
71083893|NCT03311841|141673479|OTHER||Geometric least squares mean ratio|0.94|||||TWO_SIDED|95.0|0.62|1.41|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.41|0.62|
70856186|NCT02446171|141199161|SUPERIORITY_OR_OTHER||Ratio#|94.83|||||TWO_SIDED|90.0|89.2|100.82|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||100.82|89.20|
70856187|NCT02446171|141199162|SUPERIORITY_OR_OTHER||Ratio#|97.05|||||TWO_SIDED|90.0|88.09|106.92|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||106.92|88.09|
70856188|NCT02446171|141199162|SUPERIORITY_OR_OTHER||Ratio#|100.56|||||TWO_SIDED|90.0|91.8|110.16|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||110.16|91.80|
70856189|NCT02446171|141199162|SUPERIORITY_OR_OTHER||Ratio#|102.5|||||TWO_SIDED|90.0|93.13|111.82|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||111.82|93.13|
70856190|NCT04531462|141199177|SUPERIORITY|Null hypothesis: Mean change from baseline in HbA1c after 52 weeks of treatment with empagliflozin 10 mg = mean change from baseline in HbA1c after 52 weeks of treatment with placebo.|Mean Difference (Net)|-0.57|||<|0.0001|TWO_SIDED|95.0|-0.78|-0.36||Threshold level for statistical significance: α = 0.05 .|Mixed Model Repeated Measures (MMRM)||Empagliflozin 10 mg- Placebo|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) which included fixed classification effects for treatment, gender, baseline renal function, visit and visit-by-treatment interaction, and a linear covariate for baseline HbA1c and age. An unstructured covariance structure was used to model the within patient errors. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom.||-0.36|-0.78|<0.0001
70856191|NCT04531462|141199178|OTHER||Mean Difference (Net)|-0.61||||0.231|TWO_SIDED|95.0|-1.61|0.39|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline muscle mass, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||0.39|-1.61|0.2310
70856192|NCT04531462|141199179|OTHER||Mean Difference (Net)|-1.84|||<|0.0001|TWO_SIDED|95.0|-2.65|-1.04|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline body fat measurement, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||-1.04|-2.65|<0.0001
70856193|NCT04531462|141199180|OTHER||Mean Difference (Net)|-0.53||||0.1632|TWO_SIDED|95.0|-1.28|0.22|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline lean body mass, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||0.22|-1.28|0.1632
70856194|NCT04531462|141199181|OTHER||Mean Difference (Net)|-0.63||||0.0384|TWO_SIDED|95.0|-1.23|-0.03|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline total body water, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||-0.03|-1.23|0.0384
70856195|NCT04531462|141199182|OTHER||Mean Difference (Net)|-0.03||||0.1975|TWO_SIDED|95.0|-0.07|0.01|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline bone mineral content, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||0.01|-0.07|0.1975
70856196|NCT04531462|141199183|OTHER||Mean Difference (Net)|-0.081||||0.3725|TWO_SIDED|95.0|-0.259|0.098|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) which included baseline skeletal muscle index, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||0.098|-0.259|0.3725
70944509|NCT04159805|141389043|SUPERIORITY||Difference in LS Mean|-15.72|||=|0.33|TWO_SIDED|95.0|-47.45|16.0||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 5||16.00|-47.45|=0.330
71083894|NCT03311841|141673479|OTHER||Geometric least squares mean ratio|0.55|||||TWO_SIDED|95.0|0.36|0.83|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||0.83|0.36|
71083895|NCT03311841|141673479|OTHER||Geometric least squares mean ratio|0.84|||||TWO_SIDED|95.0|0.44|1.61|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||1.61|0.44|
71083896|NCT03311841|141673479|OTHER||Geometric least squares mean ratio|1.71|||||TWO_SIDED|95.0|0.89|3.27|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||3.27|0.89|
71083897|NCT03311841|141673479|OTHER||Geometric least squares mean ratio|1.75|||||TWO_SIDED|95.0|0.93|3.27|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||3.27|0.93|
71083898|NCT03311841|141673479|OTHER||Geometric least squares mean ratio|0.72|||||TWO_SIDED|95.0|0.38|1.38|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||1.38|0.38|
71083899|NCT03311841|141673479|OTHER||Geometric least squares mean ratio|1.49|||||TWO_SIDED|95.0|0.92|2.4|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.40|0.92|
71083900|NCT03311841|141673479|OTHER||Geometric least squares mean ratio|1.84|||||TWO_SIDED|95.0|1.14|2.98|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.98|1.14|
70944510|NCT04159805|141389043|SUPERIORITY||Difference in LS Mean|-14.14|||=|0.4|TWO_SIDED|95.0|-47.19|18.91||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||18.91|-47.19|=0.400
70944511|NCT04159805|141389043|SUPERIORITY||Difference in LS Mean|0.0|||=|1|TWO_SIDED|95.0|-32.18|32.19||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||32.19|-32.18|=1.000
70944512|NCT04159805|141389043|SUPERIORITY||Difference in LS Mean|-26.47|||=|0.117|TWO_SIDED|95.0|-59.64|6.69||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 7||6.69|-59.64|=0.117
71083901|NCT03311841|141673479|OTHER||Geometric least squares mean ratio|1.33|||||TWO_SIDED|95.0|0.84|2.11|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.11|0.84|
71083902|NCT03311841|141673479|OTHER||Geometric least squares mean ratio|1.47|||||TWO_SIDED|95.0|0.91|2.38|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.38|0.91|
71122156|NCT03654885|141750263|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-27.6||||0.014|TWO_SIDED|95.0|-47.6|-5.9|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥45% IOP Reduction||-5.9|-47.6|0.014
71122157|NCT03654885|141750263|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-30.9||||0.006|TWO_SIDED|95.0|-50.8|-9.5|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥50% IOP Reduction||-9.5|-50.8|0.006
71122158|NCT03654885|141750270|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.35||0.004|TWO_SIDED|95.0|0.33|1.72|||Mixed Model for Repeated Measures|MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses: Day 1||1.72|0.33|0.004
71122159|NCT03654885|141750270|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.36||0.001|TWO_SIDED|95.0|0.47|1.88||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Week 1||1.88|0.47|0.001
71122160|NCT03654885|141750270|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.36||0.162|TWO_SIDED|95.0|-0.2|1.2||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Week 2||1.20|-0.20|0.162
71122161|NCT03654885|141750270|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.36||0.185|TWO_SIDED|95.0|-0.23|1.19||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 1||1.19|-0.23|0.185
71122162|NCT03654885|141750270|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.36||0.846|TWO_SIDED|95.0|-0.64|0.79||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 3||0.79|-0.64|0.846
71122163|NCT03654885|141750270|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.36||0.965|TWO_SIDED|95.0|-0.73|0.7||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 6||0.70|-0.73|0.965
71122164|NCT03654885|141750270|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.37||0.096|TWO_SIDED|95.0|-0.11|1.33||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 9||1.33|-0.11|0.096
71122165|NCT03654885|141750270|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.37||0.063|TWO_SIDED|95.0|-0.04|1.43||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 12||1.43|-0.04|0.063
71083903|NCT03311841|141673479|OTHER||Geometric least squares mean ratio|1.19|||||TWO_SIDED|95.0|0.81|1.75|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.75|0.81|
70856197|NCT04531462|141199184|OTHER||Mean Difference (Net)|-0.3||||0.4208|TWO_SIDED|95.0|-1.1|0.5|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline grip strength, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||0.5|-1.1|0.4208
70856198|NCT04531462|141199185|OTHER||Mean Difference (Net)|0.0||||0.9267|TWO_SIDED|95.0|-1.0|0.9|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline 5-time chair stand test, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||0.9|-1.0|0.9267
70856199|NCT04175509|141199188|SUPERIORITY|||||||0.378|||||||t-test, 2 sided|||||||.378
70856200|NCT04175509|141199189|SUPERIORITY|||||||0.753|||||||t-test, 2 sided|||||||.753
70856201|NCT04175509|141199190|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.30
70856202|NCT04175509|141199191|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||||||0.43
71083904|NCT03311841|141673479|OTHER||Geometric least squares mean ratio|1.2|||||TWO_SIDED|95.0|0.82|1.76|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.76|0.82|
71083905|NCT03311841|141673479|OTHER||Geometric least squares mean ratio|1.08|||||TWO_SIDED|95.0|0.75|1.57|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.57|0.75|
70856203|NCT04175509|141199192|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||||||0.61
70856204|NCT04175509|141199193|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||||||0.77
70856205|NCT04175509|141199194|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||||||0.48
70856206|NCT04175509|141199195|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||||||0.78
70856207|NCT02564432|141199237|EQUIVALENCE|This is not a randomized clinical trial but is an observational study, each patient's thigh skin site served as the control.|Base mean abundance|0.03|||<|0.05|TWO_SIDED|||||The reported p-value was calculated.|Unweighted UniFrac (qualitative)|Both weighted and unweighted UniFrac were calculated; weighted UniFrac is calculated to be p = 0.398 while unweighted UniFrac was P\<0.03|Differential abundance of Staphylococcus aureus in the stoma calculated by Log2 fold change (y-axis) versus base mean abundance (x-axis)|Sample similarity was calculated using the statistical comparisons of community composition.||||<0.05
70856208|NCT02564432|141199237|OTHER|"In this study, dissimilarities between the stomal and healthy thigh skins were tested.~Observational study. Used only for visualizing trends in the data."|PERMANOVA|0.001|||<|0.005|TWO_SIDED|||||Each stomal community type was distinguished by both its diversity and taxonomic composition|Bray-Curtis dissimilarities|Nonmetric multidimensional scaling (NMDS) of Bray-Curtis dissimilarities|||Loess Regression was used to visualize temporal trends in the Shannnon Diversity and relative abundance of microbes (Staphylococcus, Streptococcus, Corynebacterium, and obligate anaerobes).|||<0.005
70856209|NCT00730028|141199239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.7688|TWO_SIDED|95.0|-7.6|5.1||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Primary null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess at the Test of Cure (TOC) visit.||5.1|-7.6|0.7688
70856210|NCT00730028|141199239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||1|TWO_SIDED|95.0|-5.4|5.1||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.||5.1|-5.4|1.0000
70856211|NCT00730028|141199239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4|||<|0.0001|TWO_SIDED|95.0|-19.2|-5.6||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.||-5.6|-19.2|<0.0001
70856212|NCT00730028|141199239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.2||||0.0002|TWO_SIDED|95.0|-19.1|-5.4||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.||-5.4|-19.1|0.0002
70856213|NCT00730028|141199242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.52|TWO_SIDED|95.0|-10.2|4.9||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Primary null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess at the Test of Cure (TOC) visit.||4.9|-10.2|0.5200
70944513|NCT04159805|141389043|SUPERIORITY||Difference in LS Mean|-12.75|||=|0.436|TWO_SIDED|95.0|-44.94|19.44||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 7||19.44|-44.94|=0.436
70944514|NCT04159805|141389043|SUPERIORITY|From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|Difference in LS Mean|-47.91|||=|0.005|TWO_SIDED|95.0|-81.54|-14.29||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||-14.29|-81.54|=0.005
70944515|NCT04159805|141389043|SUPERIORITY||Difference in LS Mean|-20.48|||=|0.215|TWO_SIDED|95.0|-52.92|11.95||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||11.95|-52.92|=0.215
70944516|NCT04159805|141389043|SUPERIORITY||Difference in LS Mean|-3.97|||=|0.815|TWO_SIDED|95.0|-37.34|29.4||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||29.40|-37.34|=0.815
70944517|NCT04159805|141389043|SUPERIORITY||Difference in LS Mean|-4.31|||=|0.794|TWO_SIDED|95.0|-36.84|28.22||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||28.22|-36.84|=0.794
70944518|NCT04159805|141389043|SUPERIORITY||Difference in LS Mean|-36.78|||=|0.033|TWO_SIDED|95.0|-70.48|-3.08||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||-3.08|-70.48|=0.033
70944519|NCT04159805|141389043|SUPERIORITY||Difference in LS Mean|-10.79|||=|0.513|TWO_SIDED|95.0|-43.26|21.67||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Week 12||21.67|-43.26|=0.513
70944520|NCT04159805|141389043|SUPERIORITY||Difference in LS Mean|-56.21|||=|0.002|TWO_SIDED|95.0|-91.69|-20.73||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Week 14||-20.73|-91.69|=0.002
70944521|NCT04159805|141389043|SUPERIORITY||Difference in LS Mean|-36.94|||=|0.036|TWO_SIDED|95.0|-71.39|-2.48||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Week 14||-2.48|-71.39|=0.036
70944522|NCT04159805|141389043|SUPERIORITY||Difference in LS Mean|-62.98|||=|0.001|TWO_SIDED|95.0|-100.64|-25.31||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Week 16||-25.31|-100.64|=0.001
70944523|NCT04159805|141389043|SUPERIORITY||Difference in LS Mean|-28.81|||=|0.13|TWO_SIDED|95.0|-66.12|8.51||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Week 16||8.51|-66.12|=0.130
71083906|NCT03311841|141673479|OTHER||Geometric least squares mean ratio|0.89|||||TWO_SIDED|95.0|0.61|1.31|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.31|0.61|
70944524|NCT04167085|141389048|SUPERIORITY|||||||0.16||||||Threshold p\<0.0167 - Because 3 primary outcomes were prespecified, the familywise error rate was adjusted for 3 endpoints: 0.05/3|Wilcoxon (Mann-Whitney)|||||||0.16
70944525|NCT04167085|141389049|SUPERIORITY|||||||0.05||||||Threshold p\<0.0167 - Because 3 primary outcomes were prespecified, the familywise error rate was adjusted for 3 endpoints: 0.05/3|Wilcoxon (Mann-Whitney)|||||||0.05
70944526|NCT04167085|141389050|SUPERIORITY|||||||0.19||||||Threshold p\<0.0167 - Because 3 primary outcomes were prespecified, the familywise error rate was adjusted for 3 endpoints: 0.05/3|Wilcoxon (Mann-Whitney)|||||||0.19
70944527|NCT04167085|141389051|SUPERIORITY|||||||0.24||||||Threshold p=0.05|Wilcoxon (Mann-Whitney)|||SF-12 Physical||||0.24
70944528|NCT04167085|141389051|SUPERIORITY|||||||0.35||||||Threshold p=0.05|Wilcoxon (Mann-Whitney)|||SF-12 Mental||||0.35
70944529|NCT04167085|141389052|SUPERIORITY|||||||0.5||||||Threshold p=0.05|Wilcoxon (Mann-Whitney)|||||||0.50
70944530|NCT04167085|141389053|SUPERIORITY|||||||0.3||||||Threshold p=0.05|Wilcoxon (Mann-Whitney)|||||||0.30
71083907|NCT03311841|141673479|OTHER||Geometric least squares mean ratio|1.48|||||TWO_SIDED|95.0|0.58|3.75|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||3.75|0.58|
71083908|NCT03311841|141673479|OTHER||Geometric least squares mean ratio|2.54|||||TWO_SIDED|95.0|1.11|5.85|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||5.85|1.11|
71083909|NCT03311841|141673479|OTHER||Geometric least squares mean ratio|2.16|||||TWO_SIDED|95.0|0.97|4.81|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||4.81|0.97|
71083910|NCT03311841|141673479|OTHER||Geometric least squares mean ratio|2.94|||||TWO_SIDED|95.0|1.28|6.77|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||6.77|1.28|
71083911|NCT03311841|141673479|OTHER||Geometric least squares mean ratio|1.11|||||TWO_SIDED|95.0|0.59|2.07|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.07|0.59|
71083912|NCT03311841|141673479|OTHER||Geometric least squares mean ratio|1.24|||||TWO_SIDED|95.0|0.71|2.17|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.17|0.71|
71083913|NCT03311841|141673479|OTHER||Geometric least squares mean ratio|0.94|||||TWO_SIDED|95.0|0.55|1.62|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||1.62|0.55|
71083914|NCT03311841|141673479|OTHER||Geometric least squares mean ratio|1.12|||||TWO_SIDED|95.0|0.64|1.96|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||1.96|0.64|
71083915|NCT03311841|141673479|OTHER||Geometric least squares mean ratio|1.1|||||TWO_SIDED|95.0|0.46|2.64|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.64|0.46|
71122166|NCT03654885|141750271|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.027||0.048|TWO_SIDED|95.0|-0.105|0.0|||Mixed Model for Repeated Measures|||Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen in LogMAR Scale: Month 1||0.000|-0.105|0.048
71122167|NCT03654885|141750271|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.027||0.742|TWO_SIDED|95.0|-0.062|0.045|||Mixed Model for Repeated Measures|||Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen in LogMAR Scale: Month 3||0.045|-0.062|0.742
71122168|NCT03654885|141750271|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.027||0.925|TWO_SIDED|95.0|-0.056|0.051|||Mixed Model for Repeated Measures|||Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen in LogMAR Scale: Month 6||0.051|-0.056|0.925
71122169|NCT03654885|141750271|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.028||0.021|TWO_SIDED|95.0|-0.118|-0.01|||Mixed Model for Repeated Measures|||Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen in LogMAR Scale: Month 12||-0.010|-0.118|0.021
71122170|NCT03654885|141750274|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.562|STANDARD_ERROR_OF_MEAN|0.3231||0.087|TWO_SIDED|95.0|-1.2082|0.0851|||Mixed Model for Repeated Measures|||Mean Change from Baseline in Surgically Induced Astigmatism - Topography at Selected Sites at Week 1||0.0851|-1.2082|0.087
71122171|NCT03654885|141750274|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.138|STANDARD_ERROR_OF_MEAN|0.3355||0.682|TWO_SIDED|95.0|-0.809|0.5324|||Mixed Model for Repeated Measures|||Mean Change from Baseline in Surgically Induced Astigmatism - Topography at Selected Sites at Month 1||0.5324|-0.8090|0.682
71122172|NCT03654885|141750274|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.452|STANDARD_ERROR_OF_MEAN|0.3484||0.199|TWO_SIDED|95.0|-1.1483|0.2434|||Mixed Model for Repeated Measures|||Mean Change from Baseline in Surgically Induced Astigmatism - Topography at Selected Sites at Month 12||0.2434|-1.1483|0.199
71083916|NCT03311841|141673479|OTHER||Geometric least squares mean ratio|1.87|||||TWO_SIDED|95.0|0.81|4.32|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||4.32|0.81|
71122173|NCT03654885|141750275|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.001|STANDARD_ERROR_OF_MEAN|0.2026||0.997|TWO_SIDED|95.0|-0.4103|0.4086|||Mixed Model for Repeated Measures|||Mean Change in Optical Biometry - Anterior Chamber Depth at Day 1||0.4086|-0.4103|0.997
71122174|NCT03654885|141750275|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.222|STANDARD_ERROR_OF_MEAN|0.2124||0.302|TWO_SIDED|95.0|-0.2068|0.6506|||Mixed Model for Repeated Measures|||Mean Change in Optical Biometry - Anterior Chamber Depth at Week 2||0.6506|-0.2068|0.302
70856214|NCT00730028|141199242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.7324|TWO_SIDED|95.0|-8.4|5.7||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.||5.7|-8.4|0.7324
70856215|NCT00730028|141199242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.2||||0.0001|TWO_SIDED|95.0|-22.0|-6.4||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.||-6.4|-22.0|0.0001
70856216|NCT00730028|141199242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.9||||0.0008|TWO_SIDED|95.0|-20.8|-5.0||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.||-5.0|-20.8|0.0008
70856217|NCT00730028|141199243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.7707|TWO_SIDED|95.0|-7.1|5.3||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess.||5.3|-7.1|0.7707
70856218|NCT00730028|141199243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3||||0.2141|TWO_SIDED|95.0|-2.0|8.5||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||8.5|-2.0|0.2141
70856219|NCT00730028|141199243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0||||0.0593|TWO_SIDED|95.0|-12.4|0.5||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||0.5|-12.4|0.0593
70856220|NCT00730028|141199243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2||||0.0017|TWO_SIDED|95.0|-15.3|-3.1||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||-3.1|-15.3|0.0017
70856221|NCT00730028|141199244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.1381|TWO_SIDED|95.0|-13.1|1.8||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess.||1.8|-13.1|0.1381
70856222|NCT00730028|141199244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.8302|TWO_SIDED|95.0|-6.4|8.2||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||8.2|-6.4|0.8302
70856223|NCT00730028|141199244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6||||0.0838|TWO_SIDED|95.0|-14.3|1.1||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||1.1|-14.3|0.0838
70856224|NCT00730028|141199244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5||||0.0507|TWO_SIDED|95.0|-15.2|0.2||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||0.2|-15.2|0.0507
70856225|NCT00730028|141199245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.1505|TWO_SIDED|95.0|-13.3|1.9||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess.||1.9|-13.3|0.1505
70856226|NCT00730028|141199245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.1666|TWO_SIDED|95.0|-10.9|2.2||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||2.2|-10.9|0.1666
70856227|NCT00730028|141199245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.5|||<|0.0001|TWO_SIDED|95.0|-23.0|-8.0||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||-8.0|-23.0|<0.0001
70856228|NCT00730028|141199245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.1||||0.0046|TWO_SIDED|95.0|-19.0|-3.2||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||-3.2|-19.0|0.0046
70944531|NCT04167085|141389054|SUPERIORITY|||||||1||||||Threshold p=0.05|Wilcoxon (Mann-Whitney)|||||||1.00
70944532|NCT01171183|141389061|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.52|STANDARD_DEVIATION|37.64||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
70944533|NCT01171183|141389062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_DEVIATION|4.54||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
70944534|NCT00835510|141389063|SUPERIORITY_OR_OTHER|||||||0.0127||95.0|||||Fisher Exact|two-sided||||||0.0127
71083917|NCT03311841|141673479|OTHER||Geometric least squares mean ratio|1.13|||||TWO_SIDED|95.0|0.51|2.53|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.53|0.51|
71083918|NCT03311841|141673479|OTHER||Geometric least squares mean ratio|1.04|||||TWO_SIDED|95.0|0.45|2.41|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.41|0.45|
71083919|NCT03311841|141673480|OTHER||Geometric least squares mean ratio|1.68|||||TWO_SIDED|95.0|0.78|3.62|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||3.62|0.78|
71083920|NCT03311841|141673480|OTHER||Geometric least squares mean ratio|1.3|||||TWO_SIDED|95.0|0.75|2.23|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.23|0.75|
71122175|NCT03654885|141750276|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.343|STANDARD_ERROR_OF_MEAN|0.3336||0.309|TWO_SIDED|95.0|-0.3289|1.0154|||Mixed Model for Repeated Measures|||Mean Change in from Baseline Optical Biometry - K1 at Day 1||1.0154|-0.3289|0.309
71122176|NCT03654885|141750276|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.261|STANDARD_ERROR_OF_MEAN|0.3278||0.43|TWO_SIDED|95.0|-0.3993|0.922|||Mixed Model for Repeated Measures|||Mean Change in from Baseline Optical Biometry - K1 at Week 2||0.9220|-0.3993|0.430
71122177|NCT03654885|141750276|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.409|STANDARD_ERROR_OF_MEAN|0.4457||0.363|TWO_SIDED|95.0|-1.3071|0.4882|||Mixed Model for Repeated Measures|||Mean Change in from Baseline Optical Biometry - K2 at Day 1||0.4882|-1.3071|0.363
71122178|NCT03654885|141750276|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.488|STANDARD_ERROR_OF_MEAN|0.4383||0.272|TWO_SIDED|95.0|-1.3709|0.3954|||Mixed Model for Repeated Measures|||Mean Change in from Baseline Optical Biometry - K2 at Week 2||0.3954|-1.3709|0.272
71122179|NCT03654885|141750276|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.765|STANDARD_ERROR_OF_MEAN|0.4502||0.096|TWO_SIDED|95.0|-1.6722|0.142|||Mixed Model for Repeated Measures|||Mean Change in from Baseline Optical Biometry - Delta D at Day 1||0.1420|-1.6722|0.096
71122180|NCT03654885|141750276|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.576|STANDARD_ERROR_OF_MEAN|0.4411||0.198|TWO_SIDED|95.0|-1.4655|0.3129|||Mixed Model for Repeated Measures|||Mean Change in from Baseline Optical Biometry - Delta D at Week 2||0.3129|-1.4655|0.198
71122181|NCT03654885|141750287|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-3.031|STANDARD_ERROR_OF_MEAN|4.3331||0.485|TWO_SIDED|95.0|-11.5597|5.4973|||Mixed Model for Repeated Measures|||PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Local Eye Symptoms Score||5.4973|-11.5597|0.485
71122182|NCT03654885|141750287|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-10.507|STANDARD_ERROR_OF_MEAN|4.5666||0.022|TWO_SIDED|95.0|-19.5|-1.5144|||Mixed Model for Repeated Measures|||PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Vision Function Problem Score||-1.5144|-19.5000|0.022
70944535|NCT00835510|141389063|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|two-sided||||||<0.0001
70944536|NCT00835510|141389068|NON_INFERIORITY_OR_EQUIVALENCE|The criteria for equivalence is that the 90% confidence interval for the difference in cure rate had to be between -20% to +20%.|Cure rate difference|-19.78||||||90.0|-30.27|-9.29||||||||-9.29|-30.27|
71122183|NCT03654885|141750287|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-7.528|STANDARD_ERROR_OF_MEAN|4.0382||0.064|TWO_SIDED|95.0|-15.4841|0.4275|||Mixed Model for Repeated Measures|||PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Total Bothersome Score||0.4275|-15.4841|0.064
71083921|NCT03311841|141673480|OTHER||Geometric least squares mean ratio|1.98|||||TWO_SIDED|95.0|1.15|3.41|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||3.41|1.15|
71122184|NCT03654885|141750287|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.42||0.278|TWO_SIDED|95.0|-1.28|0.37|||Mixed Model for Repeated Measures|||PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Local Eye Symptoms Frequency Score||0.37|-1.28|0.278
71083922|NCT03311841|141673480|OTHER||Geometric least squares mean ratio|0.98|||||TWO_SIDED|95.0|0.58|1.66|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||1.66|0.58|
71122185|NCT03654885|141750287|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.63||0.007|TWO_SIDED|95.0|-2.96|-0.47|||Mixed Model for Repeated Measures|||PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Vision Function Problem Frequency Score||-0.47|-2.96|0.007
71122186|NCT03654885|141750288|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.||||||0.534|||||||Fisher Exact|||PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Not at all||||0.534
71122187|NCT03654885|141750288|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.||||||0.263|||||||Fisher Exact|||PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Somewhat||||0.263
71083923|NCT03311841|141673480|OTHER||Geometric least squares mean ratio|1.03|||||TWO_SIDED|95.0|0.52|2.03|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||2.03|0.52|
71083924|NCT03311841|141673480|OTHER||Geometric least squares mean ratio|1.51|||||TWO_SIDED|95.0|0.77|2.97|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||2.97|0.77|
71083925|NCT03311841|141673480|OTHER||Geometric least squares mean ratio|1.07|||||TWO_SIDED|95.0|0.56|2.05|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||2.05|0.56|
71122188|NCT03654885|141750288|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.||||||1|||||||Fisher Exact|||PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Moderately so||||1.000
71122189|NCT03654885|141750288|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.||||||0.018|||||||Fisher Exact|||PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Mostly||||0.018
71122190|NCT03654885|141750288|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.||||||0.35|||||||Fisher Exact|||PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Completely||||0.350
71122191|NCT03654885|141750288|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.||||||0.264|||||||Fisher Exact|||PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Missing||||0.264
71122192|NCT03654885|141750289|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-8.303|STANDARD_ERROR_OF_MEAN|16.1445||0.61|TWO_SIDED|95.0|-40.8681|24.2624|||Mixed Model for Repeated Measures|||PRO: Percent Change From Baseline in Work Productivity and Activity Impairment- Percent Overall Work Impairment Due to Health||24.2624|-40.8681|0.610
71122193|NCT03654885|141750290|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-13.9|STANDARD_ERROR_OF_MEAN|8.33||0.097|TWO_SIDED|95.0|-30.32|2.52|||Mixed Model for Repeated Measures|||PRO: Percent Change From Baseline in Work Productivity and Activity Impairment-Percent Activity Impairment Due to Health||2.52|-30.32|0.097
71122194|NCT02209948|141750296|OTHER|Log Rank (Mantel-Cox)||||||0.943||||||Threshold P-value of 0.05|Log Rank|||||||0.943
70856229|NCT00730028|141199246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.4||||0.1815|TWO_SIDED|95.0|-13.6|2.8||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess.||2.8|-13.6|0.1815
71083926|NCT03311841|141673480|OTHER||Geometric least squares mean ratio|0.6|||||TWO_SIDED|95.0|0.3|1.17|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.17|0.30|
71083927|NCT03311841|141673480|OTHER||Geometric least squares mean ratio|1.57|||||TWO_SIDED|95.0|0.84|2.94|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atovastatin||2.94|0.84|
71083928|NCT03311841|141673480|OTHER||Geometric least squares mean ratio|1.49|||||TWO_SIDED|95.0|0.81|2.73|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atovastatin||2.73|0.81|
71122195|NCT02209948|141750297|OTHER||Hazard Ratio (HR)|1.3||||0.16|TWO_SIDED|95.0|0.9|1.88||Threshold of significance P-value 0.05|Regression, Cox|||||1.88|0.90|0.16
71122196|NCT02209948|141750298|OTHER||Hazard Ratio (HR)|1.0||||0.99|TWO_SIDED|95.0|0.65|1.5||Threshold for significance P-value 0.05|Regression, Cox|||||1.5|0.65|0.99
71122197|NCT02209948|141750299|OTHER||Hazard Ratio (HR)|1.45||||0.13|TWO_SIDED|95.0|0.89|2.33||threshold for significance 0.05|Regression, Cox|||||2.33|0.89|0.13
70856230|NCT00730028|141199246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6||||0.1552|TWO_SIDED|95.0|-13.2|2.1||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||2.1|-13.2|0.1552
70856231|NCT00730028|141199246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.9|||<|0.0001|TWO_SIDED|95.0|-24.0|-7.8||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||-7.8|-24.0|<0.0001
70856232|NCT00730028|141199246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4||||0.0145|TWO_SIDED|95.0|-18.7|-2.0||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||-2.0|-18.7|0.0145
70944537|NCT03713281|141389105|SUPERIORITY||Least-square mean|-0.131|STANDARD_ERROR_OF_MEAN|0.0278|||TWO_SIDED|95.0|-0.208|-0.054|||Linear Mixed Model|Kenward and Roger modethod for the demoninator degrees of freedom.||Statistically superiority will be concluded if the upper confidence limit will be less than 0.10 logMAR.||-0.054|-0.208|
71122198|NCT00289198|141750304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.256|||<|0.001|TWO_SIDED|95.0|-1.73|-0.78||Change from Baseline (Day 1) in reflective total nasal symptom scores for Placebo versus that for fluticasone furoate|ANCOVA|||||-0.78|-1.73|<0.001
71122199|NCT00289198|141750305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.459|||<|0.001|TWO_SIDED|95.0|-1.93|-0.99||Mean change from Baseline in AM pre-dose instantaneous TNSS over entire period for Placebo versus that for Fluticasone furoate|ANCOVA|||||-0.99|-1.93|<0.001
71122200|NCT00289198|141750306|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|Based on logistic regression adjusting for age, gender and country||||||<0.001
71122201|NCT00289198|141750307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.274|||<|0.001|TWO_SIDED|95.0|-1.74|-0.81|||ANCOVA|||||-0.81|-1.74|<0.001
71122202|NCT00289198|141750308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.291|||<|0.001|TWO_SIDED|95.0|-1.77|-0.81|||ANCOVA|||||-0.81|-1.77|<0.001
71122203|NCT00289198|141750309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.118|||<|0.001|TWO_SIDED|95.0|-20.03|-8.21|||ANCOVA|||||-8.21|-20.03|<0.001
71122204|NCT00289198|141750310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.033|||<|0.001|TWO_SIDED|95.0|-27.13|-12.94|||ANCOVA|||||-12.94|-27.13|<0.001
71122205|NCT00289198|141750311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.277|||<|0.001|TWO_SIDED|95.0|-0.41|-0.14|||ANCOVA|||Rhinorrhea score, Placebo vs Fluticasone furoate||-0.14|-0.41|<0.001
71122206|NCT00289198|141750311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.277|||<|0.001|TWO_SIDED|95.0|-0.42|-0.14|||ANCOVA|||Nasal Congestion, Placebo vs Fluticasone furoate||-0.14|-0.42|<0.001
71122207|NCT00289198|141750311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.331|||<|0.001|TWO_SIDED|95.0|-0.47|-0.2|||ANCOVA|||Nasal Itching, Placebo vs Fluticasone furoate||-0.20|-0.47|<0.001
71122208|NCT00289198|141750311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||<|0.001|TWO_SIDED|95.0|-0.52|-0.27|||ANCOVA|||Sneezing score, Placebo vs Fluticasone furoate||-0.27|-0.52|<0.001
71122209|NCT00289198|141750312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.357||||0.001|TWO_SIDED|95.0|-0.5|-0.22|||ANCOVA|||Rhinorrhea score, Placebo versus fluticasone furoate||-0.22|-0.50|0.001
71122210|NCT00289198|141750312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.001|TWO_SIDED|95.0|-0.51|-0.23|||ANCOVA|||Nasal Congestion score, Placebo versus fluticasone furoate||-0.23|-0.51|0.001
71122211|NCT00289198|141750312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.372||||0.001|TWO_SIDED|95.0|-0.5|-0.24|||ANCOVA|||Nasal itching score, Placebo versus fluticasone furoate||-0.24|-0.50|0.001
71122212|NCT00289198|141750312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.372||||0.001|TWO_SIDED|95.0|-0.5|-0.24|||ANCOVA|||Sneezing score, Placebo versus fluticasone furoate||-0.24|-0.50|0.001
71122213|NCT00289198|141750313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.281||||0.001|TWO_SIDED|95.0|-0.42|-0.14|||ANCOVA|||Rhinorrhea score,Placebo versus fluticasone furoate||-0.14|-0.42|0.001
71122214|NCT00289198|141750313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.314||||0.001|TWO_SIDED|95.0|-0.45|-0.17|||ANCOVA|||Nasal Congestion score, Placebo versus fluticasone furoate||-0.17|-0.45|0.001
71122215|NCT00289198|141750313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.324||||0.001|TWO_SIDED|95.0|-0.45|-0.19|||ANCOVA|||Nasal itching score, Placebo versus fluticasone furoate||-0.19|-0.45|0.001
71122216|NCT00289198|141750313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.374||||0.001|TWO_SIDED|95.0|-0.5|-0.25|||ANCOVA|||Sneezing score, Placebo versus fluticasone furoate||-0.25|-0.50|0.001
71122217|NCT00289198|141750314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.292|||<|0.001||95.0|-0.43|-0.15|||ANCOVA|||Rhinorrhea score, Placebo vs Fluticasone furoate||-0.15|-0.43|<0.001
71122218|NCT00289198|141750314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.264|||<|0.001|TWO_SIDED|95.0|-0.4|-0.12|||ANCOVA|||Nasal Congestion score, Placebo vs Fluticasone furoate||-0.12|-0.40|<0.001
71122219|NCT00289198|141750314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.336|||<|0.001|TWO_SIDED|95.0|-0.48|-0.2|||ANCOVA|||Nasal Itching score, Placebo vs Fluticasone furoate||-0.20|-0.48|<0.001
71122220|NCT00289198|141750314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.412|||<|0.001|TWO_SIDED|95.0|-0.54|-0.28|||ANCOVA|||Sneezing score, Placebo vs Fluticasone furoate||-0.28|-0.54|<0.001
71122221|NCT00289198|141750315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.506||||0.004|TWO_SIDED|95.0|-0.85|-0.16|||ANCOVA|||||-0.16|-0.85|0.004
71122222|NCT00289198|141750316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.491||||0.007||95.0|-0.85|-0.13|||ANCOVA|||||-0.13|-0.85|0.007
71122223|NCT00289198|141750317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.531||||0.003|TWO_SIDED|95.0|-0.88|-0.19|||ANCOVA|||||-0.19|-0.88|0.003
71122224|NCT00289198|141750318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.496||||0.005|TWO_SIDED|95.0|-0.84|-0.15|||ANCOVA|||||-0.15|-0.84|0.005
71083929|NCT03311841|141673480|OTHER||Geometric least squares mean ratio|1.44|||||TWO_SIDED|95.0|0.84|2.47|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.47|0.84|
71083930|NCT03311841|141673480|OTHER||Geometric least squares mean ratio|1.06|||||TWO_SIDED|95.0|0.63|1.78|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||1.78|0.63|
71083931|NCT03311841|141673480|OTHER||Geometric least squares mean ratio|1.85|||||TWO_SIDED|95.0|0.95|3.61|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||3.61|0.95|
71083932|NCT03311841|141673480|OTHER||Geometric least squares mean ratio|3.1|||||TWO_SIDED|95.0|1.64|5.86|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||5.86|1.64|
71083933|NCT03311841|141673480|OTHER||Geometric least squares mean ratio|1.75|||||TWO_SIDED|95.0|0.95|3.24|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||3.24|0.95|
71083934|NCT01462110|141673497|SUPERIORITY|The null hypothesis was the Week 4 mean is equal between the two cells. The alternative hypothesis was the Week 4 mean is not equal between the two cells.|Mean Difference (Net)|-0.234|STANDARD_ERROR_OF_MEAN|0.0211|<|0.001|TWO_SIDED|95.0|-0.276|-0.192|||ANCOVA|Terms for treatment as a factor \& baseline as a covariate.||||-0.192|-0.276|<0.001
71083935|NCT01462110|141673498|SUPERIORITY|The null hypothesis was the Week 4 mean is equal between the two cells. The alternative hypothesis was the Week 4 mean is not equal between the two cells.|Mean Difference (Net)|-1.232|STANDARD_ERROR_OF_MEAN|0.0806|<|0.001|TWO_SIDED|95.0|-1.392|-1.071|||ANCOVA|Terms for treatment as a factor \& baseline as a covariate.||||-1.071|-1.392|<0.001
71083936|NCT01462110|141673499|SUPERIORITY|The null hypothesis was the Week 2 mean is equal between the two cells. The alternative hypothesis was the Week 2 mean is not equal between the two cells.|Mean Difference (Net)|-0.106|STANDARD_ERROR_OF_MEAN|0.0173|<|0.001|TWO_SIDED|95.0|-0.14|-0.071|||ANCOVA|Terms for treatment as a factor \& baseline as a covariate.||||-0.071|-0.140|<0.001
71083937|NCT01462110|141673500|SUPERIORITY|The null hypothesis was the Week 2 mean is equal between the two cells. The alternative hypothesis was the Week 2 mean is not equal between the two cells.|Mean Difference (Net)|-0.83|STANDARD_ERROR_OF_MEAN|0.0957|<|0.001|TWO_SIDED|95.0|-1.02|-0.639|||ANCOVA|Terms for treatment as a factor \& baseline as a covariate.||||-0.639|-1.020|<0.001
71083938|NCT01462110|141673501|SUPERIORITY|The null hypothesis was the Week 2 mean is equal between the two cells. The alternative hypothesis was the Week 2 mean is not equal between the two cells.|Mean Difference (Net)|-0.044|STANDARD_ERROR_OF_MEAN|0.0076|<|0.001|TWO_SIDED|95.0|-0.059|-0.029|||ANCOVA|Terms for treatment as a factor \& baseline as a covariate.||||-0.029|-0.059|<0.001
71083939|NCT01462110|141673502|SUPERIORITY|The null hypothesis was the Week 4 mean is equal between the two cells. The alternative hypothesis was the Week 4 mean is not equal between the two cells.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.0087|<|0.001|TWO_SIDED|95.0|-0.078|-0.043|||ANCOVA|Terms for treatment as a factor \& baseline as a covariate.||||-0.043|-0.078|<0.001
71083940|NCT00534638|141673518|SUPERIORITY||Vaccine effectiveness percentage|49.6||||0.004|TWO_SIDED|95.0|20.1|68.2||An objective was reached if the 2-sided p-value associated to the objective was below 5%.|Cochran-Mantel-Haenszel|||Overall efectiveness against HPV-16/18 Cervarix/Engerix-B B Group vs Engerix-B Group: The analysis of the overall effectiveness of GSK's HPV-16/18 vaccine against HPV-16/18 genital infection in Cervarix/Engerix-B B Group versus Engerix-B Group was based on stratified Mantel-Haenszel adjusted for clustering.||68.2|20.1|0.004
71083941|NCT00534638|141673518|SUPERIORITY||Vaccine effectiveness percentage|23.8||||0.232|TWO_SIDED|95.0|-19.0|51.1||An objective was reached if the 2-sided p-value associated to the objective was below 5%.|Cochran-Mantel-Haenszel|||Overall efectiveness against HPV-16/18 Cervarix/Engerix-B A Group vs Engerix-B Group: The analysis of the overall effectiveness of GSK's HPV-16/18 vaccine against HPV-16/18 genital infection in Cervarix/Engerix-B A Group versus Engerix-B Group was based on stratified Mantel-Haenszel adjusted for clustering.||51.1|-19.0|0.232
71083942|NCT00534638|141673519|SUPERIORITY||Vaccine effectiveness percentage|-52.2||||0.069|TWO_SIDED|95.0|-139.4|3.3||An objective was reached if the 2-sided p-value associated to the objective was below 5%.|Cochran-Mantel-Haenszel|||Overall efectiveness against HPV-16/18 Cervarix/Engerix-B A Group vs Cervarix/Engerix-B B Group: The analysis of the overall effectiveness of GSK's HPV-16/18 vaccine against HPV-16/18 genital infection in Cervarix/Engerix-B A Group versus Cervarix/Engerix-B B was based on stratified Mantel-Haenszel adjusted for clustering.||3.3|-139.4|0.069
71083943|NCT04878055|141673581|SUPERIORITY||Odds Ratio (OR)|1.626||||0.216|TWO_SIDED|95.0|0.752|3.514|||Two-sided regression, Logistic|||Analysis is based on logistic regression model with Multiple Imputation under missing not at random using retrieve dropouts with proportion of patients alive and free of respiratory failure at Day 28 as dependent variable, treatment, age group, gender and presence of concomitant disease at baseline as qualitative independent variables. Site is considered as random effects that vary randomly among patients.||3.514|0.752|0.216
71083944|NCT04878055|141673582|SUPERIORITY|||||||0.377|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared test.||||||0.377
71083945|NCT04878055|141673583|SUPERIORITY|Analysis is based on logistic regression model with proportion of patients died up to Date 28 as dependent variable, treatment, age group, gender and presence of concomitant disease at baseline as qualitative independent variables. Site is considered as random effects that vary randomly among patients.|Odds Ratio (OR)|0.468||||0.17|TWO_SIDED|95.0|0.158|1.386|||Two-sided regression, Logistic|||||1.386|0.158|0.17
71083946|NCT04878055|141673584|SUPERIORITY||Odds Ratio (OR)|0.561||||0.168|TWO_SIDED|95.0|0.247|1.277|||Regression, Logistic|||||1.277|0.247|0.168
71083947|NCT04878055|141673585|SUPERIORITY|Estimates are calculated using a nonparametric method for cumulative incidence function with competing risks data. Estimates were calculated taking into account the following competing risks: Death, discontinuation for AEs and patient transferred to another institution.||||||0.167|||||||Gray's Test|||Until Day 28||||0.167
71083948|NCT04878055|141673586|SUPERIORITY|||||||0.55||||||Comparison between treatment arms is performed by means of a Fisher's Exact test.|Fisher Exact|||At Day 3 - please note that the number of subjects is 268 (180+88) and not 270.||||0.55
71083949|NCT04878055|141673586|SUPERIORITY|||||||0.128|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared mean.||At Day 7 - Please note that the total of subjects in this analysis is not 270 but 266 (n=179 in the Reparixin group and n=87 in the placebo group).||||0.128
71083950|NCT04878055|141673586|SUPERIORITY|||||||0.235|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared test.||At Day 14 - Please note that the total of subjects in this analysis is not 270 but 256 (n=173 in the Reparixin group and n=83 in the placebo group).||||0.235
70944538|NCT03713281|141389106|SUPERIORITY||Least-square means|0.06|STANDARD_ERROR_OF_MEAN|0.0278|||TWO_SIDED|95.0|-0.017|0.137|||Linear Mixed Model|Kenward and Roger method for the demoninator degrees of freedom.||Statistically superiority will be concluded if the upper confidence limit will be less than 0.17 logMAR for near distance logMAR visual acuity.||0.137|-0.017|
71122225|NCT00289198|141750319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.216||||0.001|TWO_SIDED|95.0|-0.34|-0.09|||ANCOVA|||Eye itching/burning score, Placebo vs fluticasone furoate||-0.09|-0.34|0.001
71122226|NCT00289198|141750319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.137||||0.028|TWO_SIDED|95.0|-0.26|-0.02|||ANCOVA|||Eye tearing/watering score, Placebo vs fluticasone furoate||-0.02|-0.26|0.028
71122227|NCT00289198|141750319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.156||||0.01|TWO_SIDED|95.0|-0.27|-0.04|||ANCOVA|||Eye redness, Placebo vs fluticasone furoate||-0.04|-0.27|0.010
71122228|NCT00289198|141750320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.215||||0.002|TWO_SIDED|95.0|-0.35|-0.08|||ANCOVA|||Eye itching/burning score, Placebo vs fluticasone furoate||-0.08|-0.35|0.002
71122229|NCT00289198|141750320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.161||||0.016||95.0|-0.29|-0.03|||ANCOVA|||Eye tearing or watering, Placebo vs fluticasone furoate||-0.03|-0.29|0.016
71122230|NCT00289198|141750320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.113||||0.076|TWO_SIDED|95.0|-0.24|-0.01|||ANCOVA|||Eye redness score, Placebo vs fluticasone furoate||-0.01|-0.24|0.076
71122231|NCT00289198|141750321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.211||||0.001|TWO_SIDED|95.0|-0.34|-0.08|||ANCOVA|||Eye itching/burning score, Placebo vs Fluticasone furoate||-0.08|-0.34|0.001
71122232|NCT00289198|141750321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.145||||0.023|TWO_SIDED|95.0|-0.27|-0.02|||ANCOVA|||Eye tearing/watering, Placebo vs Fluticasone furoate||-0.02|-0.27|0.023
71122233|NCT00289198|141750321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.176||||0.005|TWO_SIDED|95.0|-0.3|-0.05|||ANCOVA|||Eye Redness score, Placebo vs Fluticasone furoate||-0.05|-0.30|0.005
71122234|NCT00289198|141750322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.223||||0.001|TWO_SIDED|95.0|-0.35|-0.09|||ANCOVA|||Eye itching/burning, Placebo vs fluticasone furoate||-0.09|-0.35|0.001
71122235|NCT00289198|141750322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.04|TWO_SIDED|95.0|-0.25|-0.01|||ANCOVA|||Eye Tearing/Watering score, Placebo vs fluticasone furoate||-0.01|-0.25|0.040
71122236|NCT00289198|141750322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.142||||0.022|TWO_SIDED|95.0|-0.26|-0.02|||ANCOVA|||Eye Redness score, Placebo vs fluticasone furoate||-0.02|-0.26|0.022
71122237|NCT00289198|141750323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.376||||0.004|TWO_SIDED|95.0|2.71|14.04|||ANCOVA|||||14.04|2.71|0.004
71122238|NCT00289198|141750324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.28||||0.002|TWO_SIDED|95.0|3.52|15.04|||ANCOVA|||||15.04|3.52|0.002
71122239|NCT00289198|141750325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.638||||0.009|TWO_SIDED|95.0|1.89|13.39|||ANCOVA|||||13.39|1.89|0.009
71122240|NCT02406443|141750333|SUPERIORITY||Mean Difference (Final Values)|46.0|||=|0.012|TWO_SIDED||||||Regression, Linear|||||||=0.012
71122241|NCT02406443|141750334|SUPERIORITY||Median Difference (Final Values)|5.7||||0.4|TWO_SIDED||||||Regression, Linear|||||||0.40
71122242|NCT02406443|141750335|SUPERIORITY||Mean Difference (Final Values)|22.0||||0.15|TWO_SIDED||||||Regression, Linear|||||||0.15
70856233|NCT03811093|141199247|SUPERIORITY||Mean Difference (Net)|2.036|||<|0.01|TWO_SIDED|95.0|1.243|2.828||p-value is calculated using SPSS.|t-test, 2 sided|||The null hypothesis states that in the population from where the sample was obtained there was no difference between the intervention (invisa-RED Elite) and placebo groups in the mean change in the primary outcome variable, i.e. Change in Body Fat Percentage.||2.828|1.243|<0.01
70856234|NCT03811093|141199247|OTHER|||||||0.2||||||The significance value has been Lilliefors corrected and represents the lower bound of the true significance.|Kolmogorov-Smirnov Test|||"A single sample Kolmogorov-Smirnov normality test was used to examine if variables are normally distributed for the population from which the trial groups are drawn.~The null hypothesis is that the distribution of Percent of Body Fat Lost or Gained is normal with mean -.83 and standard deviation 1.50218."||||0.20
70856235|NCT03811093|141199247|OTHER|||||||0.075|||||||Levene's Test for Equality of Variance|||To test that the trial participant's population variances are equal (or exhibit homogeneity of variance), a Levene's Test for Equality of Variance was conducted. It tests the null hypothesis that the population variances are equal (called homogeneity of variance or homoscedasticity). For this test if the resulting p-value of Levene's test is less than .05, the obtained differences in sample variances are unlikely to have occurred based on random sampling from a population with equal variances.||||0.075
70856236|NCT03811093|141199248|SUPERIORITY||Mean Difference (Net)|7.063|||<|0.01|TWO_SIDED|95.0|3.829|10.296||p-value is calculated using SPSS.|t-test, 2 sided|||Designed as a superiority trial with the aim of establishing whether the intervention was superior or inferior to a placebo in effectiveness as a therapy for change over time in measured body circumference. The null hypothesis states that in the population from where the sample was obtained there was no difference between the intervention (invisa-RED Elite) and placebo groups in the mean change in the primary outcome variable, i.e. measured body circumference.||10.296|3.829|<0.01
70856237|NCT03811093|141199248|OTHER|||||||0.2||||||The significance value has been Lilliefors corrected and represents the lower bound of the true significance.|Kolmogorov-Smirnov Test|||"A Kolmogorov-Smirnov normality test was used to examine if variables are normally distributed for the population from which the trial groups are drawn.~The null hypothesis is that the distribution of Total Inches Lost or Gained is normal with mean -7.136 and standard deviation 5.796."||||0.20
70944539|NCT00225277|141389200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.886||||0.002||95.0|-1.448|-0.325|||ANCOVA||Mean Difference = Pioglitazone - Glimepiride|2 Way analysis of covariance (ANCOVA), treatment and center effects with baseline value as covariate. Least Squares (LS) mean change and LS mean of the treatment difference reported.||-0.3250|-1.4480|0.002
71122243|NCT02406443|141750336|SUPERIORITY||Mean Difference (Final Values)|0.5|||<|0.001|TWO_SIDED||||||Regression, Linear|||||||<0.001
71122244|NCT02406443|141750337|SUPERIORITY||Mean Difference (Final Values)|2.4|||<|0.001|TWO_SIDED||||||Regression, Linear|||||||<0.001
71122245|NCT02406443|141750338|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.42|TWO_SIDED||||||Regression, Linear|||||||0.42
71122246|NCT01062061|141750341|SUPERIORITY_OR_OTHER|||||||0.9733||95.0|||||Chi-squared|||||||0.9733
71122247|NCT01062061|141750342|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Chi-squared|||||||0.0001
71122248|NCT03180398|141750384|SUPERIORITY|It was hoped to compare radiomics features, using non-parametric tests, but this was not possible because of the small number of patients accrued.|||||||||||||||||Not enough patients were accrued for radiomics analysis. PI left institution and country. Analysis could not be completed.|||
71122249|NCT03180398|141750385|OTHER|Analysis could not be completed.|||||||||||||||||PI left institution and country. Analysis could not be completed.|||
71122250|NCT01605227|141750402|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9||||0.213|TWO_SIDED|95.0|0.76|1.06|||Log Rank|The Log-Rank test was stratified by prior cabazitaxel, baseline pain severity and baseline ECOG performance status.||||1.06|0.76|0.213
71122251|NCT01605227|141750403|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel (CMH) Test was stratified by prior cabazitaxel, baseline pain severity and baseline ECOG performance status.||||||<0.001
71122252|NCT01605227|141750404|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|95.0|0.4|0.57|||Log Rank|The Log-Rank Test was stratified by prior cabazitaxel, baseline pain severity, and baseline Eastern Cooperative Oncology Group Performance Status.||||0.57|0.40|<0.001
71122253|NCT03093974|141750407|SUPERIORITY|The number of NCFB pulmonary exacerbations was compared between treatment groups using a negative binomial model including treatment, pooled site (country) and baseline use of stable concomitant therapy with oral macrolides as fixed effects and log-time on treatment as an offset.|LS Mean rate ratio|0.612||||0.00101|TWO_SIDED|95.0|0.457|0.82|||two-sided Wald chi-square test|||||0.820|0.457|0.00101
71122254|NCT00700102|141750465|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.0062|TWO_SIDED|95.0|0.69|0.94|||Log Rank|||||0.94|0.69|0.0062
71122255|NCT00700102|141750466|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.1713|TWO_SIDED|95.0|0.77|1.05|||Log Rank|||Kaplan Meier Estimate||1.05|0.77|0.1713
71122256|NCT00700102|141750468|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|95.0|0.59|0.78|||Log Rank|||||0.78|0.59|<.0001
71122257|NCT00700102|141750469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.3113|TWO_SIDED|95.0|-1.5|4.5|||Chi-squared|||||4.5|-1.5|0.3113
71122258|NCT00700102|141750469|SUPERIORITY_OR_OTHER|||||||0.4315|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.4315
71122259|NCT01811303|141750471|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
71122260|NCT01811303|141750471|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.016||95.0|||||ANOVA|||||||<0.016
71122261|NCT02525939|141750473|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.12|TWO_SIDED|95.0|0.75|1.03||The estimated HR was presented with a 95% CI and a p-value. The primary analysis was conducted at the 0.05 significance level.|Stratified Cox proportional hazard model|||A stratified Cox proportional hazards model was used to analyze the primary endpoint. This model included treatment as a main effect, and region and acute coronary syndrome (ACS) index event type as stratification factors. The null and alternative hypotheses tested with the above Cox model were: H0: λ = 1 vs HA: λ ≠ 1, where λ is the, assumed constant, hazard ratio (HR) for the time to occurrence of the composite events of the primary endpoint for the dalcetrapib and placebo treated groups.||1.03|0.75|0.12
70856238|NCT03811093|141199248|OTHER|||||||0.44|||||||Levene's Test for Equality of Variance|||To test that the trial participant's population variances are equal (or exhibit homogeneity of variance), a Levene's Test for Equality of Variance was conducted. It tests the null hypothesis that the population variances are equal (called homogeneity of variance or homoscedasticity). For this test if the resulting p-value of Levene's test is less than .05, the obtained differences in sample variances are unlikely to have occurred based on random sampling from a population with equal variances.||||0.44
70944540|NCT00225277|141389201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.048||||0.064||95.0|-8.3336|0.2374|||ANCOVA||Mean Difference = Pioglitazone - Glimepiride|2 Way ANCOVA, treatment and center effects with baseline value as covariate. LS mean of the treatment difference reported.||0.2374|-8.3336|0.064
71122262|NCT02525939|141750474|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.95|TWO_SIDED|95.0|0.88|1.13|||Stratified Cox proportional hazard model|||Secondary endpoints were expressed as time to event and an analysis similar to that for the primary endpoint was conducted. In order to control the family-wise Type I error that results from the multiplicity of endpoints, the secondary endpoints were formally tested using the Hochberg's step-up procedure only if the primary analysis results in significant treatment effect at p\<0.05. Otherwise, statistical tests for the secondary endpoints were presented solely for illustrative purposes.||1.13|0.88|0.95
71122263|NCT02525939|141750475|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.27|TWO_SIDED|95.0|0.79|1.07|||Stratified Cox proportional hazard model|||Secondary endpoints were expressed as time to event and an analysis similar to that for the primary endpoint was conducted. In order to control the family-wise Type I error that results from the multiplicity of endpoints, the secondary endpoints were formally tested using the Hochberg's step-up procedure only if the primary analysis results in significant treatment effect at p\<0.05. Otherwise, statistical tests for the secondary endpoints were presented solely for illustrative purposes.||1.07|0.79|0.27
71122264|NCT00762996|141750496|NON_INFERIORITY_OR_EQUIVALENCE|"margin +/- 0.5 logMar lines~The range of non-inferiority for this value is 0.50 thus +/- 0.50 is considered non-inferior to the 0.0 mark.~logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal."|Mean Difference (Final Values)|0.005287|STANDARD_ERROR_OF_MEAN|0.00976||||95.0|-0.01389|0.2447|||Mixed Models Analysis||logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.|Null Hypothesis: etafilcon A is greater than or equal to omafilcon A.||0.2447|-0.01389|
71122265|NCT00762996|141750497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4757|STANDARD_ERROR_OF_MEAN|0.2505||||95.0|0.05563|0.4757|||Mixed Models Analysis||Mean difference is etafilcon A minus omafilcon A.|||0.4757|0.05563|
71122266|NCT02084238|141750514|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparing the data between baseline and week 10.||||<0.01
71122267|NCT00320372|141750519|SUPERIORITY_OR_OTHER||MMRM Least Squares Mean|38.1|||||TWO_SIDED|95.0|36.3|39.9|||||Mixed Model Repeated Measure analysis on MADRS responders (binary variable with 1=yes, 0=no) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|Null Hypothesis: Percentage of responders across groups is the same. Alternate Hypothesis: Percentage of responders across groups is different.||39.9|36.3|
71122268|NCT00320372|141750519|SUPERIORITY_OR_OTHER||MMRM Least Squares Mean|17.0|||||TWO_SIDED|95.0|15.2|19.0|||||Mixed Model Repeated Measure analysis on MADRS responders (binary variable with 1=yes, 0=no) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|Null Hypothesis: Percentage of responders across groups is the same. Alternate Hypothesis: Percentage of responders across groups is different.||19.0|15.2|
71122269|NCT00320372|141750519|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Null Hypothesis: Percentage of responders across groups is the same. Alternate Hypothesis: Percentage of responders across groups is different.||||<.0001
71122270|NCT00320372|141750520|SUPERIORITY_OR_OTHER|||||||0.1015|TWO_SIDED|||||Comparison for Kaplan Meier Median Time until recurrence|Log Rank|Null hypothesis: median TUR between 2 groups is not different. Alternate hypothesis: median TUR between 2 groups is different.||||||0.1015
71122271|NCT00320372|141750521|SUPERIORITY_OR_OTHER||MMRM Least Squares Mean|19.8|||||TWO_SIDED|95.0|18.4|21.3|||||Mixed Model Repeated Measure analysis on MADRS remitters (binary variable with 1=yes, 0=no) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|Null Hypothesis: Percentage of remitters across groups is the same. Alternate Hypothesis: Percentage of remitters across groups is different.||21.3|18.4|
71122272|NCT00320372|141750521|SUPERIORITY_OR_OTHER||MMRM Least Squares Mean|8.1|||||TWO_SIDED|95.0|6.9|9.5|||||Mixed Model Repeated Measure analysis on MADRS remitters (binary variable with 1=yes, 0=no) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|Null Hypothesis: Percentage of remitters across groups is the same. Alternate Hypothesis: Percentage of remitters across groups is different.||9.5|6.9|
71122273|NCT00320372|141750521|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Null Hypothesis: Percentage of responders across groups is the same. Alternate Hypothesis: Percentage of responders across groups is different.||||<.0001
71122274|NCT00320372|141750527|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficients|0.34997|||<|0.0001|TWO_SIDED|||||"Null hypothesis: There is a correlation between MADRS follow-up suicidal thoughts and baseline suicidal thoughts.~Alternate hypothesis: There is no correlation between MADRS follow-up suicidal thoughts and baseline suicidal thoughts."|Pearson Correlation Coefficients|||The statistical modeling of predictors of suicide attempts and suicidal ideations considered 15 variables, defined in the protocol a priori to determine which ones were predictive of suicide attempts and suicidal ideations. Four variables representing the baseline disease and patient factors were considered predictors of suicidality. This outcome measure presents the underlying data collected and the corresponding correlation coefficient for one of the 4 variables identified.||||<0.0001
71122275|NCT00320372|141750528|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||3 Month Time point||||<.0001
70944541|NCT00225277|141389202|SUPERIORITY_OR_OTHER|||||||0.744||||||Kaplan-Meier methodology was used to estimate the time to event for each composite endpoint. The p-value was based on a log-rank test.|Log Rank|||||||0.744
71122276|NCT00320372|141750528|SUPERIORITY_OR_OTHER|||||||0.0068|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||6 Month Time point||||.0068
71122277|NCT00320372|141750528|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||9 Month Time point||||.0008
71122278|NCT00320372|141750528|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||12 Month Time point||||.0003
71122279|NCT00320372|141750528|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||18 Month Time point||||<.0001
71122280|NCT00320372|141750528|SUPERIORITY_OR_OTHER|||||||0.0059|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||24 Month Time point||||.0059
71122281|NCT00320372|141750528|SUPERIORITY_OR_OTHER|||||||0.0028|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||30 Month Time point||||.0028
71122282|NCT00320372|141750528|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||36 Month Time point||||.0002
70856239|NCT03811093|141199249|SUPERIORITY||Mean Difference (Net)|4.4703|||<|0.01|TWO_SIDED|95.0|2.3372|6.6034||p-value is computed using SPSS.|t-test, 2 sided|||Designed as a superiority trial with the aim of establishing whether the intervention was superior or inferior to a placebo in effectiveness as a therapy for change in body fat, measured in pounds. The null hypothesis states that in the population from where the sample was obtained there was no difference between the intervention (invisa-RED Elite) and placebo groups in the mean change in the primary outcome variable, i.e. change in pounds of body fat.||6.6034|2.3372|<0.01
70856240|NCT03811093|141199249|OTHER|||||||0.2||||||The significance value has been Lilliefors corrected and represents the lower bound of the true significance.|Kolmogorov-Smirnov Test|||"A single sample Kolmogorov-Smirnov normality test was used to examine if variables are normally distributed for the population from which the trial groups are drawn.~The null hypothesis is that the distribution of the Weight of Body Fat Lost or Gained is normal with mean -2.49 and standard deviation 3.71209."||||.200
70856241|NCT03811093|141199249|OTHER|||||||0.438|||||||Levene's Test for Equality of Variance|||To test that the trial participant's population variances are equal (or exhibit homogeneity of variance), a Levene's Test for Equality of Variance was conducted. It tests the null hypothesis that the population variances are equal (called homogeneity of variance or homoscedasticity). For this test if the resulting p-value of Levene's test is less than .05, the obtained differences in sample variances are unlikely to have occurred based on random sampling from a population with equal variances.||||.438
70856242|NCT00464490|141199250|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||P-value \<0.05 was considered significant|t-test, 2 sided|||H(0): Ventilator time (DG) = Ventilator time (CG)||||0.02
70856243|NCT01227824|141199288|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority could be concluded if the lower bound of a two-sided 95% confidence interval for the difference (DTG - RAL) in percentages between the two treatment arms was \> -10%.|Difference in percentage|2.5|||||TWO_SIDED|95.0|-2.2|7.1|||||Analysis was based on Cochran-Mantel Haenszel stratified analysis adjusted for the following Baseline stratification factors: baseline HIV-1 RNA and background dual NRTI.|||7.1|-2.2|
70856244|NCT02589600|141199307|SUPERIORITY||Incident Rate Ratio|1.05||||0.7251|TWO_SIDED|95.0|0.9|1.22|||Negative binomial regression||Placebo group is the reference group||Negative binomial regression implemented in the SAS®️ GENMOD procedure with fracture outcome as the dependent variable; duration of follow-up as an offset to account for each participant's exposure; treatment arm as the main independent factor of interest.|1.22|.90|0.7251
70856245|NCT01816451|141199315|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||For pre-post training variables data were expressed as mean and standard deviation. Heart Rate and Blood Lactate, were by three-way ANOVA (Measure x Group x Time) with repeated measures for the factors Measure and Time. The variables absolute and relative VO2, tVO2, Body Fat, Body Mass, RPE, were made two-way ANOVAs (Group x Measure) with repeated measures on the factor Measure. Where the ANOVA was significant, the Tukey-Kramer as post-hoc was used.||||< 0.05
71122283|NCT00320372|141750528|SUPERIORITY_OR_OTHER|||||||0.0051|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||42 Month Time point||||.0051
71122284|NCT00320372|141750528|SUPERIORITY_OR_OTHER|||||||0.0363|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||48 Month Time point||||.0363
70856246|NCT01816451|141199315|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||For pre; during (retest I 0-6weeks; retest II 0-10 weeks) and post training data were expressed as mean and standard deviation. HR and \[La\], were by three-way ANOVA (Measure x Group x Time) with repeated measures for the factors Measure and Time. The variables RPE, Velocity were made two-way ANOVAs (Group x Measure) with repeated measures on the factor Measure. Where the ANOVA was significant, the Tukey-Kramer as post-hoc was used. Control didn't do submaximal test for training intensities.||||<0.05
70944542|NCT00225277|141389203|SUPERIORITY_OR_OTHER|||||||0.883||95.0||||Kaplan-Meier methodology was used to estimate the time to event for each composite endpoint. The p-value was based on a log-rank test.|Log Rank|||||||0.883
71122285|NCT00320372|141750528|SUPERIORITY_OR_OTHER|||||||0.0048|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||54 Month Time point||||.0048
71122286|NCT00320372|141750528|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||60 Month Time point||||.0009
70944543|NCT00225277|141389204|SUPERIORITY_OR_OTHER|||||||0.663||95.0||||Kaplan-Meier methodology was used to estimate the time to event for each composite endpoint. The p-value was based on a log-rank test.|Log Rank|||||||0.663
70944544|NCT03455218|141389373|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
70944545|NCT03455218|141389375|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.30
70944546|NCT03455218|141389376|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
70944547|NCT03455218|141389377|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||0.002
70944548|NCT03455218|141389378|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
70944549|NCT03455218|141389379|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
70944550|NCT03455218|141389380|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
70944551|NCT03455218|141389382|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
70944552|NCT03455218|141389383|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
71083951|NCT04878055|141673586|SUPERIORITY|||||||0.281|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared test.||At Day 21 - Please note that the total of subjects in this analysis is not 270 but 255 (n=172 in the Reparixin group and n=83 in the placebo group).||||0.281
71083952|NCT04878055|141673586|SUPERIORITY|||||||0.273|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared test.||At Day 90 - Please note that the total of subjects in this analysis is not 270 but 50 (n=33 in the Reparixin group and n=17 in the placebo group).||||0.273
70944553|NCT03455218|141389384|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||||||0.71
70944554|NCT03455218|141389385|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
70944555|NCT03455218|141389386|SUPERIORITY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
70944556|NCT03455218|141389387|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
70944557|NCT03455218|141389388|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
70944558|NCT00527514|141389396|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|one-sample t-test|||The sample size of this study was not based on the statistical power consideration and was considered as sufficient for the evaluation of the efficacy and safety of the proposed olmesartan medoxomil-based treatment regimen.||||<0.0001
70944559|NCT00527514|141389397|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|One-sample t-test|||Statistical analysis parameters apply to both the daytime and nighttime rows.||||<0.0001
70944560|NCT00527514|141389398|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|One-sample t-test|||||||<0.0001
70944561|NCT00527514|141389399|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|one-sample t-test|||||||<0.0001
70944562|NCT00527514|141389400|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|One-sample t-test|||||||<0.0001
70944563|NCT00527514|141389401|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|one-sample t-test|||||||<0.0001
70944564|NCT00812838|141389402|SUPERIORITY|||||||0.5154||||||This will be a pilot study; it was assessed that 10 subjects in each arm, for a total of 20 subjects, will allow us to determine if the therapy is effective. To allow for screen failures, 45 subjects are planned for screening.|t-test, 2 sided|||||||0.5154
70944565|NCT00812838|141389403|SUPERIORITY|||||||0.3009||||||This applies to 100 units of Botulinum Toxin Type A arm vs the Normal saline arm|t-test, 2 sided|||"This will be a pilot study; it was assessed that 10 subjects in each arm, for a total of 20 subjects, will allow us to determine if the therapy is effective. To allow for screen failures, 45 subjects are planned for screening.~This analysis pertains to both categories"||||0.3009
70944566|NCT00812838|141389404|SUPERIORITY|||||||0.0166||||||This applies to 100 units of Botulinum Toxin Type A arm vs the Normal saline arm|t-test, 2 sided|||This will be a pilot study; it was assessed that 10 subjects in each arm, for a total of 20 subjects, will allow us to determine if the therapy is effective. To allow for screen failures, 45 subjects are planned for screening.||||0.0166
70944567|NCT00812838|141389405|SUPERIORITY|||||||0.8566||||||Threshold for statistical significance was \<0.05|t-test, 2 sided|||This will be a pilot study; it was assessed that 10 subjects in each arm, for a total of 20 subjects, will allow us to determine if the therapy is effective. To allow for screen failures, 45 subjects are planned for screening.||||.8566
70944568|NCT00812838|141389406|SUPERIORITY|||||||0.0286||||||Threshold for statistical significance is \<0.05|t-test, 2 sided|||This will be a pilot study; it was assessed that 10 subjects in each arm, for a total of 20 subjects, will allow us to determine if the therapy is effective. To allow for screen failures, 45 subjects are planned for screening.||||0.0286
70944569|NCT04148521|141389407|SUPERIORITY||Odds Ratio (OR)|1.15||||0.27|TWO_SIDED|95.0|0.9|1.47|||Mixed Models Analysis|||||1.47|0.90|0.27
70944570|NCT04148521|141389408|SUPERIORITY||Odds Ratio (OR)|1.04||||0.83|TWO_SIDED|95.0|0.75|1.43|||Mixed Models Analysis|||||1.43|0.75|0.83
70944571|NCT04148521|141389409|SUPERIORITY||Odds Ratio (OR)|1.43||||0.12|TWO_SIDED|95.0|0.91|2.26|||Mixed Models Analysis|||||2.26|0.91|0.12
71083953|NCT04878055|141673587|SUPERIORITY|||||||0.047||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Wilcoxon (Mann-Whitney)|||At Day 3 - Please note that the number of subjects in this analysis is not 270 but 255||||0.047
71083954|NCT04878055|141673587|SUPERIORITY|||||||0.262|||||||Wilcoxon (Mann-Whitney)|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||||||0.262
71083955|NCT04878055|141673587|SUPERIORITY|||||||0.367|||||||Wilcoxon (Mann-Whitney)|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||At Day 14 - Please note that the number of subjects in this analysis is not 270 but 209||||0.367
71122287|NCT00320372|141750528|SUPERIORITY_OR_OTHER||MMRM Least Squares Mean|12.1009|||||TWO_SIDED|95.0|10.8979|13.3039|||||Mixed Model Repeated Measure analysis on Q-LES-Q change from baseline score (continuous var) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."||13.3039|10.8979|
71122288|NCT00320372|141750528|SUPERIORITY_OR_OTHER||MMRM Least Squares Mean|7.5964|||||TWO_SIDED|95.0|6.1327|9.0602|||||Mixed Model Repeated Measure analysis on Q-LES-Q change from baseline score (continuous var) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."||9.0602|6.1327|
71122289|NCT00320372|141750528|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."||||<.0001
71122290|NCT00320372|141750529|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficients|0.14837|||<|0.0001|TWO_SIDED|||||"Null hypothesis: There is a correlation between MADRS follow-up suicidal thoughts and baseline medical threat to life.~Alternate hypothesis: There is no correlation between MADRS follow-up suicidal thoughts and baseline medical threat to life."|Pearson Correlation Coefficients|||The statistical modeling of predictors of suicide attempts and suicidal ideations considered 15 variables, defined in the protocol a priori to determine which ones were predictive of suicide attempts and suicidal ideations. Four variables representing the baseline disease and patient factors were considered predictors of suicidality. This outcome measure presents the underlying data collected and the corresponding correlation coefficient for one of the 4 variables identified.||||<.0001
70944572|NCT04148521|141389410|SUPERIORITY||Odds Ratio (OR)|1.17||||0.51|TWO_SIDED|95.0|0.73|1.86|||Mixed Models Analysis|||||1.86|0.73|0.51
71083956|NCT04878055|141673587|SUPERIORITY|||||||0.882||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Wilcoxon (Mann-Whitney)|||At Day 21 - Please note that the number of subjects in this analysis is not 270 but 176||||0.882
71083957|NCT04878055|141673587|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||At Day 28 - Please note that the number of subjects in this analysis is not 270 but 190||||0.19
71083958|NCT04878055|141673587|SUPERIORITY|||||||0.161||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||At Day 60 - Please note that the number of subjects in this analysis is not 270 but 201||||0.161
71083959|NCT04878055|141673587|SUPERIORITY|||||||0.853|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||At Day 90 - Please note that the number of subjects in this analysis is not 270 but 18||||0.853
71122291|NCT00320372|141750530|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficients|0.14819|||<|0.0001|TWO_SIDED|||||"Null hypothesis: There is a correlation between MADRS f/u suicidal thoughts and baseline intent of suicidal gesture.~Alternate hypothesis: There is no correlation between MADRS f/u suicidal thoughts and baseline intent of suicidal gesture."|Pearson Correlation Coefficients|||The statistical modeling of predictors of suicide attempts and suicidal ideations considered 15 variables, defined in the protocol a priori to determine which ones were predictive of suicide attempts and suicidal ideations. Four variables representing the baseline disease and patient factors were considered predictors of suicidality. This outcome measure presents the underlying data collected and the corresponding correlation coefficient for one of the 4 variables identified.||||<.0001
71083960|NCT04878055|141673587|SUPERIORITY|||||||0.068|||||||Wilcoxon (Mann-Whitney)|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||At EOS - Please note that the number of subjects in this analysis is not 270 but 229||||0.068
71083961|NCT04878055|141673587|SUPERIORITY|||||||0.672|||||||Wilcoxon (Mann-Whitney)|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||At hospital discharge (HD) - Please note that the number of subjects in this analysis is not 270 but 195||||0.672
71122292|NCT00320372|141750531|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficients|0.04625||||0.0012|TWO_SIDED|||||"Null hypothesis: There is a correlation between MADRS follow-up suicidal thoughts and baseline primary diagnosis of MDE.~Alternate hypothesis: There is no correlation between MADRS follow-up suicidal thoughts and baseline primary diagnosis of MDE."|Pearson Correlation Coefficients|||The statistical modeling of predictors of suicide attempts and suicidal ideations considered 15 variables, defined in the protocol a priori to determine which ones were predictive of suicide attempts and suicidal ideations. Four variables representing the baseline disease and patient factors were considered predictors of suicidality. This outcome measure presents the underlying data collected and the corresponding correlation coefficient for one of the 4 variables identified.||||.0012
71122293|NCT00086502|141750570|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|0.73|<|0.001||95.0|-0.85|-0.54||"Model terms: treatment; baseline; prior antihyperglycemic~agent (AHA) therapy \[not on AHA, monotherapy with oral AHA, peroxisome proliferator-activated receptor (PPAR)-based combination therapy\]"|ANCOVA|||||-0.54|-0.85|<0.001
71122294|NCT00086502|141750571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.7|STANDARD_DEVIATION|30.9|<|0.001||95.0|-24.3|-11.0||Model terms: treatment; baseline; prior antihyperglycemic agent (AHA) therapy \[not on AHA, monotherapy with oral AHA, peroxisome proliferator-activated receptor (PPAR)-based combination therapy\]|ANCOVA|||||-11.0|-24.3|<0.001
71122295|NCT01304329|141750572|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|102.05|STANDARD_DEVIATION|5.4|||TWO_SIDED|90.0|98.9|105.29|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|Considered characteristic is empa plus simvastatin divided by empa alone||105.29|98.90|
71122296|NCT01304329|141750573|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|101.26|STANDARD_DEVIATION|40.4|||TWO_SIDED|90.0|80.06|128.07|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|"AUC of simvastatin~Considered characteristic is empa plus simvastatin divided by simvastatin alone"||128.07|80.06|
71122297|NCT01304329|141750573|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|104.87|STANDARD_DEVIATION|25.5|||TWO_SIDED|90.0|90.09|122.07|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|"AUC of simvastatin acid~Considered characteristic is empa plus simvastatin divided by simvastatin alone."||122.07|90.09|
71122298|NCT01304329|141750574|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|109.49|STANDARD_DEVIATION|21.1|||TWO_SIDED|90.0|96.91|123.69|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|Considered characteristic is empa plus simvastatin divided by empa alone||123.69|96.91|
71122299|NCT01304329|141750575|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|97.18|STANDARD_DEVIATION|41.7|||TWO_SIDED|90.0|76.3|123.77|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|"Cmax of simvastatin.~Considered characteristic is empa plus simvastatin divided by simvastatin alone."||123.77|76.30|
71122300|NCT01304329|141750575|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|97.27|STANDARD_DEVIATION|22.7|||TWO_SIDED|90.0|84.9|111.44|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|"Cmax of simvastatin acid.~Considered characteristic is empa plus simvastatin divided by simvastatin alone."||111.44|84.90|
71122301|NCT01304329|141750576|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|102.52|STANDARD_DEVIATION|5.8|||TWO_SIDED|90.0|99.1|106.06|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|Considered characteristic is empa plus simvastatin divided by empa alone.||106.06|99.10|
70856247|NCT00481507|141199372|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.82|||>|0.05|TWO_SIDED|95.0|0.54|1.43||Reply: Only one test was performed for the primary outcome. No covariates were entered into this model and p-value is unadjusted.|Chi-squared|The results obtained from the logistic regression are equivalent to the chi-square test with one degree of freedom.||Reply: The null hypothesis was the rates of diarrhea for Kefir vs. Placebo are not different. Post power calculation was not performed because the difference observed (21.9% vs. 18%) was less than a difference that which would be considered clinically important.||1.43|0.54|>.05
70856248|NCT00608569|141199395|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||Results were considered to be statistically significant if p\<0.05|Fisher Exact|||Fisher exact test (unstratified)||||0.133
70856249|NCT03445156|141199427|OTHER|ANCOVA||||||0.04|||||||ANCOVA|F(2, 273) = 3.16, p = .044, partial c\^2 = .023||||||0.04
70856250|NCT03445156|141199427|OTHER|ANCOVA||||||0.0001|||||||ANCOVA|F(1, 36) = 44.42||||||.0001
70856251|NCT03445156|141199428|OTHER|ANCOVA|||||<|0.001|||||||ANCOVA|F(1, 36) = 44.42||Hypothesis: Participants who played a violent FPS game were expected to have more hits to targets with heads or faces than were participants who played a nonviolent shooting game.||||<.001
71122302|NCT01304329|141750577|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|102.34|STANDARD_DEVIATION|41.7|||TWO_SIDED|90.0|80.39|130.29|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|"AUC of simvastatin.~Considered characteristic is empa plus simvastatin divided by simvastatin alone."||130.29|80.39|
71122303|NCT01304329|141750577|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|111.25|STANDARD_DEVIATION|24.8|||TWO_SIDED|90.0|95.93|129.02|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|"AUC of simvastatin acid.~Considered characteristic is empa plus simvastatin divided by simvastatin alone."||129.02|95.93|
71122304|NCT02575118|141750583|OTHER||||||<|0.05|||||||linear mixed-effects regression models|All available data, and hence data for participants with missing observations at some time points, were included in the model.||In one saliva sample collected before treatment, the BPA concentration was more than 100 times higher (11.6 ng/ml) than the mean value and more than 100 SD from the mean of the remaining 19 samples. This saliva sample was excluded from the statistical analysis because it was probably contaminated. One participant had breakfast before the sample time point 1 wk after treatment, and thus the samples collected from this participant at this time point were not included in the statistical analysis.|We used mixed effects models and all available data (also data for participants with missing observations at some time points) were included in the model. Using mixed effects models is a recognized method when there are missing data. Thus, data from all 20 individuals were used for estimations at all time points (see: Rabe-Hesketh and Skrondal. Multilevel and Longitudinal Modeling Using Stata, Volume I, Third Edition. 2012, page 279).|||<0.05
71122305|NCT02575118|141750584|OTHER||||||<|0.05|||||||linear mixed-effects regression models|All available data, and hence data for participants with missing observations at some time points, were included in the model.||One participant had breakfast before the sample time point 1 wk after treatment, and thus the samples collected from this participant at this time point were not included in the statistical analysis.|We used mixed effects models and all available data (also data for participants with missing observations at some time points), were included in the model. Using mixed effects models is a recognized method when there are missing data. Thus, data from all 20 individuals were used for estimations at all time points (see: Rabe-Hesketh and Skrondal. Multilevel and Longitudinal Modeling Using Stata, Volume I, Third Edition. 2012, page 279).|||<0.05
71122306|NCT01643876|141750585|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.5|||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: in individuals with denture stomatitis, there are no difference in the extent of palatal inflammation before and 3 months after palatal brushing. Assuming that the minimal practically important pre/post difference in the mean change score is 20 percent and the standard deviation of the distribution of the change in score is 0.8, a sample size of 44 participants is required to ensure a power of 90 % of rejecting the null hypothesis if it is indeed false.||||<0.0001
71122307|NCT01643876|141750586|SUPERIORITY_OR_OTHER||Median Difference (Net)|-57.5|||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis: in individuals with denture stomatitis, there are no difference in the number of Candida Colony-Forming Units (CFUs), before and 3 months after palatal brushing.||||<0.05
71122308|NCT02068118|141750589|SUPERIORITY||rate ratio|0.97|||=|0.8|TWO_SIDED|95.0|0.77|1.23|||negative binomial regression|||"Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up).~Deaths that occurred during hospitalization with an overnight stay were counted as two events."||1.23|0.77|=0.80
71122309|NCT02068118|141750590|SUPERIORITY||rate ratio|0.82|||=|0.18|TWO_SIDED|95.0|0.62|1.1|||negative binomial regression|||"Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up).~Deaths that occurred during hospitalization with an overnight stay were counted as two events."||1.10|0.62|=0.18
71122310|NCT02068118|141750591|SUPERIORITY||rate ratio|0.6|||=|0.02|TWO_SIDED|95.0|0.39|0.92|||negative binomial regression|||"Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up).~Deaths that occurred during hospitalization with an overnight stay were counted as two events."||0.92|0.39|=0.02
71122311|NCT02068118|141750592|SUPERIORITY||||||=|0.68|||||||Log Rank|||Time to first event compared using the log-rank test||||=0.68
71122312|NCT02068118|141750594|SUPERIORITY||||||=|0.85|||||||Log Rank|||Time to death from any cause compared using the log-rank test||||=0.85
71122313|NCT02068118|141750595|SUPERIORITY||rate ratio|0.97|||=|0.77|TWO_SIDED|95.0|0.78|1.21|||negative binomial regression|||Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up).||1.21|0.78|=0.77
70856252|NCT03445156|141199428|OTHER|ANCOVA||||||0.044|||||||ANCOVA|F(2, 273) = 3.16||Hypothesis: Participants who played a violent FPS game were expected to hit the mannequin's head more often than were participants who played either the nonviolent shooting game or the nonviolent non-shooting game Covariates: participant gender, number of guns owned over their lifetime, attitudes toward guns, and number of times they had fired a gun.||||.044
70856253|NCT03445156|141199428|OTHER|ANCOVA||||||0.17|||||||t-test, 2 sided|t(274) = 2.40||"Hypothesis: Because the nonviolent shooting game rewards other shots, participants who played a nonviolent shooting game were expected to hit the mannequin's torso more often than were participants who played the nonviolent non-shooting game.~Covariates: participant gender, number of guns owned over their lifetime, attitudes toward guns, and number of times they had fired a gun."||||0.17
71122314|NCT02068118|141750596|SUPERIORITY||rate ratio|0.97|||=|0.83|TWO_SIDED|95.0|0.74|1.27|||negative binomial regression|||"Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up).~Deaths from cardiovascular cause that occurred during a hospitalization for cardiovascular cause with an overnight stay were counted as two events."||1.27|0.74|=0.83
71122315|NCT02068118|141750597|SUPERIORITY||rate ratio|0.84|||=|0.28|TWO_SIDED|95.0|0.62|1.15|||negative binomial regression|||Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up)||1.15|0.62|=0.28
71083962|NCT04878055|141673587|SUPERIORITY|||||||0.153|||||||Wilcoxon (Mann-Whitney)|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||At end of treatment (EoT) - Please note that the number of subjects in this analysis is not 270 but 241||||0.153
71083963|NCT04878055|141673588|SUPERIORITY|Estimates are calculated using a nonparametric method for cumulative incidence function with competing risks data. The null hypothesis is that the cumulative incidence functions are identical across treatment groups and estimates are calculated taking into consideration the following competing risks: Death, reasons for discontinuation for Adverse events and patient transferred to another institution.||||||0.07|||||||Grey's test|||||||0.07
71083964|NCT04878055|141673589|SUPERIORITY|||||||0.07|||||||Gray's test|||number of patients included in the analysis=25||||0.07
71083965|NCT04878055|141673590|SUPERIORITY|Estimates are calculated using a nonparametric method for cumulative incidence function with competing risks data. The null hypothesis is that the cumulative incidence functions are identical across treatment groups and estimates are calculated taking into consideration the following competing risks: Reasons for discontinuation for Adverse events and patient transferred to another institution.||||||0.668|||||||Gray's test|||Comparison at day 28||||0.668
71083966|NCT04878055|141673591|SUPERIORITY|||||||0.668|||||||Gray's test|||Number of patients included in the analysis = 59||||0.668
71083967|NCT04878055|141673592|SUPERIORITY|||||||0.23|||||||Gray's test|||Estimates are calculated using a nonparametric method for cumulative incidence function with competing risks data. The null hypothesis is that the cumulative incidence functions are identical across treatment groups and estimates are calculated taking into consideration the following competing risks: Reasons for discontinuation for Adverse events and patient transferred to another institution.||||0.23
71083968|NCT04878055|141673593|SUPERIORITY|||||||0.444|||||||Wilcoxon (Mann-Whitney)|||day 3 - please note that the number of subjects in this analysis is not 270 but 255||||0.444
71083969|NCT04878055|141673593|SUPERIORITY|||||||0.357|||||||Wilcoxon (Mann-Whitney)|||day 7 - please note that the number of subjects in this analysis is not 270 but 246||||0.357
71083970|NCT04878055|141673593|SUPERIORITY|||||||0.484|||||||Wilcoxon (Mann-Whitney)|||day 14 - please note that the number of subjects in this analysis is not 270 but 209||||0.484
71083971|NCT04878055|141673593|SUPERIORITY|||||||0.753|||||||Wilcoxon (Mann-Whitney)|||day 21 - please note that the number of subjects in this analysis is not 270 but 176||||0.753
71083972|NCT04878055|141673593|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||day 28 - please note that the number of subjects in this analysis is not 270 but 190||||0.26
71083973|NCT04878055|141673593|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||day 60 - please note that the number of subjects in this analysis is not 270 but 201||||0.19
71083974|NCT04878055|141673593|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||day 90 - please note that the number of subjects in this analysis is not 270 but 18||||1.000
71083975|NCT04878055|141673593|SUPERIORITY|||||||0.074|||||||Wilcoxon (Mann-Whitney)|||EOS - please note that the number of subjects in this analysis is not 270 but 229||||0.074
71083976|NCT04878055|141673593|SUPERIORITY|||||||0.193|||||||two-sample Mann-Whitney U test|||EOT - please note that the number of subjects in this analysis is not 270 but 241||||0.193
71083977|NCT04878055|141673593|SUPERIORITY|||||||0.131|||||||two-sample Mann-Whitney U test|||Hospital discharge - please note that the number of subjects in this analysis is not 270 but 195||||0.131
70856254|NCT03445156|141199428|OTHER|ANCOVA||||||0.449|||||||t-test, 2 sided|t(274) = -0.76||Hypothesis: participants who played a nonviolent shooting game were expected to hit the mannequin's head less often than were participants who played the nonviolent non-shooting game Covariates: participant gender, number of guns owned over their lifetime, attitudes toward guns, and number of times they had fired a gun.||||.449
70856255|NCT03445156|141199428|OTHER|ANCOVA||||||0.645|||||||t-test, 2 sided|t(273) = -0.46||"Hypothesis: participants who played a nonviolent shooting game were expected to hit the mannequin's torso more often than were participants who played the nonviolent non-shooting game.~Covariates: participant gender, number of guns owned over their lifetime, attitudes toward guns, and number of times they had fired a gun."||||.645
70944573|NCT01723514|141389420|SUPERIORITY||LS Geometric Mean Ratio|-79.33|||<|0.001|TWO_SIDED|95.0|-87.54|-65.73|||Repeated Measures ANCOVA|||Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-65.73|-87.54|< 0.001
71083978|NCT04878055|141673594|SUPERIORITY|||||||0.997|||||||Wilcoxon (Mann-Whitney)|||at day 3 - Please note that the number of subjects in this analysis is not 270 but 155.||||0.997
71083979|NCT04878055|141673594|SUPERIORITY|||||||0.712|||||||Wilcoxon (Mann-Whitney)|||at day 7 - Please note that the number of subjects in this analysis is not 270 but 143.||||0.712
71083980|NCT04878055|141673594|SUPERIORITY|||||||0.241|||||||Wilcoxon (Mann-Whitney)|||at day 14 - Please note that the number of subjects in this analysis is not 270 but 115.||||0.241
71083981|NCT04878055|141673594|SUPERIORITY|||||||0.528|||||||Wilcoxon (Mann-Whitney)|||at day 21 - Please note that the number of subjects in this analysis is not 270 but 92.||||0.528
71083982|NCT04878055|141673594|SUPERIORITY|||||||0.814|||||||Wilcoxon (Mann-Whitney)|||at day 28 - Please note that the number of subjects in this analysis is not 270 but 106.||||0.814
71083983|NCT04878055|141673594|SUPERIORITY|||||||0.242|||||||Wilcoxon (Mann-Whitney)|||at EOT - Please note that the number of subjects in this analysis is not 270 but 115.||||0.242
71083984|NCT04878055|141673594|SUPERIORITY|||||||0.722|||||||Wilcoxon (Mann-Whitney)|||at hospital discharge (HD) - Please note that the number of subjects in this analysis is not 270 but 65.||||0.722
71083985|NCT04878055|141673595|SUPERIORITY|||||||0.053|||||||two-sample Mann-Whitney U test|||at day 3 - Please note that the number of subjects in this analysis is not 270, but it is 246.||||0.053
71083986|NCT04878055|141673595|SUPERIORITY|||||||0.245|||||||two-sample Mann-Whitney U test|||at day 7 - Please note that the number of subjects in this analysis is not 270, but it is 225.||||0.245
71083987|NCT04878055|141673595|SUPERIORITY|||||||0.067|||||||two-sample Mann-Whitney U test|||at day 14 - Please note that the number of subjects in this analysis is not 270, but it is 118.||||0.067
71083988|NCT04878055|141673595|SUPERIORITY|||||||0.051|||||||two-sample Mann-Whitney U test|||at day 21 - Please note that the number of subjects in this analysis is not 270, but it is 54.||||0.051
71083989|NCT04878055|141673595|SUPERIORITY|||||||0.684|||||||two-sample Mann-Whitney U test|||at day 28 - Please note that the number of subjects in this analysis is not 270, but it is 32.||||0.684
71083990|NCT04878055|141673595|SUPERIORITY|||||||1|||||||two-sample Mann-Whitney U test|||at EOS - Please note that the number of subjects in this analysis is not 246, but it is 14.||||1.00
71083991|NCT04878055|141673595|SUPERIORITY|||||||0.48|||||||two-sample Mann-Whitney U test|||at Day 60 - Please note that the number of subjects in this analysis is not 246, but it is 3.||||0.48
71122316|NCT02068118|141750598|SUPERIORITY||rate ratio|0.71|||=|0.078|TWO_SIDED|95.0|0.48|1.04|||negative binomial regression|||Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up)||1.04|0.48|=0.078
71083992|NCT04878055|141673595|SUPERIORITY|||||||0.638|||||||two-sample Mann-W hitney U test|||at Hospital discharge - Please note that the number of subjects in this analysis is 152.||||0.638
71083993|NCT04878055|141673595|SUPERIORITY|||||||0.137|||||||two-sample Mann-W hitney U test|||at EoT - Please note that the number of subjects in this analysis is 212.||||0.137
71083994|NCT04878055|141673596|SUPERIORITY|||||||0.399|||||||Wilcoxon (Mann-Whitney)|||at day 3 - Please note that the number of subjects in this analysis is not 270, but it is 157||||0.399
71083995|NCT04878055|141673596|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||at day 7 - Please note that the number of subjects in this analysis is not 270, but it is 139||||0.07
71083996|NCT04878055|141673596|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||at day 14 - Please note that the number of subjects in this analysis is not 270, but it is 73||||0.4
71083997|NCT04878055|141673596|SUPERIORITY|||||||0.517|||||||Wilcoxon (Mann-Whitney)|||at day 21 - Please note that the number of subjects in this analysis is not 270, but it is 23||||0.517
71083998|NCT04878055|141673596|SUPERIORITY|||||||0.445|||||||Wilcoxon (Mann-Whitney)|||at day 28 - Please note that the number of subjects in this analysis is not 270, but it is 17||||0.445
71083999|NCT04878055|141673596|SUPERIORITY|||||||0.324|||||||Wilcoxon (Mann-Whitney)|||at EoT - Please note that the number of subjects in this analysis is not 270, but it is 113||||0.324
71084000|NCT04878055|141673596|SUPERIORITY|||||||0.752|||||||Wilcoxon (Mann-Whitney)|||at Hospital discharge - Please note that the number of subjects in this analysis is not 270, but it is 67.||||0.752
71084001|NCT04878055|141673597|SUPERIORITY|||||||0.447|||||||two-sample Mann-Whitney U test|||Please note that the number of patients in this analysis is not 270 but 255, because patients who used supplement oxygen were 174 in the Reparixin group and 81 in the placebo group.||||0.447
71084002|NCT04878055|141673598|SUPERIORITY|||||||0.065||||||Comparison between treatment arms is performed by means of a Chi-squared test|Chi-squared|||At day 28 - Please note that the number of patients in this analysis is not 270 but 245, because patients requiring IMV or ECMO were 163 in the Reparixin group and 82 in the placebo group.||||0.065
70856256|NCT03445156|141199428|OTHER|Zero-order correlation||||||0.032|||||||Zero-order correlation|||Hypothesis: A positive correlation was expected between the number of violent shooting games participants listed among their three favorite video games and hits to the mannequin's head.||||.032
71084003|NCT04878055|141673598|SUPERIORITY|||||||0.072|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared test||||||0.072
71084004|NCT04878055|141673599|SUPERIORITY|||||||0.485||||||Number of subjects included in analysis: 98|two-sample Mann-Whitney U test|||||||0.485
71084005|NCT04878055|141673600|SUPERIORITY|||||||0.267|||||||two-sample Mann-Whitney U test|||Number of subjects included in analysis: 17||||0.267
71084006|NCT04878055|141673601|SUPERIORITY|||||||0.137|||||||two-sample Mann-Whitney U test|||||||0.137
71084007|NCT04878055|141673602|SUPERIORITY|||||||0.002|||||||two-sample Mann-Whitney U test|||at day 3 - Please note that the number of subjects in this analysis is 168||||0.002
71084008|NCT04878055|141673602|SUPERIORITY|||||||0.943|||||||two-sample Mann-Whitney U test|||at day 7 - Please note that the number of subjects in this analysis is not 168, but it is 146||||0.943
71084009|NCT04878055|141673602|SUPERIORITY|||||||0.88|||||||two-sample Mann-Whitney U test|||at day 14 - Please note that the number of subjects in this analysis is not 168, but it is 76||||0.88
71084010|NCT04878055|141673602|SUPERIORITY|||||||0.458|||||||Wilcoxon (Mann-Whitney)|||at day 21 - Please note that the number of subjects in this analysis is not 168, but it is 38||||0.458
71084011|NCT04878055|141673602|SUPERIORITY|||||||0.285|||||||two-sample Mann-Whitney U test|||at day 28 - Please note that the number of subjects in this analysis is not 168, but it is 23.||||0.285
71084012|NCT04878055|141673602|SUPERIORITY|||||||0.885|||||||two-sample Mann-Whitney U test|||at EOS - Please note that the number of subjects in this analysis is not 168, but it is 8||||0.885
71084013|NCT04878055|141673602|SUPERIORITY||||||=|0.583|||||||two-sample Mann-Whitney U test|||at HD - Please note that the number of subjects in this analysis is not 270, but it is 74||||= 0.583
71084014|NCT04878055|141673602|SUPERIORITY|||||||0.5|||||||two-sample Mann-Whitney U test|||at End of treatment - Please note that the number of subjects in this analysis is not 270, but it is 131.||||0.5
71084015|NCT04878055|141673603|SUPERIORITY|||||||0.005||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test|Mann-Whitney U test|||at day 3 - Please note that the number of subjects in this analysis is not 270, but it is 245||||0.005
71084016|NCT04878055|141673603|SUPERIORITY|||||||0.283||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||at day 7 - Please note that the number of subjects in this analysis is not 270, but it is 221||||0.283
71084017|NCT04878055|141673603|SUPERIORITY|||||||0.512||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||at day 14 - Please note that the number of subjects in this analysis is not 270, but it is 117||||0.512
71084018|NCT04878055|141673603|SUPERIORITY|||||||0.174|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||at day 21 - Please note that the number of subjects in this analysis is not 270, but it is 51||||0.174
71084019|NCT04878055|141673603|SUPERIORITY|at EOT - Please note that the number of subjects in this analysis is not 270, but it is 206||||||0.133|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||||||0.133
71084020|NCT04878055|141673603|SUPERIORITY|||||||0.009|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||at day 28 ± 2 - Please note that the number of subjects in this analysis is not 270, but it is 29||||0.009
71084021|NCT04878055|141673603|SUPERIORITY|||||||0.593|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||to HD - Please note that the number of subjects in this analysis is not 270, but it is 144||||0.593
71084022|NCT04878055|141673603|SUPERIORITY|||||||0.54|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||to day 60 - Please note that the number of subjects in this analysis is not 270, but it is 3||||0.540
71084023|NCT04878055|141673603|SUPERIORITY|||||||0.224|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||to EOS - Please note that the number of subjects in this analysis is not 270, but it is 13||||0.224
71084024|NCT04878055|141673604|SUPERIORITY|||||||0.68|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||to day 3 - Please note that the number of subjects in this analysis is not 270, but it is 15||||0.68
71084025|NCT04878055|141673604|SUPERIORITY|||||||0.272||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||to day 7 - Please note that the number of subjects in this analysis is not 270, but it is 13||||0.272
71084026|NCT04878055|141673604|SUPERIORITY|||||||1||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||to day 14 - Please note that the number of subjects in this analysis is not 270, but it is 13||||1.000
71084027|NCT04878055|141673604|SUPERIORITY|||||||0.903||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||to day 21 - Please note that the number of subjects in this analysis is not 270, but it is 9||||0.903
71084028|NCT04878055|141673604|SUPERIORITY|||||||0.432||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||to EOT - Please note that the number of subjects in this analysis is not 270, but it is 13||||0.432
71084029|NCT04878055|141673604|SUPERIORITY|||||||0.105||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||to day 28 - Please note that the number of subjects in this analysis is not 270, but it is 6||||0.105
71084030|NCT04878055|141673604|SUPERIORITY|||||||0.551||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||to HD - Please note that the number of subjects in this analysis is not 270, but it is 8||||0.551
71084031|NCT04878055|141673605|SUPERIORITY||Odds Ratio (OR)|0.52||||0.232|TWO_SIDED|95.0|0.178|1.522||Analysis is based on logistic regression model with proportion of patients died up to Day 60 as dependent variable, treatment, age group, gender and presence of concomitant disease at baseline as qualitative independent variables.|Regression, Logistic|||up to day 60||1.522|0.178|0.232
70856257|NCT00545129|141199450|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.45||0.569|TWO_SIDED|95.0|-1.18|0.66|||ANCOVA|||Analysis of covariance (ANCOVA) model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. Least squares (LS) mean difference, and corresponding 95% confidence interval (CI) were estimated from ANCOVA model.||0.66|-1.18|0.569
70856258|NCT00545129|141199451|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.23||0.581|TWO_SIDED|95.0|-0.6|0.34|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.34|-0.60|0.581
70856259|NCT00545129|141199451|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.32||0.795|TWO_SIDED|95.0|-0.56|0.73|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.73|-0.56|0.795
71122317|NCT02068118|141750599|SUPERIORITY||rate ratio|0.5|||=|0.023|TWO_SIDED|95.0|0.28|0.91|||negative binomial regression|||Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up)||0.91|0.28|=0.023
71122318|NCT02068118|141750600|SUPERIORITY||Hazard Ratio (HR)|0.79|||=|0.044|TWO_SIDED|95.0|0.62|0.99|||Regression, Cox|||Time to first unplanned hospital readmission for heart failure compared using multivariable Cox regression model||0.99|0.62|=0.044
71122319|NCT02068118|141750601|SUPERIORITY||Adjusted Means Difference|1.06|||=|0.17|TWO_SIDED|95.0|-2.48|4.61||Study group effect over time|Mixed Models Analysis|||ANCOVA Physical Functioning score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with physical functioning score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||4.61|-2.48|=0.17
71122320|NCT02068118|141750601|SUPERIORITY||Adjusted Means Difference|1.8|||=|0.23|TWO_SIDED|95.0|-2.61|6.21||Study group effect over time|Mixed Models Analysis|||ANCOVA Role Physical score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with role physical score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||6.21|-2.61|=0.23
71122321|NCT02068118|141750601|SUPERIORITY||Adjusted Means Difference|4.46|||=|0.5|TWO_SIDED|95.0|0.59|8.33||Study group effect over time|Mixed Models Analysis|||ANCOVA Bodily Pain score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with bodily pain score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||8.33|0.59|=0.50
71122322|NCT02068118|141750601|SUPERIORITY||Adjusted Means Difference|2.52|||=|0.19|TWO_SIDED|95.0|-0.07|5.12||Study group effect over time|Mixed Models Analysis|||ANCOVA General Health score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with general health score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||5.12|-0.07|=0.19
71122323|NCT02068118|141750601|SUPERIORITY||Adjusted Means Difference|2.38|||=|0.034|TWO_SIDED|95.0|-0.09|4.85||Study group effect over time|Mixed Models Analysis|||ANCOVA Vitality score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with vitality score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||4.85|-0.09|=0.034
71122324|NCT02068118|141750601|SUPERIORITY||Adjusted Means Difference|4.03|||=|0.025|TWO_SIDED|95.0|0.6|7.47||Study group effect over time|Mixed Models Analysis|||ANCOVA Social Functioning score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with social functioning score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||7.47|0.60|=0.025
71122325|NCT02068118|141750601|SUPERIORITY||Adjusted Means Difference|1.01|||=|0.9|TWO_SIDED|95.0|-2.79|4.81||Study group effect over time|Mixed Models Analysis|||ANCOVA Role Emotional score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with role emotional score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||4.81|-2.79|=0.90
71122326|NCT02068118|141750601|SUPERIORITY||Adjusted Means Difference|2.26|||=|0.19|TWO_SIDED|95.0|0.16|4.37||Study group effect over time|Mixed Models Analysis|||ANCOVA Mental Health score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with mental health score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||4.37|0.16|=0.19
71122327|NCT02068118|141750601|SUPERIORITY||Adjusted Means Difference|0.9|||=|0.26|TWO_SIDED|95.0|-0.48|2.28||Study group effect over time|Mixed Models Analysis|||ANCOVA Physical Component Summary (PCS) score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with PCS score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||2.28|-0.48|=0.26
71122328|NCT02068118|141750601|SUPERIORITY||Adjusted Means Difference|1.2|||=|0.17|TWO_SIDED|95.0|0.08|2.31||Study group effect over time|Mixed Models Analysis|||ANCOVA Mental Component Summary (MCS) score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with MCS score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||2.31|0.08|=0.17
71122329|NCT02068118|141750606|SUPERIORITY||||||=|0.03|||||||Log Rank|||Time to first event compared using the log-rank test||||=0.03
71122330|NCT02068118|141750607|SUPERIORITY||||||=|0.15|||||||Log Rank|||Time to first event compared using the log-rank test||||=0.15
70856260|NCT00545129|141199451|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.41||0.843|TWO_SIDED|95.0|-0.76|0.93|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.93|-0.76|0.843
71084032|NCT04878055|141673605|SUPERIORITY|Analysis is based on logistic regression model with proportion of patients died up to Day 90 as dependent variable, treatment, age group, gender and presence of concomitant disease at baseline as qualitative independent variables.|Odds Ratio (OR)|0.246||||0.158|TWO_SIDED|95.0|0.034|1.782|||Regression, Logistic|||Up to Day 90||1.782|0.034|0.158
70856261|NCT00545129|141199451|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.43||0.292|TWO_SIDED|95.0|-1.34|0.42|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.42|-1.34|0.292
70856262|NCT00545129|141199452|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.23||0.299|TWO_SIDED|95.0|-0.72|0.23|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.23|-0.72|0.299
70856263|NCT00545129|141199452|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.34||0.519|TWO_SIDED|95.0|-0.47|0.91|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.91|-0.47|0.519
71084033|NCT04878055|141673606|SUPERIORITY|Freedom from (time to) death or respiratory failure (need of invasive mechanical ventilation or ECMO or admission to ICU linked to worsening of respiratory parameters compared to baseline) up to Day 90 was performed using the same Kaplan-Meier analysis and the one-sided log-rank test that were used to test for differences between groups||||||0.33607|||||||Log Rank|||||||0.33607
70856264|NCT00545129|141199452|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.42||0.776|TWO_SIDED|95.0|-0.74|0.98|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.98|-0.74|0.776
71122331|NCT02068118|141750608|SUPERIORITY||Hazard Ratio (HR)|0.71|||=|0.02|TWO_SIDED|95.0|0.53|0.95|||Regression, Cox|||Time to first unplanned hospital readmission for heart failure compared using multivariable Cox regression model||0.95|0.53|=0.02
71122332|NCT02068118|141750609|SUPERIORITY||Hazard Ratio (HR)|0.62|||=|0.043|TWO_SIDED|95.0|0.39|0.98|||Regression, Cox|||Time to first unplanned hospital readmission for heart failure compared using multivariable Cox regression model||0.98|0.39|=0.043
71122333|NCT01515475|141750615|OTHER||Risk Difference (RD)|3.0||||0.72|TWO_SIDED|95.0|-12.0|18.0|||Barnard's Exact Test|||||18|-12|0.72
71122334|NCT01515475|141750615|OTHER||Risk Difference (RD)|-13.0||||0.14|TWO_SIDED|95.0|-31.0|4.0|||Barnard's Exact Test|||||4|-31|0.14
71122335|NCT01515475|141750623|OTHER||Mean Difference (Final Values)|0.6||||0.002|TWO_SIDED|99.0|0.11|1.09||Results are considered statistically significant if p\<0.01.|ANCOVA|||"Analysis for the more hyperopic eye, Older Cohort:~An analysis of covariance model adjusting for refractive error at enrollment was used to compare mean change in refractive error between treatment groups."||1.09|0.11|0.002
71122336|NCT01515475|141750623|OTHER||Mean Difference (Final Values)|0.58||||0.002|TWO_SIDED|99.0|0.1|1.06||Results are considered statistically significant if p\<0.01.|ANCOVA|||"Analysis for the less hyperopic eye, Older Cohort:~An analysis of covariance model adjusting for refractive error at enrollment was used to compare mean change in refractive error between treatment groups."||1.06|0.10|0.002
71122337|NCT01515475|141750623|OTHER||Mean Difference (Final Values)|0.16||||0.53|TWO_SIDED|99.0|-0.51|0.84||Results are considered statistically significant if p≤0.01.|ANCOVA|||"Analysis for the more hyperopic eye, Younger Cohort:~An analysis of covariance model adjusting for refractive error at enrollment was used to compare mean change in refractive error between treatment groups."||0.84|-0.51|0.53
70856265|NCT00545129|141199452|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.45||0.978|TWO_SIDED|95.0|-0.93|0.91|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.91|-0.93|0.978
71084034|NCT00814138|141673617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-488.0||||0.26|TWO_SIDED|95.0|-2443.4|1467.3|||Wilcoxon (Mann-Whitney)|||If a study participant terminated, their last results were pulled forward.||1467.3|-2443.4|0.26
71084035|NCT00814138|141673618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.26|TWO_SIDED|95.0|-9.7|5.8|||Wilcoxon (Mann-Whitney)|||If a study participant terminated, their last results were pulled forward.||5.8|-9.7|0.26
71084036|NCT00814138|141673619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.29|TWO_SIDED|95.0|-4.9|1.5|||t-test, 2 sided|||If a study participant terminated, their last results were pulled forward.||1.5|-4.9|0.29
71084037|NCT00814138|141673620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.28|TWO_SIDED|95.0|-6.3|1.8|||t-test, 2 sided|||If a study participant terminated, their last results were pulled forward.||1.8|-6.3|0.28
71084038|NCT00814138|141673621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.82|TWO_SIDED|95.0|-7.2|5.4|||Wilcoxon (Mann-Whitney)|||If a study participant terminated, their last results were pulled forward.||5.4|-7.2|0.82
71122338|NCT01515475|141750623|OTHER||Mean Difference (Final Values)|0.22||||0.38|TWO_SIDED|99.0|-0.43|0.86||Results are considered statistically significant if p≤0.01.|ANCOVA|||"Analysis for the less hyperopic eye, Younger Cohort:~An analysis of covariance model adjusting for refractive error at enrollment was used to compare mean change in refractive error between treatment groups."||0.86|-0.43|0.38
71084039|NCT00814138|141673622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.21|TWO_SIDED|95.0|-3.7|0.8|||t-test, 2 sided|||If a study participant terminated, their last results were pulled forward.||0.8|-3.7|0.21
71084040|NCT00814138|141673623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3||||0.09|TWO_SIDED|95.0|-7.1|0.5|||t-test, 2 sided|||If a study participant terminated, their last results were pulled forward.||0.5|-7.1|0.09
71084041|NCT02372344|141673624|SUPERIORITY_OR_OTHER||Geometric least square (LS) mean ratio|0.64|||||TWO_SIDED|95.0|0.54|0.77||||||Total EPA: Ratio of Fasting to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.77|0.54|
71084042|NCT02372344|141673624|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.71|||||TWO_SIDED|95.0|0.59|0.86||||||Total EPA: Ratio of Before meal to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.86|0.59|
71084043|NCT02372344|141673625|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.35|||||TWO_SIDED|95.0|0.27|0.47||||||Total EPA: Ratio of Fasting to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (Cmax) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.47|0.27|
71122339|NCT01515475|141750624|OTHER||Mean Difference (Final Values)|-25.0||||0.013|TWO_SIDED|99.0|-49.0|1.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||"Analysis for the more hyperopic eye:~Barnard's exact test was used to compare proportions between treatment groups."||1|-49|0.013
71122340|NCT01515475|141750624|OTHER||Hazard Ratio, log|-18.0||||0.08|TWO_SIDED|99.0|-42.0|8.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||"Analysis for the less hyperopic eye:~Barnard's exact test was used to compare proportions between treatment groups."||8|-42|0.08
71122341|NCT01515475|141750625|OTHER||Mean Difference (Final Values)|0.01||||0.22|TWO_SIDED|99.0|-0.02|0.04|||ANCOVA|||"Test for Difference in Means in Better-Seeing Eye: Older Cohort~An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups. Results are considered statistically significant if p\<0.01."||0.04|-0.02|0.22
71122342|NCT01515475|141750625|OTHER||Mean Difference (Final Values)|-0.02||||0.41|TWO_SIDED|99.0|-0.06|0.03|||ANCOVA|||"Test for Difference in Means in Worse-Seeing Eye: Older Cohort~An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups. Results are considered statistically significant if p\<0.01."||0.03|-0.06|0.41
71122343|NCT01515475|141750625|OTHER||Mean Difference (Final Values)|-0.05||||0.02|TWO_SIDED|99.0|-0.12|0.01|||ANCOVA|||"Test for Difference in Means in Better-Seeing Eye: Younger Cohort~An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups. Results are considered statistically significant if p\<0.01."||0.01|-0.12|0.02
71122344|NCT01515475|141750625|OTHER||Mean Difference (Final Values)|-0.07||||0.15|TWO_SIDED|99.0|-0.19|0.05|||ANCOVA|||"Test for Difference in Means in Worse-Seeing Eye: Younger Cohort~An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups. Results are considered statistically significant if p\<0.01."||0.05|-0.19|0.15
71122345|NCT01515475|141750626|OTHER||Mean Difference (Final Values)|-2.0||||0.51|TWO_SIDED|99.0|-18.0|13.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||Barnard's exact test was used to compare proportions between treatment groups.||13|-18|0.51
71122346|NCT01515475|141750626|OTHER||Mean Difference (Final Values)|-2.0||||0.79|TWO_SIDED|99.0|-18.0|14.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||Barnard's exact test was used to compare proportions between treatment groups.||14|-18|0.79
71122347|NCT01515475|141750627|OTHER||Mean Difference (Final Values)|-2.0||||0.51|TWO_SIDED|99.0|-18.0|13.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||Barnard's exact test was used to compare proportions between treatment groups.||13|-18|0.51
71122348|NCT01515475|141750627|OTHER||Mean Difference (Final Values)|-4.0||||0.68|TWO_SIDED|99.0|-24.0|16.0||Results are considered statistically significant if p≤0.01.|Barnard's Exact Test|||Barnard's exact test was used to compare proportions between treatment groups.||16|-24|0.68
71122349|NCT01515475|141750628|OTHER||Mean Difference (Final Values)|-0.04||||0.21|TWO_SIDED|99.0|-0.12|0.05||Results are considered statistically significant if p\<0.01|ANCOVA|||An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups.||0.05|-0.12|0.21
71122350|NCT01515475|141750628|OTHER||Mean Difference (Final Values)|-0.03||||0.25|TWO_SIDED|99.0|-0.1|0.04||Results are considered statistically significant if p≤0.01.|ANCOVA|||An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups.||0.04|-0.10|0.25
71122351|NCT01515475|141750629|OTHER||Mean Difference (Final Values)|-2.0||||0.51|TWO_SIDED|99.0|-18.0|13.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||Barnard's exact test used to compare proportions between treatment groups||13|-18|0.51
71122352|NCT01515475|141750629|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|99.0|-17.0|17.0||No p-value, because there was 0% difference||||Barnard's exact test used to compare proportions between treatment groups.||17|-17|
71122353|NCT01515475|141750630|OTHER||Mean Difference (Final Values)|0.02||||0.74|TWO_SIDED|99.0|-0.11|0.14||Results are considered statistically significant if p\<0.01.|ANCOVA|||An analysis of covariance model was used to compare mean change in stereoacuity between treatment groups. The analysis controlled for age at the 3-year visit, anisometropia at the most recent visit, and stereoacuity at enrollment.||0.14|-0.11|0.74
71122354|NCT01515475|141750630|OTHER||Mean Difference (Final Values)|-0.1||||0.15|TWO_SIDED|99.0|-0.4|0.1|||ANCOVA|||An analysis of covariance model was used to compare mean change in stereoacuity between treatment groups. The analysis controlled for age at the 3-year visit and anisometropia at the most recent visit.||0.1|-0.4|0.15
71122355|NCT01515475|141750631|OTHER||Mean Difference (Final Values)|5.0||||0.53|TWO_SIDED|99.0|-14.0|26.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||Barnard's exact test used to compare proportions between treatment groups||26|-14|0.53
71122356|NCT01515475|141750631|OTHER||Mean Difference (Final Values)|-19.0||||0.02|TWO_SIDED|99.0|-40.0|2.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||Barnard's exact test used to compare proportions between treatment groups.||2|-40|0.02
71122357|NCT01996592|141750651|OTHER||||||<|0.01||||||p-value was calculated|ANOVA|||"PROMIS -perceived stress scale was utilized (a validated test). Scoring ranges from 0-40, with the following ranges indicative of low, moderate, or high perceived stress:~0-13=low stress 14-26=moderate stress 27-40=high perceived stress"||||<0.01
71122358|NCT01996592|141750652|OTHER||||||<|0.01||||||p-value was calculated|ANOVA|||||||<0.01
71122359|NCT00130923|141750653|SUPERIORITY||difference in treatment slopes|-0.043|STANDARD_ERROR_OF_MEAN|0.021||0.054|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment slopes in a mixed model and its standard error.|||||0.054
71122360|NCT00130923|141750654|SUPERIORITY||Difference in treatment means|-0.62|STANDARD_ERROR_OF_MEAN|0.29||0.035|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.|||||.035
71122361|NCT00130923|141750655|SUPERIORITY||difference in treatment means|0.056|STANDARD_ERROR_OF_MEAN|0.099||0.57|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.|||||.57
71122362|NCT00130923|141750656|SUPERIORITY||difference in treatment means|2.65|STANDARD_ERROR_OF_MEAN|2.68||0.32|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient difference in treatment means in a mixed model and its standard error.|||||.32
71122363|NCT00130923|141750657|SUPERIORITY||difference in treatment means|0.93|STANDARD_ERROR_OF_MEAN|1.19||0.44|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.|||||.44
71122364|NCT00130923|141750658|SUPERIORITY|||||||0.003|||||||Chi-squared|Statistical test of hypothesis. Value of the Chi-squared statistic is 9.08||||||.003
71122365|NCT05028517|141750662|SUPERIORITY||ANOVA Omnibus F test|0.511||||0.602|TWO_SIDED||||||ANOVA|||||||.602
71122366|NCT05028517|141750663|SUPERIORITY||ANOVA Omnibus F test|1.245||||0.294|TWO_SIDED||||||ANOVA|||||||.294
71122367|NCT05028517|141750664|SUPERIORITY||Anova Omnibus F test|2.585||||0.039|TWO_SIDED||||||ANOVA|||||||.039
71122368|NCT05028517|141750665|SUPERIORITY||Anova Omnibus F test|2.723||||0.032|TWO_SIDED||||||ANOVA|||||||0.032
71122369|NCT05028517|141750666|SUPERIORITY||Anova Omnibus F test|0.588||||0.672|TWO_SIDED||||||ANOVA|||||||0.672
71122370|NCT05028517|141750667|SUPERIORITY||Anova Omnibus F test|2.612||||0.038|TWO_SIDED||||||ANOVA|||||||0.038
71122371|NCT05028517|141750668|SUPERIORITY||Anova Omnibus F test|0.196||||0.94|TWO_SIDED||||||ANOVA|||||||.940
70856266|NCT00545129|141199452|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.45||0.689|TWO_SIDED|95.0|-1.1|0.73|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.73|-1.10|0.689
70856267|NCT00545129|141199453|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.23||0.299|TWO_SIDED|95.0|-0.72|0.23|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.23|-0.72|0.299
71122372|NCT05028517|141750669|SUPERIORITY||Anova Omnibus F test|0.59||||0.671|TWO_SIDED||||||ANOVA|||||||.671
71122373|NCT05028517|141750670|SUPERIORITY||Anova Omnibus F test|0.896||||0.468|TWO_SIDED||||||ANOVA|||||||.468
71122374|NCT05028517|141750671|SUPERIORITY||Anova Omnibus F test|3.42||||0.01|TWO_SIDED||||||ANOVA|||||||0.01
71122375|NCT05028517|141750672|SUPERIORITY||Anova Omnibus F test|1.384||||0.257|TWO_SIDED||||||ANOVA|||||||.257
71122376|NCT05028517|141750673|SUPERIORITY||Anova Omnibus F test|1.686||||0.192|TWO_SIDED||||||ANOVA|||||||.192
71122377|NCT05028517|141750674|SUPERIORITY||Anova Omnibus F test|0.651||||0.524|TWO_SIDED||||||ANOVA|||||||.524
71122378|NCT05028517|141750675|SUPERIORITY||Anova Omnibus F test|1.32||||0.255|TWO_SIDED||||||ANOVA|||||||.255
71122379|NCT02256267|141750676|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.0771|||||TWO_SIDED|90.0|0.0671|0.0886||||||||0.0886|0.0671|
71122380|NCT02256267|141750677|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.0467|||||TWO_SIDED|90.0|0.0376|0.0581||||||||0.0581|0.0376|
71122381|NCT04557787|141750678|SUPERIORITY||Mean Difference (Final Values)|28.4||||0.001|TWO_SIDED|95.0|12.2|44.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||44.6|12.2|0.001
71122382|NCT04557787|141750678|SUPERIORITY||Mean Difference (Final Values)|28.2||||0.001|TWO_SIDED|95.0|12.0|44.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||44.4|12.0|0.001
71122383|NCT04557787|141750678|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.983|TWO_SIDED|95.0|-16.0|16.3||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||16.3|-16.0|0.983
71122384|NCT04557787|141750679|SUPERIORITY||Mean Difference (Final Values)|33.2|||<|0.001|TWO_SIDED|95.0|17.0|49.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||49.4|17.0|<0.001
70856268|NCT00545129|141199453|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.34||0.519|TWO_SIDED|95.0|-0.47|0.91|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.91|-0.47|0.519
71122385|NCT04557787|141750679|SUPERIORITY||Mean Difference (Final Values)|29.7|||<|0.001|TWO_SIDED|95.0|13.5|46.0||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||46.0|13.5|<0.001
71122386|NCT04557787|141750679|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.667|TWO_SIDED|95.0|-12.6|19.7||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||19.7|-12.6|0.667
71122387|NCT04557787|141750680|SUPERIORITY||Mean Difference (Final Values)|-3.6||||0.503|TWO_SIDED|95.0|-14.2|7.0||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||7.0|-14.2|0.503
71122388|NCT04557787|141750680|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.916|TWO_SIDED|95.0|-10.1|11.2||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||11.2|-10.1|0.916
71122389|NCT04557787|141750680|SUPERIORITY||Mean Difference (Final Values)|-4.1||||0.438|TWO_SIDED|95.0|-14.8|6.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied||6.5|-14.8|0.438
71122390|NCT04557787|141750681|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.955|TWO_SIDED|95.0|-10.3|10.9||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||10.9|-10.3|0.955
71122391|NCT04557787|141750681|SUPERIORITY||Mean Difference (Final Values)|-8.5||||0.118|TWO_SIDED|95.0|-19.2|2.2||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||2.2|-19.2|0.118
71122392|NCT04557787|141750681|SUPERIORITY||Mean Difference (Final Values)|8.8||||0.104|TWO_SIDED|95.0|-1.8|19.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||19.5|-1.8|0.104
71122393|NCT04557787|141750682|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.352|TWO_SIDED|95.0|-0.22|0.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.60|-0.22|0.352
71122394|NCT04557787|141750682|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.98|TWO_SIDED|95.0|-0.41|0.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.40|-0.41|0.980
71122395|NCT04557787|141750682|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.339|TWO_SIDED|95.0|-0.21|0.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.60|-0.21|0.339
71122396|NCT04557787|141750683|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.7|TWO_SIDED|95.0|-0.62|0.42||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.42|-0.62|0.700
71122397|NCT04557787|141750683|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.227|TWO_SIDED|95.0|-0.2|0.84||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.84|-0.20|0.227
70856269|NCT00545129|141199453|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.44||0.618|TWO_SIDED|95.0|-0.68|1.13|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.13|-0.68|0.618
71122398|NCT04557787|141750683|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.112|TWO_SIDED|95.0|-0.94|0.1||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.10|-0.94|0.112
71122399|NCT04557787|141750684|SUPERIORITY||Mean Difference (Final Values)|0.99||||0.013|TWO_SIDED|95.0|0.22|1.17||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.17|0.22|0.013
71122400|NCT04557787|141750684|SUPERIORITY||Mean Difference (Final Values)|0.73||||0.065|TWO_SIDED|95.0|-0.05|1.51||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.51|-0.05|0.065
71122401|NCT04557787|141750684|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.497|TWO_SIDED|95.0|-0.51|1.04||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.04|-0.51|0.497
71122402|NCT04557787|141750685|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.027|TWO_SIDED|95.0|0.06|0.88||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.88|0.06|0.027
71122403|NCT04557787|141750685|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.005|TWO_SIDED|95.0|0.19|1.02||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.02|0.19|0.005
71122404|NCT04557787|141750685|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.532|TWO_SIDED|95.0|-0.54|0.28||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.28|-0.54|0.532
71122405|NCT04557787|141750686|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.461|TWO_SIDED|95.0|-0.26|0.56||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.56|-0.26|0.461
71122406|NCT04557787|141750686|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.12|TWO_SIDED|95.0|-0.09|0.73||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.73|-0.09|0.120
71122407|NCT04557787|141750686|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.404|TWO_SIDED|95.0|-0.58|0.24||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.24|-0.58|0.404
71122408|NCT04557787|141750687|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.478|TWO_SIDED|95.0|-0.33|0.71||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.71|-0.33|0.478
71122409|NCT04557787|141750687|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.824|TWO_SIDED|95.0|-0.46|0.58||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.58|-0.46|0.824
71122410|NCT04557787|141750687|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.626|TWO_SIDED|95.0|-0.39|0.65||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.65|-0.39|0.626
71122411|NCT04557787|141750688|SUPERIORITY||Mean Difference (Final Values)|0.86||||0.03|TWO_SIDED|95.0|0.09|1.64||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.64|0.09|0.030
71122412|NCT04557787|141750688|SUPERIORITY||Mean Difference (Final Values)|0.88||||0.027|TWO_SIDED|95.0|0.11|1.66||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.66|0.11|0.027
70856270|NCT00545129|141199453|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.47||0.818|TWO_SIDED|95.0|-0.85|1.07|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.07|-0.85|0.818
71122413|NCT04557787|141750688|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.956|TWO_SIDED|95.0|-0.8|0.75||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.75|-0.80|0.956
71122414|NCT04557787|141750689|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.084|TWO_SIDED|95.0|-0.05|0.78||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.78|-0.05|0.084
71122415|NCT04557787|141750689|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.063|TWO_SIDED|95.0|-0.02|0.81||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.81|-0.02|0.063
70856271|NCT00545129|141199453|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.48||0.819|TWO_SIDED|95.0|-0.87|1.09||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.09|-0.87|0.819
71122416|NCT04557787|141750689|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.885|TWO_SIDED|95.0|-0.44|0.38||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.38|-0.44|0.885
71122417|NCT00259298|141750694|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for skull, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the skull from baseline to 3 months.||||0.0078
71122418|NCT00259298|141750694|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for skull, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the skull from baseline to 18 months.||||0.0078
71122419|NCT00259298|141750694|SUPERIORITY_OR_OTHER|||||||0.0313||95.0||||p-value is for skull, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the skull from baseline to 24 months.||||0.0313
71122420|NCT00259298|141750694|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for skull, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the skull from 3 months to 18 months.||||0.0078
71122421|NCT00259298|141750694|SUPERIORITY_OR_OTHER|||||||0.0156||95.0||||p-value is for skull, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the skull from 18 months to 24 months.||||0.0156
71122422|NCT00259298|141750694|SUPERIORITY_OR_OTHER|||||||0.0156||95.0||||p-value is for mandible, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the mandible from baseline to 3 months.||||0.0156
71122423|NCT00259298|141750694|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for mandible, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the mandible from baseline to 18 months.||||0.0078
71122424|NCT00259298|141750694|SUPERIORITY_OR_OTHER|||||||0.1563||95.0||||p-value is for mandible, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the mandible from baseline to 24 months.||||0.1563
71122425|NCT00259298|141750694|SUPERIORITY_OR_OTHER|||||||0.4375||95.0||||p-value is for mandible, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the mandible from 3 months to 18 months.||||0.4375
71122426|NCT00259298|141750694|SUPERIORITY_OR_OTHER|||||||0.0781||95.0||||p-value is for mandible, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the mandible from 18 months to 24 months.||||0.0781
71122427|NCT00259298|141750694|SUPERIORITY_OR_OTHER|||||||0.0371||95.0||||p-value is for spine, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the spine from baseline to 3 months.||||0.0371
71122428|NCT00259298|141750694|SUPERIORITY_OR_OTHER|||||||0.0137||95.0||||p-value is for spine, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the spine from baseline to 18 months.||||0.0137
71122429|NCT00259298|141750694|SUPERIORITY_OR_OTHER|||||||0.0547||95.0||||p-value is for spine, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the spine from baseline to 24 months.||||0.0547
71122430|NCT00259298|141750694|SUPERIORITY_OR_OTHER|||||||0.0488||95.0||||p-value is for spine, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the spine from 3 months to 18 months.||||0.0488
71122431|NCT00259298|141750694|SUPERIORITY_OR_OTHER|||||||0.3594||95.0||||p-value is for spine, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the spine from 18 months to 24 months.||||0.3594
71122432|NCT00259298|141750694|SUPERIORITY_OR_OTHER|||||||0.0488||95.0||||p-value is for pelvis, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the pelvis from baseline to 3 months.||||0.0488
71122433|NCT00259298|141750694|SUPERIORITY_OR_OTHER|||||||0.1055||95.0||||p-value is for pelvis, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the pelvis from baseline to 18 months.||||0.1055
71122434|NCT00259298|141750694|SUPERIORITY_OR_OTHER|||||||0.9102||95.0||||p-value is for pelvis, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the pelvis from baseline to 24 months.||||0.9102
71122435|NCT00259298|141750694|SUPERIORITY_OR_OTHER|||||||0.1934||95.0||||p-value is for pelvis, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the pelvis from 3 months to 18 months.||||0.1934
71122436|NCT00259298|141750694|SUPERIORITY_OR_OTHER|||||||0.1641||95.0||||p-value is for pelvis, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the pelvis from 18 months to 24 months.||||0.1641
71122437|NCT00259298|141750694|SUPERIORITY_OR_OTHER|||||||0.0137||95.0||||p-value is for upper extremities, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from baseline to 3 months.||||0.0137
71122438|NCT00259298|141750694|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value is for upper extremities, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from baseline to 18 months.||||0.0020
71122439|NCT00259298|141750694|SUPERIORITY_OR_OTHER|||||||0.0039||95.0||||p-value is for upper extremities, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from baseline to 24 months.||||0.0039
71122440|NCT00259298|141750694|SUPERIORITY_OR_OTHER|||||||0.0273||95.0||||p-value is for upper extremities, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from 3 months to 18 months.||||0.0273
71122441|NCT00259298|141750694|SUPERIORITY_OR_OTHER|||||||0.0547||95.0||||p-value is for upper extremities, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from 18 months to 24 months.||||0.0547
70856272|NCT00545129|141199454|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.34||0.906|TWO_SIDED|95.0|-0.66|0.74|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.74|-0.66|0.906
71122442|NCT00259298|141750694|SUPERIORITY_OR_OTHER|||||||0.0195||95.0||||p-value is for lower extremities, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from baseline to 3 months.||||0.0195
71122443|NCT00259298|141750694|SUPERIORITY_OR_OTHER|||||||0.0059||95.0||||p-value is for lower extremities, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from baseline to 18 months.||||0.0059
71122444|NCT00259298|141750694|SUPERIORITY_OR_OTHER|||||||0.5703||95.0||||p-value is for lower extremities, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from baseline to 24 months.||||0.5703
71122445|NCT00259298|141750694|SUPERIORITY_OR_OTHER|||||||0.1934||95.0||||p-value is for lower extremities, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from 3 months to 18 months.||||0.1934
70856273|NCT00545129|141199454|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.44||0.906|TWO_SIDED|95.0|-0.95|0.85|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.85|-0.95|0.906
70856274|NCT00545129|141199454|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.5||0.613|TWO_SIDED|95.0|-0.78|1.29|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.29|-0.78|0.613
71122446|NCT00259298|141750694|SUPERIORITY_OR_OTHER|||||||0.0039||95.0||||p-value is for lower extremities, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from 18 months to 24 months.||||0.0039
71122447|NCT00259298|141750694|SUPERIORITY_OR_OTHER|||||||0.0039||95.0||||p-value is for whole body, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the whole body from baseline to 3 months.||||0.0039
71084044|NCT02372344|141673625|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.44|||||TWO_SIDED|95.0|0.33|0.59||||||Total EPA: Ratio of Before meal to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (Cmax) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.59|0.33|
71084045|NCT02372344|141673625|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.46|||||TWO_SIDED|95.0|0.36|0.57||||||Total DHA: Ratio of Fasting to After meal. Primary comparisons for total DHA were based on a linear mixed-effect model. This model included log-transformed PK parameter (Cmax) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.57|0.36|
71084046|NCT02372344|141673625|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.57|||||TWO_SIDED|95.0|0.45|0.71||||||Total DHA: Ratio of Before meal to After meal. Primary comparisons for total DHA were based on a linear mixed-effect model. This model included log-transformed PK parameter (Cmax) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.71|0.45|
71084047|NCT02372344|141673626|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.56|||||TWO_SIDED|95.0|0.45|0.69||||||Total EPA: Ratio of Fasting to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC0-72) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.69|0.45|
71084048|NCT02372344|141673626|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.55||||||95.0|0.44|0.69||||||Total EPA: Ratio of Before Meal to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC0-72) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.69|0.44|
71084049|NCT02372344|141673626|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.87|||||TWO_SIDED|95.0|0.73|1.04||||||Total DHA: Ratio of Fasting to After meal. Primary comparisons for total DHA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC0-72) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||1.04|0.73|
71084050|NCT02372344|141673626|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.86|||||TWO_SIDED|95.0|0.72|1.02||||||Total DHA: Ratio of Before meal to After meal. Primary comparisons for total DHA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC0-72) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||1.02|0.72|
71084051|NCT02258217|141673629|EQUIVALENCE|"We created a difference in ADL score variable. This was calculated as follows:~ADL score (new relapse) - ADL score (after treatment of current relapse)~This difference score was tested for equivalence to 0 or not."|Mean Difference (Final Values)|-1.8|STANDARD_DEVIATION|3.03||0.003|TWO_SIDED|95.0|-2.9|-0.66|||Paired t-test, 2 sided|||"We compared the two ADL scores measured in the same arm at different timepoints (new \& after treatment).~Null Hypothesis = Difference in means is = 0 Alternate Hypothesis = Difference in means is not = 0~We used the Paired t-test to compare the pre - post ADL scores."||-0.66|-2.9|0.003
71084052|NCT02258217|141673630|EQUIVALENCE|"We created a difference in ADL score variable. This was calculated as follows:~ADL score (new relapse) - ADL score (after treatment of current relapse) This difference score was tested for equivalence to 0 or not."|Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|3.09||0.99|TWO_SIDED|95.0|-1.22|1.22|||Paired t-test, 2 sided|||"We compared the two RSH scores measured in the same arm at different time points (new \& after treatment).~Null Hypothesis = Difference in means is = 0 Alternate Hypothesis = Difference in means is not = 0 We used the Paired t-test to compare the pre - post RSH scores."||1.22|-1.22|0.99
71084053|NCT02258217|141673632|EQUIVALENCE|"We created a difference in PCS score variable. This was calculated as follows:~PCS score (new relapse) - PCS score (after treatment of current relapse). This difference score was tested for equivalence to 0 or not."|Mean Difference (Final Values)|-1.9|STANDARD_DEVIATION|4.42||0.03|TWO_SIDED|95.0|-3.67|-0.18|||Paired t-test, two sided|||"We compared the two PCS scores measured in the same arm at different timepoints (new \& after treatment).~Null Hypothesis = Difference in means is = 0 Alternate Hypothesis = Difference in means is not = 0 We used the Paired t-test to compare the pre - post PCS scores."||-0.18|-3.67|0.03
71084054|NCT02258217|141673633|EQUIVALENCE|"We created a difference in MSIS physical score variable. This was calculated as follows:~MSIS physical score (new relapse) - MSIS physical score (after treatment of current relapse)~This difference score was tested for equivalence to 0 or not."|Median Difference (Final Values)|2.5||||0.19|TWO_SIDED||||||Wilcoxon Signed Rank test|||"We compared the two MSIS physical scores measured in the same arm at different timepoints (new relapse \& after treatment of relapse).~Null Hypothesis = Difference in medians is = 0 Alternate Hypothesis = Difference in medians is not = 0~We used the Wilcoxon Signed rank test to compare the pre - post MSIS physical scores."||||0.19
71084055|NCT02258217|141673634|EQUIVALENCE|"We created a difference in MSIS psychological score variable. This was calculated as follows:~MSIS psychological score (new relapse) - MSIS psychological score (after treatment of current relapse)~This difference score was tested for equivalence to 0 or not."|Mean Difference (Final Values)|3.1|STANDARD_DEVIATION|6.3||0.01|TWO_SIDED|95.0|0.74|5.45|||Paired t-test, 2 sided|||"We compared the two MSIS psychological scores measured in the same arm at different timepoints (new relapse \& after treatment of relapse).~Null Hypothesis = Difference in means is = 0 Alternate Hypothesis = Difference in means is not = 0~We used the Paired t-test to compare the pre - post MSIS psychological scores."||5.45|0.74|0.01
71122448|NCT00259298|141750694|SUPERIORITY_OR_OTHER|||||||0.5703||95.0||||p-value is for whole body, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the whole body from baseline to 24 months.||||0.5703
71122449|NCT00259298|141750694|SUPERIORITY_OR_OTHER|||||||0.0273||95.0||||p-value is for whole body, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the whole body from 3 months to 18 months.||||0.0273
71122450|NCT00259298|141750694|SUPERIORITY_OR_OTHER|||||||0.0039||95.0||||p-value if for whole body, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the whole body from 18 months to 24 months.||||0.0039
71122451|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.0098||95.0||||p-value is for whole skeleton, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from baseline to 3 months.||||0.0098
71122452|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.0039||95.0||||p-value is for whole skeleton, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from baseline to 18 months.||||0.0039
71122453|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.6523||95.0||||p-value is for whole skeleton, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from baseline to 24 months.||||0.6523
71122454|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.1641||95.0||||p-value is for whole skeleton, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from 3 months to 18 months.||||0.1641
71122455|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for whole skeleton, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from 18 months to 24 months.||||0.0078
71122456|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for skull, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the skull from baseline to 3 months.||||0.0078
71122457|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for skull, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the skull from baseline to 18 months.||||0.0078
71122458|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.0781||95.0||||p-value is for skull, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal uptake of 99m Tc-MDP in the skull from baseline to 24 months.||||0.0781
71122459|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for skull, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the skull from 3 months to 18 months.||||0.0078
71122460|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.0156||95.0||||p-value is for skull, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the skull from 18 months to 24 months.||||0.0156
71122461|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.0391||95.0||||p-value is for mandible, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the mandible from baseline to 3 months.||||0.0391
71122462|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.0313||95.0||||p-value is for mandible, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the mandible from baseline to 18 months.||||0.0313
71122463|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.2969||95.0||||p-value is for mandible, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the mandible from baseline to 24 months.||||0.2969
71122464|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.5625||95.0||||p-value is for mandible, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the mandible from 3 months to 18 months.||||0.5625
71122465|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.0469||95.0||||p-value is for mandible, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the mandible from 18 months to 24 months.||||0.0469
71122466|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.1934||95.0||||p-value is for spine, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the spine from 3 months to 18 months.||||0.1934
71122467|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.2324||95.0||||p-value is for spine, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the spine from baseline to 3 months.||||0.2324
71122468|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.0645||95.0||||p-value is for spine, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the spine from baseline to 18 months.||||0.0645
71122469|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.0273||95.0||||p-value is for spine, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal uptake of 99m Tc-MDP in the spine from baseline to 24 months.||||0.0273
71122470|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.7344||95.0||||p-value is for spine, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the spine from 18 months to 24 months.||||0.7344
71122471|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.1934||95.0||||p-value is for pelvis, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the pelvis from baseline to 3 months.||||0.1934
71122472|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.7695||95.0||||p-value is for pelvis, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the pelvis from baseline to 18 months.||||0.7695
71122473|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.6523||95.0||||p-value is for pelvis, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the pelvis from baseline to 24 months.||||0.6523
71122474|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.2324||95.0||||p-value is for pelvis, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the pelvis from 3 months to 18 months.||||0.2324
70856275|NCT00545129|141199454|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.46||0.988|TWO_SIDED|95.0|-0.95|0.94|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.94|-0.95|0.988
71122475|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.6523||95.0||||p-value is for pelvis, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the pelvis from 18 months to 24 months.||||0.6523
71122476|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.0098||95.0||||p-value is for upper extremities, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the upper extremities from baseline to 3 months.||||0.0098
70856276|NCT00545129|141199454|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.47||0.922|TWO_SIDED|95.0|-1.01|0.92|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.92|-1.01|0.922
70856277|NCT00545129|141199455|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.4||0.655|TWO_SIDED|95.0|-1.03|0.66|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.66|-1.03|0.655
70856278|NCT00545129|141199455|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.44||0.897|TWO_SIDED|95.0|-0.85|0.96|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.96|-0.85|0.897
70856279|NCT00545129|141199455|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.51||0.798|TWO_SIDED|95.0|-0.93|1.2|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.20|-0.93|0.798
71122477|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value is for upper extremities, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the upper extremities from baseline to 18 months.||||0.0020
71122478|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.0039||95.0||||p-value is for upper extremities, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the upper extremities from baseline to 24 months.||||0.0039
71122479|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.0273||95.0||||p-value is for upper extremities, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the upper extremities from 3 months to 18 months.||||0.0273
71122480|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.3594||95.0||||p-value is for upper extremities, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the upper extremities from 18 months to 24 months.||||0.3594
71122481|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.0371||95.0||||p-value is for lower extremities, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the lower extremities from baseline to 3 months.||||0.0371
71122482|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.0098||95.0||||p-value is for lower extremities, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the lower extremities from baseline to 18 months.||||0.0098
71122483|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.4609||95.0||||p-value is for lower extremities, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the lower extremities from baseline to 24 months.||||0.4609
71122484|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.1934||95.0||||p-value is for lower extremities, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the lower extremities from 3 months to 18 months.||||0.1934
70856280|NCT00545129|141199455|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.51||0.672|TWO_SIDED|95.0|-0.83|1.27|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.27|-0.83|0.672
71122485|NCT00259298|141750695|SUPERIORITY_OR_OTHER|||||||0.0273||95.0||||p-value is for lower extremities, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the lower extremities from 18 months to 24 months.||||0.0273
71122486|NCT00259298|141750696|SUPERIORITY_OR_OTHER|||||||1||95.0||||p-value is for focal change, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in focal skeletal uptake of 99m Tc-MDP from baseline to 3 months.||||1.0
71122487|NCT00259298|141750696|SUPERIORITY_OR_OTHER|||||||1||95.0||||p-value is for focal change, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in focal skeletal uptake of 99m Tc-MDP from baseline to 18 months.||||1.0
71122488|NCT00259298|141750698|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value is for change at 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in whole skeletal plasma clearance of 99m Tc-MDP from baseline to 18 months.||||0.0020
71122489|NCT01969500|141750710|SUPERIORITY||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|3.81||0.85|TWO_SIDED|95.0|-8.37|6.96|||Linear mixed effects model||Mean difference (Intervention Arm - TAU) in change from baseline to 12 weeks|||6.96|-8.37|.85
71122490|NCT01969500|141750711|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|1.67||0.44|TWO_SIDED|95.0|-4.66|2.06|||Linear mixed effects model||Mean difference (Intervention Arm - TAU) in change from baseline to 12 weeks|||2.06|-4.66|.44
71122491|NCT00613080|141750714|SUPERIORITY_OR_OTHER||Proportion (reported as percentage)|51.0||||0.93|TWO_SIDED||||||Chi-squared|||This study was designed for a one-sided chi-square test to detect at least 12% reduction in the 40% rate of ≥ grade 2 treatment-related preoperative GI AEs from the conventional radiotherapy / capecitabine /oxaliplatin arm of study RTOG-0247 (NCT00081289) with 80% power and a one-sided type I error rate of 0.10.||||0.93
71122492|NCT02726880|141750738|SUPERIORITY||F|1.13||||0.296|TWO_SIDED||||||ANCOVA|Number of days of gaming in the past week, measured at baseline, is included as a covariate in the model.||||||.296
71122493|NCT03553498|141750746|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
71122494|NCT03553498|141750747|SUPERIORITY|||||||0.989|||||||Chi-squared|||||||0.989
71122495|NCT03553498|141750748|SUPERIORITY|||||||0.414|||||||Chi-squared|||||||0.414
71122496|NCT03553498|141750749|SUPERIORITY|||||||0.153|||||||Chi-squared|||||||0.153
71122497|NCT02741570|141750752|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0469|TWO_SIDED|97.51|0.59|1.03|||Log Rank|stratified regular log-rank test||||1.03|0.59|0.0469
70856281|NCT00545129|141199455|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.48||0.243|TWO_SIDED|95.0|-1.56|0.41|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.41|-1.56|0.243
70856282|NCT00545129|141199456|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.41||0.445|TWO_SIDED|95.0|-1.16|0.52|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.52|-1.16|0.445
71084056|NCT02258217|141673635|EQUIVALENCE|"We created a difference in EDSS score variable. This was calculated as follows:~EDSS score (new relapse) - EDSS score (after treatment of current relapse)~This difference score was tested for equivalence to 0 or not."|Median Difference (Final Values)|0.0||||0.23|TWO_SIDED||||||Wilcoxon Signed Rank test||The interquartile range for the median difference in EDSS scores is 0.0 to 0.5|"We compared the two EDSS scores measured in the same arm at different timepoints (new relapse \& after treatment of relapse).~Null Hypothesis = Difference in medians is = 0 Alternate Hypothesis = Difference in medians is not = 0~We used the Wilcoxon Signed rank test to compare the pre - post EDSS scores."||||0.23
71084057|NCT02258217|141673636|EQUIVALENCE|"We created a difference in SAGE score variable. This was calculated as follows:~SAGE score (new relapse) - SAGE score (after treatment of current relapse)~This difference score was tested for equivalence to 0 or not."|Median Difference (Final Values)|0.0||||0.44|TWO_SIDED||||||Wilcoxon Signed Rank test||The interquartile range for the difference in medians is -1 to 0.|"We compared the two SAGE scores measured in the same arm at different time points (new relapse \& after treatment of relapse).~Null Hypothesis = Difference in medians is = 0 Alternate Hypothesis = Difference in medians is not = 0~We used the Wilcoxon Signed rank test to compare the pre - post SAGE scores."||||0.44
71084058|NCT00447772|141673687|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.322|||=|0.2552|TWO_SIDED|95.0|-0.877|0.233|||ANCOVA||The comparative analysis is based on adjusted means data.|An analysis of covariance (ANCOVA) model included the baseline total Tsui score (patient in sitting position) as covariate and the main type of CD as between-group factor (due to non-significance the interaction between baseline total Tsui score and the main type of CD was removed from the model).||0.233|-0.877|=0.2552
71084059|NCT00875563|141673698|NON_INFERIORITY_OR_EQUIVALENCE|An exact test method (Sidik K. 2003, Statistics in Medicine 22: 265-278) for matched controls was used, at a type I error rate of 0.05 and a non-inferiority margin of 10%. 38 pairs of patients were determined necessary, and the power was calculated to be 0.92.||||||0.02|TWO_SIDED||||||Exact test for matched pairs|||Patients treated with the Zenith® Fenestrated AAA Endovascular Graft were compared with matched patients treated with the Zenith® AAA Endovascular Graft.||||0.02
71084060|NCT02849743|141673721|OTHER||Least Means Square|-0.5||||0.92|TWO_SIDED||||||Regression, Linear|||||||0.92
71084061|NCT02849743|141673722|OTHER||Regression Coefficient|-15784.0||||0.57|TWO_SIDED||||||Regression, Linear|||||||0.57
71084062|NCT02849743|141673723|OTHER||Regression Coefficient|48.0||||0.21|TWO_SIDED||||||Mixed Models Analysis|||||||0.21
71084063|NCT02849743|141673724|OTHER||Regression Coefficient|-2.8||||0.55|TWO_SIDED||||||Regression, Linear|||||||0.55
71084064|NCT02849743|141673725|OTHER||Regression Coefficient|1.2||||0.86|TWO_SIDED||||||Regression, Linear|||||||0.86
71084065|NCT02849743|141673726|OTHER||Regression Coefficient|2.4||||0.88|TWO_SIDED||||||Regression, Linear|||||||0.88
71084066|NCT02849743|141673727|OTHER||Regression Coefficient|-0.02||||0.5|TWO_SIDED||||||Regression, Linear|||||||0.50
71084067|NCT02849743|141673728|OTHER||Regression Coefficient|-0.02||||0.49|TWO_SIDED||||||Regression, Linear|||||||0.49
71084068|NCT02849743|141673730|OTHER||Regression Coefficient|-0.7||||0.68|TWO_SIDED||||||Regression, Linear|||||||0.68
71084069|NCT02849743|141673731|OTHER||Regression Coefficient|-0.6||||0.52|TWO_SIDED||||||Regression, Linear|||||||0.52
71084070|NCT02849743|141673732|OTHER||Regression Coefficient|-0.2||||0.91|TWO_SIDED||||||Regression, Linear|||Neuro-QoL - Anxiety||||0.91
71084071|NCT02849743|141673732|OTHER||Regression Coefficient|-0.2||||0.91|TWO_SIDED||||||Regression, Linear|||Neuro-QoL - Depression||||0.91
71084072|NCT02849743|141673732|OTHER||Regression Coefficient|4.7||||0.04|TWO_SIDED||||||Regression, Linear|||Neuro-QoL - Cognition||||0.04
71084073|NCT02849743|141673732|OTHER||Regression Coefficient|2.3||||0.36|TWO_SIDED||||||Regression, Linear|||Neuro-QoL - Social Function||||0.36
71084074|NCT02849743|141673733|OTHER||Regression Coefficient|0.05||||0.64|TWO_SIDED||||||Regression, Linear|||||||0.64
71084075|NCT02849743|141673734|OTHER||Regression Coefficient|0.05||||0.83|TWO_SIDED||||||Regression, Linear|||||||0.83
71084076|NCT04607135|141673763|OTHER|||||||0.0003||||||F-statistic = 11.71|Welch's ANOVA|||||||0.0003
71084077|NCT04607135|141673763|OTHER|||||||0.002||||||q-statistic = 6.74|Games-Howell post-hoc test|||||||0.002
71084078|NCT04607135|141673763|OTHER|||||||0.24||||||q-statistic = 2.34|Games-Howell post-hoc test|||||||0.24
71084079|NCT04607135|141673763|OTHER|||||||0.35||||||q-statistic = 2.04|Games-Howell post-hoc test|||||||0.35
71084080|NCT04607135|141673764|OTHER|||||||0.99|||||||Kruskal-Wallis|||||||0.99
71084081|NCT04607135|141673765|OTHER|||||||0.74|||||||Kruskal-Wallis|||||||0.74
71084082|NCT00327717|141673781|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||ANOVA|||||||0.028
71084083|NCT00327717|141673782|SUPERIORITY_OR_OTHER|||||||0.253||95.0|||||ANOVA|||||||0.253
71084084|NCT00327717|141673783|SUPERIORITY_OR_OTHER|||||||0.211||95.0|||||ANOVA|||||||0.211
71084085|NCT00327717|141673784|SUPERIORITY_OR_OTHER|||||||0.516||95.0|||||ANOVA|||||||0.516
71084086|NCT00327717|141673785|SUPERIORITY_OR_OTHER|||||||0.044|||||||X^2 test|||||||0.044
71084087|NCT00327717|141673786|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||X^2 test|||||||0.090
71122498|NCT02741570|141750753|SUPERIORITY||Cox Proportional Hazard|0.95||||0.4951|TWO_SIDED|97.9|0.8|1.13|||Log Rank|stratified regular log-rank test||||1.13|0.80|0.4951
71122499|NCT02741570|141750754|SUPERIORITY||Cox Proportional Hazard|0.8|||||TWO_SIDED|95.0|0.68|0.95||||||||0.95|0.68|
71122500|NCT02741570|141750755|SUPERIORITY||Cox Proportional Hazard|1.4|||||TWO_SIDED|95.0|1.19|1.63|||||All Randomized Participants|||1.63|1.19|
71122501|NCT02741570|141750755|SUPERIORITY||Cox Proportional Hazard|1.0|||||TWO_SIDED|95.0|0.77|1.3|||||All Randomized PD-L1 CPS \>= 20 Participants|||1.30|0.77|
71122502|NCT02741570|141750758|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.6|0.97||||||||0.97|0.60|
71122503|NCT02741570|141750759|SUPERIORITY||Cox Proportional Hazard|0.94|||||TWO_SIDED|95.0|0.82|1.08||||||||1.08|0.82|
71122504|NCT02700165|141750775|OTHER||sucess proportion|78.6|||||TWO_SIDED|95.0|49.2|95.3|||||Independent physician reviewers correctly identified 13/14, 11/14 and 10/14, respectively for an overall percentage of correct identification of 34/42 or 81%. Two of three reviewers correctly identified 11/14 (78.6%) photos.|||95.3|49.2|
71122505|NCT02011490|141750779|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|5.42|||||TWO_SIDED|90.0|4.12|7.11|||||Difference in least squares means of log-transformed data (severe renal impaired - healthy) was back transformed to geometric least squares mean ratio (severe renal impaired/healthy)|Log-transformed plasma values were modeled using an analysis of variance (ANOVA) linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect||7.11|4.12|
71122506|NCT02011490|141750779|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|2.42|||||TWO_SIDED|90.0|1.84|3.17|||||Difference in least squares means of log-transformed data (moderate renal impaired - healthy) was back transformed to geometric least squares mean ratio (moderate renal impaired/healthy)|Log-transformed plasma values were modeled using an ANOVA linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect||3.17|1.84|
71084088|NCT00327717|141673787|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||X^2 test|||||||0.090
71084089|NCT00327717|141673788|SUPERIORITY_OR_OTHER|||||||0.162||95.0|||||X^2 test|||||||0.162
71084090|NCT00327717|141673789|SUPERIORITY_OR_OTHER|||||||0.678||95.0|||||X^2 test|||||||0.678
71084091|NCT01509612|141673798|SUPERIORITY|||||||0.397|||||||t-test, 2 sided|||||||0.397
71084092|NCT01509612|141673799|SUPERIORITY|||||||0.02|||||||Chi-squared|||Only those groups were compared who received an intervention||||0.02
71084093|NCT00627926|141673818|SUPERIORITY_OR_OTHER||Difference in percentage|23.0|||||TWO_SIDED|95.0|15.9|30.0||||||||30.0|15.9|
71084094|NCT00627926|141673818|SUPERIORITY_OR_OTHER||Difference in percentage|29.2|||||TWO_SIDED|95.0|22.4|36.1||||||||36.1|22.4|
71084095|NCT00627926|141673819|SUPERIORITY_OR_OTHER||Difference in percentage|57.1|||||TWO_SIDED|95.0|51.4|62.8||||||||62.8|51.4|
71084096|NCT00627926|141673819|SUPERIORITY_OR_OTHER||Difference in percentage|58.4|||||TWO_SIDED|95.0|52.7|64.0||||||||64.0|52.7|
71084097|NCT00627926|141673820|SUPERIORITY_OR_OTHER||Difference in percentage|48.8|||||TWO_SIDED|95.0|43.0|54.6||||||||54.6|43.0|
71084098|NCT00627926|141673820|SUPERIORITY_OR_OTHER||Difference in percentage|50.4|||||TWO_SIDED|95.0|44.6|56.2||||||||56.2|44.6|
71084099|NCT00627926|141673821|SUPERIORITY_OR_OTHER||Difference in percentage|35.7|||||TWO_SIDED|95.0|29.0|42.4||||||||42.4|29.0|
71084100|NCT00627926|141673821|SUPERIORITY_OR_OTHER||Difference in percentage|37.5|||||TWO_SIDED|95.0|30.9|44.1||||||||44.1|30.9|
71084101|NCT00627926|141673822|SUPERIORITY_OR_OTHER||Difference in percentage|17.6|||||TWO_SIDED|95.0|11.2|24.0||||||||24.0|11.2|
71084102|NCT00627926|141673822|SUPERIORITY_OR_OTHER||Difference in percentage|23.1|||||TWO_SIDED|95.0|17.0|29.2||||||||29.2|17.0|
71084103|NCT00627926|141673823|SUPERIORITY_OR_OTHER||Difference in percentage|25.5|||||TWO_SIDED|95.0|18.5|32.4||||||||32.4|18.5|
71084104|NCT00627926|141673823|SUPERIORITY_OR_OTHER||Difference in percentage|31.2|||||TWO_SIDED|95.0|24.4|37.9||||||||37.9|24.4|
71084105|NCT00627926|141673824|SUPERIORITY_OR_OTHER||Difference in percentage|25.2|||||TWO_SIDED|95.0|18.2|32.2||||||||32.2|18.2|
71084106|NCT00627926|141673824|SUPERIORITY_OR_OTHER||Difference in percentage|31.7|||||TWO_SIDED|95.0|24.9|38.5||||||||38.5|24.9|
71084107|NCT00627926|141673829|SUPERIORITY_OR_OTHER||Difference in percentage|24.9|||||TWO_SIDED|95.0|17.9|31.9||||||SVR Protocol Defined: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA between end of treatment visit (up to Week 48) and 24 weeks after last planned dose (up to Week 72).||31.9|17.9|
71084108|NCT00627926|141673829|SUPERIORITY_OR_OTHER||Difference in percentage|30.9|||||TWO_SIDED|95.0|24.1|37.7||||||SVR Protocol Defined: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA between end of treatment visit (up to Week 48) and 24 weeks after last planned dose (up to Week 72).||37.7|24.1|
71084109|NCT00627926|141673829|SUPERIORITY_OR_OTHER||Difference in percentage|25.7|||||TWO_SIDED|95.0|18.8|32.6||||||SVR FDA Guidance: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment. Analysis was based only on the HCV RNA assessment in visit window (+/-2 weeks); if there were more than 1 assessment in the window, the last measurement was used.||32.6|18.8|
71084110|NCT00627926|141673829|SUPERIORITY_OR_OTHER||Difference in percentage|32.5|||||TWO_SIDED|95.0|25.9|39.2||||||SVR FDA Guidance: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment. Analysis was based only on the HCV RNA assessment in visit window (+/-2 weeks); if there were more than 1 assessment in the window, the last measurement was used.||39.2|25.9|
71084111|NCT02797678|141673870|SUPERIORITY|||||||0.061|||||||paired t-test|||||||0.061
71084112|NCT02797678|141673873|SUPERIORITY|||||||0.301|||||||paired t-test|||||||0.301
71084113|NCT01852513|141673882|SUPERIORITY|||||||0.391|||||||t-test, 2 sided|||||||0.391
71084114|NCT01852513|141673883|SUPERIORITY|||||||0.789|||||||t-test, 2 sided|||||||0.789
71084115|NCT01852513|141673884|SUPERIORITY|||||||0.778|||||||t-test, 2 sided|||||||0.778
71084116|NCT02686164|141673891|OTHER||Geometric Mean Ratio|0.914|||||TWO_SIDED|90.0|0.85|0.983||||||AUC(0-24) of Midazolam: Cycle 1 Day 1, Lenvatinib (single-dose) + Midazolam Versus (vs.) Cycle 1 Day -3, Midazolam||0.983|0.850|
71084117|NCT02686164|141673891|OTHER||Geometric Mean Ratio|1.148|||||TWO_SIDED|90.0|0.938|1.404||||||AUC(0-24) of Midazolam: Cycle 1 Day 14, Lenvatinib (steady state) + Midazolam vs. Cycle 1 Day -3, Midazolam||1.404|0.938|
71084118|NCT02686164|141673891|OTHER||Geometric Mean Ratio|1.12|||||TWO_SIDED|90.0|0.94|1.335||||||AUC(0-24) of 1'-hydroxy midazolam: Cycle 1 Day 1, Lenvatinib (single-dose) + Midazolam vs. Cycle 1 Day -3, Midazolam||1.335|0.940|
71084119|NCT02686164|141673891|OTHER||Geometric Mean Ratio|1.199|||||TWO_SIDED|90.0|1.057|1.36||||||AUC(0-24) of 1'-hydroxy midazolam: Cycle 1 Day 14, Lenvatinib (steady-state) + Midazolam vs.Cycle 1 Day -3, Midazolam||1.360|1.057|
71084120|NCT02686164|141673892|OTHER||Geometric Mean Ratio|0.862|||||TWO_SIDED|90.0|0.753|0.988||||||Cmax of Midazolam: Cycle 1 Day 1, Lenvatinib (single-dose) + Midazolam vs. Cycle 1 Day -3, Midazolam||0.988|0.753|
71084121|NCT02686164|141673892|OTHER||Geometric Mean Ratio|1.027|||||TWO_SIDED|90.0|0.852|1.238||||||Cmax of Midazolam: Cycle 1 Day 14, Lenvatinib (steady state) + Midazolam vs. Cycle 1 Day -3, Midazolam||1.238|0.852|
71084122|NCT02686164|141673892|OTHER||Geometric Mean Ratio|1.055|||||TWO_SIDED|90.0|0.879|1.268||||||Cmax of 1'-hydroxy midazolam: Cycle 1 Day 1, Lenvatinib (single-dose) + Midazolam vs. Cycle 1 Day -3, Midazolam||1.268|0.879|
71084123|NCT02686164|141673892|OTHER||Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.845|1.046||||||Cmax of 1'-hydroxy midazolam: Cycle 1 Day 14, Lenvatinib (steady state) + Midazolam vs. Cycle 1 Day -3, Midazolam||1.046|0.845|
71084124|NCT02465164|141673914|OTHER|Wilcoxon rank-sum tests||||||0.208|||||||Wilcoxon (Mann-Whitney)|||||||0.208
71084125|NCT02499120|141673915|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.18|TWO_SIDED|95.0|0.536|1.253||1-sided p-value was from the log-rank test stratified by stratification factors ECOG(Eastern Cooperative Oncology Group) per randomization.|Log Rank|||||1.253|0.536|0.1800
71084126|NCT02499120|141673916|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.4953|TWO_SIDED|95.0|0.669|1.495||1-sided p-value was from the log-rank test stratified by stratification factors ECOG per randomization.|Log Rank|||||1.495|0.669|0.4953
71084127|NCT00870467|141673982|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71084128|NCT00870467|141673983|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71084129|NCT00870467|141673984|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71084130|NCT00870467|141673985|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71084131|NCT00870467|141673986|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71084132|NCT00870467|141673987|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71084133|NCT02106351|141673996|SUPERIORITY||LS mean difference back transformed|-0.4||||0.0118|TWO_SIDED|||||The 2-tailed significance level was 0.05.|ANCOVA|ANCOVA is performed on the ranked values.||The treatment difference between Dysport 8 U/kg and Dysport 2 U/kg was analysed using an analysis of covariance (ANCOVA) on the ranked changes from baseline. The model included treatment group, the baseline value, the 2 stratification factors (age range and BTX status at baseline) and the pooled centre as fixed effects. The derived least squares (LS) means were back transformed to the original scale and the treatment difference determined.||||0.0118
71084134|NCT02106351|141673996|SUPERIORITY||LS mean difference back transformed|-0.7|||<|0.0001|TWO_SIDED|||||The 2-tailed significance level was 0.05.|ANCOVA|ANCOVA is performed on the ranked values.||The treatment difference between Dysport 16 U/kg and Dysport 2 U/kg was analysed using an ANCOVA on the ranked changes from baseline. The model included treatment group, the baseline value, the 2 stratification factors (age range and BTX status at baseline) and the pooled centre as fixed effects. The derived LS means were back transformed to the original scale and the treatment difference determined.||||<0.0001
71084135|NCT02106351|141673997|SUPERIORITY||LS mean difference back transformed|0.2||||0.2043|TWO_SIDED|||||The two-tailed significance level was 0.05.|ANOVA|ANOVA was performed on ranked values.||The treatment difference between Dysport 8 U/kg and Dysport 2 U/kg was analysed using an analysis of variance (ANOVA) on the rank of the PGA score at TC 1, Week 6. The model included treatment group, the 2 stratification factors (age range and BTX status at baseline) and the centre as fixed effects. The derived LS means were back transformed to the original scale and the treatment difference determined.||||0.2043
71084136|NCT02106351|141673997|SUPERIORITY||LS mean difference back transformed|0.2||||0.188|TWO_SIDED|||||The two-tailed significance level was 0.05.|ANOVA|ANOVA was performed on ranked values.||The treatment difference between Dysport 16 U/kg and Dysport 2 U/kg was analysed using an ANOVA on the rank of the PGA score at TC 1, Week 6. The model included treatment group, the 2 stratification factors (age range and BTX status at baseline) and the centre as fixed effects. The derived LS means were back transformed to the original scale and the treatment difference determined.||||0.1880
71084137|NCT02106351|141673998|SUPERIORITY||LS mean difference|0.5||||0.7648|TWO_SIDED|95.0|-2.7|3.7||The two-tailed significance level was 0.05.|ANOVA|||The treatment difference between Dysport 8 U/kg and Dysport 2 U/kg was analysed using ANOVA on the GAS Total score at TC 1, Week 6. The model included treatment group, the 2 stratification factors (age range and BTX status at baseline) and the centre as fixed effects.||3.7|-2.7|0.7648
71084138|NCT02106351|141673998|SUPERIORITY||LS mean difference|0.5||||0.7429|TWO_SIDED|95.0|-2.6|3.7||The two-tailed significance level was 0.05.|ANOVA|||The treatment difference between Dysport 16 U/kg and Dysport 2 U/kg was analysed using ANOVA on the GAS Total score at TC 1, Week 6. The model included treatment group, the 2 stratification factors (age range and BTX status at baseline) and the centre as fixed effects.||3.7|-2.6|0.7429
71084139|NCT00520039|141674010|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.09|STANDARD_ERROR_OF_MEAN|0.94||0.02|TWO_SIDED|95.0|0.15|2.03|||Chi-squared|df = 1|The denominator of the Odds ratio represents the odds of improvement for the Standard Care Only (SCO) group.|Test of the null hypothesis that there is no improvement in MEE at Visit 3 using tympanogram.||2.03|0.15|0.02
71084140|NCT00520039|141674011|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.31|STANDARD_ERROR_OF_MEAN|1.31||0.32|TWO_SIDED|95.0|-1.0|1.62|||Chi-squared|df = 1|The odds of Resolution of MEE before OMT is represented in the denominator of the odds ratio|||1.62|-1.00|0.32
71084141|NCT00520039|141674012|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.25|STANDARD_ERROR_OF_MEAN|1.03||0.31|TWO_SIDED|95.0|-0.78|1.28|||Chi-squared|df = 1||||1.28|-0.78|.31
71084142|NCT03284853|141674041|OTHER|The primary analysis was performed on the ITT population with imputation by Markov Chain Monte Carlo method.|||||<|0.05||||||Linear model with IOP at the given visit and time point as the response, baseline IOP as a covariate, and treatment as a main effect factor at each time point (08:00, 10:00, and 16:00 hours at the Week 2, Week 6, and Month 3 Visits).|Regression, Linear|Non-inferiority for PG324 was concluded if the UL of the 95% CI was ≤ l.5 mmHg at all 9 time points and ≤ l.0 mmHg at the majority of time points||Assuming no difference between PG324 and Ganfort, a two-tailed alpha of 0.05 (2-sided 95% CI) at each of 9 time points, a common SD of 3.5 mmHg, and a correlation between time points of ≤ 0.60, 200 ITT subjects per arm were necessary to have 85% power to show clinical non-inferiority of PG324 to Ganfort in the mean change from baseline IOP.||||<0.05
71084143|NCT00765817|141674051|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71084144|NCT00765817|141674052|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
71084145|NCT00765817|141674053|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
71084146|NCT00765817|141674054|SUPERIORITY_OR_OTHER|||||||0.174||95.0|||||ANCOVA|||||||0.174
71084147|NCT00765817|141674056|SUPERIORITY_OR_OTHER|||||||0.203||95.0|||||ANCOVA|||||||0.203
71084148|NCT00765817|141674057|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||ANCOVA|||||||0.063
71084149|NCT00765817|141674058|SUPERIORITY_OR_OTHER|||||||0.745||95.0|||||ANCOVA|||||||0.745
71084150|NCT00765817|141674059|SUPERIORITY_OR_OTHER|||||||0.933||95.0|||||ANCOVA|||||||0.933
71084151|NCT00765817|141674060|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71084152|NCT00765817|141674061|SUPERIORITY_OR_OTHER|||||||0.226||95.0|||||ANCOVA|||||||0.226
71084153|NCT00765817|141674062|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||ANCOVA|||||||0.026
71084154|NCT00765817|141674063|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||ANCOVA|||||||0.070
71084155|NCT00765817|141674064|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||ANCOVA|||||||0.011
71084156|NCT00765817|141674065|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71084157|NCT00765817|141674066|SUPERIORITY_OR_OTHER|||||||0.666||95.0|||||Negative binomial regression model|||||||0.666
71084158|NCT00765817|141674067|SUPERIORITY_OR_OTHER|||||||0.486||95.0|||||Fisher Exact|||||||0.486
70856283|NCT00545129|141199456|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.49||0.992|TWO_SIDED|95.0|-1.0|1.0|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.00|-1.00|0.992
71084159|NCT01043133|141674068|SUPERIORITY_OR_OTHER||log-binomial|3.97|STANDARD_ERROR_OF_MEAN|3.97||0.01|TWO_SIDED|95.0|1.34|11.79|||log-binomial regression||Robust Huber-White standard errors account for clustering|||11.79|1.34|.01
71084160|NCT01043133|141674069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25|STANDARD_DEVIATION|2.78||0.05|TWO_SIDED|95.0|-2.48|-0.03|||ANCOVA|||||-.03|-2.48|.05
71084161|NCT00255164|141674070|SUPERIORITY_OR_OTHER||||||<|1e-05||||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact|||||||<0.00001
71084162|NCT00255164|141674070|SUPERIORITY_OR_OTHER||||||<|1e-05||||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact|||||||<0.00001
71084163|NCT00255164|141674070|SUPERIORITY_OR_OTHER|||||||0.80473||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.80473
71084164|NCT00255164|141674071|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
71084165|NCT00255164|141674071|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
71084166|NCT00255164|141674071|SUPERIORITY_OR_OTHER|||||||0.76046||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.76046
71084167|NCT00255164|141674073|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank|||||||<0.00001
71084168|NCT00255164|141674073|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank|||||||<0.00001
71084169|NCT00255164|141674073|SUPERIORITY_OR_OTHER|||||||0.37161||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Log Rank|||||||0.37161
71084170|NCT00255164|141674074|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
71084171|NCT00255164|141674074|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
71084172|NCT00255164|141674074|SUPERIORITY_OR_OTHER|||||||0.597||95.0||||Statistical significance was determined at the 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.59700
71084173|NCT01877668|141674119|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.13|STANDARD_ERROR_OF_MEAN|6.67||0.0102|TWO_SIDED|95.0|4.06|30.21|||Large sample approximation|Missing response (MR)=non-response (NR)||||30.21|4.06|0.0102
70856284|NCT00545129|141199456|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.53||0.655|TWO_SIDED|95.0|-1.34|0.86|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.86|-1.34|0.655
71084174|NCT01877668|141674119|SUPERIORITY_OR_OTHER||Risk Difference (RD)|27.24|STANDARD_ERROR_OF_MEAN|6.64|<|0.0001|TWO_SIDED|95.0|14.22|40.26|||Large sample approximation|MR=NR||||40.26|14.22|<0.0001
71084175|NCT01877668|141674119|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.55|STANDARD_ERROR_OF_MEAN|6.69||0.0055|TWO_SIDED|95.0|5.45|31.66|||Large sample approximation|MR=NR||||31.66|5.45|0.0055
71084176|NCT01877668|141674120|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1697|STANDARD_ERROR_OF_MEAN|0.06173||0.0062|TWO_SIDED|95.0|-0.291|-0.0483|||Mixed Models Analysis|No imputation.||||-0.0483|-0.2910|0.0062
71084177|NCT01877668|141674120|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2196|STANDARD_ERROR_OF_MEAN|0.06184||0.0004|TWO_SIDED|95.0|-0.3411|-0.098|||Mixed Models Analysis|No imputation.||||-0.0980|-0.3411|0.0004
71084178|NCT01877668|141674120|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2005|STANDARD_ERROR_OF_MEAN|0.06145||0.0012|TWO_SIDED|95.0|-0.3213|-0.0797|||Mixed Models Analysis|No imputation.||||-0.0797|-0.3213|0.0012
71084179|NCT00377637|141674177|SUPERIORITY_OR_OTHER|||||||0.478||95.0|||||Regression, Logistic|Covariates included Treatment, Race, Geographical Region, and WHO Lupus Nephritis Class V and specified interaction terms.||||||0.478
71084180|NCT00377637|141674178|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Testing at the alpha=0.05 level was applied with no adjustments made for multiplicity.|Log Rank|||The difference in Kaplan-Meier survival curves between treatment groups (MMF-AZA) was assessed using a log-rank test, which is a non-parametric test to compare the survival distributions of two groups commonly used to analyze time-to-event endpoints.||||0.003
71084181|NCT01111565|141674192|SUPERIORITY||Treatment Difference|-5.4|||=|0.079|TWO_SIDED|95.0|-11.5|0.7|||ANCOVA|||||0.7|-11.5|=0.079
71084182|NCT01111565|141674192|SUPERIORITY||Treatment Difference|-5.2|||=|0.085|TWO_SIDED|95.0|-11.2|0.7|||ANCOVA|||||0.7|-11.2|=0.085
71084183|NCT01111565|141674193|SUPERIORITY||Treatment Difference|-0.5|||=|0.148|TWO_SIDED|95.0|-1.1|0.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Row Mean Scores Test was used to determine the p-value.||||0.1|-1.1|=0.148
71084184|NCT01111565|141674193|SUPERIORITY||Treatment Difference|-0.4|||=|0.242|TWO_SIDED|95.0|-1.0|0.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Row Mean Scores Test was used to determine the p-value.||||0.3|-1.0|=0.242
71084185|NCT01111565|141674194|SUPERIORITY||Treatment Difference|0.1|||=|0.91|TWO_SIDED|95.0|-1.8|2.1|||ANCOVA|||||2.1|-1.8|=0.910
71084186|NCT01111565|141674194|SUPERIORITY||Treatment Difference|-1.0|||=|0.291|TWO_SIDED|95.0|-3.0|0.9|||ANCOVA|||||0.9|-3.0|=0.291
71084187|NCT00583908|141674199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.5|STANDARD_DEVIATION|17.1|<|0.0001||95.0||||Paired t-test|t-test, 1 sided||mean difference was senofilcon A minus balafilcon A|Alternative Hypothesis was senofilcon A toric was superior to balafilcon A toric by having less degrees of rotation||||<0.0001
71084188|NCT00583908|141674199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.4|STANDARD_DEVIATION|17.8||0.0002||95.0||||paired t-test|t-test, 1 sided||mean difference is senofilcon A minus lotrafilcon B|Hypothesis was senofilcon A toric was superior to lotrafilcon B toric by having less degree of rotation||||0.0002
71084189|NCT00583908|141674199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.0|STANDARD_DEVIATION|12.4|<|0.0001||95.0||||paired t-test|t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|Hypothesis was senofilcon A toric was superior to omafilcon A toric by having less degree of rotation||||<0.0001
71084190|NCT00583908|141674200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|STANDARD_DEVIATION|0.15||0.0083||95.0|||||t-test, 1 sided||Mean difference was senofilcon A minus balafilcon A|Alternative hypothesis was senofilcon A toric was superior to balafilcon A toric by having a lower logMAR score||||0.0083
71084191|NCT00583908|141674200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|0.09||0.052||95.0|||||t-test, 1 sided||Mean difference was senofilcon A minus lotrafilcon B|Alternative hypothesis was senofilcon A toric was superior to lotrafilcon B toric by having a lower logMAR score||||0.052
71084192|NCT00583908|141674200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|STANDARD_DEVIATION|0.14||0.015||95.0|||||t-test, 1 sided||Mean difference was senofilcon A minus omafilcon A|Alternative hypothesis was senofilcon A toric was superior to omafilcon A toric by having a lower logMAR score||||0.015
71084193|NCT00583908|141674201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_DEVIATION|6.5||0.16||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.16
71084194|NCT00583908|141674201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_DEVIATION|3.5||0.73||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.73
71084195|NCT00583908|141674201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_DEVIATION|4.4||0.044||95.0|||||t-test, 1 sided||Mean difference was senofilcon A minus omafilcon A|||||0.044
71084196|NCT00583908|141674202|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.1|STANDARD_DEVIATION|5.0||0.044||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.044
71084197|NCT00583908|141674202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|STANDARD_DEVIATION|4.7||0.31||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.31
70856285|NCT00545129|141199456|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.58||0.86|TWO_SIDED|95.0|-1.09|1.3|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.30|-1.09|0.860
70856286|NCT00545129|141199456|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.59||0.595|TWO_SIDED|95.0|-1.52|0.89|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.89|-1.52|0.595
70856287|NCT00545129|141199457|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.5||0.179|TWO_SIDED|95.0|-1.76|0.35|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.35|-1.76|0.179
70856288|NCT00545129|141199457|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.51||0.938|TWO_SIDED|95.0|-1.02|1.1|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.10|-1.02|0.938
71084198|NCT00583908|141674202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_DEVIATION|5.9||0.44||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|||||0.44
70856289|NCT00545129|141199457|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.55||0.621|TWO_SIDED|95.0|-1.41|0.86|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.86|-1.41|0.621
71084199|NCT00583908|141674203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_DEVIATION|6.5||0.78||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.78
71084200|NCT00583908|141674203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_DEVIATION|6.3||0.68||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.68
71084201|NCT00583908|141674203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|7.6||0.78||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|||||0.78
71084202|NCT00583908|141674204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|STANDARD_DEVIATION|6.5||0.11||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.11
71084203|NCT00583908|141674204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_DEVIATION|4.3||0.31||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.31
71084204|NCT00583908|141674204|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.0|STANDARD_DEVIATION|6.3||0.16||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|||||0.16
71084205|NCT00583908|141674205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|STANDARD_DEVIATION|6.8||0.061||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.061
71084206|NCT00583908|141674205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_DEVIATION|3.9||0.47||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.47
71084207|NCT00583908|141674205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_DEVIATION|3.6||0.38||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|||||0.38
71084208|NCT00583908|141674206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_DEVIATION|3.5||0.17||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.17
71084209|NCT00583908|141674206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|5.0||0.89||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.89
71122507|NCT02011490|141750780|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|5.49|||||TWO_SIDED|90.0|4.18|7.22|||||Difference in least squares means of log-transformed data (severe renal impaired - healthy) was back transformed to geometric least squares mean ratio (severe renal impaired/healthy)|Log-transformed plasma values were modeled using an ANOVA linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect||7.22|4.18|
71084210|NCT00583908|141674206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|STANDARD_DEVIATION|5.8||0.56||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|||||0.56
71084211|NCT00583908|141674207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0|STANDARD_DEVIATION|6.8||0.008||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.0080
71084212|NCT00583908|141674207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_DEVIATION|3.1||0.0049||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.0049
71122508|NCT02011490|141750780|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|2.42|||||TWO_SIDED|90.0|1.84|3.18|||||Difference in least squares means of log-transformed data (moderate renal impaired - healthy) was back transformed to geometric least squares mean ratio (moderate renal impaired/healthy)|Log-transformed plasma values were modeled using an ANOVA linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect||3.18|1.84|
71084213|NCT00583908|141674207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.4|STANDARD_DEVIATION|5.6||0.0058||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|||||0.0058
71084214|NCT00583908|141674208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_DEVIATION|3.7||0.27||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.27
71084215|NCT00583908|141674208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_DEVIATION|6.0||0.85||95.0|||||t-test, 1 sided||Mean difference is senofilocon A minus lotrafilcon B|||||0.85
71084216|NCT00583908|141674208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|2.6||0.73||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omifilcon A|||||0.73
71084217|NCT03257436|141674232|OTHER|"A power calculation using a sample size of 61 subjects as the non-responders with the LV MSP on was calculated based on a one-sided exact test for a single binomial proportion, using SAS Version 9.4 with the following assumptions:~* Performance goal = 90%~* Expected LV MSP feature-related CFR rate between 6 and 12 Month Visit = 98%~* Significance level = 5%~* Power = 80%"|Kaplan Meir Methodology|99.0|||||ONE_SIDED|95.0|94.1|||||||"The LV MSP feature-related CFR between the 6 Month Visit and the 12 Month Visit was calculated using Kaplan-Meier methodology.~H0: LV MSP feature-related complication-free rate between 6 Month Visit and 12 Month Visit ≤ 90%.~The sample size of 61 subjects was required to evaluate the Primary Safety Endpoint using an exact test since a power calculation cannot be directly calculated for a one group Kaplan-Meier analysis."|||94.1|
70856290|NCT00545129|141199457|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.64||0.863|TWO_SIDED|95.0|-1.44|1.21|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.21|-1.44|0.863
71084218|NCT03257436|141674233|OTHER|Even though fewer subjects (78) were available for the effectiveness endpoint analysis than originally planned (110), the study was still powered at approximately 90%|Proportion|51.3|||||ONE_SIDED|95.0|41.1|||||||"The effectiveness endpoint for SMART MSP PAS is the proportion of the LV MSP Group with an Improved CCS. For this endpoint, those subjects in the LV MSP Group that become responders will be defined as having an Improved CCS.~H0: Proportion of LV MSP Group subjects with Improved CCS from 6 Month Visit through 12 Month Visit ≤ 5%"|||41.1|
70856291|NCT00545129|141199457|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.59||0.237|TWO_SIDED|95.0|-1.95|0.51|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.51|-1.95|0.237
70856292|NCT00545129|141199458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.75||||1|TWO_SIDED|95.0|0.1|4.94|||Fisher Exact|||Week 1 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||4.94|0.10|1.000
70856293|NCT00545129|141199458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.88||||1|TWO_SIDED|95.0|0.23|3.32|||Fisher Exact|||Week 2 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||3.32|0.23|1.000
70856294|NCT00545129|141199458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.67||||1|TWO_SIDED|95.0|0.05|6.35|||Fisher Exact|||Week 2 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||6.35|0.05|1.000
71084219|NCT01305811|141674234|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||general estimating equations|||||||0.03
70856295|NCT00545129|141199458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.4||||0.601|TWO_SIDED|95.0|0.44|4.53|||Fisher Exact|||Week 4 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||4.53|0.44|0.601
70856296|NCT00545129|141199458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.36|TWO_SIDED|95.0|0.46|8.51|||Fisher Exact|||Week 4 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||8.51|0.46|0.360
70856297|NCT00545129|141199458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.5||||1|TWO_SIDED|95.0|0.01|10.24|||Fisher Exact|||Week 4 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||10.24|0.01|1.000
70856298|NCT00545129|141199458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.41||||0.596|TWO_SIDED|95.0|0.43|4.66|||Fisher Exact|||Week 6 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||4.66|0.43|0.596
70856299|NCT00545129|141199458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.52||||0.552|TWO_SIDED|95.0|0.39|6.24|||Fisher Exact|||Week 6 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||6.24|0.39|0.552
70856300|NCT00545129|141199458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.15||||0.612|TWO_SIDED|95.0|0.1|131.03|||Fisher Exact|||Week 6 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||131.03|0.10|0.612
70856301|NCT00545129|141199458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|0.0|19.66|||Fisher Exact|||Week 6 (\>=90%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||19.66|0.00|1.000
70856302|NCT00545129|141199458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.73||||0.029|TWO_SIDED|95.0|1.04|14.32|||Fisher Exact|||Week 8 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||14.32|1.04|0.029
71084220|NCT01305811|141674235|SUPERIORITY_OR_OTHER||||||=|0.22|TWO_SIDED||||||t-test, 2 sided|||In our original proposal to the funder, to protect our main outcome from possibly large attrition, we proposed to initially test mean differences between groups following 2 months of treatment or wait list using Student's t-tests at an alpha=0.05.||||=0.22
71084221|NCT03064113|141674236|SUPERIORITY||Difference of LS Mean|173.8|||<|0.001|TWO_SIDED|95.0|112.4|235.3|||t-test, 2 sided|||||235.3|112.4|<0.001
71084222|NCT03064113|141674236|SUPERIORITY||Difference of LS Mean|169.3|||<|0.001|TWO_SIDED|95.0|107.8|230.8|||t-test, 2 sided|||||230.8|107.8|<0.001
71084223|NCT03064113|141674236|SUPERIORITY||Difference of LS Mean|175.6|||<|0.001|TWO_SIDED|95.0|114.1|237.2|||t-test, 2 sided|||||237.2|114.1|<0.001
71084224|NCT03064113|141674237|SUPERIORITY||Slope|112.5||||0.001|TWO_SIDED|95.0|44.5|180.5|||t-test, 2 sided|||Tx Difference of LS Mean FEV1 at 12 hr||180.5|44.5|0.001
71122509|NCT02011490|141750781|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|0.94|||||TWO_SIDED|90.0|0.73|1.21|||||Difference in least squares means of log-transformed data (severe renal impaired - healthy) was back transformed to geometric least squares mean ratio (severe renal impaired/healthy)|Log-transformed plasma values were modeled using an ANOVA linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect||1.21|0.73|
71122510|NCT02011490|141750781|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|0.92|||||TWO_SIDED|90.0|0.72|1.18|||||Difference in least squares means of log-transformed data (moderate renal impaired - healthy) was back transformed to geometric least squares mean ratio (moderate renal impaired/healthy)|Log-transformed plasma values were modeled using an ANOVA linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect||1.18|0.72|
71122511|NCT03697993|141750799|OTHER||Risk Difference (RD)|-18.0||||0.264|TWO_SIDED|95.0|-43.4|8.7|||Multiple imputation using Wald method|||||8.7|-43.4|0.264
71122512|NCT03697993|141750803|OTHER||Risk Difference (RD)|-1.0||||1|TWO_SIDED|95.0|-26.2|24.3|||Fisher Exact|||||24.3|-26.2|1.000
71122513|NCT03697993|141750804|OTHER||Odds Ratio (OR)|0.9||||0.894|TWO_SIDED|95.0|0.3|2.5|||Proportional odds model using Wald test|||||2.5|0.3|0.894
70856303|NCT00545129|141199458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.63||||0.143|TWO_SIDED|95.0|0.67|11.36|||Fisher Exact|||Week 8 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||11.36|0.67|0.143
71084225|NCT03064113|141674237|SUPERIORITY||Difference of LS Mean|123.4|||<|0.001|TWO_SIDED|95.0|54.6|192.3|||t-test, 2 sided|||Tx Difference of LS Mean FEV1 at 12 hr||192.3|54.6|<0.001
71084226|NCT03064113|141674237|SUPERIORITY||Difference of LS Mean|15.3||||0.659|TWO_SIDED|95.0|-53.5|94.1|||t-test, 2 sided|||Tx Difference of LS Mean FEV1 at 12 hr||94.1|-53.5|0.659
71084227|NCT03064113|141674237|SUPERIORITY||Difference of LS Mean|102.8|||<|0.001|TWO_SIDED|95.0|54.1|151.5|||t-test, 2 sided|||Tx Difference of LS Mean FEV1 at 24 hr||151.5|54.1|<0.001
71084228|NCT03064113|141674237|SUPERIORITY||Difference of LS Mean|136.6|||<|0.001|TWO_SIDED|95.0|87.8|185.3|||t-test, 2 sided|||Tx Difference of LS Mean FEV1 at 24 hr||185.3|87.8|<0.001
71084229|NCT03064113|141674237|SUPERIORITY|Tx Difference of LS Mean FEV1 at 24 hr|Difference of LS Mean|-24.2||||0.327|TWO_SIDED|95.0|-72.9|24.6|||t-test, 2 sided|||||24.6|-72.9|0.327
71084230|NCT03064113|141674238|SUPERIORITY||Difference of LS Mean|26.4|||<|0.001|TWO_SIDED|95.0|18.0|34.8|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-12 hrs||34.8|18.0|<0.001
71084231|NCT03064113|141674238|SUPERIORITY||Difference of LS Mean|29.1|||<|0.001|TWO_SIDED|95.0|20.8|37.4|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-12 hrs||37.4|20.8|<0.001
71084232|NCT03064113|141674238|SUPERIORITY||Difference of LS Mean|25.6|||<|0.001|TWO_SIDED|95.0|17.3|33.9|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-12 hrs||33.9|17.3|<0.001
71084233|NCT03064113|141674238|SUPERIORITY||Difference of LS Mean|20.1|||<|0.001|TWO_SIDED|95.0|12.1|28.2|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-24 hrs||28.2|12.1|<0.001
71122514|NCT03697993|141750805|OTHER||Risk Difference (RD)|0.0||||0.973|TWO_SIDED|95.0|-26.3|25.3|||Multiple imputation using Wald method|||||25.3|-26.3|0.973
71122515|NCT04384107|141750808|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-1.1|||=|0.641|TWO_SIDED|95.0|-5.9|3.6|||Miettinen & Nurminen|||Injection site erythema||3.6|-5.9|= 0.641
71122516|NCT04384107|141750808|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-0.2|||=|0.937|TWO_SIDED|95.0|-6.1|5.6|||Miettinen & Nurminen|||Injection site induration||5.6|-6.1|= 0.937
71122517|NCT04384107|141750808|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|7.1|||=|0.036|TWO_SIDED|95.0|0.5|13.8|||Miettinen & Nurminen|||Injection site pain||13.8|0.5|= 0.036
71122518|NCT04384107|141750808|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-4.0|||=|0.208|TWO_SIDED|95.0|-10.2|2.2|||Miettinen & Nurminen|||Injection site swelling||2.2|-10.2|= 0.208
71084234|NCT03064113|141674238|SUPERIORITY||Difference of LS Mean|25.4|||<|0.001|TWO_SIDED|95.0|17.4|33.4|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-24 hrs||33.4|17.4|<0.001
71084235|NCT03064113|141674238|SUPERIORITY||Difference of LS Mean|10.6||||0.01|TWO_SIDED|95.0|2.5|18.6|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-24 hr||18.6|2.5|0.010
71084236|NCT03064113|141674239|SUPERIORITY||Difference of LS Mean|0.1||||0.003|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr||0.2|0.0|0.003
71084237|NCT03064113|141674239|SUPERIORITY||Difference of LS Mean|0.1||||0.046|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr||0.2|0.0|0.046
71084238|NCT03064113|141674239|SUPERIORITY||Difference of LS Mean|0.1||||0.003|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr||0.2|0.0|0.003
71084239|NCT03064113|141674239|SUPERIORITY||Difference of LS Mean|0.1||||0.003|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr||0.2|0.0|0.003
71084240|NCT03064113|141674239|SUPERIORITY||Difference of LS Mean|0.1||||0.048|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr||0.2|0.0|0.048
70856304|NCT00545129|141199458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||1|TWO_SIDED|95.0|0.07|15.25|||Fisher Exact|||Week 8 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||15.25|0.07|1.000
71084241|NCT03064113|141674239|SUPERIORITY||Difference of LS Mean|0.1||||0.007|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr||0.2|0.0|0.007
71084242|NCT03064113|141674240|SUPERIORITY||Difference of LS Mean|0.1||||0.054|TWO_SIDED|95.0|0.0|0.1|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr||0.1|-0.0|0.054
71084243|NCT03064113|141674240|SUPERIORITY||Difference of LS Mean|0.1||||0.045|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr||0.2|0.0|0.045
71084244|NCT03064113|141674240|SUPERIORITY||Difference of LS Mean|0.0||||0.503|TWO_SIDED|95.0|0.0|0.1|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr||0.1|-0.0|0.503
71084245|NCT03064113|141674240|SUPERIORITY||Difference of LS Mean|0.0||||0.183|TWO_SIDED|95.0|0.0|0.1|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr||0.1|-0.0|0.183
71084246|NCT03064113|141674240|SUPERIORITY||Difference of LS Mean|0.0||||0.422|TWO_SIDED|95.0|0.0|0.1|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr||0.1|-0.0|0.422
71084247|NCT03064113|141674240|SUPERIORITY||Difference of LS Mean|0.0||||0.287|TWO_SIDED|95.0|-0.1|0.0|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr||0.0|-0.1|0.287
71122519|NCT04384107|141750809|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-0.4|||=|0.912|TWO_SIDED|95.0|-6.7|6.0|||Miettinen & Nurminen|||Decreased appetite||6.0|-6.7|= 0.912
70856305|NCT00545129|141199458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.492|TWO_SIDED|95.0|0.0|3.57|||Fisher Exact|||Week 8 (\>=90%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||3.57|0.00|0.492
70856306|NCT00545129|141199459|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.75||||1|TWO_SIDED|95.0|0.1|4.94|||Fisher Exact|||Week 1 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||4.94|0.10|1.000
70856307|NCT00545129|141199459|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.88||||1|TWO_SIDED|95.0|0.23|3.32|||Fisher Exact|||Week 2 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||3.32|0.23|1.000
71084248|NCT03064113|141674242|SUPERIORITY||Difference of LS Mean|3975.5|||<|0.001|TWO_SIDED|95.0|2007.3|5943.7|||t-test, 2 sided|||||5943.7|2007.3|<0.001
71084249|NCT03064113|141674242|SUPERIORITY||Difference of LS Mean|5888.9|||<|0.001|TWO_SIDED|95.0|3924.4|7853.4|||t-test, 2 sided|||||7853.4|3924.4|<0.001
71084250|NCT03064113|141674242|SUPERIORITY||Difference of LS Mean|2654.7||||0.009|TWO_SIDED|95.0|689.7|4619.6|||t-test, 2 sided|||||4619.6|689.7|0.009
71084251|NCT03990051|141674265|SUPERIORITY|Comparison of changes in score from baseline, Active - Placebo.||||||0.0197|||||||Mixed Models Analysis|||||||0.0197
71084252|NCT03990051|141674266|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0039|||||||Mixed Models Analysis|||||||0.0039
71084253|NCT03990051|141674267|SUPERIORITY|Comparison of changes in score from baseline.|||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71084254|NCT03990051|141674268|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0002|||||||ANCOVA|||||||0.0002
71084255|NCT03990051|141674269|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0138|||||||Mixed Models Analysis|||||||0.0138
71084256|NCT03990051|141674270|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0014|||||||Mixed Models Analysis|||||||0.0014
71084257|NCT03990051|141674271|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0849|||||||Mixed Models Analysis|||||||0.0849
71084258|NCT03990051|141674272|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0041|||||||Mixed Models Analysis|||||||0.0041
71084259|NCT03990051|141674273|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0006|||||||Mixed Models Analysis|||||||0.0006
71084260|NCT03990051|141674274|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0143|||||||Mixed Models Analysis|||||||0.0143
71084261|NCT03990051|141674275|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0398|||||||Mixed Models Analysis|||||||0.0398
71084262|NCT03990051|141674276|SUPERIORITY|Comparison of changes in score from baseline.||||||-3.97|||||||Mixed Models Analysis|||||||-3.97
71084263|NCT03990051|141674277|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0005|||||||Mixed Models Analysis|||||||0.0005
71084264|NCT03990051|141674278|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0005|||||||Mixed Models Analysis|||||||0.0005
71084265|NCT03990051|141674279|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0067|||||||Mixed Models Analysis|||||||0.0067
71084266|NCT03990051|141674280|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0636|||||||Mixed Models Analysis|||||||0.0636
71084267|NCT03990051|141674281|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0028|||||||Mixed Models Analysis|||||||0.0028
71084268|NCT03990051|141674282|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0067|||||||Mixed Models Analysis|||||||0.0067
71084269|NCT03990051|141674283|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0105|||||||Mixed Models Analysis|||||||0.0105
71122520|NCT04384107|141750809|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|5.9|||=|0.108|TWO_SIDED|95.0|-1.3|13.0|||Miettinen & Nurminen|||Irritability||13.0|-1.3|= 0.108
70856308|NCT00545129|141199459|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.67||||1|TWO_SIDED|95.0|0.05|6.35|||Fisher Exact|||Week 2 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||6.35|0.05|1.000
71084270|NCT03990051|141674284|SUPERIORITY|Comparison of changes in score from baseline.||||||0.001|||||||Mixed Models Analysis|||||||0.0010
71084271|NCT03990051|141674285|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0155|||||||Mixed Models Analysis|||||||0.0155
71084272|NCT03990051|141674286|SUPERIORITY|Comparison of changes in score from baseline.||||||0.016|||||||Mixed Models Analysis|||||||0.0160
71084273|NCT03990051|141674287|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0117|||||||Mixed Models Analysis|||||||0.0117
71084274|NCT03990051|141674288|SUPERIORITY|Comparison of changes in score from baseline.||||||0.4649|||||||Mixed Models Analysis|||||||0.4649
70856309|NCT00545129|141199459|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.22||||0.795|TWO_SIDED|95.0|0.38|3.88|||Fisher Exact|||Week 4 (\>=30%) reduction: odds ratio with 95% 2-sided CI for the treatment contrast was given.||3.88|0.38|0.795
70856310|NCT00545129|141199459|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.36|TWO_SIDED|95.0|0.46|8.51|||Fisher Exact|||Week 4 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||8.51|0.46|0.360
70856311|NCT00545129|141199459|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.5||||1|TWO_SIDED|95.0|0.01|10.24|||Fisher Exact|||Week 4 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||10.24|0.01|1.000
70856312|NCT00545129|141199459|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.06||||1|TWO_SIDED|95.0|0.33|3.39|||Fisher Exact|||Week 6 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||3.39|0.33|1.000
71084275|NCT03990051|141674289|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0082|||||||Mixed Models Analysis|||||||0.0082
71084276|NCT03990051|141674290|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0225|||||||Mixed Models Analysis|||||||0.0225
71084277|NCT03990051|141674291|SUPERIORITY|Comparison of changes in score from baseline.||||||0.1822|||||||Mixed Models Analysis|||||||0.1822
71084278|NCT03990051|141674292|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0515|||||||Mixed Models Analysis|||||||0.0515
71084279|NCT03990051|141674293|SUPERIORITY|Comparison of changes in score from baseline.||||||0.044|||||||Mixed Models Analysis|||||||0.044
71084280|NCT03990051|141674294|SUPERIORITY|Comparison of changes of score from baseline.||||||0.083|||||||Mixed Models Analysis|||||||0.083
71084281|NCT03990051|141674295|SUPERIORITY|Comparison of changes in score from baseline.||||||0.7147|||||||Mixed Models Analysis|||||||0.7147
71084282|NCT03990051|141674296|SUPERIORITY|Comparison of changes in score from baseline.||||||0.8251|||||||Mixed Models Analysis|||||||0.8251
71084283|NCT03990051|141674297|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0435|||||||Mixed Models Analysis|||||||0.0435
71084284|NCT03990051|141674298|SUPERIORITY|Comparison of changes in score from baseline.||||||0.013|||||||Mixed Models Analysis|||||||0.0130
71084285|NCT03990051|141674299|SUPERIORITY|Comparison of changes in score from baseline.||||||0.3205|||||||Mixed Models Analysis|||||||0.3205
70856313|NCT00545129|141199459|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.771|TWO_SIDED|95.0|0.33|4.83|||Fisher Exact|||Week 6 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||4.83|0.33|0.771
71084286|NCT03990051|141674300|SUPERIORITY|Comparison of changes in score from baseline.||||||0.1401|||||||Mixed Models Analysis|||||||0.1401
70856314|NCT00545129|141199459|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.15||||0.612|TWO_SIDED|95.0|0.1|131.03|||Fisher Exact|||Week 6 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||131.03|0.10|0.612
70856315|NCT00545129|141199459|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|0.0|19.66|||Fisher Exact|||Week 6 (\>=90%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||19.66|0.00|1.000
70856316|NCT00545129|141199459|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.18||||0.187|TWO_SIDED|95.0|0.66|7.3|||Fisher Exact|||Week 8 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||7.30|0.66|0.187
70856317|NCT00545129|141199459|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.73||||0.399|TWO_SIDED|95.0|0.48|6.43|||Fisher Exact|||Week 8 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||6.43|0.48|0.399
70856318|NCT00545129|141199459|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||1|TWO_SIDED|95.0|0.07|15.25|||Fisher Exact|||Week 8 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||15.25|0.07|1.000
70944574|NCT01723514|141389420|SUPERIORITY||LS Geometric Mean Ratio|-71.16|||<|0.001|TWO_SIDED|95.0|-82.67|-52.0|||Repeated Measures ANCOVA|||Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-52.00|-82.67|< 0.001
71084287|NCT03990051|141674301|SUPERIORITY|Comparison in changes in score from baseline.||||||0.0098|||||||ANCOVA|||||||0.0098
71084288|NCT03990051|141674302|SUPERIORITY|Comparison of changes in score from baseline.||||||0.1032|||||||Mixed Models Analysis|||||||0.1032
71084289|NCT03990051|141674303|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0389|||||||Mixed Models Analysis|||||||0.0389
71084290|NCT03990051|141674304|OTHER||||||<|1e-05|||||||t-test, 2 sided|||Score in 1 year compared to baseline||||<0.00001
71084291|NCT03990051|141674305|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
71084292|NCT03990051|141674306|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
70856319|NCT00545129|141199459|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.492|TWO_SIDED|95.0|0.0|3.57|||Fisher Exact|||Week 8 (\>=90%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||3.57|0.00|0.492
70856320|NCT00545129|141199461|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.68||0.188|TWO_SIDED|95.0|0.77|3.73|||Negative binomial regression|||Week 1: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||3.73|0.77|0.188
70856321|NCT00545129|141199461|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.81|STANDARD_ERROR_OF_MEAN|0.85||0.207|TWO_SIDED|95.0|0.72|4.54|||Negative binomial regression|||Week 2: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||4.54|0.72|0.207
70856322|NCT00545129|141199461|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.71|STANDARD_ERROR_OF_MEAN|0.92||0.317|TWO_SIDED|95.0|0.6|4.93|||Negative binomial regression|||Week 3: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||4.93|0.60|0.317
70856323|NCT00545129|141199461|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.36|STANDARD_ERROR_OF_MEAN|0.7||0.554|TWO_SIDED|95.0|0.5|3.71|||Negative binomial regression|||Week 4: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||3.71|0.50|0.554
71084293|NCT03990051|141674307|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
71084294|NCT03990051|141674308|OTHER|||||||0.0002|||||||t-test, 2 sided|||||||0.0002
71084295|NCT03990051|141674309|OTHER|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
71084296|NCT03990051|141674310|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
71084297|NCT03990051|141674311|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
71084298|NCT03990051|141674312|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
71084299|NCT03990051|141674313|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
71084300|NCT03990051|141674314|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
71084301|NCT03990051|141674315|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
71084302|NCT03990051|141674316|OTHER|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
71084303|NCT03990051|141674317|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
71084304|NCT03990051|141674318|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
71084305|NCT03990051|141674319|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
71084306|NCT03990051|141674320|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
71084307|NCT03990051|141674321|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
71084308|NCT01411852|141674323|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.39|||||TWO_SIDED|95.0|0.12|1.25|||||Adjusted for age (linear spline with knot at 45 years), penetrating vs. blunt or no trauma (1 patient had neither blunt nor penetrating trauma), and Injury Severity Score (ISS). ISS multiply imputed for one patient.|||1.25|0.12|
71084309|NCT01411852|141674324|SUPERIORITY_OR_OTHER||percent difference|-16.0|||||TWO_SIDED|95.0|-26.5|-5.5||||||||-5.5|-26.5|
71084310|NCT01411852|141674325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18|||||TWO_SIDED|95.0|-2.76|0.4||||||||0.40|-2.76|
71084311|NCT01411852|141674326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|||||TWO_SIDED|95.0|-1.61|0.08||||||||0.08|-1.61|
71084312|NCT01411852|141674327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-1.8|2.2||||||||2.2|-1.8|
70856324|NCT00545129|141199461|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|0.35||0.581|TWO_SIDED|95.0|0.32|1.89|||Negative binomial regression|||Week 5: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||1.89|0.32|0.581
71084313|NCT01411852|141674328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.3|1.0||||||||1.0|-0.3|
70856325|NCT00545129|141199461|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.61|STANDARD_ERROR_OF_MEAN|0.27||0.252|TWO_SIDED|95.0|0.26|1.43|||Negative binomial regression|||Week 6: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||1.43|0.26|0.252
70856326|NCT00545129|141199461|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.65|STANDARD_ERROR_OF_MEAN|0.31||0.365|TWO_SIDED|95.0|0.26|1.64|||Negative binomial regression|||Week 7: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||1.64|0.26|0.365
70856327|NCT00545129|141199461|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.25||0.212|TWO_SIDED|95.0|0.25|1.36|||Negative binomial regression|||Week 8: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||1.36|0.25|0.212
70856328|NCT00545129|141199462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.17||0.215|TWO_SIDED|95.0|-0.13|0.55|||ANCOVA|||Change at Week 2 (Fatigue MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.55|-0.13|0.215
70856329|NCT00545129|141199462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.21||0.947|TWO_SIDED|95.0|-0.45|0.42|||ANCOVA|||Change at Week 4 (Fatigue MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.42|-0.45|0.947
70856330|NCT00545129|141199462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.18||0.341|TWO_SIDED|95.0|-0.56|0.2|||ANCOVA|||Change at Week 6 (Fatigue MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.20|-0.56|0.341
70944575|NCT01723514|141389420|SUPERIORITY||LS Geometric Mean Ratio|-79.52|||<|0.001|TWO_SIDED|95.0|-88.29|-64.17|||Repeated Measures ANCOVA|||Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-64.17|-88.29|< 0.001
70944576|NCT01723514|141389420|SUPERIORITY||LS Geometric Mean Ratio|-72.34|||<|0.001|TWO_SIDED|95.0|-83.32|-54.13|||Repeated Measures ANCOVA|||Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-54.13|-83.32|< 0.001
70856331|NCT00545129|141199462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.24||0.18|TWO_SIDED|95.0|-0.83|0.17|||ANCOVA|||Change at Week 2 (Drowsiness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.17|-0.83|0.180
70856332|NCT00545129|141199462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.509|TWO_SIDED|95.0|-0.43|0.84|||ANCOVA|||Change at Week 4 (Drowsiness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.84|-0.43|0.509
70944577|NCT01723514|141389420|SUPERIORITY||LS Geometric Mean Ratio|-73.03|||<|0.001|TWO_SIDED|95.0|-83.79|-55.11|||Repeated Measures ANCOVA|||Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-55.11|-83.79|< 0.001
71084314|NCT01411852|141674329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.4|||||TWO_SIDED|95.0|-42.5|1.6||||||||1.6|-42.5|
71084315|NCT01411852|141674330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.06|0.1||||||||0.10|-0.06|
71084316|NCT01411852|141674331|SUPERIORITY_OR_OTHER||percent difference|-10.2|||||TWO_SIDED|95.0|-22.4|2.0||||||||2.0|-22.4|
71084317|NCT01411852|141674332|SUPERIORITY_OR_OTHER||percent difference|-18.9|||||TWO_SIDED|95.0|-39.2|1.4||||||||1.4|-39.2|
71084318|NCT01411852|141674333|SUPERIORITY_OR_OTHER||percent difference|-10.4|||||TWO_SIDED|95.0|-29.6|8.8||||||||8.8|-29.6|
71084319|NCT01411852|141674334|SUPERIORITY_OR_OTHER||percent difference|-4.4|||||TWO_SIDED|95.0|-16.6|7.8||||||||7.8|-16.6|
70856333|NCT00545129|141199462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.34||0.767|TWO_SIDED|95.0|-0.62|0.82|||ANCOVA|||Change at Week 6 (Drowsiness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.82|-0.62|0.767
70856334|NCT00545129|141199462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.42|STANDARD_ERROR_OF_MEAN|0.25||0.108|TWO_SIDED|95.0|-0.11|0.95|||ANCOVA|||Change at Week 2 (Inability to Concentrate MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.95|-0.11|0.108
71084320|NCT01411852|141674335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-3.8|2.1||||||||2.1|-3.8|
71084321|NCT01411852|141674336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-3.6|2.4||||||||2.4|-3.6|
71084322|NCT01411852|141674337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-2.9|3.1||||||||3.1|-2.9|
71084323|NCT01411852|141674338|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.17|||||TWO_SIDED|95.0|0.03|0.92|||||Adjusted for age (linear spline with knot at 45 years) and Injury Severity Score (ISS). ISS multiply imputed for one patient.|||0.92|0.03|
71084324|NCT01411852|141674339|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92|||||TWO_SIDED|95.0|0.19|19.11|||||Adjusted for age (linear spline with knot at 45 years) and Injury Severity Score (ISS).|||19.11|0.19|
71084325|NCT01411852|141674340|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62|||||TWO_SIDED|95.0|0.22|1.77|||||Adjusted for age (linear spline with knot at 45 years), penetrating mechanism (yes/no), and ISS (linear).|||1.77|0.22|
71122521|NCT04384107|141750809|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|1.0|||=|0.792|TWO_SIDED|95.0|-6.4|8.4|||Miettinen & Nurminen|||Somnolence||8.4|-6.4|= 0.792
71122522|NCT04384107|141750809|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-0.3|||=|0.843|TWO_SIDED|95.0|-3.5|2.8|||Miettinen & Nurminen|||Urticaria||2.8|-3.5|= 0.843
71122523|NCT04384107|141750810|OTHER|Estimated differences and CIs are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.4|1.3||||||||1.3|-1.4|
71122524|NCT04384107|141750811|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-0.3|||<|0.001|TWO_SIDED|95.0|-1.7|0.8|||Miettinen and Nurminen|||Serotype 1: Participants With IgG ≥0.35 μg/mL||0.8|-1.7|< 0.001
71122525|NCT04384107|141750811|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|2.3|||<|0.001|TWO_SIDED|95.0|1.0|4.5|||Miettinen and Nurminen|||Serotype 3: Participants With IgG ≥0.35 μg/mL||4.5|1.0|< 0.001
70856335|NCT00545129|141199462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.37||0.28|TWO_SIDED|95.0|-1.26|0.41|||ANCOVA|||Change at Week 4 (Inability to Concentrate MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.41|-1.26|0.280
70856336|NCT00545129|141199462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.57||0.747|TWO_SIDED|95.0|-1.53|1.15|||ANCOVA|||Change at Week 6 (Inability to Concentrate MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||1.15|-1.53|0.747
71122526|NCT04384107|141750811|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|0.0|||<|0.001|TWO_SIDED|95.0|-1.1|1.1|||Miettinen and Nurminen|||Serotype 4: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|< 0.001
71122527|NCT04384107|141750811|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-1.2|||<|0.001|TWO_SIDED|95.0|-3.0|-0.1|||Miettinen and Nurminen|||Serotype 5: Participants With IgG ≥0.35 μg/mL||-0.1|-3.0|< 0.001
71122528|NCT04384107|141750811|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-0.9|||<|0.001|TWO_SIDED|95.0|-2.6|0.2|||Miettinen and Nurminen|||Serotype 6A: Participants With IgG ≥0.35 μg/mL||0.2|-2.6|< 0.001
71122529|NCT04384107|141750811|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-3.9|||<|0.001|TWO_SIDED|95.0|-6.9|-1.3|||Miettinen and Nurminen|||Serotype 6B: Participants With IgG ≥0.35 μg/mL||-1.3|-6.9|< 0.001
71122530|NCT04384107|141750811|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-0.3|||<|0.001|TWO_SIDED|95.0|-1.7|0.8|||Miettinen and Nurminen|||Serotype 7F: Participants With IgG ≥0.35 μg/mL||0.8|-1.7|< 0.001
71122531|NCT04384107|141750811|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-0.3|||<|0.001|TWO_SIDED|95.0|-1.7|0.8|||Miettinen and Nurminen|||Serotype 9V: Participants With IgG ≥0.35 μg/mL||0.8|-1.7|< 0.001
71122532|NCT04384107|141750811|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-0.3|||<|0.001|TWO_SIDED|95.0|-1.9|1.1|||Miettinen and Nurminen|||Serotype 14: Participants With IgG ≥0.35 μg/mL||1.1|-1.9|< 0.001
71122533|NCT04384107|141750811|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-1.2|||<|0.001|TWO_SIDED|95.0|-3.0|-0.1|||Miettinen and Nurminen|||Serotype 18C: Participants With IgG ≥0.35 μg/mL||-0.1|-3.0|< 0.001
71122534|NCT04384107|141750811|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-0.3|||<|0.001|TWO_SIDED|95.0|-1.7|0.8|||Miettinen and Nurminen|||Serotype 19A: Participants With IgG ≥0.35 μg/mL||0.8|-1.7|< 0.001
70856337|NCT00545129|141199462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.39||0.991|TWO_SIDED|95.0|-0.87|0.88|||ANCOVA|||Change at Week 2 (Nausea MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.88|-0.87|0.991
70856338|NCT00545129|141199462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.27||0.335|TWO_SIDED|95.0|-0.41|0.99|||ANCOVA|||Change at Week 4 (Nausea MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.99|-0.41|0.335
71122535|NCT04384107|141750811|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|0.0|||<|0.001|TWO_SIDED|95.0|-1.1|1.1|||Miettinen and Nurminen|||Serotype 19F: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|< 0.001
71084326|NCT03126786|141674349|SUPERIORITY|The sample size was determined such that the difference in visual acuity between the ACTIVE treatment group and CONTROL treatment group could be estimated within +/- five ETDRS letters. Week 24 data from the Eylea prescribing information was used to estimate a pooled standard deviation of 9.17 letters. With 28 subjects per arm, a two-sided 90% confidence interval with a distance from the mean difference to the limits (half of interval width) will be less than 5 letters.|Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|2.28||0.288|TWO_SIDED|90.0|-6.2|1.4||There was a single primary outcome tested at a single primary endpoint, therefore no adjustments for multiple comparisons were performed. The primary endpoint was assess with a 2-sided alpha level of 0.100.|Mixed model for repeat measures|The covariance structure was assumed to be unstructured.|Estimated Value calculated as Active minus Control.|The primary efficacy analysis comparing ACTIVE with CONTROL on the mean change from baseline (Visit 2, Day 0) BCVA at Week 12 was be performed using a Mixed Model for Repeated Measurements (MMRM). This model included treatment (ACTIVE or CONTROL), visit (Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20) and Visit 8 (Week 24), and the 2-way interactions of treatment and visit, and the BCVA baseline included as the covariate.||1.4|-6.2|0.288
71084327|NCT00379899|141674362|SUPERIORITY_OR_OTHER|||||||0.073|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor (≥ 30 to 399, ≥ 400 to 999, and ≥ 1000)||||||0.073
71084328|NCT00379899|141674363|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62||||0.094||95.0|0.36|1.08|||Cochran-Mantel-Haenszel||Logit estimates (Cinacalcet:Control)|||1.08|0.36|0.094
71084329|NCT00379899|141674364|SUPERIORITY_OR_OTHER|||||||0.018|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||0.018
71084330|NCT00379899|141674366|SUPERIORITY_OR_OTHER|||||||0.258|||||||Cochran-Mantel-Haenszel|||||||0.258
71084331|NCT00379899|141674367|SUPERIORITY_OR_OTHER|||||||0.011|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||0.011
71084332|NCT00379899|141674368|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||<0.001
71084333|NCT00379899|141674369|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||<0.001
71084334|NCT00379899|141674370|SUPERIORITY_OR_OTHER|||||||0.025|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||0.025
71084335|NCT00379899|141674371|SUPERIORITY_OR_OTHER|||||||0.021|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||0.021
71084336|NCT00379899|141674372|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||<0.001
71084337|NCT00379899|141674373|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||<0.001
71084338|NCT03138577|141674387|OTHER||||||||||||||||||Counts and percentages of cases with paralysis were calculated separately for each volume of local anesthetic.|||
71084339|NCT03138577|141674388|OTHER|||||||||||||||Counts and percentages of cases with paralysis were calculated separately for each volume of local anesthetic.|||Counts and percentages of cases with paralysis were calculated separately for each volume of local anesthetic.|||
71084340|NCT03138577|141674389|OTHER||Median Difference (Final Values)|7.5||||0.01|TWO_SIDED||||||Sign test|||||||0.01
71084341|NCT03138577|141674389|OTHER||Median Difference (Final Values)|0.0||||1|TWO_SIDED||||||Sign test|||||||1.00
71084342|NCT03138577|141674390|OTHER||||||||||||||||||Dose response data was fit with a non-parametric smoothing technique for locally weighted regression (lowess) to produce a dose response curve.|||
71084343|NCT03138577|141674391|OTHER||||||||||||||||||Dose response data was fit with a non-parametric smoothing technique for locally weighted regression (lowess) to produce a dose response curve.|||
71084344|NCT03138577|141674392|OTHER||Median Difference (Final Values)|-1.0||||0.01|TWO_SIDED||||||Sign test|||||||0.01
71084345|NCT03138577|141674392|OTHER||Median Difference (Final Values)|0.0||||1|TWO_SIDED||||||Sign test|||||||1.00
71084346|NCT03138577|141674393|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
71084347|NCT00672633|141674411|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.0||||0.52||95.0|||||ANOVA|Repeated measures||The study was designed with 80% power to detect a net improvement of Triglyceride elevles with a sample size of 60.||||0.52
71084348|NCT00672633|141674412|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.0||||0.06||95.0|||||ANOVA|Repeated Measures||No power calculations done for this outcomes||||0.06
71084349|NCT00672633|141674413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.3||||0.27||95.0|||||ANOVA|Repeated Measures||No power calculations were conducted for this outcome||||0.27
71084350|NCT01689441|141674420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.25
71084351|NCT01689441|141674421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.51|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.51
71084352|NCT01689441|141674422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.54|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.54
71084353|NCT01481558|141674425|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|0.01||0.55|TWO_SIDED|95.0|||||ANCOVA|||||||0.55
71084354|NCT04235504|141674441|SUPERIORITY||Mean Difference (Final Values)|-1.42|||<|0.0001|TWO_SIDED|95.0|-1.74|-1.1|||linear mixed model|||||-1.10|-1.74|<0.0001
71084355|NCT04235504|141674442|SUPERIORITY||Mean Difference (Final Values)|27.59|||<|0.0001|TWO_SIDED|95.0|21.59|33.6|||linear mixed model|||||33.60|21.59|<0.0001
71084356|NCT04235504|141674443|SUPERIORITY||Mean Difference (Final Values)|-27.86|||<|0.0001|TWO_SIDED|95.0|-34.16|-21.55|||linear mixed model|||||-21.55|-34.16|<0.0001
71084357|NCT04235504|141674444|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.6227|TWO_SIDED|95.0|-0.37|0.61|||linear mixed model|||||0.61|-0.37|0.6227
71084358|NCT04235504|141674445|SUPERIORITY||Mean Difference (Final Values)|-1.08|||||TWO_SIDED|95.0|-2.17|0.0||Due to the small sample size, p value will not be meaningful. Therefore, p value is not presented|linear mixed model|||||0.00|-2.17|
71084359|NCT04235504|141674446|SUPERIORITY||Mean Difference (Final Values)|28.81|||||TWO_SIDED|95.0|12.34|45.28||Due to the small sample size, p value will not be meaningful. Therefore, p value is not presented|linear mixed model|||||45.28|12.34|
71084360|NCT04235504|141674447|SUPERIORITY||Mean Difference (Final Values)|-28.45|||||TWO_SIDED|95.0|-45.27|-11.64||Due to the small sample size, p value will not be meaningful. Therefore, p value is not presented|linear mixed model|||||-11.64|-45.27|
71122536|NCT04384107|141750811|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-1.8|||<|0.001|TWO_SIDED|95.0|-4.0|-0.2|||Miettinen and Nurminen|||Serotype 23F: Participants With IgG ≥0.35 μg/mL||-0.2|-4.0|< 0.001
71122537|NCT04384107|141750811|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|2.0|||<|0.001|TWO_SIDED|95.0|0.4|4.3|||Miettinen and Nurminen|||Serotype 22F: Participants With IgG ≥0.35 μg/mL||4.3|0.4|<0.001
71122538|NCT04384107|141750811|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-6.8|||=|0.048|TWO_SIDED|95.0|-10.6|-3.5|||Miettinen and Nurminen|||Serotype 33F: Participants With IgG ≥0.35 μg/mL||-3.5|-10.6|= 0.048
71122539|NCT04384107|141750812|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.61|||<|0.001|TWO_SIDED|95.0|0.55|0.67|||Linear model|||Serotype 1: IgG GMC Ratio||0.67|0.55|< 0.001
71122540|NCT04384107|141750812|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.85|||<|0.001|TWO_SIDED|95.0|1.67|2.05|||Linear model|||Serotype 3: IgG GMC Ratio||2.05|1.67|< 0.001
71122541|NCT04384107|141750812|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.84|||<|0.001|TWO_SIDED|95.0|0.76|0.93|||Linear model|||Serotype 4: IgG GMC Ratio||0.93|0.76|< 0.001
71122542|NCT04384107|141750812|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.77|||<|0.001|TWO_SIDED|95.0|0.69|0.87|||Linear model|||Serotype 5: IgG GMC Ratio||0.87|0.69|< 0.001
71122543|NCT04384107|141750812|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.56|||=|0.019|TWO_SIDED|95.0|0.5|0.63|||Linear model|||Serotype 6A: IgG GMC Ratio||0.63|0.50|= 0.019
71122544|NCT04384107|141750812|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.59|||=|0.015|TWO_SIDED|95.0|0.51|0.68|||Linear model|||Serotype 6B: IgG GMC Ratio||0.68|0.51|= 0.015
71122545|NCT04384107|141750812|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.84|||<|0.001|TWO_SIDED|95.0|0.75|0.94|||Linear model|||Serotype 7F: IgG GMC Ratio||0.94|0.75|< 0.001
70856339|NCT00545129|141199462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.55|STANDARD_ERROR_OF_MEAN|0.7||0.159|TWO_SIDED|95.0|-4.57|1.48|||ANCOVA|||Change at Week 6 (Nausea MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||1.48|-4.57|0.159
71122546|NCT04384107|141750812|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.87|||<|0.001|TWO_SIDED|95.0|0.78|0.97|||Linear model|||Serotype 9V: IgG GMC Ratio||0.97|0.78|< 0.001
71122547|NCT04384107|141750812|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.75|||<|0.001|TWO_SIDED|95.0|0.66|0.85|||Linear model|||Serotype 14: IgG GMC Ratio||0.85|0.66|< 0.001
71122548|NCT04384107|141750812|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.67|0.82|||Linear model|||Serotype 18C: IgG GMC Ratio||0.82|0.67|< 0.001
71122549|NCT04384107|141750812|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.65|||<|0.001|TWO_SIDED|95.0|0.59|0.72|||Linear model|||Serotype 19A: IgG GMC Ratio||0.72|0.59|< 0.001
71122550|NCT04384107|141750812|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.75|||<|0.001|TWO_SIDED|95.0|0.69|0.82|||Linear model|||Serotype 19F: IgG GMC Ratio||0.82|0.69|< 0.001
70856340|NCT00545129|141199462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.23||0.136|TWO_SIDED|95.0|-0.16|0.94|||ANCOVA|||Change at Week 2 (Dizziness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.94|-0.16|0.136
70856341|NCT00545129|141199462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.22|STANDARD_ERROR_OF_MEAN|0.37||0.186|TWO_SIDED|95.0|-3.46|5.9|||ANCOVA|||Change at Week 6 (Dizziness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||5.90|-3.46|0.186
71084361|NCT04235504|141674448|SUPERIORITY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-1.32|0.59||Due to the small sample size, p value will not be meaningful. Therefore, p value is not presented|linear mixed model|||||0.59|-1.32|
71084362|NCT00069823|141674469|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|1.2||||0.35|TWO_SIDED|95.0|0.8|2.0||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Rates were compared with incidence-rate ratios (IRR). The IRR and P values were estimated with the use of negative binomial regression models with robust variance estimates.||2.0|0.8|0.35
71122551|NCT04384107|141750813|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|107.45|||||TWO_SIDED|95.0|96.18|120.03||||||Serotype 22F: IgG GMC Ratio||120.03|96.18|
71122552|NCT04384107|141750813|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|32.48|||||TWO_SIDED|95.0|27.72|38.05||||||Serotype 33F: IgG GMC Ratio||38.05|27.72|
71122553|NCT04384107|141750814|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|-0.3|||||TWO_SIDED|95.0|-1.7|0.8||||||Serotype 1: Participants With IgG ≥0.35 μg/mL||0.8|-1.7|
71122554|NCT04384107|141750814|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|3.3|||||TWO_SIDED|95.0|1.8|5.8||||||Serotype 3: Participants With IgG ≥0.35 μg/mL||5.8|1.8|
71122555|NCT04384107|141750814|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|-0.3|||||TWO_SIDED|95.0|-1.7|0.8||||||Serotype 4: Participants With IgG ≥0.35 μg/mL||0.8|-1.7|
71122556|NCT04384107|141750814|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 5: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
71122557|NCT04384107|141750814|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 6A: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
70856342|NCT00545129|141199462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.48||0.292|TWO_SIDED|95.0|-1.52|0.49|||ANCOVA|||Change at Week 2 (Constipation MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.49|-1.52|0.292
70856343|NCT00545129|141199462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.38||0.225|TWO_SIDED|95.0|-0.34|1.3|||ANCOVA|||Change at Week 4 (Constipation MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||1.30|-0.34|0.225
70856344|NCT00545129|141199462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.36||0.517|TWO_SIDED|95.0|-0.58|1.07|||ANCOVA|||Change at Week 6 (Constipation MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||1.07|-0.58|0.517
71084363|NCT00069823|141674470|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|0.9||||0.79|TWO_SIDED|95.0|0.6|1.5||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Rates were compared with incidence-rate ratios (IRR). The IRR and P values were estimated with the use of negative binomial regression models with robust variance estimates.||1.5|0.6|0.79
71084364|NCT00069823|141674471|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|1.1||||0.66|TWO_SIDED|95.0|0.8|1.5||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||The rates of EPACs were compared using incidence-rate ratios (IRR). IRR and P value were estimated with the use of negative binomial regression models with robust variance estimates.||1.5|0.8|0.66
71084365|NCT00069823|141674472|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|0.9||||0.62|TWO_SIDED|95.0|0.6|1.3||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Rates were compared with incidence-rate ratios (IRR). The IRR and P values were estimated with the use of negative binomial regression models with robust variance estimates.||1.3|0.6|0.62
71084366|NCT00069823|141674473|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|1.0||||0.87|TWO_SIDED|95.0|0.8|1.3||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Rates were compared with incidence-rate ratios (IRR). The IRR and P values were estimated with the use of negative binomial regression models with robust variance estimates.||1.3|0.8|0.87
71084367|NCT00069823|141674474|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|0.9||||0.62||95.0|0.7|1.3||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Incidence-rate ratios and P values were estimated with the use of negative binomial regression models with robust variance estimates.||1.3|0.7|0.62
71084368|NCT00069823|141674475|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|0.9||||0.7|TWO_SIDED|95.0|0.6|1.4||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Incidence-rate ratios and P values were estimated with the use of negative binomial regression models with robust variance estimates.||1.4|0.6|0.70
71084369|NCT00069823|141674476|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.36|TWO_SIDED|95.0|-0.03|0.08||P values were calculated with the use of linear regression.|Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group, e.g. 0.00 - (-0.02) = -0.03 (rounding)|The treatment effect is the mean change in the Esomeprazole group - mean change in placebo group||0.08|-0.03|0.36
71084370|NCT00069823|141674477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3|TWO_SIDED|95.0|-0.03|0.09|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||0.09|-0.03|0.30
71084371|NCT00069823|141674478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0|STANDARD_ERROR_OF_MEAN|5.1||0.24|TWO_SIDED|95.0|-4.0|16.0|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||16.0|-4.0|0.24
71084372|NCT00069823|141674479|SUPERIORITY_OR_OTHER||Treatment Effect|-1.8||||0.04||95.0|-3.6|-0.1|||Regression, Linear|||||-0.1|-3.6|0.04
71084373|NCT00069823|141674480|SUPERIORITY_OR_OTHER||Treatment Effect|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.11|TWO_SIDED|95.0|0.0|0.2|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||0.2|0.0|0.11
71084374|NCT00069823|141674481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.01||0.11|TWO_SIDED|95.0|-0.05|-0.02|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||-0.02|-0.05|0.11
71084375|NCT00069823|141674482|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.33|TWO_SIDED|95.0|-0.2|0.1|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||0.1|-0.2|0.33
71084376|NCT00069823|141674483|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|0.6||0.16|TWO_SIDED|95.0|-2.0|0.4|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||0.4|-2.0|0.16
71084377|NCT00069823|141674484|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|0.78||0.56|TWO_SIDED|95.0|-1.1|2.2|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||2.2|-1.1|0.56
71084378|NCT00069823|141674485|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.76|TWO_SIDED|95.0|-0.05|0.07|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||0.07|-0.05|0.76
71084379|NCT00069823|141674486|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.39|TWO_SIDED|95.0|-0.8|0.3|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||0.3|-0.8|0.39
71084380|NCT01801111|141674498|OTHER|||||||0.0005|||||||Exact Clopper-Pearson CI|||Tests null hypothesis that the objective response rate (ORR) is equal to 35% versus the alternative hypothesis that the objective response rate was not equal to 35%.||||0.0005
71084381|NCT01801111|141674499|OTHER|||||||0.0599|TWO_SIDED||||||Exact Clopper-Pearson CI|||Tests null hypothesis that the ORR is equal to 35% versus the alternative hypothesis that the objective response rate was not equal to 35%.||||0.0599
71084382|NCT01801111|141674501|OTHER|||||||0.0001|||||||Exact Clopper-Pearson CI|||Tests null hypothesis that the ORR is equal to 35% versus the alternative hypothesis that the objective response rate was not equal to 35%.||||0.0001
71084383|NCT01223937|141674536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.028|TWO_SIDED|95.0|-0.42|-0.02||A priori threshold for significance was p\<=0.05.|ANCOVA|Repeated measures ANCOVA with treatment, visit (including a treatment-by-visit interaction term), and age stratification (\<65, ≥65 years) as factors.||"The trial was to be declared positive only if the 25 μg desmopressin group had a statistically significant positive effect as compared to placebo on both co-primary outcomes.~A summary of mean change in nocturnal voids, assessed longitudinally during 3 months of treatment, is presented below for the FAS using LOCF."||-0.02|-0.42|0.0280
71084384|NCT01223937|141674537|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.0061|TWO_SIDED|95.0|1.19|2.86||A priori threshold for significance was p\<=0.05.|Generalized Estimating Equation (GEE)|GEE Method with treatment, visit (including a treatment-by-visit interaction term), and age stratification (\<65, ≥65 years) as factors.||The trial was to be declared positive only if the 25 μg desmopressin group had a statistically significant positive effect as compared to placebo on both co-primary outcomes.||2.86|1.19|0.0061
71084385|NCT01223937|141674538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.0104|TWO_SIDED|95.0|-0.54|-0.07||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline nocturnal voids, using last observation carried forward.||Change from baseline in the adjusted mean number of nocturnal voids in the FAS using LOCF.||-0.07|-0.54|0.0104
71084386|NCT01223937|141674539|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.0586|TWO_SIDED|95.0|0.98|3.05||A priori threshold for significance was p\<=0.05.|Regression, Logistic|Logistical regression of 33% responder status adjusted for age (\<65, \>=65) and baseline nocturnal voids using last observation carried forward.||||3.05|0.98|0.0586
71084387|NCT01223937|141674540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.03||||0.0034|TWO_SIDED|95.0|16.35|81.7||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline time to first nocturnal void, using last observation carried forward.||||81.70|16.35|0.0034
71084388|NCT01223937|141674541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-83.56||||0.0031|TWO_SIDED|95.0|-138.74|-28.38||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline nocturnal urine volume, using last observation carried forward.||||-28.38|-138.74|0.0031
71084389|NCT01223937|141674542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-72.91||||0.1829|TWO_SIDED|95.0|-180.42|34.6||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline 24-hour urine volume, using last observation carried forward.||||34.60|-180.42|0.1829
71122558|NCT04384107|141750814|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 6B: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
71122559|NCT04384107|141750814|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 7F: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
70856345|NCT00545129|141199462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.58||1|TWO_SIDED|95.0|-2.48|2.48|||ANCOVA|||Change at Week 2 (Itching MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||2.48|-2.48|1.000
71084390|NCT00490971|141674598|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||The two treatment groups were compared using a weighted z-statistic based on rho-family of alpha spending function at information fraction of 85.0% at interim analysis analysis (rho=2.5) at 0.025 (1-sided) level. One-sided alpha at final was 0.0195.|Weighted Z- test|||Null hypothesis: there is no difference between Pali/Pali and Pali/Placebo in the time to recurrence of any mood symptoms related to bipolar I disorder. An interim analysis was performed when approximately 85% of the required number of recurrences were reported in Pali/Pali and Pali/Placebo treatment groups. A flexible group-sequential approach was adopted. The general family of alpha spending function based on the rho-family with rho=2.5 at overall type I error of 0.025 (1-sided) was employed.||||0.017
71122560|NCT04384107|141750814|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 9V: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
71122561|NCT04384107|141750814|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 14: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
71122562|NCT04384107|141750814|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 18C: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
71122563|NCT04384107|141750814|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 19A: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
70856346|NCT00545129|141199462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.0|<|0.001|TWO_SIDED|95.0|-1.01|-0.99|||ANCOVA|||Change at Week 4 (Itching MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||-0.99|-1.01|<0.001
71084391|NCT00490971|141674599|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The two treatment groups were compared using a weighted z-statistic based on rho-family of alpha spending function at information fraction of 81.9% at interim analysis analysis (rho=2.5) at 0.025 (1-sided) level. One-sided alpha at final was 0.0198.|Weighted z-test|||At the time of interim analysis of the primary efficacy endpoint, the proportion of recurrence of manic symptoms was 81.9% of the number of recurrence of manic symptoms at final analysis. A flexible group-sequential approach was adopted. The general family of alpha spending function based on the rho-family with rho=2.5 at overall type I error of 0.025 (1-sided) was employed.||||<0.001
71084392|NCT00490971|141674600|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.53|1.46||Cox proportional hazards regression was performed with treatment (Pali/Placebo, Pali/Pali) as a factor. The 2 treatment groups were compared by means of a hazard ratio (Pali/Placebo: Pali/Pali)|Regression, Cox|The percent of participants who reported recurrence of depressive symptoms was: 18% Pali/Placebo, 24% Pali/Pali.|Hazard ratio was estimated with Pali/Placebo in the numerator and Pali/Pali in the denominator|||1.46|0.53|
71084393|NCT00490971|141674601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5|||<|0.001|TWO_SIDED|95.0|-6.92|-1.98|||ANCOVA|ANCOVA model with treatment group (Pali/Pali, Pali/Placebo) and country as factors with baseline value as covariate||Change from Baseline (Maintenance Phase) to Endpoint (Maintenance Phase)||-1.98|-6.92|<0.001
71084394|NCT00490971|141674602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.763|TWO_SIDED|95.0|-1.87|2.55|||ANCOVA|ANCOVA Model with treatment (Pali/Pali, Pali/Placebo) and country as factors with baseline value as covariate||Change from Baseline (Maintenance Phase) to Endpoint (Maintenance Phase)||2.55|-1.87|0.763
71084395|NCT00490971|141674603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.7||||0.01|TWO_SIDED|95.0|1.4|10.09|||ANCOVA|ANCOVA Model with treatment (Pali/Pali, Pali/Placebo) and country as factors with baseline value as covariate||Change from Baseline (Maintenance Phase) to Endpoint (Maintenance Phase)||10.09|1.40|0.010
71084396|NCT00490971|141674604|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||ANCOVA|ANCOVA Model on ranks with treatment (Pali/Pali, Pali/Placebo) and country as factors with baseline value as covariate||Change from Baseline (Maintenance Phase) to Endpoint (Maintenance Phase)||||0.007
71084397|NCT03430856|141674651|NON_INFERIORITY|Change from baseline in HbA1c at 24 weeks of treatment, was analyzed using mixed model for repeated measures (MMRM) where all available post-baseline HbA1c measurements obtained up to Week 24 was entered as the dependent variables; visit and treatment were included as fixed factors, with Baseline HbA1c and stratification factor variables as covariates. Furthermore, the interaction terms of visit by treatment, visit by stratification factors and visit by Baseline HbA1c were included in the model.|Mean Difference (Net)|0.99|||||TWO_SIDED|95.0|0.502|1.47|||||Insulin Tregopil 45 mg - Insulin Aspart|||1.470|0.502|
71122564|NCT04384107|141750814|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 19F: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
71122565|NCT04384107|141750814|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.3|||||TWO_SIDED|95.0|-1.1|1.9||||||Serotype 23F: Participants With IgG ≥0.35 μg/mL||1.9|-1.1|
71122566|NCT04384107|141750814|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|94.8|||||TWO_SIDED|95.0|91.8|96.7||||||Serotype 22F: Participants With IgG ≥0.35 μg/mL||96.7|91.8|
71122567|NCT04384107|141750814|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|88.5|||||TWO_SIDED|95.0|84.5|91.6||||||Serotype 33F: Participants With IgG ≥0.35 μg/mL||91.6|84.5|
70856347|NCT00545129|141199462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.43||0.362|TWO_SIDED|95.0|-0.75|1.63|||ANCOVA|||Change at Week 2 (Difficulty with Urination MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||1.63|-0.75|0.362
70856348|NCT00545129|141199462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|4.08||1|TWO_SIDED|95.0|-51.87|51.87|||ANCOVA|||Change at Week 4 (Difficulty with Urination MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||51.87|-51.87|1.000
70856349|NCT00545129|141199462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.03|STANDARD_ERROR_OF_MEAN|0.1||0.031|TWO_SIDED|95.0|-3.3|-0.76|||ANCOVA|||Change at Week 4 (Retching/Vomiting MDR): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||-0.76|-3.30|0.031
71122568|NCT04384107|141750815|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.53|||||TWO_SIDED|95.0|0.47|0.59||||||Serotype 1: IgG GMC Ratio||0.59|0.47|
71122569|NCT04384107|141750815|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|1.71|||||TWO_SIDED|95.0|1.53|1.9||||||Serotype 3: IgG GMC Ratio||1.90|1.53|
71122570|NCT04384107|141750815|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.92|||||TWO_SIDED|95.0|0.8|1.05||||||Serotype 4: IgG GMC Ratio||1.05|0.80|
71122571|NCT04384107|141750815|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.67|||||TWO_SIDED|95.0|0.59|0.75||||||Serotype 5: IgG GMC Ratio||0.75|0.59|
71122572|NCT04384107|141750815|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.64|||||TWO_SIDED|95.0|0.56|0.73||||||Serotype 6A: IgG GMC Ratio||0.73|0.56|
71122573|NCT04384107|141750815|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.74|||||TWO_SIDED|95.0|0.65|0.84||||||Serotype 6B: IgG GMC Ratio||0.84|0.65|
71122574|NCT04384107|141750815|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.81|||||TWO_SIDED|95.0|0.71|0.92||||||Serotype 7F: IgG GMC Ratio||0.92|0.71|
71122575|NCT04384107|141750815|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.73|0.94||||||Serotype 9V: IgG GMC Ratio||0.94|0.73|
71084398|NCT03430856|141674651|NON_INFERIORITY|Non inferiority margin is 0.4%|Mean Difference (Net)|0.89|||||TWO_SIDED|95.0|0.414|1.37|||||Insulin Tregopil 30mg - Insulin Aspart|||1.370|0.414|
71084399|NCT02002871|141674670|SUPERIORITY_OR_OTHER|||||||0.0152|TWO_SIDED||||||t-test, 2 sided|||The statistical analysis was performed on the difference of the change from baseline of the Blue light treated plaque versus the Control plaque.||||0.0152
71084400|NCT04265261|141674702|SUPERIORITY||Risk Difference (RD)|1.19||||0.8586|TWO_SIDED|95.0|-11.86|14.23|||Cochran-Mantel-Haenszel|||||14.23|-11.86|0.8586
71084401|NCT04265261|141674702|SUPERIORITY||Risk Difference (RD)|-2.93||||0.6388|TWO_SIDED|95.0|-15.18|9.31|||Cochran-Mantel-Haenszel|||||9.31|-15.18|0.6388
71084402|NCT04547140|141674777|SUPERIORITY||Difference in percentages|3.3|||||TWO_SIDED|||||||||Percentage of Participants Dying||||
71084403|NCT04547140|141674777|SUPERIORITY||Difference in percentages|6.4|||||TWO_SIDED|||||||||Percentage of Participants Requiring ICU Admission||||
71084404|NCT04547140|141674778|SUPERIORITY||Difference in percentages|6.9|||||TWO_SIDED|||||||||Percentage of Participants Who are Dependent on High Flow Oxygen Devices||||
71084405|NCT04547140|141674778|SUPERIORITY||Difference in percentages|3.4|||||TWO_SIDED|||||||||Percentage of Participants Who are Dependent on Invasive Mechanical Ventilation||||
71084406|NCT04547140|141674779|SUPERIORITY||Least Squares (LS) Mean Difference|1.22||||0.1453|TWO_SIDED|95.0|-0.43|2.87||P-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Kenward-Roger|||Day 15||2.87|-0.43|0.1453
71084407|NCT04547140|141674779|SUPERIORITY||LS Mean Difference|0.21||||0.8015|TWO_SIDED|95.0|-1.44|1.86||P-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Kenward-Roger|||Day 29||1.86|-1.44|0.8015
71084408|NCT04547140|141674781|SUPERIORITY||LS Mean Difference of Duration|1.48||||0.5135|TWO_SIDED|95.0|-3.04|6.0||P-value was calculated using an analysis of variance (ANOVA) model, including the length of hospital stay (days) as a dependent variable and treatment group as a fixed effect.|ANOVA|||||6.00|-3.04|0.5135
71084409|NCT04547140|141674782|SUPERIORITY||LS Mean Difference of Duration|3.41||||0.1221|TWO_SIDED|95.0|-0.94|7.76||P-value was calculated using an ANOVA model, including the number of days in the ICU as a dependent variable and treatment group as a fixed effect.|ANOVA|||||7.76|-0.94|0.1221
71084410|NCT04547140|141674783|SUPERIORITY||LS Mean Difference of Duration|2.78||||0.3329|TWO_SIDED|95.0|-2.92|8.48||P-value was calculated using an ANOVA model, including the number of days on oxygen as a dependent variable and treatment group as a fixed effect.|ANOVA|||||8.48|-2.92|0.3329
71084411|NCT04547140|141674784|SUPERIORITY||LS Mean Difference of Duration|3.48||||0.1092|TWO_SIDED|95.0|-0.81|7.77||P-value was calculated using an ANOVA model, including the number of days on mechanical ventilation as a dependent variable and treatment group as a fixed effect.|ANOVA|||||7.77|-0.81|0.1092
71084412|NCT04547140|141674785|SUPERIORITY||LS Mean Difference|-0.63||||0.1189|TWO_SIDED|95.0|-1.43|0.17||P-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Kenward-Roger|||Day 15||0.17|-1.43|0.1189
71084413|NCT04547140|141674785|SUPERIORITY||LS Mean Difference|-0.85||||0.0341|TWO_SIDED|95.0|-1.64|-0.07||P-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Kenward-Roger|||Day 29||-0.07|-1.64|0.0341
71084414|NCT04547140|141674789|SUPERIORITY||Difference in percentages|1.9||||0.8809|TWO_SIDED|95.0|-24.1|28.3||P-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentages of participants experiencing sustained normalization of fever.|Chi-squared|||||28.3|-24.1|0.8809
71084415|NCT04033146|141674817|OTHER||||||<|0.001||||||Threshold was 0.05|ANOVA|||"H1. Bilateral ankle exoskeletons that provide 'motor-like' assistance will result in lower net metabolic power than those providing 'spring-like' assistance for young adults.~H2. Bilateral ankle exoskeletons that provide 'motor-like' assistance will result in lower net metabolic power than those providing 'spring-like' assistance for older adults."||||<0.001
71084416|NCT01064414|141674846|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.117||0.012|TWO_SIDED|95.0|-0.529|-0.066|||ANCOVA|||||-0.066|-0.529|0.012
71084417|NCT01064414|141674846|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.117|<|0.001|TWO_SIDED|95.0|-0.635|-0.174|||ANCOVA|||||-0.174|-0.635|<0.001
71084418|NCT01064414|141674847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.227|TWO_SIDED|95.0|0.73|3.77|||Regression, Logistic|||||3.77|0.73|0.227
71084419|NCT01064414|141674847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.69||||0.017|TWO_SIDED|95.0|1.19|6.04|||Regression, Logistic|||||6.04|1.19|0.017
71084420|NCT01064414|141674848|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-15.4|STANDARD_ERROR_OF_MEAN|6.638||0.021|TWO_SIDED|95.0|-28.45|-2.307|||ANCOVA|||||-2.307|-28.45|0.021
71084421|NCT01064414|141674848|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-12.2|STANDARD_ERROR_OF_MEAN|6.683||0.069|TWO_SIDED|95.0|-25.36|0.962|||ANCOVA|||||0.962|-25.36|0.069
71084422|NCT00249873|141674849|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.0133||95.0|0.81|0.98||Cumulative incidence functions in each treatment group were calculated using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. The primary comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of any component of the primary event for the clopidogrel group compared with the Placebo group.|||0.98|0.81|0.0133
71122576|NCT04384107|141750815|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.74|0.96||||||Serotype 14: IgG GMC Ratio||0.96|0.74|
70856350|NCT00545129|141199462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.15||0.886|TWO_SIDED|95.0|-0.28|0.32|||ANCOVA|||Change at Week 2 (Frequency Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.32|-0.28|0.886
70856351|NCT00545129|141199462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.21||0.66|TWO_SIDED|95.0|-0.52|0.33|||ANCOVA|||Change at Week 4 (Frequency Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.33|-0.52|0.660
70856352|NCT00545129|141199462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.238|TWO_SIDED|95.0|-0.54|0.14|||ANCOVA|||Change at Week 6 (Frequency Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.14|-0.54|0.238
71122577|NCT04384107|141750815|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|1.0|||||TWO_SIDED|95.0|0.87|1.14||||||Serotype 18C: IgG GMC Ratio||1.14|0.87|
71122578|NCT04384107|141750815|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.82|||||TWO_SIDED|95.0|0.73|0.92||||||Serotype 19A: IgG GMC Ratio||0.92|0.73|
70856353|NCT00545129|141199462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.14||0.36|TWO_SIDED|95.0|-0.42|0.16|||ANCOVA|||Change at Week 2 (Severity Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.16|-0.42|0.360
71122579|NCT04384107|141750815|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.75|0.94||||||Serotype 19F: IgG GMC Ratio||0.94|0.75|
71122580|NCT04384107|141750815|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.6|||||TWO_SIDED|95.0|0.52|0.7||||||Serotype 23F: IgG GMC Ratio||0.70|0.52|
71122581|NCT04384107|141750815|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|86.74|||||TWO_SIDED|95.0|77.61|96.95||||||Serotype 22F: IgG GMC Ratio||96.95|77.61|
70856354|NCT00545129|141199462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.17||0.278|TWO_SIDED|95.0|-0.16|0.54|||ANCOVA|||Change at Week 4 (Severity Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.54|-0.16|0.278
70856355|NCT00545129|141199462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.15||0.809|TWO_SIDED|95.0|-0.34|0.27|||ANCOVA|||Change at Week 6 (Severity Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.27|-0.34|0.809
71122582|NCT04384107|141750815|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|45.44|||||TWO_SIDED|95.0|40.07|51.54||||||Serotype 33F: IgG GMC Ratio||51.54|40.07|
71122583|NCT04384107|141750816|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.66|||||TWO_SIDED|95.0|0.55|0.78||||||Serotype 1: OPA GMT Ratio||0.78|0.55|
70856356|NCT00545129|141199462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.18||0.944|TWO_SIDED|95.0|-0.35|0.38|||ANCOVA|||Change at Week 2 (Bother Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.38|-0.35|0.944
70856357|NCT00545129|141199462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.26||0.892|TWO_SIDED|95.0|-0.48|0.55|||ANCOVA|||Change at Week 4 (Bother Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.55|-0.48|0.892
70856358|NCT00545129|141199462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.21||0.884|TWO_SIDED|95.0|-0.39|0.45|||ANCOVA|||Change at Week 6 (Bother Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.45|-0.39|0.884
71122584|NCT04384107|141750816|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.23|1.59||||||Serotype 3: OPA GMT Ratio||1.59|1.23|
71122585|NCT04384107|141750816|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.1||||||Serotype 4: OPA GMT Ratio||1.10|0.85|
71122586|NCT04384107|141750816|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.91|||||TWO_SIDED|95.0|0.8|1.04||||||Serotype 5: OPA GMT Ratio||1.04|0.80|
71122587|NCT04384107|141750816|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.76|||||TWO_SIDED|95.0|0.65|0.89||||||Serotype 6A: OPA GMT Ratio||0.89|0.65|
71122588|NCT04384107|141750816|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMC Ratio|0.81|||||TWO_SIDED|95.0|0.69|0.95||||||Serotype 6B: OPA GMT Ratio||0.95|0.69|
71084423|NCT00249873|141674850|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|||<|0.001||95.0|0.62|0.83||Cumulative incidence functions in each treatment group were calculated using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. The primary comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of stroke for the clopidogrel group compared with the Placebo group.|||0.83|0.62|<0.001
71084424|NCT00249873|141674851|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.696||95.0|0.89|1.08||Cumulative incidence functions in each treatment group were calculated using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. The primary comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of death from any cause for the clopidogrel group compared with the Placebo group.|||1.08|0.89|0.696
71084425|NCT00249873|141674852|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
71084426|NCT03286218|141674853|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 14 mm.|Least Squares (LS) Mean Difference|32.4|||||TWO_SIDED|90.0|28.4|36.4||||||||36.4|28.4|
71122589|NCT04384107|141750816|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMC Ratio|0.81|||||TWO_SIDED|95.0|0.7|0.95||||||Serotype 7F: OPA GMT Ratio||0.95|0.70|
71122590|NCT04384107|141750816|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.82|||||TWO_SIDED|95.0|0.71|0.94||||||Serotype 9V: OPA GMT Ratio||0.94|0.71|
71122591|NCT04384107|141750816|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.15|||||TWO_SIDED|95.0|0.97|1.38||||||Serotype 14: OPA GMT Ratio||1.38|0.97|
71122592|NCT04384107|141750816|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.9|1.11||||||Serotype 18C: OPA GMT Ratio||1.11|0.90|
70856359|NCT00545129|141199462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.13||0.919|TWO_SIDED|95.0|-0.26|0.28|||ANCOVA|||Change at Week 2 (MDA Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.28|-0.26|0.919
71084427|NCT03286218|141674853|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses vs Placebo is 14 mm.|LS Mean Difference|15.6|||||TWO_SIDED|90.0|11.7|19.6||||||||19.6|11.7|
71084428|NCT03286218|141674853|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses vs Placebo is 14 mm.|LS Mean Difference|20.3|||||TWO_SIDED|90.0|16.3|24.3||||||||24.3|16.3|
71084429|NCT03286218|141674853|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses vs Placebo is 14 mm.|LS Mean Difference|23.6|||||TWO_SIDED|90.0|19.6|27.6||||||||27.6|19.6|
71122593|NCT04384107|141750816|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.68|||||TWO_SIDED|95.0|0.61|0.77||||||Serotype 19A: OPA GMT Ratio||0.77|0.61|
71122594|NCT04384107|141750816|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.93|||||TWO_SIDED|95.0|0.84|1.04||||||Serotype 19F: OPA GMT Ratio||1.04|0.84|
71122595|NCT04384107|141750816|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.63|||||TWO_SIDED|95.0|0.53|0.74||||||Serotype 23F: OPA GMT Ratio||0.74|0.53|
71122596|NCT04384107|141750816|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|560.46|||||TWO_SIDED|95.0|474.05|662.63||||||Serotype 22F: OPA GMT Ratio||662.63|474.05|
71122597|NCT04384107|141750816|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|196.14|||||TWO_SIDED|95.0|141.85|271.21||||||Serotype 33F: OPA GMT Ratio||271.21|141.85|
71122598|NCT04384107|141750817|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.53|||||TWO_SIDED|95.0|0.38|0.75||||||Serotype 1: OPA GMT Ratio||0.75|0.38|
71122599|NCT04384107|141750817|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.62|||||TWO_SIDED|95.0|1.28|2.03||||||Serotype 3: OPA GMT Ratio||2.03|1.28|
71122600|NCT04384107|141750817|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.72|||||TWO_SIDED|95.0|0.57|0.93||||||Serotype 4: OPA GMT Ratio||0.93|0.57|
71122601|NCT04384107|141750817|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.86|||||TWO_SIDED|95.0|0.66|1.13||||||Serotype 5: OPA GMT Ratio||1.13|0.66|
71122602|NCT04384107|141750817|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.72|||||TWO_SIDED|95.0|0.57|0.91||||||Serotype 6A: OPA GMT Ratio||0.91|0.57|
71122603|NCT04384107|141750817|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.66|||||TWO_SIDED|95.0|0.52|0.83||||||Serotype 6B: OPA GMT Ratio||0.83|0.52|
71122604|NCT04384107|141750817|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.86|||||TWO_SIDED|95.0|0.68|1.07||||||Serotype 7F: OPA GMT Ratio||1.07|0.68|
70856360|NCT00545129|141199462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.19||0.752|TWO_SIDED|95.0|-0.33|0.45|||ANCOVA|||Change at Week 4 (MDA Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.45|-0.33|0.752
70856361|NCT00545129|141199462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.14||0.715|TWO_SIDED|95.0|-0.34|0.24|||ANCOVA|||Change at Week 6 (MDA Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.24|-0.34|0.715
71084430|NCT03286218|141674853|NON_INFERIORITY|The non-inferiority (NI) margin for Alprazolam and Lasmiditan 100 mg dose is 5 mm.|LS Mean Difference|16.8|||||TWO_SIDED|90.0|12.8|20.8||||||||20.8|12.8|
71084431|NCT03286218|141674853|NON_INFERIORITY|The non-inferiority (NI) margin for Alprazolam and Lasmiditan 200 mg dose is 5 mm.|LS Mean Difference|12.1|||||TWO_SIDED|90.0|8.1|16.1||||||||16.1|8.10|
71084432|NCT03286218|141674853|NON_INFERIORITY|The non-inferiority (NI) margin for Alprazolam and Lasmiditan 400 mg dose is 5 mm.|LS Mean Difference|8.79|||||TWO_SIDED|90.0|4.8|12.8||||||||12.8|4.8|
71084433|NCT03286218|141674856|OTHER||LS Mean Difference|33.1|||||TWO_SIDED|90.0|28.5|37.7||||||Overall Drug Liking||37.7|28.5|
71084434|NCT03286218|141674856|OTHER||LS Mean Difference|18.6|||||TWO_SIDED|90.0|14.0|23.2||||||Overall Drug Liking||23.2|14.0|
71084435|NCT03286218|141674856|OTHER||LS Mean Difference|19.1|||||TWO_SIDED|90.0|14.5|23.8||||||Overall Drug Liking||23.8|14.5|
71084436|NCT03286218|141674856|OTHER||LS Mean Difference|24.3|||||TWO_SIDED|90.0|19.7|28.9||||||Overall Drug Liking||28.9|19.7|
71084437|NCT03286218|141674856|OTHER||LS Mean Difference|34.0|||||TWO_SIDED|90.0|29.1|38.9||||||Take drug again||38.9|29.1|
71084438|NCT03286218|141674856|OTHER||LS Mean Difference|19.1|||||TWO_SIDED|90.0|14.2|24.0||||||Take drug again||24.0|14.2|
71084439|NCT03286218|141674856|OTHER||LS Mean Difference|20.6|||||TWO_SIDED|90.0|15.7|25.6||||||Take drug again||25.6|15.7|
71084440|NCT03286218|141674856|OTHER||LS Mean Difference|25.3|||||TWO_SIDED|90.0|20.3|30.2||||||Take drug again||30.2|20.3|
71084441|NCT03286218|141674856|OTHER||LS Mean Difference|69.7|||||TWO_SIDED|90.0|62.1|77.4||||||Good effects||77.4|62.1|
71084442|NCT03286218|141674856|OTHER||LS Mean Difference|35.5|||||TWO_SIDED|90.0|27.9|43.2||||||Good effects||43.2|27.9|
71084443|NCT03286218|141674856|OTHER||LS Mean Difference|52.0|||||TWO_SIDED|90.0|44.4|59.7||||||Good effects||59.7|44.4|
71084444|NCT03286218|141674856|OTHER||LS Mean Difference|53.0|||||TWO_SIDED|90.0|45.4|60.6||||||Good effects||60.6|45.4|
71084445|NCT03286218|141674856|OTHER||LS Mean Difference|20.4|||||TWO_SIDED|90.0|13.6|27.2||||||Bad effects||27.2|13.6|
71084446|NCT03286218|141674856|OTHER||LS Mean Difference|5.04|||||TWO_SIDED|90.0|-1.76|11.8||||||Bad effects||11.8|-1.76|
71084447|NCT03286218|141674856|OTHER||LS Mean Difference|7.28|||||TWO_SIDED|90.0|0.487|14.1||||||Bad effects||14.1|0.487|
71084448|NCT03286218|141674856|OTHER||LS Mean Difference|12.5|||||TWO_SIDED|90.0|5.69|19.3||||||Bad effects||19.3|5.69|
71084449|NCT03286218|141674856|OTHER||LS Mean Difference|75.4|||||TWO_SIDED|90.0|67.2|83.5||||||Any effects||83.5|67.2|
71084450|NCT03286218|141674856|OTHER||LS Mean Difference|44.9|||||TWO_SIDED|90.0|36.8|53.0||||||Any effects||53.0|36.8|
71084451|NCT03286218|141674856|OTHER||LS Mean Difference|56.8|||||TWO_SIDED|90.0|48.7|64.9||||||Any effects||64.9|48.7|
71084452|NCT03286218|141674856|OTHER||LS Mean Difference|64.8|||||TWO_SIDED|90.0|56.7|73.0||||||Any effects||73.0|56.7|
71084453|NCT03286218|141674856|OTHER||LS Mean Difference|68.6|||||TWO_SIDED|90.0|60.6|76.6||||||High||76.6|60.6|
71084454|NCT03286218|141674856|OTHER||LS Mean Difference|34.4|||||TWO_SIDED|90.0|26.4|42.4||||||High||42.4|26.4|
71084455|NCT03286218|141674856|OTHER||LS Mean Difference|47.5|||||TWO_SIDED|90.0|39.5|55.5||||||High||55.5|39.5|
71084456|NCT03286218|141674856|OTHER||LS Mean Difference|58.4|||||TWO_SIDED|90.0|50.4|66.3||||||High||66.3|50.4|
71084457|NCT03286218|141674857|SUPERIORITY||Mean Difference (Final Values)|0.0|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71084458|NCT03286218|141674857|SUPERIORITY||Median Difference (Final Values)|0.0||||0.0781|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0781
71084459|NCT03286218|141674857|SUPERIORITY||Median Difference (Final Values)|0.0||||0.0625|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0625
71084460|NCT03286218|141674857|SUPERIORITY||Median Difference (Final Values)|0.0||||0.0098|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0098
71084461|NCT03286218|141674858|OTHER||LS Mean Difference|-29.9|||||TWO_SIDED|90.0|-34.0|-25.9||||||Alertness/drowsiness||-25.9|-34.0|
71084462|NCT03286218|141674858|OTHER||LS Mean Difference|-16.9|||||TWO_SIDED|90.0|-20.9|-12.8||||||Alertness/drowsiness||-12.8|-20.9|
71084463|NCT03286218|141674858|OTHER||LS Mean Difference|-19.6|||||TWO_SIDED|90.0|-23.6|-15.5||||||Alertness/drowsiness||-15.5|-23.6|
71084464|NCT03286218|141674858|OTHER||LS Mean Difference|-24.8|||||TWO_SIDED|90.0|-28.8|-20.8||||||Alertness/drowsiness||-20.8|-28.8|
71084465|NCT03286218|141674858|OTHER||LS Mean Difference|-30.8|||||TWO_SIDED|90.0|-35.0|-26.5||||||Agitation/relaxation||-26.5|-35.0|
71084466|NCT03286218|141674858|OTHER||LS Mean Difference|-19.5|||||TWO_SIDED|90.0|-23.7|-15.3||||||Agitation/relaxation||-15.3|-23.7|
71084467|NCT03286218|141674858|OTHER||LS Mean Difference|-21.7|||||TWO_SIDED|90.0|-25.9|-17.5||||||Agitation/relaxation||-17.5|-25.9|
71084468|NCT03286218|141674858|OTHER||LS Mean Difference|-28.8|||||TWO_SIDED|90.0|-33.0|-24.5||||||Agitation/relaxation||-24.5|-33.0|
71084469|NCT02762084|141674872|OTHER|Pairwise comparison||||||0.03|||||||ANCOVA|ANCOVA with treatment group as a factor and Baseline value as a covariate||at Week 26||||0.030
71084470|NCT02762084|141674872|OTHER|Pairwise comparison||||||0.756|||||||ANCOVA|ANCOVA with treatment group as a factor and Baseline value as a covariate||at Week 26||||0.756
71084471|NCT02762084|141674873|OTHER|Pairwise comparison||||||0.5|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 6||||0.500
71084472|NCT02762084|141674873|OTHER|Pairwise comparison||||||0.681|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 6||||0.681
71084473|NCT02762084|141674877|OTHER|One-sided comparison||||||0.048|||||||Mann Whitey U|||at Week 26||||0.048
71084474|NCT02762084|141674877|OTHER|Two-sided comparison||||||0.096|||||||Mann Whitey U|||at Week 26||||0.096
71084475|NCT02762084|141674878|OTHER|Two-sided comparison||||||0.008|||||||Mann Whitey U|||at Week 26||||0.008
71084476|NCT01619852|141674902|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||.19
71084477|NCT01619852|141674903|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
71122605|NCT04384107|141750817|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.65|||||TWO_SIDED|95.0|0.5|0.84||||||Serotype 9V: OPA GMT Ratio||0.84|0.50|
71084478|NCT01619852|141674904|SUPERIORITY_OR_OTHER_LEGACY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
70856362|NCT00545129|141199463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.47||0.666|TWO_SIDED|95.0|-0.77|1.18|||ANCOVA|||Change at Week 1 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.18|-0.77|0.666
71084479|NCT01619852|141674904|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||McGill Questionnaire-Sensory-discriminative dimension||||0.69
71084480|NCT01619852|141674904|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||McGill Questionnaire-affective dimension||||0.75
71084481|NCT01619852|141674904|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Brief Pain Inventory||||0.81
71084482|NCT01619852|141674905|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||.19
71084483|NCT01619852|141674906|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||.29
71084484|NCT02168491|141674914|SUPERIORITY_OR_OTHER||||||<|0.02|||||||paired t test|||||||<0.02
71084485|NCT02168491|141674915|SUPERIORITY_OR_OTHER|||||||0.24|||||||paired t test|||||||0.24
71084486|NCT02168491|141674916|SUPERIORITY_OR_OTHER|||||||0.28|||||||paired t test|||||||0.28
71122606|NCT04384107|141750817|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.48|||||TWO_SIDED|95.0|1.16|1.9||||||Serotype 14: OPA GMT Ratio||1.90|1.16|
71122607|NCT04384107|141750817|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.19|||||TWO_SIDED|95.0|0.95|1.48||||||Serotype 18C: OPA GMT Ratio||1.48|0.95|
71084487|NCT01096160|141674919|OTHER|Difference in change from baseline in SBP (TWA\^0-24hrs)|Mean Difference (Final Values)|-7.08||||0.1194|TWO_SIDED|90.0|-17.1|2.92|||Linear mixed effects model|||||2.92|-17.1|0.1194
71084488|NCT01096160|141674919|OTHER|Difference in change from baseline in SBP (TWA\^0-24hrs)|Mean Difference (Final Values)|-13.1||||0.0224|TWO_SIDED|90.0|-23.7|-2.48|||Linear mixed effects model|||||-2.48|-23.7|0.0224
71084489|NCT01096160|141674919|OTHER|Difference in change from baseline in SBP (TWA\^0-24hrs)|Mean Difference (Final Values)|0.33||||0.4791|TWO_SIDED|90.0|-10.3|10.91|||Linear mixed effects model|||||10.91|-10.3|0.4791
71084490|NCT01096160|141674919|OTHER|Difference in change from baseline in SBP (TWA\^0-24hrs)|Mean Difference (Final Values)|-8.21||||0.0705|TWO_SIDED|90.0|-17.4|1.01|||Linear mixed effcts model|||Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Panel D was completed prior to initiation of Panel E.||1.01|-17.4|0.0705
71084491|NCT01096160|141674920|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|3.85||||0.1161|TWO_SIDED|90.0|-1.51|9.22|||Linear mixed effects model|||||9.22|-1.51|0.1161
71084492|NCT01096160|141674920|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|7.28||||0.0189|TWO_SIDED|90.0|1.6|12.97|||Linear mixed effects model|||||12.97|1.60|0.0189
71084493|NCT01096160|141674920|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|0.26||||0.4689|TWO_SIDED|90.0|-5.42|5.95|||Linear mixed effects model|||||5.95|-5.42|0.4689
71084494|NCT01096160|141674920|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|4.06||||0.0869|TWO_SIDED|90.0|-0.89|9.01|||Linear mixed effects model|||Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Panel D was completed prior to initiation of Panel E.||9.01|-0.89|0.0869
71084495|NCT01096160|141674921|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|-9.87||||0.003|TWO_SIDED|90.0|-15.7|-4.09|||Linear mixed effects model|||||-4.09|-15.7|0.003
71084496|NCT01096160|141674921|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|-11.2||||0.002|TWO_SIDED|90.0|-17.3|-5.1|||Linear mixed effects model|||||-5.10|-17.3|0.002
71084497|NCT01096160|141674921|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|-5.18||||0.08|TWO_SIDED|90.0|-11.3|0.95|||Linear mixed effcts model|||||0.95|-11.3|0.080
71122608|NCT04384107|141750817|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.78|||||TWO_SIDED|95.0|0.6|1.01||||||Serotype 19A: OPA GMT Ratio||1.01|0.60|
71122609|NCT04384107|141750817|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.23|||||TWO_SIDED|95.0|1.0|1.52||||||Serotype 19F: OPA GMT Ratio||1.52|1.00|
71122610|NCT04384107|141750817|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.37|||||TWO_SIDED|95.0|0.28|0.49||||||Serotype 23F: OPA GMT Ratio||0.49|0.28|
71084498|NCT01096160|141674921|OTHER|Difference in change from baseline in AIx (TWA\^0-24hrs)|Mean Difference (Final Values)|-6.79||||0.019|TWO_SIDED|90.0|-12.1|-1.46|||Linear mixed effcts model|||Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Panel D was completed prior to initiation of Panel E.||-1.46|-12.1|0.019
71084499|NCT01096160|141674922|OTHER|Difference in change from baseline in cGMP|Geometric Mean Ratio|1.28||||0.318|TWO_SIDED|90.0|0.53|3.05|||Linear mixed effects model|||||3.05|0.53|0.318
71084500|NCT01096160|141674922|OTHER|Difference in change from baseline in cGMP|Geometric Mean Ratio|1.66||||0.17|TWO_SIDED|90.0|0.66|4.17|||Linear mixed effects model|||||4.17|0.66|0.17
71084501|NCT01096160|141674922|OTHER|Difference in change from baseline in cGMP|Geometric Mean Ratio|0.41||||0.054|TWO_SIDED|90.0|0.16|1.02|||Linear mixed effcts model|||||1.02|0.16|0.054
71084502|NCT01096160|141674922|OTHER|Difference in change from baseline in cGMP|Geometric Mean Ratio|0.78||||0.297|TWO_SIDED|90.0|0.35|1.73|||Linear mixed effcts model|||Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Panel D was completed prior to initiation of Panel E.||1.73|0.35|0.297
71084503|NCT00705757|141674937|SUPERIORITY_OR_OTHER|||||||0.769|TWO_SIDED||||||ANOVA|||One way ANOVA of Upper Lid||||0.769
71084504|NCT00705757|141674937|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|95.0|||||ANOVA|||One way ANOVA of Lower Lid||||0.230
71084505|NCT00705757|141674937|SUPERIORITY_OR_OTHER|||||||0.851|TWO_SIDED|95.0|||||ANOVA|||One way ANOVA of cheek/face||||0.851
71084506|NCT03193047|141674938|SUPERIORITY||Least squares mean difference|-30.261|STANDARD_ERROR_OF_MEAN|5.502|<|0.001|TWO_SIDED|95.0|-41.324|-19.199|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|||-19.199|-41.324|<0.001
71084507|NCT03193047|141674939|SUPERIORITY||Lease squares mean difference|-35.884|STANDARD_ERROR_OF_MEAN|5.159|<|0.001|TWO_SIDED|95.0|-46.303|-25.466|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|||-25.466|-46.303|<0.001
71122611|NCT04384107|141750817|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|155.88|||||TWO_SIDED|95.0|101.84|238.59||||||Serotype 22F: OPA GMT Ratio||238.59|101.84|
71122612|NCT04384107|141750817|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|16.81|||||TWO_SIDED|95.0|11.74|24.08||||||Serotype 33F: OPA GMT Ratio||24.08|11.74|
71122613|NCT02698371|141750829|EQUIVALENCE|alpha value of 0.05 was considered||||||0.025|||||||McNemar|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance between baseline and 24 month follow-up;||||0.025
71122614|NCT02698371|141750829|EQUIVALENCE|alpha value of 0.05 was considered||||||0.189|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE (G1) and MM-SE(G4G6) result in similar restorations (aesthetic, functional and biologic) success rates;||||0.189
71122615|NCT02698371|141750829|EQUIVALENCE|alpha value of 0.05 was considered||||||0.189|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE (G1) and MM-SE (G4G6) adhesives result in similar restoration retention rates;||||0.189
71084508|NCT03193047|141674940|SUPERIORITY||Least squares mean difference|-38.25|STANDARD_ERROR_OF_MEAN|5.602|<|0.001|TWO_SIDED|95.0|-49.558|-26.944|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|Month 1||-26.944|-49.558|<0.001
71084509|NCT03193047|141674940|SUPERIORITY||Least squares mean difference|-29.9|STANDARD_ERROR_OF_MEAN|5.606|<|0.001|TWO_SIDED|95.0|-41.176|-18.626|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|Month 2||-18.626|-41.176|<0.001
71122616|NCT02698371|141750829|EQUIVALENCE|alpha value of 0.05 was considered||||||0.025|||||||McNemar|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance from baseline to 24 month follow-up;||||0.025
70856363|NCT00545129|141199463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.49||0.745|TWO_SIDED|95.0|-0.86|1.18|||ANCOVA|||Change at Week 2 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.18|-0.86|0.745
71084510|NCT03193047|141674941|SUPERIORITY||Least squares mean difference|-27.031|STANDARD_ERROR_OF_MEAN|5.15|<|0.001|TWO_SIDED|95.0|-37.509|-16.553|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|Apo B at Month 1||-16.553|-37.509|<0.001
71084511|NCT03193047|141674941|SUPERIORITY||Least squares mean difference|-24.469|STANDARD_ERROR_OF_MEAN|4.33|<|0.001|TWO_SIDED|95.0|-33.225|-15.713|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|Apo B at Month 2||-15.713|-33.225|<0.001
71122617|NCT02698371|141750829|EQUIVALENCE|alpha value of 0.05 was considered||||||0.747|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE-EE (G2) and MM-ER (G3G5) result in similar restorations (aesthetic, functional and biologic) success rates;||||0.747
71122618|NCT02698371|141750829|EQUIVALENCE|alpha value of 0.05 was considered||||||0.747|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE-EE (G2) and MM-ER (G3G5) result in similar restoration retention rates;||||0.747
71084512|NCT03193047|141674941|SUPERIORITY||Least squares mean difference|-31.64|STANDARD_ERROR_OF_MEAN|4.689|<|0.001|TWO_SIDED|95.0|-41.116|-22.163|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|non-HDL-C at Month 1||-22.163|-41.116|<0.001
71084513|NCT03193047|141674941|SUPERIORITY||Least squares mean difference|-24.246|STANDARD_ERROR_OF_MEAN|4.838|<|0.001|TWO_SIDED|95.0|-33.987|-14.505|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|non-HDL-C at Month 2||-14.505|-33.987|<0.001
71084514|NCT03193047|141674941|SUPERIORITY||Least squares mean difference|-21.941|STANDARD_ERROR_OF_MEAN|3.572|<|0.001|TWO_SIDED|95.0|-29.153|-14.729|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|TC at Month 1||-14.729|-29.153|<0.001
71084515|NCT03193047|141674941|SUPERIORITY||Least squares mean difference|-17.52|STANDARD_ERROR_OF_MEAN|3.809|<|0.001|TWO_SIDED|95.0|-25.201|-9.839|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|TC at Month 2||-9.839|-25.201|<0.001
71084516|NCT03193047|141674942|SUPERIORITY||Median treatment difference|-32.479|STANDARD_ERROR_OF_MEAN|17.395||0.046|TWO_SIDED|95.0|-70.524|-2.339|||Wilcoxon rank sum test||The median treatment difference (location shift) and the 95% confidence limits are from Hodges-Lehmann estimates.|hs-CRP at Month 1||-2.339|-70.524|0.046
70856364|NCT00545129|141199463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.48||0.749|TWO_SIDED|95.0|-1.14|0.83|||ANCOVA|||Change at Week 4 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.83|-1.14|0.749
71084517|NCT03193047|141674942|SUPERIORITY||Median treatment difference|-28.512|STANDARD_ERROR_OF_MEAN|12.124||0.029|TWO_SIDED|95.0|-51.455|-3.93|||Wilcoxon rank sum test||The median treatment difference (location shift) and the 95% confidence limits are from Hodges-Lehmann estimates.|hs-CRP at Month 2||-3.930|-51.455|0.029
71084518|NCT00186485|141674978|SUPERIORITY_OR_OTHER||||||<|0.001||||||Repeated Measures ANOVAs over the course of the TMS treatments, by severity of depression on the HAM-D rating scale: total scores (F (4,96) = 19.88, p \< .001) over the 4 week treatment period.|ANOVA|Repeated Measures Anova||ANOVA with partial eta accounts for multiple repeated measures over the course of treatment.||||<0.001
71084519|NCT00186485|141674979|SUPERIORITY_OR_OTHER||||||<|0.01||||||Repeated Measures ANOVAs over the course of the TMS treatments, by severity of depression on the BDI total scores (F (4,96) = 19.35, p \< .001) over the 4 week treatment period.,|ANOVA|||Repeated measures ANOVA with partial eta; accounts for multiple repeated measures over the course of treatment.||||<0.01
71084520|NCT00186485|141674980|SUPERIORITY_OR_OTHER||||||<|0.01||||||Repeated Measures ANOVAs over the course of the TMS treatments, by severity of depression on the CGI scores (F (4,88) = 5.31, p \< .01) over the 4 week treatment period.|ANOVA|||Repeated Measures ANOVA with partial eta; p value was adjusted for multiple comparisons over the course of treatment||||<0.01
71084521|NCT02533934|141674983|EQUIVALENCE|Equivalence margin is defined by the a priori threshold for statistical significance.|||||<|0.01|||||||Kruskal-Wallis|||APRI change from baseline to last follow-up||||<.01
71084522|NCT02533934|141674983|EQUIVALENCE|Equivalence margin is defined by the a priori threshold for statistical significance.|||||<|0.01|||||||Kruskal-Wallis|||APRI change from baseline to last follow-up||||<.01
71084523|NCT02533934|141674983|EQUIVALENCE|Equivalence margin is defined by the a priori threshold for statistical significance|||||<|0.01|||||||Kruskal-Wallis|||FIB4 change from baseline to last follow-up||||<.01
71084524|NCT02533934|141674983|EQUIVALENCE|Equivalence margin is defined by the a priori threshold for statistical significance|||||<|0.01|||||||Kruskal-Wallis|||FIB4 change from baseline to last follow-up||||<.01
71084525|NCT02533934|141674985|EQUIVALENCE|Equivalence margin is defined by the a priori threshold for statistical significance.|||||<|0.001|||||||Wilcoxon (Signed Rank Test)|||||||<0.001
71084526|NCT01922258|141674989|SUPERIORITY||Treatment Difference|-2.34|||=|0.1454|TWO_SIDED|95.0|-5.49|0.82|||Mixed-effect model repeated measure|||||0.82|-5.49|=0.1454
71084527|NCT04552132|141674998|SUPERIORITY|||||||0.63|||||||Fisher Exact|||||||0.63
71084528|NCT04552132|141674999|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71084529|NCT04552132|141675000|SUPERIORITY|||||||0.63|||||||Fisher Exact|||||||0.63
71122619|NCT02698371|141750829|EQUIVALENCE|alpha value of 0.05 was considered||||||0.07|||||||Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance;||||0.070
71122620|NCT02698371|141750829|EQUIVALENCE|alpha value of 0.05 was considered||||||0.07||||||Applied for rows/Categories- Acceptance Vs Not Acceptance Functional-FDI comparison between G1G2 and G3G4 and G5G6 Arms success rate from baseline to 24 month recall. For Esthetic and Biological-FDI comparison p values were \> 0.05. Adjusted P-values.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar restorations (aesthetic, functional and biologic) success rates;||||0.070
71122621|NCT02698371|141750829|EQUIVALENCE|alpha value of 0.05 was considered||||||0.07||||||Applied for rows/Categories- Acceptance Vs Not Acceptance Retention-FDI comparison between G1G2 and G3G4 and G5G6 Arms retention rate from baseline to 24 month recall. Adjusted P-values.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar restoration retention rates;||||0.070
71122622|NCT02698371|141750830|EQUIVALENCE|alpha value of 0.05 was considered||||||0.025|||||||McNemar|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance;||||0.025
71084530|NCT04552132|141675001|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71084531|NCT04552132|141675002|SUPERIORITY|||||||0.57|||||||Fisher Exact|||||||0.57
71084532|NCT04552132|141675003|SUPERIORITY|||||||0.6|||||||Fisher Exact|||||||0.60
71084533|NCT04552132|141675004|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71084534|NCT04552132|141675005|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71084535|NCT04552132|141675006|SUPERIORITY|||||||0.18|||||||Chi-squared|||||||0.18
71084536|NCT04552132|141675007|SUPERIORITY|||||||0.4993|||||||Chi-squared|||||||.4993
71084537|NCT04552132|141675008|SUPERIORITY|||||||0.52|||||||t-test, 2 sided|||||||0.52
71084538|NCT04552132|141675009|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||.70
71084539|NCT02256839|141675010|EQUIVALENCE|A 2x2 contingency table with 95% CI.|2 x 2 contingency table|98.1|||||TWO_SIDED|95.0|95.3|99.3||||||||99.3|95.3|
71084540|NCT02256839|141675010|EQUIVALENCE|A 2x2 contingency table with 95% CI|2 x 2 contingency table|96.1|||||TWO_SIDED|95.0|85.4|99.3||||||||99.3|85.4|
71122623|NCT02698371|141750830|EQUIVALENCE|alpha value of 0.05 was considered||||||0.189|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE (G1) and MM-SE(G4G6) result in similar restorations (aesthetic, functional and biologic) success rates;||||0.189
71122624|NCT02698371|141750830|EQUIVALENCE|alpha value of 0.05 was considered||||||0.189|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE (G1) and MM-SE (G4G6) adhesives result in similar restoration retention rates;||||0.189
71122625|NCT02698371|141750830|EQUIVALENCE|alpha value of 0.05 was considered||||||0.025|||||||McNemar|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance;||||0.025
71122626|NCT02698371|141750830|EQUIVALENCE|alpha value of 0.05 was considered||||||0.154|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE-EE (G2) and MM-ER (G3G5) result in similar restorations (aesthetic, functional and biologic) success rates;||||0.154
71122627|NCT02698371|141750830|EQUIVALENCE|alpha value of 0.05 was considered||||||0.747|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE-EE (G2) and MM-ER (G3G5) result in similar restoration retention rates;||||0.747
71122628|NCT02698371|141750830|EQUIVALENCE|alpha value of 0.05 was considered||||||0.07|||||||Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance;||||0.070
71122629|NCT02698371|141750830|EQUIVALENCE|alpha value of 0.05 was considered||||||0.07|||||||Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar restorations (aesthetic, functional and biologic) success rates;||||0.070
71122630|NCT02698371|141750830|EQUIVALENCE|alpha value of 0.05 was considered||||||0.07|||||||Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar restoration retention rates;||||0.070
71122631|NCT02698371|141750831|EQUIVALENCE|An alpha value of 0.05 was considered||||||1||||||Applied for rows/Categories- Acceptance Vs Not Acceptance Esthetic of FDI and of USPHS comparison; Applied to G1G2; G3G4 and G5G6 separately.|Chi-squared|||H0: FDI or USPHS criteria Esthetic outcomes not differ at 24th month follow-up regarding Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) adhesive, with SE or SE-ER/ER modes.||||1.000
71122632|NCT02698371|141750831|EQUIVALENCE|An alpha value of 0.05 was considered||||||1||||||Applied for rows/Categories- Acceptance Vs Not Acceptance Functional of FDI and of USPHS comparison; Applied to G1G2; G3G4 and G5G6 separately.|Chi-squared|||H0: FDI or USPHS criteria Functional outcomes not differ at 24th month follow-up regarding Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) adhesive, with SE or SE-ER/ER modes.||||1.000
71122633|NCT02698371|141750831|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.998||||||Applied for rows/Categories- Acceptance Vs Not Acceptance Biologic FDI and of USPHS comparison; Applied to G1G2; G3G4 and G5G6 separately.|Chi-squared|||H0: FDI or USPHS criteria Biological outcomes not differ at 24th month follow-up regarding Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) adhesive, with SE or SE-ER/ER modes.||||0.998
70856365|NCT00545129|141199463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.5||0.794|TWO_SIDED|95.0|-1.16|0.9|||ANCOVA|||Change at Week 6 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.90|-1.16|0.794
71122634|NCT02698371|141750832|EQUIVALENCE|alpha value of 0.05 was considered||||||0.029||||||Applied for all rows/Categories (graded on a 5-point scale) Surface Luster-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Surface Luster Performance at 24 Month Follow-up recall.||||0.029
71122635|NCT02698371|141750832|EQUIVALENCE|alpha value of 0.05 was considered||||||0.002||||||Applied for all rows/Categories (graded on a 5-point scale) Surface Luster-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Surface Luster performance at 24 Month Follow-up recall;||||0.002
71122636|NCT02698371|141750832|EQUIVALENCE|alpha value of 0.05 was considered||||||0.618||||||Applied for all rows/Categories (graded on a 5-point scale) Surface Luster-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Surface Luster performance at 24 Month Follow-up recall.||||0.618
71122637|NCT02698371|141750833|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.009||||||Applied for all rows/Categories (graded on a 5-point scale) Staining Margin-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Staining Margin Performance at 24 Month Follow-up recall.||||0.009
71122638|NCT02698371|141750833|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.059||||||Applied for all rows/Categories (graded on a 5-point scale) Staining Margin-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Staining Margin Performance at 24 Month Follow-up recall.||||0.059
71122639|NCT02698371|141750833|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.829||||||Applied for all rows/Categories (graded on a 5-point scale) Staining Margin-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Staining Margin performance at 24 month follow-up recall.||||0.829
71122640|NCT02698371|141750834|EQUIVALENCE|An alpha value of 0.05 was considered|||||<|0.001||||||Applied for all rows/Categories (graded on a 5-point scale) Colour Stability-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Colour Stability performance at 24 month follow-up recall.||||<0.001
71122641|NCT02698371|141750834|EQUIVALENCE|An alpha value of 0.05 was considered|||||<|0.001||||||Applied for all rows/Categories (graded on a 5-point scale) of Colour Stability-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Colour Stability performance at 24 month follow-up recall.||||<0.001
71084541|NCT00121719|141675027|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0146|||||||Wilcoxon signed-rank test|||This was a pilot study and a statistical sample size calculation was not performed.||||0.0146
71084542|NCT00382785|141675046|SUPERIORITY_OR_OTHER|||||||0.315|TWO_SIDED|95.0|||||univariate analysis|||Power calculation indicated that 60 subjects would be needed. Null Hypothesis: There will be no difference in perceived social support based on type of online support group (moderated or peer-led).||||.315
71084543|NCT00382785|141675047|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||univariate analysis|Null Hypothesis: There will be no difference between the moderated and peer-led groups based on type of online support (moderated; peer-led)||Power analysis indicated that 60 subjects were needed. Null hypothesis: There will be no difference in depressive symptoms based on type of online support group (moderated or peer-led).||||.23
71084544|NCT00382785|141675048|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED|95.0|||||Univariate Analysis|||Power analysis indicated that 60 subjects were needed. Null hypothesis: There will be no difference in quality of life (QOL) based on type of online support group (moderated or peer-led).||||.32
71084545|NCT01705977|141675059|OTHER||Difference in percentage versus placebo|0.1|||||TWO_SIDED|95.0|-0.31|0.51|||||95% Confidence Interval was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.51|-0.31|
71084546|NCT01705977|141675060|OTHER||Difference in percentage versus placebo|-0.35|||||TWO_SIDED|95.0|-1.55|0.85|||||95% CI for serious infections was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.85|-1.55|
71084547|NCT01705977|141675060|OTHER||Difference in percentage versus placebo|-0.7|||||TWO_SIDED|95.0|-1.6|0.2|||||95% CI for opportunistic infections and other infections of interest (serious and non-serious) was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.20|-1.60|
71084548|NCT01705977|141675060|OTHER||Difference in percentage versus placebo|0.0|||||TWO_SIDED|95.0|-0.31|0.31|||||95% CI for malignancies (excluding NMSC) was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.31|-0.31|
71084549|NCT01705977|141675060|OTHER||Difference in percentage versus placebo|0.05|||||TWO_SIDED|95.0|-0.21|0.31|||||95% CI for NMSC was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.31|-0.21|
71084550|NCT01705977|141675060|OTHER||Difference in percentage versus placebo|0.3|||||TWO_SIDED|95.0|0.02|0.58|||||95% CI for psychiatric events suggesting serious mood disorders and anxiety (serious depression) was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.58|0.02|
71084551|NCT01705977|141675060|OTHER||Difference in percentage versus placebo|0.26|||||TWO_SIDED|95.0|-0.44|0.96|||||95% CI for suicidality (C-SSRS) was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.96|-0.44|
71084552|NCT01705977|141675060|OTHER||Difference in percentage versus placebo|0.3|||||TWO_SIDED|95.0|-0.01|0.61|||||95% CI for SIHR was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.61|-0.01|
71084553|NCT01705977|141675062|OTHER||Difference in percentage versus placebo|-0.45|||||TWO_SIDED|95.0|-1.03|0.13|||||95% CI was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.13|-1.03|
71084554|NCT01705977|141675063|OTHER||Difference in percentage versus placebo|-0.75|||||TWO_SIDED|95.0|-2.02|0.51|||||95% CI for serious infections was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.51|-2.02|
71084555|NCT01705977|141675063|OTHER||Difference in percentage versus placebo|-1.0|||||TWO_SIDED|95.0|-1.96|-0.04|||||95% CI for opportunistic infections and other infections of interest (serious and non-serious) was calculated using simple asymptotic Chi-Square (Pearson) method.|||-0.04|-1.96|
71084556|NCT01705977|141675063|OTHER||Difference in percentage versus placebo|-0.1|||||TWO_SIDED|95.0|-0.44|0.24|||||95% CI for malignancies (excluding NMSC) was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.24|-0.44|
71084557|NCT01705977|141675063|OTHER||Difference in percentage versus placebo|0.05|||||TWO_SIDED|95.0|-0.21|0.31|||||95% CI for NMSC was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.31|-0.21|
71084558|NCT01705977|141675063|OTHER||Difference in percentage versus placebo|0.3|||||TWO_SIDED|95.0|0.02|0.58|||||95% CI for psychiatric events suggesting serious mood disorders and anxiety (serious depression) was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.58|0.02|
71084559|NCT01705977|141675063|OTHER||Difference in percentage versus placebo|0.31|||||TWO_SIDED|95.0|-0.42|1.05|||||95% CI for suicidality (C-SSRS) was calculated using simple asymptotic Chi-Square (Pearson) method.|||1.05|-0.42|
71084560|NCT01705977|141675063|OTHER||Difference in percentage versus placebo|0.3|||||TWO_SIDED|95.0|-0.01|0.61|||||95% CI for SIHR was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.61|-0.01|
71084561|NCT01705977|141675065|OTHER||Odds ratio versus placebo|1.3||||0.0284|TWO_SIDED|95.0|1.03|1.65|||Regression, Logistic||95% CI and P-value was calculated from a logistic regression model for the comparison between belimumab and placebo including treatment group, Baseline prednisone dose, screening SELENA SLEDAI score (\<=9 versus \>=10) and region|||1.65|1.03|0.0284
71084562|NCT00808067|141675120|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.0055|TWO_SIDED|95.0|0.64|0.93|||Regression, Cox|||||0.93|0.64|0.0055
71084563|NCT00808067|141675127|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.5119|TWO_SIDED|95.0|0.84|1.42|||Regression, Cox|||||1.42|0.84|0.5119
71084564|NCT00808067|141675128|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.2371|TWO_SIDED|95.0|0.94|1.29|||Regression, Cox|||||1.29|0.94|0.2371
71084565|NCT00808067|141675129|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.5052|TWO_SIDED|95.0|0.89|1.27|||Regression, Cox|||||1.27|0.89|0.5052
71084566|NCT00808067|141675130|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.2241||95.0|0.82|1.05|||Regression, Cox|||||1.05|0.82|0.2241
71084567|NCT03877224|141675176|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|3.16||||0.07905|TWO_SIDED|95.0|0.36|6.01||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate.|Rank ANCOVA|The model includes rank-based baseline, weeks impacted by COVID-19 and treatment group as covariates and is stratified by T2DM status at randomization||For the primary efficacy endpoint KCCQ-TSS, the following hypothesis was tested using the significance level 0.04990 • H0: m(r(A)) = m(r(C)) versus • H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in the primary efficacy endpoint, KCCQ-TSS, from baseline to week 16, among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively.||6.01|0.36|0.07905
71084568|NCT03877224|141675177|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|3.12||||0.23215|TWO_SIDED|95.0|-0.09|5.37||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate.|Rank ANCOVA|The model includes rank-based baseline, weeks impacted by COVID-19 and treatment group as covariates and is stratified by T2DM status at randomization||For the primary efficacy endpoint KCCQ-PLS, the following hypothesis was tested at significant level of 0.00005 • H0: m(r(A)) = m(r(C)) versus • H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in the primary efficacy endpoint, KCCQ-PLS, from baseline to week 16, among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively.||5.37|-0.09|0.23215
71084569|NCT03877224|141675178|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|1.6||||0.66801|TWO_SIDED|95.0|-5.9|9.0||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate.|Rank ANCOVA|The model includes rank-based baseline, treatment group as covariates and is stratified by T2DM status at randomization||For the primary efficacy endpoint 6MWD, the following hypothesis was tested using the significance level 0.00005: H0: m(r(A)) = m(r(C)) versus H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in the primary efficacy endpoint, 6MWD, from baseline to week 16, among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively.||9.0|-5.9|0.66801
71084570|NCT03877224|141675179|SUPERIORITY|Total time spent in LVPA was not tested for statistical significance and the p-value is considered nominal because the test for 6MWD was not statistically significant.|Hodges-Lehmann median diff. vs placebo|0.19||||0.12523|TWO_SIDED|95.0|-0.06|0.48|||Rank ANCOVA|Model includes baseline rank of outcome variable as a covariate, treatment group as a factor, and is stratified by T2DM status at randomization.||For the secondary efficacy endpoint, total time spent in LVPA, the testing hypothesis is • H0: m(r(A)) = m(r(C)) versus • H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in secondary efficacy endpoint, total time spent in LVPA, from baseline to End of study among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively.||0.48|-0.06|0.12523
70856366|NCT00545129|141199463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.56||0.772|TWO_SIDED|95.0|-1.33|1.0|||ANCOVA|||Change at Week 8 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.00|-1.33|0.772
70944578|NCT01723514|141389420|SUPERIORITY||LS Geometric Mean Ratio|-71.88|||<|0.001|TWO_SIDED|95.0|-83.93|-50.82|||Repeated Measures ANCOVA|||Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-50.82|-83.93|< 0.001
70944579|NCT01723514|141389420|SUPERIORITY||LS Geometric Mean Ratio|-68.51|||<|0.001|TWO_SIDED|95.0|-81.01|-47.78|||Repeated Measures ANCOVA|||Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-47.78|-81.01|< 0.001
70944580|NCT01723514|141389420|SUPERIORITY||LS Geometric Mean Ratio|-81.06|||<|0.001|TWO_SIDED|95.0|-88.62|-68.49|||Repeated Measures ANCOVA|||Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-68.49|-88.62|< 0.001
71084571|NCT04754542|141675198|NON_INFERIORITY|We performed a non-inferiority test for the proportions of the drug continuation and drug discontinuation arms experiencing a new MS relapse and/or MRI Brain Lesion over the course of the study duration. The non-inferiority margin used was 8%.|Difference in proportion|0.0121||||0.124|TWO_SIDED|95.0|-0.1321|0.1287|||Exact binomial test|Exact binomial test fr difference in two proportions||We tested the null hypothesis of inferiority with the proportion of disease events (i.e., new MS relapse and/or MRI brain lesion) for the drug discontinuation group being 8% greater than the proportion for the drug continuation group under the alternative that the two rates are equal.||0.1287|-0.1321|0.124
71084572|NCT04754542|141675199|SUPERIORITY|||||||0.639|||||||t-test, 2 sided|||||||0.639
71084573|NCT04754542|141675200|SUPERIORITY|||||||0.964|||||||t-test, 2 sided|||||||0.964
71084574|NCT04754542|141675201|SUPERIORITY|||||||0.819|||||||t-test, 2 sided|||||||0.819
71084575|NCT04754542|141675202|SUPERIORITY|||||||0.515|||||||t-test, 2 sided|||||||0.515
71084576|NCT04754542|141675203|SUPERIORITY|||||||0.388|||||||t-test, 2 sided|||||||0.388
71084577|NCT04754542|141675204|SUPERIORITY|||||||0.183|||||||t-test, 2 sided|||||||0.183
71084578|NCT04754542|141675205|SUPERIORITY|||||||0.414|||||||t-test, 2 sided|||||||0.414
71084579|NCT04754542|141675206|SUPERIORITY|||||||0.998|||||||t-test, 2 sided|||||||0.998
71084580|NCT04754542|141675207|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||||||0.320
71084581|NCT04754542|141675208|SUPERIORITY|||||||0.061|||||||t-test, 2 sided|||||||0.061
71084582|NCT04754542|141675209|SUPERIORITY|||||||0.032|||||||t-test, 2 sided|||||||0.032
71084583|NCT04754542|141675210|SUPERIORITY|||||||0.514|||||||t-test, 2 sided|||||||0.514
71084584|NCT04754542|141675211|SUPERIORITY|||||||0.017|||||||t-test, 2 sided|||||||0.017
71084585|NCT04754542|141675212|SUPERIORITY|||||||0.155|||||||t-test, 2 sided|||||||0.155
71084586|NCT04754542|141675213|SUPERIORITY|||||||0.358|||||||t-test, 2 sided|||||||0.358
71084587|NCT04754542|141675214|SUPERIORITY|||||||0.151|||||||t-test, 2 sided|||||||0.151
71084588|NCT04754542|141675215|SUPERIORITY|||||||0.123|||||||t-test, 2 sided|||||||0.123
71084589|NCT04754542|141675216|SUPERIORITY|||||||0.656|||||||Chi-squared|||||||0.656
71084590|NCT04754542|141675217|SUPERIORITY|||||||0.892|||||||Chi-squared|||||||0.892
71084591|NCT04754542|141675218|SUPERIORITY|||||||0.063|||||||Mantel Haenszel|Cochran-Mantel-Haenszel chi-square test for ordinal-nominal association was used||||||0.063
71084592|NCT02359110|141675231|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.89|TWO_SIDED|95.0|-1.2|1.3|||Mixed Models Analysis|||Hour 2 Analysis||1.3|-1.2|0.89
71084593|NCT02359110|141675231|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.94|TWO_SIDED|95.0|-1.6|1.5|||Mixed Models Analysis|||Hour 4 Analysis||1.5|-1.6|0.94
71084594|NCT02359110|141675231|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.64|TWO_SIDED|95.0|-2.2|1.3|||Mixed Models Analysis|||Hour 6 Analysis||1.3|-2.2|0.64
71084595|NCT02359110|141675231|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.59|TWO_SIDED|95.0|-1.6|2.8|||Mixed Models Analysis|||Hour 8 Analysis||2.8|-1.6|0.59
71084596|NCT02359110|141675232|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.52|TWO_SIDED|95.0|-8.1|15.8|||Mixed Models Analysis|||Hour 2 Analysis||15.8|-8.1|0.52
71084597|NCT02359110|141675232|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.8|TWO_SIDED|95.0|-11.9|15.3|||Mixed Models Analysis|||Hour 6 Analysis||15.3|-11.9|0.80
71084598|NCT02359110|141675233|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||||||0.88
71084599|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.5221||||||The reported p-value is representative of the changes in levels of all CD4 cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.5221
71084600|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.25||||||The reported p-value is representative of the changes in levels of CD4 cells at dose level 1.|Wilcoxon test|||||||0.25
71084601|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.5||||||The reported p-value is representative of the changes in levels of CD4 cells at dose level 3.|Wilcoxon test|||||||0.50
71084602|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.16||||||The reported p-value is representative of the changes in levels of CD4 cells at dose level 4.|Wilcoxon test|||||||0.16
71084603|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.8665||||||The reported p-value is representative of the changes in levels of all CD8 cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.8665
71084604|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.88||||||The reported p-value is representative of the changes in levels of all CD8 cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.88
71084605|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.84||||||The reported p-value is representative of the changes in levels of CD8 cells at dose level 3.|Wilcoxon test|||||||0.84
71084606|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.57||||||The reported p-value is representative of the changes in levels of CD8 cells at dose level 4.|Wilcoxon test|||||||0.57
71084607|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.3052||||||The reported p-value is representative of the changes in levels of all B cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.3052
71084608|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of B cells at dose level 1.|Wilcoxon test|The reported p-value is representative of the changes in levels of B cells at dose level 1.||||||>0.9999
71084609|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.13||||||The reported p-value is representative of the changes in levels of B cells at dose level 3.|Wilcoxon test|||||||0.13
71084610|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.65||||||The reported p-value is representative of the changes in levels of B cells at dose level 4.|Wilcoxon test|||||||0.65
71084611|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0698||||||The reported p-value is representative of the changes in levels of all NK cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.0698
71084612|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.63||||||The reported p-value is representative of the changes in levels of NK cells at dose level 1.|Wilcoxon test|||||||0.63
71084613|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.74||||||The reported p-value is representative of the changes in levels of NK cells at dose level 3.|Wilcoxon test|||||||0.74
70856367|NCT00545129|141199463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.5||0.547|TWO_SIDED|95.0|-0.73|1.34|||ANCOVA|||Change at Week 1 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.34|-0.73|0.547
70856368|NCT00545129|141199463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.57||0.65|TWO_SIDED|95.0|-1.43|0.91|||ANCOVA|||Change at Week 2 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.91|-1.43|0.650
70856369|NCT00545129|141199463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.55||0.808|TWO_SIDED|95.0|-1.27|1.0|||ANCOVA|||Change at Week 4 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.00|-1.27|0.808
70856370|NCT00545129|141199463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.55||0.915|TWO_SIDED|95.0|-1.19|1.07|||ANCOVA|||Change at Week 6 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.07|-1.19|0.915
70856371|NCT00545129|141199463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.65||0.757|TWO_SIDED|95.0|-1.54|1.14|||ANCOVA|||Change at Week 8 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.14|-1.54|0.757
70856372|NCT00545129|141199463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.57||0.987|TWO_SIDED|95.0|-1.19|1.17|||ANCOVA|||Change at Week 1 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.17|-1.19|0.987
70856373|NCT00545129|141199463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.64||0.781|TWO_SIDED|95.0|-1.14|1.51|||ANCOVA|||Change at Week 2 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.51|-1.14|0.781
71122642|NCT02698371|141750834|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.064||||||Applied for all rows/Categories (graded on a 5-point scale) of Colour Stability-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Colour Stability performance at 24 month follow-up recall.||||0.064
71122643|NCT02698371|141750835|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.006||||||Applied for all rows/Categories (graded on a 5-point scale) of Fractures and Retention-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Fractures and Retention performance at 24 month follow-up recall.||||0.006
71122644|NCT02698371|141750835|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.02||||||Applied for all rows/Categories (graded on a 5-point scale) of Fractures and Retention-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Fractures and Retention performance at 24 month follow-up recall.||||0.020
71084614|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.13||||||The reported p-value is representative of the changes in levels of NK cells at dose level 4.|Wilcoxon test|||||||0.13
71084615|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0127||||||The reported p-value is representative of the changes in levels of all NKT cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.0127
71084616|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.63||||||The reported p-value is representative of the changes in levels of NKT cells at dose level 1.|Wilcoxon test|||||||0.63
71084617|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.41||||||The reported p-value is representative of the changes in levels of NKT cells at dose level 3.|Wilcoxon test|||||||0.41
71084618|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.07||||||The reported p-value is representative of the changes in levels of NKT cells at dose level 4.|Wilcoxon test|||||||0.07
71084619|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0654||||||The reported p-value is representative of the changes in levels of all cDC cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.0654
71084620|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.38||||||The reported p-value is representative of the changes in levels of cDC cells at dose level 1.|Wilcoxon test|||||||0.38
71084621|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.21||||||The reported p-value is representative of the changes in levels of cDC cells at dose level 3.|Wilcoxon test|||||||0.21
71084622|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.16||||||The reported p-value is representative of the changes in levels of cDC cells at dose level 4.|Wilcoxon test|||||||0.16
71084623|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0457||||||The reported p-value is representative of the changes in levels of all pDC cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.0457
71084624|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.63||||||The reported p-value is representative of the changes in levels of pDC cells at dose level 1.|Wilcoxon test|||||||0.63
71084625|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.55||||||The reported p-value is representative of the changes in levels of pDC cells at dose level 3.|Wilcoxon test|||||||0.55
71084626|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.13||||||The reported p-value is representative of the changes in levels of pDC cells at dose level 4.|Wilcoxon test|||||||0.13
71084627|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.7114||||||The reported p-value is representative of the changes in levels of all MDSC cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.7114
71084628|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of MDSC cells at dose level 1.|Wilcoxon test|||||||>0.9999
71084629|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.38||||||The reported p-value is representative of the changes in levels of MDSC cells at dose level 3.|Wilcoxon test|||||||0.38
71084630|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.91||||||The reported p-value is representative of the changes in levels of MDSC cells at dose level 4.|Wilcoxon test|||||||0.91
70944581|NCT01723514|141389420|SUPERIORITY||LS Geometric Mean Ratio|-79.04|||<|0.001|TWO_SIDED|95.0|-88.02|-63.34|||Repeated Measures ANCOVA|||Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-63.34|-88.02|< 0.001
70944582|NCT01723514|141389420|SUPERIORITY||LS Geometric Mean Ratio|-32.7||||0.25|TWO_SIDED|95.0|-65.71|32.1|||Repeated Measures ANCOVA|||Day 113: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||32.10|-65.71|0.25
70944583|NCT01723514|141389420|SUPERIORITY||LS Geometric Mean Ratio|3.44||||0.9|TWO_SIDED|95.0|-40.78|80.66|||Repeated Measures ANCOVA|||Day 169: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||80.66|-40.78|0.90
70944584|NCT01723514|141389420|SUPERIORITY||LS Geometric Mean Ratio|-40.53||||0.091|TWO_SIDED|95.0|-67.5|8.82|||Repeated Measures ANCOVA|||Day 169: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||8.82|-67.50|0.091
70944585|NCT01723514|141389420|SUPERIORITY||LS Geometric Mean Ratio|13.33||||0.73|TWO_SIDED|95.0|-44.39|130.94|||Repeated Measures ANCOVA|||Day 197: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||130.94|-44.39|0.73
70944586|NCT01723514|141389420|SUPERIORITY||LS Geometric Mean Ratio|-80.02||||0.001|TWO_SIDED|95.0|-91.53|-52.87|||Repeated Measures ANCOVA|||Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-52.87|-91.53|0.001
70944587|NCT01723514|141389420|SUPERIORITY||LS Geometric Mean Ratio|-87.6|||<|0.001|TWO_SIDED|95.0|-94.53|-71.88|||Repeated Measures ANCOVA|||Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-71.88|-94.53|< 0.001
71084631|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.2666||||||The reported p-value is representative of the changes in levels of all Treg cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.2666
71084632|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.88||||||The reported p-value is representative of the changes in levels of Treg cells at dose level 1.|Wilcoxon test|||||||0.88
71084633|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.45||||||The reported p-value is representative of the changes in levels of Treg cells at dose level 1.|Wilcoxon test|||||||0.45
71084634|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.36||||||The reported p-value is representative of the changes in levels of Treg cells at dose level 4.|Wilcoxon test|||||||0.36
71084635|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0076||||||The reported p-value is representative of the changes in levels of all CD4 EM cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.0076
71084636|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.38||||||The reported p-value is representative of the changes in levels of CD4 EM cells at dose level 1.|Wilcoxon test|||||||0.38
71084637|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.22||||||The reported p-value is representative of the changes in levels of CD4 EM cells at dose level 3.|Wilcoxon test|||||||0.22
71122645|NCT02698371|141750835|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.054||||||Applied for all rows/Categories (graded on a 5-point scale) of Fractures and Retention-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Fractures and Retention performance at 24 month follow-up recall.||||0.054
71122646|NCT02698371|141750836|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.01||||||Applied for all rows/Categories (graded on a 5-point scale) of Marginal Adaptation-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Marginal Adaptation performance at 24 month follow-up recall.||||0.010
70944588|NCT01723514|141389420|SUPERIORITY||LS Geometric Mean Rratio|-79.81||||0.001|TWO_SIDED|95.0|-91.44|-52.37|||Repeated Measures ANCOVA|||Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-52.37|-91.44|0.001
70944589|NCT01723514|141389420|SUPERIORITY||LS Geometric Mean Ratio|-83.66|||<|0.001|TWO_SIDED|95.0|-92.79|-62.95|||Repeated Measures ANCOVA|||Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-62.95|-92.79|< 0.001
70944590|NCT01723514|141389420|SUPERIORITY||LS Geometric Mean Ratio|-81.97|||<|0.001|TWO_SIDED|95.0|-92.35|-57.46|||Repeated Measures ANCOVA|||Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-57.46|-92.35|< 0.001
70944591|NCT01723514|141389420|SUPERIORITY||LS Geometric Mean Ratio|-84.39|||<|0.001|TWO_SIDED|95.0|-93.12|-64.6|||Repeated Measures ANCOVA|||Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-64.60|-93.12|< 0.001
71122647|NCT02698371|141750836|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.071||||||Applied for all rows/Categories (graded on a 5-point scale) of Marginal Adaptation-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Marginal Adaptation performance at 24 month follow-up recall.||||0.071
71122648|NCT02698371|141750836|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.898||||||Applied for all rows/Categories (graded on a 5-point scale) of Marginal Adaptation-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Marginal Adaptation performance at 24 month follow-up recall.||||0.898
71122649|NCT02698371|141750837|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.317||||||Applied for all rows/Categories (graded on a 5-point scale) of Postoperative Hypersensibility, Tooth Vitality-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Postoperative Hypersensibility, Tooth Vitality performance at 24 month follow-up recall.||||0.317
71122650|NCT02698371|141750837|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.18||||||Applied for all rows/Categories (graded on a 5-point scale) of Postoperative Hypersensibility, Tooth Vitality-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Postoperative Hypersensibility, Tooth Vitality performance at 24 month follow-up recall.||||0.180
70944592|NCT01723514|141389420|SUPERIORITY||LS Geometric Mean Ratio|43.1||||0.47|TWO_SIDED|95.0|-47.06|286.83|||Repeated Measures ANCOVA|||Day 113: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||286.83|-47.06|0.47
71084638|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.1||||||The reported p-value is representative of the changes in levels of CD4 EM cells at dose level 4.|Wilcoxon test|||||||0.10
71084639|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.7144||||||The reported p-value is representative of the changes in levels of all CD4 CM cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.7144
71084640|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.13||||||The reported p-value is representative of the changes in levels of CD4 CM cells at dose level 1.|Wilcoxon test|||||||0.13
71084641|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.06||||||The reported p-value is representative of the changes in levels of CD4 CM cells at dose level 3.|Wilcoxon test|||||||0.06
71084642|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.13||||||The reported p-value is representative of the changes in levels of CD4 CM cells at dose level 4.|Wilcoxon test|||||||0.13
71084643|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.3741||||||The reported p-value is representative of the changes in levels of all CD4 EMRA cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.3741
71084644|NCT01519817|141675244|NON_INFERIORITY|The reported p-value is representative of the changes in levels of CD4 EMRA cells at dose level 1.||||||0.63|||||||Wilcoxon test|||||||0.63
71084645|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.13||||||The reported p-value is representative of the changes in levels of CD4 EMRA cells at dose level 3.|Wilcoxon test|||||||0.13
71084646|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of CD4 EMRA cells at dose level 4.|Wilcoxon test|||||||>0.9999
71084647|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.3386||||||The reported p-value is representative of the changes in levels of all CD4 naive cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.3386
71084648|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.88||||||The reported p-value is representative of the changes in levels of CD4 naive cells at dose level 1.|Wilcoxon test|||||||0.88
71084649|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0215||||||The reported p-value is representative of the changes in levels of CD4 naive cells at dose level 3.|Wilcoxon test|||||||0.0215
71084650|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.65||||||The reported p-value is representative of the changes in levels of CD4 naive cells at dose level 4.|Wilcoxon test|||||||0.65
71084651|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.5076||||||The reported p-value is representative of the changes in levels of all CD8 EM cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.5076
71084652|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.63||||||The reported p-value is representative of the changes in levels of CD8 EM cells at dose level 1.|Wilcoxon test|||||||0.63
71084653|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.68||||||The reported p-value is representative of the changes in levels of CD8 EM cells at dose level 3.|Wilcoxon test|||||||0.68
71084654|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.73||||||The reported p-value is representative of the changes in levels of CD8 EM cells at dose level 4.|Wilcoxon test|||||||0.73
71084655|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.6577||||||The reported p-value is representative of the changes in levels of all CD8 CM cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.6577
71084656|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.88||||||The reported p-value is representative of the changes in levels of CD8 CM cells at dose level 1.|Wilcoxon test|||||||0.88
71084657|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.74||||||The reported p-value is representative of the changes in levels of CD8 CM cells at dose level 3.|Wilcoxon test|||||||0.74
71084658|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.2||||||The reported p-value is representative of the changes in levels of CD8 CM cells at dose level 4.|Wilcoxon test|||||||0.20
71084659|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.6295||||||The reported p-value is representative of the changes in levels of all CD8 EMRA cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.6295
71122651|NCT02698371|141750837|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.918||||||Applied for all rows/Categories (graded on a 5-point scale) of Postoperative Hypersensibility, Tooth Vitality-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Postoperative Hypersensibility, Tooth Vitality performance at 24 month follow-up recall.||||0.918
71122652|NCT02698371|141750838|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.317||||||Applied for all rows/Categories (graded on a 5-point scale) of Recurrence of Caries, Erosion, Abfraction-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Recurrence of Caries, Erosion, Abfraction performance at 24 month follow-up recall.||||0.317
70856374|NCT00545129|141199463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.61||0.834|TWO_SIDED|95.0|-1.13|1.38|||ANCOVA|||Change at Week 4 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.38|-1.13|0.834
71084660|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.63||||||The reported p-value is representative of the changes in levels of CD8 EMRA cells at dose level 1.|Wilcoxon test|||||||0.63
71084661|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.999||||||The reported p-value is representative of the changes in levels of CD8 EMRA cells at dose level 3.|Wilcoxon test|||||||>0.999
71084662|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.36||||||The reported p-value is representative of the changes in levels of CD8 EMRA cells at dose level 4.|Wilcoxon test|||||||0.36
71084663|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.8314||||||The reported p-value is representative of the changes in levels of all CD8 naive cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.8314
71084664|NCT01519817|141675244|NON_INFERIORITY|The reported p-value is representative of the changes in levels of CD8 naive cells at dose level 1.||||||0.63|||||||Wilcoxon test|||||||0.63
71084665|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.64||||||The reported p-value is representative of the changes in levels of CD8 naive cells at dose level 3.|Wilcoxon test|||||||0.64
71084666|NCT01519817|141675244|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.3||||||The reported p-value is representative of the changes in levels of CD8 naive cells at dose level 4.|Wilcoxon test|||||||0.30
71084667|NCT01519817|141675245|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.375||||||The reported p-value is representative of the changes in levels of IFNg cytokines at dose level 1.|Wilcoxon test|||||||0.375
71084668|NCT01519817|141675245|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.4808||||||The reported p-value is representative of the changes in levels of all IFNg cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.4808
71084669|NCT01519817|141675245|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.7334||||||The reported p-value is representative of the changes in levels of IFNg cytokines at dose level 3.|Wilcoxon test|||||||0.7334
71084670|NCT01519817|141675245|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.7109||||||The reported p-value is representative of the changes in levels of IFNg cytokines at dose level 4.|Wilcoxon|||||||0.7109
71084671|NCT01519817|141675245|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.4347||||||The reported p-value is representative of the changes in levels of all IL10 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.4347
71084672|NCT01519817|141675245|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL10 cytokines at dose level 1.|Wilcoxon|||||||>0.9999
71084673|NCT01519817|141675245|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.748||||||The reported p-value is representative of the changes in levels of IL10 cytokines at dose level 3.|Wilcoxon test|||||||0.748
71084674|NCT01519817|141675245|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.8203|||||||Wilcoxon test|The reported p-value is representative of the changes in levels of IL10 cytokines at dose level 4.||||||0.8203
71084675|NCT01519817|141675245|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.5625||||||The reported p-value is representative of the changes in levels of all IL12p70 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.5625
71084676|NCT01519817|141675245|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL12p70 cytokines at dose level 1.|Wilcoxon test|||||||>0.9999
71084677|NCT01519817|141675245|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL12p70 cytokines at dose level 3.|Wilcoxon test|||||||>0.9999
71084678|NCT01519817|141675245|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.5||||||The reported p-value is representative of the changes in levels of IL12p70 cytokines at dose level 14|Wilcoxon test|||||||0.5
71084679|NCT01519817|141675245|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.6846||||||The reported p-value is representative of the changes in levels of all IL1b cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.6846
71084680|NCT01519817|141675245|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL1b cytokines at dose level 1.|Wilcoxon test|||||||>0.9999
71084681|NCT01519817|141675245|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.5||||||The reported p-value is representative of the changes in levels of IL1b cytokines at dose level 3.|Wilcoxon test|||||||0.5
71084682|NCT01519817|141675245|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL1b cytokines at dose level 4.|Wilcoxon test|||||||>0.9999
71084683|NCT01519817|141675245|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.4375||||||The reported p-value is representative of the changes in levels of all IL-2 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.4375
71084684|NCT01519817|141675245|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL-2 cytokines at dose level 1.|Wilcoxon test|||||||>0.9999
71084685|NCT01519817|141675245|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL-2 cytokines at dose level 3.|Wilcoxon test|||||||>0.9999
71084686|NCT01519817|141675245|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.75||||||The reported p-value is representative of the changes in levels of IL-2 cytokines at dose level 4.|Wilcoxon test|||||||0.75
71084687|NCT01519817|141675245|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.4525||||||The reported p-value is representative of the changes in levels of all IL-6 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|The reported p-value is representative of the changes in levels of IL-6 cytokines at dose level 1.||||||0.4525
71084688|NCT01519817|141675245|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.875||||||The reported p-value is representative of the changes in levels of IL-6 cytokines at dose level 1.|Wilcoxon test|||||||0.875
71084689|NCT01519817|141675245|NON_INFERIORITY|The reported p-value is representative of the changes in levels of IL-6 cytokines at dose level 3.||||||0.4316|||||||Wilcoxon test|||Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||0.4316
71084690|NCT01519817|141675245|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL-6 cytokines at dose level 4.|Wilcoxon test|||||||>0.9999
71084691|NCT01519817|141675245|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.9906||||||The reported p-value is representative of the changes in levels of all IL-8 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.9906
71084692|NCT01519817|141675245|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.625|||||||Wilcoxon test|The reported p-value is representative of the changes in levels of IL-8 cytokines at dose level 1.||||||0.625
71084693|NCT01519817|141675245|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.791||||||The reported p-value is representative of the changes in levels of IL-8 cytokines at dose level 3.|Wilcoxon test|||||||0.791
71084694|NCT01519817|141675245|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.8203||||||The reported p-value is representative of the changes in levels of IL-8 cytokines at dose level 4.|Wilcoxon test|||||||0.8203
71084695|NCT01519817|141675245|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of all TNF cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||>0.9999
71084696|NCT01519817|141675245|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.875||||||The reported p-value is representative of the changes in levels of TNF cytokines at dose level 1.|Wilcoxon test|||||||0.875
71084697|NCT01519817|141675245|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.9658||||||The reported p-value is representative of the changes in levels of TNF cytokines at dose level 3.|Wilcoxon test|||||||0.9658
71084698|NCT01519817|141675245|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.6523||||||The reported p-value is representative of the changes in levels of TNF cytokines at dose level 4.|Wilcoxon test|||||||0.6523
71084699|NCT01519817|141675246|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.2901||||||The reported p-value is representative of the changes in levels of all sCD27 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.2901
71084700|NCT01519817|141675246|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.375||||||The reported p-value is representative of the changes in levels of sCD27 cytokines at dose level 1.|Wilcoxon test|||||||0.375
70856375|NCT00545129|141199463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.59||0.851|TWO_SIDED|95.0|-1.32|1.1|||ANCOVA|||Change at Week 6 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.10|-1.32|0.851
71084701|NCT01519817|141675246|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.2036||||||The reported p-value is representative of the changes in levels of sCD27 cytokines at dose level 3.|Wilcoxon test|||||||0.2036
71084702|NCT01519817|141675246|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0742||||||The reported p-value is representative of the changes in levels of sCD27 cytokines at dose level 4.|Wilcoxon test|||||||0.0742
71084703|NCT01519817|141675247|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.1004||||||The reported p-value is representative of the changes in levels of all ratio sCD27:sCD40AL cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.1004
71084704|NCT01519817|141675247|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.625||||||The reported p-value is representative of the changes in levels of ratio sCD27:sCD40L cytokines at dose level 1.|Wilcoxon test|||||||0.625
71084705|NCT01519817|141675247|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.6772||||||The reported p-value is representative of the changes in levels of ratio sCD27:sCD40L cytokines at dose level 3.|Wilcoxon test|||||||0.6772
71084706|NCT01519817|141675247|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.3008||||||The reported p-value is representative of the changes in levels of ratio sCD27:sCD40L cytokines at dose level 4.|Wilcoxon test|||||||0.3008
71084707|NCT01519817|141675248|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0621||||||The reported p-value is representative of the changes in levels of all sCD40L cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.0621
71084708|NCT01519817|141675248|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.875||||||The reported p-value is representative of the changes in levels of sCD40L cytokines at dose level 1.|Wilcoxon test|||||||0.875
71122653|NCT02698371|141750838|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.317||||||Applied for all rows/Categories (graded on a 5-point scale) of Recurrence of Caries, Erosion, Abfraction-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Recurrence of Caries, Erosion, Abfraction performance at 24 month follow-up recall.||||.317
71122654|NCT02698371|141750838|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.575||||||Applied for all rows/Categories (graded on a 5-point scale) of Recurrence of Caries, Erosion \& Abfraction-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Recurrence of Caries, Erosion, Abfraction performance at 24 month follow-up recall.||||0.575
70944593|NCT01723514|141389420|SUPERIORITY||LS Geometric Mean Ratio|-68.58||||0.02|TWO_SIDED|95.0|-88.02|-17.63|||Repeated Measures ANCOVA|||Day 169: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-17.63|-88.02|0.020
71084709|NCT01519817|141675248|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.2402||||||The reported p-value is representative of the changes in levels of sCD40L cytokines at dose level 3.|Wilcoxon test|||||||0.2402
71084710|NCT01519817|141675248|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.3008||||||The reported p-value is representative of the changes in levels of sCD40L cytokines at dose level 4.|Wilcoxon test|||||||0.3008
71084711|NCT00737100|141675280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.94||||0.001||95.0|1.19|4.7||Comment for p-value: Hierarchical testing was applied. Comparison of 2.5 dose to be performed only if superiority of tiotropium 5.0 dose compared to placebo was shown for both primary endpoints.|Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||4.70|1.19|0.001
71084712|NCT00737100|141675280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.39||||0.0001||95.0|1.67|5.12||Comment for p-value: Hierarchical testing was applied. Comparison of 2.5 dose to be performed only if superiority of tiotropium 5.0 dose compared to placebo was shown for both primary endpoints.|Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||5.12|1.67|0.0001
71084713|NCT00737100|141675281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.24||||0.0184||95.0|0.38|4.11||Comment for p-value: Hierarchical testing was applied. Comparison of 2.5 dose to be performed only if superiority of tiotropium 5.0 dose compared to placebo was shown for both primary endpoints.|Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||4.11|0.38|0.0184
71084714|NCT00737100|141675281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22||||0.0179||95.0|0.38|4.06||Comment for p-value: Hierarchical testing was applied. Comparison of 2.5 dose to be performed only if superiority of tiotropium 5.0 dose compared to placebo was shown for both primary endpoints.|Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||4.06|0.38|0.0179
71084715|NCT00737100|141675282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.83||||0.0756||95.0|-0.19|3.86|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||3.86|-0.19|0.0756
71084716|NCT00737100|141675282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.12||||0.0023||95.0|1.12|5.12|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||5.12|1.12|0.0023
71122655|NCT02698371|141750839|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.02||||||Applied for all rows/Categories (graded on a 5-point scale) of Tooth Integrity (enamel cracks)-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Tooth Integrity (enamel cracks) performance at 24 month follow-up recall.||||0.020
71122656|NCT02698371|141750839|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.107||||||Applied for all rows/Categories (graded on a 5-point scale) of Tooth Integrity (enamel cracks)-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Tooth Integrity (enamel cracks) performance at 24 month follow-up recall.||||0.107
71122657|NCT02698371|141750839|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.592||||||Applied for all rows/Categories (graded on a 5-point scale) of Tooth Integrity (enamel cracks)-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Tooth Integrity (enamel cracks) performance at 24 month follow-up recall.||||0.592
71122658|NCT02698371|141750840|EQUIVALENCE|An alpha value of 0.05 was considered||||||1||||||Applied for rows/categories alfa/bravo/charlie of Surface Staining-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Surface Staining performance at 24 month follow-up recall.||||1.000
71122659|NCT02698371|141750840|EQUIVALENCE|An alpha value of 0.05 was considered||||||1||||||Applied for rows/categories alfa/bravo/charlie of Surface Staining-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Surface Staining performance at 24 month follow-up recall.||||1.000
71122660|NCT02698371|141750840|EQUIVALENCE|An alpha value of 0.05 was considered||||||1||||||Applied for rows/categories alfa/bravo/charlie of Surface Staining-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Surface Staining performance at 24 month follow-up recall.||||1.000
71084717|NCT00737100|141675283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.3857||95.0|-1.08|2.79|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||2.79|-1.08|0.3857
71084718|NCT00737100|141675283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.19||||0.2199||95.0|-0.72|3.11|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||3.11|-0.72|0.2199
71084719|NCT00737100|141675284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.19||||0.0363||95.0|0.27|8.11|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||8.11|0.27|0.0363
71084720|NCT00737100|141675284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.34||||0.0073||95.0|1.45|9.23|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||9.23|1.45|0.0073
71084721|NCT00737100|141675285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.7414||95.0|-0.06|0.08|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||0.08|-0.06|0.7414
71084722|NCT00737100|141675285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.1418||95.0|-0.02|0.12|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||0.12|-0.02|0.1418
71084723|NCT00737100|141675286|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.8515||95.0|0.37|1.72|||Regression, Logistic|Covariates of treatment and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||1.72|0.37|0.8515
71084724|NCT00737100|141675286|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.5565||95.0|0.33|1.59|||Regression, Logistic|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||1.59|0.33|0.5565
71084725|NCT00643201|141675305|NON_INFERIORITY_OR_EQUIVALENCE|Statistical Testing: non-inferiority tested at 1-sided α=0.025 with margin of 1.8. Demonstration of non-inferiority using both relative risk (RR) (margin = 1.8) and risk difference (RD) (margin = 0.035) were required to achieve the primary objective.|Risk Ratio (RR)|0.839|||<|0.0001|TWO_SIDED|95.0|0.5965|1.1802||This is the first test in a sequential testing sequence. p-value calculated based on the Yanagawa-Tango-Hiejima test stratified by index event strata for non-inferiority. Tested at 1-sided α=0.025|Yanagawa-Tango-Hiejima|For a successful trial; rejection of the null hypotheses for both RR and RD was required.||Hypothesis that apixaban was non-inferior to enoxaparin/warfarin therapy in preventing the recurrence of VTE (nonfatal DVT or nonfatal PE)/VTE-related death.||1.1802|0.5965|<0.0001
71084726|NCT00643201|141675305|NON_INFERIORITY_OR_EQUIVALENCE|Statistical Testing; non-inferiority tested at 1-sided α=0.025. If non-inferiority demonstrated for both RR and RD, the primary objective was achieved.|Risk Difference (RD)|-0.0044|||<|0.0001|TWO_SIDED|95.0|-0.0128|0.004||Yanagawa-Tango-Hiejima test statistic for risk difference (RD).|Yanagawa-Tango-Hiejima|||Hypothesis that apixaban was non-inferior to enoxaparin/warfarin therapy in preventing the recurrence of VTE (nonfatal DVT or nonfatalPE)/VTE-related death as measured by risk difference.||0.0040|-0.0128|<0.0001
70944594|NCT01723514|141389420|SUPERIORITY||LS Geometric Mean Ratio|-54.32||||0.11|TWO_SIDED|95.0|-82.58|19.75|||Repeated Measures ANCOVA|||Day 197: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||19.75|-82.58|0.11
70944595|NCT00014222|141389426|SUPERIORITY|||||||0.0007|||||||Log Rank|||||||0.0007
70944596|NCT00014222|141389427|SUPERIORITY|||||||0.084|||||||Log Rank|||||||0.084
70944597|NCT00519285|141389437|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.942||||0.3802|TWO_SIDED|95.6|0.822|1.08||A priori threshold for statistical significance was set to 0.044 using the O'Brien-Fleming alpha spending function to account for two interim analyses.|Log Rank|Log rank test stratified on ECOG Performance Status|Hazard ratio (HR) aflibercept versus placebo estimated from a Cox proportional hazard model stratified on ECOG Performance Status|"Null hypothesis: No difference between aflibercept and placebo~The study was designed to provide 90% power to detect a 1.25-fold increase in median survival with aflibercept compared to placebo at a overall one-sided significance level of 0.025 with 873 deaths."||1.08|0.822|0.3802
70944598|NCT02970305|141389480|SUPERIORITY||Difference in MMRM LSMs|-1.9|STANDARD_ERROR_OF_MEAN|0.95||0.0434|TWO_SIDED|95.0|-3.8|-0.1|||Mixed-effects model for repeated measure|||||-0.1|-3.8|0.0434
70944599|NCT00983892|141389493|SUPERIORITY_OR_OTHER||Slope|-1.56||||0.03|TWO_SIDED|95.0|-2.97|-0.15|||GEE|Adjusting for baseline symptom severity, caregiver type, week number, and cancer site.||||-0.15|-2.97|0.030
70944600|NCT00988117|141389545|SUPERIORITY_OR_OTHER||Tscore|5.19|||<|0.01||95.0||||t-tests were statistically thresholded using the joint probability distribution method to correct for multiple comparisons, p \< 0.01 for voxel height and p \< 0.05 for cluster extent|t-test, 2 sided|A mask included only those regions where the patients showed abnormally low fALFF at either timepoint relative to a sample of 15 age-matched controls.||"Each voxel's BOLD signal time series was detrended and transformed to the frequency domain. We divided the sum of the square roots across the 0.01-0.08 Hz range by that across the entire frequency range (0-0.25 Hz).~fALFF group comparisons were evaluated using t-tests corrected for multiple comparisons. To determine if there were treatment-associated changes in brain activity, we compared voxel-wise fALFF in the patients at baseline to post-treatment."||||<0.01
70944601|NCT00988117|141389546|SUPERIORITY_OR_OTHER||pearson's r correlation coefficient|-0.82|||<|0.01||95.0||||This p-value was not adjusted for multiple comparisons.|Regression, Linear|||correlation with left inferior frontal gyrus / premotor falff change||||<.01
70944602|NCT00988117|141389546|SUPERIORITY_OR_OTHER||pearson's correlation coefficient|-0.35||||0.36||95.0||||This p-value was not adjusted for multiple comparisons.|Regression, Linear|||correlation with left supplementary motor area falff change||||.36
70944603|NCT00988117|141389547|SUPERIORITY_OR_OTHER||pearson's r correlation|0.18||||0.58||95.0|||||Regression, Linear|||correlation with left premotor / inferior frontal gyri falff change||||.58
70944604|NCT00988117|141389547|SUPERIORITY_OR_OTHER||pearson's correlation coefficient|0.26||||0.41||95.0||||This p-value was not adjusted for multiple comparisons.|Regression, Linear|||correlation with left supplementary motor area falff change||||.41
70944605|NCT00702273|141389548|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin of -8%|Risk Difference (RD)|2.4|||||TWO_SIDED|95.0|-2.6|7.4||||||Treatment groups were compared with a generalized linear model including covariates treatment group, age class and region.||7.4|-2.6|
71084727|NCT00643201|141675305|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.839||||0.3128|TWO_SIDED|95.0|0.5965|1.1802||Tested at 2-sided α=0.05 significance. Further inferential statistical testing halted due to failure to reject the null hypothesis of equivalence for VTE/VTE-related death.|Cochran-Mantel-Haenszel|Relative risk, CI, and p-value were calculated based on CMH test stratified by index event strata.||Hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint. Inferential testing required demonstration of non-inferiority using both RR and RD plus demonstration of superiority for major bleeding.||1.1802|0.5965|0.3128
71122661|NCT02698371|141750841|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.011||||||Applied for rows/categories alfa/bravo/charlie of Marginal Discoloration-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Marginal Discoloration performance at 24 month follow-up recall.||||0.011
70944606|NCT04522778|141389555|OTHER|||||||0.029|||||||t-test, 1 sided|||A ratio of events per month was calculated for each participant. Participants were compared to themselves prior to intervention (i.e. event ratios pre intervention were compared to event ratios following intervention.)||||.029
70944607|NCT04522778|141389556|SUPERIORITY|||||||0.35|||||||t-test, 1 sided|||A ratio of events per month was calculated for each participant. Participants were compared to themselves prior to intervention (i.e. event ratios pre intervention were compared to event ratios following intervention.)||||.35
70944608|NCT04522778|141389557|SUPERIORITY|||||||0.334|||||||t-test, 1 sided|||||||.334
70944609|NCT04522778|141389558|SUPERIORITY||Odds Ratio (OR)|38.26|STANDARD_ERROR_OF_MEAN|50.195||0.005|TWO_SIDED|95.0|2.926154|500.4402|||Chi-squared|||||500.4402|2.926154|.005
70944610|NCT04522778|141389559|SUPERIORITY||Odds Ratio (OR)|30.975|STANDARD_ERROR_OF_MEAN|35.73483||0.003|TWO_SIDED|95.0|3.22|297.17|||Chi-squared|||||297.17|3.22|.003
70944611|NCT04522778|141389560|SUPERIORITY||Odds Ratio (OR)|27.36|STANDARD_ERROR_OF_MEAN|31.72||0.004|TWO_SIDED|95.0|2.82|265.45|||Chi-squared|||||265.45|2.82|.004
70944612|NCT04522778|141389561|SUPERIORITY||Odds Ratio (OR)|10.93|STANDARD_ERROR_OF_MEAN|10.345||0.011|TWO_SIDED|95.0|1.71|69.82|||Chi-squared|||||69.82|1.71|.011
70944613|NCT04522778|141389562|SUPERIORITY||Odds Ratio (OR)|0.298|STANDARD_ERROR_OF_MEAN|0.2189||0.099|TWO_SIDED|95.0|0.0706|1.258|||Chi-squared|||||1.258|.0706|.099
70944614|NCT04522778|141389563|SUPERIORITY||Odds Ratio (OR)|1.201|STANDARD_ERROR_OF_MEAN|1.201||0.312|TWO_SIDED|95.0|0.549|6.562|||Chi-squared|||||6.562|.549|.312
70944615|NCT04522778|141389564|SUPERIORITY||Odds Ratio (OR)|1.519|STANDARD_ERROR_OF_MEAN|2.022||0.753|TWO_SIDED|95.0|0.112|20.623|||Chi-squared|||||20.623|.112|.753
70944616|NCT04522778|141389565|SUPERIORITY||Odds Ratio (OR)|0.321|STANDARD_ERROR_OF_MEAN|0.257||0.156|TWO_SIDED|95.0|0.067|1.541|||Chi-squared|||||1.541|.067|.156
70944617|NCT04522778|141389566|SUPERIORITY||Odds Ratio (OR)|0.458|STANDARD_ERROR_OF_MEAN|0.358||0.318|TWO_SIDED|95.0|0.099|2.122|||Chi-squared|||||2.122|.099|.318
70944618|NCT04522778|141389567|SUPERIORITY||Odds Ratio (OR)|0.449|STANDARD_ERROR_OF_MEAN|0.882||0.684|TWO_SIDED|95.0|0.009|21.003|||Chi-squared|||||21.003|.009|.684
70944619|NCT04522778|141389568|SUPERIORITY||Odds Ratio (OR)|2.335|STANDARD_ERROR_OF_MEAN|2.683||0.46|TWO_SIDED|95.0|0.246|22.194|||Chi-squared|||||22.194|.246|.460
70944620|NCT04522778|141389569|SUPERIORITY||Odds Ratio (OR)|2.299|STANDARD_ERROR_OF_MEAN|2.47293||0.439|TWO_SIDED|95.0|0.279|18.927|||Chi-squared|||||18.927|.279|.439
70944621|NCT04522778|141389570|SUPERIORITY||Odds Ratio (OR)|1.634|STANDARD_ERROR_OF_MEAN|2.187||0.714|TWO_SIDED|95.0|0.119|22.514|||Chi-squared|||||22.514|.119|.714
70944622|NCT04522778|141389571|SUPERIORITY||Odds Ratio (OR)|0.379|STANDARD_ERROR_OF_MEAN|0.448||0.412|TWO_SIDED|95.0|0.037|3.842|||Chi-squared|||||3.842|.037|.412
70944623|NCT04522778|141389572|SUPERIORITY||Odds Ratio (OR)|0.579|STANDARD_ERROR_OF_MEAN|0.539||0.558|TWO_SIDED|95.0|0.094|3.582|||Chi-squared|||||3.582|.094|.558
70944624|NCT04522778|141389573|SUPERIORITY||Odds Ratio (OR)|0.688|STANDARD_ERROR_OF_MEAN|0.609||0.673|TWO_SIDED|95.0|0.121|3.9|||Chi-squared|||||3.90|.121|.673
70944625|NCT04522778|141389574|SUPERIORITY||Odds Ratio (OR)|0.674|STANDARD_ERROR_OF_MEAN|0.438||0.544|TWO_SIDED|95.0|0.189|2.406|||Chi-squared|||||2.406|.189|.544
70944626|NCT04522778|141389575|SUPERIORITY||Odds Ratio (OR)|1.88|STANDARD_ERROR_OF_MEAN|1.631||0.464|TWO_SIDED|95.0|0.345|10.278|||Chi-squared|||||10.278|.345|.464
70944627|NCT04522778|141389576|SUPERIORITY||Odds Ratio (OR)|5.595|STANDARD_ERROR_OF_MEAN|5.675||0.09|TWO_SIDED|95.0|0.766|40.854|||Chi-squared|||||40.854|.766|.090
70944628|NCT04522778|141389577|SUPERIORITY||Odds Ratio (OR)|0.987|STANDARD_ERROR_OF_MEAN|1.119||0.991|TWO_SIDED|95.0|0.107|9.114|||Chi-squared|||||9.114|.107|.991
71122662|NCT02698371|141750841|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.034||||||Applied for rows/categories alfa/bravo/charlie of Marginal Discoloration-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Marginal Discoloration performance at 24 month follow-up recall.||||0.034
70944629|NCT04522778|141389578|SUPERIORITY||Odds Ratio (OR)|4.239|STANDARD_ERROR_OF_MEAN|5.027||0.223|TWO_SIDED|95.0|0.415|43.326|||Chi-squared|||||43.326|.415|.223
70944630|NCT04522778|141389579|SUPERIORITY||Odds Ratio (OR)|2.199|STANDARD_ERROR_OF_MEAN|2.496||0.488|TWO_SIDED|95.0|0.238|20.348|||Chi-squared|||||20.348|.238|.488
70944631|NCT04522778|141389580|SUPERIORITY||Odds Ratio (OR)|0.177|STANDARD_ERROR_OF_MEAN|0.129||0.018|TWO_SIDED|95.0|0.0424|0.743|||Chi-squared|||||.743|.0424|.018
70944632|NCT04522778|141389581|SUPERIORITY||Odds Ratio (OR)|3.688|STANDARD_ERROR_OF_MEAN|4.358||0.269|TWO_SIDED|95.0|0.364|37.379|||Chi-squared|||||37.379|.364|.269
70944633|NCT04522778|141389582|SUPERIORITY||Odds Ratio (OR)|4.251|STANDARD_ERROR_OF_MEAN|3.829||0.108|TWO_SIDED|95.0|0.728|24.84|||Chi-squared|||||24.84|.728|.108
70944634|NCT04522778|141389583|SUPERIORITY||Odds Ratio (OR)|3.658|STANDARD_ERROR_OF_MEAN|2.99||0.113|TWO_SIDED|95.0|0.737|18.157|||Chi-squared|||||18.157|.737|.113
70944635|NCT04522778|141389584|SUPERIORITY||Odds Ratio (OR)|2.495|STANDARD_ERROR_OF_MEAN|1.156||0.049|TWO_SIDED|95.0|1.004|6.202|||Chi-squared|||||6.202|1.004|.049
70944636|NCT00312845|141389587|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Log Rank|||||||0.039
70944637|NCT00312845|141389588|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
70944638|NCT02188784|141389661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.03||||0.457|TWO_SIDED|95.0|-34.38|76.43|||Regression, Linear|||||76.43|-34.38|0.4570
70944639|NCT02188784|141389662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.77||||0.9487|TWO_SIDED|95.0|-24.12|22.59|||Regression, Linear|||Change from Baseline to Week 8||22.59|-24.12|0.9487
70944640|NCT02188784|141389662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.67||||0.1921|TWO_SIDED|95.0|-31.71|6.37|||Regression, Linear|||Change from Baseline to Week 16||6.37|-31.71|0.1921
70944641|NCT02188784|141389663|SUPERIORITY_OR_OTHER||Mean Difference (Net)|182.43||||0.4296|TWO_SIDED|95.0|-272.14|637.0|||Regression, Linear|||||637.0|-272.14|0.4296
70944642|NCT02188784|141389664|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.6||||0.0722|TWO_SIDED|95.0|-0.33|7.52|||Regression, Linear|||Change from baseline to week 8||7.52|-0.33|0.0722
70944643|NCT02188784|141389664|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.71||||0.6927|TWO_SIDED|95.0|-2.83|4.24|||Regression, Linear|||Change from baseline to week 16||4.24|-2.83|0.6927
70944644|NCT02188784|141389665|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.56||||0.0643|TWO_SIDED|95.0|-0.21|7.33|||Regression, Linear|||||7.33|-0.21|0.0643
70944645|NCT02188784|141389666|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77||||0.4006|TWO_SIDED|95.0|-1.04|2.58|||Regression, Linear|||||2.58|-1.04|0.4006
70944646|NCT01268098|141389675|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|5.0|||>|0.999|TWO_SIDED|95.0|-20.6|30.7||All hypothesis testings in this study were based on type I error of 0.05. Adjustment for multiplicity was not applied.|Fisher Exact|The 2-sided Fisher's Exact test was utilized to test for difference between the two dose arms.|The 2-sided asymptotic 95% confidence interval is based on normal approximation.|The null hypothesis corresponding to the primary efficacy endpoint is that the percentages of subjects who meet the endpoint criteria are the same for both dose arms. This sample size for this study was not based on the statistical considerations.||30.7|-20.6|>0.999
70944647|NCT01268098|141389676|SUPERIORITY_OR_OTHER_LEGACY|||||||0.258|TWO_SIDED||||||Fisher Exact|The 2-sided Fisher's Exact test was utilized to test for difference betweenthe two dose arms.||The null hypothesis corresponding to this endpoint is that the percentages of subjects who meet the endpoint criteria are the same for both dose arms.||||0.258
70944648|NCT01644188|141389704|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.8|||<|0.0001|TWO_SIDED|95.0|-34.4|-25.3||Threshold for significance ≤0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Alirocumab group was compared to ezetimibe group using an appropriate contrast statement.||-25.3|-34.4|<0.0001
70944649|NCT01644188|141389705|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.6|||<|0.0001|TWO_SIDED|95.0|-34.9|-26.2||Threshold for significance ≤0.05|Mixed Models Analysis||Alirocumab vs. ezetimibe|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-26.2|-34.9|<0.0001
70944650|NCT01644188|141389706|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.4|||<|0.0001|TWO_SIDED|95.0|-33.7|-25.1||Threshold for significance ≤0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-25.1|-33.7|<0.0001
70944651|NCT01644188|141389707|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.7|||<|0.0001|TWO_SIDED|95.0|-33.8|-25.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-25.6|-33.8|<0.0001
70944652|NCT01644188|141389708|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.4|||<|0.0001|TWO_SIDED|95.0|-26.0|-18.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-18.8|-26|<0.0001
70944653|NCT01644188|141389709|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.0|||<|0.0001|TWO_SIDED|95.0|-26.5|-19.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.6|-26.5|<0.0001
70944654|NCT01644188|141389710|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.9|||<|0.0001|TWO_SIDED|95.0|-26.9|-18.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-18.9|-26.9|<0.0001
70944655|NCT01644188|141389711|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.5|||<|0.0001|TWO_SIDED|95.0|-27.2|-19.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.7|-27.2|<0.0001
70944656|NCT01644188|141389712|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.7|||<|0.0001|TWO_SIDED|95.0|-17.7|-11.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-11.7|-17.7|<0.0001
70944657|NCT01644188|141389713|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.5|||<|0.0001|TWO_SIDED|95.0|-25.7|-19.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.2|-25.7|<0.0001
70944658|NCT01644188|141389714|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.0|||<|0.0001|TWO_SIDED|95.0|-25.6|-18.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-18.3|-25.6|<0.0001
70944659|NCT01644188|141389715|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.3|||<|0.0001|TWO_SIDED|95.0|-17.1|-11.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-11.6|-17.1|<0.0001
70944660|NCT01644188|141389716|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.2|||<|0.0001|TWO_SIDED|95.0|-36.3|-26.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-26.1|-36.3|<0.0001
71084728|NCT00643201|141675306|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.8151||||0.1554|TWO_SIDED|95.0|0.6146|1.0812||The test was stratified by index event strata using alpha=0.05 level of significance. Analysis was performed on the secondary efficacy dataset; there was no imputation of missing data.|Cochran-Mantel-Haenszel|Nominal p-value is reported.||Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.0812|0.6146|0.1554
71122663|NCT02698371|141750841|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.885||||||Applied for rows/categories alfa/bravo/charlie of Marginal Discoloration-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Marginal Discoloration performance at 24 month follow-up recall.||||0.885
70944661|NCT01644188|141389717|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.4|||<|0.0001|TWO_SIDED|95.0|3.7|7.9||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by Logistic regression model.|Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||7.9|3.7|<0.0001
70944662|NCT01644188|141389718|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.9|||<|0.0001|TWO_SIDED|95.0|3.9|8.8||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model|Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||8.8|3.9|<0.0001
70944663|NCT01644188|141389719|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-21.7|||<|0.0001|TWO_SIDED|95.0|-26.4|-17.0||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-17|-26.4|<0.0001
70944664|NCT01644188|141389720|SUPERIORITY_OR_OTHER||LS Mean Difference|8.1|||<|0.0001|TWO_SIDED|95.0|5.4|10.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||10.7|5.4|<0.0001
70944665|NCT01644188|141389721|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.3||||0.9117|TWO_SIDED|95.0|-5.1|4.6||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression.|Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||4.6|-5.1|0.9117
70944666|NCT01929876|141389734|SUPERIORITY_OR_OTHER||Ratio of least squares means|316.6|||||TWO_SIDED|90.0|268.1|374.0|||||LS means from analysis of variance (ANOVA), calculated by transforming the natural log means back to the linear scale (that is, geometric LS mean).|Ratio of Least squares (LS) means (Cobimetinib with Itraconazole/Cobimetinib alone) of natural log-transformed parameter (expressed as a percent).||374.0|268.1|
70944667|NCT01929876|141389735|SUPERIORITY_OR_OTHER||Ratio of LS means|672.3|||||TWO_SIDED|90.0|563.7|801.9|||||Ratio of LS means (Cobimetinib with Itraconazole/Cobimetinib alone) of natural log-transformed parameter (expressed as a percent). LS means from ANOVA, calculated by transforming the natural log means back to the linear scale.|Only participants with PK parameter data from both Period 1 Day 1 and Period 2 Day 4 (n=11) were included for statistical analyses.||801.9|563.7|
70944668|NCT01929876|141389737|SUPERIORITY_OR_OTHER||Ratio of LS means|583.9|||||TWO_SIDED|90.0|488.2|698.2|||||Ratio of LS means (Cobimetinib with Itraconazole/Cobimetinib alone) of natural log-transformed parameter (expressed as a percent). LS means from ANOVA, calculated by transforming the natural log means back to the linear scale.|||698.2|488.2|
70944669|NCT01222533|141389770|NON_INFERIORITY_OR_EQUIVALENCE|The standard bioequivalence range of 80 to 125% was pre-specified for Cmax,ss in order to assess the relative systemic exposure following inhalation of Tio R5 compared to Tio HH18. Bioequivalence was not used as a surrogate for efficacy.|Geometric mean ratio (percentage)|80.66|STANDARD_DEVIATION|43.4||0.4423||90.0|73.49|88.52||Maximum of two one-sided p-values for geometric mean ratio being outside interval 80 percent to 125 percent.|ANOVA||Standard deviation is actually the geometric coefficient of variation.|||88.52|73.49|0.4423
70944670|NCT01222533|141389771|NON_INFERIORITY_OR_EQUIVALENCE|The standard bioequivalence range of 80 to 125% was pre-specified for AUC0-6,ss in order to assess the relative systemic exposure following inhalation of Tio R5 compared to Tio HH18. Bioequivalence was not used as a surrogate for efficacy.|Geometric mean ratio (percentage)|75.99|STANDARD_DEVIATION|34.1||0.8683||90.0|70.44|81.98||Maximum of two one-sided p-values for geometric mean ratio being outside interval 80 percent to 125 percent.|ANOVA||Standard deviation is actually the geometric coefficient of variation.|||81.98|70.44|0.8683
71084729|NCT00643201|141675307|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7994||||0.1848|TWO_SIDED|95.0|0.5737|1.1137||The test was stratified by index event strata using alpha=0.05 level of significance. . Nominal p-value is reported.|Cochran-Mantel-Haenszel|Analysis was performed on the secondary efficacy dataset; there was no imputation of missing data.||Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.1137|0.5737|0.1848
70944671|NCT01222533|141389772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.014||||95.0|0.06|0.114|||||Tio R1.25-Placebo|||0.114|0.060|
70944672|NCT01222533|141389772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001||95.0|0.074|0.128|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo|||0.128|0.074|<0.0001
70944673|NCT01222533|141389772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001||95.0|0.094|0.148|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo|||0.148|0.094|<0.0001
70944674|NCT01222533|141389773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.012||||95.0|0.141|0.189|||||Tio R1.25-Placebo.|||0.189|0.141|
70944675|NCT01222533|141389773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001||95.0|0.161|0.209|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo|||0.209|0.161|<0.0001
70944676|NCT01222533|141389773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.191|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001||95.0|0.167|0.216|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo|||0.216|0.167|<0.0001
70944677|NCT01222533|141389774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.013||||95.0|0.13|0.18|||||Tio R1.25-Placebo|||0.180|0.130|
70944678|NCT01222533|141389774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001||95.0|0.155|0.205|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo|||0.205|0.155|<0.0001
71084730|NCT00643201|141675308|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6236||||0.0011|TWO_SIDED|95.0|0.4682|0.8306||The test was stratified by index event strata using alpha=0.05 level of significance. Nominal p-value is reported.|Cochran-Mantel-Haenszel|||Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||0.8306|0.4682|0.0011
71084731|NCT00643201|141675309|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5532|||<|0.0001|TWO_SIDED|95.0|0.4658|0.6569||The test was stratified by index event strata using alpha=0.05 level of significance. Nominal p-value is reported.|Cochran-Mantel-Haenszel|||Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||0.6569|0.4658|<0.0001
71084732|NCT00643201|141675310|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6347|||||TWO_SIDED|95.0|0.3735|1.0787|||Cochran-Mantel-Haenszel||Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.0787|0.3735|
71122664|NCT02698371|141750842|EQUIVALENCE|An alpha value of 0.05 was considered||||||1||||||Applied for rows/categories alfa/bravo/charlie of Color Match-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Color Match performance at 24 month follow-up recall.||||1.000
71122665|NCT02698371|141750842|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.317||||||Applied for rows/categories alfa/bravo/charlie of Color Match-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Color Match performance at 24 month follow-up recall.||||0.317
71122666|NCT02698371|141750842|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.403||||||Applied for rows/categories alfa/bravo/charlie of Color Match-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Color Match performance at 24 month follow-up recall.||||0.403
71122667|NCT02698371|141750843|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.02||||||Applied for rows/categories alfa/bravo/charlie of Retention-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Retention performance at 24 month follow-up recall.||||0.020
71122668|NCT02698371|141750843|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.02||||||Applied for rows/categories alfa/bravo/charlie of Retention-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Retention performance at 24 month follow-up recall.||||0.020
71122669|NCT02698371|141750843|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.04||||||Applied for rows/categories alfa/bravo/charlie of Retention-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Retention performance at 24 month follow-up recall.||||0.040
71122670|NCT02698371|141750844|EQUIVALENCE|An alpha value of 0.05 was considered|||||<|0.001||||||Applied for rows/categories alfa/bravo/charlie/delta of Marginal Integrity-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Marginal Integrity performance at 24 month follow-up recall.||||<0.001
71122671|NCT02698371|141750844|EQUIVALENCE|An alpha value of 0.05 was considered|||||<|0.001||||||Applied for rows/categories alfa/bravo/charlie/delta of Marginal Integrity-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Marginal Integrity performance at 24 month follow-up recall.||||<0.001
71122672|NCT02698371|141750844|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.211||||||Applied for rows/categories alfa/bravo/charlie/delta of Marginal Integrity-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Marginal Integrity performance at 24 month follow-up recall.||||0.211
71122673|NCT02698371|141750845|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.102||||||Applied for rows/categories No Evidence vs Evidence of Postoperative Sensitivity-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Postoperative Sensitivity performance at 24 month follow-up recall.||||0.102
71084733|NCT00643201|141675311|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0935|||||TWO_SIDED|95.0|0.6363|1.8793|||Cochran-Mantel-Haenszel||Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.8793|0.6363|
71084734|NCT00643201|141675312|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7521|||||TWO_SIDED|95.0|0.356|1.5889|||Cochran-Mantel-Haenszel||Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.5889|0.3560|
71084735|NCT00643201|141675313|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6539|||||TWO_SIDED|95.0|0.3419|1.2508|||Cochran-Mantel-Haenszel||Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.2508|0.3419|
71084736|NCT00643201|141675314|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7934|||||TWO_SIDED|95.0|0.5287|1.1906|||Cochran-Mantel-Haenszel||Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.1906|0.5287|
71084737|NCT00643201|141675315|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.307|||<|0.0001|TWO_SIDED|95.0|0.1728|0.5452||p-value calculated on the CMH test stratified by index event strata.|Cochran-Mantel-Haenszel||Relative risk and CI were calculated based on CMH test stratified by index event strata.|Hypothesis: apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint. As per the hierarchical statistical testing cascade, inferential testing for adjudicated major bleeding occurred because non-inferiority for VTE/VTE-related death (Primary efficacy endpoint) was demonstrated earlier. Rejection of the null hypothesis for equivalence for major bleeding allowed inferential testing for superiority of VTE/VTE-related death.||0.5452|0.1728|<0.0001
71084738|NCT00643201|141675316|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.441|||<|0.0001|TWO_SIDED|95.0|0.3566|0.5453||Tested at 2-sided alpha=0.05 significance.|Cochran-Mantel-Haenszel|Nominal p-value is reported.|Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint. Inferential testing was not conducted because the null hypothesis pertaining to superiority for VTE/VTE-related death was not rejected.||0.5453|0.3566|<0.0001
71084739|NCT00643201|141675317|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.4793|||<|0.0001|TWO_SIDED|95.0|0.3815|0.6022||Tested at 2-sided alpha=0.05 significance.|Cochran-Mantel-Haenszel|Nominal p-value is reported.|Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||0.6022|0.3815|<0.0001
71084740|NCT00643201|141675318|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6182|||<|0.0001|TWO_SIDED|95.0|0.5432|0.7034||Tested at 2-sided alpha=0.05 significance.|Cochran-Mantel-Haenszel|Nominal p-value is reported.|Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||0.7034|0.5432|<0.0001
71084741|NCT00643201|141675319|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5937|||<|0.0001|TWO_SIDED|95.0|0.5318|0.6629||Tested at 2-sided alpha=0.05 significance.|Cochran-Mantel-Haenszel|Nominal p-value is reported.|Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||0.6629|0.5318|<0.0001
71084742|NCT02346708|141675328|SUPERIORITY||Mean Difference (Final Values)|-2.07||||0.1|TWO_SIDED|95.0|-4.56|0.42||We determined whether there was a significant group difference between the real and sham treated PD-MCI patients on the DRS-2 change following rTMS using mixed model regression (MMR) to fit longitudinal models.|Mixed Models Analysis|degrees of freedom: 46||We estimated a sample size of 20 per group would provide at least 80% power at a significance level of 0.05 to detect a between-group difference of 10 on the Matthis Dementia Rating Scale-2, an effect size similar to prior studies of rivastigmine.||0.42|-4.56|0.1
71122674|NCT02698371|141750845|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.18||||||Applied for rows/categories No Evidence vs Evidence of Postoperative Sensitivity-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Postoperative Sensitivity performance at 24 month follow-up recall.||||0.180
71122675|NCT02698371|141750845|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.99||||||Applied for rows/categories No Evidence vs Evidence of Postoperative Sensitivity-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Postoperative Sensitivity performance at 24 month follow-up recall.||||0.990
71122676|NCT02698371|141750846|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.157||||||Applied for rows/categories No Evidence vs Evidence of Secondary Caries-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Secondary Caries performance at 24 month follow-up recall.||||0.157
71122677|NCT02698371|141750846|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.317||||||Applied for rows/categories No Evidence vs Evidence of Secondary Caries-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Secondary Caries performance at 24 month follow-up recall.||||0.317
71084743|NCT02976519|141675330|OTHER||Slope|1.2705|STANDARD_ERROR_OF_MEAN|0.0801|||TWO_SIDED|95.0|1.1067|1.4343|||||Based on the estimate for slope parameter (β), a 2-sided 95% confidence interval (CI) for the slope was computed. Standard error of the mean is actually standard error of slope.|Cmax. The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and PK endpoints.||1.4343|1.1067|
71084744|NCT02976519|141675330|OTHER||Slope|1.1361|STANDARD_ERROR_OF_MEAN|0.0859|||TWO_SIDED|95.0|0.9598|1.3123|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope.|Cmax,13. The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and PK endpoints.||1.3123|0.9598|
70944679|NCT01222533|141389774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.187|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001||95.0|0.162|0.211|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo|||0.211|0.162|<0.0001
70944680|NCT01222533|141389775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.028||||95.0|0.083|0.194|||||Tio R1.25-Placebo|||0.194|0.083|
71084745|NCT02976519|141675331|OTHER||Slope|1.2743|STANDARD_ERROR_OF_MEAN|0.0739|||TWO_SIDED|95.0|1.1231|1.4255|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope.|AUC0-12. The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and PK endpoints.||1.4255|1.1231|
71084746|NCT02976519|141675331|OTHER||Slope|1.0924|STANDARD_ERROR_OF_MEAN|0.0793|||TWO_SIDED|95.0|0.9296|1.2551|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope.|AUC0-12,13. The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and PK endpoints.||1.2551|0.9296|
71084747|NCT03416270|141675332|OTHER|||||||0.36||||||12 weeks|Wilcoxon (Mann-Whitney)|||||||0.36
71084748|NCT03416270|141675332|OTHER|||||||0.56||||||1 week|Wilcoxon (Mann-Whitney)|||||||0.56
70944681|NCT01222533|141389775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.133|0.244|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo|||0.244|0.133|<0.0001
70944682|NCT01222533|141389775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.236|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.18|0.292|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo|||0.292|0.180|<0.0001
70944683|NCT01222533|141389776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.283|STANDARD_ERROR_OF_MEAN|0.022||||95.0|0.241|0.326|||||Tio R1.25-Placebo|||0.326|0.241|
70944684|NCT01222533|141389776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.319|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.276|0.362|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo|||0.362|0.276|<0.0001
70944685|NCT01222533|141389776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.335|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.292|0.378|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo|||0.378|0.292|<0.0001
70944686|NCT01222533|141389777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.281|STANDARD_ERROR_OF_MEAN|0.023||||95.0|0.236|0.325|||||Tio R1.25-Placebo|||0.325|0.236|
70944687|NCT01222533|141389777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.324|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.279|0.369|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo|||0.369|0.279|<0.0001
70944688|NCT01222533|141389777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.339|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.294|0.384|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo|||0.384|0.294|<0.0001
70944689|NCT00526097|141389809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001||95.0|2.6|4.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.0|2.6|<0.0001
71084749|NCT03416270|141675333|OTHER|||||||0.303|||||||Wilcoxon (Mann-Whitney)|||||||0.303
71084750|NCT03416270|141675334|OTHER|||||||0.438|||||||Wilcoxon (Mann-Whitney)|||||||0.438
71122678|NCT02698371|141750846|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.334||||||Applied for rows/categories No Evidence vs Evidence of Secondary Caries-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Secondary Caries performance at 24 month follow-up recall.||||0.334
70944690|NCT00526097|141389810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001||95.0|3.5|5.2||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs)|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||5.2|3.5|<0.0001
71084751|NCT03416270|141675335|OTHER|||||||0.599|||||||Wilcoxon (Mann-Whitney)|||||||0.599
70944691|NCT00526097|141389811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001||95.0|2.7|4.3||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.3|2.7|<0.0001
70944692|NCT00526097|141389812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001||95.0|2.0|3.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||3.6|2.0|<0.0001
70944693|NCT00526097|141389813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001||95.0|1.8|3.4||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||3.4|1.8|<0.0001
71084752|NCT03416270|141675336|OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.92
71084753|NCT03416270|141675337|OTHER|||||||0.405|||||||Wilcoxon (Mann-Whitney)|||||||0.405
70944694|NCT00526097|141389814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001||95.0|4.1|5.8||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||5.8|4.1|<0.0001
70944695|NCT00526097|141389815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|STANDARD_ERROR_OF_MEAN|0.49|<|0.0001||95.0|5.8|7.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||7.7|5.8|<0.0001
71084754|NCT03416270|141675338|OTHER|||||||0.536|||||||Wilcoxon (Mann-Whitney)|||||||0.536
71084755|NCT03416270|141675339|OTHER|||||||0.443|||||||Wilcoxon (Mann-Whitney)|||||||0.443
71084756|NCT03416270|141675340|OTHER|||||||0.849|||||||Wilcoxon (Mann-Whitney)|||||||0.849
71084757|NCT03416270|141675341|OTHER|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
71084758|NCT03416270|141675342|OTHER|||||||0.844|||||||Wilcoxon (Mann-Whitney)|||||||0.844
71084759|NCT03416270|141675343|OTHER|||||||0.262|||||||Wilcoxon (Mann-Whitney)|||||||0.262
71084760|NCT03416270|141675344|OTHER|||||||0.802|||||||Wilcoxon (Mann-Whitney)|||||||0.802
71084761|NCT03416270|141675345|OTHER|||||||0.327|||||||Wilcoxon (Mann-Whitney)|||||||0.327
71084762|NCT03416270|141675346|OTHER|||||||0.618|||||||Wilcoxon (Mann-Whitney)|||||||0.618
71084763|NCT03416270|141675347|OTHER|||||||0.946|||||||Wilcoxon (Mann-Whitney)|||||||0.946
71084764|NCT03416270|141675348|OTHER|||||||0.53||||||12 week|Wilcoxon (Mann-Whitney)|||||||0.53
71084765|NCT03416270|141675348|OTHER|||||||0.89||||||1 week|Wilcoxon (Mann-Whitney)|||||||0.89
71122679|NCT02698371|141750847|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.132||||||Applied for rows/categories No Evidence vs Evidence of Gingival Bleeding-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Gingival Bleeding performance at 24 month follow-up recall.||||0.132
71084766|NCT03416270|141675349|OTHER|||||||0.26||||||12 weeks|Wilcoxon (Mann-Whitney)|||||||0.26
71122680|NCT02698371|141750847|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.257||||||Applied for rows/categories No Evidence vs Evidence of Gingival Bleeding-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Gingival Bleeding performance at 24 month follow-up recall.||||0.257
70944696|NCT00526097|141389816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|0.46|<|0.0001||95.0|3.8|5.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||5.6|3.8|<0.0001
71084767|NCT03416270|141675349|OTHER|||||||0.56||||||1 week|Wilcoxon (Mann-Whitney)|||||||0.56
71084768|NCT00928434|141675353|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was defined as a lower bound (LCL) of the 95% confidence interval for the difference between the intermittent and pooled continuous treatments, CADT, (intermittent - continuous) of greater than -12.5%.|Percentage difference|1.57|||||TWO_SIDED|95.0|-0.19|3.33||||||||3.33|-0.19|
71084769|NCT00313846|141675413|SUPERIORITY_OR_OTHER|||||||0.0026|||||||Kaplan-Meier estimate mean|||||||.0026
71084770|NCT01765296|141675422|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"The SD for the primary efficacy outcome measure (WOMAC-Pain Subscale in the index joint) has been assumed to be 11 units. A 10% between-group difference was chosen as the non-inferiority margin for this study. The following parameters were used to calculate the sample size needed for this non-inferiority study.~* Level of significance, α = 0.025(one-sided)~* Statistical power, 1-β = 0.95~* Difference between test group and comparison group, Δ=0, δ (\>0) = non-inferiority margin"||||||0.011|||||||ANCOVA|||The primary efficacy outcome measure is the change in the WOMAC-Pain Subscale in the index joint at Week 6 vs. pre-dose Baseline and was analyzed using a mixed effect ANCOVA. Statistical tests to determine superiority between two treatment arms, CG100649 2 mg and placebo, are two-sided, and Non-inferiority between two treatment arms, CG100649 2 mg and celecoxib 200 mg is based on a one-sided 97.5% confidence interval of the difference.||||0.011
71084771|NCT01765296|141675422|NON_INFERIORITY|"The SD for the primary efficacy outcome measure (WOMAC-Pain Subscale in the index joint) has been assumed to be 11 units. A 10% between-group difference was chosen as the non-inferiority margin for this study. The following parameters were used to calculate the sample size needed for this non-inferiority study.~* Level of significance, α = 0.025(one-sided)~* Statistical power, 1-β = 0.95~* Difference between test group and comparison group, Δ=0, δ (\>0) = non-inferiority margin"||||||0.425|||||||ANCOVA|||||||0.425
71084772|NCT03933449|141675424|SUPERIORITY||Hazard Ratio (HR)|0.55||||0.0015|TWO_SIDED|95.0|0.36|0.82||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate|||0.82|0.36|0.0015
71084773|NCT03933449|141675425|SUPERIORITY||Hazard Ratio (HR)|0.34||||0.0008|TWO_SIDED|95.0|0.17|0.69||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate|||0.69|0.17|0.0008
71084774|NCT03933449|141675426|SUPERIORITY||Hazard Ratio (HR)|0.55||||0.0021|TWO_SIDED|95.0|0.37|0.83||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate|||0.83|0.37|0.0021
71084775|NCT03933449|141675427|SUPERIORITY||Difference in Percentages|12.9||||0.0084|TWO_SIDED|95.0|2.7|24.5||One-sided p-value for testing. H0: difference in %=0 versus H1: difference in %\>0.|Miettinen & Nurminen method|||||24.5|2.7|0.0084
71084776|NCT03933449|141675428|SUPERIORITY||Difference in Percentages|17.1||||0.0403|TWO_SIDED|95.0|-2.3|38.0||One-sided p-value for testing. H0: difference in %=0 versus H1: difference in %\>0.|Miettinen & Nurminen method|||||38.0|-2.3|0.0403
71084777|NCT03933449|141675429|SUPERIORITY||Difference in Percentages|13.3||||0.0083|TWO_SIDED|95.0|2.8|25.2||One-sided p-value for testing. H0: difference in %=0 versus H1: difference in %\>0.|Miettinen & Nurminen method|||||25.2|2.8|0.0083
71084778|NCT03933449|141675430|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.177|TWO_SIDED|95.0|0.58|1.23||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate|||1.23|0.58|0.177
71084779|NCT03933449|141675431|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.238|TWO_SIDED|95.0|0.44|1.46||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate|||1.46|0.44|0.238
71084780|NCT03933449|141675432|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.171|TWO_SIDED|95.0|0.57|1.23||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate|||1.23|0.57|0.171
71084781|NCT03428100|141675464|SUPERIORITY||Odds Ratio (OR)|1.78||||0.071|TWO_SIDED|95.0|0.95|3.32|||Regression, Logistic|||||3.32|0.95|0.071
71122681|NCT02698371|141750847|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.918||||||Applied for rows/categories No Evidence vs Evidence of Gingival Bleeding-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Gingival Bleeding performance at 24 month follow-up recall.||||0.918
71084782|NCT03428100|141675464|SUPERIORITY||Odds Ratio (OR)|2.15||||0.031|TWO_SIDED|95.0|1.07|4.3|||Regression, Logistic|||||4.30|1.07|0.031
70944697|NCT00526097|141389817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8|STANDARD_ERROR_OF_MEAN|0.45|<|0.0001||95.0|2.9|4.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.7|2.9|<0.0001
71084783|NCT03428100|141675465|SUPERIORITY||Odds Ratio (OR)|1.34||||0.427|TWO_SIDED|95.0|0.65|2.77|||Regression, Logistic|||||2.77|0.65|0.427
71084784|NCT03428100|141675466|SUPERIORITY||Odds Ratio (OR)|1.35||||0.513|TWO_SIDED|95.0|0.55|3.35|||Regression, Logistic|||||3.35|0.55|0.513
71084785|NCT03428100|141675466|SUPERIORITY||Odds Ratio (OR)|1.6||||0.242|TWO_SIDED|95.0|0.73|3.53|||Regression, Logistic|||||3.53|0.73|0.242
71084786|NCT03428100|141675466|SUPERIORITY||Odds Ratio (OR)|2.54||||0.03|TWO_SIDED|95.0|1.09|5.9|||Regression, Logistic|||||5.90|1.09|0.030
71084787|NCT03428100|141675467|SUPERIORITY||Odds Ratio (OR)|1.32||||0.611|TWO_SIDED|95.0|0.45|3.83|||Regression, Logistic|||||3.83|0.45|0.611
71084788|NCT03428100|141675467|SUPERIORITY||Odds Ratio (OR)|1.59||||0.325|TWO_SIDED|95.0|0.63|3.99|||Regression, Logistic|||||3.99|0.63|0.325
71084789|NCT03428100|141675467|SUPERIORITY||Odds Ratio (OR)|2.29||||0.1|TWO_SIDED|95.0|0.85|6.14|||Regression, Logistic|||||6.14|0.85|0.100
71084790|NCT03428100|141675468|SUPERIORITY||Mean Difference (Final Values)|-17.65|STANDARD_ERROR_OF_MEAN|5.627||0.002|TWO_SIDED|95.0|-28.71|-6.58|||Mixed Models Analysis|||||-6.58|-28.71|0.002
71084791|NCT03428100|141675468|SUPERIORITY||Mean Difference (Final Values)|-13.35|STANDARD_ERROR_OF_MEAN|4.82||0.006|TWO_SIDED|95.0|-22.83|-3.87|||Mixed Models Analysis|||||-3.87|-22.83|0.006
71084792|NCT03428100|141675468|SUPERIORITY||Mean Difference (Final Values)|-20.62|STANDARD_ERROR_OF_MEAN|5.554||0.0002|TWO_SIDED|95.0|-31.54|-9.7|||Mixed Models Analysis|||||-9.70|-31.54|0.0002
71084793|NCT03428100|141675469|SUPERIORITY||Odds Ratio (OR)|4.14||||0.115|TWO_SIDED|95.0|0.71|24.29|||Regression, Logistic|||||24.29|0.71|0.115
71084794|NCT03428100|141675469|SUPERIORITY||Odds Ratio (OR)|5.85||||0.037|TWO_SIDED|95.0|1.11|30.88|||Regression, Logistic|||||30.88|1.11|0.037
71084795|NCT03428100|141675469|SUPERIORITY||Odds Ratio (OR)|4.78||||0.083|TWO_SIDED|95.0|0.81|28.08|||Regression, Logistic|||||28.08|0.81|0.083
71084796|NCT03428100|141675470|SUPERIORITY||Odds Ratio (OR)|3.28||||0.012|TWO_SIDED|95.0|1.29|8.32|||Regression, Logistic|||||8.32|1.29|0.012
71084797|NCT03428100|141675470|SUPERIORITY||Odds Ratio (OR)|3.71||||0.002|TWO_SIDED|95.0|1.59|8.66|||Regression, Logistic|||||8.66|1.59|0.002
71084798|NCT03428100|141675470|SUPERIORITY||Odds Ratio (OR)|6.85||||2e-05|TWO_SIDED|95.0|2.79|16.82|||Regression, Logistic|||||16.82|2.79|0.00002
71084799|NCT03428100|141675471|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.203||0.039|TWO_SIDED|95.0|-0.82|-0.02|||Mixed Models Analysis|||||-0.02|-0.82|0.039
71084800|NCT03428100|141675471|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.175||0.23|TWO_SIDED|95.0|-0.56|0.13|||Mixed Models Analysis|||||0.13|-0.56|0.23
71084801|NCT03428100|141675471|SUPERIORITY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.201||0.0001|TWO_SIDED|95.0|-1.18|-0.39|||Mixed Models Analysis|||||-0.39|-1.18|0.0001
71084802|NCT03428100|141675472|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.388||0.0714|TWO_SIDED|95.0|-1.47|0.06|||Mixed Models Analysis|||||0.06|-1.47|0.0714
71084803|NCT03428100|141675472|SUPERIORITY||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.337||0.0134|TWO_SIDED|95.0|-1.5|-0.17|||Mixed Models Analysis|||||-0.17|-1.50|0.0134
71084804|NCT03428100|141675472|SUPERIORITY||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|0.386||0.0002|TWO_SIDED|95.0|-2.21|-0.69|||Mixed Models Analysis|||||-0.69|-2.21|0.0002
71084805|NCT03428100|141675473|SUPERIORITY||Odds Ratio (OR)|1.71||||0.183|TWO_SIDED|95.0|0.78|3.75|||Regression, Logistic|||||3.75|0.78|0.183
71084806|NCT03428100|141675473|SUPERIORITY||Odds Ratio (OR)|1.54||||0.235|TWO_SIDED|95.0|0.76|3.11|||Regression, Logistic|||||3.11|0.76|0.235
71084807|NCT03428100|141675473|SUPERIORITY||Odds Ratio (OR)|1.01||||0.991|TWO_SIDED|95.0|0.43|2.36|||Regression, Logistic|||||2.36|0.43|0.991
71084808|NCT03428100|141675474|SUPERIORITY||Odds Ratio (OR)|1.41||||0.263|TWO_SIDED|95.0|0.77|2.57|||Regression, Logistic|||||2.57|0.77|0.263
71084809|NCT03428100|141675474|SUPERIORITY||Odds Ratio (OR)|1.89||||0.016|TWO_SIDED|95.0|1.13|3.19|||Regression, Logistic|||||3.19|1.13|0.016
71084810|NCT03428100|141675474|SUPERIORITY||Odds Ratio (OR)|1.93||||0.031|TWO_SIDED|95.0|1.06|3.52|||Regression, Logistic|||||3.52|1.06|0.031
71084811|NCT03428100|141675475|SUPERIORITY||Odds Ratio (OR)|1.97||||0.058|TWO_SIDED|95.0|0.98|3.96|||Regression, Logistic|||||3.96|0.98|0.058
71084812|NCT03428100|141675475|SUPERIORITY||Odds Ratio (OR)|1.77||||0.072|TWO_SIDED|95.0|0.95|3.32|||Regression, Logistic|||||3.32|0.95|0.072
71084813|NCT03428100|141675475|SUPERIORITY||Odds Ratio (OR)|1.56||||0.224|TWO_SIDED|95.0|0.76|3.18|||Regression, Logistic|||||3.18|0.76|0.224
71084814|NCT03428100|141675476|SUPERIORITY||Odds Ratio (OR)|5.03||||0.265|TWO_SIDED|95.0|0.29|86.08|||Regression, Logistic|||||86.08|0.29|0.265
71084815|NCT03428100|141675476|SUPERIORITY||Odds Ratio (OR)|2.54||||0.52|TWO_SIDED|95.0|0.15|43.09|||Regression, Logistic|||||43.09|0.15|0.520
71084816|NCT03428100|141675476|SUPERIORITY||Odds Ratio (OR)|7.17||||0.164|TWO_SIDED|95.0|0.45|99.99|||Regression, Logistic|||||99.99|0.45|0.164
71084817|NCT03428100|141675477|SUPERIORITY||Mean Difference (Final Values)|-6.08|STANDARD_ERROR_OF_MEAN|2.948||0.04|TWO_SIDED|95.0|-11.88|-0.29|||Mixed Models Analysis|||||-0.29|-11.88|0.040
71084818|NCT03428100|141675477|SUPERIORITY||Mean Difference (Final Values)|-6.56|STANDARD_ERROR_OF_MEAN|2.533||0.01|TWO_SIDED|95.0|-11.54|-1.58|||Mixed Models Analysis|||||-1.58|-11.54|0.010
71084819|NCT03428100|141675477|SUPERIORITY||Mean Difference (Final Values)|-9.77|STANDARD_ERROR_OF_MEAN|2.919|<|0.001|TWO_SIDED|95.0|-15.51|-4.03|||Mixed Models Analysis|||||-4.03|-15.51|<0.001
71084820|NCT03428100|141675478|SUPERIORITY||Odds Ratio (OR)|4.75||||0.265|TWO_SIDED|95.0|0.31|73.93|||Regression, Logistic|||||73.93|0.31|0.265
71084821|NCT03428100|141675478|SUPERIORITY||Odds Ratio (OR)|2.5||||0.511|TWO_SIDED|95.0|0.16|38.4|||Regression, Logistic|||||38.40|0.16|0.511
71084822|NCT03428100|141675478|SUPERIORITY||Odds Ratio (OR)|4.95||||0.253|TWO_SIDED|95.0|0.32|77.11|||Regression, Logistic|||||77.11|0.32|0.253
71084823|NCT03428100|141675479|SUPERIORITY||Mean Difference (Final Values)|-6.21|STANDARD_ERROR_OF_MEAN|3.078||0.044|TWO_SIDED|95.0|-12.26|-0.16|||Mixed Models Analysis|||||-0.16|-12.26|0.044
71084824|NCT03428100|141675479|SUPERIORITY||Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|2.632||0.037|TWO_SIDED|95.0|-10.67|-0.32|||Mixed Models Analysis|||||-0.32|-10.67|0.037
71084825|NCT03428100|141675479|SUPERIORITY||Mean Difference (Final Values)|-8.41|STANDARD_ERROR_OF_MEAN|3.03||0.006|TWO_SIDED|95.0|-14.37|-2.45|||Mixed Models Analysis|||||-2.45|-14.37|0.006
71084826|NCT03428100|141675480|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>.999
71084827|NCT03428100|141675480|SUPERIORITY|||||||0.797|||||||Fisher Exact|||||||0.797
71084828|NCT03428100|141675480|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>.999
71084829|NCT03428100|141675481|SUPERIORITY||Mean Difference (Final Values)|8.62|STANDARD_ERROR_OF_MEAN|4.49||0.056|TWO_SIDED|95.0|-0.22|17.45|||ANCOVA|||||17.45|-0.22|0.056
71084830|NCT03428100|141675481|SUPERIORITY||Mean Difference (Final Values)|5.48|STANDARD_ERROR_OF_MEAN|3.92||0.164|TWO_SIDED|95.0|-2.24|13.19|||ANCOVA|||||13.19|-2.24|0.164
71084831|NCT03428100|141675481|SUPERIORITY||Mean Difference (Final Values)|7.25|STANDARD_ERROR_OF_MEAN|4.53||0.11|TWO_SIDED|95.0|-1.66|16.15|||ANCOVA|||||16.15|-1.66|0.110
71084832|NCT03428100|141675482|SUPERIORITY||Mean Difference (Final Values)|-48.06|STANDARD_ERROR_OF_MEAN|35.63||0.178|TWO_SIDED|95.0|-118.0|21.88|||ANOVA|||||21.88|-118.00|0.178
71084833|NCT03428100|141675482|SUPERIORITY||Mean Difference (Final Values)|-56.9|STANDARD_ERROR_OF_MEAN|30.9||0.066|TWO_SIDED|95.0|-117.56|3.77|||ANOVA|||||3.77|-117.56|0.066
71084834|NCT03428100|141675482|SUPERIORITY||Mean Difference (Final Values)|-71.42|STANDARD_ERROR_OF_MEAN|35.57||0.045|TWO_SIDED|95.0|-141.24|-1.6|||ANOVA|||||-1.60|-141.24|0.045
71084835|NCT03428100|141675483|SUPERIORITY||Mean Difference (Final Values)|-11.32|STANDARD_ERROR_OF_MEAN|6.62||0.088|TWO_SIDED|95.0|-24.33|1.7|||Mixed Models Analysis|||||1.70|-24.33|0.088
71084836|NCT03428100|141675483|SUPERIORITY||Mean Difference (Final Values)|-15.41|STANDARD_ERROR_OF_MEAN|5.725||0.007|TWO_SIDED|95.0|-26.67|-4.16|||Mixed Models Analysis|||||-4.16|-26.67|0.007
71084837|NCT03428100|141675483|SUPERIORITY||Mean Difference (Final Values)|-19.76|STANDARD_ERROR_OF_MEAN|6.583||0.003|TWO_SIDED|95.0|-32.71|-6.82|||Mixed Models Analysis|||||-6.82|-32.71|0.003
71084838|NCT03428100|141675484|SUPERIORITY||Mean Difference (Final Values)|-14.0|STANDARD_ERROR_OF_MEAN|7.263||0.055|TWO_SIDED|95.0|-28.28|0.28|||Mixed Models Analysis|||||0.28|-28.28|0.055
71084839|NCT03428100|141675484|SUPERIORITY||Mean Difference (Final Values)|-14.76|STANDARD_ERROR_OF_MEAN|6.297||0.02|TWO_SIDED|95.0|-27.15|-2.38|||Mixed Models Analysis|||||-2.38|-27.15|0.020
71084840|NCT03428100|141675484|SUPERIORITY||Mean Difference (Final Values)|-17.82|STANDARD_ERROR_OF_MEAN|7.216||0.014|TWO_SIDED|95.0|-32.01|-3.62|||Mixed Models Analysis|||||-3.62|-32.01|0.014
71084841|NCT03428100|141675485|SUPERIORITY||Mean Difference (Final Values)|-2.06|STANDARD_ERROR_OF_MEAN|1.229||0.095|TWO_SIDED|95.0|-4.47|-0.36|||Mixed Models Analysis|||||-0.36|-4.47|0.095
71084842|NCT03428100|141675485|SUPERIORITY||Mean Difference (Final Values)|-3.09|STANDARD_ERROR_OF_MEAN|1.057||0.004|TWO_SIDED|95.0|-5.16|-1.01|||Mixed Models Analysis|||||-1.01|-5.16|0.004
71084843|NCT03428100|141675485|SUPERIORITY||Mean Difference (Final Values)|-5.09|STANDARD_ERROR_OF_MEAN|1.216|<|0.001|TWO_SIDED|95.0|-7.48|-2.7|||Mixed Models Analysis|||||-2.70|-7.48|<0.001
71084844|NCT03428100|141675486|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.146||0.097|TWO_SIDED|95.0|-0.53|0.04|||Mixed Models Analysis|||||0.04|-0.53|0.097
71084845|NCT03428100|141675486|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.126||0.033|TWO_SIDED|95.0|-0.52|-0.02|||Mixed Models Analysis|||||-0.02|-0.52|0.033
71084846|NCT03428100|141675486|SUPERIORITY||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.145|<|0.001|TWO_SIDED|95.0|-0.86|-0.29|||Mixed Models Analysis|||||-0.29|-0.86|<0.001
71084847|NCT03428100|141675487|SUPERIORITY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.516||0.272|TWO_SIDED|95.0|-1.58|0.45|||Mixed Models Analysis|||Anxiety||0.45|-1.58|0.272
71084848|NCT03428100|141675487|SUPERIORITY||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.446||0.013|TWO_SIDED|95.0|-1.99|-0.24|||Mixed Models Analysis|||Anxiety||-0.24|-1.99|0.013
71084849|NCT03428100|141675487|SUPERIORITY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.511||0.099|TWO_SIDED|95.0|-1.85|0.16|||Mixed Models Analysis|||Anxiety||0.16|-1.85|0.099
71084850|NCT03428100|141675487|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.519||0.584|TWO_SIDED|95.0|-1.3|0.74|||Mixed Models Analysis|||Depression||0.74|-1.30|0.584
71084851|NCT03428100|141675487|SUPERIORITY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.448||0.162|TWO_SIDED|95.0|-1.51|0.25|||Mixed Models Analysis|||Depression||0.25|-1.51|0.162
71084852|NCT03428100|141675487|SUPERIORITY||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|0.515||0.024|TWO_SIDED|95.0|-2.18|-0.15|||Mixed Models Analysis|||Depression||-0.15|-2.18|0.024
71084853|NCT03428100|141675488|SUPERIORITY||Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|1.018||0.228|TWO_SIDED|95.0|-3.23|0.77|||Mixed Models Analysis|||||0.77|-3.23|0.228
70944698|NCT00526097|141389818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001||95.0|2.9|4.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.6|2.9|<0.0001
70944699|NCT00526097|141389819|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||The log-rank test was used to calculate the p-value and to test for differences between the treatment groups.||||<0.0001
70856376|NCT00545129|141199463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.68||0.701|TWO_SIDED|95.0|-1.68|1.15|||ANCOVA|||Change at Week 8 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.15|-1.68|0.701
70944700|NCT00526097|141389820|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04|||<|0.0001||95.0|1.62|2.57|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||2.57|1.62|<0.0001
70944701|NCT00526097|141389821|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75|||<|0.0001||95.0|1.44|2.13|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||2.13|1.44|<0.0001
71084854|NCT03428100|141675488|SUPERIORITY||Mean Difference (Final Values)|-1.62|STANDARD_ERROR_OF_MEAN|0.876||0.065|TWO_SIDED|95.0|-3.35|0.1|||Mixed Models Analysis|||||0.10|-3.35|0.065
70856377|NCT00545129|141199463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.59||0.453|TWO_SIDED|95.0|-1.68|0.77|||ANCOVA|||Change at Week 1 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.77|-1.68|0.453
70856378|NCT00545129|141199463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.67||0.258|TWO_SIDED|95.0|-2.15|0.6|||ANCOVA|||Change at Week 2 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.60|-2.15|0.258
70856379|NCT00545129|141199463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.64||0.736|TWO_SIDED|95.0|-1.53|1.09|||ANCOVA|||Change at Week 4 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.09|-1.53|0.736
70856380|NCT00545129|141199463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.64||0.491|TWO_SIDED|95.0|-1.76|0.87|||ANCOVA|||Change at Week 6 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.87|-1.76|0.491
70856381|NCT00545129|141199463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.62||0.695|TWO_SIDED|95.0|-1.53|1.04|||ANCOVA|||Change at Week 8 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.04|-1.53|0.695
70856382|NCT00545129|141199464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.6||0.897|TWO_SIDED|95.0|-1.34|1.19|||ANCOVA|||Change at Week 1 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.19|-1.34|0.897
70856383|NCT00545129|141199464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.56||0.643|TWO_SIDED|95.0|-0.9|1.43|||ANCOVA|||Change at Week 2 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.43|-0.90|0.643
70856384|NCT00545129|141199464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.51||0.464|TWO_SIDED|95.0|-1.45|0.68|||ANCOVA|||Change at Week 4 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.68|-1.45|0.464
70944702|NCT00526097|141389822|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.08|||<|0.0001||95.0|1.62|2.66|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||2.66|1.62|<0.0001
70856385|NCT00545129|141199464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.56||0.593|TWO_SIDED|95.0|-1.46|0.86|||ANCOVA|||Change at Week 6 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.86|-1.46|0.593
70856386|NCT00545129|141199464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.61||0.423|TWO_SIDED|95.0|-1.77|0.77|||ANCOVA|||Change at Week 8 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.77|-1.77|0.423
70856387|NCT00545129|141199464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.65||0.805|TWO_SIDED|95.0|-1.21|1.54|||ANCOVA|||Change at Week 1 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.54|-1.21|0.805
70944703|NCT00526097|141389823|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7|||<|0.0001||95.0|1.37|2.11|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||2.11|1.37|<0.0001
70856388|NCT00545129|141199464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.68||0.882|TWO_SIDED|95.0|-1.3|1.51|||ANCOVA|||Change at Week 2 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.51|-1.30|0.882
70856389|NCT00545129|141199464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.63||0.446|TWO_SIDED|95.0|-1.79|0.81|||ANCOVA|||Change at Week 4 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.81|-1.79|0.446
70856390|NCT00545129|141199464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.68||0.604|TWO_SIDED|95.0|-1.77|1.05|||ANCOVA|||Change at Week 6 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.05|-1.77|0.604
71084855|NCT03428100|141675488|SUPERIORITY||Mean Difference (Final Values)|-3.01|STANDARD_ERROR_OF_MEAN|1.007||0.003|TWO_SIDED|95.0|-4.99|-1.02|||Mixed Models Analysis|||||-1.02|-4.99|0.003
71122682|NCT03734029|141750848|SUPERIORITY||Cox Proportional Hazard|0.5085|||<|0.0001|TWO_SIDED|95.0|0.4012|0.6444||Two-sided p-value from stratified log-rank test, Hazard ratio and 95% CI from stratified Cox proportional hazards model using stratification factors: HER2 status, number of prior lines of chemotherapy, hormone Receptor/CDK status, as defined by IXRS.|Log Rank|||||0.6444|0.4012|<0.0001
71122683|NCT00131456|141750865|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||Regression, Logistic|||Logistic regression was used to analyze all dichotomous outcomes. The dichotomous primary outcome marijuana abstinence was modeled using independent predictors: treatment(Venlafaxine vs. Placebo) and baseline urine THC level. The initial analysis included an interaction between treatment and baseline urine THC levels which was deemed not significant and omitted from the final logistic model.||||<0.01
70944704|NCT00526097|141389824|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52|||<|0.0001||95.0|1.24|1.88|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||1.88|1.24|<0.0001
70856391|NCT00545129|141199464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.76||0.393|TWO_SIDED|95.0|-2.24|0.91|||ANCOVA|||Change at Week 8 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.91|-2.24|0.393
70944705|NCT00526097|141389825|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.13|||<|0.0001||95.0|4.28|68.66|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||68.66|4.28|<0.0001
70944706|NCT00526097|141389826|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.46|||<|0.0001||95.0|1.81|3.35|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||3.35|1.81|<0.0001
71122684|NCT00262847|141750866|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.954||||0.448||95.0|0.844|1.078|||Regression, Cox|Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.||||1.078|0.844|0.448
71122685|NCT00262847|141750866|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.765|||<|0.001||95.0|0.676|0.866|||Regression, Cox|Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.||||0.866|0.676|<0.001
71122686|NCT00262847|141750867|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.069||||0.41||95.0|0.912|1.255|||Regression, Cox|Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.||||1.255|0.912|0.410
70856392|NCT00545129|141199464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.79||0.399|TWO_SIDED|95.0|-2.33|0.97|||ANCOVA|||Change at Week 1 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.97|-2.33|0.399
70856393|NCT00545129|141199464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.75||0.876|TWO_SIDED|95.0|-1.43|1.66|||ANCOVA|||Change at Week 2 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.66|-1.43|0.876
70944707|NCT00526097|141389827|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.0025||95.0|1.32|4.74|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||4.74|1.32|0.0025
70856394|NCT00545129|141199464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.66||0.74|TWO_SIDED|95.0|-1.58|1.14|||ANCOVA|||Change at Week 4 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.14|-1.58|0.740
70944708|NCT00526097|141389828|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.08||||0.0105||95.0|1.26|13.24|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||13.24|1.26|0.0105
70944709|NCT00526097|141389829|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.4002||95.0|0.52|6.47|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||6.47|0.52|0.4002
71122687|NCT00262847|141750867|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.131||95.0|0.746|1.039|||Regression, Cox|Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.||||1.039|0.746|0.131
71122688|NCT03880838|141750878|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.391|TWO_SIDED||||||Regression, Linear|||In this contrast, letter was compared against all other conditions (coded into one category and set as the reference group). The key outcome is the interaction between conditions and time (2019 as the reference group).||||.391
71122689|NCT03880838|141750878|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.861|TWO_SIDED||||||Regression, Linear|||In this contrast, no contact control was compared against all other conditions (coded into one category and set as the reference group). The key outcome is the interaction between conditions and time (2019 as the reference group).||||.861
71122690|NCT03880838|141750878|SUPERIORITY||Slope|-0.02|STANDARD_DEVIATION|0.01||0.835|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.835
71122691|NCT03880838|141750878|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.877|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.877
71122692|NCT03880838|141750878|SUPERIORITY||Slope|0.004|STANDARD_ERROR_OF_MEAN|0.01||0.969|TWO_SIDED||||||Regression, Logistic|||In this contrast, both nudge conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.969
71122693|NCT03880838|141750878|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.09||0.893|TWO_SIDED||||||Regression, Linear|||In this contrast, no nudge conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.893
71122694|NCT03880838|141750878|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.1||0.689|TWO_SIDED||||||Regression, Linear|||In this contrast, In this contrast, prevention conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.689
71122695|NCT03880838|141750878|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.1||0.427|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.427
71122696|NCT03880838|141750878|SUPERIORITY||Slope|0.07|STANDARD_ERROR_OF_MEAN|0.1||0.504|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.504
71122697|NCT03880838|141750878|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.09||0.893|TWO_SIDED||||||Regression, Linear|||In this contrast, no nudge conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.893
71122698|NCT03880838|141750878|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.09||0.918|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.918
71122699|NCT03880838|141750878|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.09||0.755|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.755
71122700|NCT03880838|141750878|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.09||0.858|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.858
71122701|NCT03880838|141750879|SUPERIORITY||Slope|0.36|STANDARD_ERROR_OF_MEAN|0.46||0.436|TWO_SIDED||||||Regression, Linear|||In this contrast, letter was compared against all other conditions (coded into one category and set as the reference group). The key outcome is the interaction between conditions and time (2019 as the reference group).||||.436
71122702|NCT03880838|141750879|SUPERIORITY||Slope|-0.27|STANDARD_ERROR_OF_MEAN|0.45||0.539|TWO_SIDED||||||Regression, Linear|||In this contrast, no contact control was compared against all other conditions (coded into one category and set as the reference group). The key outcome is the interaction between conditions and time (2019 as the reference group).||||.539
71122703|NCT03880838|141750879|SUPERIORITY||Slope|0.005|STANDARD_ERROR_OF_MEAN|0.66||0.994|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.994
71122704|NCT03880838|141750879|SUPERIORITY||Slope|-0.25|STANDARD_ERROR_OF_MEAN|0.66||0.7|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.700
71122705|NCT03880838|141750879|SUPERIORITY||Slope|0.75|STANDARD_ERROR_OF_MEAN|0.66||0.258|TWO_SIDED||||||Regression, Logistic|||In this contrast, both nudge conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.258
71122706|NCT03880838|141750879|SUPERIORITY||Slope|-0.49|STANDARD_ERROR_OF_MEAN|0.62||0.428|TWO_SIDED||||||Regression, Linear|||In this contrast, no nudge conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.428
71084856|NCT03428100|141675489|SUPERIORITY||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|3.339||0.784|TWO_SIDED|95.0|-7.5|5.67|||Mixed Models Analysis|||Change from Baseline (CFB) Absenteeism||5.67|-7.50|0.784
71084857|NCT03428100|141675489|SUPERIORITY||Mean Difference (Final Values)|1.79|STANDARD_ERROR_OF_MEAN|2.813||0.525|TWO_SIDED|95.0|-3.75|7.34|||Mixed Models Analysis|||CFB Absenteeism||7.34|-3.75|0.525
70944710|NCT00526097|141389830|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||1||95.0|0.37|3.77|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||3.77|0.37|1.0000
71084858|NCT03428100|141675489|SUPERIORITY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|3.204||0.947|TWO_SIDED|95.0|-6.11|6.53|||Mixed Models Analysis|||CFB Absenteeism||6.53|-6.11|0.947
71084859|NCT03428100|141675489|SUPERIORITY||Mean Difference (Final Values)|3.06|STANDARD_ERROR_OF_MEAN|4.409||0.488|TWO_SIDED|95.0|-5.62|11.74|||Mixed Models Analysis|||CFB Presenteeism||11.74|-5.62|0.488
71084860|NCT03428100|141675489|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|3.72||0.936|TWO_SIDED|95.0|-7.02|7.62|||Mixed Models Analysis|||CFB Presenteeism||7.62|-7.02|0.936
71084861|NCT03428100|141675489|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|4.267||0.991|TWO_SIDED|95.0|-8.35|8.45|||Mixed Models Analysis|||CFB Presenteeism||8.45|-8.35|0.991
71084862|NCT03428100|141675489|SUPERIORITY||Mean Difference (Final Values)|1.15|STANDARD_ERROR_OF_MEAN|4.938||0.816|TWO_SIDED|95.0|-8.57|10.88|||Mixed Models Analysis|||CFB Work Productivity Loss||10.88|-8.57|0.816
71084863|NCT03428100|141675489|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|4.178||0.971|TWO_SIDED|95.0|-8.08|8.38|||Mixed Models Analysis|||CFB Work Productivity Loss||8.38|-8.08|0.971
71084864|NCT03428100|141675489|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|4.804||0.852|TWO_SIDED|95.0|-10.36|8.56|||Mixed Models Analysis|||CFB Work Productivity Loss||8.56|-10.36|0.852
71084865|NCT03428100|141675489|SUPERIORITY||Mean Difference (Final Values)|-1.99|STANDARD_ERROR_OF_MEAN|3.877||0.607|TWO_SIDED|95.0|-9.61|5.63|||Mixed Models Analysis|||CFB Activity Impairment||5.63|-9.61|0.607
71084866|NCT03428100|141675489|SUPERIORITY||Mean Difference (Final Values)|-4.4|STANDARD_ERROR_OF_MEAN|3.319||0.186|TWO_SIDED|95.0|-10.92|2.12|||Mixed Models Analysis|||CFB Activity Impairment||2.12|-10.92|0.186
71084867|NCT03428100|141675489|SUPERIORITY||Mean Difference (Final Values)|-7.45|STANDARD_ERROR_OF_MEAN|3.82||0.052|TWO_SIDED|95.0|-14.96|0.06|||Mixed Models Analysis|||CFB Activity Impairment||0.06|-14.96|0.052
71084868|NCT03428100|141675490|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.022||0.131|TWO_SIDED|95.0|-0.01|0.08|||Mixed Models Analysis|||CFB US Health State Index||0.08|-0.01|0.131
71084869|NCT03428100|141675490|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.019||0.017|TWO_SIDED|95.0|0.01|0.08|||Mixed Models Analysis|||CFB US Health State Index||0.08|0.01|0.017
71084870|NCT03428100|141675490|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.022||0.003|TWO_SIDED|95.0|0.02|0.11|||Mixed Models Analysis|||CFB US Health State Index||0.11|0.02|0.003
71084871|NCT03428100|141675490|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.031||0.102|TWO_SIDED|95.0|-0.01|0.11|||Mixed Models Analysis|||CFB UK Health State Index||0.11|-0.01|0.102
71084872|NCT03428100|141675490|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.027||0.014|TWO_SIDED|95.0|0.01|0.12|||Mixed Models Analysis|||CFB UK Health State Index||0.12|0.01|0.014
71084873|NCT03428100|141675490|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.031||0.003|TWO_SIDED|95.0|0.03|0.15|||Mixed Models Analysis|||CFB UK Health State Index||0.15|0.03|0.003
71084874|NCT03428100|141675491|SUPERIORITY||Mean Difference (Final Values)|3.99|STANDARD_ERROR_OF_MEAN|3.256||0.221|TWO_SIDED|95.0|-2.41|10.39|||Mixed Models Analysis|||||10.39|-2.41|0.221
71084875|NCT03428100|141675491|SUPERIORITY||Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|2.807||0.689|TWO_SIDED|95.0|-4.4|6.65|||Mixed Models Analysis|||||6.65|-4.40|0.689
71084876|NCT03428100|141675491|SUPERIORITY||Mean Difference (Final Values)|3.39|STANDARD_ERROR_OF_MEAN|3.226||0.294|TWO_SIDED|95.0|-2.95|9.74|||Mixed Models Analysis|||||9.74|-2.95|0.294
71084877|NCT03428100|141675492|SUPERIORITY||Odds Ratio (OR)|1.33||||0.382|TWO_SIDED|95.0|0.7|2.54|||Regression, Logistic|||||2.54|0.70|0.382
70944711|NCT00526097|141389831|SUPERIORITY_OR_OTHER|||||||0.0951|||||||Fisher Exact|||||||0.0951
71084878|NCT03428100|141675492|SUPERIORITY||Odds Ratio (OR)|1.15||||0.638|TWO_SIDED|95.0|0.65|2.02|||Regression, Logistic|||||2.02|0.65|0.638
71084879|NCT03428100|141675492|SUPERIORITY||Odds Ratio (OR)|1.56||||0.169|TWO_SIDED|95.0|0.83|2.96|||Regression, Logistic|||||2.96|0.83|0.169
71084880|NCT03428100|141675493|SUPERIORITY||LS Mean Difference (Final Values)|-7.36|STANDARD_ERROR_OF_MEAN|9.674||0.447|TWO_SIDED|95.0|-26.38|11.66|||Regression, Linear|||||11.66|-26.38|0.447
71084881|NCT03428100|141675493|SUPERIORITY||LS Mean Difference (Final Values)|-3.88|STANDARD_ERROR_OF_MEAN|8.454||0.646|TWO_SIDED|95.0|-20.5|12.74|||Regression, Linear|||||12.74|-20.50|0.646
71084882|NCT03428100|141675493|SUPERIORITY||LS Mean Difference (Final Values)|-17.18|STANDARD_ERROR_OF_MEAN|9.64||0.075|TWO_SIDED|95.0|-36.14|1.77|||Regression, Linear|||||1.77|-36.14|0.075
71084883|NCT04556760|141675511|OTHER||Mean Difference (Final Values)|-132.9528||||0.036|TWO_SIDED|95.0|-256.5082|-9.3973|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||-9.3973|-256.5082|0.036
71084884|NCT04556760|141675511|OTHER||Mean Difference (Final Values)|-142.033||||0.432|TWO_SIDED|95.0|-554.8722|270.8061|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||270.8061|-554.8722|0.432
71084885|NCT04556760|141675511|OTHER||Mean Difference (Final Values)|-126.8829||||0.03|TWO_SIDED|95.0|-236.0426|-17.7233|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||-17.7233|-236.0426|0.030
71084886|NCT04556760|141675512|OTHER||Mean Difference (Final Values)|-1.5067|||<|0.001|TWO_SIDED|95.0|-2.082|-0.9314|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||-0.9314|-2.0820|<0.001
71084887|NCT04556760|141675512|OTHER||Mean Difference (Final Values)|-1.1099|||<|0.001|TWO_SIDED|95.0|-1.7257|-0.4941|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||-0.4941|-1.7257|<0.001
71084888|NCT04556760|141675512|OTHER||Mean Difference (Final Values)|-0.1601||||0.547||95.0|-0.693|0.3729|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||0.3729|-0.6930|0.547
70856395|NCT00545129|141199464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.69||0.854|TWO_SIDED|95.0|-1.56|1.31|||ANCOVA|||Change at Week 6 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.31|-1.56|0.854
70856396|NCT00545129|141199464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.78||0.436|TWO_SIDED|95.0|-2.24|1.0|||ANCOVA|||Change at Week 8 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.00|-2.24|0.436
70856397|NCT00545129|141199464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.72||0.087|TWO_SIDED|95.0|-2.81|0.21|||ANCOVA|||Change at Week 1 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.21|-2.81|0.087
70856398|NCT00545129|141199464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.75||0.278|TWO_SIDED|95.0|-2.4|0.72|||ANCOVA|||Change at Week 2 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.72|-2.40|0.278
70856399|NCT00545129|141199464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.69||0.548|TWO_SIDED|95.0|-1.84|1.0|||ANCOVA|||Change at Week 4 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.00|-1.84|0.548
70856400|NCT00545129|141199464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.75||0.318|TWO_SIDED|95.0|-2.33|0.79|||ANCOVA|||Change at Week 6 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.79|-2.33|0.318
70856401|NCT00545129|141199464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.73||0.484|TWO_SIDED|95.0|-2.02|0.99|||ANCOVA|||Change at Week 8 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.99|-2.02|0.484
70856402|NCT00545129|141199465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.399|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 1: P-value was calculated by Cochran-Mantel-Haenszel (CMH test) stratified by center.||||0.399
70856403|NCT00545129|141199465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.779|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: P-value was calculated by CMH test stratified by center.||||0.779
70856404|NCT00545129|141199465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.922|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: P-value was calculated by CMH test stratified by center.||||0.922
70856405|NCT00545129|141199465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.811|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 6: P-value was calculated by CMH test stratified by center.||||0.811
70856406|NCT00545129|141199465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.237|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: P-value was calculated by CMH test stratified by center.||||0.237
70856407|NCT00545129|141199466|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.22||0.108|TWO_SIDED|95.0|-0.82|0.09|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.09|-0.82|0.108
70856408|NCT00545129|141199466|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.21||0.202|TWO_SIDED|95.0|-0.7|0.16|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.16|-0.70|0.202
70856409|NCT00545129|141199466|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.2||0.571|TWO_SIDED|95.0|-0.54|0.3|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.30|-0.54|0.571
70856410|NCT00545129|141199466|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.24||0.808|TWO_SIDED|95.0|-0.55|0.43|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.43|-0.55|0.808
70856411|NCT00545129|141199466|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.26||0.913|TWO_SIDED|95.0|-0.57|0.51|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.51|-0.57|0.913
70856412|NCT00545129|141199467|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.22||0.108|TWO_SIDED|95.0|-0.82|0.09|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.09|-0.82|0.108
70856413|NCT00545129|141199467|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.21||0.339|TWO_SIDED|95.0|-0.65|0.23|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.23|-0.65|0.339
70944712|NCT00526097|141389832|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.19|||<|0.0001||95.0|0.09|0.41|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||0.41|0.09|<0.0001
70944713|NCT00526097|141389833|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.24||||0.2524||95.0|0.02|2.67|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||2.67|0.02|0.2524
71084889|NCT04556760|141675513|OTHER||Mean Difference (Final Values)|-1.5015|||<|0.001|TWO_SIDED|95.0|-2.2258|-0.7773|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg \[00 to 24 h\])||-0.7773|-2.2258|<0.001
71084890|NCT04556760|141675513|OTHER||Mean Difference (Final Values)|-1.8643|||<|0.001||95.0|-2.5611|-1.1674|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg \[24 to 48 h\])||-1.1674|-2.5611|<0.001
71084891|NCT04556760|141675513|OTHER||Mean Difference (Final Values)|-1.5998|||<|0.001|TWO_SIDED|95.0|-2.3025|-0.8971|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg \[48 to 72 h\])||-0.8971|-2.3025|<0.001
71084892|NCT04556760|141675513|OTHER||Mean Difference (Final Values)|-0.8474||||0.013|TWO_SIDED|95.0|-1.4465|-0.2484|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg \[00 to 24 h\])||-0.2484|-1.4465|0.013
71084893|NCT04556760|141675513|OTHER||Mean Difference (Final Values)|-0.7778||||0.061|TWO_SIDED|95.0|-1.6022|0.0466|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg \[24 to 48 h\])||0.0466|-1.6022|0.061
71084894|NCT04556760|141675513|OTHER||Mean Difference (Final Values)|-1.143||||0.003|TWO_SIDED|95.0|-1.7622|-0.5238|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg \[48 to 72 h\])||-0.5238|-1.7622|0.003
71122707|NCT03880838|141750879|SUPERIORITY||Slope|-0.48|STANDARD_ERROR_OF_MEAN|0.62||0.434|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.434
70944714|NCT00526097|141389834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.2||||0.0035||95.0|0.06|0.63|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||0.63|0.06|0.0035
71084895|NCT04556760|141675513|OTHER||Mean Difference (Final Values)|-0.36||||0.125|TWO_SIDED|95.0|-0.8338|0.1138|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5 mg \[00 to 24 h\])||0.1138|-0.8338|0.125
71084896|NCT04556760|141675513|OTHER||Mean Difference (Final Values)|-0.0845||||0.84|TWO_SIDED|95.0|-0.9706|0.8016|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5 mg \[24 to 48 h\])||0.8016|-0.9706|0.840
71084897|NCT04556760|141675513|OTHER||Mean Difference (Final Values)|-0.1298||||0.571|TWO_SIDED|95.0|-0.646|0.3864|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5 mg \[48 to 72 h\])||0.3864|-0.6460|0.571
71122708|NCT03880838|141750879|SUPERIORITY||Slope|-0.74|STANDARD_ERROR_OF_MEAN|0.62||0.228|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.228
71122709|NCT03880838|141750879|SUPERIORITY||Slope|0.26|STANDARD_ERROR_OF_MEAN|0.62||0.674|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.674
70944715|NCT00526097|141389835|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.06||||0.0004||95.0|0.01|0.46|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||0.46|0.01|0.0004
70944716|NCT00526097|141389836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||0.0086||95.0|0.1|0.69|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||0.69|0.10|0.0086
71084898|NCT04556760|141675514|OTHER||Mean Difference (Final Values)|-0.07||||0.753|TWO_SIDED|95.0|-0.55|0.4|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||0.40|-0.55|0.753
71084899|NCT04556760|141675514|OTHER||Mean Difference (Final Values)|-0.04||||0.802|TWO_SIDED|95.0|-0.46|0.37|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||0.37|-0.46|0.802
71084900|NCT04556760|141675514|OTHER||Mean Difference (Final Values)|0.0||||0.985|TWO_SIDED|95.0|-0.37|0.37|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||0.37|-0.37|0.985
71084901|NCT04556760|141675515|OTHER||Mean Difference (Final Values)|20498.7|||<|0.001|TWO_SIDED|95.0|10819.2|30178.2|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||30178.2|10819.2|<0.001
71084902|NCT04556760|141675515|OTHER||Mean Difference (Final Values)|3321.4||||0.659|TWO_SIDED|95.0|-12975.8|19618.6|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||19618.6|-12975.8|0.659
71084903|NCT04556760|141675515|OTHER||Mean Difference (Final Values)|-2698.8||||0.521|TWO_SIDED|95.0|-14849.0|9451.3|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||9451.3|-14849.0|0.521
71084904|NCT04556760|141675516|OTHER||Mean Difference (Final Values)|-1002.5864||||0.003|TWO_SIDED|95.0|-1620.215|-384.9577|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||-384.9577|-1620.2150|0.003
71084905|NCT04556760|141675516|OTHER||Mean Difference (Final Values)|40.9836||||0.865|TWO_SIDED|95.0|-526.6968|608.664|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||608.6640|-526.6968|0.865
71084906|NCT04556760|141675516|OTHER||Mean Difference (Final Values)|101.4137||||0.754|TWO_SIDED|95.0|-628.8097|831.637|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||831.6370|-628.8097|0.754
71084907|NCT04556760|141675517|OTHER||Mean Difference (Final Values)|-1225.905||||0.004|TWO_SIDED|95.0|-2007.2241|-444.5859|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||-444.5859|-2007.2241|0.004
71084908|NCT04556760|141675517|OTHER||Mean Difference (Final Values)|-466.9802||||0.313|TWO_SIDED|95.0|-1521.5088|587.5485|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||587.5485|-1521.5088|0.313
71122710|NCT03880838|141750879|SUPERIORITY||Slope|0.15|STANDARD_ERROR_OF_MEAN|0.61||0.799|TWO_SIDED||||||Regression, Linear|||In this contrast, no nudge conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.799
70856414|NCT00545129|141199467|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.23||0.408|TWO_SIDED|95.0|-0.67|0.28|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.28|-0.67|0.408
70856415|NCT00545129|141199467|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.27||0.686|TWO_SIDED|95.0|-0.67|0.45|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.45|-0.67|0.686
71084909|NCT04556760|141675517|OTHER||Mean Difference (Final Values)|-375.3161||||0.404||95.0|-1433.6265|682.9943|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||682.9943|-1433.6265|0.404
71084910|NCT04556760|141675518|OTHER||Mean Difference (Final Values)|365.6323||||0.608|TWO_SIDED|95.0|-1097.7973|1829.0618|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||1829.0618|-1097.7973|0.608
71084911|NCT04556760|141675518|OTHER||Mean Difference (Final Values)|188.236||||0.897|TWO_SIDED|95.0|-3214.3323|3590.8043|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||3590.8043|-3214.3323|0.897
71084912|NCT04556760|141675518|OTHER||Mean Difference (Final Values)|-1061.4494||||0.381||95.0|-3588.2233|1465.3244|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||1465.3244|-3588.2233|0.381
71084913|NCT04556760|141675519|OTHER||Mean Difference (Final Values)|60.4211|||<|0.001||95.0|29.4904|91.3518|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||91.3518|29.4904|<0.001
71084914|NCT04556760|141675519|OTHER||Mean Difference (Final Values)|26.4529||||0.432||95.0|-44.9414|97.8471|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||97.8471|-44.9414|0.432
71084915|NCT04556760|141675519|OTHER||Mean Difference (Final Values)|-24.0243||||0.282||95.0|-74.0731|26.0245|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||26.0245|-74.0731|0.282
71084916|NCT04556760|141675520|OTHER||Mean Difference (Final Values)|-0.6023||||0.531|TWO_SIDED|95.0|-2.5463|1.3416|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||1.3416|-2.5463|0.531
71084917|NCT04556760|141675520|OTHER||Mean Difference (Final Values)|0.4621||||0.682|TWO_SIDED|95.0|-2.0933|3.0176|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||3.0176|-2.0933|0.682
71084918|NCT04556760|141675521|OTHER||Mean Difference (Final Values)|0.0679||||0.526||95.0|-0.152|0.2866|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||0.2866|-0.1520|0.526
71084919|NCT04556760|141675521|OTHER||Mean Difference (Final Values)|0.0882||||0.569||95.0|-0.2653|0.4416|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg||0.4416|-0.2653|0.569
71084920|NCT04556760|141675521|OTHER||Mean Difference (Final Values)|0.1257||||0.166|TWO_SIDED|95.0|-0.0677|0.3191|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||0.3191|-0.0677|0.166
71084921|NCT04556760|141675522|OTHER||Mean Difference (Final Values)|0.01||||0.226|TWO_SIDED|95.0|-0.0072|0.0271|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||0.0271|-0.0072|0.226
71084922|NCT04556760|141675522|OTHER||Mean Difference (Final Values)|0.0033||||0.619||95.0|-0.0128|0.0195|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||0.0195|-0.0128|0.619
71084923|NCT04556760|141675522|OTHER||Mean Difference (Final Values)|0.0009||||0.917||95.0|-0.0189|0.0207|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||0.0207|-0.0189|0.917
71084924|NCT04556760|141675523|OTHER||Mean Difference (Final Values)|0.0007||||0.357|TWO_SIDED|95.0|-0.0008|0.0022|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||0.0022|-0.0008|0.357
71084925|NCT04556760|141675523|OTHER||Mean Difference (Final Values)|0.0003||||0.676|TWO_SIDED|95.0|-0.0012|0.0017|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||0.0017|-0.0012|0.676
71084926|NCT04556760|141675523|OTHER||Mean Difference (Final Values)|0.0012||||0.096||95.0|-0.0002|0.0026|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||0.0026|-0.0002|0.096
71084927|NCT04556760|141675524|OTHER||Mean Difference (Final Values)|-1.73||||0.646|TWO_SIDED|95.0|-9.4|5.95|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||5.95|-9.40|0.646
71084928|NCT04556760|141675524|OTHER||Mean Difference (Final Values)|-10.97||||0.11||95.0|-25.39|3.44|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||3.44|-25.39|0.110
71084929|NCT04556760|141675524|OTHER||Mean Difference (Final Values)|-0.35||||0.932||95.0|-10.32|9.61|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||9.61|-10.32|0.932
71084930|NCT04556760|141675525|OTHER||Mean Difference (Final Values)|7.6||||0.533|TWO_SIDED|95.0|-17.4|32.7|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||32.7|-17.4|0.533
71084931|NCT04556760|141675525|OTHER||Mean Difference (Final Values)|22.3||||0.311||95.0|-26.7|71.3|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||71.3|-26.7|0.311
71084932|NCT04556760|141675525|OTHER||Mean Difference (Final Values)|31.0||||0.204||95.0|-21.9|83.9|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||83.9|-21.9|0.204
71084933|NCT04556760|141675535|OTHER||Mean Difference (Final Values)|-4.0066||||0.103|TWO_SIDED|95.0|-8.888|0.8748|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||0.8748|-8.8880|0.103
71084934|NCT04556760|141675535|OTHER||Mean Difference (Final Values)|5.7535||||0.005||95.0|2.6034|8.9036|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||8.9036|2.6034|0.005
71084935|NCT04556760|141675535|OTHER||Mean Difference (Final Values)|9.0619||||0.023||95.0|1.674|16.4499|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||16.4499|1.6740|0.023
71084936|NCT02038179|141675545|SUPERIORITY|||||||0.83||||||Intent-to-Treat Analysis using multiple imputation. Imputed Means and Imputed Standard Errors of the Mean.|paired t-test|||||||0.83
71084937|NCT02038179|141675546|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
71084938|NCT02038179|141675547|SUPERIORITY|||||||0.84|||||||paired t-test|||||||0.84
71122711|NCT03880838|141750879|SUPERIORITY||Slope|0.16|STANDARD_ERROR_OF_MEAN|0.61||0.794|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.794
71122712|NCT03880838|141750879|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.61||0.871|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.871
71122713|NCT03880838|141750879|SUPERIORITY||Slope|0.9|STANDARD_ERROR_OF_MEAN|0.62||0.139|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.139
71122714|NCT03880838|141750880|SUPERIORITY||Slope|0.26|STANDARD_ERROR_OF_MEAN|0.29||0.357|TWO_SIDED||||||Regression, Linear|||In this contrast, letter was compared against all other conditions (coded into one category and set as the reference group). The key outcome is the interaction between conditions and time (2019 as the reference group).||||.357
71122715|NCT03880838|141750880|SUPERIORITY||Slope|-0.29|STANDARD_ERROR_OF_MEAN|0.28||0.294|TWO_SIDED||||||Regression, Linear|||In this contrast, no contact control was compared against all other conditions (coded into one category and set as the reference group). The key outcome is the interaction between conditions and time (2019 as the reference group).||||.294
71122716|NCT03880838|141750880|SUPERIORITY||Slope|-0.28|STANDARD_ERROR_OF_MEAN|0.4||0.496|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.496
71122717|NCT03880838|141750880|SUPERIORITY||Slope|-0.14|STANDARD_ERROR_OF_MEAN|0.4||0.722|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.722
71084939|NCT02221648|141675548|SUPERIORITY_OR_OTHER|||||||0.447|||||||Fisher Exact|||||||0.4470
71084940|NCT02221648|141675549|SUPERIORITY_OR_OTHER|||||||0.0293|||||||Fisher Exact|||||||0.0293
71084941|NCT02221648|141675550|SUPERIORITY_OR_OTHER|||||||0.0448|||||||Fisher Exact|||||||0.0448
71084942|NCT02937623|141675553|OTHER||Least square mean difference|-0.44|||<|0.0001||95.0|-0.591|-0.297|||ANCOVA|ANCOVA model: change from baseline in Schiff sensitivity score as response and treatment as factors and baseline Schiff sensitivity score as covariate|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|||-0.297|-0.591|<.0001
71084943|NCT01585246|141675580|OTHER||Maximum Tolerated Dose (MTD)|960.0|||||TWO_SIDED|||||||||The time-to-event continual reassessment method (TITE-CRM) was used The TITE-CRM incorporated a decision rule for the allocation of next participant to a dose of SP based on the current estimate of toxicity. The first men were allocated to lowest dose (320 mg); when no adverse event was reported during 12 weeks, the dose was increased to 640 mg for next men, and then to 960 mg in the absence of advert event.||||
71084944|NCT01246895|141675613|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||||||0.017
71084945|NCT01246895|141675614|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||||||0.026
71084946|NCT01246895|141675615|SUPERIORITY_OR_OTHER|||||||0.474|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||WOMAC subscale - Pain||||0.474
71084947|NCT01246895|141675615|SUPERIORITY_OR_OTHER|||||||0.236|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||WOMAC subscale - Stiffness||||0.236
71084948|NCT01246895|141675615|SUPERIORITY_OR_OTHER|||||||0.326|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||WOMAC subscale - Physical function||||0.326
71084949|NCT01246895|141675616|SUPERIORITY_OR_OTHER|||||||0.01|||||||Physical count|||||||0.01
71084950|NCT01246895|141675617|SUPERIORITY_OR_OTHER|||||||0.478|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||SF-36 v2 Physical component||||0.478
71084951|NCT01246895|141675617|SUPERIORITY_OR_OTHER|||||||0.125|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||SF-36 v2 Mental component||||0.125
71084952|NCT00871234|141675623|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.03||||0.36||95.0|||||Wilcoxon signed-rank|||||||0.36
71084953|NCT01261390|141675704|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.677|STANDARD_ERROR_OF_MEAN|1.652|||TWO_SIDED|95.0|-5.915|0.561|||||Presented average of the treatment effects on 24hr SBP at 6months and 12months: (6mo + 12mo)/ 2; Comparison: ActivePAP Control. Adjusted for randomization factors (CVD; site; sleepstudy type) with subjectspecific slopes and intercepts.|"We conducted a linear mixed effects regression (LMER) to estimate the treatment effect of CPAP on mean 24hour Systolic Blood Pressure (SBP). Timepoint, treatment, and the timepoint\* treatment interaction were included as fixed effects, as were randomization stratification factors. Subject was included as a random effect. Let: y = observed SBP; β = fixed effects; u = random effects; X = known design matrix; Z = vector of subjects~Then our model is:~y = Xβ + Zu + ε"||0.561|-5.915|
71084954|NCT01261390|141675705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|99.0||||0.003|TWO_SIDED||||||Mixed Models Analysis|Adjusted for intervention and study duration (number of nights), and randomization (CVD; site; diagnostic sleep study type; PAP device type).|Estimated value is minutes of use per night.|We performed a mixed effects analysis of the effect of Motivational Enhancement (ME) on nightly CPAP adherence. Our model included every night of data and adjusted for intervention and study duration (number of nights), as well as randomization stratification factors (CVD; site; diagnostic sleepstudy type; PAP device type).||||0.003
71084955|NCT05404711|141675864|OTHER||AUC|0.56|||||TWO_SIDED|95.0|0.18|0.94|||||Area under the receiver operating characteristic curve (AUC) was 0.56 (95% CI 0.18-0.94) for 2-hour postprandial glucose.|||0.94|0.18|
71084956|NCT05404711|141675865|OTHER||AUC|0.56|||||TWO_SIDED|95.0|0.18|0.94|||||Area under the receiver operating characteristic curve (AUC) was 0.56 (95% CI 0.18-0.94) for 2-hour postprandial glucose.|||0.94|0.18|
71084957|NCT05404711|141675866|OTHER||AUC|0.56|||||TWO_SIDED|95.0|0.18|0.94|||||Area under the receiver operating characteristic curve (AUC) was 0.56 (95% CI 0.18-0.94) for 2-hour postprandial glucose.|||0.94|0.18|
70856416|NCT00545129|141199467|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.3||0.493|TWO_SIDED|95.0|-0.81|0.4|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.40|-0.81|0.493
71084958|NCT05404711|141675867|OTHER||AUC|0.56|||||TWO_SIDED|95.0|0.18|0.94|||||Area under the receiver operating characteristic curve (AUC) was 0.56 (95% CI 0.18-0.94) for 2-hour postprandial glucose.|||0.94|0.18|
71084959|NCT05404711|141675868|OTHER||AUC|1.0|||||TWO_SIDED||||||||Area under the receiver operating characteristic curve (AUC) was 1.00 (based on 100% sensitivity) for elevated fasting glucose.|||||
71084960|NCT05404711|141675869|OTHER||AUC|1.0|||||TWO_SIDED||||||||Area under the receiver operating characteristic curve (AUC) was 1.00 (based on 100% sensitivity) for elevated fasting glucose.|||||
71084961|NCT05404711|141675870|OTHER||AUC|1.0|||||TWO_SIDED||||||||Area under the receiver operating characteristic curve (AUC) was 1.00 (based on 100% sensitivity) for elevated fasting glucose.|||||
71084962|NCT05404711|141675871|OTHER||AUC|1.0|||||TWO_SIDED||||||||Area under the receiver operating characteristic curve (AUC) was 1.00 (based on 100% sensitivity) for elevated fasting glucose.|||||
71122718|NCT03880838|141750880|SUPERIORITY||Slope|0.31|STANDARD_ERROR_OF_MEAN|0.4||0.445|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.445
71122719|NCT03880838|141750880|SUPERIORITY||Slope|-0.24|STANDARD_ERROR_OF_MEAN|0.38||0.531|TWO_SIDED||||||Regression, Linear|||In this contrast, no nudge conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.531
71122720|NCT03880838|141750880|SUPERIORITY||Slope|-0.51|STANDARD_ERROR_OF_MEAN|0.38||0.177|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.177
71122721|NCT03880838|141750880|SUPERIORITY||Slope|-0.38|STANDARD_ERROR_OF_MEAN|0.38||0.314|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.314
71122722|NCT03880838|141750880|SUPERIORITY||Slope|0.07|STANDARD_ERROR_OF_MEAN|0.38||0.85|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.850
71122723|NCT03880838|141750880|SUPERIORITY||Slope|0.32|STANDARD_ERROR_OF_MEAN|0.37||0.391|TWO_SIDED||||||Regression, Linear|||In this contrast, no nudge conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.391
71122724|NCT03880838|141750880|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.37||0.906|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.906
71122725|NCT03880838|141750880|SUPERIORITY||Slope|0.18|STANDARD_ERROR_OF_MEAN|0.37||0.635|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.635
71122726|NCT03880838|141750880|SUPERIORITY||Slope|0.63|STANDARD_ERROR_OF_MEAN|0.37||0.093|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||0.093
71122727|NCT02210832|141750908|SUPERIORITY|38.27% vs. 9.09%|||||<|0.001||||||p value is not adjusted for multiple comparisons. A priori threshold for significance was P \< 0.05.|Chi-squared|chi square test statistic = 20.23, df = 1||Hypothesized that women assigned to Best practices plus financial incentives would achieve greater abstinence than women assigned to Best practices only.||||<0.001
71122728|NCT02210832|141750909|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Chi-squared|Used generalized estimating equation utilizing a logistic link function with treatment condition and assessment time adjusting for covariates.||||||<0.05
71122729|NCT02210832|141750909|SUPERIORITY|||||||0.003||||||chi square test statistic = 21.93, df=7|Mixed Models Analysis|Conducted a generalized estimating equation utilizing a logistic link function with treatment condition and assessment time adjusting for covariates.||Trial condition by assessment time interaction||||0.003
71122730|NCT02210832|141750910|SUPERIORITY|||||||0.48||||||chi square test statistic = 9.52, df = 10|Mixed Models Analysis|Conducted a generalized estimating equation utilizing a logistic link function with treatment condition and assessment time adjusting for covariates.||Interaction of trial condition and time||||0.48
71122731|NCT02210832|141750911|SUPERIORITY||||||<|0.0001||||||chi square test statistic = 33.51, df = 2|Mixed Models Analysis|Conducted a generalized estimating equation utilizing a logistic link function with treatment condition and assessment time adjusting for covariates.||Examining main effect of treatment condition.||||<0.0001
71122732|NCT02210832|141750911|SUPERIORITY|||||||0.89||||||chi square test statistic = 5.00, df = 10.|Mixed Models Analysis|||Testing interaction of treatment condition and assessment time||||0.89
71122733|NCT02210832|141750912|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Method was mixed model repeated measures analysis of covariance.||||||<0.001
71122734|NCT02210832|141750913|SUPERIORITY||||||<|0.001||||||F\[7,922\]=3.62|ANCOVA|Repeated measures analysis of covariance was conducted with Bonferroni corrections for post-doc tests and across repeated assessments.||Examine interaction of treatment condition and assessment time.||||<0.001
71122735|NCT02210832|141750913|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Method was mixed model repeated measures analysis of covariance.||||||<0.001
71122736|NCT02210832|141750914|SUPERIORITY|||||||0.009|||||||Mixed Models Analysis|Method was mixed model repeated measures analysis of covariance.||||||0.009
71122737|NCT02210832|141750915|SUPERIORITY|||||||0.01|||||||Regression, Logistic|Method is logistic regression adjusted for covariates.||||||0.01
71122738|NCT02210832|141750916|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
71122739|NCT02210832|141750917|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
71122740|NCT02210832|141750919|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
71084963|NCT05404711|141675872|OTHER|Spearman correlation analysis|Spearman correlation rho|0.18||||0.3|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT fasting glucose and HbA1c.||||0.3
71122741|NCT02210832|141750923|SUPERIORITY|||||||0.006|||||||ANCOVA|All comparisons adjusted for infant gestational age at time of delivery.||||||0.006
71084964|NCT05404711|141675872|OTHER|Spearman correlation analysis|Spearman correlation rho|0.5||||0.005|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT 2-hour glucose and HbA1c.||||0.005
71084965|NCT05404711|141675872|OTHER|Spearman correlation analysis|Spearman correlation rho|0.46||||0.01|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between delta (difference between fasting and postprandial) home-OGTT glucose and HbA1c.||||0.01
71084966|NCT05404711|141675872|OTHER|Spearman correlation analysis|Spearman correlation rho|0.23||||0.2|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT peak glucose and HbA1c.||||0.2
71084967|NCT05404711|141675872|OTHER|Spearman correlation analysis|Spearman correlation rho|0.14||||0.5|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between time of home-OGTT peak glucose and HbA1c.||||0.5
71084968|NCT05404711|141675872|OTHER|Spearman correlation analysis|Spearman correlation rho|0.29||||0.1|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM mean glucose (mg/dL) and HbA1c.||||0.1
71084969|NCT05404711|141675872|OTHER|Spearman correlation analysis|Spearman correlation rho|-0.15||||0.4|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM correlation of variability (CV) and HbA1c.||||0.4
71084970|NCT05404711|141675872|OTHER|Spearman correlation analysis|Spearman correlation rho|-0.06||||0.7|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM standard deviation and HbA1c.||||0.7
71084971|NCT05404711|141675873|OTHER|Spearman correlation analysis|Spearman correlation rho|0.25||||0.2|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT fasting glucose and laboratory-OGTT fasting glucose.||||0.2
71084972|NCT05404711|141675873|OTHER|Spearman correlation analysis|Spearman correlation rho|0.19||||0.3|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT 2-hour glucose and lab-OGTT fasting glucose.||||0.3
71084973|NCT05404711|141675873|OTHER|Spearman correlation analysis|Spearman correlation rho|-0.1||||0.6|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between delta (difference between fasting and postprandial) home-OGTT and lab-OGTT fasting glucose.||||0.6
71084974|NCT05404711|141675873|OTHER|Spearman correlation analysis|Spearman correlation rho|0.19||||0.3|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT peak glucose and lab-OGTT fasting glucose.||||0.3
71084975|NCT05404711|141675873|OTHER|Spearman correlation analysis|Spearman correlation rho|0.09||||0.6|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between time of home-OGTT peak glucose and lab-OGTT fasting glucose.||||0.6
71084976|NCT05404711|141675873|OTHER|Spearman correlation analysis|Spearman correlation rho|0.35||||0.05|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM mean glucose and lab-OGTT fasting glucose.||||0.05
71084977|NCT05404711|141675873|OTHER|Spearman correlation analysis|Spearman correlation rho|-0.18||||0.3|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM coefficient of variability (CV) and lab-OGTT fasting glucose.||||0.3
71084978|NCT05404711|141675873|OTHER|Spearman correlation analysis|Spearman correlation rho|-0.07||||0.7|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM standard deviation (SD) and lab-OGTT fasting glucose.||||0.7
71084979|NCT05404711|141675874|OTHER|Spearman correlation analysis|Spearman correlation rho|0.1||||0.6|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT fasting glucose and lab-OGTT 2-hour glucose.||||0.6
71084980|NCT05404711|141675874|OTHER|Spearman correlation analysis|Spearman correlation rho|0.31||||0.1|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT 2-hour glucose and lab-OGTT 2-hour glucose.||||0.1
71084981|NCT05404711|141675874|OTHER|Spearman correlation analysis|Spearman correlation rho|0.25||||0.2|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between delta (difference between fasting and postprandial) home-OGTT glucose and lab-OGTT 2-hour glucose.||||0.2
71084982|NCT05404711|141675874|OTHER|Spearman correlation analysis|Spearman correlation rho|0.26||||0.2|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT peak glucose and lab-OGTT 2-hour glucose.||||0.2
71084983|NCT05404711|141675874|OTHER|Spearman correlation analysis|Spearman correlation rho|0.27||||0.2|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between time of home-OGTT peak glucose and lab-OGTT 2-hour glucose.||||0.2
71084984|NCT05404711|141675874|OTHER|Spearman correlation analysis|Spearman correlation rho|0.31||||0.08|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM mean glucose and lab-OGTT 2-hour glucose.||||0.08
70856417|NCT00545129|141199468|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.58||||0.724|TWO_SIDED|95.0|0.03|12.27|||Fisher Exact|||Week 1: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||12.27|0.03|0.724
71122742|NCT02080260|141750938|SUPERIORITY||16-week PFS Rate|0.1||||0.824|TWO_SIDED|95.0|0.012|0.317||This p-value is only based on partial enrollment of the study. The study enrollment was stopped early due to futility.|Fisher Exact||Confidence interval estimated using the Clopper Pearson method.|The null hypothesis assumes a median PFS of 6 weeks, corresponding to a 16-week PFS rate of approximately 0.15. A single-stage design will be used to test that the 16-week PFS rate is less than or equal to 0.15. If at least 8 of the 32 subjects are alive and progression free at 16 weeks, the null hypothesis will be rejected. Assuming a one-sided alpha = 0.10 significance level, this will provide at least 90% power to reject the null hypothesis, assuming the true 16-week PFS rate is 0.35.||0.317|0.012|0.824
70856418|NCT00545129|141199468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.947|TWO_SIDED||||||Fisher Exact|||Week 2: P-value was calculated using Fisher Extract method.||||0.947
70856419|NCT00545129|141199468|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.5||||0.634|TWO_SIDED|95.0|0.03|8.71|||Fisher Exact|||Week 4: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||8.71|0.03|0.634
71084985|NCT05404711|141675874|OTHER|Spearman correlation analysis|Spearman correlation rho|0.15||||0.4|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM coefficient of variability (CV) and lab-OGTT 2-hour glucose.||||0.4
71122743|NCT02080260|141750939|OTHER|Estimation only.|Median|6.1|||||TWO_SIDED|95.0|2.9|7.1|||||The Kaplan Meier method was used to estimate the median PFS(in weeks) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||7.1|2.9|
70856420|NCT00545129|141199468|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.03||||0.975|TWO_SIDED|95.0|0.14|7.74|||Fisher Exact|||Week 6: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||7.74|0.14|0.975
71084986|NCT05404711|141675874|OTHER|Spearman correlation analysis|Spearman correlation rho|0.28||||0.1|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM standard deviation (SD) and lab-OGTT 2-hour glucose.||||0.1
71122744|NCT02080260|141750940|OTHER|Estimation only.|Median|9.4|||||TWO_SIDED|95.0|8.1|17.0|||||The Kaplan Meier method was used to estimate the median OS(in weeks) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||17.0|8.1|
71122745|NCT02080260|141750941|OTHER|Estimation only|Overall Response Rate|0.05|||||TWO_SIDED|95.0|0.001|0.249|||||Confidence interval estimated using the Clopper Pearson method.|||0.249|0.001|
70856421|NCT00545129|141199468|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.49||||0.759|TWO_SIDED|95.0|0.12|18.86|||Fisher Exact|||Week 8: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||18.86|0.12|0.759
70856422|NCT00545129|141199469|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.58||||0.724|TWO_SIDED|95.0|0.03|12.27|||Fisher Exact|||Week 1: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||12.27|0.03|0.724
70856423|NCT00545129|141199469|SUPERIORITY_OR_OTHER_LEGACY|||||||0.95|TWO_SIDED||||||Fisher Exact|||Week 2: P-value was calculated using Fisher Extract test.||||0.950
71122746|NCT02080260|141750942|OTHER|Estimation only.|Disease Control Rate|0.3|||||TWO_SIDED|95.0|0.119|0.543|||||Confidence interval estimated using the Clopper Pearson method.|||0.543|0.119|
71122747|NCT00098722|141750963|SUPERIORITY_OR_OTHER||LS mean difference|-1.021|STANDARD_ERROR_OF_MEAN|0.1802|||TWO_SIDED|97.5|-1.426|-0.616||||||The difference between the treatment least square means (LS means) adjusted for randomization strata was presented in addition to 2-sided 97.5% confidence interval (CI) as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.616|-1.426|
71122748|NCT00098722|141750963|SUPERIORITY_OR_OTHER||LS mean difference|-1.042|STANDARD_ERROR_OF_MEAN|0.1786|||TWO_SIDED|97.5|-1.444|-0.64||||||The difference between the treatment LS means adjusted for randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.640|-1.444|
71122749|NCT00098722|141750964|SUPERIORITY_OR_OTHER||LS mean difference|-0.961|STANDARD_ERROR_OF_MEAN|0.1856|||TWO_SIDED|97.5|-1.379|-0.544||||||The difference between the treatment LS means adjusted for randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.544|-1.379|
70856424|NCT00545129|141199469|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.5||||0.634|TWO_SIDED|95.0|0.03|8.71|||Fisher Exact|||Week 4: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||8.71|0.03|0.634
70856425|NCT00545129|141199469|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.03||||0.975|TWO_SIDED|95.0|0.14|7.74|||Fisher Exact|||Week 6: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||7.74|0.14|0.975
71122750|NCT00098722|141750964|SUPERIORITY_OR_OTHER||LS mean difference|-1.109|STANDARD_ERROR_OF_MEAN|0.184|||TWO_SIDED|97.5|-1.523|-0.695||||||The difference between the treatment LS means adjusted for randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.695|-1.523|
70856426|NCT00545129|141199469|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.02||||0.578|TWO_SIDED|95.0|0.17|23.89|||Fisher Exact|||Week 8: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||23.89|0.17|0.578
70856427|NCT01894568|141199482|NON_INFERIORITY_OR_EQUIVALENCE|0.4% is the margin of Non-inferiority|LS Mean Difference|-0.24||||0.005|TWO_SIDED|95.0|-0.41|-0.07|||Mixed Models Analysis|||||-0.07|-0.41|0.005
70856428|NCT04545944|141199500|OTHER||Geometric Least Squares Mean Ratio|192.4|||||TWO_SIDED|90.0|152.8|242.4||||||A linear mixed model with treatment as a fixed effect and participant as a random effect was performed on the natural log-transformed values to assess the effect of vonoprazan on the PK of midazolam.||242.4|152.8|
71084987|NCT00418028|141675875|NON_INFERIORITY_OR_EQUIVALENCE|"If we assume that the non-inferiority level is up to 15% lower (equivalent to a median progression-free time of 3 months), for a one-sided error α=0.05, and 80% power, are necessary 88 patients per group.~Considering an dropout rate of around 10%, the number of patients would be 98 per group."|Hazard Ratio (HR)|1.3||||0.1224|TWO_SIDED|95.0|0.9|1.7|||Log Rank|||||1.7|0.9|0.1224
70944717|NCT00526097|141389837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-1.2|-0.9||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.9|-1.2|<0.0001
70944718|NCT00526097|141389838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-1.2|-0.8||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.8|-1.2|<0.0001
70944719|NCT00526097|141389839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-1.1|-0.8||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.8|-1.1|<0.0001
70944720|NCT00526097|141389840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.9|-0.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.5|-0.9|<0.0001
70944721|NCT00526097|141389841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|2.4|2.9||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||2.9|2.4|<0.0001
70944722|NCT00526097|141389842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|2.1|2.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||2.7|2.1|<0.0001
70944723|NCT00526097|141389843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001||95.0|2.0|2.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||2.5|2.0|<0.0001
70944724|NCT00526097|141389844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001||95.0|1.7|2.3||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||2.3|1.7|<0.0001
70944725|NCT00526097|141389845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.05||0.0002||95.0|-0.3|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.1|-0.3|0.0002
70944726|NCT00526097|141389846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.05||0.0003||95.0|-0.3|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.1|-0.3|0.0003
70944727|NCT00526097|141389847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.06||0.0127||95.0|-0.2|0.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.0|-0.2|0.0127
71084988|NCT00418028|141675876|SUPERIORITY|||||||0.8269|||||||Chi-squared|||||||0.8269
71084989|NCT00418028|141675877|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.5703|TWO_SIDED|95.0|0.67|2.07|||Log Rank|||||2.07|0.67|0.5703
71084990|NCT00418028|141675878|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.4676|TWO_SIDED|95.0|0.83|1.5|||Log Rank|||||1.50|0.83|0.4676
71084991|NCT00418028|141675879|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.5688|TWO_SIDED|95.0|0.66|1.25|||Log Rank|||||1.25|0.66|0.5688
71084992|NCT00418028|141675880|SUPERIORITY|||||||0.4984|||||||Chi-squared|||||||0.4984
71084993|NCT00418028|141675881|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.2556|TWO_SIDED|95.0|0.88|1.63|||Log Rank|||||1.63|0.88|0.2556
71084994|NCT00823134|141675926|OTHER||Mean Difference (Final Values)|2.8|STANDARD_DEVIATION|4.7||0.021|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.021
70944728|NCT00526097|141389848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.06||0.0064||95.0|-0.3|0.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.0|-0.3|0.0064
71084995|NCT00823134|141675927|OTHER|The number of events found per category (PSG and ApneaLink Plus recording) will be compared. Events are Apneas and Hypopneas per hour of sleep, measured as Apnea-Hypopnea-Index (AHI), Apnea-Index (AI), Obstructive AI, Central AI, Hypopnea-Index (HI) and Oxygen Desaturation Index (ODI).|Correlation coefficient (Bland-Altman)|0.75|||||TWO_SIDED|||||||||Per recording, the number of events found per category with PSG and ApneaLink Plus will be compared. As a summary, all PSG values and all ApneaLink Plus values per category will be collected in one graph (Bland-Altmann Plot). The correlation coefficient will be calculated per category. A correlation of \>75% will be seen as threshold for validity.||||
71084996|NCT00078403|141675933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.58||||||P-value is pre-specified 1-sided test that PEG slows liver fibrosis progression. Accrual and follow-up on Arms A and B were halted at interim review for lack of fibrosis progression in Arm B (control arm). P-value is unadjusted for interim analysis.|Exact Wilcoxon rank sum test|||Accrual and follow-up on Arms A and B were halted for futility at the first independent interim review of the primary endpoint conducted on May 2, 2007.||||0.58
71084997|NCT02291029|141675951|SUPERIORITY||Mean Difference (Net)|-0.41||||0.397|TWO_SIDED|95.0|-3.7|2.89||One-sided p-value|Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||2.89|-3.70|0.397
71084998|NCT02291029|141675951|SUPERIORITY||Mean Difference (Net)|-5.21||||0.009|TWO_SIDED|95.0|-9.46|-0.96||One-sided p-value|Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate.||||-0.96|-9.46|0.009
71084999|NCT02291029|141675951|SUPERIORITY||Mean Difference (Net)|2.34||||0.344|TWO_SIDED|95.0|-2.78|7.45||two-sided p-value|Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate.||||7.45|-2.78|0.344
71085000|NCT02291029|141675952|SUPERIORITY||Mean Difference (Net)|-1.09||||0.205|TWO_SIDED|95.0|-2.97|0.8|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||0.80|-2.97|0.205
71085001|NCT02291029|141675952|SUPERIORITY||Mean Difference (Net)|-0.95||||0.188|TWO_SIDED|95.0|-2.41|0.5|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||0.50|-2.41|0.188
71085002|NCT02291029|141675952|SUPERIORITY||Mean Difference (Net)|-0.37||||0.663|TWO_SIDED|95.0|-2.08|1.35|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||1.35|-2.08|0.663
71085003|NCT02291029|141675953|SUPERIORITY||Mean Difference (Net)|-15.26||||0.161|TWO_SIDED|95.0|-37.9|7.38|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||7.38|-37.90|0.161
71085004|NCT02291029|141675953|SUPERIORITY||Mean Difference (Net)|-12.16||||0.017|TWO_SIDED|95.0|-21.94|-2.38|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||-2.38|-21.94|0.017
71085005|NCT02291029|141675954|SUPERIORITY||Mean Difference (Net)|-9.45||||0.456|TWO_SIDED|95.0|-36.2|17.3|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||17.30|-36.20|0.456
71085006|NCT02291029|141675954|SUPERIORITY||Mean Difference (Net)|-8.14||||0.376|TWO_SIDED|95.0|-26.67|10.39|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||10.39|-26.67|0.376
71085007|NCT02291029|141675955|SUPERIORITY||Mean Difference (Net)|-5.5||||0.172|TWO_SIDED|95.0|-13.91|2.91|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||2.91|-13.91|0.172
71085008|NCT02291029|141675955|SUPERIORITY||Mean Difference (Net)|3.83||||0.175|TWO_SIDED|95.0|-1.81|9.48|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||9.48|-1.81|0.175
71085009|NCT02291029|141675956|SUPERIORITY||Mean Difference (Net)|-0.07||||0.986|TWO_SIDED|95.0|-8.49|8.35|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||8.35|-8.49|0.986
70856429|NCT04545944|141199501|OTHER||Geometric Least Squares Mean Ratio|188.9|||||TWO_SIDED|90.0|150.6|236.9||||||A linear mixed model with treatment as a fixed effect and participant as a random effect was performed on the natural log-transformed values to assess the effect of vonoprazan on the PK of midazolam.||236.9|150.6|
70856430|NCT04545944|141199502|OTHER||Geometric Least Squares Mean Ratio|193.4|||||TWO_SIDED|90.0|160.5|233.1||||||A linear mixed model with treatment as a fixed effect and participant as a random effect was performed on the natural log-transformed values to assess the effect of vonoprazan on the PK of midazolam.||233.1|160.5|
70856431|NCT01514370|141199503|OTHER|||||||0.271|||||||Chi-squared|||||||0.271
71085010|NCT02291029|141675956|SUPERIORITY||Mean Difference (Net)|3.83||||0.175|TWO_SIDED|95.0|-1.81|9.48|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||9.48|-1.81|0.175
71085011|NCT02291029|141675957|SUPERIORITY||Mean Difference (Net)|1.34||||0.807|TWO_SIDED|95.0|-10.48|13.15|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||13.15|-10.48|0.807
71085012|NCT02291029|141675957|SUPERIORITY||Mean Difference (Net)|-9.83||||0.074|TWO_SIDED|95.0|-20.66|1.01|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||1.01|-20.66|0.074
71085013|NCT02922153|141675958|SUPERIORITY|||||||0.0223|TWO_SIDED|95.0|||||t-test, 1 sided|One-sided, two-sample t-test.||||||0.0223
71085014|NCT02922153|141675959|SUPERIORITY|||||||0.6259|TWO_SIDED|95.0|||||t-test, 1 sided|One-sided two-sample t-test.||||||0.6259
71085015|NCT02922153|141675959|SUPERIORITY|||||||0.518|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon two-sample test.||||||0.518
71085016|NCT02922153|141675960|SUPERIORITY|||||||0.0201||||||FEV1 one-sided, two-sample t-test|t-test, 1 sided|||||||0.0201
71085017|NCT02922153|141675960|SUPERIORITY|||||||0.06||||||FVC one-sided, two-sample t-test|t-test, 1 sided|||||||0.06
70856432|NCT01551420|141199524|SUPERIORITY|Null hypothesis of no change after home use|Mean Difference (Net)|0.002|STANDARD_DEVIATION|0.68||0.9358|TWO_SIDED|95.0|-0.27|0.28||Two way comparison between scores at baseline and after 9-12 weeks of Prosthetic use. Alpha=0.05|t-test, 2 sided|paired t-tests||||0.28|-0.27|.9358
71085018|NCT02922153|141675960|SUPERIORITY|||||||0.09||||||SVC one-sided, two-sample t-test|t-test, 1 sided|||||||0.09
71085019|NCT02922153|141675961|SUPERIORITY|||||||0.3085||||||72 Hours Post-Op|Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test||||||0.3085
71085020|NCT02922153|141675961|SUPERIORITY|||||||0.8196||||||96 Hours Post-Op|Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test.||||||0.8196
71085021|NCT02922153|141675961|SUPERIORITY|||||||0.7269||||||120 Hours Post-Op|Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test.||||||0.7269
71085022|NCT02922153|141675963|SUPERIORITY|||||||0.4421|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test||Analysis is the time from end of procedure to oral endotracheal extubation||||0.4421
71085023|NCT02922153|141675964|SUPERIORITY|||||||0.4352||||||Total Post-Procedure for Hospital Stay|Wilcoxon (Mann-Whitney)|Wilcoxon Rank-Sum Test||||||0.4352
71085024|NCT02922153|141675965|SUPERIORITY|||||||0.2939||||||ICU Length of Stay|Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test||||||0.2939
71085025|NCT02922153|141675965|SUPERIORITY|||||||0.0998||||||Hospital Length of Stay|Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test||||||0.0998
71085026|NCT02922153|141675966|SUPERIORITY|||||||0.2877|||||||Chi-squared|||48 Hours Post-Op: Patient able to sit up in bed||||0.2877
71085027|NCT02922153|141675966|SUPERIORITY|||||||0.5311|||||||Fisher Exact|||48 Hours Post-Op: Patient able to stand up||||0.5311
71085028|NCT02922153|141675966|SUPERIORITY|||||||0.4908|||||||Fisher Exact|||48 Hours Post-Op: Patient able to walk||||0.4908
71085029|NCT02922153|141675966|SUPERIORITY|||||||0.8621|||||||Fisher Exact|||48 Hours Post-Op: Right Shoulder Flexion Movement||||0.8621
71085030|NCT02922153|141675966|SUPERIORITY|||||||1|||||||Fisher Exact|||48 Hours Post-Op: Left Shoulder Flexion Movement||||1
71085031|NCT02922153|141675966|SUPERIORITY|||||||0.0133|||||||Fisher Exact|||72 Hours Post-Op: Patient able to sit up in bed||||0.0133
71085032|NCT02922153|141675966|SUPERIORITY|||||||0.0037|||||||Fisher Exact|||72 Hours Post-Op: Patient able to stand up||||0.0037
71085033|NCT02922153|141675966|SUPERIORITY|||||||0.1671|||||||Fisher Exact|||72 Hours Post-Op: Patient able to walk||||0.1671
71085034|NCT02922153|141675966|SUPERIORITY|||||||1|||||||Fisher Exact|||72 Hours Post-Op: Right Shoulder Flexion Movement||||1.000
71085035|NCT02922153|141675966|SUPERIORITY|||||||1|||||||Fisher Exact|||72 Hours Post-Op: Left Shoulder Flexion Movement||||1
71085036|NCT02922153|141675966|SUPERIORITY|||||||1|||||||Fisher Exact|||96 Hours Post-Op: Patient able to sit up in bed||||1
71085037|NCT02922153|141675966|SUPERIORITY|||||||0.2757|||||||Fisher Exact|||96 Hours Post-Op: Patient able to stand up||||0.2757
71085038|NCT02922153|141675966|SUPERIORITY|||||||0.9025|||||||Fisher Exact|||96 Hours Post-Op: Patient able to walk||||0.9025
71085039|NCT02922153|141675966|SUPERIORITY|||||||0.7942|||||||Fisher Exact|||96 Hours Post-Op: Right Shoulder Flexion Movement||||0.7942
71085040|NCT02922153|141675966|SUPERIORITY|||||||1|||||||Fisher Exact|||96 Hours Post-Op: Left Shoulder Flexion Movement||||1
71085041|NCT02922153|141675966|SUPERIORITY|||||||0.3492|||||||Fisher Exact|||120 Hours Post-Op: Patient able to sit up in bed||||0.3492
71085042|NCT02922153|141675966|SUPERIORITY|||||||0.2644|||||||Fisher Exact|||120 Hours Post-Op: Patient able to stand up||||0.2644
71085043|NCT02922153|141675966|SUPERIORITY|||||||0.8258|||||||Fisher Exact|||120 Hours Post-Op: Patient able to walk||||0.8258
71085044|NCT02922153|141675966|SUPERIORITY|||||||0.67|||||||Fisher Exact|||120 Hours Post-Op: Right Shoulder Flexion Movement||||0.67
71085045|NCT02922153|141675966|SUPERIORITY|||||||0.5693|||||||Fisher Exact|||120 Hours Post-Op: Left Shoulder Flexion Movement||||0.5693
71085046|NCT02922153|141675966|SUPERIORITY|||||||0.1189|||||||Chi-squared|||Discharge: Patient able to sit up in bed||||0.1189
71085047|NCT02922153|141675966|SUPERIORITY|||||||1|||||||Fisher Exact|||Discharge: Patient able to stand up||||1
71085048|NCT02922153|141675966|SUPERIORITY|||||||0.6992|||||||Fisher Exact|||Discharge: Patient able to walk||||0.6992
71085049|NCT02922153|141675966|SUPERIORITY|||||||0.4429|||||||Fisher Exact|||Discharge: Right Shoulder Flexion Movement||||0.4429
71085050|NCT02922153|141675966|SUPERIORITY|||||||0.4563|||||||Fisher Exact|||Discharge: Left Shoulder Flexion Movement||||0.4563
71085051|NCT03429348|141675967|SUPERIORITY||Mean Difference (Final Values)|1.18||||9e-07|TWO_SIDED||||||t-test, 2 sided|We are comparing the log transformed values.||||||0.0000009
71085052|NCT03429348|141675967|SUPERIORITY||Mean Difference (Final Values)|1.35||||1.8e-05|TWO_SIDED||||||t-test, 2 sided|We are comparing the log transformed values||||||0.000018
71085053|NCT02692586|141675968|SUPERIORITY|To detect an RV/LV ratio change \> 0.12 with a power of 80% at one-sided alpha = 0.025, the necessary sample size was calculated to be ≥ 52, 31, or 21 patients (to detect RV/LV ratio changes of 0.20, 0.225, or 0.25, respectively).|||||<|0.0001|||||||t-test, 1 sided|||||||< 0.0001
70856433|NCT01551420|141199524|SUPERIORITY||Slope|-0.69||||0.08|TWO_SIDED|95.0|-1.47|0.09|||Regression, Linear|||Linear regression of QOL measure at 9-12 weeks, comparing groups by control type, controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||0.09|-1.47|0.08
70856434|NCT01551420|141199525|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_DEVIATION|0.42|<|0.0001|TWO_SIDED|95.0|0.17|0.43|||t-test, 2 sided|The sample for this analyses was 44 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e participants with UEFS data at both time points).||0.43|0.17|<0.0001
70856435|NCT01551420|141199525|SUPERIORITY||Slope|-0.56|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.73|-0.4|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for UEFS at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from UEFS use measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||-0.40|-0.73|<0.0001
70856436|NCT01551420|141199526|SUPERIORITY||Mean Difference (Net)|-0.22|STANDARD_DEVIATION|0.94||0.186|TWO_SIDED|95.0|-0.55|0.11|||t-test, 2 sided|The sample for this analysis was 34 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e participants with TAPES data at both time points).||0.11|-0.55|0.186
70856437|NCT01551420|141199526|SUPERIORITY||Slope|-1.15|STANDARD_ERROR_OF_MEAN|0.44||0.0168|TWO_SIDED|95.0|-2.06|-0.23|||Regression, Linear|The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for TAPES at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from TAPES measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||-0.23|-2.06|0.0168
70856438|NCT01551420|141199527|SUPERIORITY||Mean Difference (Net)|-0.97|STANDARD_DEVIATION|5.61||0.3367|TWO_SIDED|95.0|-2.99|1.05|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with UEFS data at both time points).||1.05|-2.99|0.3367
70856439|NCT01551420|141199527|SUPERIORITY||Slope|-0.72|STANDARD_ERROR_OF_MEAN|1.49||0.6339|TWO_SIDED|95.0|-3.84|2.39|||Regression, Linear|The sample for this analysis was 22 participants with TR or TH amputation level who completed data collection for UEFS at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from AM-ULA measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||2.39|-3.84|0.6339
70856440|NCT01551420|141199528|SUPERIORITY||Mean Difference (Net)|-1.74|STANDARD_DEVIATION|18.8||0.5465|TWO_SIDED|95.0|-7.53|4.05|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data for participants at baseline and completers at End of A (i.e participants with SF-36V Role Physical data at both time points).||4.05|-7.53|0.5465
70856441|NCT01551420|141199528|SUPERIORITY||Mean Difference (Net)|-3.78|STANDARD_DEVIATION|17.37||0.161|TWO_SIDED|95.0|-9.12|1.57|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data for participants at baseline to End of A (with SF-36V Social Functioning data at both time points).||1.57|-9.12|0.1610
71085054|NCT02692586|141675969|SUPERIORITY|The hypothesized composite MAE rate was expected to be about 13%. The necessary sample size to detect a difference from an expected MAE rate of 13% with 80% power was calculated to be 103 patients (with a one-sided p value = 0.05).|||||<|0.0001|||||||t-test, 1 sided|||||||< 0.0001
70856442|NCT01551420|141199528|SUPERIORITY||Mean Difference (Net)|-0.61|STANDARD_DEVIATION|13.9||0.7765|TWO_SIDED|95.0|-4.9|3.68|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data for participants at baseline to End of A (with SF-36V Physical Functioning data at both time points).||3.68|-4.90|0.7765
70856443|NCT01551420|141199528|SUPERIORITY||Slope|-13.35|STANDARD_ERROR_OF_MEAN|6.91||0.0669|TWO_SIDED|95.0|-27.72|1.02|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for SF-36 at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of SF-36V; Role Physical measure at 9-12 weeks, comparing groups by control type, controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||1.02|-27.72|0.0669
70856444|NCT01551420|141199528|SUPERIORITY||Slope|-8.24|STANDARD_ERROR_OF_MEAN|7.1||0.2592|TWO_SIDED|95.0|-23.01|6.54|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for SF-36 at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of SF-36V: Social Functioning measure at 9-12 weeks, comparing groups by control type, controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||6.54|-23.01|0.2592
70856445|NCT01551420|141199528|SUPERIORITY||Slope|-30.23|STANDARD_ERROR_OF_MEAN|6.25|<|0.0001|TWO_SIDED|95.0|-43.23|-17.23|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for SF-36 at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of SF-36V: Physical Functioning measure at 9-12 weeks, comparing groups by control type, controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||-17.23|-43.23|<0.0001
70856446|NCT01551420|141199529|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.17||0.6691|TWO_SIDED|95.0|-0.05|0.07|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Writing data at both time points).||0.07|-0.05|0.6691
70856447|NCT01551420|141199529|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_DEVIATION|0.06||0.0511|TWO_SIDED|95.0|-0.05|0.0|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Page turning data at both time points).||0.00|-0.05|0.0511
70856448|NCT01551420|141199529|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.09||0.5942|TWO_SIDED|95.0|-0.02|0.04|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Lifting Small Items data at both time points).||0.04|-0.02|0.5942
70856449|NCT01551420|141199529|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_DEVIATION|0.08||0.0101|TWO_SIDED|95.0|-0.07|-0.01|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Checkers data at both time points).||-0.01|-0.07|0.0101
71085055|NCT00735709|141675991|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.93|||<|0.001|TWO_SIDED|95.0|-6.99|-2.86||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||All statistical tests were 2-sided with the estimated P-values at the 5% level of significance. To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.05, the testing procedure stopped for all subsequent endpoints.||-2.86|-6.99|<0.001
71085056|NCT00735709|141675991|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.12|||<|0.001|TWO_SIDED|95.0|-6.17|-2.08||Hierarchical testing stopped at SDS total score at Week 8 in the testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-2.08|-6.17|<0.001
71085057|NCT00735709|141675991|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.52|||<|0.001|TWO_SIDED|95.0|-5.57|-1.47||This treatment arm is not in the testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-1.47|-5.57|<0.001
70856450|NCT01551420|141199529|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_DEVIATION|0.09||0.1063|TWO_SIDED|95.0|-0.06|0.01|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Feeding data at both time points).||0.01|-0.06|0.1063
70856451|NCT01551420|141199529|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_DEVIATION|0.12||0.2474|TWO_SIDED|95.0|-0.06|0.01|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Light Cans data at both time points).||0.01|-0.06|0.2474
70856452|NCT01551420|141199529|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_DEVIATION|0.14||0.1604|TWO_SIDED|95.0|-0.09|0.02|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Heavy Cans data at both time points).||0.02|-0.09|0.1604
70944729|NCT00526097|141389849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.9|-0.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.6|-0.9|<0.0001
70944730|NCT00526097|141389850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-1.0|-0.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.6|-1.0|<0.0001
70944731|NCT00526097|141389851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.9|-0.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.5|-0.9|<0.0001
70944732|NCT00526097|141389852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.8|-0.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.5|-0.8|<0.0001
71085058|NCT00735709|141675992|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.54||||0.135|TWO_SIDED|95.0|-3.56|0.48||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.05, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||0.48|-3.56|0.135
71085059|NCT00735709|141675992|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.11||||0.263|TWO_SIDED|95.0|-3.07|0.84|||Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||0.84|-3.07|0.263
71085060|NCT00735709|141675992|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05||||0.963|TWO_SIDED|95.0|-2.03|1.94|||Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||1.94|-2.03|0.963
71085061|NCT00735709|141675993|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.55|||<|0.001|TWO_SIDED|95.0|-0.8|-0.3|||Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-0.30|-0.80|<0.001
71085062|NCT00735709|141675993|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.71|-0.22|||Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-0.22|-0.71|<0.001
71122751|NCT00098722|141750965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.59|||<|0.0001|TWO_SIDED|95.0|2.56|8.23|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (less than \[\<\] 100,000 or greater than or equal to \[\>=\] 100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio greater than (\>) 1 favors maraviroc.||8.23|2.56|<0.0001
70856453|NCT01551420|141199529|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.4208|TWO_SIDED|95.0|-0.12|0.09|||Regression, Linear|The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from JTHFT: Writing measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||0.09|-0.12|0.4208
70944733|NCT00526097|141389853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|-0.2|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.1|-0.2|<0.0001
71085063|NCT00735709|141675993|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.72|-0.23|||Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-0.23|-0.72|<0.001
71085064|NCT00735709|141675994|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.348|||<|0.001|TWO_SIDED|95.0|1.995|5.618|||Regression, Logistic|Regression with explanatory variables for treatment and Baseline HAM-D24 score.|Odds ratio versus placebo.|||5.618|1.995|<0.001
71085065|NCT00735709|141675994|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.739|||<|0.001|TWO_SIDED|95.0|1.631|4.598|||Regression, Logistic|Regression with explanatory variables for treatment and Baseline HAM-D24 score.|Odds ratio versus placebo|||4.598|1.631|<0.001
71085066|NCT00735709|141675994|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.018|||<|0.001|TWO_SIDED|95.0|1.799|5.063|||Regression, Logistic|Regression with explanatory variables for treatment and Baseline HAM-D24 score.|Odds ratio versus placebo|||5.063|1.799|<0.001
71122752|NCT00098722|141750965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.01|||<|0.0001|TWO_SIDED|95.0|3.35|10.78|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||10.78|3.35|<0.0001
71085067|NCT00735709|141675995|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.59||||0.001|TWO_SIDED|95.0|-7.34|-1.84|||Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-1.84|-7.34|0.001
71085068|NCT00735709|141675995|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.47||||0.002|TWO_SIDED|95.0|-7.32|-1.62|||Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-1.62|-7.32|0.002
70944734|NCT00526097|141389854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|-0.3|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.1|-0.3|<0.0001
70944735|NCT00526097|141389855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|-0.2|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.1|-0.2|<0.0001
70944736|NCT00526097|141389856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.0018||95.0|-0.2|0.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.0|-0.2|0.0018
70944737|NCT00526097|141389857|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
71085069|NCT00735709|141675995|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.13||||0.004|TWO_SIDED|95.0|-6.9|-1.37|||Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-1.37|-6.90|0.004
71085070|NCT00735709|141675996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.951||||0.026|TWO_SIDED|95.0|1.082|3.517|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||3.517|1.082|0.026
70944738|NCT00526097|141389858|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
70944739|NCT00526097|141389859|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
70944740|NCT00526097|141389860|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
71085071|NCT00735709|141675996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.056||||0.015|TWO_SIDED|95.0|1.15|3.673|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||3.673|1.150|0.015
71085072|NCT00735709|141675996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.753||||0.062|TWO_SIDED|95.0|0.973|3.158|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||3.158|0.973|0.062
71085073|NCT02492802|141676017|OTHER|||||||0.77|||||||The Wald Type III test|||||||0.77
71122753|NCT00098722|141750965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.03|||<|0.0001|TWO_SIDED|95.0|2.25|7.2|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.20|2.25|<0.0001
71122754|NCT00098722|141750965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.41|||<|0.0001|TWO_SIDED|95.0|2.47|7.85|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.85|2.47|<0.0001
71122755|NCT00098722|141750966|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.69|||<|0.0001|TWO_SIDED|95.0|2.72|8.1|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||8.10|2.72|<0.0001
71122756|NCT00098722|141750966|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.01|||<|0.0001|TWO_SIDED|95.0|2.91|8.62|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||8.62|2.91|<0.0001
71122757|NCT00098722|141750966|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.67|||<|0.0001|TWO_SIDED|95.0|2.13|6.32|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||6.32|2.13|<0.0001
71122758|NCT00098722|141750966|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.64|||<|0.0001|TWO_SIDED|95.0|2.69|8.02|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||8.02|2.69|<0.0001
71122759|NCT00098722|141750967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.58|||<|0.0001|TWO_SIDED|95.0|2.64|7.92|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.92|2.64|<0.0001
71122760|NCT00098722|141750967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.42|||<|0.0001|TWO_SIDED|95.0|3.13|9.39|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||9.39|3.13|<0.0001
71085074|NCT01165307|141676018|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71085075|NCT01165307|141676019|SUPERIORITY_OR_OTHER|||||||0.82|||||||t-test, 2 sided|||Comparison between the groups for the SF-12 Physical Scale.||||0.82
71085076|NCT01165307|141676019|SUPERIORITY_OR_OTHER|||||||0.11|||||||t-test, 2 sided|||Comparison between the groups for the SF-12 mental scale.||||0.11
71085077|NCT01165307|141676020|SUPERIORITY_OR_OTHER|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
71085078|NCT01165307|141676021|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
71085079|NCT01165307|141676022|SUPERIORITY_OR_OTHER|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
71085080|NCT01165307|141676023|SUPERIORITY_OR_OTHER|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.60
71085081|NCT01165307|141676024|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
71085082|NCT01165307|141676028|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
71085083|NCT03150082|141676058|EQUIVALENCE|Bio-equivalence analysis comparing ciprofloxacin test and reference product has been presented.|Percent ratio|96.88|||||TWO_SIDED|90.0|91.13|103.0|||||Percent ratio (GR37547 500 mg/ciprofloxacin 500 mg reference) has been presented.|||103.00|91.13|
71085084|NCT03150082|141676059|EQUIVALENCE|Bio-equivalence analysis comparing ciprofloxacin test and reference product has been presented.|Percent ratio|93.16|||||TWO_SIDED|90.0|86.09|100.82|||||Percent ratio (GR37547 500 mg/ciprofloxacin 500 mg reference) has been presented.|||100.82|86.09|
71085085|NCT03150082|141676060|EQUIVALENCE|Bio-equivalence analysis comparing ciprofloxacin test and reference product has been presented.|Percent ratio|96.96|||||TWO_SIDED|90.0|91.17|103.11|||||Percent ratio (GR37547 500 mg/ciprofloxacin 500 mg reference) has been presented.|||103.11|91.17|
71085086|NCT03150082|141676061|EQUIVALENCE|Bio-equivalence analysis comparing ciprofloxacin test and reference product has been presented.||||||0.3499||||||"P value was analyzed using a nonparametric Wilcoxon signed-rank test."|Wilcoxon signed-rank test|||||||0.3499
71085087|NCT01718483|141676083|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.35|||<|0.001|TWO_SIDED|95.0|-1.7|-1.01|||Mixed Models Repeated Measures Analysis|||||-1.01|-1.70|<0.001
71085088|NCT01718483|141676084|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71085089|NCT01718483|141676085|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71085090|NCT01718483|141676086|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-6.35|||<|0.001|TWO_SIDED|95.0|-7.17|-5.54|||Mixed Models Repeated Measures Analysis|||||-5.54|-7.17|<0.001
71085091|NCT01718483|141676087|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-7.4|||<|0.001|TWO_SIDED|95.0|-8.93|-5.88|||Mixed Models Repeated Measures Analysis|||||-5.88|-8.93|<0.001
71085092|NCT01718483|141676088|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.199|||<|0.001|TWO_SIDED|95.0|-0.31|-0.088|||ANCOVA|||||-0.088|-0.310|<0.001
71085093|NCT01718483|141676089|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.211|||<|0.001|TWO_SIDED|95.0|-0.33|-0.092|||ANCOVA|||||-0.092|-0.330|<0.001
71085094|NCT01718483|141676090|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.02||||0.308|TWO_SIDED|95.0|-0.07|0.02|||ANCOVA|||||0.02|-0.07|0.308
71085095|NCT01718483|141676091|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Cochran-Mantel-Haenszel|||||||<0.001
71085096|NCT01718483|141676092|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.77|||<|0.001|TWO_SIDED|95.0|-2.24|-1.3||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||||-1.30|-2.24|<0.001
71085097|NCT01718483|141676093|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.65|||<|0.001|TWO_SIDED|95.0|0.72|2.57||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Cognitive Restraint of Eating||2.57|0.72|<0.001
71085098|NCT01718483|141676093|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-4.19|||<|0.001|TWO_SIDED|95.0|-4.98|-3.39||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Disinhibition of Eating||-3.39|-4.98|<0.001
71085099|NCT01718483|141676093|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-4.7|||<|0.001|TWO_SIDED|95.0|-5.49|-3.91||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Perceived Hunger||-3.91|-5.49|<0.001
71085100|NCT01718483|141676094|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-10.32|||<|0.001|TWO_SIDED|95.0|-12.43|-8.21||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||||-8.21|-12.43|<0.001
71085101|NCT01718483|141676095|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.31||||0.706|TWO_SIDED|95.0|-1.93|1.31||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|ANCOVA|||||1.31|-1.93|0.706
71085102|NCT04110314|141676111|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|1.0|1.03|||||These results compare the arm receiving a pre-commitment prompt to the arm receiving no pre-commitment prompt.|||1.03|1.00|
71085103|NCT04110314|141676111|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||These results compare the arm receiving a pre-commitment prompt to the arm receiving no pre-commitment prompt.|||1.01|0.99|
71085104|NCT04110314|141676111|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.99|1.03|||||These results compare the arm receiving a pre-commitment prompt to the arm receiving no pre-commitment prompt.|||1.03|0.99|
71085105|NCT04110314|141676111|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|1.0|1.04|||||These results compare the arm receiving a pre-commitment prompt to the arm receiving no pre-commitment prompt.|||1.04|1.00|
71085106|NCT04110314|141676111|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.98|1.01|||||These results compare the arm receiving gain-framed reminders to the arm receiving no reminders.|||1.01|0.98|
71085107|NCT04110314|141676111|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|0.95|0.97|1.02|||||These results compare the arm receiving gain-framed reminders to the arm receiving no reminders.|||1.02|0.97|
71085108|NCT04110314|141676111|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.97|1.01|||||These results compare the arm receiving gain-framed reminders to the arm receiving no reminders.|||1.01|0.97|
71085109|NCT04110314|141676111|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.98|1.05|||||These results compare the arm receiving gain-framed reminders to the arm receiving no reminders.|||1.05|0.98|
71085110|NCT04110314|141676111|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.99|1.02|||||These results compare the arm receiving loss-framed reminders to the arm receiving no reminders.|||1.02|0.99|
71085111|NCT04110314|141676111|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.98|1.02|||||These results compare the arm receiving loss-framed reminders to the arm receiving no reminders.|||1.02|0.98|
71085112|NCT04110314|141676111|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.97|1.02|||||These results compare the arm receiving loss-framed reminders to the arm receiving no reminders.|||1.02|0.97|
71122761|NCT00098722|141750967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.01|||<|0.0001|TWO_SIDED|95.0|2.29|7.0|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.00|2.29|<0.0001
71122762|NCT00098722|141750967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.08|||<|0.0001|TWO_SIDED|95.0|2.91|8.89|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||8.89|2.91|<0.0001
71122763|NCT00098722|141750968|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.55|||<|0.0001|TWO_SIDED|95.0|1.95|6.48|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||6.48|1.95|<0.0001
71085113|NCT04110314|141676111|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|1.0|1.04|||||These results compare the arm receiving loss-framed reminders to the arm receiving no reminders.|||1.04|1.00|
71085114|NCT01004978|141676185|SUPERIORITY|||||||0.4||||||one-sided p-value|Cochran-Mantel-Haenszel|||||||0.4
71085115|NCT01004978|141676186|SUPERIORITY|||||||0.76|||||||Log Rank|||||||0.76
71085116|NCT01711983|141676195|NON_INFERIORITY|Non-inferiority margin based on 1) the lower 95% confidence bound (= 0.82) for estimated 6-month composite Clinical Success for the historical device (219/253=0.866), and 2) a worst-case analysis of 6-month composite Clinical Success for the historical device (0.81, assuming the 18 subjects with missing echo evaluations were failures).|Risk Difference (RD)|-0.0366|||<|0.0001|ONE_SIDED|95.0||0.007||A priori 1-sided alpha = 0.05.|2-sample binomial proportions test||Difference is control - test. Confidence interval is the upper one-sided 95% Wald confidence interval.|"Test null hypothesis of inferiority of test device (test) compared to historical device (control).~H0: Pc - Pt ≥ Δ vs H1: Pc - Pt \< Δ, where Pt and Pc are true proportions of 6-month clinical success for test and control, respectively, and Δ is the non-inferiority margin.~Given Nc = 253, then Nt = 135 test subjects provides 86% power to reject H0 with 95% confidence if Δ = 0.10 and Pc = Pt = 0.866 under H0."||0.007||<0.0001
71085117|NCT01272908|141676251|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.293||||0.253|||||||Regression, Logistic|||ACR20: Week 12 versus (vs) Week 4||||0.253
71122764|NCT00098722|141750968|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.88||||0.0005|TWO_SIDED|95.0|1.59|5.23|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odd ratio \>1 favors maraviroc.||5.23|1.59|0.0005
71122765|NCT00098722|141750968|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.23|||<|0.0001|TWO_SIDED|95.0|2.26|7.92|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.92|2.26|<0.0001
71122766|NCT00098722|141750968|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1|||<|0.0001|TWO_SIDED|95.0|2.2|7.64|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.64|2.20|<0.0001
71122767|NCT00098722|141750970|SUPERIORITY_OR_OTHER||LS mean difference|47.94|STANDARD_ERROR_OF_MEAN|13.383|||TWO_SIDED|95.0|21.64|74.25||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||74.25|21.64|
71085118|NCT01272908|141676251|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.019||||0.005|||||||Regression, Logistic|||ACR20: Week 24 vs Week 4||||0.005
71085119|NCT01272908|141676251|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.552||||0.023|||||||Regression, Logistic|||ACR50: Week 12 vs Week 4||||0.023
71085120|NCT01272908|141676251|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.861||||0.001|||||||Regression, Logistic|||ACR50: Week 24 vs. Week 4||||0.001
70944741|NCT00526097|141389861|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
70944742|NCT00526097|141389862|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
70944743|NCT00526097|141389863|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
70944744|NCT00526097|141389864|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
70944745|NCT00526097|141389865|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
70944746|NCT00526097|141389866|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
70944747|NCT00526097|141389867|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
70944748|NCT00526097|141389868|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
70944749|NCT00526097|141389869|SUPERIORITY_OR_OTHER|||||||0.6773|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||0.6773
71085121|NCT01272908|141676255|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.099||||0.667|||||||Regression, Logistic|||Good vs Moderate vs None: Week 12 vs Week 4||||0.667
71085122|NCT01272908|141676255|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.589|||<|0.001|||||||Regression, Logistic|||Good vs Moderate vs None: Week 24 vs Week 4||||<0.001
70944750|NCT00526097|141389870|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||0.0002
70944751|NCT00526097|141389871|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||0.0001
70944752|NCT00526097|141389872|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||0.0005
71085123|NCT01272908|141676255|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.138||||0.44|||||||Regression, Logistic|||Good/Moderate vs None: Week 12 vs Week 4||||0.440
71122768|NCT00098722|141750970|SUPERIORITY_OR_OTHER||LS mean difference|38.12|STANDARD_ERROR_OF_MEAN|13.313|||TWO_SIDED|95.0|11.96|64.28||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||64.28|11.96|
71122769|NCT00098722|141750970|SUPERIORITY_OR_OTHER||LS mean difference|52.15|STANDARD_ERROR_OF_MEAN|14.803|||TWO_SIDED|95.0|23.06|81.25||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||81.25|23.06|
70944753|NCT00526097|141389873|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Exact p-value|Wilcoxon rank sum test|||||||<0.0001
70944754|NCT00526097|141389874|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Exact p-value|Wilcoxon rank sum test|||||||<0.0001
70944755|NCT00526097|141389875|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Exact p-value|Wilcoxon rank sum test|||||||<0.0001
70944756|NCT00526097|141389876|SUPERIORITY_OR_OTHER|||||||0.0058||||||Exact p-value|Wilcoxon rank sum test|||||||0.0058
70944757|NCT00526097|141389877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|2.01||0.798||95.0|-3.4|4.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.5|-3.4|0.7980
70944758|NCT00526097|141389878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|2.05||0.6129||95.0|-3.0|5.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||5.1|-3.0|0.6129
70944759|NCT00526097|141389879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|2.31||0.3567||95.0|-2.4|6.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||6.7|-2.4|0.3567
70944760|NCT00526097|141389880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|1.34||0.1407||95.0|-0.7|4.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.6|-0.7|0.1407
70944761|NCT00526097|141389881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3|STANDARD_ERROR_OF_MEAN|1.74||0.013||95.0|0.9|7.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||7.7|0.9|0.0130
70944762|NCT00526097|141389882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|2.14||0.5849||95.0|-3.0|5.3||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||5.3|-3.0|0.5849
70944763|NCT00526097|141389883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|1.94||0.7543||95.0|-3.2|4.4||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.4|-3.2|0.7543
71085124|NCT01272908|141676255|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.009||||0.012|||||||Regression, Logistic|||Good/Moderate vs None: Week 24 vs Week 4||||0.012
71085125|NCT01272908|141676257|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Week 4||||<0.001
71085126|NCT01272908|141676257|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Week 12||||<0.001
70944764|NCT00526097|141389884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5|STANDARD_ERROR_OF_MEAN|1.58||0.0273||95.0|0.4|6.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||6.6|0.4|0.0273
70944765|NCT00526097|141389885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.87||0.129||95.0|-0.4|3.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||3.0|-0.4|0.1290
70944766|NCT00526097|141389886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.7||0.378||95.0|-0.8|2.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||2.0|-0.8|0.3780
70944767|NCT00526097|141389887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.6|-0.3||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.3|-0.6|<0.0001
70944768|NCT00526097|141389888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-1.0|-0.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.7|-1.0|<0.0001
70944769|NCT00526097|141389889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.007||95.0|-0.3|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.1|-0.3|0.0070
70944770|NCT00526097|141389890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001||95.0|-1.5|-1.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-1.0|-1.5|<0.0001
70944771|NCT00526097|141389891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.8|-0.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.5|-0.8|<0.0001
71085127|NCT01272908|141676257|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Week 24||||<0.001
71122770|NCT00098722|141750970|SUPERIORITY_OR_OTHER||LS mean difference|58.46|STANDARD_ERROR_OF_MEAN|14.725|||TWO_SIDED|95.0|29.53|87.4||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||87.40|29.53|
71122771|NCT00098722|141750971|SUPERIORITY_OR_OTHER||LS mean difference|218.57|STANDARD_ERROR_OF_MEAN|71.225|||TWO_SIDED|95.0|78.59|358.54||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||358.54|78.59|
70944772|NCT00460564|141389895|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.83|||<|0.001||95.0|-10.567|-3.093|||t-test, 2 sided|||||-3.093|-10.567|<0.001
70944773|NCT00511836|141389917|SUPERIORITY_OR_OTHER||||||<|2e-05|||||||t-test, 1 sided|||Null hypothesis: mean treatment difference=0.||||<0.00002
71085128|NCT01272908|141676257|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Week 36||||<0.001
71085129|NCT01272908|141676257|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Week 48||||<0.001
71085130|NCT01272908|141676259|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed-Rank test|||Baseline vs Week 24||||<0.001
71085131|NCT01272908|141676261|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Baseline vs Week 24||||<0.001
70944774|NCT00511836|141389920|SUPERIORITY_OR_OTHER||||||<|0.013|||||||t-test, 1 sided|||Null hypothesis: mean treatment difference=0||||<0.013
70944775|NCT00511836|141389921|SUPERIORITY_OR_OTHER|||||||0.245|||||||t-test, 1 sided|||Null hypothesis: mean treatment difference=0||||0.245
70944776|NCT01936324|141389922|OTHER|||||||0.0003|||||||ANCOVA|ANCOVA model with terms of treatment, baseline lesion count, and center.||||||0.0003
70944777|NCT01936324|141389923|OTHER|||||||0.0032|||||||ANCOVA|ANCOVA model with terms of treatment, baseline lesion count, and center||||||0.0032
70944778|NCT01936324|141389924|OTHER|||||||0.007|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study center||||||0.0070
71085132|NCT01272908|141676263|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Baseline vs Week 24||||<0.001
71085133|NCT01272908|141676265|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed Rank test|||Baseline vs Week 24||||<0.001
71085134|NCT01272908|141676267|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Baseline vs Week 24||||<0.001
71085135|NCT01272908|141676269|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed Rank test|||Baseline vs Week 24||||<0.001
71085136|NCT01272908|141676271|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed Rank test|||Baseline vs Week 24||||<0.001
71085137|NCT01272908|141676273|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed Rank test|||Baseline vs Week 24||||<0.001
71085138|NCT01272908|141676277|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Baseline vs Week 12||||<0.001
71085139|NCT01272908|141676277|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed Rank test|||Baseline vs Week 24||||<0.001
71085140|NCT03143101|141676280|SUPERIORITY||Mean Difference (Net)|18.1||||0.006|TWO_SIDED|95.0|4.8|30.9||p-value is calculated from the Cochran-Mantel-Haenszel (CMH) test adjusting for the prior influenza vaccination status.|Cochran-Mantel-Haenszel|||||30.9|4.8|0.006
71122772|NCT00098722|141750971|SUPERIORITY_OR_OTHER||LS mean difference|133.22|STANDARD_ERROR_OF_MEAN|70.855|||TWO_SIDED|95.0|-6.03|272.47||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||272.47|-6.03|
71085141|NCT03143101|141676284|SUPERIORITY||Mean Difference (Net)|32.7|||<|0.001|TWO_SIDED|95.0|14.4|47.8||p-value is calculated from the CMH test adjusting for the prior influenza vaccination status.|Cochran-Mantel-Haenszel|||||47.8|14.4|<0.001
71085142|NCT01630135|141676297|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.089|||<|0.001|TWO_SIDED|95.0|-1.41|-0.76|||ANCOVA||The analysis was based on an analysis of covariance (ANCOVA) with a model adjusting for Treatment, Baseline, Age, and Sex.|||-0.76|-1.41|<0.001
71122773|NCT00098722|141750971|SUPERIORITY_OR_OTHER||LS mean difference|136.93|STANDARD_ERROR_OF_MEAN|57.85|||TWO_SIDED|95.0|23.24|250.62||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||250.62|23.24|
71122774|NCT00098722|141750971|SUPERIORITY_OR_OTHER||LS mean difference|140.25|STANDARD_ERROR_OF_MEAN|57.55|||TWO_SIDED|95.0|27.15|253.35||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||253.35|27.15|
71122775|NCT00098722|141750972|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||<|0.0001|TWO_SIDED|95.0|0.29|0.56|||Log Rank|||P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio calculated by fitting a Cox proportional hazards model including treatment group and randomization strata. Hazard ratio \<1 favors maraviroc.||0.56|0.29|<0.0001
71122776|NCT00098722|141750972|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33|||<|0.0001|TWO_SIDED|95.0|0.23|0.46|||Log Rank|||P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio calculated by fitting a Cox proportional hazards model including treatment group and randomization strata. Hazard ratio \<1 favors maraviroc.||0.46|0.23|<0.0001
71085143|NCT03243305|141676314|OTHER||Seven-cycle Pregnancy Percentage|13.65|||||TWO_SIDED|95.0|9.91|17.39|||Kaplan-Meier|||The primary hypothesis to be tested is whether subjects using Amphora vaginal gel have a 7-cycle cumulative pregnancy percentage less than or equal to 21%||17.39|9.91|
71085144|NCT04346199|141676350|OTHER|No formal hypothesis testing for this endpoint.|Hazard Ratio (HR)|0.758|||||TWO_SIDED|95.0|0.323|1.722||P-value not generated.|Regression, Cox|Adjusting for age (\<65 vs \>=65 years) and comorbidities (present vs absent). Ties handled by Efron approach. HR CI using profile likelihood approach.||||1.722|0.323|
71085145|NCT04346199|141676358|OTHER|No formal hypothesis testing for this endpoint.|Hazard Ratio (HR)|0.967||||||95.0|0.69|1.353|||Regression, Cox|Adjusting for age (\<65 vs \>=65 years) and comorbidities (present vs absent). Ties handled by Efron approach. HR CI using profile likelihood approach.||||1.353|0.690|
71122777|NCT00098722|141750973|SUPERIORITY_OR_OTHER||LS mean difference|-0.876|STANDARD_ERROR_OF_MEAN|0.1534|||TWO_SIDED|95.0|-1.177|-0.575||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.575|-1.177|
71122778|NCT00098722|141750973|SUPERIORITY_OR_OTHER||LS mean difference|-0.882|STANDARD_ERROR_OF_MEAN|0.1521|||TWO_SIDED|95.0|-1.181|-0.584||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.584|-1.181|
71122779|NCT00098722|141750973|SUPERIORITY_OR_OTHER||LS mean difference|-0.855|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-1.189|-0.521||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.521|-1.189|
71122780|NCT00098722|141750973|SUPERIORITY_OR_OTHER||LS mean difference|-1.033|STANDARD_ERROR_OF_MEAN|0.1685|||TWO_SIDED|95.0|-1.364|-0.701||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.701|-1.364|
71122781|NCT02351349|141750983|OTHER|paired t test pre compared to post readings||||||0.0143|||||||t-test, 2 sided|||||||0.0143
71122782|NCT02351349|141750984|OTHER|as above||||||0.1416|||||||t-test, 2 sided|||pre and post comparison of time up and go in intervention group||||0.1416
71122783|NCT02351349|141750985|OTHER|||||||0.9013|||||||t-test, 2 sided|||pre and post value comparison with paired t test was carried out||||0.9013
71122784|NCT01610596|141750991|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
71122785|NCT01519674|141750995|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.24||||0.011||95.0|0.06|0.43||No corrections for multiplicity were performed.|Regression, Linear|||"The null-hypothesis (H0) was tested against the alternative hypothesis (HA) in each of the comparisons as given by:~H0: D = 0% against HA: D ≠ 0% D being the mean treatment difference for change from baseline in HbA1c after 24 weeks of treatment between the two treatment group comparisons (BID+Met and BID+Sita+Met)."||0.43|0.06|0.011
71122786|NCT01519674|141750995|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.11||||0.231||95.0|-0.3|0.07|||Regression, Linear|||The null-hypothesis (H0) was tested against the alternative hypothesis (HA) in each of the comparisons as given by: H0: D = 0% against HA: D ≠ 0% D being the mean treatment difference for change from baseline in HbA1c after 24 weeks of treatment between the two treatment group comparisons (BID+Sita+Met and OD+Sita+Met).||0.07|-0.30|0.231
71085146|NCT03066830|141676391|SUPERIORITY||Difference in Least Square (LS) Mean|-0.76|STANDARD_ERROR_OF_MEAN|0.095|<|0.0001|TWO_SIDED|95.0|-0.946|-0.574|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of Metformin use at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||-0.574|-0.946|< 0.0001
71085147|NCT03066830|141676392|SUPERIORITY||Difference in LS Means|-1.608|STANDARD_ERROR_OF_MEAN|0.286|<|0.0001|TWO_SIDED|95.0|-2.1685|-1.0471|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of Metformin use at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline fasting plasma glucose as a covariate.||-1.0471|-2.1685|< 0.0001
71085148|NCT03066830|141676393|SUPERIORITY||Difference in LS Means|-0.82|STANDARD_ERROR_OF_MEAN|1.272||0.5172|TWO_SIDED|95.0|-3.316|1.669|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of Metformin use at screening and country as fixed effects, and baseline SBP as a covariate.||1.669|-3.316|0.5172
71122787|NCT01519674|141750995|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.36|||<|0.001||95.0|-0.54|-0.17|||Regression, Linear|||The null-hypothesis (H0) was tested against the alternative hypothesis (HA) in each of the comparisons as given by: H0: D = 0% against HA: D ≠ 0% D being the mean treatment difference for change from baseline in HbA1c after 24 weeks of treatment between the two treatment group comparisons (BID+Sita+Met and OD+Sita+Met).||-0.17|-0.54|<0.001
70944779|NCT02412111|141389948|SUPERIORITY||Least Square (LS) mean difference|0.3|||=|0.5846|TWO_SIDED|95.0|-0.8|1.4|||Mixed Model for Repeated Measures (MMRM)|||||1.4|-0.8|= 0.5846
71085149|NCT03066830|141676394|SUPERIORITY||Difference in LS Means|-1.02|STANDARD_ERROR_OF_MEAN|0.983||0.2994|TWO_SIDED|95.0|-2.946|0.907|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of Metformin use at screening, randomization strata of mean SBP (\<130, ≥ 30 mmHg) at screening, and country as fixed effects, and baseline SBP as a covariate.||0.907|-2.946|0.2994
71085150|NCT03066830|141676395|SUPERIORITY||Difference in LS Means|-1.41|STANDARD_ERROR_OF_MEAN|0.267|<|0.0001|TWO_SIDED|95.0|-1.932|-0.884|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of Metformin use at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline weight as a covariate.||-0.884|-1.932|< 0.0001
71085151|NCT03066830|141676396|SUPERIORITY||Percentage difference|6.7||||0.0004|TWO_SIDED|95.0|3.03|10.47|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130,≥130 mmHg) at screening, randomization strata of metformin use at the screening. Missing data at Week 26 were assigned a status of non-responder in the analysis.||10.47|3.03|0.0004
71085152|NCT03066830|141676397|SUPERIORITY||Percentage difference|17.4|||<|0.0001|TWO_SIDED|95.0|11.16|23.73|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization strata of Metformin use at screening. Missing data at Week 26 were assigned a status of non-responder in the analysis.||23.73|11.16|< 0.0001
71085153|NCT01871077|141676422|OTHER|||||||0.89|||||||Friedman test|||||||0.890
71085154|NCT01871077|141676423|OTHER|||||||0.078|||||||Wilcoxon (Mann-Whitney)|||||||0.078
71085155|NCT01871077|141676424|OTHER|||||||1|||||||Friedman test|||||||1.000
71085156|NCT01871077|141676425|OTHER|||||||0.497|||||||Wilcoxon (Mann-Whitney)|||||||.497
71085157|NCT04878120|141676452|SUPERIORITY|||||||0.733||||||For interaction between study group and intervention|ANOVA|||"The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. To test the hypothesis that HCL Control with Smart Bolus Calculator reduces exposure to hypoglycemia with respect to Standard HCL Control, a mixed ANOVA was performed with LBGI as outcome measure, study group as between-subject factor, and intervention type as within-subject factor."||||0.733
71085158|NCT04878120|141676453|SUPERIORITY|||||||0.824||||||For interaction between study group and intervention|ANOVA|||The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with percentage of time spent below 70 mg/dL as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.||||0.824
71085159|NCT04878120|141676454|SUPERIORITY|||||||0.402||||||For interaction between study group and intervention|ANOVA|||The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with percentage of time spent in 70-180 mg/dL as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.||||0.402
71122788|NCT01519674|141750996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||0.022||95.0|0.39|0.93|||Regression, Logistic|||||0.93|0.39|0.022
71122789|NCT01519674|141750996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.618||95.0|0.73|1.71|||Regression, Logistic|||||1.71|0.73|0.618
71122790|NCT01519674|141750996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.005||95.0|1.2|2.85|||Regression, Logistic|||||2.85|1.20|0.005
71122791|NCT01519674|141750997|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.02||95.0|0.38|0.92|||Regression, Logistic|||||0.92|0.38|0.020
71122792|NCT01519674|141750997|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.286||95.0|0.81|2.07|||Regression, Logistic|||||2.07|0.81|0.286
70944780|NCT02412111|141389949|SUPERIORITY||Least square mean difference|0.8|||=|0.386|TWO_SIDED|95.0|-1.0|2.6|||Mixed models Repeated Measures (MMRM)|||||2.6|-1.0|= 0.3860
70944781|NCT02412111|141389950|SUPERIORITY||Least square mean difference|2.8|||=|0.1236|TWO_SIDED|95.0|-0.8|6.4|||Mixed models Repeated Measures (MMRM)|||||6.4|-0.8|= 0.1236
70944782|NCT02412111|141389951|SUPERIORITY||Least square mean difference|-5.8|||=|0.0216|TWO_SIDED|95.0|-10.7|-0.9|||Mixed models Repeated Measures (MMRM)|||||-0.9|-10.7|= 0.0216
70944783|NCT04349644|141389964|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent vari- ables.||||||0.016|||||||ANCOVA|Posttest ANCOVA controlling for pretest values.||||||0.016
70944784|NCT04349644|141389964|OTHER|"A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each depen- dent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate.~Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables."||||||0.288|||||||ANCOVA|Follow-up ANCOVA while controlling Pretest.||||||0.288
70944785|NCT04349644|141389965|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables.||||||0.932|||||||ANCOVA|Posttest ANCOVA controlling pretest value for CASS Vocal Expressiveness.||||||0.932
70944786|NCT04349644|141389965|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables.||||||0.221|||||||ANCOVA|Posttest ANCOVA controlling for pretest for CASS Quality of Rapport.||||||0.221
70944787|NCT04349644|141389965|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables.||||||0.873|||||||ANCOVA|Follow-up ANCOVA controlling for pretest Vocal Expressiveness.||||||0.873
70944788|NCT04349644|141389965|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables.||||||0.512|||||||ANCOVA|Follow-up ANCOVA controlling for pretest Quality of Rapport.||||||0.512
70944789|NCT04349644|141389966|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables.||||||0.05|||||||ANCOVA|Posttest ANCOVA controlling for Pretest.||||||0.05
71085160|NCT04878120|141676455|SUPERIORITY|||||||0.3||||||For interaction between study group and intervention|ANOVA|||The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with percentage of time spent above 180 mg/dL as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.||||0.300
71085161|NCT04878120|141676456|SUPERIORITY|||||||0.168||||||For interaction between study arm and intervention|ANOVA|||The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with HBGI as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.||||0.168
71085162|NCT04878120|141676457|SUPERIORITY|||||||0.476||||||For interaction between study group and intervention|ANOVA|||The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with CGM coefficient of variation as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.||||0.476
71085163|NCT04878120|141676458|SUPERIORITY|||||||0.914||||||For interaction between study group and intervention|ANOVA|||The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with total amount of carbohydrate administered as rescue treatments as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.||||0.914
71085164|NCT02864407|141676472|OTHER||||||<|0.0001||||||p-value for difference of Follow-up Week 24 (±2weeks) versus Baseline.|Paired t-test|||||||<0.0001
71085165|NCT02864407|141676473|OTHER||||||<|0.0001||||||p-value for difference of Week 52 (±2 weeks) versus Baseline.|Paired t-test|||||||<0.0001
71085166|NCT02864407|141676474|OTHER||||||<|0.0001||||||p-value for difference of Follow-up Week 24 (±2weeks) versus Baseline.|Paired t-test|||||||<0.0001
71085167|NCT02864407|141676475|OTHER||||||<|0.0001||||||p-value for difference of Follow-up Week 52 (±2weeks) versus Baseline.|Paired t-test|||||||<0.0001
71122793|NCT01519674|141750997|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2|||<|0.001||95.0|1.39|3.47|||Regression, Logistic|||||3.47|1.39|<0.001
70944790|NCT04349644|141389966|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables.||||||0.393|||||||ANCOVA|Follow-up ANCOVA controlling for Pretest.||||||0.393
71085168|NCT02864407|141676476|OTHER||||||<|0.0001|||||||Paired t-test|p-value for difference of Follow-up Week 24 (±2weeks) versus Baseline.||||||<0.0001
71085169|NCT02864407|141676477|OTHER||||||<|0.0001|||||||Paired t-test|p-value for difference of Follow-up Week 52 (±2weeks) versus Baseline.||||||<0.0001
71085170|NCT02864407|141676478|OTHER||||||<|0.0001|||||||Paired t-test|p-value for difference of Follow-up Week 24 (±2weeks) versus Baseline.||||||<0.0001
71085171|NCT02864407|141676479|OTHER||||||<|0.0001|||||||Paired t-test|p-value for difference of Follow-up Week 52 (±2weeks) versus Baseline.||||||<0.0001
71085172|NCT02864407|141676480|OTHER||||||<|0.0001||||||p-value for difference of Week 24 (±2 weeks) versus Baseline.|Paired t-test|||||||<0.0001
71085173|NCT02864407|141676481|OTHER||||||<|0.0001||||||p-value for difference of 52±2 weeks versus Baseline.|Paired t-test|||||||<0.0001
71085174|NCT02864407|141676482|OTHER||||||<|0.0001||||||p-value for difference of Week 24 (±2 weeks) versus Baseline.|Paired t-test|||||||<0.0001
71085175|NCT02864407|141676483|OTHER||||||<|0.0001||||||p-value for difference of Week 52 (±2 weeks) versus Baseline.|Paired t-test|||||||<0.0001
71122794|NCT01519674|141750998|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.13||||0.52||95.0|-0.26|0.52|||Regression, Linear|||||0.52|-0.26|0.520
71085176|NCT02493517|141676519|NON_INFERIORITY|The non-inferiority margin is defined as 0.6 SDS for the upper limit of 95% CI of the LS mean difference of the log-transformed IGF-1 SDS without back-transformation.|Treatment difference|-0.32|||||TWO_SIDED|95.0|-0.74|0.11||||||"The Least Square (LS) Means and 95% Confidence Intervals (CIs) were based on the generalised linear model (GLM) with IGF-1 SDS change from baseline values as dependent variable, with treatment group and previous pituitary surgery as independent factors, and the baseline value of IGF-1 SDS as independent covariate. A log-transformation with base e was applied to the IGF-1 SDS data before analysing.~The treatment difference (lanreotide Autogel - lanreotide PR) is presented."||0.11|-0.74|
71085177|NCT02493517|141676519|NON_INFERIORITY|The non-inferiority margin for the back-transformed LS Mean ratio of IGF-1 SDS of lanreotide Autogel versus lanreotide PR is exp (0.6) = 1.822.|LS Mean ratio|0.73|||||TWO_SIDED|95.0|0.48|1.11||||||"The LS Means and 95% CIs were based on the GLM with IGF-1 SDS change from baseline values as dependent variable, with treatment group and previous pituitary surgery as independent factors, and the baseline value of IGF-1 SDS as independent covariate. A log-transformation with base e was applied to the IGF-1 SDS data before analysing.~The LS Mean ratio (lanreotide Autogel versus lanreotide PR) is presented."||1.11|0.48|
71122795|NCT01519674|141750998|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.05||||0.788||95.0|-0.34|0.45|||Regression, Linear|||||0.45|-0.34|0.788
71122796|NCT01519674|141750998|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.07||||0.708||95.0|-0.46|0.31|||Regression, Linear|||||0.31|-0.46|0.708
71122797|NCT01519674|141750999|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.28||||0.291||95.0|-0.24|0.81|||Regression, Linear|||||0.81|-0.24|0.291
71122798|NCT01519674|141750999|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.88||||0.001||95.0|-1.41|-0.35|||Regression, Linear|||||-0.35|-1.41|0.001
71122799|NCT01519674|141750999|SUPERIORITY_OR_OTHER||Estimated treatment difference|-1.16|||<|0.001||95.0|-1.69|-0.64|||Regression, Linear|||||-0.64|-1.69|<0.001
71085178|NCT02493517|141676520|OTHER||Risk Difference (RD)|6.3|||||TWO_SIDED|95.0|-5.2|17.7||||||The risk difference (lanreotide Autogel - lanreotide PR) in the percentage of normal IGF-1 SDS values at EOST/EW Visit is presented.||17.7|-5.2|
71085179|NCT02493517|141676521|OTHER||Risk Difference (RD)|-1.6|||||TWO_SIDED|95.0|-17.5|14.4||||||The risk difference (lanreotide Autogel - lanreotide PR) in the percentage of GH levels ≤2.5 mcg/L at EOST/EW Visit is presented.||14.4|-17.5|
71085180|NCT02493517|141676522|OTHER||Risk Difference (RD)|1.6|||||TWO_SIDED|95.0|-8.9|12.0||||||The risk difference (lanreotide Autogel - lanreotide PR) in the percentage of GH levels ≤1 mcg/L at EOST/EW Visit is presented.||12.0|-8.9|
71085181|NCT02493517|141676523|OTHER||Risk Difference (RD)|4.7|||||TWO_SIDED|95.0|-3.1|12.5||||||The risk difference (lanreotide Autogel - lanreotide PR) in the percentage subjects with normal IGF-1 levels and who have GH levels \>1 mcg/L and ≤2.5 mcg/L at EOST/EW Visit is presented.||12.5|-3.1|
71122800|NCT01519674|141751000|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.85||||0.005||95.0|0.26|1.45|||Regression, Linear|||||1.45|0.26|0.005
70944791|NCT04349644|141389967|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables||||||0.917|||||||ANCOVA|Posttest ANCOVA controlling for pretest values.||||||0.917
70944792|NCT04349644|141389967|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables||||||0.963|||||||ANCOVA|Follow-up ANCOVA while controlling for pretest.||||||0.963
71085182|NCT02493517|141676524|OTHER||Treatment difference|3.63|STANDARD_DEVIATION|21.6|||TWO_SIDED|95.0|-3.98|11.25||||||Treatment difference (lanreotide Autogel - lanreotide PR) is presented.||11.25|-3.98|
71085183|NCT02493517|141676525|OTHER||Risk Difference (RD)|-5.5|||||TWO_SIDED|95.0|-24.3|13.3||||||Risk difference (lanreotide Autogel - lanreotide PR) in the percentage of subjects with at least 20% reduction in the solid component of tumour volume compared to Baseline is presented.||13.3|-24.3|
71085184|NCT01116921|141676553|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3||||0.006|TWO_SIDED|95.0|0.13|0.7|||Regression, Logistic|||||0.70|0.13|0.006
71085185|NCT03506438|141676561|SUPERIORITY||Mean Difference (Net)|-6.7||||0.018|TWO_SIDED|95.0|-12.2|-1.2|||Mixed Models Analysis|||||-1.2|-12.2|0.018
71085186|NCT03506438|141676562|SUPERIORITY||Mean Difference (Net)|0.3||||0.48|TWO_SIDED|95.0|-0.5|1.1|||Mixed Models Analysis|||||1.1|-0.5|0.48
71085187|NCT03506438|141676563|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.73|TWO_SIDED|95.0|-1.4|1.0|||Mixed Models Analysis|||||1.0|-1.4|0.73
71085188|NCT03506438|141676564|SUPERIORITY||estimated mean difference|0.6||||0.47|TWO_SIDED|95.0|-1.0|2.1|||Mixed Models Analysis|||||2.1|-1.0|0.47
71085189|NCT03506438|141676565|SUPERIORITY||Odds Ratio (OR)|1.8||||0.29|TWO_SIDED|95.0|0.6|5.2|||Regression, Logistic|||||5.2|0.6|0.29
71085190|NCT03506438|141676566|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
71085191|NCT03506438|141676567|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
71085192|NCT03506438|141676568|SUPERIORITY|||||||0.08|||||||Regression, Logistic|||||||0.08
71122801|NCT01519674|141751000|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.52||||0.085||95.0|-0.07|1.12|||Regression, Linear|||||1.12|-0.07|0.085
71122802|NCT01519674|141751000|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.33||||0.275||95.0|-0.92|0.26|||Regression, Linear|||||0.26|-0.92|0.275
71085193|NCT00536510|141676586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.7|STANDARD_ERROR_OF_MEAN|1.96|<|0.001||95.0|-18.6|-10.9||The significance test was 2-tailed with α=0.05|ANOVA|The efficacy analysis was performed using an ANOVA model with factors for treatment, country, gender, and stratum defined by concomitant statin use.||The primary hypothesis of superiority of MK0524A 2 g to placebo in lowering Low Density Lipoprotein Cholesterol (LDL-C) was assessed using the comparison between these 2 groups from the ANOVA model.||-10.9|-18.6|<0.001
71085194|NCT00536510|141676587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.9|STANDARD_ERROR_OF_MEAN|1.68|<|0.001||95.0|12.6|19.2||The significance test was 2-tailed with α=0.05|ANOVA|The efficacy analysis was performed using an ANOVA model with factors for treatment, country, gender, and stratum defined by concomitant statin use.||The secondary hypothesis of superiority of MK0524A 2 g to placebo in lowering High Density Lipoprotein Cholesterol (HDL-C) was assessed using the comparison between these 2 groups from the ANOVA model.||19.2|12.6|<0.001
71085195|NCT02326272|141676596|SUPERIORITY||Odds Ratio (OR)|33.405|||<|0.0001|TWO_SIDED|97.5|9.965|111.983||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose versus (vs) placebo (PBO).|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||111.983|9.965|<0.0001
71085196|NCT02326272|141676596|SUPERIORITY||Estimated difference in responder rate|69.7|||||TWO_SIDED|95.0|57.12|82.36|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||82.36|57.12|
71122803|NCT01519674|141751001|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.12||||0.674||95.0|-0.7|0.45|||Regression, Linear|||||0.45|-0.70|0.674
71122804|NCT01519674|141751001|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.72||||0.015||95.0|0.14|1.3|||Regression, Linear|||||1.30|0.14|0.015
71085197|NCT02326272|141676596|SUPERIORITY||Odds Ratio (OR)|36.212|||<|0.0001|TWO_SIDED|97.5|10.686|122.713||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||122.713|10.686|<0.0001
70944793|NCT01114139|141389979|SUPERIORITY|The 95% confidence interval was calculated using the large sample assumption.|Treatment Difference|75.59|||<|0.0001|TWO_SIDED|95.0|71.15|80.02|||Cochran-Mantel-Haenszel|The p-value is the result of the Cochran-Mantel-Haenszel test, adjusted for Baseline hemoglobin level and underlying condition.|The treatment difference (ferumoxytol - placebo) was expressed as a percentage.|Participants who achieved a ≥2.0 g/dL increase in hemoglobin from Baseline up to Week 5 were analyzed. Statistical comparison was performed for data up to Week 5 only. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information.||80.02|71.15|<0.0001
71085198|NCT02326272|141676596|SUPERIORITY||Estimated difference in responder rate|71.0|||||TWO_SIDED|95.0|58.47|83.43|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||83.43|58.47|
71085199|NCT02326272|141676597|SUPERIORITY||Odds Ratio (OR)|106.225|||<|0.0001|TWO_SIDED|97.5|9.572|1178.843||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||1178.843|9.572|<0.0001
71085200|NCT02326272|141676597|SUPERIORITY||Estimated difference in responder rate|64.8|||||TWO_SIDED|95.0|52.16|77.46|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||77.46|52.16|
71122805|NCT01519674|141751001|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.84||||0.004||95.0|0.27|1.41|||Regression, Linear|||||1.41|0.27|0.004
71122806|NCT01519674|141751002|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.31||||0.08||95.0|-0.04|0.65|||Regression, Linear|||||0.65|-0.04|0.080
71122807|NCT01519674|141751002|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.09||||0.613||95.0|-0.26|0.43|||Regression, Linear|||||0.43|-0.26|0.613
71122808|NCT01519674|141751002|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.22||||0.213||95.0|-0.56|0.13|||Regression, Linear|||||0.13|-0.56|0.213
71122809|NCT01519674|141751005|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.29||||0.8||95.0|-1.97|2.56|||Regression, Linear|||||2.56|-1.97|0.800
71122810|NCT01519674|141751005|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.02||||0.989||95.0|-2.26|2.29|||Regression, Linear|||||2.29|-2.26|0.989
71122811|NCT01519674|141751005|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.28||||0.809||95.0|-2.52|1.97|||Regression, Linear|||||1.97|-2.52|0.809
71122812|NCT01804582|141751038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|||||||Mixed Models Analysis|||An intent to treat analysis was conducted using a linear mixed model to determine if there was any significant difference in change from baseline to 3 months based on time and condition. Data for all participants was included at baseline and 3 months.||||.15
71122813|NCT01804582|141751039|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07||||0.53|TWO_SIDED||||||Mixed Models Analysis||Cohen's d was calculated to measure the estimation parameter.|||||.53
71122814|NCT01804582|141751040|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03||||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||.80
71122815|NCT01804582|141751041|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33|||||||Mixed Models Analysis|||||||.33
71122816|NCT01804582|141751042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21|||||||Wald Chi-Squared|||||||.21
71122817|NCT01804582|141751043|SUPERIORITY_OR_OTHER_LEGACY||Phi|0.19||||0.005|TWO_SIDED||||||Chi-squared|Chi Squared (1, N = 229) = 7.99.||The total n=229 included those on medication at 90 days (119 never filled the prescription or changed to a different med)||||.005
71122818|NCT02699450|141751109|SUPERIORITY||Difference in Least Squares Means|1.4||||0.37|TWO_SIDED|80.0|-0.6|3.4||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline BCVA.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||3.4|-0.6|0.37
71085201|NCT02326272|141676597|SUPERIORITY||Odds Ratio (OR)|133.163|||<|0.0001|TWO_SIDED|97.5|11.904|1489.578||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||1489.578|11.904|<0.0001
71085202|NCT02326272|141676597|SUPERIORITY||Estimated difference in responder rate|69.6|||||TWO_SIDED|95.0|57.48|81.77|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||81.77|57.48|
71122819|NCT02699450|141751109|SUPERIORITY||Difference in Least Squares Means|3.6||||0.03|TWO_SIDED|80.0|1.5|5.6||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline BCVA.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||5.6|1.5|0.03
71122820|NCT02699450|141751110|SUPERIORITY||Difference in Least Squares Means|1.3||||0.63|TWO_SIDED|80.0|-2.3|5.0||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline BCVA.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||5.0|-2.3|0.63
71122821|NCT02699450|141751111|SUPERIORITY||Difference in Least Squares Means|2.3||||0.15|TWO_SIDED|80.0|0.2|4.3||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline BCVA.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||4.3|0.2|0.15
71122822|NCT02699450|141751111|SUPERIORITY||Difference in Least Squares Means|2.9||||0.04|TWO_SIDED|80.0|1.1|4.7||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline BCVA.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||4.7|1.1|0.04
71122823|NCT02699450|141751112|SUPERIORITY||Difference in Least Squares Means|0.8||||0.94|TWO_SIDED|80.0|-11.3|12.8||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||12.8|-11.3|0.94
71085203|NCT02326272|141676598|SUPERIORITY||Odds Ratio (OR)|24.283|||<|0.0001|TWO_SIDED|97.5|4.386|134.432||The p-value for this analysis as used in the fixed sequence testing procedure was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||134.432|4.386|<0.0001
71122824|NCT02699450|141751112|SUPERIORITY||Difference in Least Squares Means|7.3||||0.46|TWO_SIDED|80.0|-5.4|19.9||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||19.9|-5.4|0.46
71122825|NCT02699450|141751113|SUPERIORITY||Difference in Percentage of Participants|6.4||||0.56|TWO_SIDED|80.0|-7.7|20.5||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||20.5|-7.7|0.56
71122826|NCT02699450|141751114|SUPERIORITY||Difference in Least Squares Means|6.6||||0.43|TWO_SIDED|80.0|-4.0|17.2||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||17.2|-4.0|0.43
71122827|NCT02699450|141751114|SUPERIORITY||Difference in Least Squares Means|7.2||||0.34|TWO_SIDED|80.0|-2.6|17.0||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||17.0|-2.6|0.34
71122828|NCT02699450|141751115|SUPERIORITY||Difference in Least Squares Means|9.5||||0.27|TWO_SIDED|80.0|-1.6|20.6||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||20.6|-1.6|0.27
71122829|NCT02699450|141751115|SUPERIORITY||Difference in Least Squares Means|6.8||||0.45|TWO_SIDED|80.0|-4.9|18.5||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||18.5|-4.9|0.45
71122830|NCT02699450|141751116|SUPERIORITY||Difference in Least Squares Means|-0.6||||0.96|TWO_SIDED|80.0|-16.8|15.5||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||15.5|-16.8|0.96
71122831|NCT02699450|141751117|SUPERIORITY||Difference in Least Squares Means|9.9||||0.19|TWO_SIDED|80.0|0.1|19.7||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||19.7|0.1|0.19
71122832|NCT02699450|141751117|SUPERIORITY||Difference in Least Squares Means|4.2||||0.57|TWO_SIDED|80.0|-5.3|13.6||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||13.6|-5.3|0.57
71122833|NCT02699450|141751118|SUPERIORITY||Difference in Least Squares Means|-2.8||||0.64|TWO_SIDED|80.0|-10.5|4.9||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||4.9|-10.5|0.64
71085204|NCT02326272|141676598|SUPERIORITY||Estimated difference in responder rate|48.1|||||TWO_SIDED|95.0|35.04|61.26|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||61.26|35.04|
71085205|NCT02326272|141676598|SUPERIORITY||Odds Ratio (OR)|27.204|||<|0.0001|TWO_SIDED|97.5|4.895|151.198||The p-value for this analysis as used in the fixed sequence testing procedure was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||151.198|4.895|<0.0001
71085206|NCT02326272|141676598|SUPERIORITY||Estimated difference in responder rate|51.0|||||TWO_SIDED|95.0|37.75|64.19|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||64.19|37.75|
71085207|NCT02326272|141676601|SUPERIORITY||Adjusted Mean Treatment Differences|-6.62|||<|0.0001|TWO_SIDED|97.5|-8.88|-4.36||The P-value was obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group, region, prior biologic exposure as factors; Baseline DLQI score as a covariate.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||-4.36|-8.88|<0.0001
71122834|NCT02699450|141751118|SUPERIORITY||Difference in Least Squares Means|-1.8||||0.78|TWO_SIDED|80.0|-9.8|6.2||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||6.2|-9.8|0.78
71122835|NCT02699450|141751119|SUPERIORITY||Difference in Least Squares Means|-2.3||||0.78|TWO_SIDED|80.0|-12.7|8.2||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||8.2|-12.7|0.78
71085208|NCT02326272|141676601|SUPERIORITY||Adjusted Mean Treatment Differences|-6.19|||<|0.0001|TWO_SIDED|97.5|-8.46|-3.93||The P-value was obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group, region, prior biologic exposure as factors; Baseline DLQI score as a covariate.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||-3.93|-8.46|<0.0001
71085209|NCT00809445|141676623|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|4.52|||<|0.001|TWO_SIDED|97.5|3.57|5.72||a-prior threshold for statistical significance is .025|Cochran-Mantel-Haenszel||The numerator is the two HIV rapid testing arms The denominator is the HIV testing referral arm|Hypothesis: The HIV rapid testing arms would have a higher rate of HIV testing than the HIV testing referral arm. Thus there is one comparison: HIV rapid test \& counseling+HIV rapid test and info versus HIV testing referral.||5.72|3.57|<0.001
71085210|NCT00809445|141676624|SUPERIORITY_OR_OTHER||incidence rate raios (IRR)|1.04||||0.39|TWO_SIDED|97.5|0.95|1.14||a-priori threshold for statistical significance is .025|generalized estimating equations (GEE)||Numerator includes the two HIV rapid testing groups Denominator is the HIV testing referral group|Hypothesis: The HIV rapid testing arms would have a lower rate of unprotected sexual episodes than the HIV testing referral arm. Thus there is one comparison: HIV rapid test \& counseling+HIV rapid test and info versus HIV testing referral.||1.14|0.95|0.39
71122836|NCT02699450|141751120|SUPERIORITY||Difference in Least Squares Means|-0.5||||0.93|TWO_SIDED|80.0|-7.7|6.7||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||6.7|-7.7|0.93
71085211|NCT00809445|141676624|SUPERIORITY_OR_OTHER||Incidence rate ratio (IRR)|1.03||||0.81|TWO_SIDED|97.5|0.84|1.26||a-priori threshold for statistical significance is .025|Generalized estimating equations (GEE)||Numerator is the HIV rapid test and counseling arm Denominator is the HIV rapid test and info arm|"The data analysis information presented is for the comparison of the 2 on-site testing groups.~Hypothesis: HIV rapid test and counseling group will have fewer unprotected sexual acts than will HIV rapid test and info group"||1.26|0.84|0.81
71122837|NCT02699450|141751120|SUPERIORITY||Difference in Least Squares Means|-2.0||||0.69|TWO_SIDED|80.0|-8.3|4.4||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||4.4|-8.3|0.69
71122838|NCT02699450|141751121|SUPERIORITY||Difference in Least Squares Means|-6.5||||0.69|TWO_SIDED|80.0|-27.8|14.7||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline FCPT.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||14.7|-27.8|0.69
71122839|NCT02699450|141751121|SUPERIORITY||Difference in Least Squares Means|-22.8||||0.18|TWO_SIDED|80.0|-44.5|-1.2||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline FCPT.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-1.2|-44.5|0.18
71122840|NCT02699450|141751122|SUPERIORITY||Difference in Least Squares Means|-49.2||||0.07|TWO_SIDED|80.0|-84.2|-14.2||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline FCPT.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||-14.2|-84.2|0.07
71122841|NCT02699450|141751123|SUPERIORITY||Difference in Least Squares Means|-17.3||||0.28|TWO_SIDED|80.0|-38.0|3.4||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline FCPT.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||3.4|-38.0|0.28
71122842|NCT02699450|141751123|SUPERIORITY||Difference in Least Squares Means|-29.2||||0.05|TWO_SIDED|80.0|-47.8|-10.6||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline FCPT.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-10.6|-47.8|0.05
70954308|NCT01253018|141411106|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||"Sample size and power calculations were performed based on the difference in the FM score between the two groups with an assumed within group SD of 15.9, the correlation of 0.5 among repeated measures. 30 subjects enrolled in each arm of the study would give 80% power for detecting a difference of 8 points on the FM.~Two sample t-tests were conducted to compare changes in FM between the two interventions groups at final training (12 week)."||||<0.05
71085212|NCT00809445|141676625|SUPERIORITY_OR_OTHER|||||||0.044||||||a priori threshold for significance was .05|Chi-squared|Note that this is a 3 by 3 chi-square: the 3 conditions by discontinued sharing needles /no change in sharing needles/initiated sharing needles||||||0.044
71122843|NCT02699450|141751124|SUPERIORITY||Difference in Least Squares Means|-12.4||||0.36|TWO_SIDED|80.0|-29.7|5.0||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline CST.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||5.0|-29.7|0.36
71085213|NCT00809445|141676626|SUPERIORITY_OR_OTHER||||||<|0.0001||||||a-priori threshold for statistical significance is .05|Chi-squared|chi-square = 428.2466, Df=2||||||<0.0001
70944794|NCT02705625|141389988|SUPERIORITY|"For the primary endpoint, the Type I error for the tests of the two doses was protected by performing a fixed-sequence multiple-testing procedure in the following order:~Step 1: 200 mg versus placebo Step 2: 100 mg versus placebo The second step was only considered as confirmatory provided the previous step was significant at a one-sided 5%-level (p\<0.05).~If the previous step was not significant, the analysis of the following step was considered descriptive."|Mean Difference (Final Values)|-0.0761||||0.4055|TWO_SIDED|95.0|-0.703|0.55||The p-values reported is from Step 1 (comparing 200 mg versus placebo). The corresponding p-value from Step 2 (comparing 100 mg versus placebo) was 0.1458.|Mixed Models Analysis|||A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment by time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline NRS was included as a covariate for adjustment. An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model.||0.55|-0.703|0.4055
70944795|NCT02705625|141389989|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in knee joint MRI bone area at Week 26.|Mean Difference (Final Values)|-14.7||||0.0036|TWO_SIDED|95.0|-25.3|-4.02||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: bone area increase is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline knee joint MRI bone area was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||-4.02|-25.3|0.0036
70944796|NCT02705625|141389989|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in knee joint MRI bone area at Week 26.|Mean Difference (Final Values)|-15.4||||0.0023|TWO_SIDED|95.0|-26.0|-4.83||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: bone area increase is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline knee joint MRI bone area was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||-4.83|-26|0.0023
70944797|NCT02705625|141389990|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in MRI of cartilage thickness (Femur Region) at Week 26.|Mean Difference (Final Values)|0.0436||||0.1253|TWO_SIDED|95.0|-0.031|0.118||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: MRI of cartilage thinning (Femur Region) is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline MRI of cartilage thickness was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||0.118|-0.031|0.1253
70954309|NCT01253018|141411106|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Two sample t-tests were conducted to compare changes in FM between the two interventions groups at retention (24 weeks).||||<0.05
70954310|NCT01253018|141411108|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Two sample t-tests were conducted to compare changes in WMFT between the two interventions groups at final training 12 week.||||<0.05
70954311|NCT01253018|141411108|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Two sample t-tests were conducted to compare changes in WMFT between the two interventions groups at retention 24 weeks.||||<0.05
71085214|NCT00676403|141676627|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|37.3||||||95.0|0.1|157.7|||ED-50: Bootstrap Method||Non-convergence for the non-liner model occurred in some bootstrap samples which were not included in summarizing the ED50 distribution or confidence interval.|Dose response analysis ED 50: dose providing 50% of the maximal effect. Statistics were obtained from three parameter model Y = D + G\*exp(B\*dose) by bootstrapping 2000 data sets, where D = expected response of saturation (maximal effect), B = related to slope of the dose response mechanism (change in response relative to the change in dose), and D+G = expected response at zero dose.||157.7|0.1|
71085215|NCT00676403|141676627|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|123.9||||||95.0|0.4|523.9|||ED 90: Bootstrap Method||Non-convergence for the non-liner model occurred in some bootstrap samples which were not included in summarizing the ED90 distribution or confidence interval.|Dose response analysis ED 90: dose providing 90% of the maximal effect. Statistics were obtained from three parameter model Y = D + G\*exp(B\*dose) by bootstrapping 2000 data sets, where D = expected response of saturation (maximal effect), B = related to slope of the dose response mechanism (change in response relative to the change in dose), and D+G = expected response at zero dose.||523.9|0.4|
71085216|NCT00676403|141676627|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|2.472||0.0983||95.0|-8.97|0.77|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.77|-8.97|0.0983
71085217|NCT00676403|141676627|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.03|STANDARD_ERROR_OF_MEAN|2.415||0.0966||95.0|-8.78|0.73|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.73|-8.78|0.0966
70944798|NCT02705625|141389990|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in MRI of cartilage thickness (Femur Region) at Week 26.|Mean Difference (Final Values)|0.0761||||0.0225|TWO_SIDED|95.0|0.00173|0.15||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: MRI of cartilage thinning (Femur Region) is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline MRI of cartilage thickness was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||0.15|0.00173|0.0225
70944799|NCT02705625|141389991|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in WOMAC Pain score at Week 26.|Mean Difference (Final Values)|-1.77||||0.2887|TWO_SIDED|95.0|-8.02|4.48||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Pain score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time,baseline analgesic user (Yes/No), and random effect for clinical site. Baseline WOMAC Pain score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||4.48|-8.02|0.2887
70944800|NCT02705625|141389991|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in WOMAC Pain score at Week 26.|Mean Difference (Final Values)|-4.55||||0.0753|TWO_SIDED|95.0|-10.8|1.67||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Pain score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic (Yes/No) and random effect for clinical site. Baseline WOMAC Pain score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||1.67|-10.8|0.0753
70944801|NCT02705625|141389992|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in WOMAC difficulty score at Week 26.|Mean Difference (Final Values)|-1.84||||0.2898|TWO_SIDED|95.0|-8.38|4.7||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Difficulty score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic (Yes/No) and random effect for clinical site. Baseline WOMAC Difficulty score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||4.7|-8.38|0.2898
70944802|NCT02705625|141389992|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in WOMAC difficulty score at Week 26.|Mean Difference (Final Values)|-3.78||||0.1262|TWO_SIDED|95.0|-10.3|2.72||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Difficulty score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic (Yes/No) and random effect for clinical site. Baseline WOMAC difficulty score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||2.72|-10.3|0.1262
70944803|NCT02705625|141389993|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in WOMAC stiffness score at Week 26.|Mean Difference (Final Values)|-3.07||||0.2|TWO_SIDED|95.0|-10.2|4.1||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Stiffness score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic (Yes/No) and random effect for clinical site. Baseline WOMAC Stiffness score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||4.1|-10.2|0.2
71085218|NCT00676403|141676627|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.29|STANDARD_ERROR_OF_MEAN|2.548||0.0013||95.0|-13.31|-3.28|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-3.28|-13.31|0.0013
71085219|NCT00676403|141676627|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.16|STANDARD_ERROR_OF_MEAN|2.437||0.0353||95.0|-9.96|-0.36|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.36|-9.96|0.0353
71085220|NCT00676403|141676627|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.53|STANDARD_ERROR_OF_MEAN|2.469||0.0006||95.0|-13.4|-3.67|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-3.67|-13.40|0.0006
71122844|NCT02699450|141751124|SUPERIORITY||Difference in Least Squares Means|-21.1||||0.13|TWO_SIDED|80.0|-38.7|-3.5||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline CST.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-3.5|-38.7|0.13
71122845|NCT02699450|141751125|SUPERIORITY||Difference in Least Squares Means|-38.6||||0.07|TWO_SIDED|80.0|-65.9|-11.3||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline CST.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||-11.3|-65.9|0.07
71122846|NCT02699450|141751126|SUPERIORITY||Difference in Least Squares Means|-20.1||||0.12|TWO_SIDED|80.0|-36.4|-3.8||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline CST.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-3.8|-36.4|0.12
71122847|NCT02699450|141751126|SUPERIORITY||Difference in Least Squares Means|-26.7||||0.02|TWO_SIDED|80.0|-41.3|-12.0||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline CST.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-12.0|-41.3|0.02
71122848|NCT02699450|141751127|SUPERIORITY||Difference in Percentage of Participants|-4.08||||0.4948|TWO_SIDED|80.0|-7.7|-0.46||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Fisher Exact||The difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-0.46|-7.70|0.4948
71122849|NCT02699450|141751127|SUPERIORITY||Difference in Percentage of Participants|-4.08||||0.496|TWO_SIDED|80.0|-7.7|-0.46||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Fisher Exact||The difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-0.46|-7.70|0.4960
70954312|NCT01253018|141411109|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Two sample t-tests were conducted to compare changes in SIS Hand between the two interventions groups at final training week 12.||||<0.05
71122850|NCT02699450|141751128|SUPERIORITY||Difference in Percentage of Participants|-2.8||||1|TWO_SIDED|80.0|-11.08|5.49||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Fisher Exact||The difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||5.49|-11.08|1.0000
70954313|NCT01253018|141411109|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Two sample t-tests were conducted to compare changes in SIS Hand between the two interventions groups at retention week 24.||||<0.05
71085221|NCT00676403|141676628|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8784||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.8784
71085222|NCT00676403|141676628|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6767||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.6767
71085223|NCT00676403|141676628|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8955||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.8955
71085224|NCT00676403|141676628|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9505||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.9505
71085225|NCT00676403|141676628|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0466||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0466
71085226|NCT00676403|141676629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3876||95.0|||||Cochran-Mantel-Haenszel|||Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.3876
71085227|NCT00676403|141676629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7959||95.0|||||Cochran-Mantel-Haenszel|||Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.7959
71085228|NCT00676403|141676629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2032||95.0|||||Cochran-Mantel-Haenszel|||Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.2032
70856454|NCT01551420|141199529|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.03||0.1959|TWO_SIDED|95.0|-0.09|0.02|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from JTHFT: Page Turning measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||0.02|-0.09|0.1959
70856455|NCT01551420|141199529|SUPERIORITY|Linear regression of scores from JTHFT: Lifting Small Items measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.|Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3328|TWO_SIDED|95.0|-0.09|0.03|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|||0.03|-0.09|0.3328
71085229|NCT00676403|141676629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7032||95.0|||||Cochran-Mantel-Haenszel|||Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.7032
71085230|NCT00676403|141676629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0551||95.0|||||Cochran-Mantel-Haenszel|||Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0551
71085231|NCT00676403|141676629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.41||95.0|||||Cochran-Mantel-Haenszel|||Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.4100
70856456|NCT01551420|141199529|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.6585|TWO_SIDED|95.0|-0.05|0.08|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from JTHFT: Checkers measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||0.08|-0.05|0.6585
70954314|NCT05384938|141411157|OTHER|Single group|Median time to response|100.0|||||TWO_SIDED|95.0|65.0|160.0|||||Estimate for Time to Response using Kaplan-Meier method|Estimate for Time to Response (Days)||160.0|65.00|
71085232|NCT00676403|141676629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6524||95.0|||||Cochran-Mantel-Haenszel|||Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.6524
71085233|NCT00676403|141676629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3219||95.0|||||Cochran-Mantel-Haenszel|||Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.3219
71085234|NCT00676403|141676629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3509||95.0|||||Cochran-Mantel-Haenszel|||Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.3509
71085235|NCT00676403|141676629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0053||95.0|||||Cochran-Mantel-Haenszel|||Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0053
70954315|NCT05384938|141411161|OTHER|Parametric Test|||||<|0.0001|||||||paired t-test|||Week 4 (Visit 2)||||<0.0001
71085236|NCT00676403|141676629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9835||95.0|||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.9835
71085237|NCT00676403|141676629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6668||95.0|||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.6668
71085238|NCT00676403|141676629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2823||95.0|||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.2823
71085239|NCT00676403|141676629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5687||95.0|||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.5687
71085240|NCT00676403|141676629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0043||95.0|||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0043
71085241|NCT00676403|141676629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8662||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.8662
71085242|NCT00676403|141676629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3656||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.3656
71085243|NCT00676403|141676629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0806||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0806
70944804|NCT02705625|141389993|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in WOMAC stiffness score at Week 26.|Mean Difference (Final Values)|-4.95||||0.0861|TWO_SIDED|95.0|-12.1|2.17||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Stiffness score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline WOMAC stiffness score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||2.17|-12.1|0.0861
71085244|NCT00676403|141676629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5381||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.5381
71122851|NCT02699450|141751129|SUPERIORITY||Difference in Percentage of Participants|-6.12||||0.5759|TWO_SIDED|80.0|-15.41|3.17||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Fisher Exact||The difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||3.17|-15.41|0.5759
71085245|NCT00676403|141676629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0090
71085246|NCT00676403|141676629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9748||95.0|||||Cochran-Mantel-Haenszel|||Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.9748
71085247|NCT00676403|141676629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3936||95.0|||||Cochran-Mantel-Haenszel|||Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.3936
71085248|NCT00676403|141676629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1563||95.0|||||Cochran-Mantel-Haenszel|||Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.1563
71085249|NCT00676403|141676629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6357||95.0|||||Cochran-Mantel-Haenszel|||Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.6357
70954316|NCT05384938|141411161|OTHER|Parametric Test|||||<|0.0001|||||||paired t-test|||Week 16 (Visit 4)||||<0.0001
71085250|NCT00676403|141676629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0133||95.0|||||Cochran-Mantel-Haenszel|||Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0133
70856457|NCT01551420|141199529|SUPERIORITY|Linear regression of scores from JTHFT: Feeding measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.|Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.03||0.0552|TWO_SIDED|95.0|-0.12|0.0|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|||0.00|-0.12|0.0552
70856458|NCT01551420|141199529|SUPERIORITY||Slope|-0.13|STANDARD_ERROR_OF_MEAN|0.06||0.0319|TWO_SIDED|95.0|-0.25|-0.01|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from JTHFT: Light Cans measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||-0.01|-0.25|0.0319
70856459|NCT01551420|141199529|SUPERIORITY||Slope|-0.14|STANDARD_ERROR_OF_MEAN|0.05||0.0073|TWO_SIDED|95.0|-0.24|-0.04|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from JTHFT: Heavy Cans measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||-0.04|-0.24|0.0073
70856460|NCT01551420|141199530|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_DEVIATION|0.52||0.6529|TWO_SIDED|95.0|-0.24|0.15|||t-test, 2 sided|The sample for this paired t-test was 30 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with UNB: Spontaneity data at both time points).||0.15|-0.24|0.6529
70856461|NCT01551420|141199530|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_DEVIATION|0.64||0.849|TWO_SIDED|95.0|-0.26|0.22|||t-test, 2 sided|The sample for this paired t-test was 30 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with UNB: Skill data at both time points).||0.22|-0.26|0.8490
70856462|NCT01551420|141199530|SUPERIORITY||Slope|0.13|STANDARD_ERROR_OF_MEAN|0.17||0.4589|TWO_SIDED|95.0|-0.22|0.48|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for UNB: Spontaneity at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from UNB: Spontaneity measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||0.48|-0.22|0.4589
70856463|NCT01551420|141199530|SUPERIORITY||Slope|0.07|STANDARD_ERROR_OF_MEAN|0.18||0.711|TWO_SIDED|95.0|-0.31|0.44|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for UNB: Skill at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from UNB: Skill measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||0.44|-0.31|0.7110
70856464|NCT01551420|141199531|SUPERIORITY||Mean Difference (Net)|253.6|STANDARD_DEVIATION|325.2|<|0.0001|TWO_SIDED|95.0|146.7|360.5|||t-test, 2 sided|The sample for this paired t-test was 38 participants.||Pairwise t-test for data for participants at baseline and completers at End of A (i.e participants with T-MAP data at both time points).|Mean difference is the change in scores from Baseline to End of A.|360.5|146.7|<0.0001
70856465|NCT01551420|141199531|SUPERIORITY||Slope|-183.1|STANDARD_ERROR_OF_MEAN|186.9||0.3397|TWO_SIDED|95.0|-574.3|208.2|||Regression, Linear|The sample for this analysis was 22 participants with TR or TH amputation level who completed data collection for T-MAP at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from T-MAP measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||208.2|-574.3|0.3397
70856466|NCT01551420|141199532|SUPERIORITY||Mean Difference (Net)|4.3|STANDARD_DEVIATION|10.01||0.0465|TWO_SIDED|95.0|0.07|8.53|||t-test, 2 sided|The sample for this paired t-test was 24 participants.|Mean difference is the change in scores from Baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with UEFS data at both time points).||8.53|0.07|0.0465
70856467|NCT01551420|141199532|SUPERIORITY||Slope|-2.39|STANDARD_ERROR_OF_MEAN|2.46||0.345|TWO_SIDED|95.0|-7.6|2.82|||Regression, Linear|The sample for this analysis was 19participants with TR or TH amputation level who completed data collection for UEFS at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from UEFS measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||2.82|-7.60|0.3450
70856468|NCT01551420|141199533|SUPERIORITY||Mean Difference (Net)|0.47|STANDARD_DEVIATION|7.54||0.6881|TWO_SIDED|95.0|-1.86|2.79|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from Baseline to End of A.|Pairwise t-test for data for participants at baseline and completers at End of A (i.e participants with CRIS: Extent of Limitations data at both time points).||2.79|-1.86|0.6881
70954317|NCT05384938|141411161|OTHER|Parametric Test|||||<|0.0001|||||||paired t-test|||Week 24 (Visit 5)||||<0.0001
70856469|NCT01551420|141199533|SUPERIORITY||Mean Difference (Net)|-0.72|STANDARD_DEVIATION|13.95||0.7363|TWO_SIDED|95.0|-5.01|3.67|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from Baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with CRIS: Perceived Limitations data at both time points).||3.67|-5.01|0.7363
70856470|NCT01551420|141199533|SUPERIORITY||Mean Difference (Net)|-1.49|STANDARD_DEVIATION|8.12||0.2361|TWO_SIDED|95.0|-3.99|1.01|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from Baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with CRIS: Satisfaction data at both time points).||1.01|-3.99|0.2361
71122852|NCT02699450|141751129|SUPERIORITY||Difference in Percentage of Participants|3.15||||0.7437|TWO_SIDED|80.0|-5.02|11.33||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Fisher Exact||The difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||11.33|-5.02|0.7437
71122853|NCT02699450|141751130|SUPERIORITY||Difference in Percentage of Participants|2.02||||1|TWO_SIDED|80.0|-8.6|12.64||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Fisher Exact||The difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||12.64|-8.60|1.0000
71122854|NCT01344629|141751155|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|100.9||||||90.0|97.7|104.2||No statistical test|ANOVA|||||104.2|97.7|
71122855|NCT01344629|141751156|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|97.2||||||90.0|87.2|108.3||No statistical test|ANOVA|||||108.3|87.2|
71122856|NCT01344629|141751157|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|101.7||||||90.0|98.3|105.2||No statistical test|ANOVA|||||105.2|98.3|
71122857|NCT01344629|141751158|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|110.1||||||90.0|95.8|124.4||No statistical test|ANOVA|||||124.4|95.8|
71122858|NCT01344629|141751159|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|91.4||||||90.0|85.6|97.6||No statistical test|ANOVA|||||97.6|85.6|
71122859|NCT01344629|141751160|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|109.4||||||90.0|102.4|116.8||No statistical test|ANOVA|||||116.8|102.4|
70856471|NCT01551420|141199533|SUPERIORITY||Slope|-7.07|STANDARD_ERROR_OF_MEAN|4.02||0.0932|TWO_SIDED|95.0|-15.43|1.29|||Regression, Linear|The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for CRIS-CAT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from CRIS-CAT: Extent of Limitations measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||1.29|-15.43|0.0932
71122860|NCT01344629|141751161|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|109.0||||||90.0|101.5|117.1||No statistical test|ANOVA|||||117.1|101.5|
70856472|NCT01551420|141199533|SUPERIORITY||Mean Difference (Final Values)|-10.5|STANDARD_ERROR_OF_MEAN|6.0||0.0951|TWO_SIDED|95.0|-22.9|1.99|||Regression, Linear|The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for CRIS-CAT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from CRIS-CAT: Perceived Limitations measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||1.99|-22.9|0.0951
71122861|NCT04063787|141751172|EQUIVALENCE|The null hypothesis is the difference is zero. Thus the equivalence margin equals zero.|Mean Difference (Final Values)|0.408|STANDARD_DEVIATION|1.05||0.012|TWO_SIDED||||||t-test, 2 sided|Paired t-test||Compare before and after use of Fist Assist||||0.012
71122862|NCT05545644|141751176|SUPERIORITY||Hedges g|0.48|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|||||Given the small sample size, we relied more heavily on effect size calculations (Hedges g adjusted for small sample bias).||||||||
71122863|NCT05545644|141751177|SUPERIORITY||Hedges g|0.37|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|||||Given the small sample size, we relied more heavily on effect size calculations (Hedges g adjusted for small sample bias).||||||||
71122864|NCT05545644|141751178|SUPERIORITY||Hedges g|0.04|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|||||Given the small sample size, we relied more heavily on effect size calculations (Hedges g adjusted for small sample bias).||||||||
71122865|NCT05545644|141751178|SUPERIORITY|Given the small sample size, we relied more heavily on effect size calculations (Hedges g adjusted for small sample bias).|Mean Difference (Final Values)|0.19|||||TWO_SIDED||||||||||Hedges g = .04; SE = .42|||
71122866|NCT05545644|141751179|SUPERIORITY||Hedges g|0.44|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|||||Given the small sample size, we relied more heavily on effect size calculations (Hedges g adjusted for small sample bias).||||||||
71085251|NCT00676403|141676630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.6|STANDARD_ERROR_OF_MEAN|8.05||0.4133||95.0|-22.4|9.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.3|-22.4|0.4133
71085252|NCT00676403|141676630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|7.92||0.6676||95.0|-19.0|12.2|||Mixed Models Analysis|||Week 1: Conrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||12.2|-19.0|0.6676
71122867|NCT01511809|141751196|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A lower limit of the 95% confidence interval of the difference between the two proportions of treatment failure (triple therapy-monotherapy) below the pre-specified margin of non-inferiority of -10% established inferiority. A sample size of 342 patients (171 per treatment arm) provided 80% power (one-sided, alpha 0.05) to establish non-inferiority of ATV/r monotherapy as compared to ATV/r triple therapy with an overall treatment failure (TF) rate of 15% at week 48.|difference between TF proportions|15.0|||||TWO_SIDED|||||||||"Here are reported the results of the 48-week interim analyses according to the intention-to-treat (ITT) principle. ITT=F (with re-intensification=failure) and the ITT=S (with re-intensification=success) treatment failure results are shown.~Based on the efficacy data review, in June 2013, an independent Data and Safety Monitoring Board (DSMB) recommended to stop further patients' enrolment and to follow-up the enrolled patients until 96 weeks, after having signed an updated informed consent."||||
71122868|NCT02945553|141751207|OTHER|Mixed model analysis of variance|Mean Difference (Final Values)|1596.0|STANDARD_DEVIATION|202.0|<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
71122869|NCT02945553|141751212|OTHER||Mean Difference (Net)|30.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71122870|NCT03343080|141751228|SUPERIORITY|||||||0.776|||||||Wilcoxon (Mann-Whitney)|||||||0.776
71122871|NCT03343080|141751229|SUPERIORITY|||||||0.296|||||||t-test, 2 sided|||4 hours post-extubation||||0.296
71122872|NCT01241760|141751230|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% confidence interval of the difference in proportions was above the pre-determined non-inferiority margin of -11%, non-inferiority was established.|Difference in proportion of response, %|1.5||||||95.0|-4.9|12.0|||Regression, Logistic|The 95% confidence interval of the difference in proportions was estimated using a logistic regression model.|Observed data|||12|-4.9|
71122873|NCT03689244|141751237|SUPERIORITY||Ratio of Geometric LS mean|0.95||||0.412|TWO_SIDED|95.0|0.84|1.07|||ANCOVA|||Ratio of Geometric mean of Selexipag to Placebo was reported.||1.07|0.84|0.412
71122874|NCT02138240|141751243|OTHER|Pre-post comparison|||||<|0.001|||||||Wilcoxon signed rank sum|||||||<0.001
71122875|NCT02138240|141751246|OTHER|Pre-post comparison of baseline median weight to median weight at 6-month follow up||||||0.21|||||||Wilcoxon signed rank sum|||||||0.21
71122876|NCT00969436|141751254|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for measles 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the two-sided standardised asymptotic 95% CI on the difference in the seroconversion rates between the two groups (Priorix-Tetra Group minus Control Group) was greater than or equal to (≥) -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.52|5.09||||||Non-inferiority of 2 doses of Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-measles seroconversion rates.||5.09|-2.52|
71122877|NCT00969436|141751254|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for mumps 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the two-sided standardised asymptotic 95% CI on the difference in the seroconversion rates between the two groups (Priorix-Tetra Group minus Control Group) was greater than or equal to (≥) -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.52|5.09||||||Non-inferiority of 2 doses of Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-mumps seroconversion rates.||5.09|-2.52|
71122878|NCT00969436|141751254|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for rubella 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the two-sided standardised asymptotic 95% CI on the difference in the seroconversion rates between the two groups (Priorix-Tetra Group minus Control Group) was greater than or equal to (≥) -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.51|5.02||||||Non-inferiority of 2 doses of Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-rubella seroconversion rates.||5.02|-2.51|
71122879|NCT00969436|141751254|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for varicella 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the two-sided standardised asymptotic 95% CI on the difference in the seroconversion rates between the two groups (Priorix-Tetra Group minus Control Group) was greater than or equal to (≥) -10%.|Difference in percentage|4.17|||||TWO_SIDED|95.0|1.37|11.57||||||Non-inferiority of 2 doses of Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-varicella seroconversion rates.||11.57|1.37|
71122880|NCT00969436|141751254|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for measles 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) on the difference in the seroconversion rates between the 2 groups (Priorix/Priorix-Tetra Group minus Control Group) was ≥ -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.46|5.09||||||Non-inferiority of Priorix™ vaccine followed by Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-measles seroconversion rates.||5.09|-2.46|
71085253|NCT00676403|141676630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|8.04||0.9355||95.0|-16.5|15.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||15.2|-16.5|0.9355
71085254|NCT00676403|141676630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|7.97||0.9355||95.0|-15.1|16.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.4|-15.1|0.9355
71085255|NCT00676403|141676630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.5|STANDARD_ERROR_OF_MEAN|7.94||0.1895||95.0|-26.1|5.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.2|-26.1|0.1895
71085256|NCT00676403|141676630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.9|STANDARD_ERROR_OF_MEAN|8.1||0.1443||95.0|-27.8|4.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.1|-27.8|0.1443
71085257|NCT00676403|141676630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.4|STANDARD_ERROR_OF_MEAN|7.96||0.2946||95.0|-24.0|7.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.3|-24.0|0.2946
71085258|NCT00676403|141676630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.4|STANDARD_ERROR_OF_MEAN|8.22||0.3686||95.0|-23.6|8.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.8|-23.6|0.3686
71085259|NCT00676403|141676630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|8.02||0.6079||95.0|-19.9|11.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.7|-19.9|0.6079
71085260|NCT00676403|141676630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-25.5|STANDARD_ERROR_OF_MEAN|7.99||0.0016||95.0|-41.2|-9.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-9.7|-41.2|0.0016
71085261|NCT00676403|141676630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|8.22||0.5976||95.0|-20.5|11.8|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.8|-20.5|0.5976
71085262|NCT00676403|141676630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|8.0||0.8527||95.0|-14.3|17.3|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||17.3|-14.3|0.8527
71122881|NCT00969436|141751254|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for mumps 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) on the difference in the seroconversion rates between the 2 groups (Priorix/Priorix-Tetra Group minus Control Group) was ≥ -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.48|5.09||||||Non-inferiority of Priorix™ vaccine followed by Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-mumps seroconversion rates.||5.09|-2.48|
71122882|NCT00969436|141751254|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for rubella 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) on the difference in the seroconversion rates between the 2 groups (Priorix/Priorix-Tetra Group minus Control Group) was ≥ -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.48|5.02||||||Non-inferiority of Priorix™ vaccine followed by Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-rubella seroconversion rates.||5.02|-2.48|
71122883|NCT00969436|141751254|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for varicella 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) on the difference in the seroconversion rates between the 2 groups (Priorix/Priorix-Tetra Group minus Control Group) was ≥ -10%.|Difference in percentage|2.77|||||TWO_SIDED|95.0|-1.59|10.29||||||Non-inferiority of Priorix™ vaccine followed by Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-varicella seroconversion rates.||10.29|-1.59|
71122884|NCT02789410|141751275|SUPERIORITY|||||||0.132|||||||Wilcoxon (Mann-Whitney)|||||||0.132
71085263|NCT00676403|141676630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|8.29||0.6973||95.0|-19.6|13.1|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.1|-19.6|0.6973
71085264|NCT00676403|141676630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|8.09||0.6895||95.0|-19.2|12.7|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||12.7|-19.2|0.6895
71085265|NCT00676403|141676630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.1|STANDARD_ERROR_OF_MEAN|8.21||0.0209||95.0|-35.2|-2.9|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-2.9|-35.2|0.0209
71085266|NCT00676403|141676630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.8|STANDARD_ERROR_OF_MEAN|8.18||0.4084||95.0|-22.9|9.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.3|-22.9|0.4084
71085267|NCT00676403|141676630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.8|STANDARD_ERROR_OF_MEAN|7.96||0.3958||95.0|-22.5|8.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.9|-22.5|0.3958
71085268|NCT00676403|141676630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|8.25||0.5776||95.0|-20.9|11.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.7|-20.9|0.5776
71085269|NCT00676403|141676630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|8.06||0.5665||95.0|-20.5|11.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.3|-20.5|0.5665
71085270|NCT00676403|141676630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-23.5|STANDARD_ERROR_OF_MEAN|8.13||0.0041||95.0|-39.6|-7.5|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-7.5|-39.6|0.0041
71085271|NCT00676403|141676630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.9|STANDARD_ERROR_OF_MEAN|8.22||0.1842||95.0|-27.1|5.2|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.2|-27.1|0.1842
71122885|NCT02789410|141751276|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||||||0.590
71122886|NCT02789410|141751277|SUPERIORITY|||||||0.971|||||||Wilcoxon (Mann-Whitney)|||||||0.971
71122887|NCT03159104|141751286|SUPERIORITY||Median Difference (Final Values)|5.0||||0.0113|TWO_SIDED|95.0|1.0|9.0|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimator was used for the difference between median change of total scholastic skill score in each comparison group.|The difference between final and initial total scholastic skill score was calculated for each participant. Wilcoxon test was used for comparison of these differences because data distribution differs from normal.||9|1|0.0113
71122888|NCT03159104|141751287|SUPERIORITY||Median Difference (Final Values)|0.0||||0.0608|TWO_SIDED|95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimator was used for the difference between median change of total scholastic skill score in each comparison group.|||5|0|0.0608
71122889|NCT03159104|141751288|SUPERIORITY||Median Difference (Final Values)|0.0||||0.0824|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimator was used for the difference between median change of total scholastic skill score in each comparison group.|||0|0|0.0824
71122890|NCT03159104|141751289|SUPERIORITY||Median Difference (Final Values)|0.0||||0.2391|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimator was used for the difference between median change of total scholastic skill score in each comparison group.|||1|0|0.2391
71122891|NCT03159104|141751290|SUPERIORITY|||||||0.0033|||||||Fisher Exact|||||||0.0033
71122892|NCT03159104|141751291|SUPERIORITY|||||||0.0012|||||||Wilcoxon (Mann-Whitney)|||||||0.0012
71122893|NCT01999218|141751295|NON_INFERIORITY|Non-inferiority is declared if the upper bound of the two-sided 95% confidence interval (CI) for the mean difference is less than 0.3%.|Difference in the Least Squares Means|0.1|||||TWO_SIDED|95.0|-0.02|0.22|||||Constrained Longitudinal Data Analysis (cLDA) model with fixed effects for treatment, time, prior antihyperglycemic medication (monotherapy or dual therapy), baseline eGFR (continuous) and the interaction of time by treatment.|||0.22|-0.02|
70856473|NCT01551420|141199533|SUPERIORITY||Slope|-4.91|STANDARD_ERROR_OF_MEAN|4.01||0.2346|TWO_SIDED|95.0|-13.3|3.43|||Regression, Linear|The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for CRIS-CAT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from CRIS-CAT: Satisfaction measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||3.43|-13.3|0.2346
70856474|NCT04268823|141199575|SUPERIORITY||Least Squares mean|-0.203|STANDARD_ERROR_OF_MEAN|0.1938||0.298|TWO_SIDED|80.0|-0.524|0.119|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||0.119|-0.524|0.298
70856475|NCT04268823|141199576|SUPERIORITY||Least Squares mean|-0.2|STANDARD_ERROR_OF_MEAN|0.44||0.651|TWO_SIDED|80.0|-0.9|0.5|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||0.5|-0.9|0.651
70856476|NCT04268823|141199577|SUPERIORITY||Least Squares mean|-1.39|STANDARD_ERROR_OF_MEAN|1.29||0.288|TWO_SIDED|80.0|-3.55|0.78|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||0.78|-3.55|0.288
70856477|NCT04268823|141199578|SUPERIORITY||Least Squares mean|4.2|STANDARD_ERROR_OF_MEAN|4.336||0.338|TWO_SIDED|80.0|-3.09|11.48|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||11.48|-3.09|0.338
70856478|NCT04268823|141199579|SUPERIORITY||Least Squares mean|-0.82|STANDARD_ERROR_OF_MEAN|3.147||0.795|TWO_SIDED|80.0|-6.05|4.42|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Total score||4.42|-6.05|0.795
71085272|NCT00676403|141676630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|8.0||0.8269||95.0|-17.5|14.0|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.0|-17.5|0.8269
71085273|NCT00676403|141676630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.1|STANDARD_ERROR_OF_MEAN|8.34||0.3319||95.0|-24.5|8.3|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.3|-24.5|0.3319
71085274|NCT00676403|141676630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5|STANDARD_ERROR_OF_MEAN|8.09||0.7552||95.0|-13.4|18.5|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.5|-13.4|0.7552
71085275|NCT00676403|141676630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.3|STANDARD_ERROR_OF_MEAN|8.16||0.0137||95.0|-36.3|-4.2|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-4.2|-36.3|0.0137
71085276|NCT00676403|141676630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.0|STANDARD_ERROR_OF_MEAN|8.22||0.1157||95.0|-29.2|3.2|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.2|-29.2|0.1157
70856479|NCT04268823|141199579|SUPERIORITY||Least Squares mean|5.75|STANDARD_ERROR_OF_MEAN|4.155||0.17|TWO_SIDED|80.0|-1.16|12.66|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Symptoms score||12.66|-1.16|0.170
70856480|NCT04268823|141199579|SUPERIORITY||Least Squares mean|-0.61|STANDARD_ERROR_OF_MEAN|3.259||0.851|TWO_SIDED|80.0|-6.02|4.8|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Activity score||4.80|-6.02|0.851
70856481|NCT04268823|141199579|SUPERIORITY||Least Squares mean|-2.07|STANDARD_ERROR_OF_MEAN|4.035||0.61|TWO_SIDED|80.0|-8.78|4.65|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Impact score||4.65|-8.78|0.610
70856482|NCT04268823|141199580|SUPERIORITY||Least Squares mean|0.25|STANDARD_ERROR_OF_MEAN|4.557||0.956|TWO_SIDED|80.0|-7.3|7.8|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Cough symptom score||7.80|-7.30|0.956
70856483|NCT04268823|141199580|SUPERIORITY||Least Squares mean|4.22|STANDARD_ERROR_OF_MEAN|4.671||0.369|TWO_SIDED|80.0|-3.55|11.99|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Sputum symptom score||11.99|-3.55|0.369
70856484|NCT04268823|141199580|SUPERIORITY||Least Squares mean|2.03|STANDARD_ERROR_OF_MEAN|4.001||0.613|TWO_SIDED|80.0|-4.61|8.68|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Cough impact score||8.68|-4.61|0.613
70856485|NCT04268823|141199580|SUPERIORITY||Least Squares mean|0.94|STANDARD_ERROR_OF_MEAN|4.518||0.835|TWO_SIDED|80.0|-6.58|8.47|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Sputum impact score||8.47|-6.58|0.835
70856486|NCT04268823|141199582|SUPERIORITY||Least Squares Mean|0.0|STANDARD_ERROR_OF_MEAN|0.04||0.335|TWO_SIDED|80.0|0.0|0.1|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||0.1|0.0|0.335
70856487|NCT04268823|141199583|SUPERIORITY||Least Squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.645|TWO_SIDED|80.0|-0.1|0.1|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||0.1|-0.1|0.645
70856488|NCT04268823|141199584|SUPERIORITY||Least Squares mean|2.1|STANDARD_ERROR_OF_MEAN|0.8||0.01|TWO_SIDED|80.0|0.8|3.4|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||3.4|0.8|0.010
70856489|NCT02882152|141199595|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||"Results were compared by means of the ANOVA of repeated measures followed by Bonferroni test.~Comparing: all four moments, from zero to 72hs within femoral blockade group, all four moments within morphine group, and all four moments between the groups"||||<0.05
70856490|NCT02882152|141199596|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||"Results were compared by means of the ANOVA of repeated measures followed by Bonferroni test.~Comparing: all four moments, from zero to 72hs within femoral blockade group, all four moments within morphine group, and all four moments between the groups"||||<0.05
70856491|NCT01437995|141199617|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.3|0.69|1.65||||||||1.65|0.69|
70856492|NCT01437995|141199618|SUPERIORITY_OR_OTHER|||||||0.43|||||||Kruskal-Wallis|||||||0.43
70856493|NCT01437995|141199618|SUPERIORITY_OR_OTHER|||||||0.022|||||||Kruskal-Wallis|||||||0.022
71085277|NCT00676403|141676630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.1|STANDARD_ERROR_OF_MEAN|8.04||0.3791||95.0|-22.9|8.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.7|-22.9|0.3791
71085278|NCT00676403|141676630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.7|STANDARD_ERROR_OF_MEAN|8.39||0.1329||95.0|-29.2|3.9|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.9|-29.2|0.1329
71122894|NCT01999218|141751295|NON_INFERIORITY|Non-inferiority is declared if the upper bound of the two-sided 95% confidence interval (CI) for the mean difference is less than 0.3%.|Difference in the Least Squares means|0.18|||||TWO_SIDED|95.0|0.06|0.3|||||"Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (monotherapy or dual therapy), baseline eGFR (continuous) and the interaction of time by treatment.~Time was treated as a categorical variable."|||0.30|0.06|
71122895|NCT01999218|141751296|OTHER|Based on Miettinen \& Nurminen method|Difference in % vs. Glimepiride|1.6|||||TWO_SIDED|95.0|-4.5|7.7||||||||7.7|-4.5|
71122896|NCT01999218|141751296|OTHER|Based on Miettinen \& Nurminen method|Difference in % vs. Glimepiride|0.5|||||TWO_SIDED|95.0|-5.6|6.5||||||||6.5|-5.6|
70856494|NCT01437995|141199618|SUPERIORITY_OR_OTHER|||||||0.002|||||||Kruskal-Wallis|||||||0.002
71122897|NCT01999218|141751297|OTHER||Difference in % vs. Glimepiride|3.0|||||TWO_SIDED|95.0|-0.3|6.4||||||||6.4|-0.3|
71122898|NCT01999218|141751297|OTHER||Difference in % vs. Glimepiride|1.5|||||TWO_SIDED|95.0|-1.7|4.7||||||||4.7|-1.7|
70856495|NCT01437995|141199619|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.63|1.41||||||||1.41|0.63|
70856496|NCT01437995|141199619|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.18|||||TWO_SIDED|95.0|0.8|1.73||||||||1.73|0.80|
70856497|NCT01437995|141199619|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.24|||||TWO_SIDED|95.0|0.83|1.81||||||||1.81|0.83|
70856498|NCT01437995|141199620|SUPERIORITY_OR_OTHER|||||||0.15|||||||Kruskal-Wallis|||Comparing change in pre-bronchodilator FEV1||||0.15
70856499|NCT01437995|141199620|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Kruskal-Wallis|||Comparing change in pre-bronchodilator FEV1||||<0.001
70856500|NCT01437995|141199620|SUPERIORITY_OR_OTHER|||||||0.027|||||||Kruskal-Wallis|||Comparing change in pre-bronchodilator FEV1||||0.027
71122899|NCT01999218|141751298|OTHER||Difference in % vs. Glimepiride|-14.0|||<|0.001|TWO_SIDED|95.0|-18.4|-9.8|||Based on Miettinen & Nurminen method||||Based on Miettinen \& Nurminen method|-9.8|-18.4|<0.001
70856501|NCT01437995|141199620|SUPERIORITY_OR_OTHER|||||||0.4|||||||Kruskal-Wallis|||Comparison of change in pre-bronchodilator FVC||||0.40
70856502|NCT01437995|141199620|SUPERIORITY_OR_OTHER|||||||0.032|||||||Kruskal-Wallis|||Comparison of change in pre-bronchodilator FVC||||0.032
70856503|NCT01437995|141199620|SUPERIORITY_OR_OTHER|||||||0.21|||||||Kruskal-Wallis|||Comparison of change in pre-bronchodilator FVC||||0.21
70856504|NCT01437995|141199621|SUPERIORITY_OR_OTHER|||||||0.14|||||||Kruskal-Wallis|||Comparison of change in FEV1/FVC ratio||||0.14
70856505|NCT01437995|141199621|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Kruskal-Wallis|||Comparison of change in FEV1/FVC ratio||||<0.001
70856506|NCT01437995|141199621|SUPERIORITY_OR_OTHER|||||||0.031|||||||Kruskal-Wallis|||Comparison of change in FEV1/FVC ratio||||0.031
71122900|NCT01999218|141751298|OTHER||Difference in % vs. Glimepiride|-16.1|||<|0.001|TWO_SIDED|95.0|-20.3|-12.2|||Based on Miettinen & Nurminen method||||Based on Miettinen \& Nurminen method|-12.2|-20.3|<0.001
70944805|NCT02705625|141389994|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in CTX-I score at Week 26.|Mean Difference (Final Values)|-0.254|||<|0.0001|TWO_SIDED|95.0|-0.302|-0.206||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: CTX-I score is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline CTX-I score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||-0.206|-0.302|<0.0001
70944806|NCT02705625|141389994|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in CTX-I score at Week 26.|Mean Difference (Final Values)|-0.145|||<|0.0001|TWO_SIDED|95.0|-0.193|-0.0983||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: CTX-I score is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline CTX-I score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||-0.0983|-0.193|<0.0001
71085279|NCT00676403|141676630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|8.09||0.7723||95.0|-13.6|18.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.3|-13.6|0.7723
71122901|NCT01999218|141751299|OTHER||Difference in LSM vs. Glimepiride|-4.29|||<|0.001|TWO_SIDED|95.0|-4.77|-3.8|||Constrained Longitudinal Data analysis||LSM=Least Squares Means||Constrained Longitudinal Data analysis with fixed effects for treatment, time, interaction of time by treatment, prior antihyperglycemic medication (monotherapy or dual therapy), and baseline eGFR (continuous).|-3.80|-4.77|<0.001
71122902|NCT01999218|141751299|OTHER||Difference in the LSM vs. Glimepiride|-3.87|||<|0.001|TWO_SIDED|95.0|-4.36|-3.38|||Constrained Longitudinal Data Analysis||||Constrained Longitudinal Data Analysis with fixed effects for treatment, time, interaction of time by treatment, prior antihyperglycemic medication (monotherapy or dual therapy), and baseline eGFR (continuous).|-3.38|-4.36|<0.001
71122903|NCT01999218|141751300|OTHER||Difference in the LSM vs. Glimepiride|-4.77|||<|0.001|TWO_SIDED|95.0|-6.29|-3.25|||Constrained Logitudinal Data Analysis||||Constrained Logitudinal Data Analysis with fixed effects for treatment, time, interaction of time by treatment, prior anthyperglycemic medication (monotherapy or dual therapy), and baseline eGFR (continuous).|-3.25|-6.29|<0.001
71122904|NCT01999218|141751300|OTHER||Difference in the LSM vs. Glimepiride|-3.2|||<|0.001|TWO_SIDED|0.001|-4.73|-1.67|||Constrained Logitudinal Data Analysis||||Constrained Logitudinal Data Analysis with fixed effects for treatment, time, interaction of time by treatment, prior anthyperglycemic medication (monotherapy or dual therapy), and baseline eGFR (continuous).|-1.67|-4.73|<0.001
71122905|NCT01800318|141751301|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||RM Anova of effects of treatment groups on PIPP scores: .|ANOVA|||||||0.07
71122906|NCT01800318|141751301|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|Bonferroni correction||t test comparing baseline PIPP score with heel stick PIPP scores in group with 24% sucrose and sham NESAP.||||<0.05
71122907|NCT01800318|141751301|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|Bonferroni correction||t test comparing baseline PIPP score with heel stick PIPP scores in group with NESAP and oral water.||||<0.01
71122908|NCT01800318|141751301|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|Bonferroni correction||t test comparing baseline PIPP score with heel stick PIPP scores in group with 24% sucrose and NESAp combined.||||<0.05
71122909|NCT01800318|141751301|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|Bonferroni||t test comparing baseline PIPP score with heel stick PIPP scores in standard care group (Sham NESAP with oral water).||||<0.01
71122910|NCT01800318|141751302|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||ANOVA|||||||0.9
71122911|NCT01800318|141751303|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||ANOVA|||||||0.9
71122912|NCT01800318|141751305|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||ANOVA|F4.048||||||0.008
71122913|NCT03809910|141751335|SUPERIORITY||Adjusted Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|-0.09|-0.04||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.04|-0.09|<.0001
71122914|NCT03809910|141751336|SUPERIORITY||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|-0.17|-0.07||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.07|-0.17|<0.0001
71122915|NCT03809910|141751337|SUPERIORITY||Adjusted Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|-0.16|-0.06||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.06|-0.16|<0.0001
71122916|NCT03809910|141751338|SUPERIORITY||Adjusted Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|-0.25|-0.19||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.19|-0.25|<0.0001
71122917|NCT03809910|141751339|SUPERIORITY||Adjusted Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|-0.43|-0.33||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.33|-0.43|<0.0001
71122918|NCT03809910|141751340|SUPERIORITY||Adjusted Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|-0.39|-0.29||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.29|-0.39|<0.0001
71122919|NCT03809910|141751341|SUPERIORITY||Adjusted Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.13|0.18||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.18|0.13|<0.0001
71122920|NCT03809910|141751342|SUPERIORITY||Adjusted Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.21|0.31||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.31|0.21|<0.0001
71122921|NCT03809910|141751343|SUPERIORITY||Adjusted Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.18|0.28||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.28|0.18|<0.0001
71122922|NCT03809910|141751344|SUPERIORITY||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.09|0.15||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.15|0.09|<0.0001
70856507|NCT04456673|141199627|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Risk Difference (RD)|-0.435||||0.0002|TWO_SIDED|95.0|-0.682|-0.188|||Negative binomial model||Derived using delta method|Derived using negative binomial model with the total number of the events occurring during the 52-week treatment period as the response variable, and treatment group, region (pooled country), ICS dose, smoking status at screening, baseline disease severity, and number of moderate or severe COPD exacerbation events within one year prior to the study as covariates, and log-transformed treatment duration as an offset variable.||-0.188|-0.682|0.0002
70856508|NCT04456673|141199628|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Least Square (LS) Mean Difference|0.082||||0.0001|TWO_SIDED|95.0|0.04|0.124|||MMRM model|||Derived from mixed-effect model with repeated measures (MMRM) model with the change from baseline in pre-bronchodilator FEV1 up to Week 12 as response variables, and treatment group, age, sex, height, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline pre-bronchodilator FEV1, and FEV1 baseline-by-visit interaction as covariates.||0.124|0.040|0.0001
70856509|NCT04456673|141199629|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|LS Mean Difference|-3.371||||0.0068|TWO_SIDED|95.0|-5.811|-0.931|||MMRM model|||Derived from MMRM model with the change from baseline in SGRQ total score up to Week 52 as response variables, and treatment group, region (pooled country), ICS dose, smoking status at screening, treatment-by-visit interaction, baseline SGRQ total score, and SGRQ baseline-by-visit interaction as covariates.||-0.931|-5.811|0.0068
70856510|NCT04456673|141199630|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Odds Ratio (OR)|1.164||||0.3329|TWO_SIDED|95.0|0.856|1.581|||Regression, Logistic|||Derived from logistic regression model which includes treatment group, region (pooled country), ICS dose, smoking status at screening, and baseline SGRQ total score as covariates.||1.581|0.856|0.3329
70856511|NCT04456673|141199631|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|LS Mean Difference|0.062||||0.0182|TWO_SIDED|95.0|0.011|0.113|||MMRM model|||Derived from MMRM model with the change from baseline in pre-bronchodilator FEV1 up to Week 52 as response variables, and treatment group, age, sex, height, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline pre-bronchodilator FEV1, and FEV1 baseline-by-visit interaction as covariates.||0.113|0.011|0.0182
71085280|NCT00676403|141676630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.5|STANDARD_ERROR_OF_MEAN|8.16||0.0063||95.0|-38.6|-6.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-6.4|-38.6|0.0063
70856512|NCT03874429|141199647|NON_INFERIORITY|Non- inferiority was demonstrated if the upper bound of the 95% CI was no higher than 2 points for the the difference of T2259 minus Vismed Multi.|Mean Difference (Net)|0.31|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|95.0|-0.42|1.05|||ANCOVA|||To assess the non inferiority of T2259 compared to Vismed Multi, two-sided 95% confidence interval from ANCOVA model was computed of the difference of T2259 minus Vismed Multi. The model was adjusted for the main effects of investigation product and baseline score.||1.05|-0.42|
70856513|NCT00246571|141199661|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.203||||0.8885|TWO_SIDED|95.0|0.8889|1.628||One-sided log-rank test stratified for the number of prior chemotherapy regiments (1 versus more than 1), which is from the interactive voice response system (IVRS).|Log Rank|||For core radiology laboratory assessment||1.6280|0.8889|0.8885
70856514|NCT00246571|141199661|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1598||||0.8472|TWO_SIDED|95.0|0.8703|1.5457||One-sided log-rank test stratified for the number of prior chemotherapy regiments (1 versus more than 1), which is from IVRS.|Log Rank|||For investigator's assessment||1.5457|0.8703|0.8472
71122923|NCT03809910|141751344|SUPERIORITY||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.014||0.0214|TWO_SIDED|95.0|-0.06|0.0||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.00|-0.06|0.0214
70856515|NCT00246571|141199662|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.38||||0.9624|TWO_SIDED|95.0|0.06|1.71||The stratified analysis was from Cochran-Mantel-Haenszel (CMH) test stratified by randomization stratification factor, the number of prior chemotherapy regimens (1 versus more than 1), which is from IVRS.|Cochran-Mantel-Haenszel|||Core radiology laboratory assessment||1.71|0.06|0.9624
70856516|NCT00246571|141199662|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.814|TWO_SIDED|95.0|0.27|1.98||The stratified analysis was from Cochran-Mantel-Haenszel (CMH) test stratified by randomization stratification factor, the number of prior chemotherapy regimens (1 versus more than 1), which is from IVRS.|Cochran-Mantel-Haenszel|||Investigator's assessment||1.98|0.27|0.8140
70856517|NCT00246571|141199665|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1599||||0.8394|TWO_SIDED|95.0|0.8648|1.5558||One-sided log rank test stratified for the number of prior chemotherapy regimens (1 versus more than 1), which is from IVRS.|Log Rank||Hazard ratio for sunitinib versus standard of care.|||1.5558|0.8648|0.8394
70856518|NCT04896229|141199681|SUPERIORITY||Slope|1.2|STANDARD_ERROR_OF_MEAN|0.52||0.022|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.022
70856519|NCT04896229|141199682|SUPERIORITY||Slope|0.09|STANDARD_ERROR_OF_MEAN|0.35||0.8|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.800
70856520|NCT04896229|141199683|SUPERIORITY||Slope|0.58|STANDARD_ERROR_OF_MEAN|0.49||0.235|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.235
70856521|NCT04896229|141199684|SUPERIORITY||Slope|0.29|STANDARD_ERROR_OF_MEAN|0.3||0.325|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.325
70856522|NCT04896229|141199685|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.502|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.502
70856523|NCT04896229|141199686|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.02||0.005|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.005
70856524|NCT04896229|141199687|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.03||0.712|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.712
70856525|NCT04896229|141199688|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.245|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.245
70856526|NCT04896229|141199689|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.282|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.282
70856527|NCT04896229|141199690|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.03||0.289|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.289
70856528|NCT04896229|141199691|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.296|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.296
70856529|NCT00159822|141199694|SUPERIORITY_OR_OTHER||Percent of subjects with success|31.7||||||95.0|18.08|48.09|||||Number of subjects with successful global outcomes were summarized and 95% two-sided confidence intervals based on the exact Clopper-Pearson method for the binomial distribution provided.|For sample size calculation, null hypothesis (p\<p0) is defined as response rate \<15% (ie, weak drug efficacy). Alternative hypothesis (p\>pA) defined as response rate \>30%. To reduce the chance of incorrectly rejecting the null hypothesis to 5% (α=5%) and incorrectly rejecting the alternate hypothesis to 20% (β=20%) it was calculated that a sample size of 48 subjects was required. Null hypothesis was rejected (assessing efficacy of study drug) if the number of eligible success was ≥ than n=12.||48.09|18.08|
70856530|NCT00159822|141199695|SUPERIORITY_OR_OTHER||Percent of subjects with success|33.3||||||95.0|18.6|51.0|||||Number of subjects with successful global outcomes were summarized and 95% two-sided confidence intervals based on the exact Clopper-Pearson method for the binomial distribution provided.|Month 3 success=yes||51.0|18.6|
71085281|NCT00676403|141676631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.254||0.1715||95.0|-0.15|0.85|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.85|-0.15|0.1715
70856531|NCT00159822|141199695|SUPERIORITY_OR_OTHER||Percent of subjects with success|43.9||||||95.0|28.5|60.3|||||Number of subjects with successful global outcomes were summarized and 95% two-sided confidence intervals based on the exact Clopper-Pearson method for the binomial distribution provided.|EOT success=yes||60.3|28.5|
70856532|NCT00159822|141199701|SUPERIORITY_OR_OTHER||Kaplan-Meier estimate overall survival|0.85||||||95.0|0.725|0.976|||||Global survival rate calculated using Kaplan-Meier estimate of overall survival.|||0.976|0.725|
70856533|NCT00713310|141199706|SUPERIORITY_OR_OTHER||High-Low Dose Difference Success Rates|-1.1||||0.924|TWO_SIDED|95.0|-22.7|20.5|||Cochran-Mantel-Haenszel|||A total of about 100 subjects were to be enrolled in the study with the expectation that about 80 subjects (40/dose level) would complete. Minimum of 9 subjects in 5-8 year old range were to be enrolled, 4-5 per dose level (high/low). A 2-sided α=0.05 Fisher's Exact test has an estimated power of P=0.50 with 40 subjects per dose level.||20.5|-22.7|0.9240
70856534|NCT00713310|141199707|SUPERIORITY_OR_OTHER||High-Low Dose Difference Success Rates|1.4||||0.8193|TWO_SIDED|95.0|-20.2|23.0|||Cochran-Mantel-Haenszel|||A total of about 100 subjects were to be enrolled in the study with the expectation that about 80 subjects (40/dose level) would complete. Minimum of 9 subjects in 5-8 year old range were to be enrolled, 4-5 per dose level (high/low). A 2-sided α=0.05 Fisher's Exact test has an estimated power of P=0.50 with 40 subjects per dose level.||23.0|-20.2|0.8193
71085282|NCT00676403|141676631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.251||0.7944||95.0|-0.43|0.56|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.56|-0.43|0.7944
70944807|NCT02705625|141389995|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in CTX-II score at Week 26.|Mean Difference (Final Values)|-270.0|||<|0.0001|TWO_SIDED|95.0|-339.0|-201.0||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: CTX-II score is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline CTX-II score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||-201|-339|<0.0001
71122924|NCT03809910|141751345|SUPERIORITY||Adjusted Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.13|0.23||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.23|0.13|<0.0001
71122925|NCT03809910|141751345|SUPERIORITY||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.025||0.001|TWO_SIDED|95.0|-0.14|-0.04||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.04|-0.14|0.0010
71122926|NCT03809910|141751346|SUPERIORITY||Adjusted Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.15|0.25||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.25|0.15|<0.0001
71122927|NCT03809910|141751346|SUPERIORITY||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.026||0.1652|TWO_SIDED|95.0|-0.09|0.01||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.01|-0.09|0.1652
71122928|NCT04948307|141751413|SUPERIORITY|||||||0.7326|||||||Chi-squared|||||||0.7326
71122929|NCT04948307|141751414|SUPERIORITY|||||||0.7396|||||||Kolmogorov-Smirnoff|||||||0.7396
71122930|NCT04948307|141751415|SUPERIORITY|||||||0.871|||||||Kolmogorov-Smirnoff|||||||0.8710
71122931|NCT04948307|141751416|SUPERIORITY|||||||0.8816|||||||Kolmogorov-Smirnoff|||||||0.8816
71122932|NCT04948307|141751417|SUPERIORITY|||||||0.5281|||||||Chi-squared|||||||0.5281
71122933|NCT04948307|141751418|SUPERIORITY|||||||0.2996|||||||Chi-squared|||||||0.2996
71122934|NCT04948307|141751422|SUPERIORITY|||||||0.7201|||||||Kolmogorov-Smirnoff|||||||0.7201
71122935|NCT04948307|141751424|OTHER|||||||||||||||||Summary statistics are presented.|Summary statistics are presented|||
71122936|NCT04948307|141751426|OTHER||||||||||||||||||Summary statistics are presented.|||
71122937|NCT02262078|141751499|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||||||0.002
71122938|NCT01688739|141751502|OTHER||Ratio of Geometric Means|1.1||||0.7595|TWO_SIDED|90.0|0.8|1.4|||ANCOVA||Migraine participants / Healthy Participants|||1.4|0.8|0.7595
71122939|NCT01688739|141751504|OTHER||Ratio of Geometric Means|1.1||||0.5481|TWO_SIDED|90.0|0.9|1.4|||ANCOVA||Migraine participants / Healthy participants|||1.4|0.9|0.5481
71122940|NCT01688739|141751505|OTHER||Ratio of Geometric Means|1.1||||0.5506|TWO_SIDED|90.0|0.9|1.4|||ANCOVA||Migraine participants / Healthy participants|||1.4|0.9|0.5506
70944808|NCT02705625|141389995|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in CTX-II score at Week 26.|Mean Difference (Final Values)|-193.0|||<|0.0001|TWO_SIDED|95.0|-262.0|-124.0||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: CTX-II score is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by- time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline CTX-II score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||-124|-262|<0.0001
70944809|NCT03677245|141390031|OTHER|Wilcoxon signed ranks test used to compared pre-intervention to post-intervention means of the Pediatric Balance Scale. No power calculation performed or utilized.|Mean Difference (Final Values)|1.0|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70944810|NCT02287883|141390044|OTHER|Clustered two-sample t-test||||||0.8|||||||t-test, 2 sided|||||||0.80
70944811|NCT02287883|141390045|OTHER|Clustered two-sample t-test||||||0.48|||||||t-test, 2 sided|||||||0.48
70944812|NCT02287883|141390046|OTHER|Clustered two-sample t-test||||||0.05|||||||t-test, 2 sided|||||||0.05
70944813|NCT00802438|141390047|OTHER||||||<|0.0001||||||A two-sided p-value\<0.05 was considered significant. Analyses were conducted using SAS version 9.4 (SAS Institute, Cary, NC.).|t-test, 2 sided|||Summaries of log-transformed data were back-transformed to the original scale and reported as geometric mean with 95% confidence interval or median within 1st and 3rd quartiles. Outcomes are summarized using least squares means with 95% confidence intervals or median with 1st and 3rd quartiles.||||<0.0001
70944814|NCT00802438|141390048|OTHER|Summaries of log-transformed data were back-transformed to the original scale and reported as geometric mean with 95% confidence interval or median within 1st and 3rd quartiles. Outcomes are summarized using least squares means with 95% confidence intervals or median with 1st and 3rd quartiles.||||||0.01|||||||t-test, 2 sided|||||||0.01
70944815|NCT01193218|141390055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.87|-0.57||the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.|ANCOVA|'treatment', 'renal function', and 'number of previous antidiabetic medication' as a fixed effect and baseline HbA1c as a covariate||Difference calculated as empa 5mg minus placebo||-0.57|-0.87|<0.0001
70944816|NCT01193218|141390055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.85|-0.55||the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.|ANCOVA|'treatment', 'renal function', and 'number of previous antidiabetic medication' as a fixed effect and baseline HbA1c as a covariate||Difference calculated as empa 10mg minus placebo||-0.55|-0.85|<0.0001
70944817|NCT01193218|141390055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-1.1|-0.8||the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.|ANCOVA|'treatment', 'renal function', and 'number of previous antidiabetic medication' as a fixed effect and baseline HbA1c as a covariate||Difference calculated as empa 25mg minus placebo||-0.80|-1.10|<0.0001
70944818|NCT01193218|141390055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-1.06|-0.76||the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.|ANCOVA|'treatment', 'renal function', and 'number of previous antidiabetic medication' as a fixed effect and baseline HbA1c as a covariate||Difference calculated as empa 50mg minus placebo||-0.76|-1.06|<0.0001
70944819|NCT01193218|141390056|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|19.367|||<|0.0001|TWO_SIDED|95.0|5.34|70.236|||Regression, Logistic|The model includes 'treatment', 'renal function', 'number of previous antidiabetic medications' and 'continuous baseline HbA1c'.||Odds ratio calculated as the odds of Empa 5mg divided by the odds of placebo||70.236|5.340|<0.0001
70944820|NCT01193218|141390056|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.889||||0.0003|TWO_SIDED|95.0|2.942|40.301|||Regression, Logistic|The model includes 'treatment', 'renal function', 'number of previous antidiabetic medications' and 'continuous baseline HbA1c'.||Odds ratio calculated as the odds of Empa 10mg divided by the odds of placebo||40.301|2.942|0.0003
70944821|NCT01193218|141390056|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|27.624|||<|0.0001|TWO_SIDED|95.0|7.601|99.99|||Regression, Logistic|The model includes 'treatment', 'renal function', 'number of previous antidiabetic medications' and 'continuous baseline HbA1c'.|The upper limit of confidence interval is actually \>99.99|Odds ratio calculated as the odds of Empa 25mg divided by the odds of placebo||99.99|7.601|<0.0001
70944822|NCT01193218|141390056|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|44.906|||<|0.0001|TWO_SIDED|95.0|12.12|99.99|||Regression, Logistic|The model includes 'treatment', 'renal function', 'number of previous antidiabetic medications' and 'continuous baseline HbA1c'.|The upper limit of confidence interval is actually \>99.99|Odds ratio calculated as the odds of Empa 50mg divided by the odds of placebo||99.99|12.120|<0.0001
70944823|NCT01193218|141390057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.7|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-31.61|-21.8|||ANCOVA|treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates||Difference calculated as empa 5mg minus placebo||-21.80|-31.61|<0.0001
70944824|NCT01193218|141390057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.34|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-34.25|-24.42|||ANCOVA|treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates||Difference calculated as empa 10mg minus placebo||-24.42|-34.25|<0.0001
70944825|NCT01193218|141390057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-37.75|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-42.66|-32.84|||ANCOVA|treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates||Difference calculated as empa 25mg minus placebo||-32.84|-42.66|<0.0001
71122941|NCT00996801|141751507|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.96||||0.012|TWO_SIDED|95.0|-3.58|-0.35||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.35|-3.58|0.012
71122942|NCT00996801|141751507|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.81||||0.019|TWO_SIDED|95.0|-3.37|-0.25||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.25|-3.37|0.019
71122943|NCT00996801|141751507|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.82||||0.019|TWO_SIDED|95.0|-3.23|-0.41||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.41|-3.23|0.019
71122944|NCT00996801|141751508|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-2.64|||<|0.001|TWO_SIDED|95.0|-3.9|-1.38||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-1.38|-3.90|<0.001
71122945|NCT00996801|141751508|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-2.62|||<|0.001|TWO_SIDED|95.0|-3.83|-1.4||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-1.40|-3.83|<0.001
71122946|NCT00996801|141751508|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-2.12|||<|0.001|TWO_SIDED|95.0|-3.22|-1.02||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-1.02|-3.22|<0.001
71122947|NCT00996801|141751508|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-0.74||||0.376|TWO_SIDED|95.0|-1.99|0.52||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.52|-1.99|0.376
71122948|NCT00996801|141751508|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.71||||0.376|TWO_SIDED|95.0|-1.93|0.5||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.50|-1.93|0.376
71122949|NCT00996801|141751508|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.22||||0.699|TWO_SIDED|95.0|-1.32|0.88||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.88|-1.32|0.699
71122950|NCT00996801|141751509|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-2.04||||0.002|TWO_SIDED|95.0|-3.43|-0.64||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.64|-3.43|0.002
71122951|NCT00996801|141751509|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.29||||0.035|TWO_SIDED|95.0|-2.48|-0.09||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.09|-2.48|0.035
70944826|NCT01193218|141390057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.6|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-41.51|-31.69|||ANCOVA|treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates||Difference calculated as empa 50mg minus placebo||-31.69|-41.51|<0.0001
71122952|NCT00996801|141751509|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.76||||0.009|TWO_SIDED|95.0|-3.14|-0.38||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.38|-3.14|0.009
71122953|NCT00996801|141751509|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.86||||0.335|TWO_SIDED|95.0|-2.26|0.54||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.54|-2.26|0.335
71122954|NCT00996801|141751509|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.11||||0.857|TWO_SIDED|95.0|-1.3|1.08||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.08|-1.30|0.857
70856535|NCT00329901|141199716|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference \[(Tdap + MenACWY-CRM) minus(Tdap + saline)\] was greater than -10, at 1 month (Day 29) after vaccination|Vaccine Group difference|9.0|||||TWO_SIDED|95.0|5.0|14.0||||||Non-inferiority of anti-diphtheria immune response following concomitant administration of Tdap with MenACWY-CRM as compared to Tdap given with placebo saline||14|5|
70856536|NCT00329901|141199716|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference \[(Tdap + MenACWY-CRM) minus(Tdap + saline)\] was greater than -10, at 1 month (Day 29) after vaccination|Vaccine Group Difference|1.0|||||TWO_SIDED|95.0|-1.0|2.0||||||Non-inferiority of anti-tetanus immune response following concomitant administration of Tdap with MenACWY-CRM compared to Tdap given concomitantly with saline placebo||2|-1|
70856537|NCT00329901|141199716|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference \[(Tdap + MenACWY-CRM) minus (Tdap + saline)\] was greater than -10, at 1 month (Day 29) after vaccination|Vaccine Group difference|-5.0|||||TWO_SIDED|95.0|-12.0|1.0||||||Non-inferiority of anti-PT antigen immune response following concomitant administration of Tdap with MenACWY as compared to Tdap given concomitantly with saline placebo||1|-12|
70856538|NCT00329901|141199716|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference \[(Tdap + MenACWY-CRM) minus (Tdap + saline)\] was greater than -10, at 1 month (Day 29) after vaccination|Vaccine Group Difference|-3.0|||||TWO_SIDED|95.0|-9.0|3.0||||||Non-inferiority of anti-FHA antigen immune response following concomitant administration of Tdap with MenACWY as compared to Tdap given concomitantly with saline placebo||3|-9|
70856539|NCT00329901|141199716|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference \[(Tdap + MenACWY-CRM) minus (Tdap + saline)\] was greater than -10, at 1 month (Day 29) after vaccination|Vaccine Group Difference|-7.0|||||TWO_SIDED|95.0|-13.0|-2.0||||||Non-inferiority of anti-PRN antigen immune response following concomitant administration of Tdap with MenACWY as compared to Tdap given concomitantly with saline placebo||-2|-13|
71122955|NCT00996801|141751509|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.59||||0.542|TWO_SIDED|95.0|-1.96|0.79||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.79|-1.96|0.542
71122956|NCT00996801|141751510|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-3.24|||<|0.001|TWO_SIDED|95.0|-4.91|-1.57||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-1.57|-4.91|<0.001
71122957|NCT00996801|141751510|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-3.18|||<|0.001|TWO_SIDED|95.0|-4.78|-1.57||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-1.57|-4.78|<0.001
71122958|NCT00996801|141751510|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-3.2|||<|0.001|TWO_SIDED|95.0|-4.66|-1.74||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-1.74|-4.66|<0.001
71122959|NCT00996801|141751510|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.27||||0.18|TWO_SIDED|95.0|-2.93|0.4||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.40|-2.93|0.180
71122960|NCT00996801|141751510|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.2||||0.18|TWO_SIDED|95.0|-2.81|0.4||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.40|-2.81|0.180
71122961|NCT00996801|141751510|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.22||||0.18|TWO_SIDED|95.0|-2.68|0.23||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.23|-2.68|0.180
71122962|NCT00996801|141751511|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.36||||0.001|TWO_SIDED|95.0|-2.18|-0.54||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.54|-2.18|0.001
71122963|NCT00996801|141751511|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.51||||0.001|TWO_SIDED|95.0|-2.46|-0.55||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.55|-2.46|0.001
71122964|NCT00996801|141751511|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.92|||<|0.001|TWO_SIDED|95.0|-2.93|-0.91||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.91|-2.93|<0.001
71122965|NCT00996801|141751511|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.37||||0.383|TWO_SIDED|95.0|-1.21|0.46||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.46|-1.21|0.383
70856540|NCT00992589|141199727|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.449||||0.168|TWO_SIDED|95.0|-1.087|0.19|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in daily average frequency of regurgitation from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.||0.190|-1.087|0.168
70856541|NCT00992589|141199728|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.03||||0.44|TWO_SIDED|95.0|-0.047|0.108|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Double-blind (DB) Baseline as covariate to test the hypothesis of no difference in change in Weight-for-Age Z-Score from DB Baseline to DB Endpoint between Rabeprazole Sodium Total and Placebo.||0.108|-0.047|0.440
70856542|NCT00992589|141199730|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.006||||0.984|TWO_SIDED|95.0|-0.619|0.632|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in weekly average I-GERQ-DD Regurgitation Subscale Score from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.||0.632|-0.619|0.984
71122966|NCT00996801|141751511|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.52||||0.383|TWO_SIDED|95.0|-1.49|0.45||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.45|-1.49|0.383
71122967|NCT00996801|141751511|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.94||||0.084|TWO_SIDED|95.0|-1.96|0.09||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.09|-1.96|0.084
71122968|NCT00996801|141751512|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.47||||0.68|TWO_SIDED|95.0|-1.88|0.94||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.94|-1.88|0.680
71122969|NCT00996801|141751512|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.01||||0.993|TWO_SIDED|95.0|-1.3|1.28||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.28|-1.30|0.993
71122970|NCT00996801|141751512|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.1||||0.23|TWO_SIDED|95.0|-2.67|0.46||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.46|-2.67|0.230
71085283|NCT00676403|141676631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.255||0.1994||95.0|-0.17|0.83|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.83|-0.17|0.1994
71085284|NCT00676403|141676631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.251||0.3652||95.0|-0.27|0.72|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.72|-0.27|0.3652
71085285|NCT00676403|141676631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.251||0.0481||95.0|0.0|0.99|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.99|0.00|0.0481
71122971|NCT00996801|141751512|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.84||||0.333|TWO_SIDED|95.0|-2.29|0.61||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.61|-2.29|0.333
71122972|NCT00996801|141751512|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.37||||0.577|TWO_SIDED|95.0|-1.69|0.94||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.94|-1.69|0.577
70944827|NCT02341599|141390159|OTHER|LS mean ratio of Group B/Group A|LS mean ratio|1.29|||||TWO_SIDED|90.0|1.06|1.58|||||LS mean ratio was calculated from analysis of variance (ANOVA) model.|||1.58|1.06|
70944828|NCT02341599|141390159|OTHER|LS mean ratio of Group C/Group A|LS mean ratio|1.08|||||TWO_SIDED|90.0|0.889|1.32|||||LS mean ratio was calculated from ANOVA model.|||1.32|0.889|
71085286|NCT00676403|141676631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.256||0.2501||95.0|-0.21|0.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.80|-0.21|0.2501
71085287|NCT00676403|141676631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.252||0.5191||95.0|-0.33|0.66|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.66|-0.33|0.5191
71122973|NCT00996801|141751512|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.47||||0.078|TWO_SIDED|95.0|-3.07|0.12||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.12|-3.07|0.078
71122974|NCT00996801|141751513|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.99||||0.094|TWO_SIDED|95.0|-4.22|0.25||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.25|-4.22|0.094
71122975|NCT00996801|141751513|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.66||||0.157|TWO_SIDED|95.0|-3.82|0.5||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.50|-3.82|0.157
71122976|NCT00996801|141751513|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.57||||0.157|TWO_SIDED|95.0|-3.53|0.38||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.38|-3.53|0.157
71122977|NCT00996801|141751513|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.43||||0.937|TWO_SIDED|95.0|-2.61|1.76||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.76|-2.61|0.937
71122978|NCT00996801|141751513|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.1||||0.992|TWO_SIDED|95.0|-2.21|2.01||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.01|-2.21|0.992
70944829|NCT02341599|141390159|OTHER|LS mean ratio of Group D/Group A|LS mean ratio|2.51|||||TWO_SIDED|90.0|2.06|3.06|||||LS mean ratio was calculated from ANOVA model.|||3.06|2.06|
70944830|NCT02341599|141390159|OTHER|LS mean ratio of Group E: Period 1/Group A|LS mean ratio|0.989|||||TWO_SIDED|90.0|0.806|1.21|||||LS mean ratio was calculated from ANOVA model.|||1.21|0.806|
71122979|NCT00996801|141751513|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.01||||0.992|TWO_SIDED|95.0|-1.93|1.9||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.90|-1.93|0.992
71122980|NCT00996801|141751514|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.47||||0.824|TWO_SIDED|95.0|-2.5|1.56||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.56|-2.50|0.824
70944831|NCT02341599|141390159|OTHER|LS mean ratio of Group E: Period 2/Group A|LS mean ratio|3.27|||||TWO_SIDED|90.0|2.67|4.02|||||LS mean ratio was calculated from ANOVA model.|||4.02|2.67|
70944832|NCT02341599|141390159|OTHER|LS mean ratio of Group E: Period 1/Group E: Period 2|LS mean ratio|0.299|||||TWO_SIDED|90.0|0.236|0.378|||||LS mean ratio was calculated from ANOVA model.|||0.378|0.236|
70944833|NCT02341599|141390160|OTHER|LS mean ratio of Group B/Group A|LS mean ratio|1.04|||||TWO_SIDED|90.0|0.846|1.27|||||LS mean ratio was calculated from ANOVA model.|||1.27|0.846|
70944834|NCT02341599|141390160|OTHER|LS mean ratio of Group C/Group A|LS mean ratio|0.524|||||TWO_SIDED|90.0|0.428|0.641|||||LS mean ratio was calculated from ANOVA model.|||0.641|0.428|
71122981|NCT00996801|141751514|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.42||||0.824|TWO_SIDED|95.0|-2.28|1.43||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.43|-2.28|0.824
71122982|NCT00996801|141751514|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.96||||0.624|TWO_SIDED|95.0|-3.23|1.31||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.31|-3.23|0.624
71122983|NCT00996801|141751514|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.78||||0.7|TWO_SIDED|95.0|-1.25|2.82||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.82|-1.25|0.700
71122984|NCT00996801|141751514|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.83||||0.7|TWO_SIDED|95.0|-1.39|3.06||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||3.06|-1.39|0.700
71122985|NCT00996801|141751514|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.3||||0.759|TWO_SIDED|95.0|-1.6|2.19||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.19|-1.60|0.759
71122986|NCT00996801|141751515|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-16.22||||0.227|TWO_SIDED|95.0|-39.15|6.72||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||6.72|-39.15|0.227
71122987|NCT00996801|141751515|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.85||||0.853|TWO_SIDED|95.0|-17.9|21.61||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||21.61|-17.90|0.853
71122988|NCT00996801|141751515|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-13.14||||0.327|TWO_SIDED|95.0|-35.67|9.39||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||9.39|-35.67|0.327
71122989|NCT00996801|141751515|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-2.74||||0.94|TWO_SIDED|95.0|-23.91|18.43||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||18.43|-23.91|0.940
71122990|NCT00996801|141751515|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|15.33||||0.273|TWO_SIDED|95.0|-7.86|38.52||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||38.52|-7.86|0.273
71122991|NCT00996801|141751515|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.33||||0.973|TWO_SIDED|95.0|-19.23|19.9||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||19.90|-19.23|0.973
71122992|NCT00996801|141751516|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.48||||0.01|TWO_SIDED|95.0|-2.66|-0.29||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.29|-2.66|0.010
70944835|NCT02341599|141390160|OTHER|LS mean ratio of Group D/Group A|LS mean ratio|0.678|||||TWO_SIDED|90.0|0.554|0.831|||||LS mean ratio was calculated from ANOVA model.|||0.831|0.554|
70944836|NCT02341599|141390160|OTHER|LS mean ratio of Group E: Period 1/Group A|LS mean ratio|0.273|||||TWO_SIDED|90.0|0.221|0.336|||||LS mean ratio was calculated from ANOVA model.|||0.336|0.221|
70944837|NCT02341599|141390160|OTHER|LS mean ratio of Group E: Period 2/Group A|LS mean ratio|0.326|||||TWO_SIDED|90.0|0.265|0.402|||||LS mean ratio was calculated from ANOVA model.|||0.402|0.265|
70944838|NCT02341599|141390160|OTHER|LS mean ratio of Group E: Period 2/Group E: Period 1|LS mean ratio|0.808|||||TWO_SIDED|90.0|0.65|1.0|||||LS mean ratio was calculated from ANOVA model.|||1.00|0.650|
70944839|NCT01424189|141390173|NON_INFERIORITY_OR_EQUIVALENCE|With 300 subjects in the ReSTOR Toric IOL test group and 150 subjects in the ReSTOR IOL control group, there was over 99% power to demonstrate that the upper 95% confidence limit for the observed difference in UCDVA between IOL groups was less than the clinical performance target of 0.1 logMAR units at Month 12, assuming the true difference between groups is zero. This was based on an assumed standard deviation for UCDVA of 0.16 logMAR units and a 1-sided, α=0.05 test.|Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.013|||ONE_SIDED|95.0||0.03||||||||0.030||
70944840|NCT01424189|141390174|NON_INFERIORITY_OR_EQUIVALENCE|With 300 subjects in the ReSTOR Toric IOL test group and 150 subjects in the ReSTOR IOL control group, there was over 99% power to demonstrate that the upper 95% confidence limit for the observed difference in UCNVA between IOL groups was less than the clinical performance target of 0.1 logMAR units at Month 12, assuming the true difference between groups is zero. This estimate was based on an assumed standard deviation for UCNVA of 0.16 logMAR units and a 1-sided, α=0.05 test.|Mean Difference (Final Values)|-0.044|STANDARD_ERROR_OF_MEAN|0.015|||ONE_SIDED|95.0||-0.017||||||||-0.017||
70944841|NCT01077622|141390242|SUPERIORITY_OR_OTHER||percentage of participants|70.0|||||TWO_SIDED|95.0|34.8|93.3|||||SERC assessment|||93.3|34.8|
71122993|NCT00996801|141751516|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.14||||0.053|TWO_SIDED|95.0|-2.29|0.01||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.01|-2.29|0.053
70944842|NCT01077622|141390242|SUPERIORITY_OR_OTHER||percentage of participants|70.0|||||TWO_SIDED|95.0|34.8|93.3|||||Investigator assessment|||93.3|34.8|
71122994|NCT00996801|141751516|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.15||||0.053|TWO_SIDED|95.0|-2.19|-0.11||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.11|-2.19|0.053
70856543|NCT00992589|141199731|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.182||||0.479|TWO_SIDED|95.0|-0.69|0.325|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in weekly average I-GERQ-DD Discomfort Subscale Score from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.||0.325|-0.690|0.479
70944843|NCT00424177|141390284|SUPERIORITY_OR_OTHER||Proportion of subjects in Cycle 2 or 3|0.87||||||95.0|0.74|0.94||||||||0.94|0.74|
71085288|NCT00676403|141676631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.262||0.0817||95.0|-0.06|0.97|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.97|-0.06|0.0817
71085289|NCT00676403|141676631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.253||0.1146||95.0|-0.1|0.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.90|-0.10|0.1146
71085290|NCT00676403|141676631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|0.253||0.0054||95.0|0.21|1.21|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.21|0.21|0.0054
71085291|NCT00676403|141676631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.261||0.3389||95.0|-0.26|0.76|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.76|-0.26|0.3389
71085292|NCT00676403|141676631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.254||0.5079||95.0|-0.33|0.67|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.67|-0.33|0.5079
71085293|NCT00676403|141676631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|0.265||0.0453||95.0|0.01|1.05|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.05|0.01|0.0453
71085294|NCT00676403|141676631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.256||0.1622||95.0|-0.15|0.86|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.86|-0.15|0.1622
71085295|NCT00676403|141676631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|0.262||0.0003||95.0|0.45|1.48|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.48|0.45|0.0003
71122995|NCT00996801|141751516|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.58||||0.509|TWO_SIDED|95.0|-1.77|0.6||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.60|-1.77|0.509
71122996|NCT00996801|141751516|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.25||||0.843|TWO_SIDED|95.0|-1.27|0.77||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.77|-1.27|0.843
71085296|NCT00676403|141676631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|0.26||0.0383||95.0|0.03|1.05|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.05|0.03|0.0383
71085297|NCT00676403|141676631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.253||0.4495||95.0|-0.31|0.69|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.69|-0.31|0.4495
71085298|NCT00676403|141676631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.263||0.0135||95.0|0.14|1.17|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.17|0.14|0.0135
71122997|NCT00996801|141751516|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.26||||0.843|TWO_SIDED|95.0|-1.43|0.92||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.92|-1.43|0.843
71122998|NCT00996801|141751517|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|86.33|||<|0.001|TWO_SIDED|95.0|64.87|108.29||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||108.29|64.87|<0.001
71122999|NCT00996801|141751517|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|82.14|||<|0.001|TWO_SIDED|95.0|63.0|101.66||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||101.66|63.00|<0.001
71123000|NCT00996801|141751517|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|107.26|||<|0.001|TWO_SIDED|95.0|82.03|133.23||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||133.23|82.03|<0.001
71123001|NCT00996801|141751517|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|22.87||||0.104|TWO_SIDED|95.0|-3.8|49.68||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||49.68|-3.80|0.104
71123002|NCT00996801|141751517|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|18.68||||0.123|TWO_SIDED|95.0|-5.11|42.56||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||42.56|-5.11|0.123
71123003|NCT00996801|141751517|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|43.8||||0.003|TWO_SIDED|95.0|12.85|75.06||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||75.06|12.85|0.003
71085299|NCT00676403|141676631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.254||0.1423||95.0|-0.13|0.87|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.87|-0.13|0.1423
71085300|NCT00676403|141676631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.259||0.0035||95.0|0.25|1.27|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.27|0.25|0.0035
71085301|NCT00676403|141676631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.261||0.0125||95.0|0.14|1.17|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.17|0.14|0.0125
71085302|NCT00676403|141676631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.254||0.8021||95.0|-0.44|0.56|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.56|-0.44|0.8021
71085303|NCT00676403|141676631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.267||0.0249||95.0|0.08|1.13|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.13|0.08|0.0249
71085304|NCT00676403|141676631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.256||0.3383||95.0|-0.26|0.75|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.75|-0.26|0.3383
71085305|NCT00676403|141676631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.06|STANDARD_ERROR_OF_MEAN|0.26||0.0001||95.0|0.55|1.57|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.57|0.55|0.0001
71085306|NCT00676403|141676631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.261||0.0133||95.0|0.14|1.17|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.17|0.14|0.0133
71085307|NCT00676403|141676631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.256||0.382||95.0|-0.28|0.73|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.73|-0.28|0.3820
71085308|NCT00676403|141676631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.75|STANDARD_ERROR_OF_MEAN|0.269||0.0053||95.0|0.23|1.28|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.28|0.23|0.0053
71085309|NCT00676403|141676631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.256||0.3258||95.0|-0.25|0.76|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.76|-0.25|0.3258
71085310|NCT00676403|141676631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.92|STANDARD_ERROR_OF_MEAN|0.26||0.0005||95.0|0.41|1.43|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.43|0.41|0.0005
71085311|NCT00676403|141676632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.1429||95.0|-1.0|0.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.0|0.1429
71085312|NCT00676403|141676632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.0547||95.0|-1.2|0.0|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.0|-1.2|0.0547
71085313|NCT00676403|141676632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.3||0.0095||95.0|-1.4|-0.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.2|-1.4|0.0095
71085314|NCT00676403|141676632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3676||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.3676
71085315|NCT00676403|141676632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.2959||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.2959
71085316|NCT00676403|141676632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3435||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.3435
71085317|NCT00676403|141676632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.0895||95.0|-1.1|0.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.1|0.0895
71085318|NCT00676403|141676632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.31||0.0844||95.0|-1.1|0.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.1|0.0844
71123004|NCT00996801|141751518|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|187.31|||<|0.001|TWO_SIDED|95.0|154.44|221.25||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||221.25|154.44|<0.001
71123005|NCT00996801|141751518|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|200.29|||<|0.001|TWO_SIDED|95.0|161.21|240.91||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||240.91|161.21|<0.001
71123006|NCT00996801|141751518|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|224.3|||<|0.001|TWO_SIDED|95.0|180.19|270.39||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||270.39|180.19|<0.001
70856544|NCT00992589|141199732|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.192||||0.498|TWO_SIDED|95.0|-0.751|0.366|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in weekly average I-GERQ-DD Eating Behavior Subscale Score from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.||0.366|-0.751|0.498
71123007|NCT00996801|141751518|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|48.29||||0.034|TWO_SIDED|95.0|3.75|93.11||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||93.11|3.75|0.034
71123008|NCT00996801|141751518|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|61.27||||0.019|TWO_SIDED|95.0|8.8|114.22||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||114.22|8.80|0.019
70856545|NCT00992589|141199733|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.042||||0.96|TWO_SIDED|95.0|-1.615|1.7|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in I-GERQ-R Total Score from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.||1.700|-1.615|0.960
70856546|NCT00992589|141199734|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.024||||0.968|TWO_SIDED|95.0|-1.167|1.214|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in Weekly Average I-GERQ-DD Total Score from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.||1.214|-1.167|0.968
70856547|NCT02142387|141199740|OTHER|||||||0.34|TWO_SIDED|95.0|||||Chi-squared|||||||0.34
70856548|NCT02142387|141199741|OTHER|||||||0.7|||||||Chi-squared|||||||0.7
70856549|NCT02142387|141199742|OTHER|||||||0.11|||||||Chi-squared|||||||0.11
70944844|NCT01123512|141390291|NON_INFERIORITY_OR_EQUIVALENCE|"Pr( Pt - Pc \> -12.5% \| data), calculated using Bayesian multiple imputation for missing 12-month values, as specified in the protocol. The Kiva System is declared non-inferior to control if Pr( Pt - Pc \> -12.5% \| data)\> 96.6%."|% Probability of Equivalence = 99.92|99.92|||||TWO_SIDED|||||"Pr( Pt - Pc \> -12.5% \| data), calculated using Bayesian multiple imputation for missing 12-month values, as specified in the protocol. The Kiva System is declared non-inferior to control if Pr( Pt - Pc \> -12.5% \| data)\> 96.6%."|Bayesian test of proportions|||||||
71085319|NCT00676403|141676632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.0675||95.0|-1.1|0.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.0|-1.1|0.0675
71085320|NCT00676403|141676632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.225||95.0|-1.0|0.2|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.2|-1.0|0.2250
71085321|NCT00676403|141676632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.3728||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.3728
71085322|NCT00676403|141676632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.2686||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.2686
71085323|NCT00676403|141676632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.31||0.0753||95.0|-1.2|0.1|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.2|0.0753
71085324|NCT00676403|141676632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.1335||95.0|-1.0|0.1|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.0|0.1335
71085325|NCT00676403|141676632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.31||0.022||95.0|-1.3|-0.1|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.1|-1.3|0.0220
71085326|NCT00676403|141676632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.31||0.5754||95.0|-0.8|0.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.4|-0.8|0.5754
71085327|NCT00676403|141676632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.348||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.3480
71085328|NCT00676403|141676632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.31||0.0554||95.0|-1.2|0.0|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.0|-1.2|0.0554
71085329|NCT00676403|141676632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.4362||95.0|-0.8|0.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.4|-0.8|0.4362
71085330|NCT00676403|141676632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3631||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.3631
71085331|NCT00676403|141676632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.31||0.1152||95.0|-1.1|0.1|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.1|0.1152
71085332|NCT00676403|141676632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.4741||95.0|-0.8|0.4|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.4|-0.8|0.4741
71085333|NCT00676403|141676632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.31||0.0091||95.0|-1.4|-0.2|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.2|-1.4|0.0091
71085334|NCT00676403|141676632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.1721||95.0|-1.0|0.2|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.2|-1.0|0.1721
71085335|NCT00676403|141676632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.31||0.0262||95.0|-1.3|-0.1|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.1|-1.3|0.0262
71085336|NCT00676403|141676632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.31||0.9505||95.0|-0.6|0.6|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.6|-0.6|0.9505
71085337|NCT00676403|141676632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.3||0.6877||95.0|-0.7|0.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.5|-0.7|0.6877
71085338|NCT00676403|141676632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.31||0.1271||95.0|-1.1|0.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.1|0.1271
71085339|NCT00676403|141676632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9136||95.0|-0.6|0.6|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.6|-0.6|0.9136
71085340|NCT00676403|141676632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.4072||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.4072
71123009|NCT00996801|141751518|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|85.28||||0.002|TWO_SIDED|95.0|26.7|144.63||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||144.63|26.70|0.002
71123010|NCT00996801|141751519|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|133.03|||<|0.001|TWO_SIDED|95.0|110.01|156.75||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||156.75|110.01|<0.001
71123011|NCT00996801|141751519|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|133.03||||0.001|TWO_SIDED|95.0|110.01|156.75||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||156.75|110.01|0.001
71123012|NCT00996801|141751519|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|131.53|||<|0.001|TWO_SIDED|95.0|110.7|152.94||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||152.94|110.70|<0.001
71123013|NCT00996801|141751519|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|169.8|||<|0.001|TWO_SIDED|95.0|141.59|199.11||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||199.11|141.59|<0.001
70856550|NCT05028361|141199743|NON_INFERIORITY|One-sided non-inferiority test with the alpha level set at 0.025 and non-inferiority margin of 10%, stratified by site.|Difference in proportions|-5.6||||0.0007|TWO_SIDED|95.0|-15.2|4.0||The upper limit of the 95% CI of the difference was 4% with a noninferiority margin of 10%.|Cochran-Mantel-Haenszel|The upper bound of a site-stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting was used.||The null hypothesis is the Simultaneous group is inferior (i.e., Simultaneous group will have a higher proportion) to the Sequential group in regards to the proportion of participants with at least one moderate or severe fever, chills, myalgia, or arthralgia event after visits 1 and 2 using 10% non-inferiority margin.||4.0|-15.2|0.0007
71085341|NCT00676403|141676633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.2|STANDARD_ERROR_OF_MEAN|10.68||0.186||95.0|-35.2|6.9|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||6.9|-35.2|0.1860
70856551|NCT05028361|141199744|SUPERIORITY|||||||0.3851|||||||Mantel Haenszel|||||||0.3851
70856552|NCT05028361|141199745|SUPERIORITY|||||||0.2886|||||||Mantel Haenszel|||||||0.2886
70944845|NCT00496834|141390299|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= -1.5m/s|Mean Difference (Final Values)|-0.41|STANDARD_DEVIATION|1.43|||TWO_SIDED|95.0|-0.83|0.01|||||The lower limit of ≥-1.5m/s was judged to prove the non-inferiority of the test group to the control group.|Participants for analysis was modified intention to treat (Number of patients: Losartan group was 88, Carvedilol group was 94).||0.01|-0.83|
70944846|NCT00496834|141390300|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin=-1.5m/s|Mean Difference (Final Values)|-0.36|STANDARD_DEVIATION|1.4|||TWO_SIDED|95.0|-0.86|0.15|||||The lower limit of ≥-1.5m/s was judged to prove the non-inferiority of the test group to the control group.|Participants for analysis was per protocol (Number of patients: Losartan group was 54, Carvedilol group was 67). For the primary efficacy endpoints, Per protocol analysis approach was supplementary used.||0.15|-0.86|
70944847|NCT00496834|141390301|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9032||95.0||||Significance level=0.05|t-test, 2 sided|The secondary efficacy analysis was performed in the modified intention to treat population using t-test.||||||0.9032
70856553|NCT05028361|141199747|OTHER||Comparison of Frequencies|-0.01|||||TWO_SIDED|95.0|-1.66|1.64||The comparison in number of participants with reported SAEs regardless of relationship to study product were made using a difference in proportions along with a 95% confidence interval of the difference.||||||1.64|-1.66|
70944848|NCT00496834|141390302|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6574||95.0||||Significance level=0.05|t-test, 2 sided|The secondary efficacy analysis was performed in the modified intention to treat population using t-test||||||0.6574
70856554|NCT01848782|141199748|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.5|TWO_SIDED|95.0|-0.4|0.7|||Mixed Models Analysis|||||0.7|-0.4|0.5
70856555|NCT01848782|141199749|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.8|TWO_SIDED|95.0|-0.5|0.6|||Mixed Models Analysis|||||0.6|-0.5|0.8
70856556|NCT01848782|141199750|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.6|TWO_SIDED|95.0|-0.4|0.7|||Mixed Models Analysis|||||0.7|-0.4|0.6
70944849|NCT04333732|141390351|SUPERIORITY||Risk Difference (RD)|0.3||||0.52|TWO_SIDED|95.0|-0.5|1.1|||Regression, Logistic|||The primary endpoint was analysed using a Bayesian logistic regression, including as covariates the treatment arm, age (\<50 vs. ≥50), and a random effect for site||1.1|-0.5|0.52
71085342|NCT00676403|141676633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|10.54||0.653||95.0|-25.5|16.0|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.0|-25.5|0.6530
71123014|NCT00996801|141751519|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|58.57|||<|0.001|TWO_SIDED|95.0|29.42|88.04||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||88.04|29.42|<0.001
71123015|NCT00996801|141751519|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|57.07|||<|0.001|TWO_SIDED|95.0|30.76|83.64||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||83.64|30.76|<0.001
71123016|NCT00996801|141751519|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|95.34|||<|0.001|TWO_SIDED|95.0|60.4|130.91||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||130.91|60.40|<0.001
71085343|NCT00676403|141676633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|10.79||0.6263||95.0|-26.5|16.0|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.0|-26.5|0.6263
71085344|NCT00676403|141676633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.5|STANDARD_ERROR_OF_MEAN|10.63||0.4266||95.0|-29.4|12.5|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||12.5|-29.4|0.4266
71085345|NCT00676403|141676633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|10.54||0.4023||95.0|-29.6|11.9|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.9|-29.6|0.4023
71085346|NCT00676403|141676633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.6|STANDARD_ERROR_OF_MEAN|10.77||0.1041||95.0|-38.8|3.6|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.6|-38.8|0.1041
71085347|NCT00676403|141676633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|10.6||0.5084||95.0|-27.9|13.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.8|-27.9|0.5084
71085348|NCT00676403|141676633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.5|STANDARD_ERROR_OF_MEAN|11.1||0.262||95.0|-34.3|9.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.4|-34.3|0.2620
71123017|NCT00996801|141751520|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|53.86|||<|0.001|TWO_SIDED|95.0|39.31|68.6||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||68.60|39.31|<0.001
71123018|NCT00996801|141751520|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|53.81|||<|0.001|TWO_SIDED|95.0|41.37|66.38||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||66.38|41.37|<0.001
71123019|NCT00996801|141751520|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|55.47|||<|0.001|TWO_SIDED|95.0|41.19|69.94||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||69.94|41.19|<0.001
71123020|NCT00996801|141751520|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|20.53||||0.009|TWO_SIDED|95.0|5.96|35.03||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||35.03|5.96|0.009
71123021|NCT00996801|141751520|SUPERIORITY_OR_OTHER||Difference in Least Mean Squares|20.47||||0.009|TWO_SIDED|95.0|5.96|35.03||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||35.03|5.96|0.009
70856557|NCT01848782|141199751|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.8|TWO_SIDED|95.0|-0.6|0.5|||Mixed Models Analysis|||||0.5|-0.6|0.8
70856558|NCT01848782|141199752|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.2|TWO_SIDED|95.0|-1.0|0.2|||Mixed Models Analysis|||||0.2|-1.0|0.2
70856559|NCT02047318|141199761|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in sBA levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|-94.4|STANDARD_DEVIATION|98.915||0.0012|TWO_SIDED|95.0|-145.26|-43.55||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in sBA levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||-43.55|-145.26|0.0012
70856560|NCT02047318|141199762|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in sBA levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|-141.94|STANDARD_DEVIATION|117.992||0.032|TWO_SIDED|95.0|-265.77|-18.12||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in sBA levels was observed over time (with Week 252 chosen as the end point, as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||-18.12|-265.77|0.032
70856561|NCT02047318|141199763|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in sBA levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|-1.095|STANDARD_DEVIATION|0.7173|<|0.0001|TWO_SIDED|95.0|-1.464|-0.726||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ItchRO(Obs) scores was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||-0.726|-1.464|< 0.0001
70944850|NCT04333732|141390352|SUPERIORITY||Risk Difference (RD)|0.04||||0.95|TWO_SIDED|95.0|-1.4|1.3|||Regression, Logistic|difference, 0·04%, 95% CI, -1·4% to 1·3%, p=0·95).||The endpoint was analysed using a Bayesian logistic regression, including as covariates the treatment arm, age (\<50 vs. ≥50), and a random effect for site||1.3|-1.4|0.95
70944851|NCT04190225|141390364|SUPERIORITY||Median Difference (Final Values)|18.4||||0.04|TWO_SIDED|95.0|4.67|37.28|||quantile regression||Median difference is not the difference in the two medians, but is the median of differences between groups (why it is 18.4 and not 23)|||37.28|4.67|0.04
70944852|NCT04190225|141390365|SUPERIORITY||Median Difference (Final Values)|23.5||||0.03|TWO_SIDED|95.0|8.35|32.76|||quantile regression|||||32.76|8.35|0.03
70944853|NCT00477464|141390393|SUPERIORITY_OR_OTHER||percentage of participants|59.0|||||TWO_SIDED|95.0|44.2|72.4|||||The estimated value represents the percentage of participants who achieved a best overall response of complete response, partial response, or stable disease.|||72.4|44.2|
70856562|NCT02047318|141199764|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ItchRO(Obs) scores from baseline over time (to Week 158) was statistically significant.|Mean Difference (Net)|-0.958|STANDARD_DEVIATION|0.7868||0.0307|TWO_SIDED|95.0|-1.784|-0.132||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 158 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ItchRO(Obs) scores was observed over time (with Week 158 chosen as the end point, as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||-0.132|-1.784|0.0307
71123022|NCT00996801|141751520|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|22.13||||0.009|TWO_SIDED|95.0|4.47|39.89||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||39.89|4.47|0.009
71123023|NCT03369431|141751535|SUPERIORITY|||||||0.784|||||||t-test, 2 sided|||"Null hypothesis is that there is no difference in the percentage change from baseline in the ATEC Total between Vivomixx and Placebo.~A sample size of 72 participants was needed to determine an effect size of 0.50 with 80% power, with a type 1 error of 5% using a two-sided test. This calculation is based on the assumed effect size of the primary outcome measure, the ATEC. The minimally clinically important difference based on the primary outcome measure with this instrument was 15 points."||||0.784
71123024|NCT03369431|141751536|SUPERIORITY|||||||0.357|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in frequency of Abdominal Pain between Vivomixx and Placebo.||||0.357
71123025|NCT03369431|141751536|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in frequency of Gaseousness between Vivomixx and Placebo.||||0.290
71123026|NCT03369431|141751536|SUPERIORITY|||||||0.418|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in frequency of Diarrhoea between Vivomixx and Placebo.||||0.418
71123027|NCT03369431|141751536|SUPERIORITY|||||||0.734|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in frequency of Constipation between Vivomixx and Placebo.||||0.734
71123028|NCT03369431|141751536|SUPERIORITY|||||||0.362|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in frequency of Pain on Stooling between Vivomixx and Placebo.||||0.362
71123029|NCT03369431|141751536|SUPERIORITY|||||||0.705|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in frequency of Difficulty Swallowing between Vivomixx and Placebo.||||0.705
70944854|NCT00863798|141390415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86||||0.175|TWO_SIDED|95.0|-0.38|2.1||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|ANCOVA|||An analysis of covariance (ANCOVA) model with treatment and as a factor and the baseline HAM-D17 total score as a covariate was used to compare DVS SR 10 mg to placebo. The comparison was performed at the 0.05 level overall.||2.10|-0.38|0.175
71123030|NCT03369431|141751536|SUPERIORITY|||||||0.589|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in change from baseline in frequency of vomiting between Vivomixx and placebo||||0.589
71123031|NCT03369431|141751536|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon signed rank||Null hypothesis is that there is no difference in change from baseline in frequency of blood in stool between Vivomixx and placebo||||1.0
71123032|NCT03369431|141751536|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon signed rank||Null hypothesis is that there is no difference in change from baseline in frequency of blood in vomit between Vivomixx and placebo||||1.0
71123033|NCT03369431|141751537|SUPERIORITY|||||||0.635|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline of ABC Irritability score between Vivomixx and Placebo||||0.635
71123034|NCT03369431|141751537|SUPERIORITY|||||||0.367|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||The null hypothesis is that there is no difference in the change from baseline of ABC Lethargy/social withdrawal score between Vivomixx and Placebo.||||0.367
71123035|NCT03369431|141751537|SUPERIORITY|||||||0.609|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in the ABC Stereotypic behaviour between Vivomixx and Placebo.||||0.609
71123036|NCT03369431|141751537|SUPERIORITY|||||||0.805|||||||t-test, 2 sided|Paired samples t-test||Null hypothesis is that there is no difference in the change from baseline of the ABC Hyperactivity/Noncompliance between Vivomixx and Placebo.||||0.805
71123037|NCT03369431|141751537|SUPERIORITY|||||||0.985|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank test used.||Null hypothesis is that there is no difference in the change from baseline of the ABC Inappropriate Speech between Vivomixx and Placebo.||||0.985
71085349|NCT00676403|141676633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.3|STANDARD_ERROR_OF_MEAN|10.7||0.3347||95.0|-31.4|10.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.7|-31.4|0.3347
71085350|NCT00676403|141676633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.8|STANDARD_ERROR_OF_MEAN|10.61||0.1142||95.0|-37.7|4.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.1|-37.7|0.1142
71085351|NCT00676403|141676633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.1|STANDARD_ERROR_OF_MEAN|11.06||0.1237||95.0|-38.8|4.7|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.7|-38.8|0.1237
71085352|NCT00676403|141676633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|10.67||0.8302||95.0|-18.7|23.3|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.3|-18.7|0.8302
71085353|NCT00676403|141676633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|11.22||0.3039||95.0|-33.6|10.5|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.5|-33.6|0.3039
71085354|NCT00676403|141676633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.0|STANDARD_ERROR_OF_MEAN|10.77||0.4595||95.0|-29.2|13.2|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.2|-29.2|0.4595
71085355|NCT00676403|141676633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.6|STANDARD_ERROR_OF_MEAN|10.97||0.4338||95.0|-30.2|13.0|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.0|-30.2|0.4338
71085356|NCT00676403|141676633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.4|STANDARD_ERROR_OF_MEAN|10.99||0.0647||95.0|-42.0|1.2|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.2|-42.0|0.0647
71085357|NCT00676403|141676633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|10.61||0.5651||95.0|-27.0|14.8|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.8|-27.0|0.5651
71085358|NCT00676403|141676633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.6|STANDARD_ERROR_OF_MEAN|11.16||0.1634||95.0|-37.6|6.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||6.4|-37.6|0.1634
71123038|NCT03369431|141751538|SUPERIORITY|||||||0.661|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||||||0.661
71123039|NCT00046930|141751542|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28||95.0|||||Log Rank|Stratified on age (\< 70 vs. \>=70) and type of leukemia (de novo AML, secondary RAEB-t, or secondary RAEB AML)||The study was designed to have 80% power to detect a non-proportional hazards difference in OS at the one-sided 0.025 significance level of 30.2% vs 39.6%, 12.8% vs 27.1% and 7.0% vs 14.0% at 1 years, 2 years, and full information for zosuquidar and placebo, respectively.||||0.28
71123040|NCT00046930|141751543|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16||95.0|||||Log Rank|Stratified on age and type of leukemia||||||0.16
71123041|NCT00046930|141751544|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.617|TWO_SIDED|95.0|0.77|1.65||Test was stratified on age and type of leukemia.|Mantel Haenszel||Zosuquidar/Placebo|Test of difference in the CR (complete remission) rate between the arms.||1.65|0.77|0.617
71123042|NCT02317809|141751551|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Geometric least squares (LS) mean ratio|114.45|||||TWO_SIDED|90.0|110.87|118.15|||||Percentage of geometric LS mean ratio was presented.|Mixed model analysis was used.||118.15|110.87|
71123043|NCT02317809|141751552|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric least squares (LS) mean ratio|106.99|||||TWO_SIDED|90.0|101.42|112.86|||||Percentage of geometric LS mean ratio was presented.|Mixed model analysis was used.||112.86|101.42|
70856563|NCT02047318|141199767|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ALP levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|7.4|STANDARD_DEVIATION|210.32||0.8863|TWO_SIDED|95.0|-100.7|115.6||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ALP levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||115.6|-100.7|0.8863
71085359|NCT00676403|141676633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.2|STANDARD_ERROR_OF_MEAN|10.77||0.2209||95.0|-34.4|8.0|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.0|-34.4|0.2209
71085360|NCT00676403|141676633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.5|STANDARD_ERROR_OF_MEAN|10.84||0.1293||95.0|-37.8|4.8|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.8|-37.8|0.1293
71085361|NCT00676403|141676633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.8|STANDARD_ERROR_OF_MEAN|11.06||0.0161||95.0|-48.5|-5.0|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-5.0|-48.5|0.0161
71085362|NCT00676403|141676633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|10.67||0.8506||95.0|-23.0|19.0|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||19.0|-23.0|0.8506
71085363|NCT00676403|141676633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-30.9|STANDARD_ERROR_OF_MEAN|11.31||0.0067||95.0|-53.2|-8.6|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-8.6|-53.2|0.0067
71085364|NCT00676403|141676633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.8|STANDARD_ERROR_OF_MEAN|10.76||0.1997||95.0|-35.0|7.4|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.4|-35.0|0.1997
71085365|NCT00676403|141676633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.4|STANDARD_ERROR_OF_MEAN|10.9||0.0159||95.0|-47.9|-5.0|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-5.0|-47.9|0.0159
71123044|NCT02317809|141751553|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric least squares (LS) mean ratio|112.67|||||TWO_SIDED|90.0|106.44|119.27|||||Percentage of geometric LS mean ratio was presented.|Mixed model analysis was used.||119.27|106.44|
71123045|NCT02317809|141751554|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Geometric least squares (LS) mean ratio|103.27|||||TWO_SIDED|90.0|93.16|114.47|||||Percentage of geometric LS mean ratio was presented.|Mixed model analysis was used.||114.47|93.16|
71123046|NCT06504524|141751575|OTHER||Hazard Ratio (HR)|1.128|||=|0.615|TWO_SIDED|95.0|0.705|1.804|||Regression, Cox||IPTW hazard ratio (HR) were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||1.804|0.705|=0.615
71123047|NCT06504524|141751576|OTHER||Hazard Ratio (HR)|1.18|||=|0.4429|TWO_SIDED|95.0|0.85|1.64|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||1.64|0.85|=0.4429
71123048|NCT06504524|141751577|OTHER||Hazard Ratio (HR)|0.66|||=|0.12|TWO_SIDED|95.0|0.39|1.115|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||1.115|0.390|=0.120
71123049|NCT06504524|141751578|OTHER||Hazard Ratio (HR)|0.52|||=|0.0011|TWO_SIDED|95.0|0.38|0.71|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||0.71|0.38|=0.0011
71123050|NCT06504524|141751579|OTHER||Hazard Ratio (HR)|0.759|||=|0.503|TWO_SIDED|95.0|0.337|1.71|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||1.710|0.337|=0.503
71123051|NCT06504524|141751580|OTHER||Hazard Ratio (HR)|0.38|||<|0.0001|TWO_SIDED|95.0|0.26|0.57|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||0.57|0.26|<0.0001
71123052|NCT06504524|141751581|OTHER||Hazard Ratio (HR)|0.918|||=|0.706|TWO_SIDED|95.0|0.587|1.436|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||1.436|0.587|=0.706
71123053|NCT06504524|141751582|OTHER||Hazard Ratio (HR)|0.68|||=|0.0182|TWO_SIDED|95.0|0.52|0.88|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||0.88|0.52|=0.0182
71123054|NCT03458702|141751604|EQUIVALENCE|It would be expected at baseline that there were no differences between groups.|||||>|0.05|||||||t-test, 2 sided|||||||>.05
71123055|NCT03458702|141751604|SUPERIORITY||||||<|0.001|||||||ANOVA|||ANOVA for TIME||||<0.001
71123056|NCT03458702|141751605|EQUIVALENCE|It would be expected at baseline there would be no difference between groups.|||||>|0.05|||||||ANOVA|||||||>.05
71123057|NCT03458702|141751605|SUPERIORITY||||||<|0.001|||||||ANOVA|||ANOVA: Condition x Time Interaction||||<0.001
71123058|NCT03458702|141751605|SUPERIORITY|||||||0.005|||||||ANOVA|||ANOVA: TIME||||0.005
71123059|NCT03458702|141751606|EQUIVALENCE|It would be hypothesized that there would not be a difference at baseline.|||||>|0.05|||||||ANOVA|||||||> .05
71123060|NCT03458702|141751606|SUPERIORITY|||||||0.042|||||||ANOVA|||ANOVA: CONDITION X TIME INTERACTION||||0.042
71123061|NCT03458702|141751606|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||ANOVA: TIME||||<0.001
71123062|NCT03458702|141751607|EQUIVALENCE|A difference at baseline was not expected.|||||>|0.05|||||||ANOVA|||||||>.05
71123063|NCT03458702|141751607|SUPERIORITY|||||||0.016|||||||ANOVA|||ANOVA: TIME||||0.016
71123064|NCT03458702|141751608|EQUIVALENCE|no difference is expected at baseline|||||>|0.05|||||||ANOVA|||||||>.05
71123065|NCT03458702|141751608|SUPERIORITY|||||||0.026|||||||ANOVA|||ANOVA:TIME||||0.026
71123066|NCT03458702|141751609|SUPERIORITY||||||<|0.05|||||||t-test, 1 sided|||||||<.05
71123067|NCT01394614|141751657|SUPERIORITY_OR_OTHER||Incidence-rate difference|0.41|||||TWO_SIDED||||||||Difference between the incidence rate of exposed-to-vaccine cases (0.52) and that of unexposed cases (0.11) is 0.41 per 100,000 persons-years|||||
71123068|NCT01394614|141751657|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|4.32|||||TWO_SIDED|95.0|1.5|11.12|||||Risk of developing narcolepsy if exposed to H1N1 vaccination (using the 16-week post-vaccination period as reference).|||11.12|1.5|
71123069|NCT01149486|141751658|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|93.45|||||TWO_SIDED|90.0|80.2|108.88|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.88|80.20|
71123070|NCT01149486|141751659|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.45|||||TWO_SIDED|90.0|93.15|106.18|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||106.18|93.15|
71123071|NCT01149486|141751660|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.4|||||TWO_SIDED|90.0|93.1|106.12|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||106.12|93.10|
71123072|NCT01149486|141751661|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|111.62|||||TWO_SIDED|90.0|101.47|122.79|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||122.79|101.47|
71123073|NCT01149486|141751662|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.8|||||TWO_SIDED|90.0|99.58|112.41|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||112.41|99.58|
71123074|NCT01149486|141751663|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.55|||||TWO_SIDED|90.0|99.64|111.82|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||111.82|99.64|
71085366|NCT00676403|141676633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.8|STANDARD_ERROR_OF_MEAN|10.98||0.0388||95.0|-44.4|-1.2|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-1.2|-44.4|0.0388
71085367|NCT00676403|141676633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|10.73||0.9962||95.0|-21.2|21.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||21.1|-21.2|0.9962
71085368|NCT00676403|141676633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.8|STANDARD_ERROR_OF_MEAN|11.41||0.0839||95.0|-42.3|2.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||2.7|-42.3|0.0839
71085369|NCT00676403|141676633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|10.83||0.5216||95.0|-28.3|14.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.4|-28.3|0.5216
71085370|NCT00676403|141676633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-21.3|STANDARD_ERROR_OF_MEAN|10.98||0.0534||95.0|-42.9|0.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-42.9|0.0534
71123075|NCT01149486|141751664|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.78|||||TWO_SIDED|90.0|98.96|115.23|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||115.23|98.96|
71123076|NCT01149486|141751665|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.37|||||TWO_SIDED|90.0|98.75|106.14|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||106.14|98.75|
71123077|NCT01149486|141751666|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.3|||||TWO_SIDED|90.0|98.72|106.01|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||106.01|98.72|
71123078|NCT02312765|141751717|SUPERIORITY|||||||0.72|||||||Chi-squared|||||||0.72
71123079|NCT04375397|141751718|SUPERIORITY||Adjusted risk difference (%)|5.8|||=|0.599|TWO_SIDED|80.0|-9.2|20.4|||Miettinen-Nurminen method||Ibrutinib 420 mg + SOC - Placebo + SOC Miettinen-Nurminen (MN) CI for the adjusted risk difference across strata|The difference in response rates between the experimental arm and the control arm were analyzed using the Miettinen-Nurminen (MN) method, adjusting for the stratification factor of prescription for remdesivir. The MN test p-value for testing the rate difference = 0 at two-sided alpha = 0.2.||20.4|-9.2|=0.599
71123080|NCT04375397|141751718|SUPERIORITY||Adjusted risk difference (%)|5.8|||=|0.599|TWO_SIDED|95.0|-18.1|28.7|||Miettinen-Nurminen method||Ibrutinib 420 mg + SOC - Placebo + SOC Miettinen-Nurminen (MN) CI for the adjusted risk difference across strata|The difference in response rates between the experimental arm and the control arm were analyzed using the Miettinen-Nurminen (MN) method, adjusting for the stratification factor of prescription for remdesivir. The MN test p-value for testing the rate difference = 0 at twosided alpha = 0.2.||28.7|-18.1|=0.599
71123081|NCT04375397|141751719|SUPERIORITY||Odds Ratio (OR)|1.17|||=|0.886|TWO_SIDED|95.0|0.13|10.44|||Multinomial Logistic Regression|||"Change in ordinal score from baseline to day 14 = -3~To evaluate the odds of clinical status improvement as determined by the WHO-8 ordinal scale, a multinomial logistic regression model was used.~Pairwise Comparison in Reference to the Group with Change = -4"||10.44|0.13|=0.886
71123082|NCT04375397|141751719|SUPERIORITY||Odds Ratio (OR)|0.64|||=|0.705|TWO_SIDED|95.0|0.06|6.43|||Multinomial Logistic Regression|||"Change in ordinal score from baseline to day 14 = -2~To evaluate the odds of clinical status improvement as determined by the WHO-8 ordinal scale, a multinomial logistic regression model was used.~Pairwise Comparison in Reference to the Group with Change = -4"||6.43|0.06|=0.705
71123083|NCT04375397|141751719|SUPERIORITY||Odds Ratio (OR)|0.0|||=|0.996|TWO_SIDED|95.0|0.0||The upper limit of this 95% CI is infinite.||Multinomial Logistic Regression|||"Change in ordinal score from baseline to day 14 = -1~To evaluate the odds of clinical status improvement as determined by the WHO-8 ordinal scale, a multinomial logistic regression model was used.~Pairwise Comparison in Reference to the Group with Change = -4"|||0.00|=0.996
71123084|NCT04375397|141751719|SUPERIORITY||Odds Ratio (OR)|1.07|||=|0.969|TWO_SIDED|95.0|0.04|32.18|||Multinomial Logistic Regression|||"Change in ordinal score from baseline to day 14 = 0~To evaluate the odds of clinical status improvement as determined by the WHO-8 ordinal scale, a multinomial logistic regression model was used.~Pairwise Comparison in Reference to the Group with Change = -4"||32.18|0.04|=0.969
71123085|NCT04375397|141751719|SUPERIORITY||Odds Ratio (OR)|1.07|||=|0.969|TWO_SIDED|95.0|0.04|32.18|||Multinomial Logistic Regression|||"Change in ordinal score from baseline to day 14 = 1~To evaluate the odds of clinical status improvement as determined by the WHO-8 ordinal scale, a multinomial logistic regression model was used.~Pairwise Comparison in Reference to the Group with Change = -4"||32.18|0.04|=0.969
71123086|NCT04375397|141751719|SUPERIORITY||Odds Ratio (OR)|1.07|||=|0.969|TWO_SIDED|95.0|0.04|32.18|||Multinomial Logistic Regression|||"Change in ordinal score from baseline to day 14 = 3~To evaluate the odds of clinical status improvement as determined by the WHO-8 ordinal scale, a multinomial logistic regression model was used.~Pairwise Comparison in Reference to the Group with Change = -4"||32.18|0.04|=0.969
71123087|NCT04375397|141751720|SUPERIORITY||Difference in Medians|-1.5|||=|0.801|TWO_SIDED||||||Van Elteren's test||Ibrutinib 420 mg + SOC - Placebo + SOC|Median days spent on supplemental oxygen was compared between treatment groups using Van Elteren's test with the stratification factor of prescription for remdesivir.||||=0.801
71123088|NCT04375397|141751721|SUPERIORITY||Mortality rate difference|0.0|||=|1|TWO_SIDED|80.0|-6.7|7.3|||Miettinen-Nurminen|||"At Day 7-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||7.3|-6.7|=1.000
71123089|NCT04375397|141751721|SUPERIORITY||Mortality rate difference|0.0|||=|1|TWO_SIDED|95.0|-14.4|15.5|||Miettinen-Nurminen|||"At Day 7-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||15.5|-14.4|=1.000
71123090|NCT04375397|141751721|SUPERIORITY||Mortality rate difference|0.0|||=|1|TWO_SIDED|80.0|-6.7|7.3|||Miettinen-Nurminen|||"At Day 14-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||7.3|-6.7|=1.000
71123091|NCT04375397|141751721|SUPERIORITY||Mortality rate difference|0.0|||=|1|TWO_SIDED|95.0|-14.4|15.5|||Miettinen-Nurminen|||"At Day 14-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||15.5|-14.4|=1.000
71123092|NCT04375397|141751721|SUPERIORITY||Mortality rate difference|4.8|||=|0.267|TWO_SIDED|80.0|-1.7|14.8|||Miettinen-Nurminen|||"At Day 21-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||14.8|-1.7|=0.267
71123093|NCT04375397|141751721|SUPERIORITY||Mortality rate difference|4.8|||=|0.267|TWO_SIDED|95.0|-9.6|22.8|||Miettinen-Nurminen|||"At Day 21-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||22.8|-9.6|=0.267
71123094|NCT04375397|141751721|SUPERIORITY||Mortality rate difference|4.8|||=|0.267|TWO_SIDED|80.0|-1.7|14.8|||Miettinen-Nurminen|||"At Day 28-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||14.8|-1.7|=0.267
71123095|NCT04375397|141751721|SUPERIORITY||Mortality rate difference|4.8|||=|0.267|TWO_SIDED|95.0|-9.6|22.8|||Miettinen-Nurminen|||"At Day 28-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||22.8|-9.6|=0.267
71123096|NCT04375397|141751722|SUPERIORITY||Adjusted risk difference (%)|-10.7|||=|0.314|TWO_SIDED|80.0|-24.8|3.3|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 7~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||3.3|-24.8|=0.314
71123097|NCT04375397|141751722|SUPERIORITY||Adjusted risk difference (%)|-10.7|||=|0.314|TWO_SIDED|95.0|-32.8|12.0|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 7~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||12.0|-32.8|=0.314
71123098|NCT04375397|141751722|SUPERIORITY||Adjusted risk difference (%)|-10.7|||=|0.314|TWO_SIDED|80.0|-24.8|3.3|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 14~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||3.3|-24.8|=0.314
71085371|NCT00676403|141676634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.8|STANDARD_ERROR_OF_MEAN|5.89||0.0199||95.0|2.2|25.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||25.4|2.2|0.0199
71123099|NCT04375397|141751722|SUPERIORITY||Adjusted risk difference (%)|-10.7|||=|0.314|TWO_SIDED|95.0|-32.8|12.0|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 14~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||12.0|-32.8|=0.314
71123100|NCT04375397|141751722|SUPERIORITY||Adjusted risk difference (%)|-5.8|||=|0.599|TWO_SIDED|80.0|-20.4|9.2|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 21~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||9.2|-20.4|=0.599
71123101|NCT04375397|141751722|SUPERIORITY||Adjusted risk difference (%)|-5.8|||=|0.599|TWO_SIDED|95.0|-28.7|18.1|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 21~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||18.1|-28.7|=0.599
71123102|NCT04375397|141751722|SUPERIORITY||Adjusted risk difference (%)|-5.8|||=|0.599|TWO_SIDED|80.0|-20.4|9.2|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 28~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||9.2|-20.4|=0.599
71123103|NCT04375397|141751722|SUPERIORITY||Adjusted risk difference (%)|-5.8|||=|0.599|TWO_SIDED|95.0|-28.7|18.1|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 28~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||18.1|-28.7|=0.599
71123104|NCT04375397|141751723|SUPERIORITY||||||=|0.851|||||||Log Rank|||For the analysis of mechanical ventilation-free survival, the distribution of time to event was estimated by treatment group using Kaplan-Meier methodology and compared between the experimental arm and the control arm using the log-rank test stratified by prescription for remdesivir.||||=0.851
71123105|NCT04375397|141751724|SUPERIORITY||Difference in Medians|0.0|||=|0.745|TWO_SIDED||||||Van Elteren's test||Ibrutinib 420 mg + SOC - Placebo + SOC|Median days spent on mechanical ventilation were compared between treatment groups using Van Elteren's test with the stratification factor of prescription for remdesivir.||||=0.745
71123106|NCT04375397|141751725|SUPERIORITY||Difference in Medians|-0.5|||=|0.977|TWO_SIDED||||||Van Elteren's test]||Ibrutinib 420 mg + SOC - Placebo + SOC|Median duration of hospitalization was compared between treatment groups using Van Elteren's test with the stratification factor of prescription for remdesivir.||||=0.977
71123107|NCT04375397|141751726|SUPERIORITY||||||=|0.969|||||||Log Rank|||For the analysis of time to discharge from hospital, the distribution of time to event was estimated by treatment group using Kaplan-Meier methodology and compared between the experimental arm and the control arm using the log-rank test stratified by prescription for remdesivir.||||=0.969
71085372|NCT00676403|141676634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.3|STANDARD_ERROR_OF_MEAN|5.78||0.0768||95.0|-1.1|21.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||21.7|-1.1|0.0768
71085373|NCT00676403|141676634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|5.91||0.0642||95.0|-0.7|22.6|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||22.6|-0.7|0.0642
71123108|NCT00610441|141751734|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.6996||||0.0147|TWO_SIDED|97.5|-10.911|-0.4881||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|Mixed Model for Repeated Measurements||Mixed Model for Repeated Measurements (MMRM) with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline AISRS score as covariate.|The treatment difference between 100 mg MK-8777 fixed dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||-0.4881|-10.911|0.0147
71123109|NCT00610441|141751734|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9926||||0.591|TWO_SIDED|97.5|-3.2961|5.2814||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline AISRS score as covariate.|The treatment difference between 100-300 mg MK-8777 rising dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||5.2814|-3.2961|0.5910
71085374|NCT00676403|141676634|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|5.88||0.2643||95.0|-5.0|18.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.2|-5.0|0.2643
71085375|NCT00676403|141676634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.2|STANDARD_ERROR_OF_MEAN|5.8||0.0358||95.0|0.8|23.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.7|0.8|0.0358
71085376|NCT00676403|141676634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.1|STANDARD_ERROR_OF_MEAN|5.93||0.0428||95.0|0.4|23.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.8|0.4|0.0428
71085377|NCT00676403|141676634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.5|STANDARD_ERROR_OF_MEAN|5.81||0.1993||95.0|-4.0|18.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.9|-4.0|0.1993
70856564|NCT02047318|141199768|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ALP levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|-184.3|STANDARD_DEVIATION|322.22||0.22|TWO_SIDED|95.0|-522.5|153.8||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ALP levels was observed over time (with Week 252 chosen as the end point as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||153.8|-522.5|0.22
71085378|NCT00676403|141676634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.9|STANDARD_ERROR_OF_MEAN|6.04||0.0331||95.0|1.1|24.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||24.8|1.1|0.0331
71085379|NCT00676403|141676634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.1|STANDARD_ERROR_OF_MEAN|5.91||0.0415||95.0|0.5|23.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.8|0.5|0.0415
71123110|NCT00610441|141751735|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.8506|||||TWO_SIDED|95.0|1.799|26.0878|||||Logistic regression with fixed effects for treatment and period, and baseline AISRS score as covariate.|||26.0878|1.7990|
71123111|NCT00610441|141751735|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9461|||||TWO_SIDED|95.0|0.3119|2.8701|||||Logistic regression with fixed effects for treatment and period, and baseline AISRS score as covariate.|||2.8701|0.3119|
71123112|NCT00610441|141751736|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.2468|||||TWO_SIDED|95.0|0.6712|58.1395|||||Since no participants in the Placebo group achieved a 50% reduction, the comparison was done using a Cochran-Mantel-Haenszel method and 0.5 was added to both groups.|||58.1395|0.6712|
71123113|NCT00610441|141751736|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1453|||||TWO_SIDED|95.0|0.0152|1.388|||||Logistic regression with fixed effects for treatment and period, and baseline AISRS score as covariate.|||1.3880|0.0152|
71123114|NCT00610441|141751739|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2074|||||TWO_SIDED|95.0|0.5654|2.5785|||||Proportional odds model with fixed effects for treatment and period.|||2.5785|0.5654|
71123115|NCT00610441|141751739|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8548|||||TWO_SIDED|95.0|0.6951|4.9494|||||Proportional odds model with fixed effects for treatment and period.|||4.9494|0.6951|
71085380|NCT00676403|141676634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.8|STANDARD_ERROR_OF_MEAN|5.83||0.0295||95.0|1.3|24.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||24.3|1.3|0.0295
71123116|NCT00610441|141751740|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3149|||||TWO_SIDED|95.0|0.5402|3.2008|||||Proportional odds model with fixed effects for treatment and period.|||3.2008|0.5402|
71123117|NCT00610441|141751740|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3982|||||TWO_SIDED|95.0|0.524|3.7309|||||Proportional odds model with fixed effects for treatment and period.|||3.7309|0.5240|
71123118|NCT00610441|141751741|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3163||||0.6155|TWO_SIDED|97.5|-1.8138|1.1812||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline ESS score as covariate. For statistical analyses, the average score from Days 14 and 21 was used.|The treatment difference between 100 mg MK-8777 fixed dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||1.1812|-1.8138|0.6155
71123119|NCT00610441|141751741|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2934||||0.133|TWO_SIDED|97.5|-0.7449|3.3317||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline ESS score as covariate. For statistical analyses, the average score from Days 14 and 21 was used.|The treatment difference between 100-300 mg MK-8777 rising dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||3.3317|-0.7449|0.1330
71123120|NCT00610441|141751742|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5501||||0.3907|TWO_SIDED|97.5|-0.9427|2.0429||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline PSQI score as covariate.|The treatment difference between 100 mg MK-8777 fixed dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||2.0429|-0.9427|0.3907
71085381|NCT00676403|141676634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.2|STANDARD_ERROR_OF_MEAN|6.01||0.1267||95.0|-2.6|21.1|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||21.1|-2.6|0.1267
71123121|NCT00610441|141751742|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0065||||0.9872|TWO_SIDED|97.5|-0.9486|0.9357||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline PSQI score as covariate.|The treatment difference between 100-300 mg MK-8777 rising dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||0.9357|-0.9486|0.9872
71085382|NCT00676403|141676634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|5.84||0.4175||95.0|-6.8|16.2|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.2|-6.8|0.4175
71085383|NCT00676403|141676634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.0|STANDARD_ERROR_OF_MEAN|6.09||0.0342||95.0|1.0|25.0|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||25.0|1.0|0.0342
71085384|NCT00676403|141676634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.7|STANDARD_ERROR_OF_MEAN|5.96||0.1038||95.0|-2.0|21.5|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||21.5|-2.0|0.1038
71085385|NCT00676403|141676634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.6|STANDARD_ERROR_OF_MEAN|5.98||0.0537||95.0|-0.2|23.4|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.4|-0.2|0.0537
71085386|NCT00676403|141676634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.6|STANDARD_ERROR_OF_MEAN|5.99||0.0772||95.0|-1.2|22.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||22.4|-1.2|0.0772
71085387|NCT00676403|141676634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.8|STANDARD_ERROR_OF_MEAN|5.81||0.1296||95.0|-2.6|20.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||20.3|-2.6|0.1296
71085388|NCT00676403|141676634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.0|STANDARD_ERROR_OF_MEAN|6.06||0.014||95.0|3.1|27.0|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||27.0|3.1|0.0140
71085389|NCT00676403|141676634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|5.93||0.0642||95.0|-0.7|22.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||22.7|-0.7|0.0642
71085390|NCT00676403|141676634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.7|STANDARD_ERROR_OF_MEAN|5.92||0.073||95.0|-1.0|22.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||22.3|-1.0|0.0730
71085391|NCT00676403|141676634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.9|STANDARD_ERROR_OF_MEAN|6.01||0.0215||95.0|2.1|25.8|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||25.8|2.1|0.0215
71085392|NCT00676403|141676634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|5.84||0.3785||95.0|-6.4|16.7|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.7|-6.4|0.3785
70872012|NCT00790023|141229440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08|||<|0.0001|TWO_SIDED|95.0|0.7|1.45||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in rTNSS with a two-sided alpha level of 0.025.||1.45|0.70|<0.0001
71085393|NCT00676403|141676634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|16.1|STANDARD_ERROR_OF_MEAN|6.12||0.0089||95.0|4.1|28.2|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||28.2|4.1|0.0089
71085394|NCT00676403|141676634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.2|STANDARD_ERROR_OF_MEAN|5.96||0.0609||95.0|-0.5|23.0|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.0|-0.5|0.0609
71085395|NCT00676403|141676634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|16.4|STANDARD_ERROR_OF_MEAN|5.95||0.0064||95.0|4.7|28.1|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||28.1|4.7|0.0064
71085396|NCT00676403|141676634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.7|STANDARD_ERROR_OF_MEAN|6.01||0.0241||95.0|1.8|25.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||25.5|1.8|0.0241
71085397|NCT00676403|141676634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.6|STANDARD_ERROR_OF_MEAN|5.86||0.1032||95.0|-2.0|21.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||21.1|-2.0|0.1032
71085398|NCT00676403|141676634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|16.6|STANDARD_ERROR_OF_MEAN|6.16||0.0076||95.0|4.4|28.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||28.7|4.4|0.0076
71085399|NCT00676403|141676634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.2|STANDARD_ERROR_OF_MEAN|5.96||0.1257||95.0|-2.6|20.9|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||20.9|-2.6|0.1257
71085400|NCT00676403|141676634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.9|STANDARD_ERROR_OF_MEAN|5.95||0.0131||95.0|3.2|26.6|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||26.6|3.2|0.0131
71085401|NCT00676403|141676635|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.3|STANDARD_ERROR_OF_MEAN|6.94||0.1824||95.0|-23.0|4.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.4|-23.0|0.1824
71123122|NCT00610441|141751743|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1543||||0.7828|TWO_SIDED|97.5|-1.4898|1.1811||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline QIDS-C score as covariate. Scores from Days 14 and 21 were averaged for statistical analyses.|The treatment difference between 100 mg MK-8777 fixed dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||1.1811|-1.4898|0.7828
71085402|NCT00676403|141676635|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.1|STANDARD_ERROR_OF_MEAN|6.8||0.0767||95.0|-25.5|1.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.3|-25.5|0.0767
71085403|NCT00676403|141676635|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.1|STANDARD_ERROR_OF_MEAN|7.11||0.0492||95.0|-28.1|-0.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.1|-28.1|0.0492
70856565|NCT02047318|141199769|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ALT levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|51.6|STANDARD_DEVIATION|89.77||0.0307|TWO_SIDED|95.0|5.4|97.7||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ALT levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||97.7|5.4|0.0307
71085404|NCT00676403|141676635|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.7|STANDARD_ERROR_OF_MEAN|6.84||0.2023||95.0|-22.2|4.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.7|-22.2|0.2023
71085405|NCT00676403|141676635|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.4|STANDARD_ERROR_OF_MEAN|6.83||0.0116||95.0|-30.9|-3.9|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-3.9|-30.9|0.0116
71085406|NCT00676403|141676635|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.4|STANDARD_ERROR_OF_MEAN|7.01||0.1819||95.0|-23.2|4.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.4|-23.2|0.1819
71085407|NCT00676403|141676635|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|6.76||0.2806||95.0|-20.6|6.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||6.0|-20.6|0.2806
71085408|NCT00676403|141676635|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|7.13||0.1465||95.0|-24.4|3.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.7|-24.4|0.1465
71085409|NCT00676403|141676635|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.6|STANDARD_ERROR_OF_MEAN|6.85||0.0046||95.0|-33.1|-6.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-6.1|-33.1|0.0046
71085410|NCT00676403|141676635|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.4|STANDARD_ERROR_OF_MEAN|6.92||0.0187||95.0|-30.0|-2.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-2.8|-30.0|0.0187
71085411|NCT00676403|141676635|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.5|STANDARD_ERROR_OF_MEAN|7.0||0.6128||95.0|-10.2|17.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||17.3|-10.2|0.6128
71085412|NCT00676403|141676635|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.4|STANDARD_ERROR_OF_MEAN|6.76||0.3488||95.0|-19.7|7.0|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.0|-19.7|0.3488
71123123|NCT00610441|141751743|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4222||||0.2883|TWO_SIDED|97.5|-0.5187|1.363||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline QIDS-C score as covariate. Scores from Days 14 and 21 were averaged for statistical analyses.|The treatment difference between 100-300 mg MK-8777 rising dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||1.3630|-0.5187|0.2883
70944855|NCT00863798|141390415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.51||||0.421|TWO_SIDED|95.0|-0.73|1.75||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|ANCOVA|||An analysis of covariance (ANCOVA) model with treatment and as a factor and the baseline HAM-D17 total score as a covariate was used to compare DVS SR 10 mg to placebo. The comparison was performed at the 0.05 level overall.||1.75|-0.73|0.421
70944856|NCT00863798|141390416|SUPERIORITY_OR_OTHER|||||||0.076|TWO_SIDED|||||In this case, multiplicity arising from testing key secondary hypotheses in both doses was controlled by a Hochberg step-up procedure. p-Value obtained for the alternative hypothesis of 'Row mean scores differences'.|Cochran-Mantel-Haenszel|||Each DVS SR dose was separately compared to placebo. To control the study-wise type I error rate across the primary and the key secondary endpoints, as well as across the 2 active dose arms, testing of the key secondary hypothesis occurred only when both active doses were superior to placebo on the primary endpoint.||||0.076
70944857|NCT00863798|141390416|SUPERIORITY_OR_OTHER|||||||0.204|TWO_SIDED|||||In this case, multiplicity arising from testing key secondary hypotheses in both doses was controlled by a Hochberg step-up procedure. p-Value obtained for the alternative hypothesis of 'Row mean scores differences'.|Cochran-Mantel-Haenszel|||Each DVS SR dose was separately compared to placebo. To control the study-wise type I error rate across the primary and the key secondary endpoints, as well as across the 2 active dose arms, testing of the key secondary hypothesis occurred only when both active doses were superior to placebo on the primary endpoint.||||0.204
70944858|NCT00863798|141390417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.13|TWO_SIDED|95.0|-0.04|0.35|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.35|-0.04|0.130
70944859|NCT00863798|141390417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.757|TWO_SIDED|95.0|-0.16|0.23|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.23|-0.16|0.757
70944860|NCT00863798|141390418|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.41||||0.114|TWO_SIDED|95.0|-0.34|3.16|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||3.16|-0.34|0.114
70944861|NCT00863798|141390418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.316|TWO_SIDED|95.0|-0.85|2.64|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||2.64|-0.85|0.316
70944862|NCT00863798|141390419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74||||0.054|TWO_SIDED|95.0|-0.01|1.5|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||1.50|-0.01|0.054
71123124|NCT00610441|141751744|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9685||||0.6532|TWO_SIDED|97.5|-5.9599|4.0229|||MMRM|To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline TASS score as covariate.|The treatment difference between 100 mg MK-8777 fixed dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||4.0229|-5.9599|0.6532
70872013|NCT00790023|141229441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.87|||<|0.0001|TWO_SIDED|95.0|0.5|1.25|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||1.25|0.50|<0.0001
70944863|NCT00863798|141390419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.253|TWO_SIDED|95.0|-0.32|1.2|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||1.20|-0.32|0.253
70944864|NCT00863798|141390420|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.254||||0.2415|TWO_SIDED|95.0|0.86|1.83|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||1.83|0.86|0.2415
70944865|NCT00863798|141390420|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.102||||0.6169|TWO_SIDED|95.0|0.75|1.61|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||1.61|0.75|0.6169
70944866|NCT00863798|141390421|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.236||||0.3667|TWO_SIDED|95.0|0.78|1.96|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||1.96|0.78|0.3667
70944867|NCT00863798|141390421|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.894||||0.6509|TWO_SIDED|95.0|0.55|1.45|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||1.45|0.55|0.6509
70944868|NCT00863798|141390422|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.182||||0.3893|TWO_SIDED|95.0|0.81|1.73|||Regression, Logistic|||Analysis would be conducted with a logistic regression model with treatment as a factor and baseline MADRS score as a covariate.||1.73|0.81|0.3893
70944869|NCT00863798|141390422|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.123||||0.551|TWO_SIDED|95.0|0.77|1.65|||Regression, Logistic|||Analysis would be conducted with a logistic regression model with treatment as a factor and baseline MADRS score as a covariate.||1.65|0.77|0.5510
70944870|NCT00863798|141390423|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.442||||0.0536|TWO_SIDED|95.0|0.99|2.09|||Regression, Logistic|||Analysis would be conducted with a logistic regression model with treatment as a factor.||2.09|0.99|0.0536
70944871|NCT00863798|141390423|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.085||||0.6679|TWO_SIDED|95.0|0.75|1.57|||Regression, Logistic|||Analysis would be conducted with a logistic regression model with treatment as a factor.||1.57|0.75|0.6679
70944872|NCT00863798|141390425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46||||0.033|TWO_SIDED|95.0|0.12|2.79|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for total score."||2.79|0.12|0.033
70944873|NCT00863798|141390425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.15||||0.096|TWO_SIDED|95.0|-0.2|2.49|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for total score."||2.49|-0.20|0.096
70944874|NCT00863798|141390425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48||||0.043|TWO_SIDED|95.0|0.02|0.95|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for work/studies component score."||0.95|0.02|0.043
70944875|NCT00863798|141390425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53||||0.027|TWO_SIDED|95.0|0.06|1.0|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for work/studies component score."||1.00|0.06|0.027
71085413|NCT00676403|141676635|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|7.17||0.1472||95.0|-24.5|3.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.7|-24.5|0.1472
71085414|NCT00676403|141676635|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|6.89||0.0791||95.0|-25.7|1.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.4|-25.7|0.0791
71085415|NCT00676403|141676635|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.4|STANDARD_ERROR_OF_MEAN|6.97||0.0282||95.0|-29.1|-1.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-1.7|-29.1|0.0282
71085416|NCT00676403|141676635|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.9|STANDARD_ERROR_OF_MEAN|7.08||0.1623||95.0|-23.9|4.0|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.0|-23.9|0.1623
71123125|NCT00610441|141751744|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1022||||0.5247|TWO_SIDED|97.5|-2.8951|5.0996||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline TASS score as covariate.|The treatment difference between 100-300 mg MK-8777 rising dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||5.0996|-2.8951|0.5247
71123126|NCT01173029|141751756|NON_INFERIORITY_OR_EQUIVALENCE|Study power calculation was post-hoc based on composite end-point achieved. Number of exposed: 62 Non-exposed to exposed ratio: 0.5 Relative risk worth detecting: 2.5 Attack rate among non-exposed: 23% Alpha risk: 0.05 Calculated power: 89.8%|Risk Ratio (RR)|1.7||||0.19|TWO_SIDED|95.0|0.7|4.1||not adjusted|Chi-squared, Corrected|1 degree-of-freedom||"Long-term intention-to-treat data analysis:~Student 't' tests Yates's corrected Chi-squared or Fisher's exact test, when appropriate Relative risk estimation Cox proportional-hazard model Hardy-Weinberg equilibrium"||4.1|0.7|0.19
71123127|NCT01173029|141751757|NON_INFERIORITY_OR_EQUIVALENCE|Study power calculation was post-hoc based on composite end-point achieved. Number of exposed: 62 Non-exposed to exposed ratio: 0.5 Relative risk worth detecting: 2.5 Attack rate among non-exposed: 23% Alpha risk: 0.05 Calculated power: 89.8%|Risk Ratio (RR)|2.6||||0.01|TWO_SIDED|95.0|1.01|7.3||not adjusted|Chi-squared, Corrected|1 degree-of-freedom||"Long-term intention-to-treat data analysis:~Student 't' test Yates' corrected Chi-squared or Fisher's exact test Relative risk estimation Cox proportional-hazard model Hardy-Weinberg equilibrium"||7.3|1.01|0.01
71123128|NCT01173029|141751757|NON_INFERIORITY_OR_EQUIVALENCE|Proportional-risk hypothesis was tested using the correlation between Schoenfeld's residuals and time (Schoenfeld's global test). The correlation rho was -0.08, Chi-squared was 0.12, and p was 0.73. Therefore, the hypothesis of proportional risk was accepted, validating the correct application model.|Hazard Ratio (HR)|2.2||||0.04|TWO_SIDED|95.0|1.1|4.8||The p-value was adjusted for confounders: Framingham risk score, body mass index, ethnic groups|Regression, Cox|The actuarial function of events per time since the first diagnosis of arterial hypertension was plotted for both groups.||Cox proportional hazard model for the composite endpoint (stroke + myocardial infarction) was assessed. By taking pseudo-resistant arterial hypertension as baseline reference, the hazard ratio for the composite endpoint was calculated.||4.8|1.1|0.04
71123129|NCT01173029|141751758|SUPERIORITY_OR_OTHER||C-statistic|0.66|||<|0.01|TWO_SIDED|95.0|0.56|0.76||At an optimal value of \>3, polygenic risk score yielded 90% sensitivity and 40% specificity for composite endpoint.|z test|Area under receiver operating characteristic curve.|The optimal cutoff value for polygenic risk score was set to \>3.|Receiver operating characteristic curve analysis for the polygenic score as predictor of composite endpoint (stroke + myocardial infarction)||0.76|0.56|<0.01
71123130|NCT01173029|141751758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.9||||0.04|TWO_SIDED|95.0|1.2|9.2||The p-value was adjusted for confounders: Framingham risk score, body mass index, ethnic group|Regression, Cox|The actuarial function of events per time since the first diagnosis of arterial hypertension was plotted for polygenic risk score\<=3 and \>3.||Cox proportional hazard model of the polygenic risk score\<=3 and \> 3 for the composite endpoint (stroke + myocardial infarction). By taking polygenic risk score\<=3, the hazard ratio for the composite endpoint was calculated for polygenic risk score\>3 .||9.2|1.2|0.04
71123131|NCT02469714|141751759|SUPERIORITY||Mean Difference (Final Values)|0.66||||0.04|TWO_SIDED||||||ANCOVA|||Between group comparison of total scheduled appointments from 1-13 months||||.04
71123132|NCT02469714|141751759|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.008|TWO_SIDED||||||ANCOVA|||Between group comparison of total achieved appointments from 1-13 months||||.008
71123133|NCT02469714|141751760|SUPERIORITY||Mean Difference (Final Values)|0.99||||0.135|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.135
71123134|NCT02469714|141751761|SUPERIORITY||Mean Difference (Final Values)|0.99||||0.077|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.077
71123135|NCT02469714|141751762|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.0005|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.0005
71123136|NCT02469714|141751763|SUPERIORITY||Mean Difference (Final Values)|1.05||||0.06|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.060
71123137|NCT02469714|141751764|SUPERIORITY||Mean Difference (Final Values)|1.03||||0.073|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.073
71123138|NCT02469714|141751765|SUPERIORITY||Mean Difference (Final Values)|0.93||||0.34|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.34
71123139|NCT02469714|141751766|SUPERIORITY||Mean Difference (Final Values)|0.95||||0.21|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.21
71123140|NCT02639338|141751774|SUPERIORITY|The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 83%.|||||<|0.001||||||The reported p-value was calculated. The statistical test was performed in SOF/VEL for 12 weeks at 0.05 significance level if and only if the statistical test performed in SOF/VEL/VOX for 8 weeks was significant at 0.05 significance level.|Binomial Test|||||||<0.001
71123141|NCT02639338|141751774|SUPERIORITY|The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 83%.|||||<|0.001||||||The reported p-value was calculated. The statistical test was performed in SOF/VEL for 12 weeks at 0.05 significance level if and only if the statistical test performed in SOF/VEL/VOX for 8 weeks was significant at 0.05 significance level.|2-sided exact 1-sample binomial test|||||||<0.001
71123142|NCT03131596|141751806|SUPERIORITY|||||||0.012||||||The p-value is not adjusted and a p-value of \< 0.05 is considered statistically significant.|Chi-squared|||200 patients were eligible and randomised in a 1:1 fashion. 9 patients did not complete the full protocol, resulting in 94 cases in the balloon group and 97 cases in the control group included in the final analysis. Intention-to-treat analysis was conducted.The null hypothesis is the percentage of the patients with reformed uterine adhesion in balloon group will less than the percentage of the patients with reformed uterine adhesion in control group. A Chi-squared analysis was used.||||0.012
71123143|NCT03131596|141751807|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71123144|NCT03131596|141751808|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71123145|NCT03131596|141751809|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||>0.05
71123146|NCT00734071|141751816|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.911||0.518|TWO_SIDED|95.0|-1.2|2.38||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.05, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|||P-values were tested at the 5% level of significance (ie, statistical significance if P\<0.05). To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.05, the testing procedure stopped for all subsequent endpoints.||2.38|-1.20|0.518
71123147|NCT00734071|141751817|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.542||0.685|TWO_SIDED|95.0|-1.29|0.85||Hierarchical testing stopped at the primary endpoint in the testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|||Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P\<0.05).||0.85|-1.29|0.685
71123148|NCT00734071|141751818|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.141||0.984|TWO_SIDED|95.0|-0.27|0.28||Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P\<0.05). No adjustments for multiplicity were made.|Mixed model for repeated measurements|||||0.28|-0.27|0.984
71123149|NCT00734071|141751819|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.866||0.703|TWO_SIDED|95.0|-1.38|2.04||Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P\<0.05). No adjustments for multiplicity were made.|Mixed model for repeated measurements|||||2.04|-1.38|0.703
71123150|NCT00734071|141751820|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.131||||0.602|TWO_SIDED|95.0|0.713|1.795|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.||||1.795|0.713|0.602
71123151|NCT00734071|141751821|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|1.558||0.995|TWO_SIDED|95.0|-3.09|3.07||Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P\<0.05). No adjustments for multiplicity were made.|Mixed model for repeated measurements|||||3.07|-3.09|0.995
71085417|NCT00676403|141676635|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|6.84||0.3739||95.0|-19.6|7.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.4|-19.6|0.3739
71085418|NCT00676403|141676635|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.2|STANDARD_ERROR_OF_MEAN|7.26||0.0517||95.0|-28.5|0.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-28.5|0.0517
71085419|NCT00676403|141676635|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.1|STANDARD_ERROR_OF_MEAN|6.92||0.0815||95.0|-25.8|1.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.5|-25.8|0.0815
71085420|NCT00676403|141676635|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.9|STANDARD_ERROR_OF_MEAN|7.0||0.0031||95.0|-34.7|-7.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-7.1|-34.7|0.0031
71085421|NCT00676403|141676636|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.6|STANDARD_ERROR_OF_MEAN|7.88||0.3368||95.0|-8.0|23.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.1|-8.0|0.3368
70872014|NCT00790023|141229441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|||<|0.0001|TWO_SIDED|95.0|0.63|1.37|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||1.37|0.63|<0.0001
70872015|NCT00790023|141229442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61||||0.0004|TWO_SIDED|95.0|0.28|0.95|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.95|0.28|0.0004
70944876|NCT00863798|141390425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.045|TWO_SIDED|95.0|0.01|0.98|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for social life and leisure activities component score."||0.98|0.01|0.045
71085422|NCT00676403|141676636|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.2|STANDARD_ERROR_OF_MEAN|7.75||0.4232||95.0|-21.5|9.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.1|-21.5|0.4232
71085423|NCT00676403|141676636|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|8.09||0.7082||95.0|-12.9|19.0|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||19.0|-12.9|0.7082
71085424|NCT00676403|141676636|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|7.7||0.9466||95.0|-15.7|14.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.7|-15.7|0.9466
71085425|NCT00676403|141676636|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|7.72||0.3746||95.0|-22.1|8.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.4|-22.1|0.3746
71123152|NCT00734071|141751822|SUPERIORITY_OR_OTHER||LS Mean Difference|1.02|STANDARD_ERROR_OF_MEAN|2.951||0.731|TWO_SIDED|95.0|-4.79|6.83||Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P\<0.05). No adjustments for multiplicity were made.|Mixed model for repeated measurements|||||6.83|-4.79|0.731
71123153|NCT00541346|141751865|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|26.3|||<|0.001|TWO_SIDED|95.0|19.6|33.1||Posterior-Predictive Probability of Mean Change (Pre-Post) Score at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||33.1|19.6|<0.001
70856566|NCT02047318|141199770|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ALT levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|42.3|STANDARD_DEVIATION|140.41||0.4934|TWO_SIDED|95.0|-105.0|189.7||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ALT levels was observed over time (with Week 252 chosen as the end point, as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||189.7|-105|0.4934
70856567|NCT02047318|141199771|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in AST levels between MRX baseline and Week 48 was statistically significant|Mean Difference (Net)|21.2|STANDARD_DEVIATION|58.98||0.1571|TWO_SIDED|95.0|-9.1|51.6||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in AST levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||51.6|-9.1|0.1571
70944877|NCT00863798|141390425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.277|TWO_SIDED|95.0|-0.22|0.76|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for social life and leisure activities component score."||0.76|-0.22|0.277
71123154|NCT00541346|141751866|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|23.1|||<|0.001|TWO_SIDED|95.0|16.9|29.3||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||29.3|16.9|<0.001
71123155|NCT00541346|141751867|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|10.9|||<|0.001|TWO_SIDED|95.0|5.4|16.8||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.||Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||16.8|5.4|<0.001
71123156|NCT00541346|141751868|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|7.2|||<|0.001|TWO_SIDED|95.0|3.3|11.1||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||11.1|3.3|<0.001
71123157|NCT00541346|141751869|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|4.1|||<|0.01||95.0|1.2|6.9||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||6.9|1.2|<0.01
71123158|NCT00541346|141751870|SUPERIORITY_OR_OTHER||Bayesian random intercept model.|3.5|||<|0.001|TWO_SIDED|95.0|1.8|5.2||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||5.2|1.8|<0.001
71123159|NCT00541346|141751871|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|-10.9|||<|0.001|TWO_SIDED|95.0|-16.8|-5.4||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Above Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds|Random intercept growth curves were fit to all outcome data. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear dose and time effects.||-5.4|-16.8|<0.001
70944878|NCT00863798|141390425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.056|TWO_SIDED|95.0|-0.01|0.91|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for family life/home responsibilities component score."||0.91|-0.01|0.056
71085426|NCT00676403|141676636|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|7.95||0.9336||95.0|-15.0|16.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.3|-15.0|0.9336
71085427|NCT00676403|141676636|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.8|STANDARD_ERROR_OF_MEAN|7.71||0.2029||95.0|-25.0|5.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.4|-25.0|0.2029
71085428|NCT00676403|141676636|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.1|STANDARD_ERROR_OF_MEAN|8.18||0.3833||95.0|-23.3|9.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.0|-23.3|0.3833
71085429|NCT00676403|141676636|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|7.72||0.8152||95.0|-17.0|13.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.4|-17.0|0.8152
71085430|NCT00676403|141676636|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.7|STANDARD_ERROR_OF_MEAN|7.81||0.1739||95.0|-26.1|4.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.7|-26.1|0.1739
71085431|NCT00676403|141676636|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.6|STANDARD_ERROR_OF_MEAN|7.94||0.3392||95.0|-8.0|23.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.3|-8.0|0.3392
71085432|NCT00676403|141676636|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|7.71||0.913||95.0|-16.0|14.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.4|-16.0|0.9130
71085433|NCT00676403|141676636|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|8.22||0.6||95.0|-20.5|11.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.9|-20.5|0.6000
71085434|NCT00676403|141676636|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.9|STANDARD_ERROR_OF_MEAN|7.75||0.4445||95.0|-9.3|21.2|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||21.2|-9.3|0.4445
71085435|NCT00676403|141676636|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|7.85||0.9656||95.0|-15.8|15.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||15.1|-15.8|0.9656
71123160|NCT00541346|141751872|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|1.94|||>|0.21|TWO_SIDED|95.0|-2.98|6.82||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||6.82|-2.98|>0.21
70944879|NCT00863798|141390425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.355|TWO_SIDED|95.0|-0.24|0.68|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for family life/home responsibilities component score."||0.68|-0.24|0.355
70856568|NCT02047318|141199772|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in AST levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|12.2|STANDARD_DEVIATION|101.84||0.7815|TWO_SIDED|95.0|-94.7|119.0||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in AST levels was observed over time (with Week 252 chosen as the end point as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||119|-94.7|0.7815
70944880|NCT00863798|141390426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54||||0.002|TWO_SIDED|95.0|-2.53|-0.56|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||-0.56|-2.53|0.002
70944881|NCT00863798|141390426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77||||0.129|TWO_SIDED|95.0|-1.75|0.22|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.22|-1.75|0.129
70944882|NCT00863798|141390427|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.3097|TWO_SIDED|95.0|0.52|1.23|||Regression, Linear|||Analysis was conducted using a logistic regression model with treatment and gender as factors and baseline sexual dysfunction status as a covariate.||1.23|0.52|0.3097
70944883|NCT00863798|141390427|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.272||||0.2794|TWO_SIDED|95.0|0.82|1.97|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment and gender as factors and baseline sexual dysfunction status as a covariate.||1.97|0.82|0.2794
70944884|NCT00863798|141390429|SUPERIORITY_OR_OTHER|||||||0.805|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 8.||||0.805
70944885|NCT00863798|141390429|SUPERIORITY_OR_OTHER|||||||0.805|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 9.||||0.805
70944886|NCT00863798|141390429|SUPERIORITY_OR_OTHER|||||||0.978|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 10.||||0.978
71085436|NCT00676403|141676636|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.6|STANDARD_ERROR_OF_MEAN|8.02||0.5679||95.0|-11.2|20.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||20.4|-11.2|0.5679
71085437|NCT00676403|141676636|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.5|STANDARD_ERROR_OF_MEAN|7.79||0.5619||95.0|-19.9|10.8|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.8|-19.9|0.5619
71085438|NCT00676403|141676636|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|8.31||0.993||95.0|-16.3|16.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.4|-16.3|0.9930
71085439|NCT00676403|141676636|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|7.79||0.6892||95.0|-12.2|18.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.5|-12.2|0.6892
71085440|NCT00676403|141676636|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.4|STANDARD_ERROR_OF_MEAN|7.89||0.4928||95.0|-21.0|10.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.1|-21.0|0.4928
71085441|NCT00676403|141676637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.6|STANDARD_ERROR_OF_MEAN|5.1||0.2719||95.0|-4.4|15.6|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||15.6|-4.4|0.2719
71085442|NCT00676403|141676637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|5.02||0.693||95.0|-7.9|11.8|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.8|-7.9|0.6930
71123161|NCT00541346|141751873|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|-3.4|||>|0.06|TWO_SIDED|95.0|-7.9|0.8||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Above Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear dose and time effects.||0.80|-7.9|>0.06
70944887|NCT00863798|141390429|SUPERIORITY_OR_OTHER|||||||0.805|TWO_SIDED||||||Regression, Logistic|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 8.||||0.805
70944888|NCT00863798|141390429|SUPERIORITY_OR_OTHER|||||||0.154|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 9.||||0.154
70944889|NCT00863798|141390429|SUPERIORITY_OR_OTHER|||||||0.805|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 10.||||0.805
70944890|NCT01917006|141390476|SUPERIORITY||Least square mean difference|0.11||||0.393||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from analysis of covariance (ANCOVA) Model with treatment as fixed effect and baseline geometric mean IELT as covariate.|ANCOVA|||||||0.393
71085443|NCT00676403|141676637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|5.24||0.7178||95.0|-12.2|8.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.4|-12.2|0.7178
70944891|NCT01917006|141390476|SUPERIORITY||Least Square Mean Difference|0.25||||0.263||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||||||0.263
71123162|NCT00541346|141751874|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|-5.26|||<|0.01|TWO_SIDED|95.0|-9.37|-1.18||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Above Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear dose and time effects.||-1.18|-9.37|<0.01
71123163|NCT00541346|141751875|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|7.6|||>|0.11|TWO_SIDED|95.0|-5.6|20.7||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||20.7|-5.6|>0.11
71123164|NCT04732949|141751876|OTHER||Hazard Ratio (HR)|1.06||||0.509|TWO_SIDED|95.0|0.89|1.27|||Cox proportional hazard model|||Hazard Ratio for time to hospital discharge - SNG001 vs Placebo||1.27|0.89|0.509
71123165|NCT04732949|141751877|OTHER||Hazard Ratio (HR)|1.02||||0.888|TWO_SIDED|95.0|0.81|1.28|||Cox proportional hazard model|||Hazard Ratio for time to OSCI recovery - SNG001 vs Placebo||1.28|0.81|0.888
71123166|NCT04732949|141751878|OTHER||Odds Ratio (OR)|0.71||||0.161|TWO_SIDED|95.0|0.44|1.15|||Regression, Logistic|||Odds Ratio for progression to severe disease or death - SNG001 vs Placebo||1.15|0.44|0.161
71123167|NCT04732949|141751879|OTHER||Odds Ratio (OR)|0.85||||0.61|TWO_SIDED|95.0|0.45|1.61|||Regression, Logistic|||Odds Ratio for intubation or death - SNG001 vs Placebo||1.61|0.45|0.610
71123168|NCT04732949|141751880|OTHER||Odds Ratio (OR)|0.79||||0.544|TWO_SIDED|95.0|0.38|1.67|||Regression, Logistic|||Odds Ratio for death - SNG001 vs Placebo||1.67|0.38|0.544
71123169|NCT04732949|141751881|OTHER||Odds Ratio (OR)|1.18||||0.323|TWO_SIDED|95.0|0.85|1.64|||Regression, Logistic|||Odds Ratio for hospital discharge (Day 7) - SNG001 vs Placebo||1.64|0.85|0.323
71123170|NCT04732949|141751881|OTHER||Odds Ratio (OR)|1.17||||0.406|TWO_SIDED|95.0|0.81|1.7|||Regression, Logistic|||Odds Ratio for hospital discharge (Day 14) - SNG001 vs Placebo||1.70|0.81|0.406
71123171|NCT04732949|141751881|OTHER||Odds Ratio (OR)|0.96||||0.828|TWO_SIDED|95.0|0.64|1.43|||Regression, Logistic|||Odds Ratio for hospital discharge (Day 21) - SNG001 vs Placebo||1.43|0.64|0.828
71123172|NCT04732949|141751881|OTHER||Odds Ratio (OR)|0.92||||0.706|TWO_SIDED|95.0|0.61|1.4|||Regression, Logistic|||Odds Ratio for hospital discharge (Day 28) - SNG001 vs Placebo||1.40|0.61|0.706
70944892|NCT01917006|141390476|SUPERIORITY||Least square mean difference|-0.39||||0.861||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||||||0.861
70944893|NCT01917006|141390476|SUPERIORITY||Least square mean difference|-0.14||||0.647||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||||||0.647
70944894|NCT01917006|141390476|SUPERIORITY||Least square mean difference|-0.13||||0.645||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||||||0.645
70944895|NCT01917006|141390476|SUPERIORITY||Least square mean difference|0.15||||0.343||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||||||0.343
71085444|NCT00676403|141676637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|4.96||0.8037||95.0|-11.0|8.5|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.5|-11.0|0.8037
71085445|NCT00676403|141676637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.7|STANDARD_ERROR_OF_MEAN|5.02||0.0832||95.0|-1.2|18.6|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.6|-1.2|0.0832
71085446|NCT00676403|141676637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|5.17||0.3554||95.0|-5.4|14.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.9|-5.4|0.3554
71085447|NCT00676403|141676637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|4.96||0.9538||95.0|-9.5|10.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.0|-9.5|0.9538
71085448|NCT00676403|141676637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|5.26||0.5593||95.0|-13.4|7.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.3|-13.4|0.5593
71085449|NCT00676403|141676637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|4.97||0.8663||95.0|-8.9|10.6|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.6|-8.9|0.8663
71085450|NCT00676403|141676637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|5.12||0.119||95.0|-2.1|18.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.1|-2.1|0.1190
71085451|NCT00676403|141676637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.4|STANDARD_ERROR_OF_MEAN|5.15||0.1544||95.0|-2.8|17.5|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||17.5|-2.8|0.1544
71085452|NCT00676403|141676637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|4.97||0.8439||95.0|-8.8|10.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.7|-8.8|0.8439
71123173|NCT04732949|141751882|OTHER||Odds Ratio (OR)|1.71||||0.101|TWO_SIDED|95.0|0.9|3.22|||Regression, Logistic|||Odds Ratio for OSCI recovery (Day 7) - SNG001 vs Placebo||3.22|0.90|0.101
71123174|NCT04732949|141751882|OTHER||Odds Ratio (OR)|0.99||||0.942|TWO_SIDED|95.0|0.67|1.45|||Regression, Logistic|||Odds Ratio for OSCI recovery (Day 14) - SNG001 vs Placebo||1.45|0.67|0.942
70944896|NCT01917006|141390477|SUPERIORITY||Least square mean difference|55.33||||0.184||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 versus (vs) Placebo at Week 2||||0.184
70944897|NCT01917006|141390477|SUPERIORITY||Least square mean difference|170.21||||0.002||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 2||||0.002
71085453|NCT00676403|141676637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|5.3||0.9925||95.0|-10.5|10.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.4|-10.5|0.9925
71085454|NCT00676403|141676637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|5.02||0.8784||95.0|-9.1|10.6|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.6|-9.1|0.8784
71085455|NCT00676403|141676637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|5.17||0.8948||95.0|-9.5|10.8|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.8|-9.5|0.8948
71085456|NCT00676403|141676637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.5|STANDARD_ERROR_OF_MEAN|5.26||0.2197||95.0|-3.9|16.8|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.8|-3.9|0.2197
71085457|NCT00676403|141676637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5|STANDARD_ERROR_OF_MEAN|5.07||0.6183||95.0|-7.4|12.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||12.5|-7.4|0.6183
71085458|NCT00676403|141676637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|5.42||0.4484||95.0|-14.8|6.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||6.5|-14.8|0.4484
71085459|NCT00676403|141676637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.4|STANDARD_ERROR_OF_MEAN|5.07||0.3857||95.0|-5.6|14.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.4|-5.6|0.3857
71085460|NCT00676403|141676637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|5.22||0.8824||95.0|-11.0|9.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.5|-11.0|0.8824
71123175|NCT04732949|141751882|OTHER||Odds Ratio (OR)|0.96||||0.824|TWO_SIDED|95.0|0.68|1.35|||Regression, Logistic|||Odds Ratio for OSCI recovery (Day 21) - SNG001 vs Placebo||1.35|0.68|0.824
71123176|NCT04732949|141751882|OTHER||Odds Ratio (OR)|0.92||||0.613|TWO_SIDED|95.0|0.66|1.28|||Regression, Logistic|||Odds Ratio for OSCI recovery (Day 28) - SNG001 vs Placebo||1.28|0.66|0.613
71123177|NCT04732949|141751884|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.41|TWO_SIDED|95.0|-0.1|0.3|||Mixed Models Analysis|||SNG001 vs Placebo||0.3|-0.1|0.410
71123178|NCT03323736|141751902|SUPERIORITY|The Procedural Success endpoint would be successfully met if the lower bound of the 95% Credible Interval (lower limit 0.80) exceeded the 68% success rate performance goal.|Credible Interval|0.86|||||TWO_SIDED|95.0|0.8|0.91||||||Procedural success rate was compared to the performance goal of 68% using a Bayesian Hierarchical model.||0.91|0.80|
71123179|NCT03323736|141751902|SUPERIORITY|The Procedural Success endpoint would be successfully met if the lower bound of the 95% Credible Interval (lower limit 0.82) exceeded the 68% success rate performance goal.|Credible Interval|0.89|||||TWO_SIDED|95.0|0.82|0.93||||||Procedural success rate was compared to the performance goal of 68% using a Bayesian Hierarchical model.||0.93|0.82|
71123180|NCT03323736|141751903|SUPERIORITY|Comparison of mean tube placement FPS-R score to a performance goal of 4.2.||||||0.0072||||||Mean FPS-R score hypothesized to be less than (superior to) a performance goal of 4.2, at a significance level of 0.025 (p\<0.025).|t-test, 1 sided|||||||0.0072
71123181|NCT03323736|141751904|SUPERIORITY||||||<|0.0001||||||Pre-specified threshold for superiority was \>80%, at alpha = 0.025.|mid-P method for single proportion|||Tube Patency endpoint would be successfully met if the percentage of subjects with patent tubes was greater than (superior to) 80% (by subject), at a significance level of 0.025 (p\<0.025).||||<0.0001
71123182|NCT03323736|141751905|SUPERIORITY||||||<|0.0001||||||Pre-specified threshold for superiority was \>88%, at alpha = 0.025.|mid-P method for single proportion|||Tube Retention endpoint would be successfully met if the percentage of subjects with retained tubes was greater than (superior to) 88% (by subject), at a significance level of 0.025 (p\<0.025).||||<0.0001
71085461|NCT00676403|141676638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.9|STANDARD_ERROR_OF_MEAN|7.87||0.1673||95.0|-4.6|26.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||26.4|-4.6|0.1673
70856569|NCT02047318|141199773|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in GGT levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|-3.9|STANDARD_DEVIATION|257.78||0.9513|TWO_SIDED|95.0|-136.4|128.7||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in GGT levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||128.7|-136.4|0.9513
70872016|NCT00790023|141229442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.0005|TWO_SIDED|95.0|0.27|0.94|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.94|0.27|0.0005
71085462|NCT00676403|141676638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|7.71||0.9839||95.0|-15.0|15.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||15.3|-15.0|0.9839
71123183|NCT03323736|141751906|SUPERIORITY||||||<|0.0001||||||Pre-specified threshold for superiority was \>85%, at alpha = 0.025.|mid-P method for single proportion|||The Anesthesia Effectiveness endpoint would be successfully met if the percentage of subjects with successful anesthesia was greater than (superior to) 85% (by subject), at a significance level of 0.025 (p\<0.025).||||<0.0001
71123184|NCT03710876|141751907|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.284|TWO_SIDED|95.0|0.43|1.59||1-sided|Log Rank|||||1.59|0.43|0.2840
70944898|NCT01917006|141390477|SUPERIORITY||Least square mean difference|12.73||||0.404||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 2||||0.404
71123185|NCT03710876|141751909|SUPERIORITY||Risk Difference (RD)|2.9||||1|TWO_SIDED|95.0|-17.3|24.3||2-sided|Fisher Exact||Risk difference is proportion achieving objective response in r+C+G group minus the proportion achieving objective response in C+ G group. The confidence interval was calculated by the exact conditional method of Chan and Zhang.|||24.3|-17.3|1.0000
71123186|NCT03710876|141751910|SUPERIORITY||Risk Difference (RD)|2.2||||1|TWO_SIDED|95.0|-25.2|29.2|||Fisher Exact||Risk difference is proportion achieving response in r+C+G group minus the proportion achieving response in C+ G group. The confidence interval was calculated by the exact conditional method of Chan and Zhang.|||29.2|-25.2|1.0000
71123187|NCT03710876|141751911|SUPERIORITY||Risk Difference (RD)|-7.6||||0.7665|TWO_SIDED|95.0|-34.9|20.3|||Fisher Exact||Risk difference is proportion achieving response in r+C+G group minus the proportion achieving response in C+ G group. The confidence interval was calculated by the exact conditional method of Chan and Zhang.|||20.3|-34.9|0.7665
71123188|NCT03710876|141751912|SUPERIORITY||Risk Difference (RD)|-4.4||||0.7537|TWO_SIDED|95.0|-31.7|23.0||2-sided.|Chi-squared|Variance calculated by Greenwood's method.|Risk difference is estimated probability of survival in r+C+G minus the estimated probability of survival in C+G group.|Percentage proportion calculated by Kaplan-Meier method.||23.0|-31.7|0.7537
71123189|NCT03710876|141751913|SUPERIORITY||Risk Difference (RD)|18.4||||0.1855|TWO_SIDED|95.0|-8.8|45.6||2-sided|Chi-squared|Variance calculated by Greenwood's method|Risk difference is estimated probability of survival in r+C+G minus the estimated probability of survival in C+G group.|Percentage proportion calculated by Kaplan-Meier method.||45.6|-8.8|0.1855
71123190|NCT03710876|141751914|SUPERIORITY||Risk Difference (RD)|12.2||||0.357|TWO_SIDED|95.0|-13.8|38.3||2-sided|Chi-squared|Variance calculated by Greenwood's method|Risk difference is estimated probability of survival in r+C+G minus the estimated probability of survival in C+G group.|Percentage proportion calculated by Kaplan-Meier method.||38.3|-13.8|0.3570
71123191|NCT03710876|141751915|SUPERIORITY||Risk Difference (RD)|13.5||||0.2856|TWO_SIDED|95.0|-11.3|38.3||2-sided|Chi-squared|Variance calculated by Greenwood's method.|Risk difference is estimated probability of survival in r+C+G minus the estimated probability of survival in C+G group.|Percentage proportion calculated by Kaplan-Meier method.||38.3|-11.3|0.2856
71123192|NCT03710876|141751916|SUPERIORITY||Risk Difference (RD)|6.1||||0.6173|TWO_SIDED|95.0|-17.8|30.0||2-sided|Chi-squared|Variance calculated by Greenwood's method.|Risk difference is estimated probability of survival in r+C+G minus the estimated probability of survival in C+G group.|Percentage proportion calculated by Kaplan-Meier method.||30.0|-17.8|0.6173
71123193|NCT03710876|141751917|SUPERIORITY||Risk Difference (RD)|6.1||||0.6173|TWO_SIDED|95.0|-17.8|30.0||2-sided|Chi-squared|Variance calculated by Greenwood's method.|Risk difference is estimated probability of survival in r+C+G minus the estimated probability of survival in C+G group.|Percentage proportion calculated by Kaplan-Meier method.||30.0|-17.8|0.6173
71123194|NCT02853435|141751919|OTHER||Ratio of geometric LS means|1.0417|||||TWO_SIDED|90.0|0.9809|1.1063|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters AUC(0-inf).|||1.1063|0.9809|
71123195|NCT02853435|141751919|OTHER||Ratio of geometric LS means|1.1108|||||TWO_SIDED|90.0|1.0459|1.1797|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters AUC(0-inf).|||1.1797|1.0459|
71123196|NCT02853435|141751920|OTHER||Ratio of geometric LS means|1.0408|||||TWO_SIDED|90.0|0.9792|1.1062|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters AUC(0-t).|||1.1062|0.9792|
71123197|NCT02853435|141751920|OTHER||Ratio of geometric LS means|1.1138|||||TWO_SIDED|90.0|1.0479|1.1838|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters AUC(0-t).|||1.1838|1.0479|
71123198|NCT02853435|141751922|OTHER||Ratio of geometric LS means|0.9586|||||TWO_SIDED|90.0|0.844|1.0888|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters Cmax.|||1.0888|0.8440|
71123199|NCT02853435|141751922|OTHER||Ratio of geometric LS means|1.1487|||||TWO_SIDED|90.0|1.0113|1.3047|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters Cmax.|||1.3047|1.0113|
71123200|NCT02853435|141751923|OTHER||Median Difference (Final Values)|-0.233||||0.309|TWO_SIDED|90.0|-0.267|0.0||The p-value is from Wilcoxon signed-rank test.|Wilcoxon signed-rank test.||The median, median difference and 90% CI of the median difference are from Hodge-Lehmann estimate.|||0.000|-0.267|0.309
71123201|NCT02853435|141751923|OTHER||Median Difference (Final Values)|-0.492|||<|0.001|TWO_SIDED|90.0|-0.5|-0.25||The p-value is from Wilcoxon signed-rank test.|Wilcoxon signed-rank test.||The median, median difference and 90% CI of the median difference are from Hodge-Lehmann estimate.|||-0.250|-0.500|<0.001
71123202|NCT04172467|141752082|OTHER|To estimate the relevance of guideline adherent treatment (GLAD) for the susceptibility to infection, full GLAD is taken as reference category.|Hazard Ratio (HR)|4.49|||<|0.001|TWO_SIDED|95.0|3.72|5.42||For effect estimation, hazard ratios are reported with 95% confidence interval. The significance level is set to two-sided ≤ 5% (p ≤ 0.05).|Regression, Cox|The Model developed by Anderson and Gill (1982) is an extension to the proportional hazard model (Cox model) for time to recurrent event analysis.||For the analysis of susceptibility to infection, the time to next infection was examined using the Andersen-Gill model. This model is an extension to the proportional hazard model (Cox model) for time to recurrent event analysis. The null hypothesis is that the GLAD-Score has no effect on susceptibility to infection.||5.42|3.72|<0.001
71123203|NCT04172467|141752082|OTHER|To estimate the relevance of guideline adherent treatment (GLAD) for the susceptibility to infection, full GLAD is taken as reference category.|Hazard Ratio (HR)|2.52|||<|0.001|TWO_SIDED|95.0|1.98|3.21||For effect estimation, hazard ratios are reported with 95% confidence interval. The significance level is set to two-sided ≤ 5% (p ≤ 0.05).|Regression, Cox|The Model developed by Anderson and Gill (1982) is an extension to the proportional hazard model (Cox model) for time to recurrent event analysis.||For the analysis of susceptibility to infection, the time to next infection was examined using the Andersen-Gill model. This model is an extension to the proportional hazard model (Cox model) for time to recurrent event analysis. The null hypothesis is that the GLAD-Score has no effect on susceptibility to infection.||3.21|1.98|<0.001
71123204|NCT04332614|141752083|SUPERIORITY||Odds Ratio (OR)|0.8791371||||0.0248|TWO_SIDED|95.0|0.7856042|0.9838058||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.9838058|0.7856042|0.0248
71085463|NCT00676403|141676638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.5|STANDARD_ERROR_OF_MEAN|8.06||0.2905||95.0|-7.3|24.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||24.4|-7.3|0.2905
71085464|NCT00676403|141676638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.6|STANDARD_ERROR_OF_MEAN|7.69||0.5513||95.0|-10.6|19.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||19.7|-10.6|0.5513
71085465|NCT00676403|141676638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|7.77||0.1589||95.0|-4.3|26.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||26.3|-4.3|0.1589
71085466|NCT00676403|141676638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.4|STANDARD_ERROR_OF_MEAN|7.95||0.0541||95.0|-0.3|31.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||31.0|-0.3|0.0541
71123205|NCT04332614|141752083|SUPERIORITY||Odds Ratio (OR)|0.5980109|||<|0.0001|TWO_SIDED|95.0|0.5159511|0.6931219||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.6931219|0.5159511|<0.0001
71123206|NCT04332614|141752083|SUPERIORITY||Odds Ratio (OR)|0.8380003||||0.0133|TWO_SIDED|95.0|0.7285712|0.9638653||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.9638653|0.7285712|0.0133
71123207|NCT04332614|141752084|SUPERIORITY||Odds Ratio (OR)|0.3700794|||<|0.0001|TWO_SIDED|95.0|0.2870513|0.4771231||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.4771231|0.2870513|<0.0001
70944899|NCT01917006|141390477|SUPERIORITY||Least square mean difference|24.23||||0.328||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 2||||0.328
71085467|NCT00676403|141676638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|7.66||0.5987||95.0|-11.0|19.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||19.1|-11.0|0.5987
71085468|NCT00676403|141676638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.3|STANDARD_ERROR_OF_MEAN|8.1||0.4372||95.0|-9.6|22.2|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||22.2|-9.6|0.4372
71085469|NCT00676403|141676638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|7.71||0.8336||95.0|-16.8|13.6|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.6|-16.8|0.8336
71085470|NCT00676403|141676638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.9|STANDARD_ERROR_OF_MEAN|7.9||0.0804||95.0|-1.7|29.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||29.4|-1.7|0.0804
71085471|NCT00676403|141676638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.3|STANDARD_ERROR_OF_MEAN|7.94||0.2985||95.0|-7.4|23.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.9|-7.4|0.2985
71085472|NCT00676403|141676638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|7.66||0.4991||95.0|-9.9|20.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||20.3|-9.9|0.4991
71123208|NCT04332614|141752084|SUPERIORITY||Odds Ratio (OR)|0.285144|||<|0.0001|TWO_SIDED|95.0|0.1881589|0.4321194||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.4321194|0.1881589|<0.0001
71123209|NCT04332614|141752084|SUPERIORITY||Odds Ratio (OR)|0.5565905||||0.0003|TWO_SIDED|95.0|0.4059477|0.7631354||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.7631354|0.4059477|0.0003
71123210|NCT04332614|141752085|SUPERIORITY||Odds Ratio (OR)|0.72429741||||0.103|TWO_SIDED|95.0|0.49167734|1.0669736||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||1.0669736|0.49167734|0.103
71123211|NCT04332614|141752085|SUPERIORITY||Odds Ratio (OR)|0.63578603||||0.12|TWO_SIDED|95.0|0.35943749|1.1246013||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||1.1246013|0.35943749|0.120
71123212|NCT04332614|141752085|SUPERIORITY||Odds Ratio (OR)|1.06482385||||0.789|TWO_SIDED|95.0|0.67282661|1.6852036||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||1.6852036|0.67282661|0.789
71123213|NCT04332614|141752086|SUPERIORITY||Odds Ratio (OR)|0.8837908||||0.0286|TWO_SIDED|95.0|0.7912382|0.9871694||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.9871694|0.7912382|0.0286
71123214|NCT04332614|141752086|SUPERIORITY||Odds Ratio (OR)|0.6000149|||<|0.0001|TWO_SIDED|95.0|0.5193168|0.6932528||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.6932528|0.5193168|<0.0001
71123215|NCT04332614|141752086|SUPERIORITY||Odds Ratio (OR)|0.8225743||||0.0055|TWO_SIDED|95.0|0.7167043|0.9440832|||Regression, Logistic|||||0.9440832|0.7167043|0.0055
71123216|NCT04332614|141752087|SUPERIORITY||Odds Ratio (OR)|0.3948795|||<|0.0001|TWO_SIDED|95.0|0.310437|0.5022914||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.5022914|0.3104370|<0.0001
71123217|NCT04332614|141752087|SUPERIORITY||Odds Ratio (OR)|0.2790595|||<|0.0001|TWO_SIDED|95.0|0.1875017|0.4153254||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.4153254|0.1875017|<0.0001
71123218|NCT04332614|141752087|SUPERIORITY||Odds Ratio (OR)|0.6097538||||0.0011|TWO_SIDED|95.0|0.4528751|0.8209762||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.8209762|0.4528751|0.0011
71123219|NCT04332614|141752088|SUPERIORITY||Odds Ratio (OR)|1.0049587||||0.976|TWO_SIDED|95.0|0.72693253|1.3893201||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||1.3893201|0.72693253|0.976
71123220|NCT04332614|141752088|SUPERIORITY||Odds Ratio (OR)|0.7576895||||0.246|TWO_SIDED|95.0|0.4741259|1.2108458||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||1.2108458|0.47412590|0.246
71123221|NCT04332614|141752088|SUPERIORITY||Odds Ratio (OR)|1.1728665||||0.428|TWO_SIDED|95.0|0.79090107|1.7393021||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||1.7393021|0.79090107|0.428
71123222|NCT04332614|141752089|SUPERIORITY||Odds Ratio (OR)|0.9980487||||1|TWO_SIDED|95.0|0.8680298|1.147543||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.147543|0.8680298|1
71123223|NCT04332614|141752089|SUPERIORITY||Odds Ratio (OR)|0.8953032||||0.276|TWO_SIDED|95.0|0.7771682|1.031395||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.031395|0.7771682|0.276
71123224|NCT04332614|141752089|SUPERIORITY||Odds Ratio (OR)|0.8970536||||0.289|TWO_SIDED|95.0|0.7785981|1.033531||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.033531|0.7785981|0.289
71123225|NCT04332614|141752090|SUPERIORITY||Odds Ratio (OR)|0.9313889||||0.94591|TWO_SIDED|95.0|0.6003591|1.444944||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.444944|0.6003591|0.94591
71123226|NCT04332614|141752090|SUPERIORITY||Odds Ratio (OR)|1.8998642||||0.0041|TWO_SIDED|95.0|1.2809137|2.817898||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||2.817898|1.2809137|0.0041
71123227|NCT04332614|141752090|SUPERIORITY||Odds Ratio (OR)|2.0398184||||0.0015|TWO_SIDED|95.0|1.3648075|3.048678||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||3.048678|1.3648075|0.0015
71123228|NCT04332614|141752091|SUPERIORITY||Odds Ratio (OR)|1.180837||||0.829|TWO_SIDED|95.0|0.6750639|2.065546||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||2.065546|0.6750639|0.829
71123229|NCT04332614|141752091|SUPERIORITY||Odds Ratio (OR)|1.432003||||0.404|TWO_SIDED|95.0|0.8279689|2.476702||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||2.476702|0.8279689|0.404
71123230|NCT04332614|141752091|SUPERIORITY||Odds Ratio (OR)|1.212702||||0.753|TWO_SIDED|95.0|0.7161724|2.05348||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||2.053480|0.7161724|0.753
71123231|NCT04332614|141752092|SUPERIORITY||Odds Ratio (OR)|0.9747188||||0.9284|TWO_SIDED|95.0|0.8501783|1.1175028||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.1175028|0.8501783|0.9284
70872017|NCT01652703|141229475|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.61|STANDARD_ERROR_OF_MEAN|2.99|<|0.001|TWO_SIDED|95.0|-74.51|-62.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-62.71|-74.51|<0.001
71123232|NCT04332614|141752092|SUPERIORITY||Odds Ratio (OR)|0.8518974||||0.0612|TWO_SIDED|95.0|0.741461|0.9787827||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||0.9787827|0.7414610|0.0612
71123233|NCT04332614|141752092|SUPERIORITY||Odds Ratio (OR)|0.873993||||0.1407|TWO_SIDED|95.0|0.7602296|1.0047804||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.0047804|0.7602296|0.1407
71123234|NCT04332614|141752093|SUPERIORITY||Odds Ratio (OR)|0.9089673||||0.8848|TWO_SIDED|95.0|0.6109603|1.352333||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.352333|0.6109603|0.8848
71123235|NCT04332614|141752093|SUPERIORITY||Odds Ratio (OR)|1.6914929||||0.0127|TWO_SIDED|95.0|1.1762411|2.43245||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||2.432450|1.1762411|0.0127
71123236|NCT04332614|141752093|SUPERIORITY||Odds Ratio (OR)|1.8608951||||0.0033|TWO_SIDED|95.0|1.2800275|2.705356||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||2.705356|1.2800275|0.0033
71123237|NCT04332614|141752094|SUPERIORITY||Odds Ratio (OR)|0.8619131||||0.759|TWO_SIDED|95.0|0.5709078|1.301251||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.301251|0.5709078|0.759
71123238|NCT04332614|141752094|SUPERIORITY||Odds Ratio (OR)|1.0950508||||0.897|TWO_SIDED|95.0|0.7331329|1.635633||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.635633|0.7331329|0.897
71123239|NCT04332614|141752094|SUPERIORITY||Odds Ratio (OR)|1.2704886||||0.498|TWO_SIDED|95.0|0.8377249|1.926816||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.926816|0.8377249|0.498
71123240|NCT04191499|141752104|SUPERIORITY||Hazard Ratio (HR)|0.43|||<|0.0001|TWO_SIDED|95.0|0.32|0.59|||Log Rank|||Hazard ratios were estimated by Cox regression. Hazard ratios and log-rank p-values are using stratified methods by stratifying Visceral Disease, Endocrine Resistance, and Region.||0.59|0.32|<0.0001
71123241|NCT02937766|141752129|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.25||0.093|TWO_SIDED|95.0|-0.1|0.9|||t-test, 2 sided|The t-test tested the hypothesis of no treatment difference between treatment groups.||||0.9|-0.1|0.093
71123242|NCT02937766|141752130|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.234|TWO_SIDED|95.0|-0.2|0.7||The t-test tested the hypothesis of no treatment difference between treatment groups.|t-test, 2 sided|||||0.7|-0.2|0.234
70944900|NCT01917006|141390477|SUPERIORITY||Least square mean difference|18.48||||0.362||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 2||||0.362
70944901|NCT01917006|141390477|SUPERIORITY||Least square mean difference|45.42||||0.203||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 2||||0.203
70944902|NCT01917006|141390477|SUPERIORITY||Least square mean difference|33.05||||0.322||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 4||||0.322
71085473|NCT00676403|141676638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.1|STANDARD_ERROR_OF_MEAN|8.15||0.2675||95.0|-7.0|25.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||25.1|-7.0|0.2675
71085474|NCT00676403|141676638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|7.77||0.1593||95.0|-4.3|26.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||26.3|-4.3|0.1593
71085475|NCT00676403|141676638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.9|STANDARD_ERROR_OF_MEAN|7.96||0.0179||95.0|3.3|34.6|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||34.6|3.3|0.0179
71085476|NCT00676403|141676638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|17.8|STANDARD_ERROR_OF_MEAN|8.06||0.0281||95.0|1.9|33.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||33.7|1.9|0.0281
71085477|NCT00676403|141676638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.3|STANDARD_ERROR_OF_MEAN|7.77||0.1883||95.0|-5.0|25.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||25.5|-5.0|0.1883
71085478|NCT00676403|141676638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.0|STANDARD_ERROR_OF_MEAN|8.28||0.23||95.0|-6.3|26.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||26.3|-6.3|0.2300
71085479|NCT00676403|141676638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|7.82||0.7575||95.0|-13.0|17.8|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||17.8|-13.0|0.7575
71085480|NCT00676403|141676638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.3|STANDARD_ERROR_OF_MEAN|8.02||0.0757||95.0|-1.5|30.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||30.1|-1.5|0.0757
71123243|NCT04271475|141752146|SUPERIORITY||Least square mean|-16.1|STANDARD_ERROR_OF_MEAN|8.2||0.974|TWO_SIDED|95.0|-32.34|0.16|||MMRM||Least square mean and SE of the mean was estimated by mixed model repeated measurements method.|||0.16|-32.34|0.974
71123244|NCT00733135|141752153|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||GEE|||||||<0.05
71123245|NCT00159913|141752159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.71|STANDARD_ERROR_OF_MEAN|3.98||0.056||95.0|-0.19|15.6||No adjustments for multiple comparisons have been made.|ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates.||||15.60|-0.19|0.056
71123246|NCT00159913|141752159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.81|STANDARD_ERROR_OF_MEAN|5.0||||95.0|-6.11|13.73|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates.||||13.73|-6.11|
70944903|NCT01917006|141390477|SUPERIORITY||Least square mean difference|148.86||||0.015||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 4||||0.015
71123247|NCT00159913|141752159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|11.33|STANDARD_ERROR_OF_MEAN|4.84||||95.0|1.72|20.94|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates.||||20.94|1.72|
70944904|NCT01917006|141390477|SUPERIORITY||Least square mean difference|-6.2||||0.541||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 4||||0.541
70856570|NCT02047318|141199774|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in GGT levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|-56.7|STANDARD_DEVIATION|356.88||0.7133|TWO_SIDED|95.0|-431.2|317.9||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in GGT levels was observed over time (with Week 252 chosen as the end point as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||317.9|-431.2|0.7133
70944905|NCT01917006|141390477|SUPERIORITY||Least square mean difference|6.47||||0.459||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 4||||0.459
71123248|NCT00159913|141752159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.98|STANDARD_ERROR_OF_MEAN|4.85||||95.0|-1.64|17.6|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates.||||17.60|-1.64|
71123249|NCT00159913|141752160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|2.2||0.172||95.0|-7.5|1.3|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met with main analysis: alternative=excluding outliers||||1.3|-7.5|0.172
71123250|NCT00159913|141752160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|3.1||||95.0|-4.5|7.6|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met with main analysis: alternative=excluding outliers||||7.6|-4.5|
71123251|NCT00159913|141752160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|2.7||||95.0|-8.9|1.9|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met with main analysis: alternative=excluding outliers||||1.9|-8.9|
71123252|NCT00159913|141752160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|2.6||||95.0|-12.4|-2.1|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met with main analysis: alternative=excluding outliers||||-2.1|-12.4|
71123253|NCT00159913|141752161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|2.0||0.041||95.0|-8.0|-0.2|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met w/ main analysis: alternative=natural log transformed||||-0.2|-8.0|0.041
71123254|NCT00159913|141752161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.7||||95.0|-5.9|4.7|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met w/ main analysis: alternative=natural log transformed||||4.7|-5.9|
71123255|NCT00159913|141752161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.5|STANDARD_ERROR_OF_MEAN|2.4||||95.0|-9.3|0.3|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met w/ main analysis: alternative=natural log transformed||||0.3|-9.3|
71123256|NCT00159913|141752161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.2|STANDARD_ERROR_OF_MEAN|2.3||||95.0|-11.7|-2.7|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met w/ main analysis: alternative=natural log transformed||||-2.7|-11.7|
71123257|NCT00159913|141752162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|2.36||0.795||95.0|-4.07|5.3|||ANCOVA|The model included the covariates etiology and weight group||||5.30|-4.07|0.795
71123258|NCT00159913|141752162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.62|STANDARD_ERROR_OF_MEAN|2.99||||95.0|-3.31|8.54|||ANCOVA|The model included the covariates etiology and weight group||||8.54|-3.31|
71123259|NCT00159913|141752162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|2.92||||95.0|-7.09|4.5|||ANCOVA|The model included the covariates etiology and weight group||||4.50|-7.09|
71123260|NCT00159913|141752162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|2.9||||95.0|-5.24|6.28|||ANCOVA|The model included the covariates etiology and weight group||||6.28|-5.24|
71123261|NCT00159913|141752163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.24|STANDARD_ERROR_OF_MEAN|6.2||0.139||95.0|-3.05|21.54|||ANCOVA|The model included the covariates etiology and weight group||||21.54|-3.05|0.139
71123262|NCT00159913|141752163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.34|STANDARD_ERROR_OF_MEAN|7.84||||95.0|-5.21|25.9|||ANCOVA|The model included the covariates etiology and weight group||||25.90|-5.21|
71123263|NCT00159913|141752163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.43|STANDARD_ERROR_OF_MEAN|7.67||||95.0|-3.78|26.64|||ANCOVA|The model included the covariates etiology and weight group||||26.64|-3.78|
71123264|NCT00159913|141752163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.96|STANDARD_ERROR_OF_MEAN|7.62||||95.0|-9.16|21.08|||ANCOVA|The model included the covariates etiology and weight group||||21.08|-9.16|
71123265|NCT00159913|141752164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|2.1||0.172||95.0|-7.1|1.3|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.3|-7.1|0.172
71123266|NCT00159913|141752164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|2.9||||95.0|-5.5|5.9|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||5.9|-5.5|
71123267|NCT00159913|141752164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|2.6||||95.0|-8.5|1.7|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.7|-8.5|
71123268|NCT00159913|141752164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|2.4||||95.0|-10.3|-0.7|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||-0.7|-10.3|
71123269|NCT00159913|141752165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.74|STANDARD_ERROR_OF_MEAN|0.3||0.015||95.0|0.14|1.34|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.34|0.14|0.015
70856571|NCT02047318|141199775|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in total bilirubin levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|0.16|STANDARD_DEVIATION|2.348||0.7839|TWO_SIDED|95.0|-1.05|1.37||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in total bilirubin levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||1.37|-1.05|0.7839
70856572|NCT02047318|141199775|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in direct bilirubin levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|-0.15|STANDARD_DEVIATION|0.982||0.5298|TWO_SIDED|95.0|-0.66|0.35||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in direct bilirubin levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||0.35|-0.66|0.5298
70856573|NCT02047318|141199776|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in total bilirubin levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|-0.53|STANDARD_DEVIATION|5.505||0.8218|TWO_SIDED|95.0|-6.31|5.24||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in total bilirubin levels was observed over time (with Week 252 chosen as the end point as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||5.24|-6.31|0.8218
70856574|NCT02047318|141199776|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in direct bilirubin levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|-0.52|STANDARD_DEVIATION|2.001||0.5549|TWO_SIDED|95.0|-2.62|1.58||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in direct bilirubin levels was observed over time (with Week 252 chosen as the end point as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||1.58|-2.62|0.5549
71123270|NCT00159913|141752165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|0.41||||95.0|-0.1|1.52|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.52|-0.10|
71123271|NCT00159913|141752165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.37||||95.0|-0.12|1.35|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.35|-0.12|
71123272|NCT00159913|141752165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.89|STANDARD_ERROR_OF_MEAN|0.35||||95.0|0.21|1.58|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.58|0.21|
71123273|NCT00159913|141752166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.64||0.44||95.0|-1.77|0.77|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||0.77|-1.77|0.440
71123274|NCT00159913|141752166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.88||||95.0|-1.91|1.57|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.57|-1.91|
71123275|NCT00159913|141752166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.78||||95.0|-1.73|1.36|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.36|-1.73|
71123276|NCT00159913|141752166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|0.75||||95.0|-2.61|0.33|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||0.33|-2.61|
71123277|NCT00159913|141752167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|1.93||0.75||95.0|-4.45|3.21|||ANCOVA|The covariates included in the model were baseline scale, etiology, weight and capability of performing the exercise test.||||3.21|-4.45|0.750
71123278|NCT00159913|141752167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.87|STANDARD_ERROR_OF_MEAN|2.57||||95.0|-4.21|5.95|||ANCOVA|||||5.95|-4.21|
71123279|NCT00159913|141752167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|2.49||||95.0|-4.68|5.15|||ANCOVA|||||5.15|-4.68|
71123280|NCT00159913|141752167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.96|STANDARD_ERROR_OF_MEAN|2.23||||95.0|-7.37|1.45|||ANCOVA|||||1.45|-7.37|
71123281|NCT00159913|141752168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|1.51||0.784||95.0|-3.41|2.58|||ANCOVA|The covariates included in the model were baseline scale, etiology, weight and capability of performing the exercise test.||||2.58|-3.41|0.784
71123282|NCT00159913|141752168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|1.97||||95.0|-3.49|4.3|||ANCOVA|||||4.30|-3.49|
71123283|NCT00159913|141752168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.11|STANDARD_ERROR_OF_MEAN|1.96||||95.0|-5.99|1.77|||ANCOVA|||||1.77|-5.99|
71123284|NCT00159913|141752168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|1.77||||95.0|-3.06|3.97|||ANCOVA|||||3.97|-3.06|
71123285|NCT00159913|141752169|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.83||||0.184||95.0|0.75|4.45|||Regression, Logistic|Proportional odds method. Model covariates were baseline WHO functional class, etiology, weight group and capability of performing the exercise test.||||4.45|0.75|0.184
71123286|NCT00159913|141752169|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.6||||0.409||95.0|0.18|2.01|||Regression, Logistic|Proportional odds method. Model covariates were baseline WHO functional class, etiology, weight group and capability of performing the exercise test.||||2.01|0.18|0.409
71123287|NCT00159913|141752169|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.25||||0.146||95.0|0.75|6.69|||Regression, Logistic|Proportional odds method. Model covariates were baseline WHO functional class, etiology, weight group and capability of performing the exercise test.||||6.69|0.75|0.146
70856575|NCT02296138|141199777|SUPERIORITY|This hypothesis testing strategy ensures that the overall type I error is protected at 2-sided 0.01 level.|Ratio of rates vs. Tiotropium 5 μg|0.93||||0.0498|TWO_SIDED|99.0|0.85|1.02|||Negative binomial model||Ratio of events Tiotropium (5 μg) + Olodaterol (5 μg) versus Tiotropium (5 μg) is provided.|Annualised rate of moderate to severe COPD exacerbation was analysed using a negative binomial model including the fixed, categorical effect of treatment as well as the logarithm of the treatment exposure as an offset.||1.02|0.85|0.0498
70856576|NCT02296138|141199777|SUPERIORITY||Ratio of rates|0.89||||0.001|TWO_SIDED|95.0|0.84|0.96|||Negative binomial model||Ratio of rates Tiotropium (5 μg) versus Tiotropium (5 μg) + Olodaterol (5 μg) is provided.|Model was based on SPARK/FLAME- Covariates: Smoking status, baseline inhaled corticosteroid, Global Initiative on Chronic Obstructive Lung Disease stage, region, COPD Assessment Test score (replacing baseline symptom score), exacerbations treated with antibiotics/steroids history in previous year (replacing 1-year history of exacerbations)||0.96|0.84|0.0010
70856577|NCT02296138|141199777|SUPERIORITY||Ratio of rates|0.91||||0.008|TWO_SIDED|95.0|0.85|0.98|||Negative binomial model||Ratio of rates Tiotropium (5 μg) versus Tiotropium (5 μg) + Olodaterol (5 μg) is provided.|Model was based on HERMES- Covariates: age, sex, smoking status, baseline Long-acting Beta-agonist/inhaled corticosteroid, region and percent predicted post-bronchodilator Forced Expiratory Volume in One Second||0.98|0.85|0.0080
70856578|NCT02296138|141199777|SUPERIORITY||Ratio of rates|0.89||||0.0011|TWO_SIDED|95.0|0.84|0.96|||Negative binomial model||Ratio of rates Tiotropium (5 μg) versus Tiotropium (5 μg) + Olodaterol (5 μg) is provided.|Model was based on TRINITY/TRILOGY- Covariates: Treatment, region, severity of airflow limitation, and smoking status as effects, and exacerbations treated with antibiotics/steroids in previous year.||0.96|0.84|0.0011
70856579|NCT02296138|141199778|SUPERIORITY|This hypothesis testing strategy ensures that the overall type I error is protected at 2-sided 0.01 level.|Hazard Ratio (HR)|0.95||||0.1188|TWO_SIDED|99.0|0.87|1.03|||Log Rank||Tiotropium (5 μg) + Olodaterol (5 μg) versus Tiotropium (5 μg)|A Cox's proportional hazard model was used to estimate the hazard ratio and the corresponding Confidence Interval. A log-rank test was used to obtain the p-value||1.03|0.87|0.1188
70944906|NCT01917006|141390477|SUPERIORITY||Least square mean difference|1.32||||0.491||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 4||||0.491
71123288|NCT00159913|141752169|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.52||||0.006||95.0|1.56|13.1|||Regression, Logistic|Proportional odds method. Model covariates were baseline WHO functional class, etiology, weight group and capability of performing the exercise test.||||13.10|1.56|0.006
70944907|NCT01917006|141390477|SUPERIORITY||Least square mean difference|36.8||||0.281||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 4||||0.281
71123289|NCT00159913|141752170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.89|STANDARD_ERROR_OF_MEAN|4.35||0.179||95.0|-2.74|14.53|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates||||14.53|-2.74|0.179
71123290|NCT00159913|141752170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.14|STANDARD_ERROR_OF_MEAN|5.35||||95.0|-9.49|11.77|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates||||11.77|-9.49|
71123291|NCT00159913|141752170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.3|STANDARD_ERROR_OF_MEAN|5.36||||95.0|0.66|21.96|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates||||21.96|0.66|
71123292|NCT00159913|141752170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.24|STANDARD_ERROR_OF_MEAN|5.16||||95.0|-5.02|15.5|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates||||15.50|-5.02|
71123293|NCT00824005|141752171|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|2.9||0.169|TWO_SIDED|95.0|-0.42|2.34||No adjustment for multiple comparisons|t-test, 2 sided|||Compare the change in the cell group to the change in the placebo group.||2.34|-0.42|0.169
71123294|NCT00824005|141752172|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|23.9||0.856|TWO_SIDED|95.0|-10.05|12.07|||t-test, 2 sided|||Change in the difference of end systolic volume over time.||12.07|-10.05|0.856
71123295|NCT00824005|141752173|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|22.3||0.835|TWO_SIDED|95.0|-12.5|10.1||Is the change in percent reversible defect the same between the two groups|t-test, 2 sided|||Change in percent of the defect that is reversible||10.1|-12.5|0.835
71123296|NCT00824005|141752176|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.471|TWO_SIDED|95.0|-0.3|0.14|||t-test, 2 sided|||Difference in the change between the two groups||0.14|-0.30|0.471
71123297|NCT00824005|141752177|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25|STANDARD_DEVIATION|0.784||0.227|TWO_SIDED|95.0|-0.66|0.16|||t-test, 2 sided|||Change in average improvement in Canadian Class Score over time between the two groups.||0.16|-0.66|0.227
71123298|NCT00824005|141752178|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.176|STANDARD_ERROR_OF_MEAN|0.845||0.361|TWO_SIDED|95.0|-0.56|0.21|||t-test, 2 sided|||Difference in the change in NYHA score between the two groups||0.21|-0.56|0.361
71123299|NCT00824005|141752179|SUPERIORITY_OR_OTHER||Difference in the proportion of particip|0.04|STANDARD_DEVIATION|0.045||0.28|TWO_SIDED|95.0|-0.01|0.09|||Chi-squared|||Difference in the change in anti-anginal meds across groups||0.09|-0.01|0.28
71123300|NCT00824005|141752180|SUPERIORITY_OR_OTHER||Mean Difference (Net)|104.0|STANDARD_DEVIATION|409.0||0.302|TWO_SIDED|95.0|-95.0|303.0|||t-test, 2 sided|||Change in six minute walk distance||303|-95|0.302
71123301|NCT00824005|141752181|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.7|STANDARD_DEVIATION|176.0||0.55|TWO_SIDED|95.0|-150.0|80.0|||t-test, 2 sided|||Difference in the change in BNP(reg) between cell and placebo group||80|-150|0.55
71123302|NCT00824005|141752182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.5|STANDARD_DEVIATION|31.2||0.198|TWO_SIDED|95.0|-5.03|23.93|||t-test, 2 sided|||Change in the difference of end diastolic volume between the two groups over time.||23.93|-5.03|0.198
71123303|NCT00824005|141752183|SUPERIORITY_OR_OTHER||Difference in the incidence rates|-0.047|STANDARD_ERROR_OF_MEAN|0.044||0.47|TWO_SIDED|95.0|-0.133|0.039|||t-test, 2 sided|||The difference in the incidence of major adverse cardiac events between the two groups over time. (Incidence rate)||0.039|-0.133|0.47
71123304|NCT00824005|141752184|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|8.4||0.7|TWO_SIDED|95.0|-4.78|3.36|||t-test, 2 sided|||Difference in the change between the two groups||3.36|-4.78|0.7
71123305|NCT01874275|141752187|SUPERIORITY_OR_OTHER|||||||0.2413|TWO_SIDED||||||Mixed Models Analysis|||||||0.2413
71123306|NCT00168103|141752197|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.525||||0.0025|TWO_SIDED|95.0|-2.217|-0.033||1-sided P-value. The a priori threshold was 0.024 (overall Type 1 error 0.025 adjusted for alpha spending for an interim analysis).|Wilcoxon (Mann-Whitney)|1-sided|The median difference was estimated by the Hodges-Lehmann estimate.|||-0.033|-2.217|0.0025
71123307|NCT00168103|141752198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1088||||0.0014|TWO_SIDED|80.0|0.0392|0.3023||1-sided P-value. The a priori threshold for significance was 0.1 (trend).|Fisher Exact|1-sided|The Odds Ratio was calculated as C1-INH 20 U/kg bw (numerator) versus Placebo (denominator).|Worsened intensity was evaluated between 2 and 4 hours after start of study treatment relative to baseline for at least 1 of the HAE symptoms present at baseline.||0.3023|0.0392|0.0014
71123308|NCT00168103|141752199|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.292||||0.0237|TWO_SIDED|80.0|-5.15|-1.05||1-sided, exploratory test.|Wilcoxon (Mann-Whitney)|1-sided|The median difference was estimated by the Hodge-Lehmann estimate.|This was an exploratory analysis.||-1.050|-5.150|0.0237
71123309|NCT00168103|141752200|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1714|||||TWO_SIDED|95.0|0.0642|0.4575|||||The Odds Ratio was calculated as C1-INH 20 U/kg bw (numerator) versus Placebo (denominator).|This was an exploratory analysis.||0.4575|0.0642|
71123310|NCT00168103|141752201|SUPERIORITY_OR_OTHER|||||||0.0329|TWO_SIDED|80.0||||1-sided P-value. The a priori threshold for significance was 0.1 (trend).|Wilcoxon (Mann-Whitney)|1-sided||||||0.0329
71123311|NCT00989235|141752204|SUPERIORITY_OR_OTHER||Adjusted difference|0.18|||||TWO_SIDED|95.0|-0.11|0.46|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 29||0.46|-0.11|
71123312|NCT00989235|141752204|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.09|||||TWO_SIDED|95.0|-0.34|0.17|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 57||0.17|-0.34|
71085481|NCT00676403|141676639|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.4|STANDARD_ERROR_OF_MEAN|5.89||0.2817||95.0|-18.0|5.2|||Mixed Models Analysis|||Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.2|-18.0|0.2817
71085482|NCT00676403|141676639|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|5.76||0.6796||95.0|-13.7|9.0|||Mixed Models Analysis|||Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.0|-13.7|0.6796
71085483|NCT00676403|141676639|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|6.01||0.2505||95.0|-18.8|4.9|||Mixed Models Analysis|||Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.9|-18.8|0.2505
71085484|NCT00676403|141676639|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|5.73||0.5102||95.0|-15.1|7.5|||Mixed Models Analysis|||Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.5|-15.1|0.5102
71085485|NCT00676403|141676639|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|5.78||0.5706||95.0|-14.7|8.1|||Mixed Models Analysis|||Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.1|-14.7|0.5706
71085486|NCT00676403|141676639|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|5.95||0.4708||95.0|-16.0|7.4|||Mixed Models Analysis|||Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.4|-16.0|0.4708
71085487|NCT00676403|141676639|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|5.72||0.6202||95.0|-8.4|14.1|||Mixed Models Analysis|||Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.1|-8.4|0.6202
71085488|NCT00676403|141676639|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|6.04||0.4177||95.0|-16.8|7.0|||Mixed Models Analysis|||Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.0|-16.8|0.4177
71085489|NCT00676403|141676639|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|5.75||0.6509||95.0|-8.7|13.9|||Mixed Models Analysis|||Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.9|-8.7|0.6509
71085490|NCT00676403|141676639|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|5.86||0.8273||95.0|-10.3|12.8|||Mixed Models Analysis|||Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||12.8|-10.3|0.8273
71085491|NCT00676403|141676639|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.4|STANDARD_ERROR_OF_MEAN|5.94||0.2842||95.0|-18.1|5.3|||Mixed Models Analysis|||Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.3|-18.1|0.2842
71085492|NCT00676403|141676639|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|5.72||0.7041||95.0|-9.1|13.5|||Mixed Models Analysis|||Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.5|-9.1|0.7041
71123313|NCT00989235|141752204|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.08|||||TWO_SIDED|95.0|-0.37|0.2|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 85||0.20|-0.37|
71123314|NCT00989235|141752204|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.23|||||TWO_SIDED|95.0|-0.5|0.04|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 113||0.04|-0.50|
71123315|NCT00989235|141752204|SUPERIORITY_OR_OTHER||Adjusted Difference|0.03|||||TWO_SIDED|95.0|-0.26|0.32|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 141||0.32|-0.26|
70856580|NCT02296138|141199779|SUPERIORITY||Ratio of events vs. Tiotropium 5 μg|0.89||||0.1265|TWO_SIDED|95.0|0.76|1.03|||Negative binomial model||Ratio of events Tiotropium (5 μg) + Olodaterol (5 μg) versus Tiotropium (5 μg) is provided.|Annualised rate of exacerbations leading to hospitalization was analysed using a negative binomial model including the fixed, categorical effect of treatment as well as the logarithm of the treatment exposure as an offset.||1.03|0.76|0.1265
71085493|NCT00676403|141676639|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|6.07||0.7216||95.0|-14.1|9.8|||Mixed Models Analysis|||Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.8|-14.1|0.7216
71085494|NCT00676403|141676639|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|5.78||0.6188||95.0|-14.3|8.5|||Mixed Models Analysis|||Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.5|-14.3|0.6188
71085495|NCT00676403|141676639|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|5.9||0.8096||95.0|-10.2|13.0|||Mixed Models Analysis|||Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.0|-10.2|0.8096
71085496|NCT00676403|141676639|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.6|STANDARD_ERROR_OF_MEAN|6.01||0.0157||95.0|-26.5|-2.8|||Mixed Models Analysis|||Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-2.8|-26.5|0.0157
71085497|NCT00676403|141676639|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|5.79||0.6007||95.0|-14.4|8.4|||Mixed Models Analysis|||Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.4|-14.4|0.6007
71085498|NCT00676403|141676639|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.0|STANDARD_ERROR_OF_MEAN|6.15||0.1057||95.0|-22.1|2.1|||Mixed Models Analysis|||Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||2.1|-22.1|0.1057
71085499|NCT00676403|141676639|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|5.81||0.7764||95.0|-13.1|9.8|||Mixed Models Analysis|||Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.8|-13.1|0.7764
71085500|NCT00676403|141676639|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|5.93||0.7146||95.0|-13.9|9.5|||Mixed Models Analysis|||Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.5|-13.9|0.7146
71085501|NCT00676403|141676640|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.31||0.2978||95.0|-0.3|0.9|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.9|-0.3|0.2978
71085502|NCT00676403|141676640|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7242||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.7|-0.5|0.7242
71085503|NCT00676403|141676640|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.32||0.0773||95.0|-0.1|1.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.2|-0.1|0.0773
71085504|NCT00676403|141676640|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7831||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.7|-0.5|0.7831
71123316|NCT00989235|141752204|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.13|||||TWO_SIDED|95.0|-0.41|0.15|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 169||0.15|-0.41|
71123317|NCT00989235|141752204|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.12|||||TWO_SIDED|95.0|-0.38|0.13|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 197||0.13|-0.38|
70856581|NCT02296138|141199780|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.2773|TWO_SIDED|95.0|0.82|1.06|||Log Rank||Tiotropium (5 μg) + Olodaterol (5 μg) versus Tiotropium (5 μg)|A Cox's proportional hazard model was used to estimate the hazard ratio and the corresponding Confidence Interval. A log-rank test was used to obtain the p-value||1.06|0.82|0.2773
71123318|NCT00989235|141752204|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.04|||||TWO_SIDED|95.0|-0.32|0.25|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 225||0.25|-0.32|
71123319|NCT00989235|141752204|SUPERIORITY_OR_OTHER||Adjusted Difference|0.08|||||TWO_SIDED|95.0|-0.19|0.36|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 253||0.36|-0.19|
71123320|NCT00989235|141752204|SUPERIORITY_OR_OTHER||Adjusted Difference|0.13|||||TWO_SIDED|95.0|-0.12|0.38|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 281||0.38|-0.12|
71123321|NCT00989235|141752204|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.03|||||TWO_SIDED|95.0|-0.27|0.22|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 309||0.22|-0.27|
71123322|NCT00989235|141752204|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.03|||||TWO_SIDED|95.0|-0.37|0.31|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 337||0.31|-0.37|
71123323|NCT00989235|141752204|SUPERIORITY_OR_OTHER||Adjusted Difference|0.23|||||TWO_SIDED|95.0|-0.09|0.55|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 365||0.55|-0.09|
71123324|NCT00989235|141752205|SUPERIORITY_OR_OTHER||estimate of difference|0.4|||||TWO_SIDED|95.0|-17.2|18.0|||normal approximation|For 95% CI: normal approximation with continuity correction.||||18.0|-17.2|
71123325|NCT00989235|141752206|SUPERIORITY_OR_OTHER||estimate of difference|-8.6|||||TWO_SIDED|95.0|-20.3|3.2|||normal approximation|For 95% CI: normal approximation with continuity correction.||||3.2|-20.3|
71123326|NCT00989235|141752208|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.45|1.69|||Cox proportional hazards model||Hazard ratio determined by a Cox proportional hazards model with treatment as the only covariate.|Through Month 12||1.69|0.45|
71123327|NCT00989235|141752209|SUPERIORITY_OR_OTHER||estimate of difference|-1.1|||||TWO_SIDED|95.0|-12.9|10.7|||normal approximation|For 95% CI: normal approximation with continuity correction.||||10.7|-12.9|
71123328|NCT00989235|141752210|SUPERIORITY_OR_OTHER||estimate of difference|-7.7|||||TWO_SIDED|95.0|-22.6|7.3|||normal approximation|95% CI: normal approximation with continuity correction.||||7.3|-22.6|
71123329|NCT00989235|141752211|SUPERIORITY_OR_OTHER||estimate of difference|-10.6|||||TWO_SIDED|95.0|-31.1|10.0|||normal approximation|95% CI: normal approximation with continuity correction.||||10.0|-31.1|
71123330|NCT02266875|141752222|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||||||0.320
71123331|NCT02266875|141752223|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
71123332|NCT01318070|141752236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.179|||||TWO_SIDED|95.0|-0.224|-0.135||||||||-0.135|-0.224|
71123333|NCT01318070|141752236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|||||TWO_SIDED|95.0|-0.225|-0.135||||||||-0.135|-0.225|
71123334|NCT01318070|141752237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.363|||||TWO_SIDED|95.0|-0.434|-0.292||||||||-0.292|-0.434|
71123335|NCT01318070|141752237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.359|||||TWO_SIDED|95.0|-0.432|-0.287||||||||-0.287|-0.432|
71123336|NCT01318070|141752238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.588|||||TWO_SIDED|95.0|-0.692|-0.484||||||||-0.484|-0.692|
71123337|NCT01318070|141752238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.635|||||TWO_SIDED|95.0|-0.743|-0.526||||||||-0.526|-0.743|
71123338|NCT01318070|141752239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.83|||||TWO_SIDED|95.0|-13.2|-4.47||||||||-4.47|-13.20|
71123339|NCT01318070|141752239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.06|||||TWO_SIDED|95.0|-17.86|-8.26||||||||-8.26|-17.86|
71123340|NCT01318070|141752240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.24|||||TWO_SIDED|95.0|-16.22|-6.25||||||||-6.25|-16.22|
71123341|NCT01318070|141752240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.82|||||TWO_SIDED|95.0|-20.0|-9.63||||||||-9.63|-20.00|
71123342|NCT01318070|141752241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.88|||||TWO_SIDED|95.0|-18.09|-7.68||||||||-7.68|-18.09|
71123343|NCT01318070|141752241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.08|||||TWO_SIDED|95.0|-22.64|-11.53||||||||-11.53|-22.64|
71123344|NCT01318070|141752242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.46|||||TWO_SIDED|95.0|-18.51|-6.4||||||||-6.40|-18.51|
71123345|NCT01318070|141752242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.49|||||TWO_SIDED|95.0|-22.78|-10.19||||||||-10.19|-22.78|
71123346|NCT01318070|141752243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.31|||||TWO_SIDED|95.0|-21.51|-3.1||||||||-3.10|-21.51|
71123347|NCT01318070|141752243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.19|||||TWO_SIDED|95.0|-30.43|-11.95||||||||-11.95|-30.43|
71123348|NCT01318070|141752244|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.717|||||TWO_SIDED|95.0|-0.848|-0.586||||||||-0.586|-0.848|
71123349|NCT01318070|141752244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.773|||||TWO_SIDED|95.0|-0.913|-0.634||||||||-0.634|-0.913|
71123350|NCT02481713|141752282|NON_INFERIORITY|All analyses were two-tailed with alpha set at 0.05||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
71123351|NCT02481713|141752283|SUPERIORITY||Risk Ratio (RR)|1.46||||0.0001|TWO_SIDED|95.0|1.25|1.69|||Regression, zero-inflated Poisson|||||1.69|1.25|.0001
71123352|NCT00353873|141752324|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested using a one-sided significance level of 2.5%. If the lower confidence interval for the difference SFC-FP falls above -12 L/min the once daily SFC treatment combination was deemed to be statistically non-inferior. In the event that the lower confidence limit (2.5% 1-sided significance) exceeded 0, and using a separate closed testing procedure, superiority could be established.|Mean Difference (Net)|7.6|STANDARD_ERROR_OF_MEAN|3.01||0.012|TWO_SIDED|95.0|1.7|13.5|||ANCOVA|||||13.5|1.7|0.012
71085505|NCT00676403|141676640|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3291||95.0|-0.3|0.9|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.9|-0.3|0.3291
71085506|NCT00676403|141676640|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.31||0.3692||95.0|-0.3|0.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.9|-0.3|0.3692
71085507|NCT00676403|141676640|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7614||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.7|-0.5|0.7614
71085508|NCT00676403|141676640|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.32||0.0355||95.0|0.0|1.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.3|0.0|0.0355
71123353|NCT00353873|141752325|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested using a one-sided significance level of 2.5%. If the lower confidence interval for the difference SFC-FP falls above -12 L/min the once daily SFC treatment combination was deemed to be statistically non-inferior. In the event that the lower confidence limit (2.5% 1-sided significance) exceeded 0, and using a separate closed testing procedure, superiority could be established.|Mean Difference (Net)|9.3|STANDARD_ERROR_OF_MEAN|3.08||0.003|TWO_SIDED|95.0|3.2|15.3|||ANCOVA|||||15.3|3.2|0.003
71123354|NCT00353873|141752326|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.389|TWO_SIDED|95.0|0.7|2.4|||Regression, Logistic|||||2.4|0.7|0.389
71123355|NCT00353873|141752327|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.535|TWO_SIDED|95.0|0.7|1.9|||Regression, Logistic|||||1.9|0.7|0.535
70856582|NCT02296138|141199781|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.7357|TWO_SIDED|95.0|0.67|1.75|||Log Rank||Tiotropium (5 μg) + Olodaterol (5 μg) versus Tiotropium (5 μg)|A Cox's proportional hazard model was used to estimate the hazard ratio and the corresponding Confidence Interval. A log-rank test was used to obtain the p-value||1.75|0.67|0.7357
70856583|NCT00711516|141199782|SUPERIORITY_OR_OTHER||Median Difference (Net)|-241.8||||0.7382|TWO_SIDED|95.0|-2470.0|2102.3||The hierarchical testing procedure was employed to control the studywise error rate at 0.05.|Wilcoxon (Mann-Whitney)|The assumption of normality was violated (p-value ≤0.05), therefore the treatment comparison was made using a Wilcoxon rank-sum test.||Using the standardized difference of 1.10, 28 evaluable patients (14 per treatment group) were required to provide 80% power while controlling the 2-sided, Type 1 error rate at 0.05. With an estimated 25% attrition rate, a total of 38 patients (19 per group) were planned. First analyzed using ANCOVA,the residuals were used to test for normality using Shapiro-Wilk; normality was violated therefore treatment comparison used the Wilcoxon rank sum.||2102.3|-2470.0|0.7382
70856584|NCT00711516|141199783|SUPERIORITY_OR_OTHER||Median Difference (Net)|53.2||||0.1661|TWO_SIDED|95.0|-17.8|136.1|||Wilcoxon (Mann-Whitney)|||The statistical hypothesis for this key secondary efficacy variable was to be tested using the same model as specified for the primary objective efficacy variable (ANCOVA, ANOVA, and Wilcoxon as appropriate). All statistical tests were 2 tailed at the 0.05 level of significance.||136.1|-17.8|0.1661
70856585|NCT00711516|141199784|SUPERIORITY_OR_OTHER||Median Difference (Net)|78.9||||0.5774|TWO_SIDED|95.0|-157.8|311.3|||Wilcoxon (Mann-Whitney)|||||311.3|-157.8|0.5774
70856586|NCT00711516|141199785|SUPERIORITY_OR_OTHER||Median Difference (Net)|90.1||||0.861|TWO_SIDED|95.0|-806.7|707.0|||Wilcoxon (Mann-Whitney)|||||707.0|-806.7|0.8610
71123356|NCT00870194|141752333|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority Margin of 0.4%||||||0.012||95.0|||||Mixed Model Repeated Measures|||||||.012
70944908|NCT01917006|141390477|SUPERIORITY||Least square mean difference|14.12||||0.424||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 6||||0.424
71123357|NCT00870194|141752333|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.4%|Least Square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.12||0.012|TWO_SIDED|95.0|0.07|0.53|||Mixed Model Repeated Measures||Standard Error of the Least Square Mean|Power calculation: 80% assuming 200 patients (100 in each arm), no true difference and 1.0% standard deviation.||0.53|0.07|.012
71123358|NCT00870194|141752334|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||Fisher's Exact Test|||||||.038
70856587|NCT00711516|141199786|SUPERIORITY_OR_OTHER||Median Difference (Net)|252.8||||0.6907|TWO_SIDED|95.0|-1066.5|1523.8|||Wilcoxon (Mann-Whitney)|||||1523.8|-1066.5|0.6907
70856588|NCT00711516|141199787|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.2456|TWO_SIDED|95.0|-8.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-8.0|0.2456
70856589|NCT00711516|141199788|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.7115|TWO_SIDED|95.0|-8.0|9.0|||Wilcoxon (Mann-Whitney)|||||9.0|-8.0|0.7115
70944909|NCT01917006|141390477|SUPERIORITY||Least square mean difference|136.96||||0.026||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 6||||0.026
71123359|NCT00870194|141752335|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||Fisher's Exact Test|||||||.027
71123360|NCT00870194|141752336|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Fisher's Exact Test|||||||.480
71123361|NCT00870194|141752337|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||ANCOVA|||||||.038
71123362|NCT00870194|141752338|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||Mixed Model Repeated Measures|||||||.266
70944910|NCT01917006|141390477|SUPERIORITY||Least square mean difference|-27.62||||0.67||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 6||||0.670
71085509|NCT00676403|141676640|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.5068||95.0|-0.4|0.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.8|-0.4|0.5068
71085510|NCT00676403|141676640|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.31||0.0561||95.0|0.0|1.2|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.2|-0.0|0.0561
71085511|NCT00676403|141676640|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.31||0.2223||95.0|-0.2|1.0|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.0|-0.2|0.2223
71085512|NCT00676403|141676640|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.6791||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.7|-0.5|0.6791
71085513|NCT00676403|141676640|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|0.32||0.0188||95.0|0.1|1.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.4|0.1|0.0188
71085514|NCT00676403|141676640|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.3||0.1314||95.0|-0.1|1.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.1|-0.1|0.1314
71085515|NCT00676403|141676640|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.31||0.09||95.0|-0.1|1.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.1|-0.1|0.0900
71085516|NCT00676403|141676640|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.31||0.4144||95.0|-0.4|0.9|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.9|-0.4|0.4144
71123363|NCT00870194|141752339|SUPERIORITY_OR_OTHER|||||||0.095||95.0|||||Mixed Model Repeated Measures|||||||.095
71123364|NCT00870194|141752340|SUPERIORITY_OR_OTHER|||||||0.567||95.0|||||Mixed Model Repeated Measures|||||||.567
71123365|NCT00870194|141752341|SUPERIORITY_OR_OTHER|||||||0.207||95.0|||||Mixed Model Repeated Measures|||||||.207
71123366|NCT00870194|141752342|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||ANCOVA|||||||.055
71123367|NCT00870194|141752343|SUPERIORITY_OR_OTHER|||||||0.269||95.0|||||ANCOVA|||||||.269
71123368|NCT00870194|141752344|SUPERIORITY_OR_OTHER|||||||0.622||95.0|||||ANCOVA|||||||.622
71123369|NCT00870194|141752345|SUPERIORITY_OR_OTHER|||||||0.888||95.0|||||ANCOVA|||||||.888
71123370|NCT00870194|141752346|SUPERIORITY_OR_OTHER|||||||0.287||95.0|||||Fisher's Exact Test|||||||.287
71123371|NCT00870194|141752347|SUPERIORITY_OR_OTHER|||||||0.498||95.0|||||Fisher's Exact Test|||||||.498
71123372|NCT00870194|141752348|SUPERIORITY_OR_OTHER|||||||0.247||95.0|||||Fisher's Exact Test|||||||.247
71123373|NCT00870194|141752349|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher's Exact Test|||||||1.00
71123374|NCT00554099|141752351|SUPERIORITY_OR_OTHER||Mean Difference vs. Placebo|-3.0|STANDARD_ERROR_OF_MEAN|1.69||0.3781|ONE_SIDED|90.0||-0.809|||ANCOVA|Fixed effects for treatment, number of diverticulitis attacks and baseline value as covariate.||It was assumed that the placebo treatment group and mesalamine treatment group would have an average composite score of 8.4 and 5.88 at Week 12, respectively. The common standard deviation was set to 4.5 based on the 2 standard deviation rule. Based on these assumptions, 60 patients per treatment group required to detect 30% treatment difference at 1-sided, 0.1 level of significance, with 80% power.||-0.809||0.3781
71123375|NCT00554099|141752351|SUPERIORITY_OR_OTHER||Mean Difference vs. Placebo|-1.4|STANDARD_ERROR_OF_MEAN|1.74||0.6285|ONE_SIDED|90.0||0.815|||ANCOVA|Fixed effects for treatment, number of diverticulitis attacks and baseline value as covariate.||It was assumed that the placebo treatment group and mesalamine treatment group would have an average composite score of 8.4 and 5.88 at Week 12, respectively. The common standard deviation was set to 4.5 based on the 2 standard deviation rule. Based on these assumptions, 60 patients per treatment group required to detect 30% treatment difference at 1-sided, 0.1 level of significance, with 80% power.||0.815||0.6285
70856590|NCT00711516|141199789|SUPERIORITY_OR_OTHER||Median Difference (Net)|4.0||||0.6103|TWO_SIDED|95.0|-13.0|19.0|||Wilcoxon (Mann-Whitney)|||||19.0|-13.0|0.6103
70856591|NCT00711516|141199790|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.9619|TWO_SIDED|95.0|-18.0|17.0|||Wilcoxon (Mann-Whitney)|||||17.0|-18.0|0.9619
70856592|NCT00711516|141199791|SUPERIORITY_OR_OTHER||Median Difference (Net)|-335.5||||0.4544|TWO_SIDED|95.0|-1270.7|723.3|||Wilcoxon (Mann-Whitney)|||||723.3|-1270.7|0.4544
71085517|NCT00676403|141676640|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7699||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.7|-0.5|0.7699
71085518|NCT00676403|141676640|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.32||0.0406||95.0|0.0|1.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.3|0.0|0.0406
70856593|NCT00711516|141199792|SUPERIORITY_OR_OTHER||Median Difference (Net)|6410.3||||0.0193|TWO_SIDED|95.0|1064.7|12087.3|||Wilcoxon (Mann-Whitney)|||||12087.3|1064.7|0.0193
70856594|NCT00711516|141199793|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.1704|TWO_SIDED|95.0|-0.1|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.1|0.1704
70856595|NCT00711516|141199794|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.2||||0.0609|TWO_SIDED|95.0|-0.3|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.3|0.0609
70872018|NCT01652703|141229475|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-52.85|STANDARD_ERROR_OF_MEAN|3.03|<|0.001|TWO_SIDED|95.0|-58.84|-46.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-46.86|-58.84|<0.001
71085519|NCT00676403|141676640|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7574||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.7|-0.5|0.7574
71085520|NCT00676403|141676640|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.31||0.0554||95.0|0.0|1.2|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.2|-0.0|0.0554
71085521|NCT00676403|141676641|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|5.36||0.5409||95.0|-13.8|7.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.3|-13.8|0.5409
71085522|NCT00676403|141676641|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|5.25||0.823||95.0|-11.5|9.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.2|-11.5|0.8230
71085523|NCT00676403|141676641|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.7|STANDARD_ERROR_OF_MEAN|5.48||0.2958||95.0|-16.5|5.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.1|-16.5|0.2958
71085524|NCT00676403|141676641|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|5.27||0.3708||95.0|-15.1|5.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.7|-15.1|0.3708
71085525|NCT00676403|141676641|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|5.27||0.1853||95.0|-17.4|3.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.4|-17.4|0.1853
70856596|NCT00711516|141199795|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9||||0.0499|TWO_SIDED|95.0|-5.8|0.0||Nominal P-value for treatment comparison is from an analysis of covariance (ANCOVA) with treatment and center as factors and the baseline value as covariate.|ANCOVA|||Hierarchical testing procedure was used to control the studywise error rate at 0.05. If treatment was statistically significant on the primary variable, the key secondary variable would be claimed as significant if p-value was \<= 0.05. If primary and key secondary variables were significant subsequent secondary variables following the order presented here would be claimed as significant if their p-values were \<= 0.05. If any were \>0.05 subsequent p-values would be reported as nominal p-values.||-0.0|-5.8|0.0499
70856597|NCT00711516|141199796|SUPERIORITY_OR_OTHER|||||||0.7343||95.0|||||Fisher Exact|||||||0.7343
70856598|NCT00711516|141199797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.2||||0.1246|TWO_SIDED|95.0|-1.8|14.3||P-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment and center as factors and the baseline value as a covariate.|ANCOVA|||||14.3|-1.8|0.1246
70856599|NCT00711516|141199798|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.026||||0.7382|TWO_SIDED|95.0|-21.684|19.98|||Wilcoxon (Mann-Whitney)|||||19.980|-21.684|0.7382
70944911|NCT01917006|141390477|SUPERIORITY||Least square mean difference|-10.06||||0.561||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 6||||0.561
71085526|NCT00676403|141676641|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.2|STANDARD_ERROR_OF_MEAN|5.41||0.1834||95.0|-17.9|3.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.4|-17.9|0.1834
70856600|NCT00711516|141199799|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.086||||1|TWO_SIDED|95.0|-19.195|25.043|||Wilcoxon (Mann-Whitney)|||||25.043|-19.195|1.000
70856601|NCT00711516|141199800|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.282||||0.8861|TWO_SIDED|95.0|-11.46|14.77|||Wilcoxon (Mann-Whitney)|||||14.770|-11.460|0.8861
70856602|NCT00711516|141199801|SUPERIORITY_OR_OTHER||Median Difference (Net)|11.825||||0.4738|TWO_SIDED|95.0|-12.601|37.987|||Wilcoxon (Mann-Whitney)|||||37.987|-12.601|0.4738
70944912|NCT01917006|141390477|SUPERIORITY||Least square mean difference|-16.58||||0.604||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 6||||0.604
70944913|NCT01917006|141390477|SUPERIORITY||Least square mean difference|17.76||||0.394||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 6||||0.394
71123376|NCT00554099|141752351|SUPERIORITY_OR_OTHER||Mean Difference vs. Asacol|1.6|STANDARD_ERROR_OF_MEAN|1.58||0.4365|ONE_SIDED|90.0||3.573|||ANCOVA|Fixed effects for treatment, number of diverticulitis attacks and baseline value as covariate.||It was assumed that the placebo treatment group and mesalamine treatment group would have an average composite score of 8.4 and 5.88 at Week 12, respectively. The common standard deviation was set to 4.5 based on the 2 standard deviation rule. Based on these assumptions, 60 patients per treatment group required to detect 30% treatment difference at 1-sided, 0.1 level of significance, with 80% power.||3.573||0.4365
71123377|NCT00554099|141752352|SUPERIORITY_OR_OTHER||Difference vs. Placebo|21.1|STANDARD_ERROR_OF_MEAN|12.53||0.0576|ONE_SIDED|90.0|5.1||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||||5.1|0.0576
71123378|NCT00554099|141752352|SUPERIORITY_OR_OTHER||Difference vs. Placebo|6.8|STANDARD_ERROR_OF_MEAN|13.27||0.3248|ONE_SIDED|90.0|-10.2||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||||-10.2|0.3248
71123379|NCT00554099|141752352|SUPERIORITY_OR_OTHER||Difference vs. Mesalamine|-14.4|STANDARD_ERROR_OF_MEAN|12.87||0.8596|ONE_SIDED|90.0|-30.8||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||||-30.8|0.8596
71123380|NCT00554099|141752353|SUPERIORITY_OR_OTHER||Difference vs. Placebo|16.7|STANDARD_ERROR_OF_MEAN|14.0||0.1266|ONE_SIDED|90.0|-1.3||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||||-1.3|0.1266
71123381|NCT00554099|141752353|SUPERIORITY_OR_OTHER||Difference vs. Placebo|-20.8|STANDARD_ERROR_OF_MEAN|14.13||0.9288|ONE_SIDED|90.0|-38.9||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||||-38.9|0.9288
71123382|NCT00554099|141752353|SUPERIORITY_OR_OTHER||Difference vs. Placebo|-37.5|STANDARD_ERROR_OF_MEAN|12.98||0.9962|ONE_SIDED|90.0|-54.1||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||||-54.1|0.9962
71123383|NCT00554099|141752354|SUPERIORITY_OR_OTHER||LS Mean Difference vs. Placebo|-1.4|STANDARD_ERROR_OF_MEAN|2.784||0.3082|ONE_SIDED|90.0||2.196|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.||||2.196||0.3082
71123384|NCT00554099|141752354|SUPERIORITY_OR_OTHER||LS Mean Difference vs. Placebo|0.083|STANDARD_ERROR_OF_MEAN|2.903||0.5113|ONE_SIDED|90.0||3.832|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.||||3.832||0.5113
71123385|NCT00554099|141752354|SUPERIORITY_OR_OTHER||LS Mean Difference vs. Mesalamine|1.483|STANDARD_ERROR_OF_MEAN|2.836||0.6988|ONE_SIDED|90.0||5.145|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.||||5.145||0.6988
71123386|NCT00554099|141752355|SUPERIORITY_OR_OTHER||LS Mean Difference vs. Placebo|-0.428|STANDARD_ERROR_OF_MEAN|3.067||0.4448|ONE_SIDED|90.0||3.541|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.||||3.541||0.4448
70856603|NCT00711516|141199802|SUPERIORITY_OR_OTHER|||||||0.0573||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||Pearson's correlation coefficient was used to assess the relationship between fMRI variable and performance on the 2-back working memory test||||0.0573
70944914|NCT01917006|141390477|SUPERIORITY||Least square mean difference|-5.94||||0.532||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 8||||0.532
70944915|NCT01917006|141390477|SUPERIORITY||Least square mean difference|111.27||||0.058||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 8||||0.058
71123387|NCT00554099|141752355|SUPERIORITY_OR_OTHER||LS Mean Difference vs. Placebo|0.825|STANDARD_ERROR_OF_MEAN|3.151||0.6029|ONE_SIDED|90.0||4.903|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.||||4.903||0.6029
71123388|NCT00554099|141752355|SUPERIORITY_OR_OTHER||LS Mean Difference vs. Mesalamine|1.253|STANDARD_ERROR_OF_MEAN|2.996||0.6615|ONE_SIDED|90.0||5.129|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.||||5.129||0.6615
71123389|NCT00554099|141752356|SUPERIORITY_OR_OTHER||Difference vs. Placebo|2.6|STANDARD_ERROR_OF_MEAN|4.2||0.7165|ONE_SIDED|90.0||7.9|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||7.9||0.7165
71123390|NCT00554099|141752356|SUPERIORITY_OR_OTHER||Difference vs. Placebo|-2.4|STANDARD_ERROR_OF_MEAN|2.41||0.1708|ONE_SIDED|90.0||0.6|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||0.6||0.1708
71123391|NCT00554099|141752356|SUPERIORITY_OR_OTHER||Difference vs. Mesalamine|-5.0|STANDARD_ERROR_OF_MEAN|3.45||0.1039|ONE_SIDED|90.0||-0.6|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||-0.6||0.1039
71123392|NCT00554099|141752357|SUPERIORITY_OR_OTHER||Difference vs. Placebo|-7.5|STANDARD_ERROR_OF_MEAN|8.21||0.1907|ONE_SIDED|90.0||3.0|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||3.0||0.1907
71123393|NCT00554099|141752357|SUPERIORITY_OR_OTHER||Difference vs. Placebo|-8.2|STANDARD_ERROR_OF_MEAN|8.4||0.173|ONE_SIDED|90.0||2.5|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||2.5||0.1730
71085527|NCT00676403|141676641|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|5.22||0.8711||95.0|-11.1|9.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.4|-11.1|0.8711
70944916|NCT01917006|141390477|SUPERIORITY||Least square mean difference|-48.65||||0.778||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 8||||0.778
71085528|NCT00676403|141676641|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.4|STANDARD_ERROR_OF_MEAN|5.5||0.3252||95.0|-16.3|5.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.4|-16.3|0.3252
71085529|NCT00676403|141676641|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|5.28||0.3205||95.0|-15.7|5.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.1|-15.7|0.3205
71085530|NCT00676403|141676641|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.3|STANDARD_ERROR_OF_MEAN|5.34||0.0837||95.0|-19.8|1.2|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.2|-19.8|0.0837
71085531|NCT00676403|141676641|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|5.4||0.8895||95.0|-11.4|9.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.9|-11.4|0.8895
71085532|NCT00676403|141676641|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|5.22||0.6469||95.0|-12.7|7.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.9|-12.7|0.6469
71085533|NCT00676403|141676641|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|5.53||0.2687||95.0|-17.0|4.8|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.8|-17.0|0.2687
71085534|NCT00676403|141676641|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.2|STANDARD_ERROR_OF_MEAN|5.31||0.1757||95.0|-17.7|3.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.3|-17.7|0.1757
71085535|NCT00676403|141676641|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.7|STANDARD_ERROR_OF_MEAN|5.38||0.0306||95.0|-22.3|-1.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-1.1|-22.3|0.0306
71085536|NCT00676403|141676641|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.4|STANDARD_ERROR_OF_MEAN|5.47||0.0857||95.0|-20.2|1.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.3|-20.2|0.0857
71123394|NCT00554099|141752357|SUPERIORITY_OR_OTHER||Difference vs. Mesalamine|-0.7|STANDARD_ERROR_OF_MEAN|7.61||0.4613|ONE_SIDED|90.0||9.0|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||9.0||0.4613
71123395|NCT00554099|141752358|SUPERIORITY_OR_OTHER||Difference vs. Placebo|-2.9|STANDARD_ERROR_OF_MEAN|11.7||0.3983|ONE_SIDED|90.0||12.1|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||12.1||0.3983
71123396|NCT00554099|141752358|SUPERIORITY_OR_OTHER||Difference vs. Placebo|6.0|STANDARD_ERROR_OF_MEAN|12.66||0.6721|ONE_SIDED|90.0||22.2|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||22.2||0.6721
71123397|NCT00554099|141752358|SUPERIORITY_OR_OTHER||Difference vs. Mesalamine|8.9|STANDARD_ERROR_OF_MEAN|12.23||0.7703|ONE_SIDED|90.0||24.6|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||24.6||0.7703
71123398|NCT01443130|141752359|SUPERIORITY_OR_OTHER|||||||0.2441||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025|Fisher Exact|||The null hypothesis is the incidence of placental malaria infection based on histology is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.2441
70856604|NCT00711516|141199802|SUPERIORITY_OR_OTHER|||||||0.0754||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||.0754
70856605|NCT00711516|141199803|SUPERIORITY_OR_OTHER|||||||0.2727||95.0|||||Pearson's Correlation Coefficient|||||||0.2727
70856606|NCT00711516|141199803|SUPERIORITY_OR_OTHER|||||||0.5671||95.0|||||Pearson's Correlation Coefficient|||||||.5671
70856607|NCT00711516|141199804|SUPERIORITY_OR_OTHER|||||||0.1169||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||0.1169
70856608|NCT00711516|141199804|SUPERIORITY_OR_OTHER|||||||0.1634||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||0.1634
70856609|NCT00711516|141199805|SUPERIORITY_OR_OTHER|||||||0.0692||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's Z-transformation.||||||0.0692
71123399|NCT01443130|141752359|SUPERIORITY_OR_OTHER|||||||1||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025|Fisher Exact|||The null hypothesis is the incidence of placental malaria infection based on histology is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||1.000
71123400|NCT01443130|141752360|SUPERIORITY_OR_OTHER|||||||0.4941||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of malaria by placental impression smear is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.4941
71123401|NCT01443130|141752360|SUPERIORITY_OR_OTHER|||||||0.499||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of malaria by placental impression smear is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.4990
71123402|NCT01443130|141752361|SUPERIORITY_OR_OTHER|||||||0.3089||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of maternal anemia is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.3089
71123403|NCT01443130|141752361|SUPERIORITY_OR_OTHER|||||||0.6973||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of maternal anemia is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.6973
70856610|NCT00711516|141199805|SUPERIORITY_OR_OTHER|||||||0.8876||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||.8876
70856611|NCT00711516|141199806|SUPERIORITY_OR_OTHER|||||||0.603||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's Z-transformation.||||||0.6030
70856612|NCT00711516|141199806|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||<.0001
70856613|NCT00711516|141199807|SUPERIORITY_OR_OTHER|||||||0.917||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's Z-transformation.||||||0.9170
70856614|NCT00711516|141199807|SUPERIORITY_OR_OTHER|||||||0.9642||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||.9642
70856615|NCT00711516|141199808|SUPERIORITY_OR_OTHER|||||||0.7813||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||0.7813
71085537|NCT00676403|141676641|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|5.28||0.2932||95.0|-16.0|4.8|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.8|-16.0|0.2932
71085538|NCT00676403|141676641|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.5|STANDARD_ERROR_OF_MEAN|5.6||0.0613||95.0|-21.6|0.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.5|-21.6|0.0613
71085539|NCT00676403|141676641|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|5.34||0.5431||95.0|-13.8|7.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.3|-13.8|0.5431
71085540|NCT00676403|141676641|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.1|STANDARD_ERROR_OF_MEAN|5.41||0.0262||95.0|-22.7|-1.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-1.4|-22.7|0.0262
70856616|NCT00711516|141199808|SUPERIORITY_OR_OTHER|||||||0.156||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||0.1560
71085541|NCT00676403|141676642|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.8|STANDARD_ERROR_OF_MEAN|5.44||0.1547||95.0|-18.5|3.0|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.0|-18.5|0.1547
71123404|NCT01443130|141752362|SUPERIORITY_OR_OTHER|||||||1||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of maternal severe anemia is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||1.00
71085542|NCT00676403|141676642|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|5.33||0.2532||95.0|-16.6|4.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.4|-16.6|0.2532
71123405|NCT01443130|141752362|SUPERIORITY_OR_OTHER|||||||1||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of maternal severe anemia is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||1.00
71123406|NCT01443130|141752363|SUPERIORITY_OR_OTHER|||||||0.4979||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of stillbirth is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.4979
71123407|NCT01443130|141752363|SUPERIORITY_OR_OTHER|||||||0.1166||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of stillbirth is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.1166
71123408|NCT01443130|141752364|SUPERIORITY_OR_OTHER|||||||0.6237||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of miscarriage is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.6237
71123409|NCT01443130|141752364|SUPERIORITY_OR_OTHER|||||||1||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of miscarriage is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||1.000
71123410|NCT01443130|141752365|SUPERIORITY_OR_OTHER|||||||0.5187||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of preterm delivery is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.5187
71123411|NCT01443130|141752365|SUPERIORITY_OR_OTHER|||||||0.2163||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of preterm delivery is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.2163
71123412|NCT01443130|141752366|SUPERIORITY_OR_OTHER|||||||0.5959||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of infant mortality within 14 weeks of delivery is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.5959
71123413|NCT01443130|141752366|SUPERIORITY_OR_OTHER|||||||0.8127||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of infant mortality within 14 weeks of delivery is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.8127
71123414|NCT01443130|141752367|SUPERIORITY_OR_OTHER|||||||0.2566||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of low birth weight is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.2566
71123415|NCT01443130|141752367|SUPERIORITY_OR_OTHER|||||||0.7839||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of low birth weight is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.7839
71123416|NCT01443130|141752368|SUPERIORITY_OR_OTHER|||||||0.2553||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of intrauterine growth restriction is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.2553
71123417|NCT01443130|141752368|SUPERIORITY_OR_OTHER|||||||0.4354||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of intrauterine growth restriction is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.4354
71123418|NCT01443130|141752369|SUPERIORITY_OR_OTHER|||||||0.369||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of active placental malaria infection is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.3690
71123419|NCT01443130|141752369|SUPERIORITY_OR_OTHER|||||||0.4947||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of active placental malaria infection is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.4947
70856617|NCT00711516|141199809|SUPERIORITY_OR_OTHER|||||||0.901||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||0.9010
71085543|NCT00676403|141676642|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|5.56||0.0848||95.0|-20.6|1.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.3|-20.6|0.0848
71085544|NCT00676403|141676642|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.3|STANDARD_ERROR_OF_MEAN|5.36||0.2424||95.0|-16.8|4.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.3|-16.8|0.2424
71085545|NCT00676403|141676642|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.7|STANDARD_ERROR_OF_MEAN|5.35||0.047||95.0|-21.2|-0.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.1|-21.2|0.0470
71085546|NCT00676403|141676642|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|5.49||0.1494||95.0|-18.8|2.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||2.9|-18.8|0.1494
71085547|NCT00676403|141676642|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|5.3||0.5081||95.0|-13.9|6.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||6.9|-13.9|0.5081
71085548|NCT00676403|141676642|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|5.58||0.2141||95.0|-17.9|4.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.0|-17.9|0.2141
71085549|NCT00676403|141676642|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.8|STANDARD_ERROR_OF_MEAN|5.37||0.1484||95.0|-18.4|2.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||2.8|-18.4|0.1484
71085550|NCT00676403|141676642|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.0|STANDARD_ERROR_OF_MEAN|5.42||0.0963||95.0|-19.7|1.6|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.6|-19.7|0.0963
71085551|NCT00676403|141676642|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|5.48||0.8519||95.0|-11.8|9.8|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.8|-11.8|0.8519
71085552|NCT00676403|141676642|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|5.3||0.477||95.0|-14.2|6.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||6.7|-14.2|0.4770
71085553|NCT00676403|141676642|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|5.61||0.2166||95.0|-18.0|4.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.1|-18.0|0.2166
70856618|NCT00711516|141199809|SUPERIORITY_OR_OTHER|||||||0.0135||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||0.0135
71085554|NCT00676403|141676642|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|5.4||0.1062||95.0|-19.4|1.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.9|-19.4|0.1062
71085555|NCT00676403|141676642|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.9|STANDARD_ERROR_OF_MEAN|5.45||0.0475||95.0|-21.6|-0.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.1|-21.6|0.0475
70856619|NCT00711516|141199818|SUPERIORITY_OR_OTHER||Median Difference (Net)|4.841||||0.7053|TWO_SIDED|95.0|-27.778|19.313|||Wilcoxon (Mann-Whitney)|||||19.313|-27.778|0.7053
71085556|NCT00676403|141676642|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.7|STANDARD_ERROR_OF_MEAN|5.54||0.0537||95.0|-21.7|0.2|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.2|-21.7|0.0537
71085557|NCT00676403|141676642|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.4|STANDARD_ERROR_OF_MEAN|5.35||0.3153||95.0|-15.9|5.2|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.2|-15.9|0.3153
71085558|NCT00676403|141676642|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|5.68||0.0424||95.0|-22.8|-0.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.4|-22.8|0.0424
71085559|NCT00676403|141676642|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|5.42||0.3077||95.0|-16.2|5.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.1|-16.2|0.3077
71085560|NCT00676403|141676642|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.6|STANDARD_ERROR_OF_MEAN|5.48||0.0224||95.0|-23.4|-1.8|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-1.8|-23.4|0.0224
71085561|NCT00676403|141676643|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.7|STANDARD_ERROR_OF_MEAN|2.65||0.0646||95.0|0.9|15.0|||Regression, Logistic|||Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||15.0|0.9|0.0646
71085562|NCT00676403|141676643|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.2|STANDARD_ERROR_OF_MEAN|1.58||0.2947||95.0|0.5|9.1|||Regression, Logistic|||Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||9.1|0.5|0.2947
71085563|NCT00676403|141676643|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.6|STANDARD_ERROR_OF_MEAN|3.1||0.0249||95.0|1.2|17.2|||Regression, Logistic|||Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||17.2|1.2|0.0249
71085564|NCT00676403|141676643|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.3|STANDARD_ERROR_OF_MEAN|0.99||0.7671||95.0|0.3|5.9|||Regression, Logistic|||Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||5.9|0.3|0.7671
70856620|NCT00711516|141199819|SUPERIORITY_OR_OTHER||Median Difference (Net)|4.792||||0.5163|TWO_SIDED|95.0|-30.631|16.19|||Wilcoxon (Mann-Whitney)|||||16.190|-30.631|0.5163
70856621|NCT00711516|141199820|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.108||||0.8711|TWO_SIDED|95.0|-14.341|5.498|||Wilcoxon (Mann-Whitney)|||||5.498|-14.341|0.8711
71123420|NCT01443130|141752370|SUPERIORITY_OR_OTHER|||||||0.063||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of malaria infection (all species) measured by positive parasitemia is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.0630
71123421|NCT01443130|141752370|SUPERIORITY_OR_OTHER|||||||0.4184||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of malaria infection (all species) measured by positive parasitemia is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.4184
71123422|NCT01443130|141752371|SUPERIORITY_OR_OTHER|||||||0.0268||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Cox proportional hazards|||The null hypothesis is the incidence of clinical malaria (all species) is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.0268
71123423|NCT01443130|141752371|SUPERIORITY_OR_OTHER|||||||0.1646||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Cox proportional hazards|||The null hypothesis is the incidence of clinical malaria (all species) is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.1646
71123424|NCT01443130|141752372|SUPERIORITY_OR_OTHER|||||||0.4501||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of infection in the fetal circulation is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.4501
71123425|NCT01443130|141752372|SUPERIORITY_OR_OTHER|||||||0.1758||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of infection in the fetal circulation is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.1758
71123426|NCT02818114|141752374|OTHER|Assessment of number of PE sessions attended, review of direction of change in PTSD Checklist scores||||||||||||||||This is a single-arm feasibility study. With N=8, formal hypothesis testing is not possible. We were assessing the extent to which veterans would be willing to engage in the intervention, and if the direction of change in symptoms is still in the expected direction when peer support services are added. Outcomes are reported more qualitatively.|As a feasibility trial, tests of statistical significance are not appropriate.|||
71123427|NCT03461406|141752389|NON_INFERIORITY|The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% confidence interval (CI) exceeds 0.8.|Relative risk|1.0|||<|0.001|TWO_SIDED|95.0|0.92|1.09|||Cochran-Mantel-Haenszel|||Hemostasis by 4 Minutes (Parenchymous)||1.09|0.92|< 0.001
71123428|NCT03461406|141752389|NON_INFERIORITY|The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% CI exceeds 0.8|Relative risk|1.03|||<|0.001|TWO_SIDED|95.0|0.91|1.16|||Cochran-Mantel-Haenszel|||Hemostasis by 4 Minutes (Soft Tissue)||1.16|0.91|< 0.001
71123429|NCT03461406|141752390|NON_INFERIORITY|The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% confidence interval (CI) exceeds 0.8.|Relative risk|1.0|||<|0.001|TWO_SIDED|95.0|0.92|1.09|||Cochran-Mantel-Haenszel|||Hemostasis by 7 Minutes (Parenchymous)||1.09|0.92|< 0.001
71123430|NCT03461406|141752390|NON_INFERIORITY|The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% confidence interval (CI) exceeds 0.8.|Relative risk|1.0|||<|0.001|TWO_SIDED|95.0|0.92|1.09|||Cochran-Mantel-Haenszel|||Hemostasis by 7 Minutes (Soft tissue)||1.09|0.92|< 0.001
70856622|NCT00711516|141199821|SUPERIORITY_OR_OTHER||Median Difference (Net)|13.855||||0.1825||95.0|-15.357|25.714|||Wilcoxon (Mann-Whitney)|||||25.714|-15.357|0.1825
70856623|NCT00711516|141199822|SUPERIORITY_OR_OTHER||Median Difference (Net)|-323.5||||0.9282|TWO_SIDED|95.0|-9311.0|2375.5|||Wilcoxon (Mann-Whitney)|||||2375.5|-9311.0|0.9282
70856624|NCT00711516|141199823|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0||||1|TWO_SIDED|95.0|-1069.0|426.0|||Wilcoxon (Mann-Whitney)|||||426.0|-1069.0|1.0000
71123431|NCT03461406|141752391|NON_INFERIORITY|The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% CI exceeds 0.8.|Relative risk|0.98|||<|0.001|TWO_SIDED|95.0|0.94|1.02|||Cochran-Mantel-Haenszel|||Hemostasis by 10 Minutes (Parenchymous)||1.02|0.94|< 0.001
71123432|NCT03461406|141752391|NON_INFERIORITY|The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% CI exceeds 0.8.|Relative risk|1.0|||<|0.001|TWO_SIDED|95.0|0.92|1.09|||Cochran-Mantel-Haenszel|||Hemostasis by 10 Minutes (Soft tissue)||1.09|0.92|< 0.001
71123433|NCT02008357|141752403|SUPERIORITY||LS Mean difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.26||0.26|TWO_SIDED|95.0|-0.816|0.22|||Natural Cubic Spline (NCS) method|||||0.220|-0.816|0.260
71123434|NCT02008357|141752405|SUPERIORITY||LS Mean difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.28||0.1|TWO_SIDED|95.0|-0.089|1.02|||Natural Cubic Spline (NCS) method|||||1.020|-0.089|0.100
71123435|NCT02008357|141752407|SUPERIORITY||LS Mean difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.34||0.082|TWO_SIDED|95.0|-1.265|0.076|||Natural Cubic Spline (NCS) method|||||0.076|-1.265|0.082
71123436|NCT02008357|141752409|SUPERIORITY||LS Mean difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.0073|<|0.001|TWO_SIDED|95.0|-0.057|-0.028|||ANCOVA|||||-0.028|-0.057|<0.001
71123437|NCT02008357|141752410|SUPERIORITY||LS Mean difference (Final Values)|3.239|STANDARD_ERROR_OF_MEAN|32.8719||0.922|TWO_SIDED|95.0|-62.02|68.498|||ANCOVA|||Cerebrospinal fluid Tau Protein Immunoassay||68.498|-62.020|0.922
71123438|NCT02008357|141752410|SUPERIORITY||LS Mean difference (Final Values)|-0.965|STANDARD_ERROR_OF_MEAN|2.6535||0.717|TWO_SIDED|95.0|-6.241|4.311|||ANCOVA|||Cerebrospinal Fluid Phosphorylated Tau Protein Immunoassay||4.311|-6.241|0.717
71123439|NCT02008357|141752411|SUPERIORITY||LS Mean difference (Final Values)|12738.449|STANDARD_ERROR_OF_MEAN|998.7048|<|0.001|TWO_SIDED|95.0|10757.047|14719.851|||ANCOVA|||Cerebrospinal Fluid Amyloid Beta 1-40 Modified ELISA - INNOTEST||14719.851|10757.047|<0.001
71123440|NCT02008357|141752411|SUPERIORITY||LS Mean difference (Final Values)|996.411|STANDARD_ERROR_OF_MEAN|60.7404|<|0.001|TWO_SIDED|95.0|875.873|1116.948||p-value using ANCOVA model for endpoint measures: CHG = Baseline + APOE4 + AGE + Treatment.|ANCOVA|||Cerebrospinal Fluid Amyloid Beta 1-42 Mod Modified ELISA - INNOTEST||1116.948|875.873|<0.001
70944917|NCT01917006|141390477|SUPERIORITY||Least square mean difference|-27.74||||0.662||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 8||||0.662
70944918|NCT01917006|141390477|SUPERIORITY||Least square mean difference|-35.72||||0.712||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 8||||0.712
70944919|NCT01917006|141390477|SUPERIORITY||Least square mean difference|-0.18||||0.501||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 8||||0.501
70944920|NCT01917006|141390477|SUPERIORITY||Least square mean difference|-12.14||||0.565||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 10||||0.565
70944921|NCT01917006|141390477|SUPERIORITY||Least square mean difference|102.44||||0.071||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 10||||0.071
70944922|NCT01917006|141390477|SUPERIORITY||Least square mean difference|-52.81||||0.799||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 10||||0.799
70944923|NCT01917006|141390477|SUPERIORITY||Least square mean difference|-30.81||||0.681||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 10||||0.681
70944924|NCT01917006|141390477|SUPERIORITY||Least square mean difference|-40.68||||0.741||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 10||||0.741
70944925|NCT01917006|141390477|SUPERIORITY||Least square mean difference|-4.33||||0.526||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 10||||0.526
70944926|NCT01917006|141390477|SUPERIORITY||Least square mean difference|-14.76||||0.584||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 12||||0.584
71085565|NCT00676403|141676643|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.6|STANDARD_ERROR_OF_MEAN|2.9||0.0169||95.0|1.3|15.9|||Regression, Logistic|||Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||15.9|1.3|0.0169
71085566|NCT00676403|141676643|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|0.74||0.9569||95.0|0.2|4.3|||Regression, Logistic|||Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||4.3|0.2|0.9569
71085567|NCT00676403|141676643|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.2|STANDARD_ERROR_OF_MEAN|2.07||0.0711||95.0|0.9|11.4|||Regression, Logistic|||Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means.Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||11.4|0.9|0.0711
71085568|NCT00676403|141676643|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.8|STANDARD_ERROR_OF_MEAN|1.85||0.1073||95.0|0.8|10.2|||Regression, Logistic|||Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||10.2|0.8|0.1073
71123441|NCT02008357|141752412|SUPERIORITY||LS Mean difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.0388||0.161|TWO_SIDED|95.0|-0.131|0.022|||ANCOVA|||Total hippocampal volume||0.022|-0.131|0.161
71123442|NCT02008357|141752412|SUPERIORITY||LS Mean difference (Final Values)|0.351|STANDARD_ERROR_OF_MEAN|0.4513||0.437|TWO_SIDED|95.0|-0.535|1.236|||ANCOVA|||Total Lateral Ventricular Volume||1.236|-0.535|0.437
70856625|NCT00711516|141199824|SUPERIORITY_OR_OTHER||Median Difference (Net)|-82.8||||0.5284|TWO_SIDED|95.0|-788.0|165.5|||Wilcoxon (Mann-Whitney)|||||165.5|-788.0|0.5284
70944927|NCT01917006|141390477|SUPERIORITY||Least square mean difference|84.09||||0.101||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 12||||0.101
70944928|NCT01917006|141390477|SUPERIORITY||Least square mean difference|-55.14||||0.823||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 12||||0.823
70944929|NCT01917006|141390477|SUPERIORITY||Least square mean difference|-40.18||||0.741||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 12||||0.741
71123443|NCT00966719|141752429|OTHER||Risk Ratio (RR)|0.84||||0.4|TWO_SIDED|95.0|0.56|1.24|||Fisher Exact|||||1.24|0.56|0.40
71123444|NCT00966719|141752430|OTHER||Risk Ratio (RR)|1.15||||1|TWO_SIDED|95.0|0.44|3.02|||Fisher Exact|||||3.02|0.44|1
71123445|NCT00966719|141752431|OTHER||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|0.91|1.1|||Fisher Exact|||||1.10|0.91|1
71123446|NCT00966719|141752432|OTHER||Risk Ratio (RR)|1.03||||0.78|TWO_SIDED|95.0|0.85|1.26|||Fisher Exact|||||1.26|0.85|0.78
71123447|NCT00966719|141752433|OTHER||Risk Ratio (RR)|2.94||||0.32|TWO_SIDED|95.0|0.32|27.3|||Fisher Exact|||||27.30|0.32|0.32
71123448|NCT00966719|141752434|OTHER||Risk Ratio (RR)|1.5||||0.09|TWO_SIDED|95.0|0.95|2.38|||Fisher Exact|||||2.38|0.95|0.09
71123449|NCT00966719|141752435|OTHER||Risk Ratio (RR)|1.03||||0.77|TWO_SIDED|95.0|0.83|1.27|||Fisher Exact|||||1.27|0.83|0.77
71123450|NCT00966719|141752436|OTHER||Risk Ratio (RR)|1.36||||0.6|TWO_SIDED|95.0|0.58|3.15|||Fisher Exact|||||3.15|0.58|0.6
71123451|NCT01688921|141752463|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was defined as the upper bound of the two-sided 95% CI of the GMT ratio (GMT with NS / GMT with PJ Stratis) for each antigen did not exceed 1.5 fold.|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.88|1.12||||||For a sample size of 550 per group each test has an individual power of \> 99% to rule out the 1.5-fold difference using a two-sided α = 0.05, assuming equal GMTs between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is \> 80%, computed as product of 6 individual powers.||1.12|0.88|
71123452|NCT01688921|141752464|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was defined as the upper bound of the two-sided 95% CI of the GMT ratio (GMT with NS / GMT with PJ Stratis) for each antigen did not exceed 1.5 fold.|Geometric Mean Ratio|1.08|||||TWO_SIDED|95.0|0.96|1.21||||||For a sample size of 550 per group each test has an individual power of \> 99% to rule out the 1.5-fold difference using a two-sided α = 0.05, assuming equal GMTs between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is \> 80%, computed as product of 6 individual powers.||1.21|0.96|
71123453|NCT01688921|141752465|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was defined as the upper bound of the two-sided 95% CI of the GMT ratio (GMT with NS / GMT with PJ Stratis) for each antigen did not exceed 1.5 fold.|Geometric Mean Ratio|0.94|||||TWO_SIDED|95.0|0.83|1.06||||||For a sample size of 550 per group each test has an individual power of \> 99% to rule out the 1.5-fold difference using a two-sided α = 0.05, assuming equal GMTs between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is \> 80%, computed as product of 6 individual powers.||1.06|0.83|
70944930|NCT01917006|141390477|SUPERIORITY||Least square mean difference|-41.31||||0.756||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 12||||0.756
70944931|NCT01917006|141390477|SUPERIORITY||Least square mean difference|-2.57||||0.517||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 12||||0.517
71123454|NCT01688921|141752466|NON_INFERIORITY_OR_EQUIVALENCE|Seroconversion rate defined as the proportion of subjects with either a pre-vaccination titer of \<10 achieving a post-vaccination antibody of HI titer of ≥ 40 or with a pre-vaccination HI titer of ≥ 10 achieving a four-fold or greater increase in post-vaccination HI titer. The non-inferiority margin was defined as the upper bound of the two-sided 95% CI on the difference between the seroconversion rates (rate with NS - with PJ Stratis) for each vaccine strain did not exceed 10 percentage points.|Seroconversion Rate Difference|0.8|||||TWO_SIDED|95.0|-4.8|6.5||||||For a sample size of 550 per group each test has an individual power of \> 95% to rule out the 10 percentage points difference using a one-sided α = 0.025, assuming equal seroconversion rates between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is \> 80%, computed as product of 6 individual powers.||6.5|-4.8|
71123455|NCT01688921|141752467|NON_INFERIORITY_OR_EQUIVALENCE|Seroconversion rate defined as the proportion of subjects with either a pre-vaccination titer of \<10 achieving a post-vaccination antibody of HI titer of ≥ 40 or with a pre-vaccination HI titer of ≥ 10 achieving a four-fold or greater increase in post-vaccination HI titer. The non-inferiority margin was defined as the upper bound of the two-sided 95% CI on the difference between the seroconversion rates(rate with NS - with PJ Stratis) for each vaccine strain did not exceed 10 percentage points|Seroconversion Rate Difference|1.3|||||TWO_SIDED|95.0|-4.5|7.1||||||For a sample size of 550 per group each test has an individual power of \> 95% to rule out the 10 percentage points difference using a one-sided α = 0.025, assuming equal seroconversion rates between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is \> 80%, computed as product of 6 individual powers.||7.1|-4.5|
71123456|NCT01688921|141752468|NON_INFERIORITY_OR_EQUIVALENCE|"Seroconversion rate was defined as the proportion of subjects with either a pre-vaccination titer of \<10 achieving a post-vaccination antibody of HI titer of ≥ 40 or with a pre-vaccination HI titer of ≥ 10 achieving a four-fold or greater increase in post-vaccination HI titer.~The upper-bound of the two-sided 95% CI on the difference in seroconversion rates for the A/H1N1, A/H3N2, and B strains did not exceed 10 percentage points (6.5, 7.1, and 5.9 respectively)."|Seroconversion Rate Difference|0.3|||||TWO_SIDED|95.0|-5.2|5.9||||||For a sample size of 550 per group each test has an individual power of \> 91% to rule out the 10 percentage points difference using a one-sided α = 0.025, assuming equal seroconversion rates between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is \> 80%, computed as product of 6 individual powers.||5.9|-5.2|
71123457|NCT01688921|141752469|NON_INFERIORITY_OR_EQUIVALENCE|Immediate adverse events were reported within 30 minutes of receiving the vaccination; therefore, they are all considered related to study treatment.|||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
71123458|NCT01688921|141752470|NON_INFERIORITY_OR_EQUIVALENCE|The safety population included subjects who received the vaccination and for whom follow-up data were available for a specific safety analysis. Therefore, the denominators for different safety tables vary, depending on the availability of the data.|||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
71123459|NCT01636713|141752503|SUPERIORITY_OR_OTHER||Least squares mean difference|0.151|||<|0.001|TWO_SIDED|95.0|0.11|0.191|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus Placebo.|||0.191|0.110|<0.001
71123460|NCT01636713|141752503|SUPERIORITY_OR_OTHER||Least squares mean difference|0.216|||<|0.001|TWO_SIDED|95.0|0.175|0.257|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference= UMEC/VI 125/25 µg minus Placebo.|||0.257|0.175|<0.001
71123461|NCT03780959|141752506|SUPERIORITY|||||||0.003|||||||Mantel Haenszel|Stratified by study center and the number of active joints at randomization||||||0.0030
71123462|NCT03780959|141752507|SUPERIORITY|||||||0.0001|||||||Log Rank|||||||0.0001
71123463|NCT03921554|141752536|SUPERIORITY||Estimated change (52 weeks - baseline)|0.9|||<|0.0005|TWO_SIDED|95.0|0.5|1.2||The a priori threshold for statistical significance was \< 0.05.|Wald test||We fit a GEE model with AGS score as outcome and an indicator variable for 52 weeks. An exchangeable correlation structure was used to model intra-participant association of AGS scores. The model allowed for up to 2 measurements per participant.|"We are testing the null hypothesis is that the change from baseline (52 weeks - baseline) in AGS is zero.~45 participants had 2 measurements (at baseline and 52 weeks); 6 participants had 1 measurement (at baseline). All participants were included in the analysis."||1.2|0.5|<0.0005
71123464|NCT03921554|141752537|SUPERIORITY||Estimated change (Day 673 - Day 0)|1.09|||<|0.0005|TWO_SIDED|95.0|0.57|1.62||The a priori threshold for statistical significance was \<0.05.|Wald test||We fit a GEE model of AGS on day of treatment (modeled with cubic splines with knots at days 0, 84, 168, 336, 506, 673, and 1006). Goodness of fit criteria were used to select GEE model with AR(1) correlation structure.|We estimate change from Day 0 to Day 673 of treatment (Day 673 minus Day 0) with 95% confidence interval (CI). All participants are included in the analysis.||1.62|0.57|<0.0005
71123465|NCT03921554|141752538|SUPERIORITY||Estimated change (52 weeks - baseline)|2.2||||0.295|TWO_SIDED|95.0|-1.9|6.4||The a priori threshold for statistical significance was \<0.05.|Wald test||We fit a GEE model with GMFM-88 as outcome, with indicator variables for 52 weeks (vs. baseline) and cohorts B and C (vs. A); in addition, time by cohort interaction terms are included. The model allow for up to 2 measurements per participant.|"We are testing the null hypothesis that the change from baseline (52 weeks - baseline) in GMFM-88 is zero within cohorts.~35 participants had 2 measurements (at baseline and 52 weeks); 15 participants had 1 measurement (at baseline). All participants are included in the analysis."||6.4|-1.9|0.295
71123466|NCT03921554|141752538|SUPERIORITY||Estimated change (52 weeks - baseline)|7.0||||0.007|TWO_SIDED|95.0|1.9|12.0||The a priori threshold for statistical significance was \<0.05.|Wald test||We fit a GEE model with GMFM-88 as outcome, with indicator variables for 52 weeks (vs. baseline) and cohorts B and C (vs. A); in addition, time by cohort interaction terms are included. The model allow for up to 2 measurements per participant.|"We are testing the null hypothesis that the change from baseline (52 weeks - baseline) in GMFM-88 is zero within cohorts.~35 participants had 2 measurements (at baseline and 52 weeks); 15 participants had 1 measurement (at baseline). All participants are included in the analysis."||12.0|1.9|0.007
71123467|NCT03921554|141752538|SUPERIORITY||Estimated change (52 weeks - baseline)|0.26||||0.932|TWO_SIDED|95.0|-5.7|6.2||The a priori threshold for statistical significance was \<0.05.|Wald test||We fit a GEE model with GMFM-88 as outcome, with indicator variables for 52 weeks (vs. baseline) and cohorts B and C (vs. A); in addition, time by cohort interaction terms are included. The model allow for up to 2 measurements per participant.|"We are testing the null hypothesis that the change from baseline (52 weeks - baseline) in GMFM-88 is zero within cohorts.~35 participants had 2 measurements (at baseline and 52 weeks); 15 participants had 1 measurement (at baseline). All participants are included in the analysis."||6.2|-5.7|0.932
71123468|NCT03921554|141752539|SUPERIORITY||Estimated change (Day 3 - Day 0)|-8.76|||<|0.0005|TWO_SIDED|95.0|-11.7|-5.81||The a priori threshold for statistical significance was \<0.05.|Wald test||We fit a QLS model of ISG on day of treatment and indicator variable for post-treatment. Goodness of fit criteria were used to select QLS model with exchangeable correlation structure.|We estimate change from pre to post treatment (Day 3 minus Day 0) with 95% confidence interval (CI). All participants are included in the analysis.||-5.81|-11.7|<0.0005
71123469|NCT03921554|141752540|SUPERIORITY||Estimated change (day 335 minus day 0)|-0.11||||0.002|TWO_SIDED|95.0|-0.18|-0.04||The a priori threshold for statistical significance was \<0.05.|Wald test||We fit a GEE model of diary average score on day of treatment and indicator variable for post-treatment. Goodness of fit criteria were used to select GEE model with exchangeable correlation structure.|We estimate change from Day 0 to Day 335 (Day 335 - Day 0) with 95% confidence interval (CI). All participants are included in the analysis.||-0.04|-0.18|0.002
71123470|NCT01299571|141752555|SUPERIORITY_OR_OTHER||Percentage of participants|3.8||||||95.0|3.2|4.4|||||The estimated value represents the percentage of participants with adverse events.|||4.4|3.2|
70856626|NCT00711516|141199825|SUPERIORITY_OR_OTHER||Median Difference (Net)|-145.8||||0.8997|TWO_SIDED|95.0|-3151.0|1006.5|||Wilcoxon (Mann-Whitney)|||||1006.5|-3151.0|0.8997
70856627|NCT00711516|141199826|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-25.1||||0.1305|TWO_SIDED|95.0|-58.2|8.0|||ANCOVA|||||8.0|-58.2|0.1305
70856628|NCT01029405|141199836|SUPERIORITY_OR_OTHER||||||<|0.001|||||||2-sided sign test|||||||<0.001
71085569|NCT00676403|141676643|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.4|STANDARD_ERROR_OF_MEAN|1.48||0.1583||95.0|0.7|8.1|||Regression, Logistic|||Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||8.1|0.7|0.1583
71085570|NCT00676403|141676643|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.1|STANDARD_ERROR_OF_MEAN|2.8||0.0385||95.0|1.1|15.6|||Regression, Logistic|||Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||15.6|1.1|0.0385
71085571|NCT00676403|141676643|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.6|STANDARD_ERROR_OF_MEAN|1.09||0.4923||95.0|0.4|6.1|||Regression, Logistic|||Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||6.1|0.4|0.4923
70856629|NCT02108262|141199852|NON_INFERIORITY|The calculation used a non-inferiority argument powering the test of the alternative hypothesis of no difference in the rates. Within each co-primary endpoint, the two active treatment groups are assumed to have the same endpoint rates. Total alpha is 0.05 with 0.025 allocated to each co-primary endpoint, which in turn involves comparisons of two active treatment groups to placebo without further alpha control.|Difference in event rates (%)|1.0|||=|0.1241|TWO_SIDED|95.0|-0.1|2.5|||Newcombe-Wilson score method|||||2.5|-0.1|= 0.1241
71085572|NCT00676403|141676643|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.3|STANDARD_ERROR_OF_MEAN|0.8||0.7169||95.0|0.4|4.4|||Regression, Logistic|||Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||4.4|0.4|0.7169
71085573|NCT00676403|141676643|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.7|STANDARD_ERROR_OF_MEAN|1.12||0.4156||95.0|0.5|6.2|||Regression, Logistic|||Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||6.2|0.5|0.4156
71085574|NCT00676403|141676643|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.7|STANDARD_ERROR_OF_MEAN|1.04||0.4165||95.0|0.5|5.6|||Regression, Logistic|||Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||5.6|0.5|0.4165
71123471|NCT01842581|141752568|NON_INFERIORITY|Threshold for significance=upper bound of the 2-sided 95% confidence interval (CI) for hazard ratio less than (\<) 1.56.|Hazard Ratio (HR)|1.959||||0.0359|TWO_SIDED|95.0|1.045|3.672|||Score statistics|||Hazard ratio estimate (hazard of breakthrough HE for rifaximin compared to rifaximin + lactulose) obtained from Cox proportional hazards model with effect for treatment, stratified by analysis region.||3.672|1.045|0.0359
71123472|NCT01842581|141752569|SUPERIORITY|2-sided test at a significance level of 0.05.|Hazard Ratio (HR)|1.739||||0.0985|TWO_SIDED|95.0|0.894|3.382||Threshold for significance at 0.05 level.|Log Rank|||Analysis was performed using log-rank test stratified by analysis region. Hazard ratio estimate (hazard of breakthrough HE for rifaximin compared to rifaximin + lactulose) obtained from Cox proportional hazards model with effect for treatment, stratified by analysis region.||3.382|0.894|0.0985
71123473|NCT00530920|141752620|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.43||||0.997|||||||Wilcoxon (Mann-Whitney)|||NULL HYPOTHESIS (H0): Median viral load reduction from baseline \>1.2 log10 copies/mL within each group||||0.997
71123474|NCT00530920|141752620|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.55||||1|||||||Wilcoxon (Mann-Whitney)|||NULL HYPOTHESIS (H0): Median viral load reduction from baseline \>1.2 log10 copies/mL within each group||||1
71123475|NCT00530920|141752620|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.47||||0.998|||||||Wilcoxon (Mann-Whitney)|||NULL HYPOTHESIS (H0): Median viral load reduction from baseline \>1.2 log10 copies/mL within each group||||0.998
71123476|NCT00707746|141752641|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤ 0.05.|t-test, 2 sided|||It was estimated that the standard deviation of the percent change in LDL-C was 20%. A sample size of 30 patients was planned for this study: 20 patients in the mipomersen group and 10 patients in the placebo group. A 2-sided t-test with an alpha level of 0.05 was expected to provide ≥90% power to detect a 30% difference in LDL-C percent reduction between the 2 groups (35% reduction for the mipomersen group and 5% reduction for the placebo group).||||<0.001
71123477|NCT00707746|141752644|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|Wilcoxon signed rank sum|||||||<0.001
71123478|NCT00707746|141752646|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
70944932|NCT01917006|141390478|SUPERIORITY||Least square mean difference|0.59||||0.079||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 2||||0.079
71123479|NCT00707746|141752648|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
71123480|NCT00707746|141752650|SUPERIORITY_OR_OTHER|||||||0.005||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.005
71085575|NCT00676403|141676643|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.6|STANDARD_ERROR_OF_MEAN|1.08||0.4673||95.0|0.4|6.0|||Regression, Logistic|||Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||6.0|0.4|0.4673
71085576|NCT00676403|141676643|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|0.72||0.9855||95.0|0.2|4.1|||Regression, Logistic|||Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||4.1|0.2|0.9855
71085577|NCT00676403|141676643|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|0.61||0.9566||95.0|0.3|3.3|||Regression, Logistic|||Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||3.3|0.3|0.9566
71085578|NCT00676403|141676643|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.7|STANDARD_ERROR_OF_MEAN|1.17||0.4632||95.0|0.4|6.6|||Regression, Logistic|||Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||6.6|0.4|0.4632
71085579|NCT00676403|141676643|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.4|STANDARD_ERROR_OF_MEAN|0.29||0.2042||95.0|0.1|1.6|||Regression, Logistic|||Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||1.6|0.1|0.2042
70856630|NCT02108262|141199852|NON_INFERIORITY|The calculation used a non-inferiority argument powering the test of the alternative hypothesis of no difference in the rates. Within each co-primary endpoint, the two active treatment groups are assumed to have the same endpoint rates. Total alpha is 0.05 with 0.025 allocated to each co-primary endpoint, which in turn involves comparisons of two active treatment groups to placebo without further alpha control.|Difference in event rates (%)|0.5|||=|0.4994|TWO_SIDED|95.0|-0.5|1.7|||Newcombe-Wilson score method|||||1.7|-0.5|= 0.4994
70856631|NCT02108262|141199853|NON_INFERIORITY|The calculation used a non-inferiority argument powering the test of the alternative hypothesis of no difference in the rates. Within each co-primary endpoint, the two active treatment groups are assumed to have the same endpoint rates. Total alpha is 0.05 with 0.025 allocated to each co-primary endpoint, which in turn involves comparisons of two active treatment groups to placebo without further alpha control.|Difference in event rates (%)|-0.2|||=|0.4988|TWO_SIDED|95.0|-1.4|0.7|||Newcombe-Wilson score method|||||0.7|-1.4|= 0.4988
71085580|NCT00676403|141676643|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9|STANDARD_ERROR_OF_MEAN|1.34||0.3382||95.0|0.5|7.5|||Regression, Logistic|||Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||7.5|0.5|0.3382
71123481|NCT00707746|141752652|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided|||||||<0.001
71123482|NCT00707746|141752654|SUPERIORITY_OR_OTHER|||||||0.006||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.006
71123483|NCT00707746|141752656|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided|||||||<0.001
71123484|NCT00707746|141752658|SUPERIORITY_OR_OTHER|||||||0.784||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.784
71123485|NCT00707746|141752660|SUPERIORITY_OR_OTHER|||||||0.079||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.079
71123486|NCT00973102|141752722|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.47||||0.252|TWO_SIDED|95.0|1.16|5.25|||Barnard's unconditional Exact Test|||||5.25|1.16|.252
71123487|NCT00973102|141752723|SUPERIORITY_OR_OTHER_LEGACY|||||||0.895|||||||t-test, 2 sided|||||||.895
71123488|NCT00853840|141752724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||||90.0|-3.8|1.59|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"1.5 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||1.59|-3.80|
71123489|NCT00853840|141752724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93||||||90.0|-3.55|-0.31|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"1.5 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.31|-3.55|
71123490|NCT00853840|141752724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.99||||||90.0|-7.69|-2.3|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-2.30|-7.69|
71085581|NCT00676403|141676644|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.6||||0.3932||95.0|-6.0|15.2|||ANCOVA|||Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.||15.2|-6.0|0.3932
71085582|NCT00676403|141676644|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.3||||0.1585||95.0|-2.9|17.5|||ANCOVA|||Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.||17.5|-2.9|0.1585
71085583|NCT00676403|141676644|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.8||||0.285||95.0|-4.9|16.5|||ANCOVA|||Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.||16.5|-4.9|0.2850
71085584|NCT00676403|141676644|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.8645||95.0|-9.4|11.1|||ANCOVA|||Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.||11.1|-9.4|0.8645
71085585|NCT00676403|141676644|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.4||||0.3031||95.0|-5.0|15.8|||ANCOVA|||Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.||15.8|-5.0|0.3031
71085586|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1||||0.5384||95.0|-13.2|7.0|||ANCOVA|||Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||7.0|-13.2|0.5384
71123491|NCT00853840|141752724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.96||||||90.0|-4.58|-1.34|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-1.34|-4.58|
71123492|NCT00853840|141752724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.88||||||90.0|-7.58|-2.19|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2.5 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-2.19|-7.58|
70856632|NCT02108262|141199853|NON_INFERIORITY|The calculation used a non-inferiority argument powering the test of the alternative hypothesis of no difference in the rates. Within each co-primary endpoint, the two active treatment groups are assumed to have the same endpoint rates. Total alpha is 0.05 with 0.025 allocated to each co-primary endpoint, which in turn involves comparisons of two active treatment groups to placebo without further alpha control.|Difference in event rates (%)|0.5|||=|0.6241|TWO_SIDED|95.0|-0.7|1.9|||Newcombe-Wilson score method|||||1.9|-0.7|= 0.6241
70856633|NCT02108262|141199854|OTHER||Hazard Ratio (HR)|1.18|||=|0.5733|TWO_SIDED|95.0|0.67|2.05||Stratified log-rank p-value|Log Rank|||||2.05|0.67|= 0.5733
71085587|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.8015||95.0|-10.9|8.5|||ANCOVA|||Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||8.5|-10.9|0.8015
71085588|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1||||0.4429||95.0|-14.5|6.4|||ANCOVA|||Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||6.4|-14.5|0.4429
71085589|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.886||95.0|-10.5|9.1|||ANCOVA|||Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||9.1|-10.5|0.8860
71085590|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9963||95.0|-10.0|9.9|||ANCOVA|||Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||9.9|-10.0|0.9963
71085591|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.9||||0.3421||95.0|-6.3|18.1|||ANCOVA|||Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||18.1|-6.3|0.3421
71123493|NCT00853840|141752724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.82||||||90.0|-5.44|-2.2|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2.5 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-2.20|-5.44|
70944933|NCT01917006|141390478|SUPERIORITY||Least square mean difference|0.77||||0.025||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 2||||0.025
71085592|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.4||||0.2849||95.0|-5.4|18.1|||ANCOVA|||Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||18.1|-5.4|0.2849
71085593|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.6||||0.3058||95.0|-6.1|19.2|||ANCOVA|||Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||19.2|-6.1|0.3058
71085594|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.9604||95.0|-12.1|11.5|||ANCOVA|||Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||11.5|-12.1|0.9604
71085595|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.5||||0.1661||95.0|-3.6|20.6|||ANCOVA|||Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||20.6|-3.6|0.1661
71085596|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.9||||0.1441||95.0|-3.1|20.9|||ANCOVA|||Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||20.9|-3.1|0.1441
71123494|NCT00853840|141752724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05||||||90.0|-4.74|0.64|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"3 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.64|-4.74|
71085597|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.0||||0.3076||95.0|-5.6|17.5|||ANCOVA|||Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||17.5|-5.6|0.3076
71123495|NCT00853840|141752724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.76||||||90.0|-3.38|-0.15|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"3 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.15|-3.38|
71085598|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.0||||0.1209||95.0|-2.7|22.7|||ANCOVA|||Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||22.7|-2.7|0.1209
71085599|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.4||||0.2791||95.0|-5.3|18.0|||ANCOVA|||Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||18.0|-5.3|0.2791
70856634|NCT02108262|141199854|OTHER||Hazard Ratio (HR)|1.02|||=|0.9717|TWO_SIDED|95.0|0.57|1.8||Stratified log-rank p-value|Log Rank|||||1.80|0.57|= 0.9717
71085600|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.2||||0.0644||95.0|-0.7|23.0|||ANCOVA|||Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||23.0|-0.7|0.0644
71085601|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3||||0.7544||95.0|-9.5|6.9|||ANCOVA|||General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||6.9|-9.5|0.7544
71085602|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.6||||0.5142||95.0|-10.3|5.2|||ANCOVA|||General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||5.2|-10.3|0.5142
71085603|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.8158||95.0|-7.4|9.4|||ANCOVA|||General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||9.4|-7.4|0.8158
71085604|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.9||||0.4599||95.0|-10.8|4.9|||ANCOVA|||General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||4.9|-10.8|0.4599
71085605|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.8636||95.0|-8.7|7.3|||ANCOVA|||General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||7.3|-8.7|0.8636
70856635|NCT01860846|141199918|SUPERIORITY_OR_OTHER||||||=|0.004||||||Baseline vs. 12 months|Wilcoxon signed-ranked test|||The null hypothesis was set as no difference.||||=0.004
70856636|NCT01860846|141199919|SUPERIORITY_OR_OTHER||||||=|0.022||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||The null hypothesis was set as no difference.||||= 0.022
71085606|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.7||||0.5281||95.0|-7.8|15.1|||ANCOVA|||Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||15.1|-7.8|0.5281
71085607|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5||||0.6566||95.0|-8.5|13.5|||ANCOVA|||Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||13.5|-8.5|0.6566
71085608|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.1||||0.0677||95.0|-0.8|23.0|||ANCOVA|||Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||23.0|-0.8|0.0677
71085609|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.3||||0.4443||95.0|-6.8|15.4|||ANCOVA|||Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||15.4|-6.8|0.4443
71085610|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.5||||0.2543||95.0|-4.7|17.7|||ANCOVA|||Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||17.7|-4.7|0.2543
71085611|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.9416||95.0|-11.0|11.9|||ANCOVA|||Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||11.9|-11.0|0.9416
71085612|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1||||0.5824||95.0|-14.1|7.9|||ANCOVA|||Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||7.9|-14.1|0.5824
71085613|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4||||0.5668||95.0|-15.3|8.4|||ANCOVA|||Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||8.4|-15.3|0.5668
71085614|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6||||0.7769||95.0|-9.6|12.8|||ANCOVA|||Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||12.8|-9.6|0.7769
71085615|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.8||||0.1753||95.0|-3.5|19.1|||ANCOVA|||Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||19.1|-3.5|0.1753
71085616|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.7||||0.1508||95.0|-3.2|20.7|||ANCOVA|||Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||20.7|-3.2|0.1508
71085617|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.9||||0.0916||95.0|-1.6|21.4|||ANCOVA|||Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||21.4|-1.6|0.0916
71085618|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.1||||0.6222||95.0|-9.2|15.4|||ANCOVA|||Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||15.4|-9.2|0.6222
71085619|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.2||||0.085||95.0|-1.4|21.8|||ANCOVA|||Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||21.8|-1.4|0.0850
71085620|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.8||||0.0154||95.0|2.9|26.7|||ANCOVA|||Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||26.7|2.9|0.0154
71085621|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8||||0.7201||95.0|-11.9|8.2|||ANCOVA|||Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||8.2|-11.9|0.7201
71123496|NCT00853840|141752724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.08||||||90.0|-4.77|0.62|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"4 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.62|-4.77|
70856637|NCT01860846|141199920|SUPERIORITY_OR_OTHER||||||=|0.006||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||The null hypothesis was set as no difference.||||= 0.006
70856638|NCT01860846|141199921|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||The null hypothesis was set as no difference.||||< 0.001
70856639|NCT01860846|141199922|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Physical Functioning Scores: the null hypothesis was set as no difference.||||< 0.001
70856640|NCT01860846|141199922|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Role-Physical Scores: the null hypothesis was set as no difference.||||< 0.001
70856641|NCT01860846|141199922|SUPERIORITY_OR_OTHER||||||=|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Role-Emotional Scores: the null hypothesis was set as no difference.||||= 0.001
70856642|NCT01860846|141199922|SUPERIORITY_OR_OTHER||||||=|0.019||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Vitality Scores: the null hypothesis was set as no difference.||||= 0.019
70856643|NCT01860846|141199922|SUPERIORITY_OR_OTHER||||||=|0.017||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Mental Health Scores: the null hypothesis was set as no difference.||||= 0.017
70856644|NCT01860846|141199922|SUPERIORITY_OR_OTHER||||||=|0.007||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Social Functioning Scores: the null hypothesis was set as no difference.||||= 0.007
70856645|NCT01860846|141199922|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Bodily Pain Scores: the null hypothesis was set as no difference.||||< 0.001
70856646|NCT01860846|141199922|SUPERIORITY_OR_OTHER||||||=|0.005||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||General Health Scores: the null hypothesis was set as no difference.||||= 0.005
71085622|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7||||0.8875||95.0|-9.1|10.5|||ANCOVA|||Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||10.5|-9.1|0.8875
71085623|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.7||||0.3735||95.0|-5.7|15.1|||ANCOVA|||Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||15.1|-5.7|0.3735
70856647|NCT01860846|141199923|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Bowel-related Symptoms Scores: The null hypothesis was set as no difference.||||< 0.001
70856648|NCT01860846|141199923|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Systemic Symptoms Scores:The null hypothesis was set as no difference.||||< 0.001
70856649|NCT01860846|141199923|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Emotional Function Scores: the null hypothesis was set as no difference.||||< 0.001
70856650|NCT01860846|141199923|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Social Function Scores: The null hypothesis was set as no difference.||||< 0.001
70856651|NCT01856764|141199926|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.496||0.276|TWO_SIDED|95.0|-1.5542|0.4574||Mixed Model Repeated Measures (MMRM) Model: SCORAD change from baseline = treatment + visit + treatment by visit interaction + baseline SCORAD score|Mixed Models Analysis|||||0.4574|-1.5542|0.276
70856652|NCT01856764|141199927|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.91|STANDARD_ERROR_OF_MEAN|3.454||0.095|TWO_SIDED|95.0|-12.9134|1.0835||MMRM model: TEWL change from baseline = treatment + visit + treatment by visit interaction + baseline TEWL score|Mixed Models Analysis|||||1.0835|-12.9134|0.095
70856653|NCT01856764|141199928|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.56|STANDARD_ERROR_OF_MEAN|0.596||0.013|TWO_SIDED|95.0|-2.7656|-0.3492||MMRM model: Assessment of Pruritus change from baseline = treatment + visit + treatment by visit interaction + baseline Assessment of Pruritus score|Mixed Models Analysis|||||-0.3492|-2.7656|0.013
70856654|NCT00420641|141199959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.485|TWO_SIDED|90.0|-2.6|1.05|||Mixed Model Repeated Measures (MMRM)||The point estimate was calculated as least square (LS) mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in MADRS total score at Week 10.||1.05|-2.60|0.485
70856655|NCT00420641|141199959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.99||||0|TWO_SIDED|90.0|-5.75|-2.22|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in MADRS total score at Week 10.||-2.22|-5.75|0.000
70856656|NCT00420641|141199960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.252|TWO_SIDED|90.0|-1.28|0.23|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in Bech score at Week 10.||0.23|-1.28|0.252
70856657|NCT00420641|141199960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.77||||0|TWO_SIDED|90.0|-2.49|-1.05|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in MADRS total score at Week 10.||-1.05|-2.49|0.000
70856658|NCT00420641|141199961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.66||||0.279|TWO_SIDED|90.0|-4.19|0.87|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in IDS-CR total score at Week 10.||0.87|-4.19|0.279
70856659|NCT00420641|141199961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.12||||0.001|TWO_SIDED|90.0|-7.55|-2.68|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in IDS-CR total score at Week 10.||-2.68|-7.55|0.001
70856660|NCT00420641|141199962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05||||0.287|TWO_SIDED|90.0|-5.23|1.12|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in IDS-SR total score at Week 10.||1.12|-5.23|0.287
70856661|NCT00420641|141199962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.23||||0.001|TWO_SIDED|90.0|-9.21|-3.25|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in IDS-SR total score at Week 10.||-3.25|-9.21|0.001
71085624|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.8621||95.0|-8.9|10.6|||ANCOVA|||Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||10.6|-8.9|0.8621
71123497|NCT00853840|141752724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88||||||90.0|-2.49|0.74|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"4 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.74|-2.49|
71123498|NCT00853840|141752724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||||90.0|-4.99|0.39|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"6 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.39|-4.99|
71123499|NCT00853840|141752724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||||90.0|-2.47|0.77|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"6 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.77|-2.47|
71123500|NCT00853840|141752724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.22||||||90.0|-6.91|-1.52|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"8 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-1.52|-6.91|
71123501|NCT00853840|141752724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.51||||||90.0|-4.13|-0.9|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"8 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.90|-4.13|
71123502|NCT00853840|141752724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.94||||||90.0|-4.63|0.76|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"12 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.76|-4.63|
71123503|NCT00853840|141752724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.32||||||90.0|-3.94|-0.7|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"12 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.70|-3.94|
71123504|NCT00853840|141752724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.36||||||90.0|-8.22|-0.5|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"1.5 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.50|-8.22|
71123505|NCT00853840|141752724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.93||||||90.0|-6.29|-1.56|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"1.5 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-1.56|-6.29|
71123506|NCT00853840|141752724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.91||||||90.0|-10.77|-3.05|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-3.05|-10.77|
70944934|NCT01917006|141390478|SUPERIORITY||Least square mean difference|0.07||||0.417||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 2||||0.417
70856662|NCT00420641|141199963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.352|TWO_SIDED|90.0|-1.47|0.41|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in QIDS-CR16 total score at Week 10.||0.41|-1.47|0.352
70856663|NCT00420641|141199963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71||||0.002|TWO_SIDED|90.0|-2.62|-0.81|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in QIDS-CR16 total score at Week 10.||-0.81|-2.62|0.002
70856664|NCT00420641|141199964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.168|TWO_SIDED|90.0|-2.27|0.2|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in QIDS-SR16 total score at Week 10.||0.20|-2.27|0.168
70856665|NCT00420641|141199964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.12||||0.002|TWO_SIDED|90.0|-3.27|-0.97|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in QIDS-SR16 total score at Week 10.||-0.97|-3.27|0.002
70856666|NCT00420641|141199965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.257|TWO_SIDED|90.0|-0.46|0.09|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in MADRS Item 2 score at Week 10.||0.09|-0.46|0.257
70856667|NCT00420641|141199965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.001|TWO_SIDED|90.0|-0.77|-0.25|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in MADRS Item 2 score at Week 10.||-0.25|-0.77|0.001
70856668|NCT00420641|141199966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.096|TWO_SIDED|90.0|-0.33|0.0|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in IDS-CR Item 5 score at Week 10.||-0.00|-0.33|0.096
70856669|NCT00420641|141199966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0|TWO_SIDED|90.0|-0.53|-0.22|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in IDS-CR Item 5 at Week 10.||-0.22|-0.53|0.000
70856670|NCT00420641|141199967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.576|TWO_SIDED|90.0|-1.84|0.91|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in HAMD-17 total score at Week 10.||0.91|-1.84|0.576
70856671|NCT00420641|141199967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.96||||0|TWO_SIDED|90.0|-4.28|-1.64|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in HAMD-17 total score at Week 10.||-1.64|-4.28|0.000
70856672|NCT00420641|141199968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.209|TWO_SIDED|90.0|-0.38|0.05|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in HAMD-17 Item 1 score at Week 10.||0.05|-0.38|0.209
70856673|NCT00420641|141199968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.002|TWO_SIDED|90.0|-0.6|-0.19|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in HAMD-17 Item 1 score at Week 10.||-0.19|-0.60|0.002
70856674|NCT00420641|141199969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.175|TWO_SIDED|90.0|-1.23|0.12|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in IDS-CR 5 Item subscale total score at Week 10.||0.12|-1.23|0.175
70856675|NCT00420641|141199969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15||||0.003|TWO_SIDED|90.0|-1.79|-0.5|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in IDS-CR 5 Item subscale total score at Week 10.||-0.50|-1.79|0.003
70856676|NCT00420641|141199969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||0.082|TWO_SIDED|90.0|-1.92|-0.05|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in IDS-SR 5 Item subscale total score at Week 10.||-0.05|-1.92|0.082
70856677|NCT00420641|141199969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.77||||0.001|TWO_SIDED|90.0|-2.64|-0.9|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in IDS-SR 5 Item subscale total score at Week 10.||-0.90|-2.64|0.001
70856678|NCT00420641|141199970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.208|TWO_SIDED|90.0|-0.45|0.06|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in CGI-S score at Week 10.||0.06|-0.45|0.208
70856679|NCT00420641|141199970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0|TWO_SIDED|90.0|-0.76|-0.28|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in CGI-S score at Week 10.||-0.28|-0.76|0.000
70856680|NCT00420641|141199971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.76||||0.516|TWO_SIDED|90.0|-2.71|6.24|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in MEI total score at Week 10.||6.24|-2.71|0.516
70856681|NCT00420641|141199971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.22||||0.016|TWO_SIDED|90.0|1.97|10.48|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in MEI total score at Week 10.||10.48|1.97|0.016
70856682|NCT00420641|141199972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.72||||0.126|TWO_SIDED|90.0|-0.13|3.57|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in CSFQ-14SF total score at Week 10.||3.57|-0.13|0.126
70856683|NCT00420641|141199972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.957|TWO_SIDED|90.0|-1.69|1.81|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in CSFQ-14SF total score at Week 10.||1.81|-1.69|0.957
70856684|NCT00420641|141199976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.5061|TWO_SIDED|90.0|0.21|1.93|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 1.||1.93|0.21|0.5061
70856685|NCT00420641|141199976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.7398|TWO_SIDED|90.0|0.46|3.25|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 1.||3.25|0.46|0.7398
70856686|NCT00420641|141199976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.9209|TWO_SIDED|90.0|0.52|2.08|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 2.||2.08|0.52|0.9209
71085625|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.9||||0.1203||95.0|-2.1|17.8|||ANCOVA|||Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||17.8|-2.1|0.1203
71085626|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.8||||0.4966||95.0|-5.4|11.0|||ANCOVA|||Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||11.0|-5.4|0.4966
71085627|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.2||||0.5776||95.0|-5.6|10.1|||ANCOVA|||Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||10.1|-5.6|0.5776
71085628|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.7||||0.3955||95.0|-4.9|12.3|||ANCOVA|||Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||12.3|-4.9|0.3955
71085629|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.7994||95.0|-6.9|9.0|||ANCOVA|||Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||9.0|-6.9|0.7994
71123507|NCT00853840|141752724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.79||||||90.0|-8.15|-3.42|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-3.42|-8.15|
71085630|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.2||||0.2073||95.0|-2.9|13.2|||ANCOVA|||Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||13.2|-2.9|0.2073
71085631|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.2||||0.5148||95.0|-6.4|12.8|||ANCOVA|||Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||12.8|-6.4|0.5148
71123508|NCT00853840|141752724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.8||||||90.0|-9.66|-1.94|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2.5 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-1.94|-9.66|
71123509|NCT00853840|141752724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.65||||||90.0|-9.01|-4.29|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2.5 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-4.29|-9.01|
71123510|NCT00853840|141752724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.27||||||90.0|-8.13|-0.41|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"3 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.41|-8.13|
70856687|NCT00420641|141199976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.2908|TWO_SIDED|90.0|0.78|3.13|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 2.||3.13|0.78|0.2908
70856688|NCT00420641|141199976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41||||0.0086|TWO_SIDED|90.0|0.23|0.72|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 3.||0.72|0.23|0.0086
70856689|NCT00420641|141199976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.8087|TWO_SIDED|90.0|0.64|1.83|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 3.||1.83|0.64|0.8087
71085632|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.0||||0.5255||95.0|-6.3|12.2|||ANCOVA|||Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||12.2|-6.3|0.5255
71085633|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.4||||0.3793||95.0|-5.5|14.4|||ANCOVA|||Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||14.4|-5.5|0.3793
71123511|NCT00853840|141752724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.65||||||90.0|-6.01|-1.29|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"3 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-1.29|-6.01|
70856690|NCT00420641|141199976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.31||||0.0002|TWO_SIDED|90.0|0.18|0.52|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 4.||0.52|0.18|0.0002
71085634|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.8||||0.312||95.0|-4.5|14.1|||ANCOVA|||Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||14.1|-4.5|0.3120
71085635|NCT00676403|141676645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.7||||0.0442||95.0|0.3|19.2|||ANCOVA|||Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||19.2|0.3|0.0442
71085636|NCT00676403|141676646|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4452||95.0|||||Cochran-Mantel-Haenszel|||CHM test for difference; p-value was adjusted for geographic region at each visit.||||0.4452
71085637|NCT00676403|141676646|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4342||95.0|||||Cochran-Mantel-Haenszel|||CHM test for difference; p-value was adjusted for geographic region at each visit.||||0.4342
71085638|NCT00676403|141676646|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0942||95.0|||||Cochran-Mantel-Haenszel|||CHM test for difference; p-value was adjusted for geographic region at each visit.||||0.0942
71085639|NCT00676403|141676646|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1873||95.0|||||Cochran-Mantel-Haenszel|||CHM test for difference; p-value was adjusted for geographic region at each visit.||||0.1873
71085640|NCT00676403|141676646|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4709||95.0|||||Cochran-Mantel-Haenszel|||CHM test for difference; p-value was adjusted for geographic region at each visit.||||0.4709
71085641|NCT01039467|141676651|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71085642|NCT01039467|141676652|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71085643|NCT01039467|141676653|SUPERIORITY_OR_OTHER_LEGACY|||||||0.833||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.833
71085644|NCT01039467|141676654|SUPERIORITY_OR_OTHER_LEGACY|||||||0.265||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.265
71085645|NCT01039467|141676655|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
71085646|NCT01039467|141676656|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71085647|NCT01039467|141676657|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0008
71085648|NCT01039467|141676658|SUPERIORITY_OR_OTHER_LEGACY|||||||0.053||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.053
71085649|NCT01039467|141676659|SUPERIORITY_OR_OTHER_LEGACY|||||||0.493||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.493
71085650|NCT05209880|141676667|SUPERIORITY|||||||0.5835|||||||Wilcoxon (Mann-Whitney)|||||||0.5835
71085651|NCT04073303|141676677|SUPERIORITY||Rate-Difference|49.0|||<|0.0001|TWO_SIDED|95.0|40.1|54.1|||Cochran-Mantel-Haenszel|||||54.1|40.1|<0.0001
71085652|NCT04073303|141676678|SUPERIORITY||Rate-Difference|71.2|||<|0.0001|TWO_SIDED|95.0|60.7|76.3|||Cochran-Mantel-Haenszel|||||76.3|60.7|<0.0001
71085653|NCT04073303|141676679|SUPERIORITY||Rate-Difference|56.7|||<|0.0001|TWO_SIDED|95.0|45.6|64.5|||Cochran-Mantel-Haenszel|||||64.5|45.6|<0.0001
71085654|NCT04073303|141676680|SUPERIORITY||Rate-Difference|49.7|||<|0.0001|TWO_SIDED|95.0|40.6|57.4|||Cochran-Mantel-Haenszel|||||57.4|40.6|<0.0001
71085655|NCT04073303|141676681|SUPERIORITY||Rate-Difference|70.5|||<|0.0001|TWO_SIDED|95.0|59.6|77.5|||Cochran-Mantel-Haenszel|||||77.5|59.6|<0.0001
71085656|NCT04073303|141676682|SUPERIORITY||LS Mean of Difference|-5.19|||<|0.0001|TWO_SIDED|95.0|-5.64|-4.75|||ANCOVA|||||-4.75|-5.64|<0.0001
71085657|NCT02554760|141676694|OTHER||success proportion|84.2|||||TWO_SIDED|95.0|60.4|92.3|||Catagorical tabulation|||||92.3|60.4|
71085658|NCT02554760|141676694|OTHER||success proportion|78.9|||||TWO_SIDED|95.0|54.4|93.9||||||||93.9|54.4|
71085659|NCT02689804|141676699|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71085660|NCT02689804|141676700|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
71085661|NCT03113968|141676720|NON_INFERIORITY|The Farrington-Manning score test was used to assess the noninferiority of KET.|||||<|0.001|||||||The Farrington-Manning score test|||||||<.001
71085662|NCT03113968|141676721|SUPERIORITY||Mean Difference (Net)|9.3|||||TWO_SIDED||||||||||P-values not reported|||
70856691|NCT00420641|141199976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.4606|TWO_SIDED|90.0|0.78|1.94|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 4.||1.94|0.78|0.4606
70856692|NCT00420641|141199976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.1399|TWO_SIDED|90.0|0.4|1.05|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 5.||1.05|0.40|0.1399
70856693|NCT00420641|141199976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.0461|TWO_SIDED|90.0|1.1|2.73|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 5.||2.73|1.10|0.0461
71085663|NCT04805671|141676722|SUPERIORITY||Risk Difference (RD)|-8.7||||0.0047|TWO_SIDED|95.0|-14.71|-2.67|||Regression, Logistic|||ADG20 vs Placebo|A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|-2.67|-14.71|0.0047
71085664|NCT04805671|141676727|SUPERIORITY||Risk Difference (RD)|-11.3||||0.0007|TWO_SIDED|95.0|-17.86|-4.81|||Regression, Logistic|||ADG20 vs Placebo|A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|-4.81|-17.86|0.0007
71085665|NCT04805671|141676728|SUPERIORITY||Risk Difference (RD)|-8.7||||0.0047|TWO_SIDED|95.0|-14.71|-2.67|||Regression, Logistic|||ADG20 vs Placebo|A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|-2.67|-14.71|0.0047
71085666|NCT04805671|141676729|SUPERIORITY||Risk Difference (RD)|-11.3||||0.0007|TWO_SIDED|95.0|-17.86|-4.81|||Regression, Logistic|||ADG20 vs Placebo|A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|-4.81|-17.86|0.0007
71085667|NCT04805671|141676730|SUPERIORITY||Hazard Ratio (HR)|1.237||||0.0938|TWO_SIDED|95.0|0.964|1.586|||Regression, Cox|||ADG20 vs. Placebo||1.586|0.964|0.0938
71085668|NCT04805671|141676731|SUPERIORITY||Hazard Ratio (HR)|0.137||||0.0361|TWO_SIDED|95.0|0.016|1.162|||Regression, Cox|||ADG20 vs Placebo||1.162|0.016|0.0361
71085669|NCT04805671|141676732|SUPERIORITY||Hazard Ratio (HR)|1.255||||0.0781|TWO_SIDED|95.0|0.974|1.617|||Regression, Cox|||ADG20 vs Placebo||1.617|0.974|0.0781
71085670|NCT04805671|141676733|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.4976|TWO_SIDED|95.0|-0.66|0.32|||ANCOVA|||ADG20 vs. Placebo||0.32|-0.66|0.4976
71085671|NCT04805671|141676734|SUPERIORITY||Hazard Ratio (HR)|1.048||||0.7239|TWO_SIDED|95.0|0.806|1.364|||Regression, Cox|||||1.364|0.806|0.7239
71085672|NCT04805671|141676735|SUPERIORITY||Risk Difference (RD)|-11.1||||0.0364|TWO_SIDED|95.0|-21.42|-0.7|||Regression, Logistic|||||-0.70|-21.42|0.0364
71085673|NCT04805671|141676736|SUPERIORITY||Risk Difference (RD)|8.2||||0.0227|TWO_SIDED|95.0|1.15|15.31||The p-value and risk difference reported was calculated based on the Day 5 timepoint.|Regression, Logistic|||||15.31|1.15|0.0227
71085674|NCT04805671|141676737|SUPERIORITY||Mean Difference (Final Values)|-6.93||||0.1124|TWO_SIDED|95.0|-15.49|1.64|||ANCOVA|||||1.64|-15.49|0.1124
71085675|NCT01387178|141676743|SUPERIORITY_OR_OTHER||Adjusted Mean|7451.0|||||TWO_SIDED|95.0|5857.0|9045.0|||||The mean predicted cost for inpatient services for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||9045|5857|
71085676|NCT01387178|141676743|SUPERIORITY_OR_OTHER||Adjusted Mean|11545.0|||||TWO_SIDED|95.0|8827.0|14263.0|||||The mean predicted cost for inpatient services for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||14263|8827|
71085677|NCT01387178|141676743|SUPERIORITY_OR_OTHER||Adjusted Mean|61.0|||||TWO_SIDED|95.0|58.0|63.0|||||The mean predicted cost for emergency department visits for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||63|58|
71085678|NCT01387178|141676743|SUPERIORITY_OR_OTHER||Adjusted Mean|51.0|||||TWO_SIDED|95.0|49.0|53.0|||||The mean predicted cost for emergency department visits for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||53|49|
71085679|NCT01387178|141676743|SUPERIORITY_OR_OTHER||Adjusted Mean|231.0|||||TWO_SIDED|95.0|227.0|234.0|||||The mean predicted cost for office visits for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||234|227|
71085680|NCT01387178|141676743|SUPERIORITY_OR_OTHER||Adjusted Mean|295.0|||||TWO_SIDED|95.0|290.0|299.0|||||The mean predicted cost for office visits for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||299|290|
71085681|NCT01387178|141676743|SUPERIORITY_OR_OTHER||Adjusted Mean|873.0|||||TWO_SIDED|95.0|827.0|919.0|||||The mean predicted cost for other outpatient and ancillary services for FSC participants. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||919|827|
71085682|NCT01387178|141676743|SUPERIORITY_OR_OTHER||Adjusted Mean|1080.0|||||TWO_SIDED|95.0|1022.0|1138.0|||||The mean predicted cost for other outpatient and ancillary services for TIO participants. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||1138|1022|
70856694|NCT00420641|141199976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.14|TWO_SIDED|90.0|0.41|1.05|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 6.||1.05|0.41|0.1400
70856695|NCT00420641|141199976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.71||||0.0002|TWO_SIDED|90.0|1.74|4.21|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 6.||4.21|1.74|0.0002
70856696|NCT00420641|141199976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9596|TWO_SIDED|90.0|0.59|1.64|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 8.||1.64|0.59|0.9596
70856697|NCT00420641|141199976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.24||||0|TWO_SIDED|90.0|2.01|5.23|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 8.||5.23|2.01|0.0000
70856698|NCT00420641|141199976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.653|TWO_SIDED|90.0|0.69|1.93|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 10.||1.93|0.69|0.6530
70856699|NCT00420641|141199976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.48||||0|TWO_SIDED|90.0|2.11|5.73|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 10.||5.73|2.11|0.0000
70856700|NCT00420641|141199976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.8844|TWO_SIDED|90.0|0.23|3.48|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 1.||3.48|0.23|0.8844
70856701|NCT00420641|141199976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.7425|TWO_SIDED|90.0|0.36|4.68|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 1.||4.68|0.36|0.7425
70856702|NCT00420641|141199976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.8355|TWO_SIDED|90.0|0.39|2.07|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 2.||2.07|0.39|0.8355
70856703|NCT00420641|141199976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93||||0.1786|TWO_SIDED|90.0|0.86|4.32|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 2.||4.32|0.86|0.1786
70856704|NCT00420641|141199976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5||||0.0835|TWO_SIDED|90.0|0.26|0.97|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 3.||0.97|0.26|0.0835
71085683|NCT01387178|141676743|SUPERIORITY_OR_OTHER||Adjusted Mean|1267.0|||||TWO_SIDED|95.0|1251.0|1283.0|||||The mean predicted cost for pharmacy services for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||1283|1251|
71085684|NCT01387178|141676743|SUPERIORITY_OR_OTHER||Adjusted Mean|1250.0|||||TWO_SIDED|95.0|1234.0|1266.0|||||The mean predicted cost for pharmacy services for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||1266|1234|
71085685|NCT01387178|141676743|SUPERIORITY_OR_OTHER||Adjusted Mean|1175.0|||||TWO_SIDED|95.0|1083.0|1267.0|||||The mean predicted cost for inpatient and emergency department services for FSC participants. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||1267|1083|
71085686|NCT01387178|141676743|SUPERIORITY_OR_OTHER||Adjusted Mean|1566.0|||||TWO_SIDED|95.0|1438.0|1695.0|||||The mean predicted cost for inpatient and emergency department services for TIO participants. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||1695|1438|
71085687|NCT01387178|141676743|SUPERIORITY_OR_OTHER||Adjusted Mean|2991.0|||||TWO_SIDED|95.0|2922.0|3059.0|||||The mean predicted cost for total healthcare services for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||3059|2922|
71123512|NCT00853840|141752724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05||||||90.0|-5.91|1.81|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"4 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||1.81|-5.91|
71123513|NCT00853840|141752724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09||||||90.0|-3.46|1.27|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"4 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||1.27|-3.46|
71085688|NCT01387178|141676743|SUPERIORITY_OR_OTHER||Adjusted Mean|3304.0|||||TWO_SIDED|95.0|3221.0|3386.0|||||The mean predicted cost for total healthcare services for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||3386|3221|
71085689|NCT01387178|141676744|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.964||||0.2198||95.0|0.909|1.022||Risk of Moderate COPD Exacerbations|Regression, Cox|||||1.022|0.909|0.2198
71085690|NCT01387178|141676744|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.864||||0.0406||95.0|0.752|0.994||Risk of Severe COPD Exacerbations|Regression, Cox|||||0.994|0.752|0.0406
71085691|NCT01387178|141676744|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.953||||0.0962||95.0|0.901|1.009||Risk of Any COPD Exacerbation|Regression, Cox|||||1.009|0.901|0.0962
71085692|NCT03421379|141676762|NON_INFERIORITY|The pre-defined non-inferiority margin is (10%)|Treatment Difference Wald's Method|0.0|||||TWO_SIDED|95.0|-1.47|1.47||||||||1.47|-1.47|
71085693|NCT02782741|141676768|NON_INFERIORITY|NI was demonstrated if the lower bound of the 2-sided 95% confidence interval (CI) for the difference of avalglucosidase alfa minus alglucosidase alfa was greater than (\>) -1.1.|LS mean difference|2.43|STANDARD_ERROR_OF_MEAN|1.29||0.0074|TWO_SIDED|95.0|-0.13|4.99|||mixed model for repeated measures|||Analysis performed using MMRM model with baseline FVC (% predicted, as continuous), sex, age (in years at baseline), treatment group, visit, interaction term between treatment group and visit as fixed effects.||4.99|-0.13|0.0074
70856705|NCT00420641|141199976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.8558|TWO_SIDED|90.0|0.58|1.98|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 3.||1.98|0.58|0.8558
71085694|NCT02782741|141676768|SUPERIORITY|A test for superiority of avalglucosidase alfa versus alglucosidase alfa was performed with an overall 5% level of significance.||||||0.0626||||||Threshold for significance at \<0.05 level.|mixed model for repeated measures|||Analysis performed using MMRM model with baseline FVC (% predicted, as continuous), sex, age (in years at baseline), treatment group, visit, interaction term between treatment group and visit as fixed effects.||||0.0626
71085695|NCT02782741|141676769|SUPERIORITY|Per the protocol-defined statistical test strategy for multiplicity adjustment, and since superiority was narrowly missed for FVC % predicted, superiority testing for the secondary outcome measure couldn't be performed.|LS mean difference|30.01|STANDARD_ERROR_OF_MEAN|14.43||0.0405|TWO_SIDED|95.0|1.33|58.69|||mixed model for repeated measures|||LS mean difference was derived from MMRM model with baseline FVC (% predicted) and baseline 6MWT (distance walked in meter), age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||58.69|1.33|0.0405
70856706|NCT00420641|141199976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.0067|TWO_SIDED|90.0|0.2|0.67|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 4.||0.67|0.20|0.0067
70856707|NCT00420641|141199976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.6647|TWO_SIDED|90.0|0.67|1.98|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 4.||1.98|0.67|0.6647
70856708|NCT00420641|141199976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9553|TWO_SIDED|90.0|0.55|1.74|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 5.||1.74|0.55|0.9553
70856709|NCT00420641|141199976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.58||||0.004||90.0|1.5|4.42|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 5.||4.42|1.50|0.0040
71085696|NCT02782741|141676770|OTHER|Per the protocol-defined statistical test strategy for multiplicity adjustment, and since superiority was narrowly missed for FVC % predicted, superiority testing for the secondary outcome measure couldn't be performed.|LS mean difference|3.13|STANDARD_ERROR_OF_MEAN|5.24||0.5522|TWO_SIDED|95.0|-7.31|13.57|||mixed model for repeated measures|||LS mean difference was derived from MMRM model for MIP % predicted adjusted for MIP % predicted at baseline, age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||13.57|-7.31|0.5522
71085697|NCT02782741|141676771|OTHER|Per the protocol-defined statistical test strategy for multiplicity adjustment, and since superiority was narrowly missed for FVC % predicted, superiority testing for the secondary outcome measure couldn't be performed.|LS mean difference|-1.94|STANDARD_ERROR_OF_MEAN|5.64||0.7321|TWO_SIDED|95.0|-13.17|9.29|||mixed model for repeated measures|||LS mean difference was derived from MMRM model for MEP % predicted adjusted for MEP % predicted at baseline, age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||9.29|-13.17|0.7321
71085698|NCT02782741|141676772|OTHER|Per the protocol-defined statistical test strategy for multiplicity adjustment, and since superiority was narrowly missed for FVC % predicted, superiority testing for the secondary outcome measure couldn't be performed.|LS mean difference|106.97|STANDARD_ERROR_OF_MEAN|67.17||0.115|TWO_SIDED|95.0|-26.56|240.5|||mixed model for repeated measures|||LS mean difference was derived from MMRM model for HHD lower extremity muscle strength composite score adjusted for summary HHD lower extremity score at baseline, baseline FVC (% predicted), age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||240.50|-26.56|0.1150
71085699|NCT02782741|141676773|OTHER|No formal testing of additional secondary endpoint of QMFT.|LS mean difference|2.08|STANDARD_ERROR_OF_MEAN|0.94||0.0288|TWO_SIDED|95.0|0.22|3.95||Nominal p-value.|mixed model for repeated measures|||LS mean difference was derived from MMRM models adjust for total QMFT score at baseline, baseline FVC (% predicted), age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||3.95|0.22|0.0288
71085700|NCT02782741|141676774|OTHER|No formal testing of additional secondary endpoint of SF-12.|Score difference|0.77|STANDARD_ERROR_OF_MEAN|1.46||0.5996|TWO_SIDED|95.0|-2.13|3.67|||mixed model for repeated measures|||The MMRM models adjust for baseline score (PCS), baseline FVC (% predicted), age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||3.67|-2.13|0.5996
71085701|NCT02782741|141676774|OTHER|No formal testing of additional secondary endpoint of SF-12.|Score difference|2.12|STANDARD_ERROR_OF_MEAN|1.8||0.2427|TWO_SIDED|95.0|-1.46|5.69|||mixed model for repeated measures|||The MMRM models adjust for baseline score (MCS), baseline FVC (% predicted), age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||5.69|-1.46|0.2427
71085702|NCT04195061|141676803|SUPERIORITY|||||||0.303|||||||t-test, 2 sided|||||||0.303
71085703|NCT04195061|141676804|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||0.035
71085704|NCT04195061|141676805|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||0.007
71085705|NCT00196105|141676811|SUPERIORITY_OR_OTHER|||||||0.057||95.0|||||Log Rank|||||||.057
71085706|NCT00196105|141676812|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Chi-squared|||||||.04
71085707|NCT00196105|141676812|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||Death is censored for Kaplan-Meier analysis.|Log Rank|||||||.007
71085708|NCT00196105|141676812|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Chi-squared|||||||.69
71085709|NCT00196105|141676812|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||P-value is adjusted for multiple comparisons.|Chi-squared|||6 mm Zilver vs. 10 mm Zilver and 10 mm Wallstent combined||||.02
71085710|NCT00196105|141676813|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||||||.16
71085711|NCT00196105|141676815|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Log Rank|||||||.32
71085712|NCT00196105|141676815|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Kruskal-Wallis|||||||.69
71085713|NCT04863872|141676816|OTHER|Difference|Risk Ratio (RR)|0.72||||0.27|TWO_SIDED|95.0|0.39|1.3|||Poisson regression|Poisson regression with binary primary outcome, estimated using Generalized Estimating Equations (GEE) and robust variance estimation.||||1.30|0.39|0.27
70856710|NCT00420641|141199976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.6327|TWO_SIDED|90.0|0.52|1.43|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 6.||1.43|0.52|0.6327
70856711|NCT00420641|141199976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.36||||0.0027|TWO_SIDED|90.0|1.47|3.79|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 6.||3.79|1.47|0.0027
71123514|NCT00853840|141752724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||||90.0|-6.16|1.56|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"6 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||1.56|-6.16|
71123515|NCT00853840|141752724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.43||||||90.0|-5.79|-1.06|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"6 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-1.06|-5.79|
71123516|NCT00853840|141752724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47||||||90.0|-7.33|0.39|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"8 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.39|-7.33|
71123517|NCT00853840|141752724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.26||||||90.0|-5.62|-0.9|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"8 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.90|-5.62|
71123518|NCT00853840|141752724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||||90.0|-4.13|3.59|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"12 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||3.59|-4.13|
71123519|NCT00853840|141752724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.26||||||90.0|-4.62|0.1|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"12 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.10|-4.62|
71123520|NCT00853840|141752725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.95||||||90.0|4.18|9.72|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"1.5 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||9.72|4.18|
70944935|NCT01917006|141390478|SUPERIORITY||Least square mean difference|0.16||||0.33||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 2||||0.330
70856712|NCT00420641|141199976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.3961|TWO_SIDED|90.0|0.45|1.29|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 8.||1.29|0.45|0.3961
70856713|NCT00420641|141199976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.89||||0.0298|TWO_SIDED|90.0|1.17|3.06|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 8.||3.06|1.17|0.0298
71123521|NCT00853840|141752725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.51||||||90.0|2.73|8.28|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||8.28|2.73|
71123522|NCT00853840|141752725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.64||||||90.0|0.87|6.42|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2.5 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||6.42|0.87|
71123523|NCT00853840|141752725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.89||||||90.0|0.12|5.67|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"3 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||5.67|0.12|
71123524|NCT00853840|141752725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.06||||||90.0|-0.71|4.83|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"4 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||4.83|-0.71|
71123525|NCT00853840|141752725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.45||||||90.0|2.68|8.22|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"6 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||8.22|2.68|
71123526|NCT00853840|141752725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.12||||||90.0|1.34|6.89|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"8 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||6.89|1.34|
71123527|NCT00853840|141752725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.45||||||90.0|0.68|6.22|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"12 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||6.22|0.68|
71123528|NCT00853840|141752725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.33||||||90.0|3.7|10.95|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"1.5 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||10.95|3.70|
70856714|NCT00420641|141199976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.8826|TWO_SIDED|90.0|0.56|1.61|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 10.||1.61|0.56|0.8826
70856715|NCT00420641|141199976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.48||||0.0022|TWO_SIDED|90.0|1.52|4.05|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 10.||4.05|1.52|0.0022
70856716|NCT00420641|141199977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.5072|TWO_SIDED|90.0|0.22|1.89|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 1.||1.89|0.22|0.5072
71123529|NCT00853840|141752725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.83||||||90.0|3.2|10.45|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||10.45|3.20|
71123530|NCT00853840|141752725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.02||||||90.0|1.4|8.65|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2.5 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||8.65|1.40|
71123531|NCT00853840|141752725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.72||||||90.0|1.09|8.34|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"3 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||8.34|1.09|
70856717|NCT00420641|141199977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.6886|TWO_SIDED|90.0|0.52|2.93|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 1.||2.93|0.52|0.6886
70856718|NCT00420641|141199977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.8664|TWO_SIDED|90.0|0.56|2.04|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 2.||2.04|0.56|0.8664
70856719|NCT00420641|141199977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.2897|TWO_SIDED|90.0|0.8|2.79|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 2.||2.79|0.80|0.2897
70856720|NCT00420641|141199977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||0.2474|TWO_SIDED|90.0|0.39|1.18|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 3.||1.18|0.39|0.2474
70856721|NCT00420641|141199977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.2007|TWO_SIDED|90.0|0.89|2.47|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 3.||2.47|0.89|0.2007
70856722|NCT00420641|141199977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.0214|TWO_SIDED|90.0|0.29|0.82|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 4.||0.82|0.29|0.0214
70856723|NCT00420641|141199977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.2368|TWO_SIDED|90.0|0.88|2.23|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 4.||2.23|0.88|0.2368
70856724|NCT00420641|141199977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.987|TWO_SIDED|90.0|0.63|1.59|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 5.||1.59|0.63|0.9870
70856725|NCT00420641|141199977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.0193|TWO_SIDED|90.0|1.21|3.0|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 5.||3.00|1.21|0.0193
70944936|NCT01917006|141390478|SUPERIORITY||Least square mean difference|0.3||||0.199||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 2||||0.199
71085714|NCT01691378|141676863|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.03|TWO_SIDED|95.0|0.52|8.3|||ANCOVA|||"Analyses 2-sided test w/ sig level .05. N=35 analyzed w/ α .05 provided 80% power to detect effect size d=1. T1 variables compared using Wilcoxon rank sum \& Fisher exact tests. Per protocol analysis, all participants required T2 BHS.~T2 BHS compared bet arms controlling for T1 BHS. No confounders significant at .10, not included in model. Analysis of covariance modeled T2 BHS as function of arm \& T1 BHS. Estimated mean difference in T2 scores calculated, no adjustment for multiple comparisons."||8.3|.52|.03
71085715|NCT01691378|141676863|SUPERIORITY||Mean Difference (Final Values)|-4.6||||0.01|TWO_SIDED|95.0|-7.9|-1.3|||Regression, Linear|||"Analysis contrasted T1 to T2 change with T2 to T3 change in Waitlist arm only. Waitlist participants serve as their own control \& only variable controlled for was change in Waitlist period (if participants improved greatly during Waitlist period, they would no longer have enough room to change in Intervention period). Linear regression used with difference in change as dependent variable \& Waitlist period change as only predictor. Estimated mean difference in change calculated from this model."||-1.3|-7.9|.01
71085716|NCT01691378|141676863|SUPERIORITY||Mean Difference (Final Values)|-6.3||||0.0007|TWO_SIDED|95.0|-9.3|-3.2|||one-sample t-test|||Analysis investigated change from T1 to T3 within the WtoH Intervention first arm only. This difference was calculated and a 1-sample t test was used to determine whether the estimate was different from zero. As this change was not compared with a control group change, baseline values were not accounted for.||-3.2|-9.3|.0007
71085717|NCT01691378|141676864|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.07|TWO_SIDED|95.0|-0.29|8.0|||ANCOVA|||"Analyses 2-sided test w/ sig level .05. N=35 analyzed w/ α .05 provided 80% power to detect effect size d=1. T1 variables compared using Wilcoxon rank sum \& Fisher exact tests. Per protocol analysis, all participants required T2 BHS.~T2 BSS compared bet arms controlling for T1 BSS. No confounders significant at .10, not included in model. Analysis of covariance modeled T2 BSS as function of arm \& T1 BSS. Estimated mean difference in T2 scores calculated, no adjustment for multiple comparisons."||8.0|-.29|.07
71085718|NCT01691378|141676864|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.94|TWO_SIDED|95.0|-3.3|3.1|||Regression, Linear|||"Analysis contrasted T1 to T2 change with T2 to T3 change in Waitlist arm only. Waitlist participants serve as their own control \& only variable controlled for was change in Waitlist period (if participants improved greatly during Waitlist period, they would no longer have enough room to change in Intervention period). Linear regression used with difference in change as dependent variable \& Waitlist period change as only predictor. Estimated mean difference in change calculated from this model."||3.1|-3.3|.94
71085719|NCT01691378|141676864|SUPERIORITY||Mean Difference (Final Values)|-3.5||||0.06|TWO_SIDED|95.0|-7.0|0.12|||one-sample t-test|||Analysis investigated change from T1 to T3 within the WtoH Intervention first arm only. This difference was calculated and a 1-sample t test was used to determine whether the estimate was different from zero. As this change was not compared with a control group change, baseline values were not accounted for.||.12|-7.0|.06
71085720|NCT01691378|141676865|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.13|TWO_SIDED|95.0|-1.7|12.9|||ANCOVA|||"Analyses 2-sided test w/ sig level .05. N=35 analyzed w/ α .05 provided 80% power to detect effect size d=1. T1 variables compared using Wilcoxon rank sum \& Fisher exact tests. Per protocol analysis, all participants required T2 BHS.~T2 BDI compared bet arms controlling for T1 BDI. No confounders significant at .10, not included in model. Analysis of covariance modeled T2 BDI as function of arm \& T1 BDI. Estimated mean difference in T2 scores calculated, no adjustment for multiple comparisons."||12.9|-1.7|.13
71085721|NCT01691378|141676865|SUPERIORITY||Mean Difference (Final Values)|-8.7||||0.003|TWO_SIDED|95.0|-13.8|-3.6|||Regression, Linear|||"Analysis contrasted T1 to T2 change with T2 to T3 change in Waitlist arm only. Waitlist participants serve as their own control \& only variable controlled for was change in Waitlist period (if participants improved greatly during Waitlist period, they would no longer have enough room to change in Intervention period). Linear regression used with difference in change as dependent variable \& Waitlist period change as only predictor. Estimated mean difference in change calculated from this model."||-3.6|-13.8|.003
71085722|NCT01691378|141676865|SUPERIORITY||Mean Difference (Final Values)|-11.6||||0.002|TWO_SIDED|95.0|-18.0|-5.3|||one-sample t-test|||Analysis investigated change from T1 to T3 within the WtoH Intervention first arm only. This difference was calculated and a 1-sample t test was used to determine whether the estimate was different from zero. As this change was not compared with a control group change, baseline values were not accounted for.||-5.3|-18.0|.002
71085723|NCT02849080|141676866|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Odds Ratio (OR)|4.4|||<|0.0001|TWO_SIDED|95.0|2.89|6.7||Unadjusted two-sided p-value for test of no difference from 1.|Pattern mixture model||Oral Semaglutide flex / Sitagliptin 100 mg.|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 52 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using a logistic regression model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete datasets, and pooled by Rubin's rule to draw inference.||6.70|2.89|<0.0001
71123532|NCT00853840|141752725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.05||||||90.0|0.43|7.67|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"4 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||7.67|0.43|
71123533|NCT00853840|141752725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.36||||||90.0|2.73|9.98|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"6 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||9.98|2.73|
70856726|NCT00420641|141199977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.8351|TWO_SIDED|90.0|0.59|1.5|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 6.||1.50|0.59|0.8351
70856727|NCT00420641|141199977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.01||||0.0001|TWO_SIDED|90.0|1.9|4.77|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 6.||4.77|1.90|0.0001
70856728|NCT00420641|141199977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.751|TWO_SIDED|90.0|0.67|1.8|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 8.||1.80|0.67|0.7510
70944937|NCT01917006|141390478|SUPERIORITY||Least square mean difference|0.45||||0.113||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 2||||0.113
71085724|NCT02849080|141676866|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Odds Ratio (OR)|5.54|||<|0.0001|TWO_SIDED|95.0|3.54|8.68||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Logistic||Oral Semaglutide flex / Sitagliptin 100 mg|The analysis was based on multiple imputation, imputing sequentially using post-baseline measurements up to and including week 52. The imputed data sets were analysed using a logistic regression model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete datasets, and pooled by Rubin's rule to draw inference.||8.68|3.54|<0.0001
71085725|NCT02849080|141676867|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.2||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixture model||Oral semaglutide flex - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 52 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using a logistic regression model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete datasets, and pooled by Rubin's rule to draw inference.||-1.2|-2.6|<0.0001
70856729|NCT00420641|141199977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.37||||0.0029|TWO_SIDED|90.0|1.47|3.8|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 8.||3.80|1.47|0.0029
70856730|NCT00420641|141199977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.1707|TWO_SIDED|90.0|0.92|2.55|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 10.||2.55|0.92|0.1707
70856731|NCT00420641|141199977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.27||||0.0001|TWO_SIDED|90.0|1.99|5.36|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 10.||5.36|1.99|0.0001
70856732|NCT00420641|141199977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||0.205|TWO_SIDED|90.0|0.05|1.48|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 1.||1.48|0.05|0.2050
70856733|NCT00420641|141199977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.1735|TWO_SIDED|90.0|0.11|1.24|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 1.||1.24|0.11|0.1735
71085726|NCT02849080|141676867|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-2.2|||<|0.0001|TWO_SIDED|95.0|-2.9|-1.5||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide flex - Sitagliptin 100 mg|The analysis was based on a Mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 52. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.5|-2.9|<0.0001
71085727|NCT02849080|141676884|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.18|||<|0.0001|TWO_SIDED|95.0|0.09|0.39||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide flex / Sitagliptin 100 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.39|0.09|<0.0001
71123534|NCT00853840|141752725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.08||||||90.0|1.45|8.7|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"8 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||8.70|1.45|
71123535|NCT00853840|141752725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.88||||||90.0|-1.74|5.51|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"12 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||5.51|-1.74|
71123536|NCT01710527|141752739|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Treatment T-Metformin 500 mg with Treatment R- Glucophage 500 mg was concluded if the 90% confidence intervals for the ratio of log transformed Cmax fell within the acceptance range of 80 to 125%.|Ratio (%)|96.85||||0.3125|TWO_SIDED|90.0|91.86|102.11|||ANOVA||Analysis was performed on log transformed geometric least square means.|||102.11|91.86|0.3125
71123537|NCT01710527|141752740|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Treatment T-Metformin 500 mg with Treatment R- Glucophage 500 mg was concluded if the 90% confidence intervals for the ratio of log transformed AUC0-t fell within the acceptance range of 80 to 125%.|Ratio (%)|102.52||||0.2701|TWO_SIDED|90.0|98.74|106.45|||ANOVA|||Comparison of Treatment T-Metformin 500 mg and Treatment R- Glucophage 500 mg for AUC0-t||106.45|98.74|0.2701
70944938|NCT01917006|141390478|SUPERIORITY||Least square mean difference|0.5||||0.127||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 4||||0.127
71085728|NCT02849080|141676885|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.58||||0.0175|TWO_SIDED|95.0|0.37|0.91||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide flex / Sitagliptin 100 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before planned end of treatment.||0.91|0.37|0.0175
71085729|NCT02849080|141676904|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.77||||0.4381|TWO_SIDED|95.0|0.39|1.5||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide flex- Switch / Sitagliptin 100 mg- Switch|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before planned end of treatment.||1.50|0.39|0.4381
71085730|NCT02849080|141676905|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.47||||0.079|TWO_SIDED|95.0|0.2|1.09||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide flex- Switch / Sitagliptin 100 mg- Switch|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||1.09|0.20|0.0790
71085731|NCT02155985|141676938|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4||||0.7|TWO_SIDED|95.0|-5.5|8.8||While there are co-primary comparisons, due to the pilot nature of the study, no adjustment to the 0.05 type I error was made.|t-test, 2 sided||Mean difference is the percent difference in mean fold changes = ((300 mg mean fold change / placebo mean fold change) - 1) \* 100.|Paired differences between the two aspirin arms and placebo were estimated in a single linear regression model using linear combinations of the estimated means.||8.8|-5.5|0.70
71085732|NCT02155985|141676938|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.5||||0.14|TWO_SIDED|95.0|-1.7|13.3||While there are co-primary comparisons, due to the pilot nature of the study, no adjustment to the 0.05 type I error was made.|t-test, 2 sided||Mean difference is the percent difference in mean fold changes = ((100 mg mean fold change / placebo mean fold change) - 1) \* 100.|Paired differences between the two aspirin arms and placebo were estimated in a single linear regression model using linear combinations of the estimated means.||13.3|-1.7|0.14
71085733|NCT03110133|141676963|SUPERIORITY|||||||0.0488|||||||Chi-squared|||||||0.0488
71085734|NCT03110133|141676966|SUPERIORITY|||||||0.0347|||||||Chi-squared|||||||0.0347
71085735|NCT03718429|141677001|SUPERIORITY|In line with recommendations for pilot investigations, since there were no preliminary data exploring the pharmacodynamic effects of vascular dose rivaroxaban in addition to antiplatelet therapy, we arbitrarily chose a sample size of 20 patients per treatment cohort.||||||0.275|||||||Wilcoxon (Mann-Whitney)|||||||0.275
71085736|NCT03718429|141677002|SUPERIORITY|||||||0.488|||||||Wilcoxon (Mann-Whitney)|||||||0.488
71085737|NCT03718429|141677003|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71085738|NCT00325819|141677026|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.66||||0.053|TWO_SIDED|95.0|0.41|1.01|||unadjusted Poisson regression|||The study sample size of 1000 children was selected to have 80% power to detect a 30% reduction in risk of the primary outcome of rectal temperature \>=38 following vaccination. In 2009, during the enrollment period of our trial, another paper reported the results of a randomized trial of acetaminophen prophylaxis in infants which found significantly lower immune responses to various vaccines in the acetaminophen group. In light of thse findings we elected to stop enrollment in our trial.||1.01|0.41|0.053
71085739|NCT00325819|141677027|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.0||||0.08||95.0|||||Fisher Exact|||||||0.08
70856734|NCT00420641|141199977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93||||0.2305|TWO_SIDED|90.0|0.78|4.75|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 2.||4.75|0.78|0.2305
71085740|NCT00325819|141677028|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.31||||0.02|TWO_SIDED|95.0|0.12|0.84|||unadjusted Poisson regression|||||0.84|0.12|0.02
71085741|NCT00325819|141677029|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.45||||0.14|TWO_SIDED|95.0|0.16|1.28|||unadjusted Poisson regression|||||1.28|0.16|0.14
71085742|NCT00325819|141677030|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.4||||0.001|TWO_SIDED|95.0|0.25|0.7|||unadjusted Poisson regression|||||0.70|0.25|0.001
71085743|NCT00325819|141677031|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.62||||0.4|TWO_SIDED|95.0|0.21|1.88|||unadjusted Poisson regression|||||1.88|0.21|0.40
71085744|NCT00325819|141677032|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|0.25|3.94|||unadjusted Poisson regression|||||3.94|0.25|1.00
71085745|NCT00325819|141677033|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.94||||0.18|TWO_SIDED|95.0|0.6|14.34|||unadjusted Poisson regression|||||14.34|0.60|0.18
71085746|NCT03574974|141677062|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||0.047
71085747|NCT01466361|141677068|SUPERIORITY_OR_OTHER||Least square mean difference|-7.23||||0.0643|TWO_SIDED|95.0|-14.89|0.44|||ANCOVA||Treatment comparisons were made between nicotine 1.5mg lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings at 1 minute post dosing.||0.44|-14.89|0.0643
71085748|NCT01466361|141677068|SUPERIORITY_OR_OTHER||Least square mean difference|-7.16||||0.1489|TWO_SIDED|95.0|-16.93|2.61|||ANCOVA||Treatment comparisons were made between nicotine 1.5mg lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings at 3 minute post dosing.||2.61|-16.93|0.1489
71085749|NCT01466361|141677068|SUPERIORITY_OR_OTHER||Least square mean difference|-6.33||||0.2225|TWO_SIDED|95.0|-16.56|3.9|||ANCOVA||Treatment comparisons were made between 1.5mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings at 5 minute post dosing.||3.90|-16.56|0.2225
71123538|NCT01710527|141752740|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Treatment T-Metformin 500 mg with Treatment R- Glucophage 500 mg was concluded if the 90% confidence intervals for the ratio of log transformed AUC0-infinity fell within the acceptance range of 80 to 125%.|Ratio (%)|102.44||||0.2702|TWO_SIDED|90.0|98.78|106.23|||ANOVA||Analysis was performed on log transformed geometric least square means.|Comparison of Treatment T-Metformin 500 mg and Treatment R- Glucophage 500 mg for AUC0-infinity.||106.23|98.78|0.2702
71123539|NCT01075971|141752776|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.77|||<|0.0001|TWO_SIDED|95.0|1.35|2.19||Analysis of variance with repeated measurements (daily scores from day 1 to day 5) for the whole set of patients was performed adjusted on the formulation (SL vs. FDT). Other independent factors were the subject and the day.|Analysis of variance|||||2.19|1.35|<0.0001
71123540|NCT02358044|141752805|NON_INFERIORITY_OR_EQUIVALENCE|The lower bound of 95% CIs was compared to pre-specified non-inferiority margin, -10% to evaluate non-inferiority. The Missing=Failure (M=F) approach was used to handle missing values.|Adjusted Difference in Percentage|8.8|||<|0.001|TWO_SIDED|95.0|3.6|15.3|||Miettinen & Nurminen Method|||"Primary Analysis Approach: Non-Inferiority~Analyses of the percentage of participants achieving SVR12 was conducted using the Miettinen \& Nurminen (M\&N) method. The analysis was adjusted for genotype (1a vs. non-1a) and fibrosis stage (cirrhotic vs. non-cirrhotic). The adjusted differences (grazoprevir+elbasvir arm minus SOF+PR arm) in percentages along with the corresponding 95% confidence intervals (CIs) and p-values were provided."||15.3|3.6|<0.001
71123541|NCT02358044|141752805|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentage|8.8||||0.001|TWO_SIDED|95.0|3.6|15.3|||Miettinen & Nurminen Method|The lower bound of 95% CIs was compared to zero to evaluate superiority. The M=F approach was used to handle missing values.||"Secondary Analysis Approach: Superiority~Analyses of the percentage of participants achieving SVR12 was conducted using the M\&N method. The analysis was adjusted for genotype (1a vs. non-1a) and fibrosis stage (cirrhotic vs. non-cirrhotic). The adjusted differences (grazoprevir +elbasvir arm minus SOF+PR arm) in percentages along with the corresponding 95% CIs and p-values were provided."||15.3|3.6|0.001
71123542|NCT02358044|141752806|SUPERIORITY_OR_OTHER||Difference in Percentage|-41.7|||||TWO_SIDED|95.0|-51.1|-31.9||||||The percentage of participants with an event were assessed via point estimates with 95% CIs provided for between-group comparisons.||-31.9|-51.1|
71123543|NCT02358044|141752808|SUPERIORITY_OR_OTHER||Difference in Percentage|-27.0|||<|0.001|TWO_SIDED|95.0|-35.5|-19.6||% of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M\&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.|Miettinen & Nurminen Method|||"Total Tier 1 AEs:~If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event."||-19.6|-35.5|<0.001
71123544|NCT02358044|141752808|SUPERIORITY_OR_OTHER||Difference in Percentage|-2.4||||0.078|TWO_SIDED|95.0|-6.8|0.6||% of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M\&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.|Miettinen & Nurminen Method|||"Serious drug-related AEs:~If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event."||0.6|-6.8|0.078
71123545|NCT02358044|141752808|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.8||||0.312|TWO_SIDED|95.0|-4.4|2.1||% of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M\&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.|Miettinen & Nurminen Method|||"DC due to drug-related AE:~If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event."||2.1|-4.4|0.312
71123546|NCT02358044|141752808|SUPERIORITY_OR_OTHER||Difference in Percentage|-12.7|||<|0.001|TWO_SIDED|95.0|-19.7|-8.0||% of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M\&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.|Miettinen & Nurminen Method|||"Neutrophil count \<0.75 x 10\^9/L:~If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event."||-8.0|-19.7|<0.001
70856735|NCT00420641|141199977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.86||||0.2507|TWO_SIDED|90.0|0.77|4.5|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 2.||4.50|0.77|0.2507
70856736|NCT00420641|141199977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.5608|TWO_SIDED|90.0|0.35|1.64|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 3.||1.64|0.35|0.5608
71085750|NCT01466361|141677068|SUPERIORITY_OR_OTHER||Least square mean difference|-5.11||||0.3491|TWO_SIDED|95.0|-15.87|5.66|||ANCOVA||Treatment comparisons were made between 1.5mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings, 10 minutes post dosing.||5.66|-15.87|0.3491
70856737|NCT00420641|141199977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.6526|TWO_SIDED|90.0|0.6|2.42|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 3.||2.42|0.60|0.6526
71085751|NCT01466361|141677068|SUPERIORITY_OR_OTHER||Least square mean difference|-5.0||||0.3936|TWO_SIDED|95.0|-16.6|6.59|||ANCOVA||Treatment comparisons were made between 1.5mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings, 15 minutes post dosing.||6.59|-16.60|0.3936
70856738|NCT00420641|141199977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41||||0.0208|TWO_SIDED|90.0|0.21|0.77|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 4.||0.77|0.21|0.0208
70856739|NCT00420641|141199977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.2859|TWO_SIDED|90.0|0.39|1.22|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 4.||1.22|0.39|0.2859
70856740|NCT00420641|141199977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.7921|TWO_SIDED|90.0|0.49|1.66|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 5.||1.66|0.49|0.7921
70856741|NCT00420641|141199977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.362|TWO_SIDED|90.0|0.79|2.31|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 5.||2.31|0.79|0.3620
71123547|NCT02358044|141752808|SUPERIORITY_OR_OTHER||Difference in Percentage|-13.5|||<|0.001|TWO_SIDED|95.0|-20.8|-7.9||% of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M\&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.|Miettinen & Nurminen Method|||"Hemoglobin \<10 g/dL:~If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event."||-7.9|-20.8|<0.001
71123548|NCT02358044|141752809|NON_INFERIORITY_OR_EQUIVALENCE|The lower bound of 95% CIs was compared to pre-specified non-inferiority margin, -10% to evaluate non-inferiority. The Missing=Failure (M=F) approach was used to handle missing values.|Adjusted Difference in Percentage|8.8|||||TWO_SIDED|95.0|3.3|15.7||||||Analyses of the percentage of participants achieving SVR24 was conducted using the Miettinen \& Nurminen (M\&N) method. The analysis was adjusted for genotype (1a vs. non-1a) and fibrosis stage (cirrhotic vs. non-cirrhotic). The adjusted differences (grazoprevir+elbasvir arm minus SOF+PR arm) in percentages along with the corresponding 95% confidence intervals (CIs) and p-values were provided.||15.7|3.3|
71123549|NCT01739803|141752811|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||To control for experiment-wise Type I error rate in this analysis, a comparison-wise alpha of 0.01 was used.|Mixed Models Analysis|||We projected mean composite adherence rate for all participants to be approximately 80% ± 15. We anticipated at least 10% increase in intervention group adherence at end of intervention. To have 80% power to detect expected difference of 10% at the 2-tailed 5% significance level, sample size needed to be at least 36 RTRs per group. We took a conservative approach, in combination with anticipated attrition over the course of study, and increased enrollment.||||<0.05
71123550|NCT01739803|141752812|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.05
70856742|NCT00420641|141199977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.4331|TWO_SIDED|90.0|0.44|1.34|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 6.||1.34|0.44|0.4331
70856743|NCT00420641|141199977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3||||0.0047|TWO_SIDED|90.0|1.42|3.75|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 6.||3.75|1.42|0.0047
71123551|NCT01739803|141752813|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.05||||0.05|TWO_SIDED|95.0|||||Chi-squared|||||||0.05
70856744|NCT00420641|141199977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.4431|TWO_SIDED|90.0|0.46|1.32|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 8.||1.32|0.46|0.4431
70856745|NCT00420641|141199977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.1901|TWO_SIDED|90.0|0.9|2.44|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 8.||2.44|0.90|0.1901
70856746|NCT00420641|141199977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.9222|TWO_SIDED|90.0|0.56|1.66|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 10.||1.66|0.56|0.9222
70856747|NCT00420641|141199977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.1665|TWO_SIDED|90.0|0.93|2.43|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 10.||2.43|0.93|0.1665
71085752|NCT01466361|141677069|SUPERIORITY_OR_OTHER||Least square mean difference|-3.58||||0.3922|TWO_SIDED|95.0|-11.85|4.7|||ANCOVA||Treatment comparisons were made between 4mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings, at 1 minute post dosing.||4.70|-11.85|0.3922
71123552|NCT01428336|141752814|NON_INFERIORITY|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|0.06|||||TWO_SIDED|95.0|-0.2|0.6||||||Analysis comparing Peak 25ug CST correlation with ITT vs. Peak 1ug CST correlation with ITT||0.60|-0.20|
71123553|NCT01428336|141752814|NON_INFERIORITY|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|-0.07|||||TWO_SIDED|95.0|-0.69|-0.01||||||Analysis comparing Peak 25ug CST correlation with ITT vs. Peak 250ug CST correlation with ITT||-0.01|-0.69|
71123554|NCT01428336|141752814|NON_INFERIORITY|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|-0.06|||||TWO_SIDED|95.0|-0.65|0.04||||||Analysis comparing Peak 25ug CST correlation with ITT vs. 30-minute 250ug CST correlation with ITT||0.04|-0.65|
71123555|NCT01428336|141752815|NON_INFERIORITY|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|0.12|||||TWO_SIDED|95.0|-0.24|0.65||||||Analysis comparing Peak 25ug CST correlation with ITT vs. Peak 1ug CST correlation with ITT - free cortisol||0.65|-0.24|
70944939|NCT01917006|141390478|SUPERIORITY||Least square mean difference|0.56||||0.087||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 4||||0.087
71123556|NCT01428336|141752815|NON_INFERIORITY|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|-0.18|||||TWO_SIDED|95.0|-0.91|-0.15||||||Analysis comparing Peak 25ug CST correlation with ITT vs. Peak 250ug CST correlation with ITT - free cortisol||-0.15|-0.91|
71123557|NCT01428336|141752815|NON_INFERIORITY|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|-0.19|||||TWO_SIDED|95.0|-0.94|-0.14||||||Analysis comparing Peak 25ug CST correlation with ITT vs. 30-minute 250ug CST correlation with ITT - free cortisol||-0.14|-0.94|
71123558|NCT02525094|141752826|SUPERIORITY||Odds Ratio (OR)|1.97|||||TWO_SIDED|95.0|0.9|4.33||||||||4.33|0.90|
71123559|NCT01831817|141752883|SUPERIORITY_OR_OTHER||Mean change difference|-0.1||||0.4321|TWO_SIDED|95.0|-0.35|0.15|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference was First named treatment-second named treatment that a negative difference implied the mean of the second named treatment was larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||0.15|-0.35|0.4321
71123560|NCT01831817|141752883|SUPERIORITY_OR_OTHER||Mean change difference|-0.48||||0.0002|TWO_SIDED|95.0|-0.73|-0.23|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is First named treatment - second named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||-0.23|-0.73|0.0002
71123561|NCT01831817|141752883|SUPERIORITY_OR_OTHER||Mean change difference|-0.49||||0.0002|TWO_SIDED|95.0|-0.74|-0.24|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is First named treatment - second named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||-0.24|-0.74|0.0002
70944940|NCT01917006|141390478|SUPERIORITY||Least square mean difference|-0.04||||0.543||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 4||||0.543
71085753|NCT01466361|141677069|SUPERIORITY_OR_OTHER||Least square mean difference|-9.7||||0.0547|TWO_SIDED|95.0|-19.59|0.2|||ANCOVA||Treatment comparisons were made between 4mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings, 3 minutes post dosing.||0.20|-19.59|0.0547
71085754|NCT01921517|141677083|SUPERIORITY|||||||0.0481|||||||t-test, 2 sided|||||||0.0481
71123562|NCT01831817|141752883|SUPERIORITY_OR_OTHER||Mean change difference|0.38||||0.0028|TWO_SIDED|95.0|0.13|0.63|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is second named treatment - first named treatment that a negative difference implies the mean of the first named treatment is larger than that of the second named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||0.63|0.13|0.0028
71123563|NCT01831817|141752883|SUPERIORITY_OR_OTHER||Mean change difference|0.39||||0.0022|TWO_SIDED|95.0|0.14|0.63|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is Second named treatment - first named treatment that a negative difference implies the mean of the first named treatment is larger than that of the second named treatment|Principal null hypothesis to be tested was- H0: The change from baseline waas the same for both treatments in all pairwise comparisons||0.63|0.14|0.0022
71123564|NCT01831817|141752883|SUPERIORITY_OR_OTHER||Mean change difference|-0.01||||0.9606|TWO_SIDED|95.0|-0.25|0.24|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is Second named treatment - first named treatment that a negative difference implies the mean of the first named treatment is larger than that of the second named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||0.24|-0.25|0.9606
71123565|NCT01831817|141752884|SUPERIORITY_OR_OTHER||Mean change difference|0.04||||0.803|TWO_SIDED|95.0|-0.3|0.38|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is First named treatment - second named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||0.38|-0.30|0.8030
71123566|NCT01831817|141752884|SUPERIORITY_OR_OTHER||Mean change difference|-0.82|||<|0.0001|TWO_SIDED|95.0|-1.16|-0.48|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is First named treatment - second named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||-0.48|-1.16|<0.0001
71123567|NCT01831817|141752884|SUPERIORITY_OR_OTHER||Mean change difference|-0.86|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.53|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is First named treatment - second named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||-0.53|-1.20|<0.0001
71123568|NCT01831817|141752884|SUPERIORITY_OR_OTHER||Mean change difference|0.86|||<|0.0001|TWO_SIDED|95.0|0.53|1.19|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is Second named treatment - first named treatment that a negative difference implies the mean of the first named treatment is larger than that of the second named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||1.19|0.53|<0.0001
71123569|NCT01831817|141752884|SUPERIORITY_OR_OTHER||Mean change difference|0.91|||<|0.0001|TWO_SIDED|95.0|0.58|1.23|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is Second named treatment - first named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||1.23|0.58|<0.0001
71085755|NCT03527277|141677107|SUPERIORITY||Mean Difference (Net)|-1.5||||0.46|TWO_SIDED|95.0|-5.7|2.6|||ANCOVA|Effect of group on change in outcome with adjustment for BMI, Outcome at baseline and gender||||2.6|-5.7|0.46
71085756|NCT03527277|141677108|SUPERIORITY||Mean Difference (Net)|-0.1||||0.97|TWO_SIDED|95.0|-3.1|3.0|||ANCOVA|Effect of group on change with adjustment for gender and outcome and BMI at baseline.||||3.0|-3.1|0.97
71085757|NCT03527277|141677109|SUPERIORITY||Mean Difference (Net)|-0.7||||0.73|TWO_SIDED|95.0|-4.8|3.4|||ANCOVA|Effect of group with adjustment for gender and outcome and BMI at baseline.||||3.4|-4.8|0.73
70944941|NCT01917006|141390478|SUPERIORITY||Least square mean difference|0.12||||0.377||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 4||||0.377
70944942|NCT01917006|141390478|SUPERIORITY||Least square mean difference|0.17||||0.321||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 4||||0.321
70944943|NCT01917006|141390478|SUPERIORITY||Least square mean difference|0.4||||0.149||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 4||||0.149
70944944|NCT01917006|141390478|SUPERIORITY||Least square mean difference|0.35||||0.215||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 6||||0.215
70856748|NCT00420641|141199978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63||||0.5057|TWO_SIDED|90.0|0.2|1.98|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 1.||1.98|0.20|0.5057
70944945|NCT01917006|141390478|SUPERIORITY||Least square mean difference|0.47||||0.126||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 6||||0.126
70856749|NCT00420641|141199978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.8633|TWO_SIDED|90.0|0.38|3.3|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 1.||3.30|0.38|0.8633
71085758|NCT03527277|141677110|SUPERIORITY||Mean Difference (Net)|1.0||||0.54|TWO_SIDED|95.0|-2.2|4.2|||ANCOVA|Effect of group change with adjustment for gender and BMI and outcome at baseline.||||4.2|-2.2|0.54
71085759|NCT03527277|141677111|SUPERIORITY||Mean Difference (Net)|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.34|-0.49|||ANCOVA|Effect of group with adjustment for gender and BMI and outcome at baseline.||||-0.49|-1.34|<0.0001
71085760|NCT03527277|141677112|SUPERIORITY||Mean Difference (Net)|-0.86|||<|0.0001|TWO_SIDED|95.0|-1.19|-0.53|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||-0.53|-1.19|<0.0001
71085761|NCT03527277|141677113|SUPERIORITY||Mean Difference (Net)|-0.38||||0.18|TWO_SIDED|95.0|-0.94|0.18|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||0.18|-0.94|0.18
71085762|NCT03527277|141677114|SUPERIORITY||Mean Difference (Net)|0.2||||0.49|TWO_SIDED|95.0|-0.38|0.77|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||0.77|-0.38|0.49
71085763|NCT03527277|141677115|SUPERIORITY||Mean Difference (Net)|-1.8||||0.66|TWO_SIDED|95.0|-10.1|6.5|||ANCOVA|Effect of group on change with adjustment of gender and BMI and outcome at baseline.||||6.5|-10.1|0.66
71085764|NCT03527277|141677116|SUPERIORITY||Mean Difference (Net)|-0.06||||0.78|TWO_SIDED|95.0|-0.06|0.35|||ANCOVA|Effect of group on change with adjustment for gender and outcome and BMI at baseline.||||0.35|-0.06|0.78
71085765|NCT03527277|141677117|SUPERIORITY||Mean Difference (Net)|0.03||||0.91|TWO_SIDED|95.0|-0.58|0.64|||ANCOVA|Effect of group on change with adjustment for gender and outcome and BMI at baseline.||||0.64|-0.58|0.91
71085766|NCT03527277|141677120|SUPERIORITY||Mean Difference (Net)|-7.9||||0.11|TWO_SIDED|95.0|-17.6|1.8|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||1.8|-17.6|0.11
70944946|NCT01917006|141390478|SUPERIORITY||Least square mean difference|-0.28||||0.774||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 6||||0.774
71085767|NCT03527277|141677121|SUPERIORITY||Mean Difference (Net)|23340.0||||0.0032|TWO_SIDED|95.0|8284.0|38396.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||38396|8284|0.0032
71085768|NCT03527277|141677122|SUPERIORITY||Mean Difference (Net)|5558.0||||0.0003|TWO_SIDED|95.0|2680.0|8437.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||8437|2680|0.0003
71085769|NCT03527277|141677123|SUPERIORITY||Mean Difference (Net)|3824.0||||0.0012|TWO_SIDED|95.0|1611.0|6036.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline||||6036|1611|0.0012
71085770|NCT03527277|141677124|SUPERIORITY||Mean Difference (Net)|19522.0||||0.0023|TWO_SIDED|95.0|7353.0|31691.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||31691|7353|0.0023
71085771|NCT03527277|141677125|SUPERIORITY||Mean Difference (Net)|21881.0||||0.0001|TWO_SIDED|95.0|11307.0|32455.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||32455|11307|0.0001
71085772|NCT03527277|141677126|SUPERIORITY||Mean Difference (Net)|9666.0||||0.0002|TWO_SIDED|95.0|4808.0|14524.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||14524|4808|0.0002
70856750|NCT00420641|141199978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.8428|TWO_SIDED|90.0|0.55|2.16|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 2.||2.16|0.55|0.8428
71123570|NCT01831817|141752884|SUPERIORITY_OR_OTHER||Mean change difference|-0.04||||0.7872|TWO_SIDED|95.0|-0.37|0.28|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is Second named treatment - first named treatment that a negative difference implies the mean of the first named treatment is larger than that of the second named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||0.28|-0.37|0.7872
71123571|NCT01831817|141752885|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.9642|TWO_SIDED|95.0|0.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||0.00|0.00|0.9642
71123572|NCT01831817|141752885|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.0016|TWO_SIDED|95.0|0.0|5.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||5.00|0.00|0.0016
71123573|NCT01831817|141752885|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.01|TWO_SIDED|95.0|0.0|5.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||5.00|0.00|0.0100
71123574|NCT01831817|141752885|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.002|TWO_SIDED|95.0|0.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the second named treatment|||0.00|0.00|0.0020
71123575|NCT01831817|141752885|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.0122|TWO_SIDED|95.0|0.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the second named treatment|||0.00|0.00|0.0122
71123576|NCT01831817|141752885|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.7138|TWO_SIDED|95.0|0.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||0.00|0.00|0.7138
71123577|NCT01831817|141752886|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.9834|TWO_SIDED|95.0|-5.0|5.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||5.00|-5.00|0.9834
71123578|NCT01831817|141752886|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|5.0||||0.0001|TWO_SIDED|95.0|0.0|15.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||15.00|0.00|0.0001
71123579|NCT01831817|141752886|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|2.5||||0.0003|TWO_SIDED|95.0|0.0|15.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||15.00|0.00|0.0003
71123580|NCT01831817|141752886|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|-5.0|||<|0.0001|TWO_SIDED|95.0|-10.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the second named treatment|||0.00|-10.00|<0.0001
71123581|NCT01831817|141752886|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|-5.0||||0.0002|TWO_SIDED|95.0|-10.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the second named treatment|||0.00|-10.00|0.0002
71123582|NCT01831817|141752886|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.2894|TWO_SIDED|95.0|0.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||0.00|0.00|0.2894
71123583|NCT01831817|141752887|SUPERIORITY_OR_OTHER||Mean change difference|-0.24||||0.5555|TWO_SIDED|95.0|-1.03|0.56|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||0.56|-1.03|0.5555
71123584|NCT01831817|141752887|SUPERIORITY_OR_OTHER||Mean change difference|-0.06||||0.8769|TWO_SIDED|95.0|-0.86|0.73|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||0.73|-0.86|0.8769
71123585|NCT01831817|141752887|SUPERIORITY_OR_OTHER||Mean change difference|-0.76||||0.0562|TWO_SIDED|95.0|-1.55|0.02|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||0.02|-1.55|0.0562
71123586|NCT01831817|141752887|SUPERIORITY_OR_OTHER||Mean change difference|-0.18||||0.6562|TWO_SIDED|95.0|-0.95|0.6|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||0.60|-0.95|0.6562
71123587|NCT01831817|141752887|SUPERIORITY_OR_OTHER||Mean change difference|0.53||||0.1788|TWO_SIDED|95.0|-0.24|1.3|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||1.30|-0.24|0.1788
71123588|NCT01831817|141752887|SUPERIORITY_OR_OTHER||Mean change difference|-0.7||||0.0734|TWO_SIDED|95.0|-1.47|0.07|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||0.07|-1.47|0.0734
71123589|NCT01831817|141752888|SUPERIORITY_OR_OTHER||Mean change difference|0.19||||0.6727|TWO_SIDED|95.0|-0.71|1.1|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||1.10|-0.71|0.6727
71123590|NCT01831817|141752888|SUPERIORITY_OR_OTHER||Mean change difference|-1.24||||0.0072|TWO_SIDED|95.0|-2.14|-0.34|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||-0.34|-2.14|0.0072
71123591|NCT01831817|141752888|SUPERIORITY_OR_OTHER||Mean change difference|-1.27||||0.0056|TWO_SIDED|95.0|-2.16|-0.38|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||-0.38|-2.16|0.0056
70856751|NCT00420641|141199978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.3416|TWO_SIDED|90.0|0.76|2.84|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 2.||2.84|0.76|0.3416
70856752|NCT00420641|141199978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.3287|TWO_SIDED|90.0|0.4|1.26|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 3.||1.26|0.40|0.3287
70856753|NCT00420641|141199978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.2112|TWO_SIDED|90.0|0.88|2.57|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 3.||2.57|0.88|0.2112
70944947|NCT01917006|141390478|SUPERIORITY||Least square mean difference|0.01||||0.495||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 6||||0.495
71085773|NCT03527277|141677127|SUPERIORITY||Mean Difference (Net)|3413.0||||0.0011|TWO_SIDED|95.0|1456.0|5370.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||5370|1456|0.0011
71085774|NCT03527277|141677128|SUPERIORITY||Mean Difference (Net)|11.6||||0.59|TWO_SIDED|95.0|-32.0|55.1|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||55.1|-32.0|0.59
71085775|NCT03527277|141677129|SUPERIORITY||Mean Difference (Net)|79.0||||0.028|TWO_SIDED|95.0|9.8|148.6|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||148.6|9.8|0.028
71085776|NCT03527277|141677131|SUPERIORITY||Mean Difference (Net)|-0.8||||0.17|TWO_SIDED|95.0|-1.94|0.35|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||0.35|-1.94|0.17
71085777|NCT03527277|141677132|SUPERIORITY||Mean Difference (Net)|0.54||||0.65|TWO_SIDED|95.0|-1.9|3.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||3.0|-1.9|0.65
71085778|NCT03527277|141677133|SUPERIORITY||Mean Difference (Net)|0.04||||0.88|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|Effect of group on change with adjustment for gender and outcome at baseline.||||0.6|-0.5|0.88
71085779|NCT03527277|141677134|SUPERIORITY||Mean Difference (Net)|0.6||||0.81|TWO_SIDED|95.0|-4.4|5.7|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||5.7|-4.4|0.81
71085780|NCT03527277|141677135|SUPERIORITY||Mean Difference (Net)|-0.7||||0.69|TWO_SIDED|95.0|-4.4|2.9|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||2.9|-4.4|0.69
71085781|NCT03527277|141677136|SUPERIORITY||Mean Difference (Net)|-0.4||||0.1|TWO_SIDED|95.0|-1.0|0.1|||ANCOVA|Effect of group on change with adjustment for gender and outcome at baseline.||||0.1|-1.0|0.10
71085782|NCT04155463|141677137|OTHER||Median Percent Change|-18.4||||0.17|TWO_SIDED||||||Wilcoxon signed rank test|Two-tailed test for paired data|This calculation shows the median percent change in urinary glyphosate concentrations going from the conventional diet to organic diet for all participants. Interquartile range for this was -37.4 to 29.8.|Based on previous pesticide research, we calculated a sample size of 40 participants to provide a power of 0.80 at a 0.05 significance level in a two-sided test. We assumed a standard deviation of 0.5 µg/L.||||0.17
71123592|NCT01831817|141752888|SUPERIORITY_OR_OTHER||Mean change diference|1.43||||0.0016|TWO_SIDED|95.0|0.56|2.31|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||2.31|0.56|0.0016
71123593|NCT01831817|141752888|SUPERIORITY_OR_OTHER||Mean change difference|1.46||||0.0011|TWO_SIDED|95.0|0.59|2.33|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||2.33|0.59|0.0011
71123594|NCT01831817|141752888|SUPERIORITY_OR_OTHER||Mean change difference|-0.03||||0.9413|TWO_SIDED|95.0|-0.9|0.84|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||0.84|-0.90|0.9413
71085783|NCT04155463|141677137|OTHER||Median Percent Change|-24.2||||0.06|TWO_SIDED||||||Wilcoxon signed rank test|Two-tailed test for paired data|This calculation shows the median percent change in urinary glyphosate concentrations going from the conventional diet to organic diet for far-field participants. Interquartile range for this was -37.4 to -8.8.|||||0.06
71085784|NCT04155463|141677137|OTHER||Median Percent Change|1.4||||0.83|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-tailed test for paired data|This calculation shows the median percent change in urinary glyphosate concentrations going from the conventional diet to organic diet for near-field participants. Interquartile range for this was -41.9 to 43.0.|||||0.83
71085785|NCT01063855|141677171|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.69|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|0.837|2.542||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate.|ANCOVA|ANCOVA model included treatment, PDE5I stratum, baseline Average IELT stratum, and region, as cofactors and baseline Average IELT as a covariate.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm minus PDE5I + Placebo arm difference.|Null Hypothesis: No difference at Week 12 last postbaseline observations carried forward (LPOCF) Alternative Hypothesis:- Difference at Week 12 LPOCF \>0.||2.542|0.837|<0.001
71085786|NCT01063855|141677172|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.6||||0.001|TWO_SIDED|95.0|4.9|22.3||A hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type 1 error rate.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test, controlling for type of PDE5I stratum, baseline average IELT stratum, and region.|Risk Difference (RD) = PDE5I + Dapoxetine arm - PDE5I + placebo arm.|Null hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF). Alternative hypothesis: Difference at Week 12 LPOCF \> 0.||22.3|4.9|0.001
71085787|NCT01063855|141677173|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.2||||0.013|TWO_SIDED|95.0|1.1|17.2||A hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type 1 error rate.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel (CMH) test, controlling for type of PDE5I stratum, baseline average IELT stratum, and region.|Risk Difference (RD) = PDE5I + Dapoxetine arm - PDE5I + Placebo arm.|Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF).||17.2|1.1|0.013
70944948|NCT01917006|141390478|SUPERIORITY||Least square mean difference|0.0||||0.495||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 6||||0.495
70944949|NCT01917006|141390478|SUPERIORITY||Least square mean difference|0.23||||0.274||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 6||||0.274
70856754|NCT00420641|141199978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.44||||0.0134|TWO_SIDED|90.0|0.26|0.76|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 4.||0.76|0.26|0.0134
70856755|NCT00420641|141199978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.3412|TWO_SIDED|90.0|0.81|2.17|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 4.||2.17|0.81|0.3412
70944950|NCT01917006|141390478|SUPERIORITY||Least square mean difference|0.22||||0.308||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 8||||0.308
71085788|NCT01063855|141677174|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.78||||0.002|TWO_SIDED|95.0|1.204|2.619||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error.|Regression, Logistic|Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.|Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF) Alternative Hypothesis: PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12 LPOCF.||2.619|1.204|0.002
71123595|NCT05065190|141752896|OTHER||Adjusted difference|106.57|STANDARD_ERROR_OF_MEAN|76.84|||TWO_SIDED|95.0|-47.13|260.28|||||Adjusted difference between treatment groups was based on a random slope and intercept model with fixed effects for treatment, HRCT pattern, and baseline FVC \[mL\], and including treatment-by-time and baseline-by-time interactions.|||260.28|-47.13|
70944951|NCT01917006|141390478|SUPERIORITY||Least square mean difference|0.34||||0.205||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 8||||0.205
71123596|NCT03320330|141752909|OTHER|Recommended Phase 2 dose of pepinemab (VX15/2503), administered to children with recurrent or refractory solid tumors (Part A), was determined by the rolling-6 design.|Recommended Phase 2 dose|20.0|||||TWO_SIDED||||||||Recommended Phase 2 dose of pepinemab (VX15/2503) is 20 mg/kg.|||||
70856756|NCT00420641|141199978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.8434|TWO_SIDED|90.0|0.58|1.54|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 5.||1.54|0.58|0.8434
70856757|NCT00420641|141199978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.0819|TWO_SIDED|90.0|1.03|2.63|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 5.||2.63|1.03|0.0819
71123597|NCT02936284|141752925|SUPERIORITY||Mean Difference (Net)|0.196||||0.016|TWO_SIDED||||||Mixed Models Analysis|mixed effect regression model including covariates: child sex, child birth weight, breastfeeding duration, percent class attendance and covid grouping|difference between music and play group change|||||0.016
71123598|NCT02936284|141752926|SUPERIORITY||Mean Difference (Net)|29.9||||0.7|TWO_SIDED||||||Mixed Models Analysis||music group vs. play group baseline to 24 months|mixed effect regression analysis, unstructured covariance, no covariates. Reporting group x time interaction||||0.70
71123599|NCT02936284|141752927|SUPERIORITY||Mean Difference (Net)|0.073||||0.54|TWO_SIDED||||||Mixed Models Analysis||increase in weight for length z-score for music group|mixed-effect regression analysis with covariates: child sex, birth weight, breastfeeding duration, percent class attendance and covid categories||||0.540
71123600|NCT03859739|141752931|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a LDA model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-0.79|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8558 and placebo ≤ -1.4 copies/mL was 2.44 %.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK-8558 and placebo is ≥ 1.4 log10 copies/mL.||||
71123601|NCT03859739|141752931|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a LDA model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-0.97|||||||||||||PP of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8558 and placebo ≤ -1.4 copies/mL was 7.60%.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK-8558 and placebo is ≥ 1.4 log10 copies/mL.||||
71123602|NCT03859739|141752931|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a LDA model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-1.58|||||||||||||PP of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8558 and placebo ≤ -1.4 copies/mL was 74.99%.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK-8558 and placebo is ≥ 1.4 log10 copies/mL.||||
71085789|NCT01063855|141677175|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63||||0.007|TWO_SIDED|95.0|1.108|2.394||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate.|Regression, Logistic|Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.|Null Hypothesis: No difference at Week 12 last postbaseline observation carrried forward (LPOCF) Alternative Hypothesis:- PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12 LPOCF.||2.394|1.108|0.007
71085790|NCT01063855|141677176|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.42|||<|0.001|TWO_SIDED|95.0|1.642|3.568||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate|Regression, Logistic|Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.|Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF) Alternative Hypothesis:- PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12.||3.568|1.642|<0.001
71123603|NCT03859739|141752931|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a LDA model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-1.78|||||||||||||PP of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8558 and placebo ≤ -1.4 copies/mL was 87.41%.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK-8558 and placebo is ≥ 1.4 log10 copies/mL.||||
71123604|NCT03859739|141752939|OTHER||Standard Error (SE)|0.146|||||||||||||PP that the true C168hr in plasma MK-8558 is ≥ 9.0 μM was 0.25%.|The posterior probability (PP) that the true GM C168hr is ≥ 9.0 μM was calculated using a non-informative (Jeffrey's) prior under an assumption of normality of log C168hr.||||
71123605|NCT03859739|141752939|OTHER||SE|0.146|||||||||||||PP that the true C168hr in plasma MK-8558 is ≥ 9.0 μM was 65.41%.|The PP that the true GM C168hr is ≥ 9.0 μM was calculated using a non-informative (Jeffrey's) prior under an assumption of normality of log C168hr.||||
71123606|NCT03859739|141752939|OTHER||SE|0.133|||||||||||||PP that the true C168hr in plasma MK-8558 is ≥ 9.0 μM was 99.99%.|The PP that the true GM C168hr is ≥ 9.0 μM was calculated using a non-informative (Jeffrey's) prior under an assumption of normality of log C168hr.||||
71123607|NCT03859739|141752939|OTHER||SE|0.163|||||||||||||PP that the true C168hr in plasma MK-8558 is ≥ 9.0 μM was 99.98%.|The PP that the true GM C168hr is ≥ 9.0 μM was calculated using a non-informative (Jeffrey's) prior under an assumption of normality of log C168hr.||||
71123608|NCT01300351|141752997|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.078|TWO_SIDED|95.0|0.54|1.03||With a sample size of 220 randomised patients and 150 progression events, if treatment effect is consistent between ethnicities/the study populations, there is an 89% chance the HR \<1.|Log Rank|||The results of this study would be considered to be consistent with that of the CONFIRM study if the hazard ratio (HR) point estimate for the treatment comparison was \<1 (ie, it favoured fulvestrant 500 mg), without the requirement for the benefit of fulvestrant 500 mg to be statistically significant.||1.03|0.54|0.078
71123609|NCT01300351|141752998|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.107|TWO_SIDED|95.0|0.93|2.24|||Regression, Logistic|||||2.24|0.93|0.107
71123610|NCT01300351|141752999|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.023|TWO_SIDED|95.0|1.04|1.8|||Regression, Logistic|||||1.80|1.04|0.023
71123611|NCT00673881|141753024|SUPERIORITY_OR_OTHER|||||||0.0042||95.0|||||t-test, 2 sided|||||||0.0042
71123612|NCT00673881|141753025|SUPERIORITY_OR_OTHER|||||||0.0002|||||||t-test, 2 sided|||Comparison baseline to end-of-treatment||||0.0002
71123613|NCT00673881|141753026|SUPERIORITY_OR_OTHER||||||NS|0|||||||t-test, 2 sided|||Comparison from baseline to end-of-treatment||||NS
71123614|NCT00673881|141753034|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
71123615|NCT00689793|141753037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|2.5||0.69|TWO_SIDED|95.0|0.0|10.0||Significant level of treatment effect was set at p\<0.05|Regression, Linear|Level of fatigue at four weeks:dependant variable. Group allocation and level of fatigue at baseline: independant variables.||The null hypothesis was that there was no difference in fatigue VAS scores between the treatment and placebo groups at 4 weeks||10|0|0.69
71123616|NCT00689793|141753038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|6.5|<|0.05||95.0|0.0|10.0|||Regression, Linear|Hemoglobin value at four weeks : dependant variable. Group allocation and hemoglobin value at baseline : independant variables.||||10|0|<0.05
71123617|NCT00689793|141753039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.0|STANDARD_DEVIATION|8.0|<|0.05|TWO_SIDED|95.0|0.0|30.0|||Regression, Linear|Ferritin level at 4 weeks : dependant variable. Group allocation and ferritin level at baseline: independant variables.||||30|0|<0.05
70856758|NCT00420641|141199978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.2832|TWO_SIDED|90.0|0.44|1.19|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 6.||1.19|0.44|0.2832
70856759|NCT00420641|141199978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.47||||0.0016|TWO_SIDED|90.0|1.54|3.97|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 6.||3.97|1.54|0.0016
70856760|NCT00420641|141199978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.9727|TWO_SIDED|90.0|0.6|1.63|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 8.||1.63|0.60|0.9727
70856761|NCT00420641|141199978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.57||||0.001|TWO_SIDED|90.0|1.6|4.13|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 8.||4.13|1.60|0.0010
70856762|NCT00420641|141199978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.8312|TWO_SIDED|90.0|0.64|1.8|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 10.||1.80|0.64|0.8312
70856763|NCT00420641|141199978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.06||||0.0002|TWO_SIDED|90.0|1.86|5.02|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 10.||5.02|1.86|0.0002
70856764|NCT00420641|141199978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58||||0.553|TWO_SIDED|90.0|0.13|2.6|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 1.||2.60|0.13|0.5530
70856765|NCT00420641|141199978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.978|TWO_SIDED|90.0|0.28|3.41|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 1.||3.41|0.28|0.9780
70856766|NCT00420641|141199978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.8312|TWO_SIDED|90.0|0.43|3.03|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 2.||3.03|0.43|0.8312
70856767|NCT00420641|141199978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.09||||0.1881|TWO_SIDED|90.0|0.83|5.25|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 2.||5.25|0.83|0.1881
70856768|NCT00420641|141199978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.6384|TWO_SIDED|90.0|0.39|1.69|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 3.||1.69|0.39|0.6384
70856769|NCT00420641|141199978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.216|TWO_SIDED|90.0|0.84|3.37|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 3.||3.37|0.84|0.2160
71123618|NCT00689793|141753040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|3.0||0.05|TWO_SIDED|95.0|0.0|6.0|||Regression, Linear|Aerobic capacity at 4 weeks : dependant variables. Group allocation and aerobic capacity at baseline : independant variable.||||6|0|0.05
71123619|NCT03968159|141753046|SUPERIORITY||LSM difference|-0.9|STANDARD_ERROR_OF_MEAN|0.82||0.2956|TWO_SIDED|95.0|-2.5|0.8|||Mixed-effects model for repeated measure|||||0.8|-2.5|0.2956
71123620|NCT05260333|141753057|OTHER||correlation coefficient|0.81||||0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.0001
71123621|NCT02827500|141753079|SUPERIORITY||Odds Ratio, log|5.19||||0.002|TWO_SIDED|95.0|1.88|14.33|||Regression, Logistic|||||14.33|1.88|0.002
71123622|NCT02827500|141753080|SUPERIORITY|||||||0.011|||||||Regression, Linear|||||||0.011
71123623|NCT02827500|141753081|SUPERIORITY|||||||0.011|||||||Regression, Linear|||The null hypothesis tested was that there is no difference in change in heart rate between the treatment arms.||||0.011
71123624|NCT02827500|141753082|SUPERIORITY|||||||0.054||||||The apriori threshold for statistical significance is alpha=0.05.|Chi-squared, Corrected|The p-value is obtained using the F-test (combination of Chi-Squared tests) due to multiple imputation.||The null hypothesis tested was that there is no difference between the treatment arms in the proportion of patients with heart rate \< 70 BPM.||||0.054
71123625|NCT02827500|141753083|SUPERIORITY|||||||0.717|||||||Regression, Linear|||||||0.717
71123626|NCT02827500|141753084|SUPERIORITY|||||||0.784|||||||Regression, Linear|||||||0.784
71123627|NCT01541917|141753088|SUPERIORITY_OR_OTHER||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|-0.06|-0.02|||Multilevel growth model|Adjusted for baseline values|The parameter represents the average monthly change on the outcome variable since group procedures were initiated.|Multilevel growth model evaluating average change over time (regardless of group) on the outcome variable||-.02|-.06|<.001
71123628|NCT01541917|141753088|SUPERIORITY_OR_OTHER||Slope|-0.014|STANDARD_ERROR_OF_MEAN|0.021||0.51|TWO_SIDED|95.0|-0.055|0.027|||Multilevel growth model||The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.||.027|-.055|.51
71123629|NCT01541917|141753089|SUPERIORITY_OR_OTHER||Slope|0.37|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|0.27|0.46|||Multilevel growth model|Adjusted for baseline values.|The parameter represents the average monthly change on the outcome variable since before group procedures were started.|Multilevel growth model evaluating average change over time on the outcome variable||.46|.27|<.001
70856770|NCT00420641|141199978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.0259|TWO_SIDED|90.0|0.2|0.79|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 4.||0.79|0.20|0.0259
70856771|NCT00420641|141199978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.3959|TWO_SIDED|90.0|0.39|1.35|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 4.||1.35|0.39|0.3959
70856772|NCT00420641|141199978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.3857|TWO_SIDED|90.0|0.39|1.34|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 5.||1.34|0.39|0.3857
71123630|NCT01541917|141753089|SUPERIORITY_OR_OTHER||Slope|0.053|STANDARD_ERROR_OF_MEAN|0.101||0.59|TWO_SIDED|95.0|-0.144|0.252|||Multilevel growth model|Adjusted for baseline values on the outcome variable|The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.||.252|-.144|.59
71085791|NCT01063855|141677177|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33|||>|0.05|TWO_SIDED|95.0|0.897|1.965||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate.|Regression, Logistic|Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.|Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF) Alternative Hypothesis:- PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12 LPOCF.||1.965|0.897|>0.05
70856773|NCT00420641|141199978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.3126|TWO_SIDED|90.0|0.8|2.52|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 5.||2.52|0.80|0.3126
71085792|NCT01063855|141677178|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21|||<|0.001|TWO_SIDED|95.0|1.425|3.423||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate.|Regression, Logistic|Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.|Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF) Alternative Hypothesis:- PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12.||3.423|1.425|<0.001
71085793|NCT02035553|141677223|SUPERIORITY||Diff in MMRM LSM|-1.84||||0.0451|TWO_SIDED|95.0|-3.64|-0.04|||Mixed Models Analysis|||||-0.04|-3.64|0.0451
71085794|NCT02619617|141677224|OTHER|1.5mg SOM230 s.c. vs. Placebo s.c.|Odds Ratio (OR)|1.308||||0.698|TWO_SIDED|90.0|0.419|4.082|||Regression, Logistic|||||4.082|0.419|0.698
71085795|NCT02619617|141677225|OTHER|1.5mg SOM230 s.c. vs. Placebo s.c.|Odds Ratio (OR)|2.033||||0.385|TWO_SIDED|90.0|0.53|7.79|||Regression, Logistic|||||7.790|0.530|0.385
71085796|NCT01854697|141677228|NON_INFERIORITY_OR_EQUIVALENCE|The primary endpoint assessment comparison was made within each of the 2 HCV genotypes (GT1a and GT1b). Within HCV GT1a, the 3-DAA + RBV and TPV/PR arms were compared. Within HCV GT1b, the 3-DAA and TPV/PR arms were compared. The test treatment arm was considered noninferior to the TPV/PR arm in the respective HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.|Difference|14.7|||||TWO_SIDED|95.0|1.3|28.2|||||Difference (95% CI) from TPV/PR within GT1a. Calculated using the normal approximation to the binomial distribution.|||28.2|1.3|
71085797|NCT01854697|141677228|NON_INFERIORITY_OR_EQUIVALENCE|The primary endpoint assessment comparison was made within each of the 2 HCV genotypes (GT1a and GT1b). Within HCV GT1a, the 3-DAA + RBV and TPV/PR arms were compared. Within HCV GT1b, the 3-DAA and TPV/PR arms were compared. The test treatment arm was considered noninferior to the TPV/PR arm in the respective HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.|Difference|19.5|||||TWO_SIDED|95.0|6.4|32.6|||||Difference (95% CI) from TPV/PR within GT1b. Calculated using the normal approximation to the binomial distribution.|||32.6|6.4|
71085798|NCT01854697|141677229|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.13|STANDARD_ERROR_OF_MEAN|2.28||0.351|TWO_SIDED|95.0|-2.39|6.65|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.||||6.65|-2.39|0.351
71085799|NCT01854697|141677229|SUPERIORITY_OR_OTHER||Least Squares Mean of Difference|5.83|STANDARD_ERROR_OF_MEAN|1.84||0.002|TWO_SIDED|95.0|2.19|9.47|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.||||9.47|2.19|0.002
71085800|NCT01854697|141677229|SUPERIORITY_OR_OTHER||Least Squares Mean of Difference|5.28|STANDARD_ERROR_OF_MEAN|1.65||0.002|TWO_SIDED|95.0|2.01|8.54|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.||||8.54|2.01|0.002
71085801|NCT01854697|141677230|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.08|STANDARD_ERROR_OF_MEAN|1.69|<|0.001|TWO_SIDED|95.0|2.72|9.44|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.||||9.44|2.72|<0.001
71085802|NCT01854697|141677230|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.2|STANDARD_ERROR_OF_MEAN|1.34|<|0.001|TWO_SIDED|95.0|3.55|8.85|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.||||8.85|3.55|<0.001
71085803|NCT01854697|141677230|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.86|STANDARD_ERROR_OF_MEAN|1.27|<|0.001|TWO_SIDED|95.0|4.36|9.37|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.||||9.37|4.36|<0.001
71085804|NCT01854697|141677231|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.2||||0.021|TWO_SIDED|95.0|1.4|38.0|||Regression, Logistic|Logistic regression model with treatment arm, baseline log10 HCV RNA level, and interleukin 28B (IL28B) genotype (CC versus non-CC) as predictors.||||38.0|1.4|0.021
71085805|NCT01854697|141677231|NON_INFERIORITY_OR_EQUIVALENCE|The test treatment arm was considered noninferior to the TPV/PR arm in the GT1b HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.|Difference|20.8|||||TWO_SIDED|95.0|7.9|33.6|||||Difference (95% CI) from TPV/PR within GT1b. Calculated using the normal approximation to the binomial distribution.|||33.6|7.9|
71085806|NCT01854697|141677231|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|28.2||||0.002|TWO_SIDED|95.0|3.3|241.1|||Regression, Logistic|Calculated using logistic regression model with treatment arm, baseline log10 HCV RNA level, and IL28B genotype (CC versus non-CC) as predictors.||||241.1|3.3|0.002
71085807|NCT01854697|141677231|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratum-adjusted Cochran-Mantel-Haenszel after adjusting for IL28B genotype (CC or non-CC).||||||0.005
71085808|NCT01854697|141677234|NON_INFERIORITY_OR_EQUIVALENCE|The test treatment arm was considered noninferior to the TPV/PR arm in the GT1a HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.|Difference|13.3|||||TWO_SIDED|95.0|-0.4|27.0|||||Difference (95% CI) from TPV/PR within GT1a. Calculated using the normal approximation to the binomial distribution.|||27.0|-0.4|
71123631|NCT01541917|141753090|SUPERIORITY_OR_OTHER||Slope|0.12|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|0.1|0.14|||Multilevel growth model|Adjusted for baseline values|The parameter represents the average monthly change on the outcome variable since before group procedures were started|Multilevel growth model evaluating average change over time on the outcome variable||.14|.10|<.001
71123632|NCT01541917|141753090|SUPERIORITY_OR_OTHER||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.63|TWO_SIDED|95.0|-0.05|0.03|||Multilevel growth model|Adjusted for baseline values on the outcome variable|The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.||.03|-.05|.63
71123633|NCT01541917|141753091|SUPERIORITY_OR_OTHER||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.02|TWO_SIDED|95.0|-0.18|-0.01|||Multilevel growth model|Adjusted for baseline values|The parameter represents the average monthly change on the outcome variable since before group procedures were started.|Multilevel growth model evaluating average change over time on the outcome variable||-.01|-.18|.02
71123634|NCT01541917|141753091|SUPERIORITY_OR_OTHER||Slope|-0.009|STANDARD_ERROR_OF_MEAN|0.084||0.91|TWO_SIDED|95.0|-0.174|0.155|||Multilevel growth model|Adjusted for baseline values on the outcome variable|The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.||.155|-.174|.91
71123635|NCT01541917|141753092|SUPERIORITY_OR_OTHER||Slope|0.0316|STANDARD_ERROR_OF_MEAN|0.004|<|0.001|TWO_SIDED|95.0|0.02|0.04|||Multilevel growth model|Adjusted for baseline values.|The parameter represents the average monthly change on the outcome variable since before group procedures were started|Multilevel growth model evaluating average change over time on the outcome variable||.04|.02|<.001
71123636|NCT01541917|141753092|SUPERIORITY_OR_OTHER||Slope|-0.004|STANDARD_ERROR_OF_MEAN|0.008||0.67|TWO_SIDED|95.0|-0.02|0.013|||Multilevel growth model|Adjusted for baseline values on the outcome variable|The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.||.013|-.02|.67
71123637|NCT01541917|141753093|SUPERIORITY_OR_OTHER||Slope|-0.002|STANDARD_ERROR_OF_MEAN|0.004||0.58|TWO_SIDED|95.0|-0.01|0.01|||Multilevel growth model|Adjusted for baseline values|The parameter represents the average monthly change on the outcome variable since before group procedures were started.|Multilevel growth model evaluating average change over time on the outcome variable||.01|-.01|.58
71123638|NCT01541917|141753093|SUPERIORITY_OR_OTHER||Slope|0.005|STANDARD_ERROR_OF_MEAN|0.007||0.49|TWO_SIDED|95.0|-0.009|0.018|||Multilevel growth model|Adjusted for baseline values on the outcome variable|The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.||.018|-.009|.49
71123639|NCT01014455|141753097|SUPERIORITY_OR_OTHER|||||||0.672||95.0|||||t-test, 2 sided|||||||0.672
71123640|NCT04728594|141753117|SUPERIORITY||Odds Ratio (OR)|2.11|||<|0.001|TWO_SIDED|95.0|1.65|2.69||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with delayed contact as the reference group.||2.69|1.65|<.001
71123641|NCT04728594|141753117|SUPERIORITY||Odds Ratio (OR)|2.26|||<|0.001|TWO_SIDED|95.0|1.77|2.87||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with delayed contact as the reference group.||2.87|1.77|<.001
71123642|NCT04728594|141753117|SUPERIORITY||Odds Ratio (OR)|1.07|||<|0.001|TWO_SIDED|95.0|0.88|1.3||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with delayed contact as the reference group.||1.30|0.88|<.001
70856774|NCT00420641|141199978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61||||0.1182|TWO_SIDED|90.0|0.36|1.03|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 6.||1.03|0.36|0.1182
71123643|NCT01378429|141753123|NON_INFERIORITY_OR_EQUIVALENCE|35 subjects per arm would have ≥90% power to demonstrate that the upper bound of a two-sided 95% confidence interval (equivalent to the upper bound of a one-sided 97.5% confidence interval) of the difference of placebo minus ciclesonide nasal aerosol would be less than 20% of the baseline value of 175 mcg•h/dL or a noninferiority limit of 35 mcg•h/dL assuming a SD of 40 and a one-sided α of 0.025. A total of 40 subjects will be randomly assigned to ensure 35 subjects complete the study per arm.|LS Mean Difference|7.6|||||TWO_SIDED|95.0|-7.4|22.6||\<0.025 for a one-sided test.|ANCOVA||Difference is calculated as Placebo - Ciclesonide.|35 subjects per arm would have ≥90% power to demonstrate that the upper bound of a two-sided 95% confidence interval (equivalent to the upper bound of a one-sided 97.5% confidence interval) of the difference of placebo minus ciclesonide nasal aerosol would be less than 20% of the baseline value of 175 mcg•h/dL or a noninferiority limit of 35 mcg•h/dL assuming a SD of 40 and a one-sided α of 0.025. A total of 40 subjects will be randomly assigned to ensure 35 subjects complete the study per arm.||22.6|-7.4|
71085809|NCT01854697|141677234|NON_INFERIORITY_OR_EQUIVALENCE|The test treatment arm was considered noninferior to the TPV/PR arm in the GT1b HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.|Difference|19.6|||||TWO_SIDED|95.0|6.5|32.7|||||Difference (95% CI) from TPV/PR within GT1b. Calculated using the normal approximation to the binomial distribution.|||32.7|6.5|
71085810|NCT01854697|141677234|NON_INFERIORITY_OR_EQUIVALENCE|The test treatment arm was considered noninferior to the TPV/PR arm in the GT1b HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.|Difference|19.5|||||TWO_SIDED|95.0|6.4|32.6|||||Difference (95% CI) from TPV/PR within GT1b. Calculated using the normal approximation to the binomial distribution.|||32.6|6.4|
71085811|NCT02185417|141677242|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.45|TWO_SIDED|95.0|0.94|1.16|||Log Rank|||Primary analyses were performed with the use of unadjusted log-rank tests that were stratified according to VA health care system.||1.16|0.94|0.45
71085812|NCT00974311|141677250|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.53|0.75|||Log Rank|Stratified by baseline Eastern Cooperative Oncology Group (ECOG) performance status and mean Brief Pain Inventory - Short Form score (Question #3).|Hazard Ratio and 95% confidence interval are from Cox regression model.|||0.75|0.53|<0.0001
71085813|NCT00974311|141677251|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||<|0.0001|TWO_SIDED|95.0|0.35|0.47|||Log Rank|Stratified by baseline ECOG performance status and mean Brief Pain Inventory - Short Form score (Question #3).|Hazard Ratio and 95% confidence interval are from Cox regression model.|||0.47|0.35|<0.0001
71085814|NCT00974311|141677252|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.0001|TWO_SIDED|95.0|0.566|0.835|||Log Rank|Stratified by baseline ECOG performance status and mean Brief Pain Inventory - Short Form score (Question #3).|Hazard Ratio and 95% confidence interval are from Cox regression model.|||0.835|0.566|0.0001
71085815|NCT00974311|141677253|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|24.9|||<|0.0001|TWO_SIDED|95.0|18.8|30.9|||Cochran-Mantel-Haenszel|Stratified by baseline ECOG performance status and mean Brief Pain Inventory - Short Form score (Question #3).|Confidence Interval based on standard normal approximation.|||30.9|18.8|<0.0001
71085816|NCT00974311|141677254|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.248|||<|0.0001|TWO_SIDED|95.0|0.204|0.303||Stratified by baseline ECOG performance status and mean Brief Pain Inventory - Short Form score (Question #3).|Log Rank||Hazard Ratio and 95% confidence interval are from Cox regression model.|||0.303|0.204|<0.0001
71085817|NCT00974311|141677255|SUPERIORITY_OR_OTHER||Difference in Rate of Pain Palliation|38.2||||0.0079|TWO_SIDED|95.0|19.4|57.0|||Cochran-Mantel-Haenszel|Stratified by baseline Eastern Cooperative Oncology Group performance status (0-1 vs. 2).|Confidence Interval based on standard normal approximation.|||57.0|19.4|0.0079
71085818|NCT05556148|141677268|OTHER||Mean Difference (Final Values)|-1.54||||0.2968|TWO_SIDED|95.0|-4.44|1.37|||Student's paired t-test|||Change from Baseline at Day 1||1.37|-4.44|0.2968
71085819|NCT05556148|141677268|OTHER||Mean Difference (Final Values)|-15.36|||<|0.0001|TWO_SIDED|95.0|-19.77|-10.95|||Student's paired t-test|||Change from Baseline at Day 2||-10.95|-19.77|<.0001
71085820|NCT05556148|141677268|OTHER||Mean Difference (Final Values)|-27.27|||<|0.0001|TWO_SIDED|95.0|-33.06|-21.49|||Student's paired t-test|||Change from Baseline at Day 3||-21.49|-33.06|<.0001
71085821|NCT05556148|141677268|OTHER||Mean Difference (Final Values)|-35.05|||<|0.0001|TWO_SIDED|95.0|-41.69|-28.41|||Student's paired t-test|||Change from Baseline at Day 4||-28.41|-41.69|<.0001
71085822|NCT05556148|141677268|OTHER||Mean Difference (Final Values)|-38.49|||<|0.0001|TWO_SIDED|95.0|-45.87|-31.11|||Student's paired t-test|||Change from Baseline at Day 5||-31.11|-45.87|<.0001
71085823|NCT05556148|141677268|OTHER||Mean Difference (Final Values)|-39.67|||<|0.0001|TWO_SIDED|95.0|-48.46|-30.88|||Student's paired t-test|||Change from Baseline at Day 6||-30.88|-48.46|<.0001
71085824|NCT05556148|141677268|OTHER||Mean Difference (Final Values)|-52.6|||<|0.0001|TWO_SIDED|95.0|-63.69|-41.51|||Student's paired t-test|||Change from Baseline at Day 7||-41.51|-63.69|<.0001
71085825|NCT05556148|141677269|OTHER||Mean Difference (Final Values)|0.29||||0.7112|TWO_SIDED|95.0|-1.27|1.86|||Student's paired t-test|||Change from Baseline at Day 1||1.86|-1.27|0.7112
71085826|NCT05556148|141677269|OTHER||Mean Difference (Final Values)|-6.21|||<|0.0001|TWO_SIDED|95.0|-8.51|-3.92|||Student's paired t-test|||Change from Baseline at Day 2||-3.92|-8.51|<.0001
71085827|NCT05556148|141677269|OTHER||Mean Difference (Final Values)|-12.11|||<|0.0001|TWO_SIDED|95.0|-15.0|-9.22|||Student's paired t-test|||Change from Baseline at Day 3||-9.22|-15.00|<.0001
71085828|NCT05556148|141677269|OTHER||Mean Difference (Final Values)|-15.98|||<|0.0001|TWO_SIDED|95.0|-19.24|-12.71|||Student's paired t-test|||Change from Baseline at Day 4||-12.71|-19.24|<.0001
71085829|NCT05556148|141677269|OTHER||Mean Difference (Final Values)|-19.44|||<|0.0001|TWO_SIDED|95.0|-23.29|-15.59|||Student's paired t-test|||Change from Baseline at Day 5||-15.59|-23.29|<.0001
71085830|NCT05556148|141677269|OTHER||Mean Difference (Final Values)|-19.36|||<|0.0001|TWO_SIDED|95.0|-24.03|-14.69|||Student's paired t-test|||Change from Baseline at Day 6||-14.69|-24.03|<.0001
71085831|NCT05556148|141677269|OTHER||Mean Difference (Final Values)|-25.4|||<|0.0001|TWO_SIDED|95.0|-31.87|-18.93|||Student's paired t-test|||Change from Baseline at Day 7||-18.93|-31.87|<.0001
71085832|NCT05556148|141677270|OTHER||Mean Difference (Final Values)|-1.83||||0.0481|TWO_SIDED|95.0|-3.64|-0.02|||Student's paired t-test|||Change from Baseline at Day 1||-0.02|-3.64|0.0481
71085833|NCT05556148|141677270|OTHER||Mean Difference (Final Values)|-9.14|||<|0.0001|TWO_SIDED|95.0|-11.74|-6.55|||Student's paired t-test|||Change from Baseline at Day 2||-6.55|-11.74|<.0001
71085834|NCT05556148|141677270|OTHER||Mean Difference (Final Values)|-15.16|||<|0.0001|TWO_SIDED|95.0|-18.44|-11.88|||Student's paired t-test|||Change from Baseline at Day 3||-11.88|-18.44|<.0001
71085835|NCT05556148|141677270|OTHER||Mean Difference (Final Values)|-19.07|||<|0.0001|TWO_SIDED|95.0|-22.84|-15.3|||Student's paired t-test|||Change from Baseline at Day 4||-15.30|-22.84|<.0001
71085836|NCT05556148|141677270|OTHER||Mean Difference (Final Values)|-19.05|||<|0.0001|TWO_SIDED|95.0|-23.35|-14.75|||Student's paired t-test|||Change from Baseline at Day 5||-14.75|-23.35|<.0001
71123644|NCT01018095|141753140|NON_INFERIORITY_OR_EQUIVALENCE|Continuous variables were assessed for normality, and tested accordingly. When appropriate, continuous variables were categorized using clinically relevant cut-points. Categorical variables were compared using the Chi-square test. The measure of association at TOC was calculated as a relative risk with 95% confidence interval.|Risk Ratio (RR)|0.5|STANDARD_ERROR_OF_MEAN|0.191||0.045|TWO_SIDED|95.0|0.25|1.0|||Relative risk|The measure of association at TOC and 3 months was calculated as a relative risk with 95% confidence interval.||It was initially estimated that a total of 380 participants (190 per arm) would be required, with 90% power and a significance level of 5%, to establish equivalency between the two treatment arms.31 Enrollment rates were lower than estimated and only 270 participants (135 per arm) were enrolled.||1.00|0.25|.045
70944952|NCT01917006|141390478|SUPERIORITY||Least square mean difference|-0.39||||0.849||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 8||||0.849
70944953|NCT01917006|141390478|SUPERIORITY||Least square mean difference|-0.07||||0.571||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 8||||0.571
70944954|NCT01917006|141390478|SUPERIORITY||Least square mean difference|-0.09||||0.592||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 8||||0.592
71123645|NCT01018095|141753140|NON_INFERIORITY_OR_EQUIVALENCE|It was initially estimated that a total of 380 participants (190 per arm) would be required, with 90% power and a significance level of 5%, to establish equivalency between the two treatment arms.|Risk Ratio (RR)|0.46|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED|95.0|0.21|0.98||Continuous variables were assessed for normality, and tested accordingly. When appropriate, continuous variables were categorized using clinically relevant cut-points. Categorical variables were compared using the Chi-square test.|Chi-squared|||||0.98|0.21|<0.05
71123646|NCT01018095|141753141|NON_INFERIORITY_OR_EQUIVALENCE|Continuous variables were assessed for normality, and tested accordingly. When appropriate, continuous variables were categorized using clinically relevant cut-points. Categorical variables were compared using the Chi-square test. The measure of association at 3 months was calculated as a relative risk with 95% confidence interval.|Risk Ratio (RR)|0.46|STANDARD_ERROR_OF_MEAN|0.196|=|0.03|TWO_SIDED|95.0|0.21|0.98|||Relative risk|The measure of association at TOC and 3 months was calculated as a relative risk with 95% confidence interval.||It was initially estimated that a total of 380 participants (190 per arm) would be required, with 90% power and a significance level of 5%, to establish equivalency between the two treatment arms.31 Enrollment rates were lower than estimated and only 270 participants (135 per arm) were enrolled.||0.98|.21|=0.03
71123647|NCT01751776|141753199|SUPERIORITY_OR_OTHER_LEGACY||Slope|2.0506|STANDARD_ERROR_OF_MEAN|0.4242|||TWO_SIDED|95.0|1.1843|2.9168|||||Dose proportionality was explored using a regression model. Based on the estimate for the slope parameter, a 2-sided 95% CI was computed. Perfect dose proportionality would correspond to a slope of 1. PK endpoints on the log-transformed scale.|Dose proportionality for Cmax was explored after the first adminstration of BI 65564 on Day 1.||2.9168|1.1843|
71123648|NCT01751776|141753199|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.4227|STANDARD_ERROR_OF_MEAN|0.1644|||TWO_SIDED|95.0|1.0869|1.7584|||||Dose proportionality was explored using a regression model. Based on the estimate for the slope parameter, a 2-sided 95% CI was computed. Perfect dose proportionality would correspond to a slope of 1. PK endpoints on the log-transformed scale.|Dose proportionality for Cmax was explored after the last (fourth) adminstration of BI 65564 on Day 22.||1.7584|1.0869|
70856775|NCT00420641|141199978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1||||0.0125|TWO_SIDED|90.0|1.29|3.43|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 6.||3.43|1.29|0.0125
70944955|NCT01917006|141390478|SUPERIORITY||Least square mean difference|0.16||||0.34||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 8||||0.340
70944956|NCT01917006|141390478|SUPERIORITY||Least square mean difference|0.16||||0.36||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 10||||0.360
70944957|NCT01917006|141390478|SUPERIORITY||Least square mean difference|0.35||||0.192||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 10||||0.192
70944958|NCT01917006|141390478|SUPERIORITY||Least square mean difference|-0.37||||0.843||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 10||||0.843
71085837|NCT05556148|141677270|OTHER||Mean Difference (Final Values)|-20.31|||<|0.0001|TWO_SIDED|95.0|-25.7|-14.92|||Student's paired t-test|||Change from Baseline at Day 6||-14.92|-25.70|<.0001
70856776|NCT00420641|141199978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.2147|TWO_SIDED|90.0|0.42|1.13|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 8.||1.13|0.42|0.2147
70856777|NCT00420641|141199978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.0783|TWO_SIDED|90.0|1.03|2.69|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 8.||2.69|1.03|0.0783
71085838|NCT05556148|141677270|OTHER||Mean Difference (Final Values)|-27.2|||<|0.0001|TWO_SIDED|95.0|-32.48|-21.92|||Student's paired t-test|||Change from Baseline at Day 7||-21.92|-32.48|<.0001
71085839|NCT05556148|141677271|OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-0.31|0.31|||Student's paired t-test|||Change from Baseline at Day 1||0.31|-0.31|1.0000
71085840|NCT05556148|141677271|OTHER||Mean Difference (Final Values)|-0.63||||0.0003|TWO_SIDED|95.0|-0.97|-0.3|||Student's paired t-test|||Change from Baseline at Day 2||-0.30|-0.97|0.0003
70856778|NCT00420641|141199978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.9067||90.0|0.57|1.64|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 10.||1.64|0.57|0.9067
71085841|NCT05556148|141677271|OTHER||Mean Difference (Final Values)|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.7|||Student's paired t-test|||Change from Baseline at Day 3||-0.70|-1.50|<.0001
71085842|NCT05556148|141677271|OTHER||Mean Difference (Final Values)|-1.72|||<|0.0001|TWO_SIDED|95.0|-2.2|-1.24|||Student's paired t-test|||Change from Baseline at Day 4||-1.24|-2.20|<.0001
71085843|NCT05556148|141677271|OTHER||Mean Difference (Final Values)|-1.75|||<|0.0001|TWO_SIDED|95.0|-2.33|-1.16|||Student's paired t-test|||Change from Baseline at Day 5||-1.16|-2.33|<.0001
71085844|NCT05556148|141677271|OTHER||Mean Difference (Final Values)|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.51|-1.28|||Student's paired t-test|||Change from Baseline at Day 6||-1.28|-2.51|<.0001
71085845|NCT05556148|141677271|OTHER||Mean Difference (Final Values)|-2.47|||<|0.0001|TWO_SIDED|95.0|-3.29|-1.64|||Student's paired t-test|||Change from Baseline at Day 7||-1.64|-3.29|<.0001
71085846|NCT05556148|141677272|OTHER||Mean Difference (Final Values)|-0.39||||0.0023|TWO_SIDED|95.0|-0.64|-0.14|||Student's paired t-test|||Change from Baseline at Day 1||-0.14|-0.64|0.0023
71085847|NCT05556148|141677272|OTHER||Mean Difference (Final Values)|-1.47|||<|0.0001|TWO_SIDED|95.0|-1.82|-1.12|||Student's paired t-test|||Change from Baseline at Day 2||-1.12|-1.82|<.0001
71123649|NCT01751776|141753200|SUPERIORITY_OR_OTHER_LEGACY||Slope|2.0091|STANDARD_ERROR_OF_MEAN|0.1706|||TWO_SIDED|95.0|1.6607|2.3575|||||Dose proportionality was explored using a regression model. Based on the estimate for the slope parameter, a 2-sided 95% CI was computed. Perfect dose proportionality would correspond to a slope of 1. PK endpoints on the log-transformed scale.|Dose proportionality for AUC 0-infinity was explored after the last adminstration of BI 65564 on Day 22.||2.3575|1.6607|
71123650|NCT01751776|141753201|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.4225|STANDARD_ERROR_OF_MEAN|0.164|||TWO_SIDED|95.0|1.0876|1.7574|||||Dose proportionality was explored using a regression model. Based on the estimate for the slope parameter, a 2-sided 95% CI was computed. Perfect dose proportionality would correspond to a slope of 1. PK endpoints on the log-transformed scale.|Dose proportionality for AUCtau was explored after the last administration of BI 65564 on Day 22.||1.7574|1.0876|
71123651|NCT01751776|141753203|OTHER||Mean Difference (Net)|22.7|||||||||||||Mean Difference in percentage|Observed difference of ACR20 response for BI 120mg - Placebo||||
71123652|NCT01751776|141753203|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Mean Difference (Net)|33.0|||||||||||||Mean Difference in percentage|Expected difference of ACR20 response for BI 120mg - Placebo||||
71123653|NCT01751776|141753203|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|99.9||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 0%||||
71123654|NCT01751776|141753203|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|99.7||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 5%||||
71123655|NCT01751776|141753203|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|98.7||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 10%||||
71123656|NCT01751776|141753203|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|96.0||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 15%||||
71123657|NCT01751776|141753203|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|90.0||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 20%||||
70856779|NCT00420641|141199978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.0328|TWO_SIDED|90.0|1.15|2.92|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 10.||2.92|1.15|0.0328
70856780|NCT00420641|141199979|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.6928|TWO_SIDED|90.0|0.44|3.76|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 1.||3.76|0.44|0.6928
70856781|NCT00420641|141199979|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.86||||0.3039|TWO_SIDED|90.0|0.69|5.01|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 1.||5.01|0.69|0.3039
71123658|NCT01751776|141753203|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|79.0||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 25%||||
71123659|NCT01751776|141753203|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|62.5||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 30%||||
71123660|NCT01751776|141753203|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|42.9||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 35%||||
71123661|NCT01751776|141753203|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|24.5||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 40%||||
71123662|NCT01751776|141753203|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|11.1||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 45%||||
71123663|NCT01751776|141753204|SUPERIORITY_OR_OTHER_LEGACY||Risk difference, unadjusted|18.2||||0.0754|TWO_SIDED|95.0|-6.6|38.6|||One-sided exact test (see description)|One-sided exact test for superiority testing|The exact 95% confidence interval was calculated by Clopper and Pearson.|unadjusted||38.6|-6.6|0.0754
71123664|NCT01751776|141753204|SUPERIORITY_OR_OTHER_LEGACY||risk difference, adjusted|20.0|||||TWO_SIDED|95.0|-4.6|39.0|||||The 95 % confidence interval was determined by root method to determine the cumulative distribution function. Adjusted for treatment, region and anti-Tumour Necrosis Factor (TNF)|adjusted||39.0|-4.6|
71123665|NCT01751776|141753205|SUPERIORITY_OR_OTHER_LEGACY||risk difference, unadjusted|4.5||||0.3938|TWO_SIDED|95.0|-18.4|22.3|||one-sided exact test (see description)|one-sided exact test for superiority testing.|The exact 95% confidence interval was calculated by Clopper and Pearson.|unadjusted||22.3|-18.4|0.3938
71123666|NCT01751776|141753205|SUPERIORITY_OR_OTHER_LEGACY||risk difference, adjusted|4.0|||||TWO_SIDED|95.0|-18.9|21.1|||||The 95 % confidence interval was determined by root method to determine the cumulative distribution function. Adjusted for treatment, region and anti-TNF history|adjusted||21.1|-18.9|
71123667|NCT01751776|141753208|SUPERIORITY_OR_OTHER_LEGACY||Risk difference|6.8|||||TWO_SIDED|95.0|-17.6|32.7|||||The exact 95% confidence interval was calculated by Clopper and Pearson.|unadjusted||32.7|-17.6|
71123668|NCT01751776|141753208|SUPERIORITY_OR_OTHER_LEGACY||risk difference, adjusted|8.9|||||TWO_SIDED|95.0|-15.9|34.2|||||The 95 % confidence interval was determined by root method to determine the cumulative distribution function. Adjusted for treatment, region and anti-TNF history|adjusted||34.2|-15.9|
71123669|NCT01751776|141753209|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean|-0.14|STANDARD_ERROR_OF_MEAN|0.266|||TWO_SIDED|95.0|-0.67|0.39|||||difference calculated as BI 655064 120mg minus placebo. The ANCOVA model was used. In this model the mean was adjusted for region, anti-TNF history and baseline DAS28-CRP.|difference calculated as BI 655064 120mg minus placebo.||0.39|-0.67|
71123670|NCT01122108|141753214|SUPERIORITY_OR_OTHER||||||<|0.05||||||If a sequence was not found to be statistically significant, then that term was removed from final model. Normality of residuals was investigated for each outcome variable using the Shapiro-Wilk test.|repeated measures analysis of variance|Sensitivity analyses were run to evaluate possible product by sequence interactions||"The BASA scale was previously developed to effectively compare differing Bile acid sequestrant forumulations. The BASA scale should differentiate subject acceptability of Colesevelam HCl 3.75 vs Cholestyramine 12g based upon the sum of ratings for taste, texture, appearance and mixability.~If normality hypothesis was rejected, then further inspection of the distribution utilizing normal quantile-quantile and kernel density plots was employed."||||<0.05
71123671|NCT04075409|141753224|OTHER||LS means ratio|1.426|||||TWO_SIDED|90.0|1.112|1.83|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% Confidence Intervals (CIs) were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.830|1.112|
70856782|NCT00420641|141199979|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.1938|TWO_SIDED|90.0|0.89|2.7|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 2.||2.70|0.89|0.1938
71123672|NCT04075409|141753224|OTHER||LS means ratio|1.234|||||TWO_SIDED|90.0|0.9619|1.584|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.584|0.9619|
71123673|NCT04075409|141753224|OTHER||LS means ratio|1.156|||||TWO_SIDED|90.0|0.9008|1.483|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.483|0.9008|
71123674|NCT04075409|141753225|OTHER||LS means ratio|2.122|||||TWO_SIDED|90.0|1.706|2.638|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||2.638|1.706|
71123675|NCT04075409|141753225|OTHER||LS means ratio|1.289|||||TWO_SIDED|90.0|1.037|1.603|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.603|1.037|
71123676|NCT04075409|141753225|OTHER||LS means ratio|1.646|||||TWO_SIDED|90.0|1.323|2.046|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||2.046|1.323|
71123677|NCT04075409|141753226|OTHER||LS means ratio|2.124|||||TWO_SIDED|90.0|1.709|2.639|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||2.639|1.709|
71123678|NCT04075409|141753226|OTHER||LS means ratio|1.291|||||TWO_SIDED|90.0|1.039|1.604|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.604|1.039|
70856783|NCT00420641|141199979|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.06|TWO_SIDED|90.0|1.08|3.16|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 2.||3.16|1.08|0.0600
70856784|NCT00420641|141199979|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8989|TWO_SIDED|90.0|0.61|1.53|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 3.||1.53|0.61|0.8989
70856785|NCT00420641|141199979|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.95||||0.0136|TWO_SIDED|90.0|1.25|3.05|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 3.||3.05|1.25|0.0136
70856786|NCT00420641|141199979|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.3099|TWO_SIDED|90.0|0.5|1.18|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 4.||1.18|0.50|0.3099
71123679|NCT04075409|141753226|OTHER||LS means ratio|1.645|||||TWO_SIDED|90.0|1.324|2.044|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||2.044|1.324|
71123680|NCT04075409|141753229|OTHER||LS means ratio|1.089|||||TWO_SIDED|90.0|0.8859|1.339|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.339|0.8859|
70856787|NCT00420641|141199979|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.1137|TWO_SIDED|90.0|0.98|2.27|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 4.||2.27|0.98|0.1137
70856788|NCT00420641|141199979|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.8682||90.0|0.67|1.64|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 5.||1.64|0.67|0.8682
70856789|NCT00420641|141199979|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.56||||0.0006|TWO_SIDED|90.0|1.63|4.03|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 5.||4.03|1.63|0.0006
70856790|NCT00420641|141199979|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.8992|TWO_SIDED|90.0|0.62|1.51|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 6.||1.51|0.62|0.8992
70944959|NCT01917006|141390478|SUPERIORITY||Least square mean difference|-0.07||||0.572||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 10||||0.572
70944960|NCT01917006|141390478|SUPERIORITY||Least square mean difference|-0.12||||0.628||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 10||||0.628
70944961|NCT01917006|141390478|SUPERIORITY||Least square mean difference|0.12||||0.38||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 10||||0.380
70944962|NCT03954223|141390522|SUPERIORITY|||||||0.4|TWO_SIDED|95.0|||||ANOVA|||||||0.4
70944963|NCT03954223|141390523|SUPERIORITY||Median Difference (Final Values)|-7.0||||0.2|TWO_SIDED|95.0|||||Regression, Linear|Mixed-effects generalized linear model of the glycemic profile change extracted from CGM data.||||||0.2
70944964|NCT03927690|141390528|SUPERIORITY||Difference (Test vs Reference)|-2.6||||0.887|TWO_SIDED|90.0|-6.2|1.0|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 2||1.0|-6.2|0.887
71085848|NCT05556148|141677272|OTHER||Mean Difference (Final Values)|-1.99|||<|0.0001|TWO_SIDED|95.0|-2.4|-1.58|||Student's paired t-test|||Change from Baseline at Day 3||-1.58|-2.40|<.0001
70944965|NCT03927690|141390528|SUPERIORITY||Difference (Test vs Reference)|0.3||||0.431|TWO_SIDED|90.0|-2.6|3.2|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 2||3.2|-2.6|0.431
70944966|NCT03927690|141390528|SUPERIORITY||Difference (Test vs Reference)|-1.0||||0.647|TWO_SIDED|90.0|-5.4|3.4|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 8||3.4|-5.4|0.647
70944967|NCT03927690|141390528|SUPERIORITY||Difference (Test vs Reference)|2.4||||0.13|TWO_SIDED|90.0|-1.1|6.0|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 8||6.0|-1.1|0.130
70944968|NCT03927690|141390528|SUPERIORITY||Difference (Test vs Reference)|-2.5||||0.818|TWO_SIDED|90.0|-6.9|2.0|||Mixed model repeated measures analysis||Comparison of model-based mean estimates|Day 15||2.0|-6.9|0.818
70944969|NCT03927690|141390528|SUPERIORITY||Difference (Test vs Reference)|0.3||||0.457|TWO_SIDED|90.0|-3.6|4.1|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 15||4.1|-3.6|0.457
71123681|NCT04075409|141753229|OTHER||LS means ratio|1.044|||||TWO_SIDED|90.0|0.8489|1.283|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.283|0.8489|
71123682|NCT04075409|141753229|OTHER||LS means ratio|1.044|||||TWO_SIDED|90.0|0.8489|1.283|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.283|0.8489|
70856791|NCT00420641|141199979|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.61||||0.0004|TWO_SIDED|90.0|1.67|4.09|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 6.||4.09|1.67|0.0004
70944970|NCT03927690|141390528|SUPERIORITY||Difference (Test vs Reference)|-3.1||||0.906|TWO_SIDED|90.0|-6.9|0.8|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 29||0.8|-6.9|0.906
70944971|NCT03927690|141390528|SUPERIORITY||Difference (Test vs Reference)|-0.4||||0.566|TWO_SIDED|90.0|-4.1|3.3|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 29||3.3|-4.1|0.566
70944972|NCT03927690|141390528|SUPERIORITY||Difference (Test vs Reference)|-1.3||||0.686|TWO_SIDED|90.0|-5.6|3.1|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 43||3.1|-5.6|0.686
70944973|NCT03927690|141390528|SUPERIORITY||Difference (Test vs Reference)|1.4||||0.28|TWO_SIDED|90.0|-2.5|5.2|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 43||5.2|-2.5|0.280
70944974|NCT03927690|141390528|SUPERIORITY||Difference (Test vs Reference)|-2.4||||0.849|TWO_SIDED|90.0|-6.3|1.4|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 57||1.4|-6.3|0.849
70944975|NCT03927690|141390528|SUPERIORITY||Difference (Test vs Reference)|1.5||||0.254|TWO_SIDED|90.0|-2.2|5.2|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 57||5.2|-2.2|0.254
70944976|NCT03927690|141390528|SUPERIORITY||Difference (Test vs Reference)|-2.7||||0.866|TWO_SIDED|90.0|-6.6|1.3|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 85||1.3|-6.6|0.866
71085849|NCT05556148|141677272|OTHER||Mean Difference (Final Values)|-2.43|||<|0.0001|TWO_SIDED|95.0|-2.86|-2.0|||Student's paired t-test|||Change from Baseline at Day 4||-2.00|-2.86|<.0001
71085850|NCT05556148|141677272|OTHER||Mean Difference (Final Values)|-3.0|||<|0.0001|TWO_SIDED|95.0|-3.51|-2.49|||Student's paired t-test|||Change from Baseline at Day 5||-2.49|-3.51|<.0001
71085851|NCT05556148|141677272|OTHER||Mean Difference (Final Values)|-2.77|||<|0.0001|TWO_SIDED|95.0|-3.36|-2.18|||Student's paired t-test|||Change from Baseline at Day 6||-2.18|-3.36|<.0001
71085852|NCT05556148|141677272|OTHER||Mean Difference (Final Values)|-3.33|||<|0.0001|TWO_SIDED|95.0|-4.1|-2.57|||Student's paired t-test|||Change from Baseline at Day 7||-2.57|-4.10|<.0001
71085853|NCT05556148|141677273|OTHER||Mean Difference (Final Values)|-0.11||||0.4495|TWO_SIDED|95.0|-0.4|0.18|||Student's paired t-test|||Change from Baseline at Day 1||0.18|-0.40|0.4495
71085854|NCT05556148|141677273|OTHER||Mean Difference (Final Values)|-0.87|||<|0.0001|TWO_SIDED|95.0|-1.19|-0.54|||Student's paired t-test|||Change from Baseline at Day 2||-0.54|-1.19|<.0001
71085855|NCT05556148|141677273|OTHER||Mean Difference (Final Values)|-1.21|||<|0.0001|TWO_SIDED|95.0|-1.59|-0.82|||Student's paired t-test|||Change from Baseline at Day 3||-0.82|-1.59|<.0001
71085856|NCT05556148|141677273|OTHER||Mean Difference (Final Values)|-1.59|||<|0.0001|TWO_SIDED|95.0|-2.05|-1.12|||Student's paired t-test|||Change from Baseline at Day 4||-1.12|-2.05|<.0001
71085857|NCT05556148|141677273|OTHER||Mean Difference (Final Values)|-1.86|||<|0.0001|TWO_SIDED|95.0|-2.4|-1.33|||Student's paired t-test|||Change from Baseline at Day 5||-1.33|-2.40|<.0001
71085858|NCT05556148|141677273|OTHER||Mean Difference (Final Values)|-1.85|||<|0.0001|TWO_SIDED|95.0|-2.45|-1.24|||Student's paired t-test|||Change from Baseline at Day 6||-1.24|-2.45|<.0001
71123683|NCT04075409|141753230|OTHER||LS means ratio|1.344|||||TWO_SIDED|90.0|1.092|1.653|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.653|1.092|
71123684|NCT04075409|141753230|OTHER||LS means ratio|0.9991|||||TWO_SIDED|90.0|0.812|1.229|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.229|0.8120|
71123685|NCT04075409|141753230|OTHER||LS means ratio|1.345|||||TWO_SIDED|90.0|1.093|1.655|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.655|1.093|
70856792|NCT00420641|141199979|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.28|TWO_SIDED|90.0|0.85|2.23|||Placebo versus GSK372475 in percentage o|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 8.||2.23|0.85|0.2800
70856793|NCT00420641|141199979|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.69||||0|TWO_SIDED|90.0|2.24|6.08|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 8.||6.08|2.24|0.0000
70856794|NCT00420641|141199979|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.86||||0.0507|TWO_SIDED|90.0|1.1|3.13|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 10.||3.13|1.10|0.0507
71085859|NCT05556148|141677273|OTHER||Mean Difference (Final Values)|-2.47|||<|0.0001|TWO_SIDED|95.0|-3.19|-1.75|||Student's paired t-test|||Change from Baseline at Day 7||-1.75|-3.19|<.0001
71085860|NCT05556148|141677274|OTHER||Mean Difference (Final Values)|0.11||||0.4758|TWO_SIDED|95.0|-0.2|0.42|||Student's paired t-test|||Change from Baseline at Day 1||0.42|-0.20|0.4758
71085861|NCT05556148|141677274|OTHER||Mean Difference (Final Values)|-0.61||||0.0016|TWO_SIDED|95.0|-0.99|-0.24|||Student's paired t-test|||Change from Baseline at Day 2||-0.24|-0.99|0.0016
71085862|NCT05556148|141677274|OTHER||Mean Difference (Final Values)|-1.23|||<|0.0001|TWO_SIDED|95.0|-1.67|-0.79|||Student's paired t-test|||Change from Baseline at Day 3||-0.79|-1.67|<.0001
71085863|NCT05556148|141677274|OTHER||Mean Difference (Final Values)|-1.67|||<|0.0001|TWO_SIDED|95.0|-2.18|-1.16|||Student's paired t-test|||Change from Baseline at Day 4||-1.16|-2.18|<.0001
70856795|NCT00420641|141199979|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.97||||0.0003|TWO_SIDED|90.0|1.81|4.88|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 10.||4.88|1.81|0.0003
70856796|NCT00420641|141199980|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8782|TWO_SIDED|90.0|0.62|1.5|||Regression, Logistic|||Placebo versus GSK372475 in percentage of participants Satisfied with Study Medication at Week 10.||1.50|0.62|0.8782
70856797|NCT00420641|141199980|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.45||||0.0011|TWO_SIDED|90.0|1.56|3.86|||Regression, Logistic|||Placebo versus Paroxetine in percentage of participants Satisfied with Study Medication at Week 10.||3.86|1.56|0.0011
70944977|NCT03927690|141390528|SUPERIORITY||Difference (Test vs Reference)|2.0||||0.198|TWO_SIDED|90.0|-1.9|5.8|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 85||5.8|-1.9|0.198
71085864|NCT05556148|141677274|OTHER||Mean Difference (Final Values)|-1.98|||<|0.0001|TWO_SIDED|95.0|-2.46|-1.51|||Student's paired t-test|||Change from Baseline at Day 5||-1.51|-2.46|<.0001
71085865|NCT05556148|141677274|OTHER||Mean Difference (Final Values)|-2.08|||<|0.0001|TWO_SIDED|95.0|-2.77|-1.39|||Student's paired t-test|||Change from Baseline at Day 6||-1.39|-2.77|<.0001
71085866|NCT05556148|141677274|OTHER||Mean Difference (Final Values)|-2.87|||<|0.0001|TWO_SIDED|95.0|-3.65|-2.08|||Student's paired t-test|||Change from Baseline at Day 7||-2.08|-3.65|<.0001
71085867|NCT05556148|141677275|OTHER||Mean Difference (Final Values)|-0.04||||0.8017|TWO_SIDED|95.0|-0.36|0.28|||Student's paired t-test|||Change from Baseline at Day 1||0.28|-0.36|0.8017
71085868|NCT05556148|141677275|OTHER||Mean Difference (Final Values)|-0.67||||0.0005|TWO_SIDED|95.0|-1.05|-0.3|||Student's paired t-test|||Change from Baseline at Day 2||-0.30|-1.05|0.0005
71085869|NCT05556148|141677275|OTHER||Mean Difference (Final Values)|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.69|-0.89|||Student's paired t-test|||Change from Baseline at Day 3||-0.89|-1.69|<.0001
71085870|NCT05556148|141677275|OTHER||Mean Difference (Final Values)|-1.41|||<|0.0001|TWO_SIDED|95.0|-1.86|-0.97|||Student's paired t-test|||Change from Baseline at Day 4||-0.97|-1.86|<.0001
71085871|NCT05556148|141677275|OTHER||Mean Difference (Final Values)|-1.98|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.47|||Student's paired t-test|||Change from Baseline at Day 5||-1.47|-2.50|<.0001
71123686|NCT01595581|141753248|OTHER|Mann-Whitney U test for continuous variables and Fisher exact test for categorical variables|Mean Difference (Net)|2.9|STANDARD_DEVIATION|1.5||0.35|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||"Power was estimated for change in lean mass of 3.0 plus or minus 1.5 kg in healthy men receiving testosterone. Using a significance level of 0.05 and a power of 0.80, a sample size of 6 participants per group was calculated.~This statistical analysis applies to lean mass in participants 6 weeks post operative."||||0.35
70944978|NCT03927690|141390534|SUPERIORITY||Ratio (Test vs Reference)|1.2||||0.998|TWO_SIDED|90.0|1.08|1.33|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 8||1.33|1.08|0.998
70944979|NCT03927690|141390534|SUPERIORITY||Ratio (Test vs Reference)|1.0||||0.527|TWO_SIDED|90.0|0.92|1.09|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 8||1.09|0.92|0.527
70944980|NCT03927690|141390534|SUPERIORITY||Ratio (Test vs Reference)|1.21||||0.999|TWO_SIDED|90.0|1.1|1.33|||Mixed model repeated measures analysis||Comparison of model-based mean estimates|Day 15||1.33|1.10|0.999
70944981|NCT03927690|141390534|SUPERIORITY||Ratio (Test vs Reference)|1.03||||0.716|TWO_SIDED|90.0|0.95|1.12|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 15||1.12|0.95|0.716
70944982|NCT03927690|141390534|SUPERIORITY||Ratio (Test vs Reference)|1.21||||1|TWO_SIDED|90.0|1.13|1.31|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 29||1.31|1.13|1.000
71085872|NCT05556148|141677275|OTHER||Mean Difference (Final Values)|-1.95|||<|0.0001|TWO_SIDED|95.0|-2.61|-1.29|||Student's paired t-test|||Change from Baseline at Day 6||-1.29|-2.61|<.0001
71085873|NCT05556148|141677275|OTHER||Mean Difference (Final Values)|-2.4|||<|0.0001|TWO_SIDED|95.0|-3.26|-1.54|||Student's paired t-test|||Change from Baseline at Day 7||-1.54|-3.26|<.0001
71085874|NCT05556148|141677276|OTHER||Mean Difference (Final Values)|0.03||||0.8311|TWO_SIDED|95.0|-0.25|0.31|||Student's paired t-test|||Change from Baseline at Day 1||0.31|-0.25|0.8311
70944983|NCT03927690|141390534|SUPERIORITY||Ratio (Test vs Reference)|0.98||||0.281|TWO_SIDED|90.0|0.91|1.05|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 29||1.05|0.91|0.281
70944984|NCT03927690|141390534|SUPERIORITY||Ratio (Test vs Reference)|1.32||||1|TWO_SIDED|90.0|1.2|1.46|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 43||1.46|1.20|1.000
70944985|NCT03927690|141390534|SUPERIORITY||Ratio (Test vs Reference)|0.96||||0.2|TWO_SIDED|90.0|0.88|1.04|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 43||1.04|0.88|0.200
70944986|NCT03927690|141390534|SUPERIORITY||Ratio (Test vs Reference)|1.18||||1|TWO_SIDED|90.0|1.09|1.28|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 57||1.28|1.09|1.000
70944987|NCT03927690|141390534|SUPERIORITY||Ratio (Test vs Reference)|0.94||||0.083|TWO_SIDED|90.0|0.87|1.01|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 57||1.01|0.87|0.083
70944988|NCT03927690|141390534|SUPERIORITY||Ratio(Test vs Reference)|1.26||||1|TWO_SIDED|90.0|1.14|1.38|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 85||1.38|1.14|1.000
70944989|NCT03927690|141390534|SUPERIORITY||Ratio(Test vs Reference)|0.96||||0.254|TWO_SIDED|90.0|0.88|1.06|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 85||1.06|0.88|0.254
70944990|NCT01850823|141390542|EQUIVALENCE|Equivalence based on Test/Reference Ratio and 90% confidence interval (as per OGD guidance)|Ratio Test/Reference LS Mean|114.723|||||TWO_SIDED|90.0|99.077|134.286||||||Conducted on Per Protocol Population||134.286|99.077|
70944991|NCT01850823|141390543|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||The superiority of treatment over the placebo will be concluded if the treatment's mean change from baseline is statistically significantly greater (p\<0.05, 2-sided) than that of the placebo in the ANCOVA based on the treatment and placebo results. The superiority of Test and Reference treatments over the placebo will be evaluated identically in a separate ANCOVA.||||<0.0001
71085875|NCT05556148|141677276|OTHER||Mean Difference (Final Values)|-0.41||||0.0313|TWO_SIDED|95.0|-0.78|-0.04|||Student's paired t-test|||Change from Baseline at Day 2||-0.04|-0.78|0.0313
71085876|NCT05556148|141677276|OTHER||Mean Difference (Final Values)|-0.84||||0.0003|TWO_SIDED|95.0|-1.28|-0.39|||Student's paired t-test|||Change from Baseline at Day 3||-0.39|-1.28|0.0003
71085877|NCT05556148|141677276|OTHER||Mean Difference (Final Values)|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.51|-0.59|||Student's paired t-test|||Change from Baseline at Day 4||-0.59|-1.51|<.0001
71085878|NCT05556148|141677276|OTHER||Mean Difference (Final Values)|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.74|-0.66|||Student's paired t-test|||Change from Baseline at Day 5||-0.66|-1.74|<.0001
71085879|NCT05556148|141677276|OTHER||Mean Difference (Final Values)|-1.05||||0.0018|TWO_SIDED|95.0|-1.69|-0.42|||Student's paired t-test|||Change from Baseline at Day 6||-0.42|-1.69|0.0018
71085880|NCT05556148|141677276|OTHER||Mean Difference (Final Values)|-1.27||||0.0041|TWO_SIDED|95.0|-2.1|-0.43|||Student's paired t-test|||Change from Baseline at Day 7||-0.43|-2.10|0.0041
71085881|NCT05556148|141677277|OTHER||Mean Difference (Final Values)|0.01||||0.938|TWO_SIDED|95.0|-0.25|0.27|||Student's paired t-test|||Change from Baseline at Day 1||0.27|-0.25|0.9380
71085882|NCT05556148|141677277|OTHER||Mean Difference (Final Values)|-0.37||||0.0416|TWO_SIDED|95.0|-0.72|-0.01|||Student's paired t-test|||Change from Baseline at Day 2||-0.01|-0.72|0.0416
71085883|NCT05556148|141677277|OTHER||Mean Difference (Final Values)|-0.96|||<|0.0001|TWO_SIDED|95.0|-1.29|-0.62|||Student's paired t-test|||Change from Baseline at Day 3||-0.62|-1.29|<.0001
71085884|NCT05556148|141677277|OTHER||Mean Difference (Final Values)|-1.18|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.76|||Student's paired t-test|||Change from Baseline at Day 4||-0.76|-1.60|<.0001
70944992|NCT01850823|141390543|SUPERIORITY|||||||0.0002|||||||ANCOVA|||The superiority of treatment over the placebo will be concluded if the treatment's mean change from baseline is statistically significantly greater (p\<0.05, 2-sided) than that of the placebo in the ANCOVA based on the treatment and placebo results. The superiority of Test and Reference treatments over the placebo will be evaluated identically in a separate ANCOVA.||||0.0002
70944993|NCT01751165|141390545|NON_INFERIORITY_OR_EQUIVALENCE|Non-nferiority criteria: The upper limit (UL) of the 97.5% confidence interval (CI) for the anti-gE ELISA geometric mean concentration (GMC) ratio (0,2-month schedule over 0,6-month schedule) at one month post-dose 2 had to be below 1.5.|Adjusted GMC ratio|1.16|||||TWO_SIDED|97.5|0.98|1.39|||ANCOVA|||To demonstrate the non-inferiority in terms of anti-gE humoral immune response one month post-dose 2 given according to a 0,6-month schedule compared to a 0,2-month schedule.||1.39|0.98|
71085885|NCT05556148|141677277|OTHER||Mean Difference (Final Values)|-1.76|||<|0.0001|TWO_SIDED|95.0|-2.25|-1.27|||Student's paired t-test|||Change from Baseline at Day 5||-1.27|-2.25|<.0001
71085886|NCT05556148|141677277|OTHER||Mean Difference (Final Values)|-1.69|||<|0.0001|TWO_SIDED|95.0|-2.33|-1.05|||Student's paired t-test|||Change from Baseline at Day 6||-1.05|-2.33|<.0001
71085887|NCT05556148|141677277|OTHER||Mean Difference (Final Values)|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.08|-1.52|||Student's paired t-test|||Change from Baseline at Day 7||-1.52|-3.08|<.0001
71085888|NCT05556148|141677278|OTHER||Mean Difference (Final Values)|0.04||||0.7821|TWO_SIDED|95.0|-0.25|0.33|||Student's paired t-test|||Change from Baseline at Day 1||0.33|-0.25|0.7821
71085889|NCT05556148|141677278|OTHER||Mean Difference (Final Values)|-0.77|||<|0.0001|TWO_SIDED|95.0|-1.14|-0.39|||Student's paired t-test|||Change from Baseline at Day 2||-0.39|-1.14|<.0001
71085890|NCT05556148|141677278|OTHER||Mean Difference (Final Values)|-1.62|||<|0.0001|TWO_SIDED|95.0|-2.05|-1.19|||Student's paired t-test|||Change from Baseline at Day 3||-1.19|-2.05|<.0001
71085891|NCT05556148|141677278|OTHER||Mean Difference (Final Values)|-2.29|||<|0.0001|TWO_SIDED|95.0|-2.73|-1.86|||Student's paired t-test|||Change from Baseline at Day 4||-1.86|-2.73|<.0001
71085892|NCT05556148|141677278|OTHER||Mean Difference (Final Values)|-2.46|||<|0.0001|TWO_SIDED|95.0|-2.98|-1.94|||Student's paired t-test|||Change from Baseline at Day 5||-1.94|-2.98|<.0001
71085893|NCT05556148|141677278|OTHER||Mean Difference (Final Values)|-2.64|||<|0.0001|TWO_SIDED|95.0|-3.36|-1.92|||Student's paired t-test|||Change from Baseline at Day 6||-1.92|-3.36|<.0001
71085894|NCT05556148|141677278|OTHER||Mean Difference (Final Values)|-3.2|||<|0.0001|TWO_SIDED|95.0|-4.19|-2.21|||Student's paired t-test|||Change from Baseline at Day 7||-2.21|-4.19|<.0001
71085895|NCT05556148|141677279|OTHER||Mean Difference (Final Values)|0.44||||0.0003|TWO_SIDED|95.0|0.21|0.68|||Student's paired t-test|||Change from Baseline at Day 1||0.68|0.21|0.0003
71085896|NCT05556148|141677279|OTHER||Mean Difference (Final Values)|-0.07||||0.646|TWO_SIDED|95.0|-0.38|0.24|||Student's paired t-test|||Change from Baseline at Day 2||0.24|-0.38|0.6460
71085897|NCT05556148|141677279|OTHER||Mean Difference (Final Values)|-0.59||||0.0021|TWO_SIDED|95.0|-0.95|-0.22|||Student's paired t-test|||Change from Baseline at Day 3||-0.22|-0.95|0.0021
71085898|NCT05556148|141677279|OTHER||Mean Difference (Final Values)|-0.83||||0.0002|TWO_SIDED|95.0|-1.25|-0.41|||Student's paired t-test|||Change from Baseline at Day 4||-0.41|-1.25|0.0002
71085899|NCT05556148|141677279|OTHER||Mean Difference (Final Values)|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.68|-0.73|||Student's paired t-test|||Change from Baseline at Day 5||-0.73|-1.68|<.0001
71085900|NCT05556148|141677279|OTHER||Mean Difference (Final Values)|-1.36||||0.0003|TWO_SIDED|95.0|-2.04|-0.68|||Student's paired t-test|||Change from Baseline at Day 6||-0.68|-2.04|0.0003
71085901|NCT05556148|141677279|OTHER||Mean Difference (Final Values)|-2.13|||<|0.0001|TWO_SIDED|95.0|-2.95|-1.32|||Student's paired t-test|||Change from Baseline at Day 7||-1.32|-2.95|<.0001
71085902|NCT05556148|141677280|OTHER||Mean Difference (Final Values)|0.2||||0.1074|TWO_SIDED|95.0|-0.04|0.45|||Student's paired t-test|||Change from Baseline at Day 1||0.45|-0.04|0.1074
71085903|NCT05556148|141677280|OTHER||Mean Difference (Final Values)|-0.35||||0.0364|TWO_SIDED|95.0|-0.67|-0.02|||Student's paired t-test|||Change from Baseline at Day 2||-0.02|-0.67|0.0364
71085904|NCT05556148|141677280|OTHER||Mean Difference (Final Values)|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.68|-0.91|||Student's paired t-test|||Change from Baseline at Day 3||-0.91|-1.68|<.0001
71085905|NCT05556148|141677280|OTHER||Mean Difference (Final Values)|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.25|-1.36|||Student's paired t-test|||Change from Baseline at Day 4||-1.36|-2.25|<.0001
71085906|NCT05556148|141677280|OTHER||Mean Difference (Final Values)|-2.24|||<|0.0001|TWO_SIDED|95.0|-2.78|-1.69|||Student's paired t-test|||Change from Baseline at Day 5||-1.69|-2.78|<.0001
71085907|NCT05556148|141677280|OTHER||Mean Difference (Final Values)|-2.08|||<|0.0001|TWO_SIDED|95.0|-2.7|-1.45|||Student's paired t-test|||Change from Baseline at Day 6||-1.45|-2.70|<.0001
71085908|NCT05556148|141677280|OTHER||Mean Difference (Final Values)|-2.97|||<|0.0001|TWO_SIDED|95.0|-3.84|-2.1|||Student's paired t-test|||Change from Baseline at Day 7||-2.10|-3.84|<.0001
71085909|NCT05556148|141677281|OTHER||Mean Difference (Final Values)|-1.88|||<|0.0001|TWO_SIDED|95.0|-2.33|-1.43|||Student's paired t-test|||Day 1||-1.43|-2.33|<.0001
71085910|NCT05556148|141677281|OTHER||Mean Difference (Final Values)|-2.45|||<|0.0001|TWO_SIDED|95.0|-2.9|-2.01|||Student's paired t-test|||Day 2||-2.01|-2.90|<.0001
71085911|NCT05556148|141677281|OTHER||Mean Difference (Final Values)|-2.9|||<|0.0001|TWO_SIDED|95.0|-3.41|-2.39|||Student's paired t-test|||Day 3||-2.39|-3.41|<.0001
70856798|NCT02815280|141199998|SUPERIORITY||Mean Difference (Final Values)|3.15|STANDARD_ERROR_OF_MEAN|1.12||0.0051|TWO_SIDED|95.0|0.95|5.35|||ANCOVA|||Change from baseline in inflammatory lesion count was analyzed using an analysis of covariance (ANCOVA) model, which included treatment, baseline inflammatory lesion count and pooled investigational site as a blocking factor.||5.35|0.95|0.0051
70856799|NCT02815280|141199999|SUPERIORITY|P-value is for the null hypothesis that the combined log (Risk Ratio) equals 0.|Risk ratio|1.88|STANDARD_ERROR_OF_MEAN|0.31||0.0424|TWO_SIDED|95.0|1.02|3.46|||Mantel Haenszel|||||3.46|1.02|0.0424
70856800|NCT02815280|141200000|SUPERIORITY||Mean Difference (Final Values)|12.84|STANDARD_ERROR_OF_MEAN|5.3||0.0155|TWO_SIDED|95.0|2.44|23.23||Percent change from baseline was analyzed using an ANCOVA model, which included treatment, baseline non-inflammatory lesion counts and pooled investigational site as a blocking factor. For the superiority comparison between FMX101 4% and vehicle.|ANCOVA|||||23.23|2.44|0.0155
70856801|NCT02815280|141200001|SUPERIORITY|Change from baseline in inflammatory lesion count for Week 6 was analyzed using an ANCOVA model, which included treatment, baseline inflammatory lesion counts and pooled investigational site as a blocking factor.|Mean Difference (Final Values)|3.89|STANDARD_ERROR_OF_MEAN|1.03||0.0001|TWO_SIDED|95.0|1.88|5.9|||ANCOVA|||||5.90|1.88|0.0001
70856802|NCT02815280|141200001|SUPERIORITY|Change from baseline in inflammatory lesion count for Week 9 was analyzed using an ANCOVA model, which included treatment, baseline inflammatory lesion counts and pooled investigational site as a blocking factor.|Mean Difference (Final Values)|3.78|STANDARD_ERROR_OF_MEAN|1.11||0.0007|TWO_SIDED|95.0|1.6|5.95|||ANCOVA|||||5.95|1.60|0.0007
70856803|NCT02815280|141200002|SUPERIORITY|P-value is for the null hypothesis that the combined log (Risk Ratio) equals 0. Percentage of participants achieving IGA treatment success at Week 6.|Risk Difference (RD)|3.87|STANDARD_ERROR_OF_MEAN|1.44||0.0071|TWO_SIDED|95.0|1.06|6.69|||Cochran-Mantel-Haenszel|||||6.69|1.06|0.0071
70856804|NCT02815280|141200002|SUPERIORITY||Risk Difference (RD)|1.64|STANDARD_ERROR_OF_MEAN|2.52||0.5143|TWO_SIDED|95.0|-3.3|6.58|||Cochran-Mantel-Haenszel|||||6.58|-3.30|0.5143
70856805|NCT00603642|141200004|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
70856806|NCT00603642|141200005|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
70856807|NCT00603642|141200006|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||ANCOVA|||||||0.0003
70944994|NCT01751165|141390545|NON_INFERIORITY_OR_EQUIVALENCE|Non-nferiority criteria: The upper limit (UL) of the 97.5% confidence interval (CI) for the anti-gE ELISA geometric mean concentration (GMC) ratio (0,2-month schedule over 0,6-month schedule) at one month post-dose 2 had to be below 1.5.|Adjusted GMC ratio|1.19|||||TWO_SIDED|97.5|0.93|1.53|||ANCOVA|||To demonstrate the non-inferiority in terms of anti-gE humoral immune response one month post-dose 2 given according to a 0,12-month schedule compared to a 0,2-month schedule.||1.53|0.93|
71085912|NCT05556148|141677281|OTHER||Mean Difference (Final Values)|-3.3|||<|0.0001|TWO_SIDED|95.0|-3.82|-2.77|||Student's paired t-test|||Day 4||-2.77|-3.82|<.0001
70856808|NCT00603642|141200007|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71085913|NCT05556148|141677281|OTHER||Mean Difference (Final Values)|-2.95|||<|0.0001|TWO_SIDED|95.0|-3.53|-2.37|||Student's paired t-test|||Day 5||-2.37|-3.53|<.0001
70856809|NCT00603642|141200008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6015|||||||Fisher Exact|||||||0.6015
70856810|NCT00924170|141200051|SUPERIORITY||||||<|0.0001|||||||Kaplan Meier|||Published response duration of 15 patients with leukemic adult T cell leukemia treated with Alemtuzumab.||||<0.0001
70856811|NCT00579436|141200065|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||.05
70856812|NCT00579436|141200066|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
71085914|NCT05556148|141677281|OTHER||Mean Difference (Final Values)|-3.26|||<|0.0001|TWO_SIDED|95.0|-3.98|-2.53|||Student's paired t-test|||Day 6||-2.53|-3.98|<.0001
71085915|NCT05556148|141677281|OTHER||Mean Difference (Final Values)|-3.12|||<|0.0001|TWO_SIDED|95.0|-4.08|-2.16|||Student's paired t-test|||Day 7||-2.16|-4.08|<.0001
71085916|NCT05556148|141677282|OTHER||Mean Difference (Final Values)|-1.72|||<|0.0001|TWO_SIDED|95.0|-2.14|-1.31|||Student's paired t-test|||Day 1||-1.31|-2.14|<.0001
71085917|NCT05556148|141677282|OTHER||Mean Difference (Final Values)|-2.12|||<|0.0001|TWO_SIDED|95.0|-2.55|-1.7|||Student's paired t-test|||Day 2||-1.70|-2.55|<.0001
71085918|NCT05556148|141677282|OTHER||Mean Difference (Final Values)|-2.3|||<|0.0001|TWO_SIDED|95.0|-2.71|-1.9|||Student's paired t-test|||Day 3||-1.90|-2.71|<.0001
70856813|NCT00579436|141200067|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.5
70856814|NCT00579436|141200068|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.5
70856815|NCT02312882|141200091|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
70856816|NCT02025556|141200092|SUPERIORITY||Mean Difference (Final Values)|-2.81|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001|TWO_SIDED|95.0|-4.07|-1.55||The threshold for statistical significance was p = .05.|Mixed Models Analysis|||||-1.55|-4.07|< .0001
70856817|NCT02025556|141200092|SUPERIORITY||Mean Difference (Final Values)|-2.64|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001|TWO_SIDED|95.0|-3.9|-1.38||The threshold for statistical significance was p = .05.|Mixed Models Analysis|||||-1.38|-3.9|< .0001
70856818|NCT01203852|141200125|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value for one sided t-test of mean change in blood pressure before and after treatment with metoprolol and chlorthalidone were \<0.0001.|t-test, 1 sided|||||||<0.0001
70856819|NCT01203852|141200126|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value for one sided t-test for mean glucose change before and after treatment with chlorthalidone was \<0.0001.|t-test, 1 sided|||Mean glucose change after treatment with chlorthalidone||||<0.0001
70856820|NCT01203852|141200126|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED|||||P-value for one sided t-test for mean glucose change before and after treatment with metoprolol was 0.049.|t-test, 1 sided|||Mean glucose change after treatment with metoprolol||||0.049
71085919|NCT05556148|141677282|OTHER||Mean Difference (Final Values)|-2.76|||<|0.0001|TWO_SIDED|95.0|-3.23|-2.29|||Student's paired t-test|||Day 4||-2.29|-3.23|<.0001
71085920|NCT05556148|141677282|OTHER||Mean Difference (Final Values)|-2.85|||<|0.0001|TWO_SIDED|95.0|-3.31|-2.39|||Student's paired t-test|||Day 5||-2.39|-3.31|<.0001
70856821|NCT00247611|141200131|SUPERIORITY_OR_OTHER|||||||0.12||||||The p-value was not adjusted for multiple comparisons, and thresholds for significance were 0.05 alpha two tailed.|HLM|||For the ITT sample, the observed pattern of an increasing proportion of participants in the intervention arm reporting perfect adherence as time progressed from was associated with a p-value of 0.12, two-tailed alpha 0.05.||||0.12
71085921|NCT05556148|141677282|OTHER||Mean Difference (Final Values)|-3.18|||<|0.0001|TWO_SIDED|95.0|-3.72|-2.64|||Student's paired t-test|||Day 6||-2.64|-3.72|<.0001
71085922|NCT05556148|141677282|OTHER||Mean Difference (Final Values)|-3.17|||<|0.0001|TWO_SIDED|95.0|-3.9|-2.43|||Student's paired t-test|||Day 7||-2.43|-3.90|<.0001
71085923|NCT05556148|141677283|OTHER||Mean Difference (Final Values)|-1.98|||<|0.0001|TWO_SIDED|95.0|-2.39|-1.57|||Student's paired t-test|||Day 1||-1.57|-2.39|<.0001
71085924|NCT05556148|141677283|OTHER||Mean Difference (Final Values)|-2.24|||<|0.0001|TWO_SIDED|95.0|-2.66|-1.81|||Student's paired t-test|||Day 2||-1.81|-2.66|<.0001
71085925|NCT05556148|141677283|OTHER||Mean Difference (Final Values)|-2.73|||<|0.0001|TWO_SIDED|95.0|-3.14|-2.32|||Student's paired t-test|||Day 3||-2.32|-3.14|<.0001
71085926|NCT05556148|141677283|OTHER||Mean Difference (Final Values)|-2.91|||<|0.0001|TWO_SIDED|95.0|-3.4|-2.43|||Student's paired t-test|||Day 4||-2.43|-3.40|<.0001
71085927|NCT05556148|141677283|OTHER||Mean Difference (Final Values)|-3.17|||<|0.0001|TWO_SIDED|95.0|-3.68|-2.66|||Student's paired t-test|||Day 5||-2.66|-3.68|<.0001
71085928|NCT05556148|141677283|OTHER||Mean Difference (Final Values)|-3.28|||<|0.0001|TWO_SIDED|95.0|-4.02|-2.54|||Student's paired t-test|||Day 6||-2.54|-4.02|<.0001
71085929|NCT05556148|141677283|OTHER||Mean Difference (Final Values)|-3.47|||<|0.0001|TWO_SIDED|95.0|-4.24|-2.7|||Student's paired t-test|||Day 7||-2.70|-4.24|<.0001
71085930|NCT05556148|141677284|OTHER||Mean Difference (Final Values)|-1.96|||<|0.0001|TWO_SIDED|95.0|-2.37|-1.55|||Student's paired t-test|||Day 1||-1.55|-2.37|<.0001
71085931|NCT05556148|141677284|OTHER||Mean Difference (Final Values)|-2.42|||<|0.0001|TWO_SIDED|95.0|-2.83|-2.01|||Student's paired t-test|||Day 2||-2.01|-2.83|<.0001
71085932|NCT05556148|141677284|OTHER||Mean Difference (Final Values)|-2.97|||<|0.0001|TWO_SIDED|95.0|-3.41|-2.53|||Student's paired t-test|||Day 3||-2.53|-3.41|<.0001
71085933|NCT05556148|141677284|OTHER||Mean Difference (Final Values)|-3.34|||<|0.0001|TWO_SIDED|95.0|-3.81|-2.87|||Student's paired t-test|||Day 4||-2.87|-3.81|<.0001
71085934|NCT05556148|141677284|OTHER||Mean Difference (Final Values)|-3.36|||<|0.0001|TWO_SIDED|95.0|-3.84|-2.87|||Student's paired t-test|||Day 5||-2.87|-3.84|<.0001
71085935|NCT05556148|141677284|OTHER||Mean Difference (Final Values)|-3.23|||<|0.0001|TWO_SIDED|95.0|-3.91|-2.56|||Student's paired t-test|||Change from Baseline at Day 6||-2.56|-3.91|<.0001
71085936|NCT05556148|141677284|OTHER||Mean Difference (Final Values)|-3.7|||<|0.0001|TWO_SIDED|95.0|-4.48|-2.92|||Student's paired t-test|||Day 7||-2.92|-4.48|<.0001
71085937|NCT05556148|141677285|OTHER||Mean Difference (Final Values)|-1.76|||<|0.0001|TWO_SIDED|95.0|-2.17|-1.34|||Student's paired t-test|||Day 1||-1.34|-2.17|<.0001
71085938|NCT05556148|141677285|OTHER||Mean Difference (Final Values)|-2.09|||<|0.0001|TWO_SIDED|95.0|-2.51|-1.67|||Student's paired t-test|||Day 2||-1.67|-2.51|<.0001
71085939|NCT05556148|141677285|OTHER||Mean Difference (Final Values)|-2.41|||<|0.0001|TWO_SIDED|95.0|-2.86|-1.97|||Student's paired t-test|||Day 3||-1.97|-2.86|<.0001
71085940|NCT05556148|141677285|OTHER||Mean Difference (Final Values)|-2.74|||<|0.0001|TWO_SIDED|95.0|-3.22|-2.27|||Student's paired t-test|||Day 4||-2.27|-3.22|<.0001
71085941|NCT05556148|141677285|OTHER||Mean Difference (Final Values)|-2.73|||<|0.0001|TWO_SIDED|95.0|-3.3|-2.16|||Student's paired t-test|||Day 5||-2.16|-3.30|<.0001
71085942|NCT05556148|141677285|OTHER||Mean Difference (Final Values)|-2.87|||<|0.0001|TWO_SIDED|95.0|-3.56|-2.19|||Student's paired t-test|||Day 6||-2.19|-3.56|<.0001
71085943|NCT05556148|141677285|OTHER||Mean Difference (Final Values)|-3.2|||<|0.0001|TWO_SIDED|95.0|-4.01|-2.39|||Student's paired t-test|||Day 7||-2.39|-4.01|<.0001
71085944|NCT05556148|141677286|OTHER||Mean Difference (Final Values)|-1.93|||<|0.0001|TWO_SIDED|95.0|-2.35|-1.51|||Student's paired t-test|||Day 1||-1.51|-2.35|<.0001
71085945|NCT05556148|141677286|OTHER||Mean Difference (Final Values)|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.0|-2.2|||Student's paired t-test|||Day 2||-2.20|-3.00|<.0001
71085946|NCT05556148|141677286|OTHER||Mean Difference (Final Values)|-2.65|||<|0.0001|TWO_SIDED|95.0|-3.09|-2.22|||Student's paired t-test|||Day 3||-2.22|-3.09|<.0001
71085947|NCT05556148|141677286|OTHER||Mean Difference (Final Values)|-3.07|||<|0.0001|TWO_SIDED|95.0|-3.53|-2.62|||Student's paired t-test|||Day 4||-2.62|-3.53|<.0001
71085948|NCT05556148|141677286|OTHER||Mean Difference (Final Values)|-3.25|||<|0.0001|TWO_SIDED|95.0|-3.76|-2.75|||Student's paired t-test|||Day 5||-2.75|-3.76|<.0001
71085949|NCT05556148|141677286|OTHER||Mean Difference (Final Values)|-3.41|||<|0.0001|TWO_SIDED|95.0|-4.04|-2.78|||Student's paired t-test|||Day 6||-2.78|-4.04|<.0001
71085950|NCT05556148|141677286|OTHER||Mean Difference (Final Values)|-3.47|||<|0.0001|TWO_SIDED|95.0|-4.3|-2.64|||Student's paired t-test|||Day 7||-2.64|-4.30|<.0001
71085951|NCT05556148|141677287|OTHER||Mean Difference (Final Values)|-2.07|||<|0.0001|TWO_SIDED|95.0|-2.49|-1.66|||Student's paired t-test|||Day 1||-1.66|-2.49|<.0001
71085952|NCT05556148|141677287|OTHER||Mean Difference (Final Values)|-2.76|||<|0.0001|TWO_SIDED|95.0|-3.2|-2.33|||Student's paired t-test|||Day 2||-2.33|-3.20|<.0001
71085953|NCT05556148|141677287|OTHER||Mean Difference (Final Values)|-3.21|||<|0.0001|TWO_SIDED|95.0|-3.63|-2.78|||Student's paired t-test|||Day 3||-2.78|-3.63|<.0001
71085954|NCT05556148|141677287|OTHER||Mean Difference (Final Values)|-3.49|||<|0.0001|TWO_SIDED|95.0|-3.98|-3.0|||Student's paired t-test|||Day 4||-3.00|-3.98|<.0001
71085955|NCT05556148|141677287|OTHER||Mean Difference (Final Values)|-3.83|||<|0.0001|TWO_SIDED|95.0|-4.33|-3.33|||Student's paired t-test|||Day 5||-3.33|-4.33|<.0001
71085956|NCT05556148|141677287|OTHER||Mean Difference (Final Values)|-4.05|||<|0.0001|TWO_SIDED|95.0|-4.65|-3.46|||Student's paired t-test|||Day 6||-3.46|-4.65|<.0001
71085957|NCT05556148|141677287|OTHER||Mean Difference (Final Values)|-4.13|||<|0.0001|TWO_SIDED|95.0|-4.81|-3.46|||Student's paired t-test|||Day 7||-3.46|-4.81|<.0001
71085958|NCT05556148|141677288|OTHER||Mean Difference (Final Values)|-2.21|||<|0.0001|TWO_SIDED|95.0|-2.66|-1.77|||Student's paired t-test|||Day 1||-1.77|-2.66|<.0001
71085959|NCT05556148|141677288|OTHER||Mean Difference (Final Values)|-2.73|||<|0.0001|TWO_SIDED|95.0|-3.15|-2.31|||Student's paired t-test|||Day 2||-2.31|-3.15|<.0001
71085960|NCT05556148|141677288|OTHER||Mean Difference (Final Values)|-3.16|||<|0.0001|TWO_SIDED|95.0|-3.6|-2.73|||Student's paired t-test|||Day 3||-2.73|-3.60|<.0001
71085961|NCT05556148|141677288|OTHER||Mean Difference (Final Values)|-3.52|||<|0.0001|TWO_SIDED|95.0|-4.0|-3.05|||Student's paired t-test|||Day 4||-3.05|-4.00|<.0001
71085962|NCT05556148|141677288|OTHER||Mean Difference (Final Values)|-3.73|||<|0.0001|TWO_SIDED|95.0|-4.19|-3.27|||Student's paired t-test|||Day 5||-3.27|-4.19|<.0001
71085963|NCT05556148|141677288|OTHER||Mean Difference (Final Values)|-4.0|||<|0.0001|TWO_SIDED|95.0|-4.55|-3.45|||Student's paired t-test|||Day 6||-3.45|-4.55|<.0001
71085964|NCT05556148|141677288|OTHER||Mean Difference (Final Values)|-4.07|||<|0.0001|TWO_SIDED|95.0|-4.74|-3.39|||Student's paired t-test|||Day 7||-3.39|-4.74|<.0001
71085965|NCT00458003|141677289|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||.38
71085966|NCT00458003|141677290|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||.10
71085967|NCT01746862|141677331|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|3.47|||<|0.0001|TWO_SIDED|95.0|2.17|4.78|||ANCOVA|Analysis was performed using analysis of covariance (ANCOVA) with baseline age and baseline height as the covariates.||||4.78|2.17|<0.0001
71085968|NCT00490035|141677393|SUPERIORITY_OR_OTHER_LEGACY||Percentage Reduction over Placebo|6.5|||=|0.261|TWO_SIDED|95.0|-5.2|16.9|||ANCOVA|||In order to control the Type I error testing was performed in sequence starting with 50 mg, then 100 mg and finally 20 mg Brivaracetam per day versus Placebo, only moving to the next test if the previous one was significant at the 5 % level.||16.9|-5.2|=0.261
71085969|NCT03519009|141677416|SUPERIORITY||Odds Ratio (OR)|3.4|||<|0.001|TWO_SIDED|95.0|1.8|6.3|||longitudinal logistic regression|||||6.3|1.8|<0.001
71085970|NCT03519009|141677417|SUPERIORITY||Odds Ratio (OR)|2.6|||<|0.001|TWO_SIDED|95.0|1.5|4.4|||longitudinal logistic regression|||||4.4|1.5|<0.001
71085971|NCT06058390|141677418|OTHER||Geometric mean ratio|1.02|||||TWO_SIDED|90.0|0.91|1.14|||||Geometric mean is adjusted for covariates: randomized groups (Arms 1 and 2 of this endpoint), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate.|Analysis was performed on the natural logarithms using a fixed-effects model.||1.14|0.91|
71085972|NCT06058390|141677419|OTHER||Geometric mean ratio|1.05|||||TWO_SIDED|90.0|0.96|1.15|||||Geometric mean is adjusted for covariates: randomized groups (Arms 1 and 2 of this endpoint), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate.|Analysis was performed on the natural logarithms using a fixed-effects model.||1.15|0.96|
71085973|NCT06058390|141677420|OTHER||Geometric mean ratio|1.02|||||TWO_SIDED|90.0|0.88|1.18|||||Geometric mean is adjusted for covariates: randomized groups (Arms 1 and 2 of this endpoint), injection site (arm, thigh and abdomen) as categorical covariates and log transformed baseline weight as continuous covariate.|Analysis was performed on the natural logarithms using a fixed-effects model.||1.18|0.88|
71085974|NCT06058390|141677421|OTHER||Geometric mean ratio|0.98|||||TWO_SIDED|90.0|0.88|1.09|||||Geometric mean is adjusted for covariates: randomized groups (Arms 1 and 2 of this endpoint), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate.|Analysis was performed on the natural logarithms using a fixed-effects model.||1.09|0.88|
71085975|NCT06058390|141677422|OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.87|1.13|||||Geometric mean is adjusted for covariates: randomized groups (Arms 1 and 2 of this endpoint), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate.|Analysis was performed on the natural logarithms using a fixed-effects model.||1.13|0.87|
71085976|NCT06058390|141677423|OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.87|1.08|||||Geometric mean is adjusted for covariates: randomized groups (Arms 1 and 2 of this endpoint), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate.|Analysis was performed on the natural logarithms using a fixed-effects model.||1.08|0.87|
71085977|NCT03877744|141677424|NON_INFERIORITY|Non-inferiority margin of 2.5 was set prior to study initiation with a Type I error of 0.025.|Mean Difference (Final Values)|1.6873|STANDARD_ERROR_OF_MEAN|0.2558||0.0008|ONE_SIDED|97.5||2.1894|||Mixed Models Analysis|Controls technician,site,seat type;Techn. nested in site modeled as random effect;Model allowed heterogeneous variances across arms w Kenward-Roger df|Mixed model allowed the arms to have unequal variance estimates. Degrees of freedom estimated using Kenward-Rogers.|||2.1894||0.0008
71123687|NCT01595581|141753248|OTHER||Mean Difference (Net)|2.17|STANDARD_DEVIATION|2.0||0.48|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||"Power was estimated for change in lean mass of 3.0 plus or minus 1.5 kg in healthy men receiving testosterone. Using a significance level of 0.05 and a power of 0.80, a sample size of 6 participants per group was calculated.~This statistical analysis applies to lean mass in participants 12 weeks post operative."||||0.48
71123688|NCT01595581|141753248|OTHER||Mean Difference (Net)|1.08|STANDARD_DEVIATION|15.0||0.74|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||"Power was estimated for change in lean mass of 3.0 plus or minus 1.5 kg in healthy men receiving testosterone. Using a significance level of 0.05 and a power of 0.80, a sample size of 6 participants per group was calculated.~This statistical analysis applies to lean mass in participants 24 weeks post operative."||||0.74
70856822|NCT00247611|141200131|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||The p-value was not adjusted for multiple comparisons, and thresholds for significance was 0.05 alpha, two tailed.|HLM|||For the on protocol sample, study arm was associated with perfect ACTG-assessed 3-day ARV adherence at p = 0.024, alpha two-tailed.||||0.024
70856823|NCT00247611|141200132|SUPERIORITY_OR_OTHER||||||>|0.5||95.0||||No adjustments were made.|Generalized Linear Model (GLM)|||For the ITT or OP samples, the significance threshold between groups over time for differential increases in proportion with suppressed (undetectable) viral load was p \> 0.50. The study was underpowered to detect differences in Viral load.||||>0.50
71085978|NCT03361306|141677425|SUPERIORITY|Assuming the true VGPR+ rate is 40% under the null hypothesis, then this design will provide 90% power to detect a difference of 20% under the alternative hypothesis, assuming a one-sided alpha=0.10 significance level. For the originally planned enrollment of 40 subjects, if at least 21 subjects achieved VGPR or better to induction, the null hypothesis would be rejected.|Response Rate|0.467||||0.39|TWO_SIDED|95.0|0.213|0.734||This p-value is only based on partial enrollment on the study. As enrollment was halted early, this p-value is descriptive in nature and cannot determine the success/failure of the trial.|Fisher Exact||Confidence interval estimated using the Clopper Pearson method.|||0.734|0.213|0.390
71085979|NCT04817332|141677434|SUPERIORITY||Odds Ratio (OR)|0.72||||0.008|TWO_SIDED|95.0|0.57|0.92|||Odds ratio Ordinal Logistic Regression|adjusted for the stratifying factors of age as a fixed effect and site using robust standard errors to account for clustering||||0.92|0.57|0.008
71085980|NCT04817332|141677435|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.058|TWO_SIDED|95.0|0.76|1.0|||Regression, Cox|||||1.00|0.76|0.058
71085981|NCT04817332|141677438|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.84|1.13||||||||1.13|0.84|
71085982|NCT04817332|141677440|SUPERIORITY||Rate ratio|0.93|||||TWO_SIDED|95.0|0.87|0.99||||||||0.99|0.87|
71085983|NCT04817332|141677441|SUPERIORITY||Rate ratio|1.13|||||TWO_SIDED|95.0|0.73|1.74||||||||1.74|0.73|
71085984|NCT04817332|141677442|SUPERIORITY||Rate ratio|0.84|||||TWO_SIDED|95.0|0.69|1.04||||||||1.04|0.69|
71085985|NCT04817332|141677443|SUPERIORITY||Rate ratio|1.68|||||TWO_SIDED|95.0|1.09|2.58||||||||2.58|1.09|
71085986|NCT04817332|141677444|SUPERIORITY||Rate ratio|1.03|||||TWO_SIDED|95.0|0.92|1.15||||||||1.15|0.92|
71085987|NCT04817332|141677445|SUPERIORITY||Hazard Ratio (HR)|1.41|||||TWO_SIDED|95.0|1.06|1.88||||||||1.88|1.06|
71085988|NCT04817332|141677459|SUPERIORITY||Mean Difference (Final Values)|-67.0|||||TWO_SIDED|95.0|-102.0|-31.0||||||||-31|-102|
71085989|NCT04817332|141677463|SUPERIORITY||Mean Difference (Final Values)|0.003|||||TWO_SIDED|95.0|-0.06|0.066||||||||0.066|-0.06|
71085990|NCT04795466|141677470|SUPERIORITY||Least square mean difference|0.069|STANDARD_ERROR_OF_MEAN|0.1442||0.6386|TWO_SIDED|90.0|-0.178|0.316|||Mixed Models Analysis|||NTB Total z-score - day 171||0.316|-0.178|0.6386
71085991|NCT04795466|141677471|SUPERIORITY||Least squares mean difference|-0.002|STANDARD_ERROR_OF_MEAN|0.1739||0.9917|TWO_SIDED|90.0|-0.3|0.296|||Mixed Models Analysis|||Memory function - day 171||0.296|-0.300|0.9917
71085992|NCT04795466|141677472|SUPERIORITY||least squares mean difference|0.186|STANDARD_ERROR_OF_MEAN|0.1958||0.351|TWO_SIDED|90.0|-0.148|0.52|||Mixed Models Analysis|||Executive function- day 171||0.520|-0.148|0.3510
71085993|NCT04795466|141677473|SUPERIORITY||Repeated measures analysis|-0.49|STANDARD_ERROR_OF_MEAN|1.8||0.787|TWO_SIDED|90.0|-3.56|2.58|||Mixed Models Analysis|||DSST - day 171||2.58|-3.56|0.7870
71085994|NCT02131064|141677525|SUPERIORITY||Difference in tpCR rate|-11.71||||0.0126|TWO_SIDED|95.0|-20.95|-2.48||Threshold for significance at 5%|Cochran-Mantel-Haenszel Chi-Square|The Cochran-Mantel-Haenszel Chi-square test was used and stratified by local hormone receptor status and clinical stage at presentation.||95% CI for the difference in tPCR rates between treatment arms was calculated using normal approximation.||-2.48|-20.95|0.0126
71085995|NCT02131064|141677526|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.7557|TWO_SIDED|95.0|0.37|3.96|||Cochran-Mantel-Haenszel Chi-Square Test|The Cochran-Mantel-Haenszel Chi-square test was used and stratified by local hormone receptor status and clinical stage at presentation.||||3.96|0.37|0.7557
71085996|NCT02131064|141677527|SUPERIORITY||Difference in BCS rate|-10.84||||0.0228|TWO_SIDED|95.0|-20.21|-1.47|||Cochran-Mantel-Haenszel Chi-Square|The Cochran-Mantel-Haenszel Chi-square test was used and stratified by local hormone receptor status and clinical stage at presentation.||95% CI for the difference in BCS rate between treatment arms was calculated using normal approximation.||-1.47|-20.21|0.0228
71123689|NCT03474081|141753261|SUPERIORITY||Mean Difference (Net)|0.095|STANDARD_ERROR_OF_MEAN|0.0167|<|0.001|TWO_SIDED|95.0|0.062|0.128||The MMRM model included Baseline FEV1, visit, geographical region, and treatment as covariates and visit-by-Baseline FEV1 and visit-by-treatment interaction terms.|Mixed model repeated measures (MMRM)|||||0.128|0.062|<0.001
70856824|NCT00247611|141200133|SUPERIORITY_OR_OTHER|||||||0.12||0.0||||The p-value was not adjusted for multiple comparisons and is reported as 0.12 at alpha 0.05 two tailed|HLM|||For the ITT sample (t=586) the observed pattern of an increasing proportion of participants in the intervention arm reporting perfect adherence as time progressed from baseline was associated with a p-value of 0.12, alpha 0.05 two-tailed.||||0.12
70856825|NCT00247611|141200133|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||The p-value was not adjusted for multiple comparisons, and is reported as 0.12 at alpha 0.05 two tailed.|HLM|||For the on protocol sample the pattern of increased proportion of participants in the intervention arm reporting perfect adherence as time progressed from baseline was associated with a p-value of 0.12, alpha 0.05 two-tailed.||||0.12
70856826|NCT00247611|141200134|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||P-value for difference in unemployment rate between On Protocol (OP) sample, and participants excluded from on protocol analysis.||||<0.001
70856827|NCT00247611|141200134|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Chi-squared|||P-value for difference of participants on disability between On Protocol (OP) sample, and participants excluded from on protocol analysis.||||<0.01
70856828|NCT01587898|141200135|SUPERIORITY_OR_OTHER|||||||0.5888|||||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Subgroup: Baseline Hgb||||0.5888
70856829|NCT01587898|141200135|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Subgroup: Baseline Weight||||0.6600
70856830|NCT01587898|141200135|SUPERIORITY_OR_OTHER|||||||0.7999|||||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Subgroup: Baseline estimated glomerular filtration rate (eGFR)||||0.7999
70856831|NCT01587898|141200135|SUPERIORITY_OR_OTHER|||||||0.2092|||||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Ethnicity||||0.2092
71085997|NCT02131064|141677528|SUPERIORITY||Hazard Ratio (HR)|2.61||||0.0027|TWO_SIDED|95.0|1.36|4.98|||Log Rank|The Log Rank was used and stratified by local hormone receptor status and clinical stage at presentation.||||4.98|1.36|0.0027
71085998|NCT02131064|141677529|SUPERIORITY||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.52|2.4||||||||2.40|0.52|
71085999|NCT02131064|141677532|SUPERIORITY||Difference in Deterioration|-24.58|||||TWO_SIDED|95.0|-33.98|-15.19||||||95% CI for the difference in clinically meaningful deterioration in GHS/QoL score between treatment arms was calculated using normal approximation.||-15.19|-33.98|
71086000|NCT02131064|141677533|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.0001|TWO_SIDED|95.0|0.46|0.78|||Log Rank|Log Rank was used and stratified by local hormone receptor status and clinical stage at presentation.||Stratified cox proportional hazards regression model was used to estimate Hazard Ratio and CI. Stratification by hormonal receptor status and clinical stage at presentation (stratification factors).||0.78|0.46|0.0001
71086001|NCT02131064|141677544|SUPERIORITY||Difference in Deterioration|-16.63|||||TWO_SIDED|95.0|-26.32|-6.94||||||This is the statistical analysis for cognitive functioning. 95% CI for the difference in clinically meaningful deterioration in function subscales between treatment arms was calculated using normal approximation.||-6.94|-26.32|
71123690|NCT03474081|141753262|SUPERIORITY||Mean Difference (Net)|0.122|STANDARD_ERROR_OF_MEAN|0.0144|<|0.001|TWO_SIDED|95.0|0.094|0.15||The MMRM model included Baseline FEV1, visit, geographical region, and treatment as covariates and visit-by-Baseline FEV1 and visit-by-treatment interaction terms.|Mixed model repeated measures (MMRM)|||||0.150|0.094|<0.001
71123691|NCT03474081|141753263|SUPERIORITY||Mean Difference (Net)|0.087|STANDARD_ERROR_OF_MEAN|0.0159|<|0.001|TWO_SIDED|95.0|0.056|0.118||The MMRM model included Baseline FEV1, visit, geographical region, and treatment as covariates and visit-by-Baseline FEV1 and visit-by-treatment interaction terms.|Mixed model repeated measures (MMRM)|||||0.118|0.056|<0.001
71123692|NCT01058941|141753273|OTHER||Mean Difference (Net)|-0.42||||0.82|TWO_SIDED|95.0|-3.97|3.13||We used a significance level of p = 0.025 for our measure of ADL changes based on a simple Bonferroni adjustment since we have two primary outcomes.|Mixed Models Analysis|Adjusted for baseline outcome, time from baseline, age, education category, BMI, cholinesterase inhibitors, memantine, vitamin E, and Apo-E.||The target enrollment was 60 subjects, allowing for up to a 20% drop-out. It was calculated that with 48 subjects (24 per group) we would have 80% power to see differences in ADL scores over 18 months between the treatment and placebo groups with a significance level of 0.025 based on a simple Bonferroni adjustment, since we had two primary outcomes.||3.13|-3.97|0.82
71123693|NCT01058941|141753274|OTHER||Mean Difference (Net)|-3.68||||0.001|TWO_SIDED|95.0|-5.9|-1.46||We used a significance level of p = 0.025 for our measure of ADAS-cog changes based on a simple Bonferroni adjustment since we have two primary outcomes.|Mixed Models Analysis|Adjusted for baseline outcome, time from baseline, age, education category, BMI, cholinesterase inhibitors, memantine, vitamin E, and Apo-E.||The target enrollment was 60 subjects, allowing for up to a 20% drop-out. It was calculated that with 48 subjects (24 per group) we would have 80% power to see differences in ADL scores over 18 months between the treatment and placebo groups with a significance level of 0.025 based on a simple Bonferroni adjustment, since we had two primary outcomes.||-1.46|-5.90|0.001
70944995|NCT00943722|141390606|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% confidence interval (CI) of GMT ratio be greater than 0.67.|GMT ratio|1.9|||<|0.001|TWO_SIDED|95.0|1.7|2.14||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 6||2.14|1.70|< 0.001
71086002|NCT02131064|141677544|SUPERIORITY||Difference in Deterioration|-32.54|||||TWO_SIDED|95.0|-41.74|-23.34||||||This is the statistical analysis for physical functioning. 95% CI for the difference in clinically meaningful deterioration in function subscales between treatment arms was calculated using normal approximation.||-23.34|-41.74|
71123694|NCT01274611|141753283|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A sample of 20 patients, or 40 treatment sites (the unit of randomization), provided 80% power to detect effect sizes of 0.68 using a paired t test at a type I error rate of 5%.|Mean Difference (Net)|0.8|||<|0.01|||||||t-test, 2 sided|||||||<0.01
71086003|NCT02131064|141677544|SUPERIORITY||Difference in Deterioration|-28.88|||||TWO_SIDED|95.0|-37.95|-19.8||||||This is the statistical analysis for role functioning. 95% CI for the difference in clinically meaningful deterioration in function subscales between treatment arms was calculated using normal approximation.||-19.80|-37.95|
71086004|NCT00810069|141677547|SUPERIORITY_OR_OTHER|||||||0.213|TWO_SIDED|95.0||||P-value is for early intervention strategy versus delayed intervention strategy.|Kaplan-Meier Analysis|Kaplan-Meier analysis with Wilcoxon test to compare strategies.||Kaplan-Meier Estimates (weeks): analysis of early intervention versus delayed intervention strategies||||0.213
71086005|NCT00810069|141677548|SUPERIORITY_OR_OTHER||survival rate difference|0.02||||0.653|TWO_SIDED|95.0|-0.06|0.1||P-value is for comparison of early intervention versus delayed intervention as a function of survival rate over a 12 week period (Week 4 through Week 16).|Kaplan Meier analysis|P-value for comparison of rates is based on normal approximation using Greenwood's estimation for standard error.||Survival function estimated over a 12 week period (Week 4 through Week 16): analysis of early intervention versus delayed intervention strategies||0.10|-0.06|0.653
71086006|NCT00810069|141677549|SUPERIORITY_OR_OTHER|||||||0.947||95.0||||P-value is for early intervention strategy versus delayed intervention strategy.|Kaplan Meier analysis|Kaplan-Meier analysis with Wilcoxon test to compare strategies.||Analysis of early intervention strategy versus delayed intervention strategy||||0.947
71123695|NCT01274611|141753284|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A sample of 20 patients, or 40 treatment sites (the unit of randomization), provided 80% power to detect effect sizes of 0.68 using a paired t test at a type I error rate of 5%.|Mean Difference (Net)|15.0|||>|0.01|||||||t-test, 2 sided|||||||>0.01
71123696|NCT03449433|141753292|SUPERIORITY||Ratio of LS Means|1.04|||||TWO_SIDED|95.0|0.985|1.1||||||||1.10|0.985|
71123697|NCT02739321|141753297|NON_INFERIORITY|Hypothesized benchmark of 30%|Risk Difference (RD)|25.6|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
71123698|NCT02739321|141753298|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||.001
71123699|NCT02739321|141753299|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||0.001
71123700|NCT02739321|141753300|SUPERIORITY||Median Difference (Final Values)|4.09||||0.268|TWO_SIDED||||||Mixed Models Analysis|||||||.268
71086007|NCT00810069|141677550|SUPERIORITY_OR_OTHER|||||||0.597||95.0||||P-value is for early intervention versus delayed intervention strategies.|Kaplan-Meier analysis|Kaplan-Meier analysis with Wilcoxon test to compare strategies||Analysis of early intervention strategy versus delayed intervention strategy||||0.597
71086008|NCT00810069|141677551|SUPERIORITY_OR_OTHER||LS Mean|-0.04|STANDARD_ERROR_OF_MEAN|0.09||0.624|TWO_SIDED|95.0|-0.22|0.13||P-value for Week 6: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 6||0.13|-0.22|0.624
71086009|NCT00810069|141677551|SUPERIORITY_OR_OTHER||LS Mean|-0.11|STANDARD_ERROR_OF_MEAN|0.09||0.208|TWO_SIDED|95.0|-0.29|0.06||P-value for Week 8: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed Models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 8||0.06|-0.29|0.208
71086010|NCT00810069|141677551|SUPERIORITY_OR_OTHER||LS Mean|-0.19|STANDARD_ERROR_OF_MEAN|0.09||0.044|TWO_SIDED|95.0|-0.37|0.0||P-value for Week 10: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 10||-0.00|-0.37|0.044
71123701|NCT02739321|141753301|SUPERIORITY||Mean Difference (Final Values)|0.94||||0.058|TWO_SIDED||||||Mixed Models Analysis|||||||.058
71123702|NCT02739321|141753302|SUPERIORITY||Mean Difference (Final Values)|2.82||||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||.001
71123703|NCT02739321|141753303|SUPERIORITY|||||||0.232|||||||Mixed Models Analysis|||||||.232
71123704|NCT02739321|141753304|SUPERIORITY|||||||0.1|||||||Mixed Models Analysis|||||||0.100
71123705|NCT02739321|141753305|SUPERIORITY|||||||0.285|||||||Mixed Models Analysis|||||||0.285
71123706|NCT02739321|141753306|SUPERIORITY|||||||0.089|||||||Mixed Models Analysis|||||||0.089
71123707|NCT02739321|141753307|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||0.040
71123708|NCT02739321|141753308|SUPERIORITY|||||||0.471|||||||Mixed Models Analysis|||||||0.471
71123709|NCT02739321|141753309|SUPERIORITY|||||||0.015|||||||Mixed Models Analysis|||||||0.015
71123710|NCT02739321|141753310|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
71123711|NCT02739321|141753311|NON_INFERIORITY|Non-inferiority compared to the median rating of four on the seven point scale (1 = extremely poor, 7 = exceptional) that was used to rate tolerance.|||||||||||||||||The mean rating of parent reported tolerance of mattress technology was 5.61 (SE = 0.25).|||
71123712|NCT02739321|141753312|NON_INFERIORITY|Non-inferiority compared to the median rating of four on the seven point scale (1 = extremely poor, 7 = exceptional) that was used to rate tolerance.|||||||||||||||||The mean rating of parent reported tolerance of actigraph watch was 5.51 (SE = 0.13).|||
71123713|NCT02739321|141753313|NON_INFERIORITY|Non-inferiority compared to the median rating of four on the seven point scale (1 = extremely difficult, 7 = extremely easy) that was used to rate ease of use.|||||||||||||||||The mean rating of parent reported ease of us of the mattress technology was 6.04 (SE = 0.15).|||
71123714|NCT02739321|141753314|SUPERIORITY||Mean Difference (Final Values)|0.51||||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||.001
71123715|NCT01345682|141753317|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.792||||0.0257|TWO_SIDED|95.0|0.643|0.977||Log-rank test stratified by baseline Eastern Cooperative Oncology Group (ECOG) Performance score (PS)(0 or 1) and prior use of Epidermal Growth Factor Receptor (EGFR)-targeted antibody in the Recurrent and/or Metastatic (R/M) setting (Yes or No).|Stratified Log-rank test||"Hazard ratio from Cox proportional hazards model stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"|||0.977|0.643|0.0257
71123716|NCT01345682|141753318|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.958||||0.6755|TWO_SIDED|95.0|0.786|1.169||Log-rank test stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).|Stratified Log-rank test||"Hazard ratio from Cox proportional hazards model stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"|||1.169|0.786|0.6755
71123717|NCT01345682|141753319|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.101|TWO_SIDED|95.0|0.88|4.14|||Regression, Logistic||"Odds ratio, 95% Confidence Interval (CI) and p-value (two-sided) from logistic regression stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"|||4.14|0.88|0.1010
71123718|NCT01345682|141753320|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.0353|TWO_SIDED|95.0|1.03|2.26|||Regression, Logistic||"Odds ratio, 95% CI and p-value (two-sided) from logistic regression stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"|||2.26|1.03|0.0353
71123719|NCT01345682|141753322|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.4|STANDARD_ERROR_OF_MEAN|2.01||0.03|TWO_SIDED|95.0|-8.31|-0.42||Adjusted for baseline ECOG performance score (0 or 1) and prior use of EGFR-targeted antibody for R/M HNSCC (Yes or No).|longitudinal models||Afatinib (BIBW 2992) vs Methotrexate|Changes in scores over time were assessed using longitudinal models, i.e. mixed effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG performance score (PS) and prior use of EGFR-targeted antibody for recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC).||-0.42|-8.31|0.0300
71123720|NCT01345682|141753323|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|2.16||0.9773|TWO_SIDED|95.0|-4.3|4.18||Adjusted for baseline ECOG performance score (0 or 1) and prior use of EGFR-targeted antibody for R/M HNSCC (Yes or No).|longitudinal models||Afatinib (BIBW 2992) vs Methotrexate|Changes in scores over time were assessed using longitudinal models, i.e. mixed effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG PS and prior use of EGFR-targeted antibody for recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC).||4.18|-4.30|0.9773
70944996|NCT00943722|141390606|NON_INFERIORITY|Non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|1.83|||<|0.001|TWO_SIDED|95.0|1.63|2.06||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 11||2.06|1.63|< 0.001
71086011|NCT00810069|141677551|SUPERIORITY_OR_OTHER||LS Mean|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.086|TWO_SIDED|95.0|-0.35|0.02||P-value for Week 12: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interactions, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 12||0.02|-0.35|0.086
71086012|NCT00810069|141677551|SUPERIORITY_OR_OTHER||LS Mean|-0.13|STANDARD_ERROR_OF_MEAN|0.1||0.181|TWO_SIDED|95.0|-0.33|0.06||P-value for Week 14: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 14||0.06|-0.33|0.181
71086013|NCT00810069|141677551|SUPERIORITY_OR_OTHER||LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.994|TWO_SIDED|95.0|-0.2|0.2||P-value for Week 16: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 16||0.20|-0.20|0.994
71086014|NCT00810069|141677552|SUPERIORITY_OR_OTHER||LS Mean|-0.62|STANDARD_ERROR_OF_MEAN|0.19||0.001|TWO_SIDED|95.0|-0.98|-0.25||P-value for Week 6: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 6||-0.25|-0.98|0.001
71086015|NCT00810069|141677552|SUPERIORITY_OR_OTHER||LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.01|TWO_SIDED|95.0|-0.87|-0.12||P-value for Week 8: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 8||-0.12|-0.87|0.010
71086016|NCT00810069|141677552|SUPERIORITY_OR_OTHER||LS Mean|-0.15|STANDARD_ERROR_OF_MEAN|0.2||0.445|TWO_SIDED|95.0|-0.55|0.24||P-value for Week 10: analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 10||0.24|-0.55|0.445
71086017|NCT00810069|141677552|SUPERIORITY_OR_OTHER||LS Mean|-0.29|STANDARD_ERROR_OF_MEAN|0.21||0.169|TWO_SIDED|95.0|-0.71|0.12||P-value for Week 12: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 12||0.12|-0.71|0.169
70944997|NCT00943722|141390606|NON_INFERIORITY|Non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|1.98|||<|0.001|TWO_SIDED|95.0|1.77|2.22||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 16||2.22|1.77|< 0.001
70944998|NCT00943722|141390606|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.44|||<|0.001|TWO_SIDED|95.0|2.13|2.8||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 18||2.80|2.13|< 0.001
71086018|NCT00810069|141677552|SUPERIORITY_OR_OTHER||LS Mean|-0.19|STANDARD_ERROR_OF_MEAN|0.23||0.393|TWO_SIDED|95.0|-0.63|0.25||P-value for Week 14: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 14||0.25|-0.63|0.393
71086019|NCT00810069|141677552|SUPERIORITY_OR_OTHER||LS Mean|-0.15|STANDARD_ERROR_OF_MEAN|0.23||0.51|TWO_SIDED|95.0|-0.61|0.3||P-value for Week 16: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline scores and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 16||0.30|-0.61|0.510
71123721|NCT01345682|141753324|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.6|STANDARD_ERROR_OF_MEAN|1.95||0.7767|TWO_SIDED|95.0|-3.28|4.39||Adjusted for baseline ECOG performance score (0 or 1) and prior use of EGFR-targeted antibody for R/M HNSCC (Yes or No).|longitudinal models||Afatinib (BIBW 2992) vs Methotrexate|Changes in scores over time were assessed using longitudinal models, i.e. mixed effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG PS and prior use of EGFR-targeted antibody for recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC).||4.39|-3.28|0.7767
71123722|NCT01345682|141753325|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.494|TWO_SIDED|95.0|0.717|1.99|||Regression, Logistic||Odds ratio, 95% CI and p-value (two-sided) from logistic regression stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No). Afatinib (BIBW 2992) vs Methotrexate|||1.990|0.717|0.494
71123723|NCT01345682|141753326|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.584|TWO_SIDED|95.0|0.687|1.95|||Regression, Logistic||Odds ratio, 95% CI and p-value (two-sided) from logistic regression stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No). Afatinib (BIBW 2992) vs Methotrexate|||1.950|0.687|0.584
71123724|NCT01345682|141753327|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.816|TWO_SIDED|95.0|0.657|1.705|||Regression, Logistic||Odds ratio, 95% CI and p-value (two-sided) from logistic regression stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No). Afatinib (BIBW 2992) vs Methotrexate|||1.705|0.657|0.816
71123725|NCT01345682|141753328|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0217|TWO_SIDED|95.0|0.55|0.96||Log-rank test stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).|Stratified Log-rank test||Hazard ratio from Cox proportional hazards model stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).|||0.96|0.55|0.0217
71123726|NCT01345682|141753329|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.004|TWO_SIDED|95.0|0.5|0.89||Log-rank test stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).|Stratified Log-rank test||"Hazard ratio from Cox proportional hazards model stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"|||0.89|0.50|0.0040
71123727|NCT01345682|141753330|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.0268|TWO_SIDED|95.0|0.56|0.97||Log-rank test stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).|Stratified Log-rank test||"Hazard ratio from Cox proportional hazards model stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"|||0.97|0.56|0.0268
71086020|NCT00810069|141677553|SUPERIORITY_OR_OTHER||LS Mean|0.14|STANDARD_ERROR_OF_MEAN|0.17||0.401|TWO_SIDED|95.0|-0.19|0.47||P-value for Week 8: Analysis of early intervention versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 8||0.47|-0.19|0.401
71086021|NCT00810069|141677553|SUPERIORITY_OR_OTHER||LS Mean|0.09|STANDARD_ERROR_OF_MEAN|0.19||0.618|TWO_SIDED|95.0|-0.27|0.46||P-value for Week 12: Analysis of early intervention versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 12||0.46|-0.27|0.618
71086022|NCT00810069|141677553|SUPERIORITY_OR_OTHER||LS Mean|-0.04|STANDARD_ERROR_OF_MEAN|0.2||0.856|TWO_SIDED|95.0|-0.43|0.36||P-value for Week 16: Analysis of early intervention versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 16||0.36|-0.43|0.856
71086023|NCT00810069|141677554|SUPERIORITY_OR_OTHER||LS Mean|-0.05|STANDARD_ERROR_OF_MEAN|0.02||0.021|TWO_SIDED|95.0|-0.1|-0.01||P-value for Week 8: Analysis of early versus delayed intervention LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 8||-0.01|-0.10|0.021
71086024|NCT00810069|141677554|SUPERIORITY_OR_OTHER||LS Mean|-0.04|STANDARD_ERROR_OF_MEAN|0.02||0.071|TWO_SIDED|95.0|-0.09|0.0||P-value for Week 12: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 12||0.00|-0.09|0.071
71086025|NCT00810069|141677554|SUPERIORITY_OR_OTHER||LS Mean|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.792|TWO_SIDED|95.0|-0.05|0.06||P-value for Week 16: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 16||0.06|-0.05|0.792
71086026|NCT00810069|141677555|SUPERIORITY_OR_OTHER||LS Mean|-0.37|STANDARD_ERROR_OF_MEAN|0.7||0.597|TWO_SIDED|95.0|-1.74|1.0||P-value for Week 8: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 8||1.00|-1.74|0.597
71086027|NCT00810069|141677555|SUPERIORITY_OR_OTHER||LS Mean|-0.68|STANDARD_ERROR_OF_MEAN|0.74||0.36|TWO_SIDED|95.0|-2.13|0.78||P-value for Week 12: Analysis for early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 12||0.78|-2.13|0.360
71086028|NCT00810069|141677555|SUPERIORITY_OR_OTHER||LS Mean|0.06|STANDARD_ERROR_OF_MEAN|0.81||0.937|TWO_SIDED|95.0|-1.52|1.65||P-value for Week 16: Analysis for early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 16||1.65|-1.52|0.937
71086029|NCT00810069|141677556|SUPERIORITY_OR_OTHER|||||||0.075||95.0||||P-value is for early intervention strategy versus delayed intervention strategy.|Kaplan-Meier analysis|Kaplan-Meier analysis with Wilcoxon test to compare strategies||Kaplan-Meier estimates (weeks): analysis of early intervention versus delayed intervention strategies||||0.075
71086030|NCT00810069|141677557|SUPERIORITY_OR_OTHER||Survival rate difference|-0.07||||0.116|TWO_SIDED|95.0|-0.16|0.02||P-value is for comparison of early intervention versus delayed intervention as a function of survival rate over a 12 week period (Week 4 through Week 16).|Kaplan-Meier analysis|P-value for comparison of rates is based on normal approximation using Greenwood's estimation for standard error.||Survival function estimated over a 12 week period (Week 4 through Week 16): analysis of early intervention versus delayed intervention strategies||0.02|-0.16|0.116
71086031|NCT03675360|141677565|SUPERIORITY||Mean Difference (Net)|-0.23|||<|0.05|TWO_SIDED|95.0|-0.32|-0.14|||linear mixed effects model|||||-0.14|-0.32|<0.05
71086032|NCT03675360|141677566|SUPERIORITY||Mean Difference (Net)|-10.3|||<|0.05|TWO_SIDED|95.0|-15.6|-4.9|||linear mixed effects model|||||-4.9|-15.6|<0.05
71086033|NCT03675360|141677567|SUPERIORITY||Mean Difference (Net)|-3.2|||<|0.05|TWO_SIDED|95.0|-7.3|0.9|||linear mixed effects model|||||0.9|-7.3|<0.05
71086034|NCT03675360|141677568|SUPERIORITY||Median Difference (Final Values)|-0.13|||<|0.05|TWO_SIDED|95.0|-0.31|0.05|||linear mixed effects model|||||0.05|-0.31|<0.05
71086035|NCT03675360|141677569|SUPERIORITY||Mean Difference (Net)|-5.9|||<|0.05|TWO_SIDED|95.0|-7.4|-4.4|||linear mixed effects model|||||-4.4|-7.4|<0.05
71086036|NCT03675360|141677570|SUPERIORITY||Mean Difference (Net)|-6.2|||<|0.05|TWO_SIDED|95.0|-10.5|-2.0|||linear mixed effects model|||||-2.0|-10.5|<0.05
71086037|NCT03675360|141677571|SUPERIORITY||Mean Difference (Net)|-2.4|||<|0.05|TWO_SIDED|95.0|-3.7|-1.1|||linear mixed effects model|||||-1.1|-3.7|<0.05
71086038|NCT03675360|141677572|SUPERIORITY||Mean Difference (Net)|-2.6|||<|0.05|TWO_SIDED|95.0|-5.2|0.0|||linear mixed effects model|||||0|-5.2|<0.05
71086039|NCT03675360|141677573|SUPERIORITY||Mean Difference (Net)|-4.7|||<|0.05|TWO_SIDED|95.0|-6.7|-2.6|||linear mixed effects model|||||-2.6|-6.7|<0.05
71086040|NCT03675360|141677574|SUPERIORITY||Mean Difference (Net)|-0.8|||<|0.05|TWO_SIDED|95.0|-1.8|0.3|||linear mixed effects model|||||0.3|-1.8|<0.05
71086041|NCT04767373|141677587|OTHER||Efficacy estimate|60.4|||<|0.001|TWO_SIDED|95.0|44.1|71.9|||Exact method|One-sided p-value was estimated using an exact method.|A modified Poisson regression with robust variance method was used to generate efficacy estimate (1- Relative Risk \[RR\]) \& 95% confidence interval (CI). The model included region, gestational age, and age at randomization as covariates.|||71.9|44.1|<0.001
70856832|NCT01587898|141200135|SUPERIORITY_OR_OTHER|||||||0.9996||95.0|||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Geographic Ancestry||||0.9996
71086042|NCT04767373|141677588|OTHER||Estimated Percentage Difference|-0.5|||||TWO_SIDED|95.0|-2.6|1.5|||||Estimated percentage difference beteween Clesrovimab 105 mg arm and placebo arm and associated 95% CI were calculated based on the Miettinen \& Nurminen method.|||1.5|-2.6|
70856833|NCT01587898|141200135|SUPERIORITY_OR_OTHER|||||||0.7002|||||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Sex||||0.7002
71086043|NCT04767373|141677589|OTHER||Estimated Percentage Difference|-0.6|||||TWO_SIDED|95.0|-1.4|0.0|||||Estimated percentage difference between Clesrovimab 105 mg arm and placebo arm and associated 95% CI were calculated based on the Miettinen \& Nurminen method.|||-0.0|-1.4|
71086044|NCT04767373|141677590|OTHER||Estimated Percentage Difference|-1.8|||||TWO_SIDED|95.0|-5.0|1.2|||||Estimated percentage difference between Clesrovimab 105 mg arm and placebo arm and associated 95% CI were calculated based on the Miettinen \& Nurminen method.|||1.2|-5.0|
71086045|NCT04767373|141677591|OTHER||Estimated Percentage Difference|0.0|||||TWO_SIDED|95.0|-0.3|0.2|||||Estimated percentage difference between Clesrovimab 105 mg arm and placebo arm and associated 95% CI were calculated based on the Miettinen \& Nurminen method.|||0.2|-0.3|
71086046|NCT04767373|141677592|OTHER||Estimated Percentage Difference|0.1|||||TWO_SIDED|95.0|-0.4|0.5|||||Estimated percentage difference between Clesrovimab 105 mg arm and placebo arm and associated 95% CI were calculated based on the Miettinen \& Nurminen method.|||0.5|-0.4|
71086047|NCT04767373|141677595|OTHER||Efficacy estimate|84.2|||<|0.001|TWO_SIDED|95.0|66.6|92.6||One-sided p-value was estimated using an exact method.|Exact method||A modified Poisson regression with robust variance method was used to generate efficacy estimate (1- RR) \& 95% CI. The model included region, gestational age, and age at randomization as covariates.|||92.6|66.6|<0.001
71086048|NCT04767373|141677596|OTHER||Efficacy estimate|59.5|||||TWO_SIDED|95.0|43.3|71.1|||||A modified Poisson regression with robust variance method was used to generate efficacy estimate (1- RR) \& 95% CI. The model included region, gestational age, and age at randomization as covariates.|||71.1|43.3|
71086049|NCT00593918|141677598|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Mixed Models Analysis|A mixed random effects model was used both unadjusted and adjustment for relevant co-variates obtained from the literature.||||||0.04
71086050|NCT00593918|141677599|SUPERIORITY_OR_OTHER|||||||0.14||95.0||||Analysis was per protocol based on the number of children enrolled by genotype and completed nasal washes at first visit.|Mixed Models Analysis|A mixed random effects model was used both unadjusted and adjustment for relevant co-variates obtained from the literature.||||||0.14
71086051|NCT01569126|141677639|SUPERIORITY_OR_OTHER||Slope|0.026||||||95.0|||||||The correlation of time-matched change from baseline QTcF interval (dependent variable) to the time-matched plasma concentration of total fluoxetine and norfluoxetine (covariate) and participant (random effect).|||||
71086052|NCT00791219|141677652|NON_INFERIORITY|To demonstrate non-inferiority an upper bound 95% confidence interval approach comparing the difference between the cure rate in the Test and the Reference groups was used. If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure, Clinical Cure and Mycological Cure as appropriate, at Week 24 was greater than -20 then non-inferiority was considered to have been demonstrated|-20|6.47|||||ONE_SIDED|95.0|-1.77||||||||||-1.77|
71086053|NCT00791219|141677652|SUPERIORITY||||||<|0.05|||||||one-sided continuity corrected Z-test|||The ITT was used for all superiority testing. For the three primary endpoints and all four secondary endpoints, if the difference between the proportion of patients considered a cure was statistically greater (p\<0.05) than the proportion of patients considered a cure in the Placebo group, then superiority was considered to have been demonstrated. A one-sided continuity corrected Z-test was used for superiority testing||||<0.05
71123728|NCT00897390|141753334|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|1.042|||||TWO_SIDED|90.0|1.009|1.075||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.075|1.009|
71123729|NCT00897390|141753334|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.988|||||TWO_SIDED|90.0|0.958|1.019||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.019|0.958|
70856834|NCT01587898|141200135|SUPERIORITY_OR_OTHER|||||||0.5536||95.0|||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Age||||0.5536
71123730|NCT00897390|141753336|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|1.045|||||TWO_SIDED|90.0|1.013|1.077||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.077|1.013|
71123731|NCT00897390|141753336|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.992|||||TWO_SIDED|90.0|0.962|1.022||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.022|0.962|
71123732|NCT00897390|141753337|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|1.077|||||TWO_SIDED|90.0|0.978|1.185||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.185|0.978|
71123733|NCT00897390|141753337|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.987|||||TWO_SIDED|90.0|0.9|1.083||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.083|0.900|
71123734|NCT00897390|141753340|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.974|||||TWO_SIDED|90.0|0.921|1.03||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.030|0.921|
71123735|NCT00897390|141753340|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.966||||||90.0|0.915|1.02||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.020|0.915|
71123736|NCT00897390|141753341|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.962||||||90.0|0.906|1.02||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.020|0.906|
70856835|NCT01587898|141200135|SUPERIORITY_OR_OTHER|||||||0.0085||95.0|||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Co-administration with food||||0.0085
70856836|NCT01587898|141200135|SUPERIORITY_OR_OTHER|||||||0.0021||95.0|||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Diabetic||||0.0021
70856837|NCT01587898|141200135|SUPERIORITY_OR_OTHER|||||||0.2194||95.0|||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Region||||0.2194
70856838|NCT03039621|141200228|SUPERIORITY|||||||0.026||||||a priori threshold for statistical significance equals 0.05|Wilcoxon (Mann-Whitney)|||||||0.026
70856839|NCT03039621|141200229|SUPERIORITY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||||||0.031
70856840|NCT03039621|141200230|SUPERIORITY|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||||||0.022
70856841|NCT03039621|141200231|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||||||0.024
70856842|NCT03039621|141200232|SUPERIORITY|||||||0.0201||||||"The p-value associated with treatment factor of total severity index of the disease from Day 2 to Day 3, 4, 5 and 6 endpoint between Ergoferon and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.0201
70856843|NCT03039621|141200233|SUPERIORITY|||||||0.046|||||||Wilcoxon (Mann-Whitney)|||||||0.046
70856844|NCT03039621|141200234|SUPERIORITY|||||||0.0025|||||||Cochran-Mantel-Haenszel|||||||0.0025
70856845|NCT03039621|141200234|OTHER|Test for assessing the homogeneity of the odds ratio in several 2 × 2 contingency tables.||||||0.22|||||||Breslow-Day test|||||||0.22
70856846|NCT03039621|141200235|SUPERIORITY|||||||0.0037||||||"The p-value associated with treatment factor of total severity index of the disease from Day 1 to Day 2, 3 and 4 endpoint between Ergoferon and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.0037
71086054|NCT00791219|141677653|NON_INFERIORITY|To demonstrate non-inferiority an upper bound 95% confidence interval approach comparing the difference between the cure rate in the Test and the Reference groups was used. If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure, Clinical Cure and Mycological Cure as appropriate, at Week 24 was greater than -20 then non-inferiority was considered to have been demonstrated|-20|10.38|||||ONE_SIDED|95.0|0.92|||||||To demonstrate non-inferiority an upper bound 95% confidence interval approach comparing the difference between the cure rate in the Test and the Reference groups was used. If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure, Clinical Cure and Mycological Cure as appropriate, at Week 24 was greater than -20 then non-inferiority was considered to have been demonstrated|||0.92|
71086055|NCT00791219|141677653|SUPERIORITY||||||<|0.05|||||||one-sided continuity corrected Z-test|||The ITT was used for all superiority testing. For the three primary endpoints and all four secondary endpoints, if the difference between the proportion of patients considered a cure was statistically greater (p\<0.05) than the proportion of patients considered a cure in the Placebo group, then superiority was considered to have been demonstrated. A one-sided continuity corrected Z-test was used for superiority testing||||<0.05
71086056|NCT00791219|141677654|NON_INFERIORITY|To demonstrate non-inferiority an upper bound 95% confidence interval approach comparing the difference between the cure rate in the Test and the Reference groups was used. If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure, Clinical Cure and Mycological Cure as appropriate, at Week 24 was greater than -20 then non-inferiority was considered to have been demonstrated|-20|3.17|||||ONE_SIDED|95.0|-10.62||||||||||-10.62|
71086057|NCT00791219|141677654|SUPERIORITY||||||<|0.05|||||||one-sided continuity corrected Z-test|||The ITT was used for all superiority testing. For the three primary endpoints and all four secondary endpoints, if the difference between the proportion of patients considered a cure was statistically greater (p\<0.05) than the proportion of patients considered a cure in the Placebo group, then superiority was considered to have been demonstrated. A one-sided continuity corrected Z-test was used for superiority testing||||<0.05
71086058|NCT00791219|141677657|NON_INFERIORITY|If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure, Clinical Cure or Mycological Cure as appropriate at Visit 7 was greater than -20 then non-inferiority was considered to have been demonstrated|-20|-0.57|||||ONE_SIDED|95.0|-12.91|||||||If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure, Clinical Cure or Mycological Cure as appropriate at Visit 7 was greater than -20 then non-inferiority was considered to have been demonstrated|||-12.91|
71123737|NCT00897390|141753341|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.974||||||90.0|0.92|1.032||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.032|0.920|
71123738|NCT00897390|141753342|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.937|||||TWO_SIDED|90.0|0.864|1.016||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.016|0.864|
71123739|NCT00897390|141753342|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.964|||||TWO_SIDED|90.0|0.891|1.042||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.042|0.891|
70944999|NCT00943722|141390606|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.51|||<|0.001|TWO_SIDED|95.0|2.21|2.85||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 31||2.85|2.21|< 0.001
71123740|NCT01294163|141753354|NON_INFERIORITY_OR_EQUIVALENCE|Xenon was to be concluded non-inferior to sevoflurane if the upper bound of the 2-sided 95% CI for the difference \[mean troponin I level (xenon) - mean troponin I level (sevoflurane)\] was below the prespecified margin of 0.63 ng/mL. Assuming a margin of 0.63, a same concentration of troponin I at 24 hours in the xenon and sevoflurane groups, a common standard deviation of 1.9 ng/mL and a one-sided type I error of 0.025, 164 patients per group were deemed necessary to demonstrate non-inferiority.|Mean Difference (Final Values)|-0.4||||0.02|TWO_SIDED|95.0|-1.27|0.47|||ANCOVA|Treatment difference and 95%CI assessed using ANCOVA with 24h troponin I as response, treatment group and pre-induction troponin I as covariates.||||0.47|-1.27|0.02
71123741|NCT01294163|141753363|NON_INFERIORITY_OR_EQUIVALENCE|It was to be concluded that xenon was non-inferior to sevoflurane if the upper bound of the 2-sided 95% CI for the difference \[mean troponin I level (xenon) - mean troponin I level (sevoflurane)\] was below the margin of 0.15 ng/mL.|Mean Difference (Final Values)|-0.09||||0.0186|TWO_SIDED|95.0|-0.3|0.11|||ANCOVA|||As the residuals from the primary ANCOVA model were non-normal and skewed, the non-inferiority analysis was repeated using log-transformed blood troponin levels.||0.11|-0.30|0.0186
71123742|NCT00958217|141753364|SUPERIORITY_OR_OTHER||2nd order effects of time (2 slope|33.0|||<|0.05|TWO_SIDED|95.0||||P-values based on likelihood ratio tests for the significance of the first and second order trajectory parameters. Primary tests compared curvilinear trajectories of the two treatment groups.|Linear Mixed Effects Models||We gauged sampling error with 95% confidence bands.|Data analyses included comparison of mean scores and linear mixed effects models used to ascertain trajectories for depression symptoms.||||<.05
71123743|NCT00958217|141753365|SUPERIORITY_OR_OTHER||Second order effect of time (2 slopes)|57.0|||<|0.05|TWO_SIDED|95.0|||||Linear Mixed Effects Models||We gauged sampling error with 95% confidence bands.|||||<.05
71123744|NCT00958217|141753366|SUPERIORITY_OR_OTHER||Second order effect of time (2 slopes)|0.43|||<|0.05|TWO_SIDED|95.0|||||Linear Mixed Effects Model|A logit link was used in this model.|We gauged sampling error with 95% confidence bands.|Analysis of substance use was conducted using trajectories modeled as a dichotomous outcome using logit links to predict the probability of substance use (any alcohol or drug use) on a particular day.||||<.05
71123745|NCT00958217|141753366|SUPERIORITY_OR_OTHER||Second order effect of time (2 slopes)|0.26|||<|0.05|TWO_SIDED||||||Linear Mixed Effects Model|A logit link was used in this model|We gauged sampling error with 95% confidence bands.|Second statistical analysis evaluates trajectories of heavy drinking (\<5 drinks on a given day) Analysis of heavy drinking was conducted using trajectories modeled as a dichotomous outcome using logit links to predict the probability of heavy drinking (5 or more drinks) on a particular day.||||<.05
71123746|NCT01742065|141753395|SUPERIORITY|To assess effectiveness, we fit generalized estimating equations (GEE) with a logistic link to model patient-level data. We weighted patient data so that each clinic's data had an equal weight. Models were adjusted for age, sex, and health center. They used robust variance estimators and independent correlation structures. We specified clinic as a clustering variable to account for intraclinic correlation; the intraclinic correlation coefficient was 0.05 after model covariates adjustment.|Mean Difference (Final Values)|3.4||||0.05|TWO_SIDED|95.0|0.1|6.8||We report effectiveness as the absolute difference between intervention and usual care clinics in adjusted probabilities calculated using mean values for all covariates;|Generalized Estimating Equations (GEE)|Reported P values based on the corresponding adjusted odds ratio and account for reduced degrees of freedom owing to clustering.||||6.8|.1|.05
71123747|NCT01742065|141753396|OTHER|To assess effectiveness, we fit generalized estimating equations (GEE) with a logistic link to model patient-level data. We weighted patient data so that each clinic's data had an equal weight. Models were adjusted for age, sex, and health center. They used robust variance estimators and independent correlation structures. We specified clinic as a clustering variable to account for intraclinic correlation; the intraclass correlation coefficient was 0.05 after covariable adjustment.|Mean Difference (Final Values)|3.8||||0.02|TWO_SIDED|95.0|0.6|7.0||We report effectiveness as the absolute difference between intervention and usual care clinics in adjusted probabilities calculated using mean values for all covariates;|Generalized Estimating Equations (GEE)|Reported P values based on the corresponding adjusted odds ratio and account for reduced degrees of freedom owing to clustering.||||7|.6|.02
71123748|NCT02440789|141753403|OTHER|||||||0.56|||||||t-test, 2 sided|paired t-test||||||0.56
71123749|NCT02440789|141753405|OTHER|||||||0.11|||||||t-test, 2 sided|paired t-test||||||0.11
71123750|NCT02440789|141753407|OTHER|||||||0.93|||||||t-test, 2 sided|paired t-test; results less than the analysis lower limit (0.7 cp/mL) were imputed to a value of one half the analysis lower limit.||||||0.93
71123751|NCT02440789|141753409|OTHER|||||||0.041|||||||t-test, 2 sided|paired t-test||||||0.041
71123752|NCT02440789|141753412|OTHER|||||||0.008|||||||t-test, 2 sided|paired t-test||||||0.008
71123753|NCT02440789|141753414|OTHER|||||||0.26|||||||t-test, 2 sided|paired t-test||||||0.26
71123754|NCT02440789|141753416|OTHER|||||||0.75|||||||t-test, 2 sided|paired t-test||||||0.75
71123755|NCT02440789|141753418|OTHER|||||||0.97|||||||t-test, 2 sided|paired t-test||||||0.97
71123756|NCT02440789|141753420|OTHER|||||||0.7|||||||t-test, 2 sided|paired t-test||||||0.7
71123757|NCT02440789|141753422|OTHER|||||||0.47|||||||t-test, 2 sided|paired t-test||||||0.47
70856847|NCT03039621|141200236|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||||||0.0001
71123758|NCT02440789|141753424|OTHER|||||||0.72|||||||t-test, 2 sided|paired t-test||||||0.72
71123759|NCT02440789|141753426|OTHER|||||||0.28|||||||t-test, 2 sided|paired t-test||||||0.28
71123760|NCT02440789|141753428|OTHER|||||||0.7|||||||t-test, 2 sided|paired t-test||||||0.7
71123761|NCT02440789|141753430|OTHER|||||||0.28|||||||t-test, 2 sided|paired t-test||||||0.28
71123762|NCT02440789|141753432|OTHER|||||||0.77|||||||t-test, 2 sided|paired t-test||||||0.77
71123763|NCT02440789|141753434|OTHER|||||||0.93|||||||t-test, 2 sided|paired t-test||||||0.93
71123764|NCT02440789|141753436|OTHER|||||||0.65|||||||t-test, 2 sided|paired t-test||||||0.65
71086059|NCT00791219|141677658|SUPERIORITY||Mean Difference (Final Values)|0.0018|||<|0.05|TWO_SIDED|||||It the difference between the proportion of patients considered a cure was statistically greater (p\<0.05) than the proportion of patients considered a cure in the Placebo group, then superiority was considered to have been demonstrated.|A one-sided continuity corrected Z-test|||For the three primary endpoints and all four dichotomous secondary endpoints, if the difference between the proportion of patients considered a cure in the Test or Reference group was statistically greater (p \< 0.05) than the proportion of patients considered a cure in the Placebo group, then superiority of that treatment over placebo was considered to have been demonstrated. A one-sided continuity corrected Z-test was used for superiority testing.||||<0.05
71086060|NCT00791219|141677658|SUPERIORITY||Median Difference (Final Values)|0.0853|||<|0.05|TWO_SIDED||||||A one-sided continuity corrected Z-test|||For the three primary endpoints and all four dichotomous secondary endpoints, if the difference between the proportion of patients considered a cure in the Test or Reference group was statistically greater (p \< 0.05) than the proportion of patients considered a cure in the Placebo group, then superiority of that treatment over placebo was considered to have been demonstrated. A one-sided continuity corrected Z-test was used for superiority testing.||||<0.05
71086061|NCT02358031|141677669|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.21211|TWO_SIDED|95.0|0.78|1.11||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||PFS in all participants of the pembro combo arm was compared to PFS in all participants of the control arm to address the sixth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||1.11|0.78|0.21211
71086062|NCT02358031|141677670|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.03697|TWO_SIDED|95.0|0.69|1.02||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||PFS in CPS ≥1 participants of the pembro combo arm was compared to PFS in CPS ≥1 participants of the control arm to address the fifth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||1.02|0.69|0.03697
71086063|NCT02358031|141677671|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.02951|TWO_SIDED|95.0|0.58|1.01||One-sided p-value based on log-rank test stratified by ECOG and HPV status.|Regression, Cox|||PFS in CPS ≥20 participants of the pembro combo arm was compared to PFS in CPS ≥20 participants of the control arm to address the fourth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG and HPV status.||1.01|0.58|0.02951
71086064|NCT02358031|141677672|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.00025|TWO_SIDED|95.0|0.6|0.87||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||OS in all participants of the pembro combo arm was compared to OS in all participants of the control arm to address the fourteenth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||0.87|0.60|0.00025
71086065|NCT02358031|141677673|SUPERIORITY||Hazard Ratio (HR)|0.65||||2e-05|TWO_SIDED|95.0|0.53|0.8||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||OS in CPS ≥1 participants of the pembro combo arm was compared to OS in CPS ≥1 participants of the control arm to address the twelfth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||0.80|0.53|0.00002
71086066|NCT02358031|141677674|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.00044|TWO_SIDED|95.0|0.45|0.82||One-sided p-value based on log-rank test stratified by ECOG and HPV status.|Regression, Cox|||OS in CPS ≥20 participants of the pembro combo arm was compared to OS in CPS ≥20 participants of the control arm to address the eleventh primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG and HPV status.||0.82|0.45|0.00044
71086067|NCT02358031|141677675|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.9983|TWO_SIDED|95.0|1.09|1.53||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||PFS in all participants of the pembro mono arm was compared to PFS in all participants of the control arm to address the third primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||1.53|1.09|0.99830
71086068|NCT02358031|141677676|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.8958|TWO_SIDED|95.0|0.94|1.36||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||PFS in CPS ≥1 participants of the pembro mono arm was compared to PFS in CPS ≥1 participants of the control arm to address the second primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||1.36|0.94|0.89580
71086069|NCT02358031|141677677|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.46791|TWO_SIDED|95.0|0.76|1.29||One-sided p-value based on log-rank test stratified by ECOG and HPV status.|Regression, Cox|||PFS in CPS ≥20 participants of the pembro mono arm was compared to PFS in CPS ≥20 participants of the control arm to address the first primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG and HPV status.||1.29|0.76|0.46791
71086070|NCT02358031|141677678|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.01985|TWO_SIDED|95.0|0.7|0.99||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||OS in all participants of the pembro mono arm was compared to OS in all participants of the control arm to address the tenth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||0.99|0.70|0.01985
71086071|NCT02358031|141677679|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.00133|TWO_SIDED|95.0|0.61|0.9||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||OS in CPS ≥1 participants of the pembro mono arm was compared to OS in CPS ≥1 participants of the control arm to address the eighth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||0.90|0.61|0.00133
71123765|NCT02440789|141753438|OTHER|||||||0.22|||||||t-test, 2 sided|paired t-test||||||0.22
71123766|NCT02440789|141753440|OTHER|||||||0.031|||||||t-test, 2 sided|paired t-test||||||0.031
71123767|NCT02440789|141753442|OTHER|||||||0.005|||||||t-test, 2 sided|paired t-test||||||0.005
70945000|NCT00943722|141390606|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.1|||<|0.001|TWO_SIDED|95.0|1.87|2.36||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 33||2.36|1.87|< 0.001
70945001|NCT00943722|141390606|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.62|||<|0.001|TWO_SIDED|95.0|2.27|3.03||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 45||3.03|2.27|< 0.001
70945002|NCT00943722|141390606|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.22|||<|0.001|TWO_SIDED|95.0|1.97|2.51||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 52||2.51|1.97|< 0.001
70945003|NCT00943722|141390606|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.18|||<|0.001|TWO_SIDED|95.0|1.93|2.45||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 58||2.45|1.93|< 0.001
70945004|NCT00943722|141390607|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.31|||<|0.001|TWO_SIDED|95.0|2.07|2.59||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 6||2.59|2.07|< 0.001
70945005|NCT00943722|141390607|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.1|||<|0.001|TWO_SIDED|95.0|1.88|2.36||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 11||2.36|1.88|< 0.001
70945006|NCT00943722|141390607|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.45|||<|0.001|TWO_SIDED|95.0|2.19|2.74||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 16||2.74|2.19|< 0.001
70945007|NCT00943722|141390607|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|3.2|||<|0.001|TWO_SIDED|95.0|2.8|3.65||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 18||3.65|2.80|< 0.001
70945008|NCT00943722|141390607|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.95|||<|0.001|TWO_SIDED|95.0|2.6|3.34||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 31||3.34|2.60|< 0.001
70945009|NCT00943722|141390607|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.57|||<|0.001|TWO_SIDED|95.0|2.29|2.88||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 33||2.88|2.29|< 0.001
71086072|NCT02358031|141677680|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.0001|TWO_SIDED|95.0|0.44|0.78||One-sided p-value based on log-rank test stratified by ECOG and HPV status.|Regression, Cox|||OS in CPS ≥20 participants of the pembro mono arm was compared to OS in CPS ≥20 participants of the control arm to address the seventh primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG and HPV status.||0.78|0.44|0.00010
71086073|NCT02358031|141677687|OTHER||Difference in ORR Percentage|-0.8||||0.574|TWO_SIDED|95.0|-8.7|7.2||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in all participants of the pembro combo arm was compared to ORR in all participants of the control arm. The comparison was based on Miettinen \& Nurminen method stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||7.2|-8.7|0.5740
71123768|NCT02440789|141753444|OTHER|||||||0.69|||||||t-test, 2 sided|paired t-test||||||0.69
71123769|NCT02440789|141753446|OTHER|||||||0.008|||||||t-test, 2 sided|paired t-test||||||0.008
70945010|NCT00943722|141390607|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|3.33|||<|0.001|TWO_SIDED|95.0|2.89|3.84||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 45||3.84|2.89|< 0.001
70945011|NCT00943722|141390607|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.47|||<|0.001|TWO_SIDED|95.0|2.19|2.79||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 52||2.79|2.19|< 0.001
70945012|NCT00943722|141390607|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.66|||<|0.001|TWO_SIDED|95.0|2.37|2.98||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 58||2.98|2.37|< 0.001
70945013|NCT00943722|141390608|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|0.97|||||TWO_SIDED|95.0|0.88|1.08|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 6||1.08|0.88|
70945014|NCT00943722|141390608|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|1.03|||||TWO_SIDED|95.0|0.93|1.16|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 6||1.16|0.93|
70945015|NCT00943722|141390608|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|1.06|||||TWO_SIDED|95.0|0.95|1.19|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 6||1.19|0.95|
70945016|NCT00943722|141390608|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|1.0|||||TWO_SIDED|95.0|0.9|1.11|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 11||1.11|0.90|
70872019|NCT01652703|141229475|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-63.94|STANDARD_ERROR_OF_MEAN|3.18|<|0.001|TWO_SIDED|95.0|-70.23|-57.66||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-57.66|-70.23|<0.001
70945017|NCT00943722|141390608|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|1.07|||||TWO_SIDED|95.0|0.95|1.2|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 11||1.20|0.95|
70945018|NCT00943722|141390608|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|1.07|||||TWO_SIDED|95.0|0.95|1.2|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 11||1.20|0.95|
70945019|NCT00943722|141390608|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|0.96|||||TWO_SIDED|95.0|0.86|1.06|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 16||1.06|0.86|
70945020|NCT00943722|141390608|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.0|||||TWO_SIDED|95.0|0.9|1.12|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 16||1.12|0.90|
71086074|NCT02358031|141677688|OTHER||Difference in ORR Percentage|0.5||||0.4586|TWO_SIDED|95.0|-8.2|9.1||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in CPS ≥1 participants of the pembro combo arm was compared to ORR in CPS ≥1 participants of the control arm. The comparison was based on Miettinen \& Nurminen method stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||9.1|-8.2|0.4586
71086075|NCT02358031|141677689|OTHER||Difference in ORR Percentage|5.0||||0.2161|TWO_SIDED|95.0|-7.5|17.4||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in CPS ≥20 participants of the pembro combo arm was compared to ORR in CPS ≥20 participants of the control arm. The comparison was based on Miettinen \& Nurminen method stratified by ECOG (0 vs. 1) and HPV status (Positive vs. Negative).||17.4|-7.5|0.2161
71086076|NCT02358031|141677690|OTHER||Difference in LS Means|0.4||||0.839|TWO_SIDED|95.0|-3.46|4.26||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|constrained Longitudinal Data Analysis|||Change from baseline to Week 15 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro combo arm and the control arm. Comparison based on constrained longitudinal data analysis (cLDA) model with GHS/QoL score as response variable and treatment by visit interaction, stratification factors (ECOG \[0 vs. 1\], HPV status \[Positive vs. Negative\] and PD-L1 TPS status \[Strongly Positive, Not Strongly Positive\]) as covariates.||4.26|-3.46|0.839
71086077|NCT02358031|141677691|OTHER||Hazard Ratio (HR)|1.37||||0.9497|TWO_SIDED|95.0|0.94|2.0||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in GHS/QoL combined score was compared between all participants of the pembro combo arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||2.00|0.94|0.9497
71086078|NCT02358031|141677692|OTHER||Hazard Ratio (HR)|1.37||||0.9476|TWO_SIDED|95.0|0.93|2.02||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in EORTC QLQ-H\&N35 Pain Score was compared between all participants of the pembro combo arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||2.02|0.93|0.9476
71123770|NCT02564978|141753458|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.39|TWO_SIDED|||||Result of statistical analyses were considered significant if the p-value from the one-sided test was \<0.025. No adjustments for multiplicity were made.|Mixed Models Analysis||The estimate was the difference in rates of change in mean of appropriately transformed GA area between the treatment phase and run-in phase.|Analysis: linear spline regression with fixed knot @ Month 9 on study eyes alone. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between treatment phase \& run-in phase \>= 0. Square root transformation used to satisfy the linear trend assumption. Missing values: treated as missing completely at random. Covariance structure of random effect that provided best model fit chosen (Spatial Power). One-sided Type I error rate: 2.5%.||||0.39
71086079|NCT02358031|141677693|OTHER||Hazard Ratio (HR)|1.05||||0.5836|TWO_SIDED|95.0|0.69|1.59||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in EORTC QLQ-H\&N35 Swallowing Score was compared between all participants of the pembro combo arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||1.59|0.69|0.5836
71086080|NCT02358031|141677700|OTHER||Difference in ORR Percentage|-19.0||||1|TWO_SIDED|95.0|-25.8|-12.1||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in all participants of the pembro mono arm was compared to ORR in all participants of the control arm. The comparison was based on Miettinen \& Nurminen method stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive , Not Strongly Positive).||-12.1|-25.8|1.0000
71086081|NCT02358031|141677701|OTHER||Difference in ORR Percentage|-15.9||||1|TWO_SIDED|95.0|-23.4|-8.3||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in CPS ≥1 participants of the pembro mono arm was compared to ORR in CPS ≥1 participants of the control arm. The comparison was based on Miettinen \& Nurminen method stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||-8.3|-23.4|1.0000
71123771|NCT02564978|141753459|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.48|TWO_SIDED|95.0|-0.06|0.03||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on study eyes alone. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.03|-0.06|0.48
70856848|NCT02927067|141200239|NON_INFERIORITY|Non-inferiority (NI) margin of primary efficacy endpoint was 7%. If lower limit of 95% confidence interval (CI) was greater than -7%, NI was assumed. Power calculation: Assuming 68% (maribavir), 60% (valganciclovir) participants achieve confirmed viremia clearance,494 participants (247 per group) would yield \>90% power to declare NI based on 2-group test of equivalence in proportions. Considering 10% dropout,550 participants (275 per group) were planned to be enrolled and randomized.|Difference in Percentage of Responders|-7.7|||||TWO_SIDED|95.0|-14.98|-0.36|||||Cochran-Mantel-Haenszel (CMH) weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for adjusted difference in percentage of responders (Maribavir-Valganciclovir), 95% CI, and p-value.|||-0.36|-14.98|
70856849|NCT02927067|141200240|NON_INFERIORITY|The non-inferiority margin of the key secondary efficacy endpoint was 7%. If the lower limit of the 95% CI was greater than -7%, then noninferiority (NI) was assumed. Because the NI of the primary efficacy endpoint was not established, the NI hypothesis of the key secondary endpoint was not tested formally.|Difference in Percentage of Responders|4.4|||||TWO_SIDED|95.0|-3.91|12.76|||||CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|||12.76|-3.91|
70856850|NCT02927067|141200241|SUPERIORITY||Difference in Percentage of Responders|8.0|||=|0.061|TWO_SIDED|95.0|-0.38|16.3||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||||16.30|-0.38|=0.061
70856851|NCT02927067|141200242|SUPERIORITY||Difference in Percentage of Responders|8.0|||=|0.061|TWO_SIDED|95.0|-0.38|16.3||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 8||16.30|-0.38|=0.061
70856852|NCT02927067|141200242|SUPERIORITY||Difference in Percentage of Responders|13.4|||=|0.001|TWO_SIDED|95.0|5.23|21.62||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 12||21.62|5.23|=0.001
70856853|NCT02927067|141200242|SUPERIORITY||Difference in Percentage of Responders|13.8|||<|0.001|TWO_SIDED|95.0|5.8|21.87||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 16||21.87|5.80|<0.001
70856854|NCT02927067|141200242|SUPERIORITY||Difference in Percentage of Responders|9.7|||=|0.014|TWO_SIDED|95.0|1.98|17.5||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 20||17.50|1.98|=0.014
70856855|NCT02927067|141200243|SUPERIORITY||Difference in Percentage of Responders|-7.3|||=|0.051|TWO_SIDED|95.0|-14.64|0.02||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 8||0.02|-14.64|=0.051
70856856|NCT02927067|141200243|SUPERIORITY||Difference in Percentage of Responders|2.2|||=|0.606|TWO_SIDED|95.0|-6.05|10.37||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 12||10.37|-6.05|=0.606
70945021|NCT00943722|141390608|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.05|||||TWO_SIDED|95.0|0.94|1.17|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 16||1.17|0.94|
70945022|NCT00943722|141390608|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.0|||||TWO_SIDED|95.0|0.89|1.14|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 18||1.14|0.89|
70945023|NCT00943722|141390608|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.11|||||TWO_SIDED|95.0|0.98|1.26|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 18||1.26|0.98|
71086082|NCT02358031|141677702|OTHER||Difference in ORR Percentage|-12.8||||0.9869|TWO_SIDED|95.0|-23.8|-1.5||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in CPS ≥20 participants of the pembro mono arm was compared to ORR in CPS ≥20 participants of the control arm. The comparison was based on Miettinen \& Nurminen method stratified by ECOG (0 vs. 1) and HPV status (Positive vs. Negative).||-1.5|-23.8|0.9869
70945024|NCT00943722|141390608|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.11|||||TWO_SIDED|95.0|0.97|1.26|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 18||1.26|0.97|
71086083|NCT02358031|141677703|OTHER||Difference in LS Means|0.24||||0.893|TWO_SIDED|95.0|-3.34|3.82||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|constrained Longitudinal Data Analysis|||Change from baseline to Week 15 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro mono arm and the control arm. Comparison based on cLDA model with GHS/QoL score as response variable and treatment by visit interaction, stratification factors (ECOG \[0 vs. 1\], HPV status \[Positive vs. Negative\] and PD-L1 TPS status \[Strongly Positive, Not Strongly Positive\]) as covariates.||3.82|-3.34|0.893
70945025|NCT00943722|141390608|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.0|||||TWO_SIDED|95.0|0.89|1.13|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 31||1.13|0.89|
71086084|NCT02358031|141677704|OTHER||Hazard Ratio (HR)|1.38||||0.953|TWO_SIDED|95.0|0.95|2.0||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in GHS/QoL combined score was compared between all participants of the pembro mono arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||2.00|0.95|0.9530
71123772|NCT02564978|141753459|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.15|TWO_SIDED|95.0|-0.24|0.04||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on qualifying fellow eyes alone. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.04|-0.24|0.15
71123773|NCT02564978|141753459|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.15|TWO_SIDED|95.0|-0.09|0.01||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided||No. of units analyzed = no. of study eyes + no. qualifying fellow eyes (QFE). However, the value contributing to analysis is the avg. of study eye \& QFE from a participant if both values are available, otherwise equal to eye with data available.|Analysis: two-sided Student's paired t-test on study and qualifying fellow eyes (Study eye + QFE) together. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.01|-0.09|0.15
71123774|NCT02564978|141753460|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.61|TWO_SIDED|||||Result of statistical analyses were considered significant if the p-value from the one-sided test was \<0.025. No adjustments for multiplicity were made.|Mixed Models Analysis||The estimate was the difference in rates of change in mean of appropriately transformed GA area between the treatment phase and run-in phase.|Analysis: linear spline regression with fixed knot @ Month 9 on study eyes alone. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between treatment phase \& run-in phase \>= 0. Square root transformation used to satisfy the linear trend assumption. Missing values: treated as missing completely at random. Covariance structure of random effect that provided best model fit chosen (Spatial Power). One-sided Type I error rate: 2.5%.||||0.61
71123775|NCT02564978|141753460|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.08||0.43|TWO_SIDED|||||Result of statistical analyses were considered significant if the p-value from the one-sided test was \<0.025. No adjustments for multiplicity were made.|Mixed Models Analysis||The estimate was the difference in rates of change in mean of appropriately transformed GA area between the treatment phase and run-in phase.|Analysis: linear spline regression with fixed knot @ Month 9 on qualifying fellow eyes alone. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between treatment phase \& run-in phase \>= 0. Square root transformation used to satisfy the linear trend assumption. Missing values: treated as missing completely at random. Covariance structure of random effect that provided best model fit chosen (Spatial Power). One-sided Type I error rate: 2.5%.||||0.43
71123776|NCT02564978|141753460|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.89|TWO_SIDED|||||Result of statistical analyses were considered significant if the p-value from the one-sided test was \<0.025. No adjustments for multiplicity were made.|Mixed Models Analysis||Study eye + QFE: study \& qualifying fellow eyes analyzed as separate observations. Estimate: difference in rate of change in mean of appropriately transformed GA area between treatment and run-in phase.|Analysis: linear spline regression with fixed knot @ Month 9 on study and qualifying fellow eyes together. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between treatment phase \& run-in phase \>= 0. Square root transformation used to satisfy the linear trend assumption. Missing values: treated as missing completely at random. Covariance structure of random effect that provided best model fit chosen (Spatial Power). One-sided Type I error rate: 2.5%.||||0.89
71123777|NCT02564978|141753461|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.44|TWO_SIDED|95.0|-0.4|0.9||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on study eyes alone. Null hypothesis: difference in the mean rates of change in BCVA between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.9|-0.4|0.44
71123778|NCT02564978|141753461|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.21|TWO_SIDED|95.0|-0.8|0.2||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on qualifying fellow eyes alone. Null hypothesis: difference in the mean rates of change in BCVA between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.2|-0.8|0.21
71123779|NCT02564978|141753461|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.52|TWO_SIDED|95.0|-0.4|0.8||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided||No. of units analyzed = no. of study eyes + no. qualifying fellow eyes (QFE). However, the value contributing to analysis is the avg. of study eye \& QFE from a participant if both values are available, otherwise equal to eye with data available.|Analysis: two-sided Student's paired t-test on study and qualifying fellow eyes together (Study eye + QFE). Null hypothesis: difference in the mean rates of change in BCVA between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.8|-0.4|0.52
70945026|NCT00943722|141390608|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.02|||||TWO_SIDED|95.0|0.91|1.16|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 31||1.16|0.91|
70945027|NCT00943722|141390608|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.02|||||TWO_SIDED|95.0|0.9|1.15|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 31||1.15|0.90|
70945028|NCT00943722|141390608|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.05|||||TWO_SIDED|95.0|0.94|1.16|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 33||1.16|0.94|
70945029|NCT00943722|141390608|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.05|||||TWO_SIDED|95.0|0.94|1.17|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 33||1.17|0.94|
70945030|NCT00943722|141390608|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.01|||||TWO_SIDED|95.0|0.9|1.12|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 33||1.12|0.90|
71123780|NCT02564978|141753462|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.48|TWO_SIDED|95.0|-0.4|0.9||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on study eyes alone. Null hypothesis: difference in the mean rates of change in LLVA between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.9|-0.4|0.48
71123781|NCT02564978|141753462|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.09|TWO_SIDED|95.0|-0.9|0.1||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on qualifying fellow eyes alone. Null hypothesis: difference in the mean rates of change in LLVA between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.1|-0.9|0.09
71123782|NCT02564978|141753462|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.54|TWO_SIDED|95.0|-0.4|0.7||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided||No. of units analyzed = no. of study eyes + no. qualifying fellow eyes (QFE). However, the value contributing to analysis is the avg. of study eye \& QFE from a participant if both values are available, otherwise equal to eye with data available.|Analysis: two-sided Student's paired t-test on study and qualifying fellow eyes together (Study eye + QFE). Null hypothesis: difference in the mean rates of change in LLVA between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.7|-0.4|0.54
71123783|NCT02564978|141753463|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.2|TWO_SIDED|95.0|-0.4|1.8||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on study eyes alone. Null hypothesis: difference in the mean rate of change of central retinal thickness as measured on OCT between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||1.8|-0.4|0.20
71123784|NCT02564978|141753463|SUPERIORITY||Mean Difference (Final Values)|1.8||||0.02|TWO_SIDED|95.0|0.4|3.1||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on qualifying fellow eyes alone. Null hypothesis: difference in the mean rate of change of central retinal thickness as measured on OCT between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||3.1|0.4|0.02
71123785|NCT02564978|141753463|SUPERIORITY|Number of eyes contributing to this analysis exceeds the number of eyes contributing to the study eye only analysis since one participant had relevant data for the qualifying fellow eye but not the study eye.|Mean Difference (Final Values)|1.0||||0.06|TWO_SIDED|95.0|0.0|2.0||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided||No. of units analyzed = no. of study eyes + no. qualifying fellow eyes (QFE). However, the value contributing to analysis is the avg. of study eye \& QFE from a participant if both values are available, otherwise equal to eye with data available.|Analysis: two-sided Student's paired t-test on study and qualifying fellow eyes together (Study eye + QFE). Null hypothesis: difference in the mean rate of change of central retinal thickness as measured on OCT between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||2.0|0.0|0.06
71123786|NCT01307462|141753534|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based physical functioning score||||.81
71123787|NCT01307462|141753534|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based role-physical score||||.18
71123788|NCT01307462|141753534|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based bodily pain score||||.48
71123789|NCT01307462|141753534|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based general health score||||.26
71123790|NCT01307462|141753534|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based vitality score||||.23
71123791|NCT01307462|141753534|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based social functioning score||||.36
71123792|NCT01307462|141753534|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based role-emotional score||||.41
71123793|NCT01307462|141753534|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based mental health score||||.80
71123794|NCT01307462|141753534|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||SF-36 standardized physical component score||||.80
70945031|NCT00943722|141390608|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|0.84|||||TWO_SIDED|95.0|0.73|0.95|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 45||0.95|0.73|
70945032|NCT00943722|141390608|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.04|||||TWO_SIDED|95.0|0.91|1.18|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 45||1.18|0.91|
71086085|NCT02358031|141677705|OTHER||Hazard Ratio (HR)|0.8||||0.1501|TWO_SIDED|95.0|0.53|1.21||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in EORTC QLQ-H\&N35 Pain Score was compared between all participants of the pembro mono arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||1.21|0.53|0.1501
71123795|NCT01307462|141753534|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||SF-36 standardized mental component score||||.23
70945033|NCT00943722|141390608|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.24|||||TWO_SIDED|95.0|1.08|1.42|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 45||1.42|1.08|
71123796|NCT01307462|141753535|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||FACT physical well-being||||0.28
71123797|NCT01307462|141753535|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||FACT social/family well-being||||0.1
71123798|NCT01307462|141753535|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||FACT emotional well-being||||0.63
71123799|NCT01307462|141753535|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||FACT functional well-being||||0.78
71123800|NCT01307462|141753535|SUPERIORITY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||FACT BMT subscale||||.84
71123801|NCT01307462|141753535|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||FACT trial outcome index||||.37
71123802|NCT01307462|141753535|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||FACT-G||||.71
71123803|NCT01307462|141753535|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||FACT-BMT total||||.54
71123804|NCT01307462|141753536|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||HAP maximum activity score - highest item still doing||||.37
71123805|NCT01307462|141753536|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||HAP adjusted activity score - MAS minus stopped||||.39
71123806|NCT01307462|141753536|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Modified HAP adjusted activity score||||.39
71123807|NCT01307462|141753537|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Lee symptom skin scale||||.11
71123808|NCT01307462|141753537|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||Lee symptom energy scale||||.007
71123809|NCT01307462|141753537|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Lee symptom lung scale||||.20
71123810|NCT01307462|141753537|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Lee symptom eye scale||||.002
71123811|NCT01307462|141753537|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Lee symptom nutrition scale||||.52
71123812|NCT01307462|141753537|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||Lee symptom psychological scale||||.22
71123813|NCT01307462|141753537|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Lee symptom mouth scale||||.002
71123814|NCT01307462|141753537|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Lee symptom overall summary scale||||<0.001
71123815|NCT03875664|141753549|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71123816|NCT04253587|141753560|EQUIVALENCE|The null hypothesis was no difference between mean change scores for time-points X conditions.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.03|=|0.016|TWO_SIDED|95.0|-0.06|0.06||Mixed effects ANOVA applied family wise error for post-hoc tests according to a priori hypothesis|ANOVA|||||0.06|-0.06|= 0.016
71123817|NCT04253587|141753561|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.035|=|0.22|TWO_SIDED|95.0|-0.03|0.03|||ANOVA|effect of condition (F1,20 = 1.616, p = 0.22), effect of time (F1,20 = 0.613, p = 0.44)||||0.03|-0.03|= 0.22
71123818|NCT01885910|141753575|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<.0001
71123819|NCT05160766|141753589|OTHER||Difference of means in percent|12.557|STANDARD_ERROR_OF_MEAN|5.661||0.03143|TWO_SIDED|95.0|1.168|23.946|||ANCOVA|||The statistical analysis reflects Part A of the study.||23.946|1.168|0.03143
71123820|NCT05160766|141753589|OTHER||Difference of means in percent|4.331|STANDARD_ERROR_OF_MEAN|1.671||0.0101|TWO_SIDED|95.0|1.04|7.621|||ANCOVA|||This statistical analysis reflects Part B of the study.||7.621|1.04|0.0101
71123821|NCT05160766|141753590|OTHER||Difference of means in percent|12.168|STANDARD_ERROR_OF_MEAN|5.88||0.04405|TWO_SIDED|95.0|0.338|23.998|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.1.7 (alpha)."|23.998|0.338|0.04405
71123822|NCT05160766|141753590|OTHER||Difference of means in percent|14.212|STANDARD_ERROR_OF_MEAN|5.767||0.01744|TWO_SIDED|95.0|2.61|25.814|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.351 (beta)."|25.814|2.61|0.01744
71123823|NCT05160766|141753590|OTHER||Difference of means in percent|14.239|STANDARD_ERROR_OF_MEAN|5.932||0.02039|TWO_SIDED|95.0|2.305|26.173|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant P.1 (gamma)."|26.173|2.305|0.02039
71123824|NCT05160766|141753590|OTHER||Difference of means in percent|9.331|STANDARD_ERROR_OF_MEAN|4.636||0.04989|TWO_SIDED|95.0|0.005|18.656|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.1 (omicron)."|18.656|0.005|0.04989
71123825|NCT05160766|141753590|OTHER||Difference of means in percent|10.312|STANDARD_ERROR_OF_MEAN|4.373||0.02259|TWO_SIDED|95.0|1.514|19.111|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.4 (omicron)."|19.111|1.514|0.02259
71123826|NCT05160766|141753590|OTHER||Difference of means in percent|11.601|STANDARD_ERROR_OF_MEAN|4.634||0.01583|TWO_SIDED|95.0|2.279|20.924|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.4.6 (omicron)."|20.924|2.279|0.01583
70945034|NCT00943722|141390608|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|0.92|||||TWO_SIDED|95.0|0.83|1.03|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 52||1.03|0.83|
70945035|NCT00943722|141390608|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|0.95|||||TWO_SIDED|95.0|0.85|1.07|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 52||1.07|0.85|
70945036|NCT00943722|141390608|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.03|||||TWO_SIDED|95.0|0.92|1.16|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 52||1.16|0.92|
70945037|NCT00943722|141390608|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|0.95|||||TWO_SIDED|95.0|0.86|1.06|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 58||1.06|0.86|
70856857|NCT02927067|141200243|SUPERIORITY||Difference in Percentage of Responders|1.0|||=|0.809|TWO_SIDED|95.0|-7.27|9.31||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 20||9.31|-7.27|=0.809
70856858|NCT01727700|141200264|SUPERIORITY_OR_OTHER||Treatment difference|-6.26||||0.002|TWO_SIDED|95.0|-10.18|-2.34||The Hochberg procedure was used to adjust for multiplicity.|Mixed Models Analysis|Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.||Assuming 5% of participants may drop out of the trial without a postbaseline efficacy evaluation, a total of 126 participants were required to provide at least 80% power to detect a treatment difference of -5 (common standard deviation \[SD\] of 8.5) between at least 1 of 2 aripiprazole dose levels and placebo in the primary outcome.||-2.34|-10.18|0.0020
70856859|NCT01727700|141200264|SUPERIORITY_OR_OTHER||Treatment difference|-9.85|||<|0.0001|TWO_SIDED|95.0|-13.84|-5.86||The Hochberg procedure was used to adjust for multiplicity.|Mixed Models Analysis|Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.||Assuming 5% of participants may drop out of the trial without a postbaseline efficacy evaluation, a total of 126 participants were required to provide at least 80% power to detect a treatment difference of -5 (common standard SD of 8.5) between at least 1 of 2 aripiprazole dose levels and placebo in the primary outcome.||-5.86|-13.84|<0.0001
70856860|NCT01727700|141200265|SUPERIORITY_OR_OTHER||Treatment difference|-1.03||||0.0001|TWO_SIDED|95.0|-1.54|-0.52||The Hochberg procedure was used to adjust for multiplicity.|Mixed Models Analysis|Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.||||-0.52|-1.54|0.0001
70856861|NCT01727700|141200265|SUPERIORITY_OR_OTHER||Treatment difference|-1.02||||0.0002|TWO_SIDED|95.0|-1.54|-0.49||The Hochberg procedure was used to adjust for multiplicity.|Mixed Models Analysis|Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.||||-0.49|-1.54|0.0002
70856862|NCT01727700|141200266|SUPERIORITY_OR_OTHER||Treatment difference|-13.26||||0.0017|TWO_SIDED|95.0|-21.43|-5.08||Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.|Mixed Models Analysis|||||-5.08|-21.43|0.0017
71086086|NCT02358031|141677706|OTHER||Hazard Ratio (HR)|1.26||||0.8751|TWO_SIDED|95.0|0.85|1.88||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in EORTC QLQ-H\&N35 Swallowing Score was compared between all participants of the pembro mono arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||1.88|0.85|0.8751
70945038|NCT00943722|141390608|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.07|||||TWO_SIDED|95.0|0.96|1.2|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 58||1.20|0.96|
71123827|NCT05160766|141753590|OTHER||Difference of means in percent|11.863|STANDARD_ERROR_OF_MEAN|4.323||0.00856|TWO_SIDED|95.0|3.166|20.56|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.5 (omicron)."|20.56|3.166|0.00856
71123828|NCT05160766|141753590|OTHER||Difference of means in percent|6.83|STANDARD_ERROR_OF_MEAN|2.244||0.00258|TWO_SIDED|95.0|2.41|11.249|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.1.7 (alpha)."|11.249|2.41|0.00258
71123829|NCT05160766|141753590|OTHER||Difference of means in percent|6.048|STANDARD_ERROR_OF_MEAN|2.244||0.00748|TWO_SIDED|95.0|1.63|10.466|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.351 (beta)."|10.466|1.63|0.00748
71123830|NCT05160766|141753590|OTHER||Difference of means in percent|7.302|STANDARD_ERROR_OF_MEAN|2.782||0.00922|TWO_SIDED|95.0|1.821|12.782|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant P.1 (gamma)."|12.782|1.821|0.00922
71123831|NCT05160766|141753590|OTHER||Difference of means in percent|4.791|STANDARD_ERROR_OF_MEAN|2.646||0.07136|TWO_SIDED|95.0|-0.419|10.001|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.1 (omicron)."|10.001|-0.419|0.07136
71123832|NCT05160766|141753590|OTHER||Difference of means in percent|3.965|STANDARD_ERROR_OF_MEAN|2.196||0.07218|TWO_SIDED|95.0|-0.36|8.29|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.4 (omicron)."|8.29|-0.36|0.07218
71123833|NCT05160766|141753590|OTHER||Difference of means in percent|4.82|STANDARD_ERROR_OF_MEAN|2.202||0.02949|TWO_SIDED|95.0|0.484|9.155|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.4.6 (omicron)."|9.155|0.484|0.02949
71123834|NCT05160766|141753590|OTHER||Difference of means in percent|3.926|STANDARD_ERROR_OF_MEAN|2.263||0.08403|TWO_SIDED|95.0|-0.531|8.382|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.5 (omicron)."|8.382|-0.531|0.08403
71123835|NCT05160766|141753593|OTHER||Difference of means in percent|8.835|STANDARD_ERROR_OF_MEAN|11.03||0.42797|TWO_SIDED|95.0|-13.475|31.145|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.1.7 (alpha)."|31.145|-13.475|0.42797
71123836|NCT05160766|141753593|OTHER||Difference of means in percent|3.54|STANDARD_ERROR_OF_MEAN|10.575||0.73961|TWO_SIDED|95.0|-17.85|24.929|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.351 (beta)."|24.929|-17.85|0.73961
71123837|NCT05160766|141753593|OTHER||Difference of means in percent|8.086|STANDARD_ERROR_OF_MEAN|10.683||0.4537|TWO_SIDED|95.0|-13.524|29.695|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant P.1 (gamma)."|29.695|-13.524|0.45370
71123838|NCT05160766|141753593|OTHER||Difference of means in percent|1.636|STANDARD_ERROR_OF_MEAN|10.187||0.87323|TWO_SIDED|95.0|-18.969|22.241|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.1 (omicron)."|22.241|-18.969|0.87323
70856863|NCT01727700|141200266|SUPERIORITY_OR_OTHER||Treatment difference|-19.37|||<|0.0001|TWO_SIDED|95.0|-27.7|-11.04||Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.|Mixed Models Analysis|||||-11.04|-27.70|<0.0001
70856864|NCT01727700|141200267|SUPERIORITY_OR_OTHER||Treatment difference|-0.8||||0.001|TWO_SIDED|95.0|-1.27|-0.33||Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.|Mixed Models Analysis|||||-0.33|-1.27|0.0010
70856865|NCT01727700|141200267|SUPERIORITY_OR_OTHER||MMRM|-0.92||||0.0002|TWO_SIDED|95.0|-1.41|-0.44||Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.|Mixed Models Analysis|||||-0.44|-1.41|0.0002
70856866|NCT01727700|141200268|SUPERIORITY_OR_OTHER||Response ratio|1.36||||0.0835|TWO_SIDED|95.0|0.98|1.88||P-value derived from Cochran-Mantel-Haenszel (CMH) General Association Test adjusting for region and weight group.|Cochran-Mantel-Haenszel|Response ratio \> 1 favors aripiprazole.||||1.88|0.98|0.0835
70856867|NCT01727700|141200268|SUPERIORITY_OR_OTHER||Response ratio|1.61||||0.0014|TWO_SIDED|95.0|1.2|2.16||P-value derived from CMH General Association Test adjusting for region and weight group.|Cochran-Mantel-Haenszel|Response ratio \> 1 favors aripiprazole.||||2.16|1.20|0.0014
70856868|NCT01727700|141200269|SUPERIORITY_OR_OTHER||Discontinuation ratio|1.16||||0.9187|TWO_SIDED|95.0|0.19|7.05||Discontinuation ratio \< 1 favors aripiprazole. P-value derived from CMH General Association Test adjusting for region and weight group.|Cochran-Mantel-Haenszel|||||7.05|0.19|0.9187
71123839|NCT05160766|141753593|OTHER||Difference of means in percent|0.81|STANDARD_ERROR_OF_MEAN|9.848||0.93489|TWO_SIDED|95.0|-19.109|20.728|||ANCOVA|||This statistical analysis relfects Part A of the study.|"The above provided values refer to the variant BA.4 (omicron)."|20.728|-19.109|0.93489
71123840|NCT05160766|141753593|OTHER||Difference of means in percent|3.511|STANDARD_ERROR_OF_MEAN|10.845||0.74784|TWO_SIDED|95.0|-18.425|25.448|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.4.6 (omicron)."|25.448|-18.425|0.74784
71123841|NCT05160766|141753593|OTHER||Difference of means in percent|2.088|STANDARD_ERROR_OF_MEAN|10.409||0.84202|TWO_SIDED|95.0|-18.966|23.143|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.5 (omicron)."|23.143|-18.966|0.84202
71123842|NCT05160766|141753593|OTHER||Difference of means in percent|5.807|STANDARD_ERROR_OF_MEAN|4.068||0.15477|TWO_SIDED|95.0|-2.207|13.821|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.1.7 (alpha)."|13.821|-2.207|0.15477
71123843|NCT05160766|141753593|OTHER||Difference of means in percent|3.52|STANDARD_ERROR_OF_MEAN|3.984||0.37773|TWO_SIDED|95.0|-4.327|11.368|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.351 (beta)."|11.368|-4.327|0.37773
71123844|NCT05160766|141753593|OTHER||Difference of means in percent|4.413|STANDARD_ERROR_OF_MEAN|4.18||0.29212|TWO_SIDED|95.0|-3.821|12.647|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant P.1 (gamma)."|12.647|-3.821|0.29212
71123845|NCT05160766|141753593|OTHER||Difference of means in percent|5.961|STANDARD_ERROR_OF_MEAN|4.04||0.1414|TWO_SIDED|95.0|-1.998|13.919|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.1 (omicron)."|13.919|-1.998|0.14140
71123846|NCT05160766|141753593|OTHER||Difference of means in percent|2.199|STANDARD_ERROR_OF_MEAN|3.875||0.5709|TWO_SIDED|95.0|-5.434|9.832|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.4 (omicron)."|9.832|-5.434|0.57090
71123847|NCT05160766|141753593|OTHER||Difference of means in percent|6.528|STANDARD_ERROR_OF_MEAN|4.071||0.11012|TWO_SIDED|95.0|-1.491|14.548|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.4.6 (omicron)."|14.548|-1.491|0.11012
71123848|NCT05160766|141753593|OTHER||Difference of means in percent|4.239|STANDARD_ERROR_OF_MEAN|4.06||0.29755|TWO_SIDED|95.0|-3.759|12.237|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.5 (omicron)."|12.237|-3.759|0.29755
71123849|NCT05160766|141753598|OTHER||Difference of means in percent|9.64|STANDARD_ERROR_OF_MEAN|11.191||0.39426|TWO_SIDED|95.0|-12.995|32.275|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant P.2 (gamma)."|32.275|-12.995|0.39426
71123850|NCT05160766|141753598|OTHER||Difference of means in percent|8.764|STANDARD_ERROR_OF_MEAN|10.765||0.42055|TWO_SIDED|95.0|-13.011|30.539|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.617."|30.539|-13.011|0.42055
71123851|NCT05160766|141753598|OTHER||Difference of means in percent|8.472|STANDARD_ERROR_OF_MEAN|10.953||0.44391|TWO_SIDED|95.0|-13.683|30.627|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.617.1 (kappa)."|30.627|-13.683|0.44391
71123852|NCT05160766|141753598|OTHER||Difference of means in percent|8.483|STANDARD_ERROR_OF_MEAN|10.82||0.43775|TWO_SIDED|95.0|-13.402|30.368|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant AY.3 (delta)."|30.368|-13.402|0.43775
71123853|NCT05160766|141753598|OTHER||Difference of means in percent|6.19|STANDARD_ERROR_OF_MEAN|9.892||0.53511|TWO_SIDED|95.0|-13.819|26.2|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant AY.4.2 (delta)."|26.2|-13.819|0.53511
70856869|NCT01727700|141200269|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.9576||||||Hazard ratio \< 1 favors aripiprazole. P-value derived from Cox proportional hazard regression adjusting for region and weight group.|Regression, Cox|||||||0.9576
70856870|NCT01727700|141200269|SUPERIORITY_OR_OTHER||Discontinuation ratio|4.06||||0.0132|TWO_SIDED|95.0|1.1|14.95||Discontinuation ratio \< 1 favors aripiprazole. P-value derived from CMH General Association Test adjusting for region and weight group.|Cochran-Mantel-Haenszel|||||14.95|1.10|0.0132
71123854|NCT05160766|141753598|OTHER||Difference of means in percent|4.552|STANDARD_ERROR_OF_MEAN|10.801||0.67576|TWO_SIDED|95.0|-17.295|26.399|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.617.3."|26.399|-17.295|0.67576
71123855|NCT05160766|141753598|OTHER||Difference of means in percent|8.438|STANDARD_ERROR_OF_MEAN|11.168||0.45443|TWO_SIDED|95.0|-14.15|31.027|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.526.1 (iota)."|31.027|-14.15|0.45443
70945039|NCT00943722|141390608|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.12|||||TWO_SIDED|95.0|1.0|1.26|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 58||1.26|1.00|
70945040|NCT00943722|141390612|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.1|||<|0.001|TWO_SIDED|95.0|-0.8|1.5|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 6||1.5|-0.8|< 0.001
71086087|NCT03101150|141677713|OTHER|A sample size of minimum 152 was calculated to be able to determine incidence of preeclampsia that is in the range of 8-17% with 80% power assuming an alpha of 5%.|Risk Ratio (RR)|0.163|||<|0.05|TWO_SIDED|95.0|0.02|1.32|||Chi-squared|||Eligible and consented study subjects were randomized according to permuted block design scheme to be allocated in 400 IU arm and 4000 IU arm.||1.32|0.02|<0.05
71086088|NCT03101150|141677714|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71086089|NCT03101150|141677715|OTHER||Risk Ratio (RR)|0.43|||<|0.02|TWO_SIDED|95.0|0.19|0.94|||Chi-squared|||||0.94|0.19|<0.02
71086090|NCT03163446|141677717|OTHER|Statistics considered descriptive as study designed to provide proof of concept and initial assessment of efficacy; not considered confirmatory.|Risk Difference (RD)|10.4||||0.3137|TWO_SIDED|90.0|-6.35|27.19|||Fisher Exact|||||27.19|-6.35|0.3137
71086091|NCT03163446|141677727|OTHER|P-value was ad hoc. Statistics considered descriptive as study designed to provide proof of concept and initial assessment of efficacy; not considered confirmatory.|Risk Difference (RD)|42.8||||0.0101|TWO_SIDED|90.0|14.3|71.4|||Fisher Exact|||||71.4|14.3|0.0101
71086092|NCT03163446|141677728|OTHER|P value was ad hoc. Descriptive statistics were performed.||||||0.0646|||||||Fisher Exact||||Descriptive statistics were performed.|||0.0646
71086093|NCT03163446|141677730|OTHER|P-value was ad hoc. Statistics considered descriptive as study designed to provide proof of concept and initial assessment of efficacy; not considered confirmatory.|Risk Difference (RD)|-21.3||||0.0556|TWO_SIDED|90.0|-45.1|2.5|||Fisher Exact|||||2.5|-45.1|0.0556
71086094|NCT01228591|141677752|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is assessed with a margin of -0.05logMAR.|Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.0059|||TWO_SIDED|95.0|-0.0044|0.0187|||Mixed Models Analysis||The mean difference is defined by: Test lens (Acuvue Advance Plus) - control lens (Acuvue Advance)|"For Low Luminance/ High Contrast grouping (Monocular):~Ho: The test lens (Acuvue Advance Plus) will be non-inferior to the control lens (Acuvue Advance).~Ha: The test lens (Acuvue Advance Plus) will be \<= to the control lens (Acuvue Advance)."||0.0187|-0.0044|
71086095|NCT01228591|141677752|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is assessed with a margin of -0.05 logMAR.|Mean Difference (Final Values)|0.003|STANDARD_ERROR_OF_MEAN|0.0059|||TWO_SIDED|95.0|-0.0086|0.0146|||Mixed Models Analysis||The mean difference is defined by: Test lens (Acuvue Advance Plus) - control lens (Acuvue Advance)|"High Luminance/ Low Contrast grouping (Binocular):~Ho: The test lens (Acuvue Advance Plus) will be non-inferior to the control lens (Acuvue Advance).~Ha: The test lens (Acuvue Advance Plus) will be \<= to the control lens (Acuvue Advance)."||0.0146|-0.0086|
71086096|NCT01228591|141677753|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is assessed with a margin of -0.05 logMAR.|Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.0061|||TWO_SIDED|95.0|0.0041|0.0282|||Mixed Models Analysis||Mean difference represents: Test lens (Advance Plus) - Control lens (Advance).|"For Low Luminance/ High Contrast Grouping (Monocular):~Ho: The test lens (Advance Plus) will be non-inferior to the control lens (Advance).~Ha: The test lens (Advance Plus) will be \<= to the control lens (Advance)."||0.0282|0.0041|
71086097|NCT01228591|141677753|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is assessed with a margin of -0.05 logMAR.|Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.009|0.3305|||Mixed Models Analysis||Mean Difference is defined to be: test lens (Advance Plus) - control lens (Advance).|"For High Luminance/ Low Contrast Grouping (Binocular):~Ho: The test lens (Advance Plus) will be non-inferior from the control lens (Advance).~Ha: The test lens (Advance Plus) will be \<= to the control lens (Advance)."||0.3305|0.0090|
71086098|NCT01298700|141677758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7||||0.148|TWO_SIDED|95.0|-11.0|1.9||P-value was stratified by baseline prostaglandin analogue (PGA) treatment(yes/no) and by baseline active ocular surface finding (present/absent).|Cochran-Mantel-Haenszel||bimatoprost 0.01% ophthalmic solution - bimatoprost 0.03% ophthalmic solution|||1.9|-11|0.148
70856871|NCT01727700|141200269|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.51||||0.0278||||||Hazard ratio \< 1 favors aripiprazole. P-value derived from Cox proportional hazard regression adjusting for region and weight group.|Regression, Cox|||||||0.0278
71123856|NCT05160766|141753598|OTHER||Difference of means in percent|8.901|STANDARD_ERROR_OF_MEAN|10.218||0.38904|TWO_SIDED|95.0|-11.768|29.569|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.2+L452M (omicron)."|29.569|-11.768|0.38904
70945041|NCT00943722|141390612|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 11||1.2|-0.7|< 0.001
70945042|NCT00943722|141390612|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 16||1.2|-0.7|< 0.001
71086099|NCT00129441|141677760|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||||||0.16
71086100|NCT00129441|141677761|SUPERIORITY_OR_OTHER|||||||0.162||95.0|||||ANOVA|||||||0.162
71086101|NCT00129441|141677762|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||ANOVA|||||||0.12
71086102|NCT00129441|141677763|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.05
71086103|NCT00129441|141677764|SUPERIORITY_OR_OTHER|||||||0.249||95.0|||||ANOVA|||||||0.249
71086104|NCT00129441|141677765|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANOVA|||At week 4, mean BPRS total scores were nearly the same for the placebo group and L-830982 group as a result of a significant reduction in positive symptoms reported for the placebo group (F=9.12, df=1,13, p=0.01). For the L-830982-treated group, neither total BPRS scores nor any of the factor scores changed over the course of the trial.||||0.01
70945043|NCT00943722|141390612|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.1|||<|0.001|TWO_SIDED|95.0|-0.8|1.5|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 18||1.5|-0.8|< 0.001
70945044|NCT00943722|141390612|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.7|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 31||1.7|-0.4|< 0.001
71086105|NCT00129441|141677766|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71086106|NCT00129441|141677767|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71086107|NCT00643760|141677779|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|-0.35||||0.295||95.0|-1.02|0.31||This p-value has been adjusted for multiplicity using a combination of a sequential method and the Hochberg procedure in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) model with body mass index (BMI), baseline 24-hour average pain intensity, and grouped center as covariates was used.||||0.31|-1.02|0.295
71086108|NCT00643760|141677779|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|-0.02||||0.946||95.0|-0.71|0.66||This p-value has been adjusted for multiplicity using a combination of a sequential method and the Hochberg procedure in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|An ANCOVA model with BMI, baseline 24-hour average pain intensity, and grouped center as covariates was used.||||0.66|-0.71|0.946
71086109|NCT00643760|141677779|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|-0.55||||0.105||95.0|-1.1|0.01||This p-value has been adjusted for multiplicity using a combination of a sequential method and the Hochberg procedure in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|An ANCOVA model with BMI, baseline 24-hour average pain intensity, and grouped center as covariates was used.||||0.01|-1.10|0.105
71086110|NCT00643760|141677779|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|0.43||||||95.0|-0.22|1.08||||||||1.08|-0.22|
71086111|NCT03934216|141677798|SUPERIORITY||Odds Ratio (OR)|0.9||||0.5935|TWO_SIDED|95.0|0.3|2.4|||Stratified Cochran-Mantel-Haenszel|||||2.4|0.3|0.5935
71086112|NCT03934216|141677799|SUPERIORITY||Odds Ratio (OR)|1.2||||0.3051|TWO_SIDED|95.0|0.6|2.7|||Stratified Cochran-Mantel-Haenszel|||||2.7|0.6|0.3051
71086113|NCT03934216|141677800|SUPERIORITY||Odds Ratio (OR)|0.6||||0.8764|TWO_SIDED|95.0|0.3|1.4|||Stratified Cochran-Mantel-Haenszel|||||1.4|0.3|0.8764
71086114|NCT03934216|141677801|SUPERIORITY||Odds Ratio (OR)|1.4||||0.2235|TWO_SIDED|95.0|0.5|3.8|||Stratified Cochran-Mantel-Haenszel|||||3.8|0.5|0.2235
71086115|NCT00048035|141677810|SUPERIORITY_OR_OTHER||Estimated Conversion Factor 90% CI|0.38|||||TWO_SIDED|90.0|0.32|0.42|||||To analyze the appropriateness of the chosen dose conversion factors, a second regression analysis was carried out. This was a regression on the three different conversion factor dose groups, using the regression slope estimates of Hb.|All cohorts with dosing frequency 1 X / Week||0.42|0.32|
71086116|NCT00048035|141677810|SUPERIORITY_OR_OTHER||Estimated Conversion Factor 90% CI|0.61|||||TWO_SIDED|90.0|0.53|0.76|||||To analyze the appropriateness of the chosen dose conversion factors, a second regression analysis was carried out. This was a regression on the three different conversion factor dose groups, using the regression slope estimates of Hb change.|All cohorts with dosing frequency 1 X /2 Week||0.76|0.53|
71086117|NCT03677635|141677873|OTHER||Standardised Effect Size|0.32|||||TWO_SIDED|95.0|0.21|0.86|||Standardised Effect Size|||||.86|.21|
71086118|NCT03677635|141677874|OTHER|Cohen's d was reported.|Mean Difference (Final Values)|-0.05|||||TWO_SIDED|95.0|-0.59|0.48|||Standardised Effect Size|||||.48|-.59|
71086119|NCT02157519|141677909|SUPERIORITY||Odds Ratio (OR)|0.56||||0.186|TWO_SIDED|95.0|0.23|1.33||threshold p \<0.05|Regression, Logistic|Adjusted for baseline MMAS-4 scores (dichotomous) and change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the number of participants who self-reported adherence problems (i.e., dichotomous MMAS-4 scores) at post-assessment between groups adjusting for baseline self-reported adherence (i.e., dichotomous MMAS-4 scores) and change in perceived social support (MSPSS) from baseline to post-assessment.||1.33|0.23|0.186
71086120|NCT02157519|141677910|SUPERIORITY||Mean Difference (Final Values)|-2.34|STANDARD_ERROR_OF_MEAN|4.06||0.57|TWO_SIDED|95.0|-10.35|5.68||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the percentage of medication taken (as recorded by MEMS) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||5.68|-10.35|0.57
71086121|NCT02157519|141677911|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.21||0.603|TWO_SIDED|95.0|-0.31|0.53||threshold p \<0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in symptom severity (MDASI-severity) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.53|-0.31|0.603
71086122|NCT02157519|141677911|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.33||0.982|TWO_SIDED|95.0|-0.64|0.65||threshold p \<0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in symptom interference (MDASI-interference) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post assessment.||0.65|-0.64|0.982
71123857|NCT05160766|141753598|OTHER||Difference of means in percent|7.302|STANDARD_ERROR_OF_MEAN|10.11||0.47466|TWO_SIDED|95.0|-13.147|27.751|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.2+L452R (omicron)."|27.751|-13.147|0.47466
71123858|NCT05160766|141753598|OTHER||Difference of means in percent|2.878|STANDARD_ERROR_OF_MEAN|9.824||0.7711|TWO_SIDED|95.0|-16.993|22.749|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.2.12.1 (omicron)."|22.749|-16.993|0.77110
70945045|NCT00943722|141390612|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.6|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 33||1.6|-0.4|< 0.001
71086123|NCT02157519|141677912|SUPERIORITY||Mean Difference (Final Values)|-2.42|STANDARD_ERROR_OF_MEAN|1.65||0.144|TWO_SIDED|95.0|-5.66|0.83||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in overall QOL (FACT-G) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.83|-5.66|0.144
70856872|NCT02519855|141200270|NON_INFERIORITY_OR_EQUIVALENCE|A lower bound of the 95% CI on the fold difference (GMT ratio \[Concomitant / Nonconcomitant\] at 4 weeks postvaccination) \>0.67 implied that the difference is statistically significantly noninferior to the prespecified clinically relevant decrease of 1.5-fold. A p-value ≤0.025 also supported a conclusion of noninferiority.|GMT Ratio at 4 weeks postvaccination|0.87|||<|0.001|TWO_SIDED|95.0|0.8|0.95|||Longitudinal regression model|GMT ratio, 95% CI and p-value were based on a longitudinal regression model adjusting for prevaccination titers and age.||||0.95|0.80|<0.001
70856873|NCT02519855|141200271|SUPERIORITY_OR_OTHER||GMFR from Baseline|1.9|||<|0.001|TWO_SIDED|95.0|1.76|2.05||A lower bound of the 95% CI on the GMFR \> 1.4 indicated that the Concomitant Group induces an acceptable VZV antibody response. A p-value ≤0.025 also supported this conclusion.|Longitudinal regression||Estimated GMFR, 95% CI and p-value were based on a longitudinal regression model adjusting for age.|||2.05|1.76|<0.001
71086124|NCT02157519|141677912|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.66||0.294|TWO_SIDED|95.0|-2.0|0.61||threshold p \<0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in physical QOL (FACT-Physical Well-Being) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) baseline from baseline to post-assessment.||0.61|-2.00|0.294
70856874|NCT02519855|141200272|NON_INFERIORITY_OR_EQUIVALENCE|A lower bound of the 95% CI on the fold difference (GMT ratio \[Concomitant / Nonconcomitant\] at 4 weeks postvaccination) \>0.67 implied that the difference is statistically significantly noninferior to the prespecified clinically relevant decrease of 1.5-fold. A p-value ≤0.025 also supported the conclusion of noninferiority.|GMT Ratio at 4 weeks postvaccination|1.02|||<|0.001|TWO_SIDED|95.0|0.88|1.18|||Longitudinal regression|GMT ratio, 95% CI and p-value were based on a longitudinal regression model adjusting for prevaccination titers and age.||||1.18|0.88|<0.001
70945046|NCT00943722|141390612|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.4|||<|0.001|TWO_SIDED|95.0|-0.6|1.8|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 45||1.8|-0.6|< 0.001
70945047|NCT00943722|141390612|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.7|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 52||1.7|-0.4|< 0.001
70945048|NCT00943722|141390612|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 58||1.2|-0.7|< 0.001
70945049|NCT00943722|141390613|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.1|||<|0.001|TWO_SIDED|95.0|-0.7|1.5|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 6||1.5|-0.7|< 0.001
71086125|NCT02157519|141677912|SUPERIORITY||Mean Difference (Final Values)|-1.67|STANDARD_ERROR_OF_MEAN|0.74||0.025|TWO_SIDED|95.0|-3.12|-0.21||threshold p \<0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in social QOL (FACT-Social Well-Being) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||-0.21|-3.12|0.025
71086126|NCT02157519|141677912|SUPERIORITY||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.58||0.392|TWO_SIDED|95.0|-0.64|1.63||threshold p \<0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in emotional QOL (FACT-Emotional Well-Being) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||1.63|-0.64|0.392
71086127|NCT02157519|141677912|SUPERIORITY||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.6||0.216|TWO_SIDED|95.0|-1.94|0.44||threshold p \<0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in functional QOL (FACT-Functional Well-Being) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.44|-1.94|0.216
71086128|NCT02157519|141677913|SUPERIORITY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.28||0.17|TWO_SIDED|95.0|-0.93|0.17||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post assessment||Analysis comparing change in treatment satisfaction with clinician explanations (FACIT-TS-PS-Clinician Explanations) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.17|-0.93|0.170
71086129|NCT02157519|141677913|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.18||0.057|TWO_SIDED|95.0|-0.72|0.01||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post assessment||Analysis comparing change in satisfaction with interpersonal treatment (FACIT-TS-PS Interpersonal Treatment) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.01|-0.72|0.057
71086130|NCT02157519|141677913|SUPERIORITY||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.72||0.178|TWO_SIDED|95.0|-2.39|0.45||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing change in treatment satisfaction with comprehensive care (FACIT-TS-PS Comprehensive Care) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.45|-2.39|0.178
70945050|NCT00943722|141390613|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 11||1.2|-0.7|< 0.001
70945051|NCT00943722|141390613|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 16||1.2|-0.7|< 0.001
71123859|NCT05160766|141753598|OTHER||Difference of means in percent|1.753||||0.86646|TWO_SIDED|95.0|-19.195|22.701|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.2.75 (omicron)."|22.701|-19.195|0.86646
71123860|NCT05160766|141753598|OTHER||Difference of means in percent|5.42|STANDARD_ERROR_OF_MEAN|9.705||0.57972|TWO_SIDED|95.0|-14.21|25.049|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.2.75.2 (omicron)."|25.049|-14.21|0.57972
71123861|NCT05160766|141753598|OTHER||Difference of means in percent|1.17|STANDARD_ERROR_OF_MEAN|9.408||0.90166|TWO_SIDED|95.0|-17.859|20.199|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.3 (omicron)."|20.199|-17.859|0.90166
70945052|NCT00943722|141390613|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.6|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 18||1.6|-0.4|< 0.001
70945053|NCT00943722|141390613|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.7|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 31||1.7|-0.4|< 0.001
70945054|NCT00943722|141390613|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.6|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 33||1.6|-0.4|< 0.001
70856875|NCT02519855|141200273|NON_INFERIORITY_OR_EQUIVALENCE|A lower bound of the 95% CI on the fold difference (GMT ratio \[Concomitant / Nonconcomitant\] at 4 weeks postvaccination) \>0.67 implied that the difference is statistically significantly noninferior to the prespecified clinically relevant decrease of 1.5-fold. A p-value ≤0.025 also supported the conclusion of noninferiority.|GMT Ratio at 4 weeks postvaccination|1.1|||<|0.001|TWO_SIDED|95.0|0.94|1.29|||Longitudinal regression|GMT ratio, 95% CI and p-value were based on a longitudinal regression model adjusting for prevaccination titers and age.||||1.29|0.94|<0.001
70945055|NCT00943722|141390613|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.5|||<|0.001|TWO_SIDED|95.0|-0.1|2.0|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 45||2.0|-0.1|< 0.001
70945056|NCT00943722|141390613|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.7|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 52||1.7|-0.4|< 0.001
70945057|NCT00943722|141390613|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 58||1.2|-0.7|< 0.001
70945058|NCT00943722|141390614|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.9|0.9|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 6||0.9|-0.9|
70945059|NCT00943722|141390614|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.5|||||TWO_SIDED|95.0|-0.4|1.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 6||1.7|-0.4|
71123862|NCT05160766|141753598|OTHER||Difference of means in percent|1.018|STANDARD_ERROR_OF_MEAN|10.44||0.92279|TWO_SIDED|95.0|-20.099|22.136|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BF.7 (omicron)."|22.136|-20.099|0.92279
71123863|NCT05160766|141753598|OTHER||Difference of means in percent|3.532|STANDARD_ERROR_OF_MEAN|9.496||0.71191|TWO_SIDED|95.0|-15.675|22.74|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BQ.1 (omicron)."|22.74|-15.675|0.71191
71123864|NCT05160766|141753598|OTHER||Difference of means in percent|2.995|STANDARD_ERROR_OF_MEAN|8.755||0.73415|TWO_SIDED|95.0|-14.714|20.703|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BQ.1.1 (omicron)."|20.703|-14.714|0.73415
71123865|NCT05160766|141753598|OTHER||Difference of means in percent|7.157|STANDARD_ERROR_OF_MEAN|9.548||0.45798|TWO_SIDED|95.0|-12.155|26.469|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant XBB.1 (omicron)."|26.469|-12.155|0.45798
71123866|NCT05160766|141753598|OTHER||Difference of means in percent|4.819|STANDARD_ERROR_OF_MEAN|4.055||0.23582|TWO_SIDED|95.0|-3.169|12.808|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant P.2 (gamma)."|12.808|-3.169|0.23582
71123867|NCT05160766|141753598|OTHER||Difference of means in percent|5.312|STANDARD_ERROR_OF_MEAN|4.074||0.19354|TWO_SIDED|95.0|-2.713|13.337|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.617."|13.337|-2.713|0.19354
71123868|NCT05160766|141753598|OTHER||Difference of means in percent|5.714|STANDARD_ERROR_OF_MEAN|4.155||0.17033|TWO_SIDED|95.0|-2.471|13.899|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.617.1 (kappa)."|13.899|-2.471|0.17033
71123869|NCT05160766|141753598|OTHER||Difference of means in percent|5.934|STANDARD_ERROR_OF_MEAN|3.997||0.13895|TWO_SIDED|95.0|-1.94|13.808|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant AY.3 (delta)."|13.808|-1.94|0.13895
71123870|NCT05160766|141753598|OTHER||Difference of means in percent|4.222|STANDARD_ERROR_OF_MEAN|3.812||0.26924|TWO_SIDED|95.0|-3.288|11.732|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant AY.4.2 (delta)."|11.732|-3.288|0.26924
71123871|NCT05160766|141753598|OTHER||Difference of means in percent|5.49|STANDARD_ERROR_OF_MEAN|3.996||0.1708|TWO_SIDED|95.0|-2.382|13.362|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.617.3."|13.362|-2.382|0.17080
71123872|NCT05160766|141753598|OTHER||Difference of means in percent|5.567|STANDARD_ERROR_OF_MEAN|4.188||0.18502|TWO_SIDED|95.0|-2.683|13.818|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.526.1 (iota)."|13.818|-2.683|0.18502
71123873|NCT05160766|141753598|OTHER||Difference of means in percent|3.438|STANDARD_ERROR_OF_MEAN|3.938||0.38344|TWO_SIDED|95.0|-4.318|11.195|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.2+L452M (omicron)."|11.195|-4.318|0.38344
71123874|NCT05160766|141753598|OTHER||Difference of means in percent|3.279|STANDARD_ERROR_OF_MEAN|3.982||0.411|TWO_SIDED|95.0|-4.565|11.124|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.2+L452R (omicron)."|11.124|-4.565|0.41100
71123875|NCT05160766|141753598|OTHER||Difference of means in percent|2.67|STANDARD_ERROR_OF_MEAN|4.014||0.5066|TWO_SIDED|95.0|-5.237|10.577|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.2.12.1 (omicron)."|10.577|-5.237|0.50660
71123876|NCT05160766|141753598|OTHER||Difference of means in percent|4.535|STANDARD_ERROR_OF_MEAN|4.242||0.28604|TWO_SIDED|95.0|-3.82|12.891|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.2.75 (omicron)."|12.891|-3.82|0.28604
71123877|NCT05160766|141753598|OTHER||Difference of means in percent|6.259|STANDARD_ERROR_OF_MEAN|3.98||0.11715|TWO_SIDED|95.0|-1.582|14.1|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.2.75.2 (omicron)."|14.1|-1.582|0.11715
70945060|NCT00943722|141390614|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.6|||||TWO_SIDED|95.0|-0.4|1.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 6||1.7|-0.4|
70945061|NCT00943722|141390614|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 11||0.7|-0.7|
70945062|NCT00943722|141390614|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 11||1.3|-0.4|
70945063|NCT00943722|141390614|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 11||1.3|-0.4|
70945064|NCT00943722|141390614|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 16||0.7|-0.7|
70945065|NCT00943722|141390614|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 16||1.3|-0.4|
70945066|NCT00943722|141390614|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 16||1.3|-0.4|
71086131|NCT02157519|141677913|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.28||0.481|TWO_SIDED|95.0|-0.35|0.75||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing change in treatment satisfaction with nursing care (FACIT-TS-PS Nursing Care) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.75|-0.35|0.481
71086132|NCT02157519|141677913|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.17||0.97|TWO_SIDED|95.0|-0.34|0.35||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing change in treatment satisfaction with trust in clinicians (FACIT-TS-PS Trust in Clinicians) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.35|-0.34|0.970
71123878|NCT05160766|141753598|OTHER||Difference of means in percent|3.818|STANDARD_ERROR_OF_MEAN|3.957||0.33567|TWO_SIDED|95.0|-3.978|11.613|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.3 (omicron)."|11.613|-3.978|0.33567
71123879|NCT05160766|141753598|OTHER||Difference of means in percent|5.775|STANDARD_ERROR_OF_MEAN|4.022||0.15232|TWO_SIDED|95.0|-2.147|13.697|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BF.7 (omicron)."|13.697|-2.147|0.15232
71123880|NCT05160766|141753598|OTHER||Difference of means in percent|4.808|STANDARD_ERROR_OF_MEAN|3.845||0.21234|TWO_SIDED|95.0|-2.766|12.383|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BQ.1 (omicron)."|12.383|-2.766|0.21234
71123881|NCT05160766|141753598|OTHER||Difference of means in percent|4.58|STANDARD_ERROR_OF_MEAN|3.78||0.22687|TWO_SIDED|95.0|-2.866|12.026|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BQ.1.1 (omicron)."|12.026|-2.866|0.22687
71123882|NCT05160766|141753598|OTHER||Difference of means in percent|3.498|STANDARD_ERROR_OF_MEAN|4.047||0.38832|TWO_SIDED|95.0|-4.475|11.47|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant XBB.1 (omicron)."|11.47|-4.475|0.38832
71123883|NCT04692077|141753623|OTHER||Exact CI for Proportions|88.9|||||TWO_SIDED|95.0|51.8|99.7|||||||Exact 95% Confidence Interval for Proportion for Participants who Reported Grade 2 and Above AEs|99.7|51.8|
71123884|NCT04692077|141753624|OTHER||Exact CI for Proportions|11.1|||||TWO_SIDED|95.0|0.3|48.3|||||||Exact 95% Confidence Interval for Proportion for Participants who Discontinued Early due to Intolerability of Injection or Burden of Study Procedures|48.3|0.3|
71123885|NCT04692077|141753625|OTHER||Exact CI for Proportions|66.7|||||TWO_SIDED|95.0|22.3|95.7|||||||Exact 95% confidence interval for proportion for Participants who received at least one injection and preferred injectable PrEP at end of step 2.|95.7|22.3|
71123886|NCT04692077|141753629|OTHER||Exact CI for Proportions|88.9|||||TWO_SIDED|95.0|51.8|99.7|||||||The Exact 95% Confidence Interval for Proportion for Number of Participants with Grade 2 or above AEs during Injection Phase.|99.7|51.8|
71123887|NCT04692077|141753630|OTHER||Exact CI for Proportions|88.9|||||TWO_SIDED|95.0|51.8|99.7|||||||Exact 95% Confidence Interval for Proportion for Participants who Completed All Scheduled Injections among those who received at least one Injection|99.7|51.8|
71123888|NCT04243330|141753634|SUPERIORITY||Mean Difference (Net)|1.01||||0.18|TWO_SIDED|95.0|-0.46|2.48||the p-values are not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||2.48|-0.46|0.18
71123889|NCT04243330|141753635|SUPERIORITY||Mean Difference (Net)|3.58||||0.06|TWO_SIDED|95.0|-0.11|7.28||the p-values are not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||7.28|-0.11|.06
70945067|NCT00943722|141390614|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|-0.2|||||TWO_SIDED|95.0|-1.1|0.5|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 18||0.5|-1.1|
70945068|NCT00943722|141390614|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.2|||||TWO_SIDED|95.0|-0.7|1.1|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 18||1.1|-0.7|
70945069|NCT00943722|141390614|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 18||1.3|-0.4|
70945070|NCT00943722|141390614|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 31||0.7|-0.7|
70945071|NCT00943722|141390614|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.2|||||TWO_SIDED|95.0|-0.6|1.0|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 31||1.0|-0.6|
71086133|NCT02157519|141677914|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.682|TWO_SIDED|95.0|-0.15|0.1||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the number of emergency department (ED) visits over the study period between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.10|-0.15|0.682
71086134|NCT02157519|141677915|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.1||0.64|TWO_SIDED|95.0|-0.24|0.15||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the number of hospitalizations over they study period between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment||0.15|-0.24|0.640
71086135|NCT01656395|141677916|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.685|TWO_SIDED|95.0|-0.084|0.127|||cLDA model|||Difference in least squares (LS) means for average change from Baseline over Week 6 to Week 12 in FEV1: MK-1029 10 mg vs. Placebo. Constrained longitudinal data analysis (cLDA) model includes terms for visit as categorical variable, prior inhaled corticosteroid (ICS) use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.127|-0.084|0.685
71086136|NCT01656395|141677916|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.477|TWO_SIDED|95.0|-0.149|0.07|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in FEV1: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.07|-0.149|0.477
71086137|NCT01656395|141677916|SUPERIORITY||Mean Difference (Final Values)|0.019||||0.733|TWO_SIDED|95.0|-0.092|0.13|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in FEV1: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.13|-0.092|0.733
71086138|NCT01656395|141677916|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.89|TWO_SIDED|95.0|-0.115|0.1|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in FEV1: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.1|-0.115|0.89
71086139|NCT01656395|141677916|SUPERIORITY||Mean Difference (Final Values)|-0.004||||0.935|TWO_SIDED|95.0|-0.109|0.1|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in FEV1: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.1|-0.109|0.935
71086140|NCT01656395|141677919|SUPERIORITY||Mean Difference (Final Values)|-7.2||||0.169|TWO_SIDED|95.0|-17.48|3.08|||ANOVA|||Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: MK- 1029 10 mg vs. Placebo. Analysis of variance (ANOVA) model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||3.08|-17.48|0.169
71086141|NCT01656395|141677919|SUPERIORITY||Mean Difference (Final Values)|-9.092||||0.092|TWO_SIDED|95.0|-19.67|1.485|||ANOVA|||Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: MK- 1029 30 mg vs. Placebo. ANOVA model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||1.485|-19.67|0.092
71123890|NCT04243330|141753636|SUPERIORITY||Median Difference (Net)|1.7||||0.6|TWO_SIDED|95.0|-4.5|7.9||the p-values are not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||7.9|-4.5|0.60
71123891|NCT04243330|141753637|SUPERIORITY||Median Difference (Net)|-4.1||||0.36|TWO_SIDED|95.0|-12.8|4.7||p-values are not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||4.7|-12.8|0.36
71123892|NCT04243330|141753638|SUPERIORITY||Mean Difference (Net)|-4.5||||0.02|TWO_SIDED|95.0|-8.3|-0.67||p-values are not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||-0.67|-8.3|.02
71123893|NCT04243330|141753639|SUPERIORITY||Mean Difference (Net)|-0.56||||0.82|TWO_SIDED|95.0|-5.5|4.4|||Mixed Models Analysis|||||4.4|-5.5|0.82
70945072|NCT00943722|141390614|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.2|||||TWO_SIDED|95.0|-0.5|1.0|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 31||1.0|-0.5|
71086142|NCT01656395|141677919|SUPERIORITY||Mean Difference (Final Values)|-9.469||||0.083|TWO_SIDED|95.0|-20.19|1.25|||ANOVA|||Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: MK- 1029 60 mg vs. Placebo. ANOVA model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||1.25|-20.19|0.083
71086143|NCT01656395|141677919|SUPERIORITY||Mean Difference (Final Values)|-4.666||||0.367|TWO_SIDED|95.0|-14.83|5.501|||ANOVA|||Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: MK- 1029 150 mg vs. Placebo. ANOVA model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||5.501|-14.83|0.367
71123894|NCT02753127|141753640|SUPERIORITY||Hazard Ratio (HR)|0.976||||0.3629|TWO_SIDED|95.0|0.854|1.117||1-sided|Log Rank|Based on stratified log-rank test stratified by actual stratification factors. P-value is nominal p-value without multiplicity adjustment.|"Based on Cox Proportional hazards model stratified by actual stratification factors including Time to progression on 1st line therapy, RAS mutation, and Bev as part of study treatment.~A HR \<1 indicates a lower risk with Arm 1 compared with Arm 2."|General population||1.117|0.854|0.3629
71086144|NCT01656395|141677919|SUPERIORITY||Mean Difference (Final Values)|-5.247||||0.308|TWO_SIDED|95.0|-15.36|4.871|||ANOVA|||Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: Montelukast vs. Placebo. ANOVA model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||4.871|-15.36|0.308
71123895|NCT02753127|141753640|SUPERIORITY||Hazard Ratio (HR)|0.969||||0.3782|TWO_SIDED|95.0|0.797|1.179||1-sided|Log Rank|Based on unstratified log-rank test. P-value is nominal p value without multiplicity adjustment.|Hazard Ratio is for Napabucasin + FOLFIRI ± bev vs FOLFIRI ± bev. Based on unstratified Cox proportional hazards model. A hazard ratio \<1 indicates a lower risk with Napabucasin+ FOLFIRI ± bev compared with FOLFIRI ± bev.|activated signal transducers and activators of transcription 3 (pSTAT3)-positive (pSTAT3(+)) Subpopulation patients||1.179|0.797|0.3782
71123896|NCT02753127|141753641|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.7307|TWO_SIDED|95.0|0.917|1.18||1-sided|Log Rank|"Based on stratified log rank test stratified by actual stratification factors~. P-value is nominal p-value without multiplicity adjustment."|"Based on Cox Proportional hazards model stratified by actual stratification~. A HR \<1 indicates a lower risk with Arm 1 compared with Arm 2."|General population||1.180|0.917|0.7307
71123897|NCT02753127|141753641|SUPERIORITY||Hazard Ratio (HR)|1.064||||0.7434|TWO_SIDED|95.0|0.883|1.283||1-sided|Log Rank|Based on unstratified log-rank test. P-value is nominal p-value without multiplicity adjustment.|Hazard ratio is for Napabucasin + FOLFIRI ± bev vs FOLFIRI ± bev. Based on unstratified Cox Proportional hazards model. A hazard ratio \<1 indicates a lower risk with Napabucasin + FOLFIRI ± bev compared with FOLFIRI ± bev.|activated signal transducers and activators of transcription 3 (pSTAT3)-positive (pSTAT3(+)) Subpopulation patients||1.283|0.883|0.7434
71123898|NCT02753127|141753642|SUPERIORITY||rate difference|0.1||||0.4797|TWO_SIDED|95.0|-4.9|5.2||1-sided|Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel test stratified by actual stratification factors. P-value is nominal p-value without multiplicity adjustment .|Treatment difference and 95% CI is based on Harmonic Means method adjusting stratification factor|General population||5.2|-4.9|0.4797
71123899|NCT02753127|141753642|SUPERIORITY||rate difference|-3.1||||0.783|TWO_SIDED|95.0|-11.0|4.7||1-sided|Z test|Based on one-sided Z test. P-value is nominal p-value without multiplicity adjustment.|Treatment difference and 95% CI is based on normal approximation method.|activated signal transducers and activators of transcription 3 (pSTAT3)-positive (pSTAT3(+)) Subpopulation patients||4.7|-11.0|0.783
71123900|NCT02753127|141753643|SUPERIORITY||rate difference|-0.9||||0.6776|TWO_SIDED|95.0|-4.8|3.0||1-sided|Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel test stratified by actual stratification factors. P-value is nominal p-value without multiplicity adjustment.|Treatment difference and 95% CI is based on Harmonic Means method adjusting stratification factor|General population||3.0|-4.8|0.6776
71123901|NCT02753127|141753643|SUPERIORITY||rate difference|-2.0||||0.7513|TWO_SIDED|95.0|-7.7|3.7||1-sided|Z test|Based on one-sided Z test. P-value is nominal p-value without multiplicity adjustment.|Treatment difference and 95% CI is based on normal approximation method.|activated signal transducers and activators of transcription 3 (pSTAT3)-positive (pSTAT3(+)) Subpopulation patients||3.7|-7.7|0.7513
71123902|NCT03826342|141753647|SUPERIORITY|||||||0.2964|||||||Generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||Baseline to 2-month assessment||||0.2964
71123903|NCT03826342|141753647|SUPERIORITY|||||||0.3404|||||||generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||2-month assessment to 6-month assessment||||0.3404
71123904|NCT03826342|141753648|SUPERIORITY|||||||0.7915|||||||Generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||Baseline to 2-month assessment||||0.7915
71123905|NCT03826342|141753648|SUPERIORITY|||||||0.2131|||||||generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||2-month assessment to 6-month assessment||||0.2131
71123906|NCT03826342|141753649|SUPERIORITY|||||||0.8357|||||||Generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||Baseline to 2-month assessment||||0.8357
71123907|NCT03826342|141753649|SUPERIORITY|||||||0.095|||||||generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||2-month assessment to 6-month assessment||||0.0950
71123908|NCT03826342|141753650|SUPERIORITY|||||||0.7496|||||||generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||||||0.7496
71123909|NCT03826342|141753651|SUPERIORITY|||||||0.4492|||||||generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||||||0.4492
71123910|NCT03826342|141753652|SUPERIORITY|||||||0.0765|||||||t-test, 2 sided|||||||0.0765
71123911|NCT03826342|141753653|SUPERIORITY|||||||0.535|||||||t-test, 2 sided|||||||0.535
71123912|NCT03826342|141753654|SUPERIORITY|||||||0.4302|||||||t-test, 2 sided|||||||0.4302
71123913|NCT03826342|141753655|SUPERIORITY|||||||0.807|||||||generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||||||0.8070
71123914|NCT01694108|141753680|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Mann-Whitney-test comparing the decisional conflict scores of participating mothers vs. declining mothers.||||||<0.001
71123915|NCT01657760|141753683|EQUIVALENCE|80% power to detect difference p\<0.05 two tailed|Mean Difference (Final Values)|0.01|STANDARD_DEVIATION|0.03||0.87|TWO_SIDED|||||ANOVA, uncorrected for MC.|ANOVA|||||||0.87
71123916|NCT01114360|141753789|SUPERIORITY_OR_OTHER|||||||0.075|TWO_SIDED||||||ANOVA|Two-way repeated measures mixed model ANOVA.||The null hypothesis is that there is no interaction between the order of randomization and primary outcomes.||||0.075
71123917|NCT01114360|141753789|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||ANOVA|||||||0.75
71123918|NCT01114360|141753790|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||ANOVA|||||||0.79
71123919|NCT01114360|141753791|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||ANOVA|||||||0.21
71123920|NCT01114360|141753792|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||ANOVA|||||||0.64
71123921|NCT01114360|141753793|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||ANOVA|||||||0.89
71123922|NCT01114360|141753794|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||ANOVA|||||||0.97
70856876|NCT02519855|141200274|NON_INFERIORITY_OR_EQUIVALENCE|A lower bound of the 95% CI on the fold difference (GMT ratio \[Concomitant / Nonconcomitant\] at 4 weeks postvaccination) \>0.67 implied that the difference is statistically significantly noninferior to the prespecified clinically relevant decrease of 1.5-fold. A p-value ≤0.025 also supported the conclusion of noninferiority.|GMT Ratio at 4 weeks postvaccination|1.0|||<|0.001|TWO_SIDED|95.0|0.88|1.14|||Longitudinal regression|GMT ratio, 95% CI and p-value were based on a longitudinal regression model adjusting for prevaccination titers and age.||||1.14|0.88|<0.001
70856877|NCT02519855|141200275|NON_INFERIORITY_OR_EQUIVALENCE|A lower bound of the 95% CI on the fold difference (GMT ratio \[Concomitant / Nonconcomitant\] at 4 weeks postvaccination) \>0.67 implied that the difference is statistically significantly noninferior to the prespecified clinically relevant decrease of 1.5-fold. A p-value ≤0.025 also supported the conclusion of noninferiority.|GMT Ratio at 4 weeks postvaccination|0.99|||<|0.001|TWO_SIDED|95.0|0.87|1.13|||Longitudinal regression|GMT ratio, 95% CI and p-value were based on a longitudinal regression model adjusting for prevaccination titers and age.||||1.13|0.87|<0.001
70856878|NCT02415842|141200426|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H1N1\_AS over H1N1\_NAS) at Day 21. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.12|||||TWO_SIDED|95.0|0.73|1.72|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||1.72|0.73|
70856879|NCT02415842|141200426|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H1N1\_AS over H1N1\_NAS) at Day 42. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.23|||||TWO_SIDED|95.0|0.83|1.81|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||1.81|0.83|
70856880|NCT02415842|141200426|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H1N1\_AS over H1N1\_NAS) at Day 182. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|0.88|||||TWO_SIDED|95.0|0.63|1.24|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||1.24|0.63|
71086145|NCT01656395|141677920|SUPERIORITY||Mean Difference (Final Values)|-0.122||||0.429|TWO_SIDED|95.0|-0.427|0.182|||cLDA model|||Difference in LS means for average change from Baseline to Week 12 in DSS: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.182|-0.427|0.429
70856881|NCT02415842|141200427|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H5N1\_AS over H5N1\_NAS) at Day 21 . Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.66|||||TWO_SIDED|95.0|1.12|2.47|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||2.47|1.12|
70856882|NCT02415842|141200427|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H5N1\_AS over H5N1\_NAS) at Day 42. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|2.16|||||TWO_SIDED|95.0|1.54|3.03|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||3.03|1.54|
70945073|NCT00943722|141390614|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 33||0.7|-0.7|
71086146|NCT01656395|141677920|SUPERIORITY||Mean Difference (Final Values)|0.142||||0.37|TWO_SIDED|95.0|-0.169|0.454|||cLDA model|||Difference in LS means for average change from Baseline to Week 12 in DSS: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.454|-0.169|0.370
71123923|NCT01114360|141753795|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANOVA|||||||0.01
71123924|NCT01114360|141753796|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||ANOVA|||The null hypothesis is that there is no interaction between the order of randomization and primary outcomes.||||0.75
71123925|NCT01114360|141753797|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||Friedman|||||||0.71
71123926|NCT01114360|141753798|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED||||||Friedman|||||||0.38
71123927|NCT01114360|141753799|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Friedman|||||||0.11
71123928|NCT01114360|141753800|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||ANOVA|||||||0.96
71123929|NCT01114360|141753801|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||ANOVA|||||||0.25
71123930|NCT01114360|141753802|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||ANOVA|||||||0.52
71123931|NCT03007745|141753805|SUPERIORITY||Mean Difference (Final Values)|1.96|STANDARD_DEVIATION|3.08|<|0.0001|TWO_SIDED|||||Unadjusted|t-test, 2 sided|||Paired t-test comparing baseline and 3-month measures within group||||<0.0001
71123932|NCT03007745|141753805|SUPERIORITY||Mean Difference (Final Values)|1.73|STANDARD_DEVIATION|3.97|<|0.0001|TWO_SIDED||||||t-test, 2 sided|Unadjusted||Paired t-test comparing baseline and 3-month measures within group||||<0.0001
71123933|NCT03007745|141753805|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.61||0.9171|TWO_SIDED|||||Adjusted mean changes and adjusted differences in mean changes were estimated as site-total-sample-size weighted values controlling for treatment group differences in mean pre-treatment baseline values|ANCOVA|||Adjusted differences in mean changes were estimated as site-total-sample-size weighted values controlling for treatment group differences in mean pre-treatment baseline values. ANCOVA model included main effects for type of study (home versus in-laboratory), site, and the pre-treatment baseline value of the outcome measure.||||0.9171
71123934|NCT03007745|141753805|NON_INFERIORITY|We hypothesized that the lower bound of the non-inferiority analysis of FOSQ-10 would be greater than the a-priori threshold of -1.0.|||||>|0.05||||||"Adjusted group difference in mean change in FOSQ-10 score from baseline to Month 3, controlling for baseline FOSQ and site, was -0.06 ± 061 (SEM) (P = 0.917).~The lower bound of the 95% noninferiority confidence interval was -1.08"|ANCOVA|||||||>0.05
70945074|NCT00943722|141390614|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 33||1.3|-0.4|
71123935|NCT03007745|141753806|SUPERIORITY||Mean Difference (Net)|-3.31|STANDARD_DEVIATION|4.86|<|0.0001|ONE_SIDED|||||Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data) Paired t-test comparing baseline and 3-month measures within group|t-test, 2 sided|||Paired t-test comparing baseline and 3-month measures within group||||<0.0001
71123936|NCT03007745|141753806|SUPERIORITY||Mean Difference (Net)|-3.51|STANDARD_DEVIATION|5.52|<|0.0001|TWO_SIDED|||||Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data) Paired t-test comparing baseline and 3-month measures within group|t-test, 2 sided|||Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data) Paired t-test comparing baseline and 3-month measures within group||||<0.0001
71123937|NCT03007745|141753806|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.85||0.9251|ONE_SIDED||||||ANCOVA|ANCOVA included main effects for group, site, and the pre-treatment baseline value of the outcome measure||Adjusted differences in mean changes were estimated as site-total-sample-size weighted values controlling for treatment group differences in mean pre-treatment baseline values. ANCOVA model included main effects for type of study (home versus in-laboratory), site, and the pre-treatment baseline value of the outcome measure.||||0.9251
71123938|NCT03007745|141753807|SUPERIORITY|Paired t-test comparing change in score (3-month - baseline) within group|Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.33||0.4116|ONE_SIDED||||||t-test, 2 sided|Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data)||Within arm change from baseline to 3 month follow-up||||0.4116
71123939|NCT03007745|141753807|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_DEVIATION|0.39||0.2201|ONE_SIDED||||||t-test, 2 sided|||Paired t-test comparing change in score (3-month - baseline) within group||||0.2201
71123940|NCT03007745|141753807|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.06||0.1732|TWO_SIDED||||||ANCOVA|ANCOVA included main effects for group, site, and the pre-treatment baseline value of the outcome measure||Adjusted differences in mean changes between groups from baseline to month 3 in participants initiated on CPAP (LOCF applied using 1-month data).||||0.1732
71123941|NCT03007745|141753808|SUPERIORITY||Mean Difference (Final Values)|-2.76|STANDARD_DEVIATION|4.73|<|0.0003|ONE_SIDED||||||t-test, 2 sided|Unadjusted||Paired t-test comparing baseline and 3-month measures within group||||<0.0003
71123942|NCT03007745|141753808|SUPERIORITY||Mean Difference (Final Values)|-2.38|STANDARD_DEVIATION|5.2|<|0.0001|TWO_SIDED||||||t-test, 2 sided|Unadjusted||Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data) Paired t-test comparing baseline and 3-month measures within group||||<0.0001
71123943|NCT03007745|141753808|SUPERIORITY||Median Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.9||0.673|TWO_SIDED||||||ANCOVA|ANCOVA included main effects for group, site, and the pre-treatment baseline value of the outcome measure||Adjusted differences in mean changes were estimated as site-total-sample-size weighted values controlling for treatment group differences in mean pre-treatment baseline values. Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data)||||0.6730
71123944|NCT03007745|141753809|SUPERIORITY||Mean Difference (Net)|-5.94|STANDARD_DEVIATION|6.17|<|0.0001|TWO_SIDED|||||Unadjusted|t-test, 2 sided|Paired t-test comparing baseline and 3-month measures within group (LOCF applied using 1-month data)||Paired t-test comparing baseline and 3-month measures within group (LOCF applied using 1-month data)||||<0.0001
71123945|NCT03007745|141753809|SUPERIORITY|Paired t-test comparing baseline and 3-month measures within group (LOCF applied using 1-month data)|Mean Difference (Final Values)|-5.6|STANDARD_DEVIATION|6.96||0.0001|TWO_SIDED|||||Unadjusted|t-test, 2 sided|||Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data)||||0.0001
71123946|NCT03007745|141753809|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|1.11||0.9903|TWO_SIDED|||||ANCOVA included main effects for group, site, and the pre-treatment baseline value of the outcome measure|ANCOVA|Adjusted differences in mean changes estimated as site-total-sample-size weighted values controlling for group differences in mean baseline values||Between group comparison of change in Insomnia Severity Index (ISI) at 3 months (LOCF applied using 1-month data)||||0.9903
71123947|NCT03007745|141753813|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||Between group comparison of Client Satisfaction Questionnaire (CSQ-8) at 3 months (LOCF applied using 1-month data)||||>0.05
71123948|NCT03007745|141753814|NON_INFERIORITY|The a-priori lower bound selected for the non-inferiority analysis of average daily CPAP use over 3 months was -0.75 hours.|Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.37||0.308|TWO_SIDED|||||Group difference (REVAMP - In-person) in mean CPAP daily use over all days adjusted for investigative site.|ANCOVA|The lower bound of the 95% noninferiority confidence interval was -0.22.||||||0.308
71123949|NCT00385723|141753819|SUPERIORITY_OR_OTHER||Difference in change from baseline|-0.11|STANDARD_ERROR_OF_MEAN|0.04||0.03|TWO_SIDED|95.0|-0.19|-0.028||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||1.25 g/d minus placebo|Comparison was made on change from baseline to 4 months||-0.028|-0.19|0.03
71123950|NCT00385723|141753819|SUPERIORITY_OR_OTHER||Difference in change from baseline|-0.13|STANDARD_ERROR_OF_MEAN|0.04||0.004|TWO_SIDED|95.0|-0.22|-0.052||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||2.5 g/d minus placebo|Comparison was made on the change from baseline to 4 months.||-0.052|-0.22|0.004
71123951|NCT00385723|141753820|SUPERIORITY_OR_OTHER||Difference in change from baseline|-0.41|STANDARD_ERROR_OF_MEAN|0.1||0.0003|TWO_SIDED|95.0|-0.62|-0.21||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||1.25 g/d minus placebo|Comparison was made on change from baseline to 4 months.||-0.21|-0.62|0.0003
71123952|NCT00385723|141753820|SUPERIORITY_OR_OTHER||Difference in change from baseline|-0.43|STANDARD_ERROR_OF_MEAN|0.11||0.0002|TWO_SIDED|95.0|-0.64|-0.22||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||2.5 g/d minus placebo|Comparison was made on the change from baseline to 4 months.||-0.22|-0.64|0.0002
71123953|NCT00385723|141753821|SUPERIORITY_OR_OTHER||Difference in change from baseline|-0.23|STANDARD_ERROR_OF_MEAN|0.21||0.8|TWO_SIDED|95.0|-0.64|0.18||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||1.25 g/d minus placebo|Comparison was made on the change from baseline to 4 months.||0.18|-0.64|0.80
70945075|NCT00943722|141390614|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 33||1.3|-0.4|
70945076|NCT00943722|141390614|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|-0.2|||||TWO_SIDED|95.0|-1.1|0.5|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 45||0.5|-1.1|
70945077|NCT00943722|141390614|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.2|||||TWO_SIDED|95.0|-0.7|1.1|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 45||1.1|-0.7|
70945078|NCT00943722|141390614|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 45||1.3|-0.4|
70945079|NCT00943722|141390614|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 52||0.7|-0.7|
71086147|NCT01656395|141677920|SUPERIORITY||Mean Difference (Final Values)|-0.089||||0.579|TWO_SIDED|95.0|-0.402|0.225|||cLDA model|||Difference in LS means for average change from Baseline to Week 12 in DSS: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK- 1029 or Montelukast).||0.225|-0.402|0.579
70945080|NCT00943722|141390614|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.3|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 52||1.3|-0.4|
71086148|NCT01656395|141677920|SUPERIORITY||Mean Difference (Final Values)|0.156||||0.305|TWO_SIDED|95.0|-0.142|0.454|||cLDA model|||Difference in LS means for average change from Baseline to Week 12 in DSS: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.454|-0.142|0.305
71123954|NCT00385723|141753821|SUPERIORITY_OR_OTHER||Difference in change from baseline|-0.2|STANDARD_ERROR_OF_MEAN|0.21||1|TWO_SIDED|95.0|-0.61|0.21||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||2.5 g/d minus placebo|Comparison was made on the change from baseline to 4 months.||0.21|-0.61|1.0
71123955|NCT01533922|141753843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.244|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.191|0.298|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 once daily (QD) minus Placebo|||0.298|0.191|<0.0001
71123956|NCT01533922|141753843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.065|0.172|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg|||0.172|0.065|<0.0001
71123957|NCT01533922|141753843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.061|0.167|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD|||0.167|0.061|<0.0001
71123958|NCT01533922|141753843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.164|0.271|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD|||0.271|0.164|<0.0001
71123959|NCT01533922|141753843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.027||0.0008|TWO_SIDED|95.0|0.038|0.145|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD|||0.145|0.038|0.0008
71123960|NCT01533922|141753843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.027||0.0015|TWO_SIDED|95.0|0.034|0.141|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD|||0.141|0.034|0.0015
71123961|NCT01533922|141753844|SUPERIORITY_OR_OTHER||Ratio|1.209|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|1.132|1.292|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 5/5 QD divided by Placebo QD|||1.292|1.132|<0.0001
71123962|NCT01533922|141753844|SUPERIORITY_OR_OTHER||Ratio|1.002|STANDARD_ERROR_OF_MEAN|0.034||0.9633|TWO_SIDED|95.0|0.937|1.07|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 5/5 QD divided by Olodaterol 5 mcg QD|||1.070|0.937|0.9633
71123963|NCT01533922|141753844|SUPERIORITY_OR_OTHER||Ratio|0.993|STANDARD_ERROR_OF_MEAN|0.033||0.8415|TWO_SIDED|95.0|0.93|1.061|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 5/5 QD divided by Tiotropium 5 mcg QD|||1.061|0.930|0.8415
71123964|NCT01533922|141753844|SUPERIORITY_OR_OTHER||Ratio|1.265|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001|TWO_SIDED|95.0|1.184|1.351|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 2.5/5 QD divided by Placebo QD|||1.351|1.184|<0.0001
71123965|NCT01533922|141753844|SUPERIORITY_OR_OTHER||Ratio|1.047|STANDARD_ERROR_OF_MEAN|0.035||0.1717|TWO_SIDED|95.0|0.98|1.119|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 2.5/5 QD divided by Olodaterol 5 mcg QD|||1.119|0.980|0.1717
71123966|NCT01533922|141753844|SUPERIORITY_OR_OTHER||Ratio|1.039|STANDARD_ERROR_OF_MEAN|0.035||0.261|TWO_SIDED|95.0|0.972|1.11|||Mixed Models Analysis||Ratio calculated asTiotropium + olodaterol 2.5/5 QD divided by Tiotropium 5 mcg QD|||1.110|0.972|0.2610
71123967|NCT01533922|141753845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.001||0.0004|TWO_SIDED|95.0|-0.004|-0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Placebo QD|||-0.001|-0.004|0.0004
71123968|NCT01533922|141753845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.8291|TWO_SIDED|95.0|-0.001|0.002|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg QD|||0.002|-0.001|0.8291
71123969|NCT01533922|141753845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.857|TWO_SIDED|95.0|-0.002|0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD|||0.001|-0.002|0.8570
71123970|NCT01533922|141753845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.001|<|0.0001|TWO_SIDED|95.0|-0.005|-0.002|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD|||-0.002|-0.005|<0.0001
71123971|NCT01533922|141753845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.7294|TWO_SIDED|95.0|-0.002|0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD|||0.001|-0.002|0.7294
71123972|NCT01533922|141753845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.001||0.4567|TWO_SIDED|95.0|-0.002|0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD|||0.001|-0.002|0.4567
71123973|NCT01533922|141753846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.323|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.293|0.352|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Placebo QD|||0.352|0.293|<0.0001
71123974|NCT01533922|141753846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.101|0.16|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg QD|||0.160|0.101|<0.0001
71123975|NCT01533922|141753846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.084|0.143|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD|||0.143|0.084|<0.0001
70945081|NCT00943722|141390614|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 52||1.3|-0.4|
70945082|NCT00943722|141390614|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 58||0.7|-0.7|
70945083|NCT00943722|141390614|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 58||1.3|-0.4|
71086149|NCT01656395|141677920|SUPERIORITY||Mean Difference (Final Values)|-0.136||||0.372|TWO_SIDED|95.0|-0.434|0.163|||cLDA model|||Difference in LS means for average change from Baseline to Week 12 in DSS: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.163|-0.434|0.372
71086150|NCT01656395|141677921|SUPERIORITY||Mean Difference (Final Values)|-0.528||||0.114|TWO_SIDED|95.0|-1.184|0.128|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use(Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.128|-1.184|0.114
70945084|NCT00943722|141390614|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 58||1.3|-0.4|
70945085|NCT01036165|141390622|SUPERIORITY_OR_OTHER||Mean positive response|0.78|||||TWO_SIDED|95.0|0.7|0.86|||||Confidence Interval calculated from normal approximation to the binomial. The primary objective was met if the lower limit of the 95% confidence interval was \>0.50.|||0.86|0.70|
70945086|NCT01387815|141390627|OTHER||||||<|0.001|||||||Chi-squared|||Comparison does not include missing.||||<0.001
71086151|NCT01656395|141677921|SUPERIORITY||Mean Difference (Final Values)|-0.075||||0.827|TWO_SIDED|95.0|-0.75|0.6|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.6|-0.75|0.827
71086152|NCT01656395|141677921|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.75|TWO_SIDED|95.0|-0.789|0.569|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.569|-0.789|0.75
71086153|NCT01656395|141677921|SUPERIORITY||Mean Difference (Final Values)|0.275||||0.403|TWO_SIDED|95.0|-0.371|0.921|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.921|-0.371|0.403
71086154|NCT01656395|141677921|SUPERIORITY||Mean Difference (Final Values)|-0.389||||0.237|TWO_SIDED|95.0|-1.035|0.257|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.257|-1.035|0.237
70945087|NCT01387815|141390628|OTHER||||||<|0.001|||||||Log Rank|||||||<0.001
70856883|NCT02415842|141200427|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H5N1\_AS over H5N1\_NAS) at Day 182. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.95|||||TWO_SIDED|95.0|1.49|2.54|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||2.54|1.49|
70856884|NCT02415842|141200427|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H5N1\_AS over H5N1\_NAS) at Day 385 . Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.63|||||TWO_SIDED|95.0|1.32|2.01|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||2.01|1.32|
70945088|NCT01387815|141390629|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
70945089|NCT01387815|141390630|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
70945090|NCT01387815|141390631|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
70945091|NCT01387815|141390632|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
71123976|NCT01533922|141753846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.286|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.256|0.315|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD|||0.315|0.256|<0.0001
71123977|NCT01533922|141753846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.063|0.123|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD|||0.123|0.063|<0.0001
71123978|NCT01533922|141753846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.047|0.106|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD|||0.106|0.047|<0.0001
71123979|NCT03344640|141753872|SUPERIORITY||Mean Difference (Final Values)|-0.77||||0.875|TWO_SIDED|90.0|-8.84|7.3|||LS mean|LS mean change from baseline in WORC total percentage score||All Patients at day 99||7.30|-8.84|0.875
71123980|NCT03344640|141753873|SUPERIORITY||Difference and 90% CI versus placebo|3.97||||0.19|TWO_SIDED|90.0|-1.03|8.97|||LS mean|LS mean change from baseline in WORC total percentage score||All patientts at day 15||8.97|-1.03|0.190
71123981|NCT03344640|141753873|SUPERIORITY||Difference and 90% CI versus placebo|3.97|||||TWO_SIDED|90.0|-3.39|9.11|||LS Mean|LS mean change from baseline in WORC total percentage score||All patients at day 29||9.11|-3.39|
71123982|NCT03344640|141753873|SUPERIORITY||Difference and 90% CI versus placebo|0.761||||0.761|TWO_SIDED|90.0|-8.81|6.08|||LS Mean|LS mean change from baseline in WORC total percentage score||All patients at day 57||6.08|-8.81|0.761
71123983|NCT03344640|141753873|SUPERIORITY||Difference and 90% CI versus placebo|0.765||||0.765|TWO_SIDED|90.0|-6.27|9.03|||LS Mean|LS mean change from baseline in WORC total percentage score||All patients at day 85||9.03|-6.27|0.765
71123984|NCT03344640|141753873|SUPERIORITY||Difference and 90% CI versus placebo|0.491||||0.491|TWO_SIDED|90.0|-4.73|11.45|||LS Mean|LS mean change from baseline in WORC total percentage score||All patients at day 127||11.45|-4.73|0.491
71123985|NCT03344640|141753873|SUPERIORITY||Difference and 90% CI versus placebo|2.44||||0.639|TWO_SIDED|90.0|-6.19|11.07|||LS Mean|LS mean change from baseline in WORC total percentage score||All patients at end of study||11.07|-6.19|0.639
71123986|NCT03344640|141753874|SUPERIORITY||Difference and 90% CI versus Placebo|1.23||||0.735|TWO_SIDED|90.0|-4.81|7.28||Difference and 90% CI versus placebo|LS Mean|LS mean change from baseline in QuickDASH total score||Statistical analysis results of QuickDASH total score (PD Analysis Set) at day 99||7.28|-4.81|0.735
71123987|NCT03344640|141753874|SUPERIORITY||Difference and 90% CI versus Placebo|1.51||||0.689|TWO_SIDED|90.0|-4.76|7.79|||LS Mean|LS mean change from baseline in QuickDASH total score||Statistical analysis results of QuickDASH total score (PD analysis set) at End of Study||7.79|-4.76|0.689
71123988|NCT03344640|141753875|SUPERIORITY||Difference and 90% CI vesus placebo|3.5||||0.411|TWO_SIDED|90.0|-3.54|10.54|||LS Mean|LS mean change from baseline in ASES total percentage score||Statistical analysis results of ASES total score (PD analysis) at day 99||10.54|-3.54|0.411
70945092|NCT01387815|141390633|OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
70945093|NCT01387815|141390634|OTHER|||||||0.016|||||||t-test, 2 sided|||||||0.016
70945094|NCT01387815|141390635|OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.060
70945095|NCT01387815|141390636|OTHER|||||||0.056|||||||t-test, 2 sided|||||||0.056
70945096|NCT01387815|141390637|OTHER|||||||0.755|||||||t-test, 2 sided|||||||0.755
70945097|NCT01387815|141390638|OTHER|||||||0.091|||||||t-test, 2 sided|||||||0.091
70945098|NCT01387815|141390639|OTHER|||||||0.106|||||||t-test, 2 sided|||||||0.106
70945099|NCT01387815|141390640|OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
70945100|NCT01387815|141390641|OTHER|||||||0.008|||||||t-test, 2 sided|||||||0.008
70945101|NCT01387815|141390642|OTHER|||||||0.083|||||||t-test, 2 sided|||||||0.083
71123989|NCT03344640|141753875|SUPERIORITY||Difference and 90% CI versus placebo|1.14||||0.804|TWO_SIDED|90.0|-6.5|8.78|||LS Mean|LS mean change from baseline in ASES total percentage score||Statistical analysis results of ASES total score (PD analysis) at End of Study set)||8.78|-6.50|0.804
71123990|NCT03344640|141753876|SUPERIORITY||Difference and 90% CI versus placebo|-1.26||||0.706|TWO_SIDED|90.0|-6.81|4.29|||LS Mean|LS Mean change from baseline in Your Health Today Score at day 99||Statistical analysis results of Your Health Today EQ-5D-5L Index score at day 99 (PD Analysis Set)||4.29|-6.81|0.706
71123991|NCT03344640|141753876|SUPERIORITY||Difference and 90% CI versus placebo|-1.9||||0.647|TWO_SIDED|90.0|-8.79|4.99|||LS Mean|LS mean change from baseline in Your Health Today score||Statistical analysis results of Your Health Today EQ-5D-5L Index score at End of Study||4.99|-8.79|0.647
71123992|NCT03344640|141753877|SUPERIORITY||Difference and 90% CI versus placebo|0.01||||0.613|TWO_SIDED|90.0|-0.03|0.06|||LS Mean|LS mean change from baseline in EQ-5D-5L Index score||Statistical analysis results of of EQ-5D-5L Index score at day 99 (PD Analysis Set)||0.06|-0.03|0.613
71123993|NCT03344640|141753877|SUPERIORITY||Difference and 90% CI versus placebo|0.02||||0.74|TWO_SIDED|90.0|-0.04|0.06|||LS Mean|LS mean change from baseline in EQ-5D-5L Index score||Statistical analysis results of of EQ-5D-5L Index score at End of Study (PD Analysis Set)||0.06|-0.04|0.740
71123994|NCT03344640|141753878|SUPERIORITY||Difference and 90% CI versus placebo|-5.55||||0.281|TWO_SIDED|90.0|-14.07|2.97|||LS Mean|LS MMean CFB (90% CI)||Statistical analysis results of pain score using VAS scale (PD Analysis Set) at day 99||2.97|-14.07|0.281
70856885|NCT02415842|141200428|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H9N2\_AS over H9N2\_NAS) at Day 21. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.39|||||TWO_SIDED|95.0|1.14|1.69|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||1.69|1.14|
70856886|NCT02415842|141200428|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H9N2\_AS over H9N2\_NAS) at Day 42. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.49|||||TWO_SIDED|95.0|1.28|1.73|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||1.73|1.28|
70856887|NCT02415842|141200428|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H9N2\_AS over H9N2\_NAS) at Day 182. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.2|||||TWO_SIDED|95.0|1.0|1.44|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||1.44|1.00|
70856888|NCT02415842|141200429|EQUIVALENCE|Difference between groups (H1N1\_AS minus H1N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 21.|Difference in percentage of subjects|10.79|||||TWO_SIDED|95.0|-16.5|36.83|||Asymptotic standardized 95% CI|||||36.83|-16.50|
70945102|NCT01387815|141390643|OTHER|||||||0.495|||||||t-test, 2 sided|||||||0.495
70945103|NCT01387815|141390644|OTHER|||||||0.097|||||||t-test, 2 sided|||||||0.097
70945104|NCT01387815|141390645|OTHER|||||||0.006|||||||t-test, 2 sided|||||||0.006
71086155|NCT01656395|141677922|SUPERIORITY||Mean Difference (Final Values)|-0.241||||0.565|TWO_SIDED|95.0|-1.066|0.583|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.583|-1.066|0.565
71086156|NCT01656395|141677922|SUPERIORITY||Mean Difference (Final Values)|0.135||||0.754|TWO_SIDED|95.0|-0.713|0.983|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.983|-0.713|0.754
71086157|NCT01656395|141677922|SUPERIORITY||cLDA model|-0.251||||0.563|TWO_SIDED|95.0|-1.104|0.603|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.603|-1.104|0.563
71086158|NCT01656395|141677922|SUPERIORITY||Mean Difference (Final Values)|-0.241||||0.559|TWO_SIDED|95.0|-1.053|0.571|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.571|-1.053|0.559
71086159|NCT01656395|141677922|SUPERIORITY||Mean Difference (Final Values)|-0.071||||0.863|TWO_SIDED|95.0|-0.883|0.741|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.741|-0.883|0.863
71086160|NCT01656395|141677923|SUPERIORITY||Mean Difference (Final Values)|0.544||||0.958|TWO_SIDED|95.0|-19.92|21.007|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||21.007|-19.92|0.958
71123995|NCT03344640|141753878|SUPERIORITY||Difference and 90% CI versus placebo|-1.49||||0.78|TWO_SIDED|90.0|-10.33|7.35|||LS Mean|LS Mean CFB (90% CI)||Statistical analysis results of pain score using VAS scale (PD Analysis Set) at End of Study||7.35|-10.33|0.780
71086161|NCT01656395|141677923|SUPERIORITY||Mean Difference (Final Values)|6.251||||0.559|TWO_SIDED|95.0|-14.81|27.307|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: MK- 1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||27.307|-14.81|0.559
71086162|NCT01656395|141677923|SUPERIORITY||Median Difference (Final Values)|9.575||||0.374|TWO_SIDED|95.0|-11.62|30.766|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||30.766|-11.62|0.374
71086163|NCT01656395|141677923|SUPERIORITY||Mean Difference (Final Values)|5.114||||0.618|TWO_SIDED|95.0|-15.04|25.272|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||25.272|-15.04|0.618
71086164|NCT01656395|141677923|SUPERIORITY||Mean Difference (Final Values)|-1.604||||0.876|TWO_SIDED|95.0|-21.76|18.554|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||18.554|-21.76|0.876
71086165|NCT01656395|141677924|SUPERIORITY||Mean Difference (Final Values)|0.076||||0.682|TWO_SIDED|95.0|-0.288|0.44|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.440|-0.288|0.682
70856889|NCT02415842|141200429|EQUIVALENCE|Difference between groups (H1N1\_AS minus H1N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 42.|Difference in percentage of subjects|12.0|||||TWO_SIDED|95.0|-14.45|36.98|||Asymptotic standardized 95% CI|||||36.98|-14.45|
70856890|NCT02415842|141200429|EQUIVALENCE|Difference between groups (H1N1\_AS minus H1N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 182.|Difference in percentage of subjects|-6.07|||||TWO_SIDED|95.0|-30.56|18.65|||Asymptotic standardized 95% CI|||||18.65|-30.56|
70856891|NCT02415842|141200430|EQUIVALENCE|Difference between groups (H5N1\_AS minus H5N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 21.|Difference in percentage of subjects|27.08|||||TWO_SIDED|95.0|5.96|47.01|||Asymptotic standardized 95% CI|||||47.01|5.96|
70945105|NCT01387815|141390646|OTHER|||||||0.037|||||||t-test, 2 sided|||||||0.037
70945106|NCT01387815|141390647|OTHER|||||||0.084|||||||t-test, 2 sided|||||||0.084
70945107|NCT01387815|141390648|OTHER|||||||0.09|||||||t-test, 2 sided|||||||0.090
71123996|NCT03344640|141753879|SUPERIORITY||Difference and 90% CI versus placebo|-3.32||||0.489|TWO_SIDED|90.0|-11.28|4.64|||LS Mean|LS Mean change from baseline in VAS score||Statistical analysis results of pain score using VAS scale (PD Analysis Set) at day 99||4.64|-11.28|0.489
71123997|NCT03344640|141753879|SUPERIORITY||Difference and 90% CI versus placebo|-8.29||||0.087|TWO_SIDED|90.0|-16.26|-0.32|||LS Mean|LS Mean change from baseline in VAS score||Statistical analysis results of pain score using VAS scale at End of Study||-0.32|-16.26|0.087
71123998|NCT03344640|141753880|SUPERIORITY||Difference and 99% CL versus placebo|6.1||||0.21|TWO_SIDED|90.0|-1.9|13.91|||LS Mean|LS Mean CFB (90% CI)||Statistical analysis results of PhGA score using VAS scale at day 99||13.91|-1.90|0.210
71123999|NCT03344640|141753880|SUPERIORITY||Difference and 90% CI versus placebo|-0.37||||0.942|TWO_SIDED|90.0|-8.86|8.11|||LS Mean|LS Mean CFB (90% CI)||Statistical analysis results of PhGA score using VAS scale at End of Study||8.11|-8.86|0.942
71124000|NCT00815191|141753889|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority delta of 0.5°C|Mean Difference (Final Values)|0.091|||<|0.0001|TWO_SIDED|95.0|-0.139|0.321|||ANOVA|Repeated measures ANOVA||||0.321|-0.139|<0.0001
71124001|NCT02576860|141753890|SUPERIORITY|||||||0.799|||||||ANCOVA|||||||0.799
71124002|NCT02576860|141753891|SUPERIORITY|||||||0.858|||||||Cochran-Mantel-Haenszel|||||||0.858
71124003|NCT01355796|141753898|SUPERIORITY||Mean Difference (Net)|1.49|STANDARD_ERROR_OF_MEAN|1.66|<|0.05|TWO_SIDED|95.0|-1.76|4.75|||Mixed Models Analysis|||||4.75|-1.76|<0.05
71124004|NCT00128713|141753917|SUPERIORITY_OR_OTHER|||||||0.83||||||Three one-degree-of-freedom chi-square tests, each comparing a pair of treatment groups. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Fisher Exact|These tests were carried out at the .017 significance level to adjust for the multiple comparisons.||||||0.83
71124005|NCT00128713|141753917|SUPERIORITY_OR_OTHER|||||||0.83||||||Three one-degree-of-freedom chi-square tests, each comparing a pair of treatment groups. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Fisher Exact|These tests were carried out at the .017 significance level to adjust for the multiple comparisons.||||||0.83
71124006|NCT00128713|141753917|SUPERIORITY_OR_OTHER|||||||0.66||||||Three one-degree-of-freedom chi-square tests, each comparing a pair of treatment groups. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Fisher Exact|These tests were carried out at the .017 significance level to adjust for the multiple comparisons.||||||0.66
71124007|NCT00128713|141753918|SUPERIORITY_OR_OTHER|||||||0.02||||||All analyses are based on intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.02
71124008|NCT00128713|141753918|SUPERIORITY_OR_OTHER||||||<|0.001||||||All analyses are based on intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
71124009|NCT00128713|141753918|SUPERIORITY_OR_OTHER||||||<|0.001||||||All analyses are based on intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
71124010|NCT00128713|141753919|SUPERIORITY_OR_OTHER||||||<|0.001||||||All analyses were carried out using intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
71124011|NCT00128713|141753919|SUPERIORITY_OR_OTHER||||||<|0.001||||||All analyses were carried out using intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
70945108|NCT01387815|141390649|OTHER|||||||0.059|||||||t-test, 2 sided|||||||0.059
70945109|NCT01387815|141390650|OTHER|||||||0.004|||||||t-test, 2 sided|||||||0.004
70945110|NCT01387815|141390651|OTHER|||||||0.115|||||||t-test, 2 sided|||||||0.115
70945111|NCT01387815|141390652|OTHER|||||||0.002|||||||Log Rank|||||||0.002
70945112|NCT01387815|141390653|OTHER|||||||0.002|||||||Chi-squared|||"Comparison does not include the Missing category."||||0.002
70945113|NCT01387815|141390654|OTHER|"Comparison does not include the Missing category."||||||0.017|||||||Chi-squared|||||||0.017
71124012|NCT00128713|141753919|SUPERIORITY_OR_OTHER|||||||0.16||||||All analyses were carried out using intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.16
71124013|NCT00128713|141753921|SUPERIORITY_OR_OTHER|||||||0.51||||||Each pair of treatment arms was compared using an exact version of the Mantel-Haenszel test for trend.|Mantel Haenszel|These tests will be carried out at the .017 significance level to adjust for the multiple comparisons||||||0.51
71124014|NCT00128713|141753921|SUPERIORITY_OR_OTHER|||||||0.82||||||Each pair of treatment arms was compared using an exact version of the Mantel-Haenszel test for trend.|Mantel Haenszel|These tests will be carried out at the .017 significance level to adjust for the multiple comparisons||||||0.82
71124015|NCT00128713|141753921|SUPERIORITY_OR_OTHER|||||||0.68||||||Each pair of treatment arms was compared using an exact version of the Mantel-Haenszel test for trend.|Mantel Haenszel|These tests will be carried out at the .017 significance level to adjust for the multiple comparisons||||||0.68
71124016|NCT00424268|141753922|SUPERIORITY_OR_OTHER||Mean Difference (Net)|80.0|STANDARD_ERROR_OF_MEAN|15.0|<|0.0001|TWO_SIDED|95.0|51.0|110.0||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||110|51|<0.0001
71086166|NCT01656395|141677924|SUPERIORITY||Mean Difference (Final Values)|-0.047||||0.807|TWO_SIDED|95.0|-0.422|0.329|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.329|-0.422|0.807
70856892|NCT02415842|141200430|EQUIVALENCE|Difference between groups (H5N1\_AS minus H5N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 42.|Difference in percentage of subjects|36.65|||||TWO_SIDED|95.0|11.41|57.53|||Asymptotic standardized 95% CI|||||57.53|11.41|
70945114|NCT01387815|141390655|OTHER|||||||0.01||||||"Comparison does not include the Missing category."|Chi-squared|||||||0.010
71086167|NCT01656395|141677924|SUPERIORITY||Mean Difference (Final Values)|0.165||||0.403|TWO_SIDED|95.0|-0.222|0.552|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.552|-0.222|0.403
71086168|NCT01656395|141677924|SUPERIORITY||Mean Difference (Final Values)|0.375||||0.051|TWO_SIDED|95.0|-0.001|0.751|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.751|-0.001|0.051
71086169|NCT01656395|141677924|SUPERIORITY||Mean Difference (Final Values)|0.319||||0.086|TWO_SIDED|95.0|-0.045|0.683|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK- 1029 or Montelukast).||0.683|-0.045|0.086
71086170|NCT01656395|141677925|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.7687|TWO_SIDED|95.0|-16.0|21.3|||MN method|||Difference for AQLQ(S) Response Rate: MK-1029 10 mg vs. Placebo. P-values, estimates and 95% confidence intervals (CIs) are based on the Miettinen and Nurminen (MN) method stratified by prior ICS use (Yes/No).||21.3|-16.0|0.7687
71086171|NCT01656395|141677925|SUPERIORITY||Mean Difference (Final Values)|-6.6||||0.4943|TWO_SIDED|95.0|-24.9|12.2|||MN Method|||Difference for AQLQ(S) Response Rate: MK-1029 30 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||12.2|-24.9|0.4943
71086172|NCT01656395|141677925|SUPERIORITY||Mean Difference (Final Values)|10.5||||0.3003|TWO_SIDED|95.0|-9.4|29.6|||MN method|||Difference for AQLQ(S) Response Rate: MK-1029 60 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||29.6|-9.4|0.3003
71086173|NCT01656395|141677925|SUPERIORITY||Mean Difference (Final Values)|17.5||||0.0774|TWO_SIDED|95.0|-1.9|35.7|||MN method|||Difference for AQLQ(S) Response Rate: MK-1029 150 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||35.7|-1.9|0.0774
71086174|NCT01656395|141677925|SUPERIORITY||Mean Difference (Final Values)|18.2||||0.0555|TWO_SIDED|95.0|-0.4|35.5|||MN method|||Difference for AQLQ(S) Response Rate: Montelukast vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||35.5|-0.4|0.0555
70856893|NCT02415842|141200430|EQUIVALENCE|Difference between groups (H5N1\_AS minus H5N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 182.|Difference in percentage of subjects|6.39|||||TWO_SIDED|95.0|-11.91|24.71|||Asymptotic standardized 95% CI|||||24.71|-11.91|
70945115|NCT01387815|141390656|OTHER|||||||0.015|||||||Chi-squared|||"Comparison does not include the Missing category."||||0.015
70945116|NCT01387815|141390657|OTHER|||||||0.06|||||||Chi-squared|||"Comparison does not include the Missing category."||||0.060
70945117|NCT01387815|141390658|OTHER|||||||0.501|||||||t-test, 2 sided|||||||0.501
70945118|NCT01387815|141390659|OTHER|||||||0.807|||||||t-test, 2 sided|||||||0.807
70856894|NCT02415842|141200430|EQUIVALENCE|Difference between groups (H5N1\_AS minus H5N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 365.|Difference in percentage of subjects|6.9|||||TWO_SIDED|95.0|-6.19|22.15|||Asymptotic standardized 95% CI|||||22.15|-6.19|
70856895|NCT02415842|141200431|EQUIVALENCE|Difference between groups (H9N2\_AS minus H9N2\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 21.|Difference in percentage of subjects|3.33|||||TWO_SIDED|95.0|-13.06|20.24|||Asymptotic standardized 95% CI|||||20.24|-13.06|
70856896|NCT02415842|141200431|EQUIVALENCE|Difference between groups (H9N2\_AS minus H9N2\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 42.|Difference in percentage of subjects|16.67|||||TWO_SIDED|95.0|0.35|34.76|||Asymptotic standardized 95% CI|||||34.76|0.35|
70856897|NCT02415842|141200431|EQUIVALENCE|Difference between groups (H9N2\_AS minus H9N2\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 182.|Difference in percentage of subjects|0.24|||||TWO_SIDED|95.0|-13.76|15.0|||Asymptotic standardized 95% CI|||||15.00|-13.76|
71086175|NCT01656395|141677926|SUPERIORITY||Mean Difference (Final Values)|-0.104||||0.603|TWO_SIDED|95.0|-0.495|0.288|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in ACQ Score: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.288|-0.495|0.603
71086176|NCT01656395|141677926|SUPERIORITY||Mean Difference (Final Values)|-0.032||||0.875|TWO_SIDED|95.0|-0.436|0.372|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in ACQ Score: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.372|-0.436|0.875
71086177|NCT01656395|141677926|SUPERIORITY||Mean Difference (Final Values)|-0.151||||0.476|TWO_SIDED|95.0|-0.568|0.265|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in ACQ Score: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.265|-0.568|0.476
71086178|NCT01656395|141677926|SUPERIORITY||Mean Difference (Final Values)|-0.362||||0.079|TWO_SIDED|95.0|-0.767|0.042|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in ACQ Score: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.042|-0.767|0.079
71086179|NCT01656395|141677926|SUPERIORITY||Mean Difference (Final Values)|-0.227||||0.257|TWO_SIDED|95.0|-0.621|0.166|||cLDA model|||"Difference in LS means for change from Baseline to Week 12 in ACQ Score: Montelukast vs. Placebo.~cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast)."||0.166|-0.621|0.257
71086180|NCT01656395|141677927|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.742|TWO_SIDED|95.0|-15.1|21.1|||MN method|||Difference for change from Baseline to Week 12 in ACQ response rate: MK-1029 10 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||21.1|-15.1|0.742
71086181|NCT01656395|141677927|SUPERIORITY||Mean Difference (Final Values)|-3.4||||0.7248|TWO_SIDED|95.0|-22.1|15.4|||MN method|||Difference for change from Baseline to Week 12 in ACQ response rate: MK-1029 30 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||15.4|-22.1|0.7248
71086182|NCT01656395|141677927|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.6991|TWO_SIDED|95.0|-15.6|22.6|||MN method|||Difference for change from Baseline to Week 12 in ACQ response rate: MK-1029 60 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||22.6|-15.6|0.6991
71086183|NCT01656395|141677927|SUPERIORITY||Mean Difference (Final Values)|8.1||||0.3934|TWO_SIDED|95.0|-10.6|26.2|||MN method|||Difference for change from Baseline to Week 12 in ACQ response rate: MK-1029 150 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||26.2|-10.6|0.3934
71086184|NCT01656395|141677927|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.8032|TWO_SIDED|95.0|-16.0|20.5|||MN method|||Difference for change from Baseline to Week 12 in ACQ response rate: Montelukast vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||20.5|-16.0|0.8032
71086185|NCT01656395|141677928|SUPERIORITY||Mean Difference (Final Values)|-0.075||||0.873|TWO_SIDED|95.0|-1.004|0.853|||ANOVA|||Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: MK-1209 10 mg vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK- 1029 or Montelukast).||0.853|-1.004|0.873
71124017|NCT00424268|141753923|SUPERIORITY_OR_OTHER||Mean Difference (Net)|81.0|STANDARD_ERROR_OF_MEAN|15.0|<|0.0001|TWO_SIDED|95.0|51.0|110.0||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||110|51|<0.0001
71086186|NCT01656395|141677928|SUPERIORITY||Mean Difference (Final Values)|-0.376||||0.437|TWO_SIDED|95.0|-1.326|0.575|||ANOVA|||Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: MK-1209 30 mg vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.575|-1.326|0.437
71086187|NCT01656395|141677928|SUPERIORITY||Mean Difference (Final Values)|-0.54||||0.27|TWO_SIDED|95.0|-1.504|0.423|||ANOVA|||Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: MK-1209 60 mg vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.423|-1.504|0.270
71086188|NCT01656395|141677928|SUPERIORITY||Mean Difference (Final Values)|0.079||||0.865|TWO_SIDED|95.0|-0.839|0.997|||ANOVA|||Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: MK-1209 150 mg vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.997|-0.839|0.865
71086189|NCT01656395|141677928|SUPERIORITY||Mean Difference (Final Values)|-0.309||||0.503|TWO_SIDED|95.0|-1.219|0.6|||ANOVA|||Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: Montelukast vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.600|-1.219|0.503
71086190|NCT02256696|141677992|SUPERIORITY||Hazard Ratio (HR)|1.41||||0.1|TWO_SIDED|95.0|0.93|2.12|||Regression, Cox|adjusted for age and sex at birth.||modified intention to treat (mITT) analysis||2.12|0.93|0.10
71086191|NCT02256696|141677992|SUPERIORITY||Hazard Ratio (HR)|1.89||||0.003|TWO_SIDED|95.0|1.24|2.87|||Regression, Cox|adjusted for age and sex at birth.||mITT analysis||2.87|1.24|0.003
71086192|NCT02256696|141677992|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.09|TWO_SIDED|95.0|0.95|2.15|||Regression, Cox|adjusted for age and sex at birth||per protocol||2.15|0.95|0.09
71086193|NCT02256696|141677992|SUPERIORITY||Hazard Ratio (HR)|1.87||||0.005|TWO_SIDED|95.0|1.21|2.89|||Regression, Cox|adjusted for age and sex at birth||per protocol||2.89|1.21|0.005
71086194|NCT02256696|141677995|SUPERIORITY||Hazard Ratio (HR)|1.61||||0.02|TWO_SIDED|95.0|1.07|2.44|||Regression, Cox|adjusted for age and sex at birth.||mITT analysis||2.44|1.07|0.02
71086195|NCT02256696|141677995|SUPERIORITY||Hazard Ratio (HR)|1.8||||0.006|TWO_SIDED|95.0|1.18|2.75|||Regression, Cox|adjusted for age and sex at birth||mITT analysis||2.75|1.18|0.006
71086196|NCT02256696|141677995|SUPERIORITY||Hazard Ratio (HR)|1.6||||0.03|TWO_SIDED|95.0|1.05|2.42|||Regression, Cox|adjusted for age and sex at birth||per protocol analysis||2.42|1.05|0.03
71086197|NCT02256696|141677995|SUPERIORITY||Hazard Ratio (HR)|1.84||||0.007|TWO_SIDED|95.0|1.18|2.85|||Regression, Cox|adjusted for age and sex at birth||per protocol analysis||2.85|1.18|0.007
71086198|NCT01431339|141678014|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority hypothesis test is a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the 95% CI for the difference in response rates in the ITT population is greater than -10% the NI of dalbavancin to vancomycin/linezolid will be concluded.|Difference in Proportions|-1.5||||||95.0|-7.4|4.6|||||Confidence intervals were adjusted for fever at baseline|||4.6|-7.4|
71086199|NCT02227784|141678054|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-33.48|||<|0.001|TWO_SIDED|95.0|-44.4|-23.3|||ANCOVA|||||-23.3|-44.4|<0.001
71086200|NCT02227784|141678054|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-27.24|||<|0.001|TWO_SIDED|95.0|-36.6|-18.5|||ANCOVA|||||-18.5|-36.6|<0.001
71086201|NCT02227784|141678054|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-6.14||||0.045|TWO_SIDED|95.0|-12.2|-0.22|||ANCOVA|||||-0.22|-12.2|0.045
71086202|NCT02227784|141678055|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|125.28|||<|0.001|TWO_SIDED|95.0|117.1|133.6|||Mixed Models Analysis|||||133.6|117.1|<0.001
71086203|NCT02227784|141678055|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|131.48|||<|0.001|TWO_SIDED|95.0|123.5|139.5|||Mixed Models Analysis|||||139.5|123.5|<0.001
71086204|NCT02227784|141678055|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|127.57|||<|0.001|TWO_SIDED|95.0|120.1|135.0|||Mixed Models Analysis|||||135.0|120.1|<0.001
71086205|NCT02227784|141678056|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|46.35|||<|0.001|TWO_SIDED|95.0|40.79|51.98|||ANCOVA|||||51.98|40.79|<0.001
71086206|NCT02227784|141678056|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|52.22|||<|0.001|TWO_SIDED|95.0|47.12|57.33|||ANCOVA|||||57.33|47.12|<0.001
71086207|NCT02227784|141678056|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|48.44|||<|0.001|TWO_SIDED|95.0|43.82|52.86|||ANCOVA|||||52.86|43.82|<0.001
71086208|NCT02227784|141678057|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-26.47|||<|0.001|TWO_SIDED|95.0|-33.4|-20.0|||Mixed Models Analysis|||||-20.0|-33.4|<0.001
71086209|NCT02227784|141678057|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-22.02|||<|0.001|TWO_SIDED|95.0|-28.4|-15.9|||Mixed Models Analysis|||||-15.9|-28.4|<0.001
71086210|NCT02227784|141678057|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-7.05|||<|0.001|TWO_SIDED|95.0|-11.5|-2.68|||Mixed Models Analysis|||||-2.68|-11.5|<0.001
70856898|NCT02057042|141200457|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71086211|NCT02227784|141678058|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-23.16|||<|0.001|TWO_SIDED|95.0|-30.0|-16.5|||ANCOVA|||||-16.5|-30.00|<0.001
71086212|NCT02227784|141678058|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-16.42|||<|0.001|TWO_SIDED|95.0|-22.3|-10.6|||ANCOVA|||||-10.6|-22.3|<0.001
71086213|NCT02227784|141678058|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-4.11||||0.062|TWO_SIDED|95.0|-8.47|0.15|||ANCOVA|||||0.15|-8.47|0.062
71086214|NCT02227784|141678059|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|38.05|||<|0.001|TWO_SIDED|95.0|30.17|45.88|||ANCOVA|||||45.88|30.17|<0.001
71086215|NCT02227784|141678059|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|42.12|||<|0.001|TWO_SIDED|95.0|34.29|49.76|||ANCOVA|||||49.76|34.29|<0.001
71086216|NCT02227784|141678059|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|39.64|||<|0.001|TWO_SIDED|95.0|33.2|46.08|||ANCOVA|||||46.08|33.20|<0.001
71086217|NCT02227784|141678060|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-33.18|||<|0.001|TWO_SIDED|95.0|-44.9|-22.3|||ANCOVA|||||-22.3|-44.9|<0.001
71086218|NCT02227784|141678060|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-32.63|||<|0.001|TWO_SIDED|95.0|-44.0|-21.8|||ANCOVA|||||-21.8|-44.0|<0.001
71086219|NCT02227784|141678060|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-42.15|||<|0.001|TWO_SIDED|95.0|-50.9|-33.4|||ANCOVA|||||-33.4|-50.9|<0.001
71086220|NCT03834506|141678069|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.1677|TWO_SIDED|95.0|0.78|1.09||One-sided p-value based on log-rank test stratified by prior treatment with a NHA (abiraterone acetate) and type of metastases at baseline.|Log Rank||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with a NHA (abiraterone acetate) and type of metastases at baseline.|||1.09|0.78|0.1677
71086221|NCT03834506|141678070|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0335|TWO_SIDED|95.0|0.71|1.01||One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|Log Rank||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|||1.01|0.71|0.0335
70856899|NCT02057042|141200458|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71086222|NCT03834506|141678071|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0331|TWO_SIDED|95.0|0.74|1.01||One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|Log Rank||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|||1.01|0.74|0.0331
71086223|NCT03834506|141678073|OTHER||Percent Difference|-1.8||||0.6545|TWO_SIDED|95.0|-10.7|7.1||Based on Miettinen \& Nurminen method stratified by prior treatment with a NHA (abiraterone acetate) and type of metastases at baseline.|Miettinen & Nurminen method||Based on Miettinen \& Nurminen method stratified by prior treatment with a NHA (abiraterone acetate) and type of metastases at baseline.|||7.1|-10.7|0.6545
71086224|NCT03834506|141678075|OTHER||Hazard Ratio (HR)|1.05||||0.6178|TWO_SIDED|95.0|0.77|1.43|||Log Rank|One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|||1.43|0.77|0.6178
71086225|NCT03834506|141678076|OTHER||Hazard Ratio (HR)|1.54||||0.9788|TWO_SIDED|95.0|1.01|2.33|||Log Rank|One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|||2.33|1.01|0.9788
70856900|NCT02057042|141200459|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
70856901|NCT02057042|141200460|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
70856902|NCT02057042|141200461|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70856903|NCT02057042|141200462|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70856904|NCT03739242|141200476|SUPERIORITY||Least Square Mean difference|-39.16|||<|0.0001|TWO_SIDED|95.0|-48.57|-29.75|||ANCOVA|||||-29.75|-48.57|<0.0001
70856905|NCT03739242|141200477|SUPERIORITY||Least Square Mean difference|-41.24||||0.0001|TWO_SIDED|95.0|-51.73|-30.74|||ANCOVA|||||-30.74|-51.73|0.0001
70856906|NCT03739242|141200478|SUPERIORITY||Least Square Mean difference|0.09||||0.951|TWO_SIDED|95.0|-2.87|3.05|||ANCOVA|||||3.05|-2.87|0.9510
70945119|NCT01387815|141390660|OTHER|||||||0.479|||||||t-test, 2 sided|||||||0.479
70945120|NCT01387815|141390661|OTHER|||||||0.918|||||||t-test, 2 sided|||||||0.918
71086226|NCT03834506|141678077|OTHER||Hazard Ratio (HR)|0.96||||0.297|TWO_SIDED|95.0|0.82|1.12|||Log Rank|One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|||1.12|0.82|0.2970
71086227|NCT03834506|141678078|OTHER||Hazard Ratio (HR)|0.95||||0.2876|TWO_SIDED|95.0|0.78|1.15|||Log Rank|One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|||1.15|0.78|0.2876
71124018|NCT00424268|141753924|SUPERIORITY_OR_OTHER||Rate ratio|0.768|STANDARD_ERROR_OF_MEAN|0.157||0.1957|TWO_SIDED|95.0|0.515|1.146||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|Poisson regression|||||1.146|0.515|0.1957
71124019|NCT00424268|141753925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0032|TWO_SIDED|95.0|0.1|0.7||This secondary endpoint was analyzed in an exploratory manner.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||0.7|0.1|0.0032
71124020|NCT00424268|141753926|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|0.9||0.0051|TWO_SIDED|95.0|-4.5|-0.8||This secondary endpoint was analyzed in an exploratory manner.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||-0.8|-4.5|0.0051
71124021|NCT05714943|141753941|SUPERIORITY|||||||0.99|||||||Regression, Linear|||||||.99
71124022|NCT05714943|141753942|SUPERIORITY|||||||0|||||||Regression, Linear|||||||.00
71124023|NCT05714943|141753943|SUPERIORITY|||||||0.09|||||||Regression, Linear|||||||.09
71124024|NCT05714943|141753944|SUPERIORITY|||||||0.57|||||||Regression, Linear|||||||.57
70856907|NCT03739242|141200479|SUPERIORITY||Least Square Mean difference|-41.7|||<|0.0001|TWO_SIDED|95.0|-51.58|-31.82|||ANCOVA|||||-31.82|-51.58|<0.0001
70945121|NCT01387815|141390662|OTHER|||||||0.609|||||||t-test, 2 sided|||||||0.609
70856908|NCT03739242|141200480|SUPERIORITY||Least Square Mean difference|-7.0||||0.1924|TWO_SIDED|95.0|-17.59|3.59|||ANCOVA|||||3.59|-17.59|0.1924
70945122|NCT01387815|141390663|OTHER|||||||0.367|||||||t-test, 2 sided|||||||0.367
70945123|NCT01387815|141390664|OTHER|||||||0.521|||||||t-test, 2 sided|||||||0.521
70945124|NCT01387815|141390665|OTHER|||||||0.793|||||||t-test, 2 sided|||||||0.793
70945125|NCT01387815|141390666|OTHER|||||||0.442|||||||t-test, 2 sided|||||||0.442
71124025|NCT05714943|141753945|SUPERIORITY|||||||0.32|||||||Regression, Linear|||||||.32
71124026|NCT05714943|141753946|SUPERIORITY|||||||0|||||||Regression, Linear|||||||.00
71124027|NCT05714943|141753947|SUPERIORITY|||||||0.97|||||||Regression, Linear|||||||.97
71124028|NCT05714943|141753948|SUPERIORITY|||||||0.21|||||||Regression, Linear|||||||.21
70856909|NCT03739242|141200481|SUPERIORITY||Least Square Mean difference|-17.26|||<|0.0001|TWO_SIDED|95.0|-23.54|-10.98|||ANCOVA|||||-10.98|-23.54|<0.0001
70856910|NCT03739242|141200482|SUPERIORITY||Least Square Mean difference|-0.91|||<|0.0001|TWO_SIDED|95.0|-1.19|-0.62|||ANCOVA|||||-0.62|-1.19|<0.0001
70945126|NCT01387815|141390667|OTHER|||||||0.434|||||||t-test, 2 sided|||||||0.434
70945127|NCT01387815|141390668|OTHER|||||||0.752|||||||t-test, 2 sided|||||||0.752
70945128|NCT01387815|141390669|OTHER|||||||0.469|||||||t-test, 2 sided|||||||0.469
70945129|NCT01387815|141390670|OTHER|||||||0.419|||||||t-test, 2 sided|||||||0.419
70945130|NCT01387815|141390671|OTHER|||||||0.695|||||||t-test, 2 sided|||||||0.695
70945131|NCT01387815|141390672|OTHER|||||||0.452|||||||t-test, 2 sided|||||||0.452
70945132|NCT01387815|141390673|OTHER|||||||0.008|||||||t-test, 2 sided|||||||0.008
70945133|NCT01387815|141390674|OTHER|||||||0.181|||||||t-test, 2 sided|||||||0.181
70945134|NCT01387815|141390675|OTHER|||||||0.252|||||||t-test, 2 sided|||||||0.252
71124029|NCT05714943|141753949|SUPERIORITY|||||||0.27|||||||Regression, Linear|||||||.27
71124030|NCT05714943|141753950|SUPERIORITY|||||||0|||||||Regression, Linear|||||||.00
71124031|NCT05714943|141753951|SUPERIORITY|||||||0.86|||||||Regression, Linear|||||||.86
71124032|NCT05714943|141753952|SUPERIORITY|||||||0.61|||||||Regression, Linear|||||||.61
71124033|NCT05714943|141753953|SUPERIORITY|||||||0.02|||||||Regression, Linear|||||||.02
71124034|NCT05714943|141753954|SUPERIORITY|||||||0.08|||||||Regression, Linear|||||||.08
71124035|NCT05714943|141753955|SUPERIORITY|||||||0.08|||||||Regression, Linear|||||||.08
71124036|NCT05714943|141753956|SUPERIORITY|||||||0.06|||||||Regression, Linear|||||||.06
71124037|NCT05714943|141753957|SUPERIORITY|||||||0|||||||Regression, Linear|||||||.00
71124038|NCT05714943|141753958|SUPERIORITY|||||||0.88|||||||Regression, Linear|||||||.88
71124039|NCT05714943|141753959|SUPERIORITY|||||||0.94|||||||Regression, Linear|||||||.94
71124040|NCT05601102|141754012|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.41|||||||t-test, 2 sided|||||||.41
71124041|NCT05601102|141754013|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.01|||||||t-test, 2 sided|||Anxiety subscale analysis||||.01
71124042|NCT05601102|141754013|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.42|||||||t-test, 2 sided|||Depression subscale||||.42
71124043|NCT05601102|141754014|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.04|||||||t-test, 2 sided|||||||.04
71124044|NCT05601102|141754015|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.15|||||||t-test, 2 sided|||||||.15
71124045|NCT05601102|141754016|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.02|||||||t-test, 2 sided|||||||.02
71124046|NCT05601102|141754017|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.22|||||||t-test, 2 sided|||||||.22
71124047|NCT05601102|141754018|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.29|||||||t-test, 2 sided|||||||.29
71124048|NCT05601102|141754019|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||1|||||||t-test, 2 sided|||||||1.00
71124049|NCT05601102|141754020|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.6|||||||t-test, 2 sided|||||||.60
70856911|NCT03739242|141200483|SUPERIORITY||Least Square Mean difference|-0.82|||<|0.0001|TWO_SIDED|95.0|-1.05|-0.59|||ANCOVA|||||-0.59|-1.05|<0.0001
71124050|NCT05601102|141754021|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||1|||||||t-test, 2 sided|||||||1.00
71124051|NCT05601102|141754022|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed|||||<|0.001|||||||t-test, 2 sided|||||||<.001
71124052|NCT04908280|141754026|SUPERIORITY|||||||0.0308|||||||ANOVA|||||||0.0308
71124053|NCT00413010|141754054|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.48||||95.0|-2.16|-0.26|||Mixed Models Analysis|Adjusted for treatment, pooled center baseline, HAM-A total score,time,and treatment-by time|Since an interim analysis was conducted and the sample size was larger than the targeted 173 subjects per group, a critical t-value adjustment was 1.977, yielding an adjusted 95% CI shown above.|Null hypothesis: no difference between Pregabalin (150-600 mg/day) BID and Placebo BID treatment groups. An initial sample size of 173 subjects per double-blind treatment group was calculated to provide at least 90% power to detect an effect size (ie, difference in the true means between 2 treatment groups/standard deviation) of 0.36 for the HAM-A total score change from Baseline using a 2-sided nominal significance level of 4.9%.||-0.26|-2.16|
71124054|NCT00413010|141754055|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.49||||95.0|-2.3|-0.4|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 1||-0.4|-2.3|
71124055|NCT00413010|141754055|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.59||||95.0|-2.2|0.1|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 2||0.1|-2.2|
71124056|NCT00413010|141754055|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|0.62||||95.0|-2.7|-0.2|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 3||-0.2|-2.7|
71124057|NCT00413010|141754055|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.64||||95.0|-2.6|-0.1|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 4||-0.1|-2.6|
71124058|NCT00413010|141754055|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.68||||95.0|-2.1|0.5|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 5||0.5|-2.1|
71124059|NCT00413010|141754055|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.22|STANDARD_ERROR_OF_MEAN|0.67||||95.0|-2.5|0.1|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 6||0.1|-2.5|
71124060|NCT00413010|141754055|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|0.77||||95.0|-2.9|0.2|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 8||0.2|-2.9|
71124061|NCT00413010|141754056|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.35||||||95.0|1.37|8.24||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responders at each week with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 1||8.24|1.37|
71124062|NCT00413010|141754056|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.61||||||95.0|0.9|2.87||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responsers at each each with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 2||2.87|0.90|
71124063|NCT00413010|141754056|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.15||||||95.0|1.76|5.66||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responsers at each each with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 3||5.66|1.76|
70945135|NCT01387815|141390679|OTHER|||||||0.143|||||||Chi-squared|||||||0.143
70945136|NCT01387815|141390680|OTHER|||||||0.415|||||||Chi-squared|||||||0.415
71086228|NCT04577794|141678081|SUPERIORITY||Least square (LS) mean difference|0.0|STANDARD_ERROR_OF_MEAN|1.02||0.981|TWO_SIDED|90.0|-1.7|1.7|||ANCOVA|||An analysis of covariance (ANCOVA) was used with a multiple imputation method to handle missing values, with treatment as fixed effect and baseline score as covariate.||1.7|-1.7|0.981
71086229|NCT03311945|141678104|OTHER||||||||||||||||||This was a single-arm study without a comparator group; therefore, no formal hypothesis testing was conducted. The primary endpoint-therapeutic failure at 48 weeks-was analyzed descriptively. The proportion of participants experiencing therapeutic failure was calculated for both the intention-to-treat (ITT) and on-treatment (OT) populations. Exact binomial (Clopper-Pearson) 95% confidence intervals were used to estimate the failure rates.|||
71124064|NCT00413010|141754056|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.8||||||95.0|1.06|3.05||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responsers at each each with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 4||3.05|1.06|
71124065|NCT00413010|141754056|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.57||||||95.0|0.9|2.73||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responsers at each each with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 5||2.73|0.90|
71124066|NCT00413010|141754056|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.52||||||95.0|0.86|2.66||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responsers at each each with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 6||2.66|0.86|
71124067|NCT00413010|141754056|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.86||||||95.0|1.08|3.22||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responsers at each each with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 8||3.22|1.08|
71124068|NCT00413010|141754056|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.77||||||95.0|1.12|2.79||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responders at Week 8 (LOCF) with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 8 (last observation carried forward, LOCF)||2.79|1.12|
71124069|NCT00413010|141754057|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.88||||||95.0|0.94|8.8||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 1||8.80|0.94|
71124070|NCT00413010|141754057|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.49||||||95.0|0.72|3.06||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 2||3.06|0.72|
71124071|NCT00413010|141754057|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.08||||||95.0|1.09|3.97||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 3||3.97|1.09|
71124072|NCT00413010|141754057|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.8||||||95.0|0.99|3.28||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 4||3.28|0.99|
70945137|NCT01387815|141390681|OTHER|||||||0.604|||||||Chi-squared|||||||0.604
70945138|NCT01387815|141390682|OTHER|||||||0.504|||||||Fisher Exact|||||||0.504
70945139|NCT01387815|141390683|OTHER|||||||0.92|||||||Chi-squared|||||||0.920
70945140|NCT01387815|141390684|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
70945141|NCT01387815|141390685|OTHER|||||||0.575|||||||Chi-squared|||||||0.575
70945142|NCT01387815|141390688|OTHER|||||||0.856|||||||Chi-squared|||||||0.856
70945143|NCT01387815|141390689|OTHER|||||||0.623|||||||Chi-squared|||||||0.623
70945144|NCT01387815|141390690|OTHER|||||||0.732|||||||Chi-squared|||||||0.732
70945145|NCT01387815|141390691|OTHER|||||||0.896|||||||t-test, 2 sided|||||||0.896
70945146|NCT01387815|141390692|OTHER|||||||0.879|||||||t-test, 2 sided|||||||0.879
70945147|NCT01387815|141390693|OTHER|||||||0.763|||||||t-test, 2 sided|||||||0.763
70856912|NCT03739242|141200484|SUPERIORITY||Least Square Mean difference|-3.47||||0.4535|TWO_SIDED|95.0|-12.64|5.7|||ANCOVA|||||5.7|-12.64|0.4535
71086230|NCT01107925|141678124|NON_INFERIORITY_OR_EQUIVALENCE|Difference in median MPA in response to 20 μM ADP in LBW participants who received 5 mg prasugrel to the 75th percentile of MPA response to 20 μM ADP in HBW participants who received10 mg prasugrel at the end of Study Period 1 (Baseline through Day 12) was estimated from the observed data.|Estimate of the difference|-10.1||||0.526|TWO_SIDED|95.0|-23.4|0.2|||bootstrap (to determine 95% CI)||Estimate of the difference = \[median (low body weight) - Q3 (higher body weight)\]|||0.20|-23.40|0.526
71086231|NCT03839394|141678147|OTHER|||||||0.012|||||||t-test, 2 sided|||This was a pilot study positioned to determine the effect size of a clinic-based intervention that has not been evaluated previously. Therefore, sample size was determined to be adequate to discern an effect size, but not powered to determine definitive statistical significance.||||0.012
71086232|NCT03839394|141678148|OTHER|||||||0.05|||||||Z-test of Proportions|||This was a pilot study positioned to determine the effect size of a clinic-based intervention that has not been evaluated previously. Therefore, sample size was determined to be adequate to discern an effect size, but not powered to determine definitive statistical significance.||||0.05
71086233|NCT03839394|141678149|OTHER|||||||0.75|||||||t-test, 2 sided|||This was a pilot study positioned to determine the effect size of a clinic-based intervention that has not been evaluated previously. Therefore, sample size was determined to be adequate to discern an effect size, but not powered to determine definitive statistical significance.||||0.750
71124073|NCT00413010|141754057|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.53||||||95.0|0.82|2.85||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 5||2.85|0.82|
70856913|NCT03739242|141200485|SUPERIORITY||Least Square Mean difference|0.74||||0.5594|TWO_SIDED|95.0|-1.76|3.24|||ANCOVA|||||3.24|-1.76|0.5594
70856914|NCT03739242|141200486|SUPERIORITY||Least Square Mean difference|-0.07||||0.9266|TWO_SIDED|95.0|-1.63|1.48|||ANCOVA|||||1.48|-1.63|0.9266
70856915|NCT03739242|141200487|SUPERIORITY||Least Square Mean difference|6.02||||0.2654|TWO_SIDED|95.0|-4.66|16.69|||ANCOVA|||||16.69|-4.66|0.2654
70856916|NCT03739242|141200488|SUPERIORITY||Least Square Mean difference|-5.95||||0.2595|TWO_SIDED|95.0|-16.37|4.47|||ANCOVA|||||4.47|-16.37|0.2595
70856917|NCT03739242|141200489|SUPERIORITY||Least Square Mean difference|0.003||||0.8476|TWO_SIDED|95.0|-0.039|0.032|||ANCOVA|||||0.032|-0.039|0.8476
70945148|NCT01387815|141390694|OTHER|||||||0.657|||||||Chi-squared|||||||0.657
71086234|NCT03839394|141678150|OTHER|||||||0.86|||||||t-test, 2 sided|||This was a pilot study positioned to determine the effect size of a clinic-based intervention that has not been evaluated previously. Therefore, sample size was determined to be adequate to discern an effect size, but not powered to determine definitive statistical significance.||||0.860
71086235|NCT03839394|141678151|OTHER|||||||0.76|||||||t-test, 2 sided|||This was a pilot study positioned to determine the effect size of a clinic-based intervention that has not been evaluated previously. Therefore, sample size was determined to be adequate to discern an effect size, but not powered to determine definitive statistical significance.||||0.760
71086236|NCT00593450|141678178|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \[ETDRS\] visual-acuity chart)|Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|1.7||0.16|TWO_SIDED|99.2|-3.9|2.9||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Avastin Monthly Group - Mean VA Change in Lucentis Monthly Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.||2.9|-3.9|0.16
71086237|NCT00593450|141678178|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \[ETDRS\] visual-acuity chart)|Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|1.6||0.16|TWO_SIDED|99.2|-4.1|2.4||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Avastin as Needed Group - Mean VA Change in Lucentis as Needed Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.||2.4|-4.1|0.16
71086238|NCT00593450|141678178|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \[ETDRS\] visual-acuity chart)|Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|1.5||0.16|TWO_SIDED|99.2|-4.7|1.3||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Lucentis as Needed Group - Mean VA Change in Lucentis Monthly Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.||1.3|-4.7|0.16
70945149|NCT01387815|141390695|OTHER|||||||0.987|||||||Chi-squared|||||||0.987
70945150|NCT01387815|141390696|OTHER|||||||0.011|||||||Fisher Exact|||||||0.011
70945151|NCT01387815|141390697|OTHER|||||||0.351|||||||t-test, 2 sided|||||||0.351
70945152|NCT01387815|141390698|OTHER|||||||0.835|||||||t-test, 2 sided|||||||0.835
70945153|NCT01387815|141390700|OTHER|||||||0.714|||||||Fisher Exact|||||||0.714
70945154|NCT01387815|141390701|OTHER|||||||0.737|||||||Fisher Exact|||||||0.737
70945155|NCT01387815|141390702|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
70945156|NCT01387815|141390706|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
70945157|NCT01387815|141390707|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
70945158|NCT01387815|141390709|OTHER|||||||0.714|||||||Fisher Exact|||||||0.714
70945159|NCT01387815|141390710|OTHER|||||||0.747|||||||Fisher Exact|||||||0.747
70945160|NCT01387815|141390711|OTHER|||||||0.495|||||||Fisher Exact|||||||0.495
70945161|NCT01387815|141390715|OTHER|||||||0.364|||||||Fisher Exact|||||||0.364
70945162|NCT01387815|141390716|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
70945163|NCT01387815|141390717|OTHER|||||||0.723|||||||Fisher Exact|||||||0.723
70945164|NCT01387815|141390724|OTHER|||||||0.006|||||||t-test, 2 sided|||||||0.006
70945165|NCT01387815|141390725|OTHER|||||||0.672|||||||t-test, 2 sided|||||||0.672
70945166|NCT01387815|141390726|OTHER|||||||0.482|||||||t-test, 2 sided|||||||0.482
70945167|NCT01387815|141390727|OTHER|||||||0.938|||||||t-test, 2 sided|||||||0.938
70945168|NCT01387815|141390728|OTHER|||||||0.144|||||||t-test, 2 sided|||||||0.144
70945169|NCT01387815|141390729|OTHER|||||||0.36|||||||t-test, 2 sided|||||||0.360
70945170|NCT01387815|141390730|OTHER|||||||0.808|||||||t-test, 2 sided|||||||0.808
70945171|NCT01387815|141390731|OTHER|||||||0.208|||||||t-test, 2 sided|||||||0.208
70945172|NCT01387815|141390732|OTHER|||||||0.184|||||||t-test, 2 sided|||||||0.184
70945173|NCT01387815|141390733|OTHER|||||||0.305|||||||t-test, 2 sided|||||||0.305
70945174|NCT01387815|141390735|OTHER|||||||0.757|||||||t-test, 2 sided|||||||0.757
70945175|NCT01387815|141390736|OTHER|||||||0.321|||||||t-test, 2 sided|||||||0.321
70945176|NCT01387815|141390737|OTHER|||||||0.181|||||||t-test, 2 sided|||||||0.181
70945177|NCT01387815|141390738|OTHER|||||||0.395|||||||t-test, 2 sided|||||||0.395
70945178|NCT01387815|141390740|OTHER|||||||0.739|||||||t-test, 2 sided|||||||0.739
70945179|NCT01387815|141390741|OTHER|||||||0.291|||||||t-test, 2 sided|||||||0.291
70945180|NCT01844726|141390790|SUPERIORITY||Mean Difference (Net)|0.05||||0.1|TWO_SIDED||||||t-test, 2 sided|||Change in BOLD signal activation across task derived learning circuit were compared between GLYX-13 and placebo groups using an independent group t-test.||||.10
71124074|NCT00413010|141754057|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.33||||||95.0|0.71|2.48||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 6||2.48|0.71|
70945181|NCT01844726|141390791|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||||||.57
70945182|NCT00307164|141390797|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64||95.0|||||Stratified Wilcoxon rank-sum test|Treatment groups were compared for change in limb fat using a two-sided stratified Wilcoxon rank-sum test (stratified by ARV used)||||||0.64
70945183|NCT00307164|141390798|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||95.0|||||Log Rank|||||||0.17
70945184|NCT00307164|141390800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.25
70945185|NCT00307164|141390802|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.88
70945186|NCT00307164|141390803|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.60
70945187|NCT00307164|141390804|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.13
70945188|NCT00307164|141390805|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.17
70945189|NCT00307164|141390806|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.034
70945190|NCT00307164|141390807|SUPERIORITY_OR_OTHER_LEGACY|||||||0.76||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.76
70945191|NCT00307164|141390808|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.10
70945192|NCT00307164|141390809|SUPERIORITY_OR_OTHER_LEGACY|||||||0.43||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.43
70945193|NCT00307164|141390810|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.17
70945194|NCT00307164|141390811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.80
70945195|NCT00307164|141390812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.42||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.42
70945196|NCT00241969|141390849|SUPERIORITY|Some data were missing for energy intake (n=3 baseline, n=13 post-treatment), thus the PROC MIXED procedure (SAS) with maximum likelihood estimation was used to analyze this outcome with time as a repeated measure factor.|maximum likelihood estimation|431.0|||<|0.001|TWO_SIDED|95.0|282.0|581.0|||ANCOVA||||All analyses were performed on the full intention-to-treat sample (defined a priori as attending the first treatment session). Some data were missing for energy intake (N = 3 baseline; 13 post treatment), and thus the PROC MIXED procedure (SAS) with maximum likelihood estimation was used to analyze this outcome with time as a repeated measures factor, no group main effect at baseline for energy intake, and sex, baseline Pseudomonas aeruginosa status, and treatment modality as covariates in the statistical model. This model is similar to an analysis of covariance model with baseline energy intake included as an additional covariate, but the PROC MIXED model employs maximum likelihood estimation and consequently allows for data to be missing at random. The test of the time by group interaction within this PROC MIXED model indicated whether the behavioral and nutrition treatment was efficacious relative to our control treatment.|581|282|<0.001
70856918|NCT03739242|141200490|SUPERIORITY||Least Square Mean difference|-0.21||||0.1499|TWO_SIDED|95.0|-0.49|0.08|||ANCOVA|||||0.08|-0.49|0.1499
70856919|NCT03739242|141200491|SUPERIORITY||Least Square Mean difference|1.71||||0.7224|TWO_SIDED|95.0|-7.83|11.25|||ANCOVA|||||11.25|-7.83|0.7224
71124075|NCT00413010|141754057|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||||95.0|0.85|2.83||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 8||2.83|0.85|
71124076|NCT00413010|141754057|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.53||||||95.0|0.92|2.53|||Regression, Logistic|Based on fitting a logistic regression on the HAM-A responders at Week 8 (LOCF) with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 8 Last Observation Carried Foward (LOCF)||2.53|0.92|
71124077|NCT00413010|141754058|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0137||||||P-value corresponds to the 2-sided log-rank test.|Log Rank|2-sided log-rank test||Kaplan Meier product limit estimate for calculating median time in days to onset sustained HAM-A Improvement.||||0.0137
71124078|NCT00413010|141754059|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.54||||||95.0|0.96|2.47||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the CGI-I responders at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 1||2.47|0.96|
71124079|NCT00413010|141754059|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.58||||||95.0|1.01|2.47||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 2||2.47|1.01|
71124080|NCT00413010|141754059|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.75||||||95.0|1.09|2.82||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 3||2.82|1.09|
71124081|NCT00413010|141754059|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.26||||||95.0|0.77|2.05||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 4||2.05|0.77|
71124082|NCT00413010|141754059|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.24||||||95.0|0.72|2.11||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 5||2.11|0.72|
71124083|NCT00413010|141754059|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.45||||||95.0|0.84|2.5|||Regression, Logistic|P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 6||2.50|0.84|
71124084|NCT00413010|141754059|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.06||||||95.0|0.61|1.84||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 8||1.84|0.61|
71124085|NCT00413010|141754059|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||||95.0|0.71|1.76||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 8 (LOCF) Last Observation Carried Forward||1.76|0.71|
71124086|NCT00413010|141754060|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.56||||||95.0|1.07|2.3||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Cumulative Logit Model|Based on fitting a logistic regression model for ordinal response of CGI-S scores at Week 8 (LOCF) with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. The odds of having an increasingly better response for pregabalin relative to the odds of having an increasingly better response for placebo.|Week 8 Last Observation Carried Forward (LOCF)||2.30|1.07|
71124087|NCT00413010|141754061|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||||95.0|-1.5|0.0|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 1||0.0|-1.5|
71124088|NCT00413010|141754061|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||||95.0|-1.5|0.2|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 2||0.2|-1.5|
71124089|NCT00413010|141754061|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||||95.0|-1.6|0.1|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 3||0.1|-1.6|
71086239|NCT00593450|141678178|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \[ETDRS\] visual-acuity chart)|Mean Difference (Net)|-2.1|STANDARD_ERROR_OF_MEAN|1.9||0.16|TWO_SIDED|99.2|-5.7|1.6||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Avastin as Needed Group - Mean VA Change in Avastin Monthly Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.||1.6|-5.7|0.16
71086240|NCT00593450|141678178|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \[ETDRS\] visual-acuity chart)|Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|1.7||0.16|TWO_SIDED|99.2|-4.5|2.1||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Lucentis as Needed Group - Mean VA Change in Avastin Monthly Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.||2.1|-4.5|0.16
71086241|NCT00593450|141678178|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \[ETDRS\] visual-acuity chart)|Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|1.7||0.16|TWO_SIDED|99.2|-5.9|0.8||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Avastin as Needed Group - Mean VA Change in Lucentis Monthly Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.||0.8|-5.9|0.16
71086242|NCT00490919|141678208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.225||0.0104|TWO_SIDED|95.0|-1.02|-0.14|||Mixed Models Analysis|Mixed effects general linear model with repeated measures.|Double-blind analysis (comparison between BTDS and placebo TDS) at week 12 of the double-blind phase.|Missing average pain over the last 24 hours scores after treatment discontinuation were imputed using BOCF for adverse event-related withdrawals and LOCF for withdrawals due to other reasons.||-0.14|-1.02|.0104
71086243|NCT00490919|141678209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.124|STANDARD_ERROR_OF_MEAN|0.0874||0.1586|TWO_SIDED|95.0|-0.296|0.048||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holms methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|ANCOVA||Mean comparison from weeks 2-12 of the double-blind phase.|||0.048|-0.296|.1586
71086244|NCT00490919|141678210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4|STANDARD_ERROR_OF_MEAN|1.605||0.0062|TWO_SIDED|95.0|-7.55|-1.25||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holms methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|Mixed Models Analysis|Mixed effects general linear model with repeated measures.|Treatment comparison over Weeks 4, 8, and 12.|The primary comparison between groups was based on estimates and contrasts for the weeks 4, 8, and 12 mean values.||-1.25|-7.55|.0062
71086245|NCT01001429|141678275|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Regression, Logistic|||||||0.04
71086246|NCT01001429|141678275|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||Regression, Linear|||UMSS scores with subjects propofol vs. Dexmetomidine group||||0.68
71086247|NCT01053741|141678294|OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there is no difference in epithelial surface disruption when comparing the two interventions. Power calculation was based on identifying a median difference in histology grade of 0.83, using a two-sided alpha of 0.05 with 90% power in 10 subjects.||||<0.05
71086248|NCT03143257|141678316|SUPERIORITY||Mean Difference (Net)|38.0|STANDARD_DEVIATION|16.1|<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71086249|NCT03143257|141678316|SUPERIORITY||Mean Difference (Net)|43.5|STANDARD_DEVIATION|20.0|<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71086250|NCT03143257|141678316|SUPERIORITY||Mean Difference (Net)|3.7|STANDARD_DEVIATION|5.0|<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
71086251|NCT03143257|141678319|SUPERIORITY||Overall Benefit Score|-15.0|STANDARD_DEVIATION|18.5|||TWO_SIDED||||||||The overall benefit can be determined by subtracting the aided and unaided scores of Ease of Communication, Reverberation, Background Noise \& Aversiveness. A negative score in overall benefit indicates a positive benefit to the subject.|||||
71086252|NCT00619827|141678320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.97||||0.0003|TWO_SIDED|95.0|-2.99|-0.94|||ANCOVA|||||-0.94|-2.99|0.0003
71086253|NCT00104052|141678321|SUPERIORITY_OR_OTHER||Normal approximation to the binomial|0.654||||||95.0|0.564|0.744||||||||0.744|0.564|
71086254|NCT00917124|141678350|SUPERIORITY_OR_OTHER|||||||0.002|||||||Chi-squared, Corrected|||"Hypothesis: intraoperative monitoring of cerebral oxigenation with INVOS system will improve cognitive outcome of patients undergoing CABG procedure.~Sample size was determined assuming 50% incidence of cognitive impairment after cardiac surgery and possibility of decreasing that incidence to 30% using cerebral oximetry. Based on 0.8 power to detect a significant difference (p=0.05), 90 patients were required for each study group."||||0.002
70945197|NCT00241969|141390850|SUPERIORITY|All analyses were performed on the full intention-to-treat sample (defined a priori as attending the first treatment session). Analyses of WAZ change scores were carried out within the PROC GLM procedure (SAS Institute Inc.) using an analysis of covariance model with sex, Pseudomonas aeruginosa status at baseline, treatment modality, and baseline value of the corresponding outcome variable as covariates.|maximum likelihood|0.09||||0.25|TWO_SIDED|95.0|-0.06|0.24|||ANCOVA||||All analyses were performed on the full intention-to-treat sample (defined a priori as attending the first treatment session). Analyses of WAZ change scores were carried out within the PROC GLM procedure (SAS Institute Inc.) using an analysis of covariance model with sex, Pseudomonas aeruginosa status at baseline, treatment modality, and baseline value of the corresponding outcome variable as covariates. Group main effects on these change scores in the presence of covariates were examined to determine the efficacy of the behavioral and nutrition treatment.|0.24|-0.06|0.25
70945198|NCT00241969|141390851|SUPERIORITY|All analyses were performed on the full intention-to-treat sample (defined a priori as attending the first treatment session). Analyses of HAZ change scores were carried out within the PROC GLM procedure (SAS Institute Inc.) using an analysis of covariance model with sex, Pseudomonas aeruginosa status at baseline, treatment modality, and baseline value of the corresponding outcome variable as covariates.|maximum likelihood|0.14||||0.049|TWO_SIDED|95.0|0.001|0.27|||ANCOVA||||All analyses were performed on the full intention-to-treat sample (defined a priori as attending the first treatment session). Analyses of WAZ and HAZ change scores were carried out within the PROC GLM procedure (SAS Institute Inc.) using an analysis of covariance model with sex, Pseudomonas aeruginosa status at baseline, treatment modality, and baseline value of the corresponding outcome variable as covariates. Group main effects on these change scores in the presence of covariates were examined to determine the efficacy of the behavioral and nutrition treatment.|0.27|0.001|0.049
71124090|NCT00413010|141754061|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3||||||95.0|-2.1|-0.6|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 4||-0.6|-2.1|
71124091|NCT00413010|141754061|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||||95.0|-1.3|0.5|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 5||0.5|-1.3|
71124092|NCT00413010|141754061|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||||95.0|-1.8|0.0|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 6||0.0|-1.8|
71124093|NCT00413010|141754061|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||||95.0|-2.1|0.1|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 8||0.1|-2.1|
71124094|NCT01189292|141754062|SUPERIORITY_OR_OTHER||Risk Difference (RD)|28.0||||0.001|TWO_SIDED|95.0|12.0|42.0|||Chi-squared|||null hypothesis: Incidence of PONV is the same in both treatment arms||42|12|0.001
71124095|NCT01189292|141754063|SUPERIORITY_OR_OTHER||Risk Difference (RD)|24.0||||0.006|TWO_SIDED|95.0|7.0|40.0|||Chi-squared|||per protocol analysis||40|7|0.006
71124096|NCT01189292|141754066|SUPERIORITY_OR_OTHER|||||||0.674|TWO_SIDED||||||Mixed Models Analysis|mixed model over the mean ranks at all time points measured (4, 8, 16, 24, 32, 48 hours)||||||0.674
71124097|NCT01189292|141754067|SUPERIORITY_OR_OTHER|||||||0.835|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.835
71124098|NCT00907296|141754083|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.3598|TWO_SIDED|95.0|0.53|1.26|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.26|0.53|0.3598
71124099|NCT00907296|141754083|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.6544|TWO_SIDED|95.0|0.59|1.39|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.39|0.59|0.6544
71124100|NCT00907296|141754083|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9958|TWO_SIDED|95.0|0.64|1.58|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.58|0.64|0.9958
71124101|NCT00907296|141754083|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.6276|TWO_SIDED|95.0|0.59|1.37|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.37|0.59|0.6276
71124102|NCT00907296|141754083|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8819|TWO_SIDED|95.0|0.63|1.49|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.49|0.63|0.8819
71124103|NCT00907296|141754083|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.7197|TWO_SIDED|95.0|0.6|1.42|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.42|0.60|0.7197
71086255|NCT04428385|141678358|SUPERIORITY||Risk Ratio (RR)|0.85|||||TWO_SIDED|95.0|0.34|2.16||||||||2.16|0.34|
71086256|NCT04428385|141678359|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.47|1.78||||||||1.78|0.47|
71086257|NCT04428385|141678360|SUPERIORITY||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.36|1.62||||||||1.62|0.36|
71086258|NCT04428385|141678361|SUPERIORITY||Risk Ratio (RR)|0.67|||||TWO_SIDED|95.0|0.33|1.33||||||||1.33|0.33|
71086259|NCT04428385|141678362|SUPERIORITY||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.62|1.9||||||||1.90|0.62|
70945199|NCT00953199|141390871|SUPERIORITY_OR_OTHER|||||||0.45||||||.05 was set as level of significance|Chi-squared|||We calculated the sample size to be 570 in each arm, providing 80% power, allocation 1:1, two-sided, alpha 0.05, withdrawal rate of 3% and a reduction in pancreatitis from 8% to 4%. Randomization is performed with permuted blocks of 20. Analysis is based on intention to treat.||||.45
71086260|NCT02219685|141678412|SUPERIORITY_OR_OTHER|||||||0.58||||||This p-value for treatment effect on basal ganglia was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.58
71086261|NCT02219685|141678412|SUPERIORITY_OR_OTHER|||||||0.48||||||This p-value for treatment effect on frontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.48
71086262|NCT02219685|141678412|SUPERIORITY_OR_OTHER|||||||0.96||||||This p-value for treatment effect on dorsolateral prefrontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.96
71086263|NCT02219685|141678413|SUPERIORITY_OR_OTHER|||||||0.54||||||This p-value for treatment effect on basal ganglia was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.54
71086264|NCT02219685|141678413|SUPERIORITY_OR_OTHER|||||||0.57||||||This p-value for treatment effect on frontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.57
71086265|NCT02219685|141678413|SUPERIORITY_OR_OTHER|||||||0.63||||||This p-value for treatment effect on dorsolateral prefrontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.63
71086266|NCT02219685|141678414|SUPERIORITY_OR_OTHER|||||||0.7||||||This p-value for treatment effect on basal ganglia was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.70
71086267|NCT02219685|141678414|SUPERIORITY_OR_OTHER|||||||0.21||||||This p-value for treatment effect on frontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.21
71086268|NCT02219685|141678414|SUPERIORITY_OR_OTHER|||||||0.59||||||This p-value for treatment effect on dorsolateral prefrontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.59
70945200|NCT01355471|141390904|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||GEE: Logit link function|Generalized Estimation Equation (GEE) methods with Logit link function and marginal expectation model.||||||<0.001
71086269|NCT02219685|141678415|SUPERIORITY_OR_OTHER|||||||0.0795||||||The p-value was from ANCOVA model for change from baseline with treatment group and baseline as covariates.|ANCOVA|||||||0.0795
71086270|NCT02219685|141678416|SUPERIORITY_OR_OTHER|||||||0.7007||||||The p-value was from ANCOVA model for change from baseline with treatment group and baseline as covariates.|ANCOVA|||||||0.7007
71086271|NCT02219685|141678417|SUPERIORITY_OR_OTHER|||||||0.2677||||||The p-value was ANCOVA model for change from baseline with treatment group and baseline as covariates.|ANCOVA|||||||0.2677
71086272|NCT02219685|141678418|SUPERIORITY_OR_OTHER|||||||0.987||||||The p-value was from ANCOVA model for change from baseline with treatment group and baseline as covariates.|ANCOVA|||||||0.9870
71086273|NCT02219685|141678419|SUPERIORITY_OR_OTHER|||||||0.3388||||||The p-value was from ANCOVA model for change from baseline with treatment group and baseline as covariates.|ANCOVA|||||||0.3388
71086274|NCT02389959|141678441|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of ESS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-1.11||||0.111|TWO_SIDED|95.0|-2.47|0.26|||Regression, Linear|||Analysis between groups at month 1.||0.26|-2.47|0.111
71086275|NCT02389959|141678441|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of ESS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-1.26||||0.131|TWO_SIDED|95.0|-2.9|0.38|||Regression, Linear|||Analysis between groups at month 2.||0.38|-2.9|0.131
71086276|NCT02389959|141678441|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of ESS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-0.85||||0.332|TWO_SIDED|95.0|-2.57|0.88|||Regression, Linear|||Analysis between groups at month 4.||0.88|-2.57|0.332
71086277|NCT02389959|141678441|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of ESS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-0.48||||0.597|TWO_SIDED|95.0|-2.25|1.3|||Regression, Linear|||Analysis between groups at month 6.||1.3|-2.25|0.597
71086278|NCT02389959|141678442|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of PCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|2.85||||0.191|TWO_SIDED|95.0|-1.44|7.13|||Regression, Linear|||Analysis between groups at month 1.||7.13|-1.44|0.191
70945201|NCT00691678|141390914|SUPERIORITY||Mean Difference (Final Values)|-13.3||||0.004|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis measures whether there is a statistically significant change, at the 5% significance level, between the mean WOMAC score among study participants at baseline and at week 24.||||0.004
70945202|NCT01227928|141390915|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.984|||||TWO_SIDED|95.0|0.595|1.626|||||The Hazard Ratio (HR) is estimated using a Pike estimator. The HR was adjusted for the stratification factor of first-line treatment outcome.|||1.626|0.595|
70945203|NCT01227928|141390916|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.811||||0.5901|TWO_SIDED|95.0|0.376|1.751|||Log Rank||The Hazard Ratio (HR) is estimated using a Pike estimator. The HR was adjusted for the three stratification factors.|||1.751|0.376|0.5901
70945204|NCT01042145|141390930|SUPERIORITY_OR_OTHER|||||||0.34|||||||Fisher Exact|||||||0.34
70945205|NCT01042145|141390931|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.63
70945206|NCT01042145|141390933|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.51
70945207|NCT01042145|141390934|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.24
70945208|NCT01042145|141390935|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
70945209|NCT01494298|141390939|SUPERIORITY_OR_OTHER||||||=|0.002||95.0||||The control group average age was 6 years lower(P=0.001). Results were adjusted via a logistic regression and presented as age-adjusted means and SE. The unadjusted differences had similar results.|t-test, 2 sided|||Hypothesis - There will be differences in ApoB between AA with T2DM and those without. To achieve a power of 80%, 48 subjects in each group were needed to detect 15 mg/dL difference in ApoB levels, assuming a standard deviation of 26 mg/dL if alpha was set at 0.05. Continuous data were compared using a Students t-test and categorical data were compared using test.||||=0.002
70945210|NCT01494298|141390941|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||t-test, 2 sided|||||||0.84
71086279|NCT02389959|141678442|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of PCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|0.29||||0.914|TWO_SIDED|95.0|-5.02|5.61|||Regression, Linear|||Analysis between groups at month 2||5.61|-5.02|0.914
70945211|NCT02930837|141390942|SUPERIORITY||Percentage of patients|63.3|||<|0.0001|TWO_SIDED|95.0|54.42|71.42|||One-sample test||Percentage of patients with Favourable outcome|A null hypothesis of p ≤40% versus the alternative hypothesis of p \>40% was tested using a one sample test at two-sided significance level of 0.05, where p denoted the response rate in Chinese patients who were treated within 3-4.5 h after stroke onset.||71.42|54.42|<0.0001
71086280|NCT02389959|141678442|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of PCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|1.55||||0.592|TWO_SIDED|95.0|-4.17|7.28|||Regression, Linear|||Analysis between groups at month 4.||7.28|-4.17|0.592
71086281|NCT02389959|141678442|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of PCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|3.1||||0.31|TWO_SIDED|95.0|-2.92|9.12|||Regression, Linear|||Analysis between groups at month 6||9.12|-2.92|0.31
70945212|NCT01393613|141390952|SUPERIORITY_OR_OTHER|||||||0.0093|||||||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare the average effect analysis for brexpiprazole 2 mg/day and 4 mg/day and placebo combined treatment groups at Week 6. The primary analysis was performed by fitting a Mixed Model Repeated Measures (MMRM) with an unstructured variance covariance structure. The model included fixed class effect terms for treatment, trial site, visit week, baseline, baseline and visit interaction and an interaction term of treatment by visit week.||||0.0093
70945213|NCT01393613|141390952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.47||||0.0022|TWO_SIDED|95.0|-10.6|-2.35|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-2.35|-10.6|0.0022
70945214|NCT01393613|141390952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.08||||0.1448|TWO_SIDED|95.0|-7.23|1.07|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||1.07|-7.23|0.1448
70945215|NCT01393613|141390952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.37||||0.1588|TWO_SIDED|95.0|-8.06|1.32|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6. MMRM analysis fixed effect of treatment, clinical visit, trial site, treatment visit interaction, Baseline value, and Baseline visit interaction as covariates.||1.32|-8.06|0.1588
70945216|NCT01393613|141390953|SUPERIORITY_OR_OTHER|||||||0.0069|||||||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare the average effect analysis for brexpiprazole 2 mg/day and 4 mg/day and placebo combined treatment groups at Week 6.||||0.0069
70945217|NCT01393613|141390953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.0015|TWO_SIDED|95.0|-0.62|-0.15|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6. The analysis of this key secondary endpoint was conducted if both comparisons of brexpiprazole 4 mg/day vs placebo and brexpiprazole 2 mg/day vs placebo of the primary endpoint were significant. Because only the comparison of brexpiprazole 4 mg/day vs placebo met the threshold in the primary analysis, the following analysis is not part of the formal statistical testing and is descriptive only.||-0.15|-0.62|0.0015
70945218|NCT01393613|141390953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.1269|TWO_SIDED|95.0|-0.42|-0.05|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||-0.05|-0.42|0.1269
71124104|NCT00907296|141754083|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.6204|TWO_SIDED|95.0|0.73|1.7|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.70|0.73|0.6204
71124105|NCT00907296|141754083|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.4779|TWO_SIDED|95.0|0.75|1.84|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.84|0.75|0.4779
71124106|NCT00907296|141754083|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9952|TWO_SIDED|95.0|0.65|1.53|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.53|0.65|0.9952
71124107|NCT00907296|141754086|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.1713|TWO_SIDED|95.0|0.47|1.14|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.14|0.47|0.1713
71124108|NCT00907296|141754086|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9958|TWO_SIDED|95.0|0.65|1.53|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.53|0.65|0.9958
71124109|NCT00907296|141754086|SUPERIORITY||Hazard Ratio (HR)|1.27||||0.295|TWO_SIDED|95.0|0.81|1.97|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.97|0.81|0.2950
71124110|NCT00907296|141754086|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0844|TWO_SIDED|95.0|0.44|1.05|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.05|0.44|0.0844
71124111|NCT00907296|141754086|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.3225|TWO_SIDED|95.0|0.52|1.24|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.24|0.52|0.3225
71124112|NCT00907296|141754086|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.4754|TWO_SIDED|95.0|0.76|1.81|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.81|0.76|0.4754
71124113|NCT00907296|141754086|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.5578|TWO_SIDED|95.0|0.74|1.75|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.75|0.74|0.5578
71124114|NCT00907296|141754086|SUPERIORITY||Hazard Ratio (HR)|1.34||||0.1864|TWO_SIDED|95.0|0.87|2.07|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||2.07|0.87|0.1864
71086282|NCT02389959|141678443|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of MCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-2.63||||0.366|TWO_SIDED|95.0|-8.38|3.11|||Regression, Linear|||Analysis between groups at month 1.||3.11|-8.38|0.366
71086283|NCT02389959|141678443|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of MCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|0.82||||0.816|TWO_SIDED|95.0|-6.12|7.76|||Regression, Linear|||Analysis between groups at month 2||7.76|-6.12|0.816
71086284|NCT02389959|141678443|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of MCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-4.3||||0.247|TWO_SIDED|95.0|-11.61|3.02|||Regression, Linear|||Analysis between groups at month 4.||3.02|-11.61|0.247
71124115|NCT00907296|141754086|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.8488|TWO_SIDED|95.0|0.68|1.59|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.59|0.68|0.8488
71124116|NCT00357656|141754092|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority by the 200% margin of non-inferiority was demonstrated if the upper confidence limit of a 95% 2-sided confidence interval for the ratio of means did not exceed 200%.|Mean ratio CI/BI|0.924||||0.001|TWO_SIDED|95.0|0.816|1.046||one-sided p-value against the null hypothesis of ration \>=200%|Hypothesis test|||The main analysis used a point estimate and a two-sided 95% confidence interval for ratio of the primary outcome measure of CI over BI combined over the three strata: stratum A: unilateral knee replacement, stratum B: hip surgery, stratum C: shoulder/elbow/ankle/knee (except knee replacement) surgery.||1.046|0.816|0.001
70856920|NCT02446743|141200492|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[(Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine Group Difference|77.0|||||TWO_SIDED|95.0|68.1|84.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||84.1|68.1|
70856921|NCT02446743|141200492|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|60.0|||||TWO_SIDED|95.0|49.9|69.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||69.2|49.9|
70856922|NCT02446743|141200492|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|68.0|||||TWO_SIDED|95.0|60.5|73.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||73.5|60.5|
70856923|NCT02446743|141200492|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|9.0|||||TWO_SIDED|95.0|5.3|14.8|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||14.8|5.3|
70856924|NCT02446743|141200492|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10 vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|14.0|||||TWO_SIDED|95.0|4.9|24.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||24.2|4.9|
70856925|NCT02446743|141200492|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|10.0|||||TWO_SIDED|95.0|4.3|15.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||15.9|4.3|
70856926|NCT02446743|141200493|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|25.0|||||TWO_SIDED|95.0|18.2|31.4|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||31.4|18.2|
70856927|NCT02446743|141200493|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[(Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine groups difference|22.0|||||TWO_SIDED|95.0|13.2|30.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||30.1|13.2|
70856928|NCT02446743|141200493|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|30.0|||||TWO_SIDED|95.0|20.0|39.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||39.6|20.0|
71086285|NCT02389959|141678443|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of MCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-8.18||||0.035|TWO_SIDED|95.0|-15.76|-0.6|||Regression, Linear|||Analysis between groups at month 6||-0.6|-15.76|0.035
71086286|NCT02389959|141678444|OTHER|||||||0.03|||||||Wilcoxon rank sum test, 2-sided|||Analysis of intergroup difference at baseline.||||0.030
71086287|NCT02389959|141678444|OTHER|||||||0.719|||||||Wilcoxon rank sum test, 2-sided|||Analysis of intergroup difference at month 2.||||0.719
71086288|NCT02389959|141678444|OTHER|||||||0.467|||||||Wilcoxon rank sum test, 2-sided|||Analysis of intergroup difference at month 6.||||0.467
71086289|NCT02634073|141678474|SUPERIORITY_OR_OTHER||Ratio|0.855|||||TWO_SIDED|90.0|0.799|0.914|||ANCOVA||AUC (0-inf) comparison|||0.914|0.799|
71086290|NCT02634073|141678474|SUPERIORITY_OR_OTHER||Ratio|0.677|||||TWO_SIDED|90.0|0.635|0.721|||ANCOVA||AUC (0-inf) comparision|||0.721|0.635|
71086291|NCT02634073|141678474|SUPERIORITY_OR_OTHER||Ratio|0.637|||||TWO_SIDED|90.0|0.594|0.682|||ANCOVA||AUC (0-inf) comparision|||0.682|0.594|
71086292|NCT02634073|141678474|SUPERIORITY_OR_OTHER||Ratio|0.803|||||TWO_SIDED|90.0|0.747|0.864|||ANCOVA||AUC (0-24) comparision|||0.864|0.747|
71086293|NCT02634073|141678474|SUPERIORITY_OR_OTHER||Ratio|0.608|||||TWO_SIDED|90.0|0.566|0.655|||ANOVA||AUC (0-24) comparision|||0.655|0.566|
71086294|NCT02634073|141678474|SUPERIORITY_OR_OTHER||Ratio|0.557|||||TWO_SIDED|90.0|0.518|0.599|||ANCOVA||AUC (0-24) comparision|||0.599|0.518|
71086295|NCT02634073|141678474|SUPERIORITY_OR_OTHER||Ratio|0.819|||||TWO_SIDED|90.0|0.766|0.876|||ANCOVA||AUC (0-t) comparision|||0.876|0.766|
71086296|NCT02634073|141678474|SUPERIORITY_OR_OTHER||Ratio|0.636|||||TWO_SIDED|90.0|0.595|0.68|||ANCOVA||AUC (0-t) comparision|||0.680|0.595|
71086297|NCT02634073|141678474|SUPERIORITY_OR_OTHER||Ratio|0.585|||||TWO_SIDED|90.0|0.548|0.626|||ANCOVA||AUC (0-t) comparision|||0.626|0.548|
71086298|NCT02634073|141678475|SUPERIORITY_OR_OTHER||Ratio|0.993|||||TWO_SIDED|90.0|0.916|1.08|||ANCOVA||C24 comparison|||1.08|0.916|
71086299|NCT02634073|141678475|SUPERIORITY_OR_OTHER||Ratio|1.12|||||TWO_SIDED|90.0|1.03|1.21|||ANCOVA||C24 comparision|||1.21|1.03|
71086300|NCT02634073|141678475|SUPERIORITY_OR_OTHER||Ratio|1.09|||||TWO_SIDED|90.0|1.0|1.18|||ANCOVA||C24 comparision|||1.18|1.000|
71086301|NCT02634073|141678475|SUPERIORITY_OR_OTHER||Ratio|1.33|||||TWO_SIDED|90.0|1.13|1.56|||ANCOVA||Ct comparision|||1.56|1.13|
71086302|NCT02634073|141678475|SUPERIORITY_OR_OTHER||Ratio|1.46|||||TWO_SIDED|90.0|1.25|1.71|||ANCOVA||Ct comparision|||1.71|1.25|
71086303|NCT02634073|141678475|SUPERIORITY_OR_OTHER||Ratio|1.39|||||TWO_SIDED|90.0|1.18|1.63|||ANCOVA||Ct comparision|||1.63|1.18|
71086304|NCT02634073|141678475|SUPERIORITY_OR_OTHER||Ratio|0.724|||||TWO_SIDED|90.0|0.657|0.798|||ANCOVA||Cmax comparision|||0.798|0.657|
71086305|NCT02634073|141678475|SUPERIORITY_OR_OTHER||Ratio|0.479|||||TWO_SIDED|90.0|0.434|0.527|||ANCOVA||Cmax comparision|||0.527|0.434|
71086306|NCT02634073|141678475|SUPERIORITY_OR_OTHER||Ratio|0.454|||||TWO_SIDED|90.0|0.412|0.5|||ANCOVA||Cmax comparision|||0.500|0.412|
71086307|NCT02634073|141678476|SUPERIORITY_OR_OTHER||Ratio|1.37|||||TWO_SIDED|90.0|1.11|1.69|||ANCOVA|||||1.69|1.11|
71086308|NCT02634073|141678476|SUPERIORITY_OR_OTHER||Ratio|1.53|||||TWO_SIDED|90.0|1.25|1.88|||ANCOVA|||||1.88|1.25|
71086309|NCT02634073|141678476|SUPERIORITY_OR_OTHER||Ratio|1.29|||||TWO_SIDED|90.0|1.04|1.61|||ANCOVA|||||1.61|1.04|
71086310|NCT02634073|141678477|SUPERIORITY_OR_OTHER||Ratio|1.17|||||TWO_SIDED|90.0|1.094|1.251|||ANCOVA|||||1.251|1.094|
71086311|NCT02634073|141678477|SUPERIORITY_OR_OTHER||Ratio|1.478|||||TWO_SIDED|90.0|1.386|1.576|||ANCOVA|||||1.576|1.386|
71086312|NCT02634073|141678477|SUPERIORITY_OR_OTHER||Ratio|1.571|||||TWO_SIDED|90.0|1.466|1.684|||ANCOVA|||||1.684|1.466|
71086313|NCT04536701|141678526|SUPERIORITY|||||||0.444|||||||t-test, 2 sided|||Total DASS score reported.||||0.444
71086314|NCT04536701|141678526|SUPERIORITY|||||||0.8378|||||||t-test, 2 sided|||Depressive Mood DASS score reported||||0.8378
71086315|NCT04536701|141678526|SUPERIORITY|||||||0.4087|||||||t-test, 2 sided|||Anxiety DASS score reported||||0.4087
71086316|NCT04536701|141678526|SUPERIORITY|||||||0.4124|||||||t-test, 2 sided|||Stress DASS score reported||||0.4124
71086317|NCT04536701|141678527|SUPERIORITY|||||||0.0508|||||||t-test, 2 sided|||Total RMBPC frequency reported||||0.0508
71086318|NCT04536701|141678527|SUPERIORITY|||||||0.026|||||||t-test, 2 sided|||Frequency of disruptive symptoms on RMBP reported||||0.026
71086319|NCT04536701|141678527|SUPERIORITY|||||||0.1861|||||||t-test, 2 sided|||Frequency of depressive symptoms on RMBPC reported||||0.1861
71086320|NCT04536701|141678527|SUPERIORITY|||||||0.9535|||||||t-test, 2 sided|||Frequency of memory symptoms on RMBPC reported||||0.9535
71086321|NCT04536701|141678527|SUPERIORITY|||||||0.0411|||||||t-test, 2 sided|||RMBPC reaction total is reported||||0.0411
71086322|NCT04536701|141678527|SUPERIORITY|||||||0.0058|||||||t-test, 2 sided|||RMBPC reaction disruptive symptoms is reported||||0.0058
71086323|NCT04536701|141678527|SUPERIORITY|||||||0.2527|||||||t-test, 2 sided|||RMBPC reaction depressive symptoms is reported||||0.2527
71086324|NCT04536701|141678527|SUPERIORITY|||||||0.3542|||||||t-test, 2 sided|||RMBPC reaction memory symptoms||||0.3542
71086325|NCT04536701|141678528|SUPERIORITY|||||||0.3857|||||||t-test, 2 sided|||||||0.3857
71086326|NCT04536701|141678529|SUPERIORITY|||||||0.7213|||||||t-test, 2 sided|||Five Facet Mindfulness Questionnaire (FFMQ) total reported||||0.7213
71086327|NCT04536701|141678529|SUPERIORITY|||||||0.6075|||||||t-test, 2 sided|||FFMQ Observing reported||||0.6075
71086328|NCT04536701|141678529|SUPERIORITY|||||||0.4136|||||||t-test, 2 sided|||FFMQ Describing reported||||0.4136
71086329|NCT04536701|141678529|SUPERIORITY|||||||0.8378|||||||t-test, 2 sided|||FFMQ Acting with Awareness reported||||0.8378
71086330|NCT04536701|141678529|SUPERIORITY|||||||0.7193|||||||t-test, 2 sided|||FFMQ Nonjudging reported||||0.7193
71086331|NCT04536701|141678529|SUPERIORITY|||||||0.4145|||||||t-test, 2 sided|||FFMQ Nonreactivity reported||||0.4145
71086332|NCT04536701|141678530|SUPERIORITY|||||||0.5368|||||||t-test, 2 sided|||||||0.5368
71086333|NCT04536701|141678531|SUPERIORITY|||||||0.2845|||||||t-test, 2 sided|||FAD Total reported||||0.2845
71086334|NCT04536701|141678531|SUPERIORITY|||||||0.1386|||||||t-test, 2 sided|||FAD Problem Solving is reported||||0.1386
71086335|NCT04536701|141678531|SUPERIORITY|||||||0.7551|||||||t-test, 2 sided|||FAD Communication is reported||||0.7551
71086336|NCT04536701|141678531|SUPERIORITY|||||||0.7213|||||||t-test, 2 sided|||FAD Roles is reported||||0.7213
71086337|NCT04536701|141678531|SUPERIORITY|||||||0.3233|||||||t-test, 2 sided|||FAD Affective Responsiveness is reported||||0.3233
71086338|NCT04536701|141678531|SUPERIORITY|||||||0.2832|||||||t-test, 2 sided|||FAD Affective Involvement is reported||||0.2832
71086339|NCT04536701|141678531|SUPERIORITY|||||||0.6831|||||||t-test, 2 sided|||FAD Behavior Control is reported||||0.6831
71086340|NCT04536701|141678531|SUPERIORITY|||||||0.6075|||||||t-test, 2 sided|||FAD General Functioning is reported||||0.6075
71086341|NCT00549549|141678545|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.74|-0.18|||ANCOVA|||This was the primary analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group and region as factors, and the Patient's Assessment of Pain Intensity (for the prior 24 hours) at Baseline as a covariate.||-0.18|-0.74|
71086342|NCT00549549|141678545|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.52|0.04|||ANCOVA|||||0.04|-0.52|
71086343|NCT00549549|141678545|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.29|0.84|||ANCOVA|||||0.84|0.29|
71086344|NCT00549549|141678545|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.05|0.6|||ANCOVA|||||0.60|0.05|
71086345|NCT00549549|141678545|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.17|0.39|||ANCOVA|||||0.39|-0.17|
71086346|NCT00549549|141678546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.29|0.14|||ANCOVA|||Day 5 analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity (for the prior 24 hours) at Baseline as a covariate.||0.14|-0.29|
71086347|NCT00549549|141678546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.42|0.02|||ANCOVA|||Day 5 analysis||0.02|-0.42|
71086348|NCT00549549|141678546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|0.04|0.47|||ANCOVA|||Day 5 analysis||0.47|0.04|
71086349|NCT00549549|141678546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.04|0.39|||ANCOVA|||Day 5 analysis||0.39|-0.04|
71086350|NCT00549549|141678546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.16|0.27|||ANCOVA|||Day 5 analysis||0.27|-0.16|
71086351|NCT00549549|141678546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.26|0.16|||ANCOVA|||Day 9 analysis||0.16|-0.26|
71086352|NCT00549549|141678546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.4|0.03|||ANCOVA|||Day 9 analysis||0.03|-0.40|
71086353|NCT00549549|141678546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.11|0.32|||ANCOVA|||Day 9 analysis||0.32|-0.11|
71086354|NCT00549549|141678546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.16|0.27|||ANCOVA|||Day 9 analysis||0.27|-0.16|
71086355|NCT00549549|141678546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.3|0.13|||ANCOVA|||Day 9 analysis||0.13|-0.30|
71086356|NCT00549549|141678546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.33|0.1|||ANCOVA|||Day 14/early termination analysis||0.10|-0.33|
71086357|NCT00549549|141678546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.53|-0.11|||ANCOVA|||Day 14/early termination analysis||-0.11|-0.53|
71086358|NCT00549549|141678546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.05|0.37|||ANCOVA|||Day /early termination analysis||0.37|-0.05|
71086359|NCT00549549|141678546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.17|0.25|||ANCOVA|||Day 14/early termination analysis||0.25|-0.17|
71086360|NCT00549549|141678546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.38|0.05|||ANCOVA|||Day 14/early termination analysis||0.05|-0.38|
71086361|NCT00549549|141678547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.29|0.22|||ANCOVA|||Day 5 analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity (for the prior 24 hours) at Baseline as a covariate.||0.22|-0.29|
71086362|NCT00549549|141678547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.35|0.16|||ANCOVA|||Day 5 analysis.||0.16|-0.35|
71086363|NCT00549549|141678547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.17|0.34|||ANCOVA|||Day 5 analysis.||0.34|-0.17|
71086364|NCT00549549|141678547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.2|0.3|||ANCOVA|||Day 5 analysis.||0.30|-0.20|
71086365|NCT00549549|141678547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.26|0.25|||ANCOVA|||Day 5 analysis.||0.25|-0.26|
71086366|NCT00549549|141678547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.36|0.11|||ANCOVA|||Day 9 analysis.||0.11|-0.36|
71086367|NCT00549549|141678547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.44|0.04|||ANCOVA|||Day 9 analysis.||0.04|-0.44|
71086368|NCT00549549|141678547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.01|0.46|||ANCOVA|||Day 9 analysis.||0.46|-0.01|
71086369|NCT00549549|141678547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.14|0.33|||ANCOVA|||Day 9 analysis.||0.33|-0.14|
71086370|NCT00549549|141678547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.22|0.26|||ANCOVA|||Day 9 analysis.||0.26|-0.22|
71124117|NCT02573246|141754099|SUPERIORITY|Aimed to recruit 20 participants in each condition to align with other neurostimulation studies where 6-20 adults per condition were sufficient to demonstrate proof-of-concept for novel treatments (Bentwich et al., 2011; Cunningham et al., 2015).|Mean Difference (Net)|-0.323|STANDARD_ERROR_OF_MEAN|0.131||0.019|TWO_SIDED|95.0|-0.59|-0.056||A priori threshold for significance was .05.|Mixed Models Analysis||The results presented are between the active right and sham conditions.|A mixed models analysis of variance (MMANOVA) examining regulation duration during each regulation period was conducted using treatment condition (active right, active left, sham), experimental condition (regulation1, regulation2, regulation3), and baseline as predictors.||-.056|-.590|0.019
71124118|NCT02573246|141754099|SUPERIORITY||Mean Difference (Net)|0.237|STANDARD_ERROR_OF_MEAN|0.133||0.08|TWO_SIDED|95.0|-0.034|0.508|||Mixed Models Analysis|||A mixed models analysis of variance (MMANOVA) examining regulation duration during each regulation period was conducted using treatment condition (active right, active left, sham), experimental condition (regulation1, regulation2, regulation3), and baseline as predictors.||.508|-.034|.08
71124119|NCT02573246|141754099|SUPERIORITY||Mean Difference (Net)|-0.227|STANDARD_ERROR_OF_MEAN|0.103||0.033|TWO_SIDED|95.0|-0.434|-0.02||A priori threshold for significance was set to .05.|Mixed Models Analysis|we controlled for baseline and for the distance between the brain and the scalp||Regulation duration was transformed using a logarithmic transformation to achieve normality||-.020|-.434|.033
71124120|NCT02573246|141754100|SUPERIORITY||Mean Difference (Net)|-0.124|STANDARD_ERROR_OF_MEAN|0.184||0.51|TWO_SIDED|95.0|-0.504|0.256||A priori set threshold for statistical significance was 0.05|ANOVA|||A univariate general linear model was employed to test of regulation duration, transformed for normality.||.256|-0.504|.51
71124121|NCT02573246|141754100|SUPERIORITY||Mean Difference (Net)|0.007|STANDARD_ERROR_OF_MEAN|0.18||0.97|TWO_SIDED|95.0|-0.364|0.378|||ANOVA|||||.378|-.364|.97
71124122|NCT02573246|141754100|SUPERIORITY||Mean Difference (Net)|0.147993|STANDARD_ERROR_OF_MEAN|0.167031||0.39|TWO_SIDED|95.0|-0.215936|0.511921||A priori set significance threshold was 0.05|t-test, 2 sided|||A t test of the variable 'time it took to return to HR baseline', transformed for normality was used to examine between condition differences at the 1 month follow up.||0.511921|-0.215936|0.39
71124123|NCT02573246|141754101|SUPERIORITY|HF-HRV was transformed using the function lg10\*(HF-HRV\*1000000) in order to be normally distributed.|Mean Difference (Net)|0.16|STANDARD_DEVIATION|0.51||0.022|TWO_SIDED|95.0|0.044|0.267||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||In the original study (CR+active left rTMS vs CR+ active right rTMS vs CR+sham rTMS), mixed-effects hierarchical linear models (MMANOVA) with analytically determined covariance structures were used to analyze the repeated measures data. We hypothesized that active neurostimulation would increase HF-HRV during regulation.||.267|.044|.022
71124124|NCT02573246|141754101|SUPERIORITY||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.052||0.0499|TWO_SIDED|95.0|0.000037|0.213074|||Mixed Models Analysis|||MMANOVA||0.213074|0.000037|0.0499
71086371|NCT00549549|141678547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.38|0.1|||ANCOVA|||Day 14/early termination analysis||0.10|-0.38|
71086372|NCT00549549|141678547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.52|-0.04|||ANCOVA|||Day 14/early termination analysis||-0.04|-0.52|
71086373|NCT00549549|141678547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.08|0.39|||ANCOVA|||Day 14/early termination analysis||0.39|-0.08|
71086374|NCT00549549|141678547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.22|0.26|||ANCOVA|||Day 14/early termination analysis||0.26|-0.22|
71086375|NCT00549549|141678547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.36|0.12|||ANCOVA|||Day 14/early termination analysis||0.12|-0.36|
71086376|NCT00549549|141678548|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6402|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.6402
71086377|NCT00549549|141678548|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9739|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.9739
71086378|NCT00549549|141678548|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4581|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.4581
71086379|NCT00549549|141678548|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2962|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.2962
71086380|NCT00549549|141678548|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4951|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.4951
70856929|NCT02446743|141200493|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|4.0|||||TWO_SIDED|95.0|-3.4|11.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||11.9|-3.4|
71086381|NCT00549549|141678548|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4957|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.4957
71086382|NCT00549549|141678548|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8364|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.8364
71086383|NCT00549549|141678548|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6892|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.6892
71086384|NCT00549549|141678548|SUPERIORITY_OR_OTHER_LEGACY|||||||0.411|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.4110
71086385|NCT00549549|141678548|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5981|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.5981
71086386|NCT00549549|141678548|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9317|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.9317
71086387|NCT00549549|141678548|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0831|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.0831
71086388|NCT00549549|141678548|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5747|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.5747
71086389|NCT00549549|141678548|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6204|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.6204
71086390|NCT00549549|141678548|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2556|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analysis||||0.2556
71086391|NCT00549549|141678549|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1444|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.1444
71086392|NCT00549549|141678549|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7532|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.7532
71086393|NCT00549549|141678549|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4722|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.4722
71086394|NCT00549549|141678549|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3878|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.3878
71086395|NCT00549549|141678549|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6717|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.6717
71086396|NCT00549549|141678549|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3098|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.3098
71086397|NCT00549549|141678549|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4356|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.4356
71086398|NCT00549549|141678549|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5703|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.5703
71086399|NCT00549549|141678549|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4986|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.4986
71086400|NCT00549549|141678549|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7855|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.7855
71086401|NCT00549549|141678549|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0169|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.0169
71086402|NCT00549549|141678549|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1353|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.1353
71086403|NCT00549549|141678549|SUPERIORITY_OR_OTHER_LEGACY|||||||0.369|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.3690
71086404|NCT00549549|141678549|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0787|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.0787
71086405|NCT00549549|141678549|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5687|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.5687
71086406|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|||The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular), region and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.||-0.10|-0.60|
71086407|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.75|-0.25|||ANCOVA|||Day 1 analyses||-0.25|-0.75|
71086408|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.29|0.78|||ANCOVA|||Day 1 analyses||0.78|0.29|
71086409|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.06|0.44|||ANCOVA|||Day 1 analyses||0.44|-0.06|
71086410|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.21|0.28|||ANCOVA|||Day 1 analyses||0.28|-0.21|
71086411|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.52|0.04|||ANCOVA|||Day 2 analyses||0.04|-0.52|
71086412|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.74|-0.18|||ANCOVA|||Day 2 analyses||-0.18|-0.74|
71086413|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.29|0.84|||ANCOVA|||Day 2 analyses||0.84|0.29|
71086414|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.05|0.6|||ANCOVA|||Day 2 analyses||0.60|0.05|
71086415|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.17|0.39|||ANCOVA|||Day 2 analyses||0.39|-0.17|
71086416|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.53|0.03|||ANCOVA|||Day 3 analyses||0.03|-0.53|
71086417|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.83|-0.26|||ANCOVA|||Day 3 analyses||-0.26|-0.83|
71086418|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.32|0.88|||ANCOVA|||Day 3 analyses||0.88|0.32|
71086419|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.08|0.64|||ANCOVA|||Day 3 analyses||0.64|0.08|
71124125|NCT02573246|141754101|SUPERIORITY|Aimed to recruit 20 participants in each condition to align with other neurostimulation studies where 6-20 adults per condition were sufficient to demonstrate proof-of-concept for novel treatments (Bentwich et al., 2011; Cunningham et al., 2015).|Mean Difference (Net)|0.172|STANDARD_DEVIATION|0.38|<|1e-06|TWO_SIDED|95.0|0.129|0.215||Significance threshold was set at p = 0.05.|Mixed Models Analysis||The MMANOVA analysis used an unstructured covariance structure.|In the supplemental study (CR+active left rTMS with functional targeting vs CR+sham rTMS), mixed-effects hierarchical linear models (MMANOVA) with analytically determined covariance structures were used to analyze the repeated measures data. We hypothesized that active neurostimulation would increase HF-HRV during regulation when compared with sham.||.215|.129|<.000001
71124126|NCT02573246|141754102|SUPERIORITY||Mean Difference (Net)|0.111|STANDARD_ERROR_OF_MEAN|0.091544||0.236|TWO_SIDED|95.0|-0.078086|0.300661||A priori threshold was set to 0.05.|ANCOVA|Brain to skull difference and intake difference in dlPFC activation between regulation and feeling negative were included as confounds.|Parameter estimate is the value of the difference between active stimulation and sham stimulation.|Difference between treatment conditions in dlPFC activation change between feeling negative emotions and downregulation of negative affect a week after intervention, when controlling for baseline activation difference||0.300661|-0.078086|.236
71124127|NCT02573246|141754102|SUPERIORITY||Mean Difference (Net)|0.359024|STANDARD_ERROR_OF_MEAN|0.144067||0.020347|TWO_SIDED|95.0|0.061|0.657049||Threshold was set at 0.05 a priori|ANCOVA|Brain to skull difference and intake difference in vlpfc activation between regulation and feeling negative were included as confounds.||Expected significantly higher activation following active intervention in the vlPFC when compared to sham when engaging in downregulation versus passive experience of negative emotions induced with autobiographical stressors. ROI data was extracted using FSL featquery. A univariate general linear model excluding one outlier from the active condition was conducted for this outcome measure.||0.657049|0.061000|0.020347
71124128|NCT02573246|141754102|SUPERIORITY||Mean Difference (Net)|0.221683|STANDARD_ERROR_OF_MEAN|0.461481||0.635|TWO_SIDED|95.0|-0.732963|1.17633||A priori threshold was set to .05|ANCOVA|Brain to skull difference and intake difference in vmpfc activation between regulation and feeling negative were included as confounds.||Expected significantly higher activation following active intervention in the vmPFC when compared to sham when engaging in downregulation versus passive experience of negative emotions induced with autobiographical stressors. ROI data was extracted with FSL featquery.||1.176330|-0.732963|0.635
71124129|NCT02573246|141754102|SUPERIORITY||Mean Difference (Net)|0.179412|STANDARD_ERROR_OF_MEAN|0.178029||0.324|TWO_SIDED|95.0|-0.188868|0.547692||a priori set threshold was 0.05|ANCOVA|Brain to skull difference and intake difference in amygdala activation between regulation and feeling negative were included as confounds.||Expected significantly lower activation following active intervention in the amygdala when compared to sham when engaging in downregulation versus passive experience of negative emotions induced with autobiographical stressors. ROI data was extracted with featquery (FSL).||0.547692|-0.188868|.324
70945219|NCT01393613|141390953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.4449|TWO_SIDED|95.0|-0.37|0.16|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.16|-0.37|0.4449
71086420|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.22|0.34|||ANCOVA|||Day 3 analyses||0.34|-0.22|
71124130|NCT02573246|141754102|SUPERIORITY||Mean Difference (Net)|0.021231|STANDARD_ERROR_OF_MEAN|0.071185||0.76819|TWO_SIDED|95.0|-0.126027|0.168489||A priori set threshold was 0.05|ANCOVA|Brain to skull difference and intake difference in insula activation between regulation and feeling negative were included as confounds.||Expected significantly lower activation following active intervention in the insula when compared to sham when engaging in downregulation versus passive experience of negative emotions induced with autobiographical stressors. FSL featquery tool was used to extract ROI (region of interest) data.||0.168489|-0.126027|0.768190
71124131|NCT02573246|141754103|SUPERIORITY||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|0.455||0.69|TWO_SIDED|95.0|-0.553|1.293||a priori threshold for significance was 0.05|ANOVA|||Likert-type questions about acceptability were rated on a scale from 0 (not at all) to 9 (extremely) and then averaged to create a mean for acceptability. This average score was normally distributed and therefore was entered into a univariate general linear model where acceptability was entered as a dependent variable and condition as a fixed factor.||1.293|-0.553|0.69
71124132|NCT02573246|141754103|SUPERIORITY||Mean Difference (Net)|0.27|STANDARD_ERROR_OF_MEAN|0.43||0.53|TWO_SIDED|95.0|-0.592|1.139|||ANOVA|||||1.139|-.592|.53
71124133|NCT02573246|141754103|SUPERIORITY||Mean Difference (Net)|-0.66|STANDARD_ERROR_OF_MEAN|0.45||0.15|TWO_SIDED|95.0|-1.59|0.27||a priory threshold for significance was .05|t-test, 2 sided|||we compared differences in acceptability between conditions using an independent samples t-test (acceptability was normally distributed)||0.27|-1.59|0.15
71124134|NCT02573246|141754104|SUPERIORITY||Mean Difference (Net)|0.295|STANDARD_ERROR_OF_MEAN|0.304||0.551|TWO_SIDED|95.0|-0.322|0.912||a priori threshold was set to 0.05|ANOVA|||We compared differences between conditions in the perceived feasibility of the procedures. Feasibility average was normally distributed and therefore a general linear model, univariate was employed to test between condition effects.||0.912|-0.322|0.551
71124135|NCT02573246|141754104|SUPERIORITY||Mean Difference (Net)|0.002|STANDARD_ERROR_OF_MEAN|0.281||0.995|TWO_SIDED|95.0|-0.567|0.571|||ANOVA|||||.571|-.567|.995
71124136|NCT02573246|141754104|SUPERIORITY||Mean Difference (Net)|-0.09957|STANDARD_ERROR_OF_MEAN|0.371||0.791|TWO_SIDED|95.0|-0.8672|0.6681||A priori threshold for statistical significance was set to 0.05|t-test, 2 sided|df = 23||We examined differences in feasibility between the active and sham condition in the sub-study where fMRI targeting was utilized. Average feasibility was normally distributed and therefore an independent samples t-test was used to test this outcome.||0.6681|-0.8672|0.791
71086421|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.56|0.0|||ANCOVA|||Day 4 analyses||-0.00|-0.56|
71124137|NCT02573246|141754105|SUPERIORITY||Mean Difference (Net)|6.04|STANDARD_ERROR_OF_MEAN|8.048||0.61|TWO_SIDED|95.0|-9.522964|21.60462||A priori threshold was set to 0.05|Mixed Models Analysis|||To test the long-term effects of the intervention, a MMANOVA model was conducted examining between-condition differences at the 1-week and 1-month follow-up in the OQ-45. Baseline was co-varied.||21.604620|-9.522964|0.61
71124138|NCT02573246|141754105|SUPERIORITY||Mean Difference (Net)|-0.906|STANDARD_ERROR_OF_MEAN|7.37||0.9|TWO_SIDED|95.0|-15.83|14.02||a priori threshold was set to .05|Mixed Models Analysis|||||14.02|-15.83|.90
71086422|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.84|-0.28|||ANCOVA|||Day 4 analyses||-0.28|-0.84|
71086423|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.35|0.9|||ANCOVA|||Day 4 analyses||0.90|0.35|
71086424|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.07|0.62|||ANCOVA|||Day 4 analyses||0.62|0.07|
71086425|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.21|0.34|||ANCOVA|||Day 4 analyses||0.34|-0.21|
71086426|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.64|-0.07|||ANCOVA|||Day 5 analyses||-0.07|-0.64|
71086427|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.94|-0.38|||ANCOVA|||Day 5 analyses||-0.38|-0.94|
71086428|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.37|0.93|||ANCOVA|||Day 5 analyses||0.93|0.37|
71086429|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.02|0.57|||ANCOVA|||Day 5 analyses||0.57|0.02|
71086430|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.29|0.27|||ANCOVA|||Day 5 analyses||0.27|-0.29|
71086431|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.65|-0.1|||ANCOVA|||Day 6 analyses||-0.10|-0.65|
71086432|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.84|-0.29|||ANCOVA|||Day 6 analyses||-0.29|-0.84|
71086433|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.56|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.29|0.83|||ANCOVA|||Day 6 analyses||0.83|0.29|
71086434|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.08|0.46|||ANCOVA|||Day 6 analyses||0.46|-0.08|
71086435|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.28|0.26|||ANCOVA|||Day 6 analyses||0.26|-0.28|
71086436|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.61|-0.04|||ANCOVA|||Day 7 analyses||-0.04|-0.61|
71086437|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.92|-0.34|||ANCOVA|||Day 7 analyses||-0.34|-0.92|
71086438|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.21|0.78|||ANCOVA|||Day 7 analyses||0.78|0.21|
71086439|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.11|0.45|||ANCOVA|||Day 7 analyses||0.45|-0.11|
71086440|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.42|0.15|||ANCOVA|||Day 7 analyses||0.15|-0.42|
71086441|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.57|0.0|||ANCOVA|||Day 8 analyses||-0.00|-0.57|
71086442|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.84|-0.27|||ANCOVA|||Day 8 analyses||-0.27|-0.84|
71086443|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.14|0.7|||ANCOVA|||Day 8 analyses||0.70|0.14|
71086444|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.15|0.41|||ANCOVA|||Day 8 analyses||0.41|-0.15|
71086445|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.42|0.14|||ANCOVA|||Day 8 analyses||0.14|-0.42|
71086446|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.61|-0.02|||ANCOVA|||Day 9 analyses||-0.02|-0.61|
71086447|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.82|-0.23|||ANCOVA|||Day 9 analyses||-0.23|-0.82|
71086448|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|0.18|0.76|||ANCOVA|||Day 9 analyses||0.76|0.18|
71086449|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.13|0.44|||ANCOVA|||Day 9 analyses||0.44|-0.13|
71086450|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.35|0.23|||ANCOVA|||Day 9 analyses||0.23|-0.35|
71086451|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.59|0.01|||ANCOVA|||Day 10 analyses||0.01|-0.59|
71086452|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.76|-0.16|||ANCOVA|||Day 10 analyses||-0.16|-0.76|
71086453|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|0.1|0.69|||ANCOVA|||Day 10 analyses||0.69|0.10|
71086454|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.18|0.41|||ANCOVA|||Day 10 analyses||0.41|-0.18|
71086455|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.36|0.23|||ANCOVA|||Day 10 analyses||0.23|-0.36|
71086456|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.56|0.05|||ANCOVA|||Day 11 analyses||0.05|-0.56|
71086457|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.77|-0.17|||ANCOVA|||Day 11 analyses||-0.17|-0.77|
71086458|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|0.1|0.69|||ANCOVA|||Day 11 analyses||0.69|0.10|
71086459|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.16|0.44|||ANCOVA|||Day 11 analyses||0.44|-0.16|
71086460|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.37|0.23|||ANCOVA|||Day 11 analyses||0.23|-0.37|
71086461|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.53|0.09|||ANCOVA|||Day 12 analyses||0.09|-0.53|
71124139|NCT02573246|141754105|SUPERIORITY||Mean Difference (Net)|10.46|STANDARD_ERROR_OF_MEAN|7.93||0.2|TWO_SIDED|95.0|-5.971581|26.892619||threshold was set to 0.05 a priori|Mixed Models Analysis||HLM models used a compound symmetry covariance structure.|||26.892619|-5.971581|.20
71124140|NCT02573246|141754106|SUPERIORITY||Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|0.258||0.034|TWO_SIDED|95.0|-1.062356|-0.043203||A priori threshold was set to .05 for significance.|Mixed Models Analysis|Subjective Units of Distress (SUDS) right before the intervention were co-varied as baseline.|Results reported are for active left vs. sham comparison.|Hypothesized that active neurostimulation would lead to lower daily distress than sham stimulation. We used a hierarchical linear model (HLM) for this analysis with an identity covariance structure (random intercept and random slope).||-0.043203|-1.062356|.034
71124141|NCT02573246|141754106|SUPERIORITY||Mean Difference (Net)|0.631|STANDARD_ERROR_OF_MEAN|0.404||0.133|TWO_SIDED|95.0|-0.208|1.47||A priori set threshold was .05|Mixed Models Analysis|||Hypothesized that active neurostimulation will lead to less daily distress than sham neurostimulation during the ambulatory data collection. An HLM analysis was conducted using an unstructured covariance structure and reported distress right before the intervention as baseline.||1.47|-.208|.133
71124142|NCT02573246|141754107|SUPERIORITY||Mean Difference (Net)|-1.300772|STANDARD_ERROR_OF_MEAN|2.670936||0.629061|TWO_SIDED|95.0|-6.708548|4.107||A priori threshold was set to .05|Mixed Models Analysis|Intake values for the dependent measures were covaried. The time by condition interaction term was included.||Mixed model analyses of variance (MMANOVAs) were conducted to explore the difference between active and sham neurostimulation on self reported indices of regulation and psychopathology. We expected active neurostimulation to lead to less functional impairment than sham neurostimulation.||4.107|-6.708548|0.629061
71124143|NCT02573246|141754107|SUPERIORITY||Mean Difference (Net)|-0.977394|STANDARD_ERROR_OF_MEAN|2.605189||0.71|TWO_SIDED|95.0|-6.255223|4.300434|||Mixed Models Analysis|||We expected lower functional impairment in the active right versus the sham condition.||4.300434|-6.255223|0.71
71124144|NCT02573246|141754107|SUPERIORITY||Mean Difference (Net)|-3.292137|STANDARD_ERROR_OF_MEAN|3.314194||0.331|TWO_SIDED|95.0|-10.157811|3.573537||A priori set threshold was .05|Mixed Models Analysis|Baseline WSAS was covaried|The analysis compared sham versus active stimulation.|Mixed model analyses of variance (MMANOVAs) were conducted to explore the difference between active and sham neurostimulation on self reported indices of regulation and psychopathology in the substudy also. We expected active neurostimulation to lead to less impairment than sham neurostimulation.||3.573537|-10.157811|0.331
71124145|NCT02573246|141754107|SUPERIORITY||Mean Difference (Net)|0.284589|STANDARD_ERROR_OF_MEAN|0.276698||0.31|TWO_SIDED|95.0|-0.27603|0.845209||A priori set threshold for significance was 0.05|Mixed Models Analysis|baseline was covaried||Mixed model analyses of variance (MMANOVAs) were conducted to explore the difference between active and sham neurostimulation on self reported indices of regulation and psychopathology. We expected active neurostimulation to lead to more use of cognitive restructuring than sham neurostimulation.||0.845209|-0.276030|0.31
71124146|NCT02573246|141754107|SUPERIORITY||Mean Difference (Net)|10.129377|STANDARD_ERROR_OF_MEAN|9.150339||0.275257|TWO_SIDED|95.0|-8.394724|28.653479|||Mixed Models Analysis|||We hypothesized that active right neurostimulation would yield lower emotional dysregulation after the intervention when compared to sham neurostimulation.||28.653479|-8.394724|0.275257
71124147|NCT02573246|141754107|SUPERIORITY||Mean Difference (Net)|-13.187|STANDARD_ERROR_OF_MEAN|6.212753||0.044|TWO_SIDED|95.0|-26.002351|-0.372281||A priori set significance threshold was 0.05|Mixed Models Analysis|||Mixed model analyses of variance (MMANOVAs) were conducted to explore the difference between active and sham neurostimulation on self reported indices of regulation and psychopathology. We expected active neurostimulation to lead to less emotional dysregulation than sham neurostimulation.||-0.372281|-26.002351|0.044
71124148|NCT02573246|141754107|SUPERIORITY||Mean Difference (Net)|0.927909|STANDARD_ERROR_OF_MEAN|9.603423||0.924|TWO_SIDED|95.0|-18.508252|20.364071||A priori set threshold for statistical significance was 0.05|Mixed Models Analysis|baseline was covaried||We expected active stimulation to lead to less emotional dysregulation than sham neurostimulation. A MMANOVA model was employed, controlling for baseline.||20.364071|-18.508252|.924
71124149|NCT02573246|141754107|SUPERIORITY||Mean Difference (Net)|-0.017547|STANDARD_ERROR_OF_MEAN|0.267983||0.95|TWO_SIDED|95.0|-0.560994|0.525901|||Mixed Models Analysis|||we expected more use of cr following active right neurostimulation then after following sham neurostimulation.||0.525901|-0.560994|.95
71124150|NCT02573246|141754107|SUPERIORITY||Mean Difference (Net)|-0.096719|STANDARD_ERROR_OF_MEAN|0.389897||0.806|TWO_SIDED|95.0|-0.900919|0.707481||A priori set significance threshold was 0.05|Mixed Models Analysis|Baseline use of cognitive restructuring was covaried||Mixed model analyses of variance (MMANOVAs) were conducted to explore the difference between active and sham neurostimulation on self reported indices of regulation and psychopathology. We expected active neurostimulation to lead to more use of cognitive restructuring than sham neurostimulation.||0.707481|-0.900919|.806
71124151|NCT00316888|141754143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.218|||||||one sample binomial test|||Null hypothesis is that the local failure rate at 3 years is no more than 35%.||||0.218
71124152|NCT00316888|141754143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.592|||||||one sample binomial test|||The null hypothesis is that the local failure rate at 3 years is no more than 35%.||||0.592
71086462|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.77|-0.15|||ANCOVA|||Day 12 analyses||-0.15|-0.77|
70856930|NCT02446743|141200493|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1(V72\_41)\]|vaccine group differences|12.0|||||TWO_SIDED|95.0|0.33|24.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||24.2|0.33|
70945220|NCT01393613|141390954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.59||||0.0005|TWO_SIDED|95.0|2.02|7.17|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||7.17|2.02|0.0005
71086463|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.04|0.57|||ANCOVA|||Day 12 analyses||0.57|-0.04|
71086464|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.25|0.36|||ANCOVA|||Day 12 analyses||0.36|-0.25|
71086465|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.5|0.11|||ANCOVA|||Day 12 analyses||0.11|-0.50|
71086466|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.56|0.07|||ANCOVA|||Day 13/Early Termination analyses||0.07|-0.56|
71086467|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.81|-0.19|||ANCOVA|||Day 13/Early Termination analyses||-0.19|-0.81|
71086468|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.1|0.51|||ANCOVA|||Day 13/Early Termination analyses||0.51|-0.10|
71086469|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.35|0.26|||ANCOVA|||Day 13/Early Termination analyses||0.26|-0.35|
71086470|NCT00549549|141678550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.6|0.01|||ANCOVA|||Day 13/Early Termination analyses||0.01|-0.60|
71086471|NCT00549549|141678551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.28|0.14|||ANCOVA|||The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.||0.14|-0.28|
71086472|NCT00549549|141678551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.39|0.03|||ANCOVA|||Day 1, 2 hours postdose||0.03|-0.39|
71086473|NCT00549549|141678551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|0.11|0.52|||ANCOVA|||Day 1, 2 hours postdose||0.52|0.11|
71086474|NCT00549549|141678551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|0.04|0.45|||ANCOVA|||Day 1, 2 hours postdose||0.45|0.04|
71086475|NCT00549549|141678551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.08|0.34|||ANCOVA|||Day 1, 2 hours postdose||0.34|-0.08|
71086476|NCT00549549|141678551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.37|0.08|||ANCOVA|||Day 1, 4 hours postdose||0.08|-0.37|
71086477|NCT00549549|141678551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.48|-0.03|||ANCOVA|||Day 1, 4 hours postdose||-0.03|-0.48|
71086478|NCT00549549|141678551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|0.14|0.58|||ANCOVA|||Day 1, 4 hours postdose||0.58|0.14|
71086479|NCT00549549|141678551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|0.0|0.44|||ANCOVA|||Day 1, 4 hours postdose||0.44|0.00|
71086480|NCT00549549|141678551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.11|0.34|||ANCOVA|||Day 1, 4 hours postdose||0.34|-0.11|
71086481|NCT00549549|141678551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.32|0.17|||ANCOVA|||Day 1, 8 hours postdose||0.17|-0.32|
71086482|NCT00549549|141678551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.56|-0.06|||ANCOVA|||Day 1, 8 hours postdose||-0.06|-0.56|
71086483|NCT00549549|141678551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|0.18|0.67|||ANCOVA|||Day 1, 8 hours postdose||0.67|0.18|
71086484|NCT00549549|141678551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|0.11|0.59|||ANCOVA|||Day 1, 8 hours postdose||0.59|0.11|
71086485|NCT00549549|141678551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.13|0.36|||ANCOVA|||Day 1, 8 hours postdose||0.36|-0.13|
71086486|NCT00549549|141678551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.42|0.1|||ANCOVA|||Day 1, 12 hours postdose||0.10|-0.42|
71086487|NCT00549549|141678551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.63|-0.11|||ANCOVA|||Day 1, 12 hours postdose||-0.11|-0.63|
71086488|NCT00549549|141678551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.19|0.7|||ANCOVA|||Day 1, 12 hours postdose||0.70|0.19|
71086489|NCT00549549|141678551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.03|0.55|||ANCOVA|||Day 1, 12 hours postdose||0.55|0.03|
71086490|NCT00549549|141678551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.18|0.34|||ANCOVA|||Day 1, 12 hours postdose||0.34|-0.18|
71086491|NCT00549549|141678551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.46|0.07|||ANCOVA|||Day 2, 0 hours postdose||0.07|-0.46|
71086492|NCT00549549|141678551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.57|-0.04|||ANCOVA|||Day 2, 0 hours postdose||-0.04|-0.57|
71124153|NCT04135859|141754156|SUPERIORITY||Mean Difference (Final Values)|10.3||||0.023|TWO_SIDED||||||Mixed Models Analysis|||||||.023
70856931|NCT02446743|141200493|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1(V72P10)\]|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-10.0|9.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||9.5|-10.0|
71086493|NCT00549549|141678551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.16|0.68|||ANCOVA|||Day 2, 0 hours postdose||0.68|0.16|
71124154|NCT04135859|141754157|SUPERIORITY||Mean Difference (Final Values)|-59.0||||0.06|TWO_SIDED||||||Mixed Models Analysis|||||||.06
71124155|NCT04135859|141754158|SUPERIORITY||Mean Difference (Final Values)|-0.76||||0.43|TWO_SIDED||||||Mixed Models Analysis|||||||.43
71124156|NCT01291836|141754159|SUPERIORITY_OR_OTHER_LEGACY||Area under Receiver-Operator Curve (ROC)|0.658|||||TWO_SIDED|95.0|0.586|0.73||||||Null Hypothesis: ROC AUC of 0.58; using a one-sided z-test at a significance level of 0.025. Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1.|Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1.|0.73|0.586|
71124157|NCT01291836|141754160|SUPERIORITY_OR_OTHER_LEGACY||ROC AUC|0.65|||||TWO_SIDED|95.0|0.598|0.702||||||Null Hypothesis: AUC ≤0.55, using a one-sided z-test at a significance level of 0.025. Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1.|Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1.|0.702|0.598|
71124158|NCT03242018|141754201|SUPERIORITY||Difference in Least Square (LS) Means|-0.29|STANDARD_ERROR_OF_MEAN|0.173||0.0962|TWO_SIDED|95.0|-0.628|0.051|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||0.051|-0.628|0.0962
71124159|NCT03242018|141754202|SUPERIORITY||Difference in LS Means|0.05|STANDARD_ERROR_OF_MEAN|0.196||0.8124|TWO_SIDED|95.0|-0.338|0.431|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||0.431|-0.338|0.8124
71124160|NCT03242018|141754203|SUPERIORITY||Difference in LS Means|-0.361|STANDARD_ERROR_OF_MEAN|0.6033||0.5501|TWO_SIDED|95.0|-1.5431|0.822|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline FPG as a covariate.||0.8220|-1.5431|0.5501
71124161|NCT03242018|141754203|SUPERIORITY||Difference in LS Means|-0.714|STANDARD_ERROR_OF_MEAN|0.5298||0.1779|TWO_SIDED|95.0|-1.7524|0.3246|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline FPG as a covariate.||0.3246|-1.7524|0.1779
71124162|NCT03242018|141754204|SUPERIORITY||Difference in LS Means|-0.82|STANDARD_ERROR_OF_MEAN|0.703||0.2432|TWO_SIDED|95.0|-2.197|0.557|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline body weight as a covariate.||0.557|-2.197|0.2432
71124163|NCT03242018|141754204|SUPERIORITY||Difference in LS Means|-1.41|STANDARD_ERROR_OF_MEAN|0.715||0.0487|TWO_SIDED|95.0|-2.81|-0.008|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline body weight as a covariate.||-0.008|-2.810|0.0487
71124164|NCT03242018|141754205|SUPERIORITY||Difference in LS Means|-2.14|STANDARD_ERROR_OF_MEAN|2.515||0.3954|TWO_SIDED|95.0|-7.066|2.792|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, and country as fixed effects, and baseline SBP as a covariate.||2.792|-7.066|0.3954
71124165|NCT03242018|141754205|SUPERIORITY||Difference in LS Means|-4.4|STANDARD_ERROR_OF_MEAN|2.442||0.0716|TWO_SIDED|95.0|-9.185|0.386|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, and country as fixed effects, and baseline SBP as a covariate.||0.386|-9.185|0.0716
71124166|NCT03242018|141754206|SUPERIORITY||Difference in LS Means|-3.24|STANDARD_ERROR_OF_MEAN|2.103||0.1232|TWO_SIDED|95.0|-7.365|0.881|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline SBP as a covariate.||0.881|-7.365|0.1232
71124167|NCT03242018|141754206|SUPERIORITY||Difference in LS Means|-5.36|STANDARD_ERROR_OF_MEAN|2.077||0.0098|TWO_SIDED|95.0|-9.433|-1.292|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline SBP as a covariate.||-1.292|-9.433|0.0098
71124168|NCT03242018|141754207|SUPERIORITY||Percent Difference|-20.37||||0.222|TWO_SIDED|95.0|-44.75|14.77|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and log-transformed baseline UACR as a covariate.||14.77|-44.75|0.222
71086494|NCT00549549|141678551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.04|0.49|||ANCOVA|||Day 2, 0 hours postdose||0.49|-0.04|
71086495|NCT00549549|141678551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.15|0.38|||ANCOVA|||Day 2, 0 hours postdose||0.38|-0.15|
71086496|NCT00549549|141678551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.4|0.14|||ANCOVA|||Day 2, 8 hours postdose||0.14|-0.40|
71086497|NCT00549549|141678551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.59|-0.05|||ANCOVA|||Day 2, 8 hours postdose||-0.05|-0.59|
71086498|NCT00549549|141678551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.2|0.74|||ANCOVA|||Day 2, 8 hours postdose||0.74|0.20|
71086499|NCT00549549|141678551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.08|0.61|||ANCOVA|||Day 2, 8 hours postdose||0.61|0.08|
71086500|NCT00549549|141678551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.11|0.42|||ANCOVA|||Day 2, 8 hours postdose||0.42|-0.11|
71086501|NCT00549549|141678552|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.09|0.27|||ANCOVA|||8 hour postdose analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.||0.27|-0.09|
71086502|NCT00549549|141678552|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|0.04|0.4|||ANCOVA|||8 hour postdose analysis||0.40|0.04|
71086503|NCT00549549|141678552|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.5|-0.14|||ANCOVA|||8 hour postdose analysis||-0.14|-0.50|
71086504|NCT00549549|141678552|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.41|-0.05|||ANCOVA|||8 hour postdose analysis||-0.05|-0.41|
71086505|NCT00549549|141678552|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.28|0.08|||ANCOVA|||8 hour postdose analysis||0.08|-0.28|
71086506|NCT00549549|141678552|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.1|0.29|||ANCOVA|||12 hour postdose analysis||0.29|-0.10|
71086507|NCT00549549|141678552|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|0.06|0.45|||ANCOVA|||12 hour postdose analysis||0.45|0.06|
71086508|NCT00549549|141678552|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.55|-0.16|||ANCOVA|||12 hour postdose analysis||-0.16|-0.55|
71086509|NCT00549549|141678552|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.45|-0.07|||ANCOVA|||12 hour postdose analysis||-0.07|-0.45|
71086510|NCT00549549|141678552|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.29|0.09|||ANCOVA|||12 hour postdose analysis||0.09|-0.29|
71124169|NCT03242018|141754207|SUPERIORITY||Percent Difference|-21.17||||0.1965|TWO_SIDED|95.0|-45.05|13.1|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and log-transformed baseline UACR as a covariate.||13.10|-45.05|0.1965
71124170|NCT03242018|141754208|SUPERIORITY||Percentage Difference|3.2||||0.242|TWO_SIDED|95.0|-2.17|8.66|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), and the randomization strata of mean SBP (\<130, ≥130 mmHg) at screening.||8.66|-2.17|0.2420
71086511|NCT00549549|141678552|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.08|0.35|||ANCOVA|||24 hour postdose analysis||0.35|-0.08|
71086512|NCT00549549|141678552|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|0.08|0.51|||ANCOVA|||24 hour postdose analysis||0.51|0.08|
71124171|NCT03242018|141754208|SUPERIORITY||Percentage Difference|6.5||||0.0513|TWO_SIDED|95.0|0.04|12.93|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), and the randomization strata of mean SBP (\<130, ≥130 mmHg) at screening.||12.93|0.04|0.0513
71124172|NCT03242018|141754209|SUPERIORITY||Percentage Difference|12.0||||0.0066|TWO_SIDED|95.0|3.48|20.61|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), and the randomization strata of mean SBP (\<130, ≥130 mmHg) at screening.||20.61|3.48|0.0066
71086513|NCT00549549|141678552|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.61|-0.18|||ANCOVA|||24 hour postdose analysis||-0.18|-0.61|
71086514|NCT00549549|141678552|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.47|-0.05|||ANCOVA|||24 hour postdose analysis||-0.05|-0.47|
71086515|NCT00549549|141678552|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.32|0.11|||ANCOVA|||24 hour postdose analysis||0.11|-0.32|
71086516|NCT00549549|141678553|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0459|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=30% reduction analyses. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.||||0.0459
71086517|NCT00549549|141678553|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=30% reduction analyses||||0.0017
71086518|NCT00549549|141678553|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=30% reduction analyses||||0.0001
71086519|NCT00549549|141678553|SUPERIORITY_OR_OTHER_LEGACY|||||||0.041|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=30% reduction analyses||||0.0410
71086520|NCT00549549|141678553|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5592|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=30% reduction analyses||||0.5592
71086521|NCT00549549|141678553|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0277|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=50% reduction analyses||||0.0277
71086522|NCT00549549|141678553|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0018|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=50% reduction analyses||||0.0018
71086523|NCT00549549|141678553|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=50% reduction analyses||||<.0001
71086524|NCT00549549|141678553|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0394|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=50% reduction analyses||||0.0394
71086525|NCT00549549|141678553|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4603|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=50% reduction analyses||||0.4603
71086526|NCT00549549|141678556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5528|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on Day 1. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.5528
71086527|NCT00549549|141678556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1779|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on Day 1. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.1779
71086528|NCT00549549|141678556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1754|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on Day 1. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.1754
71086529|NCT00549549|141678556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3384|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on Day 1. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.3384
71086530|NCT00549549|141678556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5005|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.5005
70945221|NCT01393613|141390954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.1286|TWO_SIDED|95.0|-0.58|4.59|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||4.59|-0.58|0.1286
70945222|NCT01393613|141390954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.21||||0.0332|TWO_SIDED|95.0|0.26|6.16|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||6.16|0.26|0.0332
71086531|NCT00549549|141678556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0845|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.0845
71086532|NCT00549549|141678556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0213|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.0213
71086533|NCT00549549|141678556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1231|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.1231
71124173|NCT03242018|141754209|SUPERIORITY||Percentage Difference|13.0||||0.0043|TWO_SIDED|95.0|4.28|21.75|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), and the randomization strata of mean SBP (\<130, ≥130 mmHg) at screening.||21.75|4.28|0.0043
71124174|NCT02968914|141754222|SUPERIORITY||Geometric mean ratio (%)|94.46|||||TWO_SIDED|90.0|88.16|101.21|||ANOVA|||||101.21|88.16|
71124175|NCT02968914|141754223|SUPERIORITY||Geometric mean ratio (%)|92.83|||||TWO_SIDED|90.0|87.41|98.58|||ANOVA|||||98.58|87.41|
71124176|NCT02968914|141754224|SUPERIORITY||Geometric mean ratio (%)|92.34|||||TWO_SIDED|90.0|86.34|98.75|||ANOVA|||||98.75|86.34|
70945223|NCT01393613|141390955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.0166|TWO_SIDED|95.0|-3.08|-0.31|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.31|-3.08|0.0166
70945224|NCT01393613|141390955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.5101|TWO_SIDED|95.0|-1.86|0.93|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||0.93|-1.86|0.5101
70945225|NCT01393613|141390955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.3938|TWO_SIDED|95.0|-2.26|0.89|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.89|-2.26|0.3938
70945226|NCT01393613|141390956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22||||0.0231|TWO_SIDED|95.0|-2.28|-0.17|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.17|-2.28|0.0231
70945227|NCT01393613|141390956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77||||0.1547|TWO_SIDED|95.0|-1.83|0.29|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||0.29|-1.83|0.1547
70945228|NCT01393613|141390956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.2004|TWO_SIDED|95.0|-1.98|0.42|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.42|-1.98|0.2004
70945229|NCT01393613|141390957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0009|TWO_SIDED|95.0|-0.78|-0.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenzel (CMH) row mean scores differ test controlling for study center.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.20|-0.78|0.0009
70945230|NCT01393613|141390957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.0422|TWO_SIDED|95.0|-0.6|-0.01|||Cochran-Mantel-Haenszel|CMH row mean scores differ test controlling for study center.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||-0.01|-0.60|0.0422
70945231|NCT01393613|141390957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.1358|TWO_SIDED|95.0|-0.56|0.08|||Cochran-Mantel-Haenszel|CMH row mean scores differ test controlling for study center.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.08|-0.56|0.1358
70945232|NCT01393613|141390958|SUPERIORITY_OR_OTHER||Relative Risk|1.54||||0.0006|TWO_SIDED|95.0|1.2|2.0|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||2.00|1.20|0.0006
71086534|NCT00549549|141678556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6636|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.6636
70945233|NCT01393613|141390958|SUPERIORITY_OR_OTHER||Relative Risk|1.22||||0.168|TWO_SIDED|95.0|0.92|1.62|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||1.62|0.92|0.1680
70945234|NCT01393613|141390958|SUPERIORITY_OR_OTHER||Relative Risk|1.35||||0.0433|TWO_SIDED|95.0|1.02|1.79|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||1.79|1.02|0.0433
70945235|NCT01393613|141390959|SUPERIORITY_OR_OTHER||Relative Risk|0.82||||0.5202|TWO_SIDED|95.0|0.44|1.51|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||1.51|0.44|0.5202
70945236|NCT01393613|141390959|SUPERIORITY_OR_OTHER||Relative Risk|1.0||||0.9894|TWO_SIDED|95.0|0.55|1.85|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||1.85|0.55|0.9894
70945237|NCT01393613|141390959|SUPERIORITY_OR_OTHER||Relative Risk|0.76||||0.4586|TWO_SIDED|95.0|0.36|1.59|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||1.59|0.36|0.4586
70945238|NCT01393613|141390960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39||||0.0029|TWO_SIDED|95.0|-2.3|-0.48|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.48|-2.30|0.0029
70945239|NCT01393613|141390960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.3559|TWO_SIDED|95.0|-1.34|0.48|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||0.48|-1.34|0.3559
70945240|NCT01393613|141390960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.3646|TWO_SIDED|95.0|-1.51|0.56|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.56|-1.51|0.3646
70945241|NCT01393613|141390961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14||||0.1273|TWO_SIDED|95.0|-2.61|0.33|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||0.33|-2.61|0.1273
70945242|NCT01393613|141390961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.64|TWO_SIDED|95.0|-1.83|1.12|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||1.12|-1.83|0.6400
70945243|NCT01393613|141390961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.4423|TWO_SIDED|95.0|-2.32|1.01|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||1.01|-2.32|0.4423
70945244|NCT01393613|141390962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.0194|TWO_SIDED|95.0|-2.36|-0.21|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.21|-2.36|0.0194
71124177|NCT02636946|141754232|NON_INFERIORITY|MMRM was used for IOP change from baseline. The model includes IOP change from baseline as the response variable and treatment, visit, eye, baseline IOP, treatment-by-baseline, treatment-by-eye, treatment-by-visit, visit-by-eye interactions as covariates. A Kronecker product of unstructured covariance matrix for study visit and compound symmetry covariance matrix for between eye correlation was used in the analysis.|Least-squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.29||0.0166|TWO_SIDED|95.0|-1.28|-0.13|||MMRM|||Change from Baseline at Week 4: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to SLT if the upper limit of the 95% CI was ≤ 1.5 mmHg at all scheduled visits (Weeks 4, 12, and 24).||-0.13|-1.28|0.0166
70945245|NCT01393613|141390962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98||||0.0754|TWO_SIDED|95.0|-2.06|0.1|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||0.10|-2.06|0.0754
70945246|NCT01393613|141390962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.108|TWO_SIDED|95.0|-2.22|0.22|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.22|-2.22|0.1080
70945247|NCT01393613|141390963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39||||0.0045|TWO_SIDED|95.0|-2.34|-0.43|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6. Because only the comparison of brexpiprazole 4 mg/day versus placebo met the threshold in the primary analysis, the following analysis is not part for the formal statistical testing and is descriptive only.||-0.43|-2.34|0.0045
70945248|NCT01393613|141390963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.4753|TWO_SIDED|95.0|-1.31|0.61|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||0.61|-1.31|0.4753
70945249|NCT01393613|141390963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87||||0.115|TWO_SIDED|95.0|-1.96|0.21|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.21|-1.96|0.1150
71124178|NCT02636946|141754233|NON_INFERIORITY|MMRM was used for IOP change from baseline. The model includes IOP change from baseline as the response variable and treatment, visit, eye, baseline IOP, treatment-by-baseline, treatment-by-eye, treatment-by-visit, visit-by-eye interactions as covariates. A Kronecker product of unstructured covariance matrix for study visit and compound symmetry covariance matrix for between eye correlation was used in the analysis.|Least-squares Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.29||0.0735|TWO_SIDED|95.0|-1.09|0.05|||MMRM|||Change from Baseline at Week 12: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to SLT if the upper limit of the 95% CI was ≤ 1.5 mmHg at all scheduled visits (Weeks 4, 12, and 24).||0.05|-1.09|0.0735
71124179|NCT02636946|141754234|NON_INFERIORITY|MMRM was used for IOP change from baseline. The model includes IOP change from baseline as the response variable and treatment, visit, eye, baseline IOP, treatment-by-baseline, treatment-by-eye, treatment-by-visit, visit-by-eye interactions as covariates. A Kronecker product of unstructured covariance matrix for study visit and compound symmetry covariance matrix for between eye correlation was used in the analysis.|Least-squares Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.29||0.3928|TWO_SIDED|95.0|-0.81|0.32|||MMRM|||Change from Baseline at Week 24: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to SLT if the upper limit of the 95% confidence interval (CI) was ≤ 1.5 mmHg at all scheduled visits (Weeks 4, 12, and 24).||0.32|-0.81|0.3928
71124180|NCT00121641|141754244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.9|-0.33||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-0.33|-0.90|<.0001
71124181|NCT00121641|141754244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.93|-0.36||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-0.36|-0.93|<.0001
71124182|NCT00121641|141754244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.02|-0.44||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-0.44|-1.02|<.0001
71124183|NCT00121641|141754245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.6|STANDARD_ERROR_OF_MEAN|5.53||0.0002|TWO_SIDED|95.0|-31.47|-9.72||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-9.72|-31.47|0.0002
71124184|NCT00121641|141754245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.73|STANDARD_ERROR_OF_MEAN|5.48||0.0074|TWO_SIDED|95.0|-25.5|-3.97||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-3.97|-25.50|0.0074
71124185|NCT00121641|141754245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.81|STANDARD_ERROR_OF_MEAN|5.58|<|0.0001|TWO_SIDED|95.0|-33.79|-11.84||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-11.84|-33.79|<.0001
71124186|NCT00121641|141754246|SUPERIORITY_OR_OTHER||Difference in Proportions|11.1||||0.1141|TWO_SIDED|95.0|-3.1|24.9||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.||||24.9|-3.1|0.1141
71124187|NCT00121641|141754246|SUPERIORITY_OR_OTHER||Difference in Proportions|14.0||||0.0443|TWO_SIDED|95.0|-0.1|27.6||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.||||27.6|-0.1|0.0443
71124188|NCT00121641|141754246|SUPERIORITY_OR_OTHER||Difference in Proportions|17.1||||0.0133|TWO_SIDED|95.0|2.8|31.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.||||31.0|2.8|0.0133
70945250|NCT01393613|141390964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26||||0.0021|TWO_SIDED|95.0|-2.05|-0.46|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.46|-2.05|0.0021
70945251|NCT01393613|141390964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.6792|TWO_SIDED|95.0|-0.97|0.63|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||0.63|-0.97|0.6792
70945252|NCT01393613|141390964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.5752|TWO_SIDED|95.0|-1.16|0.65|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.65|-1.16|0.5752
70945253|NCT01393613|141390965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86||||0.0104|TWO_SIDED|95.0|-1.51|-0.2|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.20|-1.51|0.0104
70945254|NCT01393613|141390965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.0373|TWO_SIDED|95.0|-1.35|-0.04|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||-0.04|-1.35|0.0373
71124189|NCT00121641|141754247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6221.0|STANDARD_ERROR_OF_MEAN|1701.3||0.0003|TWO_SIDED|95.0|-9570.0|-2872.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-2872|-9570|0.0003
71124190|NCT00121641|141754247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6249.0|STANDARD_ERROR_OF_MEAN|1675.1||0.0002|TWO_SIDED|95.0|-9546.0|-2952.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-2952|-9546|0.0002
71124191|NCT00121641|141754247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7437.0|STANDARD_ERROR_OF_MEAN|1707.6|<|0.0001|TWO_SIDED|95.0|-10798.0|-4076.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-4076|-10798|<.0001
71124192|NCT01792518|141754282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.78|-0.43|||Mixed Models Analysis|The Unstructured covariance structure has been used to fit the mixed model|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Linagliptin 5 mg minus Placebo.|Superiority of Linagliptin 5 mg vs. placebo: change in HbA1c is analysed using mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c, baseline log10 (UACR), baseline HbA1c by visit and baseline log10 (UACR) by visit as linear covariates and treatment, visit, visit by treatment interaction as fixed effects.||-0.43|-0.78|<0.0001
71124193|NCT01792518|141754283|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.94||||0.1954|TWO_SIDED|95.0|0.85|1.03|||ANCOVA||Ratio of relative change for Linagliptin 5 mg over placebo is presented.|Superiority of Linagliptin 5 mg vs. placebo: change in UACR is analysed using analysis of covariance model. Model includes baseline HbA1c and baseline log10 (UACR) as linear covariates and treatment as fixed effect.||1.03|0.85|0.1954
71124194|NCT01792518|141754284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|2.7||0.3306|TWO_SIDED|95.0|-7.95|2.68|||Mixed Models Analysis|The Unstructured covariance structure has been used to fit the mixed model|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Linagliptin 5 mg minus Placebo.|Change in eGFR is analysed using mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c, baseline log10 (UACR), baseline eGFR, baseline HbA1c by visit, baseline log10 (UACR) by visit and baseline eGFR by visit as linear covariates and treatment, visit, visit by treatment interaction as fixed effects.||2.68|-7.95|0.3306
71124195|NCT04468074|141754285|SUPERIORITY||Mean Difference (Net)|1.0||||0.014|TWO_SIDED||||||Mixed Models Analysis|||||||0.014
70945255|NCT01393613|141390965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.089|TWO_SIDED|95.0|-1.39|0.1|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.10|-1.39|0.0890
70945256|NCT01502371|141391000|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.87||||0.019|TWO_SIDED|95.0|0.64|7.09||Constrained longitudinal data analysis (cLDA) model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA model|||Change from Baseline in percent predicted FEV1 at Week 12: MF MDI 50 mcg BID vs. Placebo||7.09|0.64|0.019
70945257|NCT01502371|141391000|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.29|||<|0.001|TWO_SIDED|95.0|3.05|9.53||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in percent predicted FEV1 at Week 12: MF MDI 100 mcg BID vs. Placebo||9.53|3.05|<0.001
71124196|NCT04468074|141754286|SUPERIORITY||Mean Difference (Net)|2.79||||0.0159|TWO_SIDED||||||Mixed Models Analysis|||||||0.0159
71124197|NCT04468074|141754287|SUPERIORITY||Median Difference (Net)|-3.85||||0.0066|TWO_SIDED||||||Mixed Models Analysis|||||||0.0066
71124198|NCT00915148|141754310|SUPERIORITY_OR_OTHER||||||<|0.01||||||The reported p-value corresponds with each area under the ROC assessments|Chi-squared|||In a previous study we investigated women before induction of labor. Using 40 mm as cut-off level for fetal head - perineum distance, the Cesarean section rate in primiparous women was 7% in the group with a short distance and 27% in the group with a long distance. We assumed similar results, with alpha 0.05, power 0.8 and a ratio of 1 : 1 for the numbers of women with a long and short distance. We would need to include 110 women in the study.||||<0.01
70945258|NCT01502371|141391000|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.34||||0.001|TWO_SIDED|95.0|2.07|8.61||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in percent predicted FEV1 at Week 12: MF MDI 200 mcg BID vs. Placebo||8.61|2.07|0.001
70945259|NCT01502371|141391001|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|19.15||||0.045|TWO_SIDED|95.0|0.43|37.87||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in AM PEF: MF MDI 50 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.||37.87|0.43|0.045
70945260|NCT01502371|141391001|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|27.35||||0.004|TWO_SIDED|95.0|8.63|46.08||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in AM PEF: MF MDI 100 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.||46.08|8.63|0.004
70945261|NCT01502371|141391001|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|18.01||||0.057|TWO_SIDED|95.0|-0.51|36.53||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in AM PEF: MF MDI 200 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.||36.53|-0.51|0.057
70945262|NCT01502371|141391002|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1||||0.28|TWO_SIDED|95.0|-0.08|0.27||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in PAQLQ(S) Total Score: MF MDI 50 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.||0.27|-0.08|0.280
71124199|NCT00915148|141754311|SUPERIORITY_OR_OTHER||||||<|0.01||||||the reported p-value corresponds with each log rank comparison|Log Rank|||"Kaplan Meier plots were used to compare time from a defined prolonged labor in the first stage to delivery for~1. women with fetal head-perineum distance ≤40 mm vs. women with distance \>40 mm measured with 2D ultrasound.~2. women with angle of progression ≥110 degrees vs. women with angle \<110 degrees measured with 2D ultrasound"||||<0.01
71124200|NCT00249613|141754313|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4|STANDARD_ERROR_OF_MEAN|0.34||0.01|TWO_SIDED|95.0|0.21|0.79||Odds ratio is 0.40, confidence interval is 0.21-0.79.|Regression, Logistic||The direction of the comparison would dictate that odds ratio of less than 1 would indicate Women-Only participants are less likely than Mixed-Gender participants to engage in criminal activities.|Logistic regression does not separate arms because group status (women-only vs mixed gender) is the dependent variable in our multinomial logistic regression. Because we were not able to randomly assign after all, we also included a propensity score, and additional variables (substance use in past 30 days at baseline, age, race/ethnicity, childhood sexual abuse history, previous treatment, criminal justice funding source, and primary drug) to adjust for the non-random sampling.||0.79|0.21|0.01
71124201|NCT00249613|141754314|SUPERIORITY_OR_OTHER||Beta coefficient|-0.7|STANDARD_ERROR_OF_MEAN|0.72||0.33|TWO_SIDED|95.0|-2.11|0.7|||Generalized estimating equations (GEE)|||Generalized estimating equation (GEE) models do not separate arms: group status (women-only vs mixed-gender) is the dependent variable. Because we were not able to randomly assign, we also included a propensity score, and additional variables (education, race/ethnicity, marital status, income, history of sexual abuse, criminal justice funding source, had child, mental health symptoms, and a time in treatment by group interaction term) to adjust for the non-random sampling.||0.70|-2.11|0.33
71124202|NCT00249613|141754315|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42|STANDARD_ERROR_OF_MEAN|0.34||0.01|TWO_SIDED|95.0|0.22|0.82|||Regression, Logistic||The direction of the comparison would dictate that odds ratio of less than 1 would indicate Women-Only treatment participants are less likely than the Mixed-Gender group to use drugs or alcohol during the 30 days prior to the 12-Mo follow-up.|Logistic regression does not separate arms because group status (women-only vs mixed gender) is the dependent variable in our multinomial logistic regression. Because we were not able to randomly assign after all, we also included a propensity score, and additional variables (substance use in past 30 days at baseline, age, race/ethnicity, childhood sexual abuse history, previous treatment, criminal justice funding source, and primary drug) to adjust for the non-random sampling.||0.82|0.22|0.01
71124203|NCT01184417|141754333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.0|||||TWO_SIDED|95.0|4.0|32.0||||||||32|4|
71124204|NCT01184417|141754334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.0|||||TWO_SIDED|95.0|4.0|49.0||||||||49|4|
71124205|NCT01184417|141754335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.0|||||TWO_SIDED|95.0|-4.0|82.0||||||||82|-4|
71124206|NCT01184417|141754337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0|||||TWO_SIDED|95.0|-11.0|23.0||||||||23|-11|
70945263|NCT01502371|141391002|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.12||||0.178|TWO_SIDED|95.0|-0.06|0.3||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in PAQLQ(S) Total Score: MF MDI 100 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.||0.30|-0.06|0.178
70945264|NCT01502371|141391002|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.18||||0.045|TWO_SIDED|95.0|0.0|0.36||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in PAQLQ(S) Total Score: MF MDI 200 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.||0.36|0.00|0.045
70945265|NCT01502371|141391003|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.39||||0.368|TWO_SIDED|95.0|-1.65|4.44||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA model|||Change from Baseline in percent predicted FEV1 at Week 12: MF MDI 50 mcg BID vs. MF DPI 100 mcg QD. Only participants who received MF MDI 50 mcg BID or MF DPI 100 mcg QD were included in the statistical analysis.||4.44|-1.65|0.368
70945266|NCT02598934|141391009|SUPERIORITY_OR_OTHER||Difference in percentage of participants|16.9||||0.002|TWO_SIDED|95.0|6.1|27.7||P-value between Consult group and Non-consult group for the item in the BCS: ibandronate was effective in treating osteoporosis|Chi-squared, Corrected|||||27.7|6.1|0.002
70945267|NCT02598934|141391009|SUPERIORITY_OR_OTHER||Difference in percentage of participants|14.9||||0.009|TWO_SIDED|95.0|4.0|25.8||P-value between Consult group and Non-consult group for the item in the BCS: ibandronate reduces risk of breaking bone.|Chi-squared, Corrected|||||25.8|4.0|0.009
70945268|NCT02598934|141391009|SUPERIORITY_OR_OTHER||Difference in percentage of participants|16.9||||0.001|TWO_SIDED|95.0|6.3|27.5|||Chi-squared, Corrected|P-value between Consult group and Non-consult group for items in BCS: ibandronate effective in treating osteoporosis or reduces risk of breaking bone.||||27.5|6.3|0.001
70945269|NCT02598934|141391009|SUPERIORITY_OR_OTHER||Difference in percentage of participants|14.9||||0.01|TWO_SIDED|95.0|3.9|25.9||P-value between Consult group and Non-consult group for items in BCS: ibandronate effective in treating osteoporosis and reduces risk of breaking bone.|Chi-squared, Corrected|||||25.9|3.9|0.010
70945270|NCT02672514|141391010|SUPERIORITY_OR_OTHER|||||||0.377|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. The first blood samples from both groups were collected before cardiopulmonary bypass.||||0.377
70945271|NCT02672514|141391010|SUPERIORITY_OR_OTHER|||||||0.051|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. The blood samples were collected from both groups on arrival of intensive care unit.||||0.051
70945272|NCT02672514|141391010|SUPERIORITY_OR_OTHER|||||||0.282|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. The blood samples from both groups were collected 24 hours after Operation.||||0.282
70945273|NCT02672514|141391010|SUPERIORITY_OR_OTHER|||||||0.277|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. These blood samples were collected 48 hours after cardiopulmonary Bypass.||||0.277
70945274|NCT02672514|141391010|SUPERIORITY_OR_OTHER|||||||0.308|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. The blood samples were collected from both groups 72 hours after cardiopulmonary bypass.||||0.308
71086535|NCT00549549|141678556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5378|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.5378
71086536|NCT00549549|141678556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0818|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.0818
71124207|NCT01264770|141754363|SUPERIORITY_OR_OTHER||Treatment difference|0.56||||0.006|TWO_SIDED|90.0|0.23|0.9|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 6. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.||0.90|0.23|0.006
71124208|NCT01264770|141754363|SUPERIORITY_OR_OTHER||Treatment difference|0.49||||0.022|TWO_SIDED|90.0|0.14|0.84|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 6. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.||0.84|0.14|0.022
71124209|NCT01264770|141754363|SUPERIORITY_OR_OTHER||Treatment difference|0.22||||0.28|TWO_SIDED|90.0|-0.12|0.56|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 6. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.||0.56|-0.12|0.280
71124210|NCT01264770|141754364|NON_INFERIORITY_OR_EQUIVALENCE|For the comparison with adalimumab a non-inferiority margin of -0.6 in the mean change from baseline in DAS28-CRP at Week 24 was defined. The lower 80% confidence interval for treatment difference was below this value so non-inferiority could not be concluded. A p-value is also provided for a 2-sided test of superiority.|Treatment difference|-0.72||||0.005|TWO_SIDED|80.0|-1.04|-0.4|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 24. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.||-0.40|-1.04|0.005
71124211|NCT01264770|141754364|NON_INFERIORITY_OR_EQUIVALENCE|For the comparison with adalimumab a non-inferiority margin of -0.6 in the mean change from baseline in DAS28-CRP at Week 24 was defined. The lower 80% confidence interval for treatment difference was below this value so non-inferiority could not be concluded. A p-value is also provided for a 2-sided test of superiority.|Treatment difference|-0.61||||0.02|TWO_SIDED|80.0|-0.94|-0.27|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 24. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.||-0.27|-0.94|0.020
71124212|NCT01264770|141754364|NON_INFERIORITY_OR_EQUIVALENCE|For the comparison with adalimumab a non-inferiority margin of -0.6 in the mean change from baseline in DAS28-CRP at Week 24 was defined. The lower 80% confidence interval for treatment difference was below this value so non-inferiority could not be concluded. A p-value is also provided for a 2-sided test of superiority.|Treatment difference|-0.72||||0.004|TWO_SIDED|80.0|-1.04|-0.4|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 24. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.||-0.40|-1.04|0.004
71124213|NCT01264770|141754365|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.05||||0.005|TWO_SIDED|90.0|1.59|5.86|||Proportional odds model||An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||5.86|1.59|0.005
71124214|NCT01264770|141754365|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.11|||<|0.001|TWO_SIDED|90.0|2.1|8.05|||Proportional odds model||An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||8.05|2.10|<0.001
71124215|NCT01264770|141754365|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.335|TWO_SIDED|90.0|0.76|2.83|||Proportional odds model||An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.83|0.76|0.335
71124216|NCT01264770|141754366|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.37||||0.007|TWO_SIDED|90.0|0.2|0.68|||Proportional odds model||An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.68|0.20|0.007
71124217|NCT01264770|141754366|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48||||0.051|TWO_SIDED|90.0|0.26|0.89|||Proportional odds model||An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.89|0.26|0.051
71124218|NCT01264770|141754366|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.004|TWO_SIDED|90.0|0.2|0.65|||Proportional odds model||An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.65|0.20|0.004
71124219|NCT01264770|141754367|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.29|||<|0.001|TWO_SIDED|90.0|0.17|0.4||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.40|0.17|<0.001
70945275|NCT02672514|141391010|SUPERIORITY_OR_OTHER|||||||0.211|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The first blood samples were collected before cardiopulmonary bypass.||||0.211
70856932|NCT02446743|141200495|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|22.0|||||TWO_SIDED|95.0|16.5|28.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||28.6|16.5|
70945276|NCT02672514|141391010|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The blood samples were collected on arrival of intensive care unit.||||0.004
70856933|NCT02446743|141200495|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|21.0|||||TWO_SIDED|95.0|14.6|28.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||28.9|14.6|
70856934|NCT02446743|141200495|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|26.0|||||TWO_SIDED|95.0|16.4|35.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||35.3|16.4|
70856935|NCT02446743|141200495|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|68.0|||||TWO_SIDED|95.0|60.8|73.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||73.7|60.8|
70856936|NCT02446743|141200495|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|74.0|||||TWO_SIDED|95.0|65.3|81.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||81.3|65.3|
70856937|NCT02446743|141200495|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|64.0|||||TWO_SIDED|95.0|53.6|72.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||72.3|53.6|
70856938|NCT02446743|141200495|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|9.0|||||TWO_SIDED|95.0|3.7|14.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||14.0|3.7|
70856939|NCT02446743|141200495|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|7.0|||||TWO_SIDED|95.0|3.3|12.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||12.3|3.3|
70856940|NCT02446743|141200495|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|13.0|||||TWO_SIDED|95.0|4.5|22.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||22.0|4.5|
70945277|NCT02672514|141391010|SUPERIORITY_OR_OTHER|||||||0.221|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The blood samples were collected 24 hours after operation.||||0.221
70856941|NCT02446743|141200495|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|5.0|||||TWO_SIDED|95.0|-3.4|12.8|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||12.8|-3.4|
70856942|NCT02446743|141200495|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|9.0|||||TWO_SIDED|95.0|-3.3|21.4|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||21.4|-3.3|
70945278|NCT02672514|141391010|SUPERIORITY_OR_OTHER|||||||0.796|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The blood samples were collected 48 hours after operation.||||0.796
70945279|NCT02672514|141391010|SUPERIORITY_OR_OTHER|||||||0.463|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The blood samples were collected 72 hours after operation.||||0.463
70856943|NCT02446743|141200495|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|4.0|||||TWO_SIDED|95.0|-6.4|14.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||14.5|-6.4|
70945280|NCT02672514|141391010|SUPERIORITY_OR_OTHER|||||||0.118|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The first blood samples were collected before cardiopulmonary bypass.||||0.118
71124220|NCT01264770|141754367|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.3|||<|0.001|TWO_SIDED|90.0|0.18|0.43||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.43|0.18|<0.001
71124221|NCT01264770|141754367|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.19||||0.007|TWO_SIDED|90.0|0.07|0.31||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.31|0.07|0.007
71124222|NCT01264770|141754367|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.16||||0.049|TWO_SIDED|90.0|-0.3|-0.03||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.03|-0.30|0.049
71124223|NCT01264770|141754367|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.02||||0.803|TWO_SIDED|90.0|-0.16|0.12||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.12|-0.16|0.803
71124224|NCT01264770|141754367|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.24||||0.003|TWO_SIDED|90.0|-0.37|-0.1||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.10|-0.37|0.003
71124225|NCT01264770|141754368|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.09||||0.059|TWO_SIDED|90.0|0.01|0.18||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.18|0.01|0.059
71124226|NCT01264770|141754368|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.09||||0.071|TWO_SIDED|90.0|0.01|0.17||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.17|0.01|0.071
71124227|NCT01264770|141754368|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.01||||0.758|TWO_SIDED|90.0|-0.05|0.07||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.07|-0.05|0.758
71124228|NCT01264770|141754368|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.12||||0.114|TWO_SIDED|90.0|-0.24|0.0||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.00|-0.24|0.114
71124229|NCT01264770|141754368|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.14||||0.078|TWO_SIDED|90.0|-0.26|-0.01||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.01|-0.26|0.078
70856944|NCT02446743|141200496|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|15.0|||||TWO_SIDED|95.0|10.1|20.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||20.9|10.1|
70856945|NCT02446743|141200496|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|12.0|||||TWO_SIDED|95.0|7.5|18.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||18.1|7.5|
71124230|NCT01264770|141754368|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.21||||0.003|TWO_SIDED|90.0|-0.32|-0.09||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.09|-0.32|0.003
71124231|NCT01264770|141754369|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.02||||0.46|TWO_SIDED|90.0|-0.07|0.03||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.03|-0.07|0.460
71124232|NCT01264770|141754369|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.0||||0.903|TWO_SIDED|90.0|-0.05|0.06||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.06|-0.05|0.903
71124233|NCT01264770|141754369|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.03||||0.172|TWO_SIDED|90.0|-0.08|0.01||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.01|-0.08|0.172
71124234|NCT01264770|141754369|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.11||||0.082|TWO_SIDED|90.0|-0.21|-0.01||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.01|-0.21|0.082
71124235|NCT01264770|141754369|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.11||||0.092|TWO_SIDED|90.0|-0.21|0.0||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.00|-0.21|0.092
71124236|NCT01264770|141754369|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.17||||0.002|TWO_SIDED|90.0|-0.27|-0.08||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.08|-0.27|0.002
71124237|NCT01264770|141754370|SUPERIORITY_OR_OTHER||Treatment difference|23.39|||<|0.001|TWO_SIDED|90.0|9.57|40.0|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||40.00|9.57|<0.001
71124238|NCT01264770|141754370|SUPERIORITY_OR_OTHER||Treatment difference|22.97||||0.006|TWO_SIDED|90.0|7.84|38.34|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||38.34|7.84|0.006
71124239|NCT01264770|141754370|SUPERIORITY_OR_OTHER||Treatment difference|5.72||||0.234|TWO_SIDED|90.0|-3.2|21.68|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||21.68|-3.20|0.234
71124240|NCT01264770|141754371|SUPERIORITY_OR_OTHER||Treatment difference|-13.72||||0.03|TWO_SIDED|90.0|-25.01|0.0|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.00|-25.01|0.030
70856946|NCT02446743|141200496|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|21.0|||||TWO_SIDED|95.0|12.3|29.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||29.9|12.3|
70856947|NCT02446743|141200496|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|66.0|||||TWO_SIDED|95.0|59.6|72.4|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||72.4|59.6|
71086537|NCT00549549|141678556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0317|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.0317
71086538|NCT00549549|141678556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1592|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.1592
70945281|NCT02672514|141391010|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The blood samples were collected on arrival of intensive care unit.||||0.0001
70856948|NCT02446743|141200496|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|70.0|||||TWO_SIDED|95.0|60.8|77.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||77.0|60.8|
70945282|NCT02672514|141391010|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The blood samples were collected one hour after cardiopulmonary bypass.||||0.0001
70945283|NCT02672514|141391010|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The blood samples were collected four hours after cardiopulmonary bypass.||||0.0001
70945284|NCT02672514|141391010|SUPERIORITY_OR_OTHER|||||||0.171|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The blood samples were collected 48 hours after cardiopulmonary bypass.||||0.171
70856949|NCT02446743|141200496|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|65.0|||||TWO_SIDED|95.0|55.2|73.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||73.7|55.2|
70945285|NCT02154347|141391016|SUPERIORITY||Mean Difference (Final Values)|-0.66|||<|0.001|TWO_SIDED|95.0|-0.95|-0.37|||t-test, 2 sided|||||-0.37|-0.95|<0.001
70856950|NCT02446743|141200496|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|9.0|||||TWO_SIDED|95.0|4.9|13.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||13.6|4.9|
70945286|NCT00702650|141391127|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||One-Sample Binomial (Wald) test, 2-sided|||||||<0.001
70945287|NCT00702650|141391132|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value is for Sexual Desire based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.|t-test, 2 sided|||||||<0.0001
70945288|NCT00702650|141391132|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value is for Overall Sexual Activity Score based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.|t-test, 2 sided|||||||<0.0001
70945289|NCT00702650|141391132|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value is for Erection Maintained for Satisfactory Duration based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.|t-test, 2 sided|||||||<0.0001
70945290|NCT00702650|141391132|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value is for Positive Mood based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.|t-test, 2 sided|||||||<0.0001
70945291|NCT00702650|141391132|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value is for Negative Mood based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.|t-test, 2 sided|||||||<0.0001
70945292|NCT00702650|141391133|SUPERIORITY_OR_OTHER|||||||0.0254||95.0||||p-value for Physical Component Score based on a one-sample t-test comparing Day 120 and Baseline values.|t-test, 2 sided|||||||0.0254
70945293|NCT00702650|141391133|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value for Mental Component Score based on a one-sample t-test comparing Day 120 and Baseline values.|t-test, 2 sided|||||||<0.0001
70945294|NCT01475461|141391150|SUPERIORITY_OR_OTHER||Least squares (LS) Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.172||0.5206|TWO_SIDED|80.0|-0.21|0.23||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Week 12: Treatment difference and 80 percent(%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||0.23|-0.21|0.5206
70945295|NCT01475461|141391150|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.178||0.1645|TWO_SIDED|80.0|-0.4|0.05||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo||0.05|-0.40|0.1645
71086539|NCT00549549|141678556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7956|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.7956
71086540|NCT00549549|141678557|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.17|0.31|||ANCOVA|||The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.||0.31|-0.17|
71086541|NCT00549549|141678557|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.02|0.46|||ANCOVA|||||0.46|-0.02|
71086542|NCT00549549|141678557|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.5|-0.02|||ANCOVA|||||-0.02|-0.50|
71086543|NCT00549549|141678557|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.43|0.05|||ANCOVA|||||0.05|-0.43|
71086544|NCT00549549|141678557|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.28|0.19|||ANCOVA|||||0.19|-0.28|
71086545|NCT00549549|141678558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED||||||Cochran-Mantel-Haenszel|||p-value calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1; \>1\], and region.||||0.3173
71086546|NCT00549549|141678559|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4724|TWO_SIDED||||||Cochran-Mantel-Haenszel|||p-value calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1; \>1\], and region.||||0.4724
71086547|NCT00549549|141678559|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7316|TWO_SIDED||||||Cochran-Mantel-Haenszel|||p-value calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1; \>1\], and region.||||0.7316
71086548|NCT00549549|141678559|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7316|TWO_SIDED||||||Cochran-Mantel-Haenszel|||p-value calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1; \>1\], and region.||||0.7316
71086549|NCT00248651|141678571|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANCOVA|||Overall treatment effect from logistic regression model incorporating balancing factors. A p-value of \<0.05 was considered statistically significant.||||0.05
71086550|NCT00248651|141678574|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANCOVA|||Comparison between antidepressant arms and placebo for overall quality of life. A p-value of \<0.05 was considered statistically significant.||||0.02
71086551|NCT00248651|141678574|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANCOVA|||Comparison between antidepressant arms and placebo for Eat/Drink subscale. A p-value of \<0.05 was considered statistically significant.||||0.06
70945296|NCT01475461|141391150|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.172||0.1592|TWO_SIDED|80.0|-0.39|0.05||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||0.05|-0.39|0.1592
70856951|NCT02446743|141200496|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|5.0|||||TWO_SIDED|95.0|1.2|9.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||9.7|1.2|
70856952|NCT02446743|141200496|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|15.0|||||TWO_SIDED|95.0|7.5|22.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||22.6|7.5|
70945297|NCT01475461|141391150|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.174||0.0049|TWO_SIDED|80.0|-0.68|-0.23||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||-0.23|-0.68|0.0049
70945298|NCT01475461|141391150|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.173||0.0068|TWO_SIDED|80.0|-0.65|-0.21||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||-0.21|-0.65|0.0068
71086552|NCT00248651|141678574|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANCOVA|||Comparison between antidepressant arms and placebo for Interference subscale. A p-value of \<0.05 was considered statistically significant.||||0.06
71086553|NCT00248651|141678574|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANCOVA|||Comparison between antidepressant arms and placebo for Sleep Disturbance subscale. A p-value of \<0.05 was considered statistically significant.||||0.01
71086554|NCT00248651|141678574|SUPERIORITY_OR_OTHER|||||||0.04|||||||ANCOVA|||Comparison between antidepressant arms and placebo for Work/Study subscale. A p-value of \<0.05 was considered statistically significant.||||0.04
71086555|NCT02688933|141678575|SUPERIORITY||Least Square mean difference|0.22|STANDARD_ERROR_OF_MEAN|1.15||0.8494|TWO_SIDED|||||Threshold for significance at 0.05 level.|Generalized linear model|Generalized linear model with identity link||Analysis was performed using generalized linear model with identity link, had percentage of time glucose concentration within target range 70-180 mg/dL as dependent variable, treatment group as an independent variable, adjusting variables including baseline characteristics: duration of diabetes, baseline BMI, age, and randomization strata (HbA1c at screening \[\<8.0% vs ≥8.0%\], frequency of Lantus injection at screening, current CGM use \[yes/no\], and mealtime insulin titration algorithm).||||0.8494
71086556|NCT01275144|141678583|SUPERIORITY_OR_OTHER||Ratio of geometric least square mean|0.897|||||TWO_SIDED|90.0|0.86|0.94|||||Ratio of LY2216684 to Placebo|||0.94|0.86|
71086557|NCT01275144|141678584|SUPERIORITY_OR_OTHER||median of paired differences|0.5||||0.0021|TWO_SIDED|90.0|0.5|1.0|||Wilcoxon signed rank test||Ratio of LY2216684 to Placebo|||1.00|0.50|0.0021
71086558|NCT01275144|141678585|SUPERIORITY_OR_OTHER||Ratio of geometric least square mean|1.04|||||TWO_SIDED|90.0|1.01|1.08|||||Ratio of LY2216684 to Placebo|||1.08|1.01|
71086559|NCT04622969|141678615|SUPERIORITY||Mean Difference (Net)|-21.6|STANDARD_ERROR_OF_MEAN|5.157|<|0.001|TWO_SIDED||||||ANCOVA|||||||<.001
71086560|NCT04622969|141678617|SUPERIORITY||Mean Difference (Net)|7.12|STANDARD_ERROR_OF_MEAN|12.05|=|0.56|TWO_SIDED||||||Mixed Models Analysis|||||||=0.56
71086561|NCT04622969|141678621|SUPERIORITY||Mean Difference (Net)|0.0015|STANDARD_ERROR_OF_MEAN|0.145|=|0.99|TWO_SIDED||||||Mixed Models Analysis|||||||=0.99
71086562|NCT04622969|141678623|SUPERIORITY||Mean Difference (Net)|-0.264|STANDARD_ERROR_OF_MEAN|0.121|<|0.05|TWO_SIDED||||||ANCOVA|||||||<.05
71086563|NCT04622969|141678625|SUPERIORITY||Mean Difference (Net)|-5.573|STANDARD_ERROR_OF_MEAN|1.802|<|0.01|TWO_SIDED||||||ANCOVA|||||||<.01
71086564|NCT04622969|141678627|SUPERIORITY||Mean Difference (Net)|3.509|STANDARD_ERROR_OF_MEAN|1.842|=|0.062|TWO_SIDED||||||ANCOVA|||||||=.062
71086565|NCT04622969|141678627|SUPERIORITY||Mean Difference (Net)|0.047|STANDARD_ERROR_OF_MEAN|0.17|=|0.78|TWO_SIDED||||||Mixed Models Analysis|||||||=0.78
71086566|NCT05607576|141678628|OTHER|Clarke error grid analyses (EGA) were performed to compare CGM values to glucometer glucose values blood glucose readings (mg/dL) were grouped based on radiation exposure (\>0-500 µGy and \>500 µGy). A p-value \<0.05 was considered statistically significant.|||||<|0.05|||||||Mixed Models Analysis|Generalized linear mixed models with random effects were used to assess absolute differences in BG mg/dL by cumulative scatter||||||<0.05
71086567|NCT05607576|141678629|OTHER|Clarke error grid analyses (EGA) were performed to compare CGM values to glucometer glucose values. A p-value \<0.05 was considered statistically significant.|||||<|0.05|||||||Mixed Models Analysis|Generalized linear mixed models with random effects over time were used to assess absolute differences in BG mg/dL by time||||||<0.05
71086568|NCT04391842|141678645|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71086569|NCT04391842|141678646|OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71086570|NCT00810199|141678647|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.2055|TWO_SIDED|95.0|0.882|1.799||Cochran-Mantel-Haenszel test stratified by region and baseline DAS28 (≤5.5 and \>5.5).|Cochran-Mantel-Haenszel|||||1.799|0.882|0.2055
71086571|NCT00810199|141678647|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.1894|TWO_SIDED|95.0|0.889|1.814||Logistic regression including treatment , region and baseline DAS28.|Regression, Logistic|Odds ratio is for Tocilizumab + Methotrexate relative to Tocilizumab + Placebo.||||1.814|0.889|0.1894
71086572|NCT00810199|141678648|SUPERIORITY_OR_OTHER|||||||0.8742||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 24||||0.8742
70945299|NCT01475461|141391151|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.097||0.3434|TWO_SIDED|80.0|-0.16|0.09||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80 percent(%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.09|-0.16|0.3434
71086573|NCT00810199|141678648|SUPERIORITY_OR_OTHER|||||||0.6212||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 52||||0.6212
71086574|NCT00810199|141678648|SUPERIORITY_OR_OTHER|||||||0.0963||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 104||||0.0963
70945300|NCT01475461|141391151|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.101||0.0892|TWO_SIDED|80.0|-0.27|-0.01||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, as the covariates, time was repeated for participant.||-0.01|-0.27|0.0892
71086575|NCT00810199|141678649|SUPERIORITY_OR_OTHER|||||||0.2969||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 24||||0.2969
71086576|NCT00810199|141678649|SUPERIORITY_OR_OTHER|||||||0.2215||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 52||||0.2215
71086577|NCT00810199|141678649|SUPERIORITY_OR_OTHER|||||||0.1243||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 104||||0.1243
71124241|NCT01264770|141754371|SUPERIORITY_OR_OTHER||Treatment difference|-9.49||||0.207|TWO_SIDED|90.0|-25.0|6.96|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||6.96|-25.00|0.207
71124242|NCT01264770|141754371|SUPERIORITY_OR_OTHER||Treatment difference|-19.53||||0.002|TWO_SIDED|90.0|-30.01|-6.25|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-6.25|-30.01|0.002
71124243|NCT01264770|141754372|SUPERIORITY_OR_OTHER||Treatment difference|0.24||||0.007|TWO_SIDED|90.0|0.09|0.38|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.38|0.09|0.007
71124244|NCT01264770|141754372|SUPERIORITY_OR_OTHER||Treatment difference|0.22||||0.016|TWO_SIDED|90.0|0.07|0.37|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.37|0.07|0.016
71124245|NCT01264770|141754372|SUPERIORITY_OR_OTHER||Treatment difference|0.14||||0.094|TWO_SIDED|90.0|0.0|0.29|||ANCOVA|Includes terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.29|0.00|0.094
71124246|NCT01264770|141754373|SUPERIORITY_OR_OTHER||Treatment difference|-0.2||||0.043|TWO_SIDED|90.0|-0.36|-0.04|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.04|-0.36|0.043
71124247|NCT01264770|141754373|SUPERIORITY_OR_OTHER||Treatment difference|-0.14||||0.158|TWO_SIDED|90.0|-0.31|0.02|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.02|-0.31|0.158
71124248|NCT01264770|141754373|SUPERIORITY_OR_OTHER||Treatment difference|-0.32||||0.001|TWO_SIDED|90.0|-0.47|-0.16|||ANCOVA|Includes terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.16|-0.47|0.001
71124249|NCT01264770|141754374|SUPERIORITY_OR_OTHER||Treatment difference|-2.77||||0.05|TWO_SIDED|90.0|-5.08|-0.45|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.45|-5.08|0.050
71086578|NCT00810199|141678650|SUPERIORITY_OR_OTHER|||||||0.6775||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 24||||0.6775
71086579|NCT00810199|141678650|SUPERIORITY_OR_OTHER|||||||0.9976||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 52||||0.9976
71086580|NCT00810199|141678650|SUPERIORITY_OR_OTHER|||||||0.2168||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 104||||0.2168
71086581|NCT00810199|141678651|SUPERIORITY_OR_OTHER|||||||0.8369||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 24||||0.8369
71086582|NCT00810199|141678651|SUPERIORITY_OR_OTHER|||||||0.6528||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 52||||0.6528
71086583|NCT00810199|141678651|SUPERIORITY_OR_OTHER|||||||0.2546||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 104||||0.2546
71086584|NCT00810199|141678652|SUPERIORITY_OR_OTHER|||||||0.1018|||||||Log Rank|||||||0.1018
71086585|NCT00810199|141678653|SUPERIORITY_OR_OTHER|||||||0.7176|||||||Log Rank|||||||0.7176
71086586|NCT00810199|141678654|SUPERIORITY_OR_OTHER|||||||0.8526|||||||Log Rank|||||||0.8526
71086587|NCT00810199|141678655|SUPERIORITY_OR_OTHER|||||||0.2217|||||||Log Rank|||||||0.2217
71086588|NCT00810199|141678656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.0008|TWO_SIDED|95.0|-0.41|-0.11|||ANCOVA|Baseline DAS28 as a covariate.||||-0.11|-0.41|0.0008
71086589|NCT00810199|141678657|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.0245|TWO_SIDED|95.0|1.053|2.109|||Regression, Logistic|Logistic regression including treatment, region and baseline DAS28.|Odds ratio is for Tocilizumab + Methotrexate relative to Tocilizumab + Placebo.|||2.109|1.053|0.0245
71086590|NCT00810199|141678657|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.482||||0.0258||95.0|1.048|2.095||Stratified by region and baseline DAS28 (≤ 5.5 and \> 5.5).|Cochran-Mantel-Haenszel|||||2.095|1.048|0.0258
71086591|NCT00810199|141678658|SUPERIORITY_OR_OTHER|||||||0.0287||95.0|||||Wald Chi-square|Asymptotic test; parameter estimate is zero.||Week 24||||0.0287
71086592|NCT00810199|141678658|SUPERIORITY_OR_OTHER|||||||0.224|||||||Wald Chi-square|Asymptotic test; parameter estimate is zero.||Week 52||||0.2240
71086593|NCT00810199|141678659|SUPERIORITY_OR_OTHER|||||||0.0497||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.0497
71086594|NCT00810199|141678659|SUPERIORITY_OR_OTHER|||||||0.3918|||||||Wilcoxon (Mann-Whitney)|||Week 52||||0.3918
71086595|NCT00810199|141678660|SUPERIORITY_OR_OTHER|||||||0.0019||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 24||||0.0019
71086596|NCT00810199|141678660|SUPERIORITY_OR_OTHER|||||||0.1181|||||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 52||||0.1181
71086597|NCT00810199|141678661|SUPERIORITY_OR_OTHER|||||||0.7776||||||P-value is from a 2-sided, Wilcoxon rank-sum test of no difference between the 2 treatment groups in change from baseline.|Wilcoxon (Mann-Whitney)|||Week 24||||0.7776
71086598|NCT00810199|141678661|SUPERIORITY_OR_OTHER|||||||0.8843|||||||Wilcoxon (Mann-Whitney)|||Week 52||||0.8843
71086599|NCT00810199|141678662|SUPERIORITY_OR_OTHER|||||||0.9095||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.9095
71086600|NCT00810199|141678662|SUPERIORITY_OR_OTHER|||||||0.7179|||||||Wilcoxon (Mann-Whitney)|||Week 52||||0.7179
71086601|NCT00810199|141678663|SUPERIORITY_OR_OTHER|||||||0.3113||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.3113
71086602|NCT00810199|141678663|SUPERIORITY_OR_OTHER|||||||0.2931||95.0|||||Wilcoxon (Mann-Whitney)|||Week 52||||0.2931
71086603|NCT00810199|141678664|SUPERIORITY_OR_OTHER|||||||0.2451||95.0||||P-value is from a 2-sided, Wilcoxon rank-sum test of no difference between the 2 treatment groups in change from baseline.|Wilcoxon (Mann-Whitney)|||Week 24||||0.2451
71086604|NCT00810199|141678664|SUPERIORITY_OR_OTHER|||||||0.8841||95.0|||||Wilcoxon (Mann-Whitney)|||Week 52||||0.8841
71086605|NCT00810199|141678665|SUPERIORITY_OR_OTHER|||||||0.9655||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.9655
71086606|NCT00810199|141678665|SUPERIORITY_OR_OTHER|||||||0.0308||95.0|||||Wilcoxon (Mann-Whitney)|||Week 52||||0.0308
71086607|NCT00810199|141678666|SUPERIORITY_OR_OTHER|||||||0.5186||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.5186
71086608|NCT00810199|141678666|SUPERIORITY_OR_OTHER|||||||0.7706||95.0|||||Wilcoxon (Mann-Whitney)|||Week 52||||0.7706
71086609|NCT00810199|141678667|SUPERIORITY_OR_OTHER|||||||0.6067||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.6067
71086610|NCT00810199|141678667|SUPERIORITY_OR_OTHER|||||||0.681||95.0|||||Wilcoxon (Mann-Whitney)|||Week 52||||0.6810
71086611|NCT00810199|141678668|SUPERIORITY_OR_OTHER|||||||0.9323||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.9323
71086612|NCT00810199|141678668|SUPERIORITY_OR_OTHER|||||||0.1448||95.0|||||Wilcoxon (Mann-Whitney)|||Week 52||||0.1448
71086613|NCT00810199|141678669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.2034|TWO_SIDED|95.0|-0.43|0.09||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 24||0.09|-0.43|0.2034
71086614|NCT00810199|141678669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.3611|TWO_SIDED|95.0|-0.88|0.32||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 52||0.32|-0.88|0.3611
71086615|NCT00810199|141678669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.0342|TWO_SIDED|95.0|-1.16|-0.05||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 104||-0.05|-1.16|0.0342
71086616|NCT00810199|141678670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.7095|TWO_SIDED|95.0|-0.23|0.16||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 24||0.16|-0.23|0.7095
71086617|NCT00810199|141678670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.8147|TWO_SIDED|95.0|-0.45|0.57||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 52||0.57|-0.45|0.8147
71086618|NCT00810199|141678670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.0778|TWO_SIDED|95.0|-0.67|0.04||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 104||0.04|-0.67|0.0778
71086619|NCT00810199|141678671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.0441|TWO_SIDED|95.0|-0.25|0.0||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 24||-0.00|-0.25|0.0441
71086620|NCT00810199|141678671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.0012|TWO_SIDED|95.0|-0.54|-0.13||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 52||-0.13|-0.54|0.0012
71086621|NCT00810199|141678671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.0372|TWO_SIDED|95.0|-0.56|-0.02||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 104||-0.02|-0.56|0.0372
71086622|NCT00810199|141678672|SUPERIORITY_OR_OTHER||Difference|6.75||||0.0694|TWO_SIDED|95.0|-1.02|14.52|||Cochran-Mantel-Haenszel|Stratified by region and categorical baseline DAS28 (≤ 5.5 and \> 5.5).||Week 52||14.52|-1.02|0.0694
71086623|NCT00810199|141678672|SUPERIORITY_OR_OTHER|||||||0.1695|TWO_SIDED||||||Log Rank|||Week 104||||0.1695
71086624|NCT00810199|141678673|SUPERIORITY_OR_OTHER||Difference|-2.91||||0.0496||95.0|-5.86|0.05|||Cochran-Mantel-Haenszel|Stratified by region and categorical baseline DAS28 (≤ 5.5 and \> 5.5).||||0.05|-5.86|0.0496
71086625|NCT00810199|141678674|SUPERIORITY_OR_OTHER||Difference|-1.48||||0.5188|TWO_SIDED|95.0|-6.59|3.62|||Cochran-Mantel-Haenszel|Stratified by region and categorical baseline DAS28 (≤ 5.5 and \> 5.5).||||3.62|-6.59|0.5188
70856953|NCT02446743|141200496|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|2.0|||||TWO_SIDED|95.0|-6.8|10.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||10.0|-6.8|
71086626|NCT00810199|141678675|SUPERIORITY_OR_OTHER|||||||0.2652|||||||Wilcoxon (Mann-Whitney)|||Week 24||||0.2652
71086627|NCT00810199|141678675|SUPERIORITY_OR_OTHER|||||||0.197|||||||Wilcoxon (Mann-Whitney)|||Week 52||||0.1970
71086628|NCT00810199|141678675|SUPERIORITY_OR_OTHER|||||||0.1671|||||||Wilcoxon (Mann-Whitney)|||||||0.1671
71086629|NCT00810199|141678677|SUPERIORITY_OR_OTHER||Adjusted Mean Difference (Wald CI)|5.22||||0.111|TWO_SIDED|95.0|-1.2|11.64|||ANCOVA|The analysis of covariance model included treatment group, region and baseline DAS28 (≤ 5.5 and \> 5.5) as fixed factors.||||11.64|-1.20|0.1110
71086630|NCT00810199|141678678|SUPERIORITY_OR_OTHER||Adjusted Mean Difference (Wald CI)|-2.11||||0.6027|TWO_SIDED|95.0|-10.07|5.85|||ANCOVA|The analysis of covariance model included treatment group, region and baseline DAS28 (≤ 5.5 and \> 5.5) as fixed factors.||||5.85|-10.07|0.6027
71124250|NCT01264770|141754374|SUPERIORITY_OR_OTHER||Treatment difference|-1.33||||0.36|TWO_SIDED|90.0|-3.73|1.06|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||1.06|-3.73|0.360
71124251|NCT01264770|141754374|SUPERIORITY_OR_OTHER||Treatment difference|-2.99||||0.032|TWO_SIDED|90.0|-5.29|-0.7|||ANCOVA|Includes terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.70|-5.29|0.032
71124252|NCT01264770|141754375|SUPERIORITY_OR_OTHER||Treatment difference|-1.02||||0.568|TWO_SIDED|90.0|-3.95|1.92|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||1.92|-3.95|0.568
70856954|NCT02446743|141200496|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|3.0|||||TWO_SIDED|95.0|-9.8|15.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||15.2|-9.8|
71086631|NCT00810199|141678679|SUPERIORITY_OR_OTHER|||||||0.1695|||||||Log Rank|||||||0.1695
71086632|NCT00810199|141678680|SUPERIORITY_OR_OTHER|||||||0.0096|||||||Log Rank|||||||0.0096
71086633|NCT00810199|141678681|SUPERIORITY_OR_OTHER|||||||0.0734|||||||Log Rank|||||||0.0734
71086634|NCT02175225|141678701|OTHER|The alternative hypothesis, reflecting futility, is that the absolute treatment effect is less than 12% in favor of deferoxamine. In accordance with the futility design, futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if the upper bound on the risk difference was less than 12% in favour of deferoxamine mesylate, this would be considered evidence of futility.|Risk Difference (RD)|0.006|||||ONE_SIDED|90.0||0.068|||||Futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if UCB was less than 12% in favour of deferoxamine mesylate, this is considered evidence of futility.|||0.068||
71086635|NCT02175225|141678702|OTHER||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.57|1.16||||||||1.16|0.57|
71124253|NCT01264770|141754375|SUPERIORITY_OR_OTHER||Treatment difference|-1.66||||0.368|TWO_SIDED|90.0|-4.69|1.38|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||1.38|-4.69|0.368
71086636|NCT02175225|141678703|OTHER||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.57|1.56||||||||1.56|0.57|
71086637|NCT02175225|141678704|OTHER|The alternative hypothesis, reflecting futility, is that the absolute treatment effect is less than 13% in favor of deferoxamine. In accordance with the futility design, futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if the upper bound on the risk difference was less than13% in favor of deferoxamine mesylate, this would be considered evidence of futility.|Risk Difference (RD)|0.062|||||ONE_SIDED|90.0||0.121|||||Futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference\[AARD\]); if UCB was less than 12% in favour of deferoxamine mesylate, this is considered evidence of futility.|||0.121||
70945301|NCT01475461|141391151|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.097||0.0826|TWO_SIDED|80.0|-0.26|-0.01||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, as the covariates, time was repeated for participant.||-0.01|-0.26|0.0826
71086638|NCT02175225|141678705|OTHER|The alternative hypothesis, reflecting futility, is that the absolute treatment effect is less than 12% in favor of deferoxamine. In accordance with the futility design, futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if the upper bound on the risk difference was less than 12% in favour of deferoxamine mesylate, this would be considered evidence of futility.|Risk Difference (RD)|0.086|||||ONE_SIDED|90.0||0.156|||||Futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if UCB was less than 12% in favour of deferoxamine mesylate, this is considered evidence of futility.|||0.156||
71086639|NCT02175225|141678706|OTHER|The alternative hypothesis, reflecting futility, is that the absolute treatment effect is less than 13% in favor of deferoxamine. In accordance with the futility design, futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if the upper bound on the risk difference was less than 13% in favour of deferoxamine mesylate, this would be considered evidence of futility.|Risk Difference (RD)|-0.018|||||ONE_SIDED|90.0||0.029|||||Futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if UCB was less than 13% in favour of deferoxamine mesylate, this is considered evidence of futility.|||0.029||
71086640|NCT02175225|141678707|OTHER|||||||0.83||||||The p value reflects the significance of the interaction term between treatment and onset to treatment time.|Regression, Logistic|||||||0.83
71124254|NCT01264770|141754375|SUPERIORITY_OR_OTHER||Treatment difference|-2.48||||0.16|TWO_SIDED|90.0|-5.38|0.43|||ANCOVA|Includes terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.43|-5.38|0.160
71124255|NCT00424190|141754379|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% confidence interval (CI) for the observed difference in the primary outcome measure between ceftaroline and vancomycin plus aztreonam was calculated. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10%.|Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-4.2|6.2|||||Risk difference corresponds to Ceftaroline clinical cure rate minus Vancomycin plus Aztreonam clinical cure rate. The confidence interval was calculated using the Miettinen and Nurminen method without adjustment.|The primary objective of this study was to determine the noninferiority in clinical cure rate of ceftaroline in comparison with vancomycin plus aztreonam in adult subjects with cSSSI.||6.2|-4.2|
70856955|NCT02446743|141200496|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|4.0|||||TWO_SIDED|95.0|-7.8|14.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||14.7|-7.8|
71086641|NCT02175225|141678708|OTHER||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.72|1.67|||||The estimation parameter is the adjusted common odds ratio.|||1.67|0.72|
71086642|NCT02175225|141678709|OTHER||Odds Ratio, log|1.26|||||TWO_SIDED|95.0|0.82|1.93||||||||1.93|0.82|
71086643|NCT02175225|141678712|OTHER||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.0|14.97|||||Confidence interval is exact (rather than asymptotic) due to small number of events.|||14.97|0.0|
70856956|NCT02446743|141200497|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group ratio of GMTs|2.54|||||TWO_SIDED|95.0|2.07|3.12|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||3.12|2.07|
71086644|NCT02175225|141678713|OTHER||Risk Ratio (RR)|0.89|||||TWO_SIDED|95.0|0.51|1.54|||||Confidence interval constructed only for all cause owing to small number of events caused by acute respiratory distress syndrome.|||1.54|0.51|
71086645|NCT02175225|141678714|OTHER||Risk Ratio (RR)|1.84|||||TWO_SIDED|95.0|0.63|5.35||||||||5.35|0.63|
71086646|NCT04152200|141678761|OTHER|Not applied|Least Squares (LS) Mean|-33.33|STANDARD_ERROR_OF_MEAN|17.63|||TWO_SIDED|95.0|-81.82|15.16|||Mixed model repeated measures (MMRM)|||Restricted maximum likelihood (REML) based Mixed Model Repeated Measures (MMRM) was used to test against the null hypothesis of mean change from baseline outcome being equal to 0. The model includes scheduled visits and baseline plasma oxalate (μmol/L) as fixed effects and patient as a random factor. Autoregressive (1) was used to model the within-patient variability.||15.16|-81.82|
71086647|NCT04152200|141678762|OTHER|Not applied|Least Squares (LS) Mean|-42.43|STANDARD_ERROR_OF_MEAN|3.95|||TWO_SIDED|95.0|-50.71|-34.15|||MMRM|||REML based Mixed Model Repeated Measures MMRM was used to test against the null hypothesis of mean change from baseline outcome being equal to 0. The model includes scheduled visits and baseline plasma oxalate (μmol/L) as fixed effects and patient as a random factor. Autoregressive (1) was used to model the within-patient variability.||-34.15|-50.71|
71086648|NCT00593814|141678809|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71124256|NCT00351273|141754387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.8||||0.01|TWO_SIDED||||||Fisher Exact|||Difference in the percentages of participants with response between all those who received combination therapy vs. placebo||||0.01
71124257|NCT01672866|141754395|SUPERIORITY||Difference in LSMeans [SIM - Placebo]|-0.2|||||TWO_SIDED|95.0|-1.3|1.0||||||A mixed-effect model for repeated measures (MMRM) with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% confidence interval (CI) for the treatment difference between each treatment arm and placebo in least squares mean (LSMean) change from baseline in MQC at Week 96. With MMRM setting, all participants with available data from 3 treatment groups with change in MQC at Week 48 and/or Week 96 contributed to the overall model.||1.0|-1.3|
71124258|NCT01672866|141754395|SUPERIORITY||Difference in LSMeans [SIM - Placebo]|-0.4|||||TWO_SIDED|95.0|-1.5|0.8||||||An MMRM with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% CI for the treatment difference between each treatment arm and placebo in LSMean change from baseline in MQC at Week 96. With MMRM setting, all participants with available data from 3 treatment groups with change in MQC at Week 48 and/or Week 96 contributed to the overall model.||0.8|-1.5|
71124259|NCT01672866|141754396|SUPERIORITY|||||||0.73|||||||Stratified log-rank test|||Differences in EFS between a given SIM group and placebo were assessed using the log-rank test stratified by the presence or absence of diabetes at baseline.||||0.73
71124260|NCT01672866|141754396|SUPERIORITY|||||||0.85|||||||Stratified log-rank test|||Differences in EFS between a given SIM group and placebo were assessed using the log-rank test stratified by the presence or absence of diabetes at baseline.||||0.85
71124261|NCT02033213|141754407|SUPERIORITY_OR_OTHER|||||||0.41||||||P \< 0.05 was considered significant.|t-test, 1 sided|||The measurement was assessed at 10 minutes time point.||||0.410
71124262|NCT02033213|141754407|SUPERIORITY_OR_OTHER|||||||0.621||||||P \< 0.05 was considered significant.|t-test, 1 sided|||The measurement was assessed at 6 hours time point.||||0.621
71124263|NCT02033213|141754408|SUPERIORITY_OR_OTHER|||||||0.791||||||P \< 0.05 was considered significant.|t-test, 1 sided|||The measurement was assessed at 10 minutes time point.||||0.791
71124264|NCT02033213|141754408|SUPERIORITY_OR_OTHER|||||||0.41||||||P \< 0.05 was considered significant.|t-test, 1 sided|||The measurement was assessed at 6 hours time point.||||0.410
71124265|NCT02033213|141754409|SUPERIORITY_OR_OTHER|||||||0.322||||||P \< 0.05 was considered significant.|t-test, 1 sided|||The measurement aws assessed at 10 minutes time point.||||0.322
71124266|NCT02033213|141754409|SUPERIORITY_OR_OTHER|||||||0.574||||||P \< 0.05 was considered significant.|t-test, 1 sided|||The measurement was assessed at 6 hours time point.||||0.574
71124267|NCT02033213|141754410|SUPERIORITY_OR_OTHER|||||||0.03||||||P \< 0.05 was considered significant.|t-test, 1 sided|||||||0.030
71124268|NCT02033213|141754410|SUPERIORITY_OR_OTHER|||||||0.096||||||P \< 0.05 was considered significant.|t-test, 1 sided|||||||0.096
71124269|NCT02033213|141754411|SUPERIORITY_OR_OTHER|||||||0.362|||||||t-test, 1 sided|||||||0.362
71124270|NCT02033213|141754412|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 1 sided|||||||0.020
71124271|NCT01073930|141754464|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the 1-sided 97.5% CI for the treatment difference (PICOPREP minus HalfLytely) was \>-9% for the percentage of responders. Superiority was demonstrated if the 1-sided 97.5% CI for treatment difference was \>0%.|Mean Difference (Net)|9.8|||||ONE_SIDED|97.5|3.4||||||||||3.4|
71124272|NCT01073930|141754465|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|10.7|||||ONE_SIDED|97.5|4.9|||||||Ascending colon comparison|||4.9|
71124273|NCT01073930|141754465|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|6.6|||||ONE_SIDED|97.5|1.6|||||||Mid colon comparison|||1.6|
71086649|NCT02699996|141678818|SUPERIORITY||Mean Difference (Final Values)|0.52|||<|0.01|TWO_SIDED|95.0|0.17|0.86|||t-test, 2 sided|df = 14||RTQ-Survivor Adolescent Responsibility Score||0.86|0.17|<.01
71086650|NCT02699996|141678818|SUPERIORITY||Mean Difference (Final Values)|0.67|||<|0.01|TWO_SIDED|95.0|0.27|1.07|||t-test, 2 sided|df=14||RTQ-Overall Readiness Score||1.07|0.27|<.01
71086651|NCT02699996|141678819|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.02|TWO_SIDED|95.0|0.05|0.42|||t-test, 2 sided|df=14||TRI-total Score||0.42|0.05|0.02
71086652|NCT02699996|141678819|SUPERIORITY||Mean Difference (Final Values)|0.49|||<|0.01|TWO_SIDED|95.0|0.26|0.73|||t-test, 2 sided|df=14||TRI Knowledge score||0.73|0.26|<.01
71086653|NCT02699996|141678819|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.053|TWO_SIDED|95.0|-0.0044|0.6|||t-test, 2 sided|df=14||TRI Skills/Self-Efficacy Score||0.60|-0.0044|0.053
71086654|NCT02699996|141678819|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.03|TWO_SIDED|95.0|0.02|0.24|||t-test, 2 sided|df=14||TRI Beliefs/Expectations score||0.24|0.02|0.03
71086655|NCT02699996|141678819|SUPERIORITY||Mean Difference (Final Values)|0.4|||<|0.01|TWO_SIDED|95.0|0.11|0.69|||t-test, 2 sided|df=14||TRI Goals/Motivation score||0.69|0.11|<.01
71086656|NCT02699996|141678819|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.61|TWO_SIDED|95.0|-0.16|0.26|||t-test, 2 sided|df=14||Relationship/Communication Score||0.26|-0.16|0.61
71086657|NCT02699996|141678819|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.65|TWO_SIDED|95.0|-0.37|0.57|||t-test, 2 sided|df=14||TRI Psychosocial/Emotional Score||0.57|-0.37|0.65
71086658|NCT02699996|141678820|SUPERIORITY||Median Difference (Final Values)|-1.64||||0.56|TWO_SIDED|95.0|-7.62|4.34|||t-test, 2 sided|df = 13||||4.34|-7.62|.56
71086659|NCT02699996|141678821|SUPERIORITY||Mean Difference (Final Values)|-1.74||||0.42|TWO_SIDED|95.0|-6.23|2.75|||t-test, 2 sided|df = 14||||2.75|-6.23|.42
71086660|NCT02699996|141678822|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.26|TWO_SIDED|95.0|-0.8|0.23|||t-test, 2 sided|df = 14||||0.23|-0.80|.26
71124274|NCT01073930|141754465|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|5.2|||||ONE_SIDED|97.5|0.4|||||||Recto-sigmoid colon comparison|||0.4|
71086661|NCT02699996|141678823|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.03|TWO_SIDED|95.0|0.03|0.52|||t-test, 2 sided|df = 14||||0.52|0.03|.03
71086662|NCT02699996|141678824|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.2|TWO_SIDED|95.0|-0.12|0.52|||t-test, 2 sided|df = 14||Body Health Subscale||0.52|-0.12|.20
71086663|NCT02699996|141678824|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.4|TWO_SIDED|95.0|-0.46|0.2|||t-test, 2 sided|df = 14||Personal Growth Subscale||0.20|-0.46|.40
71086664|NCT02699996|141678824|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.29|TWO_SIDED|95.0|-0.09|0.29|||t-test, 2 sided|df = 14||Memory Subscale||0.29|-0.09|.29
71086665|NCT02699996|141678825|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.08|TWO_SIDED|95.0|-0.4|0.03|||t-test, 2 sided|df = 14||||0.03|-0.40|.08
71086666|NCT01095835|141678831|SUPERIORITY_OR_OTHER|||||||0.08|||||||Chi-squared|||||||0.08
71086667|NCT04006145|141678894|SUPERIORITY||LS-Means Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.184||0.029|TWO_SIDED|95.0|-0.76|-0.04|||ANCOVA|||Change from baseline in serum LDL-C at Week 16 was analyzed using ANCOVA after the missing data imputation, with treatment group as a factor, baseline serum LDL-C, baseline LDL-C-by-treatment interaction values, and baseline lipid-lowering medications (Yes or No) as covariates. Missing data for serum LDL-C was imputed through multiple imputation method as described in the statistical analysis plan (SAP).||-0.04|-0.76|0.029
71086668|NCT01249417|141678907|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-0.38||||0.0029|TWO_SIDED|95.0|-0.64|-0.13|||ANCOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, age range at baseline, BTX status at baseline and centre as covariates.||-0.13|-0.64|0.0029
71086669|NCT01249417|141678907|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-0.49||||0.0002|TWO_SIDED|95.0|-0.75|-0.23|||ANCOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, age range at baseline, BTX status at baseline and centre as covariates.||-0.23|-0.75|0.0002
71086670|NCT01249417|141678908|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|0.82|||<|0.0001|TWO_SIDED|95.0|0.5|1.14|||ANOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANOVA on the visit value with treatment, age range at baseline, BTX status at baseline and centre as covariates.||1.14|0.50|<0.0001
71086671|NCT01249417|141678908|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|0.77|||<|0.0001|TWO_SIDED|95.0|0.45|1.1|||ANOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANOVA on the visit value with treatment, age range at baseline, BTX status at baseline and centre as covariates.||1.10|0.45|<0.0001
71086672|NCT01249417|141678909|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|5.32||||0.0006|TWO_SIDED|95.0|2.31|8.32|||ANOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANOVA on the visit value with treatment, age range at baseline, BTX status at baseline and centre as covariates.||8.32|2.31|0.0006
71086673|NCT01249417|141678909|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.65||||0.0031|TWO_SIDED|95.0|1.59|7.71|||ANOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANOVA on the visit value with treatment, age range at baseline, BTX status at baseline and centre as covariates.||7.71|1.59|0.0031
71086674|NCT01421498|141678939|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|0.24||||0.0007|TWO_SIDED|95.0|0.1|0.38|||t-test, 2 sided|||||0.38|0.10|0.0007
71086675|NCT01421498|141678940|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|-0.02||||0.786|TWO_SIDED|95.0|-0.15|0.11|||t-test, 2 sided|||||0.11|-0.15|0.7860
71086676|NCT00243919|141678945|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.831||||0.481|TWO_SIDED|95.0|0.497|1.391||The trial tested the superiority of LTP delivered early or late, compared to HEP, using a two-sided significance level of 0.05. The study-wide error rate was controlled by applying the Hochberg step-up procedure to the two primary comparisons.|Regression, Logistic|||Logistic regression was used to compare the proportion of participants who improved functional level of walking between Early-LTP and HEP adjusting for pre-specified covariates (severity of impairment, clinical site, age, stroke type, side of hemiparesis and depression). Assuming that 30% of HEP participants would improve functional level of walking, we derived a sample size of 400 to detect a clinically relevant 20% effect size with 85% power, adjusting for an loss-to-follow-up rate of 15%.||1.391|0.497|0.481
71124275|NCT01073930|141754465|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|11.4|||||ONE_SIDED|97.5|5.2|||||||Overall: Ascending, mid, and recto-sigmoid colon comparison|||5.2|
71124276|NCT01073930|141754466|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71124277|NCT01073930|141754467|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
71124278|NCT01073930|141754468|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71124279|NCT01073930|141754469|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71124280|NCT01073930|141754470|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
71124281|NCT01073930|141754471|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
71124282|NCT01266590|141754478|SUPERIORITY_OR_OTHER|||||||0.0664||95.0|||||Wilcoxon Signed Rank|||||||0.0664
71124283|NCT02198794|141754497|OTHER||Least Square (LS) Mean Difference|-0.6||||0.121|TWO_SIDED|95.0|-1.42|0.17||Threshold for significance at 0.05 level.|ANCOVA|||The statistical model was an analysis of covariance (ANCOVA) with treatment group and dopamine receptor antagonist status at the pre-withdrawal visit as fixed effects and the pre-withdrawal visit value as a covariate.||0.17|-1.42|0.121
71124284|NCT02252965|141754525|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin of this efficacy outcome measure is -0.4%.|Least Squares (LS) Mean Difference|0.03|||||TWO_SIDED|95.0|-0.1|0.17||||||||0.17|-0.10|
71124285|NCT02252965|141754526|SUPERIORITY_OR_OTHER||Percentage difference|-1.52||||0.674|TWO_SIDED|95.0|-8.6|5.56|||Mantel Haenszel|||||5.56|-8.60|0.674
71124286|NCT00167388|141754537|SUPERIORITY_OR_OTHER|||||||0.571|||||||Wilcoxon (Mann-Whitney)|||Change in mean mesenteric blood flow velocity from pre- to post- feed in the anemic state for babies \<1250 gm||||0.571
71124287|NCT00167388|141754537|SUPERIORITY_OR_OTHER|||||||0.345|||||||Wilcoxon (Mann-Whitney)|||change in peak systolic blood flow velocity from pre-to post feed for babies \<1250 gm while anemic||||0.345
71124288|NCT00167388|141754537|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||Change in superior mesenteric artery blood flow velocity from pre- to post- feed in the anemic state for babies \>1250 gm||||0.006
71124289|NCT00167388|141754537|SUPERIORITY_OR_OTHER|||||||0.035|||||||Wilcoxon (Mann-Whitney)|||change in peak systolic blood flow velocity from pre-to post feed for babies \>1250 gm while anemic||||0.035
71124290|NCT00167388|141754537|SUPERIORITY_OR_OTHER|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||Change in mean mesenteric blood flow velocity from pre-to post-feed for babies \<1250 gm after the PRBC transfusion||||0.910
71124291|NCT00167388|141754537|SUPERIORITY_OR_OTHER|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||Change in Peak systolic mesenteric blood flow velocity from pre-to post-feed for babies \<1250 gm after the PRBC transfusion||||0.850
71124292|NCT00167388|141754537|SUPERIORITY_OR_OTHER|||||||0.507|||||||Wilcoxon (Mann-Whitney)|||Change in mean mesenteric blood flow velocity from pre-to post-feed for babies \>1250 gm after the PRBC transfusion||||0.507
71124293|NCT00167388|141754537|SUPERIORITY_OR_OTHER|||||||0.286|||||||Wilcoxon (Mann-Whitney)|||Change in peak systolic mesenteric blood flow velocity from pre-to post-feed for babies \>1250 gm after the PRBC transfusion||||0.286
71124294|NCT05501795|141754559|OTHER||Mean Difference (Final Values)|-2.1|STANDARD_DEVIATION|5.8|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||< 0.001
71124295|NCT05149313|141754566|SUPERIORITY||Difference in percentages|27.88|||<|0.0001|TWO_SIDED|95.0|15.63|40.14|||Cochran-Mantel-Haenszel|||||40.14|15.63|<0.0001
71124296|NCT05149313|141754567|SUPERIORITY||Difference in percentages|17.8||||0.0052|TWO_SIDED|95.0|7.03|28.57|||Cochran-Mantel-Haenszel|||||28.57|7.03|0.0052
71124297|NCT05149313|141754568|SUPERIORITY||Difference in percentages|18.15||||0.0114|TWO_SIDED|95.0|5.47|30.83|||Cochran-Mantel-Haenszel|||||30.83|5.47|0.0114
71124298|NCT04736628|141754598|OTHER||Mean Difference (Net)|-0.228||||0.0179|TWO_SIDED|95.0|-0.417|-0.04|||Mixed-effect Model repeat Measurement||"Least Squares Mean of Avenciguat 1 mg TID - Least Squares Mean of Placebo."|Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||-0.040|-0.417|0.0179
71124299|NCT04736628|141754598|OTHER||Mean Difference (Net)|-0.209||||0.0307|TWO_SIDED|95.0|-0.398|-0.02|||Mixed-effect Model repeat Measurement||"Least Squares Mean of Avenciguat 2 mg TID - Least Squares Mean of Placebo."|Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||-0.020|-0.398|0.0307
71124300|NCT04736628|141754598|OTHER||Mean Difference (Net)|-0.235||||0.0151|TWO_SIDED|95.0|-0.425|-0.046|||Mixed-effect Model repeat Measurement||"Least Squares Mean of Avenciguat 3 mg TID - Least Squares Mean of Placebo."|Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||-0.046|-0.425|0.0151
71086677|NCT00243919|141678945|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.192||||0.501|TWO_SIDED|95.0|0.715|1.985|||Regression, Logistic|||Logistic regression was used to compare the proportion of participants who improved functional level of walking between Late-LTP and HEP adjusting for pre-specified covariates (severity of impairment, clinical site, age, stroke type, side of hemiparesis and depression).||1.985|0.715|0.501
71086678|NCT00243919|141678946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.242||95.0||||We did not formally conduct statistical inference on the timing effect because the first primary null hypotheses is accepted. The p-value provided is the smallest alpha level that one would claim significant difference between early- and late-LTP.|Regression, Linear||Even though there was no formal inference of timing effect, we still provided descriptive statistics for the 6-month and 12-month changes. In addition, paired t-tests were used to compare within-group improvements.|The second primary analysis assessed the timing effect and its interaction with initial severity of gait impairment on walking speed change from baseline to 1 year after stroke.||||0.242
71086679|NCT00243919|141678947|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.94||||0.01|TWO_SIDED|95.0|1.18|3.21|||Regression, Logistic|Pairwise comparisons were conducted: Early-LTP versus Late-LTP, which had received only usual care in the 2- to 6-month post-stroke period.||Logistic regression was used to compare the proportion of participants who improved functional level of walking between early-LTP and Late-LTP (Usual Care) adjusting for pre-specified covariates (severity of impairment, clinical site, age, stroke type, side of hemiparesis and depression).||3.21|1.18|0.010
71124301|NCT04736628|141754598|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||||||0.0053|||||||MCP-Mod E-max model fit|Model assumption: 80% of the maximum effect is achieved at 6 mg.||"A flat vs. non-flat dose-response relationship across the 3 doses of avenciguat and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (Emax, exponential, linear, quadratic, sigmoid emax) while protecting the overall probability of type I error (one-sided alpha of 0.050).~The total daily dose was considered for MCP-Mod analysis (placebo, active avenciguat 3 mg, 6 mg, and 9 mg)."||||0.0053
71124302|NCT04736628|141754598|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||||||0.0102|||||||MCP-Mod quadratic model fit|Model assumption: 50 % of the maximum effect is achieved at a dose of 3 mg. 90 % of the maximum effect is achieved at a dose of 6 mg.||"A flat vs. non-flat dose-response relationship across the 3 doses of avenciguat and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (Emax, exponential, linear, quadratic, sigmoid emax) while protecting the overall probability of type I error (one-sided alpha of 0.050).~The total daily dose was considered for MCP-Mod analysis (placebo, active avenciguat 3 mg, 6 mg, and 9 mg)."||||0.0102
71124303|NCT04736628|141754598|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||||||0.023|||||||MCP-Mod linear model fit|Model assumption: no assumption is needed.||"A flat vs. non-flat dose-response relationship across the 3 doses of avenciguat and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (Emax, exponential, linear, quadratic, sigmoid emax) while protecting the overall probability of type I error (one-sided alpha of 0.050).~The total daily dose was considered for MCP-Mod analysis (placebo, active avenciguat 3 mg, 6 mg, and 9 mg)."||||0.0230
71124304|NCT04736628|141754598|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||||||0.0292|||||||MCP-Mod Sigmoid Emax model fit|Model assumption: 30 % of the maximum effect is achieved at a dose of 3 mg. 90 % of the maximum effect is achieved at a dose of 6 mg.||"A flat vs. non-flat dose-response relationship across the 3 doses of avenciguat and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (Emax, exponential, linear, quadratic, sigmoid emax) while protecting the overall probability of type I error (one-sided alpha of 0.050).~The total daily dose was considered for MCP-Mod analysis (placebo, active avenciguat 3 mg, 6 mg, and 9 mg)."||||0.0292
71124305|NCT04736628|141754598|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||||||0.0468|||||||MCP-Mod Exponential model fit|Model assumption: 20% of the maximum effect is achieved at 3 mg.||"A flat vs. non-flat dose-response relationship across the 3 doses of avenciguat and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (Emax, exponential, linear, quadratic, sigmoid emax) while protecting the overall probability of type I error (one-sided alpha of 0.050).~The total daily dose was considered for MCP-Mod analysis (placebo, active avenciguat 3 mg, 6 mg, and 9 mg)."||||0.0468
71124306|NCT04736628|141754599|OTHER||Mean Difference (Net)|-0.217||||0.0327|TWO_SIDED|95.0|-0.416|-0.018|||Mixed-effect Model repeat Measurement||"Least Squares Mean of Avenciguat 1 mg TID - Least Squares Mean of Placebo."|Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||-0.018|-0.416|0.0327
71124307|NCT04736628|141754599|OTHER||Mean Difference (Net)|-0.206||||0.0447|TWO_SIDED|95.0|-0.408|-0.005|||Mixed-effect Model repeat Measurement||"Least Squares Mean of Avenciguat 2 mg TID - Least Squares Mean of Placebo."|Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||-0.005|-0.408|0.0447
71124308|NCT04736628|141754599|OTHER||Mean Difference (Net)|-0.187||||0.0654|TWO_SIDED|95.0|-0.387|0.012|||Mixed-effect Model repeat Measurement||"Least Squares Mean of Avenciguat 3 mg TID - Least Squares Mean of Placebo."|Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||0.012|-0.387|0.0654
71124309|NCT04736628|141754600|OTHER||Odds Ratio (OR)|2.2||||0.0476|TWO_SIDED|95.0|1.01|4.79||Nominal p-value.|Regression, Logistic||Odds ratio (Avenciguat 1 mg TID vs. Placebo).|Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.||4.79|1.01|0.0476
71124310|NCT04736628|141754600|OTHER||Odds Ratio (OR)|2.72||||0.0119|TWO_SIDED|95.0|1.25|5.94||Nominal p-value.|Regression, Logistic||Odds ratio (Avenciguat 2 mg TID vs. Placebo).|Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.||5.94|1.25|0.0119
71124311|NCT04736628|141754600|OTHER||Odds Ratio (OR)|3.43||||0.0019|TWO_SIDED|95.0|1.58|7.45||Nominal p-value.|Regression, Logistic||Odds ratio (Avenciguat 3 mg TID vs. Placebo).|Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.||7.45|1.58|0.0019
71124312|NCT04736628|141754601|OTHER||Odds Ratio (OR)|2.13||||0.0497|TWO_SIDED|95.0|1.0|4.55||Nominal p-value.|Regression, Logistic||Odds ratio (Avenciguat 1 mg TID vs. Placebo).|Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.||4.55|1.00|0.0497
71124313|NCT04736628|141754601|OTHER||Odds Ratio (OR)|2.15||||0.0502|TWO_SIDED|95.0|1.0|4.61||Nominal p-value.|Regression, Logistic||Odds ratio (Avenciguat 2 mg TID vs. Placebo).|Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.||4.61|1.00|0.0502
71124314|NCT04736628|141754601|OTHER||Odds Ratio (OR)|2.09||||0.0572|TWO_SIDED|95.0|0.98|4.49||Nominal p-value.|Regression, Logistic||Odds ratio (Avenciguat 3 mg TID vs. Placebo).|Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.||4.49|0.98|0.0572
71124315|NCT02046070|141754631|OTHER|||||||0.4859|||||||Chi-squared|||P-value tests the null hypothesis: CR+VGPR rate=27% in treatment arms obtained using the one-sided Chi-Square test with alpha=0.10.||||0.4859
71124316|NCT02046070|141754631|OTHER|||||||0.6757|||||||Chi-squared|||P-value tests the null hypothesis: CR+VGPR rate=27% in treatment arms obtained using the one-sided Chi-Square test with alpha=0.10.||||0.6757
71124317|NCT02046070|141754632|OTHER|||||||0.9688|||||||Chi-squared|||P-value tests the null hypothesis: CR+VGPR+PR rate=60% obtained using the one-sided Chi-Square test with alpha=0.10.||||0.9688
71124318|NCT05432167|141754683|SUPERIORITY||Mean Difference (Final Values)|-8.08|STANDARD_ERROR_OF_MEAN|2.676||0.003|TWO_SIDED|95.0|-13.36|-2.79|||Mixed Models Analysis|||The analysis was performed using a mixed-effect model for repeated measures including fixed effects for treatment, visit, stratification variables (SGLT2 inhibitor use and CKD category), and the treatment-by-visit interaction, along with a covariate of the baseline seated SBP value and the baseline seated SBP by visit interaction.||-2.79|-13.36|0.003
71124319|NCT05432167|141754684|SUPERIORITY||Mean Difference (Final Values)|-7.22|STANDARD_ERROR_OF_MEAN|3.051||0.019|TWO_SIDED|95.0|-13.24|-1.19|||Mixed Models Analysis|||The analysis was performed using a mixed-effect model for repeated measures including fixed effects for treatment, visit, stratification variables (SGLT2 inhibitor use and CKD category), and the treatment-by-visit interaction, along with a covariate of the baseline seated SBP value and the baseline seated SBP by visit interaction.||-1.19|-13.24|0.019
70945302|NCT01475461|141391151|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.098||0.0031|TWO_SIDED|80.0|-0.4|-0.15||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, as the covariates, time was repeated for participant.||-0.15|-0.40|0.0031
71124320|NCT05432167|141754685|SUPERIORITY||Mean Difference (Final Values)|-8.99|STANDARD_ERROR_OF_MEAN|3.098||0.004|TWO_SIDED|95.0|-15.1|-2.87|||Mixed Models Analysis|||The analysis was performed using a mixed-effect model for repeated measures including fixed effects for treatment, visit, stratification variables (SGLT2 inhibitor use and CKD category), and the treatment-by-visit interaction, along with a covariate of the baseline seated SBP value and the baseline seated SBP by visit interaction.||-2.87|-15.10|0.004
71124321|NCT00140842|141754689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|15.0|STANDARD_DEVIATION|16.0|<|0.05||95.0|||||t-test, 2 sided|||The null hypothesis was that there is no difference between the groups for peak growth hormone on the growth hormone stimulation test.||||<0.05
71124322|NCT00140842|141754690|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|23.7|STANDARD_DEVIATION|12.0|<|0.05||95.0|||||t-test, 2 sided|||The null hypothesis is that there is no difference between the groups for visceral adipose tissue||||<0.05
71124323|NCT02553538|141754692|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71124324|NCT02553538|141754693|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Regression, Logistic|||||||<0.001
71124325|NCT02553538|141754694|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Regression, Logistic|||||||<0.001
71124326|NCT02553538|141754695|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71124327|NCT02690649|141754708|SUPERIORITY||estimated adherence rate for the interve|94.0||||0.28|TWO_SIDED|95.0|92.0|95.0|||Regression, Linear|||estimated adherence rate for the intervention group Generalized linear models were used to test the effect of the intervention on medication adherence. These generalized linear models used a Poisson distribution to estimate the rate of adherence with the log of total prescribed doses as an offset term in the linear predictor.||95|92|0.28
71124328|NCT02690649|141754709|SUPERIORITY||||||<|0.001||||||A negative binomial distribution because the outcome was a count variable and it was over-dispersed.|Regression, Linear|Age, previous patient portal logins, and gender were used as co-variates in the model.||||||<0.001
71124329|NCT02690649|141754710|SUPERIORITY||Slope|-0.61||||0.03|TWO_SIDED|95.0|-1.14|-0.07||baseline AF knowledge, gender, age, and educational level were all used as co-variates.|Regression, Linear|generalized linear model tested whether AF knowledge at study completion was related to baseline AF knowledge, gender, age, and educational level||||-0.07|-1.14|0.03
71124330|NCT00110461|141754722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.99|||<|0.0001|TWO_SIDED|95.0|-8.49|-3.5|||t-test, 2 sided|||The change scores were analyzed by using ANCOVA model with treatment as a factor and baseline Y-MRS total score as a covariate. For comparing YMRS-Total score in treatment groups at baseline, only treatment was included in the ANOVA model with baseline values as the dependent variable. The LS means obtained from a type III analysis using SAS were used for the treatment comparisons. Two-tailed student's t-tests were used to test differences between the LS means within the ANCOVA or ANOVA model.||-3.5|-8.49|<0.0001
71124331|NCT00110461|141754722|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-8.26|||<|0.0001|TWO_SIDED|95.0|-10.7|-5.77|||t-test, 2 sided|||The change scores were analyzed by using ANCOVA model with treatment as a factor and baseline Y-MRS total score as a covariate. For comparing YMRS-Total score in treatment groups at baseline, only treatment was included in the ANOVA model with baseline values as the dependent variable. The LS means obtained from a type III analysis using SAS were used for the treatment comparisons. Two-tailed student's t-tests were used to test differences between the LS means within the ANCOVA or ANOVA model.||-5.77|-10.7|<0.0001
71124332|NCT00110461|141754723|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-5.89|||<|0.0001|TWO_SIDED|95.0|-8.7|-3.08|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-3.08|-8.7|<0.0001
71124333|NCT00110461|141754723|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|11.51|||<|0.0001|TWO_SIDED|95.0|7.99|15.03|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||15.03|7.99|<0.0001
71124334|NCT00110461|141754724|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|9.3|||<|0.0001|TWO_SIDED|95.0|5.77|12.84|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||12.84|5.77|<0.0001
71124335|NCT00110461|141754724|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|11.51|||<|0.0001|TWO_SIDED|95.0|7.99|15.03|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||15.03|7.99|<0.0001
70945303|NCT01475461|141391151|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.098||0.0005|TWO_SIDED|80.0|-0.45|-0.2||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.20|-0.45|0.0005
71124336|NCT00110461|141754725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81|||<|0.0001|TWO_SIDED|95.0|-1.15|-0.48|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.48|-1.15|<0.0001
71124337|NCT00110461|141754725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|||<|0.0001||95.0|-1.59|-0.93|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.93|-1.59|<0.0001
71124338|NCT00110461|141754726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.28||||0.0767|TWO_SIDED|95.0|-4.81|0.25|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||0.25|-4.81|0.0767
71124339|NCT00110461|141754726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19||||0.3515|TWO_SIDED|95.0|-3.69|1.32|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.32|-3.69|0.3515
71124340|NCT00110461|141754727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.88|||<|0.0001|TWO_SIDED|95.0|-8.02|-3.73|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-3.73|-8.02|<0.0001
71124341|NCT00110461|141754727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.46|||<|0.0001|TWO_SIDED|95.0|-7.4|-3.32|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-3.32|-7.40|<0.0001
71124342|NCT00110461|141754728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.86|||<|0.0001|TWO_SIDED|95.0|-12.3|-5.43|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-5.43|-12.3|<0.0001
71124343|NCT00110461|141754728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.23|||<|0.0001|TWO_SIDED|95.0|-11.6|-4.83|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-4.83|-11.6|<0.0001
71124344|NCT00110461|141754729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.23|||<|0.0001|TWO_SIDED|95.0|5.07|13.93|||t-test, 2 sided|||||13.93|5.07|<0.0001
71124345|NCT00110461|141754729|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|10.0|||<|0.0001|TWO_SIDED|95.0|5.87|14.14|||t-test, 2 sided|||||14.14|5.87|<0.0001
71124346|NCT00110461|141754730|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.7||||0.0003|TWO_SIDED|95.0|-1.08|-0.33|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.33|-1.08|0.0003
71124347|NCT00110461|141754730|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.04|||<|0.0001|TWO_SIDED|95.0|-1.41|-0.66|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.66|-1.41|<0.0001
71124348|NCT00110461|141754731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0878|TWO_SIDED|95.0|-0.54|0.04|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||0.04|-0.54|0.0878
71124349|NCT00110461|141754731|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.26||||0.0752|TWO_SIDED|95.0|-0.55|0.03|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||0.03|-0.55|0.0752
71124350|NCT00110461|141754732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.2553|TWO_SIDED|95.0|-0.51|0.13|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||0.13|-0.51|0.2553
71124351|NCT00110461|141754732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.0166|TWO_SIDED|95.0|-0.71|-0.07|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.07|-0.71|0.0166
71124352|NCT00110461|141754733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|||<|0.0001|TWO_SIDED|95.0|-1.16|-0.51|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.51|-1.16|<0.0001
71124353|NCT00110461|141754733|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.18|||<|0.0001|TWO_SIDED|95.0|-1.51|-0.86|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.86|-1.51|<0.0001
71124354|NCT00110461|141754734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76|||<|0.0001|TWO_SIDED|95.0|-1.13|-0.4|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.40|-1.13|<0.0001
70945304|NCT01475461|141391151|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.144||0.5133|TWO_SIDED|80.0|-0.18|0.19||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.19|-0.18|0.5133
70945305|NCT01475461|141391151|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.15||0.1873|TWO_SIDED|80.0|-0.33|0.06||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.06|-0.33|0.1873
70945306|NCT01475461|141391151|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.145||0.212|TWO_SIDED|80.0|-0.3|0.07||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.07|-0.30|0.2120
70945307|NCT01475461|141391151|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.146||0.0001|TWO_SIDED|80.0|-0.73|-0.35||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, as the covariates, time was repeated for participant.||-0.35|-0.73|0.0001
70945308|NCT01475461|141391151|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.146||0.0021|TWO_SIDED|80.0|-0.61|-0.23||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.23|-0.61|0.0021
70945309|NCT01475461|141391152|SUPERIORITY_OR_OTHER||LS Mean Difference|2.87|STANDARD_ERROR_OF_MEAN|4.823||0.724|TWO_SIDED|80.0|-3.32|9.07||p-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80 percent(%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||9.07|-3.32|0.7240
71086680|NCT00243919|141678947|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04||||0.007|TWO_SIDED|95.0|1.22|3.42|||Regression, Logistic|Pairwise comparisons were conducted: HEP versus Late-LTP, which had received only usual care in the 2- to 6-month post-stroke period.||Logistic regression was used to compare the proportion of participants who improved functional level of walking between HEP and Late-LTP (Usual Care) adjusting for pre-specified covariates (severity of impairment, clinical site, age, stroke type, side of hemiparesis and depression).||3.42|1.22|0.007
71086681|NCT00243919|141678948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|||<|0.0001|TWO_SIDED|95.0|0.08|0.16||Bonferroni adjustment for multiple testing was used in the pair-wise comparisons of the secondary outcomes. A difference is claimed to be statistically significant when p\<0.0014.|t-test, 2 sided|||6 month secondary analysis. Following the overall ANOVA test, pairwise comparison was conducted to assess differences in walking speed changes between early-LTP and late-LTP.||0.16|0.08|<0.0001
71086682|NCT00243919|141678948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||<|0.0001|TWO_SIDED|95.0|0.05|0.14||Bonferroni adjustment for multiple testing was used in the pair-wise comparisons of the secondary outcomes. A difference is claimed to be statistically significant when p\<0.0014.|t-test, 2 sided|||6 month secondary analysis. Following the overall ANOVA test, pairwise comparison was conducted to assess differences in walking speed changes between HEP and late-LTP.||0.14|0.05|<.0001
71086683|NCT00243919|141678949|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||Test differences across the three groups in change of 6 minute walking distance from baseline to 12-month post stroke.|ANOVA|||Primary 12 month analysis. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.45
70945310|NCT01475461|141391152|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.77|STANDARD_ERROR_OF_MEAN|4.952||0.3608|TWO_SIDED|80.0|-8.13|4.59||p-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||4.59|-8.13|0.3608
71086684|NCT00243919|141678949|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|Test differences across the three groups in change of 6 minute walking distance from baseline to 6-month post stroke.||6 month secondary analysis. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||<0.001
71124355|NCT00110461|141754734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|||<|0.0001|TWO_SIDED|95.0|-1.33|-0.6|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.60|-1.33|<0.0001
71124356|NCT00110461|141754735|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.92||||0.1729|TWO_SIDED|95.0|-4.69|0.85|||t-test, 2 sided|||||0.85|-4.69|0.1729
71124357|NCT00110461|141754735|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.43||||0.75586|TWO_SIDED|95.0|-3.17|2.31|||t-test, 2 sided|||||2.31|-3.17|0.75586
70945311|NCT01475461|141391152|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.24|STANDARD_ERROR_OF_MEAN|4.816||0.2511|TWO_SIDED|80.0|-9.42|2.95||p-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.95|-9.42|0.2511
70945312|NCT01475461|141391152|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.28|STANDARD_ERROR_OF_MEAN|4.851||0.0673|TWO_SIDED|80.0|-13.51|-1.05||p-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-1.05|-13.51|0.0673
70945313|NCT01475461|141391152|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.22|STANDARD_ERROR_OF_MEAN|4.843||0.0106|TWO_SIDED|80.0|-17.44|-5.0||p-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-5.00|-17.44|0.0106
70945314|NCT01475461|141391152|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|5.138||0.4127|TWO_SIDED|80.0|-7.73|5.47||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||5.47|-7.73|0.4127
71086685|NCT00243919|141678950|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Kruskal-Wallis|Test differences across the three groups in change of number of steps from baseline to 12-month post stroke.||12 month primary outcome. The Kruskal-Wallis procedure was used to assess differences across the three groups in number of steps taken in the community. Wilcoxon signed rank tests were used to compare within-group improvements.||||0.10
71086686|NCT00243919|141678950|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Kruskal-Wallis|Test differences across the three groups in change of number of steps from baseline to 6-month post stroke.||6 month secondary analysis. The Kruskal-Wallis procedure was used to assess differences across the three groups in number of steps taken in the community. Wilcoxon signed rank tests were used to compare within-group improvements.||||0.04
71086687|NCT00243919|141678951|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||ANOVA|Test differences across the three groups in change of SIS Participation from baseline to 12-month post stroke.||12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.48
71086688|NCT00243919|141678951|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||ANOVA|Test differences across the three groups in change of SIS Participation from baseline to 6-month post stroke.||6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.06
71086689|NCT00243919|141678952|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||ANOVA|Test differences across the three groups in change of SIS ADL/iADL from baseline to 12-month post stroke.||12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.07
71124358|NCT00110461|141754736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.76|||<|0.0001|TWO_SIDED|95.0|-6.9|-2.61|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-2.61|-6.90|<0.0001
71124359|NCT00110461|141754736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.64|||<|0.0001|TWO_SIDED|95.0|-6.78|-2.5|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-2.50|-6.78|<0.0001
71124360|NCT00110461|141754737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.85||||0.0468|TWO_SIDED|95.0|-3.67|-0.03|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.03|-3.67|0.0468
71124361|NCT00110461|141754737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.03||||0.0296|TWO_SIDED|95.0|-3.85|-0.2|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.20|-3.85|0.0296
71124362|NCT00110461|141754738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.44||||0.1309|TWO_SIDED|95.0|-3.31|0.43|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||0.43|-3.31|0.1309
71124363|NCT00110461|141754738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.64||||0.0058|TWO_SIDED|95.0|-4.51|-0.77|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.77|-4.51|0.0058
71124364|NCT00110461|141754739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.13||||0.043|TWO_SIDED|95.0|-4.2|-0.07|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.07|-4.20|0.0430
71124365|NCT00110461|141754739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.7696|TWO_SIDED|95.0|-2.37|1.76|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.76|-2.37|0.7696
71124366|NCT00110461|141754740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.9418|TWO_SIDED|95.0|-1.73|1.86|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.86|-1.73|0.9418
71124367|NCT00110461|141754740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.19|TWO_SIDED|95.0|-1.67|1.98|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.98|-1.67|0.19
70945315|NCT01475461|141391152|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.88|STANDARD_ERROR_OF_MEAN|5.261||0.3604|TWO_SIDED|80.0|-8.64|4.87||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||4.87|-8.64|0.3604
70945316|NCT01475461|141391152|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.35|STANDARD_ERROR_OF_MEAN|5.147||0.077|TWO_SIDED|80.0|-13.96|-0.74||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.74|-13.96|0.0770
71086690|NCT00243919|141678952|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANOVA|Test differences across the three groups in change of SIS ADL/iADL from baseline to 6-month post stroke.||6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.03
71086691|NCT00243919|141678953|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||ANOVA|Test differences across the three groups in change of SIS Mobility from baseline to 12-month post stroke.||12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.69
71086692|NCT00243919|141678953|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|Test differences across the three groups in change of SIS Mobility from baseline to 6-month post stroke.||6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||<.0001
71124368|NCT00110461|141754741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.9418|TWO_SIDED|95.0|-1.73|1.86|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.86|-1.73|0.9418
71124369|NCT00110461|141754741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.8377|TWO_SIDED|95.0|-1.61|1.98|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.98|-1.61|0.8377
71124370|NCT00110461|141754742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.3969|TWO_SIDED|95.0|-2.71|1.08|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.08|-2.71|0.3969
71124371|NCT00110461|141754742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.2101|TWO_SIDED|95.0|-3.09|0.68|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||0.68|-3.09|0.2101
71124372|NCT00110461|141754743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.05|||<|0.0001|TWO_SIDED|95.0|-10.5|-3.64|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-3.64|-10.5|<0.0001
70945317|NCT01475461|141391152|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.79|STANDARD_ERROR_OF_MEAN|5.171||0.0451|TWO_SIDED|80.0|-15.43|-2.15||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-2.15|-15.43|0.0451
71086693|NCT00243919|141678954|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||ANOVA|Test differences across the three groups in change of FM-LE from baseline to 12-month post stroke.||12 month primary analysis. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.13
71086694|NCT00243919|141678954|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|Test differences across the three groups in change of FM-LE from baseline to 6-month post stroke.||6 month secondary analysis. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.04
71086695|NCT00243919|141678955|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||ANOVA|Test differences across the three groups in change of Berg Balance Score from baseline to 12-month post stroke.||12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.06
71086696|NCT00243919|141678955|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|Test differences across the three groups in change of Berg Balance Score from baseline to 6-month post stroke.||6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.001
71086697|NCT00243919|141678956|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||ANOVA|Test differences across the three groups in change of ABC score from baseline to 12-month post stroke.||12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.62
71086698|NCT00243919|141678956|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|Test differences across the three groups in change of ABC score from baseline to 6-month post stroke.||6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||<0.001
71086699|NCT02059239|141678959|OTHER|Simple proportion in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|88.9|||||TWO_SIDED|95.0|65.3|98.6||||||||98.6|65.3|
71086700|NCT02059239|141678959|OTHER|Simple proportion in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|81.3|||||TWO_SIDED|95.0|54.4|95.9||||||||95.9|54.4|
71086701|NCT02059239|141678960|OTHER|Simple proportion in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|100.0|||||TWO_SIDED|95.0|79.4|100.0||||||||100.0|79.4|
71086702|NCT02059239|141678960|OTHER|Simple proportion in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|100.0|||||TWO_SIDED|95.0|75.3|100.0||||||||100.0|75.3|
71086703|NCT02059239|141678961|OTHER|Simple proportion in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|100.0|||||TWO_SIDED|95.0|79.4|100.0||||||||100.0|79.4|
71086704|NCT02059239|141678961|OTHER|Simple proportion in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|92.3|||||TWO_SIDED|95.0|64.0|99.8||||||||99.8|64.0|
71086705|NCT02059239|141678962|OTHER|Simple proportion in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|100.0|||||TWO_SIDED|95.0|79.4|100.0||||||||100.0|79.4|
71086706|NCT02059239|141678962|OTHER|Simple proportion in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|84.6|||||TWO_SIDED|95.0|54.6|98.1||||||||98.1|54.6|
71086707|NCT02059239|141678963|OTHER|Simple proportion in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|100.0|||||TWO_SIDED|95.0|79.4|100.0||||||||100.0|79.4|
71086708|NCT02059239|141678963|OTHER|Simple proportion in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|46.2|||||TWO_SIDED|95.0|19.2|74.9||||||||74.9|19.2|
70856957|NCT02446743|141200497|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|vaccine group ratio of GMTs|2.13|||||TWO_SIDED|95.0|1.66|2.72|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||2.72|1.66|
70945318|NCT01475461|141391152|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.9|STANDARD_ERROR_OF_MEAN|5.191||0.0001|TWO_SIDED|80.0|-26.57|-13.23||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-13.23|-26.57|0.0001
71086709|NCT02059239|141678964|OTHER|Simple proportion in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|0.0|||||TWO_SIDED|95.0|0.0|20.6||||||||20.6|0.0|
71086710|NCT02059239|141678964|OTHER|Simple proportion in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|15.4|||||TWO_SIDED|95.0|1.9|45.4||||||||45.4|1.9|
71086711|NCT02059239|141678965|OTHER|Simple proportion (objective response: CR+PR) in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|66.7|||||TWO_SIDED|95.0|41.0|86.7||||||||86.7|41.0|
71086712|NCT02059239|141678965|OTHER|Simple proportion (objective response: CR+PR) in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|43.8|||||TWO_SIDED|95.0|19.8|70.1||||||||70.1|19.8|
71086713|NCT02059239|141678966|OTHER|Simple proportion (objective response: CR+PR) in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|87.5|||||TWO_SIDED|95.0|61.7|98.4||||||||98.4|61.7|
71086714|NCT02059239|141678966|OTHER|Simple proportion (objective response: CR+PR) in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|76.9|||||TWO_SIDED|95.0|46.2|95.0||||||||95.0|46.2|
71086715|NCT02059239|141678967|OTHER|Simple proportion (objective response: CR+PR) in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|81.3|||||TWO_SIDED|95.0|54.4|96.0||||||||96.0|54.4|
70945319|NCT01475461|141391152|SUPERIORITY_OR_OTHER||LS Mean Difference|1.11|STANDARD_ERROR_OF_MEAN|5.599||0.5783|TWO_SIDED|80.0|-6.08|8.3||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||8.30|-6.08|0.5783
71086716|NCT02059239|141678967|OTHER|Simple proportion (objective response: CR+PR) in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|30.8|||||TWO_SIDED|95.0|9.1|61.4||||||||61.4|9.1|
71086717|NCT02059239|141678968|OTHER|Median PFS in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Median (95% CI)|8.0|||||TWO_SIDED|95.0|5.0|25.0||||||||25|5|
71086718|NCT02318849|141678977|SUPERIORITY||Change in percentage|0.09||||0.009|TWO_SIDED||||||Mixed Models Analysis|The anaylsis was adjusted for student characteristics.||The null hypothesis was that the of number students who report being a donor (or talking to parents about organ donation) both before and after exposure to the intervention would be equivalent. A secondary null hypothesis would be that longer expsosures to the intervention over time would not increase the number who report becoming a donor at the final assessment.||||0.009
71086719|NCT02318849|141678978|SUPERIORITY||Change in percentage|0.0|||>|0.1|TWO_SIDED|||||Calculated|Mixed Models Analysis|||||||>0.10
71086720|NCT00731822|141679008|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.6|||||TWO_SIDED|95.0|-3.9|5.1||||||||5.1|-3.9|
71086721|NCT04585919|141679012|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|Generalized linear mixed effect model controlling for secular trend, patient sociodemographic and health characteristics||||||0.005
71086722|NCT04585919|141679013|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|Generalized linear mixed effect model controlling for secular trend, patient sociodemographic and health characteristics||||||0.19
71086723|NCT01435759|141679122|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean|3.16|STANDARD_ERROR_OF_MEAN|1.01||0.004|TWO_SIDED||||||MCP-Mod Analysis|The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.14, was based on MCP-Mod Analysis for the candidate model EMax.|||||0.004
71086724|NCT01435759|141679122|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|2.5|STANDARD_ERROR_OF_MEAN|1.01||0.032|TWO_SIDED||||||MCP-Mod Analysis|The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 2.48, was based on MCP-Mod Analysis for the candidate model Exponential.|||||0.032
71086725|NCT01435759|141679122|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean|3.28|STANDARD_ERROR_OF_MEAN|1.01||0.003|TWO_SIDED||||||MCP-Mod Analysis|The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.26 was based on MCP-Mod Analysis for the candidate model Linear.|||||0.003
71086726|NCT01435759|141679122|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|2.91|STANDARD_ERROR_OF_MEAN|1.01||0.01|TWO_SIDED||||||MCP-Mod Analysis Method|The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 2.88, was based on MCP-Mod Analysis for the candidate model Logistic1.|||||0.010
71086727|NCT01435759|141679122|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|3.15|STANDARD_ERROR_OF_MEAN|1.01||0.005|TWO_SIDED||||||MCP-Mod Analysis|The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.12, was based on MCP-Mod Analysis for the candidate model Logistic2.|||||0.005
71086728|NCT01435759|141679123|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|2.16|STANDARD_ERROR_OF_MEAN|0.75||0.011|TWO_SIDED||||||MCP-Mod Analysis|The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 2.86 was based on MCP-Mod Analysis for the candidate model Emax.|||||0.011
71086729|NCT01435759|141679123|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|1.95|STANDARD_ERROR_OF_MEAN|0.75||0.023|TWO_SIDED||||||MCP-Mod Analysis|The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 2.59, was based on MCP-Mod Analysis for the candidate model Exponential.|||||0.023
71086730|NCT01435759|141679123|SUPERIORITY_OR_OTHER_LEGACY||MCP-Mod Analysis|2.47|STANDARD_ERROR_OF_MEAN|0.75||0.003|TWO_SIDED||||||Least Squares Means|The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.28, was based on MCP-Mod Analysis for the candidate model Linear.|||||0.003
71086731|NCT01435759|141679123|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|2.22|STANDARD_ERROR_OF_MEAN|0.76||0.009|TWO_SIDED||||||MCP-Mod Analysis|The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 2.93, was based on MCP-Mod Analysis for the candidate model Logistic1.|||||0.009
71086732|NCT01435759|141679123|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|2.37|STANDARD_ERROR_OF_MEAN|0.76||0.005|TWO_SIDED||||||MCP-Mod Analysis|The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.13, was based on MCP-Mod Analysis for the candidate model Logistic2.|||||0.005
71086733|NCT01435759|141679124|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|4.45|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED||||||MCP-Mod Analysis|The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 4.24, was based on MCP-Mod Analysis for the candidate model Emax|||||<0.001
71086734|NCT01435759|141679124|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|3.52|STANDARD_ERROR_OF_MEAN|1.05||0.002|TWO_SIDED||||||MCP-Mod Analysis|The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.36, was based on MCP-Mod Analysis for the candidate model Expontential.|||||0.002
71124373|NCT00110461|141754743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.55||||0.0014|TWO_SIDED|95.0|-8.94|-2.16|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-2.16|-8.94|0.0014
71124374|NCT00110461|141754744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.7||||0.0074|TWO_SIDED|95.0|5.01|32.4|||Chi-squared|||Analyzed using a Chi-square test. Ninety five percent confidence intervals for difference in the responder rates are derived from the normal approximation to binomial.||32.40|5.01|0.0074
71124375|NCT00110461|141754744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.55|||<|0.0001|TWO_SIDED|95.0|23.41|51.68|||Chi-squared|||Analyzed using a Chi-square test. Ninety five percent confidence intervals for difference in the responder rates are derived from the normal approximation to binomial.||51.68|23.41|<0.0001
71124376|NCT00110461|141754745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.4||||0.0009|TWO_SIDED|95.0|9.57|37.24|||Chi-squared|||Analyzed using a Chi-square test. Ninety five percent confidence intervals for difference in the responder rates are derived from the normal approximation to binomial.||37.24|9.57|0.0009
71124377|NCT00110461|141754745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.96|||<|0.0001|TWO_SIDED|95.0|15.05|42.87|||Chi-squared|||Analyzed using a Chi-square test. Ninety five percent confidence intervals for difference in the responder rates are derived from the normal approximation to binomial.||42.87|15.05|<0.0001
71124378|NCT00110461|141754746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|||<|0.0001|TWO_SIDED|95.0|-1.29|-0.66|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.66|-1.29|<0.0001
71124379|NCT00110461|141754746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.39|-0.7|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.70|-1.39|<0.0001
71124380|NCT00110461|141754747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.002|TWO_SIDED|95.0|-1.04|-0.24|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.24|-1.04|0.0020
71124381|NCT00110461|141754747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.0001|TWO_SIDED|95.0|-1.19|-0.41|||Cochran-Mantel-Haenszel|||||-0.41|-1.19|0.0001
71124382|NCT00110461|141754748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.001|TWO_SIDED|95.0|-0.96|-0.26|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.26|-0.96|0.0010
71124383|NCT00110461|141754748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0053|TWO_SIDED|95.0|-0.85|-0.16|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.16|-0.85|0.0053
71124384|NCT00110461|141754749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.1726|TWO_SIDED|95.0|-0.64|0.11|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||0.11|-0.64|0.1726
71124385|NCT00110461|141754749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0113|TWO_SIDED|95.0|-0.89|-0.12|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.12|-0.89|0.0113
71124386|NCT00110461|141754750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99|||<|0.0001|TWO_SIDED|95.0|-1.31|-0.67|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.67|-1.31|<0.0001
71124387|NCT00110461|141754750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.39|-0.72|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.72|-1.39|<0.0001
71124388|NCT00110461|141754751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63||||0.003|TWO_SIDED|95.0|-1.04|-0.22|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.22|-1.04|0.0030
71124389|NCT00110461|141754751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.0001|TWO_SIDED|95.0|-1.18|-0.4|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.40|-1.18|0.0001
71124390|NCT02855944|141754774|SUPERIORITY||Cox Proportional Hazard|0.639||||0.001|TWO_SIDED|95.0|0.489|0.835|||Regression, Cox|||||0.835|0.489|0.0010
71124391|NCT02855944|141754775|SUPERIORITY||Cox Proportional Hazard|0.665||||0.0017|TWO_SIDED|95.0|0.516|0.858|||Regression, Cox|||||0.858|0.516|0.0017
71124392|NCT02855944|141754778|SUPERIORITY||Cox Proportional Hazard|0.589||||0.0401|TWO_SIDED|95.0|0.356|0.976|||Regression, Cox|||||0.976|0.356|0.0401
71124393|NCT02855944|141754779|SUPERIORITY||Cox Proportional Hazard|0.564||||0.024|TWO_SIDED|95.0|0.343|0.927|||Regression, Cox|||||0.927|0.343|0.0240
71124394|NCT03263780|141754878|SUPERIORITY||Sensitivity|0.25||||0.056|TWO_SIDED|95.0|0.19|0.46||mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 6+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 6+)||0.46|0.19|0.056
71124395|NCT03263780|141754878|SUPERIORITY||Sensitivity|0.56||||0.56|TWO_SIDED|95.0|0.44|0.78||mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 6+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 6+)||0.78|0.44|0.56
71124396|NCT03263780|141754878|SUPERIORITY||Sensitivity|0.22||||0.06|TWO_SIDED|95.0|0.17|0.47||mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 6+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 6+)||0.47|0.17|0.060
71124397|NCT03263780|141754878|SUPERIORITY||Sensitivity|0.5||||0.083|TWO_SIDED|95.0|0.39|0.74||mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 6+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 6+)||0.74|0.39|0.083
71124398|NCT03263780|141754879|SUPERIORITY||Sensitivity|0.35||||0.096|TWO_SIDED|95.0|0.26|0.65||mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 7+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 7+)||0.65|0.26|0.096
71124399|NCT03263780|141754879|SUPERIORITY||Sensitivity|0.6||||0.317|TWO_SIDED|95.0|0.46|0.9||mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 7+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 7+)||0.90|0.46|0.317
71124400|NCT03263780|141754879|SUPERIORITY||Sensitivity|0.3||||0.063|TWO_SIDED|95.0|0.23|0.66||mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 7+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 7+)||0.66|0.23|0.063
71124401|NCT03263780|141754879|SUPERIORITY||Sensitivity|0.6||||0.317|TWO_SIDED|95.0|0.46|0.9||mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 7+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 7+)||0.90|0.46|0.317
71124402|NCT03938324|141754891|SUPERIORITY|||||||0.0034||||||The two-tailed significance set at 0.05 was not adjusted for multiple outcomes or comparisons. No adjustments for pairwise comparisons were required for the model.|Multi-level mixed effects|Fixed effects were treatment, time, treatment-by time; whereas, random effects were participant and participant-by-time.||Multi-level mixed effects model for longitudinal data to compare treatment group difference in trajectory across 12 months. Group sizes provided at least 80% power to detect a true difference in change trajectories (treatment-by-time interaction effect), assuming a medium effect size, two-tailed tests, and statistical significance set at 0.05. Null hypothesis was no treatment group difference in the trajectory from baseline to 12 months (no significant treatment-by-time effect).||||0.0034
71124403|NCT03938324|141754892|SUPERIORITY|||||||0.5137||||||The two-tailed significance set at 0.05 was not adjusted for multiple outcomes or comparisons. No adjustments for pairwise comparisons were required for the model.|Multi-level mixed effects|Fixed effects were treatment, time, treatment-by time; whereas, random effects were participant and participant-by-time.||Multi-level mixed effects model for longitudinal data to compare treatment group difference in trajectory across 12 months. Group sizes provided at least 80% power to detect a true difference in change trajectories (treatment-by-time interaction effect), assuming a medium effect size, two-tailed tests, and statistical significance set at 0.05. Null hypothesis was no treatment group difference in the trajectory from baseline to 12 months (no significant treatment-by-time effect).||||0.5137
71124404|NCT03938324|141754893|SUPERIORITY|||||||0.4107||||||The two-tailed significance set at 0.05 was not adjusted for multiple outcomes or comparisons. No adjustments for pairwise comparisons were required for the model.|Multi-level mixed effects|Fixed effects were treatment, time, treatment-by time; whereas, random effects were participant and participant-by-time.||Multi-level mixed effects model for longitudinal data to compare treatment group difference in trajectory across 12 months. Group sizes provided at least 80% power to detect a true difference in change trajectories (treatment-by-time interaction effect), assuming a medium effect size, two-tailed tests, and statistical significance set at 0.05. Null hypothesis was no treatment group difference in the trajectory from baseline to 12 months (no significant treatment-by-time effect).||||0.4107
71124405|NCT03938324|141754894|SUPERIORITY|||||||0.1708||||||The two-tailed significance set at 0.05 was not adjusted for multiple outcomes or comparisons. No adjustments for pairwise comparisons were required for the model.|Multi-level mixed effects|Fixed effects were treatment, time, treatment-by time; whereas, random effects were participant and participant-by-time.||Multi-level mixed effects model for longitudinal data to compare treatment group difference in trajectory across 12 months. Group sizes provided at least 80% power to detect a true difference in change trajectories (treatment-by-time interaction effect), assuming a medium effect size, two-tailed tests, and statistical significance set at 0.05. Null hypothesis was no treatment group difference in the trajectory from baseline to 12 months (no significant treatment-by-time effect).||||0.1708
71124406|NCT03938324|141754895|SUPERIORITY|||||||0.7982||||||The two-tailed significance set at 0.05 was not adjusted for multiple outcomes or comparisons. No adjustments for pairwise comparisons were required for the model.|Multi-level mixed effects|Fixed effects were treatment, time, treatment-by time; whereas, random effects were participant and participant-by-time.||Multi-level mixed effects model for longitudinal data to compare treatment group difference in trajectory across 12 months. Group sizes provided at least 80% power to detect a true difference in change trajectories (treatment-by-time interaction effect), assuming a medium effect size, two-tailed tests, and statistical significance set at 0.05. Null hypothesis was no treatment group difference in the trajectory from baseline to 12 months (no significant treatment-by-time effect).||||0.7982
71124407|NCT05063539|141754920|SUPERIORITY||Posterior Mean Difference|1.68|||||TWO_SIDED|95.0|-0.375|3.771|||||Posterior mean difference with 95% credible interval is reported.|||3.771|-0.375|
71124408|NCT05063539|141754920|SUPERIORITY||Posterior Mean Difference|-3.2|||||TWO_SIDED|95.0|-5.354|-1.042|||||Posterior mean difference with 95% credible interval is reported.|||-1.042|-5.354|
71124409|NCT05063539|141754921|SUPERIORITY||Posterior Mean Difference|1.59|||||TWO_SIDED|95.0|-0.443|3.697|||||Posterior mean difference with 95% credible interval is reported.|||3.697|-0.443|
71124410|NCT05063539|141754921|SUPERIORITY||Posterior Mean Difference|-5.07|||||TWO_SIDED|95.0|-7.277|-2.862||||||||-2.862|-7.277|
71124411|NCT05063539|141754922|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.32||0.665|TWO_SIDED|95.0|-0.763|0.488|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||0.488|-0.763|0.665
71124412|NCT05063539|141754922|SUPERIORITY||LS Mean Difference|1.09|STANDARD_ERROR_OF_MEAN|0.33||0.001|TWO_SIDED|95.0|0.435|1.736|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||1.736|0.435|0.001
71086735|NCT01435759|141679124|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|4.3|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED||||||MCP-Mod Analysis|The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 4.10, was based on MCP-Mod Analysis for the candidate model Linear.|||||<0.001
70856958|NCT02446743|141200497|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|vaccine group ratio of GMTs|2.96|||||TWO_SIDED|95.0|2.15|4.07|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||4.07|2.15|
71086736|NCT01435759|141679124|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|4.63|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED||||||MCP-Mod Analysis|The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 4.39, was based on MCP-Mod Analysis for the candidate model Logistic1.|||||<0.001
71124413|NCT05063539|141754923|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.35||0.878|TWO_SIDED|95.0|-0.641|0.749|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||0.749|-0.641|0.878
71086737|NCT01435759|141679124|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|4.63|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED||||||MCP-Mod Analysis|The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 4.39 was based on MCP-Mod Analysis for the candidate model Logistic2.|||||<0.001
71124414|NCT05063539|141754923|SUPERIORITY||LS Mean Difference|1.33|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|0.615|2.05|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||2.050|0.615|<0.001
71124415|NCT05063539|141754924|SUPERIORITY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.99||0.252|TWO_SIDED|95.0|-3.073|0.811|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||0.811|-3.073|0.252
71124416|NCT05063539|141754924|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|1.03||0.825|TWO_SIDED|95.0|-2.252|1.797|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||1.797|-2.252|0.825
71124417|NCT05063539|141754925|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|1.09||0.733|TWO_SIDED|95.0|-2.527|1.779|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||1.779|-2.527|0.733
71124418|NCT05063539|141754925|SUPERIORITY||LS Mean Difference|1.66|STANDARD_ERROR_OF_MEAN|1.13||0.143|TWO_SIDED|95.0|-0.565|3.877|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||3.877|-0.565|0.143
71124419|NCT05063539|141754926|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|1.0||0.86|TWO_SIDED|95.0|-1.802|2.158|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||2.158|-1.802|0.860
71124420|NCT05063539|141754926|SUPERIORITY||LS Mean Difference|-2.51|STANDARD_ERROR_OF_MEAN|1.04||0.017|TWO_SIDED|95.0|-4.567|-0.456|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||-0.456|-4.567|0.017
71124421|NCT05063539|141754927|SUPERIORITY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|1.1||0.479|TWO_SIDED|95.0|-2.949|1.387|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||1.387|-2.949|0.479
71086738|NCT01435759|141679125|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|-0.11|STANDARD_ERROR_OF_MEAN|1.07||1|ONE_SIDED|||||Any p-value \<=0.10 indicates successful establishment of dose-response relationship.|MCP-Mod Analysis Method|The adjusted p-value was based on a critical value of 2.02 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 0.10, was based on MCP-Mod Analysis from the linear contrast using optimal coefficients for the pre-specified candidate model Betamod.|Analysis of Dose-Response Using the MCP-Mod Analysis Method||||1.000
71086739|NCT01435759|141679125|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|0.43|STANDARD_ERROR_OF_MEAN|1.06||0.942|ONE_SIDED|||||Any p-value \<=0.10 indicates successful establishment of dose-response relationship.|MCP-Mod Analysis|The adjusted p-value was based on a critical value of 2.02 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 0.41, was based on MCP-Mod Analysis from the linear contrast using optimal coefficients for the pre-specified candidate model Emax.|Analysis of Dose-Response Using the MCP-Mod Analysis Method.||||0.942
71086740|NCT01435759|141679125|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|0.21|STANDARD_ERROR_OF_MEAN|1.06||0.995|ONE_SIDED|||||Any p-value \<=0.10 indicates successful establishment of dose-response relationship.|MCP-Mod Analysis|The adjusted p-value was based on a critical value of 2.02 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 0.20, was based on MCP-Mod Analysis from the linear contrast using optimal coefficients for the pre-specified candidate model Linear.|Analysis of Dose-Response Using the MCP-Mod Analysis Method.||||0.995
71086741|NCT01435759|141679125|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|-0.32|STANDARD_ERROR_OF_MEAN|1.07||0.978|ONE_SIDED|||||Any p-value \<=0.10 indicates successful establishment of dose-response relationship.|MCP-Mod Analysis|The adjusted p-value was based on a critical value of 2.02 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 0.30, was based on MCP-Mod Analysis from the linear contrast using optimal coefficients for the pre-specified candidate model Logistic.|Analysis of Dose-Response Using the MCP-Mod Analysis Method||||0.978
71086742|NCT01211145|141679126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.312|TWO_SIDED|95.0|0.75|2.5||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo|||2.50|0.75|.312
71086743|NCT01211145|141679126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.76||||0.071|TWO_SIDED|95.0|0.95|3.26||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo|||3.26|0.95|.071
71086744|NCT01211145|141679126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.18|||<|0.001|TWO_SIDED|95.0|1.4|3.39||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo|||3.39|1.40|<.001
71086745|NCT01211145|141679127|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.575|TWO_SIDED|95.0|0.7|1.91||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo|||1.91|0.70|.575
71086746|NCT01211145|141679127|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87||||0.032|TWO_SIDED|95.0|1.06|3.31||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo|||3.31|1.06|.032
71086747|NCT01211145|141679127|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.137|TWO_SIDED|95.0|0.91|1.95||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo|||1.95|0.91|.137
71086748|NCT01211145|141679128|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.458|TWO_SIDED|95.0|0.74|1.96||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo|||1.96|0.74|.458
71086749|NCT01211145|141679128|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.82||||0.021|TWO_SIDED|95.0|1.09|3.03||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo|||3.03|1.09|.021
71086750|NCT01211145|141679128|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.01|TWO_SIDED|95.0|1.12|2.32||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo|||2.32|1.12|.010
71086751|NCT01211145|141679129|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.753|TWO_SIDED|95.0|0.64|1.84||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo|||1.84|0.64|.753
71086752|NCT01211145|141679129|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.145|TWO_SIDED|95.0|0.86|2.79||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo|||2.79|0.86|.145
71086753|NCT01211145|141679129|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.127|TWO_SIDED|95.0|0.91|2.04||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo|||2.04|0.91|.127
71086754|NCT01211145|141679130|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.274|TWO_SIDED|95.0|0.79|2.32||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo|||2.32|0.79|.274
71086755|NCT01211145|141679130|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.67||||0.067|TWO_SIDED|95.0|0.96|2.91||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo|||2.91|0.96|.067
71086756|NCT01211145|141679130|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.127|TWO_SIDED|95.0|0.91|2.08||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo|||2.08|0.91|.127
71086757|NCT01211145|141679131|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.153|TWO_SIDED|95.0|0.38|1.16||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo|||1.16|0.38|.153
71086758|NCT01211145|141679131|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.087|TWO_SIDED|95.0|0.33|1.08||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo|||1.08|0.33|.087
71086759|NCT01211145|141679131|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.54||||0.004|TWO_SIDED|95.0|0.36|0.83||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo|||0.83|0.36|.004
71086760|NCT02849587|141679138|SUPERIORITY||||||<|0.001|||||||Generalized least squares model|||||||<0.001
71086761|NCT02849587|141679139|SUPERIORITY|||||||0.022|||||||Generalized least squares model|Raw data converted to z-score based on pre-smoking performance of entire sample.||||||0.022
71086762|NCT02849587|141679140|SUPERIORITY|||||||0.283|||||||Generalized least squares model|||||||0.283
71086763|NCT02849587|141679141|SUPERIORITY|||||||0.0503|||||||Generalized estimating equations model|||||||0.0503
71086764|NCT02849587|141679142|SUPERIORITY|||||||0.024|||||||Generalized least squares model|||||||0.024
71086765|NCT02849587|141679143|SUPERIORITY|||||||0.716|||||||Generalized least squares model|The outcome was standardized prior to analyses.||||||0.716
71086766|NCT02849587|141679144|SUPERIORITY|||||||0.005|||||||Generalized least squares model|The outcome was standardized prior to analysis.||||||0.005
71086767|NCT02849587|141679145|SUPERIORITY|||||||0.366|||||||Generalized Estimating Equations model|||||||.366
71086768|NCT02849587|141679146|SUPERIORITY|||||||0.225|||||||Generalized least squares model|Outcome was log10 transformed prior to analyses.||||||.225
71086769|NCT02849587|141679147|SUPERIORITY|||||||0.592|||||||Generalized least squares model|The outcome was transformed using logit function prior to analyses. Model included treatment (3 groups), time (5 times), and their interaction.||||||.592
71086770|NCT02849587|141679148|SUPERIORITY|||||||0.294|||||||Generalized least squares model|||||||.294
71086771|NCT02849587|141679149|SUPERIORITY|||||||0.144|||||||Generalized least squares model|||||||.144
71086772|NCT02849587|141679150|OTHER|Spearman's correlation||||||0.09|||||||Spearman's correlation|||||||0.090
71086773|NCT02849587|141679150|OTHER|Spearman's correlation||||||0.0006|||||||Spearman's correlation|||||||.0006
71086774|NCT02849587|141679150|OTHER|Spearman's correlation||||||0.053|||||||Spearman's correlation|||||||0.053
71086775|NCT02849587|141679151|OTHER|Spearman's correlation||||||0.3|||||||Spearman's correlation|||||||0.300
71086776|NCT02849587|141679151|OTHER|Spearman's correlation||||||0.038|||||||Spearman's correlation|||||||0.038
71086777|NCT02849587|141679151|OTHER|Spearman's correlation||||||0.175|||||||Spearman's correlation|||||||0.175
71086778|NCT01091246|141679191|NON_INFERIORITY_OR_EQUIVALENCE|The noninferior immune response was assessed by evaluating the upper bound of the two-sided 95% confidence intervals for the strain specific HAI antibody GMT ratios (FluMist divided by Q/LAIV) to the noninferiority margin of 1.5.|Ratio of geometric mean|1.07|||||TWO_SIDED|95.0|0.98|1.16|||Bootstrapping|||A/H1N1: The statistical hypothesis testing for the primary endpoint for Q/LAIV was: H0: Rj \> 1.5, for any j HA: Rj ≤ 1.5, for all j Where Rj was any of the 4 strain-specific post immunogenicity dose GMT ratios: (FluMist/B/Yamagata + FluMist/B/Victoria) / (Q/LAIV) for A/H1N1 strain||1.16|0.98|
71086779|NCT01091246|141679191|NON_INFERIORITY_OR_EQUIVALENCE|The noninferior immune response was assessed by evaluating the upper bound of the two-sided 95% confidence intervals for the strain specific HAI antibody GMT ratios (FluMist divided by Q/LAIV) to the noninferiority margin of 1.5. If the upper bounds of 95% CIs were ≤ 1.5 for all 4 strains, the immunologic noninferiority of Q/LAIV compared to FluMist was declared.|Ratio of geometric means|1.04|||||TWO_SIDED|95.0|0.94|1.14|||Bootstrapping|||A/H3N2: The statistical hypothesis testing for the primary endpoint for Q/LAIV was: H0: Rj \> 1.5, for any j HA: Rj ≤ 1.5, for all j Where Rj was any of the 4 strain-specific post immunogenicity dose GMT ratios: (FluMist/B/Yamagata + FluMist/B/Victoria) / (Q/LAIV) for A/H3N2 strain||1.14|0.94|
71086780|NCT01091246|141679191|NON_INFERIORITY_OR_EQUIVALENCE|The noninferior immune response was assessed by evaluating the upper bound of the two-sided 95% confidence intervals for the strain specific HAI antibody GMT ratios (FluMist divided by Q/LAIV) to the noninferiority margin of 1.5. If the upper bounds of 95% CIs were ≤ 1.5 for all 4 strains, the immunologic noninferiority of Q/LAIV compared to FluMist was declared.|Ratio of geometric mean|1.21|||||TWO_SIDED|95.0|1.07|1.37||||||B/Yamagata: The statistical hypothesis testing for the primary endpoint for Q/LAIV was: H0: Rj \> 1.5, for any j HA: Rj ≤ 1.5, for all j Where Rj was any of the 4 strain-specific post immunogenicity dose GMT ratios: (FluMist/B/Yamagata) / (Q/LAIV) for B/Yamagata strain||1.37|1.07|
71086781|NCT01091246|141679191|NON_INFERIORITY_OR_EQUIVALENCE|The noninferior immune response was assessed by evaluating the upper bound of the two-sided 95% confidence intervals for the strain specific HAI antibody GMT ratios (FluMist divided by Q/LAIV) to the noninferiority margin of 1.5. If the upper bounds of 95% confidence intervals were ≤ 1.5 for all 4 strains, the immunologic noninferiority of Q/LAIV compared to FluMist was declared.|Ratio of geometric mean|1.05|||||TWO_SIDED|95.0|0.93|1.18||||||B/Victoria: The statistical hypothesis testing for the primary endpoint for Q/LAIV was: H0: Rj \> 1.5, for any j HA: Rj ≤ 1.5, for all j Where Rj was any of the 4 strain-specific post immunogenicity dose GMT ratios: (FluMist/B/Victoria) / (Q/LAIV) for B/Victoria strain||1.18|0.93|
71086782|NCT02731300|141679227|SUPERIORITY_OR_OTHER||||||<|0.05||||||the final Week 4 values compared between active tDCS and sham tDCS groups|ANOVA|||the final Week 4 values compared between active tDCS and sham tDCS groups||||<0.05
71086783|NCT02731300|141679228|SUPERIORITY_OR_OTHER||||||<|0.05||||||the final Week 4 values compared between active tDCS and sham tDCS groups|ANOVA|||the final Week 4 values compared between active tDCS and sham tDCS groups||||<0.05
71086784|NCT02713178|141679229|SUPERIORITY||LSMD|-20.249||||0.4463|TWO_SIDED|95.0|-72.361|31.864|||ANOVA|||||31.864|-72.361|0.4463
71086785|NCT02713178|141679229|SUPERIORITY||LSMD|-28.796||||0.2749|TWO_SIDED|95.0|-80.483|22.892|||ANOVA|||||22.892|-80.483|0.2749
71086786|NCT02713178|141679230|SUPERIORITY||LSM treatment ratio|0.853||||0.0716|TWO_SIDED|95.0|0.717|1.014|||ANOVA|||||1.014|0.717|0.0716
71086787|NCT02713178|141679230|SUPERIORITY||LSM treatment ratio|0.913||||0.3004|TWO_SIDED|95.0|0.769|1.084|||ANOVA|||||1.084|0.769|0.3004
71086788|NCT02713178|141679232|SUPERIORITY|||||||0.1896|||||||Log Rank|||The overall distribution as estimated by the Kaplan-Meier analysis was compared between the EXPAREL arm and the placebo arm.||||0.1896
71086789|NCT02713178|141679232|SUPERIORITY|||||||0.2549|||||||Log Rank|||The overall distribution as estimated by the Kaplan-Meier analysis was compared between the EXPAREL arm and the placebo arm.||||0.2549
71086790|NCT00596271|141679237|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority of the combined administration is postulated, if the lower bounds of both twosided 95% confidence intervals for the GMT ratios (of combined vaccination over single vaccination) are \> 1/2.~This procedure is equivalent to the approach based on a 1-sided test with a significance level of 2.5% for each comparison with the null hypothesis H0 : ratio ≤ 0.5 versus the alternative hypotheses H1 : ratio \> 0.5."|||||<|0.0001||95.0|||||ANOVA|||The primary efficacy analysis will compare the IC51+HAVRIX vs. IC51+Placebo group in terms of the GMT for anti- JEV neutralizing antibody at day 56. An observed cases approach will be applied for the primary analysis||||<0.0001
71086791|NCT00596271|141679241|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority of the combined administration is postulated, if the lower bounds of both twosided 95% confidence intervals for the GMT ratios (of combined vaccination over single vaccination) are \> 1/2.~This procedure is equivalent to the approach based on a 1-sided test with a significance level of 2.5% for each comparison with the null hypothesis H0 : ratio ≤ 0.5 versus the alternative hypotheses H1 : ratio \> 0.5."|||||<|0.0001||95.0|||||ANOVA|||The primary efficacy analysis will compare the IC51+HAVRIX vs. HAVRIX+Placebo group in terms of the GMT for HAV antibody at day 28. An observed cases approach will be applied for the primary analysis.||||<0.0001
71086792|NCT00689338|141679292|SUPERIORITY_OR_OTHER||estimate of survival|53.8|||||TWO_SIDED|95.0|45.9|60.9|||Kaplan-Meier|||Kaplan-Meier estimate of survival at Day 90 (survivor function).||60.9|45.9|
71086793|NCT00078286|141679351|NON_INFERIORITY_OR_EQUIVALENCE|\*Power analysis already provided.|Difference in mean change score|-0.3||||0.89||95.0|||||Mixed Models Analysis|Significance was tested at p=.05.||A hierarchical mixed model was used, analyzing the fixed effects of treatment, the natural log of time, natural log of time squared, the interactions of time and time squared with treatment and site, as well as the random effects of patient, patient-by-time, and square of patient-by-time.||||0.89
71086794|NCT00078286|141679352|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.08||||0.78||95.0|||||Cochran-Mantel-Haenszel|||Tests for differences of proportions were used to examine the composite cardiovascular status outcome at the end of acute treatment. Chi-square tests were used to test for overall treatment differences, with a Mantel Haenszel test performed to examine treatment differences when controlling for clinical site. The primary analyses were conducted on the tri-level cardiovascular status outcome.||||.78
71086795|NCT02668640|141679359|OTHER||||||=|0.0002|||||||Wilcoxon signed-rank test|||||||=0.0002
71086796|NCT02668640|141679360|OTHER||||||=|0.0006|||||||Wilcoxon signed-rank test|||||||=0.0006
71086797|NCT02668640|141679361|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||Median change from baseline in PCS T-score at Week 12||||<0.0001
71086798|NCT02668640|141679361|OTHER||||||=|0.1233|||||||Wilcoxon signed-rank test|||Median change from baseline in MCS T-score at Week 12||||=0.1233
71086799|NCT02668640|141679361|OTHER||||||<|0.001|||||||Wilcoxon signed-rank test|||Median change from baseline in PCS T-score at Week 24||||<0.001
71086800|NCT02668640|141679361|OTHER||||||=|0.001|||||||Wilcoxon signed-rank test|||Median change from baseline in MCS T-score at Week 24||||=0.001
71086801|NCT02668640|141679362|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||Median Change From Baseline in EQ-5D-3L Index Score at Week 12||||<0.0001
71086802|NCT02668640|141679362|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||Median Change From Baseline in EQ-5D-3L Index Score at Week 24||||<0.0001
71086803|NCT02668640|141679363|OTHER||||||=|0.0137|||||||Wilcoxon signed-rank test|||Median Change from Baseline in WPAI Overall Work Impairment Score at Week 12||||=0.0137
71086804|NCT02668640|141679363|OTHER||||||=|0.0607|||||||Wilcoxon signed-rank test|||Median Change from Baseline in Overall Work Impairment Score at Week 24||||=0.0607
71086805|NCT02668640|141679364|OTHER||||||=|0.0026|||||||Wilcoxon signed-rank test|||Median Change from Baseline in WPAI Activity Impairment Score at Week 12||||=0.0026
71086806|NCT02668640|141679364|OTHER||||||=|0.0001|||||||Wilcoxon signed-rank test|||Median Change from Baseline in WPAI Activity Impairment Score at Week 24||||=0.0001
71086807|NCT03669588|141679367|SUPERIORITY||Odds Ratio (OR)|4.951|||<|0.0001|TWO_SIDED|95.0|2.213|11.528|||Regression, Logistic|||"Analysis with a 2-sided exact test (using logistic regression) at the 2-sided 5% significance level in the AChR-Ab seropositive population, stratified by Japanese versus (vs) non-Japanese and NSID vs no NSID as concomitant gMG treatment, with cycle baseline MG-ADL total score as covariate.~The treatment effect was presented as the odds ratio. An odds ratio of more than 1 represents a higher response rate for ARGX-113 compared to placebo."||11.528|2.213|<0.0001
71086808|NCT03669588|141679368|SUPERIORITY||Odds Ratio (OR)|10.842|||<|0.0001|TWO_SIDED|95.0|4.179|31.2|||Regression, Logistic|||"Analysis with a 2-sided exact test (using logistic regression) at the 2-sided 5% significance level in the AChR-Ab seropositive population, stratified by Japanese vs non-Japanese and NSID vs no NSID as concomitant gMG treatment, with cycle baseline QMG total score as covariate.~The treatment effect was presented as the odds ratio. An odds ratio of more than 1 represents a higher response rate for ARGX-113 compared to placebo."||31.200|4.179|<0.0001
71086809|NCT03669588|141679369|SUPERIORITY||Odds Ratio (OR)|3.699|||<|0.0001|TWO_SIDED|95.0|1.854|7.578|||Regression, Logistic|||"Analysis with a 2-sided exact test (using logistic regression) at the 2-sided 5% significance level in the overall population, stratified by AChR-Ab status (seropositive vs seronegative), Japanese vs non-Japanese and NSID vs no NSID as concomitant gMG treatment, with cycle baseline MG-ADL total score as covariate.~The treatment effect was presented as the odds ratio. An odds ratio of more than 1 represents a higher response rate for ARGX-113 compared to placebo."||7.578|1.854|<0.0001
71086810|NCT03669588|141679370|SUPERIORITY||Least square means difference|22.065|STANDARD_ERROR_OF_MEAN|5.616||0.0001|TWO_SIDED|95.0|10.949|33.181|||ANCOVA|||Analysis of covariance (ANCOVA) in the AChR-Ab seropositive population with treatment, baseline MG-ADL total score, Japanese vs non-Japanese, and NSID vs no NSID as concomitant gMG treatment as the covariates.||33.181|10.949|0.0001
71086811|NCT03669588|141679371|SUPERIORITY|||||||0.2604|||||||Log Rank|||Analysis was performed in the AChR-Ab seropositive population and the p-value was calculated using the log-rank test, stratified by Japanese vs non-Japanese and NSID vs no NSID as concomitant gMG treatment.||||0.2604
71086812|NCT00369343|141679373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.32|||<|0.001||95.0|2.53|6.11|||Mixed Models Analysis|Mixed Models Repeated Measures (MMRM) used baseline as a covariate and factors for center, week and treatment.|DVS SR adjusted mean change minus placebo adjusted mean change.|||6.11|2.53|<0.001
71086813|NCT00369343|141679374|SUPERIORITY_OR_OTHER||||||<|0.001||||||DVS SR compared to Placebo for CGI-I scores of either 1 (very much improved) or 2 (much improved).|Cochran-Mantel-Haenszel|||||||<0.001
71086814|NCT00369343|141679375|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.132||||0.008||95.0|1.22|3.74||DVS SR compared with Placebo.|Chi-squared|Logistic regression model with treatment and site as factors and baseline score as a covariate.|Adjusted odds ratio of DVS SR to Placebo. Odds ratio adjusted for baseline, treatment and site.|||3.74|1.22|0.008
70945320|NCT01475461|141391152|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.07|STANDARD_ERROR_OF_MEAN|5.785||0.3604|TWO_SIDED|80.0|-9.5|5.36||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||5.36|-9.50|0.3604
71086815|NCT00369343|141679376|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.125|||<|0.001||95.0|1.85|5.27||DVS SR compared with Placebo.|Chi-squared|Logistic regression model with treatment and site as factors and baseline score as a covariate.|Adjusted odds ratio of DVS SR to Placebo. Odd ratio adjusted for baseline, treatment and site.|||5.27|1.85|<0.001
71086816|NCT00369343|141679377|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.74|||<|0.001||95.0|1.24|4.23||Mixed model Repeated Measures (MMRM) analysis adjusted mean score for baseline score, time and center.|Mixed Models Analysis||Adjusted mean difference = Placebo adjusted mean score minus DVS SR adjusted mean score.|||4.23|1.24|<0.001
71086817|NCT00369343|141679378|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12|||<|0.001||95.0|-0.18|-0.06||Mixed Model Repeated Measures (MMRM) with treatment and site as factors and baseline as covariate.|Mixed Models Analysis||Adjusted mean difference = Placebo adjusted mean score minus DVS SR adjusted mean score.|||-0.06|-0.18|<0.001
71086818|NCT00369343|141679385|SUPERIORITY_OR_OTHER|||||||0.553||||||t-test adjusted by multiple comparison|t-test, 2 sided|||100mg vs. Placebo (0mg) post taper||||0.553
71086819|NCT00369343|141679385|SUPERIORITY_OR_OTHER|||||||0.034||||||t-test adjusted by multiple comparison|t-test, 2 sided|||200mg vs. Placebo (0mg) post taper||||0.034
70945321|NCT01475461|141391152|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.12|STANDARD_ERROR_OF_MEAN|5.636||0.0161|TWO_SIDED|80.0|-19.36|-4.88||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-4.88|-19.36|0.0161
71086820|NCT01100502|141679386|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57||||0.001|TWO_SIDED|95.0|0.4|0.81|||Log Rank|||||0.81|0.40|0.001
71086821|NCT01409239|141679390|SUPERIORITY_OR_OTHER|||||||0.05||||||Wilcoxon rank-sum was used to determine differences between groups.|Wilcoxon (Mann-Whitney)|||Since this was a pilot study no formal power analysis was possible. It was hypothesized that IV insulin would be associated with lower LF/HF HRV.||||0.05
71086822|NCT01190813|141679392|SUPERIORITY_OR_OTHER||Percent Difference|11.0||||0.06|TWO_SIDED|95.0|-7.0|28.0|||Fisher Exact|It was not possible to adjust for baseline VA in these secondary analyses due to the small number of subjects meeting secondary outcome criteria.|Treatment group difference calculated as Levodopa - Placebo|A sample size of 129 participants provided 80% power with 1-sided type I error rate of 5% to reject the hypothesis of no difference between groups if the proportion improved was 30% in the levodopa group compared with 10% in the placebo group.||28|-7|0.06
71086823|NCT01190813|141679395|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-17.0|18.0|||||Levodopa - Placebo|||18|-17|
71086824|NCT01190813|141679396|SUPERIORITY_OR_OTHER||Percent Difference|-7.0|||||TWO_SIDED|95.0|-25.0|10.0||||||||10|-25|
71086825|NCT01190813|141679397|SUPERIORITY_OR_OTHER||Percent Difference|-5.0|||||TWO_SIDED|95.0|-22.0|13.0|||||Levodopa - Placebo|||13|-22|
71086826|NCT01190813|141679405|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.65|TWO_SIDED|95.0|-1.9|1.3|||ANCOVA||Mean difference calculated as Levodopa - Placebo|||1.3|-1.9|0.65
71086827|NCT01190813|141679407|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.44|TWO_SIDED|95.0|-1.6|1.8|||ANCOVA|||||1.8|-1.6|0.44
71086828|NCT01190813|141679409|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9||||0.2|TWO_SIDED|95.0|-1.2|2.9|||ANCOVA|||||2.9|-1.2|0.20
71086829|NCT01190813|141679411|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9||||0.17|TWO_SIDED||||||ANCOVA|||||||0.17
71124422|NCT05063539|141754927|SUPERIORITY||LS Mean Difference|-4.01|STANDARD_ERROR_OF_MEAN|1.13|<|0.001|TWO_SIDED|95.0|-6.239|-1.788|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||-1.788|-6.239|<0.001
71124423|NCT05063539|141754928|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.53||0.259|TWO_SIDED|95.0|-0.445|1.642|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||1.642|-0.445|0.259
71124424|NCT05063539|141754928|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.55||0.324|TWO_SIDED|95.0|-1.629|0.541|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||0.541|-1.629|0.324
71124425|NCT05063539|141754929|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.57||0.749|TWO_SIDED|95.0|-0.946|1.313|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||1.313|-0.946|0.749
71124426|NCT05063539|141754929|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.59||0.029|TWO_SIDED|95.0|-2.462|-0.134|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||-0.134|-2.462|0.029
71124427|NCT05063539|141754930|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.012||0.346|TWO_SIDED|95.0|-0.01|0.03|||ANCOVA|||Frontal||0.03|-0.01|0.346
71124428|NCT05063539|141754930|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.013||0.412|TWO_SIDED|95.0|-0.04|0.01|||ANCOVA|||Frontal||0.01|-0.04|0.412
71124429|NCT05063539|141754930|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.013||0.421|TWO_SIDED|95.0|-0.04|0.02|||ANCOVA|||Parietal||0.02|-0.04|0.421
71124430|NCT05063539|141754930|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.014||0.08|TWO_SIDED|95.0|-0.05|0.0|||ANCOVA|||Parietal||0.00|-0.05|0.080
71124431|NCT05063539|141754930|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.021||0.192|TWO_SIDED|95.0|-0.07|0.01|||ANCOVA|||Lateral occipital||0.01|-0.07|0.192
71124432|NCT05063539|141754930|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.022||0.279|TWO_SIDED|95.0|-0.07|0.02|||ANCOVA|||Lateral occipital||0.02|-0.07|0.279
71124433|NCT05063539|141754930|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.016||0.693|TWO_SIDED|95.0|-0.04|0.02|||ANCOVA|||Lateral temporal||0.02|-0.04|0.693
71124434|NCT05063539|141754930|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.016||0.04|TWO_SIDED|95.0|-0.07|0.0|||ANCOVA|||Lateral temporal||-0.00|-0.07|0.040
71124435|NCT05063539|141754930|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.015||0.838|TWO_SIDED|95.0|-0.03|0.03|||ANCOVA|||AD neocortical signature (measured using MUBADA)||0.03|-0.03|0.838
71124436|NCT05063539|141754930|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.016||0.055|TWO_SIDED|95.0|-0.06|0.0|||ANCOVA|||AD neocortical signature (measured using MUBADA)||0.00|-0.06|0.055
71124437|NCT05063539|141754931|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.013||0.455|TWO_SIDED|95.0|-0.02|0.04|||ANCOVA|||Frontal||0.04|-0.02|0.455
71124438|NCT05063539|141754931|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.014||0.745|TWO_SIDED|95.0|-0.03|0.02|||ANCOVA|||Frontal||0.02|-0.03|0.745
71124439|NCT05063539|141754931|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.015||0.676|TWO_SIDED|95.0|-0.02|0.04|||ANCOVA|||Parietal||0.04|-0.02|0.676
71124440|NCT05063539|141754931|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.015||0.794|TWO_SIDED|95.0|-0.03|0.03|||ANCOVA|||Parietal||0.03|-0.03|0.794
71124441|NCT05063539|141754931|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.021||0.643|TWO_SIDED|95.0|-0.05|0.03|||ANCOVA|||Lateral occipital||0.03|-0.05|0.643
71124442|NCT05063539|141754931|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.021||0.88|TWO_SIDED|95.0|-0.05|0.04|||ANCOVA|||Lateral occipital||0.04|-0.05|0.880
71124443|NCT05063539|141754931|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.017||0.844|TWO_SIDED|95.0|-0.04|0.03|||ANCOVA|||Lateral temporal||0.03|-0.04|0.844
71124444|NCT05063539|141754931|SUPERIORITY|Lateral temporal|LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.017||0.388|TWO_SIDED|95.0|-0.05|0.02|||ANCOVA|||||0.02|-0.05|0.388
71124445|NCT05063539|141754931|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.016||0.815|TWO_SIDED|95.0|-0.03|0.04|||ANCOVA|||AD neocortical signature (measured using MUBADA)||0.04|-0.03|0.815
71124446|NCT05063539|141754931|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.017||0.562|TWO_SIDED|95.0|-0.04|0.02|||ANCOVA|||AD neocortical signature (measured using MUBADA)||0.02|-0.04|0.562
71124447|NCT05063539|141754932|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.024|<|0.001|TWO_SIDED|95.0|0.04|0.14|||Mixed Models Analysis|||Bilateral Hippocampus||0.14|0.04|<0.001
71124448|NCT05063539|141754932|SUPERIORITY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.025|<|0.001|TWO_SIDED|95.0|0.08|0.18|||Mixed Models Analysis|||Bilateral Hippocampus||0.18|0.08|<0.001
71124449|NCT05063539|141754932|SUPERIORITY||LS Mean Difference|-2.37|STANDARD_ERROR_OF_MEAN|0.587|<|0.001|TWO_SIDED|95.0|-3.53|-1.21|||Mixed Models Analysis|||Bilateral Whole Lateral Ventricles||-1.21|-3.53|<0.001
71124450|NCT05063539|141754932|SUPERIORITY||LS Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.611||0.008|TWO_SIDED|95.0|-2.84|-0.43|||Mixed Models Analysis|||Bilateral Whole Lateral Ventricles||-0.43|-2.84|0.008
71124451|NCT05063539|141754932|SUPERIORITY||LS Mean Difference|8.17|STANDARD_ERROR_OF_MEAN|1.715|<|0.001|TWO_SIDED|95.0|4.79|11.56|||Mixed Models Analysis|||Bilateral Whole Brain||11.56|4.79|<0.001
71124452|NCT05063539|141754932|SUPERIORITY||LS Mean Difference|9.37|STANDARD_ERROR_OF_MEAN|1.804|<|0.001|TWO_SIDED|95.0|5.81|12.92|||Mixed Models Analysis|||Bilateral Whole Brain||12.92|5.81|<0.001
71124453|NCT05063539|141754933|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.023|<|0.001|TWO_SIDED|95.0|0.04|0.13|||Mixed Models Analysis|||Bilateral Hippocampus||0.13|0.04|<0.001
71124454|NCT05063539|141754933|SUPERIORITY|Bilateral Hippocampus|LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.023|<|0.001|TWO_SIDED|95.0|0.08|0.17|||Mixed Models Analysis|||||0.17|0.08|<0.001
71124455|NCT05063539|141754933|SUPERIORITY||LS Mean Difference|-2.21|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|95.0|-3.33|-1.08|||Mixed Models Analysis|||Bilateral Whole Lateral Ventricles||-1.08|-3.33|<0.001
71124456|NCT05063539|141754933|SUPERIORITY||LS Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|0.582||0.015|TWO_SIDED|95.0|-2.57|-0.28|||Mixed Models Analysis|||Bilateral Whole Lateral Ventricles||-0.28|-2.57|0.015
71124457|NCT05063539|141754933|SUPERIORITY||LS Mean Difference|7.17|STANDARD_ERROR_OF_MEAN|1.635|<|0.001|TWO_SIDED|95.0|3.95|10.4|||Mixed Models Analysis|||Bilateral Whole Brain||10.40|3.95|<0.001
71124458|NCT05063539|141754933|SUPERIORITY||LS Mean Difference|8.16|STANDARD_ERROR_OF_MEAN|1.68|<|0.001|TWO_SIDED|95.0|4.85|11.47|||Mixed Models Analysis|||Bilateral Whole Brain||11.47|4.85|<0.001
71124459|NCT00300677|141754940|SUPERIORITY_OR_OTHER||predose: ratio adjusted geometric means|300.28||||||90.0|192.91|467.43|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole.|Other estimated parameter represents the Day 3 pre-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||467.43|192.91|
71124460|NCT00300677|141754940|SUPERIORITY_OR_OTHER||postdose: ratio adjusted geometric means|192.72||||||90.0|123.81|300.0|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole.|Other estimated parameter represents the Day 3 post-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||300.00|123.81|
71124461|NCT00300677|141754941|SUPERIORITY_OR_OTHER||predose: ratio adjusted geometric means|300.28||||||90.0|192.91|467.43|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of the adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole.|Other estimated parameter represents the Day 3 pre-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||467.43|192.91|
70945322|NCT01475461|141391152|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.41|STANDARD_ERROR_OF_MEAN|5.663||0.2185|TWO_SIDED|80.0|-11.68|2.87||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.87|-11.68|0.2185
70856959|NCT02446743|141200497|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group ratio of GMTs|16.0|||||TWO_SIDED|95.0|12.0|21.0|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||21|12|
71124462|NCT00300677|141754941|SUPERIORITY_OR_OTHER||postdose: ratio adjusted geometric means|192.72||||||90.0|123.81|300.0|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole.|Other estimated parameter represents the Day 3 post-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||300.00|123.81|
71124463|NCT00300677|141754942|SUPERIORITY_OR_OTHER||predose: ratio adjusted geometric means|12.39||||||90.0|7.09|21.65|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole N-oxide.|Other estimated parameter represents the Day 3 pre-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole N-oxide. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||21.65|7.09|
71124464|NCT00300677|141754942|SUPERIORITY_OR_OTHER||postdose: ratio adjusted geometric means|31.57||||||90.0|18.06|55.18|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole N-oxide.|Other estimated parameter represents the Day 3 post-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole N-oxide. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||55.18|18.06|
71124465|NCT00300677|141754943|SUPERIORITY_OR_OTHER||predose: ratio adjusted mean|12.39||||||90.0|7.09|21.65|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plama (reference) concentrations of voriconazole N-oxide.|Other estimated parameter represents the Day 3 pre-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole N-oxide. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||21.65|7.09|
71124466|NCT00300677|141754943|SUPERIORITY_OR_OTHER||postdose: ratio adjusted mean|31.57||||||90.0|18.06|55.18|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole N-oxide.|Other estimated parameter represents the Day 3 post-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole N-oxide. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||55.18|18.06|
71124467|NCT00443781|141754951|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||McNemar|Exact test was used.||Mcnemar test was used to test the difference between paired PD (provocative discography) and F.A.D. (Functional Anesthetic Discography) proportions.||||0.002
71124468|NCT00364533|141754963|SUPERIORITY_OR_OTHER||LS mean difference of SPID48|91.4|||<|0.001||95.0|49.77|133.07|||ANCOVA|||The study was terminated and did not reach the planned sample size.||133.07|49.77|<0.001
71124469|NCT00364533|141754963|SUPERIORITY_OR_OTHER||LS mean difference of SPID48|81.5|||<|0.001||95.0|38.66|124.29|||ANCOVA|||The study was terminated and did not reach the planned sample size.||124.29|38.66|<0.001
71124470|NCT00364533|141754963|SUPERIORITY_OR_OTHER||LS mean difference of SPID48|81.5|||<|0.001||95.0|39.21|123.8|||ANCOVA|||The study was terminated and did not reach the planned sample size.||123.80|39.21|<0.001
71124471|NCT00364533|141754963|SUPERIORITY_OR_OTHER||LS mean difference of SPID48|82.4|||<|0.001||95.0|38.96|125.88|||ANCOVA|||The study was terminated and did not reach the planned sample size.||125.88|38.96|<0.001
71086830|NCT01190813|141679415|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4||||0.06|TWO_SIDED|95.0|-0.4|3.3||The alpha level was set to 0.0485 for the primary analysis to adjust for alpha spending of 0.015 for one interim analysis for efficacy conducted when outcome data were available for 50% of participants.|ANCOVA||Mean difference calculated as Levodopa - Placebo|With 129 participants, assuming a 1-sided type I error rate of 4.85%, there was 96% power to detect a difference in mean visual acuity between treatment groups at 18 weeks adjusted for baseline and for 1 interim analysis for futility if the true difference was 5 letters with SD of 7 letters and 82% power if the true difference was 3.75 letters||3.3|-0.4|0.06
70856960|NCT02446743|141200497|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|vaccine group ratio of GMTs|20.0|||||TWO_SIDED|95.0|14.0|28.0|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||28|14|
71086831|NCT01386606|141679453|SUPERIORITY_OR_OTHER|||||||0.056|TWO_SIDED|||||P-value of treatment group.|Regression, Linear|||"Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group."||||0.056
71124472|NCT01943552|141754973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|154.9|STANDARD_ERROR_OF_MEAN|32.32|<|0.0001|TWO_SIDED|95.0|91.08|218.63|||ANCOVA||The Mean Difference; nebulized ipratropium minus placebo was estimated by the difference of their adjusted means.|The analysis of covariance (ANCOVA) method was used to compare the change of FEV1 from pre-bronchodilator at baseline to post-nebulization on treatment day 3 between the active arm and the placebo arm, with baseline value as covariate and two stratification factors based on acute bronchodilator responsiveness at baseline and age as main effects.||218.63|91.08|<0.0001
71124473|NCT01943552|141754974|SUPERIORITY_OR_OTHER||Mean Difference (Net)|51.0|STANDARD_ERROR_OF_MEAN|54.48||0.3509|TWO_SIDED|95.0|-56.55|158.46|||ANCOVA||The Mean Difference; nebulized ipratropium minus placebo was estimated by the difference of their adjusted means.|The analysis of covariance (ANCOVA) method was used to compare the change of forced vital capacity (FVC) from pre-bronchodilator at baseline to post-nebulization on treatment day 3 between the active arm and the placebo arm, with baseline value as covariate and two stratification factors based on acute bronchodilator responsiveness at baseline and age as main effects.||158.46|-56.55|0.3509
71124474|NCT01943552|141754975|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.8|STANDARD_ERROR_OF_MEAN|2.18||0.2069|TWO_SIDED|95.0|-1.54|7.07|||ANCOVA||The Mean Difference; nebulized ipratropium minus placebo was estimated by the difference of their adjusted means.|The analysis of covariance (ANCOVA) method was used to compare the change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization on treatment day 3 for PaO2 between the active arm and the placebo arm, with baseline value as covariate and two stratification factors based on acute bronchodilator responsiveness at baseline and age as main effects.||7.07|-1.54|0.2069
71124475|NCT01943552|141754976|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.28||0.1899|TWO_SIDED|95.0|-0.19|0.93|||ANCOVA||The Mean Difference; nebulized ipratropium minus placebo was estimated by the difference of their adjusted means.|The analysis of covariance (ANCOVA) method was used to compare the change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization on treatment day 3 for Oxygen saturation between the active arm and the placebo arm, with baseline value as covariate and two stratification factors based on acute bronchodilator responsiveness at baseline and age as main effects.||0.93|-0.19|0.1899
71124476|NCT01943552|141754977|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.57||0.4758|TWO_SIDED|95.0|-0.72|1.55|||ANCOVA||The Mean Difference; nebulized ipratropium minus placebo was estimated by the difference of their adjusted means.|The analysis of covariance (ANCOVA) method was used to compare the change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization on treatment day 3 for PaCO2 between the active arm and the placebo arm, with baseline value as covariate and two stratification factors based on acute bronchodilator responsiveness at baseline and age as main effects.||1.55|-0.72|0.4758
71124477|NCT01943552|141754978|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel Test Statistic|1.82||||0.1779|TWO_SIDED||||||Cochran-Mantel-Haenszel|||For main post-operative pulmonary complications, the Cochran-Mantel-Haenszel analysis was performed on the SCS. Mantel-Haenszel test with strata based on acute bronchodilator responsiveness at baseline and age was used to compare the number of patients with main post-operative pulmonary complications between the two arms.||||0.1779
71124478|NCT00576472|141754992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.033|STANDARD_ERROR_OF_MEAN|0.0062|<|0.0001|TWO_SIDED|95.0|-0.0452|-0.0208|||ANOVA|||||-0.0208|-0.0452|<.0001
71124479|NCT00576472|141754993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0285|STANDARD_ERROR_OF_MEAN|0.0046|<|0.0001|TWO_SIDED|95.0|0.019|0.038|||ANOVA|||||0.0380|0.0190|<.0001
71124480|NCT00576472|141754994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0144|STANDARD_ERROR_OF_MEAN|0.0064||0.025|TWO_SIDED|95.0|0.000204|0.0285|||ANOVA|||||0.0285|0.000204|0.025
71124481|NCT00576472|141754994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0442|STANDARD_ERROR_OF_MEAN|0.0093|<|0.0001|TWO_SIDED|95.0|0.0292|0.0591|||ANOVA|||||0.0591|0.0292|<.0001
71124482|NCT00576472|141754994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0491|STANDARD_ERROR_OF_MEAN|0.0064|<|0.0001|TWO_SIDED|95.0|0.0396|0.0586|||ANOVA|||||0.0586|0.0396|<.0001
71124483|NCT00576472|141754994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0298|STANDARD_ERROR_OF_MEAN|0.0083||0.0004|TWO_SIDED|95.0|0.00974|0.0499|||ANOVA|||||0.0499|0.00974|.0004
71086832|NCT01386606|141679453|SUPERIORITY_OR_OTHER||Regression Coefficient|-45.77||||0.436|TWO_SIDED|95.0|-143.5|51.98||P-value for Androxal 25 mg treatment group.|Regression, Linear|||"Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group."||51.98|-143.5|0.436
71124484|NCT00576472|141754994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0347|STANDARD_ERROR_OF_MEAN|0.0047|<|0.0001|TWO_SIDED|95.0|0.025|0.0445|||ANOVA|||||0.0445|0.0250|<.0001
71124485|NCT00576472|141754994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.00494|STANDARD_ERROR_OF_MEAN|0.0083||0.552|TWO_SIDED|95.0|-0.00865|0.0185|||ANOVA|||||0.0185|-0.00865|.552
71124486|NCT00576472|141754995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.17|STANDARD_ERROR_OF_MEAN|1.93||0.0005|TWO_SIDED|95.0|-11.0|-3.3|||ANOVA|||||-3.3|-11.0|.0005
71086833|NCT01386606|141679453|SUPERIORITY_OR_OTHER||Regression Coefficient|-110.9||||0.068|TWO_SIDED|95.0|-210.6|-11.23||P-value for Androxal 12.5 mg group.|Regression, Linear|||"Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group."||-11.23|-210.6|0.068
71086834|NCT01386606|141679453|SUPERIORITY_OR_OTHER||Regression Coefficient|-148.5||||0.011|TWO_SIDED|95.0|-242.9|-54.05||P-value for Androxal 6.25 mg group.|Regression, Linear|||"Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group."||-54.05|-242.9|0.011
71124487|NCT00576472|141754996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.34|STANDARD_ERROR_OF_MEAN|1.59||0.0413|TWO_SIDED|95.0|-6.5|-0.1|||ANOVA|||||-0.1|-6.5|0.0413
71124488|NCT00576472|141754997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.74|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|-11.0|-6.4|||ANOVA|||||-6.4|-11.0|<.0001
71124489|NCT00576472|141754998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.56|STANDARD_ERROR_OF_MEAN|1.3|<|0.0001|TWO_SIDED|95.0|-12.0|-7.0|||ANOVA|||||-7.0|-12.0|<.0001
71124490|NCT00576472|141754999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.99|STANDARD_ERROR_OF_MEAN|1.81|<|0.0001|TWO_SIDED|95.0|4.4|11.6|||ANOVA|||||11.6|4.4|<.0001
71124491|NCT00576472|141755000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|1.03||0.8425|TWO_SIDED|95.0|-2.3|1.9|||ANOVA|||||1.9|-2.3|.8425
71124492|NCT00576472|141755001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.41|STANDARD_ERROR_OF_MEAN|0.73||0.0016|TWO_SIDED|95.0|-3.9|-0.9|||ANOVA|||||-0.9|-3.9|.0016
71124493|NCT00576472|141755002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|1.04||0.8329|TWO_SIDED|95.0|-1.9|2.3|||ANOVA|||||2.3|-1.9|.8329
71124494|NCT00576472|141755004|SUPERIORITY_OR_OTHER|||||||0.0077||95.0|||||t-test, 2 sided|||||||0.0077
71124495|NCT00576472|141755004|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
71124496|NCT00576472|141755004|SUPERIORITY_OR_OTHER|||||||0.1408||95.0|||||t-test, 2 sided|||||||0.1408
71124497|NCT00576472|141755005|SUPERIORITY_OR_OTHER|||||||0.0428||95.0|||||t-test, 2 sided|||||||0.0428
71124498|NCT00576472|141755005|SUPERIORITY_OR_OTHER|||||||0.0058||95.0|||||t-test, 2 sided|||||||0.0058
71086835|NCT01386606|141679453|SUPERIORITY_OR_OTHER||Regression Coefficient|0.58|||<|0.001|TWO_SIDED|95.0|0.37|0.79||P-value for morning total testosterone (adjusted for treatment effect if treatment group is significant).|Regression, Linear|||"Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group."||0.79|0.37|<0.001
71086836|NCT01386606|141679454|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning LH at Week 2. Modeling change from baseline by treatment group.||||<0.001
71086837|NCT01386606|141679454|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning LH at Week 4. Modeling change from baseline by treatment group.||||<0.001
71086838|NCT01386606|141679454|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning LH at Week 6. Modeling change from baseline by treatment group.||||<0.001
71086839|NCT01386606|141679455|SUPERIORITY_OR_OTHER||Pearson Correlation|0.90993|||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Pearson correlation between 9 am morning testosterone and serial testosterone Cavg at Week 6.||||<0.0001
71124499|NCT00576472|141755005|SUPERIORITY_OR_OTHER|||||||0.4258||95.0|||||t-test, 2 sided|||||||0.4258
71124500|NCT00576472|141755006|SUPERIORITY_OR_OTHER|||||||0.0035||95.0|||||t-test, 2 sided|||||||0.0035
71124501|NCT00576472|141755006|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||t-test, 2 sided|||||||0.0003
71124502|NCT00576472|141755006|SUPERIORITY_OR_OTHER|||||||0.4086||95.0|||||t-test, 2 sided|||||||0.4086
71124503|NCT00576472|141755007|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||t-test, 2 sided|||||||0.0001
71124504|NCT00576472|141755007|SUPERIORITY_OR_OTHER|||||||0.0007||95.0|||||t-test, 2 sided|||||||0.0007
71124505|NCT00576472|141755007|SUPERIORITY_OR_OTHER|||||||0.7007||95.0|||||t-test, 2 sided|||||||0.7007
71124506|NCT00576472|141755008|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||t-test, 2 sided|||||||0.0002
71124507|NCT00576472|141755008|SUPERIORITY_OR_OTHER|||||||0.0016||95.0|||||t-test, 2 sided|||||||0.0016
71124508|NCT00576472|141755008|SUPERIORITY_OR_OTHER|||||||0.6237||95.0|||||t-test, 2 sided|||||||0.6237
71124509|NCT00576472|141755009|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||t-test, 2 sided|||||||0.0002
71124510|NCT00576472|141755009|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<.0001
71124511|NCT00576472|141755009|SUPERIORITY_OR_OTHER|||||||0.6071||95.0|||||t-test, 2 sided|||||||0.6071
71124512|NCT00576472|141755010|SUPERIORITY_OR_OTHER|||||||0.1386||95.0|||||t-test, 2 sided|||||||0.1386
71124513|NCT00576472|141755010|SUPERIORITY_OR_OTHER|||||||0.0905||95.0|||||t-test, 2 sided|||||||0.0905
71124514|NCT00576472|141755010|SUPERIORITY_OR_OTHER|||||||0.8039||95.0|||||t-test, 2 sided|||||||0.8039
71124515|NCT00576472|141755011|SUPERIORITY_OR_OTHER|||||||0.7496||95.0|||||t-test, 2 sided|||||||0.7496
71124516|NCT00576472|141755011|SUPERIORITY_OR_OTHER|||||||0.9489||95.0|||||t-test, 2 sided|||||||0.9489
71124517|NCT00576472|141755011|SUPERIORITY_OR_OTHER|||||||0.7021||95.0|||||t-test, 2 sided|||||||0.7021
71124518|NCT00576472|141755012|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||t-test, 2 sided|||||||0.0190
71124519|NCT00576472|141755012|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||t-test, 2 sided|||||||0.0003
71124520|NCT00576472|141755012|SUPERIORITY_OR_OTHER|||||||0.1622||95.0|||||t-test, 2 sided|||||||0.1622
71124521|NCT00576472|141755013|SUPERIORITY_OR_OTHER|||||||0.1202||95.0|||||t-test, 2 sided|||||||0.1202
71124522|NCT00576472|141755013|SUPERIORITY_OR_OTHER|||||||0.0103||95.0|||||t-test, 2 sided|||||||0.0103
71124523|NCT00576472|141755013|SUPERIORITY_OR_OTHER|||||||0.2831||95.0|||||t-test, 2 sided|||||||0.2831
71124524|NCT00576472|141755014|SUPERIORITY_OR_OTHER|||||||0.7027||95.0|||||t-test, 2 sided|||||||0.7027
71124525|NCT00576472|141755015|SUPERIORITY_OR_OTHER|||||||0.7493||95.0|||||t-test, 2 sided|||||||0.7493
71124526|NCT00576472|141755016|SUPERIORITY_OR_OTHER|||||||0.7339||95.0|||||t-test, 2 sided|||||||0.7339
71124527|NCT00576472|141755017|SUPERIORITY_OR_OTHER|||||||0.6148||95.0|||||t-test, 2 sided|||||||0.6148
70945323|NCT01475461|141391152|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.41|STANDARD_ERROR_OF_MEAN|5.649||0.0034|TWO_SIDED|80.0|-22.67|-8.16||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-8.16|-22.67|0.0034
71086840|NCT01386606|141679455|SUPERIORITY_OR_OTHER||Pearson Correlation|0.86541|||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Pearson correlation between 9 am morning testosterone and serial testosterone Cmin at Week 6.||||<0.0001
71086841|NCT01386606|141679455|SUPERIORITY_OR_OTHER||Pearson Correlation|0.89643|||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Pearson correlation between 9 am morning testosterone and serial testosterone Cmax at Week 6.||||<0.0001
71086842|NCT01386606|141679457|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning FSH at Week 2. Modeling change from baseline by treatment group.||||<0.001
71086843|NCT01386606|141679457|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning FSH at Week 4. Modeling change from baseline by treatment group.||||<0.001
71086844|NCT01386606|141679457|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning FSH at Week 6. Modeling change from baseline by treatment group.||||<0.001
71086845|NCT03246347|141679461|SUPERIORITY||Proportion|0.6111|||<|0.001|TWO_SIDED|95.0|0.4346|0.7686|||One-sided test for binomial proportions|||The 12-month PSA CR rate with ADT + docetaxel is 27.7% (Sweeney 2015); we estimated that the lower limit of the 95% CI was 23.4%. We sought to test the null hypothesis that the 52-week PSA CR rate for subjects treated with study therapy was \<=25%. We anticipated enrolling 39 subjects and this design would provide 90% power with a 1-sided alpha =0.10 significance level, assuming the true 52-week PSA CR rate was 45%. An improvement from 25% to 45% in 52-week PSA CR rate was considered important.||.7686|.4346|<0.001
71086846|NCT01022203|141679470|SUPERIORITY_OR_OTHER||Slope|0.0001|||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||Used Intent to Treat Analysis. General linear mixed models (GLMMs) with main effects of treatment (SAT and PFE), time (baseline, end of treatment, and 12 week follow-up), and treatment by time interactions to model the longitudinal trajectories of the outcomes, for veterans and their partners. Time was flexibly modeled. All available observations from each subject were utilized in the GLMM modeling.||||<0.0001
71086847|NCT01022203|141679471|SUPERIORITY_OR_OTHER||Slope|0.004|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Used Intent to Treat Analysis. General linear mixed models (GLMMs) with main effects of treatment (SAT and PFE), time (baseline, end of treatment, and 12 week follow-up), and treatment by time interactions to model the longitudinal trajectories of the outcomes for veterans. Time was flexibly modeled. All available observations from each subject were utilized in the GLMM modeling.||||<0.001
71086848|NCT01022203|141679472|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||General linear mixed models with main effects of treatment, time (baseline, end of treatment, and 12 week follow-up), and treatment by time interactions as described for previous analyses.||||<0.0001
71086849|NCT03205150|141679511|SUPERIORITY||Mean Difference (Net)|-13.29|STANDARD_ERROR_OF_MEAN|7.35||0.075|TWO_SIDED|80.0|-22.8|-3.78|||ANCOVA|||||-3.78|-22.80|0.075
71086850|NCT03205150|141679511|SUPERIORITY||Mean Difference (Net)|-21.64|STANDARD_ERROR_OF_MEAN|7.49||0.005|TWO_SIDED|80.0|-31.33|-11.94|||ANCOVA|||||-11.94|-31.33|0.005
71086851|NCT03205150|141679511|SUPERIORITY||Mean Difference (Net)|8.35|STANDARD_ERROR_OF_MEAN|6.14||0.178|TWO_SIDED|80.0|0.41|16.29|||ANCOVA|||||16.29|0.41|0.178
71086852|NCT03205150|141679512|SUPERIORITY||Mean Difference (Net)|-1.73|STANDARD_ERROR_OF_MEAN|1.45||0.235|TWO_SIDED|80.0|-3.6|0.14|||ANCOVA|||||0.14|-3.60|0.235
71086853|NCT03205150|141679512|SUPERIORITY||Mean Difference (Net)|-4.26|STANDARD_ERROR_OF_MEAN|1.46||0.004|TWO_SIDED|80.0|-6.14|-2.37|||ANCOVA|||||-2.37|-6.14|0.004
71086854|NCT03205150|141679512|SUPERIORITY||Mean Difference (Net)|2.52|STANDARD_ERROR_OF_MEAN|1.19||0.037|TWO_SIDED|80.0|0.98|4.07|||ANCOVA|||||4.07|0.98|0.037
71086855|NCT03205150|141679513|SUPERIORITY||Mean Difference (Net)|-3.15|STANDARD_ERROR_OF_MEAN|0.83|<|0.001|TWO_SIDED|80.0|-4.22|-2.08|||ANCOVA|||||-2.08|-4.22|<.001
71086856|NCT03205150|141679513|SUPERIORITY||Mean Difference (Net)|-4.18|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|80.0|-5.28|-3.08|||ANCOVA|||||-3.08|-5.28|<.001
71086857|NCT03205150|141679513|SUPERIORITY||Mean Difference (Net)|1.03|STANDARD_ERROR_OF_MEAN|0.71||0.148|TWO_SIDED|80.0|0.12|1.94|||ANCOVA|||||1.94|0.12|0.148
71086858|NCT03205150|141679521|SUPERIORITY||Mean Difference (Net)|-11.15|STANDARD_ERROR_OF_MEAN|4.36||0.013|TWO_SIDED|80.0|-16.79|-5.5|||ANCOVA|||||-5.50|-16.79|0.013
71086859|NCT03205150|141679521|SUPERIORITY||Mean Difference (Net)|-14.71|STANDARD_ERROR_OF_MEAN|4.43||0.001|TWO_SIDED|80.0|-20.43|-8.98|||ANCOVA|||||-8.98|-20.43|0.001
71124528|NCT00576472|141755018|SUPERIORITY_OR_OTHER|||||||0.4456||95.0|||||t-test, 2 sided|||||||0.4456
71086860|NCT03205150|141679521|SUPERIORITY||Mean Difference (Net)|3.56|STANDARD_ERROR_OF_MEAN|3.65||0.332|TWO_SIDED|80.0|-1.15|8.28|||ANCOVA|||||8.28|-1.15|0.332
71086861|NCT00871624|141679524|NON_INFERIORITY_OR_EQUIVALENCE|A difference in the mean four-point NIV intolerance score of 1 over the course of the study or between groups was considered through investigator consensus to be clinically meaningful. Assuming that the SD of NIV intolerance scores was 1 and that an alpha of 0.05 would be used for testing, it was determined that 18 subjects were needed in each group to achieve an 80% power.|Odds Ratio (OR)|1.44||||0.54|TWO_SIDED|95.0|0.44|4.7|||Chi-squared|||||4.7|0.44|0.54
71086862|NCT00871624|141679525|OTHER|||||||0.3|||||||Chi-squared|||||||0.3
71086863|NCT00729521|141679526|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.92|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED|95.0|0.88|0.95|||Mixed Models Analysis|Mixed Effects Poisson Regression|Comparison group is the control arm.|||0.95|0.88|<0.05
71086864|NCT00729521|141679526|SUPERIORITY_OR_OTHER||Incident Rate Ratio|0.91|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED|95.0|0.88|0.94|||Mixed Models Analysis|Mixed Effected Poisson Model Regression|Comparison group is the control arm.|||0.94|0.88|<.05
71124529|NCT00576472|141755019|SUPERIORITY_OR_OTHER|||||||0.5866||95.0|||||t-test, 2 sided|||||||0.5866
71124530|NCT00576472|141755020|SUPERIORITY_OR_OTHER|||||||0.8918||95.0|||||t-test, 2 sided|||||||0.8918
71124531|NCT00576472|141755021|SUPERIORITY_OR_OTHER|||||||0.4427||95.0|||||t-test, 2 sided|||||||0.4427
71124532|NCT00576472|141755022|SUPERIORITY_OR_OTHER|||||||0.4203||95.0|||||t-test, 2 sided|||||||0.4203
71124533|NCT00576472|141755023|SUPERIORITY_OR_OTHER|||||||0.5754||95.0|||||t-test, 2 sided|||||||0.5754
70945324|NCT01475461|141391152|SUPERIORITY_OR_OTHER||LS Mean Difference|1.17|STANDARD_ERROR_OF_MEAN|6.387||0.5727|TWO_SIDED|80.0|-7.03|9.37||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||9.37|-7.03|0.5727
71086865|NCT03652818|141679535|SUPERIORITY||Least Square (LS) Mean Difference|-25.2868|STANDARD_ERROR_OF_MEAN|16.1594|||ONE_SIDED|90.0||-4.421|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group D vs. Group B||-4.4210||
71124534|NCT00576472|141755024|SUPERIORITY_OR_OTHER|||||||0.0251||95.0|||||t-test, 2 sided|||||||0.0251
71124535|NCT00576472|141755025|SUPERIORITY_OR_OTHER|||||||0.1049||95.0|||||t-test, 2 sided|||||||0.1049
71124536|NCT00574548|141755028|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.0|||||TWO_SIDED|95.0|0.75|1.33|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 1: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.33|0.75|
71124537|NCT00574548|141755028|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.6|||||TWO_SIDED|95.0|1.24|1.94|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 3: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.94|1.24|
71124538|NCT00574548|141755028|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.0|||||TWO_SIDED|95.0|0.74|1.41|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 4: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.41|0.74|
71124539|NCT00574548|141755028|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.4|||||TWO_SIDED|95.0|1.01|2.0|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 5: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.00|1.01|
71124540|NCT00574548|141755028|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.7|||||TWO_SIDED|95.0|1.18|2.51|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 6B: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.51|1.18|
71124541|NCT00574548|141755028|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.6|||||TWO_SIDED|95.0|1.07|2.47|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 7F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.47|1.07|
71086866|NCT03652818|141679535|SUPERIORITY||LS Mean Difference|-0.2756|STANDARD_ERROR_OF_MEAN|16.3283|||ONE_SIDED|90.0||20.8083|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group C vs. Group B||20.8083||
71086867|NCT03652818|141679535|SUPERIORITY||LS Mean Difference|-65.9241|STANDARD_ERROR_OF_MEAN|17.2146|||ONE_SIDED|90.0||-43.6959|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group C vs. Group A||-43.6959||
71086868|NCT03652818|141679535|SUPERIORITY||LS Mean Difference|-65.6486|STANDARD_ERROR_OF_MEAN|16.8753|||ONE_SIDED|90.0||-43.8584|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group B vs. Group A||-43.8584||
71086869|NCT03652818|141679535|SUPERIORITY||LS Mean Difference|-90.9353|STANDARD_ERROR_OF_MEAN|17.1044|||ONE_SIDED|90.0||-68.8494|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group D vs. Group A||-68.8494||
71086870|NCT03652818|141679535|SUPERIORITY||LS Mean Difference|-25.0112|STANDARD_ERROR_OF_MEAN|16.5376|||ONE_SIDED|90.0||-3.6571|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group D vs. Group C||-3.6571||
71086871|NCT03652818|141679535|SUPERIORITY||LS Mean Difference|10.9546|STANDARD_ERROR_OF_MEAN|21.0237|||ONE_SIDED|90.0||38.1014|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group E vs. Group D||38.1014||
71086872|NCT03652818|141679536|SUPERIORITY||LS Mean Difference|33.6821|STANDARD_ERROR_OF_MEAN|20.1209|||ONE_SIDED|90.0|7.7011||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group D vs. Group B|||7.7011|
71086873|NCT03652818|141679536|SUPERIORITY||LS Mean Difference|6.1658|STANDARD_ERROR_OF_MEAN|20.3312|||ONE_SIDED|90.0|-20.0868||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group C vs. Group B|||-20.0868|
70945325|NCT01475461|141391152|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|6.578||0.4961|TWO_SIDED|80.0|-8.51|8.38||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||8.38|-8.51|0.4961
71086874|NCT03652818|141679536|SUPERIORITY||LS Mean Difference|77.3395|STANDARD_ERROR_OF_MEAN|21.4347|||ONE_SIDED|90.0|49.662||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group C vs. Group A|||49.6620|
71086875|NCT03652818|141679536|SUPERIORITY||LS Mean Difference|71.1737|STANDARD_ERROR_OF_MEAN|21.0123|||ONE_SIDED|90.0|44.0417||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group B vs. Group A|||44.0417|
71086876|NCT03652818|141679536|SUPERIORITY||LS Mean Difference|104.8558|STANDARD_ERROR_OF_MEAN|21.2975|||ONE_SIDED|90.0|77.3555||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group D vs. Group A|||77.3555|
71086877|NCT03652818|141679536|SUPERIORITY||LS Mean Difference|27.5163|STANDARD_ERROR_OF_MEAN|20.5918|||ONE_SIDED|90.0|0.9272||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group D vs. Group C|||0.9272|
71086878|NCT03652818|141679536|SUPERIORITY||LS Mean Difference|-30.1223|STANDARD_ERROR_OF_MEAN|26.1776|||ONE_SIDED|90.0|-63.924||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group E vs. Group D|||-63.9240|
71086879|NCT01811732|141679564|NON_INFERIORITY|A 2-sided 95% confidence interval (CI) for noninferiority testing was computed based on the difference in sample rates for vancomycin + aztreonam and delafloxacin at the primary endpoint. If the upper limit (UL) of the CI was less than 0.10, delafloxacin would be considered noninferior to vancomycin + aztreonam.|Difference in Responder Rates|-2.6|||||TWO_SIDED|95.0|-8.8|3.6||||||||3.6|-8.8|
71086880|NCT02974868|141679572|SUPERIORITY||Mean of Difference from Placebo|31.14|STANDARD_ERROR_OF_MEAN|6.25|<|0.0001|TWO_SIDED|95.0|18.78|43.5||Hochberg P-value (one-sided)|Mixed Model Repeated Measure (MMRM)|MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.||||43.50|18.78|<.0001
71124542|NCT00574548|141755028|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.3|||||TWO_SIDED|95.0|0.79|2.12|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 9V: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.12|0.79|
71124543|NCT00574548|141755028|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|0.8|||||TWO_SIDED|95.0|0.58|1.25|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 14: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.25|0.58|
71124544|NCT00574548|141755028|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.3|||||TWO_SIDED|95.0|0.94|1.93|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 18C: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.93|0.94|
71124545|NCT00574548|141755028|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.2|||||TWO_SIDED|95.0|0.96|1.61|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 19A: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.61|0.96|
71086881|NCT02974868|141679572|SUPERIORITY||Mean of Difference from Placebo|49.18|STANDARD_ERROR_OF_MEAN|6.35|<|0.0001|TWO_SIDED|95.0|36.62|61.74||Hochberg P-value (one-sided)|Mixed Model Repeated Measure (MMRM)|MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.||||61.74|36.62|<.0001
71086882|NCT02974868|141679573|OTHER||Mean of Difference from Placebo|25.78|STANDARD_ERROR_OF_MEAN|10.64||0.0094|TWO_SIDED|90.0|7.98|43.58|||Mixed Model Repeated Measure (MMRM)|MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.||||43.58|7.98|0.0094
71086883|NCT02974868|141679573|OTHER||Mean of Difference from Placebo|46.61|STANDARD_ERROR_OF_MEAN|10.51|<|0.0001|TWO_SIDED|90.0|29.02|64.2|||Mixed Model Repeated Measure|MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.||||64.20|29.02|<.0001
71086884|NCT02974868|141679578|OTHER||Difference in Percentage from Placebo|47.9|||<|0.0001|TWO_SIDED|90.0|34.2|60.7|||Chan and Zhang method|||||60.7|34.2|<.0001
71086885|NCT02974868|141679578|OTHER||Difference in Percentage from Placebo|61.7|||<|0.0001|TWO_SIDED|90.0|48.2|73.6|||Chan and Zhang method|||||73.6|48.2|<.0001
71086886|NCT03903172|141679640|SUPERIORITY||||||=|0.25|||||||t-test, 2 sided|||Day 0||||=0.25
71086887|NCT03903172|141679640|SUPERIORITY||||||=|0.93|||||||t-test, 2 sided|||Day 1||||=.93
71086888|NCT03903172|141679641|SUPERIORITY||||||=|1|||||||Fisher Exact|||Used acetominophen||||=1.0
71086889|NCT03903172|141679641|SUPERIORITY||||||=|1|||||||Fisher Exact|||Used ibuprofen||||=1.0
71086890|NCT03903172|141679641|SUPERIORITY||||||=|1|||||||Fisher Exact|||Used Cyclobenzaprine||||=1.0
71086891|NCT03903172|141679641|SUPERIORITY||||||=|0.11|||||||Fisher Exact|||Used Methocarbamol||||=.11
71086892|NCT03903172|141679641|SUPERIORITY||||||=|0.49|||||||Fisher Exact|||Used Hydroxyzine||||=.49
71086893|NCT03903172|141679641|SUPERIORITY||||||=|1|||||||Fisher Exact|||Used an 'Other' non-pharmacologic medication||||=1.0
71086894|NCT03903172|141679642|SUPERIORITY||||||=|1|||||||Fisher Exact|||Any narcotic medication used||||=1.0
71086895|NCT01545388|141679643|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.678|||<|0.001|TWO_SIDED|95.0|-0.868|-0.489|||cLDA|Based on a cLDA model with the terms listed above and a constraint that the mean baseline is the same for all treatment groups.||||-0.489|-0.868|<0.001
71086896|NCT01545388|141679643|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.525|||<|0.001|TWO_SIDED|95.0|-0.713|-0.337|||cLDA|Based on a cLDA model with the terms listed above and a constraint that the mean baseline is the same for all treatment groups.||||-0.337|-0.713|<0.001
71086897|NCT01545388|141679643|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin (Δ) is set as 0.3% to show the non-inferiority of metformin 500 mg q.d. to metformin 250 mg b.i.d.|Difference in least squares means|0.153|||||TWO_SIDED|95.0|0.0|0.306||||||||0.306|0.000|
71086898|NCT01545388|141679644|SUPERIORITY_OR_OTHER||Difference in least squares means|-18.59|||<|0.001|TWO_SIDED|95.0|-25.94|-11.24|||cLDA|Based on a cLDA model with the terms listed above and a constraint that the mean baseline is the same for all treatment groups.||||-11.24|-25.94|<0.001
71086899|NCT01545388|141679644|SUPERIORITY_OR_OTHER||Difference in least squares means|-16.34|||<|0.001|TWO_SIDED|95.0|-23.62|-9.06|||cLDA|Based on a cLDA model with the terms listed above and a constraint that the mean baseline is the same for all treatment groups.||||-9.06|-23.62|<0.001
71086900|NCT01545388|141679644|SUPERIORITY_OR_OTHER||Difference in least squares mean|2.25|||||TWO_SIDED|95.0|-3.63|8.14||||||||8.14|-3.63|
71086901|NCT04613518|141679674|SUPERIORITY||Mean Difference (Final Values)|3.8|||||TWO_SIDED|95.0|-35.7|43.4||||||||43.4|-35.7|
71086902|NCT05616013|141679679|SUPERIORITY||LS Mean Change difference|-14.5|||<|0.001|TWO_SIDED|95.0|-18.0|-11.0|||ANCOVA|||Bima 30mg/kg + Sema 2.4mg vs Placebo||-11.0|-18.0|<0.001
71086903|NCT05616013|141679679|SUPERIORITY||LS Mean Change difference|-10.5|||<|0.001|TWO_SIDED|95.0|-14.0|-7.09|||ANCOVA|||Bima 30mg/kg + Sema 1.0mg vs Placebo||-7.09|-14.0|<0.001
71086904|NCT05616013|141679679|SUPERIORITY||LS Mean Change difference|-11.0|||<|0.001|TWO_SIDED|95.0|-14.4|-7.55|||ANCOVA|||Bima 10mg/kg + Sema 2.4mg vs Placebo||-7.55|-14.4|<0.001
71124546|NCT00574548|141755028|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.09|2.12|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 19F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.12|1.09|
71086905|NCT05616013|141679679|SUPERIORITY||LS Mean Change difference|-9.41|||<|0.001|TWO_SIDED|95.0|-12.9|-5.93|||ANCOVA|||Bima 10mg/kg + Sema 1.0mg vs Placebo||-5.93|-12.9|<.001
71086906|NCT05616013|141679679|SUPERIORITY||LS Mean Change difference|-10.9|||<|0.001|TWO_SIDED|95.0|-14.4|-7.46|||ANCOVA|||Sema 2.4mg vs Placebo||-7.46|-14.4|<0.001
71086907|NCT05616013|141679679|SUPERIORITY||LS Mean Change difference|-6.45|||<|0.001|TWO_SIDED|95.0|-9.96|-2.94|||ANCOVA|||Sema 1.0mg vs Placebo||-2.94|-9.96|<0.001
71086908|NCT05616013|141679679|SUPERIORITY||LS Mean Change difference|-5.94|||<|0.001|TWO_SIDED|95.0|-9.47|-2.41|||ANCOVA|||Bima 30mg/kg vs Placebo||-2.41|-9.47|<0.001
71086909|NCT05616013|141679679|SUPERIORITY||LS Mean Change difference|-2.68||||0.133|TWO_SIDED|95.0|-6.18|0.82|||ANCOVA|||Bima 10mg/kg vs Placebo||0.82|-6.18|0.133
71086910|NCT05116202|141679720|SUPERIORITY||Difference in pRR|2.73|||||TWO_SIDED|95.0|-22.25|27.7||||||||27.70|-22.25|
71086911|NCT05116202|141679720|SUPERIORITY||Difference in pRR|-32.27|||||TWO_SIDED|95.0|-65.01|0.46||||||||0.46|-65.01|
71086912|NCT05116202|141679720|SUPERIORITY||Difference in pRR|-17.27|||||TWO_SIDED|95.0|-49.75|15.21||||||||15.21|-49.75|
71086913|NCT05116202|141679722|SUPERIORITY||Difference in pRR|-6.82|||||TWO_SIDED|95.0|-31.31|17.68||||||||17.68|-31.31|
71086914|NCT05116202|141679722|SUPERIORITY||Difference in pRR|-31.82|||||TWO_SIDED|95.0|-63.79|0.16||||||||0.16|-63.79|
71086915|NCT05116202|141679722|SUPERIORITY||Difference in pRR|-21.82|||||TWO_SIDED|95.0|-53.44|9.8||||||||9.80|-53.44|
71086916|NCT05116202|141679723|SUPERIORITY||Hazard Ratio (HR)|2.09|||||TWO_SIDED|95.0|0.42|10.42||||||||10.42|0.42|
71086917|NCT05116202|141679723|SUPERIORITY||Hazard Ratio (HR)|3.95|||||TWO_SIDED|95.0|0.79|19.7||||||||19.70|0.79|
71086918|NCT05116202|141679723|SUPERIORITY||Hazard Ratio (HR)|6.27|||||TWO_SIDED|95.0|0.73|53.7||||||||53.70|0.73|
71086919|NCT05116202|141679724|SUPERIORITY||Hazard Ratio (HR)|1.41|||||TWO_SIDED|95.0|0.25|7.75||||||||7.75|0.25|
71086920|NCT05116202|141679724|SUPERIORITY||Hazard Ratio (HR)|2.09|||||TWO_SIDED|95.0|0.35|12.62||||||||12.62|0.35|
71086921|NCT05116202|141679724|SUPERIORITY||Hazard Ratio (HR)|2.39|||||TWO_SIDED|95.0|0.22|26.32||||||||26.32|0.22|
71086922|NCT05116202|141679725|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.05|12.39||||||||12.39|0.05|
71086923|NCT05116202|141679725|SUPERIORITY||Hazard Ratio (HR)|2.59|||||TWO_SIDED|95.0|0.23|28.65||||||||28.65|0.23|
71086924|NCT05116202|141679725|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.07|18.58||||||||18.58|0.07|
71086925|NCT05116202|141679726|SUPERIORITY||Difference in ORR|-21.59|||||TWO_SIDED|95.0|-50.55|7.37||||||||7.37|-50.55|
71086926|NCT05116202|141679726|SUPERIORITY||Difference in ORR|-24.09|||||TWO_SIDED|95.0|-58.17|9.99||||||||9.99|-58.17|
71086927|NCT05116202|141679726|SUPERIORITY||Difference in ORR|0.91|||||TWO_SIDED|95.0|-33.58|35.4||||||||35.40|-33.58|
71086928|NCT01721447|141679770|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||< 0.001
71086929|NCT01721447|141679771|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||< 0.001
71086930|NCT02322749|141679772|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% confidence intervals for both AUC and Cmax were entirely contained within the limits 80.00% to 125.00% then bioequivalence was concluded.|Geometric Least Squares (LS) Mean Ratio|9.32|||||TWO_SIDED|90.0|8.25|10.53|||||Selumetinib: Ratio of Treatment B to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||10.53|8.25|
71086931|NCT02322749|141679773|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% confidence intervals for both AUC and Cmax were entirely contained within the limits 80.00% to 125.00% then bioequivalence was concluded.|Geometric LS Mean Ratio|24.26|||||TWO_SIDED|90.0|22.62|26.03|||||Selumetinib: Ratio of Treatment B to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||26.03|22.62|
70945326|NCT01475461|141391152|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|6.411||0.2616|TWO_SIDED|80.0|-12.33|4.14||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||4.14|-12.33|0.2616
71086932|NCT02322749|141679774|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% confidence intervals for both AUC and Cmax were entirely contained within the limits 80.00% to 125.00% then bioequivalence was concluded.|Geometric LS mean ratio|22.12|||||TWO_SIDED|90.0|20.65|23.69|||||Selumetinib: Ratio of Treatment B to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||23.69|20.65|
71086933|NCT02322749|141679775|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|12.93|||||TWO_SIDED|90.0|11.42|14.65|||||Selumetinib: Ratio of Treatment C to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||14.65|11.42|
71086934|NCT02322749|141679776|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|26.2|||||TWO_SIDED|90.0|24.44|28.09|||||Selumetinib: Ratio of Treatment C to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||28.09|24.44|
71086935|NCT02322749|141679777|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|23.6|||||TWO_SIDED|90.0|22.02|25.3|||||Selumetinib: Ratio of Treatment C to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||25.30|22.02|
71086936|NCT02322749|141679778|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|9.66|||||TWO_SIDED|90.0|8.5|10.97|||||N-desmethyl selumetinib: Ratio of Treatment B to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect|||10.97|8.5|
71086937|NCT02322749|141679778|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|13.04|||||TWO_SIDED|90.0|11.45|14.86|||||N-desmethyl selumetinib: Ratio of Treatment C to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||14.86|11.45|
71086938|NCT02322749|141679779|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|11.31|||||TWO_SIDED|90.0|9.8|13.05|||||N-desmethyl selumetinib: Ratio of Treatment B to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||13.05|9.80|
71086939|NCT02322749|141679779|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|12.8|||||TWO_SIDED|90.0|11.07|14.8|||||N-desmethyl selumetinib: Ratio of Treatment C to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||14.80|11.07|
71086940|NCT04414787|141679815|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-6.21|6.21|||Mixed Models Analysis|||Difference between Time 1 (baseline) and Time 3 (\~1 week post-randomization)||6.21|-6.21|1.00
71086941|NCT04414787|141679816|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.95|TWO_SIDED|95.0|-1.83|1.72|||Mixed Models Analysis|||Difference between Time 1 (baseline) and Time 4 (3 months post-randomization)||1.72|-1.83|0.95
71086942|NCT04414787|141679817|SUPERIORITY||Mean Difference (Final Values)|0.29||||0.72|TWO_SIDED|95.0|-1.28|1.86|||Mixed Models Analysis|||Difference between Time 1 (baseline) and Time 4 (3 months post-randomization)||1.86|-1.28|0.72
71086943|NCT04414787|141679818|SUPERIORITY||Mean Difference (Final Values)|1.35||||0.48|TWO_SIDED|95.0|-2.44|5.14|||Mixed Models Analysis|||Difference between Time 1 (baseline) and Time 4 (3 months post-randomization)||5.14|-2.44|0.48
71086944|NCT04414787|141679819|SUPERIORITY||Odds Ratio (OR)|0.49||||0.12|TWO_SIDED|95.0|0.2|1.2|||Mixed Models Analysis|||Difference between Time 1 (baseline) and Time 3 (target \~1 week post-randomization)||1.2|0.20|0.12
71086945|NCT04414787|141679820|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||||||0.58
71086946|NCT04414787|141679821|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
71086947|NCT04414787|141679822|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
71086948|NCT01121263|141679833|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.063||||0.8||95.0|0.666|1.697|||Regression, Cox|The Cox proportional hazards regression model was weighted by propensity score to adjust for differences in baseline risk between the two groups.|The Cox model was weighted by propensity score to adjust for differences in baseline risk between the two groups.|This applies to any MACCE||1.697|0.666|0.80
71086949|NCT01121263|141679834|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.868||||0.53||95.0|0.556|1.355|||Regression, Cox||The Cox proportional hazards regression model was weighted by the propensity score to account for the difference in baseline risk between groups.|This applies to any MACCE||1.355|0.556|0.53
71086950|NCT00789321|141679890|SUPERIORITY_OR_OTHER||Least Squares Mean|-11.7||||0.001||90.0|-18.1|-5.4|||ANCOVA|Change from baseline in systolic blood pressure included as covariate||||-5.4|-18.1|0.001
71086951|NCT00789321|141679891|SUPERIORITY_OR_OTHER||Least Squares Mean|39.0||||0.001||95.0|17.9|60.1|||ANCOVA|Change from baseline in systolic blood pressure included as covariate||||60.1|17.9|0.001
71086952|NCT03964207|141679893|SUPERIORITY||Difference of LSmeans|-5.28||||0.007|TWO_SIDED|95.0|-9.07|-1.48|||Mixed-effects Model||The Least squares means (LSmeans) were adjusted with treatment and visit. And the Difference of LSmeans was calculated as: value from the test treatment group - value from the comparator treatment group.|The hypothesis test was held to investigate the superiority of the test treatment. Mixed-effects Model for Repeated Measures (MMRM) was used to analyze the performance domain of PASAPQ score, with treatment and period as fixed effects, and patient as a random effect.||-1.48|-9.07|0.007
71086953|NCT03964207|141679894|SUPERIORITY||Difference of LSmeans|-4.14||||0.024|TWO_SIDED|95.0|-7.72|-0.56|||Mixed Models Analysis||The Least squares means (LSmeans) were adjusted with treatment and visit. And the Difference of LSmeans was calculated as: value from the test treatment group - value from the comparator treatment group.|The hypothesis test was held to investigate the superiority of the test treatment. Mixed-effects Model for Repeated Measures (MMRM) was used to analyze the performance domain of PASAPQ score, with treatment and period as fixed effects, and patient as a random effect||-0.56|-7.72|0.024
71124547|NCT00574548|141755028|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|2.8|||||TWO_SIDED|95.0|1.86|4.35|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 23F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||4.35|1.86|
71124548|NCT00574548|141755029|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.9|||||TWO_SIDED|95.0|1.43|2.57|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 1: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.57|1.43|
71124549|NCT00574548|141755029|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|2.5|||||TWO_SIDED|95.0|1.95|3.16|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 3: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.16|1.95|
71124550|NCT00574548|141755029|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.12|1.96|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 4: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.96|1.12|
71124551|NCT00574548|141755029|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|2.4|||||TWO_SIDED|95.0|1.67|3.31|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 5: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.31|1.67|
71124552|NCT00574548|141755029|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.7|||||TWO_SIDED|95.0|1.19|2.47|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 6B: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.47|1.19|
71124553|NCT00574548|141755029|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|4.3|||||TWO_SIDED|95.0|2.76|6.61|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 7F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||6.61|2.76|
71124554|NCT00574548|141755029|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|3.3|||||TWO_SIDED|95.0|1.97|5.45|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 9V: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||5.45|1.97|
71124555|NCT00574548|141755029|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.4|||||TWO_SIDED|95.0|0.98|2.1|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 14: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.10|0.98|
71124556|NCT00574548|141755029|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.9|||||TWO_SIDED|95.0|1.32|2.69|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 18C: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.69|1.32|
71124557|NCT00574548|141755029|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.6|||||TWO_SIDED|95.0|1.27|2.07|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 19A: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.07|1.27|
71124558|NCT00574548|141755029|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|2.7|||||TWO_SIDED|95.0|1.96|3.74|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 19F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.74|1.96|
70945327|NCT01475461|141391152|SUPERIORITY_OR_OTHER||LS Mean Difference|9.06|STANDARD_ERROR_OF_MEAN|6.441||0.9197|TWO_SIDED|80.0|0.79|17.34||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||17.34|0.79|0.9197
70945328|NCT01475461|141391152|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.76|STANDARD_ERROR_OF_MEAN|6.398||0.086|TWO_SIDED|80.0|-16.98|-0.54||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.54|-16.98|0.0860
70945329|NCT01475461|141391152|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|6.476||0.5132|TWO_SIDED|80.0|-8.1|8.53||p-value was 1-sided.|t-test, 1 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||8.53|-8.10|0.5132
71086954|NCT03964207|141679895|SUPERIORITY||Difference rate (%)|13.0||||0.249|||||||Chi-square test||The Difference rate was calculated as: value from the test treatment group - value from the comparator treatment group.|Chi-squared test was used to analyze proportion of patients indicating preference in the Patient satisfaction and preference questionnaire (PASAPQ) at week 8. All participants have used both treatments at this point: Handihaler (4 weeks) and Respimat (4 weeks).||||0.249
71086955|NCT03964207|141679896|SUPERIORITY||Difference of LSmeans|-4.72||||0.057|TWO_SIDED|95.0|-9.59|0.15|||The mixed model for repeated measures||The Least squares means (LSmeans) were adjusted with treatment and visit. And the Difference of LSmeans was calculated as: value from the test treatment group - value from the comparator treatment group.|The hypothesis test was held to investigate the superiority of the test treatment. Mixed-effects Model for Repeated Measures (MMRM) was used to analyze the performance domain of PASAPQ score, with treatment and period as fixed effects, and patient as a random effect.||0.15|-9.59|0.057
71086956|NCT03964207|141679897|SUPERIORITY||Difference of LSmeans|-4.38||||0.347|TWO_SIDED|95.0|-13.63|4.86|||Mixed Models Analysis||The Least squares means (LSmeans) were adjusted with treatment and visit. And the Difference of LSmeans was calculated as: value from the test treatment group - value from the comparator treatment group.|The hypothesis test was held to investigate the superiority of the test treatment. Mixed-effects Model for Repeated Measures (MMRM) was used to analyze the performance domain of PASAPQ score, with treatment and period as fixed effects, and patient as a random effect.||4.86|-13.63|0.347
71086957|NCT02452047|141679946|OTHER|Difference in percentages|Difference in FOR %|-7.3|||||TWO_SIDED|90.0|-27.5|21.4|||||Stratified Miettinen \& Nurminen method by infection type|||21.4|-27.5|
71086958|NCT02452047|141679947|OTHER|Difference in percentages|Difference in AE %|-10.3|||||TWO_SIDED|95.0|-33.1|18.0|||||Miettinen \& Nurminen method|||18.0|-33.1|
71086959|NCT02452047|141679948|OTHER|Difference in percentages|Difference in SAE %|-21.6|||||TWO_SIDED|95.0|-47.8|1.3|||||Miettinen \& Nurminen method|||1.3|-47.8|
71086960|NCT02452047|141679949|OTHER|Difference in percentages|Difference in drug-related AE %|-15.1|||||TWO_SIDED|95.0|-42.3|9.2|||||Miettinen \& Nurminen method|||9.2|-42.3|
71086961|NCT02452047|141679950|OTHER|Difference in percentages|Difference in drug-related SAE %|0.0|||||TWO_SIDED|95.0|-19.7|11.2|||||Miettinen \& Nurminen method|||11.2|-19.7|
71086962|NCT02452047|141679951|OTHER|Difference in percentages|Difference in discontinuation %|-18.8|||||TWO_SIDED|95.0|-43.3|-6.2|||||Miettinen \& Nurminen method|||-6.2|-43.3|
71086963|NCT02452047|141679952|OTHER|Difference in percentages|Difference in drug-related discon %|-12.5|||||TWO_SIDED|95.0|-36.3|-0.3|||||Miettinen \& Nurminen method|||-0.3|-36.3|
71086964|NCT02452047|141679953|OTHER|Difference in percentages|Difference in pyrexia %|0.4|||||TWO_SIDED|95.0|-25.2|19.7|||||Miettinen \& Nurminen method|||19.7|-25.2|
71086965|NCT02452047|141679953|OTHER|Difference in percentages|Difference blood creatinine inc %|-25.0|||||TWO_SIDED|95.0|-49.8|-10.1|||||Miettinen \& Nurminen method|||-10.1|-49.8|
71086966|NCT02452047|141679954|OTHER|Difference in Category 1 ECI %|Difference in Category 1 ECI %|-12.5||||0.047|TWO_SIDED|95.0|-36.3|-0.3|||Miettinen and Nurminen method|||||-0.3|-36.3|0.047
71086967|NCT02452047|141679954|OTHER|Difference in Category 2 ECI %|Difference in Category 2 ECI %|-12.5||||0.047||95.0|-36.3|-0.3|||Miettinen and Nurminen method|||||-0.3|-36.3|0.047
71086968|NCT02452047|141679955|OTHER|Difference in percentages|Difference in nephrotoxicity %|-45.9||||0.002||95.0|-69.1|-18.4|||Fisher Exact||Miettinen \& Nurminen method|||-18.4|-69.1|0.002
70945330|NCT01475461|141391152|SUPERIORITY_OR_OTHER||LS Mean Difference|2.68|STANDARD_ERROR_OF_MEAN|6.676||0.656|TWO_SIDED|80.0|-5.89|11.26||p-value was 1-sided.|t-test, 1 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||11.26|-5.89|0.6560
71086969|NCT02452047|141679956|OTHER|Difference in Day 28 FCR %|Difference in Day 28 FCR %|26.3|||||TWO_SIDED|90.0|1.3|51.5|||||Miettinen and Nurminen method stratified by infection-site stratum|||51.5|1.3|
71086970|NCT02452047|141679957|OTHER|Difference in mortality %|Difference in mortality %|-17.3|||||TWO_SIDED|90.0|-46.4|6.7|||||Miettinen and Nurminen method stratified by infection-site stratum|||6.7|-46.4|
71086971|NCT02452047|141679958|OTHER|Adjusted difference in OTX FCR %|Adjusted difference in OTX FCR %|33.9|||||TWO_SIDED|90.0|7.4|61.1|||||Miettinen and Nurminen method stratified by infection-site stratum|||61.1|7.4|
71086972|NCT02452047|141679959|OTHER|Adjusted difference in EOT FCR %|Adjusted difference in EOT FCR %|25.4|||||TWO_SIDED|90.0|3.1|53.6|||||Miettinen and Nurminen method stratified by infection-site stratum|||53.6|3.1|
71086973|NCT02452047|141679960|OTHER|Adjusted difference in EFU FCR %|Difference in EFU FCR %|24.7|||||TWO_SIDED|90.0|3.8|51.4|||||Miettinen and Nurminen method stratified by infection-site stratum|||51.4|3.8|
71086974|NCT02452047|141679961|OTHER|Difference in percentages|Difference in FMR %|0.0|||||TWO_SIDED|90.0|-20.8|36.6|||||Miettinen \& Nurminen method|||36.6|-20.8|
71086975|NCT02452047|141679962|OTHER|Difference in percentages|Difference in FMR %|0.0|||||TWO_SIDED|90.0|-20.8|36.6|||||Miettinen \& Nurminen method|||36.6|-20.8|
71086976|NCT02452047|141679963|OTHER|Difference in percentages|Difference in FMR %|-27.3|||||TWO_SIDED|90.0|-52.8|12.8|||||Miettinen \& Nurminen method|||12.8|-52.8|
71086977|NCT00288912|141679964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.007|TWO_SIDED|95.0|-1.0|0.2|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Primary hypothesis: OA self-management intervention results in greater improvement in AIMS2 pain score than usual care or health education control. Sample size estimate based on detecting 0.57 point (14%) difference between groups. Analyses were linear mixed models, intent-to-treat basis.||0.2|-1.0|0.007
71086978|NCT00288912|141679964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.105|TWO_SIDED|95.0|-0.8|0.1|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Primary hypothesis: OA self-management intervention results in greater improvement in AIMS2 pain score than usual care or health education control. Sample size estimate based on detecting 0.57 point (14%) difference between groups. Analyses were linear mixed models, intent-to-treat basis.||0.1|-0.8|0.105
71086979|NCT00288912|141679965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.093|TWO_SIDED|95.0|-0.5|0.0|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in AIMS2 function score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.||0.0|-0.5|0.093
71086980|NCT00288912|141679965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.43|TWO_SIDED|95.0|-0.2|0.2|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in AIMS2 function score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.||0.2|-0.2|0.43
71086981|NCT00288912|141679966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.78|TWO_SIDED|95.0|-0.3|0.4|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in AIMS2 affect score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.||0.4|-0.3|0.78
71086982|NCT00288912|141679966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.79|TWO_SIDED|95.0|-0.3|0.4|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in AIMS2 affect score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.||0.4|-0.3|0.79
71086983|NCT00288912|141679967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.043|TWO_SIDED|95.0|0.0|0.8|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in arthritis self-efficacy score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.||0.8|0.0|0.043
71086984|NCT00288912|141679967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.066|TWO_SIDED|95.0|0.0|0.7|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in arthritis self-efficacy score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.||0.7|0.0|0.066
71086985|NCT02026141|141679975|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|||||||<0.05
71086986|NCT03191799|141680017|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 3 vs. Baseline||||<0.0001
71086987|NCT03191799|141680017|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 6 vs. Baseline||||<0.0001
71086988|NCT03191799|141680017|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 12 vs. Baseline||||<0.0001
71086989|NCT03191799|141680017|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 18 vs. Baseline||||<0.0001
71086990|NCT03191799|141680017|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Early Terminatinon/Study Completion vs. Baseline||||<0.0001
71086991|NCT03191799|141680019|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 3 vs. Baseline||||<0.0001
71086992|NCT03191799|141680019|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 6 vs. Baseline||||<0.0001
71086993|NCT03191799|141680019|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 12 vs. Baseline||||<0.0001
71086994|NCT03191799|141680019|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 18 vs. Baseline||||<0.0001
71086995|NCT03191799|141680019|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Early Terminatinon/Study Completion vs. Baseline||||<0.0001
71086996|NCT03191799|141680030|SUPERIORITY|||||||0.0001|||||||Paired t-test|||Month 3 vs. Baseline||||0.0001
71086997|NCT03191799|141680030|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 6 vs. Baseline||||<0.0001
71086998|NCT03191799|141680030|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 12 vs. Baseline||||<0.0001
71086999|NCT03191799|141680030|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 18 vs. Baseline||||<0.0001
71087000|NCT03191799|141680030|SUPERIORITY|||||||0.0004|||||||Paired t-test|||Early Terminatinon/Study Completion vs. Baseline||||0.0004
71087001|NCT03191799|141680032|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 3 vs. Baseline||||<0.0001
71087002|NCT03191799|141680032|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 6 vs. Baseline||||<0.0001
70856961|NCT02446743|141200497|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|vaccine group ratio of GMTs|14.0|||||TWO_SIDED|95.0|9.05|20.0|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||20|9.05|
71087003|NCT03191799|141680032|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 12 vs. Baseline||||<0.0001
71087004|NCT03191799|141680032|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 18 vs. Baseline||||<0.0001
71087005|NCT03191799|141680032|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Early Terminatinon/Study Completion vs. Baseline||||<0.0001
71087006|NCT03191799|141680042|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 3 vs. Baseline||||<0.0001
71087007|NCT03191799|141680042|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 6 vs. Baseline||||<0.0001
71087008|NCT03191799|141680042|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 12 vs. Baseline||||<0.0001
71087009|NCT03191799|141680042|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 18 vs. Baseline||||<0.0001
70856962|NCT02446743|141200497|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group ratio of GMTs|1.5|||||TWO_SIDED|95.0|1.26|1.78|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||1.78|1.26|
71087010|NCT03191799|141680042|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Early Terminatinon/Study Completion vs. Baseline||||<0.0001
71087011|NCT03191799|141680043|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 3 vs. Baseline||||<0.0001
71087012|NCT03191799|141680043|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 6 vs. Baseline||||<0.0001
71087013|NCT03191799|141680043|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 12 vs. Baseline||||<0.0001
71087014|NCT03191799|141680043|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 18 vs. Baseline||||<0.0001
71087015|NCT03191799|141680043|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Early Terminatinon/Study Completion vs. Baseline||||<0.0001
71087016|NCT01240382|141680102|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority in mean change in fluorescein staining score from baseline was assessed on the non-inferiority margin (0.34) with the upper limit of the confidence interval of the difference between the 2 treatment groups.|Median Difference (Final Values)|-0.03||||||95.0|-0.405|0.338|||l|||||0.338|-0.405|
71087017|NCT01240382|141680103|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.67||||0.01||95.0|-1.18|-0.67|||t-test, 2 sided|||||-0.67|-1.18|0.010
71087018|NCT02456727|141680107|SUPERIORITY||Mean Difference (Net)|-0.3714|STANDARD_ERROR_OF_MEAN|0.2039||0.0691|TWO_SIDED|95.0|-0.772|0.0291|||ANCOVA|The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).|||0.0291|-0.7720|0.0691
71087019|NCT02456727|141680108|SUPERIORITY||Mean Difference (Net)|-0.1631|STANDARD_ERROR_OF_MEAN|0.246||0.5077|TWO_SIDED|95.0|-0.6452|0.319|||ANCOVA|The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).|||0.319|-0.6452|0.5077
71087020|NCT02456727|141680109|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0724|STANDARD_ERROR_OF_MEAN|0.0399||0.24|TWO_SIDED|95.0|-0.0058|0.1506|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 12 weeks between two treatment arms (Individual-Group)|||0.1506|-0.0058|0.24
71087021|NCT02456727|141680110|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0531|STANDARD_ERROR_OF_MEAN|0.0487||0.17|TWO_SIDED|95.0|-0.0422|0.1485|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 12 weeks between two treatment arms (Individual-Group)|||0.1485|-0.0422|0.17
71087022|NCT02456727|141680111|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0625|STANDARD_ERROR_OF_MEAN|0.0396||0.17|TWO_SIDED|95.0|-0.0151|0.1401|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 24 weeks between two treatment arms (Individual-Group)|||0.1401|-0.0151|0.17
71087023|NCT02456727|141680112|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0882|STANDARD_ERROR_OF_MEAN|0.0488||0.4|TWO_SIDED|95.0|-0.0075|0.184|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 24 weeks between two treatment arms (Individual-Group)|||0.184|-0.0075|0.40
71087024|NCT02456727|141680113|SUPERIORITY||Mean Difference (Net)|-0.2643|STANDARD_ERROR_OF_MEAN|0.1782||0.1387|TWO_SIDED|95.0|-0.6136|0.0851|||ANCOVA|The outcome is the change in score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between the two treatment arms (Individual-Group).|||0.0851|-0.6136|0.1387
71087025|NCT02456727|141680114|SUPERIORITY||Mean Difference (Net)|-0.2334|STANDARD_ERROR_OF_MEAN|0.2124||0.2725|TWO_SIDED|95.0|-0.6497|0.1829|||ANCOVA|The outcome is the change in score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between the two treatment arms (Individual-Group).|||0.1829|-0.6497|0.2725
71087026|NCT02456727|141680115|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0426|STANDARD_ERROR_OF_MEAN|0.0388||0.07|TWO_SIDED|95.0|-0.0334|0.1185|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 12 weeks between two treatment arms (Individual-Group)|||0.1185|-0.0334|0.07
71087027|NCT02456727|141680116|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0283|STANDARD_ERROR_OF_MEAN|0.0477||0.07|TWO_SIDED|95.0|-0.0651|0.1218|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 12 weeks between two treatment arms (Individual-Group)|||0.1218|-0.0651|0.07
71087028|NCT02456727|141680117|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0262|STANDARD_ERROR_OF_MEAN|0.0356||0.02|TWO_SIDED|95.0|-0.0436|0.0961|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 24 weeks between two treatment arms (Individual-Group)|||0.0961|-0.0436|0.02
71087029|NCT02456727|141680118|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0323|STANDARD_ERROR_OF_MEAN|0.044||0.06|TWO_SIDED|95.0|-0.0539|0.1186|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 24 weeks between two treatment arms (Individual-Group)|||0.1186|-0.0539|0.06
71087030|NCT02456727|141680119|SUPERIORITY||Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.15||0.1475|TWO_SIDED|95.0|-0.5288|0.0795|||t-test, 2 sided|The outcome is the change of PGIC from baseline to 12 weeks.|The estimated value is the difference of PGIC change from baseline to 12 weeks between two treatment arms (Individual-Group).|||0.0795|-0.5288|0.1475
71087031|NCT02456727|141680120|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.18||0.3038|TWO_SIDED|95.0|-0.546|0.1706|||t-test, 2 sided|The outcome is the change of PGIC from baseline to 12 weeks.|The estimated value is the difference of PGIC change from baseline to 12 weeks between two treatment arms (Individual-Group).|||0.1706|-0.546|0.3038
71087032|NCT02456727|141680121|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0251|STANDARD_ERROR_OF_MEAN|0.0392||0.03|TWO_SIDED|95.0|-0.0517|0.1018|||Chi-squared||The estimated value is the difference of proportion of respondents (change post treatment\>=6) at 12 weeks between two treatment arms (Individual-Group)|||0.1018|-0.0517|0.03
71087033|NCT02456727|141680122|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0018|STANDARD_ERROR_OF_MEAN|0.0481||0.02|TWO_SIDED|95.0|-0.0925|0.096|||Chi-squared||The estimated value is the difference of proportion of respondents (change post treatment\>=6) at 12 weeks between two treatment arms (Individual-Group)|||0.096|-0.0925|0.02
71087034|NCT02456727|141680123|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|-0.0104|STANDARD_ERROR_OF_MEAN|0.036||0|TWO_SIDED|95.0|-0.081|0.0602|||Chi-squared||The estimated value is the difference of proportion of respondents (change post treatment\>=6) at 24 weeks between two treatment arms (Individual-Group)|||0.0602|-0.081|0.00
71087035|NCT02456727|141680124|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0154|STANDARD_ERROR_OF_MEAN|0.0464||0.03|TWO_SIDED|95.0|-0.0755|0.1063|||Chi-squared||The estimated value is the difference of proportion of respondents (change post treatment\>=6) at 24 weeks between two treatment arms (Individual-Group)|||0.1063|-0.0755|0.03
71124559|NCT00574548|141755029|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.6|||||TWO_SIDED|95.0|1.05|2.45|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 23F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.45|1.05|
71124560|NCT00574548|141755030|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.54|0.82|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 1: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.82|0.54|
71124561|NCT00574548|141755030|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|0.99|1.49|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 3: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.49|0.99|
71124562|NCT00574548|141755030|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.43|0.68|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 4: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.68|0.43|
71124563|NCT00574548|141755030|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.43|0.77|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 5: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.77|0.43|
71124564|NCT00574548|141755030|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.67|1.08|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 6A: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.08|0.67|
71124565|NCT00574548|141755030|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.71|1.12|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 6B: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.12|0.71|
71124566|NCT00574548|141755030|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.24|0.49|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 7F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.49|0.24|
70856963|NCT02446743|141200497|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|vaccine group ratio of GMTs|1.3|||||TWO_SIDED|95.0|1.11|1.51|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||1.51|1.11|
70945331|NCT01475461|141391152|SUPERIORITY_OR_OTHER||LS Mean Difference|6.17|STANDARD_ERROR_OF_MEAN|6.496||0.8285|TWO_SIDED|80.0|-2.17|14.52||p-value was 1-sided.|t-test, 1 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||14.52|-2.17|0.8285
71124567|NCT00574548|141755030|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.26|0.51|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 9V: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.51|0.26|
70945332|NCT01475461|141391152|SUPERIORITY_OR_OTHER||LS Mean Difference|15.98|STANDARD_ERROR_OF_MEAN|6.527||0.9925|TWO_SIDED|80.0|7.59|24.36||p-value was 1-sided.|t-test, 1 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||24.36|7.59|0.9925
71124568|NCT00574548|141755030|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.6|1.02|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 14: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.02|0.60|
71124569|NCT00574548|141755030|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.54|0.87|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 18C: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.87|0.54|
71124570|NCT00574548|141755030|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.53|0.82|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 19A: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.82|0.53|
71124571|NCT00574548|141755030|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.69|1.15|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 19F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.15|0.69|
71124572|NCT00574548|141755030|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|1.6|||||TWO_SIDED|95.0|1.15|2.13|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 23F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||2.13|1.15|
71124573|NCT00574548|141755031|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.55|0.75|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 1: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.75|0.55|
71124574|NCT00574548|141755031|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.52|2.01|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 3: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||2.01|1.52|
71124575|NCT00574548|141755031|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.49|0.66|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 4: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.66|0.49|
71124576|NCT00574548|141755031|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.67|1.03|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 5: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.03|0.67|
71124577|NCT00574548|141755031|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.57|0.79|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 6B: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.79|0.57|
71124578|NCT00574548|141755031|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.35|0.52|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 7F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.52|0.35|
70945333|NCT01475461|141391152|SUPERIORITY_OR_OTHER||LS Mean Difference|1.66|STANDARD_ERROR_OF_MEAN|6.487||0.601|TWO_SIDED|80.0|-6.67|10.0||p-value was 1-sided.|t-test, 1 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||10.00|-6.67|0.6010
71087036|NCT02456727|141680125|SUPERIORITY||Mean Difference (Net)|0.082|STANDARD_ERROR_OF_MEAN|0.5336||0.8778|TWO_SIDED|95.0|-0.9659|1.13|||ANCOVA|The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).|||1.13|-0.9659|0.8778
70856964|NCT02446743|141200497|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|vaccine group ratio of GMTs|1.7|||||TWO_SIDED|95.0|1.27|2.28|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||2.28|1.27|
71087037|NCT02456727|141680126|SUPERIORITY||Mean Difference (Net)|0.3623|STANDARD_ERROR_OF_MEAN|0.6252||0.5626|TWO_SIDED|95.0|-0.8667|1.5912|||ANCOVA|The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).|||1.5912|-0.8667|0.5626
71087038|NCT02456727|141680127|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0362|STANDARD_ERROR_OF_MEAN|0.0399||0.05|TWO_SIDED|95.0|-0.0419|0.1144|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=2) at 12 weeks between two treatment arms (Individual-Group)|||0.1144|-0.0419|0.05
71087039|NCT02456727|141680128|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0647|STANDARD_ERROR_OF_MEAN|0.0466||0.22|TWO_SIDED|95.0|-0.0266|0.156|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=2) at 12 weeks between two treatment arms (Individual-Group)|||0.156|-0.0266|0.22
71087040|NCT02456727|141680129|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0523|STANDARD_ERROR_OF_MEAN|0.0415||0.12|TWO_SIDED|95.0|-0.029|0.1335|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=2) at 24 weeks between two treatment arms (Individual-Group)|||0.1335|-0.029|0.12
71087041|NCT02456727|141680130|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0928|STANDARD_ERROR_OF_MEAN|0.0498||0.44|TWO_SIDED|95.0|-0.0047|0.1903|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=2) at 24 weeks between two treatment arms (Individual-Group)|||0.1903|-0.0047|0.44
71087042|NCT02456727|141680131|SUPERIORITY||Mean Difference (Net)|0.4831|STANDARD_ERROR_OF_MEAN|0.5753||0.4014|TWO_SIDED|95.0|-0.6468|1.6129|||ANCOVA|The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).|||1.6129|-0.6468|0.4014
71124579|NCT00574548|141755031|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.41|0.69|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 9V: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.69|0.41|
71124580|NCT00574548|141755031|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.75|1.15|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 14: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.15|0.75|
71124581|NCT00574548|141755031|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.58|0.85|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 18C: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.85|0.58|
71124582|NCT00574548|141755031|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.58|0.74|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 19A: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.74|0.58|
71124583|NCT00574548|141755031|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.89|1.39|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 19F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.39|0.89|
71124584|NCT00574548|141755031|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.5|0.73|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 23F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.73|0.50|
70856965|NCT02446743|141200497|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group ratio of GMTs|1.26|||||TWO_SIDED|95.0|0.94|1.68|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||1.68|0.94|
70856966|NCT02446743|141200497|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|vaccine group ratio of GMTs|1.32|||||TWO_SIDED|95.0|0.85|2.05|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||2.05|0.85|
70856967|NCT02446743|141200497|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|vaccine group ratio of GMTs|1.2|||||TWO_SIDED|95.0|0.81|1.78|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||1.78|0.81|
70856968|NCT02446743|141200502|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|13.0|||||TWO_SIDED|95.0|8.0|21.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||21.6|8.0|
71087043|NCT02456727|141680132|SUPERIORITY||Mean Difference (Net)|0.6617|STANDARD_ERROR_OF_MEAN|0.647||0.307|TWO_SIDED|95.0|-0.61|1.9334|||ANCOVA|The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).|||1.9334|-0.61|0.307
71087044|NCT02456727|141680133|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0159|STANDARD_ERROR_OF_MEAN|0.0364||0.01|TWO_SIDED|95.0|-0.0555|0.0873|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=5) at 12 weeks between two treatment arms (Individual-Group)|||0.0873|-0.0555|0.01
70856969|NCT02446743|141200502|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|16.0|||||TWO_SIDED|95.0|10.8|23.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||23.1|10.8|
70856970|NCT02446743|141200502|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|15.0|||||TWO_SIDED|95.0|11.0|20.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||20.1|11.0|
70856971|NCT02446743|141200502|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|54.0|||||TWO_SIDED|95.0|43.0|63.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||63.3|43.0|
70856972|NCT02446743|141200502|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|31.0|||||TWO_SIDED|95.0|22.0|40.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||40.1|22.0|
70856973|NCT02446743|141200502|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|41.0|||||TWO_SIDED|95.0|33.6|47.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||47.2|33.6|
70856974|NCT02446743|141200503|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|20.0|||||TWO_SIDED|95.0|15.0|25.4|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||25.4|15.0|
70856975|NCT02446743|141200503|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|18.0|||||TWO_SIDED|95.0|10.7|27.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||27.0|10.7|
70856976|NCT02446743|141200503|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|21.0|||||TWO_SIDED|95.0|15.6|28.8|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||28.8|15.6|
70856977|NCT02446743|141200503|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|12.0|||||TWO_SIDED|95.0|8.0|16.8|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||16.8|8.0|
71124585|NCT00574548|141755032|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.7|||||TWO_SIDED|95.0|2.03|3.55|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 1: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.55|2.03|
70856978|NCT02446743|141200503|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|20.0|||||TWO_SIDED|95.0|12.8|28.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||28.6|12.8|
70856979|NCT02446743|141200503|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|6.0|||||TWO_SIDED|95.0|1.5|12.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||12.2|1.5|
71124586|NCT00574548|141755032|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.18|1.89|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 3: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.89|1.18|
71124587|NCT00574548|141755032|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.7|||||TWO_SIDED|95.0|2.07|3.55|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 4: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.55|2.07|
71124588|NCT00574548|141755032|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.5|||||TWO_SIDED|95.0|1.77|3.61|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 5: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.61|1.77|
71124589|NCT00574548|141755032|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.7|||||TWO_SIDED|95.0|1.94|3.88|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 6B: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.88|1.94|
71124590|NCT00574548|141755032|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|8.5|||||TWO_SIDED|95.0|5.68|12.6|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 7F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||12.60|5.68|
71124591|NCT00574548|141755032|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|6.7|||||TWO_SIDED|95.0|4.45|10.22|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 9V: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||10.22|4.45|
71124592|NCT00574548|141755032|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.02|2.18|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 14: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.18|1.02|
71124593|NCT00574548|141755032|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.8|||||TWO_SIDED|95.0|2.01|3.89|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 18C: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.89|2.01|
71124594|NCT00574548|141755032|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.5|||||TWO_SIDED|95.0|1.92|3.13|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 19A: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.13|1.92|
71124595|NCT00574548|141755032|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.5|||||TWO_SIDED|95.0|1.8|3.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 19F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.44|1.80|
71124596|NCT00574548|141755032|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.9|||||TWO_SIDED|95.0|1.92|4.28|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 23F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||4.28|1.92|
71124597|NCT00903331|141755052|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.9631|TWO_SIDED|95.0|-0.09|0.08|||Wilcoxon Rank Sum|||The null hypothesis was that there was no difference between ACT-064922 and placebo for the change in FVC from baseline to the end of Period 1. The aim was to detect a placebo-corrected change in FVC of ≥ 0.1 L (Standard Deviation = 0.2 L) at a two-sided 0.05 type 1 error level and 80% power.||0.08|-0.09|0.9631
71124598|NCT00903331|141755053|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.118||||0.7056|TWO_SIDED|95.0|0.626|1.996|||Log Rank|||||1.996|0.626|0.7056
71124599|NCT00257660|141755075|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-8.84|||<|0.0001|TWO_SIDED|95.0|-12.94|-4.74||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline TWSTRS score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|"Baseline TWSTRS total scores are analysed for all subjects of ITT population, while the analysis at Week 4 excludes the scores for the 7 subjects who were not assessed.~Mean difference = difference in adjusted least squares mean (Dysport - Placebo)."|||-4.74|-12.94|<0.0001
71124600|NCT00257660|141755076|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-8.81|||<|0.0001||95.0|-12.91|-4.71||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline TWSTRS score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|"Baseline TWSTRS total scores are analysed for all subjects of ITT population, while the Week 8 analysis excludes the scores for the 24 subjects who were not assessed.~Mean difference = difference in adjusted least squares mean (Dysport - Placebo)."|||-4.71|-12.91|<0.0001
71124601|NCT00257660|141755077|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.12||||0.019||95.0|-7.55|-0.68||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline TWSTRS score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|"Baseline TWSTRS total scores are analysed for all subjects of ITT population, while the Week 12 analysis excludes the scores for the 27 subjects who were not assessed.~Mean difference = difference in adjusted least squares mean (Dysport - Placebo)."|||-0.68|-7.55|0.019
71124602|NCT00257660|141755078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-15.2|||<|0.001||95.0|-24.0|-6.4||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline Subject VAS symptom score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 4) excludes 4 subjects (and 13 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||-6.4|-24.0|<0.001
70856980|NCT02446743|141200504|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|27.0|||||TWO_SIDED|95.0|21.9|33.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||33.3|21.9|
70945334|NCT01475461|141391159|SUPERIORITY_OR_OTHER||LS Mean Difference|0.76|STANDARD_ERROR_OF_MEAN|0.449||0.0913|TWO_SIDED|80.0|0.18|1.34||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80 percent (%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.34|0.18|0.0913
71124603|NCT00257660|141755079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-14.2|||<|0.001||95.0|-22.3|-6.1||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline Investigator VAS CD symptom score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 4) excludes 3 subjects (and 8 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||-6.1|-22.3|<0.001
71124604|NCT00257660|141755080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-16.95|||<|0.001||95.0|-25.8|-8.1||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline Subject VAS Pain score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 8) excludes 4 subjects (and 4 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||-8.1|-25.8|<0.001
70945335|NCT01475461|141391159|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.461||0.5236|TWO_SIDED|80.0|-0.3|0.89||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.89|-0.30|0.5236
70856981|NCT02446743|141200504|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|31.0|||||TWO_SIDED|95.0|21.8|40.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||40.3|21.8|
71124605|NCT00257660|141755081|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-16.0|||<|0.001||95.0|-24.2|-7.8||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline Investigator VAS Pain score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 8) excludes 3 subjects (and 3 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||-7.8|-24.2|<0.001
71124606|NCT00257660|141755082|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-11.05||||0.007||95.0|-19.0|-3.1||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline Subject VAS Pain score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 12) excludes 4 subjects (and 4 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||-3.1|-19.0|0.007
71124607|NCT00257660|141755083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.05||||0.028||95.0|-13.3|-0.8||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline Investigator VAS Pain score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 12) excludes 3 subjects (and 3 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||-0.8|-13.3|0.028
71124608|NCT00257660|141755084|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.65||||0.061||95.0|-0.17|7.47||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline SF-36 mental health summary score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 8) excludes 3 subjects (and 37 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||7.47|-0.17|0.061
71124609|NCT00257660|141755085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.66||||0.002||95.0|1.73|7.58||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline SF-36 physical health summary score, center and previous treatment by botulinum toxin or not were fitted in ANCOVA model.|Analysis at baseline (and on change at Week 8) excludes 3 subjects (and 37 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||7.58|1.73|0.002
71124610|NCT00257660|141755086|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|7.206|||<|0.0001||95.0|3.01|17.26||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|odds ratio|The odds ratio represents the odds of success on Dysport versus Placebo stratified for strata and country||The number of participants considered treatment successes was analysed using a logistic model with treatment, strata (naive or non-naive) and center as factors in the model.||17.26|3.01|<0.0001
71124611|NCT02449018|141755089|SUPERIORITY||Mean Difference (Net)|0.28|STANDARD_DEVIATION|0.31||0.13|TWO_SIDED|90.0|-0.24|0.79|||ANCOVA|||||0.79|-0.24|0.130
71124612|NCT03426631|141755104|SUPERIORITY||Median Difference (Final Values)|-11.7||||0.47|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.47
71124613|NCT04971941|141755113|SUPERIORITY||Mean Difference (Final Values)|1.7|STANDARD_DEVIATION|2.17||0.001|TWO_SIDED|95.0|0.4|2.1||This P value applies to comparison of IAN with and without DentalVibe|t-test, 2 sided|df =58||Sample size estimation from Nanitsos 2010: Using the P value from the paired T test with 61 degrees of freedom the T statistic calculated at 4.365. From mean difference 9.3 SD was calculated as 16.66 for an effect size of 0.558. This generated a sample size of 44 subjects, receiving 2 injections (1 with DV3 and 1 without), is necessary to attain 95% power for a paired t-test comparing the 2 pain measures at a two-tailed alpha level of 0.05. P value for IAN||2.1|0.4|0.001
71124614|NCT04971941|141755113|SUPERIORITY||Mean Difference (Final Values)|-1.6|STANDARD_DEVIATION|1.75||0.02|TWO_SIDED|95.0|-1.7|-1.5|||t-test, 2 sided|df= 58||||-1.5|-1.7|0.02
71124615|NCT04971941|141755113|SUPERIORITY||Mean Difference (Net)|1.2|STANDARD_DEVIATION|1.74||0.004|TWO_SIDED|95.0|0.4|2.1|||t-test, 2 sided|||||2.1|0.4|0.004
71124616|NCT04971941|141755114|SUPERIORITY||Mean Difference (Net)|4.0||||0.001|TWO_SIDED|14.0|0.4|4.8||This P value applies to comparing IAN with or with DV as measured by SSI tolerability/ability to endure|t-test, 2 sided|||||4.8|0.4|0.001
71124617|NCT04971941|141755114|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
71124618|NCT04971941|141755114|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
71124619|NCT04971941|141755114|SUPERIORITY|||||||0.058|||||||t-test, 2 sided|||||||0.058
70945336|NCT01475461|141391159|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.447||0.9244|TWO_SIDED|80.0|-0.53|0.62||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.62|-0.53|0.9244
71124620|NCT04971941|141755114|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||0.008
71124621|NCT04971941|141755114|SUPERIORITY|||||||0.044|||||||t-test, 2 sided|||||||0.044
71124622|NCT04971941|141755114|SUPERIORITY|||||||0.023|||||||t-test, 2 sided|||||||0.023
71124623|NCT04971941|141755114|SUPERIORITY|||||||0.042|||||||t-test, 2 sided|||||||0.042
71124624|NCT04971941|141755114|SUPERIORITY|||||||0.053|||||||t-test, 2 sided|||||||0.053
71124625|NCT04971941|141755115|SUPERIORITY|||||||0.459|||||||t-test, 2 sided|||The null hypothesis is that there is no relation between use of DV and numb times. There were no studies from which to perform a power calculation for this outcome measure||||0.459
71124626|NCT01561963|141755181|EQUIVALENCE|No statistically significant interaction between apremilast and rifampicin was confirmed if both the upper and lower 90% confidence interval (CI) limits for the geometric least squares mean ratios of apremilast administered with rifampicin to apremilast alone fell within the no effect boundary of 80% to 125%.|Ratio of Geometric Least Squares Means|96.35|||||TWO_SIDED|90.0|88.56|104.82|||||Apremilast + IV Rifampin / Apremilast Alone|The effect of rifampicin on the PK of apremilast was evaluated using a linear mixed effect analysis of variance on the log-transformed values of AUCt of apremilast, to estimate the mean ratio of apremilast administered with and without rifampicin treatment. The model included treatment as fixed effect, and subject as a random effect.||104.82|88.56|
71124627|NCT01561963|141755181|EQUIVALENCE|No statistically significant interaction between apremilast and rifampicin was confirmed if both the upper and lower 90% CI limits for the geometric least squares mean ratios of apremilast administered with rifampicin to apremilast alone fell within the no effect boundary of 80% to 125%.|Ratio of Geometric Least Squares Means|27.88|||||TWO_SIDED|90.0|25.63|30.34|||||Apremilast + Multiple Dose Oral Rifampin / Apremilast Alone|The effect of rifampicin on the PK of apremilast was evaluated using a linear mixed effect analysis of variance on the log-transformed values of AUCt of apremilast, to estimate the mean ratio of apremilast administered with and without rifampicin treatment. The model included treatment as fixed effect, and subject as a random effect.||30.34|25.63|
70945337|NCT01475461|141391159|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.452||0.5066|TWO_SIDED|80.0|-0.28|0.88||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.88|-0.28|0.5066
71124628|NCT01561963|141755182|EQUIVALENCE|No statistically significant interaction between apremilast and rifampicin was confirmed if both the upper and lower 90% CI limits for the geometric least squares mean ratios of apremilast administered with rifampicin to apremilast alone fell within the no effect boundary of 80% to 125%.|Ratio of Geometric Least Squares Means|95.71|||||TWO_SIDED|90.0|87.99|104.12|||||Apremilast + IV Rifampin / Apremilast Alone|The effect of rifampicin on the PK of apremilast was evaluated using a linear mixed effect analysis of variance on the log-transformed values of AUC∞ of apremilast, to estimate the mean ratio of apremilast administered with and without rifampicin treatment. The model included treatment as fixed effect, and subject as a random effect.||104.12|87.99|
71124629|NCT01561963|141755182|EQUIVALENCE|No statistically significant interaction between apremilast and rifampicin was confirmed if both the upper and lower 90% CI limits for the geometric least squares mean ratios of apremilast administered with rifampicin to apremilast alone fell within the no effect boundary of 80% to 125%.|Ratio of Geometric Least Squares Means|27.96|||||TWO_SIDED|90.0|25.7|30.41|||||Apremilast + Multiple Dose Oral Rifampin / Apremilast Alone|The effect of rifampicin on the PK of apremilast was evaluated using a linear mixed effect analysis of variance on the log-transformed values of AUC∞ of apremilast, to estimate the mean ratio of apremilast administered with and without rifampicin treatment. The model included treatment as fixed effect, and subject as a random effect.||30.41|25.70|
71124630|NCT01561963|141755183|EQUIVALENCE|No statistically significant interaction between apremilast and rifampicin was confirmed if both the upper and lower 90% CI limits for the geometric least squares mean ratios of apremilast administered with rifampicin to apremilast alone fell within the no effect boundary of 80% to 125%.|Ratio of Geometric Least Squares Means|113.07|||||TWO_SIDED|90.0|103.18|123.91|||||Apremilast + IV Rifampin / Apremilast Alone|The effect of rifampicin on the PK of apremilast was evaluated using a linear mixed effect analysis of variance on the log-transformed values of Cmax of apremilast, to estimate the mean ratio of apremilast administered with and without rifampicin treatment. The model included treatment as fixed effect, and subject as a random effect.||123.91|103.18|
71087045|NCT02456727|141680134|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0287|STANDARD_ERROR_OF_MEAN|0.0424||0.05|TWO_SIDED|95.0|-0.0544|0.1117|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=5) at 12 weeks between two treatment arms (Individual-Group)|||0.1117|-0.0544|0.05
71087046|NCT02456727|141680135|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0389|STANDARD_ERROR_OF_MEAN|0.0369||0.05|TWO_SIDED|95.0|-0.0335|0.1112|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=5) at 24 weeks between two treatment arms (Individual-Group)|||0.1112|-0.0335|0.05
71087047|NCT02456727|141680136|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0608|STANDARD_ERROR_OF_MEAN|0.0436||0.18|TWO_SIDED|95.0|-0.0247|0.1463|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=5) at 24 weeks between two treatment arms (Individual-Group)|||0.1463|-0.0247|0.18
71087048|NCT02456727|141680137|OTHER|The null hypothesis is that there is no change in the proportion of participants with self-reported opioid prescription comparing 12 weeks vs baseline.||||||0.1658|||||||McNemar|||Two treatment arms are combined as one group to compare the outcome of interest pre- and post-randomization.||||0.1658
71087049|NCT02456727|141680138|OTHER|The null hypothesis is that there is no change in the proportion of participants with self-reported opioid prescription comparing 12 weeks vs baseline.||||||0.1172|||||||McNemar|||Two treatment arms are combined as one group to compare the outcome of interest pre- and post-randomization.||||0.1172
71087050|NCT02456727|141680139|OTHER|The null hypothesis is that there is no change in the days of self-reported opioid medication use comparing 12 weeks vs baseline.||||||0.0326|||||||Wilcoxon signed rank test|||Two treatment arms are combined as one group to compare the outcome of interest prior- and post-randomization.||||0.0326
70856982|NCT02446743|141200504|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|26.0|||||TWO_SIDED|95.0|19.2|33.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||33.1|19.2|
71087051|NCT02456727|141680140|OTHER|The null hypothesis is that there is no change in the days of self-reported opioid medication use comparing 12 weeks vs baseline.||||||0.0026|||||||Wilcoxon signed rank test|||Two treatment arms are combined as one group to compare the outcome of interest prior- and post-randomization.||||0.0026
71087052|NCT02456727|141680141|SUPERIORITY|||||||0.129||||||The change in MME was not normally distributed, thus we report median and IQR rather than mean/standard deviation. We employed Mann-Whitney to assess whether the change in MME between pre- and post-treatment periods differed across intervention arms.|Wilcoxon (Mann-Whitney)|||||||0.129
71087053|NCT02456727|141680142|SUPERIORITY|||||||0.031||||||The change in MME was not normally distributed, thus we report median and IQR rather than mean/standard deviation. We employed Mann-Whitney to assess whether the change in MME between pre- and post-treatment periods differed across intervention arms.|Wilcoxon (Mann-Whitney)|||||||0.031
71087054|NCT02456727|141680143|SUPERIORITY|Difference in change in proportion pre and post-treatment differs by treatment arm.||||||0.0059|||||||Mixed Models Analysis|||||||0.0059
71087055|NCT02456727|141680144|SUPERIORITY|||||||0.0385|||||||Mixed Models Analysis|||||||0.0385
71087056|NCT01663402|141680184|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0003|TWO_SIDED|95.0|0.78|0.93||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world).||0.93|0.78|0.0003
71087057|NCT01663402|141680185|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.0013|TWO_SIDED|95.0|0.81|0.95||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region(North America,South America,Western Europe,Eastern Europe,Asia, Rest of the world).A hierarchical testing approach was used to control the overall type-I error at 0.0249 one-sided alpha level(0.0498 two-sided).Testing was then performed sequentially in the order endpoints were reported.Hierarchical testing sequence continued only if the previous endpoint was statistically significant.||0.95|0.81|0.0013
71087058|NCT01663402|141680186|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.006|TWO_SIDED|95.0|0.8|0.96||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world). Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).||0.96|0.80|0.0060
71087059|NCT01663402|141680187|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.0003|TWO_SIDED|95.0|0.81|0.94||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world). Testing according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).||0.94|0.81|0.0003
71087060|NCT01663402|141680188|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0003|TWO_SIDED|95.0|0.79|0.93||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world). Testing according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).||0.93|0.79|0.0003
71087061|NCT01663402|141680189|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.3824|TWO_SIDED|95.0|0.76|1.11||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world). Testing according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).||1.11|0.76|0.3824
71124631|NCT01561963|141755183|EQUIVALENCE|No statistically significant interaction between apremilast and rifampicin was confirmed if both the upper and lower 90% CI limits for the geometric least squares mean ratios of apremilast administered with rifampicin to apremilast alone fell within the no effect boundary of 80% to 125%.|Ratio of Geometric Least Squares Means|56.8|||||TWO_SIDED|90.0|51.84|62.25|||||Apremilast + Multiple Dose Oral Rifampin / Apremilast Alone|The effect of rifampicin on the PK of apremilast was evaluated using a linear mixed effect analysis of variance on the log-transformed values of Cmax of apremilast, to estimate the mean ratio of apremilast administered with and without rifampicin treatment. The model included treatment as fixed effect, and subject as a random effect.||62.25|51.84|
71124632|NCT01561963|141755184|OTHER||Median Difference|-0.25||||0.2656|TWO_SIDED|90.0|-0.75|0.0|||Wilcoxon signed rank test||Apremilast + IV Rifampin - Apremilast Alone|Tmax was analyzed using nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||0.00|-0.75|0.2656
71124633|NCT01561963|141755184|OTHER||Median Difference|-0.5||||0.1141|TWO_SIDED|90.0|-1.0|0.0|||Wilcoxon signed rank test||Apremilast + Multiple Dose Oral Rifampin - Apremilast Alone|Tmax was analyzed using nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||0.00|-1.00|0.1141
71124634|NCT02530996|141755226|OTHER|Power calculations were performed using G\*Power computer software version 3. Sample-size calculations were based on the number of patients needed to detect significant differences in FMD between placebo and BH4.|Mean Difference (Net)|1.5|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Statistics were performed using SPSS software (IBM, Chicago, IL). Paired t-tests were used to identify significant changes in measured variables between placebo and BH4. Unpaired t-tests were used to identify significant changes in measured variables between ordered groups. Based on data published in PMID: 25511849 power calculations for this study of SSc patients were made.||||<0.05
71124635|NCT04268745|141755237|SUPERIORITY||Mean Difference (Final Values)|-13.603||||0.027|TWO_SIDED|95.0|-25.634|-1.573|||Regression, Linear|||||-1.573|-25.634|0.027
71124636|NCT04268745|141755238|SUPERIORITY||Median Difference (Final Values)|6.405||||0.0001|TWO_SIDED|95.0|4.474|8.335|||Regression, Linear|||||8.335|4.474|0.0001
71124637|NCT04268745|141755239|SUPERIORITY||Mean Difference (Final Values)|-18.703||||0.0002|TWO_SIDED|95.0|-28.235|-9.172|||Regression, Linear|||||-9.172|-28.235|0.0002
71124638|NCT04268745|141755240|SUPERIORITY||Mean Difference (Final Values)|8.556||||0.028|TWO_SIDED|95.0|0.938|16.174|||Regression, Linear|||||16.174|0.938|0.028
71124639|NCT04268745|141755241|SUPERIORITY||Mean Difference (Final Values)|0.111||||0.695|TWO_SIDED|95.0|-0.443|0.665|||Regression, Linear|||||0.665|-0.443|0.695
71124640|NCT04268745|141755242|SUPERIORITY||Mean Difference (Final Values)|-0.514||||0.469|TWO_SIDED|95.0|-1.901|0.874|||Regression, Linear|||||0.874|-1.901|0.469
71124641|NCT03907033|141755260|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm for Hydrocodone use||||1.000
71124642|NCT03907033|141755260|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm for Oxycodone use||||0.010
71124643|NCT03907033|141755261|SUPERIORITY|||||||0.248|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm for Ibuprofen use||||0.248
71124644|NCT03907033|141755261|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm for Tylenol use||||1.000
71124645|NCT03907033|141755263|SUPERIORITY|||||||0.846|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm 24 hours post-surgery||||0.846
71124646|NCT03907033|141755263|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm 48 hours post-surgery||||0.490
71124647|NCT03907033|141755263|SUPERIORITY|||||||0.564|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm 72 hours post-surgery||||0.564
71124648|NCT03907033|141755264|SUPERIORITY|||||||0.264|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine arm at 24 hours post-surgery||||0.264
71124649|NCT03907033|141755264|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine arm at 48 hours post-surgery||||0.970
71124650|NCT03907033|141755264|SUPERIORITY|||||||0.536|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine arm at 72 hours post-surgery||||0.536
71124651|NCT03907033|141755265|SUPERIORITY|||||||0.957|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm at 24 hours post-surgery||||0.957
71124652|NCT03907033|141755265|SUPERIORITY|||||||0.353|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm at 48 hours post-surgery||||0.353
71124653|NCT03907033|141755265|SUPERIORITY|||||||0.165|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm at 72 hours post-surgery||||0.165
71124654|NCT03907033|141755267|SUPERIORITY|||||||0.802|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm at 72 hours post-surgery||||0.802
70856983|NCT02446743|141200504|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|19.0|||||TWO_SIDED|95.0|14.3|24.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||24.3|14.3|
70856984|NCT02446743|141200504|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|19.0|||||TWO_SIDED|95.0|12.1|27.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||27.5|12.1|
71124655|NCT03907033|141755267|SUPERIORITY|||||||0.656|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm at 7-10 days post-surgery||||0.656
71124656|NCT01174173|141755269|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||A two-sided t-test was performed with p-value \< 0.05 was considered statistically significant a priori.|t-test, 2 sided|||||||0.0013
71124657|NCT01174173|141755270|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED|||||A two-sided t-test was performed for change in 6-minute walk test and p-value \< 0.05 was considered statistically significant a priori.|t-test, 2 sided|||||||0.09
71124658|NCT01174173|141755271|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED|||||A two-sided t-test was performed for difference from baseline and 3-month KCCQ score. A p-value of \<0.05 was considered statistically significant a priori.|t-test, 2 sided|||||||0.37
71124659|NCT01174173|141755273|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||t-test, 2 sided|||||||0.037
71124660|NCT01174173|141755274|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||t-test, 2 sided|||||||0.66
71124661|NCT02408523|141755277|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.001|TWO_SIDED|95.0|0.377|0.774||Wald's method was used to calculate the p-value, Hazard Ratio (HR) and confidence intervals (CIs).|Regression, Cox|||Comparison of LCM versus Placebo was based on a Cox proportional hazards regression model with an effect for treatment, stratifying for the following combinations of study participants' Baseline PGTCS frequency and Development from interactive response technology (IRT) (\<= 2 per 28 days in the Combined Baseline Period and Pediatric, \<= 2 per 28 days in the Combined Baseline Period and Adult, and \> 2 per 28 days in the Combined Baseline Period). The reference group was Placebo.||0.774|0.377|<0.001
71124662|NCT02408523|141755278|SUPERIORITY||KM seizure free of LCM vs Placebo|14.1|||=|0.011|TWO_SIDED|95.0|3.2|25.1||Superiority of LCM vs Placebo p-value was based on a chi-square test on 1 degree of freedom.|Mantel Haenszel||Stratified difference in proportion of subjects who are seizure-free from PGTCS on Lacosamide (FAS) vs Placebo (FAS).|The key secondary efficacy variable was evaluated using an extended Mantel-Haenszel testing procedure. Baseline PGTCS Frequency from Combined Baseline and development (age from interactive response technology (IRT)) were calculated from IRT.||25.1|3.2|=0.011
70856985|NCT02446743|141200504|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|19.0|||||TWO_SIDED|95.0|13.3|26.4|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||26.4|13.3|
70856986|NCT02446743|141200504|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|43.0|||||TWO_SIDED|95.0|35.2|49.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||49.9|35.2|
71087062|NCT03575702|141680202|NON_INFERIORITY|The non-inferiority margin is considered as change in mean daily urination episodes of 0,8 episodes per day|Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.34|=|0.5595|ONE_SIDED|95.0||0.38|||ANCOVA|The number of urination episodes at the initiation of therapy is used as covariate, and the therapy group is used as a factor.||"The null hypothesis is that effect of Urotol according to the assessment of mean daily urination episodes exceeds effect of Uritos.~A sample containing of 222 patients (111 per study group) is considered sufficient to prove the alternative hypothesis at the significance level 0.025% and study power 80%. Given the expected drop out rate during the treatment period, the total number of patients to be randomized is 300 (150 in each group)."||0.38||=0.5595
71087063|NCT03575702|141680203|OTHER||||||=|0.0008|||||||ANCOVA|||||||=0.0008
71087064|NCT03575702|141680204|OTHER||||||=|0.0099|||||||ANCOVA|||||||=0.0099
71087065|NCT03575702|141680205|OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71087066|NCT03575702|141680206|OTHER||||||<|0.0001|||||||ANCOVA|Changes in number of daily incontinence episodes - week 2||||||<0.0001
71087067|NCT03575702|141680206|OTHER||||||=|0.0236|||||||ANCOVA|Changes in number of daily incontinence episodes - week 4||||||=0.0236
71087068|NCT03575702|141680206|OTHER||||||<|0.0001|||||||ANCOVA|Changes in number of daily incontinence episodes - week 8||||||<0.0001
71087069|NCT03575702|141680206|OTHER||||||=|0.0018|||||||ANCOVA|Changes in daytime number of daily incontinence episodes - week 2||||||=0.0018
71087070|NCT03575702|141680206|OTHER||||||=|0.3835|||||||ANCOVA|Changes in daytime number of daily incontinence episodes - week 4||||||=0.3835
71087071|NCT03575702|141680206|OTHER||||||=|0.0088|||||||ANCOVA|Changes in daytime number of daily incontinence episodes - week 8||||||=0.0088
71087072|NCT03575702|141680206|OTHER||||||=|0.0004|||||||ANCOVA|Changes in nighttime number of daily incontinence episodes - week 2||||||=0.0004
71087073|NCT03575702|141680206|OTHER||||||<|0.0001|||||||ANCOVA|Changes in nighttime number of daily incontinence episodes - week 4||||||<0.0001
71087074|NCT03575702|141680206|OTHER||||||<|0.0001|||||||ANCOVA|Changes in nighttime number of daily incontinence episodes - week 8||||||<0.0001
71087075|NCT03575702|141680207|OTHER|||||||0.0008|||||||ANCOVA|||||||0.0008
71087076|NCT03575702|141680208|OTHER||||||=|0.1348|||||||ANCOVA|Week 2 changes||||||=0.1348
71087077|NCT03575702|141680208|OTHER||||||=|0.3199|||||||ANCOVA|Week 4 changes||||||=0.3199
71087078|NCT03575702|141680208|OTHER||||||=|0.9537|||||||ANCOVA|Week 8 changes||||||=0.9537
71087079|NCT03575702|141680209|OTHER||||||=|0.5321|||||||t-test, 1 sided|Change week 12||||||=0.5321
71087080|NCT03575702|141680210|OTHER||||||=|0.4839|||||||t-test, 1 sided|Change week 12||||||=0.4839
71087081|NCT03575702|141680211|OTHER||||||=|0.86|||||||Chi-squared|||||||=0.86
71087082|NCT01255163|141680217|OTHER|||||||0.016||||||threshold for significance (p \< 0.05)|Fisher Exact|||||||0.016
71087083|NCT01255163|141680218|OTHER|||||||0.098||||||"Threshold for statistical significance p \< 0.05.~Type III Tests of Fixed Effects Group \* VisitLong F (6, 52.008) = 1.902, p = 0.098"|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED MMSE.tot BY Group Sex VisitLong WITH Age~* CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE)~* FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3)~* METHOD=REML~* PRINT=SOLUTION~* REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1)~* EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI)~* EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI)~* EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI)~* EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.098
71087084|NCT01255163|141680219|OTHER|||||||0.295||||||"Threshold for statistical significance p \< 0.05.~Type III Tests of Fixed Effects for Group\*VisitLong F (6, 52.281) = 1.254, p = 0.295"|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED ADAS70 BY Group Sex VisitLong WITH Age~* CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE)~* FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3)~* METHOD=REML~* PRINT=SOLUTION~* REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1)~* EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI)~* EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI)~* EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI)~* EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.295
71087085|NCT01255163|141680220|OTHER|||||||0.141||||||Threshold for statistical significance p \< 0.05. Type III Tests of Fixed Effects Group \* VisitLong F (6, 47.485) = 1.704, p = 0.141|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED CDR BY Group Sex VisitLong WITH Age~CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.141
70945338|NCT01475461|141391159|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.449||0.8947|TWO_SIDED|80.0|-0.64|0.52||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.52|-0.64|0.8947
70945339|NCT01475461|141391159|SUPERIORITY_OR_OTHER||LS Mean Difference|0.91|STANDARD_ERROR_OF_MEAN|0.478||0.0577|TWO_SIDED|80.0|0.3|1.52||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.52|0.30|0.0577
71087086|NCT01255163|141680221|OTHER|||||||0.031||||||Threshold for statistical significance p \< 0.05. Type III Tests of Fixed Effects: Group \* VisitLong F (6, 51.955) = 2.553, p = 0.031. Univarate Exendin-4 F(3, 51.386) = 2.734, p = 0.053. Pairwise for Exendin-4, baseline vs. 18 months (p = 0.035).|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED CDR.sob BY Group Sex VisitLong WITH Age CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.031
71087087|NCT01255163|141680222|OTHER|||||||0.703||||||Threshold for statistical significance p \< 0.05. Type III Tests of Fixed Effects Group \* VisitLong F (2, 15.251) = 0.360, p = 0.703.|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline,18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED TAU BY Group Sex VisitLong WITH Age CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.703
71087088|NCT01255163|141680223|OTHER|||||||0.845||||||Threshold for statistical significance p \< 0.05. Type III Tests of Fixed Effects Group \* VisitLong F (2, 15.828) = 0.170, p = 0.845.|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline,18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED pTAU BY Group Sex VisitLong WITH Age CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.845
71087089|NCT01255163|141680224|OTHER|||||||0.018||||||Type III Tests of Fixed Effects: Group \* VisitLong F (2, 16.614) = 5.142, p = 0.018. Univariate tests: Placebo F(1, 16.595) = 4.138, p = 0.058; Exendin-4 F(1, 16.595) = 6.262, p = 0.022. Pairwise for Exendin-4, baseline vs. 18 months (p = 0.022).|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline,18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED Ab42 BY Group Sex VisitLong WITH Age CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.018
71087090|NCT01255163|141680225|OTHER|||||||0.009||||||Type III Tests of Fixed Effects: Group \* VisitLong F (8, 72.603) = 2.816, p = 0.009. Univarate Exendin-4 F(4, 72.944) = 4.834, p = 0.002. Pairwise comparisons for Exendin-4 showed a decrease in BMI baseline vs. 6 months (p = 0.029).|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED BMI BY Group Sex VisitLong WITH Age CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.009
71087091|NCT02495389|141680227|SUPERIORITY||Mean Difference (Final Values)|23.96|STANDARD_ERROR_OF_MEAN|2.7741|<|0.0001|TWO_SIDED|95.0|18.35|29.57|||t-test, 2 sided|A two-sided paired t-test was used for this analysis.||The null hypothesis is that there is no change in patients' baseline Overactive Bladder Questionnaire (OAB-q) Health Related Quality of Life (HRQL) score after 12 weeks of therapy.||29.57|18.35|<.0001
71087092|NCT02495389|141680228|SUPERIORITY||Mean Difference (Final Values)|-51.62|STANDARD_ERROR_OF_MEAN|6.1584|<|0.0001|TWO_SIDED|95.0|-64.04|-39.2|||t-test, 2 sided|A two-sided paired t-test was used for this analysis.||The null hypothesis is that there is no change in patients' baseline Urinary Distress Inventory score after 12 weeks of therapy.||-39.20|-64.04|<.0001
71124663|NCT02408523|141755279|SUPERIORITY||Hazard Ratio (HR)|0.683|||=|0.012|TWO_SIDED|95.0|0.507|0.921||Wald's method was used to calculate the p-value, Hazard Ratio (HR) and confidence intervals (CIs).|Regression, Cox|||Comparison of LCM versus Placebo was based on a Cox proportional hazards regression model with an effect for treatment, stratifying for the following combinations of study participants' Baseline PGTCS frequency and Development from interactive response technology (IRT) (\<= 2 per 28 days in the Combined Baseline Period and Pediatric, \<= 2 per 28 days in the Combined Baseline Period and Adult, and \> 2 per 28 days in the Combined Baseline Period). The reference group was Placebo.||0.921|0.507|=0.012
70945340|NCT01475461|141391159|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|0.49||0.3012|TWO_SIDED|80.0|-0.12|1.14||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.14|-0.12|0.3012
71087093|NCT02495389|141680229|SUPERIORITY||Mean Difference (Final Values)|-29.3|STANDARD_ERROR_OF_MEAN|5.4701|<|0.0001|TWO_SIDED|95.0|-40.33|-18.27|||t-test, 2 sided|A two-sided paired t-test was used for this analysis.||The null hypothesis is that there is no change in patients' baseline Pelvic Organ Prolapse Distress Inventory score after 12 weeks of therapy.||-18.27|-40.33|<.0001
71087094|NCT02495389|141680230|SUPERIORITY||Mean Difference (Final Values)|-32.0|STANDARD_ERROR_OF_MEAN|6.1226|<|0.0001|TWO_SIDED|95.0|-44.35|-19.65|||t-test, 2 sided|A two-sided paired t-test was used for this analysis.||The null hypothesis is that there is no change in patients' baseline Colo-Rectal-Anal Distress Inventory score after 12 weeks of therapy.||-19.65|-44.35|<.0001
71087095|NCT03834493|141680245|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.6621|TWO_SIDED|95.0|0.88|1.22|||Log Rank||Stratified Cox model with Efron's tie handling method|||1.22|0.88|0.6621
71087096|NCT03834493|141680246|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.4073|TWO_SIDED|95.0|0.84|1.14|||Log Rank||Stratified Cox model with Efron's tie handling method|||1.14|0.84|0.4073
70856987|NCT02446743|141200504|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|58.0|||||TWO_SIDED|95.0|46.6|67.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||67.3|46.6|
70945341|NCT01475461|141391159|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.476||0.3165|TWO_SIDED|80.0|-0.13|1.09||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.09|-0.13|0.3165
71087097|NCT03834493|141680247|OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.83|1.09|||||Stratified Cox model with Efron's tie handling method|||1.09|0.83|
71087098|NCT03834493|141680248|OTHER||Difference in Percentage|3.4|||||TWO_SIDED|95.0|-1.5|8.3|||||Stratified Miettinen and Nurminen method|||8.3|-1.5|
71087099|NCT03834493|141680249|OTHER||Difference in Percentage|0.3|||||TWO_SIDED|95.0|-3.4|4.1|||||Stratified Miettinen and Nurminen method|||4.1|-3.4|
71087100|NCT03834493|141680250|OTHER||Difference in Percentage|2.9|||||TWO_SIDED|95.0|-0.2|6.1|||||Stratified Miettinen and Nurminen method|||6.1|-0.2|
71087101|NCT03834493|141680252|OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.86|1.15|||||Stratified Cox model with Efron's tie handling method|||1.15|0.86|
71087102|NCT03834493|141680253|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.74|1.09|||||Stratified Cox model with Efron's tie handling method|||1.09|0.74|
71087103|NCT03834493|141680254|OTHER||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.82|1.35|||||Stratified Cox model with Efron's tie handling method|||1.35|0.82|
71087104|NCT03834493|141680255|OTHER||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.85|1.51|||||Stratified Cox model with Efron's tie handling method|||1.51|0.85|
71087105|NCT05559905|141680258|SUPERIORITY||Difference in Least Squares Mean|-0.29||||0.578|TWO_SIDED|90.0|-1.16|0.58|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The mean PVL in each group and the differences in mean PVL between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||0.58|-1.16|0.578
71087106|NCT05559905|141680259|SUPERIORITY||Difference in Least Squares Mean|-2.69||||0.201|TWO_SIDED|90.0|-6.17|-0.79|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) were included in the model. For both panels, only the participants with RSV infection were included in the analysis. The mean VL-AUC in each group and the differences in mean VL-AUC between MK-4482 and placebo and the corresponding 2-sided 95% CI were computed based on the linear model.||-0.79|-6.17|0.201
71087107|NCT05559905|141680265|SUPERIORITY||Difference in Least Squares Mean|-0.62||||0.736|TWO_SIDED|90.0|-3.65|2.42|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The mean VL-AUC in each group and the differences in mean VL-AUC between MK-4482 and placebo and the corresponding 2-sided 95% CI were computed based on the linear model.||2.42|-3.65|0.736
71087108|NCT05559905|141680266|SUPERIORITY||Difference in Least Squares Mean|-1.93||||0.646|TWO_SIDED|90.0|-8.88|5.02|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The mean VL-AUC in each group and the differences in mean VL-AUC between MK-4482 and placebo and the corresponding 2-sided 95% CI were computed based on the linear model.||5.02|-8.88|0.646
71087109|NCT05559905|141680267|SUPERIORITY||Difference in Least Squares Mean|-0.14||||0.849|TWO_SIDED|90.0|-1.31|1.04|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The mean PVL in each group and the differences in mean PVL between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||1.04|-1.31|0.849
71087110|NCT05559905|141680268|SUPERIORITY||Difference in Least Squares Mean|-2.09||||0.371|TWO_SIDED|90.0|-5.97|1.78|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The TSS-AUC in each group and the differences in mean TSS-AUC between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||1.78|-5.97|0.371
71087111|NCT05559905|141680269|SUPERIORITY||Difference in Least Squares Mean|-1.82||||0.36|TWO_SIDED|90.0|-5.11|1.47|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The TSS-AUC-CFB in each group and the differences in mean TSS-AUC-CFB between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||1.47|-5.11|0.360
70856988|NCT02446743|141200504|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|33.0|||||TWO_SIDED|95.0|23.0|42.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||42.5|23.0|
71087112|NCT05559905|141680270|SUPERIORITY||Difference in Least Squares Mean|-0.46||||0.459|TWO_SIDED|90.0|-1.5|0.57|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The mean peak TSS in each group and the differences in mean peak TSS between MK-4482 and placebo and the corresponding 2- sided 95% CI was computed based on the linear model.||0.57|-1.50|0.459
71087113|NCT05559905|141680272|SUPERIORITY||Difference in Percent (%)|3.42|||||TWO_SIDED|95.0|-18.28|24.5||||||||24.50|-18.28|
71087114|NCT05559905|141680273|SUPERIORITY||Difference in Percent (%)|2.89|||||TWO_SIDED|95.0|-19.37|25.69||||||||25.69|-19.37|
71087115|NCT05559905|141680274|SUPERIORITY||Difference in Percent (%)|-2.63|||||TWO_SIDED|95.0|-25.07|19.91||||||||19.91|-25.07|
71087116|NCT05559905|141680275|SUPERIORITY||Difference in Percent (%)|-16.18|||||TWO_SIDED|95.0|-36.77|5.64||||||||5.64|-36.77|
71087117|NCT05559905|141680276|SUPERIORITY||Difference in Percent (%)|-2.89|||||TWO_SIDED|95.0|-25.69|19.37||||||||19.37|-25.69|
71087118|NCT05559905|141680277|SUPERIORITY||Difference in Least Squares Mean|-0.69||||0.253|TWO_SIDED|90.0|-1.68|0.31|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) are included in the model. For both panels, only the participants with RSV infection were included. The mean PVL in each group and the differences in mean PVL between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||0.31|-1.68|0.253
71087119|NCT05559905|141680278|SUPERIORITY||Hazard Ratio (HR)|1.72||||0.1708||95.0|0.83|3.57|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||3.57|0.83|0.1708
71087120|NCT05559905|141680279|SUPERIORITY||Difference in Least Squares Mean|-5.93||||0.257|TWO_SIDED|90.0|-14.61|2.75|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) are included in the model. For both panels, only the participants with RSV infection were included in the analysis. The mean VL-AUC in each group and the differences in mean VL-AUC between MK-4482 and placebo and the corresponding 2-sided 95% CI were computed based on the linear model.||2.75|-14.61|0.257
71087121|NCT05559905|141680280|SUPERIORITY||Difference in Least Squares Mean|-0.58||||0.453|TWO_SIDED|90.0|-1.88|0.71|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) are included in the model. For both panels, only the participants with RSV infection were included in the analysis. The mean PVL in each group and the differences in mean PVL between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||0.71|-1.88|0.453
71087122|NCT05559905|141680281|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.9121|TWO_SIDED|95.0|0.44|2.51|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||2.51|0.44|0.9121
71087123|NCT05559905|141680282|SUPERIORITY||Difference in Least Squares Mean|-1.83||||0.377|TWO_SIDED|90.0|-5.25|1.6|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) were included in the model. The TSS-AUC in each group and the differences in mean TSS-AUC between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||1.60|-5.25|0.377
71087124|NCT05559905|141680283|SUPERIORITY||Difference in Least Squares Mean|-0.13||||0.958|TWO_SIDED|90.0|-4.28|4.02|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) were included in the model. The TSS-AUC-CFB in each group and the differences in mean TSS-AUC-CFB between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||4.02|-4.28|0.958
71087125|NCT05559905|141680284|SUPERIORITY||Difference in Least Squares Mean|-0.62||||0.52|TWO_SIDED|90.0|-2.21|0.98|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) are included in the model. For both panels, only the participants with RSV infection were included in the analysis. The mean peak TSS in each group and the differences in mean peak TSS between MK-4482 and placebo and the corresponding 2- sided 95% CI was computed based on the linear model.||0.98|-2.21|0.520
71087126|NCT05559905|141680286|SUPERIORITY||Hazard Ratio (HR)|2.24||||0.0459|TWO_SIDED|95.0|0.99|5.07|||Log Rank|Two-sided p-value based on log-rank test.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||5.07|0.99|0.0459
71087127|NCT02756910|141680311|OTHER||percentile method|0.5|STANDARD_DEVIATION|1.96|<|0.05|TWO_SIDED|95.0|||||bootstrapping|||||||<0.05
71087128|NCT03829462|141680315|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.5334|TWO_SIDED|95.0|0.7|1.98||The threshold for statistical significance was p=0.05|Log Rank|||To show an increase of median overall survival from 7 to 15 months (30% to 57% rates, respectively), with a HR=0.47 and a power of 80% and alpha=5%, 55 events are required for the 78 patients to be randomized considering 15% additional patients for lost to follow-up.||1.98|0.7|0.5334
71087129|NCT03829462|141680315|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.8894|TWO_SIDED|95.0|0.59|1.82|||Chi-squared|||||1.82|0.59|0.8894
71087130|NCT03829462|141680316|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.1104|TWO_SIDED|95.0|0.4|1.11|||Log Rank|The threshold for statistical significance was p=0.05||||1.11|0.4|0.1104
71087131|NCT03829462|141680316|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.1165|TWO_SIDED|95.0|0.4|1.11|||Chi-squared|||||1.11|0.4|0.1165
71087132|NCT03829462|141680317|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.2425|TWO_SIDED|95.0|0.26|1.42||The threshold for statistical significance was p=0.05|Log Rank|||||1.42|0.26|0.2425
71087133|NCT03829462|141680317|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.2519|TWO_SIDED|95.0|0.26|1.42|||Chi-squared|||||1.42|0.26|0.2519
71087134|NCT03829462|141680318|SUPERIORITY||Percent difference|46.5||||0.001|TWO_SIDED||||||Fisher Exact|||||||0.001
71087135|NCT03829462|141680319|SUPERIORITY||Percent difference|7.4||||0.001|TWO_SIDED||||||Fisher Exact|||||||0.001
71087136|NCT02240667|141680326|OTHER|||||||0.8496|||||||stratified log-rank test|||Persistence in both treatment groups was compared by means of the stratified Log-rank test||||0.8496
71087137|NCT00791999|141680380|SUPERIORITY_OR_OTHER||||||<|0.025||95.0||||Wald p-values(vs. placebo) for the comparison of the treatment groups have been calculated using logistic regression with factors for treatment.|Regression, Logistic|||For ACR20 responder rate at Week 12, treatment comparisons versus placebo for the two CDP870 dose groups, the CDP870 200 mg group the CDP870 400 mg, were performed. The ACR20 responder rate in the CDP870 100 mg group was used for the secondary analysis.||||<0.025
71087138|NCT00791999|141680381|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Wald p-values(vs. placebo) for the comparison of the treatment groups have been calculated using logistic regression with factors for treatment.|Regression, Logistic|||||||<0.05
70945342|NCT01475461|141391159|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.481||0.5191|TWO_SIDED|80.0|-0.31|0.93||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.93|-0.31|0.5191
71124664|NCT04428151|141755303|SUPERIORITY||Hazard Ratio (HR)|1.48||||0.9963|TWO_SIDED|95.0|1.11|1.97||One-sided p-value based on log-rank test stratified by baseline PD-L1 TPS (\<50% versus ≥50%) and baseline ECOG performance status (0 versus 1). The reported p-value is nominal.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by baseline PD-L1 TPS (\<50% versus ≥50%) and baseline ECOG performance status (0 versus 1).|||1.97|1.11|0.9963
71124665|NCT04428151|141755304|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.4181|TWO_SIDED|95.0|0.74|1.28||One-sided p-value based on log-rank test stratified by baseline PD-L1 TPS (\<50% versus ≥50%) and baseline ECOG performance status (0 versus 1). The reported p-value is nominal.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by baseline PD-L1 TPS (\<50% versus ≥50%) and baseline ECOG performance status (0 versus 1).|||1.28|0.74|0.4181
71124666|NCT04428151|141755305|SUPERIORITY||Difference in Percentage|-6.5||||0.9266219|TWO_SIDED|95.0|-15.4|2.3|||Miettinen & Nurminen|One-sided p-value for testing H0: difference in % = 0 versus H1: difference in % \> 0. The reported p-value is nominal.|Based on Miettinen \& Nurminen method stratified by baseline PD-L1 TPS (\<50% versus ≥50%) and baseline ECOG performance status (0 versus 1).|||2.3|-15.4|0.9266219
71124667|NCT04068610|141755337|SUPERIORITY||Odds Ratio (OR)|1.8||||0.3173|TWO_SIDED|95.0|0.6|5.6|||Cochran-Mantel-Haenszel|P-value for comparison of treatment arms obtained from stratified Cochran-Mantel-Haenszel test stratified by the location of the primary tumor.||||5.6|0.6|0.3173
71124668|NCT02066415|141755378|SUPERIORITY|"A sequential testing procedure, specifically, the hierarchical gate-keeping procedures and Hochberg method, was used to maintain the 2-sided study-wise type I error at 0.05 between the 2 erenumab doses and the primary and secondary endpoints.~This comparison was tested at a 2-sided significance level of 0.04."|Difference in LS Means|-2.46|||<|0.001|TWO_SIDED|95.0|-3.52|-1.39|||Generalized linear mixed model|||The primary endpoint was analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.||-1.39|-3.52|<0.001
71124669|NCT02066415|141755378|SUPERIORITY|"A sequential testing procedure, specifically, the hierarchical gate-keeping procedures and Hochberg method, was used to maintain the 2-sided study-wise type I error at 0.05 between the 2 erenumab doses and the primary and secondary endpoints.~This comparison was tested at a 2-sided significance level of 0.01."|Difference in LS Means|-2.45|||<|0.001|TWO_SIDED|95.0|-3.51|-1.38|||Generalized linear mixed model|||The primary endpoint was analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.||-1.38|-3.51|<0.001
71124670|NCT02066415|141755379|SUPERIORITY|This comparison was tested at a 2-sided significance level of 0.04.|Odds Ratio (OR)|2.18|||<|0.001|TWO_SIDED|95.0|1.46|3.27|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel test after the missing data were imputed as non-response, stratified by stratification factors (region and medication overuse status).||3.27|1.46|<0.001
71124671|NCT02066415|141755379|SUPERIORITY|This comparison was tested at a 2-sided significance level of 0.01.|Odds Ratio (OR)|2.34|||<|0.001|TWO_SIDED|95.0|1.56|3.51|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel test after the missing data were imputed as non-response, stratified by stratification factors (region and medication overuse status).||3.51|1.56|<0.001
71124672|NCT02066415|141755380|SUPERIORITY|This comparison was tested at a 2-sided significance level of 0.04.|Difference in LS Means|-1.86|||<|0.001|TWO_SIDED|95.0|-2.6|-1.13|||Generalized linear mixed model|||Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.||-1.13|-2.60|<0.001
71124673|NCT02066415|141755380|SUPERIORITY|This comparison was tested at a 2-sided significance level of 0.01.|Difference in LS Means|-2.55|||<|0.001|TWO_SIDED|95.0|-3.28|-1.82|||Generalized linear mixed model|||Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.||-1.82|-3.28|<0.001
70945343|NCT01475461|141391159|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.479||0.5107|TWO_SIDED|80.0|-0.3|0.93||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.93|-0.30|0.5107
71124674|NCT02066415|141755381|SUPERIORITY|This comparison was tested at a 2-sided significance level of 0.04.|Difference in LS Means|-9.54||||0.28|TWO_SIDED|95.0|-26.98|7.9|||Generalized linear mixed model|||Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.||7.90|-26.98|0.28
71124675|NCT02066415|141755381|SUPERIORITY|This comparison was tested at a 2-sided significance level of 0.01.|Difference in LS Means|-19.31||||0.03|TWO_SIDED|95.0|-36.71|-1.92|||Generalized linear mixed model|||Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.||-1.92|-36.71|0.030
70945344|NCT01475461|141391159|SUPERIORITY_OR_OTHER||LS Mean Difference|0.79|STANDARD_ERROR_OF_MEAN|0.488||0.1054|TWO_SIDED|80.0|0.17|1.42||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.42|0.17|0.1054
70856989|NCT02446743|141200504|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|13.0|||||TWO_SIDED|95.0|8.8|18.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||18.3|8.8|
70856990|NCT02446743|141200504|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|20.0|||||TWO_SIDED|95.0|12.6|29.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||29.0|12.6|
70856991|NCT02446743|141200504|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|8.0|||||TWO_SIDED|95.0|2.7|14.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||14.7|2.7|
71124676|NCT03242252|141755391|SUPERIORITY||Difference in Least Squares (LS) Means|-0.1|STANDARD_ERROR_OF_MEAN|0.076||0.2095|TWO_SIDED|95.0|-0.245|0.054|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of Chronic Kidney Disease (CKD) stage (3A, 3B) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||0.054|-0.245|0.2095
71124677|NCT03242252|141755391|SUPERIORITY||Difference in LS Means|-0.24|STANDARD_ERROR_OF_MEAN|0.077||0.0021|TWO_SIDED|95.0|-0.386|-0.085|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||-0.085|-0.386|0.0021
71124678|NCT03242252|141755392|SUPERIORITY||Difference in LS Means|-0.587|STANDARD_ERROR_OF_MEAN|0.2397||0.0144|TWO_SIDED|95.0|-1.0564|-0.1169|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, and country as fixed effects, and baseline FPG as a covariate.||-0.1169|-1.0564|0.0144
71124679|NCT03242252|141755392|SUPERIORITY||Difference in LS Means|-0.478|STANDARD_ERROR_OF_MEAN|0.2368||0.0436|TWO_SIDED|95.0|-0.942|-0.0136|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, and country as fixed effects, and baseline FPG as a covariate.||-0.0136|-0.942|0.0436
71124680|NCT03242252|141755393|SUPERIORITY||Difference in LS Means|-2.28|STANDARD_ERROR_OF_MEAN|2.034||0.2627|TWO_SIDED|95.0|-6.265|1.709|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization stratum of CKD stage (3A, 3B) at screening, and country as fixed effects, and baseline SBP as a covariate.||1.709|-6.265|0.2627
71124681|NCT03242252|141755393|SUPERIORITY||Difference in LS Means|-2.53|STANDARD_ERROR_OF_MEAN|1.799||0.1602|TWO_SIDED|95.0|-6.052|1.0|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization stratum of CKD stage (3A, 3B) at screening, and country as fixed effects, and baseline SBP as a covariate.||1|-6.052|0.1602
70856992|NCT02446743|141200505|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|40.0|||||TWO_SIDED|95.0|33.9|46.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||46.3|33.9|
70856993|NCT02446743|141200505|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|49.0|||||TWO_SIDED|95.0|38.9|58.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||58.5|38.9|
70856994|NCT02446743|141200505|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|34.0|||||TWO_SIDED|95.0|26.6|42.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||42.2|26.6|
71124682|NCT03242252|141755394|SUPERIORITY||Difference in LS Means|-1.59|STANDARD_ERROR_OF_MEAN|1.301||0.2212|TWO_SIDED|95.0|-4.142|0.958|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and baseline SBP as a covariate.||0.958|-4.142|0.2212
71124683|NCT03242252|141755394|SUPERIORITY||Difference in LS Means|-1.63|STANDARD_ERROR_OF_MEAN|1.297||0.2089|TWO_SIDED|95.0|-4.171|0.912|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and baseline SBP as a covariate.||0.912|-4.171|0.2089
71124684|NCT03242252|141755395|SUPERIORITY||Difference in LS Means|-1.28|STANDARD_ERROR_OF_MEAN|0.326|<|0.0001|TWO_SIDED|95.0|-1.92|-0.644|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and baseline body weight as a covariate.||-0.644|-1.92|< 0.0001
71124685|NCT03242252|141755395|SUPERIORITY||Difference in LS Means|-0.82|STANDARD_ERROR_OF_MEAN|0.339||0.0155|TWO_SIDED|95.0|-1.487|-0.156|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and baseline body weight as a covariate.||-0.156|-1.487|0.0155
71124686|NCT03242252|141755396|SUPERIORITY||Percent Difference|-30.72||||0.0015|TWO_SIDED|95.0|-44.78|-13.07|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and and log-transformed baseline UACR as a covariate.||-13.07|-44.78|0.0015
71124687|NCT03242252|141755396|SUPERIORITY||Percent Difference|-36.18||||0.0003|TWO_SIDED|95.0|-49.91|-18.68|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and and log-transformed baseline UACR as a covariate.||-18.68|-49.91|0.0003
70856995|NCT02446743|141200505|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|27.0|||||TWO_SIDED|95.0|21.6|33.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||33.0|21.6|
70945345|NCT01475461|141391159|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.502||0.5341|TWO_SIDED|80.0|-0.33|0.96||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.96|-0.33|0.5341
71124688|NCT03242252|141755397|SUPERIORITY||Percentage Difference|1.5||||0.4328|TWO_SIDED|95.0|-2.23|5.21|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening and randomization strata of CKD stage (3A, 3B) at screening.||5.21|-2.23|0.4328
71124689|NCT03242252|141755397|SUPERIORITY||Percentage Difference|1.5||||0.4328|TWO_SIDED|95.0|-2.2|5.17|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening and randomization strata of CKD stage (3A, 3B) at screening.||5.17|-2.2|0.4328
71124690|NCT03242252|141755398|SUPERIORITY||Percentage Difference|6.0||||0.0614|TWO_SIDED|95.0|-0.23|12.21|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening and randomization strata of CKD stage (3A, 3B) at screening.||12.21|-0.23|0.0614
71124691|NCT03242252|141755398|SUPERIORITY||Percentage Difference|7.4||||0.023|TWO_SIDED|95.0|1.08|13.65|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening and randomization strata of CKD stage (3A, 3B) at screening.||13.65|1.08|0.023
71124692|NCT01116427|141755407|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED|||||Analysis was stratified on the presence or absence of subclinical activity as demonstrated by a Gd-enhanced lesion on one MRI in the past year prior to enrollment.|Wilcoxon (Mann-Whitney)|||||||0.87
71124693|NCT01116427|141755408|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED|||||Wilcoxon rank sum test in which the total number of new lesions were converted to ranks and then compared between groups|Wilcoxon (Mann-Whitney)|||||||0.36
71124694|NCT01116427|141755409|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED|||||Rank sum test in which the lesion volume change values per participant were converted to ranks and compared between the treatment groups|Wilcoxon (Mann-Whitney)|||||||0.93
71124695|NCT01116427|141755410|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED|||||Wilcoxon rank sum test in which percent brain volume change values per participant were converted to ranks and the ranks were compared between groups|Wilcoxon (Mann-Whitney)|||||||0.68
71124696|NCT01116427|141755411|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED|||||Wilcoxon rank sum test in which mean numbers of new lesions per participant were converted to ranks and compared between groups|Wilcoxon (Mann-Whitney)|||||||0.21
71124697|NCT01116427|141755412|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||Fisher Exact|||||||0.65
71124698|NCT01116427|141755414|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED|||||Wilcoxon rank sum test in which the change from baseline scores per subject were converted to ranks and compared between treatment groups|Wilcoxon (Mann-Whitney)|||||||0.13
71124699|NCT01116427|141755415|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED|||||Analysis was stratified on the presence or absence of subclinical activity as demonstrated by a Gd-enhanced lesion on one MRI in the past year prior to enrollment.|Wilcoxon (Mann-Whitney)|||||||0.06
71124700|NCT01116427|141755416|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||Rank sum test in which the lesion volume change values per participant were converted to ranks and compared between the treatment groups|Wilcoxon (Mann-Whitney)|||||||0.07
70856996|NCT02446743|141200505|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|23.0|||||TWO_SIDED|95.0|15.5|32.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||32.0|15.5|
70856997|NCT02446743|141200505|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|30.0|||||TWO_SIDED|95.0|22.9|38.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||38.1|22.9|
71124701|NCT01116427|141755417|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED|||||Wilcoxon rank sum test in which the percent brain volume change values per participant were converted to ranks and compared between treatment groups|Wilcoxon (Mann-Whitney)|||||||0.88
71124702|NCT01116427|141755418|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Fisher Exact|||||||0.29
71124703|NCT01116427|141755420|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED|||||Wilcoxon rank sum test in which the change from baseline scores per participant were converted to ranks and compared between treatment groups|Wilcoxon (Mann-Whitney)|||||||0.67
71124704|NCT03973905|141755426|OTHER||Vaccine Effectiveness|65.26|||||TWO_SIDED|95.0|-64.93|92.68|||||Vaccine Effectiveness (VE) was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix during third trimester of pregnancy (at least 14 days before delivery) at preventing pertussis in infants \<2 months||92.68|-64.93|
70856998|NCT02446743|141200505|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|43.0|||||TWO_SIDED|95.0|35.1|50.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||50.6|35.1|
70945346|NCT01475461|141391159|SUPERIORITY_OR_OTHER||LS Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.487||0.2782|TWO_SIDED|80.0|-0.1|1.15||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.15|-0.10|0.2782
71124705|NCT03973905|141755427|OTHER||Vaccine Effectiveness|42.01|||||TWO_SIDED|95.0|-1071.8|97.13|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix before pregnancy at preventing pertussis in infants \<2 months||97.13|-1071.80|
71124706|NCT03973905|141755427|OTHER||Vaccine Effectiveness|62.17|||||TWO_SIDED|95.0|-439.75|97.35|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix during first or second trimester of pregnancy at preventing pertussis in infants \<2 months||97.35|-439.75|
71124707|NCT03973905|141755427|OTHER||Vaccine Effectiveness|-12.89|||||TWO_SIDED|95.0|-166.37|52.16|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix after pregnancy at preventing pertussis in infants \<2 months||52.16|-166.37|
70945347|NCT01475461|141391159|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.492||0.5331|TWO_SIDED|80.0|-0.32|0.94||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.94|-0.32|0.5331
70945348|NCT01475461|141391159|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.489||0.907|TWO_SIDED|80.0|-0.57|0.68||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.68|-0.57|0.9070
70945349|NCT01475461|141391159|SUPERIORITY_OR_OTHER||LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.512||0.1757|TWO_SIDED|80.0|0.04|1.35||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.35|0.04|0.1757
71087139|NCT01077323|141680382|SUPERIORITY_OR_OTHER||Adjusted Rate Ratio (ARR)|0.87|||||TWO_SIDED|95.0|0.59|1.28|||||"ARR equals adjusted incidence rate of acute pancreatitis in exenatide cohort divided by adjusted incidence of acute pancreatitis in OAD cohort.~Adjusted incidence rates were calculated using a Poisson regression model adjusted for propensity score."|||1.28|0.59|
71087140|NCT01077323|141680383|SUPERIORITY_OR_OTHER||Adjusted Rate Ratio (ARR)|1.1|||||TWO_SIDED|95.0|0.8|1.5|||||ARR equals adjusted incidence rate of acute pancreatitis in exenatide cohort divided by adjusted incidence of acute pancreatitis in OAD cohort.Rate ratios adjusted for propensity score of exenatide initiation using Cox Proportional Hazards Regression|||1.5|0.8|
71087141|NCT01077323|141680384|SUPERIORITY_OR_OTHER||Adjusted Rate Ratio (ARR)|0.87|||||TWO_SIDED|95.0|0.36|2.09|||||"ARR equals adjusted incidence rate of acute pancreatitis in exenatide cohort divided by adjusted incidence of acute pancreatitis in OAD cohort.~Adjusted incidence rates were calculated using a Poisson regression model adjusted for propensity score."|||2.09|0.36|
71087142|NCT01077323|141680385|SUPERIORITY_OR_OTHER||Adjusted Rate Ratio (ARR)|1.39|||||TWO_SIDED|95.0|0.86|2.25|||||"ARR equals adjusted incidence rate of acute pancreatitis in exenatide cohort divided by adjusted incidence of acute pancreatitis in OAD cohort.~Adjusted incidence rates were calculated using a Poisson regression model adjusted for propensity score."|||2.25|0.86|
71087143|NCT00427908|141680399|NON_INFERIORITY|Criterion indicative of non-inferiority: lower limit of the standardized asymptotic 95% confidence interval (CI) for the group difference (Nimenrix minus Mencevax) in the percentage of subjects with bactericidal vaccine response to be greater than or equal to -15% for rSBA-MenA.|Difference in percentage|6.44|||||TWO_SIDED|95.0|1.15|16.04||||||To evaluate the non-inferiority of Nimenrix™ conjugate vaccine compared to Mencevax™ plain polysaccharide vaccine in terms of the vaccine response (VRR) to MenA. Response to a vaccine antigen component was defined as: For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32. For initially seropositive subject, at least 4-fold increase in rSBA-MenA titer from pre to post vaccination.||16.04|1.15|
71087144|NCT00427908|141680399|NON_INFERIORITY|Criterion indicative of non-inferiority: lower limit of the standardized asymptotic 95% confidence interval (CI) for the group difference (Nimenrix minus Mencevax) in the percentage of subjects with bactericidal vaccine response is greater than or equal to -15% for rSBA-MenC.|Difference in percentage|13.18|||||TWO_SIDED|95.0|4.79|24.32||||||To evaluate the non-inferiority of Nimenrix™ conjugate vaccine compared to Mencevax™ plain polysaccharide vaccine in terms of the vaccine response (VRR) to MenC. Response to a vaccine antigen component was defined as: For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32. For initially seropositive subject, at least 4-fold increase in rSBA-MenC titer from pre to post vaccination.||24.32|4.79|
71087145|NCT00427908|141680399|NON_INFERIORITY|Criterion indicative of non-inferiority: lower limit of the standardized asymptotic 95% confidence interval (CI) for the group difference (Nimenrix minus Mencevax) in the percentage of subjects with bactericidal vaccine response is greater than or equal to -15% for rSBA-MenW-135.|Difference in percentage|4.41|||||TWO_SIDED|95.0|1.51|12.21||||||To evaluate the non-inferiority of Nimenrix™ conjugate vaccine compared to Mencevax™ plain polysaccharide vaccine in terms of the vaccine response (VRR) to MenW-135. Response to a vaccine antigen component was defined as: For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32. For initially seropositive subject, at least 4-fold increase in rSBA-MenW-135 titer from pre to post vaccination.||12.21|1.51|
71124708|NCT03973905|141755428|OTHER||Vaccine Effectiveness|64.79|||||TWO_SIDED|95.0|-57.51|92.13|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix at any time during pregnancy at preventing pertussis in infants \<2 months||92.13|-57.51|
71124709|NCT03973905|141755429|OTHER||Vaccine Effectiveness|17.65|||||TWO_SIDED|95.0|-12529.0|99.46|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix before pregnancy at preventing pertussis in infants \<2 months||99.46|-12529.0|
71124710|NCT03973905|141755429|OTHER||Vaccine Effectiveness|85.01|||||TWO_SIDED|95.0|-13.91|98.03|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix during third trimester of pregnancy at preventing pertussis in infants \<2 months||98.03|-13.91|
71124711|NCT03973905|141755429|OTHER||Vaccine Effectiveness|37.64|||||TWO_SIDED|95.0|-87.4|79.25|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix after pregnancy at preventing pertussis in infants \<2 months||79.25|-87.40|
71124712|NCT02648217|141755430|SUPERIORITY_OR_OTHER||Treatment Contrast|0.02||||0.8426|TWO_SIDED|95.0|-0.2|0.24|||Mixed model for repeated measurements|||The endpoint was analysed using mixed model for repeated measurements (MMRM) with an unstructured covariance matrix. The model included treatment, sex, region, previous OAD treatment, pre-Ramadan trial exposure and visit as factors and age and baseline value of the endpoint as covariates. Interactions between visit and all factors and covariates are included in the model.||0.24|-0.20|0.8426
71124713|NCT02411929|141755545|SUPERIORITY_OR_OTHER||Test (oral)/Reference (IV) of means|104.73|||||TWO_SIDED|90.0|101.64|107.91|||||Natural log transformed AUCinf(dn) and AUClast(dn) from Period 1 were analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences were exponentiated.|Ratio - Test (oral) / Reference (IV) of means||107.91|101.64|
71124714|NCT02411929|141755555|SUPERIORITY_OR_OTHER||Ratio|110.71|||||||||||||The ratio (Test/Reference) of the geometric means of dose normalized natural log transformed Total 14\^C in Urine will be estimated. Total 14\^C\_Urine\_IV is the Reference formulation and Total 14C\_Urine\_Oral is the Test formulation (expressed as a %).|Ratio - Test (Oral) / Reference (IV) (%)||||
71124715|NCT02715726|141755558|SUPERIORITY||LS mean difference|-35.6|||<|0.0001|TWO_SIDED|95.0|-40.6|-30.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Alirocumab group was compared to ezetimibe group using an appropriate contrast statement.||-30.7|-40.6|<0.0001
71124716|NCT02715726|141755559|SUPERIORITY||LS mean difference|-37.3|||<|0.0001|TWO_SIDED|95.0|-42.1|-32.6||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|A hierarchical testing method was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-32.6|-42.1|<0.0001
71124717|NCT02715726|141755560|SUPERIORITY||LS mean difference|-34.9|||<|0.0001|TWO_SIDED|95.0|-39.5|-30.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-30.2|-39.5|<0.0001
71124718|NCT02715726|141755561|SUPERIORITY||LS mean difference|-35.4|||<|0.0001|TWO_SIDED|95.0|-40.0|-30.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-30.7|-40.0|<0.0001
71124719|NCT02715726|141755562|SUPERIORITY|Threshold for significance at 0.05 level.|LS mean difference|-27.4|||<|0.0001|TWO_SIDED|95.0|-30.8|-23.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-23.9|-30.8|<0.0001
70856999|NCT02446743|141200505|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|51.0|||||TWO_SIDED|95.0|39.3|60.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||60.9|39.3|
71087146|NCT00427908|141680399|NON_INFERIORITY|Criterion indicative of non-inferiority: lower limit of the standardized asymptotic 95% confidence interval (CI) for the group difference (Nimenrux minus Mencevax) in the percentage of subjects with bactericidal vaccine response is greater than or equal to -15% for rSBA-MenY.|Difference in percentage|16.23|||||TWO_SIDED|95.0|8.99|26.78||||||To evaluate the non-inferiority of Nimenrix™ conjugate vaccine compared to Mencevax™ plain polysaccharide vaccine in terms of the vaccine response (VRR) to MenY. Response to a vaccine antigen component was defined as: For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32. For initially seropositive subject, at least 4-fold increase in rSBA-MenY titer from pre to post vaccination.||26.78|8.99|
71087147|NCT00427908|141680402|NON_INFERIORITY|Criterion indicative of non-inferiority (serogroup C only): one month after vaccination, the lower limit of the 2-sided standardized asymptotic 95% CI for the group difference (Nimenrix Group minus Meningitec Group) in the percentage of subjects with rSBA titer ≥ 1:8 is greater than or equal to the predefined clinical limit of -15%.|Difference in vaccine response rate|1.47|||||TWO_SIDED|95.0|-0.27|7.89||||||To evaluate the non-inferiority of the vaccine response induced by Nimenrix™ conjugate vaccine when compared to the licensed Meningitec™ vaccine for MenC as measured by rSBA.||7.89|-0.27|
71124720|NCT02715726|141755563|SUPERIORITY||LS mean difference|-27.8|||<|0.0001|TWO_SIDED|95.0|-31.2|-24.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-24.4|-31.2|<0.0001
71124721|NCT02715726|141755564|SUPERIORITY||LS mean difference|-27.7|||<|0.0001|TWO_SIDED|95.0|-31.8|-23.6||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-23.6|-31.8|<0.0001
71124722|NCT02715726|141755565|SUPERIORITY||LS mean difference|-28.7|||<|0.0001|TWO_SIDED|95.0|-32.6|-24.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-24.7|-32.6|<0.0001
71124723|NCT02715726|141755566|SUPERIORITY||LS mean difference|-20.2|||<|0.0001|TWO_SIDED|95.0|-23.1|-17.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-17.2|-23.1|<0.0001
71124724|NCT02715726|141755567|SUPERIORITY||LS mean difference|-26.5|||<|0.0001|TWO_SIDED|95.0|-29.8|-23.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-23.2|-29.8|<0.0001
71124725|NCT02715726|141755568|SUPERIORITY||LS mean difference|-26.7|||<|0.0001|TWO_SIDED|95.0|-30.5|-22.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-22.8|-30.5|<0.0001
71124726|NCT02715726|141755569|SUPERIORITY||LS mean difference|-19.3|||<|0.0001|TWO_SIDED|95.0|-22.1|-16.5||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-16.5|-22.1|<0.0001
71124727|NCT02715726|141755570|SUPERIORITY||Odds Ratio (OR)|11.2|||<|0.0001|TWO_SIDED|95.0|7.1|17.7||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 75 mg Q2W/up to 150 mg Q2W vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||17.7|7.1|<0.0001
71124728|NCT02715726|141755571|SUPERIORITY||Odds Ratio (OR)|13.6|||<|0.0001|TWO_SIDED|95.0|8.3|22.3||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 75 mg Q2W/up to 150 mg Q2W vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||22.3|8.3|<0.0001
71124729|NCT02715726|141755572|SUPERIORITY||Adjusted Mean Difference|-34.273|||<|0.0001|TWO_SIDED|95.0|-39.262|-29.285||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-29.285|-39.262|<0.0001
71124730|NCT02715726|141755573|SUPERIORITY||LS mean difference|1.9||||0.228|TWO_SIDED|95.0|-1.2|4.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||4.9|-1.2|0.2280
71124731|NCT03995355|141755623|NON_INFERIORITY|Subjective overall comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least square mean difference|11.3|STANDARD_ERROR_OF_MEAN|4.44|||TWO_SIDED|95.0|2.6|20.1|||Linear Mixed Model Analysis||Least square mean difference was calculated as Test minus Control|||20.1|2.6|
70857000|NCT02446743|141200505|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|41.0|||||TWO_SIDED|95.0|29.9|50.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||50.2|29.9|
70945350|NCT01475461|141391159|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.527||0.4083|TWO_SIDED|80.0|-0.24|1.11||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.11|-0.24|0.4083
71087148|NCT02984982|141680480|SUPERIORITY||LS mean difference|-1.64|STANDARD_ERROR_OF_MEAN|1.36||0.2279|TWO_SIDED|95.0|-4.32|1.04||Threshold for significance at 0.05 level.|ANCOVA||Standard of Care vs Alirocumab|Analysis was performed using ANCOVA model which included fixed categorical effects of treatment arm and randomization strata, as well as the continuous fixed covariate of baseline normalized TAV.||1.04|-4.32|0.2279
71087149|NCT02616783|141680510|SUPERIORITY||Difference in Percentages|2.427|||<|0.001|TWO_SIDED|95.0|1.337|3.517|||ANOVA|P-value was calculated using the ANOVA model with baseline spine BMD score, sex, and treatment as fixed effects.|The 95% confidence intervals (CI) were calculated using the ANOVA model with baseline spine BMD score, sex, and treatment as fixed effects.|||3.517|1.337|<0.001
71087150|NCT02616783|141680511|SUPERIORITY||Difference in percentages|2.036|||<|0.001|TWO_SIDED|95.0|1.168|2.904|||ANOVA|P-value was calculated using the ANOVA model with baseline hip BMD score, sex, and treatment as fixed effects.|The 95% CIs were calculated using the ANOVA model with baseline hip BMD score, sex, and treatment as fixed effects.|||2.904|1.168|<0.001
70945351|NCT01475461|141391159|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|0.511||0.315|TWO_SIDED|80.0|-0.14|1.17||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.17|-0.14|0.3150
70945352|NCT01475461|141391159|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.516||0.6631|TWO_SIDED|80.0|-0.44|0.89||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.89|-0.44|0.6631
70945353|NCT01475461|141391159|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.512||0.8694|TWO_SIDED|80.0|-0.74|0.57||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.57|-0.74|0.8694
70945354|NCT01475461|141391159|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.545||0.2031|TWO_SIDED|80.0|0.0|1.4||P-value was 2-sided.|t-test, 2 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.40|0.00|0.2031
70945355|NCT01475461|141391159|SUPERIORITY_OR_OTHER||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.563||0.7137|TWO_SIDED|80.0|-0.52|0.93||P-value was 2-sided.|t-test, 2 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.93|-0.52|0.7137
70945356|NCT01475461|141391159|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.545||0.681|TWO_SIDED|80.0|-0.48|0.92||P-value was 2-sided.|t-test, 2 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.92|-0.48|0.6810
71087151|NCT02616783|141680512|SUPERIORITY||Difference in percentages|1.749|||<|0.001|TWO_SIDED|95.0|0.726|2.771|||ANOVA|P-value was calculated using the ANOVA model with baseline spine BMD score, sex, and treatment as fixed effects.|The 95% CIs were calculated using the ANOVA model with baseline spine BMD score, sex, and treatment as fixed effects.|||2.771|0.726|<0.001
71087152|NCT02616783|141680513|SUPERIORITY||Difference in percentages|1.351|||<|0.001|TWO_SIDED|95.0|0.602|2.099|||ANOVA|P-value was calculated using the ANOVA model with baseline hip BMD score, sex, and treatment as fixed effects.|The 95% CIs were calculated using the ANOVA model with baseline hip BMD score, sex, and treatment as fixed effects.|||2.099|0.602|<0.001
71087153|NCT02616783|141680514|SUPERIORITY||Difference in percentages|-5.5||||0.18|TWO_SIDED|95.0|-11.8|1.6||P-values for the superiority test comparing the percentages of participants with HIV-1 RNA \< 50 copies/mL were from the Fisher exact test.|Fisher Exact||Differences in percentages and 95% CI were generated based on exact method.|||1.6|-11.8|0.18
71087154|NCT02616783|141680515|SUPERIORITY||Difference in percentages|-1.0||||1|TWO_SIDED|95.0|-8.5|9.3|||Fisher Exact|P-values for the superiority test comparing the percentages of participants with HIV-1 RNA \< 50 copies/mL were from the Fisher exact test.|Differences in percentages and 95% CI were generated based on exact method.|||9.3|-8.5|1.00
71087155|NCT02616783|141680516|SUPERIORITY||Difference in LSM|52.0||||0.053|TWO_SIDED|95.0|-1.0|106.0|||ANOVA|The p-value, difference in least square means (LSM), and its 95% CI were from ANOVA model with treatment as a fixed effect.||||106|-1|0.053
71087156|NCT02616783|141680517|SUPERIORITY||Difference in LSM|57.0||||0.051|TWO_SIDED|95.0|0.0|115.0|||ANOVA|The p-value, difference in LSM, and its 95% CI were from ANOVA model with treatment as a fixed effect.||||115|0|0.051
71087157|NCT04010461|141680554|SUPERIORITY||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.097|=|0.11|TWO_SIDED|95.0|-0.037|0.355|||t-test, 2 sided|df = 35 Note: 1 subject was excluded from analysis as extraction of FPN eigenvalues failed due to technical deficiencies with image data||Analysis used standard, open-source methods for pre-processing . First-level analysis used the general framework of the modified General Linear Model, implemented in SPM12 with temporal convolution. For the n-back activation task, the first-level design matrix included regressors for 2-back and 1-back conditions, as well as 24 movement parameters. Statistical testing was done to establish whether more or less BOLD (neural activity) change occurred between two conditions.||0.355|-0.037|=0.11
71087158|NCT04010461|141680554|SUPERIORITY||Mean Difference (Final Values)|-0.009|STANDARD_ERROR_OF_MEAN|0.116||0.94|TWO_SIDED|95.0|-0.245|0.227|||t-test, 2 sided|df = 35 Note: 1 subject excluded from analysis as FPN extraction of eigenvalues failed due to technical issues with image data||Analysis used standard, open-source routes for slice timing correction, field map correction, realignment, smoothing (6 mm Gaussian kernel) and spatial normalization (MNI-152). First-level analysis used the general framework of the modified General Linear Model, implemented in SPM12 with temporal convolution. For the n-back activation task, the first-level design matrix included regressors for 2-back and 1-back conditions, as well as 24 movement parameters.||0.227|-0.245|0.94
71087159|NCT04010461|141680555|OTHER|Group-level analyses were performed using a General Linear Model (GLM). For each individual voxel, a separate GLM was estimated, with first-level connectivity measures at this voxel as dependent variables, and groups or other subject-level identifiers as independent variables. Voxel-level hypotheses were evaluated using multivariate parametric statistics with random effects across subjects and sample covariance estimation across multiple measurements.|random field theory|0.0||||1|TWO_SIDED|||||Inferences were performed at the level of individual clusters (groups of contiguous voxels). Cluster-level inferences were based on parametric statistics from Gaussian Random Field theory.|random field theory|Results were thresholded using a combination of a cluster-forming p \< 0.001 voxel-level threshold, and cluster-size threshold of 25 voxels|Number indicates the number of clusters above the threshold of significance for the contrast between two arms (passive vs active)|The contrast reflects the difference in connectivity between the conditions/sessions, at the level of each subject, then spatially averaged across all subjects. Functional connectivity strength for the dlPFC seed was represented by Fisher-transformed bivariate correlation coefficients from a weighted general linear model (weighted-GLM), defined separately for each pair of seed and target areas, modeling the association between their BOLD signal time series.||||1
71087160|NCT04010461|141680555|OTHER|The applied test with random field theory uses a metric of spatial dispersion, testing against the null hypothesis that spatial clusters of difference across the analyzed region are no different from chance clustering.|random field theory|0.0||||1|TWO_SIDED||||||random field theory||Number indicates the number of clusters above the threshold of significance for the contrast between two arms (passive vs control)|Results were thresholded using a combination of a cluster-forming p \< 0.001 voxel-level threshold, and a corrected false discovery rate (FDR) p \< 0.05 cluster-size threshold.||||1
71087161|NCT04010461|141680556|SUPERIORITY||F-ratio|0.1||||0.91|TWO_SIDED||||||ANOVA|||||||0.91
71087162|NCT04010461|141680557|SUPERIORITY|||||||0.55|||||||ANOVA|||||||0.55
71087163|NCT04010461|141680557|SUPERIORITY|||||||0.65|||||||ANOVA|||||||.65
71087164|NCT04010461|141680558|OTHER||cluster size|42.0||||0.54|TWO_SIDED|||||P-value above represents the lowest (most significant) value of the largest cluster, for the contrast of Passive \> Active, testing whether the cluster size is greater than chance.|random field theory||The estimated parameter is the size, in voxels, of the largest cluster. The applied test with random field theory tests whether the size of cluster difference across are no different from chance clustering.|Statistical thresholding using a random field model adjusted for multiple comparisons, with initial voxel magnitude/height threshold set at p \< 0.001 and peak and cluster-corrected significance levels obtained (false discovery rate \[FDR\]corrected), across the entire brain.||||0.54
71087165|NCT04010461|141680558|SUPERIORITY||cluster size|16.0||||0.93|TWO_SIDED|||||P-value above represents the lowest (most significant) value of the largest cluster, for the contrast of Passive \> Control, testing whether the size of this cluster is greater than one would expect by chance alone.|random field theory||The estimated parameter is the size, in voxels, of the largest cluster. The applied test with random field theory tests whether the size of cluster difference across are no different from chance clustering.|Statistical thresholding using a random field model adjusted for multiple comparisons, with initial voxel magnitude/height threshold set at p \< 0.001 and peak and cluster-corrected significance levels obtained (false discovery rate \[FDR\]corrected), across the entire brain..||||0.93
71087166|NCT04010461|141680559|SUPERIORITY||F-ratio|0.22||||0.8|TWO_SIDED||||||ANOVA|||Repeated measures ANOVA to test for differences in cerebral blood flow (perfusion) in the frontoparietal network||||0.8
71087167|NCT04010461|141680560|SUPERIORITY||F-ratio|3.96||||0.06|TWO_SIDED||||||ANOVA|||||||0.06
71087168|NCT04010461|141680560|SUPERIORITY||F-ratio|0.17||||0.68|TWO_SIDED||||||ANOVA|||||||0.68
71087169|NCT04010461|141680561|SUPERIORITY|Repeated measures ANOVA for 1- and 2-back conditions|F-ratio|0.72||||0.41|TWO_SIDED||||||ANOVA|||||||0.41
71087170|NCT04010461|141680561|SUPERIORITY|||||||0.5|||||||ANOVA|||||||0.50
71124732|NCT03995355|141755624|NON_INFERIORITY|Subjective overall comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least square mean difference|2.6|STANDARD_ERROR_OF_MEAN|3.97|||TWO_SIDED|95.0|-5.3|10.4|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Least square mean difference was calculated as Test minus Control|||10.4|-5.3|
71124733|NCT03995355|141755625|OTHER||Odds Ratio (OR)|0.967|||||TWO_SIDED|95.0|0.528|1.77|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control. No difference was concluded if 1 fall within the 95% confidence interval for the odds ratio.|||1.770|0.528|
70945357|NCT01475461|141391159|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.55||0.6921|TWO_SIDED|80.0|-0.92|0.49||P-value was 2-sided.|t-test, 2 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.49|-0.92|0.6921
70945358|NCT01475461|141391159|SUPERIORITY_OR_OTHER||LS Mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.545||0.3702|TWO_SIDED|80.0|-1.19|0.21||P-value was 2-sided.|t-test, 2 sided|||Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.21|-1.19|0.3702
70945359|NCT03214250|141391189|SUPERIORITY|One-sided|probability|0.577||||0.006|ONE_SIDED|95.0|0.417|||one-sided p-value|z-test|One-sided, one-sample z-test of the Kaplan-Meier estimate of the 1-year OS rate (and its standard error) against the historical rate of 35%||Each treatment arm was analyzed independently and compared to a historical 1-year OS reference rate of 35%.|||0.417|0.006
71087171|NCT02027025|141680596|SUPERIORITY||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.64||0.4532|TWO_SIDED|95.0|-1.73|0.78|||ANCOVA|||||0.78|-1.73|0.4532
70945360|NCT03214250|141391189|SUPERIORITY|One-sided|probability|0.481||||0.062|ONE_SIDED|95.0|0.337|||one-sided p-value|z-test|One-sided, one-sample z-test of the Kaplan-Meier estimate of the 1-year OS rate (and its standard error) against the historical rate of 35%||Each treatment arm was analyzed independently and compared to a historical 1-year OS reference rate of 35%.|||0.337|0.062
71087172|NCT02027025|141680596|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.65||0.4704|TWO_SIDED|95.0|-1.76|0.82|||ANCOVA|||||0.82|-1.76|0.4704
71087173|NCT02027025|141680597|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.18||0.3013|TWO_SIDED|95.0|-0.56|0.17|||ANCOVA|||||0.17|-0.56|0.3013
70857001|NCT02446743|141200505|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|19.0|||||TWO_SIDED|95.0|12.9|24.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||24.6|12.9|
70945361|NCT03214250|141391189|SUPERIORITY|One-sided|probability|0.413||||0.233|ONE_SIDED|95.0|0.27|||one-sided p-value|z-test|One-sided, one-sample z-test of the Kaplan-Meier estimate of the 1-year OS rate (and its standard error) against the historical rate of 35%||Each treatment arm was analyzed independently and compared to a historical 1-year OS reference rate of 35%.|||0.270|0.233
70945362|NCT01376050|141391197|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Fisher Exact|||||||>0.05
70945363|NCT01376050|141391198|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>0.05
71087174|NCT02027025|141680597|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.2994|TWO_SIDED|95.0|-0.58|0.18|||ANCOVA|||||0.18|-0.58|0.2994
71124734|NCT03995355|141755625|OTHER||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.61|2.203|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control. No difference was concluded if 1 fall within the 95% confidence interval for the odds ratio.|30-Day follow-up||2.203|0.610|
71124735|NCT03995355|141755626|OTHER||Odds Ratio (OR)|1.601|||||TWO_SIDED|95.0|0.178|19.616|||Fisher Exact||Odds ratio was calculated as Test over Control|||19.616|0.178|
71124736|NCT03995355|141755627|OTHER||Mean Difference (Net)|8.0|STANDARD_ERROR_OF_MEAN|3.73|||TWO_SIDED|95.0|0.7|15.4|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Least square mean difference was calculated as Test minus Control|||15.4|0.7|
71124737|NCT03995355|141755628|OTHER||Mean Difference (Net)|9.3|STANDARD_ERROR_OF_MEAN|3.86|||TWO_SIDED|95.0|1.7|17.0|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Least square mean difference was calculated as Test minus Control|||17.0|1.7|
71087175|NCT02027025|141680598|SUPERIORITY|||||||0.3815|||||||Chi-squared|||||||0.3815
71087176|NCT02027025|141680598|SUPERIORITY|||||||0.7491|||||||Chi-squared|||||||0.7491
71087177|NCT02027025|141680599|SUPERIORITY|||||||0.8991|||||||Chi-squared|||||||0.8991
71087178|NCT02027025|141680599|SUPERIORITY|||||||0.8829|||||||Chi-squared|||||||0.8829
71087179|NCT01939314|141680600|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.5|||||TWO_SIDED|95.0|-13.0|27.1||||||||27.1|-13.0|
71087180|NCT01939314|141680602|SUPERIORITY_OR_OTHER||Risk Difference (RD)|24.7|||||TWO_SIDED|95.0|2.6|43.6||||||||43.6|2.6|
71124738|NCT03945019|141755629|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by Previous biologic agent and/or JAK inhibitors exposure, Use of oral corticosteroids treatment at Week 0, Clinical remission at Week 10.||||||<0.0001
71124739|NCT03945019|141755630|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by Previous biologic agent and/or JAK inhibitors exposure, Use of oral corticosteroids treatment at Week 0, Clinical remission at Week 10.||||||<0.0001
71124740|NCT01325714|141755656|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were based on the ability to detect a small-to-moderate difference (Cohen's h = .4) between treatment groups in rate of aggression onset over a 1-year period, assuming 80% power and T1 error rate of 5%. This differential rate in aggression onset is comparable to a 37% rate of aggression onset over a 1 year period for the control group versus 19% for the treatment group. Given this, our goal was to include 220 total participants (after 10% attrition: N = 198).|Hazard Ratio (HR)|0.71||||0.13|TWO_SIDED|95.0|0.45|1.11||This is the p value from the discrete-time Cox regression time-to-event analyses|Regression, Cox|DF = 1|The enhanced usual care arm is the comparison group.|"Univariate time-to-event analyses, using discrete-time Cox regression models to evaluate differences between PAVeD and EU-PC in the primary outcome of incidence of aggression over time.~We expected that patients with dementia among dyads randomized to PAVeD arm would be less likely to develop aggression compared to those randomized to the enhanced usual care arm."||1.11|0.45|0.13
70857002|NCT02446743|141200505|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|28.0|||||TWO_SIDED|95.0|17.9|37.8|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||37.8|17.9|
70857003|NCT02446743|141200505|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|13.0|||||TWO_SIDED|95.0|6.4|20.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||20.1|6.4|
70857004|NCT02446743|141200506|OTHER|"Vaccine comparison Pre-booster or pre-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|2.6|||||TWO_SIDED|95.0|2.11|3.2|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||3.20|2.11|
70857005|NCT02446743|141200506|OTHER|"Vaccine comparison Post-booster or post-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|11.0|||||TWO_SIDED|95.0|8.85|15.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||15|8.85|
70857006|NCT02446743|141200506|OTHER|Vaccine comparison-Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|2.18|||||TWO_SIDED|95.0|1.7|2.79|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||2.79|1.70|
71124741|NCT01325714|141755656|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were based on the ability to detect a small-to-moderate difference (Cohen's h = .4) between treatment groups in rate of aggression onset over a 1-year period, assuming 80% power and T1 error rate of 5%. This differential rate in aggression onset is comparable to a 37% rate of aggression onset over a 1 year period for the control group versus 19% for the treatment group. Given this, our goal was to include 220 total participants (after 10% attrition: N = 198).|Hazard Ratio (HR)|0.77||||0.39|TWO_SIDED|95.0|0.43|1.39||From discrete time-cox regression time-to-event analysis.|Regression, Cox|df = 1|The enhanced usual care arm is the reference group.|Comparison of incidence of non-verbal aggression between treatment groups.||1.39|0.43|0.39
71124742|NCT01325714|141755656|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were based on the ability to detect a small-to-moderate difference (Cohen's h = .4) between treatment groups in rate of aggression onset (the primary outcome) over a 1-year period, assuming 80% power and type I error rate of 5%. This differential rate in aggression onset is comparable to a 37% rate of aggression onset over a 1 year period for the control group (anticipated based on estimated rates from prior work) versus 19% for the treatment group|Hazard Ratio (HR)|0.84||||0.84|TWO_SIDED|95.0|0.51|1.37||From discrete-time Cox regression time-to-event analyses|Regression, Cox|df = 1|The usual care arm is the reference group.|Examination of group differences in incidence of verbal aggression. We expected those in paved to have lower incidence of verbal aggression relative to those in enhanced usual care.||1.37|0.51|0.84
71124743|NCT01325714|141755657|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|0.86||||0.46|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 455) = 0.86||Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver reported worst pain over time.||||0.46
71124744|NCT01325714|141755658|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|1.43||||0.23|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|||Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver reported worst pain over time.||||0.23
71124745|NCT01325714|141755659|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|1.45||||0.23|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 455) = 1.45||Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver reported overall pain over time.||||0.23
71124746|NCT01325714|141755660|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|0.86||||0.62|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 409) = 0.59||Growth curve models were conducted to examine whether there were differences between treatment groups in change in patient-reported overall pain over time.||||0.62
71124747|NCT01325714|141755661|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|0.94||||0.42|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 453) = 0.94.||Growth curve models were conducted to examine whether there were differences between treatment groups in change in depression over time.||||0.42
71124748|NCT01325714|141755662|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|1.1||||0.35|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 457) = 1.10||Growth curve models were conducted to examine whether there were differences between treatment groups in change in pleasant events over time.||||0.35
71124749|NCT01325714|141755663|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|0.11||||0.11|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 456) = 2.00||Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver burden over time.||||0.11
71124750|NCT01325714|141755664|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|3.84||||0.01|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 456) = 3.84||Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver reported mutuality over time.||||0.01
71124751|NCT00721175|141755665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2407407|STANDARD_ERROR_OF_MEAN|0.0920078||0.011|TWO_SIDED|95.0|-0.4210726|-0.0604089|||Two-sample test of proportion|||||-.0604089|-.4210726|0.011
71124752|NCT00721175|141755666|SUPERIORITY_OR_OTHER|||||||0.0021||95.0|||||Log Rank|||||||0.0021
71124753|NCT00721175|141755668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.278744|STANDARD_ERROR_OF_MEAN|0.0929622||0.004|TWO_SIDED|95.0|-0.4609466|-0.0965414|||Two-sample test of proportion|||||-.0965414|-.4609466|0.004
71124754|NCT01064687|141755682|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.05|||<|0.001|TWO_SIDED|95.0|-1.22|-0.88||P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.88|-1.22|<0.001
71124755|NCT01064687|141755682|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.52|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.39||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.39|-0.66|<0.0001
71087181|NCT02674503|141680612|SUPERIORITY|||||||0.02||||||Linear fixed effect models adjusted for time in months|Regression, Linear|||||||0.02
71087182|NCT02674503|141680616|SUPERIORITY|||||||0.13|||||||Regression, Linear|Linear effects model adjusted for time (in months)||||||0.13
71087183|NCT02674503|141680618|SUPERIORITY|||||||0.02|||||||Regression, Linear|Linear mixed effects models adjusted for time (in months)||||||0.02
71087184|NCT02990000|141680649|SUPERIORITY|We used the Optimal Design program to determine the minimum numbers of therapists and patients needed to detect a moderate effect of condition (standardized difference between change rates = .50). Based on this a priori power analysis, we will need a total of 44 therapists and 211 patients to achieve a power of .80 to detect moderate condition effects. Factoring in a 25% dropout rate, enrolling 281 patients should provide sufficient statistical power.|condition effect on weekly change rate|-0.04|STANDARD_ERROR_OF_MEAN|0.01||0.02|TWO_SIDED|95.0|-0.05|-0.03|||3-level hierarchical linear model|||To account for the nested nature of the data (time points nested within patients nested within therapists), a 3-level hierarchical linear model was used to test the effect of condition (Scientific Match = 1; Pragmatic Match = 0) on weekly during-treatment change on the TOP-CS average z-scores. Given that higher TOP-CS z-scores indicate greater impairment, negative slopes indicate a weekly decrease in impairment during treatment (i.e., a better outcome or more improvement).||-0.03|-0.05|.02
71087185|NCT02990000|141680650|SUPERIORITY||condition effect on weekly change rate|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.03|TWO_SIDED|95.0|-0.3|-0.02|||3-level hierarchical linear model|||To account for the nested nature of the data (time points nested within patients nested within therapists), a 3-level hierarchical linear model was used to test the effect of condition (Scientific Match = 1; Pragmatic Match = 0) on weekly during-treatment change on the SCL-10 total score. Given that higher SCL-10 scores indicate greater psychological distress, negative slopes indicate a weekly decrease in impairment during treatment (i.e., a better outcome or more improvement).||-0.02|-0.30|.03
71087186|NCT02990000|141680651|SUPERIORITY||condition effect on weekly change rate|-0.07|STANDARD_ERROR_OF_MEAN|0.15||0.65|TWO_SIDED|95.0|-0.33|0.21|||3-level hierarchical linear model|||To account for the nested nature of the data (time points nested within patients nested within therapists), a 3-level hierarchical linear model was used to test the effect of condition (Scientific Match = 1; Pragmatic Match = 0) on weekly during-treatment change on the patient-rated WAI. Given that higher WAI scores indicate better quality therapeutic alliances, positive slopes indicate a weekly increase in alliance during treatment (i.e., a better outcome or more improvement).||0.21|-0.33|.65
71087187|NCT02990000|141680652|SUPERIORITY||condition effect on weekly change rate|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.41|TWO_SIDED|95.0|-0.17|0.07|||3-level hierarchical linear model|||To account for the nested nature of the data (time points nested within patients nested within therapists), a 3-level hierarchical linear model was used to test the effect of condition (Scientific Match = 1; Pragmatic Match = 0) on weekly during-treatment change on the OE subscale of the CEQ. Given that higher OE scores indicate more optimistic expectations, positive slopes indicate a weekly increase in OE during treatment (i.e., a better outcome or more improvement).||0.07|-0.17|.41
71087188|NCT02990000|141680653|SUPERIORITY||condition effect on weekly change rate|-0.01|STANDARD_ERROR_OF_MEAN|0.002||0.01|TWO_SIDED|95.0|-0.01|-0.006|||3-level hierarchical linear model|||To account for the nested nature of the data (time points nested within patients nested within therapists), a 3-level hierarchical linear model was used to test the effect of condition (Scientific Match = 1; Pragmatic Match = 0) on weekly during-treatment change on the log-transformed TOP-CS domain-specific z-scores. Given that higher z-scores indicate greater impairment, negative slopes indicate a weekly decrease in impairment during treatment (i.e., a better outcome or more improvement).||-0.006|-0.01|.01
71087189|NCT02990000|141680654|SUPERIORITY||Odds Ratio (OR)|1.3|STANDARD_ERROR_OF_MEAN|0.48||0.48|TWO_SIDED||||||Multilevel logistic regression|||Multilevel logistic regression analysis with patients nested within therapists (Scientific Match = 1; Pragmatic Match = 0). Statistically significant odds ratios that are greater than 1 would indicate that patients in the Scientific Match Condition were more likely to discontinue treatment early, whereas odds ratios that are less than 1 would indicate the opposite.||||.48
71087190|NCT02990000|141680655|SUPERIORITY||condition effect on satisfaction|0.37|STANDARD_ERROR_OF_MEAN|0.48||0.44|TWO_SIDED|95.0|-0.57|1.31|||2-level hierarchical linear model|||Due to the nested nature of the data (patients nested within therapists), we used a two-level hierarchical linear model to test the effect of condition on provider satisfaction at posttreatment. Because higher values indicate more satisfaction, a positive condition effect would indicate that Scientific Match patients were more satisfied than Pragmatic Match patients, whereas a negative condition effect would indicate the opposite.||1.31|-0.57|.44
71124756|NCT01064687|141755682|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.84|||<|0.001|TWO_SIDED|95.0|-1.01|-0.67||P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.67|-1.01|<0.001
71087191|NCT03268343|141680677|SUPERIORITY||Geometric LS Mean Ratio (%)|74.71|||||TWO_SIDED|90.0|66.39|84.08|||||fed / fasted; results obtained using an ANOVA with fixed effects of treatment, period, sequence and participant (sequence).|||84.08|66.39|
71087192|NCT03268343|141680678|SUPERIORITY||Geometric LS Mean Ratio (%)|97.04|||||TWO_SIDED|90.0|94.2|99.98|||||fed / fasted; results obtained using an ANOVA with fixed effects of treatment, period, sequence and participant (sequence).|||99.98|94.20|
71087193|NCT03268343|141680679|SUPERIORITY||Median Difference (Final Values)|1.38|||<|0.0001|TWO_SIDED|95.0|0.5|2.25|||Wilcoxon Signed-Rank test||Hodges-Lehmann method|||2.25|0.50|< 0.0001
71087194|NCT03268343|141680680|SUPERIORITY||Geometric LS Mean Ratio (%)|96.52|||||TWO_SIDED|90.0|93.3|99.85|||||fed / fasted; results obtained using an ANOVA with fixed effects of treatment, period, sequence and participant (sequence).|||99.85|93.30|
71087195|NCT03268343|141680684|SUPERIORITY||Geometric LS Mean Ratio (%)|104.75|||||TWO_SIDED|95.0|98.97|110.87|||||fed / fasted; results obtained using an ANOVA with fixed effects of treatment, period, sequence and participant (sequence).|||110.87|98.97|
71087196|NCT00496769|141680687|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|1e-05|TWO_SIDED|95.0|0.32|0.62|||Log Rank|||||0.62|0.32|<0.00001
71087197|NCT00496769|141680688|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.00026|TWO_SIDED|95.0|0.53|0.83|||Log Rank||Vascular death|||0.83|0.53|0.00026
71087198|NCT00496769|141680689|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.06782|TWO_SIDED|95.0|0.62|1.02|||Log Rank||All-cause death|||1.02|0.62|0.06782
70945364|NCT03463577|141391199|NON_INFERIORITY|The objective was to rule out a two-fold increase (non-inferiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis Ho: RR ≥ 2 was rejected if upper limit of the 98.75% CI for the adjusted RR was below 2.|Risk Ratio (RR)|1.38|||||TWO_SIDED|98.75|1.21|1.58|||||Adjusted relative risk with 98.75% CI was estimated by Poisson regression model|Demonstration of adjusted relative risk (RR) for pre-eclampsia and eclampsia in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was less than 2 (non-inferiority testing).||1.58|1.21|
70945365|NCT03463577|141391199|NON_INFERIORITY|The objective was to rule out a two-fold increase (non-inferiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis Ho: RR ≥ 2 was rejected if upper limit of the 98.75% CI for the adjusted RR was below 2.|Risk Ratio (RR)|1.28|||||TWO_SIDED|98.75|1.12|1.47|||||Adjusted relative risk with 98.75% CI was estimated by Poisson regression model|Demonstration of adjusted RR for intra-uterine infections (chorioamnionitis and endometritis) in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was less than 2 (non-inferiority testing).||1.47|1.12|
70945366|NCT03463577|141391200|NON_INFERIORITY|The objective was to rule out a two-fold increase (non-inferiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis Ho: RR ≥ 2 was rejected if upper limit of the 98.75% CI for the adjusted RR was below 2.|Risk Ratio (RR)|0.71|||||TWO_SIDED|98.75|0.64|0.78|||||Adjusted relative risk with 98.75% CI was estimated by Poisson regression model|Demonstration of adjusted RR for preterm delivery in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was less than 2 (non-inferiority testing).||0.78|0.64|
70945367|NCT03463577|141391201|NON_INFERIORITY|The objective was to rule out a two-fold increase (non-inferiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis Ho: RR ≥ 2 was rejected if upper limit of the 98.75% CI for the adjusted RR was below 2.|Risk Ratio (RR)|1.04|||||TWO_SIDED|98.75|0.94|1.16|||||Adjusted RR with 98.75% CI-Poisson regression model|Demonstration of adjusted RR for small for gestational age in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was less than 2 (non-inferiority testing).||1.16|0.94|
71087199|NCT00496769|141680689|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0028|TWO_SIDED|95.0|0.6|0.9|||Log Rank||Composite endpoint of major vascular events and major bleeding-net clinical benefit|||0.90|0.60|0.00280
71087200|NCT00496769|141680689|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.36586|TWO_SIDED|95.0|0.65|1.17|||Log Rank||Vascular death|||1.17|0.65|0.36586
71087201|NCT00496769|141680690|OTHER||Hazard Ratio (HR)|1.54||||0.0716|TWO_SIDED|95.0|0.96|2.45|||Log Rank||Major bleeding|||2.45|0.96|0.0716
71087202|NCT00496769|141680690|OTHER||Hazard Ratio (HR)|1.3||||0.0017|TWO_SIDED|95.0|1.1|1.53|||Log Rank||All bleeding|||1.53|1.10|0.0017
71087203|NCT00496769|141680690|OTHER||Hazard Ratio (HR)|1.38||||0.0144|TWO_SIDED|95.0|1.07|1.78|||Log Rank||Major or CNRM bleeding|||1.78|1.07|0.0144
71087204|NCT00496769|141680691|OTHER||Hazard Ratio (HR)|1.3||||0.0017|TWO_SIDED|95.0|1.1|1.53|||Log Rank|||||1.53|1.10|0.0017
71087205|NCT02812186|141680703|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
71087206|NCT02812186|141680704|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||||||0.28
71087207|NCT02812186|141680705|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
71087208|NCT01307787|141680706|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.002
71087209|NCT01307787|141680707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.47
71087210|NCT01307787|141680708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.24
71087211|NCT01307787|141680709|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.16
71087212|NCT01307787|141680710|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.21
71087213|NCT01307787|141680711|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.07
71087214|NCT01307787|141680712|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.4
71087215|NCT01307787|141680713|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.6
71087216|NCT01965327|141680747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027|TWO_SIDED||||||t-test, 2 sided|Missing data were imputed by last observation carried forward.||||||0.027
71087217|NCT01965327|141680748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0078|TWO_SIDED||||||t-test, 2 sided|||||||0.0078
71087218|NCT01507181|141680756|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||t-test, 2 sided|||||||0.32
71087219|NCT01507181|141680757|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED||||||t-test, 2 sided|||||||0.047
71087220|NCT01507181|141680758|SUPERIORITY_OR_OTHER|||||||0.17||||||Statistics are calculated by comparing 24-h scores using separate ANCOVAs and controlling for baseline severity.|ANCOVA|||||||0.17
71124757|NCT01064687|141755682|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.66|-0.39||P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.39|-0.66|<0.001
71124758|NCT01064687|141755682|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.44|-0.18||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.18|-0.44|<0.001
71124759|NCT01064687|141755682|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.44|-0.18||P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.18|-0.44|<0.001
71124760|NCT01064687|141755683|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.56|||<|0.001|TWO_SIDED|95.0|-0.73|-0.39||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.39|-0.73|<0.001
71124761|NCT01064687|141755683|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.27|||<|0.001|TWO_SIDED|95.0|-0.44|-0.11||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.11|-0.44|<0.001
70857007|NCT02446743|141200506|OTHER|Vaccine comparison-post-booster or post-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|12.0|||||TWO_SIDED|95.0|8.22|17.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||17|8.22|
71087221|NCT01669434|141680771|SUPERIORITY||Risk Ratio (RR)|0.81||||0.03|TWO_SIDED|95.0|0.67|0.97|||Fisher Exact|||||0.97|0.67|0.03
71124762|NCT01064687|141755683|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.56|||<|0.001|TWO_SIDED|95.0|-0.73|-0.39||P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.39|-0.73|<0.001
71087222|NCT01669434|141680772|SUPERIORITY||Risk Ratio (RR)|0.6||||0.44|TWO_SIDED|95.0|0.23|1.6|||Fisher Exact|||||1.60|0.23|0.44
71087223|NCT01669434|141680773|SUPERIORITY||Risk Ratio (RR)|1.2||||1|TWO_SIDED|95.0|0.48|2.99|||Fisher Exact|||||2.99|0.48|1.0
71087224|NCT01669434|141680774|SUPERIORITY||Risk Ratio (RR)|1.01||||1|TWO_SIDED|95.0|0.81|1.26|||Fisher Exact|||||1.26|0.81|1.0
71087225|NCT01669434|141680775|SUPERIORITY||Risk Ratio (RR)|1.95||||0.01|TWO_SIDED|95.0|1.14|3.34|||Fisher Exact|||||3.34|1.14|0.01
71087226|NCT01669434|141680776|SUPERIORITY||Risk Ratio (RR)|0.49||||0.02|TWO_SIDED|95.0|0.28|0.86|||Fisher Exact|||||0.86|0.28|0.02
71087227|NCT02860988|141680777|OTHER|Two-sided tests versus a margin|Mean Difference (Net)|0.6||||0.29|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Linear|||||||0.29
71087228|NCT02860988|141680778|OTHER|Two-sided tests versus a margin|Risk Difference (RD)|0.9||||0.88|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Logistic|||||||0.88
71087229|NCT02860988|141680779|OTHER|Two-sided tests versus a margin.|Risk Difference (RD)|0.96||||0.89|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Logistic|||||||0.89
71087230|NCT02860988|141680780|OTHER|Two-sided tests versus a margin.|Risk Difference (RD)|-4.26||||0.61|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Logistic|||||||0.61
71124763|NCT01064687|141755683|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.27|||<|0.001|TWO_SIDED|95.0|-0.44|-0.11||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.11|-0.44|<0.001
71124764|NCT01064687|141755684|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.72|||<|0.001|TWO_SIDED|95.0|-3.58|-1.85|||Mixed Models Analysis|||||-1.85|-3.58|<0.001
71124765|NCT01064687|141755684|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.571|TWO_SIDED|95.0|-0.88|0.49|||Mixed Models Analysis|||||0.49|-0.88|0.571
71124766|NCT01064687|141755684|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.19||||0.007|TWO_SIDED|95.0|-2.06|-0.33|||Mixed Models Analysis|||||-0.33|-2.06|0.007
71124767|NCT01064687|141755684|SUPERIORITY_OR_OTHER||LS Mean Difference|1.33|||<|0.001|TWO_SIDED|95.0|0.64|2.01|||Mixed Models Analysis|||||2.01|0.64|<0.001
71124768|NCT01064687|141755684|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.52|||<|0.001|TWO_SIDED|95.0|-3.39|-1.65|||Mixed Models Analysis|||||-1.65|-3.39|<0.001
71124769|NCT01064687|141755685|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32||||0.507|TWO_SIDED|95.0|-1.25|0.62|||Mixed Models Analysis|||||0.62|-1.25|0.507
71124770|NCT01064687|141755685|SUPERIORITY_OR_OTHER||LS Mean Difference|1.25||||0.009|TWO_SIDED|95.0|0.32|2.19|||Mixed Models Analysis|||||2.19|0.32|0.009
71124771|NCT01064687|141755686|SUPERIORITY_OR_OTHER||LS Means Difference|-0.97|||<|0.001|TWO_SIDED|95.0|-1.27|-0.67|||Mixed Models Analysis|||||-0.67|-1.27|<0.001
71124772|NCT01064687|141755686|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.568|TWO_SIDED|95.0|-0.31|0.17|||Mixed Models Analysis|||||0.17|-0.31|0.568
71124773|NCT01064687|141755686|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.42||||0.006|TWO_SIDED|95.0|-0.72|-0.12|||Mixed Models Analysis|||||-0.12|-0.72|0.006
70945368|NCT03463577|141391202|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. Superiority to be concluded if lower limit of the 95% CI for the adjusted RR is above 1.|Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.7|0.98|||||Adjusted RR with 95% CI -Poisson regression model|Assessment of adjusted RR for poor fetal growth in the Exposed pregnant women cohort (on or after 1st day of 27th week of pregnancy) compared to the Unexposed historical women cohort was 1 or differed from 1 (superiority testing).||0.98|0.70|
70945369|NCT03463577|141391202|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. Superiority to be concluded if lower limit of the 95% CI for the adjusted RR is above 1.|Risk Ratio (RR)|1.31|||||TWO_SIDED|95.0|0.99|1.72|||||Adjusted RR with 95% CI - Poisson regression model|Assessment of adjusted RR for placental abortion in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was 1 or differed from 1 (superiority testing).||1.72|0.99|
70945370|NCT03463577|141391202|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. Superiority to be concluded if lower limit of the 95% CI for the adjusted RR is above 1.|Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.64|0.91|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for preterm pre-labor rupture of membranes in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was 1 or differed from 1 (superiority testing).||0.91|0.64|
71087231|NCT02860988|141680781|OTHER|Two-sided tests versus a margin.|Risk Difference (RD)|3.61||||0.67|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Logistic|||||||0.67
71087232|NCT02860988|141680782|OTHER|Two-sided tests versus a margin.|Risk Difference (RD)|5.23||||0.14|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Logistic|||||||0.14
71087233|NCT02860988|141680783|OTHER|Two-sided tests versus a margin.|Mean Difference (Net)|0.03||||0.81|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Linear|||||||0.81
71087234|NCT02860988|141680784|OTHER|Two-sided tests versus a margin.|Mean Difference (Net)|0.31||||0.74|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Linear|||||||0.74
71087235|NCT00830219|141680806|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.53||||||90.0|99.16|108.09|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.09|99.16|
71087236|NCT00830219|141680807|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.3||||||90.0|97.56|107.27|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.27|97.56|
71087237|NCT00830219|141680808|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.54||||||90.0|97.53|107.8|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.8|97.53|
71087238|NCT01294423|141680809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.0853|<|0.0001|TWO_SIDED|95.0|-0.52|-0.18||significant at alpha=0.027 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) and gender as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.027 applying Dunnett's adjustment, two-sided)||-0.18|-0.52|<0.0001
71087239|NCT01294423|141680809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.0851|<|0.0001|TWO_SIDED|95.0|-0.56|-0.23||significant at alpha=0.027 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) and gender as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.027 applying Dunnett's adjustment, two-sided)||-0.23|-0.56|<0.0001
71087240|NCT01294423|141680810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.4|STANDARD_ERROR_OF_MEAN|2.902|<|0.0001|TWO_SIDED|95.0|-20.1|-8.7||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c at randomization by gender) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-8.7|-20.1|<0.0001
71124774|NCT01064687|141755686|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48|||<|0.001|TWO_SIDED|95.0|0.24|0.71|||Mixed Models Analysis|||||0.71|0.24|<0.001
71124775|NCT01064687|141755686|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|||<|0.001|TWO_SIDED|95.0|-1.2|-0.6|||Mixed Models Analysis|||||-0.60|-1.20|<0.001
71124776|NCT01064687|141755687|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09||||0.58|TWO_SIDED|95.0|-0.42|0.23|||Mixed Models Analysis|||||0.23|-0.42|0.580
71124777|NCT01064687|141755687|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46||||0.005|TWO_SIDED|95.0|0.14|0.79|||Mixed Models Analysis|||||0.79|0.14|0.005
71124778|NCT01064687|141755688|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.76|||<|0.001|TWO_SIDED|95.0|-34.5|-23.02|||Mixed Models Analysis|||||-23.02|-34.50|<0.001
71124779|NCT01064687|141755688|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.34|||<|0.001|TWO_SIDED|95.0|-13.62|-5.06|||Mixed Models Analysis|||||-5.06|-13.62|<0.001
70857008|NCT02446743|141200506|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|3.04|||||TWO_SIDED|95.0|2.2|4.2|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||4.20|2.20|
70857009|NCT02446743|141200506|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|11.0|||||TWO_SIDED|95.0|7.75|16.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||16|7.75|
70945371|NCT03463577|141391203|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR =1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|0.38|||||TWO_SIDED|95.0|0.22|0.67|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for stillbirth/fetal death in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was 1 or differed from 1 (superiority testing).||0.67|0.22|
71124780|NCT01064687|141755688|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.02|||<|0.001|TWO_SIDED|95.0|-29.8|-18.24|||Mixed Models Analysis|||||-18.24|-29.80|<0.001
71124781|NCT01064687|141755688|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.61||||0.038|TWO_SIDED|95.0|-8.95|-0.27|||Mixed Models Analysis|||||-0.27|-8.95|0.038
71124782|NCT01064687|141755688|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.41|||<|0.001|TWO_SIDED|95.0|-25.18|-13.65|||Mixed Models Analysis|||||-13.65|-25.18|<0.001
71124783|NCT01064687|141755689|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.68||||0.004|TWO_SIDED|95.0|-12.84|-2.52|||Mixed Models Analysis|||||-2.52|-12.84|0.004
71124784|NCT01064687|141755689|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.47||||0.092|TWO_SIDED|95.0|-9.66|0.73|||Mixed Models Analysis|||||0.73|-9.66|0.092
71124785|NCT01064687|141755690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.1|||<|0.001|TWO_SIDED|95.0|7.4|23.4||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||23.4|7.4|<0.001
71124786|NCT01064687|141755690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.2|||<|0.001|TWO_SIDED|95.0|3.9|10.1||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||10.1|3.9|<0.001
71124787|NCT01064687|141755690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.8|||<|0.001|TWO_SIDED|95.0|2.8|8.0||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||8.0|2.8|<0.001
71124788|NCT01064687|141755690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.5|3.5||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||3.5|1.5|<0.001
71124789|NCT01064687|141755690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1||||0.004|TWO_SIDED|95.0|1.3|3.5||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||3.5|1.3|0.004
71124790|NCT01064687|141755690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.8|||<|0.001|TWO_SIDED|95.0|6.7|20.8||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||20.8|6.7|<0.001
71124791|NCT01064687|141755690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.001|TWO_SIDED|95.0|2.9|6.8||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||6.8|2.9|<0.001
71124792|NCT01064687|141755690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.3|||<|0.001|TWO_SIDED|95.0|3.7|10.9||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||10.9|3.7|<0.001
71124793|NCT01064687|141755690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|||<|0.001|TWO_SIDED|95.0|1.6|3.5||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||3.5|1.6|<0.001
71124794|NCT01064687|141755690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.7|||<|0.001|TWO_SIDED|95.0|1.6|4.6||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||4.6|1.6|<0.001
71124795|NCT01064687|141755691|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.7|||<|0.001|TWO_SIDED|95.0|2.4|5.6||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||5.6|2.4|<0.001
71124796|NCT01064687|141755691|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.008|TWO_SIDED|95.0|1.1|2.5||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||2.5|1.1|0.008
71124797|NCT01064687|141755691|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.5|||<|0.001|TWO_SIDED|95.0|2.3|5.1||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||5.1|2.3|<0.001
71124798|NCT01064687|141755691|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||<|0.001|TWO_SIDED|95.0|1.4|3.1||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||3.1|1.4|<0.001
71124799|NCT01064687|141755692|SUPERIORITY_OR_OTHER||LS Mean Difference|35.21|||<|0.001|TWO_SIDED|95.0|27.26|43.16||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||43.16|27.26|<0.001
71124800|NCT01064687|141755692|SUPERIORITY_OR_OTHER||LS Mean Difference|21.12|||<|0.001|TWO_SIDED|95.0|14.97|27.28||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||27.28|14.97|<0.001
71124801|NCT01064687|141755692|SUPERIORITY_OR_OTHER||LS Mean Difference|22.68|||<|0.001|TWO_SIDED|95.0|14.63|30.72||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||30.72|14.63|<0.001
71124802|NCT01064687|141755692|SUPERIORITY_OR_OTHER||LS Mean Difference|8.59||||0.007|TWO_SIDED|95.0|2.31|14.87||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||14.87|2.31|0.007
71124803|NCT01064687|141755692|SUPERIORITY_OR_OTHER||LS Mean Difference|14.09|||<|0.001|TWO_SIDED|95.0|6.06|22.11||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||22.11|6.06|<0.001
71124804|NCT01064687|141755692|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.7||||0.207|TWO_SIDED|95.0|-14.56|3.17||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||3.17|-14.56|0.207
71124805|NCT01064687|141755692|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.54||||0.659|TWO_SIDED|95.0|-8.41|5.32||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||5.32|-8.41|0.659
71124806|NCT01064687|141755692|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4||||0.759|TWO_SIDED|95.0|-10.37|7.56||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||7.56|-10.37|0.759
71124807|NCT01064687|141755692|SUPERIORITY_OR_OTHER||LS Mean Difference|2.75||||0.441|TWO_SIDED|95.0|-4.25|9.76||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||9.76|-4.25|0.441
71124808|NCT01064687|141755692|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.15||||0.362|TWO_SIDED|95.0|-13.1|4.79||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||4.79|-13.10|0.362
71124809|NCT01064687|141755693|SUPERIORITY_OR_OTHER||LS Mean Difference|21.64|||<|0.001|TWO_SIDED|95.0|15.2|28.08||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||28.08|15.20|<0.001
71124810|NCT01064687|141755693|SUPERIORITY_OR_OTHER||LS Mean Difference|12.12|||<|0.001|TWO_SIDED|95.0|5.56|18.68||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||18.68|5.56|<0.001
71124811|NCT01064687|141755693|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.73||||0.307|TWO_SIDED|95.0|-10.9|3.43||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||3.43|-10.90|0.307
70945372|NCT03463577|141391203|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.07|||||TWO_SIDED|95.0|0.86|1.33|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for transfusion during delivery hospitalization in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was 1 or differed from 1 (superiority testing).||1.33|0.86|
70945373|NCT03463577|141391204|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.38|1.73|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for neonatal death in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.73|0.38|
70945374|NCT03463577|141391204|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.35|||||TWO_SIDED|95.0|0.81|2.24|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of nervous system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||2.24|0.81|
71124812|NCT01064687|141755693|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.75||||0.638|TWO_SIDED|95.0|-9.05|5.55||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||5.55|-9.05|0.638
71124813|NCT02299076|141755729|SUPERIORITY|Welch Two Sample t-test|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71124814|NCT01969721|141755731|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.125|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.103|0.147||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 250/50 adjusted mean FEV1 AUC 0-12h change from patient baseline (L)|"Null hypothesis: Mean FEV1 AUC 0-12h change from patient baseline (Tiotropium + Olodaterol 5/5 µg) = Mean FEV1 AUC 0-12h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 µg).~Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect."||0.147|0.103|<0.0001
71124815|NCT01969721|141755731|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.129|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.107|0.15||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 500/50 adjusted mean FEV1 AUC 0-12h change from patient baseline (L)|"Null hypothesis: Mean FEV1 AUC 0-12h change from patient baseline (Tiotropium + Olodaterol 5/5 µg) = Mean FEV1 AUC 0-12h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 µg).~Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect."||0.150|0.107|<0.0001
71124816|NCT01969721|141755731|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.103|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001||95.0|0.081|0.124||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 250/50 adjusted mean FEV1 AUC 0-12h change from patient baseline (L)|"Null hypothesis: Mean FEV1 AUC 0-12h change from patient baseline (Tiotropium + Olodaterol 2.5/5 µg) = Mean FEV1 AUC 0-12h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 µg).~Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect."||0.124|0.081|<0.0001
71124817|NCT01969721|141755731|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.106|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.085|0.128||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 500/50 adjusted mean FEV1 AUC 0-12h change from patient baseline (L)|"Null hypothesis: Mean FEV1 AUC 0-12h change from patient baseline (Tiotropium + Olodaterol 2.5/5 µg) = Mean FEV1 AUC 0-12h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 µg).~Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect."||0.128|0.085|<0.0001
70945375|NCT03463577|141391204|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.17|||||TWO_SIDED|95.0|1.06|1.29|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of eye in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.29|1.06|
70945376|NCT03463577|141391204|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|2.02|||||TWO_SIDED|95.0|1.59|2.55|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of ear, face or neck in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing.||2.55|1.59|
70945377|NCT03463577|141391204|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.12|||||TWO_SIDED|95.0|0.96|1.31|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of cardiovascular system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infant cohort was 1 or differed from 1 (superiority testing).||1.31|0.96|
70945378|NCT03463577|141391204|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.34|||||TWO_SIDED|95.0|1.07|1.68|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of respiratory system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was1 or differed from 1 (superiority testing).||1.68|1.07|
70945379|NCT03463577|141391204|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.41||||||95.0|0.78|2.57|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for clefts in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||2.57|0.78|
70945380|NCT03463577|141391204|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.75|||||TWO_SIDED|95.0|1.57|1.95|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of upper gastrointestinal system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.95|1.57|
71124818|NCT01969721|141755732|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.082|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.061|0.103||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 250/50 adjusted mean FEV1 AUC 0-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 0-24h change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 AUC 0-24h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.103|0.061|<0.0001
71124819|NCT01969721|141755732|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.086|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.065|0.107||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 500/50 adjusted mean FEV1 AUC 0-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 0-24h change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 AUC 0-24h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.107|0.065|<0.0001
71124820|NCT01969721|141755732|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.065|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.045|0.086||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 250/50 adjusted mean FEV1 AUC 0-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 0-24h change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 AUC 0-24h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.086|0.045|<0.0001
71124821|NCT01969721|141755732|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.069|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.048|0.09||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 500/50 adjusted mean FEV1 AUC 0-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 0-24h change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 AUC 0-24h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.090|0.048|<0.0001
71124822|NCT01969721|141755733|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.047|STANDARD_ERROR_OF_MEAN|0.012||0.0002|TWO_SIDED|95.0|0.022|0.071||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 250/50 adjusted mean trough FEV1 change from patient baseline (L)|Null hypothesis: Mean trough FEV1 change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean trough FEV1 change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.071|0.022|0.0002
71124823|NCT01969721|141755733|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.058|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.034|0.082||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 500/50 adjusted mean trough FEV1 change from patient baseline (L)|Null hypothesis: Mean trough FEV1 change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean trough FEV1 change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.082|0.034|<0.0001
70857010|NCT02446743|141200506|OTHER|"Vaccine comparison Pre-booster or pre-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|16.0|||||TWO_SIDED|95.0|12.0|21.0|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||21|12|
70857011|NCT02446743|141200506|OTHER|"Vaccine comparison Post-booster or post-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|68.0|||||TWO_SIDED|95.0|51.0|90.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||90|51|
70857012|NCT02446743|141200506|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|18.0|||||TWO_SIDED|95.0|13.0|26.0|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||26|13|
70857013|NCT02446743|141200506|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|74.0|||||TWO_SIDED|95.0|51.0|107.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||107|51|
70857014|NCT02446743|141200506|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|14.0|||||TWO_SIDED|95.0|8.99|22.0|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||22|8.99|
70857015|NCT02446743|141200506|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|63.0|||||TWO_SIDED|95.0|41.0|95.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||95|41|
70857016|NCT02446743|141200506|OTHER|"Vaccine comparison Pre-booster or pre-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|1.48|||||TWO_SIDED|95.0|1.24|1.75|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||1.75|1.24|
70857017|NCT02446743|141200506|OTHER|"Vaccine comparison Post-booster or post-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|5.9|||||TWO_SIDED|95.0|4.49|7.76|||ANOVA|||Post booster dose/ post first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||7.76|4.49|
70857018|NCT02446743|141200506|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|1.32|||||TWO_SIDED|95.0|1.13|1.54|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||1.54|1.13|
70857019|NCT02446743|141200506|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|8.27|||||TWO_SIDED|95.0|5.83|12.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||12|5.83|
70857020|NCT02446743|141200506|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|1.64|||||TWO_SIDED|95.0|1.22|2.2|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||2.20|1.22|
70945381|NCT03463577|141391204|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|0.63|||||TWO_SIDED|95.0|0.36|1.12|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of lower gastrointestinal system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.12|0.36|
70857021|NCT02446743|141200506|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|4.36|||||TWO_SIDED|95.0|2.88|6.58|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||6.58|2.88|
70857022|NCT02446743|141200506|OTHER|"Vaccine comparison Pre-booster or pre-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|1.3|||||TWO_SIDED|95.0|0.97|1.75|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||1.75|0.97|
71087241|NCT01294423|141680810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5|STANDARD_ERROR_OF_MEAN|2.892|<|0.0001|TWO_SIDED|95.0|-25.2|-13.8||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c at randomization by gender) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-13.8|-25.2|<0.0001
71087242|NCT01294423|141680811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|0.3533||0.0003|TWO_SIDED|95.0|-1.98|-0.59||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c at randomization by gender) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.59|-1.98|0.0003
71087243|NCT01294423|141680811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|0.354||0.0001|TWO_SIDED|95.0|-2.08|-0.69||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c at randomization by gender) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.69|-2.08|0.0001
71087244|NCT01868646|141680893|SUPERIORITY|||||||0.0002||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.0002
71087245|NCT01868646|141680894|SUPERIORITY|||||||0.0426||||||"The p-value associated with treatment factor of changes from baseline to Week 4, 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.0426
71087246|NCT01868646|141680895|SUPERIORITY|||||||0.599||||||"The p-value associated with treatment factor of changes from baseline to Week 4, 8, 12, 18, 24, 30 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.5990
71087247|NCT01868646|141680896|SUPERIORITY|||||||0.6215||||||"The p-value associated with treatment factor of mean value at baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.6215
71087248|NCT01868646|141680897|SUPERIORITY|||||||0.6155||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of Total cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.6155
71087249|NCT01868646|141680897|SUPERIORITY|||||||0.7507||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of HDL cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.7507
70857023|NCT02446743|141200506|OTHER|"Vaccine comparison Post-booster or post-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|2.6|||||TWO_SIDED|95.0|2.08|3.25|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||3.25|2.08|
71087250|NCT01868646|141680897|SUPERIORITY|||||||0.4195||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of LDL cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.4195
71087251|NCT01868646|141680897|SUPERIORITY|||||||0.3609||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of Triglycerides changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.3609
71087252|NCT01868646|141680898|SUPERIORITY|||||||0.0605|||||||t-test, 2 sided|||||||0.0605
71087253|NCT01868646|141680899|SUPERIORITY|||||||0.0726|||||||t-test, 2 sided|||||||0.0726
71087254|NCT01868646|141680900|SUPERIORITY|||||||0.3108|||||||Fisher Exact|||||||0.3108
71087255|NCT01868646|141680901|SUPERIORITY|||||||0.2934|||||||t-test, 2 sided|||||||0.2934
71087256|NCT01868646|141680902|SUPERIORITY|||||||0.341|||||||t-test, 2 sided|||||||0.3410
71087257|NCT01868646|141680903|SUPERIORITY|||||||0.1577|||||||t-test, 2 sided|||Satisfaction||||0.1577
71087258|NCT01868646|141680903|SUPERIORITY|||||||0.5262|||||||t-test, 2 sided|||Hyperglycemia||||0.5262
71087259|NCT01868646|141680903|SUPERIORITY|||||||0.7417|||||||t-test, 2 sided|||Hypoglycemia||||0.7417
71087260|NCT03843372|141680916|SUPERIORITY||||||<|0.001|||||||Wilcoxon rank sum test|||The AHI was not a normal distribution. In the event that no carry over effect was detected between interventions, a Wilcoxon rank sum test was to be used to compare AHI between CPAP and HFNC||||<0.001
71087261|NCT03843372|141680917|SUPERIORITY||||||<|0.001|||||||Wilcoxon rank sum test|||The oxygen desaturation index was not a normal distribution. In the event that no carry over effect was detected between interventions, a Wilcoxon rank sum test was to be used to compare oxygen desaturation index between CPAP and HFNC||||<0.001
71087262|NCT03843372|141680918|SUPERIORITY||||||<|0.001|||||||Wilcoxon rank sum test|||The total sleep time was not a normal distribution. In the event that no carry over effect was detected between interventions, a Wilcoxon rank sum test was to be used to compare total sleep time between CPAP and HFNC||||<0.001
70857024|NCT02446743|141200506|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|1.4|||||TWO_SIDED|95.0|0.9|2.18|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||2.18|0.90|
70857025|NCT02446743|141200506|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|2.79|||||TWO_SIDED|95.0|2.04|3.81|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||3.81|2.04|
71124824|NCT01969721|141755733|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.042|STANDARD_ERROR_OF_MEAN|0.012||0.0007|TWO_SIDED|95.0|0.018|0.067||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 250/50 adjusted mean trough FEV1 change from patient baseline (L)|Null hypothesis: Mean trough FEV1 change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean trough FEV1 change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.067|0.018|0.0007
71124825|NCT01969721|141755733|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.054|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.029|0.078||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 500/50 adjusted mean trough FEV1 change from patient baseline (L)|Null hypothesis: Mean trough FEV1 change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean trough FEV1 change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.078|0.029|<0.0001
71124826|NCT01969721|141755734|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.039|STANDARD_ERROR_OF_MEAN|0.012||0.0007|TWO_SIDED|95.0|0.017|0.062||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated T+O 5/5 - F+S 250/50 adjusted mean FEV1 AUC 12-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 12-24h change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 AUC 12-24h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.062|0.017|0.0007
70857026|NCT02446743|141200506|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|1.23|||||TWO_SIDED|95.0|0.82|1.82|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||1.82|0.82|
71124827|NCT01969721|141755734|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.043|STANDARD_ERROR_OF_MEAN|0.011||0.0002|TWO_SIDED|95.0|0.021|0.065||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 500/50 adjusted mean FEV1 AUC 12-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 12-24h change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 AUC 12-24h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.065|0.021|0.0002
71124828|NCT01969721|141755734|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.028|STANDARD_ERROR_OF_MEAN|0.011||0.0146|TWO_SIDED|95.0|0.006|0.051||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 250/50 adjusted mean FEV1 AUC 12-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 12-24h change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 AUC 12-24h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.051|0.006|0.0146
71124829|NCT01969721|141755734|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.032|STANDARD_ERROR_OF_MEAN|0.011||0.0055|TWO_SIDED|95.0|0.009|0.054||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 500/50 adjusted mean FEV1 AUC 12-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 12-24h change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 AUC 12-24h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.054|0.009|0.0055
71124830|NCT01969721|141755735|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.142|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.118|0.166||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 250/50 adjusted mean FEV1 peak (0-3h) change from patient baseline (L)|Null hypothesis: Mean FEV1 peak (0-3h) change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 peak (0-3h) change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.166|0.118|<0.0001
71124831|NCT01969721|141755735|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.147|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.123|0.171||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 500/50 adjusted mean FEV1 peak (0-3h) change from patient baseline (L)|Null hypothesis: Mean FEV1 peak (0-3h) change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 peak (0-3h) change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.171|0.123|<0.0001
71124832|NCT01969721|141755735|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.111|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.087|0.135||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 250/50 adjusted mean FEV1 peak (0-3h) change from patient baseline (L)|Null hypothesis: Mean FEV1 peak (0-3h) change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 peak (0-3h) change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.135|0.087|<0.0001
71124833|NCT01969721|141755735|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.116|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.092|0.14||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 500/50 adjusted mean FEV1 peak (0-3h) change from patient baseline (L)|Null hypothesis: Mean FEV1 peak (0-3h) change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 peak (0-3h) change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.140|0.092|<0.0001
71124834|NCT02117349|141755755|OTHER||Odds Ratio (OR)|42.8|||=|0.001|TWO_SIDED|95.0|4.58|401.0||Study was terminated early at 55 randomized subjects, therefore p-value is considered nominal|Regression, Logistic|||Odds Ratio (OR) and Wald-based 95% Confidence intervals (CIs) are from logistic regression model comparing the response between treatment arms.||401.0|4.58|= 0.0010
70857027|NCT02446743|141200506|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|2.45|||||TWO_SIDED|95.0|1.79|3.36|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||3.36|1.79|
70857028|NCT02446743|141200508|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|27.0|||||TWO_SIDED|95.0|20.7|33.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||33.0|20.7|
70857029|NCT02446743|141200508|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41) Difference|Vaccine group difference|29.0|||||TWO_SIDED|95.0|19.3|38.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||38.7|19.3|
70857030|NCT02446743|141200508|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10) Difference|Vaccine group difference|26.0|||||TWO_SIDED|95.0|18.3|33.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||33.9|18.3|
70857031|NCT02446743|141200508|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|22.0|||||TWO_SIDED|95.0|15.9|27.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval or the difference was calculated using the method of Miettinen and Nurminen||27.9|15.9|
70857032|NCT02446743|141200508|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41) Difference|Vaccine group difference|19.0|||||TWO_SIDED|95.0|11.5|28.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||28.5|11.5|
70857033|NCT02446743|141200508|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10) Difference|Vaccine group difference|23.0|||||TWO_SIDED|95.0|14.6|31.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||31.9|14.6|
70857034|NCT02446743|141200508|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|38.0|||||TWO_SIDED|95.0|29.8|45.4|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||45.4|29.8|
70857035|NCT02446743|141200508|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41) Difference|Vaccine group difference|55.0|||||TWO_SIDED|95.0|43.5|64.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||64.7|43.5|
71087263|NCT03843372|141680919|SUPERIORITY|||||||0.008|||||||Wilcoxon rank sum test|||The sleep efficiency was not a normal distribution. In the event that no carry over effect was detected between interventions, a Wilcoxon rank sum test was to be used to compare sleep efficiency between CPAP and HFNC||||0.008
71124835|NCT02265796|141755761|SUPERIORITY||||||>|0.05||||||the reported p value is for all between group comparisons of the SAQ domains.|t-test, 2 sided|||between group comparison for all SAQ domains||||>0.05
71124836|NCT02265796|141755761|SUPERIORITY||||||>|0.05||||||reported p value is for the physical limitation, angina frequency and treatment satisfaction domains|paired t test|||within group comparison of change from baseline||||>0.05
71124837|NCT02265796|141755761|SUPERIORITY||||||<|0.05||||||reported p value is for the angina stability and quality of life domains|paired t test|||within group comparison of change from baseline||||<0.05
71124838|NCT02265796|141755761|SUPERIORITY||||||>|0.05||||||reported p value is for the physical limitation and treatment satisfaction domains|paired t test|||within group comparison of change from baseline||||>0.05
71124839|NCT02265796|141755761|SUPERIORITY||||||<|0.05||||||reported p value is for the angina stability, angina frequency and quality of life domains|paired t test|||within group comparison of change from baseline||||<0.05
71124840|NCT02265796|141755762|SUPERIORITY|||||||0.58|||||||Fisher Exact|||"between group comparison for the excellent/good"||||0.58
71124841|NCT02265796|141755762|SUPERIORITY|||||||0.8|||||||Fisher Exact|||"Between group analysis for fair/poor"||||0.80
71124842|NCT02265796|141755762|SUPERIORITY|||||||0.5|||||||McNemar|||within group analysis of change from baseline for excellent/good||||0.50
71124843|NCT02265796|141755762|SUPERIORITY|||||||0.48|||||||McNemar|||within group comparison of change from baseline for fair/poor||||0.48
71124844|NCT02265796|141755762|SUPERIORITY|||||||0.19|||||||McNemar|||within group analysis of change from baseline for excellent/good||||0.19
71124845|NCT02265796|141755762|SUPERIORITY|||||||0.067|||||||McNemar|||within group comparison of change from baseline for fair/poor||||0.067
71124846|NCT02265796|141755763|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
71124847|NCT02963701|141755772|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%|T/R Ratio (%)|99.16|STANDARD_DEVIATION|8.49|||TWO_SIDED|90.0|96.52|101.89|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||101.89|96.52|
71124848|NCT02963701|141755773|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%|T/R Ratio (%)|89.16|STANDARD_DEVIATION|19.28|||TWO_SIDED|90.0|83.88|94.76|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||94.76|83.88|
71124849|NCT02963701|141755774|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|99.75|STANDARD_DEVIATION|12.96|||TWO_SIDED|90.0|95.73|103.95|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios \[%\] of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation \[%\].|||103.95|95.73|
71124850|NCT02963701|141755775|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|102.16|STANDARD_DEVIATION|15.37|||TWO_SIDED|90.0|97.3|107.27|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios \[%\] of Test and Reference products. The parameter dispersion type \[SD\] was actually the intra-individual geometric coefficient of variation \[%\].|||107.27|97.30|
71124851|NCT02963701|141755776|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|98.97|STANDARD_DEVIATION|8.13|||TWO_SIDED|90.0|96.44|101.57|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%)of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||101.57|96.44|
71124852|NCT02963701|141755777|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|99.67|STANDARD_DEVIATION|13.5|||TWO_SIDED|90.0|95.48|104.04|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||104.04|95.48|
71124853|NCT02963701|141755778|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|95.96|STANDARD_DEVIATION|14.27|||TWO_SIDED|90.0|91.7|100.4|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||100.40|91.70|
71124854|NCT02963701|141755779|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|96.12|STANDARD_DEVIATION|14.06|||TWO_SIDED|90.0|91.92|100.51|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||100.51|91.92|
70857036|NCT02446743|141200508|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10) Difference|Vaccine group difference|24.0|||||TWO_SIDED|95.0|12.9|35.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||35.1|12.9|
70857037|NCT02446743|141200508|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|23.0|||||TWO_SIDED|95.0|14.7|30.8|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||30.8|14.7|
70857038|NCT02446743|141200508|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41) Difference|Vaccine group difference|24.0|||||TWO_SIDED|95.0|12.2|35.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||35.5|12.2|
70857039|NCT02446743|141200508|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10) Difference|Vaccine group difference|22.0|||||TWO_SIDED|95.0|10.6|32.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||32.9|10.6|
70945382|NCT03463577|141391204|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.19|||||TWO_SIDED|95.0|1.01|1.42|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of genital organs in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.42|1.01|
71087264|NCT02337062|141680920|SUPERIORITY||||||<|0.001||||||The threshold for determining statistical significance in the comparison of incidence of success between the active and placebo groups (the primary efficacy analysis) was a p-value of 2.5% one-sided.|Chi-squared|||The primary efficacy analysis was a comparison of the incidence of the primary efficacy variable between the two groups that received APD421 and the group that received placebo, using Pearson's χ2 test.||||<0.001
71087265|NCT02337062|141680921|SUPERIORITY|||||||0.003|||||||Chi-squared|||||||0.003
71087266|NCT02337062|141680922|SUPERIORITY|||||||0.002|||||||Chi-squared|||||||0.002
71087267|NCT02337062|141680923|SUPERIORITY|||||||0.002|||||||Chi-squared|||||||0.002
71087268|NCT02337062|141680924|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
70857040|NCT02446743|141200509|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|Vaccine group difference|-6.0|||||TWO_SIDED|95.0|-15.0|4.5||Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||4.5|-15.0|
71087269|NCT02337062|141680925|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
71087270|NCT03238417|141680955|NON_INFERIORITY|Analysis of Variance comparing change in outcome between EBQI and control from baseline to 12 month.|Mean Difference (Net)|-0.65|STANDARD_ERROR_OF_MEAN|1.32||0.623|TWO_SIDED|95.0|-3.3|2.0||P-value is from the interaction term between EBQI and time.|ANOVA|||||2.0|-3.3|0.623
71087271|NCT03238417|141680956|NON_INFERIORITY|Analysis of Variance testing for change in outcome between EBQI and control from baseline to 24 months.|Mean Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|1.1||0.678|TWO_SIDED|95.0|-2.8|1.8||P-value is from the interaction term of EBQI and time.|ANOVA|||||1.8|-2.8|0.678
71124855|NCT02963701|141755780|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|90.83|STANDARD_DEVIATION|21.49|||TWO_SIDED|90.0|84.87|97.21|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||97.21|84.87|
71124856|NCT02963701|141755781|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|101.86|STANDARD_DEVIATION|7.89|||TWO_SIDED|90.0|99.33|104.46|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||104.46|99.33|
71124857|NCT02963701|141755782|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|101.65|STANDARD_DEVIATION|7.01|||TWO_SIDED|90.0|99.4|103.95|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||103.95|99.40|
71124858|NCT02963701|141755783|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|86.53|STANDARD_DEVIATION|16.85|||TWO_SIDED|90.0|82.03|91.28|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||91.28|82.03|
71124859|NCT02963701|141755784|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|Ratio (%)|106.17|STANDARD_DEVIATION|14.77|||TWO_SIDED|90.0|101.3|111.26|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||111.26|101.30|
71087272|NCT03238417|141680957|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for age, how often they saw women patients in the past year, location of practice in primary care or women's health clinic, and having had any type of quality improvement training. We adjusted our analysis with non-response weights.|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.13||0.364|TWO_SIDED|95.0|-0.17|0.35||P-value is from the interaction term between EBQI and time, adjusted for non-response weights and characteristics described in the statistical analysis overview.|Regression, Linear||The estimated value reported here is the predicted mean change from baseline to 12-month, adjusting for characteristics described in the statistical analysis overview.|Change in gender awareness score between EBQI and control from baseline to 12-month||0.35|-0.17|0.364
71087273|NCT03238417|141680958|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for age, how often they saw women patients in the past year, location of practice in primary care or women's health clinic, and having had any type of quality improvement training. We adjusted our analysis with non-response weights.|Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.1||0.29|TWO_SIDED|95.0|-0.33|0.1||P-value reflects the interaction term between EBQI and time, adjusted for non-response weights and characteristics described in the statistical analysis overview.|Regression, Linear||The estimated value reported here is the predicted mean change from baseline to 24-month, adjusting for characteristics described in the statistical analysis overview.|Change in gender awareness score between EBQI and control from baseline to 24-month||0.10|-0.33|0.29
70857041|NCT02446743|141200509|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|Vaccine group difference|-4.0|||||TWO_SIDED|95.0|-17.0|11.4|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||11.4|-17.0|
70857042|NCT02446743|141200509|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|Vaccine group difference|-8.0|||||TWO_SIDED|95.0|-20.0|7.3|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||7.3|-20.0|
70857043|NCT02446743|141200509|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-0.9|6.2|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||6.2|-0.9|
71124860|NCT02227394|141755877|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|-0.187||||0.727|TWO_SIDED|90.0|-1.098|0.724|||t-test, 2 sided|||||0.724|-1.098|0.727
70857044|NCT02446743|141200509|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.6|8.8|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.8|-3.6|
71124861|NCT02227394|141755878|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.003||||0.366|TWO_SIDED|90.0|-0.002|0.007|||t-test, 2 sided|||||0.007|-0.002|0.366
71124862|NCT02227394|141755880|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.025||||0.486|TWO_SIDED|90.0|-0.035|0.084|||t-test, 2 sided|||||0.084|-0.035|0.486
71124863|NCT02227394|141755881|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.049||||0.413|TWO_SIDED|90.0|-0.052|0.15|||t-test, 2 sided|||||0.150|-0.052|0.413
71124864|NCT02227394|141755882|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|-0.1||||0.375|TWO_SIDED|90.0|-0.289|0.09|||t-test, 2 sided|||||0.090|-0.289|0.375
71124865|NCT02227394|141755883|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.009||||0.879|TWO_SIDED|90.0|-0.092|0.11|||t-test, 2 sided|||||0.110|-0.092|0.879
71124866|NCT02227394|141755884|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.023||||0.819|TWO_SIDED|90.0|-0.149|0.195|||t-test, 2 sided|||||0.195|-0.149|0.819
71124867|NCT02227394|141755885|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|-0.4||||0.643|TWO_SIDED|90.0|-1.87|1.07|||t-test, 2 sided|||||1.070|-1.870|0.643
71124868|NCT02227394|141755886|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.011||||0.866|TWO_SIDED|90.0|-0.1|0.122|||t-test, 2 sided|||||0.122|-0.100|0.866
71124869|NCT02227394|141755887|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.054||||0.346|TWO_SIDED|90.0|-0.043|0.152|||t-test, 2 sided|||||0.152|-0.043|0.346
71124870|NCT02227394|141755888|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.029||||0.093|TWO_SIDED|90.0|0.001|0.058|||t-test, 2 sided|||||0.058|0.001|0.093
71124871|NCT02227394|141755889|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|-0.074||||0.686|TWO_SIDED|90.0|-0.386|0.238|||t-test, 2 sided|||||0.238|-0.386|0.686
71124872|NCT02227394|141755891|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|-10.368||||0.312|TWO_SIDED|90.0|-27.659|6.922|||t-test, 2 sided|||||6.922|-27.659|0.312
70857045|NCT02446743|141200509|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|Vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.5|11.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||11.0|-2.5|
70857046|NCT02446743|141200509|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1(V72\_41) (1 month after booster or 2nd dose)|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.6|4.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.4|-3.6|
70857047|NCT02446743|141200509|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|Vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.3|7.8|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||7.8|-2.3|
71087274|NCT03238417|141680959|SUPERIORITY|Difference-in-differences analysis using logistic regression. The number of activities were recoded into 0 vs 1+ activities. The model was adjusted for age, how often they saw women patients in the past year, location of practice in primary care or women's health clinic, and having had any type of quality improvement training. We also adjusted for non-response weights.|Odds Ratio (OR)|-0.69|STANDARD_ERROR_OF_MEAN|0.42||0.1|TWO_SIDED|95.0|-1.52|0.13||P-value is from the interaction term between EBQI and time, adjusted for non-response weights and characteristics described in the statistical analysis overview.|Difference-in-Differences analysis||The estimated value is predicted change in the odds of involving in one or more quality improvement activities, adjusting for characteristics described in the statistical analysis overview.|||0.13|-1.52|0.10
70857048|NCT02446743|141200509|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-0.9|4.1|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.1|-0.9|
70857049|NCT02446743|141200509|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|Vaccine group difference|-20.0|||||TWO_SIDED|95.0|-35.2|-7.5|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-7.5|-35.2|
70857050|NCT02446743|141200509|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|Vaccine group difference|-32.0|||||TWO_SIDED|95.0|-46.5|-15.7|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-15.7|-46.5|
70857051|NCT02446743|141200509|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|Vaccine group difference|-28.0|||||TWO_SIDED|95.0|-38.4|-17.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-17.1|-38.4|
70857052|NCT02446743|141200509|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|Vaccine group difference|-6.0|||||TWO_SIDED|95.0|-19.2|9.2|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||9.2|-19.2|
70857053|NCT02446743|141200509|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|Vaccine group difference|-2.0|||||TWO_SIDED|95.0|-14.1|12.3|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||12.3|-14.1|
70857054|NCT02446743|141200509|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|Vaccine group difference|-5.0|||||TWO_SIDED|95.0|-13.6|5.6|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||5.6|-13.6|
71124873|NCT02227394|141755892|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|-0.02||||0.92|TWO_SIDED|90.0|-0.361|0.321|||t-test, 2 sided|||||0.321|-0.361|0.920
71124874|NCT02227394|141755893|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.08||||0.818|TWO_SIDED|90.0|-0.513|0.673|||t-test, 2 sided|||||0.673|-0.513|0.818
71124875|NCT02227394|141755894|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|11.4||||0.034|TWO_SIDED|90.0|2.789|20.011|||t-test, 2 sided|||||20.011|2.789|0.034
71087275|NCT03238417|141680960|SUPERIORITY|Difference-in-differences analysis using logistic regression. The number of activities were recoded into 0 vs 1+ activities. The model was adjusted for age, how often they saw women patients in the past year, location of practice in primary care or women's health clinic, and having had any type of quality improvement training. We also adjusted for non-response weights.|Odds Ratio (OR)|-0.48|STANDARD_ERROR_OF_MEAN|0.39||0.22|TWO_SIDED|95.0|-1.25|0.29||P-value is from the interaction term between EBQI and time, adjusted for non-response weights and characteristics described in the statistical analysis overview.|Regression, Logistic||The estimated value is predicted change in the odds of involving in one or more quality improvement activities, adjusting for characteristics described in the statistical analysis overview.|||0.29|-1.25|0.22
71087276|NCT03238417|141680961|NON_INFERIORITY|Analysis of Variance testing the differences in outcome between EBQI and control groups over 12 month period.|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|3.1||0.788|TWO_SIDED|95.0|-7.1|5.4||The p-value reflects the interaction term between EBQI and time|ANOVA|||||5.4|-7.1|0.788
71087277|NCT03238417|141680962|NON_INFERIORITY|Analysis of Variance testing for differences in outcomes between EBQI and control arms from baseline to 24 months.|Mean Difference (Net)|-1.5|STANDARD_ERROR_OF_MEAN|2.89||0.61|TWO_SIDED|95.0|-7.35|4.35||The p-value reflects the interaction terms between EBQI and control arms.|ANOVA|||||4.35|-7.35|0.61
71087278|NCT03238417|141680963|NON_INFERIORITY|ANOVA comparing changes in outcome over time between EBQI and control arms|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|10.5||0.987|TWO_SIDED|95.0|-21.45|21.11||The p-value reflects the interaction term between EBQI and time|ANOVA|||||21.11|-21.45|0.987
71087279|NCT03238417|141680964|NON_INFERIORITY|ANOVA comparing changes in outcome over time between EBQI and control groups|Mean Difference (Net)|-3.91|STANDARD_ERROR_OF_MEAN|10.35||0.708|TWO_SIDED|95.0|-24.89|17.08||The p-value reflects the interaction terms between EBQI and time|ANOVA|||||17.08|-24.89|0.708
71087280|NCT03238417|141680965|NON_INFERIORITY|ANOVA comparing changes in outcome over time between EBQI and control groups|Mean Difference (Net)|-4.51|STANDARD_ERROR_OF_MEAN|8.85||0.613|TWO_SIDED|95.0|-22.43|13.4||The p-value reflects the interaction term between EBQI and time|ANOVA|||||13.40|-22.43|0.613
71087281|NCT03238417|141680966|NON_INFERIORITY|ANOVA comparing changes in outcome over time between EBQI and control groups|Mean Difference (Net)|0.94|STANDARD_ERROR_OF_MEAN|9.48||0.922|TWO_SIDED|95.0|-18.26|20.13||The p-value reflects the interaction term between EBQI and time.|ANOVA|||||20.13|-18.26|0.922
71087282|NCT03238417|141680967|NON_INFERIORITY|two-way ANOVA testing change in a composite score of gender-neutral preventive care between EBQI and control arms over time|Mean Difference (Net)|0.58|STANDARD_ERROR_OF_MEAN|2.13||0.789|TWO_SIDED|95.0|-3.74|4.89||The p-value represents the interaction term between EBQI and control.|ANOVA|||||4.89|-3.74|0.789
71087283|NCT03238417|141680968|NON_INFERIORITY|ANOVA comparing changes in outcomes over time between EBQI and control groups|Mean Difference (Net)|-1.63|STANDARD_ERROR_OF_MEAN|2.45||0.51|TWO_SIDED|95.0|-6.6|3.33||The p-value reflects the interaction between EBQI and time.|ANOVA|The analysis is adjusted for EBQI and time.||||3.33|-6.60|0.51
71087284|NCT03238417|141680969|NON_INFERIORITY|ANOVA testing for change in outcome over time between EBQI and control arms|Mean Difference (Net)|3.11|STANDARD_ERROR_OF_MEAN|8.3||0.711|TWO_SIDED|95.0|-13.7|19.9||The p-value reflects the interaction between EBQI and time|ANOVA|||||19.9|-13.7|0.711
71087285|NCT03238417|141680970|NON_INFERIORITY|ANOVA comparing changes in outcome over time between EBQI and control arms|Mean Difference (Net)|8.49|STANDARD_ERROR_OF_MEAN|8.7||0.335|TWO_SIDED|95.0|-9.1|26.1||The p-value reflects the interaction term between EBQI and time.|ANOVA|||||26.1|-9.1|0.335
71087286|NCT03238417|141680971|NON_INFERIORITY|Analysis of Variance testing for change in outcome between EBQI and control groups from baseline to 12 months.|Mean Difference (Net)|-13.8|STANDARD_ERROR_OF_MEAN|12.3||0.268|TWO_SIDED|95.0|-38.7|11.1||P-value is from the interaction term between EBQI and time.|ANOVA|||||11.1|-38.7|0.268
71087287|NCT03238417|141680972|NON_INFERIORITY|Analysis of Variance testing the differences between EBQI and control from baseline and 24 months|Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|12.6||0.991|TWO_SIDED|95.0|-25.6|25.3||P-value is from the interaction between EBQI and time.|ANOVA|||||25.3|-25.6|0.991
71087288|NCT01239797|141680974|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0014|TWO_SIDED|95.0|0.6|0.89|||Log Rank|2-sided p-value for stratified log rank test||Hazard Ratio of Lenalidomide + Dexamethasone + Elotuzumab to Lenalidomide + Dexamethasone||0.89|0.60|0.0014
71087289|NCT01239797|141680975|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0005|TWO_SIDED|95.0|0.6|0.87|||Log Rank|2-sided p-value for stratified log rank test||Hazard Ratio of Lenalidomide + Dexamethasone + Elotuzumab to Lenalidomide + Dexamethasone||0.87|0.60|0.0005
71087290|NCT01239797|141680976|SUPERIORITY||Odds Ratio (OR)|1.95||||0.0002|TWO_SIDED|95.0|1.36|2.78|||Cochran-Mantel-Haenszel|Stratified by B2 microglobulin (\<3.5 mg/L vs \>=3.5 mg/L), number of prior lines of therapy (1 vs \>=2), and immunomodulatory drug use at randomization||Ratio of Lenalidomide + Dexamethasone + Elotuzumab to Lenalidomide + Dexamethasone||2.78|1.36|0.0002
71087291|NCT01239797|141680976|SUPERIORITY||Difference in ORR|12.7|||||TWO_SIDED|95.0|6.2|19.3||||||Difference of Lenalidomide + Dexamethasone + Elotuzumab minus Lenalidomide + Dexamethasone computed using the method of DerSimonian and Laird (weighted average over the strata)||19.3|6.2|
71087292|NCT02631941|141681017|EQUIVALENCE|For budesonide AUC0-last, the 90% Cls for Z7200 compared with Symbicort without and with charcoal lie entirely within the standard bioequivalence acceptance limits of (80% - 125.00%).|Adjusted geometric means ratio|100.64|||<|0.001|TWO_SIDED|90.0|95.82|105.69|||Mixed Models Analysis|||||105.69|95.82|<0.001
71087293|NCT02631941|141681017|EQUIVALENCE|For budesonide AUC0-last, the 90% Cls for Z7200 compared with Symbicort without and with charcoal lie entirely within the standard bioequivalence acceptance limits of (80% - 125.00%).|Adjusted geometric means ratio|102.11|||<|0.001|TWO_SIDED|90.0|95.55|109.13|||Mixed Models Analysis|||||109.13|95.55|<0.001
71087294|NCT02631941|141681018|EQUIVALENCE|For Formoterol AUC0-last, the 90% Cls for Z7200 compared to Symbicort without and with charcoal lie entirely within the standard bioequivalence acceptance limits of (80.00%, 125.00%).|Adjusted geometric means ratio|87.96||||0.002|TWO_SIDED|90.0|83.31|92.86|||Mixed Models Analysis|||||92.86|83.31|0.002
71087295|NCT02631941|141681018|EQUIVALENCE|For Formoterol AUC0-last, the 90% Cls for Z7200 compared to Symbicort without and with charcoal lie entirely within the standard bioequivalence acceptance limits of (80.00%, 125.00%).|Adjusted geometric means ratio|91.17||||0.005|TWO_SIDED|90.0|83.94|99.04|||Mixed Models Analysis|||||99.04|83.94|0.005
71087296|NCT02631941|141681019|EQUIVALENCE|For Budesonide Cmax, the 90% Cls for Z7200 compared with Symbicort without and with charcoal do not lie entirely within the wider bioequivalence acceptance limits of ( 73.74%, 135.62%) and standard bioequivalence acceptance limits of (80.00%, 125.00%), respectively.|Adjusted geometric means ratio|157.86||||1|TWO_SIDED|90.0|144.12|172.91|||Mixed Models Analysis|||||172.91|144.12|1.00
71087297|NCT02631941|141681019|EQUIVALENCE|For Budesonide Cmax, the 90% Cls for Z7200 compared with Symbicort without and with charcoal do not lie entirely within the wider bioequivalence acceptance limits of ( 73.74%, 135.62%) and standard bioequivalence acceptance limits of (80.00%, 125.00%), respectively.|Adjusted geometric means ratio|166.81||||1|TWO_SIDED|90.0|148.35|187.57|||Mixed Models Analysis|||||187.57|148.35|1.00
71087298|NCT02631941|141681020|EQUIVALENCE|For Formoterol Cmax, the 90% Cl for Z7200 compared to Symbicort without and with charcoal lie entirely within the wider bioequivalence acceptance limits of (77.65%, 128.79%) and standard bioequivalence acceptance limits of (80.00%, 125.00%), respectively.|Adjusted geometric means ratio|85.22||||0.012|TWO_SIDED|90.0|79.66|91.17|||Mixed Models Analysis|||||91.17|79.66|0.012
71087299|NCT02631941|141681020|EQUIVALENCE|For Formoterol Cmax, the 90% Cl for Z7200 compared to Symbicort without and with charcoal lie entirely within the wider bioequivalence acceptance limits of (77.65%, 128.79%) and standard bioequivalence acceptance limits of (80.00%, 125.00%), respectively.|Adjusted geometric means ratio|87.74||||0.02|TWO_SIDED|90.0|81.48|94.47|||Mixed Models Analysis|||||94.47|81.48|0.020
71087300|NCT02858401|141681036|OTHER|||||||0.1498|||||||Wilcoxon rank sum test|||||||0.1498
71087301|NCT02858401|141681036|OTHER|||||||0.064|||||||Wilcoxon rank sum test|||||||0.0640
71087302|NCT02858401|141681036|OTHER|||||||0.2807|||||||Wilcoxon rank sum test|||||||0.2807
71087303|NCT02858401|141681036|OTHER|||||||0.1228|||||||Wilcoxon rank sum test|||||||0.1228
71087304|NCT02858401|141681036|OTHER|||||||0.0289|||||||Wilcoxon rank sum test|||||||0.0289
71087305|NCT02858401|141681036|OTHER|||||||0.5895|||||||Wilcoxon rank sum test|||||||0.5895
71087306|NCT02858401|141681037|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087307|NCT02858401|141681037|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087308|NCT02858401|141681037|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087309|NCT02858401|141681038|OTHER|||||||0.5557|||||||Wilcoxon rank sum test|||||||0.5557
71087310|NCT02858401|141681038|OTHER|||||||0.5557|||||||Wilcoxon rank sum test|||||||0.5557
71087311|NCT02858401|141681038|OTHER|||||||0.8288|||||||Wilcoxon rank sum test|||||||0.8288
71087312|NCT02858401|141681038|OTHER|||||||0.5557|||||||Wilcoxon rank sum test|||||||0.5557
71087313|NCT02858401|141681038|OTHER|||||||0.6056|||||||Wilcoxon rank sum test|||||||0.6056
71087314|NCT02858401|141681038|OTHER|||||||0.5557|||||||Wilcoxon rank sum test|||||||0.5557
71087315|NCT02858401|141681039|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087316|NCT02858401|141681039|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087317|NCT02858401|141681039|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71087318|NCT02858401|141681040|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71124876|NCT02227394|141755895|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|5.6||||0.427|TWO_SIDED|90.0|-6.323|17.523|||t-test, 2 sided|||||17.523|-6.323|0.427
71124877|NCT03344172|141755899|SUPERIORITY||Odds Ratio (OR)|0.52||||0.63|TWO_SIDED|95.0|0.3|6.71|||Fisher Exact|||||6.71|0.30|0.63
71087319|NCT02858401|141681040|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087320|NCT02858401|141681040|OTHER|||||||0.1556|||||||Wilcoxon rank sum test|||||||0.1556
71087321|NCT02858401|141681040|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087322|NCT02858401|141681040|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087323|NCT02858401|141681040|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087324|NCT02858401|141681041|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087325|NCT02858401|141681041|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71124878|NCT03344172|141755900|SUPERIORITY||Mean Difference (Final Values)|-0.63|STANDARD_DEVIATION|0.52||0.13|TWO_SIDED|95.0|-1.0|-0.25|||t-test, 2 sided|||||-0.25|-1.00|0.13
71124879|NCT01177969|141755915|SUPERIORITY_OR_OTHER|||||||0.04||||||This analysis applies to the post-treatment assessment (16 weeks after baseline)|ANCOVA|||||||.04
71124880|NCT01177969|141755916|SUPERIORITY_OR_OTHER|||||||0.25||||||This analysis applies to the post-treatment assessment (16 weeks after baseline)|ANCOVA|||||||.25
71124881|NCT00869401|141756011|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79||||0.222|TWO_SIDED|95.0|0.54|1.16||Using Logrank Test|Log Rank|||||1.16|0.54|.222
71124882|NCT00869401|141756013|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.806||||0.183|TWO_SIDED|95.0|0.59|1.11|||Log Rank|||||1.11|0.59|0.183
71124883|NCT04405245|141756042|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.366||0.807|TWO_SIDED|95.0|-0.63|0.81|||ANCOVA|||||0.81|-0.63|0.8070
70945383|NCT03463577|141391204|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.4|||||TWO_SIDED|95.0|1.04|1.88|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of renal system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing.||1.88|1.04|
70945384|NCT03463577|141391204|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.5||||||95.0|1.21|1.86|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of musculoskeletal system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.86|1.21|
70945385|NCT03463577|141391204|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.13|||||TWO_SIDED|95.0|0.85|1.52|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of limb in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.52|0.85|
70945386|NCT03463577|141391204|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.98|||||TWO_SIDED|95.0|1.76|2.23|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of integument in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||2.23|1.76|
71087326|NCT02858401|141681041|OTHER|||||||0.3613|||||||Wilcoxon rank sum test|||||||0.3613
71087327|NCT02858401|141681042|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087328|NCT02858401|141681042|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087329|NCT02858401|141681042|OTHER|||||||0.1949|||||||Wilcoxon rank sum test|||||||0.1949
71087330|NCT02858401|141681042|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71124884|NCT04405245|141756042|SUPERIORITY||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.365||0.013|TWO_SIDED|95.0|-1.64|-0.2|||ANCOVA|||||-0.20|-1.64|0.0130
71124885|NCT02391961|141756051|SUPERIORITY|||||||0.842672|||||||ANOVA|||Statistical Analysis applies to the 4 subgroups: average PSR at baseline and after 3 hours on dalfampridine, and average PSR at baseline and after 3 hours on placebo.||||0.842672
71087331|NCT02858401|141681042|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087332|NCT02858401|141681042|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087333|NCT02858401|141681043|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087334|NCT02858401|141681043|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087335|NCT02858401|141681043|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087336|NCT02858401|141681044|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087337|NCT02858401|141681044|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087338|NCT02858401|141681044|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71087339|NCT02858401|141681045|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087340|NCT02858401|141681045|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087341|NCT02858401|141681045|OTHER|||||||0.1556|||||||Wilcoxon rank sum test|||||||0.1556
71087342|NCT02858401|141681045|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71124886|NCT02391961|141756052|SUPERIORITY|||||||0.972866|||||||ANOVA|||Statistical Analysis applies to the 4 subgroups: average PTD at baseline and after 3 hours on dalfampridine, and average PTD at baseline and after 3 hours on placebo.||||0.972866
71124887|NCT02391961|141756053|SUPERIORITY|||||||0.95|||||||ANOVA|||Statistical Analysis applies to the 4 subgroups: RA at baseline and after 3 hours on dalfampridine, and RA at baseline and after 3 hours on placebo.||||0.95
71124888|NCT02391961|141756054|SUPERIORITY|||||||0.9|||||||ANOVA|||Statistical Analysis applies to the 4 subgroups: MRS at baseline and after 3 hours on dalfampridine, and MRS at baseline and after 3 hours on placebo.||||0.9
71124889|NCT02391961|141756055|SUPERIORITY|||||||0.990995|||||||ANOVA|||Statistical Analysis applies to the 4 subgroups: 25 FWT at baseline and after 3 hours on dalfampridine, and 25 FWT at baseline and after 3 hours on placebo.||||0.990995
71124890|NCT02391961|141756056|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Statistical Analysis applies to the 2 groups, mean VFQ-25 scores on dalfampridine vs mean VFQ-25 scores on placebo||||0.71
70945387|NCT03463577|141391204|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.64|1.85|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for other and unspecified congenital anomalies in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.85|0.64|
70945388|NCT05694533|141391208|OTHER|Descriptive only.|Geometric Mean Ratio|0.84|||||TWO_SIDED|90.0|0.76|0.92||||A random effects model was used to calculate the confidence interval.|Day 15/Day 1|The comparison is between Midazolam on Day 15 and Midazolam on Day 1.||0.92|0.76|
70945389|NCT05694533|141391208|OTHER|Descriptive only.|Geometric Mean Ratio|0.8|||||TWO_SIDED|90.0|0.69|0.93||||A random effects model was used to calculate the confidence interval.|Day 15/Day 1|The comparison is between 1-hydroxymidazolam on Day 15 and 1-hydroxymidazolam on Day 1.||0.93|0.69|
70857055|NCT02446743|141200509|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|Vaccine group difference|12.0|||||TWO_SIDED|95.0|3.6|21.6|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||21.6|3.6|
70945390|NCT05694533|141391209|OTHER|Descriptive only.|Geometric Mean Ratio|0.85|||||TWO_SIDED|90.0|0.78|0.92||||A random effects model was used to calculate the confidence interval.|Day 15/Day 1|The comparison is between Midazolam on Day 15 and Midazolam on Day 1.||0.92|0.78|
70945391|NCT05694533|141391209|OTHER|Descriptive only.|Geometric Mean Ratio|0.81|||||TWO_SIDED|90.0|0.74|0.89||||A random effects model was used to calculate the confidence interval.|Day 15/Day 1|The comparison is between 1-hydroxymidazolam on Day 15 and 1-hydroxymidazolam on Day 1.||0.89|0.74|
70945392|NCT05694533|141391210|OTHER|Descriptive only.|Geometric Mean Ratio|0.85|||||TWO_SIDED|90.0|0.78|0.91||||A random effects model was used to calculate the confidence interval.|Day 15/Day 1|The comparison is between Midazolam on Day 15 and Midazolam on Day 1.||0.91|0.78|
70945393|NCT05694533|141391210|OTHER|Descriptive only.|Geometric Mean Ratio|0.87|||||TWO_SIDED|90.0|0.78|0.97||||A random effects model was used to calculate the confidence interval.|Day 15/Day 1|The comparison is between 1-hydroxymidazolam on Day 15 and 1-hydroxymidazolam on Day 1.||0.97|0.78|
70945394|NCT00594178|141391216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-250.8||||0.318|TWO_SIDED|95.0|-778.87|277.21|||t-test, 2 sided|||Paired samples T-test was used to assess the statisical changes between baseline and post-exercise lean muscle mass.||277.21|-778.87|.318
71087343|NCT02858401|141681045|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
70945395|NCT00594178|141391217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0645||||0.011|TWO_SIDED|95.0|0.01827|0.11073|||t-test, 2 sided|||Paired samples T-test was used to assess the statisical changes between baseline and post-exercise bone density.||.11073|.01827|.011
71087344|NCT02858401|141681045|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
70857056|NCT02446743|141200509|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|Vaccine group difference|15.0|||||TWO_SIDED|95.0|6.4|24.6|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||24.6|6.4|
70945396|NCT00496626|141391240|SUPERIORITY_OR_OTHER||GMT ratio|101.6|||<=|0.05|TWO_SIDED|95.0|88.1|117.2||The ANCOVA models showed the lower bounds of two-sided 95% CI on the GMT ratio \[GARDASIL™/placebo\] were greater than 1 for each HPV type, so the null hypothesis was rejected. The CI reported is for HPV18, the type with the smallest CI lower bound.|ANCOVA||Superiority of GARDASIL™ to placebo was claimed if, for each of the four HPV types, the lower bound of the two-sided 95% CI on the GMT ratio \[GARDASIL™/placebo\] being \>1, or equivalently, the two-sided p-value \<0.05.|An Analysis of Covariance (ANCOVA) model was used for each HPV type, based on the pooled data from all age groups and genders. The natural-log-transformed titer was the response variable, and vaccination group, gender and age group were covariates. The null hypothesis was that the GMT ratio (Gardasil/Placebo) was equal to 1.||117.2|88.1|<=0.05
70945397|NCT00496626|141391241|SUPERIORITY_OR_OTHER||Seroconversion Rate|96.65|||<=|0.05||95.0|93.74|98.46||The lower bound of the 95% CI for the seroconversion rate was greater than 90% for each type so the null hypothesis was rejected. The CI reported is for HPV6, the type with the smallest lower bound.|Exact Binomial CI|||The null hypothesis was that the seroconversion rate in the Gardasil® Group was less than 90% for each HPV type.||98.46|93.74|<=0.05
71087345|NCT02858401|141681046|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087346|NCT02858401|141681046|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087347|NCT02858401|141681046|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71087348|NCT02858401|141681047|OTHER|||||||0.1949|||||||Wilcoxon rank sum test|||||||0.1949
71087349|NCT02858401|141681047|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087350|NCT02858401|141681047|OTHER|||||||0.4278|||||||Wilcoxon rank sum test|||||||0.4278
71087351|NCT02858401|141681047|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
70857057|NCT02446743|141200509|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|Vaccine group difference|14.0|||||TWO_SIDED|95.0|7.6|20.3|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||20.3|7.6|
70857058|NCT02446743|141200510|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-44.0|||||TWO_SIDED|95.0|-52.7|-33.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-33.1|-52.7|
70857059|NCT02446743|141200510|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|-1.0|||||TWO_SIDED|95.0|-3.9|3.6|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||3.6|-3.9|
70857060|NCT02446743|141200510|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-2.7|2.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||2.4|-2.7|
71087352|NCT02858401|141681047|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087353|NCT02858401|141681047|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087354|NCT02858401|141681048|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
70945398|NCT00107978|141391247|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 10% was specified based on historical regulatory precedent.|Risk Difference (RD)|2.5||||||95.0|-2.9|7.9||p-values were not calculated in deference to confidence intervals.|2-sided 95% confidence interval|2-sided 95% confidence interval calculated on the difference in cure rates between treatment groups.||||7.9|-2.9|
70954321|NCT03843554|141411195|SUPERIORITY|Primary hypothesis. Null hypothesis is that the proportion of patients with a successful outcome of WHO OM severity grades 0-2 at the post study evaluation will not differ between the two randomized intervention groups. The estimated proportion of successes from our pilot trial is 0.30 with SOC. The alternative hypothesis is that the proportion of patients with a successful outcome differs between the two groups from the SOC proportion of 0.30 by +/-0.265 or more.||||||0.999|||||||Fisher Exact|OM WHO grading scale (less or equal to 2) severity employed a two-sided Fisher's exact test to compare the two arms at Visit 9.||||||0.999
71087355|NCT02858401|141681048|OTHER|||||||0.5716|||||||Wilcoxon rank sum test|||||||0.5716
71087356|NCT02858401|141681048|OTHER|||||||0.1869|||||||Wilcoxon rank sum test|||||||0.1869
71087357|NCT02858401|141681048|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
70945399|NCT02005393|141391254|NON_INFERIORITY_OR_EQUIVALENCE|Image settings were considered non-inferior if scores overlapped within 1 SD of mean.||||||||||||||||All 20 subjects enrolled in the study, including Subject 219 that was dropped from the Reader assessments due to corrupted images, were all rated as having similar white light images between the FICE and NBI procedures for each location used in the concurrence study. This assessment was intended to assure that no procedural sequence or visualization bias was introduced into the image acquisition process. The overall Reader mean (SD) for both FICE and NBI were equal to or greater than 3.0 (0.8).|The results reported utilized the average Likert scores for each of the 3 readers, for each of the FICE settings (0-9), as compared to FICE. The overall Reader mean (SD) for both FICE and NBI were equal to or greater than 3.0 (0.8).The overall mean scores were comparable between FICE and NBI to provide acceptable diagnostic image visualization quality.|||
70857061|NCT02446743|141200510|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-46.0|||||TWO_SIDED|95.0|-58.4|-29.8|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-29.8|-58.4|
70857062|NCT02446743|141200510|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|-3.0|||||TWO_SIDED|95.0|-7.7|5.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.1|-7.7|
70857063|NCT02446743|141200510|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|-1.0|||||TWO_SIDED|95.0|-5.7|3.7|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||3.7|-5.7|
70954322|NCT03843554|141411196|SUPERIORITY|OMDP-STANDARD|Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|174.6||0.6336|TWO_SIDED|95.0||||The above t-test p-value is for IL1a.|t-test, 2 sided|||The change in the inflammatory marker from baseline to the final intervention visit was analyzed using 95% confidence intervals and presented by treatment group. The two-sided t-test was used to compare the change in inflammatory markers between the two groups.||||0.6336
71087358|NCT02858401|141681048|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
71087359|NCT02858401|141681049|OTHER|||||||0.3613|||||||Wilcoxon rank sum test|||||||0.3613
71087360|NCT02858401|141681049|OTHER|||||||0.4237|||||||Wilcoxon rank sum test|||||||0.4237
71087361|NCT02858401|141681049|OTHER|||||||0.223|||||||Wilcoxon rank sum test|||||||0.2230
71087362|NCT02858401|141681050|OTHER|||||||0.3456|||||||Wilcoxon rank sum test|||||||0.3456
71087363|NCT02858401|141681050|OTHER|||||||0.3971|||||||Wilcoxon rank sum test|||||||0.3971
71087364|NCT02858401|141681050|OTHER|||||||0.1301|||||||Wilcoxon rank sum test|||||||0.1301
71087365|NCT02858401|141681050|OTHER|||||||0.3456|||||||Wilcoxon rank sum test|||||||0.3456
71087366|NCT02858401|141681050|OTHER|||||||0.3456|||||||Wilcoxon rank sum test|||||||0.3456
71087367|NCT02858401|141681050|OTHER|||||||0.3456|||||||Wilcoxon rank sum test|||||||0.3456
71087368|NCT02858401|141681051|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71087369|NCT02858401|141681051|OTHER|||||||0.4652|||||||Wilcoxon rank sum test|||||||0.4652
71087370|NCT02858401|141681051|OTHER|||||||0.5993|||||||Wilcoxon rank sum test|||||||0.5993
71087371|NCT02858401|141681052|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087372|NCT02858401|141681052|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087373|NCT02858401|141681052|OTHER|||||||0.1949|||||||Wilcoxon rank sum test|||||||0.1949
71087374|NCT02858401|141681052|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087375|NCT02858401|141681052|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087376|NCT02858401|141681052|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087377|NCT02858401|141681053|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087378|NCT02858401|141681053|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087379|NCT02858401|141681053|OTHER|||||||0.2763|||||||Wilcoxon rank sum test|||||||0.2763
71087380|NCT02858401|141681053|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087381|NCT02858401|141681053|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087382|NCT02858401|141681054|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
70857064|NCT02446743|141200510|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|Vaccine group difference|-40.0|||||TWO_SIDED|95.0|-51.8|-25.4|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-25.4|-51.8|
70857065|NCT02446743|141200510|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-3.3|9.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||9.0|-3.3|
70857066|NCT02446743|141200510|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-2.4|5.0|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.0|-2.4|
70857067|NCT02446743|141200510|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-4.0|||||TWO_SIDED|95.0|-12.4|5.8|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.8|-12.4|
70857068|NCT02446743|141200510|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.2|7.7|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||7.7|-2.2|
71087383|NCT02858401|141681054|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087384|NCT02858401|141681054|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
70857069|NCT02446743|141200510|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|6.0|||||TWO_SIDED|95.0|2.8|10.5|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||10.5|2.8|
70857070|NCT02446743|141200510|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-5.0|||||TWO_SIDED|95.0|-17.8|10.6|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||10.6|-17.8|
70857071|NCT02446743|141200510|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-3.2|13.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||13.0|-3.2|
70857072|NCT02446743|141200510|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|9.0|||||TWO_SIDED|95.0|3.7|16.5|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||16.5|3.7|
70857073|NCT02446743|141200510|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-2.0|||||TWO_SIDED|95.0|-11.8|11.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||11.0|-11.8|
70857074|NCT02446743|141200510|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-4.6|10.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||10.1|-4.6|
70857075|NCT02446743|141200510|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month days after booster or 2nd dose)|vaccine group difference|4.0|||||TWO_SIDED|95.0|-0.8|9.5|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||9.5|-0.8|
70945400|NCT02971228|141391298|OTHER|A paired t-test was used for the parametric method to compare patients receiving both treatments. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint. Thus, the 2 patients who withdrew from the trial after the Lilly Glucagon treatment before receiving ZP4207 were not included in the analysis.|Mean Difference (Final Values)|-6.9||||0.2518|TWO_SIDED|95.0|-19.63|5.84|||t-test, 2 sided||The estimated mean difference is based on the difference between the mean values for 10 patients in the ZP4207 group (12.78) and the matching 10 patients in the Lilly glucagon group (19.67)|A paired t-test or the Wilcoxon signed rank test for comparison of means with normally or non normally distributed residuals, respectively, was used. The Shapiro-Wilk test was used to determine the normality of the residuals for each comparison. The residuals were obtained from an analysis of variance (ANOVA) model with treatment group as the fixed effect. If the p-value of the test was \<0.001, the non-parametric method was utilized to analyze the endpoint parameter.||5.84|-19.63|0.2518
71087385|NCT02858401|141681055|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087386|NCT02858401|141681055|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087387|NCT02858401|141681055|OTHER|||||||0.1949|||||||Wilcoxon rank sum test|||||||0.1949
71124891|NCT02391961|141756057|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Statistical Analysis applies to the 2 groups, mean 10-item NOS scores on dalfampridine vs mean 10-item NOS scores on placebo||||0.95
71087388|NCT02858401|141681055|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087389|NCT02858401|141681055|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087390|NCT02858401|141681055|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087391|NCT02858401|141681056|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087392|NCT02858401|141681056|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087393|NCT02858401|141681056|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087394|NCT02858401|141681057|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
71087395|NCT02858401|141681057|OTHER|||||||0.5896|||||||Wilcoxon rank sum test|||||||0.5896
71087396|NCT02858401|141681057|OTHER|||||||0.8207|||||||Wilcoxon rank sum test|||||||0.8207
71087397|NCT02858401|141681057|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
71087398|NCT02858401|141681057|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
71087399|NCT02858401|141681057|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
71087400|NCT02858401|141681058|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087401|NCT02858401|141681058|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087402|NCT02858401|141681058|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087403|NCT02858401|141681059|OTHER|||||||0.3237|||||||Wilcoxon rank sum test|||||||0.3237
71087404|NCT02858401|141681059|OTHER|||||||0.3755|||||||Wilcoxon rank sum test|||||||0.3755
71087405|NCT02858401|141681059|OTHER|||||||0.4577|||||||Wilcoxon rank sum test|||||||0.4577
71087406|NCT02858401|141681059|OTHER|||||||0.3237|||||||Wilcoxon rank sum test|||||||0.3237
71087407|NCT02858401|141681059|OTHER|||||||0.3237|||||||Wilcoxon rank sum test|||||||0.3237
71124892|NCT02219503|141756068|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority of the Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir regimen in SVR12 to a historical threshold for sofosbuvir plus pegIFN/ ribavirin (RBV) for the treatment of participants with HCV Genotype 1b (GT1b) infection and cirrhosis was calculated using a 2-sided 95% CI from Wilson's score method. Non-inferiority was to be declared if the lower confidence bound was greater than 72.7%.|Percentage of Participants|100.0|||||TWO_SIDED|95.0|94.0|100.0|||||95% confidence interval (CI) was calculated using Wilson score method.|||100.0|94.0|
71124893|NCT02219503|141756068|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|100.0|||||TWO_SIDED|95.0|94.0|100.0|||||95% confidence interval (CI) was calculated using Wilson score method.|The superiority of the Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir regimen in SVR12 to a historical threshold for sofosbuvir plus pegIFN/ ribavirin (RBV) for the treatment of participants with HCV Genotype 1b (GT1b) infection and cirrhosis was calculated using a 2-sided 95% CI from Wilson's score method. Superiority was declared if the lower confidence bound was greater than 83.2%.||100.0|94.0|
71124894|NCT00343382|141756101|SUPERIORITY_OR_OTHER|||||||0.1675|||||||Kruskal-Wallis|||||||0.1675
71124895|NCT00343382|141756101|SUPERIORITY_OR_OTHER|||||||0.5974|||||||Kruskal-Wallis|||||||0.5974
71124896|NCT00343382|141756102|SUPERIORITY_OR_OTHER|||||||0.002|||||||Kruskal-Wallis|||Comparison of Rigors among arms.||||0.002
71124897|NCT00343382|141756102|SUPERIORITY_OR_OTHER|||||||0.006|||||||Kruskal-Wallis|||Comparison of Urinary Frequency among arms||||0.006
71124898|NCT00343382|141756102|SUPERIORITY_OR_OTHER|||||||0.03|||||||Kruskal-Wallis|||Comparison of nausea among arms||||0.030
71124899|NCT00343382|141756102|SUPERIORITY_OR_OTHER|||||||0.062|||||||Kruskal-Wallis|||Comparison of sweating among arms||||0.062
71124900|NCT01985360|141756130|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.79|1.29||||||||1.29|0.79|
71124901|NCT02914561|141756131|SUPERIORITY||Stratified Percentage Difference|12.7||||0.0017|TWO_SIDED|95.0|4.7|20.7|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel (CMH) test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \>=1).||20.7|4.7|0.0017
71124902|NCT02914561|141756131|SUPERIORITY||Stratified Percentage Difference|5.2||||0.173|TWO_SIDED|95.0|-2.4|12.7|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \>=1).||12.7|-2.4|0.1730
71124903|NCT02914561|141756131|SUPERIORITY||Stratified Percentage Difference|12.0||||0.0023|TWO_SIDED|95.0|4.1|19.9|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||19.9|4.1|0.0023
71124904|NCT02914561|141756131|SUPERIORITY||Stratified Percentage Difference|1.8||||0.6038|TWO_SIDED|95.0|-5.2|8.7|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||8.7|-5.2|0.6038
71087408|NCT02858401|141681059|OTHER|||||||0.3237|||||||Wilcoxon rank sum test|||||||0.3237
71087409|NCT02858401|141681060|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71087410|NCT02858401|141681060|OTHER|||||||0.4652|||||||Wilcoxon rank sum test|||||||0.4652
71087411|NCT02858401|141681060|OTHER|||||||0.7526|||||||Wilcoxon rank sum test|||||||0.7526
71087412|NCT02858401|141681061|OTHER|||||||0.5546|||||||Wilcoxon rank sum test|||||||0.5546
71087413|NCT02858401|141681061|OTHER|||||||0.6937|||||||Wilcoxon rank sum test|||||||0.6937
71087414|NCT02858401|141681061|OTHER|||||||0.8207|||||||Wilcoxon rank sum test|||||||0.8207
71087415|NCT02858401|141681061|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
71087416|NCT02858401|141681061|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
71087417|NCT02858401|141681061|OTHER|||||||0.7878|||||||Wilcoxon rank sum test|||||||0.7878
71087418|NCT02858401|141681062|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087419|NCT02858401|141681062|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087420|NCT02858401|141681062|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71124905|NCT02914561|141756132|SUPERIORITY||Stratified Percentage Difference|5.5||||0.1365|TWO_SIDED|95.0|-2.0|12.9|||Cochran-Mantel-Haenszel|CMH test stratified by use of corticosteroids (Yes/No), immunomodulators (Yes/No), and prior exposure to biologic agents (0, \>=1) at Day 1.||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \>=1).||12.9|-2.0|0.1365
71124906|NCT02914561|141756132|SUPERIORITY||Stratified Percentage Difference|2.4||||0.5103|TWO_SIDED|95.0|-4.8|9.5|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \>=1).||9.5|-4.8|0.5103
70954323|NCT03843554|141411196|SUPERIORITY|OMDP-STANDARD|Mean Difference (Final Values)|-17.1|STANDARD_ERROR_OF_MEAN|52.1||0.351|TWO_SIDED|95.0||||IL1b|t-test, 2 sided|||The change in the inflammatory marker from baseline to the final intervention visit was analyzed using 95% confidence intervals and presented by treatment group. The two-sided t- test was used to compare the change in inflammatory markers between the two groups.||||0.3510
70857076|NCT02446743|141200511|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-45.0|||||TWO_SIDED|95.0|-54.4|-34.3|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-34.3|-54.4|
70857077|NCT02446743|141200511|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|-1.0|||||TWO_SIDED|95.0|-4.5|5.2|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.2|-4.5|
70857078|NCT02446743|141200511|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-1.9|3.9|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||3.9|-1.9|
70857079|NCT02446743|141200511|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-48.0|||||TWO_SIDED|95.0|-60.8|-32.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-32.0|-60.8|
70857080|NCT02446743|141200511|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|-1.0|||||TWO_SIDED|95.0|-7.3|10.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||10.1|-7.3|
71087421|NCT02858401|141681063|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087422|NCT02858401|141681063|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087423|NCT02858401|141681063|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087424|NCT02858401|141681063|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
70945401|NCT02971228|141391298|OTHER||Median Difference (Final Values)|-8.02||||0.25|TWO_SIDED|95.0|-25.85|10.68|||Wilcoxon (Mann-Whitney)|||Non-parametric method p-value was from a Wilcoxon signed rank text. The normality of the residuals was assessed using the Shapiro-Wilk test, where the residuals were obtained from an ANOVA model with treatment group as the fixed effect. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint.||10.68|-25.85|0.2500
70945402|NCT02971228|141391299|OTHER|A paired t-test was used for the parametric method to compare patients receiving both treatments. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint. Thus, the 2 patients who withdrew from the trial after the Lilly Glucagon treatment before receiving ZP4207 were not included in the analysis.|Mean Difference (Final Values)|-0.28||||0.8508|TWO_SIDED|95.0|-3.55|2.99|||t-test, 2 sided|||A paired t-test or the Wilcoxon signed rank test for comparison of means with normally or non normally distributed residuals, respectively, was used. The Shapiro-Wilk test was used to determine the normality of the residuals for each comparison. The residuals were obtained from an analysis of variance (ANOVA) model with treatment group as the fixed effect. If the p-value of the test was \<0.001, the non-parametric method was utilized to analyze the endpoint parameter.||2.99|-3.55|0.8508
70945403|NCT02971228|141391299|OTHER||Median Difference (Final Values)|0.03|||>|0.9999|TWO_SIDED|95.0|-4.12|3.13|||Wilcoxon (Mann-Whitney)|||Non-parametric method p-value was from a Wilcoxon signed rank text. The normality of the residuals was assessed using the Shapiro-Wilk test, where the residuals were obtained from an ANOVA model with treatment group as the fixed effect. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint.||3.13|-4.12|>0.9999
70945404|NCT02971228|141391300|OTHER|A paired t-test was used for the parametric method to compare patients receiving both treatments. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint. Thus, the 2 patients who withdrew from the trial after the Lilly Glucagon treatment before receiving ZP4207 were not included in the analysis.|Mean Difference (Final Values)|0.63||||0.1847|TWO_SIDED|95.0|-0.36|1.62|||t-test, 2 sided|||A paired t-test or the Wilcoxon signed rank test for comparison of means with normally or non normally distributed residuals, respectively, was used. The Shapiro-Wilk test was used to determine the normality of the residuals for each comparison. The residuals were obtained from an analysis of variance (ANOVA) model with treatment group as the fixed effect. If the p-value of the test was \<0.001, the non-parametric method was utilized to analyze the endpoint parameter.||1.62|-0.36|0.1847
70945405|NCT02971228|141391300|OTHER||Median Difference (Final Values)|0.02||||0.0781|TWO_SIDED|95.0|-0.01|3.09|||Wilcoxon (Mann-Whitney)|||Non-parametric method p-value was from a Wilcoxon signed rank text. The normality of the residuals was assessed using the Shapiro-Wilk test, where the residuals were obtained from an ANOVA model with treatment group as the fixed effect. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint.||3.09|-0.01|0.0781
70945406|NCT01664923|141391314|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.181|0.32||P-value based on log-rank test stratified by disease stage at study entry as reported on the case report form (CRF).|Log Rank||Hazard ratio is based on a Cox regression model (with treatment as the only covariate) stratified by disease stage at study entry and is relative to bicalutamide with \< 1 favoring enzalutamide.|||0.320|0.181|<0.0001
70945407|NCT01664923|141391315|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.19|||<|0.0001|TWO_SIDED|95.0|0.137|0.264||P-value based on log-rank test stratified by disease stage at study entry as reported on the CRF.|Log Rank||Hazard ratio is based on a Cox regression model (with treatment as the only covariate) stratified by disease stage at study entry and is relative to bicalutamide with \< 1 favoring enzalutamide.|||0.264|0.137|<0.0001
70945408|NCT01664923|141391316|SUPERIORITY_OR_OTHER||Difference in rates|50.0|||<|0.0001|TWO_SIDED|95.0|41.4|58.5|||Cochran-Mantel-Haenszel|Comparison of the 2 treatment groups using the Cochran-Mantel-Haenszel mean score test stratified by disease stage at study entry.|Enzalutamide response rate minus bicalutamide response rate.|||58.5|41.4|<0.0001
70945409|NCT01664923|141391317|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.324|||<|0.0001|TWO_SIDED|95.0|0.211|0.497|||Log Rank|P-value is based on an unstratified log-rank test.|Hazard ratio is based on an unstratified Cox-regression model (with treatment as the only covariate) and is relative to bicalutamide with \< 1 favoring enzalutamide.|||0.497|0.211|<0.0001
70945410|NCT01664923|141391318|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.4945|TWO_SIDED|95.0|0.695|1.192||This secondary endpoint was not adjusted for multiple comparisons.|Log Rank|P-value is based on a log-rank test stratified by disease stage at study entry.|Hazard ratio is based on a Cox regression model (with treatment as the only covariate) stratified by disease stage at study entry and is relative to bicalutamide with \< 1 favoring enzalutamide.|||1.192|0.695|0.4945
70945411|NCT01664923|141391319|SUPERIORITY_OR_OTHER||Difference in objective response rate|46.05|||<|0.0001|TWO_SIDED|95.0|26.79|65.3||This secondary endpoint was not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Based on unstratified Cochran-Mantel-Haenszel mean score test.||||65.30|26.79|<0.0001
70945412|NCT01013740|141391468|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||||95.0|0.53|1.35|||||The Pike estimator of the treatment HR was based on the log rank test.|||1.35|0.53|
70945413|NCT01013740|141391473|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|0.63|3.58||||||||3.58|0.63|
70945414|NCT00338949|141391477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.228|||||||t-test, 2 sided|||||||0.228
70945415|NCT00338949|141391478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.958|||||||t-test, 2 sided|||||||0.958
70945416|NCT00582114|141391485|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.36||||0.001|TWO_SIDED|95.0|1.36|4.23|||Mixed Models Analysis|||Cardiovascular events were counted by subject and included the following: myocardial infarction, stroke, hospitalization for congestive heart failure, hospitalized angina, arrhythmias, cardiac arrest, coronary revascularization and heart valve replacement. The duration of participation in the study per subject, which according to the trial design could be up to 12 months, was determined. Incidence rate ratio (IRR) by treatment was then determined along with the 95%confidence intervals (95% CIs).||4.23|1.36|0.001
70945417|NCT00582114|141391485|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.29||||0.02|TWO_SIDED|95.0|1.07|5.21|||Mixed Models Analysis|||As a post hoc analysis, we determined the narrower definition of cardiovascular events per group that included myocardial infarction, stroke, congestive heart failure or cardiovascular death. The duration of participation in the study per subject, which according to the trial design could be up to 12 months, was determined. Incidence rate ratio (IRR) by treatment was then determined along with the 95%confidence intervals (95% CIs).||5.21|1.07|0.02
70945418|NCT00582114|141391485|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.13||||0.02|TWO_SIDED|95.0|1.08|10.99|||Mixed Models Analysis|||Hospitalization for congestive heart failure between groups was analyzed. The duration of participation in the study per subject, which according to the trial design could be up to 12 months, was determined. Incidence rate ratio (IRR) by treatment was then determined along with the 95%confidence intervals.||10.99|1.08|0.02
70945419|NCT00582114|141391485|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.61||||0.002|TWO_SIDED|95.0|1.18|2.19|||Mixed Models Analysis|||All-cause hospitalizations between groups were analyzed. The duration of participation in the study per subject, which according to the trial design could be up to 12 months, was determined. Incidence rate ratio (IRR) by treatment was then determined along with the 95%confidence intervals.||2.19|1.18|0.002
70945420|NCT02604342|141391486|SUPERIORITY||Hazard Ratio (HR)|0.2|||<|0.001|TWO_SIDED|95.0|0.12|0.33|||Stratified log-rank test||Estimated hazard ratio obtained from stratified Cox model with treatment group as covariate.|||0.33|0.12|<0.001
70945421|NCT02604342|141391487|SUPERIORITY||Difference in C-ORR|0.667|||<|0.001|TWO_SIDED|95.0|0.39|0.86|||Chi-squared|||95% confidence interval of the difference (alectinib - chemotherapy) computed using Hauck-Anderson approach.||0.86|0.39|<0.001
70945422|NCT00130728|141391510|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.7583||95.0|0.799|1.177||relative to placebo arm|Log Rank||Stratified analysis; Hazard ratio is relative to placebo arm.|||1.177|0.799|0.7583
70945423|NCT00130728|141391511|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.623|||<|0.0001||95.0|0.519|0.748||relative to placebo arm|Log Rank||Stratified analysis; hazard ratio is relative to placebo arm.|||0.748|0.519|<.0001
70945424|NCT00130728|141391512|SUPERIORITY_OR_OTHER_LEGACY||Percentage difference|6.4||||0.0068||95.0|1.8|11.3||Relative to placebo arm|Mantel Haenszel||Difference in objective response rates relative to placebo arm|||11.3|1.8|0.0068
70945425|NCT03181282|141391529|SUPERIORITY||Slope|0.0529|STANDARD_ERROR_OF_MEAN|0.0194||0.0194|TWO_SIDED|95.0|0.0132|0.0925|||Mixed Models Analysis|Mixed model analysis with repeated measures.||This analysis is for the On Medication / On Stimulation condition. Age was controlled for in the analysis given the baseline difference in age between groups.||0.0925|0.0132|0.0194
71087425|NCT02858401|141681063|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0000
71087426|NCT02858401|141681063|OTHER|||||||0.1949|||||||Wilcoxon rank sum test|||||||0.1949
70945426|NCT03181282|141391529|SUPERIORITY||Slope|0.0718|STANDARD_ERROR_OF_MEAN|0.0231||0.004625|TWO_SIDED|95.0|0.0242|0.1194|||Mixed Models Analysis|Mixed models analysis with repeated measures.||This analysis is for the Off Medication / Off Stimulation Condition. Age was controlled for in the analysis given the baseline difference in age between groups.||0.1194|0.0242|0.004625
70945427|NCT03181282|141391530|SUPERIORITY||Slope|10.5248|STANDARD_ERROR_OF_MEAN|4.8439||0.038389|TWO_SIDED|95.0|0.6038|20.4459|||Mixed Models Analysis|Mixed models analysis with repeated measures.||This analysis is for the On Medication / On Stimulation condition. Age was controlled for in the analysis given the baseline difference in age between groups.||20.4459|0.6038|0.038389
71087427|NCT02858401|141681064|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
70945428|NCT03181282|141391530|SUPERIORITY||Slope|7.7233|STANDARD_ERROR_OF_MEAN|4.668||0.109873|TWO_SIDED|95.0|-1.8652|17.3117|||Mixed Models Analysis|Mixed models analysis with repeated measures.||This analysis is for the Off Medication / Off Stimulation condition. Age was controlled for in the analysis given the baseline difference in age between groups.||17.3117|-1.8652|0.109873
71087428|NCT02858401|141681064|OTHER|||||||0.5716|||||||Wilcoxon rank sum test|||||||0.5716
70954324|NCT03843554|141411196|SUPERIORITY|OMDP-STANDARD|Mean Difference (Final Values)|-102.2|STANDARD_ERROR_OF_MEAN|252.8||0.351|TWO_SIDED|95.0||||IL2|t-test, 2 sided|||The change in the inflammatory marker from baseline to the final intervention visit was analyzed using 95% confidence intervals and presented by treatment group. The two-sided t- test was used to compare the change in inflammatory markers between the two groups.||||0.3510
71087429|NCT02858401|141681064|OTHER|||||||0.6908|||||||Wilcoxon rank sum test|||||||0.6908
71087430|NCT02858401|141681064|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
71087431|NCT02858401|141681064|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
71087432|NCT02858401|141681065|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087433|NCT02858401|141681065|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087434|NCT02858401|141681065|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71087435|NCT02858401|141681066|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
71087436|NCT02858401|141681066|OTHER|||||||0.5896|||||||Wilcoxon rank sum test|||||||0.5896
71087437|NCT02858401|141681066|OTHER|||||||0.1784|||||||Wilcoxon rank sum test|||||||0.1784
71087438|NCT02858401|141681066|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
71087439|NCT02858401|141681066|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
71087440|NCT02858401|141681066|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
71087441|NCT02858401|141681067|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087442|NCT02858401|141681067|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087443|NCT02858401|141681067|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087444|NCT02858401|141681068|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71087445|NCT02858401|141681068|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71087446|NCT02858401|141681068|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
70945429|NCT02484547|141391550|SUPERIORITY||Difference|-0.26||||0.0901|TWO_SIDED|95.0|-0.569|0.041|||MMRM|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in CDR-SB as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline CDR-SB, baseline CDR-SB by visit interaction, baseline MMSE, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||0.041|-0.569|0.0901
70945430|NCT02484547|141391550|SUPERIORITY||Difference|-0.39||||0.012|TWO_SIDED|95.0|-0.694|-0.086|||MMRM|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in CDR-SB as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline CDR-SB, baseline CDR-SB by visit.||-0.086|-0.694|0.0120
70945431|NCT02484547|141391551|SUPERIORITY||Difference|-0.1||||0.7578|TWO_SIDED|95.0|-0.65|0.48|||MMRM|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference from Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MMSE as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline MMSE, baseline MMSE by visit interaction, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||0.48|-0.65|0.7578
70945432|NCT02484547|141391551|SUPERIORITY||Difference|0.6||||0.0493|TWO_SIDED|95.0|0.0|1.13|||MMRM|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference from Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MMSE as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline MMSE, baseline MMSE by visit interaction, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||1.13|0.00|0.0493
70945433|NCT02484547|141391552|SUPERIORITY||Difference|-0.701||||0.1962|TWO_SIDED|95.0|-1.7649|0.3627|||MMRM|||Adjusted mean for each treatment group(Placebo,BIIB037 Low Dose,BIIB037 High Dose),difference from Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in ADASCog 13 as dependent variable and with fixed effects of treatment group,categorical visit,treatment-by-visit interaction,baseline ADAS-Cog 13,baseline ADAS-Cog 13 by visit interaction,baseline MMSE,AD symptomatic medication use at baseline,region, and laboratory ApoE status.||0.3627|-1.7649|0.1962
70945434|NCT02484547|141391552|SUPERIORITY||Difference|-1.4||||0.0097|TWO_SIDED|95.0|-2.4596|-0.3396|||MMRM|||Adjusted mean for each treatment group(Placebo,BIIB037 Low Dose,BIIB037 High Dose),difference from Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in ADASCog 13 as dependent variable and with fixed effects of treatment group,categorical visit,treatment-by-visit interaction,baseline ADAS-Cog 13,baseline ADAS-Cog 13 by visit interaction,baseline MMSE,AD symptomatic medication use at baseline,region, and laboratory ApoE status.||-0.3396|-2.4596|0.0097
70945435|NCT02484547|141391553|SUPERIORITY||Difference|0.7||||0.1515|TWO_SIDED|95.0|-0.27|1.73|||MMRM|||Adjusted mean for each treatment group (Placebo, BIIB037 Low dose and BIIB037 High Dose), difference from Placebo,95% CI and p-value at each time point were based on an MMRM model, with change from baseline in ADCSADL-MCI as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline ADCS-ADL-MCI, baseline ADCS-ADL-MCI by visit interaction, baseline MMSE, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||1.73|-0.27|0.1515
70945436|NCT02484547|141391553|SUPERIORITY||Difference|1.7||||0.0006|TWO_SIDED|95.0|0.75|2.74|||MMRM|||Adjusted mean for each treatment group (Placebo, BIIB037 Low dose and BIIB037 High Dose), difference from Placebo,95% CI and p-value at each time point were based on an MMRM model, with change from baseline in ADCSADL-MCI as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline ADCS-ADL-MCI, baseline ADCS-ADL-MCI by visit interaction, baseline MMSE, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||2.74|0.75|0.0006
70945437|NCT04088136|141391627|EQUIVALENCE|A one-tailed independent samples t-test was conducted. A p-value of .05 was used to determine statistical significance.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.17||0.67|TWO_SIDED|95.0|-0.42|0.55|||t-test, 2 sided|Use of pooled error term, df = 60.|Negative number reflects fewer errors in EMMI group, as predicted.|||0.55|-0.42|.67
71087447|NCT02858401|141681069|OTHER|||||||0.3074|||||||Wilcoxon rank sum test|||||||0.3074
71087448|NCT02858401|141681069|OTHER|||||||0.3074|||||||Wilcoxon rank sum test|||||||0.3074
71087449|NCT02858401|141681070|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71087450|NCT02858401|141681070|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
70857081|NCT02446743|141200511|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|-1.0|||||TWO_SIDED|95.0|-5.7|3.7|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||3.7|-5.7|
71087451|NCT02858401|141681070|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71087452|NCT02858401|141681071|OTHER|||||||0.1757|||||||Wilcoxon rank sum test|||||||0.1757
70945438|NCT04088136|141391628|SUPERIORITY|Everyday Metacognitive Memory group predicted to have superior scores to Memory Strategy Control|Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.28|<|0.47|TWO_SIDED||||||t-test, 1 sided||pooled error term, equal variance assumption, df = 60|||||<.47
70945439|NCT04088136|141391629|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|2.0|<|0.13|TWO_SIDED|95.0|-3.7|7.6|||t-test, 1 sided|||||7.6|-3.7|< .13
70945440|NCT04088136|141391630|EQUIVALENCE|Directional hypothesis of fewer errors in Everyday Metacognitive Memory group|Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|1.8||0.57|TWO_SIDED|95.0|-4.8|2.6||A p-value of .05 was used to determine statistical significance.|t-test, 2 sided|Pooled error term, df = 51||||2.6|-4.8|.57
70945441|NCT04088136|141391631|EQUIVALENCE|Two-tailed test of hypothesis of fewer errors in EMMI group|Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|2.3||0.72|TWO_SIDED|95.0|-3.8|5.5||A p-value of .05 was used to determine statistical significance|t-test, 2 sided|Pooled error term, df = 49||||5.5|-3.8|.72
70945442|NCT04088136|141391632|OTHER|Test of Group X Time interaction|||||<|0.69|||||||Mixed Models Analysis|pooled df = 59||"We ran a 2 X 2 (Group X Time) mixed model analysis with repeated measures on Time (pretest, posttest).~Hypothesis was that Memory Strategy Control group would show greater improvements from pretest to posttest in recall scores"||||< .69
70945443|NCT04088136|141391633|OTHER|One-tailed test of Group X Time interaction|||||<|0.037|||||||Mixed Models Analysis|||"We ran a 2 X 2 (Group X Time) mixed effect model with repeated measures on Time (pretest-posttest).~Predicted hypothesis was greater pretest-posttest improvement in the Memory Strategy Contol group"||||< .037
70945444|NCT04088136|141391634|OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|9.9||0.69|TWO_SIDED|95.0|-4.0|8.4|||t-test, 2 sided||one instance of missing data due to computer failure during testing. Pooled error term resulting in df = 59|||8.4|-4.0|.69
70945445|NCT04088136|141391635|EQUIVALENCE|Directional hypothesis of shorter time in Everyday Metacognitive Memory group|Mean Difference (Final Values)|-50.0|STANDARD_ERROR_OF_MEAN|103.3||0.63|TWO_SIDED|95.0|-257.4|157.4||A p-value of .05 was used to determine statistical significance|t-test, 2 sided|Use of pooled error term, DF = 51||||157.4|-257.4|.63
70945446|NCT04088136|141391636|EQUIVALENCE|Two-tailed test of hypothesis of shorter time in Everyday Metacognitive Memory group|Mean Difference (Final Values)|10.6|STANDARD_ERROR_OF_MEAN|43.8||0.81|TWO_SIDED|95.0|-77.4|98.5||A p-value of .05 was used to determine statistical significance|t-test, 2 sided|Use of pooled error term, df = 49||||98.5|-77.4|.81
70945447|NCT04088136|141391637|OTHER||||||<|0.14|||||||Mixed Models Analysis|mixed procedure with unrestricted error covariance matrix. Pooled df for MSWithin = 60||We conducted a 2 X 2 (Group X Time) mixed effects model with repeated measures on Time (pretest, posttest). Hypothesis was greater reduction in memory complaints from pretest to posttest in EMMI group||||< .14
70945448|NCT04088136|141391638|OTHER|||||||0.037|||||||Mixed Models Analysis|||We ran a 2 X 2 (Group X Time) mixed effect model with repeated measures on Time (pretest-posttest)||||.037
70945449|NCT04088136|141391639|OTHER|Hypothesis was greater increase in memory self-efficacy for Everyday Metacognitive Memory group|||||<|0.33|||||||Mixed Models Analysis|mixed model specified unrestricted residual (error) covariance matrix. Pooled df in MS Error = 60||We ran a 2 X 2 (Group X Time) mixed effects model with repeated measures on Time (pretest, posttest).||||< .33
70945450|NCT04088136|141391640|OTHER||||||<|0.2|||||||Mixed Models Analysis|||We ran a 2 X 2 (Group X Time) mixed effects model with repeated measures on Time (pretest, posttest). Hypothesis was greater increase in memory control in EMMI group||||< .20
70945451|NCT04088136|141391641|OTHER|Hypothesis was greater increase in use of external mnemonics in EMMI group|||||<|0.2|||||||Mixed Models Analysis|||||||< .20
70945452|NCT00143598|141391677|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.58|TWO_SIDED|95.0|0.73|1.76|||Regression, Cox|Adjusted for centre||||1.76|.73|.58
70945453|NCT01878383|141391701|OTHER|Sensitivity is the percent of non-pregnant women positive for shedding HSV by culture method in which GeneXpert test results is positive. Units equals percent non-pregnant women positive.|Sensitivity|100.0|||||TWO_SIDED|95.0|90.8|100.0|||||95% Clopper-Pearson Exact Confidence Interval|||100|90.8|
70945454|NCT01878383|141391702|OTHER|Positive percent agreement is the percent of pregnant women with positive routine PCR results in which GeneXpert test results is positive. Units equal percent of pregnant women positive.|Positive percent agreement|80.0|||||TWO_SIDED|95.0|73.7|86.3|||||95% large sample confidence interval|||86.3|73.7|
70945455|NCT01878383|141391703|OTHER|Negative percent agreement is the percent of pregnant women with negative routine PCR results in which GeneXpert test results is negative. Units equal percent of pregnant women negative.|Negative percent agreement|99.2|||||TWO_SIDED|95.0|99.0|99.5|||||95% large sample confidence interval|||99.5|99|
70945456|NCT04260464|141391712|OTHER||Test/Reference Ratio|110.15|||||TWO_SIDED|95.0|83.76|144.86||||||Analysis of variance (ANOVA) was used to compare the natural log transformed Cmax for PF-06700841 between the normal renal function group (Reference) and the severe impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||144.86|83.76|
71087453|NCT02858401|141681071|OTHER|||||||0.1757|||||||Wilcoxon rank sum test|||||||0.1757
71087454|NCT02858401|141681071|OTHER|||||||0.5993|||||||Wilcoxon rank sum test|||||||0.5993
71087455|NCT02858401|141681072|OTHER|||||||0.8504|||||||Wilcoxon rank sum test|||||||0.8504
71087456|NCT02858401|141681072|OTHER|||||||0.5716|||||||Wilcoxon rank sum test|||||||0.5716
71087457|NCT02858401|141681072|OTHER|||||||0.6908|||||||Wilcoxon rank sum test|||||||0.6908
71087458|NCT02858401|141681072|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
71087459|NCT02858401|141681072|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
71087460|NCT02858401|141681073|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71087461|NCT02858401|141681073|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71087462|NCT02858401|141681073|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71087463|NCT02858401|141681074|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71087464|NCT02858401|141681074|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71087465|NCT02858401|141681074|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71087466|NCT02858401|141681075|OTHER|||||||0.3074|||||||Wilcoxon rank sum test|||||||0.3074
71087467|NCT02858401|141681075|OTHER|||||||0.3074|||||||Wilcoxon rank sum test|||||||0.3074
71087468|NCT02858401|141681076|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087469|NCT02858401|141681076|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71087470|NCT02858401|141681076|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71087471|NCT02858401|141681077|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087472|NCT02858401|141681077|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087473|NCT02858401|141681077|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71087474|NCT02858401|141681078|OTHER|||||||0.1757|||||||Wilcoxon rank sum test|||||||0.1757
71124907|NCT02914561|141756132|SUPERIORITY||Stratified Percentage Difference|0.1||||0.9797|TWO_SIDED|95.0|-6.5|6.6|||Cochran-Mantel-Haenszel|CMH test stratified by use of corticosteroids (Yes/No), immunomodulators (Yes/No), and prior exposure to biologic agents (\<=1, \>1) at Day 1.||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||6.6|-6.5|0.9797
71124908|NCT02914561|141756132|SUPERIORITY||Stratified Percentage Difference|2.4||||0.4264|TWO_SIDED|95.0|-3.9|8.8|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||8.8|-3.9|0.4264
71124909|NCT02914561|141756133|SUPERIORITY||Stratified Percentage Difference|13.7||||0.0839|TWO_SIDED|95.0|-1.0|28.4|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||28.4|-1.0|0.0839
71124910|NCT02914561|141756133|SUPERIORITY||Stratified Percentage Difference|1.5||||0.8288|TWO_SIDED|95.0|-12.1|15.0|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||15.0|-12.1|0.8288
71124911|NCT02914561|141756134|SUPERIORITY||Stratified Percentage Difference|20.6||||0.0038|TWO_SIDED|95.0|8.2|33.1|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||33.1|8.2|0.0038
71124912|NCT02914561|141756134|SUPERIORITY||Stratified Percentage Difference|5.8||||0.3466|TWO_SIDED|95.0|-6.6|18.3|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||18.3|-6.6|0.3466
71124913|NCT02914561|141756135|SUPERIORITY||Stratified Percentage Difference|6.9||||0.0963|TWO_SIDED|95.0|-1.4|15.2|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \>=1).||15.2|-1.4|0.0963
71124914|NCT02914561|141756135|SUPERIORITY||Stratified Percentage Difference|4.2||||0.305|TWO_SIDED|95.0|-3.9|12.2|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \>=1).||12.2|-3.9|0.3050
71124915|NCT02914561|141756135|SUPERIORITY||Stratified Percentage Difference|11.9||||0.0039|TWO_SIDED|95.0|3.7|20.2|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||20.2|3.7|0.0039
71087475|NCT02858401|141681078|OTHER|||||||0.1757|||||||Wilcoxon rank sum test|||||||0.1757
71087476|NCT02858401|141681078|OTHER|||||||0.223|||||||Wilcoxon rank sum test|||||||0.2230
71087477|NCT02858401|141681079|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71087478|NCT02858401|141681079|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71087479|NCT02858401|141681079|OTHER|||||||0.4652|||||||Wilcoxon rank sum test|||||||0.4652
71087480|NCT02858401|141681080|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71087481|NCT02858401|141681080|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71087482|NCT02858401|141681080|OTHER|||||||0.4652|||||||Wilcoxon rank sum test|||||||0.4652
71087483|NCT02858401|141681081|OTHER|||||||0.1757|||||||Wilcoxon rank sum test|||||||0.1757
71087484|NCT02858401|141681081|OTHER|||||||0.1757|||||||Wilcoxon rank sum test|||||||0.1757
71087485|NCT02858401|141681081|OTHER|||||||0.223|||||||Wilcoxon rank sum test|||||||0.2230
71087486|NCT02858401|141681084|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71087487|NCT02858401|141681084|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71087488|NCT02858401|141681084|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71087489|NCT02858401|141681084|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71087490|NCT02858401|141681084|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71087491|NCT02858401|141681084|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71087492|NCT02858401|141681085|OTHER|||||||0.3333|||||||Fisher Exact|||||||0.3333
71087493|NCT02858401|141681086|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71087494|NCT02858401|141681086|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71087495|NCT02858401|141681086|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71087496|NCT02858401|141681086|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71087497|NCT02858401|141681086|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71087498|NCT02858401|141681086|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71087499|NCT02858401|141681087|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71087500|NCT02858401|141681087|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71087501|NCT02858401|141681087|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71087502|NCT02858401|141681087|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71087503|NCT02858401|141681087|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71124916|NCT02914561|141756135|SUPERIORITY||Stratified Percentage Difference|1.1||||0.7556|TWO_SIDED|95.0|-6.2|8.5|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||8.5|-6.2|0.7556
70857082|NCT02446743|141200511|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-41.0|||||TWO_SIDED|95.0|-53.3|-25.5|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-25.5|-53.3|
70857083|NCT02446743|141200511|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-4.8|8.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.1|-4.8|
70945457|NCT04260464|141391712|OTHER||Test/Reference Ratio|94.58|||||TWO_SIDED|90.0|55.84|160.19||||||ANOVA was used to compare the natural log transformed Cmax for PF-06700841 between the normal renal function group (Reference) and the mild impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||160.19|55.84|
70945458|NCT04260464|141391712|OTHER||Test/Reference Ratio|124.2|||||TWO_SIDED|90.0|100.24|153.89||||||ANOVA was used to compare the natural log transformed Cmax for PF-06700841 between the normal renal function group (Reference) and the moderate impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||153.89|100.24|
70945459|NCT04260464|141391713|OTHER||Test/Reference Ratio|112.08|||||TWO_SIDED|95.0|60.85|206.45||||||ANOVA was used to compare the natural log transformed AUCinf for PF-06700841 between normal renal function group (Reference) and the severe impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||206.45|60.85|
70945460|NCT04260464|141391713|OTHER||Test/Reference Ratio|70.97|||||TWO_SIDED|90.0|27.6|182.49||||||ANOVA was used to compare the natural log transformed AUCinf for PF-06700841 between normal renal function group (Reference) and the mild impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||182.49|27.60|
70945461|NCT04260464|141391713|OTHER||Test/Reference Ratio|147.7|||||TWO_SIDED|90.0|75.17|290.21||||||ANOVA was used to compare the natural log transformed AUCinf for PF-06700841 between normal renal function group (Reference) and the moderate impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||290.21|75.17|
70945462|NCT04260464|141391714|OTHER||Test/Reference Ratio|177.53|||||TWO_SIDED|95.0|135.82|232.04||||||ANOVA was used to compare the natural log transformed Cmax for M1 between normal renal function group (Reference) and the severe impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||232.04|135.82|
70945463|NCT04260464|141391714|OTHER||Test/Reference Ratio|132.69|||||TWO_SIDED|90.0|95.08|185.17||||||ANOVA was used to compare the natural log transformed Cmax for M1 between normal renal function group (Reference) and the mild impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||185.17|95.08|
70945464|NCT04260464|141391714|OTHER||Test/Reference Ratio|122.04|||||TWO_SIDED|90.0|84.47|176.3||||||ANOVA was used to compare the natural log transformed Cmax for M1 between normal renal function group (Reference) and the moderate impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||176.30|84.47|
71087504|NCT02858401|141681087|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71087505|NCT02858401|141681088|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
70857084|NCT02446743|141200511|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month days after booster or 2nd dose)|vaccine group difference|3.0|||||TWO_SIDED|95.0|-0.6|7.8|||Miettinen and Nurminen score methodx|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||7.8|-0.6|
70857085|NCT02446743|141200511|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-6.0|||||TWO_SIDED|95.0|-15.9|4.6|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.6|-15.9|
70857086|NCT02446743|141200511|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-0.9|6.2|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||6.2|-0.9|
70857087|NCT02446743|141200511|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-0.9|4.1|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.1|-0.9|
70857088|NCT02446743|141200511|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-6.0|||||TWO_SIDED|95.0|-19.2|10.3|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||10.3|-19.2|
70857089|NCT02446743|141200511|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.6|8.8|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.8|-3.6|
71124917|NCT02914561|141756136|SUPERIORITY||Stratified Percentage Difference|12.0||||0.0074|TWO_SIDED|95.0|3.2|20.8|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, ≥1).||20.8|3.2|0.0074
71124918|NCT02914561|141756136|SUPERIORITY||Stratified Percentage Difference|5.5||||0.2159|TWO_SIDED|95.0|-3.2|14.1|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, ≥1).||14.1|-3.2|0.2159
71087506|NCT02858401|141681088|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71087507|NCT02858401|141681088|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71087508|NCT02858401|141681089|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71087509|NCT02858401|141681089|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71087510|NCT02858401|141681089|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71087511|NCT02858401|141681091|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71087512|NCT02858401|141681091|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71087513|NCT02858401|141681091|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71087514|NCT02513550|141681102|SUPERIORITY||Risk Difference (RD)|7.9|||=|0.005|TWO_SIDED||||||Regression, Logistic|||||||=0.005
71087515|NCT02513550|141681102|SUPERIORITY||Risk Difference (RD)|1.9|||=|0.522|TWO_SIDED||||||Regression, Logistic|||||||=0.522
71087516|NCT02513550|141681103|SUPERIORITY||Risk Difference (RD)|6.9|||=|0.006|TWO_SIDED||||||Regression, Logistic|||||||=0.006
71087517|NCT02513550|141681103|SUPERIORITY||Risk Difference (RD)|4.6|||=|0.118|TWO_SIDED||||||Regression, Logistic|||||||=0.118
71087518|NCT03924323|141681138|SUPERIORITY||least squares mean difference|-1.42||||0.0281|TWO_SIDED|95.0|-2.69|-0.15|||mixed-effects model for repeated measure|||||-0.15|-2.69|0.0281
71087519|NCT03924323|141681139|SUPERIORITY||Odds Ratio (OR)|1.253||||0.4521|TWO_SIDED|95.0|0.695|2.258|||generalized linear mixed model (GLMMIX)|||||2.258|0.695|0.4521
71087520|NCT03924323|141681140|SUPERIORITY||Odds Ratio (OR)|1.157||||0.6928|TWO_SIDED|95.0|0.56|2.387|||generalized linear mixed model (GLMMIX)|||||2.387|0.560|0.6928
71087521|NCT02360488|141681244|NON_INFERIORITY|The trial aimed to establish comparable efficacy based upon a non-inferiority margin of 30% of the change in Fugl-Meyer score in the In-Clinic group. Under these assumptions at alpha=0.05 and assuming SD=3.8 points, 124 subjects would need to be enrolled to provide 85% power; this sample was pursued independent of subject dropouts.|Mean Difference (Net)|0.06||||0.96|TWO_SIDED|95.0|-2.14|2.26|||Regression, Linear|The model was adjusted for study site, age, time post-stroke, stroke subtype, and baseline Fugl-Meyer score.||||2.26|-2.14|.96
71087522|NCT04350827|141681255|SUPERIORITY|||||||0.433|||||||ANOVA|||||||0.433
71087523|NCT02357459|141681259|SUPERIORITY|The analysis included all study weeks of data, and was not confined to only that at Baseline and Week 12. Descriptive statistics included number of observations, unadjusted mean, standard deviation, median, minimum and maximum, and baseline adjusted means from the mixed model. Treatment differences from control was presented, and estimated via least squares means from the analysis model along with 95% confidence intervals and associated 2-sided p-values.|Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.47|-0.49||The threshold for significance was \<0.05.|longitudinal mixed repeated measures|||||-0.49|-1.47|<0.0001
71087524|NCT03256578|141681285|SUPERIORITY|||||||0.896|||||||Wilcoxon (Mann-Whitney)|||||||0.896
71087525|NCT03256578|141681286|SUPERIORITY|||||||0.107|||||||Wilcoxon (Mann-Whitney)|||||||0.107
71087526|NCT03256578|141681287|SUPERIORITY|||||||0.847|||||||Wilcoxon (Mann-Whitney)|||||||0.847
71087527|NCT03256578|141681288|SUPERIORITY|||||||0.126|||||||Wilcoxon (Mann-Whitney)|||||||0.126
71087528|NCT03256578|141681289|SUPERIORITY|||||||0.346|||||||Wilcoxon (Mann-Whitney)|||||||0.346
71087529|NCT03256578|141681290|SUPERIORITY|||||||0.094|||||||Wilcoxon (Mann-Whitney)|||||||0.094
71087530|NCT03256578|141681291|SUPERIORITY|||||||0.656|||||||Wilcoxon (Mann-Whitney)|||||||0.656
71087531|NCT03256578|141681292|SUPERIORITY|||||||0.434|||||||Wilcoxon (Mann-Whitney)|||||||0.434
71087532|NCT03256578|141681293|SUPERIORITY|||||||0.903|||||||Wilcoxon (Mann-Whitney)|||||||0.903
71087533|NCT03256578|141681294|SUPERIORITY|||||||0.699|||||||Chi-squared|||||||0.699
71087534|NCT03256578|141681295|SUPERIORITY|||||||0.231|||||||Chi-squared|||||||0.231
71087535|NCT03256578|141681296|SUPERIORITY||Risk Ratio (RR)|0.593||||0.283|TWO_SIDED|95.0|0.225|1.561|||Chi-squared|||||1.561|0.225|0.283
71087536|NCT03256578|141681297|SUPERIORITY||Risk Ratio (RR)|1.864||||0.168|TWO_SIDED|95.0|0.756|4.599|||Chi-squared|||||4.599|0.756|0.168
71087537|NCT03256578|141681298|SUPERIORITY||Risk Ratio (RR)|0.67||||0.024|TWO_SIDED|95.0|0.474|0.947|||Chi-squared|||||0.947|0.474|0.024
71087538|NCT03256578|141681299|SUPERIORITY|||||||0.585|||||||Wilcoxon (Mann-Whitney)|||||||0.585
71087539|NCT03256578|141681300|SUPERIORITY|||||||0.342|||||||Wilcoxon (Mann-Whitney)|||||||0.342
71087540|NCT03256578|141681301|SUPERIORITY|||||||0.431|||||||Wilcoxon (Mann-Whitney)|||||||0.431
71087541|NCT03256578|141681303|SUPERIORITY||Risk Ratio (RR)|1.059||||0.518|TWO_SIDED|95.0|0.854|1.313|||Chi-squared|||||1.313|0.854|0.518
71087542|NCT03256578|141681304|SUPERIORITY||Risk Ratio (RR)|0.951||||0.855|TWO_SIDED|95.0|0.555|1.629|||Chi-squared|||||1.629|0.555|0.855
71124919|NCT02914561|141756136|SUPERIORITY||Stratified Percentage Difference|11.6||||0.011|TWO_SIDED|95.0|2.6|20.6|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||20.6|2.6|0.0110
71124920|NCT02914561|141756136|SUPERIORITY||Stratified Percentage Difference|8.2||||0.0593|TWO_SIDED|95.0|-0.4|16.7|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||16.7|-0.4|0.0593
71124921|NCT02914561|141756137|SUPERIORITY||Stratified Percentage Difference|16.8||||0.0382|TWO_SIDED|95.0|2.0|31.6|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||31.6|2.0|0.0382
70945465|NCT04260464|141391715|OTHER||Test/Reference Ratio|445.99|||||TWO_SIDED|95.0|326.55|609.13||||||ANOVA was used to compare the natural log transformed AUCinf for M1 between normal renal function group (Reference) and the severe impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||609.13|326.55|
71124922|NCT02914561|141756137|SUPERIORITY||Stratified Percentage Difference|5.8||||0.4263|TWO_SIDED|95.0|-8.5|20.0|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||20.0|-8.5|0.4263
71124923|NCT02914561|141756138|SUPERIORITY||Stratified Percentage Difference|10.9||||0.1827|TWO_SIDED|95.0|-4.7|26.4|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No) at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||26.4|-4.7|0.1827
71124924|NCT02914561|141756138|SUPERIORITY||Stratified Percentage Difference|4.0||||0.5944|TWO_SIDED|95.0|-11.1|19.2|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No) at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||19.2|-11.1|0.5944
71124925|NCT02914561|141756139|SUPERIORITY||Stratified Percentage Difference|15.2||||0.0512|TWO_SIDED|95.0|1.0|29.3|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No) at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||29.3|1.0|0.0512
70945466|NCT04260464|141391715|OTHER||Test/Reference Ratio|144.63|||||TWO_SIDED|90.0|112.76|185.5||||||ANOVA was used to compare the natural log transformed AUCinf for M1 between normal renal function group (Reference) and the mild impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||185.50|112.76|
71087543|NCT03256578|141681305|SUPERIORITY||Risk Ratio (RR)|0.994||||0.524|TWO_SIDED|95.0|0.834|1.186|||Chi-squared|||||1.186|0.834|0.524
71087544|NCT03256578|141681306|SUPERIORITY||Risk Ratio (RR)|0.649||||0.28|TWO_SIDED|95.0|0.294|1.434|||Chi-squared|||||1.434|0.294|0.280
71087545|NCT03256578|141681307|SUPERIORITY||Risk Ratio (RR)|1.393||||0.339|TWO_SIDED|95.0|0.703|2.76|||Chi-squared|||||2.760|0.703|0.339
71087546|NCT03256578|141681308|SUPERIORITY|||||||0.486|||||||Chi-squared|||||||0.486
71087547|NCT03256578|141681309|SUPERIORITY|||||||0.655|||||||Chi-squared|||||||0.655
71087548|NCT03256578|141681310|SUPERIORITY||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|0.99|1.02|||Chi-squared|||||1.02|0.99|1.00
71087549|NCT02371616|141681311|NON_INFERIORITY|Inferences: upper end of the 2-sided 95% CI for the treatment difference for the estimated effect of Test relative to Comparator, for success, should be \<=6mm. (i.e., Test is no more than 6mm inferior to Comparator).|Least square (LS) mean difference|2.67||||0.2678|TWO_SIDED|95.0|-2.06|7.4||From ANCOVA model: change from baseline as the response variable, treatment group, baseline Schiff stratum and study site as fixed effects, with baseline VAS score as covariate.|ANCOVA||Difference is first named treatment minus second named dentifrice such that a negative difference favors the first named treatment.|Statistical analysis applies to change from baseline at week 8 for test and comparator dentifrice.||7.40|-2.06|0.2678
71087550|NCT00754741|141681315|SUPERIORITY_OR_OTHER|||||||0.763|TWO_SIDED||||||ANOVA|||||||0.763
71087551|NCT00754741|141681315|SUPERIORITY_OR_OTHER|||||||0.285|TWO_SIDED||||||ANOVA|||||||0.285
71087552|NCT00754741|141681316|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED||||||ANOVA|||||||0.380
71087553|NCT00754741|141681316|SUPERIORITY_OR_OTHER|||||||0.084|TWO_SIDED||||||ANOVA|||||||0.084
71087554|NCT00754741|141681317|SUPERIORITY_OR_OTHER|||||||0.667|TWO_SIDED||||||ANOVA|||||||0.667
71087555|NCT00754741|141681317|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||ANOVA|||||||0.530
71124926|NCT02914561|141756139|SUPERIORITY||Stratified Percentage Difference|-0.2||||0.9801|TWO_SIDED|95.0|-13.3|13.0|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No) at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||13.0|-13.3|0.9801
71124927|NCT02914561|141756140|SUPERIORITY||Stratified Percentage Difference|14.0||||0.19|TWO_SIDED|95.0|-5.1|33.1|||Cochran-Mantel-Haenszel|||CMH test was stratified by immunomodulators (Yes) at Maintenance baseline, immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (Yes), and immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (No).||33.1|-5.1|0.1900
71124928|NCT02914561|141756140|SUPERIORITY||Stratified Percentage Difference|-5.5||||0.4248|TWO_SIDED|95.0|-22.6|11.6|||Cochran-Mantel-Haenszel|||CMH test was stratified by immunomodulators (Yes) at Maintenance baseline, immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (Yes), and immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (No).||11.6|-22.6|0.4248
71124929|NCT02914561|141756141|SUPERIORITY||Stratified Percentage Difference|19.9||||0.0122|TWO_SIDED|95.0|5.7|34.0|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||34.0|5.7|0.0122
71124930|NCT02914561|141756141|SUPERIORITY||Stratified Percentage Difference|2.0||||0.7708|TWO_SIDED|95.0|-12.0|16.1|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||16.1|-12.0|0.7708
71124931|NCT02914561|141756142|SUPERIORITY||Stratified Percentage Difference|12.0||||0.2631|TWO_SIDED|95.0|-8.3|32.3|||Cochran-Mantel-Haenszel|||CMH test was stratified by immunomodulators (Yes) at Maintenance baseline, immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (Yes), and immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (No).||32.3|-8.3|0.2631
71124932|NCT02914561|141756142|SUPERIORITY||Stratified Percentage Difference|-3.4||||0.6444|TWO_SIDED|95.0|-20.9|14.0|||Cochran-Mantel-Haenszel|||CMH test was stratified by immunomodulators (Yes) at Maintenance baseline, immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (Yes), and immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (No).||14.0|-20.9|0.6444
71124933|NCT04881747|141756167|EQUIVALENCE|Model: Log(PK) = Treatment + Sequence + Period + Participant(Sequence) + Random Error, where participant within sequence is fitted as a random effect.|Ratio of Geometric least squares mean|0.875|||||TWO_SIDED|90.0|0.834|0.919||||||||0.919|0.834|
71087556|NCT00754741|141681318|SUPERIORITY_OR_OTHER|||||||0.881|TWO_SIDED||||||ANOVA|||||||0.881
70945467|NCT04260464|141391715|OTHER||Test/Reference Ratio|229.12|||||TWO_SIDED|90.0|189.97|276.35||||||ANOVA was used to compare the natural log transformed AUCinf for M1 between normal renal function group (Reference) and the moderate impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||276.35|189.97|
70945468|NCT03469492|141391721|SUPERIORITY|||||||0.006|||||||Regression, Linear|||||||0.006
70945469|NCT03469492|141391725|SUPERIORITY|||||||0.266|||||||Mixed Models Analysis|||||||0.266
70945470|NCT03469492|141391728|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
70945471|NCT03469492|141391729|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||0.25
70945472|NCT01726049|141391731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|||||TWO_SIDED|95.0|-4.5|-0.3||||||||-0.3|-4.5|
71087557|NCT00754741|141681318|SUPERIORITY_OR_OTHER|||||||0.849|TWO_SIDED||||||ANOVA|||||||0.849
71087558|NCT00754741|141681319|SUPERIORITY_OR_OTHER|||||||0.134|TWO_SIDED||||||Chi-squared|||||||0.134
70945473|NCT01726049|141391731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|||||TWO_SIDED|95.0|-7.1|-2.3||||||||-2.3|-7.1|
70945474|NCT01726049|141391732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.9|1.4||||||||1.4|-0.9|
70945475|NCT01726049|141391732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-0.3|1.6||||||||1.6|-0.3|
70945476|NCT01726049|141391733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-0.9|0.1||||||||0.1|-0.9|
70945477|NCT01726049|141391733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.5|0.1||||||||0.1|-0.5|
70945478|NCT01726049|141391734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-1.9|1.0||||||||1.0|-1.9|
70945479|NCT01726049|141391734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|||||TWO_SIDED|95.0|-5.2|-1.8||||||||-1.8|-5.2|
70945480|NCT02806505|141391739|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.6746|TWO_SIDED|95.0|0.49|3.06||Assessed by Cochran-Mantel-Haenszel test stratified by country (Brazil, France, Other) and HCV genotype (1 vs. non-1).|Cochran-Mantel-Haenszel|||The odds ratio is the ratio of the odds of a response in the Peginterferon alfa-2a 135 mcg group with the odds of a response in the Peginterferon alfa-2a 90 mcg group.||3.06|0.49|0.6746
70945481|NCT02806505|141391740|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.3923|TWO_SIDED|95.0|0.6|3.76||Assessed by Cochran-Mantel-Haenszel test stratified by country (Brazil, France, Other) and HCV genotype (1 vs. non-1).|Cochran-Mantel-Haenszel|||The odds ratio is the ratio of the odds of a response in the Peginterferon alfa-2a 135 mcg group with the odds of a response in the Peginterferon alfa-2a 90 mcg group.||3.76|0.60|0.3923
70945482|NCT02806505|141391741|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.8843|TWO_SIDED|95.0|0.43|2.68||Assessed by Cochran-Mantel-Haenszel test stratified by country (Brazil, France, Other) and HCV genotype (1 vs. non-1).|Cochran-Mantel-Haenszel|||Week 12: The odds ratio is the ratio of the odds of a response in the Peginterferon alfa-2a 135 mcg group with the odds of a response in the Peginterferon alfa-2a 90 mcg group.||2.68|0.43|0.8843
70945483|NCT02806505|141391741|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.5866|TWO_SIDED|95.0|0.28|2.04||Assessed by Cochran-Mantel-Haenszel test stratified by country (Brazil, France, Other) and HCV genotype (1 vs. non-1).|Cochran-Mantel-Haenszel|||Week 24: The odds ratio is the ratio of the odds of a response in the Peginterferon alfa-2a 135 mcg group with the odds of a response in the Peginterferon alfa-2a 90 mcg group.||2.04|0.28|0.5866
71087559|NCT00754741|141681319|SUPERIORITY_OR_OTHER|||||||0.714|TWO_SIDED||||||Chi-squared|||||||0.714
71087560|NCT00754741|141681320|SUPERIORITY_OR_OTHER|||||||0.291|TWO_SIDED||||||ANOVA|||||||0.291
71087561|NCT00754741|141681320|SUPERIORITY_OR_OTHER|||||||0.968|TWO_SIDED||||||ANOVA|||||||0.968
70857090|NCT02446743|141200511|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.6|4.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.4|-3.6|
70945484|NCT02416713|141391744|SUPERIORITY||relative change from baseline|0.66||||0.12|TWO_SIDED|95.0|-0.18|1.51|||Mixed Models Analysis|||||1.51|-0.18|0.12
71087562|NCT00754741|141681321|SUPERIORITY_OR_OTHER|||||||0.671|TWO_SIDED||||||ANOVA|||||||0.671
71087563|NCT00754741|141681321|SUPERIORITY_OR_OTHER|||||||0.399|TWO_SIDED||||||ANOVA|||||||0.399
71087564|NCT00754741|141681322|SUPERIORITY_OR_OTHER|||||||0.829|TWO_SIDED||||||ANOVA|||||||0.829
71087565|NCT00754741|141681322|SUPERIORITY_OR_OTHER|||||||0.283|TWO_SIDED||||||ANOVA|||||||0.283
71087566|NCT00754741|141681323|SUPERIORITY_OR_OTHER|||||||0.971|TWO_SIDED||||||ANOVA|||||||0.971
71087567|NCT00754741|141681323|SUPERIORITY_OR_OTHER|||||||0.115|TWO_SIDED||||||ANOVA|||||||0.115
71087568|NCT00754741|141681324|SUPERIORITY_OR_OTHER|||||||0.573|TWO_SIDED||||||ANOVA|||||||0.573
71087569|NCT00754741|141681324|SUPERIORITY_OR_OTHER|||||||0.443|TWO_SIDED||||||ANOVA|||||||0.443
71087570|NCT00754741|141681325|SUPERIORITY_OR_OTHER|||||||0.469|TWO_SIDED||||||ANOVA|||||||0.469
71087571|NCT00754741|141681325|SUPERIORITY_OR_OTHER|||||||0.369|TWO_SIDED||||||ANOVA|||||||0.369
71087572|NCT00754741|141681326|SUPERIORITY_OR_OTHER|||||||0.779|TWO_SIDED||||||ANOVA|||||||0.779
71087573|NCT00754741|141681326|SUPERIORITY_OR_OTHER|||||||0.733|TWO_SIDED||||||ANOVA|||||||0.733
71087574|NCT00754741|141681327|SUPERIORITY_OR_OTHER|||||||0.952|TWO_SIDED||||||ANOVA|||||||0.952
71087575|NCT00754741|141681327|SUPERIORITY_OR_OTHER|||||||0.856|TWO_SIDED||||||ANOVA|||||||0.856
71087576|NCT00754741|141681328|SUPERIORITY_OR_OTHER|||||||0.419|TWO_SIDED||||||Chi-squared|||||||0.419
71087577|NCT00754741|141681328|SUPERIORITY_OR_OTHER|||||||0.998|TWO_SIDED||||||Chi-squared|||||||0.998
71087578|NCT00922636|141681329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.74||||0.008||95.0||||Statistical significance was assessed at an alpha level of 0.027 with a Dunnett adjustment for multiple comparisons.|Mixed Models Analysis|The Least Squares (LS) Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis.|The LS Mean difference was computed as treatment minus placebo.|||||0.008
71087579|NCT00922636|141681329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.04||||0.006||95.0||||Statistical significance was assessed at an alpha level of 0.027 with a Dunnett adjustment for multiple comparisons.|Mixed Models Analysis|The Least Squares (LS) Mean Value is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis.|The LS Mean difference was computed as treatment minus placebo.|||||0.006
71087580|NCT00922636|141681332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.938||95.0||||Statistical significance was assessed at an alpha level of 0.027 with a Dunnett adjustment for multiple comparisons.|Mixed Models Analysis|Least squares (LS) mean is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis.||Gated secondary analysis for total score. If both LY2216684 groups (0.2 mg/kg/day and 0.3 mg/kg/day) were statistically significantly superior than placebo for the primary endpoint, then gated secondary analysis was assessed at an alpha level of 0.027. If only 0.2 mg/kg/day or 0.3 mg/kg/day LY2216684 was statistically significantly superior than placebo for the primary endpoint, then gated secondary analysis was assessed at an alpha level of 0.023 for the corresponding group.||||0.938
71087581|NCT00922636|141681332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.44||||0.002||95.0||||Statistical significance was assessed at an alpha level of 0.027 with a Dunnett adjustment for multiple comparisons.|Mixed Models Analysis|Least squares (LS) mean is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis.||Gated secondary analysis for total score. If both LY2216684 groups (0.2 mg/kg/day and 0.3 mg/kg/day) were statistically significantly superior than placebo for the primary endpoint, then gated secondary analysis was assessed at an alpha level of 0.027. If only 0.2 mg/kg/day or 0.3 mg/kg/day LY2216684 was statistically significantly superior than placebo for the primary endpoint, then gated secondary analysis was assessed at an alpha level of 0.023 for the corresponding group.||||0.002
71087582|NCT03028142|141681387|OTHER||LS Means ratio|1.05||||0.0022|TWO_SIDED|95.0|1.02|1.09|||ANCOVA|||||1.09|1.02|0.0022
71087583|NCT03028142|141681387|OTHER||LS Means ratio|1.09|||<|0.0001|TWO_SIDED|95.0|1.05|1.12|||ANCOVA|||||1.12|1.05|<0.0001
70945485|NCT02416713|141391744|SUPERIORITY||relative change from baseline|-0.3||||0.49|TWO_SIDED|95.0|-1.17|0.57|||Mixed Models Analysis|||||0.57|-1.17|0.49
71087584|NCT03028142|141681388|OTHER||LS Means ratio|1.03||||0.0988|TWO_SIDED|95.0|0.99|1.06|||ANCOVA|||||1.06|0.99|0.0988
71087585|NCT03028142|141681388|OTHER||LS Means ratio|1.06||||0.0009|TWO_SIDED|95.0|1.02|1.09|||ANCOVA|||||1.09|1.02|0.0009
71087586|NCT03028142|141681389|OTHER||LS Means ratio|1.02||||0.2496|TWO_SIDED|95.0|0.98|1.06|||ANCOVA|||||1.06|0.98|0.2496
71087587|NCT03028142|141681389|OTHER||LS Means ratio|1.06||||0.0039|TWO_SIDED|95.0|1.02|1.1|||ANCOVA|||||1.1|1.02|0.0039
71087588|NCT03028142|141681390|OTHER||LS Means ratio|1.03||||0.1404|TWO_SIDED|95.0|0.99|1.06|||ANCOVA|||||1.06|0.99|0.1404
71087589|NCT03028142|141681390|OTHER||LS Means ratio|1.04||||0.0228|TWO_SIDED|95.0|1.01|1.08|||ANCOVA|||||1.08|1.01|0.0228
71087590|NCT01573000|141681423|SUPERIORITY_OR_OTHER||percentage of participants|50.0|||||TWO_SIDED|95.0|35.0|65.0|||||The estimated value represents the percentage of participants with confirmed response (CR, CCR, PR). The number of participants evaluable for overall response (confirmed and unconfirmed; n=42) is used as the denominator.|||65|35|
71087591|NCT01573000|141681423|SUPERIORITY_OR_OTHER||percentage of participants|22.0|||||TWO_SIDED|95.0|9.0|36.0|||||The estimated value represents the percentage of participants with confirmed response (CR, CCR, PR). The number of participants evaluable for overall response (confirmed and unconfirmed; n=36) is used as the denominator.|||36|9|
71087592|NCT01573000|141681424|SUPERIORITY_OR_OTHER||percentage of participants|16.0|||||TWO_SIDED|95.0|0.0|32.0|||||The estimated value represents the percentage of participants with confirmed response (CR, CCR, PR) before Crossover.|||32|0|
71087593|NCT01573000|141681424|SUPERIORITY_OR_OTHER||percentage of participants|79.0|||||TWO_SIDED|95.0|61.0|97.0|||||The estimated value represents the percentage of participants with confirmed response (CR, CCR, PR) after Crossover.|||97|61|
70945486|NCT02416713|141391744|SUPERIORITY||Slope|-0.16||||0.7|TWO_SIDED|95.0|-1.0|0.69|||Mixed Models Analysis|||||0.69|-1.00|0.70
70945487|NCT00760513|141391767|SUPERIORITY||Mean Difference (Net)|-1.7||||0.48|TWO_SIDED|95.0|-6.3|3.0||The a priori threshold for statistical significance = P\</=0.05|Regression, Linear|Adjusted for baseline value of liver fat percentage||We estimated that a 20% decrease in liver fat with Omacor treatment, assuming a sigma of 0.3, and an alpha of 0.05; with 91 participants completing our trial, we had 86% power to detect a 20% change in liver fat (two tailed test) (see HEPATOLOGY 2014;60:1211-1221).||3.0|-6.3|0.48
70945488|NCT00760513|141391768|SUPERIORITY||Mean Difference (Net)|-0.001||||1|TWO_SIDED|95.0|-0.3|0.3||A priori p value threshold \</=0.5|Regression, Linear|Adjusted for baseline||Based on the available evidence at the time, we assumed that a 0.6-1.0 unit change in fibrosis score might be clinically significant (Hepatology 2008 Feb;47(2):455-460). Consequently, to detect a minimum 0.6 unit change in score (e.g. 9.0 at baseline and 8.4 at the end of the study) with an SD of 1.0, 100 participants would provide \>80% power at the 5% significance level, and with a 15% drop out of participants there would also be \>80% power to detect this effect.||0.3|-0.3|1.0
70945489|NCT00760513|141391769|SUPERIORITY||Mean Difference (Net)|-0.03||||0.9|TWO_SIDED|95.0|-0.4|0.3||A priori threshold for statistical significance p \</=0.05|Regression, Linear|Adjusted for baseline measurement.||There was no power calculation for this end point.||0.3|-0.4|0.9
70945490|NCT01343251|141391773|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED||||||Chi-squared|||||||0.48
70945491|NCT01343251|141391774|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||||||0.02
70945492|NCT01343251|141391775|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED|||||SF-36 Test 1 Total Score|t-test, 2 sided|||||||0.49
70945493|NCT01343251|141391775|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED|||||SF-36 Test 2 Total Score|t-test, 2 sided|||||||0.91
70945494|NCT01343251|141391775|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED|||||SF-36 Test 3 Total Score|t-test, 2 sided|||||||0.67
70945495|NCT01343251|141391775|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||SF-36 Test 4 Total Score|t-test, 2 sided|||||||<0.001
70945496|NCT01343251|141391776|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Chi-squared|||||||0.04
70945497|NCT01343251|141391777|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Chi-squared|||||||0.90
70945498|NCT00362375|141391797|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|||<|0.05|TWO_SIDED|95.0|1.28|4.5|||Generalized Estimating Equation|||GEE cluster-adjusted odds ratio||4.50|1.28|<0.05
70945499|NCT00362375|141391798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48|||<|0.05|TWO_SIDED|95.0|0.2|1.16|||GEE|||||1.16|0.20|<0.05
70945500|NCT00362375|141391799|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39|||<|0.05|TWO_SIDED|95.0|0.99|1.95|||GEE|||||1.95|0.99|<0.05
70945501|NCT00362375|141391800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07|||<|0.05|TWO_SIDED|95.0|0.8|1.44|||GEE|GEE incident rate ratio||||1.44|0.80|<0.05
70945502|NCT00362375|141391801|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44|||<|0.05|TWO_SIDED|95.0|0.76|2.71|||GEE|||||2.71|0.76|<0.05
70945503|NCT02509312|141391874|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||||||0.34
70857091|NCT02446743|141200511|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-6.0|||||TWO_SIDED|95.0|-19.4|9.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||9.1|-19.4|
70945504|NCT02509312|141391875|SUPERIORITY|||||||0.257|||||||Chi-squared|||||||.257
70857092|NCT02446743|141200511|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.5|11.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||11.0|-2.5|
70945505|NCT02509312|141391876|SUPERIORITY|||||||0.085|||||||t-test, 2 sided|||||||0.085
71087594|NCT01573000|141681425|SUPERIORITY_OR_OTHER||percentage of participants|26.0|||||TWO_SIDED|95.0|13.0|39.0|||||The estimated value represents the percentage of participants with complete response. The number of participants evaluable for overall response (confirmed and unconfirmed; n=42) is used as the denominator.|||39|13|
70945506|NCT02509312|141391877|SUPERIORITY|||||||0.164|||||||Wilcoxon (Mann-Whitney)|||||||0.164
70945507|NCT02509312|141391878|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
70945508|NCT02509312|141391879|SUPERIORITY||Risk Difference (RD)|-0.27||||0.0367|TWO_SIDED|95.0|-0.52|-0.03|||Chi-squared|||||-0.03|-0.52|0.0367
70945509|NCT02509312|141391880|SUPERIORITY|||||||0.0231|||||||Wilcoxon (Mann-Whitney)|||||||0.0231
70945510|NCT02509312|141391881|SUPERIORITY|||||||0.467|||||||Wilcoxon (Mann-Whitney)|||||||0.467
70945511|NCT02509312|141391882|SUPERIORITY|||||||0.273|||||||Wilcoxon (Mann-Whitney)|||||||0.273
70945512|NCT02509312|141391883|SUPERIORITY|||||||0.0162||||||p-value for 12 hours post-op between-group comparison.|t-test, 2 sided|||||||0.0162
70945513|NCT02509312|141391885|SUPERIORITY|||||||0.048||||||p-value for 6 hours post-op between-group comparison.|Wilcoxon (Mann-Whitney)|||||||0.048
70945514|NCT00704171|141391899|SUPERIORITY_OR_OTHER|||||||0.257|||||||Fisher Exact|||Primary objective was to demonstrate superiority of PleuraSeal as an adjunct compared to standard of care alone. Tissue closure rates for the treatment and control groups were assumed to be 0.40 and 0.15, respectively. To achieve 80 percent power (alpha=0.05, 2-tailed, Fisher's Exact Test) required 112 completed subjects. To account for potential subject withdrawals, an additional 8 subjects were to be enrolled for a total of 120 randomized subjects (approx. 60 per treatment group).||||0.257
70945515|NCT00704171|141391900|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|two-sided||||||<0.001
70945516|NCT00704171|141391901|SUPERIORITY_OR_OTHER|||||||0.79|||||||Kaplan-Meier|Kaplan-Meier method was used to obtain estimated median times for each treatment group and the log-rank test was used to compare the two treatments.||||||0.790
70945517|NCT00704171|141391902|SUPERIORITY_OR_OTHER|||||||0.559|||||||2-sample t-test|||||||0.559
70945518|NCT00704171|141391903|SUPERIORITY_OR_OTHER|||||||0.292|||||||2-sample t-test|||||||0.292
70945519|NCT00704171|141391904|SUPERIORITY_OR_OTHER|||||||0.53||||||For subgroup with pre-randomization air leak grade of 1|Fisher Exact|||||||0.53
70945520|NCT00704171|141391904|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||For subgroup with pre-randomization air leak grade of 2 or 3|Fisher Exact|||||||.013
71087595|NCT01573000|141681425|SUPERIORITY_OR_OTHER||percentage of participants|8.0|||||TWO_SIDED|95.0|0.0|17.0|||||The estimated value represents the percentage of participants with complete response. The number of participants evaluable for overall response (confirmed and unconfirmed; n=36) is used as the denominator.|||17|0|
71087596|NCT01573000|141681426|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Fisher Exact|||||||0.012
71087597|NCT01573000|141681427|SUPERIORITY_OR_OTHER||percentage of participants|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated value represents the percentage of participants with confirmed complete response before Crossover.|||0|0|
71087598|NCT01573000|141681427|SUPERIORITY_OR_OTHER||percentage of participants|42.0|||||TWO_SIDED|95.0|20.0|64.0|||||The estimated value represents the percentage of participants with confirmed complete response after Crossover.|||64|20|
71087599|NCT01573000|141681428|SUPERIORITY_OR_OTHER||percentage of participants|2.0|||||TWO_SIDED|95.0|0.0|7.0|||||The estimated value represents the percentage of participants with confirmed CCR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=42) is used as the denominator.|||7|0|
71087600|NCT01573000|141681428|SUPERIORITY_OR_OTHER||percentage of participants|3.0|||||TWO_SIDED|95.0|0.0|8.0|||||The estimated value represents the percentage of participants with confirmed CCR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=36) is used as the denominator.|||8|0|
71087601|NCT01573000|141681429|SUPERIORITY_OR_OTHER||percentage of participants|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated value represents the percentage of participants with confirmed CCR before Crossover.|||0|0|
70945521|NCT04269434|141391919|NON_INFERIORITY|"The No Screening Arm is considered non-inferior if the upper limit of the 95% Confidence Interval is less than 1.25"|Incidence rate ratio|1.318|||||TWO_SIDED|95.0|1.068|1.627||||||Compared to screening group||1.627|1.068|
70945522|NCT04269434|141391920|NON_INFERIORITY|No prespecified margin|Incidence rate ratio|0.788|||||TWO_SIDED|95.0|0.719|0.863||||||For Azithromycin. Compared to screening group||0.863|0.719|
70945523|NCT04269434|141391920|NON_INFERIORITY|No prespecified margin|Incidence rate ratio|0.561|||||TWO_SIDED|95.0|0.426|0.739||||||For Ceftriaxone. Compared to screening group||0.739|0.426|
70945524|NCT04269434|141391920|NON_INFERIORITY|No prespecified margin|Incidence rate ratio|0.55|||||TWO_SIDED|95.0|0.515|0.588||||||For Doxycycline. Compared to screening group||0.588|0.515|
70945525|NCT04269434|141391921|NON_INFERIORITY|No prespecified margin.|Incidence rate ratio|1.373|||||TWO_SIDED|95.0|0.963|1.956||||||Compared to screening group||1.956|0.963|
70945526|NCT04269434|141391922|NON_INFERIORITY|No prespecified margin.|Incidence rate ratio|1.471|||||TWO_SIDED|95.0|0.943|2.299||||||Compared to screening group||2.299|0.943|
70945527|NCT04962698|141391923|SUPERIORITY||||||>|0.00238||||||The threshold for statistical significance was 0.00238, which was adjusted from the original 0.05 as described below.|Wilcoxon (Mann-Whitney)|The alpha value for p-value comparison was adjusted for 21 pair-wise comparisons (0.05/21 = 0.00238) across seven tasks.||||||>0.00238
70945528|NCT04962698|141391924|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was 0.05.|ANOVA|||||||<0.001
70945529|NCT04962698|141391925|SUPERIORITY|||||||0.028||||||The threshold for statistical significance was 0.05.|ANOVA|||||||0.028
70945530|NCT04962698|141391926|SUPERIORITY||||||<|0.00231||||||The threshold for statistical significance was 0.00238, which was adjusted from the original 0.05 as described below.|Wilcoxon (Mann-Whitney)|The alpha value for p-value comparison was adjusted for 21 pair-wise comparisons (0.05/21 = 0.00238) across seven tasks.||||||<0.00231
70945531|NCT04962698|141391927|SUPERIORITY||||||<|0.002||||||The threshold for statistical significance was 0.00238, which was adjusted from the original 0.05 as described below.|Wilcoxon (Mann-Whitney)|The alpha value for p-value comparison was adjusted for 21 pair-wise comparisons (0.05/21 = 0.00238) across seven tasks.||||||<0.0020
70945532|NCT03247738|141391991|SUPERIORITY|The primary end point of our study was the comparison of platelet reactivity measured by VerifyNow PRU between cangrelor and placebo at 30 minutes after drugs were administered at the start of PCI. Assuming a common standard deviation of 70 PRU, a sample size of 20 patients per group would allow detection of a 70 PRU difference between groups with 85% power and a two-sided α = 0.05. Considering the 2 arms and a possible 25% rate of invalid PD results we planned to randomize up to 50 patients.|Mean Difference (Net)|152.0|||<|0.001|TWO_SIDED|95.0|108.0|195.0|||ANCOVA|the baseline value of platelet reactivity used as a covariate||||195|108|<0.001
70945533|NCT02561806|141392016|NON_INFERIORITY|Non-inferiority margin was -12.6% for 97.5% confidence interval|Risk Difference (RD)|0.321|||<|0.001|TWO_SIDED|97.5|0.198|0.445|||Regression, Logistic|||||0.445|0.198|<0.001
70945534|NCT02561806|141392017|SUPERIORITY||Risk Ratio (RR)|1.285|||<|0.001|TWO_SIDED|95.0|1.13|1.439|||Regression, Logistic|||||1.439|1.130|<0.001
70945535|NCT02561806|141392018|SUPERIORITY||Risk Ratio (RR)|2.699||||0.009|TWO_SIDED|95.0|1.423|3.975|||Regression, Logistic|||||3.975|1.423|0.009
71087602|NCT01573000|141681429|SUPERIORITY_OR_OTHER||percentage of participants|5.0|||||TWO_SIDED|95.0|0.0|15.0|||||The estimated value represents the percentage of participants with confirmed CCR after Crossover.|||15|0|
70857093|NCT02446743|141200511|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.3|7.8|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||7.8|-2.3|
70945536|NCT02561806|141392019|SUPERIORITY||Risk Ratio (RR)|1.469|||<|0.001|TWO_SIDED|95.0|1.244|1.695|||Regression, Logistic|||||1.695|1.244|<0.001
70945537|NCT02561806|141392020|SUPERIORITY||Risk Ratio (RR)|3.421||||0.021|TWO_SIDED|95.0|1.353|5.488|||Regression, Logistic|||||5.488|1.353|0.021
70945538|NCT02561806|141392027|SUPERIORITY||Risk Ratio (RR)|1.391||||0.012|TWO_SIDED|95.0|1.085|1.698|||Regression, Logistic|||||1.698|1.085|0.012
70945539|NCT02547441|141392040|SUPERIORITY|||||||0.043|||||||ANCOVA|||||||0.043
70945540|NCT02547441|141392041|SUPERIORITY|||||||0.019|||||||Cochran-Mantel-Haenszel|||||||0.019
70945541|NCT01322009|141392050|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|Analysis run over study period but data entered only for the 6 h time point||||||>0.05
70945542|NCT01657877|141392053|NON_INFERIORITY_OR_EQUIVALENCE|The success criterion for this study was to observe the upper bound of the 2-sided 95% confidence interval for difference in % change in SMHR to be \<= 6 units SMHR i.e. 1500 ppm fluoride as SMFP + 5% CSP is no more than 6 units inferior to the 1500 ppm fluoride as SMFP + 0 % CSP dentifrice.|Adjusted mean difference|-2.23||||0.2601|TWO_SIDED|95.0|-6.11|1.66|||ANOVA|Based on the mixed effects ANOVA considering treatment and study period as factors, and subject as random effect|Difference is 1500 ppm fluoride as SMFP and 0 % CSP minus 1500 ppm fluoride as SMFP and 5 % CSP such that a positive difference favors 1500 ppm fluoride as SMFP and 0 % CSP|The null hypothesis states that the population mean for the 1500 ppm fluoride as SMFP + 0% CSP minus the population mean for the 1500 ppm fluoride as SMFP and 5% CSP dentifrice is more than 6 %.||1.66|-6.11|0.2601
70945543|NCT00511797|141392083|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.49|-0.34||Pre-defined sequential tests were applied to protect alpha inflation by multiplicity.|t-test, 1 sided|||Three null hypotheses were sequentially tested. H01: DRSP 3 mg \>= Placebo (Active is equal or less in decrease of score) vs H11: DRSP 3 mg \< Placebo (Active is greater in decrease of score), H02: DRSP 2 mg \>= Placebo vs H12: DRSP 2 mg \< Placebo, H03: DRSP 1 mg \>= Placebo vs H13: DRSP 1 mg \< Placebo.||-0.34|-1.49|<0.001
70945544|NCT00511797|141392083|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.277|<|0.001||95.0|-1.64|-0.55|||t-test, 1 sided|||Second null hypothesis was tested. H02: DRSP 2 mg \>= Placebo vs H12: DRSP 2 mg \< Placebo.||-0.55|-1.64|<0.001
70945545|NCT00511797|141392083|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|0.28|<|0.001||95.0|-2.0|-0.89|||t-test, 1 sided|||Third null hypotheses was tested. H03: DRSP 1 mg \>= Placebo vs H13: DRSP 1 mg \< Placebo.||-0.89|-2.00|<0.001
70945546|NCT00511797|141392084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.322|<|0.001|TWO_SIDED|95.0|-1.74|-0.46|||t-test, 1 sided|||Test results of 3 mg DRSP and placebo at Cycle 4 are shown. 2-sided 95% confidence intervals were calculated. To keep consistency with 2-sided 95% confidence intervals, 2.5% 1-sided significance levels were used for the statistical tests.||-0.46|-1.74|<0.001
70945547|NCT00511797|141392084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34|STANDARD_ERROR_OF_MEAN|0.306|<|0.001||95.0|-1.95|-0.73|||t-test, 1 sided|||||-0.73|-1.95|<0.001
70945548|NCT00511797|141392084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.53|STANDARD_ERROR_OF_MEAN|0.317|<|0.001||95.0|-2.16|-0.9|||t-test, 1 sided|||||-0.90|-2.16|<0.001
70945549|NCT03974100|141392107|EQUIVALENCE|Equivalence criteria (analysis set PPS): 95% CI for difference in means contained in \[-1.45%, 1.45%\]|Mean Difference (Final Values)|-0.145|STANDARD_ERROR_OF_MEAN|0.3325|||TWO_SIDED|95.0|-0.798|0.509|||Mixed-model repeated measures (MMRM)|MMRM included treatment, prior bisphosphonate use, DXA machine type, visit, visit-treatment interaction, and baseline LS-BMD as a continuous covariate|Difference GP2411 (Test) - EU-Prolia (Reference)|||0.509|-0.798|
70945550|NCT03974100|141392108|EQUIVALENCE|Equivalence criteria (analysis set TP1 FAS): 95% CI for difference in means contained in \[-1.45%, 1.45%\] (criteria 1) or in \[-2.00%, 2.00%\] (criteria 2)|Mean Difference (Final Values)|-0.177|STANDARD_ERROR_OF_MEAN|0.3321|||TWO_SIDED|95.0|-0.83|0.475|||Mixed-model repeated measures (MMRM)|MMRM included treatment, prior bisphosphonate use, DXA machine type, visit, visit-treatment interaction, and baseline LS-BMD as a continuous covariate|Difference GP2411 (Test) - EU-Prolia (Reference)|||0.475|-0.830|
70945551|NCT03974100|141392109|EQUIVALENCE|Equivalence criteria (analysis set PDS): 95% CI for ratio of geometric means contained in \[0.80, 1.25%\]|Geometric mean ratio|1.0|||||TWO_SIDED|95.0|0.98|1.01|||ANCOVA|ANCOVA was performed on log-transformed AUEC including treatment and log baseline CTX value as a continuous covariate|Geometric mean ratio of GP2411 (Test) to EU-Prolia (Reference)|||1.01|0.98|
70945552|NCT03974100|141392109|EQUIVALENCE|Equivalence criteria (analysis set PDS): 90% CI for ratio of geometric means contained in \[0.80, 1.25%\]|Geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.98|1.01|||ANCOVA|ANCOVA was performed on log-transformed AUEC including treatment and log baseline CTX value as a continuous covariate|Geometric mean ratio of GP2411 (Test) to EU-Prolia (Reference)|||1.01|0.98|
70945553|NCT03974100|141392110|EQUIVALENCE|Equivalence criteria (analysis set PKS): 90% CI for ratio of geometric means contained in \[0.80, 1.25%\]|Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.92|1.03|||ANCOVA|ANCOVA was performed on log-transformed Cmax including treatment and weight as a continuous covariate|Geometric mean ratio of GP2411 (Test) to EU-Prolia (Reference)|||1.03|0.92|
70945554|NCT03974100|141392111|EQUIVALENCE|Equivalence criteria (analysis set PKS): 90% CI for ratio of geometric means contained in \[0.80, 1.25%\]|Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.93|1.05|||ANCOVA|ANCOVA was performed on log-transformed AUCinf including treatment and weight as a continuous covariate|Geometric mean ratio of GP2411 (Test) to EU-Prolia (Reference)|||1.05|0.93|
70945555|NCT03398421|141392138|SUPERIORITY||Ratio of adjusted geometric mean|2.005|||||TWO_SIDED|90.0|1.807|2.224||||||||2.224|1.807|
70945556|NCT03398421|141392145|SUPERIORITY||Ratio of adjusted geometric mean|0.802|||||TWO_SIDED|90.0|0.69|0.933||||||||0.933|0.690|
70945557|NCT03269695|141392193|SUPERIORITY||Treatment difference|1.8||||1|TWO_SIDED|95.0|-41.0|47.2|||Chan and Zhang (1999)|||||47.2|-41.0|1.0000
70945558|NCT03269695|141392194|SUPERIORITY||Treatment difference|0.0||||1|TWO_SIDED|95.0|-37.0|37.0|||Chan and Zhang (1999)|||||37.0|-37.0|1.0000
70945559|NCT03269695|141392195|SUPERIORITY||Treatment difference|14.3||||0.47|TWO_SIDED|95.0|-23.8|57.9|||Chan and Zhang (1999)|||||57.9|-23.8|0.4700
70945560|NCT03269695|141392196|SUPERIORITY||Treatment difference|10.0||||0.5221|TWO_SIDED|95.0|-20.7|45.6|||Chan and Zhang (1999)|||||45.6|-20.7|0.5221
70945561|NCT03269695|141392197|SUPERIORITY||Treatment difference|32.1||||0.3166|TWO_SIDED|95.0|-23.7|74.1|||Chan and Zhang (1999)|||||74.1|-23.7|0.3166
71087603|NCT01573000|141681430|SUPERIORITY_OR_OTHER||percentage of participants|31.0|||||TWO_SIDED|95.0|17.0|45.0|||||The estimated value represents the percentage of participants with confirmed CR and CCR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=42) is used as the denominator.|||45|17|
70945562|NCT03269695|141392198|SUPERIORITY||Treatment difference|20.0||||0.5234|TWO_SIDED|95.0|-22.9|58.5|||Chan and Zhang (1999)|||||58.5|-22.9|0.5234
70945563|NCT03269695|141392199|SUPERIORITY||Treatment difference|-25.0||||0.7393|TWO_SIDED|95.0|-69.6|29.1|||Chan and Zhang (1999)|||||29.1|-69.6|0.7393
71087604|NCT01573000|141681430|SUPERIORITY_OR_OTHER||percentage of participants|11.0|||||TWO_SIDED|95.0|1.0|21.0|||||The estimated value represents the percentage of participants with confirmed CR and CCR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=36) is used as the denominator.|||21|1|
71087605|NCT01573000|141681431|SUPERIORITY_OR_OTHER||percentage of participants|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated value represents the percentage of participants with confirmed CR and CCR before Crossover.|||0|0|
70945564|NCT03269695|141392200|SUPERIORITY||Least squares mean difference|5.8||||0.2705|TWO_SIDED|95.0|-5.08|16.67|||ANCOVA|||||16.67|-5.08|0.2705
70857094|NCT02446743|141200511|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-26.0|||||TWO_SIDED|95.0|-36.6|-15.7|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||-15.7|-36.6|
70945565|NCT03269695|141392201|SUPERIORITY||Treatment difference|48.2||||0.0732|TWO_SIDED|95.0|-4.4|84.7|||Chan and Zhang (1999)|||||84.7|-4.4|0.0732
70945566|NCT03269695|141392202|SUPERIORITY||Treatment difference|30.0||||0.2633|TWO_SIDED|95.0|-18.4|69.2|||Chan and Zhang (1999)|||||69.2|-18.4|0.2633
70945567|NCT03269695|141392203|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.15|6.54|||Generalized Linear Mixed Model|||At Week 2||6.54|0.15|1.0000
70945568|NCT03269695|141392203|SUPERIORITY||Odds Ratio (OR)|1.5||||0.6691|TWO_SIDED|95.0|0.23|10.0|||Generalized Linear Mixed Model|||At Week 4||10.00|0.23|0.6691
71087606|NCT01573000|141681431|SUPERIORITY_OR_OTHER||percentage of participants|47.0|||||TWO_SIDED|95.0|25.0|70.0|||||The estimated value represents the percentage of participants with confirmed CR and CCR after Crossover.|||70|25|
71087607|NCT01573000|141681432|SUPERIORITY_OR_OTHER||percentage of participants|17.0|||||TWO_SIDED|95.0|5.0|28.0|||||The estimated value represents the percentage of participants with confirmed PR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=42) is used as the denominator.|||28|5|
71087608|NCT01573000|141681432|SUPERIORITY_OR_OTHER||percentage of participants|11.0|||||TWO_SIDED|95.0|1.0|21.0|||||The estimated value represents the percentage of participants with confirmed PR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=36) is used as the denominator.|||21|1|
71087609|NCT01573000|141681433|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||||||0.001
71087610|NCT01573000|141681435|SUPERIORITY_OR_OTHER|||||||0.495||95.0|||||Log Rank|||||||0.495
71087611|NCT01573000|141681436|SUPERIORITY_OR_OTHER|||||||0.677||95.0|||||Log Rank|||||||0.677
71087612|NCT01573000|141681439|SUPERIORITY_OR_OTHER|||||||0.119||95.0|||||Log Rank|||||||0.119
71087613|NCT01573000|141681440|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||Log Rank|||||||0.016
71087614|NCT01573000|141681453|SUPERIORITY_OR_OTHER||percentage of participants|16.0|||||TWO_SIDED|95.0|0.0|32.0|||||The estimated value represents the percentage of participants with confirmed PR before Crossover.|||32|0|
71087615|NCT01573000|141681453|SUPERIORITY_OR_OTHER||percentage of participants|32.0|||||TWO_SIDED|95.0|11.0|52.0|||||The estimated value represents the percentage of participants with confirmed PR after Crossover.|||52|11|
71087616|NCT02351934|141681466|SUPERIORITY|||||||0.564|||||||Wilcoxon (Mann-Whitney)|||Significance level of 0.05 was used.||||0.564
71124934|NCT04881747|141756167|EQUIVALENCE|Model: Log(PK) = Treatment + Sequence + Period + Participant(Sequence) + Random Error, where participant within sequence is fitted as a random effect.|Ratio of Geometric least squares mean|0.889|||||TWO_SIDED|90.0|0.846|0.934||||||||0.934|0.846|
71124935|NCT04881747|141756168|EQUIVALENCE|Model: Log(PK) = Treatment + Sequence + Period + Participant(Sequence) + Random Error, where participant within sequence is fitted as a random effect.|Ratio of Geometric least squares mean|0.944|||||TWO_SIDED|90.0|0.914|0.976||||||||0.976|0.914|
71124936|NCT04881747|141756168|EQUIVALENCE|Model: Log(PK) = Treatment + Sequence + Period + Participant(Sequence) + Random Error, where participant within sequence is fitted as a random effect.|Ratio of Geometric least squares mean|0.946|||||TWO_SIDED|90.0|0.914|0.978||||||||0.978|0.914|
71087617|NCT02351934|141681467|SUPERIORITY|||||||0.675|||||||Wilcoxon (Mann-Whitney)|||Significance level of 0.05 was used.||||0.675
71087618|NCT02351934|141681468|SUPERIORITY|||||||0.125|||||||Wilcoxon (Mann-Whitney)|||Significance level of 0.05 was used.||||0.125
71087619|NCT02351934|141681470|SUPERIORITY|||||||0.595|||||||Wilcoxon (Mann-Whitney)|||Significance level of 0.05 was used.||||0.595
71124937|NCT04881747|141756169|EQUIVALENCE|Model: Log(PK) = Treatment + Sequence + Period + Participant(Sequence) + Random Error, where participant within sequence is fitted as a random effect.|Ratio of Geometric least squares mean|0.941|||||TWO_SIDED|90.0|0.91|0.972||||||||0.972|0.910|
71087620|NCT02351934|141681471|SUPERIORITY|||||||0.985|||||||Wilcoxon (Mann-Whitney)|||Significance level of 0.05 was used.||||0.985
71087621|NCT01115452|141681472|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.32||||0.9347|TWO_SIDED|95.0|-8.14|7.5||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis was no difference between treatments.||7.50|-8.14|0.9347
71087622|NCT01115452|141681473|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.02||||0.9963|TWO_SIDED|95.0|-8.2|8.24||Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|ANCOVA|No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||8.24|-8.20|0.9963
71087623|NCT01115452|141681473|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.9||||0.3582|TWO_SIDED|95.0|-4.45|12.25||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||12.25|-4.45|0.3582
71124938|NCT04881747|141756169|EQUIVALENCE|Model: Log(PK) = Treatment + Sequence + Period + Participant(Sequence) + Random Error, where participant within sequence is fitted as a random effect.|Ratio of Geometric least squares mean|0.944|||||TWO_SIDED|90.0|0.913|0.977||||||||0.977|0.913|
71124939|NCT04598269|141756170|SUPERIORITY||Least Square Means (LSM) % Differences|-33.01|STANDARD_ERROR_OF_MEAN|8.971|<|0.001|TWO_SIDED|90.0|-47.95|-18.08||P-value is based on a 1-sided hypothesis test of the superiority of ATI-1777 relative to the vehicle. Significance level at α = 0.05.|Mixed Model Repeated Measures (MMRM)||"Fixed factors for treatment, visit, visit\*treatment, baseline measurement. A compound symmetry covariance matrix was used to account for within-subject variability.~Week 4: Least Square Means (LSM) % differences ATI-1777 arm minus vehicle arm"|||-18.08|-47.95|<0.001
71124940|NCT04598269|141756171|SUPERIORITY||LSM % Differences|-23.53|STANDARD_ERROR_OF_MEAN|8.971||0.005|TWO_SIDED|90.0|-38.47|-8.59||P-value is based on a 1-sided hypothesis test of the superiority of ATI-1777 relative to the vehicle. Significance level at α = 0.05.|MMRM||"Fixed factors for treatment, visit, visit\*treatment, baseline measurement. A compound symmetry covariance matrix was used to account for within-subject variability.~Day 8: LSM % differences ATI-1777 arm minus vehicle arm"|Day 8 statistical analysis||-8.59|-38.47|0.005
70945569|NCT03269695|141392203|SUPERIORITY||Odds Ratio (OR)|0.62||||0.6248|TWO_SIDED|95.0|0.09|4.4|||Generalized Linear Mixed Model|||At Week 8||4.40|0.09|0.6248
70857095|NCT02446743|141200511|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|-3.0|||||TWO_SIDED|95.0|-13.3|8.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.5|-13.3|
70945570|NCT03269695|141392203|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9965|TWO_SIDED|95.0|0.12|8.3|||Generalized Linear Mixed Model|||At Week 12||8.30|0.12|0.9965
70857096|NCT02446743|141200511|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|21.0|||||TWO_SIDED|95.0|12.8|28.3|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||28.3|12.8|
70857097|NCT02446743|141200511|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-18.0|||||TWO_SIDED|95.0|-32.5|-5.8|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-5.8|-32.5|
71087624|NCT01115452|141681473|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.88||||0.36|TWO_SIDED|95.0|-4.46|12.22||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||12.22|-4.46|0.3600
71087625|NCT01115452|141681474|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.91||||0.8265|TWO_SIDED|95.0|-9.13|7.3||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||7.30|-9.13|0.8265
71087626|NCT01115452|141681474|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.9||||0.8314|TWO_SIDED|95.0|-9.25|7.45||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||7.45|-9.25|0.8314
71087627|NCT01115452|141681474|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.01||||0.9978|TWO_SIDED|95.0|-8.33|8.35||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||8.35|-8.33|0.9978
71087628|NCT01115452|141681475|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.22||||0.3122|TWO_SIDED|95.0|-4.0|12.44|||ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||12.44|-4.00|0.3122
71087629|NCT01115452|141681475|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.27||||0.7646|TWO_SIDED|95.0|-9.62|7.08||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||7.08|-9.62|0.7646
71087630|NCT01115452|141681475|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.49||||0.1957||95.0|-13.83|2.85||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||2.85|-13.83|0.1957
71087631|NCT01115452|141681476|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.35||||0.7472|TWO_SIDED|95.0|-9.62|6.92||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.92|-9.62|0.7472
70857098|NCT02446743|141200511|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|-7.0|||||TWO_SIDED|95.0|-22.3|9.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||9.5|-22.3|
70954325|NCT03843554|141411196|SUPERIORITY|IL4|Mean Difference (Final Values)|-20.4|STANDARD_ERROR_OF_MEAN|46.0||0.8371|TWO_SIDED|95.0|||||t-test, 2 sided|||The change in the inflammatory marker from baseline to the final intervention visit was analyzed using 95% confidence intervals and presented by treatment group. The two-sided t- test was used to compare the change in inflammatory markers between the two groups.||||0.8371
71087632|NCT01115452|141681476|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.66||||0.8767||95.0|-7.75|9.08||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution|Null hypothesis is no difference between treatments.||9.08|-7.75|0.8767
71087633|NCT01115452|141681476|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.01||||0.6367||95.0|-6.39|10.42||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||10.42|-6.39|0.6367
71124941|NCT04598269|141756171|SUPERIORITY||LSM % Differences|-23.44|STANDARD_ERROR_OF_MEAN|8.971||0.005|TWO_SIDED|90.0|-38.38|-8.5||P-value is based on a 1-sided hypothesis test of the superiority of ATI-1777 relative to the vehicle. Significance level at α = 0.05.|Mixed Models Analysis||"Fixed factors for treatment, visit, visit\*treatment, baseline measurement. A compound symmetry covariance matrix was used to account for within-subject variability.~Day 15: LSM % differences ATI-1777 arm minus vehicle arm"|Day 15 statistical analysis||-8.50|-38.38|0.005
71124942|NCT04598269|141756172|SUPERIORITY||Odds Ratio, log|15.7|||<|0.001|TWO_SIDED|90.0|3.9|63.2||1-sided p-value of responders in the treatment groups at 0.05 level of significance.|Regression, Logistic||Active/Vehicle|||63.2|3.9|<0.001
71124943|NCT04598269|141756173|SUPERIORITY||Odds Ratio, log|5.9||||0.003|TWO_SIDED|90.0|2.1|17.0||1-sided p-value of responders in the treatment groups at 0.05 level of significance|Regression, Linear||Active/Vehicle|||17.0|2.1|0.003
71124944|NCT04598269|141756174|SUPERIORITY||Odds Ratio, log|1.7||||0.203|TWO_SIDED|90.0|0.6|5.3||1-sided p-value of responders in the treatment groups at 0.05 level of significance|Regression, Logistic||Active/Vehicle|||5.3|0.6|0.203
71124945|NCT04598269|141756175|SUPERIORITY|||||||0.148||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Day 8 statistical analysis||||0.148
71124946|NCT04598269|141756175|SUPERIORITY|||||||0.017||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Day 15 statistical analysis||||0.017
71124947|NCT04598269|141756175|SUPERIORITY|||||||0.002||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Week 4 statistical analysis||||0.002
71124948|NCT04598269|141756176|SUPERIORITY|||||||0.088||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Day 8 statistical analysis||||0.088
71124949|NCT04598269|141756176|SUPERIORITY|||||||0.022||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Day 15 statistical analysis||||0.022
71124950|NCT04598269|141756176|SUPERIORITY||||||<|0.001||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance.|MMRM|||Week 4 statistical analysis||||<0.001
71124951|NCT04598269|141756177|SUPERIORITY|||||||0.014||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Day 8 statistical analysis||||0.014
71124952|NCT04598269|141756177|SUPERIORITY|||||||0.069||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Day 15 statistical analysis||||0.069
71124953|NCT04598269|141756177|SUPERIORITY|||||||0.06||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Week 4 statistical analysis||||0.060
71124954|NCT03869333|141756201|OTHER|||||||0.504|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Baseline||||0.504
71124955|NCT03869333|141756201|OTHER|||||||0.01|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 22||||0.010
71124956|NCT03869333|141756201|OTHER|||||||0.038|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 43||||0.038
71124957|NCT03869333|141756201|OTHER|||||||0.016|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 50||||0.016
71124958|NCT03869333|141756201|OTHER|||||||0.058|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 57||||0.058
71124959|NCT03869333|141756201|OTHER|||||||0.038|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 71||||0.038
71124960|NCT03869333|141756202|OTHER|||||||0.129|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Baseline||||0.129
71124961|NCT03869333|141756202|OTHER|||||||0.017|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 22||||0.017
71124962|NCT03869333|141756202|OTHER|||||||0.008|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 43||||0.008
71124963|NCT03869333|141756202|OTHER|||||||0.011|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 50||||0.011
71124964|NCT03869333|141756202|OTHER|||||||0.029|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 57||||0.029
71124965|NCT03869333|141756202|OTHER|||||||0.042|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 71||||0.042
71124966|NCT03869333|141756203|OTHER|||||||0.226|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Baseline||||0.226
70945571|NCT02024750|141392211|OTHER||Mean Difference (Net)|0.005||||0.72|TWO_SIDED|95.0|-0.021|0.03||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Negative values indicate a clinical benefit.|During the intervention period, the treatment effect on A1c. Results reflect the difference in A1c trend between usual care and intervention arms.||0.030|-0.021|0.72
70945572|NCT02024750|141392211|OTHER||Mean Difference (Net)|-0.01||||0.38|TWO_SIDED|95.0|-0.034|0.013||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Negative values indicate a clinical benefit.|During the post-intervention period, the treatment effect on A1c. Results reflect the difference in A1c trend between usual care and intervention arms.||0.013|-0.034|0.38
70945573|NCT02024750|141392212|OTHER||Mean Difference (Net)|0.023||||0.87|TWO_SIDED|95.0|-0.249|0.295||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the intervention period, the treatment effect on child quality of life. Results reflect the difference in QOL trend between usual care and intervention arms.||0.295|-0.249|0.87
71087634|NCT01115452|141681477|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.95||||0.6417|TWO_SIDED|95.0|-10.22|6.32||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.32|-10.22|0.6417
71087635|NCT01115452|141681477|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.43||||0.92|TWO_SIDED|95.0|-7.99|8.85||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||8.85|-7.99|0.9200
71087636|NCT01115452|141681477|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.38||||0.5766||95.0|-6.02|10.78||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||10.78|-6.02|0.5766
70857099|NCT02446743|141200511|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|20.0|||||TWO_SIDED|95.0|8.4|31.3|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||31.3|8.4|
70945574|NCT02024750|141392212|OTHER||Mean Difference (Net)|-0.074||||0.74|TWO_SIDED|95.0|-0.517|0.369||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the post-intervention period, the treatment effect on child quality of life. Results reflect the difference in QOL trend between usual care and intervention arms.||0.369|-0.517|0.74
70945575|NCT02024750|141392213|OTHER||Mean Difference (Net)|-0.037||||0.79|TWO_SIDED|95.0|-0.312|0.237||The a priori threshold for statistical significance was p\<0.05|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the intervention period, the treatment effect on parent quality of life. Results reflect the difference in QOL trend between usual care and intervention arms.||0.237|-0.312|0.79
70945576|NCT02024750|141392213|OTHER||Mean Difference (Net)|-0.009||||0.97|TWO_SIDED|95.0|-0.467|0.448||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the post-intervention period, the treatment effect on parent quality of life. Results reflect the difference in QOL trend between usual care and intervention arms.||0.448|-0.467|0.97
71087637|NCT01115452|141681478|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.58||||0.393|TWO_SIDED|95.0|-11.65|4.68||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||4.68|-11.65|0.3930
71087638|NCT01115452|141681478|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.7||||0.6896|TWO_SIDED|95.0|-10.12|6.71||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.71|-10.12|0.6896
71124967|NCT03869333|141756203|OTHER|||||||0.601|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 8||||0.601
71124968|NCT03869333|141756203|OTHER|||||||0.628|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 29||||0.628
71124969|NCT03869333|141756203|OTHER|||||||0.878|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 50||||0.878
71124970|NCT03869333|141756204|OTHER|||||||0.762|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Baseline||||0.762
71087639|NCT01115452|141681478|SUPERIORITY_OR_OTHER||Adjustes mean difference|1.88||||0.6591|TWO_SIDED|95.0|-6.52|10.28||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||10.28|-6.52|0.6591
71087640|NCT01115452|141681479|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.08||||0.6301||95.0|-10.6|6.45||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.45|-10.60|0.6301
71087641|NCT01115452|141681479|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.76||||0.6888|TWO_SIDED|95.0|-10.46|6.93||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.93|-10.46|0.6888
71124971|NCT03869333|141756204|OTHER|||||||0.335|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 8||||0.335
71124972|NCT03869333|141756204|OTHER|||||||0.229|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 29||||0.229
70857100|NCT02446743|141200511|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-31.0|||||TWO_SIDED|95.0|-46.0|-15.5|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-15.5|-46.0|
70857101|NCT02446743|141200511|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|3.0|||||TWO_SIDED|95.0|-10.8|18.8|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||18.8|-10.8|
70857102|NCT02446743|141200511|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month days after booster or 2nd dose)|vaccine group difference|22.0|||||TWO_SIDED|95.0|12.1|32.8|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||32.8|12.1|
70857103|NCT02446743|141200511|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-4.0|||||TWO_SIDED|95.0|-13.4|7.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||7.1|-13.4|
70857104|NCT02446743|141200511|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-3.2|8.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.5|-3.2|
70857105|NCT02446743|141200511|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|8.0|||||TWO_SIDED|95.0|4.2|13.2|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||13.2|4.2|
70857106|NCT02446743|141200511|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-15.1|16.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||16.1|-15.1|
70857107|NCT02446743|141200511|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-4.7|13.9|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||13.9|-4.7|
70857108|NCT02446743|141200511|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|12.0|||||TWO_SIDED|95.0|5.9|20.9|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||20.9|5.9|
71124973|NCT03869333|141756204|OTHER|||||||0.102|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 50||||0.102
71124974|NCT03869333|141756205|OTHER|||||||0.828|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 22.||||0.828
71124975|NCT03869333|141756205|OTHER|||||||0.629|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 43||||0.629
70945577|NCT02024750|141392214|OTHER||Mean Difference (Net)|0.134||||0.3|TWO_SIDED|95.0|-0.121|0.388||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the intervention period, the treatment effect on parent fear of hypoglycemia. Results reflect the difference in FOH trend between usual care and intervention arms.||0.388|-0.121|0.30
70945578|NCT02024750|141392214|OTHER||Mean Difference (Net)|-0.006||||0.98|TWO_SIDED|95.0|-0.384|0.373||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the post-intervention period, the treatment effect on parent fear of hypoglycemia. Results reflect the difference in FOH trend between usual care and intervention arms.||0.373|-0.384|0.98
70954326|NCT03843554|141411196|SUPERIORITY|IL5|Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|10.7||0.2991|TWO_SIDED|95.0|||||t-test, 2 sided|||The change in the inflammatory marker from baseline to the final intervention visit was analyzed using 95% confidence intervals and presented by treatment group. The two-sided t- test was used to compare the change in inflammatory markers between the two groups.||||0.2991
71124976|NCT03869333|141756205|OTHER||||||>|0.999|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 50||||>0.999
71124977|NCT03869333|141756205|OTHER||||||>|0.999|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 57||||>0.999
71124978|NCT03869333|141756205|OTHER|||||||0.825|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 71||||0.825
71124979|NCT03869333|141756206|OTHER|||||||0.005|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 22.||||0.005
71124980|NCT03869333|141756206|OTHER|||||||0.082|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 43||||0.082
71124981|NCT03869333|141756206|OTHER|||||||0.293|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 50||||0.293
71124982|NCT03869333|141756206|OTHER||||||>|0.999|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 57||||>0.999
71124983|NCT03869333|141756206|OTHER||||||>|0.999|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 71||||>0.999
71124984|NCT03869333|141756207|OTHER|||||||0.828|||||||Fisher Exact|||Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 8||||0.828
71124985|NCT03869333|141756207|OTHER|||||||0.913|||||||Fisher Exact|||Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 29||||0.913
71124986|NCT03869333|141756207|OTHER|||||||0.924|||||||Fisher Exact|||Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 50||||0.924
71124987|NCT03869333|141756208|OTHER||||||>|0.999|||||||Fisher Exact|||Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 8||||>0.999
71124988|NCT03869333|141756208|OTHER|||||||0.412|||||||Fisher Exact|||Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 29||||0.412
71124989|NCT03869333|141756208|OTHER|||||||0.847|||||||Fisher Exact|||Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 50||||0.847
71124990|NCT03869333|141756209|OTHER|||||||0.009|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 22||||0.009
71124991|NCT03869333|141756209|OTHER|||||||0.037|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 43||||0.037
71124992|NCT03869333|141756209|OTHER|||||||0.009|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 50||||0.009
71124993|NCT03869333|141756209|OTHER|||||||0.036|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 57||||0.036
71124994|NCT03869333|141756209|OTHER|||||||0.042|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 71||||0.042
71124995|NCT03869333|141756210|OTHER|||||||0.028|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 22||||0.028
71124996|NCT03869333|141756210|OTHER|||||||0.088|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 43||||0.088
71124997|NCT03869333|141756210|OTHER|||||||0.146|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 50||||0.146
71124998|NCT03869333|141756210|OTHER|||||||0.126|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 57||||0.126
71124999|NCT03869333|141756210|OTHER|||||||0.273|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 71||||0.273
71125000|NCT03869333|141756212|OTHER|||||||0.348|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 8||||0.348
71125001|NCT03869333|141756212|OTHER|||||||0.179|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 29||||0.179
71125002|NCT03869333|141756212|OTHER|||||||0.089|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 50||||0.089
71125003|NCT02598128|141756214|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|The independent variables in the mixed model analysis included fixed effect factors for treatment (placebo or RELiZORB).||||||<0.001
70945579|NCT00746356|141392222|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was calculated for an 80% power to reject the null hypothesis at 1.67% significance level.|Mean Difference (Final Values)|0.0066|STANDARD_DEVIATION|0.3103|<|0.0001|ONE_SIDED|95.0|-0.25|||P-value was adjusted for multiple efficacy endpoints. If all three primary effectiveness endpoints were met a value of 5% was used, if two were met a value of 2.5% was used, and if one was met a value of 1.67% was used.|t-test, 1 sided|If the data is not normally distributed, then the Wilcoxon signed rank test will be used to perform the two one-sided testing.||The null hypothesis was rejected at significance level 1.67% if the mean difference between the automatic test and the manual test was \<0.25 volts.|||-0.25|<0.0001
70945580|NCT00746356|141392223|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was calculated for an 80% power to reject the null hypothesis at 1.67% significance level.|Mean Difference (Final Values)|-0.0625|STANDARD_DEVIATION|0.0948||0.0001|ONE_SIDED|95.0|-0.25|||P-value was adjusted for multiple efficacy endpoints. If all three primary effectiveness endpoints were met a value of 5% was used, if two were met a value of 2.5% was used and if one was met a value of 1.67% was used.|t-test, 1 sided|If the data is not normally distributed, then the Wilcoxon signed rank test will be used to perform the two one-sided testing.||The null hypothesis was rejected at significance level 1.67% if the mean difference between the automatic test and the manual test was \<0.25 volts.|||-0.25|0.0001
70945581|NCT00746356|141392224|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was calculated for an 80% power to reject the null hypothesis at 1.67% significance level.|Mean Difference (Final Values)|-0.0556|STANDARD_DEVIATION|0.0824||0.0001|ONE_SIDED|95.0|-0.25|||P-value was adjusted for multiple efficacy endpoints. If all three primary effectiveness endpoints were met a value of 5% was used, if two were met, a value of 2.5% were used and if one was met a value of 1.67% was used.|t-test, 1 sided|If the data is not normally distributed, then the Wilcoxon signed rank test will be used to perform the two one-sided testing.||The null hypothesis was rejected at significance level 1.67% if the mean difference between the automatic test and the manual test was \<0.25 volts.|||-0.25|0.0001
70945582|NCT00746356|141392225|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was calculated for an 80% power to reject the null hypothesis at 1.67% significance level.|Mean Difference (Final Values)|0.0028|STANDARD_DEVIATION|0.2852||0.0001|ONE_SIDED|95.0|-0.25|||P-value was adjusted for multiple efficacy endpoints. If three primary effectiveness endpoints were met a value of 5% was used, if two were met a value of 2.5% was used and if one was met a value of 1.67% was used.|t-test, 1 sided|If the data is not normally distributed, then the Wilcoxon signed rank test will be used to perform the two one-sided testing.||The null hypothesis was rejected at significance level 1.67% if the mean difference between the automatic test and the manual test was \<0.25 volts.|||-0.25|0.0001
70945583|NCT03605368|141392231|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.13||0.23|TWO_SIDED||||||Regression, Linear|||Overall Behavior. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and BeSAFE).||||.23
70945584|NCT03605368|141392231|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.09||0.07|TWO_SIDED||||||Regression, Linear|||Appropriate Response. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and BeSAFE).||||.07
70945585|NCT03605368|141392231|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.99|TWO_SIDED||||||Regression, Linear|||Orienting. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and BeSAFE).||||.99
70945586|NCT03605368|141392231|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.16||0.005|TWO_SIDED||||||Regression, Linear|||Fidget. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and BeSAFE).||||.005
71087642|NCT01115452|141681479|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.32||||0.9428|TWO_SIDED|95.0|-8.37|9.0||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||9.00|-8.37|0.9428
71087643|NCT01115452|141681480|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.58||||0.5504|TWO_SIDED|95.0|-11.1|5.95||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||5.95|-11.10|0.5504
70945587|NCT03605368|141392231|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.11||0.01|TWO_SIDED||||||Regression, Linear|||Overall Behavior. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and TAU).||||.01
70945588|NCT03605368|141392231|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.09||0.04|TWO_SIDED||||||Regression, Linear|||Appropriate Response. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and TAU).||||.04
71125004|NCT00162266|141756225|SUPERIORITY_OR_OTHER||Point Estimate of Difference|25.6|||<|0.001|TWO_SIDED|95.0|12.8|38.4|||Chi-squared|||||38.4|12.8|<0.001
71125005|NCT00162266|141756225|SUPERIORITY_OR_OTHER||Point Estimate of Difference|6.6||||0.31|TWO_SIDED|95.0|-6.2|19.4|||Chi-squared|||||19.4|-6.2|0.31
71125006|NCT00162266|141756226|SUPERIORITY_OR_OTHER||Point Estimate of Difference|5.9||||0.283|TWO_SIDED|95.0|-4.9|16.7|||Chi-squared|||Response on Day 15||16.7|-4.9|0.283
70945589|NCT03605368|141392231|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.17||0.06|TWO_SIDED||||||Regression, Linear|||Appropriate Response. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and TAU).||||.06
70945590|NCT03605368|141392231|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.14||0.09|TWO_SIDED||||||Regression, Linear|||||||.09
70945591|NCT03605368|141392232|EQUIVALENCE|A linear regression compared change in Police Interaction Knowledge scores by group (Floreo vs. TAU) from pre- to post-intervention. Significance was set at p\<.05.|Mean Difference (Final Values)|1.62|STANDARD_ERROR_OF_MEAN|2.67||0.55|TWO_SIDED||||||Regression, Linear|||||||.55
70945592|NCT03605368|141392232|EQUIVALENCE|A linear regression compared change in Police Interaction Knowledge scores by group (Floreo vs. TAU) from pre- to post-intervention. Significance was set at p\<.05.|Mean Difference (Final Values)|5.42|STANDARD_ERROR_OF_MEAN|2.73||0.05|TWO_SIDED||||||Regression, Linear|||||||.05
70945593|NCT01125566|141392233|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.4224||95.0|0.87|1.41||Two sided p-value was derived from a log rank test stratified by the setting of prior Trastuzumab failure, hormone receptors status and region of the investigational site.|Regression, Cox||Hazard ratio is derived from Cox proportional hazard model stratified by prior Trastuzumab failure, hormone receptors status and region of the investigational site.|||1.41|0.87|0.4224
70945594|NCT01125566|141392234|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.024|TWO_SIDED|95.0|1.03|1.63||Two sided p-value from a log rank test stratified by the setting of prior Trastuzumab failure, hormone receptors status and region of the investigational site.|Regression, Cox||Hazard ratio is derived from Cox proportional hazard model stratified by prior Trastuzumab failure, hormone receptors status and region of the investigational site.|Results of presented analyses are to be seen as exploratory (no confirmatory testing was performed)||1.63|1.03|0.0240
70945595|NCT01125566|141392235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.6431||95.0|0.756|1.572|||Regression, Logistic|Logistic regression stratified by prior Trastuzumab failure, hormone receptors status and region of the investigational site.|The odds ratio for the comparison afatinib + vinorelbine vs. trastuzumab + vinorelbine below 1 favours Afatinib.|Results of presented analyses are to be seen as exploratory (no confirmatory testing was performed)||1.572|0.756|0.6431
70945596|NCT01125566|141392236|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.029||||0.8829||95.0|0.707|1.496|||Regression, Logistic|Logistic regression stratified by prior Trastuzumab failure, hormone receptors status and region of the investigational site.|The odds ratio for the comparison afatinib + vinorelbine vs. trastuzumab + vinorelbine below 1 favours AV.|Results of presented analyses are to be seen as exploratory (no confirmatory testing was performed)||1.496|0.707|0.8829
70945597|NCT03151551|141392237|SUPERIORITY||Rate Difference|8.1||||0.036|TWO_SIDED|95.0|0.5|15.8|||Regression, Logistic|||After data lock and initial analysis run, a medical inconsistency in baseline PASI data was identified (PASI=0 but BSA≥3%). The scenario was not anticipated or described in protocol or SAP. The inconsistency was resolved using medical judgment. The impacted participants had met baseline criteria for active psoriasis. Therefore, in the primary analysis, participants with baseline PASI=0 \& BSA≥3% were considered PASI100 responders if, and only if, PASI=0 \& BSA=0 achieved at week 24.||15.8|0.5|0.036
70945598|NCT03151551|141392238|NON_INFERIORITY|If the lower bound of the 2-sided 95% confidence Interval (CI) for the difference in proportions of responders on IXE minus ADA is greater than the pre-specified margin -12%, IXE will be deemed non-inferior to ADA.|Rate Difference|3.9|||||TWO_SIDED|95.0|-4.3|12.1||||||||12.1|-4.3|
70945599|NCT03151551|141392239|SUPERIORITY||Rate Difference|13.4||||0.001|TWO_SIDED|95.0|5.3|21.6|||Regression, Logistic|||After data lock and initial analysis run, a medical inconsistency in baseline PASI data was identified (PASI=0 but BSA≥3%). The scenario was not anticipated or described in protocol or SAP. The inconsistency was resolved using medical judgment. The impacted participants had met baseline criteria for active psoriasis. Therefore, in the primary analysis, participants with baseline PASI=0 \& BSA≥3% were considered PASI100 responders if, and only if, PASI=0 \& BSA=0 achieved at week 24.||21.6|5.3|0.001
70945600|NCT03151551|141392240|SUPERIORITY||Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|0.725||0.155|TWO_SIDED|95.0|-2.46|0.39|||Mixed Models Analysis|||||0.39|-2.46|0.155
70945601|NCT03151551|141392241|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.249||0.823|TWO_SIDED|95.0|-0.54|0.43|||Mixed Models Analysis|||||0.43|-0.54|0.823
70945602|NCT03151551|141392242|SUPERIORITY||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|2.104||0.752|TWO_SIDED|95.0|-4.8|3.47|||Mixed Models Analysis|||||3.47|-4.80|0.752
70945603|NCT03151551|141392243|SUPERIORITY||Mean Difference (Final Values)|-2.79|STANDARD_ERROR_OF_MEAN|2.06||0.177|TWO_SIDED|95.0|-6.83|1.26|||Mixed Models Analysis|||||1.26|-6.83|0.177
70945604|NCT03151551|141392244|SUPERIORITY||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|1.391||0.332|TWO_SIDED|95.0|-4.08|1.38|||Mixed Models Analysis|||||1.38|-4.08|0.332
70945605|NCT03151551|141392245|SUPERIORITY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.599||0.592|TWO_SIDED|95.0|-0.86|1.5|||Mixed Models Analysis|||||1.50|-0.86|0.592
70945606|NCT03151551|141392246|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.045||0.176|TWO_SIDED|95.0|-0.15|0.03|||Mixed Models Analysis|||||0.03|-0.15|0.176
70954327|NCT03843554|141411197|SUPERIORITY|OMDP-STANDARD|Mean Difference (Final Values)|-0.2293|STANDARD_ERROR_OF_MEAN|0.8555||0.2373|TWO_SIDED|95.0|-1.906|1.4475|||t-test, 2 sided|||||1.4475|-1.9060|0.2373
70945607|NCT03151551|141392247|SUPERIORITY||Rate Difference|13.1|||<|0.001|TWO_SIDED|95.0|5.4|20.7|||Regression, Logistic|||After data lock and initial analysis run, a medical inconsistency in baseline PASI data was identified (PASI=0 but BSA≥3%). The scenario was not anticipated or described in protocol or SAP. The inconsistency was resolved using medical judgment. The impacted participants had met baseline criteria for active psoriasis. Therefore, in the primary analysis, participants with baseline PASI=0 \& BSA≥3% were considered PASI100 responders if, and only if, PASI=0 \& BSA=0 achieved at week 52.||20.7|5.4|<0.001
70945608|NCT03151551|141392248|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.091||0.368|TWO_SIDED|95.0|-0.26|0.1|||Mixed Models Analysis|||||0.10|-0.26|0.368
70945609|NCT03151551|141392249|SUPERIORITY||Rate Difference|6.4||||0.108|TWO_SIDED|95.0|-1.8|14.5|||Regression, Logistic|||MDA-18 Entheseal Points||14.5|-1.8|0.108
70945610|NCT03151551|141392249|SUPERIORITY||Rate Difference|5.3||||0.179|TWO_SIDED|95.0|-2.9|13.5|||Regression, Logistic|||MDA-6 Entheseal Points||13.5|-2.9|0.179
70945611|NCT03151551|141392250|SUPERIORITY||Rate Difference|-1.1||||0.846|TWO_SIDED|95.0|-8.9|6.7|||Regression, Logistic|||||6.7|-8.9|0.846
70945612|NCT03151551|141392251|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.17||0.004|TWO_SIDED|95.0|-0.83|-0.16|||Mixed Models Analysis|||||-0.16|-0.83|0.004
70945613|NCT03151551|141392252|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.305||0.687|TWO_SIDED|95.0|-0.48|0.72|||Mixed Models Analysis|||||0.72|-0.48|0.687
70945614|NCT03151551|141392253|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.144||0.507|TWO_SIDED|95.0|-0.19|0.38|||Mixed Models Analysis|||||0.38|-0.19|0.507
70945615|NCT03151551|141392254|SUPERIORITY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|14.951||0.82|TWO_SIDED|95.0|-32.78|25.99|||Mixed Models Analysis|||||25.99|-32.78|0.820
70945616|NCT03151551|141392255|SUPERIORITY||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|0.79||0.052|TWO_SIDED|95.0|-3.09|0.02|||Mixed Models Analysis|||||0.02|-3.09|0.052
70945617|NCT03151551|141392256|SUPERIORITY||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.949||0.005|TWO_SIDED|95.0|-4.57|-0.84|||Mixed Models Analysis|||||-0.84|-4.57|0.005
71125007|NCT00162266|141756226|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-11.6||||0.015|TWO_SIDED|95.0|-20.9|-2.3|||Chi-squared|||Response on Day 15||-2.3|-20.9|0.015
70945618|NCT03151551|141392257|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.202||0.158|TWO_SIDED|95.0|-0.68|0.11|||Mixed Models Analysis|||||0.11|-0.68|0.158
70945619|NCT03151551|141392258|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.21||0.711|TWO_SIDED|95.0|-0.49|0.33|||Mixed Models Analysis|||||0.33|-0.49|0.711
70945620|NCT03151551|141392259|SUPERIORITY||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.674||0.439|TWO_SIDED|95.0|-0.8|1.85|||Mixed Models Analysis|||||1.85|-0.80|0.439
70945621|NCT03151551|141392260|SUPERIORITY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.86||0.594|TWO_SIDED|95.0|-1.23|2.15|||Mixed Models Analysis|||||2.15|-1.23|0.594
70945622|NCT03151551|141392261|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.017||0.979|TWO_SIDED|95.0|-0.03|0.03|||Mixed Models Analysis|||||0.03|-0.03|0.979
70945623|NCT03151551|141392262|SUPERIORITY||Mean Difference (Final Values)|4.78|STANDARD_ERROR_OF_MEAN|1.782||0.008|TWO_SIDED|95.0|1.28|8.28|||Mixed Models Analysis|||||8.28|1.28|0.008
70945624|NCT03151551|141392263|SUPERIORITY||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.335|<|0.001|TWO_SIDED|95.0|-1.78|-0.46|||Mixed Models Analysis|||||-0.46|-1.78|<0.001
70945625|NCT03151551|141392264|SUPERIORITY||Rate Difference|5.7||||0.165|TWO_SIDED|95.0|-2.4|13.7|||Regression, Logistic|||Effectiveness of Medication||13.7|-2.4|0.165
70945626|NCT03151551|141392264|SUPERIORITY||Rate Difference|6.7||||0.098|TWO_SIDED|95.0|-1.4|14.8|||Regression, Logistic|||Effectiveness over Time of Medication||14.8|-1.4|0.098
70945627|NCT03151551|141392264|SUPERIORITY||Rate Difference|4.6||||0.241|TWO_SIDED|95.0|-3.4|12.6|||Regression, Logistic|||Long Term Safety of Medication||12.6|-3.4|0.241
70945628|NCT03151551|141392264|SUPERIORITY||Rate Difference|4.9||||0.215|TWO_SIDED|95.0|-3.1|13.0|||Regression, Logistic|||Overall Satisfaction with Medication||13.0|-3.1|0.215
70945629|NCT03151551|141392264|SUPERIORITY||Rate Difference|2.1||||0.561|TWO_SIDED|95.0|-5.5|9.7|||Regression, Logistic|||Mostly Satisfied to any Questions||9.7|-5.5|0.561
70945630|NCT02979613|141392269|NON_INFERIORITY|Non-inferiority was assessed using a 95% confidence interval (CI) approach, with a non-inferiority margin of 4%.|Difference in the Percentages|0.0|||||TWO_SIDED|95.0|-1.9|2.0|||||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted Mantel-Haenszel (MH) percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|The null hypothesis was that the TAF group is at least 4% worse than the TDF group with respect to the percentage of participants with HBV DNA ≥ 20 IU/mL at Week 48. The alternative hypothesis was that the TAF group is less than 4% worse than the TDF group with respect to the percentage of participants with HBV DNA ≥ 20 IU/mL at Week 48.||2.0|-1.9|
71125008|NCT00162266|141756226|SUPERIORITY_OR_OTHER||Point Estimate of Difference|11.5||||0.067|TWO_SIDED|95.0|-0.8|23.8|||Chi-squared|||Response on Day 30||23.8|-0.8|0.067
71125009|NCT00162266|141756226|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-9.3||||0.113|TWO_SIDED|95.0|-20.8|2.2|||Chi-squared|||Response on Day 30||2.2|-20.8|0.113
71125010|NCT00162266|141756226|SUPERIORITY_OR_OTHER||Point Estimate of Difference|22.1|||<|0.001|TWO_SIDED|95.0|9.3|34.8|||Chi-squared|||Response on Day 60||34.8|9.3|<0.001
70945631|NCT02979613|141392270|NON_INFERIORITY|Non-inferiority was assessed using a 95% confidence interval (CI) approach, with a non-inferiority margin of 4%.|Difference in the Percentages|0.0|||||TWO_SIDED|95.0|-1.9|1.9|||||Difference in the percentage of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|||1.9|-1.9|
70945632|NCT02979613|141392270|SUPERIORITY|||||||0.9953||||||P-value for the superiority tests compared the percentage of each HBV DNA outcome was from CMH tests stratified by baseline age groups and baseline HBeAg status strata.|Cochran-Mantel-Haenszel|||||||0.9953
70945633|NCT02979613|141392271|NON_INFERIORITY|Non-inferiority was assessed using a 95% CI approach, with a non-inferiority margin of 4%.|Difference in the Percentages|0.0|||||TWO_SIDED|95.0|-3.7|3.7|||||Difference in the percentage of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|||3.7|-3.7|
70945634|NCT02979613|141392271|SUPERIORITY|||||||0.98||||||P-value for the superiority tests compared the percentage of each HBV DNA outcome was from CMH tests stratified by baseline age groups and baseline HBeAg status strata.|Cochran-Mantel-Haenszel|||||||0.98
70945635|NCT02979613|141392273|NON_INFERIORITY|Non-inferiority was assessed using a 95% confidence interval (CI) approach, with a non-inferiority margin of 4%.|Difference in the Percentages|0.9|||||TWO_SIDED|95.0|-3.5|5.2|||||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|||5.2|-3.5|
70945636|NCT02979613|141392273|SUPERIORITY|||||||0.6863||||||P-value for the superiority tests compared the percentage of each HBV DNA outcome was from CMH tests stratified by baseline age groups and baseline HBeAg status strata.|Cochran-Mantel-Haenszel|||||||0.6863
70945637|NCT02979613|141392275|SUPERIORITY||Difference in the Percentages|1.4||||0.7258|TWO_SIDED|95.0|-7.2|10.1||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years).|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups.|||10.1|-7.2|0.7258
70945638|NCT02979613|141392276|SUPERIORITY||Difference in the Percentages|2.7||||0.1348|TWO_SIDED|95.0|-2.3|7.7||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years).|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups.|||7.7|-2.3|0.1348
70945639|NCT02979613|141392277|SUPERIORITY||Difference in the Percentages|9.0||||0.1005|TWO_SIDED|95.0|-2.0|20.1||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years).|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups.|||20.1|-2.0|0.1005
70945640|NCT02979613|141392278|SUPERIORITY||Difference in the Percentages|2.5||||0.4154|TWO_SIDED|95.0|-4.5|9.5||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years).|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups.|||9.5|-4.5|0.4154
70945641|NCT02979613|141392279|SUPERIORITY||Difference in the Percentages|-2.0||||0.0281|TWO_SIDED|95.0|-4.4|0.3||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|||0.3|-4.4|0.0281
71125011|NCT00162266|141756226|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-1.1||||0.86|TWO_SIDED|95.0|-13.5|11.3|||Chi-squared|||Response on Day 60||11.3|-13.5|0.86
71125012|NCT00162266|141756226|SUPERIORITY_OR_OTHER||Point Estimate of Difference|18.6||||0.004|TWO_SIDED|95.0|5.9|31.4|||Chi-squared|||Response on Day 90||31.4|5.9|0.004
71125013|NCT00162266|141756226|SUPERIORITY_OR_OTHER||Point Estimate of Difference|2.8||||0.664|TWO_SIDED|95.0|-9.8|15.4|||Chi-squared|||Response on Day 90||15.4|-9.8|0.664
71125014|NCT00162266|141756226|SUPERIORITY_OR_OTHER||Point Estimate of Difference|23.9|||<|0.001|TWO_SIDED|95.0|11.1|36.7|||Chi-squared|||Response on Day 120||36.7|11.1|<0.001
71125015|NCT00162266|141756226|SUPERIORITY_OR_OTHER||Point Estimate of Difference|6.9||||0.292|TWO_SIDED|95.0|-6.0|19.9|||Chi-squared|||Response on Day 120||19.9|-6.0|0.292
71125016|NCT00162266|141756226|SUPERIORITY_OR_OTHER||Point Estimate of Difference|23.0|||<|0.001|TWO_SIDED|95.0|10.2|35.8|||Chi-squared|||Response on Day 150||35.8|10.2|<0.001
71125017|NCT00162266|141756226|SUPERIORITY_OR_OTHER||Point Estimate of Difference|8.5||||0.193|TWO_SIDED|95.0|-4.3|21.3|||Chi-squared|||Response on Day 150||21.3|-4.3|0.193
71125018|NCT00162266|141756226|SUPERIORITY_OR_OTHER||Point Estimate of Difference|25.6|||<|0.001|TWO_SIDED|95.0|12.8|38.4|||Chi-squared|||Response on Day 180||38.4|12.8|<0.001
71125019|NCT00162266|141756226|SUPERIORITY_OR_OTHER||Point Estimate of Difference|6.6||||0.31||95.0|-6.2|19.4|||Chi-squared|||Response on Day 180||19.4|-6.2|0.31
71125020|NCT00162266|141756226|SUPERIORITY_OR_OTHER||Point Estimate of Difference|27.3|||<|0.001|TWO_SIDED|95.0|14.5|40.1|||Chi-squared|||Response on Day 240||40.1|14.5|<0.001
71125021|NCT00162266|141756226|SUPERIORITY_OR_OTHER||Point Estimate of Difference|5.7||||0.384|TWO_SIDED|95.0|-7.1|18.4|||Chi-squared|||Response on Day 240||18.4|-7.1|0.384
71125022|NCT00162266|141756226|SUPERIORITY_OR_OTHER||Point Estimate of Difference|29.0|||<|0.001|TWO_SIDED|95.0|16.2|41.8|||Chi-squared|||Response on Day 300||41.8|16.2|<0.001
71125023|NCT00162266|141756226|SUPERIORITY_OR_OTHER||Point Estimate of Difference|4.6||||0.476|TWO_SIDED|95.0|-8.0|17.2|||Chi-squared|||Response on Day 300||17.2|-8.0|0.476
71125024|NCT00162266|141756226|SUPERIORITY_OR_OTHER||Point Estimate of Difference|26.5|||<|0.001|TWO_SIDED|95.0|13.7|39.3|||Chi-squared|||Response on Day 360||39.3|13.7|<0.001
71125025|NCT00162266|141756226|SUPERIORITY_OR_OTHER||Point Estimate of Difference|5.8||||0.377|TWO_SIDED|95.0|-7.0|18.6|||Chi-squared|||Response on Day 360||18.6|-7.0|0.377
71125026|NCT00162266|141756227|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-0.8||||0.679|TWO_SIDED|95.0|-4.5|2.9|||Chi-squared|||Response on Day 15||2.9|-4.5|0.679
71125027|NCT00162266|141756227|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-2.5||||0.101|TWO_SIDED|95.0|-5.5|0.5|||Chi-squared|||Response on Day 15||0.5|-5.5|0.101
71125028|NCT00162266|141756227|SUPERIORITY_OR_OTHER||Point Estimate of Difference|8.0||||0.039|TWO_SIDED|95.0|0.4|15.7|||Chi-squared|||Response on Day 30||15.7|0.4|0.039
71125029|NCT00162266|141756227|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-2.1||||0.474|TWO_SIDED|95.0|-7.7|3.6|||Chi-squared|||Response on Day 30||3.6|-7.7|0.474
71125030|NCT00162266|141756227|SUPERIORITY_OR_OTHER||Point Estimate of Difference|6.6||||0.192|TWO_SIDED|95.0|-3.3|16.5|||Chi-squared|||Response on Day 60||16.5|-3.3|0.192
71125031|NCT00162266|141756227|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-1.8||||0.702|TWO_SIDED|95.0|-11.0|7.4|||Chi-squared|||Response on Day 60||7.4|-11.0|0.702
71125032|NCT00162266|141756227|SUPERIORITY_OR_OTHER||Point Estimate of Difference|11.7||||0.02|TWO_SIDED|95.0|1.8|21.7|||Chi-squared|||Response on Day 90||21.7|1.8|0.02
71125033|NCT00162266|141756227|SUPERIORITY_OR_OTHER||Point Estimate of Difference|4.5||||0.339|TWO_SIDED|95.0|-4.8|13.8|||Chi-squared|||Response on Day 90||13.8|-4.8|0.339
71125034|NCT00162266|141756227|SUPERIORITY_OR_OTHER||Point Estimate of Difference|17.9||||0.001|TWO_SIDED|95.0|7.0|28.9|||Chi-squared|||Response on Day 120||28.9|7.0|0.001
71125035|NCT00162266|141756227|SUPERIORITY_OR_OTHER||Point Estimate of Difference|2.0||||0.682|TWO_SIDED|95.0|-7.6|11.7|||Chi-squared|||Response on Day 120||11.7|-7.6|0.682
71125036|NCT00162266|141756227|SUPERIORITY_OR_OTHER||Point Estimate of Difference|20.6|||<|0.001|TWO_SIDED|95.0|9.3|31.8|||Chi-squared|||Response on Day 150||31.8|9.3|<0.001
71125037|NCT00162266|141756227|SUPERIORITY_OR_OTHER||Point Estimate of Difference|1.2||||0.813|TWO_SIDED|95.0|-8.6|10.9|||Chi-squared|||Response on Day 150||10.9|-8.6|0.813
71125038|NCT00162266|141756227|SUPERIORITY_OR_OTHER||Point Estimate of Difference|24.8|||<|0.001|TWO_SIDED|95.0|13.8|35.7|||Chi-squared|||Response on Day 180||35.7|13.8|<0.001
71125039|NCT00162266|141756227|SUPERIORITY_OR_OTHER||Point Estimate of Difference|11.1||||0.027|TWO_SIDED|95.0|1.2|20.9|||Chi-squared|||Response on Day 180||20.9|1.2|0.027
70857109|NCT02446743|141200511|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-5.0|||||TWO_SIDED|95.0|-16.7|8.6|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||8.6|-16.7|
70857110|NCT02446743|141200511|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-5.7|11.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||11.1|-5.7|
71125040|NCT00162266|141756227|SUPERIORITY_OR_OTHER||Point Estimate of Difference|15.5||||0.008|TWO_SIDED|95.0|4.0|27.0|||Chi-squared|||Response on Day 240||27.0|4.0|0.008
71125041|NCT00162266|141756227|SUPERIORITY_OR_OTHER||Point Estimate of Difference|0.8||||0.885|TWO_SIDED|95.0|-9.8|11.4|||Chi-squared|||Response on Day 240||11.4|-9.8|0.885
71125042|NCT00162266|141756227|SUPERIORITY_OR_OTHER||Point Estimate of Difference|24.0|||<|0.001|TWO_SIDED|95.0|12.6|35.4|||Chi-squared|||Response on Day 300||35.4|12.6|<0.001
71125043|NCT00162266|141756227|SUPERIORITY_OR_OTHER||Point Estimate of Difference|6.8||||0.19|TWO_SIDED|95.0|-3.4|16.9|||Chi-squared|||Response on Day 300||16.9|-3.4|0.19
71125044|NCT00162266|141756227|SUPERIORITY_OR_OTHER||Point Estimate of Difference|21.6|||<|0.001|TWO_SIDED|95.0|9.7|33.4|||Chi-squared|||Response on Day 360||33.4|9.7|<0.001
71125045|NCT00162266|141756227|SUPERIORITY_OR_OTHER||Point Estimate of Difference|2.7||||0.625|TWO_SIDED|95.0|-8.1|13.5|||Chi-squared|||Response on Day 360||13.5|-8.1|0.625
71125046|NCT00162266|141756228|SUPERIORITY_OR_OTHER||Point Estimate of Difference|3.5||||0.04||95.0|0.2|6.8|||Chi-squared|||Response on Day 30||6.8|0.2|0.04
71125047|NCT00162266|141756228|SUPERIORITY_OR_OTHER||Point Estimate of Difference|2.9||||0.063|TWO_SIDED|95.0|-0.2|5.9|||Chi-squared|||Response on Day 30||5.9|-0.2|0.063
71125048|NCT00162266|141756228|SUPERIORITY_OR_OTHER||Point Estimate of Difference|8.7||||0.001|TWO_SIDED|95.0|3.5|13.9|||Chi-squared|||Response on Day 60||13.9|3.5|0.001
71125049|NCT00162266|141756228|SUPERIORITY_OR_OTHER||Point Estimate of Difference|3.8||||0.032|TWO_SIDED|95.0|0.3|7.3|||Chi-squared|||Response on Day 60||7.3|0.3|0.032
71125050|NCT00162266|141756228|SUPERIORITY_OR_OTHER||Point Estimate of Difference|7.9||||0.005|TWO_SIDED|95.0|2.4|13.3|||Chi-squared|||Response on Day 90||13.3|2.4|0.005
71125051|NCT00162266|141756228|SUPERIORITY_OR_OTHER||Point Estimate of Difference|3.9||||0.07|TWO_SIDED|95.0|-0.3|8.2|||Chi-squared|||Response on Day 90||8.2|-0.3|0.07
71125052|NCT00162266|141756228|SUPERIORITY_OR_OTHER||Point Estimate of Difference|9.7||||0.007|TWO_SIDED|95.0|2.7|16.7|||Chi-squared|||Response on Day 120||16.7|2.7|0.007
71125053|NCT00162266|141756228|SUPERIORITY_OR_OTHER||Point Estimate of Difference|2.4||||0.395||95.0|-3.1|7.8|||Chi-squared|||||7.8|-3.1|0.395
71125054|NCT00162266|141756228|SUPERIORITY_OR_OTHER||Point Estimate of Difference|10.6||||0.004|TWO_SIDED|95.0|3.4|17.7|||Chi-squared|||Response on Day 150||17.7|3.4|0.004
71125055|NCT00162266|141756228|SUPERIORITY_OR_OTHER||Point Estimate of Difference|2.4||||0.395|TWO_SIDED|95.0|-3.1|7.8|||Chi-squared|||Response on Day 150||7.8|-3.1|0.395
71125056|NCT00162266|141756228|SUPERIORITY_OR_OTHER||Point Estimate of Difference|14.8|||<|0.001|TWO_SIDED|95.0|7.5|22.2|||Chi-squared|||Response on Day 180||22.2|7.5|<0.001
71125057|NCT00162266|141756228|SUPERIORITY_OR_OTHER||Point Estimate of Difference|8.8||||0.005|TWO_SIDED|95.0|2.7|14.9|||Chi-squared|||Response on Day 180||14.9|2.7|0.005
71125058|NCT00162266|141756228|SUPERIORITY_OR_OTHER||Point Estimate of Difference|13.2||||0.002|TWO_SIDED|95.0|5.0|21.4|||Chi-squared|||Response on Day 240||21.4|5.0|0.002
71125059|NCT00162266|141756228|SUPERIORITY_OR_OTHER||Point Estimate of Difference|3.5||||0.292|TWO_SIDED|95.0|-3.0|10.1|||Chi-squared|||Response on Day 240||10.1|-3.0|0.292
71125060|NCT00162266|141756228|SUPERIORITY_OR_OTHER||Point Estimate of Difference|21.0|||<|0.001|TWO_SIDED|95.0|12.4|29.5|||Chi-squared|||Response on Day 300||29.5|12.4|<0.001
71125061|NCT00162266|141756228|SUPERIORITY_OR_OTHER||Point Estimate of Difference|8.0||||0.014|TWO_SIDED|95.0|1.6|14.3|||Chi-squared|||Response on Day 300||14.3|1.6|0.014
70857111|NCT02446743|141200511|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|5.0|||||TWO_SIDED|95.0|-0.7|11.1||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||11.1|-0.7|
70857112|NCT02446743|141200512|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-30.0|||||TWO_SIDED|95.0|-40.4|-19.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-19.0|-40.4|
71125062|NCT00162266|141756228|SUPERIORITY_OR_OTHER||Point Estimate of Difference|13.3||||0.003|TWO_SIDED|95.0|4.4|22.2|||Chi-squared|||Response on Day 360||22.2|4.4|0.003
71125063|NCT00162266|141756228|SUPERIORITY_OR_OTHER||Point Estimate of Difference|4.8||||0.227|TWO_SIDED|95.0|-3.0|12.6|||Chi-squared|||Response on Day 360||12.6|-3.0|0.227
71125064|NCT00162266|141756229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.02||||0.2676|TWO_SIDED|95.0|-1.56|5.61|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 15 Treatment Comparison||5.61|-1.56|0.2676
71125065|NCT00162266|141756229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8||||0.0418|TWO_SIDED|95.0|-7.46|-0.14|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 15 Treatment Comparison||-0.14|-7.46|0.0418
71125066|NCT00162266|141756229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.25||||0.0061|TWO_SIDED|95.0|2.08|12.41|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 30 Treatment Comparison||12.41|2.08|0.0061
70857113|NCT02446743|141200512|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|3.0|||||TWO_SIDED|95.0|-2.6|10.3|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||10.3|-2.6|
70857114|NCT02446743|141200512|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|8.0|||||TWO_SIDED|95.0|3.9|12.5|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||12.5|3.9|
71125067|NCT00162266|141756229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14||||0.6713|TWO_SIDED|95.0|-6.45|4.16||ANOVA model: AUC = treatment|ANOVA||Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 30 Treatment Comparison||4.16|-6.45|0.6713
71125068|NCT00162266|141756229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.75||||0.0002|TWO_SIDED|95.0|5.67|17.84|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 60 Treatment Comparison||17.84|5.67|0.0002
71125069|NCT00162266|141756229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.8495|TWO_SIDED|95.0|-5.62|6.82|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 60 Treatment Comparison||6.82|-5.62|0.8495
71125070|NCT00162266|141756229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.1||||0.0003|TWO_SIDED|95.0|5.63|18.56|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 90 Treatment Comparison||18.56|5.63|0.0003
71125071|NCT00162266|141756229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.19||||0.0003|TWO_SIDED|95.0|-2.44|10.81|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 90 Treatment Comparison||10.81|-2.44|0.0003
71125072|NCT00162266|141756229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.54||||0.0001|TWO_SIDED|95.0|7.28|21.81|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 120 Treatment Comparison||21.81|7.28|0.0001
71125073|NCT00162266|141756229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6||||0.3141|TWO_SIDED|95.0|-3.43|10.64|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 120 Treatment Comparison||10.64|-3.43|0.3141
71125074|NCT00162266|141756229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.96||||0.0001|TWO_SIDED|95.0|8.49|25.43|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 150 Treatment Comparison||25.43|8.49|0.0001
71125075|NCT00162266|141756229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.32||||0.3552|TWO_SIDED|95.0|-3.73|10.37|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 150 Treatment Comparison||10.37|-3.73|0.3552
71125076|NCT00162266|141756229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.36||||0.0001|TWO_SIDED|95.0|10.19|30.54|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 180 Treatment Comparison||30.54|10.19|0.0001
71125077|NCT00162266|141756229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.38||||0.0451|TWO_SIDED|95.0|0.16|14.6|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 180 Treatment Comparison||14.60|0.16|0.0451
71125078|NCT00162266|141756229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.63||||0.0001|TWO_SIDED|95.0|8.83|26.44|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 240 Treatment Comparison||26.44|8.83|0.0001
71125079|NCT00162266|141756229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.78||||0.4669|TWO_SIDED|95.0|-4.73|10.28|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 240 Treatment Comparison||10.28|-4.73|0.4669
71125080|NCT00162266|141756229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.0||||0.0001|TWO_SIDED|95.0|10.51|31.48|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 300 Treatment Comparison||31.48|10.51|0.0001
71125081|NCT00162266|141756229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.13||||3.13|TWO_SIDED|95.0|-4.15|10.41|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 300 Treatment Comparison||10.41|-4.15|3.13
71125082|NCT00162266|141756229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.38||||0.0001|TWO_SIDED|95.0|10.2|30.56|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 360 Treatment Comparison||30.56|10.20|0.0001
71125083|NCT00162266|141756229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.06||||0.2989|TWO_SIDED|95.0|-3.61|11.72|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 360 Treatment Comparison||11.72|-3.61|0.2989
71125084|NCT00162266|141756230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2132.63||||0.0001|TWO_SIDED|95.0|1067.32|3197.94||ANOVA model: AUC = treatment|ANOVA||Estimate = Model AUC for Aripiprazole+MTX - Model AUC for PLACEBO+MTX|Comparison at Day 180||3197.94|1067.32|0.0001
71125085|NCT00162266|141756230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|353.47||||0.4393|TWO_SIDED|95.0|-544.46|1251.41||ANOVA model: AUC = treatment|ANOVA||Estimate = Model AUC for Aripiprazole+MTX - Model AUC for PLACEBO+MTX|Comparison at Day 180||1251.41|-544.46|0.4393
71125086|NCT00162266|141756230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5641.6||||0.0001|TWO_SIDED|95.0|2823.46|8459.74||ANOVA model: AUC = treatment|ANOVA||Estimate = Model AUC for Aripiprazole+MTX - Model AUC for PLACEBO+MTX|Comparison at Day 360||8459.74|2823.46|0.0001
71125087|NCT00162266|141756230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1054.38||||0.3029|TWO_SIDED|95.0|-955.59|3064.35||ANOVA model: AUC = treatment|ANOVA||Estimate = Model AUC for Aripiprazole+MTX - Model AUC for PLACEBO+MTX|Comparison at Day 360||3064.35|-955.59|0.3029
71125088|NCT00162266|141756234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.66||||0.0003|TWO_SIDED|95.0|12.67|42.66|||ANCOVA|ANCOVA: % change = pretreatment|Estimate = adjusted % change (BMS10mg/kg+MTX or BMS 2mg/kg+MTX) - adjusted change for placebo+MTX|Day 180||42.66|12.67|0.0003
71125089|NCT00162266|141756234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.68||||0.3253|TWO_SIDED|95.0|||||ANCOVA|ANCOVA model: % change = pretreatment|Estimate = adjusted % change (BMS10mg/kg+MTX or BMS 2mg/kg+MTX) - adjusted change for placebo+MTX|Day 180||||0.3253
71125090|NCT00162266|141756234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.24||||0.0001|TWO_SIDED|95.0|16.14|48.33|||ANCOVA|ANCOVA model: % change = pretreatment|Estimate = adjusted % change (BMS10mg/kg+MTX or BMS 2mg/kg+MTX) - adjusted change for placebo+MTX|Day 360||48.33|16.14|0.0001
71125091|NCT00162266|141756234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.48||||0.0869|TWO_SIDED|95.0|-1.82|26.78|||ANCOVA|ANCOVA model: % change = pretreatment|Estimate = adjusted % change (BMS10mg/kg+MTX or BMS 2mg/kg+MTX) - adjusted change for placebo+MTX|Day 360||26.78|-1.82|0.0869
71125092|NCT03480009|141756309|OTHER|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||.20
71125093|NCT03480009|141756309|OTHER|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||.20
71125094|NCT03480009|141756310|OTHER|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Ibuprofen||||.81
71125095|NCT03480009|141756310|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||acetaminophen||||.24
71125096|NCT03480009|141756310|OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||oxycodone||||.54
71125097|NCT03480009|141756310|OTHER|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||Ibuprofen||||.61
71125098|NCT03480009|141756310|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Acetaminophen||||.24
71125099|NCT03480009|141756311|OTHER|||||||0.99|||||||Wald Chi Square|Wald Chi Square from mixed effects linear regression||||||.99
71125100|NCT03480009|141756311|OTHER|||||||0.56|||||||Wald Chi Square|P-value from Wald chi-square from mixed effects linear regression||||||.56
71125101|NCT03480009|141756312|OTHER|||||||0.07|||||||Fisher Exact|||||||.07
71125102|NCT03480009|141756312|OTHER|||||||0.5|||||||Fisher Exact|||||||.50
71125103|NCT00752726|141756339|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.263|STANDARD_ERROR_OF_MEAN|0.115||0.0244|TWO_SIDED|95.0|0.035|0.491||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean change was adjusted for treatment, baseline VAT and center effect using an ANCOVA model.|Adjusted mean difference between Placebo group and Orlistat group was determined. For this primary analysis, only one statistical test was performed and therefore, no multiple comparison adjustment was done.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||0.491|0.035|0.0244
71125104|NCT00752726|141756340|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.172|STANDARD_ERROR_OF_MEAN|0.0834||0.0415|TWO_SIDED|95.0|0.007|0.337||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean change was adjusted for the treatment, baseline VAT and center effects using an ANCOVA model.|Adjusted mean difference between Placebo group and Orlistat group was determined.|The null hypothesis considered no difference in the change from baseline to week 12 between the two treatment groups.||0.337|0.007|0.0415
70945642|NCT02979613|141392281|SUPERIORITY||Difference in the Percentages|-0.8||||0.5373|TWO_SIDED|95.0|-3.7|2.1||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|||2.1|-3.7|0.5373
70945643|NCT02979613|141392282|SUPERIORITY||Difference in the Percentages|0.4||||0.5845|TWO_SIDED|95.0|-1.7|2.5||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|||2.5|-1.7|0.5845
70945644|NCT02979613|141392283|SUPERIORITY||Difference in the Percentages|4.5||||0.1405|TWO_SIDED|95.0|-1.6|10.6||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Central Laboratory Criteria||10.6|-1.6|0.1405
70945645|NCT02979613|141392283|SUPERIORITY||Difference in the Percentages|3.8||||0.3133|TWO_SIDED|95.0|-3.7|11.4||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|AASLD Criteria||11.4|-3.7|0.3133
70945646|NCT02979613|141392284|SUPERIORITY||Difference in the Percentages|14.1||||0.3381|TWO_SIDED|95.0|-16.4|44.6||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Central Laboratory criteria||44.6|-16.4|0.3381
70945647|NCT02979613|141392284|SUPERIORITY||Difference in the Percentages|23.8||||0.0136|TWO_SIDED|95.0|5.3|42.3||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|AASLD Criteria||42.3|5.3|0.0136
70945648|NCT02979613|141392285|SUPERIORITY||Difference in the Percentages|-2.9||||0.2803|TWO_SIDED|95.0|-8.4|2.6||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Central Laboratory Criteria||2.6|-8.4|0.2803
70945649|NCT02979613|141392285|SUPERIORITY||Difference in the Percentages|-5.9||||0.0788|TWO_SIDED|95.0|-12.6|0.7||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|AASLD Criteria||0.7|-12.6|0.0788
70945650|NCT02979613|141392286|SUPERIORITY||Difference in the Percentages|-23.9||||0.088|TWO_SIDED|95.0|-51.2|3.4||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Central Laboratory Criteria||3.4|-51.2|0.0880
70945651|NCT02979613|141392286|SUPERIORITY||Difference in the Percentages|-18.6||||0.051|TWO_SIDED|95.0|-37.4|0.2||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|AASLD Criteria||0.2|-37.4|0.0510
70945652|NCT02979613|141392287|SUPERIORITY||Difference in LSM|-0.02||||0.0186|TWO_SIDED|95.0|-0.03|0.0|||ANOVA|||P-value, difference in least squares mean (LSM), and its 95% CI were derived from analysis of variance (ANOVA) model with baseline age groups (\< 50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.||0.00|-0.03|0.0186
71125105|NCT00752726|141756341|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.99|STANDARD_ERROR_OF_MEAN|0.881||0.026|TWO_SIDED|95.0|0.25|3.74||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean change was adjusted for the treatment, baseline weight and center effects, using an ANCOVA model.|Adjusted mean difference between Placebo group and Orlistat group was determined.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||3.74|0.25|0.026
71125106|NCT00752726|141756342|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.642|STANDARD_ERROR_OF_MEAN|0.7174||0.0242|TWO_SIDED|95.0|0.219|3.065||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean change was adjusted for the treatment, baseline total fat mass and center effects using an ANCOVA model.|Adjusted mean difference between placebo group and Orlistat group was determined.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||3.065|0.219|0.0242
71125107|NCT00752726|141756343|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.47|STANDARD_ERROR_OF_MEAN|0.704||0.039|TWO_SIDED|95.0|0.07|2.87||P-value was not adjusted for multiple comparisons|ANCOVA|Mean was adjusted for the treatment, baseline total fat mass and center effects using an ANCOVA model.|Adjusted mean difference between placebo group and Orlistat group was evaluated.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||2.87|0.07|0.039
70945653|NCT02979613|141392288|SUPERIORITY||Difference in LSM|0.0||||0.6956|TWO_SIDED|95.0|-0.02|0.01|||ANOVA|||P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (\<50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.||0.01|-0.02|0.6956
70945654|NCT02979613|141392289|SUPERIORITY||Difference in LSM|1.167|||<|0.0001|TWO_SIDED|95.0|0.797|1.536|||ANOVA|||P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (\<50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.||1.536|0.797|< 0.0001
70945655|NCT02979613|141392290|SUPERIORITY||Difference in LSM|0.977||||0.0002|TWO_SIDED|95.0|0.465|1.49|||ANOVA|||P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (\<50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.||1.490|0.465|0.0002
70945656|NCT02979613|141392291|SUPERIORITY||Difference in LSM|1.881|||<|0.0001|TWO_SIDED|95.0|1.275|2.486|||ANOVA|||P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (\<50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.||2.486|1.275|< 0.0001
70945657|NCT02979613|141392292|SUPERIORITY||Difference in LSM|0.604||||0.097|TWO_SIDED|95.0|-0.11|1.317|||ANOVA|||P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (\<50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.||1.317|-0.110|0.0970
70945658|NCT02979613|141392293|SUPERIORITY||||||<|0.0001||||||P-values were from the 2-sided Wilcoxon rank sum test to compare the 2 treatment groups.|Wilcoxon rank sum test|||||||< 0.0001
70945659|NCT02979613|141392294|SUPERIORITY|||||||0.7535||||||P-values were from the 2-sided Wilcoxon rank sum test to compare the 2 treatment groups.|Wilcoxon rank sum test|||||||0.7535
70945660|NCT02250183|141392311|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|||||A priori threshold for statistical significance was p\<0.05. Each case (participant) serves as its own control because they received both treatment modalities simultaneously.|McNemar|McNemar test was used because participants received both treatments, so this variable was non-independent in our single group sample.|2-sided|Each participant received both treatment modalities - MEDIHONEY® and SANTYL - and thus had two wound cultures performed, one for each treatment modality. This was a single group study; however, wound culture results were contrasted with each other across participants. Thus, independent variable was treatment modality, while dependent variable was the wound culture result (positive for presence of bacteria versus negative for absence of bacteria).||||1.00
70945661|NCT02250183|141392312|SUPERIORITY||Mean Difference (Final Values)|3.615|STANDARD_ERROR_OF_MEAN|0.79||0.003|TWO_SIDED|95.0|1.149|4.565||The null hypothesis was that the two mean scores would not differ significantly at p\<.05 level.|t-test, 2 sided|df = 13||A paired samples, 2-tailed, t-test was used to compare means within participants for ratings of MEDIHONEY and SANTYL satisfaction total scores. The null hypothesis was that the two mean scores would not differ significantly at p\<.05 level.||4.565|1.149|.003
70945662|NCT03282799|141392314|OTHER||||||<|0.001|||||||Fisher Exact|||||||<.001
70945663|NCT03282799|141392315|OTHER||||||<|0.001|||||||Fisher Exact|||||||<.001
70945664|NCT03282799|141392316|OTHER||||||<|0.001|||||||Fisher Exact|||||||<.001
70945665|NCT03282799|141392317|OTHER||||||>|0.99|||||||Fisher Exact|||||||>.99
70945666|NCT03282799|141392318|OTHER|||||||0.685|||||||Wilcoxon (Mann-Whitney)|||||||.685
70945667|NCT03282799|141392319|OTHER|||||||0.784|||||||Wilcoxon (Mann-Whitney)|||||||.784
70945668|NCT03282799|141392320|OTHER|||||||0.587|||||||Wilcoxon (Mann-Whitney)|||||||.587
70945669|NCT03282799|141392321|OTHER|||||||0.394|||||||Wilcoxon (Mann-Whitney)|||||||.394
70945670|NCT03282799|141392322|OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||.660
70945671|NCT03282799|141392323|OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||.290
70945672|NCT00092521|141392330|SUPERIORITY_OR_OTHER||Percent relative risk reduction|100.0||||||95.0|95.1|100.0|||||Confidence Interval (CI) based on binomial tail probabilities and not from a dispersion parameter|||100|95.1|
70945673|NCT00092521|141392331|SUPERIORITY_OR_OTHER||Percent relative risk reduction|100.0||||||95.0|94.9|100.0|||||CI based on binomial tail probabilities and not from a dispersion parameter|||100|94.9|
70945674|NCT02161406|141392426|SUPERIORITY|||||||0.28|||||||Mixed Models Analysis|||||||0.28
70945675|NCT02161406|141392427|SUPERIORITY|||||||0.73|||||||Mixed Models Analysis|||||||0.73
70945676|NCT02161406|141392428|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
70945677|NCT02161406|141392429|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||||||0.11
70945678|NCT02161406|141392430|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|||||||0.19
70945679|NCT02161406|141392431|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|||||||0.005
70945680|NCT02161406|141392432|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|||||||0.19
70945681|NCT02161406|141392433|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|||||||0.34
70945682|NCT02161406|141392434|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||0.25
70945683|NCT02161406|141392435|SUPERIORITY|||||||0.12|||||||Mixed Models Analysis|||||||0.12
70945684|NCT02161406|141392436|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||||||0.82
70945685|NCT02161406|141392437|SUPERIORITY|||||||0.37|||||||Mixed Models Analysis|||||||0.37
70945686|NCT02161406|141392438|SUPERIORITY|||||||0.55|||||||Mixed Models Analysis|||||||0.55
70945687|NCT02161406|141392439|SUPERIORITY|||||||0.15|||||||Mixed Models Analysis|||||||0.15
70945688|NCT02161406|141392440|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||||||0.21
70945689|NCT02161406|141392441|SUPERIORITY|||||||0.81|||||||Mixed Models Analysis|||||||0.81
70945690|NCT02161406|141392442|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|||||||0.86
70945691|NCT02161406|141392443|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|||||||0.91
70945692|NCT02161406|141392444|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||||||0.13
70945693|NCT02161406|141392445|SUPERIORITY|||||||0.92|||||||Mixed Models Analysis|||||||0.92
71125108|NCT00752726|141756344|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.974||0.085|TWO_SIDED|95.0|-0.24|3.63||P-value was not adjusted for multiple comparisons|ANCOVA|Mean change was adjusted for the treatment, baseline waist circumference and center effects, using an ANCOVA model.|Adjusted mean difference between Placebo group and Orlistat group was determined.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||3.63|-0.24|0.085
71125109|NCT00752726|141756346|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.023|STANDARD_ERROR_OF_MEAN|0.0232||0.3235|TWO_SIDED|95.0|-0.069|0.023||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean change was adjusted for the treatment, baseline liver fat and center effects, using an ANCOVA model.|Adjusted mean difference between placebo group and Orlistat group was evaluated.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||0.023|-0.069|0.3235
71125110|NCT00752726|141756347|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|783.8|STANDARD_ERROR_OF_MEAN|726.54||0.28|TWO_SIDED|95.0|-657.3|2224.9||P-value was not adjusted for multiple comparisons|ANCOVA|Mean change was adjusted for the treatment, baseline total calories expended and center effects using an ANCOVA model.|Adjusted mean difference between placebo group and Orlistat group was evaluated.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||2224.9|-657.3|0.28
71125111|NCT00752726|141756348|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.66|STANDARD_ERROR_OF_MEAN|1.542||0.2847|TWO_SIDED|95.0|-1.4|4.72||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean difference was adjusted for the treatment, baseline value and center effects using an ANCOVA model.|Adjusted mean difference was calculated as placebo minus orlistat.|The null hypothesis considered no difference in the change from baseline to week 24 between the treatment groups.||4.72|-1.40|0.2847
71125112|NCT04232215|141756362|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.64|TWO_SIDED|95.0|-10.2|6.1|||Regression, Linear|A generalized linear model adjusting by intervention group and the order of randomization was conducted.||Difference in ease of use between our standard fetal Doppler and HeraBEAT™ device, as measured by the System Usability Survey (SUS) will be the primary outcome. We aim to recruit 50 participants (50 per arm, with cross-over) for a 99.7% power to detect a 10-point difference in SUS, as this accounts for a withdraw / post-randomization exclusion as high as 10% (assuming a proportion of expectant mothers to withdraw participation after being enrolled or found to not meet criteria after the fact).||6.1|-10.2|0.64
71125113|NCT04232215|141756363|SUPERIORITY||Risk Ratio (RR)|1.2||||0.63|TWO_SIDED|95.0|0.57|2.53|||Chi-squared|||||2.53|0.57|0.63
71125114|NCT01078168|141756415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3769||||0.0347|TWO_SIDED|95.0|0.03025|0.7235||threshold: p\<0.05|t-test, 2 sided|||||0.7235|0.03025|0.0347
71125115|NCT02905006|141756446|SUPERIORITY||||||<|0.0001||||||P-value evaluating dose response excludes the BKZ Dose 3 group; is based on a logistic regression model with fixed effects for region, prior biologic exposure, continuous treatment variable with values of -2, -1, 0, 1, 2 for the remaining groups.|Regression, Logistic|||||||<0.0001
71125116|NCT02905006|141756446|SUPERIORITY||||||<|0.0001||||||P-value evaluating dose response excludes the BKZ Dose 3 group; is based on a logistic regression model with fixed effects for region, prior biologic exposure, continuous treatment variable with values of -2, -1, 0, 1, 2 for the remaining groups.|Regression, Logistic|||||||<0.0001
71125117|NCT02905006|141756446|SUPERIORITY||||||<|0.0001||||||P-value evaluating dose response excludes the BKZ Dose 3 group; is based on a logistic regression model with fixed effects for region, prior biologic exposure, continuous treatment variable with values of -2, -1, 0, 1, 2 for the remaining groups.|Regression, Logistic|||||||<0.0001
71125118|NCT02905006|141756446|SUPERIORITY||||||<|0.0001||||||P-value evaluating dose response excludes the BKZ Dose 3 group; is based on a logistic regression model with fixed effects for region, prior biologic exposure, continuous treatment variable with values of -2, -1, 0, 1, 2 for the remaining groups.|Regression, Logistic|||||||<0.0001
71125119|NCT02905006|141756447|SUPERIORITY||Odds Ratio (OR)|21.43|||=|0.0001|TWO_SIDED|95.0|4.51|101.88|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||101.88|4.51|=0.0001
71125120|NCT02905006|141756447|SUPERIORITY||Odds Ratio (OR)|63.21|||<|0.0001|TWO_SIDED|95.0|12.9|309.83|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||309.83|12.90|<0.0001
71125121|NCT02905006|141756447|SUPERIORITY||Odds Ratio (OR)|62.35|||<|0.0001|TWO_SIDED|95.0|12.61|308.29|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||308.29|12.61|<0.0001
71125122|NCT02905006|141756447|SUPERIORITY||Odds Ratio (OR)|130.35|||<|0.0001|TWO_SIDED|95.0|24.5|693.51|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||693.51|24.50|<0.0001
70945694|NCT02161406|141392446|SUPERIORITY|||||||0.24|||||||Mixed Models Analysis|||||||0.24
70945695|NCT02161406|141392447|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|||||||0.07
70945696|NCT02161406|141392448|SUPERIORITY|||||||0.03|||||||van Elteren test|The van Elteren test adjusted for duration of dcSSc. Multiple imputation was used to address missing follow-up data in 5 components of CRISS.||||||0.03
70857115|NCT02446743|141200512|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-27.0|||||TWO_SIDED|95.0|-41.8|-12.9|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-12.9|-41.8|
70857116|NCT02446743|141200512|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|3.0|||||TWO_SIDED|95.0|-6.0|16.2|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||16.2|-6.0|
70857117|NCT02446743|141200512|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|7.0|||||TWO_SIDED|95.0|1.4|15.2|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||15.2|1.4|
70857118|NCT02446743|141200512|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-31.0|||||TWO_SIDED|95.0|-45.1|-14.6|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-14.6|-45.1|
70857119|NCT02446743|141200512|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|4.0|||||TWO_SIDED|95.0|1.9|13.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||13.5|1.9|
70945697|NCT02161406|141392449|SUPERIORITY|||||||0.1769|||||||Mixed Models Analysis|||||||0.1769
70945698|NCT02161406|141392450|SUPERIORITY|||||||0.9075|||||||Mixed Models Analysis|||||||0.9075
70945699|NCT02161406|141392451|SUPERIORITY|||||||0.5831|||||||Mixed Models Analysis|||||||0.5831
71125123|NCT02905006|141756447|SUPERIORITY||Odds Ratio (OR)|69.4|||<|0.0001|TWO_SIDED|95.0|14.07|342.4|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||342.40|14.07|<0.0001
71125124|NCT02905006|141756448|SUPERIORITY||Odds Ratio (OR)|18.23|||=|0.0003|TWO_SIDED|95.0|3.79|87.76|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||87.76|3.79|=0.0003
71125125|NCT02905006|141756448|SUPERIORITY||Odds Ratio (OR)|39.6|||<|0.0001|TWO_SIDED|95.0|8.19|191.59|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||191.59|8.19|<0.0001
71125126|NCT02905006|141756448|SUPERIORITY||Odds Ratio (OR)|77.27|||<|0.0001|TWO_SIDED|95.0|15.19|392.93|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||392.93|15.19|<0.0001
71125127|NCT02905006|141756448|SUPERIORITY||Odds Ratio (OR)|141.99|||<|0.0001|TWO_SIDED|95.0|26.26|767.72|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||767.72|26.26|<0.0001
71125128|NCT02905006|141756448|SUPERIORITY||Odds Ratio (OR)|58.52|||<|0.0001|TWO_SIDED|95.0|11.89|288.0|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||288.00|11.89|<0.0001
71125129|NCT02905006|141756449|SUPERIORITY||||||<|0.0001||||||The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.|Fisher Exact|||||||<0.0001
71125130|NCT02905006|141756449|SUPERIORITY||||||<|0.0001||||||The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.|Fisher Exact|||||||<0.0001
71125131|NCT02905006|141756449|SUPERIORITY||||||<|0.0001||||||The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.|Fisher Exact|||||||<0.0001
71125132|NCT02905006|141756449|SUPERIORITY||||||<|0.0001||||||The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.|Fisher Exact|||||||<0.0001
71125133|NCT02905006|141756449|SUPERIORITY||||||<|0.0001||||||The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.|Fisher Exact|||||||<0.0001
71125134|NCT02905006|141756450|SUPERIORITY||Odds Ratio (OR)|32.65|||<|0.0001|TWO_SIDED|95.0|6.82|156.38|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||156.38|6.82|<0.0001
71125135|NCT02905006|141756450|SUPERIORITY||Odds Ratio (OR)|94.51|||<|0.0001|TWO_SIDED|95.0|18.54|481.86|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||481.86|18.54|<0.0001
71125136|NCT02905006|141756450|SUPERIORITY||Odds Ratio (OR)|117.66|||<|0.0001|TWO_SIDED|95.0|22.08|626.89|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||626.89|22.08|<0.0001
71125137|NCT02905006|141756450|SUPERIORITY||Odds Ratio (OR)|280.76|||<|0.0001|TWO_SIDED|95.0|44.06|1789.24|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||1789.24|44.06|<0.0001
71125138|NCT02905006|141756450|SUPERIORITY||Odds Ratio (OR)|107.83|||<|0.0001|TWO_SIDED|95.0|20.82|558.57|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||558.57|20.82|<0.0001
71087644|NCT01115452|141681480|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.1||||0.634|TWO_SIDED|95.0|-10.8|6.6||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.60|-10.80|0.6340
71087645|NCT01115452|141681480|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.48||||0.9127|TWO_SIDED|95.0|-8.2|9.16|||ANCOVA|No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||9.16|-8.20|0.9127
71125139|NCT02905006|141756451|SUPERIORITY||||||=|0.0001|||||||Fisher Exact|||The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.||||=0.0001
70945700|NCT02161406|141392452|SUPERIORITY|||||||0.0193|||||||Mixed Models Analysis|||||||0.0193
70945701|NCT02161406|141392453|SUPERIORITY|||||||0.0097|||||||Mixed Models Analysis|||||||0.0097
71125140|NCT02905006|141756451|SUPERIORITY||||||=|0.0002|||||||Fisher Exact|||The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.||||=0.0002
71125141|NCT02905006|141756451|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.||||<0.0001
71125142|NCT02905006|141756451|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.||||<0.0001
71125143|NCT02905006|141756451|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.||||<0.0001
71125144|NCT04201093|141756489|SUPERIORITY||LS Mean of Difference|-11.5|STANDARD_ERROR_OF_MEAN|1.16|<|0.0001|TWO_SIDED|95.0|-13.8|-9.2||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||||-9.2|-13.8|<0.0001
71125145|NCT04201093|141756489|SUPERIORITY||LS Mean of Difference|-12.1|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-14.4|-9.8||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||||-9.8|-14.4|<0.0001
71125146|NCT04201093|141756490|SUPERIORITY||LS Mean of Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-3.3|-1.7||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||||-1.7|-3.3|<0.0001
71125147|NCT04201093|141756490|SUPERIORITY||LS Mean of Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-3.4|-1.7||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||||-1.7|-3.4|<0.0001
71125148|NCT04201093|141756491|SUPERIORITY||Odds Ratio (OR)|6.148|||<|0.0001|TWO_SIDED|95.0|3.339|11.321|||Mixed Models Analysis|||||11.321|3.339|<0.0001
71125149|NCT04201093|141756491|SUPERIORITY||Odds Ratio (OR)|5.968|||<|0.0001|TWO_SIDED|95.0|3.22|11.062|||Mixed Models Analysis|||||11.062|3.220|<0.0001
71125150|NCT04201093|141756492|SUPERIORITY||LS Mean of Difference|-11.5|STANDARD_ERROR_OF_MEAN|1.16|<|0.0001|TWO_SIDED|95.0|-13.8|-9.2||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-9.2|-13.8|<0.0001
71125151|NCT04201093|141756492|SUPERIORITY||LS Mean of Difference|-12.1|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-14.4|-9.8||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-9.8|-14.4|<0.0001
71125152|NCT04201093|141756493|SUPERIORITY||LS Mean of Difference|-11.7|STANDARD_ERROR_OF_MEAN|1.35|<|0.0001|TWO_SIDED|95.0|-14.4|-9.1||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-9.1|-14.4|<0.0001
71125153|NCT04201093|141756493|SUPERIORITY||LS Mean of Difference|-12.0|STANDARD_ERROR_OF_MEAN|1.37|<|0.0001|TWO_SIDED|95.0|-14.7|-9.3||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-9.3|-14.7|<0.0001
71125154|NCT04201093|141756494|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.38||0.4822|TWO_SIDED|95.0|-1.0|0.5||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Part I: Week 26||0.5|-1.0|0.4822
71125155|NCT04201093|141756494|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.38||0.7742|TWO_SIDED|95.0|-0.9|0.6||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Part I: Week 26||0.6|-0.9|0.7742
71087646|NCT01115452|141681481|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.15||||0.6192|TWO_SIDED|95.0|-10.67|6.38||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.38|-10.67|0.6192
71087647|NCT01115452|141681481|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.6||||0.8912|TWO_SIDED|95.0|-8.1|9.3||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||9.30|-8.10|0.8912
71125156|NCT04201093|141756494|SUPERIORITY||LS Mean of Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-3.3|-1.7||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Part II: Week 26||-1.7|-3.3|<0.0001
70857120|NCT02446743|141200512|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|8.0|||||TWO_SIDED|95.0|4.4|15.0|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||15.0|4.4|
71125157|NCT04201093|141756494|SUPERIORITY||LS Mean of Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-3.4|-1.7||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Part II: Week 26||-1.7|-3.4|<0.0001
71125158|NCT04201093|141756494|SUPERIORITY||LS Mean of Difference|-9.0|STANDARD_ERROR_OF_MEAN|0.89|<|0.0001|TWO_SIDED|95.0|-10.8|-7.3||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Part III: Week 26||-7.3|-10.8|<0.0001
71125159|NCT04201093|141756494|SUPERIORITY||LS Mean of Difference|-9.4|STANDARD_ERROR_OF_MEAN|0.9|<|0.0001|TWO_SIDED|95.0|-11.2|-7.6||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Part III: Week 26||-7.6|-11.2|<0.0001
71125160|NCT04201093|141756495|SUPERIORITY||LS Mean of Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.6|-0.3||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.3|-0.6|<0.0001
71125161|NCT04201093|141756495|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.5|-0.2||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.2|-0.5|<0.0001
71125162|NCT04201093|141756496|SUPERIORITY||LS Mean of Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.9|-1.4|<0.0001
70857121|NCT02446743|141200512|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-5.0|||||TWO_SIDED|95.0|-16.0|6.5|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||6.5|-16.0|
71125163|NCT04201093|141756496|SUPERIORITY||LS Mean of Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.7|-1.2|<0.0001
71125164|NCT04201093|141756497|SUPERIORITY||LS Mean of Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.9|-1.4|<0.0001
71125165|NCT04201093|141756497|SUPERIORITY||LS Mean of Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.5|-0.9||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.9|-1.5|<0.0001
71125166|NCT04201093|141756498|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.32||0.6047|TWO_SIDED|95.0|-0.8|0.5||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||0.5|-0.8|0.6047
70857122|NCT02446743|141200512|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-0.9|6.2|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||6.2|-0.9|
70857123|NCT02446743|141200512|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-0.33|5.0|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.0|-0.33|
70945702|NCT02161406|141392454|SUPERIORITY|||||||0.0751|||||||Mixed Models Analysis|||||||0.0751
70945703|NCT02161406|141392455|SUPERIORITY|||||||0.4927|||||||Mixed Models Analysis|||||||0.4927
70857124|NCT02446743|141200512|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-6.0|||||TWO_SIDED|95.0|-20.5|10.6|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||10.6|-20.5|
70857125|NCT02446743|141200512|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.6|8.8|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.8|-3.6|
70945704|NCT02161406|141392456|SUPERIORITY|||||||0.1604|||||||Mixed Models Analysis|||||||0.1604
70945705|NCT02161406|141392457|SUPERIORITY|||||||0.7281|||||||Mixed Models Analysis|||||||0.7281
70945706|NCT02161406|141392458|SUPERIORITY|||||||0.1679|||||||Mixed Models Analysis|||||||0.1679
70945707|NCT02161406|141392459|SUPERIORITY|||||||0.2906|||||||Mixed Models Analysis|||||||0.2906
70945708|NCT02034162|141392460|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||< 0.001
71087648|NCT01115452|141681481|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.75||||0.5321|TWO_SIDED|95.0|-5.93|11.43||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution|Null hypothesis is no difference between treatments.||11.43|-5.93|0.5321
71087649|NCT01115452|141681482|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.37||||0.4055|TWO_SIDED|95.0|-11.37|4.63||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||4.63|-11.37|0.4055
71087650|NCT01115452|141681482|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.74||||0.8573|TWO_SIDED|95.0|-7.42|8.91||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||8.91|-7.42|0.8573
71087651|NCT01115452|141681482|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.12||||0.3193|TWO_SIDED|95.0|-4.03|12.27||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||12.27|-4.03|0.3193
71087652|NCT01115452|141681483|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.23||||0.4264||95.0|-4.77|11.23||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||11.23|-4.77|0.4264
71087653|NCT01115452|141681483|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.04||||0.8008|TWO_SIDED|95.0|-7.42|9.21||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution|Null hypothesis is no difference between treatments.||9.21|-7.42|0.8008
71087654|NCT01115452|141681483|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.18||||0.5969|TWO_SIDED|95.0|-10.33|5.97||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||5.97|-10.33|0.5969
71087655|NCT01115452|141681484|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.14||||0.2059|TWO_SIDED|95.0|-13.14|2.86||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||2.86|-13.14|0.2059
71087656|NCT01115452|141681484|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.39||||0.9248|TWO_SIDED|95.0|-8.56|7.77||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||7.77|-8.56|0.9248
71087657|NCT01115452|141681484|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.75||||0.2508|TWO_SIDED|95.0|-3.4|12.9||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||12.90|-3.40|0.2508
70945709|NCT02034162|141392461|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||< 0.001
70945710|NCT02034162|141392463|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
70945711|NCT02034162|141392464|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
70945712|NCT00858247|141392491|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANCOVA|||||||0.95
70945713|NCT00858247|141392492|SUPERIORITY_OR_OTHER|||||||0.8|||||||ANCOVA|||||||0.80
70945714|NCT00858247|141392493|SUPERIORITY_OR_OTHER|||||||0.65|||||||ANCOVA|||||||0.65
70945715|NCT00858247|141392494|SUPERIORITY_OR_OTHER|||||||0.68|||||||ANCOVA|||||||0.68
70945716|NCT00858247|141392495|SUPERIORITY_OR_OTHER|||||||0.4|||||||ANCOVA|||||||0.40
70945717|NCT00858247|141392496|SUPERIORITY_OR_OTHER|||||||0.47|||||||ANCOVA|||||||0.47
70945718|NCT00337285|141392497|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||< 0.0001
70945719|NCT00337285|141392499|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||< 0.0001
70945720|NCT00553605|141392500|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower bound of the 2-sided 95% CI of the treatment difference (parecoxib - ketoprofen) was greater than -10 mm.|Least-squares (LS) mean difference|-1.12|STANDARD_ERROR_OF_MEAN|2.75|||TWO_SIDED|95.0|-6.53|4.3||||||LS mean difference and 95 percent (%) confidence interval (CI) were based on analysis of covariance (ANCOVA) model with terms for treatment group and country, and baseline as covariates.||4.30|-6.53|
70945721|NCT00553605|141392501|SUPERIORITY_OR_OTHER||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|2.52||0.972|TWO_SIDED|95.0|-5.04|4.86|||ANCOVA|||p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||4.86|-5.04|0.972
71087658|NCT01115452|141681485|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.12||||0.7822|TWO_SIDED|95.0|-6.86|9.1||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||9.10|-6.86|0.7822
71087659|NCT01115452|141681485|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.44||||0.7208|TWO_SIDED|95.0|-6.52|9.41||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||9.41|-6.52|0.7208
70945722|NCT00553605|141392503|SUPERIORITY_OR_OTHER||LS mean difference|0.75|STANDARD_ERROR_OF_MEAN|2.56||0.768|TWO_SIDED|95.0|-4.28|5.79|||ANCOVA|||Minute 15: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||5.79|-4.28|0.768
70945723|NCT00553605|141392503|SUPERIORITY_OR_OTHER||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|2.91||0.866|TWO_SIDED|95.0|-6.22|5.24|||ANCOVA|||Minute 30: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||5.24|-6.22|0.866
70945724|NCT00553605|141392503|SUPERIORITY_OR_OTHER||LS mean difference|0.94|STANDARD_ERROR_OF_MEAN|2.7||0.729|TWO_SIDED|95.0|-4.38|6.26|||ANCOVA|||Minute 45: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||6.26|-4.38|0.729
70945725|NCT00553605|141392503|SUPERIORITY_OR_OTHER||LS mean difference|2.62|STANDARD_ERROR_OF_MEAN|2.47||0.29|TWO_SIDED|95.0|-2.24|7.48|||ANCOVA|||Minute 60: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||7.48|-2.24|0.290
70945726|NCT00553605|141392503|SUPERIORITY_OR_OTHER||LS mean difference|2.16|STANDARD_ERROR_OF_MEAN|2.14||0.314|TWO_SIDED|95.0|-2.05|6.37|||ANCOVA|||Minute 90: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||6.37|-2.05|0.314
70945727|NCT00553605|141392503|SUPERIORITY_OR_OTHER||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|1.72||0.926|TWO_SIDED|95.0|-3.23|3.55|||ANCOVA|||Minute 120: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||3.55|-3.23|0.926
70945728|NCT00553605|141392504|SUPERIORITY_OR_OTHER||LS mean difference|10.13|STANDARD_ERROR_OF_MEAN|13.43||0.451|TWO_SIDED|95.0|-16.3|36.54|||ANCOVA|||p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country as covariates.||36.54|-16.3|0.451
70945729|NCT00553605|141392505|SUPERIORITY_OR_OTHER|||||||0.3982|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Minute 30: p-value was calculated using Cochran-Mantel-Haenszel (CMH) model and using modified ridit scores, testing for non-zero correlation and controlling for country.||||0.3982
70945730|NCT00553605|141392505|SUPERIORITY_OR_OTHER|||||||0.5552|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Minute 120: p-value was calculated using Cochran-Mantel-Haenszel (CMH) model and using modified ridit scores, testing for non-zero correlation and controlling for country.||||0.5552
70945731|NCT00553605|141392506|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.007||||0.9785|TWO_SIDED|95.0|0.6|1.69|||Regression, Logistic|||p-value was based on logistic regression model with terms for treatment group and baseline as covariates.||1.69|0.60|0.9785
70945732|NCT00553605|141392507|SUPERIORITY_OR_OTHER|||||||0.2482|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Minute 30: p-value was calculated using Cochran-Mantel-Haenszel (CMH) model and using modified ridit scores, testing for non-zero correlation and controlling for country.||||0.2482
70945733|NCT00553605|141392507|SUPERIORITY_OR_OTHER|||||||0.7659|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Minute 120: p-value was calculated using CMH model and using modified ridit scores, testing for non-zero correlation and controlling for country.||||0.7659
71125167|NCT04201093|141756498|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.33||0.257|TWO_SIDED|95.0|-1.0|0.3||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||0.3|-1.0|0.2570
71125168|NCT04201093|141756499|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.63||0.8516|TWO_SIDED|95.0|-1.4|1.1||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||1.1|-1.4|0.8516
71125169|NCT04201093|141756499|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.64||0.6421|TWO_SIDED|95.0|-1.6|1.0||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||1.0|-1.6|0.6421
70945734|NCT00553605|141392508|SUPERIORITY_OR_OTHER|||||||0.9783|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Minute 30: p-value was calculated using CMH model and using modified ridit scores, testing for non-zero correlation and controlling for country.||||0.9783
71125170|NCT04051827|141756549|OTHER|Geometric Mean Ratio|Geometric Mean Ratio (GMR)|1.03|||||TWO_SIDED|90.0|0.739|1.42|||||The geometric mean ratio (GMR) of midazolam Cmax on Day 24 (with mobocertinib) versus on Day 1 (without mobocertinib) were calculated.|The ratios of geometric mean midazolam Cmax (in the presence vs absence of mobocertinib) and the associated 2-sided 90 percent (%) confidence intervals (CIs) were calculated on the basis of the within-patient variance using a mixed-effects analysis of variance (ANOVA) model fitting terms for treatment (midazolam in the absence and presence of mobocertinib).||1.42|0.739|
70857126|NCT02446743|141200512|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.6|4.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.4|-3.6|
70857127|NCT02446743|141200512|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-4.0|||||TWO_SIDED|95.0|-19.4|13.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||13.0|-19.4|
70857128|NCT02446743|141200512|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.5|11.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||11.0|-2.5|
70857129|NCT02446743|141200512|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|3.0|||||TWO_SIDED|95.0|-1.2|9.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||9.4|-1.2|
70857130|NCT02446743|141200512|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-20.0|||||TWO_SIDED|95.0|-30.0|-11.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-11.1|-30.0|
70857131|NCT02446743|141200512|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|4.0|||||TWO_SIDED|95.0|-7.6|15.7|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||15.7|-7.6|
70857132|NCT02446743|141200512|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|32.0|||||TWO_SIDED|95.0|23.2|40.2|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||40.2|23.2|
70945735|NCT00553605|141392508|SUPERIORITY_OR_OTHER|||||||0.6847|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Minute 120: p-value was calculated using CMH model and using modified ridit scores, testing for non-zero correlation and controlling for country.||||0.6847
70945736|NCT00553605|141392509|SUPERIORITY_OR_OTHER|||||||0.9645|TWO_SIDED||||||Log Rank|||||||0.9645
70945737|NCT01101997|141392523|SUPERIORITY||sucess proportion|0.853|||<|0.001|TWO_SIDED|95.0|0.773|0.91|||Chi-squared|||H0: p= 0.6 and Ha: p ≠ 0.6||.910|.773|<0.001
70945738|NCT01101997|141392524|OTHER||Mean Difference (Net)|-1.9|STANDARD_DEVIATION|2.49|||TWO_SIDED|||||||||||||
70945739|NCT02669407|141392532|OTHER|Single group|||||<|0.001|||||||Tukey's method|||||||<0.001
70945740|NCT02669407|141392533|OTHER|Single group||||||0.001|||||||Tukey's method|||Baseline, 30 minutes||||0.001
70945741|NCT02669407|141392534|OTHER|Single group||||||0.007|||||||Tukey's method|||baseline, 30 minutes||||0.007
70945742|NCT02669407|141392538|OTHER|Single group||||||0.237|||||||t-test, 2 sided|||Change in left ventricular end diastolic dimension||||0.237
70945743|NCT02669407|141392538|OTHER|Single group||||||0.586|||||||t-test, 2 sided|||Change in left ventricular end systolic dimension||||0.586
70945744|NCT02669407|141392539|OTHER|Single group||||||0.175|||||||t-test, 2 sided|||||||0.175
70945745|NCT02669407|141392541|OTHER|Single group||||||0.061|||||||t-test, 2 sided|||||||0.061
70945746|NCT02669407|141392542|OTHER|Single group||||||0.787|||||||t-test, 2 sided|||||||0.787
70945747|NCT02669407|141392544|OTHER|Single group||||||0.606|||||||t-test, 2 sided|||Baseline, 90 minutes||||0.606
70945748|NCT02669407|141392544|OTHER|Single group||||||0.045|||||||t-test, 2 sided|||Baseline, 24 hours||||0.045
70945749|NCT03634839|141392545|SUPERIORITY||Mean Difference (Final Values)|-5.184||||0.053|TWO_SIDED||||||t-test, 2 sided|||||||0.053
70857133|NCT02446743|141200512|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-13.0|||||TWO_SIDED|95.0|-25.9|-3.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-3.0|-25.9|
70857134|NCT02446743|141200512|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-17.1|15.9|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||15.9|-17.1|
70945750|NCT03634839|141392546|SUPERIORITY||Mean Difference (Final Values)|-1.881||||0.187|TWO_SIDED||||||t-test, 2 sided|||Outcome analyses will be intent-to-treat and using mixed-effects models with flavor as a within-subject factor. A significant main effect of flavor with greater liking of sweet plus cooling flavor than sweet minus cooling flavor will be considered supportive of our hypotheses.||||0.187
70945751|NCT03634839|141392547|SUPERIORITY||Mean Difference (Final Values)|-0.286||||0.135|TWO_SIDED||||||t-test, 2 sided|||||||0.135
70945752|NCT03634839|141392548|SUPERIORITY||Mean Difference (Final Values)|1.942||||0.21|TWO_SIDED||||||t-test, 2 sided|||||||0.210
70857135|NCT02446743|141200512|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|33.0|||||TWO_SIDED|95.0|20.5|45.3|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||45.3|20.5|
70857136|NCT02446743|141200512|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-25.0|||||TWO_SIDED|95.0|-40.1|-11.2|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-11.2|-40.1|
70857137|NCT02446743|141200512|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|12.0|||||TWO_SIDED|95.0|-3.9|28.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||28.1|-3.9|
70857138|NCT02446743|141200512|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|33.0|||||TWO_SIDED|95.0|22.0|44.1|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||44.1|22.0|
70857139|NCT02446743|141200512|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-5.0|||||TWO_SIDED|95.0|-16.0|6.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||6.0|-16.0|
71125171|NCT04051827|141756550|OTHER|Geometric Mean Ratio|Geometric Mean Ratio (GMR)|0.676|||||TWO_SIDED|90.0|0.532|0.859|||||The GMR of midazolam AUC∞ on Day 24 (with mobocertinib) versus on Day 1 (without mobocertinib) were calculated.|The ratios of geometric mean midazolam AUC∞ (in the presence vs absence of mobocertinib) and the associated 2-sided 90% CIs were calculated on the basis of the within-patient variance using a mixed-effects ANOVA model fitting terms for treatment (midazolam in the absence and presence of mobocertinib).||0.859|0.532|
71125172|NCT04051827|141756551|OTHER|Geometric Mean Ratio|Geometric Mean Ratio (GMR)|1.3|||||TWO_SIDED|90.0|0.886|1.92|||||The GMR of midazolam Cmax on Day 25 (with mobocertinib) versus on Day 2 (without mobocertinib) were calculated.|The ratios of geometric mean midazolam Cmax (in the presence vs absence of mobocertinib) and the associated 2-sided 90% CIs were calculated on the basis of the within-patient variance using a mixed-effects ANOVA model fitting terms for treatment (midazolam in the absence and presence of mobocertinib).||1.92|0.886|
71125173|NCT04051827|141756552|OTHER|Geometric Mean Ratio|Geometric Mean Ratio (GMR)|0.837|||||TWO_SIDED|90.0|0.673|1.04|||||The GMR of midazolam AUC∞ on Day 25 (with mobocertinib) versus on Day 2 (without mobocertinib) were calculated.|The ratios of geometric mean midazolam AUC∞ (in the presence vs absence of mobocertinib) and the associated 2-sided 90% CIs were calculated on the basis of the within-patient variance using a mixed-effects ANOVA model fitting terms for treatment (midazolam in the absence and presence of mobocertinib).||1.04|0.673|
71125174|NCT03743064|141756567|SUPERIORITY|The Multiple Imputation process (N=100) was performed leading to least squares mean (LSM) and standard error (SE) estimates using the ANOVA model (including treatment group and the 3 stratification factors at randomization as categorical covariates). The estimates were pooled using Rubin rule, with corresponding p-value for difference between treatment groups. The 95% confidence interval (CI) was calculated for each treatment group and for the pooled difference between the groups.|Mean Difference (Final Values)|1.284|STANDARD_ERROR_OF_MEAN|0.289|<|0.0001|TWO_SIDED|95.0|0.718|1.851|||ANOVA|||"To declare anamorelin superior to placebo, both co-primary endpoints had to be significant.~The null hypothesis for mean change in body weight from baseline over 12 weeks (H0w) and the corresponding alternative hypothesis (H1w) were:~H0w: MWa = MWp H1w: MWa ≠ MWp~Where MWa is the mean change in body weight from baseline over 12 weeks for the anamorelin arm and MWp is the mean change in body weight from baseline over 12 weeks for the placebo arm."||1.851|0.718|<0.0001
71125175|NCT03743064|141756568|SUPERIORITY|The Multiple Imputation process (N=100) was performed leading to least squares mean (LSM) and standard error (SE) estimates using the ANOVA model (including treatment group and the 3 stratification factors at randomization as categorical covariates). The estimates were pooled using Rubin rule, with corresponding p-value for difference between treatment groups. The 95% confidence interval (CI) was calculated for each treatment group and for the pooled difference between the groups.|Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.399||0.7241|TWO_SIDED|95.0|-0.641|0.923|||ANOVA|||"To declare anamorelin superior to the placebo, both co-primary endpoints had to be significant. The null hypothesis for mean change from baseline over 12 weeks in patient 5-IASS (H0A) and the corresponding alternative (H1A) were:~H0A: MAa = MAp; H1A: MAa ≠ MAp~Where MAa is the mean change from baseline over 12 weeks in 5-IASS for the anamorelin arm and MAp is the mean change from baseline over 12 weeks in 5-IASS for the placebo arm."||0.923|-0.641|0.7241
71125176|NCT03743064|141756569|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|2.081|STANDARD_ERROR_OF_MEAN|0.579||0.0003|TWO_SIDED|95.0|0.946|3.216|||ANOVA|||||3.216|0.946|0.0003
71125177|NCT03743064|141756570|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|2.404|STANDARD_ERROR_OF_MEAN|0.476|<|0.0001|TWO_SIDED|95.0|1.471|3.337|||ANOVA|||||3.337|1.471|<0.0001
71125178|NCT03743064|141756571|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|0.629|STANDARD_ERROR_OF_MEAN|0.431||0.1443|TWO_SIDED|95.0|-0.215|1.472|||ANOVA|||||1.472|-0.215|0.1443
71125179|NCT03743064|141756572|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.452||0.7376|TWO_SIDED|95.0|-0.734|1.036|||ANOVA|||||1.036|-0.734|0.7376
71125180|NCT01852383|141756588|SUPERIORITY_OR_OTHER||||||<|0.001||||||Change from Week 0 to Week 12, not adjusted for multiple comparisons. Alpha=0.05 threshold for statistical significance.|ANCOVA|||||||<0.001
71125181|NCT01852383|141756589|SUPERIORITY_OR_OTHER||||||<|0.1||||||Change from Week 0 to Week 12, not adjusted for multiple comparisons. Alpha=0.05 threshold for statistical significance.|Corrlation|||||||<0.1
71125182|NCT01852383|141756590|SUPERIORITY_OR_OTHER||||||<|0.001||||||Change from Week 0 to Week 12, not adjusted for multiple comparisons. Alpha=0.05 threshold for statistical significance.|ANCOVA|||||||<0.001
71125183|NCT01852383|141756591|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0||||Pearson correlation coefficient. Not adjusted for multiple comparisons. Alpha=0.05 for statistical significance threshold.|Pearson correlation|||Correlation of maximum duloxetine dose with change in Hamilton Depression Rating Scale scores from 0 Weeks to 12 Weeks.||||<.001
71125184|NCT01300455|141756609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.66|||||TWO_SIDED|90.0|0.22|5.09|||Difference of the Least Squares Means|||Difference (Suvorexant - Placebo) of Least Squares Means||5.09|0.22|
71125185|NCT01300455|141756612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|90.0|-0.49|0.42|||Difference in the Least Squares Means|||Day 1, Difference (Suvorexant - Placebo) of Least Squares Means||0.42|-0.49|
71125186|NCT01300455|141756612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|90.0|-0.45|0.33|||Difference of the Least Squares Means|||Day 4, Difference (Suvorexant - Placebo) of Least Squares Means||0.33|-0.45|
71125187|NCT01300455|141756613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|||||TWO_SIDED|90.0|-1.31|2.79|||Difference in the Least Squares Means|||Day 1, SaO2 \<90%, Difference (Suvorexant - Placebo) of Least Squares Means||2.79|-1.31|
71125188|NCT01300455|141756613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||||TWO_SIDED|90.0|-0.1|0.59|||Difference in the Least Squares Means|||Day 1, SaO2 \<85%, Difference (Suvorexant - Placebo) of Least Squares Means||0.59|-0.10|
71125189|NCT01300455|141756613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|||||TWO_SIDED|90.0|-0.59|1.01|||Difference in the Least Squares Means|||Day 4, SaO2 \<90%, Difference (Suvorexant - Placebo) of Least Squares Means||1.01|-0.59|
71125190|NCT01300455|141756613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|||||TWO_SIDED|90.0|-0.09|0.65|||Difference in the Least Squares Means|||Day 4, SaO2 \<85%, Difference (Suvorexant - Placebo) of Least Squares Means||0.65|-0.09|
71125191|NCT01300455|141756614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|90.0|-0.61|0.49|||Difference of Least Squares Means|||Day 1, REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.49|-0.61|
71125192|NCT01300455|141756614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|||||TWO_SIDED|90.0|-0.41|0.5|||Difference of the Least Sqares Means|||Day 1, Non-REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.50|-0.41|
71125193|NCT01300455|141756614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|||||TWO_SIDED|90.0|-1.13|0.1|||Difference of the Least Squares Means|||Day 1, Wake, Difference (Suvorexant - Placebo) of Least Squares Means||0.10|-1.13|
71125194|NCT01300455|141756614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|||||TWO_SIDED|90.0|-0.24|0.5|||Difference of the Least Squares Means|||Day 4, REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.50|-0.24|
71125195|NCT01300455|141756614|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.02|||||TWO_SIDED|90.0|-0.4|0.43|||Difference in the Least Squares Means|||Day 4, Non-REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.43|-0.40|
71125196|NCT01300455|141756614|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.18|||||TWO_SIDED|90.0|-0.61|0.25|||Difference in the Least Squares Means|||Day 4, Wake, Difference (Suvorexant - Placebo) of Least Squares Means||0.25|-0.61|
71125197|NCT01300455|141756615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||||TWO_SIDED|90.0|-3.2|2.26|||Difference of Least Squares Means|||Difference (Suvorexant - Placebo) of Least Squares Means||2.26|-3.20|
71125198|NCT03002454|141756697|EQUIVALENCE|"Control: 99mTc MDP Injection:fission Investigation: 99mTc MDP Injection:neutron-bombardment~Anticipated sample size of 50 participants with sample size parameters of:~Alpha 0.05 Power 80% Kappa of significance 0.7 - 0.8 Prevalence of abnormal bone scans 30%~Actual study population of 4 participants with 4 out of 4 demonstrating gross abnormal biodistribution therefore the study was terminated and no statistical analysis was conducted."|||||||||||||||||No statistical analysis - insufficient study population|||
71125199|NCT00552409|141756706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.0|||||TWO_SIDED|95.0|-56.0|251.0|||Regression, Linear||Mean urine ACR on treatment was 17% lower among participants assigned to cholecalciferol, compared to participants assigned to placebo, adjusted for baseline values.|||251|-56|
71125200|NCT02228096|141756734|OTHER||||||<|0.0001|||||||Clopper-Pearson|||||||<0.0001
71125201|NCT00849108|141756855|SUPERIORITY_OR_OTHER||sensitivity|0.769||||0.02|TWO_SIDED|95.0|0.655|0.884||P-Value for sensitivity comparison of PET MPI for the same reader|McNemar|two-sided McNemar test with 1 degree of freedom.|No standard deviation can be calculated for PET sensitivity|||0.884|0.655|0.02
71125202|NCT00849108|141756855|SUPERIORITY_OR_OTHER||Sensitivity|0.596||||0.02|TWO_SIDED|95.0|0.463|0.73||p-value for sensitivity comparison for SPECT MPI for the same reader|McNemar||No standard deviation can be calculated for SPECT sensitivity|||0.730|0.463|0.02
71125203|NCT00849108|141756857|SUPERIORITY_OR_OTHER||PET specificity|0.877||||0.317|TWO_SIDED|95.0|0.801|0.952||p-value for comparison of PET specificity for same reader|McNemar||no standard deviation for PET specficity|||0.952|0.801|0.317
71125204|NCT00849108|141756857|SUPERIORITY_OR_OTHER||SPECT specificity|0.836||||0.317|TWO_SIDED|95.0|0.751|0.921||p-value for comparison of SPECT specificity for same reader|McNemar||no standard deviation for SPECT specificity|||0.921|0.751|0.317
71125205|NCT01563172|141756859|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|6.95||||0.0008|TWO_SIDED|95.0|2.91|10.98||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from Analysis of variance (ANOVA) with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||10.98|2.91|0.0008
71125206|NCT01563172|141756860|SUPERIORITY_OR_OTHER||LS mean difference|5.7||||0.0049|TWO_SIDED|95.0|1.74|9.66||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||9.66|1.74|0.0049
71125207|NCT01563172|141756861|SUPERIORITY_OR_OTHER||LS mean difference|-10.86|||<|0.0001|TWO_SIDED|95.0|-14.77|-6.94||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||-6.94|-14.77|<0.0001
71125208|NCT01563172|141756862|SUPERIORITY_OR_OTHER||LS mean difference|-9.61|||<|0.0001|TWO_SIDED|95.0|-13.68|-5.54||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||-5.54|-13.68|<0.0001
71125209|NCT01563172|141756863|SUPERIORITY_OR_OTHER||LS mean difference|15.38|||<|0.0001|TWO_SIDED|95.0|11.45|19.31||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||19.31|11.45|<0.0001
71125210|NCT01563172|141756864|SUPERIORITY_OR_OTHER||LS Mean Difference|514.01|||<|0.0001|TWO_SIDED|95.0|283.02|744.99||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||744.99|283.02|<0.0001
70945753|NCT02447432|141392555|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.09|||||TWO_SIDED|95.0|0.89|1.33||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-1 serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.33|0.89|
70945754|NCT02447432|141392555|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|0.92|||||TWO_SIDED|95.0|0.75|1.12||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-4 serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.12|0.75|
70945755|NCT02447432|141392555|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.03|||||TWO_SIDED|95.0|0.85|1.26||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-5 serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.26|0.85|
70945756|NCT02447432|141392555|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.12|||||TWO_SIDED|95.0|0.78|1.61||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-6B serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.61|0.78|
70945757|NCT02447432|141392555|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.05|||||TWO_SIDED|95.0|0.88|1.25||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-7F serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.25|0.88|
70954328|NCT03843554|141411198|SUPERIORITY|OMDP-STANDARD|Mean Difference (Final Values)|0.0569|STANDARD_ERROR_OF_MEAN|0.116||0.6263|TWO_SIDED|95.0|-0.1755|0.2893||A Week 8 general linear mixed effects model (GLM) was used to compare the change in saliva flow rate from Baseline (day 0) to week 8 (day 56) between the two groups. The change was calculated by subtracting week 8 saliva flow rate from the Baseline.|ANCOVA||Estimation of the difference in least-square means for the change from Baseline to FIV in saliva flow rate.|||0.2893|-0.1755|0.6263
71125211|NCT01563172|141756865|SUPERIORITY_OR_OTHER||LS Mean difference|265.92||||0.0218|TWO_SIDED|95.0|39.0|492.83||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||492.83|39.00|0.0218
71125212|NCT01563172|141756866|SUPERIORITY_OR_OTHER||LS mean difference|-822.88|||<|0.0001|TWO_SIDED|95.0|-1047.34|-598.42||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||-598.42|-1047.34|<0.0001
71125213|NCT01563172|141756867|SUPERIORITY_OR_OTHER||LS mean difference|-574.79|||<|0.0001|TWO_SIDED|95.0|-808.08|-341.5||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||-341.50|-808.08|<0.0001
71125214|NCT01563172|141756868|SUPERIORITY_OR_OTHER||LS mean difference|1294.34|||<|0.0001|TWO_SIDED|95.0|1069.24|1519.43||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||1519.43|1069.24|<0.0001
71125215|NCT02014584|141756887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0||||0.27|TWO_SIDED|95.0|-4.7|18.8|||Fisher's Exact Test|||||18.8|-4.7|0.27
71125216|NCT02014584|141756933|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.5||||0.62|TWO_SIDED|95.0|-10.4|3.4|||Fisher's Exact Test||DB Week 4|||3.4|-10.4|0.62
71125217|NCT02014584|141756933|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|6.4||||0.34|TWO_SIDED|95.0|-4.7|17.6|||Fisher's Exact Test||DB Week 12|||17.6|-4.7|0.34
71125218|NCT02014584|141756933|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|6.3||||0.31|TWO_SIDED|95.0|-4.2|16.7|||Fisher's Exact Test||DB Week 24|||16.7|-4.2|0.31
70857140|NCT02446743|141200512|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-6.8|8.9|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.9|-6.8|
70954329|NCT03843554|141411199|SUPERIORITY|OMDP-STANDARD|Mean Difference (Net)|-1.94||||0.6956|TWO_SIDED|95.0|||||Regression, Linear|A Week 8 (Day 56) GLM analyzing the pain change Week 8 relative to Baseline (Day 0) was used with treatment and Baseline pain as covariates.|Difference in least-square mean change from baseline to Visit 9 in pain score.|||||0.6956
71125219|NCT02014584|141756935|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.4|STANDARD_ERROR_OF_MEAN|0.8||0.082|TWO_SIDED|95.0|-0.2|3.0|||t-test from general linear model||DB Week 4|||3.0|-0.2|0.082
71125220|NCT02014584|141756935|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.3|STANDARD_ERROR_OF_MEAN|1.09||0.25|TWO_SIDED|95.0|-3.4|0.9|||t-test from general linear model||DB Week 12|||0.9|-3.4|0.25
71125221|NCT02014584|141756935|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|1.04||0.99|TWO_SIDED|95.0|-2.0|2.1|||t-test from general linear model||DB Week 24|||2.1|-2.0|0.99
70857141|NCT02446743|141200512|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|11.0|||||TWO_SIDED|95.0|5.3|16.9|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||16.9|5.3|
71125222|NCT02014584|141756937|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.33||0.46|TWO_SIDED|95.0|-0.4|0.9|||t-test from general linear model||Erectile Function DB Week 4|||0.9|-0.4|0.46
71125223|NCT02014584|141756937|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.52||0.14|TWO_SIDED|95.0|-1.8|0.3|||t-test from general linear model||Erectile Function DB Week 12|||0.3|-1.8|0.14
71125224|NCT02014584|141756937|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.61||0.27|TWO_SIDED|95.0|-1.9|0.5|||t-test from general linear model||Erectile Function DB Week 24|||0.5|-1.9|0.27
71125225|NCT02014584|141756937|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.23||0.13|TWO_SIDED|95.0|-0.1|0.8|||t-test from general linear model||Intercourse satisfaction DB Week 4|||0.8|-0.1|0.13
71125226|NCT02014584|141756937|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.33||0.73|TWO_SIDED|95.0|-0.8|0.5|||t-test from general linear model||Intercourse satisfaction DB Week 12|||0.5|-0.8|0.73
71125227|NCT02014584|141756937|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.34||0.64|TWO_SIDED|95.0|-0.8|0.5|||t-test from general linear model||Intercourse satisfaction DB Week 24|||0.5|-0.8|0.64
71087660|NCT01115452|141681486|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.36||||0.7318|TWO_SIDED|95.0|-9.18|6.46||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.46|-9.18|0.7318
71125228|NCT02014584|141756937|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.16||0.23|TWO_SIDED|95.0|-0.1|0.5|||t-test from general linear model||Orgasmic function DB Week 4|||0.5|-0.1|0.23
71125229|NCT02014584|141756937|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.33|TWO_SIDED|95.0|-0.5|0.2|||t-test from general linear model||Orgasmic function DB Week 12|||0.2|-0.5|0.33
71125230|NCT02014584|141756937|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.23||0.64|TWO_SIDED|95.0|-0.6|0.3|||t-test from general linear model||Orgasmic function DB Week 24|||0.3|-0.6|0.64
71125231|NCT02014584|141756937|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.19|TWO_SIDED|95.0|-0.1|0.7|||t-test from general linear model||Sexual desire DB Week 4|||0.7|-0.1|0.19
71125232|NCT02014584|141756937|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.22||0.28|TWO_SIDED|95.0|-0.7|0.2|||t-test from general linear model||Sexual desire DB Week 12|||0.2|-0.7|0.28
71125233|NCT02014584|141756937|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.27||1|TWO_SIDED|95.0|-0.5|0.5|||t-test from general linear model||Sexual desire DB Week 24|||0.5|-0.5|1.00
71125234|NCT02014584|141756937|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.17||0.28|TWO_SIDED|95.0|-0.2|0.5|||t-test from general linear model||Overall sexual satisfaction DB Week 4|||0.5|-0.2|0.28
71125235|NCT02014584|141756937|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.64|TWO_SIDED|95.0|-0.5|0.3|||t-test from general linear model||Overall sexual satisfaction DB Week 12|||0.3|-0.5|0.64
71125236|NCT02014584|141756937|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.22||0.69|TWO_SIDED|95.0|-0.5|0.3|||t-test from general linear model||Overall sexual satisfaction DB Week 24|||0.3|-0.5|0.69
71125237|NCT02014584|141756939|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.1|STANDARD_ERROR_OF_MEAN|1.14||0.33|TWO_SIDED|95.0|-1.1|3.4|||t-test from general linear model||DB Week 12|||3.4|-1.1|0.33
71125238|NCT02014584|141756939|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.3|STANDARD_ERROR_OF_MEAN|1.14||0.004|TWO_SIDED|95.0|1.1|5.6|||t-test from general linear model||DB Week 24|||5.6|1.1|0.004
71125239|NCT02014584|141756941|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.51||0.22|TWO_SIDED|95.0|-1.7|0.4|||t-test from general linear model||DB Week 12|||0.4|-1.7|0.22
71125240|NCT02014584|141756941|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.76||0.5|TWO_SIDED|95.0|-2.0|1.0|||t-test from general linear model||DB Week 24|||1.0|-2.0|0.50
71125241|NCT01555125|141756945|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71125242|NCT01555125|141756945|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71125243|NCT01555125|141756946|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71125244|NCT01555125|141756946|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71125245|NCT02651220|141756968|EQUIVALENCE|Bioequivalence was based on 90% confidence interval within 80-125%.|Bioavailability|100.28|||||TWO_SIDED|90.0|96.78|103.91||||||||103.91|96.78|
71125246|NCT02651220|141756969|EQUIVALENCE|Bioequivalence is based on 90% confidence interval within 80-125%.|Bioavailability|99.73|||||TWO_SIDED|90.0|96.04|103.56||||||||103.56|96.04|
71125247|NCT02651220|141756970|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71125248|NCT00896441|141756971|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|One sample t-test||||||<0.01
71125249|NCT00896441|141756973|OTHER||||||<|0.006|||||||t-test, 2 sided|Single group t-test||||||<.006
71125250|NCT01304589|141756974|SUPERIORITY_OR_OTHER|||||||0.001||||||A paired T-Test was calculated assuming a standard difference (d) between the 4 paired outcomes for pain of 0.60 (moderate effect size), a SD of 1 for each outcome variable and a correlation of 0.50 between each paired variable.|t-test, 2 sided|||||||.001
71125251|NCT01304589|141756975|SUPERIORITY_OR_OTHER|||||||0.003||||||A paired T-Test was calculated assuming a standard difference (d) between the 4 paired outcomes for pain of 0.60 (moderate effect size), a SD of 1 for each outcome variable and a correlation of 0.50 between each paired variable.|paired T-test|"Subjects completed a tampon insertion pain test once a week. The values were averaged and compared pre-treatment versus post-treatment."||||||.003
71125252|NCT01304589|141756976|SUPERIORITY_OR_OTHER|||||||0.001||||||A paired T-Test was calculated assuming a standard difference (d) between the 4 paired outcomes for pain of 0.60 (moderate effect size), a SD of 1 for each outcome variable and a correlation of 0.50 between each paired variable.|t-test, 2 sided|||||||.001
71125253|NCT01304589|141756977|SUPERIORITY_OR_OTHER||||||<|0.001||||||A paired T-Test was calculated assuming a standard difference (d) between the 4 paired outcomes for pain of 0.60 (moderate effect size), a SD of 1 for each outcome variable and a correlation of 0.50 between each paired variable.|t-test, 2 sided|||||||<.001
71125254|NCT00279812|141756980|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71125255|NCT00279812|141756981|OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71125256|NCT00279812|141756982|OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71087661|NCT01115452|141681486|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.05||||0.7949|TWO_SIDED|95.0|-6.93|9.03||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||9.03|-6.93|0.7949
71087662|NCT01115452|141681486|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.41||||0.5507|TWO_SIDED|95.0|-5.56|10.37||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||10.37|-5.56|0.5507
71125257|NCT01439373|141757027|OTHER||Mean posterior difference|0.46|STANDARD_DEVIATION|0.119|||||||||Bayesian probability model|"P1= P(p805 \>pPLC +0.3 \| data)= 0.905. A probability of 95% (P1 \> 0.95) or greater was to be considered 'substantial evidence of superiority."|Posterior Distribution of Difference= p805 - pPLC, where, p805 is the RVR rate for GSK2336805 and pPLC is the RVR rate for Placebo. 95% credible set was defined as the 2.5 and 97.5 percentiles. 95% credible interval for the estimate was 0.22 to 0.68.|||||
70857142|NCT02446743|141200512|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-2.0|||||TWO_SIDED|95.0|-18.0|14.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||14.1|-18.0|
70857143|NCT02446743|141200512|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-9.7|15.7|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||15.7|-9.7|
70857144|NCT02446743|141200512|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|17.0|||||TWO_SIDED|95.0|8.2|27.8|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||27.8|8.2|
70857145|NCT02446743|141200512|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-6.0|||||TWO_SIDED|95.0|-19.1|9.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||9.1|-19.1|
70857146|NCT02446743|141200512|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-8.4|11.8|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||11.8|-8.4|
70857147|NCT02446743|141200512|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|6.0|||||TWO_SIDED|95.0|-0.47|12.6|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||12.6|-0.47|
71125258|NCT01439373|141757028|OTHER||Mean posterior difference|0.41|STANDARD_DEVIATION|0.122|||||||||Bayesian probability model|"P1= P(p805 \>pPLC +0.3 \| data)= 0.822. A probability of 95% (P1 \> 0.95) or greater was to be considered 'substantial evidence of superiority."|Posterior Distribution of Difference= p805 - pPLC, where, p805 is the RVR rate for GSK2336805 and pPLC is the RVR rate for Placebo. 95% credible set was defined as the 2.5 and 97.5 percentiles. 95% credible interval for the estimate was 0.17 to 0.6|||||
70857148|NCT02446743|141200513|OTHER|Vaccine Comparison Day 31 Group 3B vs Day 61 Group B\_0\_1(1 month after booster or 2nd dose)|Ratio of GMTs|3.49|||||TWO_SIDED|95.0|2.85|4.29|||ANOVA|||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||4.29|2.85|
70945758|NCT02447432|141392555|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|0.88|||||TWO_SIDED|95.0|0.69|1.13||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-9V serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.13|0.69|
70945759|NCT02447432|141392555|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|0.98|||||TWO_SIDED|95.0|0.73|1.31||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-14 serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.31|0.73|
70945760|NCT02447432|141392555|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.08|||||TWO_SIDED|95.0|0.86|1.37||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-18C serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.37|0.86|
70945761|NCT02447432|141392555|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|0.99|||||TWO_SIDED|95.0|0.78|1.25||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-19F serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.25|0.78|
70945762|NCT02447432|141392555|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.28|||||TWO_SIDED|95.0|0.92|1.8||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-23F serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.80|0.92|
70954330|NCT03843554|141411200|SUPERIORITY|OMDP-STANDARD|Mean Difference (Final Values)|-0.188|STANDARD_ERROR_OF_MEAN|0.113||0.1153|TWO_SIDED|95.0|-0.4095|0.0334|||ANCOVA|ANCOVA via generalized linear mixed repeated measures model (GLMER)||The statistical analysis comprised an ANCOVA for a longitudinal response based on a generalized linear mixed effects repeated measures model (GLMER). The response variable is the mean change from Baseline to Visit 9 in EORTC QLQ-C30 Questions 31-48 (total).||0.0334|-0.4095|0.1153
71087663|NCT01115452|141681487|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.72||||0.8549|TWO_SIDED|95.0|-8.54|7.1||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Investigator applied the participants with 5% potassium nitrate solution on each of the three individual sensitive tooth for two minutes (mins), in each of the five day treatment period|Null hypothesis is no difference between treatments.||7.10|-8.54|0.8549
71125259|NCT03281304|141757046|OTHER||Adjusted (weighted) difference|12.9|||||TWO_SIDED|95.0|0.5|25.0||||||Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||25.0|0.5|
71125260|NCT03281304|141757048|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-7.5|13.4||||||Month 1: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||13.4|-7.5|
71125261|NCT03281304|141757048|OTHER||Adjusted (weighted) difference|11.4|||||TWO_SIDED|95.0|0.1|22.8||||||Month 3: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||22.8|0.1|
71125262|NCT03281304|141757048|OTHER||Adjusted (weighted) difference|14.3|||||TWO_SIDED|95.0|2.9|25.2||||||Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||25.2|2.9|
71087664|NCT01115452|141681487|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.15||||0.9705|TWO_SIDED|95.0|-8.13|7.83||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||7.83|-8.13|0.9705
71087665|NCT01115452|141681487|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.57||||0.8867|TWO_SIDED|95.0|-7.39|8.54||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||8.54|-7.39|0.8867
71087666|NCT00678418|141681527|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Van der Waerden|||Null hypothesis = the distribution function of opioid-free weeks is the same for both treatment groups.||||0.0002
71087667|NCT00678418|141681528|SUPERIORITY_OR_OTHER|||||||0.0042||95.0||||A total of 114 subjects continued on-study beyond the 168-day endpoint for Part A; these subjects were censored as of the first dosing day in Part B.|Kaplan Meier|||P-value was calculated using the log-rank test for the null hypothesis: the distribution of days to discontinuation does not differ by treatment.||||0.0042
71125263|NCT03281304|141757048|OTHER||Adjusted (weighted) difference|20.0|||||TWO_SIDED|95.0|8.0|31.8||||||Month 9: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||31.8|8.0|
71125264|NCT03281304|141757048|OTHER||Adjusted (weighted) difference|15.7|||||TWO_SIDED|95.0|2.2|28.7||||||Month 12: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||28.7|2.2|
71125265|NCT03281304|141757048|OTHER||Adjusted (weighted) difference|14.3|||||TWO_SIDED|95.0|0.0|27.9||||||Month 15: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||27.9|0.0|
71125266|NCT03281304|141757048|OTHER||Adjusted (weighted) difference|14.3|||||TWO_SIDED|95.0|-0.7|28.5||||||Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||28.5|-0.7|
71125267|NCT03281304|141757048|OTHER||Adjusted (weighted) difference|7.1|||||TWO_SIDED|95.0|-8.0|21.9||||||Month 21: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||21.9|-8.0|
71125268|NCT03281304|141757048|OTHER||Adjusted (weighted) difference|5.7|||||TWO_SIDED|95.0|-9.3|20.4||||||Month 24: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||20.4|-9.3|
71125269|NCT03281304|141757048|OTHER||Adjusted (weighted) difference|8.6|||||TWO_SIDED|95.0|-7.0|23.6||||||Month 27: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||23.6|-7.0|
71125270|NCT03281304|141757048|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-12.8|18.3||||||Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||18.3|-12.8|
70945763|NCT04198948|141392572|EQUIVALENCE|Sample size calculation was performed using SAS Proc Power procedure for equivalence test in 2x2 crossover design. For an equivalence range of 80-125%, the within-subject coefficient of variation for the AUC values for gliclazide of 7.8% based on previous PK studies, and expected test/reference geometric mean ratios between 87-115%, 14 volunteers (7 individuals per sequence) are required to show the lack of interaction with 85% power.|Geometric least square mean ratio|1.13|||||TWO_SIDED|90.0|0.86|1.48|||||The TOST (two one-sided test) test of equivalence showed that the geometric mean ratio and 90% CI for gliclazide AUC(0-24) between omeprazole and placebo phase was 1.13 (0.86-1.48), with upper confidence limit above the usual 1.25 boundary.|The main evaluated outcome was systemic exposure to gliclazide, expressed as AUC(0-t). The geometric mean was calculated for gliclazide AUC(0-24). The ratio of the geometric means with 90% CIs was assessed by linear mixed models between the two treatment assignments: gliclazide and omeprazole co-administration to that of gliclazide and placebo. The obtained 90% CI was compared with the equivalence 0.8-1.25 range.||1.48|0.86|
70945764|NCT04198948|141392573|SUPERIORITY|||||||0.636|||||||t-test, 2 sided|||||||0.636
70945765|NCT04198948|141392574|SUPERIORITY|||||||0.055|||||||t-test, 2 sided|||||||0.055
70945766|NCT00913068|141392576|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012||95.0|||||Chi-squared|||||||0.0012
70945767|NCT00726713|141392584|SUPERIORITY_OR_OTHER||||||=|0.013|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Change from Baseline, Week 16||||=0.013
70945768|NCT00726713|141392584|SUPERIORITY_OR_OTHER||||||=|0.033|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Change from Baseline, Week 24||||=0.033
70945769|NCT00726713|141392585|SUPERIORITY_OR_OTHER||||||=|0.027|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Change from Baseline, Week 16||||=0.027
70945770|NCT00726713|141392586|SUPERIORITY_OR_OTHER||||||=|0.0001||||||Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes|Mixed Models Analysis|||Total Folate, Change from BL, Week 16||||=0.0001
70945771|NCT00726713|141392586|SUPERIORITY_OR_OTHER||||||=|0.0001||||||Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes|Mixed Models Analysis|||Total Folate, Change from BL, Week 24||||=0.0001
70945772|NCT00726713|141392586|SUPERIORITY_OR_OTHER||||||=|0.0001|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Total MMA, Change from Baseline Week 16||||=0.0001
70945773|NCT00726713|141392586|SUPERIORITY_OR_OTHER||||||=|0.0008|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Total MMA, Change from BL, Week 24||||=0.0008
71125271|NCT03281304|141757048|OTHER||Adjusted (weighted) difference|1.4|||||TWO_SIDED|95.0|-14.4|17.2||||||Month 33: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||17.2|-14.4|
71125272|NCT03281304|141757048|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-13.0|18.5||||||Month 36: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||18.5|-13.0|
70945774|NCT00726713|141392586|SUPERIORITY_OR_OTHER||||||=|0.0001||||||Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes|Mixed Models Analysis|||Total Homocysteine, Change from BL, Week 16||||=0.0001
70945775|NCT00726713|141392586|SUPERIORITY_OR_OTHER||||||=|0.0001|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Total Homocysteine, Change from BL, Week 24||||=0.0001
70945776|NCT00726713|141392587|SUPERIORITY_OR_OTHER||||||=|0.0306||||||Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes|Mixed Models Analysis|||SF-36 MCS, Change from BL, Week 24||||=0.0306
70945777|NCT00726713|141392590|SUPERIORITY_OR_OTHER||||||=|0.054|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||HADS Depression, Change from BL, Week 24||||=0.054
70945778|NCT02367105|141392595|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.58|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariate||||||0.58
70945779|NCT02367105|141392596|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.03|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.03
70945780|NCT02367105|141392597|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.97|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||.97
70945781|NCT02367105|141392598|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.56|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.56
70945782|NCT02367105|141392599|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.01
70945783|NCT02367105|141392600|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.91|TWO_SIDED||||||Mixed Models Analysis|||||||0.91
70945784|NCT02367105|141392601|SUPERIORITY||Mean Difference (Final Values)|-42.0||||0.04|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.04
70945785|NCT02367105|141392602|SUPERIORITY||Mean Difference (Final Values)|-29.0||||0.67|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariates||||||.67
70945786|NCT02367105|141392603|SUPERIORITY||Mean Difference (Final Values)|-0.019||||0.003|TWO_SIDED||||||Mixed Models Analysis|Baseline valued adjusted||||||0.003
70945787|NCT02367105|141392604|SUPERIORITY||Mean Difference (Final Values)|-0.003||||0.69|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.69
70945788|NCT02367105|141392605|SUPERIORITY||Mean Difference (Final Values)|7.0||||0.94|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.94
70945789|NCT02367105|141392606|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.41|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.41
70945790|NCT02367105|141392607|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.46|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariates||||||0.46
71125273|NCT03281304|141757048|OTHER||Adjusted (weighted) difference|-4.3|||||TWO_SIDED|95.0|-20.2|11.9||||||Month 39: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||11.9|-20.2|
71125274|NCT03281304|141757048|OTHER||Adjusted (weighted) difference|4.3|||||TWO_SIDED|95.0|-11.7|19.9||||||Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||19.9|-11.7|
71125275|NCT03281304|141757049|OTHER||Adjusted (weighted) difference|11.4|||||TWO_SIDED|95.0|-1.5|24.1||||||Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||24.1|-1.5|
70857149|NCT02446743|141200513|OTHER|Vaccine Comparison Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|Ratio of GMTs|2.73|||||TWO_SIDED|95.0|2.02|3.69|||ANOVA|||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||3.69|2.02|
70945791|NCT02367105|141392608|SUPERIORITY|Baseline value adjusted|Mean Difference (Final Values)|0.6||||0.96|TWO_SIDED||||||Mixed Models Analysis|||||||0.96
70857150|NCT02446743|141200513|OTHER|Vaccine Comparison Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|Ratio of GMTs|4.46|||||TWO_SIDED|95.0|3.38|5.88|||ANOVA|||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||5.88|3.38|
70857151|NCT02446743|141200513|OTHER|Vaccine Comparison Day 31 Group 3B vs Day 61 Group B\_0\_1(1 month after booster or 2nd dose)|Ratio of GMTs|8.18|||||TWO_SIDED|95.0|6.51|10.0|||ANOVA|||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||10|6.51|
70857152|NCT02446743|141200513|OTHER|Vaccine Comparison Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|Ratio of GMTs|9.58|||||TWO_SIDED|95.0|7.17|13.0|||ANOVA|||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||13|7.17|
70857153|NCT02446743|141200513|OTHER|Vaccine Comparison Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|Ratio of GMTs|6.9|||||TWO_SIDED|95.0|4.82|9.87|||ANOVA|||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||9.87|4.82|
70857154|NCT02446743|141200513|OTHER|Vaccine Comparison Day 31 Group 3B vs Day 61 Group B\_0\_1(1 month after booster or 2nd dose)|Ratio of GMTs|2.58|||||TWO_SIDED|95.0|1.98|3.36|||ANOVA|||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||3.36|1.98|
70857155|NCT02446743|141200513|OTHER|Vaccine Comparison Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|Ratio of GMTs|2.65|||||TWO_SIDED|95.0|1.89|3.73|||ANOVA|||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||3.73|1.89|
71125276|NCT03281304|141757049|OTHER||Adjusted (weighted) difference|20.0|||||TWO_SIDED|95.0|3.6|35.0||||||Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||35.0|3.6|
71125277|NCT03281304|141757049|OTHER||Adjusted (weighted) difference|12.9|||||TWO_SIDED|95.0|-3.5|28.3||||||Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||28.3|-3.5|
71125278|NCT03281304|141757049|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-12.5|18.0||||||Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||18.0|-12.5|
71125279|NCT03281304|141757050|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-7.5|13.4||||||Month 1: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||13.4|-7.5|
71125280|NCT03281304|141757050|OTHER||Adjusted (weighted) difference|11.4|||||TWO_SIDED|95.0|0.1|22.8||||||Month 3: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||22.8|0.1|
71125281|NCT03281304|141757050|OTHER||Adjusted (weighted) difference|14.3|||||TWO_SIDED|95.0|2.4|25.6||||||Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||25.6|2.4|
71125282|NCT03281304|141757050|OTHER||Adjusted (weighted) difference|20.0|||||TWO_SIDED|95.0|8.0|31.8||||||Month 9: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||31.8|8.0|
71125283|NCT03281304|141757050|OTHER||Adjusted (weighted) difference|15.7|||||TWO_SIDED|95.0|2.2|28.7||||||Month 12: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||28.7|2.2|
71125284|NCT03281304|141757050|OTHER||Adjusted (weighted) difference|14.3|||||TWO_SIDED|95.0|0.0|27.9||||||Month 15: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||27.9|0.0|
71125285|NCT03281304|141757050|OTHER||Adjusted (weighted) difference|15.7|||||TWO_SIDED|95.0|0.7|29.9||||||Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||29.9|0.7|
71125286|NCT03281304|141757050|OTHER||Adjusted (weighted) difference|5.7|||||TWO_SIDED|95.0|-9.5|20.6||||||Month 21: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||20.6|-9.5|
71125287|NCT03281304|141757050|OTHER||Adjusted (weighted) difference|7.1|||||TWO_SIDED|95.0|-8.0|21.9||||||Month 24: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||21.9|-8.0|
71125288|NCT03281304|141757050|OTHER||Adjusted (weighted) difference|10.0|||||TWO_SIDED|95.0|-5.7|25.1||||||Month 27: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||25.1|-5.7|
71125289|NCT03281304|141757050|OTHER||Adjusted (weighted) difference|4.3|||||TWO_SIDED|95.0|-11.4|19.7||||||Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||19.7|-11.4|
71125290|NCT03281304|141757050|OTHER||Adjusted (weighted) difference|1.4|||||TWO_SIDED|95.0|-14.4|17.2||||||Month 33: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||17.2|-14.4|
71125291|NCT03281304|141757050|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-13.0|18.5||||||Month 36: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||18.5|-13.0|
71125292|NCT03281304|141757050|OTHER||Adjusted (weighted) difference|-2.9|||||TWO_SIDED|95.0|-18.8|13.3||||||Month 39: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||13.3|-18.8|
70857156|NCT02446743|141200513|OTHER|Vaccine Comparison Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|Ratio of GMTs|2.51|||||TWO_SIDED|95.0|1.67|3.78|||ANOVA|||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||3.78|1.67|
70945792|NCT02367105|141392609|SUPERIORITY||Mean Difference (Final Values)|-0.284||||0.003|TWO_SIDED||||||Mixed Models Analysis|||||||.003
70945793|NCT02367105|141392610|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.16|TWO_SIDED||||||Mixed Models Analysis|Baseline value and years of education as covariates||||||.16
71125293|NCT03281304|141757050|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-13.0|18.5||||||Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||18.5|-13.0|
71125294|NCT03281304|141757051|OTHER||Adjusted (weighted) difference|15.7|||||TWO_SIDED|95.0|-0.4|30.8||||||Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||30.8|-0.4|
71125295|NCT03281304|141757051|OTHER||Adjusted (weighted) difference|12.9|||||TWO_SIDED|95.0|-3.5|28.3||||||Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||28.3|-3.5|
71125296|NCT03281304|141757051|OTHER||Adjusted (weighted) difference|1.4|||||TWO_SIDED|95.0|-14.0|16.7||||||Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||16.7|-14.0|
71125297|NCT03281304|141757052|OTHER||Mean Difference|-0.3|||||TWO_SIDED|95.0|-0.8|0.1||||||||0.1|-0.8|
71125298|NCT03281304|141757054|OTHER||Least Squares (LS) Mean Difference|0.1|||||TWO_SIDED|95.0|-0.1|0.3||||||Month 1||0.3|-0.1|
71125299|NCT03281304|141757054|OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.2|0.2||||||Month 3||0.2|-0.2|
71125300|NCT03281304|141757054|OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.2|0.3||||||Month 6||0.3|-0.2|
71125301|NCT03281304|141757056|OTHER||LS Mean Difference|-0.6|||||TWO_SIDED|95.0|-1.2|0.1||||||||0.1|-1.2|
71125302|NCT03281304|141757058|OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.3|0.3||||||Month 1||0.3|-0.3|
71125303|NCT03281304|141757058|OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.3|0.2||||||Month 3||0.2|-0.3|
71125304|NCT03281304|141757058|OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.3|0.3||||||Month 6||0.3|-0.3|
71125305|NCT03281304|141757060|OTHER||Adjusted (weighted) difference|11.4|||||TWO_SIDED|95.0|-0.3|23.1||||||Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||23.1|-0.3|
71125306|NCT03281304|141757060|OTHER||Adjusted (weighted) difference|18.6|||||TWO_SIDED|95.0|3.5|32.6||||||Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||32.6|3.5|
71125307|NCT03281304|141757060|OTHER||Adjusted (weighted) difference|12.9|||||TWO_SIDED|95.0|-3.3|28.1||||||Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||28.1|-3.3|
71125308|NCT03281304|141757060|OTHER||Adjusted (weighted) difference|0.0|||||TWO_SIDED|95.0|-16.1|16.1||||||Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||16.1|-16.1|
71125309|NCT03281304|141757061|OTHER||Adjusted (weighted) difference|11.4|||||TWO_SIDED|95.0|1.3|22.0||||||Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||22.0|1.3|
71125310|NCT03281304|141757061|OTHER||Adjusted (weighted) difference|11.4|||||TWO_SIDED|95.0|-4.2|26.4||||||Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||26.4|-4.2|
71125311|NCT03281304|141757061|OTHER||Adjusted (weighted) difference|10.0|||||TWO_SIDED|95.0|-5.8|25.2||||||Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||25.2|-5.8|
71125312|NCT03281304|141757061|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-13.0|18.5||||||Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||18.5|-13.0|
70945794|NCT02367105|141392611|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.21|TWO_SIDED||||||Mixed Models Analysis|Baseline values and years of education as covariates||||||0.21
70945795|NCT02367105|141392612|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.41|TWO_SIDED||||||Mixed Models Analysis|Baseline values and years of education as covariates||||||0.41
70945796|NCT02367105|141392613|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.03|TWO_SIDED||||||Mixed Models Analysis|Baseline value and years if education as covariates||||||.03
71125313|NCT02020408|141757088|SUPERIORITY||||||>|0.05||||||The p value was calculated and adjusted for multiple comparisons (Bonferroni).|ANOVA|||||||> 0.05
71125314|NCT02020408|141757089|SUPERIORITY||||||<|0.05||||||The p value was calculated and adjusted for multiple comparisons (Bonferroni).|General Linear Model|||A General Linear Model using log(\[11C\]raclopride BPND) after amphetamine administration as dependent variable and Diagnostic Group as independent variable was used. Baseline (before amphetamine administration) \[11C\]raclopride BPND was used as covariate.||||<0.05
71125315|NCT02720692|141757093|SUPERIORITY||||||<|0.05||||||P\<0.05 applies to Day 1 (0-24 Hours; p=0.0033), Days 1-2 (0-48 Hours; p=0.0077), and Days 1-3 (0-72 Hours; p=0.0152).|ANCOVA|||||||<0.05
71125316|NCT05011513|141757094|SUPERIORITY|||||||0.6027|||||||Log Rank|||||||0.6027
71125317|NCT05011513|141757096|SUPERIORITY|||||||0.1796||||||P-value reported for COVID-19 hospitalization and death due to any cause.|Normal approximation|||||||0.1796
71125318|NCT05011513|141757098|SUPERIORITY|||||||0.0971|||||||Negative binomial|||||||0.0971
71125319|NCT05011513|141757100|SUPERIORITY||Odds Ratio (OR)|0.819||||0.1622|TWO_SIDED|95.0|0.618|1.084|||Regression, Logistic|||Main effects of treatment, geographic region, baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.084|0.618|0.1622
71125320|NCT05011513|141757101|SUPERIORITY|||||||0.4298|||||||Log Rank|||||||0.4298
71125321|NCT05011513|141757104|SUPERIORITY||Odds Ratio (OR)|0.802||||0.1086|TWO_SIDED|95.0|0.613|1.05|||Regression, Logistic|||Main effects of treatment, geographic region, symptom onset duration (\<=3, \>3), baseline SARS-CoV-2 serology status (positive/negative), vaccination status (complete/not vaccinated) and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL).||1.050|0.613|0.1086
71125322|NCT05011513|141757105|SUPERIORITY||Odds Ratio (OR)|50.333||||0.3262|TWO_SIDED|95.0|13.163|192.472|||Breslow-Day Test|||||192.472|13.163|0.3262
71125323|NCT05011513|141757105|SUPERIORITY||Odds Ratio (OR)|22.224|||||TWO_SIDED|95.0|8.36|59.08||||||Odds ratio for Day 5 vs Day 1||59.080|8.360|
71125324|NCT03878758|141757109|SUPERIORITY|The average difference in incidence of needle bending with BD Nano vs. Comparator pen needle was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|-0.39||||0.591|TWO_SIDED|95.0|-1.82|1.04|||Fisher Exact|||||1.04|-1.82|0.591
70945797|NCT02367105|141392614|SUPERIORITY||Mean Difference (Final Values)|6.6||||0.03|TWO_SIDED||||||Mixed Models Analysis|Baseline values and years of education as covariates||||||.03
70945798|NCT02367105|141392615|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.18|TWO_SIDED||||||Mixed Models Analysis|Baseline values and years of education as covariates||||||.18
70945799|NCT02367105|141392616|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.1|TWO_SIDED||||||Mixed Models Analysis|Baseline values and years of education as covariates||||||0.10
70945800|NCT02367105|141392617|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.65|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariates||||||.65
70945801|NCT02367105|141392618|SUPERIORITY||Mean Difference (Final Values)|0.553||||0.03|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.03
70945802|NCT02367105|141392619|SUPERIORITY||Mean Difference (Final Values)|-6.5||||0.04|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.04
70945803|NCT02367105|141392620|SUPERIORITY||Mean Difference (Final Values)|5.5||||0.35|TWO_SIDED|||||Baseline value adjusted|Mixed Models Analysis|||||||0.35
71125325|NCT03878758|141757109|SUPERIORITY|The average difference in percentage of occurrence with BD Nano vs. Comparator pen needle was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|0.13||||0.931|TWO_SIDED|95.0|-2.8|3.06|||Fisher Exact|||||3.06|-2.8|0.931
71125326|NCT03878758|141757109|SUPERIORITY|The average difference in percentage of occurrence with BD Nano vs. Comparator pen needle was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|0.42||||0.723|TWO_SIDED|95.0|-1.91|2.75|||Fisher Exact|||||2.75|-1.91|0.723
71125327|NCT03878758|141757110|SUPERIORITY|The average difference in percentage of occurrence with BD Nano vs. comparator was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|-5.7|||<|0.001|TWO_SIDED|95.0|-9.0|-3.5|||Fisher Exact|||||-3.5|-9.0|<0.001
71125328|NCT03878758|141757110|SUPERIORITY|The average difference in percentage of occurrence with BD Nano vs. comparator was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|-14.09||||0.026|TWO_SIDED|95.0|-26.49|-1.69||Although a site difference was detected - all sites combined p-value was generated,|Fisher Exact|||||-1.69|-26.49|0.026
71125329|NCT03878758|141757110|SUPERIORITY|The average difference in percentage of occurrence with BD Nano vs.Comparator pen needle was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|-0.2||||0.644|TWO_SIDED|95.0|-1.9|0.6|||Fisher Exact|||||0.6|-1.9|0.644
71125330|NCT03878758|141757111|SUPERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates.|Overall Mean|0.8|||||TWO_SIDED|95.0|0.62|0.98||||||||0.98|0.62|
71125331|NCT03878758|141757111|SUPERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates.|Overall Mean|1.0|||||TWO_SIDED|95.0|0.8|1.16||||||||1.16|0.8|
71125332|NCT03878758|141757111|SUPERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates.|Overall Mean|0.3|||||TWO_SIDED|95.0|0.13|0.49||||||||0.49|0.13|
71125333|NCT03878758|141757112|SUPERIORITY|A mixed effect model was used (fixed effects of PN, abdomen site, order of pair, order of PN within pair and random subject effect) to estimate average difference (BD Nano PN - Comparator PN) in delivery time and total injection time. A Box-Cox transformation might be used to normalize the data if necessary.|Mean Difference (Final Values)|-0.192|||<|0.001|ONE_SIDED|95.0||-0.141|||Mixed Models Analysis|||BD Nano Pro vs Artsana 34G||-0.141||<0.001
71125334|NCT03878758|141757112|SUPERIORITY|A mixed effect model was used (fixed effects of PN, abdomen site, order of pair, order of PN within pair and random subject effect) to estimate average difference (BD Nano PN - Comparator PN) in delivery time and total injection time. A Box-Cox transformation might be used to normalize the data if necessary.|Mean Difference (Final Values)|-0.122||||0.104|ONE_SIDED|95.0||0.016|||Mixed Models Analysis|||BD NANO vs Artsana 33G. A significant site effect was detected at one site; the most conservative p-value is reported.||0.016||0.104
71125335|NCT03878758|141757112|SUPERIORITY|A mixed effect model was used (fixed effects of PN, abdomen site, order of pair, order of PN within pair and random subject effect) to estimate average difference (BD Nano PN - Comparator PN) in delivery time and total injection time. A Box-Cox transformation might be used to normalize the data if necessary. The upper bound of the confidence interval was compared to 0.|Mean Difference (Net)|-0.068||||0.003|ONE_SIDED|95.0||-0.017|||Mixed Models Analysis|||BD NANO vs Comfort EZ 33G||-0.017||0.003
71125336|NCT03878758|141757113|SUPERIORITY|The number and proportion of needle breaking occurrence for each pen needle type were summarized. A 95% confidence interval for difference in proportions between BD Nano Pro and the Comparator was calculated using the score method for independent proportions.|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.4|1.2||||||||1.2|-0.4|
71125337|NCT03878758|141757113|SUPERIORITY|The number and proportion of needle breaking occurrence for each pen needle type were summarized. A 95% confidence interval for difference in proportions between BD Nano Pro and the Comparator was calculated using the score method for independent proportions.|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.4|1.2||||||||1.2|-0.4|
71125338|NCT03878758|141757113|SUPERIORITY|The number and proportion of needle breaking occurrence for each pen needle type were summarized. A 95% confidence interval for difference in proportions between BD Nano Pro and the Comparator was calculated using the score method for independent proportions.|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.4|1.2||||||||1.2|-0.4|
71125339|NCT02100969|141757128|SUPERIORITY||"proportion of successes"|0.864||||0.0179|TWO_SIDED|95.0|0.72|1.0||No adjustment is required as we are not doing multiple comparisons for the primary outcome analyses.|One sample Z test of proportions||One sample Z test of proportions is used. Method of handling missing data (as per protocol) is Last Observation Carried Forward (LOCF). Only 2 participants had missing values and in our case the LOCF results reflect a 'best-case' scenario.|"Sample size/power calculations are mentioned in the study protocol.~The study hypotheses are as follows:~H0: Proportion of patients whose QMG scores are increased by no more than 3 points at the end of the SCIg treatment phase ≤ 0.65 HA: Proportion of patients whose QMG scores are increased by no more than 3 points at the end of the SCIg treatment phase \> 0.65"||1.000|0.720|0.0179
71125340|NCT02100969|141757129|SUPERIORITY||Median Difference (Net)|0.0||||0.113|TWO_SIDED||||||Wilcoxon Signed Rank for paired data||The value of the signed rank test statistic is 44.50.|||||0.113
71087668|NCT00678418|141681529|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Chi-squared|||"P-value was calculated using the Chi-square test for the null hypothesis: mean treatment difference = 0.~Calculations were based on the Generalized Estimating Equation (GEE) model (normal distribution, identity link and AR(1) correlation structure) for repeated data on change from baseline with treatment and visit as main effects, and baseline as a covariate. Missing data were imputed using the Last Observation Carried Forward (LOCF) method."||||<0.0001
71087669|NCT00678418|141681530|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75||||0.0154||95.0|0.6|0.95|||Chi-squared|||"Chi-square test was used to calculate the p-value for treatment. Null hypothesis = no association between relapse to dependence and study treatment.~Subjects who discontinued prematurely from the study were imputed as having a positive naloxone challenge test result."||0.95|0.60|0.0154
71087670|NCT00678418|141681531|SUPERIORITY_OR_OTHER|||||||0.0031||95.0|||||van der Waerden|||Null hypothesis: Treatment difference=0. Missing data from subjects due to early discontinuation during Part A were imputed using the baseline rate; thus data for subjects who discontinued early were imputed as having no change from baseline.||||0.0031
71125341|NCT02100969|141757130|SUPERIORITY||Median Difference (Net)|6.0||||0.612|TWO_SIDED||||||Wilcoxon Signed Rank for paired data|||||||0.612
71125342|NCT02100969|141757131|SUPERIORITY||Median Difference (Net)|2.0||||0.047|TWO_SIDED||||||Wilcoxon Signed Rank for paired data||The value of the signed-rank test statistic is 53.|||||0.047
71125343|NCT02100969|141757132|SUPERIORITY||Median Difference (Net)|5.6||||0.901|TWO_SIDED||||||Wilcoxon Signed Rank for paired data|||||||0.901
71125344|NCT02100969|141757133|SUPERIORITY||Median Difference (Net)|4.2||||0.51|TWO_SIDED||||||Wilcoxon Signed Rank for paired data|||||||0.510
71125345|NCT02100969|141757134|SUPERIORITY||Median Difference (Net)|8.3||||0.289|TWO_SIDED||||||Wilcoxon Signed Rank for paired data|||||||0.289
71125346|NCT02100969|141757135|SUPERIORITY||Median Difference (Net)|715.0||||0.0028|TWO_SIDED||||||Wilcoxon Signed Rank for paired data|||||||0.0028
71125347|NCT06359080|141757139|EQUIVALENCE|The difference between post treatment CARS scores and pre treatment CARS scores will be statistically significant as measured by independent sample t-test with p\<.05|Mean Difference (Net)|6.77|STANDARD_DEVIATION|5.5|<|0.05|TWO_SIDED|95.0|5.36|8.19||It's a calculated p-value.|t-test, 2 sided|||||8.19|5.36|<0.05
71125348|NCT01023672|141757163|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon (Mann-Whitney)|||The analysis was done per protocol (n=17)||||0.003
71125349|NCT00448747|141757165|OTHER||ROC AUC|0.923|||||ONE_SIDED|99.0|0.85|||||||Summary of ROC Analyses following macimorelin administration.|||0.850|
71125350|NCT00448747|141757165|OTHER|Sensitivity|sensitivity (percent)|82.0|||||TWO_SIDED|||||||||ROC analysis on peak GH concentrations in response to macimorelin: GH cut point of 2.7 ng/mL.||||
71125351|NCT00448747|141757165|OTHER|Specificity|Specificity (percent)|92.0|||||TWO_SIDED|||||||||ROC analysis on peak GH concentrations in response to macimorelin: GH cut point of 2.7 ng/mL.||||
71087671|NCT00359203|141681545|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.43||||0.04|TWO_SIDED|95.0|0.19|0.96|||Log Rank|The risk of syncope recurrence was based on HR obtained by means of the univarate Cox model, with the use of the Breslow method for ties.|numerator=pacemaker ON denominator=pacemaker OFF|The analysis was designed to have 80% power to detect a 1-year absolute reduction of 25% in the risk of recurrence of first syncope in the Pm ON arm applying a log-rank test with a 2-sided significance level of 0.05. This analysis was planned as a comparison of the cumulative risk of syncope between the 2 groups with the use of a log-rank test.||0.96|0.19|0.04
71087672|NCT00359203|141681545|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The analysis was designed to have 80% power to detect a 1-year absolute reduction of 25% in the risk of recurrence of first syncope in the treatment arm applying a log-rank test with a 2-sided significance level of 0.05.|Hazard Ratio (HR)|0.43||||0.039|TWO_SIDED|95.0|0.19|0.96||For the final analysis the threshold of statistical significance was set at 0.04.|Log Rank||Numerator=pacemaker ON denominator=pacemaker OFF|||0.96|0.19|0.039
71087673|NCT01764841|141681572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7331||||0.065|TWO_SIDED|97.5|0.5027|1.069|||Wald-type test|||The hazard ratio for time to first exacerbation event within 48 weeks and 97.5% Confidence Interval (CI) was calculated by using Cox proportional hazards model by comparison of Cipro 28/Pooled Placebo reporting groups. P-value was analysed using Wald-type test.||1.0690|0.5027|0.0650
71087674|NCT01764841|141681572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5333||||0.0005|TWO_SIDED|97.5|0.3568|0.7971|||Wald-type test|||The hazard ratio for time to first exacerbation event within 48 weeks and 97.5% CI was calculated by using Cox proportional hazards model by comparison of Cipro 14/Pooled Placebo reporting groups. P-value was analysed using Wald-type test.||0.7971|0.3568|0.0005
71087675|NCT01764841|141681573|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.8615||||0.2944|TWO_SIDED|97.5|0.6264|1.1848|||Poisson regression|||A Poisson regression with adjustment for over-/under dispersion was used to analyze the number of exacerbation events over 48 weeks and to test the difference in the frequency of exacerbation between Ciprofloxacin DPI 28 and Pooled placebo group. P-value was analyzed using Wald-type test along with the incidence rate ratio of the comparison.||1.1848|0.6264|0.2944
71087676|NCT01764841|141681573|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.7329||||0.0382|TWO_SIDED|97.5|0.5237|1.0256|||Poisson regression|||A Poisson regression with adjustment for over-/under dispersion was used to analyze the number of exacerbation events over 48 weeks and to test the difference in the frequency of exacerbation between Ciprofloxacin DPI 14 and Pooled placebo group. P-value was analyzed using Wald-type test along with the incidence rate ratio of the comparison.||1.0256|0.5237|0.0382
71087677|NCT01791985|141681585|OTHER||Mean|0.08|STANDARD_DEVIATION|0.32|||TWO_SIDED|||||||||Proportion of change in tumour size at 12 weeks (or progression if prior to week 12), when used in combination with either anastrozole or letrozole in ER positive breast cancer patients who have progressed on treatment with either anastrozole or letrozole in any setting||||
71087678|NCT01103323|141681590|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.774||||0.005178||95.0|0.636|0.942||According to protocol specified O'Brien-Fleming type alpha spending function and 432 death events at 2nd IA, the pre-specified alpha (false positive rate) for this analysis was 0.009279 (1-sided).|Log Rank||Two treatment groups compared using a stratified log-rank test, stratified by same stratification factors as randomization. Hazard ratio (Regorafenib / Placebo) and its 95% confidence interval calculated using Cox model, stratified by same factors.|Sample size based on primary efficacy endpoint of OS. The study was designed to have 90% power to detect 33.3% increase in median OS (i.e. hazard ratio of 0.75, Regorafenib / Placebo). Assuming 1-sided overall alpha of 0.025, randomization ratio of 2:1 for Regorafenib and Placebo, and 2 formal interim analyses of OS using an O'Brien-Fleming-type error spending function, a total of 582 death events were required for primary completion. Results based on 2nd planned formal IA with 432 total events.||0.942|0.636|0.005178
71087679|NCT01103323|141681591|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.494|||<|1e-06||95.0|0.419|0.582||Comparison based on pre-specified alpha level of 0.025 (1-sided).|Log Rank||Hazard ratio (Regorafenib / Placebo)|Two treatment groups compared using a stratified log-rank test, stratified by same stratification factors as randomization. Hazard ratio (Regorafenib / Placebo) and its 95% confidence interval calculated using Cox model, stratified by same factors.||0.582|0.419|<0.000001
71087680|NCT01103323|141681592|SUPERIORITY_OR_OTHER||Difference|-0.6||||0.188432||95.0|-1.74|0.53||Comparison based on pre-specified alpha level of 0.025 (1-sided).|Cochran-Mantel-Haenszel||Difference = Placebo - Regorafenib 160 mg|Two treatment groups compared using Cochran-Mantel-Haenszel (CMH) test adjusting for same stratification factors as at randomization.||0.53|-1.74|0.188432
71087681|NCT01103323|141681593|SUPERIORITY_OR_OTHER||Difference|-25.94|||<|1e-06||95.0|-32.06|-19.82||Comparison based on pre-specified alpha level of 0.025 (1-sided).|Cochran-Mantel-Haenszel||Difference = Placebo - Regorafenib 160 mg|Two treatment groups compared using Cochran-Mantel-Haenszel (CMH) test adjusting for same stratification factors as at randomization.||-19.82|-32.06|<0.000001
71087682|NCT02314728|141681612|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
71087683|NCT02314728|141681613|SUPERIORITY|||||||0.6|||||||Fisher Exact|||NICU admission||||0.60
71087684|NCT02314728|141681613|SUPERIORITY|||||||0.13|||||||Fisher Exact|||histologic chorioamnionitis||||0.13
71087685|NCT03118934|141681627|NON_INFERIORITY|The pre-specified non-inferiority margin is 0.5. With a sample size of 80/group, there was approximately 83% power to reject the null hypothesis of inferiority in fit with assumed standard deviation of 0.6 and expected difference of 0.25 (one-sided alpha=0.05).|LSM Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.06|||ONE_SIDED|95.0||-0.1||||||||-0.1||
71087686|NCT01419314|141681688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|45.19|STANDARD_DEVIATION|20.25||0.001|TWO_SIDED|95.0|38.33|52.05|||ANOVA|Sphericity was not tenable for the factor pain scores, degrees of freedom were corrected using Huynh-Feldt estimates, df (1.71,56.46).||A repeated measure ANOVA was performed to evaluate the contrasts of interest.||52.05|38.33|0.001
71087687|NCT01419314|141681688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.09|STANDARD_ERROR_OF_MEAN|3.6|<|0.0005|TWO_SIDED|95.0|8.8|23.39||Bonferroni adjustment for significance\<0.013.|t-test, 2 sided||Paired t-test contrasting pain scores from baseline to week six of the trial-Splint group. The statistical power for the within splint intervention contrast was calculated to be 0.99.|Null hypothesis: Is there a difference in baseline pain scores compared to those at week 6 in the splinting group?||23.39|8.80|<0.0005
71125352|NCT00448747|141757165|OTHER|Misclassification|misclassification (percent)|13.0|||||TWO_SIDED|||||||||ROC analysis on peak GH concentrations in response to macimorelin: GH cut point of 2.7 ng/mL.||||
70857157|NCT02446743|141200513|OTHER|Vaccine Comparison Day 31 Group 3B vs Day 61 Group B\_0\_1(1 month after booster or 2nd dose)|Ratio of GMTs|1.9|||||TWO_SIDED|95.0|1.52|2.36|||ANOVA|||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||2.36|1.52|
70857158|NCT02446743|141200513|OTHER|Vaccine Comparison Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|Ratio of GMTs|1.88|||||TWO_SIDED|95.0|1.37|2.59|||ANOVA|||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||2.59|1.37|
70857159|NCT02446743|141200513|OTHER|Vaccine Comparison Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|Ratio of GMTs|1.91|||||TWO_SIDED|95.0|1.41|2.58|||ANOVA|||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||2.58|1.41|
70857160|NCT02446743|141200515|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|-2.0|||||TWO_SIDED|95.0|-7.5|1.8|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||1.8|-7.5|
70945804|NCT02367105|141392621|SUPERIORITY||Median Difference (Final Values)|0.01||||0.65|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.65
70945805|NCT02367105|141392622|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.27|TWO_SIDED|||||Baseline value adjusted|Mixed Models Analysis|||||||0.27
70945806|NCT02367105|141392623|SUPERIORITY||Mean Difference (Final Values)|-3.6||||0.39|TWO_SIDED|||||Baseline value adjusted|Mixed Models Analysis|||||||0.39
70945807|NCT02367105|141392624|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.58|TWO_SIDED||||||Mixed Models Analysis|||||||0.58
70857161|NCT02446743|141200515|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|53.0|||||TWO_SIDED|95.0|42.1|62.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||62.5|42.1|
70857162|NCT02446743|141200515|OTHER|1 Month Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|58.0|||||TWO_SIDED|95.0|50.5|64.7|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||64.7|50.5|
70945808|NCT02367105|141392625|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.9|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.90
70945809|NCT02367105|141392626|SUPERIORITY||Mean Difference (Final Values)|-252.0|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||<0.001
71125353|NCT00448747|141757166|OTHER||Mean Difference (Final Values)|-5.1|STANDARD_DEVIATION|9.57|||TWO_SIDED|||||||||Summary of IGF-1 before and after AEZS-130 administration: post - pre differences||||
71125354|NCT00448747|141757166|OTHER||Mean Difference (Final Values)|-2.3|STANDARD_DEVIATION|16.25|||TWO_SIDED|||||||||||||
71125355|NCT02429791|141757193|NON_INFERIORITY|Non-inferiority was concluded if the lower bound of a two-sided 95% confidence interval for the difference in response rates between the two treatment arms was greater than -10%.|Risk Difference (RD)|-0.6|||||TWO_SIDED|95.0|-4.3|3.0|||||Estimates based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factors: Age group (\< or \>=50 years old) and Baseline third agent (PI, NNRTI, INI).|||3.0|-4.3|
71125356|NCT02429791|141757195|OTHER||Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-1.9|4.0|||||Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factors: Age group (\< or \>=50 years old) and Baseline third agent (PI, NNRTI, INI). No formal non-inferiority margin has been pre-specified for secondary endpoints.|||4.0|-1.9|
71125357|NCT02429791|141757206|OTHER|||||||0.007||||||P-value for interaction between treatment group and baseline third agent (25 hydroxy-vitamin D)|ANCOVA|||||||0.007
71125358|NCT02429791|141757206|SUPERIORITY||Odds Ratio (OR)|0.958||||0.275|TWO_SIDED|95.0|0.888|1.034||P value to assess difference between treatment groups (25 hydroxy-vitamin D - NNRTI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and baseline biomarker level.|||1.034|0.888|0.275
71125359|NCT02429791|141757206|SUPERIORITY||Odds Ratio (OR)|0.902||||0.112|TWO_SIDED|95.0|0.793|1.025||P value to assess difference between treatment groups (25 hydroxy-vitamin D - INI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and baseline biomarker level.|||1.025|0.793|0.112
71125360|NCT02429791|141757206|SUPERIORITY||Odds Ratio (OR)|0.847||||0.002|TWO_SIDED|95.0|0.763|0.942||P value to assess difference between treatment groups (25 hydroxy-vitamin D - PI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and baseline biomarker level.|||0.942|0.763|0.002
71125361|NCT02429791|141757208|OTHER|||||||0.001||||||P-value for interaction between treatment group and baseline third agent (bone-specific alkaline phosphatase)|ANCOVA|||||||0.001
71125362|NCT02429791|141757208|SUPERIORITY||Odds Ratio (OR)|0.724|||<|0.001|TWO_SIDED|95.0|0.679|0.772||P value to assess difference between treatment groups (bone-specific alkaline phosphatase - NNRTI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.772|0.679|<.001
71125363|NCT02429791|141757208|SUPERIORITY||Odds Ratio (OR)|0.825|||<|0.001|TWO_SIDED|95.0|0.742|0.918||P value to assess difference between treatment groups (bone-specific alkaline phosphatase - INI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.918|0.742|<.001
71125364|NCT02429791|141757208|SUPERIORITY||Odds Ratio (OR)|0.81|||<|0.001|TWO_SIDED|95.0|0.742|0.884||P value to assess difference between treatment groups (bone-specific alkaline phosphatase - PI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.884|0.742|<.001
71125365|NCT02429791|141757208|OTHER|||||||0.677||||||P-value for interaction between treatment group and Baseline third agent (procollagen type 1-N-propeptide)|ANCOVA|||||||0.677
71125366|NCT02429791|141757208|SUPERIORITY||Odds Ratio (OR)|0.817|||<|0.001|TWO_SIDED|95.0|0.774|0.863||P value to assess difference between treatment groups (procollagen type 1-N-propeptide)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.863|0.774|<.001
71125367|NCT02429791|141757208|OTHER||||||<|0.001||||||P-value for interaction between treatment group and Baseline third agent (osteocalcin)|ANCOVA|||||||<.001
71125368|NCT02429791|141757208|SUPERIORITY||Odds Ratio (OR)|0.881|||<|0.001|TWO_SIDED|95.0|0.823|0.943||P value to assess difference between treatment groups (osteocalcin - NNRTI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.943|0.823|<.001
71125369|NCT02429791|141757208|SUPERIORITY||Odds Ratio (OR)|0.829||||0.001|TWO_SIDED|95.0|0.74|0.93||P value to assess difference between treatment groups (osteocalcin - INI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.930|0.740|0.001
71125370|NCT02429791|141757208|SUPERIORITY||Odds Ratio (OR)|0.691|||<|0.001|TWO_SIDED|95.0|0.628|0.759||P value to assess difference between treatment groups (osteocalcin - PI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.759|0.628|<.001
71125371|NCT02429791|141757208|OTHER|||||||0.782||||||P-value for interaction between treatment group and baseline third agent (type 1 collagen cross-linked C-telopeptide)|ANCOVA|||||||0.782
71125372|NCT02429791|141757208|SUPERIORITY||Odds Ratio (OR)|0.804|||<|0.001|TWO_SIDED|95.0|0.742|0.872||P value to assess difference between treatment groups (type 1 collagen cross-linked C-telopeptide)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.872|0.742|<.001
70945810|NCT02367105|141392627|SUPERIORITY||Mean Difference (Final Values)|-24.9|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Baseline value as covariates||||||<0.001
70857163|NCT02446743|141200515|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|-4.0|||||TWO_SIDED|95.0|-14.1|2.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||2.0|-14.1|
70857164|NCT02446743|141200515|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|44.0|||||TWO_SIDED|95.0|28.1|58.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||58.5|28.1|
70857165|NCT02446743|141200515|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|44.0|||||TWO_SIDED|95.0|32.7|54.1|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||54.1|32.7|
70945811|NCT02367105|141392628|SUPERIORITY||Mean Difference (Final Values)|-2.7|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariates||||||<0.001
71125373|NCT02429791|141757221|OTHER|||||||0.317||||||One-sided p-value from weighted least squares chi-squared statistic. A p-value \<=0.10 was used to indicate statistically significant evidence of heterogeneity in the difference in proportions across levels of each analysis strata.|Chi-squared, Corrected|||||||0.317
71125374|NCT02429791|141757221|OTHER||Risk Difference (RD)|-3.1|||||TWO_SIDED|95.0|-7.7|1.5|||||NNRTI: No formal non-inferiority margin has been pre-specified for secondary endpoints.|||1.5|-7.7|
71125375|NCT02429791|141757221|OTHER||Risk Difference (RD)|2.0|||||TWO_SIDED|95.0|-5.1|9.0|||||INI: No formal non-inferiority margin has been pre-specified for secondary endpoints.|||9.0|-5.1|
71125376|NCT02429791|141757221|OTHER||Risk Difference (RD)|2.8|||||TWO_SIDED|95.0|-5.3|10.8|||||PI: No formal non-inferiority margin has been pre-specified for secondary endpoints.|||10.8|-5.3|
71125377|NCT02429791|141757229|OTHER|||||||0.94||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 4)|ANCOVA|||||||0.940
71125378|NCT02429791|141757229|SUPERIORITY||Mean Difference (Final Values)|-2.924|||<|0.001|TWO_SIDED|95.0|-4.26|-1.588||P value to assess difference between treatment groups (Week 4)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.|||-1.588|-4.260|<.001
71125379|NCT02429791|141757229|OTHER|||||||0.001||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 24)|ANCOVA|||||||0.001
71125380|NCT02429791|141757229|SUPERIORITY||Mean Difference (Final Values)|-1.192||||0.11|TWO_SIDED|95.0|-2.656|0.271||P value to assess difference between treatment groups (Week 24)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.|||0.271|-2.656|0.110
71125381|NCT02429791|141757229|OTHER|||||||0.048||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 48)|ANCOVA|||||||0.048
70945812|NCT02367105|141392629|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.31|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.31
70945813|NCT02367105|141392630|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.42|TWO_SIDED|||||Baseline values as covariates|Mixed Models Analysis|||||||0.42
71125382|NCT02429791|141757229|SUPERIORITY||Mean Difference (Final Values)|-1.569||||0.038|TWO_SIDED|95.0|-3.048|-0.09||P value to assess difference between treatment groups (Week 48)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.|||-0.090|-3.048|0.038
71125383|NCT02429791|141757232|SUPERIORITY|||||||0.002||||||P-value to assess HIVTSQs Total Score difference between treatment groups (Week 4)|Wilcoxon rank sum test|||||||0.002
71125384|NCT02429791|141757232|SUPERIORITY||||||<|0.001||||||P-value to assess HIVTSQs Total Score difference between treatment groups (Week 24)|Wilcoxon rank sum test|||||||<0.001
71125385|NCT02429791|141757232|SUPERIORITY|||||||0.024||||||P-value to assess HIVTSQs Total score difference between treatment groups (Week 48)|Wilcoxon rank sum test|||||||0.024
71125386|NCT02429791|141757232|SUPERIORITY||||||<|0.001||||||P-value to assess HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 4)|Wilcoxon rank sum test|||||||<0.001
71125387|NCT02429791|141757232|SUPERIORITY||||||<|0.001||||||P-value to assess HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 24)|Wilcoxon rank sum test|||||||<0.001
71125388|NCT02429791|141757232|SUPERIORITY|||||||0.005||||||P-value to assess HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 48)|Wilcoxon rank sum test|||||||0.005
71125389|NCT02429791|141757232|SUPERIORITY|||||||0.063||||||P-value to assess HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 4)|Wilcoxon rank sum test|||||||0.063
71125390|NCT02429791|141757232|SUPERIORITY|||||||0.002||||||P-value to assess HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 24)|Wilcoxon rank sum test|||||||0.002
71125391|NCT02429791|141757232|SUPERIORITY|||||||0.099||||||P-value to assess HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 48)|Wilcoxon rank sum test|||||||0.099
71125392|NCT02166463|141757247|SUPERIORITY|||||||0.0001|||||||Log Rank|Used a one-sided log-rank test between 2 arms||Assuming a 3-year EFS of 82% (5-year EFS of 78.4%, long term EFS of 76%) for standard arm, the study will have approximately 86% power for detecting an 8% improvement in 3-year EFS in the Bv-AVEPC arm (3-year EFS of 90%, 5-year EFS of 88.0%, long term EFS of 86.7%) in log rank test.||||0.0001
71125393|NCT03445559|141757300|SUPERIORITY||Odds Ratio (OR)|0.54||||0.006|TWO_SIDED|95.0|0.3|0.98|||Chi-squared|||||0.98|0.30|0.006
71125394|NCT03445559|141757301|SUPERIORITY||Odds Ratio (OR)|1.36||||0.42|TWO_SIDED|95.0|0.7|2.66|||Chi-squared|||||2.66|0.70|0.42
70945814|NCT02367105|141392631|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.69|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.69
71125395|NCT03445559|141757302|SUPERIORITY||Median Difference (Final Values)|2.7|||||TWO_SIDED|||||||||||||
71125396|NCT04676867|141757313|SUPERIORITY|||||||0.2|||||||Log Rank|||||||0.2
71125397|NCT04676867|141757314|SUPERIORITY|||||||0.2|||||||ANCOVA|||||||0.2
71125398|NCT04676867|141757315|SUPERIORITY|||||||0.2|||||||ANCOVA|||||||0.2
71125399|NCT04676867|141757316|SUPERIORITY|||||||0.2|||||||Log Rank|||||||0.2
71125400|NCT04676867|141757317|SUPERIORITY|||||||0.2|||||||Log Rank|||||||0.2
71125401|NCT04676867|141757318|SUPERIORITY|||||||0.2|||||||Log Rank|||||||0.2
71125402|NCT04676867|141757319|SUPERIORITY|||||||0.2|||||||Log Rank|||||||0.2
71125403|NCT04676867|141757320|SUPERIORITY|||||||0.2|||||||ANCOVA|||||||0.2
71125404|NCT04676867|141757321|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
71125405|NCT04676867|141757322|SUPERIORITY|||||||0.2|||||||Regression, Logistic|||||||0.2
71125406|NCT04676867|141757323|SUPERIORITY|||||||0.2|||||||Regression, Logistic|||||||0.2
71125407|NCT04676867|141757325|SUPERIORITY|||||||0.2|||||||ANOVA|||||||0.2
71125408|NCT04676867|141757326|SUPERIORITY|||||||0.2|||||||Regression, Logistic|||||||0.2
71125409|NCT00548717|141757343|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||t-test, 2 sided|||Comparison between Grade 0-I aGVHD vs Grade II-IV aGVHD in the Siro/MMF group at week 1.||||0.77
71125410|NCT00548717|141757343|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||t-test, 2 sided|||Comparison between Grade 0-I aGVHD vs Grade II-IV aGVHD in the Siro/MMF group at week 2.||||0.59
71125411|NCT00548717|141757343|SUPERIORITY_OR_OTHER|||||||0.92|TWO_SIDED||||||t-test, 2 sided|||Comparison between Grade 0-I aGVHD vs Grade II-IV aGVHD in the Siro/MMF group at week 3.||||0.92
71125412|NCT00548717|141757343|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED||||||t-test, 2 sided|||Comparison between Grade 0-I aGVHD vs Grade II-IV aGVHD in the Siro/MMF group at week 8.||||0.63
71125413|NCT00548717|141757343|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||t-test, 2 sided|||Comparison between Grade 0-I aGVHD vs Grade II-IV aGVHD in the Siro/MMF group at week 12.||||0.79
71125414|NCT01302054|141757347|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.37|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-2.63|-2.02||Statistical testing: one-sided, at alpha = 0.025.|t-test, 1 sided|||||-2.02|-2.63|<0.0001
71125415|NCT01302054|141757348|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0079|TWO_SIDED|95.0|-0.87|-0.13||Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used. Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Multiple hypothesis testing was carried out in a hierarchical sequentially rejective manner. Statistical testing between fesoterodine and placebo (Analysis of covariance \[ANCOVA\]) was carried out only if the change from baseline at Week 12 in UUI episodes for fesoterodine group was found statistically significant (paired t-test).||-0.13|-0.87|0.0079
71125416|NCT01302054|141757349|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.0931|TWO_SIDED|95.0|-0.86|0.07||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||0.07|-0.86|0.0931
71125417|NCT01302054|141757350|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.34||0.0438|TWO_SIDED|95.0|-1.37|-0.02||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||-0.02|-1.37|0.0438
71125418|NCT01302054|141757351|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Change at Week 12: the p-value was obtained from a Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country.|Cochran-Mantel-Haenszel|||||||<0.0001
71125419|NCT01302054|141757352|SUPERIORITY_OR_OTHER|||||||0.0095|TWO_SIDED|||||Change at Week 12: the p-value was obtained from a Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country.|Cochran-Mantel-Haenszel|||||||0.0095
71125420|NCT01302054|141757353|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.34|STANDARD_ERROR_OF_MEAN|1.91||0.0001|TWO_SIDED|95.0|-11.1|-3.58||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||-3.58|-11.10|0.0001
71125421|NCT01302054|141757354|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|9.01|STANDARD_ERROR_OF_MEAN|1.98|<|0.0001|TWO_SIDED|95.0|5.12|12.91||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Concern Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||12.91|5.12|<0.0001
71125422|NCT01302054|141757354|SUPERIORITY_OR_OTHER||LS Mean Difference|7.75|STANDARD_ERROR_OF_MEAN|1.97|<|0.0001|TWO_SIDED|95.0|3.87|11.62||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Coping Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||11.62|3.87|<0.0001
71125423|NCT01302054|141757354|SUPERIORITY_OR_OTHER||LS Mean Difference|6.52|STANDARD_ERROR_OF_MEAN|2.0||0.0012|TWO_SIDED|95.0|2.6|10.45||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Sleep Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||10.45|2.60|0.0012
71125424|NCT01302054|141757354|SUPERIORITY_OR_OTHER||LS Mean Difference|4.13|STANDARD_ERROR_OF_MEAN|1.64||0.0123|TWO_SIDED|95.0|0.9|7.36||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Social Interaction Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||7.36|0.90|0.0123
70857166|NCT02446743|141200515|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|vaccine group difference|0.0|||||TWO_SIDED|95.0|-8.0|4.8|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.8|-8.0|
70857167|NCT02446743|141200515|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|Vaccine group difference|60.0|||||TWO_SIDED|95.0|45.0|71.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||71.5|45.0|
70857168|NCT02446743|141200515|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|vaccine group difference|71.0|||||TWO_SIDED|95.0|61.2|78.5|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||78.5|61.2|
70857169|NCT02446743|141200515|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|-1.0|||||TWO_SIDED|95.0|-9.1|4.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||4|-9.1|
70857170|NCT02446743|141200515|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|37.0|||||TWO_SIDED|95.0|27.0|48.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||48.1|27.0|
70857171|NCT02446743|141200515|OTHER|1 Month Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|33.0|||||TWO_SIDED|95.0|25.2|40.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||40.4|25.2|
70857172|NCT02446743|141200515|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|2.0|||||TWO_SIDED|95.0|-8.7|10.2|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||10.2|-8.7|
70857173|NCT02446743|141200515|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|43.0|||||TWO_SIDED|95.0|27.7|58.6|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||58.6|27.7|
70945815|NCT02367105|141392632|SUPERIORITY||Mean Difference (Final Values)|-13.1||||0.23|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.23
70945816|NCT02367105|141392633|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.01
71087688|NCT01419314|141681688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.23|STANDARD_ERROR_OF_MEAN|5.27||0.155|TWO_SIDED|95.0|-13.93|7.47||Bonferroni adjustment for significance\<0.013.|t-test, 2 sided|df(35)|The statistical power for the between intervention contrast was calculated to be 0.26|Null Hypothesis: There is not difference in pain scores between the liner and splint applications at week three.||7.47|-13.93|0.155
71087689|NCT01419314|141681688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.67|STANDARD_ERROR_OF_MEAN|6.66||0.155|TWO_SIDED|95.0|-23.2|3.85|||t-test, 2 sided|df(35)||Null Hypothesis: There is no difference in pain scores between the liner and splint applications at week six.||3.85|-23.20|0.155
71087690|NCT04794751|141681722|NON_INFERIORITY|Non-Inferiority was declared if the upper limit of the 95% confidence interval of the LSM difference between the Test and Control was below 0.05 logMAR.|least-square mean difference|-0.018|STANDARD_ERROR_OF_MEAN|0.0106|||TWO_SIDED|95.0|-0.039|0.002|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test minus Control|Distance (4m)||0.002|-0.039|
71087691|NCT04794751|141681722|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the 95% confidence interval of the LSM difference between the Test and Control was below 0.05 logMAR.|least-square mean difference|-0.007|STANDARD_ERROR_OF_MEAN|0.0127|||TWO_SIDED|95.0|-0.032|0.018|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test minus Control|Intermediate (64cm)||0.018|-0.032|
71087692|NCT04794751|141681722|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the 95% confidence interval of the LSM difference between the Test and Control was below 0.05 logMAR.|least-square mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.0124|||TWO_SIDED|95.0|-0.034|0.015|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test minus Control|Near (40cm)||0.015|-0.034|
71087693|NCT04794751|141681723|NON_INFERIORITY|Non-inferiority was declared if the lower limit of the 95% confidence interval for the least-square mean difference was greater than -5.|least-square mean difference|0.1|STANDARD_ERROR_OF_MEAN|2.34|||TWO_SIDED|95.0|-4.6|4.8|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test minus Control|||4.8|-4.6|
71087694|NCT03044314|141681759|SUPERIORITY|||||||0.148|||||||t-test, 2 sided|||Null hypothesis: inhalation with iNO (the gold standard) would provide greater response than the comparator (iloprost).||||0.148
71125425|NCT01302054|141757354|SUPERIORITY_OR_OTHER||LS Mean Difference|7.1|STANDARD_ERROR_OF_MEAN|1.77|<|0.0001|TWO_SIDED|95.0|3.63|10.57||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Total HRQL - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||10.57|3.63|<0.0001
71125426|NCT01302054|141757355|SUPERIORITY_OR_OTHER|||||||0.0023|TWO_SIDED|||||The p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.|Cochran-Mantel-Haenszel|||||||0.0023
71125427|NCT01302054|141757356|SUPERIORITY_OR_OTHER|||||||0.0027|TWO_SIDED|||||The p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.|Cochran-Mantel-Haenszel|||||||0.0027
71125428|NCT01302054|141757357|SUPERIORITY_OR_OTHER|||||||0.0427|TWO_SIDED|||||Treatment difference at Week 4: p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.|Cochran-Mantel-Haenszel|||||||0.0427
71125429|NCT01302054|141757357|SUPERIORITY_OR_OTHER|||||||0.1461|TWO_SIDED|||||Treatment difference at Week 12: p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.|Cochran-Mantel-Haenszel|||||||0.1461
71125430|NCT02809053|141757361|OTHER|The 95%CI (confidence interval) for the difference in the overall response rate (ORR) was calculated using the Newcombe-Wilson method based on CMH (Cochran-Mantel-Haenszel) weight with stratification factor FLIPI-2 (low, intermediate and high risk).|Adjusted Difference Rate (%)|-4.2|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.0|-14.8|6.35|||||Comparison: SAIT101 versus MabThera.|Adjusted Difference Rate (%) in Overall Response Rate (ORR) of SAIT101 versus MabThera at Week 28.||6.35|-14.80|
71125431|NCT02809053|141757362|OTHER|The 95%CI (confidence interval) for the difference in the overall response rate (ORR) was calculated using the Newcombe-Wilson method based on CMH (Cochran-Mantel-Haenszel) weight with stratification factor FLIPI-2 (low, intermediate and high risk).|Adjusted Difference Rate|-10.3|STANDARD_ERROR_OF_MEAN|5.42|||TWO_SIDED|95.0|-20.92|0.61|||||Comparison: SAIT101 versus MabThera|Adjusted Difference Rate of Overall Response Rate (ORR) of SAIT101 versus MabThera at Week 12.||0.61|-20.92|
71125432|NCT02809053|141757367|OTHER|The estimated Hazard Ratio with 95% CI was obtained from Cox regression model; however, stratification factors, ie, FLIPI-2 (low, intermediate and high risk), were only taken into account if FLIPI-2 score=all.|Hazard Ratio (HR)|1.724|||||TWO_SIDED|95.0|0.853|3.482|||||Hazard Ration of TTE SAIT101:MabThera|Time to Event (TTE) Hazard Ratio (HR) of SAIT101:MabThera. The TTE is defined as the time from the date of randomization to the date when an event occurs; an event is disease progression as assessed by Investigator, death due to any cause, or the start of new treatment, whichever comes first.||3.482|0.853|
71125433|NCT02809053|141757368|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%).|GLS Mean Difference (%)|101.39|||||TWO_SIDED|90.0|95.86|107.24|||||Comparison: SAIT101 versus MabThera. Equivalence was demonstrated for SAIT101 and MabThera with exposure pharmacokinetic parameter AUC0-168,w1 within the standard acceptance limits for bioequivalence (80.00% to 125.00%).|Statistical Comparison: geometric least square (GLS) Mean Ratio (90% Confidence Interval (CI)) (%) of SAIT101 versus MabThera Area Under the Concentration time Curve Day 0 to Week 1 (AUC0-168,w1) (h×µg/mL). The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model with fixed effect for treatment.||107.24|95.86|
71125434|NCT02809053|141757368|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%).|GLS Mean Difference (%)|96.92|||||TWO_SIDED|90.0|90.85|103.4|||||Comparison: SAIT101 versus MabThera. Pharmacokinetic equivalence was demonstrated for SAIT101 and MabThera with exposure PK parameter AUC0-168,w4 within the standard acceptance limits for bioequivalence (80.00% to 125.00%).|Statistical Comparison: geometric least square (GLS) Mean Ratio (90% Confidence Interval (CI)) %) of SAIT101 versus MabThera Area Under the Concentration time Cure Day 0 to Week 4 (AUC0-168,w4) (h×µg/mL). The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model with fixed effect for treatment.||103.40|90.85|
71125435|NCT02809053|141757369|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00|GLS Mean Ratio (%)|99.35|||||TWO_SIDED|90.0|90.85|103.4|||||Comparison: SAIT101 versus MabThera. Pharmacokinetic equivalence was demonstrated for SAIT101 and MabThera with Cmax,w1 exposure within the standard acceptance limits for bioequivalence (80.00% to 125.00%).|Statistical Comparison: geometric least square (GLS) Mean Ratio (90% CI) (%) of SAIT101 versus MabThera maximum plasma concentration at Week 1 (Cmax,w1) (h×µg/mL). The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model with fixed effect for treatment.||103.40|90.85|
70857174|NCT02446743|141200515|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|42.0|||||TWO_SIDED|95.0|31.1|53.0|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||53.0|31.1|
70857175|NCT02446743|141200515|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|vaccine group difference|-6.0|||||TWO_SIDED|95.0|-19.2|0.9|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||0.9|-19.2|
70945817|NCT02367105|141392634|SUPERIORITY||Mean Difference (Net)|-1.0||||0.36|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariates||||||0.36
70945818|NCT02367105|141392635|SUPERIORITY||Mean Difference (Final Values)|-8.6||||0.23|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariates||||||0.23
70945819|NCT02367105|141392636|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.69|TWO_SIDED||||||Mixed Models Analysis|Baseline values adjusted||||||0.69
70945820|NCT02367105|141392637|SUPERIORITY||Number of participants|0.0|||>|0.05|TWO_SIDED|||||A priori threshold = voxel p\<.001, cluster p\<.05, false discovery rate (FDR) whole brain correction. There is no correction for multiple seeds given small sample sizes and pre-post design.|t-test, 2 sided|||||||>.05
70945821|NCT02367105|141392638|SUPERIORITY||Mean Difference (Net)|0.23|STANDARD_ERROR_OF_MEAN|0.05||0.37|TWO_SIDED|||||Using DESeq2 R package. P values were adjusted using the Benjamini and Hochberg's approach for controlling the false discovery rate.|t-test, 2 sided|||6 months vs Baseline||||0.37
70945822|NCT02367105|141392638|SUPERIORITY||Mean Difference (Net)|0.58|STANDARD_ERROR_OF_MEAN|0.12||0.02|TWO_SIDED|||||Using DESeq2 R package. P values were adjusted using the Benjamini and Hochberg's approach for controlling the false discovery rate|t-test, 2 sided|||6 months vs Baseline||||.02
70945823|NCT02367105|141392639|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|1.3||0.05|TWO_SIDED||||||Mixed Models Analysis|Final vs baseline||||||.05
70945824|NCT02367105|141392639|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|1.3||0.3|TWO_SIDED||||||Mixed Models Analysis|Final vs baseline||||||0.3
71125436|NCT02809053|141757369|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%).|GLS Mean Ration (%)|99.23|||||TWO_SIDED|90.0|92.96|105.92|||||Comparison: SAIT101 versus MabThera. Pharmacokinetic equivalence was demonstrated for SAIT101 and MabThera with exposure PK parameter Cmax,w4 within the standard acceptance limits for bioequivalence (80.00% to 125.00%).|Statistical Comparison: geometric least square (GLS) Mean Ratio (90% CI) (%) of SAIT101 versus MabThera maximum plasma concentration at Week 4 (Cmax,w1) (h×µg/mL). The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model with fixed effect for treatment||105.92|92.96|
70857176|NCT02446743|141200515|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|vaccine group difference|32.0|||||TWO_SIDED|95.0|18.2|47.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||47.0|18.2|
70857177|NCT02446743|141200515|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|vaccine group difference|24.0|||||TWO_SIDED|95.0|13.2|34.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||34.4|13.2|
70945825|NCT03231969|141392640|SUPERIORITY||Mean Difference (Final Values)|-0.791||||0.0002|TWO_SIDED|95.0|-1.203|-0.378|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.2% arm minus Bilastine 0% (Vehicle) arm at Visit 4b (including all time points).||-0.378|-1.203|0.0002
70945826|NCT03231969|141392640|SUPERIORITY||Mean Difference (Final Values)|-0.851|||<|0.0001|TWO_SIDED|95.0|-1.263|-0.439|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.4% arm minus Bilastine 0% (Vehicle) arm at Visit 4b (including all time points).||-0.439|-1.263|<.0001
70945827|NCT03231969|141392640|SUPERIORITY||Mean Difference (Final Values)|-1.545|||<|0.0001|TWO_SIDED|95.0|-1.954|-1.135|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.6% arm minus Bilastine 0% (Vehicle) arm at Visit 4b (including all time points).||-1.135|-1.954|<.0001
70945828|NCT03231969|141392640|SUPERIORITY||Mean Difference (Final Values)|-1.208|||<|0.0001|TWO_SIDED|95.0|-1.639|-0.778|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.2% arm minus Bilastine 0% (Vehicle) arm at Visit 5b (including all time points).||-0.778|-1.639|<.0001
70945829|NCT03231969|141392640|SUPERIORITY||Mean Difference (Final Values)|-1.245|||<|0.0001|TWO_SIDED|95.0|-1.679|-0.811|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.4% arm minus Bilastine 0% (Vehicle) arm at Visit 5b (including all time points).||-0.811|-1.679|<.0001
70945830|NCT03231969|141392640|SUPERIORITY||Mean Difference (Final Values)|-1.846|||<|0.0001|TWO_SIDED|95.0|-2.273|-1.418|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.6% arm minus Bilastine 0% (Vehicle) arm at Visit 5b (including all time points).||-1.418|-2.273|<.0001
70945831|NCT03231969|141392640|SUPERIORITY||Mean Difference (Final Values)|-1.696|||<|0.0001|TWO_SIDED|95.0|-2.08|-1.312|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.2% arm minus Bilastine 0% (Vehicle) arm at Visit 6 (including all time points).||-1.312|-2.080|<.0001
70945832|NCT03231969|141392640|SUPERIORITY||Mean Difference (Final Values)|-1.617|||<|0.0001|TWO_SIDED|95.0|-2.001|-1.232|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.4% arm minus Bilastine 0% (Vehicle) arm at Visit 6 (including all time points).||-1.232|-2.001|<.0001
70945833|NCT03231969|141392640|SUPERIORITY||Mean Difference (Final Values)|-2.009|||<|0.0001|TWO_SIDED|95.0|-2.387|-1.63|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.6% arm minus Bilastine 0% (Vehicle) arm at Visit 6 (including all time points).||-1.630|-2.387|<.0001
70945834|NCT00129649|141392641|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
70857178|NCT02446743|141200515|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|0.0|||||TWO_SIDED|95.0|-4.7|3.4|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||3.4|-4.7|
70857179|NCT02446743|141200515|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|36.0|||||TWO_SIDED|95.0|25.6|45.7|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||45.7|25.6|
70857180|NCT02446743|141200515|OTHER|1 Month Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|54.0|||||TWO_SIDED|95.0|45.2|61.1|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||61.1|45.2|
70857181|NCT02446743|141200515|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|0.0|||||TWO_SIDED|95.0|-8.4|5.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.0|-8.4|
70857182|NCT02446743|141200515|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|29.0|||||TWO_SIDED|95.0|12.1|43.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||43.0|12.1|
70857183|NCT02446743|141200515|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|Vaccine group difference|46.0|||||TWO_SIDED|95.0|33.6|57.1|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/154 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||57.1|33.6|
70857184|NCT02446743|141200515|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-8.0|5.4|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.4|-8.0|
70857185|NCT02446743|141200515|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|Vaccine group difference|42.0|||||TWO_SIDED|95.0|27.8|54.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||54.5|27.8|
70857186|NCT02446743|141200515|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|vaccine group difference|60.0|||||TWO_SIDED|95.0|47.9|69.6|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||69.6|47.9|
70857187|NCT02446743|141200515|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|3.0|||||TWO_SIDED|95.0|-1.1|5.4|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.4|-1.1|
70857188|NCT02446743|141200515|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|28.0|||||TWO_SIDED|95.0|19.1|34.9|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||34.9|19.1|
70945835|NCT01163955|141392659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8|STANDARD_DEVIATION|1.92|<|0.0005|TWO_SIDED|95.0|0.0|9.0|||t-test, 2 sided|DF=50||Start total score at 0 minutes is being compared to the end total score at 5 minutes while sitting in the floor.||9|0|<.0005
70945836|NCT01163955|141392659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|STANDARD_DEVIATION|1.99|<|0.0005|TWO_SIDED|95.0|0.0|9.0|||t-test, 2 sided|DF=50||Start total score at 0 minutes is being compared to the end total score at 5 minutes while sitting in a chair.||9|0|<.0005
70945837|NCT02586415|141392661|SUPERIORITY||Odds Ratio (OR)|2.77|||<|0.001|TWO_SIDED|95.0|1.63|4.7||Criteria to assess superiority was a two-sided P value of \<0.05. The study was terminated early because the pre-specified stopping boundary of P \<0.0025 was crossed at the first interim analysis (N=182)|Cochran-Mantel-Haenszel|||||4.70|1.63|<0.001
70945838|NCT01313624|141392713|SUPERIORITY_OR_OTHER||Difference in least squares mean|0.8||||0.68|TWO_SIDED|95.0|-3.1|4.7||P-value was based on T-test from mixed-effect model repeated measures (MMRM).|MMRM|||||4.7|-3.1|0.68
70945839|NCT01313624|141392714|SUPERIORITY_OR_OTHER||Difference in least squares mean|1.3||||0.56|TWO_SIDED|95.0|-3.0|5.6||P-value was based on T-test from mixed-effect model repeated measures (MMRM).|MMRM|||||5.6|-3.0|0.56
70945840|NCT03121612|141392749|SUPERIORITY|Power calculated based on 40 infants in each arm, permitting detection of a difference of 0.67 SD between the groups with power of 80% and alpha=0.05. Study recruitment was below anticipated (51/80) despite extending the planned period of recruitment.||||||0.65||||||Threshold for superiority p\<0.05; primary outcome, so not adjusted for multiple comparisons.|van Elteren's extension to Wilcoxon|van Elteren's extension used to control for stratification by gestation||"Analysis restricted to change at 6 hours, as least affected by missing data.~Distribution non-normal, so non-parametric test (Wilcoxon) used."||||0.65
70945841|NCT03121612|141392749|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Planned sub-group analysis for infants born at 28-33 gestational weeks (n=41). No adjustment for multiple comparisons.||||0.64
70857189|NCT02446743|141200515|OTHER|1 Month Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|39.0|||||TWO_SIDED|95.0|31.6|46.6|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||46.6|31.6|
70857190|NCT02446743|141200515|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|Vaccine group difference|2.0|||||TWO_SIDED|95.0|-4.9|6.7|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||6.7|-4.9|
70945842|NCT03121612|141392749|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Planned sub-group analysis for infants born at 34-36 gestational weeks (n=10). No adjustment for multiple comparisons.||||1.0
70945843|NCT03121612|141392750|SUPERIORITY|Power calculated based on 40 infants in each arm, permitting detection of a difference of 0.67 SD between the groups with power of 80% and alpha=0.05. Study recruitment was below anticipated (51/80) despite extending the planned period of recruitment.||||||0.8||||||Threshold for superiority p\<0.05; not adjusted for multiple comparisons|van Elteren's extension to Wilcoxon|van Elteren's extension used to control for stratification by gestation.||"Analysis restricted to change at 6 hours, as least affected by missing data.~Distribution not normal by visual examination, so non-parametric test (Wilcoxon) used."||||0.80
70945844|NCT03121612|141392751|SUPERIORITY|Power calculated based on 40 infants in each arm, permitting detection of a difference of 0.67 SD between the groups with power of 80% and alpha=0.05. Study recruitment was below anticipated (51/80) despite extending the planned period of recruitment.||||||0.86||||||Threshold for superiority p\<0.05; not adjusted for multiple comparisons.|van Elteren's extension to Wilcoxon|van Elteren's extension used to control for stratification by gestation.||"Analysis restricted to change at 6 hours, as least affected by missing data.~Distribution non-normal, so non-parametric test (Wilcoxon) used."||||0.86
70945845|NCT03121612|141392755|SUPERIORITY|||||||1||||||Not adjusted for multiple comparisons.|Fisher Exact|No failures in older stratum, so stratification by gestational age-group not controlled for in analysis.||||||1.0
71125437|NCT02809053|141757372|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%).|GLS Mean Ratio (%)|95.45|||||TWO_SIDED|90.0|88.85|102.55|||||Comparison: SAIT101 versus MabThera. Pharmacokinetic equivalence was demonstrated for SAIT101 and MabThera with exposure PK parameter Ctrough,d29 within the standard acceptance limits for bioequivalence (80.00% to 125.00%).|Statistical Comparison: geometric least square (GLS) Mean Ratio (90% CI) (%) of SAIT101 versus MabThera trough plasma concentration at the end of the dosing period (Day 29) (Ctrough,d29) (µg/mL) . The statistical comparison of the log-transformed primary parameters between treatments is based on an analysis of variance model with fixed effect for treatment||102.55|88.85|
71125438|NCT02809053|141757376|OTHER||Mean Difference (Final Values)|7.2|||||TWO_SIDED|90.0|-31.0|45.4|||||Comparison: SAIT101 versus MabThera|Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 1 (AUEC0-168,w1), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||45.4|-31.0|
71125439|NCT02809053|141757376|OTHER||Mean Difference (Final Values)|18.0|||||TWO_SIDED|90.0|-21.6|57.6|||||Comparison: SAIT101 versus MabThera.|Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 2 (AUEC0-168,w2), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||57.6|-21.6|
71125440|NCT02809053|141757376|OTHER||Mean Difference (Final Values)|21.4|||||TWO_SIDED|90.0|-18.3|61.0|||||Comparison: SAIT101 versus MabThera.|Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 3 (AUEC0-168,w3), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||61.0|-18.3|
71125441|NCT02809053|141757376|OTHER||Mean Difference (Final Values)|20.4|||||TWO_SIDED|90.0|-19.3|60.2|||||comparison: SAIT101 versus MabThera|Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 4 (AUEC0-168,w4), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||60.2|-19.3|
71125442|NCT02809053|141757376|OTHER||Mean Difference (Final Values)|15.7|||||TWO_SIDED|90.0|-23.1|54.6|||||Comparison: SAIT101 versus MabThera|Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 12 (AUEC0-168,w12), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||54.6|-23.1|
71125443|NCT02809053|141757376|OTHER||Mean Difference (Final Values)|12.8|||||TWO_SIDED|90.0|-26.0|51.8|||||Comparison: SAIT101 versus MabThera.|Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 28 (AUEC0-168,w28), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||51.8|-26.0|
71125444|NCT02809053|141757380|OTHER|||||||0.587||||||The p-value was calculated using Gail-Simon Test for Qualitative Interactions.|Gail-Simon|||Exploratory statistical analysis: Comparison of Overall Response Rate (ORR) by Region (European Union / Other). The interaction p-value for the Region subgroup was calculated based upon the full set of data, and based on a Cochran Mantel Haenszel (CMH) model including treatment, and applicable stratification covariate.||||0.587
70945846|NCT03121612|141392756|SUPERIORITY|||||||0.33||||||Not adjusted for multiple comparisons|Cochran-Mantel-Haenszel|Controlling for stratification by gestational group.||||||0.33
71125445|NCT02809053|141757380|OTHER|||||||0.421||||||The p-value was calculated using Gail-Simon Test for Qualitative Interactions.|Gail-Simon|||Exploratory statistical analysis. Overall Response Rate by Age Group (18-60 years and \>60 years). The interaction p-value for the Age subgroup was calculated based upon the full set of data, and based on a Cochran Mantel Haenszel (CMH) model including treatment, and applicable stratification covariate.||||0.421
71125446|NCT02809053|141757380|OTHER|||||||0.288||||||The p-value was calculated using Gail-Simon Test for Qualitative Interactions.|Gail-Simon|||Exploratory statistical analysis. Comparison of Overall Response Rate (ORR) by Gender (Male / Female). The interaction p-value for the Gender subgroup was calculated based upon the full set of data, and based on a Cochran Mantel Haenszel (CMH) model including treatment, and applicable stratification covariate. The p-value was calculated using Gail-Simon Test for Qualitative Interactions.||||0.288
71125447|NCT02809053|141757380|OTHER|||||||0.588||||||The p-value was calculated using Gail-Simon Test for Qualitative Interactions.|Gail-Wilson|||Exploratory statistical analysis. Comparison of Overall Response Rate (ORR) by Anti-drug Antibody (ADA) status (Positive / Negative). The interaction p-value for the ADA subgroup was calculated based upon the full set of data, and based on a Cochran Mantel Haenszel (CMH) model including treatment, and applicable stratification covariate.||||0.588
71125448|NCT01571453|141757450|NON_INFERIORITY_OR_EQUIVALENCE|Vortioxetine was declared to be non-inferior to venlafaxine if the upper limit of the calculated two-sided 95% confidence interval for the treatment difference at Week 8 between vortioxetine and venlafaxine was less than +2.5 MADRS units versus venlafaxine.|Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.93||0.199||95.0|-3.03|0.63||No adjustments for multiple comparisons were made.|ANCOVA|LOCF was used.||The sample size calculation was based on a non-inferiority comparison of the treatment groups in the change from baseline to Week 8 in MADRS total score using a two-sided 95% CI against a margin of +2.5 points. Assuming a standard deviation of 9.0 points and an expected true mean difference between treatments of 0 points, a total of 410 patients (205 per treatment group) were needed to provide a power of 80% for correctly concluding non-inferiority.||0.63|-3.03|0.199
71125449|NCT01571453|141757451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.12||0.228|TWO_SIDED|95.0|-0.39|0.09||No adjustments for multiple comparisons were made.|ANCOVA|LOCF was used.||The same ANCOVA methodology as for the primary endpoint was used.||0.09|-0.39|0.228
70945847|NCT03121612|141392757|SUPERIORITY|||||||0.31||||||Not adjusted for multiple comparisons|Cochran-Mantel-Haenszel|Controlling for stratification by gestational age-group.||||||0.31
70945848|NCT03121612|141392758|SUPERIORITY|||||||0.81||||||Not adjusted for multiple comparisons.|van Elteren's extension to Wilcoxon|van Elteren's extension used to control for stratification by gestation||||||0.81
70945849|NCT03121612|141392759|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
70945850|NCT03121612|141392765|SUPERIORITY|||||||1||||||No adjustment for multiple comparisons.|Fisher Exact|No failures in older stratum, so stratification by gestational age-group not controlled for in analysis.||||||1.0
70945851|NCT03121612|141392767|SUPERIORITY|||||||1|||||||Fisher Exact|No adjustment for multiple comparisons||||||1.0
70945852|NCT01841112|141392774|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.3712|||||TWO_SIDED|95.0|0.7272|2.0151|||||The standard error of slope estimate = 0.3038.|Dose proportionality was assessed in Chinese subjects. For the power model perfect dose proportionality would correspond to a slope of 1.||2.0151|0.7272|
70945853|NCT01841112|141392774|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.3652|||||TWO_SIDED|95.0|1.0421|1.6883|||||The standard error of slope estimate = 0.1516.|Dose proportionality was assessed in Japanese subjects. For the power model perfect dose proportionality would correspond to a slope of 1.||1.6883|1.0421|
71087695|NCT03044314|141681761|SUPERIORITY|||||||0.346|||||||Fisher Exact|||Null hypothesis was that fewer patients receiving iloprost (new agent) would respond compared to iNO (the gold standard).||||0.346
71087696|NCT02563899|141681794|SUPERIORITY_OR_OTHER||Percent difference in treatment|-1.0|||||TWO_SIDED|95.0|-42.2|39.9||||||Umeclidinium, 2 mg/cm\^2 of 1.85%, OD Vs Vehicle: \<=-30%||39.9|-42.2|
71087697|NCT02563899|141681794|SUPERIORITY_OR_OTHER||Percent difference in treatment|1.0|||||TWO_SIDED|95.0|-39.9|42.2||||||Umeclidinium, 2 mg/cm\^2 of 1.85%, OD vs Vehicle: \<=-50%||42.2|-39.9|
71087698|NCT02563899|141681794|SUPERIORITY_OR_OTHER||Percent difference in treatment|9.0|||||TWO_SIDED|95.0|-25.2|44.0||||||Umeclidinium, 2 mg/cm\^2 of 1.85%, OD Vs Vehicle: \<=-70%||44.0|-25.2|
70945854|NCT01841112|141392775|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.1998|||||TWO_SIDED|95.0|0.4794|1.9202|||||The standard error of slope estimate = 0.3380.|Dose proportionality was assessed in Chinese subjects. For the power model perfect dose proportionality would correspond to a slope of 1.||1.9202|0.4794|
70945855|NCT01841112|141392775|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.0299|||||TWO_SIDED|95.0|0.7131|1.3466|||||The standard error of slope estimate = 0.1486.|Dose proportionality was assessed in Japanese subjects. For the power model perfect dose proportionality would correspond to a slope of 1.||1.3466|0.7131|
70945856|NCT01841112|141392776|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.2015|||||TWO_SIDED|95.0|0.5078|1.8952|||||The standard error of slope estimate = 0.3272.|Dose proportionality was assessed in Chinese subjects. For the power model perfect dose proportionality would correspond to a slope of 1.||1.8952|0.5078|
70945857|NCT01841112|141392776|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.0301|||||TWO_SIDED|95.0|0.7133|1.3469|||||The standard error of slope estimate = 0.1486.|Dose proportionality was assessed in Japanese subjects. For the power model perfect dose proportionality would correspond to a slope of 1.||1.3469|0.7133|
70945858|NCT00878553|141392783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.606|STANDARD_ERROR_OF_MEAN|2.42||0.0118|TWO_SIDED|95.0|-15.284|-1.927||Change from baseline in mean WASO3-7 compared values for the 20-mg dose vs. placebo. If that comparison demonstrated superiority of the 20-mg dose, then results for the 15-mg dose vs. placebo were compared; if significant, then 10-mg vs. placebo|Mixed Models Analysis|This hierarchical, 2-sided testing procedure maintained the overall level of significance at approximately 0.05|Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment. A negative mean change from baseline indicates an improvement.|Literature-based estimates of WASO (Wake After Sleep Onset) SD (Standard Deviation) range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 15-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes||-1.927|-15.284|0.0118
70945859|NCT00878553|141392783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.98|STANDARD_ERROR_OF_MEAN|2.421||0.0037|TWO_SIDED|95.0|-16.685|-3.275||Change from baseline in mean WASO3-7 compared values for the 20-mg dose vs. placebo. If that comparison demonstrated superiority of the 20-mg dose, then results for the 15-mg dose vs. placebo were compared; if significant, then 10-mg vs. placebo|Mixed Models Analysis|This hierarchical, 2-sided testing procedure maintained the overall level of significance at approximately 0.05|Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment. A negative mean change from baseline indicates an improvement|Literature-based estimates of WASO SD range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 15-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes||-3.275|-16.685|0.0037
71087699|NCT02563899|141681796|SUPERIORITY_OR_OTHER||Percent difference in treatment|27.0|||||TWO_SIDED|95.0|-8.5|62.6||||||||62.6|-8.5|
71087700|NCT00794664|141681828|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p≤0.05|t-test, 2 sided|||Based upon prior clinical study experience with mipomersen, it was estimated that the standard deviation of the percent change in LDL-C was approximately 22%. With 15 patients in the control group and 30 patients in the mipomersen-treated group, this study would have at least 80% power to detect a 20 percentage point difference between the 2 treatment groups. Enrollment was to be conducted such that at least 51 patients were randomized to allow for potential exclusions from an analysis set.||||<0.001
70857191|NCT02446743|141200515|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|Vaccine group difference|25.0|||||TWO_SIDED|95.0|9.7|37.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||37.1|9.7|
71125450|NCT01571453|141757452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.11||0.174|TWO_SIDED|95.0|-0.35|0.06||No adjustments for multiple comparisons were made.|ANCOVA|LOCF was used.||The same ANCOVA methodology as for the primary endpoint was used.||0.06|-0.35|0.174
71125451|NCT01571453|141757453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.65||0.207|TWO_SIDED|95.0|-2.09|0.45||No adjustments for multiple comparisons were made.|ANCOVA|LOCF was used.||The same ANCOVA methodology as for the primary endpoint was used.||0.45|-2.09|0.207
71125452|NCT01571453|141757454|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.272||95.0|0.84|1.86||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic|||||1.86|0.84|0.272
71125453|NCT01571453|141757455|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.731||95.0|0.73|1.58||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic|||||1.58|0.73|0.731
71125454|NCT04033068|141757501|SUPERIORITY||||||=|0.2003|||||||Fisher-Freeman-Halton Test|||||||= 0.2003
71125455|NCT04033068|141757502|SUPERIORITY||||||=|0.1448|||||||Fisher-Freeman-Halton Test|||||||= 0.1448
71125456|NCT04033068|141757503|SUPERIORITY||||||=|0.9111|||||||Fisher-Freeman-Halton Test|||||||= 0.9111
71125457|NCT04033068|141757504|SUPERIORITY||||||=|1|||||||Fisher-Freeman-Halton Test|||||||= 1.0000
71125458|NCT04033068|141757506|SUPERIORITY||GMT Ratio|0.9|||=|0.999|TWO_SIDED|95.0|0.2|5.5|||ANOVA|||Day 0||5.5|0.2|= 0.9990
71125459|NCT04033068|141757506|SUPERIORITY||GMT Ratio|0.8|||=|0.9798|TWO_SIDED|95.0|0.1|5.2|||ANOVA|||Day 0||5.2|0.1|= 0.9798
71125460|NCT04033068|141757506|SUPERIORITY||GMT Ratio|1.2|||=|0.9958|TWO_SIDED|95.0|0.1|10.1|||ANOVA|||Day 0||10.1|0.1|= 0.9958
71125461|NCT04033068|141757506|SUPERIORITY||GMT Ratio|0.8|||=|0.9935|TWO_SIDED|95.0|0.1|5.5|||ANOVA|||Day 0||5.5|0.1|= 0.9935
71125462|NCT04033068|141757506|SUPERIORITY||GMT Ratio|1.3|||=|0.9852|TWO_SIDED|95.0|0.2|10.7|||ANOVA|||Day 0||10.7|0.2|= 0.9852
71125463|NCT04033068|141757506|SUPERIORITY||GMT Ratio|1.6|||=|0.944|TWO_SIDED|95.0|0.2|14.4|||ANOVA|||Day 0||14.4|0.2|= 0.9440
71125464|NCT04033068|141757506|SUPERIORITY||GMT Ratio|1.2|||=|0.9943|TWO_SIDED|95.0|0.2|5.5|||ANOVA|||Day 28||5.5|0.2|= 0.9943
71125465|NCT04033068|141757506|SUPERIORITY||GMT Ratio|1.0|||=|0.9999|TWO_SIDED|95.0|0.2|5.1|||ANOVA|||Day 28||5.1|0.2|= 0.9999
71125466|NCT04033068|141757506|SUPERIORITY||GMT Ratio|2.2|||=|0.6476|TWO_SIDED|95.0|0.4|14.3|||ANOVA|||Day 28||14.3|0.4|= 0.6476
71125467|NCT04033068|141757506|SUPERIORITY||GMT Ratio|0.8|||=|0.9911|TWO_SIDED|95.0|0.2|4.3|||ANOVA|||Day 28||4.3|0.2|= 0.9911
71125468|NCT04033068|141757506|SUPERIORITY||GMT Ratio|1.9|||=|0.7647|TWO_SIDED|95.0|0.3|12.0|||ANOVA|||Day 28||12.0|0.3|= 0.7647
71125469|NCT04033068|141757506|SUPERIORITY||GMT Ratio|2.3|||=|0.6447|TWO_SIDED|95.0|0.3|15.8|||ANOVA|||Day 28||15.8|0.3|= 0.6447
71125470|NCT04033068|141757506|SUPERIORITY||GMT Ratio|1.3|||=|0.9638|TWO_SIDED|95.0|0.3|5.3|||ANOVA|||Day 56||5.3|0.3|= 0.9638
71125471|NCT04033068|141757506|SUPERIORITY||GMT Ratio|1.7|||=|0.7837|TWO_SIDED|95.0|0.4|7.7|||ANOVA|||Day 56||7.7|0.4|= 0.7837
71125472|NCT04033068|141757506|SUPERIORITY||GMT Ratio|2.9|||=|0.3427|TWO_SIDED|95.0|0.5|15.3|||ANOVA|||Day 56||15.3|0.5|= 0.3427
71125473|NCT04033068|141757506|SUPERIORITY||GMT Ratio|1.3|||=|0.9578|TWO_SIDED|95.0|0.3|5.8|||ANOVA|||Day 56||5.8|0.3|= 0.9578
71125474|NCT04033068|141757506|SUPERIORITY||GMT Ratio|2.2|||=|0.5637|TWO_SIDED|95.0|0.4|11.7|||ANOVA|||Day 56||11.7|0.4|= 0.5637
71125475|NCT04033068|141757506|SUPERIORITY||GMT Ratio|1.7|||=|0.8471|TWO_SIDED|95.0|0.3|9.6|||ANOVA|||Day 56||9.6|0.3|= 0.8471
71125476|NCT02039856|141757520|SUPERIORITY|Difference-in-differences using ordered logistic regression, adjusting for age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD, and the population weights, which were the product of design weights and non-response weights. We verified that proportional odds assumption was met.|Odds Ratio (OR)|0.913|STANDARD_ERROR_OF_MEAN|0.175||0.637|TWO_SIDED|95.0|0.627|1.33|||difference-in-differences analysis||The estimated value is predicted change in the odds of WH-PACT achievement, adjusting for characteristics described in the statistical analysis overview.|Change in the odds of achieving a higher WH-PACT element.||1.33|0.627|0.637
71125477|NCT02039856|141757521|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for gender, race/ethnicity, years worked at VA, worked in women's health clinic vs general primary care clinic, clinician status vs staff status, fulltime employment, percent of women veterans enrolled at the VA facility. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.|Median Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.1195||0.006|TWO_SIDED|95.0|0.1|0.57|||Regression, Linear||The estimated value reported here is the predicted mean change over time, adjusting for characteristics described in the statistical analysis overview.|Change in gender sensitivity score between EBQI and control over time||0.57|0.10|0.006
71125478|NCT02039856|141757522|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for gender, race/ethnicity, years worked at VA, worked in women's health clinic vs general primary care clinic, clinician status vs staff status, fulltime employment, percent of women veterans enrolled at the VA facility. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.|Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.2253||0.055|TWO_SIDED|95.0|-0.01|0.87|||Regression, Linear||The estimated value reported here is the predicted mean change over time, adjusting for characteristics described in the statistical analysis overview.|Change in team functioning score between EBQI and control over time.||0.87|-0.01|0.055
71125479|NCT02039856|141757523|SUPERIORITY|We adjusted our analysis using the population weights, which were the product of design weights and non-response weights|Odds Ratio (OR)|0.36|STANDARD_ERROR_OF_MEAN|0.1922||0.058|TWO_SIDED|95.0|0.13|1.04|||Regression, Logistic||The estimated value is the predicted mean, adjusting for weights, worked in women's health vs general PC clinic, years worked at the VA, race/ethnicity, gender, full-time employment, and percent of women veterans enrolled at the VA facility.|||1.04|0.13|0.058
71125480|NCT02039856|141757524|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.|Median Difference (Net)|1.25|STANDARD_ERROR_OF_MEAN|0.56||0.008|TWO_SIDED|95.0|0.14|2.36|||Regression, Linear||The estimated value is predicted change in the number of VA primary care visits, adjusting for characteristics described in the statistical analysis overview.|Change in number of patient primary care visits between EBQI and control over time||2.36|0.14|0.008
71125481|NCT02039856|141757525|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for adjusted for survey weights, age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD, and the population weights, which were the product of design weights and non-response weights.|Median Difference (Net)|1.69|STANDARD_ERROR_OF_MEAN|0.413||0|TWO_SIDED|95.0|0.88|2.51|||Regression, Linear||The estimated value is predicted change in the number of VA women's health visits, adjusting for characteristics described in the statistical analysis overview.|Change in number of patient visits to women's health care between EBQI and control over time||2.51|0.88|0.000
71125482|NCT02039856|141757526|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for adjusted for survey weights, age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.|Median Difference (Net)|-0.018|STANDARD_ERROR_OF_MEAN|0.068||0.794|TWO_SIDED|95.0|-0.15|0.12|||Regression, Linear||The estimated value is predicted change in the number of VA hospitalization, adjusting for characteristics described in the statistical analysis overview.|Change in number of patient hospitalization for any cause between EBQI and control over time||0.12|-0.15|0.794
71125483|NCT02039856|141757527|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for adjusted for survey weights, age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.|Median Difference (Net)|0.021|STANDARD_ERROR_OF_MEAN|0.15||0.888|TWO_SIDED|95.0|-0.265|0.306|||Regression, Linear||The estimated value is predicted change in the number of VA emergency room visits, adjusting for characteristics described in the statistical analysis overview.|Change in number of emergency room visits for any cause between EBQI and control over time||0.306|-0.265|0.888
71125484|NCT02409342|141757528|SUPERIORITY|Stratified analysis. OS was tested hierarchically in the efficacy analysis populations.|Hazard Ratio (HR)|0.595||||0.0106|TWO_SIDED|95.0|0.398|0.89|||Log Rank|||TC3 or IC3-WT Population||0.890|0.398|0.0106
71125485|NCT02409342|141757529|SUPERIORITY|Stratified analysis. OS was tested hierarchically in the efficacy analysis populations.|Hazard Ratio (HR)|0.868||||0.3091|TWO_SIDED|95.0|0.661|1.14|||Log Rank|||TC2/3 or IC2/3-WT Population||1.140|0.661|0.3091
71125486|NCT02409342|141757529|SUPERIORITY|Stratified analysis. OS was tested hierarchically in the efficacy analysis populations.|Hazard Ratio (HR)|0.845||||0.107|TWO_SIDED|95.0|0.688|1.037||P-value is descriptive as it was not formally tested.|Log Rank|||TC1/2/3 or IC/1/2/3-WT||1.037|0.688|0.1070
71125487|NCT02409342|141757530|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.63||||0.007|TWO_SIDED|95.0|0.449|0.884||P-value is descriptive as it was not formally tested.|Log Rank|||TC3 or IC3-WT Population||0.884|0.449|0.0070
71125488|NCT02409342|141757531|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.641||||0.0004|TWO_SIDED|95.0|0.501|0.82||P-value is descriptive as it was not formally tested.|Log Rank|||TC2/3 or IC2/3-WT Population||0.820|0.501|0.0004
71125489|NCT02409342|141757531|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.716||||0.0004|TWO_SIDED|95.0|0.595|0.863||P-value is descriptive as it was not formally tested.|Log Rank|||TC1/2/3 or IC1/2/3-WT Population||0.863|0.595|0.0004
71125490|NCT02409342|141757532|SUPERIORITY|Stratified Analysis|Difference in ORR|9.75|||||TWO_SIDED|95.0|-4.07|23.56||||||TC3 or IC3-WT Population||23.56|-4.07|
71125491|NCT02409342|141757533|SUPERIORITY|Stratified analysis|Difference in ORR|1.64|||||TWO_SIDED|95.0|-9.14|12.42||||||TC2/3 or IC2/3-WT Population||12.42|-9.14|
71125492|NCT02409342|141757533|SUPERIORITY|Stratified analysis|Difference in ORR|-0.72|||||TWO_SIDED|95.0|-8.84|7.39||||||TC1/2/3 or IC1/2/3-WT Population||7.39|-8.84|
71125493|NCT02409342|141757534|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.365|||||TWO_SIDED|95.0|0.166|0.8||||||TC3 or IC3-WT Population||0.800|0.166|
71125494|NCT02409342|141757535|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|0.235|||||TWO_SIDED|95.0|0.135|0.409||||||TC2/3 or IC2/3-WT Population||0.409|0.135|
71125495|NCT02409342|141757535|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|0.284|||||TWO_SIDED|95.0|0.19|0.424||||||TC1/2/3 or IC1/2/3-WT Population||0.424|0.190|
71087701|NCT00794664|141681830|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
71087702|NCT00794664|141681832|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inferential conclusions about this parameter require statistical significance of the previous secondary outcome measure (i.e., percent change from baseline in Apo B at PET).|t-test, 2 sided|||||||<0.001
71087703|NCT00794664|141681834|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inferential conclusions about this parameter require statistical significance of the previous secondary outcome measure (i.e., percent change from baseline in total cholesterol at PET).|t-test, 2 sided|||||||<0.001
71087704|NCT00794664|141681836|SUPERIORITY_OR_OTHER|||||||0.034||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||0.034
71087705|NCT00794664|141681838|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||<0.001
71087706|NCT00794664|141681840|SUPERIORITY_OR_OTHER||||||<|0.032||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||<0.032
71087707|NCT00794664|141681842|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤0.05|Wilcoxon rank sum test|||||||<0.001
71087708|NCT00794664|141681844|SUPERIORITY_OR_OTHER|||||||0.278||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||0.278
71087709|NCT00794664|141681846|SUPERIORITY_OR_OTHER|||||||0.647||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||0.647
71087710|NCT01062308|141681848|SUPERIORITY_OR_OTHER||Mean difference from baseline to day 30|-11.8||||0.03|TWO_SIDED|95.0|-22.6|-1.1|||Mixed Models Analysis|||||-1.1|-22.6|0.03
71087711|NCT01062308|141681849|SUPERIORITY_OR_OTHER||Mean difference from baseline to day 30|6.6||||0.16|TWO_SIDED|95.0|-2.7|15.9|||Mixed Models Analysis|||||15.9|-2.7|0.16
71087712|NCT00457730|141681850|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||t-test, 2 sided|||||||0.016
71087713|NCT00457730|141681851|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||||||0.002
71087714|NCT00457730|141681852|SUPERIORITY_OR_OTHER|||||||0.074|TWO_SIDED||||||t-test, 2 sided|||||||0.074
71125496|NCT02409342|141757536|SUPERIORITY||Difference in Event Free Rate|14.26|||||TWO_SIDED|95.0|-0.03|28.55||||||1-Year TC3 or IC3-WT Population||28.55|-0.03|
71087715|NCT01419535|141681868|SUPERIORITY|||||||0.6|||||||ANOVA|Repeated measures were analyzed by repeated-measures ANOVA including treatment group, time, and treatment\*time interaction as factors.||||||0.60
71087716|NCT01419535|141681869|SUPERIORITY||||||<|0.001|||||||ANOVA|Repeated measures were analyzed by repeated-measures ANOVA including treatment group, time, and treatment\*time interaction as factors.||||||<0.001
71087717|NCT01419535|141681870|SUPERIORITY||||||<|0.001|||||||ANOVA|Repeated measures were analyzed by repeated-measures ANOVA including treatment group, time, and treatment\*time interaction as factors.||||||<0.001
71087718|NCT01419535|141681871|SUPERIORITY||||||<|0.001|||||||ANOVA|Repeated measures were analyzed by repeated-measures ANOVA including treatment group, time, and treatment\*time interaction as factors.||||||<0.001
71087719|NCT01419535|141681872|SUPERIORITY|||||||0.004|||||||ANOVA|Repeated measures were analyzed by repeated-measures ANOVA including treatment group, time, and treatment\*time interaction as factors.||||||0.004
71087720|NCT01419535|141681873|SUPERIORITY|||||||0.002|||||||ANOVA|Repeated measures were analyzed by repeated-measures ANOVA including treatment group, time, and treatment\*time interaction as factors.||||||0.002
71087721|NCT02100124|141681889|SUPERIORITY||Odds Ratio (OR)|0.87||||1|TWO_SIDED|95.0|0.56|1.36|||Regression, Logistic|||||1.36|0.56|1.0
71087722|NCT02100124|141681889|SUPERIORITY||Odds Ratio (OR)|1.13||||1|TWO_SIDED|95.0|0.7|1.83|||Regression, Logistic|||||1.83|0.70|1.0
71087723|NCT02100124|141681889|SUPERIORITY||Odds Ratio (OR)|1.3||||0.53|TWO_SIDED|95.0|0.82|2.08|||Regression, Logistic|||||2.08|0.82|0.53
71087724|NCT02100124|141681890|SUPERIORITY||Odds Ratio (OR)|0.88||||0.48|TWO_SIDED|95.0|0.71|1.09|||Regression, Logistic|||||1.09|0.71|0.48
71087725|NCT02100124|141681890|SUPERIORITY||Odds Ratio (OR)|1.08||||1|TWO_SIDED|95.0|0.87|1.35|||Regression, Logistic|||||1.35|0.87|1.0
71087726|NCT02100124|141681890|SUPERIORITY||Odds Ratio (OR)|1.23||||0.07|TWO_SIDED|95.0|0.99|1.53|||Regression, Logistic|||||1.53|0.99|0.07
71087727|NCT02100124|141681891|SUPERIORITY||Odds Ratio (OR)|1.04||||1|TWO_SIDED|95.0|0.84|1.29|||Regression, Logistic|||||1.29|0.84|1.0
71087728|NCT02100124|141681891|SUPERIORITY||Odds Ratio (OR)|1.02||||1|TWO_SIDED|95.0|0.82|1.26|||Regression, Logistic|||||1.26|0.82|1.0
71087729|NCT02100124|141681891|SUPERIORITY||Odds Ratio (OR)|0.98||||1|TWO_SIDED|95.0|0.79|1.22|||Regression, Logistic|||||1.22|0.79|1.0
71087730|NCT02100124|141681892|SUPERIORITY||Odds Ratio (OR)|1.07||||1|TWO_SIDED|95.0|0.83|1.37|||Regression, Logistic|||||1.37|0.83|1.0
71087731|NCT02100124|141681892|SUPERIORITY||Odds Ratio (OR)|1.04||||1|TWO_SIDED|95.0|0.81|1.33|||Regression, Logistic|||||1.33|0.81|1.0
71087732|NCT02100124|141681892|SUPERIORITY||Odds Ratio (OR)|0.97||||1|TWO_SIDED|95.0|0.75|1.25|||Regression, Logistic|||||1.25|0.75|1.0
71087733|NCT01926028|141681932|EQUIVALENCE|The proportion of patients in each group was summarized with point estimates and their 95% confidence interval|Cox Proportional Hazard|0.39||||0.03|TWO_SIDED|95.0|0.17|0.91|||Wilcoxon (Mann-Whitney)|||||0.91|0.17|0.03
71087734|NCT01926028|141681933|EQUIVALENCE|The proportion of patients in each group was summarized with point estimates and their 95% confidence interval|Cox Proportional Hazard|0.55||||0.1|TWO_SIDED|95.0|0.27|1.13|||Wilcoxon (Mann-Whitney)|||||1.13|0.27|0.10
71087735|NCT01130272|141681942|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.457||||0.052|TWO_SIDED|95.0|0.994|6.077|||ANCOVA|||||6.077|0.994|0.052
71087736|NCT01130272|141681942|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.383||||0.041|TWO_SIDED|95.0|1.036|5.478|||ANCOVA|||||5.478|1.036|0.041
71087737|NCT01130272|141681942|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.079||||0.09|TWO_SIDED|95.0|0.893|4.842|||ANCOVA|||||4.842|0.893|0.090
70945860|NCT00878553|141392783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.153|STANDARD_ERROR_OF_MEAN|2.422||0.0077|TWO_SIDED|95.0|-15.857|-2.448||Change from baseline in mean WASO3-7 compared values for the 20-mg dose vs. placebo. If that comparison demonstrated superiority of the 20-mg dose, then results for the 15-mg dose vs. placebo were compared; if significant, then 10-mg vs. placebo.|Mixed Models Analysis|This hierarchical, 2-sided testing procedure maintained the overall level of significance at approximately 0.05.|Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment. A negative mean change from baseline indicates an improvement|Literature-based estimates of WASO SD range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 20-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes.||-2.448|-15.857|0.0077
70945861|NCT00878553|141392784|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.604|STANDARD_ERROR_OF_MEAN|2.755||0.1476|TWO_SIDED|95.0|-13.208|2.0||Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|Literature-based estimates of WASO (Wake After Sleep Onset) SD (Standard Deviation) range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 15-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes.||2.000|-13.208|0.1476
70945862|NCT00878553|141392784|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.912|STANDARD_ERROR_OF_MEAN|2.757||0.0757|TWO_SIDED|95.0|-14.546|0.722||Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|Literature-based estimates of WASO (Wake After Sleep Onset) SD (Standard Deviation) range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 15-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes.||0.722|-14.546|0.0757
71125497|NCT02409342|141757537|SUPERIORITY||Difference in Event Free Rate|20.7|||||TWO_SIDED|95.0|2.94|38.47||||||2-Years TC3 or IC3-WT Population||38.47|2.94|
71125498|NCT02409342|141757538|SUPERIORITY||Difference in Event Free Rate|4.74|||||TWO_SIDED|95.0|-5.93|15.4||||||1-Year TC2/3 or IC2/3-WT Population||15.40|-5.93|
71125499|NCT02409342|141757538|SUPERIORITY||Difference in Event Free Rate|5.06|||||TWO_SIDED|95.0|-3.27|13.4||||||1-Year TC1/2/3 or IC1/2/3-WT Population||13.40|-3.27|
71125500|NCT02409342|141757539|SUPERIORITY||Difference in Event Free Rate|8.73|||||TWO_SIDED|95.0|-1.99|19.45||||||2-Years TC2/3 or IC2/3-WT Population||19.45|-1.99|
71125501|NCT02409342|141757539|SUPERIORITY||Difference in Event Free Rate|10.94|||||TWO_SIDED|95.0|2.83|19.04||||||2-Years TC1/2/3 or IC1/2/3-WT Population||19.04|2.83|
71125502|NCT02409342|141757540|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.142|||||TWO_SIDED|95.0|0.657|1.984||||||Cough in TC3 or IC3-WT Populations||1.984|0.657|
71125503|NCT02409342|141757540|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|0.891|||||TWO_SIDED|95.0|0.555|1.43||||||Dyspnoea in TC3 or IC3-WT Populations||1.430|0.555|
71125504|NCT02409342|141757540|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|1.229|||||TWO_SIDED|95.0|0.737|2.049||||||Chest pain in TC3 or IC3-WT Populations||2.049|0.737|
71125505|NCT02409342|141757542|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|0.984|||||TWO_SIDED|95.0|0.477|2.03||||||Cough for TC3 or IC3-WT Populations||2.030|0.477|
71125506|NCT02409342|141757542|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|0.955|||||TWO_SIDED|95.0|0.569|1.604||||||Dyspnea for TC3 or IC3-WT Populations||1.604|0.569|
71125507|NCT02409342|141757542|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|1.024|||||TWO_SIDED|95.0|0.472|2.222||||||Chest pain for TC3 or IC3-WT Populations||2.222|0.472|
71125508|NCT02409342|141757543|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.707|||||TWO_SIDED|95.0|0.5|1.0||||||SP263 \>=50%-WT Population||1.000|0.500|
71125509|NCT02409342|141757543|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.693|||||TWO_SIDED|95.0|0.502|0.956||||||SP263 \>=25%-WT Population||0.956|0.502|
71125510|NCT02409342|141757543|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.768|||||TWO_SIDED|95.0|0.579|1.018||||||SP263 \>=1%-WT Population||1.018|0.579|
71125511|NCT02409342|141757544|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.674|||||TWO_SIDED|95.0|0.511|0.89||||||SP263 \>=50%-WT Population||0.890|0.511|
71125512|NCT02409342|141757544|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.698|||||TWO_SIDED|95.0|0.539|0.904||||||SP263 \>=25%-WT Population||0.904|0.539|
71125513|NCT02409342|141757544|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.725|||||TWO_SIDED|95.0|0.577|0.91||||||SP263 \>=1%-WT Population||0.910|0.577|
71125514|NCT02409342|141757545|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.867|||||TWO_SIDED|95.0|0.578|1.301||||||bTMB \>=10-WT Population||1.301|0.578|
70945863|NCT00878553|141392784|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.521|STANDARD_ERROR_OF_MEAN|2.757||0.1553|TWO_SIDED|95.0|-13.154|2.113||Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|Literature-based estimates of WASO (Wake After Sleep Onset) SD (Standard Deviation) range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 15-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes.||2.113|-13.154|0.1553
70945864|NCT00878553|141392785|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.831|STANDARD_ERROR_OF_MEAN|2.4||0.0092|TWO_SIDED|95.0|2.208|15.454||All aspects of the study's primary endpoint were statistically significant, and no adjustment for multiple testing was made for secondary efficacy endpoints.|Mixed Models Analysis||A positive mean difference from baseline indicates an improvement.|The adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence, and treatment.||15.454|2.208|0.0092
70945865|NCT00878553|141392785|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.425|STANDARD_ERROR_OF_MEAN|2.402||0.0023|TWO_SIDED|95.0|3.775|17.075||All aspects of the study's primary endpoint were statistically significant, and no adjustment for multiple testing was made for secondary efficacy endpoints.|Mixed Models Analysis||A positive mean difference from baseline indicates an improvement.|The adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence, and treatment.||17.075|3.775|0.0023
71125515|NCT02409342|141757545|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.748|||||TWO_SIDED|95.0|0.414|1.351||||||bTMB \>=16-WT Population||1.351|0.414|
71125516|NCT02409342|141757545|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.362|1.638||||||bTMB \>=20-WT Population||1.638|0.362|
71125517|NCT02409342|141757546|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.743|||||TWO_SIDED|95.0|0.525|1.052||||||bTMB \>=10-WT Population||1.052|0.525|
71125518|NCT02409342|141757546|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.553|||||TWO_SIDED|95.0|0.331|0.924||||||bTMB \>=16-WT Population||0.924|0.331|
71125519|NCT02409342|141757546|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.295|1.062||||||bTMB \>=20-WT Population||1.062|0.295|
71125520|NCT01280695|141757554|SUPERIORITY_OR_OTHER||Median Difference (Net)|-10.0||||0.4195|TWO_SIDED|95.0|-34.0|14.0|||Wilcoxon (Mann-Whitney)|||||14.0|-34.0|0.4195
71125521|NCT01280695|141757554|SUPERIORITY_OR_OTHER||Median Difference (Net)|-18.0||||0.0811|TWO_SIDED|95.0|-38.0|4.0|||Wilcoxon (Mann-Whitney)|||||4.0|-38.0|0.0811
71125522|NCT01280695|141757554|SUPERIORITY_OR_OTHER||Median Difference (Net)|-20.0||||0.0639|TWO_SIDED|95.0|-38.0|1.0|||Wilcoxon (Mann-Whitney)|||||1.0|-38.0|0.0639
71125523|NCT01280695|141757554|SUPERIORITY_OR_OTHER||Median Difference (Net)|-32.0||||0.0022|TWO_SIDED|95.0|-50.0|-12.0|||Wilcoxon (Mann-Whitney)|||||-12.0|-50.0|0.0022
71125524|NCT01364740|141757567|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Sign test|||Patient data from one night with the PMP-300E compared to In-Lab PSG data||||>0.05
71125525|NCT01364740|141757568|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Sign test|||Patient data from one night with the PMP-300E compared to In-Lab PSG data||||>0.05
71125526|NCT01364740|141757569|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Sign test|||Patient data from one night with the PMP-300E compared to In-Lab PSG data||||>0.05
71125527|NCT01364740|141757570|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Sign test|||Patient data from one night with the PMP-300E compared to In-Lab PSG data||||>0.05
70945866|NCT00878553|141392785|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.147|STANDARD_ERROR_OF_MEAN|2.402||0.003|TWO_SIDED|95.0|3.498|16.796||All aspects of the study's primary endpoint were statistically significant, and no adjustment for multiple testing was made for secondary efficacy endpoints.|Mixed Models Analysis||A positive mean difference from baseline indicates an improvement.|The adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence, and treatment.||16.796|3.498|0.0030
70945867|NCT00878553|141392786|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.562|STANDARD_ERROR_OF_MEAN|0.244||0.1005|TWO_SIDED|95.0|-1.235|0.11||Adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period,sequence, and treatment.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|This endpoint summarizes the number of times during Hours 3 7, after onset of persistent sleep, that there was a wake entry of at least 2 epochs duration. To be counted, each entry must have been separated by a sleep stage of 2, 3 4, or rapid eye movement.||0.110|-1.235|0.1005
70945868|NCT00878553|141392786|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.037|STANDARD_ERROR_OF_MEAN|0.244||0.0028|TWO_SIDED|95.0|-1.712|-0.362||Adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period,sequence, and treatment.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary endpoints.|A negative mean change from baseline indicates an improvement.|This endpoint summarizes the number of times during Hours 3 7, after onset of persistent sleep, that there was a wake entry of at least 2 epochs duration. To be counted, each entry must have been separated by a sleep stage of 2, 3 4, or rapid eye movement.||-0.362|-1.712|0.0028
71087738|NCT01130272|141681942|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.797||||0.015|TWO_SIDED|95.0|1.227|6.376|||ANCOVA|||||6.376|1.227|0.015
71087739|NCT01130272|141681943|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.719||||0.449|TWO_SIDED|95.0|0.306|1.689|||ANCOVA|||||1.689|0.306|0.449
71087740|NCT01130272|141681943|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.208||||0.583|TWO_SIDED|95.0|0.615|2.373|||ANCOVA|||||2.373|0.615|0.583
71087741|NCT01130272|141681943|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.014||||0.03|TWO_SIDED|95.0|1.069|3.795|||ANCOVA|||||3.795|1.069|0.030
71087742|NCT01130272|141681943|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.395||||0.326|TWO_SIDED|95.0|0.717|2.716|||ANCOVA|||||2.716|0.717|0.326
71087743|NCT00641056|141681957|NON_INFERIORITY_OR_EQUIVALENCE|Power: 205 patients per treatment group would provide approximately 92% power to detect a true difference between treatments of 0.4% in change in HbA1c from baseline with a 2-sided t test at a significance level of 0.05, assuming a common standard deviation of 1.2%.|Least Squares Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.017|TWO_SIDED|95.0|-0.29|-0.03||No adjustments for multiplicity were performed|Mixed Models Analysis|||Mixed-model Repeated Measures (MMRM) Analysis of Covariance (ANCOVA) model includes treatment, baseline HbA1c, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects. Superiority of exenatide once weekly to insulin glargine is concluded if the upper limit of the 95% confidence interval for the treatment difference \[exenatide once weekly-insulin glargine\]\<0; noninferiority is concluded if this upper limit\<0.3%.||-0.03|-0.29|0.017
71087744|NCT00641056|141681958|SUPERIORITY_OR_OTHER|||||||0.097|TWO_SIDED|95.0||||No adjustments for multiplicity were performed|Cochran-Mantel-Haenszel|||Percentage of patients achieving HbA1c \<=7.0% at Week 26 were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which background OAD and country served as the stratification factors.||||0.097
71087745|NCT00641056|141681959|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|95.0||||No adjustments for multiplicity were performed|Cochran-Mantel-Haenszel|||Percentage of patients achieving HbA1c \<=6.5% at Week 26 were compared between treatments using a CMH test, in which background OAD and country served as the stratification factors.||||0.002
71125528|NCT00568126|141757601|SUPERIORITY|Remission rates for maca vs. placebo were compared by chi-squared and by odds ratio (with 95% confidence interval).|Odds Ratio (OR)|2.1||||0.55|TWO_SIDED|95.0|0.18|25.2||P values above are calculated. No multiple comparisons. Threshold for significance set a priori as P\<0.05.|Chi-squared||Odds ratio for attaining remission while taking maca vs taking placebo|"Treatment groups were compared based on percentage reaching remission thresholds per scale: a total score of 12 (minimally diminished) or less on the MGH-SFQ scale, and a total score of 10 (very strong/very easily/very satisfying) or less on the ASEX."||25.2|0.18|0.55
71125529|NCT00568126|141757602|SUPERIORITY|Remission rates for maca vs. placebo were compared by chi-squared and by odds ratio (with 95% confidence interval).|Odds Ratio (OR)|1.71||||0.47|TWO_SIDED|95.0|0.4|7.34||P values above are calculated. No multiple comparisons. Threshold for significance set a priori as P\<0.05.|Chi-squared||Odds ratio for attaining remission while taking maca vs taking placebo|"Treatment groups were compared based on percentage reaching remission thresholds per scale: a total score of 12 (minimally diminished) or less on the MGH-SFQ scale, and a total score of 10 (very strong/very easily/very satisfying) or less on the ASEX."||7.34|0.40|0.47
71125530|NCT02883062|141757628|SUPERIORITY|||||||0.36|||||||Generalized estimating equation (GEE)|||||||0.36
71125531|NCT02883062|141757629|SUPERIORITY|||||||0.018|||||||Regression, Logistic|||||||0.018
71125532|NCT02888743|141757637|SUPERIORITY||Difference between proportions|0.0||||0.99|TWO_SIDED|90.0|-14.6|14.6|||Chi-squared||Arm A compared with Arm C; normal approximation for confidence interval|||14.6|-14.6|0.99
70945869|NCT00878553|141392786|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.793|STANDARD_ERROR_OF_MEAN|0.244||0.0216|TWO_SIDED|95.0|-1.467|-0.118||Adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period,sequence, and treatment.|Mixed Models Analysis|No adjustments for multiple testing were made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|This endpoint summarizes the number of times during Hours 3 7, after onset of persistent sleep, that there was a wake entry of at least 2 epochs duration. To be counted, each entry must have been separated by a sleep stage of 2, 3 4, or rapid eye movement.||-0.118|-1.467|0.0216
70945870|NCT00878553|141392787|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.452|STANDARD_ERROR_OF_MEAN|0.219||0.219|TWO_SIDED|95.0|-21.98|5.077||Mean (SEM) = adjusted mean change from baseline in each group (and standard error of the mean) and P value = P value for the comparison of the SEM of the active group with that of the placebo group.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|Study was powered on the primary endpoint. Data for sWASO were sourced from Question 5 of the Morning Sleep Questionnaire. Its analysis follows a general linear model change from baseline as response variable including effects for patient, period, sequence, and treatment.||5.077|-21.980|0.2190
70945871|NCT00878553|141392787|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.365|STANDARD_ERROR_OF_MEAN|4.937||0.8441|TWO_SIDED|95.0|-12.327|15.056||Mean (SEM) = adjusted mean change from baseline in each group (and standard error of the mean) and P value = P value for the comparison of the SEM of the active group with that of the placebo group.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A positive mean change from baseline indicates a worsening.|Study was powered on the primary endpoint. Data for sWASO were sourced from Question 5 of the Morning Sleep Questionnaire. Its analysis follows a general linear model change from baseline as response variable including effects for patient, period, sequence, and treatment.||15.056|-12.327|0.8441
71125533|NCT02888743|141757637|SUPERIORITY||Difference between proportions|-3.8||||0.64|TWO_SIDED|90.0|-17.3|9.6|||Chi-squared||Arm B compared with Arm C; normal approximation used for confidence interval.|||9.6|-17.3|0.64
71125534|NCT02888743|141757638|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.92|TWO_SIDED|90.0|0.6|1.58|||Regression, Cox|||||1.58|0.60|0.92
71125535|NCT02888743|141757638|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.55|TWO_SIDED|90.0|0.5|1.38|||Regression, Cox|||||1.38|0.50|0.55
71125536|NCT02888743|141757639|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.24|TWO_SIDED|90.0|0.3|1.22|||Regression, Cox|||||1.22|0.30|0.24
71125537|NCT02888743|141757639|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.44|TWO_SIDED|90.0|0.36|1.45|||Regression, Cox|||||1.45|0.36|0.44
71125538|NCT02888743|141757643|SUPERIORITY|||||||0.68||||||Unadjusted p-value.|Wilcoxon (Mann-Whitney)|||||||0.68
71125539|NCT01424566|141757646|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.9173|TWO_SIDED|95.0|-0.42|0.38|||ANCOVA|||||0.38|-0.42|0.9173
71125540|NCT04816721|141757659|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-0.96||||0.1249|TWO_SIDED|95.0|-2.21|0.28|||Mixed-effect Model of Repeated Measures|||Day 3: EDP-938 Versus Placebo||0.28|-2.21|0.1249
71125541|NCT04816721|141757659|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-1.41||||0.058|TWO_SIDED|95.0|-2.88|0.05|||Mixed-effect Model of Repeated Measures|||Day 5: EDP-938 Versus Placebo||0.05|-2.88|0.0580
71125542|NCT04816721|141757659|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-0.43||||0.5877|TWO_SIDED|95.0|-2.02|1.16|||Mixed-effect Model of Repeated Measures|||Day 9: EDP-938 Versus Placebo||1.16|-2.02|0.5877
71125543|NCT04816721|141757659|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|0.84||||0.2932|TWO_SIDED|95.0|-0.76|2.43|||Mixed-effect Model of Repeated Measures|||Day 14: EDP-938 Versus Placebo||2.43|-0.76|0.2932
71125544|NCT04816721|141757660|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-0.17||||0.6574|TWO_SIDED|95.0|-0.93|0.59|||Mixed-effect Model of Repeated Measures|||Day 3: EDP-938 Versus Placebo||0.59|-0.93|0.6574
71125545|NCT04816721|141757660|SUPERIORITY||Least Squares Mean Difference|-0.33||||0.4728|TWO_SIDED|95.0|-1.23|0.58|||Mixed-effect Model of Repeated Measures|||Day 5: EDP-938 Versus Placebo||0.58|-1.23|0.4728
71125546|NCT04816721|141757660|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-0.7||||0.2058|TWO_SIDED|95.0|-1.79|0.39|||Mixed-effect Model of Repeated Measures|||Day 9: EDP-938 Versus Placebo||0.39|-1.79|0.2058
70857192|NCT02446743|141200515|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|Vaccine group difference|37.0|||||TWO_SIDED|95.0|25.1|47.0|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||47.0|25.1|
70945872|NCT00878553|141392787|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.84|STANDARD_ERROR_OF_MEAN|4.936||0.0894|TWO_SIDED|95.0|-25.522|1.842||Mean (SEM) = adjusted mean change from baseline in each group (and standard error of the mean) and P value = P value for the comparison of the SEM of the active group with that of the placebo group.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|Study was powered on the primary endpoint. Data for sWASO were sourced from Question 5 of the Morning Sleep Questionnaire. Its analysis follows a general linear model change from baseline as response variable including effects for patient, period, sequence, and treatment.||1.842|-25.522|0.0894
70945873|NCT00878553|141392788|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56|STANDARD_ERROR_OF_MEAN|1.469||0.6433|TWO_SIDED|95.0|-1.823|2.943||Analysis included effects for patient, period, sequence and treatment.|Mixed Models Analysis||A positive mean difference from baseline indicates improvement.|Adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable.||2.943|-1.823|0.6433
70945874|NCT00878553|141392788|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.912|STANDARD_ERROR_OF_MEAN|1.523||0.1167|TWO_SIDED|95.0|-4.304|0.481||Analysis included effects for patient, period, sequence and treatment|Mixed Models Analysis||A negative mean difference from baseline indicates a worsening.|Adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable.||0.481|-4.304|0.1167
70945875|NCT00878553|141392788|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.434|STANDARD_ERROR_OF_MEAN|1.626||0.2385|TWO_SIDED|95.0|-0.958|3.826||Analysis included effects for patient, period, sequence and treatment.|Mixed Models Analysis||A positive mean difference from baseline indicates improvement.|Adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable.||3.826|-0.958|0.2385
71087746|NCT00641056|141681960|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.19||0.001|TWO_SIDED|95.0|0.25|1.0||No adjustments for multiplicity were performed|Mixed Models Analysis|||MMRM ANCOVA with change in FSG as the dependent variable; treatment, baseline FSG, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects.||1.00|0.25|0.001
70857193|NCT02446743|141200515|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|Vaccine group difference|3.0|||||TWO_SIDED|95.0|-3.9|7.6|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||7.6|-3.9|
70945876|NCT00878553|141392789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.45|STANDARD_ERROR_OF_MEAN|0.256||0.0914|TWO_SIDED|95.0|-0.073|0.972|||Mixed Models Analysis||A positive mean change from baseline indicates an improvement.|The adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence and treatment.||0.972|-0.073|0.0914
70945877|NCT00878553|141392789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.165|STANDARD_ERROR_OF_MEAN|0.259||0.536|TWO_SIDED|95.0|-0.36|0.69|||Mixed Models Analysis||A positive mean change from baseline indicates an improvement.|The adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence and treatment.||0.690|-0.360|0.5360
70945878|NCT00878553|141392789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.262|STANDARD_ERROR_OF_MEAN|0.237||0.3254|TWO_SIDED|95.0|-0.787|0.263|||Mixed Models Analysis||A negative mean change from baseline indicates a worsening.|The adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence and treatment.||0.263|-0.787|0.3254
71087747|NCT00641056|141681961|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.05|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-4.57|-3.52||No adjustments for multiplicity were performed|Mixed Models Analysis|||MMRM ANCOVA with change in BW as the dependent variable; treatment, baseline BW, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects.||-3.52|-4.57|<.001
71087748|NCT00641056|141681962|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.07||0.292|TWO_SIDED|95.0|-0.21|0.06||No adjustments for multiplicity were performed|Mixed Models Analysis|||MMRM ANCOVA with change in total cholesterol as the dependent variable; treatment, baseline total cholesterol, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects.||0.06|-0.21|0.292
71087749|NCT00641056|141681963|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.377|TWO_SIDED|95.0|-0.05|0.02||No adjustments for multiplicity were performed|Mixed Models Analysis|||MMRM ANCOVA with change in HDL as the dependent variable; treatment, baseline HDL, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects.||0.02|-0.05|0.377
71087750|NCT00641056|141681964|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|1.07|STANDARD_ERROR_OF_MEAN|0.04||0.077|TWO_SIDED|95.0|0.99|1.15||No adjustments for multiplicity were performed|Mixed Models Analysis|||Triglycerides data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed by MMRM ANCOVA with change in triglycerides as the dependent variable; treatment, baseline triglycerides, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects.||1.15|0.99|0.077
70857194|NCT02446743|141200515|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|Vaccine group difference|28.0|||||TWO_SIDED|95.0|20.2|36.6|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||36.6|20.2|
70945879|NCT00878553|141392790|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.71|STANDARD_ERROR_OF_MEAN|1.818||0.719|TWO_SIDED|95.0|-3.175|4.595||Adjusted mean differences were analyzed in a general linear model that used change from baseline as the response variable.|Mixed Models Analysis|The Model included effects for patient, period, sequence and treatment.|A positive mean change from baseline indicates improvement.|||4.595|-3.175|0.7190
71087751|NCT00737048|141681967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3|STANDARD_DEVIATION|8.06|<|0.0001|||||||Fisher Least Signiﬁcant Diﬀerence Method|||Statistical Analysis 1 for Total pain relief based on numerical rating scale score||||<0.0001
71087752|NCT00737048|141681967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3|STANDARD_DEVIATION|7.99|<|0.0001|||||||Fisher Least Signiﬁcant Diﬀerence Method|||Statistical Analysis 2 for Total pain relief based on numerical rating scale score||||<0.0001
70945880|NCT00878553|141392790|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.821|STANDARD_ERROR_OF_MEAN|2.422||0.6784|TWO_SIDED|95.0|-3.08|4.722||Adjusted mean differences were analyzed in a general linear model that used change from baseline as the response variable.|Mixed Models Analysis|The Model included effects for patient, period, sequence and treatment.|A positive mean change from baseline indicates an improvement.|||4.722|-3.080|0.6784
71087753|NCT01674725|141681996|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333 treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 64% to achieve noninferiority.|Percentage of Participants|100.0|||||TWO_SIDED|95.0|95.9|100.0|||||95% CI was calculated using the Wilson score method for the single proportion because the point estimate was 100%.|Planned enrollment is 210 to allow ≥200 GT1b-infected participants to be treated with combination formulation of ABT-450/r/ABT-267 and ABT-333 with and without RBV. Enrollment terminated after 187 participants were randomized. Assuming a rate of 82% in each arm, a sample size of 90 participants per arm will have \>90% power to demonstrate noninferiority of each arm to the historical rate based on the normal approximation of a single binomial proportion in a one-sample test for superiority.||100.0|95.9|
71087754|NCT01674725|141681996|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 64% to achieve noninferiority.|Percentage of Participants|97.7|||||TWO_SIDED|95.0|94.6|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution.|Assuming a rate of 82% in each arm, a sample size of 90 participants per arm will have \>90% power to demonstrate noninferiority of each arm to the historical rate based on the normal approximation of a single binomial proportion in a one-sample test for superiority.||100.0|94.6|
71087755|NCT01674725|141681997|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||||||<0.001
70857195|NCT02446743|141200515|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|Vaccine group difference|42.0|||||TWO_SIDED|95.0|31.0|51.9|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||51.9|31.0|
70857196|NCT03718299|141200523|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Week 52||||<0.001
70857197|NCT03718299|141200524|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|||||||0.011
70857198|NCT03718299|141200525|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70857199|NCT03718299|141200526|SUPERIORITY||Clopper-Pearson|62.2|||||TWO_SIDED|95.0|46.5|76.2||||||||76.2|46.5|
70857200|NCT03718299|141200527|SUPERIORITY||Clopper-Pearson|93.3|||||TWO_SIDED|95.0|81.7|98.6||||||||98.6|81.7|
70857201|NCT03718299|141200528|SUPERIORITY||Clopper-Pearson|78.9|||||TWO_SIDED|95.0|62.7|90.4||||||||90.4|62.7|
70857202|NCT03718299|141200529|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70857203|NCT03718299|141200530|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71087756|NCT01674725|141681998|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|97.7|||||TWO_SIDED|95.0|94.6|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority.|||100.0|94.6|
71087757|NCT01674725|141681998|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|100.0|||||TWO_SIDED|95.0|95.9|100.0|||||95% CI was calculated using the Wilson score method for the single proportion; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority|||100|95.9|
71087758|NCT01674725|141681998|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333 treatment group as compared with the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group was analyzed using a noninferiority margin of -10.5%; the lower confidence bound of the 2-sided 95% confidence interval for the difference in percentage of participants with sustained virologic response at 12 weeks after treatment must exceed -10.5% to achieve noninferiority.|Percentage of Participants|2.3|||||TWO_SIDED|95.0|-0.8|5.4|||||95% CI was calculated using the normal approximation to the binomial distribution.|||5.4|-0.8|
71125547|NCT04816721|141757660|OTHER|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|0.33||||0.5391|TWO_SIDED|95.0|-0.74|1.41|||Mixed-effect Model of Repeated Measures|||Day 14: EDP-938 Versus Placebo||1.41|-0.74|0.5391
71125548|NCT04816721|141757662|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-0.17||||0.6574|TWO_SIDED|95.0|-0.93|0.59|||Mixed-effect Model of Repeated Measures|||Day 1 through Day 3: EDP-938 Versus Placebo||0.59|-0.93|0.6574
71125549|NCT04816721|141757662|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-0.67||||0.5359|TWO_SIDED|95.0|-2.81|1.47|||Mixed-effect Model of Repeated Measures|||Day 1 through Day 5: EDP-938 Versus Placebo||1.47|-2.81|0.5359
71125550|NCT04816721|141757662|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-2.73||||0.3029|TWO_SIDED|95.0|-7.95|2.5|||Mixed-effect Model of Repeated Measures|||Day 1 through Day 9: EDP-938 Versus Placebo||2.50|-7.95|0.3029
71125551|NCT04816721|141757662|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-3.64||||0.3871|TWO_SIDED|95.0|-11.98|4.69|||Mixed-effect Model of Repeated Measures|||Day 1 through Day 14: EDP-938 Versus Placebo||4.69|-11.98|0.3871
71125552|NCT00026312|141757690|SUPERIORITY_OR_OTHER_LEGACY||Log Rank Test Statistic|2.6803||||0.1016|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients randomized to Regimen A - RA Only and randomized to Regimen B - RA + Immunotherapy were compared using the log-rank test.||||0.1016
71125553|NCT00026312|141757691|SUPERIORITY_OR_OTHER_LEGACY||Log Rank Test Statistic|2.6176||||0.1057|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients randomized to Regimen A - RA Only and randomized to Regimen B - RA + Immunotherapy for the subgroup of patients with INSS Stage 4 disease were compared using the log-rank test.||||0.1057
71125554|NCT00026312|141757694|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.0262|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||The number of courses of therapy delivered or patients randomized to Regimen B - RA + Immunotherapy and non-randomly assigned to Regimen B after halting of randomization, excluding patients with persistent disease, were compared using the Wilcoxon rank-sum test.||||0.0262
70857204|NCT03718299|141200531|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70857205|NCT03718299|141200532|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71087759|NCT02900352|141682001|SUPERIORITY|||||||0.013|||||||Mixed Models Analysis|||||||0.0130
71087760|NCT02900352|141682002|SUPERIORITY|||||||0.148|||||||Chi-squared|||||||0.148
71087761|NCT02900352|141682003|SUPERIORITY|||||||0.054|||||||ANOVA|||||||.054
71087762|NCT02900352|141682004|SUPERIORITY|||||||0.035|||||||Mixed Models Analysis|||||||0.035
71087763|NCT02900352|141682005|SUPERIORITY|||||||0.889|||||||ANOVA|||||||0.889
71087764|NCT02900352|141682006|SUPERIORITY|||||||0.482|||||||ANOVA|||||||0.482
71087765|NCT02900352|141682007|SUPERIORITY|||||||0.04|||||||ANOVA|||||||0.04
70945881|NCT00878553|141392790|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.314|STANDARD_ERROR_OF_MEAN|2.058||0.2433|TWO_SIDED|95.0|-1.586|6.214||Adjusted mean differences were analyzed in a general linear model that used change from baseline as the response variable.|Mixed Models Analysis|The Model included effects for patient, period, sequence and treatment.|A positive mean change from baseline indicates an improvement.|||6.214|-1.586|0.2433
70945882|NCT00878553|141392791|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.39||||0.0009|TWO_SIDED||||||ANOVA|F-test 2 degrees of freedom||Cmax(ng/mL) \[Maximum plasma zaleplon concentration\]||||0.0009
70945883|NCT00878553|141392792|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.9142||95.0|||||ANOVA|F-test two degrees of freedom||Cmax normalized per dose||||0.9142
70945884|NCT00878553|141392793|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.24||||0.1193||95.0|||||ANOVA|F-test 2 degrees of freedom||Time (hour)post-dose of maximum plasma zaleplon concentration||||0.1193
70857206|NCT03718299|141200533|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70857207|NCT03718299|141200534|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70857208|NCT03718299|141200535|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70945885|NCT00878553|141392794|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.85||||0.0003||95.0|||||ANOVA|F-test 2 degrees of freedom||AUC ng\*h/mL)||||0.0003
70945886|NCT00878553|141392795|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.28||||0.2281||95.0|||||ANOVA|F-test 2 degrees of freedom||AUC/Dose (ng\*h/mL/mg)||||0.2281
70857209|NCT03718299|141200536|SUPERIORITY||Mean (Clopper-Pearson)|24.4|||||TWO_SIDED|95.0|12.9|39.5||||||||39.5|12.9|
70857210|NCT03718299|141200537|SUPERIORITY||Mean (Clopper-Pearson)|17.8|||||TWO_SIDED|95.0|8.0|32.1||||||||32.1|8.0|
70857211|NCT03718299|141200538|SUPERIORITY||Clopper-Pearson|48.9|||||TWO_SIDED|95.0|33.7|64.2||||||||64.2|33.7|
70857212|NCT03718299|141200539|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Total Activity Impairment||||<0.001
70857213|NCT03718299|141200539|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Total Work Productivity Impairment||||<0.001
70945887|NCT00878553|141392796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74||||0.4835||95.0|||||ANOVA|2 degrees of freedom F-test||Half-Life (t1/2 in hours) of plasma zaleplon from each of 3 doses of SKP-1041||||0.4835
70945888|NCT00461123|141392797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.93||||0.5248||95.0|-4.18|8.05|||ANCOVA|Analysis of covariance (ANCOVA), baseline as covariate, treatment as fixed factor|Difference of least squares (LS) means (Placebo minus Vardenafil)|null hypothesis: mean of Vardenafil group equals mean of Placebo group at day +90||8.05|-4.18|0.5248
70945889|NCT00461123|141392798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.87||95.0|-3.58|3.04|||ANCOVA|Analysis of covariance (ANCOVA), baseline as covariate, treatment as fixed factor|Difference of LS means (Placebo minus Vardenafil)|null hypothesis: mean of Vardenafil group equals mean of Placebo group at day +90||3.04|-3.58|0.8700
70945890|NCT00461123|141392799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.57||||0.4162||95.0|-8.21|19.35|||ANCOVA|Analysis of covariance (ANCOVA), baseline as covariate, treatment as fixed factor|Difference of LS means (Placebo minus Vardenafil)|null hypothesis: mean of Vardenafil group equals mean of Placebo group at day +90||19.35|-8.21|0.4162
70857214|NCT03718299|141200540|SUPERIORITY||Mean|79.5|STANDARD_DEVIATION|20.06|||TWO_SIDED|||||||||Treatment Satisfaction Questionnaire for Medication over time- Effectiveness||||
70857215|NCT03718299|141200540|SUPERIORITY||||||<|0.001|||||||Exact binomial test|||Treatment Satisfaction Questionnaire for Medication over time-Side Effects||||<0.001
70857216|NCT03718299|141200540|SUPERIORITY||Mean|82.2|STANDARD_DEVIATION|16.35|||TWO_SIDED|||||||||Treatment Satisfaction Questionnaire for Medication over time - Convenience||||
70857217|NCT03718299|141200540|SUPERIORITY||Mean|81.9|STANDARD_DEVIATION|20.47|||TWO_SIDED|||||||||Treatment Satisfaction Questionnaire for Medication over time - Global Satisfaction||||
70857218|NCT03718299|141200541|SUPERIORITY||Mean|8.7|STANDARD_DEVIATION|2.01|||TWO_SIDED|||||||||Improvement in Symptoms||||
70857219|NCT03718299|141200541|SUPERIORITY||Mean|8.3|STANDARD_DEVIATION|2.3|||TWO_SIDED|||||||||Speed of Symptom Improvement||||
70857220|NCT03718299|141200541|SUPERIORITY||Mean|9.1|STANDARD_DEVIATION|1.7|||TWO_SIDED|||||||||Frequency of Taking Medication||||
70857221|NCT03718299|141200541|SUPERIORITY||Mean|9.6|STANDARD_DEVIATION|0.68|||TWO_SIDED|||||||||Side Effects||||
70857222|NCT03718299|141200542|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70945891|NCT00461123|141392800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5||||0.0588||95.0|-13.25|0.26|||ANCOVA|Analysis of covariance (ANCOVA), baseline as covariate, treatment as fixed factor|Difference of LS means (Placebo minus Vardenafil)|null hypothesis: mean of Vardenafil group equals mean of Placebo group at day +90||0.26|-13.25|0.0588
70945892|NCT00461123|141392801|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.61||||0.7878||95.0|-22.03|16.82|||ANCOVA|Analysis of variance (ANOVA), treatment as fixed factor|Difference of LS means (Placebo minus Vardenafil)|null hypothesis: mean of Vardenafil group equals mean of Placebo group||16.82|-22.03|0.7878
70945893|NCT00702546|141392802|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-9.4|||||TWO_SIDED|95.0|-19.5|0.7||||||Treatment groups were compared with a generalized linear model for the cumulative ongoing pregnancy rate including covariates treatment group, age class (\< 32 yrs vs. ≥ 32 yrs), planned IVF treatment (IVF vs. ICSI) and region (Europe vs. Asia).||0.7|-19.5|
70857223|NCT01475071|141200567|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non inferiority margin of -10%|Mean Difference (Final Values)|-3.5|STANDARD_DEVIATION|15.6||0.0345|ONE_SIDED|95.0|-6.8||||paired Student's t statistic|||The primary purpose of this study is to demonstrate the non-inferiority of Metvix and daylight compared to Metvix and the lamp in terms of lesion complete response rate.|||-6.8|0.0345
70945894|NCT05896696|141392817|OTHER||Mean Difference (Final Values)|-1.87|||<|0.0001|TWO_SIDED|95.0|-2.49|-1.26|||Paired sample t-test|||||-1.26|-2.49|<0.0001
70945895|NCT05896696|141392818|OTHER||Mean Difference (Final Values)|-1.22|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.73|||paired sample t-test|||||-0.73|-1.70|<0.0001
70857224|NCT01475071|141200568|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9|STANDARD_DEVIATION|2.7|<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|two-sided Wilcoxon rank signed||superiority of Metvix adaylight and Metvix Lamp in term of pain||||<0.001
70857225|NCT05072470|141200582|SUPERIORITY|When p-value is adjusted for multiple comparisons, the level of statistical significance must be \</= to .01666667 (.05/3)|||||<|0.01|||||||t-test, 2 sided|||Speech intelligibility will be better with hearing aids plus Roger device, than with hearing aids alone when tested using standardized speech test at 0 dB SNR||||<0.01
70857226|NCT05072470|141200582|SUPERIORITY|||||||0.031||||||When p value is adjusted for multiple comparisons, the level of statistical significance must be \</= to .01666667 (.05/3)|t-test, 2 sided|||Speech intelligibility will be better with hearing aids plus Roger device, than with hearing aids alone when tested using standardized speech test at -5 dB SNR||||.031
70857227|NCT05072470|141200582|SUPERIORITY|||||||0.046||||||When p-values are adjusted for multiple comparisons, the level of statistical significance must be \</= .01666667 (.05/3)|t-test, 2 sided|||Speech intelligibility will be equal or better with hearing aids plus Roger device than with hearing aids alone when tested using standardized speech test at +5 dB SNR.||||.046
70857228|NCT02514473|141200585|SUPERIORITY||Least Square (LS) Mean Difference|-1.09|||<|0.0001|TWO_SIDED|95.0|-1.43|-0.75|||MMRM|||Analysis was performed using mixed-effects model for repeated measures (MMRM). The model included treatment, visit and treatment-by-visit interaction as fixed effects; and participant as a random effect with adjustments for baseline, weight (less than \[\<\] 25 kilogram \[kg\] versus greater than or equal to \[\>=\] 25 kg) and percent predicted forced expiratory volume in 1 second (FEV1) severity (\<90 versus \>=90) at screening.||-0.75|-1.43|< 0.0001
70857229|NCT01607203|141200606|NON_INFERIORITY_OR_EQUIVALENCE|t -test||||||0.04|TWO_SIDED||||||Fisher Exact|||||||0.04
70857230|NCT00609362|141200623|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||P-value is un-adjusted. A priori threshold for significance: 0.05|t-test, 2 sided|||The minimum number of participants was determined by power calculations to be 44 (22 in each group), assuming a difference in change in BMD of 1.7%, a standard deviation of 2%, a power of 80%, and a level of significance of 5%.||||0.055
70857231|NCT00609362|141200624|SUPERIORITY_OR_OTHER|||||||0.056||95.0|||||t-test, 2 sided|||||||0.056
70857232|NCT00609362|141200625|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
70857233|NCT00548405|141200634|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.0084|TWO_SIDED|95.0|0.38|0.87||Hochberg method was used to adjust for the two co-primary outcomes.|Cox Proportional Hazards Regression|||Cox proportional hazards (PH) regression model with robust variance estimation using treatment group and geographic region as covariate was used.||0.87|0.38|0.0084
70945896|NCT02080403|141392827|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.1159|TWO_SIDED|95.0|-0.4|0.04|||Mixed Models Analysis|||||0.04|-0.40|0.1159
70945897|NCT02330276|141392872|SUPERIORITY_OR_OTHER|||||||0.05||||||The reported P-Value was calculated|General linear mixed-effects models|||||||0.05
70945898|NCT02330276|141392873|OTHER|one way ANOVA between groups|Mean Difference (Final Values)|77.9|STANDARD_DEVIATION|11.9|<|0.05|TWO_SIDED|95.0|70.3|85.5||for change in heart rate at 24 hr post-dosing from baseline between the 3 doses|ANOVA|||Primary hypothesis: None of the doses of (+)-epicatechin will differ with regard to change from baseline in any of the major safety endpoints; heart rate, systolic and diastolic blood pressure.||85.5|70.3|<0.05
70945899|NCT02330276|141392874|SUPERIORITY_OR_OTHER|||||||0.05||||||The reported P-Value was calculated|General linear mixed-effects models|||||||0.05
70945900|NCT02330276|141392875|SUPERIORITY_OR_OTHER|||||||0.05||||||The reported P-Value was calculated|General linear mixed-effects models|||||||0.05
70945901|NCT02330276|141392876|SUPERIORITY_OR_OTHER|||||||0.05||||||The reported P-Value was calculated|General linear mixed-effects models|||||||0.05
70857234|NCT00548405|141200635|SUPERIORITY_OR_OTHER||Rate ratio|0.51|||<|0.0001|TWO_SIDED|95.0|0.39|0.65||Hochberg method was used to adjust for the two co-primary outcomes.|Proportional means regression|||Proportional means regression model with robust variance estimation and covariate adjustment for geographic region was used.||0.65|0.39|<0.0001
70857235|NCT00548405|141200636|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.41|0.69|||Cox Proportional Hazards Regression|||Cox PH regression model with robust variance estimation and covariate adjustment for geographic region was used.||0.69|0.41|<0.0001
70857236|NCT00548405|141200637|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wei-Lachin|||The analysis was performed using Wei-Lachin method for non-parametric analysis of repeated measures.||||<0.0001
70945902|NCT04702893|141392885|OTHER|No formal hypotheses were tested.||||||0.1185|||||||Z-test of correlation|||||||0.1185
70945903|NCT04702893|141392886|OTHER|No formal hypotheses were tested.||||||0.5135|||||||Z-test of correlation|||||||0.5135
70857237|NCT00548405|141200638|SUPERIORITY_OR_OTHER|||||||0.0022|||||||Wei-Lachin|||Change at Year 2: the analysis was performed using Wei-Lachin method for non-parametric analysis of repeated measures.||||0.0022
70857238|NCT00548405|141200639|SUPERIORITY_OR_OTHER|||||||0.1371|TWO_SIDED||||||Ranked ANCOVA|||Ranked ANCOVA models with covariate adjustment for geographic region and Baseline T2 lesion volume was used.||||0.1371
70857239|NCT02582684|141200640|OTHER|Binomial Proportion of Participants with Virologic Success and 95% Confidence Interval|proportion|0.9|||||TWO_SIDED|95.0|0.83|0.95|||||Confidence interval was calculated using the Clopper-Pearson exact method.|||0.95|0.83|
70945904|NCT04702893|141392887|OTHER|No formal hypotheses were tested.||||||0.0764|||||||Z-test of correlation|||||||0.0764
70945905|NCT04702893|141392888|OTHER|No formal hypotheses were tested.||||||0.3478|||||||Z-test of correlation|||||||0.3478
70945906|NCT04469465|141392891|SUPERIORITY|||||||0.0007|||||||Re-randomization Test|||Interim Efficacy Analysis||||0.0007
70945907|NCT04469465|141392891|SUPERIORITY|||||||0.0007|||||||Re-randomization Test|||Full Analysis||||0.0007
70945908|NCT04469465|141392891|SUPERIORITY||LS Mean Difference|24.44|STANDARD_ERROR_OF_MEAN|3.751|<|0.0001|TWO_SIDED|95.0|16.9|31.99|||Mixed Models Analysis|||Interim Efficacy Analysis||31.99|16.90|<0.0001
70945909|NCT04469465|141392891|SUPERIORITY||Difference|23.46|STANDARD_ERROR_OF_MEAN|3.585|<|0.0001|TWO_SIDED|95.0|16.31|30.61|||Mixed Models Analysis|||Full Analysis||30.61|16.31|<0.0001
70945910|NCT01660256|141392916|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
70945911|NCT01660256|141392917|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
70945912|NCT03491215|141392918|OTHER|Comparison|GMR|0.801|||||TWO_SIDED|90.0|0.49|1.311||||||Group 3 vs Group 2||1.311|0.490|
71125555|NCT00026312|141757695|SUPERIORITY_OR_OTHER_LEGACY||Log Rank Test Statistic|3.4471||||0.0634|TWO_SIDED|95.0|||||Log Rank|||The overall survival distributions of patients randomized to Regimen A - RA Only and randomized to Regimen B - RA + Immunotherapy were compared using the log-rank test.||||0.0634
71125556|NCT00026312|141757695|SUPERIORITY_OR_OTHER_LEGACY||Log-Rank Test Statistic|4.1362||||0.042|TWO_SIDED|95.0|||||Log Rank|||The overall survival distributions of patients randomized to Regimen A - RA Only and randomized to Regimen B - RA + Immunotherapy for the subgroup of patients with INSS Stage 4 disease were compared using the log-rank test.||||0.042
71125557|NCT01638546|141757708|OTHER||||||||||||||||||The study will be performed as a double-blind, placebo controlled, randomized Phase II in patients with relapsed sensitive or refractory SCLC. Eligible patients will be randomized 1:1 to one of two treatment arms: ABT-888 and temozolomide as the investigational arm, versus placebo and temozolomide as the control arm. The randomization will be stratified by center and by type or relapse (sensitive vs. refractory). The primary objective is to compare the two treatment regimens with respect to efficacy, expressed as Progression Free Survival (PFS) at 4 months post-randomization. PFS will be calculated as proportion of patients alive and without evidence of disease at 4 months after randomization.|||
71125558|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||60.66|TWO_SIDED|95.0|0.85|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.25|0.85|60.66
71125559|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.19||||95.21|TWO_SIDED|95.0|0.97|1.47||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.47|0.97|95.21
70945913|NCT03491215|141392918|OTHER|Comparison|GMR|0.991|||||TWO_SIDED|90.0|0.532|1.846||||||Group 3 vs. Group 1||1.846|0.532|
70945914|NCT03491215|141392918|OTHER|Comparison|GMR|1.237|||||TWO_SIDED|90.0|0.639|2.394||||||Group 2 vs. Group 1||2.394|0.639|
70945915|NCT03491215|141392919|OTHER|Comparison|GMR|0.709|||||TWO_SIDED|90.0|0.425|1.184||||||Group 3 vs. Group 2||1.184|0.425|
70945916|NCT03491215|141392919|OTHER|Comparison|GMR|0.968|||||TWO_SIDED|90.0|0.506|1.851||||||Group 3 vs. Group 1||1.851|0.506|
70945917|NCT03491215|141392919|OTHER|Comparison|GMR|1.365|||||TWO_SIDED|90.0|0.686|2.714||||||Group 2 vs. Group 1||2.714|0.686|
70945918|NCT03491215|141392921|OTHER|Comparison|GMR|0.759|||||TWO_SIDED|90.0|0.245|2.352||||||Group 3 vs. Group 2||2.352|0.245|
70945919|NCT03491215|141392921|OTHER|Comparison|GMR|0.516|||||TWO_SIDED|90.0|0.15|1.784||||||Group 3 vs. Group 1||1.784|0.150|
70945920|NCT03491215|141392921|OTHER|Comparison|GMR|0.681|||||TWO_SIDED|90.0|0.178|2.597||||||Group 2 vs. Group 1||2.597|0.178|
70945921|NCT03491215|141392929|SUPERIORITY||Odds Ratio (OR)|0.976|||||TWO_SIDED|95.0|0.858|1.109||||||||1.109|0.858|
70945922|NCT03491215|141392929|SUPERIORITY||Odds Ratio (OR)|0.951|||||TWO_SIDED|95.0|0.735|1.232||||||||1.232|0.735|
70945923|NCT03491215|141392930|SUPERIORITY||Hazard Ratio (HR)|1.014|||||TWO_SIDED|95.0|0.921|1.115||||||||1.115|0.921|
70945924|NCT03491215|141392930|SUPERIORITY||Hazard Ratio (HR)|1.029|||||TWO_SIDED|95.0|0.841|1.258||||||||1.258|0.841|
70945925|NCT03491215|141392931|SUPERIORITY||Hazard Ratio (HR)|1.063|||||TWO_SIDED|95.0|1.012|1.117||||||||1.117|1.012|
70945926|NCT03491215|141392931|SUPERIORITY||Hazard Ratio (HR)|1.132|||||TWO_SIDED|95.0|1.025|1.25||||||||1.25|1.025|
70945927|NCT00551135|141392965|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0668|TWO_SIDED|||||Hochberg's adjustment applied to p-value; Hochberg's adjusted p-value was the primary analysis.|ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0668
70945928|NCT00551135|141392965|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0334|TWO_SIDED|||||Unadjusted (raw) p-value.|ANOVA|||LS (least squares) means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0334
70945929|NCT00551135|141392965|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8003|TWO_SIDED|||||Hochberg's adjustment applied to p-value; Hochberg's adjusted p-value was the primary analysis.|ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8003
70945930|NCT00551135|141392965|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8003|TWO_SIDED|||||Unadjusted (raw) p-value.|ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8003
70945931|NCT00551135|141392965|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6932|TWO_SIDED|||||Unadjusted (raw) p-value.|ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6932
70945932|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4471|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4471
70945933|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7248|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7248
70857240|NCT02582684|141200641|OTHER|Binomial Proportion of Participants with Virologic Success and 95% Confidence Interval|Proportion|0.89|||||TWO_SIDED|95.0|0.82|0.94|||||Confidence interval was calculated using the Clopper-Pearson exact method.|||0.94|0.82|
70857241|NCT02582684|141200642|OTHER|Binomial Proportion of Participants with Virologic Success and 95% Confidence Interval|proportion|0.85|||||TWO_SIDED|95.0|0.77|0.91|||||Confidence interval was calculated using the Clopper-Pearson exact method.|||0.91|0.77|
70857242|NCT01431300|141200661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|54.0|STANDARD_DEVIATION|12.0|<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||signal-to-noise (SNR) ratios of the central veins in the 0.01 mmol/kg and 0.03mmol/kg dose groups were compared.||||<0.01
70945934|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7556|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7556
70945935|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0571|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0571
70945936|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0197|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0197
70945937|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2398|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2398
70945938|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0709|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0709
70945939|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9902|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9902
70945940|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0018|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0018
70945941|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4639|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4639
70857243|NCT01431300|141200661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.0|STANDARD_DEVIATION|19.0|<|0.01||95.0|||||t-test, 2 sided|||contrast-to-noise (CNR) ratios of the central veins in the 0.01 mmol/kg and 0.03mmol/kg dose groups were compared.||||<0.01
70857244|NCT06054269|141200662|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.004
71125560|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||74.29|TWO_SIDED|95.0|0.88|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.28|0.88|74.29
71125561|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.29||||99.48|TWO_SIDED|95.0|1.06|1.58||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.58|1.06|99.48
71125562|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.87||||13.98|TWO_SIDED|95.0|0.66|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RML; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.66|13.98
71125563|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.28||||97.92|TWO_SIDED|95.0|1.01|1.62||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RML; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.62|1.01|97.92
71125564|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.14||||80.24|TWO_SIDED|95.0|0.84|1.54||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.54|0.84|80.24
71125565|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.3||||97.79|TWO_SIDED|95.0|1.01|1.66||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.66|1.01|97.79
71125566|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||51.27|TWO_SIDED|95.0|0.81|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.25|0.81|51.27
71125567|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.15||||90.66|TWO_SIDED|95.0|0.93|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.42|0.93|90.66
71125568|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||54.89|TWO_SIDED|95.0|0.9|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.12|0.90|54.89
71125569|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.1||||94.45|TWO_SIDED|95.0|0.98|1.24||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.24|0.98|94.45
70945942|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4845|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4845
70945943|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1641|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1641
70945944|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1025|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1025
70945945|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5615|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5615
70945946|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2904|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2904
71087766|NCT03074695|141682008|OTHER||Risk Difference (RD)|3.03||||0.766|TWO_SIDED|95.0|-14.02|20.08|||Regression, Logistic|Adjusted for baseline characteristics (parturient race, ethnicity, height, and induction status).||||20.08|-14.02|0.766
71087767|NCT01774981|141682018|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0449|||||||t-test, 1 sided|||||||0.0449
71087768|NCT01774981|141682018|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0808|||||||t-test, 1 sided|||||||0.0808
71087769|NCT01774981|141682018|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2219|||||||t-test, 1 sided|||||||0.2219
71087770|NCT01324102|141682031|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|95.0||||The a priori threshold for statistical significance is .05. The .004 value exceeds this value. There was only one comparison, so there was no adjustment for multiple comparison. This analysis refers to the row and category of anxiety.|ANOVA|F=10.25||Repeated measure Analysis of Variance (ANOVA) with null hypothesis of no group differences, comparing anxiety scores pre-Yoga versus post-Yoga, between the two groups for changes in anxiety.||||.004
71087771|NCT01324102|141682031|SUPERIORITY_OR_OTHER|||||||0.056|TWO_SIDED|||||F=4.07. The a priori threshold for statistical significance is .05. The .056 value does not exceed it. There was only one comparison, so there was no adjustment for multiple comparison. This analysis refers to the row/category of insomnia.|ANOVA|||Repeated measure Analysis of Variance (ANOVA) with null hypothesis of no group differences, comparing insomnia scores pre-Yoga versus post-Yoga, between the two groups. This measures changes in insomnia.||||.056
71087772|NCT00386334|141682034|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
71087773|NCT00386334|141682037|SUPERIORITY_OR_OTHER|||||||0.0014||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.0014
71087774|NCT00386334|141682040|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
71087775|NCT00386334|141682043|SUPERIORITY_OR_OTHER|||||||0.0005||||||Multiple comparisons not applied due to only two treatments in study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.0005
71087776|NCT00386334|141682046|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
71087777|NCT00386334|141682049|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
71087778|NCT00386334|141682052|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
71087779|NCT00386334|141682055|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
71087780|NCT00386334|141682058|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
71087781|NCT00386334|141682061|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
71087782|NCT00386334|141682064|SUPERIORITY_OR_OTHER|||||||0.1175||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.1175
71087783|NCT00386334|141682067|SUPERIORITY_OR_OTHER|||||||0.0717||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.0717
71087784|NCT00386334|141682070|SUPERIORITY_OR_OTHER|||||||0.1182||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|||||||0.1182
71087785|NCT00386334|141682073|SUPERIORITY_OR_OTHER|||||||0.301||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.3010
71087786|NCT00386334|141682076|SUPERIORITY_OR_OTHER|||||||0.78||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.7800
71087787|NCT00386334|141682079|SUPERIORITY_OR_OTHER|||||||0.0803||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.0803
70945947|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6017|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6017
71125570|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.09||||94.09|TWO_SIDED|95.0|0.98|1.21||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.21|0.98|94.09
71125571|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||62.95|TWO_SIDED|95.0|0.91|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.91|62.95
71125572|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.12||||96.86|TWO_SIDED|95.0|0.99|1.26||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.26|0.99|96.86
71125573|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.09||||94.16|TWO_SIDED|95.0|0.98|1.2||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.20|0.98|94.16
71125574|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||48.99|TWO_SIDED|95.0|0.86|1.15||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.15|0.86|48.99
71125575|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.12||||94.51|TWO_SIDED|95.0|0.98|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.28|0.98|94.51
71125576|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.13||||94.59|TWO_SIDED|95.0|0.97|1.31||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.31|0.97|94.59
71125577|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||61.27|TWO_SIDED|95.0|0.86|1.23||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.23|0.86|61.27
71125578|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.15||||96.63|TWO_SIDED|95.0|0.99|1.34||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.No|FRC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.34|0.99|96.63
71125579|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.12||||94.02|TWO_SIDED|95.0|0.97|1.29||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.29|0.97|94.02
70945948|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8549|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8549
71087788|NCT00386334|141682082|SUPERIORITY_OR_OTHER|||||||0.2643||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.2643
71087789|NCT00386334|141682085|SUPERIORITY_OR_OTHER|||||||0.0765||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.0765
71087790|NCT00386334|141682088|SUPERIORITY_OR_OTHER|||||||0.2967||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.2967
71087791|NCT00386334|141682091|SUPERIORITY_OR_OTHER|||||||0.0634||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.0634
70945949|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3386|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3386
71087792|NCT00386334|141682094|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
71087793|NCT00902577|141682103|OTHER||Hazard Ratio (HR)|1.54||||0.048|TWO_SIDED|95.0|1.0|2.36|||Regression, Cox|||"FMISO selectively binds to hypoxic tissues so that SUVpeak within a region provides a measure of tumor hypoxia.:~This marker was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||2.36|1.0|0.048
71087794|NCT00902577|141682103|OTHER||Hazard Ratio (HR)|1.16||||0.5|TWO_SIDED|95.0|0.75|1.81|||Regression, Cox|||T/Bmax is the pixel in the tumor region with the maximum tumor:blood ratio (T/Bmax) and T/Bmax depicts the magnitude of the hypoxia TBmax was modeled with a univariate Cox regression model for OS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported. The study was designed to enroll 46 evaluable participants to detect a log hazard ratio of 1.279 for TBmax with HV as a covariate with a 50% event rate||1.81|.75|0.50
71087795|NCT00902577|141682103|OTHER||Hazard Ratio (HR)|1.0||||0.9|TWO_SIDED|0.97|0.97|1.03|||Regression, Cox|||"Hypoxia Volume (HV) depicts the volume of tumor that has crossed the threshold for hypoxia.~Hypoxic Volume (HV) was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.03|0.97|0.90
71087796|NCT00902577|141682103|OTHER||Hazard Ratio (HR)|1.17||||0.024|TWO_SIDED|95.0|1.02|1.34|||Regression, Cox||HR reported per 0.01 increase|"ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Mean ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model Mean ktrans was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.34|1.02|0.024
71087797|NCT00902577|141682103|OTHER||Hazard Ratio (HR)|1.32||||0.045|TWO_SIDED|95.0|1.01|1.72|||Regression, Cox||HR reported per 0.01 increase|"ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Median ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.~Median ktrans was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.72|1.01|0.045
71087798|NCT00902577|141682103|OTHER||Hazard Ratio (HR)|1.11||||0.31|TWO_SIDED|95.0|0.9|1.37|||Regression, Cox|||Relative cerebral blood volume (RCBV) maps, computed from the integral of ∆R2\*(t), were corrected for leakage effects and normalized to normal appearing white matter (nRCBV); nRCBV provides a measure of tumor vasculature and was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.||1.37|0.90|0.31
71087799|NCT00902577|141682103|OTHER||Hazard Ratio (HR)|1.07||||0.51|TWO_SIDED|95.0|0.88|1.29|||Regression, Cox|||cerebral blood flow (CBF) maps were was normalized to the mean of the region of interest (ROI) in normal appearing white matter to produce the nCBF and provide another measure of vascular permeability and perfusion nCBF was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.||1.29|0.88|0.51
71087800|NCT00902577|141682103|OTHER||Hazard Ratio (HR)|1.0||||0.97|TWO_SIDED|95.0|0.79|1.26|||Regression, Cox|||Apparent Diffusion Coefficient (ADC) measures water diffusion through tissue. Cerebral infarction leads to diffusion restriction resulting in a low ADC signal in the infarcted area. A double Gaussian mixed model was fit to the ADC histogram and the mean of the lower ADC curve, was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.||1.26|0.79|0.9700
71087801|NCT00902577|141682103|OTHER||Hazard Ratio (HR)|0.99||||0.9007|TWO_SIDED|95.0|0.91|1.09|||Regression, Cox|||Apparent Diffusion Coefficient (ADC) measures water diffusion through tissue. Cerebral infarction leads to diffusion restriction resulting in a low ADC signal in the infarcted area. A double Gaussian mixed model was fit to the ADC histogram and the mean of the higher ADC curve, was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.||1.09|0.91|0.9007
70945950|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.707|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7070
70945951|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5244|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5244
70945952|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4245|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4245
70945953|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8624|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8624
70945954|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7552|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7552
71087802|NCT00902577|141682104|OTHER||Hazard Ratio (HR)|1.24||||0.33|TWO_SIDED|95.0|0.8|1.91|||Regression, Cox|||"FMISO selectively binds to hypoxic tissues so that SUVpeak within a region provides a measure of tumor hypoxia.~This marker was modeled with a univariate Cox regression model for Progression Free Survival time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.91|.80|0.33
71087803|NCT00902577|141682104|OTHER||Hazard Ratio (HR)|0.93||||0.72|TWO_SIDED|95.0|0.61|1.4|||Regression, Cox|||T/Bmax is the pixel in the tumor region with the maximum tumor:blood ratio (T/Bmax) and T/Bmax depicts the magnitude of the hypoxia TBmax was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.||1.4|.61|0.72
71087804|NCT00902577|141682104|OTHER||Hazard Ratio (HR)|1.01||||0.355|TWO_SIDED|95.0|0.98|1.04|||Regression, Cox|||"Hypoxia Volume (HV) depicts the volume of tumor that has crossed the threshold for hypoxia.~Hypoxic Volume (HV) was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.04|.98|0.355
71087805|NCT00902577|141682104|OTHER||Hazard Ratio (HR)|1.1||||0.074|TWO_SIDED|95.0|0.99|1.23|||Regression, Cox|||"ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Mean ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.~Mean ktrans was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.23|0.99|0.074
71087806|NCT00902577|141682104|OTHER||Hazard Ratio (HR)|1.3||||0.021|TWO_SIDED|95.0|1.04|1.63|||Regression, Cox|||"ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Median ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.~Median ktrans was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.63|1.04|0.021
70945955|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7329|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7329
70945956|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3053|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3053
70945957|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.529|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5290
70945958|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7951|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7951
70945959|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.715|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7150
70945960|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4566|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4566
70945961|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.775|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7750
70945962|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9241|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9241
70945963|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8994|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8994
71087807|NCT00902577|141682104|OTHER||Hazard Ratio (HR)|1.28||||0.0096|TWO_SIDED|95.0|1.06|1.54|||Regression, Cox|||"Relative cerebral blood volume (RCBV) maps, computed from the integral of ∆R2\*(t), were corrected for leakage effects and normalized to normal appearing white matter (nRCBV); nRCBV provides a measure of tumor vasculature and was modeled with a univariate Cox regression model for PFS time.~The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.54|1.06|0.0096
70945964|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2088|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2088
70945965|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2152|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2152
70857245|NCT06054269|141200662|SUPERIORITY|||||||0.066|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.066
71087808|NCT00902577|141682104|OTHER||Hazard Ratio (HR)|1.18||||0.038|TWO_SIDED|95.0|1.01|1.38|||Regression, Cox|||"cerebral blood flow (CBF) maps were was normalized to the mean of the region of interest (ROI) in normal appearing white matter to produce the nCBF and provide another measure of vascular permeability and perfusion.~nCBF was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.38|1.01|0.038
71087809|NCT00902577|141682104|OTHER||Odds Ratio (OR)|0.682||||0.3253|TWO_SIDED|95.0|0.318|1.463|||Regression, Logistic|||Logistic regression for SUVpeak to predict PFS6||1.463|0.318|0.3253
70857246|NCT06054269|141200662|SUPERIORITY|||||||0.694|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.694
70857247|NCT06054269|141200662|SUPERIORITY|||||||0.408|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.408
70857248|NCT06054269|141200663|SUPERIORITY|||||||0.164|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.164
71087810|NCT00902577|141682104|OTHER||Odds Ratio (OR)|0.991||||0.9836|TWO_SIDED|95.0|0.403|2.434|||Regression, Logistic|||TBmax was modeled with a univariate logistic regression model for PFS6.||2.434|0.403|0.9836
71087811|NCT00902577|141682104|OTHER||Odds Ratio (OR)|0.957||||0.1566|TWO_SIDED|95.0|0.9|1.017|||Regression, Logistic|||Hypoxic Volume (HV) was modeled with a logistic regression model for 6month progression free survival (PFS6) .||1.017|0.900|0.1566
71087812|NCT00902577|141682104|OTHER||Odds Ratio (OR)|0.993||||0.9554|TWO_SIDED|95.0|0.775|1.273|||Regression, Logistic|||"Mean ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.~Mean ktrans was modeled with a univariate logistic regression model for PFS6."||1.273|0.775|0.9554
71087813|NCT00902577|141682104|OTHER||Odds Ratio (OR)|0.919||||0.6941|TWO_SIDED|95.0|0.602|1.402|||Regression, Logistic|||"Median ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.~Median ktrans was modeled with a univariate logistic regression model for PFS6"||1.402|0.602|0.6941
71087814|NCT00902577|141682104|OTHER||Odds Ratio (OR)|0.744||||0.134|TWO_SIDED|95.0|0.506|1.095|||Regression, Logistic|||"Relative cerebral blood volume (RCBV) maps were corrected for leakage effects and normalized to normal appearing white matter (nRCBV).~nRCBV was modeled with a univariate logistic regression model for PFS6."||1.095|0.506|0.1340
71087815|NCT00902577|141682104|OTHER||Odds Ratio (OR)|0.821||||0.2642|TWO_SIDED|95.0|0.58|1.161|||Regression, Logistic|||"cerebral blood flow (CBF) maps were was normalized to the mean of the region of interest (ROI) in normal appearing white matter to produce the nCBF.~nCBF was modeled with a univariate logistic regression model for PFS6."||1.161|0.580|0.2642
71087816|NCT00902577|141682104|OTHER||Odds Ratio (OR)|0.855||||0.5069|TWO_SIDED|95.0|0.539|1.357|||Regression, Logistic|||Apparent Diffusion Coefficient (ADC) low values were modeled with a univariate logistic regression model for PFS6||1.357|0.539|0.5069
71087817|NCT00902577|141682104|OTHER||Odds Ratio (OR)|0.884||||0.1921|TWO_SIDED|95.0|0.735|1.064|||Regression, Logistic|||Apparent Diffusion Coefficient (ADC) high values were modeled with a univariate Logistic regression model for PFS6||1.064|0.735|0.1921
71087818|NCT00902577|141682104|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.61|||||TWO_SIDED|95.0|0.42|0.79||||||"FMISO selectively binds to hypoxic tissues so that SUVpeak within a region provides a measure of tumor hypoxia.~Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9."||0.79|0.42|
71087819|NCT00902577|141682104|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.59|||||TWO_SIDED|95.0|0.39|0.78||||||"T/Bmax is the pixel in the tumor region with the maximum tumor:blood ratio (T/Bmax) and T/Bmax depicts the magnitude of the hypoxia.~Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9."||0.78|0.39|
71087820|NCT00902577|141682104|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.64|||||TWO_SIDED|95.0|0.46|0.83||||||"Hypoxia Volume (HV) depicts the volume of tumor that has crossed the threshold for hypoxia.~Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9."||0.83|0.46|
71087821|NCT00902577|141682104|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.62|||||TWO_SIDED|95.0|0.42|0.83||||||"mean ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of mean ktrans to predict PFS9."||0.83|0.42|
71087822|NCT00902577|141682104|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.64|||||TWO_SIDED|95.0|0.44|0.84||||||"Median ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of Median ktrans to predict PFS9."||0.84|0.44|
71087823|NCT00902577|141682104|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.72|||||TWO_SIDED|95.0|0.54|0.89||||||nRCBV provides a measure of tumor vasculature Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9.||0.89|0.54|
70857249|NCT06054269|141200663|SUPERIORITY|||||||0.113|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.113
70857250|NCT06054269|141200663|SUPERIORITY|||||||0.404|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.404
70857251|NCT06054269|141200663|SUPERIORITY|||||||0.879|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.879
70945966|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7662|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7662
71087824|NCT00902577|141682104|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.72|||||TWO_SIDED|95.0|0.55|0.89||||||nCBF provides a measure of vascular permeability and perfusion. Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9.||0.89|0.55|
71087825|NCT00501631|141682133|SUPERIORITY_OR_OTHER|||||||0.336||95.0|||||Van der Waerden test|||The null hypothesis that there is no difference between two treatment groups (i.e. Placebo and Vivitrol) was tested using a two-sided Van der Waerden test. Response profiles were tabulated as a cumulative percent of subjects at each decile of percent heavy drinking days.||||0.336
71087826|NCT01249131|141682135|SUPERIORITY_OR_OTHER||Ratio of Least Squares (LS) Means (in %)|94.7|||||TWO_SIDED|90.0|83.9|107.0|||||LS mean was calculated from analysis of variance (ANOVA). Data for dose-normalized AUCinf were natural log-transformed prior to analysis. Ratio of AUCinf LS means for log-transformed parameter (expressed as a percent).|||107|83.9|
71087827|NCT01249131|141682135|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|110.0|||||TWO_SIDED|90.0|98.2|124.0|||||LS mean was calculated from ANOVA. Data for dose-normalized AUCinf were natural log-transformed prior to analysis. Ratio of AUCinf LS means for log-transformed parameter (expressed as a percent).|||124|98.2|
71087828|NCT01249131|141682136|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|96.9|||||TWO_SIDED|90.0|84.2|111.0|||||LS mean was calculated from ANOVA. Data for dose-normalized Cmax were natural log-transformed prior to analysis. Ratio of Cmax LS means for log-transformed parameter (expressed as a percent).|||111|84.2|
71087829|NCT01249131|141682136|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|107.0|||||TWO_SIDED|90.0|93.8|123.0|||||LS mean was calculated from ANOVA. Data for dose-normalized Cmax were natural log-transformed prior to analysis. Ratio of Cmax LS means for log-transformed parameter (expressed as a percent).|||123|93.8|
71087830|NCT04456686|141682142|SUPERIORITY||Posterior Mean Difference|-0.03|||||TWO_SIDED|95.0|-0.77|0.7|||Bayesian Mixed Model Analysis|||||0.70|-0.77|
70945967|NCT00551135|141392966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7579|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7579
71087831|NCT04456686|141682143|SUPERIORITY||Posterior Mean Difference|0.58|||||TWO_SIDED|95.0|-0.82|1.96|||Bayesian Mixed Model Analysis|||||1.96|-0.82|
71087832|NCT04456686|141682144|SUPERIORITY||Posterior Mean Difference|0.1|||||TWO_SIDED|95.0|-0.45|0.63|||Bayesian Mixed Model Analysis|||||0.63|-0.45|
71087833|NCT04456686|141682145|SUPERIORITY||Posterior Mean Difference|0.9|||||TWO_SIDED|95.0|-3.31|5.06|||Bayesian Mixed Model Analysis|||||5.06|-3.31|
71087834|NCT04456686|141682146|SUPERIORITY||Posterior Mean Difference|0.03|||||TWO_SIDED|95.0|-0.46|0.5|||Bayesian Mixed Model Analysis|||||0.50|-0.46|
71125580|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||53.24|TWO_SIDED|95.0|0.87|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.87|53.24
71087835|NCT04456686|141682147|SUPERIORITY||Posterior Mean Difference|0.11|||||TWO_SIDED|95.0|-0.72|0.91|||Bayesian Mixed Model Analysis|||||0.91|-0.72|
71087836|NCT04456686|141682148|SUPERIORITY||Posterior Mean Difference|2.45|||||TWO_SIDED|95.0|-7.27|12.2|||Bayesian Mixed Model Analysis|||||12.20|-7.27|
71087837|NCT04456686|141682149|SUPERIORITY||Posterior Mean Difference|0.4|||||TWO_SIDED|95.0|-0.04|0.85|||Bayesian Mixed Model Analysis|||||0.85|-0.04|
71087838|NCT04456686|141682150|SUPERIORITY||Posterior Mean Difference|168.61|||||TWO_SIDED|95.0|-38.22|379.2|||Bayesian Mixed Model Analysis|||||379.20|-38.22|
71087839|NCT04456686|141682151|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.07|0.06|||Bayesian Mixed Model Analysis|||||0.06|-0.07|
71087840|NCT01329198|141682155|SUPERIORITY||Mean Difference (Final Values)|-17.8|STANDARD_DEVIATION|9.4||0.013|TWO_SIDED||||||ANOVA||Mean change in YGTSS scores from Baseline to 6 Months across all study participants presented.|||||0.013
71087841|NCT00473083|141682157|SUPERIORITY_OR_OTHER|||||||0.8769||||||P for arm 1 v arms 2 and 3 combined|Chi-squared|||||||0.8769
71087842|NCT00473083|141682157|SUPERIORITY_OR_OTHER|||||||0.147||||||P for arm 1 v arms 2 and 3 combined|Wilcoxon (Mann-Whitney)|||||||0.147
71087843|NCT00473083|141682158|SUPERIORITY_OR_OTHER|||||||0.1503||||||P(arm 1 v arm 2) in patients with maximum severity of rash grade 1, 2a, or 2b|Wilcoxon (Mann-Whitney)|||||||0.1503
71087844|NCT00473083|141682158|SUPERIORITY_OR_OTHER|||||||0.4681||||||P(arm2 v arm3) in patients with maximum severity of rash grade 1, 2a, or 2b|Wilcoxon (Mann-Whitney)|||||||0.4681
71087845|NCT00473083|141682158|SUPERIORITY_OR_OTHER|||||||0.0196||||||P(arm 1 v arm 3) in patients with maximum severity of rash grade 1, 2a, or 2b|Wilcoxon (Mann-Whitney)|||||||0.0196
71087846|NCT00473083|141682158|SUPERIORITY_OR_OTHER|||||||0.1658||||||P(arm 1 v arm 2) in patients with maximum severity of rash grade 3|Wilcoxon (Mann-Whitney)|||||||0.1658
71087847|NCT00473083|141682158|SUPERIORITY_OR_OTHER||||||>|0.9999||||||"P(arm 2 v arm 3) in patients with maximum severity of rash grade 3.~P-value was calculated to be \>0.9999 using the Wilcoxon Rank Sumtest by comparing between the two treatment arms."|Wilcoxon (Mann-Whitney)|||||||>0.9999
71087848|NCT00473083|141682158|SUPERIORITY_OR_OTHER|||||||0.285||||||P(arm 1 v arm 3) in patients with maximum severity of rash grade 3|Wilcoxon (Mann-Whitney)|||||||0.285
71087849|NCT00473083|141682159|SUPERIORITY_OR_OTHER|||||||0.5097|||||||Chi-squared|||Maximal Rash Grade 1||||0.5097
71087850|NCT00473083|141682159|SUPERIORITY_OR_OTHER|||||||0.474|||||||Chi-squared|||Maximal Rash Grade 2a||||0.4740
71087851|NCT00473083|141682159|SUPERIORITY_OR_OTHER|||||||0.2123|||||||Chi-squared|||Maximal Severity Grade 2b||||0.2123
71087852|NCT00473083|141682159|SUPERIORITY_OR_OTHER|||||||0.5004|||||||Chi-squared|||Maximal Severity Grade 3||||0.5004
71087853|NCT00473083|141682159|SUPERIORITY_OR_OTHER|||||||0.9072|||||||Chi-squared|||Maximal Severity Grade 1||||0.9072
70857252|NCT06054269|141200664|SUPERIORITY||||||<|0.001|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||<0.001
70857253|NCT06054269|141200664|SUPERIORITY|||||||0.002|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.002
70857254|NCT06054269|141200664|SUPERIORITY|||||||0.468|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.468
70945968|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6896|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6896
70857255|NCT06054269|141200664|SUPERIORITY|||||||0.057|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.057
70857256|NCT06054269|141200665|SUPERIORITY|||||||0.112|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.112
70857257|NCT06054269|141200665|SUPERIORITY|||||||0.149|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.149
70857258|NCT06054269|141200665|SUPERIORITY|||||||0.101|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.101
71125581|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||70.84|TWO_SIDED|95.0|0.91|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.91|70.84
71125582|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||74.15|TWO_SIDED|95.0|0.92|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.92|74.15
71125583|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||65.43|TWO_SIDED|95.0|0.87|1.24||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal;Region; Upper; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.24|0.87|65.43
71125584|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.19||||97.15|TWO_SIDED|95.0|0.99|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Upper; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.42|0.99|97.15
71125585|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||63.99|TWO_SIDED|95.0|0.81|1.34||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Lower; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.34|0.81|63.99
71125586|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.15||||91.99|TWO_SIDED|95.0|0.94|1.41||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Lower; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.41|0.94|91.99
71125587|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||76.81|TWO_SIDED|95.0|0.94|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region;Central; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.94|76.81
71125588|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||67.01|TWO_SIDED|95.0|0.95|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal;Region; Central; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.09|0.95|67.01
71125589|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||63.91|TWO_SIDED|95.0|0.85|1.27||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Distal; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.27|0.85|63.91
71087854|NCT00473083|141682159|SUPERIORITY_OR_OTHER|||||||0.0464|||||||Chi-squared|||Maximal Severity Grade 2a||||0.0464
71087855|NCT00473083|141682159|SUPERIORITY_OR_OTHER|||||||0.6759|||||||Chi-squared|||Maximal Severity Grade 2b||||0.6759
71087856|NCT00473083|141682159|SUPERIORITY_OR_OTHER|||||||0.0065|||||||Chi-squared|||Maximal Severity Grade 3||||0.0065
71087857|NCT00473083|141682159|SUPERIORITY_OR_OTHER|||||||0.5898|||||||Chi-squared|||Maximal Severity Grade 1||||0.5898
71087858|NCT00473083|141682159|SUPERIORITY_OR_OTHER|||||||0.1921|||||||Chi-squared|||Maximal Severity Grade 2a||||0.1921
70857259|NCT06054269|141200665|SUPERIORITY|||||||0.259|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.259
71087859|NCT00473083|141682159|SUPERIORITY_OR_OTHER|||||||0.0882|||||||Chi-squared|||Maximal Severity Grade 2b||||0.0882
71087860|NCT00473083|141682159|SUPERIORITY_OR_OTHER|||||||0.0344|||||||Chi-squared|||Maximal Severity Grade 3||||0.0344
71087861|NCT00473083|141682160|SUPERIORITY_OR_OTHER|||||||0.3834|||||||Log Rank|||||||0.3834
71087862|NCT00473083|141682162|SUPERIORITY_OR_OTHER|||||||0.0147|||||||Wilcoxon (Mann-Whitney)|||||||0.0147
71087863|NCT02915835|141682164|SUPERIORITY|||||||0.7|||||||ANCOVA|||||||0.70
71087864|NCT02915835|141682165|SUPERIORITY|||||||0.61|||||||Fisher Exact|||||||0.61
71087865|NCT02915835|141682166|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71087866|NCT02915835|141682167|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71087867|NCT02915835|141682168|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71087868|NCT02915835|141682169|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71087869|NCT02915835|141682170|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
70857260|NCT06054269|141200666|SUPERIORITY|||||||0.097|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.097
71087870|NCT02915835|141682171|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71087871|NCT02915835|141682172|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71087872|NCT02915835|141682173|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71087873|NCT02915835|141682174|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71087874|NCT02915835|141682175|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71087875|NCT02915835|141682176|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71087876|NCT02915835|141682177|SUPERIORITY|||||||0.56|||||||Log Rank|||||||.56
71087877|NCT02915835|141682178|SUPERIORITY|||||||0.35|||||||Log Rank|||||||.35
71087878|NCT02915835|141682180|SUPERIORITY|||||||0.76|||||||ANCOVA|||||||.76
71087879|NCT02915835|141682181|SUPERIORITY|||||||0.57|||||||ANCOVA|||||||.57
71087880|NCT02915835|141682182|SUPERIORITY|||||||0.4|||||||ANCOVA|||||||.40
71087881|NCT02915835|141682183|SUPERIORITY|||||||0.49|||||||ANCOVA|||||||.49
71087882|NCT02915835|141682184|SUPERIORITY|||||||0.75|||||||ANCOVA|||||||.75
71087883|NCT02915835|141682185|SUPERIORITY|||||||0.41|||||||ANCOVA|||||||.41
71087884|NCT02915835|141682186|SUPERIORITY|||||||0.31|||||||ANCOVA|||||||0.31
71087885|NCT02915835|141682187|SUPERIORITY|||||||0.84|||||||ANCOVA|||||||0.84
71087886|NCT02915835|141682188|SUPERIORITY|||||||0.11|||||||ANCOVA|||||||0.11
71087887|NCT02915835|141682189|SUPERIORITY|||||||0.66|||||||ANCOVA|||||||0.66
71087888|NCT02915835|141682190|SUPERIORITY|||||||0.27|||||||ANCOVA|||||||0.27
71087889|NCT02915835|141682191|SUPERIORITY|||||||0.54|||||||ANCOVA|||||||0.54
71087890|NCT02915835|141682192|SUPERIORITY|||||||0.9|||||||ANCOVA|||||||.90
71087891|NCT02915835|141682193|SUPERIORITY|||||||0.68|||||||ANCOVA|||||||.68
71087892|NCT02915835|141682194|SUPERIORITY|||||||0.25|||||||ANCOVA|||||||.25
71087893|NCT02915835|141682195|SUPERIORITY|||||||0.95|||||||ANCOVA|||||||.95
71087894|NCT02915835|141682196|SUPERIORITY|||||||0.38|||||||ANCOVA|||||||0.38
71087895|NCT02915835|141682197|SUPERIORITY|||||||0.82|||||||ANCOVA|||||||.82
71087896|NCT02915835|141682198|SUPERIORITY|||||||0.47|||||||ANCOVA|||||||.47
71087897|NCT02915835|141682199|SUPERIORITY|||||||0.35|||||||ANCOVA|||||||0.35
71087898|NCT02915835|141682200|SUPERIORITY|||||||0.84|||||||ANCOVA|||||||0.84
71087899|NCT02915835|141682201|SUPERIORITY|||||||0.55|||||||ANCOVA|||||||0.55
71087900|NCT02915835|141682203|SUPERIORITY|||||||0.34|||||||ANCOVA|||||||0.34
71087901|NCT02915835|141682204|SUPERIORITY|||||||0.36|||||||ANCOVA|||||||0.36
71087902|NCT02915835|141682205|SUPERIORITY|||||||0.04|||||||ANCOVA|||||||0.04
71087903|NCT02915835|141682206|SUPERIORITY|||||||0.32|||||||ANCOVA|||||||0.32
71087904|NCT02915835|141682207|SUPERIORITY|||||||0.14|||||||ANCOVA|||||||0.14
71087905|NCT02915835|141682208|SUPERIORITY|||||||0.41|||||||ANCOVA|||||||0.41
71087906|NCT02915835|141682209|SUPERIORITY|||||||0.85|||||||ANCOVA|||||||0.85
71087907|NCT02915835|141682210|SUPERIORITY|||||||0.85|||||||ANCOVA|||||||0.85
71087908|NCT02915835|141682211|SUPERIORITY|||||||0.75|||||||ANCOVA|||||||0.75
71087909|NCT02915835|141682212|SUPERIORITY|||||||0.95|||||||ANCOVA|||||||0.95
71087910|NCT02915835|141682213|SUPERIORITY|||||||0.31|||||||ANCOVA|||||||0.31
71087911|NCT02915835|141682214|SUPERIORITY|||||||0.14|||||||ANCOVA|||||||0.14
71087912|NCT02915835|141682215|SUPERIORITY|||||||0.32|||||||ANCOVA|||||||0.32
71087913|NCT02915835|141682216|SUPERIORITY|||||||0.47|||||||Fisher Exact|||||||0.47
71087914|NCT02915835|141682217|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71087915|NCT02915835|141682218|SUPERIORITY|||||||0.73|||||||ANCOVA|||||||0.73
71087916|NCT02915835|141682219|SUPERIORITY|||||||0.32|||||||ANCOVA|||||||0.32
71087917|NCT02915835|141682220|SUPERIORITY|||||||0.45|||||||ANCOVA|||||||0.45
71087918|NCT02915835|141682221|SUPERIORITY|||||||0.58|||||||ANCOVA|||||||0.58
71087919|NCT02915835|141682222|SUPERIORITY|||||||0.39|||||||ANCOVA|||||||0.39
71087920|NCT02915835|141682223|SUPERIORITY|||||||0.14|||||||ANCOVA|||||||0.14
71087921|NCT00113607|141682224|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.79||||0.019|TWO_SIDED|95.0|0.65|0.96|||Log Rank|||||0.96|0.65|0.0190
71087922|NCT00113607|141682225|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.86||||0.0835|TWO_SIDED|95.0|0.72|1.02|||Log Rank|||||1.02|0.72|0.0835
71087923|NCT00113607|141682226|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.646||||0.008|TWO_SIDED|95.0|1.144|2.367|||Fisher Exact|||||2.367|1.144|0.0080
70945969|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1934|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1934
70945970|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6034|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6034
70945971|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7992|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7992
70945972|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.477|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4770
70945973|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.873|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8730
70945974|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2000
70945975|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5059|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5059
70945976|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0348|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0348
71087924|NCT00113607|141682227|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.95||||0.8203|TWO_SIDED|95.0|0.62|1.46|||Log Rank|||||1.46|0.62|0.8203
71087925|NCT01418339|141682241|SUPERIORITY||Treatment Difference|-4.63|||=|0.0028|TWO_SIDED|95.0|-7.62|-1.63||P-value was derived from a repeated measures linear model with treatment, week, and treatment by week interaction as fixed categorical effects, the baseline value as a fixed covariate, and week as the time variable for repeated measures.|MMRM|||The statistical comparison was performed using MMRM model at a significance level of 0.05 (2-sided).||-1.63|-7.62|=0.0028
71087926|NCT01418339|141682242|SUPERIORITY||Treatment Difference|-0.52|||=|0.0124|TWO_SIDED|95.0|-0.93|-0.12||P-value was derived from a repeated measures linear model with treatment, week, and treatment by week interaction as fixed categorical effects, the baseline value as a fixed covariate, and week as the time variable for repeated measures.|MMRM|||The statistical comparison was performed using MMRM model at a significance level of 0.05 (2-sided).||-0.12|-0.93|=0.0124
71087927|NCT01418339|141682243|SUPERIORITY||Treatment Difference|-2.0|||=|0.5317|TWO_SIDED|95.0|-8.31|4.32||P-value was derived from a repeated measures linear model with treatment, week, and treatment by week interaction as fixed categorical effects, the baseline value as a fixed covariate, and week as the time variable for repeated measures.|MMRM|||The statistical comparison was performed using MMRM model at a significance level of 0.05 (2-sided).||4.32|-8.31|=0.5317
71125590|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.18||||96.47|TWO_SIDED|95.0|0.99|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Distal D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.42|0.99|96.47
70857261|NCT06054269|141200666|SUPERIORITY|||||||0.733|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.733
70945977|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3815|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3815
70945978|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4716|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4716
70945979|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1063|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1063
70945980|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3884|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3884
70945981|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3787|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3787
70945982|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2537|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2537
71087928|NCT03093181|141682311|SUPERIORITY||Least square (LS) mean difference|3.12||||0.0128|TWO_SIDED|95.0|0.68|5.56||From Analysis of covariance (ANCOVA) with treatment main effect, age stratum and baseline as covariates|ANCOVA||Difference is first named treatment (test product) minus second named treatment (negative control) such that a positive value favors the first named treatment (test product).|||5.56|0.68|0.0128
71087929|NCT03093181|141682311|SUPERIORITY||LS mean difference|1.51||||0.2262|TWO_SIDED|95.0|-0.95|3.96||From ANCOVA with treatment main effect, age stratum and baseline as covariates.|ANCOVA||Difference is first named treatment (test product) minus second named treatment (negative control) such that a positive value favors the first named treatment (test product).|||3.96|-0.95|0.2262
71087930|NCT03093181|141682313|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0243|TWO_SIDED|95.0|1.08|3.15|||Odds Ratio|||Analysis of Lay Person Assessment Polarised Image.||3.15|1.08|0.0243
71087931|NCT03093181|141682313|SUPERIORITY||Odds Ratio (OR)|1.04||||0.8931|TWO_SIDED|95.0|0.61|1.78|||Odds Ratio|||Analysis of Lay Person Assessment Polarised Image.||1.78|0.61|0.8931
71087932|NCT03093181|141682313|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0181|TWO_SIDED|95.0|1.12|3.25|||Odds Ratio|||Analysis of Lay Person Assessment Non-Polarised Image.||3.25|1.12|0.0181
70857262|NCT06054269|141200666|SUPERIORITY|||||||0.477|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.477
70857263|NCT06054269|141200666|SUPERIORITY|||||||0.312|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.312
71087933|NCT03093181|141682313|SUPERIORITY||Odds Ratio (OR)|0.94||||0.8319|TWO_SIDED|95.0|0.55|1.63|||Odds Ratio|||Analysis of Lay Person Assessment Non-Polarised Image.||1.63|0.55|0.8319
71087934|NCT03093181|141682314|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.0279|TWO_SIDED|95.0|0.02|0.28|||ANOVA|ANOVA= average rate over all raters including effects of treatment and age stratum.||Analysis of Lay Person Assessment Polarised Image.||0.28|0.02|0.0279
71087935|NCT03093181|141682314|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.8887|TWO_SIDED|95.0|-0.12|0.14|||ANOVA|ANOVA= average rate over all raters including effects of treatment and age stratum.||Analysis of Lay Person Assessment Polarised Image.||0.14|-0.12|0.8887
71125591|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||72.17|TWO_SIDED|95.0|0.93|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region;Total; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.93|72.17
71125592|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||74.38|TWO_SIDED|95.0|0.95|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Total; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.95|74.38
70857264|NCT06054269|141200667|SUPERIORITY|||||||0.22|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.220
71087936|NCT03093181|141682314|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.0224|TWO_SIDED|95.0|0.02|0.28|||ANOVA|ANOVA= average rate over all raters including effects of treatment and age stratum.||Analysis of Lay Person Assessment Non-Polarised Image.||0.28|0.02|0.0224
71087937|NCT03093181|141682314|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.8253|TWO_SIDED|95.0|-0.15|0.12|||ANOVA|ANOVA= average rate over all raters including effects of treatment and age stratum.||Analysis of Lay Person Assessment Non-Polarised Image.||0.12|-0.15|0.8253
71087938|NCT04210986|141682318|SUPERIORITY||Odds Ratio (OR)|0.99|||>|0.9|TWO_SIDED|95.0|0.25|4.02||No adjustment made for multiple comparisons.|Fisher Exact||Odds ratio is for fisetin group, relative to the placebo group.|Null hypothesis: no difference in proportion of participants experiencing any TEAE between Fisetin and Placebo groups.||4.02|0.25|>0.9
71087939|NCT04210986|141682319|SUPERIORITY||Contrast of LS Means|-3.5||||0.9728|TWO_SIDED|95.0|-10.6|3.6||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 14 ASSESSMENT Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||3.6|-10.6|0.9728
71087940|NCT04210986|141682319|SUPERIORITY||Contrast of LS Means|-2.5||||0.9728|TWO_SIDED|95.0|-7.8|2.8||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 45 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||2.8|-7.8|0.9728
71125593|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||53.85|TWO_SIDED|95.0|0.9|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.12|0.90|53.85
70857265|NCT06054269|141200667|SUPERIORITY|||||||0.003|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.003
71125594|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.1||||95.02|TWO_SIDED|95.0|0.98|1.23||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.23|0.98|95.02
71125595|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||92.27|TWO_SIDED|95.0|0.97|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.18|0.97|92.27
71125596|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||54.65|TWO_SIDED|95.0|0.88|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.88|54.65
71125597|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||87.93|TWO_SIDED|95.0|0.95|1.23||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.23|0.95|87.93
71125598|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||77.57|TWO_SIDED|95.0|0.92|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.92|77.57
71125599|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||77.07|TWO_SIDED|95.0|0.95|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.95|77.07
71125600|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||78.42|TWO_SIDED|95.0|0.96|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.10|0.96|78.42
71125601|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||44.15|TWO_SIDED|95.0|0.93|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.93|44.15
71125602|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||52.79|TWO_SIDED|95.0|0.89|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.89|52.79
71125603|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.1||||94.51|TWO_SIDED|95.0|0.98|1.24||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region; Distal; SCRD28 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.24|0.98|94.51
71125604|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||93.16|TWO_SIDED|95.0|0.98|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.98|93.16
70945983|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0952|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0952
70945984|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7725|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7725
70945985|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.066|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0660
70945986|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3657|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3657
71087941|NCT04210986|141682319|SUPERIORITY||Contrast of LS Means|-20.5||||0.0829|TWO_SIDED|95.0|-37.7|-3.3||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||-3.3|-37.7|0.0829
70945987|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7717|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7717
71125605|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||73.7|TWO_SIDED|95.0|0.95|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.95|73.70
71125606|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||81.04|TWO_SIDED|95.0|0.96|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.10|0.96|81.04
70945988|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5849|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5849
71087942|NCT04210986|141682319|SUPERIORITY||Contrast of LS Means|-0.5||||0.9728|TWO_SIDED|95.0||||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Contrast of LS Means|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||||0.9728
71087943|NCT04210986|141682320|SUPERIORITY||Contrast of LS Means|2.52|||>|0.99|TWO_SIDED|95.0|-49.4|54.5||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 14 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||54.5|-49.4|>0.99
71087944|NCT04210986|141682320|SUPERIORITY||Contrast of LS Means|11.0|||>|0.99|TWO_SIDED|95.0|-36.8|58.8||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 45 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||58.8|-36.8|>0.99
71087945|NCT04210986|141682320|SUPERIORITY||Contrast of LS Means|-40.3||||0.6594|TWO_SIDED|95.0|-97.6|17.1||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||17.1|-97.6|0.6594
71087946|NCT04210986|141682320|SUPERIORITY||Contrast of LS Means|-6.9|||>|0.99|TWO_SIDED|95.0|-45.5|31.7||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||31.7|-45.5|>0.99
70945989|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.958|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9580
70945990|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9884|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9884
71125607|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||52.58|TWO_SIDED|95.0|0.94|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.94|52.58
71125608|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||15.85|TWO_SIDED|95.0|0.86|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.86|15.85
71125609|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||48.69|TWO_SIDED|95.0|0.9|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.90|48.69
71125610|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||52.25|TWO_SIDED|95.0|0.9|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.90|52.25
71125611|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||66.48|TWO_SIDED|95.0|0.91|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.91|66.48
71125612|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.88||||9.12|TWO_SIDED|95.0|0.72|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RML; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.72|9.12
71125613|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||16.95|TWO_SIDED|95.0|0.78|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RML; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.09|0.78|16.95
71125614|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||0.89|TWO_SIDED|95.0|0.75|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.75|0.89
71125615|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||50.4|TWO_SIDED|95.0|0.86|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.86|50.40
70857266|NCT06054269|141200667|SUPERIORITY|||||||0.897|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.897
70857267|NCT06054269|141200667|SUPERIORITY|||||||0.931|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.931
70945991|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6743|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6743
70857268|NCT00899392|141200686|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Student's t test|t-test, 2 sided|||||||<0.0001
70857269|NCT00899392|141200687|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Mann Whitney Test-non parametric||||>0.05
70857270|NCT00899392|141200688|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|paired||||||>0.05
70857271|NCT00899392|141200689|SUPERIORITY_OR_OTHER|||||||0.0053||95.0|||||t-test, 2 sided|||||||0.0053
70857272|NCT02387476|141200750|NON_INFERIORITY|This analysis was planned to assume a non-inferiority (NI) margin of 5 units and a 1-sided alpha level of 2.5%. A 2-sided 95% confidence interval (CI) was also planned to be provided around the difference between treatments, where non-inferiority would also be demonstrated if the upper bound of the 95% CI is less than or equal to the NI margin of 5 units. In this scenario, the 2-sided 95% CI equates to testing the 1-sided non-inferiority hypothesis.|Mean Difference (Final Values)|0.6|STANDARD_DEVIATION|1.13|<|0.001|TWO_SIDED|95.0|-1.7|2.9||The p-value to test non-inferiority of FRESCA Mask compared with CPAP Mask (FRESCA-CPAP\<5 units) assumes a 1-sided test using a level of significance of 2.5% and NI margin of 5 units.|t-test, 1 sided||The mean AHI is rounded to a single decimal point in the text of the report (3.0 and 2.4, respectively), in order to be consistent with standard reporting of AHI.|This analysis was planned to assume a non-inferiority (NI) margin of 5 units and a 1-sided alpha level of 2.5%. A 2-sided 95% confidence interval (CI) was also planned to be provided around the difference between treatments, where non-inferiority would also be demonstrated if the upper bound of the 95% CI is less than or equal to the NI margin of 5 units. In this scenario, the 2-sided 95% CI equates to testing the 1-sided non-inferiority hypothesis.||2.9|-1.7|<0.001
70857273|NCT02387476|141200751|NON_INFERIORITY|This analysis was planned to assume a non-inferiority (NI) margin of 5 units and a 1-sided alpha level of 2.5%. A 2-sided 95% confidence interval (CI) was also planned to be provided around the difference between treatments, where non-inferiority would also be demonstrated if the upper bound of the 95% CI is less than or equal to the NI margin of 5 units. In this scenario, the 2-sided 95% CI equates to testing the 1-sided non-inferiority hypothesis.|Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|0.36|<|0.001|TWO_SIDED|95.0|-0.4|1.0||The p-value to test non-inferiority of FRESCA Mask compared with CPAP Mask (FRESCA-CPAP\<5 units) assumes a 1-sided test using a level of significance of 2.5% and NI margin of 5 units.|t-test, 1 sided||The mean ODI values are rounded to a single decimal point value in the text of the table (1.4 and 1.1, respectively) to ensure consistency with ODI reporting standards.|This analysis was planned to assume a non-inferiority (NI) margin of 5 units and a 1-sided alpha level of 2.5%. A 2-sided 95% confidence interval (CI) was also planned to be provided around the difference between treatments, where non-inferiority would also be demonstrated if the upper bound of the 95% CI is less than or equal to the NI margin of 5 units. In this scenario, the 2-sided 95% CI equates to testing the 1-sided non-inferiority hypothesis.||1.0|-0.4|<0.001
70945992|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2689|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2689
70945993|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6907|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6907
70945994|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4798|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4798
70945995|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5609|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5609
70945996|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9834|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9834
70945997|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8339|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8339
71087947|NCT04210986|141682321|SUPERIORITY||Contrast of LS Means|10.5||||0.748|TWO_SIDED|95.0|-12.9|33.9||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||33.9|-12.9|0.7480
71125616|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||7.44|TWO_SIDED|95.0|0.76|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LLL; D12 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.76|7.44
71125617|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||56.35|TWO_SIDED|95.0|0.87|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.18|0.87|56.35
71125618|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.93||||4.03|TWO_SIDED|95.0|0.87|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.87|4.03
70945998|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.873|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8730
70945999|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6327|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6327
70946000|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3986|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3986
70946001|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.637|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6370
70946002|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9869|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9869
70946003|NCT00551135|141392967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.755|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7550
70946004|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2912|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2912
71125619|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||24.79|TWO_SIDED|95.0|0.89|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.89|24.79
71125620|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||77.08|TWO_SIDED|95.0|0.95|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.12|0.95|77.08
71125621|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||23.07|TWO_SIDED|95.0|0.89|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.89|23.07
71125622|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||18.58|TWO_SIDED|95.0|0.88|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.88|18.58
70946005|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3723|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3723
70946006|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6116|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6116
70946007|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0835|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0835
70946008|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1497|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1497
70946009|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.395|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3950
70946010|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5892|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5892
70946011|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6143|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6143
71125623|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||44.94|TWO_SIDED|95.0|0.92|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.92|44.94
70946012|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0104|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0104
71125624|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||2.21|TWO_SIDED|95.0|0.8|1.0||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.00|0.80|2.21
71125625|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||6.09|TWO_SIDED|95.0|0.83|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.83|6.09
71125626|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||66.6|TWO_SIDED|95.0|0.92|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.92|66.60
71125627|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.9||||3.23|TWO_SIDED|95.0|0.81|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.81|3.23
71125628|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||20.83|TWO_SIDED|95.0|0.86|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.86|20.83
71125629|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||87.6|TWO_SIDED|95.0|0.96|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.96|87.60
70946013|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5666|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5666
70946014|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9008|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9008
70946015|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0967|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0967
70946016|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8353|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8353
70946017|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.453|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4530
71125630|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.93||||7.9|TWO_SIDED|95.0|0.84|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.84|7.90
71125631|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||23.39|TWO_SIDED|95.0|0.87|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.87|23.39
71125632|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||76.16|TWO_SIDED|95.0|0.95|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.12|0.95|76.16
71125633|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||22.54|TWO_SIDED|95.0|0.87|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal;Region; Upper; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.87|22.54
71125634|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||58.17|TWO_SIDED|95.0|0.91|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Upper; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.12|0.91|58.17
71125635|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||6.22|TWO_SIDED|95.0|0.76|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Lower; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.76|6.22
71125636|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||55.85|TWO_SIDED|95.0|0.88|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Lower; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.88|55.85
71125637|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||25.44|TWO_SIDED|95.0|0.96|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region;Central; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.96|25.44
70946018|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7297|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7297
70946019|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0692|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0692
70857274|NCT02081248|141200836|SUPERIORITY|||||||0.37||||||Testing was performed at a significance level of 0.05|t-test, 2 sided|Two-sample t-test comparing mean QuIC-A scores performed using 150 degrees of freedom||The null hypothesis is that there is no difference in comprehension of the parent clinical trial, as measured by the QuIC-A, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Mean QuIC-A scores were compared between arms, which should be approximately equal under the null hypothesis.||||0.37
70946020|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6333|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6333
70946021|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0325|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0325
70946022|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5788|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5788
70946023|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9224|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9224
70946024|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5527|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5527
71125638|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||18.15|TWO_SIDED|95.0|0.96|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal;Region; Cetral; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.96|18.15
71125639|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||8.12|TWO_SIDED|95.0|0.82|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Distal; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.82|8.12
71125640|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||57.39|TWO_SIDED|95.0|0.9|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Distal D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.90|57.39
71125641|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||10|TWO_SIDED|95.0|0.93|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region;Total; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.93|10.00
71125642|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||29.88|TWO_SIDED|95.0|0.95|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Total; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.95|29.88
71125643|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||12.63|TWO_SIDED|95.0|0.89|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.89|12.63
71125644|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||32.29|TWO_SIDED|95.0|0.91|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; SCRD28 The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.91|32.29
71125645|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||69.92|TWO_SIDED|95.0|0.95|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.10|0.95|69.92
70946025|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2624|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2624
70946026|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3263|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3263
70946027|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3746|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3746
70946028|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0050
70946029|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0493|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0493
70946030|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0773|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0773
70946031|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0547|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0547
70946032|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1976|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1976
71125646|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.93||||6.1|TWO_SIDED|95.0|0.84|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.84|6.10
71125647|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||33.63|TWO_SIDED|95.0|0.89|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.89|33.63
71125648|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||86.07|TWO_SIDED|95.0|0.97|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.97|86.07
70946033|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3832|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3832
70946034|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4216|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4216
70946035|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5852|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5852
70946036|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7336|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7336
70946037|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1647|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1647
70857275|NCT02081248|141200837|SUPERIORITY|||||||0.39||||||Testing performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in participants' perception of their comprehension of the parent clinical trial, as measured by the QuIC-B, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median QuIC-B scores were compared between arms, which should be approximately equal under the null hypothesis.||||0.39
70857276|NCT02081248|141200838|SUPERIORITY|||||||0.17||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in participants' comprehension of the parent clinical trial, as measured by the DICCT, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median DICCT scores were compared between arms, which should be approximately equal under the null hypothesis.||||0.17
70946038|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2813|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2813
71087948|NCT04210986|141682321|SUPERIORITY||Contrast of LS Means|-0.6||||0.9572|TWO_SIDED|95.0|-22.2|21.1||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||21.1|-22.2|0.9572
70946039|NCT00551135|141392968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8423|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8423
71087949|NCT04210986|141682322|SUPERIORITY||Contrast of LS Means|0.01|||>|0.99|TWO_SIDED|95.0|-0.47|0.49||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.49|-0.47|>0.99
71087950|NCT04210986|141682322|SUPERIORITY||Contrast of LS Means|0.07|||>|0.99|TWO_SIDED|95.0|-0.33|0.47||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.47|-0.33|>0.99
71087951|NCT04210986|141682323|SUPERIORITY||Contrast of LS Means|-0.37|||>|0.99|TWO_SIDED|95.0|-1.61|0.87||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.87|-1.61|>0.99
71087952|NCT04210986|141682323|SUPERIORITY||Contrast of LS Means|0.16|||>|0.99|TWO_SIDED|95.0|-0.8|1.13||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||1.13|-0.80|>0.99
71087953|NCT04210986|141682324|SUPERIORITY||Contrast of LS Means|-0.022||||0.13|TWO_SIDED|95.0|-0.045|0.002||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.002|-0.045|0.130
71087954|NCT04210986|141682324|SUPERIORITY||Contrast of LS Means|-0.024||||0.13|TWO_SIDED|95.0|-0.049|0.002||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.002|-0.049|0.130
71087955|NCT04210986|141682325|SUPERIORITY||Contrast of LS Means|-0.22||||0.9584|TWO_SIDED|95.0|-0.84|0.4||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.40|-0.84|0.9584
71125649|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||41.38|TWO_SIDED|95.0|0.96|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.96|41.38
71125650|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||24.88|TWO_SIDED|95.0|0.96|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.96|24.88
71125651|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||29.89|TWO_SIDED|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.97|29.89
70857277|NCT02081248|141200841|SUPERIORITY|||||||0.21||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in participants' state anxiety, as measured by the STAI, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median state anxiety subscores of the STAI were compared between arms, which should be equal under the null hypothesis.||||0.21
71125652|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.94||||7.13|TWO_SIDED|95.0|0.87|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.87|7.13
71125653|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||32.91|TWO_SIDED|95.0|0.9|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.90|32.91
71125654|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||81.15|TWO_SIDED|95.0|0.96|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.96|81.15
71125655|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||21.87|TWO_SIDED|95.0|0.95|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.95|21.87
71125656|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||24.49|TWO_SIDED|95.0|0.95|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.95|24.49
71125657|NCT02294734|141757727|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||55.52|TWO_SIDED|95.0|0.97|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.97|55.52
71125658|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||59.55|TWO_SIDED|95.0|0.84|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|(FRC; Longitudinal; Lobes; RUL; D12, The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.25|0.84|59.55
71125659|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.18||||94.01|TWO_SIDED|95.0|0.96|1.46||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|(FRC; Longitudinal; Lobes; RUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.46|0.96|94.01
71125660|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.1||||82.27|TWO_SIDED|95.0|0.9|1.33||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LUL; D12, The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.33|0.90|82.27
71125661|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.31||||99.22|TWO_SIDED|95.0|1.06|1.61||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.61|1.06|99.22
70857278|NCT02081248|141200841|SUPERIORITY|||||||0.25||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in participants' trait anxiety, as measured by the STAI, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median trait anxiety subscores of the STAI were compared between arms, which should be equal under the null hypothesis.||||0.25
71087956|NCT04210986|141682325|SUPERIORITY||Contrast of LS Means|0.12||||0.9584|TWO_SIDED|95.0|-0.69|0.92||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.92|-0.69|0.9584
71087957|NCT04210986|141682326|SUPERIORITY||Contrast of LS Means|1.88||||0.5905|TWO_SIDED|95.0|-5.07|8.84||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||8.84|-5.07|0.5905
71087958|NCT04210986|141682326|SUPERIORITY||Contrast of LS Means|3.86||||0.5414|TWO_SIDED|95.0|-3.08|10.79||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||10.79|-3.08|0.5414
71087959|NCT04210986|141682327|SUPERIORITY||Contrast of LS Means|0.05|||>|0.99|TWO_SIDED|95.0|-0.75|0.85||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 3 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.85|-0.75|>0.99
71087960|NCT04210986|141682327|SUPERIORITY||Contrast of LS Means|0.44|||>|0.99|TWO_SIDED|95.0|-0.45|1.34||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||1.34|-0.45|>0.99
71087961|NCT04210986|141682327|SUPERIORITY||Contrast of LS Means|0.42|||>|0.99|TWO_SIDED|95.0|-0.7|1.54||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 9 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||1.54|-0.70|>0.99
71087962|NCT04210986|141682327|SUPERIORITY||Contrast of LS Means|-0.06|||>|0.99|TWO_SIDED|95.0|-0.91|0.78||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.78|-0.91|>0.99
71087963|NCT04210986|141682327|SUPERIORITY||Contrast of LS Means|-0.47|||>|0.99|TWO_SIDED|95.0|-1.5|0.56||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 15 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.56|-1.50|>0.99
71087964|NCT04210986|141682327|SUPERIORITY||Contrast of LS Means|-0.19|||>|0.99|TWO_SIDED|95.0|-1.16|0.77||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 18 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.77|-1.16|>0.99
71087965|NCT04210986|141682327|SUPERIORITY||Contrast of LS Means|0.19|||>|0.99|TWO_SIDED|95.0|-0.58|0.96||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 21 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.96|-0.58|>0.99
71087966|NCT04210986|141682327|SUPERIORITY||Contrast of LS Means|0.1|||>|0.99|TWO_SIDED|95.0|-0.76|0.97||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 24 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.97|-0.76|>0.99
71087967|NCT04210986|141682327|SUPERIORITY||Contrast of LS Means|0.01|||>|0.99|TWO_SIDED|95.0|-0.74|0.76||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 27 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.76|-0.74|>0.99
71125662|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||46.24|TWO_SIDED|95.0|0.75|1.29||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RML; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.29|0.75|46.24
71125663|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.29||||98.3|TWO_SIDED|95.0|1.02|1.64||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RML; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.64|1.02|98.30
71125664|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.25||||92.6|TWO_SIDED|95.0|0.92|1.7||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.70|0.92|92.60
71125665|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.38||||99.01|TWO_SIDED|95.0|1.05|1.81||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.81|1.05|99.01
71125666|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||58.8|TWO_SIDED|95.0|0.82|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.28|0.82|58.80
71125667|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.13||||86.82|TWO_SIDED|95.0|0.91|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.42|0.91|86.82
71125668|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||67.37|TWO_SIDED|95.0|0.92|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.92|67.37
71125669|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.14||||98.35|TWO_SIDED|95.0|1.01|1.29||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.29|1.01|98.35
71125670|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.1||||96.86|TWO_SIDED|95.0|0.99|1.23||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.23|0.99|96.86
71125671|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||86.18|TWO_SIDED|95.0|0.95|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.95|86.18
70946040|NCT00551135|141392969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.397|TWO_SIDED||||||ANOVA|||"Sitting; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by sitting. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.3970
70946041|NCT00551135|141392969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.764|TWO_SIDED||||||ANOVA|||"Sitting; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by sitting. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.7640
70946042|NCT00551135|141392969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5064|TWO_SIDED||||||ANOVA|||"Sitting; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by sitting. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.5064
70946043|NCT00551135|141392969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1318|TWO_SIDED||||||ANOVA|||"Walking; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by walking. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.1318
70946044|NCT00551135|141392969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9367|TWO_SIDED||||||ANOVA|||"Walking; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by walking. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.9367
71125672|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.16||||98.89|TWO_SIDED|95.0|1.02|1.31||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.31|1.02|98.89
71125673|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||91.94|TWO_SIDED|95.0|0.97|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.97|91.94
71125674|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||55.32|TWO_SIDED|95.0|0.88|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.88|55.32
71125675|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.15||||97.17|TWO_SIDED|95.0|1.0|1.32||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.32|1.00|97.17
71125676|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.14||||96.57|TWO_SIDED|95.0|0.99|1.32||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.32|0.99|96.57
70857279|NCT02081248|141200842|SUPERIORITY|||||||0.8||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in satisfaction with the consent process, as measured by a study-specific questionnaire, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median participant satisfaction scores were compared between arms, which should be equal under the null hypothesis.||||0.80
70857280|NCT02081248|141200843|SUPERIORITY|||||||0.73||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the time required to find the main goal of the study between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find the main goal of the study was compared between arms, which should be equal under the null hypothesis.||||0.73
70857281|NCT02081248|141200843|SUPERIORITY|||||||0.26||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the time required to find who to contact for questions between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find who to contact for questions was compared between arms, which should be equal under the null hypothesis.||||0.26
70857282|NCT02081248|141200843|SUPERIORITY|||||||0.74||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the time required to find the risks and benefits section between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find the risks and benefits section was compared between arms, which should be equal under the null hypothesis.||||0.74
71125677|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||79.13|TWO_SIDED|95.0|0.9|1.27||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.27|0.90|79.13
71125678|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.22||||99.54|TWO_SIDED|95.0|1.05|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.42|1.05|99.54
71125679|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.14||||97.8|TWO_SIDED|95.0|1.0|1.3||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.30|1.00|97.80
71125680|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||71.94|TWO_SIDED|95.0|0.91|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.91|71.94
71125681|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||85.3|TWO_SIDED|95.0|0.94|1.23||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.23|0.94|85.30
70946045|NCT00551135|141392969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1259|TWO_SIDED||||||ANOVA|||"Walking; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by walking. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.1259
70946046|NCT00551135|141392969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1812|TWO_SIDED||||||ANOVA|||"Coughing; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by coughing. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.1812
71125682|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||82.15|TWO_SIDED|95.0|0.94|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.94|82.15
71125683|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||72.55|TWO_SIDED|95.0|0.88|1.27||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal;Region; Upper; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.27|0.88|72.55
70857283|NCT02081248|141200843|SUPERIORITY|||||||0.56||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the time required to find how to leave the study between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find how to leave the study was compared between arms, which should be equal under the null hypothesis.||||0.56
70857284|NCT02081248|141200843|SUPERIORITY|||||||0.79||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the time required to find study procedures between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find study procedures was compared between arms, which should be equal under the null hypothesis.||||0.79
70946047|NCT00551135|141392969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96|TWO_SIDED||||||ANOVA|||"Coughing; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by coughing. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.9600
71125684|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.22||||98.44|TWO_SIDED|95.0|1.02|1.47||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Upper; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.47|1.02|98.44
71125685|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.11||||78.24|TWO_SIDED|95.0|0.86|1.43||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Lower; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.43|0.86|78.24
71125686|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.23||||96.8|TWO_SIDED|95.0|0.99|1.52||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Lower; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.52|0.99|96.80
71125687|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||91.11|TWO_SIDED|95.0|0.97|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region;Central; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.97|91.11
71125688|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||89.3|TWO_SIDED|95.0|0.97|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal;Region; Cetral; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.97|89.30
71125689|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||74.67|TWO_SIDED|95.0|0.87|1.32||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Distal; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.32|0.87|74.67
71125690|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.23||||98.25|TWO_SIDED|95.0|1.02|1.48||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Distal D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.48|1.02|98.25
71125691|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||87.8|TWO_SIDED|95.0|0.96|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region;Total; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.18|0.96|87.80
71087968|NCT04210986|141682327|SUPERIORITY||Contrast of LS Means|-0.38|||>|0.99|TWO_SIDED|95.0|-1.2|0.44||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 30 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.44|-1.20|>0.99
71087969|NCT04210986|141682327|SUPERIORITY||Contrast of LS Means|0.1|||>|0.99|TWO_SIDED|95.0|-0.69|0.89||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 33 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.89|-0.69|>0.99
71087970|NCT04210986|141682327|SUPERIORITY||Contrast of LS Means|-0.2|||>|0.99|TWO_SIDED|95.0|-1.02|0.61||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 36 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.61|-1.02|>0.99
71087971|NCT04210986|141682327|SUPERIORITY||Contrast of LS Means|0.11|||>|0.99|TWO_SIDED|95.0|-0.7|0.92||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 39 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.92|-0.70|>0.99
71087972|NCT04210986|141682327|SUPERIORITY||Contrast of LS Means|-0.62|||>|0.99|TWO_SIDED|95.0|-1.36|0.13||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 42 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.13|-1.36|>0.99
71087973|NCT04210986|141682327|SUPERIORITY||Contrast of LS Means|-0.23|||>|0.99|TWO_SIDED|95.0|-1.01|0.55||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|WEEK 7 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.55|-1.01|>0.99
71087974|NCT04210986|141682327|SUPERIORITY||Contrast of LS Means|-0.2|||>|0.99|TWO_SIDED|95.0|-0.89|0.49||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|WEEK 8 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.49|-0.89|>0.99
71087975|NCT04210986|141682327|SUPERIORITY||Contrast of LS Means|0.02|||>|0.99|TWO_SIDED|95.0|-0.63|0.67||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|WEEK 9 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.67|-0.63|>0.99
71087976|NCT04210986|141682327|SUPERIORITY||Contrast of LS Means|-0.17|||>|0.99|TWO_SIDED|95.0|-0.95|0.61||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|WEEK 10 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.61|-0.95|>0.99
71087977|NCT04210986|141682327|SUPERIORITY||Contrast of LS Means|-0.42|||>|0.99|TWO_SIDED|95.0|-1.18|0.34||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|WEEK 11 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.34|-1.18|>0.99
71087978|NCT04210986|141682327|SUPERIORITY||Contrast of LS Means|-0.35|||>|0.99|TWO_SIDED|95.0|-1.41|0.71||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|WEEK 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.71|-1.41|>0.99
71125692|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||91.54|TWO_SIDED|95.0|0.97|1.15||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Total; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.15|0.97|91.54
70857285|NCT02081248|141200844|SUPERIORITY|||||||1||||||Testing was performed at a significance level of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in the consent rates to BMT CTN 0901 between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Consent rates to BMT CTN 0901 were compared between arms in participants considering enrollment, which should be equal under the null hypothesis.||||1.00
70857286|NCT02081248|141200844|SUPERIORITY|||||||0.77||||||Testing was performed at a significance level of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in the consent rates to BMT CTN 1101 between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Consent rates to BMT CTN 1101 were compared between arms in participants considering enrollment, which should be approximately equal under the null hypothesis.||||0.77
71087979|NCT04210986|141682328|SUPERIORITY||Contrast of LS Means|1.86||||0.9106|TWO_SIDED|95.0|-3.09|6.82||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||6.82|-3.09|0.9106
71087980|NCT04210986|141682328|SUPERIORITY||Contrast of LS Means|-4.2||||0.4424|TWO_SIDED|95.0|-9.93|1.53||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||1.53|-9.93|0.4424
71087981|NCT04210986|141682328|SUPERIORITY||Contrast of LS Means|-0.03||||0.9901|TWO_SIDED|95.0|-5.55|5.48||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 18 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||5.48|-5.55|0.9901
71087982|NCT04210986|141682329|SUPERIORITY||Contrast of LS Means|0.69|||>|0.99|TWO_SIDED|95.0|-30.95|32.3||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|"MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.~A priori power calculation was based a standardized mean difference effect size of SMD=0.73 (Mackay, et al, 2018, Osteoarthritis and Cartilage)."||32.3|-30.95|>0.99
71125693|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||68.89|TWO_SIDED|95.0|0.92|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.92|68.89
71125694|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.13||||98.19|TWO_SIDED|95.0|1.01|1.27||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.27|1.01|98.19
71125695|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||94.07|TWO_SIDED|95.0|0.98|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.98|94.07
71125696|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||75.74|TWO_SIDED|95.0|0.92|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.92|75.74
71125697|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.12||||95.83|TWO_SIDED|95.0|0.99|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.28|0.99|95.83
71087983|NCT04210986|141682329|SUPERIORITY||Contrast of LS Means|-11.3|||>|0.99|TWO_SIDED|95.0|-46.9|24.2||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|"MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.~A priori power calculation was based a standardized mean difference effect size of SMD=0.73 (Mackay, et al, 2018, Osteoarthritis and Cartilage)."||24.2|-46.9|>0.99
71087984|NCT04210986|141682330|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.474|TWO_SIDED|95.0|0.05|4.21||A priori threshold for statistical significance = 0.05.|Log Rank|Cox proportional hazards model constructed. Score (log rank) test to assess between group difference in hazard rate.|Hazard ratio expresses the hazard rate of the Fisetin group in the numerator and the hazard rate of the Placebo group in the denominator|With only 4 participants that converted to an alternative treatment modality, this analysis is underpowered.||4.21|0.05|0.474
71125698|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||79.8|TWO_SIDED|95.0|0.94|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.94|79.80
71125699|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||95.29|TWO_SIDED|95.0|0.99|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Central; SCRD12 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.99|95.29
71125700|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||96.27|TWO_SIDED|95.0|0.99|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.99|96.27
71125701|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||47.62|TWO_SIDED|95.0|0.94|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.94|47.62
71125702|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||71.55|TWO_SIDED|95.0|0.92|1.15||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.15|0.92|71.55
71125703|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.13||||98.29|TWO_SIDED|95.0|1.01|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.28|1.01|98.29
71125704|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Bayesian repeated measures model|1.08||||95.09|TWO_SIDED|95.0|0.99|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.99|95.09
71125705|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||93.68|TWO_SIDED|95.0|0.98|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.98|93.68
71087985|NCT02965924|141682335|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71125706|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||96.58|TWO_SIDED|95.0|1.0|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|1.00|96.58
71125707|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||56.99|TWO_SIDED|95.0|0.95|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.95|56.99
71125708|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.94||||13.08|TWO_SIDED|95.0|0.85|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.85|13.08
71125709|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||52.99|TWO_SIDED|95.0|0.89|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.89|52.99
71125710|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||60.75|TWO_SIDED|95.0|0.9|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.90|60.75
71125711|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||75.23|TWO_SIDED|95.0|0.92|1.2||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.20|0.92|75.23
71125712|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||28.14|TWO_SIDED|95.0|0.78|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RML; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.78|28.14
71125713|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||38.43|TWO_SIDED|95.0|0.84|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RML; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.84|38.43
71125714|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||25.21|TWO_SIDED|95.0|0.8|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.12|0.80|25.21
71125715|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||81.73|TWO_SIDED|95.0|0.91|1.27||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.27|0.91|81.73
71125716|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.9||||9.87|TWO_SIDED|95.0|0.76|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.76|9.87
71087986|NCT01474486|141682345|OTHER|||||||0.64|||||||Mixed Models Analysis|||||||0.64
71087987|NCT04233879|141682384|NON_INFERIORITY|Non-inferiority was concluded if the upper bound of the 2-sided multiplicity-adjusted 95% confidence interval (95%CI) was less than 10 percentage points.|Treatment Difference|0.6|||||TWO_SIDED|95.0|-4.5|5.8|||||Unstratified Miettinen and Nurminen method was used to generate the treatment difference and the associated 95%CI.|||5.8|-4.5|
71087988|NCT04233879|141682385|OTHER|Difference between treatment groups (Group 1: DOR/ISL and Group 2: BIC/FTC/TAF)|Percentage Difference|4.3|||||TWO_SIDED|95.0|-0.8|9.6|||||Miettinen \& Nurminen method was used to generate percentage difference and the associated 95%CI.|||9.6|-0.8|
71087989|NCT04233879|141682386|OTHER|Difference between treatment groups (Group 1: DOR/ISL and Group 2: BIC/FTC/TAF)|Percentage Difference|4.0|||||TWO_SIDED|95.0|0.4|7.9|||||Miettinen \& Nurminen method was used to generate percentage difference and the associated 95%CI.|||7.9|0.4|
71087990|NCT04233879|141682389|NON_INFERIORITY|Non-inferiority was concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI was less than 10 percentage points.|Treatment Difference|2.3|||||TWO_SIDED|95.0|-3.1|7.7|||||Miettinen and Nurminen method was used to generate treatment difference and the associated 95%CI.|||7.7|-3.1|
71087991|NCT04233879|141682390|NON_INFERIORITY|Non-inferiority was concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI was less than 10 percentage points.|Treatment Difference|1.0|||||TWO_SIDED|95.0|-4.1|6.1|||||Miettinen and Nurminen method was used to generate treatment difference and the associated 95%CI.|||6.1|-4.1|
71087992|NCT04233879|141682401|SUPERIORITY|Superiority will be concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI was less than 0.|Treatment Difference|0.15||||0.73|TWO_SIDED|95.0|-0.71|1.02|||ANCOVA|A 2-sided p-value was calculated using the Analysis of covariance (ANCOVA) model.|ANCOVA model was used to generate treatment difference and the associated 95%CI.|||1.02|-0.71|0.73
71087993|NCT03585270|141682412|SUPERIORITY||Relative Risk Reduction|0.072||||0.7338|TWO_SIDED|95.0|-0.426|0.396|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.2785).|||0.396|-0.426|0.7338
71087994|NCT03585270|141682413|SUPERIORITY||Relative Risk Reduction|0.341||||0.177|TWO_SIDED|95.0|-0.213|0.642|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.8644).|||0.642|-0.213|0.177
71087995|NCT03585270|141682414|SUPERIORITY||Relative Risk Reduction|-0.254||||0.1983|TWO_SIDED|95.0|-0.76|0.107|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.8844).|||0.107|-0.760|0.1983
71087996|NCT03585270|141682415|SUPERIORITY||Relative Risk Reduction|-0.254||||0.1983|TWO_SIDED|95.0|-0.76|0.107|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.8844).|||0.107|-0.760|0.1983
71125717|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||63.15|TWO_SIDED|95.0|0.87|1.21||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.21|0.87|63.15
71087997|NCT03585270|141682416|SUPERIORITY||Relative Risk Reduction|0.119||||0.5591|TWO_SIDED|95.0|-0.349|0.425|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.1706).|||0.425|-0.349|0.5591
71087998|NCT03585270|141682417|SUPERIORITY||Relative Risk Reduction|0.267||||0.1179|TWO_SIDED|95.0|-0.085|0.505|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.4580)|||0.505|-0.085|0.1179
71087999|NCT03585270|141682418|SUPERIORITY||Relative Risk Reduction|0.139||||0.5217|TWO_SIDED|95.0|-0.365|0.457|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.1685)|||0.457|-0.365|0.5217
71088000|NCT03292016|141682419|OTHER||Geometric Mean ratio (APL-130277/APOKYN)|12.3|||||TWO_SIDED|90.0|7.5|20.3|||Mixed Models Analysis|With fixed effects-treatment and period, random effect-subject nested within sequence to analyze natural-log transformed dose normalized parameter.||Sample size of 12 subjects, a two-sided 90% CI for the difference in paired PK parameter means on the log scale will have an interval that extends no more than 0.221 units from the observed difference with 90% coverage probability. Assumes CV of 35% for the difference on the original scale.||20.3|7.5|
71088001|NCT03292016|141682419|OTHER||Geometric Mean ratio (APL-130277/APO-go)|10.3|||||TWO_SIDED|90.0|6.5|16.3||||||||16.3|6.5|
71088002|NCT03292016|141682419|OTHER|relative bioavailibilty|Geometric Mean ratio (APOKYN/APO-go)|83.4|||||TWO_SIDED|90.0|50.5|137.6||||||||137.6|50.5|
71088003|NCT03292016|141682419|OTHER||Ratio|0.21|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 20 mg and APO-Go 3 mg|||||
71088004|NCT03292016|141682419|OTHER||Ratio|0.13|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 20 mg and APOKYN 3 mg|||||
71088005|NCT03292016|141682419|OTHER||Ratio|1.16|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 3 mg and APOKYN 3 mg|||||
71088006|NCT03292016|141682419|OTHER||Ratio|0.16|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 25 mg and APO-Go 4 mg|||||
71088007|NCT03292016|141682419|OTHER||Ratio|0.17|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 25 mg and APOKYN 4 mg|||||
71088008|NCT03292016|141682419|OTHER||Ratio|1.12|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 4 mg and APOKYN 4 mg|||||
71088009|NCT03292016|141682419|OTHER||Ratio|0.08|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 30 mg and APO-Go 5 mg|||||
71088010|NCT03292016|141682419|OTHER||Ratio|0.09|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 30 mg and APOKYN 5 mg|||||
71088011|NCT03292016|141682419|OTHER||Ratio|1.04|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 5 mg and APOKYN 5 mg|||||
71088012|NCT03292016|141682420|OTHER|||||||0.0625|||||||Sign test|||||||0.0625
71088013|NCT03292016|141682420|OTHER|||||||0.0313|||||||Sign test|||||||0.0313
71125718|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.93||||4.03|TWO_SIDED|95.0|0.86|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.86|4.03
71125719|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||30.03|TWO_SIDED|95.0|0.89|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.89|30.03
71125720|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||80.34|TWO_SIDED|95.0|0.95|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.95|80.34
71125721|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||25.65|TWO_SIDED|95.0|0.89|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.89|25.65
71088014|NCT03292016|141682420|OTHER||||||>|0.9999|||||||Sign test|||||||>0.9999
71088015|NCT03292016|141682421|OTHER||Geometric Mean Ratio (APL-130277/APOKYN)|17.2|||||TWO_SIDED|90.0|13.1|22.5|||Mixed Models Analysis|With fixed effects-treatment and period, random effect-subject nested within sequence to analyze natural-log transformed dose normalized parameter.||||22.5|13.1|
71088016|NCT03292016|141682421|OTHER||Geometric Mean Ratio (APL-130277/APOKYN)|16.7|||||TWO_SIDED|90.0|13.0|21.3|||Mixed Models Analysis|||||21.3|13.0|
71088017|NCT03292016|141682421|OTHER||Geometric Mean Ratio (APOKYN/APO-go)|96.9|||||TWO_SIDED|90.0|74.2|126.4||||||||126.4|74.2|
71088018|NCT03292016|141682421|OTHER||Ratio|0.32|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 20 mg and APO-Go 3 mg|||||
71088019|NCT03292016|141682421|OTHER||Ratio|0.16|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 20 mg and APOKYN 3 mg|||||
71088020|NCT03292016|141682421|OTHER||Ratio|1.09|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 3 mg and APOKYN 3 mg|||||
71088021|NCT03292016|141682421|OTHER||Ratio|0.23|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 25 mg and APO-Go 4 mg|||||
71088022|NCT03292016|141682421|OTHER||Ratio|0.23|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 25 mg and APOKYN 4 mg|||||
71088023|NCT03292016|141682421|OTHER||Ratio|1.0|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 4 mg and APOKYN 4 mg|||||
71088024|NCT03292016|141682421|OTHER||Ratio|0.15|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 30 mg and APO-Go 5 mg|||||
71088025|NCT03292016|141682421|OTHER||Ratio|0.14|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 30 mg and APOKYN 5 mg|||||
71088026|NCT03292016|141682421|OTHER||Ratio|0.96|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 5 mg and APOKYN 5 mg|||||
71088027|NCT03292016|141682422|OTHER||Geometric Mean Ratio (APL-130277/APOKYN)|17.6|||||TWO_SIDED|90.0|13.7|22.5|||Mixed Models Analysis|With fixed effects-treatment and period, random effect-subject nested within sequence to analyze natural-log transformed dose normalized parameter.||||22.5|13.7|
71088028|NCT03292016|141682422|OTHER||Geometric Mean Ratio (APL-130277/APO-go)|17.2|||||TWO_SIDED|90.0|13.7|21.6|||Mixed Models Analysis|||||21.6|13.7|
71088029|NCT03292016|141682422|OTHER||Geometric Mean Ratio (APOKYN/APO-go)|97.8|||||TWO_SIDED|90.0|76.6|124.8|||Mixed Models Analysis|||||124.8|76.6|
71088030|NCT03292016|141682427|OTHER|||||||0.0313|||||||Wilcoxon (Mann-Whitney)|||||||0.0313
71088031|NCT03292016|141682427|OTHER|||||||0.0625|||||||Wilcoxon (Mann-Whitney)|||||||0.0625
71088032|NCT03292016|141682427|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||||||>0.9999
71088033|NCT01038687|141682437|SUPERIORITY|||||||0.059|||||||ANCOVA|||||||0.059
71088034|NCT01038687|141682437|SUPERIORITY|||||||0.18|||||||Dunnett's test|||15mg dose vs placebo||||0.18
71088035|NCT01038687|141682437|SUPERIORITY|||||||0.04|||||||Dunnett's test|||20mg dose vs placebo||||0.04
71088036|NCT01038687|141682438|SUPERIORITY|||||||0.81|||||||ANCOVA|||||||0.81
71088037|NCT01038687|141682438|SUPERIORITY|||||||0.89|||||||Dunnett's test|||15mg dose vs placebo||||0.89
71088038|NCT01038687|141682438|SUPERIORITY|||||||0.76|||||||Dunnett's test|||20mg dose vs placebo||||0.76
70857287|NCT02081248|141200844|SUPERIORITY|||||||0.69||||||Testing was performed at a significance level of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in the consent rates to BMT CTN 1203 between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Consent rates to BMT CTN 1203 were compared between arms in participants considering enrollment, which should be approximately equal under the null hypothesis.||||0.69
70857288|NCT02081248|141200844|SUPERIORITY|||||||0.26||||||Testing was performed at a significance level of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in the consent rates to BMT CTN 1301 between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Consent rates to BMT CTN 1501 were compared between arms in participants considering enrollment, which should be approximately equal under the null hypothesis.||||0.26
70857289|NCT01879579|141200867|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Chi-squared|||||||<0.0001
70857290|NCT01879579|141200868|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Interval-censoring survival analysis|||||||0.007
70857291|NCT01879579|141200869|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.99
70857292|NCT01879579|141200870|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.78
70857293|NCT01879579|141200871|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.04
70857294|NCT01879579|141200872|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.13
70857295|NCT01879579|141200877|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Generalized estimating equation modeling|||||||0.008
70857296|NCT01879579|141200878|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.003
71088039|NCT01038687|141682439|SUPERIORITY|||||||0.075|||||||ANCOVA|||||||0.075
70857297|NCT02484859|141200892|SUPERIORITY||||||>|0.69|||||||Wilcoxon (Mann-Whitney)|||Median intraoperative bleeding scores were compared with Wilcoxon test. In this pilot study the power analysis showed that a sample size of 44 patients in each group was sufficient to detect a difference of 0.2 in the mean (standard deviation of 0.4) with an 80% power with an alpha error of 0.05 and a beta error of 20%. The Shapiro-Wilk test was used to test the distribution of data.||||>0.69
70857298|NCT02484859|141200893|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70857299|NCT02484859|141200894|SUPERIORITY|||||||0.052|||||||t-test, 2 sided|||||||0.052
70857300|NCT02484859|141200895|SUPERIORITY|||||||0.05|||||||Chi-squared|||Null hypothesis was that the visual analog pain scores (VAS) of patients at arrrival to post anesthetic care unit (PACU) were similar.||||0.05
70857301|NCT02484859|141200895|SUPERIORITY|||||||0.55|||||||Chi-squared|||Null hypothesis was that the visual analog pain scores (VAS) of patients at discharge from post anesthetic care unit (PACU) were similar.||||0.55
70857302|NCT02484859|141200896|SUPERIORITY|||||||0.47|||||||Chi-squared|||||||0.47
70857303|NCT03386253|141200898|SUPERIORITY|||||||0.77||||||Group x time p value|ANOVA|||||||0.77
71088040|NCT01038687|141682439|SUPERIORITY|||||||0.058|||||||Dunnett's test|||15mg dose vs placebo||||0.058
71088041|NCT01038687|141682439|SUPERIORITY|||||||0.164|||||||Dunnett's test|||20mg dose vs placebo||||0.164
71088042|NCT01038687|141682440|SUPERIORITY|||||||0.084|||||||ANCOVA|||||||0.084
71088043|NCT01038687|141682440|SUPERIORITY|||||||0.98|||||||Dunnett's test|||15mg vs placebo||||0.98
71088044|NCT01038687|141682440|SUPERIORITY|||||||0.079|||||||Dunnett's test|||20mg vs placebo||||0.079
71088045|NCT01038687|141682441|SUPERIORITY|||||||0.058|||||||ANCOVA|||||||0.058
71088046|NCT01038687|141682441|SUPERIORITY|||||||0.32|||||||Dunnett's test|||15mg dose vs placebo||||0.32
70946048|NCT00551135|141392969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.105|TWO_SIDED||||||ANOVA|||"Coughing; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by coughing. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.1050
70857304|NCT01949337|141200899|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.33|TWO_SIDED|95.0|0.8|1.08|||Log Rank|||||1.08|0.80|0.33
71088047|NCT01038687|141682441|SUPERIORITY|||||||0.034|||||||Dunnett's test|||20mg dose vs placebo||||0.034
71088048|NCT01038687|141682442|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.001
71088049|NCT01038687|141682442|SUPERIORITY|||||||0.002|||||||Dunnett's test|||15mg dose vs placebo||||0.002
71088050|NCT01038687|141682442|SUPERIORITY|||||||0.001|||||||Dunnett's test|||20mg vs placebo||||0.001
71088051|NCT01038687|141682443|SUPERIORITY|||||||0.091|||||||ANCOVA|||||||0.091
71088052|NCT01038687|141682443|SUPERIORITY|||||||0.99|||||||Dunnett's test|||15mg dose vs placebo||||0.99
71088053|NCT01038687|141682443|SUPERIORITY|||||||0.103|||||||Dunnett's test|||20mg vs placebo||||0.103
71088054|NCT01038687|141682444|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.001
71088055|NCT01038687|141682444|SUPERIORITY|||||||0.002|||||||Dunnett's test|||15mg dose vs placebo||||0.002
71088056|NCT01038687|141682444|SUPERIORITY|||||||0.001|||||||Dunnett's test|||20mg dose vs placebo||||0.001
70857305|NCT01842633|141200911|SUPERIORITY_OR_OTHER||Treatment Difference|-0.47|||||TWO_SIDED|95.0|-1.36|0.42||||||||0.42|-1.36|
71088057|NCT01038687|141682445|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
71088058|NCT01038687|141682445|SUPERIORITY|||||||0.053|||||||Dunnett's test|||15mg dose vs placebo||||0.053
71088059|NCT01038687|141682445|SUPERIORITY|||||||0.002|||||||Dunnett's test|||20mg dose vs placebo||||0.002
71088060|NCT01076543|141682460|OTHER||Maximum tolerated dose in mg|20.0|||||TWO_SIDED||||||||"The maximum tolerated dose (MTD) was determined using the traditional 3+3 design and was the maximum dose level such that less than 33% of the patients (i.e, \<1 of 3 or \<2 of 6) experience dose-limiting toxicity."|||||
71088061|NCT01076543|141682462|SUPERIORITY||||||>|0.1|||||||Binomial exact test|The number of responders required to reject the null hypothesis was 16 or more.||Two-stage, minimax design was used to test the null hypothesis that the overall response rate was 30% vs. a 50% alternative.||||>0.10
71088062|NCT01076543|141682462|SUPERIORITY|||||||||||||||||Two-stage, minimax design was used to test the null hypothesis that the overall response rate was 50% vs. 70% alternative.|The follicular subgroup did not reach its accrual goal and was closed.|||
71088063|NCT01076543|141682462|SUPERIORITY||||||<|0.1|||||||Binomial exact test.|The number of responders required to reject the null hypothesis was 16 or more.||Two-stage, minimax design was used to test the null hypothesis that the overall response rate was 30% vs. a 50% alternative.||||<0.10
71088064|NCT05222880|141682467|SUPERIORITY|A superiority Margin of 0.00 logMAR was used for distance.|Mean Population Estimate|-0.1|STANDARD_ERROR_OF_MEAN|0.007|||TWO_SIDED|99.0|-0.12|-0.08||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% Individually) with at least 99% statistical power, that 17 subjects were required to test the primary hypothesis for Distance.||-0.08|-0.12|
71088065|NCT05222880|141682467|SUPERIORITY|A superiority Margin of 0.17 logMAR was used for Intermediate.|Mean Population Estimate|-0.04|STANDARD_ERROR_OF_MEAN|0.007|||TWO_SIDED|99.0|-0.06|-0.02||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% Individually) with at least 99% statistical power, that 11 subjects were required to test the primary hypothesis for Intermediate.||-0.02|-0.06|
71088066|NCT05222880|141682467|SUPERIORITY|A superiority Margin of 0.17 logMAR was used for near.|Mean Population Estimate|0.07|STANDARD_ERROR_OF_MEAN|0.009|||TWO_SIDED|99.0|0.05|0.09||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% Individually) with at least 99% statistical power, that 48 subjects were required to test the primary hypothesis for Near.||0.09|0.05|
71088067|NCT05222880|141682468|SUPERIORITY|A superiority Margin of 36 CLUE Points was used for Hyperopes.|Mean Population Estimate|52.3|STANDARD_ERROR_OF_MEAN|2.75|||TWO_SIDED|99.0|45.2|59.4||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 99% statistical power, that 14 subjects were required to test for superiority for CLUE vision scores for Hyperopes.||59.4|45.2|
71088068|NCT05222880|141682468|SUPERIORITY|A superiority Margin of 41 CLUE Points was used for Myopes.|Mean Population Estimate|63.3|STANDARD_ERROR_OF_MEAN|2.054|||TWO_SIDED|99.0|58.0|68.6||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 99% statistical power, that 18 subjects were required to test for superiority for CLUE vision scores for Myopes.||68.6|58.0|
71088069|NCT05222880|141682469|SUPERIORITY|A superiority margin of 0.05 was used.|Mean Proportion|0.0019|STANDARD_DEVIATION|0.00209|||TWO_SIDED|95.0|0.0|0.0076|||Bayesian beta- binomial model|Bayesian beta-binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.02 and an intraclass correlation of 0.70 with 2000 replicating trials, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 90% with 95% central posterior credible.||0.0076|0.0000|
71088070|NCT05222880|141682470|SUPERIORITY|A superiority margin of 0.05 was used.|Mean Proportion|0.0018|STANDARD_DEVIATION|0.0021|||TWO_SIDED|95.0|0.0|0.0078|||Bayesian beta-binomial model|Bayesian beta-binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.02 and an intraclass correlation of 0.70 with 2000 replicating trials, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 90% with 95% central posterior credible.||0.0078|0.0000|
71125722|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||24.36|TWO_SIDED|95.0|0.88|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.88|24.36
71125723|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||48.45|TWO_SIDED|95.0|0.91|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.09|0.91|48.45
71125724|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||1.95|TWO_SIDED|95.0|0.81|0.99||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.99|0.81|1.95
71125725|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.94||||14.15|TWO_SIDED|95.0|0.85|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.85|14.15
71125726|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||80.61|TWO_SIDED|95.0|0.95|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.95|80.61
71125727|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.91||||3.3|TWO_SIDED|95.0|0.81|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD12.The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.81|3.30
71125728|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||42.22|TWO_SIDED|95.0|0.88|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.88|42.22
71125729|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.09||||95.24|TWO_SIDED|95.0|0.99|1.2||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; D12D28The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.20|0.99|95.24
71125730|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||6.38|TWO_SIDED|95.0|0.83|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.83|6.38
71125731|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||28.82|TWO_SIDED|95.0|0.86|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.09|0.86|28.82
71125732|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||87.39|TWO_SIDED|95.0|0.97|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.97|87.39
70946049|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2818|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2818
71088071|NCT05222880|141682471|SUPERIORITY|A superiority Margin of 41 CLUE Points was used for Hyperopes.|Mean Population Estimate|52.3|STANDARD_ERROR_OF_MEAN|2.75|||TWO_SIDED|99.0|45.2|59.4||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 80% statistical power, that 16 subjects were required to test for superiority for CLUE vision scores for Hyperopes.||59.4|45.2|
71088072|NCT05222880|141682471|SUPERIORITY|A superiority Margin of 46 CLUE Points was used for Myopes.|Mean Population Estimate|63.3|STANDARD_ERROR_OF_MEAN|2.054|||TWO_SIDED|99.0|58.0|68.6||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 80% statistical power, that 15 subjects were required to test for superiority for CLUE vision scores for Myopes.||68.6|58.0|
71088073|NCT05222880|141682472|SUPERIORITY|A Superiority margin of 52 CLUE points was used|Mean Population Estimate|72.6|STANDARD_ERROR_OF_MEAN|1.763|||TWO_SIDED|99.0|68.1|77.1||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 80% statistical power, that 11 subjects were required to test for superiority for CLUE comfort scores.||77.1|68.1|
70857306|NCT01555957|141200937|SUPERIORITY|||||||0.94|||||||Chi-squared|||we hypothesized that among ≥ 34 weeks GA infants with GISDs, infants receiving 1g/kg/day S-ILE (lipid minimizing strategy) would have decreased incidence of IFALD compared to those receiving 2g/kg/day S-ILE. We also hypothesized that the rate of rise of DB would be lower among ≥ 34 weeks GA infants with GISDs receiving 1g/kg/day versus 2g/kg/day of S-ILE.||||0.94
70857307|NCT01555957|141200938|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|||We also hypothesized that the rate of rise of direct bilirubin would be lower among ≥ 34 weeks GA infants with GISDs receiving 1g/kg/day versus 2g/kg/day of S-ILE.||||0.0005
70857308|NCT00718081|141200939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.48|STANDARD_ERROR_OF_MEAN|4.92|<|0.001|ONE_SIDED|95.0|||||ANCOVA|||||||<0.001
70857309|NCT00718081|141200939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.62|STANDARD_ERROR_OF_MEAN|4.86|<|0.001|ONE_SIDED|95.0|||||ANCOVA|||||||<0.001
70857310|NCT01931670|141200968|SUPERIORITY||||||<|0.001||||||An elagolix dose group was to be considered more efficacious than placebo for the co-primary endpoints if and only if both co-primary endpoints (DYS and NMPP) were statistically significant for the elagolix dose group at the 0.025 significance level.|Regression, Logistic|||||||< 0.001
70857311|NCT01931670|141200968|SUPERIORITY||||||<|0.001||||||An elagolix dose group was to be considered more efficacious than placebo for the co-primary endpoints if and only if both co-primary endpoints (DYS and NMPP) were statistically significant for the elagolix dose group at the 0.025 significance level.|Regression, Logistic|||||||< 0.001
70857312|NCT01931670|141200969|SUPERIORITY|||||||0.003||||||An elagolix dose group was to be considered more efficacious than placebo for the co-primary endpoints if and only if both co-primary endpoints (DYS and NMPP) were statistically significant for the elagolix dose group at the 0.025 significance level.|Regression, Logistic|||||||0.003
71125733|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||23.27|TWO_SIDED|95.0|0.87|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Upper; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.87|23.27
71125734|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||57.82|TWO_SIDED|95.0|0.9|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Upper; D28.The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.90|57.82
71125735|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.9||||9.67|TWO_SIDED|95.0|0.77|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Lower; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.77|9.67
71125736|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||70.73|TWO_SIDED|95.0|0.89|1.22||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Lower; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.22|0.89|70.73
71125737|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||25.61|TWO_SIDED|95.0|0.95|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Central; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.95|25.61
71125738|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||44.1|TWO_SIDED|95.0|0.96|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Cetral; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.96|44.10
70857313|NCT01931670|141200969|SUPERIORITY||||||<|0.001||||||An elagolix dose group was to be considered more efficacious than placebo for the co-primary endpoints if and only if both co-primary endpoints (DYS and NMPP) were statistically significant for the elagolix dose group at the 0.025 significance level.|Regression, Logistic|||||||< 0.001
70946050|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8631|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8631
70946051|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5074|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5074
71125739|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||10.14|TWO_SIDED|95.0|0.82|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Distal; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.82|10.14
71125740|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||62.87|TWO_SIDED|95.0|0.9|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Distal D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.90|62.87
71125741|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||11.82|TWO_SIDED|95.0|0.93|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Total; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.93|11.82
71125742|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||51.44|TWO_SIDED|95.0|0.95|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Total; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.95|51.44
71125743|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||9.54|TWO_SIDED|95.0|0.88|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.88|9.54
70857314|NCT01931670|141200970|SUPERIORITY||Difference in LS Mean Change|-0.57|STANDARD_ERROR_OF_MEAN|0.156|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 1 of 7.||||<0.001
70857315|NCT01931670|141200970|SUPERIORITY||Difference in LS Mean Change|-1.22|STANDARD_ERROR_OF_MEAN|0.156|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 1 of 7.||||< 0.001
71125744|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||30.03|TWO_SIDED|95.0|0.89|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.89|30.03
70946052|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0401|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0401
71088074|NCT05222880|141682473|SUPERIORITY|A Superiority margin of 53 CLUE points was used|Mean Population Estimate|67.6|STANDARD_ERROR_OF_MEAN|1.77|||TWO_SIDED|99.0|63.0|72.1||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 80% statistical power, that 17 subjects were required to test for superiority for CLUE handling scores.||72.1|63.0|
71088075|NCT05222880|141682474|SUPERIORITY|A superiority margin of 0.90 was used.|Mean Posterior Proportion|0.985|STANDARD_DEVIATION|0.0071|||TWO_SIDED|99.0|0.959|0.997|||Bayesian beta-binomial model|Bayesian beta-binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.98 and an intraclass correlation of 0.70 with 2000 replicating trials, that 92 subjects were required to test for superiority to achieve a minimum statistical power of 80% with 99% central posterior credible.||0.997|0.959|
71088076|NCT02368132|141682475|SUPERIORITY||Least squares mean difference|-8.73|STANDARD_ERROR_OF_MEAN|2.57|<|0.001|TWO_SIDED||||||Mixed Models Analysis||Estimated difference in least square means between Usual Care (reference) and Group Delivered TEP arm at 3 months.|||||<0.001
71088077|NCT02368132|141682475|SUPERIORITY||Least squares mean difference|-5.15|STANDARD_ERROR_OF_MEAN|2.42||0.04|TWO_SIDED||||||Mixed Models Analysis||Estimated difference in least square means between Usual Care (reference) and Individual Delivered TEP arm at 3 months.|||||0.04
71088078|NCT04232839|141682478|OTHER||Adjusted geometric mean (gMean) ratio(%)|85.9|||||TWO_SIDED|90.0|80.3|91.7|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =13.9.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||91.7|80.3|
71088079|NCT04232839|141682478|OTHER||Adjusted geometric mean (gMean) ratio(%)|72.6|||||TWO_SIDED|90.0|68.0|77.6|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =13.9.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||77.6|68.0|
71125745|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||73.03|TWO_SIDED|95.0|0.95|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.95|73.03
71125746|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||4.64|TWO_SIDED|95.0|0.83|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.83|4.64
71125747|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||42.13|TWO_SIDED|95.0|0.89|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.10|0.89|42.13
71125748|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||93.33|TWO_SIDED|95.0|0.98|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.98|93.33
70946053|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5509|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5509
71088080|NCT04232839|141682478|OTHER||Adjusted geometric mean (gMean) ratio(%)|92.4|||||TWO_SIDED|90.0|86.5|98.8|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =13.9.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||98.8|86.5|
71088081|NCT04232839|141682478|OTHER||Adjusted geometric mean (gMean) ratio(%)|76.6|||||TWO_SIDED|90.0|71.6|81.8|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =13.9.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||81.8|71.6|
71088082|NCT04232839|141682478|OTHER||Adjusted geometric mean (gMean) ratio(%)|133.4|||||TWO_SIDED|90.0|117.2|151.9|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =17.6.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'subjects' and 'treatment'. The effect 'subjects' were to be considered as random, while the effect 'treatment' was to be considered as fixed.||151.9|117.2|
71088083|NCT04232839|141682478|OTHER||Adjusted geometric mean (gMean) ratio(%)|114.2|||||TWO_SIDED|90.0|102.3|127.6|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =16.2.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'subjects' and 'treatment'. The effect 'subjects' were to be considered as random, while the effect 'treatment' was to be considered as fixed.||127.6|102.3|
71088084|NCT04232839|141682479|OTHER||Adjusted geometric mean (gMean) ratio(%)|85.5|||||TWO_SIDED|90.0|80.0|91.4|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =14.0.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||91.4|80.0|
71088085|NCT04232839|141682479|OTHER||Adjusted geometric mean (gMean) ratio(%)|72.1|||||TWO_SIDED|90.0|67.4|77.1|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =14.0.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||77.1|67.4|
71088086|NCT04232839|141682479|OTHER||Adjusted geometric mean (gMean) ratio(%)|92.2|||||TWO_SIDED|90.0|86.3|98.6|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =14.0.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||98.6|86.3|
70857316|NCT01931670|141200971|SUPERIORITY||Difference in LS Mean Change|-0.54|STANDARD_ERROR_OF_MEAN|0.074|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 2 of 7.||||< 0.001
70857317|NCT01931670|141200971|SUPERIORITY||Difference in LS Mean Change|-1.13|STANDARD_ERROR_OF_MEAN|0.074|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 2 of 7.||||< 0.001
70857318|NCT01931670|141200972|SUPERIORITY||Difference in LS Mean Change|-0.15|STANDARD_ERROR_OF_MEAN|0.056||0.009|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 3 of 7.||||0.009
70857319|NCT01931670|141200972|SUPERIORITY||Difference in LS Mean Change|-0.32|STANDARD_ERROR_OF_MEAN|0.056|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 3 of 7.||||< 0.001
70857320|NCT01931670|141200973|SUPERIORITY||Difference in LS Mean Change|-0.05|STANDARD_ERROR_OF_MEAN|0.044||0.26|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 4 of 7.||||0.26
70946054|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0004
71088087|NCT04232839|141682479|OTHER||Adjusted geometric mean (gMean) ratio(%)|75.5|||||TWO_SIDED|90.0|70.6|80.7|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =14.0.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||80.7|70.6|
70857321|NCT01931670|141200973|SUPERIORITY||Difference in LS Mean Change|-0.18|STANDARD_ERROR_OF_MEAN|0.044|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 4 of 7.||||< 0.001
70946055|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.707|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7070
70946056|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.384|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3840
70857322|NCT01931670|141200974|SUPERIORITY||Difference in LS Mean Change|-0.08|STANDARD_ERROR_OF_MEAN|0.048||0.088|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 5 of 7.||||0.088
70857323|NCT01931670|141200974|SUPERIORITY||Difference in LS Mean Change|-0.21|STANDARD_ERROR_OF_MEAN|0.048|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 5 of 7.||||< 0.001
70857324|NCT01931670|141200975|SUPERIORITY||Difference in LS Mean Change|-0.09|STANDARD_ERROR_OF_MEAN|0.067||0.172|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 6 of 7.||||0.172
70857325|NCT01931670|141200975|SUPERIORITY||Difference in LS Mean Change|-0.3|STANDARD_ERROR_OF_MEAN|0.067|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 6 of 7.||||< 0.001
70946057|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2732|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2732
70946058|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4418|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4418
71088088|NCT04232839|141682479|OTHER||Adjusted geometric mean (gMean) ratio(%)|134.2|||||TWO_SIDED|90.0|117.6|153.0|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =17.9.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'subjects' and 'treatment'. The effect 'subjects' were to be considered as random, while the effect 'treatment' was to be considered as fixed.||153.0|117.6|
70857326|NCT01931670|141200976|SUPERIORITY||Difference in LS Mean Change|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.968|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 7 of 7.||||0.968
70946059|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8379|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8379
70946060|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5944|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5944
70946061|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8139|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8139
71088089|NCT04232839|141682479|OTHER||Adjusted geometric mean (gMean) ratio(%)|114.8|||||TWO_SIDED|90.0|102.9|128.1|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =16.1.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'subjects' and 'treatment'. The effect 'subjects' were to be considered as random, while the effect 'treatment' was to be considered as fixed.||128.1|102.9|
71088090|NCT00767572|141682529|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Significance threshold p\<0.05|t-test, 2 sided|||Null hypothesis: pre-post brachial artery diameter changes do not differ between placebo and atorvastatin||||>0.05
71125749|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||27.33|TWO_SIDED|95.0|0.95|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.95|27.33
71125750|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||34.15|TWO_SIDED|95.0|0.96|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.96|34.15
71125751|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||58.42|TWO_SIDED|95.0|0.98|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.98|58.42
71125752|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.94||||5.93|TWO_SIDED|95.0|0.86|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.86|5.93
71125753|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||35.88|TWO_SIDED|95.0|0.89|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.89|35.88
71125754|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||86.41|TWO_SIDED|95.0|0.97|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.97|86.41
71125755|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||13.52|TWO_SIDED|95.0|0.94|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.94|13.52
71125756|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||32.84|TWO_SIDED|95.0|0.95|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Total; SCRD28 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.95|32.84
71125757|NCT02294734|141757728|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||78.09|TWO_SIDED|95.0|0.98|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.98|78.09
71088091|NCT01328964|141682530|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.51|0.974||The p-value is a comparison of the combined hospitalization/emergency department visit endpoint|Regression, Cox|||||0.974|0.51|<0.0001
70857327|NCT01931670|141200976|SUPERIORITY||Difference in LS Mean Change|-0.08|STANDARD_ERROR_OF_MEAN|0.03||0.007|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 7 of 7.||||0.007
70857328|NCT01931670|141200977|SUPERIORITY||Odds Ratio (OR)|2.361|||<|0.001|TWO_SIDED|97.5|1.507|3.697|||Regression, Logistic|||Month 1||3.697|1.507|< 0.001
70857329|NCT01931670|141200977|SUPERIORITY||Odds Ratio (OR)|4.185|||<|0.001|TWO_SIDED|97.5|2.707|6.469|||Regression, Logistic|||Month 1||6.469|2.707|< 0.001
70857330|NCT01931670|141200977|SUPERIORITY||Odds Ratio (OR)|2.795|||<|0.001|TWO_SIDED|97.5|1.811|4.312|||Regression, Logistic|||Month 2||4.312|1.811|< 0.001
70857331|NCT01931670|141200977|SUPERIORITY||Odds Ratio (OR)|10.378|||<|0.001|TWO_SIDED|97.5|6.615|16.282|||Regression, Logistic|||Month 2||16.282|6.615|< 0.001
70857332|NCT01931670|141200977|SUPERIORITY||Odds Ratio (OR)|3.178|||<|0.001|TWO_SIDED|97.5|2.084|4.845|||Regression, Logistic|||Month 4||4.845|2.084|< 0.001
70857333|NCT01931670|141200977|SUPERIORITY||Odds Ratio (OR)|15.216|||<|0.001|TWO_SIDED|97.5|9.429|24.554|||Regression, Logistic|||Month 4||24.554|9.429|< 0.001
70857334|NCT01931670|141200977|SUPERIORITY||Odds Ratio (OR)|2.548|||<|0.001|TWO_SIDED|97.5|1.683|3.859|||Regression, Logistic|||Month 5||3.859|1.683|< 0.001
70857335|NCT01931670|141200977|SUPERIORITY||Odds Ratio (OR)|14.055|||<|0.001|TWO_SIDED|97.5|8.716|22.664|||Regression, Logistic|||Month 5||22.664|8.716|< 0.001
70857336|NCT01931670|141200977|SUPERIORITY||Odds Ratio (OR)|2.536|||<|0.001|TWO_SIDED|97.5|1.685|3.816|||Regression, Logistic|||Month 6||3.816|1.685|< 0.001
70857337|NCT01931670|141200977|SUPERIORITY||Odds Ratio (OR)|10.106|||<|0.001|TWO_SIDED|97.5|6.434|15.874|||Regression, Logistic|||Month 6||15.874|6.434|< 0.001
70857338|NCT01931670|141200978|SUPERIORITY||Odds Ratio (OR)|1.191||||0.376|TWO_SIDED|97.5|0.765|1.855|||Regression, Logistic|||Month 1||1.855|0.765|0.376
70857339|NCT01931670|141200978|SUPERIORITY||Odds Ratio (OR)|1.376||||0.101|TWO_SIDED|97.5|0.89|2.127|||Regression, Logistic|||Month 1||2.127|0.890|0.101
70857340|NCT01931670|141200978|SUPERIORITY||Odds Ratio (OR)|1.358||||0.088|TWO_SIDED|97.5|0.909|2.029|||Regression, Logistic|||Month 2||2.029|0.909|0.088
70857341|NCT01931670|141200978|SUPERIORITY||Odds Ratio (OR)|2.208|||<|0.001|TWO_SIDED|97.5|1.488|3.278|||Regression, Logistic|||Month 2||3.278|1.488|< 0.001
70857342|NCT01931670|141200978|SUPERIORITY||Odds Ratio (OR)|1.678||||0.003|TWO_SIDED|97.5|1.136|2.477|||Regression, Logistic|||Month 4||2.477|1.136|0.003
71088092|NCT01328964|141682531|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.0|||<|0.001|TWO_SIDED|95.0|-19.0|-9.0||P-value is based on the differences in the total monthly asthma costs|Regression, Linear|||||-9|-19|<0.001
71088093|NCT01328964|141682532|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.751||||0.0495|TWO_SIDED|95.0|0.565|0.999||P-value is based on the comparison of combined endpoint of hospitalization/emergency department visits|Regression, Cox|||||0.999|0.565|0.0495
71088094|NCT01328964|141682533|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.0|||<|0.0001|TWO_SIDED|95.0|-28.0|-27.0||P-value is based on difference in total monthly asthma costs|Regression, Linear|||||-27|-28|<0.0001
71088095|NCT00828711|141682546|SUPERIORITY_OR_OTHER||Difference in Proportions|12.2||||0.057|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Adjusted for site effect|MVI 200 - MVI 100|The primary objective of this study is to compare the efficacy of MVI 100 and MVI 200 based on the proportion of vaginal deliveries within 24 hours. A minimum sample size of approximately 120 subjects per arm would provide 84 subjects per arm with vaginal delivery, which would ensure \>80% power (with two-sided alpha of 5%) to detect a 20% improvement in the proportion of women delivering vaginally within 24 hours||||0.057
71088096|NCT00828711|141682547|SUPERIORITY_OR_OTHER||Median Difference (Net)|-563.0||||0.018|TWO_SIDED|95.0|||||Log Rank||MVI 200 - MVI 100|Subjects who underwent a cesarean delivery during the first hospitalization were censored using the longest time interval from study drug administration to cesarean delivery during the first hospitalization, independent of treatment group. Subjects who, in their first hospitalization, were discharged prior to delivery or withdrew consent prior to delivery were censored using the longest time interval from study drug administration to labor and delivery discharge, independent of treatment group.||||0.018
71088097|NCT00828711|141682549|SUPERIORITY_OR_OTHER||Difference in Proportions|-8.46||||0.153|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - MVI 100|||||0.153
71088098|NCT00828711|141682550|SUPERIORITY_OR_OTHER||Difference in Proportions|2.37||||0.65|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Adjusted for site effect|MVI 200 - MVI 100|||||0.65
71088099|NCT00828711|141682551|SUPERIORITY_OR_OTHER||Difference in Proportions|-22.09|||<|0.001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Adjusted for site effect|MVI 200 - MVI 100|||||<.001
71088100|NCT00828711|141682553|SUPERIORITY_OR_OTHER||Median Difference (Net)|-368.0||||0.007|TWO_SIDED|95.0|||||Log Rank||MVI 200 - MVI 100|Subjects who never went into active labor during the first hospitalization were censored using the longest time interval from study drug administration to delivery during the first hospitalization, independent of treatment group. Subjects who, in their first hospitalization, were discharged prior to delivery or withdraw consent prior to delivery will be censored using the longest time interval from study drug administration to labor and delivery discharge, independent of treatment group.||||0.007
71088101|NCT01548599|141682567|SUPERIORITY||Odds Ratio, log|2.028||||0.002|TWO_SIDED|95.0|0.766|3.289|||Mixed Models Analysis|||||3.289|0.766|0.002
71088102|NCT01548599|141682568|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71088103|NCT01548599|141682569|SUPERIORITY|||||||0.013|||||||Mixed Models Analysis|||||||0.013
71088104|NCT01548599|141682570|SUPERIORITY||Odds Ratio (OR)|0.261|STANDARD_ERROR_OF_MEAN|0.398||0.378|TWO_SIDED|95.0|0.013|5.165|||Mixed Models Analysis|||||5.165|0.013|0.378
71088105|NCT01548599|141682571|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71088106|NCT01548599|141682572|SUPERIORITY|||||||0.398|||||||Mixed Models Analysis|||||||0.398
71088107|NCT05630196|141682573|SUPERIORITY||Posterior Mean Difference|0.39|||||TWO_SIDED|95.0|-0.22|1.0|||||Posterior mean difference with 95% credible interval is reported.|||1.00|-0.22|
71088108|NCT05630196|141682574|SUPERIORITY||Posterior Mean Difference|1.16|||||TWO_SIDED|95.0|-0.44|2.77|||||Posterior mean difference with 95% credible interval is reported.|||2.77|-0.44|
71088109|NCT05630196|141682575|SUPERIORITY||Posterior Mean Difference|0.22|||||TWO_SIDED|95.0|-0.23|0.67|||||Posterior mean difference with 95% credible interval is reported.|||0.67|-0.23|
71088110|NCT05630196|141682576|SUPERIORITY||Posterior Mean Difference|0.52|||||TWO_SIDED|95.0|-0.13|1.18|||||Posterior mean difference with 95% credible interval is reported.|||1.18|-0.13|
71088111|NCT05630196|141682577|SUPERIORITY||Posterior Mean Difference|4.2|||||TWO_SIDED|95.0|-3.51|11.87|||||Posterior mean difference with 95% credible interval is reported.|||11.87|-3.51|
71088112|NCT05630196|141682578|SUPERIORITY||Posterior Mean Difference|-0.34|||||TWO_SIDED|95.0|-0.74|0.05|||||Posterior mean difference with 95% credible interval is reported.|||0.05|-0.74|
71088113|NCT05630196|141682579|SUPERIORITY||Posterior Mean Difference|-11.11|||||TWO_SIDED|95.0|-159.85|136.77|||||Posterior mean difference with 95% credible interval is reported.|||136.77|-159.85|
71088114|NCT05630196|141682580|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.11|0.08|||||Posterior mean difference with 95% credible interval is reported.|||0.08|-0.11|
71088115|NCT03438266|141682581|NON_INFERIORITY|If the upper limit of the confidence interval at Month 1 was less than 0.5, then treatment with cannula was considered non-inferior to treatment with needle.|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.05|0.25|||||The 95% CI is based on the paired t-test.|Change from Baseline at Month 1||0.25|-0.05|
71088116|NCT03438266|141682582|OTHER||Percentage Difference|-1.7|||||TWO_SIDED|95.0|-7.31|3.98||||||||3.98|-7.31|
71088117|NCT02308046|141682592|SUPERIORITY|||||||0.002|||||||Chi-squared, Corrected|||||||0.002
71088118|NCT02308046|141682593|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||||||<0.001
71088119|NCT02308046|141682594|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||Comparison of culture cure at 7-14 days||||<0.001
71088120|NCT02308046|141682594|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||Comparison of culture cure at 21-30 days||||<0.001
71088121|NCT02308046|141682595|SUPERIORITY|||||||0.088|||||||Chi-squared, Corrected|||Comparison of the number of subjects whose reported their symptoms completely resolved||||0.088
71088122|NCT01587885|141682598|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.548|||<|0.048|||||||Regression, Cox|||||||<0.0480
71088123|NCT00752089|141682623|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.146||||0.7756|TWO_SIDED|95.0|-6.904|9.196||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||9.196|-6.904|0.7756
70857343|NCT01931670|141200978|SUPERIORITY||Odds Ratio (OR)|2.722|||<|0.001|TWO_SIDED|97.5|1.832|4.044|||Regression, Logistic|||Month 4||4.044|1.832|< 0.001
70857344|NCT01931670|141200978|SUPERIORITY||Odds Ratio (OR)|1.537||||0.013|TWO_SIDED|97.5|1.042|2.267|||Regression, Logistic|||Month 5||2.267|1.042|0.013
70857345|NCT01931670|141200978|SUPERIORITY||Odds Ratio (OR)|2.598|||<|0.001|TWO_SIDED|97.5|1.75|3.857|||Regression, Logistic|||Month 5||3.857|1.750|< 0.001
70857346|NCT01931670|141200978|SUPERIORITY||Odds Ratio (OR)|1.565||||0.01|TWO_SIDED|97.5|1.062|2.306|||Regression, Logistic|||Month 6||2.306|1.062|0.01
70857347|NCT01931670|141200978|SUPERIORITY||Odds Ratio (OR)|2.412|||<|0.001|TWO_SIDED|97.5|1.63|3.57|||Regression, Logistic|||Month 6||3.570|1.630|< 0.001
70857348|NCT01931670|141200979|SUPERIORITY||Odds Ratio (OR)|1.028||||0.901|TWO_SIDED|97.5|0.624|1.693|||Regression, Logistic|||Month 1||1.693|0.624|0.901
70946062|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9709|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9709
70946063|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9666|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9666
70857349|NCT01931670|141200979|SUPERIORITY||Odds Ratio (OR)|1.103||||0.65|TWO_SIDED|97.5|0.68|1.789|||Regression, Logistic|||Month 1||1.789|0.680|0.65
70946064|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3204|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3204
71088124|NCT00752089|141682623|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.291||||0.4194|TWO_SIDED|95.0|-4.84|11.421||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||11.421|-4.840|0.4194
70857350|NCT01931670|141200979|SUPERIORITY||Odds Ratio (OR)|1.351||||0.154|TWO_SIDED|97.5|0.841|2.17|||Regression, Logistic|||Month 2||2.170|0.841|0.154
70857351|NCT01931670|141200979|SUPERIORITY||Odds Ratio (OR)|1.871||||0.003|TWO_SIDED|97.5|1.175|2.979|||Regression, Logistic|||Month 2||2.979|1.175|0.003
71088125|NCT00752089|141682623|SUPERIORITY_OR_OTHER||Adjusted mean difference|22.2|||<|0.0001|TWO_SIDED|95.0|14.28|30.12||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||30.120|14.280|<0.0001
70857352|NCT01931670|141200979|SUPERIORITY||Odds Ratio (OR)|1.25||||0.294|TWO_SIDED|97.5|0.776|2.013|||Regression, Logistic|||Month 3||2.013|0.776|0.294
70857353|NCT01931670|141200979|SUPERIORITY||Odds Ratio (OR)|1.865||||0.003|TWO_SIDED|97.5|1.163|2.989|||Regression, Logistic|||Month 3||2.989|1.163|0.003
70946065|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0869|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0869
70857354|NCT01931670|141200979|SUPERIORITY||Odds Ratio (OR)|1.145||||0.521|TWO_SIDED|97.5|0.713|1.839|||Regression, Logistic|||Month 4||1.839|0.713|0.521
70857355|NCT01931670|141200979|SUPERIORITY||Odds Ratio (OR)|2.474|||<|0.001|TWO_SIDED|97.5|1.544|3.963|||Regression, Logistic|||Month 4||3.963|1.544|< 0.001
70857356|NCT01931670|141200979|SUPERIORITY||Odds Ratio (OR)|1.262||||0.27|TWO_SIDED|97.5|0.787|2.023|||Regression, Logistic|||Month 5||2.023|0.787|0.27
70857357|NCT01931670|141200979|SUPERIORITY||Odds Ratio (OR)|2.416|||<|0.001|TWO_SIDED|97.5|1.5|3.891|||Regression, Logistic|||Month 5||3.891|1.500|< 0.001
70857358|NCT01931670|141200979|SUPERIORITY||Odds Ratio (OR)|1.013||||0.953|TWO_SIDED|97.5|0.631|1.624|||Regression, Logistic|||Month 6||1.624|0.631|0.953
70857359|NCT01931670|141200979|SUPERIORITY||Odds Ratio (OR)|1.997|||<|0.001|TWO_SIDED|97.5|1.253|3.183|||Regression, Logistic|||Month 6||3.183|1.253|< 0.001
70857360|NCT01931670|141200980|SUPERIORITY||LS Mean of Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.69|-0.37|||mixed-effects model|||Month 1||-0.37|-0.69|< 0.001
70857361|NCT01931670|141200980|SUPERIORITY||LS Mean of Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.94|-0.62|||mixed-effects model|||Month 1||-0.62|-0.94|< 0.001
70857362|NCT01931670|141200980|SUPERIORITY||LS Mean of Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.068|<|0.001|TWO_SIDED|97.5|-0.6|-0.29|||mixed-effects model|||Month 2||-0.29|-0.6|< 0.001
70857363|NCT01931670|141200980|SUPERIORITY||LS Mean of Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.068|<|0.001|TWO_SIDED|97.5|-1.43|-1.12|||mixed-effects model|||Month 2||-1.12|-1.43|< 0.001
70857364|NCT01931670|141200980|SUPERIORITY||LS Mean of Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.068|<|0.001|TWO_SIDED|97.5|-0.68|-0.37|||mixed-effects model|||Month 3||-0.37|-0.68|< 0.001
70857365|NCT01931670|141200980|SUPERIORITY||LS Mean of Difference|-1.25|STANDARD_ERROR_OF_MEAN|0.067|<|0.001|TWO_SIDED|97.5|-1.4|-1.09|||mixed-effects model|||Month 3||-1.09|-1.4|< 0.001
70946066|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9386|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9386
71088126|NCT00752089|141682623|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.145||||0.5927|TWO_SIDED|95.0|-5.874|10.164||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||10.164|-5.874|0.5927
71088127|NCT00752089|141682623|SUPERIORITY_OR_OTHER||Adjusted mean difference|21.054|||<|0.0001|TWO_SIDED|95.0|13.189|28.919||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||28.919|13.189|<0.0001
71088128|NCT00752089|141682623|SUPERIORITY_OR_OTHER||Adjusted mean difference|18.909|||<|0.0001|TWO_SIDED|95.0|11.036|26.783||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||26.783|11.036|<0.0001
71088129|NCT00752089|141682624|SUPERIORITY_OR_OTHER||Adjusted mean difference|-321.438||||0.199|TWO_SIDED|95.0|-818.118|175.242||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||175.242|-818.118|0.1990
71088130|NCT00752089|141682624|SUPERIORITY_OR_OTHER||Adjusted mean difference|-72.68||||0.7718||95.0|-574.398|429.039||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||429.039|-574.398|0.7718
70857366|NCT01931670|141200980|SUPERIORITY||LS Mean of Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|97.5|-0.73|-0.42|||mixed-effects model|||Month 4||-0.42|-0.73|< 0.001
70857367|NCT01931670|141200980|SUPERIORITY||LS Mean of Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|97.5|-1.42|-1.11|||mixed-effects model|||Month 4||-1.11|-1.42|< 0.001
71088131|NCT00752089|141682624|SUPERIORITY_OR_OTHER||Adjusted mean difference|1784.675|||<|0.0001||95.0|1296.044|2273.306||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||2273.306|1296.044|<0.0001
71088132|NCT00752089|141682624|SUPERIORITY_OR_OTHER||Adjusted mean difference|248.758||||0.3164||95.0|-245.962|743.478||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included tratment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||743.478|-245.962|0.3164
71088133|NCT00752089|141682624|SUPERIORITY_OR_OTHER||Adjusted mean difference|2106.113|||<|0.0001|TWO_SIDED|95.0|1620.906|2591.32||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||2591.320|1620.906|<0.0001
71088134|NCT00752089|141682624|SUPERIORITY_OR_OTHER||Adjusted mean difference|1857.355|||<|0.0001|TWO_SIDED|95.0|1371.637|2343.072||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period and fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||2343.072|1371.637|<0.0001
71088135|NCT00975416|141682642|SUPERIORITY_OR_OTHER|||||||0.927|TWO_SIDED||||||ANOVA|||Repeated measures ANOVA to deterimine whether oxytocin increased compared to placebo measures of therapeutic alliance (as measured by the Helping alliance questionnaire) pre compared to post 12 sessions of CBT.||||0.927
71088136|NCT00975416|141682642|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||ANOVA|||Repeated measures anova to determine if oxytocin compared to placebo increased therpeutic alliance as measured by the working alliance inventory after 12 sessions of CBT.||||0.60
71088137|NCT03555149|141682646|OTHER||Difference in Overall Response Rate|6.67|||||TWO_SIDED|95.0|-11.92|25.25|||||The difference in ORR was calculated as the experimental arm (Atezolizumab + Regorafenib) subtracted from the control arm (Regorafenib).|||25.25|-11.92|
71088138|NCT03555149|141682646|OTHER||Difference in Overall Response Rate|6.67|||||TWO_SIDED|95.0|-11.92|25.25|||||The difference in ORR was calculated as the experimental arm (Atezolizumab + Regorafenib + AB928) subtracted from the control arm (Regorafenib).|||25.25|-11.92|
71088139|NCT03555149|141682647|OTHER||Hazard Ratio (HR)|1.35|||||TWO_SIDED|95.0|0.67|2.73||||||||2.73|0.67|
71088140|NCT03555149|141682647|OTHER||Hazard Ratio (HR)|2.3|||||TWO_SIDED|95.0|1.08|4.88||||||||4.88|1.08|
71088141|NCT03555149|141682647|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.29|2.18||||||||2.18|0.29|
71088142|NCT03555149|141682647|OTHER||Hazard Ratio (HR)|2.0|||||TWO_SIDED|95.0|0.64|6.24||||||||6.24|0.64|
71088143|NCT03555149|141682647|OTHER||Hazard Ratio (HR)|1.74|||||TWO_SIDED|95.0|0.83|3.63||||||||3.63|0.83|
71088144|NCT03555149|141682647|OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.39|1.63||||||||1.63|0.39|
71088145|NCT03555149|141682647|OTHER||Hazard Ratio (HR)|5.64|||||TWO_SIDED|95.0|0.94|33.82||||||||33.82|0.94|
70946067|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4352|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4352
71088146|NCT03555149|141682648|OTHER|Kaplan-Meier|Hazard Ratio (HR)|1.44|||||TWO_SIDED|95.0|0.71|2.93||||||Atezolizumab + Imprime PGG + Bevacizumab vs. Regorafenib (Control) Hazard Ratio for OS||2.93|0.71|
71088147|NCT03555149|141682648|OTHER|Kaplan-Meier|Hazard Ratio (HR)|1.38|||||TWO_SIDED|95.0|0.68|2.81||||||Atezolizumab + Isatuximab vs. Regorafenib (Control) Hazard Ratio for OS||2.81|0.68|
71088148|NCT03555149|141682648|OTHER|Kaplan-Meier|Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.3|2.72||||||Atezolizumab + Selicrelumab + Bevacizumab vs. Regorafenib (Control) Hazard Ratio for OS||2.72|0.30|
71088149|NCT03555149|141682648|OTHER|Kaplan-Meier|Hazard Ratio (HR)|1.27|||||TWO_SIDED|95.0|0.42|3.84||||||Atezolizumab + Idasanutlin vs. Regorafenib (Control) Hazard Ratio for OS||3.84|0.42|
71088150|NCT03555149|141682648|OTHER|Kaplan-Meier|Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.39|1.88||||||Atezolizumab + Regorafenib vs. Regorafenib (Control) Hazard Ratio for OS||1.88|0.39|
71088151|NCT03555149|141682648|OTHER|Kaplan-Meier|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.43|1.96||||||Atezolizumab + Regorafenib + AB928 vs. Regorafenib (Control) Hazard Ratio for OS||1.96|0.43|
70857368|NCT01931670|141200980|SUPERIORITY||LS Mean of Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.65|-0.33|||mixed-effects model|||Month 5||-0.33|-0.65|< 0.001
71088152|NCT03555149|141682648|OTHER|Kaplan-Meier|Hazard Ratio (HR)|2.88|||||TWO_SIDED|95.0|0.33|24.85||||||Atezolizumab + LOAd703 vs. Regorafenib (Control) Hazard Ratio for OS||24.85|0.33|
71088153|NCT03555149|141682649|OTHER||Difference in OS Event-Free Rate|15.79|||||TWO_SIDED|95.0|-0.61|32.19||||||Difference in OS event-free rate at 3 months for the Atezolizumab + Imprime PGG + Bevacizumab vs. Regorafenib (Control) arms||32.19|-0.61|
71088154|NCT03555149|141682649|OTHER||Difference in OS Event-Free Rate|-16.49|||||TWO_SIDED|95.0|-49.78|16.79||||||Difference in OS event-free rate at 6 months for the Atezolizumab + Imprime PGG + Bevacizumab vs. Regorafenib (Control) arms||16.79|-49.78|
71125758|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||60.07|TWO_SIDED|95.0|0.66|1.39||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.39|0.66|60.07
70857369|NCT01931670|141200980|SUPERIORITY||LS Mean of Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-1.42|-1.1|||mixed-effects model|||Month 5||-1.10|-1.42|< 0.001
70857370|NCT01931670|141200981|SUPERIORITY||LS Mean of Difference|-25.31|STANDARD_ERROR_OF_MEAN|3.669|<|0.001|TWO_SIDED|97.5|-33.55|-17.07|||mixed-effects model|||Month 1||-17.07|-33.55|< 0.001
71088155|NCT03555149|141682649|OTHER||Difference in OS Event-Free Rate|-14.45|||||TWO_SIDED|95.0|-44.37|15.47||||||Difference in OS event-free rate at 12 months for the Atezolizumab + Imprime PGG + Bevacizumab vs. Regorafenib (Control) arms||15.47|-44.37|
71088156|NCT03555149|141682649|OTHER||Difference in OS Event-Free Rate|-10.56|||||TWO_SIDED|95.0|-32.25|11.14||||||Difference in OS event-free rate at 18 months for the Atezolizumab + Imprime PGG + Bevacizumab vs. Regorafenib (Control) arms||11.14|-32.25|
71088157|NCT03555149|141682649|OTHER||Difference in OS Event-Free Rate|-10.88|||||TWO_SIDED|95.0|-38.62|16.87||||||Difference in OS event-free rate at 3 months for the Atezolizumab + Isatuximab vs. Regorafenib (Control) arms||16.87|-38.62|
71088158|NCT03555149|141682649|OTHER||Difference in OS Event-Free Rate|-23.16|||||TWO_SIDED|95.0|-56.1|9.78||||||Difference in OS event-free rate at 6 months for the Atezolizumab + Isatuximab vs. Regorafenib (Control) arms||9.78|-56.10|
71088159|NCT03555149|141682649|OTHER||Difference in OS Event-Free Rate|-7.78|||||TWO_SIDED|95.0|-39.19|23.62||||||Difference in OS event-free rate at 12 months for the Atezolizumab + Isatuximab vs. Regorafenib (Control) arms||23.62|-39.19|
71088160|NCT03555149|141682649|OTHER||Difference in OS Event-Free Rate|2.78|||||TWO_SIDED|95.0|-24.08|29.63||||||Difference in OS event-free rate at 18 months for the Atezolizumab + Isatuximab vs. Regorafenib (Control) arms||29.63|-24.08|
71088161|NCT03555149|141682649|OTHER||Difference in OS Event-Free Rate|15.79|||||TWO_SIDED|95.0|-0.61|32.19||||||Difference in OS event-free rate at 3 months for the Atezolizumab + Selicrelumab + Bevacizumab vs. Regorafenib (Control) arms||32.19|-0.61|
71088162|NCT03555149|141682649|OTHER||Difference in OS Event-Free Rate|16.84|||||TWO_SIDED|95.0|-24.39|58.07||||||Difference in OS event-free rate at 6 months for the Atezolizumab + Selicrelumab + Bevacizumab vs. Regorafenib (Control) arms||58.07|-24.39|
71088163|NCT03555149|141682649|OTHER||Difference in OS Event-Free Rate|18.88|||||TWO_SIDED|95.0|-34.53|72.3||||||Difference in OS event-free rate at 12 months for the Atezolizumab + Selicrelumab + Bevacizumab vs. Regorafenib (Control) arms||72.30|-34.53|
71088164|NCT03555149|141682649|OTHER||Difference in OS Event-Free Rate|9.44|||||TWO_SIDED|95.0|-38.19|57.08||||||Difference in OS event-free rate at 18 months for the Atezolizumab + Selicrelumab + Bevacizumab vs. Regorafenib (Control) arms||57.08|-38.19|
71088165|NCT03555149|141682649|OTHER||Difference in OS Event-Free Rate|-9.21|||||TWO_SIDED|95.0|-54.7|36.28||||||Difference in OS event-free rate at 3 months for the Atezolizumab + Idasanutlin vs. Regorafenib (Control) arms||36.28|-54.70|
71088166|NCT03555149|141682649|OTHER||Difference in OS Event-Free Rate|-13.16|||||TWO_SIDED|95.0|-66.74|40.43||||||Difference in OS event-free rate at 6 months for the Atezolizumab + Idasanutlin vs. Regorafenib (Control) arms||40.43|-66.74|
71088167|NCT03555149|141682649|OTHER||Difference in OS Event-Free Rate|-9.45|||||TWO_SIDED|95.0|-57.26|38.36||||||Difference in OS event-free rate at 12 months for the Atezolizumab + Idasanutlin vs. Regorafenib (Control) arms||38.36|-57.26|
71088168|NCT03555149|141682649|OTHER||Difference in OS Event-Free Rate|7.78|||||TWO_SIDED|95.0|-38.18|53.73||||||Difference in OS event-free rate at 18 months for the Atezolizumab + Idasanutlin vs. Regorafenib (Control) arms||53.73|-38.18|
71088169|NCT03555149|141682649|OTHER||Difference in OS Event-Free Rate|-5.24|||||TWO_SIDED|95.0|-32.03|21.56||||||Difference in OS event-free rate at 3 months for the Atezolizumab + Regorafenib vs. Regorafenib (Control) arms||21.56|-32.03|
71088170|NCT03555149|141682649|OTHER||Difference in OS Event-Free Rate|8.64|||||TWO_SIDED|95.0|-23.33|40.6||||||Difference in OS event-free rate at 6 months for the Atezolizumab + Regorafenib vs. Regorafenib (Control) arms||40.60|-23.33|
71088171|NCT03555149|141682649|OTHER||Difference in OS Event-Free Rate|5.44|||||TWO_SIDED|95.0|-29.19|40.06||||||Difference in OS event-free rate at 12 months for the Atezolizumab + Regorafenib vs. Regorafenib (Control) arms||40.06|-29.19|
71088172|NCT03555149|141682649|OTHER||Difference in OS Event-Free Rate|6.71|||||TWO_SIDED|95.0|-22.64|36.06||||||Difference in OS event-free rate at 18 months for the Atezolizumab + Regorafenib vs. Regorafenib (Control) arms||36.06|-22.64|
71088173|NCT03555149|141682649|OTHER||Difference in OS Event-Free Rate|2.46|||||TWO_SIDED|95.0|-21.31|26.22||||||Difference in OS event-free rate at 3 months for the Atezolizumab + Regorafenib + AB928 vs. Regorafenib (Control) arms||26.22|-21.31|
71088174|NCT03555149|141682649|OTHER||Difference in OS Event-Free Rate|10.18|||||TWO_SIDED|95.0|-20.99|41.34||||||Difference in OS event-free rate at 6 months for the Atezolizumab + Regorafenib + AB928 vs. Regorafenib (Control) arms||41.34|-20.99|
71088175|NCT03555149|141682649|OTHER||Difference in OS Event-Free Rate|-1.12|||||TWO_SIDED|95.0|-33.59|31.36||||||Difference in OS event-free rate at 12 months for the Atezolizumab + Regorafenib + AB928 vs. Regorafenib (Control) arms||31.36|-33.59|
71088176|NCT03555149|141682649|OTHER||Difference in OS Event-Free Rate|9.44|||||TWO_SIDED|95.0|-19.06|37.94||||||Difference in OS event-free rate at 18 months for the Atezolizumab + Regorafenib + AB928 vs. Regorafenib (Control) arms||37.94|-19.06|
71088177|NCT03555149|141682649|OTHER||Difference in OS Event-Free Rate|15.79|||||TWO_SIDED|95.0|-0.61|32.19||||||Difference in OS event-free rate at 3 months for the Atezolizumab +LOAd703 vs. Regorafenib (Control) arms||32.19|-0.61|
71088178|NCT03863353|141682654|SUPERIORITY||Rebression coefficient|2.13||||0.001|TWO_SIDED|95.0|0.86|3.4||Adjusted for repeated measures and effects of covariates|Regression, Linear|||Hypothesis was tested using multivariable regression models (generalized estimating equation)||3.40|0.86|.001
71088179|NCT03863353|141682655|SUPERIORITY||Odds Ratio (OR)|1.17||||0.534|TWO_SIDED|95.0|0.72|1.9||adjusted for covariates|Regression, Logistic|||Logistic regression model examined the effect of the intervention on the outcome (collapsed intentions/behaviors)||1.90|0.72|0.534
71088180|NCT00323063|141682675|OTHER|||||||0.3|||||||Log Rank|||||||0.3
71088181|NCT01614470|141682730|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|10.678|||<|0.0001|TWO_SIDED|95.0|7.2559|14.1|||Mixed Models Analysis|||||14.1000|7.2559|<0.0001
71088182|NCT01614470|141682731|SUPERIORITY_OR_OTHER||LS mean difference|0.6624|||<|0.0001|TWO_SIDED|95.0|0.3366|0.9881|||Mixed Models Analysis|||||0.9881|0.3366|<0.0001
71088183|NCT01614470|141682733|SUPERIORITY_OR_OTHER||LS mean difference|-49.1667|||<|0.0001|TWO_SIDED|95.0|-56.9527|-41.3807|||Mixed Models Analysis|||||-41.3807|-56.9527|<0.0001
71088184|NCT01614470|141682736|SUPERIORITY_OR_OTHER||LS mean difference|9.6105||||0.0004|TWO_SIDED|95.0|4.4874|14.7336|||Mixed Models Analysis|||||14.7336|4.4874|0.0004
71088185|NCT02175121|141682744|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-40.33|STANDARD_ERROR_OF_MEAN|6.75|<|0.0001|TWO_SIDED|90.0|-51.49|-29.16||Two-sided p-values are from analysis of Covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values is derived from the ANCOVA model.||Placebo was the Reference and each of the active doses was the Test.||-29.16|-51.49|<0.0001
71088186|NCT02175121|141682744|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-45.53|STANDARD_ERROR_OF_MEAN|6.98|<|0.0001|TWO_SIDED|90.0|-57.08|-33.99||Two-sided p-values are from analysis of Covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values is derived from the ANCOVA model.||Placebo was the Reference and each of the active doses was the Test.||-33.99|-57.08|<0.0001
71088187|NCT02175121|141682744|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-68.79|STANDARD_ERROR_OF_MEAN|6.73|<|0.0001|TWO_SIDED|90.0|-79.92|-57.65||Two-sided p-values are from analysis of Covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values is derived from the ANCOVA model.||Placebo was the Reference and each of the active doses was the Test.||-57.65|-79.92|<0.0001
71088188|NCT02175121|141682744|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-68.12|STANDARD_ERROR_OF_MEAN|6.86|<|0.0001|TWO_SIDED|90.0|-79.46|-56.78||Two-sided p-values are from analysis of Covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values is derived from the ANCOVA model.||Placebo was the Reference and each of the active doses was the Test.||-56.78|-79.46|<0.0001
71088189|NCT02175121|141682745|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.25|STANDARD_ERROR_OF_MEAN|5.83||0.006|TWO_SIDED|90.0|-25.9|-6.6||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||-6.60|-25.90|0.0060
70857371|NCT01931670|141200981|SUPERIORITY||LS Mean of Difference|-39.32|STANDARD_ERROR_OF_MEAN|3.657|<|0.001|TWO_SIDED|97.5|-47.53|-31.11|||mixed-effects model|||Month 1||-31.11|-47.53|< 0.001
70857372|NCT01931670|141200981|SUPERIORITY||LS Mean of Difference|-21.9|STANDARD_ERROR_OF_MEAN|3.355|<|0.001|TWO_SIDED|97.5|-29.44|-14.36|||mixed-effects model|||Month 2||-14.36|-29.44|< 0.001
70857373|NCT01931670|141200981|SUPERIORITY||LS Mean of Difference|-63.31|STANDARD_ERROR_OF_MEAN|3.365|<|0.001|TWO_SIDED|97.5|-70.87|-55.76|||mixed-effects model|||Month 2||-55.76|-70.87|< 0.001
71088190|NCT02175121|141682745|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.98|STANDARD_ERROR_OF_MEAN|5.94|<|0.0001|TWO_SIDED|90.0|-36.81|-17.15||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||-17.15|-36.81|<0.0001
71088191|NCT02175121|141682745|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-39.6|STANDARD_ERROR_OF_MEAN|5.8|<|0.0001|TWO_SIDED|90.0|-49.2|-30.0||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||-30.00|-49.20|<0.0001
70857374|NCT01931670|141200981|SUPERIORITY||LS Mean of Difference|-25.15|STANDARD_ERROR_OF_MEAN|3.241|<|0.001|TWO_SIDED|97.5|-32.43|-17.88|||mixed-effects model|||Month 3||-17.88|-32.43|< 0.001
70857375|NCT01931670|141200981|SUPERIORITY||LS Mean of Difference|-61.94|STANDARD_ERROR_OF_MEAN|3.233|<|0.001|TWO_SIDED|97.5|-69.2|-54.68|||mixed-effects model|||Month 3||-54.68|-69.20|< 0.001
70857376|NCT01931670|141200981|SUPERIORITY||LS Mean of Difference|-26.97|STANDARD_ERROR_OF_MEAN|3.344|<|0.001|TWO_SIDED|97.5|-34.48|-19.46|||mixed-effects model|||Month 4||-19.46|-34.48|< 0.001
71088192|NCT02175121|141682745|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-46.72|STANDARD_ERROR_OF_MEAN|5.89|<|0.0001|TWO_SIDED|90.0|-56.46|-36.98||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||-36.98|-56.46|<0.0001
71088193|NCT02175121|141682745|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-27.07|STANDARD_ERROR_OF_MEAN|5.33|<|0.0001|TWO_SIDED|90.0|-35.89|-18.25||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||-18.25|-35.89|<0.0001
70857377|NCT01931670|141200981|SUPERIORITY||LS Mean of Difference|-62.37|STANDARD_ERROR_OF_MEAN|3.346|<|0.001|TWO_SIDED|97.5|-69.89|-54.86|||mixed-effects model|||Month 4||-54.86|-69.89|< 0.001
70857378|NCT01931670|141200981|SUPERIORITY||LS Mean of Difference|-23.36|STANDARD_ERROR_OF_MEAN|3.428|<|0.001|TWO_SIDED|97.5|-31.06|-15.66|||mixed-effects model|||Month 5||-15.66|-31.06|< 0.001
70857379|NCT01931670|141200981|SUPERIORITY||LS Mean of Difference|-62.9|STANDARD_ERROR_OF_MEAN|3.42|<|0.001|TWO_SIDED|97.5|-70.58|-55.22|||mixed-effects model|||Month 5||-55.22|-70.58|< 0.001
70857380|NCT01931670|141200981|SUPERIORITY||LS Mean of Difference|-25.89|STANDARD_ERROR_OF_MEAN|3.528|<|0.001|TWO_SIDED|97.5|-33.81|-17.97|||mixed-effects model|||Month 6||-17.97|-33.81|< 0.001
70857381|NCT01931670|141200981|SUPERIORITY||LS Mean of Difference|-56.62|STANDARD_ERROR_OF_MEAN|3.522|<|0.001|TWO_SIDED|97.5|-64.53|-48.7|||mixed-effects model|||Month 6||-48.70|-64.53|< 0.001
70857382|NCT01931670|141200982|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.549|TWO_SIDED|97.5|-0.11|0.07|||mixed-effects model|||Month 1||0.07|-0.11|0.549
70857383|NCT01931670|141200982|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.04||0.02|TWO_SIDED|97.5|-0.18|0.0|||mixed-effects model|||Month 1||0.00|-0.18|0.02
70857384|NCT01931670|141200982|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.044||0.11|TWO_SIDED|97.5|-0.17|0.03|||mixed-effects model|||Month 2||0.03|-0.17|0.11
70857385|NCT01931670|141200982|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.043|<|0.001|TWO_SIDED|97.5|-0.3|-0.11|||mixed-effects model|||Month 2||-0.11|-0.30|< 0.001
70857386|NCT01931670|141200982|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.05||0.041|TWO_SIDED|97.5|-0.22|0.01|||mixed-effects model|||Month 3||0.01|-0.22|0.041
70857387|NCT01931670|141200982|SUPERIORITY||LS Mean of Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|97.5|-0.41|-0.18|||mixed-effects model|||Month 3||-0.18|-0.41|< 0.001
70857388|NCT01931670|141200982|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.052||0.081|TWO_SIDED|97.5|-0.21|0.03|||mixed-effects model|||Month 4||0.03|-0.21|0.081
70857389|NCT01931670|141200982|SUPERIORITY||LS Mean of Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.052|<|0.001|TWO_SIDED|97.5|-0.45|-0.22|||mixed-effects model|||Month 4||-0.22|-0.45|<0.001
71125759|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||51.75|TWO_SIDED|95.0|0.65|1.53||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.53|0.65|51.75
71125760|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||65.66|TWO_SIDED|95.0|0.6|1.4||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.40|0.60|65.66
71125761|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.85||||81.67|TWO_SIDED|95.0|0.59|1.21||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.21|0.59|81.67
71125762|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.77||||89.98|TWO_SIDED|95.0|0.51|1.15||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.15|0.51|89.98
71125763|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||43.88|TWO_SIDED|95.0|0.7|1.51||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.51|0.70|43.88
71125764|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.1||||36.1|TWO_SIDED|95.0|0.64|1.91||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.91|0.64|36.10
71125765|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.7||||95.74|TWO_SIDED|95.0|0.47|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.47|95.74
70857390|NCT01931670|141200982|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.054||0.062|TWO_SIDED|97.5|-0.22|0.02|||mixed-effects model|||Month 5||0.02|-0.22|0.062
70857391|NCT01931670|141200982|SUPERIORITY||LS Mean of Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.054|<|0.001|TWO_SIDED|97.5|-0.46|-0.22|||mixed-effects model|||Month 5||-0.22|-0.46|< 0.001
70857392|NCT01931670|141200983|SUPERIORITY||LS Mean of Difference|-3.04|STANDARD_ERROR_OF_MEAN|2.94||0.301|TWO_SIDED|97.5|-9.64|3.56|||mixed-effects model|||Month 1||3.56|-9.64|0.301
70857393|NCT01931670|141200983|SUPERIORITY||LS Mean of Difference|-6.43|STANDARD_ERROR_OF_MEAN|2.92||0.028|TWO_SIDED|97.5|-12.99|0.13|||mixed-effects model|||Month 1||0.13|-12.99|0.028
70857394|NCT01931670|141200983|SUPERIORITY||LS Mean of Difference|-5.17|STANDARD_ERROR_OF_MEAN|2.964||0.082|TWO_SIDED|97.5|-11.82|1.49|||mixed-effects model|||Month 2||1.49|-11.82|0.082
70857395|NCT01931670|141200983|SUPERIORITY||LS Mean of Difference|-13.19|STANDARD_ERROR_OF_MEAN|2.956|<|0.001|TWO_SIDED|97.5|-19.83|-6.55|||mixed-effects model|||Month 2||-6.55|-19.83|< 0.001
70857396|NCT01931670|141200983|SUPERIORITY||LS Mean of Difference|-6.84|STANDARD_ERROR_OF_MEAN|3.379||0.043|TWO_SIDED|97.5|-14.43|0.75|||mixed-effects model|||Month 3||0.75|-14.43|0.043
70857397|NCT01931670|141200983|SUPERIORITY||LS Mean of Difference|-19.05|STANDARD_ERROR_OF_MEAN|3.364|<|0.001|TWO_SIDED|97.5|-26.61|-11.49|||mixed-effects model|||Month 3||-11.49|-26.61|< 0.001
70946068|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4522|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4522
71088194|NCT02175121|141682745|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-36.18|STANDARD_ERROR_OF_MEAN|5.46|<|0.0001|TWO_SIDED|90.0|-45.21|-27.14||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||-27.14|-45.21|<0.0001
71088195|NCT02175121|141682745|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-51.47|STANDARD_ERROR_OF_MEAN|5.33|<|0.0001|TWO_SIDED|90.0|-60.29|-42.65||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||-42.65|-60.29|<0.0001
71088196|NCT02175121|141682745|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-57.17|STANDARD_ERROR_OF_MEAN|5.41|<|0.0001|TWO_SIDED|90.0|-66.12|-48.22||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||-48.22|-66.12|<0.0001
71088197|NCT02175121|141682746|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.86|STANDARD_ERROR_OF_MEAN|10.13||0.2063|TWO_SIDED|90.0|-3.91|29.62||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||29.62|-3.91|0.2063
71088198|NCT02175121|141682746|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.03|STANDARD_ERROR_OF_MEAN|10.33||0.2087|TWO_SIDED|90.0|-4.05|30.11||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||30.11|-4.05|0.2087
71088199|NCT02175121|141682746|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.6|STANDARD_ERROR_OF_MEAN|10.1||0.5802|TWO_SIDED|90.0|-11.11|22.3||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||22.30|-11.11|0.5802
71088200|NCT02175121|141682746|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.64|STANDARD_ERROR_OF_MEAN|10.25||0.1553|TWO_SIDED|90.0|-2.32|31.59||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||31.59|-2.32|0.1553
71088201|NCT02175121|141682746|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2|STANDARD_ERROR_OF_MEAN|7.66||0.7741|TWO_SIDED|90.0|-14.87|10.47||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||10.47|-14.87|0.7741
71088202|NCT02175121|141682746|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|7.78||0.9588|TWO_SIDED|90.0|-13.28|12.47||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||12.47|-13.28|0.9588
71088203|NCT02175121|141682746|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.42|STANDARD_ERROR_OF_MEAN|7.61||0.8523|TWO_SIDED|90.0|-11.17|14.01||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||14.01|-11.17|0.8523
71088204|NCT02175121|141682746|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.3|STANDARD_ERROR_OF_MEAN|7.73||0.4166|TWO_SIDED|90.0|-6.49|19.08||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||19.08|-6.49|0.4166
71088205|NCT02175121|141682747|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|3.22||0.8516|TWO_SIDED|90.0|-4.73|5.93||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||5.93|-4.73|0.8516
71088206|NCT02175121|141682747|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.97|STANDARD_ERROR_OF_MEAN|3.29||0.2303|TWO_SIDED|90.0|-1.48|9.42||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||9.42|-1.48|0.2303
71088207|NCT02175121|141682747|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.19|STANDARD_ERROR_OF_MEAN|3.22||0.7132|TWO_SIDED|90.0|-4.15|6.52||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||6.52|-4.15|0.7132
70857398|NCT01931670|141200983|SUPERIORITY||LS Mean of Difference|-6.25|STANDARD_ERROR_OF_MEAN|3.473||0.072|TWO_SIDED|97.5|-14.05|1.55|||mixed-effects model|||Month 4||1.55|-14.05|0.072
70857399|NCT01931670|141200983|SUPERIORITY||LS Mean of Difference|-21.58|STANDARD_ERROR_OF_MEAN|3.46|<|0.001|TWO_SIDED|97.5|-29.35|-13.81|||mixed-effects model|||Month 4||-13.81|-29.35|< 0.001
70946069|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6606|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6606
71125766|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||50.74|TWO_SIDED|95.0|0.67|1.48||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.48|0.67|50.74
71125767|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.85||||72.81|TWO_SIDED|95.0|0.51|1.44||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.44|0.51|72.81
71125768|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.73||||94.41|TWO_SIDED|95.0|0.5|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.50|94.41
71125769|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.83||||81.07|TWO_SIDED|95.0|0.55|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.25|0.55|81.07
71125770|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.87||||69.29|TWO_SIDED|95.0|0.5|1.51||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.51|0.50|69.29
71125771|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.86||||73.67|TWO_SIDED|95.0|0.54|1.37||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.37|0.54|73.67
71125772|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.87||||75.82|TWO_SIDED|95.0|0.59|1.29||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.29|0.59|75.82
71125773|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||54.22|TWO_SIDED|95.0|0.69|1.39||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.39|0.69|54.22
71125774|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||66.46|TWO_SIDED|95.0|0.63|1.35||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.35|0.63|66.46
71125775|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.16||||21.45|TWO_SIDED|95.0|0.79|1.71||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Upper; D12D28 . The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.71|0.79|21.45
71125776|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.86||||69.91|TWO_SIDED|95.0|0.5|1.5||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.50|0.50|69.91
70857400|NCT01931670|141200983|SUPERIORITY||LS Mean of Difference|-6.21|STANDARD_ERROR_OF_MEAN|3.536||0.08|TWO_SIDED|97.5|-14.15|1.73|||mixed-effects model|||Month 5||1.73|-14.15|0.08
70857401|NCT01931670|141200983|SUPERIORITY||LS Mean of Difference|-21.66|STANDARD_ERROR_OF_MEAN|3.52|<|0.001|TWO_SIDED|97.5|-29.56|-13.75|||mixed-effects model|||Month 5||-13.75|-29.56|< 0.001
70857402|NCT01931670|141200983|SUPERIORITY||LS Mean of Difference|-10.83|STANDARD_ERROR_OF_MEAN|3.744||0.004|TWO_SIDED|97.5|-19.24|-2.43|||mixed-effects model|||Month 6||-2.43|-19.24|0.004
70857403|NCT01931670|141200983|SUPERIORITY||LS Mean of Difference|-21.16|STANDARD_ERROR_OF_MEAN|3.729|<|0.001|TWO_SIDED|97.5|-29.54|-12.79|||mixed-effects model|||Month 6||-12.79|-29.54|< 0.001
70857404|NCT01931670|141200984|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.059||0.688|TWO_SIDED|97.5|-0.11|0.16|||mixed-effects model|||Month 1||0.16|-0.11|0.688
70857405|NCT01931670|141200984|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.058||0.431|TWO_SIDED|97.5|-0.18|0.08|||mixed-effects model|||Month 1||0.08|-0.18|0.431
70857406|NCT01931670|141200984|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.06||0.277|TWO_SIDED|97.5|-0.2|0.07|||mixed-effects model|||Month 2||0.07|-0.20|0.277
70946070|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1733|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1733
71088208|NCT02175121|141682747|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.74|STANDARD_ERROR_OF_MEAN|3.28||0.0034|TWO_SIDED|90.0|4.32|15.16||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||15.16|4.32|0.0034
71088209|NCT02175121|141682747|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.99|STANDARD_ERROR_OF_MEAN|2.96||0.7394|TWO_SIDED|90.0|-5.89|3.92||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||3.92|-5.89|0.7394
71088210|NCT02175121|141682747|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.52|STANDARD_ERROR_OF_MEAN|3.03||0.8652|TWO_SIDED|90.0|-4.5|5.53||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||5.53|-4.50|0.8652
71088211|NCT02175121|141682747|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.61|STANDARD_ERROR_OF_MEAN|2.97||0.837|TWO_SIDED|90.0|-4.3|5.52||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||5.52|-4.30|0.8370
71088212|NCT02175121|141682747|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.59|STANDARD_ERROR_OF_MEAN|3.01||0.0018|TWO_SIDED|90.0|4.6|14.58||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||14.58|4.60|0.0018
71088213|NCT02175121|141682748|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.12|STANDARD_ERROR_OF_MEAN|4.25||0.6182|TWO_SIDED|90.0|-9.15|4.91||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||4.91|-9.15|0.6182
71088214|NCT02175121|141682748|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.66|STANDARD_ERROR_OF_MEAN|4.34||0.7028|TWO_SIDED|90.0|-5.52|8.84||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||8.84|-5.52|0.7028
71088215|NCT02175121|141682748|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|4.25||0.9445|TWO_SIDED|90.0|-7.33|6.73||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||6.73|-7.33|0.9445
71088216|NCT02175121|141682748|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.07|STANDARD_ERROR_OF_MEAN|4.32||0.0373|TWO_SIDED|90.0|1.93|16.21||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||16.21|1.93|0.0373
71088217|NCT02175121|141682748|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|4.21||0.9448|TWO_SIDED|90.0|-7.25|6.67||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||6.67|-7.25|0.9448
70857407|NCT01931670|141200984|SUPERIORITY||LS Mean of Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|97.5|-0.37|-0.1|||mixed-effects model|||Month 2||-0.10|-0.37|< 0.001
70857408|NCT01931670|141200984|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.071||0.494|TWO_SIDED|97.5|-0.21|0.11|||mixed-effects model|||Month 4||0.11|-0.21|0.494
70857409|NCT01931670|141200984|SUPERIORITY||LS Mean of Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.43|-0.11|||mixed-effects model|||Month 4||-0.11|-0.43|< 0.001
70857410|NCT01931670|141200984|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.072||0.765|TWO_SIDED|97.5|-0.18|0.14|||mixed-effects model|||Month 5||0.14|-0.18|0.765
70857411|NCT01931670|141200984|SUPERIORITY||LS Mean of Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.073|<|0.001|TWO_SIDED|97.5|-0.47|-0.15|||mixed-effects model|||Month 5||-0.15|-0.47|< 0.001
70857412|NCT01931670|141200984|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_DEVIATION|0.076||0.468|TWO_SIDED|97.5|-0.23|0.12|||mixed-effects model|||Month 6||0.12|-0.23|0.468
70857413|NCT01931670|141200984|SUPERIORITY||LS Mean of Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.076|<|0.001|TWO_SIDED|97.5|-0.5|-0.16|||mixed-effects model|||Month 6||-0.16|-0.50|< 0.001
70857414|NCT01931670|141200985|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.04||0.029|TWO_SIDED|97.5|-0.18|0.0|||mixed-effects model|||Month 1||0.00|-0.18|0.029
71125777|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.86||||75.29|TWO_SIDED|95.0|0.57|1.31||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.31|0.57|75.29
71125778|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||44.05|TWO_SIDED|95.0|0.68|1.58||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.58|0.68|44.05
71125779|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.82||||94.93|TWO_SIDED|95.0|0.65|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region; Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.65|94.93
71125780|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.77||||97.11|TWO_SIDED|95.0|0.59|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.59|97.11
71125781|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||85.41|TWO_SIDED|95.0|0.7|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.70|85.41
71125782|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||54.73|TWO_SIDED|95.0|0.62|1.53||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.53|0.62|54.73
71125783|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||72.31|TWO_SIDED|95.0|0.61|1.3||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.30|0.61|72.31
71125784|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.21||||15.05|TWO_SIDED|95.0|0.84|1.75||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.75|0.84|15.05
71125785|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.88||||84.87|TWO_SIDED|95.0|0.68|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.68|84.87
70857415|NCT01931670|141200985|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.039||0.004|TWO_SIDED|97.5|-0.2|-0.03|||mixed-effects model|||Month 1||-0.03|-0.20|0.004
71125786|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.82||||92.24|TWO_SIDED|95.0|0.63|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.63|92.24
70857416|NCT01931670|141200985|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.042||0.076|TWO_SIDED|97.5|-0.17|0.02|||mixed-effects model|||Month 2||0.02|-0.17|0.076
70857417|NCT01931670|141200985|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.042|<|0.001|TWO_SIDED|97.5|-0.28|-0.09|||mixed-effects model|||Month 2||-0.09|-0.28|< 0.001
70857418|NCT01931670|141200985|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.045||0.058|TWO_SIDED|97.5|-0.19|0.02|||mixed-effects model|||Month 4||0.02|-0.19|0.058
70857419|NCT01931670|141200985|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.045|<|0.001|TWO_SIDED|97.5|-0.32|-0.12|||mixed-effects model|||Month 4||-0.12|-0.32|< 0.001
71088218|NCT02175121|141682748|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|4.3||0.9312|TWO_SIDED|90.0|-6.74|7.49||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||7.49|-6.74|0.9312
71125787|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||63.42|TWO_SIDED|95.0|0.75|1.22||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.22|0.75|63.42
70857420|NCT01931670|141200985|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.049||0.284|TWO_SIDED|97.5|-0.16|0.06|||mixed-effects model|||Month 5||0.06|-0.16|0.284
71125788|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.17||||9.05|TWO_SIDED|95.0|0.93|1.46||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.46|0.93|9.05
70946071|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8788|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8788
71125789|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||66.4|TWO_SIDED|95.0|0.74|1.22||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.22|0.74|66.40
71125790|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.78||||97.39|TWO_SIDED|95.0|0.6|1.0||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.00|0.60|97.39
71125791|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.13||||16.02|TWO_SIDED|95.0|0.89|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.42|0.89|16.02
71125792|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.9||||75.69|TWO_SIDED|95.0|0.68|1.21||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.21|0.68|75.69
71125793|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.86||||90.22|TWO_SIDED|95.0|0.69|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.69|90.22
71125794|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.21||||9.64|TWO_SIDED|95.0|0.91|1.62||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.62|0.91|9.64
71125795|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.15||||20.44|TWO_SIDED|95.0|0.82|1.61||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.61|0.82|20.44
70857421|NCT01931670|141200985|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.048|<|0.001|TWO_SIDED|97.5|-0.33|-0.11|||mixed-effects model|||Month 5||-0.11|-0.33|< 0.001
70857422|NCT01931670|141200986|SUPERIORITY||LS Mean of Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.56|-0.18|||ANOVA|||Month 1||-0.18|-0.56|< 0.001
70857423|NCT01931670|141200986|SUPERIORITY||LS Mean of Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.84|-0.46|||ANOVA|||Month 1||-0.46|-0.84|< 0.001
70946072|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8474|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8474
71125796|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||55.06|TWO_SIDED|95.0|0.73|1.31||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.31|0.73|55.06
71125797|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.36||||5.29|TWO_SIDED|95.0|0.94|1.97||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.97|0.94|5.29
71125798|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.11||||28.82|TWO_SIDED|95.0|0.77|1.6||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.60|0.77|28.82
71125799|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.81||||93|TWO_SIDED|95.0|0.61|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.61|93.00
71125800|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.42||||1.64|TWO_SIDED|95.0|1.03|1.95||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.95|1.03|1.64
71125801|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||50.71|TWO_SIDED|95.0|0.72|1.38||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.38|0.72|50.71
71125802|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.68||||99.52|TWO_SIDED|95.0|0.51|0.91||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.91|0.51|99.52
71125803|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.22||||3.1|TWO_SIDED|95.0|0.99|1.51||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.51|0.99|3.10
71125804|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||75.39|TWO_SIDED|95.0|0.71|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.18|0.71|75.39
70946073|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2938|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2938
71125805|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.85||||93.29|TWO_SIDED|95.0|0.68|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.68|93.29
71125806|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.33||||3.79|TWO_SIDED|95.0|0.97|1.82||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.82|0.97|3.79
71125807|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||36.75|TWO_SIDED|95.0|0.76|1.48||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.48|0.76|36.75
70857424|NCT01931670|141200986|SUPERIORITY||LS Mean of Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.102|<|0.001|TWO_SIDED|95.0|-0.82|-0.42|||ANOVA|||Month 2||-0.42|-0.82|< 0.001
70857425|NCT01931670|141200986|SUPERIORITY||LS Mean of Difference|-1.09|STANDARD_ERROR_OF_MEAN|0.102|<|0.001|TWO_SIDED|95.0|-1.29|-0.89|||ANOVA|||Month 2||-0.89|-1.29|< 0.001
71088219|NCT02175121|141682748|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|4.21||0.9791|TWO_SIDED|90.0|-7.07|6.85||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||6.85|-7.07|0.9791
71088220|NCT02175121|141682748|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.34|STANDARD_ERROR_OF_MEAN|4.28||0.0044|TWO_SIDED|90.0|5.26|19.41||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||19.41|5.26|0.0044
71088221|NCT02175121|141682749|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.77|STANDARD_ERROR_OF_MEAN|3.96||0.6553|TWO_SIDED|90.0|-4.78|8.33||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||8.33|-4.78|0.6553
71088222|NCT02175121|141682749|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.61|STANDARD_ERROR_OF_MEAN|4.05||0.2569|TWO_SIDED|90.0|-2.09|11.3||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||11.30|-2.09|0.2569
71088223|NCT02175121|141682749|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.64|STANDARD_ERROR_OF_MEAN|3.96||0.0553|TWO_SIDED|90.0|1.09|14.18||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||14.18|1.09|0.0553
71088224|NCT02175121|141682749|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.89|STANDARD_ERROR_OF_MEAN|4.01||0.0016|TWO_SIDED|90.0|6.26|19.53||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||19.53|6.26|0.0016
71088225|NCT02175121|141682749|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58|STANDARD_ERROR_OF_MEAN|3.58||0.8717|TWO_SIDED|90.0|-5.35|6.51||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||6.51|-5.35|0.8717
71088226|NCT02175121|141682749|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2|STANDARD_ERROR_OF_MEAN|3.66||0.743|TWO_SIDED|90.0|-4.86|7.26||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||7.26|-4.86|0.7430
71088227|NCT02175121|141682749|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.56|STANDARD_ERROR_OF_MEAN|3.58||0.2041|TWO_SIDED|90.0|-1.36|10.48||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||10.48|-1.36|0.2041
71088228|NCT02175121|141682749|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.92|STANDARD_ERROR_OF_MEAN|3.63|<|0.0001|TWO_SIDED|90.0|8.92|20.92||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||20.92|8.92|<0.0001
70946074|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7602|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7602
70946075|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6881|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6881
71088229|NCT02175121|141682750|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|4.08||0.975|TWO_SIDED|90.0|-6.62|6.87||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||6.87|-6.62|0.9750
71088230|NCT02175121|141682750|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.99|STANDARD_ERROR_OF_MEAN|4.16||0.3396|TWO_SIDED|90.0|-2.9|10.87||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||10.87|-2.90|0.3396
71088231|NCT02175121|141682750|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.49|STANDARD_ERROR_OF_MEAN|4.07||0.7142|TWO_SIDED|90.0|-8.23|5.24||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||5.24|-8.23|0.7142
71088232|NCT02175121|141682750|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.78|STANDARD_ERROR_OF_MEAN|4.14||0.0192|TWO_SIDED|90.0|2.94|16.63||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||16.63|2.94|0.0192
71088233|NCT02175121|141682750|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.84|STANDARD_ERROR_OF_MEAN|3.85||0.8277|TWO_SIDED|90.0|-7.2|5.52||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||5.52|-7.20|0.8277
71088234|NCT02175121|141682750|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.57|STANDARD_ERROR_OF_MEAN|3.93||0.8857|TWO_SIDED|90.0|-5.93|7.06||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||7.06|-5.93|0.8857
71088235|NCT02175121|141682750|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|3.84||0.8824|TWO_SIDED|90.0|-6.93|5.79||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||5.79|-6.93|0.8824
71088236|NCT02175121|141682750|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.23|STANDARD_ERROR_OF_MEAN|3.9||0.0192|TWO_SIDED|90.0|2.77|15.69||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||15.69|2.77|0.0192
71088237|NCT02557399|141682765|SUPERIORITY_OR_OTHER||difference in percent|-6.83||||0.008|TWO_SIDED|95.0|-11.88|-1.78||The analysis method was mixed model repeated measures analysis with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-1.78|-11.88|0.008
71088238|NCT02557399|141682766|SUPERIORITY_OR_OTHER||difference in percent|-0.25||||0.916|TWO_SIDED|95.0|-4.85|4.35||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1|||4.35|-4.85|0.916
71088239|NCT02557399|141682766|SUPERIORITY_OR_OTHER||difference in percent|-5.85||||0.01|TWO_SIDED|95.0|-10.29|-1.42||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4|||-1.42|-10.29|0.010
71088240|NCT02557399|141682766|SUPERIORITY_OR_OTHER||difference in percent|-2.35||||0.257|TWO_SIDED|95.0|-6.42|1.72||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8|||1.72|-6.42|0.257
70946076|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7883|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7883
70946077|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5374|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5374
70946078|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9774|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9774
70946079|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3082|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3082
71088241|NCT02557399|141682766|SUPERIORITY_OR_OTHER||difference in percent|-3.24||||0.062|TWO_SIDED|95.0|-6.64|0.16||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12|||0.16|-6.64|0.062
71088242|NCT02557399|141682767|SUPERIORITY_OR_OTHER||difference in percent|-5.08||||0.115|TWO_SIDED|95.0|-11.41|1.25||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||1.25|-11.41|0.115
71088243|NCT02557399|141682767|SUPERIORITY_OR_OTHER||difference in percent|-8.43||||0.005|TWO_SIDED|95.0|-14.35|-2.51||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-2.51|-14.35|0.005
71088244|NCT02557399|141682767|SUPERIORITY_OR_OTHER||difference in percent|-9.37|||<|0.001|TWO_SIDED|95.0|-14.42|-4.33||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-4.33|-14.42|<0.001
71088245|NCT02557399|141682767|SUPERIORITY_OR_OTHER||difference in percent|-6.69||||0.004|TWO_SIDED|95.0|-11.21|-2.16||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-2.16|-11.21|0.004
71088246|NCT02557399|141682767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.5||||0.015|TWO_SIDED|95.0|-8.1|-0.89||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for ILs|||-0.89|-8.10|0.015
71088247|NCT02557399|141682767|SUPERIORITY_OR_OTHER||difference in percent|2.71||||0.382|TWO_SIDED|95.0|-3.38|8.8||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||8.80|-3.38|0.382
71088248|NCT02557399|141682767|SUPERIORITY_OR_OTHER||difference in percent|-5.69||||0.085|TWO_SIDED|95.0|-12.17|0.78||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||0.78|-12.17|0.085
71125808|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.72||||99.32|TWO_SIDED|95.0|0.56|0.93||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.93|0.56|99.32
71125809|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||18.91|TWO_SIDED|95.0|0.93|1.2||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.20|0.93|18.91
70946080|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4373|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4373
71088249|NCT02557399|141682767|SUPERIORITY_OR_OTHER||difference in percent|-3.89||||0.186|TWO_SIDED|95.0|-9.67|1.88||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||1.88|-9.67|0.186
71088250|NCT02557399|141682767|SUPERIORITY_OR_OTHER||difference in percent|-0.59||||0.818|TWO_SIDED|95.0|-5.61|4.44||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||4.44|-5.61|0.818
70946081|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.654|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6540
70946082|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0002
70946083|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0696|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0696
70946084|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0029|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0029
70946085|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3695|TWO_SIDED||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3695
70946086|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9346|TWO_SIDED||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9346
70946087|NCT00551135|141392970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9631|TWO_SIDED||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9631
70946088|NCT00551135|141392971|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9025|TWO_SIDED||||||ANOVA|||"LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.9025
70946089|NCT00551135|141392971|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5652|TWO_SIDED||||||ANOVA|||"LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.5652
70946090|NCT00551135|141392971|SUPERIORITY_OR_OTHER_LEGACY|||||||0.792|TWO_SIDED||||||ANOVA|||"LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.7920
71125810|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||47.35|TWO_SIDED|95.0|0.87|1.15||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.15|0.87|47.35
70946091|NCT00551135|141392972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6679|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6679
70946092|NCT00551135|141392972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7308|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7308
70946093|NCT00551135|141392972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6781|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6781
70946094|NCT00551135|141392972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.093|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0930
70946095|NCT00551135|141392972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3751|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3751
70946096|NCT00551135|141392972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0111|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0111
70857426|NCT01931670|141200986|SUPERIORITY||LS Mean of Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.106|<|0.001|TWO_SIDED|95.0|-0.84|-0.42|||ANOVA|||Month 3||-0.42|-0.84|< 0.001
70857427|NCT01931670|141200986|SUPERIORITY||LS Mean of Difference|-1.14|STANDARD_ERROR_OF_MEAN|0.106|<|0.001|TWO_SIDED|95.0|-1.35|-0.93|||ANOVA|||Month 3||-0.93|-1.35|< 0.001
70857428|NCT01931670|141200986|SUPERIORITY||LS Mean of Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.109|<|0.001|TWO_SIDED|95.0|-0.84|-0.41|||ANOVA|||Month 4||-0.41|-0.84|< 0.001
70857429|NCT01931670|141200986|SUPERIORITY||LS Mean of Difference|-1.21|STANDARD_ERROR_OF_MEAN|0.109|<|0.001|TWO_SIDED|95.0|-1.43|-1.0|||ANOVA|||Month 4||-1.00|-1.43|< 0.001
70857430|NCT01931670|141200986|SUPERIORITY||LS Mean of Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.113|<|0.001|TWO_SIDED|95.0|-1.01|-0.57|||ANOVA|||Month 5||-0.57|-1.01|< 0.001
71088251|NCT02557399|141682767|SUPERIORITY_OR_OTHER||difference in percent|-3.78||||0.073|TWO_SIDED|95.0|-7.92|0.35||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||0.35|-7.92|0.073
70857431|NCT01931670|141200986|SUPERIORITY||LS Mean of Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.113|<|0.001|TWO_SIDED|95.0|-1.47|-1.02|||ANOVA|||Month 5||-1.02|-1.47|< 0.001
70857432|NCT01931670|141200986|SUPERIORITY||LS Mean of Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|-0.95|-0.49|||ANOVA|||Month 6||-0.49|-0.95|< 0.001
70946097|NCT00551135|141392972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6811|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6811
70857433|NCT01931670|141200986|SUPERIORITY||LS Mean of Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.117|<|0.001|TWO_SIDED|95.0|-1.5|-1.04|||ANOVA|||Month 6||-1.04|-1.50|< 0.001
70857434|NCT01931670|141200987|SUPERIORITY||LS Mean of Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.12||0.02|TWO_SIDED|97.5|-0.55|-0.01|||mixed-effects model|||Month 1||-0.01|-0.55|0.02
70946098|NCT00551135|141392972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7426|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7426
71088252|NCT02557399|141682768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.961|TWO_SIDED|95.0|-4.6|4.4||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for TLs. negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||4.4|-4.6|0.961
71088253|NCT02557399|141682768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.2||||0.015|TWO_SIDED|95.0|-11.2|-1.2||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for TLs. negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-1.2|-11.2|0.015
71088254|NCT02557399|141682768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7||||0.044|TWO_SIDED|95.0|-9.2|-0.1||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for TLs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-0.1|-9.2|0.044
71088255|NCT02557399|141682768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.747|TWO_SIDED|95.0|-4.9|3.5||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for TLs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||3.5|-4.9|0.747
71088256|NCT02557399|141682768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.338|TWO_SIDED|95.0|-5.3|1.8||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for TLs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||1.8|-5.3|0.338
71125811|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||78|TWO_SIDED|95.0|0.86|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.86|78.00
70857435|NCT01931670|141200987|SUPERIORITY||LS Mean of Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.119|<|0.001|TWO_SIDED|97.5|-0.72|-0.18|||mixed-effects model|||Month 1||-0.18|-0.72|< 0.001
70857436|NCT01931670|141200987|SUPERIORITY||LS Mean of Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.137|<|0.001|TWO_SIDED|97.5|-0.85|-0.23|||mixed-effects model|||Month 2||-0.23|-0.85|< 0.001
70857437|NCT01931670|141200987|SUPERIORITY||LS Mean of Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.137|<|0.001|TWO_SIDED|97.5|-1.27|-0.65|||mixed-effects model|||Month 2||-0.65|-1.27|< 0.001
70857438|NCT01931670|141200987|SUPERIORITY||LS Mean of Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.164|<|0.001|TWO_SIDED|97.5|-0.95|-0.21|||mixed-effects model|||Month 4||-0.21|-0.95|< 0.001
70946099|NCT00551135|141392972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1619|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1619
70946100|NCT00551135|141392972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1132|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1132
70946101|NCT00551135|141392972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9822|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9822
70946102|NCT00551135|141392972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1883|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1883
70946103|NCT00551135|141392972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9391|TWO_SIDED||||||ANOVA|||Day 1 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9391
70946104|NCT00551135|141392972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9664|TWO_SIDED||||||ANOVA|||Day 1 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9664
70946105|NCT00551135|141392972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0747|TWO_SIDED||||||ANOVA|||Day 1 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0747
70946106|NCT00551135|141392972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9681|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9681
70946107|NCT00551135|141392972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3246|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3246
70946108|NCT00551135|141392972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7984|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7984
70946109|NCT00551135|141392972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8581|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8581
70946110|NCT00551135|141392972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9677|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9677
70946111|NCT00551135|141392972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7104|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7104
71088257|NCT02557399|141682768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8||||0.068|TWO_SIDED|95.0|-3.8|0.1||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||0.1|-3.8|0.068
70946112|NCT00551135|141392972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8978|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8978
70946113|NCT00551135|141392972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.626|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6260
70946114|NCT00551135|141392972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4047|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4047
71088258|NCT02557399|141682768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0||||0.002|TWO_SIDED|95.0|-4.8|-1.1||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-1.1|-4.8|0.002
70946115|NCT00551135|141392972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4461|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4461
70946116|NCT00551135|141392972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9099|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9099
70946117|NCT00551135|141392972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8805|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8805
71125812|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.29||||2.65|TWO_SIDED|95.0|1.0|1.67||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.67|1.00|2.65
71125813|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||58.48|TWO_SIDED|95.0|0.73|1.29||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.29|0.73|58.48
71125814|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.75||||99.64|TWO_SIDED|95.0|0.61|0.92||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.No|TLC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.92|0.61|99.64
71125815|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.19||||1.9|TWO_SIDED|95.0|1.01|1.4||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.40|1.01|1.90
71125816|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||63.03|TWO_SIDED|95.0|0.81|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.81|63.03
71125817|NCT02294734|141757729|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.83||||99.19|TWO_SIDED|95.0|0.72|0.97||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.97|0.72|99.19
71125818|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||67.19|TWO_SIDED|95.0|0.64|1.33||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.33|0.64|67.19
71125819|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||44.8|TWO_SIDED|95.0|0.66|1.61||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.61|0.66|44.80
71125820|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||59.9|TWO_SIDED|95.0|0.61|1.46||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.46|0.61|59.90
71125821|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.91||||70.12|TWO_SIDED|95.0|0.63|1.31||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.31|0.63|70.12
71125822|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.82||||83.98|TWO_SIDED|95.0|0.54|1.22||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.22|0.54|83.98
70857439|NCT01931670|141200987|SUPERIORITY||LS Mean of Difference|-1.36|STANDARD_ERROR_OF_MEAN|0.164|<|0.001|TWO_SIDED|97.5|-1.72|-0.99|||mixed-effects model|||Month 4||-0.99|-1.72|< 0.001
70857440|NCT01931670|141200987|SUPERIORITY||LS Mean of Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.168|<|0.001|TWO_SIDED|97.5|-0.99|-0.23|||mixed-effects model|||Month 5||-0.23|-0.99|< 0.001
70857441|NCT01931670|141200987|SUPERIORITY||LS Mean of Difference|-1.37|STANDARD_ERROR_OF_MEAN|0.168|<|0.001|TWO_SIDED|97.5|-1.75|-1.0|||mixed-effects model|||Month 5||-1.00|-1.75|< 0.001
70857442|NCT01931670|141200987|SUPERIORITY||LS Mean of Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.175|<|0.001|TWO_SIDED|97.5|-1.08|-0.3|||mixed-effects model|||Month 6||-0.30|-1.08|< 0.001
70857443|NCT01931670|141200987|SUPERIORITY||LS Mean of Difference|-1.28|STANDARD_ERROR_OF_MEAN|0.175|<|0.001|TWO_SIDED|97.5|-1.67|-0.89|||mixed-effects model|||Month 6||-0.89|-1.67|< 0.001
70946118|NCT00551135|141392972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2348|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2348
70946119|NCT00551135|141392972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4445|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4445
70946120|NCT00551135|141392972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8849|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8849
70946121|NCT00551135|141392972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2796|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2796
70946122|NCT00551135|141392972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5225|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5225
70946123|NCT00551135|141392972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7015|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7015
71088259|NCT02557399|141682768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6||||0.002|TWO_SIDED|95.0|-4.3|-1.0||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-1.0|-4.3|0.002
71125823|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||34.93|TWO_SIDED|95.0|0.73|1.57||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.57|0.73|34.93
70946124|NCT00551135|141392976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3332|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3332
70946125|NCT00551135|141392976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0933|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0933
70857444|NCT01931670|141200988|SUPERIORITY||Difference in LS Means|-4.2|STANDARD_ERROR_OF_MEAN|1.55||0.007|TWO_SIDED|95.0|-7.25|-1.16|||ANCOVA|||Month 1||-1.16|-7.25|0.007
70946126|NCT00551135|141392976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0031|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0031
70946127|NCT00551135|141392976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9451|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9451
70946128|NCT00551135|141392976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7312|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7312
70946129|NCT00551135|141392976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0348|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0348
70946130|NCT00551135|141392976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8936|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8936
71088260|NCT02557399|141682768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9||||0.012|TWO_SIDED|95.0|-3.4|-0.4||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-0.4|-3.4|0.012
70857445|NCT01931670|141200988|SUPERIORITY||Difference in LS Means|-7.55|STANDARD_ERROR_OF_MEAN|1.55|<|0.001|TWO_SIDED|95.0|-10.6|-4.5|||ANCOVA|||Month 1||-4.50|-10.6|< 0.001
70857446|NCT01931670|141200988|SUPERIORITY||Difference in LS Means|-7.33|STANDARD_ERROR_OF_MEAN|1.74|<|0.001|TWO_SIDED|95.0|-10.75|-3.91|||ANCOVA|||Month 3||-3.91|-10.75|< 0.001
70946131|NCT00551135|141392976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7672|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7672
70946132|NCT00551135|141392976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4285|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4285
70946133|NCT00551135|141392976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0785|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0785
70946134|NCT00551135|141392976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3348|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3348
71125824|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.14||||32.45|TWO_SIDED|95.0|0.65|1.96||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.96|0.65|32.45
71125825|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.7||||95.35|TWO_SIDED|95.0|0.46|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.46|95.35
71125826|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||50.1|TWO_SIDED|95.0|0.66|1.54||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.54|0.66|50.10
71125827|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.94||||59.37|TWO_SIDED|95.0|0.55|1.6||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.60|0.55|59.37
71125828|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.8||||87.99|TWO_SIDED|95.0|0.55|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.55|87.99
71125829|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||70.87|TWO_SIDED|95.0|0.59|1.36||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.36|0.59|70.87
71125830|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.91||||63.71|TWO_SIDED|95.0|0.51|1.6||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.60|0.51|63.71
71125831|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.91||||65.99|TWO_SIDED|95.0|0.57|1.44||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.44|0.57|65.99
71125832|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||71.95|TWO_SIDED|95.0|0.6|1.32||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.32|0.60|71.95
71125833|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||48.28|TWO_SIDED|95.0|0.71|1.43||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.43|0.71|48.28
71125834|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||61.06|TWO_SIDED|95.0|0.65|1.39||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.39|0.65|61.06
70857447|NCT01931670|141200988|SUPERIORITY||Difference in LS Means|-15.43|STANDARD_ERROR_OF_MEAN|1.75|<|0.001|TWO_SIDED|95.0|-18.87|-11.99|||ANCOVA|||Month 3||-11.99|-18.87|< 0.001
70857448|NCT01931670|141200988|SUPERIORITY||Difference in LS Means|-8.7|STANDARD_ERROR_OF_MEAN|2.09|<|0.001|TWO_SIDED|95.0|-12.81|-4.6|||ANCOVA|||Month 6||-4.60|-12.81|< 0.001
70857449|NCT01931670|141200988|SUPERIORITY||Difference in LS Means|-16.92|STANDARD_ERROR_OF_MEAN|2.07|<|0.001|TWO_SIDED|95.0|-20.98|-12.86|||ANCOVA|||Month 6||-12.86|-20.98|< 0.001
71088261|NCT02557399|141682768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1||||0.078|TWO_SIDED|95.0|-2.4|0.1||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||0.1|-2.4|0.078
71088262|NCT02557399|141682768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8||||0.367|TWO_SIDED|95.0|-2.1|5.7||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||5.7|-2.1|0.367
71088263|NCT02557399|141682768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.1||||0.148|TWO_SIDED|95.0|-7.4|1.1||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||1.1|-7.4|0.148
71088264|NCT02557399|141682768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.314|TWO_SIDED|95.0|-5.9|1.9||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||1.9|-5.9|0.314
71088265|NCT02557399|141682768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2||||0.494|TWO_SIDED|95.0|-2.3|4.7||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||4.7|-2.3|0.494
70946135|NCT00551135|141392976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1366|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1366
71088266|NCT02557399|141682768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.684|TWO_SIDED|95.0|-3.5|2.3||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||2.3|-3.5|0.684
71088267|NCT02557399|141682769|SUPERIORITY_OR_OTHER||Difference in percentage|2.3||||0.047|TWO_SIDED|95.0|0.1|4.6||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1.The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||4.6|0.1|0.047
71088268|NCT02557399|141682769|SUPERIORITY_OR_OTHER||Difference in percentage|3.0||||0.185|TWO_SIDED|95.0|-1.3|7.3||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||7.3|-1.3|0.185
71125835|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.19||||18.05|TWO_SIDED|95.0|0.82|1.74||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.74|0.82|18.05
71125836|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||61.12|TWO_SIDED|95.0|0.53|1.61||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.61|0.53|61.12
70857450|NCT01931670|141200989|SUPERIORITY||Difference in LS Means|-0.57|STANDARD_ERROR_OF_MEAN|1.95||0.77|TWO_SIDED|95.0|-4.4|3.26|||ANCOVA|||Month 1||3.26|-4.40|0.77
70857451|NCT01931670|141200989|SUPERIORITY||Difference in LS Means|-4.4|STANDARD_ERROR_OF_MEAN|1.93||0.023|TWO_SIDED|95.0|-8.19|-0.61|||ANCOVA|||Month 1||-0.61|-8.19|0.023
70857452|NCT01931670|141200989|SUPERIORITY||Difference in LS Means|-2.74|STANDARD_ERROR_OF_MEAN|2.42||0.257|TWO_SIDED|95.0|-7.5|2.01|||ANCOVA|||Month 3||2.01|-7.50|0.257
71088269|NCT02557399|141682769|SUPERIORITY_OR_OTHER||Difference in percentage|3.7||||0.251|TWO_SIDED|95.0|-2.5|9.9||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||9.9|-2.5|0.251
71088270|NCT02557399|141682769|SUPERIORITY_OR_OTHER||Difference in percentage|10.2||||0.006|TWO_SIDED|95.0|2.4|18.0||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||18.0|2.4|0.006
70946136|NCT00551135|141392976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3338|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3338
71088271|NCT02557399|141682769|SUPERIORITY_OR_OTHER||Difference in percentage|10.7||||0.022|TWO_SIDED|95.0|0.9|20.4||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||20.4|0.9|0.022
71088272|NCT02557399|141682770|SUPERIORITY_OR_OTHER||Difference in percentage|1.8||||0.129|TWO_SIDED|95.0|-0.7|4.3||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||4.3|-0.7|0.129
71088273|NCT02557399|141682770|SUPERIORITY_OR_OTHER||Difference in percentage|1.3||||0.612|TWO_SIDED|95.0|-3.4|5.9||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||5.9|-3.4|0.612
71088274|NCT02557399|141682770|SUPERIORITY_OR_OTHER||Difference in percentage|7.1||||0.016|TWO_SIDED|95.0|1.1|13.2||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||13.2|1.1|0.016
70946137|NCT00551135|141392976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.446|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4460
71088275|NCT02557399|141682770|SUPERIORITY_OR_OTHER||Difference in percentage|7.9||||0.034|TWO_SIDED|95.0|0.3|15.5||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||15.5|0.3|0.034
71088276|NCT02557399|141682770|SUPERIORITY_OR_OTHER||Difference in percentage|11.3||||0.018|TWO_SIDED|95.0|1.4|21.3||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||21.3|1.4|0.018
71088277|NCT02557399|141682771|SUPERIORITY_OR_OTHER||Difference in percentage|3.9||||0.379|TWO_SIDED|95.0|-4.5|12.3||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||12.3|-4.5|0.379
71088278|NCT02557399|141682771|SUPERIORITY_OR_OTHER||Difference in percentage|4.7||||0.409|TWO_SIDED|95.0|-5.7|15.1||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||15.1|-5.7|0.409
71088279|NCT02557399|141682771|SUPERIORITY_OR_OTHER||Difference in percentage|7.0||||0.18|TWO_SIDED|95.0|-3.1|17.0||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||17.0|-3.1|0.180
71125837|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||64.4|TWO_SIDED|95.0|0.61|1.41||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.41|0.61|64.40
71088280|NCT02557399|141682771|SUPERIORITY_OR_OTHER||Difference in percentage|-0.5||||0.81|TWO_SIDED|95.0|-8.8|7.7||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||7.7|-8.8|0.810
71088281|NCT02557399|141682771|SUPERIORITY_OR_OTHER||Difference in percentage|1.9||||0.648|TWO_SIDED|95.0|-5.2|9.0||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||9.0|-5.2|0.648
71088282|NCT02557399|141682771|SUPERIORITY_OR_OTHER||Difference in percentage|9.1||||0.048|TWO_SIDED|95.0|-1.3|19.6||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||19.6|-1.3|0.048
71088283|NCT02557399|141682771|SUPERIORITY_OR_OTHER||Difference in percentage|11.2||||0.016|TWO_SIDED|95.0|1.8|20.6||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||20.6|1.8|0.016
71088284|NCT02557399|141682771|SUPERIORITY_OR_OTHER||Difference in percentage|8.6||||0.044|TWO_SIDED|95.0|0.4|16.9||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||16.9|0.4|0.044
71088285|NCT02557399|141682771|SUPERIORITY_OR_OTHER||Difference in percentage|3.6||||0.345|TWO_SIDED|95.0|-3.8|11.0||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||11.0|-3.8|0.345
71088286|NCT02557399|141682771|SUPERIORITY_OR_OTHER||Difference in percentage|2.6||||0.424|TWO_SIDED|95.0|-3.5|8.7||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||8.7|-3.5|0.424
71088287|NCT02557399|141682771|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0||||0.527|TWO_SIDED|95.0|-9.4|5.5||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||5.5|-9.4|0.527
70857453|NCT01931670|141200989|SUPERIORITY||Difference in LS Means|-10.69|STANDARD_ERROR_OF_MEAN|2.38|<|0.001|TWO_SIDED|95.0|-15.37|-6.01|||ANCOVA|||Month 3||-6.01|-15.37|< 0.001
70946138|NCT00551135|141392976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1078|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1078
70946139|NCT00551135|141392976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8273|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8273
71088288|NCT02557399|141682771|SUPERIORITY_OR_OTHER||Difference in percentage|3.3||||0.584|TWO_SIDED|95.0|-6.7|13.4||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||13.4|-6.7|0.584
71088289|NCT02557399|141682771|SUPERIORITY_OR_OTHER||Difference in percentage|3.9||||0.519|TWO_SIDED|95.0|-6.5|14.3||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||14.3|-6.5|0.519
71088290|NCT02557399|141682771|SUPERIORITY_OR_OTHER||Difference in percentage|-0.8||||0.766|TWO_SIDED|95.0|-10.1|8.5||The P-values are based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||8.5|-10.1|0.766
71088291|NCT02557399|141682771|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3||||0.666|TWO_SIDED|95.0|-5.8|10.5||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||10.5|-5.8|0.666
71088292|NCT02557399|141682775|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.017|TWO_SIDED|95.0|-0.4|-0.04|||mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-0.04|-0.40|0.017
71088293|NCT02557399|141682775|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.017|TWO_SIDED|95.0|-0.4|-0.04|||mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-0.04|-0.40|0.017
71088294|NCT02557399|141682775|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.024|TWO_SIDED|95.0|-0.41|-0.03|||mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-0.03|-0.41|0.024
71088295|NCT02557399|141682775|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.08|TWO_SIDED|95.0|-0.36|0.02|||mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||0.02|-0.36|0.080
71088296|NCT02848664|141682779|OTHER|Same DOSS score before and after device use for 3 months or improved DOSS score after device use for 3 months|||||<|0.025||||||p values adjusted for multiple comparisons (two outcome measures)|Wilcoxon (Mann-Whitney)|||Examined change in DOSS for each participant from before to after three months of device use. Examined numbers of participants who showed either worsening of DOSS, no improvement in DOSS or improvement of DOSS.||||<0.025
71088297|NCT02848664|141682780|EQUIVALENCE|Examination of whether the level of swallowing handicap is changed following device use|Mean Difference (Net)|22.571||||0.016|TWO_SIDED|95.0|6.003|39.14|||t-test, 2 sided|||||39.140|6.003|0.016
71088298|NCT02848664|141682781|EQUIVALENCE|whether the degree of laryngeal elevation relative to hyoid elevation became greater or less after device use for 3 months||||||0.046|||||||t-test, 2 sided|||||||0.046
71088299|NCT02848664|141682782|EQUIVALENCE|pairwise comparison within subject comparing baseline with 3 months post device use|Mean Difference (Final Values)|-52.78||||0.037|TWO_SIDED|95.0|-100.751|-4.809|||ANOVA|||||-4.809|-100.751|0.037
71088300|NCT00402727|141682783|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set to 10% in the protocol, in agreeance with FDA recommendations. Sample size was estimated using the method as described in Farrington-Manning. Estimation was performed to achieve 85% power, based on the equivalence delta of 10%, and a clinical success rate of 80% in the per protocol population|Difference of cure rates (in percent)|-1.0||||||95.0|-5.3|3.9|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||3.9|-5.3|
71088301|NCT00402727|141682784|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of cure rates (in percent)|1.3||||||95.0|-3.8|6.3|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||6.3|-3.8|
71088302|NCT00402727|141682785|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of improvement rates (in %)|-0.7||||||95.0|-1.6|0.6|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||0.6|-1.6|
71088303|NCT00402727|141682786|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of improvement rates (in %)|1.4||||||95.0|-1.3|3.9|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||3.9|-1.3|
71088304|NCT00402727|141682787|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of resolution rates (in %)|0.2||||||95.0|-3.1|2.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||2.4|-3.1|
71088305|NCT00402727|141682788|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of resolution rates (in %)|1.6||||||95.0|-2.4|5.3|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||5.3|-2.4|
71088306|NCT00402727|141682789|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-8.5||||||95.0|-17.0|-1.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||-1.4|-17.0|
70857454|NCT01931670|141200989|SUPERIORITY||Difference in LS Means|-2.93|STANDARD_ERROR_OF_MEAN|2.91||0.315|TWO_SIDED|95.0|-8.66|2.8|||ANCOVA|||Month 6||2.80|-8.66|0.315
70857455|NCT01931670|141200989|SUPERIORITY||Difference in LS Means|-14.1|STANDARD_ERROR_OF_MEAN|2.82|<|0.001|TWO_SIDED|95.0|-19.64|-8.55|||ANCOVA|||Month 6||-8.55|-19.64|< 0.001
70857456|NCT01931670|141200990|SUPERIORITY||Difference in LS Means|-1.01|STANDARD_ERROR_OF_MEAN|0.43||0.019|TWO_SIDED|95.0|-1.86|-0.17|||ANCOVA|||Month 1||-0.17|-1.86|0.019
71088307|NCT00402727|141682790|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-8.6||||||95.0|-17.6|-0.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||-0.4|-17.6|
70857457|NCT01931670|141200990|SUPERIORITY||Difference in LS Means|-0.95|STANDARD_ERROR_OF_MEAN|0.433||0.028|TWO_SIDED|95.0|-1.8|-0.1|||ANCOVA|||Month 1||-0.10|-1.80|0.028
70857458|NCT01931670|141200990|SUPERIORITY||Difference in LS Means|-0.98|STANDARD_ERROR_OF_MEAN|0.397||0.014|TWO_SIDED|95.0|-1.76|-0.2|||ANCOVA|||Month 2||-0.20|-1.76|0.014
70946140|NCT00551135|141392976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.614|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6140
71088308|NCT00402727|141682791|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-3.9||||||95.0|-9.5|1.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||1.4|-9.5|
70946141|NCT00551135|141392976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1684|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1684
70946142|NCT00551135|141392976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1285|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1285
70946143|NCT00551135|141392976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.264|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2640
70857459|NCT01931670|141200990|SUPERIORITY||Difference in LS Means|-1.44|STANDARD_ERROR_OF_MEAN|0.397|<|0.001|TWO_SIDED|95.0|-2.22|-0.65|||ANCOVA|||Month 2||-0.65|-2.22|< 0.001
70857460|NCT01931670|141200990|SUPERIORITY||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.432||0.121|TWO_SIDED|95.0|-1.52|0.18|||ANCOVA|||Month 3||0.18|-1.52|0.121
70946144|NCT00551135|141392976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8956|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8956
70946145|NCT00551135|141392976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0058|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0058
70946146|NCT00551135|141392976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9929|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9929
70946147|NCT00551135|141392976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0473|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0473
70946148|NCT00551135|141392976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2426|TWO_SIDED||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2426
70946149|NCT00551135|141392976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3478|TWO_SIDED||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3478
70946150|NCT00551135|141392976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1694|TWO_SIDED||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1694
70946151|NCT00551135|141392977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.063|TWO_SIDED||||||ANOVA|||24 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0630
70946152|NCT00551135|141392977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0347|TWO_SIDED||||||ANOVA|||24 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0347
70946153|NCT00551135|141392977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0024|TWO_SIDED||||||ANOVA|||24 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0024
70946154|NCT00551135|141392977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0767|TWO_SIDED||||||ANOVA|||48 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0767
70946155|NCT00551135|141392977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1327|TWO_SIDED||||||ANOVA|||48 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1327
70946156|NCT00551135|141392977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0078|TWO_SIDED||||||ANOVA|||48 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0078
70946157|NCT00551135|141392977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0694|TWO_SIDED||||||ANOVA|||72 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0694
70946158|NCT00551135|141392977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2173|TWO_SIDED||||||ANOVA|||72 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2173
70857461|NCT01931670|141200990|SUPERIORITY||Difference in LS Means|-1.41|STANDARD_ERROR_OF_MEAN|0.431||0.001|TWO_SIDED|95.0|-2.25|-0.56|||ANCOVA|||Month 3||-0.56|-2.25|0.001
70857462|NCT01931670|141200990|SUPERIORITY||Difference in LS Means|-1.25|STANDARD_ERROR_OF_MEAN|0.561||0.026|TWO_SIDED|95.0|-2.35|-0.15|||ANCOVA|||Month 4||-0.15|-2.35|0.026
70857463|NCT01931670|141200990|SUPERIORITY||Difference in LS Means|-1.48|STANDARD_ERROR_OF_MEAN|0.555||0.008|TWO_SIDED|95.0|-2.57|-0.39|||ANCOVA|||Month 4||-0.39|-2.57|0.008
70857464|NCT01931670|141200990|SUPERIORITY||Difference in LS Means|-0.73|STANDARD_ERROR_OF_MEAN|0.327||0.027|TWO_SIDED|95.0|-1.37|-0.08|||ANCOVA|||Month 5||-0.08|-1.37|0.027
70857465|NCT01931670|141200990|SUPERIORITY||Difference in LS Means|-1.11|STANDARD_ERROR_OF_MEAN|0.327|<|0.001|TWO_SIDED|95.0|-1.75|-0.47|||ANCOVA|||Month 5||-0.47|-1.75|< 0.001
70946159|NCT00551135|141392977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0193|TWO_SIDED||||||ANOVA|||72 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0193
70946160|NCT00551135|141392977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0673|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0673
70946161|NCT00551135|141392977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2629|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2629
70946162|NCT00551135|141392977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0388|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0388
70946163|NCT00551135|141392977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0651|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0651
70946164|NCT00551135|141392977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3242|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3242
70946165|NCT00551135|141392977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0345|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0345
70946166|NCT00551135|141392977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0487|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0487
70946167|NCT00551135|141392977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3384|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3384
71088309|NCT00402727|141682792|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-5.6||||||95.0|-11.4|-0.8|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||-0.8|-11.4|
71088310|NCT00402727|141682793|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-0.1||||||95.0|-6.9|5.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||5.4|-6.9|
71088311|NCT00402727|141682794|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-2.9||||||95.0|-9.3|2.2|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||2.2|-9.3|
71088312|NCT01687218|141682802|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.03||||0.88|TWO_SIDED|95.0|0.73|1.44|||Generalized Estimating Equation (GEE)||It shows the rate ratio (RR) based on a GEE model comparing the Daily Rectal regimen with the Oral regimen and controlling for period in the model.|Since some participants have more than one safety event per period of treatment regimen, a Generalized Estimating Equation (GEE) model with a Poisson (log) link, exchangeable correlation structure, and robust standard errors were used.||1.44|0.73|0.88
71088313|NCT01687218|141682802|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.88||||0.43|TWO_SIDED|95.0|0.64|1.21|||Generalized Estimating Equation (GEE)||It shows the rate ratio (RR) based on a GEE model comparing the RAI Rectal regimen with the Oral regimen and controlling for period in the model.|Since some participants have more than one safety event per period of treatment regimen, a Generalized Estimating Equation (GEE) model with a Poisson (log) link, exchangeable correlation structure, and robust standard errors were used.||1.21|0.64|0.43
71088314|NCT01687218|141682803|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.15|0.5|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.||0.50|0.15|<0.0001
71088315|NCT01687218|141682803|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.37||||0.002|TWO_SIDED|95.0|0.2|0.7|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.||0.70|0.20|0.002
70946168|NCT00551135|141392977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0467|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0467
70946169|NCT00551135|141392977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0347|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0347
70946170|NCT00551135|141392977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3086|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3086
71125838|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||38.12|TWO_SIDED|95.0|0.69|1.66||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.66|0.69|38.12
70857466|NCT01931670|141200990|SUPERIORITY||Difference in LS Means|-0.57|STANDARD_ERROR_OF_MEAN|0.391||0.143|TWO_SIDED|95.0|-1.34|0.2|||ANCOVA|||Month 6||0.20|-1.34|0.143
70946171|NCT00551135|141392977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0406|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0406
71125839|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.85||||91|TWO_SIDED|95.0|0.67|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.67|91.00
70857467|NCT01931670|141200990|SUPERIORITY||Difference in LS Means|-0.91|STANDARD_ERROR_OF_MEAN|0.385||0.019|TWO_SIDED|95.0|-1.67|-0.15|||ANCOVA|||Month 6||-0.15|-1.67|0.019
70857468|NCT01931670|141200991|SUPERIORITY||Difference in LS Means|-0.63|STANDARD_ERROR_OF_MEAN|0.415||0.131|TWO_SIDED|95.0|-1.44|0.19|||ANCOVA|||Month 1||0.19|-1.44|0.131
70946172|NCT00551135|141392978|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4177|TWO_SIDED||||||ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4177
71125840|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.81||||94.52|TWO_SIDED|95.0|0.62|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.62|94.52
71125841|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.9||||82.11|TWO_SIDED|95.0|0.72|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.72|82.11
71125842|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||48.1|TWO_SIDED|95.0|0.64|1.6||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.60|0.64|48.10
71125843|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.93||||65.66|TWO_SIDED|95.0|0.64|1.36||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.36|0.64|65.66
71125844|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.25||||11.46|TWO_SIDED|95.0|0.87|1.8||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.80|0.87|11.46
71125845|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.91||||77.2|TWO_SIDED|95.0|0.7|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.70|77.20
71125846|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.86||||87.35|TWO_SIDED|95.0|0.66|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.66|87.35
70946173|NCT00551135|141392978|SUPERIORITY_OR_OTHER_LEGACY|||||||0.441|TWO_SIDED||||||ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4410
70857469|NCT01931670|141200991|SUPERIORITY||Difference in LS Means|-0.85|STANDARD_ERROR_OF_MEAN|0.409||0.037|TWO_SIDED|95.0|-1.65|-0.05|||ANCOVA|||Month 1||-0.05|-1.65|0.037
70946174|NCT00551135|141392978|SUPERIORITY_OR_OTHER_LEGACY|||||||0.556|TWO_SIDED||||||ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5560
70857470|NCT01931670|141200991|SUPERIORITY||Difference in LS Means|-1.12|STANDARD_ERROR_OF_MEAN|0.423||0.008|TWO_SIDED|95.0|-1.96|-0.29|||ANCOVA|||Month 2||-0.29|-1.96|0.008
70857471|NCT01931670|141200991|SUPERIORITY||Difference in LS Means|-1.44|STANDARD_ERROR_OF_MEAN|0.426|<|0.001|TWO_SIDED|95.0|-2.27|-0.6|||ANCOVA|||Month 2||-0.60|-2.27|< 0.001
70946175|NCT00551135|141392979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4273|TWO_SIDED||||||ANOVA|||Total CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4273
70946176|NCT00551135|141392979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4466|TWO_SIDED||||||ANOVA|||Total CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4466
71088316|NCT01687218|141682804|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.56||||0.08|TWO_SIDED|95.0|0.29|1.08|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.||1.08|0.29|0.08
70857472|NCT01931670|141200991|SUPERIORITY||Difference in LS Means|-0.91|STANDARD_ERROR_OF_MEAN|0.434||0.036|TWO_SIDED|95.0|-1.76|-0.06|||ANCOVA|||Month 3||-0.06|-1.76|0.036
70946177|NCT00551135|141392979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3785|TWO_SIDED||||||ANOVA|||Total CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3785
71088317|NCT01687218|141682804|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.76||||0.46|TWO_SIDED|95.0|0.37|1.56|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.||1.56|0.37|0.46
71088318|NCT01687218|141682805|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.38||||0.0004|TWO_SIDED|95.0|0.22|0.65|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.||0.65|0.22|0.0004
70857473|NCT01931670|141200991|SUPERIORITY||Difference in LS Means|-0.91|STANDARD_ERROR_OF_MEAN|0.431||0.035|TWO_SIDED|95.0|-1.76|-0.06|||ANCOVA|||Month 3||-0.06|-1.76|0.035
70946178|NCT00551135|141392979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5272|TWO_SIDED||||||ANOVA|||Total CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5272
70946179|NCT00551135|141392979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4257|TWO_SIDED||||||ANOVA|||Total CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4257
70946180|NCT00551135|141392979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1428|TWO_SIDED||||||ANOVA|||Total CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1428
70857474|NCT01931670|141200991|SUPERIORITY||Difference in LS Means|-0.34|STANDARD_ERROR_OF_MEAN|0.453||0.452|TWO_SIDED|95.0|-1.23|0.55|||ANCOVA|||Month 4||0.55|-1.23|0.452
70946181|NCT00551135|141392979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2316|TWO_SIDED||||||ANOVA|||Total CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2316
70946182|NCT00551135|141392979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3468|TWO_SIDED||||||ANOVA|||Total CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3468
70946183|NCT00551135|141392979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5367|TWO_SIDED||||||ANOVA|||Total CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5367
70946184|NCT00551135|141392979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0549|TWO_SIDED||||||ANOVA|||Total CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0549
70857475|NCT01931670|141200991|SUPERIORITY||Difference in LS Means|-1.33|STANDARD_ERROR_OF_MEAN|0.432||0.002|TWO_SIDED|95.0|-2.18|-0.48|||ANCOVA|||Month 4||-0.48|-2.18|0.002
70857476|NCT01931670|141200991|SUPERIORITY||Difference in LS Means|-1.12|STANDARD_ERROR_OF_MEAN|0.443||0.012|TWO_SIDED|95.0|-1.99|-0.25|||ANCOVA|||Month 5||-0.25|-1.99|0.012
70857477|NCT01931670|141200991|SUPERIORITY||Difference in LS Means|-1.64|STANDARD_ERROR_OF_MEAN|0.439|<|0.001|TWO_SIDED|95.0|-2.5|-0.78|||ANCOVA|||Month 5||-0.78|-2.5|< 0.001
70857478|NCT01931670|141200991|SUPERIORITY||Difference in LS Means|-0.73|STANDARD_ERROR_OF_MEAN|0.478||0.13|TWO_SIDED|95.0|-1.67|0.21|||ANCOVA|||Month 6||0.21|-1.67|0.13
70946185|NCT00551135|141392979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1351|TWO_SIDED||||||ANOVA|||Total CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1351
70857479|NCT01931670|141200991|SUPERIORITY||Difference in LS Means|-1.45|STANDARD_ERROR_OF_MEAN|0.454||0.001|TWO_SIDED|95.0|-2.34|-0.56|||ANCOVA|||Month 6||-0.56|-2.34|0.001
70857480|NCT01931670|141200992|SUPERIORITY||Difference in LS Means|-1.34|STANDARD_ERROR_OF_MEAN|1.01||0.186|TWO_SIDED|95.0|-3.32|0.65|||ANCOVA|||Month 1||0.65|-3.32|0.186
70857481|NCT01931670|141200992|SUPERIORITY||Difference in LS Means|-3.09|STANDARD_ERROR_OF_MEAN|1.013||0.002|TWO_SIDED|95.0|-5.08|-1.1|||ANCOVA|||Month 1||-1.10|-5.08|0.002
70857482|NCT01931670|141200992|SUPERIORITY||Difference in LS Means|-1.31|STANDARD_ERROR_OF_MEAN|1.005||0.195|TWO_SIDED|95.0|-3.28|0.67|||ANCOVA|||Month 2||0.67|-3.28|0.195
70857483|NCT01931670|141200992|SUPERIORITY||Difference in LS Means|-3.65|STANDARD_ERROR_OF_MEAN|1.007|<|0.001|TWO_SIDED|95.0|-5.63|-1.67|||ANCOVA|||Month 2||-1.67|-5.63|< 0.001
70857484|NCT01931670|141200992|SUPERIORITY||Difference in LS Means|-2.03|STANDARD_ERROR_OF_MEAN|1.02||0.047|TWO_SIDED|95.0|-4.03|-0.02|||ANCOVA|||Month 3||-0.02|-4.03|0.047
71088319|NCT01687218|141682805|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.7||||0.23|TWO_SIDED|95.0|0.39|1.25|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.||1.25|0.39|0.23
70857485|NCT01931670|141200992|SUPERIORITY||Difference in LS Means|-3.2|STANDARD_ERROR_OF_MEAN|1.021||0.002|TWO_SIDED|95.0|-5.21|-1.19|||ANCOVA|||Month 3||-1.19|-5.21|0.002
70857486|NCT01931670|141200992|SUPERIORITY||Difference in LS Means|-1.63|STANDARD_ERROR_OF_MEAN|0.998||0.103|TWO_SIDED|95.0|-3.59|0.33|||ANCOVA|||Month 4||0.33|-3.59|0.103
70857487|NCT01931670|141200992|SUPERIORITY||Difference in LS Means|-4.78|STANDARD_ERROR_OF_MEAN|0.99|<|0.001|TWO_SIDED|95.0|-6.72|-2.83|||ANCOVA|||Month 4||-2.83|-6.72|< 0.001
70857488|NCT01931670|141200992|SUPERIORITY||Difference in LS Means|-2.29|STANDARD_ERROR_OF_MEAN|0.97||0.019|TWO_SIDED|95.0|-4.2|-0.38|||ANCOVA|||Month 5||-0.38|-4.20|0.019
70857489|NCT01931670|141200992|SUPERIORITY||Difference in LS Means|-5.14|STANDARD_ERROR_OF_MEAN|0.975|<|0.001|TWO_SIDED|95.0|-7.06|-3.22|||ANCOVA|||Month 5||-3.22|-7.06|< 0.001
70857490|NCT01931670|141200992|SUPERIORITY||Difference in LS Means|-0.97|STANDARD_ERROR_OF_MEAN|1.112||0.383|TWO_SIDED|95.0|-3.16|1.22|||ANCOVA|||Month 6||1.22|-3.16|0.383
70857491|NCT01931670|141200992|SUPERIORITY||Difference in LS Means|-3.02|STANDARD_ERROR_OF_MEAN|1.092||0.006|TWO_SIDED|95.0|-5.17|-0.87|||ANCOVA|||Month 6||-0.87|-5.17|0.006
70857492|NCT01931670|141200993|SUPERIORITY||Difference in LS Means|0.01|STANDARD_ERROR_OF_MEAN|0.422||0.975|TWO_SIDED|95.0|-0.81|0.84|||ANCOVA|||Month 1||0.84|-0.81|0.975
70857493|NCT01931670|141200993|SUPERIORITY||Difference in LS Means|-0.02|STANDARD_ERROR_OF_MEAN|0.415||0.969|TWO_SIDED|95.0|-0.83|0.8|||ANCOVA|||Month 1||0.80|-0.83|0.969
70857494|NCT01931670|141200993|SUPERIORITY||Difference in LS Means|-0.22|STANDARD_ERROR_OF_MEAN|0.389||0.569|TWO_SIDED|95.0|-0.99|0.54|||ANCOVA|||Month 2||0.54|-0.99|0.569
70857495|NCT01931670|141200993|SUPERIORITY||Difference in LS Means|-0.4|STANDARD_ERROR_OF_MEAN|0.393||0.311|TWO_SIDED|95.0|-1.17|0.37|||ANCOVA|||Month 2||0.37|-1.17|0.311
70857496|NCT01931670|141200993|SUPERIORITY||Difference in LS Means|0.43|STANDARD_ERROR_OF_MEAN|0.505||0.398|TWO_SIDED|95.0|-0.56|1.42|||ANCOVA|||Month 3||1.42|-0.56|0.398
70946186|NCT00551135|141392979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9599|TWO_SIDED||||||ANOVA|||Total CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9599
70857497|NCT01931670|141200993|SUPERIORITY||Difference in LS Means|-0.15|STANDARD_ERROR_OF_MEAN|0.505||0.761|TWO_SIDED|95.0|-1.15|0.84|||ANCOVA|||Month 3||0.84|-1.15|0.761
70857498|NCT01931670|141200993|SUPERIORITY||Difference in LS Means|0.08|STANDARD_ERROR_OF_MEAN|0.491||0.874|TWO_SIDED|95.0|-0.89|1.04|||ANCOVA|||Month 4||1.04|-0.89|0.874
70857499|NCT01931670|141200993|SUPERIORITY||Difference in LS Means|-0.93|STANDARD_ERROR_OF_MEAN|0.468||0.048|TWO_SIDED|95.0|-1.85|-0.01|||ANCOVA|||Month 4||-0.01|-1.85|0.048
70857500|NCT01931670|141200993|SUPERIORITY||Difference in LS Means|-0.89|STANDARD_ERROR_OF_MEAN|0.635||0.16|TWO_SIDED|95.0|-2.14|0.35|||ANCOVA|||Month 5||0.35|-2.14|0.16
70857501|NCT01931670|141200993|SUPERIORITY||Difference in LS Means|-0.9|STANDARD_ERROR_OF_MEAN|0.63||0.152|TWO_SIDED|95.0|-2.14|0.33|||ANCOVA|||Month 5||0.33|-2.14|0.152
70857502|NCT01931670|141200993|SUPERIORITY||Difference in LS Means|-0.83|STANDARD_ERROR_OF_MEAN|0.498||0.095|TWO_SIDED|95.0|-1.81|0.15|||ANCOVA|||Month 6||0.15|-1.81|0.095
70857503|NCT01931670|141200993|SUPERIORITY||Difference in LS Means|-0.86|STANDARD_ERROR_OF_MEAN|0.474||0.071|TWO_SIDED|95.0|-1.79|0.07|||ANCOVA|||Month 6||0.07|-1.79|0.071
70857504|NCT01931670|141200994|SUPERIORITY||Difference in LS Means|-1.83|STANDARD_ERROR_OF_MEAN|1.106||0.098|TWO_SIDED|95.0|-4.01|0.34|||ANCOVA|||Month 1||0.34|-4.01|0.098
70857505|NCT01931670|141200994|SUPERIORITY||Difference in LS Means|-3.72|STANDARD_ERROR_OF_MEAN|1.113|<|0.001|TWO_SIDED|95.0|-5.91|-1.54|||ANCOVA|||Month 1||-1.54|-5.91|< 0.001
70857506|NCT01931670|141200994|SUPERIORITY||Difference in LS Means|-2.02|STANDARD_ERROR_OF_MEAN|1.091||0.065|TWO_SIDED|95.0|-4.16|0.13|||ANCOVA|||Month 2||0.13|-4.16|0.065
70857507|NCT01931670|141200994|SUPERIORITY||Difference in LS Means|-5.1|STANDARD_ERROR_OF_MEAN|1.089|<|0.001|TWO_SIDED|95.0|-7.24|-2.96|||ANCOVA|||Month 2||-2.96|-7.24|< 0.001
70857508|NCT01931670|141200994|SUPERIORITY||Difference in LS Means|-2.65|STANDARD_ERROR_OF_MEAN|1.14||0.02|TWO_SIDED|95.0|-4.89|-0.41|||ANCOVA|||Month 3||-0.41|-4.89|0.02
70857509|NCT01931670|141200994|SUPERIORITY||Difference in LS Means|-4.64|STANDARD_ERROR_OF_MEAN|1.135|<|0.001|TWO_SIDED|95.0|-6.87|-2.41|||ANCOVA|||Month 3||-2.41|-6.87|< 0.001
70857510|NCT01931670|141200994|SUPERIORITY||Difference in LS Means|-2.72|STANDARD_ERROR_OF_MEAN|1.138||0.017|TWO_SIDED|95.0|-4.95|-0.48|||ANCOVA|||Month 4||-0.48|-4.95|0.017
70857511|NCT01931670|141200994|SUPERIORITY||Difference in LS Means|-6.27|STANDARD_ERROR_OF_MEAN|1.124|<|0.001|TWO_SIDED|95.0|-8.48|-4.06|||ANCOVA|||Month 4||-4.06|-8.48|< 0.001
70857512|NCT01931670|141200994|SUPERIORITY||Difference in LS Means|-2.49|STANDARD_ERROR_OF_MEAN|1.095||0.023|TWO_SIDED|95.0|-4.64|-0.34|||ANCOVA|||Month 5||-0.34|-4.64|0.023
70857513|NCT01931670|141200994|SUPERIORITY||Difference in LS Means|-5.83|STANDARD_ERROR_OF_MEAN|1.095|<|0.001|TWO_SIDED|95.0|-7.98|-3.68|||ANCOVA|||Month 5||-3.68|-7.98|< 0.001
70857514|NCT01931670|141200994|SUPERIORITY||Difference in LS Means|-1.28|STANDARD_ERROR_OF_MEAN|1.264||0.311|TWO_SIDED|95.0|-3.77|1.2|||ANCOVA|||Month 6||1.20|-3.77|0.311
70857515|NCT01931670|141200994|SUPERIORITY||Difference in LS Means|-3.97|STANDARD_ERROR_OF_MEAN|1.241||0.001|TWO_SIDED|95.0|-6.42|-1.53|||ANCOVA|||Month 6||-1.53|-6.42|0.001
70946187|NCT00551135|141392979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4273|TWO_SIDED||||||ANOVA|||CT Distinct CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4273
70946188|NCT00551135|141392979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4466|TWO_SIDED||||||ANOVA|||CT Distinct CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4466
70946189|NCT00551135|141392979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3785|TWO_SIDED||||||ANOVA|||CT Distinct CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3785
70946190|NCT00551135|141392979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2869|TWO_SIDED||||||ANOVA|||CT Distinct CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2869
70946191|NCT00551135|141392979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9905|TWO_SIDED||||||ANOVA|||CT Distinct CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9905
70946192|NCT00551135|141392979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9381|TWO_SIDED||||||ANOVA|||CT Distinct CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9381
70946193|NCT00551135|141392979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2158|TWO_SIDED||||||ANOVA|||CT Distinct CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2158
70946194|NCT00551135|141392979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7887|TWO_SIDED||||||ANOVA|||CT Distinct CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7887
71088320|NCT01687218|141682806|OTHER||Slope|-1.41|||<|0.001|TWO_SIDED|95.0|-1.53|-1.3|||Mixed Models Analysis||This comparison is between the daily rectal and oral (reference) groups for tenofovir levels in blood plasma, log10 ng/mL.|Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||-1.30|-1.53|<0.001
70946195|NCT00551135|141392979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.925|TWO_SIDED||||||ANOVA|||CT Distinct CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9250
70946196|NCT00551135|141392979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1472|TWO_SIDED||||||ANOVA|||CT Distinct CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1472
71088321|NCT01687218|141682806|OTHER||Slope|-1.82|||<|0.001|TWO_SIDED|95.0|-1.95|-1.7|||Mixed Models Analysis||This comparison is between the RAI rectal and oral (reference) groups for tenofovir levels in blood plasma, log10 ng/mL.|Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||-1.70|-1.95|<0.001
70946197|NCT00551135|141392979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5383|TWO_SIDED||||||ANOVA|||CT Distinct CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5383
70946198|NCT00551135|141392979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8869|TWO_SIDED||||||ANOVA|||CT Distinct CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8869
70946199|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4024|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 3 h PS;||||0.4024
70946200|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9766|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 3 h PS;||||0.9766
70946201|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9975|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 3 h PS;||||0.9975
70946202|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9038|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 24 h PS;||||0.9038
70946203|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.937|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 24 h PS;||||0.9370
70946204|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2134|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 24 h PS;||||0.2134
71088322|NCT01687218|141682807|SUPERIORITY||Slope|0.66|||<|0.001|TWO_SIDED|95.0|0.49|0.83|||Mixed Models Analysis||Oral regimen is the reference group.|Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||0.83|0.49|<0.001
71088323|NCT01687218|141682807|SUPERIORITY||Slope|-0.16||||0.31|TWO_SIDED|95.0|-0.46|0.15|||Mixed Models Analysis||Oral regimen is the reference group.|Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||0.15|-0.46|0.31
70946205|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 72 h PS;||||0.2482
70946206|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2207|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 72 h PS;||||0.2207
71088324|NCT01687218|141682808|SUPERIORITY||Slope|0.3||||0.004|TWO_SIDED|95.0|0.1|0.5|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. Mid period and end period visits only were used in this analysis.||0.50|0.10|0.004
71088325|NCT01687218|141682808|SUPERIORITY||Slope|-0.7|||<|0.001|TWO_SIDED|95.0|-0.92|-0.47|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||-0.47|-0.92|<0.001
71088326|NCT01687218|141682809|SUPERIORITY||Slope|-2.66|||<|0.001|TWO_SIDED|95.0|-2.82|-2.5|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality for the following analysis.||-2.50|-2.82|<0.001
70946207|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9191|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 72 h PS;||||0.9191
70946208|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0686|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at EOT;||||0.0686
71088327|NCT01687218|141682809|SUPERIORITY||Slope|-2.65|||<|0.001|TWO_SIDED|95.0|-2.81|-2.49|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality for the following analysis.||-2.49|-2.81|<0.001
71088328|NCT01687218|141682810|SUPERIORITY||Slope|-0.91|||<|0.001|TWO_SIDED|95.0|-1.01|-0.8|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. End period visits only are used in this analysis.||-0.80|-1.01|<0.001
71088329|NCT01687218|141682810|SUPERIORITY||Slope|-0.91|||<|0.001|TWO_SIDED|95.0|-1.01|-0.8|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. End period visits only are used in this analysis.||-0.80|-1.01|<0.001
71125847|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||56.53|TWO_SIDED|95.0|0.77|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.25|0.77|56.53
70946209|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0746|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at EOT;||||0.0746
71125848|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.19||||7.29|TWO_SIDED|95.0|0.94|1.5||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.50|0.94|7.29
70946210|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0512|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at EOT;||||0.0512
70946211|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7118|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 3 h PS;||||0.7118
70857516|NCT01931670|141200995|SUPERIORITY||Difference in LS Means|-0.6|STANDARD_ERROR_OF_MEAN|0.62||0.335|TWO_SIDED|95.0|-1.81|0.62|||ANCOVA|||Month 1||0.62|-1.81|0.335
70946212|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9883|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 3 h PS;||||0.9883
71088330|NCT01687218|141682811|SUPERIORITY||Slope|-2.0|||<|0.001|TWO_SIDED|95.0|-2.16|-1.84|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. Mid period and end period visits only are used in this analysis.||-1.84|-2.16|<0.001
70857517|NCT01931670|141200995|SUPERIORITY||Difference in LS Means|-0.72|STANDARD_ERROR_OF_MEAN|0.611||0.242|TWO_SIDED|95.0|-1.91|0.48|||ANCOVA|||Month 1||0.48|-1.91|0.242
70946213|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.977|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 3 h PS;||||0.9770
70946214|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5457|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 24 h PS;||||0.5457
70946215|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2579|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 24 h PS;||||0.2579
70946216|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1232|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 24 h PS;||||0.1232
70946217|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.288|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 72 h PS;||||0.2880
70857518|NCT01931670|141200995|SUPERIORITY||Difference in LS Means|-1.33|STANDARD_ERROR_OF_MEAN|0.652||0.042|TWO_SIDED|95.0|-2.61|-0.05|||ANCOVA|||Month 2||-0.05|-2.61|0.042
70857519|NCT01931670|141200995|SUPERIORITY||Difference in LS Means|-1.77|STANDARD_ERROR_OF_MEAN|0.656||0.007|TWO_SIDED|95.0|-3.06|-0.48|||ANCOVA|||Month 2||-0.48|-3.06|0.007
70857520|NCT01931670|141200995|SUPERIORITY||Difference in LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.71||0.503|TWO_SIDED|95.0|-1.87|0.92|||ANCOVA|||Month 3||0.92|-1.87|0.503
70857521|NCT01931670|141200995|SUPERIORITY||Difference in LS Means|-0.97|STANDARD_ERROR_OF_MEAN|0.707||0.169|TWO_SIDED|95.0|-2.36|0.41|||ANCOVA|||Month 3||0.41|-2.36|0.169
70946218|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0894|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 72 h PS;||||0.0894
71125849|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||55.09|TWO_SIDED|95.0|0.75|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.28|0.75|55.09
71125850|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.79||||96.49|TWO_SIDED|95.0|0.61|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.61|96.49
71125851|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.13||||14.54|TWO_SIDED|95.0|0.9|1.44||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.44|0.90|14.54
71125852|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.94||||66.85|TWO_SIDED|95.0|0.71|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.25|0.71|66.85
71125853|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.88||||85.77|TWO_SIDED|95.0|0.7|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.70|85.77
71125854|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.24||||8.67|TWO_SIDED|95.0|0.91|1.7||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.70|0.91|8.67
70857522|NCT01931670|141200995|SUPERIORITY||Difference in LS Means|-0.31|STANDARD_ERROR_OF_MEAN|0.737||0.675|TWO_SIDED|95.0|-1.76|1.14|||ANCOVA|||Month 4||1.14|-1.76|0.675
70946219|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1979|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 72 h PS;||||0.1979
71125855|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.22||||14.8|TWO_SIDED|95.0|0.84|1.75||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.75|0.84|14.80
71125856|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||45.69|TWO_SIDED|95.0|0.75|1.37||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.37|0.75|45.69
70857523|NCT01931670|141200995|SUPERIORITY||Difference in LS Means|-2.17|STANDARD_ERROR_OF_MEAN|0.703||0.002|TWO_SIDED|95.0|-3.55|-0.79|||ANCOVA|||Month 4||-0.79|-3.55|0.002
70946220|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0686|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at EOT;||||0.0686
70946221|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0746|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at EOT;||||0.0746
70857524|NCT01931670|141200995|SUPERIORITY||Difference in LS Means|-2.04|STANDARD_ERROR_OF_MEAN|0.856||0.017|TWO_SIDED|95.0|-3.72|-0.36|||ANCOVA|||Month 5||-0.36|-3.72|0.017
70857525|NCT01931670|141200995|SUPERIORITY||Difference in LS Means|-2.54|STANDARD_ERROR_OF_MEAN|0.848||0.003|TWO_SIDED|95.0|-4.21|-0.87|||ANCOVA|||Month 5||-0.87|-4.21|0.003
70946222|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4669|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at EOT;||||0.4669
70857526|NCT01931670|141200995|SUPERIORITY||Difference in LS Means|-1.59|STANDARD_ERROR_OF_MEAN|0.778||0.042|TWO_SIDED|95.0|-3.12|-0.06|||ANCOVA|||Month 6||-0.06|-3.12|0.042
70857527|NCT01931670|141200995|SUPERIORITY||Difference in LS Means|-2.28|STANDARD_ERROR_OF_MEAN|0.738||0.002|TWO_SIDED|95.0|-3.73|-0.83|||ANCOVA|||Month 6||-0.83|-3.73|0.002
70857528|NCT01205581|141201029|SUPERIORITY_OR_OTHER|||||||0.78|||||||Fisher Exact|||||||0.78
70857529|NCT01205581|141201032|SUPERIORITY_OR_OTHER|||||||0.48|||||||Fisher Exact|||||||0.48
70857530|NCT01205581|141201033|SUPERIORITY_OR_OTHER|||||||0.51|||||||Fisher Exact|||||||0.51
70857531|NCT01205581|141201034|SUPERIORITY_OR_OTHER|||||||0.29|||||||Fisher Exact|||||||0.29
70857532|NCT01205581|141201035|SUPERIORITY_OR_OTHER|||||||0.43|||||||Fisher Exact|||||||0.43
70946223|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5533|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 3 h PS;||||0.5533
71125857|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.42||||2.94|TWO_SIDED|95.0|0.99|2.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||2.06|0.99|2.94
71125858|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.22||||13.92|TWO_SIDED|95.0|0.85|1.73||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.73|0.85|13.92
71125859|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.86||||86.4|TWO_SIDED|95.0|0.65|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.65|86.40
71125860|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.46||||0.88|TWO_SIDED|95.0|1.06|2.0||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||2.00|1.06|0.88
70857533|NCT01205581|141201036|SUPERIORITY_OR_OTHER|||||||0.11|||||||Fisher Exact|||||||0.11
70857534|NCT01063712|141201039|SUPERIORITY_OR_OTHER||||||<|0.01|||||||percentage|||It is not a analysis of two groups. Only one group of patients was analyzed.||||<0.01
71125861|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||41.25|TWO_SIDED|95.0|0.75|1.43||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.43|0.75|41.25
71125862|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.7||||99.2|TWO_SIDED|95.0|0.52|0.94||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.94|0.52|99.20
71125863|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.22||||3.49|TWO_SIDED|95.0|0.98|1.51||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; SCRD12 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.51|0.98|3.49
71125864|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.93||||73.09|TWO_SIDED|95.0|0.72|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.72|73.09
71125865|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.85||||92.41|TWO_SIDED|95.0|0.69|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.69|92.41
71125866|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.38||||2.29|TWO_SIDED|95.0|1.01|1.89||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.89|1.01|2.29
71088331|NCT01687218|141682811|SUPERIORITY||Slope|-1.9|||<|0.001|TWO_SIDED|95.0|-2.07|-1.74|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. Mid period and end period visits only are used in this analysis.||-1.74|-2.07|<0.001
71088332|NCT01687218|141682812|SUPERIORITY||Slope|0.54|||<|0.001|TWO_SIDED|95.0|0.35|0.72|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||0.72|0.35|<0.001
71088333|NCT01687218|141682812|SUPERIORITY||Slope|0.01||||0.92|TWO_SIDED|95.0|-0.28|0.31|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||0.31|-0.28|0.92
71088334|NCT01687218|141682813|SUPERIORITY||Odds Ratio (OR)|0.35||||0.0005|TWO_SIDED|95.0|0.19|0.63|||Generalized Estimating Equations (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables was used to compare the three treatment regimens for the acceptability endpoints. Because the distribution of the adherence percentages were skewed, we did not use a linear mixed effects model as originally planned. Instead, we dichotomized the adherence percentage into\<80% adherence versus\>80% adherence.||0.63|0.19|0.0005
71088335|NCT01687218|141682813|SUPERIORITY||Odds Ratio (OR)|0.89||||0.74|TWO_SIDED|95.0|0.43|1.81|||Generalized Estimating Equations (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables was used to compare the three treatment regimens for the acceptability endpoints. Because the distribution of the adherence percentages were skewed, we did not use a linear mixed effects model as originally planned. Instead, we dichotomized the adherence percentage into\<80% adherence versus\>80% adherence.||1.81|0.43|0.74
71088336|NCT02084511|141682825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.39|||||TWO_SIDED|95.0|-76.3|131.1|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||131.1|-76.3|
71088337|NCT02084511|141682825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.48|||||TWO_SIDED|95.0|-50.2|157.1|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||157.1|-50.2|
71088338|NCT02084511|141682825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-174.61|||||TWO_SIDED|95.0|-278.3|-70.9|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||-70.9|-278.3|
71088339|NCT02084511|141682825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-148.53|||||TWO_SIDED|95.0|-252.4|-44.7|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||-44.7|-252.4|
71088340|NCT02084511|141682826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|||||TWO_SIDED|95.0|-2.3|5.7|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||5.7|-2.3|
71088341|NCT02084511|141682826|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.98|||||TWO_SIDED|95.0|-3.0|5.0|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||5.0|-3.0|
71088342|NCT02084511|141682826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.27|||||TWO_SIDED|95.0|-10.3|-2.2|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||-2.2|-10.3|
71088343|NCT02084511|141682826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.98|||||TWO_SIDED|95.0|-11.0|-2.9|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||-2.9|-11.0|
71088344|NCT02084511|141682827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.93|||||TWO_SIDED|95.0|-16.0|27.8|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||27.8|-16.0|
71088345|NCT02084511|141682827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.58|||||TWO_SIDED|95.0|-1.3|42.5|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||42.5|-1.3|
71088346|NCT02084511|141682827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.29|||||TWO_SIDED|95.0|-35.2|8.6|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||8.6|-35.2|
71088347|NCT02084511|141682827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.37|||||TWO_SIDED|95.0|-20.6|23.3|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||23.3|-20.6|
71088348|NCT02084511|141682828|SUPERIORITY_OR_OTHER|||||||0.2503|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.||||0.2503
71088349|NCT02084511|141682828|SUPERIORITY_OR_OTHER|||||||0.1851|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.||||0.1851
70857535|NCT01063712|141201040|SUPERIORITY_OR_OTHER||||||<|0.01|||||||percentage|The analysis was made on the basis of the percentage of patients with completely regressed dilation.||It is a one arm clinical study. No comparison between groups was made.||||<0.01
70857536|NCT03702244|141201070|SUPERIORITY|Statistical testing for recurrent events was performed using the negative binomial methods for recurrent events.|Hazard Ratio (HR)|0.29|||<|0.001|TWO_SIDED|95.0|0.2|0.41|||Log Rank||Hazard ratio was adjusted for age, sex, and coronary artery disease equivalent (diabetes, history of peripheral artery disease or cerebrovascular disease), and intended first test strata (invasive or noninvasive).|Sample size and power calculations for this study are based on the hypothesis that the precision evaluation arm is superior to the usual care arm on the time-to-first event of the composite 3-component endpoint: all-cause death, non-fatal MI, or invasive cardiac catheterization without obstructive CAD over a 12-month of follow-up. Time to event analysis will use the date of the event, including the date of catheterization at which the absence of obstructive CAD is demonstrated.||0.41|0.20|<.001
70946224|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1611|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 3 h PS;||||0.1611
71088350|NCT02084511|141682828|SUPERIORITY_OR_OTHER|||||||0.0167|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.||||0.0167
71088351|NCT02084511|141682829|SUPERIORITY_OR_OTHER|||||||0.415|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.||||0.4150
71088352|NCT02084511|141682829|SUPERIORITY_OR_OTHER|||||||0.3093|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.||||0.3093
71088353|NCT02084511|141682829|SUPERIORITY_OR_OTHER|||||||0.0074|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.||||0.0074
71088354|NCT00944710|141682836|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.0||||0.33|TWO_SIDED|95.0|-10.0|30.0|||Binomial regression|adjusted for visual acuity at randomization||||30|-10|0.33
71088355|NCT00944710|141682841|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.12|TWO_SIDED|95.0|-0.01|0.12|||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.|Positive values favor the Intensified Treatment group|The primary analysis was a treatment group comparison of the masked 10-week amblyopic eye visual acuity using an analysis of covariance (ANCOVA) model, adjusting for visual acuity at randomization. The analysis was a 2-sided test for efficacy to test the null hypothesis of no treatment difference, assuming 90% power and a type I error rate of 5%.||0.12|-0.01|0.12
71088356|NCT00944710|141682849|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.55|TWO_SIDED|95.0|-0.23|0.43|||ANCOVA|||A treatment group difference in fellow-eye visual acuity change at the 12-week exam was evaluated using an ANCOVA model, adjusting for the fellow-eye visual acuity at randomization.||0.43|-0.23|0.55
71088357|NCT00944710|141682858|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The distribution of 12-week Randot Preschool Stereoacuity scores was compared between treatment groups using a Wilcoxon rank sum test.||||0.23
71088358|NCT00944710|141682859|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The distribution of 12-week Randot Preschool Stereoacuity scores was compared between treatment groups using a Wilcoxon rank sum test.||||0.66
71088359|NCT00264147|141682929|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|Cochran-Armitage trend test|A step-down procedure and Abelson-Tukey scaling were used for the trend test.||||||<0.001
71088360|NCT00264147|141682929|SUPERIORITY_OR_OTHER_LEGACY|||||||0.057||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|Cochran-Armitage trend test|A step-down procedure and Abelson-Tukey scaling were used for the trend test.||||||0.057
71088361|NCT00264147|141682929|SUPERIORITY_OR_OTHER_LEGACY||difference in percentage of patients|18.53||||||95.0|7.84|28.65|||||CI based on the Wilson's score method.|||28.65|7.84|
71088362|NCT00264147|141682929|SUPERIORITY_OR_OTHER_LEGACY||difference in percentage of patients|10.0||||||95.0|-0.66|20.46|||||CI based on the Wilson's score method.|||20.46|-0.66|
71088363|NCT00264147|141682929|SUPERIORITY_OR_OTHER_LEGACY||difference in percentage of patients|9.18||||||95.0|-1.25|19.39|||||CI based on the Wilson's score method.|||19.39|-1.25|
71088364|NCT00264147|141682929|SUPERIORITY_OR_OTHER_LEGACY||difference in percentage of patients|6.49||||||95.0|-3.76|16.61|||||CI based on the Wilson's score method.|||16.61|-3.76|
71088365|NCT00264147|141682930|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.002
71088366|NCT00264147|141682930|SUPERIORITY_OR_OTHER_LEGACY|||||||0.221||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.221
71088367|NCT00264147|141682930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.06||||||95.0|-6.44|-1.68||||||||-1.68|-6.44|
71088368|NCT00264147|141682930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.49||||||95.0|-3.91|0.93||||||||0.93|-3.91|
71088369|NCT00264147|141682930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.74||||||95.0|-5.13|-0.35||||||||-0.35|-5.13|
71088370|NCT00264147|141682930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5||||||95.0|-4.88|-0.12||||||||-0.12|-4.88|
71088371|NCT00264147|141682931|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.001
71088372|NCT00264147|141682931|SUPERIORITY_OR_OTHER_LEGACY|||||||0.125||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.125
71088373|NCT00264147|141682931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.24||||||95.0|-3.64|-0.84||||||||-0.84|-3.64|
70946225|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1611|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 3 h PS;||||0.1611
70946226|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4793|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 24 h PS;||||0.4793
70946227|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3533|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 24 h PS;||||0.3533
70946228|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8852|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 24 h PS;||||0.8852
70946229|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 72 h PS;||||0.3173
70946230|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 72 h PS;||||0.3173
70946231|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8864|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 72 h PS;||||0.8864
70946232|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8084|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at EOT;||||0.8084
70946233|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at EOT;||||0.3173
70946234|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2207|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at EOT;||||0.2207
71088374|NCT00264147|141682931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.02||||||95.0|-2.44|0.41||||||||0.41|-2.44|
70946235|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3747|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 3 h PS;||||0.3747
70946236|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.145|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 3 h PS;||||0.1450
71088375|NCT00264147|141682931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.22||||||95.0|-2.63|0.18||||||||0.18|-2.63|
71125867|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.12||||23.67|TWO_SIDED|95.0|0.81|1.56||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters.Unstructured covariance matrix fitted, accounting for correlation within region and visit|TLC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.56|0.81|23.67
71088376|NCT00264147|141682931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49||||||95.0|-1.89|0.91||||||||0.91|-1.89|
71088377|NCT00264147|141682932|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
71125868|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.75||||98.87|TWO_SIDED|95.0|0.59|0.96||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.96|0.59|98.87
71125869|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||14.5|TWO_SIDED|95.0|0.95|1.2||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.20|0.95|14.50
71125870|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||30.26|TWO_SIDED|95.0|0.91|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.18|0.91|30.26
71125871|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||62.84|TWO_SIDED|95.0|0.89|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region Central; D12D28 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.09|0.89|62.84
71125872|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.31||||2.06|TWO_SIDED|95.0|1.01|1.7||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.70|1.01|2.06
70946237|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2054|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 3 h PS;||||0.2054
71088378|NCT00264147|141682932|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
71088379|NCT00264147|141682932|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
71125873|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||49.97|TWO_SIDED|95.0|0.76|1.32||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.32|0.76|49.97
71125874|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.76||||99.43|TWO_SIDED|95.0|0.62|0.94||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.94|0.62|99.43
71125875|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.2||||1.17|TWO_SIDED|95.0|1.02|1.41||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.41|1.02|1.17
71125876|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||49.78|TWO_SIDED|95.0|0.84|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.18|0.84|49.78
71125877|NCT02294734|141757730|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.85||||98.66|TWO_SIDED|95.0|0.73|0.98||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.98|0.73|98.66
71125878|NCT02294734|141757731|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||32.51|TWO_SIDED|95.0|0.97|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RUL; Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.97|32.51
71125879|NCT02294734|141757731|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||6.21|TWO_SIDED|95.0|0.99|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RUL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.99|6.21
71125880|NCT02294734|141757731|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||15.91|TWO_SIDED|95.0|0.98|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; LUL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.98|15.91
71125881|NCT02294734|141757731|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||6.73|TWO_SIDED|95.0|0.99|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes;LUL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.09|0.99|6.73
70946238|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4106|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 24 h PS;||||0.4106
71088380|NCT00264147|141682932|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.023
71088381|NCT00264147|141682932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.16||||||95.0|-19.38|-8.95||||||||-8.95|-19.38|
71088382|NCT00264147|141682932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.21||||||95.0|-14.52|-3.9||||||||-3.90|-14.52|
71088383|NCT00264147|141682932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.87||||||95.0|-14.11|-3.63||||||||-3.63|-14.11|
71088384|NCT00264147|141682932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.05||||||95.0|-11.27|-0.83||||||||-0.83|-11.27|
71088385|NCT00264147|141682933|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
71088386|NCT00264147|141682933|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
71088387|NCT00264147|141682933|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
71088388|NCT00264147|141682933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.018
71088389|NCT00264147|141682933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56||||||95.0|-0.77|-0.35||||||||-0.35|-0.77|
71088390|NCT00264147|141682933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.34||||||95.0|-0.55|-0.13||||||||-0.13|-0.55|
71088391|NCT00264147|141682933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||||95.0|-0.61|-0.19||||||||-0.19|-0.61|
71088392|NCT00264147|141682933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25||||||95.0|-0.46|-0.04||||||||-0.04|-0.46|
71088393|NCT00264147|141682934|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
71088394|NCT00264147|141682934|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.018
71088395|NCT00264147|141682934|SUPERIORITY_OR_OTHER_LEGACY|||||||0.017||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.017
71088396|NCT00264147|141682934|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.080
71088397|NCT00264147|141682934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.44||||||95.0|-19.62|-9.26||||||||-9.26|-19.62|
71088398|NCT00264147|141682934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.22||||||95.0|-11.52|-0.92||||||||-0.92|-11.52|
71088399|NCT00264147|141682934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.32||||||95.0|-11.53|-1.12||||||||-1.12|-11.53|
71088400|NCT00264147|141682934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.63||||||95.0|-9.81|0.55||||||||0.55|-9.81|
71125882|NCT02294734|141757731|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||27.65|TWO_SIDED|95.0|0.96|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RML Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.96|27.65
71088401|NCT02008526|141682948|SUPERIORITY||F|1.16||||0.3137|TWO_SIDED||||||ANOVA|2 Degrees of Freedom||||||0.3137
71088402|NCT02008526|141682949|SUPERIORITY||F|0.16||||0.8494|TWO_SIDED||||||ANOVA|2 Degrees of Freedom||||||0.8494
71088403|NCT00492726|141682961|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set to 10% in the protocol, in agreement with FDA recommendations. Sample size was estimated using the method as described in Farrington-Manning. Estimation was performed to achieve 85% power, based on the equivalence delta of 10%, and a clinical success rate of 80% in the per protocol population.|Difference of cure rates (in percent)|-3.8||||||95.0|-7.9|0.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||0.4|-7.9|
71088404|NCT00492726|141682962|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference in improvement rates (in %)|1.1||||||95.0|-0.4|2.7|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||2.7|-0.4|
71088405|NCT00492726|141682963|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference in bact. success rates (in %)|-3.9||||||95.0|-8.8|1.0|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group. Presumed eradications and eradications without superinfection were considered bacteriological successes.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||1.0|-8.8|
71088406|NCT00492726|141682964|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of cure rates (in percent)|-1.5||||||95.0|-5.0|1.9|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||1.9|-5.0|
71088407|NCT00492726|141682965|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference in bact. success rates (in %)|-3.9||||||95.0|-8.8|1.0|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group. Presumed eradications and eradications without superinfection were considered bacteriological successes.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||1.0|-8.8|
71088408|NCT00492726|141682966|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference in bact. success rates (in %)|-3.8||||||95.0|-9.0|1.5|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group. Presumed eradications and eradications without super- or reinfection were considered bacteriological successes.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||1.5|-9.0|
71088409|NCT00492726|141682967|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of cure rates (in percent)|-2.9||||||95.0|-7.6|1.9|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||1.9|-7.6|
71088410|NCT05994963|141682985|OTHER||Ratio of adjusted geometric means|58.84|||||TWO_SIDED|90.0|40.45|85.6|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment A = reference; treatment B = test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||85.60|40.45|
71088411|NCT05994963|141682986|OTHER||Ratio of adjusted geometric means|56.93|||||TWO_SIDED|90.0|38.71|83.73|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment A = reference; treatment B = test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||83.73|38.71|
71088412|NCT05994963|141682987|OTHER||Ratio of adjusted geometric means|50.13|||||TWO_SIDED|90.0|33.01|76.13|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment A = reference; treatment B = test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||76.13|33.01|
71088413|NCT05994963|141682988|OTHER||Ratio of adjusted geometric means|202.52|||||TWO_SIDED|90.0|138.43|296.27|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment B = reference; treatment C = test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||296.27|138.43|
71088414|NCT05994963|141682989|OTHER||Ratio of adjusted geometric means|196.11|||||TWO_SIDED|90.0|131.01|293.55|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment B = reference; treatment C = test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||293.55|131.01|
71125883|NCT02294734|141757731|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||12.19|TWO_SIDED|95.0|0.98|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RML Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.98|12.19
71125884|NCT02294734|141757731|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||11.62|TWO_SIDED|95.0|0.98|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RLL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.10|0.98|11.62
71125885|NCT02294734|141757731|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||7.66|TWO_SIDED|95.0|0.99|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RLL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.10|0.99|7.66
71088415|NCT05994963|141682990|OTHER||Ratio of adjusted geometric means|230.22|||||TWO_SIDED|90.0|145.53|364.2|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment B = reference; treatment C = test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||364.20|145.53|
71088416|NCT05994963|141682991|OTHER||Ratio of adjusted geometric means|122.84|||||TWO_SIDED|90.0|93.61|161.19|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment B = reference; treatment D= test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||161.19|93.61|
71088417|NCT05994963|141682992|OTHER||Ratio of adjusted geometric means|104.69|||||TWO_SIDED|90.0|94.54|115.94|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment B = reference; treatment D= test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||115.94|94.54|
71088418|NCT05994963|141682993|OTHER||Ratio of adjusted geometric means|124.59|||||TWO_SIDED|90.0|93.46|166.09|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment B = reference; treatment D= test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||166.09|93.46|
71125886|NCT02294734|141757731|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||28.88|TWO_SIDED|95.0|0.96|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; LLL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.96|28.88
71088419|NCT03141359|141683002|SUPERIORITY||Rate|0.627||||0.388|TWO_SIDED|95.0|0.492|0.75|||Fisher Exact||Confidence interval estimated using the Clopper Pearson method.|We used a single-stage design to test null hypothesis (H0) that 1-yr PFS is \<= 0.60. Assuming one-sided α= 0.10, 60 patients provided 98% power to reject H0, assuming the true 1-yr PFS is 0.80. Since not all enrolled subjects received durva, study power was affected. For patients who did not receive durva, H0 was assumed to be 0.40 versus an alternative of 0.60. Including these subjects reduced power from 98%. The conditional power given that 13 evaluable subjects didn't receive durva was 88%.||0.750|0.492|.388
71088420|NCT03141359|141683005|OTHER|Estimation only|Rate|0.571|||||TWO_SIDED|95.0|0.422|0.712|||||Confidence interval estimated using the Clopper Pearson method.|||0.712|0.422|
71088421|NCT03141359|141683006|OTHER|Estimation only|Rate|0.75|||||TWO_SIDED|95.0|0.621|0.853|||||Confidence interval estimated using the Clopper Pearson method.|||0.853|0.621|
71088422|NCT03141359|141683014|OTHER|Estimation only|Rate|0.164|||||TWO_SIDED|95.0|0.082|0.281|||||Confidence interval estimated using the Clopper Pearson method.|||0.281|0.082|
71088423|NCT03141359|141683015|OTHER|Estimation only|Rate|0.246|||||TWO_SIDED|95.0|0.145|0.373|||||Confidence interval estimated using the Clopper Pearson method.|||0.373|0.145|
71088424|NCT01081626|141683021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0135||||0.956|TWO_SIDED|95.0|-0.1325|0.1637|||Chi-squared, Corrected|||||0.1637|-0.1325|0.9560
71088425|NCT01081626|141683022|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.088||||0.7924|TWO_SIDED|95.0|0.7642|1.549|||Chi-squared|||||1.5490|0.7642|0.7924
71088426|NCT01081626|141683026|SUPERIORITY_OR_OTHER|||||||0.5331||95.0|||||Chi-squared|||||||0.5331
71088427|NCT01081626|141683027|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.015||||0.9351|TWO_SIDED|95.0|0.7175|1.435|||Chi-squared|||||1.4350|0.7175|0.9351
71088428|NCT00720278|141683042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|STANDARD_DEVIATION|0.47|<|0.001||95.0|-2.98|-1.14|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14||-1.14|-2.98|<0.001
71125887|NCT02294734|141757731|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||28.28|TWO_SIDED|95.0|0.96|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; LLL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.96|28.28
71088429|NCT00720278|141683042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|0.465|<|0.001||95.0|-3.91|-2.09|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14||-2.09|-3.91|<0.001
71088430|NCT00720278|141683043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.78|STANDARD_DEVIATION|0.479|<|0.001||95.0|-2.72|-0.84|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14||-0.84|-2.72|<0.001
71088431|NCT00720278|141683043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.668|STANDARD_DEVIATION|0.4735|<|0.001||95.0|-3.6|-1.74|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14||-1.74|-3.60|<0.001
71088432|NCT00720278|141683044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.376|STANDARD_DEVIATION|0.418||0.001||95.0|-2.2|-0.56|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14||-0.56|-2.20|0.001
71088433|NCT00720278|141683044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.432|STANDARD_DEVIATION|0.4145|<|0.001||95.0|-3.24|-1.62|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14||-1.62|-3.24|<0.001
71088434|NCT01181167|141683060|NON_INFERIORITY_OR_EQUIVALENCE|"Difference in incidence of thromboembolic events between DU-176b and enoxaparin groups and 95% confidence interval (CI) were calculated.~Incidence of thromboembolic events and 95% CI also calculated by treatment group.~Only when null hypothesis H01 was rejected, upper limit of 95% CI for difference between DU-176b and enoxaparin groups was confirmed. When upper limit of 95% CI was below 0%, DU-176b was considered to be superior to enoxaparin in terms of the prevention of VTE."|Cox Proportional Hazard|-4.5|||<|0.001|ONE_SIDED|95.0||||Farrington Manning Method|ANCOVA|||Hypothesis testing of proportion of subjects who experienced at least one thromboembolic events, defined as primary endpoint, carried out using Farrington-Manning method. Null hypothesis H˅01: Incidence of thromboembolic events in DU-176b group (P˅DU) = Incidence of thromboembolic events in enoxaparin group (P˅E) + Δ (8%). Alternative hypothesis H˅11: P˅DU \< P˅E + Δ (significance level: One-sided, 0.025)||||<0.001
71088435|NCT00408499|141683087|OTHER|Maximum tolerated dose was derived from toxicity data obtained from dose level 1-4.|Maximum tolerated dose|4.0|||||TWO_SIDED||||||||Maximum tolerated dose was determined to be dose level 4: 150 mg Erlotinib, 250 mg/m2 Cetuximab|||||
71088436|NCT02683109|141683106|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the Tio+Olo FDC versus the Tio/Olo free combination was tested at the one-sided α-level of 0.025 using a non-inferiority margin of 0.1 L.|Adjusted mean|0.024|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|-0.02|0.067|||ANCOVA|||The primary analysis was conducted using an Analysis of Covariance \[ANCOVA\] model including treatment as fixed categorical effect and baseline as continuous covariate.||0.067|-0.020|<0.0001
71088437|NCT02683109|141683107|SUPERIORITY_OR_OTHER||Adjusted mean|0.006|STANDARD_ERROR_OF_MEAN|0.034||0.8648|TWO_SIDED|95.0|-0.061|0.073|||ANCOVA|||The secondary analysis was conducted using an ANCOVA model including treatment as fixed categorical effect and baseline as continuous covariate.||0.073|-0.061|0.8648
71088438|NCT02683109|141683108|SUPERIORITY_OR_OTHER||Adjusted mean|-0.327|STANDARD_ERROR_OF_MEAN|0.536||0.542|TWO_SIDED|95.0|-1.384|0.729|||ANCOVA|||The secondary analysis was conducted using an ANCOVA model including treatment as fixed categorical effect and baseline as continuous covariate.||0.729|-1.384|0.5420
71088439|NCT00526474|141683157|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.001|TWO_SIDED|95.0|0.82|0.95|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.95|0.82|0.001
70857537|NCT01895361|141201125|OTHER||Hodges-Lehmann median absolute diff.|-1.01|||=|0.01|TWO_SIDED|95.0|-2.0|0.0|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crisis history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata.||||0.00|-2.00|= 0.010
70857538|NCT01895361|141201125|OTHER||Hodges-Lehmann median absolute diff.|-0.69|||=|0.18|TWO_SIDED|95.0|-1.84|0.02|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata.||||0.02|-1.84|= 0.180
70857539|NCT01895361|141201126|OTHER||Change vs placebo (%)|-45.3|||||ONE_SIDED|||||||||||||
71088440|NCT00526474|141683158|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.87|||<|0.001|TWO_SIDED|95.0|0.8|0.94|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.94|0.80|<0.001
71088441|NCT00526474|141683159|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.51|||<|0.001|TWO_SIDED|95.0|1.31|1.74|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.74|1.31|<0.001
71088442|NCT00526474|141683160|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.41|||<|0.001|TWO_SIDED|95.0|1.31|1.51|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.51|1.31|<0.001
71088443|NCT00526474|141683161|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.91||||0.009|TWO_SIDED|95.0|0.85|0.98|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.98|0.85|0.009
71088444|NCT00526474|141683162|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86||||0.002|TWO_SIDED|95.0|0.78|0.94|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.94|0.78|0.002
71088445|NCT00526474|141683163|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.87|||<|0.001|TWO_SIDED|95.0|0.81|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.93|0.81|<0.001
71088446|NCT00526474|141683164|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.91||||0.001|TWO_SIDED|95.0|0.86|0.96|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.96|0.86|0.001
71088447|NCT00526474|141683165|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9|||<|0.001|TWO_SIDED|95.0|0.85|0.95|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.95|0.85|<0.001
71088448|NCT00526474|141683166|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.89||||0.151|TWO_SIDED|95.0|0.76|1.04|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.04|0.76|0.151
71088449|NCT00526474|141683167|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83||||0.001|TWO_SIDED|95.0|0.74|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.93|0.74|0.001
71125888|NCT02294734|141757731|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||27.87|TWO_SIDED|95.0|0.97|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Region; Upper Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.97|27.87
70857540|NCT01895361|141201126|OTHER||Change vs placebo (%)|-32.6|||||ONE_SIDED|||||||||||||
70857541|NCT01895361|141201127|OTHER||Hodges-Lehmann median absolute diff.|0.0|||=|0.45|TWO_SIDED|95.0|-4.36|0.0|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata.||||0.00|-4.36|= 0.450
70857542|NCT01895361|141201127|OTHER||Hodges-Lehmann median absolute diff.|0.0|||=|0.837|TWO_SIDED|95.0|-3.9|2.61|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata.||||2.61|-3.90|= 0.837
70857543|NCT01895361|141201128|OTHER||Hazard Ratio (HR)|0.495|||=|0.001|TWO_SIDED|95.0|0.331|0.741|||Log Rank||Calculated based on Cox regression analysis with HU therapy (yes, no), categorized crises history (2 to 4, 5 to 10), and treatment as covariates|||0.741|0.331|= 0.001
70857544|NCT01895361|141201128|OTHER||Hazard Ratio (HR)|0.752|||=|0.136|TWO_SIDED|95.0|0.515|1.097|||Log Rank||Calculated based on Cox regression analysis with HU therapy (yes, no), categorized crises history (2 to 4, 5 to 10), and treatment as covariates|||1.097|0.515|= 0.136
70946239|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2199|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 24 h PS;||||0.2199
71088450|NCT00526474|141683168|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.108|TWO_SIDED|95.0|0.75|1.03|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.03|0.75|0.108
71125889|NCT02294734|141757731|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||9.83|TWO_SIDED|95.0|0.99|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.No|FRC Region; Upper Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.99|9.83
71125890|NCT02294734|141757731|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||21.87|TWO_SIDED|95.0|0.97|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Region; Lower Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.97|21.87
71125891|NCT02294734|141757731|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||18.58|TWO_SIDED|95.0|0.97|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Region; Lower Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.97|18.58
71125892|NCT02294734|141757731|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||22.28|TWO_SIDED|95.0|0.98|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Region; Total Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.98|22.28
71125893|NCT02294734|141757731|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||10.86|TWO_SIDED|95.0|0.98|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Region; Total Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.98|10.86
71125894|NCT02294734|141757731|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||84.89|TWO_SIDED|95.0|0.97|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RUL; Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.97|84.89
71125895|NCT02294734|141757731|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||63.78|TWO_SIDED|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RUL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.97|63.78
71125896|NCT02294734|141757731|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||69.42|TWO_SIDED|95.0|0.98|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; LUL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.98|69.42
71125897|NCT02294734|141757731|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||62.63|TWO_SIDED|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes;LUL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.97|62.63
71125898|NCT02294734|141757731|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||72.55|TWO_SIDED|95.0|0.96|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RML Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.96|72.55
71125899|NCT02294734|141757731|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||36.28|TWO_SIDED|95.0|0.97|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RML Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.97|36.28
70946240|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2896|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 24 h PS;||||0.2896
71088451|NCT00526474|141683169|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.97||||0.733|TWO_SIDED|95.0|0.83|1.14|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.14|0.83|0.733
71125900|NCT02294734|141757731|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||47.44|TWO_SIDED|95.0|0.96|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RLL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.96|47.44
71125901|NCT02294734|141757731|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||22.99|TWO_SIDED|95.0|0.97|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RLL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.97|22.99
71088452|NCT00526474|141683170|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.95||||0.411|TWO_SIDED|95.0|0.85|1.07|||Cox Proportional Hazards Regression||Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.07|0.85|0.411
71088453|NCT00526474|141683171|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83||||0.001|TWO_SIDED|95.0|0.74|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.93|0.74|0.001
71088454|NCT00526474|141683172|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.89|||<|0.001|TWO_SIDED|95.0|0.83|0.95|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.95|0.83|<0.001
71088455|NCT00526474|141683173|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83|||<|0.001|TWO_SIDED|95.0|0.76|0.9|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.90|0.76|<0.001
71088456|NCT00526474|141683174|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8|||<|0.001|TWO_SIDED|95.0|0.73|0.89|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.89|0.73|<0.001
71088457|NCT00526474|141683175|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.45|||<|0.001|TWO_SIDED|95.0|1.23|1.71|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.71|1.23|<0.001
71088458|NCT00526474|141683176|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.42|||<|0.001|TWO_SIDED|95.0|1.31|1.54|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.54|1.31|<0.001
71088459|NCT00526474|141683177|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86|||<|0.001|TWO_SIDED|95.0|0.79|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.93|0.79|<0.001
71088460|NCT00526474|141683178|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83|||<|0.001|TWO_SIDED|95.0|0.75|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.93|0.75|<0.001
71088461|NCT00526474|141683179|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83|||<|0.001|TWO_SIDED|95.0|0.77|0.9|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.90|0.77|<0.001
71088462|NCT00526474|141683180|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.89|||<|0.001|TWO_SIDED|95.0|0.83|0.95|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.95|0.83|<0.001
70857545|NCT01895361|141201129|OTHER||Hazard Ratio (HR)|0.534|||=|0.022|TWO_SIDED|95.0|0.329|0.866|||Log Rank||Calculated based on Cox regression analysis with HU therapy (yes, no), categorized crises history (2 to 4, 5 to 10), and treatment as covariates|||0.866|0.329|= 0.022
70857546|NCT01895361|141201129|OTHER||Hazard Ratio (HR)|0.693|||=|0.1|TWO_SIDED|95.0|0.44|1.092|||Log Rank||Calculated based on Cox regression analysis with HU therapy (yes, no), categorized crises history (2 to 4, 5 to 10), and treatment as covariates|||1.092|0.440|= 0.100
70857547|NCT01895361|141201130|OTHER||Hodges-Lehmann median absolute diff.|-1.0|||=|0.015|TWO_SIDED|95.0|-1.98|0.0|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata||||0.00|-1.98|= 0.015
70857548|NCT01895361|141201130|OTHER||Hodges-Lehmann median absolute diff.|-0.87|||=|0.12|TWO_SIDED|95.0|-1.77|0.0|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata||||0.00|-1.77|= 0.120
70857549|NCT01895361|141201131|OTHER||Hodges-Lehmann median absolute diff.|0.0|||=|0.78|TWO_SIDED|95.0|0.0|0.0|||Stratified Wilcoxon Rank Sum test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata||||0.00|0.00|= 0.780
70946241|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at EOT;||||1.0000
70946242|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at EOT;||||0.3173
70946243|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3943|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at EOT;||||0.3943
71088463|NCT00526474|141683181|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88|||<|0.001|TWO_SIDED|95.0|0.83|0.94|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.94|0.83|<0.001
71088464|NCT00526474|141683182|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86||||0.108|TWO_SIDED|95.0|0.71|1.03|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.03|0.71|0.108
71088465|NCT00526474|141683183|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.82||||0.002|TWO_SIDED|95.0|0.73|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.93|0.73|0.002
71125902|NCT02294734|141757731|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||85.95|TWO_SIDED|95.0|0.94|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; LLL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.94|85.95
71088466|NCT00526474|141683184|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.127|TWO_SIDED|95.0|0.74|1.04|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.04|0.74|0.127
71088467|NCT00526474|141683185|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.67||||0.002|TWO_SIDED|95.0|0.52|0.87|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.87|0.52|0.002
70857550|NCT01895361|141201131|OTHER||Hodges-Lehmann median absolute diff.|0.0|||=|0.868|TWO_SIDED|95.0|0.0|0.0|||Stratified Wilcoxon Rank Sum test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata.||||0.00|0.00|= 0.868
70946244|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1703|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 3 h PS;||||0.1703
70946245|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0807|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 3 h PS;||||0.0807
70857551|NCT02692651|141201148|SUPERIORITY|||||||0.195|||||||Chi-squared, Corrected|||||||0.195
70857552|NCT02692651|141201149|SUPERIORITY|||||||0.99|||||||Chi-squared, Corrected|||||||.99
70857553|NCT02692651|141201150|SUPERIORITY|||||||0.999|||||||Chi-squared, Corrected|||||||.999
70857554|NCT02239120|141201159|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.1028|TWO_SIDED|95.0|0.69|1.03|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.03|0.69|0.1028
70857555|NCT02239120|141201160|SUPERIORITY||Hazard Ratio (HR)|1.36||||0.1076|TWO_SIDED|95.0|0.94|1.97|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.97|0.94|0.1076
71088468|NCT00526474|141683186|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.92||||0.249|TWO_SIDED|95.0|0.8|1.06|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.06|0.80|0.249
71125903|NCT02294734|141757731|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||60.2|TWO_SIDED|95.0|0.96|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; LLL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.96|60.20
70857556|NCT02239120|141201161|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0892|TWO_SIDED|95.0|0.68|1.03|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.03|0.68|0.0892
70857557|NCT02239120|141201162|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1911|TWO_SIDED|95.0|0.73|1.06|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.06|0.73|0.1911
71088469|NCT00526474|141683187|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86||||0.019|TWO_SIDED|95.0|0.76|0.98|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.98|0.76|0.019
71088470|NCT00526474|141683188|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.89||||0.003|TWO_SIDED|95.0|0.83|0.96|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.96|0.83|0.003
71088471|NCT03845894|141683189|NON_INFERIORITY|There have been no studies to evaluate pain scores ISB w/ plain bupi+adjuvants. Power to detect difference at least 0.4 on the VAS scale. Threshold for inferiority is difference \>=2 points on the VAS scale. Will use two-sample t test with α= 0.05 and β= 0.1. Postop opioid consumption, total post-op opioid @ 1st 48 hours in oxycodone equivalents. Mean opioid consumption per cohort is calculated, \& the cohorts compared for statistical difference with two-sample t test, with α= 0.05 and β= 0.1.||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
71088472|NCT01450813|141683197|NON_INFERIORITY_OR_EQUIVALENCE|Sample size needed for a one-way ANOVA test with an alpha of 0.05 and power of 0.8 to rule out the null hypothesis that neuromuscular blocking drugs have no effect on CVI with 95% confidence was a total of 64 or 16 per Group.|||||<|0.05||||||Comparisons of the means were accomplished via student's t-test with Bonferroni correction for multiple comparisons.|ANOVA|||Null hypothesis that neuromuscular blocking drugs have no effect on CVI with 95% confidence.||||< 0.05
71088473|NCT02709746|141683199|SUPERIORITY||Mean Difference (Final Values)|1.13||||0.4702|TWO_SIDED|95.0|-1.94|4.2|||Mixed Model Repeated Analysis|||||4.2|-1.94|0.4702
71088474|NCT02709746|141683199|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.6373|TWO_SIDED|95.0|-3.71|2.27|||Mixed Model Repeated Analysis|||||2.27|-3.71|0.6373
71088475|NCT02709746|141683199|SUPERIORITY||Mean Difference (Final Values)|-3.73||||0.0152|TWO_SIDED|95.0|-6.74|-0.72|||Mixed Model Repeated Analysis|||||-0.72|-6.74|0.0152
71088476|NCT02709746|141683199|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.8778|TWO_SIDED|95.0|-2.41|2.82|||Mixed Model Repeated Analysis|||||2.82|-2.41|0.8778
71088477|NCT03073486|141683227|OTHER|||||||0.2301|||||||ANCOVA|Ranked ANCOVA, Markov Chain Monte Carlo (MCMC) Multiple Imputation||||||0.2301
71088478|NCT03073486|141683228|OTHER|||||||0.6888|||||||ANCOVA|Ranked ANCOVA, Markov Chain Monte Carlo (MCMC) Multiple Imputation||||||0.6888
71088479|NCT03073486|141683229|OTHER|||||||0.1361|||||||Regression, Logistic|Logistic Regression (Firth's Penalized Likelihood), MCMC Multiple Imputation||||||0.1361
71088480|NCT02089347|141683240|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is supported by a data if the lower bound of the two-sided 95% confidence interval (CI) is greater than -10%|Wilson score method|1.42|||||TWO_SIDED|95.0|-0.31|4.61||||||Non-inferiority comparison of post-booster response for Diphtheria.||4.61|-0.31|
71088481|NCT02089347|141683240|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is supported by the data if lower bound ot the two-sided 95% is greater than -10%|Wilson score method|6.25|||||TWO_SIDED|95.0|3.32|10.84||||||Non-inferiority comparison of post-vaccination booster response for tetanus||10.84|3.32|
71088482|NCT02089347|141683241|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is supported by a data if the lower bound of the two-sided 95% confidence interval (CI) is greater than -10%|Wilson score method|0.57|||||TWO_SIDED|95.0|-0.61|3.15||||||Non-inferiority comparison of Diphtheria post-vaccination seroprotection rates at ≥ 0.1 IU/mL||3.15|-0.61|
71088483|NCT02089347|141683241|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is supported by a data if the lower bound of the two-sided 95% confidence interval (CI) is greater than -10%.|Wilson score method|0.0|||||TWO_SIDED|95.0|-1.09|2.14||||||Non-inferiority comparison of Tetanus post-vaccination seroprotection rates at ≥ 0.1 IU/mL||2.14|-1.09|
71088484|NCT00644059|141683300|SUPERIORITY_OR_OTHER||Vaccine Efficacy|81.36|||||TWO_SIDED|97.66|49.24|93.16|||Poisson Regression Model|||"Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the population average incidence of influenza.~Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)"||93.16|49.24|
71088485|NCT00644059|141683303|SUPERIORITY_OR_OTHER||Vaccine Efficacy|81.36|||||TWO_SIDED|95.0|49.24|93.16|||Poisson Regression Model|||"Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the incidence of influenza.~Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)"||93.16|49.24|
71088486|NCT00644059|141683303|SUPERIORITY_OR_OTHER||Vaccine Efficacy|95.5|||||TWO_SIDED|95.0|80.92|98.94|||Poisson Regression Model|||"Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the incidence of influenza.~Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)"||98.94|80.92|
71125904|NCT02294734|141757731|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||81.34|TWO_SIDED|95.0|0.97|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Upper Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.97|81.34
71125905|NCT02294734|141757731|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||63.04|TWO_SIDED|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC UpperDay 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.97|63.04
71125906|NCT02294734|141757731|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||69.67|TWO_SIDED|95.0|0.96|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lower Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.96|69.67
71125907|NCT02294734|141757731|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||39.81|TWO_SIDED|95.0|0.97|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lower Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.97|39.81
71125908|NCT02294734|141757731|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||73.01|TWO_SIDED|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Total Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.97|73.01
71125909|NCT02294734|141757731|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||48.97|TWO_SIDED|95.0|0.97|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Total Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.97|48.97
71125910|NCT02294734|141757732|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||2.89|TWO_SIDED|95.0|1.0|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Length Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|1.00|2.89
71125911|NCT02294734|141757732|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||8.49|TWO_SIDED|95.0|0.99|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Length Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.99|8.49
71088487|NCT00644059|141683303|SUPERIORITY_OR_OTHER||Vaccine Efficacy|0.32|||||TWO_SIDED|95.0|0.13|0.73|||Mantel Haenszel|||Relative efficacy for TIV-adj was to be calculated as VE = (1-Itest/Ictrl)100%, where I is the incidence of influenza, i.e. percentage of subjects with virus-confirmed symptomatic influenza A or B illness, in the investigational agent (TIV-adj) group or in the flu vaccine control group.||0.73|0.13|
71088488|NCT00644059|141683303|SUPERIORITY_OR_OTHER||Vaccine Efficacy|0.09|||||TWO_SIDED|95.0|0.02|0.38|||Mantel Haenszel|||Relative efficacy for TIV-adj was to be calculated as VE = (1-Itest/Ictrl)100%, where I is the incidence of influenza, i.e. percentage of subjects with virus-confirmed symptomatic influenza A or B illness, in the investigational agent (TIV-adj) group or in the flu vaccine control group.||0.38|0.02|
70857558|NCT02239120|141201163|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.0354|TWO_SIDED|95.0|0.36|0.96|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||0.96|0.36|0.0354
71088489|NCT00644059|141683304|SUPERIORITY_OR_OTHER||vaccine Efficacy|79.18|||||TWO_SIDED|95.0|54.78|90.42|||Poisson Regression Model|||"Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the population average incidence of influenza.~Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)"||90.42|54.78|
70857559|NCT02239120|141201164|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.8074|TWO_SIDED|95.0|0.66|1.38|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.38|0.66|0.8074
70857560|NCT02239120|141201165|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.9064|TWO_SIDED|95.0|0.58|1.83|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.83|0.58|0.9064
71088490|NCT00644059|141683304|SUPERIORITY_OR_OTHER||Vaccine Efficacy|92.1|||||TWO_SIDED|95.0|77.35|97.24|||Poisson Regression Model|||Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the incidence of influenza. Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)||97.24|77.35|
71088491|NCT00644059|141683304|SUPERIORITY_OR_OTHER||Vaccine Efficacy|64.16|||||TWO_SIDED|95.0|23.21|83.28|||Poisson Regression Model|||Relative efficacy for TIV-adj was to be calculated as VE = (1-Itest/Ictrl)100%, where I is the incidence of influenza, i.e. percentage of subjects with virus-confirmed symptomatic influenza A or B illness, in the investigational agent (TIV-adj) group or in the flu vaccine control group.||83.28|23.21|
71088492|NCT00644059|141683304|SUPERIORITY_OR_OTHER||Vaccine Efficacy|85.66|||||TWO_SIDED|95.0|58.95|94.99|||Poisson Regression Model|||Relative efficacy for TIV-adj was to be calculated as VE = (1-Itest/Ictrl)100%, where I is the incidence of influenza, i.e. percentage of subjects with virus-confirmed symptomatic influenza A or B illness, in the investigational agent (TIV-adj) group or in the flu vaccine control group.||94.99|58.95|
71088493|NCT00644059|141683310|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H1N1)]|0.83|||||TWO_SIDED|95.0|0.67|1.02|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.02|0.67|
71088494|NCT00644059|141683310|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H1N1)]|7.63|||||TWO_SIDED|95.0|5.42|11.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||11|5.42|
71088495|NCT00644059|141683310|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H1N1)]|15.0|||||TWO_SIDED|95.0|11.0|21.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay||21|11|
71088496|NCT00644059|141683310|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H1N1)]|6.48|||||TWO_SIDED|95.0|4.83|8.68|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay||8.68|4.83|
71088497|NCT00644059|141683310|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H3N2)]|1.01|||||TWO_SIDED|95.0|0.85|1.21|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.21|0.85|
71088498|NCT00644059|141683310|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H3N2)]|9.82|||||TWO_SIDED|95.0|7.76|12.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||12|7.76|
71088499|NCT00644059|141683310|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H3N2)]|16.0|||||TWO_SIDED|95.0|12.0|20.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||20|12|
71088500|NCT00644059|141683310|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H3N2)]|4.92|||||TWO_SIDED|95.0|3.64|6.65|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||6.65|3.64|
71088501|NCT00644059|141683310|SUPERIORITY_OR_OTHER||GMT[B/Florida/2006]|1.0|||||TWO_SIDED|95.0|0.91|1.1|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.1|0.91|
71088502|NCT00644059|141683310|SUPERIORITY_OR_OTHER||GMT[B/Florida/2006]|1.5|||||TWO_SIDED|95.0|1.19|1.9|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.9|1.19|
71088503|NCT00644059|141683310|SUPERIORITY_OR_OTHER||GMT[B/Florida/2006]|6.99|||||TWO_SIDED|95.0|5.72|8.53|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||8.53|5.72|
71088504|NCT00644059|141683310|SUPERIORITY_OR_OTHER||GMT[B/Florida/2006]|2.92|||||TWO_SIDED|95.0|2.44|3.5|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||3.5|2.44|
71088505|NCT00644059|141683310|SUPERIORITY_OR_OTHER||GMT [A/Solomon Islands/2006 (A/H1N1)]|0.81|||||TWO_SIDED|95.0|0.64|1.04|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.04|0.64|
70946246|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7728|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 3 h PS;||||0.7728
71125912|NCT02294734|141757732|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||86.21|TWO_SIDED|95.0|0.98|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Diameter Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.98|86.21
71125913|NCT02294734|141757732|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||75.2|TWO_SIDED|95.0|0.98|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Diameter Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.98|75.20
71125914|NCT02294734|141757732|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||84.29|TWO_SIDED|95.0|0.97|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Length Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.97|84.29
71125915|NCT02294734|141757732|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||71.08|TWO_SIDED|95.0|0.98|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Length Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.98|71.08
71125916|NCT02294734|141757732|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||34.93|TWO_SIDED|95.0|0.98|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Diameter Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.98|34.93
71125917|NCT02294734|141757732|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||25.05|TWO_SIDED|95.0|0.98|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Diameter Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.98|25.05
71125918|NCT02294734|141757733|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||28.51|TWO_SIDED|95.0|0.97|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Length/Diameter Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.97|28.51
71125919|NCT02294734|141757733|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||32.15|TWO_SIDED|95.0|0.97|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Length/Diameter Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.97|32.15
71125920|NCT02294734|141757733|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||66.51|TWO_SIDED|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Length/Diameter Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.97|66.51
71125921|NCT02294734|141757733|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||45.28|TWO_SIDED|95.0|0.98|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Length/Diameter Day 28 The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.98|45.28
71125922|NCT02294734|141757741|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-2.0||||0.487|TWO_SIDED|95.0|-118.5|115.3|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 28|||115.3|-118.5|0.487
71125923|NCT02294734|141757741|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|60.6||||0.816|TWO_SIDED|95.0|-73.3|194.3|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 84|||194.3|-73.3|0.816
71125924|NCT02294734|141757744|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.144||||0.151|TWO_SIDED|95.0|-0.42|0.133|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 28|||0.133|-0.420|0.151
70857561|NCT02239120|141201167|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.4352|TWO_SIDED|95.0|0.49|1.36|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.36|0.49|0.4352
71088506|NCT00644059|141683310|SUPERIORITY_OR_OTHER||GMT[A/Solomon Islands/2006 (A/H1N1)]|1.21|||||TWO_SIDED|95.0|0.83|1.78|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.78|0.83|
71088507|NCT00644059|141683310|SUPERIORITY_OR_OTHER||GMT [A/Solomon Islands/2006 (A/H1N1]|7.54|||||TWO_SIDED|95.0|5.33|11.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||11|5.33|
71088508|NCT00644059|141683310|SUPERIORITY_OR_OTHER||GMT[A/Solomon Islands/2006 (A/H1N1)]|3.31|||||TWO_SIDED|95.0|2.4|4.55|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||4.55|2.4|
71088509|NCT00644059|141683310|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|0.9|||||TWO_SIDED|95.0|0.74|1.1|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.1|0.74|
71088510|NCT00644059|141683310|SUPERIORITY_OR_OTHER||GMT[A/Wisconsin/2009 (A/H3N2)]|3.54|||||TWO_SIDED|95.0|2.78|4.51|||GMT|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||4.51|2.78|
71088511|NCT00644059|141683310|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|13.0|||||TWO_SIDED|95.0|10.0|16.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||16|10|
71088512|NCT00644059|141683310|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|3.6|||||TWO_SIDED|95.0|2.61|4.95|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||4.95|2.61|
71125925|NCT02294734|141757744|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.121||||0.712|TWO_SIDED|95.0|-0.305|0.551|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 84|||0.551|-0.305|0.712
71125926|NCT02294734|141757745|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.18||||0.817|TWO_SIDED|95.0|-0.216|0.57|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 28|||0.570|-0.216|0.817
71125927|NCT02294734|141757745|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.114||||0.697|TWO_SIDED|95.0|-0.324|0.549|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 84|||0.549|-0.324|0.697
71088513|NCT00644059|141683310|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.0|||||TWO_SIDED|95.0|1.0|1.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1|1|
71088514|NCT00644059|141683310|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.06|||||TWO_SIDED|95.0|1.02|1.11|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.11|1.02|
71088515|NCT00644059|141683310|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.74|||||TWO_SIDED|95.0|1.57|1.92|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.92|1.57|
71088516|NCT00644059|141683310|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.0|||||TWO_SIDED|95.0|0.92|1.08|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.08|0.92|
71088517|NCT00644059|141683313|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H1N1)]|0.96|||||TWO_SIDED|95.0|0.78|1.19|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.19|0.78|
71088518|NCT00644059|141683313|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H1N1)]|6.41|||||TWO_SIDED|95.0|4.69|8.76|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||8.76|4.69|
71088519|NCT00644059|141683313|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H1N1)]|8.26|||||TWO_SIDED|95.0|6.36|11.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||11|6.36|
71088520|NCT00644059|141683313|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H1N1)]|4.37|||||TWO_SIDED|95.0|3.38|5.65|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||5.65|3.38|
71088521|NCT00644059|141683313|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H3N2)]|1.05|||||TWO_SIDED|95.0|0.82|1.35|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Brisbane/2007 (A/H3N2) in terms of Geometric Mean Titers GMTs in subjects aged 6 to \<72 months by HI assay.||1.35|0.82|
71088522|NCT00644059|141683313|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H3N2)]|6.42|||||TWO_SIDED|95.0|4.72|8.73|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||8.73|4.72|
71088523|NCT00644059|141683313|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H3N2)]|7.98|||||TWO_SIDED|95.0|6.2|10.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||10|6.2|
71088524|NCT00644059|141683313|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H3N2)]|3.13|||||TWO_SIDED|95.0|2.42|4.05|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||4.05|2.42|
71088525|NCT00644059|141683313|SUPERIORITY_OR_OTHER||GMT [B/Florida/2006]|0.97|||||TWO_SIDED|95.0|0.9|1.05|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.05|0.9|
71088526|NCT00644059|141683313|SUPERIORITY_OR_OTHER||GMT [B/Florida/2006]|1.56|||||TWO_SIDED|95.0|1.26|1.93|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.93|1.26|
71088527|NCT00644059|141683313|SUPERIORITY_OR_OTHER||GMT [B/Florida/2006]|5.0|||||TWO_SIDED|95.0|4.25|5.88|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||5.88|4.25|
71088528|NCT00644059|141683313|SUPERIORITY_OR_OTHER||GMT [B/Florida/2006]|2.55|||||TWO_SIDED|95.0|2.22|2.93|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||2.93|2.22|
71088529|NCT00644059|141683313|SUPERIORITY_OR_OTHER||GMT [A/Solomon Islands/2006 (A/H1N1)]|0.96|||||TWO_SIDED|95.0|0.75|1.22|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day1 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.22|0.75|
71088530|NCT00644059|141683313|SUPERIORITY_OR_OTHER||GMT [A/Solomon Islands/2006 (A/H1N1)]|1.72|||||TWO_SIDED|95.0|1.17|2.51|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||2.51|1.17|
71088531|NCT00644059|141683313|SUPERIORITY_OR_OTHER||GMT [A/Solomon Islands/2006 (A/H1N1)]|5.58|||||TWO_SIDED|95.0|4.08|7.63|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||7.63|4.08|
71088532|NCT00644059|141683313|SUPERIORITY_OR_OTHER||GMT [A/Solomon Islands/2006 (A/H1N1)]|3.11|||||TWO_SIDED|95.0|2.3|4.2|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||4.2|2.3|
71125928|NCT02294734|141757748|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.171||||0.965|TWO_SIDED|95.0|0.988|1.388|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.||||1.388|0.988|0.965
71088533|NCT00644059|141683313|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|0.98|||||TWO_SIDED|95.0|0.74|1.3|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.3|0.74|
71088534|NCT00644059|141683313|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|3.14|||||TWO_SIDED|95.0|2.19|4.49|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||4.49|2.19|
71088535|NCT00644059|141683313|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|7.36|||||TWO_SIDED|95.0|5.51|9.82|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||9.82|5.51|
71088536|NCT00644059|141683313|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|2.66|||||TWO_SIDED|95.0|2.0|3.55|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||3.55|2|
71088537|NCT00644059|141683313|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.0|||||TWO_SIDED|95.0|0.98|1.01|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.01|0.98|
71088538|NCT00644059|141683313|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.13|||||TWO_SIDED|95.0|1.05|1.22|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.22|1.05|
71088539|NCT00644059|141683313|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.79|||||TWO_SIDED|95.0|1.63|1.97|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.97|1.63|
71088540|NCT00644059|141683313|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.08|||||TWO_SIDED|95.0|1.0|1.17|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.17|1|
71088541|NCT02497469|141683331|SUPERIORITY||Adjusted Difference|8.8||||0.0061|TWO_SIDED|95.0|2.5|15.0|||Cochran-Mantel-Haenszel||||P-value of the adjusted difference was based on the Cochran-Mantel-Haenszel method, stratified by concomitant use of oral corticosteroids (Yes/No) and prior use of TNF-alpha antagonist (Yes/No) or the Fisher's exact method if the numerator was \<=5.|15.0|2.5|0.0061
71088542|NCT02497469|141683332|SUPERIORITY||Adjusted Difference|11.9||||0.0005|TWO_SIDED|95.0|5.3|18.5|||Cochran-Mantel-Haenszel||||P-value of the adjusted difference was based on the Cochran-Mantel-Haenszel method, stratified by concomitant use of oral corticosteroids (Yes/No) and prior use of TNF-alpha antagonist (Yes/No) or the Fisher's exact method if the numerator was \<=5.|18.5|5.3|0.0005
71088543|NCT02497469|141683333|SUPERIORITY||Adjusted Difference|-9.3||||0.0641|TWO_SIDED|95.0|-18.9|0.4|||Cochran-Mantel-Haenszel||||P-value of the adjusted difference was based on the Cochran-Mantel-Haenszel method, stratified by prior use of TNF-alpha antagonist (Yes/No) or the Fisher's exact method if the numerator was \<=5.|0.4|-18.9|0.0641
71088544|NCT03217591|141683419|SUPERIORITY||Geometric mean change (%)|-16.0|||=|0.2142|TWO_SIDED|90.0|-33.3|5.8|||Mixed Models Analysis|||Treatment comparison between placebo and praliciguat 20 mg. Geometric mean change (%) and the associated confidence intervals (CIs) were derived as 100×\[exp(Least Squares Mean Change)-1\].||5.8|-33.3|=0.2142
70946247|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.477|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 24 h PS;||||0.4770
70946248|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3625|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 24 h PS;||||0.3625
71088545|NCT03217591|141683419|SUPERIORITY||Geometric mean change (%)|-14.6|||=|0.2718|TWO_SIDED|90.0|-32.7|8.3|||Mixed Models Analysis|||Treatment comparison between placebo and praliciguat 40 mg. Geometric mean change (%) and the associated CIs were derived as 100×\[exp(Least Squares Mean Change)-1\].||8.3|-32.7|=0.2718
70946249|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0617|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 24 h PS;||||0.0617
70946250|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3061|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 72 h PS;||||0.3061
71088546|NCT03217591|141683419|SUPERIORITY||Geometric mean change (%)|-15.3|||=|0.1736|TWO_SIDED|90.0|-30.7|3.6|||Mixed Models Analysis|||Treatment comparison between placebo and praliciguat overall. Geometric mean change (%) and the associated CIs were derived as 100×\[exp(Least Squares Mean Change)-1\].||3.6|-30.7|=0.1736
71088547|NCT01251042|141683433|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Information about the size of the standard deviation (SD) for the change was obtained from an earlier study. The SD for the change from pre-operation until 24 hours after start of transfusion was 0.2305. Due to the imprecise measuring device (if values below 0.3 g/l) and the large SD, a non-inferiority margin (∆) of 0.2 g/l was decided to be used in this study, resulting in a total number of 42 evaluable subjects, i.e. 21 subjects per group.||||||0.6294||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6294
71088548|NCT00269152|141683442|SUPERIORITY_OR_OTHER||Feasibility Response Rate (percentage)|59.4|||||TWO_SIDED|95.0|46.4|71.5||||||||71.5|46.4|
71088549|NCT00269152|141683442|SUPERIORITY_OR_OTHER||Feasibility Response Rate (percentage)|50.0||||||95.0|36.1|63.9||||||||63.9|36.1|
71125929|NCT02294734|141757748|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.114||||0.913|TWO_SIDED|95.0|0.953|1.305|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.||||1.305|0.953|0.913
71088550|NCT04249427|141683447|EQUIVALENCE|Test if the change in mean number of days with significant mid-facial pain in Erenuman group differs from that in Placebo group.||||||0.96|||||||ANOVA|||||||0.96
71125930|NCT02250664|141757795|SUPERIORITY||Mean Difference (Net)|-5.33|STANDARD_ERROR_OF_MEAN|1.06|<|0.0001|TWO_SIDED|95.0|-7.41|-3.26||The p-value is Bonferroni-corrected for multiple comparisons with a priori threshold of significance P \< 0.0167|ANCOVA||Group difference = 0.12 mg nicotine - 0.8 mg nicotine|The statistical analysis method was ANCOVA, in order to test for statistically significant differences between group means, while controlling for covariates of interest. It was calculated that 207 subjects per group would be required to have at least 90% power to detect a mean difference of 4.52 CPD between the 0.8 mg and 0.12 mg groups at week 12, with significance level alpha of 0.0167. The significance level reflects the Bonferroni correction needed for testing of all pairwise comparisons.||-3.26|-7.41|<0.0001
71125931|NCT02250664|141757795|SUPERIORITY||Mean Difference (Net)|-7.54|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|-9.51|-5.57||The p-value is Bonferroni-corrected for multiple comparisons with a priori threshold of significance P \< 0.0167|ANOVA|||The statistical analysis method was ANCOVA, in order to test for statistically significant differences between group means, while controlling for covariates of interest. It was calculated that 207 subjects per group would be required to have at least 90% power to detect a mean difference of 4.52 CPD between the 0.8 mg and 0.12 mg groups at week 12, with significance level alpha of 0.0167. The significance level reflects the Bonferroni correction needed for testing of all pairwise comparisons.|Group difference = 0.03 mg nicotine - 0.8 mg nicotine|-5.57|-9.51|<0.0001
71125932|NCT03847909|141757796|SUPERIORITY|P value is from an ANCOVA model with treatment group as the main effect, age category, baseline eGFR category, baseline Uox value as covariates for adjustment.|Difference of Least Mean Square|5171.7|STANDARD_ERROR_OF_MEAN|1144.07|<|0.0001|TWO_SIDED|95.0|2929.3|7414.2|||ANCOVA|||||7414.2|2929.3|<0.0001
70946251|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2207|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at EOT;||||0.2207
70946252|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at EOT;||||0.3173
71088551|NCT04249427|141683448|EQUIVALENCE|Test if the change in SNOT-22 score in Erenuman group differs from that in Placebo group.||||||0.19|||||||ANOVA|||||||0.19
71088552|NCT04249427|141683449|EQUIVALENCE|Test if the change in Physical Function as Measured by Migraine Function Impact in Erenuman group differs from that in Placebo group.||||||0.06|||||||ANOVA|||||||0.06
71088553|NCT04249427|141683450|EQUIVALENCE|Test if the change in Usual Activities as Measured by Migraine Function Impact in Erenuman group differs from that in Placebo group.||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
71088554|NCT04249427|141683451|EQUIVALENCE|Test if the change in Social Function as Measured by Migraine Function Impact in Erenuman group differs from that in Placebo group.||||||0.058|||||||ANOVA|||||||0.058
71088555|NCT04249427|141683452|EQUIVALENCE|Test if the change in Emotional Function as Measured by Migraine Function Impact in Erenuman group differs from that in Placebo group.||||||0.02|||||||ANOVA|||||||0.02
71088556|NCT04249427|141683453|EQUIVALENCE|Test if the change in Overall Impact (global) as Measured by Migraine Function Impact in Erenuman group differs from that in Placebo group.||||||0.0036|||||||ANOVA|||||||0.0036
71088557|NCT04249427|141683454|EQUIVALENCE|Test if the change of average number of days per month with significant nasal congestion in Erenuman group differs from that in Placebo group.||||||0.83|||||||ANOVA|||||||0.83
71088558|NCT04249427|141683455|EQUIVALENCE|Test if the change of average number of days per month with significant significant rhinorrhea in Erenuman group differs from that in Placebo group||||||0.83|||||||ANOVA|||||||0.83
70857562|NCT02239120|141201168|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.0003|TWO_SIDED|95.0|1.12|1.47|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.47|1.12|0.0003
70946253|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9191|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 3 h PS;||||0.9191
70946254|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 3 h PS;||||0.3173
71125933|NCT00117793|141757833|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Statistical significance was set a-priori at p \< 0.05.|Mixed Models Analysis|The effect of study limb on limb volume was analyzed using repeated measures one-way analyses of variance.||||||>0.05
71125934|NCT00117793|141757834|SUPERIORITY_OR_OTHER||||||=|0.0056||95.0||||Statistical significance was set a-priori at p \< 0.05.|Mixed Models Analysis|The effect of study limb on activity level was analyzed using repeated measures one-way analyses of variance.||||||=0.0056
71125935|NCT00117793|141757835|SUPERIORITY_OR_OTHER||||||=|0.0021||95.0||||Statistical significance was set a-priori at p \< 0.05.|Mixed Models Analysis|The effect of study limb on limb pistoning was analyzed using repeated measures one-way analyses of variance.||||||=0.0021
71125936|NCT04268173|141757839|EQUIVALENCE|A two sample t-test was conducted to test the null hypothesis that the pre-intervention mean response was equivalent to the post-intervention mean response in the Prevention Navigation group. Hypothesis: A p-value greater than 0.05 suggests the means are not statistically different from one another.||||||0.84|||||||t-test, 2 sided|||||||0.84
71125937|NCT00975143|141757851|NON_INFERIORITY_OR_EQUIVALENCE|Pre-defined criterion for non-inferiority: upper bound of the 95% CI for the treatment difference \< 4.|LS Mean Difference|0.1382||||0.5077|TWO_SIDED|95.0|-0.2712|0.5475||P values are from analysis of covariance (ANCOVA) controlling for Baseline total nodular lesion count, gender and analysis site.|ANCOVA|The 95% CI of the adjusted least square mean difference (CIP-ISOTRETINOIN minus Isotretinoin) was calculated using the ANCOVA model.||Change from Baseline was calculated as the post-Baseline value minus the Baseline value||0.5475|-0.2712|0.5077
71125938|NCT00975143|141757852|NON_INFERIORITY_OR_EQUIVALENCE|If the two co-primary endpoints were significant, a 95% 2 sided CI on the difference between treatments (CIP-Isotretinoin minus Isotretinoin) was calculated.|Proportion difference|-3.48|||>|0.05|TWO_SIDED|95.0|-8.4|1.4|||Normal approximation|95% CI on difference in proportions (CIP-Isotretinoin minus Isotretinoin) was estimated using normal approximation.||The analysis of the secondary efficacy endpoint was based on observed cases only, with no imputation for missing values.||1.4|-8.4|>0.05
71125939|NCT00975143|141757853|NON_INFERIORITY_OR_EQUIVALENCE|Pre-defined criterion for non-inferiority: lower bound of the 95% CI for the treatment difference \> -10.|Proportion difference|-2.1|||>|0.05|TWO_SIDED|95.0|-7.94|3.74|||Normal approximation|||||3.74|-7.94|>0.05
71125940|NCT00545103|141757855|SUPERIORITY_OR_OTHER_LEGACY|||||||0.778||95.0|||||Cochran-Mantel-Haenszel|||||||0.778
71125941|NCT00545103|141757855|SUPERIORITY_OR_OTHER_LEGACY|||||||0.159||95.0|||||Cochran-Mantel-Haenszel|||||||0.159
71125942|NCT00545103|141757855|SUPERIORITY_OR_OTHER_LEGACY|||||||0.368||95.0|||||Cochran-Mantel-Haenszel|||||||0.368
71125943|NCT00545103|141757856|SUPERIORITY_OR_OTHER_LEGACY|||||||0.685||95.0|||||Cochran-Mantel-Haenszel|||||||0.685
71125944|NCT00545103|141757856|SUPERIORITY_OR_OTHER_LEGACY|||||||0.198||95.0|||||Cochran-Mantel-Haenszel|||||||0.198
71125945|NCT00545103|141757856|SUPERIORITY_OR_OTHER_LEGACY|||||||0.441||95.0|||||Cochran-Mantel-Haenszel|||||||0.441
71125946|NCT00082381|141757865|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified non-inferiority margin was 0.4% (i.e., noninferiority is demonstrated if the upper limit of a two-sided 95% confidence interval for the difference in change in HbA1c between exenatide and insulin glargine is less than 0.4%.)|Mean Difference (Final Values)|0.05||||0.4602||95.0|-0.09|0.2|||ANCOVA|||||0.20|-0.09|0.4602
71125947|NCT00082381|141757866|SUPERIORITY_OR_OTHER|||||||0.7839||95.0|||||Fisher Exact|||||||0.7839
71125948|NCT00082381|141757867|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
70946255|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2207|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 3 h PS;||||0.2207
71125949|NCT00082381|141757868|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71125950|NCT00082381|141757870|SUPERIORITY_OR_OTHER|||||||0.3002||95.0|||||Fisher Exact|||||||0.3002
71125951|NCT00082381|141757871|SUPERIORITY_OR_OTHER|||||||0.3385||95.0|||||ANCOVA|||||||0.3385
71125952|NCT00884832|141757907|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Proportion of semi-formed and loose stools (Bristol Form 5-7) associated with diarrhea subgroup versus no diarrhea subgroup.||||<0.001
71125953|NCT00884832|141757908|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||ANCOVA|||||||0.018
71125954|NCT00884832|141757908|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||ANCOVA|||drug\*group interactions||||0.047
71125955|NCT00884832|141757910|SUPERIORITY_OR_OTHER|||||||0.082||95.0|||||ANCOVA|||||||0.082
71125956|NCT02096263|141757911|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigens will be demonstrated if, for each of the three antigens, the upper limit of the 95% confidence interval (CI) on the GMC ratio \[Pediarix Group divided by Infanrix hexa Group\] is ≤ 1.5.|Adjusted GMC ratio|1.1|||||TWO_SIDED|95.0|0.92|1.31|||||Adjusted GMC (ANCOVA model adjusted with the vaccine group as fixed effect and the Infanrix vaccination history of the mother during pregnancy as continuous regressor).|To demonstrate the non-inferiority of Infanrix hexa to Pediarix co-administered with ActHIB, in terms of antibody geometric mean concentrations (GMCs) for pertussis antigen, pertussis toxoid (PT), one month after the third dose of the primary vaccination.||1.31|0.92|
70946256|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6692|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 24 h PS;||||0.6692
71088559|NCT04249427|141683456|EQUIVALENCE|Test if the change in doses of rescue pain medications in Erenuman group differs from that in Placebo group.||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.35
71088560|NCT04249427|141683457|EQUIVALENCE|Test if the change from baseline in mean daily pain score in Erenuman group differs from that in Placebo group.||||||0.85|||||||Wilcoxon (Mann-Whitney)|||||||0.85
71088561|NCT03886272|141683458|OTHER||Adjusted Geometric Mean Ratio (T1/R1)[%]|112.96||||0.0413|TWO_SIDED|90.0|102.7|124.26||P-value for ratio outside 80% -125%.|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as: T1/R1. Intra-individual geometric coefficient of variation (gCV) = 14.2|Relative bioavailability||124.26|102.70|0.0413
70857563|NCT03102190|141201173|OTHER||||||||||||||||||The analysis of the safety endpoints will be presented with means and standard deviations of their occurrence within the study population. The safety of the drug will be determined by analyzing the rate of adverse events in both phases of the trial. An occurrence of 10% within the study population will be considered significant.|||
70857564|NCT00402233|141201179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4|||<|0.0001||95.0|-6.53|-2.26|||ANCOVA|||||-2.26|-6.53|<0.0001
71088562|NCT03886272|141683458|OTHER||Adjusted Geometric Mean Ratio (T2/R2)[%]|115.49||||0.0776|TWO_SIDED|90.0|105.23|126.74||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as T2/R2. Intra-individual geometric coefficient of variation (gCV) = 13.9.|Relative bioavailability||126.74|105.23|0.0776
70946257|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7793|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 24 h PS;||||0.7793
70857565|NCT00402233|141201179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.41|||<|0.0001||95.0|-6.54|-2.28|||ANCOVA|||||-2.28|-6.54|<0.0001
70857566|NCT00402233|141201179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.72|||<|0.0001||95.0|-6.91|-2.52|||ANCOVA|||||-2.52|-6.91|<0.0001
71088563|NCT03886272|141683458|OTHER||Adj. Geometric Mean Ratio (T3c/R3) [%]|78.05||||0.6443|TWO_SIDED|90.0|69.71|87.38||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as Tc3/R3. Intra-individual geometric coefficient of variation (gCV) = 17.6.|Relative bioavailability||87.38|69.71|0.6443
71088564|NCT03886272|141683458|OTHER||Adj. Geometric Mean Ratio (T3u/R3) [%]|45.97||||1|TWO_SIDED|90.0|41.05|51.48||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as T3u/R3. Intra-individual geometric coefficient of variation (gCV) = 17.6.|Relative bioavailability||51.48|41.05|1.00
71088565|NCT03886272|141683459|OTHER||Adjusted Geometric Mean Ratio (T1/R1)[%]|144.62||||0.9485|TWO_SIDED|90.0|124.82|167.57||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as T1/R1. Intra-individual geometric coefficient of variation (gCV) = 22.1|Relative bioavailability||167.57|124.82|0.9485
71088566|NCT03886272|141683459|OTHER||Adjusted Geometric Mean Ratio (T2/R2)[%]|129.69||||0.7813|TWO_SIDED|90.0|119.51|140.73||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The adjusted geometric mean is geometric mean adjusted by treatment. Ratio is calculated as T2/R2. Intra-individual geometric coefficient of variation (gCV) = 12.2.|Relative Bioavailability||140.73|119.51|0.7813
71088567|NCT03886272|141683459|OTHER||Adj. Geometric Mean Ratio (T3c/R3) [%]|75.09||||0.7616|TWO_SIDED|90.0|64.58|87.32||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as = T3c/3. Intra-individual geometric coefficient of variation (gCV) = 23.5.|Relative Bioavailability||87.32|64.58|0.7616
71125957|NCT02096263|141757911|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigens will be demonstrated if, for each of the three antigens, the upper limit of the 95% confidence interval (CI) on the GMC ratio \[Pediarix Group divided by Infanrix hexa Group\] is ≤ 1.5.|Adjusted GMC ratio|1.14|||||TWO_SIDED|95.0|0.97|1.35|||||Adjusted GMC (ANCOVA model adjusted with the vaccine group as fixed effect and the Infanrix vaccination history of the mother during pregnancy as continuous regressor).|To demonstrate the non-inferiority of Infanrix hexa to Pediarix co-administered with ActHIB, in terms of antibody geometric mean concentrations (GMCs) for pertussis antigen, filamentous hemagglutinin (FHA), one month after the third dose of the primary vaccination.||1.35|0.97|
71125958|NCT02096263|141757911|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigens will be demonstrated if, for each of the three antigens, the upper limit of the 95% confidence interval (CI) on the GMC ratio \[Pediarix Group divided by Infanrix hexa Group\] is ≤ 1.5.|Adjusted GMC ratio|0.79|||||TWO_SIDED|95.0|0.63|0.99|||||Adjusted GMC (ANCOVA model adjusted with the vaccine group as fixed effect and the Tdap vaccination history of the mother during pregnancy as continuous regressor.).|To demonstrate the non-inferiority of Infanrix hexa to Pediarix co-administered with ActHIB, in terms of antibody geometric mean concentrations (GMCs) for pertussis antigen, pertactin (PRN), one month after the third dose of the primary vaccination.||0.99|0.63|
71125959|NCT02337725|141757954|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.39|||<|0.0001|TWO_SIDED|95.0|-8.53|-4.25|||ANCOVA||Estimated Value was reported for the least squares mean difference between TVP-1012 1mg and Placebo (TVP-1012 1mg - Placebo).|||-4.250|-8.530|<0.0001
70857567|NCT00402233|141201180|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.893||||||95.0|0.431|1.849|||Regression, Logistic|||||1.849|0.431|
71088568|NCT03886272|141683459|OTHER||Adj. Geometric Mean Ratio (T3u/R3) [%]|41.45||||1|TWO_SIDED|90.0|35.61|48.25||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as = T3u/R3. Intra-individual geometric coefficient of variation = 23.5.|Relative Bioavailability||48.25|35.61|1.00
71088569|NCT03886272|141683460|OTHER||Adjusted Geometric Mean Ratio (T1/R1)[%]|111.11|STANDARD_DEVIATION|11.5||0.0092|TWO_SIDED|90.0|102.87|120.01||P-value for ratio outside 80% - 125%.|ANOVA|The model included fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as T1/R1. Intra-individual geometric coefficient of variation (gCV) = 17.6.|Relative Bioavailability||120.01|102.87|0.0092
71088570|NCT03886272|141683460|OTHER||Adjusted Geometric Mean Ratio (T2/R2)[%]|114.13||||0.0442|TWO_SIDED|90.0|104.58|124.56||P-value for ratio outside 80% - 125%.|ANOVA|The model included fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as = T2/R2. Intra-individual geometric coefficient of variation (gCV) = 13.0.|Relative Bioavailability||124.56|104.58|0.0442
71088571|NCT03886272|141683460|OTHER||Adj. Geometric Mean Ratio (T3c/R3) [%]|80.1||||0.4928|TWO_SIDED|90.0|71.54|89.68||P-value for ratio outside 80% - 125%|ANOVA|The model included fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as = T3c/R3. Intra-individual geometric coefficient of variation (gCV) = 17.6.|Relative Bioavailability||89.68|71.54|0.4928
71088572|NCT03886272|141683460|OTHER||Adj. Geometric Mean Ratio (T3u/R3) [%]|48.83||||1|TWO_SIDED|90.0|43.6|54.69||P-value for ratio outside 80% - 125%.|ANOVA|The model included fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as T3u/R3. Intra-individual geometric coefficient of variation (gCV) = 17.6.|Relative Bioavailability||54.69|43.60|1.00
71088573|NCT00931632|141683461|SUPERIORITY_OR_OTHER|||||||0.427|TWO_SIDED||||||Mantel Haenszel|||||||0.427
71125960|NCT03322423|141757963|SUPERIORITY|Statistical superiority was concluded if the upper limit of the confidence intervals of the Test lens was below +0.01 logMAR for distance.|Least-Square Mean Estimate|-0.058|STANDARD_ERROR_OF_MEAN|0.0114|||TWO_SIDED|95.0|-0.08|-0.035|||Linear mixed model analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||-0.035|-0.080|
71125961|NCT03322423|141757963|SUPERIORITY|Statistical superiority was concluded if the upper limit of the confidence intervals of the Test lens was below +0.01 logMAR for distance.|Least-Square Mean Estimate|-0.076|STANDARD_ERROR_OF_MEAN|0.0114|||TWO_SIDED|95.0|-0.099|-0.054|||Linear mixed model analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||-0.054|-0.099|
71125962|NCT03322423|141757964|SUPERIORITY|Statistical superiority was concluded if the upper limit of the confidence intervals of the Test lens was below +0.17 logMAR for near.|LS Mean Estimate|0.141|STANDARD_ERROR_OF_MEAN|0.0147|||TWO_SIDED|95.0|0.112|0.17|||Linear mixed model analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||0.170|0.112|
71125963|NCT03322423|141757964|SUPERIORITY|Statistical superiority was concluded if the upper limit of the confidence intervals of the Test lens was below +0.17 logMAR for near.|LS Mean Estimate|0.141|STANDARD_ERROR_OF_MEAN|0.0147|||TWO_SIDED|95.0|0.112|0.17|||Linear mixed model analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||0.170|0.112|
71125964|NCT03322423|141757965|SUPERIORITY|Statistical superiority was concluded if the lower limit of the confidence intervals of the Test lens was above 32 CLUE points.|LS Mean Estimate|45.5|STANDARD_ERROR_OF_MEAN|2.19|||TWO_SIDED|95.0|41.2|49.9|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||49.9|41.2|
71125965|NCT03322423|141757965|SUPERIORITY|Statistical superiority was concluded if the lower limit of the confidence intervals of the Test lens was above 32 CLUE points.|LS Mean Estimate|46.4|STANDARD_ERROR_OF_MEAN|2.21|||TWO_SIDED|95.0|42.1|50.8|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||50.8|42.1|
71088574|NCT03188055|141683476|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||0.006
71088575|NCT03188055|141683477|SUPERIORITY|||||||0.709|||||||t-test, 2 sided|||||||0.709
71088576|NCT03188055|141683478|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
71088577|NCT03188055|141683479|SUPERIORITY|||||||0.063|||||||t-test, 2 sided|||||||0.063
71088578|NCT03188055|141683480|SUPERIORITY|||||||0.892|||||||t-test, 2 sided|||||||0.892
71088579|NCT03188055|141683481|SUPERIORITY||||||>|0.99||||||Using an a priori statistical significance of 0.05.|Fisher Exact|||Comparison of concordance status by intervention status (outcome by predictor).||||> . 99
71088580|NCT03188055|141683482|SUPERIORITY|||||||0.188|||||||t-test, 2 sided|||||||0.188
71088581|NCT03188055|141683483|SUPERIORITY|||||||0.042|||||||t-test, 2 sided|||||||0.042
71088582|NCT03188055|141683485|SUPERIORITY|||||||0.698|||||||t-test, 2 sided|||||||0.698
71088583|NCT03188055|141683486|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
71088584|NCT01257347|141683508|SUPERIORITY_OR_OTHER||||||<=|0.001||||||We included a stopping rule in which recruitment would be stopped at the midpoint for futility if the z-score was negative or for efficacy if the z-score was positive and the p-value ≤ 0.001.|GEE model|GEE models (logit link) with clinician as the cluster variable, appropriateness of management as outcome, intervention group as explanatory variable.||The sample size was calculated to have sufficient power to detect meaningful differences in appropriateness of clinician management between intervention and control groups. Each patient-clinician encounter was treated as independent and the sample size was inflated to account for the design effect (DE) of clustering of patients within clinician. GEE stands for generalized estimating equation.||||<=0.001
71088585|NCT03204643|141683512|SUPERIORITY||Odds Ratio (OR)|0.74||||0.06|TWO_SIDED|95.0|0.54|1.02|||Regression, Logistic|||||1.02|0.54|0.06
70857568|NCT00402233|141201180|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.885||||||95.0|0.424|1.845|||Regression, Logistic|||||1.845|0.424|
70857569|NCT00402233|141201180|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.687||||||95.0|0.317|1.492|||Regression, Logistic|||||1.492|0.317|
70946258|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6065|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 24 h PS;||||0.6065
71088586|NCT03204643|141683513|SUPERIORITY||Odds Ratio (OR)|1.07||||0.76|TWO_SIDED|95.0|0.7|1.64|||Mixed Models Analysis|||||1.64|0.70|0.76
71125966|NCT02453555|141757966|SUPERIORITY_OR_OTHER||Adjusted Mean Difference (Net)|-1.14|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.36|-0.91|||Mixed Models Analysis||Adjusted Mean Difference was calculated as: (adjusted mean change from baseline in HbA1c at Week 24 in Empagliflozin 10 mg/linagliptin 5 mg group) - (adjusted mean change from baseline in HbA1c at Week 24 in Linagliptin 5 mg + Placebo 10 mg group)|A restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach was used with baseline HbA1c as linear covariate and baseline estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease \[MDRD\] formula), prior use of antidiabetic drug, treatment, visit, visit by Treatment interaction as fixed effect(s). The covariance used to fit the model was unstructured.||-0.91|-1.36|<0.0001
71125967|NCT02453555|141757968|SUPERIORITY_OR_OTHER||Adjusted Mean Difference (Net)|-1.22|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.45|-0.99|||Mixed Models Analysis||Adjusted Mean Difference was calculated as: (adjusted mean change from baseline in HbA1c at Week 52 in All Empagliflozin group) - (adjusted mean change from baseline in HbA1c at Week 52 in All Placebo group)|A restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach was used with baseline HbA1c as linear covariate and baseline estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease \[MDRD\] formula), prior use of antidiabetic drug, treatment, visit, visit by Treatment interaction as fixed effect(s). The covariance used to fit the model was unstructured.||-0.99|-1.45|<0.0001
71125968|NCT02453555|141757969|SUPERIORITY_OR_OTHER||Adjusted Mean Difference (Net)|-1.21|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.45|-0.96|||Mixed Models Analysis||Adjusted Mean Difference was calculated as: (adjusted mean change from baseline in HbA1c at Week 52 in Empagliflozin 25 mg/linagliptin 5 mg group) - (adjusted mean change from baseline in HbA1c at Week 52 in Linagliptin 5 mg + Placebo 25 mg group)|A restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach was used with baseline HbA1c as linear covariate and baseline estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease \[MDRD\] formula), prior use of antidiabetic drug, treatment, visit, visit by Treatment interaction as fixed effect(s). The covariance used to fit the model was unstructured.||-0.96|-1.45|<0.0001
71125969|NCT02453555|141757970|SUPERIORITY_OR_OTHER||Adjusted Mean Difference (Net)|-1.09|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.34|-0.84|||Mixed Models Analysis||Adjusted Mean Difference was calculated as: (adjusted mean change from baseline in HbA1c at Week 52 in Empagliflozin 25 mg/linagliptin 5 mg group) - (adjusted mean change from baseline in HbA1c at Week 52 in All Placebo group)|A restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach was used with baseline HbA1c as linear covariate and baseline estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease \[MDRD\] formula), prior use of antidiabetic drug, treatment, visit, visit by Treatment interaction as fixed effect(s). The covariance used to fit the model was unstructured.||-0.84|-1.34|<0.0001
71125970|NCT00500760|141757971|SUPERIORITY_OR_OTHER||Difference in Kaplan-Meier estimate|-0.07|||||TWO_SIDED|95.0|-0.23|0.09|||||The difference between the treatment groups is calculated as panitumumab plus chemoradiation minus chemoradiotherapy alone.|||0.09|-0.23|
71125971|NCT00500760|141757972|SUPERIORITY_OR_OTHER||Difference in Kaplan-Meier estimate|-0.03|||||TWO_SIDED|95.0|-0.18|0.12|||||The difference between the treatment groups is calculated as panitumumab plus chemoradiation minus chemoradiotherapy alone.|Difference between treatment groups at 6 months||0.12|-0.18|
71125972|NCT00500760|141757972|SUPERIORITY_OR_OTHER||Difference in Kaplan-Meier estimate|-0.03|||||TWO_SIDED|95.0|-1.09|0.12|||||The difference between the treatment groups is calculated as panitumumab plus chemoradiation minus chemoradiotherapy alone.|Difference between treatment groups at 12 months||0.12|-1.09|
71125973|NCT00500760|141757973|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.328||||0.3106|TWO_SIDED|95.0|0.767|2.299|||Regression, Cox||Hazard ratio is presented as panitumumab plus chemoradiation:chemoradiotherapy alone.|||2.299|0.767|0.3106
71125974|NCT00500760|141757974|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.6069|TWO_SIDED|95.0|0.675|1.961|||Regression, Cox||Hazard ratio is presented as panitumumab plus chemoradiation:chemoradiotherapy alone.|||1.961|0.675|0.6069
71125975|NCT00500760|141757975|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.628||||0.1223|TWO_SIDED|95.0|0.877|3.019|||Regression, Cox||Hazard ratio is presented as panitumumab plus chemoradiation:chemoradiotherapy alone.|||3.019|0.877|0.1223
71088587|NCT03204643|141683514|SUPERIORITY||Odds Ratio (OR)|1.16||||0.62|TWO_SIDED|95.0|0.65|2.08|||Mixed Models Analysis|||||2.08|0.65|0.62
71088588|NCT03204643|141683515|SUPERIORITY||Odds Ratio (OR)|1.35||||0.08|TWO_SIDED|0.96|0.96|1.9|||Mixed Models Analysis|||||1.90|0.96|0.08
71088589|NCT01618968|141683527|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability comparisons were performed at each dose level.|Test / Reference Ratio|127.99|||||TWO_SIDED|90.0|121.61|134.7||||||To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the abdomen using the VIBEX MTX device by measuring the area under the curve from time zero to the last measurable concentration AUC(0-inf).||134.70|121.61|
71125976|NCT00500760|141757976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.535||||0.1737|TWO_SIDED|95.0|0.217|1.262|||Regression, Logistic||The odds ratio is defined as the odds of having an overall response in the panitumumab plus chemoradiation arm relative to the odds in the chemoradiotherapy alone arm.|||1.262|0.217|0.1737
71125977|NCT00500760|141757976|SUPERIORITY_OR_OTHER||Difference in rate|-10.99|||||TWO_SIDED|95.0|-24.56|4.14|||||Difference is presented as the rate in panitumumab plus chemoradiation arm minus the rate in chemoradiotherapy alone arm.|||4.14|-24.56|
71125978|NCT00500760|141757977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.087||||1|TWO_SIDED|95.0|0.448|2.712|||Regression, Logistic||The odds ratio is defined as the odds of having a complete response in the panitumumab plus chemoradiation arm relative to the odds in the chemoradiotherapy alone arm.|||2.712|0.448|1.0000
71088590|NCT01618968|141683527|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability comparisons were performed at each dose level.|Test / Reference Ratio|125.48|||||TWO_SIDED|90.0|119.43|131.84||||||To compare the relative bioavailability of MTX following oral administration to that obtained after SC injection into the thigh using the VIBEX MTX device by measuring the AUC(0-Inf).||131.84|119.43|
71088591|NCT01618968|141683527|NON_INFERIORITY_OR_EQUIVALENCE|Test of bioequivalence was performed at each dose level.|Test / Reference ratio|101.85|||||TWO_SIDED|90.0|99.41|104.36||||||To compare the relative bioavailability of MTX following SC injection into the abdomen to that obtained after SC injection into the thigh using the VIBEX MTX device by measuring the AUC(0-inf)||104.36|99.41|
71125979|NCT00500760|141757977|SUPERIORITY_OR_OTHER||Difference in rate|1.33|||||TWO_SIDED|95.0|-13.23|14.71|||||Difference is presented as the rate in panitumumab plus chemoradiation arm minus the rate in chemoradiotherapy alone arm.|||14.71|-13.23|
71125980|NCT00129961|141757980|SUPERIORITY_OR_OTHER|||||||0.022||||||Poisson regression was used to model NMSC counts using the years in study as an offset. The generalized estimated equations (GEE) approach was used to estimate parameters and compare treatment differences.|Poisson regression|Adjusted by baseline strata; Poisson model = strata + treatment.||||||0.022
71125981|NCT00129961|141757981|SUPERIORITY_OR_OTHER|||||||0.047|||||||Regression, Cox|Stratified by baseline lesions||||||0.047
71125982|NCT00129961|141757982|SUPERIORITY_OR_OTHER|||||||0.015|||||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||||||0.015
71125983|NCT00129961|141757983|SUPERIORITY_OR_OTHER|||||||0.799||95.0|||||Chi-squared|||||||0.799
71125984|NCT00129961|141757984|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Well differentiated||||0.014
71125985|NCT00129961|141757984|SUPERIORITY_OR_OTHER|||||||0.491||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Moderately differentiated||||0.491
71125986|NCT00129961|141757984|SUPERIORITY_OR_OTHER|||||||0.905||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Poorly differentiated||||0.905
71125987|NCT00129961|141757984|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Invasive||||0.018
71125988|NCT00129961|141757984|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC In Situ||||0.012
71125989|NCT00129961|141757984|SUPERIORITY_OR_OTHER|||||||0.463||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Invasive with Perineural Invasion||||0.463
71125990|NCT00129961|141757984|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Invasive without Perineural Invasion||||0.004
71088592|NCT01618968|141683528|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability comparisons were performed at each dose level.|Test / Reference Ratio|127.65|||||TWO_SIDED|90.0|121.28|134.36||||||To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the abdomen using the VIBEX MTX device by measuring the area under the curve from time zero to the 24 hour concentration AUC(0-24)||134.36|121.28|
71125991|NCT00129961|141757984|SUPERIORITY_OR_OTHER|||||||0.094||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||BCC Superficial||||0.094
71125992|NCT00129961|141757984|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||BCC Nodular||||0.720
71125993|NCT00129961|141757984|SUPERIORITY_OR_OTHER|||||||0.227||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||BCC Infiltrative||||0.227
71125994|NCT00129961|141757985|SUPERIORITY_OR_OTHER|||||||0.748||95.0|||||Poisson regression|||||||0.748
71125995|NCT00129961|141757986|SUPERIORITY_OR_OTHER|||||||0.425||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||||||0.425
71125996|NCT00129961|141757989|SUPERIORITY_OR_OTHER|||||||0.604||95.0|||||ANCOVA|||||||0.604
71125997|NCT00129961|141757990|SUPERIORITY_OR_OTHER|||||||0.672||95.0|||||ANCOVA|||||||0.672
71125998|NCT00129961|141757991|SUPERIORITY_OR_OTHER|||||||0.999||95.0|||||Fisher Exact|||||||0.999
71125999|NCT00129961|141757992|SUPERIORITY_OR_OTHER|||||||0.588||95.0|||||Fisher Exact|||||||0.588
71126000|NCT00129961|141757993|SUPERIORITY_OR_OTHER|||||||0.999||95.0|||||Fisher Exact|||||||0.999
71126001|NCT00129961|141757994|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.030
71126002|NCT03178669|141757995|SUPERIORITY||Odds Ratio (OR)|2.0||||0.1806|TWO_SIDED|80.0|0.75|5.47||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||5.47|0.75|0.1806
71126003|NCT03178669|141757995|SUPERIORITY||Odds Ratio (OR)|0.7||||0.6649|TWO_SIDED|80.0|0.2|2.24||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.24|0.20|0.6649
71126004|NCT03178669|141757995|SUPERIORITY||Odds Ratio (OR)|3.8||||0.0247|TWO_SIDED|80.0|1.53|9.47||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||9.47|1.53|0.0247
71126005|NCT03178669|141757995|SUPERIORITY||Odds Ratio (OR)|1.4||||0.3279|TWO_SIDED|80.0|0.52|3.88||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||3.88|0.52|0.3279
71126006|NCT03178669|141757996|SUPERIORITY||Odds Ratio (OR)|1.9||||0.2115|TWO_SIDED|80.0|0.69|4.99||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||4.99|0.69|0.2115
71126007|NCT03178669|141757996|SUPERIORITY||Odds Ratio (OR)|0.3||||0.8498|TWO_SIDED|80.0|0.06|1.34||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.34|0.06|0.8498
71126008|NCT03178669|141757996|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0977|TWO_SIDED|80.0|1.01|6.62||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||6.62|1.01|0.0977
71126009|NCT03178669|141757996|SUPERIORITY||Odds Ratio (OR)|1.0||||0.522|TWO_SIDED|80.0|0.32|2.84||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.84|0.32|0.5220
71126010|NCT03178669|141757997|SUPERIORITY||Odds Ratio (OR)|1.5||||0.2335|TWO_SIDED|80.0|0.74|2.94||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.94|0.74|0.2335
70946259|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.357|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 72 h PS;||||0.3570
70946260|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.969|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 72 h PS;||||0.9690
70946261|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5299|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 72 h PS;||||0.5299
70946262|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4821|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at EOT;||||0.4821
70946263|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8295|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at EOT;||||0.8295
70946264|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3304|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at EOT;||||0.3304
70946265|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 3 h PS;||||0.2482
70946266|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 24 h PS;||||0.2482
71088593|NCT01618968|141683528|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability comparisons were performed at each dose level.|Test / Reference ratio|125.2|||||TWO_SIDED|90.0|119.16|131.55||||||To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the thigh using the VIBEX MTX device by measuring the area under the curve from time zero to the 24 hour concentration AUC(0-24)||131.55|119.16|
71088594|NCT01618968|141683528|NON_INFERIORITY_OR_EQUIVALENCE|Test of bioequivalence was performed at each dose level.|Test / Reference Ratio|101.82|||||TWO_SIDED|90.0|99.39|104.31||||||To compare the relative bioavailability of MTX following SC injection into the abdomen to that obtained after SC injection into the thigh using the VIBEX MTX device by measuring the area under the curve from time zero to the 24 hour concentration AUC(0-24)||104.31|99.39|
71126011|NCT03178669|141757997|SUPERIORITY||Odds Ratio (OR)|1.4||||0.2511|TWO_SIDED|80.0|0.73|2.69||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.69|0.73|0.2511
71126012|NCT03178669|141757997|SUPERIORITY||Odds Ratio (OR)|1.8||||0.1162|TWO_SIDED|80.0|0.96|3.52||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||3.52|0.96|0.1162
71126013|NCT03178669|141757997|SUPERIORITY||Odds Ratio (OR)|1.2||||0.3467|TWO_SIDED|80.0|0.63|2.4||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.40|0.63|0.3467
71126014|NCT03178669|141757998|SUPERIORITY||Odds Ratio (OR)|0.9||||0.6326|TWO_SIDED|80.0|0.5|1.5||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.50|0.50|0.6326
71126015|NCT03178669|141757998|SUPERIORITY||Odds Ratio (OR)|0.8||||0.7127|TWO_SIDED|80.0|0.45|1.37||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.37|0.45|0.7127
71126016|NCT03178669|141757998|SUPERIORITY||Odds Ratio (OR)|1.3||||0.2658|TWO_SIDED|80.0|0.75|2.34||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.34|0.75|0.2658
71126017|NCT03178669|141757998|SUPERIORITY||Odds Ratio (OR)|0.6||||0.8301|TWO_SIDED|80.0|0.36|1.16||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.16|0.36|0.8301
71126018|NCT03178669|141757999|SUPERIORITY||Odds Ratio (OR)|0.6||||0.7994|TWO_SIDED|80.0|0.32|1.27||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.27|0.32|0.7994
71126019|NCT03178669|141757999|SUPERIORITY||Odds Ratio (OR)|0.3||||0.9665|TWO_SIDED|80.0|0.16|0.72||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||0.72|0.16|0.9665
71126020|NCT03178669|141757999|SUPERIORITY||Odds Ratio (OR)|1.5||||0.2049|TWO_SIDED|80.0|0.8|2.82||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.82|0.80|0.2049
71126021|NCT03178669|141757999|SUPERIORITY||Odds Ratio (OR)|0.8||||0.6504|TWO_SIDED|80.0|0.42|1.6||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.60|0.42|0.6504
71126022|NCT03178669|141758000|SUPERIORITY||Odds Ratio (OR)|0.4||||0.9207|TWO_SIDED|80.0|0.18|0.93||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||0.93|0.18|0.9207
71126023|NCT03178669|141758000|SUPERIORITY||Odds Ratio (OR)|0.4||||0.9228|TWO_SIDED|80.0|0.19|0.92||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||0.92|0.19|0.9228
71126024|NCT03178669|141758000|SUPERIORITY||Odds Ratio (OR)|0.8||||0.6636|TWO_SIDED|80.0|0.39|1.61||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.61|0.39|0.6636
71126025|NCT03178669|141758000|SUPERIORITY||Odds Ratio (OR)|0.7||||0.7449|TWO_SIDED|80.0|0.34|1.41||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.41|0.34|0.7449
70946267|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2207|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 24 h PS;||||0.2207
70946268|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8055|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 24 h PS;||||0.8055
71088595|NCT01618968|141683529|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability comparisons were performed at each dose level.|Test / Reference ratio|94.83|||||TWO_SIDED|90.0|86.42|104.06||||||To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the abdomen using the VIBEX MTX device by measuring the maximum observed concentration (Cmax)||104.06|86.42|
71088596|NCT01618968|141683529|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability comparisons were performed at each dose level.|Test / Reference Ratio|82.12|||||TWO_SIDED|90.0|76.16|88.55||||||To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the thigh using the VIBEX MTX device by measuring the maximum observed concentration (Cmax)||88.55|76.16|
71088597|NCT01618968|141683529|NON_INFERIORITY_OR_EQUIVALENCE|Test of bioequivalence was performed at each dose level.|Test / Reference Ratio|115.63|||||TWO_SIDED|90.0|108.83|122.86||||||To compare the relative bioavailability of MTX following SC injection into the abdomen to that obtained after SC injection into the thigh using the VIBEX MTX device by measuring the maximum observed concentration (Cmax)||122.86|108.83|
71088598|NCT00721799|141683530|OTHER||Hazard Ratio (HR)|0.47||||0.08|TWO_SIDED||||||Regression, Cox|||||||0.08
71088599|NCT00721799|141683530|OTHER||C-statistic|0.73||||0.04|TWO_SIDED||||||Regression, Cox|||||||0.04
71088600|NCT00721799|141683531|OTHER||Hazard Ratio (HR)|0.42||||0.05|TWO_SIDED||||||Regression, Cox|||||||0.05
71088601|NCT00721799|141683531|OTHER||C-statistic|0.75||||0.02|TWO_SIDED||||||Regression, Cox|||||||0.02
71088602|NCT00721799|141683532|OTHER||Hazard Ratio (HR)|2.44|||<|0.01|TWO_SIDED||||||Regression, Cox|||||||<0.01
71088603|NCT00721799|141683532|OTHER||C-statistic|0.74||||0.02|TWO_SIDED||||||Regression, Cox|||||||0.02
71088604|NCT00721799|141683533|OTHER||Hazard Ratio (HR)|1.12||||0.73|TWO_SIDED||||||Regression, Cox|||||||0.73
70946269|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9191|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 72 h PS;||||0.9191
71088605|NCT00721799|141683533|OTHER||C-statistic|0.52||||0.88|TWO_SIDED||||||Regression, Cox|||||||0.88
71088606|NCT00721799|141683534|OTHER||Hazard Ratio (HR)|1.11||||0.78|TWO_SIDED||||||Regression, Cox|||||||0.78
71088607|NCT00721799|141683534|OTHER||C-statistic|0.45||||0.66|TWO_SIDED||||||Regression, Cox|||||||0.66
71088608|NCT00721799|141683535|OTHER||Hazard Ratio (HR)|2.25||||0.01|TWO_SIDED||||||Regression, Cox|||||||0.01
71088609|NCT00721799|141683535|OTHER||C-statistic|0.7||||0.05|TWO_SIDED||||||Regression, Cox|||||||0.05
71088610|NCT00721799|141683536|OTHER||Hazard Ratio (HR)|0.83||||0.63|TWO_SIDED||||||Regression, Cox|||||||0.63
71088611|NCT00721799|141683536|OTHER||C-statistic|0.58||||0.46|TWO_SIDED||||||Regression, Cox|||||||0.46
71088612|NCT00721799|141683537|OTHER||Hazard Ratio (HR)|0.81||||0.58|TWO_SIDED||||||Regression, Cox|||||||0.58
71088613|NCT00721799|141683537|OTHER||C-statistic|0.6||||0.36|TWO_SIDED||||||Regression, Cox|||||||0.36
71088614|NCT00721799|141683538|OTHER||Hazard Ratio (HR)|0.94||||0.89|TWO_SIDED||||||Regression, Cox|||||||0.89
71088615|NCT00721799|141683538|OTHER||C-statistic|0.59||||0.42|TWO_SIDED||||||Regression, Cox|||||||0.42
71088616|NCT00721799|141683539|OTHER||Hazard Ratio (HR)|1.29||||0.43|TWO_SIDED||||||Regression, Cox|||||||0.43
71088617|NCT00721799|141683539|OTHER||C-statistic|0.47||||0.8|TWO_SIDED||||||Regression, Cox|||||||0.80
71088618|NCT00721799|141683540|OTHER||Hazard Ratio (HR)|2.01||||0.01|TWO_SIDED||||||Regression, Cox|||||||0.01
71088619|NCT00721799|141683540|OTHER||C-statistic|0.69||||0.07|TWO_SIDED||||||Regression, Cox|||||||0.07
71088620|NCT00721799|141683541|OTHER||Hazard Ratio (HR)|1.58||||0.18|TWO_SIDED||||||Regression, Cox|||||||0.18
71088621|NCT00721799|141683541|OTHER||C-statistic|0.63||||0.25|TWO_SIDED||||||Regression, Cox|||||||0.25
71088622|NCT00721799|141683542|OTHER||Hazard Ratio (HR)|1.49||||0.24|TWO_SIDED||||||Regression, Cox|||||||0.24
71088623|NCT00721799|141683542|OTHER||C-statistic|0.62||||0.27|TWO_SIDED||||||Regression, Cox|||||||0.27
71088624|NCT00721799|141683543|OTHER||Hazard Ratio (HR)|1.0||||0.99|TWO_SIDED||||||Regression, Cox|||||||0.99
71088625|NCT00721799|141683543|OTHER||C-statistic|0.48||||0.84|TWO_SIDED||||||Regression, Cox|||||||0.84
71088626|NCT00721799|141683544|OTHER||Hazard Ratio (HR)|1.3||||0.41|TWO_SIDED||||||Regression, Cox|||||||0.41
71088627|NCT00721799|141683544|OTHER||C-statistic|0.54||||0.69|TWO_SIDED||||||Regression, Cox|||||||0.69
71088628|NCT00721799|141683545|OTHER||Hazard Ratio (HR)|1.56||||0.17|TWO_SIDED||||||Regression, Cox|||||||0.17
71088629|NCT00721799|141683545|OTHER||C-statistic|0.64||||0.18|TWO_SIDED||||||Regression, Cox|||||||0.18
71088630|NCT00721799|141683546|OTHER||Hazard Ratio (HR)|0.42||||0.09|TWO_SIDED||||||Regression, Cox|||||||0.09
71088631|NCT00721799|141683546|OTHER||Hazard Ratio (HR)|0.72||||0.06|TWO_SIDED||||||Regression, Cox|||||||0.06
71088632|NCT00721799|141683547|OTHER||Hazard Ratio (HR)|0.36||||0.06|TWO_SIDED||||||Regression, Cox|||||||0.06
71088633|NCT00721799|141683547|OTHER||C-statistic|0.74||||0.04|TWO_SIDED||||||Regression, Cox|||||||0.04
71088634|NCT00721799|141683548|OTHER||Hazard Ratio (HR)|3.01|||<|0.01|TWO_SIDED||||||Regression, Cox|||||||<0.01
71088635|NCT00721799|141683548|OTHER||C-statistic|0.82|||<|0.01|TWO_SIDED||||||Regression, Cox|||||||<0.01
71088636|NCT00721799|141683549|OTHER||Hazard Ratio (HR)|1.03||||0.92|TWO_SIDED||||||Regression, Cox|||||||0.92
71088637|NCT00721799|141683549|OTHER||C-statistic|0.48||||0.84|TWO_SIDED||||||Regression, Cox|||||||0.84
71088638|NCT00721799|141683550|OTHER||Hazard Ratio (HR)|1.11||||0.76|TWO_SIDED||||||Regression, Cox|||||||0.76
71088639|NCT00721799|141683550|OTHER||C-statistic|0.45||||0.68|TWO_SIDED||||||Regression, Cox|||||||0.68
71088640|NCT00721799|141683551|OTHER||Hazard Ratio (HR)|2.99|||<|0.01|TWO_SIDED||||||Regression, Cox|||||||<0.01
71088641|NCT00721799|141683551|OTHER||C-statistic|0.74||||0.03|TWO_SIDED||||||Regression, Cox|||||||0.03
71088642|NCT00721799|141683552|OTHER||Hazard Ratio (HR)|0.78||||0.55|TWO_SIDED||||||Regression, Cox|||||||0.55
71088643|NCT00721799|141683552|OTHER||C-statistic|0.61||||0.35|TWO_SIDED||||||Regression, Cox|||||||0.35
71088644|NCT00721799|141683553|OTHER||Hazard Ratio (HR)|0.74||||0.48|TWO_SIDED||||||Regression, Cox|||||||0.48
71088645|NCT00721799|141683553|OTHER||C-statistic|0.63||||0.28|TWO_SIDED||||||Regression, Cox|||||||0.28
71088646|NCT00721799|141683554|OTHER||Hazard Ratio (HR)|0.81||||0.67|TWO_SIDED||||||Regression, Cox|||||||0.67
71088647|NCT00721799|141683554|OTHER||C-statistic|0.71||||0.11|TWO_SIDED||||||Regression, Cox|||||||0.11
71088648|NCT00721799|141683555|OTHER||Hazard Ratio (HR)|1.32||||0.4|TWO_SIDED||||||Regression, Cox|||||||0.40
71088649|NCT00721799|141683555|OTHER||C-statistic|0.48||||0.88|TWO_SIDED||||||Regression, Cox|||||||0.88
71088650|NCT00721799|141683556|OTHER||Hazard Ratio (HR)|2.39|||<|0.01|TWO_SIDED||||||Regression, Cox|||||||<0.01
71088651|NCT00721799|141683556|OTHER||C-statistic|0.74||||0.03|TWO_SIDED||||||Regression, Cox|||||||0.03
71088652|NCT00721799|141683557|OTHER||Hazard Ratio (HR)|1.51||||0.26|TWO_SIDED||||||Regression, Cox|||||||0.26
71088653|NCT00721799|141683557|OTHER||C-statistic|0.59||||0.46|TWO_SIDED||||||Regression, Cox|||||||0.46
71088654|NCT00721799|141683558|OTHER||Hazard Ratio (HR)|1.38||||0.37|TWO_SIDED||||||Regression, Cox|||||||0.37
71088655|NCT00721799|141683558|OTHER||C-statistic|0.59||||0.46|TWO_SIDED||||||Regression, Cox|||||||0.46
71088656|NCT00721799|141683559|OTHER||Hazard Ratio (HR)|1.05||||0.9|TWO_SIDED||||||Regression, Cox|||||||0.90
71088657|NCT00721799|141683559|OTHER||C-statistic|0.52||||0.87|TWO_SIDED||||||Regression, Cox|||||||0.87
71088658|NCT00721799|141683560|OTHER||Hazard Ratio (HR)|1.35||||0.36|TWO_SIDED||||||Regression, Cox|||||||0.36
71088659|NCT00721799|141683560|OTHER||C-statistic|0.56||||0.63|TWO_SIDED||||||Regression, Cox|||||||0.63
70857570|NCT00402233|141201181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.14||||0.014||95.0|0.23|2.04|||ANCOVA|||||2.04|0.23|0.014
71088660|NCT00721799|141683561|OTHER||Hazard Ratio (HR)|1.56||||0.2|TWO_SIDED||||||Regression, Cox|||||||0.20
71088661|NCT00721799|141683561|OTHER||C-statistic|0.63||||0.24|TWO_SIDED||||||Regression, Cox|||||||0.24
71088662|NCT04356937|141683593|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.64|TWO_SIDED|95.0|0.38|1.81|||Log Rank|||||1.81|0.38|0.64
71088663|NCT04356937|141683594|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.73|TWO_SIDED|95.0|0.59|2.1|||Log Rank|||||2.10|0.59|0.73
71088664|NCT04356937|141683595|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.69|TWO_SIDED|95.0|0.67|1.3|||Log Rank|||||1.30|0.67|0.69
71088665|NCT03533751|141683602|SUPERIORITY||Least Squares (LS) Mean Difference|7.75|STANDARD_ERROR_OF_MEAN|10.235||0.4498|TWO_SIDED|95.0|-12.4066|27.8983|||ANCOVA|The p-value was obtained using a mixed effect analysis of covariance (ANCOVA) model with treatment as fixed effect and Baseline EASI as covariate.|Difference = Etokimab - Placebo|||27.8983|-12.4066|0.4498
71088666|NCT03533751|141683602|SUPERIORITY||LS Mean Difference|-6.32|STANDARD_ERROR_OF_MEAN|9.39||0.501|TWO_SIDED|95.0|-24.774|12.1262|||ANCOVA|The p-value was obtained using a mixed effect ANCOVA model with treatment as fixed effect and Baseline EASI as covariate.|Difference = Etokimab - Placebo|||12.1262|-24.7740|0.5010
71088667|NCT03533751|141683602|SUPERIORITY||LS Mean Difference|1.97|STANDARD_ERROR_OF_MEAN|9.454||0.8349|TWO_SIDED|95.0|-16.6037|20.5476|||ANCOVA|The p-value was obtained using a mixed effect ANCOVA model with treatment as fixed effect and Baseline EASI as covariate.|Difference = Etokimab - Placebo|||20.5476|-16.6037|0.8349
71088668|NCT03533751|141683602|SUPERIORITY||LS Mean Difference|4.82|STANDARD_ERROR_OF_MEAN|11.154||0.6662|TWO_SIDED|95.0|-17.1892|26.8275|||ANCOVA|The p-value was obtained using a mixed effect ANCOVA model with treatment as fixed effect and Baseline EASI as covariate.|Difference = Etokimab - Placebo|||26.8275|-17.1892|0.6662
71088669|NCT03533751|141683603|SUPERIORITY||Odds Ratio (OR)|0.91||||0.7992|TWO_SIDED|95.0|0.42|1.9509|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||1.9509|0.4200|0.7992
71088670|NCT03533751|141683603|SUPERIORITY||Odds Ratio (OR)|1.59||||0.2197|TWO_SIDED|95.0|0.757|3.3572|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||3.3572|0.7570|0.2197
71088671|NCT03533751|141683603|SUPERIORITY||Odds Ratio (OR)|1.15||||0.7197|TWO_SIDED|95.0|0.5345|2.4774|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||2.4774|0.5345|0.7197
70857571|NCT00402233|141201181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.03||95.0|0.094|1.9|||ANCOVA|||||1.9|0.094|0.03
70946270|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8488|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 72 h PS;||||0.8488
70857572|NCT00402233|141201181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.49||||0.0019||95.0|0.56|2.43|||ANCOVA|||||2.43|0.56|0.0019
70857573|NCT00402233|141201182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.39||95.0|-1.82|0.71|||ANCOVA|||||0.71|-1.82|0.39
70857574|NCT00402233|141201182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.37||95.0|-1.84|0.69|||ANCOVA|||||0.69|-1.84|0.37
70857575|NCT00402233|141201182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.48||95.0|-1.78|0.84|||ANCOVA|||||0.84|-1.78|0.48
70857576|NCT04456153|141201201|SUPERIORITY|||||||0.17|||||||GLMM|||||||0.170
70946271|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 72 h PS;||||0.2482
70857577|NCT04456153|141201202|SUPERIORITY|||||||0.051|||||||GLMM|||||||0.051
70946272|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at EOT;||||0.2482
70946273|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2207|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at EOT;||||0.2207
70946274|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at EOT;||||0.2482
70857578|NCT04456153|141201205|SUPERIORITY|||||||0.68|||||||Chi-squared|||||||0.68
70857579|NCT04456153|141201206|SUPERIORITY|||||||0.76|||||||trapezoidal method|||||||0.76
70857580|NCT04721067|141201220|SUPERIORITY||Mean Difference (Net)|-2.27||||0.607|TWO_SIDED|95.0|-15.14|10.6|||Regression, Logistic|Adjusted for baseline values||||10.60|-15.14|0.607
70857581|NCT04721067|141201221|SUPERIORITY||Mean Difference (Net)|-2.99||||0.766|TWO_SIDED|95.0|-10.74|4.76|||ANCOVA|||||4.76|-10.74|0.766
70857582|NCT04721067|141201222|SUPERIORITY||Mean Difference (Net)|145.54||||0.465|TWO_SIDED|95.0|-264.05|555.14|||ANCOVA|||||555.14|-264.05|0.465
70857583|NCT04721067|141201223|SUPERIORITY||Mean Difference (Net)|137.79||||0.178|TWO_SIDED|95.0|-68.71|344.3|||ANCOVA|||||344.30|-68.71|0.178
70857584|NCT04721067|141201224|SUPERIORITY||Mean Difference (Net)|1.87||||0.548|TWO_SIDED|95.0|-4.58|8.31|||ANCOVA|||||8.31|-4.58|0.548
70857585|NCT04721067|141201225|SUPERIORITY||Mean Difference (Net)|-0.67||||0.579|TWO_SIDED|95.0|-3.14|1.8|||ANCOVA|||||1.80|-3.14|0.579
70857586|NCT04721067|141201226|SUPERIORITY||Mean Difference (Net)|-0.63||||0.766|TWO_SIDED|95.0|-5.0|3.74|||ANCOVA|||||3.74|-5.00|0.766
70857587|NCT04721067|141201227|SUPERIORITY||Mean Difference (Net)|-1.23||||0.42|TWO_SIDED|95.0|-4.39|1.93|||ANCOVA|||||1.93|-4.39|0.42
70857588|NCT04721067|141201228|SUPERIORITY||Mean Difference (Net)|-0.07||||0.91|TWO_SIDED|95.0|-1.34|1.2|||ANCOVA|||||1.20|-1.34|0.91
70857589|NCT04721067|141201229|SUPERIORITY||Mean Difference (Net)|0.79||||0.73|TWO_SIDED|95.0|-4.03|5.6|||ANCOVA|||||5.60|-4.03|0.73
70857590|NCT04721067|141201230|SUPERIORITY||Mean Difference (Net)|0.19||||0.42|TWO_SIDED|95.0|-0.3|0.68|||ANCOVA|||||0.68|-0.30|0.42
70857591|NCT04721067|141201231|SUPERIORITY||Mean Difference (Net)|1.79||||0.18|TWO_SIDED|95.0|-0.9|4.48|||ANCOVA|||||4.48|-0.90|0.18
70857592|NCT04721067|141201232|SUPERIORITY||Mean Difference (Net)|-2.03||||0.48|TWO_SIDED|95.0|-7.97|3.9|||ANCOVA|||||3.90|-7.97|0.48
71088672|NCT03533751|141683603|SUPERIORITY||Odds Ratio (OR)|0.85||||0.6772|TWO_SIDED|95.0|0.391|1.8404|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||1.8404|0.3910|0.6772
71088673|NCT03533751|141683604|SUPERIORITY||Odds Ratio (OR)|1.03||||0.9537|TWO_SIDED|95.0|0.3922|2.6994|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||2.6994|0.3922|0.9537
71088674|NCT03533751|141683604|SUPERIORITY||Odds Ratio (OR)|1.57||||0.3316|TWO_SIDED|95.0|0.6323|3.8895|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||3.8895|0.6323|0.3316
71088675|NCT03533751|141683604|SUPERIORITY||Odds Ratio (OR)|1.36||||0.5166|TWO_SIDED|95.0|0.5331|3.4944|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||3.4944|0.5331|0.5166
71088676|NCT03533751|141683604|SUPERIORITY||Odds Ratio (OR)|1.17||||0.7426|TWO_SIDED|95.0|0.4545|3.0223|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||3.0223|0.4545|0.7426
71088677|NCT03533751|141683605|SUPERIORITY||Odds Ratio (OR)|1.76||||0.4543|TWO_SIDED|95.0|0.3998|7.7615|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||7.7615|0.3998|0.4543
71088678|NCT03533751|141683605|SUPERIORITY||Odds Ratio (OR)|2.57||||0.1874|TWO_SIDED|95.0|0.6314|10.4827|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||10.4827|0.6314|0.1874
71088679|NCT03533751|141683605|SUPERIORITY||Odds Ratio (OR)|2.69||||0.1721|TWO_SIDED|95.0|0.6506|11.0814|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||11.0814|0.6506|0.1721
71088680|NCT03533751|141683605|SUPERIORITY||Odds Ratio (OR)|0.68||||0.6755|TWO_SIDED|95.0|0.1086|4.2141|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||4.2141|0.1086|0.6755
71088681|NCT03533751|141683606|SUPERIORITY||Odds Ratio (OR)|0.75||||0.6058|TWO_SIDED|95.0|0.2481|2.2543|||Regression, Logistic|Logistic regression model with treatment as fixed effect and baseline vIGA-AD score as covariate.||||2.2543|0.2481|0.6058
71126026|NCT01600092|141758001|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is \>0.67|GMT Ratio (Experimental/Existing)|0.92|||||TWO_SIDED|95.0|0.79|1.07|||||GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups|Serotype G1||1.07|0.79|
71126027|NCT01600092|141758001|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is \>0.67|GMT Ratio (Experimental/Existing)|1.15|||||TWO_SIDED|95.0|0.99|1.33|||||GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups|Serotype G2||1.33|0.99|
71126028|NCT01600092|141758001|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is \>0.67|GMT Ratio (Experimental/Existing)|3.2|||||TWO_SIDED|95.0|2.75|3.74|||||GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups|Serotype G3||3.74|2.75|
70857593|NCT04721067|141201233|SUPERIORITY||Mean Difference (Net)|1.42||||0.08|TWO_SIDED|95.0|-0.24|3.08|||ANCOVA|||||3.08|-0.24|0.08
71088682|NCT03533751|141683606|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9521|TWO_SIDED|95.0|0.3356|2.7923|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline vIGA-AD score as a covariate.||||2.7923|0.3356|0.9521
71088683|NCT03533751|141683606|SUPERIORITY||Odds Ratio (OR)|1.23||||0.6905|TWO_SIDED|95.0|0.4457|3.3878|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline vIGA-AD score as a covariate.||||3.3878|0.4457|0.6905
71088684|NCT03533751|141683606|SUPERIORITY||Odds Ratio (OR)|1.04||||0.9399|TWO_SIDED|95.0|0.3671|2.9518|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline vIGA-AD score as a covariate.||||2.9518|0.3671|0.9399
71088685|NCT03533751|141683607|SUPERIORITY||Odds Ratio (OR)|1.22||||0.7659|TWO_SIDED|95.0|0.329|4.5268|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline vIGA-AD score as covariate.||||4.5268|0.3290|0.7659
71126029|NCT01600092|141758001|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is \>0.67|GMT Ratio (Experimental/Existing)|1.06|||||TWO_SIDED|95.0|0.94|1.2|||||GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups|Serotype G4||1.20|0.94|
71126030|NCT01600092|141758001|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is \>0.67|GMT Ratio (Experimental/Existing)|1.16|||||TWO_SIDED|95.0|1.0|1.35|||||GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups|Serotype P1A\[8\]||1.35|1.00|
70857594|NCT04721067|141201234|SUPERIORITY||Mean Difference (Net)|0.51||||0.94|TWO_SIDED|95.0|-13.5|14.52|||ANCOVA|||||14.52|-13.50|0.94
70857595|NCT04721067|141201237|SUPERIORITY||Mean Difference (Final Values)|0.43||||0.32|TWO_SIDED|95.0|-0.45|1.32|||t-test, 2 sided|||||1.32|-0.45|0.32
70857596|NCT04721067|141201238|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.61|TWO_SIDED|95.0|-0.75|1.25|||t-test, 2 sided|||||1.25|-0.75|0.61
70857597|NCT04721067|141201239|SUPERIORITY||Mean Difference (Net)|-1.05||||0.52|TWO_SIDED|95.0|-4.42|2.31|||ANCOVA|||||2.31|-4.42|0.52
70857598|NCT04721067|141201240|SUPERIORITY||Mean Difference (Net)|-0.44||||0.61|TWO_SIDED|95.0|-2.2|1.32|||ANCOVA|||||1.32|-2.20|0.61
70857599|NCT04721067|141201241|SUPERIORITY||Mean Difference (Net)|3.68||||0.16|TWO_SIDED|95.0|-1.61|8.97|||ANCOVA|||||8.97|-1.61|0.16
70857600|NCT04721067|141201242|SUPERIORITY||Mean Difference (Net)|0.43||||0.13|TWO_SIDED|95.0|-0.13|1.0|||ANCOVA|||||1.00|-0.13|0.13
71088686|NCT03533751|141683607|SUPERIORITY||Odds Ratio (OR)|1.36||||0.6273|TWO_SIDED|95.0|0.3895|4.776|||Regression, Logistic|Logistic regression model with treatment as fixed effect and baseline vIGA-AD score as covariate.||||4.7760|0.3895|0.6273
71126031|NCT00079677|141758006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.0003||95.0|1.67|5.46||The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group.|ANOVA|||Assumption: both primary treatment comparisons would be with a 2 sided test at an alpha level of 0.05||5.46|1.67|0.0003
71126032|NCT00079677|141758007|SUPERIORITY_OR_OTHER|||||||0.0069||||||The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group.|Cochran-Mantel-Haenszel|||Assumption: both primary treatment comparisons would be with a 2 sided test at an alpha level of 0.05.||||0.0069
71126033|NCT02641067|141758039|OTHER||Geometric mean ratio|1.43|||||TWO_SIDED|90.0|1.0|2.04||||||||2.04|1.00|
71126034|NCT02641067|141758040|OTHER||Geometric mean ratio|1.38|||||TWO_SIDED|90.0|0.99|1.92||||||||1.92|0.99|
71126035|NCT02641067|141758041|OTHER||Geometric mean ratio|0.83|||||TWO_SIDED|90.0|0.61|1.15||||||||1.15|0.61|
71126036|NCT02925728|141758049|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71126037|NCT00324233|141758057|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||equivalence testing|||||||0.56
71126038|NCT01707381|141758063|OTHER||Treatment difference|-1.773|||<|0.001|TWO_SIDED|95.0|-2.38|-1.166|||ANCOVA||Treatment Difference = BOL-303259-X 0.024% - Timolol maleate 0.5%.|||-1.166|-2.380|<0.001
71088687|NCT03533751|141683607|SUPERIORITY||Odds Ratio (OR)|1.88||||0.2967|TWO_SIDED|95.0|0.5734|6.1879|||Regression, Logistic|Logistic regression model with treatment as fixed effect and baseline vIGA-AD score as covariate.||||6.1879|0.5734|0.2967
71088688|NCT03533751|141683607|SUPERIORITY||Odds Ratio (OR)|1.46||||0.5544|TWO_SIDED|95.0|0.4152|5.1476|||Regression, Logistic|Logistic regression model with treatment as fixed effect and baseline vIGA-AD score as covariate.||||5.1476|0.4152|0.5544
71088689|NCT03533751|141683608|SUPERIORITY||Odds Ratio (OR)|1.12||||0.86|TWO_SIDED|95.0|0.3175|3.9513|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline peak weekly averaged NRS as covariate.||||3.9513|0.3175|0.8600
71126039|NCT01707381|141758064|OTHER||Bonferroni t-test used for paired compar|0.01|||<|0.05|TWO_SIDED||||||ANOVA||the bonferroni result applies to nocturnal supine OPP data comparing BOL group to timolol group|Statistical analysis of nocturnal (supine) OPP was performed among baseline, the BOL-303259-X treatment and timolol treatment using ANOVA. the criteria for statistical significance was P\<0.05. Post hoc Bonferroni T-tests were then utilized to compare BOL and timolol groups.||||<0.05
71126040|NCT01707381|141758065|OTHER||Mean Difference (Final Values)|-1.77||||0.004|TWO_SIDED|95.0|-2.915|-0.625|||ANOVA||Treatment Difference = BOL-303259-X 0.024% - Timolol maleate 0.5%.|||-0.625|-2.915|0.004
71126041|NCT00086411|141758067|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32|STANDARD_ERROR_OF_MEAN|0.2734|<|0.017|TWO_SIDED|95.0|0.77|2.25||The p-value was adjusted for multiple comparisons.|GEE model for repeated binary outcomes|Model included hx of heavy smoking, elevated depression, cigarettes per day, gender, and race|The above was for the main effect of BUP versus NTX on cessation.|Rates of abstinence were addressed using a generalized estimating equations (GEE) logistic regression model. Counseling type and medication type were entered as the main explanatory variables along with time and the interaction of these factors, together with some covariates (described below). The sample size provided 80% power to detect a difference of about 14% between groups across three time points (i.e., 12, 26, and 52 weeks post-treatment initiation.||2.25|0.77|<0.017
71126042|NCT00321464|141758120|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A synthesis method was used for the non-inferiority test for the hypothesis that denosumab preserves at least 50% of the effect of zoledronic acid vs. placebo.|Hazard Ratio (HR)|0.82|||<|0.0001||95.0|0.71|0.95|||Regression, Cox||Stratified by the randomization stratification factors (previous skeletal-related event, prior oral bisphosphonate use, current chemotherapy, and location in Japan).|||0.95|0.71|<0.0001
71126043|NCT00321464|141758121|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.01||95.0|0.71|0.95||P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure|Regression, Cox||Stratified by the randomization stratification factors (previous skeletal-related event, prior oral bisphosphonate use, current chemotherapy, and location in Japan).|||0.95|0.71|0.010
71126044|NCT00321464|141758122|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.77||||0.001||95.0|0.66|0.89||P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure|Anderson-Gill model||Stratified by the randomization stratification factors (previous skeletal-related event, prior oral bisphosphonate use, current chemotherapy, and location in Japan).|||0.89|0.66|0.001
71126045|NCT04327024|141758123|OTHER||Mean Difference (Final Values)|-0.1||||0.862|TWO_SIDED|95.0|-1.28|1.08|||ANCOVA|Model included change from baseline as the dependent variable, treatment as the independent variable and baseline peak VO2 as covariate.||||1.08|-1.28|0.862
71126046|NCT04327024|141758124|OTHER||Mean Difference (Final Values)|0.44||||0.472|TWO_SIDED|95.0|-0.76|1.64|||ANCOVA|Model included change from baseline as the dependent variable, treatment as the independent variable and baseline peak VO2 as covariate.||||1.64|-0.76|0.472
71088690|NCT03533751|141683608|SUPERIORITY||Odds Ratio (OR)|1.84||||0.3222|TWO_SIDED|95.0|0.5511|6.1214|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline peak weekly averaged NRS as covariate.||||6.1214|0.5511|0.3222
71088691|NCT03533751|141683608|SUPERIORITY||Odds Ratio (OR)|1.98||||0.2564|TWO_SIDED|95.0|0.6089|6.431|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline peak weekly averaged NRS as covariate.||||6.4310|0.6089|0.2564
71088692|NCT03533751|141683608|SUPERIORITY||Odds Ratio (OR)|1.89||||0.2912|TWO_SIDED|95.0|0.5806|6.1275|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline peak weekly averaged NRS as covariate.||||6.1275|0.5806|0.2912
71088693|NCT03533751|141683609|SUPERIORITY||LS Mean Difference|-1.17|STANDARD_ERROR_OF_MEAN|8.679||0.8927|TWO_SIDED|95.0|-18.2117|15.8686|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline weekly averaged peak NRS as covariate.|Difference = Etokimab - Placebo|||15.8686|-18.2117|0.8927
71088694|NCT03533751|141683609|SUPERIORITY||LS Mean Difference|3.43|STANDARD_ERROR_OF_MEAN|9.019||0.7035|TWO_SIDED|95.0|-14.2767|21.1463|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline weekly averaged peak NRS as covariate.|Difference = Etokimab - Placebo|||21.1463|-14.2767|0.7035
71088695|NCT03533751|141683609|SUPERIORITY||LS Mean Difference|-9.27|STANDARD_ERROR_OF_MEAN|8.608||0.2819|TWO_SIDED|95.0|-26.159|7.6237|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline weekly averaged peak NRS as covariate.|Difference = Etokimab - Placebo|||7.6237|-26.1590|0.2819
71088696|NCT03533751|141683609|SUPERIORITY||LS Mean Difference|-6.06|STANDARD_ERROR_OF_MEAN|8.557||0.4793|TWO_SIDED|95.0|-22.8452|10.7333|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline weekly averaged peak NRS as covariate.|Difference = Etokimab - Placebo|||10.7333|-22.8452|0.4793
71088697|NCT03533751|141683610|SUPERIORITY||LS Mean Difference|6.57|STANDARD_ERROR_OF_MEAN|6.677||0.3262|TWO_SIDED|95.0|-6.5723|19.7054|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline SCORAD as covariate.|Difference = Etokimab - Placebo|||19.7054|-6.5723|0.3262
71088698|NCT03533751|141683610|SUPERIORITY||LS Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|6.366||0.8465|TWO_SIDED|95.0|-13.7439|11.2782|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline SCORAD as covariate.|Difference = Etokimab - Placebo|||11.2782|-13.7439|0.8465
71088699|NCT03533751|141683610|SUPERIORITY||LS Mean Difference|2.51|STANDARD_ERROR_OF_MEAN|6.396||0.6947|TWO_SIDED|95.0|-10.0587|15.082|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline SCORAD as covariate.||||15.0820|-10.0587|0.6947
71088700|NCT03533751|141683610|SUPERIORITY||LS Mean Difference|6.76|STANDARD_ERROR_OF_MEAN|6.909||0.3288|TWO_SIDED|95.0|-6.8451|20.3626|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline SCORAD as covariate.|Difference = Etokimab - Placebo|||20.3626|-6.8451|0.3288
71088701|NCT03533751|141683611|SUPERIORITY||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|1.355||0.8497|TWO_SIDED|95.0|-2.4081|2.9218|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline DLQI score as covariate.|Difference = Etokimab - Placebo|||2.9218|-2.4081|0.8497
71088702|NCT03533751|141683611|SUPERIORITY||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|1.35||0.5016|TWO_SIDED|95.0|-3.5636|1.7473|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline DLQI score as covariate.|Difference = Etokimab - Placebo|||1.7473|-3.5636|0.5016
71088703|NCT03533751|141683611|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|1.386||0.7511|TWO_SIDED|95.0|-3.167|2.287|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline DLQI score as covariate.|Difference = Etokimab - Placebo|||2.2870|-3.1670|0.7511
71088704|NCT03533751|141683611|SUPERIORITY||LS Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|1.396||0.7558|TWO_SIDED|95.0|-2.3133|3.1824|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline DLQI score as covariate.|Difference = Etokimab - Placebo|||3.1824|-2.3133|0.7558
71088705|NCT00032591|141683635|NON_INFERIORITY_OR_EQUIVALENCE|A target of 363 patients with primary events required to discern a 32% relative drop in annual primary event rates with 90% power (from 5.5% for HQACM to 3.75% for PST) was based on a sample size of 3200 patients with 1 year of enrollment and a minimum of 2 years follow-up. Due to slower than planned enrollment, we randomized 2922 patients over 2.75 years, with a mean follow-up of 3 years.|Hazard Ratio (HR)|0.88||||0.14|||||||Log Rank|||The null hypothesis was the hazard ratio was equal to 1.||||0.14
71088706|NCT03312738|141683642|OTHER||Hazard Ratio (HR)|0.53|||||TWO_SIDED|90.0|0.4|0.71||||||||0.71|0.40|
71088707|NCT03312738|141683643|OTHER||Hazard Ratio (HR)|0.46|||||TWO_SIDED|90.0|0.32|0.67||||||||0.67|0.32|
71088708|NCT03312738|141683644|OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|90.0|0.69|1.89||||||||1.89|0.69|
71088709|NCT02014272|141683696|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|95.45|||||TWO_SIDED|90.0|92.07|98.94||||||Natural log transformed AUClast of rifampicin was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.||98.94|92.07|
71088710|NCT02014272|141683696|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|103.45|||||TWO_SIDED|90.0|99.33|107.75||||||Natural log transformed AUClast of isoniazid was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.||107.75|99.33|
70857601|NCT04721067|141201243|SUPERIORITY||Mean Difference (Net)|3.88||||0.03|TWO_SIDED|95.0|0.35|7.41|||ANCOVA|||||7.41|0.35|0.03
70946275|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3291|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 3 h PS;||||0.3291
70946276|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1391|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 3 h PS;||||0.1391
70946277|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6318|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 3 h PS;||||0.6318
70946278|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6319|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 24 h PS;||||0.6319
70946279|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8149|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 24 h PS;||||0.8149
70946280|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5795|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 24 h PS;||||0.5795
70946281|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.175|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 72 h PS;||||0.1750
71088711|NCT02014272|141683697|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|91.63|||||TWO_SIDED|90.0|83.13|101.01||||||Natural log transformed Cmax of rifampicin was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.||101.01|83.13|
71088712|NCT02014272|141683697|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|107.58|||||TWO_SIDED|90.0|96.07|120.47||||||Natural log transformed Cmax of isoniazid was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.||120.47|96.07|
71088713|NCT02014272|141683698|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|95.92|||||TWO_SIDED|90.0|92.54|99.43||||||Natural log transformed AUC(0 - ∞) of rifampicin was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.||99.43|92.54|
71088714|NCT02014272|141683698|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|102.41|||||TWO_SIDED|90.0|98.76|106.19||||||Natural log transformed AUC(0 - ∞) of isoniazid was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.||106.19|98.76|
71126047|NCT04327024|141758125|OTHER||Mean Difference (Final Values)|3.15||||0.287|TWO_SIDED|95.0|-2.65|8.94|||Mixed Models Analysis|Model included treatment as the independent variable and visit, visit by treatment, and baseline KCCQ-TSS as covariates.||"H0: Difference in mean change from baseline in KCCQ-TSS (verinurad + allopurinol vs placebo) = 0 Ha: Difference in mean change from baseline in KCCQ-TSS (verinurad + allopurinol vs placebo) ≠ 0~A hierarchical test sequence was used for the confirmatory analysis of the primary and secondary objectives in order to address the issue of multiple testing and control the Type I error rate at an overall two-sided 0.05 level."||8.94|-2.65|0.287
71126048|NCT04327024|141758126|OTHER||Mean Difference (Final Values)|-0.15||||0.96|TWO_SIDED|95.0|-5.9|5.61|||Mixed Models Analysis|Model included treatment as the independent variable and visit, visit by treatment, and baseline KCCQ-TSS as covariates.||"H0: Difference in mean change from baseline in KCCQ-TSS (verinurad + allopurinol vs allopurinol) = 0 Ha: Difference in mean change from baseline in KCCQ-TSS (verinurad + allopurinol vs allopurinol) ≠ 0~A hierarchical test sequence was used for the confirmatory analysis of the primary and secondary objectives in order to address the issue of multiple testing and control the Type I error rate at an overall two-sided 0.05 level."||5.61|-5.90|0.960
71126049|NCT01192568|141758130|SUPERIORITY||Mean Difference (Final Values)|14.22|STANDARD_ERROR_OF_MEAN|4.612||0.0928|TWO_SIDED|95.0|-2.45|30.9|||ANCOVA|||||30.90|-2.45|0.0928
71126050|NCT01192568|141758131|SUPERIORITY||Mean Difference (Final Values)|34.92|STANDARD_ERROR_OF_MEAN|8.089||0.0054|TWO_SIDED|95.0|11.13|58.7|||ANCOVA|||||58.70|11.13|0.0054
70946282|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0676|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 72 h PS;||||0.0676
71126051|NCT01192568|141758132|SUPERIORITY||Mean Difference (Final Values)|32.59|STANDARD_ERROR_OF_MEAN|13.215||0.1739|TWO_SIDED|95.0|-14.89|80.07|||ANCOVA|||||80.07|-14.89|0.1739
71088715|NCT01248455|141683736|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||No patients obtained a 50% reduction in M-protein concentration and the study did not continue to the second stage of enrollment due to the lack of efficacy as defined by out criteria. This statistical analysis includes all participants (i.e., stable disease (SD), minimal response (MR), biochemical progression (BP), and progressive disease (PD)).||||0.56
71088716|NCT01079780|141683795|SUPERIORITY||Hazard Ratio (HR)|0.75|||||TWO_SIDED|||||||||||||
71088717|NCT01079780|141683796|SUPERIORITY|||||||0.27|||||||Chi-squared|||||||0.27
71088718|NCT01079780|141683798|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.55|TWO_SIDED||||||Log Rank|||||||0.55
71088719|NCT03435055|141683804|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Paired t-test were conducted on subject specific beta maps to identify changes in connectivity associated with nitrous oxide in SPM12. Hypothesis was that the results would be deemed significant at false discovery rate (FDR) cluster level corrected p \< 0.05 derived from a voxel-wise uncorrected p-value \< 0.001.||||0.001
71088720|NCT03435055|141683805|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||Paired t-test were conducted on subject specific beta maps to identify changes in connectivity associated with nitrous oxide in SPM12. Hypothesis was that results would be deemed significant at false discovery rate (FDR) cluster level corrected p \< 0.05 derived from a voxel-wise uncorrected p-value \< 0.001.||||0.006
71088721|NCT03435055|141683806|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||Paired-t tests were conducted to determine whether changes in stimulus intensity: post stimulus at baseline and under subanesthetic dose of nitrous oxide. Statistical tests were completed in SPSS 26 and determined by p \< 0.05.||||<0.01
71088722|NCT03435055|141683807|OTHER|Paired T-test comparing baseline to nitrous||||||0.0622|||||||Paired t-test|||Delta||||0.0622
71088723|NCT03435055|141683807|OTHER|Paired T-test comparing baseline to nitrous||||||0.0292|||||||Paired t-test|||Theta||||0.0292
71088724|NCT03435055|141683807|OTHER|Paired T-test comparing baseline to nitrous||||||0.5905|||||||Paired t-test|||Alpha comparison||||0.5905
71088725|NCT01178294|141683808|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||one-sided binomial exact test|||Summary statistics for the percentage of participants with serious bleeding episodes responsive at 24 hours after the initiation of treatment are presented, along with the 95% confidence interval (two-sided 95% Clopper-Pearson confidence interval).||||<0.001
71088726|NCT03176771|141683856|SUPERIORITY||Mean Difference (Final Values)|-3.6|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-4.5|-2.6|||Mixed-effect Model Repeated Measures|||"Control for multiplicity was accomplished through the a fixed-sequence testing procedure for Week 6 outcomes:~* AIMS dyskinesia total score mean change from baseline (CFB): MT-5199 80 mg vs. placebo.~* AIMS: MT-5199 40 mg vs. PBO. For a test result in the above list to be considered statistically significant, all of the test results higher in the list must have been significant at the 0.05 level of significance."||-2.6|-4.5|<0.001
71126052|NCT01192568|141758133|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.117||0.266|TWO_SIDED|95.0|-0.53|0.15|||ANCOVA|||Results from a pre-specified test (Kolmogorov-Smirnov test p \<= 0.05) determined that the Pre-Am3 and Post-Am3 OTG data should be analyzed separately for the primary analysis.||0.15|-0.53|0.2660
71126053|NCT01192568|141758133|SUPERIORITY||Mean Difference (Final Values)|-0.67||||0.007|TWO_SIDED|95.0|-1.13|-0.21|||t-test, 2 sided|||||-0.21|-1.13|0.0070
71126054|NCT00652951|141758134|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% confidence interval (CI) of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 1.|GMC ratio|0.89|||||TWO_SIDED|95.0|0.74|1.07|||ANOVA|||The 2-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 1.||1.07|0.74|
70857602|NCT04721067|141201244|SUPERIORITY||Mean Difference (Net)|-3.2||||0.41|TWO_SIDED|95.0|-11.07|4.66|||ANCOVA|||||4.66|-11.07|0.41
71088727|NCT03176771|141683856|SUPERIORITY||Median Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.0|-1.3|||Mixed-effect Model Repeated Measures|||||-1.3|-3.0|<0.001
71088728|NCT03176771|141683857|SUPERIORITY||Risk Difference (RD)|13.6||||0.027|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.027
71088729|NCT03176771|141683857|SUPERIORITY||Risk Difference (RD)|36.9|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71088730|NCT03176771|141683858|SUPERIORITY||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.6||0.013|TWO_SIDED|95.0|-2.7|-0.3|||Mixed-effect Model Repeated Measures|||||-0.3|-2.7|0.013
71088731|NCT03176771|141683858|SUPERIORITY||Mean Difference (Final Values)|-2.3|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-3.5|-1.1|||Mixed-effect Model Repeated Measures|||||-1.1|-3.5|<0.001
71088732|NCT03176771|141683859|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.021|TWO_SIDED|95.0|-0.7|-0.1|||ANOVA|||||-0.1|-0.7|0.021
71088733|NCT03176771|141683859|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.0|-0.3|||ANOVA|||||-0.3|-1.0|<0.001
71088734|NCT02662569|141683876|SUPERIORITY||LS Mean Treatment Difference|-70.29|STANDARD_ERROR_OF_MEAN|2.61|<|0.0001|TWO_SIDED|95.0|-75.43|-65.16||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-65.16|-75.43|<0.0001
71088735|NCT02662569|141683876|SUPERIORITY||LS Mean Treatment Difference|-70.04|STANDARD_ERROR_OF_MEAN|2.35|<|0.0001|TWO_SIDED|95.0|-74.67|-65.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-65.41|-74.67|<0.0001
71088736|NCT02662569|141683877|SUPERIORITY||LS Mean Treatment Difference|-71.77|STANDARD_ERROR_OF_MEAN|2.97|<|0.0001|TWO_SIDED|95.0|-77.61|-65.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-65.93|-77.61|<0.0001
71126055|NCT00652951|141758134|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 4.|GMC ratio|1.01|||||TWO_SIDED|95.0|0.84|1.23|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 4.||1.23|0.84|
70946283|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2943|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at EOT;||||0.2943
71126056|NCT00652951|141758134|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 5.|GMC ratio|0.98|||||TWO_SIDED|95.0|0.83|1.15|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 5.||1.15|0.83|
71126057|NCT00652951|141758134|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 6B.|GMC ratio|0.93|||||TWO_SIDED|95.0|0.69|1.26|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 6B.||1.26|0.69|
71126058|NCT00652951|141758134|NON_INFERIORITY|Non-inferiority criteria: The upper limit of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group Group), was lower than 2 for the pneumococcal vaccine serotype 7F.|GMC ratio|0.96|||||TWO_SIDED|95.0|0.82|1.13|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel Group groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 7F.||1.13|0.82|
71126059|NCT00652951|141758134|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 9V.|GMC ratio|0.95|||||TWO_SIDED|95.0|0.78|1.16|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 9V.||1.16|0.78|
71126060|NCT00652951|141758134|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 14.|GMC ratio|1.01|||||TWO_SIDED|95.0|0.85|1.21|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 14.||1.21|0.85|
71126061|NCT00652951|141758134|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 18C.|GMC ratio|1.61|||||TWO_SIDED|95.0|1.28|2.03|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over ), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 18C.||2.03|1.28|
71126062|NCT00652951|141758134|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 19F.|GMC ratio|1.06|||||TWO_SIDED|95.0|0.82|1.36|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 19F.||1.36|0.82|
71126063|NCT00652951|141758134|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 23F.|GMC ratio|0.92|||||TWO_SIDED|95.0|0.7|1.23|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa Group and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 23F.||1.23|0.7|
70946284|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0719|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at EOT;||||0.0719
70946285|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9283|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 3 h PS;||||0.9283
70857603|NCT04721067|141201245|SUPERIORITY||Mean Difference (Net)|1.7||||0.17|TWO_SIDED|95.0|-0.83|4.22|||ANCOVA|||||4.22|-0.83|0.17
71126064|NCT00652951|141758135|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for protein D.|GMC ratio|0.91|||||TWO_SIDED|95.0|0.77|1.06|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns protein D.||1.06|0.77|
71126065|NCT02593825|141758177|SUPERIORITY|Significance was based on α = .05. Hedges' g, corrected for small sample bias, was calculated as a measure of effect size using the model-predicted group differences in rate of change in the numerator and the pooled standard deviation estimated from the 3 or 12 month assessment (for short- and long-term effects, respectively) in the denominator.|Slope|1.14|||<|0.05|TWO_SIDED|||||Piecewise linear mixed modeling (LMM) was performed to address the study questions. LMM was necessary to account for repeated measures nested within children.|Mixed Models Analysis|||Also examined these groups in sub-groups of mildly delayed (\<2.5 Standard Deviations below the mean on motor Bayley score at baseline) and significantly motor delayed (\>2.5 Standard Deviations below the mean on motor Bayley score at baseline)|Piecewise modeling, using individually-varying timepoints, allowed separate slopes to be estimated across the intervention (baseline to 3 months) and post-intervention (3 to 12 months) phases, and accounted for variation in the time between assessments across children. All models controlled for intercept-level differences by site, as well as intercept- and slope-level differences by baseline-adjusted age and motor severity. Intervention effects were derived via intervention by slope interaction terms. Three-way interaction terms were subsequently added to the models to obtain intervention effects stratified by severity.|||<0.05
71126066|NCT02593825|141758178|SUPERIORITY||Mean Difference (Final Values)|0.192||||0.05|TWO_SIDED||||||Linear piecewise modeling|||||||.05
71126067|NCT02593825|141758179|SUPERIORITY||Slope|0.92|STANDARD_ERROR_OF_MEAN|0.47|<|0.05|TWO_SIDED||||||Mixed Models Analysis||data shown is for the 12 month time point for the severely delayed group comparison|Also examined these groups in sub-groups of mildly delayed (\<2.5 Standard Deviations below the mean on motor Bayley score at baseline) and significantly motor delayed (\>2.5 Standard Deviations below the mean on motor Bayley score at baseline)||||<0.05
71126068|NCT02593825|141758181|SUPERIORITY||Slope|1.02|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||Also examined these groups in sub-groups of mildly delayed (\<2.5SD below the mean on motor Bayley score at baseline) and significantly motor delayed (\>2.5SD below the mean on motor Bayley score at baseline)|LMM was necessary to account for repeated measures nested within children. Piecewise modeling, using individually-varying timepoints, allowed separate slopes to be estimated across the intervention (baseline to 3 months).|||<0.05
71126069|NCT02593825|141758182|SUPERIORITY||Slope|8.7|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||Also examined these groups in sub-groups of mildly delayed (\<2.5SD below the mean on motor Bayley score at baseline) and significantly motor delayed (\>2.5SD below the mean on motor Bayley score at baseline)|Piecewise modeling, using individually-varying timepoints, allowed separate slopes to be estimated across the intervention (baseline to 3 months)|||<0.05
71126070|NCT02593825|141758183|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.417|TWO_SIDED||||||Mixed Models Analysis|||||||0.417
71126071|NCT01206582|141758185|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||ANCOVA|||Comparison for day 3||||0.0002
71126072|NCT01206582|141758185|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||ANCOVA|||Comparison for day 7||||0.008
71126073|NCT01206582|141758186|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||ANCOVA|||Comparison for day 3||||0.0003
71126074|NCT01206582|141758193|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|||Comparison for Day 7||||<0.05
70857604|NCT04721067|141201246|SUPERIORITY||Mean Difference (Net)|3.49||||0.58|TWO_SIDED|95.0|-9.58|16.55|||ANCOVA|||||16.55|-9.58|0.58
70857605|NCT04721067|141201247|SUPERIORITY||Mean Difference (Net)|0.15||||0.74|TWO_SIDED|95.0|-0.79|1.1|||ANCOVA|||||1.10|-0.79|0.74
70857606|NCT04721067|141201248|SUPERIORITY||Mean Difference (Net)|129.077||||0.17|TWO_SIDED|95.0|-57.78|315.92|||ANCOVA|||||315.92|-57.78|0.17
70857607|NCT04721067|141201249|SUPERIORITY||Mean Difference (Net)|109.71||||0.31|TWO_SIDED|95.0|-108.37|327.78|||ANCOVA|||||327.78|-108.37|0.31
71088737|NCT02662569|141683877|SUPERIORITY||LS Mean Treatment Difference|-64.93|STANDARD_ERROR_OF_MEAN|2.56|<|0.0001|TWO_SIDED|95.0|-69.97|-59.89||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-59.89|-69.97|<0.0001
71088738|NCT02662569|141683878|SUPERIORITY||LS Mean Treatment Difference|-62.5|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-68.2|-56.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-56.9|-68.2|<0.0001
71088739|NCT02662569|141683878|SUPERIORITY||LS Mean Treatment Difference|-63.1|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|95.0|-68.4|-57.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-57.8|-68.4|<0.0001
71088740|NCT02662569|141683879|SUPERIORITY||LS Mean Treatment Difference|-63.6|STANDARD_ERROR_OF_MEAN|3.1|<|0.0001|TWO_SIDED|95.0|-69.7|-57.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-57.6|-69.7|<0.0001
71088741|NCT02662569|141683879|SUPERIORITY||LS Mean Treatment Difference|-58.8|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-64.3|-53.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-53.3|-64.3|<0.0001
71088742|NCT02662569|141683880|SUPERIORITY||LS Mean Treatment Difference|-60.9|STANDARD_ERROR_OF_MEAN|2.35|<|0.0001|TWO_SIDED|95.0|-65.51|-56.29||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-56.29|-65.51|<0.0001
71088743|NCT02662569|141683880|SUPERIORITY||LS Mean Treatment Difference|-59.4|STANDARD_ERROR_OF_MEAN|2.09|<|0.0001|TWO_SIDED|95.0|-63.52|-55.29||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-55.29|-63.52|<0.0001
71088744|NCT02662569|141683881|SUPERIORITY||LS Mean Treatment Difference|-61.64|STANDARD_ERROR_OF_MEAN|2.64|<|0.0001|TWO_SIDED|95.0|-66.82|-56.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-56.45|-66.82|<0.0001
71088745|NCT02662569|141683881|SUPERIORITY||LS Mean Treatment Difference|-54.22|STANDARD_ERROR_OF_MEAN|2.28|<|0.0001|TWO_SIDED|95.0|-58.7|-49.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-49.74|-58.70|<0.0001
71088746|NCT02662569|141683882|SUPERIORITY||LS Mean Treatment Difference|-56.93|STANDARD_ERROR_OF_MEAN|2.03|<|0.0001|TWO_SIDED|95.0|-60.93|-52.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-52.93|-60.93|<0.0001
71126075|NCT01206582|141758194|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|||Comparison for Day 7||||<0.05
71126076|NCT01206582|141758195|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANCOVA|||Comparison for Platelets on Day 4||||0.01
71126077|NCT01209078|141758222|SUPERIORITY_OR_OTHER||Difference|-22.2|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for end of therapy Clinical Success.||||
71126078|NCT01209078|141758222|SUPERIORITY_OR_OTHER||Difference|-24.0|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for Follow-up Clinical Success.||||
71126079|NCT01209078|141758223|SUPERIORITY_OR_OTHER||Difference|-35.0|||||TWO_SIDED|95.0|-60.6|-9.4|||Regression, Logistic|||||-9.4|-60.6|
71126080|NCT01209078|141758224|SUPERIORITY_OR_OTHER||Difference|-35.0|||||TWO_SIDED|95.0|-60.6|-9.4|||Regression, Logistic|||||-9.4|-60.6|
71088747|NCT02662569|141683882|SUPERIORITY||LS Mean Treatment Difference|-54.85|STANDARD_ERROR_OF_MEAN|1.87|<|0.0001|TWO_SIDED|95.0|-58.52|-51.18||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-51.18|-58.52|<0.0001
71126081|NCT01209078|141758227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-0.41|0.74|||Mixed Models Analysis|||GSK1322322 1500 mg versus Linezolid 600 mg for Day 2 exudate or pus score.||0.74|-0.41|
71126082|NCT01209078|141758227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|||||TWO_SIDED|95.0|-0.7|0.45|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 3 exudate or pus score.||0.45|-0.70|
71126083|NCT01209078|141758227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|||||TWO_SIDED|95.0|-0.74|0.43|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 4 exudate or pus score.||0.43|-0.74|
71126084|NCT01209078|141758227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|||||TWO_SIDED|95.0|-0.25|0.95|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 8 exudate or pus score.||0.95|-0.25|
70946286|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9024|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 3 h PS;||||0.9024
70946287|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7655|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 3 h PS;||||0.7655
70946288|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 24 h PS;||||1.0000
71126085|NCT01209078|141758227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-0.49|0.72|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 11 exudate or pus score.||0.72|-0.49|
71126086|NCT01209078|141758227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.53|0.66|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 7 Day Follow- up exudate or pus score.||0.66|-0.53|
71126087|NCT01209078|141758227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.65|0.58|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 28 Day Follow- up exudate or pus score.||0.58|-0.65|
71126088|NCT01209078|141758228|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.86|||||TWO_SIDED|95.0|-3.04|1.33|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 2 total SIS.||1.33|-3.04|
71126089|NCT01209078|141758228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|||||TWO_SIDED|95.0|-2.94|1.41|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 3 total SIS.||1.41|-2.94|
71126090|NCT01209078|141758228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.54|||||TWO_SIDED|95.0|-1.68|2.75|||||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 4 total SIS.||2.75|-1.68|
71126091|NCT01209078|141758228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.79|||||TWO_SIDED|95.0|-0.46|4.05|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 8 total SIS.||4.05|-0.46|
71126092|NCT01209078|141758228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.19|||||TWO_SIDED|95.0|-1.09|3.47|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 11 total SIS.||3.47|-1.09|
71126093|NCT01209078|141758228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|||||TWO_SIDED|95.0|-1.49|2.98|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 7 Day Follow-up total SIS.||2.98|-1.49|
71126094|NCT01209078|141758228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|||||TWO_SIDED|95.0|-2.09|2.52|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 28 Day Follow-up total SIS.||2.52|-2.09|
71126095|NCT01209078|141758229|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.86|||||TWO_SIDED|95.0|-3.04|1.33|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 2 total SIS.||1.33|-3.04|
71088748|NCT02662569|141683883|SUPERIORITY||LS Mean Treatment Difference|-57.06|STANDARD_ERROR_OF_MEAN|2.3|<|0.0001|TWO_SIDED|95.0|-61.59|-52.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-52.54|-61.59|<0.0001
71088749|NCT02662569|141683883|SUPERIORITY||LS Mean Treatment Difference|-49.42|STANDARD_ERROR_OF_MEAN|1.98|<|0.0001|TWO_SIDED|95.0|-53.31|-45.53||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-45.53|-53.31|<0.0001
71088750|NCT02662569|141683884|SUPERIORITY||LS Mean Treatment Difference|-41.53|STANDARD_ERROR_OF_MEAN|1.74|<|0.0001|TWO_SIDED|95.0|-44.95|-38.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-38.10|-44.95|<0.0001
71088751|NCT02662569|141683884|SUPERIORITY||LS Mean Treatment Difference|-39.5|STANDARD_ERROR_OF_MEAN|1.51|<|0.0001|TWO_SIDED|95.0|-42.47|-36.53||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-36.53|-42.47|<0.0001
71088752|NCT02662569|141683885|SUPERIORITY||LS Mean Treatment Difference|-42.22|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED|95.0|-46.02|-38.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-38.42|-46.02|<0.0001
71088753|NCT02662569|141683885|SUPERIORITY||LS Mean Treatment Difference|-35.89|STANDARD_ERROR_OF_MEAN|1.64|<|0.0001|TWO_SIDED|95.0|-39.12|-32.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-32.67|-39.12|<0.0001
71088754|NCT02662569|141683886|SUPERIORITY||LS Mean Treatment Difference|-44.09|STANDARD_ERROR_OF_MEAN|1.81|<|0.0001|TWO_SIDED|95.0|-47.64|-40.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-40.54|-47.64|<0.0001
71088755|NCT02662569|141683886|SUPERIORITY||LS Mean Treatment Difference|-43.67|STANDARD_ERROR_OF_MEAN|1.64|<|0.0001|TWO_SIDED|95.0|-46.9|-40.44||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-40.44|-46.90|<0.0001
71088756|NCT02662569|141683887|SUPERIORITY||LS Mean Treatment Difference|-43.94|STANDARD_ERROR_OF_MEAN|2.02|<|0.0001|TWO_SIDED|95.0|-47.9|-39.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-39.97|-47.90|<0.0001
71088757|NCT02662569|141683887|SUPERIORITY||LS Mean Treatment Difference|-40.56|STANDARD_ERROR_OF_MEAN|1.79|<|0.0001|TWO_SIDED|95.0|-44.08|-37.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-37.04|-44.08|<0.0001
71126096|NCT01209078|141758229|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.77|||||TWO_SIDED|95.0|-2.94|1.41|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 3 total SIS.||1.41|-2.94|
71126097|NCT01209078|141758229|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.54|||||TWO_SIDED|95.0|-1.68|2.75|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 4 total SIS.||2.75|-1.68|
71126098|NCT01209078|141758229|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.79|||||TWO_SIDED|95.0|-0.46|4.05|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 8 total SIS.||4.05|-0.46|
71126099|NCT01209078|141758229|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.19|||||TWO_SIDED|95.0|-1.09|3.47|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 11 total SIS.||3.47|-1.09|
71126100|NCT01209078|141758229|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74|||||TWO_SIDED|95.0|-1.49|2.98|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 7 Day Follow-up total SIS.||2.98|-1.49|
71126101|NCT01209078|141758229|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21|||||TWO_SIDED|95.0|-2.09|2.52|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 28 Day Follow-up total SIS.||2.52|-2.09|
71126102|NCT01209078|141758230|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-68.85|||||TWO_SIDED|95.0|-132.8|-4.95|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 2 wound area.||-4.95|-132.8|
70857608|NCT04721067|141201250|SUPERIORITY||Mean Difference (Net)|0.24||||0.92|TWO_SIDED|95.0|-4.52|5.0|||ANCOVA|||||5.00|-4.52|0.92
71126103|NCT01209078|141758230|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.06|||||TWO_SIDED|95.0|-66.54|60.43|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 3 wound area.||60.43|-66.54|
71126104|NCT01209078|141758230|SUPERIORITY_OR_OTHER||Median Difference (Net)|31.47|||||TWO_SIDED|95.0|-33.53|96.47|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 4 wound area.||96.47|-33.53|
71126105|NCT01209078|141758230|SUPERIORITY_OR_OTHER||Mean Difference (Net)|43.94|||||TWO_SIDED|95.0|-22.43|110.31|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 8 wound area.||110.31|-22.43|
71126106|NCT01209078|141758230|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.21|||||TWO_SIDED|95.0|-33.03|101.45|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 11 wound area.||101.45|-33.03|
71126107|NCT01209078|141758230|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.57|||||TWO_SIDED|95.0|-28.25|103.4|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 7 Day Follow-up wound area.||103.40|-28.25|
71126108|NCT01209078|141758230|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.4|||||TWO_SIDED|95.0|-30.77|105.56|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 28 Day Follow-up wound area.||105.56|-30.77|
71126109|NCT01209078|141758231|SUPERIORITY_OR_OTHER||Difference|-35.4|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for Staphylococcus aureus (all).||||
71126110|NCT01209078|141758231|SUPERIORITY_OR_OTHER||Difference|-37.5|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for MRSA.||||
71126111|NCT01209078|141758231|SUPERIORITY_OR_OTHER||Difference|-28.6|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for MSSA.||||
71126112|NCT01209078|141758231|SUPERIORITY_OR_OTHER||Difference|-66.7|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for Streptococcus pyogenes.||||
71126113|NCT01209078|141758231|SUPERIORITY_OR_OTHER||Difference|-25.0|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for Gram-negative pathogens.||||
71126114|NCT01209078|141758231|SUPERIORITY_OR_OTHER||Difference|-37.5|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for All pathogens.||||
71126115|NCT01209078|141758231|SUPERIORITY_OR_OTHER||Difference|2.2|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for No pathogens.||||
71126116|NCT00924508|141758233|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||Baseline and post-treatment comparison||||<0.001
70857609|NCT04721067|141201251|SUPERIORITY||Mean Difference (Net)|-1.11||||0.66|TWO_SIDED|95.0|-6.28|4.06|||ANCOVA|||||4.06|-6.28|0.66
71126117|NCT00924508|141758233|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||Baseline and post-treatment comparison||||<0.001
71126118|NCT00924508|141758233|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||Baseline and post-treatment comparison||||<0.001
71088758|NCT02662569|141683888|SUPERIORITY||LS Mean Treatment Difference|-58.2|STANDARD_ERROR_OF_MEAN|2.01|<|0.0001|TWO_SIDED|95.0|-62.15|-54.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-54.25|-62.15|<0.0001
70946289|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.846|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 24 h PS;||||0.8460
70857610|NCT02233478|141201252|OTHER||Mean Difference (Final Values)|0.001||||0.82|TWO_SIDED||||||t-test, 2 sided|||"Comparison of ellagic acid concentration 0 to 24 hours post-dose area under the curve was made to PJ alone vs. PJ with soy protein after intervention.~Due to the quality issue of soybean flour, data from this intervention group was not analyzed."||||0.82
70946290|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6419|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 24 h PS;||||0.6419
70946291|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9522|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 72 h PS;||||0.9522
71126119|NCT01754493|141758246|SUPERIORITY_OR_OTHER_LEGACY||Slope|-18.24|||<|0.05|TWO_SIDED|95.0|-23.44|-12.63|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in total MADRS symptom scores for MDD. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (wks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||-12.63|-23.44|<.05
71126120|NCT01754493|141758247|SUPERIORITY_OR_OTHER_LEGACY||Slope|-20.71|||<|0.05|TWO_SIDED|95.0|-27.44|-13.97|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in total GSRS symptom scores for IBS. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (wks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||-13.97|-27.44|<0.05
71126121|NCT01754493|141758248|SUPERIORITY_OR_OTHER_LEGACY||Slope|-1.59|||<|0.05|TWO_SIDED|95.0|-2.16|-1.03|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in CGI-MDD score. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||-1.03|-2.16|<0.05
71126122|NCT01754493|141758248|SUPERIORITY_OR_OTHER_LEGACY||Slope|-1.55|||<|0.05|TWO_SIDED|95.0|-1.99|-1.11|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in CGI-IBS score. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||-1.11|-1.99|<0.05
71126123|NCT01754493|141758249|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.03|||<|0.05|TWO_SIDED|95.0|-1.16|1.1|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in VAS score of overall pain. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||1.10|-1.16|<0.05
71126124|NCT01754493|141758249|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.47|||<|0.05|TWO_SIDED|95.0|-1.07|2.01|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample with all subjects dispensed medication (n=17). This repeated-measures mixed-effects regression analysis assessed the rate of change in VAS score of pain interfering with daily activities. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a 1st-order autocorrelation structure. Data from each time point (wks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis||2.01|-1.07|<0.05
70857611|NCT00873873|141201253|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||95.0|||||ANOVA|||Is there a difference in airway wall thickness among the 4 groups?||||0.2
71126125|NCT01754493|141758249|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.59|||<|0.05|TWO_SIDED|95.0|-2.28|1.1|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in VAS score of headaches. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||1.10|-2.28|<0.05
70857612|NCT00604214|141201264|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.088||||0.313|TWO_SIDED|95.0|0.923|1.283||No adjustment for multiple comparisons.|Chi-squared|||The study was planned to have 80% power to detect a 20% relative risk reduction in 28-day all-cause mortality in drotrecogin alpha (activated) compared to placebo. The final power was 75% because of the lower than anticipated placebo mortality.||1.283|0.923|0.313
70946292|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.58|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 72 h PS;||||0.5800
71088759|NCT02662569|141683888|SUPERIORITY||LS Mean Treatment Difference|-56.73|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED|95.0|-60.53|-52.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-52.93|-60.53|<0.0001
70857613|NCT00604214|141201265|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.93||||0.54|TWO_SIDED|95.0|0.737|1.173||No adjustments for multiple comparisons.|Chi-squared|||||1.173|0.737|0.540
70857614|NCT00604214|141201266|SUPERIORITY_OR_OTHER|||||||0.181||95.0||||No adjustments for multiple comparisons.|ANOVA|||||||0.181
71088760|NCT02662569|141683889|SUPERIORITY||LS Mean Treatment Difference|-58.21|STANDARD_ERROR_OF_MEAN|2.23|<|0.0001|TWO_SIDED|95.0|-62.59|-53.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-53.84|-62.59|<0.0001
71088761|NCT02662569|141683889|SUPERIORITY||LS Mean Treatment Difference|-51.7|STANDARD_ERROR_OF_MEAN|2.09|<|0.0001|TWO_SIDED|95.0|-55.81|-47.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-47.59|-55.81|<0.0001
70857615|NCT00604214|141201267|SUPERIORITY_OR_OTHER|||||||0.733||95.0||||No adjustments for multiple comparisons.|ANOVA|||||||0.733
70857616|NCT00604214|141201268|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||No adjustments for multiple comparisons.|ANOVA|||||||0.122
70946293|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7675|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 72 h PS;||||0.7675
70946294|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1672|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at EOT;||||0.1672
71088762|NCT02662569|141683890|SUPERIORITY||Treatment Difference|68.4|||<|0.0001|TWO_SIDED|95.0|60.4|74.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by entry statin therapy and geographic region.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||74.8|60.4|<0.0001
70946295|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9634|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at EOT;||||0.9634
71088763|NCT02662569|141683890|SUPERIORITY||Treatment Difference|71.9|||<|0.0001|TWO_SIDED|95.0|64.1|77.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by entry statin therapy and geographic region.|Treatment difference = Evolocumab QM - Placebo QM|||77.9|64.1|<0.0001
71088764|NCT02662569|141683891|SUPERIORITY||Treatment Difference|67.2|||<|0.0001|TWO_SIDED|95.0|58.9|73.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by entry statin therapy and geographic region.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||73.9|58.9|<0.0001
71088765|NCT02662569|141683891|SUPERIORITY||Treatment Difference|68.8|||<|0.0001|TWO_SIDED|95.0|60.6|75.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by entry statin therapy and geographic region.|Treatment difference = Evolocumab QM - Placebo QM|||75.3|60.6|<0.0001
71126126|NCT01754493|141758249|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.35|||<|0.05|TWO_SIDED|95.0|-1.56|0.87|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in VAS score of back pain. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||.87|-1.56|<0.05
70946296|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1161|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at EOT;||||0.1161
71088766|NCT02662569|141683892|SUPERIORITY||LS Mean Treatment Difference|-55.52|STANDARD_ERROR_OF_MEAN|18.85|<|0.0001|TWO_SIDED|95.0|-92.64|-18.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-18.40|-92.64|<0.0001
70946297|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0754|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 3 h PS;||||0.0754
71126127|NCT01754493|141758249|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.48|||<|0.05|TWO_SIDED|95.0|-2.0|1.03|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in VAS score of shoulder pain. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||1.03|-2.00|<0.05
70857617|NCT00604214|141201269|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.042||||0.556|TWO_SIDED|95.0|0.909|1.193||No adjustments for multiple comparisons.|Chi-squared|||||1.193|0.909|0.556
70857618|NCT00604214|141201270|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02||||0.758|TWO_SIDED|95.0|0.898|1.16||No adjustments for multiple comparisons.|Chi-squared|||||1.160|0.898|0.758
70857619|NCT00604214|141201272|SUPERIORITY_OR_OTHER|||||||0.788||95.0||||P-value is for Baseline, unadjusted for multiple comparisons.|ANOVA|||||||0.788
70857620|NCT00604214|141201272|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||P-value is for Day 28, unadjusted for multiple comparisons.|ANOVA|||||||0.730
70857621|NCT00604214|141201272|SUPERIORITY_OR_OTHER|||||||0.662||95.0||||P-value is for Day 90, unadjusted for multiple comparisons.|ANOVA|||||||0.662
70857622|NCT00604214|141201272|SUPERIORITY_OR_OTHER|||||||0.846||95.0||||P-value is for Day 180, unadjusted for multiple comparisons.|ANOVA|||||||0.846
70857623|NCT00604214|141201273|SUPERIORITY_OR_OTHER|||||||0.697||95.0||||P-value is for Baseline, unadjusted for multiple comparisons.|ANOVA|||||||0.697
70857624|NCT00604214|141201273|SUPERIORITY_OR_OTHER|||||||0.306||95.0||||P-value is for Day 28, unadjusted for multiple comparisons.|ANOVA|||||||0.306
70857625|NCT00604214|141201273|SUPERIORITY_OR_OTHER|||||||0.645||95.0||||P-value is for Day 90, unadjusted for multiple comparisons.|ANOVA|||||||0.645
70857626|NCT00604214|141201273|SUPERIORITY_OR_OTHER|||||||0.69||95.0||||P-value is for Day 180, unadjusted for multiple comparisons.|ANOVA|||||||0.690
70857627|NCT00604214|141201274|SUPERIORITY_OR_OTHER|||||||0.482||95.0||||P-value is for physical component at Baseline, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.482
70857628|NCT00604214|141201274|SUPERIORITY_OR_OTHER|||||||0.584||95.0||||P-value is for physical component at Day 28, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.584
70857629|NCT00604214|141201274|SUPERIORITY_OR_OTHER|||||||0.164||95.0||||P-value is for physical component at Day 90, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.164
70857630|NCT00604214|141201274|SUPERIORITY_OR_OTHER|||||||0.666||95.0||||P-value is for physical component at Day 180, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.666
70857631|NCT00604214|141201274|SUPERIORITY_OR_OTHER|||||||0.786||95.0||||P-value is for mental component at Baseline, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.786
70857632|NCT00604214|141201274|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||P-value is for mental component at Day 28, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.160
70946298|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0711|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 3 h PS;||||0.0711
71088767|NCT02662569|141683892|SUPERIORITY||LS Mean Treatment Difference|-50.77|STANDARD_ERROR_OF_MEAN|6.63|<|0.0001|TWO_SIDED|95.0|-63.82|-37.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-37.72|-63.82|<0.0001
71088768|NCT02662569|141683893|SUPERIORITY||LS Mean Treatment Difference|-62.46|STANDARD_ERROR_OF_MEAN|24.64|<|0.0001|TWO_SIDED|95.0|-110.89|-14.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-14.03|-110.89|<0.0001
71088769|NCT02662569|141683893|SUPERIORITY||LS Mean Treatment Difference|-45.32|STANDARD_ERROR_OF_MEAN|8.42|<|0.0001|TWO_SIDED|95.0|-61.87|-28.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-28.77|-61.87|<0.0001
71088770|NCT02662569|141683894|SUPERIORITY||LS Mean Treatment Difference|-18.02|STANDARD_ERROR_OF_MEAN|4.01||0.0002|TWO_SIDED|95.0|-25.89|-10.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-10.14|-25.89|0.0002
71088771|NCT02662569|141683894|SUPERIORITY||LS Mean Treatment Difference|-15.63|STANDARD_ERROR_OF_MEAN|3.08|<|0.0001|TWO_SIDED|95.0|-21.69|-9.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-9.58|-21.69|<0.0001
71088772|NCT02662569|141683895|SUPERIORITY||LS Mean Treatment Difference|-16.41|STANDARD_ERROR_OF_MEAN|14.18||0.0002|TWO_SIDED|95.0|-24.63|-8.19||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-8.19|-24.63|0.0002
71088773|NCT02662569|141683895|SUPERIORITY||LS Mean Treatment Difference|-12.31|STANDARD_ERROR_OF_MEAN|3.28|<|0.0001|TWO_SIDED|95.0|-18.76|-5.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-5.86|-18.76|<0.0001
70857633|NCT00604214|141201274|SUPERIORITY_OR_OTHER|||||||0.696||95.0||||P-value is for mental component at Day 90, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.696
70946299|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0711|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 3 h PS;||||0.0711
71126128|NCT01754493|141758250|SUPERIORITY_OR_OTHER_LEGACY||Slope|-4.38|||<|0.05|TWO_SIDED|95.0|-7.39|-1.36|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample with all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in PHQ-15 scores of somatization symptoms. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||-1.36|-7.39|<0.05
71126129|NCT01543776|141758251|NON_INFERIORITY|The above criteria for non-inferiority corresponds to a response rate in the low dose arm that is no more than 15% lower than the response rate in the high dose arm (i.e., non-inferiority margin of 15%), under the assumption that the log ratios are approximately normally distributed.|Mean Difference (Final Values)|0.3976|||<|0.1|ONE_SIDED|90.0|-0.1111|||Calculated p-value.|t-test, 1 sided||||||-0.1111|<0.10
71126130|NCT01543776|141758252|SUPERIORITY|||||||0.38|||||||Log Rank|||||||0.38
71126131|NCT01543776|141758253|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||0.13
71126132|NCT01543776|141758254|SUPERIORITY|||||||0.26|||||||Fisher Exact|||||||0.26
71126133|NCT01543776|141758255|SUPERIORITY|||||||0.012|||||||t-test, 2 sided|||||||0.012
71126134|NCT03055013|141758260|SUPERIORITY||Cox Proportional Hazard|0.95||||0.34|TWO_SIDED|95.0|0.74|1.22|||Log Rank|stratified logrank test (one-sided)|hazard ratio : arm A vs. arm B|||1.22|0.74|0.34
71126135|NCT02207491|141758272|NON_INFERIORITY|Clinical noninferiority was to be concluded if the upper limit of the 95% CIs around the difference (AR-13324 - timolol) was within 1.5 mmHg at all time points and was within 1.0 mmHg at a majority of the time points.|||||<|0.0001||||||Calculated p-value|ANCOVA|Statistical analysis applies at all 3 timepoints on Day 15, Day 43, and Day 90||Assuming zero difference between AR-13324 and timolol, a 2-tailed alpha of 0.05 at each of 9 time points, a common SD of 3.0 mmHg, and a correlation between time points of 0.60 or less, 170 PP subjects per arm were necessary to have 90% power to show clinical noninferiority of AR-13324 to timolol in mean IOP.||||<0.0001
71126136|NCT00126776|141758279|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||mean cumulative frequency|||primary outcome is mean cumulative frequency of COPD related hospitlaizations and ED visits ;ver 1 yr: 0.48 for disease management; 0.82 for usual care, difference 0.34 (95% CI 0.15 to 0.52; P\<0.001)||||< 0.001
71126137|NCT00599755|141758280|SUPERIORITY_OR_OTHER||Proportion|0.4|||||TWO_SIDED|80.0|0.27|0.55||||||||0.55|0.27|
71126138|NCT00599755|141758281|SUPERIORITY_OR_OTHER||Concordance correlation coefficient|0.88|||||TWO_SIDED|80.0|0.85|0.92||||||||0.92|0.85|
71126139|NCT00599755|141758285|SUPERIORITY_OR_OTHER||Proportion|0.125|||||TWO_SIDED|80.0|0.06|0.23||||||||0.23|0.06|
71126140|NCT02893917|141758290|SUPERIORITY||Hazard Ratio (HR)|0.617||||0.0359|TWO_SIDED|95.0|0.392|0.969|||Regression, Cox|||||0.969|0.392|0.0359
71126141|NCT02893917|141758291|SUPERIORITY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.705|2.399||no p value provided|Regression, Cox|||||2.399|0.705|
71126142|NCT02893917|141758294|OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.272|1.504|||Regression, Cox|||HRD positive ONLY||1.504|0.272|
71126143|NCT02893917|141758294|OTHER||Hazard Ratio (HR)|0.777|||||TWO_SIDED|95.0|0.448|1.348|||Regression, Cox|||HRD negative ONLY||1.348|0.448|
71126144|NCT03626545|141758300|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.633|TWO_SIDED|95.0|0.76|1.48|||Log Rank||Hazard ratio was estimated using a Cox Proportional Hazards regression model stratified by line of therapy and histology|||1.48|0.76|0.633
71126145|NCT01939366|141758324|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.37||0.0621|TWO_SIDED|95.0|-1.43|0.04||Due to the exploratory character of this trial, no multiple testing adjustment for control of the false positive rate was applied.|Mixed Models Analysis|The analysis consisted of the contrasts (mixed model Wald tests) of individual cebranopadol doses versus placebo during Week 6 of Maintenance Phase.||The mixed model repeated measurement (MMRM) model included fixed effects of pooled sites, treatment, week, treatment-by-week interaction, baseline pain, and a subject-specific random effect. The model was based on the weekly average 24-hour pain intensity of the 2 weeks in the Titration Phase and 6 weeks in the Maintenance Phase. An unstructured covariance matrix was used to model the covariance structure, denominator degrees of freedom were estimated using the Kenward-Roger approximation.||0.04|-1.43|0.0621
71088774|NCT02662569|141683896|SUPERIORITY||LS Mean Treatment Difference|6.34|STANDARD_ERROR_OF_MEAN|1.52||0.0003|TWO_SIDED|95.0|3.36|9.33||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||9.33|3.36|0.0003
70857634|NCT00604214|141201274|SUPERIORITY_OR_OTHER|||||||0.966||95.0||||P-value is for mental component at Day 180, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.966
70857635|NCT00604214|141201275|SUPERIORITY_OR_OTHER|||||||0.758||95.0||||P-value is for participants with ≥1 event. No adjustments for multiple comparisons.|Fisher Exact|||||||0.758
71088775|NCT02662569|141683896|SUPERIORITY||LS Mean Treatment Difference|7.87|STANDARD_ERROR_OF_MEAN|1.41|<|0.0001|TWO_SIDED|95.0|5.1|10.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||10.65|5.10|<0.0001
71088776|NCT02662569|141683897|SUPERIORITY||LS Mean Treatment Difference|5.88|STANDARD_ERROR_OF_MEAN|1.72||0.0003|TWO_SIDED|95.0|2.49|9.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||9.27|2.49|0.0003
70857636|NCT00604214|141201276|SUPERIORITY_OR_OTHER|||||||0.154||95.0||||Unadjusted for multiple comparisons.|Fisher Exact|||||||0.154
71088777|NCT02662569|141683897|SUPERIORITY||LS Mean Treatment Difference|8.14|STANDARD_ERROR_OF_MEAN|1.58|<|0.0001|TWO_SIDED|95.0|5.03|11.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||11.25|5.03|<0.0001
70946300|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 24 h PS;||||0.2482
70857637|NCT02233946|141201286|SUPERIORITY||Cox Proportional Hazard|0.69|||||TWO_SIDED|95.0|0.47|1.02||||||Participants who reported past-12-month use of alcohol or other drugs at baseline||1.02|0.47|
70857638|NCT02233946|141201286|SUPERIORITY||Cox Proportional Hazard|0.87|||||TWO_SIDED|95.0|0.57|1.31||||||Participants who reported no past-12-month use of alcohol or other drugs at baseline||1.31|0.57|
71088778|NCT02662569|141683898|SUPERIORITY||LS Mean Treatment Difference|-27.18|STANDARD_ERROR_OF_MEAN|3.57|<|0.0001|TWO_SIDED|95.0|-34.2|-20.17||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-20.17|-34.20|<0.0001
71088779|NCT02662569|141683898|SUPERIORITY||LS Mean Treatment Difference|-24.01|STANDARD_ERROR_OF_MEAN|2.99|<|0.0001|TWO_SIDED|95.0|-29.88|-18.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-18.14|-29.88|<0.0001
71088780|NCT00289211|141683899|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.048||||0.048||95.0|1.008|4.164|||Regression, Cox|||Subjects who did not experience beginning of substantial relief of the defining symptom within 4 hours after initial treatment were included in the analysis as censored observations. Entries of 4.0 (hours) for median time to event or 95% CI indicate that data were NE (see Population Description). As non-numeric data are not supported by the median and 95% CI fields, entry of the actual results (ie, NE or \>4.0) was not possible.||4.164|1.008|0.048
71088781|NCT00289211|141683900|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.41||||0.062||95.0|0.87|2.29|||Cochran-Mantel-Haenszel|||||2.29|0.87|0.062
71088782|NCT00289211|141683901|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.717||||0.001||95.0|1.471|5.02|||Regression, Cox|||Subjects who had not experienced complete resolution of the HAE attack at the time of the follow-up telephone call, or who were lost to follow-up, were censored at 72 hours.||5.020|1.471|0.001
71088783|NCT00289211|141683902|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
71088784|NCT00289211|141683902|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Change at 2 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
71088785|NCT00289211|141683902|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Change at 4 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
71088786|NCT00289211|141683902|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007||95.0||||Change at 12 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.0007
71088787|NCT00289211|141683903|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Percent change 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
71126146|NCT01939366|141758324|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.39||0.0564|TWO_SIDED|95.0|-1.5|0.02||Due to the exploratory character of this trial, no multiple testing adjustment for control of the false positive rate was applied.|Mixed Models Analysis|The analysis consisted of the contrasts (mixed model Wald tests) of individual cebranopadol doses versus placebo during Week 6 of Maintenance Phase.||The mixed model repeated measurement (MMRM) model included fixed effects of pooled sites, treatment, week, treatment-by-week interaction, baseline pain, and a subject-specific random effect. The model was based on the weekly average 24-hour pain intensity of the 2 weeks in the Titration Phase and 6 weeks in the Maintenance Phase. An unstructured covariance matrix was used to model the covariance structure, denominator degrees of freedom were estimated using the Kenward-Roger approximation.||0.02|-1.50|0.0564
71126147|NCT01939366|141758324|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|0.41||0.0153|TWO_SIDED|95.0|-1.83|-0.2||Due to the exploratory character of this trial, no multiple testing adjustment for control of the false positive rate was applied.|Mixed Models Analysis|The analysis consisted of the contrasts (mixed model Wald tests) of individual cebranopadol doses versus placebo during Week 6 of Maintenance Phase.||The mixed model repeated measurement (MMRM) model included fixed effects of pooled sites, treatment, week, treatment-by-week interaction, baseline pain, and a subject-specific random effect. The model was based on the weekly average 24-hour pain intensity of the 2 weeks in the Titration Phase and 6 weeks in the Maintenance Phase. An unstructured covariance matrix was used to model the covariance structure, denominator degrees of freedom were estimated using the Kenward-Roger approximation.||-0.20|-1.83|0.0153
71126148|NCT00151476|141758355|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|14.49||||||95.0|3.48|301.64|||||Kaplan-Meier Estimate of Time to Event (months).|"Time to FAP-related surgical events (months); twenty-fifth (25th) percentile presented due to limited number of subjects.~Index date based on most recent colon and or rectum adenomatous polyps evaluation, most recent duodenal adenomatous polyps evaluation, and most recent desmoids tumors evaluation for Matched Control, Not Matched Celecoxib, and All Celecoxib Treated, respectively.~Only 13 matched pairs identified: p-values not computed in analysis of time-to-event endpoints"||301.64|3.48|
71126149|NCT00151476|141758355|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|5.06||||||95.0|3.48|11.76|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||11.76|3.48|
71088788|NCT00289211|141683903|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Percent change 2 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
70946301|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8091|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 24 h PS;||||0.8091
71088789|NCT00289211|141683903|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Percent change 4 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
71088790|NCT00289211|141683903|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0022||95.0||||Percent change 12 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.0022
71088791|NCT00289211|141683904|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1321||95.0||||Change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.1321
71088792|NCT00289211|141683904|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5218||95.0||||Change at 2 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.5218
71088793|NCT00289211|141683904|SUPERIORITY_OR_OTHER_LEGACY|||||||0.121||95.0||||Change at 4 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.1210
71088794|NCT00289211|141683904|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017||95.0||||Change at 12 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.0017
71088795|NCT01924533|141684031|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79||||0.0262|TWO_SIDED|97.5|0.63|1.0|||Cox proportional hazards model|||||1.00|0.63|0.0262
70857639|NCT02233946|141201287|SUPERIORITY||Cox Proportional Hazard|0.66|||||TWO_SIDED|95.0|0.4|1.1||||||Participants who reported past-12-month use of alcohol or other drugs at baseline||1.10|0.40|
71126150|NCT00151476|141758355|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|5.52||||||95.0|3.48|14.49|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||14.49|3.48|
71126151|NCT00151476|141758356|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|5.98||||||95.0|0.0|33.77|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||33.77|0.00|
71126152|NCT00151476|141758356|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|19.81||||||95.0|0.0|33.77|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||33.77|0.00|
71126153|NCT00151476|141758357|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|137.34||||||95.0|104.73|183.48|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile. Index date based on most recent colon and or rectum adenomatous polyps evaluation, most recent duodenal adenomatous polyps evaluation, and most recent desmoids tumors evaluation for Matched Control, Not Matched Celecoxib, and All Celecoxib Treated, respectively.||183.48|104.73|
71126154|NCT00151476|141758357|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|169.94||||||95.0|104.73|183.48|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||183.48|104.73|
71126155|NCT00151476|141758358|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|11.28||||||95.0|9.07|38.24|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||38.24|9.07|
71126156|NCT00151476|141758359|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|20.63||||||95.0|8.05|48.03|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||48.03|8.05|
71126157|NCT00151476|141758359|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|40.21||||||95.0|8.31|105.68|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||105.68|8.31|
71126158|NCT00151476|141758359|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|19.81||||||95.0|16.03|56.34|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||56.34|16.03|
71126159|NCT00151476|141758359|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|20.22||||||95.0|12.35|40.31|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||40.31|12.35|
71126160|NCT00151476|141758361|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|21.22||||||95.0|4.07|64.16|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related events (months); 25th percentile.||64.16|4.07|
71126161|NCT00151476|141758361|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|19.81||||||95.0|3.68|64.16|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related events (months); 25th percentile.||64.16|3.68|
71126162|NCT03446456|141758368|EQUIVALENCE|An equivalence test was conducted to compare if the vasopressin group differed from the saline group in changes of BOLD signal in the brain.|Mean Difference (Final Values)|0.00264||||0.982|TWO_SIDED|||||Bonferroni corrected|t-test, 2 sided|||Percentage of BOLD signal change was calculated as the BOLD signal in the right supplementary motor area (SMA, a typical brain area responding to pain stimulation), divided by the BOLD signal of the whole-brain average during the 24 trials of 20-second painful stimulations. The percentage of BOLD signal changes in SMA during the 20-second painful stimulations were compared between the Saline group and the Vasopressin group using an equivalence test.||||0.982
71126163|NCT03446456|141758369|EQUIVALENCE|An equivalence test was conducted to compare if the vasopressin group differed from the saline group in heating temperature that was used for the testing phase.|Mean Difference (Final Values)|-0.282||||0.269|TWO_SIDED|||||Bonferroni corrected|ANCOVA|The drug group (Vasopressin vs. Saline) was set as a between-subject factor. Age and race were treated as covariates.||||||0.269
71126164|NCT03446456|141758370|EQUIVALENCE|An equivalence test was conducted to compare if the vasopressin group differed from the saline group in implicit racial biases.|Mean Difference (Final Values)|-0.04||||0.378|TWO_SIDED||||||ANCOVA|Drug group (Vasopressin vs. Saline) was set as between-subject factor. Age and race were treated as covariates.||"Response latencies were recorded to calculate the IAT difference score (D). A difference score (D) was calculated based on the following steps: 1) Compute the standard deviation (SD) of response latencies from overall trials; 2) M1 is the mean of the response latencies in the condition where White people and good share the same response key. M2 is the mean of the latencies in the condition where African-American/Asian people and good share the same response key; 3) D = (M2-M1)/SD."||||0.378
71126165|NCT03446456|141758371|EQUIVALENCE|An equivalence test was conducted to compare if the vasopressin group differed from the saline group in self-reported pain intensity ratings.|Mean Difference (Final Values)|-2.35||||0.014|TWO_SIDED|||||Bonferroni corrected|Mixed Models Analysis|Age, race, and heating temperature used during the testing phase were treated as covariates.||||||0.014
71126166|NCT04099511|141758393|SUPERIORITY|||||||0.693|||||||Wilcoxon (Mann-Whitney)|||||||.693
70946302|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 24 h PS;||||0.2482
71126167|NCT04099511|141758394|SUPERIORITY|||||||0.536|||||||Wilcoxon (Mann-Whitney)|||||||.536
71126168|NCT04099511|141758395|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||.260
71126169|NCT04099511|141758396|SUPERIORITY|||||||0.387|||||||Wilcoxon (Mann-Whitney)|||||||.387
71126170|NCT04099511|141758397|SUPERIORITY|||||||0.826|||||||Wilcoxon (Mann-Whitney)|||||||0.826
70857640|NCT02233946|141201288|SUPERIORITY|Participants who reported past-12-month use of alcohol or other drugs at baseline|Cox Proportional Hazard|0.62|||||TWO_SIDED|95.0|0.41|0.94||||||||0.94|0.41|
71126171|NCT04099511|141758398|SUPERIORITY|||||||0.826|||||||Wilcoxon (Mann-Whitney)|||||||0.826
71126172|NCT04099511|141758399|SUPERIORITY|||||||0.388|||||||Wilcoxon (Mann-Whitney)|||||||0.388
71126173|NCT04099511|141758400|SUPERIORITY|||||||0.308|||||||Wilcoxon (Mann-Whitney)|||||||0.308
71088796|NCT01924533|141684032|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.2458|TWO_SIDED|97.5|0.4|1.34|||Cox proportional hazards model|||||1.34|0.40|0.2458
71088797|NCT01924533|141684033|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.0645|TWO_SIDED|97.5|0.67|1.04|||Cox proportional hazards model|||||1.04|0.67|0.0645
71088798|NCT01924533|141684034|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.2199|TWO_SIDED|97.5|0.42|1.29|||Cox proportional hazards model|||||1.29|0.42|0.2199
71088799|NCT01924533|141684035|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.69||||0.0548|TWO_SIDED|97.5|0.92|3.17|||Regression, Logistic|||||3.17|0.92|0.0548
71088800|NCT01924533|141684036|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.24||||0.0309|TWO_SIDED|97.5|0.95|23.23|||Regression, Logistic|||||23.23|0.95|0.0309
71088801|NCT01924533|141684037|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.0716|TWO_SIDED|97.5|0.64|1.05|||Cox proportional hazards model|||||1.05|0.64|0.0716
71088802|NCT01924533|141684038|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.0927|TWO_SIDED|97.5|0.34|1.16|||Cox proportional hazards model|||||1.16|0.34|0.0927
71088803|NCT02747927|141684043|OTHER||Vaccine Efficacy (VE)|80.2|||<|0.001|TWO_SIDED|95.0|73.3|85.3||Statistical significance was concluded if the lower bound of the 95% CI for the VE was above 25%. Since the hypotheses was tested in a confirmatory manner at a 2-sided significance level of 5%, the calculated p-value was compared with 0.025.|Cox Proportional Hazard Model|VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.||Assuming true VE of 60% and, virologically confirmed cases of dengue fever induced by any dengue serotype occurring from 30 days post 2nd vaccination (Day 120) until end of Part 1 would provide at least 90% power to rule out vaccine effect of ≤25%.||85.3|73.3|<0.001
71088804|NCT05412134|141684059|OTHER|||||||0.333|||||||Chi-squared|||Repetition adherence||||0.333
71088805|NCT05412134|141684059|OTHER|||||||0.626|||||||Chi-squared|||Session adherence||||0.626
71088806|NCT05412134|141684060|SUPERIORITY|||||||0.416|||||||Wilcoxon (Mann-Whitney)|||||||0.416
71088807|NCT05412134|141684061|SUPERIORITY|||||||0.581|||||||t-test, 2 sided|||||||0.581
71088808|NCT05412134|141684062|SUPERIORITY|||||||0.071|||||||t-test, 2 sided|||||||0.071
71088809|NCT05412134|141684063|SUPERIORITY|||||||0.356|||||||t-test, 2 sided|||||||0.356
71088810|NCT05412134|141684065|SUPERIORITY|||||||0.079|||||||t-test, 2 sided|||||||0.079
71088811|NCT04275336|141684068|OTHER||H value|1.344||||0.511|TWO_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.511
71088812|NCT04275336|141684069|OTHER||H value|5.272||||0.072|TWO_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.072
71088813|NCT04275336|141684070|OTHER||H value|0.198||||0.906|ONE_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.906
71088814|NCT04275336|141684071|OTHER||H value|6.679||||0.035|TWO_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.035
71088815|NCT04275336|141684072|OTHER||Mean Difference (Final Values)|0.17||||0.844|TWO_SIDED|95.0||||\<0.05|ANOVA|||||||0.844
71088816|NCT04275336|141684073|OTHER||H value|1.651||||0.438|TWO_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.438
71088817|NCT04275336|141684074|OTHER||H value|0.341||||0.843|TWO_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.843
71088818|NCT04275336|141684075|OTHER||Median Difference (Final Values)|1.642||||0.44|TWO_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.440
71088819|NCT04664205|141684076|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.010
71088820|NCT04664205|141684077|SUPERIORITY|||||||0.069|||||||ANCOVA|||||||0.069
71088821|NCT04664205|141684078|SUPERIORITY|||||||0.478|||||||ANOVA|||||||0.478
71088822|NCT01578772|141684084|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0|||<|0.05|TWO_SIDED|95.0|-0.1|0.1|||Wilcoxon (Mann-Whitney)|Pairwise comparisons were performed using Wilcoxon signed rank test. All statistical tests are two-sided with nominal alpha level of 0.05.||||0.1|-0.1|<0.05
71088823|NCT01578772|141684085|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.7|||<|0.05|TWO_SIDED|95.0|-1.3|1.9|||Wilcoxon (Mann-Whitney)|Pairwise comparisons were performed using Wilcoxon signed rank test. All statistical tests are two-sided with nominal alpha level of 0.05.||||1.9|-1.3|<0.05
71088824|NCT00808340|141684136|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.5.|Mean Difference (Final Values)|-0.1249|STANDARD_ERROR_OF_MEAN|0.1464|||TWO_SIDED|97.5|-0.4143|0.1644|||Mixed Models Analysis||Mean difference is calculated as senofilcon A multifocal prod minus senofilcon A multifocal test.|Alternative hypothesis is that senofilcon A multifocal prod is non-inferior to senofilcon A multifocal test.||0.1644|-0.4143|
71088825|NCT00808340|141684136|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.5|Mean Difference (Final Values)|-0.3693|STANDARD_ERROR_OF_MEAN|0.1464|||TWO_SIDED|97.5|-0.6587|-0.07996|||Mixed Models Analysis||The mean difference was calculated as balafilcon A multifocal minus senofilcon A multifocal prod.|Alternative hypothesis is that senofilcon A multifocal prod is non-inferior to balafilcon A multifocal.||-0.07996|-0.6587|
71088826|NCT00808340|141684137|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.5|Mean Difference (Final Values)|-0.04083|STANDARD_ERROR_OF_MEAN|0.1464|||TWO_SIDED|97.5|-0.2485|0.3302|||Mixed Models Analysis||The mean difference is calculated as senofilcon A multifocal prod minus senofilcon A multifocal test.|Alternative hypothesis is that senofilcon A multifocal prod is non-inferior to senofilcon A multifocal test.||0.3302|-0.2485|
71088827|NCT00808340|141684137|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.5|Mean Difference (Final Values)|-0.4608|STANDARD_ERROR_OF_MEAN|0.1464|||TWO_SIDED|97.5|-0.7502|-0.1714|||Mixed Models Analysis||The mean difference was calculated as senofilcon A multifocal prod minus balafilcon A multifocal.|Alternative hypothesis is that senofilcon A multifocal prod is non-inferior to balafilcon A multifocal.||-0.1714|-0.7502|
71088828|NCT00808340|141684138|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.5|Mean Difference (Final Values)|-0.02941|STANDARD_ERROR_OF_MEAN|0.02656|||TWO_SIDED|97.5|-0.08153|0.02271|||Mixed Models Analysis||The mean difference is calculated as senofilcon A multifocal prod minus senofilcon A multifocal test.|Alternative hypothesis is senofilcon A multifocal prod is non-inferior to senofilcon A multifocal test.||0.02271|-0.08153|
71088829|NCT00808340|141684138|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.5|Mean Difference (Final Values)|-0.06765|STANDARD_ERROR_OF_MEAN|0.02656|||TWO_SIDED|97.5|-0.1198|-0.01553|||Mixed Models Analysis||The mean difference is calculated as senfilcon A multifocal prod minus balafilcon A multifocal.|Alternative hypothesis is senofilcon A multifocal prod is non-inferior to balafilcon A multifocal.||-0.01553|-0.1198|
71088830|NCT00808340|141684139|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.5|Mean Difference (Final Values)|-0.3304|STANDARD_ERROR_OF_MEAN|0.2243|||TWO_SIDED|97.5|-0.779|0.1183|||Mixed Models Analysis||The mean difference is calculated as senofilcon A multifocal prod minus senofilcon A multifocal test.|Alternative hyposthesis is that senofilcon A multifocal prod is non-inferior to senofilcon A multifocal test.||0.1183|-0.779|
71088831|NCT00808340|141684139|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.5|Mean Difference (Final Values)|-0.2281|STANDARD_ERROR_OF_MEAN|0.2243|||TWO_SIDED|97.5|-0.6767|0.2206|||Mixed Models Analysis||The mean difference is calculated as senofilcon A multifocal prod minus balafilcon A multifocal.|Alternativie hypothesis is that senofilcon A multifocal prod is non-inferior to balafilcon A multifocal.||0.2206|-0.6767|
71088832|NCT00843492|141684187|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3|||<|0.001|TWO_SIDED|95.0|0.15|0.54|||Fisher Exact|||||0.54|0.15|<0.001
71088833|NCT02941640|141684230|OTHER|Anova|||||<|0.0001||||||Significant when P\<0.05|ANOVA|||||||<0.0001
71088834|NCT02941640|141684230|OTHER|||||||0.001||||||Significant when P\<0.05.|Tukey post hoc test|||Post hoc analysis was done by Tukey test.||||0.001
71088835|NCT02941640|141684230|OTHER|Tukey post hoc test|||||<|0.0001||||||Significant when P\<0.05|Tukey post hoc test|||||||<0.0001
71088836|NCT02941640|141684230|OTHER|||||||0.044||||||Significant when P\<0.05|Tukey post hoc test|||||||0.044
71088837|NCT02941640|141684230|OTHER||||||<|0.272||||||Significant when P\<0.05.|Tukey post hoc test|||||||<0.272
71088838|NCT02941640|141684230|OTHER|||||||0.835||||||Significant when P\<0.05.|Tukey post hoc test|||||||0.835
71088839|NCT02941640|141684230|OTHER|||||||0.199||||||Significant when P\<0.05.|Tukey post hoc test|||||||0.199
71088840|NCT02941640|141684231|OTHER|Anova|||||<|0.0001||||||Significant when P\<0.05.|ANOVA|||||||<0.0001
71088841|NCT02941640|141684231|OTHER||||||<|0.0001||||||Significant when P\<0.05|Tukey post hoc test|||||||<0.0001
70946303|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at EOT;||||0.3173
70857641|NCT02233946|141201288|SUPERIORITY||Cox Proportional Hazard|0.76|||||TWO_SIDED|95.0|0.44|1.32||||||Participants who reported no past-12-month use of alcohol or other drugs at baseline||1.32|0.44|
71088842|NCT02941640|141684231|OTHER||||||<|0.0001||||||Significant when P\<0.05|Tukey post hoc test|||||||<0.0001
71088843|NCT02941640|141684231|OTHER||||||<|0.0001||||||Significant when P\<0.05.|Tukey post hoc test|||||||<0.0001
71088844|NCT02941640|141684231|OTHER||||||<|0.0001|||||||Tukey post hoc test|||||||<0.0001
71088845|NCT02941640|141684231|OTHER||||||<|0.0001||||||Significant when P\<0.05.|Tukey post hoc test|||||||<0.0001
71088846|NCT02941640|141684231|OTHER|||||||1||||||Significant when P\<0.05|Tukey post hoc test|||||||1.00
71088847|NCT01149655|141684239|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.461||||0.0161|TWO_SIDED|95.0|0.242|0.879|||Log Rank|The log-rank test was based on time to exacerbation of psychotic symptoms/impending relapse.|Hazard ratios and their 95% confidence intervals were derived from the Cox Proportional Hazard model with treatment as term. Hazard ratio \< 1 is in favor of oral aripiprazole 10-30 mg group for superiority test.|The total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||0.879|0.242|0.0161
71088848|NCT01149655|141684241|SUPERIORITY_OR_OTHER|||||||0.0962|TWO_SIDED||||||Chi-squared|p-value was derived using Chi-square test.||Statistical Analysis for Last Visit. The total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0962
71088849|NCT01149655|141684242|SUPERIORITY_OR_OTHER|||||||0.9025|TWO_SIDED||||||Chi-squared|p-value was derived using Chi-square test.||The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.9025
71088850|NCT01149655|141684243|SUPERIORITY_OR_OTHER|||||||0.0076|TWO_SIDED||||||Log Rank|p-value was derived from the log-rank tests.||The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0076
71088851|NCT01149655|141684246|SUPERIORITY_OR_OTHER|||||||0.3862|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis at Baseline. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.3862
71088852|NCT01149655|141684246|SUPERIORITY_OR_OTHER|||||||0.8861|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 1. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.8861
71088853|NCT01149655|141684246|SUPERIORITY_OR_OTHER|||||||0.8189|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 2. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.8189
71088854|NCT01149655|141684246|SUPERIORITY_OR_OTHER|||||||0.3689|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 3. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.3689
71088855|NCT01149655|141684246|SUPERIORITY_OR_OTHER|||||||0.9723|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 4. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.9723
71088856|NCT01149655|141684246|SUPERIORITY_OR_OTHER|||||||0.2985|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 6. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.2985
71088857|NCT01149655|141684246|SUPERIORITY_OR_OTHER|||||||0.0883|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 8. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0883
71088858|NCT01149655|141684246|SUPERIORITY_OR_OTHER|||||||0.0228|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 10. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0228
70857642|NCT02233946|141201289|SUPERIORITY||Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.5|1.34||||||"Participants with riding risk at baseline:~Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 6 months follow-up, cSBI vs. TAU."||1.34|0.50|
70857643|NCT02233946|141201289|SUPERIORITY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.44|1.19||||||"Participants with riding risk at baseline:~Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 9 months follow-up, cSBI vs. TAU."||1.19|0.44|
70857644|NCT02233946|141201289|SUPERIORITY||Risk Ratio (RR)|0.58|||||TWO_SIDED|95.0|0.37|0.91||||||"Participants with riding risk at baseline:~Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 12 months follow-up, cSBI vs. TAU."||0.91|0.37|
70946304|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at EOT;||||0.3173
71126174|NCT03002311|141758422|SUPERIORITY|We conducted a conditional power analysis 120 days after 6 months of enrollment. We determined the effect size based on the difference of proportions of follow-up attendance in the intervention and control arms. We used the effect size of 20% to estimate the sample size needed for a two-sided alpha of 0.05 at 90% power and a 1:1 ratio to require 266 participants. Loss to follow-up was estimated to be 20%, increasing target enrollment to 334 total participants.|||||<|0.001|||||||Gray's test|We compared the cumulative incidence function.||||||<0.001
71126175|NCT03002311|141758423|SUPERIORITY|This was a secondary analysis so no power analysis was done.||||||0.8||||||We used a two-sided alpha of 0.05 to determine significance.|Gray's test|We compared the cumulative incidence functions.||||||0.8
71126176|NCT02868229|141758453|SUPERIORITY||Differences of LS Means|-5.666||||0.002|TWO_SIDED|95.0|-9.082|-2.25|||ANCOVA|||The P-value was obtained from rank transformed analysis of covariance (ANCOVA) model, where the rank transformed change from baseline (CFB) values as the response variable and treatments as a factor and the rank transformed baseline value as its covariate.||-2.250|-9.082|0.002
71126177|NCT02868229|141758453|SUPERIORITY||Differences of LS Means|-6.913|||<|0.001|TWO_SIDED|95.0|-10.613|-3.214|||ANCOVA|||The P-value was obtained from rank transformed analysis of covariance (ANCOVA) model, where the rank transformed change from baseline (CFB) values as the response variable and treatments as a factor and the rank transformed baseline value as its covariate.||-3.214|-10.613|<0.001
71126178|NCT02868229|141758453|SUPERIORITY||Differences of LS Means|-9.591|||<|0.001|TWO_SIDED|95.0|-13.217|-5.965|||ANCOVA|||The P-value was obtained from rank transformed analysis of covariance (ANCOVA) model, where the rank transformed change from baseline (CFB) values as the response variable and treatments as a factor and the rank transformed baseline value as its covariate.||-5.965|-13.217|<0.001
71126179|NCT06225466|141758611|SUPERIORITY||least squares mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.013||0.123|TWO_SIDED|95.0|-0.005|0.047|||ANOVA|||||0.047|-0.005|0.123
71126180|NCT06225466|141758612|SUPERIORITY||Odds Ratio (OR)|0.55||||0.102|TWO_SIDED|95.0|0.26|1.12|||Mixed Models Analysis|||||1.12|0.26|0.102
71126181|NCT06225466|141758613|SUPERIORITY||Incidence rate ratio|2.37||||0.008|TWO_SIDED|95.0|1.25|4.52|||Negative Binomial Regression|||||4.52|1.25|0.008
71126182|NCT00997620|141758772|OTHER||Mean Difference (Net)|0.5|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||The statistical analysis was of t testing of the difference of the mean between the baseline and after two weeks. The power analysis was prior to data collection was not performed for this test. The null hypothesis is no different, no difference between placebo and active treatment.||||< .05
71126183|NCT00300365|141758793|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71126184|NCT01818492|141758800|SUPERIORITY|||||||0.0134|||||||Exact binomial test|This test was undertaken at the one-sided 0.025 significance level.||Pre-specified null hypothesis that ORR is at most 40%.||||0.0134
71126185|NCT01818492|141758801|SUPERIORITY|||||||0.0031|||||||Exact binomial test|This test was undertaken at the one-sided 0.025 significance level.||Pre-specified null hypothesis that ORR is at most 40%||||0.0031
71126186|NCT01818492|141758802|SUPERIORITY|||||||0.0205|||||||Exact binomial test|This test was undertaken at the one-sided 0.025 significance level.||Pre-specified null hypothesis that ORR is at most 40%||||0.0205
71126187|NCT01818492|141758803|SUPERIORITY|||||||0.0053|||||||Exact binomial test|This test was undertaken at the one-sided 0.025 significance level.||Pre-specified null hypothesis that ORR is at most 40%.||||0.0053
71126188|NCT02986854|141758857|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|30.95|||||TWO_SIDED|95.0|21.76|41.25|||Miettinen & Nurminen score method|||Serogroup A-day 29-Total seroresponse (Menveo-Menveo vs. Naive)||41.25|21.76|
71126189|NCT02986854|141758857|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|30.86|||||TWO_SIDED|95.0|21.66|41.17|||Miettinen & Nurminen score method|||Serogroup A-day 29-Total seroresponse (Menactra-Menveo vs. Naive)||41.17|21.66|
71126190|NCT02986854|141758857|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|30.91|||||TWO_SIDED|95.0|21.89|41.12|||Miettinen & Nurminen score method|||Serogroup A-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||41.12|21.89|
71126191|NCT02986854|141758857|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method.|Difference in percentages|0.09|||||TWO_SIDED|95.0|-3.15|3.36|||Miettinen & Nurminen score method|||Serogroup A- DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)||3.36|-3.15|
71126192|NCT02986854|141758857|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|38.5|||||TWO_SIDED|95.0|28.54|48.9|||Miettinen & Nurminen score method|||Serogroup C-day 29-Total seroresponse (Menveo-Menveo vs. Naive)||48.90|28.54|
71126193|NCT02986854|141758857|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|39.08|||||TWO_SIDED|95.0|29.16|49.46|||Miettinen & Nurminen score method|||Serogroup C-day 29-Total seroresponse (Menactra-Menveo vs. Naive)||49.46|29.16|
71088859|NCT01149655|141684246|SUPERIORITY_OR_OTHER|||||||0.0274|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 12. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0274
71088860|NCT01149655|141684246|SUPERIORITY_OR_OTHER|||||||0.0135|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 14. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0135
71088861|NCT01149655|141684246|SUPERIORITY_OR_OTHER|||||||0.0059|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 16. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0059
70857645|NCT02233946|141201289|SUPERIORITY||Risk Ratio (RR)|0.72|||||TWO_SIDED|95.0|0.43|1.23||||||"Participants with no riding risk at baseline:~Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 6 months follow-up, cSBI vs. TAU."||1.23|0.43|
70946305|NCT00551135|141392980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4386|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at EOT;||||0.4386
71088862|NCT01149655|141684246|SUPERIORITY_OR_OTHER|||||||0.0076|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 18. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0076
71126194|NCT02986854|141758857|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|38.79|||||TWO_SIDED|95.0|29.03|49.06|||Miettinen & Nurminen score method|||Serogroup C-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||49.06|29.03|
71126195|NCT02986854|141758857|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|-0.59|||||TWO_SIDED|95.0|-4.12|2.92|||Miettinen & Nurminen score method|||Serogroup C-DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)||2.92|-4.12|
70946306|NCT00551135|141392981|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1723|TWO_SIDED|||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||24 h PS.||||0.1723
71126196|NCT02986854|141758857|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|59.98|||||TWO_SIDED|95.0|49.49|69.32|||Miettinen & Nurminen score method|||Serogroup W-day 29-Total seroresponse (Menveo-Menveo vs. Naive)||69.32|49.49|
71126197|NCT02986854|141758857|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|57.37|||||TWO_SIDED|95.0|46.71|66.88|||Miettinen & Nurminen score method|||Serogroup W-day 29-Total seroresponse (Menactra-Menveo vs. Naive)||66.88|46.71|
71126198|NCT02986854|141758857|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|58.69|||||TWO_SIDED|95.0|48.32|67.94|||Miettinen & Nurminen score method|||Serogroup W-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||67.94|48.32|
71126199|NCT02986854|141758857|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|2.61|||||TWO_SIDED|95.0|-1.17|6.62|||Miettinen & Nurminen score method|||Serogroup W-DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)||6.62|-1.17|
71126200|NCT02986854|141758857|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|45.25|||||TWO_SIDED|95.0|35.11|55.47|||Miettinen & Nurminen score method|||Serogroup Y-day 29-Total seroresponse (Menveo-Menveo vs. Naive)||55.47|35.11|
71126201|NCT02986854|141758857|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|42.67|||||TWO_SIDED|95.0|32.34|53.04|||Miettinen & Nurminen score method|||Serogroup Y-day 29-Total seroresponse (Menactra-Menveo vs. Naive)||53.04|32.34|
71126202|NCT02986854|141758857|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|43.98|||||TWO_SIDED|95.0|33.92|54.14|||Miettinen & Nurminen score method|||Serogroup Y-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||54.14|33.92|
71126203|NCT02986854|141758857|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|2.58|||||TWO_SIDED|95.0|-0.86|6.3|||Miettinen & Nurminen score method|||Serogroup Y- DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)||6.3|-0.86|
71126204|NCT02986854|141758863|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|8.16|||||TWO_SIDED|95.0|1.23|13.41|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||13.41|1.23|
70857646|NCT02233946|141201289|SUPERIORITY||Risk Ratio (RR)|1.33|||||TWO_SIDED|95.0|0.67|2.66||||||"Participants with no riding risk at baseline:~Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 9 months follow-up, cSBI vs. TAU."||2.66|0.67|
71088863|NCT01149655|141684246|SUPERIORITY_OR_OTHER|||||||0.0065|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 20. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0065
70946307|NCT00551135|141392981|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0639|TWO_SIDED|||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||24 h PS||||0.0639
71126205|NCT02986854|141758863|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method.|Between group differences in percentage|10.59|||||TWO_SIDED|95.0|3.54|16.14|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||16.14|3.54|
71126206|NCT02986854|141758863|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method.|Between group differences in percentage|9.36|||||TWO_SIDED|95.0|2.72|13.58|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menactra-Menveo vs. Naive)||13.58|2.72|
71126207|NCT02986854|141758863|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method.|Between group differences in percentage|-2.44|||||TWO_SIDED|95.0|-8.17|3.24|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||3.24|-8.17|
71126208|NCT02986854|141758863|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|6.94|||||TWO_SIDED|95.0|-3.57|14.15|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||14.15|-3.57|
71126209|NCT02986854|141758863|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|8.88|||||TWO_SIDED|95.0|-1.77|16.52|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||16.52|-1.77|
71126210|NCT02986854|141758863|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|7.89|||||TWO_SIDED|95.0|-2.34|13.48|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||13.48|-2.34|
71126211|NCT02986854|141758863|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-1.93|||||TWO_SIDED|95.0|-9.84|5.82|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||5.82|-9.84|
71126212|NCT02986854|141758863|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|44.33|||||TWO_SIDED|95.0|30.25|54.6|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||54.60|30.25|
71126213|NCT02986854|141758863|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|38.05|||||TWO_SIDED|95.0|23.93|48.58|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||48.58|23.93|
71126214|NCT02986854|141758863|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|41.26|||||TWO_SIDED|95.0|28.15|49.72|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||49.72|28.15|
71126215|NCT02986854|141758863|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|6.28|||||TWO_SIDED|95.0|-5.31|17.71|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||17.71|-5.31|
71126216|NCT02986854|141758863|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|27.65|||||TWO_SIDED|95.0|19.25|37.65|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||37.65|19.25|
71126217|NCT02986854|141758863|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|27.97|||||TWO_SIDED|95.0|19.6|37.95|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||37.95|19.60|
71126218|NCT02986854|141758863|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|27.81|||||TWO_SIDED|95.0|19.5|37.76|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||37.76|19.50|
71126219|NCT02986854|141758863|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-0.32|||||TWO_SIDED|95.0|-2.56|1.86|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||1.86|-2.56|
71126220|NCT02986854|141758864|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|27.78|||||TWO_SIDED|95.0|16.23|38.27|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||38.27|16.23|
71126221|NCT02986854|141758864|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|20.4|||||TWO_SIDED|95.0|8.78|31.03|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||31.03|8.78|
71126222|NCT02986854|141758864|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|24.14|||||TWO_SIDED|95.0|13.28|33.86|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||33.86|13.28|
71126223|NCT02986854|141758864|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|7.37|||||TWO_SIDED|95.0|-0.76|15.42|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||15.42|-0.76|
71126224|NCT02986854|141758864|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|27.08|||||TWO_SIDED|95.0|11.04|42.14|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||42.14|11.04|
71126225|NCT02986854|141758864|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|16.39|||||TWO_SIDED|95.0|0.04|31.9|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||31.90|0.04|
71126226|NCT02986854|141758864|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|21.85|||||TWO_SIDED|95.0|6.73|36.11|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||36.11|6.73|
71126227|NCT02986854|141758864|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|10.69|||||TWO_SIDED|95.0|-0.42|21.6|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||21.60|-0.42|
71126228|NCT02986854|141758864|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|44.4|||||TWO_SIDED|95.0|28.65|58.93|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||58.93|28.65|
71126229|NCT02986854|141758864|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|48.9|||||TWO_SIDED|95.0|33.45|63.13|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||63.13|33.45|
71126230|NCT02986854|141758864|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|46.61|||||TWO_SIDED|95.0|31.52|60.59|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||60.59|31.52|
71126231|NCT02986854|141758864|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-4.5|||||TWO_SIDED|95.0|-11.84|2.69|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||2.69|-11.84|
71126232|NCT02986854|141758864|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|12.9|||||TWO_SIDED|95.0|7.53|21.22|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||21.22|7.53|
71126233|NCT02986854|141758864|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|12.55|||||TWO_SIDED|95.0|7.1|20.89|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||20.89|7.10|
71088864|NCT01149655|141684246|SUPERIORITY_OR_OTHER|||||||0.0175|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 22. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0175
71088865|NCT01149655|141684246|SUPERIORITY_OR_OTHER|||||||0.0107|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 24. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0107
71088866|NCT01149655|141684246|SUPERIORITY_OR_OTHER|||||||0.0118|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 26. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0118
71088867|NCT01149655|141684246|SUPERIORITY_OR_OTHER|||||||0.0232|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 28. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0232
71088868|NCT01149655|141684246|SUPERIORITY_OR_OTHER|||||||0.0337|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 30. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0337
71126234|NCT02986854|141758864|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|12.73|||||TWO_SIDED|95.0|7.34|21.05|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||21.05|7.34|
71126235|NCT02986854|141758864|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.36|||||TWO_SIDED|95.0|-0.96|1.99|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||1.99|-0.96|
71126236|NCT02986854|141758865|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|14.14|||||TWO_SIDED|95.0|3.46|25.39|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||25.39|3.46|
71126237|NCT02986854|141758865|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|15.66|||||TWO_SIDED|95.0|5.0|26.89|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||26.89|5.00|
71126238|NCT02986854|141758865|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|14.89|||||TWO_SIDED|95.0|4.91|25.62|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||25.62|4.91|
70946308|NCT00551135|141392981|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0021|TWO_SIDED|||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||24 h PS.||||0.0021
71126239|NCT02986854|141758865|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-1.52|||||TWO_SIDED|95.0|-8.51|5.5|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||5.50|-8.51|
71126240|NCT02986854|141758865|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|19.44|||||TWO_SIDED|95.0|5.25|34.83|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||34.83|5.25|
71126241|NCT02986854|141758865|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|20.11|||||TWO_SIDED|95.0|5.88|35.5|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||35.50|5.88|
71088869|NCT01149655|141684246|SUPERIORITY_OR_OTHER|||||||0.0507|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 32. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0507
70946309|NCT00551135|141392981|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1127|TWO_SIDED|||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||EOT.||||0.1127
71088870|NCT01149655|141684246|SUPERIORITY_OR_OTHER|||||||0.0791|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 34. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0791
71088871|NCT01149655|141684246|SUPERIORITY_OR_OTHER|||||||0.0898|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 36. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0898
71088872|NCT01149655|141684246|SUPERIORITY_OR_OTHER|||||||0.0686|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 38. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0686
71088873|NCT01149655|141684246|SUPERIORITY_OR_OTHER|||||||0.0833|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 40. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0833
71088874|NCT01149655|141684246|SUPERIORITY_OR_OTHER|||||||0.0824|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 42. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0824
71088875|NCT01149655|141684246|SUPERIORITY_OR_OTHER|||||||0.0686|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 44. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0686
70946310|NCT00551135|141392981|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0703|TWO_SIDED|||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||EOT.||||0.0703
70946311|NCT00551135|141392981|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012|TWO_SIDED|||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||EOT.||||0.0012
71088876|NCT01149655|141684246|SUPERIORITY_OR_OTHER|||||||0.0737|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 46. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0737
71088877|NCT01149655|141684246|SUPERIORITY_OR_OTHER|||||||0.0893|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 48. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0893
71126242|NCT02986854|141758865|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|19.77|||||TWO_SIDED|95.0|6.53|34.58|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||34.58|6.53|
71126243|NCT02986854|141758865|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-0.66|||||TWO_SIDED|95.0|-9.67|8.4|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||8.40|-9.67|
70946312|NCT00551135|141392983|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1927|TWO_SIDED|||||P-values derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjests have been combined into pooled centers.|Cochran-Mantel-Haenszel|||24 h PS.||||0.1927
71088878|NCT01149655|141684246|SUPERIORITY_OR_OTHER|||||||0.0706|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 50. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0706
71088879|NCT01149655|141684246|SUPERIORITY_OR_OTHER|||||||0.0657|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 52. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0657
71088880|NCT04030598|141684250|SUPERIORITY||Percentage Difference|-90.0||||0.001|TWO_SIDED|95.0|-96.0|-76.0|||Wald Chi-Square||The percentage difference in mean investigator-confirmed HAE attack rate between donidalorsen 80 mg and placebo was calculated as 100 percentage (%) × (mean rate ratio -1).|||-76.00|-96.00|0.001
71088881|NCT04030598|141684251|SUPERIORITY||Percentage Difference|-89.0||||0.003|TWO_SIDED|95.0|-95.0|-77.0|||Wald Chi-Square||The percentage difference in mean investigator-confirmed HAE attack rate between donidalorsen 80 mg and placebo was calculated as 100% × (mean rate ratio -1).|||-77.00|-95.00|0.003
71088882|NCT04030598|141684252|SUPERIORITY||Percentage Difference|-96.0||||0.004|TWO_SIDED|95.0|-100.0|-65.0|||Wald Chi-Square||The percentage difference in mean investigator-confirmed HAE attack rate between donidalorsen 80 mg and placebo was calculated as 100% × (mean rate ratio -1).|||-65.00|-100.00|0.004
71088883|NCT04030598|141684253|SUPERIORITY||Risk Difference (RD)|66.7||||0.004|TWO_SIDED|95.0|17.5|95.7|||Fisher Exact|||For ≥ 50% reduction from Baseline in the HAE attack rate.||95.7|17.5|0.004
71088884|NCT04030598|141684253|SUPERIORITY||Risk Difference (RD)|75.6||||0.003|TWO_SIDED|95.0|26.8|96.5|||Fisher Exact|||For ≥ 70% reduction from Baseline in the HAE attack rate.||96.5|26.8|0.003
71088885|NCT04030598|141684253|SUPERIORITY||Risk Difference (RD)|92.3|||<|0.001|TWO_SIDED|95.0|48.0|99.8|||Fisher Exact|||For ≥ 90% reduction from Baseline in the HAE attack rate.||99.8|48.0|<0.001
71088886|NCT04030598|141684254|SUPERIORITY||Percentage Difference|-95.0||||0.009|TWO_SIDED|95.0|-99.0|-52.0|||Wald Chi-Square|||||-52.00|-99.00|0.009
71088887|NCT04030598|141684257|SUPERIORITY||Risk Difference (RD)|-14.3||||1|TWO_SIDED|95.0|-59.1|33.9|||Fisher Exact|||Week 9||33.9|-59.1|1.000
71126244|NCT02986854|141758865|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|30.2|||||TWO_SIDED|95.0|16.78|45.45|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||45.45|16.78|
71126245|NCT02986854|141758865|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|34.22|||||TWO_SIDED|95.0|21.29|49.2|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||49.20|21.29|
71126246|NCT02986854|141758865|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|32.17|||||TWO_SIDED|95.0|19.3|47.13|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||47.13|19.30|
71088888|NCT04030598|141684257|SUPERIORITY||Risk Difference (RD)|-21.4||||0.521|TWO_SIDED|95.0|-64.9|27.1|||Fisher Exact|||Week 17||27.1|-64.9|0.521
71088889|NCT04030598|141684258|SUPERIORITY||Treatment Difference|-25.92|||||TWO_SIDED|95.0|-37.1|-14.74||||||Week 9||-14.74|-37.10|
71088890|NCT04030598|141684258|SUPERIORITY||Treatment Difference|-20.69|||||TWO_SIDED|95.0|-32.7|-8.68||||||Week 17||-8.68|-32.70|
71088891|NCT05079321|141684259|OTHER|||||||0.25|||||||t-test, 2 sided|||||||0.25
71088892|NCT05079321|141684260|OTHER|||||||0.36|||||||t-test, 2 sided|||||||0.36
71088893|NCT05079321|141684261|OTHER|||||||1|||||||t-test, 2 sided|||||||1.0
71088894|NCT05079321|141684262|OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.06
71088895|NCT05079321|141684263|OTHER|||||||0.49|||||||t-test, 2 sided|||||||0.49
71088896|NCT05079321|141684264|OTHER|||||||0.07|||||||t-test, 2 sided|||||||0.07
71088897|NCT05079321|141684265|OTHER|||||||0.33|||||||t-test, 2 sided|||||||0.33
71088898|NCT05079321|141684266|OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.65
71088899|NCT05079321|141684268|OTHER|||||||0.91|||||||t-test, 2 sided|||||||0.91
71088900|NCT05079321|141684269|OTHER|||||||0.71|||||||t-test, 2 sided|||||||0.71
71088901|NCT05079321|141684270|OTHER|||||||0.97|||||||t-test, 2 sided|||||||0.97
71088902|NCT05079321|141684271|OTHER|||||||0.75|||||||Fisher Exact|||||||0.75
71088903|NCT05079321|141684272|OTHER|||||||0.59|||||||Fisher Exact|||||||0.59
71088904|NCT05079321|141684273|OTHER|||||||0.69|||||||Fisher Exact|||||||0.69
71088905|NCT02873689|141684291|SUPERIORITY|||||||0.057|||||||Wilcoxon rank-sum test|||||||0.057
71088906|NCT02873689|141684292|SUPERIORITY|||||||0.268|||||||Wilcoxon rank-sum test|||||||0.268
71088907|NCT02997163|141684308|SUPERIORITY||Percent Ratio of Geometric Means|112.2|||||TWO_SIDED|90.0|80.06|157.26||||||||157.26|80.06|
71088908|NCT02997163|141684308|SUPERIORITY||Percent Ratio of Geometric Means|142.98|||||TWO_SIDED|90.0|103.03|198.42||||||||198.42|103.03|
71088909|NCT02997163|141684308|SUPERIORITY||Percent Ratio of Geometric Means|263.32|||||TWO_SIDED|90.0|187.88|369.06||||||||369.06|187.88|
71088910|NCT02997163|141684309|SUPERIORITY||Percent Ratio of Geometric Means|111.13|||||TWO_SIDED|90.0|74.4|166.01||||||||166.01|74.40|
71088911|NCT02997163|141684309|SUPERIORITY||Percent Ratio of Geometric Means|131.57|||||TWO_SIDED|90.0|89.12|194.25||||||||194.25|89.12|
71088912|NCT02997163|141684309|SUPERIORITY||Percent Ratio of Geometric Means|189.32|||||TWO_SIDED|90.0|126.74|282.8||||||||282.80|126.74|
71088913|NCT02997163|141684310|SUPERIORITY||Percent Ratio of Geometric Means|118.58|||||TWO_SIDED|90.0|83.85|167.7||||||||167.70|83.85|
71088914|NCT02997163|141684310|SUPERIORITY||Percent Ratio of Geometric Means|139.34|||||TWO_SIDED|90.0|99.53|195.06||||||||195.06|99.53|
71088915|NCT02997163|141684310|SUPERIORITY||Percent Ratio of Geometric Means|286.61|||||TWO_SIDED|90.0|202.66|405.33||||||||405.33|202.66|
71088916|NCT02997163|141684311|SUPERIORITY||Percent Ratio of Geometric Means|117.45|||||TWO_SIDED|90.0|79.74|172.99||||||||172.99|79.74|
71088917|NCT02997163|141684311|SUPERIORITY||Percent Ratio of Geometric Means|128.22|||||TWO_SIDED|90.0|88.05|186.72||||||||186.72|88.05|
71088918|NCT02997163|141684311|SUPERIORITY||Percent Ratio of Geometric Means|206.07|||||TWO_SIDED|90.0|139.91|303.51||||||||303.51|139.91|
71088919|NCT02470741|141684347|SUPERIORITY||Mean Difference (Net)|-11.85||||0.24|TWO_SIDED|95.0|-32.92|9.23|||Mixed Models Analysis|Repeated measures mixed models, with unstructured co-variance matrix.|Model generated LS Mean Differences|Null hypotheses: Letrozole is not associated with an improvement in the UFSQOL Overall Score.||9.23|-32.92|0.24
71088920|NCT00485836|141684348|SUPERIORITY_OR_OTHER||Difference in Least Squares means|11.5|||<|0.0001||95.0|7.7|15.3||The Hochberg-Bonferroni multiple comparison procedure was used to adjust for comparisons of the two ranibizumab groups with the sham-injection group to maintain an overall type I error rate of 0.05.|ANOVA|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).||||15.3|7.7|<0.0001
71088921|NCT00485836|141684348|SUPERIORITY_OR_OTHER||Difference in Least Squares means|13.8|||<|0.0001||95.0|10.3|17.4||The Hochberg-Bonferroni multiple comparison procedure was used to adjust for comparisons of the two ranibizumab groups with the sham-injection group to maintain an overall type I error rate of 0.05.|ANOVA|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).||||17.4|10.3|<0.0001
70857647|NCT02233946|141201289|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.5|1.99||||||"Participants with no riding risk at baseline:~Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 12 months follow-up, cSBI vs. TAU."||1.99|0.50|
70857648|NCT02054481|141201290|SUPERIORITY_OR_OTHER||Mean Difference (Net)|36.4|||<|0.0001|TWO_SIDED|95.0|19.0|53.8|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|||53.8|19.0|<0.0001
71088922|NCT00485836|141684349|SUPERIORITY_OR_OTHER||Difference in percentage|29.3|||<|0.0001||95.0|18.8|39.7|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||39.7|18.8|<0.0001
71088923|NCT00485836|141684349|SUPERIORITY_OR_OTHER||Difference in percentage|30.3|||<|0.0001||95.0|19.6|40.9|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||40.9|19.6|<0.0001
70946313|NCT00551135|141392983|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3865|TWO_SIDED|||||P-values derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjests have been combined into pooled centers.|Cochran-Mantel-Haenszel|||72 h PS||||0.3865
71088924|NCT00485836|141684350|SUPERIORITY_OR_OTHER||Difference in percentage|11.3||||0.0019||95.0|4.3|18.2|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||18.2|4.3|0.0019
71088925|NCT00485836|141684350|SUPERIORITY_OR_OTHER||Difference in percentage|13.6|||<|0.0001||95.0|7.2|20.1|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||20.1|7.2|<0.0001
71088926|NCT00485836|141684351|SUPERIORITY_OR_OTHER||Difference in percentage|51.9|||<|0.0001||95.0|41.6|62.3|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||62.3|41.6|<0.0001
71088927|NCT00485836|141684351|SUPERIORITY_OR_OTHER||Difference in percentage|54.0|||<|0.0001||95.0|44.0|64.1|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||64.1|44.0|<0.0001
71088928|NCT00485836|141684352|SUPERIORITY_OR_OTHER||Difference in Least Squares means|-272.2|||<|0.0001||95.0|-329.9|-214.5|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline value of central foveal thickness.||||-214.5|-329.9|<0.0001
71088929|NCT00485836|141684352|SUPERIORITY_OR_OTHER||Difference in Least Squares means|-283.8|||<|0.0001||95.0|-337.8|-229.8|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline value of central foveal thickness.||||-229.8|-337.8|<0.0001
71088930|NCT00485836|141684353|SUPERIORITY_OR_OTHER||Difference in Least Squares means|5.8||||0.0019||95.0|2.1|9.4|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Near Activities Subscale score.||||9.4|2.1|0.0019
71088931|NCT00485836|141684353|SUPERIORITY_OR_OTHER||Difference in Least Squares means|4.9||||0.0099||95.0|1.2|8.6|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Near Activities Subscale score.||||8.6|1.2|0.0099
71088932|NCT00485836|141684354|SUPERIORITY_OR_OTHER||Difference in Least Squares means|6.3||||0.0002||95.0|3.1|9.5|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Distance Activities Subscale score.||||9.5|3.1|0.0002
71088933|NCT00485836|141684354|SUPERIORITY_OR_OTHER||Difference in Least Squares means|4.1||||0.0199||95.0|0.7|7.6|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Distance Activities Subscale score.||||7.6|0.7|0.0199
71088934|NCT01677286|141684370|OTHER|P-values and confidence intervals are not adjusted for multiple testing|Mean outcome change|171.0||||0.035|TWO_SIDED|95.0|14.1|328.0|||Mixed Models Analysis|degrees of freedom = 12||BNP pg/mL, baseline versus end study values||328|14.1|0.035
70946314|NCT00551135|141392983|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9869|TWO_SIDED|||||P-values derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjests have been combined into pooled centers.|Cochran-Mantel-Haenszel|||72 h PS.||||0.9869
70946315|NCT00551135|141392983|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4354|TWO_SIDED|||||P-values derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjests have been combined into pooled centers.|Cochran-Mantel-Haenszel|||72 h PS.||||0.4354
70946316|NCT00551135|141392983|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8061|TWO_SIDED|||||P-values derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjests have been combined into pooled centers.|Cochran-Mantel-Haenszel|||72 h PS.||||0.8061
71088935|NCT01677286|141684371|OTHER|P-values and confidence intervals are not adjusted for multiple testing|Mean outcome change|0.0072||||0.34|TWO_SIDED|95.0|-0.009|0.0234|||Mixed Models Analysis|degrees of freedom = 12||Troponin I ng/mL, baseline versus end study levels.||0.0234|-0.009|0.340
71088936|NCT01677286|141684372|OTHER|P-values and confidence intervals are not adjusted for multiple testing|Change in outcome measure|-7.39||||0.017|TWO_SIDED|95.0|-13.12|-1.67|||Mixed Models Analysis|degrees of freedom = 10||Creatinine clearance, baseline versus end study levels.||-1.67|-13.12|0.017
71088937|NCT01677286|141684373|OTHER|P-values and confidence intervals are not adjusted for multiple testing|Change in outcome measure|0.091||||0.603|TWO_SIDED|95.0|-0.285|0.466|||Mixed Models Analysis|degrees of freedom = 10||Proteinuria (g/24 hours), baseline versus end study levels.||0.466|-0.285|0.603
71088938|NCT01258374|141684374|OTHER||||||<|0.01||||||The PK paramaters reported as geometric means, were calculated using noncompartmental modelinf techniques (WinNolin; Pharsight Corporation, Mountain View, CA)|Noncompartmental modeling techniques||||The pharmacokinetic parameters calculated for DRV, RTV and RAL were trough plasma concentration (C trough), defined as the concentration at 24 or 12 h after observed dose, the maximum observed plasma concentration (C max), the area under the plasma concentration-time curve from 0 to 24 H (AUC 0-24) or 0 to 12 h (AUC 0-12) and the elimination half-life (t1/2). AUC and t1/2 were calculated using non using noncompartmental modeling techniques (WinNolin; Pharsight Corporation, Mountain View, CA). All of these PK parameters are reported as geometric means.|||<0.01
71088939|NCT00368251|141684385|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|0.15|||=|0.942|TWO_SIDED|95.0|-26.12|24.96||All hypotheses are tested at the 5 % level. The multiplicity scheme (hierarchical testing procedure) assures strong control of the type I error at the 5 % level.|stratified Wilcoxon Test|Estimates and confidence intervals from Hodges-Lehmann (unstratified).|Difference versus Placebo was calculated.|"The first hypothesis for the primary efficacy variable compares placebo versus Brivaracetam (BRV) 150 mg/day.~The second hypothesis for the primary efficacy variable compares placebo versus BRV 5 mg/day. However, this second hypothesis will only be tested when all the hypotheses for placebo versus BRV 150 mg/day are significant for the primary three UMRS related secondary endpoints.~The hypotheses will be tested using nonparametric analysis. The study was designed to have 80 % power."||24.96|-26.12|=0.942
71088940|NCT00368251|141684385|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|-18.05|||=|0.105|TWO_SIDED|95.0|-39.31|4.86||Tested at the 5 % level - given the primary endpoint and the three UMRS related secondary endpoints comparing placebo versus Brivaracetam (BRV) 150 mg/day are significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intervals from Hodges-Lehmann (unstratified).|Difference versus Placebo.|||4.86|-39.31|=0.105
71088941|NCT00368251|141684386|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|1.24|||=|0.672|TWO_SIDED|95.0|-21.9|31.06||Tested at the 5 % level - given the Primary Outcome testing Placebo versus BRV 150 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intervals are obtained from Hodges-Lehmann(unstratified).|Difference versus Placebo.|If primary efficacy is proven for Brivaracetam (BRV) 150 mg/day, the following secondary endpoints will be tested for Placebo versus BRV 150 mg/day. The testing scheme will be hierarchical, thus statistical significance at 5 % on BRV 150 mg/day on a secondary endpoint is needed to continue testing BRV 150 mg/day at 5 % significance level for the next secondary endpoint.||31.06|-21.90|=0.672
71088942|NCT00368251|141684386|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|0.0|||=|0.806|TWO_SIDED|95.0|-33.33|18.75||Tested at the 5 % level - given the primary endpoint testing Placebo versus Brivaracetam (BRV) 5 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intevals are obtained from Hodges-Lehmann (unstratified).|Difference versus Placebo.|"In case the three endpoints are significant for placebo versus Brivaracetam (BRV) 150 mg/day, the primary endpoint will be tested for Placebo versus BRV 5 mg/day. In case of significance, the three UMRS related secondary endpoints will be tested for Placebo versus BRV 5 mg/day, provided the previous is significant at 5 %. Secondary endpoints are tested in the following order:~* Functional Disability~* Stimulus Sensitivity~* Myoclonus Patient Questionnaire"||18.75|-33.33|=0.806
70946317|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1682|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1682
70946318|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2821|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2821
70946319|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4781|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4781
71088943|NCT00368251|141684387|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|0.0|||=|0.549|TWO_SIDED|95.0|-25.0|100.0||Tested at the 5 % level - given the Functional Disability Score comparing Placebo versus Brivaracetam (BRV) 150 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Willcoxon Test|Estimates and confidence intervals are obtained from Hodges-Lehmann (unstratified).|Difference versus Placebo.|||100.00|-25.00|=0.549
71088944|NCT00368251|141684387|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|0.0|||=|0.654|TWO_SIDED|95.0|-50.0|66.67||Tested at the 5 % level - given the Functional Disability Score comparing Placebo versus Brivaracetam (BRV) 5 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intervals are obtained from Hodges-Lehmann (unstratified).|Difference versus Placebo.|||66.67|-50.00|=0.654
71088945|NCT00368251|141684388|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|14.29|||=|0.037|TWO_SIDED|95.0|-1.76|39.39||Tested at the 5 % level - given the Functional Disability Score comparing Placebo versus Brivaracetam (BRV) 150 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intervals are obtained from Hodges-Lehmann (unstratified).|Difference versus Placebo.|||39.39|-1.76|=0.037
71088946|NCT00368251|141684388|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|10.0|||=|0.111|TWO_SIDED|95.0|-5.56|30.0||Tested at the 5 % level - given the Functional Disability Score comparing Placebo versus Brivaracetam (BRV) 5 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intervals are obtained from Hodges-Lehmann (unstratified).|Difference versus Placebo.|||30.00|-5.56|=0.111
70946320|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0557|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0557
71088947|NCT00368251|141684389|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.931||||||The Global Evaluation Scale by Investigator (I-GES) was compared between placebo and each dose at 5 % significance level independently from the previous secondary endpoints.|Stratified Wilcoxon test|||||||=0.931
71088948|NCT00368251|141684389|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.253||||||The Global Evaluation Scale by Investigator (I-GES) was compared between placebo and each dose at 5 % significance level independently from the previous secondary endpoints.|Stratified Wilcoxon test|||P-value for pairwise comparison of each Brivaracetam dose versus Placebo.||||=0.253
71088949|NCT00607893|141684394|OTHER||Mean Difference (Final Values)|0.071||||0.38|TWO_SIDED|95.0|-0.09|0.23|||Regression, Linear||F2-isoprostanes/Cr was log-transformed before analysis. The estimation parameter shows the log-transformed mean difference of the absolute change between groups, while the least square means of two groups are transformed back for presentation.|||0.23|-0.090|0.38
71088950|NCT00607893|141684395|OTHER||Mean Difference (Final Values)|1.83||||0.85|TWO_SIDED|95.0|-17.42|21.07|||Regression, Linear|||||21.07|-17.42|0.85
71126247|NCT02986854|141758865|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-4.02|||||TWO_SIDED|95.0|-9.45|0.74|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||0.74|-9.45|
71126248|NCT02986854|141758865|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|15.22|||||TWO_SIDED|95.0|9.28|23.95|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||23.95|9.28|
71126249|NCT02986854|141758865|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|15.22|||||TWO_SIDED|95.0|9.28|23.95|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||23.95|9.28|
71126250|NCT02986854|141758865|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|15.22|||||TWO_SIDED|95.0|9.28|23.94|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||23.94|9.28|
71088951|NCT00607893|141684396|OTHER||Mean Difference (Final Values)|0.14||||0.92|TWO_SIDED|95.0|-2.6|2.87|||Regression, Linear|||||2.87|-2.60|0.92
71088952|NCT00607893|141684397|OTHER||Mean Difference (Final Values)|0.21||||0.55|TWO_SIDED|95.0|-0.48|0.91|||Regression, Linear|||||0.91|-0.48|0.55
71088953|NCT00607893|141684398|OTHER||Mean Difference (Final Values)|0.38||||0.17|TWO_SIDED|95.0|-0.16|0.92|||Regression, Linear|||||0.92|-0.16|0.17
71088954|NCT00607893|141684399|OTHER||Mean Difference (Final Values)|2.4||||0.076|TWO_SIDED|95.0|-0.26|5.07|||Regression, Linear|||||5.07|-0.26|0.076
71088955|NCT00607893|141684400|OTHER||Mean Difference (Final Values)|0.062||||0.019|TWO_SIDED|95.0|0.01|0.11|||Regression, Linear||sIL-6R was log-transformed before analysis. The estimation parameter shows the log-transformed mean difference of the absolute change between groups, while the least square means of two groups are transformed back for presentation.|||0.11|0.010|0.019
71088956|NCT00607893|141684401|OTHER||Mean Difference (Final Values)|0.17||||0.68|TWO_SIDED|95.0|-0.64|0.99|||Regression, Linear|||||0.99|-0.64|0.68
71126251|NCT02986854|141758865|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.0|||||TWO_SIDED|95.0|-1.31|1.35|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||1.35|-1.31|
71088957|NCT00607893|141684402|OTHER||Mean Difference (Final Values)|1.35||||0.59|TWO_SIDED|95.0|-3.6|6.31|||Regression, Linear|||||6.31|-3.60|0.59
71088958|NCT00607893|141684403|OTHER||Mean Difference (Final Values)|6.93|||<|0.001|TWO_SIDED|95.0|3.04|10.81|||Regression, Linear|||||10.81|3.04|<0.001
71088959|NCT02669849|141684404|SUPERIORITY||Least Squares (LS) Mean Difference|-0.69||||0.7519|TWO_SIDED|95.0|-5.08|3.69|||Mixed-effects model for repeated measure|||||3.69|-5.08|0.7519
71088960|NCT02543840|141684413|SUPERIORITY||Mean Difference (Final Values)|0.2|||<|0.01|TWO_SIDED|95.0|-1.26|1.5||Adjusted for multiple comparisons (Bonferroni four comparisons).|Mixed Models Analysis|||||1.5|-1.26|<0.01
71088961|NCT02543840|141684413|SUPERIORITY||Mean Difference (Final Values)|5.03|||<|0.001|TWO_SIDED|95.0|2.24|7.82||Adjusted for comparisons (Bonferroni for 4 comparisons.)|Regression, Linear|||Among Veteran participants,we used a linear contrast comparing a) those with complex clinical presentations, defined as receiving treatment for three or more mental health diagnoses in the prior year to b) those with two or fewer diagnoses during the facilitation year from T0 to T12..||7.82|2.24|<0.001
71088962|NCT02543840|141684414|SUPERIORITY||Mean Difference (Final Values)|1.2|||<|0.04|TWO_SIDED|95.0|0.04|2.3||Adjusted for comparison (Bonferroni for four comparisons.)|Mixed Models Analysis|||||2.3|0.04|<0.04
71088963|NCT02543840|141684415|SUPERIORITY||Mean Difference (Final Values)|0.6|||>|0.05|TWO_SIDED|95.0|-0.2|0.9|||Mixed Models Analysis|||||0.9|-0.2|>0.05
71088964|NCT02543840|141684416|SUPERIORITY||Mean Difference (Final Values)|0.5|||>|0.05|TWO_SIDED|95.0|-1.3|2.3|||Mixed Models Analysis|||||2.3|-1.3|>0.05
71088965|NCT02543840|141684417|SUPERIORITY||Mean Difference (Final Values)|0.0|||>|0.05|TWO_SIDED|95.0|-0.6|0.8|||Mixed Models Analysis|||||0.8|-0.6|>0.05
71088966|NCT02543840|141684418|SUPERIORITY||Mean Difference (Final Values)|0.005|||>|0.05|TWO_SIDED|95.0|-0.074|0.084|||t-test, 2 sided|Paired.||||0.084|-0.074|>0.05
71088967|NCT02543840|141684419|SUPERIORITY||Mean Difference (Final Values)|0.011|STANDARD_DEVIATION|0.206|>|0.05|TWO_SIDED|95.0|-0.056|0.077|||t-test, 2 sided|Paired.||||0.077|-0.056|>0.05
71126252|NCT02986854|141758866|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|21.75|||||TWO_SIDED|95.0|10.19|32.25|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||32.25|10.19|
71126253|NCT02986854|141758866|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|14.72|||||TWO_SIDED|95.0|3.15|25.29|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||25.29|3.15|
71126254|NCT02986854|141758866|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|18.27|||||TWO_SIDED|95.0|7.44|27.92|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||27.92|7.44|
71126255|NCT02986854|141758866|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|7.03|||||TWO_SIDED|95.0|-1.2|15.17|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||15.17|-1.20|
71126256|NCT02986854|141758866|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|21.91|||||TWO_SIDED|95.0|5.57|36.37|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||36.37|5.57|
71088968|NCT02543840|141684420|SUPERIORITY||Mean Difference (Final Values)|0.153|||<|0.001|TWO_SIDED|95.0|0.044|0.262|||t-test, 2 sided|Paired||||0.262|0.044|<0.001
71088969|NCT02543840|141684421|SUPERIORITY||Mean Difference (Final Values)|0.186|||<|0.01|TWO_SIDED|95.0|0.083|0.289|||t-test, 2 sided|Paired.||||0.289|0.083|<0.01
71088970|NCT02543840|141684422|SUPERIORITY||Mean Difference (Final Values)|-0.12|||<|0.001|TWO_SIDED|95.0|-0.16|-0.07||Repeated patient binary outcome models for hospitalized (0/1) across 8 quarters.|Mixed Models Analysis|Adjusted (Bonferroni four comparisons).||||-0.07|-0.16|<0.001
71088971|NCT04745351|141684423|SUPERIORITY||Hazard Ratio (HR)|0.816||||0.6132|TWO_SIDED|95.0|0.504|1.321||P-value was calculated from stratified log-rank test, stratified by the baseline stratification factors.|Log Rank|||||1.321|0.504|0.6132
71126257|NCT02986854|141758866|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|22.46|||||TWO_SIDED|95.0|6.05|37.0|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||37.00|6.05|
71088972|NCT04745351|141684424|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.3881|TWO_SIDED|95.0|0.497|1.388||P-value was calculated from stratified log-rank test stratified by the baseline stratification factors.|Log Rank|||||1.388|0.497|0.3881
71088973|NCT04745351|141684425|SUPERIORITY||Hazard Ratio (HR)|1.043||||0.9116|TWO_SIDED|95.0|0.493|2.207||The treatment effect p-value was calculated using Cox model with death as the competing risk and baseline stratification factors as covariates.|Regression, Cox|||||2.207|0.493|0.9116
71088974|NCT04745351|141684428|SUPERIORITY|||||||0.8541||||||P-value was analysed from proportional odds model including treatment as the independent variable.|Proportional odds model|||||||0.8541
71088975|NCT04745351|141684429|SUPERIORITY|||||||0.4974||||||P-value was analysed from proportional odds model including treatment as the independent variable.|Proportional odds model|||||||0.4974
71088976|NCT04745351|141684430|SUPERIORITY|||||||0.4283||||||P-value was calculated based on Wilcoxon rank sum test.|Wilcoxon (Mann-Whitney)|||||||0.4283
71088977|NCT04745351|141684431|SUPERIORITY||Relative risk|0.89||||0.2773|TWO_SIDED|95.0|0.731|1.091||The treatment effect p-value was calculated using Cochran-Mantel-Haenszel (CMH) analysis including baseline stratification factors.|Cochran-Mantel-Haenszel|||||1.091|0.731|0.2773
71088978|NCT04745351|141684432|SUPERIORITY||Relative risk|0.97||||0.7538|TWO_SIDED|95.0|0.819|1.155||The treatment effect p-value was calculated using CMH analysis including baseline stratification factors.|Cochran-Mantel-Haenszel|||||1.155|0.819|0.7538
71088979|NCT01248416|141684435|SUPERIORITY||||||<|0.006|||||||ANCOVA|||||||<0.006
71088980|NCT01248416|141684437|SUPERIORITY|||||||0.906|||||||ANOVA|||||||0.906
71088981|NCT01248416|141684438|SUPERIORITY|||||||0.015|||||||ANOVA|||||||0.015
71088982|NCT01248416|141684440|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71088983|NCT01248416|141684441|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71088984|NCT01248416|141684442|SUPERIORITY|||||||0.0003|||||||ANCOVA|||||||0.0003
71088985|NCT03499795|141684448|SUPERIORITY|||||||0.8633|||||||Clopper-Pearson|P-value was calculated based on the exact method of Clopper-Pearson and superiority was concluded if the one-sided p-value is \<0.05.||||||0.8633
71088986|NCT02741284|141684460|NON_INFERIORITY|A noninferiority margin of 30% (mean difference \<1.0 mmol/l) was pre-specified as it corresponds to an upper umbilical artery lactate cut-off value of 4.5 mmol/L, above which there is an increased risk of neonatal morbidity|Mean Difference (Final Values)|0.1||||0.69|TWO_SIDED|95.0|-0.5|0.7|||Wilcoxon (Mann-Whitney)|||||0.7|-0.5|0.69
71088987|NCT02741284|141684461|NON_INFERIORITY|Noninferiority margin 30%|Mean Difference (Final Values)|0.01|||<|0.05|TWO_SIDED|95.0|-0.01|0.03|||t-test, 2 sided|||pH||0.03|-0.01|<0.05
71088988|NCT02741284|141684462|SUPERIORITY||Risk Ratio (RR)|0.32|||<|0.05|TWO_SIDED|95.0|0.07|1.48|||Chi-squared|||Cesarean delivery||1.48|0.07|<0.05
71088989|NCT02741284|141684462|SUPERIORITY||Risk Ratio (RR)|0.0|||<|0.05|TWO_SIDED|95.0|0.0|0.0|||Chi-squared|||Cesarean delivery for non reassuring fetal status||0|0|<0.05
71088990|NCT02741284|141684462|SUPERIORITY||Risk Ratio (RR)|5.65|||<|0.05|TWO_SIDED|95.0|0.71|45.2|||Chi-squared|||Operative vaginal delivery||45.20|0.71|<0.05
71088991|NCT02741284|141684463|SUPERIORITY||Mean Difference (Net)|-1.5||||0.44|TWO_SIDED|95.0|-5.4|2.4|||t-test, 2 sided|||||2.4|-5.4|0.44
71088992|NCT02741284|141684464|SUPERIORITY||Mean Difference (Net)|-4.7||||0.06|TWO_SIDED|95.0|-9.6|0.1|||t-test, 2 sided|||||0.1|-9.6|0.06
71088993|NCT02741284|141684465|SUPERIORITY||Mean Difference (Net)|0.0||||0.99|TWO_SIDED|95.0|-1.0|1.0|||t-test, 2 sided|||||1.0|-1.0|0.99
71088994|NCT01516216|141684474|SUPERIORITY|||||||0.07|||||||Log Rank|||||||0.07
71088995|NCT01516216|141684475|SUPERIORITY|||||||0.43|||||||Log Rank|||||||0.43
71088996|NCT01516216|141684476|SUPERIORITY|||||||0.27|||||||Chi-squared|||||||0.27
71088997|NCT01516216|141684478|SUPERIORITY|||||||0.68|||||||Chi-squared|||||||0.68
71088998|NCT01516216|141684481|SUPERIORITY|||||||0.9801|||||||Chi-squared|||||||0.9801
71088999|NCT01516216|141684482|SUPERIORITY|||||||0.7444|||||||Chi-squared|||||||0.7444
71089000|NCT00879190|141684483|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
71089001|NCT00879190|141684484|SUPERIORITY_OR_OTHER|||||||0.03|||||||Fisher Exact|||||||0.03
71089002|NCT00879190|141684485|SUPERIORITY_OR_OTHER|||||||0.6|||||||Fisher Exact|||||||0.6
71089003|NCT01603602|141684486|SUPERIORITY||Least Squares (LS) Mean Difference|-0.66|||<|0.001|TWO_SIDED|95.0|-0.938|-0.379||MMRM model with baseline MAS-B score as covariate; factors of age, principal muscle group, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure, stratified by age and principal muscle group categories.|Mixed Model Repeated Measures (MMRM)|||||-0.379|-0.938|<0.001
71089004|NCT01603602|141684486|SUPERIORITY||LS Mean Difference|-0.71|||<|0.001|TWO_SIDED|95.0|-0.992|-0.426||MMRM model with baseline MAS-B score as covariate; factors of age, principal muscle group, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure, stratified by age and principal muscle group categories.|MMRM|||||-0.426|-0.992|<0.001
71089005|NCT01603602|141684487|SUPERIORITY||LS Mean Difference|0.21||||0.155|TWO_SIDED|95.0|-0.082|0.511||MMRM model with baseline MAS-B score as covariate; factors of age, principal muscle group, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure, stratified by age and principal muscle group categories.|MMRM|||||0.511|-0.082|0.155
71089006|NCT01603602|141684487|SUPERIORITY||LS Mean Difference|0.22||||0.147|TWO_SIDED|95.0|-0.079|0.523||MMRM model with baseline MAS-B score as covariate; factors of age, principal muscle group, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure, stratified by age and principal muscle group categories.|MMRM|||||0.523|-0.079|0.147
71089007|NCT01603602|141684488|SUPERIORITY||LS Mean Difference|-0.39||||0.111|TWO_SIDED|95.0|-0.861|0.091||ANCOVA model including baseline MAS-B score of finger flexor muscle group as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||||0.091|-0.861|0.111
71089008|NCT01603602|141684488|SUPERIORITY||LS Mean Difference|-0.44||||0.078|TWO_SIDED|95.0|-0.933|0.051||ANCOVA model including baseline MAS-B score of finger flexor muscle group as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||||0.051|-0.933|0.078
71089009|NCT01603602|141684489|SUPERIORITY||LS Mean Difference|-0.1||||0.636|TWO_SIDED|95.0|-0.498|0.305||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 8, Active Goal||0.305|-0.498|0.636
71089010|NCT01603602|141684489|SUPERIORITY||LS Mean Difference|-0.09||||0.658|TWO_SIDED|95.0|-0.502|0.318||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 8, Active Goal||0.318|-0.502|0.658
70946321|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6098|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6098
70946322|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1821|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1821
70946323|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1628|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1628
70946324|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8999|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8999
70946325|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.399|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3990
71089011|NCT01603602|141684489|SUPERIORITY||LS Mean Difference|0.24||||0.243|TWO_SIDED|95.0|-0.162|0.635||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 8, Passive Goal||0.635|-0.162|0.243
71089012|NCT01603602|141684489|SUPERIORITY||LS Mean Difference|0.17||||0.412|TWO_SIDED|95.0|-0.237|0.576||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 8, Passive Goal||0.576|-0.237|0.412
70946326|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2665|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2665
70946327|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4885|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4885
71089013|NCT01603602|141684489|SUPERIORITY||LS Mean Difference|-0.02||||0.904|TWO_SIDED|95.0|-0.408|0.361||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 12, Active Goal||0.361|-0.408|0.904
71089014|NCT01603602|141684489|SUPERIORITY||LS Mean Difference|-0.25||||0.2|TWO_SIDED|95.0|-0.641|0.135||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 12, Active Goal||0.135|-0.641|0.200
70946328|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6415|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6415
70946329|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2269|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2269
70946330|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3228|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3228
70946331|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1808|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1808
70946332|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3282|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3282
71089015|NCT01603602|141684489|SUPERIORITY||LS Mean Difference|0.59||||0.003|TWO_SIDED|95.0|0.21|0.978||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 12, Passive Goal||0.978|0.210|0.003
71089016|NCT01603602|141684489|SUPERIORITY||LS Mean Difference|0.19||||0.327|TWO_SIDED|95.0|-0.194|0.58||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 12, Passive Goal||0.580|-0.194|0.327
71089017|NCT01603602|141684490|SUPERIORITY||LS Mean Difference|12.1||||0.117|TWO_SIDED|95.0|-3.089|27.293||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2, Elbow||27.293|-3.089|0.117
71089018|NCT01603602|141684490|SUPERIORITY||LS Mean Difference|8.41||||0.273|TWO_SIDED|95.0|-6.717|23.527||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2, Elbow||23.527|-6.717|0.273
71089019|NCT01603602|141684490|SUPERIORITY||LS Mean Difference|14.71||||0.015|TWO_SIDED|95.0|2.958|26.458||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4, Elbow||26.458|2.958|0.015
71089020|NCT01603602|141684490|SUPERIORITY||LS Mean Difference|11.85||||0.046|TWO_SIDED|95.0|0.203|23.504||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4, Elbow||23.504|0.203|0.046
71089021|NCT01603602|141684490|SUPERIORITY||LS Mean Difference|20.97|||<|0.001|TWO_SIDED|95.0|8.801|33.137||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6, Elbow||33.137|8.801|<0.001
70946333|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0342|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0342
70946334|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4198|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4198
71089022|NCT01603602|141684490|SUPERIORITY||LS Mean Difference|11.35||||0.064|TWO_SIDED|95.0|-0.662|23.362||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6, Elbow||23.362|-0.662|0.064
71089023|NCT01603602|141684490|SUPERIORITY||LS Mean Difference|15.25||||0.013|TWO_SIDED|95.0|3.317|27.178||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8, Elbow||27.178|3.317|0.013
71089024|NCT01603602|141684490|SUPERIORITY||LS Mean Difference|7.22||||0.225|TWO_SIDED|95.0|-4.488|18.934||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8, Elbow||18.934|-4.488|0.225
71089025|NCT01603602|141684490|SUPERIORITY||LS Mean Difference|4.5||||0.409|TWO_SIDED|95.0|-6.239|15.236||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12, Elbow||15.236|-6.239|0.409
70946335|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9049|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9049
71089026|NCT01603602|141684490|SUPERIORITY||LS Mean Difference|3.86||||0.47|TWO_SIDED|95.0|-6.69|14.419||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12, Elbow||14.419|-6.690|0.470
71089027|NCT01603602|141684490|SUPERIORITY||LS Mean Difference|-6.13||||0.263|TWO_SIDED|95.0|-16.962|4.706||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2, Wrist||4.706|-16.962|0.263
71089028|NCT01603602|141684490|SUPERIORITY||LS Mean Difference|-14.6||||0.012|TWO_SIDED|95.0|-25.846|-3.36||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2, Wrist||-3.360|-25.846|0.012
71089029|NCT01603602|141684490|SUPERIORITY||LS Mean Difference|-10.64||||0.098|TWO_SIDED|95.0|-23.277|1.996||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4, Wrist||1.996|-23.277|0.098
71089030|NCT01603602|141684490|SUPERIORITY||LS Mean Difference|-13.1||||0.051|TWO_SIDED|95.0|-26.26|0.068||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4, Wrist||0.068|-26.260|0.051
71089031|NCT01603602|141684490|SUPERIORITY||LS Mean Difference|-17.11||||0.01|TWO_SIDED|95.0|-30.031|-4.189||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6, Wrist||-4.189|-30.031|0.010
71089032|NCT01603602|141684490|SUPERIORITY||LS Mean Difference|-11.25||||0.098|TWO_SIDED|95.0|-24.622|2.131||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6, Wrist||2.131|-24.622|0.098
71089033|NCT01603602|141684490|SUPERIORITY||LS Mean Difference|-17.71||||0.005|TWO_SIDED|95.0|-29.888|-5.537||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8, Wrist||-5.537|-29.888|0.005
71089034|NCT01603602|141684490|SUPERIORITY||LS Mean Difference|-15.74||||0.015|TWO_SIDED|95.0|-28.293|-3.194||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8, Wrist||-3.194|-28.293|0.015
71089035|NCT01603602|141684490|SUPERIORITY||LS Mean Difference|-15.25||||0.02|TWO_SIDED|95.0|-28.01|-2.492||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12, Wrist||-2.492|-28.010|0.020
71089036|NCT01603602|141684490|SUPERIORITY||LS Mean Difference|-13.52||||0.046|TWO_SIDED|95.0|-26.797|-0.243||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12, Wrist||-0.243|-26.797|0.046
71089037|NCT01935089|141684498|OTHER|"Hypothesis: 20 weeks of treatment (baseline week 3 to endpoint week 24) will result in a change in the levels of integrated HIV-1 DNA (copies/CD4 T cell Variable name: intDNA).~Test if the mean difference (IntDNA wk24 - IntDNAwk3) is significantly different from zero (i.e. no change) Null hypothesis: Mean (IntDNA wk24 - IntDNAwk3) = 0; reject if p\<0.05"||||||0.0797||||||significant if \<0.05|signed rank test|||||||0.0797
71089038|NCT00723229|141684499|SUPERIORITY_OR_OTHER||Incidence Risk Ratio|0.2|||<|0.001|TWO_SIDED|95.0|0.17|0.25|||Regression, poisson|Adjusted for period effects.||The trial had 80% power to detect a 35% reduction in genital shedding rates for acyclovir 400 mg twice daily.||0.25|0.17|<0.001
71089039|NCT00723229|141684499|SUPERIORITY|Adjusted for period effects.|Risk Ratio (RR)|0.05|||<|0.001|TWO_SIDED|95.0|0.03|0.08|||Regression, Poisson|||Among HIV seronegative individuals.||0.08|0.03|<0.001
71089040|NCT00723229|141684499|SUPERIORITY|Adjusted for period effects.|Risk Ratio (RR)|0.5|||<|0.001|TWO_SIDED|95.0|0.4|0.6|||Regression, Poisson|||Among HIV seropositive individuals.||0.6|0.4|<0.001
71126258|NCT02986854|141758866|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|22.18|||||TWO_SIDED|95.0|6.89|35.38|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||35.38|6.89|
71089041|NCT01668797|141684518|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|The log-rank test was based on time to exacerbation of psychotic symptoms/impending relapse.||The total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 1:1 (brexpiprazole:placebo) randomization ratio.||||<0.0001
71089042|NCT01668797|141684519|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Chi-squared|||The percentage of participants with impending relapse in treatment groups (Brexpiprazole and placebo) in final analysis for participants meeting at least one of the criteria.||||<0.0001
71089043|NCT01668797|141684520|SUPERIORITY_OR_OTHER|||||||0.2296|||||||Chi-squared|||Statistical analysis at Week 6.||||0.2296
71089044|NCT01668797|141684520|SUPERIORITY_OR_OTHER|||||||0.2051|||||||Chi-squared|||Statistical analysis at Week 12.||||0.2051
71089045|NCT01668797|141684520|SUPERIORITY_OR_OTHER|||||||0.7354|||||||Chi-squared|||Statistical analysis at Week 24.||||0.7354
71089046|NCT01668797|141684520|SUPERIORITY_OR_OTHER|||||||0.1977|||||||Chi-squared|||Statistical analysis at Week 36.||||0.1977
71089047|NCT01668797|141684520|SUPERIORITY_OR_OTHER|||||||0.8734|||||||Chi-squared|||Statistical analysis at Week 52.||||0.8734
71089048|NCT01668797|141684520|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Chi-squared|||Statistical analysis at Last Visit.||||0.0007
71089049|NCT01668797|141684521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3||||0.0664|TWO_SIDED|95.0|-6.82|0.23|||Mixed Models Analysis|||Statistical analysis of treatment comparisons at Week 6.||0.23|-6.82|0.0664
71089050|NCT01668797|141684521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.31||||0.0301|TWO_SIDED|95.0|-10.1|-0.52|||Mixed Models Analysis|||Statistical analysis of treatment comparisons at Week 12.||-0.52|-10.1|0.0301
71089051|NCT01668797|141684521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.77||||0.0226|TWO_SIDED|95.0|-8.86|-0.68|||Mixed Models Analysis|||Statistical analysis of treatment comparisons at Week 24.||-0.68|-8.86|0.0226
71126259|NCT02986854|141758866|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-0.55|||||TWO_SIDED|95.0|-12.11|11.03|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||11.03|-12.11|
71126260|NCT02986854|141758866|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|40.06|||||TWO_SIDED|95.0|24.26|54.95|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||54.95|24.26|
70946336|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0456|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0456
71089052|NCT01668797|141684521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.03||||0.0086|TWO_SIDED|95.0|-10.5|-1.59|||Mixed Models Analysis|||Statistical analysis of treatment comparisons at Week 36.||-1.59|-10.5|0.0086
71089053|NCT01668797|141684521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.31||||0.28|TWO_SIDED|95.0|-18.1|5.46|||Mixed Models Analysis|||Statistical analysis of treatment comparisons at Week 52.||5.46|-18.1|0.2800
71089054|NCT01668797|141684521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.42||||0.0011|TWO_SIDED|95.0|-7.01|-1.82|||Mixed Models Analysis|||Statistical analysis at across visits||-1.82|-7.01|0.0011
71089055|NCT01668797|141684522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.04||||0.0683|TWO_SIDED|95.0|-6.31|0.23|||ANCOVA|||Statistical analysis at Week 6.||0.23|-6.31|0.0683
71126261|NCT02986854|141758866|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|42.4|||||TWO_SIDED|95.0|26.71|57.17|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||57.17|26.71|
71089056|NCT01668797|141684522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.05||||0.0174|TWO_SIDED|95.0|-9.2|-0.9|||ANCOVA|||Statistical analysis at Week 12.||-0.90|-9.20|0.0174
71089057|NCT01668797|141684522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.59||||0.0008|TWO_SIDED|95.0|-12.0|-3.18|||ANCOVA|||Statistical analysis at Week 24.||-3.18|-12.0|0.0008
71126262|NCT02986854|141758866|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|41.21|||||TWO_SIDED|95.0|26.12|55.55|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||55.55|26.12|
71126263|NCT02986854|141758866|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-2.34|||||TWO_SIDED|95.0|-10.41|5.73|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||5.73|-10.41|
71126264|NCT02986854|141758866|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|22.58|||||TWO_SIDED|95.0|15.26|32.08|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||32.08|15.26|
71126265|NCT02986854|141758866|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|22.22|||||TWO_SIDED|95.0|14.86|31.74|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||31.74|14.86|
70946337|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2463|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2463
71089058|NCT01668797|141684522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.02||||0.0005|TWO_SIDED|95.0|-12.4|-3.59|||ANCOVA|||Statistical analysis at Week 36.||-3.59|-12.4|0.0005
71089059|NCT01668797|141684522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.95||||0.0007|TWO_SIDED|95.0|-12.5|-3.41|||ANCOVA|||Statistical analysis at Week 52.||-3.41|-12.5|0.0007
71089060|NCT01668797|141684523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.0507|TWO_SIDED|95.0|-2.23|0.0|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.00|-2.23|0.0507
71089061|NCT01668797|141684523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.87||||0.008|TWO_SIDED|95.0|-3.24|-0.5|||Mixed Models Analysis|||Statistical analysis at Week 12.||-0.50|-3.24|0.0080
71089062|NCT01668797|141684523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.56||||0.0215|TWO_SIDED|95.0|-2.89|-0.24|||Mixed Models Analysis|||Statistical analysis at Week 24.||-0.24|-2.89|0.0215
71089063|NCT01668797|141684523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88||||0.0053|TWO_SIDED|95.0|-3.19|-0.58|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.58|-3.19|0.0053
71089064|NCT01668797|141684523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.71||||0.339|TWO_SIDED|95.0|-5.2|-0.22|||Mixed Models Analysis|||Statistical analysis at Week 52.||-0.22|-5.20|0.339
71089065|NCT01668797|141684523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.32|-0.88|||Mixed Models Analysis|||Statistical analysis at across visits.||-0.88|-2.32|< 0.0001
71126266|NCT02986854|141758866|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|22.41|||||TWO_SIDED|95.0|15.08|31.9|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||31.90|15.08|
71089066|NCT01668797|141684524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94||||0.1093|TWO_SIDED|95.0|-2.1|0.21|||ANCOVA|||Statistical analysis at Week 6.||0.21|-2.10|0.1093
71089067|NCT01668797|141684524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.86||||0.0089|TWO_SIDED|95.0|-3.25|-0.47|||ANOVA|||Statistical analysis at Week 12.||-0.47|-3.25|0.0089
71089068|NCT01668797|141684524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.74||||0.0005|TWO_SIDED|95.0|-4.26|-1.22|||ANCOVA|||Statistical analysis at Week 24.||-1.22|-4.26|0.0005
71089069|NCT01668797|141684524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.94||||0.0001|TWO_SIDED|95.0|-4.43|-1.44|||ANCOVA|||Statistical analysis at Week 36.||-1.44|-4.43|0.0001
71089070|NCT01668797|141684524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.18|||<|0.0001|TWO_SIDED|95.0|-4.7|-1.66|||ANCOVA|||Statistical analysis at Week 52||-1.66|-4.70|<0.0001
71089071|NCT01668797|141684525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.165|TWO_SIDED|95.0|-1.66|0.29|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.29|-1.66|0.1650
71089072|NCT01668797|141684525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.2001|TWO_SIDED|95.0|-1.97|0.42|||Mixed Models Analysis|||Statistical analysis at Week 12.||0.42|-1.97|0.2001
71089073|NCT01668797|141684525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95||||0.0939|TWO_SIDED|95.0|-2.07|0.16|||Mixed Models Analysis|||Statistical analysis at Week 24.||0.16|-2.07|0.0939
71089074|NCT01668797|141684525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05||||0.1396|TWO_SIDED|95.0|-2.44|0.35|||Mixed Models Analysis|||Statistical analysis at Week 36.||0.35|-2.44|0.1396
71089075|NCT01668797|141684525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43||||0.847|TWO_SIDED|95.0|-4.14|5.0|||Mixed Models Analysis|||Statistical analysis at Week 52.||5.00|-4.14|0.8470
71089076|NCT01668797|141684525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.2258|TWO_SIDED|95.0|-1.24|0.3|||Mixed Models Analysis|||Statistical analysis at across visits.||0.3|-1.24|0.2258
71089077|NCT01668797|141684526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76||||0.0981|TWO_SIDED|95.0|-1.65|0.14|||ANCOVA|||Statistical analysis at Week 6.||0.14|-1.65|0.0981
71089078|NCT01668797|141684526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22||||0.0264|TWO_SIDED|95.0|-2.3|-0.15|||ANCOVA|||Statistical analysis at Week 12.||-0.15|-2.30|0.0264
71089079|NCT01668797|141684526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55||||0.0078|TWO_SIDED|95.0|-2.69|-0.42|||ANCOVA|||Statistical analysis at Week 24.||-0.42|-2.69|0.0078
71089080|NCT01668797|141684526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.57||||0.0101|TWO_SIDED|95.0|-2.77|-0.38|||ANCOVA|||Statistical analysis at Week 36.||-0.38|-2.77|0.0101
71089081|NCT01668797|141684526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24||||0.0516|TWO_SIDED|95.0|-2.5|0.01|||ANCOVA|||Statistical analysis at Week 52||0.01|-2.50|0.0516
71089082|NCT01668797|141684527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.0279|TWO_SIDED|95.0|-0.53|-0.03|||Mixed Models Analysis|||Statistical analysis at Week 6.||-0.03|-0.53|0.0279
71089083|NCT01668797|141684527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.0117|TWO_SIDED|95.0|-0.68|-0.09|||Mixed Models Analysis|||Statistical analysis at Week 12.||-0.09|-0.68|0.0117
71089084|NCT01668797|141684527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.0105|TWO_SIDED|95.0|-0.64|-0.09|||Mixed Models Analysis|||Statistical analysis at Week 24.||-0.09|-0.64|0.0105
71089085|NCT01668797|141684527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.0007|TWO_SIDED|95.0|-0.87|-0.25|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.25|-0.87|0.0007
71089086|NCT01668797|141684527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.078|TWO_SIDED|95.0|-1.09|0.06|||Mixed Models Analysis|||Statistical analysis at Week 52.||0.06|-1.09|0.0780
71089087|NCT01668797|141684527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0006|TWO_SIDED|95.0|-0.54|-0.15|||Mixed Models Analysis|||Statistical analysis at across visits.||-0.15|-0.54|0.0006
71089088|NCT01668797|141684528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0284|TWO_SIDED|95.0|-0.47|-0.03|||ANCOVA|||Statistical analysis at Week 6.||-0.03|-0.47|0.0284
71089089|NCT01668797|141684528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.0056|TWO_SIDED|95.0|-0.62|-0.11|||ANCOVA|||Statistical analysis at Week 12.||-0.11|-0.62|0.0056
71089090|NCT01668797|141684528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0002|TWO_SIDED|95.0|-0.76|-0.24|||ANCOVA|||Statistical analysis at Week 24.||-0.24|-0.76|0.0002
71089091|NCT01668797|141684528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|||<|0.0001|TWO_SIDED|95.0|-0.82|-0.3|||ANCOVA|||Statistical analysis at Week 36.||-0.30|-0.82|<.0001
71089092|NCT01668797|141684528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.0002|TWO_SIDED|95.0|-0.79|-0.26|||ANCOVA|||Statistical analysis at Week 52||-0.26|-0.79|0.0002
71089093|NCT01668797|141684529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.0387|TWO_SIDED|95.0|-0.6|-0.2|||Cochran-Mantel-Haenszel|||Statistical analysis at Week 6.||-0.20|-0.60|0.0387
71089094|NCT01668797|141684529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.0185|TWO_SIDED|95.0|-0.75|-0.07|||Cochran-Mantel-Haenszel|||Statistical analysis at Week 12.||-0.07|-0.75|0.0185
71089095|NCT01668797|141684529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.001|TWO_SIDED|95.0|-0.97|-0.24|||Cochran-Mantel-Haenszel|||Statistical analysis at Week 24.||-0.24|-0.97|0.0010
71089096|NCT01668797|141684529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.0004|TWO_SIDED|95.0|-1.02|-0.3|||Cochran-Mantel-Haenszel|||Statistical analysis at Week 36.||-0.30|-1.02|0.0004
71089097|NCT01668797|141684529|SUPERIORITY_OR_OTHER||Treatment difference|-0.61||||0.0009|TWO_SIDED|95.0|-0.96|-0.25|||Cochran-Mantel-Haenszel|||Statistical analysis at Week 52.||-0.25|-0.96|0.0009
71089098|NCT01668797|141684530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01||||0.6525|TWO_SIDED|95.0|-3.47|5.49|||Mixed Models Analysis|||Statistical analysis at Week 24.||5.49|-3.47|0.6525
71089099|NCT01668797|141684530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.08||||0.1677|TWO_SIDED|95.0|-2.71|14.87|||Mixed Models Analysis|||Statistical analysis at Week 52.||14.87|-2.71|0.1677
71089100|NCT01668797|141684530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.55||||0.2347|TWO_SIDED|95.0|-2.41|9.5|||Mixed Models Analysis|||Statistical analysis at across visits.||9.5|-2.41|0.2347
71089101|NCT01668797|141684531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.79||||0.0285|TWO_SIDED|95.0|0.4|7.17|||ANCOVA|||Statistical analysis at Week 24.||7.17|0.40|0.0285
71089102|NCT01668797|141684531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.75||||0.0071|TWO_SIDED|95.0|1.31|8.18|||ANCOVA|||Statistical analysis at Week 52.||8.18|1.31|0.0071
71089103|NCT01668797|141684532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.61||||0.329|TWO_SIDED|95.0|-1.65|4.88|||Mixed Models Analysis|||Statistical analysis at Week 12.||4.88|-1.65|0.3290
71089104|NCT01668797|141684532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.66||||0.1765|TWO_SIDED|95.0|-1.22|6.54|||Mixed Models Analysis|||Statistical analysis at Week 24.||6.54|-1.22|0.1765
71089105|NCT01668797|141684532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5||||0.0331|TWO_SIDED|95.0|0.38|8.63|||Mixed Models Analysis|||Statistical analysis at Week 36.||8.63|0.38|0.0331
71089106|NCT01668797|141684532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.88||||0.0522|TWO_SIDED|95.0|-0.06|11.82|||Mixed Models Analysis|||Statistical analysis at Week 52.||11.82|-0.06|0.0522
71089107|NCT01668797|141684532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.66||||0.0281|TWO_SIDED|95.0|0.41|6.92|||Mixed Models Analysis|||Statistical analysis at across visits.||6.92|0.41|0.0281
71089108|NCT01668797|141684533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.88||||0.0111|TWO_SIDED|95.0|0.9|6.86|||ANCOVA|||Statistical analysis at Week 12.||6.86|0.90|0.0111
71089109|NCT01668797|141684533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.36||||0.0014|TWO_SIDED|95.0|2.1|8.62|||ANCOVA|||Statistical analysis at Week 24.||8.62|2.10|0.0014
71089110|NCT01668797|141684533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.81|||<|0.0001|TWO_SIDED|95.0|3.61|10.0|||ANCOVA|||Statistical analysis at Week 36.||10.00|3.61|<.0001
71089111|NCT01668797|141684533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.55||||0.0001|TWO_SIDED|95.0|3.28|9.83|||ANCOVA|||Statistical analysis at Week 52.||9.83|3.28|0.0001
71089112|NCT01668797|141684534|SUPERIORITY_OR_OTHER|||||||0.0014|TWO_SIDED||||||Log Rank|||||||0.0014
71089113|NCT01668797|141684535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.1577|TWO_SIDED|95.0|-1.02|0.17|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.17|-1.02|0.1577
71089114|NCT01668797|141684535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.1685|TWO_SIDED|95.0|-1.61|0.28|||Mixed Models Analysis|||Statistical analysis at Week 12.||0.28|-1.61|0.1685
71089115|NCT01668797|141684535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.2815|TWO_SIDED|95.0|-1.43|0.42|||Mixed Models Analysis|||Statistical analysis at Week 24.||0.42|-1.43|0.2815
71089116|NCT01668797|141684535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14||||0.0286|TWO_SIDED|95.0|-2.16|-0.12|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.12|-2.16|0.0286
71089117|NCT01668797|141684535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.1803|TWO_SIDED|95.0|-2.58|0.51|||Mixed Models Analysis|||Statistical analysis at Week 52.||0.51|-2.58|0.1803
71089118|NCT01668797|141684535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.0077|TWO_SIDED|95.0|-1.12|-0.17|||Mixed Models Analysis|||Statistical analysis at across visits.||-0.17|-1.12|0.0077
71089119|NCT01668797|141684536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.1852|TWO_SIDED|95.0|-1.06|0.21|||ANCOVA|||Statistical analysis at Week 6.||0.21|-1.06|0.1852
71089120|NCT01668797|141684536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63||||0.143|TWO_SIDED|95.0|-1.47|0.21|||ANCOVA|||Statistical analysis at Week 12.||0.21|-1.47|0.1430
71089121|NCT01668797|141684536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.0323|TWO_SIDED|95.0|-2.06|-0.09|||ANCOVA|||Statistical analysis at Week 24.||-0.09|-2.06|0.0323
71089122|NCT01668797|141684536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.0071|TWO_SIDED|95.0|-2.31|-0.37|||ANCOVA|||Statistical analysis at Week 36.||-0.37|-2.31|0.0071
71089123|NCT01668797|141684536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54||||0.0023|TWO_SIDED|95.0|-2.52|-0.56|||ANCOVA|||Statistical analysis at Week 52.||-0.56|-2.52|0.0023
71089124|NCT01668797|141684537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.0288|TWO_SIDED|95.0|-2.54|-0.14|||Mixed Models Analysis|||Statistical analysis at Week 6.||-0.14|-2.54|0.0288
71089125|NCT01668797|141684537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.02||||0.0128|TWO_SIDED|95.0|-3.6|-0.44|||Mixed Models Analysis|||Statistical analysis at Week 12.||-0.44|-3.60|0.0128
71089126|NCT01668797|141684537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.59||||0.0462|TWO_SIDED|95.0|-3.15|0.03|||Mixed Models Analysis|||Statistical analysis at Week 24.||0.03|-3.15|0.0462
71089127|NCT01668797|141684537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.29||||0.0074|TWO_SIDED|95.0|-3.94|-0.64|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.64|-3.94|0.0074
71089128|NCT01668797|141684537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.0136|TWO_SIDED|95.0|-6.05|-0.75|||Mixed Models Analysis|||Statistical analysis at Week 52||-0.75|-6.05|0.0136
71089129|NCT01668797|141684537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.91||||0.0001|TWO_SIDED|95.0|-2.84|-0.97|||Mixed Models Analysis|||Statistical analysis at across visits.||-0.97|-2.84|0.0001
71089130|NCT01668797|141684538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.0695|TWO_SIDED|95.0|-2.26|0.09|||ANCOVA|||Statistical analysis at Week 6.||0.09|-2.26|0.0695
71089131|NCT01668797|141684538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93||||0.0089|TWO_SIDED|95.0|-3.38|-0.49|||ANCOVA|||Statistical analysis at Week 12.||-0.49|-3.38|0.0089
71089132|NCT01668797|141684538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.83||||0.0004|TWO_SIDED|95.0|-4.39|-1.27|||ANCOVA|||Statistical analysis at Week 24.||-1.27|-4.39|0.0004
71089133|NCT01668797|141684538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.09||||0.0001|TWO_SIDED|95.0|-4.63|-1.54|||ANCOVA|||Statistical analysis at Week 36.||-1.54|-4.63|0.0001
71089134|NCT01668797|141684538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.44|||<|0.0001|TWO_SIDED|95.0|-4.99|-1.89|||ANCOVA|||Statistical analysis at Week 52.||-1.89|-4.99|<0.0001
71089135|NCT01668797|141684539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.1969|TWO_SIDED|95.0|-1.66|0.35|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.35|-1.66|0.1969
71089136|NCT01668797|141684539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.2007|TWO_SIDED|95.0|-2.04|0.43|||Mixed Models Analysis|||Statistical analysis at Week 12.||0.43|-2.04|0.2007
71089137|NCT01668797|141684539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17||||0.0436|TWO_SIDED|95.0|-2.3|-0.03|||Mixed Models Analysis|||Statistical analysis at Week 24.||-0.03|-2.30|0.0436
71089138|NCT01668797|141684539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51||||0.0444|TWO_SIDED|95.0|-2.97|-0.04|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.04|-2.97|0.0444
71089139|NCT01668797|141684539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.8927|TWO_SIDED|95.0|-4.4|5.02|||Mixed Models Analysis|||Statistical analysis at Week 52.||5.02|-4.40|0.8927
71089140|NCT01668797|141684539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.2154|TWO_SIDED|95.0|-1.34|0.31|||Mixed Models Analysis|||Statistical analysis at across visits.||0.31|-1.34|0.2154
71089141|NCT01668797|141684540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||0.0707|TWO_SIDED|95.0|-1.78|0.07|||ANCOVA|||Statistical analysis at Week 6.||0.07|-1.78|0.0707
71089142|NCT01668797|141684540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24||||0.0276|TWO_SIDED|95.0|-2.35|-0.14|||ANCOVA|||Statistical analysis at Week 12.||-0.14|-2.35|0.0276
71089143|NCT01668797|141684540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.59||||0.0065|TWO_SIDED|95.0|-2.72|-0.45|||ANCOVA|||Statistical analysis at Week 24.||-0.45|-2.72|0.0065
71089144|NCT01668797|141684540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63||||0.0085|TWO_SIDED|95.0|-2.84|-0.42|||ANCOVA|||Statistical analysis at Week 36.||-0.42|-2.84|0.0085
71089145|NCT01668797|141684540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.23||||0.063|TWO_SIDED|95.0|-2.52|0.07|||ANCOVA|||Statistical analysis at Week 52.||0.07|-2.52|0.0630
71089146|NCT01668797|141684541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.2251|TWO_SIDED|95.0|-1.33|0.31|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.31|-1.33|0.2251
71089147|NCT01668797|141684541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13||||0.0368|TWO_SIDED|95.0|-2.19|-0.07|||Mixed Models Analysis|||Statistical analysis at Week 12.||-0.07|-2.19|0.0368
71089148|NCT01668797|141684541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.53||||0.0024|TWO_SIDED|95.0|-2.51|-0.56|||Mixed Models Analysis|||Statistical analysis at Week 24.||-0.56|-2.51|0.0024
71089149|NCT01668797|141684541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.48||||0.0293|TWO_SIDED|95.0|-2.8|-0.15|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.15|-2.80|0.0293
71089150|NCT01668797|141684541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.9632|TWO_SIDED|95.0|-3.32|3.17|||Mixed Models Analysis|||Statistical analysis at Week 52.||3.17|-3.32|0.9632
71089151|NCT01668797|141684541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||0.0029|TWO_SIDED|95.0|-1.63|-0.34|||Mixed Models Analysis|||Statistical analysis at across visits.||-0.34|-1.63|0.0029
71089152|NCT01668797|141684542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.1062|TWO_SIDED|95.0|-1.44|0.14|||ANCOVA|||Statistical analysis at Week 6.||0.14|-1.44|0.1062
71089153|NCT01668797|141684542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.37||||0.0051|TWO_SIDED|95.0|-2.33|-0.42|||ANCOVA|||Statistical analysis at Week 12.||-0.42|-2.33|0.0051
71089154|NCT01668797|141684542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05||||0.0001|TWO_SIDED|95.0|-3.08|-1.01|||ANCOVA|||Statistical analysis at Week 24.||-1.01|-3.08|0.0001
71089155|NCT01668797|141684542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.94||||0.0004|TWO_SIDED|95.0|-3.0|-0.89|||ANCOVA|||Statistical analysis at Week 36.||-0.89|-3.00|0.0004
71089156|NCT01668797|141684542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69||||0.0035|TWO_SIDED|95.0|-2.81|-0.56|||ANCOVA|||Statistical analysis at Week 52.||-0.56|-2.81|0.0035
71089157|NCT01668797|141684543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.1465|TWO_SIDED|95.0|-0.85|0.13|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.13|-0.85|0.1465
71089158|NCT01668797|141684543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.2154|TWO_SIDED|95.0|-1.27|0.29|||Mixed Models Analysis|||Statistical analysis at Week 12.||0.29|-1.27|0.2154
71089159|NCT01668797|141684543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.2696|TWO_SIDED|95.0|-1.23|0.35|||Mixed Models Analysis|||Statistical analysis at Week 24.||0.35|-1.23|0.2696
71089160|NCT01668797|141684543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07||||0.0179|TWO_SIDED|95.0|-1.95|-0.19|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.19|-1.95|0.0179
71089161|NCT01668797|141684543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14||||0.0875|TWO_SIDED|95.0|-2.46|0.18|||Mixed Models Analysis|||Statistical analysis at Week 52.||0.18|-2.46|0.0875
71089162|NCT01668797|141684543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.0021|TWO_SIDED|95.0|-1.08|-0.24|||Mixed Models Analysis|||Statistical analysis at across visits.||-0.24|-1.08|0.0021
71089163|NCT01668797|141684544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.2135|TWO_SIDED|95.0|-0.86|0.19|||ANCOVA|||Statistical analysis at Week 6.||0.19|-0.86|0.2135
71089164|NCT01668797|141684544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.2437|TWO_SIDED|95.0|-1.13|0.29|||ANCOVA|||Statistical analysis at Week 12.||0.29|-1.13|0.2437
71089165|NCT01668797|141684544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81||||0.0635|TWO_SIDED|95.0|-1.66|0.05|||ANCOVA|||Statistical analysis at Week 24.||0.05|-1.66|0.0635
71089166|NCT01668797|141684544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07||||0.0144|TWO_SIDED|95.0|-1.92|-0.22|||ANCOVA|||Statistical analysis at Week 36.||-0.22|-1.92|0.0144
71089167|NCT01668797|141684544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26||||0.0046|TWO_SIDED|95.0|-2.12|-0.39|||ANCOVA|||Statistical analysis at Week 52.||-0.39|-2.12|0.0046
71089168|NCT01668797|141684545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.164|TWO_SIDED|95.0|-1.14|0.19|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.19|-1.14|0.1640
71089169|NCT01668797|141684545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.5466|TWO_SIDED|95.0|-1.04|0.55|||Mixed Models Analysis|||Statistical analysis at Week 12.||0.55|-1.04|0.5466
71089170|NCT01668797|141684545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.9417|TWO_SIDED|95.0|-0.81|0.87|||Mixed Models Analysis|||Statistical analysis at Week 24.||0.87|-0.81|0.9417
71089171|NCT01668797|141684545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.6257|TWO_SIDED|95.0|-1.25|0.76|||Mixed Models Analysis|||Statistical analysis at Week 36.||0.76|-1.25|0.6257
71089172|NCT01668797|141684545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.7437|TWO_SIDED|95.0|-1.68|1.21|||Mixed Models Analysis|||Statistical analysis at Week 52.||1.21|-1.68|0.7437
71089173|NCT01668797|141684545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.4506|TWO_SIDED|95.0|-0.62|0.28|||Mixed Models Analysis|||Statistical analysis at across visits.||0.28|-0.62|0.4506
71089174|NCT01668797|141684546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67||||0.0467|TWO_SIDED|95.0|-1.32|-0.06|||ANCOVA|||Statistical analysis at Week 6.||-0.06|-1.32|0.0467
71089175|NCT01668797|141684546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.1599|TWO_SIDED|95.0|-1.33|0.22|||ANCOVA|||Statistical analysis at Week 12.||0.22|-1.33|0.1599
71089176|NCT01668797|141684546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.1417|TWO_SIDED|95.0|-1.35|0.19|||ANCOVA|||Statistical analysis at Week 24.||0.19|-1.35|0.1417
71089177|NCT01668797|141684546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.0724|TWO_SIDED|95.0|-1.47|0.06|||ANCOVA|||Statistical analysis at Week 36.||0.06|-1.47|0.0724
71089178|NCT01668797|141684546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72||||0.0608|TWO_SIDED|95.0|-1.47|0.03|||ANCOVA|||Statistical analysis at Week 52.||0.03|-1.47|0.0608
71089179|NCT02530385|141684547|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
71089180|NCT02530385|141684548|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|||||||0.70
71089181|NCT02530385|141684549|SUPERIORITY|||||||0.93|||||||Mixed Models Analysis|||||||0.93
71089182|NCT02530385|141684550|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|||||||0.90
71089183|NCT02530385|141684551|SUPERIORITY|||||||0.32|||||||Mixed Models Analysis|||||||0.32
71089184|NCT01569022|141684553|EQUIVALENCE|The primary endpoint of the study was tested by comparing difference in residual AHI using the paired t test|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71089185|NCT01569022|141684554|EQUIVALENCE|t test assuming unequal variance||||||0.97|||||||t-test, 2 sided|||ESS||||0.97
71089186|NCT01569022|141684554|EQUIVALENCE|t test assuming unequal variance||||||0.98|||||||t-test, 2 sided|||PCL||||0.98
71089187|NCT01569022|141684554|EQUIVALENCE|t-test assuming non unequal variance||||||0.31|||||||t-test, 2 sided|||PSQI||||0.31
71089188|NCT01569022|141684555|EQUIVALENCE|t test assuming unequal variance||||||0.54|||||||t-test, 2 sided|||||||0.54
71089189|NCT01569022|141684556|EQUIVALENCE|t test assuming unequal variance|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71089190|NCT00433836|141684558|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority delta of 3.5 mm Hg|Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-3.8|1.17|||ANOVA|||||1.17|-3.80|
70857649|NCT02054481|141201291|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.6||||0.0355|TWO_SIDED|95.0|1.0|28.2|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|Week 12||28.2|1.0|0.0355
71089191|NCT01026493|141684587|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.95|TWO_SIDED|95.0|0.66|1.48|||Log Rank|Two-sided test|Reference level = Arm 1/BEV-NAIVE|||1.48|0.66|0.95
71089192|NCT01026493|141684587|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.93|TWO_SIDED|95.0|0.57|1.53|||Log Rank|Two-sided test|Reference level = Arm 1/BEV-FAILURE|||1.53|0.57|0.93
71089193|NCT02295644|141684597|SUPERIORITY_OR_OTHER|||||||0.17||||||Interaction test of duty cycle and intensity for self reported pain score|ANOVA|||||||0.17
71089194|NCT02295644|141684597|SUPERIORITY_OR_OTHER|||||||0.14||||||Main effect of duty cycle on self reported pain score.|ANOVA|||||||0.14
71089195|NCT02295644|141684597|SUPERIORITY_OR_OTHER|||||||1||||||Main effect of intensity on self reported pain score.|ANOVA|||||||1.0
71089196|NCT02295644|141684598|SUPERIORITY_OR_OTHER|||||||0.24||||||Main effect for duty cycle.|ANOVA|||||||.24
71089197|NCT02295644|141684598|SUPERIORITY_OR_OTHER|||||||0.019||||||Main effect for intensity.|ANOVA|||||||0.019
71089198|NCT02295644|141684598|SUPERIORITY_OR_OTHER|||||||0.17|||||||ANOVA|||Interaction of intensity and duty cycle.||||0.17
71089199|NCT02295644|141684599|SUPERIORITY_OR_OTHER|||||||0.034||||||Main effect for duty cycle.|ANOVA|||||||0.034
71089200|NCT02295644|141684599|SUPERIORITY_OR_OTHER|||||||0.475|||||||ANOVA|||Main effect for intensity.||||0.475
71089201|NCT02295644|141684599|SUPERIORITY_OR_OTHER|||||||0.178|||||||ANOVA|||Interaction of intensity and duty cycle.||||.178
71089202|NCT00324155|141684601|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.179||||0.4067|TWO_SIDED|95.0|0.799|1.74|||Cochran-Mantel-Haenszel|Stratified for metastasis stage (M0 vs M1a vs M1b vs M1c) and ECOG performance status (0 vs 1) recorded at randomization.||Analysis stratified for metastasis stage (M0 vs M1a vs M1b vs M1c) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs 1) recorded at randomization.||1.740|0.799|0.4067
71089203|NCT00324155|141684609|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.716||||0.0009|TWO_SIDED|95.0|0.588|0.872||p-value was via stratified log-rank test|Log Rank||Hazard ratio via stratified Cox proportional hazards model.|Analysis stratified for metastasis stage (M0 vs M1a vs M1b vs M1c) and Eastern Cooperative Oncology Group performance status (0 vs 1) recorded at randomization.||0.872|0.588|0.0009
71089204|NCT03307174|141684613|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
71089205|NCT00111761|141684622|SUPERIORITY_OR_OTHER||Percentage of participants|25.0||||||95.0|9.8|46.7||||||||46.7|9.8|
71089206|NCT00111761|141684623|SUPERIORITY_OR_OTHER||Percentage of participants|58.0||||||95.0|34.0|80.0||||||||80|34|
71089207|NCT00111761|141684624|SUPERIORITY_OR_OTHER||Percentage|33.3||||||95.0|15.6|55.3||||||||55.3|15.6|
71089208|NCT00111761|141684629|SUPERIORITY_OR_OTHER||Percentage of participants|47.4||||||95.0|24.4|71.1||||||||71.1|24.4|
71089209|NCT00461734|141684661|SUPERIORITY_OR_OTHER|||||||0.4347|||||||two-sided z-test|||||||0.4347
71089210|NCT00461734|141684662|SUPERIORITY_OR_OTHER|||||||0.338|||||||two-sided z-test|||||||0.338
71089211|NCT00461734|141684663|SUPERIORITY_OR_OTHER|||||||0.2257|||||||Wilcoxon (Mann-Whitney)|||||||0.2257
71089212|NCT00461734|141684664|SUPERIORITY_OR_OTHER|||||||0.548|||||||Wilcoxon (Mann-Whitney)|||||||0.5480
71089213|NCT00461734|141684665|SUPERIORITY_OR_OTHER|||||||0.8868|||||||Wilcoxon (Mann-Whitney)|||||||0.8868
71089214|NCT00461734|141684666|SUPERIORITY_OR_OTHER|||||||0.6151|||||||Wilcoxon (Mann-Whitney)|||||||0.6151
71089215|NCT00461734|141684670|SUPERIORITY_OR_OTHER|||||||0.0525|||||||t-test, 2 sided|||||||0.0525
71089216|NCT00461734|141684671|SUPERIORITY_OR_OTHER|||||||0.1852|||||||t-test, 2 sided|||||||0.1852
71089217|NCT00461734|141684673|SUPERIORITY_OR_OTHER|||||||0.9719|||||||Wilcoxon (Mann-Whitney)|||||||0.9719
71089218|NCT00461734|141684674|SUPERIORITY_OR_OTHER|||||||0.8779|||||||Wilcoxon (Mann-Whitney)|||||||0.8779
71089219|NCT02139540|141684694|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||The primary outcome (HDRS-21) was analyzed with a repeated-measures mixed effects linear model using restricted maximum likelihood estimation. To adjust for the observed carryover effect, the model included a randomization group term and a three-way interaction (treatment × time × randomization group)||||<0.05
71089220|NCT02139540|141684695|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71089221|NCT00720499|141684705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.017||0.8937|TWO_SIDED|95.0|-0.035|0.031|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.031|-0.035|0.8937
71089222|NCT00720499|141684706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.019||0.2425|TWO_SIDED|95.0|-0.015|0.061|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.061|-0.015|0.2425
71089223|NCT00720499|141684708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005|STANDARD_ERROR_OF_MEAN|0.008||0.5198|TWO_SIDED|95.0|-0.01|0.021|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Day 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.021|-0.010|0.5198
71089224|NCT00720499|141684708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.016||0.211|TWO_SIDED|95.0|-0.011|0.051|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)||0.051|-0.011|0.2110
71089225|NCT00720499|141684708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.014||0.9368|TWO_SIDED|95.0|-0.029|0.027|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)||0.027|-0.029|0.9368
71089226|NCT00720499|141684709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.01||0.5339|TWO_SIDED|95.0|-0.027|0.014|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Day 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)||0.014|-0.027|0.5339
71089227|NCT00720499|141684709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.019||0.2408|TWO_SIDED|95.0|-0.015|0.058|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)||0.058|-0.015|0.2408
71089228|NCT00720499|141684709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.018||0.7139|TWO_SIDED|95.0|-0.029|0.042|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)||0.042|-0.029|0.7139
71089229|NCT00720499|141684710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.015||0.7906|TWO_SIDED|95.0|-0.026|0.034|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.034|-0.026|0.7906
71089230|NCT00720499|141684711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.038||0.8473|TWO_SIDED|95.0|-0.067|0.082|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.082|-0.067|0.8473
71089231|NCT00720499|141684712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032|STANDARD_ERROR_OF_MEAN|0.031||0.2944|TWO_SIDED|95.0|-0.029|0.094|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.094|-0.029|0.2944
71089232|NCT00720499|141684712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.028||0.718|TWO_SIDED|95.0|-0.046|0.066|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.066|-0.046|0.7180
71089233|NCT00720499|141684714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.015||0.9384|TWO_SIDED|95.0|-0.029|0.032|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)||0.032|-0.029|0.9384
71089234|NCT00720499|141684714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|STANDARD_ERROR_OF_MEAN|0.026||0.1583|TWO_SIDED|95.0|-0.014|0.088|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.088|-0.014|0.1583
71089235|NCT00720499|141684714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.029|STANDARD_ERROR_OF_MEAN|0.027||0.2914|TWO_SIDED|95.0|-0.025|0.082|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.082|-0.025|0.2914
71089236|NCT00720499|141684715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.03||0.2485|TWO_SIDED|95.0|-0.024|0.094|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.094|-0.024|0.2485
71089237|NCT00720499|141684716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.043||0.2875|TWO_SIDED|95.0|-0.039|0.13|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.130|-0.039|0.2875
71089238|NCT00720499|141684717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.984|STANDARD_ERROR_OF_MEAN|2.038||0.6299|TWO_SIDED|95.0|-3.046|5.015|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||5.015|-3.046|0.6299
70857650|NCT02054481|141201291|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.1||||0.0062|TWO_SIDED|95.0|6.0|36.2|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|Week 24||36.2|6.0|0.0062
71089239|NCT00720499|141684717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.311|STANDARD_ERROR_OF_MEAN|3.156||0.0475|TWO_SIDED|95.0|0.07|12.553|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||12.553|0.070|0.0475
71089240|NCT00720499|141684717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.552|STANDARD_ERROR_OF_MEAN|2.67||0.562|TWO_SIDED|95.0|-3.729|6.833|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||6.833|-3.729|0.5620
71089241|NCT00720499|141684718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.179|STANDARD_ERROR_OF_MEAN|2.342||0.9391|TWO_SIDED|95.0|-4.812|4.454|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||4.454|-4.812|0.9391
71089242|NCT00720499|141684718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.48|STANDARD_ERROR_OF_MEAN|3.559||0.0709|TWO_SIDED|95.0|-0.56|13.52|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||13.520|-0.560|0.0709
71089243|NCT00720499|141684718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.099|STANDARD_ERROR_OF_MEAN|3.134||0.3245|TWO_SIDED|95.0|-3.1|9.298|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||9.298|-3.100|0.3245
71089244|NCT00720499|141684719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|4.655||0.8808|TWO_SIDED|95.0|-9.914|8.514|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||8.514|-9.914|0.8808
70857651|NCT02054481|141201292|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.1||||0.0008|TWO_SIDED|95.0|11.3|42.9|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|||42.9|11.3|0.0008
71089245|NCT00720499|141684720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.119|STANDARD_ERROR_OF_MEAN|2.177||0.6081|TWO_SIDED|95.0|-3.19|5.429|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test week 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||5.429|-3.190|0.6081
71089246|NCT00720499|141684720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.339|STANDARD_ERROR_OF_MEAN|2.342||0.5686|TWO_SIDED|95.0|-3.296|5.973|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 2. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||5.973|-3.296|0.5686
71089247|NCT00720499|141684720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.653|STANDARD_ERROR_OF_MEAN|2.294||0.7765|TWO_SIDED|95.0|-3.888|5.194|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 3. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||5.194|-3.888|0.7765
70857652|NCT02054481|141201293|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.1||||0.0706|TWO_SIDED|95.0|-0.8|21.1|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|||21.1|-0.8|0.0706
71089248|NCT00720499|141684720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.654|STANDARD_ERROR_OF_MEAN|2.543||0.5166|TWO_SIDED|95.0|-3.379|6.686|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 4. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||6.686|-3.379|0.5166
71089249|NCT00720499|141684721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.303|STANDARD_ERROR_OF_MEAN|2.585||0.2037|TWO_SIDED|95.0|-1.813|8.418|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||8.418|-1.813|0.2037
71089250|NCT00720499|141684721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.393|STANDARD_ERROR_OF_MEAN|2.738||0.6118|TWO_SIDED|95.0|-4.027|6.813|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 2. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||6.813|-4.027|0.6118
71089251|NCT00720499|141684721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.695|STANDARD_ERROR_OF_MEAN|2.498||0.4988|TWO_SIDED|95.0|-3.251|6.64|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 3. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||6.640|-3.251|0.4988
71089252|NCT00720499|141684721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.039|STANDARD_ERROR_OF_MEAN|2.478||0.6757|TWO_SIDED|95.0|-5.944|3.865|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 4. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||3.865|-5.944|0.6757
71089253|NCT00720499|141684722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.08||0.8901|TWO_SIDED|95.0|-0.147|0.169|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.169|-0.147|0.8901
70946338|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8231|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8231
70946339|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0221|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0221
70946340|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6974|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6974
70946341|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7461|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7461
71126267|NCT02986854|141758866|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.36|||||TWO_SIDED|95.0|-0.96|1.99|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||1.99|-0.96|
71126268|NCT02986854|141758867|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|7.23|||||TWO_SIDED|95.0|2.08|11.23|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||11.23|2.08|
71126269|NCT02986854|141758867|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|8.5|||||TWO_SIDED|95.0|3.28|12.74|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||12.74|3.28|
71126270|NCT02986854|141758867|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|7.86|||||TWO_SIDED|95.0|2.87|10.78|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||10.78|2.87|
71126271|NCT02986854|141758867|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-1.27|||||TWO_SIDED|95.0|-6.1|3.49|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||3.49|-6.10|
71126272|NCT02986854|141758867|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|6.25|||||TWO_SIDED|95.0|-3.04|12.44|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||12.44|-3.04|
71126273|NCT02986854|141758867|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|6.61|||||TWO_SIDED|95.0|-2.71|13.01|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||13.01|-2.71|
71126274|NCT02986854|141758867|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|6.43|||||TWO_SIDED|95.0|-2.66|10.9|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||10.90|-2.66|
71126275|NCT02986854|141758867|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-0.36|||||TWO_SIDED|95.0|-7.27|6.43|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||6.43|-7.27|
70857653|NCT02054481|141201294|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.8||||0.03|TWO_SIDED|95.0|1.9|37.7|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|||37.7|1.9|0.0300
71126276|NCT02986854|141758867|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|41.34|||||TWO_SIDED|95.0|28.85|50.63|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||50.63|28.85|
71126277|NCT02986854|141758867|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|36.88|||||TWO_SIDED|95.0|24.39|46.34|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||46.34|24.39|
71126278|NCT02986854|141758867|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|39.16|||||TWO_SIDED|95.0|27.61|46.33|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||46.33|27.61|
70946342|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1198|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1198
70946343|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8031|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8031
70946344|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8515|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8515
70946345|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1285|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1285
71089254|NCT00720499|141684722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.086||0.1647|TWO_SIDED|95.0|-0.29|0.05|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 2. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.050|-0.290|0.1647
71089255|NCT00720499|141684722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.09||0.9822|TWO_SIDED|95.0|-0.18|0.176|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 3. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.176|-0.180|0.9822
71089256|NCT00720499|141684722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.09||0.6542|TWO_SIDED|95.0|-0.218|0.137|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 4. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.137|-0.218|0.6542
71089257|NCT00720499|141684723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.114|STANDARD_ERROR_OF_MEAN|0.116||0.3269|TWO_SIDED|95.0|-0.342|0.115|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for treatment, centre, patient within centre and period (all effects fixed).||0.115|-0.342|0.3269
71089258|NCT00720499|141684724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.089||0.9557|TWO_SIDED|95.0|-0.181|0.171|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.171|-0.181|0.9557
71089259|NCT00720499|141684724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.08||0.8096|TWO_SIDED|95.0|-0.178|0.14|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.140|-0.178|0.8096
71089260|NCT01296412|141684792|NON_INFERIORITY_OR_EQUIVALENCE|The sitagliptin-based treatment paradigm was to be declared non-inferior to the liraglutide-based treatment paradigm in lowering A1C at Week 26 if the upper bound of 95% confidence intervals of between group difference was less than the non-inferiority margin of 0.4%.|Difference in least squares mean|0.09|||||TWO_SIDED|95.0|-0.05|0.23|||ANCOVA|The ANCOVA model included a term for treatment paradigm and a covariate for baseline value.||||0.23|-0.05|
71089261|NCT01296412|141684793|SUPERIORITY_OR_OTHER||Difference in least squares mean|5.9|||||TWO_SIDED|95.0|0.5|11.4|||ANCOVA|The ANCOVA model included a term for treatment paradigm and a covariate for baseline value.||||11.4|0.5|
71089262|NCT01296412|141684794|SUPERIORITY_OR_OTHER||Difference in percent|-9.5|||||TWO_SIDED|95.0|-17.4|-1.5|||Miettinen & Nurminen|||||-1.5|-17.4|
71089263|NCT01296412|141684795|SUPERIORITY_OR_OTHER||Difference in percent|-4.5|||||TWO_SIDED|95.0|-12.7|3.7|||Miettinen & Nurminen|||||3.7|-12.7|
71089264|NCT02160626|141684809|OTHER|||||||0.0003|||||||ANOVA|||||||0.0003
71089265|NCT02160626|141684809|OTHER|||||||0.0001|||||||ANOVA|||||||.0001
71089266|NCT02160626|141684810|OTHER|||||||0.0001|||||||ANCOVA|||mean change from baseline to Visit 8 PLA will be performed using Analysis of Covariance (ANCOVA) with baseline PLA as the covariate.||||0.0001
71089267|NCT02160626|141684810|OTHER|||||||0.0001|||||||ANCOVA|||mean change from baseline to Visit 8 PLA will be performed using Analysis of Covariance (ANCOVA) with baseline PLA as the covariate.||||0.0001
71089268|NCT02160626|141684811|OTHER|||||||0.0016||||||For all analyses, two-tail alpha will be set to 0.05 with no adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|For all analyses, two-tail alpha will be set to 0.05 with no adjustment for multiple comparisons.||"Secondary efficacy analyses will also be conducted based on the proportion of subjects who have at least 3 of 4 target lesions judged to be clear on the PLA (PLA=0) at Visit 8.~A separate comparison will be made between each active treatment group and the vehicle treatment group using Cochran-Mantel-Haenszel (CMH) tests stratified by site."||||0.0016
71089269|NCT02160626|141684811|OTHER|For all analyses, two-tail alpha will be set to 0.05 with no adjustment for multiple comparisons.||||||0.0004||||||For all analyses, two-tail alpha will be set to 0.05 with no adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.0004
71089270|NCT01949545|141684838|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|144.43||||0.02232|TWO_SIDED|95.0|111.48|187.12|||ANOVA||The geometric mean ratio was calculated by exponentiation of the differences in the least squares means, using log-transformed data, between the hepatic impairment cohort (test) and participants with normal hepatic function (reference).|To assess the effect of hepatic impairment relative to participants with normal hepatic function on AUC0-last an analysis of variance (ANOVA) of the log-transformed plasma PK parameters was performed. The ANOVA model included hepatic impairment as a fixed effect.||187.12|111.48|0.02232
71126279|NCT02986854|141758867|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|4.46|||||TWO_SIDED|95.0|-7.04|15.83|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||15.83|-7.04|
71126280|NCT02986854|141758867|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|31.61|||||TWO_SIDED|95.0|22.68|41.79|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||41.79|22.68|
70946346|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5561|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5561
70946347|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6858|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6858
70946348|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0693|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0693
71089271|NCT01949545|141684838|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|126.08||||0.1812|TWO_SIDED|95.0|94.59|168.06|||ANOVA||The geometric mean ratio was calculated by exponentiation of the differences in the least squares means, using log-transformed data, between the hepatic impairment cohort (test) and participants with normal hepatic function (reference).|To assess the effect of hepatic impairment relative to participants with normal hepatic function on AUC0-last an ANOVA of the log-transformed plasma PK parameters was performed. The ANOVA model included hepatic impairment as a fixed effect.||168.06|94.59|0.1812
71089272|NCT01949545|141684839|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|151.84||||0.02137|TWO_SIDED|95.0|113.59|202.96|||ANOVA||The geometric mean ratio was calculated by exponentiation of the differences in the least squares means, using log-transformed data, between the hepatic impairment cohort (test) and participants with normal hepatic function (reference).|To assess the effect of hepatic impairment relative to participants with normal hepatic function on AUC0-inf an ANOVA of the log-transformed plasma PK parameters was performed. The ANOVA model included hepatic impairment as a fixed effect.||202.96|113.59|0.02137
70946349|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5547|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5547
70857654|NCT02054481|141201296|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.2||||0.0072|TWO_SIDED|95.0|5.7|36.6|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|||36.6|5.7|0.0072
70857655|NCT02054481|141201297|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.1844|||<|0.0001|TWO_SIDED|95.0|0.1|0.4|||Log Rank|||||0.4|0.1|<0.0001
70857656|NCT02320903|141201309|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?|||||||||||||Paired samples T test (change over time)|||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was 0.16.|||
70857657|NCT02320903|141201309|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?|||||||||||||Paired samples T test (change over time)|||Paired sample T tests were used to measure change over time for teens.|Cohen's d for youth report was d = 0.22.|||
70857658|NCT02320903|141201310|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?|||||||||||||Paired samples T test (change over time)|||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.22.|||
70857659|NCT02320903|141201310|OTHER|What was the within-group change over time effect size?||||||||||||||||Paired sample T tests were used to measure change for teens over time.|Cohen's d for teen report on this measure was d = 0.22.|||
70857660|NCT02320903|141201311|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?|||||||||||||Paired samples T test (change over time)|||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.10.|||
70857661|NCT02320903|141201311|EQUIVALENCE|What was the within-group change over time effect size? (Cohen's d)||||||||||||||||Paired samples T tests were used to measure change over time for teens.|Cohen's d for youth report was d = 0.28.|||
70857662|NCT02320903|141201312|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?|||||||||||||Paired samples T test (change over time)|||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.16.|||
70857663|NCT02320903|141201312|EQUIVALENCE|What was the within-group change over time effect size? (Cohen's d)||||||||||||||||Paired sample T tests were used to measure change for teens over time.|Cohen's d for youth report was d = 0.21.|||
70857664|NCT02320903|141201313|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?|||||||||||||Paired samples T test (change over time)|||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.62.|||
71126281|NCT02986854|141758867|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|30.85|||||TWO_SIDED|95.0|21.85|41.08|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||41.08|21.85|
71126282|NCT02986854|141758867|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|31.24|||||TWO_SIDED|95.0|22.39|41.38|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||41.38|22.39|
71126283|NCT02986854|141758867|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.76|||||TWO_SIDED|95.0|-1.81|3.52|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||3.52|-1.81|
71126284|NCT02986854|141758868|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|30.02|||||TWO_SIDED|95.0|19.55|38.83|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||38.83|19.55|
71126285|NCT02986854|141758868|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|20.87|||||TWO_SIDED|95.0|10.48|29.69|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||29.69|10.48|
70857665|NCT02320903|141201313|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change over time for teens.|Cohen's d for youth report was d = 0.23.|||
70857666|NCT02320903|141201314|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.22.|||
70857667|NCT02320903|141201314|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired samples T tests were used to measure within-groups change over time for teens.|Cohen's d for youth report was d = 0.26.|||
70857668|NCT02320903|141201315|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d =.12.|||
70857669|NCT02320903|141201316|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.81.|||
70857670|NCT02320903|141201317|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.43.|||
70857671|NCT02320903|141201318|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for teens over time.|Cohen's d for youth report on this measure was d = 24.|||
70857672|NCT03493815|141201342|SUPERIORITY||Risk Ratio (RR)|0.73||||0.51|TWO_SIDED|95.0|0.28|1.9|||binary regression w/ comp log-log link||Ultrasound guided is the numerator and traditional is the denominator.|||1.90|0.28|0.51
70946350|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.461|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4610
70857673|NCT03493815|141201343|SUPERIORITY||Risk Ratio (RR)|0.58||||0.41|TWO_SIDED|95.0|0.15|2.18|||binary regression w/ comp log-log link||Ultrasound guided is the numerator and traditional is the denominator.|||2.18|0.15|0.41
71126286|NCT02986854|141758868|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|25.5|||||TWO_SIDED|95.0|15.79|33.21|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||33.21|15.79|
71126287|NCT02986854|141758868|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|9.14|||||TWO_SIDED|95.0|1.01|17.16|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||17.16|1.01|
71126288|NCT02986854|141758868|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|25.0|||||TWO_SIDED|95.0|8.82|38.9|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||38.90|8.82|
71126289|NCT02986854|141758868|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|15.76|||||TWO_SIDED|95.0|-0.44|29.86|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||29.86|-0.44|
71126290|NCT02986854|141758868|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|20.48|||||TWO_SIDED|95.0|5.32|33.08|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||33.08|5.32|
71126291|NCT02986854|141758868|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|9.24|||||TWO_SIDED|95.0|-2.45|20.68|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||20.68|-2.45|
71126292|NCT02986854|141758868|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|50.25|||||TWO_SIDED|95.0|34.09|63.67|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||63.67|34.09|
71126293|NCT02986854|141758868|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|49.48|||||TWO_SIDED|95.0|33.21|63.01|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||63.01|33.21|
71126294|NCT02986854|141758868|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|49.87|||||TWO_SIDED|95.0|34.42|62.6|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||62.60|34.42|
71126295|NCT02986854|141758868|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.77|||||TWO_SIDED|95.0|-8.3|9.92|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||9.92|-8.30|
71126296|NCT02986854|141758868|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|29.76|||||TWO_SIDED|95.0|21.34|39.75|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||39.75|21.34|
71126297|NCT02986854|141758868|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|29.75|||||TWO_SIDED|95.0|21.32|39.74|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||39.74|21.32|
71126298|NCT02986854|141758868|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|29.76|||||TWO_SIDED|95.0|21.35|39.73|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||39.73|21.35|
71126299|NCT02986854|141758868|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.01|||||TWO_SIDED|95.0|-1.6|1.67|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||1.67|-1.60|
71126300|NCT02986854|141758869|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|17.36|||||TWO_SIDED|95.0|5.85|28.67|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||28.67|5.85|
71126301|NCT02986854|141758869|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|17.92|||||TWO_SIDED|95.0|6.39|29.25|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||29.25|6.39|
71126302|NCT02986854|141758869|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|17.64|||||TWO_SIDED|95.0|6.85|28.28|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||28.28|6.85|
71126303|NCT02986854|141758869|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-0.57|||||TWO_SIDED|95.0|-8.32|7.2|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||7.20|-8.32|
70857674|NCT03493815|141201344|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||||||0.76
71126304|NCT02986854|141758869|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|14.58|||||TWO_SIDED|95.0|-0.98|30.38|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||30.38|-0.98|
71126305|NCT02986854|141758869|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|22.64|||||TWO_SIDED|95.0|7.3|38.16|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||38.16|7.30|
71126306|NCT02986854|141758869|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|18.53|||||TWO_SIDED|95.0|4.14|33.37|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||33.37|4.14|
71126307|NCT02986854|141758869|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-8.06|||||TWO_SIDED|95.0|-18.34|2.38|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||2.38|-18.34|
71126308|NCT02986854|141758869|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|39.04|||||TWO_SIDED|95.0|23.76|54.07|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||54.07|23.76|
71126309|NCT02986854|141758869|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|42.14|||||TWO_SIDED|95.0|27.08|56.98|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||56.98|27.08|
71126310|NCT02986854|141758869|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|40.56|||||TWO_SIDED|95.0|25.91|55.15|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||55.15|25.91|
71126311|NCT02986854|141758869|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-3.1|||||TWO_SIDED|95.0|-10.2|3.89|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||3.89|-10.20|
71126312|NCT02986854|141758869|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|19.57|||||TWO_SIDED|95.0|12.74|28.83|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||28.83|12.74|
71126313|NCT02986854|141758869|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|19.57|||||TWO_SIDED|95.0|12.74|28.83|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||28.83|12.74|
71126314|NCT02986854|141758869|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|19.57|||||TWO_SIDED|95.0|12.75|28.83|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||28.83|12.75|
71126315|NCT02986854|141758869|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.0|||||TWO_SIDED|95.0|-1.31|1.35|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||1.35|-1.31|
71126316|NCT02986854|141758870|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|21.82|||||TWO_SIDED|95.0|11.44|30.6|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||30.60|11.44|
71126317|NCT02986854|141758870|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|17.67|||||TWO_SIDED|95.0|7.34|26.43|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||26.43|7.34|
71126318|NCT02986854|141758870|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|19.77|||||TWO_SIDED|95.0|10.09|27.43|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||27.43|10.09|
71126319|NCT02986854|141758870|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|4.15|||||TWO_SIDED|95.0|-3.8|12.04|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||12.04|-3.80|
71126320|NCT02986854|141758870|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|18.33|||||TWO_SIDED|95.0|2.92|30.99|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||30.99|2.92|
71126321|NCT02986854|141758870|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|18.3|||||TWO_SIDED|95.0|2.83|31.06|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||31.06|2.83|
71126322|NCT02986854|141758870|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|18.31|||||TWO_SIDED|95.0|3.83|29.39|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||29.39|3.83|
70857675|NCT03493815|141201345|SUPERIORITY|||||||0.7|||||||Fisher Exact|||||||0.70
70857676|NCT00178503|141201358|SUPERIORITY_OR_OTHER||Linear trend P value|0.0|||=|0.001|||||||ANOVA|||Data were analyzed using SPSS-PC repeated measures one-way analysis of variance (ANOVA), with MPH dosing regimen as the within-subjects variable.||||=.001
70857677|NCT00178503|141201359|SUPERIORITY_OR_OTHER||Linear p|0.005||||0.005|||||||ANOVA|||||||.005
70857678|NCT00178503|141201360|SUPERIORITY_OR_OTHER||Linear p|0.0|||<|0.001||0.0|||||ANOVA|||||||<.001
70857679|NCT02093351|141201363|EQUIVALENCE|If the 90% confidence interval (CI) for the tamoxifen treatment ratio falls within 0.7 to 1.43, olaparib can be considered to have had an effect on tamoxifen exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|1.13|||||TWO_SIDED|90.0|1.06|1.22|||||olaparib + tamoxifen vs. tamoxifen|Analysis of tamoxifen PK parameters.||1.22|1.06|
70857680|NCT02093351|141201364|EQUIVALENCE|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, tamoxifen can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|0.8|||||TWO_SIDED|90.0|0.71|0.9|||||olaparib + tamoxifen vs. olaparib|Analysis of olaparib PK parameters.||0.90|0.71|
71089273|NCT01949545|141684839|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|143.53||||0.07247|TWO_SIDED|95.0|103.28|199.45|||ANOVA||The geometric mean ratio was calculated by exponentiation of the differences in the least squares means, using log-transformed data, between the hepatic impairment cohort (test) and participants with normal hepatic function (reference).|To assess the effect of hepatic impairment relative to participants with normal hepatic function on AUC0-inf an ANOVA of the log-transformed plasma PK parameters was performed. The ANOVA model included hepatic impairment as a fixed effect.||199.45|103.28|0.07247
70946351|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.664|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6640
70946352|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6158|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6158
71089274|NCT01663623|141684903|OTHER||Hazard Ratio (HR)|1.07||||0.884|TWO_SIDED|95.0|0.44|2.59||Cox proportional Hazards (Wald Chi Square)|Cox Proportional Hazards model|Analysis was adjusted for ANCA type, disease stage at induction and induction regimen|Analysis performed using a Cox Proportional Hazards model with covariates treatment group, Actual ANCA type, Actual disease stage at induction and Actual induction regimen.|||2.59|0.44|0.884
71089275|NCT02265510|141684919|OTHER|Descriptive Statistics|||||||||||||||||The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
71089276|NCT02265510|141684920|OTHER||||||||||||||||||Confidence Intervals for ORR were calculated based on the exact method for binomial distributions. There were no comparison between treatment groups.|||
71089277|NCT02265510|141684921|OTHER||||||||||||||||||Confidence Intervals for response were calculated based on the exact method for binomial distributions. There were no comparison between treatment groups.|||
71089278|NCT02265510|141684922|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
71089279|NCT02265510|141684923|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
71089280|NCT02265510|141684924|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
71089281|NCT02265510|141684925|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
71089282|NCT02265510|141684926|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
70857681|NCT02093351|141201365|EQUIVALENCE|If the 90% CI for the anastrozole treatment ratio falls within 0.8 to 1.25, olaparib can be considered to have had little or no effect on anastrozole exposure.|Geometric Least Squares (GLS) Mean Ratio|0.9|||||TWO_SIDED|90.0|0.84|0.97|||||olaparib + anastrozole vs. anastrozole|Analysis of anastrozole PK parameters.||0.97|0.84|
70857682|NCT02093351|141201366|EQUIVALENCE|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, anastrozole can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|0.94|||||TWO_SIDED|90.0|0.84|1.04|||||olaparib + anastrozole vs. olaparib|Analysis of olaparib PK parameters.||1.04|0.84|
70857683|NCT02093351|141201367|EQUIVALENCE|If the 90% CI for the letrozole treatment ratio falls within 0.8 to 1.25, olaparib can be considered to have had little or no effect on letrozole exposure.|GLS Mean Ratio|0.94|||||TWO_SIDED|90.0|0.91|0.98|||||olaparib + letrozole vs. letrozole|Analysis of letrozole PK parameters.||0.98|0.91|
71089283|NCT02265510|141684927|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
71089284|NCT02265510|141684928|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
71089285|NCT02265510|141684929|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
71126323|NCT02986854|141758870|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.03|||||TWO_SIDED|95.0|-11.35|11.39|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||11.39|-11.35|
70857684|NCT02093351|141201368|EQUIVALENCE|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, letrozole can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|1.09|||||TWO_SIDED|90.0|0.99|1.21|||||olaparib + letrozole vs. olaparib|Analysis of olaparib PK parameters||1.21|0.99|
70857685|NCT02093351|141201369|EQUIVALENCE|If the 90% CI for the tamoxifen treatment ratio falls within 0.7 to 1.43, olaparib can be considered to have had an effect on tamoxifen exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|1.16|||||TWO_SIDED|90.0|1.11|1.21|||||olaparib + tamoxifen vs. tamoxifen|Analysis of tamoxifen PK parameters.||1.21|1.11|
71126324|NCT02986854|141758870|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|48.87|||||TWO_SIDED|95.0|32.64|62.38|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||62.38|32.64|
71089286|NCT01004614|141684942|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two formulations was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCt and Cmax fell wholly within (80%, 125%).|ratios of adjusted geometric mean|98.61|||||TWO_SIDED|90.0|93.09|104.46|||||Parameter estimate = ratio (%) (test/reference) of adjusted geometric means.|Natural log transformed AUCt was analyzed using a mixed effects model with sequence, period and formulation as fixed effects and subject within sequence as a random effect. Adjusted mean difference (test - reference) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL \<=µT - µR \<=θU); null hypothesis of inequivalence: (Ho: µT - µR \<θL or µT - µR \>θU).||104.46|93.09|
71089287|NCT01004614|141684942|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two formulations was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCt and Cmax fell wholly within (80%, 125%).|ratios of adjusted geometric mean|101.29|||||TWO_SIDED|90.0|97.28|105.45|||||Parameter estimate = ratio (%) (test/reference) of adjusted geometric means.|Natural log transformed AUCt was analyzed using a mixed effects model with sequence, period and formulation as fixed effects and subject within sequence as a random effect. Adjusted mean difference (test - reference) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL \<=µT - µR \<=θU); null hypothesis of inequivalence: (Ho: µT - µR \<θL or µT - µR \>θU).||105.45|97.28|
71089288|NCT01004614|141684943|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two formulations was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCt and Cmax fell wholly within (80%, 125%).|ratios of adjusted geometric mean|99.3|||||TWO_SIDED|90.0|92.28|106.28||||Parameter estimate = ratio (%) (test/reference) of adjusted geometric means.||Natural log transformed Cmax was analyzed using a mixed effects model with sequence, period and formulation as fixed effects and subject within sequence as a random effect. Adjusted mean difference (test - reference) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL \<=µT - µR \<=θU); null hypothesis of inequivalence: (Ho: µT - µR \<θL or µT - µR \>θU).||106.28|92.28|
71089289|NCT01004614|141684943|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two formulations was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCt and Cmax fell wholly within (80%, 125%).|ratios of adjusted geometric mean|100.84|||||TWO_SIDED|90.0|95.93|106.0||||Parameter estimate = ratio (%) (test/reference) of adjusted geometric means.||Natural log transformed Cmax was analyzed using a mixed effects model with sequence, period and formulation as fixed effects and subject within sequence as a random effect. Adjusted mean difference (test - reference) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL \<=µT - µR \<=θU); null hypothesis of inequivalence: (Ho: µT - µR \<θL or µT - µR \>θU).||106.00|95.93|
71089290|NCT02111083|141684949|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.986|||||TWO_SIDED|90.0|0.965|1.01||||||||1.01|0.965|
71089291|NCT02111083|141684950|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.872|||||TWO_SIDED|90.0|0.828|0.919||||||||0.919|0.828|
71089292|NCT02111083|141684951|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.25|||||TWO_SIDED|90.0|0.0|0.375||||||||0.375|0|
71089293|NCT02111083|141684952|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.986|||||TWO_SIDED|90.0|0.954|1.02||||||||1.02|0.954|
71089294|NCT02111083|141684953|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.95|||||TWO_SIDED|90.0|0.901|1.0||||||||1.00|0.901|
71089295|NCT02111083|141684954|SUPERIORITY_OR_OTHER||Difference of least squares means|0.424|||||TWO_SIDED|90.0|0.164|0.685||||||||0.685|0.164|
71089296|NCT02111083|141684955|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.992|||||TWO_SIDED|90.0|0.975|1.01||||||||1.01|0.975|
71089297|NCT00486044|141684959|SUPERIORITY_OR_OTHER|||||||0.966||95.0|||||Kruskal-Wallis|||||||0.966
71089298|NCT00486044|141684960|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||ANCOVA|||||||0.015
71089299|NCT00486044|141684961|SUPERIORITY_OR_OTHER|||||||0.113||95.0|||||Kruskal-Wallis|||||||0.113
71089300|NCT00486044|141684962|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Kruskal-Wallis|||||||0.210
71089301|NCT02449434|141684964|OTHER|Using the presence or absence of severe erosive wear as the dependent variable, the unadjusted, sex-and-age- adjusted and fully adjusted associations of the included variables with erosive tooth wear were estimated using unconditional binary logistic regression and reported using odds ratios (OR).|Odds Ratio (OR)|2.25|||<|0.05|TWO_SIDED|95.0||||Only results from fully adjusted regression models will be deemed as significant|Regression, Logistic|Unconditional binary logistic regression and reported using odds ratios and 95% confidence intervals||A minimum sample size of 490 participants (245 in each group) was needed. This calculation assumed the proportion of adults with high dietary acid intake (3+ times/day) was 55% among cases and 40% among controls (expected odds ratio of 2.25), case- control ratio of 1-to-1, 90% statistical power and 95% significance level.||||<0.05
71089302|NCT03154086|141685061|OTHER||Ratio|0.8||||0.204|TWO_SIDED|90.0|0.594|1.077|||ANOVA|||||1.077|0.5940|0.204
71089303|NCT03154086|141685062|OTHER||Ratio|0.7325||||0.118|TWO_SIDED|90.0|0.5267|1.019|||ANOVA|||||1.019|0.5267|0.118
71089304|NCT03154086|141685063|OTHER||Ratio|0.6502||||0.157|TWO_SIDED|90.0|0.3876|1.091|||ANOVA|||||1.091|0.3876|0.157
71089305|NCT04465422|141685084|SUPERIORITY||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|0.97|<|0.001|TWO_SIDED|95.0|1.65|5.55|||Mixed Models Analysis|||Statistical Anaiysis 1 is according to Occupational Performance History Interview - II (OPHI-II) total score.||5.55|1.65|<0.001
71089306|NCT04465422|141685084|SUPERIORITY||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|0.53||0.019|TWO_SIDED|95.0|0.23|2.37|||Mixed Models Analysis|||Statistical Analysis 2 is based on Occupational Identity(range 11\~44；higher scores indicates better performance), a sub-domain of OPHI-II. The Occupational Identity scale is designed to measure the degree to which a client has internalized a positive occupational identity (i.e., has values, interests, and confidence; sees self in various occupational roles; has an image of the kind of life desired)||2.37|0.23|0.019
71126325|NCT02986854|141758870|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|48.18|||||TWO_SIDED|95.0|31.87|61.79|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||61.79|31.87|
71126326|NCT02986854|141758870|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|48.53|||||TWO_SIDED|95.0|33.04|61.31|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||61.31|33.04|
71126327|NCT02986854|141758870|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.69|||||TWO_SIDED|95.0|-8.6|10.04|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||10.04|-8.60|
71126328|NCT02986854|141758870|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|35.48|||||TWO_SIDED|95.0|26.5|45.62|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||45.62|26.50|
71126329|NCT02986854|141758870|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|34.06|||||TWO_SIDED|95.0|24.94|44.28|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||44.28|24.94|
71126330|NCT02986854|141758870|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|34.78|||||TWO_SIDED|95.0|25.78|44.93|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||44.93|25.78|
71126331|NCT02986854|141758870|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|1.42|||||TWO_SIDED|95.0|0.1|3.6|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||3.60|0.10|
71126332|NCT02986854|141758871|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|1.39|||||TWO_SIDED|95.0|-6.08|4.94|||Miettinen & Nurminen score method|||Serogroup A- Day 4- Total seroresponse (Menveo-Menveo vs. Naive)||4.94|-6.08|
71126333|NCT02986854|141758871|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|2.17|||||TWO_SIDED|95.0|-5.32|6.21|||Miettinen & Nurminen score method|||Serogroup A- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)||6.21|-5.32|
71126334|NCT02986854|141758871|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|1.77|||||TWO_SIDED|95.0|-5.68|4.09|||Miettinen & Nurminen score method|||Serogroup A- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||4.09|-5.68|
71126335|NCT02986854|141758871|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-0.79|||||TWO_SIDED|95.0|-4.98|3.01|||Miettinen & Nurminen score method|||Serogroup A- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||3.01|-4.98|
71126336|NCT02986854|141758871|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|34.76|||||TWO_SIDED|95.0|22.38|44.07|||Miettinen & Nurminen score method|||Serogroup A- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)||44.07|22.38|
71126337|NCT02986854|141758871|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|26.88|||||TWO_SIDED|95.0|14.67|36.13|||Miettinen & Nurminen score method|||Serogroup A- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)||36.13|14.67|
71126338|NCT02986854|141758871|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|30.89|||||TWO_SIDED|95.0|19.42|37.97|||Miettinen & Nurminen score method|||Serogroup A- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||37.97|19.42|
71126339|NCT02986854|141758871|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|7.88|||||TWO_SIDED|95.0|-3.25|18.81|||Miettinen & Nurminen score method|||Serogroup A- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||18.81|-3.25|
71126340|NCT02986854|141758871|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-3.45|||||TWO_SIDED|95.0|-14.26|2.35|||Miettinen & Nurminen score method|||Serogroup C- Day 4-Total seroresponse- (Menveo-Menveo vs. Naive)||2.35|-14.26|
71126341|NCT02986854|141758871|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|2.51|||||TWO_SIDED|95.0|-8.7|9.98|||Miettinen & Nurminen score method|||Serogroup C- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)||9.98|-8.70|
71126342|NCT02986854|141758871|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-0.54|||||TWO_SIDED|95.0|-11.35|4.9|||Miettinen & Nurminen score method|||Serogroup C- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||4.90|-11.35|
71126343|NCT02986854|141758871|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-5.96|||||TWO_SIDED|95.0|-12.25|-0.57|||Miettinen & Nurminen score method|||Serogroup C- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||-0.57|-12.25|
71126344|NCT02986854|141758871|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|40.03|||||TWO_SIDED|95.0|25.37|50.92|||Miettinen & Nurminen score method|||Serogroup C- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)||50.92|25.37|
71126345|NCT02986854|141758871|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|36.84|||||TWO_SIDED|95.0|22.14|47.9|||Miettinen & Nurminen score method|||Serogroup C- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)||47.90|22.14|
71126346|NCT02986854|141758871|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|38.46|||||TWO_SIDED|95.0|24.79|47.57|||Miettinen & Nurminen score method|||Serogroup C- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||47.57|24.79|
71089307|NCT04465422|141685084|SUPERIORITY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|0.43||0.006|TWO_SIDED|95.0|0.38|2.11|||Mixed Models Analysis|||Statistical Analysis 3 is based on Occupational Competence(range 9\~36；higher scores indicate better performance), a sub-domain of OPHI-II. The Occupational Competence scale is designed to measure the degree to which a client is able to sustain a pattern of occupational behavior that is productive and satisfying.||2.11|0.38|0.006
71089308|NCT04465422|141685084|SUPERIORITY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.38||0.136|TWO_SIDED|95.0|-0.19|1.35|||Mixed Models Analysis|||Statistical Analysis 4 is based on Occupational Behavior Settings(range 9\~36；higher scores indicate greater performance), a sub-domain of OPHI-II. The Occupational Behavior Settings scale addresses the impact of the environment on the person's occupational life.||1.35|-0.19|0.136
71089309|NCT04465422|141685085|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|1.53||0.592|TWO_SIDED|95.0|-3.9|2.25|||Mixed Models Analysis|||Statistical Analysis 1 is based on Lawton Instrumental Activities Daily Living (range 0\~23；the higher scores indicate greater performance) total scores.||2.25|-3.90|0.592
71089310|NCT04465422|141685085|SUPERIORITY||Mean Difference (Final Values)|4.1|STANDARD_ERROR_OF_MEAN|2.37||0.302|TWO_SIDED|95.0|-2.29|7.23|||Mixed Models Analysis|||Statistical Analysis 2 is based on Comprehensive Occupational Therapy Evaluation Scale (range 20\~100；the higher scores indicate greater performance) total scores.||7.23|-2.29|0.302
71089311|NCT04465422|141685085|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|3.25||0.931|TWO_SIDED|95.0|-6.25|6.82|||Mixed Models Analysis|||Statistical Analysis 3 is based on Personal and Social Performance scale (range 1\~100；the higher scores indicate greater performance) total scores.||6.82|-6.25|0.931
71089312|NCT04465422|141685085|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.85||0.981|TWO_SIDED|95.0|-1.73|1.69|||Mixed Models Analysis|||Statistical Analysis 4 is based on Canadian Occupational Performance Measure (range 1\~10；the higher scores indicate greater performance) total scores.||1.69|-1.73|0.981
71089313|NCT00572832|141685118|NON_INFERIORITY_OR_EQUIVALENCE|The formula used for calculating sample size for the treatment arm (NT) is NT = (1 + 1/u) (Zα + Zβ)2 σ2 /\[log (RGMC) -δ0\] where u is the ratio of the size of the control and treatment arms, one sided alpha that is divided by 4, a non-inferiority margin (δ0 of natural log 0.5), the expected ratio of geometric mean concentrations RGMC set at 0.8, and a standard deviation of 1.26 (the largest for HPV-16). The calculated sample size for a power of 80% was 75 participants in each arm.||||||0.025||95.0||||Non-inferiority was tested against a one-sided null hypothesis (alpha=.025) that the post Dose 3 GMT ratio of the Alternate to Standard schedule was ≤ 0.5 for each HPV type. Results: GMT ratios were 2.23, 3,17, 2.14, and 1.68 for types 6,11,16,\& 18.|ANOVA|Log transformed the data and calculated GMTs. Tested if post Dose 3 GMT ratio of the Alternate to Standard schedule was ≤ 0.5 for each HPV type||Non-inferiority tested against 1-sided null hypothesis (alpha=.025) that the post Dose 3 GMT ratio of the Alternate to Standard schedule was ≤ 0.5 for each HPV type||||.025
71089314|NCT00966433|141685119|OTHER||Mean Difference (Final Values)|-8.2||||0.0051|TWO_SIDED|95.0|-13.61|-2.79|||t-test, 2 sided|||||-2.79|-13.61|.0051
71089315|NCT00966433|141685120|OTHER||Mean Difference (Final Values)|3.6||||0.0001|TWO_SIDED|95.0|2.97|4.23|||t-test, 2 sided|||||4.23|2.97|.0001
71089316|NCT00966433|141685125|OTHER||Mean Difference (Final Values)|-13.9||||0.0001|TWO_SIDED|95.0|-18.88|-8.92|||t-test, 2 sided|||||-8.92|-18.88|.0001
71089317|NCT01258049|141685128|SUPERIORITY_OR_OTHER||Percentage Difference|54.85|||<|0.005|TWO_SIDED|95.0|42.25|67.45|||Regression, Logistic|||In ART003, the parasite success rate for quinine was 67.7%. On the assumption that the parasite success rate was 70% for quinine in this study and in order to demonstrate that ArTiMist™ is superior to quinine by at least 20% the success rate for ArTiMist™ should be at least 90%. Using these figures, and assuming a power of 80%, an alpha of 0.05 (two sided) and based on an equal allocation to the ArTiMist™ and quinine treatment arms, the number of subjects (n) required on each treatment was 59.||67.45|42.25|<0.005
71089318|NCT01258049|141685129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-38.97|||<|0.05|TWO_SIDED|95.0|-62.22|-15.72|||ANCOVA|||||-15.72|-62.22|<0.05
71089319|NCT01258049|141685130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.91|||<|0.005|TWO_SIDED|95.0|-17.38|-8.44|||ANCOVA|||||-8.44|-17.38|<0.005
71089320|NCT01258049|141685131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.16|||<|0.005|TWO_SIDED|95.0|-11.71||||Regression, Cox|||||- 6.61|-11.71|<0.005
71089321|NCT01258049|141685132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|54.02|||<|0.005|TWO_SIDED|95.0|27.05|80.98|||ANCOVA|||||80.98|27.05|<0.005
71089322|NCT01258049|141685133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|174.09||||0.06|TWO_SIDED|95.0|-10.44|358.61|||ANCOVA||mean parasite counts increased in the first 12 hours for patients on quinine treatment|||358.61|-10.44|0.06
71089323|NCT01258049|141685134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96||||0.86|TWO_SIDED|95.0|-10.16|12.08|||Regression, Cox|||||12.08|-10.16|0.86
71089324|NCT01258049|141685135|SUPERIORITY_OR_OTHER||Percentage Difference|0.99||||0.99|TWO_SIDED|95.0|0.42|2.36|||Regression, Logistic|||||2.36|0.42|0.99
71089325|NCT01258049|141685138|SUPERIORITY_OR_OTHER||Percentage Difference|55.01|||<|0.005|TWO_SIDED|95.0|42.44|67.58|||Regression, Linear|||||67.58|42.44|<0.005
71089326|NCT03444584|141685144|SUPERIORITY||LS mean difference|-143.09|||<|0.0001|TWO_SIDED|95.0|-198.2|-87.98|||ANCOVA|||||-87.98|-198.20|<0.0001
70946353|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1632|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1632
70946354|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.177|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1770
71126347|NCT02986854|141758871|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|3.19|||||TWO_SIDED|95.0|-8.44|14.73|||Miettinen & Nurminen score method|||Serogroup C- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||14.73|-8.44|
71126348|NCT02986854|141758871|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-3.47|||||TWO_SIDED|95.0|-14.28|2.31|||Miettinen & Nurminen score method|||Serogroup W- Day 4-Total seroresponse- (Menveo-Menveo vs. Naive)||2.31|-14.28|
71126349|NCT02986854|141758871|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|3.89|||||TWO_SIDED|95.0|-7.4|11.6|||Miettinen & Nurminen score method|||Serogroup W- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)||11.60|-7.40|
71126350|NCT02986854|141758871|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|0.13|||||TWO_SIDED|95.0|-10.7|5.66|||Miettinen & Nurminen score method|||Serogroup W- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||5.66|-10.70|
71126351|NCT02986854|141758871|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-7.37|||||TWO_SIDED|95.0|-13.89|-1.8|||Miettinen & Nurminen score method|||Serogroup W- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||-1.80|-13.89|
71126352|NCT02986854|141758871|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|38.98|||||TWO_SIDED|95.0|24.35|49.88|||Miettinen & Nurminen score method|||Serogroup W- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)||49.88|24.35|
70946355|NCT00551135|141392984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4882|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4882
70946356|NCT00551135|141392985|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7936|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7936
71126353|NCT02986854|141758871|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|37.92|||||TWO_SIDED|95.0|23.23|48.95|||Miettinen & Nurminen score method|||Serogroup W- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)||48.95|23.23|
71126354|NCT02986854|141758871|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|38.46|||||TWO_SIDED|95.0|24.8|47.56|||Miettinen & Nurminen score method|||Serogroup W- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||47.56|24.80|
71126355|NCT02986854|141758871|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|1.06|||||TWO_SIDED|95.0|-10.51|12.6|||Miettinen & Nurminen score method|||Serogroup W- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||12.60|-10.51|
71126356|NCT02986854|141758871|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|7.75|||||TWO_SIDED|95.0|0.15|13.36|||Miettinen & Nurminen score method|||Serogroup Y- Day 4-Total seroresponse- (Menveo-Menveo vs. Naive)||13.36|0.15|
71126357|NCT02986854|141758871|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|4.38|||||TWO_SIDED|95.0|-3.15|9.24|||Miettinen & Nurminen score method|||Serogroup Y- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)||9.24|-3.15|
71126358|NCT02986854|141758871|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|6.09|||||TWO_SIDED|95.0|-1.41|9.55|||Miettinen & Nurminen score method|||Serogroup Y- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||9.55|-1.41|
71126359|NCT02986854|141758871|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|3.37|||||TWO_SIDED|95.0|-2.48|9.54|||Miettinen & Nurminen score method|||Serogroup Y- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||9.54|-2.48|
70857686|NCT02093351|141201370|EQUIVALENCE|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, tamoxifen can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|0.73|||||TWO_SIDED|90.0|0.63|0.84|||||olaparib + tamoxifen vs. olaparib|Analysis of olaparib PK parameters.||0.84|0.63|
70857687|NCT02093351|141201371|EQUIVALENCE|If the 90% CI for the anastrozole treatment ratio falls within 0.8 to 1.25, olaparib can be considered to have had little or no effect on anastrozole exposure.|GLS Mean Ratio|0.86|||||TWO_SIDED|90.0|0.8|0.93|||||olaparib + anastrozole vs. anastrozole|Analysis of anastrozole PK parameters.||0.93|0.80|
70857688|NCT02093351|141201372|EQUIVALENCE|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, anastrozole can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|0.89|||||TWO_SIDED|90.0|0.76|1.05|||||olaparib + anastrozole vs. olaparib|Analysis of olaparib PK parameters.||1.05|0.76|
70857689|NCT02093351|141201373|EQUIVALENCE|If the 90% CI for the letrozole treatment ratio falls within 0.8 to 1.25, olaparib can be considered to have had little or no effect on letrozole exposure.|GLS Mean Ratio|0.95|||||TWO_SIDED|90.0|0.91|0.99|||||olaparib + letrozole vs. letrozole|Analysis of letrozole PK parameters.||0.99|0.91|
70857690|NCT02093351|141201374|EQUIVALENCE|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, letrozole can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|1.15|||||TWO_SIDED|90.0|1.07|1.25|||||olaparib + letrozole vs. olaparib|Analysis of olaparib PK parameters.||1.25|1.07|
70857691|NCT01099709|141201375|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|105.0|||||TWO_SIDED|90.0|101.06|108.51|||||Bioequivalence was established when 90% Confidence Interval fell within 80%-125%.|||108.51|101.06|
70857692|NCT01099709|141201375|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|105.0|||||TWO_SIDED|90.0|101.06|108.51|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||108.51|101.06|
70857693|NCT01099709|141201376|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|95.6|||||TWO_SIDED|90.0|93.73|97.53|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||97.53|93.73|
70857694|NCT01099709|141201377|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric test/Ref Ratio x 100|95.7|||||TWO_SIDED|90.0|93.85|97.68|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||97.68|93.85|
70857695|NCT01122394|141201388|SUPERIORITY_OR_OTHER|||||||0.29|||||||robust regression|controlling for provider clustering||Robust regressions were performed||||0.29
70857696|NCT01122394|141201389|SUPERIORITY_OR_OTHER|||||||0.25|||||||Regression, Logistic|This analysis includes participants in pre-action and action/maintenance||||||0.25
70857697|NCT01122394|141201390|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
70857698|NCT01122394|141201391|SUPERIORITY_OR_OTHER|||||||0.81|||||||Regression, Linear|||||||0.81
70857699|NCT01122394|141201392|SUPERIORITY_OR_OTHER|||||||0.12|||||||Regression, Linear|||||||0.12
70857700|NCT00039871|141201393|SUPERIORITY_OR_OTHER||Binomial Approximation|0.217||||||99.0|0.195|0.239||||||||0.239|0.195|
70857701|NCT00039871|141201394|SUPERIORITY_OR_OTHER||Binomial Approximation|0.563||||||95.0|0.529|0.596||||||||0.596|0.529|
70857702|NCT00039871|141201395|SUPERIORITY_OR_OTHER||Binomial Approximation|0.122||||||95.0|0.076|0.169||||||||0.169|0.076|
70857703|NCT01992159|141201430|SUPERIORITY||Treatment Difference|7.5|||<|0.0001|ONE_SIDED|95.0|6.5|||P-values were adjusted for multiplicity using a combination of a sequential test procedure and Hochberg's method to control type 1 error for the primary endpoint.|Repeated Measures Model|||The primary analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||6.5|< 0.0001
70857704|NCT01992159|141201430|SUPERIORITY||Treatment Difference|12.4|||<|0.0001|ONE_SIDED|95.0|11.1|||P-values were adjusted for multiplicity using a combination of a sequential test procedure and Hochberg's method to control type 1 error for the primary endpoint.|Repeated Measures Model|||The primary analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||11.1|< 0.0001
70857705|NCT01992159|141201430|SUPERIORITY||Treatment Difference|16.0|||<|0.0001|ONE_SIDED|95.0|14.6|||One-sided p-values were adjusted for multiplicity using a combination of a sequential test procedure and Hochberg's method to control type 1 error for the primary endpoint.|Repeated Measures Model|||The primary analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||14.6|< 0.0001
70857706|NCT01992159|141201431|SUPERIORITY||Treatment Difference|5.3|||<|0.0001|ONE_SIDED|95.0|4.4||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||4.4|< 0.0001
70946357|NCT00551135|141392985|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5092|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5092
71089327|NCT03444584|141685145|SUPERIORITY||LS mean difference|-22.17|||<|0.0001|TWO_SIDED|95.0|-30.24|-14.1|||ANCOVA|||||-14.10|-30.24|<0.0001
71089328|NCT01142336|141685173|SUPERIORITY|||||||0.53||||||Threshold for significance: 0.05, adjust for 3 primary outcomes using Holm Correction|ANCOVA|Response variable was Aβ42 in CSF at 1 year, and predictor variables were Aβ42 in CSF at baseline, treatment group, age, sex, and APOE e4 allele.||||||0.53
71089329|NCT01142336|141685174|SUPERIORITY|||||||0.36||||||Threshold for significance: 0.05, adjusted for 3 primary outcomes using Holm correction|ANCOVA|Response variable was total tau in CSF at 1 year, and predictor were total tau in at baseline, treatment group, age, sex, and APOE e4 allele status||||||0.36
71089330|NCT01142336|141685175|SUPERIORITY|||||||0.25||||||Threshold for significance: 0.05, adjusted for 3 primary outcomes using Holm correction.|ANCOVA|Response variable was p-tau181 in CSF at 1 year, and predictor were p-tau181 in at baseline, treatment group, age, sex, and APOE e4 allele status||||||0.25
71089331|NCT01704261|141685176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|||<|0.001|TWO_SIDED|95.0|-0.85|-0.38|||Difference in the least squares means|Based on a constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups.||||-0.38|-0.85|<0.001
70857707|NCT01992159|141201431|SUPERIORITY||Treatment Difference|9.0|||<|0.0001|ONE_SIDED|95.0|8.0||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||8.0|< 0.0001
70857708|NCT01992159|141201431|SUPERIORITY||Treatment Difference|11.9|||<|0.0001|ONE_SIDED|95.0|10.6||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||10.6|< 0.0001
70857709|NCT01992159|141201432|SUPERIORITY||Treatment Difference|0.6||||0.125|ONE_SIDED|95.0|-0.3||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||-0.3|0.1250
70946358|NCT00551135|141392985|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4233|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4233
70857710|NCT01992159|141201432|SUPERIORITY||Treatment Difference|1.7||||0.0002|ONE_SIDED|95.0|0.9||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||0.9|0.0002
71089332|NCT01704261|141685177|SUPERIORITY_OR_OTHER||Difference in % Omarigliptin vs Placebo|9.8|||||TWO_SIDED|95.0|-1.4|20.8||||||||20.8|-1.4|
71089333|NCT01704261|141685178|SUPERIORITY_OR_OTHER||Difference in % Omarigliptin vs Placebo|0.0|||||TWO_SIDED|95.0|-4.3|4.3||||||||4.3|-4.3|
70857711|NCT01992159|141201432|SUPERIORITY||Treatment Difference|2.6|||<|0.0001|ONE_SIDED|95.0|1.7||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||1.7|< 0.0001
70857712|NCT01992159|141201433|SUPERIORITY||Treatment Difference|1.5||||0.0012|ONE_SIDED|95.0|0.7||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||0.7|0.0012
70857713|NCT01992159|141201433|SUPERIORITY||Treatment Difference|2.6|||<|0.0001|ONE_SIDED|95.0|1.8||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||1.8|< 0.0001
71089334|NCT01704261|141685179|SUPERIORITY_OR_OTHER||Difference of the least squares means|-16.6|||<|0.001|TWO_SIDED|95.0|-25.5|-7.8|||Difference in the least squares means|Based on a constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups.||||-7.8|-25.5|<0.001
70946359|NCT00551135|141392985|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2033|TWO_SIDED||||||ANOVA|||Change at EOT; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2033
70946360|NCT00551135|141392985|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2142|TWO_SIDED||||||ANOVA|||Change at EOT; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2142
70946361|NCT00551135|141392985|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1218|TWO_SIDED||||||ANOVA|||Change at EOT; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1218
70946362|NCT00551135|141392986|SUPERIORITY_OR_OTHER_LEGACY|||||||0.083|TWO_SIDED||||||ANOVA|||Total score change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0830
70946363|NCT00551135|141392986|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2339|TWO_SIDED||||||ANOVA|||Total score change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2339
70946364|NCT00551135|141392986|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0629|TWO_SIDED||||||ANOVA|||Total score change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0629
70946365|NCT00551135|141392986|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5721|TWO_SIDED||||||ANOVA|||Total score change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5721
70946366|NCT00551135|141392986|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9713|TWO_SIDED||||||ANOVA|||Total score change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9713
71089335|NCT01704261|141685180|SUPERIORITY_OR_OTHER||Between-group Rate Difference|19.3|||<|0.001|TWO_SIDED|95.0|11.7|27.6|||Miettinen & Nurminen method|Between-group confidence intervals and p-value (%) A1C \<7.0%; estimated using standard multiple imputation techniques.||||27.6|11.7|<0.001
71089336|NCT01704261|141685180|SUPERIORITY_OR_OTHER||Between-group Rate Difference (%)|8.0||||0.005|TWO_SIDED|95.0|2.7|14.5|||Miettinen & Nurminen method|Between-group confidence intervals and p-value (%) A1C \<7.0%; estimated using standard multiple imputation techniques.||||14.5|2.7|0.005
71126360|NCT02986854|141758871|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|39.86|||||TWO_SIDED|95.0|25.76|50.29|||Miettinen & Nurminen score method|||Serogroup Y- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)||50.29|25.76|
70857714|NCT01992159|141201433|SUPERIORITY||Treatment Difference|4.1|||<|0.0001|ONE_SIDED|95.0|3.3||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||3.3|< 0.0001
70946367|NCT00551135|141392986|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4809|TWO_SIDED||||||ANOVA|||Total score change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4809
70946368|NCT00551135|141392986|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1561|TWO_SIDED||||||ANOVA|||Rumination change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1561
70946369|NCT00551135|141392986|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5267|TWO_SIDED||||||ANOVA|||Rumination change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5267
70946370|NCT00551135|141392986|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1125|TWO_SIDED||||||ANOVA|||Rumination change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1125
70946371|NCT00551135|141392986|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2965|TWO_SIDED||||||ANOVA|||Rumination change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2965
70946372|NCT00551135|141392986|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7774|TWO_SIDED||||||ANOVA|||Rumination change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7774
70946373|NCT00551135|141392986|SUPERIORITY_OR_OTHER_LEGACY|||||||0.399|TWO_SIDED||||||ANOVA|||Rumination change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3990
71089337|NCT03704064|141685202|SUPERIORITY||Mean Difference (Net)|-1.97|STANDARD_ERROR_OF_MEAN|1.32||0.14|TWO_SIDED||||||Mixed Models Analysis|||||||0.14
71089338|NCT03704064|141685203|SUPERIORITY||Odds Ratio (OR)|1.1||||0.89|TWO_SIDED|95.0|0.4|3.4|||Mixed Models Analysis|||||3.4|0.4|0.89
70857715|NCT01992159|141201434|SUPERIORITY||Treatment Difference|0.3||||0.2846|ONE_SIDED|95.0|-0.6||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||-0.6|0.2846
70857716|NCT01992159|141201434|SUPERIORITY||Treatment Difference|1.3||||0.0151|ONE_SIDED|95.0|0.3||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||0.3|0.0151
70857717|NCT01992159|141201434|SUPERIORITY||Treatment Difference|2.6||||0.0001|ONE_SIDED|95.0|1.5||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||1.5|0.0001
70857718|NCT01992159|141201435|SUPERIORITY||Treatment Difference|1.6||||0.0067|ONE_SIDED|95.0|0.5||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||0.5|0.0067
70857719|NCT01992159|141201435|SUPERIORITY||Treatment Difference|2.6|||<|0.0001|ONE_SIDED|95.0|1.6||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||1.6|< 0.0001
70857720|NCT01992159|141201435|SUPERIORITY||Treatment Difference|3.5|||<|0.0001|ONE_SIDED|95.0|2.3||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||2.3|< 0.0001
70857721|NCT01992159|141201440|SUPERIORITY||Treatment Difference|-15.3||||0.5084|TWO_SIDED|95.0|-60.8|30.2|||ANCOVA|ANCOVA model with the AUC of P1NP at month 12 as the dependent variable, and baseline P1NP and treatment (categorical) as the independent variables.||||30.2|-60.8|0.5084
70857722|NCT01992159|141201440|SUPERIORITY||Treatment Difference|84.1||||0.0002|TWO_SIDED|95.0|40.1|128.0|||ANCOVA|ANCOVA model with the AUC of P1NP at month 12 as the dependent variable, and baseline P1NP and treatment (categorical) as the independent variables.||||128.0|40.1|0.0002
70857723|NCT01992159|141201440|SUPERIORITY||Treatment Difference|153.8|||<|0.0001|TWO_SIDED|95.0|109.2|198.4|||ANCOVA|ANCOVA model with the AUC of P1NP at months 12 as the dependent variable, and baseline P1NP and treatment (categorical) as the independent variables.||||198.4|109.2|< 0.0001
70857724|NCT01198158|141201441|SUPERIORITY|||||||0.739|||||||Log Rank|OS was analyzed based on an intent-to-treat approach using the stratified log-rank statistic adjusting on the stratification factors.||||||0.739
70857725|NCT01198158|141201442|SUPERIORITY|||||||0.832|||||||Log Rank|PFS was analyzed based on an intent-to-treat approach using the stratified log-rank statistic adjusting on the stratification factors||||||0.832
70857726|NCT05033002|141201483|SUPERIORITY||Slope|-0.41|||<|0.0001|TWO_SIDED|||||The p-value is for the t-test of the coefficient of linear (TimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of linear (TimeXGroup) trends. Controlled for significant covariates.|||||<.0001
70857727|NCT05033002|141201483|SUPERIORITY||Slope|0.002|||<|0.0001|TWO_SIDED|||||The p-value is for the t-test of the coefficient of quadratic (TimeXTimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of quadratic (TimeXTimeXGroup) trends. Controlled for significant covariates.|||||<.0001
70857728|NCT05033002|141201484|SUPERIORITY||Slope|0.06||||0.002|TWO_SIDED|||||The p-value is for the t-test of the coefficient of linear (TimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of linear (TimeXGroup) trends. Controlled for significant covariates.|||||.002
70857729|NCT05033002|141201484|SUPERIORITY||Slope|-0.0003||||0.01|TWO_SIDED|||||The p-value is for the t-test of the coefficient of quadratic (TimeXTimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of quadratic (TimeXTimeXGroup) trends. Controlled for significant covariates.|||||.010
70857730|NCT05033002|141201485|SUPERIORITY||Slope|0.05||||0.001|TWO_SIDED|||||The p-value is for the t-test of the coefficient of linear (TimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of linear (TimeXGroup) trends. Controlled for significant covariates.|||||.001
70857731|NCT05033002|141201485|SUPERIORITY||Slope|-0.0002||||0.032|TWO_SIDED|||||The p-value is for the t-test of the coefficient of quadratic (TimeXTimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of quadratic (TimeXTimeXGroup) trends. Controlled for significant covariates.|||||.032
70857732|NCT05033002|141201486|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.506|TWO_SIDED||||||t-test, 2 sided|||||||0.506
71089339|NCT03704064|141685204|SUPERIORITY||Odds Ratio (OR)|3.7||||0.06|TWO_SIDED|95.0|1.0|14.7|||Mixed Models Analysis|||||14.7|1.0|0.06
70857733|NCT05033002|141201487|SUPERIORITY|||||||0.441||||||The p-value is for the t-test of the coefficient of linear (TimeXGroup) trends.|Mixed Models Analysis|The estimated value is for the slope of linear (TimeXGroup) trends. Controlled for significant covariates.||||||.441
70857734|NCT05033002|141201487|SUPERIORITY||Slope|0.0002||||0.734|TWO_SIDED|||||The p-value is for the t-test of the coefficient of quadratic (TimeXTimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of quadratic (TimeXTimeXGroup) trends. Controlled for significant covariates.|||||.734
70857735|NCT04972630|141201498|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0||||||||Baseline control vs. intervention||||
70857736|NCT04972630|141201498|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0||||||||Week 4 control vs. intervention||||
71089340|NCT03704064|141685205|SUPERIORITY||Mean Difference (Net)|-2.4|STANDARD_ERROR_OF_MEAN|1.3||0.07|TWO_SIDED||||||Mixed Models Analysis|||||||0.07
71089341|NCT03704064|141685206|SUPERIORITY||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|1.3||0.42|TWO_SIDED||||||Mixed Models Analysis|||||||0.42
71089342|NCT03704064|141685207|SUPERIORITY||Odds Ratio (OR)|2.0||||0.24|TWO_SIDED|95.0|0.6|6.3|||Mixed Models Analysis|||||6.3|0.6|0.24
70857737|NCT04972630|141201498|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0||||||||Week 12, control vs. intervention||||
70857738|NCT04972630|141201498|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0||||||||Week 24, control vs. intervention||||
70857739|NCT04972630|141201499|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0||||||||||||
70857740|NCT04972630|141201500|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|1.5|||||TWO_SIDED|95.0||||||||||||
70857741|NCT04972630|141201501|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-1.7|||||TWO_SIDED|95.0||||||||||||
71126361|NCT02986854|141758871|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|48.05|||||TWO_SIDED|95.0|33.89|58.34|||Miettinen & Nurminen score method|||Serogroup Y- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)||58.34|33.89|
70857742|NCT04972630|141201502|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-2.8|||||TWO_SIDED|95.0||||||||||||
70857743|NCT04972630|141201503|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-9.2|||||TWO_SIDED|95.0||||||||||||
70857744|NCT04972630|141201504|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|3.2|||||TWO_SIDED|95.0||||||||||||
71126362|NCT02986854|141758871|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|43.91|||||TWO_SIDED|95.0|30.79|52.37|||Miettinen & Nurminen score method|||Serogroup Y- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||52.37|30.79|
71126363|NCT02986854|141758871|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-8.19|||||TWO_SIDED|95.0|-19.61|3.45|||Miettinen & Nurminen score method|||Serogroup Y- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||3.45|-19.61|
71126364|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.26|||||TWO_SIDED|95.0|0.93|1.7||||||Serogroup A-Vaccine comparison at day 4(Menveo-Menveo vs. Naive)||1.70|0.93|
71126365|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.34|||||TWO_SIDED|95.0|0.98|1.82||||||Serogroup A-Vaccine comparison at day 4(Menactra-Menveo vs. Naive)||1.82|0.98|
70857745|NCT04972630|141201505|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-5.0|||||TWO_SIDED|95.0||||||||||||
70857746|NCT04972630|141201506|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-4.5|||||TWO_SIDED|95.0||||||||||||
70857747|NCT04972630|141201507|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-6.4|||||TWO_SIDED|95.0||||||||||||
70857748|NCT04972630|141201508|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-3.8|||||TWO_SIDED|95.0||||||||||||
70857749|NCT04972630|141201509|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-16.7|||||TWO_SIDED|95.0||||||||||||
70857750|NCT04972630|141201510|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0||||||||||||
70857751|NCT04972630|141201511|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0||||||||Baseline, control vs. intervention||||
70857752|NCT04972630|141201511|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|5.5|||||TWO_SIDED|95.0||||||||Week 4, control vs. intervention||||
70857753|NCT04972630|141201511|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0||||||||Week 12, control vs. intervention||||
70857754|NCT04972630|141201511|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|2.6|||||TWO_SIDED|95.0||||||||Week 24, control vs. intervention||||
70857755|NCT04972630|141201512|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-2.2|||||TWO_SIDED|95.0||||||||Baseline, control vs. intervention||||
70857756|NCT04972630|141201512|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0||||||||Week 4, control vs. intervention||||
70857757|NCT04972630|141201512|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0||||||||Week 12, control vs. intervention||||
70857758|NCT04972630|141201512|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0||||||||Week 24, control vs. intervention||||
70857759|NCT03390842|141201520|SUPERIORITY||Difference in % of subjects|24.9|||=|0.0015|TWO_SIDED|95.0|10.2|38.7|||Fisher Exact|||% Subjects Who Met Endpoint (≥ 4 mEq/L Change from Baseline Serum Bicarbonate or Serum Bicarbonate in the Normal Range \[22 - 29 mEq/L\]): TRC101-Placebo||38.7|10.2|= 0.0015
70857760|NCT03390842|141201520|SUPERIORITY||Treatment difference in % of subjects|24.4|||=|0.0015|TWO_SIDED|95.0|9.7|38.2|||Fisher Exact|||% Subjects with ≥ 4mEq/L Change from Baseline in Serum Bicarbonate: TRC101-Placebo||38.2|9.7|= 0.0015
70857761|NCT03390842|141201520|SUPERIORITY||Treatment difference in % of subjects|30.2|||<|0.0001|TWO_SIDED|95.0|15.6|43.7|||Fisher Exact|||% Subjects with Serum Bicarbonate in Normal Range (22 - 29 mEq/L): TRC101-Placebo||43.7|15.6|< 0.0001
70857762|NCT03390842|141201521|SUPERIORITY||Treatment difference in LS means|1.99|STANDARD_ERROR_OF_MEAN|0.524|=|0.0002|TWO_SIDED|95.0|0.96|3.03|||Mixed-effect repeated measures model||Standard error presented above is for the LS mean.|Least Squares Mean Change from Baseline: TRC101-Placebo||3.03|0.96|= 0.0002
70857763|NCT03390842|141201522|SUPERIORITY||||||<|0.0001||||||p-value based on analysis of covariance model with rank of change from baseline in total score as dependent variable; treatment (PBO or TRC101) as a fixed effect; and baseline total score, Baseline eGFR, Baseline Bicarbonate as continuous covariates.|ANCOVA|||Mean Change from Baseline in KDQOL-PFD: TRC101-Placebo||||< 0.0001
71126366|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.29|||||TWO_SIDED|95.0|0.97|1.72||||||Serogroup A-Vaccine comparison at day 4(Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||1.72|0.97|
71089343|NCT03704064|141685208|SUPERIORITY||Odds Ratio (OR)|2.2||||0.24|TWO_SIDED|95.0|0.6|8.1|||Mixed Models Analysis|||||8.1|0.6|0.24
70857764|NCT03390842|141201523|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Change from Baseline for Repeated Chair Stand Test: TRC101-Placebo||||< 0.0001
71089344|NCT03704064|141685209|SUPERIORITY||Odds Ratio (OR)|3.0||||0.07|TWO_SIDED|95.0|0.9|9.6|||Mixed Models Analysis|||||9.6|0.9|0.07
71089345|NCT03704064|141685210|SUPERIORITY||Odds Ratio (OR)|2.6||||0.21|TWO_SIDED|95.0|0.6|11.4|||Mixed Models Analysis|||||11.4|0.6|0.21
71089346|NCT03704064|141685211|SUPERIORITY||Mean Difference (Net)|2.4|STANDARD_ERROR_OF_MEAN|5.8||0.62|TWO_SIDED||||||Mixed Models Analysis|||MVPA per day with 10 minute bouts||||0.62
71089347|NCT03704064|141685211|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|4.5||0.92|TWO_SIDED||||||Mixed Models Analysis|||MVPA per day with 20 minute bouts||||0.92
71089348|NCT03704064|141685211|SUPERIORITY||Mean Difference (Net)|13.4|STANDARD_ERROR_OF_MEAN|9.6||0.16|TWO_SIDED||||||Mixed Models Analysis|||Moderate activity per day||||0.16
71089349|NCT03704064|141685211|SUPERIORITY||Mean Difference (Net)|15.9|STANDARD_ERROR_OF_MEAN|20.8||0.41|TWO_SIDED||||||Mixed Models Analysis|||Light activity per day||||0.41
71089350|NCT03704064|141685212|SUPERIORITY||Mean Difference (Net)|4.1|STANDARD_ERROR_OF_MEAN|6.1||0.46|TWO_SIDED||||||Mixed Models Analysis|||MVPA per day with 10 minute bouts||||0.46
71089351|NCT03704064|141685212|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|4.9||0.87|TWO_SIDED||||||Mixed Models Analysis|||MVPA per day with 20 minute bouts||||0.87
71089352|NCT03704064|141685212|SUPERIORITY||Mean Difference (Net)|18.5|STANDARD_ERROR_OF_MEAN|10.1||0.07|TWO_SIDED||||||Mixed Models Analysis|||Moderate activity per day||||0.07
71089353|NCT03704064|141685212|SUPERIORITY||Mean Difference (Net)|30.0|STANDARD_ERROR_OF_MEAN|22.5||0.17|TWO_SIDED||||||Mixed Models Analysis|||Light activity per day||||0.17
71089354|NCT03704064|141685213|SUPERIORITY||Mean Difference (Net)|2.2|STANDARD_ERROR_OF_MEAN|5.7||0.63|TWO_SIDED||||||Mixed Models Analysis|||MVPA per day with 10 minute bouts||||0.63
71089355|NCT03704064|141685213|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|3.7||0.72|TWO_SIDED||||||Mixed Models Analysis|||MVPA per day with 20 minute bouts||||0.72
71089356|NCT03704064|141685213|SUPERIORITY||Mean Difference (Net)|6.0|STANDARD_ERROR_OF_MEAN|9.4||0.52|TWO_SIDED||||||Mixed Models Analysis|||Moderate activity per day||||0.52
71089357|NCT03704064|141685213|SUPERIORITY||Mean Difference (Net)|-21.8|STANDARD_ERROR_OF_MEAN|19.4||0.27|TWO_SIDED||||||Mixed Models Analysis|||Light activity per day||||0.27
71089358|NCT03704064|141685214|SUPERIORITY||Mean Difference (Net)|7.3|STANDARD_ERROR_OF_MEAN|151.2||0.84|TWO_SIDED||||||Mixed Models Analysis|||||||0.84
71089359|NCT03704064|141685215|SUPERIORITY||Mean Difference (Net)|-111.7|STANDARD_ERROR_OF_MEAN|137.2||0.53|TWO_SIDED||||||Mixed Models Analysis|||||||0.53
71089360|NCT03704064|141685216|SUPERIORITY||Mean Difference (Net)|163.2|STANDARD_ERROR_OF_MEAN|154.0||0.27|TWO_SIDED||||||Mixed Models Analysis|||||||0.27
71089361|NCT03704064|141685217|SUPERIORITY||Mean Difference (Net)|5.7|STANDARD_ERROR_OF_MEAN|4.6||0.22|TWO_SIDED||||||Mixed Models Analysis|||||||0.22
71089362|NCT03704064|141685218|SUPERIORITY||Mean Difference (Net)|5.3|STANDARD_ERROR_OF_MEAN|4.6||0.24|TWO_SIDED||||||Mixed Models Analysis|||||||0.24
71089363|NCT03704064|141685219|SUPERIORITY||Mean Difference (Net)|3.2|STANDARD_ERROR_OF_MEAN|4.5||0.48|TWO_SIDED||||||Mixed Models Analysis|||||||0.48
71089364|NCT03704064|141685220|SUPERIORITY||Mean Difference (Net)|4.9|STANDARD_ERROR_OF_MEAN|3.4||0.16|TWO_SIDED||||||Mixed Models Analysis|||||||0.16
71089365|NCT03704064|141685221|SUPERIORITY||Mean Difference (Net)|6.8|STANDARD_ERROR_OF_MEAN|3.4||0.045|TWO_SIDED||||||Mixed Models Analysis|||||||0.045
71089366|NCT03704064|141685222|SUPERIORITY||Mean Difference (Net)|3.7|STANDARD_ERROR_OF_MEAN|3.4||0.27|TWO_SIDED||||||Mixed Models Analysis|||||||0.27
71089367|NCT03704064|141685223|SUPERIORITY||Mean Difference (Net)|3.9|STANDARD_ERROR_OF_MEAN|9.4||0.72|TWO_SIDED||||||Mixed Models Analysis|||||||0.72
71089368|NCT03704064|141685224|SUPERIORITY||Mean Difference (Net)|-3.3|STANDARD_ERROR_OF_MEAN|9.1||0.67|TWO_SIDED||||||Mixed Models Analysis|||||||0.67
71089369|NCT03704064|141685225|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|2.5||0.8|TWO_SIDED||||||Mixed Models Analysis|||Systolic Blood Pressure||||0.80
71089370|NCT03704064|141685225|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|1.1||0.94|TWO_SIDED||||||Mixed Models Analysis|||Diastolic Blood Pressure||||0.94
71089371|NCT03704064|141685226|SUPERIORITY||Mean Difference (Net)|-4.3|STANDARD_ERROR_OF_MEAN|2.3||0.07|TWO_SIDED||||||Mixed Models Analysis|||Systolic Blood Pressure||||0.07
71089372|NCT03704064|141685226|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|1.5||0.96|TWO_SIDED||||||Mixed Models Analysis|||Diastolic Blood Pressure||||0.96
71089373|NCT03704064|141685227|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3|TWO_SIDED||||||Mixed Models Analysis|||||||0.30
71089374|NCT03704064|141685228|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.67|TWO_SIDED||||||Mixed Models Analysis|||||||0.67
71089375|NCT03704064|141685229|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.45|TWO_SIDED||||||Mixed Models Analysis|||||||0.45
71089376|NCT03704064|141685230|SUPERIORITY||Odds Ratio (OR)|1.7||||0.38|TWO_SIDED|95.0|0.5|5.9|||Mixed Models Analysis|||||5.9|0.5|0.38
71089377|NCT03704064|141685231|SUPERIORITY||Odds Ratio (OR)|1.0||||0.95|TWO_SIDED|95.0|0.3|3.3|||Mixed Models Analysis|||||3.3|0.3|0.95
71089378|NCT03704064|141685232|SUPERIORITY||Odds Ratio (OR)|1.0||||0.99|TWO_SIDED|95.0|0.3|3.1|||Mixed Models Analysis|||||3.1|0.3|0.99
71089379|NCT03704064|141685233|SUPERIORITY||Mean Difference (Net)|-3.0|STANDARD_ERROR_OF_MEAN|1.6||0.06|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-Total||||0.06
71089380|NCT03704064|141685233|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.9||0.06|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-SD||||0.06
71089381|NCT03704064|141685233|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|0.9||0.19|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-FE||||0.19
71089382|NCT03704064|141685234|SUPERIORITY||Mean Difference (Net)|-3.0|STANDARD_ERROR_OF_MEAN|1.5||0.05|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-Total||||0.05
71089383|NCT03704064|141685234|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|0.9||0.18|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-SD||||0.18
71089384|NCT03704064|141685234|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.9||0.046|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-FE||||0.046
70857765|NCT01653132|141201568|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.194|STANDARD_DEVIATION|0.61|||TWO_SIDED|95.0|-0.71|0.32|||||negative values correspond to a reduction in saliva weight with Inco-A.|Based on the primary outcome measure of mean reduction in saliva weight at 1 month post Inco-A /placebo as compared to baseline, using paired t-test with a two-sided nominal significance (alpha) of 0.05, assuming a correlation of 0.5 between observations, a sample size of 10 pairs has a power of 0.803 to detect a 50% difference in salivary weight.||0.32|-0.71|
71089385|NCT03704064|141685235|SUPERIORITY||Mean Difference (Net)|-2.7|STANDARD_ERROR_OF_MEAN|1.5||0.07|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-Total||||0.07
71089386|NCT03704064|141685235|SUPERIORITY||Mean Difference (Net)|-1.5|STANDARD_ERROR_OF_MEAN|0.9||0.11|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-SD||||0.11
71089387|NCT03704064|141685235|SUPERIORITY||Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|0.9||0.15|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-FE||||0.15
71089388|NCT03704064|141685236|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.3||0.04|TWO_SIDED||||||ANOVA|||Overall treatment acceptability||||0.04
71126367|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.94|||||TWO_SIDED|95.0|0.76|1.17||||||Serogroup A-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)||1.17|0.76|
71126368|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|5.19|||||TWO_SIDED|95.0|2.84|9.47||||||Serogroup A-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)||9.47|2.84|
71126369|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|4.1|||||TWO_SIDED|95.0|2.24|7.5||||||Serogroup A-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)||7.50|2.24|
71126370|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|4.62|||||TWO_SIDED|95.0|2.62|8.15||||||Serogroup A-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||8.15|2.62|
71126371|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.27|||||TWO_SIDED|95.0|0.84|1.91||||||Serogroup A-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)||1.91|0.84|
71126372|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|6.54|||||TWO_SIDED|95.0|4.84|8.85||||||Serogroup A-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)||8.85|4.84|
71126373|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|7.37|||||TWO_SIDED|95.0|5.44|9.98||||||Serogroup A-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)||9.98|5.44|
71126374|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|6.94|||||TWO_SIDED|95.0|5.23|9.21||||||Serogroup A-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||9.21|5.23|
71126375|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.89|||||TWO_SIDED|95.0|0.72|1.1||||||Serogroup A-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)||1.10|0.72|
71126376|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|between group GMT ratios|3.43|||||TWO_SIDED|95.0|1.95|6.04||||||Serogroup C-Vaccine comparison at day 4 (Menveo-Menveo vs. Naive)||6.04|1.95|
71126377|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.14|||||TWO_SIDED|95.0|1.21|3.77||||||Serogroup C-Vaccine comparison at day 4 (Menactra-Menveo vs. Naive)||3.77|1.21|
71126378|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.72|||||TWO_SIDED|95.0|1.6|4.64||||||Serogroup C-Vaccine comparison at day 4 - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||4.64|1.60|
71126379|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.61|||||TWO_SIDED|95.0|1.07|2.4||||||Serogroup C-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)||2.40|1.07|
71089389|NCT03704064|141685236|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.35|TWO_SIDED||||||ANOVA|||BWL component acceptability||||0.35
71089390|NCT03704064|141685236|SUPERIORITY||Mean Difference (Net)|1.5|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED||||||ANOVA|||BIAS vs recipe component acceptability||||<0.001
70857766|NCT01653132|141201569|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.3|STANDARD_DEVIATION|0.34|||TWO_SIDED|95.0|-50.8|6.2|||||negative numbers represent reduction in saliva weight with Inco-A|||6.2|-50.8|
70857767|NCT01653132|141201570|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.33|STANDARD_DEVIATION|1.41|||TWO_SIDED|95.0|-1.16|0.69|||||negative values represent reduction in scores (improvement in drooling) with Inco-A|||0.69|-1.16|
70857768|NCT01653132|141201571|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.333|||||TWO_SIDED|95.0|-0.633|0.071||||||||0.071|-0.633|
70857769|NCT01653132|141201572|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.11|||||TWO_SIDED|95.0|-0.46|0.28||||||||0.28|-0.46|
71126380|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|13.75|||||TWO_SIDED|95.0|7.51|25.19||||||Serogroup C-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)||25.19|7.51|
71126381|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|13.42|||||TWO_SIDED|95.0|7.31|24.66||||||Serogroup C-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)||24.66|7.31|
71126382|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|13.59|||||TWO_SIDED|95.0|7.7|24.0||||||Serogroup C-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||24.00|7.70|
71126383|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.02|||||TWO_SIDED|95.0|0.67|1.56||||||Serogroup C-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)||1.56|0.67|
71126384|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|19.43|||||TWO_SIDED|95.0|13.73|27.51||||||Serogroup C-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)||27.51|13.73|
71126385|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|17.72|||||TWO_SIDED|95.0|12.5|25.12||||||Serogroup C-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)||25.12|12.50|
71126386|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|18.57|||||TWO_SIDED|95.0|13.4|25.73||||||Serogroup C-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||25.73|13.40|
70857770|NCT03828370|141201573|SUPERIORITY|||||||0.04|||||||ANOVA|||||||.04
70857771|NCT03828370|141201574|SUPERIORITY|||||||0.034|||||||Chi-squared|||||||.034
70857772|NCT00461331|141201585|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|96.4|STANDARD_DEVIATION|8.5||0.52||95.0|87.9|100.0|||Regression, Linear|7 patients underwent early termination of either one or both of their test period due to loss of glycemic control||Glucose levels for patients when they were on each insulin were analyzed. All data was analyzed on an intention to treat basis. Repeated measures, paired t-test and Pearson's correlation on SPSS 14.0 for windows and statistical R-package were used to compare the various variables. This was a pilot study.||100.0|87.9|0.52
70857773|NCT00461331|141201586|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.35|STANDARD_DEVIATION|4.165||0.15||95.0|0.97|9.23|||Regression, Linear||This was between days 3 and 5 after the last pump infusion line change using Insulin Aspart and Insulin Lispro. Adequate samples were not available to do the analysis for day 2.|All data was analyzed on an intention to treat basis. Repeated measures, paired t-test and Pearson's correlation on SPSS 14.0 for windows and statistical R-package were used to compare the various variables.||9.23|0.97|0.15
70857774|NCT00461331|141201587|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.7|STANDARD_DEVIATION|2.35||0.55||95.0|4.4|9.4|||Regression, Linear||This was for test period 1 between days 3 and 5 after the last pump infusion line change.|All data was analyzed on an intention to treat basis. Repeated measures, paired t-test and Pearson's correlation on SPSS 14.0 for windows and statistical R-package were used to compare the various variables.||9.4|4.4|0.55
71126387|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.1|||||TWO_SIDED|95.0|0.86|1.4||||||Serogroup C-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)||1.40|0.86|
71126388|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.88|||||TWO_SIDED|95.0|1.13|3.11||||||Serogroup W-Vaccine comparison at day 4 (Menveo-Menveo vs. Naive)||3.11|1.13|
71126389|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.46|||||TWO_SIDED|95.0|1.48|4.08||||||Serogroup W-Vaccine comparison at day 4 (Menactra-Menveo vs. Naive)||4.08|1.48|
71126390|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.14|||||TWO_SIDED|95.0|1.33|3.44||||||Serogroup W-Vaccine comparison at day 4 - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||3.44|1.33|
71126391|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.76|||||TWO_SIDED|95.0|0.53|1.1||||||Serogroup W-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)||1.10|0.53|
71126392|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|7.04|||||TWO_SIDED|95.0|4.05|12.22||||||Serogroup W-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)||12.22|4.05|
71126393|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|8.99|||||TWO_SIDED|95.0|5.16|15.66||||||Serogroup W-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)||15.66|5.16|
71126394|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|7.94|||||TWO_SIDED|95.0|4.72|13.35||||||Serogroup W-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||13.35|4.72|
71089391|NCT03704064|141685236|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.2||0.01|TWO_SIDED||||||ANOVA|||BWL skill acquisition||||0.01
71089392|NCT03704064|141685236|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED||||||ANOVA|||Stigma-related skill acquisition||||<0.001
71089393|NCT03704064|141685236|SUPERIORITY||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED||||||ANOVA|||Stigma-related skill use||||<0.001
71089394|NCT03704064|141685237|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.24|TWO_SIDED||||||ANOVA|||Overall treatment acceptability||||0.24
71089395|NCT03704064|141685237|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.28|TWO_SIDED||||||ANOVA|||BWL component acceptability||||0.28
71089396|NCT03704064|141685237|SUPERIORITY||Mean Difference (Net)|1.8|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED||||||ANOVA|||BIAS vs recipe component acceptability||||<0.001
71089397|NCT03704064|141685237|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.34|TWO_SIDED||||||ANOVA|||BWL skill acquisition||||0.34
71089398|NCT03704064|141685237|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|0.3||0.008|TWO_SIDED||||||ANOVA|||Stigma-related skill acquisition||||0.008
71089399|NCT03704064|141685237|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.2||0.001|TWO_SIDED||||||ANOVA|||Stigma-related skill use||||0.001
71089400|NCT00062166|141685288|NON_INFERIORITY|Time dependent risk for requiring an intervention for pancreatic neuroendocrine tumors (PNET), among 63 patients with PNETs with diameter \>1.2 and \<3 cm, and a known position of germline VHL pathogenic variant (n=63). Comparison between exon 3 vs exon 1 and 2.|Hazard Ratio (HR)|3.3||||0.02|TWO_SIDED|95.0|1.2|9.1|||Regression, Cox|||||9.1|1.2|0.02
71089401|NCT02475369|141685292|SUPERIORITY|||||||0.271|||||||Wilcoxon (Mann-Whitney)|||||||0.271
71089402|NCT02475369|141685293|OTHER|In order to calculate a correlation between baseline fecal elastase-1 and total CeD-GSRS score on PES treatment vs. placebo treatment, we calculated a Spearman's rank correlation coefficient between the two independent variables.||||||0.995|||||||Spearman rank coefficient|||||||0.995
71089403|NCT02475369|141685294|OTHER|In order to evaluate the estimated difference of the effect of Pancreatic Enzyme Supplement versus Placebo for the Celiac Symptom Index (CSI) scores, we used a linear mixed effects model with the nlme package.||||||0.08|||||||Linear Mixed Effects model|||||||0.08
71089404|NCT01621009|141685315|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61|||>|0.05|TWO_SIDED|95.0|0.78|3.36|||Regression, Logistic|||||3.36|.78|>0.05
71089405|NCT01621009|141685315|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13|||>|0.05|TWO_SIDED|95.0|0.52|2.44|||Regression, Logistic|||||2.44|.52|>0.05
71089406|NCT02717195|141685340|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.9196|TWO_SIDED|95.0|-2.37|2.13||Multiplicity adjustment was planned for the testing of the primary enpoint, but was not applied since all p-values\>0.05.|Mixed model repeated measures|||The mean changes from Randomization in PANSS total score was analysed using a MMRM approach. The model included the fixed, categorical effects of treatment, country, week, treatment-by-week interaction, PC Period treatment, PC Period treatment-by-week interaction, and the continuous covariates of Randomization score and Randomization score-by-week interaction with an unstructured covariance structure to model the within-patient errors.||2.13|-2.37|0.9196
71089407|NCT02717195|141685340|SUPERIORITY||Mean Difference (Final Values)|1.67||||0.1474|TWO_SIDED|95.0|-0.59|3.94||Multiplicity adjustment was planned for the testing of the primary endpoint, but was not applied since all p-values\>0.05.|Mixed model repeated measures|||The mean changes from Randomization in PANSS total score was analysed using a MMRM approach. The model included the fixed, categorical effects of treatment, country, week, treatment-by-week interaction, PC Period treatment, PC Period treatment-by-week interaction, and the continuous covariates of Randomization score and Randomization score-by-week interaction with an unstructured covariance structure to model the within-patient errors.||3.94|-0.59|0.1474
71089408|NCT02717195|141685341|SUPERIORITY||Mean Difference (Final Values)|0.96||||0.2998|TWO_SIDED|95.0|-0.86|2.78||Multiplicity adjustment was planned for the testing of the primary endpoint, but was not applied since all p-values\>0.05.|Mixed model repeated measures|||The mean changes from Randomization in PSP score was analysed using a MMRM approach. The model included the fixed, categorical effects of treatment, country, week, treatment-by-week interaction, PC Period treatment, PC Period treatment-by-week interaction, and the continuous covariates of Randomization score and Randomization score-by-week interaction with an unstructured covariance structure to model the within-patient errors.||2.78|-0.86|0.2998
71089409|NCT02717195|141685341|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.4478|TWO_SIDED|95.0|-2.54|1.12||Multiplicity adjustment was planned for the testing of the primary endpoint, but was not applied since all p-values\>0.05.|Mixed model repeated measures|||The mean changes in PSP score was analysed using a MMRM approach. The model included the fixed, categorical effects of treatment, country, week, treatment-by-week interaction, PC Period treatment, PC Period treatment-by-week interaction, and the continuous covariates of Randomization score and Randomization score-by-week interaction with an unstructured covariance structure to model the within-patient errors.||1.12|-2.54|0.4478
71126395|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.78|||||TWO_SIDED|95.0|0.54|1.14||||||Serogroup W-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)||1.14|0.54|
71126396|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|25.21|||||TWO_SIDED|95.0|17.83|35.65||||||Serogroup W-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)||35.65|17.83|
70946374|NCT00551135|141392986|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4465|TWO_SIDED||||||ANOVA|||Magnification change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4465
71089410|NCT00855218|141685348|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.797||||0.072||95.0|0.588|1.08||stratified one-sided (alpha=0.15). adjusted for region and Alfa-fetoprotein (AFP) level at baseline.|Log Rank|||||1.080|0.588|0.072
71089411|NCT00855218|141685349|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.898||||0.295||95.0|0.606|1.33|||Log Rank|stratified one-sided (alpha=0.15). adjusted for region and AFP level at baseline.||||1.330|0.606|0.295
71089412|NCT00855218|141685350|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.586||||0.999||95.0|1.2|2.096|||Log Rank|startified one-sided (alpha=0.15), adjusted for region and AFP level at baseline||||2.096|1.200|0.999
71089413|NCT00855218|141685351|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.621||||0.076||95.0|0.321|1.2|||Log Rank|stratified one sided (alpha=0.15), adjusted on region and AFP level at baseline||||1.200|0.321|0.076
71089414|NCT03191552|141685363|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71089415|NCT03191552|141685364|SUPERIORITY|||||||0.027||||||Mann-Whitney U test was used to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.|Kruskal-Wallis|||||||0.027
71089416|NCT03191552|141685365|SUPERIORITY|||||||0.008||||||Mann-WhitneyU test was used to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.|Kruskal-Wallis|||||||0.008
71089417|NCT03191552|141685366|SUPERIORITY|Mann-WhitneyU test was used to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.||||||0.004||||||Mann-WhitneyU test was performed to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.|Kruskal-Wallis|||||||0.004
71089418|NCT03191552|141685367|SUPERIORITY|||||||0.837|||||||Kruskal-Wallis|||||||0.837
71089419|NCT03191552|141685368|SUPERIORITY|||||||0.57|||||||Kruskal-Wallis|||||||0.570
71126397|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|34.06|||||TWO_SIDED|95.0|24.06|48.23||||||Serogroup W-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)||48.23|24.06|
71089420|NCT03191552|141685369|SUPERIORITY|||||||0.334|||||||Kruskal-Wallis|||||||0.334
71089421|NCT03191552|141685370|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71089422|NCT03191552|141685371|SUPERIORITY|||||||0.77|||||||Kruskal-Wallis|||||||0.77
71089423|NCT03191552|141685372|SUPERIORITY|||||||0.889|||||||Kruskal-Wallis|||||||0.889
71089424|NCT03191552|141685373|SUPERIORITY|||||||0.956|||||||Kruskal-Wallis|||||||0.956
71089425|NCT03191552|141685374|SUPERIORITY||||||,|0||||||Mann-WhitneyU test was used to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.|Kruskal-Wallis|||||||0,001
71089426|NCT03191552|141685375|SUPERIORITY|||||||0.14|||||||Kruskal-Wallis|||||||0.14
71089427|NCT03191552|141685376|SUPERIORITY|||||||0.08|||||||Kruskal-Wallis|||||||0.08
71089428|NCT03191552|141685377|SUPERIORITY|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||||||0.314
71089429|NCT03191552|141685378|SUPERIORITY|||||||0.244|||||||Wilcoxon (Mann-Whitney)|||||||0.244
71089430|NCT03191552|141685379|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
71089431|NCT01265498|141685380|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.9||||0.0002|TWO_SIDED|95.0|1.3|2.8|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status.|obeticholic acid vs placebo|||2.8|1.3|0.0002
71089432|NCT01265498|141685381|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.5||||0.08|TWO_SIDED|95.0|0.9|2.6|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs placebo|||2.6|0.9|0.08
71089433|NCT01265498|141685382|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.8||||0.004|TWO_SIDED|95.0|1.1|2.7|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs placebo|||2.7|1.1|0.004
71089434|NCT01265498|141685383|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.01|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.1|-0.6|0.01
71089435|NCT01265498|141685384|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.5|-1.3|<0.0001
71089436|NCT01265498|141685385|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.5||||0.03|TWO_SIDED|95.0|1.0|2.1|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs placebo|||2.1|1.0|0.03
71089437|NCT01265498|141685386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.03|TWO_SIDED|95.0|-0.5|0.0|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.0|-0.5|0.03
70857775|NCT03312751|141201588|SUPERIORITY||Overall response rate|62.9||||0.0053|TWO_SIDED|95.0|44.9|78.5|||Exact binomial|||The primary efficacy endpoint was analyzed with an exact binomial test to evaluate the null hypothesis that the Overall Response Rate was, at most, 40%. This test was performed at the one sided 0.025 significance level.||78.5|44.9|0.0053
71089438|NCT01265498|141685387|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.7||||0.001|TWO_SIDED|95.0|1.2|2.3|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs. placebo|||2.3|1.2|0.001
71089439|NCT01265498|141685388|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.0004|TWO_SIDED|95.0|-0.6|-0.2|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.2|-0.6|0.0004
71089440|NCT01265498|141685389|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.6||||0.006|TWO_SIDED|95.0|1.1|2.2|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs. placebo|||2.2|1.1|0.006
71089441|NCT01265498|141685390|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.0006|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.1|-0.5|0.0006
71089442|NCT01265498|141685391|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.9|TWO_SIDED|95.0|0.6|1.7|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs. placebo|||1.7|0.6|0.90
71089443|NCT01265498|141685392|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.59|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.2|-0.1|0.59
71089444|NCT01265498|141685393|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.0|||<|0.0001|TWO_SIDED|95.0|-28.0|-11.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-11|-28|<0.0001
71089445|NCT01265498|141685394|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.0||||0.0001|TWO_SIDED|95.0|-18.0|-6.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-6|-18|0.0001
71089446|NCT01265498|141685395|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.0|||<|0.0001|TWO_SIDED|95.0|13.0|24.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||24|13|<0.0001
71089447|NCT01265498|141685396|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.0|||<|0.0001|TWO_SIDED|95.0|-35.0|-14.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-14|-35|<0.0001
71089448|NCT01265498|141685397|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.002|TWO_SIDED|95.0|-2.4|-0.5|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.5|-2.4|0.002
71089449|NCT01265498|141685398|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.38||||0.0009|TWO_SIDED|95.0|0.16|0.6|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.60|0.16|0.0009
71089450|NCT01265498|141685399|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.01|TWO_SIDED|95.0|-0.1|-0.01|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.01|-0.10|0.01
71089451|NCT01265498|141685400|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.45|||<|0.0001|TWO_SIDED|95.0|0.26|0.65|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.65|0.26|<0.0001
71089452|NCT01265498|141685401|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.88|TWO_SIDED|95.0|-0.35|0.3|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.30|-0.35|0.88
71089453|NCT01265498|141685402|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.72|TWO_SIDED|95.0|-1.8|2.6|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||2.6|-1.8|0.72
71089454|NCT01265498|141685403|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.71|TWO_SIDED|95.0|-0.01|0.01|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.01|-0.01|0.71
71089455|NCT01265498|141685404|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1||||0.002|TWO_SIDED|95.0|-1.8|-0.4|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.4|-1.8|0.002
71126398|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|29.24|||||TWO_SIDED|95.0|21.09|40.52||||||Serogroup W-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||40.52|21.09|
71126399|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.74|||||TWO_SIDED|95.0|0.58|0.94||||||Serogroup W-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)||0.94|0.58|
71126400|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.35|||||TWO_SIDED|95.0|1.36|4.07||||||Serogroup Y-Vaccine comparison at day 4 (Menveo-Menveo vs. Naive)||4.07|1.36|
71126401|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.62|||||TWO_SIDED|95.0|1.51|4.54||||||Serogroup Y-Vaccine comparison at day 4 (Menactra-Menveo vs. Naive)||4.54|1.51|
71126402|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.48|||||TWO_SIDED|95.0|1.48|4.14||||||Serogroup Y-Vaccine comparison at day 4 - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||4.14|1.48|
71126403|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.9|||||TWO_SIDED|95.0|0.61|1.33||||||Serogroup Y-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)||1.33|0.61|
71089456|NCT01265498|141685405|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.4|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.4|-0.2|0.40
71089457|NCT01265498|141685406|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.0||||0.001|TWO_SIDED|95.0|7.0|26.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||26|7|0.001
71089458|NCT01265498|141685407|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.03|TWO_SIDED|95.0|-1.4|-0.1|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.1|-1.4|0.03
71089459|NCT01265498|141685408|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.04|TWO_SIDED|95.0|0.0|0.04|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.04|0.00|0.04
71089460|NCT01265498|141685409|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.53|TWO_SIDED|95.0|-0.03|0.05|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.05|-0.03|0.53
71089461|NCT01265498|141685410|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.6||||0.03|TWO_SIDED|95.0|0.2|5.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||5.0|0.2|0.03
71089462|NCT01265498|141685411|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.0||||0.05|TWO_SIDED|95.0|0.0|29.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||29|0|0.05
71089463|NCT01265498|141685412|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.13|TWO_SIDED|95.0|-1.2|0.2|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.2|-1.2|0.13
71089464|NCT01265498|141685413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5||||0.31|TWO_SIDED|95.0|-0.5|1.6|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||1.6|-0.5|0.31
71126404|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|9.82|||||TWO_SIDED|95.0|5.47|17.64||||||Serogroup Y-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)||17.64|5.47|
71126405|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|9.55|||||TWO_SIDED|95.0|5.31|17.19||||||Serogroup Y-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)||17.19|5.31|
71089465|NCT01265498|141685414|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.16|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.1|-0.6|0.16
71089466|NCT01265498|141685415|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.002|TWO_SIDED|95.0|-0.04|-0.01|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.01|-0.04|0.002
71089467|NCT01265498|141685416|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.26|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.8|-0.2|0.26
71089468|NCT01265498|141685417|SUPERIORITY_OR_OTHER||Mean Difference (Net)|38.0||||0.02|TWO_SIDED|95.0|6.0|69.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||69|6|0.02
71089469|NCT01265498|141685418|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.0||||0.01|TWO_SIDED|95.0|3.0|23.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||23|3|0.01
71089470|NCT01265498|141685419|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.71|TWO_SIDED|95.0|-1.7|2.6|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||2.6|-1.7|0.71
71089471|NCT01265498|141685420|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2||||0.008|TWO_SIDED|95.0|-3.7|-0.6|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.6|-3.7|0.008
71089472|NCT01265498|141685421|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.01|TWO_SIDED|95.0|-1.3|-0.2|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.2|-1.3|0.01
71089473|NCT01265498|141685422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.7|TWO_SIDED|95.0|-2.2|1.5|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||1.5|-2.2|0.70
71089474|NCT01265498|141685423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.57|TWO_SIDED|95.0|-0.01|0.02|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.02|-0.01|0.57
71089475|NCT01265498|141685424|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0||||0.05|TWO_SIDED|95.0|-7.0|0.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0|-7|0.05
71089476|NCT01265498|141685425|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.23|TWO_SIDED|95.0|-4.0|1.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||1|-4|0.23
71089477|NCT01265498|141685426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0||||0.22|TWO_SIDED|95.0|-1.0|3.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||3|-1|0.22
71089478|NCT01265498|141685427|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.65|TWO_SIDED|95.0|-3.0|2.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||2|-3|0.65
71089479|NCT03880474|141685461|OTHER||Relative Risk|1.52||||0.1146|TWO_SIDED|95.0|0.9|2.55|||Log Binominal Model|||||2.55|0.90|0.1146
71126406|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|9.69|||||TWO_SIDED|95.0|5.59|16.79||||||Serogroup Y-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||16.79|5.59|
71126407|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.03|||||TWO_SIDED|95.0|0.69|1.54||||||Serogroup Y-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)||1.54|0.69|
71126408|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|28.52|||||TWO_SIDED|95.0|20.23|40.2||||||Serogroup Y-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)||40.20|20.23|
71089480|NCT03880474|141685461|OTHER||Relative Risk|1.52||||0.1146|TWO_SIDED|95.0|0.9|2.55|||Poisson Model with Robust Variance|||||2.55|0.90|0.1146
71089481|NCT03880474|141685462|OTHER||Relative Risk|1.0||||1|TWO_SIDED|95.0|0.86|1.15|||Log Binomial Model|||The Analysis concerns the Incidence of Influenza-like Illness (ILI)||1.15|0.86|1.0000
71089482|NCT03880474|141685462|OTHER||Relative Risk|1.0||||0.9799|TWO_SIDED|95.0|0.86|1.15|||Poisson Model with Robust Variance|||The Analysis concerns the Incidence of Influenza-like Illness (ILI)||1.15|0.86|0.9799
71089483|NCT03880474|141685464|OTHER||Least Squares Mean Difference|-287.1||||0.3284|TWO_SIDED|95.0|-872.75|298.59|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza A/H3N2 (HI) at Day 28||298.59|-872.75|0.3284
71089484|NCT03880474|141685464|OTHER||Least Squares Mean Difference|-13.39||||0.8468|TWO_SIDED|95.0|-152.26|125.47|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza A/H3N2 (HI) at Week26||125.47|-152.26|0.8468
71089485|NCT03880474|141685464|OTHER||Least Squares Mean Difference|-465.7||||0.5087|TWO_SIDED|95.0|-1875.21|943.75|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza A/H3N2 (MN) at Day 28||943.75|-1875.21|0.5087
71089486|NCT03880474|141685464|OTHER||Least Squares Mean Difference|-83.68||||0.7509|TWO_SIDED|95.0|-611.67|444.32|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza A/H3N2 (MN) at Week 26||444.32|-611.67|0.7509
71089487|NCT03880474|141685464|OTHER||Least Squares Mean Difference|-81.17||||0.3398|TWO_SIDED|95.0|-250.72|88.39|||ANOVA|||Titers of influenza-specific neutralizing antibodies against Influenza A/H1N1pdm at Day 28||88.39|-250.72|0.3398
71089488|NCT03880474|141685464|OTHER||Least Squares Mean Difference|26.15||||0.4154|TWO_SIDED|95.0|-37.95|90.26|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza A/H1N1pdm at Week 26||90.26|-37.95|0.4154
71089489|NCT03880474|141685464|OTHER||Least Squares Mean Difference|22.84||||0.7193|TWO_SIDED|95.0|-104.5|150.18|||ANCOVA|||Titers of neutralizing antibodies against Influenza B/ Victoria at Day 28||150.18|-104.50|0.7193
71089490|NCT03880474|141685464|OTHER||Least Squares Mean Difference|52.38||||0.1496|TWO_SIDED|95.0|-19.59|124.35|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza B/ Victoria at Week 26||124.35|-19.59|0.1496
70857776|NCT03312751|141201588|SUPERIORITY|||||||0.2839|||||||Exact binomial|||The primary efficacy endpoint was analyzed with an exact binomial test to evaluate the null hypothesis that the Overall Response Rate was, at most, 40%. This test was performed at the one sided 0.025 significance level.||||0.2839
70857777|NCT03312751|141201588|SUPERIORITY|||||||0.0031|||||||Exact binomial|||The primary efficacy endpoint was analyzed with an exact binomial test to evaluate the null hypothesis that the Overall Response Rate was, at most, 40%. This test was performed at the one sided 0.025 significance level.||||0.0031
70857778|NCT00046891|141201624|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||t-test, 2 sided|||Total HSCS Area Under the Curve (AUC) scores between the two treatment arms.||||0.84
70857779|NCT04391569|141201662|OTHER|||||||0||||||P-value from logistic regression is used for interim data, and Boschloo's test p-value is used for post interim data.|fixed weight combination test|P-value is derived by fixed weight (2/3 for interim and 1/3 for post interim) combination test.||||||0.0000
70857780|NCT04391569|141201663|OTHER|||||||0.1619||||||P-value from logistics regression is used for interim data, and Boschloo's test p-value is used for post interim data.|fixed weight combination test|P-value is derive by fixed weight (2/3 for interim and 1/3 for post interim) combination test.||||||0.1619
70857781|NCT04391569|141201665|OTHER|||||||0.2097|||||||fixed weight combination test|||||||0.2097
70857782|NCT04391569|141201666|OTHER|||||||0|||||||Log Rank|||||||0.0000
71089491|NCT03880474|141685464|OTHER||Least Squares Mean Difference|-16.76||||0.9044|TWO_SIDED|95.0|-296.57|263.06|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza B/Yamagata at Day 28||263.06|-296.57|0.9044
71089492|NCT03880474|141685464|OTHER||Least Squares Mean Difference|38.64||||0.4198|TWO_SIDED|95.0|-56.97|134.24|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza B/Yamagata at Week 26||134.24|-56.97|0.4198
71089493|NCT03880474|141685465|OTHER||Hazard Ratio (HR)|1.08||||0.4159|TWO_SIDED|95.0|0.9|1.28|||Regression, Cox|||||1.28|0.90|0.4159
71089494|NCT03880474|141685466|OTHER||Geometric Mean Ratio (Active vs Placebo)|0.99||||0.955|TWO_SIDED|95.0|0.83|1.19|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Feeling Hot (AUC)||1.19|0.83|0.9550
71089495|NCT03880474|141685466|OTHER||Geometric Mean Ratio (Active vs Placebo)|1.0||||0.8933|TWO_SIDED|95.0|1.0|1.0|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Temperature (AUC)||1|1|0.8933
71089496|NCT03880474|141685466|OTHER||Geometric Mean Ratio (Active vs Placebo)|0.87||||0.2156|TWO_SIDED|95.0|0.7|1.09|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Cough (AUC)||1.09|0.7|0.2156
71089497|NCT03880474|141685466|OTHER||Geometric Mean Ratio (Active vs Placebo)|0.88||||0.2216|TWO_SIDED|95.0|0.71|1.1|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Sore Throat AUC||1.10|0.71|0.2216
71089498|NCT03880474|141685466|OTHER||Geometric Mean Ratio (Active vs Placebo)|0.87||||0.2306|TWO_SIDED|95.0|0.69|1.09|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Blocked Nose AUC||1.09|0.69|0.2306
71089499|NCT03880474|141685466|OTHER||Geometric Mean Ratio (Active vs Placebo)|0.99||||0.8038|TWO_SIDED|95.0|0.97|1.13|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Chest Pain AUC||1.13|0.97|0.8038
71089500|NCT03880474|141685466|OTHER||Geometric Mean Ratio (Active vs Placebo)|1.01||||0.9319|TWO_SIDED|95.0|0.84|1.21|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Muscle Pain AUC||1.21|0.84|0.9319
71089501|NCT03880474|141685466|OTHER||Geometric Mean Ratio (Active vs Placebo)|1.01||||0.8399|TWO_SIDED|95.0|0.86|1.19|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Shortness of Breath AUC||1.19|0.86|0.8399
71089502|NCT03880474|141685467|OTHER||Least Squares Mean Difference|743.78||||0|TWO_SIDED|95.0|443.71|1043.84|||ANCOVA|||Statistical analysis was performed for Total(NP+M) (SFU/10\^6 PBMC) at Day 28 Nucleoprotein = NP, matrix1 = M1||1043.84|443.71|0
71089503|NCT03880474|141685467|OTHER||Least Squares Mean Difference|177.1||||0.0673|TWO_SIDED|95.0|-13.14|367.33|||ANCOVA|||Statistical analysis was performed for Total(NP+M) (SFU/10\^6 PBMC) at Week 26 Nucleoprotein = NP, matrix1 = M1||367.33|-13.14|0.0673
70946375|NCT00551135|141392986|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4385|TWO_SIDED||||||ANOVA|||Magnification change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4385
70946376|NCT00551135|141392986|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2265|TWO_SIDED||||||ANOVA|||Magnification change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2265
71089504|NCT00921024|141685468|SUPERIORITY_OR_OTHER||Risk Difference (RD)|6.8|||||TWO_SIDED|||||||||||||
70857783|NCT04391569|141201667|OTHER|||||||0.0075||||||P-value is derived by fixed weight (2/3 for interim and 1/3 for post interim) combination test. P-value from logistics regression is used for interim data, and Boschloo's test p-value is used for post interim data.|fixed weight combination test|||||||0.0075
70946377|NCT00551135|141392986|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5985|TWO_SIDED||||||ANOVA|||Magnification change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5985
70857784|NCT00773838|141201680|OTHER|||||||0.419|||||||Exact Test for Binomial Parameter|||||||0.419
70857785|NCT04445792|141201693|SUPERIORITY|||||||0.7195|||||||Wilcoxon (Mann-Whitney)|||||||0.7195
70857786|NCT04445792|141201693|SUPERIORITY|||||||0.8054|||||||Wilcoxon (Mann-Whitney)|||||||0.8054
70857787|NCT04445792|141201693|SUPERIORITY|||||||0.861|||||||Wilcoxon (Mann-Whitney)|||||||0.861
71089505|NCT00921024|141685469|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-7.1|||||TWO_SIDED|||||||||||||
71089506|NCT00737178|141685521|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Chi-squared|||||||<.01
71089507|NCT00737178|141685523|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Chi-squared|||||||0.24
71089508|NCT00427934|141685537|SUPERIORITY_OR_OTHER||Percentage Difference|-1.73||||0.79||90.0|-15.13|8.68|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 1||8.68|-15.13|0.790
71089509|NCT00427934|141685537|SUPERIORITY_OR_OTHER||Percentage Difference|0.43||||0.477||90.0|-13.67|11.64|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 2||11.64|-13.67|0.477
71089510|NCT00427934|141685537|SUPERIORITY_OR_OTHER||Percentage Difference|3.03||||0.37||90.0|-12.85|16.77|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 4||16.77|-12.85|0.370
71089511|NCT00427934|141685537|SUPERIORITY_OR_OTHER||Percentage Difference|8.66||||0.175||90.0|-7.07|22.03|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 8||22.03|-7.07|0.175
71089512|NCT00427934|141685538|SUPERIORITY_OR_OTHER||Percentage Difference|1.3||||0.42||90.0|-6.34|6.01|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 1||6.01|-6.34|0.420
71089513|NCT00427934|141685538|SUPERIORITY_OR_OTHER||Percentage Difference|2.6||||0.258||90.0|-5.08|7.95|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 2||7.95|-5.08|0.258
71089514|NCT00427934|141685538|SUPERIORITY_OR_OTHER||Percentage Difference|-3.46||||1||90.0|-14.39|3.42|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 4||3.42|-14.39|1.000
71089515|NCT00427934|141685538|SUPERIORITY_OR_OTHER||Percentage Difference|-1.3||||0.899||90.0|-13.56|7.92|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 8||7.92|-13.56|0.899
71089516|NCT00427934|141685538|SUPERIORITY_OR_OTHER||Percentage Difference|1.3||||0.489||90.0|-11.24|10.96|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 12||10.96|-11.24|0.489
71089517|NCT00427934|141685539|SUPERIORITY_OR_OTHER||Percentage Difference|-3.03||||1||90.0|-13.59|1.28|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 4||1.28|-13.59|1.000
71089518|NCT00427934|141685539|SUPERIORITY_OR_OTHER||Percentage Difference|2.6||||0.258||90.0|-5.08|7.95|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 8||7.95|-5.08|0.258
71089519|NCT00427934|141685539|SUPERIORITY_OR_OTHER||Percentage Difference|-3.03||||1||90.0|-13.59|1.28|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 12||1.28|-13.59|1.000
71089520|NCT00427934|141685540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.335||90.0|-0.79|2.99||This analysis was carried out using analysis of covariance (ANCOVA) with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||2.99|-0.79|0.335
71089521|NCT00427934|141685540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.816||90.0|-1.82|2.41||This analysis was carried out using ANCOVA with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||2.41|-1.82|0.816
71089522|NCT00427934|141685540|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.01||||0.996||90.0|-2.35|2.36||This analysis was carried out using ANCOVA with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||2.36|-2.35|0.996
70857788|NCT04445792|141201694|SUPERIORITY|||||||0.4385|||||||Wilcoxon (Mann-Whitney)|||||||0.4385
70857789|NCT04445792|141201694|SUPERIORITY|||||||0.7185|||||||Wilcoxon (Mann-Whitney)|||||||0.7185
70857790|NCT04445792|141201694|SUPERIORITY|||||||0.431|||||||Wilcoxon (Mann-Whitney)|||||||0.431
70857791|NCT04445792|141201695|SUPERIORITY|||||||0.9222|||||||Wilcoxon (Mann-Whitney)|||||||0.9222
70857792|NCT04445792|141201695|SUPERIORITY|||||||0.1918|||||||Wilcoxon (Mann-Whitney)|||||||0.1918
70857793|NCT04445792|141201695|SUPERIORITY|||||||0.0119|||||||Wilcoxon (Mann-Whitney)|||||||0.0119
70857794|NCT04445792|141201696|SUPERIORITY|||||||0.6971|||||||Wilcoxon (Mann-Whitney)|||||||0.6971
70857795|NCT04445792|141201696|SUPERIORITY|||||||0.2309|||||||Wilcoxon (Mann-Whitney)|||||||0.2309
70857796|NCT04445792|141201696|SUPERIORITY|||||||0.0441|||||||Wilcoxon (Mann-Whitney)|||||||0.0441
70857797|NCT04445792|141201697|SUPERIORITY|||||||0.7988|||||||Wilcoxon (Mann-Whitney)|||||||0.7988
70857798|NCT04445792|141201697|SUPERIORITY|||||||0.0483|||||||Wilcoxon (Mann-Whitney)|||||||0.0483
70857799|NCT04445792|141201697|SUPERIORITY|||||||0.0104|||||||Wilcoxon (Mann-Whitney)|||||||0.0104
70857800|NCT04445792|141201698|SUPERIORITY|||||||0.521|||||||Wilcoxon (Mann-Whitney)|||||||0.521
70857801|NCT04445792|141201698|SUPERIORITY|||||||0.2348|||||||Wilcoxon (Mann-Whitney)|||||||0.2348
70857802|NCT04445792|141201698|SUPERIORITY|||||||0.0517|||||||Wilcoxon (Mann-Whitney)|||||||0.0517
70857803|NCT04445792|141201699|SUPERIORITY|||||||0.6835|||||||Wilcoxon (Mann-Whitney)|||||||0.6835
70857804|NCT04445792|141201699|SUPERIORITY|||||||0.0205|||||||Wilcoxon (Mann-Whitney)|||||||0.0205
70857805|NCT04445792|141201699|SUPERIORITY|||||||0.0036|||||||Wilcoxon (Mann-Whitney)|||||||0.0036
70857806|NCT04445792|141201700|SUPERIORITY|||||||0.5878|||||||Wilcoxon (Mann-Whitney)|||||||0.5878
70857807|NCT04445792|141201700|SUPERIORITY|||||||0.1051|||||||Wilcoxon (Mann-Whitney)|||||||0.1051
70857808|NCT04445792|141201700|SUPERIORITY|||||||0.0292|||||||Wilcoxon (Mann-Whitney)|||||||0.0292
70857809|NCT04445792|141201701|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
70857810|NCT04445792|141201701|SUPERIORITY|||||||0.5973|||||||Chi-squared|||||||0.5973
70857811|NCT04445792|141201701|SUPERIORITY|||||||0.0046|||||||Chi-squared|||||||0.0046
71089523|NCT00427934|141685540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.61||||0.263||90.0|-3.98|0.76||This analysis was carried out using ANCOVA with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||0.76|-3.98|0.263
70857812|NCT03274999|141201705|SUPERIORITY|||||||0.156||||||Eye-opening, T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.156
70857813|NCT03274999|141201705|SUPERIORITY|||||||0.395||||||Eye-opening, T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.395
70857814|NCT03274999|141201705|SUPERIORITY|||||||0.114||||||Eye-opening, T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.114
70857815|NCT03274999|141201705|SUPERIORITY|||||||0.211||||||Eye-opening, T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.211
70857816|NCT03274999|141201705|SUPERIORITY|||||||0.332||||||Eye-opening, T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.332
70946378|NCT00551135|141392986|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2146|TWO_SIDED||||||ANOVA|||Magnification change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2146
71126409|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|26.94|||||TWO_SIDED|95.0|19.09|38.02||||||Serogroup Y-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)||38.02|19.09|
71126410|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|27.73|||||TWO_SIDED|95.0|20.1|38.26||||||Serogroup Y-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||38.26|20.10|
71126411|NCT02986854|141758872|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.06|||||TWO_SIDED|95.0|0.83|1.35||||||Serogroup Y-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)||1.35|0.83|
70857817|NCT03274999|141201705|SUPERIORITY|||||||0.318||||||Eye-opening, T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.318
70857818|NCT03274999|141201705|SUPERIORITY|||||||0.375||||||Eye-opening, T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.375
70857819|NCT03274999|141201705|SUPERIORITY|||||||0.352||||||Eye-opening, T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.352
70857820|NCT03274999|141201705|SUPERIORITY|||||||0.312||||||Eye-opening, T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.312
71089524|NCT00427934|141685540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.48||||0.294||90.0|-3.82|0.85||This analysis was carried out using ANCOVA with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||0.85|-3.82|0.294
71126412|NCT01972789|141758884|NON_INFERIORITY|This is a non-inferiority study design, with a pre-specified non-inferiority margin of 5 letters between intensive and relaxed groups. That is, if the change from Baseline in BCVA at Month 24 in the intensive group is not more than 5 letters higher than the relaxed group, then the relaxed group is regarded not inferior to the intensive group|Odds Ratio (OR)|0.4||||0.787|TWO_SIDED|95.0|-2.51|3.32|||Mixed Models Analysis|||||3.32|-2.51|0.787
71126413|NCT01972789|141758885|OTHER||Odds Ratio (OR)|-0.31||||0.833|TWO_SIDED|95.0|-3.2|2.58|||Mixed Models Analysis|||||2.58|-3.20|0.833
71126414|NCT01972789|141758886|OTHER||Odds Ratio (OR)|-21.39||||0.054|TWO_SIDED|95.0|-43.17|0.39|||Mixed Models Analysis|||||0.39|-43.17|0.054
71089525|NCT00427934|141685541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.7||90.0|-1.7|1.06||This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||1.06|-1.70|0.700
71089526|NCT00427934|141685541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.799||90.0|-1.45|1.97||This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||1.97|-1.45|0.799
71089527|NCT00427934|141685541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.867||90.0|-1.35|1.66||This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||1.66|-1.35|0.867
71089528|NCT00427934|141685541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.45||||0.167||90.0|-3.17|0.28||This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||0.28|-3.17|0.167
71089529|NCT00427934|141685541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.966||90.0|-1.91|1.81||This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||1.81|-1.91|0.966
71089530|NCT00427934|141685542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.925||90.0|-6.41|5.72||This analysis was carried out using ANCOVA with baseline patient's assessment of arthritis pain as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||5.72|-6.41|0.925
71126415|NCT01972789|141758887|OTHER||Negative Binomial Regression|1.11||||0.001|TWO_SIDED|95.0|1.04|1.18|||Mixed Model|||||1.18|1.04|0.001
71126416|NCT01972789|141758888|OTHER||Odds Ratio (OR)|0.26||||0.338|TWO_SIDED|95.0|-0.28|0.8|||Mixed Models Analysis|||||0.80|-0.28|0.338
71126417|NCT01972789|141758889|OTHER||Odds Ratio (OR)|1.44||||0.284|TWO_SIDED|95.0|0.74|2.8|||Regression, Logistic|||Month 12||2.80|0.74|0.284
71126418|NCT01972789|141758889|OTHER||Odds Ratio (OR)|1.29||||0.407|TWO_SIDED|95.0|0.71|2.33|||Regression, Logistic|||Month 24||2.33|0.71|0.407
70857821|NCT03274999|141201705|SUPERIORITY|||||||0.134||||||Pre-blink, T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.134
70857822|NCT03274999|141201705|SUPERIORITY|||||||0.315||||||Pre-blink, T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.315
70857823|NCT03274999|141201705|SUPERIORITY|||||||0.071||||||Pre-blink, T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.071
70857824|NCT03274999|141201705|SUPERIORITY|||||||0.26||||||Pre-blink, T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.260
70857825|NCT03274999|141201705|SUPERIORITY|||||||0.264||||||Pre-blink, T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.264
71089531|NCT00427934|141685542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.26||||0.239||90.0|-12.62|2.11||This analysis was carried out using ANCOVA with baseline patient's assessment of arthritis pain as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||2.11|-12.62|0.239
71126419|NCT01972789|141758890|OTHER||Odds Ratio (OR)|0.35||||0.217|TWO_SIDED|95.0|0.12|1.04|||Regression, Logistic|||||1.04|0.12|0.217
71126420|NCT01972789|141758891|OTHER||Odds Ratio (OR)|0.84||||0.615|TWO_SIDED|95.0|0.42|1.66|||Regression, Logistic|||||1.66|0.42|0.615
71126421|NCT01972789|141758892|OTHER||Odds Ratio (OR)|1.08||||0.819|TWO_SIDED|95.0|0.54|2.18|||Regression, Logistic|||||2.18|0.54|0.819
70946379|NCT00551135|141392986|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3382|TWO_SIDED||||||ANOVA|||Magnification change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3382
70946380|NCT00551135|141392986|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043|TWO_SIDED||||||ANOVA|||Helplessness change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0430
70946381|NCT00551135|141392986|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1128|TWO_SIDED||||||ANOVA|||Helplessness change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1128
70857826|NCT03274999|141201705|SUPERIORITY|||||||0.381||||||Pre-blink, T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.381
70946382|NCT00551135|141392986|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0632|TWO_SIDED||||||ANOVA|||Helplessness change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0632
70946383|NCT00551135|141392986|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8667|TWO_SIDED||||||ANOVA|||Helplessness change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8667
70946384|NCT00551135|141392986|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6365|TWO_SIDED||||||ANOVA|||Helplessness change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6365
71126422|NCT01972789|141758894|OTHER||Odds Ratio (OR)|4.32||||0.565|TWO_SIDED|95.0|0.03|630.5|||Regression, Logistic|||||630.5|0.03|0.565
71126423|NCT01972789|141758895|OTHER||Odds Ratio (OR)|1.39||||0.034|TWO_SIDED|95.0|1.03|1.9|||Regression, Logistic|||||1.90|1.03|0.034
71126424|NCT03268941|141758906|OTHER||Least Square (LS) Mean Difference|7.38|||<|0.001|TWO_SIDED|95.0|4.03|13.52||ANCOVA model was used for analysis. Treatment, underlying disease (DG/IG) were fixed factors. ln of baseline prolactin concentration as covariate, ln of ratio of Cmax to baseline concentration as response. Results in original scale are presented.|ANCOVA|||Change in serum prolactin on Day 1 at the Tmax as a ratio of Cmax to serum prolactin concentration at Baseline.||13.52|4.03|<0.001
71126425|NCT03268941|141758906|OTHER||LS Mean Difference|11.24|||<|0.001|TWO_SIDED|95.0|5.91|21.41||ANCOVA model was used for analysis. Treatment, underlying disease (DG/IG) were fixed factors. ln of baseline prolactin concentration as covariate, ln of ratio of Cmax to baseline concentration as response. Results in original scale are presented.|ANCOVA|||Change in serum prolactin on Day 1 at the Tmax as a ratio of Cmax to serum prolactin concentration at Baseline.||21.41|5.91|<0.001
70857827|NCT03274999|141201705|SUPERIORITY|||||||0.249||||||Pre-blink, T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.249
71126426|NCT03268941|141758906|OTHER||LS Mean Difference|12.8|||<|0.001|TWO_SIDED|95.0|6.94|23.59||ANCOVA model was used for analysis. Treatment, underlying disease (DG/IG) were fixed factors. ln of baseline prolactin concentration - covariate, ln of ratio of Cmax to baseline concentration as response. Results in original scale are presented.|ANCOVA|||Change in serum prolactin on Day 1 at the Tmax as a ratio of Cmax to serum prolactin concentration at Baseline.||23.59|6.94|<0.001
71126427|NCT03268941|141758907|OTHER||LS Mean Difference|7.76|STANDARD_ERROR_OF_MEAN|14.648||0.599|TWO_SIDED|95.0|-21.89|37.41||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 7 in Part 1.||37.41|-21.89|0.599
71126428|NCT03268941|141758907|OTHER||LS Mean Difference|6.28|STANDARD_ERROR_OF_MEAN|15.469||0.687|TWO_SIDED|95.0|-25.04|37.59||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 7 in Part 1.||37.59|-25.04|0.687
71126429|NCT03268941|141758907|OTHER||LS Mean Difference|8.05|STANDARD_ERROR_OF_MEAN|15.45||0.605|TWO_SIDED|95.0|-23.22|39.33||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 7 in Part 1.||39.33|-23.22|0.605
71126430|NCT03268941|141758908|OTHER||LS Mean Difference|7.56|STANDARD_ERROR_OF_MEAN|11.708||0.522|TWO_SIDED|95.0|-16.06|31.19||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 1 in Part 1.||31.19|-16.06|0.522
71126431|NCT03268941|141758908|OTHER||LS Mean Difference|12.92|STANDARD_ERROR_OF_MEAN|12.143||0.293|TWO_SIDED|95.0|-11.58|37.43||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 1 in Part 1.||37.43|-11.58|0.293
71126432|NCT03268941|141758908|OTHER||LS Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|11.654||0.551|TWO_SIDED|95.0|-16.52|30.52||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 1 in Part 1.||30.52|-16.52|0.551
71126433|NCT03268941|141758909|OTHER||Hodges-Lehmann Estimate of Median Diff|-18.14||||0.274|TWO_SIDED|95.0|-307.58|13.56||P-value was obtained with pairwise Wilcoxon Rank Sum tests.|Wilcoxon Rank Sum tests|||Percent Change in GE time measured by the SmartPill on Day 7 in Part 1.||13.56|-307.58|0.274
71089532|NCT00427934|141685542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73||||0.872||90.0|-6.79|8.25||This analysis was carried out using ANCOVA with baseline patient's assessment of arthritis pain as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||8.25|-6.79|0.872
71089533|NCT00427934|141685542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63||||0.745||90.0|-9.91|6.65||This analysis was carried out using ANCOVA with baseline patient's assessment of arthritis pain as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||6.65|-9.91|0.745
71089534|NCT00427934|141685542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.22||||0.644||90.0|-10.14|5.71||This analysis was carried out using ANCOVA with baseline patient's assessment of arthritis pain as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||5.71|-10.14|0.644
71089535|NCT00427934|141685543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.36||||0.524||90.0|-8.49|3.77||This analysis was carried out using ANCOVA with baseline Patient's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||3.77|-8.49|0.524
71089536|NCT00427934|141685543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.96||||0.338||90.0|-10.8|2.87||This analysis was carried out using ANCOVA with baseline Patient's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||2.87|-10.80|0.338
71089537|NCT00427934|141685543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98||||0.83||90.0|-8.55|6.58||This analysis was carried out using ANCOVA with baseline Patient's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||6.58|-8.55|0.830
71089538|NCT00427934|141685543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.68||||0.118||90.0|-15.76|0.4||This analysis was carried out using ANCOVA with baseline Patient's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||0.40|-15.76|0.118
71089539|NCT00427934|141685543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.78||||0.712||90.0|-9.73|6.18||This analysis was carried out using ANCOVA with baseline Patient's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||6.18|-9.73|0.712
71089540|NCT00427934|141685544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.54||90.0|-0.28|0.13||This analysis was carried out using ANCOVA with baseline Physician's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||0.13|-0.28|0.540
71089541|NCT00427934|141685544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.757||90.0|-0.28|0.19||This analysis was carried out using ANCOVA with baseline Physician's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||0.19|-0.28|0.757
71089542|NCT00427934|141685544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.767||90.0|-0.31|0.21||This analysis was carried out using ANCOVA with baseline Physician's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||0.21|-0.31|0.767
71089543|NCT00427934|141685544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.112||90.0|-0.52|0.01||This analysis was carried out using ANCOVA with baseline Physician's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||0.01|-0.52|0.112
71089544|NCT00427934|141685544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.49||90.0|-0.42|0.17||This analysis was carried out using ANCOVA with baseline Physician's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||0.17|-0.42|0.490
71089545|NCT00427934|141685545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.464||90.0|-0.19|0.07||This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||0.07|-0.19|0.464
71089546|NCT00427934|141685545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.068||90.0|-0.35|-0.02||This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||-0.02|-0.35|0.068
71089547|NCT00427934|141685545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.532||90.0|-0.23|0.11||This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||0.11|-0.23|0.532
71089548|NCT00427934|141685545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.063||90.0|-0.41|-0.03||This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||-0.03|-0.41|0.063
71089549|NCT00427934|141685545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.396||90.0|-0.36|0.12||This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||0.12|-0.36|0.396
71089550|NCT00427934|141685546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.481||90.0|-7.36|2.96||This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||2.96|-7.36|0.481
70857828|NCT03274999|141201705|SUPERIORITY|||||||0.451||||||Pre-blink, T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.451
70857829|NCT03274999|141201705|SUPERIORITY|||||||0.393||||||Pre-blink, T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.393
70857830|NCT03274999|141201706|SUPERIORITY|||||||0.006||||||Eye-opening, T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.006
70946385|NCT00551135|141392986|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9275|TWO_SIDED||||||ANOVA|||Helplessness change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9275
71126434|NCT03268941|141758909|OTHER||Hodges-Lehmann Estimate of Median Diff|-26.95||||0.481|TWO_SIDED|95.0|-229.73|530.49||P-value was obtained with pairwise Wilcoxon Rank Sum tests.|Wilcoxon Rank Sum tests|||Percent Change in GE time measured by the SmartPill on Day 7 in Part 1.||530.49|-229.73|0.481
71126435|NCT03268941|141758909|OTHER||Hodges-Lehmann Estimate of Median Diff|-24.49||||0.382|TWO_SIDED|95.0|-225.87|98.91||P-value was obtained with pairwise Wilcoxon Rank Sum tests.|Wilcoxon Rank Sum tests|||Percent Change in GE on time measured by the SmartPill Day 7 in Part 1.||98.91|-225.87|0.382
71126436|NCT01216683|141758914|SUPERIORITY|||||||0.02||||||one-sided p-value|Cochran-Mantel-Haenszel|||The study was designed to detect a 16% difference in CR rate from 50% in the Bendamustine + Rituximab arms to 66% in the Bendamustine + Rituximab + Bortezomib arm, with 90% power at the one-sided alpha 0.15 level.||||0.02
71126437|NCT01216683|141758915|SUPERIORITY|||||||0.02|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified on Groupe d'Etude des Lymphomes Folliculaires status and Follicular Lymphoma International Prognostic Index||||||0.02
71126438|NCT03495102|141758974|SUPERIORITY||Mean Difference (Net)|-0.17||||0.003|TWO_SIDED|95.0|-0.29|-0.06|||Mixed Models Analysis|||||-0.06|-0.29|0.003
71126439|NCT03495102|141758974|SUPERIORITY||Mean Difference (Net)|-0.34|||<|0.001|TWO_SIDED|95.0|-0.45|-0.22|||Mixed Models Analysis|||||-0.22|-0.45|<0.001
71126440|NCT03495102|141758975|SUPERIORITY||Mean Difference (Net)|-0.9||||0.001|TWO_SIDED|95.0|-1.4|-0.4|||Mixed Models Analysis|||||-0.4|-1.4|0.001
70857831|NCT03274999|141201706|SUPERIORITY|||||||0.063||||||Eye-opening, T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.063
71126441|NCT03495102|141758975|SUPERIORITY||Mean Difference (Net)|-1.6|||<|0.001|TWO_SIDED|95.0|-2.1|-1.1|||Mixed Models Analysis|||||-1.1|-2.1|<0.001
71126442|NCT03495102|141758976|SUPERIORITY||Odds Ratio (OR)|1.49||||0.006|TWO_SIDED|95.0|1.12|1.98|||Regression, Logistic|||||1.98|1.12|0.006
71126443|NCT03495102|141758976|SUPERIORITY||Odds Ratio (OR)|2.23|||<|0.001|TWO_SIDED|95.0|1.65|3.01|||Regression, Logistic|||||3.01|1.65|<0.001
71126444|NCT03495102|141758977|SUPERIORITY||Mean Difference (Net)|-3.7||||0.084|TWO_SIDED|95.0|-7.8|0.5|||Mixed Models Analysis|||||0.5|-7.8|0.084
71126445|NCT03495102|141758977|SUPERIORITY||Mean Difference (Net)|-8.1|||<|0.001|TWO_SIDED|95.0|-12.3|-3.9|||Mixed Models Analysis|||||-3.9|-12.3|<0.001
71126446|NCT01755455|141759004|SUPERIORITY_OR_OTHER|||||||0.81|||||||Fixed-effect model|||Fixed-effect models accounted for repeated measurements within subjects and treatment sequence. The estimated effect signifies the absolute change from baseline at 6 weeks in the specified outcome measure and (standard error).||||0.81
71126447|NCT01755455|141759005|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fixed-effect model|||||||<0.05
71126448|NCT01755455|141759006|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fixed-effect model|||Fixed-effect models accounted for repeated measurements within subjects and treatment sequence. The estimated effect signifies the absolute change from baseline at 6 weeks in the specified outcome measure and (standard error).||||<0.05
71126449|NCT01755455|141759007|SUPERIORITY_OR_OTHER|||||||0.16|||||||Fixed-effect model|||||||0.16
71126450|NCT03464019|141759014|SUPERIORITY||Hazard Ratio (HR)|1.086||||0.1212|TWO_SIDED|95.0|0.726|1.623|||Peto-Peto test|||In Part 1, participants who converted following medical assistance were censored at the time of conversion after medical assistance. Participants who presented missing data from time t to the end were censored at the time of last available data. Participants who did not convert or were not censored before 5 hours were censored at 5 hours.||1.623|0.726|0.1212
71126451|NCT03464019|141759014|SUPERIORITY||Hazard Ratio (HR)|2.857|||<|0.001|TWO_SIDED|95.0|1.868|4.371||The threshold for statistical significance was p \< 0.05.|Wilcoxon|||In Parts 2 and 3, participants converting after additional medication interventions were censored after the end of the observation period.||4.371|1.868|<0.001
71126452|NCT00511134|141759015|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Descriptive data|||It was hypothesized that the Zyban+Lunesta group would report lower ISI scores at end of trial than the Zyban+Placebo group.||||<0.05
71126453|NCT00511134|141759016|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Fisher Exact|Degrees of freedom=1||It is predicted that subjects taking eszopiclone will be more likely to report abstinence at trial endpoint than those taking placebo.||||<0.05
71126454|NCT00528801|141759064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|2.07||0.008||95.0|||||Mixed Models Analysis|Adjusted for gender, age, and education.|Cases are lower than controls.|Null hypothesis is no difference between cases and controls in the WAIS-III Perormance IQ (PIQ) Index. A linear model controlling for gender, age, and education was used to compare controls versus cases using an F statistic. Based on sample-size calculations, 120 patients and 36 controls were needed to have 80% power to detect an 8-point difference on the WAIS-III PIQ Index.||||0.008
71126455|NCT00528801|141759065|SUPERIORITY_OR_OTHER||Difference in proportions|0.11||||0.048||95.0|0.026|0.199|||Fisher Exact|||Null hypothesis is no difference between cases and controls in the proportion of subjects with lacunae. This was tested using a Fisher's Exact Test.||.199|.026|0.048
71089551|NCT00427934|141685546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.33||||0.698||90.0|-4.34|6.99||This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||6.99|-4.34|0.698
70857832|NCT03274999|141201706|SUPERIORITY|||||||0.005||||||Eye-opening, T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.005
70857833|NCT03274999|141201706|SUPERIORITY|||||||0.089||||||Eye-opening, T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.089
71089552|NCT00427934|141685546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.65||||0.233||90.0|-1.79|11.1||This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||11.10|-1.79|0.233
71089553|NCT00427934|141685546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.48||||0.32||90.0|-2.29|9.25||This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||9.25|-2.29|0.320
70857834|NCT03274999|141201706|SUPERIORITY|||||||0.112||||||Eye-opening, T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.112
70857835|NCT03274999|141201706|SUPERIORITY|||||||0.16||||||Eye-opening, T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.16
71089554|NCT00427934|141685546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.912||90.0|-5.81|6.64||This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||6.64|-5.81|0.912
71089555|NCT00427934|141685547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.653||90.0|-0.31|0.18||This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.|ANCOVA|||Week 1||0.18|-0.31|0.653
71089556|NCT00427934|141685547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.703||90.0|-0.41|0.26||This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.|ANCOVA|||Week 2||0.26|-0.41|0.703
71089557|NCT00427934|141685547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.968||90.0|-0.37|0.39||This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.|ANCOVA|||Week 4||0.39|-0.37|0.968
71089558|NCT00427934|141685547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.21||90.0|-0.72|0.1||This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.|ANCOVA|||Week 8||0.10|-0.72|0.210
71089559|NCT00427934|141685547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.696||90.0|-0.53|0.33||This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.|ANCOVA|||Week 12||0.33|-0.53|0.696
71089560|NCT00427934|141685549|SUPERIORITY_OR_OTHER||Percentage Difference|9.09||||0.155||90.0|-6.16|21.83||p-value (one-sided) was based on Barnard exact test if more than 20% of expected cell counts were \< 5 otherwise Pearson chi-square test.|Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|||21.83|-6.16|0.155
71089561|NCT00427934|141685555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57||||0.698||90.0|-1.87|3.01||This analysis was carried out ANCOVA with baseline SF-36 score as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||3.01|-1.87|0.698
71089562|NCT00427934|141685555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.68||||0.344||90.0|-4.62|1.26||This analysis was carried out ANCOVA with baseline SF-36 score as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||1.26|-4.62|0.344
71089563|NCT00427934|141685556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.734||90.0|-2.71|4.11||This analysis was carried out ANCOVA with baseline SF-36 score as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||4.11|-2.71|0.734
71089564|NCT00427934|141685556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56||||0.818||90.0|-3.5|4.62||This analysis was carried out ANCOVA with baseline SF-36 score as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||4.62|-3.50|0.818
71089565|NCT00427934|141685557|SUPERIORITY_OR_OTHER|||||||0.649||95.0|||||Fisher Exact|||||||0.649
71089566|NCT00427934|141685558|SUPERIORITY_OR_OTHER|||||||0.9826||95.0|||||Log Rank|||||||0.9826
71089567|NCT04539275|141685566|SUPERIORITY||Risk Difference (RD)|-0.01||||1|TWO_SIDED|95.0|-0.15|0.14|||Fisher Exact|||||0.14|-0.15|1.00
71089568|NCT04539275|141685567|SUPERIORITY||Improvement Rate Ratio|1.08||||0.749|TWO_SIDED|95.0|0.65|1.78|||Log Rank|||||1.78|0.65|0.749
71089569|NCT04539275|141685568|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.943|TWO_SIDED|95.0|0.21|4.23|||Log Rank|||||4.23|0.21|0.943
71089570|NCT04539275|141685569|SUPERIORITY||Risk Difference (RD)|-0.08||||0.4014|TWO_SIDED|95.0|-0.25|0.1|||Chi-squared|||||0.10|-0.25|0.4014
71089571|NCT04539275|141685570|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.3762|TWO_SIDED|95.0|0.18|1.96|||Log Rank|||||1.96|0.18|0.3762
71089572|NCT04539275|141685571|SUPERIORITY||Risk Difference (RD)|-0.04||||0.6867|TWO_SIDED|95.0|-0.17|0.09|||Fisher Exact|||||0.09|-0.17|0.6867
71089573|NCT04539275|141685572|SUPERIORITY||Improvement Rate Ratio|1.11||||0.6494|TWO_SIDED|95.0|0.68|1.83|||Log Rank|||||1.83|0.68|0.6494
71089574|NCT04539275|141685573|SUPERIORITY||Improvement Rate Ratio|0.98||||0.9338|TWO_SIDED|95.0|0.59|1.63|||Log Rank|||||1.63|0.59|0.9338
71089575|NCT04539275|141685577|SUPERIORITY||Improvement Rate Ratio|1.14||||0.5682|TWO_SIDED|95.0|0.7|1.86|||Log Rank|||||1.86|0.70|0.5682
71089576|NCT04539275|141685579|SUPERIORITY||Median Difference (Final Values)|0.0||||0.8642|TWO_SIDED|95.0|-2.3|2.3|||Wilcoxon (Mann-Whitney)|||||2.3|-2.3|0.8642
71089577|NCT01373164|141685582|SUPERIORITY|The planned primary analysis for this study utilized a Bayesian exponential-likelihood model, incorporating historical overall survival (OS) data from 2 studies (Oettle et al. 2005; Saif et al. 2009). The primary analysis was performed using strong borrowing from the historical data. The model was estimated to borrow approximately 37 events from the historical studies.|Hazard Ratio (HR)|0.794|||||TWO_SIDED|95.0|0.59|1.085|||Bayesian Analysis|Primary comparison was to be considered successful if there was at least 0.85 posterior probability that the hazard ratio (HR) for OS of LY+Gem is \<1.|This is a Credible Interval estimated from the Bayesian analysis.|||1.085|0.590|
71089578|NCT01799941|141685595|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||The primary analysis tested the null hypothesis that the mean change in CNS-LS score from Baseline to Day 90 visit is equal to zero.||||<0.0001
71089579|NCT01799941|141685595|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||one-sample t-test|||The primary analysis tested the null hypothesis that the mean change in CNS-LS score from Baseline to Day 90 visit is equal to zero.||||<0.0001
71089580|NCT01799941|141685595|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||The primary analysis tested the null hypothesis that the mean change in CNS-LS score from Baseline to Day 90 visit is equal to zero.||||<0.0001
71089581|NCT01799941|141685595|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||The primary analysis tested the null hypothesis that the mean change in CNS-LS score from Baseline to Day 90 visit is equal to zero.||||<0.0001
71089582|NCT01799941|141685595|SUPERIORITY_OR_OTHER||Analysis of covariance (ANCOVA)|0.04|STANDARD_ERROR_OF_MEAN|0.72|||TWO_SIDED|95.0|-1.37|1.45|||||A positive estimate indicates a smaller change in the first group. Observations used =261.|||1.45|-1.37|
71126456|NCT00344500|141759067|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Predicted trajectory of mean weight change between matched UC and LB subjects over 12 months (treatment\*time interaction: F(1,1275)=68.75, p\<.01).||General Linear Mixed Model (GLMM) used to illustrate the magnitude of difference between slopes for major outcomes for two hypothetical participants with identical baseline characteristics over 12 months.||||<0.01
71126457|NCT00680797|141759071|SUPERIORITY_OR_OTHER|||||||0.023|TWO_SIDED|||||Comparison of pre- to post-intervention insulin levels between the groups receiving E only versus the group receiving no hormone replacement.|ANCOVA|||The major outcome variable being presented is changes in insulin levels. Changes in insulin levels were analyzed using an ANCOVA model that adjusted for baseline insulin and age.||||0.023
71126458|NCT00680797|141759071|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED|||||Comparison in the change in insulin levels between the groups receiving E with or without T.|ANCOVA|||The major outcome variable being presented is changes in insulin levels. Changes in insulin levels were analyzed using an ANCOVA model that adjusted for baseline insulin and age.||||0.042
71089583|NCT01799941|141685595|SUPERIORITY_OR_OTHER||ANCOVA|1.11|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|95.0|-0.46|2.68|||||A positive estimate indicates a smaller change in the first group. Observations used =261.|||2.68|-0.46|
71126459|NCT02596230|141759097|OTHER||Hazard Ratio (HR)|0.634||||0.188|TWO_SIDED|95.0|0.322|1.249||One-side p-value|Regression, Cox|Cox-regression proportional hazards model including fixed effects for treatment.|Hazard Ratio \< 1 favors Dabigatran etexilate.|||1.249|0.322|0.188
71126460|NCT02596230|141759098|OTHER||Hazard Ratio (HR)|0.778||||0.606|TWO_SIDED|95.0|0.3|2.017||One-side p-value|Regression, Cox|Cox-regression proportional hazards model including fixed effects for treatment.|Hazard Ratio \< 1 favors Dabigatran etexilate.|||2.017|0.300|0.606
71089584|NCT01799941|141685595|SUPERIORITY_OR_OTHER||ANCOVA|1.15|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|95.0|-0.39|2.69|||||A positive estimate indicates a smaller change in the first group. Observations used =261.|||2.69|-0.39|
71089585|NCT01799941|141685596|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
71089586|NCT01799941|141685596|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
71089587|NCT01799941|141685596|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
71089588|NCT01799941|141685596|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
71089589|NCT01799941|141685597|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 30 versus Baseline||||<0.0001
71089590|NCT01799941|141685597|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 90 versus Baseline||||<0.0001
71089591|NCT01799941|141685597|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 30 versus Baseline||||<0.0001
71126461|NCT02596230|141759099|OTHER||Hazard Ratio (HR)|0.751||||0.542|TWO_SIDED|95.0|0.299|1.885||One-side p-value|Regression, Cox|Cox-regression proportional hazards model including fixed effects for treatment.|Hazard Ratio \< 1 favors Dabigatran etexilate.|||1.885|0.299|0.542
71126462|NCT02596230|141759100|OTHER||Hazard Ratio (HR)|0.0||||0.996|TWO_SIDED|95.0||||One-side p-value|Regression, Cox|Cox-regression proportional hazards model including fixed effects for treatment.|"Hazard Ratio \< 1 favors Dabigatran etexilate.~Hazard Ratio is actually \<0.01~95% Confidence Interval is not calculable (NA) due to insufficient number of participants with events."|||||0.996
71126463|NCT02596230|141759101|OTHER||Hazard Ratio (HR)|0.857||||0.69|TWO_SIDED|95.0|0.402|1.828||One-side p-value|Regression, Cox|Cox-regression proportional hazards model including fixed effects for treatment.|Hazard Ratio \< 1 favors Dabigatran etexilate.|||1.828|0.402|0.690
71126464|NCT01716104|141759125|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|||||||0.0005
71126465|NCT01716104|141759126|SUPERIORITY|||||||0.035|||||||Mixed Models Analysis|||||||0.035
71126466|NCT01716104|141759127|SUPERIORITY|||||||0.0008|||||||Mixed Models Analysis|||||||0.0008
71126467|NCT01716104|141759128|SUPERIORITY|||||||0.0011|||||||Mixed Models Analysis|||||||0.0011
71126468|NCT01716104|141759129|SUPERIORITY|||||||0.0054|||||||Mixed Models Analysis|||||||0.0054
71126469|NCT01716104|141759130|SUPERIORITY|||||||0.0437|||||||Mixed Models Analysis|||||||0.0437
71126470|NCT01716104|141759131|SUPERIORITY|||||||0.0862|||||||Mixed Models Analysis|||||||0.0862
71126471|NCT01716104|141759132|SUPERIORITY|||||||0.0621|||||||Mixed Models Analysis|||||||0.0621
71126472|NCT01716104|141759133|SUPERIORITY|||||||0.0142|||||||Mixed Models Analysis|||||||0.0142
71126473|NCT03836677|141759163|OTHER||Geometric Mean ratio to baseline|1.72|||<|0.0001|TWO_SIDED|95.0|1.38|2.13||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment.|t-test, 2 sided|Within-group comparison to baseline using paired test||||2.13|1.38|<0.0001
71126474|NCT03836677|141759163|OTHER||Geometric mean ratio to baseline|1.53|||<|0.0001|TWO_SIDED|95.0|1.28|1.83||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment.|t-test, 2 sided|Within-group comparison to baseline using paired test.||||1.83|1.28|<0.0001
71126475|NCT03836677|141759164|OTHER||Geometric mean ratio to baseline|0.5|||<|0.0001|TWO_SIDED|95.0|0.39|0.63||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment.|t-test, 2 sided|Within-group comparison to baseline using paired test||||0.63|0.39|<0.0001
71126476|NCT03836677|141759164|OTHER||Geometric mean ratio to baseline|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.67||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment.|t-test, 2 sided|Within-group comparison to baseline using paired test||||0.67|0.40|<0.0001
70946386|NCT00551135|141392988|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2136|TWO_SIDED||||||ANOVA|||PCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.2136
71126477|NCT03836677|141759165|OTHER||Geometric mean ratio to baseline|1.7|||<|0.0001||95.0|1.37|2.11|||t-test, 2 sided|Within-group comparison to baseline using paired test||||2.11|1.37|<0.0001
71126478|NCT03836677|141759165|OTHER||Geometric mean ratio to baseline|1.51||||0.0001|TWO_SIDED|95.0|1.26|1.8|||t-test, 2 sided|Within-group comparison to baseline using paired test||||1.80|1.26|0.0001
71126479|NCT03836677|141759166|OTHER||Geometric mean ratio to baseline|0.5|||<|0.0001|TWO_SIDED|95.0|0.4|0.63|||t-test, 2 sided|Within-group comparison to baseline using paired test||||0.63|0.40|<0.0001
71126480|NCT03836677|141759166|OTHER||Geometric mean ratio to baseline|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.68|||t-test, 2 sided|Within-group comparison to baseline using paired test||||0.68|0.40|<0.0001
71126481|NCT03836677|141759167|OTHER||Mean Change from Baseline|0.346||||0.0003|TWO_SIDED|95.0|0.182|0.509|||t-test, 2 sided|Within-group comparison to baseline using paired test.||||0.509|0.182|0.0003
71126482|NCT03836677|141759167|OTHER||Mean Change from Baseline|0.273||||0.0004|TWO_SIDED|95.0|0.14|0.405|||t-test, 2 sided|Within-group comparison to baseline using paired test.||||0.405|0.140|0.0004
71126483|NCT03836677|141759168|OTHER||Mean ratio to baseline|-0.28||||0.2515|TWO_SIDED|95.0|-0.77|0.21|||t-test, 2 sided|Within-group comparison to baseline using paired test.||||0.21|-0.77|0.2515
71126484|NCT03836677|141759168|OTHER||Mean ratio to baseline|-0.5||||0.004|TWO_SIDED|95.0|-0.81|-0.18|||t-test, 2 sided|Within-group comparison to baseline using paired test.||||-0.18|-0.81|0.0040
71126485|NCT03249103|141759182|OTHER|||||||0.032|||||||t-test, 2 sided|||placebo - NYX-2925 20 mg||||0.032
71126486|NCT03249103|141759183|OTHER|||||||0.039|||||||t-test, 2 sided|||placebo - NYX-2925 200 mg||||0.039
71126487|NCT03249103|141759184|OTHER|||||||0.0072|||||||t-test, 2 sided|comparing Week 2 (Placebo) to Week 6 (NYX-2925 200 mg)||||||0.0072
71126488|NCT02428413|141759185|SUPERIORITY_OR_OTHER|||||||0.24|||||||t-test, 2 sided|||||||0.24
71126489|NCT02428413|141759186|SUPERIORITY_OR_OTHER|||||||0.26|||||||t-test, 2 sided|||||||0.26
71126490|NCT02025439|141759189|OTHER||Mean Difference (Final Values)|0.071|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71126491|NCT03688100|141759194|SUPERIORITY||ratio of means|0.62||||0.005|TWO_SIDED|95.0|0.45|0.86||The a priori threshold for statistical significance is p\<0.05.|Zero Inflated Poisson (ZIP) Model||For the ratio of means, BA is the numerator and MEDS is the denominator.|Emergency Department visits AT 3 MONTHS||0.86|0.45|0.005
70857836|NCT03274999|141201706|SUPERIORITY|||||||0.077||||||Eye-opening, T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.077
70946387|NCT00551135|141392988|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0094|TWO_SIDED||||||ANOVA|||PCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.0094
71126492|NCT03688100|141759194|SUPERIORITY||ratio of means|0.7||||0.008|TWO_SIDED|95.0|0.6|0.86||The a priori threshold for statistical significance is p\<0.05|Zero Inflated Poisson (ZIP) Model||For the ratio of means for ED visits, BA is the numerator and MEDS is the denominator.|Emergency Department visits AT 6 MONTHS||0.86|0.60|0.008
71126493|NCT03688100|141759194|SUPERIORITY||ratio of means|0.73||||0.0001|TWO_SIDED|95.0|0.62|0.85||The a priori threshold for statistical significance is p\<0.05.|Zero Inflated Poisson (ZIP) Model||For the ratio of means for ED visits , BA is numerator and MEDS is the denominator.|Emergency Department visits AT 12 MONTHS||0.85|0.62|0.0001
71126494|NCT03688100|141759195|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is p\<0.05.|Zero Inflated Poisson (ZIP) Model|||Differences in the number of hospital readmissions between BA and MEDS at 3, 6, and 12 months||||>0.05
71126495|NCT03688100|141759196|SUPERIORITY||ratio of means|0.83||||0.002|TWO_SIDED|95.0|0.75|0.92||The a priori threshold for statistical significance is p\<0.05.|Zero Inflated Poisson (ZIP) Model||For the ratio of means, BA is the numerator and MEDS is the denominator.|Days in the Hospital at 3 months||0.92|0.75|0.002
71126496|NCT03688100|141759196|SUPERIORITY||ratio of means|0.81||||0.005|TWO_SIDED|95.0|0.75|0.87||The a priori threshold for statistical significance is p\<0.05.|Zero Inflated Poisson (ZIP) Model||For the ratio of means, BA is numerator and MEDS is the denominator.|Days in the Hospital at 6 MONTHS||0.87|0.75|0.005
71126497|NCT03688100|141759196|SUPERIORITY||ratio of means|0.64|||<|0.0001|TWO_SIDED|95.0|0.6|0.68||The a priori threshold for statistical significance is p\<0.05.|Zero Inflated Poisson (ZIP) Model||For the ratio of means, BA is the numerator and MEDS is the denominator.|Days in the Hospital AT 12 MONTHS||0.68|0.60|<0.0001
71126498|NCT03688100|141759197|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is p\<0.05.|Kaplan Meier survival plots|||||||>0.05
71126499|NCT01786252|141759198|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|Sidak-multiple comparison test was performed to detect significant differences between groups.||Statistical analysis to compare differences between endometrial glandular and stromal dating within the vehicle group.||||<0.05
71126500|NCT01786252|141759198|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|Sidak-multiple comparison test was performed to detect significant differences between groups.||Statistical analysis to compare differences between endometrial glandular and stromal dating within the hCG group.||||>0.05
71126501|NCT01786252|141759198|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANOVA|Sidak-multiple comparison test was performed to detect significant differences between groups.||Statistical analysis to compare stromal staging between hCG and IVF media group.||||<0.01
71126502|NCT01786252|141759198|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|Sidak-multiple comparison test was performed to detect significant differences between groups.||Statistical analysis to compare differences between endometrial glandular dating between hCG and IVF media groups.||||>0.05
71126503|NCT01786252|141759199|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71126504|NCT01786252|141759200|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71126505|NCT01786252|141759201|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71126506|NCT02437084|141759229|OTHER|||||||0.01|||||||Paired samples t test, 2 sided|SSPG concentration was log-transformed for statistical analysis; degrees of freedom = 69||Null hypothesis: There will be no change in steady-state plasma glucose (SSPG) concentration after treatment with atorvastatin 40 mg daily for 9 - 10 weeks.||||0.01
71126507|NCT02437084|141759230|OTHER||||||<|0.001|||||||Paired samples t test, 2 sided|Insulin secretion rate AUC was log-transformed for statistical analysis; degrees of freedom = 63.||Null hypothesis: There will be no change in insulin secretion rate AUC after treatment with atorvastatin 40 mg daily for 9 - 10 weeks.||||<0.001
71126508|NCT02437084|141759231|OTHER|||||||0.1|||||||Paired samples t test, 2 sided|Degrees of freedom = 70||Null hypothesis: There will be no change in fasting plasma glucose concentration after treatment with atorvastatin 40 mg daily for 8 - 10 weeks.||||0.10
71126509|NCT02437084|141759232|OTHER|||||||0.01|||||||Paired samples t test, 2 sided|Fasting plasma insulin concentration was log-transformed for statistical analysis; degrees of freedom = 68||Null hypothesis: There will be no change in fasting plasma insulin concentration after treatment with atorvastatin 40 mg daily for 8 - 10 weeks.||||0.01
71126510|NCT02437084|141759233|OTHER|||||||0.03|||||||Paired samples t test, 2 sided|Degrees of freedom = 70||Null hypothesis: There will be no change in OGTT glucose AUC after treatment with atorvastatin 40 mg daily for 8 - 10 weeks.||||0.03
70946388|NCT00551135|141392988|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2131|TWO_SIDED||||||ANOVA|||PCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.2131
71126511|NCT02437084|141759234|OTHER|||||||0.27|||||||Paired samples t test, 2 sided|OGTT insulin AUC was log-transformed for statistical analysis; degrees of freedom = 63||Null hypothesis: There will be no change in OGTT insulin AUC after treatment with atorvastatin 40 mg daily for 8 weeks.||||0.27
71126512|NCT04566692|141759258|NON_INFERIORITY|The bi-weekly treatment was considered non-inferior to the weekly treatment if the lower bound of the 90% CI was \> 0.8.|GLSM Ratio|1.035|||||TWO_SIDED|90.0|1.003|1.0685||||||Geometric least-squares means (GLSMs), GLSM ratio, and 90% CI of GLSM ratio were determined from a mixed-effect model for the log-transformed parameter value with treatment period (weekly or bi-weekly) as a fixed effect and participant as a random effect.||1.0685|1.0030|
70857837|NCT03274999|141201706|SUPERIORITY|||||||0.157||||||Eye-opening, T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.157
70857838|NCT03274999|141201706|SUPERIORITY|||||||0.111||||||Eye-opening, T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.111
70857839|NCT03274999|141201706|SUPERIORITY|||||||0.04||||||Pre-blink, T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.040
71089592|NCT01799941|141685597|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 90 assessment||||<0.0001
71089593|NCT01799941|141685597|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 30 versus Baseline||||<0.0001
71126513|NCT04566692|141759261|NON_INFERIORITY|The biweekly treatment was considered non-inferior to the weekly treatment if the lower bound of the 90% CI was \> 0.8.|GLSM Ratio|0.97|||||TWO_SIDED|90.0|0.9447|0.9957||||||GLSMs, GLSM ratio, and 90% CI of GLSM ratio were determined from a mixed-effect model for the log-transformed parameter value with treatment period (weekly or bi-weekly) as a fixed effect and participants as a random effect.||0.9957|0.9447|
71126514|NCT00377364|141759298|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||Baseline RAVLT scores used as covariate.||||<0.05
71126515|NCT00377364|141759301|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|Baseline ISS scores used as a covariate. ANCOVA results were not significant.||||||<0.05
71126516|NCT00377364|141759302|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||Baseline HRSD scores used as a covariate.||||<0.05
71126517|NCT00377364|141759304|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|Baseline YMRS scores used as a covariate.||||||0.05
71126518|NCT00377364|141759306|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|Baseline ACQ scores used as a covariate.||||||<0.05
71126519|NCT02540265|141759309|OTHER||Effect Size|1.01|||||TWO_SIDED|||||||||||||
70946389|NCT00551135|141392988|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3245|TWO_SIDED||||||ANOVA|||PCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.3245
71126520|NCT02540265|141759309|OTHER||Effect Size|0.87|||||TWO_SIDED|||||||||||||
71126521|NCT02540265|141759310|SUPERIORITY|||||||0.0049|||||||t-test, 2 sided|||||||0.0049
71126522|NCT02540265|141759310|SUPERIORITY|||||||0.0076|||||||t-test, 2 sided|||||||0.0076
71126523|NCT02540265|141759311|SUPERIORITY||||||<|0.05||||||Applies to SPID 0-6, SPID 0-12, SPID 0-24, SPID 12-24, SPID 12-48, and SPID 24-48|t-test, 2 sided|||||||<0.05
71126524|NCT02540265|141759311|SUPERIORITY||||||<|0.05||||||Applies to SPID 0-6, SPID 0-12, SPID 0-24, SPID 12-24, SPID 12-48, and SPID 24-48|t-test, 2 sided|||||||<0.05
71126525|NCT02102399|141759332|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.001
71126526|NCT02102399|141759333|SUPERIORITY_OR_OTHER|||||||0.345|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.345
71126527|NCT02102399|141759334|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Fisher Exact|||||||0.003
71126528|NCT02102399|141759335|SUPERIORITY_OR_OTHER|||||||0.171|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.171
71126529|NCT02102399|141759336|SUPERIORITY_OR_OTHER|||||||0.022|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.022
71126530|NCT02102399|141759337|SUPERIORITY_OR_OTHER|||||||0.451|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.451
71126531|NCT02102399|141759338|SUPERIORITY_OR_OTHER|||||||0.477|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.477
71126532|NCT02102399|141759339|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.007
71126533|NCT02102399|141759340|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.049
71126534|NCT02102399|141759341|SUPERIORITY_OR_OTHER|||||||0.323|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.323
71126535|NCT02102399|141759342|SUPERIORITY_OR_OTHER|||||||0.296|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.296
71126536|NCT02102399|141759343|SUPERIORITY_OR_OTHER|||||||0.776|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.776
71126537|NCT02102399|141759344|SUPERIORITY_OR_OTHER|||||||0.959|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.959
71126538|NCT02102399|141759345|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.76
71126539|NCT02102399|141759346|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.30
71126540|NCT02102399|141759347|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.20
71126541|NCT02102399|141759348|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.77
71126542|NCT02102399|141759349|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.49
71126543|NCT02102399|141759350|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.74
71126544|NCT02102399|141759351|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Fisher Exact|||||||0.120
71126545|NCT02102399|141759352|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Fisher Exact|||||||0.030
71126546|NCT02102399|141759353|SUPERIORITY_OR_OTHER|||||||0.107|TWO_SIDED||||||Fisher Exact|||||||0.107
71126547|NCT03101085|141759354|OTHER|We performed a paired T-test analysis to ascertain whether the COX/CS activity while on S-equol was comparable or different than the COX/CS while on placebo. For each participant, the COX/CS value while on S-equol was subtracted from their COX/CS value while on placebo.|||||>|0.05|||||||Paired T-test|||As the order of the intervention does not matter, all 39 participants who contributed data to the final analysis are included together.||||>0.05
71126548|NCT04583956|141759379|SUPERIORITY||Odds Ratio (OR)|0.98||||0.927|TWO_SIDED|95.0|0.59|1.61|||Proportional odds model||Odds ratio above 1 favors Remdesivir plus Risankizumab.|Includes all ordinal score categories. Odds ratio of a better clinical status score, confidence interval, and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using multiple imputation (MI) for participants lost to follow-up before Day 8 while hospitalized, in hospice, long term acute care, or transferred to other hospital while participants lost to follow-up after discharge to home are assigned a score of 2.||1.61|0.59|0.927
71126549|NCT04583956|141759380|SUPERIORITY||Odds Ratio (OR)|0.9||||0.829|TWO_SIDED|95.0|0.36|2.25|||Regression, Logistic||Odds ratio greater than 1 favors Remdesivir plus Risankizumab.|Odds ratio, confidence interval, and p-value estimated from a logistic regression model adjusted for baseline dexamethasone use, baseline ordinal score, age, and baseline C-Reactive Protein (CRP).||2.25|0.36|0.829
71126550|NCT04583956|141759381|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.399|TWO_SIDED|95.0|0.84|1.56|||Regression, Cox||HR greater than 1 favors Remdesivir plus Risankizumab.|Hazard ratio, confidence interval, and p-value estimated from a Cox model adjusted for baseline steroid use and baseline ordinal score.||1.56|0.84|0.399
70857840|NCT03274999|141201706|SUPERIORITY|||||||0.241||||||Pre-blink, T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.241
70857841|NCT03274999|141201706|SUPERIORITY|||||||0.284||||||Pre-blink, T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.284
70857842|NCT03274999|141201706|SUPERIORITY|||||||0.313||||||Pre-blink, T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.313
70857843|NCT03274999|141201706|SUPERIORITY|||||||0.433||||||Pre-blink, T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.433
71089594|NCT01799941|141685597|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 90 versus Baseline||||<0.0001
71089595|NCT01799941|141685597|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 30 versus Baseline||||<0.0001
71089596|NCT01799941|141685597|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 90 versus Baseline||||<0.0001
71089597|NCT01799941|141685599|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.425|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.407|0.445|||Mixed Effects Poisson Regreesion Model||Number of observations = 854, Number of participants = 298|Day 30 assessment||0.445|0.407|<0.0001
71089598|NCT01799941|141685599|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.277|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.262|0.293|||Mixed Effects Poisson Regression Model||Number of observations = 854, Number of participants = 298|Day 90 assessment||0.293|0.262|<0.0001
71089599|NCT01799941|141685599|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.5|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.469|0.534|||Mixed Effects Poisson Regression Model||Number of observations = 318, Number of participants = 108|Day 30 assessment||0.534|0.469|<0.0001
71089600|NCT01799941|141685599|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.323|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|0.299|0.349|||Mixed Effects Poisson Regression Model||Number of observations = 318, Number of participants = 108|Day 90 assessment||0.349|0.299|<0.0001
71089601|NCT01799941|141685599|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.351|STANDARD_ERROR_OF_MEAN|0.044|<|0.0001|TWO_SIDED|95.0|0.323|0.383|||Mixed Effects Poisson Regression Model||Number of observations = 297, Number of participants = 103|Day 30 assessment||0.383|0.323|<0.0001
71089602|NCT01799941|141685599|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.255|STANDARD_ERROR_OF_MEAN|0.051|<|0.0001|TWO_SIDED|95.0|0.231|0.282|||Mixed Effects Poisson Regression Model||Number of observations = 297, Number of participants = 103|Day 90 assessment||0.282|0.231|<0.0001
71089603|NCT01799941|141685599|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.387|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001|TWO_SIDED|95.0|0.352|0.425|||Mixed Effects Poisson Regression Model||Number of observations = 239, Number of participants = 87|Day 30 assessment||0.425|0.352|<0.0001
71089604|NCT01799941|141685599|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.215|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|0.189|0.245|||Mixed Effects Poisson Regression Model||Number of observations = 239, Number of participants = 87|Day 90 assessment||0.245|0.189|<0.0001
71089605|NCT01799941|141685602|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
71089606|NCT01799941|141685602|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
71089607|NCT01799941|141685602|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
71089608|NCT01799941|141685602|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
71089609|NCT01125930|141685617|SUPERIORITY_OR_OTHER|||||||0.93|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.||||0.93
71089610|NCT01125930|141685618|SUPERIORITY_OR_OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.||||0.79
71089611|NCT01125930|141685619|SUPERIORITY_OR_OTHER|||||||0.94|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.94
71089612|NCT01125930|141685619|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.57
71089613|NCT01125930|141685619|SUPERIORITY_OR_OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.66
71089614|NCT01125930|141685619|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.38
71089615|NCT01125930|141685619|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.24
71089616|NCT01125930|141685620|SUPERIORITY_OR_OTHER|||||||0.87|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess photodamage.||||0.87
71089617|NCT01125930|141685621|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea.||||1.00
71089618|NCT01125930|141685621|SUPERIORITY_OR_OTHER|||||||0.62|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea||||0.62
71089619|NCT01125930|141685621|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea||||1.00
71089620|NCT01125930|141685621|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea||||1.00
71089621|NCT01125930|141685621|SUPERIORITY_OR_OTHER|||||||0.45|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea||||0.45
71089622|NCT01125930|141685622|SUPERIORITY_OR_OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.||||0.53
71089623|NCT01125930|141685622|SUPERIORITY_OR_OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.||||0.53
71089624|NCT01125930|141685622|SUPERIORITY_OR_OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.||||0.53
71126551|NCT04583956|141759382|SUPERIORITY||Odds Ratio (OR)|1.03||||0.91|TWO_SIDED|95.0|0.62|1.71|||Proportional odds model||Odds ratio above 1 favors Remdesivir plus Risankizumab.|Includes all ordinal score categories. Odds ratio of a better clinical status score, confidence interval, and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using last observation carried forward for those lost to follow-up before Day 15 while hospitalized, in hospice, long term acute care, or transferred to other hospital. Participants lost to follow-up before Day 15 after discharge are given a score of 2.||1.71|0.62|0.910
71126552|NCT04583956|141759383|SUPERIORITY||Odds Ratio (OR)|1.14||||0.617|TWO_SIDED|95.0|0.68|1.93|||Proportional odds model||Odds ratio above 1 favors Remdesivir plus Risankizumab.|Includes all ordinal score categories. Odds ratio of a better clinical status score, confidence interval, and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using last observation carried forward for those lost to follow-up before Day 15 while hospitalized, in hospice, long term acute care, or transferred to other hospital. Participants lost to follow-up before Day 15 after discharge are given a score of 2.||1.93|0.68|0.617
71126553|NCT04583956|141759416|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.55|TWO_SIDED|95.0|0.82|1.46|||Regression, Cox||HR greater than 1 favors Remdesivir plus Risankizumab.|Hazard ratio (HR), confidence interval, and p-value estimated from a Cox model adjusted for baseline steroid use and baseline ordinal score.||1.46|0.82|0.550
71089625|NCT01125930|141685622|SUPERIORITY_OR_OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.||||0.53
70857844|NCT03274999|141201706|SUPERIORITY|||||||0.406||||||Pre-blink, T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.406
71089626|NCT01125930|141685622|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.||||1.00
71089627|NCT01125930|141685623|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||1.00
71126554|NCT04583956|141759417|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.523|TWO_SIDED|95.0|0.82|1.48|||Regression, Cox||HR greater than 1 favors Remdesivir plus Risankizumab.|Hazard ratio (HR), confidence interval, and p-value estimated from a Cox model adjusted for baseline steroid use and baseline ordinal score.||1.48|0.82|0.523
71126555|NCT04407234|141759424|SUPERIORITY||Ratio of geometric least squares mean|0.881|||||TWO_SIDED|90.0|0.803|0.967|||Wilcoxon signed rank test|||||0.967|0.803|
71126556|NCT04407234|141759424|SUPERIORITY||Ratio of geometric least squares mean|1.16|||||TWO_SIDED|90.0|1.05|1.28|||Wilcoxon signed rank test|||||1.28|1.05|
71126557|NCT04407234|141759425|SUPERIORITY||Ratio of geometric least squares mean|0.446|||||TWO_SIDED|90.0|0.39|0.509|||Wilcoxon signed rank test|||||0.509|0.390|
70946390|NCT00551135|141392988|SUPERIORITY_OR_OTHER_LEGACY|||||||0.407|TWO_SIDED||||||ANOVA|||PCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.4070
71089628|NCT01125930|141685623|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.41
71126558|NCT04407234|141759425|SUPERIORITY||Ratio of geometric least squares mean|0.679|||||TWO_SIDED|90.0|0.589|0.783|||Wilcoxon signed rank test|||||0.783|0.589|
70857845|NCT03274999|141201706|SUPERIORITY|||||||0.318||||||Pre-blink, T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.318
70946391|NCT00551135|141392988|SUPERIORITY_OR_OTHER_LEGACY|||||||0.349|TWO_SIDED||||||ANOVA|||PCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.3490
71089629|NCT01125930|141685623|SUPERIORITY_OR_OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.66
71089630|NCT01125930|141685623|SUPERIORITY_OR_OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.92
71089631|NCT01125930|141685623|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.80
71126559|NCT04407234|141759427|SUPERIORITY||Ratio of geometricleast squares mean|0.888|||||TWO_SIDED|90.0|0.778|1.01||||||||1.01|0.778|
71126560|NCT04407234|141759427|SUPERIORITY||Ratio of geometricleast squares mean|1.23|||||TWO_SIDED|90.0|1.07|1.42||||||||1.42|1.07|
71126561|NCT04407234|141759428|SUPERIORITY||Ratio of geometricleast squares mean|0.875|||||TWO_SIDED|90.0|0.766|0.999||||||||0.999|0.766|
71126562|NCT04407234|141759428|SUPERIORITY||Ratio of geometricleast squares mean|1.08|||||TWO_SIDED|90.0|0.938|1.25||||||||1.25|0.938|
71126563|NCT04407234|141759429|SUPERIORITY||Ratio of geometricleast squares mean|0.453|||||TWO_SIDED|90.0|0.376|0.545||||||||0.545|0.376|
71126564|NCT04407234|141759429|SUPERIORITY||Ratio of geometricleast squares mean|0.804|||||TWO_SIDED|90.0|0.66|0.979||||||||0.979|0.660|
71126565|NCT04407234|141759430|SUPERIORITY||Ratio of geometricleast squares mean|0.438|||||TWO_SIDED|90.0|0.364|0.527||||||||0.527|0.364|
71126566|NCT04407234|141759430|SUPERIORITY||Ratio of geometricleast squares mean|0.574|||||TWO_SIDED|90.0|0.471|0.698||||||||0.698|0.471|
71126567|NCT00727558|141759431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.554|STANDARD_ERROR_OF_MEAN|0.1943||||97.47|0.1721|0.554|||Mixed Models Analysis||The mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A||0.554|0.1721|
71126568|NCT00727558|141759432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1734|STANDARD_ERROR_OF_MEAN|0.03555||||97.47|-0.1734|-0.1037|||Mixed Models Analysis||Mean difference is narafilcon A minus nelfilcon A|Alternative hypothesis: narafilcon A is superior to nelfilcon A.||-0.1037|-0.1734|
71126569|NCT00727558|141759433|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.3968|STANDARD_ERROR_OF_MEAN|0.1548||||98.7|0.04983|0.3968|||Mixed Models Analysis||The mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A||0.3968|0.04983|
71126570|NCT00727558|141759434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3875|STANDARD_ERROR_OF_MEAN|0.2054||||98.7|0.03714|0.3875|||Mixed Models Analysis||The mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A.||0.3875|0.03714|
71126571|NCT00727558|141759435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6735|STANDARD_ERROR_OF_MEAN|0.1563||||98.7|0.213|0.6735|||Mixed Models Analysis||The mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A||0.6735|0.213|
70857846|NCT03274999|141201706|SUPERIORITY|||||||0.499||||||Pre-blink, T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.499
70946392|NCT00551135|141392988|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1122|TWO_SIDED||||||ANOVA|||MCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.1122
70946393|NCT00551135|141392988|SUPERIORITY_OR_OTHER_LEGACY|||||||0.138|TWO_SIDED||||||ANOVA|||MCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.1380
71089632|NCT01125930|141685624|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of TAC1 at Week 24 visit were made using fold change data.||||0.003
70946394|NCT00551135|141392988|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2023|TWO_SIDED||||||ANOVA|||MCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.2023
71089633|NCT01125930|141685624|SUPERIORITY_OR_OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of CXCR4 at Week 24 visit were made using fold change data.||||0.35
71089634|NCT01125930|141685624|SUPERIORITY_OR_OTHER|||||||0.68|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of CXCL12 at Week 24 visit were made using fold change data.||||0.68
71089635|NCT01125930|141685624|SUPERIORITY_OR_OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of TNFa at Week 24 visit were made using fold change data.||||0.76
71089636|NCT01125930|141685625|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of COL-1 at Week 24 visit were made using fold change data.||||1.00
71089637|NCT01125930|141685625|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of COL-3 at Week 24 visit were made using fold change data.||||0.25
71089638|NCT01125930|141685625|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of MMP-1 at Week 24 visit were made using fold change data.||||0.41
71089639|NCT01125930|141685625|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of MMP-3 at Week 24 visit were made using fold change data.||||0.02
71089640|NCT01125930|141685625|SUPERIORITY_OR_OTHER|||||||0.61|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of MMP-9 at Week 24 visit were made using fold change data.||||0.61
71089641|NCT01125930|141685626|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.||||1.00
71089642|NCT01125930|141685626|SUPERIORITY_OR_OTHER|||||||0.44|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.||||0.44
71089643|NCT01125930|141685626|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.||||0.41
71089644|NCT01125930|141685626|SUPERIORITY_OR_OTHER|||||||0.94|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.||||0.94
71089645|NCT01125930|141685627|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.||||0.15
71089646|NCT01125930|141685628|SUPERIORITY_OR_OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.||||0.13
71089647|NCT01125930|141685629|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Group comparison at Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||1.00
71089648|NCT01125930|141685630|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.||||0.75
71089649|NCT01125930|141685631|SUPERIORITY_OR_OTHER|||||||0.68|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.||||0.68
70857847|NCT03274999|141201706|SUPERIORITY|||||||0.39||||||Pre-blink, T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.390
71089650|NCT01125930|141685632|SUPERIORITY_OR_OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.||||0.77
71089651|NCT01125930|141685633|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.||||0.41
71089652|NCT01125930|141685633|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.||||1.00
71089653|NCT01125930|141685633|SUPERIORITY_OR_OTHER|||||||0.96|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.||||0.96
71089654|NCT01125930|141685633|SUPERIORITY_OR_OTHER|||||||0.91|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.||||0.91
71089655|NCT01125930|141685634|SUPERIORITY_OR_OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.||||0.29
71126572|NCT00727558|141759436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.1648||||98.7|-0.2375|0.132|||Mixed Models Analysis||Mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A||0.132|-0.2375|
71126573|NCT00727558|141759437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2469|STANDARD_ERROR_OF_MEAN|0.04448||||97.47|-0.2469|-0.1599|||Mixed Models Analysis||The mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A by having a lower level of inferior region corneal staining||-0.1599|-0.2469|
71126574|NCT02100475|141759446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.427|TWO_SIDED|95.0|-1.05|0.46|||ANCOVA|||The response and change from baseline in the response after 26 weeks of treatment was analysed using an analysis of covariance (ANCOVA) method with treatment and baseline IDegLira dose strata as fixed factors and baseline response as a covariate. Missing data were imputed using LOCF.||0.46|-1.05|0.427
70857848|NCT03274999|141201707|SUPERIORITY|||||||0.053||||||T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.053
71089656|NCT01125930|141685634|SUPERIORITY_OR_OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.||||0.29
71089657|NCT01125930|141685634|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.||||0.15
71089658|NCT01125930|141685634|SUPERIORITY_OR_OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.||||0.29
71089659|NCT01125930|141685635|SUPERIORITY_OR_OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.||||0.54
71126575|NCT00757822|141759452|SUPERIORITY_OR_OTHER||Difference in Percentages|4.6|||>|0.76|TWO_SIDED|90.0|-9.5|18.6|||Fisher Exact|||The incidence of PON per arm will be determined and expressed as a percentage of the total patients per arm. Treatment efficacy will be measured as the percentage-point decrease in PON in the treatment arm (Marinol) compared to the standard therapy arm (ondansetron). Null hypothesis: Marinol treatment is not superior to ondansetron treatment. We will test the statistical significance with Fisher's Exact test at a significance level of 0.05||18.6|-9.5|>0.76
71126576|NCT00757822|141759453|SUPERIORITY_OR_OTHER||||||>|0.92|||||||Fisher Exact|One-sided Fisher's Exact test was performed comparing the percentage of subjects with at least one VAS score \> 0. (Marinol\>Ondansetron).||||||>0.92
71126577|NCT00757822|141759454|SUPERIORITY_OR_OTHER||Difference in Percentages|7.7|||>|0.55|TWO_SIDED|90.0|-12.1|13.3|||Fisher Exact|||||13.3|-12.1|>0.55
71126578|NCT00757822|141759455|SUPERIORITY_OR_OTHER||||||=|0.981|TWO_SIDED||||||Wilcoxon Rank-Sum test|||||||=0.981
71126579|NCT00757822|141759456|SUPERIORITY_OR_OTHER||||||>|0.9|||||||Fisher Exact|||||||>0.90
71126580|NCT00757822|141759457|SUPERIORITY_OR_OTHER||||||>|0.37|TWO_SIDED||||||Fisher Exact|||||||>0.37
71126581|NCT00757822|141759458|SUPERIORITY_OR_OTHER||||||>|0.75|TWO_SIDED||||||FREQ Procedure|||Comparisons at 24-48 hr post-surgery. Null hypothesis: dronabinol is not superior to ondansetron in patient satisfaction.||||>0.75
70857849|NCT03274999|141201707|SUPERIORITY|||||||0.206||||||T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.206
71126582|NCT00757822|141759458|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||FREQ procedure|||Comparisons of both arms at 2-6 weeks; null hypothesis: dronabinol is not superior to ondansetron in patient satisfaction||||>0.10
71126583|NCT00757822|141759459|SUPERIORITY_OR_OTHER||||||>|0.29|TWO_SIDED||||||FREQ procedure|||Comparison of both group responses at 24-48 hours.||||>0.29
71126584|NCT00757822|141759459|SUPERIORITY_OR_OTHER||||||>|0.55|TWO_SIDED||||||FREQ Procedure|||Comparisons of both arms at 2-6 weeks.||||>0.55
71126585|NCT02814175|141759460|OTHER|Between group difference|point estimate difference|28.3|||<|0.001|TWO_SIDED|95.0|17.8|38.9|||Cochran-Mantel-Haenszel|Adjusted for the stratification factor which is the duration of prior MTX 15 mg ew use of ≤ 3 months or \> 3 months.||||38.9|17.8|< 0.001
71126586|NCT03416127|141759473|OTHER|||||||0.031|||||||Kruskal-Wallis|||||||0.031
71126587|NCT03416127|141759474|OTHER|||||||0.963|||||||Kruskal-Wallis|||||||0.963
70857850|NCT03274999|141201707|SUPERIORITY|||||||0.221||||||T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.221
70857851|NCT03274999|141201707|SUPERIORITY|||||||0.126||||||T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.126
71126588|NCT03416127|141759475|OTHER|||||||0.236|||||||Kruskal-Wallis|||||||0.236
71126589|NCT03416127|141759476|OTHER|||||||0.015|||||||Kruskal-Wallis|||||||0.015
71126590|NCT03416127|141759477|OTHER|||||||0.017|||||||Kruskal-Wallis|||||||0.017
71126591|NCT03416127|141759478|OTHER|||||||0.162|||||||Kruskal-Wallis|||||||0.162
71126592|NCT03416127|141759479|OTHER|||||||0.686|||||||Kruskal-Wallis|||||||0.686
71126593|NCT03416127|141759480|OTHER|||||||0.004|||||||Kruskal-Wallis|||||||0.004
71126594|NCT03416127|141759481|OTHER|||||||0.945|||||||Kruskal-Wallis|||||||0.945
71126595|NCT03416127|141759482|OTHER|||||||0.332|||||||Kruskal-Wallis|||||||0.332
71126596|NCT03416127|141759483|OTHER|||||||0.075|||||||Kruskal-Wallis|||||||0.075
71126597|NCT03416127|141759484|OTHER|||||||0.903|||||||Kruskal-Wallis|||||||0.903
71126598|NCT03416127|141759485|OTHER|||||||0.697|||||||Kruskal-Wallis|||||||0.697
71126599|NCT03416127|141759486|OTHER|||||||0.668|||||||Kruskal-Wallis|||||||0.668
71126600|NCT03416127|141759487|OTHER|||||||0.308|||||||Kruskal-Wallis|||||||0.308
71126601|NCT03416127|141759488|OTHER|||||||0.318|||||||Kruskal-Wallis|||||||0.318
71126602|NCT03416127|141759489|OTHER|||||||0.88|||||||Kruskal-Wallis|||||||0.880
71126603|NCT03416127|141759490|OTHER|||||||0.376|||||||Kruskal-Wallis|||||||0.376
71126604|NCT03416127|141759491|OTHER|||||||0.21|||||||Kruskal-Wallis|||||||0.210
71126605|NCT03416127|141759492|OTHER|||||||0.88|||||||Kruskal-Wallis|||||||0.880
71126606|NCT03416127|141759493|OTHER|||||||0.059|||||||Kruskal-Wallis|||||||0.059
71126607|NCT03416127|141759494|OTHER|||||||0.978|||||||Kruskal-Wallis|||||||0.978
71126608|NCT03416127|141759495|OTHER|||||||0.122|||||||Kruskal-Wallis|||||||0.122
71126609|NCT03416127|141759496|OTHER|||||||0.551|||||||Kruskal-Wallis|||||||0.551
71126610|NCT02702180|141759497|SUPERIORITY||Least Square Means (LSmean)|-4.6||||0.1688|TWO_SIDED|95.0|-11.1|2.0|||ANCOVA||The estimated value represents the estimated difference between once daily molgramostim and placebo groups in LSmean change from baseline to week 24.|Primary endpoint was evaluated using analysis of covariance with treatment, whole lung lavage within 2 months before baseline, and geographic region as factors, and baseline values as covariates. To control type I error, key secondary endpoints were analyzed using a testing hierarchy wherein once daily molgramostim and placebo was compared and if statistical significance was reached, evaluation of intermittent molgramostim and placebo would proceed.||2.0|-11.1|0.1688
71126611|NCT02702180|141759497|SUPERIORITY||Least Square Means (LSmean)|-2.8||||0.3968|TWO_SIDED|95.0|-9.3|3.7|||ANCOVA||The estimated value represents the estimated difference between intermittent molgramostim and placebo groups in LSmean change from baseline to week 24.|||3.7|-9.3|0.3968
71126612|NCT02702180|141759498|SUPERIORITY||Least Square Means (LSmean)|20.6||||0.3159|TWO_SIDED|95.0|-19.8|61.0|||ANCOVA||The estimated value represents the estimated difference between once daily molgramostim and placebo groups in LSmean change from baseline to week 24.|||61.0|-19.8|0.3159
71126613|NCT02702180|141759498|SUPERIORITY||Least Square Means (LSmean)|5.6||||0.7809|TWO_SIDED|95.0|-34.1|45.2|||ANCOVA||The estimated value represents the estimated difference between intermittent molgramostim and placebo groups in LSmean change from baseline to week 24.|||45.2|-34.1|0.7809
71126614|NCT02702180|141759499|SUPERIORITY||Least Square Means (LSmean)|-7.6||||0.0103|TWO_SIDED|95.0|-13.4|-1.8|||ANCOVA||The estimated value represents the estimated difference between once daily molgramostim and placebo groups in LSmean change from baseline to week 24.|||-1.8|-13.4|0.0103
71126615|NCT02702180|141759499|SUPERIORITY||Least Square Means (LSmean)|-7.0||||0.0173|TWO_SIDED|95.0|-12.7|-1.3|||ANCOVA||The estimated value represents the estimated difference between intermittent molgramostim and placebo groups in LSmean change from baseline to week 24..|||-1.3|-12.7|0.0173
71126616|NCT02702180|141759500|SUPERIORITY||Risk Ratio (RR)|0.284||||0.1918|TWO_SIDED|95.0|0.043|1.881|||Negative binomial regression||The estimated value represents the RR between once daily molgramostim and placebo groups.|||1.881|0.043|0.1918
71126617|NCT02702180|141759500|SUPERIORITY||Risk Ratio (RR)|0.367||||0.2421|TWO_SIDED|95.0|0.068|1.968|||Negative binomial regression||The estimated value represents the RR between intermittent molgramostim and placebo groups.|||1.968|0.068|0.2421
71126618|NCT02397057|141759507|OTHER|Observed cases, logistic regression analysis. Subjects with missing data on Day 42 were excluded from the statistical testing.|Odds Ratio (OR)|1.35||||0.369|TWO_SIDED|95.0|0.7|2.63||p-value was estimated by logistic regression with treatment, region (US, EUR), and baseline RLS medication-related augmentation as fixed factors, and baseline IRLS as a covariate.|Regression, Logistic|||||2.63|0.70|0.3690
71126619|NCT02397057|141759511|OTHER||Least square(LS) mean difference|-4.071|STANDARD_ERROR_OF_MEAN|2.542||0.1108|TWO_SIDED|95.0|-9.083|0.941|||ANCOVA|||LOCF, ANCOVA Analysis||0.941|-9.083|0.1108
71126620|NCT02397057|141759512|OTHER|||||||0.0002||||||p-value was estimated using continuity-corrected chi-square test.|Chi-squared, Corrected|||||||0.0002
71126621|NCT04473664|141759513|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean]|95.1|||||TWO_SIDED|90.0|77.1|117.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|Statistical comparison was analyzed for Quizartinib.||117|77.1|
71126622|NCT04473664|141759515|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean]|109.0|||||TWO_SIDED|90.0|59.5|201.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|AUClast statistical comparison was analyzed for Quizartinib.||201|59.5|
71126623|NCT04473664|141759515|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean]|109.0|||||TWO_SIDED|90.0|57.9|207.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|AUCinf statistical comparison was analyzed for Quizartinib.||207|57.9|
70857852|NCT03274999|141201707|SUPERIORITY|||||||0.124||||||T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.124
70857853|NCT03274999|141201707|SUPERIORITY|||||||0.167||||||T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.167
71126624|NCT04473664|141759519|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|74.4|||||TWO_SIDED|90.0|32.0|173.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|Statistical comparison was analyzed for AC886.||173|32.0|
71126625|NCT04473664|141759521|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|62.5|||||TWO_SIDED|90.0|35.3|111.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|AUClast statistical comparison was analyzed for AC886.||111|35.3|
71126626|NCT04473664|141759521|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|69.9|||||TWO_SIDED|90.0|46.8|104.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|AUCinf statistical comparison was analyzed for AC886.||104|46.8|
71126627|NCT04473664|141759524|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|44.7|||||TWO_SIDED|90.0|18.0|111.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|Statistical comparison was analyzed for Quizartinib.||111|18.0|
71126628|NCT04473664|141759525|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|51.5|||||TWO_SIDED|90.0|16.0|165.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|AUClast statistical comparison was analyzed for Quizartinib.||165|16.0|
71126629|NCT04473664|141759525|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|51.5|||||TWO_SIDED|90.0|15.8|168.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|AUCinf statistical comparison was analyzed for Quizartinib.||168|15.8|
71126630|NCT03392649|141759529|SUPERIORITY|||||||0.6|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.60
70857854|NCT03274999|141201707|SUPERIORITY|||||||0.377||||||T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.377
71126631|NCT03392649|141759530|SUPERIORITY|||||||0.34|||||||Chi-squared|||||||0.34
71126632|NCT03392649|141759531|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
71126633|NCT03392649|141759532|SUPERIORITY|||||||0.09|||||||Fisher Exact|||||||0.09
71126634|NCT03392649|141759533|SUPERIORITY|||||||0.16|||||||Fisher Exact|||||||0.16
71126635|NCT03392649|141759534|SUPERIORITY|||||||0.67|||||||Fisher Exact|||||||0.67
71126636|NCT03392649|141759535|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
71126637|NCT03392649|141759536|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
71126638|NCT03927144|141759563|SUPERIORITY||Odds Ratio (OR)|6.48|||<|0.0001|TWO_SIDED|95.0|4.28|9.82|||Cochran-Mantel-Haenszel|Adjusted for stratification factor (no. of prior prophylactic migraine treatment failures=1 vs 2) after missing data were imputed as non-response.||||9.82|4.28|<0.0001
70857855|NCT03274999|141201707|SUPERIORITY|||||||0.397||||||T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.397
70857856|NCT03274999|141201707|SUPERIORITY|||||||0.441||||||T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.441
70946395|NCT00551135|141392988|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2639|TWO_SIDED||||||ANOVA|||MCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.2639
71126639|NCT03927144|141759564|SUPERIORITY||Odds Ratio (OR)|11.27|||<|0.0001|TWO_SIDED|95.0|7.53|16.87|||Cochran-Mantel-Haenszel|Adjusted for number of prior prophylactic migraine treatment failures=1 vs 2 after missing data were imputed as non-response.||||16.87|7.53|<0.0001
71126640|NCT03927144|141759565|SUPERIORITY||Treatment difference|-2.13|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.74|-1.52|||Linear mixed effects model||AMG334 70 mg/140 mg vs Oral Prophylactic|Comparison of mean change from baseline in monthly migraine days at Week 52||-1.52|-2.74|<0.001
71126641|NCT03927144|141759566|SUPERIORITY||Odds Ratio (OR)|13.75|||<|0.001|TWO_SIDED|95.0|9.08|20.83|||Cochran-Mantel-Haenszel|Adjusted for number of prior prophylactic migraine treatment failures=1 vs 2 after missing data were imputed as non-response.||||20.83|9.08|<0.001
71126642|NCT01452919|141759569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-1.73|STANDARD_ERROR_OF_MEAN|1.25||0.17||95.0||||Two-sided p-value.|Type 3 sums of squares|||||||0.170
71126643|NCT01452919|141759570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.8|STANDARD_ERROR_OF_MEAN|0.5||0.109||95.0||||Two-sided p-value. P-value is for Week 0.5.|Type 3 sums of squares|||||||0.109
71126644|NCT01452919|141759570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.4|STANDARD_ERROR_OF_MEAN|0.4||0.372||95.0||||Two-sided p-value. P-value is for Week 1.|Type 3 sums of squares|||||||0.372
71126645|NCT01452919|141759570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.2|STANDARD_ERROR_OF_MEAN|0.4||0.555||95.0||||Two-sided p-value. P-value is for Week 1.5.|Type 3 sums of squares|||||||0.555
71126646|NCT01452919|141759570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.1|STANDARD_ERROR_OF_MEAN|0.4||0.806||95.0||||Two-sided p-value. P-value is for Week 2.|Type 3 sums of squares|||||||0.806
70857857|NCT03274999|141201708|SUPERIORITY|||||||0.034||||||T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.034
70857858|NCT03274999|141201708|SUPERIORITY|||||||0.143||||||T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.143
70857859|NCT03274999|141201708|SUPERIORITY|||||||0.328||||||T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.328
70946396|NCT00551135|141392988|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2524|TWO_SIDED||||||ANOVA|||MCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.2524
71126647|NCT01452919|141759571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.762||95.0||||Two-sided p-value.|Type 3 sums of squares|||||||0.762
71126648|NCT01452919|141759572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.506||95.0||||Two-sided p-value.|Type 3 sums of squares|||||||0.506
71126649|NCT01452919|141759573|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.515||95.0||||Two-sided p-value.|Type 3 sums of squares|||||||0.515
71126650|NCT01452919|141759576|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.2|STANDARD_ERROR_OF_MEAN|0.1||0.966||95.0||||One-sided p-value.|Type 3 sums of squares|||||||0.966
71126651|NCT01452919|141759577|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.92|STANDARD_ERROR_OF_MEAN|0.73||0.895||95.0||||One-sided p-value.|Type 3 sums of squares|||||||0.895
71126652|NCT02421588|141759578|SUPERIORITY||Hazard Ratio (HR)|1.057||||0.6294|TWO_SIDED|95.0|0.854|1.309|||Log Rank|||PFS between treatments||1.309|0.854|0.6294
71126653|NCT02421588|141759578|SUPERIORITY||PFS at 6 months|24.3|||||TWO_SIDED|95.0|18.4|30.7|||||Percent of Participants|PFS (%) at 6 months||30.7|18.4|
71126654|NCT02421588|141759578|SUPERIORITY||PFS at 6 months|27.5|||||TWO_SIDED|95.0|20.9|34.4|||||Percent of Participants|PFS (%) at 6 months||34.4|20.9|
71126655|NCT02421588|141759578|SUPERIORITY|||||||0.5032|||||||Normal approximation|||PFS (%) at 6 months between treatments||||0.5032
71126656|NCT02421588|141759578|SUPERIORITY||PFS at 12 months|8.3|||||TWO_SIDED|95.0|4.7|13.3|||||Percent of Participants|PFS (%) at 12 months||13.3|4.7|
71126657|NCT02421588|141759578|SUPERIORITY||PFS at 12 months|7.0|||||TWO_SIDED|95.0|3.3|12.5|||||Percent of Participants|PFS (%) at 12 months||12.5|3.3|
71126658|NCT02421588|141759578|SUPERIORITY|||||||0.6742|||||||Normal approximation|||PFS (%) at 12 months between treatments||||0.6742
71126659|NCT02421588|141759579|SUPERIORITY||Hazard Ratio (HR)|0.987||||0.7673|TWO_SIDED|95.0|0.805|1.209|||Log Rank|||PFS between treatments||1.209|0.805|0.7673
71126660|NCT02421588|141759579|SUPERIORITY||PFS at 6 months|29.0|||||TWO_SIDED|95.0|22.8|35.4|||||Percent of Participants|PFS (%) at 6 months||35.4|22.8|
71126661|NCT02421588|141759579|SUPERIORITY||PFS at 6 months|27.4|||||TWO_SIDED|95.0|21.3|33.9|||||Percent of Participants|PFS (%) at 6 months||33.9|21.3|
71126662|NCT02421588|141759579|SUPERIORITY|||||||0.7385|||||||Normal approximation|||PFS (%) at 6 months between treatments||||0.7385
71126663|NCT02421588|141759579|SUPERIORITY||PFS (%) at 12 months|8.2|||||TWO_SIDED|95.0|4.8|12.7|||||Percent of Participants|PFS (%) at 12 months||12.7|4.8|
71126664|NCT02421588|141759579|SUPERIORITY||PFS (%) at 12 months|7.5|||||TWO_SIDED|95.0|4.2|12.2|||||Percent of Participants|PFS (%) at 12 months||12.2|4.2|
71126665|NCT02421588|141759579|SUPERIORITY|||||||0.8245|||||||Normal approximation|||PFS (%) at 12 months between treatments||||0.8245
71126666|NCT02421588|141759580|SUPERIORITY||Hazard Ratio (HR)|0.956||||0.8021|TWO_SIDED|95.0|0.772|1.183|||Log Rank|||OS between treatments||1.183|0.772|0.8021
71126667|NCT02421588|141759580|SUPERIORITY||OS at 12 months|48.2|||||TWO_SIDED|95.0|41.3|54.8|||||Percent of Participants|OS (%) at 12 months||54.8|41.3|
71126668|NCT02421588|141759580|SUPERIORITY||OS (%) at 12 months|45.3|||||TWO_SIDED|95.0|38.4|52.0|||||Percent of Participants|OS (%) at 12 months||52.0|38.4|
71126669|NCT02421588|141759580|SUPERIORITY|||||||0.5515|||||||Normal approximation|||OS (%) at 12 months between treatments||||0.5515
71126670|NCT02421588|141759580|SUPERIORITY||OS (%) at 24 months|22.3|||||TWO_SIDED|95.0|16.8|28.2|||||Percent of Participants|OS (%) at 24 months||28.2|16.8|
71126671|NCT02421588|141759580|SUPERIORITY||OS (%) at 24 months|22.7|||||TWO_SIDED|95.0|17.1|28.7|||||Percent of Participants|OS (%) at 24 months||28.7|17.1|
71126672|NCT02421588|141759580|SUPERIORITY|||||||0.9253|||||||Normal approximation|||OS (%) at 24 months between treatments||||0.9253
71126673|NCT02421588|141759581|SUPERIORITY||ORR|14.5|||||TWO_SIDED|95.0|10.1|19.8|||||Percent of Participants|Overall response rate||19.8|10.1|
71126674|NCT02421588|141759581|SUPERIORITY||ORR|12.7|||||TWO_SIDED|95.0|8.6|17.8|||||Percent of Participants|Overall response rate||17.8|8.6|
71126675|NCT02421588|141759581|SUPERIORITY|||||||0.6772|||||||Fisher Exact|||Overall response rate between treatments||||0.6772
71126676|NCT02421588|141759582|SUPERIORITY||ORR|15.8|||||TWO_SIDED|95.0|11.3|21.3|||||Percent of Participants|Overall response rate (ORR)||21.3|11.3|
71126677|NCT02421588|141759582|SUPERIORITY||Overall response rate (ORR)|16.7|||||TWO_SIDED|95.0|12.1|22.3|||||Percent of Participants|Overall response rate (ORR)||22.3|12.1|
71126678|NCT02421588|141759582|SUPERIORITY|||||||0.8976|||||||Fisher Exact|||Overall response rate (ORR) between treatments||||0.8976
71126679|NCT02421588|141759583|SUPERIORITY||Hazard Ratio (HR)|1.406||||0.2631|TWO_SIDED|95.0|0.769|2.569|||Log Rank|||Duration of response between treatments||2.569|0.769|0.2631
71126680|NCT02421588|141759584|SUPERIORITY|Duration of response between treatments|Hazard Ratio (HR)|1.056||||0.8276|TWO_SIDED|95.0|0.64|1.743|||Log Rank|||||1.743|0.64|0.8276
71126681|NCT02421588|141759585|SUPERIORITY||ORR (%)|26.6|||||TWO_SIDED|95.0|20.2|33.8|||||Percent of Participants|ORR (%) by CA-125||33.8|20.2|
71126682|NCT02421588|141759585|SUPERIORITY||ORR (%)|19.4|||||TWO_SIDED|95.0|13.7|26.3|||||Percent of Participants|ORR (%) by CA-125||26.3|13.7|
71126683|NCT02421588|141759585|SUPERIORITY|||||||0.1231|||||||Fisher Exact|||ORR (%) by CA-125 between treatments||||0.1231
71126685|NCT03270891|141759627|SUPERIORITY|Null hypothesis of equality.||||||0.0115|||||||t-test, 2 sided|||Baseline and 6 month values||||0.0115
71126686|NCT03270891|141759627|SUPERIORITY|Null hypothesis of equality.||||||0.027|||||||t-test, 2 sided|||baseline to 6 month comparison||||0.027
71126687|NCT03270891|141759628|SUPERIORITY|Null hypothesis of equality.||||||0.0327|||||||t-test, 2 sided|||Baseline p value to six month||||0.0327
71126688|NCT03270891|141759628|SUPERIORITY|Null hypothesis of equality.||||||0.2088|||||||t-test, 2 sided|||baseline to 6 month comparison p value||||0.2088
71126689|NCT03270891|141759629|SUPERIORITY|Null hypothesis of equality.||||||0.947|||||||t-test, 2 sided|||baseline to 6 month comparison||||0.947
71126690|NCT02516592|141759639|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.028|TWO_SIDED|95.0|0.005|0.084|||Mixed Models Analysis|||||0.084|0.005|0.028
71126691|NCT02516592|141759640|SUPERIORITY||Mean Difference (Final Values)|0.46||||0.063|TWO_SIDED|95.0|-0.03|0.94|||Mixed Models Analysis|||||0.94|-0.03|0.063
71126692|NCT02516592|141759641|SUPERIORITY||Mean Difference (Final Values)|0.102||||0.002|TWO_SIDED|95.0|0.037|0.167|||Mixed Models Analysis|||||0.167|0.037|0.002
71126693|NCT02516592|141759642|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.319|TWO_SIDED|95.0|-1.3|0.4|||Mixed Models Analysis|||||0.4|-1.3|0.319
71126694|NCT02516592|141759643|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.662|TWO_SIDED|95.0|-0.2|0.13|||Mixed Models Analysis|||||0.13|-0.20|0.662
71126695|NCT00510744|141759657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|24.0|<|0.05|TWO_SIDED||||||t-test, 2 sided|||paired changes in fat absorption assessed by parametric (t test) or non-parametric tests (Mann-Whitney)||||<0.05
71126696|NCT02522442|141759665|OTHER|Pilot study, not powered for any endpoint.||||||0.377|||||||Chi-squared|||Pilot study, not powered for any endpoint.||||0.377
71126697|NCT02522442|141759666|OTHER|Pilot study, not powered for any endpoint.||||||0.624|||||||Chi-squared|||||||.624
71126698|NCT00462748|141759718|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Hochberg's FDR was used to power the study; the power was based on a two-sided p value of 0.025.|Regression, Logistic|The logistic regression model included terms for treatment and stratum; treatment by stratum interaction was assessed.||Ho is no difference in proportion achieving the target of LDL-C \< 2mmol/l.. 240 patients per group give a power of at least 85% to detect a 15% difference in this proportion, assuming the percentage decrease from baseline in LDL-C was 25% in the E/S group and 15% in the two comparator groups. A two-sided 0.025 test to allow for multiple comparisons was used.||||<0.001
71126699|NCT00462748|141759718|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Hochberg's FDR was used to power the study; the power was based on a two-sided p value of 0.025.|Regression, Logistic|The logistic regression model included terms for treatment and stratum; treatment by stratum interaction was assessed.||Ho is no difference in proportion achieving the target of LDL-C \< 2mmol/l.. 240 patients per group give a power of at least 85% to detect a 15% difference in this proportion, assuming the percentage decrease from baseline in LDL-C was 25% in the E/S group and 15% in the two comparator groups. A two-sided 0.025 test to allow for multiple comparisons was used.||||<0.001
71126700|NCT03233438|141759719|SUPERIORITY||Mean Difference (Final Values)|1.6|STANDARD_DEVIATION|2.5||0.003|TWO_SIDED|95.0|0.6|2.6|||t-test, 2 sided|||||2.6|0.6|0.003
71126701|NCT03233438|141759720|SUPERIORITY||Mean Difference (Final Values)|1.7|STANDARD_DEVIATION|2.56||0.003|TWO_SIDED|95.0|0.6|2.8|||t-test, 2 sided|||||2.8|0.6|0.003
71126702|NCT03429543|141759750|OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.33||0.2935|TWO_SIDED|95.0|-0.99|0.3|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Treatment group 1 (TG1) consisting of Placebo, Linagliptin 5 mg and Empagliflozin pooled Patients: Analysis of covariance (ANCOVA) model with a continuous covariate (baseline HbA1c) and categorical covariates (treatment and age). The effect of linagliptin and of empagliflozin (including responders and non-responders) was compared with placebo at an overall α of 0.05 (2-sided) using the Hochberg method to account for multiple testing.||0.30|-0.99|0.2935
71126703|NCT03429543|141759750|OTHER||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.33||0.0116|TWO_SIDED|95.0|-1.5|-0.19|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Treatment group 1 (TG1) consisting of Placebo, Linagliptin 5 mg and Empagliflozin pooled Patients: Analysis of covariance (ANCOVA) model with a continuous covariate (baseline HbA1c) and categorical covariates (treatment and age). The effect of linagliptin and of empagliflozin (including responders and non-responders) was compared with placebo at an overall α of 0.05 (2-sided) using the Hochberg method to account for multiple testing.||-0.19|-1.50|0.0116
71126704|NCT03429543|141759750|OTHER|Only after having obtained statistically significant results for both hypotheses of the primary family of hypotheses (TG1), the secondary hypotheses were to compare the individual empagliflozin doses versus placebo based on TG2 and TG3.The ANCOVA utilised a weight of zero for patients who were not in the hypothesis test of interest, a value of 2 for re-randomised patients who were in the hypothesis test of interest and a value of 1 otherwise.|Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.4||0.1943|TWO_SIDED|95.0|-1.31|0.27|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Treatment group 2 (TG2) consisting of Placebo, Empagliflozin 25mg Patients: Analysis of covariance (ANCOVA) model with a continuous covariate (baseline HbA1c) and categorical covariates (treatment and age). The effect of linagliptin and of empagliflozin (including responders and non-responders) was compared with placebo at an overall α of 0.05 (2-sided) using the Hochberg method to account for multiple testing.||0.27|-1.31|0.1943
71126705|NCT03429543|141759750|OTHER|Only after having obtained statistically significant results for both hypotheses of the primary family of hypotheses (TG1), the secondary hypotheses were to compare the individual empagliflozin doses versus placebo based on TG2 and TG3.The ANCOVA utilised a weight of zero for patients who were not in the hypothesis test of interest, a value of 2 for re-randomised patients who were in the hypothesis test of interest and a value of 1 otherwise.|Mean Difference (Final Values)|-1.18|STANDARD_ERROR_OF_MEAN|0.37||0.0015|TWO_SIDED|95.0|-1.9|-0.45|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Treatment group 3 (TG3) consisting of Placebo, Empagliflozin 10mg Patients: Analysis of covariance (ANCOVA) model with a continuous covariate (baseline HbA1c) and categorical covariates (treatment and age). The effect of linagliptin and of empagliflozin (including responders and non-responders) was compared with placebo at an overall α of 0.05 (2-sided) using the Hochberg method to account for multiple testing.||-0.45|-1.90|0.0015
71126706|NCT03429543|141759751|OTHER||Risk Difference (RD)|-10.0||||1|TWO_SIDED|90.0|-58.7|43.7|||Fisher Exact||Risk difference calculated as \[treatment\]-\[placebo\].|Risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 90% confidence interval based on the method of Chan and Zhang. Patients were assigned to the treatment they were randomised to at the initial randomisation.||43.7|-58.7|1.0000
71126707|NCT03429543|141759751|OTHER||Risk Difference (RD)|-10.0||||1|TWO_SIDED|90.0|-58.7|43.7|||Fisher Exact||Risk difference calculated as \[treatment\]-\[placebo\].|Risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 90% confidence interval based on the method of Chan and Zhang. Patients were assigned to the treatment they were randomised to at the initial randomisation.||43.7|-58.7|1.0000
70946397|NCT00551135|141392988|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0832|TWO_SIDED||||||ANOVA|||MCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.0832
70946398|NCT00551135|141392989|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2371|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||1 month PS.||||0.2371
70946399|NCT00551135|141392989|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4435|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||1 month PS.||||0.4435
70946400|NCT00551135|141392989|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1692|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||1 month PS.||||0.1692
70946401|NCT00551135|141392989|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8169|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||3 month PS.||||0.8169
71089660|NCT01125930|141685635|SUPERIORITY_OR_OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.||||0.06
71089661|NCT01125930|141685635|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.||||0.02
71089662|NCT01125930|141685635|SUPERIORITY_OR_OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.||||0.09
71126708|NCT03429543|141759752|OTHER||Adjusted mean difference|-0.68||||0.4828|TWO_SIDED|95.0|-2.86|1.49|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Restricted maximum likelihood (REML) approach with mixed model for repeated measures (MMRM). Fixed categorical effects of treatment, visit, and treatment-by-visit interaction and categorical covariate age (baseline) and continuous, fixed covariates of baseline of response variable and baseline of response variable-by-visit interaction. Covariate visit was treated as repeated measure with an unstructured covariance structure used to model within-patient measurements.||1.49|-2.86|0.4828
71126709|NCT03429543|141759752|OTHER||Adjusted mean difference|-0.38||||0.7047|TWO_SIDED|95.0|-2.64|1.88|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Restricted maximum likelihood (REML) approach with mixed model for repeated measures (MMRM). Fixed categorical effects of treatment, visit, and treatment-by-visit interaction and categorical covariate age (baseline) and continuous, fixed covariates of baseline of response variable and baseline of response variable-by-visit interaction. Covariate visit was treated as repeated measure with an unstructured covariance structure used to model within-patient measurements.||1.88|-2.64|0.7047
71126710|NCT03429543|141759753|OTHER|||||||0.8626|||||||Log Rank|||Time to treatment failure was analysed by Kaplan-Meier estimates up to the end of the study. A log-rank test compared linagliptin and empagliflozin pooled versus placebo up to Week 26.||||0.8626
70946402|NCT00551135|141392989|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5592|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||3 month PS.||||0.5592
70946403|NCT00551135|141392989|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4453|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||3 month PS.||||0.4453
70857860|NCT03274999|141201708|SUPERIORITY|||||||0.25||||||T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.250
70946404|NCT00551135|141392989|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4795|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||6 month PS.||||0.4795
70946405|NCT00551135|141392989|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2733|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||6 month PS.||||0.2733
70946406|NCT00551135|141392989|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||6 month PS.||||0.3173
70946407|NCT01983553|141393000|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.93|||||TWO_SIDED|95.0|0.64|1.36|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Any of the 4 Serotypes||1.36|0.64|
71089663|NCT01125930|141685636|SUPERIORITY_OR_OTHER|||||||0.18|||||||Fisher Exact|||Group comparison at Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have different values than the other.||||0.18
71126711|NCT03429543|141759753|OTHER|||||||0.2827|||||||Log Rank|||Time to treatment failure was analysed by Kaplan-Meier estimates up to the end of the study. A log-rank test compared linagliptin and empagliflozin pooled versus placebo up to Week 26.||||0.2827
71089664|NCT01125930|141685636|SUPERIORITY_OR_OTHER|||||||0.7|||||||Fisher Exact|||Group comparison at Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have different values than the other.||||0.70
71089665|NCT01125930|141685636|SUPERIORITY_OR_OTHER|||||||0.7|||||||Fisher Exact|||Group comparison at Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have different values than the other.||||0.70
71089666|NCT01125930|141685636|SUPERIORITY_OR_OTHER|||||||0.35|||||||Fisher Exact|||Group comparison at Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have different values than the other.||||0.35
71089667|NCT01125930|141685637|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.||||0.80
71089668|NCT01125930|141685637|SUPERIORITY_OR_OTHER|||||||0.31|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.||||0.31
71089669|NCT01125930|141685637|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.||||0.25
70857861|NCT03274999|141201708|SUPERIORITY|||||||0.09||||||T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.090
70857862|NCT03274999|141201708|SUPERIORITY|||||||0.328||||||T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.328
71089670|NCT01125930|141685637|SUPERIORITY_OR_OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.||||0.46
71089671|NCT01125930|141685638|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.||||0.41
71089672|NCT01125930|141685638|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.||||0.05
71089673|NCT01125930|141685638|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.||||0.16
71089674|NCT01125930|141685638|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.||||0.14
70946408|NCT01983553|141393000|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 1 between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.96|||||TWO_SIDED|95.0|0.44|2.21|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Serotype 1||2.21|0.44|
71089675|NCT01125930|141685639|SUPERIORITY_OR_OTHER|||||||0.36|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.||||0.36
71089676|NCT01125930|141685639|SUPERIORITY_OR_OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.||||0.88
71089677|NCT01125930|141685639|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.||||0.18
71089678|NCT01125930|141685639|SUPERIORITY_OR_OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.||||0.17
71089679|NCT01125930|141685640|SUPERIORITY_OR_OTHER|||||||0.21|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application.||||0.21
71089680|NCT01125930|141685640|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application.||||<0.01
71089681|NCT01125930|141685640|SUPERIORITY_OR_OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application.||||0.04
71089682|NCT01125930|141685640|SUPERIORITY_OR_OTHER|||||||0.1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application.||||0.10
71089683|NCT01125930|141685641|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application.||||1.00
71089684|NCT01125930|141685641|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application.||||0.02
71089685|NCT01125930|141685641|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application.||||0.08
71089686|NCT01125930|141685641|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application.||||0.15
71089687|NCT01125930|141685642|SUPERIORITY_OR_OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application.||||0.67
70857863|NCT03274999|141201708|SUPERIORITY|||||||0.055||||||T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.055
71089688|NCT01125930|141685642|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application.||||0.18
71089689|NCT01125930|141685642|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 21 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application.||||0.02
71089690|NCT01125930|141685642|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application.||||0.42
71089691|NCT03098979|141685691|SUPERIORITY|||||||0.5183||||||Linear dose-response shape: The multiple comparison procedures (MCP) approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques.||||||0.5183
71089692|NCT03098979|141685691|SUPERIORITY|||||||0.33||||||Sigmoidal Emax 1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques||||||0.3300
71089693|NCT03098979|141685691|SUPERIORITY|||||||0.6232||||||Sigmoidal Emax 2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques||||||0.6232
71089694|NCT03098979|141685691|SUPERIORITY|||||||0.0918||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques||||||0.0918
71089695|NCT03098979|141685691|SUPERIORITY|||||||0.2701||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques||||||0.2701
71089696|NCT02369653|141685726|SUPERIORITY|||||||0.0403|||||||Cochran-Mantel-Haenszel|||||||0.0403
71089697|NCT02369653|141685727|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||||||1.0000
71089698|NCT02419807|141685747|EQUIVALENCE|Equivalence is defined as the difference in the proportions of nodes flagged between the Tc and ICG methods falling within an interval (-δ, +δ), where δ is taken to be 5%.|Mean Difference (Final Values)|0.09|||||TWO_SIDED|95.0|0.036|0.151||||||||0.151|0.036|
71089699|NCT04459338|141685799|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||All continuous data are summarized as means ± SEM. Area Under the Curve (AUC) was calculated using the trapezoidal rule. A paired, two-way Student t-test (parametric) or a Wilcoxon matched-pairs signed rank test (non-parametric) was used to examine differences between study days. A p-value \<0.05 was considered statistically significant.||||0.02
71089700|NCT02932943|141685807|SUPERIORITY||Least Squares Mean Difference|0.3||||0.6482|TWO_SIDED|95.0|-1.07|1.72|||Mixed Model Repeated Measures (MMRM)|||||1.72|-1.07|0.6482
71089701|NCT02932943|141685808|SUPERIORITY||Least Squares Mean Difference|-0.4||||0.559|TWO_SIDED|95.0|-1.61|0.87|||Mixed Model Repeated Measures (MMRM)|||||0.87|-1.61|0.5590
71089702|NCT02932943|141685809|SUPERIORITY||Least Squares Mean Difference|0.2||||0.8131|TWO_SIDED|95.0|-1.53|1.95|||Mixed Model Repeated Measures (MMRM)|||||1.95|-1.53|0.8131
71089703|NCT02932943|141685810|SUPERIORITY||Least Squares Mean Difference|-0.4||||0.6108|TWO_SIDED|95.0|-2.05|1.21|||Mixed Model Repeated Measures (MMRM)|||||1.21|-2.05|0.6108
71089704|NCT01259245|141685879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.017||||0.252|TWO_SIDED|95.0|-0.046|0.012||Regression coefficients from ANCOVA for Tai Chi intervention (PRP as reference) at 6 months after adjusted for baseline value of the outcome variable, age, sex, BMI, smoking and education|ANCOVA|||||0.012|-0.046|0.252
71089705|NCT01259245|141685880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005|STANDARD_DEVIATION|0.442||0.984|TWO_SIDED|95.0|-0.438|0.447|||ANCOVA|Adjusted for baseline values, age, sex, education, BMI and smoking||power0.80 for a medium effect size at 5% level of significance||0.447|-0.438|0.984
71089706|NCT01259245|141685881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.372|STANDARD_DEVIATION|4.433||0.869|TWO_SIDED|95.0|-4.061|4.805|||ANCOVA|adjusted for baseline values, age, sex, education, BMI and education||power of 0.80 for a medium effect size at 5% level of significance||4.805|-4.061|0.869
71089707|NCT01259245|141685882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.295|STANDARD_DEVIATION|4.706||0.588|TWO_SIDED|95.0|-6.001|3.411|||ANCOVA|adjusted for baseline values, age, sex, BMI, education and smoking||power of 0.80 for medium size effect at 5% level of significance||3.411|-6.001|0.588
71089708|NCT01259245|141685883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15|STANDARD_DEVIATION|4.477||0.345|TWO_SIDED|95.0|-6.627|2.327|||ANCOVA|adjusted for baseline values, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance||2.327|-6.627|0.345
71089709|NCT01259245|141685884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69|STANDARD_DEVIATION|4.062||0.413|TWO_SIDED|95.0|-5.753|2.372|||ANCOVA|adjusted for baseline value, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance||2.372|-5.753|0.413
70857864|NCT03274999|141201708|SUPERIORITY|||||||0.09||||||T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.090
70857865|NCT03274999|141201708|SUPERIORITY|||||||0.233||||||T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.233
70857866|NCT03274999|141201709|SUPERIORITY|||||||0.072||||||T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.072
70857867|NCT03274999|141201709|SUPERIORITY|||||||0.297||||||T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.297
70857868|NCT03274999|141201709|SUPERIORITY|||||||0.328||||||T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.328
71089710|NCT01259245|141685885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.049|STANDARD_DEVIATION|8.89||0.004|TWO_SIDED|95.0|4.159|21.939|||ANCOVA|adjusted for baseline value, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance||21.939|4.159|0.004
70857869|NCT03274999|141201709|SUPERIORITY|||||||0.447||||||T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.447
70857870|NCT03274999|141201709|SUPERIORITY|||||||0.328||||||T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.328
70857871|NCT03274999|141201709|SUPERIORITY|||||||0.09||||||T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.090
70857872|NCT03274999|141201709|SUPERIORITY|||||||0.055||||||T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.055
70857873|NCT03274999|141201709|SUPERIORITY|||||||0.09||||||T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.090
71089711|NCT01259245|141685886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_DEVIATION|0.226||0.56|TWO_SIDED|95.0|-0.1|0.184|||ANCOVA|adjusted for baseline value, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance||0.184|-0.100|0.560
70857874|NCT03274999|141201709|SUPERIORITY|||||||0.5||||||T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.500
70857875|NCT01545843|141201717|SUPERIORITY_OR_OTHER_LEGACY|||||||0.202|TWO_SIDED||||||Mixed Models Analysis|||||||.202
70857876|NCT04243421|141201725|OTHER||Median Difference (Final Values)|6.0||||0.0007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0007
70857877|NCT04243421|141201726|OTHER||Median Difference (Final Values)|1.25||||0.0005|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0005
70857878|NCT04243421|141201726|OTHER||Median Difference (Final Values)|1.0||||0.0034|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0034
70857879|NCT04243421|141201727|OTHER|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
70857880|NCT01249118|141201733|SUPERIORITY_OR_OTHER||Ratio of LS Means|8.45|||||TWO_SIDED|90.0|7.08|10.08|||||The 90 percent (%) confidence intervals (CI) of test group (oral dose) means relative to reference group (IV dose) means were obtained by taking antilog of corresponding 90% CI for the differences between the means on the log scale.|Least squares (LS) mean was calculated from analysis of variance (ANOVA). Data for dose-normalized Cmax were natural log-transformed prior to analysis.||10.08|7.08|
70946409|NCT01983553|141393000|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 between the CYD Dengue vaccine group and the Control group.|Relative Risk|1.326|||||TWO_SIDED|95.0|0.64|2.94|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Serotype 2||2.94|0.64|
71126712|NCT03429543|141759754|OTHER||Mean Difference (Final Values)|-5.41||||0.6438|TWO_SIDED|95.0|-28.49|17.67|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Analysis of covariance (ANCOVA) model with treatment as a fixed classification effect, baseline FPG as linear covariate and age at randomisation as categorical covariate. The random error was assumed to be normally distributed.||17.67|-28.49|0.6438
71126713|NCT03429543|141759754|OTHER||Mean Difference (Final Values)|-35.18||||0.0035|TWO_SIDED|95.0|-58.61|-11.74|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Analysis of covariance (ANCOVA) model with treatment as a fixed classification effect, baseline FPG as linear covariate and age at randomisation as categorical covariate. The random error was assumed to be normally distributed.||-11.74|-58.61|0.0035
71126714|NCT03429543|141759754|OTHER||Mean Difference (Final Values)|38.62||||0.031|TWO_SIDED|95.0|4.54|72.7|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Analysis of covariance (ANCOVA) model with treatment as a fixed classification effect, baseline FPG as linear covariate and age at randomisation as categorical covariate. The random error was assumed to be normally distributed.||72.70|4.54|0.0310
71126715|NCT03429543|141759754|OTHER||Mean Difference (Final Values)|20.05||||0.1994|TWO_SIDED|95.0|-13.01|53.11|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Analysis of covariance (ANCOVA) model with treatment as a fixed classification effect, baseline FPG as linear covariate and age at randomisation as categorical covariate. The random error was assumed to be normally distributed.||53.11|-13.01|0.1994
71126716|NCT03429543|141759755|OTHER||Mean Difference (Final Values)|1.46||||0.1394|TWO_SIDED|95.0|-0.48|3.41|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||3.41|-0.48|0.1394
71126717|NCT03429543|141759755|OTHER||Mean Difference (Final Values)|-0.75||||0.4476|TWO_SIDED|95.0|-2.68|1.19|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||1.19|-2.68|0.4476
71126718|NCT03429543|141759755|OTHER||Mean Difference (Final Values)|0.05||||0.9789|TWO_SIDED|95.0|-3.8|3.9|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||3.90|-3.80|0.9789
71126719|NCT03429543|141759755|OTHER||Mean Difference (Final Values)|-1.35||||0.5092|TWO_SIDED|95.0|-5.68|2.99|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||2.99|-5.68|0.5092
71126720|NCT03429543|141759756|OTHER||Mean Difference (Final Values)|0.91||||0.587|TWO_SIDED|95.0|-2.4|4.22|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||4.22|-2.40|0.5870
71126721|NCT03429543|141759756|OTHER||Mean Difference (Final Values)|-1.42||||0.3967|TWO_SIDED|95.0|-4.72|1.88|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||1.88|-4.72|0.3967
71126722|NCT03429543|141759756|OTHER||Mean Difference (Final Values)|2.53||||0.5414|TWO_SIDED|95.0|-6.42|11.47|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||11.47|-6.42|0.5414
71126723|NCT03429543|141759756|OTHER||Mean Difference (Final Values)|0.0||||0.9995|TWO_SIDED|95.0|-10.13|10.13|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||10.13|-10.13|0.9995
71126724|NCT03429543|141759757|OTHER||Mean Difference (Final Values)|1.5||||0.2433|TWO_SIDED|95.0|-1.03|4.02|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||4.02|-1.03|0.2433
71126725|NCT03429543|141759757|OTHER||Mean Difference (Final Values)|0.02||||0.9878|TWO_SIDED|95.0|-2.52|2.56|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||2.56|-2.52|0.9878
71126726|NCT03429543|141759757|OTHER||Mean Difference (Final Values)|3.33||||0.567|TWO_SIDED|95.0|-9.0|15.65|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||15.65|-9.00|0.5670
70946410|NCT01983553|141393000|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 3 between the CYD Dengue vaccine group and the Control group.|Relative Risk|1.056|||||TWO_SIDED|95.0|0.48|2.51|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Serotype 3||2.51|0.48|
70946411|NCT01983553|141393000|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.629|||||TWO_SIDED|95.0|0.27|1.47|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Serotype 4||1.47|0.27|
71089712|NCT01259245|141685887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|STANDARD_DEVIATION|0.088||0.425|TWO_SIDED|95.0|-0.054|0.128|||ANCOVA|adjusted for baseline value, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance||0.128|-0.054|0.425
71089713|NCT01259245|141685888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|STANDARD_DEVIATION|5.2||0.528|TWO_SIDED|95.0|-3.5|6.8|||ANCOVA|adjusted for baseline value, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance||6.8|-3.5|0.528
70857881|NCT01249118|141201737|SUPERIORITY_OR_OTHER||Ratio of LS Means|48.6|||||TWO_SIDED|90.0|41.43|56.94|||||The 90% CI of the test group (oral dose) means relative to the reference group (IV dose) means were obtained by taking the antilog of the corresponding 90% CI for the differences between the means on the log scale.|LS means was calculated from ANOVA. Data for dose-normalized AUC (0 - t) were natural log-transformed prior to analysis.||56.94|41.43|
70857882|NCT01249118|141201739|SUPERIORITY_OR_OTHER||Ratio of LS Means|45.9|||||TWO_SIDED|90.0|39.74|53.06|||||The 90% CI of the test group (oral dose) means relative to the reference group (IV dose) means were obtained by taking the antilog of the corresponding 90% CI for the differences between the means on the log scale.|LS mean was calculated from ANOVA. Data for dose-normalized AUC (0 - ∞) were natural log-transformed prior to analysis.||53.06|39.74|
70946412|NCT01983553|141393000|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Unserotyped between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.0|||||TWO_SIDED|95.0|0.0|1.22|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Unserotyped||1.22|0.00|
71089714|NCT00447083|141685892|OTHER|||||||0.1811|||||||t-test, 2 sided|||||||.1811
71089715|NCT01462942|141685899|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.125|||<|0.0001|TWO_SIDED|95.0|0.09|0.16|||Mixed Models Analysis|Adjusted by pre- and post-bronchodilator, age, and baseline FEV1 as covariates, and treatment group, sex, and smoking-status as fixed effect factors||||0.160|0.090|<0.0001
71089716|NCT01462942|141685899|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.069||||0.0001|TWO_SIDED|95.0|0.034|0.105|||Mixed Models Analysis|Adjusted by pre- and post-bronchodilator, age, and baseline FEV1 as covariates, and treatment group, sex, and smoking-status as fixed effect factors||||0.105|0.034|0.0001
71126727|NCT03429543|141759757|OTHER||Mean Difference (Final Values)|-6.62||||0.2348|TWO_SIDED|95.0|-18.19|4.95|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||4.95|-18.19|0.2348
71126728|NCT03429543|141759758|OTHER||Rate difference (percentage)|6.0||||0.3536|TWO_SIDED|95.0|-7.7|19.9|||Wald test||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and two-sided Wald test.||19.9|-7.7|0.3536
70946413|NCT01983553|141393003|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|1.411|||||TWO_SIDED|95.0|0.64|3.42|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Any Serotype||3.42|0.64|
71089717|NCT01462942|141685900|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.085|||<|0.0001|TWO_SIDED|95.0|0.051|0.119|||Mixed Models Analysis|Adjusted by pre- and post-bronchodilator, age, and baseline FEV1 as covariates, and treatment group, sex, and smoking-status as fixed effect factors||||0.119|0.051|<0.0001
71089718|NCT01462942|141685900|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.053||||0.0022|TWO_SIDED|95.0|0.019|0.087|||Mixed Models Analysis|Adjusted by pre- and post-bronchodilator, age, and baseline FEV1 as covariates, and treatment group, sex, and smoking-status as fixed effect factors||||0.087|0.019|0.0022
71089719|NCT01462942|141685901|SUPERIORITY_OR_OTHER||Least squares mean difference|1.293|||<|0.0001|TWO_SIDED|95.0|0.728|1.859|||Mixed Models Analysis|Adjusted by BDI baseline score and age as covariates, with treatment group, gender, smoking-status, visit, and group-by-visit as fixed effect factors||||1.859|0.728|<0.0001
71126729|NCT03429543|141759758|OTHER||Rate difference (percentage)|11.7||||0.0914|TWO_SIDED|95.0|-2.4|26.3|||Wald test||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and two-sided Wald test.||26.3|-2.4|0.0914
71126730|NCT03429543|141759758|OTHER||Rate difference (percentage)|-23.3||||0.5455|TWO_SIDED|90.0|-67.9|27.1|||Fisher Exact||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and Fisher's exact test.||27.1|-67.9|0.5455
71126731|NCT03429543|141759758|OTHER||Rate difference (percentage)|-23.3||||0.5455|TWO_SIDED|90.0|-67.9|27.1|||Fisher Exact||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and Fisher's exact test.||27.1|-67.9|0.5455
71126732|NCT03429543|141759759|OTHER||Rate difference (percentage)|2.4||||0.7789|TWO_SIDED|95.0|-15.2|19.5|||Wald test||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and two-sided Wald test.||19.5|-15.2|0.7789
71126733|NCT03429543|141759759|OTHER||Rate difference (percentage)|10.1||||0.2548|TWO_SIDED|95.0|-7.7|28.1|||Wald test||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and two-sided Wald test.||28.1|-7.7|0.2548
71126734|NCT03429543|141759759|OTHER||Rate difference (percentage)|-23.3||||0.5455|TWO_SIDED|90.0|-67.9|27.1|||Fisher Exact||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and Fisher's exact test.||27.1|-67.9|0.5455
71126735|NCT03429543|141759759|OTHER||Rate difference (percentage)|26.7||||0.5671|TWO_SIDED|90.0|-30.8|70.8|||Fisher Exact||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and Fisher's exact test.||70.8|-30.8|0.5671
71126736|NCT00651625|141759805|SUPERIORITY_OR_OTHER||non-applicable|||||0.05|TWO_SIDED||||||t-test, 2 sided|||group comparisons using t-test and confidence intervals.||||0.05
71126737|NCT04018313|141759813|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|105.62|||||TWO_SIDED|90.0|95.91|116.31||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||116.31|95.91|
71126738|NCT04018313|141759813|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax|Ratio of geometric least square means|98.72|||||TWO_SIDED|90.0|89.76|108.58||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||108.58|89.76|
71126739|NCT04018313|141759813|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|93.47|||||TWO_SIDED|90.0|85.09|102.68||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||102.68|85.09|
71126740|NCT04018313|141759814|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|104.0|||||TWO_SIDED|90.0|94.96|113.89||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||113.89|94.96|
70946414|NCT01983553|141393003|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|0.807|||||TWO_SIDED|95.0|0.53|1.25|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Any Serotype||1.25|0.53|
71126741|NCT04018313|141759814|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|99.3|||||TWO_SIDED|90.0|90.79|108.61||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||108.61|90.79|
71126742|NCT04018313|141759814|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|95.48|||||TWO_SIDED|90.0|87.36|104.37||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||104.37|87.36|
71126743|NCT04018313|141759815|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|113.14|||||TWO_SIDED|90.0|103.15|124.11||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||124.11|103.15|
71126744|NCT04018313|141759815|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|103.88|||||TWO_SIDED|90.0|94.83|113.8||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||113.80|94.83|
71126745|NCT04018313|141759815|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|91.82|||||TWO_SIDED|90.0|83.87|100.52||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||100.52|83.87|
71126746|NCT03927404|141759883|OTHER|We used median (Inter-quartile range) to describe the continuous measures of limb health such as TEWL, Hydration, and Oxygenation levels at each visit and each location of the measurements in the sound (SL) and residual limbs (RL).|||||<|0.05||||||In a bivariate analysis, we used two-sided equality of the median test for the matched pairs of observations|bivariate analysis|||||||<0.05
71126747|NCT03927404|141759885|OTHER|We used median (Inter-quartile range) to describe the continuous measures of limb health such as TEWL, Hydration, and Oxygenation levels at each visit and each location of the measurements in the sound (SL) and residual limbs (RL).||||||0.05||||||In a bivariate analysis, we used two-sided equality of the median test for the matched pairs of observations|bivariate analysis|||||||0.05
71126748|NCT01300260|141759911|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|2.96|||<|0.001|TWO_SIDED|95.0|2.41|3.64||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||3.64|2.41|<0.001
70857883|NCT00095238|141201766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.8|1.3|||Mixed Models Analysis|baseline score used as covariate; treatment, visit, treatment-by-visit, \& baseline angiotensin-converting enzyme (ACE) inhibitors used as predictors||Comparison of 2 treatment arms at Month 6 (first 2 columns)||1.3|-0.8|
70946415|NCT01983553|141393003|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 1 (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|4.885|||||TWO_SIDED|95.0|0.7|212.02|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Serotype 1||212.02|0.70|
70857884|NCT00095238|141201766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.5|1.7|||Mixed Models Analysis|baseline score used as covariate; treatment, visit, treatment-by-visit, \& baseline angiotensin-converting enzyme (ACE) inhibitors used as predictors||comparison of 2 treatment arms at Month 14 (columns 3 and 4)||1.7|-0.5|
71089720|NCT01462942|141685901|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.162|||<|0.0001|TWO_SIDED|95.0|0.593|1.73|||Mixed Models Analysis|||Adjusted by BDI baseline score and age as covariates, with treatment group, gender, smoking-status, visit, and group-by-visit as fixed effect factors||1.730|0.593|<0.0001
71089721|NCT01462942|141685902|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.653||||0.598|TWO_SIDED|95.0|-3.082|1.776|||Mixed Models Analysis|Adjusted by SGRQ baseline score and age as covariates, with treatment group, gender, smoking-status, visit, and group-by-visit as fixed effect factors||||1.776|-3.082|0.5980
71089722|NCT01462942|141685902|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.828||||0.1406|TWO_SIDED|95.0|-4.259|0.604|||Mixed Models Analysis|Adjusted by SGRQ baseline score and age as covariates, with treatment group, gender, smoking-status, visit, and group-by-visit as fixed effect factors||||0.604|-4.259|0.1406
71089723|NCT01027845|141685903|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1100 in the 105553 10Pn Group; GMC= 1.05 µg/mL with 95% CI = (1.00 to 1.10).|GMC ratio|0.16|||||TWO_SIDED|95.0|0.14|0.18||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 1."||0.18|0.14|
71089724|NCT01027845|141685903|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1106 in the 105553 10Pn Group; GMC= 1.45 µg/mL with 95% CI = (1.38 to 1.53).|GMC ratio|0.22|||||TWO_SIDED|95.0|0.2|0.25||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 4."||0.25|0.2|
71089725|NCT01027845|141685903|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1104 in the 105553 10Pn Group; GMC= 1.70 µg/mL with 95% CI = (1.62 to 1.78).|GMC ratio|0.26|||||TWO_SIDED|95.0|0.23|0.29||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 5."||0.29|0.23|
71089726|NCT01027845|141685903|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1100 in the 105553 10Pn Group; GMC= 0.33 µg/mL with 95% CI = (0.30 to 0.36).|GMC ratio|0.19|||||TWO_SIDED|95.0|0.16|0.23||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 6B."||0.23|0.16|
71089727|NCT01027845|141685903|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1107 in the 105553 10Pn Group; GMC= 1.72 µg/mL with 95% CI = (1.64 to 1.80).|GMC ratio|0.28|||||TWO_SIDED|95.0|0.25|0.31||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 7F."||0.31|0.25|
71089728|NCT01027845|141685903|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1103 in the 105553 10Pn Group; GMC= 1.32 µg/mL with 95% CI = (1.25 to 1.38).|GMC ratio|0.24|||||TWO_SIDED|95.0|0.22|0.27||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 9V."||0.27|0.22|
71126749|NCT01300260|141759911|SUPERIORITY_OR_OTHER||Geometric least squares (LS) means ratio|5.4|||<|0.001|TWO_SIDED|95.0|4.09|7.13||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||7.13|4.09|<0.001
70857885|NCT03505671|141201783|OTHER|||||||0.61|||||||ANCOVA|||||||0.61
70857886|NCT03505671|141201783|OTHER||Correlation Coefficient|0.15|||||TWO_SIDED||||||||Correlation between EORTC Sensory Subscale baseline and 12 weeks (overall, N=20)|||||
70857887|NCT03505671|141201783|OTHER||Correlation coefficient|0.25|||||TWO_SIDED||||||||Correlation between EORTC Sensory Subscale baseline and 12 weeks (intervention, N=9)|||||
70857888|NCT03505671|141201783|OTHER||Correlation coefficient|0.09|||||TWO_SIDED||||||||Correlation between EORTC Sensory Subscale baseline and 12 weeks (Usual Care, N=11)|||||
70857889|NCT03505671|141201784|OTHER|||||||0.91||||||P value for the motor subscale|ANCOVA|||||||0.91
70857890|NCT03505671|141201784|OTHER|||||||0.55||||||P value for autonomic subscale|ANCOVA|||||||0.55
70857891|NCT03505671|141201785|OTHER|||||||0.41||||||P value for baseline numbness or tingling severity data|Fisher Exact|||||||0.41
70857892|NCT03505671|141201785|OTHER|||||||0.22||||||P value for baseline numbness or tingling interference data|Fisher Exact|||||||0.22
70857893|NCT03505671|141201785|OTHER|||||||0.58||||||Week 12 p value for numbness or tingling severity data|Fisher Exact|||||||0.58
70946416|NCT01983553|141393003|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 1 (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|0.557|||||TWO_SIDED|95.0|0.21|1.46|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Serotype 1||1.46|0.21|
70946417|NCT01983553|141393003|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|2.931|||||TWO_SIDED|95.0|0.36|134.83|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Serotype 2||134.83|0.36|
70857894|NCT03505671|141201785|OTHER|||||||0.12||||||P value for Week 12 numbness or tingling interference data|Fisher Exact|||||||0.12
70857895|NCT03505671|141201785|OTHER|||||||0.57||||||Week 12 - Baseline p value for numbness or tingling severity data|Fisher Exact|||||||0.57
70857896|NCT03505671|141201785|OTHER|||||||0.55||||||Week 12 - Baseline p value for numbness or tingling interference|Fisher Exact|||||||0.55
71126750|NCT01300260|141759912|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|3.09|||<|0.001|TWO_SIDED|95.0|2.66|3.59||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||3.59|2.66|<0.001
70857897|NCT03505671|141201786|OTHER|||||||0.99||||||P value for baseline numbness or tingling severity Grade 1-3|Fisher Exact|||||||0.99
70857898|NCT03505671|141201786|OTHER|||||||0.99||||||P value for 12 weeks numbness or tingling severity Grade 1-3|Fisher Exact|||||||0.99
71126751|NCT01300260|141759912|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|7.92|||<|0.001|TWO_SIDED|95.0|4.82|13.0||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||13.0|4.82|<0.001
71126752|NCT01300260|141759913|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|4.15|||<|0.001|TWO_SIDED|95.0|3.45|5.0||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||5.00|3.45|<0.001
71126753|NCT01300260|141759913|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|3.78|||<|0.001|TWO_SIDED|95.0|2.99|4.78||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||4.78|2.99|<0.001
71126754|NCT01300260|141759914|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|2.04||||0.011|TWO_SIDED|95.0|1.26|3.31||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||3.31|1.26|0.011
71126755|NCT01300260|141759914|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|2.44|||<|0.001|TWO_SIDED|95.0|1.71|3.47||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||3.47|1.71|<0.001
71126756|NCT01300260|141759915|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|1.22||||0.021|TWO_SIDED|95.0|1.04|1.43||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||1.43|1.04|0.021
70857899|NCT03505671|141201786|OTHER|||||||0.99||||||P value for week 12 - baseline change in numbness or tingling severity|Fisher Exact|||||||0.99
70857900|NCT03505671|141201787|OTHER|||||||0.99|||||||Fisher Exact|||||||0.99
71126757|NCT01300260|141759915|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|1.39|||<|0.001|TWO_SIDED|95.0|1.27|1.53||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||1.53|1.27|<0.001
70857901|NCT03505671|141201788|OTHER|||||||0.69|||||||t-test, 2 sided|||||||0.69
70857902|NCT03505671|141201789|OTHER|||||||0.46||||||P value for cross sectional area sural data|ANCOVA|||||||0.46
70857903|NCT03505671|141201789|OTHER|||||||0.22||||||P value for cross sectional area for median data|ANCOVA|||||||0.22
70857904|NCT03505671|141201790|OTHER|||||||0.2||||||P value for amplitude - sural data|ANCOVA|||||||0.20
70857905|NCT03505671|141201790|OTHER|||||||0.28||||||P value for amplitude - tibial, ankle|ANCOVA|||||||0.28
70946418|NCT01983553|141393003|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|1.165|||||TWO_SIDED|95.0|0.53|2.74|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Serotype 2||2.74|0.53|
71126758|NCT01300260|141759916|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|1.43||||0.009|TWO_SIDED|95.0|1.14|1.8||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||1.80|1.14|0.009
70857906|NCT03505671|141201790|OTHER|||||||0.13||||||P value for amplitude tibial, pop fossa|ANCOVA|||||||0.13
70857907|NCT03505671|141201790|OTHER|||||||0.71||||||P value for amplitude median, wrist|ANCOVA|||||||0.71
70857908|NCT03505671|141201790|OTHER|||||||0.46||||||P value for amplitude, median, elbow|ANCOVA|||||||0.46
70857909|NCT03505671|141201791|OTHER|||||||0.81||||||P value for latency sural data|ANCOVA|||||||0.81
70857910|NCT03505671|141201791|OTHER|||||||0.76||||||P value for latency tibial, ankle data|ANCOVA|||||||0.76
70857911|NCT03505671|141201791|OTHER|||||||0.24||||||P value for latency tibial, pop fossa|ANCOVA|||||||0.24
70857912|NCT03505671|141201791|OTHER|||||||0.2||||||P value for latency median wrist data|ANCOVA|||||||0.20
70857913|NCT03505671|141201791|OTHER|||||||0.51||||||P value for latency median elbow data|ANCOVA|||||||0.51
70857914|NCT03505671|141201792|OTHER|||||||0.98||||||P value for velocity sural data|ANCOVA|||||||0.98
70857915|NCT03505671|141201792|OTHER|||||||0.03||||||P value for velocity tibial data|ANCOVA|||||||0.03
70857916|NCT03505671|141201792|OTHER|||||||0.81||||||P value for velocity median data|ANCOVA|||||||0.81
71126759|NCT01300260|141759916|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|1.75|||<|0.001|TWO_SIDED|95.0|1.59|1.94||P-value is 2-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||1.94|1.59|<0.001
71126760|NCT00439374|141759924|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.79|1.35||||||All deliveries less than 37 weeks||1.35|0.79|
71126761|NCT00439374|141759924|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.7|1.4||||||Spontaneous deliveries||1.40|0.70|
71126762|NCT00439374|141759924|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.65|1.84||||||Medically-indicated deliveries||1.84|0.65|
71126763|NCT00439374|141759925|SUPERIORITY_OR_OTHER|||||||0.93|||||||Wilcoxon (Mann-Whitney)|||||||0.93
71126764|NCT00439374|141759926|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.61|1.8||||||||1.80|0.61|
71126765|NCT00439374|141759927|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.58|1.21||||||||1.21|0.58|
71126766|NCT00439374|141759928|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.54|1.43||||||||1.43|0.54|
71126767|NCT00439374|141759929|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.69|||||TWO_SIDED|95.0|0.36|1.3||||||||1.30|0.36|
71126768|NCT00439374|141759930|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.82|1.15||||||||1.15|0.82|
70872020|NCT01652703|141229475|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-58.16|STANDARD_ERROR_OF_MEAN|3.21|<|0.001|TWO_SIDED|95.0|-64.51|-51.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-51.81|-64.51|<0.001
70872021|NCT01652703|141229476|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-96.3|STANDARD_ERROR_OF_MEAN|4.9|<|0.001|TWO_SIDED|95.0|-106.0|-86.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-86.5|-106.0|<0.001
71126769|NCT00439374|141759931|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.55|1.29||||||||1.29|0.55|
71126770|NCT00439374|141759932|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.77|1.55||||||||1.55|0.77|
71126771|NCT00439374|141759933|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.52|||||TWO_SIDED|95.0|0.43|5.33||||||||5.33|0.43|
71126772|NCT00439374|141759934|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.78|1.72||||||||1.72|0.78|
71126773|NCT00439374|141759935|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.56|2.41||||||||2.41|0.56|
71126774|NCT00439374|141759937|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.74|||||TWO_SIDED|95.0|0.34|1.58||||||||1.58|0.34|
71126775|NCT00439374|141759938|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.45|||||TWO_SIDED|95.0|0.84|2.52||||||||2.52|0.84|
71126776|NCT00439374|141759939|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07|||||TWO_SIDED|95.0|0.79|1.46||||||||1.46|0.79|
71126777|NCT00439374|141759940|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|0.92|1.13||||||Any side effect||1.13|0.92|
71126778|NCT00439374|141759940|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.04|||||TWO_SIDED|95.0|0.93|1.17||||||Injection site||1.17|0.93|
71126779|NCT00439374|141759940|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|5.03|||||TWO_SIDED|95.0|1.11|22.78||||||Urticaria||22.78|1.11|
71126780|NCT00439374|141759940|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7|||||TWO_SIDED|95.0|0.27|1.83||||||Nausea||1.83|0.27|
71126781|NCT00439374|141759941|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.46|1.3||||||Analysis is for the total composite||1.30|0.46|
71126782|NCT00439374|141759942|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.82
71126783|NCT00439374|141759950|SUPERIORITY_OR_OTHER|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||||||0.61
71126784|NCT02533726|141759952|SUPERIORITY||Odds Ratio (OR)|0.27||||0.012|TWO_SIDED|95.0|0.1|0.75|||Fisher Exact|||Per-protocol (PP) analysis, consistent with regulatory guidance (FDA).||.75|.1|.012
71126785|NCT02533726|141759952|OTHER||Odds Ratio (OR)|0.2||||0.015|TWO_SIDED|95.0|0.06|0.74|||Fisher Exact|||Per protocol analysis adjusted for admitting team, unit of admission, and risk for pressure injury.||0.74|0.06|0.015
71126786|NCT01147848|141759954|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.037||||0.162|TWO_SIDED|95.0|-0.088|0.015|||ANCOVA||Analysis was performed using ANCOVA with covariates of Baseline FEV1, region, sex, age, and treatment.|||0.015|-0.088|0.162
71126787|NCT03596450|141759978|SUPERIORITY||Treatment effect|1.36||||0.033|TWO_SIDED|95.0|1.03|1.79|||Regression, Logistic|||Estimate and p-value are based on logistic regression model with logit link function, treatment as categorical effect, and baseline HbA1c as covariate.||1.79|1.03|0.033
71126788|NCT02332291|141760047|SUPERIORITY||Odds Ratio, log|0.8642|STANDARD_ERROR_OF_MEAN|0.475||0.0689|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was \< 0.05.|Regression, Logistic|||Statistical analyses utilized a logistic regression model with remission status (defined as final MADRS \<= 7) as the dependent variable. The independent variable of interest was treatment arm assignment, and the model included age, sex, and baseline depression severity by MADRS as covariates.||||0.0689
71126789|NCT02332291|141760048|SUPERIORITY||Slope, fixed effect|-1.066|STANDARD_ERROR_OF_MEAN|0.264||0.0001|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|344 degrees of freedom||Statistical analyses utilized mixed model. MADRS score was the repeated measures dependent variable. Independent variables included time, age, sex, and treatment assignment. The primary variable of interest for this analysis was an interaction term between time and treatment assignment. A statistically significant interaction term would indicate that one treatment arm experienced a greater change in MADRS score over time than the other treatment arm.||||0.0001
71126790|NCT02332291|141760049|SUPERIORITY||Slope, fixed effects|-0.3117|STANDARD_ERROR_OF_MEAN|0.1566||0.0483|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|150 degrees of freedom||Statistical analyses utilized mixed models, with QIDS score being the repeated measures dependent variable. Independent variables included time, age, sex, and treatment assignment. The primary variable of interest was an interaction term between time and treatment assignment.||||0.0483
71126791|NCT02332291|141760050|OTHER|Analyses tested for effects of time in this one-arm, open-label study phase.|Slope, fixed effect|-1.186|STANDARD_ERROR_OF_MEAN|0.181|<|0.0001|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|128 degrees of freedom||Statistical analyses utilized mixed models, with MADRS score being the repeated measures dependent variable. Independent variables included time, age, and sex. The primary variable of interest was time, to indicate a change in depression severity over time with open-label treatment.||||<0.0001
71126792|NCT02332291|141760051|OTHER|Analyses tested for effects of time in this one-arm, open-label study phase.|Slope, fixed effects|-0.2342|STANDARD_ERROR_OF_MEAN|0.0908||0.0123|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|61 degrees of freedom||Statistical analyses utilized mixed models, with QIDS score being the repeated measures dependent variable. Independent variables included time, age, and sex. The primary variable of interest was time, to indicate a change in depression severity over time with open-label treatment.||||0.0123
71089729|NCT01027845|141685903|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1100 in the 105553 10Pn Group; GMC= 2.90 µg/mL with 95% CI = (2.75 to 3.05).|GMC ratio|0.29|||||TWO_SIDED|95.0|0.25|0.33||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 14."||0.33|0.25|
71089730|NCT01027845|141685903|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1102 in the 105553 10Pn Group; GMC= 1.66 µg/mL with 95% CI = (1.56 to 1.77).|GMC ratio|0.1|||||TWO_SIDED|95.0|0.09|0.12||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 18C."||0.12|0.09|
71126793|NCT02332291|141760052|SUPERIORITY||Slope|-0.636|STANDARD_ERROR_OF_MEAN|1.924||0.742|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was p \< 0.05.|Regression, Linear|||Statistical analyses used a linear model. Final AES score at week 8 was the dependent variable. Independent variables included age, sex, baseline AES score, baseline MADRS score, and treatment assignment. Treatment assignment was the independent variable of interest.||||0.742
71126794|NCT02332291|141760053|SUPERIORITY||Slope|-5.4705|STANDARD_ERROR_OF_MEAN|2.352||0.0232|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was p \< 0.05.|Regression, Linear|||Statistical analyses used a linear regression model. Final RRS score at week 8 was the dependent variable. Independent variables included age, sex, baseline RRS score, baseline MADRS score, and treatment assignment. Treatment assignment was the independent variable of interest.||||0.0232
71126795|NCT02262754|141760064|SUPERIORITY_OR_OTHER||Mean Difference (PF-06372865-Placebo)|0.16|||||TWO_SIDED|90.0|-0.28|0.6||||||An analysis of covariance (ANCOVA) model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-2.36, 0.542\^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. A last observation carried forward (LOCF) was used for missing data.||0.60|-0.28|
71126796|NCT02262754|141760064|SUPERIORITY_OR_OTHER||Mean Difference (PF-06372865-Naproxen)|0.42|||||TWO_SIDED|90.0|-0.02|0.87||||||An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-2.36, 0.542\^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. A last observation carried forward LOCF was used for missing data.||0.87|-0.02|
71126797|NCT02262754|141760064|SUPERIORITY_OR_OTHER||Mean Difference (Naproxen-Placebo)|-0.26|||||TWO_SIDED|90.0|-0.7|0.18||||||An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-2.36, 0.542\^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. A last observation carried forward LOCF was used for missing data.||0.18|-0.70|
71126798|NCT02262754|141760070|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.23|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|-0.76|0.3||||||The ANCOVA model included treatment as fixed effects.||0.30|-0.76|
71126799|NCT02262754|141760070|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|0.12|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|-0.41|0.65||||||The ANCOVA model included treatment as fixed effects.||0.65|-0.41|
71126800|NCT02262754|141760070|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|-0.35|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|-0.87|0.17||||||The ANCOVA model included treatment as fixed effects.||0.17|-0.87|
71126801|NCT02262754|141760071|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.08|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.2|0.36||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.36|-0.20|
71126802|NCT02262754|141760071|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.2|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.48|0.07||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.07|-0.48|
71126803|NCT02262754|141760071|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.28|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|0.01|0.56||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.56|0.01|
71126804|NCT02262754|141760071|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.05|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-0.43|0.34||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.34|-0.43|
71126805|NCT02262754|141760071|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.24|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.62|0.15||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.15|-0.62|
70857917|NCT02038829|141201820|SUPERIORITY|A sample size of 66 subjects (rounding to 72 for using Williams squares and 96 with dropouts) provides \~90% power to detect a 100 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in trough FEV1 of 176 and a within-subject correlation of 0.3.|LS Mean (SE)|0.0126|STANDARD_ERROR_OF_MEAN|0.0225||0.973|TWO_SIDED|95.0|-0.0318|0.0569||P-values were adjusted using Dunnett's method for comparing the multiple treatments to placebo. The comparison of aclidinium to placebo was performed at the 0.05 significance level to establish assay sensitivity.|LS Mean (SE)|||An mixed effects model was used with mean change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.0569|-0.0318|0.9730
70946419|NCT01983553|141393003|OTHER|Relative risk analysis of the event rate per 100 participants at Year 1 for Serotype 3 (4 to 5 year) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|1.221|||||TWO_SIDED|95.0|0.2|12.83|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Serotype 3||12.83|0.20|
71089731|NCT01027845|141685903|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1104 in the 105553 10Pn Group; GMC= 1.84 µg/mL with 95% CI = (1.71 to 1.98).|GMC ratio|0.11|||||TWO_SIDED|95.0|0.09|0.12||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 19F."||0.12|0.09|
71089732|NCT01027845|141685903|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1102 in the 105553 10Pn Group; GMC= 0.53 µg/mL with 95% CI = (0.50 to 0.57).|GMC ratio|0.25|||||TWO_SIDED|95.0|0.21|0.29||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 23F."||0.29|0.21|
71089733|NCT00997893|141685946|OTHER|||||||0.004||||||treatment x time p=.004|Mixed Models Analysis||||A mixed effects regression model (Estimation method=maximum likelihood; Random intercept) was conducted to compare the effects of phytoestrogens and estradiol to placebo. Primary predictor variables in the model included treatment and time, as well the treatment by time interaction.|||.004
71089734|NCT00997893|141685947|OTHER|||||||0.98||||||visit x time x treatment interaction p=.98|Mixed Models Analysis||||A mixed effects regression model (Estimation method=maximum likelihood; Random intercept) was conducted to compare the effects of phytoestrogens and estradiol to placebo before and after a psychosocial stressor. Predictor variables in the model included treatment, time (before and after the psychosocial stressor), visit (Baseline, 12 weeks), and all two and three way interactions.|||.98
71089735|NCT00997893|141685948|OTHER|||||||0.68||||||treatment x time (before and after the psychosocial stressor) x visit p=.68|Mixed Models Analysis||||A mixed effects regression model (Estimation method=maximum likelihood; Random intercept) was conducted to compare the effects of phytoestrogens and estradiol to placebo on emotional memory following a laboratory induced stress. Primary predictor variables in the model included treatment, time (before and after the psychosocial stressor), visit (Baseline, 12 weeks), and all two and three way interactions.|||.68
71089736|NCT00997893|141685949|OTHER|||||||0.11||||||treatment x time p=.11|Mixed Models Analysis||||A mixed effects regression model (Estimation method=maximum likelihood; Random intercept) was conducted to compare the effects of phytoestrogens and estradiol to placebo on verbal memory (logical memory; immediate). Primary predictor variables in the model included treatment and time, as well the treatment by time interaction.|||.11
71089737|NCT00997893|141685950|OTHER|||||||0.86||||||treatment x time p=.86|Mixed Models Analysis||||A mixed effects regression model (Estimation method=maximum likelihood; Random intercept) was conducted to compare the effects of phytoestrogens and estradiol to placebo on verbal memory (logical memory; immediate)Primary predictor variables in the model included treatment and time, as well the treatment by time interaction.|||.86
71089738|NCT00071981|141685951|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|95.0|||||Fisher Exact|||Compare CTL response rate among four arms. The null hypothesis is that CTL response is same in all four arms. Alternative hypothesis is that CTL response rate is different in at least one arm compared to other arms.||||<0.001
71126806|NCT02262754|141760071|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.19|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.19|0.58||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.58|-0.19|
71126807|NCT02262754|141760071|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.03|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.39|0.45||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.45|-0.39|
71126808|NCT02262754|141760071|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.27|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.69|0.16||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.16|-0.69|
71126809|NCT02262754|141760071|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.3|STANDARD_ERROR_OF_MEAN|0.25||||90.0|-0.12|0.71||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.71|-0.12|
71126810|NCT02262754|141760071|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.07|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-0.4|0.55||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.55|-0.40|
70872022|NCT01652703|141229476|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-75.5|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-85.4|-65.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-65.5|-85.4|<0.001
71126811|NCT02262754|141760071|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.37|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-0.84|0.11||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.11|-0.84|
71126812|NCT02262754|141760071|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.44|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-0.03|0.91||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.91|-0.03|
71126813|NCT02262754|141760072|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.03|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|90.0|-0.03|0.08||||||Week 1: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.08|-0.03|
71126814|NCT02262754|141760072|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.04|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|90.0|-0.09|0.02||||||Week 1: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.02|-0.09|
71126815|NCT02262754|141760072|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.06|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|90.0|0.01|0.12||||||Week 1: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.12|0.01|
71126816|NCT02262754|141760072|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.01|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|90.0|-0.09|0.1||||||Week 2: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.10|-0.09|
70872023|NCT01652703|141229476|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-88.2|STANDARD_ERROR_OF_MEAN|4.7|<|0.001|TWO_SIDED|95.0|-97.4|-79.0||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-79.0|-97.4|<0.001
71126817|NCT02262754|141760072|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.05|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|90.0|-0.15|0.05||||||Week 2: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.05|-0.15|
71126818|NCT02262754|141760072|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.06|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|90.0|-0.04|0.15||||||Week 2: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.15|-0.04|
71126819|NCT02262754|141760072|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.0|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.12|0.12||||||Week 3: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.12|-0.12|
71126820|NCT02262754|141760072|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.05|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.16|0.07||||||Week 3: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.07|-0.16|
70872024|NCT01652703|141229476|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-80.7|STANDARD_ERROR_OF_MEAN|4.7|<|0.001|TWO_SIDED|95.0|-90.0|-71.4||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-71.4|-90.0|<0.001
70872025|NCT01652703|141229477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1945.68|||<|0.001|TWO_SIDED|95.0|89.64|42232.63||Testing based on a significance level of 0.05.|Regression, Logistic|Logistic Regression model includes treatment arms in dose frequency of Q2W and stratification factor of screening LDL-C level.|Placebo is the reference|||42232.63|89.64|<0.001
71126821|NCT02262754|141760072|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.05|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.07|0.16||||||Week 3: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.16|-0.07|
71126822|NCT02262754|141760072|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.01|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.16|0.14||||||Week 4: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.14|-0.16|
71126823|NCT02262754|141760072|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.24|0.05||||||Week 4: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.05|-0.24|
71126824|NCT02262754|141760072|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.09|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.05|0.23||||||Week 4: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.23|-0.05|
71126825|NCT02262754|141760073|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97|||||TWO_SIDED|90.0|0.54|1.73||||||\>=30 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.||1.73|0.54|
71126826|NCT02262754|141760073|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43|||||TWO_SIDED|90.0|0.81|2.51||||||\>=30 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.||2.51|0.81|
71126827|NCT02262754|141760073|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68|||||TWO_SIDED|90.0|0.39|1.2||||||\>=30 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.||1.20|0.39|
71126828|NCT02262754|141760073|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81|||||TWO_SIDED|90.0|0.37|1.81||||||\>=50 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.||1.81|0.37|
71126829|NCT02262754|141760073|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11|||||TWO_SIDED|90.0|0.53|2.35||||||\>=50 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.||2.35|0.53|
71126830|NCT02262754|141760073|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73|||||TWO_SIDED|90.0|0.33|1.6||||||\>=50 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.||1.60|0.33|
71126831|NCT02262754|141760079|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.18|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-1.06|0.7||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.70|-1.06|
71126832|NCT02262754|141760079|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.91|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-1.8|-0.03||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||-0.03|-1.80|
71126833|NCT02262754|141760079|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.73|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-0.15|1.61||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||1.61|-0.15|
71126834|NCT02262754|141760079|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.7|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-1.69|0.29||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.29|-1.69|
71126835|NCT02262754|141760079|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-1.11|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-2.11|-0.11||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||-0.11|-2.11|
70857918|NCT02038829|141201820|SUPERIORITY|A sample size of 66 subjects (rounding to 72 for using Williams squares and 96 with dropouts) provides \~90% power to detect a 100 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in trough FEV1 of 176 and a within-subject correlation of 0.3.|LS Mean (SE)|0.0822|STANDARD_ERROR_OF_MEAN|0.0225||0.0014|TWO_SIDED|95.0|0.038|0.1264||P-values were adjusted using Dunnett's method for comparing the multiple treatments to placebo. The comparison of aclidinium to placebo was performed at the 0.05 significance level to establish assay sensitivity.|LS Mean (SE)|||An mixed effects model was used with mean change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.1264|0.0380|0.0014
71126836|NCT02262754|141760079|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.41|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|90.0|-0.57|1.39||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||1.39|-0.57|
71126837|NCT02262754|141760079|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.41|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|90.0|-1.42|0.6||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.60|-1.42|
71126838|NCT02262754|141760079|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-1.27|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|90.0|-2.28|-0.27||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||-0.27|-2.28|
71126839|NCT02262754|141760079|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.86|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-0.12|1.85||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||1.85|-0.12|
71126840|NCT02262754|141760080|SUPERIORITY_OR_OTHER||Mean Difference (PF-06372865-Placebo)|-0.64|||||TWO_SIDED|90.0|-1.63|0.35||||||Week 4: An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-3.28, 1.19\^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. LOCF was used for missing data.||0.35|-1.63|
71126841|NCT02262754|141760080|SUPERIORITY_OR_OTHER||Mean Difference (Naproxen-Placebo)|-1.43|||||TWO_SIDED|90.0|-2.4|-0.45||||||Week 4: An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-3.28, 1.19\^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. LOCF was used for missing data.||-0.45|-2.40|
71126842|NCT02262754|141760080|SUPERIORITY_OR_OTHER||Mean Difference (PF-06372865-Naproxen)|0.79|||||TWO_SIDED|90.0|-0.22|1.8||||||Week 4: An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-3.28, 1.19\^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. LOCF was used for missing data.||1.80|-0.22|
71126843|NCT02262754|141760081|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.37|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|90.0|-1.52|0.78||||||Total recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||0.78|-1.52|
71126844|NCT02262754|141760081|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.95|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|90.0|-2.1|0.2||||||Total recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||0.20|-2.10|
71126845|NCT02262754|141760081|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.58|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|90.0|-0.56|1.71||||||Total recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||1.71|-0.56|
71126846|NCT02262754|141760081|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-1.02|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|90.0|-2.06|0.02||||||Total Recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||0.02|-2.06|
71126847|NCT02262754|141760081|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-1.21|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|90.0|-2.25|-0.17||||||Total Recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||-0.17|-2.25|
71126848|NCT02262754|141760081|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.19|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|90.0|-0.82|1.19||||||Total Recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||1.19|-0.82|
71089739|NCT00071981|141685952|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|95.0|||||Fisher Exact|||Compare HTL response rate to 6MHP among four arms. The null hypothesis is that HTL response is same in all four arms. Alternative hypothesis is that HTL response rate is different in at least one arm compared to other arms.||||<0.001
71089740|NCT00071981|141685953|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|95.0|||||Fisher Exact|||Compare HTL response rate to tetanus peptide among four arms. The null hypothesis is that HTL response is same in all four arms. Alternative hypothesis is that HTL response rate is different in at least one arm compared to other arms.||||<0.001
71126849|NCT02262754|141760081|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.77|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|90.0|-1.39|-0.15||||||Delayed recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||-0.15|-1.39|
71126850|NCT02262754|141760081|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.17|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|90.0|-0.8|0.45||||||Delayed recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||0.45|-0.80|
71126851|NCT02262754|141760081|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|-0.6|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|90.0|-1.21|0.02||||||Delayed recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||0.02|-1.21|
71126852|NCT02262754|141760081|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.85|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-1.42|-0.28||||||Delayed recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||-0.28|-1.42|
71126853|NCT02262754|141760081|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.11|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.67|0.46||||||Delayed recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||0.46|-0.67|
71126854|NCT02262754|141760081|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|-0.74|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-1.29|-0.2||||||Delayed recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||-0.20|-1.29|
71126855|NCT02262754|141760082|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|90.0|0.61|1.58||||||A repeated measures logistic regression model included treatment and week as fixed effects and LBPI baseline as a covariate. Participant was included as a repeated effect.||1.58|0.61|
71126856|NCT02262754|141760082|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04|||||TWO_SIDED|90.0|1.33|3.14||||||A repeated measures logistic regression model included treatment and week as fixed effects and LBPI baseline as a covariate. Participant was included as a repeated effect.||3.14|1.33|
70872026|NCT01652703|141229477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|281.13|||<|0.001|TWO_SIDED|95.0|14.74|5360.92||Testing based on a significance level of 0.05.|Regression, Logistic|Logistic Regression model includes treatment arms in dose frequency of Q2W and stratification factor of screening LDL-C level.|Placebo is the reference|||5360.92|14.74|<0.001
70872027|NCT01652703|141229477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|536.45|||<|0.001|TWO_SIDED|95.0|28.37|10143.4||Testing based on a significance level of 0.05.|Regression, Logistic|Logistic Regression model includes treatment arms in dose frequency of Q4W and stratification factor of screening LDL-C level.|Placebo is the reference|||10143.40|28.37|<0.001
71126857|NCT02262754|141760082|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48|||||TWO_SIDED|90.0|0.31|0.74||||||A repeated measures logistic regression model included treatment and week as fixed effects and LBPI baseline as a covariate. Participant was included as a repeated effect.||0.74|0.31|
71126858|NCT02262754|141760083|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.01|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|90.0|-0.19|0.2||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.20|-0.19|
71126859|NCT02262754|141760083|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.14|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|90.0|-0.34|0.05||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.05|-0.34|
71126860|NCT02262754|141760083|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.15|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|90.0|-0.05|0.35||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.35|-0.05|
71126861|NCT02262754|141760083|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.04|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.26|0.18||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.18|-0.26|
71126862|NCT02262754|141760083|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.15|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.37|0.07||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.07|-0.37|
71126863|NCT02262754|141760083|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.11|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.1|0.33||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.33|-0.10|
71126864|NCT02262754|141760083|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.15|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|90.0|-0.09|0.38||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.38|-0.09|
71126865|NCT02262754|141760083|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|0.02|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|90.0|-0.21|0.25||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.25|-0.21|
71126866|NCT02262754|141760083|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.13|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|90.0|-0.1|0.36||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.36|-0.10|
71126867|NCT02262754|141760083|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.12|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.13|0.38||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.38|-0.13|
71126868|NCT02262754|141760083|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.21|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.46|0.05||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.05|-0.46|
71126869|NCT02262754|141760083|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.33|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.08|0.58||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.58|0.08|
71126870|NCT02262754|141760084|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.17|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.42|0.08||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.08|-0.42|
71126871|NCT02262754|141760084|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.37|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.62|-0.12||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||-0.12|-0.62|
71126872|NCT02262754|141760084|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.2|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.05|0.45||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.45|-0.05|
71126873|NCT02262754|141760084|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.08|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.38|0.21||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.21|-0.38|
71126874|NCT02262754|141760084|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.29|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.58|0.01||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.01|-0.58|
71126875|NCT02262754|141760084|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.2|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.09|0.49||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.49|-0.09|
71126876|NCT02262754|141760084|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.07|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.36|0.21||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.21|-0.36|
71126877|NCT02262754|141760084|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.38|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.67|-0.1||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||-0.10|-0.67|
71126878|NCT02262754|141760084|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.31|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|0.03|0.59||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.59|0.03|
71126879|NCT02262754|141760084|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.11|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.42|0.21||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.21|-0.42|
71126880|NCT02262754|141760084|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.43|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.75|-0.12||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||-0.12|-0.75|
71126881|NCT02262754|141760084|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.33|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|0.02|0.63||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.63|0.02|
71126882|NCT02262754|141760085|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85|||||TWO_SIDED|90.0|0.46|1.56||||||Odds Ratios were based on a logistic regression model and included treatment as a fixed effect.||1.56|0.46|
71126883|NCT02262754|141760085|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43|||||TWO_SIDED|90.0|0.23|0.81||||||Odds Ratios were based on a logistic regression model and included treatment as a fixed effect.||0.81|0.23|
71126884|NCT02262754|141760085|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.97|||||TWO_SIDED|90.0|1.06|3.65||||||Odds Ratios were based on a logistic regression model and included treatment as a fixed effect.||3.65|1.06|
71126885|NCT02577016|141760088|SUPERIORITY||Difference in least squares means|-0.83|||<|0.001|TWO_SIDED|95.0|-1.05|-0.62|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-0.62|-1.05|<0.001
71126886|NCT02577016|141760091|SUPERIORITY||Difference in least squares means|-42.5|||<|0.001|TWO_SIDED|95.0|-53.7|-31.2|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-31.2|-53.7|<0.001
71126887|NCT02577016|141760092|SUPERIORITY||Difference in least squares means|-67.0|||<|0.001|TWO_SIDED|95.0|-84.0|-50.0|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-50.0|-84.0|<0.001
71126888|NCT02577016|141760093|SUPERIORITY||Difference in least squares means|-11.2|||<|0.001|TWO_SIDED|95.0|-17.2|-5.2|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-5.2|-17.2|<0.001
71126889|NCT02126839|141760094|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|25.02|STANDARD_ERROR_OF_MEAN|4.52|<|0.0001|TWO_SIDED|95.0|16.1|33.94|||mixed model repeated measures analysis|Fixed effects of treatment group, treatment day, and study day by treatment interaction, with baseline measured at each study day as a covariate.||||33.94|16.10|<0.0001
70946420|NCT01983553|141393003|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 3 (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|1.013|||||TWO_SIDED|95.0|0.41|2.73|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Serotype 3||2.73|0.41|
71126890|NCT02126839|141760095|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|76.33|STANDARD_ERROR_OF_MEAN|14.47|<|0.0001|TWO_SIDED|95.0|47.76|104.91|||mixed model repeated measures|Fixed effects of treatment group, treatment day, and study day by treatment interaction, with baseline measured at each study day as a covariate.||||104.91|47.76|<0.0001
71126891|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.17||||1|TWO_SIDED|95.0|0.083|0.359|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||0.359|0.083|1.000
71126892|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.23||||0.9999|TWO_SIDED|95.0|0.111|0.492|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||0.492|0.111|0.9999
71126893|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.26||||0.9997|TWO_SIDED|95.0|0.121|0.568|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||0.568|0.121|0.9997
71126894|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.31||||0.9997|TWO_SIDED|95.0|0.136|0.66|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||0.660|0.136|0.9997
70946421|NCT01983553|141393003|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|0.977|||||TWO_SIDED|95.0|0.21|6.04|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Serotype 4||6.04|0.21|
71126895|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.29||||0.9991|TWO_SIDED|95.0|0.133|0.632|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||0.632|0.133|0.9991
71126896|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.46||||0.9631|TWO_SIDED|95.0|0.213|1.081|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.081|0.213|0.9631
71126897|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.33||||0.9941||95.0|0.157|0.789|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||0.789|0.157|0.9941
70872028|NCT01652703|141229477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|595.59|||<|0.001|TWO_SIDED|95.0|31.11|11402.67||Testing based on a significance level of 0.05.|Regression, Logistic|Logistic Regression model includes treatment arms in dose frequency of Q4W and stratification factor of screening LDL-C level.|Placebo is the reference|||11402.67|31.11|<0.001
71126898|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.38||||0.9875|TWO_SIDED|95.0|0.179|0.891|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||0.891|0.179|0.9875
71126899|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.33||||0.9956|TWO_SIDED|95.0|0.151|0.759|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||0.759|0.151|0.9956
71126900|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.34||||0.9964|TWO_SIDED|95.0|0.157|0.747|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||0.747|0.157|0.9964
71126901|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.25||||0.9999|TWO_SIDED|95.0|0.114|0.532|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||0.532|0.114|0.9999
71126902|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.29||||0.9991|TWO_SIDED|95.0|0.13|0.647|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||0.647|0.130|0.9991
71126903|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.36||||0.9852|TWO_SIDED|0.9852|0.137|0.906|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 96 hours||0.906|0.137|0.9852
71126904|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.51||||0.9719|TWO_SIDED|95.0|0.23|1.014|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.014|0.230|0.9719
71126905|NCT01597635|141760169|SUPERIORITY||Ratio of Active/Placebo|3.98||||1|TWO_SIDED|95.0|2.263|6.919|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||6.919|2.263|1.0000
71126906|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|3.46||||1|TWO_SIDED|95.0|1.976|6.052|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||6.052|1.976|1.000
71126907|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|3.59||||1|TWO_SIDED|95.0|2.06|6.345|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||6.345|2.060|1.0000
71126908|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.82||||0.9806|TWO_SIDED|95.0|1.031|3.17|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||3.170|1.031|0.9806
70857919|NCT02038829|141201820|SUPERIORITY|A sample size of 66 subjects (rounding to 72 for using Williams squares and 96 with dropouts) provides \~90% power to detect a 100 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in trough FEV1 of 176 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1088|STANDARD_ERROR_OF_MEAN|0.0226|<|0.0001|TWO_SIDED|95.0|0.0644|0.1532||P-values were adjusted using Dunnett's method for comparing the multiple treatments to placebo. The comparison of aclidinium to placebo was performed at the 0.05 significance level to establish assay sensitivity.|LS Mean (SE)|||An mixed effects model was used with mean change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.1532|0.0644|<0.0001
70857920|NCT02038829|141201820|SUPERIORITY|A sample size of 66 subjects (rounding to 72 for using Williams squares and 96 with dropouts) provides \~90% power to detect a 100 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in trough FEV1 of 176 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1375|STANDARD_ERROR_OF_MEAN|0.0226|<|0.0001|TWO_SIDED|95.0|0.0931|0.1818||P-values were adjusted using Dunnett's method for comparing the multiple treatments to placebo. The comparison of aclidinium to placebo was performed at the 0.05 significance level to establish assay sensitivity.|LS Mean (SE)|||An mixed effects model was used with mean change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation||0.1818|0.0931|<0.0001
70857921|NCT02038829|141201820|SUPERIORITY|A sample size of 66 subjects (rounding to 72 for using Williams squares and 96 with dropouts) provides \~90% power to detect a 100 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in trough FEV1 of 176 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1567|STANDARD_ERROR_OF_MEAN|0.0226|<|0.0001|TWO_SIDED|95.0|0.1121|0.2012||P-values were adjusted using Dunnett's method for comparing the multiple treatments to placebo. The comparison of aclidinium to placebo was performed at the 0.05 significance level to establish assay sensitivity.|LS Mean (SE)|||An mixed effects model was used with mean change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.2012|0.1121|<0.0001
70857922|NCT02038829|141201821|SUPERIORITY|A sample size of 78 subjects (rounding to 84 for using Williams squares) provides \~80% power to detect a 55 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in AUC(0-12) of 143 and a within-subject correlation of 0.3.|LS Mean (SE)|0.0526|STANDARD_ERROR_OF_MEAN|0.0184||0.0046|TWO_SIDED|95.0|0.0163|0.0888|||LS Mean (SE)|||An mixed effects model was used with standardized FEV1 AUC(0-12) on Day 7 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.0888|0.0163|0.0046
70857923|NCT02038829|141201821|SUPERIORITY|A sample size of 78 subjects (rounding to 84 for using Williams squares) provides \~80% power to detect a 55 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in AUC(0-12) of 143 and a within-subject correlation of 0.3.|LS Mean (SE)|0.0842|STANDARD_ERROR_OF_MEAN|0.0185|<|0.0001|TWO_SIDED|95.0|0.0478|0.1206|||LS Mean (SE)|||An mixed effects model was used with standardized FEV1 AUC(0-12) on Day 7 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.1206|0.0478|<0.0001
71126909|NCT01597635|141760169|SUPERIORITY||Ratio of Active/Placebo|1.5||||0.9129|TWO_SIDED|95.0|0.828|2.636|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||2.636|0.828|0.9129
71126910|NCT01597635|141760169|SUPERIORITY||Ratio of Active/Placebo|1.92||||0.9891|TWO_SIDED|95.0|1.098|3.349|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||3.349|1.098|0.9891
71126911|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|2.29||||0.9983|TWO_SIDED|95.0|1.316|3.974|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||3.974|1.316|0.9983
71126912|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.94||||0.99|TWO_SIDED|95.0|1.112|3.359|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||3.359|1.112|0.9900
71126913|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.27||||0.7996|TWO_SIDED|95.0|0.729|2.163|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||2.163|0.729|0.7996
71126914|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.23||||0.7778|TWO_SIDED|95.0|0.718|2.087|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||2.087|0.718|0.7778
71126915|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.24||||0.773|TWO_SIDED|95.0|0.705|2.113|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||2.113|0.705|0.7730
71126916|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.45||||0.8951|TWO_SIDED|95.0|0.814|2.604|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||2.604|0.814|0.8951
71126917|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.57||||0.9324|TWO_SIDED|95.0|0.276|1.183|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 96 hours||1.183|0.276|0.9324
71126918|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.63||||0.8982|TWO_SIDED|95.0|0.351|1.257|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.257|0.351|0.8982
71126919|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|4.22||||0.9998|TWO_SIDED|95.0|1.91|8.905|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||8.905|1.910|0.9998
71126920|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|3.67||||0.9993|TWO_SIDED|95.0|1.689|7.97|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||7.970|1.689|0.9993
71126921|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|5.26||||1|TWO_SIDED|95.0|2.392|11.754|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||11.754|2.392|1.0000
71126922|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|2.25||||0.9713|TWO_SIDED|95.0|0.972|5.136|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||5.136|0.972|0.9713
71126923|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|2.19||||0.9649|TWO_SIDED|95.0|0.94|4.975|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||4.975|0.940|0.9649
71126924|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.59||||0.8749|TWO_SIDED|95.0|0.711|3.473|||Mixed Models Analysis|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||3.473|0.711|0.8749
71126925|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.99||||0.9566|TWO_SIDED|95.0|0.899|4.342|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||4.342|0.899|0.9566
71126926|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.91||||0.9549|TWO_SIDED|95.0|0.862|4.173|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||4.173|0.862|0.9549
71126927|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.81||||0.9275|TWO_SIDED|95.0|0.816|4.005|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||4.005|0.816|0.9275
71126928|NCT01597635|141760169|SUPERIORITY||Ratio of Active/Placebo|1.32||||0.7483|TWO_SIDED|95.0|0.584|3.007|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||3.007|0.584|0.7483
71126929|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.17||||0.648|TWO_SIDED|95.0|0.516|2.675|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||2.675|0.516|0.6480
71126930|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.76||||0.9038|TWO_SIDED|95.0|0.741|4.17|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||4.170|0.741|0.9038
70872029|NCT01652703|141229478|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-62.56|STANDARD_ERROR_OF_MEAN|2.68|<|0.001|TWO_SIDED|95.0|-67.85|-57.27||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-57.27|-67.85|<0.001
71126931|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.38||||0.7339|TWO_SIDED|95.0|0.49|3.915|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 96 hours||3.915|0.490|0.7339
71126932|NCT01597635|141760169|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.38||||0.7714|TWO_SIDED|95.0|0.651|3.321|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||3.321|0.651|0.7714
71126933|NCT01597635|141760170|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.07||||1|TWO_SIDED|95.0|0.032|0.14|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||0.140|0.032|1.0000
71126934|NCT01597635|141760170|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.1||||1|TWO_SIDED|95.0|0.048|0.209|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||0.209|0.048|1.0000
71126935|NCT01597635|141760170|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.11||||1|TWO_SIDED|95.0|0.054|0.243|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||0.243|0.054|1.0000
71126936|NCT01597635|141760170|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.25||||0.9996|TWO_SIDED|95.0|0.113|0.547|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||0.547|0.113|0.9996
71126937|NCT01597635|141760170|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.29||||0.9991|TWO_SIDED|95.0|0.13|0.634|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||0.634|0.130|0.9991
71126938|NCT01597635|141760170|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.32||||0.9979|TWO_SIDED|95.0|0.149|0.682|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||0.682|0.149|0.9979
71126939|NCT01597635|141760170|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.19||||1||95.0|0.091|0.417|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||0.417|0.091|1.0000
71126940|NCT01597635|141760170|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.25||||0.9998|TWO_SIDED|95.0|0.119|0.539|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||0.539|0.119|0.9998
71126941|NCT01597635|141760170|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.31||||0.9985|TWO_SIDED|95.0|0.141|0.666|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||0.666|0.141|0.9985
71126942|NCT01597635|141760170|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.34||||0.9977|TWO_SIDED|95.0|0.162|0.73|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||0.730|0.162|0.9977
71126943|NCT01597635|141760170|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.22||||0.9999|TWO_SIDED|95.0|0.105|0.468|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||0.468|0.105|0.9999
71126944|NCT01597635|141760170|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.26||||0.9996|TWO_SIDED|95.0|0.119|0.57|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||0.570|0.119|0.9996
71126945|NCT01597635|141760170|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.82||||0.6621|TWO_SIDED|95.0|0.319|2.136|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 96 hours||2.136|0.319|0.6621
70946422|NCT01983553|141393003|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|0.506|||||TWO_SIDED|95.0|0.18|1.44|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Serotype 4||1.44|0.18|
70946423|NCT01983553|141393003|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Unserotyped (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|0.0|||||TWO_SIDED|95.0|0.0|2.6|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Unserotyped||2.60|0.00|
70946424|NCT01983553|141393003|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Unserotyped (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|0.0|||||TWO_SIDED|95.0|0.0|19.75|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Unserotyped||19.75|0.00|
70946425|NCT01983553|141393011|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes; Any grade between the CYD Dengue vaccine group and the Control group.|Relative Risk|1.174|||||TWO_SIDED|95.0|0.27|7.03|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Any serotype; Any grade||7.03|0.27|
71089741|NCT00071981|141685954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.741|TWO_SIDED|95.0|||||Fisher Exact|||Compare objective response rate among four arms. The null hypothesis is that objective response rate is same in all four arms. Alternative hypothesis is that objective response rate is different in at least one arm compared to other arms.||||0.741
71089742|NCT00071981|141685955|SUPERIORITY_OR_OTHER_LEGACY|||||||0.532|TWO_SIDED|95.0|||||Log Rank|||Compare overall survival curves among four arms.||||0.532
71089743|NCT01123655|141685962|EQUIVALENCE|P less than 0.05 was the criteria for equivalence.||||||0.5179|||||||Fisher Exact|||Specified to be a reduction from baseline values of net IFNƔ concentration of ≥ 25% in αl(ll)-stimulated PBMC culture supernatants (calculated as αI(II)-IFNƔ-PBS IFNƔ in patients receiving APL A12 compared to placebo.||||0.5179
71089744|NCT01123655|141685962|EQUIVALENCE|Null hypothesis was that the response rate in the APL treated groups is not significantly difference from the 50% spontaneous response rate.||||||0.0114|||||||Exact Test|||||||0.0114
70872030|NCT01652703|141229478|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.46|STANDARD_ERROR_OF_MEAN|2.72|<|0.001|TWO_SIDED|95.0|-54.83|-44.08||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-44.08|-54.83|<0.001
70857924|NCT02038829|141201821|NON_INFERIORITY|A sample size of 78 subjects (rounding to 84 for using Williams squares) provides \~80% power to detect a 55 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in AUC(0-12) of 143 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1255|STANDARD_ERROR_OF_MEAN|0.0186|<|0.0001|TWO_SIDED|95.0|0.089|0.1621|||LS Mean (SE)|||An mixed effects model was used with standardized FEV1 AUC(0-12) on Day 7 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.1621|0.0890|<0.0001
71089745|NCT01123655|141685962|EQUIVALENCE|Null hypothesis was that the response rate in the placebo group is not significantly difference from the 50% spontaneous response rate.||||||0.4142|||||||Exact Test|||||||0.4142
70872031|NCT01652703|141229478|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-58.08|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|-63.93|-52.22||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-52.22|-63.93|<0.001
71089746|NCT01123655|141685964|EQUIVALENCE|P greater than 0.05 was the criteria for equivalence.|||||>|0.05||||||P value is applicable for baseline and follow-up data.|Mixed Models Analysis|||||||>0.05
71089747|NCT01123655|141685965|EQUIVALENCE|p value greater than 0.05 was the criteria for equivalence.|||||>|0.05||||||P value is applicable to IL-17a, IL-10, IL-1b, IL-9, IL-13, IL-5, IL-21, IL-6, TNFa, TGFb, MIP3a.|t-test, 2 sided|||||||>0.05
70946426|NCT01983553|141393011|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes; Grade I between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.252|||||TWO_SIDED|95.0|0.0|4.83|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Any serotype; Grade I||4.83|0.00|
71089748|NCT00833755|141685996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.274|||||||Kruskal-Wallis|||||||0.274
70946427|NCT01983553|141393011|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes Grade II between the CYD Dengue vaccine group and the Control group.|Relative Risk|2.012|||||TWO_SIDED|95.0|0.2|99.1|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Any serotype; Grade II||99.10|0.20|
71089749|NCT00833755|141685997|SUPERIORITY_OR_OTHER_LEGACY|||||||0.552|||||||Kruskal-Wallis|||||||0.552
71089750|NCT00833755|141685998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
71089751|NCT02439164|141685999|SUPERIORITY||Mean Difference (Net)|23.51|||<|0.01|TWO_SIDED|95.0|14.16|32.87|||t-test, 2 sided|bonferroni correction was used for post hoc analysis, P value less than 0.05 indicated statistical significance.|this described the difference during midazolam sedation between the glioma and control group without dividing into subgroups.||Oneway Analysis of Variance (ANOVA) was used to test the difference among hands in a certain time point. General linear model for repeated measures ANOVA was used to analyze the time difference of test before and after drug administration,|32.87|14.16|<0.01
71089752|NCT02343224|141686005|OTHER||Kaplan-Meier estimate|76.2|||||TWO_SIDED|95.0|52.1|100.0||||||This Kaplan-Meier estimate is the conditional probability of event-free survival among study participants at 12 and 24 months.||100|52.1|
71089753|NCT02343224|141686006|OTHER||Kaplan-Meier estimate|75.0|||||TWO_SIDED|95.0|50.3|100.0||||||This Kaplan-Meier estimate is the conditional probability of overall survival among participants at 12 and 24 months.||100|50.3|
71089754|NCT02908347|141686037|SUPERIORITY||Median Difference (Final Values)|0.64||||0.8785|TWO_SIDED|95.0|-2.09|3.36|||Wilcoxon (Mann-Whitney)|||||3.36|-2.09|0.8785
71089755|NCT02908347|141686040|SUPERIORITY|||||||1|||||||Fisher Exact|||PASI 30 - Day 29||||1
71089756|NCT02908347|141686040|SUPERIORITY|||||||1|||||||Fisher Exact|||PASI 50 - Day 29||||1
71089757|NCT02908347|141686040|SUPERIORITY|||||||0.5136|||||||Fisher Exact|||PASI 30 - Day 43||||0.5136
71089758|NCT02908347|141686040|SUPERIORITY|||||||1|||||||Fisher Exact|||PASI 50 - Day 43||||1
71126946|NCT01597635|141760170|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.79||||0.7085|TWO_SIDED|95.0|0.324|1.847|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.847|0.324|0.7085
71126947|NCT01597635|141760170|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.06||||1|TWO_SIDED|95.0|0.028|0.14|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||0.140|0.028|1.0000
71126948|NCT01597635|141760170|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.1||||1|TWO_SIDED|95.0|0.043|0.216|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||0.216|0.043|1.0000
71089759|NCT01420536|141686087|SUPERIORITY_OR_OTHER_LEGACY|||||||0.569|TWO_SIDED|95.0||||P values less than 0.05 would be considered statistically significant in this study.|Wilcoxon (Mann-Whitney)|||Statistical analysis was performed by a researcher who was unaware of all procedures performed. The questionnaire about denture satisfaction originated a general score that was compared using the Wilcoxon test, according to the two tested conditions.||||0.569
71089760|NCT01420536|141686088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.339|TWO_SIDED|95.0||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.339
71089761|NCT01420536|141686089|SUPERIORITY|||||||0.515||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.515
71089762|NCT01420536|141686090|SUPERIORITY_OR_OTHER_LEGACY|||||||0.485||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.485
71089763|NCT01420536|141686091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.111||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.111
71089764|NCT01420536|141686092|SUPERIORITY_OR_OTHER_LEGACY|||||||0.399||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.399
71089765|NCT01420536|141686093|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.550
71126949|NCT01597635|141760170|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.08||||1|TWO_SIDED|95.0|0.034|0.177|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||0.177|0.034|1.0000
71126950|NCT01597635|141760170|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.2||||0.9998|TWO_SIDED|95.0|0.086|0.453|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||0.453|0.086|0.9998
70946428|NCT01983553|141393011|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 Any grade between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.503|||||TWO_SIDED|95.0|0.01|39.49|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Serotype 2; Any grade||39.49|0.01|
70946429|NCT01983553|141393011|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 Grade I between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.503|||||TWO_SIDED|95.0|0.01|39.49|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Serotype 2; Grade I||39.49|0.01|
70946430|NCT01983553|141393011|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 Any grade between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.252|||||TWO_SIDED|95.0|0.0|4.83|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Serotype 4; Any grade||4.83|0.00|
70946431|NCT01983553|141393011|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 Grade I between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.0|||||TWO_SIDED|95.0|0.0|19.62|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Serotype 4; Grade I||19.62|0.00|
70946432|NCT01983553|141393011|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 Grade II between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.503|||||TWO_SIDED|95.0|0.01|39.49|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Serotype 4; Grade II||39.49|0.01|
70946433|NCT00469456|141393023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.07||95.0|-0.1|2.8|||ANCOVA|||The primary efficacy parameter was change from Baseline to Week 12 in FLCI total score. Missing FLCI total scores at Week 12 were imputed using the last-observation-carried-forward (LOCF) approach.||2.8|-0.1|0.070
71089766|NCT01420536|141686094|SUPERIORITY_OR_OTHER_LEGACY|||||||0.609||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.609
71089767|NCT01420536|141686095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.600
71089768|NCT01420536|141686096|SUPERIORITY_OR_OTHER_LEGACY|||||||0.611||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.611
71126951|NCT01597635|141760170|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.17||||0.9999|TWO_SIDED|95.0|0.075|0.4|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||0.400|0.075|0.9999
71089769|NCT01420536|141686097|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.044
71089770|NCT01420536|141686098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.677||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.677
71089771|NCT01420536|141686099|SUPERIORITY_OR_OTHER_LEGACY|||||||0.885||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.885
71126952|NCT01597635|141760170|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.4||||0.9863|TWO_SIDED|95.0|0.173|0.901|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||0.901|0.173|0.9863
70872032|NCT01652703|141229478|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-53.54|STANDARD_ERROR_OF_MEAN|2.99|<|0.001|TWO_SIDED|95.0|-59.46|-47.63||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-47.63|-59.46|<0.001
70946434|NCT00469456|141393024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9||||0.022||95.0|0.9|10.9|||ANCOVA|||The secondary efficacy parameter was change from Baseline at Week 12 in the total score of the Social Communication subscale and Communication of Basic Needs subscale of the ASHA FACS. Missing scores at week 12 were imputed using the last-observation-carried-forward (LOCF) approach.||10.9|0.9|0.022
70946435|NCT00846768|141393215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.015|STANDARD_ERROR_OF_MEAN|0.015||0.3011||95.0|-0.014|0.044|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.044|-0.014|0.3011
71089772|NCT03054428|141686100|SUPERIORITY||percentage difference|22.0|||<|0.0001|TWO_SIDED|95.0|12.2|31.87||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Analysis was performed using Cochran-Mantel-Haenszel (CMH) test stratified by baseline disease severity (IGA=3 vs IGA=4) and baseline weight group (less than \[\<\] 60 kilogram \[kg\] vs greater than or equal to \[≥\] 60 kg).||31.87|12.2|< 0.0001
70857925|NCT02038829|141201821|SUPERIORITY|A sample size of 78 subjects (rounding to 84 for using Williams squares) provides \~80% power to detect a 55 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in AUC(0-12) of 143 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1963|STANDARD_ERROR_OF_MEAN|0.0184|<|0.0001|TWO_SIDED|95.0|0.1601|0.2325|||LS Mean (SE)|||An mixed effects model was used with standardized FEV1 AUC(0-12) on Day 7 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.2325|0.1601|<0.0001
70857926|NCT02038829|141201821|SUPERIORITY|A sample size of 78 subjects (rounding to 84 for using Williams squares) provides \~80% power to detect a 55 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in AUC(0-12) of 143 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1902|STANDARD_ERROR_OF_MEAN|0.0186|<|0.0001|TWO_SIDED|95.0|0.1537|0.2268|||LS Mean (SE)|||An mixed effects model was used with standardized FEV1 AUC(0-12) on Day 7 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.2268|0.1537|<0.0001
70857927|NCT00075270|141201824|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.87||||0.142|TWO_SIDED|95.0|0.72|1.05||P-value from stratified log-rank test, stratifying for stage of disease and site of disease at screening|Log Rank||The estimate of the treatment hazard ratio is based on the log-rank test.|||1.05|0.72|0.142
71089773|NCT03054428|141686100|SUPERIORITY||percentage difference|15.5|||=|0.0007|TWO_SIDED|95.0|6.7|24.31||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Analysis was performed using CMH test stratified by baseline disease severity (IGA=3 vs IGA=4) and baseline weight group (\<60 kg vs ≥60 kg).||24.31|6.7|= 0.0007
71089774|NCT03054428|141686101|SUPERIORITY||percentage difference|33.2|||<|0.0001|TWO_SIDED|95.0|21.07|45.39||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Analysis was performed using CMH test stratified by baseline disease severity (IGA=3 vs IGA=4) and baseline weight group (\<60 kg vs ≥60 kg).||45.39|21.07|< 0.0001
71089775|NCT03054428|141686101|SUPERIORITY||percentage difference|29.9|||<|0.0001|TWO_SIDED|95.0|17.94|41.78||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Analysis was performed using CMH test stratified by baseline disease severity (IGA=3 vs IGA=4) and baseline weight group (\<60 kg vs ≥60 kg).||41.78|17.94|< 0.0001
71089776|NCT03054428|141686102|SUPERIORITY||Least Square (LS) Mean difference|-42.3|||<|0.0001|TWO_SIDED|95.0|-55.6|-29.04||Threshold for significance at 0.05 level.|ANCOVA|||A hierarchical testing procedure was used to control type I error. The confidence interval (CI) with p-value is based on treatment difference (Dupilumab group vs. Placebo) of the LS mean percent change using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment, randomization strata (baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\]) as fixed factors.||-29.04|-55.6|< 0.0001
71089777|NCT03054428|141686102|SUPERIORITY||LS Mean difference|-41.2|||<|0.0001|TWO_SIDED|95.0|-54.44|-28.02||Threshold for significance at 0.05 level.|ANCOVA|||A hierarchical testing procedure was used to control type I error. The confidence interval (CI) with p-value is based on treatment difference (Dupilumab group vs. Placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata (baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\]) as fixed factors.||-28.02|-54.44|< 0.0001
71089778|NCT03054428|141686103|SUPERIORITY||LS Mean difference|-29.0|||<|0.0001|TWO_SIDED|95.0|-39.54|-18.38||Threshold for significance at 0.05 level.|ANCOVA|||A hierarchical testing procedure was used to control type I error. The confidence interval (CI) with p-value is based on treatment difference (Dupilumab group vs. Placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata (baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\]) as fixed factors.||-18.38|-39.54|< 0.0001
71126953|NCT01597635|141760170|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.24||||0.9998|TWO_SIDED|95.0|0.103|0.529|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||0.529|0.103|0.9998
71126954|NCT01597635|141760170|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.28||||0.9992|TWO_SIDED|95.0|0.119|0.626|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||0.626|0.119|0.9992
71126955|NCT01597635|141760170|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.24||||0.9995|TWO_SIDED|95.0|0.102|0.561|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||0.561|0.102|0.9995
71126956|NCT01597635|141760170|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.31||||0.9964|TWO_SIDED|95.0|0.131|0.729|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||0.729|0.131|0.9964
71126957|NCT01597635|141760170|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.25||||0.9995|TWO_SIDED|95.0|0.107|0.584|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||0.584|0.107|0.9995
71126958|NCT01597635|141760170|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.24||||0.9993|TWO_SIDED|95.0|0.098|0.578|||Ratio of Active/Placebo|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||0.578|0.098|0.9993
71126959|NCT01597635|141760170|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.34||||0.9781|TWO_SIDED|95.0|0.119|0.969|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 96 hours||0.969|0.119|0.9781
71126960|NCT01597635|141760170|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.38||||0.9375|TWO_SIDED|95.0|0.154|1.341|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.341|0.154|0.9375
70857928|NCT00075270|141201825|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.82||||0.094|TWO_SIDED|95.0|0.65|1.04||P-value from stratified log-rank test, stratifying for stage of disease and site of disease at screening|Log Rank||The estimate of the treatment hazard ratio was based on the log-rank test.|||1.04|0.65|0.094
71089779|NCT03054428|141686103|SUPERIORITY||LS Mean difference|-26.5|||<|0.0001|TWO_SIDED|95.0|-37.45|15.63||Threshold for significance at 0.05 level.|ANCOVA|||A hierarchical testing procedure was used to control type I error. The confidence interval (CI) with p-value is based on treatment difference (Dupilumab group vs. Placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata (baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\]) as fixed factors.||15.63|-37.45|< 0.0001
71089780|NCT03054428|141686104|SUPERIORITY||percentage difference|39.4|||<|0.0001|TWO_SIDED|95.0|26.9|51.84||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Difference is Dupilumab minus Placebo. C.I. = Confidence interval calculated using normal approximation. P-values were derived by CMH test stratified by baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\].||51.84|26.9|< 0.0001
71089781|NCT03054428|141686104|SUPERIORITY||percentage difference|29.1|||<|0.0001|TWO_SIDED|95.0|16.97|41.32||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Difference is Dupilumab minus Placebo. C.I. = Confidence interval calculated using normal approximation. P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\].||41.32|16.97|< 0.0001
71089782|NCT03054428|141686105|SUPERIORITY||Percentage difference|31.8|||<|0.0001|TWO_SIDED|95.0|20.45|43.2||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Difference is Dupilumab minus Placebo. C.I. = Confidence interval calculated using normal approximation. P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\].||43.2|20.45|< 0.0001
71089783|NCT03054428|141686105|SUPERIORITY||Percentage difference|21.7|||=|0.0001|TWO_SIDED|95.0|11.21|32.28||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Difference is Dupilumab minus Placebo. C.I. = Confidence interval calculated using normal approximation. P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\].||32.28|11.21|= 0.0001
71089784|NCT03082729|141686172|SUPERIORITY|||||||0.612|||||||t-test, 2 sided|||||||0.612
71089785|NCT03082729|141686173|SUPERIORITY|||||||0.083|||||||t-test, 2 sided|||||||0.083
71089786|NCT03082729|141686174|SUPERIORITY|||||||0.617|||||||t-test, 2 sided|||||||0.617
71089787|NCT03082729|141686175|SUPERIORITY|||||||0.524|||||||t-test, 2 sided|||||||0.524
71089788|NCT03082729|141686176|SUPERIORITY|||||||0.972|||||||t-test, 2 sided|||||||0.972
71089789|NCT03082729|141686177|SUPERIORITY|||||||0.315|||||||t-test, 2 sided|||||||0.315
71089790|NCT03082729|141686178|SUPERIORITY|||||||0.443|||||||t-test, 2 sided|||||||0.443
71089791|NCT03082729|141686179|SUPERIORITY|||||||0.027|||||||t-test, 2 sided|||||||0.027
71089792|NCT03082729|141686180|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||||||0.390
70857929|NCT03490981|141201858|SUPERIORITY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.47||0.486|TWO_SIDED||||||ANCOVA|||||||.486
70857930|NCT03490981|141201859|SUPERIORITY||Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|1.16||0.342|TWO_SIDED||||||ANCOVA|||||||.342
70857931|NCT03490981|141201860|SUPERIORITY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|1.31||0.646|TWO_SIDED||||||ANCOVA|||||||.646
71089793|NCT03082729|141686181|SUPERIORITY|||||||0.116|||||||t-test, 2 sided|||||||0.116
71089794|NCT03082729|141686182|SUPERIORITY|||||||0.331|||||||t-test, 2 sided|||||||0.331
71089795|NCT03082729|141686183|SUPERIORITY|||||||0.225|||||||t-test, 2 sided|||||||0.225
71089796|NCT03082729|141686184|SUPERIORITY|||||||0.141|||||||t-test, 2 sided|||||||0.141
71089797|NCT03082729|141686185|SUPERIORITY|||||||0.882|||||||t-test, 2 sided|||||||0.882
71089798|NCT03082729|141686186|SUPERIORITY|||||||0.326|||||||t-test, 2 sided|||||||0.326
71089799|NCT03082729|141686187|SUPERIORITY|||||||0.094|||||||t-test, 2 sided|||||||0.094
71089800|NCT03082729|141686188|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|||||||0.087
71089801|NCT03082729|141686189|SUPERIORITY|||||||0.771|||||||t-test, 2 sided|||||||0.771
71089802|NCT03082729|141686190|SUPERIORITY|||||||0.491|||||||t-test, 2 sided|||||||0.491
71089803|NCT03082729|141686191|SUPERIORITY|||||||0.924|||||||t-test, 2 sided|||||||0.924
71089804|NCT03082729|141686192|SUPERIORITY|||||||0.868|||||||t-test, 2 sided|||||||0.868
71089805|NCT03082729|141686193|SUPERIORITY|||||||0.922|||||||t-test, 2 sided|||||||0.922
71089806|NCT03082729|141686194|SUPERIORITY|||||||0.192|||||||t-test, 2 sided|||||||0.192
71089807|NCT03082729|141686195|SUPERIORITY|||||||0.453|||||||t-test, 2 sided|||||||0.453
71089808|NCT03082729|141686196|SUPERIORITY|||||||0.714|||||||t-test, 2 sided|||||||0.714
71089809|NCT03082729|141686197|SUPERIORITY|||||||0.434|||||||t-test, 2 sided|||||||0.434
71089810|NCT03082729|141686198|SUPERIORITY|||||||0.329|||||||t-test, 2 sided|||||||0.329
71089811|NCT03082729|141686199|SUPERIORITY|||||||0.963|||||||t-test, 2 sided|||||||0.963
71089812|NCT03082729|141686200|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||0.400
71089813|NCT03082729|141686201|SUPERIORITY|||||||0.223|||||||t-test, 2 sided|||||||0.223
71089814|NCT03082729|141686202|SUPERIORITY|||||||0.241|||||||t-test, 2 sided|||||||0.241
71089815|NCT03082729|141686203|SUPERIORITY|||||||0.348|||||||t-test, 2 sided|||||||0.348
71089816|NCT03082729|141686204|SUPERIORITY|||||||0.424|||||||t-test, 2 sided|||||||0.424
71089817|NCT03082729|141686205|SUPERIORITY|||||||0.667|||||||t-test, 2 sided|||||||0.667
71089818|NCT03082729|141686206|SUPERIORITY|||||||0.135|||||||t-test, 2 sided|||||||0.135
71089819|NCT03082729|141686207|SUPERIORITY|||||||0.331|||||||t-test, 2 sided|||||||0.331
71089820|NCT03082729|141686208|SUPERIORITY|||||||0.538|||||||t-test, 2 sided|||||||0.538
71089821|NCT03082729|141686209|SUPERIORITY|||||||0.791|||||||t-test, 2 sided|||||||0.791
71089822|NCT03082729|141686210|SUPERIORITY|||||||0.925|||||||t-test, 2 sided|||||||0.925
71089823|NCT03082729|141686211|SUPERIORITY|||||||0.161|||||||t-test, 2 sided|||||||0.161
71089824|NCT03082729|141686212|SUPERIORITY|||||||0.546|||||||t-test, 2 sided|||||||0.546
71089825|NCT03082729|141686213|SUPERIORITY|||||||0.667|||||||t-test, 2 sided|||||||0.667
71089826|NCT03082729|141686214|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.840
71089827|NCT03082729|141686215|SUPERIORITY|||||||0.367|||||||t-test, 2 sided|||||||0.367
70857932|NCT03490981|141201861|SUPERIORITY||Mean Difference (Final Values)|1.13|STANDARD_ERROR_OF_MEAN|0.205||0.205|TWO_SIDED||||||ANCOVA|||||||.205
70857933|NCT03490981|141201862|SUPERIORITY||Mean Difference (Final Values)|-2.05|STANDARD_ERROR_OF_MEAN|2.94||0.492|TWO_SIDED||||||ANCOVA|||||||.492
70857934|NCT03490981|141201863|SUPERIORITY||Mean Difference (Final Values)|4.31|STANDARD_ERROR_OF_MEAN|3.84||0.272|TWO_SIDED||||||ANCOVA|||||||.272
71089828|NCT03082729|141686216|SUPERIORITY|||||||0.773|||||||t-test, 2 sided|||||||0.773
71089829|NCT03082729|141686217|SUPERIORITY|||||||0.968|||||||t-test, 2 sided|||||||0.968
71089830|NCT03082729|141686218|SUPERIORITY|||||||0.953|||||||t-test, 2 sided|||||||0.953
71089831|NCT03082729|141686219|SUPERIORITY|||||||0.911|||||||t-test, 2 sided|||||||0.911
71089832|NCT03082729|141686220|SUPERIORITY|||||||0.944|||||||t-test, 2 sided|||||||0.944
71089833|NCT03082729|141686221|SUPERIORITY|||||||0.226|||||||t-test, 2 sided|||||||0.226
71089834|NCT03082729|141686222|SUPERIORITY|||||||0.988|||||||t-test, 2 sided|||||||0.988
70857935|NCT03490981|141201864|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|4.82||0.87|TWO_SIDED||||||ANCOVA|||||||.870
71089835|NCT03082729|141686223|SUPERIORITY|||||||0.189|||||||t-test, 2 sided|||||||0.189
71089836|NCT03082729|141686224|SUPERIORITY|||||||0.488|||||||t-test, 2 sided|||||||0.488
71089837|NCT03082729|141686225|SUPERIORITY|||||||0.523|||||||t-test, 2 sided|||||||0.523
71089838|NCT03082729|141686226|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.060
71089839|NCT03082729|141686227|SUPERIORITY|||||||0.777|||||||t-test, 2 sided|||||||0.777
71089840|NCT03082729|141686228|SUPERIORITY|||||||0.946|||||||t-test, 2 sided|||||||0.946
71089841|NCT03082729|141686229|SUPERIORITY|||||||0.351|||||||t-test, 2 sided|||||||0.351
71089842|NCT03082729|141686230|SUPERIORITY|||||||0.041|||||||t-test, 2 sided|||||||0.041
71089843|NCT03082729|141686231|SUPERIORITY|||||||0.884|||||||t-test, 2 sided|||||||0.884
71089844|NCT03082729|141686232|SUPERIORITY|||||||0.018|||||||t-test, 2 sided|||||||0.018
71089845|NCT03082729|141686233|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||||||0.046
71089846|NCT03082729|141686234|SUPERIORITY|||||||0.018|||||||t-test, 2 sided|||||||0.018
71089847|NCT03082729|141686235|SUPERIORITY|||||||0.283|||||||t-test, 2 sided|||||||0.283
71089848|NCT03082729|141686236|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.010
71089849|NCT03082729|141686237|SUPERIORITY|||||||0.371|||||||t-test, 2 sided|||||||0.371
71089850|NCT03082729|141686238|SUPERIORITY|||||||0.555|||||||t-test, 2 sided|||||||0.555
71089851|NCT03082729|141686239|SUPERIORITY|||||||0.533|||||||t-test, 2 sided|||||||0.533
71089852|NCT03082729|141686240|SUPERIORITY|||||||0.137|||||||t-test, 2 sided|||||||0.137
71089853|NCT03082729|141686241|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
71089854|NCT03082729|141686241|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|||||||0.015
71089855|NCT03082729|141686241|SUPERIORITY|||||||0.537|||||||t-test, 2 sided|||||||0.537
71089856|NCT03082729|141686242|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
71089857|NCT03082729|141686242|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.010
71089858|NCT03082729|141686242|SUPERIORITY|||||||0.918|||||||t-test, 2 sided|||||||0.918
71089859|NCT03082729|141686243|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71089860|NCT03082729|141686243|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70946436|NCT00846768|141393215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.015||0.1582||95.0|-0.008|0.05|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.050|-0.008|0.1582
70946437|NCT00846768|141393215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.015||0.0003||95.0|0.025|0.083|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.083|0.025|0.0003
70946438|NCT00846768|141393215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.015||0.7046||95.0|-0.034|0.023|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.023|-0.034|0.7046
71089861|NCT03082729|141686244|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71089862|NCT03082729|141686244|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71089863|NCT03082729|141686245|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71126961|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.93||||0.2598|TWO_SIDED|95.0|0.752|1.215|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||1.215|0.752|0.2598
71126962|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.97||||0.3949|TWO_SIDED|95.0|0.783|1.273|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 1 hour||1.273|0.783|0.3949
70946439|NCT00846768|141393215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.015||0.0248||95.0|0.004|0.063|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.063|0.004|0.0248
71089864|NCT03082729|141686245|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71089865|NCT03082729|141686246|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71089866|NCT03082729|141686246|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
71089867|NCT03082729|141686248|SUPERIORITY|||||||0.092|||||||t-test, 2 sided|||||||0.092
71126963|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.4175|TWO_SIDED|95.0|0.791|1.294|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||1.294|0.791|0.4175
71126964|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.442|TWO_SIDED|95.0|0.806|1.292|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 4 hours||1.292|0.806|0.4420
71126965|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4432|TWO_SIDED|95.0|0.811|1.262|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||1.262|0.811|0.4432
70857936|NCT03490981|141201865|SUPERIORITY||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|1.67||0.57|TWO_SIDED||||||ANCOVA|||||||.570
71089868|NCT03082729|141686248|SUPERIORITY|||||||0.678|||||||t-test, 2 sided|||||||0.678
71089869|NCT03082729|141686249|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.020
71089870|NCT03082729|141686249|SUPERIORITY|||||||0.762|||||||t-test, 2 sided|||||||0.762
71089871|NCT03082729|141686250|SUPERIORITY|||||||0.973|||||||t-test, 2 sided|||||||0.973
71089872|NCT03082729|141686250|SUPERIORITY|||||||0.805|||||||t-test, 2 sided|||||||0.805
71089873|NCT03082729|141686251|SUPERIORITY|||||||0.951|||||||t-test, 2 sided|||||||0.951
71089874|NCT03082729|141686251|SUPERIORITY|||||||0.661|||||||t-test, 2 sided|||||||0.661
71089875|NCT03082729|141686252|SUPERIORITY|||||||0.614|||||||t-test, 2 sided|||||||0.614
71089876|NCT03082729|141686252|SUPERIORITY|||||||0.306|||||||t-test, 2 sided|||||||0.306
71089877|NCT03082729|141686253|SUPERIORITY|||||||0.322|||||||t-test, 2 sided|||||||0.322
71089878|NCT03082729|141686253|SUPERIORITY|||||||0.032|||||||t-test, 2 sided|||||||0.032
71089879|NCT03082729|141686254|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.960
71089880|NCT03082729|141686254|SUPERIORITY|||||||0.268|||||||t-test, 2 sided|||||||0.268
71089881|NCT03082729|141686255|SUPERIORITY|||||||0.501|||||||t-test, 2 sided|||||||0.501
71089882|NCT03082729|141686255|SUPERIORITY|||||||0.235|||||||t-test, 2 sided|||||||0.235
71089883|NCT03082729|141686256|SUPERIORITY|||||||0.259|||||||t-test, 2 sided|||||||0.259
71089884|NCT03082729|141686256|SUPERIORITY|||||||0.219|||||||t-test, 2 sided|||||||0.219
71126966|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4578|TWO_SIDED|95.0|0.818|1.229|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 8 hours||1.229|0.818|0.4578
70857937|NCT00740051|141201881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.86|-0.29||No adjustment of p-values|ANCOVA|||Linagliptin versus Placebo||-0.29|-0.86|<0.0001
70857938|NCT00740051|141201882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.88|-0.32||No adjustment of p-values|ANCOVA|||Linagliptin versus Placebo. The primary analysis performed at the interim was re-run at the end of the study to accommodate changes made to the final study database.||-0.32|-0.88|<0.0001
70857939|NCT00740051|141201883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.5|STANDARD_ERROR_OF_MEAN|5.4||0.0002||95.0|-31.1|-9.9||No adjustment of p-values|ANCOVA|||Linagliptin versus Placebo||-9.9|-31.1|0.0002
70857940|NCT00740051|141201884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.576||||0.0374||95.0|1.057|6.279||No adjustment of p-values|Regression, Logistic|||Linagliptin versus Placebo||6.279|1.057|0.0374
70857941|NCT00740051|141201885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.285||||0.1281||95.0|0.71|15.196||No adjustment of p-values|Regression, Logistic|||Linagliptin vs. Placebo||15.196|0.710|0.1281
70857942|NCT00740051|141201886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.801||||0.0046||95.0|1.374|5.711||No adjustment of p-values|Regression, Logistic|||Linagliptin versus Placebo||5.711|1.374|0.0046
70857943|NCT02502006|141201912|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
70857944|NCT02502006|141201913|SUPERIORITY|||||||0.0004|||||||ANOVA|||||||0.0004
70857945|NCT02502006|141201914|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
70857946|NCT02502006|141201915|SUPERIORITY|||||||0.2217|||||||ANOVA|||||||0.2217
70857947|NCT02502006|141201916|SUPERIORITY|||||||0.77||||||Adjusted for multiple comparisons|ANOVA|||||||0.77
70857948|NCT02502006|141201916|SUPERIORITY|||||||0.18||||||Adjusted for multiple comparisons|ANOVA|||||||0.18
70857949|NCT02502006|141201917|SUPERIORITY|||||||0.57||||||Adjusted for multiple comparisons|ANOVA|||||||0.57
70857950|NCT02502006|141201917|SUPERIORITY|||||||0.07||||||Adjusted for multiple comparisons|ANOVA|||||||0.07
70857951|NCT02502006|141201918|SUPERIORITY|||||||0.88||||||Adjusted for multiple comparisons|ANOVA|||||||0.88
70857952|NCT02502006|141201918|SUPERIORITY||||||<|0.05||||||Adjusted for multiple comparisons|ANOVA|||||||<0.05
70857953|NCT00997113|141201939|SUPERIORITY_OR_OTHER|||||||0.94|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of the change in serum catecholamines from one minute before the procedure to one minute after. In order to detect a 20% difference in mean catecholamine values between groups, assuming a 30% standard deviation, with an alpha of 0.05 and a beta of 0.2 (80% power), power analysis indicated that 10 patients per group were required.||||0.940
70857954|NCT02674854|141201961|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|PG324 vs. netarsudil||||||<0.0001
70857955|NCT02674854|141201961|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|PG324 vs. latanoprost||||||<0.0001
70857956|NCT02889562|141201978|OTHER|Pearson chi-squared tests or Fisher exact tests||||||1|||||||Chi-squared|||||||1.0
70857957|NCT02889562|141201981|OTHER|t-test and Wilcoxon analysis||||||0.17|||||||t-test, 1 sided|||||||0.17
70857958|NCT01943474|141201983|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
70857959|NCT01943474|141201984|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
70857960|NCT01943474|141201985|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
70857961|NCT01943474|141201986|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
70857962|NCT01943474|141201987|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
70857963|NCT01943474|141201990|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
70857964|NCT01943474|141201991|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
70857965|NCT02119676|141202001|OTHER||Hazard Ratio (HR)|1.04||||0.588|TWO_SIDED|95.0|0.73|1.49||1-sided|Log Rank|Log-rank test stratified by modified Glasgow Prognostic Score (mGPS) and geographical region.|Estimated using a Cox regression model with Efron's method used for ties, stratified by mGPS score and geographical region|||1.49|0.73|0.588
70857966|NCT02119676|141202001|OTHER||Hazard Ratio (HR)|0.77||||0.136|TWO_SIDED|95.0|0.48|1.23||1-sided|Log Rank|Log rank test stratified by geographical region.|Estimated using Cox regression model with Efron's method used for ties, stratified by geographical region|||1.23|0.48|0.136
70857967|NCT01037088|141202029|SUPERIORITY||||||>|0.05||||||not significant|Mixed Models Analysis|||Hour 1 after Administration of Cannabis||||>.05
70857968|NCT01037088|141202029|SUPERIORITY||||||=|0.0002|||||||Mixed Models Analysis|||Hour 2 after Administration of Cannabis||||=.0002
70857969|NCT01037088|141202029|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Hour 3 after Administration of Cannabis (after the second inhalation of cannabis)||||<.0001
70857970|NCT01037088|141202029|SUPERIORITY||||||=|0.0004|||||||Mixed Models Analysis|||Hour 4 after Administration of Cannabis||||=.0004
70857971|NCT01037088|141202029|SUPERIORITY||||||=|0.0018|||||||Mixed Models Analysis|||Hour 5 after Administration of Cannabis||||=.0018
70857972|NCT02216812|141202030|OTHER|||||||0.63|||||||Regression, Linear|||We tested the null hypothesis that there is no difference in DPC six weeks after fracture of the distal radius between patients taking vitamin C and placebo.||||0.63
70857973|NCT00266864|141202068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4|STANDARD_DEVIATION|2.7|<|0.01|TWO_SIDED|95.0||||One sample t -tests were performed on the percent change from baseline to month 12 \[(month 12- baseline)/baseline\*100\] for comparison to the null hypothesis. An a priori level of significance was set at p ≤ 0.05.|ANOVA|||Separate 2 factor (group: treatment, control) analysis of variance (ANOVA) with repeated measures on visit (baseline, month 12) were performed to identify changes in lean tissue mass across time. To further characterize significant main and interaction effects, post-hoc paired t -tests were performed within group.||||<0.01
71089885|NCT03082729|141686257|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.140
71089886|NCT03082729|141686257|SUPERIORITY|||||||0.633|||||||t-test, 2 sided|||||||0.633
70872033|NCT01652703|141229479|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.69|STANDARD_ERROR_OF_MEAN|2.52|<|0.001|TWO_SIDED|95.0|-65.67|-55.72||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-55.72|-65.67|<0.001
71089887|NCT03082729|141686258|SUPERIORITY|||||||0.302|||||||t-test, 2 sided|||||||0.302
71089888|NCT03082729|141686258|SUPERIORITY|||||||0.405|||||||t-test, 2 sided|||||||0.405
71089889|NCT03082729|141686259|SUPERIORITY|||||||0.297|||||||t-test, 2 sided|||||||0.297
71089890|NCT03082729|141686259|SUPERIORITY|||||||0.324|||||||t-test, 2 sided|||||||0.324
71089891|NCT03082729|141686260|SUPERIORITY|||||||0.812|||||||t-test, 2 sided|||||||0.812
71089892|NCT03082729|141686260|SUPERIORITY|||||||0.264|||||||t-test, 2 sided|||||||0.264
71089893|NCT03082729|141686261|SUPERIORITY|||||||0.283|||||||t-test, 2 sided|||||||0.283
71089894|NCT03082729|141686261|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||0.250
71089895|NCT03082729|141686262|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.170
71089896|NCT03082729|141686262|SUPERIORITY|||||||0.249|||||||t-test, 2 sided|||||||0.249
71089897|NCT03082729|141686263|SUPERIORITY|||||||0.526|||||||t-test, 2 sided|||||||0.526
71089898|NCT03082729|141686263|SUPERIORITY|||||||0.632|||||||t-test, 2 sided|||||||0.632
71089899|NCT03082729|141686264|SUPERIORITY|||||||0.584|||||||t-test, 2 sided|||||||0.584
71089900|NCT03082729|141686264|SUPERIORITY|||||||0.191|||||||t-test, 2 sided|||||||0.191
71089901|NCT03082729|141686265|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||||||0.005
71089902|NCT03082729|141686265|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
71089903|NCT03082729|141686266|SUPERIORITY|||||||0.533|||||||t-test, 2 sided|||||||0.533
71089904|NCT03082729|141686266|SUPERIORITY|||||||0.079|||||||t-test, 2 sided|||||||0.079
71089905|NCT03082729|141686267|SUPERIORITY|||||||0.338|||||||t-test, 2 sided|||||||0.338
71089906|NCT03082729|141686267|SUPERIORITY|||||||0.091|||||||t-test, 2 sided|||||||0.091
71089907|NCT03082729|141686268|SUPERIORITY|||||||0.102|||||||t-test, 2 sided|||||||0.102
71089908|NCT03082729|141686268|SUPERIORITY|||||||0.153|||||||t-test, 2 sided|||||||0.153
71089909|NCT03082729|141686269|SUPERIORITY|||||||0.226|||||||t-test, 2 sided|||||||0.226
71089910|NCT03082729|141686269|SUPERIORITY|||||||0.222|||||||t-test, 2 sided|||||||0.222
71089911|NCT03082729|141686270|SUPERIORITY|||||||0.384|||||||t-test, 2 sided|||||||0.384
71089912|NCT03082729|141686270|SUPERIORITY|||||||0.112|||||||t-test, 2 sided|||||||0.112
71089913|NCT03082729|141686271|SUPERIORITY|||||||0.636|||||||t-test, 2 sided|||||||0.636
71089914|NCT03082729|141686271|SUPERIORITY|||||||0.896|||||||t-test, 2 sided|||||||0.896
71089915|NCT03082729|141686272|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.800
71089916|NCT03082729|141686272|SUPERIORITY|||||||0.551|||||||t-test, 2 sided|||||||0.551
71089917|NCT03082729|141686273|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||||||0.440
71089918|NCT03082729|141686273|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.170
71089919|NCT03082729|141686274|SUPERIORITY|||||||0.278|||||||t-test, 2 sided|||||||0.278
71089920|NCT03082729|141686274|SUPERIORITY|||||||0.089|||||||t-test, 2 sided|||||||0.089
71089921|NCT03082729|141686275|SUPERIORITY|||||||0.795|||||||t-test, 2 sided|||||||0.795
71089922|NCT03082729|141686275|SUPERIORITY|||||||0.284|||||||t-test, 2 sided|||||||0.284
71089923|NCT03082729|141686276|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||||||0.880
71089924|NCT03082729|141686276|SUPERIORITY|||||||0.028|||||||t-test, 2 sided|||||||0.028
71089925|NCT03082729|141686277|SUPERIORITY|||||||0.746|||||||t-test, 2 sided|||||||0.746
71089926|NCT03082729|141686277|SUPERIORITY|||||||0.199|||||||t-test, 2 sided|||||||0.199
71089927|NCT03082729|141686278|SUPERIORITY|||||||0.814|||||||t-test, 2 sided|||||||0.814
71089928|NCT03082729|141686278|SUPERIORITY|||||||0.036|||||||t-test, 2 sided|||||||0.036
71089929|NCT03082729|141686279|SUPERIORITY|||||||0.494|||||||t-test, 2 sided|||||||0.494
71089930|NCT03082729|141686279|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.960
71089931|NCT03082729|141686280|SUPERIORITY|||||||0.777|||||||t-test, 2 sided|||||||0.777
71089932|NCT03082729|141686280|SUPERIORITY|||||||0.028|||||||t-test, 2 sided|||||||0.028
71089933|NCT03082729|141686281|SUPERIORITY|||||||0.241|||||||t-test, 2 sided|||||||0.241
70872034|NCT01652703|141229479|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-46.75|STANDARD_ERROR_OF_MEAN|2.56|<|0.001|TWO_SIDED|95.0|-51.8|-41.7||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-41.70|-51.80|<0.001
71089934|NCT03082729|141686281|SUPERIORITY|||||||0.869|||||||t-test, 2 sided|||||||0.869
71089935|NCT03082729|141686282|SUPERIORITY|||||||0.977|||||||t-test, 2 sided|||||||0.977
71089936|NCT03082729|141686282|SUPERIORITY|||||||0.012|||||||t-test, 2 sided|||||||0.012
71089937|NCT03082729|141686283|SUPERIORITY|||||||0.591|||||||t-test, 2 sided|||||||0.591
71089938|NCT03082729|141686283|SUPERIORITY|||||||0.088|||||||t-test, 2 sided|||||||0.088
71089939|NCT03082729|141686284|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|||||||0.260
71089940|NCT03082729|141686284|SUPERIORITY|||||||0.526|||||||t-test, 2 sided|||||||0.526
71089941|NCT03082729|141686285|SUPERIORITY|||||||0.545|||||||t-test, 2 sided|||||||0.545
71089942|NCT03082729|141686285|SUPERIORITY|||||||0.69|||||||t-test, 2 sided|||||||0.690
71089943|NCT03082729|141686286|SUPERIORITY|||||||0.542|||||||t-test, 2 sided|||||||0.542
71089944|NCT03082729|141686286|SUPERIORITY|||||||0.344|||||||t-test, 2 sided|||||||0.344
71089945|NCT03082729|141686287|SUPERIORITY|||||||0.918|||||||t-test, 2 sided|||||||0.918
71089946|NCT03082729|141686287|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||0.035
71089947|NCT03082729|141686288|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.510
71089948|NCT03082729|141686288|SUPERIORITY|||||||0.516|||||||t-test, 2 sided|||||||0.516
71089949|NCT03082729|141686289|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||||||0.046
71089950|NCT03082729|141686289|SUPERIORITY|||||||0.088|||||||t-test, 2 sided|||||||0.088
71089951|NCT03082729|141686290|SUPERIORITY|||||||0.392|||||||t-test, 2 sided|||||||0.392
71089952|NCT03082729|141686290|SUPERIORITY|||||||0.177|||||||t-test, 2 sided|||||||0.177
71089953|NCT03082729|141686291|SUPERIORITY|||||||0.584|||||||t-test, 2 sided|||||||0.584
71089954|NCT03082729|141686291|SUPERIORITY|||||||0.065|||||||t-test, 2 sided|||||||0.065
71089955|NCT03082729|141686292|SUPERIORITY|||||||0.421|||||||t-test, 2 sided|||||||0.421
71089956|NCT03082729|141686292|SUPERIORITY|||||||0.145|||||||t-test, 2 sided|||||||0.145
71089957|NCT03082729|141686293|SUPERIORITY|||||||0.611|||||||t-test, 2 sided|||||||0.611
71089958|NCT03082729|141686293|SUPERIORITY|||||||0.345|||||||t-test, 2 sided|||||||0.345
71089959|NCT03082729|141686294|SUPERIORITY|||||||0.957|||||||t-test, 2 sided|||||||0.957
71089960|NCT03082729|141686294|SUPERIORITY|||||||0.425|||||||t-test, 2 sided|||||||0.425
71089961|NCT03082729|141686295|SUPERIORITY|||||||0.698|||||||t-test, 2 sided|||||||0.698
71089962|NCT03082729|141686295|SUPERIORITY|||||||0.709|||||||t-test, 2 sided|||||||0.709
71089963|NCT03082729|141686296|SUPERIORITY|||||||0.362|||||||t-test, 2 sided|||||||0.362
70857974|NCT00266864|141202069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|101.0|STANDARD_DEVIATION|103.0||0.051|TWO_SIDED|95.0||||One sample t -tests were performed on the percent change from baseline to month 12 \[(month 12- baseline)/baseline\*100\] for comparison to the null hypothesis. An a priori level of significance was set at p ≤ 0.05.|ANOVA|||Separate 2 factor (group: treatment, control) analysis of variance (ANOVA) with repeated measures on visit (baseline, month 12) were performed to identify changes in resting energy expenditure across time. To further characterize significant main and interaction effects, post-hoc paired t -tests were performed within group.||||0.051
70857975|NCT03036800|141202070|SUPERIORITY||Odds Ratio (OR)|5.19|||<|0.001|TWO_SIDED|95.0|2.09|12.88|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||12.88|2.09|<0.001
70857976|NCT03036800|141202071|SUPERIORITY||Odds Ratio (OR)|5.94|||<|0.001|TWO_SIDED|95.0|2.45|14.4|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||14.4|2.45|<0.001
70857977|NCT03036800|141202072|SUPERIORITY||Odds Ratio (OR)|5.04||||0.002|TWO_SIDED|95.0|1.81|14.01|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||14.01|1.81|0.002
70857978|NCT03036800|141202073|SUPERIORITY||Odds Ratio (OR)|5.24||||0.002|TWO_SIDED|95.0|1.88|14.64|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||14.64|1.88|0.002
70857979|NCT03036800|141202090|SUPERIORITY||Odds Ratio (OR)|10.12|||<|0.001|TWO_SIDED|95.0|5.26|19.48|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥5% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||19.48|5.26|<0.001
70857980|NCT03036800|141202091|SUPERIORITY||Odds Ratio (OR)|5.17|||<|0.001|TWO_SIDED|95.0|2.86|9.36|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥5% from baseline at 32 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||9.36|2.86|<0.001
70857981|NCT03036800|141202092|SUPERIORITY||Odds Ratio (OR)|4.16|||<|0.001|TWO_SIDED|95.0|2.39|7.22|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥5% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||7.22|2.39|<0.001
70857982|NCT03036800|141202093|SUPERIORITY||Odds Ratio (OR)|2.44||||0.01|TWO_SIDED|95.0|1.23|4.84|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥5% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||4.84|1.23|0.010
70857983|NCT03036800|141202094|SUPERIORITY||Odds Ratio (OR)|5.14|||<|0.001|TWO_SIDED|95.0|2.14|12.39|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||12.39|2.14|<0.001
70946440|NCT00846768|141393216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.052|STANDARD_ERROR_OF_MEAN|0.015||0.0006||95.0|-0.081|-0.023|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||-0.023|-0.081|0.0006
70857984|NCT03036800|141202095|SUPERIORITY||Odds Ratio (OR)|6.53|||<|0.001|TWO_SIDED|95.0|3.32|12.86|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 32 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||12.86|3.32|<0.001
70857985|NCT03036800|141202096|SUPERIORITY||Odds Ratio (OR)|8.08|||<|0.001|TWO_SIDED|95.0|3.8|17.16|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||17.16|3.80|<0.001
70857986|NCT03036800|141202097|SUPERIORITY||Odds Ratio (OR)|2.28||||0.065|TWO_SIDED|95.0|0.95|5.47|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||5.47|0.95|0.065
70857987|NCT03036800|141202098|SUPERIORITY||Odds Ratio (OR)|2.84||||0.206|TWO_SIDED|95.0|0.56|14.34|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||14.34|0.56|0.206
70857988|NCT03036800|141202099|SUPERIORITY||Odds Ratio (OR)|3.23||||0.023|TWO_SIDED|95.0|1.17|8.9|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥32% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||8.90|1.17|0.023
70857989|NCT03036800|141202100|SUPERIORITY||Odds Ratio (OR)|4.11||||0.07|TWO_SIDED|95.0|0.89|18.93|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||18.93|0.89|0.070
71089964|NCT03082729|141686296|SUPERIORITY|||||||0.221|||||||t-test, 2 sided|||||||0.221
71126967|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.3365|TWO_SIDED|95.0|0.79|1.167|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.167|0.790|0.3365
71126968|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.95||||0.3339|TWO_SIDED|95.0|0.77|1.163|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 18 hours||1.163|0.770|0.3339
71126969|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.3608|TWO_SIDED|95.0|0.786|1.166|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.166|0.786|0.3608
71126970|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.3584|TWO_SIDED|95.0|0.788|1.168|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24.5 hours||1.168|0.788|0.3584
71126971|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.88||||0.1219|TWO_SIDED|95.0|0.725|1.073|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 25 hours||1.073|0.725|0.1219
71126972|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4662|TWO_SIDED|95.0|0.814|1.21|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 26 hours||1.210|0.814|0.4662
71126973|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.02||||0.5748|TWO_SIDED|95.0|0.828|1.247|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 28 hours||1.247|0.828|0.5748
71126974|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.97||||0.4104|TWO_SIDED|95.0|0.786|1.204|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 30 hours||1.204|0.786|0.4104
71126975|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.5114|TWO_SIDED|95.0|0.817|1.246|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 32 hours||1.246|0.817|0.5114
71126976|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.4213|TWO_SIDED|95.0|0.783|1.2|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 36 hours||1.200|0.783|0.4213
71126977|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.93||||0.2663|TWO_SIDED|95.0|0.731|1.132|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 42 hours||1.132|0.731|0.2663
71126978|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.2373|TWO_SIDED|95.0|0.72|1.142|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.142|0.720|0.2373
71126979|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.2575|TWO_SIDED|95.0|0.721|1.149|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||1.149|0.721|0.2575
71126980|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.2173|TWO_SIDED|95.0|0.708|1.127|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 49 hours||1.127|0.708|0.2173
71126981|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.2406|TWO_SIDED|95.0|0.717|1.143|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||1.143|0.717|0.2406
71126982|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.2471|TWO_SIDED|95.0|0.721|1.151|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 52 hours||1.151|0.721|0.2471
71126983|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.93||||0.2585|TWO_SIDED|95.0|0.727|1.157|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||1.157|0.727|0.2585
71126984|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.94||||0.3101|TWO_SIDED|95.0|0.737|1.17|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 56 hours||1.170|0.737|0.3101
71126985|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.2476|TWO_SIDED|95.0|0.727|1.16|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||1.160|0.727|0.2476
71126986|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.3887|TWO_SIDED|95.0|0.767|1.222|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||1.222|0.767|0.3887
71126987|NCT01597635|141760171|SUPERIORITY||Ratio of Active/Placebo|0.92||||0.2294|TWO_SIDED|95.0|0.749|1.146|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.146|0.749|0.2294
71126988|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.09||||0.8522|TWO_SIDED|95.0|0.916|1.234|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 168 hours||1.234|0.916|0.8522
71126989|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.02||||0.5885|TWO_SIDED|95.0|0.89|1.164|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||1.164|0.890|0.5885
71126990|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.07||||0.8558|TWO_SIDED|95.0|0.94|1.23|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 1 hour||1.230|0.940|0.8558
71126991|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.07||||0.8374|TWO_SIDED|95.0|0.932|1.224|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hour||1.224|0.932|0.8374
71126992|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.01||||0.5886|TWO_SIDED|95.0|0.887|1.152|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 4 hours||1.152|0.887|0.5886
71126993|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.7532|TWO_SIDED|95.0|0.918|1.18|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||1.180|0.918|0.7532
71126994|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.04||||0.7108|TWO_SIDED|95.0|0.906|1.179|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 8 hours||1.179|0.906|0.7108
71126995|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.04||||0.7445|TWO_SIDED|95.0|0.918|1.19|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.190|0.918|0.7445
71126996|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.3759|TWO_SIDED|95.0|0.863|1.115|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 18 hours||1.115|0.863|0.3759
71126997|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.398|TWO_SIDED|95.0|0.859|1.118|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.118|0.859|0.3980
71126998|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.97||||0.3231|TWO_SIDED|95.0|0.849|1.103|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24.5 hours||1.103|0.849|0.3231
71126999|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.93||||0.1245|TWO_SIDED|95.0|0.812|1.056|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 25 hours||1.056|0.812|0.1245
71127000|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4631|TWO_SIDED|95.0|0.87|1.134|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 26 hours||1.134|0.870|0.4631
71127001|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.1026|TWO_SIDED|95.0|0.801|1.047|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 28 hours||1.047|0.801|0.1026
71127002|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.97||||0.3152|TWO_SIDED|95.0|0.85|1.101|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 30 hours||1.101|0.850|0.3152
71127003|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.0762|TWO_SIDED|95.0|0.803|1.035|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 32 hours||1.035|0.803|0.0762
71127004|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.88||||0.0274||95.0|0.763|1.003|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 36 hours||1.003|0.763|0.0274
70857990|NCT03036800|141202101|SUPERIORITY||Odds Ratio (OR)|0.59||||0.601|TWO_SIDED|95.0|0.08|4.24|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||4.24|0.08|0.601
70857991|NCT03036800|141202102|SUPERIORITY||Mean Difference (Net)|-4.63|||<|0.001|TWO_SIDED|95.0|-5.85|-3.4|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute weight change (kg) from baseline at 16 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-3.4|-5.85|<0.001
70857992|NCT03036800|141202103|SUPERIORITY||Mean Difference (Net)|-5.89|||<|0.001|TWO_SIDED|95.0|-7.76|-4.02|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute weight change (kg) from baseline at 32 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-4.02|-7.76|<0.001
70857993|NCT03036800|141202104|SUPERIORITY||Mean Difference (Net)|-6.87|||<|0.001|TWO_SIDED|95.0|-9.03|-4.71|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute weight change (kg) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-4.71|-9.03|<0.001
70857994|NCT03036800|141202105|SUPERIORITY||Mean Difference (Net)|-5.44|||<|0.001|TWO_SIDED|95.0|-8.34|-2.53|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute weight change (kg) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-2.53|-8.34|<0.001
70857995|NCT03036800|141202106|SUPERIORITY||Mean Difference (Net)|-3.72|||<|0.001|TWO_SIDED|95.0|-4.63|-2.8|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 16 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-2.80|-4.63|<0.001
71089965|NCT03082729|141686297|SUPERIORITY|||||||0.813|||||||t-test, 2 sided|||||||0.813
70857996|NCT03036800|141202107|SUPERIORITY||Mean Difference (Net)|-4.7|||<|0.001|TWO_SIDED|95.0|-6.14|-3.25|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 32 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-3.25|-6.14|<0.001
70857997|NCT03036800|141202108|SUPERIORITY||Mean Difference (Net)|-5.37|||<|0.001|TWO_SIDED|95.0|-7.02|-3.71|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-3.71|-7.02|<0.001
70857998|NCT03036800|141202109|SUPERIORITY||Mean Difference (Net)|-4.1||||0.001|TWO_SIDED|95.0|-6.42|-1.77|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-1.77|-6.42|0.001
70857999|NCT03036800|141202110|SUPERIORITY||Mean Difference (Net)|-2.7|||<|0.001|TWO_SIDED|95.0|-3.5|-1.91|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute BMI change (kg/m2) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-1.91|-3.5|<0.001
70872035|NCT01652703|141229479|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-53.44|STANDARD_ERROR_OF_MEAN|2.77|<|0.001|TWO_SIDED|95.0|-58.91|-47.97||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-47.97|-58.91|<0.001
71089966|NCT03082729|141686297|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||||||0.046
71089967|NCT03082729|141686298|SUPERIORITY|||||||0.752|||||||t-test, 2 sided|||||||0.752
71127005|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.3594|TWO_SIDED|95.0|0.853|1.112|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 42 hours||1.112|0.853|0.3594
71127006|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.04||||0.7027|TWO_SIDED|95.0|0.906|1.197|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.197|0.906|0.7027
71127007|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.08||||0.8661|TWO_SIDED|95.0|0.941|1.246|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||1.246|0.941|0.8661
71127008|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.06||||0.8084|TWO_SIDED|95.0|0.924|1.228|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 49 hours||1.228|0.924|0.8084
71127009|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.13||||0.9504|TWO_SIDED|95.0|0.976|1.3|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||1.300|0.976|0.9504
71127010|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.01||||0.53|TWO_SIDED|95.0|0.871|1.164|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 52 hours||1.164|0.871|0.5300
71127011|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.08||||0.8595|TWO_SIDED|95.0|0.942|1.243|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||1.243|0.942|0.8595
71089968|NCT03082729|141686298|SUPERIORITY|||||||0.808|||||||t-test, 2 sided|||||||0.808
71127012|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.09||||0.8802|TWO_SIDED|95.0|0.943|1.261|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 56 hours||1.261|0.943|0.8802
71127013|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.11||||0.9232|TWO_SIDED|95.0|0.958|1.278|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||1.278|0.958|0.9232
71127014|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.07||||0.7911|TWO_SIDED|95.0|0.902|1.256|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||1.256|0.902|0.7911
71127015|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.28||||0.9946|TWO_SIDED|95.0|1.059|1.514|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.514|1.059|0.9946
71089969|NCT03082729|141686299|SUPERIORITY|||||||0.251|||||||t-test, 2 sided|||||||0.251
71127016|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.26||||0.983|TWO_SIDED|95.0|1.019|1.444|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 168 hours||1.444|1.019|0.9830
71089970|NCT03082729|141686299|SUPERIORITY|||||||0.329|||||||t-test, 2 sided|||||||0.329
71089971|NCT03082729|141686300|SUPERIORITY|||||||0.215|||||||t-test, 2 sided|||||||0.215
71089972|NCT03082729|141686300|SUPERIORITY|||||||0.612|||||||t-test, 2 sided|||||||0.612
71089973|NCT03082729|141686301|SUPERIORITY|||||||0.307|||||||t-test, 2 sided|||||||0.307
71089974|NCT03082729|141686301|SUPERIORITY|||||||0.686|||||||t-test, 2 sided|||||||0.686
71089975|NCT03082729|141686302|SUPERIORITY|||||||0.139|||||||t-test, 2 sided|||||||0.139
71089976|NCT03082729|141686302|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||0.350
71089977|NCT03082729|141686303|SUPERIORITY|||||||0.721|||||||t-test, 2 sided|||||||0.721
71089978|NCT03082729|141686303|SUPERIORITY|||||||0.285|||||||t-test, 2 sided|||||||0.285
71089979|NCT03082729|141686304|SUPERIORITY|||||||0.804|||||||t-test, 2 sided|||||||0.804
71089980|NCT03082729|141686304|SUPERIORITY|||||||0.793|||||||t-test, 2 sided|||||||0.793
71089981|NCT03082729|141686305|SUPERIORITY|||||||0.293|||||||t-test, 2 sided|||||||0.293
71089982|NCT03082729|141686305|SUPERIORITY|||||||0.355|||||||t-test, 2 sided|||||||0.355
71089983|NCT03082729|141686306|SUPERIORITY|||||||0.101|||||||t-test, 2 sided|||||||0.101
71089984|NCT03082729|141686306|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.170
71089985|NCT03082729|141686307|SUPERIORITY|||||||0.137|||||||t-test, 2 sided|||||||0.137
71089986|NCT03082729|141686307|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||||||0.204
71089987|NCT03082729|141686308|SUPERIORITY|||||||0.115|||||||t-test, 2 sided|||||||0.115
71089988|NCT03082729|141686308|SUPERIORITY|||||||0.378|||||||t-test, 2 sided|||||||0.378
71089989|NCT03082729|141686309|SUPERIORITY|||||||0.122|||||||t-test, 2 sided|||||||0.122
71089990|NCT03082729|141686309|SUPERIORITY|||||||0.815|||||||t-test, 2 sided|||||||0.815
71089991|NCT03082729|141686310|SUPERIORITY|||||||0.321|||||||t-test, 2 sided|||||||0.321
71089992|NCT03082729|141686310|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||||||0.204
71089993|NCT03082729|141686311|SUPERIORITY|||||||0.352|||||||t-test, 2 sided|||||||0.352
71089994|NCT03082729|141686311|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||||||0.180
71089995|NCT03082729|141686312|SUPERIORITY|||||||0.094|||||||t-test, 2 sided|||||||0.094
71089996|NCT03082729|141686312|SUPERIORITY|||||||0.383|||||||t-test, 2 sided|||||||0.383
71089997|NCT03082729|141686313|SUPERIORITY|||||||0.024|||||||t-test, 2 sided|||||||0.024
71089998|NCT03082729|141686313|SUPERIORITY|||||||0.266|||||||t-test, 2 sided|||||||0.266
71089999|NCT03082729|141686314|SUPERIORITY|||||||0.042|||||||t-test, 2 sided|||||||0.042
71090000|NCT03082729|141686314|SUPERIORITY|||||||0.208|||||||t-test, 2 sided|||||||0.208
71090001|NCT03082729|141686315|SUPERIORITY|||||||0.446|||||||t-test, 2 sided|||||||0.446
71090002|NCT03082729|141686315|SUPERIORITY|||||||0.611|||||||t-test, 2 sided|||||||0.611
71090003|NCT03082729|141686316|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
71090004|NCT03082729|141686316|SUPERIORITY|||||||0.405|||||||t-test, 2 sided|||||||0.405
71090005|NCT00434252|141686339|SUPERIORITY_OR_OTHER||Difference in survival rates|3.5||||0.5724||95.0|-8.7|15.7|||z-test|z-test using the standard errors computed using Greenwood's method.||||15.7|-8.7|0.5724
71090006|NCT00434252|141686340|SUPERIORITY_OR_OTHER||Difference in event rates|12.2||||0.0982||95.0|-2.3|26.6|||z-test|z-test using the standard errors computed using Greenwood's method||||26.6|-2.3|0.0982
71127017|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.08||||0.8024|TWO_SIDED|95.0|0.91|1.261|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||1.261|0.910|0.8024
71127018|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.4806|TWO_SIDED|95.0|0.843|1.166|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 1 hour||1.166|0.843|0.4806
71127019|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.04||||0.6658|TWO_SIDED|95.0|0.869|1.223|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||1.223|0.869|0.6658
71127020|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.03||||0.6131|TWO_SIDED|95.0|0.856|1.212|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 4 hours||1.212|0.856|0.6131
71127021|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.02||||0.5795|TWO_SIDED|95.0|0.856|1.197|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||1.197|0.856|0.5795
71127022|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.85||||0.0209|TWO_SIDED|95.0|0.716|0.993|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 8 hours||0.993|0.716|0.0209
71127023|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.4823|TWO_SIDED|95.0|0.83|1.187|||Mixed Models Analysis|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.187|0.830|0.4823
71127024|NCT01597635|141760171|SUPERIORITY_OR_OTHER||0.0406|0.85||||0.0406|TWO_SIDED|95.0|0.703|1.021|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 18 hours||1.021|0.703|0.0406
71127025|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.5186|TWO_SIDED|95.0|0.844|1.169|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.169|0.844|0.5186
71127026|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.387|TWO_SIDED|95.0|0.824|1.132|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24.5 hours||1.132|0.824|0.3870
71127027|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.1281|TWO_SIDED|95.0|0.77|1.065|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 25 hours||1.065|0.770|0.1281
71127028|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4754|TWO_SIDED|95.0|0.837|1.181|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 26 hours||1.181|0.837|0.4754
71127029|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.01||||0.5627|TWO_SIDED|95.0|0.856|1.217|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 28 hours||1.217|0.856|0.5627
71127030|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.01||||0.5552|TWO_SIDED|95.0|0.848|1.22|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 30 hours||1.220|0.848|0.5552
71127031|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.503|TWO_SIDED|95.0|0.843|1.201|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 32 hours||1.201|0.843|0.5030
71127032|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.01||||0.5558|TWO_SIDED|95.0|0.84|1.218|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 36 hours||1.218|0.840|0.5558
71127033|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.94||||0.2709|TWO_SIDED|95.0|0.769|1.135|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 42 hours||1.135|0.769|0.2709
71127034|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.4143|TWO_SIDED|95.0|0.795|1.208|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.208|0.795|0.4143
71127035|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.09||||0.7886|TWO_SIDED|95.0|0.891|1.348|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||1.348|0.891|0.7886
71127036|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.08||||0.7607|TWO_SIDED|95.0|0.885|1.353|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 49 hours||1.353|0.885|0.7607
71127037|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.13||||0.8677|TWO_SIDED|95.0|0.922|1.4|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||1.400|0.922|0.8677
71090007|NCT02807259|141686342|EQUIVALENCE|Power calculations did not account for stratification used in the randomisation or include adjustment for baseline levels of the outcome, since the correlation over time was not known. Results suggested that the trial had \>80% power to detect a risk ratio of 0.77, if the coefficient of between-cluster variation was between 0.15 and 0.25.|Odds Ratio (OR)|1.47||||0.298|TWO_SIDED|95.0|0.71|3.01|||Mixed Models Analysis|||Power calculations were conducted assuming an IPV prevalence (past 12 months) of 47% and consistent condom use (past 12 months) of 38% based on initial assessments. The power calculation was performed by analysing simulated data from 800 women, distributed across clusters using empirical data with a range in variance across cluster-level proportions of IPV (15% to 25% of the total variation) and a narrow range of effect sizes (risk ratio= 0.75-0.80).||3.01|0.71|0.298
71090008|NCT02807259|141686343|OTHER||Odds Ratio (OR)|1.38||||0.378|TWO_SIDED|95.0|0.68|2.81|||Mixed Models Analysis|||||2.81|0.68|0.378
71090009|NCT02807259|141686344|OTHER||Odds Ratio (OR)|0.93||||0.748|TWO_SIDED|95.0|0.58|1.47|||Mixed Models Analysis|||||1.47|0.58|0.748
71090010|NCT02807259|141686345|OTHER||Odds Ratio (OR)|0.62||||0.025|TWO_SIDED|95.0|0.4|0.94|||Mixed Models Analysis|||||0.94|0.4|0.025
71090011|NCT02807259|141686346|OTHER||Odds Ratio (OR)|2.07||||0.372|TWO_SIDED|95.0|0.42|10.26|||Mixed Models Analysis|||||10.26|0.42|0.372
71090012|NCT02807259|141686347|OTHER||Odds Ratio (OR)|0.96||||0.845|TWO_SIDED|95.0|0.61|1.5|||Mixed Models Analysis|||||1.50|0.61|0.845
71090013|NCT02807259|141686348|OTHER||Odds Ratio (OR)|1.69||||0.042|TWO_SIDED|95.0|1.02|2.82|||Mixed Models Analysis|||||2.82|1.02|0.042
71090014|NCT01898078|141686429|SUPERIORITY_OR_OTHER||Least Squares Mean Ratio|0.97|||||TWO_SIDED|90.0|0.85|1.12|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the treatment effect, sequence effect, period effect and random terms for participants within sequence.|The confidence intervals are calculated for the difference in the LS means of the ln-transformed Cmax plain values (difference = Fed/Fasted). Antilogs of the confidence limits for the difference are taken to construct the confidence intervals for the ratio of the geometric means.||1.12|0.85|
70946441|NCT00846768|141393216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.047|STANDARD_ERROR_OF_MEAN|0.015||0.0019||95.0|-0.076|-0.017|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||-0.017|-0.076|0.0019
71090015|NCT01898078|141686430|SUPERIORITY_OR_OTHER||Least Square Mean Ratio|1.16|||||TWO_SIDED|90.0|1.01|1.34|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the treatment effect, sequence effect, period effect and random terms for participants within sequence.|The confidence intervals are calculated for the difference in the LS means of the ln-transformed AUC(last) plain values (difference = Fed/Fasted). Antilogs of the confidence limits for the difference are taken to construct the confidence intervals for the ratio of the geometric mean.||1.34|1.01|
71090016|NCT01898078|141686431|SUPERIORITY_OR_OTHER||Least Square Mean Ratio|1.15|||||TWO_SIDED|90.0|0.96|1.39|||||Estimates for each PK parameter were obtained using a mixed effects model of log(PK parameter) with fixed terms for the treatment effect, sequence effect, period effect and random terms for participants within sequence.|The confidence intervals are calculated for the difference in the LS means of the ln-transformed AUC∞ plain values (difference = Fed/Fasted). Antilogs of the confidence limits for the difference are taken to construct the confidence intervals for the ratio of the geometric mean||1.39|0.96|
71090017|NCT01140906|141686435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.53|STANDARD_ERROR_OF_MEAN|1.09|<|0.0001|TWO_SIDED|95.0|-7.66|-3.4||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-3.40|-7.66|<0.0001
71090018|NCT01140906|141686435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.09|STANDARD_ERROR_OF_MEAN|1.08|<|0.0001|TWO_SIDED|95.0|-9.21|-4.97||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-4.97|-9.21|<0.0001
71090019|NCT01140906|141686435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.45|STANDARD_ERROR_OF_MEAN|1.07|<|0.0001|TWO_SIDED|95.0|-11.55|-7.35||This treatment arm was not in the testing sequence. A nominal p-value is provided.|MMRM|||||-7.35|-11.55|<0.0001
71127038|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.06||||0.7012|TWO_SIDED|95.0|0.847|1.302|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 52 hours||1.302|0.847|0.7012
71127039|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.5156|TWO_SIDED|95.0|0.805|1.23|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||1.230|0.805|0.5156
71127040|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.3524|TWO_SIDED|95.0|0.783|1.178|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 56 hours||1.178|0.783|0.3524
71127041|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.04||||0.638|TWO_SIDED|95.0|0.845|1.292|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||1.292|0.845|0.6380
70872036|NCT01652703|141229479|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-47.37|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-52.9|-41.85||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-41.85|-52.90|<0.001
71090020|NCT01140906|141686436|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.8|||<|0.0001|TWO_SIDED|95.0|1.76|4.47||Wald's test. Since p-value \<0.025, hierarchically testing continued.|Adjusted Odds Ratio||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||4.47|1.76|<0.0001
71090021|NCT01140906|141686436|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.36|||<|0.0001|TWO_SIDED|95.0|2.1|5.36||Wald's test. Since p-value \<0.025, hierarchically testing continued.|Adjusted Odds Ratio||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||5.36|2.10|<0.0001
70858000|NCT03036800|141202111|SUPERIORITY||Mean Difference (Net)|-1.89|||<|0.001|TWO_SIDED|95.0|-2.91|-0.86|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute BMI change (kg/m2) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-0.86|-2.91|<0.001
71090022|NCT01140906|141686436|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.94|||<|0.0001|TWO_SIDED|95.0|3.61|9.78||This treatment arm was not in the testing sequence. A nominal p-value is provided.|Adjusted Odds Ratio|||||9.78|3.61|<0.0001
71090023|NCT01140906|141686437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.94|-0.44||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-0.44|-0.94|<0.0001
71090024|NCT01140906|141686437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-0.70|-1.20|<0.0001
71090025|NCT01140906|141686437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.36|-0.87||This treatment arm was not in the testing sequence. A nominal p-value is provided.|MMRM|||||-0.87|-1.36|<0.0001
71090026|NCT01140906|141686438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.24|STANDARD_ERROR_OF_MEAN|1.53||0.0007|TWO_SIDED|95.0|-8.25|-2.22||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-2.22|-8.25|0.0007
71090027|NCT01140906|141686438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.42|STANDARD_ERROR_OF_MEAN|1.58|<|0.0001|TWO_SIDED|95.0|-9.53|-3.31||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-3.31|-9.53|<0.0001
71090028|NCT01140906|141686438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.71|STANDARD_ERROR_OF_MEAN|1.54|<|0.0001|TWO_SIDED|95.0|-11.73|-5.69||This treatment arm was not in the testing sequence. A nominal p-value is provided.|MMRM|||||-5.69|-11.73|<0.0001
71090029|NCT01140906|141686439|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.32||||0.0016|TWO_SIDED|95.0|1.37|3.91||Wald's test. Since p-value \<0.025, hierarchically testing continued.|Adjusted Odds Ratio||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||3.91|1.37|0.0016
71090030|NCT01140906|141686439|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.65||||0.0002|TWO_SIDED|95.0|1.58|4.44||Wald's test. Since p-value \<0.025, hierarchically testing continued.|Adjusted Odds Ratio||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||4.44|1.58|0.0002
71090031|NCT01140906|141686439|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.01|||<|0.0001|TWO_SIDED|95.0|2.99|8.37||Wald's test. This treatment arm was not in the testing sequence. A nominal p-value is provided.|Adjusted for Odds Ratio|||||8.37|2.99|<0.0001
71090032|NCT01140906|141686440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.24|STANDARD_ERROR_OF_MEAN|1.16||0.0054|TWO_SIDED|95.0|-5.51|-0.97||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-0.97|-5.51|0.0054
71127042|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.4003|TWO_SIDED|95.0|0.743|1.241|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||1.241|0.743|0.4003
71127043|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.16||||0.8817|TWO_SIDED|95.0|0.907|1.502|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.502|0.907|0.8817
71127044|NCT01597635|141760171|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.14||||0.8145|TWO_SIDED|95.0|0.804|1.505|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 168 hours||1.505|0.804|0.8145
71127045|NCT01597635|141760172|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.6468|TWO_SIDED|95.0|0.765|1.321|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||1.321|0.765|0.6468
71127046|NCT01597635|141760172|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.1965|TWO_SIDED|95.0|0.658|1.136|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 1 hour||1.136|0.658|0.1965
70946442|NCT00846768|141393216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012|STANDARD_ERROR_OF_MEAN|0.015||0.4111||95.0|-0.041|0.017|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.017|-0.041|0.4111
70858001|NCT03036800|141202112|SUPERIORITY||Mean Difference (Net)|-3.28||||0.01|TWO_SIDED|95.0|-5.77|-0.8|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute waist circumference change (cm) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-0.80|-5.77|0.01
70872037|NCT01652703|141229480|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-34.49|STANDARD_ERROR_OF_MEAN|11.75||0.004|TWO_SIDED|95.0|-57.71|-11.26||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-11.26|-57.71|0.004
70946443|NCT00846768|141393216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.015||0.709||95.0|-0.035|0.024|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.024|-0.035|0.7090
71090033|NCT01140906|141686440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.92|STANDARD_ERROR_OF_MEAN|1.11||0.0005|TWO_SIDED|95.0|-6.11|-1.73||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-1.73|-6.11|0.0005
71090034|NCT01140906|141686440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.93|STANDARD_ERROR_OF_MEAN|1.13|<|0.0001|TWO_SIDED|95.0|-9.16|-4.7||This treatment arm was not in the testing sequence. A nominal p-value is provided.|MMRM|||||-4.70|-9.16|<0.0001
71090035|NCT01140906|141686441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.59||0.2524|TWO_SIDED|95.0|-1.83|0.48||A nominal p-value is provided.|MMRM||No correction for multiplicity was made.|||0.48|-1.83|0.2524
71090036|NCT01140906|141686441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.59||0.4186|TWO_SIDED|95.0|-1.64|0.68||A nominal p-value is provided.|MMRM||No correction for multiplicity was made.|||0.68|-1.64|0.4186
71090037|NCT01140906|141686442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.41||0.7372|TWO_SIDED|95.0|-0.95|0.67||A nominal p-value is provided.|ANCOVA|||||0.67|-0.95|0.7372
71090038|NCT01140906|141686442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|STANDARD_ERROR_OF_MEAN|0.41||0.169|TWO_SIDED|95.0|-0.24|1.37||A nominal p-value is provided.|ANCOVA|||||1.37|-0.24|0.1690
71090039|NCT03720119|141686460|OTHER|Analysis of Variance for repeated measurements.|day effect F|27.83||||0.0001|TWO_SIDED|||||The calculated P-Value represents the repeated measurement/Day (all times versus Day 1)|Dunnett's post-hoc test|||||||0.0001
71090040|NCT03743194|141686462|SUPERIORITY||Geometric mean ratio|0.98||||0.75|TWO_SIDED|95.0|0.85|1.13|||Linear mixed model|||A mixed effects linear model with repeated measures assuming an auto-regressive correlation structure was used to estimate the ratio of geometric means (treatment vs control). One patient from the control group whose measurements were all missing was conservatively imputed to have total OBAS of 2, 1, and 0 at postoperative Days 1, 2, and 3, respectively, assuming the best observed outcome for any control patient at that time. Total OBAS score was log transformed.||1.13|0.85|0.75
71090041|NCT03743194|141686462|SUPERIORITY||Geometric mean ratio|0.97||||0.71|TWO_SIDED|95.0|0.83|1.14|||linear mixed model|||A complete-case analysis (assumed that one patient was missing at random) was conducted as a sensitivity analysis. The ratio of geometric means (treatment vs control) was estimated using a mixed effects linear model with repeated measures assuming an auto-regressive AR(1) correlation structure.||1.14|0.83|0.71
71090042|NCT03743194|141686462|SUPERIORITY||Median Difference (Final Values)|0.08||||0.69|TWO_SIDED|95.0|-0.5|0.67|||Wilcoxon (Mann-Whitney)|||The total OBAS was averaged over 3 postoperative days for the sensitivity analysis. A Wilcoxon rank-sum test with Hodges-Lehmann estimation was used to estimate the median of differences (each OBAS in the treatment group was compared with each OBAS in the control group to calculate the difference)||0.67|-0.5|0.69
71090043|NCT03743194|141686463|SUPERIORITY|The ratio of geometric means was estimated through a generalized linear model with log transformed cumulative opioid consumption as the outcome and treatment group as the exposure. A multiple testing adjustment was applied (0.05/4 = 0.0125), thus 98.75% CI was provided.|Geometric mean ratio|1.01||||0.94|TWO_SIDED|98.75|0.73|1.4|||Regression, Linear|||||1.40|0.73|0.94
71090044|NCT03743194|141686464|SUPERIORITY|Difference in means at POD1|Mean Difference (Final Values)|0.08||||0.36|TWO_SIDED|99.6|-0.17|0.32|||Linear mixed model|||The difference in means was estimated through a mixed effects linear model with repeated measures assuming an auto-regressive correlation structure. Treatment effect was reported each day separately due to significant time-treatment interaction.||0.32|-0.17|0.36
71090045|NCT03743194|141686464|SUPERIORITY|Difference in mean at POD2|Mean Difference (Final Values)|-0.02||||0.79|TWO_SIDED|99.6|-0.26|0.22|||Linear mixed model|||The difference in means was estimated through a mixed effects linear model with repeated measures assuming an auto-regressive correlation structure. Treatment effect was reported each day separately due to significant time-treatment interaction.||0.22|-0.26|0.79
71090046|NCT03743194|141686464|SUPERIORITY|Difference in mean at POD3|Mean Difference (Final Values)|-0.07||||0.39|TWO_SIDED|99.6|-0.31|0.17|||Linear mixed model|||The difference in means was estimated through a mixed effects linear model with repeated measures assuming an auto-regressive correlation structure. Treatment effect was reported each day separately due to significant time-treatment interaction.||0.17|-0.31|0.39
71090047|NCT03743194|141686465|SUPERIORITY|Difference in mean in POD1|Mean Difference (Final Values)|0.07||||0.51|TWO_SIDED|99.6|-0.25|0.4|||Linear mixed model|||The difference in means was estimated through a mixed effects linear model with repeated measures assuming an auto-regressive correlation structure. Treatment effect was reported each day separately due to significant time-treatment interaction.||0.4|-0.25|0.51
71090048|NCT03743194|141686465|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.91|TWO_SIDED|99.6|-0.33|0.3||Mean difference at POD2|Linear mixed model|||The difference in means was estimated through a mixed effects linear model with repeated measures assuming an auto-regressive correlation structure. Treatment effect was reported each day separately due to significant time-treatment interaction.||0.30|-0.33|0.91
71090049|NCT03743194|141686465|SUPERIORITY|Difference in mean at POD3|Mean Difference (Final Values)|-0.11||||0.31|TWO_SIDED|99.6|-0.43|0.21|||Linear mixed model|||The difference in means was estimated through a mixed effects linear model with repeated measures assuming an auto-regressive correlation structure. Treatment effect was reported each day separately due to significant time-treatment interaction.||0.21|-0.43|0.31
70858002|NCT03036800|141202113|SUPERIORITY||Mean Difference (Net)|-5.51||||0.003|TWO_SIDED|95.0|-9.09|-1.94|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute waist circumference change (cm) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-1.94|-9.09|0.003
71090050|NCT03743194|141686466|SUPERIORITY|Difference in means at POD1|Mean Difference (Final Values)|0.22||||0.36|TWO_SIDED|99.6|-0.47|0.91|||Linear mixed model|||The difference in means was estimated through a mixed effects linear model with repeated measures assuming an auto-regressive correlation structure. Treatment effect was reported each day separately due to significant time-treatment interaction.||0.91|-0.47|0.36
71127047|NCT01597635|141760172|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.1681|TWO_SIDED|95.0|0.694|1.129|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||1.129|0.694|0.1681
71127048|NCT01597635|141760172|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.85||||0.0877|TWO_SIDED|95.0|0.669|1.075|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 4 hours||1.075|0.669|0.0877
71127049|NCT01597635|141760172|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.2011|TWO_SIDED|95.0|0.715|1.159|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||1.159|0.715|0.2011
71127050|NCT01597635|141760172|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.06||||0.6855|TWO_SIDED|95.0|0.842|1.345|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 8 hours||1.345|0.842|0.6855
71127051|NCT01597635|141760172|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.04||||0.6093|TWO_SIDED|95.0|0.8|1.325|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.325|0.800|0.6093
71127052|NCT01597635|141760172|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.435|TWO_SIDED|95.0|0.765|1.253|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 18 hours||1.253|0.765|0.4350
71127053|NCT01597635|141760172|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.2232|TWO_SIDED|95.0|0.722|1.195|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.195|0.722|0.2232
71127054|NCT01597635|141760172|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.93||||0.2716|TWO_SIDED|95.0|0.733|1.2|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24.5 hours||1.200|0.733|0.2716
71127055|NCT01597635|141760172|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.93||||0.2866|TWO_SIDED|95.0|0.726|1.19|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 25 hours||1.190|0.726|0.2866
71127056|NCT01597635|141760172|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.5033|TWO_SIDED|95.0|0.78|1.27|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 26 hours||1.270|0.780|0.5033
71127057|NCT01597635|141760172|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.88||||0.1493|TWO_SIDED|95.0|0.684|1.12|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 28 hours||1.120|0.684|0.1493
71127058|NCT01597635|141760172|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.4947|TWO_SIDED|95.0|0.759|1.301|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 30 hours||1.301|0.759|0.4947
70858003|NCT03036800|141202133|SUPERIORITY||Odds Ratio (OR)|10.53|||<|0.001|TWO_SIDED|95.0|3.83|28.97|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥5% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||28.97|3.83|<0.001
71127059|NCT01597635|141760172|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.89||||0.1951|TWO_SIDED|95.0|0.678|1.161|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 32 hours||1.161|0.678|0.1951
71127060|NCT01597635|141760172|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.8||||0.0512|TWO_SIDED|95.0|0.612|1.05|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 36 hours||1.050|0.612|0.0512
71127061|NCT01597635|141760172|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.47|TWO_SIDED|95.0|0.775|1.279|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 42 hours||1.279|0.775|0.4700
71127062|NCT01597635|141760172|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.634|TWO_SIDED|95.0|0.811|1.368|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.368|0.811|0.6340
71127063|NCT01597635|141760172|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.2129|TWO_SIDED|95.0|0.689|1.183|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||1.183|0.689|0.2129
71127064|NCT01597635|141760172|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.6418|TWO_SIDED|95.0|0.798|1.411|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 49 hours||1.411|0.798|0.6418
71127065|NCT01597635|141760172|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4797|TWO_SIDED|95.0|0.754|1.315|||Ratio of Active/Placebo|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||1.315|0.754|0.4797
71127066|NCT01597635|141760172|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.2659|TWO_SIDED|95.0|0.703|1.199|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 52 hours||1.199|0.703|0.2659
71127067|NCT01597635|141760172|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.2102|TWO_SIDED|95.0|0.687|1.159|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||1.159|0.687|0.2102
71127068|NCT01597635|141760172|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.3623|TWO_SIDED|95.0|0.74|1.24|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 56 hours||1.240|0.740|0.3623
71127069|NCT01597635|141760172|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.95||||0.3499|TWO_SIDED|95.0|0.73|1.225|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||1.225|0.730|0.3499
71127070|NCT01597635|141760172|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.6494|TWO_SIDED|95.0|0.787|1.377|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||1.377|0.787|0.6494
71127071|NCT01597635|141760172|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.02||||0.5567|TWO_SIDED|95.0|0.766|1.358|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.358|0.766|0.5567
71127072|NCT01597635|141760172|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.85||||0.1095|TWO_SIDED|95.0|0.615|1.073|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 168 hours||1.073|0.615|0.1095
71127073|NCT01597635|141760173|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.06||||0.6098|TWO_SIDED|95.0|0.721|1.644|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||1.644|0.721|0.6098
71127074|NCT01597635|141760173|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.35||||0.9441|TWO_SIDED|95.0|0.931|2.068|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 1 hour||2.068|0.931|0.9441
70858004|NCT03036800|141202134|SUPERIORITY||Odds Ratio (OR)|23.1|||<|0.001|TWO_SIDED|95.0|7.55|70.67|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||70.67|7.55|<0.001
70858005|NCT03036800|141202137|SUPERIORITY||Odds Ratio (OR)|7.71|||<|0.001|TWO_SIDED|95.0|2.75|21.6|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||21.60|2.75|<0.001
70858006|NCT03036800|141202138|SUPERIORITY||Odds Ratio (OR)|6.14||||0.032|TWO_SIDED|95.0|1.16|32.32|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||32.32|1.16|0.032
71127075|NCT01597635|141760173|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.12||||0.7173|TWO_SIDED|95.0|0.749|1.621|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||1.621|0.749|0.7173
71127076|NCT01597635|141760173|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.26||||0.8292|TWO_SIDED|95.0|0.81|1.949|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 4 hours||1.949|0.810|0.8292
71127077|NCT01597635|141760173|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.23||||0.8008|TWO_SIDED|95.0|0.775|1.832|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||1.832|0.775|0.8008
71127078|NCT01597635|141760173|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.2||||0.7905|TWO_SIDED|95.0|0.776|1.799|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 8 hours||1.799|0.776|0.7905
71127079|NCT01597635|141760173|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.17||||0.7566|TWO_SIDED|95.0|0.737|1.958|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.958|0.737|0.7566
71127080|NCT01597635|141760173|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.25||||0.8349|TWO_SIDED|95.0|0.812|2.05|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 18 hours||2.050|0.812|0.8349
71127081|NCT01597635|141760173|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4739|TWO_SIDED|95.0|0.713|1.527|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.527|0.713|0.4739
71127082|NCT01597635|141760173|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.06||||0.6291|TWO_SIDED|95.0|0.763|1.647|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24.5 hours||1.647|0.763|0.6291
71127083|NCT01597635|141760173|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.18||||0.8032|TWO_SIDED|95.0|0.83|1.814|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 25 hours||1.814|0.830|0.8032
71127084|NCT01597635|141760173|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.325|TWO_SIDED|95.0|0.626|1.416|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 26 hours||1.416|0.626|0.3250
71127085|NCT01597635|141760173|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.5828|TWO_SIDED|95.0|0.687|1.63|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 28 hours||1.630|0.687|0.5828
71127086|NCT01597635|141760173|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.4546|TWO_SIDED|95.0|0.661|1.512|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 30 hours||1.512|0.661|0.4546
71127087|NCT01597635|141760173|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.06||||0.6158|TWO_SIDED|95.0|0.719|1.639|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 32 hours||1.639|0.719|0.6158
71127088|NCT01597635|141760173|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.17||||0.7748|TWO_SIDED|95.0|0.752|1.77|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 36 hours||1.770|0.752|0.7748
71127089|NCT01597635|141760173|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.09||||0.6565|TWO_SIDED|95.0|0.686|1.714|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 42 hours||1.714|0.686|0.6565
71127090|NCT01597635|141760173|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.87||||0.2773|TWO_SIDED|95.0|0.566|1.38|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.380|0.566|0.2773
71127091|NCT01597635|141760173|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.3606|TWO_SIDED|95.0|0.61|1.467|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||1.467|0.610|0.3606
71127092|NCT01597635|141760173|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.83||||0.2211|TWO_SIDED|95.0|0.555|1.317|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 49 hours||1.317|0.555|0.2211
71127093|NCT01597635|141760173|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.88||||0.286|TWO_SIDED|95.0|0.587|1.348|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||1.348|0.587|0.2860
71127094|NCT01597635|141760173|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.94||||0.4079|TWO_SIDED|95.0|0.609|1.51|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 52 hours||1.510|0.609|0.4079
71127095|NCT01597635|141760173|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.02||||0.5284|TWO_SIDED|95.0|0.614|1.663|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||1.663|0.614|0.5284
71127096|NCT01597635|141760173|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.3586|TWO_SIDED|95.0|0.568|1.458|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 56 hours||1.458|0.568|0.3586
71127097|NCT01597635|141760173|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.13||||0.6768|TWO_SIDED|95.0|0.672|1.853|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||1.853|0.672|0.6768
71127098|NCT01597635|141760173|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.77||||0.1574|TWO_SIDED|95.0|0.488|1.39|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||1.390|0.488|0.1574
70858007|NCT03036800|141202139|SUPERIORITY||Odds Ratio (OR)|11.48|||<|0.001|TWO_SIDED|95.0|3.8|34.67|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 32 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||34.67|3.80|<0.001
70946444|NCT00846768|141393216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.015||0.0211||95.0|0.005|0.064|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.064|0.005|0.0211
71127099|NCT01597635|141760173|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.39|TWO_SIDED|95.0|0.521|1.584|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.584|0.521|0.3900
71127100|NCT01597635|141760173|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.5915|TWO_SIDED|95.0|0.748|1.516|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 168 hours||1.516|0.748|0.5915
71127101|NCT01597635|141760176|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.88||||0.06828|TWO_SIDED|95.0|0.528|1.501|||Bayesian repeated measures model|||CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.501|0.528|0.06828
71127102|NCT01597635|141760176|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.5674|TWO_SIDED|95.0|0.57|1.609|||Bayesian repeated measures model|||CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.609|0.570|0.5674
71127103|NCT01597635|141760176|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.66||||0.8855|TWO_SIDED|95.0|0.321|1.316|||Bayesian repeated measures model|||CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.316|0.321|0.8855
71127104|NCT01597635|141760176|SUPERIORITY||Ratio of Active/Placebo|0.97||||0.5358|TWO_SIDED|95.0|0.531|1.76|||Bayesian repeated measures model|||CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.760|0.531|0.5358
71127105|NCT01597635|141760176|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.17||||0.699|TWO_SIDED|95.0|0.622|2.155|||Bayesian repeated measures model|||CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||2.155|0.622|0.6990
71127106|NCT01597635|141760176|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.513|TWO_SIDED|95.0|0.549|1.721|||Bayesian repeated measures model|||IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.721|0.549|0.5130
71127107|NCT01597635|141760176|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.73||||0.7696|TWO_SIDED|95.0|0.3|1.731|||Bayesian repeated measures model|||IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.731|0.300|0.7696
71127108|NCT01597635|141760176|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.51||||0.9254|TWO_SIDED|95.0|0.203|1.289|||Bayesian repeated measures model|||IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.289|0.203|0.9254
71127109|NCT01597635|141760176|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.72||||0.7088|TWO_SIDED|95.0|0.216|2.419|||Bayesian repeated measures model|||IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||2.419|0.216|0.7088
71127110|NCT01597635|141760176|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.47||||0.8787|TWO_SIDED|95.0|0.112|1.69|||Bayesian repeated measures model|||IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.690|0.112|0.8787
71127111|NCT01597635|141760176|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.7338|TWO_SIDED|95.0|0.714|1.197|||Bayesian repeated measures model|||RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.197|0.714|0.7338
71127112|NCT01597635|141760176|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.4955|TWO_SIDED|95.0|0.703|1.415|||Bayesian repeated measures model|||RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.415|0.703|0.4955
71127113|NCT01597635|141760176|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.5264|TWO_SIDED|95.0|0.541|1.788|||Bayesian repeated measures model|||RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.788|0.541|0.5264
71127114|NCT01597635|141760176|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.6183|TWO_SIDED|95.0|0.454|1.742|||Bayesian repeated measures model|||RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.742|0.454|0.6183
71127115|NCT01597635|141760176|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.03||||0.5291|TWO_SIDED|95.0|0.483|2.118|||Bayesian repeated measures model|||RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||2.118|0.483|0.5291
71127116|NCT01597635|141760176|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.09||||0.74|TWO_SIDED|95.0|0.828|1.448|||Bayesian repeated measures model|||MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.448|0.828|0.7400
71127117|NCT01597635|141760176|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.25||||0.9375|TWO_SIDED|95.0|0.937|1.683|||Bayesian repeated measures model|||MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.683|0.937|0.9375
71127118|NCT01597635|141760176|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.26||||0.9118|TWO_SIDED|95.0|0.896|1.771|||Bayesian repeated measures model|||MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.771|0.896|0.9118
71127119|NCT01597635|141760176|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.43||||0.9217|TWO_SIDED|95.0|0.866|2.382|||Bayesian repeated measures model|||MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||2.382|0.866|0.9217
71127120|NCT01597635|141760176|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.48||||0.8676|TWO_SIDED|95.0|0.73|3.064|||Bayesian repeated measures model|||MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||3.064|0.730|0.8676
71127121|NCT01597635|141760176|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.83||||0.8835|TWO_SIDED|95.0|0.609|1.135|||Bayesian repeated measures model|||Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.135|0.609|0.8835
71127122|NCT01597635|141760176|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.5446|TWO_SIDED|95.0|0.723|1.33|||Bayesian repeated measures model|||Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.330|0.723|0.5446
71127123|NCT01597635|141760176|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.95||||0.6267|TWO_SIDED|95.0|0.679|1.333|||Bayesian repeated measures model|||Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.333|0.679|0.6267
71127124|NCT01597635|141760176|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.88||||0.7668|TWO_SIDED|95.0|0.612|1.26|||Bayesian repeated measures model|||Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.260|0.612|0.7668
70858008|NCT03036800|141202141|SUPERIORITY||Odds Ratio (OR)|13.63||||0.003|TWO_SIDED|95.0|2.47|75.09|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||75.09|2.47|0.003
70858009|NCT03036800|141202142|SUPERIORITY||Odds Ratio (OR)|0.59||||0.601|TWO_SIDED|95.0|0.08|4.24|||Regression, Logistic|||A logistic regression with a binary outcome of maintenance of weight loss of ≥15% at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||4.24|0.08|0.601
70858010|NCT03036800|141202143|SUPERIORITY||Mean Difference (Net)|-6.55|||<|0.001|TWO_SIDED|95.0|-7.81|-5.29|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 16 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-5.29|-7.81|<0.001
70858011|NCT03036800|141202144|SUPERIORITY||Mean Difference (Net)|-9.59|||<|0.001|TWO_SIDED|95.0|-11.3|-7.88|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 32 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-7.88|-11.30|<0.001
71127125|NCT01597635|141760176|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.94||||0.61|TWO_SIDED|95.0|0.588|1.509|||Bayesian repeated measures model|||Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.509|0.588|0.6100
71127126|NCT01597635|141760176|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.68||||0.8159|TWO_SIDED|95.0|0.291|1.623|||Bayesian repeated measures model|||Renin, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.623|0.291|0.8159
71127127|NCT01597635|141760176|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.53||||0.7988|TWO_SIDED|95.0|0.106|2.657|||Bayesian repeated measures model|||Aldosterone, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||2.657|0.106|0.7988
70946445|NCT00846768|141393217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.014||0.1753||95.0|-0.045|0.008|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.008|-0.045|0.1753
71090051|NCT03743194|141686466|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.97|TWO_SIDED|99.6|-0.66|0.67|||Linear mixed model|||The difference in means was estimated through a mixed effects linear model with repeated measures assuming an auto-regressive correlation structure. Treatment effect was reported each day separately due to significant time-treatment interaction.||0.67|-0.66|0.97
71090052|NCT03743194|141686466|SUPERIORITY|Difference in means at POD3|Mean Difference (Final Values)|-0.21||||0.36|TWO_SIDED|99.6|-0.88|0.46|||Linear mixed model|||The difference in means was estimated through a mixed effects linear model with repeated measures assuming an auto-regressive correlation structure. Treatment effect was reported each day separately due to significant time-treatment interaction.||0.46|-0.88|0.36
71090053|NCT01944423|141686467|SUPERIORITY||Logit difference (final values)|0.64|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|95.0|-2.25|0.97||p=ns 2-sided|two-phase growth curve model|||||0.97|-2.25|
71090054|NCT01944423|141686468|SUPERIORITY||Mean Difference (Final Values)|2.43|STANDARD_ERROR_OF_MEAN|1.87||0.038|TWO_SIDED|95.0|0.25|7.94||2-sided|two-phase growth curve model|||At end-of-treatment||7.94|0.25|.038
71090055|NCT01944423|141686469|SUPERIORITY||Mean Difference (Final Values)|3.21|STANDARD_ERROR_OF_MEAN|1.0||0.003|TWO_SIDED|95.0|1.15|5.26||2-sided|two-phase growth curve model|||At 6 month follow-up||5.26|1.15|.003
71090056|NCT01829347|141686470|SUPERIORITY||Hazard Ratio (HR)|0.31||||0.076|TWO_SIDED|95.0|0.085|1.133|||Log Rank|||The primary endpoint was assessed using a Kaplan-Meier survival analysis of the Intent-to-Treat (ITT) population utilizing a log-rank test.||1.133|0.085|0.076
71090057|NCT01829347|141686471|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71090058|NCT03558516|141686524|SUPERIORITY|||||||0.315|||||||Wilcoxon (Mann-Whitney)|||||||0.315
71090059|NCT03558516|141686525|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.270
71090060|NCT03558516|141686526|SUPERIORITY|||||||0.299|||||||Wilcoxon (Mann-Whitney)|||||||0.299
71090061|NCT03363906|141686531|SUPERIORITY||Ratio Geometric Least Squares (LS) Mean|1.04||||0.473|TWO_SIDED|90.0|0.949|1.14|||Mixed Models Analysis|||||1.14|0.949|0.473
71090062|NCT03363906|141686532|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.119|TWO_SIDED|90.0|0.993|1.3|||ANOVA|||||1.30|0.993|0.119
70858012|NCT03036800|141202145|SUPERIORITY||Mean Difference (Net)|-13.51|||<|0.001|TWO_SIDED|95.0|-15.51|-11.51|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-11.51|-15.51|<0.001
71090063|NCT00676143|141686533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.979|TWO_SIDED|95.0|-1.18|1.22||Primary variable ADAS-Cog/11 total score had to reach statistical significance, p-values had to reach p \<=0.05, in order to be declared effective.|Mixed Models Analysis|||"Change in ADAS-Cog/11 total score was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.~The number of participants in each group gave 90% power to detect a 2.21 point advantage for the bapineuzumab group over placebo on the ADAS-Cog/11 total score, at the primary time point (Week 78). This calculation was based on a two-sided test with an alpha of 0.05."||1.22|-1.18|0.979
71090064|NCT00676143|141686534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.973|TWO_SIDED|95.0|-2.51|2.6||Primary variable DAD total score had to reach statistical significance, p-values had to reach p \<=0.05, in order to be declared effective.|Mixed Models Analysis|||"Change in DAD total score was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.~The number of participants in each group gave 90% power to detect a 5.39 unit advantage for the bapineuzumab group over placebo on the DAD total score, at the primary time point (Week 78). This calculation was based on a two-sided test with an alpha of 0.05."||2.60|-2.51|0.973
71090065|NCT00676143|141686535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.159|TWO_SIDED|95.0|-0.17|0.03|||Mixed Models Analysis|||"Change in PIB PET SUVr was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.~The number of participants gave 90% power to detect a 0.152 unit advantage for the bapineuzumab group over placebo for PiB PET binding at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05."||0.03|-0.17|0.159
71127128|NCT01597635|141760177|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.12||||0.6536|TWO_SIDED|95.0|0.626|2.024|||Bayesian repeated measures model|||CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||2.024|0.626|0.6536
71127129|NCT01597635|141760177|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.3||||0.9066|TWO_SIDED|95.0|0.876|1.955|||Bayesian repeated measures model|||CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.955|0.876|0.9066
71127130|NCT01597635|141760177|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.23||||0.7859|TWO_SIDED|95.0|0.723|2.066|||Bayesian repeated measures model|||CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||2.066|0.723|0.7859
71127131|NCT01597635|141760177|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.6058|TWO_SIDED|95.0|0.413|1.963|||Bayesian repeated measures model|||CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.963|0.413|0.6058
71127132|NCT01597635|141760177|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.29||||0.6921|TWO_SIDED|95.0|0.456|3.632|||Ratio of Active/Placebo|||CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||3.632|0.456|0.6921
71127133|NCT01597635|141760178|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.7934|TWO_SIDED|95.0|0.737|1.14|||Bayesian repeated measures model|||CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.140|0.737|0.7934
71127134|NCT01597635|141760178|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.01||||0.5205|TWO_SIDED|95.0|0.782|1.317|||Bayesian repeated measures model|||CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.317|0.782|0.5205
71127135|NCT01597635|141760178|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.12||||0.6682|TWO_SIDED|95.0|0.673|1.865|||Bayesian repeated measures model|||CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.865|0.673|0.6682
71127136|NCT01597635|141760178|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.5304|TWO_SIDED|95.0|0.744|1.315|||Bayesian repeated measures model|||CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.315|0.744|0.5304
70946446|NCT00846768|141393217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.013|STANDARD_ERROR_OF_MEAN|0.014||0.3444||95.0|-0.04|0.014|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.014|-0.040|0.3444
70858013|NCT03036800|141202146|SUPERIORITY||Mean Difference (Net)|-9.3|||<|0.001|TWO_SIDED|95.0|-12.35|-6.26|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-6.26|-12.35|<0.001
70858014|NCT03036800|141202147|SUPERIORITY||Mean Difference (Net)|-6.16|||<|0.001|TWO_SIDED|95.0|-7.03|-5.28|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute BMI change (kg/m2) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-5.28|-7.03|<0.001
70858015|NCT03036800|141202148|SUPERIORITY||Mean Difference (Net)|-4.22|||<|0.001|TWO_SIDED|95.0|-5.56|-2.89|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute BMI change (kg/m2) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-2.89|-5.56|<0.001
70858016|NCT03036800|141202149|SUPERIORITY||Median Difference (Net)|-8.8|||<|0.001|TWO_SIDED|95.0|-11.96|-5.64|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute waist circumference change (cm) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-5.64|-11.96|<0.001
70858017|NCT03036800|141202150|SUPERIORITY||Median Difference (Net)|-9.59||||0.001|TWO_SIDED|95.0|-14.91|-4.27|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute waist circumference change (cm) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-4.27|-14.91|0.001
71127137|NCT01597635|141760178|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.81||||0.9078|TWO_SIDED|95.0|0.582|1.112|||Bayesian repeated measures model|||CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.112|0.582|0.9078
71127138|NCT01597635|141760178|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.26||||0.9907|TWO_SIDED|95.0|1.042|1.526|||Bayesian repeated measures model|||SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.526|1.042|0.9907
71127139|NCT01597635|141760178|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.27||||0.9973|TWO_SIDED|95.0|1.005|1.606|||Bayesian repeated measures model|||SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.606|1.005|0.9973
71127140|NCT01597635|141760178|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.61||||0.9954|TWO_SIDED|95.0|1.13|2.331|||Bayesian repeated measures model|||SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||2.331|1.130|0.9954
71127141|NCT01597635|141760178|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.65||||0.983|TWO_SIDED|95.0|1.045|2.588|||Bayesian repeated measures model|||SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||2.588|1.045|0.9830
71127142|NCT01597635|141760178|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.52||||0.9312|TWO_SIDED|95.0|0.867|2.737|||Bayesian repeated measures model|||SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||2.737|0.867|0.9312
71127143|NCT01963845|141760210|SUPERIORITY_OR_OTHER|||||||0.585|||||||t-test, 2 sided|||||||0.585
71127144|NCT01963845|141760211|SUPERIORITY_OR_OTHER|||||||0.7583|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in AST values from baseline to 24 weeks between the two groups.||||0.7583
71127145|NCT01963845|141760212|SUPERIORITY_OR_OTHER|||||||0.8569|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in ALT values from baseline to 24 weeks between the two groups.||||0.8569
71127146|NCT01963845|141760213|SUPERIORITY_OR_OTHER|||||||0.7984|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in LDL values from baseline to 24 weeks between the two groups.||||0.7984
71127147|NCT01963845|141760214|SUPERIORITY_OR_OTHER|||||||0.556|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in HOMA-IR values from baseline to 24 weeks between the two groups.||||0.5560
71127148|NCT00767806|141760215|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Mixed Models Analysis|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory 24-hour average pain score after 12 weeks of treatment.||||0.001
71127149|NCT00767806|141760216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.002|TWO_SIDED|95.0|-1.12|-0.25||P-value is for BPI severity of worst pain - change|ANCOVA|Main effect model: Change = Treatment + Investigator + Baseline (Type III sums of square)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory severity of worst pain score during 12 weeks of treatment.||-0.25|-1.12|0.002
71127150|NCT00767806|141760216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.006|TWO_SIDED|95.0|-0.85|-0.14||P-value is for BPI severity of least pain - change|ANCOVA|Main effect model: Change = Treatment + Investigator + Baseline (Type III sums of square)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory severity of least pain score during 12 weeks of treatment.||-0.14|-0.85|0.006
71127151|NCT00767806|141760216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86|||<|0.001|TWO_SIDED|95.0|-1.25|-0.46||P-value is for BPI severity of pain right now - change|ANCOVA|Main effect model: Change = Treatment + Investigator + Baseline (Type III sums of square)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory severity of pain right now score during 12 weeks of treatment.||-0.46|-1.25|<0.001
71127152|NCT00767806|141760216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75|||<|0.001|TWO_SIDED|95.0|-1.16|-0.35||P-value is for BPI interference with general activity - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with general activity score during 12 weeks of treatment.||-0.35|-1.16|<0.001
71127153|NCT00767806|141760216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|||<|0.001|TWO_SIDED|95.0|-1.09|-0.34||P-value is for BPI interference with mood score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with mood score during 12 weeks of treatment.||-0.34|-1.09|<0.001
71127154|NCT00767806|141760216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.02|TWO_SIDED|95.0|-0.84|-0.07||P-value is for BPI interference with walking ability - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with walking ability score during 12 weeks of treatment.||-0.07|-0.84|0.020
71127155|NCT00767806|141760216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.012|TWO_SIDED|95.0|-0.9|-0.11||P-value is for BPI interference with normal work - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with normal work score during 12 weeks of treatment.||-0.11|-0.90|0.012
71127156|NCT00767806|141760216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.001|TWO_SIDED|95.0|-0.92|-0.22||P-value is for BPI interference with relations to others - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with relations to others score during 12 weeks of treatment.||-0.22|-0.92|0.001
71127157|NCT00767806|141760216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.002|TWO_SIDED|95.0|-1.13|-0.27||P-value is for BPI interference with sleep score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with sleep score during 12 weeks of treatment.||-0.27|-1.13|0.002
70858018|NCT01077154|141202151|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.7|TWO_SIDED|95.0|0.82|1.14|||Stratified Log Rank|Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.|Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hazard ratio \< 1 favors denosumab.|||1.14|0.82|0.70
70946447|NCT00846768|141393217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.014||0.1161||95.0|-0.005|0.049|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.049|-0.005|0.1161
71090066|NCT00676143|141686536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38||||0.62|TWO_SIDED|95.0|-6.89|4.13|||ANCOVA|||Change in CSF phospho-tau was analyzed using an analysis of covariance (ANCOVA) model. The analysis was based on the treatment difference estimated at Week 71 based on appropriate contrasts or LS means. The number of participants gave 90% power to detect a 13-ng/L advantage in phospho-tau for the bapineuzumab group over placebo at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05.||4.13|-6.89|0.620
71090067|NCT00676143|141686537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.884|TWO_SIDED|95.0|-1.89|1.63|||Mixed Models Analysis|||"Change in MRI BBSI was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.~The number of participants gave 90% power to detect a 4.15-cm3 advantage for the bapineuzumab group over placebo on reduction in brain volume as measured by the BBSI at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05."||1.63|-1.89|0.884
71090068|NCT00676143|141686538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.7|TWO_SIDED|95.0|-0.97|1.45|||Mixed Models Analysis|||Treatment Difference: Bapineuzumab - Placebo||1.45|-0.97|0.700
71090069|NCT00676143|141686539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.949|TWO_SIDED|95.0|-2.61|2.78|||Mixed Models Analysis|||Treatment Difference: Bapineuzumab - Placebo||2.78|-2.61|0.949
71090070|NCT00676143|141686540|SUPERIORITY_OR_OTHER|||||||0.684|||||||Log Rank|||||||0.684
71090071|NCT00676143|141686541|SUPERIORITY_OR_OTHER|||||||0.383|||||||Log Rank|||||||0.383
71090072|NCT00676143|141686542|SUPERIORITY_OR_OTHER|||||||0.191|||||||Log Rank|||||||0.191
71090073|NCT00676143|141686543|SUPERIORITY_OR_OTHER|||||||0.478|||||||Log Rank|||||||0.478
71090074|NCT00676143|141686544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.462|TWO_SIDED|95.0|-0.41|0.13|||Mixed Models Analysis|||Change in DS total score was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.||0.13|-0.41|0.462
71090075|NCT00676143|141686546|SUPERIORITY_OR_OTHER|||||||0.086|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.086
71090076|NCT00676143|141686548|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.120
71090077|NCT00676143|141686549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.448|TWO_SIDED|95.0|-0.55|0.24|||Mixed Models Analysis|||Change in CDR-SOB total score was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.||0.24|-0.55|0.448
71090078|NCT02065557|141686571|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.||||< 0.001
71090079|NCT02065557|141686571|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.||||< 0.001
71090080|NCT02065557|141686571|SUPERIORITY|one-sample two-sided Chi-square test||||||0.382||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.||||0.382
71090081|NCT02065557|141686571|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.||||< 0.001
71090082|NCT02065557|141686571|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.||||< 0.001
71090083|NCT02065557|141686571|SUPERIORITY|one-sample two-sided Chi-square test||||||0.344||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.||||0.344
71090084|NCT02065557|141686572|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
71090085|NCT02065557|141686572|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
71090086|NCT02065557|141686572|SUPERIORITY|one-sample two-sided Chi-square test||||||0.382||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.382
71090087|NCT02065557|141686572|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
71090088|NCT02065557|141686572|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
71090089|NCT02065557|141686572|SUPERIORITY|one-sample two-sided Chi-square test||||||0.344||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.344
71090090|NCT02065557|141686573|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
71090091|NCT02065557|141686573|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)|Chi-squared|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
70872038|NCT01652703|141229480|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-24.25|STANDARD_ERROR_OF_MEAN|11.93||0.044|TWO_SIDED|95.0|-47.83|-0.68||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-0.68|-47.83|0.044
70858019|NCT01077154|141202152|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.57|TWO_SIDED|95.0|0.91|1.19|||Stratified Log Rank|Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.|Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hzard ratio \< 1 favors denosumab.|||1.19|0.91|0.57
70946448|NCT00846768|141393217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.014||0.6789||95.0|-0.033|0.021|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.021|-0.033|0.6789
70946449|NCT00846768|141393217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.014||0.0129||95.0|0.007|0.062|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.062|0.007|0.0129
71090092|NCT02065557|141686573|SUPERIORITY|one-sample two-sided Chi-square test||||||0.008||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)|Chi-squared|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.008
71090093|NCT02065557|141686573|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
71090094|NCT02065557|141686573|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
71090095|NCT02065557|141686573|SUPERIORITY|one-sample two-sided Chi-square test||||||0.038||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.038
71090096|NCT02065557|141686574|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
71090097|NCT02065557|141686574|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
71090098|NCT02065557|141686574|SUPERIORITY|one-sample two-sided Chi-square test||||||0.382||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.382
71090099|NCT02065557|141686574|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
71090100|NCT02065557|141686574|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
71090101|NCT02065557|141686574|SUPERIORITY|one-sample two-sided Chi-square test||||||0.344||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.344
71127158|NCT00767806|141760216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.005|TWO_SIDED|95.0|-0.96|-0.18||P-value is for BPI interference with enjoyment of life score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with enjoyment of life score during 12 weeks of treatment.||-0.18|-0.96|0.005
70858020|NCT01077154|141202153|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.26|TWO_SIDED|95.0|0.92|1.36|||Stratified Log Rank|Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.|Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hazard ratio \< 1 favors denosumab.|||1.36|0.92|0.26
70858021|NCT01077154|141202154|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.94|TWO_SIDED|95.0|0.83|1.22|||Stratified Log Rank|Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.|Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hazard ratio \< 1 favors denosumab.|||1.22|0.83|0.94
70858022|NCT01077154|141202155|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.41|TWO_SIDED|95.0|0.92|1.21|||Stratified Log Rank|Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.|Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hazard ratio \< 1 favors denosumab.|||1.21|0.92|0.41
70946450|NCT00846768|141393218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.017||0.4931||95.0|-0.023|0.047|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.047|-0.023|0.4931
70858023|NCT05985980|141202156|EQUIVALENCE|The null hypothesis is true that the ST/HR index (μV/bpm) ıs similar between the early and late follicular phases||||||0.521|||||||t-test, 2 sided|||||||0.521
70858024|NCT05985980|141202157|EQUIVALENCE|High-sensitive cardiac troponin T (hs-cTnT) levels before and after ETT at the early and late follicular phases are compared.||||||0.109|||||||ANOVA|||High-sensitive cardiac troponin T (hs-cTnT) levels before and after ETT at the early and late follicular phases are compared.||||0.109
70858025|NCT05985980|141202158|EQUIVALENCE|ETT maximal exercise capacity (METs score) is compared between the early and late follicular phases of menstrual cycle||||||0.111|||||||t-test, 2 sided|||ETT maximal exercise capacity (METs score) is compared between the early and late follicular phases of menstrual cycle||||0.111
70858026|NCT05985980|141202159|EQUIVALENCE|ETT ST/HR slope (μV/bpm) is compared between the early and late follicular phases of menstrual cycle||||||0.414|||||||t-test, 2 sided|||ETT ST/HR slope (μV/bpm) is compared between the early and late follicular phases of menstrual cycle||||0.414
70872039|NCT01652703|141229480|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-29.82|STANDARD_ERROR_OF_MEAN|9.36||0.002|TWO_SIDED|95.0|-48.32|-11.32||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-11.32|-48.32|0.002
71127159|NCT00767806|141760216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|||<|0.001|TWO_SIDED|95.0|-0.92|-0.25||P-value is for BPI average interference score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory average interference score during 12 weeks of treatment.||-0.25|-0.92|<0.001
71127160|NCT00767806|141760217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.05|-0.35||p-value is for weekly 24-hour average pain rating score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the weekly 24-hour average pain rating score during 12 weeks of treatment.||-0.35|-1.05|<0.001
71127161|NCT00767806|141760217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|||<|0.001|TWO_SIDED|95.0|-1.08|-0.33||p-value is for weekly 24-hour worst pain score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the weekly 24-hour worst pain score during 12 weeks of treatment.||-0.33|-1.08|<0.001
71127162|NCT00767806|141760217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.004|TWO_SIDED|95.0|-0.87|-0.17||p-value is for weekly 24-hour night pain score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the weekly 24-hour night pain score during 12 weeks of treatment.||-0.17|-0.87|0.004
71127163|NCT00767806|141760218|SUPERIORITY_OR_OTHER|||||||0.108||95.0||||p-value is for number of patients who achieve a \>=30% reduction of the Brief Pain Inventory average pain severity rating - difference between placebo and duloxetine|Fisher Exact|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in number of patients who achieve a \>=30% reduction of the Brief Pain Inventory average pain severity rating after 12 weeks of treatment.||||0.108
71127164|NCT00767806|141760219|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||p-value is for number of patients who achieve a \>=50% reduction of the Brief Pain Inventory average pain severity rating - difference between placebo and duloxetine|Fisher Exact|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in number of patients who achieve a \>=50% reduction of the Brief Pain Inventory average pain severity rating after 12 weeks of treatment.||||0.006
71127165|NCT00767806|141760220|SUPERIORITY_OR_OTHER|||||||0.082||95.0||||p-value is difference between duloxetine and placebo in number of patients who achieve criteria described in null hypothesis|Fisher Exact|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in number of patients who achieve a \>=30% reduction of the Brief Pain Inventory (BPI) average pain severity rating from baseline to endpoint and baseline to earlier visit than last visit and maintains a \>=20% reduction of BPI average pain rating from baseline at every visit.||||0.082
71127166|NCT00767806|141760221|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||p-value is for difference between duloxetine and placebo groups in the empirical overall cumulated distribution of the percentage pain reduction|Kolnogorov-Smirnov test|||Tested was the null hypothesis that there is no difference between duloxetine and placebo groups in the empirical cumulated distribution of the percentage pain reduction.||||0.013
71127167|NCT00767806|141760222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.077|TWO_SIDED|95.0|-0.33|0.02||p-value is for difference between placebo and duloxetine groups in change of the Clinical Global Impression of Severity score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Clinical Global Impression of Severity score after 12 weeks of treatment.||0.02|-0.33|0.077
71127168|NCT00767806|141760223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.011|TWO_SIDED|95.0|-0.56|-0.07||p-value is for difference between placebo and duloxetine groups Patient's Global Impression of Improvement endpoint value|ANCOVA|Main Effect Model: PGI-I=Treatment+Investigator+Baseline(Type III sums of squares). PGI-Severity score from baseline visit was used as the baseline.||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups Patient's Global Impression of Improvement endpoint value during 12 weeks of treatment.||-0.07|-0.56|0.011
71127169|NCT00767806|141760224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.255|TWO_SIDED|95.0|-1.28|0.34||p-value is for difference between placebo and duloxetine groups in change of the Roland Morris Disability Questionnaire total score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Roland Morris Disability Questionnaire total score during 12 weeks of treatment.||0.34|-1.28|0.255
71127170|NCT00767806|141760225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|||<|0.001|TWO_SIDED|95.0|-1.38|-0.37||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Tension-Anxiety subscore|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Tension-Anxiety subscore during 12 weeks of treatment.||-0.37|-1.38|<0.001
71127171|NCT00767806|141760225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.133|TWO_SIDED|95.0|-0.9|0.12||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Depression-Dejection subscore|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Depression-Dejection subscore during 12 weeks of treatment.||0.12|-0.90|0.133
71127172|NCT00767806|141760225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92|||<|0.001|TWO_SIDED|95.0|-1.46|-0.37||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Anger-Hostility score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Anger-Hostility score during 12 weeks of treatment.||-0.37|-1.46|<0.001
71127173|NCT00767806|141760225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.13||||0.003|TWO_SIDED|95.0|0.38|1.88||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Vigor-Activity score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Vigor-Activity score during 12 weeks of treatment.||1.88|0.38|0.003
71127174|NCT00767806|141760225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.469|TWO_SIDED|95.0|-0.93|0.43||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Fatigue-Inertia score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Fatigue-Inertia score during 12 weeks of treatment.||0.43|-0.93|0.469
71127175|NCT00767806|141760225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.006|TWO_SIDED|95.0|-0.98|-0.17||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Confusion-Bewilderment score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Confusion-Bewilderment score during 12 weeks of treatment.||-0.17|-0.98|0.006
71127176|NCT00767806|141760225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.001|TWO_SIDED|95.0|-6.41|-1.6||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Total Mood Disturbance score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Total Mood Disturbance score during 12 weeks of treatment.||-1.60|-6.41|0.001
71127177|NCT00767806|141760226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24||||0.168|TWO_SIDED|95.0|-0.53|3.02||p-value is for difference between placebo and duloxetine groups in change of the 36-SF Health Survey Physical Component score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the 36-SF Health Survey Physical Component score during 12 weeks of treatment.||3.02|-0.53|0.168
71127178|NCT00767806|141760226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.24||||0.01|TWO_SIDED|95.0|0.53|3.96||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Mental Component score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Mental Component score during 12 weeks of treatment.||3.96|0.53|0.010
71090102|NCT02065557|141686575|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
71090103|NCT02065557|141686575|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
71127179|NCT00767806|141760226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.58||||0.016|TWO_SIDED|95.0|0.86|8.3||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Bodily Pain Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Bodily Pain Transformed score during 12 weeks of treatment.||8.30|0.86|0.016
71127180|NCT00767806|141760226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.88|||<|0.001|TWO_SIDED|95.0|2.15|7.61||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Mental Health Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Mental Health Transformed score during 12 weeks of treatment.||7.61|2.15|<0.001
71127181|NCT00767806|141760226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.58||||0.101|TWO_SIDED|95.0|-0.5|5.67||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey General Health Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey General Health Transformed score during 12 weeks of treatment.||5.67|-0.50|0.101
71127182|NCT00767806|141760226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.058|TWO_SIDED|95.0|-0.12|7.12||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Physical Functioning Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Physical Functioning Transformed score during 12 weeks of treatment.||7.12|-0.12|0.058
71127183|NCT00767806|141760226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.43||||0.227|TWO_SIDED|95.0|-1.52|6.37||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Role-Emotional Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Role-Emotional Transformed score during 12 weeks of treatment.||6.37|-1.52|0.227
71127184|NCT00767806|141760226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.91||||0.383|TWO_SIDED|95.0|-2.39|6.21||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Role-Physical Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Role-Physical Transformed score during 12 weeks of treatment.||6.21|-2.39|0.383
71127185|NCT00767806|141760226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0||||0.03|TWO_SIDED|95.0|0.38|7.61||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Social Functioning Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Social Functioning Transformed score during 12 weeks of treatment.||7.61|0.38|0.030
71127186|NCT00767806|141760226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1||||0.022|TWO_SIDED|95.0|0.59|7.6||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Vitality Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Vitality Transformed score during 12 weeks of treatment.||7.60|0.59|0.022
70946451|NCT00846768|141393218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.017||0.2597||95.0|-0.015|0.054|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.054|-0.015|0.2597
71127187|NCT00767806|141760227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|||<|0.001|TWO_SIDED|95.0|0.03|0.12||p-value is for difference between placebo and duloxetine groups in change of the European Quality of Life Questionnaire - 5 Dimension - United Kingdom population-based Index score|ANCOVA|Main Effect Model: Change = Treatment + Investigator (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the European Quality of Life Questionnaire - 5 Dimension - United Kingdom population-based Index score during 12 weeks of treatment.||0.12|0.03|<0.001
71127188|NCT00767806|141760227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.002|TWO_SIDED|95.0|0.02|0.08||p-value is for difference between placebo and duloxetine groups in change of the European Quality of Life Questionnaire - 5 Dimension - United States population-based index score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the European Quality of Life Questionnaire - 5 Dimension - United States population-based index score during 12 weeks of treatment.||0.08|0.02|0.002
71127189|NCT00767806|141760228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.461|TWO_SIDED|95.0|-0.03|0.06||p-value is for difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Absenteeism score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Absenteeism score during 12 weeks of treatment.||0.06|-0.03|0.461
71127190|NCT00767806|141760228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.374|TWO_SIDED|95.0|-0.09|0.03||p-value is for difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Presenteeism score|ANCOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Presenteeism score during 12 weeks of treatment.||0.03|-0.09|0.374
71127191|NCT00767806|141760228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.557|TWO_SIDED|95.0|-0.09|0.05||p-value is for difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Work Productivity Loss score|ANCOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Work Productivity Loss score during 12 weeks of treatment.||0.05|-0.09|0.557
71127192|NCT00767806|141760228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.007|TWO_SIDED|95.0|-0.1|-0.02||p-value is for difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Activity Impairment score|ANCOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Activity Impairment score during 12 weeks of treatment.||-0.02|-0.10|0.007
71127193|NCT00767806|141760230|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||p-value is for difference between placebo and duloxetine groups in uric acid - change|ANOVA|Change Variable = Treatment + Investigator (Type III sums of squares). Rank-transformed change was used as change variable in the ANOVA model.||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of uric acid during 12 weeks of treatment.||||0.010
71127194|NCT00767806|141760231|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||p-value is for difference between duloxetine and placebo in albumin - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of Albumin during 12 weeks of treatment.||||0.031
71127195|NCT00767806|141760232|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||p-value is for difference between duloxetine and placebo in alkaline phosphatase - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of alkaline phosphatase during 12 weeks of treatment.||||0.004
71127196|NCT00767806|141760233|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||p-value is for difference between duloxetine and placebo in alanine aminotransferase - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of Alanine Aminotransferase during 12 weeks of treatment.||||0.013
71127197|NCT00767806|141760234|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||p-value for difference between duloxetine and placebo in aspartate aminotransferase - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of aspartate aminotransferase during 12 weeks of treatment.||||0.039
71127198|NCT00767806|141760235|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||p-value is for difference between duloxetine and placebo in creatinine - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of creatinine during 12 weeks of treatment.||||0.024
71127199|NCT00767806|141760236|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||p-value is for difference between duloxetine and placebo in total protein - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of total protein during 12 weeks of treatment.||||0.019
71127200|NCT00767806|141760237|SUPERIORITY_OR_OTHER|||||||0.329||95.0||||p-value is for difference between placebo and duloxetine groups in change of systolic blood pressure|ANOVA|Main Effect Model: Change = Treatment + Investigator (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of systolic blood pressure during 12 weeks of treatment.||||0.329
71127201|NCT00767806|141760237|SUPERIORITY_OR_OTHER|||||||0.562||95.0||||p-value is for difference between placebo and duloxetine groups in change of diastolic blood pressure|ANOVA|Main Effect Model: Change = Treatment + Investigator (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of diastolic blood pressure during 12 weeks of treatment.||||0.562
71127202|NCT00767806|141760239|SUPERIORITY_OR_OTHER|||||||0.68||95.0||||p-value is for difference between duloxetine and placebo in pulse rate - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of pulse rate during 12 weeks of treatment.||||0.680
71127203|NCT00858208|141760244|SUPERIORITY_OR_OTHER|||||||0.0072|TWO_SIDED||||||paired t-test|||||||0.0072
71127204|NCT00858208|141760245|SUPERIORITY_OR_OTHER|||||||0.0433|TWO_SIDED||||||paired t-test|||Change from baseline at Week 6||||0.0433
71127205|NCT00858208|141760245|SUPERIORITY_OR_OTHER|||||||0.0133|TWO_SIDED||||||paired t-test|||Change from baseline at Week 12||||0.0133
71127206|NCT00858208|141760245|SUPERIORITY_OR_OTHER|||||||0.0278|TWO_SIDED||||||paired t-test|||Change from baseline at Week 18||||0.0278
71127207|NCT00858208|141760245|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||paired t-test|||Change from baseline at Week 24||||0.0160
71127208|NCT00858208|141760245|SUPERIORITY_OR_OTHER|||||||0.0264|TWO_SIDED||||||paired t-test|||Change from baseline at Week 30||||0.0264
71127209|NCT00858208|141760245|SUPERIORITY_OR_OTHER|||||||0.0278|TWO_SIDED||||||paired t-test|||Change from baseline at Week 36||||0.0278
71127210|NCT00858208|141760245|SUPERIORITY_OR_OTHER|||||||0.1854|TWO_SIDED||||||paired t-test|||Change from baseline at Week 42||||0.1854
71127211|NCT00858208|141760245|SUPERIORITY_OR_OTHER|||||||0.1684|TWO_SIDED||||||paired t-test|||Change from baseline at Week 48||||0.1684
71127212|NCT00858208|141760245|SUPERIORITY_OR_OTHER|||||||0.4718|TWO_SIDED||||||paired t-test|||Change from baseline at Week 54||||0.4718
71127213|NCT00858208|141760245|SUPERIORITY_OR_OTHER|||||||0.434|TWO_SIDED||||||paired t-test|||Change from baseline at Week 60||||0.4340
71127214|NCT00858208|141760245|SUPERIORITY_OR_OTHER|||||||0.7765|TWO_SIDED||||||paired t-test|||Change from baseline at Week 66||||0.7765
71127215|NCT00858208|141760245|SUPERIORITY_OR_OTHER|||||||0.7544|TWO_SIDED||||||paired t-test|||Change from baseline at Week 72||||0.7544
71127216|NCT00858208|141760245|SUPERIORITY_OR_OTHER|||||||0.7201|TWO_SIDED||||||paired t-test|||Change from baseline at Week 84||||0.7201
71127217|NCT00858208|141760245|SUPERIORITY_OR_OTHER|||||||0.5692|TWO_SIDED||||||paired t-test|||Change from baseline at Week 90||||0.5692
71127218|NCT00858208|141760245|SUPERIORITY_OR_OTHER|||||||0.2749|TWO_SIDED||||||paired t-test|||Change from baseline at Week 96||||0.2749
71127219|NCT00858208|141760245|SUPERIORITY_OR_OTHER|||||||0.2749|TWO_SIDED||||||paired t-test|||Change from baseline at Week 102||||0.2749
70858027|NCT05985980|141202160|EQUIVALENCE|Maximal horizontal or down slope ST segment depression (mm) during exercise treadmill test is compared between the early and late follicular phases of menstrual cycle||||||0.062|||||||t-test, 2 sided|||Maximal horizontal or down slope ST segment depression (mm) during exercise treadmill test is compared between the early and late follicular phases of menstrual cycle||||0.062
71127220|NCT00858208|141760247|SUPERIORITY_OR_OTHER|||||||0.297|TWO_SIDED||||||paired t-test|||Change at Month 6||||0.2970
71127221|NCT00858208|141760247|SUPERIORITY_OR_OTHER|||||||0.1392|TWO_SIDED||||||paired t-test|||Change at Month 12||||0.1392
71127222|NCT00858208|141760247|SUPERIORITY_OR_OTHER|||||||0.0573|TWO_SIDED||||||paired t-test|||Change at Month 18||||0.0573
71127223|NCT00858208|141760247|SUPERIORITY_OR_OTHER|||||||0.7625|TWO_SIDED||||||paired t-test|||Change at Month 24||||0.7625
71127224|NCT00858208|141760248|SUPERIORITY_OR_OTHER|||||||0.2759|TWO_SIDED||||||paired t-test|||||||0.2759
71127225|NCT01393639|141760258|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.0|||||TWO_SIDED|60.0|5.0|15.0|||||Superiority criterion versus placebo: Lower bound of 60% credible interval \>20%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||15|5|
71127226|NCT01393639|141760258|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|24.0|||||TWO_SIDED|60.0|18.0|31.0|||||Superiority criterion versus placebo: Lower bound of 60% credible interval \>20%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||31|18|
71127227|NCT01393639|141760258|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|32.0|||||TWO_SIDED|60.0|25.0|39.0|||||Superiority criterion versus placebo: Lower bound of 60% credible interval \>20%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||39|25|
70858028|NCT05985980|141202161|EQUIVALENCE|Estrogen levels increase at the late follicular phase.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71127228|NCT01393639|141760258|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|36.0|||||TWO_SIDED|60.0|29.0|43.0|||||Superiority criterion versus placebo: Lower bound of 60% credible interval \>20%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||43|29|
71127229|NCT01393639|141760258|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.0|||||TWO_SIDED|60.0|6.0|22.0|||||Superiority criterion versus placebo: Lower bound of 60% credible interval \>20%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||22|6|
71127230|NCT01393639|141760258|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|34.0|||||TWO_SIDED|60.0|27.0|42.0|||||Superiority criterion versus placebo: Lower bound of 60% credible interval \>20%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||42|27|
71127231|NCT01393639|141760258|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-24.0|||||TWO_SIDED|60.0|-32.0|-17.0|||||Non inferiority criterion versus prednisone 10 mg: Lower bound of 60% credible interval \>-5%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||-17|-32|
71127232|NCT01393639|141760258|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.0|||||TWO_SIDED|60.0|-16.0|-4.0|||||Non inferiority criterion versus prednisone 10 mg: Lower bound of 60% credible interval \>-5%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||-4|-16|
71127233|NCT01393639|141760258|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0|||||TWO_SIDED|60.0|-9.0|4.0|||||Non inferiority criterion versus prednisone 10 mg: Lower bound of 60% credible interval \>-5%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||4|-9|
71127234|NCT01393639|141760258|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0|||||TWO_SIDED|60.0|-5.0|8.0|||||Non inferiority criterion versus prednisone 10 mg: Lower bound of 60% credible interval \>-5%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||8|-5|
71127235|NCT01393639|141760259|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.64|||||TWO_SIDED|95.0|-13.75|17.03|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||17.03|-13.75|
71127236|NCT01393639|141760259|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.71|||||TWO_SIDED|90.0|-22.16|8.75|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||8.75|-22.16|
70858029|NCT02207946|141202162|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.28||0.144|TWO_SIDED|95.0|-1.02|0.16|||ANCOVA|||Least square (LS) means are from analysis of covariance (ANCOVA) with treatment and site included as fixed factors and baseline included as covariate.||0.16|-1.02|0.144
71090104|NCT02065557|141686575|SUPERIORITY|one-sample two-sided Chi-square test||||||0.292||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.292
71127237|NCT01393639|141760259|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.07|||||TWO_SIDED|90.0|-20.45|10.3|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||10.30|-20.45|
71127238|NCT01393639|141760259|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.74|||||TWO_SIDED|90.0|-27.19|3.72|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||3.72|-27.19|
71127239|NCT01393639|141760260|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.34|||||TWO_SIDED|95.0|-12.92|19.61|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||19.61|-12.92|
71127240|NCT01393639|141760260|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.52|||||TWO_SIDED|90.0|-22.86|9.81|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||9.81|-22.86|
71127241|NCT01393639|141760260|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.22|||||TWO_SIDED|90.0|-12.11|20.55|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||20.55|-12.11|
71127242|NCT01393639|141760260|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.83|||||TWO_SIDED|90.0|-3.49|29.15|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||29.15|-3.49|
71127243|NCT01393639|141760261|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|11.36|||||TWO_SIDED|95.0|-6.84|29.56|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||29.56|-6.84|
71127244|NCT01393639|141760261|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|12.15|||||TWO_SIDED|95.0|-5.88|30.19|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||30.19|-5.88|
71127245|NCT01393639|141760261|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|19.54|||||TWO_SIDED|95.0|0.91|38.17|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||38.17|0.91|
71127246|NCT01393639|141760261|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|22.09|||||TWO_SIDED|95.0|3.6|40.58|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||40.58|3.60|
71127247|NCT01393639|141760261|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.43|||||TWO_SIDED|95.0|-9.38|26.25|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||26.25|-9.38|
71127248|NCT01393639|141760261|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|16.5|||||TWO_SIDED|95.0|-1.84|34.84|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||34.84|-1.84|
71090105|NCT02065557|141686575|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
71090106|NCT02065557|141686575|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
71127249|NCT01393639|141760261|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-8.88|||||TWO_SIDED|95.0|-28.58|10.8|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||10.80|-28.58|
70946452|NCT00846768|141393218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|STANDARD_ERROR_OF_MEAN|0.018||0.0006||95.0|0.027|0.097|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.097|0.027|0.0006
71127250|NCT01393639|141760261|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|15.31|||||TWO_SIDED|95.0|-4.85|35.49|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||35.49|-4.85|
71127251|NCT01393639|141760261|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|26.66|||||TWO_SIDED|95.0|6.8|46.53|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||46.53|6.80|
71127252|NCT01393639|141760261|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|13.19|||||TWO_SIDED|95.0|-7.01|33.4|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||33.40|-7.01|
71127253|NCT01393639|141760261|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.88|||||TWO_SIDED|95.0|-11.56|29.33|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||29.33|-11.56|
71127254|NCT01393639|141760261|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|25.21|||||TWO_SIDED|95.0|5.35|45.07|||||Non-responder imputation was used to handle dropouts.|Week 4 comparisons presented in this section for comparison to placebo.||45.07|5.35|
71127255|NCT01393639|141760261|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|2.22|||||TWO_SIDED|95.0|-17.4|21.85|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||21.85|-17.40|
71127256|NCT01393639|141760261|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|15.6|||||TWO_SIDED|95.0|-4.24|35.45|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||35.45|-4.24|
71127257|NCT01393639|141760261|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|22.22|||||TWO_SIDED|95.0|2.2|42.23|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||42.23|2.20|
71127258|NCT01393639|141760261|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.96|||||TWO_SIDED|95.0|-14.6|24.53|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||24.53|-14.60|
71127259|NCT01393639|141760261|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|15.55|||||TWO_SIDED|95.0|-4.51|35.63|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||35.63|-4.51|
71127260|NCT01393639|141760261|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|23.18|||||TWO_SIDED|95.0|3.31|43.06|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||43.06|3.31|
71127261|NCT01393639|141760261|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-5.13|||||TWO_SIDED|95.0|-24.73|14.45|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||14.45|-24.73|
71127262|NCT01393639|141760261|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.34|||||TWO_SIDED|95.0|-23.79|15.09|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||15.09|-23.79|
70858030|NCT03050775|141202207|SUPERIORITY|||||||0.807|||||||t-test, 2 sided|||||||0.807
71127263|NCT01393639|141760261|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|3.04|||||TWO_SIDED|95.0|-16.94|23.02|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||23.02|-16.94|
70858031|NCT03050775|141202207|SUPERIORITY||Mean Difference (Final Values)|0.076||||0.358|TWO_SIDED|95.0|-0.085|0.237|||ANCOVA|||||0.237|-0.085|0.358
70858032|NCT03050775|141202208|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.823|TWO_SIDED|95.0|-0.3|0.2|||t-test, 2 sided|||\~30 minutes post-induction||0.2|-0.3|0.823
70858033|NCT03050775|141202208|SUPERIORITY||Median Difference (Final Values)|0.0||||0.853|TWO_SIDED|95.0|-0.2|0.3|||t-test, 2 sided|||\~60 minutes post-induction. Data was obtained from 33 subjects in the treatment group.||0.3|-0.2|0.853
70858034|NCT03050775|141202208|SUPERIORITY||Median Difference (Final Values)|0.0||||0.986|TWO_SIDED|95.0|-0.2|0.2|||t-test, 2 sided|||\~120 minutes post-induction||0.2|-0.2|0.986
70858035|NCT03050775|141202209|SUPERIORITY||Odds Ratio (OR)|1.7||||0.54|TWO_SIDED|95.0|0.5|5.9|||Fisher Exact|||Post-operative shivering observed||5.9|0.5|0.540
70858036|NCT03050775|141202210|SUPERIORITY||Median Difference (Final Values)|0.0||||0.672|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||||1|-1|0.672
70858037|NCT03050775|141202211|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.571|TWO_SIDED|95.0|-0.2|0.1|||t-test, 2 sided|||Data was obtained from 32 subjects in the treatment group.||0.1|-0.2|0.571
70858038|NCT03050775|141202212|SUPERIORITY||Odds Ratio (OR)|1.4||||0.619|TWO_SIDED|95.0|0.5|3.7|||Fisher Exact|||||3.7|0.5|0.619
70858039|NCT03050775|141202213|SUPERIORITY||Median Difference (Final Values)|75.0||||0.404|TWO_SIDED|95.0|-100.0|250.0|||Wilcoxon (Mann-Whitney)|||||250|-100|0.404
71127264|NCT01393639|141760261|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|5.59|||||TWO_SIDED|95.0|-14.26|25.45|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||25.45|-14.26|
71127265|NCT01393639|141760261|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-34.1|||||TWO_SIDED|95.0|-53.4|-14.8|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||-14.80|-53.40|
71127266|NCT01393639|141760261|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-9.89|||||TWO_SIDED|95.0|-29.68|9.88|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||9.88|-29.68|
71127267|NCT01393639|141760261|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.44|||||TWO_SIDED|95.0|-18.02|20.92|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||20.92|-18.02|
71127268|NCT01393639|141760261|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-12.02|||||TWO_SIDED|95.0|-31.84|7.79|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||7.79|-31.84|
71127269|NCT01393639|141760261|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-20.96|||||TWO_SIDED|95.0|-40.98|-0.94|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||-0.94|-40.98|
70858040|NCT01206387|141202214|SUPERIORITY_OR_OTHER|||||||0.0003|||||||t-test, 2 sided|||||||0.0003
70858041|NCT01206387|141202215|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70858042|NCT01206387|141202216|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70858043|NCT01206387|141202217|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71127270|NCT01393639|141760261|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-7.58|||||TWO_SIDED|95.0|-27.82|12.65|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||12.65|-27.82|
71127271|NCT01393639|141760261|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-0.96|||||TWO_SIDED|95.0|-21.36|19.43|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||19.43|-21.36|
71127272|NCT01393639|141760261|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-18.22|||||TWO_SIDED|95.0|-38.18|1.73|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||1.73|-38.18|
71127273|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.27|||||TWO_SIDED|95.0|-11.93|7.38|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||7.38|-11.93|
71127274|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.87|||||TWO_SIDED|95.0|-9.15|12.91|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||12.91|-9.15|
70858044|NCT01206387|141202218|SUPERIORITY_OR_OTHER|||||||0.0011|||||||t-test, 2 sided|||||||0.0011
70858045|NCT00706849|141202227|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤ 0.05.|t-test, 2 sided|||Based upon prior clinical study experience with mipomersen, it was estimated that the standard deviation of the percent change in LDL-C is approximately 22%. With 20 patients in the control group and 40 patients in the mipomersen-treated group, this study would have at least 90% power to detect a 20% difference between the 2 treatment groups.||||<0.001
70858046|NCT00706849|141202229|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
70858047|NCT00706849|141202231|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
70858048|NCT00706849|141202233|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
70858049|NCT00706849|141202235|SUPERIORITY_OR_OTHER|||||||0.042||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||0.042
70858050|NCT00706849|141202237|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||<0.001
70858051|NCT00706849|141202239|SUPERIORITY_OR_OTHER|||||||0.023||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||0.023
70858052|NCT00706849|141202241|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||<0.001
70858053|NCT00706849|141202243|SUPERIORITY_OR_OTHER|||||||0.004||||||No adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.004
70858054|NCT00706849|141202245|SUPERIORITY_OR_OTHER|||||||0.207||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||0.207
70858055|NCT00920907|141202260|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.01|||||TWO_SIDED|90.0|0.916|1.114|||Least squared linear regression|||Biocomparability of ipilimumab Process C to ipilimumab Process B was concluded if the 90% confidence intervals (CIs) for the ratio of geometric means for Cmax were contained within 80% to 125%.||1.114|0.916|
71127275|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|2.07|||||TWO_SIDED|95.0|-9.09|13.23|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||13.23|-9.09|
71127276|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|18.71|||||TWO_SIDED|95.0|4.19|33.23|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||33.23|4.19|
71127277|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.59|||||TWO_SIDED|95.0|-13.19|4.0|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||4.00|-13.19|
71127278|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|12.74|||||TWO_SIDED|95.0|-0.92|26.41|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||26.41|-0.92|
71127279|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.22|||||TWO_SIDED|95.0|-14.6|10.16|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||10.16|-14.60|
71127280|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|12.29|||||TWO_SIDED|95.0|-2.9|27.48|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||27.48|-2.90|
71127281|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|24.44|||||TWO_SIDED|95.0|7.71|41.17|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||41.17|7.71|
71127282|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|16.54|||||TWO_SIDED|95.0|0.8|32.29|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||32.29|0.80|
71127283|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.0|||||TWO_SIDED|95.0|-12.98|12.98|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||12.98|-12.98|
70858056|NCT00920907|141202264|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.032|||||TWO_SIDED|90.0|0.922|1.156|||Least squared linear regression|||Biocomparability of ipilimumab Process C to ipilimumab Process B was to be concluded if the 90% confidence intervals (CIs) for the ratio of geometric means for ipilimumab Cmax were contained within 80% to 125%. Point estimates and 90% CIs were constructed for the ratio of geometric means (Process C/Process B) for ipilimumab Cmax.||1.156|0.922|
71127284|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|19.32|||||TWO_SIDED|95.0|3.16|35.48|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||35.48|3.16|
71127285|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.44|||||TWO_SIDED|95.0|-18.46|9.57|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||9.57|-18.46|
71127286|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|12.1|||||TWO_SIDED|95.0|-4.49|28.7|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||28.70|-4.49|
71127287|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|24.44|||||TWO_SIDED|95.0|6.63|42.24|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||42.24|6.63|
71127288|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|26.99|||||TWO_SIDED|95.0|9.33|44.65|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||44.65|9.33|
71127289|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.88|||||TWO_SIDED|95.0|-7.53|25.31|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||25.31|-7.53|
71127290|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|21.4|||||TWO_SIDED|95.0|3.88|38.91|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||38.91|3.88|
71127291|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.88|||||TWO_SIDED|95.0|-6.8|24.57|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||24.57|-6.80|
71127292|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|18.58|||||TWO_SIDED|95.0|1.96|35.2|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||35.20|1.96|
71127293|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|35.55|||||TWO_SIDED|95.0|17.89|53.21|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||53.21|17.89|
71127294|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|29.21|||||TWO_SIDED|95.0|11.94|46.49|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||46.49|11.94|
71127295|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|13.33|||||TWO_SIDED|95.0|-2.96|29.63|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||29.63|-2.96|
71127296|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|32.31|||||TWO_SIDED|95.0|14.83|49.8|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||49.80|14.83|
71127297|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.0|||||TWO_SIDED|95.0|-15.79|15.79|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||15.79|-15.79|
71127298|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|3.49|||||TWO_SIDED|95.0|-12.67|19.67|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||19.67|-12.67|
71127299|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|6.66|||||TWO_SIDED|95.0|-10.13|23.47|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||23.47|-10.13|
71127300|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-0.75|||||TWO_SIDED|95.0|-16.25|14.74|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||14.74|-16.25|
71127301|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.88|||||TWO_SIDED|95.0|-8.19|25.96|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||25.96|-8.19|
71127302|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|6.13|||||TWO_SIDED|95.0|-10.5|22.77|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||22.77|-10.50|
71127303|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-15.01|||||TWO_SIDED|95.0|-28.03|-2.0|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||-2.00|-28.03|
71127304|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-10.86|||||TWO_SIDED|95.0|-24.93|3.19|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||3.19|-24.93|
71127305|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-10.67|||||TWO_SIDED|95.0|-24.83|3.48|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||3.48|-24.83|
71127306|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|5.96|||||TWO_SIDED|95.0|-10.96|22.9|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||22.90|-10.96|
71127307|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-21.54|||||TWO_SIDED|95.0|-37.22|-5.86|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||-5.86|-37.22|
71127308|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-7.03|||||TWO_SIDED|95.0|-25.01|10.95|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||10.95|-25.01|
71127309|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|5.12|||||TWO_SIDED|95.0|-14.17|24.41|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||24.41|-14.17|
70858057|NCT00920907|141202269|SUPERIORITY_OR_OTHER||omnibus conditional F-test|0.4||||0.85||||||Not corrected for multiple testing|F-test|numerator 5 degrees freedom, denominator 782 degrees freedom||Time-by-process interaction. Null hypothesis that the pattern of mean ALC values over time is the same for both processes.||||0.85
70858058|NCT00920907|141202269|SUPERIORITY_OR_OTHER||F-statistic|4.35|||<|0.0001|||||||F-test|numerator 10 degrees freedom, denominator 782 degrees freedom||Overall time effect. Null hypothesis of no mean ALC changes over time in either process group (treatment arm).||||<0.0001
70858059|NCT02616601|141202277|EQUIVALENCE|If the 90% confidence interval on the percentage difference between generic fluorouracil cream and Carac (fluorouracil) cream lesion clearance were contained within the interval -0.20 to +0.20, and each of these percentages was greater than and statistically different (p\<0.05) from the vehicle cream percentage, then generic fluorouracil cream and Carac (fluorouracil) cream were considered to be therapeutically equivalent.|Mean Difference (Net)|0.04|||||TWO_SIDED|90.0|-11.03|11.11|||||90% Wald's confidence interval with a continuity correction for the difference (Generic Fluorouracil Cream - Carac \[Fluorouracil\] Cream) in complete clearance rates.|||11.11|-11.03|
70858060|NCT02616601|141202277|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
70858061|NCT02616601|141202277|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
70858062|NCT04389970|141202280|OTHER|Single group, within subject pre/post change.||||||0.39|||||||t-test, 2 sided|Paired-samples t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no conclusion of significance can be made.||||.39
70858063|NCT04389970|141202281|OTHER|Single group, within subject pre/post change.||||||0.3|||||||t-test, 2 sided|Paired-samples t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.3
70858064|NCT04389970|141202282|OTHER|Single group, within subjects pre/post change.||||||0.77|||||||t-test, 2 sided|Paired-sample t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.77
70858065|NCT04389970|141202283|OTHER|Single group, within subjects pre/post change.||||||0.66|||||||t-test, 2 sided|Paired-samples t-test.||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.66
70858066|NCT04389970|141202284|OTHER|Single group, within subjects pre/post change||||||0.88|||||||t-test, 2 sided|Paired samples t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.88
70858067|NCT04389970|141202285|OTHER|Single group, within subjects pre/post change||||||0.03|||||||t-test, 2 sided|Paired-samples t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.03
70858068|NCT04389970|141202286|OTHER|Single group, within subjects pre/post change.||||||0.06|||||||t-test, 2 sided|Paired samples t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.06
70858069|NCT04389970|141202287|OTHER|Single group, within subjects pre/post change||||||0.04|||||||t-test, 2 sided|Paired samples t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.04
70858070|NCT04389970|141202288|OTHER|Single group, within subjects analysis.||||||0|||||||t-test, 2 sided|Paired sample t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||0
71090107|NCT02065557|141686575|SUPERIORITY|one-sample two-sided Chi-square test||||||0.292||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.292
71127310|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.77|||||TWO_SIDED|95.0|-21.22|15.67|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||15.67|-21.22|
71127311|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-25.84|||||TWO_SIDED|95.0|-42.54|-9.14|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||-9.14|-42.54|
71127312|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-9.29|||||TWO_SIDED|95.0|-28.22|9.62|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||9.62|-28.22|
71127313|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|3.04|||||TWO_SIDED|95.0|-16.94|23.02|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||23.02|-16.94|
71127314|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|5.59|||||TWO_SIDED|95.0|-14.26|25.45|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||25.45|-14.26|
71127315|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-23.42|||||TWO_SIDED|95.0|-42.26|-4.59|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||-4.59|-42.26|
71127316|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-13.73|||||TWO_SIDED|95.0|-33.35|5.87|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||5.87|-33.35|
71127317|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|3.23|||||TWO_SIDED|95.0|-17.26|23.74|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||23.74|-17.26|
71127318|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-3.09|||||TWO_SIDED|95.0|-23.27|17.07|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||17.07|-23.27|
71127319|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-6.13|||||TWO_SIDED|95.0|-22.77|10.5|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||10.50|-22.77|
70858071|NCT01993836|141202336|OTHER||Spearman Correlation|-0.03|||||TWO_SIDED|95.0|-0.23|0.18||||||Correlation between 6-week change in Tau and continuous cognitive index||0.18|-0.23|
70858072|NCT01993836|141202336|OTHER||Spearman Correlation|-0.08|||||TWO_SIDED|95.0|-0.29|0.13||||||Correlation between 6-week change in Abeta and continuous cognitive index||0.13|-0.29|
70858073|NCT01993836|141202336|OTHER||Spearman Correlation|0.12|||||TWO_SIDED|95.0|-0.08|0.32||||||Correlation between 6-week change in P-Tau and continuous cognitive index||0.32|-0.08|
71127320|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.63|||||TWO_SIDED|95.0|-19.63|14.35|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||14.35|-19.63|
71127321|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.53|||||TWO_SIDED|95.0|-17.06|18.12|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||18.12|-17.06|
71127322|NCT01393639|141760262|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-6.89|||||TWO_SIDED|95.0|-23.24|9.46|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||9.46|-23.24|
71127323|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||0.00|0.00|
71127324|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.34|||||TWO_SIDED|95.0|-1.54|10.24|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||10.24|-1.54|
71127325|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|2.22|||||TWO_SIDED|95.0|-2.08|6.52|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||6.52|-2.08|
71127326|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|6.38|||||TWO_SIDED|95.0|-0.6|13.37|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||13.37|-0.60|
71127327|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|2.22|||||TWO_SIDED|95.0|-2.08|6.52|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||6.52|-2.08|
71127328|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.69|||||TWO_SIDED|95.0|0.55|16.83|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||16.83|0.55|
71127329|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||0.00|0.00|
70858074|NCT01993836|141202337|OTHER||Spearman Correlation|0.02|||||TWO_SIDED|95.0|-0.19|0.22||||||Correlation between 6-week change in Tau/Abeta ratio and continuous cognitive index||0.22|-0.19|
71127330|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.51|||||TWO_SIDED|95.0|0.53|16.48|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||16.48|0.53|
71127331|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|15.55|||||TWO_SIDED|95.0|4.96|26.14|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||26.14|4.96|
71127332|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|17.02|||||TWO_SIDED|95.0|6.27|27.76|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||27.76|6.27|
71127333|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.44|||||TWO_SIDED|95.0|-1.57|10.46|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||10.46|-1.57|
71127334|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|15.21|||||TWO_SIDED|95.0|4.83|25.59|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||25.59|4.83|
71127335|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.22|||||TWO_SIDED|95.0|-9.62|5.18|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||5.18|-9.62|
71127336|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.32|||||TWO_SIDED|95.0|-2.96|19.6|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||19.60|-2.96|
71127337|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.88|||||TWO_SIDED|95.0|-2.72|20.5|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||20.50|-2.72|
70858075|NCT01993836|141202337|OTHER||Spearman Correlation|0.16|||||TWO_SIDED|95.0|-0.05|0.34||||||Correlation between 6-week change in P-Tau/Abeta ratio and continuous cognitive index||0.34|-0.05|
71127338|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|12.57|||||TWO_SIDED|95.0|0.26|24.89|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||24.89|0.26|
71127339|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|2.22|||||TWO_SIDED|95.0|-7.23|11.67|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||11.67|-7.23|
71127340|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|17.29|||||TWO_SIDED|95.0|3.94|30.64|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||30.64|3.94|
71127341|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.22|||||TWO_SIDED|95.0|-14.6|10.16|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||10.16|-14.60|
71127342|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|5.91|||||TWO_SIDED|95.0|-8.22|20.04|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||20.04|-8.22|
71127343|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|15.55|||||TWO_SIDED|95.0|-0.29|31.4|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||31.40|-0.29|
71090108|NCT02065557|141686576|SUPERIORITY|one-sample two-sided Chi-square test||||||0.382||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.382
71090109|NCT02065557|141686576|SUPERIORITY|one-sample two-sided Chi-square test||||||1||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||1.000
71090110|NCT02065557|141686576|SUPERIORITY|one-sample two-sided Chi-square test||||||1||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||1.000
71090111|NCT02065557|141686576|SUPERIORITY|one-sample two-sided Chi-square test||||||0.344||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.344
71090112|NCT02065557|141686576|SUPERIORITY|one-sample two-sided Chi-square test||||||0.559||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.559
71090113|NCT02065557|141686576|SUPERIORITY|one-sample two-sided Chi-square test||||||0.815||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.815
71090114|NCT00250588|141686577|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.0||||0.05|TWO_SIDED|95.0|0.63|7.4||Bonferroni adjustment.|Mixed Models Analysis|Adjusted for child's age, race/ethnicity, Spanish, mother's education.||The primary effects of interest, condition and condition by time are fixed effects. PedsQL™ scores were analyzed as continuous normal outcomes with mixed effects regression models, which accounts for repeated measures over time for T2 and T3. Independent variables included baseline measure, time, asthma severity, condition, and condition by time interaction. We report the differences across groups in the adjusted mean changes over time.||7.4|0.63|0.05
71127344|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|10.16|||||TWO_SIDED|95.0|-4.7|25.03|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||25.03|-4.70|
71127345|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.44|||||TWO_SIDED|95.0|-16.16|7.27|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||7.27|-16.16|
71127346|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|14.97|||||TWO_SIDED|95.0|-0.68|30.63|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||30.63|-0.68|
70858076|NCT01993836|141202338|OTHER|||||||0.36|||||||t-test, 2 sided|||||||0.360
70858077|NCT01993836|141202339|OTHER|||||||0.532|||||||Wilcoxon (Mann-Whitney)|||Difference in 6-week Tau Change between anesthetic groups||||0.532
71127347|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||10.30|-10.30|
70858078|NCT01993836|141202339|OTHER|||||||0.565|||||||Wilcoxon (Mann-Whitney)|||Difference in 6-week Abeta Change between anesthetic groups||||0.565
70858079|NCT01993836|141202339|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Difference in 6-week P-Tau Change between anesthetic groups||||0.110
70858080|NCT01993836|141202340|OTHER|||||||0.439|||||||Wilcoxon (Mann-Whitney)|||Difference in 6-week Tau/Abeta ratio Change between anesthetic groups||||0.439
70858081|NCT01993836|141202340|OTHER|||||||0.082|||||||Wilcoxon (Mann-Whitney)|||Difference in 6-week P-Tau/Abeta Change between anesthetic groups||||0.082
70858082|NCT01993836|141202341|OTHER|||||||0.801|||||||Wilcoxon Signed Rank|||||||0.801
70858083|NCT04369924|141202351|SUPERIORITY||F test for time by condition interaction|1.49||||0.25|TWO_SIDED||||||ANOVA|||||||.25
70858084|NCT04369924|141202352|SUPERIORITY||F test for time by condition interaction|2.8||||0.12|TWO_SIDED||||||ANOVA|||||||.12
70858085|NCT04369924|141202353|SUPERIORITY||F test for time by condition interaction|0.7||||0.7|TWO_SIDED||||||ANOVA|||||||.70
70858086|NCT04369924|141202354|SUPERIORITY||F test for time by condition interaction|3.67||||0.07|TWO_SIDED||||||ANOVA|||||||.07
70858087|NCT04369924|141202355|SUPERIORITY||Slope|0.16||||0.82|TWO_SIDED||||||Mixed Models Analysis|||||||.82
70858088|NCT04369924|141202356|SUPERIORITY||Slope|-2.41||||0.59|TWO_SIDED||||||Mixed Models Analysis|||||||.59
70858089|NCT00708201|141202357|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.773|||<|0.0001|TWO_SIDED|95.0|1.359|2.311|||Wald's Chi-Square|||||2.311|1.359|<0.0001
70858090|NCT00708201|141202358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.7|||<|0.001|TWO_SIDED|95.0|-37.8|-11.5|||Log Rank|||||-11.5|-37.8|<0.001
70858091|NCT00708201|141202359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.4|||<|0.001|TWO_SIDED|95.0|-35.0|-9.9|||Log Rank|||||-9.9|-35.0|<0.001
70858092|NCT00708201|141202360|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
70858093|NCT00708201|141202361|SUPERIORITY_OR_OTHER||Relative Risk|1.38|||<|0.01|TWO_SIDED|95.0|1.12|1.71|||Fisher Exact||This is the relative risk for being a responder (alvimopan/placebo).|||1.71|1.12|<0.01
70858094|NCT00708201|141202362|SUPERIORITY_OR_OTHER||Percent difference|-20.71|||<|0.001|TWO_SIDED||||||Fisher Exact||Percent difference = alvimopan - placebo|Statistical analysis for overall POM is presented.||||<0.001
70858095|NCT00708201|141202363|SUPERIORITY_OR_OTHER||Percent difference|27.05|||<|0.0001|TWO_SIDED||||||Fisher Exact||Percent difference = alvimopan - placebo|Statistical analysis for day of surgery (Day 0) through PSD 7 is presented.||||<0.0001
70858096|NCT00708201|141202364|SUPERIORITY_OR_OTHER||Percent difference|25.2|||<|0.0001|TWO_SIDED||||||Fisher Exact||Percent difference = alvimopan - placebo|Statistical analysis for day of surgery (Day 0) through PSD 7 is presented.||||<0.0001
70858097|NCT00708201|141202365|SUPERIORITY_OR_OTHER||Percent difference|-6.94||||0.0946|TWO_SIDED|95.0|-14.5|0.62|||Fisher Exact||Percent difference = alvimopan - placebo.|||0.62|-14.5|0.0946
70858098|NCT00282464|141202366|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1||||0.0056
70858099|NCT00282464|141202366|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0866||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.0866
70858100|NCT00282464|141202366|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0568||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.0568
70858101|NCT00282464|141202366|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.0130
70946453|NCT00846768|141393218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.017||0.6578||95.0|-0.042|0.027|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.027|-0.042|0.6578
70946454|NCT00846768|141393218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.018||0.0175||95.0|0.008|0.077|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.077|0.008|0.0175
70858102|NCT00282464|141202366|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0188||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.0188
70858103|NCT00282464|141202366|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6394||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.6394
70858104|NCT00282464|141202366|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7707||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.7707
70858105|NCT00282464|141202367|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2185||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.2185
70858106|NCT00282464|141202367|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4124||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.4124
70946455|NCT00846768|141393219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.02||0.0353||95.0|-0.081|-0.003|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||-0.003|-0.081|0.0353
70946456|NCT00846768|141393219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.02||0.2875||95.0|-0.06|0.018|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.018|-0.060|0.2875
71127348|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|6.09|||||TWO_SIDED|95.0|-5.9|18.1|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||18.10|-5.90|
71127349|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||10.30|-10.30|
71127350|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.84|||||TWO_SIDED|95.0|-8.96|12.64|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||12.64|-8.96|
71127351|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.44|||||TWO_SIDED|95.0|-7.27|16.16|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||16.16|-7.27|
71127352|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.2|||||TWO_SIDED|95.0|-7.37|15.77|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||15.77|-7.37|
71127353|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-8.69|||||TWO_SIDED|95.0|-16.83|-0.55|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||-0.55|-16.83|
71127354|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.34|||||TWO_SIDED|95.0|-14.39|5.7|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||5.70|-14.39|
71127355|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-6.47|||||TWO_SIDED|95.0|-15.68|2.73|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||2.73|-15.68|
71127356|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.31|||||TWO_SIDED|95.0|-13.04|8.41|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||8.41|-13.04|
70946457|NCT00846768|141393219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.015|STANDARD_ERROR_OF_MEAN|0.02||0.4553||95.0|-0.024|0.054|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.054|-0.024|0.4553
70858107|NCT00282464|141202367|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6098||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.6098
71090115|NCT00250588|141686577|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.1||||0.05|TWO_SIDED|95.0|-0.21|6.4||Bonferroni adjustment|Mixed Models Analysis|Adjusted for child's age, race/ethnicity, Spanish, mother's education.||The primary effects of interest, condition and condition by time are fixed effects. PedsQL™ scores were analyzed as continuous normal outcomes with mixed effects regression models, which accounts for repeated measures over time for T2 and T3. Independent variables included baseline measure, time, asthma severity, condition, and condition by time interaction. We report the differences across groups in the adjusted mean changes over time.||6.4|-0.21|0.05
71090116|NCT00250588|141686578|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.21|TWO_SIDED|95.0|0.18|1.38|||Regression, Logistic|Adjustment for age, race/ethnicity, Spanish language and mother's education||||1.38|0.18|0.21
71090117|NCT00250588|141686578|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.85|TWO_SIDED|95.0|0.53|2.83||adjustment for age, race/ethnicity, Spanish language and mother's education|Regression, Logistic|||||2.83|0.53|0.85
71090118|NCT00250588|141686579|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.33||||0.011|TWO_SIDED|95.0|0.13|0.82|||Regression, Logistic|All analyses accounted for repeated measures and included the same terms in the model described previously.||Symptom frequency and utilization were analyzed using generalized linear mixed models (GLMM), with appropriate distribution and link functions. Nighttime symptoms is a dichotomous outcome and a logistic model was constructed.||0.82|0.13|0.011
71090119|NCT02330341|141686598|SUPERIORITY|||||||0.38||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of postprandial glucose on Artemisia Dracunculus group||||0.380
71090120|NCT02330341|141686598|SUPERIORITY|||||||0.695|||||||Wilcoxon (Mann-Whitney)|The threshold for statistical significance was p=0.05||Results showed in this section are the result of the differences between baseline and final values of postprandial glucose on placebo group||||0.695
71090121|NCT02330341|141686599|SUPERIORITY|||||||0.11||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of fasting glucose on Artemisia Dracunculus group||||0.110
71090122|NCT02330341|141686599|SUPERIORITY|||||||0.91||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of fasting glucose on placebo group||||0.910
71090123|NCT02330341|141686600|SUPERIORITY|||||||0.01||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of glucosylated hemoglobin on Artemisia Dracunculus group||||0.010
71090124|NCT02330341|141686600|SUPERIORITY|||||||0.938||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of glucosylated hemoglobin on placebo group||||0.938
71090125|NCT02330341|141686601|SUPERIORITY|||||||0.733||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of first phase of insulin secretion on Artemisia Dracunculus group||||0.733
71090126|NCT02330341|141686601|SUPERIORITY|||||||1||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of first phase of insulin secretion on placebo group||||1.0
71090127|NCT02330341|141686602|SUPERIORITY|||||||0.03||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total insulin secretion on Artemisia Dracunculus group||||0.03
71090128|NCT02330341|141686602|SUPERIORITY|||||||0.9||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total insulin secretion on placebo group||||0.900
71090129|NCT02330341|141686603|SUPERIORITY|||||||0.519||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of insulin sensitivity on Artemisia Dracunculus group||||0.519
71090130|NCT02330341|141686603|SUPERIORITY|||||||0.922||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of insulin sensitivity on placebo group||||0.922
71090131|NCT02330341|141686604|SUPERIORITY|||||||0.605||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of weight on Artemisia Dracunculus group||||0.605
70858108|NCT00282464|141202368|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1||||0.0005
70858109|NCT00282464|141202368|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0099||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.0099
70858110|NCT00282464|141202368|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0423||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.0423
70858111|NCT00282464|141202368|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0618||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.0618
70858112|NCT00282464|141202368|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0451||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.0451
70858113|NCT00282464|141202368|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2633||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.2633
70858114|NCT00282464|141202368|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2206||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.2206
70858115|NCT00282464|141202369|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9863||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.9863
70858116|NCT00282464|141202369|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1017||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.1017
70858117|NCT00282464|141202369|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4033||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.4033
70858118|NCT00282464|141202370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||||||No multiple comparison adjustment is applicable. Statistical significance level was 0.05|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.002
70858119|NCT00282464|141202370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.019
70858120|NCT00282464|141202370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.038
70858121|NCT00282464|141202370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.069|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.069
71127357|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-15.21|||||TWO_SIDED|95.0|-25.59|-4.83|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||-4.83|-25.59|
71127358|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-6.7|||||TWO_SIDED|95.0|-19.79|6.38|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||6.38|-19.79|
71127359|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.33|||||TWO_SIDED|95.0|-14.49|15.16|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||15.16|-14.49|
71127360|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.8|||||TWO_SIDED|95.0|-13.13|16.74|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||16.74|-13.13|
71127361|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-19.51|||||TWO_SIDED|95.0|-32.19|-6.84|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||-6.84|-32.19|
70858122|NCT00282464|141202370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.053|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.053
70858123|NCT00282464|141202370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.154|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6 An estimated sample size of 180 was needed per treatment arm in order to achieve 85% power to detect a treatment difference of 3.5 in the mean change from baseline to Week 6 in MADRS total score with a two-sided t-test at the 0.05 significance level. The common standard deviation was estimated as 11.0. The null hypotheses is equality of mean change from baseline to Week 6 in MADRS total score between ziprasidone and placebo groups.||||0.154
70858124|NCT00282464|141202370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.007
71127362|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-8.97|||||TWO_SIDED|95.0|-24.24|6.29|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||6.29|-24.24|
71127363|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-8.4|||||TWO_SIDED|95.0|-23.92|7.1|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||7.10|-23.92|
71127364|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.71|||||TWO_SIDED|95.0|-20.76|11.32|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||11.32|-20.76|
71127365|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-17.19|||||TWO_SIDED|95.0|-32.36|-2.02|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||-2.02|-32.36|
71127366|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-9.06|||||TWO_SIDED|95.0|-25.69|7.56|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||7.56|-25.69|
71127367|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.57|||||TWO_SIDED|95.0|-17.53|18.68|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||18.68|-17.53|
71127368|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.81|||||TWO_SIDED|95.0|-22.07|12.45|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||12.45|-22.07|
71127369|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.2|||||TWO_SIDED|95.0|-15.77|7.37|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||7.37|-15.77|
71127370|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.89|||||TWO_SIDED|95.0|-11.21|15.0|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||15.00|-11.21|
71127371|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.2|||||TWO_SIDED|95.0|-15.77|7.37|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||7.37|-15.77|
70858125|NCT00282464|141202371|SUPERIORITY_OR_OTHER_LEGACY|||||||0.112||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.112
71127372|NCT01393639|141760263|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.35|||||TWO_SIDED|95.0|-14.38|9.66|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||9.66|-14.38|
71127373|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.13|||||TWO_SIDED|95.0|-4.19|-0.07||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.07|-4.19|
71127374|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.6|||||TWO_SIDED|95.0|-5.63|-1.57||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.57|-5.63|
71127375|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.02|||||TWO_SIDED|95.0|-5.06|-0.97||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.97|-5.06|
71127376|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.7|||||TWO_SIDED|95.0|-5.73|-1.68||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.68|-5.73|
71127377|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.93|||||TWO_SIDED|95.0|-3.97|0.12||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.12|-3.97|
71127378|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.43|||||TWO_SIDED|95.0|-5.46|-1.39||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.39|-5.46|
71127379|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.81|||||TWO_SIDED|95.0|-4.03|0.42||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.42|-4.03|
71127380|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.83|||||TWO_SIDED|95.0|-5.04|-0.62||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.62|-5.04|
71127381|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.85|||||TWO_SIDED|95.0|-5.07|-0.64||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.64|-5.07|
71127382|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.77|||||TWO_SIDED|95.0|-4.98|-0.56||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.56|-4.98|
71127383|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.63|||||TWO_SIDED|95.0|-3.85|0.59||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.59|-3.85|
71127384|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.27|||||TWO_SIDED|95.0|-5.48|-1.06||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.06|-5.48|
71127385|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.23|||||TWO_SIDED|95.0|-4.66|0.2||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.20|-4.66|
71090132|NCT02330341|141686604|SUPERIORITY|||||||0.105||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of weight on placebo group||||0.105
71090133|NCT02330341|141686605|SUPERIORITY|||||||0.687||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of BMI on Artemisia Dracunculus group||||0.687
71090134|NCT02330341|141686605|SUPERIORITY|||||||0.021||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of BMI on placebo group||||0.021
71090135|NCT02330341|141686606|SUPERIORITY|||||||0.339||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total cholesterol on Artemisia Dracunculus group||||0.339
71090136|NCT02330341|141686606|SUPERIORITY|||||||0.246||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total cholesterol on placebo group||||0.246
71090137|NCT02330341|141686607|SUPERIORITY|||||||0.775||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of triglycerides on Artemisia Dracunculus group||||0.775
71090138|NCT02330341|141686607|SUPERIORITY|||||||0.195||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of triglycerides on placebo group||||0.195
71090139|NCT02330341|141686608|SUPERIORITY|||||||0.04||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of HDL-c on Artemisia Dracunculus group||||0.040
71127386|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.19|||||TWO_SIDED|95.0|-6.62|-1.77||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.77|-6.62|
71127387|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.73|||||TWO_SIDED|95.0|-6.15|-1.31||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.31|-6.15|
71127388|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.68|||||TWO_SIDED|95.0|-6.09|-1.26||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.26|-6.09|
71127389|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.27|||||TWO_SIDED|95.0|-4.69|0.16||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.16|-4.69|
71090140|NCT02330341|141686608|SUPERIORITY|||||||1||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of HDL-c on placebo group||||1.000
71090141|NCT02330341|141686609|SUPERIORITY|||||||0.021||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of ALT on Artemisia Dracunculus group||||0.021
71090142|NCT02330341|141686609|SUPERIORITY|||||||0.08||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of ALT on placebo group||||0.080
71090143|NCT02330341|141686610|SUPERIORITY|||||||0.465||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of AST on Artemisia Dracunculus group||||0.465
71127390|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.11|||||TWO_SIDED|95.0|-6.52|-1.7||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.70|-6.52|
71127391|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.8|||||TWO_SIDED|95.0|-5.34|-0.25||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.25|-5.34|
71127392|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.38|||||TWO_SIDED|95.0|-6.93|-1.83||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.83|-6.93|
71127393|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.2|||||TWO_SIDED|95.0|-7.74|-2.66||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.66|-7.74|
71090144|NCT02330341|141686610|SUPERIORITY|||||||0.574||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of AST on placebo group||||0.574
71090145|NCT02330341|141686611|SUPERIORITY|||||||0.48||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of creatinine on Artemisia Dracunculus group||||0.480
71090146|NCT02330341|141686611|SUPERIORITY|||||||0.383||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of creatinine on placebo group||||0.383
70858126|NCT00282464|141202371|SUPERIORITY_OR_OTHER_LEGACY|||||||0.352||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.352
71090147|NCT02330341|141686612|SUPERIORITY|||||||0.034||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of uric acid on Artemisia Dracunculus group||||0.034
71090148|NCT02330341|141686612|SUPERIORITY|||||||0.08||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of uric acid on placebo group||||0.080
71090149|NCT02330341|141686613|SUPERIORITY|||||||0.017||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of systolic blood pressure on Artemisia Dracunculus group||||0.017
71090150|NCT02330341|141686613|SUPERIORITY|||||||0.082||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of systolic blood pressure on placebo group||||0.082
71090151|NCT02330341|141686614|SUPERIORITY|||||||0.17||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of diastolic blood pressure on Artemisia Dracunculus group||||0.170
71090152|NCT02330341|141686614|SUPERIORITY|||||||0.199||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of diastolic blood pressure placebo group||||0.199
71090153|NCT02309359|141686644|OTHER|Under the assumption of monotonicity, a Cochran-Armitage trend test was performed as the primary efficacy analysis. Data were analyzed according to the intent-to-treat (ITT) principle; thus, subjects were analyzed according to the treatment to which they were assigned. Subjects with missing ACR20 response at Week 12 were treated as non responders (non responder imputation approach).||||||0.172|||||||Cochran-Armitage trend test|||The null hypothesis of this test was that there is no difference in the percentage of subjects achieving ACR20 response between the treatment groups and the alternative hypothesis was that the percentage of subjects achieving ACR20 response increases with increasing dose level.||||0.172
71090154|NCT00701363|141686672|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED||||||ANCOVA|||One subject (Group B) had missing IGF-1 value at Week 48. One subject (Group A) had missing IGF-1 value at Baseline.||||0.0013
71090155|NCT00701363|141686672|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71090156|NCT00701363|141686672|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71090157|NCT00701363|141686673|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED||||||t-test, 2 sided|||||||0.0009
71090158|NCT00701363|141686673|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71090159|NCT00701363|141686673|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71090160|NCT00701363|141686673|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED||||||t-test, 2 sided|||||||0.0170
71090161|NCT00701363|141686674|SUPERIORITY_OR_OTHER|||||||0.0103|TWO_SIDED||||||t-test, 2 sided|||Difference in baseline IGF-1 levels between 108 subjects with normalized IGF-1 levels at week 24 (A+B+C) and 14 subjects with uncontrolled IGF-1 levels at week 24.||||0.0103
71090162|NCT02783911|141686719|SUPERIORITY|||||||0.808|||||||Chi-squared|||||||0.808
71090163|NCT01041859|141686721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.234|<|0.001|TWO_SIDED|95.0|-1.415|-0.493||Analysis of covariance (ANCOVA) model was used with treatment, dose level, and pooled analysis center as factors and baseline pain intensity score as a covariate|ANCOVA||Mean Difference is least squares mean change in DB Tapentadol ER group minus least squares mean change in DB Placebo group (based on ANCOVA model)|The primary null hypothesis to be tested for the study was that the tapentadol ER group was not different from the placebo group for the primary endpoint. Assuming the mean treatment group difference of 1.0 with an SD of 2.6, 144 subjects per treatment group were estimated to provide 90% power to show that the tapentadol ER group was statistically different from placebo at an alpha level of 0.05. The total number of subjects to be randomly assigned to a DB treatment group for the study was 300.||-0.493|-1.415|<0.001
71090164|NCT00885118|141686733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42828.482|STANDARD_ERROR_OF_MEAN|6487.174|<|0.0001|TWO_SIDED|95.0|29936.586|55720.378|||ANCOVA|The baseline value was included as a continuous covariate.||Difference calculated as empa 1mg minus placebo||55720.378|29936.586|<0.0001
70858127|NCT00282464|141202371|SUPERIORITY_OR_OTHER_LEGACY|||||||0.873||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.873
70858128|NCT00282464|141202372|SUPERIORITY_OR_OTHER_LEGACY|||||||0.305||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.305
71090165|NCT00885118|141686733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|80964.677|STANDARD_ERROR_OF_MEAN|6303.82|<|0.0001|TWO_SIDED|95.0|68437.16|93492.194|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||93492.194|68437.160|<0.0001
71090166|NCT00885118|141686733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|88589.764|STANDARD_ERROR_OF_MEAN|6544.604|<|0.0001|TWO_SIDED|95.0|75583.738|101595.79|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||101595.790|75583.738|<0.0001
71090167|NCT00885118|141686733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|85620.348|STANDARD_ERROR_OF_MEAN|6610.091|<|0.0001|TWO_SIDED|95.0|72484.181|98756.515|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||98756.515|72484.181|<0.0001
71090168|NCT00885118|141686734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.68|STANDARD_ERROR_OF_MEAN|4.155||0.003|TWO_SIDED|95.0|-20.936|-4.424|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||-4.424|-20.936|0.0030
71090169|NCT00885118|141686734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.92|STANDARD_ERROR_OF_MEAN|4.025|<|0.0001|TWO_SIDED|95.0|-27.919|-11.921|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||-11.921|-27.919|<0.0001
70946458|NCT00846768|141393219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.02||0.2902||95.0|-0.06|0.018|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.018|-0.060|0.2902
70858129|NCT00282464|141202372|SUPERIORITY_OR_OTHER_LEGACY|||||||0.51||||||For all efficacy analyses, no multiple comparisons adjustments were made.|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.510
70858130|NCT00282464|141202372|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.710
70858131|NCT00282464|141202373|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.026
70858132|NCT00282464|141202373|SUPERIORITY_OR_OTHER_LEGACY|||||||0.223||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.223
70858133|NCT00282464|141202373|SUPERIORITY_OR_OTHER_LEGACY|||||||0.848||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.848
70858134|NCT00282464|141202374|SUPERIORITY_OR_OTHER_LEGACY|||||||0.381||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.381
70858135|NCT00282464|141202374|SUPERIORITY_OR_OTHER_LEGACY|||||||0.676||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.676
70858136|NCT00282464|141202374|SUPERIORITY_OR_OTHER_LEGACY|||||||0.295||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.295
70946459|NCT00846768|141393219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036|STANDARD_ERROR_OF_MEAN|0.02||0.0731||95.0|-0.003|0.075|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.075|-0.003|0.0731
71090170|NCT00885118|141686734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.208|STANDARD_ERROR_OF_MEAN|4.168|<|0.0001|TWO_SIDED|95.0|-34.49|-17.925|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-17.925|-34.490|<0.0001
70858137|NCT00282464|141202375|SUPERIORITY_OR_OTHER_LEGACY|||||||0.068||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.068
70858138|NCT00282464|141202375|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.043
71090171|NCT00885118|141686734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.235|STANDARD_ERROR_OF_MEAN|4.202|<|0.0001|TWO_SIDED|95.0|-35.586|-18.884|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-18.884|-35.586|<0.0001
70858139|NCT00282464|141202375|SUPERIORITY_OR_OTHER_LEGACY|||||||0.404||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.404
70858140|NCT00282464|141202376|SUPERIORITY_OR_OTHER_LEGACY|||||||0.899||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.899
70858141|NCT00282464|141202376|SUPERIORITY_OR_OTHER_LEGACY|||||||0.739||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.739
70858142|NCT00282464|141202376|SUPERIORITY_OR_OTHER_LEGACY|||||||0.797||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.797
70946460|NCT00846768|141393220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.027||0.0917||95.0|-0.008|0.099|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.099|-0.008|0.0917
71090172|NCT00885118|141686735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.883|STANDARD_ERROR_OF_MEAN|5.861||0.003|TWO_SIDED|95.0|-29.529|-6.236|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||-6.236|-29.529|0.0030
70858143|NCT00282464|141202377|SUPERIORITY_OR_OTHER_LEGACY|||||||0.434||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.434
70858144|NCT00282464|141202377|SUPERIORITY_OR_OTHER_LEGACY|||||||0.777||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.777
70858145|NCT00282464|141202377|SUPERIORITY_OR_OTHER_LEGACY|||||||0.82||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.820
70858146|NCT00282464|141202378|SUPERIORITY_OR_OTHER_LEGACY|||||||0.468||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.468
71090173|NCT00885118|141686735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.487|STANDARD_ERROR_OF_MEAN|5.445|<|0.0001|TWO_SIDED|95.0|-33.308|-11.665|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||-11.665|-33.308|<0.0001
70858147|NCT00282464|141202378|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.110
70858148|NCT00282464|141202378|SUPERIORITY_OR_OTHER_LEGACY|||||||0.738||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.738
70858149|NCT00282464|141202378|SUPERIORITY_OR_OTHER_LEGACY|||||||0.617||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.617
70858150|NCT00282464|141202378|SUPERIORITY_OR_OTHER_LEGACY|||||||0.642||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.642
70858151|NCT00282464|141202378|SUPERIORITY_OR_OTHER_LEGACY|||||||0.644||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.644
70946461|NCT00846768|141393220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.041|STANDARD_ERROR_OF_MEAN|0.027||0.1273||95.0|-0.012|0.095|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.095|-0.012|0.1273
70946462|NCT00846768|141393220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.027||0.008||95.0|0.019|0.127|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.127|0.019|0.0080
71090174|NCT00885118|141686735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.265|STANDARD_ERROR_OF_MEAN|5.785|<|0.0001|TWO_SIDED|95.0|-37.762|-14.768|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-14.768|-37.762|<0.0001
71090175|NCT00885118|141686735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.34|STANDARD_ERROR_OF_MEAN|5.699|<|0.0001|TWO_SIDED|95.0|-39.665|-17.015|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-17.015|-39.665|<0.0001
71090176|NCT00885118|141686736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.239|STANDARD_ERROR_OF_MEAN|0.13||0.0705|TWO_SIDED|95.0|-0.498|-0.02|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||-0.020|-0.498|0.0705
71090177|NCT00885118|141686736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.296|STANDARD_ERROR_OF_MEAN|0.125||0.0203|TWO_SIDED|95.0|-0.545|-0.047|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||-0.047|-0.545|0.0203
71090178|NCT00885118|141686736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.429|STANDARD_ERROR_OF_MEAN|0.13||0.0014|TWO_SIDED|95.0|-0.687|-0.17|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-0.170|-0.687|0.0014
71090179|NCT00885118|141686736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.395|STANDARD_ERROR_OF_MEAN|0.131||0.0033|TWO_SIDED|95.0|-0.654|-0.135|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-0.135|-0.654|0.0033
71090180|NCT00885118|141686737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.527|STANDARD_ERROR_OF_MEAN|17.755||0.4823|TWO_SIDED|95.0|-22.757|47.811|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||47.811|-22.757|0.4823
71127394|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9|||||TWO_SIDED|95.0|-7.43|-2.36||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.36|-7.43|
71127395|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.74|||||TWO_SIDED|95.0|-5.28|-0.2||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.20|-5.28|
71127396|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.57|||||TWO_SIDED|95.0|-7.1|-2.05||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.05|-7.10|
71127397|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-0.73|3.33||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.33|-0.73|
71127398|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|||||TWO_SIDED|95.0|-2.18|1.84||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.84|-2.18|
71127399|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.41|||||TWO_SIDED|95.0|-1.61|2.44||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.44|-1.61|
71127400|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.27|||||TWO_SIDED|95.0|-2.27|1.73||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.73|-2.27|
71090181|NCT00885118|141686737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.984|STANDARD_ERROR_OF_MEAN|17.313||0.7305|TWO_SIDED|95.0|-28.422|40.39|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||40.390|-28.422|0.7305
71090182|NCT00885118|141686737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.858|STANDARD_ERROR_OF_MEAN|17.903||0.3213|TWO_SIDED|95.0|-53.438|17.721|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||17.721|-53.438|0.3213
71090183|NCT00885118|141686737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.838|STANDARD_ERROR_OF_MEAN|18.13||0.2768|TWO_SIDED|95.0|-55.869|16.192|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||16.192|-55.869|0.2768
71090184|NCT00885118|141686738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.192|STANDARD_ERROR_OF_MEAN|0.728|<|0.0001|TWO_SIDED|95.0|-5.653|-2.731|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||-2.731|-5.653|<0.0001
71127401|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.47|||||TWO_SIDED|95.0|-0.74|3.68||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.68|-0.74|
71127402|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.45|||||TWO_SIDED|95.0|-1.76|2.65||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.65|-1.76|
71090185|NCT00885118|141686738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.609|STANDARD_ERROR_OF_MEAN|0.756|<|0.0001||95.0|-6.126|-3.091|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||-3.091|-6.126|<0.0001
71127403|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|||||TWO_SIDED|95.0|-1.79|2.63||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.63|-1.79|
71127404|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|||||TWO_SIDED|95.0|-1.69|2.7||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.70|-1.69|
71127405|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.88|||||TWO_SIDED|95.0|-0.53|4.29||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.29|-0.53|
71127406|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|||||TWO_SIDED|95.0|-2.5|2.33||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.33|-2.50|
71127407|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.38|||||TWO_SIDED|95.0|-2.03|2.79||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.79|-2.03|
71127408|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.43|||||TWO_SIDED|95.0|-1.97|2.84||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.84|-1.97|
71127409|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.78|||||TWO_SIDED|95.0|-0.75|4.3||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.30|-0.75|
71127410|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|||||TWO_SIDED|95.0|-2.34|2.73||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.73|-2.34|
71127411|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.62|||||TWO_SIDED|95.0|-3.14|1.89||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.89|-3.14|
71127412|NCT01393639|141760264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.33|||||TWO_SIDED|95.0|-2.84|2.19||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.19|-2.84|
71127413|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.18|||||TWO_SIDED|95.0|-2.91|0.56||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.56|-2.91|
71127414|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.45|||||TWO_SIDED|95.0|-4.17|-0.73||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.73|-4.17|
71127415|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.03|||||TWO_SIDED|95.0|-3.76|-0.29||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.29|-3.76|
71127416|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.11|||||TWO_SIDED|95.0|-4.82|-1.4||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.40|-4.82|
71127417|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-3.13|0.33||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.33|-3.13|
71127418|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.8|||||TWO_SIDED|95.0|-4.52|-1.07||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.07|-4.52|
70946463|NCT00846768|141393220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.027||0.8683||95.0|-0.049|0.058|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.058|-0.049|0.8683
70946464|NCT00846768|141393220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032|STANDARD_ERROR_OF_MEAN|0.027||0.2444||95.0|-0.022|0.086|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.086|-0.022|0.2444
70946465|NCT00846768|141393221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.099|STANDARD_ERROR_OF_MEAN|0.032||0.0023||95.0|-0.162|-0.036|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||-0.036|-0.162|0.0023
70946466|NCT00846768|141393221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.103|STANDARD_ERROR_OF_MEAN|0.032||0.0015||95.0|-0.165|-0.04|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||-0.040|-0.165|0.0015
70858152|NCT00282464|141202378|SUPERIORITY_OR_OTHER_LEGACY|||||||0.789||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.789
70858153|NCT00282464|141202379|SUPERIORITY_OR_OTHER_LEGACY|||||||0.042||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.042
70946467|NCT00846768|141393221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|0.032||0.4508||95.0|-0.087|0.039|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.039|-0.087|0.4508
70946468|NCT00846768|141393221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.032||0.9087||95.0|-0.059|0.066|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.066|-0.059|0.9087
70858154|NCT00282464|141202379|SUPERIORITY_OR_OTHER_LEGACY|||||||0.088||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.088
70858155|NCT00282464|141202379|SUPERIORITY_OR_OTHER_LEGACY|||||||0.651||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.651
71127419|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.67|||||TWO_SIDED|95.0|-3.63|0.29||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.29|-3.63|
71127420|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.98|||||TWO_SIDED|95.0|-3.94|-0.01||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.01|-3.94|
71127421|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.07|||||TWO_SIDED|95.0|-4.03|-0.11||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.11|-4.03|
71127422|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.13|||||TWO_SIDED|95.0|-5.09|-1.17||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.17|-5.09|
71127423|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.88|||||TWO_SIDED|95.0|-3.85|0.09||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.09|-3.85|
71127424|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.84|||||TWO_SIDED|95.0|-4.79|-0.88||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.88|-4.79|
71127425|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.32|||||TWO_SIDED|95.0|-3.25|0.6||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.60|-3.25|
71127426|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.97|||||TWO_SIDED|95.0|-3.9|-0.04||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.04|-3.90|
71127427|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.43|||||TWO_SIDED|95.0|-4.35|-0.5||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.50|-4.35|
71127428|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.75|||||TWO_SIDED|95.0|-4.66|-0.83||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.83|-4.66|
71127429|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.96|||||TWO_SIDED|95.0|-3.88|-0.03||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.03|-3.88|
71127430|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.08|||||TWO_SIDED|95.0|-5.0|-1.17||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.17|-5.00|
71127431|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.99|||||TWO_SIDED|95.0|-4.2|0.21||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.21|-4.20|
71127432|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.95|||||TWO_SIDED|95.0|-5.17|-0.72||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.72|-5.17|
71127433|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.44|||||TWO_SIDED|95.0|-5.65|-1.23||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.23|-5.65|
70858156|NCT00282464|141202379|SUPERIORITY_OR_OTHER_LEGACY|||||||0.665||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.665
70858157|NCT00282464|141202379|SUPERIORITY_OR_OTHER_LEGACY|||||||0.349||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.349
70858158|NCT00282464|141202379|SUPERIORITY_OR_OTHER_LEGACY|||||||0.685||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.685
71127434|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.32|||||TWO_SIDED|95.0|-5.52|-1.12||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.12|-5.52|
71127435|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.39|||||TWO_SIDED|95.0|-4.6|-0.18||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.18|-4.60|
71127436|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.87|||||TWO_SIDED|95.0|-6.07|-1.68||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.68|-6.07|
71127437|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.62|||||TWO_SIDED|95.0|-0.1|3.34||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.34|-0.10|
71127438|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|||||TWO_SIDED|95.0|-1.36|2.05||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.05|-1.36|
71127439|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.77|||||TWO_SIDED|95.0|-0.94|2.48||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.48|-0.94|
71127440|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|||||TWO_SIDED|95.0|-2.01|1.38||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.38|-2.01|
71127441|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.17|||||TWO_SIDED|95.0|-0.79|3.12||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.12|-0.79|
70858159|NCT00282464|141202379|SUPERIORITY_OR_OTHER_LEGACY|||||||0.257||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.257
71127442|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.86|||||TWO_SIDED|95.0|-1.1|2.82||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.82|-1.10|
71127443|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.76|||||TWO_SIDED|95.0|-1.19|2.72||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.72|-1.19|
70946469|NCT00846768|141393221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.032||0.0146||95.0|0.016|0.142|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.142|0.016|0.0146
71127444|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|||||TWO_SIDED|95.0|-2.24|1.66||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.66|-2.24|
71127445|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.76|||||TWO_SIDED|95.0|-0.16|3.67||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.67|-0.16|
71127446|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.12|||||TWO_SIDED|95.0|-0.81|3.04||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.04|-0.81|
70858160|NCT00282464|141202380|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0099||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Week 1||||0.0099
70858161|NCT00282464|141202380|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0654||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Week 2||||0.0654
70858162|NCT00282464|141202380|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1807||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Week 3||||0.1807
70858163|NCT00282464|141202380|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0957||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Week 4||||0.0957
71127447|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.66|||||TWO_SIDED|95.0|-1.26|2.57||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.57|-1.26|
71127448|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|||||TWO_SIDED|95.0|-1.57|2.25||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.25|-1.57|
71127449|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.88|||||TWO_SIDED|95.0|-0.31|4.07||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.07|-0.31|
71127450|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.93|||||TWO_SIDED|95.0|-1.28|3.13||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.13|-1.28|
71127451|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.43|||||TWO_SIDED|95.0|-1.76|2.62||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.62|-1.76|
71127452|NCT01393639|141760266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.55|||||TWO_SIDED|95.0|-1.63|2.74||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.74|-1.63|
71127453|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.49|||||TWO_SIDED|95.0|-12.52|3.55||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.55|-12.52|
71127454|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.15|||||TWO_SIDED|95.0|-18.1|-2.2||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.20|-18.10|
71127455|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.93|||||TWO_SIDED|95.0|-18.94|-2.92||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.92|-18.94|
71127456|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.12|||||TWO_SIDED|95.0|-24.01|-8.24||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-8.24|-24.01|
71127457|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.45|||||TWO_SIDED|95.0|-13.45|2.56||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.56|-13.45|
71127458|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.1|||||TWO_SIDED|95.0|-22.09|-6.11||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.11|-22.09|
71127459|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.42|||||TWO_SIDED|95.0|-11.13|4.29||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.29|-11.13|
71127460|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.98|||||TWO_SIDED|95.0|-15.7|-0.26||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.26|-15.70|
71127461|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.17|||||TWO_SIDED|95.0|-12.93|2.59||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.59|-12.93|
71127462|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.22|||||TWO_SIDED|95.0|-17.9|-2.54||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.54|-17.90|
71127463|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.43|||||TWO_SIDED|95.0|-5.32|10.19||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||10.19|-5.32|
71127464|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.14|||||TWO_SIDED|95.0|-18.83|-3.45||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.45|-18.83|
71127465|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.42|||||TWO_SIDED|95.0|-12.44|1.59||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.59|-12.44|
71127466|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.24|||||TWO_SIDED|95.0|-19.27|-5.2||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-5.20|-19.27|
71127467|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.13|||||TWO_SIDED|95.0|-16.11|-2.14||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.14|-16.11|
71127468|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.88|||||TWO_SIDED|95.0|-16.89|-2.88||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.88|-16.89|
71127469|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.61|||||TWO_SIDED|95.0|-9.63|4.4||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.40|-9.63|
71127470|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.93|||||TWO_SIDED|95.0|-19.88|-5.98||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-5.98|-19.88|
71127471|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1|||||TWO_SIDED|95.0|-10.03|3.83||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.83|-10.03|
71127472|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.1|||||TWO_SIDED|95.0|-17.06|-3.13||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.13|-17.06|
71127473|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.67|||||TWO_SIDED|95.0|-17.57|-3.77||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.77|-17.57|
71127474|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.79|||||TWO_SIDED|95.0|-14.72|-0.86||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.86|-14.72|
71127475|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.05|||||TWO_SIDED|95.0|-9.98|3.89||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.89|-9.98|
70858164|NCT00282464|141202380|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0752||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Week 5||||0.0752
71090186|NCT00885118|141686738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.036|STANDARD_ERROR_OF_MEAN|0.762|<|0.0001|TWO_SIDED|95.0|-5.565|-2.508|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-2.508|-5.565|<0.0001
71090187|NCT00885118|141686738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.887|STANDARD_ERROR_OF_MEAN|1.076|<|0.0001|TWO_SIDED|95.0|-7.048|-2.726|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-2.726|-7.048|<0.0001
71090188|NCT00885118|141686739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.414||0.2498|TWO_SIDED|95.0|-1.302|0.343|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||0.343|-1.302|0.2498
71090189|NCT00885118|141686739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.379|STANDARD_ERROR_OF_MEAN|0.408||0.3544|TWO_SIDED|95.0|-1.189|0.43|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||0.430|-1.189|0.3544
71090190|NCT00885118|141686739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.343|STANDARD_ERROR_OF_MEAN|0.416||0.0018|TWO_SIDED|95.0|-2.171|-0.516|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-0.516|-2.171|0.0018
71090191|NCT00885118|141686739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.257|STANDARD_ERROR_OF_MEAN|0.421||0.0037|TWO_SIDED|95.0|-2.094|-0.419|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-0.419|-2.094|0.0037
71090192|NCT00885118|141686740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-95.414|STANDARD_ERROR_OF_MEAN|15.388|<|0.0001|TWO_SIDED|95.0|-125.995|-64.833|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||-64.833|-125.995|<0.0001
71090193|NCT00885118|141686740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-109.48|STANDARD_ERROR_OF_MEAN|14.67|<|0.0001|TWO_SIDED|95.0|-138.633|-80.327|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||-80.327|-138.633|<0.0001
71090194|NCT00885118|141686740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-131.336|STANDARD_ERROR_OF_MEAN|15.354|<|0.0001|TWO_SIDED|95.0|-161.848|-100.824|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-100.824|-161.848|<0.0001
71090195|NCT00885118|141686740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-136.341|STANDARD_ERROR_OF_MEAN|15.357|<|0.0001|TWO_SIDED|95.0|-166.86|-105.823|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-105.823|-166.860|<0.0001
71090196|NCT00885118|141686741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.668|STANDARD_ERROR_OF_MEAN|13.152||0.0883|TWO_SIDED|95.0|-3.47|48.805|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||48.805|-3.470|0.0883
71090197|NCT00885118|141686741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.576|STANDARD_ERROR_OF_MEAN|12.941||0.0203|TWO_SIDED|95.0|4.859|56.293|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||56.293|4.859|0.0203
71090198|NCT00885118|141686741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.974|STANDARD_ERROR_OF_MEAN|13.289||0.6541|TWO_SIDED|95.0|-20.434|32.382|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||32.382|-20.434|0.6541
71090199|NCT00885118|141686741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.015|STANDARD_ERROR_OF_MEAN|13.612||0.4206|TWO_SIDED|95.0|-16.036|38.066|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||38.066|-16.036|0.4206
71090200|NCT00885118|141686742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.869|STANDARD_ERROR_OF_MEAN|4.066||0.0318|TWO_SIDED|95.0|-16.949|-0.789|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||-0.789|-16.949|0.0318
71090201|NCT00885118|141686742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.344|STANDARD_ERROR_OF_MEAN|3.966||0.0005|TWO_SIDED|95.0|-22.225|-6.462|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||-6.462|-22.225|0.0005
71090202|NCT00885118|141686742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.642|STANDARD_ERROR_OF_MEAN|4.131||0.0003|TWO_SIDED|95.0|-23.853|-7.432|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-7.432|-23.853|0.0003
71090203|NCT00885118|141686742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.118|STANDARD_ERROR_OF_MEAN|4.137||0.0164|TWO_SIDED|95.0|-18.339|-1.897|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-1.897|-18.339|0.0164
71090204|NCT05471505|141686780|OTHER||Hazard Ratio (HR)|0.752|||<|0.001|TWO_SIDED|95.0|0.719|0.787|||COX Proportional Hazards Regression|||||0.787|0.719|<0.001
71090205|NCT05471505|141686781|OTHER||Hazard Ratio (HR)|0.747|||<|0.001|TWO_SIDED|95.0|0.687|0.813|||COX Proportional Hazards Regression|||||0.813|0.687|<0.001
71090206|NCT05471505|141686782|OTHER||Hazard Ratio (HR)|0.909|||<|0.001|TWO_SIDED|95.0|0.862|0.958|||COX Proportional Hazards Regression|||||0.958|0.862|<0.001
70858165|NCT00282464|141202380|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3964||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Week 6||||0.3964
71090207|NCT05471505|141686783|OTHER||Hazard Ratio (HR)|0.948||||0.378|TWO_SIDED|95.0|0.842|1.067|||COX Proportional Hazards Regression|||||1.067|0.842|0.378
71090208|NCT05471505|141686784|OTHER||Hazard Ratio (HR)|0.259|||<|0.001|TWO_SIDED|95.0|0.229|0.294|||COX Proportional Hazards Regression|||||0.294|0.229|<0.001
71090209|NCT05471505|141686785|OTHER||Hazard Ratio (HR)|0.767|||<|0.001|TWO_SIDED|95.0|0.7|0.84|||COX Proportional Hazards Regression|||||0.840|0.700|<0.001
71090210|NCT05471505|141686786|OTHER||Hazard Ratio (HR)|0.932||||0.022|TWO_SIDED|95.0|0.877|0.99|||COX Proportional Hazards Regression|||||0.990|0.877|0.022
71090211|NCT00315341|141686802|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||shift table analyses|||categorized changes in ALT/AST from BL:(1)BL transaminases(both ALT/AST)≤2X upper limit of normal(ULN)\& remained at this level;(2)BL transaminases ≤2X ULN(either ALT/AST)but increased(either ALT/AST)above this level at any time;(3)BL transaminases \>2X ULN(either ALT/AST)\& decreased and remained at ≤2X ULN(both ALT/AST);(4)BL transaminases(both ALT/AST)\>2X ULN \&remained at this level(both ALT/AST);(5)BL transaminases \>2X ULN(either ALT/AST)\& increased 2X above this level ever(either ALT/AST).||||< 0.05
71127476|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.41|||||TWO_SIDED|95.0|-20.27|-6.54||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.54|-20.27|
71127477|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.61|||||TWO_SIDED|95.0|1.62|17.61||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||17.61|1.62|
71127478|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.95|||||TWO_SIDED|95.0|-3.96|11.85||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||11.85|-3.96|
70858166|NCT00282464|141202380|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0287||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Overall||||0.0287
71090212|NCT01075048|141686812|SUPERIORITY|||||||0.3815|||||||Log Rank|||||||0.3815
71090213|NCT01075048|141686812|SUPERIORITY|||||||0.19|||||||Peto-Peto-Prentice|||||||0.1900
71090214|NCT01075048|141686812|SUPERIORITY|||||||0.1986|||||||Generalized Wilcoxon|||||||0.1986
71090215|NCT01075048|141686812|SUPERIORITY|||||||0.2617|||||||Tarone-Ware|||||||0.2617
71090216|NCT01075048|141686813|SUPERIORITY|||||||0.4488|||||||Log Rank|||||||0.4488
71090217|NCT01075048|141686813|SUPERIORITY|||||||0.2887|||||||Peto-Peto-Prentice|||||||0.2887
71090218|NCT01075048|141686813|SUPERIORITY|||||||0.1851|||||||Generalized Wilcoxon|||||||0.1851
71090219|NCT01075048|141686813|SUPERIORITY|||||||0.2495|||||||Tarone-Ware|||||||0.2495
71127479|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.17|||||TWO_SIDED|95.0|-4.8|11.13||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||11.13|-4.80|
71127480|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.03|||||TWO_SIDED|95.0|-9.86|5.81||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.81|-9.86|
71127481|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.72|||||TWO_SIDED|95.0|0.03|15.42||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||15.42|0.03|
71127482|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.16|||||TWO_SIDED|95.0|-4.54|10.87||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||10.87|-4.54|
70858167|NCT00282464|141202381|SUPERIORITY_OR_OTHER_LEGACY|||||||0.965||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Change from baseline to endpoint||||0.965
71090220|NCT01075048|141686815|SUPERIORITY|||||||0.2804|||||||Log Rank|||OS data cutoff as of 12 Oct 2012||||0.2804
71090221|NCT01075048|141686815|SUPERIORITY|||||||0.2469|||||||Log Rank|||OS data cutoff as of 29 Mar 2013||||0.2469
71127483|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.97|||||TWO_SIDED|95.0|-1.77|13.71||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||13.71|-1.77|
71090222|NCT01075048|141686815|SUPERIORITY|||||||0.1334|||||||Log Rank|||OS data cutoff as of 25 Jul 2013||||0.1334
71090223|NCT01075048|141686815|SUPERIORITY|||||||0.2159|||||||Log Rank|||OS data cutoff as of 20 Feb 2015||||0.2159
71090224|NCT04596293|141686819|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71090225|NCT04596293|141686819|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71090226|NCT04596293|141686820|OTHER|||||||0.6351|||||||Fisher Exact|||||||0.6351
71090227|NCT04596293|141686820|OTHER|||||||0.3108|||||||Fisher Exact|||||||0.3108
71090228|NCT04596293|141686821|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71090229|NCT04596293|141686821|OTHER|||||||0.6594|||||||Fisher Exact|||||||0.6594
71090230|NCT04596293|141686822|OTHER|||||||0.5808|||||||ANCOVA|||||||0.5808
71090231|NCT04596293|141686822|OTHER|||||||0.2143|||||||ANCOVA|||||||0.2143
71090232|NCT01287936|141686824|SUPERIORITY||||||<|0.001|||||||Wilcoxon Signed Rank test|||||||<0.001
71090233|NCT01287936|141686826|SUPERIORITY|||||||0.004|||||||Wilcoxon Signed Rank test|||||||0.004
71127484|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.92|||||TWO_SIDED|95.0|-6.75|8.59||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.59|-6.75|
71127485|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.5|||||TWO_SIDED|95.0|0.57|14.43||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||14.43|0.57|
71127486|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.69|||||TWO_SIDED|95.0|-6.26|7.64||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.64|-6.26|
71127487|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.8|||||TWO_SIDED|95.0|-3.09|10.7||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||10.70|-3.09|
71127488|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.05|||||TWO_SIDED|95.0|-3.87|9.96||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.96|-3.87|
71127489|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.31|||||TWO_SIDED|95.0|3.43|17.18||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||17.18|3.43|
71127490|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.31|||||TWO_SIDED|95.0|-3.59|10.22||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||10.22|-3.59|
71127491|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.73|||||TWO_SIDED|95.0|-4.1|9.57||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.57|-4.10|
70946470|NCT00846768|141393222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.027|STANDARD_ERROR_OF_MEAN|0.027||0.3291||95.0|-0.08|0.027|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.027|-0.080|0.3291
70858168|NCT00282464|141202382|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Change from baseline to endpoint||||0.860
70858169|NCT00282464|141202383|SUPERIORITY_OR_OTHER_LEGACY|||||||0.428||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Baseline to endpoint||||0.428
71090234|NCT00336544|141686839|NON_INFERIORITY_OR_EQUIVALENCE|Delta will be determined by the highest clinical cure-rate between the Cethromycin treatment group and the Clarithromycin treatment group, as follows: Greater than or equal to 90%, delta = -10%; Greater than or equal to 80% and less than 90%, delta = -15%, Greater than or equal to 70% and less than 80%, -20%)|Mean Difference (Net)|-5.7||||0.0769||95.0|-11.9|0.6|||Fisher Exact|||The rate of clinical cure in each treatment group was calculated (number of cures/number of patient eligible for analysis). Non-inferiority will be demonstrated when the lower limit of the two-sided 95% confidence interval for the difference in the clinical cure rate at the Test-of-Cure visit between treatment groups (Cethromycin -Clarithromycin) is greater than delta, and includes zero, for both Per-Protocol (PP) and Intent-to-Treat (ITT) analyses.||0.6|-11.9|0.0769
71090235|NCT00336544|141686841|NON_INFERIORITY_OR_EQUIVALENCE|Delta will be determined by the highest clinical cure-rate between the Cethromycin treatment group and the Clarithromycin treatment group, as follows: Greater than or equal to 90%, delta = -10%; Greater than or equal to 80% and less than 90%, delta = -15%, Greater than or equal to 70% and less than 80%, -20%)|Mean Difference (Net)|-4.4||||0.0775||95.0|-9.1|0.3|||Fisher Exact|||The rate of clinical cure in each treatment group was calculated (number of cures/number of patient eligible for analysis). Non-inferiority will be demonstrated when the lower limit of the two-sided 95% confidence interval for the difference in the clinical cure rate at the Test-of-Cure visit between treatment groups (Cethromycin -Clarithromycin) is greater than delta, and includes zero, for both Per-Protocol (PP) and Intent-to-Treat (ITT) analyses.||0.3|-9.1|0.0775
71090236|NCT01649765|141686843|SUPERIORITY||Odds Ratio (OR)|1.49|||||TWO_SIDED|95.0|0.64|3.46||||||||3.46|0.64|
71090237|NCT01649765|141686844|SUPERIORITY||Odds Ratio (OR)|2.74|||||TWO_SIDED|95.0|1.15|6.54|||||Definition 1|||6.54|1.15|
71090238|NCT01649765|141686844|SUPERIORITY||Odds Ratio (OR)|2.92|||||TWO_SIDED|95.0|1.19|7.17|||||Definition 2|||7.17|1.19|
71090239|NCT03427411|141686882|NON_INFERIORITY|Non-inferiority was defined as response rates which were sufficiently similar (p\>0.20 by Fisher's exact test).||||||0.6143||||||The p value was calculated and was 0.6143 which is \> 0.2 (pre-defined threshold).|Fisher Exact|||||||0.6143
71090240|NCT02058095|141686908|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
71090241|NCT02058095|141686910|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
71090242|NCT00148798|141686915|SUPERIORITY_OR_OTHER|||||||0.0441|TWO_SIDED|95.0|||||Stratified Log Rank|||Primary efficacy analysis: To test equality of OS time between treatment groups, applying the two-sided stratified log-rank test (Stage IIIb vs IV, ECOG 0/1 vs 2) (α=5%).||||0.0441
71090243|NCT00148798|141686916|SUPERIORITY_OR_OTHER|||||||0.3869|TWO_SIDED|95.0|||||Stratified Log Rank|||To test equality of progression free survival time between treatment groups, applying the two-sided stratified log-rank test (α=5%).||||0.3869
71090244|NCT00148798|141686917|SUPERIORITY_OR_OTHER|||||||0.0101|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||The best overall response rate was compared in the Cochran-Mantel-Haenszel test (two-sided with α=5%).||||0.0101
71090245|NCT00148798|141686918|SUPERIORITY_OR_OTHER|||||||0.6801|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||The disease control rate was compared in the Cochran-Mantel-Haenszel test (two-sided with α=5%).||||0.6801
71090246|NCT00316004|141686923|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent prevalence of poor outcome between the three groups.||||0.55
71090247|NCT00316004|141686924|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|Adjusted for multiple imputations||The null hypothesis is that there are no differences in the percent prevalence of poor outcome between the three treatment groups among patients with head AIS≥4.||||0.59
71090248|NCT00316004|141686925|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|Adjusted for multiple imputations.||The null hypothesis is that there are no differences in the percent prevalence of poor outcome between the three groups.||||0.67
71090249|NCT00316004|141686926|SUPERIORITY_OR_OTHER|||||||0.57||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|Adjusted for multiple imputations||The null hypothesis is that there are no differences in the percent prevalence of poor outcome between the three treatment groups among patients with head AIS≥2.||||0.57
71127492|NCT01393639|141760268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.62|||||TWO_SIDED|95.0|-1.25|12.48||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||12.48|-1.25|
70858170|NCT00282464|141202384|SUPERIORITY_OR_OTHER_LEGACY|||||||0.708||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANOVA|ANOVA model included effects of treatment, rapid cycling, center and prior hospitalization status||Change from baseline to endpoint||||0.708
70858171|NCT00282464|141202385|SUPERIORITY_OR_OTHER_LEGACY|||||||0.898||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.898
70858172|NCT00282464|141202386|SUPERIORITY_OR_OTHER_LEGACY|||||||0.559||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANOVA|ANOVA model included effects of treatment, rapid cycling, center and prior hospitalization status.||Endpoint||||0.559
71090250|NCT00316004|141686927|SUPERIORITY_OR_OTHER|||||||0.84||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for proportions|Adjusted for multiple imputations||The null hypothesis is that there are no differences in the percent of patients at any level of disability between the three groups.||||.84
71090251|NCT00316004|141686928|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the percent of patients who were alive on the 28th day after injury between the three groups.||||0.88
71090252|NCT00316004|141686929|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the percent of patients who were alive on the day discharged from the hospital after injury between the three groups.||||0.88
71090253|NCT00316004|141686930|SUPERIORITY_OR_OTHER|||||||0.91||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the percent of patients who were alive and free of ARDS from the day of injury to the 28th day after injury between the three groups.||||0.91
71090254|NCT00316004|141686931|SUPERIORITY_OR_OTHER|||||||0.81||95.0||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in average Worst Multiple Organ Dysfunction Scores (MODS) through day 28 between the three groups.||||0.81
71127493|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.38|||||TWO_SIDED|95.0|-7.56|8.31||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.31|-7.56|
71127494|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.15|||||TWO_SIDED|95.0|-16.01|-0.3||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.30|-16.01|
71127495|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.1|||||TWO_SIDED|95.0|-22.01|-6.2||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.20|-22.01|
71127496|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.88|||||TWO_SIDED|95.0|-19.7|-4.06||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.06|-19.70|
71127497|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.58|||||TWO_SIDED|95.0|-7.33|8.48||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.48|-7.33|
71127498|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.89|||||TWO_SIDED|95.0|-20.8|-4.98||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.98|-20.80|
71127499|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|||||TWO_SIDED|95.0|-9.31|8.58||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.58|-9.31|
70858173|NCT00282464|141202387|SUPERIORITY_OR_OTHER_LEGACY|||||||0.458||||||For all secondary efficacy analyses, no multiple adjustments were made|ANOVA|ANVOVA model included effects of treatment, rapid cycling, center and prior hospitalization status.||Endpoint||||0.458
71127500|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.48|||||TWO_SIDED|95.0|-18.43|-0.53||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.53|-18.43|
71127501|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.42|||||TWO_SIDED|95.0|-22.39|-4.44||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.44|-22.39|
71127502|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.58|||||TWO_SIDED|95.0|-17.48|0.33||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.33|-17.48|
71090255|NCT00316004|141686932|SUPERIORITY_OR_OTHER|||||||0.77||95.0||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the average number of Ventilator-free days through day 28 between the three groups.||||0.77
71090256|NCT00316004|141686933|SUPERIORITY_OR_OTHER|||||||0.76||95.0||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the average number of days alive out of the ICU through day 28 between the three groups.||||0.76
71090257|NCT00316004|141686934|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the average number of days alive out of the hospital through day 28 between the three groups.||||0.43
71127503|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.6|||||TWO_SIDED|95.0|-11.57|6.38||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||6.38|-11.57|
71127504|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.75|||||TWO_SIDED|95.0|-22.73|-4.78||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.78|-22.73|
71127505|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22|||||TWO_SIDED|95.0|-9.32|8.88||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.88|-9.32|
71127506|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.28|||||TWO_SIDED|95.0|-21.39|-3.17||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.17|-21.39|
71127507|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.44|||||TWO_SIDED|95.0|-25.53|-7.36||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-7.36|-25.53|
70858174|NCT02360605|141202398|SUPERIORITY|||||||0.61||||||p-values control for age (in years), race (African American vs Caucasian and Hispanic), gender, and literacy (2 categories) The a priori threshold for statistical significance was p\<0.05|Mixed Models Analysis|||FIT completion rates were defined as the percentage of FIT tests returned. Screening ratios were defined as the PC to AC ratio of FIT completion rates. Multivariate analyses adjusting for age, race, gender, and literacy level were done using generalized linear models. Multivariate analyses adjusting for age, race, gender, and literacy level were done using generalized linear models. A test for interaction between literacy level and study arm were assessed.||||0.61
70946471|NCT00846768|141393222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.027||0.2638||95.0|-0.084|0.023|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.023|-0.084|0.2638
71090258|NCT00316004|141686935|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients with any nosocomial infections through hospital stay between the three groups.||||0.06
71127508|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.38|||||TWO_SIDED|95.0|-18.42|-0.34||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.34|-18.42|
71127509|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.52|||||TWO_SIDED|95.0|-13.61|4.57||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.57|-13.61|
71127510|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.78|||||TWO_SIDED|95.0|-22.87|-4.69||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.69|-22.87|
71127511|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.85|||||TWO_SIDED|95.0|-7.9|11.6||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||11.60|-7.90|
71127512|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.72|||||TWO_SIDED|95.0|-20.51|-0.93||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.93|-20.51|
71127513|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.52|||||TWO_SIDED|95.0|-28.28|-8.77||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-8.77|-28.28|
71127514|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.96|||||TWO_SIDED|95.0|-22.67|-3.25||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.25|-22.67|
71127515|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.46|||||TWO_SIDED|95.0|-17.21|2.3||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.30|-17.21|
71127516|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.24|||||TWO_SIDED|95.0|-26.0|-6.48||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.48|-26.00|
71127517|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.27|||||TWO_SIDED|95.0|5.34|21.2||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||21.20|5.34|
71127518|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.74|||||TWO_SIDED|95.0|-3.12|12.59||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||12.59|-3.12|
71127519|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.21|||||TWO_SIDED|95.0|-9.1|6.68||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||6.68|-9.10|
71127520|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.01|||||TWO_SIDED|95.0|-6.79|8.81||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.81|-6.79|
71127521|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.39|||||TWO_SIDED|95.0|4.39|22.38||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||22.38|4.39|
71127522|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.27|||||TWO_SIDED|95.0|-4.73|13.27||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||13.27|-4.73|
71127523|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|||||TWO_SIDED|95.0|-8.68|9.35||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.35|-8.68|
71127524|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.18|||||TWO_SIDED|95.0|-3.77|14.12||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||14.12|-3.77|
71127525|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.56|||||TWO_SIDED|95.0|4.44|22.68||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||22.68|4.44|
71090259|NCT00316004|141686935|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients with pneumonia through hospital stay between the three groups.||||0.3
71090260|NCT00316004|141686935|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients with bloodstream infections through hospital stay between the three groups.||||0.04
71090261|NCT00316004|141686935|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients with urinary tract infections through hospital stay between the three groups.||||0.06
71090262|NCT00316004|141686935|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients with wound infections through hospital stay between the three groups.||||0.88
71090263|NCT00316004|141686936|SUPERIORITY_OR_OTHER|||||||0.68||95.0||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|||The null hypothesis is that there are no differences in the average amount of total fluids given within the first 24 hours between the three groups.||||0.68
71090264|NCT00316004|141686937|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|||The null hypothesis is that there are no differences in the average number of PRBC units given within the first 24 hours between the three groups.||||0.43
70872040|NCT01652703|141229480|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-20.82|STANDARD_ERROR_OF_MEAN|9.41||0.028|TWO_SIDED|95.0|-39.41|-2.22||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-2.22|-39.41|0.028
71090265|NCT00316004|141686938|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died during hospitalization between the three groups.||||0.88
71090266|NCT00316004|141686938|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients who were discharged alive from the hospital to home between the three groups.||||0.26
71090267|NCT00316004|141686938|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients who were discharged alive from the hospital to inpatient rehabilitation facilities between the three groups.||||0.16
71090268|NCT00316004|141686938|SUPERIORITY_OR_OTHER|||||||0.17||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients who were discharged alive from the hospital to skilled nursing facilities between the three groups.||||0.17
71090269|NCT02202252|141686939|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.490
71090270|NCT02202252|141686940|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||Chi-squared|||||||0.035
71090271|NCT02202252|141686941|SUPERIORITY_OR_OTHER|||||||0.819|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.819
70946472|NCT00846768|141393222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026|STANDARD_ERROR_OF_MEAN|0.027||0.3386||95.0|-0.028|0.08|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.080|-0.028|0.3386
71090272|NCT00977197|141686942|SUPERIORITY_OR_OTHER|||||||0.008|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender.||||||0.008
71090273|NCT00977197|141686943|SUPERIORITY_OR_OTHER|||||||0.009|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender.||||||0.009
71090274|NCT00977197|141686944|SUPERIORITY_OR_OTHER|||||||0.389|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender; rank scale.||||||0.389
71090275|NCT00977197|141686945|SUPERIORITY_OR_OTHER|||||||0.049|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender, rank scale.||||||0.049
71090276|NCT00977197|141686946|SUPERIORITY_OR_OTHER|||||||0.044|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender.||||||0.044
71127526|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.5|||||TWO_SIDED|95.0|-7.64|10.64||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||10.64|-7.64|
71127527|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.66|||||TWO_SIDED|95.0|-11.76|6.44||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||6.44|-11.76|
71127528|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.41|||||TWO_SIDED|95.0|-4.65|13.46||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||13.46|-4.65|
71127529|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.09|||||TWO_SIDED|95.0|8.34|27.84||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||27.84|8.34|
71127530|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.52|||||TWO_SIDED|95.0|-4.27|15.32||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||15.32|-4.27|
71127531|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.28|||||TWO_SIDED|95.0|-12.03|7.46||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.46|-12.03|
71127532|NCT01393639|141760270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.28|||||TWO_SIDED|95.0|-6.42|12.98||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||12.98|-6.42|
71127533|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.06|||||TWO_SIDED|95.0|-14.07|-0.06||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.06|-14.07|
71127534|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.45|||||TWO_SIDED|95.0|-19.34|-5.56||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-5.56|-19.34|
71127535|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.85|||||TWO_SIDED|95.0|-19.79|-5.91||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-5.91|-19.79|
71127536|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.92|||||TWO_SIDED|95.0|-22.79|-9.06||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-9.06|-22.79|
71090277|NCT00977197|141686947|SUPERIORITY_OR_OTHER|||||||0.35||||||Intent to treat analysis, not adjusted for age and gender.|Chi-squared|||||||0.350
71090278|NCT00977197|141686948|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender, rank scale.||||||0.020
71090279|NCT00977197|141686949|SUPERIORITY_OR_OTHER|||||||0.024|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender.||||||0.024
71090280|NCT00977197|141686950|SUPERIORITY_OR_OTHER|||||||0.417|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender, rank scale.||||||0.417
71090281|NCT00977197|141686951|SUPERIORITY_OR_OTHER|||||||0.03||||||Intent to Treat analysis; adjusted for age and gender, rank scale.|ANCOVA|||||||0.030
71090282|NCT00977197|141686952|SUPERIORITY_OR_OTHER|||||||0.016|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender.||||||0.016
71090283|NCT00977197|141686953|SUPERIORITY_OR_OTHER|||||||0.097||||||Intent to Treat analysis; not adjusted for age and gender.|Chi-squared|||||||0.097
70946473|NCT00846768|141393222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.027||0.8877||95.0|-0.05|0.057|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.057|-0.050|0.8877
71127537|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.95|||||TWO_SIDED|95.0|-10.89|2.99||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.99|-10.89|
71127538|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.51|||||TWO_SIDED|95.0|-20.44|-6.57||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.57|-20.44|
71127539|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.25|||||TWO_SIDED|95.0|-14.65|0.16||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.16|-14.65|
71127540|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.03|||||TWO_SIDED|95.0|-19.38|-4.68||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.68|-19.38|
71127541|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.72|||||TWO_SIDED|95.0|-23.1|-8.35||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-8.35|-23.10|
71127542|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.95|||||TWO_SIDED|95.0|-21.27|-6.63||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.63|-21.27|
71127543|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.94|||||TWO_SIDED|95.0|-13.31|1.43||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.43|-13.31|
71127544|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.16|||||TWO_SIDED|95.0|-23.54|-8.79||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-8.79|-23.54|
71127545|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.09|||||TWO_SIDED|95.0|-13.5|1.32||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.32|-13.50|
71127546|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.06|||||TWO_SIDED|95.0|-20.46|-5.65||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-5.65|-20.46|
71127547|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.31|||||TWO_SIDED|95.0|-22.69|-7.93||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-7.93|-22.69|
70946474|NCT00846768|141393222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.027||0.0402||95.0|0.003|0.111|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.111|0.003|0.0402
71127548|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.31|||||TWO_SIDED|95.0|-20.66|-5.96||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-5.96|-20.66|
71127549|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.06|||||TWO_SIDED|95.0|-16.44|-1.68||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.68|-16.44|
71127550|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.44|||||TWO_SIDED|95.0|-21.82|-7.06||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-7.06|-21.82|
71127551|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.72|||||TWO_SIDED|95.0|-12.53|3.09||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.09|-12.53|
70858175|NCT02360605|141202399|SUPERIORITY|||||||0.3||||||p-values control for age (in years), race (African American vs Caucasian and Hispanic), gender, and literacy (2 categories) The a priori threshold for statistical significance was p\<0.05|Mixed Models Analysis|||Multivariate analyses adjusting for age, race, gender, and health literacy level were done using generalized linear models. A test for interaction between study arm and each of literacy level, age, gender and race was performed to determine whether treatment effect differed by levels of these factors. An unadjusted test for the main effect of each of health literacy level, age, gender, race and study arm was performed to determine whether screening rates differed by levels of these factors.||||0.30
71127552|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.4|||||TWO_SIDED|95.0|-20.21|-4.59||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.59|-20.21|
71127553|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.48|||||TWO_SIDED|95.0|-24.25|-8.71||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-8.71|-24.25|
71127554|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.19|||||TWO_SIDED|95.0|-19.94|-4.44||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.44|-19.94|
70872041|NCT01652703|141229481|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-46.98|STANDARD_ERROR_OF_MEAN|2.64|<|0.001|TWO_SIDED|95.0|-52.21|-41.76||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-41.76|-52.21|<0.001
71127555|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.73|||||TWO_SIDED|95.0|-15.5|0.04||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.04|-15.50|
71127556|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.98|||||TWO_SIDED|95.0|-21.75|-6.21||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.21|-21.75|
71090284|NCT02842866|141686979|NON_INFERIORITY|The 95 percent (%) confidence internal (CI) of the difference in percentage was computed using the Wilson Score method without continuity correction. The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was greater than (\>) -10 percent (%) for all four serogroups.|Difference in percentage|15.7|||||TWO_SIDED|95.0|9.08|22.2||||||Serogroup A||22.2|9.08|
71090285|NCT02842866|141686979|NON_INFERIORITY|The 95% CI of the difference in percentage was computed using the Wilson Score method without continuity correction. The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all four serogroups.|Difference in percentage|27.5|||||TWO_SIDED|95.0|21.2|33.5||||||Serogroup C||33.5|21.2|
71090286|NCT02842866|141686979|NON_INFERIORITY|The 95% CI of the difference in percentage was computed using the Wilson Score method without continuity correction. The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all four serogroups.|Difference in percentage|31.0|||||TWO_SIDED|95.0|24.6|37.0||||||Serogroup Y||37.0|24.6|
71090287|NCT02842866|141686979|NON_INFERIORITY|The 95% CI of the difference in percentage was computed using the Wilson Score method without continuity correction. The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all four serogroups.|Difference in percentage|17.8|||||TWO_SIDED|95.0|11.2|24.2||||||Serogroup W||24.2|11.2|
71090288|NCT02842866|141686980|OTHER||GMT Ratio|1.75|||||TWO_SIDED|95.0|1.4|2.2||||||Serogroup A||2.20|1.40|
71090289|NCT02842866|141686980|OTHER||GMT Ratio|4.1|||||TWO_SIDED|95.0|3.16|5.33||||||Serogroup C||5.33|3.16|
71090290|NCT02842866|141686980|OTHER||GMT Ratio|3.3|||||TWO_SIDED|95.0|2.57|4.23||||||Serogroup Y||4.23|2.57|
71090291|NCT02842866|141686980|OTHER||GMT Ratio|1.81|||||TWO_SIDED|95.0|1.42|2.31||||||Serogroup W||2.31|1.42|
71090292|NCT02897349|141686988|SUPERIORITY||Adjusted Mean Difference (%)|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0016|TWO_SIDED|95.0|-0.65|-0.16|||Mixed model repeated measures|||Based on Mixed-effect Model Repeated Measures (MMRM) including fixed effects treatment, week, type of insulin, and treatment by week interaction, linear covariates baseline HbA1c, baseline HbA1c by week interaction and random effect for patient. Within-patient errors are modelled by unstructured covariance matrix. Adjusted mean is based on all patients in the model (not only patients with a baseline and week 24 measurement).||-0.16|-0.65|0.0016
71090293|NCT02897349|141686989|SUPERIORITY||Adjusted Mean Difference (mg/dL)|-6.2|STANDARD_ERROR_OF_MEAN|5.1||0.2241|TWO_SIDED|95.0|-16.2|3.8|||Mixed model repeated measures|||Based on MMRM including fixed effects treatment, week, type of insulin, and treatment by week interaction, linear covariates baseline HbA1c, baseline FPG baseline FPG by week interaction and random effect for patient. Within-patient errors are modelled by unstructured covariance matrix. Adjusted mean is based on all patients in the model (not only patients with a baseline and week 24 measurement).||3.8|-16.2|0.2241
71090294|NCT02897349|141686990|SUPERIORITY||Adjusted Mean Difference (mg/dL)|-31.95|STANDARD_ERROR_OF_MEAN|8.2||0.0001|TWO_SIDED|95.0|-48.15|-15.75|||ANCOVA|||Based on analysis of covariance (ANCOVA) model including fixed effect treatment and type of insulin, and linear covariates baseline HbA1c and baseline 2-h PPG.||-15.75|-48.15|0.0001
71090295|NCT02897349|141686991|SUPERIORITY||Odds Ratio (OR)|1.793||||0.2431|TWO_SIDED|95.0|0.673|4.78|||Regression, Logistic|||Logistic regression model with terms for treatment and type of insulin as fixed effect and continuous linear covariates baseline HbA1c||4.780|0.673|0.2431
71090296|NCT02897349|141686992|SUPERIORITY||Odds Ratio (OR)|1.481||||0.6235|TWO_SIDED|95.0|0.309|7.105|||Regression, Logistic|||Logistic regression model with terms for treatment and type of insulin as fixed effect and continuous linear covariates baseline HbA1c||7.105|0.309|0.6235
71090297|NCT02897349|141686993|SUPERIORITY||Odds Ratio (OR)|2.293||||0.0049|TWO_SIDED|95.0|1.286|4.091|||Regression, Logistic|||Logistic regression model with terms for treatment and type of insulin as fixed effect and continuous linear covariates baseline HbA1c||4.091|1.286|0.0049
71090298|NCT02737722|141687036|SUPERIORITY|||||||0.5152|||||||Fisher Exact|||Day 1 (Visit 2)||||0.5152
71090299|NCT02737722|141687036|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 1 (Visit 2)||||1.0000
71090300|NCT02737722|141687036|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 2 (Visit 3)||||1.0000
71090301|NCT02737722|141687036|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 2 (Visit 3)||||1.0000
71090302|NCT02737722|141687036|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 9 (Visit 4)||||1.0000
71090303|NCT02737722|141687036|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 9 (Visit 4)||||1.0000
71090304|NCT02737722|141687036|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 15 (Visit 5)||||1.0000
71090305|NCT02737722|141687036|SUPERIORITY|||||||0.3636|||||||Fisher Exact|||Day 15 (Visit 5)||||0.3636
71090306|NCT02737722|141687037|SUPERIORITY|||||||0.172|||||||Wilcoxon Rank Sum Test|||||||0.172
71090307|NCT02737722|141687037|SUPERIORITY|||||||0.365|||||||Wilcoxon Rank Sum Test|||||||0.365
71090308|NCT02737722|141687037|SUPERIORITY|||||||0.619|||||||Wilcoxon Rank Sum Test|||||||0.619
71090309|NCT02737722|141687038|SUPERIORITY|||||||0.432|||||||Wilcoxon Rank Sum Test|||||||0.432
71090310|NCT02737722|141687038|SUPERIORITY|||||||0.435|||||||Wilcoxon Rank Sum Test|||||||0.435
71090311|NCT02737722|141687038|SUPERIORITY|||||||0.715|||||||Wilcoxon Rank Sum Test|||||||0.715
71090312|NCT02737722|141687039|SUPERIORITY|||||||0.519|||||||Wilcoxon Rank Sum Test|||||||0.519
71090313|NCT02737722|141687039|SUPERIORITY|||||||0.519|||||||Wilcoxon Rank Sum Test|||||||0.519
71090314|NCT02737722|141687039|SUPERIORITY|||||||0.153|||||||Wilcoxon Rank Sum Test|||||||0.153
71090315|NCT02737722|141687040|SUPERIORITY|||||||0.464|||||||Wilcoxon Rank Sum Test|||||||0.464
71090316|NCT02737722|141687040|SUPERIORITY|||||||0.464|||||||Wilcoxon Rank Sum Test|||||||0.464
71090317|NCT02737722|141687040|SUPERIORITY|||||||0.465|||||||Wilcoxon Rank Sum Test|||||||0.465
70946475|NCT00846768|141393223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.034||0.0133||95.0|0.018|0.151|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.151|0.018|0.0133
70946476|NCT00846768|141393223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.034||0.045||95.0|0.002|0.135|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.135|0.002|0.0450
70946477|NCT00846768|141393223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.034||0.0078||95.0|0.025|0.159|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.159|0.025|0.0078
70872042|NCT01652703|141229481|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-37.22|STANDARD_ERROR_OF_MEAN|2.68|<|0.001|TWO_SIDED|95.0|-42.52|-31.91||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-31.91|-42.52|<0.001
70946478|NCT00846768|141393223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.034||0.6268||95.0|-0.05|0.083|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.083|-0.050|0.6268
70946479|NCT00846768|141393223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.034||0.4891||95.0|-0.044|0.091|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.091|-0.044|0.4891
71090318|NCT02737722|141687041|SUPERIORITY|||||||0.361|||||||Wilcoxon Rank Sum Test|||||||0.361
71090319|NCT02737722|141687041|SUPERIORITY|||||||0.519|||||||Wilcoxon Rank Sum Test|||||||0.519
71090320|NCT02737722|141687041|SUPERIORITY|||||||0.153|||||||Wilcoxon Rank Sum Test|||||||0.153
70946480|NCT00846768|141393224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.04||0.6259||95.0|-0.097|0.059|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.059|-0.097|0.6259
70946481|NCT00846768|141393224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.039||0.919||95.0|-0.082|0.074|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.074|-0.082|0.9190
71090321|NCT02737722|141687042|SUPERIORITY|||||||0.465|||||||Wilcoxon Rank Sum Test|||||||0.465
71090322|NCT02737722|141687042|SUPERIORITY|||||||0.464|||||||Wilcoxon Rank Sum Test|||||||0.464
71090323|NCT02737722|141687042|SUPERIORITY|||||||0.465|||||||Wilcoxon Rank Sum Test|||||||0.465
71090324|NCT02737722|141687044|SUPERIORITY|||||||0.465|||||||Wilcoxon Rank Sum Test|||||||0.465
71090325|NCT02737722|141687044|SUPERIORITY|||||||0.464|||||||Wilcoxon Rank Sum Test|||||||0.464
71090326|NCT02737722|141687044|SUPERIORITY|||||||0.465|||||||Wilcoxon Rank Sum Test|||||||0.465
71127557|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.45|||||TWO_SIDED|95.0|-0.53|13.42||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||13.42|-0.53|
71127558|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.06|||||TWO_SIDED|95.0|-5.81|7.92||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.92|-5.81|
70946482|NCT00846768|141393224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.066|STANDARD_ERROR_OF_MEAN|0.04||0.0985||95.0|-0.012|0.145|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.145|-0.012|0.0985
71090327|NCT00284856|141687064|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|5.92||||||95.0|0.28|11.56|||||Estimated Value is difference in least squares mean (montelukast - placebo)|||11.56|0.28|
71090328|NCT00284856|141687064|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|10.14||||||95.0|4.5|15.78|||||Estimated value is difference in least squares mean (fluticasone - placebo)|||15.78|4.50|
71090329|NCT00284856|141687064|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-4.22||||||95.0|-9.83|1.38|||||Estimated value is difference in least squares mean (montelukast - fluticasone)|||1.38|-9.83|
71090330|NCT00284856|141687065|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.15||||||95.0|-0.25|-0.05|||||Estimated value is difference in least squares mean (montelukast - placebo)|||-0.05|-0.25|
71090331|NCT00284856|141687065|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.2||||||95.0|-0.3|-0.1|||||Estimated value is difference in least squares mean (fluticasone - placebo)|||-0.10|-0.30|
71127559|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.66|||||TWO_SIDED|95.0|-6.25|7.57||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.57|-6.25|
71090332|NCT00284856|141687065|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.05||||||95.0|-0.05|0.15|||||Estimated value is difference in least squares mean (montelukast - fluticasone)|||0.15|-0.05|
71090333|NCT00284856|141687066|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|5.09||||||95.0|-1.27|11.45|||||Estimated value is difference in least squares mean (montelukast - placebo)|||11.45|-1.27|
71090334|NCT00284856|141687066|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|11.21||||||95.0|4.85|17.58|||||Estimated value is difference in least squares mean (fluticasone - placebo)|||17.58|4.85|
71090335|NCT00284856|141687066|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-6.13||||||95.0|-12.46|0.2|||||Estimated value is difference in least squares mean (montelukast - fluticasone)|||0.20|-12.46|
71090336|NCT00477685|141687085|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||Null hypothesis: the postoperative intraocular pressure at 90 days equals the preoperative intraocular pressure at baseline.||||0.01
71090337|NCT03040726|141687103|OTHER|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||||||0.98
71090338|NCT03040726|141687104|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.40
71090339|NCT03040726|141687105|OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
71090340|NCT03040726|141687106|OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
71090341|NCT03699748|141687171|OTHER||Mean Difference (Net)|10.92|||<|0.001|TWO_SIDED|95.0|7.27|14.58|||Type III F test|||||14.58|7.27|<0.001
71090342|NCT03699748|141687174|OTHER||Effect Estimate for 4 Months|12.88|||||TWO_SIDED||||||||12.88 (9.49 - 16.28)||Effect estimates were expected mean differences in Patient Activation Measure scores between groups from baseline. Effect estimates were estimated using generalized estimating equations (GEE) models as a function of treatment group, categorical time (baseline, 4 months and 12 months), and an interaction term between treatment group and time with an exchangeable correlation clustered within person. The effect estimate column shows the difference between change in the intervention group from baseline and the change in the control group from baseline.|||
71090343|NCT03699748|141687175|OTHER||Effect Estimate for 12 Months|20.65|||||TWO_SIDED||||||||20.65 (6.97 - 24.32)||Effect estimates were expected mean differences in Patient Activation Measure scores between groups from baseline. Effect estimates were estimated using generalized estimating equations (GEE) models as a function of treatment group, categorical time (baseline, 4 months and 12 months), and an interaction term between treatment group and time with an exchangeable correlation clustered within person.|||
71090344|NCT03699748|141687176|OTHER||Median Difference (Net)|11.05||||0.001|TWO_SIDED|95.0|7.09|15.0|||Type III F-test|||||15.00|7.09|0.001
71090345|NCT03699748|141687178|OTHER||Odds Ratio (OR)|0.91|||||TWO_SIDED||||||||0.91 (0.40-2.09)||Odds Ratios for any emergency room use and any hospitalization use were estimated using logistic regression models.|||
70946483|NCT00846768|141393224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.039||0.6991||95.0|-0.093|0.063|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.063|-0.093|0.6991
70946484|NCT00846768|141393224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.04||0.0802||95.0|-0.009|0.149|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.149|-0.009|0.0802
70946485|NCT00909532|141393271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.6|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|8.6|12.6||The primary and key secondary endpoints were analyzed using Hochberg's step-up procedure: test 1, primary (α=0.05); test 2, CFQ-R resp domain (Wk24) and sweat chloride (Wk24)(α=0.05).|Mixed Models Analysis|Denominator degrees of freedom were estimated using the Kenward-Roger approximation.||The primary analysis for the primary efficacy variable was based on a Mixed-Effects Model for Repeated Measures (MMRM). The model included absolute change from baseline in percent predicted forced expiratory volume in 1 second (FEV1) as the dependent variable, treatment (ivacaftor versus placebo) and visit (Day 15, Week 8, Week 16, and Week 24) as fixed effects, and subject as a random effect, with adjustment for the continuous baseline values of age and percent predicted FEV1.||12.6|8.6|<0.0001
71090346|NCT03699748|141687179|OTHER||Odds Ratio (OR)|0.27|||||TWO_SIDED||||||||0.27 (0.03 - 2.85)||Odds Ratios for any ED Use were estimated using logistic regression models.|||
71090347|NCT03699748|141687180|OTHER||Odds Ratio (OR)|0.38|||||TWO_SIDED||||||||0.38 (0.18-0.76)||Odds Ratios for any emergency room use and any hospitalization use were estimated using logistic regression models.|||
71090348|NCT03699748|141687181|OTHER||Odds Ratio (OR)|0.42|||||TWO_SIDED||||||||0.42 (0.22-0.79)||Odds Ratios for any emergency room use and any hospitalization use were estimated using logistic regression models.|||
71090349|NCT03699748|141687182|OTHER||Odds Ratio (OR)|0.38|||||TWO_SIDED||||||||0.38 (0.08-1.75)||Odds Ratios for Hospitalization Use were estimated using logistic regression models.|||
71090350|NCT03699748|141687183|OTHER||Odds Ratio, log|5.86|||||TWO_SIDED||||||||Odds Ratios for Goals of Care Documentation, Advance Directive Documentation, and Physician Order for Life Sustaining Treatment Documentation were estimated based on assessments 4-months and 12-months post-enrollment with logistic regression.|||||
71090351|NCT03699748|141687184|OTHER||Odds Ratio (OR)|4.09|||||TWO_SIDED||||||||Odds Ratios for Goals of Care Documentation, Advance Directive Documentation, and Physician Order for Life Sustaining Treatment Documentation were estimated based on assessments 4-months and 12-months post-enrollment with logistic regression.|||||
71090352|NCT03699748|141687185|OTHER||Odds Ratio (OR)|6.82|||||TWO_SIDED||||||||6.82 (2.46-18.93)||Odds Ratios for Physician Order for Life Sustaining Treatment Documentation were estimated based on assessments 4-months post-enrollment with logistic regression.|||
71090353|NCT03699748|141687186|OTHER||Odds Ratio (OR)|3.62|||||TWO_SIDED||||||||3.62 (1.73-7.60)||Odds Ratios for Physician Order for Life Sustaining Treatment Documentation were estimated based on assessments at 12-months post-enrollment with logistic regression.|||
71090354|NCT03699748|141687187|OTHER||Odds Ratio, log|8.56|||||TWO_SIDED||||||||Odds Ratios for Goals of Care Documentation, Advance Directive Documentation, and Physician Order for Life Sustaining Treatment Documentation were estimated based on assessments 4-months and 12-months post-enrollment with logistic regression.|||||
71090355|NCT03699748|141687188|OTHER||Odds Ratio, log|19.55|||||TWO_SIDED||||||||Odds Ratios for Goals of Care Documentation, Advance Directive Documentation, and Physician Order for Life Sustaining Treatment Documentation were estimated based on assessments at 12-months post-enrollment with logistic regression.|||||
71090356|NCT03699748|141687189|OTHER||Effect Estimate|0.65|||||TWO_SIDED||||||||0.65 (0.44-0.98)||Proportional change in total health care costs are expressed as referent to the control group and were modeled using a generalized linear model with gamma link-log function to account for skewed cost data after adjustment for length of follow-up.|||
71090357|NCT03699748|141687190|OTHER||Effect Estimate|0.57|||||TWO_SIDED||||||||0.57 (0.28 - 1.18)||Proportional change in total health care costs are expressed as referent to the control group and were modeled using a generalized linear model with gamma link-log function to account for skewed cost data.|||
71090358|NCT03699748|141687191|OTHER||Odds Ratio (OR)|6.82|||||TWO_SIDED||||||||6.82 (2.46-18.93)||Odds Ratios for palliative care receipt and hospice receipt were estimated based on assessments 4-months and 12-months post-enrollment compared with baseline (time of enrollment) using logistic regression.|||
71090359|NCT03699748|141687192|OTHER||Odds Ratio (OR)|3.62|||||TWO_SIDED||||||||3.62 (1.73-7.60)||Odds Ratios for palliative care receipt and hospice receipt were estimated based on assessments 4-months and 12-months post-enrollment compared with baseline (time of enrollment) using logistic regression.|||
70858176|NCT02360605|141202400|SUPERIORITY|||||||0.97||||||p-values control for age (in years), race (African American vs Caucasian and Hispanic), gender, and literacy (2 categories) The a priori threshold for statistical significance was p\<0.05|Mixed Models Analysis|||Multivariate analyses adjusting for age, race, gender, and health literacy level were done using generalized linear models. A test for interaction between study arm and each of literacy level, age, gender and race was performed to determine whether treatment effect differed by levels of these factors. An unadjusted test for the main effect of each of health literacy level, age, gender, race and study arm was performed to determine whether screening rates differed by levels of these factors.||||0.97
70858177|NCT01277081|141202419|SUPERIORITY_OR_OTHER||Adjusted Mean difference|0.72|||<|0.0001|TWO_SIDED|95.0|0.58|0.86|||Repeated Measure Analysis|Repeated measures analysis with factors for time and treatment\*time interaction. Baseline score was adjusted as part of the repeated measures series.|Difference was first named treatment minus second named treatment such that a positive difference favours the first named treatment|Null Hypothesis considered no difference in treatments being compared for breathing score over the first 15 minutes compared to baseline.||0.86|0.58|<0.0001
70858178|NCT01277081|141202420|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.58|||<|0.0001|TWO_SIDED|95.0|0.44|0.72|||Repeated measures analysis|Repeated measures analysis with factors for time and treatment\*time interaction. Baseline score was adjusted as part of the repeated measures series.|Difference was first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered no difference in treatments being compared for breathing score over 60 minutes.||0.72|0.44|<0.0001
70858179|NCT01277081|141202421|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.5|||<|0.0001|TWO_SIDED|95.0|0.36|0.65|||Repeated measures analysis|Repeated measures analysis with factors for time and treatment\*time interaction. Baseline score was adjusted as part of the repeated measures series.|Difference was first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null Hypothesis considered no difference in treatments being compared for cold symptoms score after 60 minutes.||0.65|0.36|<0.0001
71127560|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.42|||||TWO_SIDED|95.0|-9.26|4.42||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.42|-9.26|
71127561|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.91|||||TWO_SIDED|95.0|1.48|16.35||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||16.35|1.48|
71127562|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.13|||||TWO_SIDED|95.0|-3.24|11.51||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||11.51|-3.24|
71127563|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.44|||||TWO_SIDED|95.0|-6.96|7.84||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.84|-6.96|
71127564|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.21|||||TWO_SIDED|95.0|-5.14|9.56||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.56|-5.14|
71127565|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.35|||||TWO_SIDED|95.0|0.92|15.77||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||15.77|0.92|
71127566|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.38|||||TWO_SIDED|95.0|-6.03|8.8||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.80|-6.03|
71127567|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87|||||TWO_SIDED|95.0|-8.26|6.52||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||6.52|-8.26|
71127568|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.13|||||TWO_SIDED|95.0|-6.23|8.49||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.49|-6.23|
71127569|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.26|||||TWO_SIDED|95.0|1.46|17.06||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||17.06|1.46|
71127570|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.58|||||TWO_SIDED|95.0|-6.23|9.38||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.38|-6.23|
70872043|NCT01652703|141229481|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-46.66|STANDARD_ERROR_OF_MEAN|2.86|<|0.001|TWO_SIDED|95.0|-52.32|-41.0||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-41.00|-52.32|<0.001
70858180|NCT01277081|141202422|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.52|||<|0.0001|TWO_SIDED|95.0|0.38|0.67|||Repeated measures analysis|Repeated measures analysis with factors for time and treatment\*time interaction. Baseline score was adjusted as part of the repeated measures series.|Difference was first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered two treatments being compared to be equal for cold symptom score after 60 minutes.||0.67|0.38|<0.0001
70858181|NCT02524977|141202445|SUPERIORITY_OR_OTHER|||||||0.02|||||||Chi-squared|||||||0.02
70858182|NCT01673282|141202452|SUPERIORITY_OR_OTHER||Least Square Mean|-0.24|STANDARD_ERROR_OF_MEAN|0.06|=|0.0003|TWO_SIDED|95.0|-0.36|-0.11|||ANCOVA|||Based on an ANCOVA model for absolute change in ratio of dose and DDD with group as a fixed effect and the ratio of dose and DDD at Baseline as a covariate.||-0.11|-0.36|=0.0003
70946486|NCT00909532|141393272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.5|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|8.5|12.5||There was no adjustment for multiple comparisons.|Mixed Models Analysis|Denominator degrees of freedom were estimated using the Kenward-Roger approximation. No imputation of missing data was done.||Analysis of this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were obtained from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for the continuous baseline values of age and percent predicted forced expiratory volume in 1 second (FEV1),using unstructured covariance matrix.||12.5|8.5|<0.0001
70946487|NCT00909532|141393273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.1|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|TWO_SIDED|95.0|4.7|11.4||Analyzed in sequence: test 1, primary (α=0.05); test 2, using Hochberg's step-up procedure on CFQ-R resp domain(Wk 24) and sweat chloride (Wk 24) (α=0.05).|Mixed Models Analysis|||Through Week 24: Analysis for the respiratory domain score endpoint was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for age, domain score, and percent predicted FEV1, using unstructured covariance matrix.||11.4|4.7|<0.0001
70858183|NCT03935399|141202453|SUPERIORITY|Exploratory analysis without power calculation||||||0.83|||||||ANOVA|Repeated measures one factor ANOVA||Exploratory analysis without power calculation||||0.83
70946488|NCT00909532|141393273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|TWO_SIDED|95.0|5.3|11.9||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Through Week 48: Analysis for the CFQ-R respiratory domain score endpoint was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from MMRM with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for age,sweat chloride, and percent predicted FEV1,using unstructured covariance matrix.||11.9|5.3|<0.0001
71127571|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-10.27|5.27||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.27|-10.27|
71127572|NCT01393639|141760272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.79|||||TWO_SIDED|95.0|-5.95|9.53||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.53|-5.95|
71127573|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.87|||||TWO_SIDED|95.0|-10.89|5.14||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.14|-10.89|
71127574|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.86|||||TWO_SIDED|95.0|-14.8|1.08||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.08|-14.80|
71127575|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.36|||||TWO_SIDED|95.0|-22.34|-6.38||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.38|-22.34|
71127576|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.32|||||TWO_SIDED|95.0|-20.22|-4.41||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.41|-20.22|
71127577|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.14|||||TWO_SIDED|95.0|-10.12|5.85||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.85|-10.12|
70858184|NCT03935399|141202454|SUPERIORITY|Exploratory analysis without power calculation||||||0.92|||||||ANOVA|One factor repeated measures ANOVA||Exploratory analysis without power calculation||||0.92
70858185|NCT03935399|141202455|SUPERIORITY|Exploratory analysis without power calculation||||||0.79|||||||ANOVA|One factor repeated measures ANOVA||Exploratory analysis without power calculation||||0.79
70858186|NCT03935399|141202456|SUPERIORITY|Exploratory analysis without power calculation||||||0.93||||||Exploratory analysis without power calculation|ANOVA|One factor repeated measures ANOVA||||||0.93
70858187|NCT03935399|141202457|SUPERIORITY|Exploratory analysis without power calculation||||||0.89||||||Exploratory analysis without power calculation|ANOVA|Two factor repeated measures ANOVA||||||0.89
70858188|NCT03935399|141202458|SUPERIORITY|Exploratory analysis without power calculation||||||0.83||||||Exploratory analysis without power calculation|ANOVA|Two way repeated measures ANOVA||||||0.83
70858189|NCT03935399|141202459|SUPERIORITY|Exploratory analysis without power caclulation||||||0.57||||||Exploratory analysis without power caclulation|ANOVA|Two way repeated measures ANOVA||||||0.57
70858190|NCT01112683|141202460|SUPERIORITY_OR_OTHER|||||||0.403|ONE_SIDED|90.0|||||Mixed Models Analysis|An alpha level of 0.05 or lower represents statistical significance, no correction was made for multiple comparisons to minimize type II errors.||20 subjects per group were expected to provide 60% power to detect a between-group mean difference of 1.2 correct patterns (change from baseline to week 16) on the Paired Associates Learning and to provide 40% power to detect a between-group mean difference of 1.2 patterns recognized on the Pattern Recognition Memory. A two-sided test at type I error rate of 5% was used. Sample size incorporated an inflation factor of 20% to account for ineligibility of 10% of randomized participants.||||0.403
70858191|NCT01112683|141202461|SUPERIORITY_OR_OTHER|||||||0.371|ONE_SIDED|90.0||||This P-Value refers to the SIB-R Broad independence score.|Mixed Models Analysis|An alpha level of 0.05 or lower represents statistical significance, no correction was made for multiple comparisons to minimize type II errors.||No power calculations were performed for the secondary measures.||||0.371
71127578|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.05|||||TWO_SIDED|95.0|-22.05|-6.04||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.04|-22.05|
70858192|NCT02106923|141202469|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|102.98|STANDARD_ERROR_OF_MEAN|1.014|<|0.0001|TWO_SIDED|90.0|100.505|105.514|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)|||105.514|100.505|<0.0001
70858193|NCT02106923|141202469|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|100.25|STANDARD_ERROR_OF_MEAN|1.021|<|0.0001|TWO_SIDED|90.0|96.809|103.823|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)|||103.823|96.809|<0.0001
70858194|NCT02106923|141202469|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|96.08|STANDARD_ERROR_OF_MEAN|1.016|<|0.0001|TWO_SIDED|90.0|93.507|98.721|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)|||98.721|93.507|<0.0001
71127579|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.26|||||TWO_SIDED|95.0|-9.83|7.3||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.30|-9.83|
71127580|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.1|||||TWO_SIDED|95.0|-18.67|-1.53||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.53|-18.67|
71127581|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.41|||||TWO_SIDED|95.0|-24.01|-6.82||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.82|-24.01|
71127582|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.79|||||TWO_SIDED|95.0|-20.33|-3.26||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.26|-20.33|
70858195|NCT02106923|141202470|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|102.04|STANDARD_ERROR_OF_MEAN|1.06||0.0011|TWO_SIDED|90.0|92.3|112.81|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)|||112.81|92.30|0.0011
70858196|NCT02106923|141202470|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|98.93|STANDARD_ERROR_OF_MEAN|1.02|<|0.0001|TWO_SIDED|90.0|95.45|102.53|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)|||102.53|95.45|<0.0001
70858197|NCT02106923|141202470|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|101.7|STANDARD_ERROR_OF_MEAN|1.05||0.0002|TWO_SIDED|90.0|93.59|110.52|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)|||110.52|93.59|0.0002
70858198|NCT02106923|141202471|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|102.88|STANDARD_ERROR_OF_MEAN|1.014|<|0.0001|TWO_SIDED|90.0|100.446|105.373|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)|||105.373|100.446|<0.0001
70858199|NCT02106923|141202471|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|100.03|STANDARD_ERROR_OF_MEAN|1.021|<|0.0001|TWO_SIDED|90.0|96.448|103.738|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)|||103.738|96.448|<0.0001
70858200|NCT02106923|141202471|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|96.49|STANDARD_ERROR_OF_MEAN|1.017|<|0.0001|TWO_SIDED|90.0|93.758|99.311|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)|||99.311|93.758|<0.0001
70858201|NCT02106923|141202472|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|104.83|STANDARD_ERROR_OF_MEAN|1.031|<|0.0001|TWO_SIDED|90.0|99.522|110.412|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)|||110.412|99.522|<0.0001
70946489|NCT00909532|141393274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.9|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|TWO_SIDED|95.0|-51.3|-44.5||Analyzed in sequence: test 1, primary (α=0.05); test 2, using Hochberg's step-up procedure on CFQ-R resp domain(Wk 24) and sweat chloride (Wk 24) (α=0.05); test 3 using Hochberg's on time to pulmonary exacerbation (Wk 48) and weight (Wk 48).|Mixed Models Analysis|||Through Week 24: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for age, sweat chloride, and percent predicted FEV1, using unstructured covariance matrix.||-44.5|-51.3|<0.0001
71090360|NCT03699748|141687193|OTHER||Effect Estimate|5.71|||||TWO_SIDED||||||||5.71 (1.56-20.93)||Odds Ratios for any ED Use and any Palliative Care were estimated using logistic regression models. Incidence Rate Ratios (IRR) were estimated using Poisson models. All ratios are expressed as referent to the control group.|||
70858202|NCT02106923|141202472|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|101.84|STANDARD_ERROR_OF_MEAN|1.041|<|0.0001|TWO_SIDED|90.0|95.03|109.134|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)|||109.134|95.030|<0.0001
70946490|NCT00909532|141393274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-48.1|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|TWO_SIDED|95.0|-51.5|-44.7||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Through Week 48: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for age, sweat chloride, and percent predicted FEV1, using unstructured covariance matrix.||-44.7|-51.5|<0.0001
71090361|NCT03699748|141687194|OTHER||Odds Ratio (OR)|4.33|||||TWO_SIDED||||||||4.33 (0.89-21.08)||Odds Ratios for palliative care receipt and hospice receipt were estimated based on assessments 4-months and 12-months post-enrollment compared with baseline (time of enrollment) using logistic regression.|||
71090362|NCT03699748|141687195|OTHER||Odds Ratio (OR)|2.76|||||TWO_SIDED||||||||2.76 (1.01-7.55)||Odds Ratios for palliative care receipt and hospice receipt were estimated based on assessments at 12-months post-enrollment compared with baseline (time of enrollment) using logistic regression.|||
71090363|NCT03699748|141687196|OTHER||Effect Estimate|5.71|||||TWO_SIDED||||||||5.71 (1.56-20.93)||Odds Ratios for any ED Use and any Hospice Receipt were estimated using logistic regression models. Incidence Rate Ratios (IRR) were estimated using Poisson models. All ratios are expressed as referent to the control group.|||
71127583|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.98|||||TWO_SIDED|95.0|-14.57|2.62||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.62|-14.57|
71127584|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.37|||||TWO_SIDED|95.0|-23.98|-6.76||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.76|-23.98|
70858203|NCT02106923|141202472|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|96.03|STANDARD_ERROR_OF_MEAN|1.037|<|0.0001|TWO_SIDED|90.0|90.217|102.211|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)|||102.211|90.217|<0.0001
70858204|NCT02106923|141202473|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|98.94|STANDARD_DEVIATION|1.071||0.0027|TWO_SIDED|90.0|87.925|111.329|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)|||111.329|87.925|0.0027
70946491|NCT00909532|141393275|SUPERIORITY_OR_OTHER||Cox Proportional Hazard at Week 24|0.4||||0.0016|TWO_SIDED|95.0|0.23|0.71||There was no adjustment for multiple comparisons.|Regression, Cox|||Time to first pulmonary exacerbation through Week 24 was analyzed using Cox regression. The model included a covariate for treatment and adjustments for the age group and percent predicted forced expiratory volume in 1 second (FEV1) severity at baseline.||0.71|0.23|0.0016
71090364|NCT01499810|141687209|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
71090365|NCT01499810|141687211|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
71090366|NCT01499810|141687212|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
71090367|NCT01499810|141687213|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
71090368|NCT01499810|141687214|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
71090369|NCT01499810|141687215|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
71090370|NCT01499810|141687216|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.0001
71090371|NCT01499810|141687217|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
71090372|NCT01499810|141687218|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.35
71090373|NCT01499810|141687219|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.12
71090374|NCT01499810|141687220|SUPERIORITY_OR_OTHER_LEGACY|||||||7e-05||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.00007
71090375|NCT01499810|141687221|SUPERIORITY_OR_OTHER_LEGACY|||||||9e-05||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.00009
70946492|NCT00909532|141393275|SUPERIORITY_OR_OTHER||Cox Proportional Hazard at 48 Weeks|0.46||||0.0012|TWO_SIDED|95.0|0.28|0.73||Analyzed in sequence: test 1, primary (α=0.05); test 2, using Hochberg's step-up procedure on CFQ-R resp domain(Wk 24) and sweat chloride (Wk 24) (α=0.05); test 3 using Hochberg's on time to pulmonary exacerbation (Wk 48) and weight (Wk 48).|Regression, Cox|||Time to first pulmonary exacerbation through Week 48 was analyzed using Cox regression. The model included a covariate for treatment and adjustments for the age group and percent predicted forced expiratory volume in 1 second (FEV1) severity at baseline.||0.73|0.28|0.0012
71090376|NCT01499810|141687222|SUPERIORITY_OR_OTHER_LEGACY|||||||4e-05||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.00004
71090377|NCT01499810|141687223|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.0001
71090378|NCT01499810|141687224|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.0007
71090379|NCT01499810|141687225|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.001
71090380|NCT01499810|141687226|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.0004
71090381|NCT01499810|141687227|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.0002
71090382|NCT01499810|141687228|SUPERIORITY_OR_OTHER_LEGACY|||||||0.57||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.57
71090383|NCT01499810|141687229|SUPERIORITY_OR_OTHER_LEGACY|||||||0.54||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.54
71090384|NCT01499810|141687230|SUPERIORITY_OR_OTHER_LEGACY|||||||0.87||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.87
71090385|NCT01499810|141687231|SUPERIORITY_OR_OTHER_LEGACY|||||||0.77||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.77
71090386|NCT01499810|141687232|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.06
71090387|NCT01499810|141687233|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.07
70858205|NCT02106923|141202473|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|108.18|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|102.792|113.859|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)|||113.859|102.792|<0.0001
71090388|NCT01499810|141687234|SUPERIORITY_OR_OTHER_LEGACY|||||||0.32||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.32
71090389|NCT01499810|141687235|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.12
71090390|NCT01499810|141687236|SUPERIORITY_OR_OTHER_LEGACY|||||||0.72||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.72
71090391|NCT01499810|141687237|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.37
71090392|NCT01499810|141687238|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.99
71090393|NCT01499810|141687239|SUPERIORITY_OR_OTHER_LEGACY|||||||0.76||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.76
71090394|NCT01499810|141687240|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.08
71090395|NCT01499810|141687241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.35
71090396|NCT01499810|141687242|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.22
71090397|NCT01499810|141687243|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.29
71090398|NCT01499810|141687244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.89
71127585|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|||||TWO_SIDED|95.0|-9.49|9.03||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.03|-9.49|
71090399|NCT01499810|141687245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.65||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.65
71090400|NCT01499810|141687246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.76||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.76
71090401|NCT01499810|141687247|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||||||Repeated measures analysis|t-test, 2 sided|||Repeated measures analysis||||0.35
71090402|NCT01499810|141687248|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.92
71090403|NCT01499810|141687249|SUPERIORITY_OR_OTHER_LEGACY|||||||0.32||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.32
71090404|NCT01499810|141687250|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.40
71090405|NCT01499810|141687251|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.17
71090406|NCT01499810|141687252|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.014
71090407|NCT03658980|141687259|SUPERIORITY||Odds Ratio (OR)|0.233|||<|0.001|TWO_SIDED|95.0|0.131|0.415|||Regression, Logistic|||||0.415|0.131|<0.001
71090408|NCT02273167|141687267|NON_INFERIORITY_OR_EQUIVALENCE|The confidence limits (CL) were adjusted for multiple comparisons (two alternative primary endpoints): To be declared non-inferior, the primary endpoint must show a difference in success rates of no greater than 10% in favour of MOVIPREP using lower 1-sided 97.5% CL. Calculated using exact Clopper-Pearson CLs. To accommodate the comparison of 2 NER1006 regimens a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated.|Difference in success rate|4.5||||0.055|ONE_SIDED|97.5|-4.0|||The p-value was adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||Hypothesis was to demonstrate non-inferiority (NI) of NER1006 2-Day to MOVIPREP (10% margin). Success rate was no. of patients with successful overall bowel cleansing as proportion of no. of patients in each group. Treatment effect was NER1006 2-Day success rate - MOVIPREP success rate. Hochberg procedure used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||-4.00|0.055
71090409|NCT02273167|141687267|NON_INFERIORITY_OR_EQUIVALENCE|The CLs were adjusted for multiple comparisons (2 alternative primary endpoints): To be declared non-inferior, the primary endpoint must show a difference in success rates of no greater than 10% in favour of MOVIPREP using lower 1-sided 97.5% CLs. Calculated using exact Clopper-Pearson confidences limits. To accommodate the comparison of two NER1006 regimens a hierarchical testing approach will be used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated.|Difference in success rate|1.59||||0.328|ONE_SIDED|97.5|-6.91|||The p-value was adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||The hypothesis was to demonstrate NI of NER1006 1-Day to MOVIPREP (10% margin). Success rate was number of patients with successful overall bowel cleansing as proportion of number of patients in each group. Treatment effect was NER1006 1-Day success rate - MOVIPREP success rate. A Hochberg procedure was used to control Type I error since there were two alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||-6.91|0.328
71090410|NCT02273167|141687268|NON_INFERIORITY_OR_EQUIVALENCE|Confidence limits (CL) were adjusted for multiple comparisons (2 alternative primary endpoints): To be declared non-inferior the primary endpoint must show a difference in success rates of no greater than 10% in favour of MOVIPREP using lower 1-sided 97.5% CLs. Calculated using exact Clopper-Pearson CLs. To accommodate the comparison of two NER1006 regimens a hierarchical testing approach will be used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated.|Difference in excellent plus good rate|16.56|||<|0.001|ONE_SIDED|97.5|8.11|||The p-value was adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||Hypothesis was to demonstrate NI of NER1006 2-Day to MOVIPREP (10% margin). Success rate was no. of patients with highly effective cleansing of the colon ascendens as proportion of no. of patients in each group. Treatment effect was NER1006 2-Day success rate - MOVIPREP success rate. Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||8.11|<0.001
71090411|NCT02273167|141687268|NON_INFERIORITY_OR_EQUIVALENCE|The confidence limits (CLs) were adjusted for multiple comparisons (2 alternative primary endpoints): To be declared non-inferior the primary endpoint must show a difference in success rates of no greater than 10% in favour of MOVIPREP using lower 1-sided 97.5% CLs. Calculated using exact Clopper-Pearson CLs. To accommodate the comparison of 2 NER1006 regimens a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated.|Difference in excellent plus good rate|18.74|||<|0.001|ONE_SIDED|97.5|10.32|||The p-value was adjusted for multiple comparisons (2 alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||Hypothesis was to demonstrate NI of NER1006 1-Day to MOVIPREP (10% margin). Success rate was no. of patients with highly effective cleansing of the colon ascendens as proportion of no. of patients in each group. Treatment effect was NER1006 1-Day success rate - MOVIPREP success rate. Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||10.32|<0.001
71090412|NCT02273167|141687269|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of MOVIPREP using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|3.55||||0.106|TWO_SIDED|95.0|-4.8|12.0||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 2-Day relative to MOVIPREP with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 2-Day rate - MOVIPREP rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||12.00|-4.80|0.106
71127586|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.36|||||TWO_SIDED|95.0|-19.64|-1.08||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.08|-19.64|
71127587|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.57|||||TWO_SIDED|95.0|-24.83|-6.32||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.32|-24.83|
71090413|NCT02273167|141687269|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of MOVIPREP using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|3.55||||0.106|TWO_SIDED|95.0|-4.8|12.0||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 1-Day relative to MOVIPREP with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 1-Day rate - MOVIPREP rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||12.00|-4.80|0.106
71127588|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.34|||||TWO_SIDED|95.0|-20.56|-2.13||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.13|-20.56|
71127589|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.36|||||TWO_SIDED|95.0|-14.61|3.89||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.89|-14.61|
71127590|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.88|||||TWO_SIDED|95.0|-25.15|-6.61||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.61|-25.15|
71127591|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.69|||||TWO_SIDED|95.0|-10.32|8.94||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.94|-10.32|
71127592|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.27|||||TWO_SIDED|95.0|-19.95|-0.59||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.59|-19.95|
71127593|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.7|||||TWO_SIDED|95.0|-29.34|-10.06||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-10.06|-29.34|
71127594|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.65|||||TWO_SIDED|95.0|-22.25|-3.04||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.04|-22.25|
71127595|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.6|||||TWO_SIDED|95.0|-17.24|2.04||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.04|-17.24|
71127596|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.34|||||TWO_SIDED|95.0|-28.99|-9.68||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-9.68|-28.99|
71127597|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.17|||||TWO_SIDED|95.0|3.18|19.16||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||19.16|3.18|
71127598|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.19|||||TWO_SIDED|95.0|-0.78|15.15||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||15.15|-0.78|
71127599|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|||||TWO_SIDED|95.0|-8.28|7.65||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.65|-8.28|
71127600|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.73|||||TWO_SIDED|95.0|-6.14|9.61||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.61|-6.14|
71127601|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.11|||||TWO_SIDED|95.0|5.51|22.71||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||22.71|5.51|
71127602|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.27|||||TWO_SIDED|95.0|-3.38|13.92||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||13.92|-3.38|
71090414|NCT02273167|141687270|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of MOVIPREP using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|-0.29||||0.569|TWO_SIDED|95.0|-8.74|8.02||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 2-Day relative to MOVIPREP with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 2-Day rate - MOVIPREP rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||8.02|-8.74|0.569
70946493|NCT00909532|141393276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|1.8|3.7|||Mixed Models Analysis|There was no adjustment for multiple comparisons.||At Week 24: Analysis for this variable was based on a linear mixed effects (LME) model with treatment as a fixed effect, and intercept, visit (days on study) and treatment by visit interaction as random effects, with adjustment for age group and baseline percent predicted forced expiratory volume in 1 second (FEV1) severity.||3.7|1.8|<0.0001
71090415|NCT02273167|141687270|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of MOVIPREP using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|0.8||||0.455|TWO_SIDED|95.0|-7.65|9.11||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 1-Day relative to MOVIPREP with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 1-Day rate - MOVIPREP rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||9.11|-7.65|0.455
71090416|NCT02273167|141687271|NON_INFERIORITY_OR_EQUIVALENCE|To accommodate the comparison of two NER1006 regimens, a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated. Difference in Polyp Detection Rate in the colon ascendens was calculated as NER1006 2-Day rate - MOVIPREP rate (10% margin) determined using exact Clopper-Pearson confidence limits.|Difference in PDR|7.1||||0.024|TWO_SIDED|95.0|-1.41|15.47|||Fisher Exact|||If at least one of the primary endpoints were met, then key secondary endpoints were evaluated hierarchically in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of MOVIPREP. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.||15.47|-1.41|0.024
70858206|NCT02106923|141202473|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|103.62|STANDARD_ERROR_OF_MEAN|1.071||0.006|TWO_SIDED|90.0|92.116|116.559|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)|||116.559|92.116|0.0060
70946494|NCT00909532|141393276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|0.7||0.0001|TWO_SIDED|95.0|1.3|4.1||Analyzed in sequence: test 1, primary (α=0.05); test 2, using Hochberg's step-up procedure on CFQ-R resp domain(Wk 24) and sweat chloride (Wk 24) (α=0.05).|Mixed Models Analysis|||At Week 48: Analysis for this variable was based on a linear mixed effects (LME) model with treatment as a fixed effect and visit (days on study) and treatment by visit interaction as random effects, with adjustment for age group and baseline percent predicted forced expiratory volume in 1 second (FEV1) severity.||4.1|1.3|0.0001
71090417|NCT02273167|141687271|NON_INFERIORITY_OR_EQUIVALENCE|To accommodate the comparison of two NER1006 regimens, a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated. Difference in Polyp Detection Rate in the colon ascendens was calculated as NER1006 rate - MOVIPREP rate (10% margin) determined using exact Clopper-Pearson confidence limits. Non-inferiority of NER1006 1-Day to MOVIPREP was proven.|Difference in PDR|2.37||||0.268|TWO_SIDED|95.0|-6.12|10.82||Superiority of NER1006 1-Day to MOVIPREP not demonstrated statistically.|Fisher Exact|||If at least one of the primary endpoints were met, then key secondary endpoints were evaluated hierarchically in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of MOVIPREP. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.||10.82|-6.12|0.268
71090418|NCT02273167|141687272|NON_INFERIORITY_OR_EQUIVALENCE|To accommodate the comparison of two NER1006 regimens, a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated. Difference in Polyp Detection Rate in the overall colon was calculated as NER1006 rate - MOVIPREP rate (10% margin) determined using exact Clopper-Pearson confidence intervals.|Difference in PDR|-0.49||||0.579|TWO_SIDED|95.0|-8.85|8.0|||Fisher Exact|||If at least one of the primary endpoints were met, then key secondary endpoints were evaluated hierarchically in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of MOVIPREP. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.||8.00|-8.85|0.579
71127603|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-8.68|8.59||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.59|-8.68|
71127604|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.58|||||TWO_SIDED|95.0|-4.99|12.15||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||12.15|-4.99|
70946495|NCT00859976|141393277|SUPERIORITY|A superiority test was used to calculate the number of patients that are needed in order to show a difference between the bone mineral density surrounding BoneMaster coated cups compared to plasma HA sprayed cups.||||||0.457|||||||Wilcoxon (Mann-Whitney)|Change in bone mineral density, normalised to baseline levels.||||||0.4570
70946496|NCT00984698|141393294|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||Analysis must be qualified by small sample size, worse baseline symptom severity in CBSRT arm, and greater levels of attrition in PCGT arm||||<.05
71090419|NCT02273167|141687272|NON_INFERIORITY_OR_EQUIVALENCE|To accommodate the comparison of two NER1006 regimens, a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated. Difference in Polyp Detection Rate in the overall colon was calculated as NER1006 1-Day rate - MOVIPREP rate (10% margin) determined using exact Clopper-Pearson confidence limits.|Difference in PDR|0.61||||0.478|TWO_SIDED|95.0|-7.78|9.09|||Fisher Exact|||If at least one of the primary endpoints were met, then key secondary endpoints were evaluated hierarchically in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of MOVIPREP. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.||9.09|-7.78|0.478
71127605|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.65|||||TWO_SIDED|95.0|6.38|24.93||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||24.93|6.38|
71127606|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.53|||||TWO_SIDED|95.0|-3.81|14.86||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||14.86|-3.81|
70946497|NCT00984698|141393295|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||Analysis must be qualified by small sample size, worse baseline symptom severity in CBSRT arm, and greater levels of attrition in PCGT arm||||<.05
70946498|NCT03029819|141393310|SUPERIORITY|||||||0.52|||||||Chi-squared|||||||.52
71090420|NCT03353220|141687296|OTHER|||||||0.65||||||paired t test|t-test, 2 sided|||||||0.65
71090421|NCT03353220|141687297|OTHER|||||||0.0001||||||paired t test|t-test, 2 sided|||||||0.0001
71090422|NCT03353220|141687298|OTHER|||||||0.0017||||||paired t test|t-test, 2 sided|||||||0.0017
71090423|NCT03353220|141687302|OTHER|||||||0.0189|||||||t-test, 2 sided|||||||0.0189
71127607|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|||||TWO_SIDED|95.0|-8.97|9.59||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.59|-8.97|
70946499|NCT03559829|141393336|OTHER|||||||0.025|||||||paired t-test|||||||0.025
70946500|NCT03559829|141393337|OTHER|||||||0.01|||||||paired t-test|||||||0.01
70946501|NCT03559829|141393338|OTHER|||||||0.3|||||||paired t-test|||||||0.3
70946502|NCT03559829|141393339|OTHER|||||||0.098|||||||paired t-test|||||||0.098
71090424|NCT00498550|141687315|SUPERIORITY||difference in treatment means|-4.54|STANDARD_ERROR_OF_MEAN|2.57||0.088|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.|||||.088
71090425|NCT01721798|141687369|NON_INFERIORITY|Primary Outcome Analysis: Proportion of women with detectable genital viral load across 24 months|Odds Ratio (OR)|0.87||||0.66|TWO_SIDED|95.0|0.47|1.62|||GEE|||C-IUD is comparator group.||1.62|0.47|0.66
71090426|NCT01721798|141687370|NON_INFERIORITY|Secondary Outcome Analysis of Proportion with Detectable plasma viral load users at 24 months|Odds Ratio (OR)|0.83||||0.64|TWO_SIDED|95.0|0.37|1.86|||GEE|Adjusted as-treated analysis||C-IUD is comparator group.||1.86|0.37|0.64
71090427|NCT01721798|141687372|NON_INFERIORITY|Secondary Outcome Analysis of Allocated IUC continuation at 24 months|Hazard Ratio (HR)|8.61|||<|0.001|TWO_SIDED|95.0|3.03|24.4|||Regression, Cox|||C-IUD is comparator group.||24.4|3.03|<0.001
70946503|NCT03559829|141393340|OTHER|||||||0.2|||||||paired t-test|||||||0.2
71127608|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.54|||||TWO_SIDED|95.0|-4.69|13.77||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||13.77|-4.69|
71127609|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.65|||||TWO_SIDED|95.0|9.03|28.27||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||28.27|9.03|
71127610|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.07|||||TWO_SIDED|95.0|-0.64|18.78||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||18.78|-0.64|
71127611|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-10.0|9.28||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.28|-10.00|
71127612|NCT01393639|141760274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.69|||||TWO_SIDED|95.0|-2.91|16.29||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||16.29|-2.91|
71127613|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-0.37|-0.02||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.02|-0.37|
71127614|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|||||TWO_SIDED|95.0|-0.46|-0.11||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.11|-0.46|
71127615|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|||||TWO_SIDED|95.0|-0.45|-0.1||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.10|-0.45|
71127616|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|||||TWO_SIDED|95.0|-0.52|-0.18||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.18|-0.52|
71127617|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|||||TWO_SIDED|95.0|-0.35|0.0||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.00|-0.35|
71127618|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-0.53|-0.18||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.18|-0.53|
70858207|NCT02106923|141202474|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|98.33|STANDARD_ERROR_OF_MEAN|1.06||0.0008|TWO_SIDED|90.0|89.13|108.47|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)|||108.47|89.13|0.0008
71127619|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|||||TWO_SIDED|95.0|-0.31|0.07||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.07|-0.31|
71127620|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-0.54|-0.17||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.17|-0.54|
71127621|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|||||TWO_SIDED|95.0|-0.47|-0.09||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.09|-0.47|
71127622|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|||||TWO_SIDED|95.0|-0.56|-0.18||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.18|-0.56|
70946504|NCT03559829|141393341|OTHER|||||||0.07|||||||paired t-test|||||||0.07
70946505|NCT01536197|141393343|SUPERIORITY_OR_OTHER|||||||0.19|||||||ANOVA|Two-way ANOVAs with group (gastric bypass and lap banding) as the between-subjects factor and time (before after surgery).||||||0.19
70946506|NCT01024036|141393477|SUPERIORITY_OR_OTHER||difference in the response rate|34.0||||0.0012|TWO_SIDED|95.0|11.1|54.8|||Cochran-Mantel-Haenszel|Adjusted for the stratification factor: corticosteroid use||Null hypothesis: there is no difference in the durable tumor and symptomatic response rate between the 2 treatment arms||54.8|11.1|0.0012
71127623|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.39|-0.01||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.01|-0.39|
71127624|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44|||||TWO_SIDED|95.0|-0.63|-0.25||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.25|-0.63|
71127625|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|||||TWO_SIDED|95.0|-0.34|0.05||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.05|-0.34|
71127626|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-0.59|-0.2||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.20|-0.59|
71127627|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|||||TWO_SIDED|95.0|-0.51|-0.12||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.12|-0.51|
71127628|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|||||TWO_SIDED|95.0|-0.55|-0.16||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.16|-0.55|
71127629|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.18|||||TWO_SIDED|95.0|-0.38|0.01||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.01|-0.38|
71127630|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.47|||||TWO_SIDED|95.0|-0.67|-0.27||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.27|-0.67|
71127631|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|||||TWO_SIDED|95.0|-0.3|0.15||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.15|-0.30|
71127632|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-0.63|-0.18||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.18|-0.63|
71127633|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41|||||TWO_SIDED|95.0|-0.64|-0.18||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.18|-0.64|
71127634|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-0.59|-0.14||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.14|-0.59|
71127635|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|||||TWO_SIDED|95.0|-0.54|-0.09||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.09|-0.54|
71127636|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.58|||||TWO_SIDED|95.0|-0.81|-0.35||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.35|-0.81|
71127637|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|||||TWO_SIDED|95.0|-0.01|0.34||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.34|-0.01|
71127638|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|||||TWO_SIDED|95.0|-0.1|0.24||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.24|-0.10|
71127639|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|||||TWO_SIDED|95.0|-0.1|0.25||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.25|-0.10|
71127640|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.17|0.18||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.18|-0.17|
70946507|NCT01024036|141393477|SUPERIORITY_OR_OTHER||difference in the response rate|34.0||||0.0004|TWO_SIDED|95.0|11.1|54.8|||Fisher Exact|Without adjusting for the stratification factor: corticosteroid use||Null hypothesis: there is no difference in the durable tumor and symptomatic response rate between the 2 treatment arms||54.8|11.1|0.0004
70946508|NCT01024036|141393479|SUPERIORITY_OR_OTHER||Difference in overall response rates|33.9||||0.0022|TWO_SIDED|95.0|11.1|54.8|||Cochran-Mantel-Haenszel|||||54.8|11.1|0.0022
70946509|NCT01024036|141393481|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.418||||0.0084|TWO_SIDED|95.0|0.214|0.815|||Log Rank||Hazard ratio and 95% CI from a Cox proportional hazards model|||0.815|0.214|0.0084
71090428|NCT01394276|141687390|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0237|||||||Exact binomial proportion test|||||||0.0237
71090429|NCT01394276|141687391|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||Exact binomial proportion test|||||||0.0003
71090430|NCT01394276|141687403|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.808|TWO_SIDED|95.0|-0.3|0.4|||t-test, 2 sided|||At Baseline: mean difference of scores of DAS28 between the two groups was calculated.||0.4|-0.3|0.8080
71090431|NCT01394276|141687403|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.4884|TWO_SIDED|95.0|-0.5|0.3|||t-test, 2 sided|||At Month 1: mean difference of scores of DAS28 between the two groups was calculated.||0.3|-0.5|0.4884
71090432|NCT01394276|141687403|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.3||||0.0947|TWO_SIDED|95.0|-0.7|0.1|||t-test, 2 sided|||At Month 2: mean difference of scores of DAS28 between the two groups was calculated.||0.1|-0.7|0.0947
71090433|NCT01394276|141687403|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.8181|TWO_SIDED|95.0|-0.4|0.3|||t-test, 2 sided|||At Month 4: mean difference of scores of DAS28 between the two groups was calculated.||0.3|-0.4|0.8181
71090434|NCT01394276|141687403|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.9721|TWO_SIDED|95.0|-0.4|0.3|||t-test, 2 sided|||At Month 6: mean difference of scores of DAS28 between the two groups was calculated.||0.3|-0.4|0.9721
71090435|NCT01394276|141687403|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1||||0.5832|TWO_SIDED|95.0|-0.3|0.5|||t-test, 2 sided|||At Month 12: mean difference of scores of DAS28 between the two groups was calculated.||0.5|-0.3|0.5832
71090436|NCT01394276|141687404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.5||||0.4211|TWO_SIDED|95.0|-5.1|12.2|||t-test, 2 sided|||At Baseline: mean difference of scores of fatigue between the two groups was calculated.||12.2|-5.1|0.4211
71090437|NCT01394276|141687404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.1||||0.6749|TWO_SIDED|95.0|-7.9|12.1|||t-test, 2 sided|||At Month 1: mean difference of scores of fatigue between the two groups was calculated.||12.1|-7.9|0.6749
71090438|NCT01394276|141687404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.4||||0.1817|TWO_SIDED|95.0|-3.0|15.9|||t-test, 2 sided|||At Month 2: mean difference of scores of fatigue between the two groups was calculated.||15.9|-3.0|0.1817
71090439|NCT01394276|141687404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.8||||0.5182|TWO_SIDED|95.0|-5.8|11.4|||t-test, 2 sided|||At Month 4: mean difference of scores of fatigue between the two groups was calculated.||11.4|-5.8|0.5182
71090440|NCT01394276|141687404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.7||||0.0025|TWO_SIDED|95.0|4.9|22.6|||t-test, 2 sided|||At Month 6: mean difference of scores of fatigue between the two groups was calculated.||22.6|4.9|0.0025
71090441|NCT01394276|141687404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.9||||0.354|TWO_SIDED|95.0|-4.4|12.1|||t-test, 2 sided|||At Month 12: mean difference of scores of fatigue between the two groups was calculated.||12.1|-4.4|0.3540
71090442|NCT01394276|141687405|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.7343|TWO_SIDED|95.0|-0.2|0.2|||t-test, 2 sided|||At Baseline: mean difference of scores of HAQ between the two groups was calculated.||0.2|-0.2|0.7343
71090443|NCT01394276|141687405|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.2||||0.1098|TWO_SIDED|95.0|-0.4|0.0|||t-test, 2 sided|||At Month 1: mean difference of scores of HAQ between the two groups was calculated.||0.0|-0.4|0.1098
71090444|NCT01394276|141687405|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.4932|TWO_SIDED|95.0|-0.3|0.2|||t-test, 2 sided|||At Month 2: mean difference of scores of HAQ between the two groups was calculated.||0.2|-0.3|0.4932
71090445|NCT01394276|141687405|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.2468|TWO_SIDED|95.0|-0.4|0.1|||t-test, 2 sided|||At Month 4: mean difference of scores of HAQ between the two groups was calculated.||0.1|-0.4|0.2468
71090446|NCT01394276|141687405|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.9639|TWO_SIDED|95.0|-0.2|0.2|||t-test, 2 sided|||At Month 6: mean difference of scores of HAQ between the two groups was calculated.||0.2|-0.2|0.9639
71090447|NCT01394276|141687405|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1||||0.6696|TWO_SIDED|95.0|-0.2|0.3|||t-test, 2 sided|||At Month 12: mean difference of scores of HAQ between the two groups was calculated.||0.3|-0.2|0.6696
71090448|NCT00471497|141687412|OTHER||Difference in response rate|22.1|||<|0.0001|TWO_SIDED|95.0|14.5|29.6|||Cochran-Mantel-Haenszel|||||29.6|14.5|<0.0001
71090449|NCT00471497|141687412|OTHER||Difference in response rate|20.4|||<|0.0001|TWO_SIDED|95.0|12.9|28.0|||Cochran-Mantel-Haenszel|||||28.0|12.9|<0.0001
71090450|NCT00471497|141687413|OTHER||Difference in response rate|14.8|||||TWO_SIDED|95.0|2.1|27.5||||||(Low)||27.5|2.1|
71090451|NCT00471497|141687413|OTHER||Difference in response rate|27.4|||||TWO_SIDED|95.0|14.6|40.2||||||(Low)||40.2|14.6|
71090452|NCT00471497|141687413|OTHER||Difference in response rate|27.7|||||TWO_SIDED|95.0|15.0|40.4||||||(Intermediate)||40.4|15.0|
71090453|NCT00471497|141687413|OTHER||Difference in response rate|17.2|||||TWO_SIDED|95.0|4.6|29.8||||||(Intermediate)||29.8|4.6|
71090454|NCT00471497|141687413|OTHER||Difference in response rate|24.4|||||TWO_SIDED|95.0|10.7|38.1||||||(High)||38.1|10.7|
71090455|NCT00471497|141687413|OTHER||Difference in response rate|15.4|||||TWO_SIDED|95.0|2.1|28.6||||||(High)||28.6|2.1|
71090456|NCT00471497|141687414|OTHER||Difference in response rate|21.3|||||TWO_SIDED|95.0|13.9|28.8||||||||28.8|13.9|
71090457|NCT00471497|141687414|OTHER||Difference in response rate|18.7|||||TWO_SIDED|95.0|11.3|26.0||||||||26.0|11.3|
71090458|NCT00471497|141687416|OTHER||Absolute difference|-1.6||||0.6987|TWO_SIDED|95.0|-9.8|6.6|||Cochran-Mantel-Haenszel|||||6.6|-9.8|0.6987
70946510|NCT01024036|141393482|SUPERIORITY_OR_OTHER||Difference of hemoglobin response rates|61.3||||0.0002|TWO_SIDED|95.0|28.3|85.1|||Cochran-Mantel-Haenszel||Difference in hemoglobin response rates is equal to hemoglobin response rate for siltuximab+best supportive care \[BSC\] arm minus hemoglobin response rate for Placebo+BSC arm.|||85.1|28.3|0.0002
70946511|NCT01024036|141393483|SUPERIORITY_OR_OTHER||Difference of hemoglobin response rates|41.9||||0.0195|TWO_SIDED|95.0|7.8|70.7|||Cochran-Mantel-Haenszel||Difference in hemoglobin response rates is equal to hemoglobin response rate for siltuximab+best supportive care \[BSC\] arm minus hemoglobin response rate for Placebo+BSC arm.|||70.7|7.8|0.0195
70946512|NCT03459612|141393489|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in Least Square (LS) means \< 4.4.|Difference in LS Means|0.98|||<|0.0001|TWO_SIDED|95.0|-0.43|2.39|||Mixed Models Analysis|||||2.39|-0.43|<0.0001
70946513|NCT03459612|141393489|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|LS Means|1.76|||<|0.0001|TWO_SIDED|95.0|0.32|3.2|||Mixed Models Analysis|||||3.20|0.32|<0.0001
70946514|NCT03459612|141393489|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|LS Means|4.98|||<|0.0001|TWO_SIDED|95.0|3.58|6.38|||Mixed Models Analysis|||||6.38|3.58|<0.0001
71090459|NCT01654276|141687450|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|TWO_SIDED||||||t-test, 2 sided|||||||0.66
71090460|NCT01991795|141687458|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.0378|TWO_SIDED|95.0|0.81|0.99||The hypothesis will be tested at the 4.96% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||0.99|0.81|0.0378
71090461|NCT01991795|141687459|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.7883|TWO_SIDED|95.0|0.88|1.18||The hypothesis will be tested at the 4.96% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.18|0.88|0.7883
71090462|NCT01991795|141687460|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0294|TWO_SIDED|95.0|0.71|0.98||The hypothesis will be tested at the 4.96% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||0.98|0.71|0.0294
71090463|NCT01991795|141687461|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0375|TWO_SIDED|95.0|0.64|0.99||The hypothesis will be tested at the 4.96% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||0.99|0.64|0.0375
71090464|NCT01991795|141687462|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.6846|TWO_SIDED|95.0|0.87|1.1|||Regression, Cox|||||1.10|0.87|0.6846
71090465|NCT01991795|141687463|SUPERIORITY||Hazard Ratio (HR)|2.32|||<|0.0001|TWO_SIDED|95.0|1.82|2.94|||Regression, Cox|||||2.94|1.82|<0.0001
71090466|NCT01991795|141687464|SUPERIORITY||Hazard Ratio (HR)|2.49|||<|0.0001|TWO_SIDED|95.0|2.02|3.07|||Regression, Cox|||||3.07|2.02|<0.0001
71090467|NCT01991795|141687465|SUPERIORITY||Hazard Ratio (HR)|2.41|||<|0.0001|TWO_SIDED|95.0|1.98|2.93|||Regression, Cox|||||2.93|1.98|<0.0001
71090468|NCT01991795|141687466|SUPERIORITY||Hazard Ratio (HR)|4.04|||<|0.0001|TWO_SIDED|95.0|3.32|4.92|||Regression, Cox|||||4.92|3.32|<0.0001
71090469|NCT04609514|141687480|SUPERIORITY||Median Difference (Final Values)|10.95||||0.51|TWO_SIDED||||||Wilcoxon Rank Sum Test|||||||0.51
71090470|NCT04609514|141687481|SUPERIORITY||||||<|0.001|||||||Wilcoxon Rank Sum Test|||||||<0.001
71090471|NCT04609514|141687486|SUPERIORITY|||||||0.39||||||A robust Yuen's test was conducted with an apriori threshold of 0.05 for statistical significance. No covariates were introduced in the model.|Robust Yuen's test|||||||0.39
71090472|NCT04609514|141687487|SUPERIORITY|||||||0.4|||||||Robust Yuen's test|||||||0.40
71090473|NCT04609514|141687488|SUPERIORITY|||||||0.478|||||||Wilcoxon rank sum test|Wilcoxon rank sum test with continuity correction.||||||0.478
71090474|NCT04609514|141687489|SUPERIORITY|||||||0.51|||||||Wilcoxon rank sum test|Wilcoxon rank sum test with continuity correction.||||||0.51
71090475|NCT04609514|141687491|SUPERIORITY||Odds Ratio (OR)|1.185||||0.8392|TWO_SIDED|95.0|0.23|6.119|||Regression, Logistic|||||6.119|0.23|0.8392
71090476|NCT04609514|141687492|SUPERIORITY|||||||1|||||||Pearson's Chi-squared test|Pearson's Chi-squared test with Yates' continuity correction.||||||1.00
71090477|NCT00909870|141687494|SUPERIORITY_OR_OTHER||Difference in proportions|6.5||||0.103|TWO_SIDED|95.0||||This p-value did not meet the prespecified threshold for statistical significance of \< 0.05|Chi-squared|Unadjusted||"H0: the proportion of responders in the Dermagraft group = the proportion of responders in the Control group.~HA: the proportion of responders in the Dermagraft group ≠ the proportion of responders in the Control group.~The proportion of responders in the Dermagraft group was compared with the proportion of responders in the control group using the uncorrected chi-square test for 2x2 contingency tables. The difference between the groups was expected to be 13%."||||0.1030
71090478|NCT00909870|141687495|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|6.0||||0.4046||95.0||||This p-value did not meet the prespecified threshold for statistical significance of \< 0.05|Log Rank|||||||0.4046
71090479|NCT00909870|141687496|SUPERIORITY_OR_OTHER||Difference in proportions|10.0||||0.0239||95.0||||Unadjusted|Chi-squared|Unadjusted||Pre-specified subgroup analysis of the primary endpoint||||0.0239
71090480|NCT01232283|141687509|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|23.0|||<|0.0001|TWO_SIDED|95.0|16.3|29.6|||Chi-squared|||||29.6|16.3|<0.0001
71090481|NCT01232283|141687510|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|16.1|||<|0.0001|TWO_SIDED|95.0|10.2|21.9|||Chi-squared|||||21.9|10.2|<0.0001
71090482|NCT01232283|141687511|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-42.15|||<|0.0001|TWO_SIDED|95.0|-51.11|-33.2|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||-33.20|-51.11|<0.0001
71090483|NCT01232283|141687512|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-34.8|||<|0.0001|TWO_SIDED|95.0|-42.4|-27.2|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||-27.2|-42.4|<0.0001
71127641|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|||||TWO_SIDED|95.0|0.13|0.51||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.51|0.13|
71127642|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|||||TWO_SIDED|95.0|-0.11|0.27||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.27|-0.11|
71127643|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|||||TWO_SIDED|95.0|-0.04|0.34||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.34|-0.04|
71127644|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.13|0.25||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.25|-0.13|
71127645|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|||||TWO_SIDED|95.0|0.13|0.52||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.52|0.13|
71127646|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|||||TWO_SIDED|95.0|-0.12|0.27||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.27|-0.12|
71127647|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|||||TWO_SIDED|95.0|-0.05|0.35||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.35|-0.05|
71127648|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.08|0.31||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.31|-0.08|
70946515|NCT03459612|141393490|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|Difference in LS Means|-0.12|||<|0.0001|TWO_SIDED|95.0|-1.28|1.04|||Mixed Models Analysis|||||1.04|-1.28|<0.0001
71127649|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|||||TWO_SIDED|95.0|0.28|0.73||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.73|0.28|
71127650|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|||||TWO_SIDED|95.0|-0.05|0.4||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.40|-0.05|
71127651|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-0.06|0.4||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.40|-0.06|
71127652|NCT01393639|141760276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|||||TWO_SIDED|95.0|-0.01|0.44||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.44|-0.01|
71127653|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41|||||TWO_SIDED|95.0|-0.78|-0.04||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.04|-0.78|
71127654|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75|||||TWO_SIDED|95.0|-1.12|-0.39||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.39|-1.12|
71127655|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81|||||TWO_SIDED|95.0|-1.18|-0.44||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.44|-1.18|
71127656|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.11|||||TWO_SIDED|95.0|-1.48|-0.74||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.74|-1.48|
71127657|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|||||TWO_SIDED|95.0|-0.72|0.02||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.02|-0.72|
70946516|NCT03459612|141393490|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|Difference in LS Means|-0.32|||<|0.0001|TWO_SIDED|95.0|-1.51|0.88|||Mixed Models Analysis|||||0.88|-1.51|<0.0001
71127658|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.83|||||TWO_SIDED|95.0|-1.19|-0.46||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.46|-1.19|
70946517|NCT03459612|141393490|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|Difference in LS Means|4.31|||<|0.0001|TWO_SIDED|95.0|3.17|5.45|||Mixed Models Analysis|||||5.45|3.17|<0.0001
70946518|NCT03459612|141393491|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|Differnce in LS Means|-0.97|||<|0.0001|TWO_SIDED|95.0|-2.3|0.36|||Mixed Models Analysis|||||0.36|-2.30|<0.0001
71127659|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43|||||TWO_SIDED|95.0|-0.85|0.0||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.00|-0.85|
71127660|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.73|||||TWO_SIDED|95.0|-1.15|-0.31||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.31|-1.15|
71127661|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.95|||||TWO_SIDED|95.0|-1.37|-0.52||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.52|-1.37|
71127662|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.96|||||TWO_SIDED|95.0|-1.39|-0.54||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.54|-1.39|
71127663|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|||||TWO_SIDED|95.0|-0.67|0.18||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.18|-0.67|
71127664|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.91|||||TWO_SIDED|95.0|-1.33|-0.49||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.49|-1.33|
71127665|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44|||||TWO_SIDED|95.0|-0.9|0.02||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.02|-0.90|
70858208|NCT02106923|141202474|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|98.71|STANDARD_ERROR_OF_MEAN|1.02|<|0.0001|TWO_SIDED|90.0|94.77|102.8|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)|||102.80|94.77|<0.0001
70946519|NCT03459612|141393491|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|Difference in LS Means|-1.04|||<|0.0001|TWO_SIDED|95.0|-2.4|0.32|||Mixed Models Analysis|||||0.32|-2.40|<0.0001
71090484|NCT01232283|141687513|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|35.8|||<|0.0001|TWO_SIDED|95.0|26.9|44.7|||Chi-squared|||||44.7|26.9|< 0.0001
71090485|NCT01232283|141687514|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-21.3|||<|0.0001|TWO_SIDED|95.0|-28.4|-14.2|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||-14.2|-28.4|<0.0001
71090486|NCT01232283|141687515|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.0|||<|0.0001|TWO_SIDED|95.0|-5.3|-2.8|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||-2.8|-5.3|<0.0001
71090487|NCT01232283|141687516|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.63||||0.0078|TWO_SIDED|95.0|0.69|4.56|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||4.56|0.69|0.0078
71090488|NCT01232283|141687517|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|14.2|||<|0.0001|TWO_SIDED|95.0|8.5|20.0|||Chi-squared|||||20.0|8.5|<0.0001
71090489|NCT01232283|141687518|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|7.7|||<|0.0001|TWO_SIDED|95.0|3.408|17.399|||Log Rank|||||17.399|3.408|<0.0001
71090490|NCT00402831|141687523|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was declared when the lower bounds of the 95% confidence interval (CI) of the group difference in response rates was greater than -10%.|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-2.5|2.6||||||Measles difference||2.6|-2.5|
70946520|NCT03459612|141393491|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|Difference in LS Means|4.05|||<|0.0001|TWO_SIDED|95.0|2.73|5.38|||Mixed Models Analysis|||||5.38|2.73|<0.0001
71090491|NCT00402831|141687523|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was declared when the lower bounds of the 95% confidence interval (CI) of the group difference in response rates was greater than -10%.|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-3.0|3.3||||||Mumps difference||3.3|-3.0|
71127666|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87|||||TWO_SIDED|95.0|-1.32|-0.41||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.41|-1.32|
71127667|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.07|||||TWO_SIDED|95.0|-1.53|-0.62||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.62|-1.53|
71127668|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.05|||||TWO_SIDED|95.0|-1.51|-0.6||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.60|-1.51|
70946521|NCT03459612|141393492|SUPERIORITY||Differences of Least Square Mean|0.28|||||TWO_SIDED|95.0|-0.15|0.7||||||||0.70|-0.15|
70946522|NCT03459612|141393492|SUPERIORITY||Difference of Least Square Means|0.66|||||TWO_SIDED|95.0|0.22|1.1||||||||1.10|0.22|
70946523|NCT03459612|141393492|SUPERIORITY||Difference of Least Square Means|0.81|||||TWO_SIDED|95.0|0.39|1.24||||||||1.24|0.39|
70946524|NCT03459612|141393493|SUPERIORITY||Difference of Least Square Means|0.48|||||TWO_SIDED|95.0|0.0|0.96||||||||0.96|0.00|
70946525|NCT03459612|141393493|SUPERIORITY||Differnce of Least Square Means|0.34|||||TWO_SIDED|95.0|-0.14|0.82||||||||0.82|-0.14|
70946526|NCT03459612|141393493|SUPERIORITY||Difference of Least Square Means|1.29|||||TWO_SIDED|95.0|0.81|1.78||||||||1.78|0.81|
70946527|NCT03459612|141393494|SUPERIORITY||Difference of Least Square Means|-0.58|||||TWO_SIDED|95.0|-1.1|-0.06||||||||-0.06|-1.10|
70946528|NCT03459612|141393494|SUPERIORITY||Difference of Least Square Means|-0.4|||||TWO_SIDED|95.0|-0.89|0.09||||||||0.09|-0.89|
71090492|NCT00402831|141687523|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was declared when the lower bounds of the 95% confidence interval (CI) of the group difference in response rates was greater than -10%.|Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-2.3|4.1||||||Rubella difference||4.1|-2.3|
71090493|NCT00402831|141687523|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was declared when the lower bounds of the 95% confidence interval (CI) of the group difference in response rates was greater than -10%.|Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-2.1|4.1||||||Varicella||4.1|-2.1|
71090494|NCT04773028|141687536|OTHER||Mean Difference (Final Values)|-93054.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71090495|NCT03043053|141687537|OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|95.0|-1.4|1.3||||||||1.3|-1.4|
70946529|NCT03459612|141393494|SUPERIORITY||Difference of Least Square Means|0.44|||||TWO_SIDED|95.0|-0.09|0.96||||||||0.96|-0.09|
71090496|NCT03043053|141687538|OTHER||Mean Difference (Final Values)|-29.7|||||TWO_SIDED|95.0|-141.9|82.6|||||Controlled for lean mass. Reported values are outputted by STATA.|||82.6|-141.9|
71090497|NCT03043053|141687539|OTHER||Mean Difference (Final Values)|196.0|||||TWO_SIDED|95.0|-1036.0|1428.0||||||||1428|-1036|
71090498|NCT03043053|141687540|OTHER||Mean Difference (Final Values)|-152.0|||||TWO_SIDED|95.0|-302.3|-1.7||||||||-1.7|-302.3|
71090499|NCT02966834|141687571|OTHER||Mean Difference (Net)|-0.47|||||TWO_SIDED|95.0|-1.75|0.82||||||||0.82|-1.75|
71090500|NCT02966834|141687571|OTHER||Mean Difference (Net)|-0.88|||||TWO_SIDED|95.0|-2.07|0.31||||||||0.31|-2.07|
71090501|NCT02966834|141687571|OTHER||Mean Difference (Net)|-0.88|||||TWO_SIDED|95.0|-2.03|0.28||||||||0.28|-2.03|
71090502|NCT02966834|141687571|OTHER||Mean Difference (Net)|-1.13|||||TWO_SIDED|95.0|-2.29|0.03||||||||0.03|-2.29|
71090503|NCT02966834|141687571|OTHER||Mean Difference (Net)|-0.53|||||TWO_SIDED|95.0|-1.71|0.65||||||||0.65|-1.71|
71090504|NCT02966834|141687572|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-1.9|2.3|||||Symptoms|||2.3|-1.9|
71090505|NCT02966834|141687572|OTHER||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|-1.5|2.5|||||Symptoms|||2.5|-1.5|
71090506|NCT02966834|141687572|OTHER||Mean Difference (Net)|-1.1|||||TWO_SIDED|95.0|-3.1|0.8|||||Symptoms|||0.8|-3.1|
71090507|NCT02966834|141687572|OTHER||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-1.8|2.0|||||Symptoms|||2.0|-1.8|
71090508|NCT02966834|141687572|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-2.0|1.9|||||Symptoms|||1.9|-2.0|
71090509|NCT02966834|141687572|OTHER||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|-1.3|2.2|||||Itch|||2.2|-1.3|
71127669|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43|||||TWO_SIDED|95.0|-0.89|0.03||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.03|-0.89|
71127670|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.04|||||TWO_SIDED|95.0|-1.5|-0.59||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.59|-1.50|
71127671|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|||||TWO_SIDED|95.0|-1.0|-0.03||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.03|-1.00|
70946530|NCT03459612|141393495|SUPERIORITY||Difference in Least Square Means|0.0|||||TWO_SIDED|95.0|-1.61|1.62||||||||1.62|-1.61|
70946531|NCT03459612|141393495|SUPERIORITY||Difference in Lease Square Means|-0.74|||||TWO_SIDED|95.0|-2.49|1.01||||||||1.01|-2.49|
70946532|NCT03459612|141393495|SUPERIORITY||Difference in Least Square Means|-0.72|||||TWO_SIDED|95.0|-2.32|0.89||||||||0.89|-2.32|
70946533|NCT03459612|141393496|SUPERIORITY||Difference of Least Square Means|-1.79|||||TWO_SIDED|95.0|-3.52|-0.06||||||||-0.06|-3.52|
70946534|NCT03459612|141393496|SUPERIORITY||Difference in Least Square Means|-0.29|||||TWO_SIDED|95.0|-2.0|1.42||||||||1.42|-2.00|
70946535|NCT03459612|141393496|SUPERIORITY||Difference in Least Square Means|-3.81|||||TWO_SIDED|95.0|-5.53|-2.08||||||||-2.08|-5.53|
70946536|NCT03459612|141393497|SUPERIORITY||Difference of Least Square Means|-0.28|||||TWO_SIDED|95.0|-1.71|1.15||||||||1.15|-1.71|
70946537|NCT03459612|141393497|SUPERIORITY||Difference of Least Square Means|-0.31|||||TWO_SIDED|95.0|-1.71|1.08||||||||1.08|-1.71|
70946538|NCT03459612|141393497|SUPERIORITY||Difference of Least Square Means|-2.7|||||TWO_SIDED|95.0|-4.13|-1.27||||||||-1.27|-4.13|
70946539|NCT03459612|141393498|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_DEVIATION|0.3||0.6875|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.6875
70946540|NCT03459612|141393498|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.27||0.375|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.3750
70946541|NCT03459612|141393498|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|1.0||0.0115|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.0115
70946542|NCT03459612|141393499|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|0.42||0.1563|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.1563
70946543|NCT03459612|141393499|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.44||0.5938|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.5938
70946544|NCT03459612|141393499|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_DEVIATION|0.54||0.0938|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.0938
70946545|NCT03459612|141393500|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_DEVIATION|0.56||0.125|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.1250
70946546|NCT03459612|141393500|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_DEVIATION|0.94||0.959|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.9590
70946547|NCT03459612|141393500|SUPERIORITY||Mean Difference (Final Values)|0.46|STANDARD_DEVIATION|1.76||0.0097|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.0097
70858209|NCT02106923|141202474|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|103.9|STANDARD_ERROR_OF_MEAN|1.06||0.0021|TWO_SIDED|90.0|94.09|114.74|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)|||114.74|94.09|0.0021
70858210|NCT03485495|141202475|SUPERIORITY|||||||0.007||||||A priori threshold for statistical significance is split evenly between primary and secondary endpoints. α=0.025.|t-test, 2 sided|||This analysis applies to ∆ between baseline and after 12 weeks row.||||0.007
70946548|NCT01817712|141393511|SUPERIORITY||Odds Ratio (OR)|2.14|||<|0.001|TWO_SIDED|95.0|1.46|3.14|||Regression, Logistic|||||3.14|1.46|<0.001
70946549|NCT01817712|141393512|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|Site used as strata||||||0.004
71090510|NCT02966834|141687572|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.8|1.3|||||Itch|||1.3|-1.8|
71090511|NCT02966834|141687572|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.9|1.2|||||Itch|||1.2|-1.9|
71090512|NCT02966834|141687572|OTHER||Mean Difference (Net)|-1.0|||||TWO_SIDED|95.0|-2.6|0.5|||||Itch|||0.5|-2.6|
71090513|NCT02966834|141687572|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.9|1.3|||||Itch|||1.3|-1.9|
71090514|NCT02966834|141687572|OTHER||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-4.5|3.2|||||Fatigue|||3.2|-4.5|
71090515|NCT02966834|141687572|OTHER||Median Difference (Net)|0.7|||||TWO_SIDED|95.0|-2.8|4.2|||||Fatigue|||4.2|-2.8|
71090516|NCT02966834|141687572|OTHER||Mean Difference (Net)|3.5|||||TWO_SIDED|95.0|0.0|7.0|||||Fatigue|||7.0|0.0|
71090517|NCT02966834|141687572|OTHER||Mean Difference (Net)|1.7|||||TWO_SIDED|95.0|-1.8|5.1|||||Fatigue|||5.1|-1.8|
71090518|NCT02966834|141687572|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-3.6|3.6|||||Fatigue|||3.6|-3.6|
71090519|NCT02966834|141687572|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-2.5|2.6|||||Cognitive|||2.6|-2.5|
71090520|NCT02966834|141687572|OTHER||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-2.9|1.7|||||Cognitive|||1.7|-2.9|
71090521|NCT02966834|141687572|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-2.1|2.5|||||Cognitive|||2.5|-2.1|
71090522|NCT02966834|141687572|OTHER||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|-1.8|2.8|||||Cognitive|||2.8|-1.8|
71090523|NCT02966834|141687572|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-2.2|2.5|||||Cognitive|||2.5|-2.2|
71090524|NCT02966834|141687572|OTHER||Mean Difference (Net)|-0.9|||||TWO_SIDED|95.0|-2.1|0.4|||||Emotional|||0.4|-2.1|
71090525|NCT02966834|141687572|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-0.9|1.3|||||Emotional|||1.3|-0.9|
71090526|NCT02966834|141687572|OTHER||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-1.2|1.1|||||Emotional|||1.1|-1.2|
71090527|NCT02966834|141687572|OTHER||Mean Difference (Net)|-0.8|||||TWO_SIDED|95.0|-1.9|0.3|||||Emotional|||0.3|-1.9|
71090528|NCT02966834|141687572|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-1.2|1.1|||||Emotional|||1.1|-1.2|
71090529|NCT02966834|141687572|OTHER||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-2.4|3.0|||||Social|||3.0|-2.4|
71090530|NCT02966834|141687572|OTHER||Mean Difference (Net)|1.2|||||TWO_SIDED|95.0|-1.3|3.7|||||Social|||3.7|-1.3|
71090531|NCT02966834|141687572|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-2.3|2.7|||||Social|||2.7|-2.3|
71090532|NCT02966834|141687572|OTHER||Mean Difference (Net)|-2.4|||||TWO_SIDED|95.0|-4.8|0.1|||||Social|||0.1|-4.8|
71090533|NCT02966834|141687572|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-2.8|2.4|||||Social|||2.4|-2.8|
71090534|NCT02966834|141687573|OTHER||Mean Difference (Net)|-106.8|||||TWO_SIDED|95.0|-251.7|38.2||||||||38.2|-251.7|
71090535|NCT02966834|141687573|OTHER||Mean Difference (Net)|-87.4|||||TWO_SIDED|95.0|-198.5|23.8||||||||23.8|-198.5|
71090536|NCT02966834|141687573|OTHER||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-125.6|126.5||||||||126.5|-125.6|
71090537|NCT02966834|141687573|OTHER||Mean Difference (Net)|-78.3|||||TWO_SIDED|95.0|-211.5|54.8||||||||54.8|-211.5|
71090538|NCT02966834|141687573|OTHER||Mean Difference (Net)|-30.0|||||TWO_SIDED|95.0|-170.7|110.7||||||||110.7|-170.7|
71090539|NCT02966834|141687575|OTHER||Mean Difference (Net)|-21.4|||||TWO_SIDED|95.0|-58.4|15.5||||||||15.5|-58.4|
71090540|NCT02966834|141687575|OTHER||Mean Difference (Net)|-12.7|||||TWO_SIDED|95.0|-41.9|16.4||||||||16.4|-41.9|
71090541|NCT02966834|141687575|OTHER||Mean Difference (Net)|-15.0|||||TWO_SIDED|95.0|-49.9|20.0||||||||20.0|-49.9|
71090542|NCT02966834|141687575|OTHER||Mean Difference (Net)|-26.5|||||TWO_SIDED|95.0|-63.3|10.4||||||||10.4|-63.3|
71090543|NCT02966834|141687575|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-36.7|37.1||||||||37.1|-36.7|
71090544|NCT02966834|141687576|OTHER||Mean Difference (Net)|-20.0|||||TWO_SIDED|95.0|-52.73|12.74||||||||12.74|-52.73|
70946550|NCT01817712|141393513|OTHER|Longitudinal analysis of PCL-5 (change from baseline)|Mean Difference (Net)|-1.9||||0.07|TWO_SIDED|95.0|-3.91|0.12|||Mixed Models Analysis|||||0.12|-3.91|0.07
71090545|NCT02966834|141687576|OTHER||Mean Difference (Net)|-24.7|||||TWO_SIDED|95.0|-50.8|1.39||||||||1.39|-50.80|
71090546|NCT02966834|141687576|OTHER||Mean Difference (Net)|-22.61|||||TWO_SIDED|95.0|-53.39|8.16||||||||8.16|-53.39|
71090547|NCT02966834|141687576|OTHER||Mean Difference (Net)|-31.67|||||TWO_SIDED|95.0|-63.44|0.09||||||||0.09|-63.44|
71090548|NCT02966834|141687576|OTHER||Mean Difference (Net)|-5.79|||||TWO_SIDED|95.0|-38.33|26.74||||||||26.74|-38.33|
71090549|NCT02966834|141687577|OTHER||Mean Difference (Net)|-106.0|||||TWO_SIDED|95.0|-205.1|-6.8||||||||-6.8|-205.1|
71090550|NCT02966834|141687577|OTHER||Mean Difference (Net)|-65.5|||||TWO_SIDED|95.0|-148.5|17.6||||||||17.6|-148.5|
71090551|NCT02966834|141687577|OTHER||Mean Difference (Net)|-42.8|||||TWO_SIDED|95.0|-136.5|50.9||||||||50.9|-136.5|
71090552|NCT02966834|141687577|OTHER||Mean Difference (Net)|-65.8|||||TWO_SIDED|95.0|-161.2|29.5||||||||29.5|-161.2|
71090553|NCT02966834|141687577|OTHER||Mean Difference (Net)|-54.1|||||TWO_SIDED|95.0|-153.6|45.3||||||||45.3|-153.6|
71090554|NCT02966834|141687578|OTHER||Mean Difference (Net)|-6.099|||||TWO_SIDED|95.0|-11.929|-0.268||||||||-0.268|-11.929|
71090555|NCT02966834|141687578|OTHER||Mean Difference (Net)|-2.337|||||TWO_SIDED|95.0|-6.962|2.289||||||||2.289|-6.962|
71090556|NCT02966834|141687578|OTHER||Mean Difference (Net)|-2.232|||||TWO_SIDED|95.0|-7.679|3.215||||||||3.215|-7.679|
71090557|NCT02966834|141687578|OTHER||Mean Difference (Net)|-1.492|||||TWO_SIDED|95.0|-7.413|4.43||||||||4.430|-7.413|
71090558|NCT02966834|141687578|OTHER||Mean Difference (Net)|5.236|||||TWO_SIDED|95.0|-0.591|11.063||||||||11.063|-0.591|
71090559|NCT02966834|141687579|OTHER||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-2.7|1.6||||||||1.6|-2.7|
71090560|NCT02966834|141687579|OTHER||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-1.5|2.1||||||||2.1|-1.5|
71090561|NCT02966834|141687579|OTHER||Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|-1.2|2.7||||||||2.7|-1.2|
71090562|NCT02966834|141687579|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-2.1|2.0||||||||2.0|-2.1|
71090563|NCT02966834|141687579|OTHER||Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|-1.5|2.9||||||||2.9|-1.5|
71090564|NCT02966834|141687580|OTHER||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.08|0.04||||||||0.04|-0.08|
71090565|NCT02966834|141687580|OTHER||Mean Difference (Net)|-0.04|||||TWO_SIDED|95.0|-0.09|0.01||||||||0.01|-0.09|
71090566|NCT02966834|141687580|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.06|0.05||||||||0.05|-0.06|
71090567|NCT02966834|141687580|OTHER||Mean Difference (Net)|-0.03|||||TWO_SIDED|95.0|-0.09|0.02||||||||0.02|-0.09|
71090568|NCT02966834|141687580|OTHER||Mean Difference (Net)|-0.04|||||TWO_SIDED|95.0|-0.1|0.02||||||||0.02|-0.10|
71090569|NCT02966834|141687581|OTHER||Mean Difference (Net)|0.15|||||TWO_SIDED|95.0|-0.33|0.63||||||||0.63|-0.33|
71090570|NCT02966834|141687581|OTHER||Mean Difference (Net)|-0.11|||||TWO_SIDED|95.0|-0.51|0.3||||||||0.30|-0.51|
71090571|NCT02966834|141687581|OTHER||Mean Difference (Net)|0.12|||||TWO_SIDED|95.0|-0.34|0.58||||||||0.58|-0.34|
71090572|NCT02966834|141687581|OTHER||Mean Difference (Net)|-0.08|||||TWO_SIDED|95.0|-0.54|0.38||||||||0.38|-0.54|
71090573|NCT02966834|141687581|OTHER||Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-0.54|0.41||||||||0.41|-0.54|
70946551|NCT00097669|141393514|SUPERIORITY|"We used Kaplan-Meier methods to construct cumulative time-to-event curves for the two groups, with a comparison by use of the log-rank test.~We used a Cox proportional hazard model analysis to control for any potential imbalance in baseline characteristics and follow-up between the two groups."|Risk Ratio (RR)|0.91||||0.05|TWO_SIDED|95.0|0.82|1.0|||Log Rank|||||1.00|0.82|0.05
71090574|NCT02966834|141687591|OTHER||Odds Ratio (OR)|2.89|||||TWO_SIDED|95.0|0.69|12.02|||||Analysis was performed using Logistic regression. No covariates were used.|||12.02|0.69|
71090575|NCT02966834|141687591|OTHER||Odds Ratio (OR)|1.56|||||TWO_SIDED|95.0|0.48|5.02|||||Analysis was performed using Logistic regression. No covariates were used.|||5.02|0.48|
71090576|NCT02966834|141687591|OTHER||Odds Ratio (OR)|3.0|||||TWO_SIDED|95.0|0.84|10.76|||||Analysis was performed using Logistic regression. No covariates were used.|||10.76|0.84|
71090577|NCT02966834|141687591|OTHER||Odds Ratio (OR)|3.0|||||TWO_SIDED|95.0|0.84|10.76|||||Analysis was performed using Logistic regression. No covariates were used.|||10.76|0.84|
71090578|NCT02966834|141687591|OTHER||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.43|4.13|||||Analysis was performed using Logistic regression. No covariates were used.|||4.13|0.43|
71090579|NCT02966834|141687592|OTHER||Odds Ratio (OR)|1.36|||||TWO_SIDED|95.0|0.41|4.47|||||Analysis was performed using Logistic regression. No covariates were used.|||4.47|0.41|
71090580|NCT02966834|141687592|OTHER||Odds Ratio (OR)|3.18|||||TWO_SIDED|95.0|0.95|10.65|||||Analysis was performed using Logistic regression. No covariates were used.|||10.65|0.95|
71090581|NCT02966834|141687592|OTHER||Odds Ratio (OR)|1.85|||||TWO_SIDED|95.0|0.62|5.53|||||Analysis was performed using Logistic regression. No covariates were used.|||5.53|0.62|
71090582|NCT02966834|141687592|OTHER||Odds Ratio (OR)|2.27|||||TWO_SIDED|95.0|0.74|6.92|||||Analysis was performed using Logistic regression. No covariates were used.|||6.92|0.74|
71090583|NCT02966834|141687592|OTHER||Odds Ratio (OR)|2.12|||||TWO_SIDED|95.0|0.69|6.51|||||Analysis was performed using Logistic regression. No covariates were used.|||6.51|0.69|
71090584|NCT02966834|141687593|OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.27|3.04|||||Analysis was performed using Logistic regression. No covariates were used.|||3.04|0.27|
71090585|NCT02966834|141687593|OTHER||Odds Ratio (OR)|2.25|||||TWO_SIDED|95.0|0.73|6.91|||||Analysis was performed using Logistic regression. No covariates were used.|||6.91|0.73|
71090586|NCT02966834|141687593|OTHER||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.35|3.08|||||Analysis was performed using Logistic regression. No covariates were used.|||3.08|0.35|
71090587|NCT02966834|141687593|OTHER||Odds Ratio (OR)|2.17|||||TWO_SIDED|95.0|0.73|6.42|||||Analysis was performed using Logistic regression. No covariates were used.|||6.42|0.73|
71090588|NCT02966834|141687593|OTHER||Odds Ratio (OR)|2.0|||||TWO_SIDED|95.0|0.67|5.99|||||Analysis was performed using Logistic regression. No covariates were used.|||5.99|0.67|
71090589|NCT02966834|141687594|OTHER||Mean Difference (Net)|18.21|||||TWO_SIDED|95.0|-2.59|39.0||||||||39.00|-2.59|
71090590|NCT02966834|141687594|OTHER||Mean Difference (Net)|11.05|||||TWO_SIDED|95.0|-7.42|29.53||||||||29.53|-7.42|
71090591|NCT02966834|141687594|OTHER||Mean Difference (Net)|18.44|||||TWO_SIDED|95.0|0.82|36.06||||||||36.06|0.82|
71090592|NCT02966834|141687594|OTHER||Mean Difference (Net)|25.48|||||TWO_SIDED|95.0|7.0|43.95||||||||43.95|7.00|
71090593|NCT02966834|141687594|OTHER||Mean Difference (Net)|13.26|||||TWO_SIDED|95.0|-5.47|31.99||||||||31.99|-5.47|
71090594|NCT02966834|141687595|OTHER||Mean Difference (Net)|14.99|||||TWO_SIDED|95.0|-5.13|35.1||||||||35.10|-5.13|
71090595|NCT02966834|141687595|OTHER||Mean Difference (Net)|6.97|||||TWO_SIDED|95.0|-10.9|24.84||||||||24.84|-10.90|
71090596|NCT02966834|141687595|OTHER||Mean Difference (Net)|11.78|||||TWO_SIDED|95.0|-5.27|28.82||||||||28.82|-5.27|
71090597|NCT02966834|141687595|OTHER||Mean Difference (Net)|21.83|||||TWO_SIDED|95.0|3.96|39.7||||||||39.70|3.96|
71090598|NCT02966834|141687595|OTHER||Mean Difference (Net)|21.58|||||TWO_SIDED|95.0|3.46|39.69||||||||39.69|3.46|
71090599|NCT02966834|141687596|OTHER||Mean Difference (Net)|6.15|||||TWO_SIDED|95.0|-14.76|27.06||||||||27.06|-14.76|
71090600|NCT02966834|141687596|OTHER||Mean Difference (Net)|7.26|||||TWO_SIDED|95.0|-11.32|25.84||||||||25.84|-11.32|
71090601|NCT02966834|141687596|OTHER||Mean Difference (Net)|9.13|||||TWO_SIDED|95.0|-8.59|26.85||||||||26.85|-8.59|
71090602|NCT02966834|141687596|OTHER||Mean Difference (Net)|19.94|||||TWO_SIDED|95.0|1.36|38.51||||||||38.51|1.36|
71090603|NCT02966834|141687596|OTHER||Mean Difference (Net)|27.04|||||TWO_SIDED|95.0|8.2|45.87||||||||45.87|8.20|
71090604|NCT02966834|141687597|OTHER||Mean Difference (Net)|-0.27|||||TWO_SIDED|95.0|-1.46|0.92||||||||0.92|-1.46|
71090605|NCT02966834|141687597|OTHER||Mean Difference (Net)|-0.48|||||TWO_SIDED|95.0|-1.58|0.62||||||||0.62|-1.58|
71090606|NCT02966834|141687597|OTHER||Mean Difference (Net)|-0.46|||||TWO_SIDED|95.0|-1.53|0.61||||||||0.61|-1.53|
71090607|NCT02966834|141687597|OTHER||Mean Difference (Net)|-0.96|||||TWO_SIDED|95.0|-2.03|0.12||||||||0.12|-2.03|
71090608|NCT02966834|141687597|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.4|0.8||||||||0.80|-1.40|
71090609|NCT02966834|141687598|OTHER||Mean Difference (Net)|-0.39|||||TWO_SIDED|95.0|-1.49|0.71||||||||0.71|-1.49|
71090610|NCT02966834|141687598|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-1.41|0.61||||||||0.61|-1.41|
71090611|NCT02966834|141687598|OTHER||Mean Difference (Net)|-0.26|||||TWO_SIDED|95.0|-1.24|0.72||||||||0.72|-1.24|
71090612|NCT02966834|141687598|OTHER||Mean Difference (Net)|-0.42|||||TWO_SIDED|95.0|-1.39|0.56||||||||0.56|-1.39|
71090613|NCT02966834|141687598|OTHER||Mean Difference (Net)|-0.29|||||TWO_SIDED|95.0|-1.28|0.7||||||||0.70|-1.28|
71090614|NCT02966834|141687599|OTHER||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.7|0.5|||||Duration|||0.5|-0.7|
71090615|NCT02966834|141687599|OTHER||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-0.2|0.9|||||Duration|||0.9|-0.2|
71090616|NCT02966834|141687599|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-1.0|0.1|||||Duration|||0.1|-1.0|
70858211|NCT03485495|141202476|SUPERIORITY|||||||0.0272||||||A priori threshold for statistical significance is split evenly between primary and secondary endpoints. α=0.025.|Fisher Exact|||||||0.0272
70858212|NCT03485495|141202477|SUPERIORITY|||||||0.8762|||||||t-test, 2 sided|||This analysis applies to ∆ between baseline and after 12 weeks row.||||0.8762
70946552|NCT00097669|141393514|SUPERIORITY||Hazard Ratio (HR)|0.9|||<|0.05|TWO_SIDED|95.0|0.81|1.0|||Regression, Cox|Analysis before adjusting for any potential imbalance in the baseline characteristics and follow-up duration between the groups.||||1.00|0.81|<0.05
70946553|NCT00097669|141393514|SUPERIORITY||Hazard Ratio (HR)|0.91|||<|0.05|TWO_SIDED|95.0|0.81|1.03|||Regression, Cox|Analysis after adjusting for any potential imbalance in the baseline characteristics and follow-up duration between the groups.||||1.03|0.81|<0.05
70858213|NCT03485495|141202478|SUPERIORITY|||||||0.2082|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and after 12 weeks row.||||0.2082
70858214|NCT03485495|141202479|SUPERIORITY|||||||0.0038||||||"The p-value associated with treatment\*visit interaction between Divaza and Placebo treatment groups. Model includes cuff test status, treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to NO-3 data.||||0.0038
70946554|NCT01468077|141393610|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0164|||||TWO_SIDED|95.0|-0.2685|0.2988|||||The CI (confidence interval) is calculated by Exact method based on binomial distribution.|||0.2988|-0.2685|
70858215|NCT03485495|141202479|SUPERIORITY|||||||0.0018||||||"The p-value associated with treatment\*visit interaction between Divaza and Placebo treatment groups. Model includes cuff test status, treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to NO-2 data.||||0.0018
70946555|NCT03024996|141393628|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.495|TWO_SIDED|95.0|0.75|1.15|||Log Rank|||||1.15|0.75|0.4950
71127672|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.91|||||TWO_SIDED|95.0|-1.4|-0.43||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.43|-1.40|
71127673|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.29|||||TWO_SIDED|95.0|-1.77|-0.8||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.80|-1.77|
71127674|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-1.69|-0.72||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.72|-1.69|
71127675|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|||||TWO_SIDED|95.0|-0.98|-0.01||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.01|-0.98|
71127676|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.21|||||TWO_SIDED|95.0|-1.69|-0.73||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.73|-1.69|
71127677|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.41|||||TWO_SIDED|95.0|0.04|0.78||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.78|0.04|
71127678|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|||||TWO_SIDED|95.0|-0.29|0.44||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.44|-0.29|
71127679|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.35|0.38||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.38|-0.35|
71127680|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|||||TWO_SIDED|95.0|-0.65|0.08||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.08|-0.65|
71127681|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.48|||||TWO_SIDED|95.0|0.06|0.91||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.91|0.06|
71127682|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|||||TWO_SIDED|95.0|-0.24|0.6||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.60|-0.24|
71127683|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.46|0.38||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.38|-0.46|
71127684|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|||||TWO_SIDED|95.0|-0.48|0.37||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.37|-0.48|
71127685|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.61|||||TWO_SIDED|95.0|0.15|1.06||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.06|0.15|
71127686|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|||||TWO_SIDED|95.0|-0.28|0.63||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.63|-0.28|
70946556|NCT03024996|141393629|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8868||95.0|0.67|1.42|||Log Rank|||||1.42|0.67|0.8868
70946557|NCT03024996|141393630|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.201|TWO_SIDED|95.0|0.63|1.1|||Log Rank|||||1.10|0.63|0.2010
70946558|NCT03024996|141393631|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.2811|TWO_SIDED|95.0|0.69|1.12|||Log Rank|||||1.12|0.69|0.2811
70946559|NCT03024996|141393632|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0735|TWO_SIDED|95.0|0.55|1.03|||Log Rank|||||1.03|0.55|0.0735
70946560|NCT03024996|141393633|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.1396|TWO_SIDED|95.0|0.67|1.06|||Log Rank|||||1.06|0.67|0.1396
71090617|NCT02966834|141687599|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-0.3|0.7|||||Duration|||0.7|-0.3|
70858216|NCT03485495|141202479|SUPERIORITY|||||||0.46||||||"The p-value associated with treatment\*visit interaction between Divaza and Placebo treatment groups. Model includes cuff test status, treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to NO data.||||0.46
70858217|NCT03485495|141202480|SUPERIORITY|||||||0.88||||||"The p-value associated with treatment\*visit interaction between Divaza and Placebo treatment groups. Model includes cuff test status, treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to ADP-PA data.||||0.88
70858218|NCT03485495|141202480|SUPERIORITY|||||||0.93||||||"The p-value associated with treatment\*visit interaction between Divaza and Placebo treatment groups. Model includes cuff test status, treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to ADR-PA data.||||0.93
71090618|NCT02966834|141687599|OTHER||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.4|0.6|||||Duration|||0.6|-0.4|
71090619|NCT02966834|141687599|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.8|0.3|||||Degree|||0.3|-0.8|
71090620|NCT02966834|141687599|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.5|0.5|||||Degree|||0.5|-0.5|
71090621|NCT02966834|141687599|OTHER||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.6|0.5|||||Degree|||0.5|-0.6|
71090622|NCT02966834|141687599|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.7|0.3|||||Degree|||0.3|-0.7|
71090623|NCT02966834|141687599|OTHER||Median Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.6|0.4|||||Degree|||0.4|-0.6|
71090624|NCT02966834|141687599|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Direction|||0.7|-0.7|
71090625|NCT02966834|141687599|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.7|0.6|||||Direction|||0.6|-0.7|
70946561|NCT03024996|141393634|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.4762|TWO_SIDED|95.0|0.55|1.33|||Log Rank|||||1.33|0.55|0.4762
71090626|NCT02966834|141687599|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.8|0.5|||||Direction|||0.5|-0.8|
71090627|NCT02966834|141687599|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-1.0|0.2|||||Direction|||0.2|-1.0|
71090628|NCT02966834|141687599|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.6|0.6|||||Direction|||0.6|-0.6|
71090629|NCT02966834|141687599|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-1.1|0.3|||||Disability|||0.3|-1.1|
71090630|NCT02966834|141687599|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.8|0.5|||||Disability|||0.5|-0.8|
71090631|NCT02966834|141687599|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.0|0.3|||||Disability|||0.3|-1.0|
71090632|NCT02966834|141687599|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.0|0.3|||||Disability|||0.3|-1.0|
71090633|NCT02966834|141687599|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.0|0.3|||||Disability|||0.3|-1.0|
71090634|NCT02966834|141687599|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-0.9|0.3|||||Distribution|||0.3|-0.9|
71090635|NCT02966834|141687599|OTHER||Median Difference (Net)|-0.3|||||TWO_SIDED|95.0|-0.9|0.2|||||Distribution|||0.2|-0.9|
71090636|NCT02966834|141687599|OTHER||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-1.0|0.0|||||Distribution|||0.0|-1.0|
71090637|NCT02966834|141687599|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-0.9|0.2|||||Distribution|||0.2|-0.9|
71090638|NCT02966834|141687599|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.7|0.3|||||Distribution|||0.3|-0.7|
71090639|NCT02966834|141687599|OTHER||Mean Difference (Net)|-1.0|||||TWO_SIDED|95.0|-3.3|1.3|||||5-D Itch Total Score|||1.3|-3.3|
71090640|NCT02966834|141687599|OTHER||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-2.2|2.1|||||5-D Itch Total Score|||2.1|-2.2|
71090641|NCT02966834|141687599|OTHER||Mean Difference (Net)|-1.4|||||TWO_SIDED|95.0|-3.5|0.7|||||5-D Itch Total Score|||0.7|-3.5|
71090642|NCT02966834|141687599|OTHER||Mean Difference (Net)|-0.9|||||TWO_SIDED|95.0|-3.0|1.2|||||5-D Itch Total Score|||1.2|-3.0|
71090643|NCT02966834|141687599|OTHER||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-2.7|1.6|||||5-D Itch Total Score|||1.6|-2.7|
71090644|NCT02966834|141687603|OTHER||Mean Difference (Net)|-0.71|||||TWO_SIDED|95.0|-1.69|0.28||||||||0.28|-1.69|
71090645|NCT02966834|141687603|OTHER||Mean Difference (Net)|-0.62|||||TWO_SIDED|95.0|-1.49|0.26||||||||0.26|-1.49|
70858219|NCT02915874|141202485|SUPERIORITY||Slope|-1.13|STANDARD_ERROR_OF_MEAN|0.47||0.02|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis|||||||0.02
70858220|NCT02915874|141202486|SUPERIORITY||Slope|-1.02|STANDARD_ERROR_OF_MEAN|0.78||0.19|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis|||||||0.19
70858221|NCT02915874|141202487|SUPERIORITY||Slope|2.07|STANDARD_ERROR_OF_MEAN|1.86||0.27|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis|||||||0.27
70946562|NCT03024996|141393635|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.5111|TWO_SIDED|95.0|0.74|1.16|||Log Rank|||||1.16|0.74|0.5111
71090646|NCT02966834|141687603|OTHER||Mean Difference (Net)|-0.9|||||TWO_SIDED|95.0|-1.76|-0.03||||||||-0.03|-1.76|
71090647|NCT02966834|141687603|OTHER||Mean Difference (Net)|-1.16|||||TWO_SIDED|95.0|-2.05|-0.28||||||||-0.28|-2.05|
71090648|NCT02966834|141687603|OTHER||Mean Difference (Net)|-0.95|||||TWO_SIDED|95.0|-1.85|-0.06||||||||-0.06|-1.85|
71090649|NCT02966834|141687604|OTHER||Least Square (LS) mean ratio|0.967|||||TWO_SIDED|95.0|0.635|1.471||||||||1.471|0.635|
71090650|NCT02966834|141687604|OTHER||LS mean ratio|1.17|||||TWO_SIDED|95.0|0.8|1.712||||||||1.712|0.8|
71090651|NCT02966834|141687604|OTHER||LS mean ratio|0.909|||||TWO_SIDED|95.0|0.627|1.316||||||||1.316|0.627|
71090652|NCT02966834|141687604|OTHER||LS mean ratio|0.69|||||TWO_SIDED|95.0|0.474|1.005||||||||1.005|0.474|
71090653|NCT02966834|141687604|OTHER||LS mean ratio|0.825|||||TWO_SIDED|95.0|0.564|1.207||||||||1.207|0.564|
71090654|NCT02966834|141687605|OTHER||LS mean ratio|1.363|||||TWO_SIDED|95.0|0.932|1.995||||||||1.995|0.932|
71090655|NCT02966834|141687605|OTHER||LS mean ratio|2.05|||||TWO_SIDED|95.0|1.456|2.887||||||||2.887|1.456|
71090656|NCT02966834|141687605|OTHER||LS mean ratio|2.457|||||TWO_SIDED|95.0|1.758|3.436||||||||3.436|1.758|
71090657|NCT02966834|141687605|OTHER||LS mean ratio|3.128|||||TWO_SIDED|95.0|2.206|4.435||||||||4.435|2.206|
71090658|NCT02966834|141687605|OTHER||LS mean ratio|2.701|||||TWO_SIDED|95.0|1.915|3.81||||||||3.81|1.915|
71090659|NCT02814526|141687608|SUPERIORITY||Mean Difference (Net)|0.078||||0.29|TWO_SIDED||||||Regression, Linear|||||||0.29
71090660|NCT02814526|141687609|SUPERIORITY||Mean Difference (Net)|0.031||||0.74|TWO_SIDED||||||Regression, Linear|||||||0.74
71090661|NCT02814526|141687610|SUPERIORITY||Mean Difference (Net)|-0.009447||||0.8284|TWO_SIDED||||||Regression, Linear|||||||0.8284
71090662|NCT02814526|141687611|SUPERIORITY||Mean Difference (Net)|-0.02024||||0.7086|TWO_SIDED||||||Regression, Linear|||||||0.7086
71090663|NCT02814526|141687612|SUPERIORITY||Mean Difference (Net)|0.29||||0.06|TWO_SIDED||||||Regression, Linear|||||||0.06
71090664|NCT02814526|141687613|SUPERIORITY||Mean Difference (Net)|-0.17||||0.33|TWO_SIDED||||||Regression, Linear|||||||0.33
71127687|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.49|0.42||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.42|-0.49|
71127688|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.47|0.44||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.44|-0.47|
71127689|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|0.22|1.18||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.18|0.22|
71127690|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.18|0.78||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.78|-0.18|
71127691|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|||||TWO_SIDED|95.0|-0.55|0.4||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.40|-0.55|
71127692|NCT01393639|141760278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.47|0.49||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.49|-0.47|
71127693|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-0.76|0.03||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.03|-0.76|
71127694|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|||||TWO_SIDED|95.0|-1.17|-0.39||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.39|-1.17|
70946563|NCT02106195|141393708|SUPERIORITY|Change from Baseline to Day 28|Mean Difference (Final Values)|-1.1|STANDARD_DEVIATION|3.04||0.324|TWO_SIDED|95.0|-3.7|1.4|||t-test, 2 sided|||||1.4|-3.7|0.324
71127695|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.93|||||TWO_SIDED|95.0|-1.32|-0.54||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.54|-1.32|
71127696|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.17|||||TWO_SIDED|95.0|-1.56|-0.78||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.78|-1.56|
71090665|NCT02814526|141687614|SUPERIORITY||Mean Difference (Net)|-0.1||||0.49|TWO_SIDED||||||Regression, Linear|||||||0.49
70946564|NCT00464945|141393734|SUPERIORITY_OR_OTHER||Difference|0.7||||||95.0|-3.9|5.6||||||For serotype 4 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||5.6|-3.9|
71090666|NCT02814526|141687615|SUPERIORITY||Mean Difference (Net)|-0.02||||0.61|TWO_SIDED||||||Regression, Linear|||||||0.61
71090667|NCT02814526|141687616|SUPERIORITY||Mean Difference (Net)|-0.01||||0.78|TWO_SIDED||||||Regression, Linear|||||||0.78
71090668|NCT02814526|141687617|SUPERIORITY||Mean Difference (Net)|-0.04||||0.31|TWO_SIDED||||||Regression, Linear|||||||0.31
71090669|NCT02814526|141687618|SUPERIORITY||Mean Difference (Net)|-0.0005||||0.817|TWO_SIDED||||||Regression, Linear|||||||0.817
71090670|NCT02814526|141687619|SUPERIORITY||Mean Difference (Net)|0.002||||0.64|TWO_SIDED||||||Regression, Linear|||||||0.64
71090671|NCT02814526|141687620|SUPERIORITY||Mean Difference (Net)|-0.01||||0.97|TWO_SIDED||||||Regression, Linear|||||||0.97
71090672|NCT02814526|141687621|SUPERIORITY||Mean Difference (Net)|-0.17||||0.94|TWO_SIDED||||||Regression, Linear|||||||0.94
71090673|NCT00251758|141687628|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
71090674|NCT00251758|141687628|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
71090675|NCT00251758|141687628|SUPERIORITY_OR_OTHER|||||||0.15505||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.15505
71090676|NCT00251758|141687630|SUPERIORITY_OR_OTHER|||||||1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.00001
70946565|NCT00464945|141393734|SUPERIORITY_OR_OTHER||Difference|3.3||||||95.0|-7.3|13.8||||||For serotype 6B the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||13.8|-7.3|
71127697|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-0.7|0.09||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.09|-0.70|
71127698|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.95|||||TWO_SIDED|95.0|-1.34|-0.55||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.55|-1.34|
71127699|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.39|||||TWO_SIDED|95.0|-0.84|0.07||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.07|-0.84|
71090677|NCT00251758|141687630|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
71090678|NCT00251758|141687630|SUPERIORITY_OR_OTHER|||||||0.3874||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.38740
71090679|NCT01387269|141687633|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon rank sum test|||Superiority analysis||||< 0.0001
71127700|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|||||TWO_SIDED|95.0|-1.23|-0.32||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.32|-1.23|
71127701|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.06|||||TWO_SIDED|95.0|-1.52|-0.61||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.61|-1.52|
71090680|NCT01387269|141687634|SUPERIORITY_OR_OTHER|||||||0.1475|||||||Wilcoxon rank sum test|||Superiority analysis||||0.1475
71090681|NCT01387269|141687635|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Mixed Models Analysis|||Superiority analysis||||0.0004
71090682|NCT01387269|141687636|SUPERIORITY_OR_OTHER|||||||0.0544|||||||Mixed Models Analysis|||Superiority analysis||||0.0544
71090683|NCT01387269|141687637|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||Superiority analysis||||< 0.0001
71090684|NCT01981616|141687639|NON_INFERIORITY_OR_EQUIVALENCE|"With 55 evaluable participants in each group, the study would have at least 80% power to exclude the non-inferiority margin of 15% with the lower bound of the 1-sided 95% confidence interval (CI) on the difference in proportions between vedolizumab- and placebo-treated participants, assuming a 90% seroconversion rate (anti-HBs of 10 IU/L) for hepatitis B vaccine.~If the lower bound of this interval was less than -15% (ie, more negative), then the null hypothesis was accepted."|Difference from placebo|-1.8|||||TWO_SIDED|95.0|-12.7|9.1||||||||9.1|-12.7|
71090685|NCT01981616|141687640|NON_INFERIORITY_OR_EQUIVALENCE|The sample size of 55 evaluable subjects in the vedolizumab 750 mg IV group and 55 evaluable participants in the placebo group provided at least 71% power to exclude the non-inferiority margin of 15% with the lower bound of the 1-sided 95% CI on the difference in proportions between vedolizumab- and placebo-treated participants, assuming an 85% seroconversion rate to the oral cholera vaccine (Dukoral).|Difference from placebo|-14.2|||||TWO_SIDED|95.0|-24.6|-3.9||||||||-3.9|-24.6|
71090686|NCT01141608|141687726|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Linear mixed effects model|||||||<0.05
71090687|NCT02753881|141687745|OTHER|||||||0.036||||||Two-sided p-values \<0.05 considered statistically significant.|Kruskal-Wallis|||To achieve high probability (80% power) to detect 50% change with 5% significance level, calculated total sample size was 30 participants for dose normalized doxorubicin.||||.036
70946566|NCT00464945|141393734|SUPERIORITY_OR_OTHER||Difference|2.3||||||95.0|-2.1|7.3||||||For serotype 9V the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||7.3|-2.1|
71090688|NCT02753881|141687745|OTHER|||||||0.002||||||Two-sided p-values \<0.05 considered statistically significant.|Kruskal-Wallis|||To achieve high probability (80% power) to detect 50% change with 5% significance level, calculated total sample size was 30 participants for dose normalized doxorubicinol.||||0.002
71090689|NCT02753881|141687747|OTHER|||||||0.023||||||Two-sided p-values \<0.05 considered statistically significant.|Kruskal-Wallis|||To achieve high probability (80% power) to detect 50% change with 5% significance level, calculated total sample size was 30 participants for time-concentration-curves for doxorubicin.||||0.023
71090690|NCT02753881|141687747|OTHER|||||||0.041||||||Two-sided p-values \<0.05 considered statistically significant.|Kruskal-Wallis|||To achieve high probability (80% power) to detect 50% change with 5% significance level, calculated total sample size was 30 participants for time-concentration-curves for doxorubicinol.||||0.041
71090691|NCT00506675|141687752|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED|95.0|||||ANCOVA|||||||0.30
71090692|NCT00506675|141687753|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||ANCOVA|||||||0.30
71090693|NCT00506675|141687754|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED|95.0|||||ANCOVA|||||||0.30
71090694|NCT02858908|141687760|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.6696||||0.0484|TWO_SIDED|95.0|-1.334|-0.0051|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the time taken (seconds) to complete 10-metre walk/run test at the preferred speed||-0.0051|-1.3340|0.0484
71127702|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-1.45|-0.54||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.54|-1.45|
71127703|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|||||TWO_SIDED|95.0|-0.71|0.21||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.21|-0.71|
71127704|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.02|||||TWO_SIDED|95.0|-1.48|-0.57||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.57|-1.48|
71127705|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.39|||||TWO_SIDED|95.0|-0.89|0.11||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.11|-0.89|
71127706|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.94|||||TWO_SIDED|95.0|-1.44|-0.45||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.45|-1.44|
71127707|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.21|||||TWO_SIDED|95.0|-1.71|-0.71||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.71|-1.71|
70858222|NCT02915874|141202488|SUPERIORITY||Slope|-0.49|STANDARD_ERROR_OF_MEAN|21.3||0.98|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis|||||||0.98
70858223|NCT02915874|141202489|SUPERIORITY||Slope|1.03|STANDARD_ERROR_OF_MEAN|2.58||0.69|TWO_SIDED|||||a priori: 0.05|Mixed Models Analysis|||||||0.69
70858224|NCT02915874|141202490|SUPERIORITY||Slope|-2.77|STANDARD_ERROR_OF_MEAN|4.93||0.58|TWO_SIDED||||||Mixed Models Analysis|||||||0.58
70858225|NCT02915874|141202491|SUPERIORITY||Slope|-1.02|STANDARD_ERROR_OF_MEAN|0.58||0.08|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis|||||||0.08
70858226|NCT00400153|141202560|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.05 liter|Mean Difference (Final Values)|-0.0035|STANDARD_ERROR_OF_MEAN|0.0095||0.7135||95.0|-0.0222|0.0152|||ANCOVA|||||0.0152|-0.0222|0.7135
70858227|NCT00400153|141202561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001||95.0|0.028|0.066|||ANCOVA|||||0.066|0.028|< 0.0001
70858228|NCT00400153|141202562|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.05 liters|Mean Difference (Final Values)|-0.017|STANDARD_ERROR_OF_MEAN|0.011||0.1389||95.0|-0.039|0.005|||ANCOVA|||||0.005|-0.039|0.1389
70858229|NCT00400153|141202563|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established for this comparison.|Mean Difference (Final Values)|-0.016|STANDARD_ERROR_OF_MEAN|0.01||0.124||95.0|-0.036|0.004|||ANCOVA|||||0.004|-0.036|0.124
70858230|NCT00400153|141202564|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established for this comparison.|Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.01||0.4888||95.0|-0.026|0.013|||ANCOVA|||||0.013|-0.026|0.4888
71127708|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.09|||||TWO_SIDED|95.0|-1.59|-0.59||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.59|-1.59|
71127709|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|||||TWO_SIDED|95.0|-0.95|0.05||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.05|-0.95|
70858231|NCT00400153|141202565|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established for this comparison.|Mean Difference (Final Values)|-0.014||||0.1433||95.0|-0.033|0.005|||ANCOVA|||||0.005|-0.033|0.1433
70858232|NCT00400153|141202566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001||95.0|0.04|0.083|||ANCOVA|||This analysis is purely exploratory.||0.083|0.04|< 0.0001
70858233|NCT00400153|141202567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001||95.0|0.024|0.065|||ANCOVA|||This analysis is purely exploratory.||0.065|0.024|< 0.0001
71127710|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.15|||||TWO_SIDED|95.0|-1.65|-0.66||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.66|-1.65|
71127711|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44|||||TWO_SIDED|95.0|-0.96|0.08||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.08|-0.96|
70858234|NCT00400153|141202568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001||95.0|0.027|0.067|||ANCOVA|||This analysis is purely exploratory.||0.067|0.027|< 0.0001
70858235|NCT00400153|141202569|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.026|STANDARD_ERROR_OF_MEAN|0.012||0.0258||95.0|0.003|0.049|||ANCOVA|||||0.049|0.003|0.0258
70858236|NCT00400153|141202570|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.011||0.3749||95.0|-0.032|0.012|||ANCOVA|||||0.012|-0.032|0.3749
70858237|NCT00400153|141202571|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.011|STANDARD_ERROR_OF_MEAN|0.011||0.3355||95.0|-0.033|0.011|||ANCOVA|||||0.011|-0.033|0.3355
70858238|NCT00400153|141202572|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.011||0.0743||95.0|-0.042|0.002|||ANCOVA|||||0.002|-0.042|0.0743
70858239|NCT00400153|141202573|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.011||0.5711||95.0|-0.015|0.028|||ANCOVA|||||0.028|-0.015|0.5711
70858240|NCT00400153|141202574|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.013|STANDARD_ERROR_OF_MEAN|0.011||0.2274||95.0|-0.033|0.008|||ANCOVA|||||0.008|-0.033|0.2274
70858241|NCT00400153|141202575|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.003|STANDARD_ERROR_OF_MEAN|0.011||0.8065||95.0|-0.018|0.024|||ANCOVA|||||0.024|-0.018|0.8065
70858242|NCT00400153|141202576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001||95.0|0.043|0.087|||ANCOVA|||This analysis is purely exploratory.||0.087|0.043|< 0.0001
70858243|NCT00400153|141202577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001||95.0|0.044|0.087|||ANCOVA|||This analysis is purely exploratory.||0.087|0.044|< 0.0001
70858244|NCT00400153|141202578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001||95.0|0.04|0.081|||ANCOVA|||This analysis is purely exploratory.||0.081|0.04|< 0.0001
70858245|NCT00400153|141202579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001||95.0|0.047|0.089|||ANCOVA|||This analysis is purely exploratory.||0.089|0.047|< 0.0001
70858246|NCT00400153|141202592|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.017|STANDARD_ERROR_OF_MEAN|0.021||0.417||95.0|-0.058|0.024|||ANCOVA|||||0.024|-0.058|0.417
70946567|NCT00464945|141393734|SUPERIORITY_OR_OTHER||Difference|-1.6||||||95.0|-8.2|4.7||||||For serotype 14 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||4.7|-8.2|
71127712|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.96|||||TWO_SIDED|95.0|-1.48|-0.44||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.44|-1.48|
71127713|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.43|||||TWO_SIDED|95.0|-1.94|-0.91||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.91|-1.94|
71127714|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.28|||||TWO_SIDED|95.0|-1.8|-0.76||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.76|-1.80|
71127715|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|||||TWO_SIDED|95.0|-1.06|-0.03||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.03|-1.06|
71127716|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.33|||||TWO_SIDED|95.0|-1.85|-0.81||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.81|-1.85|
71127717|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.59|||||TWO_SIDED|95.0|0.19|0.98||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.98|0.19|
71127718|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-0.22|0.56||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.56|-0.22|
71127719|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.38|0.41||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.41|-0.38|
71127720|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|||||TWO_SIDED|95.0|-0.62|0.16||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.16|-0.62|
71127721|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.64|||||TWO_SIDED|95.0|0.18|1.09||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.09|0.18|
71127722|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|||||TWO_SIDED|95.0|-0.21|0.7||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.70|-0.21|
71127723|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.5|0.42||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.42|-0.50|
71127724|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.43|0.48||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.48|-0.43|
70946568|NCT00464945|141393734|SUPERIORITY_OR_OTHER||Difference|3.0||||||95.0|-2.8|9.2||||||For serotype 18C the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||9.2|-2.8|
71127725|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.76|||||TWO_SIDED|95.0|0.26|1.26||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.26|0.26|
71127726|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21|||||TWO_SIDED|95.0|-0.29|0.7||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.70|-0.29|
71127727|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|95.0|-0.55|0.44||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.44|-0.55|
71127728|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.43|0.56||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.56|-0.43|
70946569|NCT00464945|141393734|SUPERIORITY_OR_OTHER||Difference|0.7||||||95.0|-3.5|5.1||||||For serotype 19F the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||5.1|-3.5|
70858247|NCT00400153|141202593|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.02||0.3505||95.0|-0.059|0.021|||ANCOVA|||||0.021|-0.059|0.3505
70858248|NCT00400153|141202594|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.02||0.3499||95.0|-0.058|0.021|||ANCOVA|||||0.021|-0.058|0.3499
70946570|NCT00464945|141393734|SUPERIORITY_OR_OTHER||Difference|1.1||||||95.0|-8.4|10.6||||||For serotype 23F the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||10.6|-8.4|
70946571|NCT00464945|141393734|SUPERIORITY_OR_OTHER||Difference|2.1||||||95.0|-4.8|9.2||||||For serotype 1 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||9.2|-4.8|
71090695|NCT02858908|141687760|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.6449||||0.0565|TWO_SIDED|95.0|-1.3094|0.0195|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the time taken (seconds) to complete 10-metre walk/run test at the preferred speed||0.0195|-1.3094|0.0565
71090696|NCT02858908|141687761|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|0.9102||||0.3732|TWO_SIDED|95.0|-1.1526|2.973|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in grip strength (kg)||2.9730|-1.1526|0.3732
71090697|NCT02858908|141687761|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-1.3897||||0.1782|TWO_SIDED|95.0|-3.4525|0.6731|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in grip strength (kg)||0.6731|-3.4525|0.1782
71090698|NCT02858908|141687762|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.0213||||0.8886|TWO_SIDED|95.0|-0.3368|0.2941|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in FVC (litres)||0.2941|-0.3368|0.8886
71090699|NCT02858908|141687762|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|0.0152||||0.9204|TWO_SIDED|95.0|-0.3003|0.3307|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in FVC (litres)||0.3307|-0.3003|0.9204
71090700|NCT02858908|141687763|OTHER|The exact Wilcoxon signed rank test was used to test for a change in the DXA scan total lean muscle mass (g) from baseline to end of treatment|Median Difference (Net)|-42.75||||1|TWO_SIDED|95.0|-1270.0|2178.5|||ANCOVA||Hodges-Lehmann estimates for the median and confidence intervals are presented|Changes from baseline to week 12 in the DXA scan total lean muscle mass (g)||2178.50|-1270.00|1.0000
71090701|NCT02858908|141687763|OTHER|The exact Wilcoxon signed rank test was used to test for a change in the DXA scan total lean muscle mass (g) from baseline to end of treatment|Median Difference (Net)|426.75||||0.3125|TWO_SIDED|95.0|-289.5|1198.5|||ANCOVA||Hodges-Lehmann estimates for the median and confidence intervals are presented|Changes from baseline to week 12 in the DXA scan total lean muscle mass (g)||1198.50|-289.50|0.3125
71090702|NCT02858908|141687765|OTHER|A mixed effect model repeated measure (MMRM) was fitted to the observed values at week12. The model included dose group and visit as fixed effects, and the treatment-by-visit interaction. F-tests from PROC MIXED were based on Kenward-Roger's adjusted degrees of freedom.|Mean Difference (Net)|3.1||||0.003|TWO_SIDED|95.0|2.6|3.7||The p-value is presented for the comparison of adjusted Least Square Means to a score of 4, representing 'No change'|Mixed Models Analysis|||Observed value at week 12 in Clinical Global Impression Global Improvement Scale (CGI-I)||3.7|2.6|0.0030
71127729|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.89|||||TWO_SIDED|95.0|0.37|1.41||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.41|0.37|
70858249|NCT00400153|141202595|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.02||0.8288||95.0|-0.044|0.035|||ANCOVA|||||0.035|-0.044|0.8288
70858250|NCT00400153|141202596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.069|0.154|||ANCOVA|||This analysis is purely exploratory.||0.154|0.069|< 0.0001
70946572|NCT00464945|141393734|SUPERIORITY_OR_OTHER||Difference|-1.7||||||95.0|-7.9|4.2||||||For serotype 3 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||4.2|-7.9|
70858251|NCT00400153|141202597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.049|0.132|||ANCOVA|||This analysis is purely exploratory.||0.132|0.049|< 0.0001
70946573|NCT00464945|141393734|SUPERIORITY_OR_OTHER||Difference|2.1||||||95.0|-5.6|9.9||||||For serotype 5 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||9.9|-5.6|
70946574|NCT00464945|141393734|SUPERIORITY_OR_OTHER||Difference|-1.1||||||95.0|-9.9|7.6||||||For serotype 6A the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||7.6|-9.9|
70858252|NCT00400153|141202598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.056|0.138|||ANCOVA|||This analysis is purely exploratory.||0.138|0.056|< 0.0001
70946575|NCT00464945|141393734|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-3.0|2.8||||||For serotype 7F the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||2.8|-3.0|
70946576|NCT00464945|141393734|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-3.6|3.5||||||For serotype 19A the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||3.5|-3.6|
70946577|NCT00464945|141393738|SUPERIORITY_OR_OTHER||Ratio|1.35||||||95.0|1.1|1.65||||||For serotype 4 the GMC ratio was calculated||1.65|1.10|
71127730|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.37|||||TWO_SIDED|95.0|-0.15|0.89||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.89|-0.15|
70946578|NCT00464945|141393738|SUPERIORITY_OR_OTHER||Ratio|0.96||||||95.0|0.7|1.31||||||For serotype 6B the GMC ratio was calculated||1.31|0.70|
70946579|NCT00464945|141393738|SUPERIORITY_OR_OTHER||Ratio|1.05||||||95.0|0.89|1.24||||||For serotype 9V the GMC ratio was calculated||1.24|0.89|
70946580|NCT00464945|141393738|SUPERIORITY_OR_OTHER||Ratio|0.93||||||95.0|0.71|1.22||||||For serotype 14 the GMC ratio was calculated||1.22|0.71|
70946581|NCT00464945|141393738|SUPERIORITY_OR_OTHER||Ratio|1.06||||||95.0|0.86|1.3||||||For serotype 18C the GMC ratio was calculated||1.30|0.86|
70946582|NCT00464945|141393738|SUPERIORITY_OR_OTHER||Ratio|0.98||||||95.0|0.81|1.17||||||For serotype 19F the GMC ratio was calculated||1.17|0.81|
70946583|NCT00464945|141393738|SUPERIORITY_OR_OTHER||Ratio|0.9||||||95.0|0.7|1.15||||||For serotype 23F the GMC ratio was calculated||1.15|0.70|
70946584|NCT00464945|141393738|SUPERIORITY_OR_OTHER||Ratio|1.1||||||95.0|0.88|1.37||||||For serotype 1 the GMC ratio was calculated||1.37|0.88|
70946585|NCT00464945|141393738|SUPERIORITY_OR_OTHER||Ratio|1.0||||||95.0|0.83|1.2||||||For serotype 3 the GMC ratio was calculated||1.20|0.83|
70946586|NCT00464945|141393738|SUPERIORITY_OR_OTHER||Ratio|0.95||||||95.0|0.79|1.16||||||For serotype 5 the GMC ratio was calculated||1.16|0.79|
70946587|NCT00464945|141393738|SUPERIORITY_OR_OTHER||Ratio|0.83||||||95.0|0.66|1.05||||||For serotype 6A the GMC ratio was calculated||1.05|0.66|
70946588|NCT00464945|141393738|SUPERIORITY_OR_OTHER||Ratio|0.93||||||95.0|0.79|1.11||||||For serotype 7F the GMC ratio was calculated||1.11|0.79|
70946589|NCT00464945|141393738|SUPERIORITY_OR_OTHER||Ratio|0.95||||||95.0|0.79|1.13||||||For serotype 19A the GMC ratio was calculated||1.13|0.79|
70946590|NCT03831854|141393739|SUPERIORITY||Median Difference (Final Values)|0.0||||0.08|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.08
71127731|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|||||TWO_SIDED|95.0|-0.61|0.42||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.42|-0.61|
71127732|NCT01393639|141760280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|||||TWO_SIDED|95.0|-0.46|0.57||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.57|-0.46|
71127733|NCT01393639|141760282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.38|||||TWO_SIDED|95.0|-4.94|2.17||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.17|-4.94|
71127734|NCT01393639|141760282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|||||TWO_SIDED|95.0|-3.98|3.08||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.08|-3.98|
71127735|NCT01393639|141760282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|||||TWO_SIDED|95.0|-3.34|3.82||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.82|-3.34|
71127736|NCT01393639|141760282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.76|||||TWO_SIDED|95.0|-2.75|4.28||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.28|-2.75|
71127737|NCT01393639|141760282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.31|||||TWO_SIDED|95.0|-4.88|2.27||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.27|-4.88|
71127738|NCT01393639|141760282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.25|||||TWO_SIDED|95.0|-1.32|5.82||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.82|-1.32|
71127739|NCT01393639|141760282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.01|||||TWO_SIDED|95.0|-5.89|1.87||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.87|-5.89|
71127740|NCT01393639|141760282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.49|||||TWO_SIDED|95.0|-2.41|5.4||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.40|-2.41|
71127741|NCT01393639|141760282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.45|||||TWO_SIDED|95.0|-2.44|5.34||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.34|-2.44|
70946591|NCT03831854|141393740|SUPERIORITY|||||||0.11|||||||Fisher Exact|The relative risk could not be assessed due to zero incidence in the treatment group||||||0.11
71127742|NCT01393639|141760282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.89|||||TWO_SIDED|95.0|-1.98|5.76||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.76|-1.98|
71127743|NCT01393639|141760282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.73|||||TWO_SIDED|95.0|-3.16|4.61||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.61|-3.16|
71127744|NCT01393639|141760282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.18|||||TWO_SIDED|95.0|0.29|8.06||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.06|0.29|
71127745|NCT01393639|141760282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.64|||||TWO_SIDED|95.0|-7.21|-0.06||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.06|-7.21|
71127746|NCT01393639|141760282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-6.25|0.85||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.85|-6.25|
70946592|NCT03831854|141393741|SUPERIORITY||Median Difference (Final Values)|-2.3||||0.63|TWO_SIDED|98.5|-9.5|5.0|||Wilcoxon (Mann-Whitney)|||||5.0|-9.5|0.63
71127747|NCT01393639|141760282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.01|||||TWO_SIDED|95.0|-5.63|1.6||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.60|-5.63|
70858253|NCT00400153|141202599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.054|0.135|||ANCOVA|||This analysis is purely exploratory.||0.135|0.054|< 0.0001
70858254|NCT00400153|141202600|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.043|STANDARD_ERROR_OF_MEAN|0.024||0.0688||95.0|-0.003|0.09|||ANCOVA|||||0.09|-0.003|0.0688
70946593|NCT03831854|141393742|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.58|TWO_SIDED|98.3|-1.7|2.6|||t-test, 2 sided|||||2.6|-1.7|0.58
71127748|NCT01393639|141760282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.49|||||TWO_SIDED|95.0|-5.02|2.05||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.05|-5.02|
71127749|NCT01393639|141760282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.19|||||TWO_SIDED|95.0|-10.07|-2.31||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.31|-10.07|
71127750|NCT01393639|141760282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.69|||||TWO_SIDED|95.0|-6.6|1.23||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.23|-6.60|
71127751|NCT01393639|141760282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.73|||||TWO_SIDED|95.0|-6.64|1.18||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.18|-6.64|
71127752|NCT01393639|141760282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.29|||||TWO_SIDED|95.0|-6.16|1.58||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.58|-6.16|
71127753|NCT01393639|141760284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.73|||||TWO_SIDED|95.0|-0.83|4.3||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.30|-0.83|
71127754|NCT01393639|141760284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.9|||||TWO_SIDED|95.0|0.35|5.45||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.45|0.35|
71127755|NCT01393639|141760284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.12|||||TWO_SIDED|95.0|3.54|8.7||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.70|3.54|
71127756|NCT01393639|141760284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.73|||||TWO_SIDED|95.0|2.19|7.26||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.26|2.19|
71127757|NCT01393639|141760284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.18|||||TWO_SIDED|95.0|-0.39|4.76||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.76|-0.39|
71127758|NCT01393639|141760284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.41|||||TWO_SIDED|95.0|2.83|7.99||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.99|2.83|
70858255|NCT00400153|141202601|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.023||0.3895||95.0|-0.064|0.025|||ANCOVA|||||0.025|-0.064|0.3895
70858256|NCT00400153|141202602|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.022||0.959||95.0|-0.045|0.042|||ANCOVA|||||0.042|-0.045|0.959
70858257|NCT00400153|141202603|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.023||0.7652||95.0|-0.053|0.039|||ANCOVA|||||0.039|-0.053|0.7652
70858258|NCT00400153|141202604|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.011|STANDARD_ERROR_OF_MEAN|0.023||0.6244||95.0|-0.057|0.034|||ANCOVA|||||0.034|-0.057|0.6244
70858259|NCT00400153|141202605|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.023||0.873||95.0|-0.041|0.049|||ANCOVA|||||0.049|-0.041|0.873
70858260|NCT00400153|141202606|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.023||0.5294||95.0|-0.06|0.031|||ANCOVA|||||0.031|-0.06|0.5294
70858261|NCT00400153|141202607|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.013|STANDARD_ERROR_OF_MEAN|0.023||0.563||95.0|-0.032|0.058|||ANCOVA|||||0.058|-0.032|0.563
70858262|NCT00400153|141202608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.075|0.167|||ANCOVA|||This analysis is purely exploratory.||0.167|0.075|< 0.0001
70858263|NCT00400153|141202609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.084|0.174|||ANCOVA|||This analysis is purely exploratory.||0.174|0.084|< 0.0001
70858264|NCT00400153|141202610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.072|0.163|||ANCOVA|||This analysis is purely exploratory.||0.163|0.072|< 0.0001
70858265|NCT00400153|141202611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.081|0.171|||ANCOVA|||This analysis is purely exploratory.||0.171|0.081|< 0.0001
70858266|NCT00400153|141202616|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.00045|STANDARD_ERROR_OF_MEAN|0.06396||0.9943||95.0|-0.1259|0.125|||ANCOVA|||||0.125|-0.1259|0.9943
70858267|NCT00400153|141202616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01995|STANDARD_ERROR_OF_MEAN|0.06441||0.7569|TWO_SIDED|95.0|-0.1463|0.1064|||ANCOVA|||This analysis is purely exploratory.||0.1064|-0.1463|0.7569
71127759|NCT01393639|141760284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.79|||||TWO_SIDED|95.0|-1.08|4.65||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.65|-1.08|
70858268|NCT00400153|141202617|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.1091|STANDARD_ERROR_OF_MEAN|0.1206||0.3659||95.0|-0.1276|0.3458|||ANCOVA|||||0.3458|-0.1276|0.3659
70858269|NCT00400153|141202617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1554|STANDARD_ERROR_OF_MEAN|0.122||0.203|TWO_SIDED|95.0|-0.3947|0.08395|||ANCOVA|||This analysis is purely exploratory.||0.08395|-0.3947|0.203
70858270|NCT00400153|141202618|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.007734|STANDARD_ERROR_OF_MEAN|0.03199||0.809||95.0|-0.05503|0.0705|||ANCOVA|||||0.0705|-0.05503|0.809
70858271|NCT00400153|141202618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06501|STANDARD_ERROR_OF_MEAN|0.03225||0.044|TWO_SIDED|95.0|0.001746|0.1283|||ANCOVA|||This analysis is purely exploratory.||0.1283|0.001746|0.044
70858272|NCT00400153|141202619|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.0129|STANDARD_ERROR_OF_MEAN|0.03002||0.6674||95.0|-0.04598|0.07179|||ANCOVA|||||0.07179|-0.04598|0.6674
70858273|NCT00400153|141202619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01573|STANDARD_ERROR_OF_MEAN|0.03033||0.604|TWO_SIDED|95.0|-0.04376|0.07523|||ANCOVA|||This analysis is purely exploratory.||0.07523|-0.04376|0.604
70858274|NCT00400153|141202620|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|1.6526|STANDARD_ERROR_OF_MEAN|2.0653||0.4238||95.0|-2.3995|5.7047|||ANCOVA|||||5.7047|-2.3995|0.4238
70858275|NCT00400153|141202620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4376|STANDARD_ERROR_OF_MEAN|2.0874||0.2431|TWO_SIDED|95.0|-1.6578|6.533|||ANCOVA|||This analysis is purely exploratory.||6.533|-1.6578|0.2431
70858276|NCT00400153|141202621|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.056||0.173||95.0|-0.034|0.187|||ANCOVA|||||0.187|-0.034|0.173
70858277|NCT00400153|141202621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.056||0.336|TWO_SIDED|95.0|-0.165|0.056|||ANCOVA|||This analysis is purely exploratory.||0.056|-0.165|0.336
70858278|NCT00400153|141202622|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.062||0.924||95.0|-0.115|0.127|||ANCOVA|||||0.127|-0.115|0.924
70858279|NCT00400153|141202622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.069|STANDARD_ERROR_OF_MEAN|0.062||0.266|TWO_SIDED|95.0|-0.19|0.053|||ANCOVA|||This analysis is purely exploratory.||0.053|-0.19|0.266
70858280|NCT00400153|141202623|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.065||0.139||95.0|-0.031|0.225|||ANCOVA|||||0.225|-0.031|0.139
70858281|NCT00400153|141202623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.018|STANDARD_ERROR_OF_MEAN|0.066||0.788|TWO_SIDED|95.0|-0.111|0.146|||ANCOVA|||This analysis is purely exploratory.||0.146|-0.111|0.788
70858282|NCT00400153|141202628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.398|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
70946594|NCT03831854|141393743|SUPERIORITY||Risk Ratio (RR)|1.0||||1|TWO_SIDED|98.3|0.3|3.8|||Chi-squared|||||3.8|0.3|1.0
70946595|NCT03305809|141393748|SUPERIORITY||Posterior Mean Difference|-0.89|||||TWO_SIDED|95.0|-2.776|0.969|||||Analyses were conducted using a bayesian mixed-model repeated measures (MMRM), and posterior mean change difference is reported.|||0.969|-2.776|
71090703|NCT02858908|141687765|OTHER|A mixed effect model repeated measure (MMRM) was fitted to the observed values at week12. The model included dose group and visit as fixed effects, and the treatment-by-visit interaction. F-tests from PROC MIXED were based on Kenward-Roger's adjusted degrees of freedom.|Mean Difference (Net)|3.0||||0.0009|TWO_SIDED|95.0|2.4|3.6||The p-value is presented for the comparison of adjusted Least Square Means to a score of 4, representing 'No change'|Mixed Models Analysis|||Observed value at week 12 in Clinical Global Impression Global Improvement Scale (CGI-I)||3.6|2.4|0.0009
71090704|NCT02858908|141687766|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.132||||0.1857|TWO_SIDED|95.0|-0.33|0.066|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the weekly total number of 3 minute bouts of activity per hour wear time||0.066|-0.330|0.1857
70946596|NCT03305809|141393748|SUPERIORITY||Posterior Mean Difference|-0.08|||||TWO_SIDED|95.0|-1.996|1.879|||||Analyses were conducted using a bayesian MMRM, and posterior mean change difference is reported.|||1.879|-1.996|
70946597|NCT03305809|141393748|SUPERIORITY||Posterior Mean Difference|-0.78|||||TWO_SIDED|95.0|-2.873|1.277|||||Analyses were conducted using a bayesian MMRM, and posterior mean change difference is reported.|||1.277|-2.873|
70946598|NCT03305809|141393749|SUPERIORITY||Mean Difference (Net)|-0.2||||0.273|TWO_SIDED|95.0|-0.54|0.15|||Mixed Models Analysis|||||0.15|-0.54|0.273
70946599|NCT03305809|141393749|SUPERIORITY||Mean Difference (Net)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.02|-0.3|||Mixed Models Analysis|||||-0.30|-1.02|<0.001
70946600|NCT03305809|141393749|SUPERIORITY||Mean Difference (Net)|-0.9|||<|0.001|TWO_SIDED|95.0|-1.29|-0.53|||Mixed Models Analysis|||||-0.53|-1.29|< 0.001
70946601|NCT03305809|141393750|SUPERIORITY||Mean Difference (Net)|-70.71|STANDARD_ERROR_OF_MEAN|68.495||0.303|TWO_SIDED|95.0|-205.53|64.11|||Mixed Models Analysis|||||64.11|-205.53|0.303
71127760|NCT01393639|141760284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.4|||||TWO_SIDED|95.0|1.52|7.28||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.28|1.52|
71127761|NCT01393639|141760284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.2|||||TWO_SIDED|95.0|3.33|9.07||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.07|3.33|
71127762|NCT01393639|141760284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.7|||||TWO_SIDED|95.0|0.85|6.55||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||6.55|0.85|
71127763|NCT01393639|141760284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.61|||||TWO_SIDED|95.0|0.74|6.47||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||6.47|0.74|
71127764|NCT01393639|141760284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.17|||||TWO_SIDED|95.0|3.29|9.04||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.04|3.29|
71127765|NCT01393639|141760284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.68|||||TWO_SIDED|95.0|-6.27|-1.09||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.09|-6.27|
71127766|NCT01393639|141760284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.51|||||TWO_SIDED|95.0|-5.07|0.05||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.05|-5.07|
71127767|NCT01393639|141760284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.71|||||TWO_SIDED|95.0|-1.88|3.3||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.30|-1.88|
71127768|NCT01393639|141760284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68|||||TWO_SIDED|95.0|-3.23|1.87||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.87|-3.23|
71127769|NCT01393639|141760284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.38|||||TWO_SIDED|95.0|-7.26|-1.5||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.50|-7.26|
71127770|NCT01393639|141760284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.76|||||TWO_SIDED|95.0|-4.65|1.12||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.12|-4.65|
71127771|NCT01393639|141760284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-2.84|2.91||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.91|-2.84|
71127772|NCT01393639|141760284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.47|||||TWO_SIDED|95.0|-5.33|0.39||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.39|-5.33|
71127773|NCT00793325|141760301|SUPERIORITY_OR_OTHER||||||=|0.575|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Age. The null hypothesis is that there is no difference between \<15 years and \>=15 years in the frequency of treatment related adverse events."||||=0.575
71127774|NCT00793325|141760302|SUPERIORITY_OR_OTHER||||||=|0.206|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Gender. The null hypothesis is that there is no difference between Male and Female in the frequency of treatment related adverse events."||||=0.206
71127775|NCT00793325|141760303|SUPERIORITY_OR_OTHER||||||=|0.033|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Severity. The null hypothesis is that there is no association between mild, moderate and severe in the frequency of treatment related adverse events."||||=0.033
70946602|NCT03305809|141393750|SUPERIORITY||Median Difference (Net)|-107.02|STANDARD_ERROR_OF_MEAN|69.647||0.125|TWO_SIDED|95.0|-244.09|30.06|||Mixed Models Analysis|||||30.06|-244.09|0.125
70946603|NCT03305809|141393750|SUPERIORITY||Mean Difference (Net)|-123.72|STANDARD_ERROR_OF_MEAN|72.892||0.091|TWO_SIDED|95.0|-267.18|19.74|||Mixed Models Analysis|||||19.74|-267.18|0.091
70946604|NCT03305809|141393751|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.985||0.686|TWO_SIDED|95.0|-2.34|1.54|||Mixed Models Analysis|||||1.54|-2.34|0.686
70858283|NCT00400153|141202629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.482|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||<0.0001
70946605|NCT03305809|141393751|SUPERIORITY||Mean Difference (Net)|-0.71|STANDARD_ERROR_OF_MEAN|1.011||0.485|TWO_SIDED|95.0|-2.7|1.28|||Mixed Models Analysis|||||1.28|-2.70|0.485
70946606|NCT03305809|141393751|SUPERIORITY||Mean Difference (Net)|-0.89|STANDARD_ERROR_OF_MEAN|1.064||0.406|TWO_SIDED|95.0|-2.98|1.21|||Mixed Models Analysis|||||1.21|-2.98|0.406
71127776|NCT00793325|141760303|SUPERIORITY_OR_OTHER||||||=|0.207|TWO_SIDED||||||Cochran-Armitage Exact|||"The risk factor tested was Severity. The null hypothesis is that there is no linear trend in the frequency of treatment related adverse events across increasing levels of severity."||||=0.207
71127777|NCT00793325|141760304|SUPERIORITY_OR_OTHER||||||=|0.013|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Past history of any disease. The null hypothesis is that there is no difference between With past history of any disease and Without past history any disease in the frequency of treatment related adverse events."||||=0.013
71127778|NCT00793325|141760305|SUPERIORITY_OR_OTHER||||||=|0.009|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Complication(s). The null hypothesis is that there is no difference between With complication(s) and Without complication(s)in the frequency of treatment related adverse events."||||=0.009
71127779|NCT00793325|141760306|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Hepatic Function Disorder. The null hypothesis is that there is no difference between with Hepatic Function Disorder and without Hepatic Function Disorder in the frequency of treatment related adverse events."||||<0.001
71127780|NCT00793325|141760307|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Renal Impairment. The null hypothesis is that there is no difference between With Renal Impairment and Without Renal Impairment in the frequency of treatment related adverse events."||||<0.001
71127781|NCT00793325|141760308|SUPERIORITY_OR_OTHER||||||=|0.003|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Concomitant Drug(s). The null hypothesis is that there is no difference between With Concomitant Drug(s) and Without Concomitant Drug(s) in the frequency of treatment related adverse events."||||=0.003
71127782|NCT00793325|141760309|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the growth rate SD score for calendar age between SGA at one year and SGA at baseline.||||<0.001
70946607|NCT03305809|141393752|SUPERIORITY||Mean Difference (Net)|0.44|STANDARD_ERROR_OF_MEAN|0.603||0.464|TWO_SIDED|95.0|-0.74|1.63|||Mixed Models Analysis|||||1.63|-0.74|0.464
71127783|NCT00793325|141760309|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the null hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the growth rate SD score for calendar age between SGA at two years and SGA at baseline.||||<0.001
71127784|NCT00793325|141760309|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the null hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the growth rate SD score for calendar age between SGA at three years and SGA at baseline.||||<0.001
71127785|NCT00793325|141760310|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the null hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the height SD score for calendar age between SGA at one year and SGA at baseline.||||<0.001
71127786|NCT00793325|141760310|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the null hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the height SD score for calendar age between SGA at two years and SGA at baseline.||||<0.001
71127787|NCT00793325|141760310|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the height SD score for calendar age between SGA at three years and SGA at baseline.||||<0.001
70946608|NCT03305809|141393752|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.623||0.72|TWO_SIDED|95.0|-1.0|1.45|||Mixed Models Analysis|||||1.45|-1.00|0.720
70858284|NCT00400153|141202630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.612|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||<0.0001
70946609|NCT03305809|141393752|SUPERIORITY||Mean Difference (Net)|0.95|STANDARD_ERROR_OF_MEAN|0.655||0.149|TWO_SIDED|95.0|-0.34|2.24|||Mixed Models Analysis|||||2.24|-0.34|0.149
70858285|NCT00400153|141202631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.508|STANDARD_ERROR_OF_MEAN|0.058|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||<0.0001
70858286|NCT00400153|141202632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.421|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
70858287|NCT00400153|141202633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
70858288|NCT00400153|141202634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
70858289|NCT00400153|141202635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.378|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
70946610|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|-0.62|STANDARD_ERROR_OF_MEAN|1.213||0.607|TWO_SIDED|95.0|-3.01|1.76|||Mixed Models Analysis|||Total Score||1.76|-3.01|0.607
70858290|NCT00400153|141202636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.402|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
70858291|NCT00400153|141202637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.464|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
70946611|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|1.265||0.18|TWO_SIDED|95.0|-4.19|0.79|||Mixed Models Analysis|||Total Score||0.79|-4.19|0.180
70858292|NCT01423604|141202646|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.733||||0.0494|TWO_SIDED|95.0|0.506|1.061||One-sided p-value.|Log Rank|||||1.061|0.506|0.0494
70946612|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|-0.75|STANDARD_ERROR_OF_MEAN|1.325||0.572|TWO_SIDED|95.0|-3.36|1.86|||Mixed Models Analysis|||Total Score||1.86|-3.36|0.572
70946613|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.173||0.32|TWO_SIDED|95.0|-0.51|0.17|||Mixed Models Analysis|||Delusions||0.17|-0.51|0.320
70858293|NCT01423604|141202646|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.502||||0.0081|TWO_SIDED|95.0|0.281|0.888||One-sided p-value.|Log Rank|||Cox Regression Analysis of Overall Survival: C-reactive protein (CRP) \> 13 μg/ml; Statistical analysis plan (SAP) specified subgroup analysis||0.888|0.281|0.0081
70858294|NCT01423604|141202647|SUPERIORITY_OR_OTHER||Efron approximation of hazard ratio|0.75||||0.134|TWO_SIDED|95.0|0.513|1.094||Two-sided p-value.|Cox proportional hazards model|||||1.094|0.513|0.1340
70858295|NCT01423604|141202649|SUPERIORITY_OR_OTHER|||||||0.0236|||||||Pearson's chi-square test|||||||0.0236
70946614|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|-0.38|STANDARD_ERROR_OF_MEAN|0.18||0.037|TWO_SIDED|95.0|-0.73|-0.02|||Mixed Models Analysis|||Delusions||-0.02|-0.73|0.037
70946615|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.19||0.558|TWO_SIDED|95.0|-0.49|0.26|||Mixed Models Analysis|||Delusions||0.26|-0.49|0.558
70946616|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.182||0.924|TWO_SIDED|95.0|-0.38|0.34|||Mixed Models Analysis|||Hallucinations||0.34|-0.38|0.924
70858296|NCT00424255|141202651|SUPERIORITY_OR_OTHER|||||||0.2251||95.0||||The one-sided p-value is unstratified as there are too few events per stratum to perform a stratified test.|Non-stratified log-rank test|||||||0.2251
70858297|NCT00424255|141202651|SUPERIORITY_OR_OTHER|||||||0.4502||95.0||||The two-sided p-value is unstratified as there are too few events per stratum to perform a stratified test.|Non-stratified log-rank test|||||||0.4502
70858298|NCT00424255|141202651|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.85|1.43|||||Hazard Ratios were estimated using a Pike estimator.|||1.43|0.85|
70858299|NCT02186301|141202672|OTHER||Kaplan-Meier Median|274.0|||||TWO_SIDED|95.0|109.0||Upper Confidence Limit is not available because it cannot be calculated||||||||109|
70858300|NCT02186301|141202672|OTHER||Kaplan-Meier Median|207.0|||||TWO_SIDED|95.0|112.0|260.0||||||||260.0|112.0|
70946617|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|-0.36|STANDARD_ERROR_OF_MEAN|0.189||0.061|TWO_SIDED|95.0|-0.73|0.02|||Mixed Models Analysis|||Hallucinations||0.02|-0.73|0.061
70946618|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.199||0.148|TWO_SIDED|95.0|-0.68|0.1|||Mixed Models Analysis|||Hallucinations||0.10|-0.68|0.148
70858301|NCT02186301|141202672|OTHER||Kaplan Meier Median|390.0|||||TWO_SIDED|95.0|282.0|499.0||||||||499.0|282.0|
70858302|NCT02186301|141202673|OTHER||Percentage|25.0|||||TWO_SIDED|95.0|8.7|49.1||||||||49.1|8.7|
70858303|NCT02186301|141202673|OTHER||Percentage|40.0|||||TWO_SIDED|95.0|22.7|59.4||||||||59.4|22.7|
70858304|NCT02186301|141202673|OTHER||Percentage|78.0|||||TWO_SIDED|95.0|64.0|88.5||||||||88.5|64.0|
70858305|NCT02186301|141202674|OTHER||Kaplan Meier Median|225.0|||||TWO_SIDED|95.0|113.0||Upper Confidence Limit is not available because it cannot be calculated.||||||||113|
70858306|NCT02186301|141202674|OTHER||Kaplan Meier Median|195.5|||||TWO_SIDED|95.0|143.0|617.0||||||||617.0|143.0|
70858307|NCT02186301|141202674|OTHER||Kaplan Meier Median|335.0|||||TWO_SIDED|95.0|282.0|480.0||||||||480.0|282.0|
70858308|NCT03560739|141202676|EQUIVALENCE|For reference-scaled average bioequivalence testing, both criteria have to be met: 1) geo-mean ratio needs to fall in \[0.8, 1.25\]; 2) 95% upper bound of the linearized criterion needs to be \<= 0. This part is regarding criterion 1.|Geo-mean ratio|1.03|||||TWO_SIDED|90.0|0.8|1.25|||||The confidence interval reported in the Point Estimate section below is the one from the criterion, not the estimated confidence interval.|Criteria 1 for bioequivalence testing of AUCtau||1.25|.8|
70858309|NCT03560739|141202676|EQUIVALENCE|For reference-scaled average bioequivalence testing, both criteria have to be met: 1) geo-mean ratio needs to fall in \[0.8, 1.25\]; 2) 95% upper bound of the linearized criterion needs to be \<= 0. This part is regarding criterion 2.|95% upper bound of the linearized criter|-0.3131|||||ONE_SIDED|95.0||0.0|||||The upper limit reported in the Point Estimate section below is the limit on the 95% upper bound from the criterion, not the estimated upper limit of the 95% upper bound of the linearized criterion|Criteria 2 for bioequivalence testing of AUCtau||0||
70946619|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.18||0.552|TWO_SIDED|95.0|-0.46|0.25|||Mixed Models Analysis|||Agitation/Aggression||0.25|-0.46|0.552
70946620|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.188||0.735|TWO_SIDED|95.0|-0.43|0.31|||Mixed Models Analysis|||Agitation/Aggression||0.31|-0.43|0.735
70858310|NCT03560739|141202677|EQUIVALENCE|For reference-scaled average bioequivalence testing, both criteria have to be met: 1) geo-mean ratio needs to fall in \[0.8, 1.25\]; 2) 95% upper bound of the linearized criterion needs to be \<= 0. This part is regarding criterion 1.|geo-mean ratio|1.0|||||TWO_SIDED|90.0|0.8|1.25|||||The confidence interval reported in the Point Estimate section below is the one from the criterion, not the estimated confidence interval.|Criteria 1 for bioequivalence testing of Cmax||1.25|.8|
70858311|NCT03560739|141202677|EQUIVALENCE|For reference-scaled average bioequivalence testing, both criteria have to be met: 1) geo-mean ratio needs to fall in \[0.8, 1.25\]; 2) 95% upper bound of the linearized criterion needs to be \<= 0. This part is regarding criterion 2.|95% upper bound of the linearized criter|-0.2446|||||ONE_SIDED|95.0||0.0|||||The upper limit reported in the Point Estimate section below is the limit on the 95% upper bound from the criterion, not the estimated upper limit of the 95% upper bound of the linearized criterion.|Criteria 2 for bioequivalence testing of Cmax||0||
70858312|NCT03123185|141202686|OTHER|No hypothesis was tested and no acceptance range was specified.|Geometric mean (gMean) ratio (%)|158.61|STANDARD_ERROR_OF_MEAN|22.4|||TWO_SIDED|90.0|133.679|188.195|||||gMean ratio = 10 mg BI 705564 fed/10 mg BI 705564 fast. Standard Error of the mean is actually the intra-individual geometric coefficient variation.|"The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'. The effect subjects within sequences will be considered as random, the other effects as fixed."||188.195|133.679|
70858313|NCT03123185|141202687|OTHER|No hypothesis was tested and no acceptance range was specified.|gMean ratio (%)|194.18|STANDARD_ERROR_OF_MEAN|26.4|||TWO_SIDED|90.0|158.912|237.267|||||gMean ratio = 10 mg BI 705564 fed/10 mg BI 705564 fast. Standard Error of the mean is actually the intra-individual geometric coefficient variation.|"The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'. The effect subjects within sequences will be considered as random, the other effects as fixed."||237.267|158.912|
70858314|NCT03123185|141202688|OTHER||Slope|0.4879|STANDARD_ERROR_OF_MEAN|0.0546|||TWO_SIDED|95.0|0.3767|0.599|||||Based on the estimate for slope parameter, a 2-sided 95% Confidence Interval (CI) for the slope was computed. Standard error of the mean is actually standard error of slope. Perfect dose proportionality would correspond to a slope of 1.|The basic model for the investigation of dose proportionality for fasted condition was a power model that describes the functional relationship between the dose and PK endpoints.||0.5990|0.3767|
70858315|NCT03123185|141202688|OTHER||Slope|0.7553|STANDARD_ERROR_OF_MEAN|0.0876|||TWO_SIDED|95.0|0.5736|0.937|||||Based on the estimate for slope parameter, a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope. Perfect dose proportionality would correspond to a slope of 1.|The basic model for the investigation of dose proportionality for fed condition was a power model that describes the functional relationship between the dose and PK endpoints.||0.9370|0.5736|
70858316|NCT03123185|141202689|OTHER||Slope|0.4651|STANDARD_ERROR_OF_MEAN|0.1274|||TWO_SIDED|95.0|0.1935|0.7368|||||Based on the estimate for slope parameter, a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope. Perfect dose proportionality would correspond to a slope of 1.|The basic model for the investigation of dose proportionality for fasted condition was a power model that describes the functional relationship between the dose and PK endpoints.||0.7368|0.1935|
70872044|NCT01652703|141229481|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-45.3|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-51.02|-39.58||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-39.58|-51.02|<0.001
70946621|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.197||0.224|TWO_SIDED|95.0|-0.63|0.15|||Mixed Models Analysis|||Agitation/Aggression||0.15|-0.63|0.224
70858317|NCT03123185|141202689|OTHER||Slope|0.6651|STANDARD_ERROR_OF_MEAN|0.1385|||TWO_SIDED|95.0|0.3679|0.9622|||Power model||Based on the estimate for slope parameter, a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope. Perfect dose proportionality would correspond to a slope of 1.|The basic model for the investigation of dose proportionality for fed condition was a power model that describes the functional relationship between the dose and PK endpoints.||0.9622|0.3679|
70858318|NCT01083173|141202700|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||CD4 cell counts at 24 weeks as compared to baseline||||< 0.0001
70858319|NCT01083173|141202700|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||CD4 cell counts at 48 weeks as compared to baseline||||< 0.0001
70858320|NCT02554279|141202712|NON_INFERIORITY|The study had at least 80% power, to demonstrate the non-inferiority of menotropin to recombinant FSH at 1-sided significance level of 0.025 with a -12% non-inferiority margin.|Absolute difference|4.7|||||TWO_SIDED|95.0|-2.7|12.1||||||Null hypothesis was defined as the difference between ongoing pregnancy rate of participants randomized and treated with menotropin and recombinant FSH, as ≤-12%.||12.1|-2.7|
70858321|NCT02554279|141202713|OTHER||Absolute difference|1.2|||||TWO_SIDED|95.0|-6.6|8.9||||||||8.9|-6.6|
70858322|NCT02554279|141202714|OTHER||Absolute difference|3.8|||||TWO_SIDED|95.0|-3.8|11.3||||||||11.3|-3.8|
70858323|NCT02554279|141202715|OTHER||Absolute difference|-9.5|||||TWO_SIDED|95.0|-19.2|0.2||||||||0.2|-19.2|
70858324|NCT01933789|141202724|SUPERIORITY||Probit regression coefficient|1.145|||<|0.001|TWO_SIDED|95.0|0.844|1.446||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Bivariate model; there were no confounders.|Control group coded 0; intervention group coded 1.|||1.446|0.844|<0.001
70858325|NCT01933789|141202725|SUPERIORITY||Probit regression coefficient|1.251|||<|0.001|TWO_SIDED|95.0|0.92|1.583||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Bivariate model; there were no confounders.|Control group coded 0; intervention group coded 1.|||1.583|0.920|<0.001
70946622|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.216||0.783|TWO_SIDED|95.0|-0.37|0.48|||Mixed Models Analysis|||Depression/Dysphoria||0.48|-0.37|0.783
70858326|NCT01933789|141202726|SUPERIORITY||Probit regression coefficient|1.381|||<|0.001|TWO_SIDED|95.0|1.046|1.715||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Bivariate model; there were no confounders.|Control group coded 0; intervention group coded 1.|||1.715|1.046|<0.001
70858327|NCT01933789|141202728|SUPERIORITY||Probit regression coefficient|0.334||||0.073|TWO_SIDED|95.0|-0.031|0.699||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for the patient's treatment preference (focus on life extension vs. comfort care).|Control group coded 0; intervention group coded 1.|Occurrence of goal-concordant care||0.699|-0.031|0.073
70858328|NCT01933789|141202729|SUPERIORITY||Probit regression coefficient|0.481||||0.017|TWO_SIDED|95.0|0.085|0.877||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for the patient's treatment preference (focus on life extension vs. comfort care).|Control group coded 0; intervention group coded 1.|||0.877|0.085|0.017
70858329|NCT01933789|141202730|SUPERIORITY||Probit regression coefficient|2.022||||0.01|TWO_SIDED|95.0|0.476|3.569||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for the latent variable as measured at baseline.|Control group coded 0; intervention group coded 1.|||3.569|0.476|0.010
70858330|NCT01933789|141202731|SUPERIORITY||Tobit regression coefficient|2.209||||0.001|TWO_SIDED|95.0|0.939|3.479||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about patient's feelings about getting sicker.~Variable with range 0-11, defined as censored from below because of strong floor effect."||3.479|0.939|0.001
70946623|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.226||0.64|TWO_SIDED|95.0|-0.55|0.34|||Mixed Models Analysis|||Depression/Dysphoria||0.34|-0.55|0.640
70946624|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.236||0.592|TWO_SIDED|95.0|-0.59|0.34|||Mixed Models Analysis|||Depression/Dysphoria||0.34|-0.59|0.592
70858331|NCT01933789|141202731|SUPERIORITY||Tobit regression coefficient|1.237||||0.122|TWO_SIDED|95.0|-0.33|2.804||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about details of getting sicker.~Variable with range 0-11, defined as censored from below because of strong floor effect."||2.804|-0.330|0.122
70858332|NCT01933789|141202731|SUPERIORITY||Tobit regression coefficient|2.329||||0.098|TWO_SIDED|95.0|-0.426|5.083||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline and clinician specialty.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about how long the patient might have to live.~Variable with range 0-11, defined as censored from below because of strong floor effect."||5.083|-0.426|0.098
70946625|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.197||0.993|TWO_SIDED|95.0|-0.39|0.39|||Mixed Models Analysis|||Anxiety||0.39|-0.39|0.993
71127788|NCT01815840|141760311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.3|||||TWO_SIDED|95.0|-22.2|5.7|||||Asymptotic confidence intervals are presented for the difference between treatment arms.|The mean difference in the mean relative reduction between treatment arms, along with the corresponding 95% confidence interval, was estimated by fitting an ANCOVA model with treatment as main effect and the following covariates: number of basal cell carcinomas at baseline, geographical region, immunosuppression status, confirmed basal cell carcinoma nevus syndrome.||5.7|-22.2|
71127789|NCT00434642|141760357|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.484|||<|0.0001|TWO_SIDED|95.0|0.388|0.605||A P-value \< 0.05 was required for significance.|Log Rank|The analysis was stratified for time since the last platinum therapy (6-12, \> 12 months) and cytoreductive surgery for recurrent disease (yes, no).|The hazard ratio was estimated using Cox regression. The hazard ratio is relative to the carboplatin and gemcitabine + placebo group.|The null hypothesis was that there was no difference between the 2 treatment groups, ie, that the hazard ratio is equal to 1. The alternative hypothesis was that progression free survival was longer in the carboplatin and gemcitabine + bevacizumab group, ie, that the hazard ratio is not equal to 1.||0.605|0.388|<0.0001
71127790|NCT00434642|141760358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.1|||<|0.0001|TWO_SIDED|95.0|13.0|29.2||A P-value \< 0.05 was required for significance.|Cochran-Mantel-Haenszel|The analysis was stratified for time since the last platinum therapy (6-12, \> 12 months) and cytoreductive surgery for recurrent disease (yes, no).|The difference in response rates and the 95% confidence intervals for response rates were computed using the normal approximation to the binomial distribution.|The null hypothesis was that there was no difference in the percentage of patients with an objective response between the 2 treatment groups. The alternative hypothesis was that a larger percentage of patients had an objective response in the carboplatin and gemcitabine + bevacizumab group.||29.2|13.0|<0.0001
71127791|NCT00434642|141760360|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.952||||0.6479|TWO_SIDED|95.0|0.771|1.176||Summaries of duration of overall survival (median, percentiles) were estimated from Kaplan-Meier curves. The 95% confidence interval for the median was computed using the method of Brookmeyer and Crowley.|Log Rank|The analysis was stratified for time since the last platinum therapy (≤12, \>12 months) and cytoreductive surgery for recurrent disease (Yes, No).|The hazard ratio was estimated using Cox regression. The hazard ratio is relative to the carboplatin and gemcitabine + placebo group.|||1.176|0.771|0.6479
71127792|NCT00789672|141760395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_DEVIATION|4.7|||TWO_SIDED|95.0|-6.0|1.0||||||Given this was pilot study, no formal sample size estimates were calculated.||1|-6|
71127793|NCT01463072|141760425|OTHER||Percent|35.0|||||TWO_SIDED|95.0|21.0|52.0|||||35% of participants were responders (CR+PR).|||52|21|
71127794|NCT01463072|141760427|SUPERIORITY||Odds Ratio (OR)|5.8||||0.01|TWO_SIDED|95.0|1.3|33.1|||Fisher Exact||Ratio is intermediate/high toxicity risk over low toxicity risk|CARG chemotherapy toxicity risk predictive of chemotherapy toxicity (grade 3)||33.1|1.3|0.01
71127795|NCT01463072|141760427|SUPERIORITY||Ratio of group means|1.38||||0.02|TWO_SIDED|95.0|1.04|1.8|||t-test, 2 sided||Ratio is dose reduction over no dose reduction.|CARG chemotherapy toxicity risk predictive of dose reduction due to chemotherapy toxicity||1.80|1.04|0.02
71127796|NCT01192412|141760448|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.77|1.35||||||We estimated that with a sample size of 514 per group, the study would have 80% power, at a two-tailed alpha level of 0.05, assuming primary outcome rates of 33% in the tight-control group and 25% in the less-tight-control group, a 10% rate of crossover, a 1% loss to follow-up, and two interim analyses, as calculated with the chi-square test with the use of East software (Cytel) and the Lan-DeMets spending function with O'Brien-Fleming-type boundaries for early stopping.||1.35|0.77|
71127797|NCT01192412|141760449|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74|||||TWO_SIDED|95.0|0.79|3.84||||||||3.84|0.79|
71127798|NCT03194646|141760515|OTHER||Mean Difference (Final Values)|-1.85|||||TWO_SIDED|95.0|-2.44|-1.26||||||||-1.26|-2.44|
71127799|NCT03194646|141760515|OTHER||Mean Difference (Final Values)|-2.34|||||TWO_SIDED|95.0|-2.87|-1.8||||||||-1.80|-2.87|
71127800|NCT03194646|141760515|OTHER||Mean Difference (Final Values)|-1.81|||||TWO_SIDED|95.0|-2.51|-1.1||||||||-1.10|-2.51|
71127801|NCT04071158|141760546|SUPERIORITY||Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.4|2.8||||||Difference in percentage||2.8|-1.4|
71127802|NCT04071158|141760547|SUPERIORITY||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-4.6|1.7||||||Difference in percentage||1.7|-4.6|
71127803|NCT04071158|141760548|SUPERIORITY||Ratio of Geometric Mean|0.8|||||TWO_SIDED|95.0|0.64|1.0||||||Anti-PT: Ratio of geometric mean was calculated by dividing the GMC of RSV vaccine with aluminum hydroxide with Tdap arm by GMC of placebo/Tdap arm.||1.00|0.64|
71127804|NCT04071158|141760548|SUPERIORITY||Ratio of Geometric Mean|0.59|||||TWO_SIDED|95.0|0.5|0.7||||||Anti-PT: Ratio of geometric mean was calculated by dividing the GMC of RSV vaccine with aluminum hydroxide with Tdap arm by GMC of placebo/Tdap arm.||0.70|0.50|
70946626|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.205||0.29|TWO_SIDED|95.0|-0.19|0.62|||Mixed Models Analysis|||Anxiety||0.62|-0.19|0.290
70946627|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.215||0.722|TWO_SIDED|95.0|-0.5|0.35|||Mixed Models Analysis|||Anxiety||0.35|-0.50|0.722
70946628|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.097||0.246|TWO_SIDED|95.0|-0.3|0.08|||Mixed Models Analysis|||Elation/Euphoria||0.08|-0.30|0.246
71127805|NCT04071158|141760548|SUPERIORITY||Ratio of Geometric Mean|0.6|||||TWO_SIDED|95.0|0.48|0.76||||||Anti-PT: Ratio of geometric mean was calculated by dividing the GMC of RSV vaccine with aluminum hydroxide with Tdap arm by GMC of placebo/Tdap arm.||0.76|0.48|
71127806|NCT04071158|141760549|SUPERIORITY||Ratio of Geometric Mean|0.97|||||TWO_SIDED|95.0|0.84|1.13|||||Ratio of geometric mean was calculated by dividing GMT of RSV vaccine with aluminum hydroxide with Tdap arm by GMT of RSV vaccine with aluminum hydroxide with placebo arm.|2.0-fold margin (related to primary objective): primary objective was demonstrated if the lower limit of 95% confidence interval (CI) from the ratio of titers with 50 percent cut off from two treatment groups greater than (\>) 0.5.||1.13|0.84|
71127807|NCT04071158|141760550|SUPERIORITY||Ratio of Geometric Mean|0.96|||||TWO_SIDED|95.0|0.81|1.14|||||Ratio of geometric mean was calculated by dividing GMT of RSV vaccine with aluminum hydroxide with Tdap arm by GMT of RSV vaccine with aluminum hydroxide with placebo arm.|2.0-fold margin (related to primary objective): primary objective was demonstrated if the lower limit of 95% CI from the ratio of titers with 50 percent cut off from two treatment groups \> 0.5.||1.14|0.81|
71127808|NCT04071158|141760555|SUPERIORITY||Ratio of Geometric Mean|0.97|||||TWO_SIDED|95.0|0.84|1.13|||||Ratio of geometric mean was calculated by dividing GMT of RSV vaccine with aluminum hydroxide with Tdap arm by GMT of RSV vaccine with aluminum hydroxide with placebo arm.|1.5-fold margin (related to secondary objective): secondary objective was demonstrated if the lower limit of 95% CI from the ratio of titers with 50 percent cut off from two treatment groups \> 0.67.||1.13|0.84|
71127809|NCT04071158|141760556|SUPERIORITY||Ratio of Geometric Mean|0.96|||||TWO_SIDED|95.0|0.81|1.14|||||Ratio of geometric mean was calculated by dividing GMT of RSV vaccine with aluminum hydroxide with Tdap arm by GMT of RSV vaccine with aluminum hydroxide with placebo arm.|1.5-fold margin (related to secondary objective): secondary objective was demonstrated if the lower limit of 95% CI from the ratio of titers with 50 percent cut off from two treatment groups \> 0.67.||1.14|0.81|
71127810|NCT01178099|141760561|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.05|||||TWO_SIDED|90.0|0.829|1.33|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 10 mg SD (overall).|||1.33|0.829|
71127811|NCT01178099|141760561|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.895|||||TWO_SIDED|90.0|0.718|1.12|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 7.5 mg MD.|||1.12|0.718|
71127812|NCT01178099|141760561|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.905|||||TWO_SIDED|90.0|0.656|1.25|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 5 mg MD.|||1.25|0.656|
71127813|NCT01178099|141760562|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.953|||||TWO_SIDED|90.0|0.664|1.37|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 10 mg SD (overall).|||1.37|0.664|
70858333|NCT01933789|141202731|SUPERIORITY||Tobit regression coefficient|1.573||||0.352|TWO_SIDED|95.0|-1.742|4.887||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Pts clustered under clins. Adjusted for outcome variable as measured at baseline: pt. minority status, education, income; clinician type \& specialty.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about what dying might be like.~Variable with range 0-11, defined as censored from below because of strong floor effect."||4.887|-1.742|0.352
70858334|NCT01933789|141202731|SUPERIORITY||Tobit regression coefficient|4.625|||<|0.001|TWO_SIDED|95.0|2.06|7.19||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about patient's involvement in end-of-life treatment decisions.~Variable with range 0-11, defined as censored from below because of strong floor effect."||7.190|2.060|<0.001
71127814|NCT01178099|141760562|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.612|||||TWO_SIDED|90.0|0.436|0.86|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 7.5 mg MD.|||0.860|0.436|
70946629|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.101||0.175|TWO_SIDED|95.0|-0.34|0.06|||Mixed Models Analysis|||Elation/Euphoria||0.06|-0.34|0.175
71127815|NCT01178099|141760562|SUPERIORITY_OR_OTHER||Geometric LS Means, SCD:Healthy|1.03|||||TWO_SIDED|90.0|0.625|1.68|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 5 mg MD.|||1.68|0.625|
71127816|NCT01178099|141760563|SUPERIORITY_OR_OTHER|||||||0.07||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.070
71127817|NCT01178099|141760564|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.52|||||TWO_SIDED|90.0|1.1|2.1|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 10 mg SD (overall) for the R-95913 metabolite.|||2.10|1.10|
71127818|NCT01178099|141760564|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.44|||||TWO_SIDED|90.0|1.06|1.94|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 7.5 mg MD for the R-95913 metabolite.|||1.94|1.06|
71127819|NCT01178099|141760564|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.43|||||TWO_SIDED|90.0|0.918|2.21|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 5 mg MD for the R-95913 metabolite.|||2.21|0.918|
70946630|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.106||0.482|TWO_SIDED|95.0|-0.28|0.13|||Mixed Models Analysis|||Elation/Euphoria||0.13|-0.28|0.482
70946631|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|-0.45|STANDARD_ERROR_OF_MEAN|0.266||0.091|TWO_SIDED|95.0|-0.97|0.07|||Mixed Models Analysis|||Apathy/Indifference||0.07|-0.97|0.091
70946632|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.278||0.248|TWO_SIDED|95.0|-0.87|0.23|||Mixed Models Analysis|||Apathy/Indifference||0.23|-0.87|0.248
71127820|NCT01178099|141760564|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.971|||||TWO_SIDED|90.0|0.742|1.27|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 10 mg SD (overall) for the R-106583 metabolite.|||1.27|0.742|
71127821|NCT01178099|141760564|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.815|||||TWO_SIDED|90.0|0.633|1.05|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 7.5 mg MD for the R-106583 metabolite.|||1.05|0.633|
71127822|NCT01178099|141760564|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.952|||||TWO_SIDED|90.0|0.658|1.38|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 5 mg MD for the R-106583 metabolite.|||1.38|0.658|
71127823|NCT01178099|141760564|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.17|||||TWO_SIDED|90.0|0.833|1.65|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 10 mg SD (overall) for the R-119251 metabolite.|||1.65|0.833|
71127824|NCT01178099|141760564|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.07|||||TWO_SIDED|90.0|0.779|1.48|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 7.5 mg MD for the R-119251 metabolite.|||1.48|0.779|
71127825|NCT01178099|141760564|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.813|||||TWO_SIDED|95.0|0.51|1.3|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 5 mg MD for the R-119251 metabolite.|||1.30|0.510|
71127826|NCT01178099|141760565|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.018
71127827|NCT01178099|141760566|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.060
71127828|NCT01178099|141760567|SUPERIORITY_OR_OTHER|||||||0.219||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.219
71127829|NCT01178099|141760568|SUPERIORITY_OR_OTHER|||||||0.177||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.177
71127830|NCT01178099|141760569|SUPERIORITY_OR_OTHER|||||||0.168||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.168
71127831|NCT01178099|141760570|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.5|||||TWO_SIDED|90.0|1.01|2.22|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 10 mg SD (overall) for the R-95913 metabolite.|||2.22|1.01|
71127832|NCT01178099|141760570|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.09|||||TWO_SIDED|90.0|0.751|1.58|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 7.5 mg MD for the R-95913 metabolite.|||1.58|0.751|
71127833|NCT01178099|141760570|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.87|||||TWO_SIDED|90.0|1.09|3.2|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 5 mg MD for the R-95913 metabolite.|||3.20|1.09|
71127834|NCT01178099|141760570|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.873|||||TWO_SIDED|90.0|0.66|1.15|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 10 mg SD (overall) for the R-106583 metabolite.|||1.15|0.660|
71127835|NCT01178099|141760570|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.681|||||TWO_SIDED|90.0|0.524|0.886|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 7.5 mg MD for the R-106583 metabolite.|||0.886|0.524|
71127836|NCT01178099|141760570|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.898|||||TWO_SIDED|90.0|0.612|1.32|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 5 mg MD for the R-106583 metabolite.|||1.32|0.612|
71127837|NCT01178099|141760570|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.06|||||TWO_SIDED|90.0|0.773|1.46|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 10 mg SD (overall) for the R-119251 metabolite.|||1.46|0.773|
71127838|NCT01178099|141760570|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.785|||||TWO_SIDED|90.0|0.582|1.06|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 7.5 mg MD for the R-119251 metabolite.|||1.06|0.582|
71127839|NCT01178099|141760570|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.0|||||TWO_SIDED|90.0|0.648|1.55|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 5 mg MD for the R-119251 metabolite.|||1.55|0.648|
71127840|NCT01178099|141760571|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.060
71127841|NCT01178099|141760572|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||This is the p-value for PRI by flow cytometry. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error|ANCOVA|||||||0.086
71127842|NCT01178099|141760572|SUPERIORITY_OR_OTHER|||||||0.679||95.0||||This is the p-value for PRI by ELISA. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error|ANCOVA|||||||0.679
71127843|NCT01178099|141760573|SUPERIORITY_OR_OTHER|||||||0.396||95.0||||This is the p-value for AU\*min to 6.5 µM ADP. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.396
71127844|NCT01178099|141760573|SUPERIORITY_OR_OTHER|||||||0.288||95.0||||This is the p-value for AU\*min to 20 µM ADP. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.288
71127845|NCT01178099|141760573|SUPERIORITY_OR_OTHER|||||||0.095||95.0||||This is the p-value for AU\*min to Collagen. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.095
71127846|NCT01178099|141760573|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||This is the p-value for AU\*min to TRAP-6. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.086
71127847|NCT01178099|141760574|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.083
71127848|NCT01178099|141760575|SUPERIORITY_OR_OTHER|||||||0.124||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.124
71127849|NCT01641822|141760584|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.743||||0.25|TWO_SIDED|95.0|0.446|1.238|||Negative binomial regression|||Ratio between rates||1.238|0.446|0.25
71127850|NCT01641822|141760585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.33||||0.16|TWO_SIDED|95.0|-0.55|3.2||The p-value is from an MMRM analysis. The model includes terms for baseline value, previous exacerbations (1, 2, ≥ 3), treatment, visit (categorical), and treatment by visit interaction.|Mixed Models Analysis|||Difference in change in FEV1 % predicted||3.2|-0.55|0.16
71127851|NCT01641822|141760586|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Fisher Exact|||Comparison of percentages||||0.67
71127852|NCT01641822|141760587|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.71|TWO_SIDED|95.0|0.5|1.59|||Log Rank|||Comparison of time to exacerbation||1.59|0.50|0.71
70872045|NCT01652703|141229482|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-61.35|STANDARD_ERROR_OF_MEAN|2.93|<|0.001|TWO_SIDED|95.0|-67.14|-55.56||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-55.56|-67.14|<0.001
71127853|NCT01641822|141760588|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.642||||0.14|TWO_SIDED|95.0|0.355|1.164|||Negative binomial regression|||Comparison of hospitalization rate||1.164|0.355|0.14
71127854|NCT01641822|141760589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.06||||0.21|TWO_SIDED|95.0|-1.71|7.82||The p-value is from an MMRM analysis. The model includes terms for baseline value, previous exacerbations (1, 2, ≥ 3), treatment, visit (categorical), and treatment by visit interaction.|Mixed Models Analysis|||Difference in change in CFQ-R RSS||7.82|-1.71|0.21
71127855|NCT00454584|141760590|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).||||||<0.001
71127856|NCT00454584|141760590|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||To control the overall type I error rate at 0.05 level in the primary endpoint analysis, a step-down test procedure was applied. First, ustekinumab 90 mg and etanercept were compared. Then ustekinumab 45 mg and etanercept would be compared.|Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and etanercept at an overall significant level of 0.05. Sample Size: Assuming the PASI 75 response rates of ustekinumab 90 mg, 45 mg, etanercept are 65%, 64%, and 50% , respectively, with 325 participants each in the ustekinumab 90 mg and etanercept groups, the power to detect a treatment difference is 97%. With 200 participants in the ustekinumab 45 mg group, the complete power to further detect a treatment difference was 87%.||||0.012
71127857|NCT00454584|141760591|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).||||||<0.001
71127858|NCT00454584|141760591|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and etanercept at an overall significant level of 0.05.||||<0.001
71127859|NCT00454584|141760592|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).||||||<0.001
70858335|NCT01933789|141202731|SUPERIORITY||Tobit regression coefficient|2.404||||0.002|TWO_SIDED|95.0|0.898|3.909||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about things in life that are important to the patient.~Variable with range 0-11, defined as censored from below because of strong floor effect."||3.909|0.898|0.002
70858336|NCT01933789|141202731|SUPERIORITY||Tobit regression coefficient|2.455||||0.075|TWO_SIDED|95.0|-0.25|5.159||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline and clinician type.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about patient's religious/spiritual beliefs.~Variable with range 0-11, defined as censored from below because of strong floor effect."||5.159|-0.250|0.075
70858337|NCT01933789|141202732|SUPERIORITY||Probit regression coefficient|-0.103||||0.369|TWO_SIDED|95.0|-0.327|0.122||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for baseline level of the latent depression variable and for the patient racial/ethnic minority status.|Control group coded 0; intervention group coded 1.|Symptoms of depression - Two-indicator latent variable with measurement invariance imposed between groups and over time.||0.122|-0.327|0.369
70858338|NCT01933789|141202733|SUPERIORITY||Probit regression coefficient|0.263||||0.536|TWO_SIDED|95.0|-0.571|1.097||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered robust linear regression|Patients clustered under clinicians. Adjusted for baseline level of the PHQ-8 composite score.|Control group coded 0; intervention group coded 1.|Symptoms of depression: standard PHQ-8 composite score.||1.097|-0.571|0.536
70858339|NCT01933789|141202734|SUPERIORITY||Probit regression coefficient|0.208||||0.106|TWO_SIDED|95.0|-0.044|0.461||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Pts clustered under clins. Adjusted for baseline level of the latent depression var; pt age, minority status, education, health status; clin specialty|Control group coded 0; intervention group coded 1.|Symptoms of depression: Two-indicator latent variable with measurement invariance imposed between groups and over time||0.461|-0.044|0.106
70858340|NCT01933789|141202735|SUPERIORITY||Probit regression coefficient|0.446||||0.343|TWO_SIDED|95.0|-0.476|1.368||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered robust linear regression|Patients clustered under clinicians. Adjusted for baseline level of the PHQ-8 composite score and clinician specialty.|Control group coded 0; intervention group coded 1.|Symptoms of depression: Standard PHQ-8 composite score||1.368|-0.476|0.343
70858341|NCT01933789|141202736|SUPERIORITY||Probit regression coefficient|-0.034||||0.734|TWO_SIDED|95.0|-0.232|0.163||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for baseline level of the latent anxiety variable.|Control group coded 0; intervention group coded 1.|Symptoms of anxiety: Two-indicator latent variable with measurement invariance imposed between groups and over time||0.163|-0.232|0.734
70946633|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.29||0.516|TWO_SIDED|95.0|-0.76|0.38|||Mixed Models Analysis|||Apathy/Indifference||0.38|-0.76|0.516
70946634|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.114||0.875|TWO_SIDED|95.0|-0.21|0.24|||Mixed Models Analysis|||Disinhibition||0.24|-0.21|0.875
70946635|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|0.34|STANDARD_ERROR_OF_MEAN|0.119||0.005|TWO_SIDED|95.0|0.1|0.57|||Mixed Models Analysis|||Disinhibition||0.57|0.10|0.005
71127860|NCT00454584|141760592|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and etanercept at an overall significant level of 0.05.||||<0.001
71127861|NCT00599638|141760598|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.306||0.391|TWO_SIDED|80.0|-0.31|0.48|||Mixed Models Analysis|||||0.48|-0.31|0.3910
71127862|NCT00599638|141760598|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.357||0.0002|TWO_SIDED|80.0|-1.78|-0.86|||Mixed Models Analysis|||||-0.86|-1.78|0.0002
71127863|NCT00599638|141760599|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0055||||0.4959|TWO_SIDED|80.0|0.3|1.71|||Regression, Logistic|||The statistical analysis was performed compositely for all categories.||1.71|0.30|0.4959
71127864|NCT00599638|141760599|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.0763||||0.0011|TWO_SIDED|80.0|1.69|8.46|||Regression, Logistic|||The statistical analysis was performed compositely for all categories.||8.46|1.69|0.0011
71127865|NCT00599638|141760601|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|1.18|STANDARD_ERROR_OF_MEAN|2.819||0.338|TWO_SIDED|80.0|-2.47|4.84|||Mixed Models Analysis|||||4.84|-2.47|0.3380
71127866|NCT00599638|141760601|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-9.65|STANDARD_ERROR_OF_MEAN|3.268||0.0022|TWO_SIDED|80.0|-13.89|-5.42|||Mixed Models Analysis|||||-5.42|-13.89|0.0022
71127867|NCT04484207|141760613|SUPERIORITY|||||||0.031|||||||GEE|||||||0.031
71127868|NCT03037983|141760615|SUPERIORITY||Mean Difference (Net)|1.38||||0.849|TWO_SIDED||||||t-test, 2 sided|||||||.849
71127869|NCT03037983|141760617|SUPERIORITY||Mean Difference (Net)|0.5||||0.782|TWO_SIDED|||||t = 0.287|t-test, 2 sided|||||||.782
71127870|NCT04016077|141760649|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Geometric Means|118.5|||||TWO_SIDED|90.0|87.96|159.64|||ANOVA|||||159.64|87.96|
71127871|NCT04016077|141760650|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Geometric Means|104.0|||||TWO_SIDED|90.0|74.48|145.23|||ANOVA|||||145.23|74.48|
71127872|NCT04118595|141760661|SUPERIORITY|||||||0.13|||||||ANCOVA|||||||0.13
71127873|NCT04118595|141760662|SUPERIORITY|||||||0.41|||||||ANCOVA|||||||0.41
71127874|NCT04118595|141760663|SUPERIORITY|||||||0.08|||||||ANCOVA|||||||0.08
71127875|NCT04118595|141760664|SUPERIORITY|||||||0.64|||||||ANCOVA|||||||0.64
71127876|NCT04118595|141760665|SUPERIORITY|||||||0.57|||||||ANCOVA|||||||0.57
71127877|NCT04118595|141760666|SUPERIORITY|||||||0.43|||||||ANCOVA|||||||0.43
71127878|NCT04118595|141760667|SUPERIORITY|||||||0.19|||||||ANCOVA|||||||0.19
70946636|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.125||0.761|TWO_SIDED|95.0|-0.21|0.28|||Mixed Models Analysis|||Disinhibition||0.28|-0.21|0.761
70946637|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.181||0.183|TWO_SIDED|95.0|-0.6|0.12|||Mixed Models Analysis|||Irritability/Lability||0.12|-0.60|0.183
70946638|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.189||0.765|TWO_SIDED|95.0|-0.43|0.31|||Mixed Models Analysis|||Irritability/Lability||0.31|-0.43|0.765
71127879|NCT04118595|141760668|SUPERIORITY|||||||0.15|||||||ANCOVA|||||||0.15
71127880|NCT04118595|141760669|SUPERIORITY|||||||0.04|||||||ANCOVA|||||||0.04
71127881|NCT04118595|141760670|SUPERIORITY|||||||0.36|||||||ANCOVA|||||||0.36
71127882|NCT03624127|141760682|SUPERIORITY||Odds Ratio (OR)|18.71|||<|0.0001|TWO_SIDED|95.0|9.51|36.81|||Cochran-Mantel-Haenszel|||||36.81|9.51|<0.0001
71127883|NCT03624127|141760683|SUPERIORITY||Odds Ratio (OR)|11.09|||<|0.0001|TWO_SIDED|95.0|6.49|18.95|||Cochran-Mantel-Haenszel|||||18.95|6.49|<0.0001
71127884|NCT03624127|141760684|SUPERIORITY||Odds Ratio (OR)|16.15|||<|0.0001|TWO_SIDED|95.0|6.91|37.72|||Cochran-Mantel-Haenszel|||||37.72|6.91|<0.0001
71127885|NCT03624127|141760684|SUPERIORITY||Odds Ratio (OR)|2.4||||0.0002|TWO_SIDED|95.0|1.51|3.6|||Cochran-Mantel-Haenszel|||||3.60|1.51|0.0002
71127886|NCT03624127|141760685|SUPERIORITY||Odds Ratio (OR)|31.3|||<|0.0001|TWO_SIDED|95.0|4.09|239.36|||Cochran-Mantel-Haenszel|||||239.36|4.09|<0.0001
71127887|NCT03624127|141760686|SUPERIORITY||Odds Ratio (OR)|4.52|||<|0.0001|TWO_SIDED|95.0|2.07|9.84|||Cochran-Mantel-Haenszel|||||9.84|2.07|<0.0001
71127888|NCT03624127|141760686|SUPERIORITY||Odds Ratio (OR)|39.54|||<|0.0001|TWO_SIDED|95.0|5.29|295.75|||Cochran-Mantel-Haenszel|||||295.75|5.29|<0.0001
71127889|NCT03624127|141760687|SUPERIORITY||Adjusted Mean Difference|-8.8|STANDARD_ERROR_OF_MEAN|2.0|<|0.0001|TWO_SIDED|95.0|-12.8|-4.9|||ANCOVA|||||-4.9|-12.8|<0.0001
71127890|NCT03624127|141760688|SUPERIORITY||Odds Ratio (OR)|13.67||||0.0013|TWO_SIDED|95.0|1.77|105.5|||Cochran-Mantel-Haenszel|||||105.50|1.77|0.0013
71127891|NCT03624127|141760688|SUPERIORITY||Odds Ratio (OR)|1.84||||0.1702|TWO_SIDED|95.0|0.76|4.42|||Cochran-Mantel-Haenszel|||||4.42|0.76|0.1702
71127892|NCT03624127|141760689|SUPERIORITY||Odds Ratio (OR)|6.04|||<|0.0001|TWO_SIDED|95.0|3.46|10.53|||Cochran-Mantel-Haenszel|||||10.53|3.46|<0.0001
71127893|NCT03624127|141760690|SUPERIORITY||Odds Ratio (OR)|2.84||||0.1049|TWO_SIDED|95.0|0.73|10.96|||Cochran-Mantel-Haenszel|||||10.96|0.73|0.1049
71127894|NCT03624127|141760691|SUPERIORITY||Odds Ratio (OR)|2.64|||<|0.0001|TWO_SIDED|95.0|1.78|3.91|||Cochran-Mantel-Haenszel|||||3.91|1.78|<0.0001
71127895|NCT03624127|141760692|SUPERIORITY||Odds Ratio (OR)|2.53|||<|0.0001|TWO_SIDED|95.0|1.7|3.78|||Cochran-Mantel-Haenszel|||||3.78|1.70|<0.0001
71127896|NCT03624127|141760693|SUPERIORITY||Odds Ratio (OR)|11.92|||<|0.0001|TWO_SIDED|95.0|6.69|21.25|||Cochran-Mantel-Haenszel|||||21.25|6.69|<0.0001
71127897|NCT03624127|141760693|SUPERIORITY||Odds Ratio (OR)|3.65|||<|0.0001|TWO_SIDED|95.0|2.21|6.04|||Cochran-Mantel-Haenszel|||||6.04|2.21|<0.0001
71127898|NCT03624127|141760694|SUPERIORITY||Odds Ratio (OR)|3.23|||<|0.0001|TWO_SIDED|95.0|2.16|4.83|||Cochran-Mantel-Haenszel|||||4.83|2.16|<0.0001
71127899|NCT03624127|141760695|SUPERIORITY||Odds Ratio (OR)|3.76|||<|0.0001|TWO_SIDED|95.0|2.53|5.6|||Cochran-Mantel-Haenszel|||||5.60|2.53|<0.0001
71127900|NCT03624127|141760696|SUPERIORITY||Odds Ratio (OR)|2.63|||<|0.0001|TWO_SIDED|95.0|1.71|4.05|||Cochran-Mantel-Haenszel|||||4.05|1.71|<0.0001
71127901|NCT03624127|141760697|SUPERIORITY||Odds Ratio (OR)|3.03|||<|0.0001|TWO_SIDED|95.0|1.96|4.69|||Cochran-Mantel-Haenszel|||||4.69|1.96|<0.0001
71127902|NCT03624127|141760698|SUPERIORITY||Odds Ratio (OR)|3.11|||<|0.0001|TWO_SIDED|95.0|2.06|4.69|||Cochran-Mantel-Haenszel|||||4.69|2.06|<0.0001
71127903|NCT03624127|141760699|SUPERIORITY||Odds Ratio (OR)|2.55||||0.0002|TWO_SIDED|95.0|1.55|4.19|||Cochran-Mantel-Haenszel|||||4.19|1.55|0.0002
71127904|NCT00788710|141760715|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
70858342|NCT01933789|141202737|SUPERIORITY||Tobit regression coefficient|0.041||||0.935|TWO_SIDED|95.0|-0.946|1.028||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Pts clustered under clins. Clustered Tobit regression because strong floor effect on composite score. Adjusted for baseline level of composite score.|Control group coded 0; intervention group coded 1.|Symptoms of anxiety: Standard GAD-7 composite score||1.028|-0.946|0.935
70858343|NCT01933789|141202738|SUPERIORITY||Probit regression coefficient|-0.042||||0.689|TWO_SIDED|95.0|-0.247|0.163||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for baseline level of the latent anxiety variable.|Control group coded 0; intervention group coded 1.|Symptoms of anxiety: Two-indicator latent variable with measurement invariance imposed between groups and over time||0.163|-0.247|0.689
70858344|NCT01933789|141202739|SUPERIORITY||Tobit regression coefficient|-0.105||||0.852|TWO_SIDED|95.0|-1.204|0.995||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians. Clustered Tobit regression because of strong floor effect on composite score."|Clustered Tobit regression|Adjusted for baseline level of the GAD-7 composite score.|Control group coded 0; intervention group coded 1.|||0.995|-1.204|0.852
71127905|NCT00788710|141760715|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
71127906|NCT00788710|141760716|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
70872046|NCT01652703|141229482|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-47.53|STANDARD_ERROR_OF_MEAN|2.98|<|0.001|TWO_SIDED|95.0|-53.41|-41.65||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-41.65|-53.41|<0.001
71127907|NCT00788710|141760716|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
71127908|NCT00788710|141760717|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
71127909|NCT00788710|141760717|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
70858345|NCT01933789|141202740|SUPERIORITY||probit regression coefficient|-0.221||||0.418|TWO_SIDED|95.0|-0.923|0.482||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|Adjusted for confounding by patient race and health status and by clinician type and specialty|Control group coded 0; intervention group coded 1.|||0.482|-0.923|0.418
70858346|NCT01933789|141202741|SUPERIORITY||probit regression coefficient|0.175||||0.568|TWO_SIDED|95.0|-0.613|0.962||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.962|-0.613|0.568
70858347|NCT01933789|141202742|SUPERIORITY||probit regression coefficient|0.14||||0.592|TWO_SIDED|95.0|-0.534|0.815||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment|Control group coded 0; intervention group coded 1.|||0.815|-0.534|0.592
71127910|NCT00006400|141760718|SUPERIORITY|The primary analysis was done using an intention-to-treat principle.||||||0.21||||||The spleen endpoint was to be tested at an overall alpha = 0.04. Originally there was a second primary outcome to be tested at alpha = 0.01, but this outcome was dropped.|Fisher Exact|||The primary analysis compared the frequency of worsening spleen function (from normal to decreased or absent, or decreased to absent) and not worsening (from decreased to decreased, normal to normal, or decreased to normal) as measured by splenic uptake on a technetium-99m (99mTc) sulfur colloid liver-spleen scan. Children with missing data or absent spleen function at baseline were excluded from the analysis (26 subjects from hydroxyurea and 23 subjects from placebo group were excluded).||||0.21
71127911|NCT00006400|141760719|SUPERIORITY|||||||0.93||||||This was originally a second primary outcome to be tested at alpha = 0.01, but was later dropped from the protocol. We analyzed the available data.|ANOVA|||The change from baseline to exit as measured by DTPA GFR were compared between treatment groups.||||0.93
71127912|NCT00006400|141760720|SUPERIORITY|||||||0.43||||||All secondary outcomes were tested at alpha=0.01|ANOVA|||The change from baseline to exit as measured by GFR (calculated using Shwartz formula) were compared between treatment groups.||||0.43
70858348|NCT01933789|141202745|SUPERIORITY||probit regression coefficient|-0.179||||0.705|TWO_SIDED|95.0|-1.398|1.04||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment|Control group coded 0; intervention group coded 1.|||1.040|-1.398|0.705
70858349|NCT01933789|141202746|SUPERIORITY||probit regression coefficient|0.123||||0.644|TWO_SIDED|95.0|-0.56|0.805||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment|Control group coded 0; intervention group coded 1.|||0.805|-0.560|0.644
70946639|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.198||0.279|TWO_SIDED|95.0|-0.18|0.61|||Mixed Models Analysis|||Irritability/Lability||0.61|-0.18|0.279
71127913|NCT00006400|141760721|SUPERIORITY|||||||0.48||||||All secondary outcomes were to be tested at alpha = 0.01|ANOVA|||The change in GFR from baseline to exit were compared between treatment groups. GFR was calculated using new Schwartz formula.||||0.48
71127914|NCT00605345|141760735|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority was met if the lower limit of the confidence interval for the response rate of the CERA group was greater than the observed response rate of the darbepoetin group minus 15%. The calculated lower limit of an acceptable difference in response rates thus, was based on the actual percentage of responders in the darbepoetin group and this percentage minus 15% had to be excluded."||||||0.5947|||||||Fisher Exact|||||||0.5947
71127915|NCT04566601|141760763|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|0.7||||0.4994|TWO_SIDED|95.0|-1.31|2.69||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 5mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95 % confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. LS means differences (95 % confidence intervals) for Week 10 are reported.||2.69|-1.31|0.4994
71127916|NCT04566601|141760763|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.6||||0.6014|TWO_SIDED|95.0|-2.6|1.51||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 25mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95 % confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. LS means differences (95 % confidence intervals) for Week 10 are reported.||1.51|-2.60|0.6014
71127917|NCT04566601|141760763|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.2||||0.8166|TWO_SIDED|95.0|-2.17|1.72||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 75mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95 % confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. LS means differences (95 % confidence intervals) for Week 10 are reported.||1.72|-2.17|0.8166
71127918|NCT04566601|141760763|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.4||||0.6588|TWO_SIDED|95.0|-1.96|1.24||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 125mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95 % confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. LS means differences (95 % confidence intervals) for Week 10 are reported.||1.24|-1.96|0.6588
71127919|NCT04566601|141760763|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction.||||||0.3914|||||||MCP-Mod sigmoid Emax model fit|Model assumption: 50% of the maximum effect is achieved at 25 mg, and 90% of the maximum effect is achieved at 75 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 1358894 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.100).||||0.3914
71127920|NCT04566601|141760763|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10 and 12) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction.||||||0.4104|||||||MCP-Mod Emax1 model fit|Model assumption: 50% of the maximum effect is achieved at 25 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 1358894 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.100).||||0.4104
71127921|NCT04566601|141760763|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction.||||||0.456|||||||MCP-Mod linear model fit|Model assumption: No parameter assumptions required.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 1358894 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.100).||||0.4560
71127922|NCT04566601|141760763|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction.||||||0.4908|||||||MCP-Mod exponential model fit|Model assumption: 5% of the maximum effect is achieved at 25 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 1358894 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.100).||||0.4908
71127923|NCT04566601|141760763|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction.||||||0.4974|||||||MCP-Mod Emax2 model fit|Model assumption: 70% of the maximum effect is achieved at 5 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 1358894 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.100).||||0.4974
71127924|NCT04566601|141760764|OTHER||Odds Ratio (OR)|0.486|||||TWO_SIDED|95.0|0.207|1.14|||||Odds Ratio of BI 1358894 5mg vs. Placebo.|The odds ratio (OR) and associated confidence intervals between the active treatment arm versus placebo were calculated through a logistic regression model that was adjusted for fixed factors of treatment, baseline ZAN-BPD strata indicator (≤18 vs. ≥19), and the continuous covariate of baseline ZAN-BPD total score.||1.140|0.207|
71127925|NCT04566601|141760764|OTHER||Odds Ratio (OR)|2.294|||||TWO_SIDED|95.0|0.829|7.48|||||Odds Ratio of BI 1358894 25mg vs. Placebo.|The odds ratio (OR) and associated confidence intervals between the active treatment arm versus placebo were calculated through a logistic regression model that was adjusted for fixed factors of treatment, baseline ZAN-BPD strata indicator (≤18 vs. ≥19), and the continuous covariate of baseline ZAN-BPD total score.||7.480|0.829|
71127926|NCT04566601|141760764|OTHER||Odds Ratio (OR)|1.753|||||TWO_SIDED|95.0|0.698|4.861|||||Odds Ratio of BI 1358894 75mg vs. Placebo.|The odds ratio (OR) and associated confidence intervals between the active treatment arm versus placebo were calculated through a logistic regression model that was adjusted for fixed factors of treatment, baseline ZAN-BPD strata indicator (≤18 vs. ≥19), and the continuous covariate of baseline ZAN-BPD total score.||4.861|0.698|
71127927|NCT04566601|141760764|OTHER||Odds Ratio (OR)|1.352|||||TWO_SIDED|95.0|0.642|2.913|||||Odds Ratio of BI 1358894 125mg vs. Placebo.|The odds ratio (OR) and associated confidence intervals between the active treatment arm versus placebo were calculated through a logistic regression model that was adjusted for fixed factors of treatment, baseline ZAN-BPD strata indicator (≤18 vs. ≥19), and the continuous covariate of baseline ZAN-BPD total score.||2.913|0.642|
70946640|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.147||0.252|TWO_SIDED|95.0|-0.12|0.46|||Mixed Models Analysis|||Aberrant Motor Behavior||0.46|-0.12|0.252
71090705|NCT02858908|141687766|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.325||||0.0054|TWO_SIDED|95.0|-0.549|-0.102|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the weekly total number of 3 minute bouts of activity per hour wear time||-0.102|-0.549|0.0054
71127928|NCT04566601|141760765|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.1||||0.9675|TWO_SIDED|95.0|-5.11|4.9||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 5mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline DERS-16 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||4.90|-5.11|0.9675
71090706|NCT02858908|141687769|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-2.162||||0.0111|TWO_SIDED|95.0|-3.731|-0.593|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the time taken (seconds) to complete the nine hole peg test for the dominant arm||-0.593|-3.731|0.0111
71090707|NCT02858908|141687769|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.955||||0.2088|TWO_SIDED|95.0|-2.525|0.614|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the time taken (seconds) to complete the nine hole peg test for the dominant arm||0.614|-2.525|0.2088
71090708|NCT02858908|141687770|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-1.77||||0.0728|TWO_SIDED|95.0|-3.71|0.18|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the subject top three concerns VAS total score (cm)||0.18|-3.71|0.0728
71090709|NCT02858908|141687770|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-1.99||||0.0456|TWO_SIDED|95.0|-3.94|-0.04|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the subject top three concerns VAS total score (cm)||-0.04|-3.94|0.0456
71127929|NCT04566601|141760765|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|0.01||||0.9969|TWO_SIDED|95.0|-5.08|5.1||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 25mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline DERS-16 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||5.10|-5.08|0.9969
71127930|NCT04566601|141760765|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.79||||0.7542|TWO_SIDED|95.0|-5.73|4.15||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 75mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline DERS-16 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||4.15|-5.73|0.7542
71127931|NCT04566601|141760765|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|1.17||||0.5683|TWO_SIDED|95.0|-2.86|5.19||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 125mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline DERS-16 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||5.19|-2.86|0.5683
70946641|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.154||0.526|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|||Aberrant Motor Behavior||0.20|-0.40|0.526
70946642|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.161||0.8|TWO_SIDED|95.0|-0.28|0.36|||Mixed Models Analysis|||Aberrant Motor Behavior||0.36|-0.28|0.800
70872047|NCT01652703|141229482|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-57.75|STANDARD_ERROR_OF_MEAN|3.03|<|0.001|TWO_SIDED|95.0|-63.73|-51.77||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-51.77|-63.73|<0.001
70946643|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.4||0.623|TWO_SIDED|95.0|-0.59|0.98|||Mixed Models Analysis|||Sleep/Nighttime Behavior Disorders||0.98|-0.59|0.623
71127932|NCT04566601|141760766|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-2.07||||0.3568|TWO_SIDED|95.0|-6.49|2.35||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 5mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline STAI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||2.35|-6.49|0.3568
71127933|NCT04566601|141760766|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|1.21||||0.6009|TWO_SIDED|95.0|-3.33|5.75||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 25mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline STAI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||5.75|-3.33|0.6009
71127934|NCT04566601|141760766|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.36||||0.8705|TWO_SIDED|95.0|-4.7|3.98||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 75mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline STAI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||3.98|-4.70|0.8705
71127935|NCT04566601|141760766|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|1.15||||0.5262|TWO_SIDED|95.0|-2.41|4.71||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 125mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline STAI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||4.71|-2.41|0.5262
71127936|NCT04566601|141760767|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-1.83||||0.0782|TWO_SIDED|95.0|-3.87|0.21||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 5mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PHQ-9 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.21|-3.87|0.0782
71127937|NCT04566601|141760767|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|0.23||||0.8266|TWO_SIDED|95.0|-1.86|2.32||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 25mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PHQ-9 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||2.32|-1.86|0.8266
71127938|NCT04566601|141760767|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.27||||0.791|TWO_SIDED|95.0|-2.28|1.74||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 75mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PHQ-9 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||1.74|-2.28|0.7910
70946644|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|-0.39|STANDARD_ERROR_OF_MEAN|0.418||0.354|TWO_SIDED|95.0|-1.21|0.44|||Mixed Models Analysis|||Sleep/Nighttime Behavior Disorders||0.44|-1.21|0.354
70858350|NCT01933789|141202747|SUPERIORITY||probit regression coefficient|-0.165||||0.908|TWO_SIDED|95.0|-3.833|3.503||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|Adjusted for confounding by patient education and health status and by clinician gender.|Control group coded 0; intervention group coded 1.|||3.503|-3.833|0.908
70946645|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.437||0.809|TWO_SIDED|95.0|-0.97|0.75|||Mixed Models Analysis|||Sleep/Nighttime Behavior Disorders||0.75|-0.97|0.809
70946646|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.376||0.79|TWO_SIDED|95.0|-0.84|0.64|||Mixed Models Analysis|||Appetite/Eating Disorders||0.64|-0.84|0.790
70946647|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.392||0.28|TWO_SIDED|95.0|-1.2|0.35|||Mixed Models Analysis|||Appetite/Eating Disorders||0.35|-1.20|0.280
70946648|NCT03305809|141393753|SUPERIORITY||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.412||0.797|TWO_SIDED|95.0|-0.7|0.92|||Mixed Models Analysis|||Appetite/Eating Disorders||0.92|-0.70|0.797
70946649|NCT03305809|141393754|SUPERIORITY||Mean Difference (Net)|-0.71|STANDARD_ERROR_OF_MEAN|0.61||0.247|TWO_SIDED|95.0|-1.91|0.49|||Mixed Models Analysis|||||0.49|-1.91|0.247
71127939|NCT04566601|141760767|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.13||||0.8743|TWO_SIDED|95.0|-1.77|1.51||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 125mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PHQ-9 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||1.51|-1.77|0.8743
71127940|NCT04566601|141760768|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.05||||0.8016|TWO_SIDED|95.0|-0.47|0.37||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 5mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline CGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.37|-0.47|0.8016
71127941|NCT04566601|141760768|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.23||||0.2929|TWO_SIDED|95.0|-0.67|0.2||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 25mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline CGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.20|-0.67|0.2929
71127942|NCT04566601|141760768|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.01||||0.9666|TWO_SIDED|95.0|-0.42|0.4||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 75mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline CGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.40|-0.42|0.9666
70946650|NCT03305809|141393754|SUPERIORITY||Mean Difference (Net)|-0.88|STANDARD_ERROR_OF_MEAN|0.631||0.164|TWO_SIDED|95.0|-2.12|0.36|||Mixed Models Analysis|||||0.36|-2.12|0.164
70946651|NCT03305809|141393754|SUPERIORITY||Mean Difference (Net)|-1.59|STANDARD_ERROR_OF_MEAN|0.663||0.017|TWO_SIDED|95.0|-2.9|-0.29|||Mixed Models Analysis|||||-0.29|-2.90|0.017
70946652|NCT03305809|141393755|SUPERIORITY||Mean Difference (Net)|-6.41|STANDARD_ERROR_OF_MEAN|2.86||0.026|TWO_SIDED|95.0|-12.04|-0.77|||Mixed Models Analysis|||||-0.77|-12.04|0.026
70946653|NCT03305809|141393755|SUPERIORITY||Mean Difference (Net)|-7.39|STANDARD_ERROR_OF_MEAN|2.969||0.014|TWO_SIDED|95.0|-13.24|-1.53|||Mixed Models Analysis|||||-1.53|-13.24|0.014
70946654|NCT03305809|141393755|SUPERIORITY||Mean Difference (Net)|-10.6|STANDARD_ERROR_OF_MEAN|3.104|<|0.001|TWO_SIDED|95.0|-16.72|-4.48|||Mixed Models Analysis|||||-4.48|-16.72|<0.001
70946655|NCT03305809|141393756|SUPERIORITY||Mean Difference (Net)|0.56|STANDARD_ERROR_OF_MEAN|1.362||0.683|TWO_SIDED|95.0|-2.13|3.24|||Mixed Models Analysis|||||3.24|-2.13|0.683
70946656|NCT03305809|141393756|SUPERIORITY||Mean Difference (Net)|2.41|STANDARD_ERROR_OF_MEAN|1.413||0.089|TWO_SIDED|95.0|-0.37|5.19|||Mixed Models Analysis|||||5.19|-0.37|0.089
70946657|NCT03305809|141393756|SUPERIORITY||Mean Difference (Net)|1.56|STANDARD_ERROR_OF_MEAN|1.489||0.294|TWO_SIDED|95.0|-1.37|4.49|||Mixed Models Analysis|||||4.49|-1.37|0.294
70946658|NCT03305809|141393757|SUPERIORITY||Mean Difference (Net)|0.63|STANDARD_ERROR_OF_MEAN|0.389||0.105|TWO_SIDED|95.0|-0.13|1.4|||Mixed Models Analysis|||||1.40|-0.13|0.105
70946659|NCT03305809|141393757|SUPERIORITY||Mean Difference (Net)|1.07|STANDARD_ERROR_OF_MEAN|0.406||0.009|TWO_SIDED|95.0|0.27|1.87|||Mixed Models Analysis|||||1.87|0.27|0.009
70946660|NCT03305809|141393757|SUPERIORITY||Mean Difference (Net)|0.49|STANDARD_ERROR_OF_MEAN|0.428||0.253|TWO_SIDED|95.0|-0.35|1.33|||Mixed Models Analysis|||||1.33|-0.35|0.253
71090710|NCT02858908|141687770|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-2.41||||0.0058|TWO_SIDED|95.0|-4.03|-0.8|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the caregiver top three concerns VAS total score (cm)||-0.80|-4.03|0.0058
70946661|NCT03305809|141393758|SUPERIORITY||Mean Difference (Net)|-1.74|STANDARD_ERROR_OF_MEAN|0.923||0.061|TWO_SIDED|95.0|-3.56|0.08|||Mixed Models Analysis|||Motor Experiences of Daily Living||0.08|-3.56|0.061
71090711|NCT02858908|141687770|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-1.95||||0.0208|TWO_SIDED|95.0|-3.56|-0.34|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the caregiver top three concerns VAS total score (cm)||-0.34|-3.56|0.0208
71090712|NCT02858908|141687771|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.054||||0.0068|TWO_SIDED|95.0|-0.092|-0.017|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the OSU Autism Rating Scale - DSM-IV (OARS-4) total impairment mean||-0.017|-0.092|0.0068
71090713|NCT02858908|141687771|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.009||||0.609|TWO_SIDED|95.0|-0.047|0.028|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the OSU Autism Rating Scale - DSM-IV (OARS-4) total impairment mean||0.028|-0.047|0.6090
71090714|NCT02858908|141687772|OTHER|A mixed effect model repeated measure (MMRM) was fitted to the observed values at week12 in OSU CGI-I. The model included dose group and visit as fixed effects, and the treatment-by-visit interaction. F-tests from PROC MIXED were based on Kenward-Roger's adjusted degrees of freedom. A compound symmetry covariance matrix was used for the repeated visits within subject.|Mean Difference (Net)|3.4||||0.0011|TWO_SIDED|95.0|3.0|3.7||p-values are presented for the comparison of adjusted Least Square Means to a score of 4, representing 'No change'|Mixed Models Analysis|||Observed value at week 12 in OSU global improvement scale for autism (OSU CGI-I)||3.7|3.0|0.0011
71090715|NCT02858908|141687772|OTHER|A mixed effect model repeated measure (MMRM) was fitted to the observed values at week12 in OSU CGI-I. The model included dose group and visit as fixed effects, and the treatment-by-visit interaction. F-tests from PROC MIXED were based on Kenward-Roger's adjusted degrees of freedom. A compound symmetry covariance matrix was used for the repeated visits within subject.|Mean Difference (Net)|4.0||||1|TWO_SIDED|95.0|3.6|4.4||p-values are presented for the comparison of adjusted Least Square Means to a score of 4, representing 'No change'|Mixed Models Analysis|||Observed value at week 12 in OSU global improvement scale for autism (OSU CGI-I)||4.4|3.6|1.0000
71090716|NCT02858908|141687773|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-5.91|||<|0.0001|TWO_SIDED|95.0|-8.35|-3.47|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline at week 12 in the clinician-completed domain specific causes for concern VAS total score (cm)||-3.47|-8.35|<0.0001
71090717|NCT02858908|141687773|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-3.27||||0.0116|TWO_SIDED|95.0|-5.71|-0.83|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline at week 12 in the clinician-completed domain specific causes for concern VAS total score (cm)||-0.83|-5.71|0.0116
70858351|NCT01933789|141202748|SUPERIORITY||probit regression coefficient|-0.121||||0.552|TWO_SIDED|95.0|-0.646|0.403||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.403|-0.646|0.552
70946662|NCT03305809|141393758|SUPERIORITY||Mean Difference (Net)|-2.37|STANDARD_ERROR_OF_MEAN|0.96||0.014|TWO_SIDED|95.0|-4.26|-0.47|||Mixed Models Analysis|||Motor Experiences of Daily Living||-0.47|-4.26|0.014
71090718|NCT02858908|141687774|OTHER|An ANCOVA was fitted to the change in the Peabody Picture Vocabulary Test age-based standard score from baseline to end of treatment. The model included the baseline value as a covariate and dose group as a fixed effect.|Mean Difference (Net)|-1.1||||0.6631|TWO_SIDED|95.0|-6.5|4.3|||ANCOVA||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the peabody picture vocabulary test age-based standard score||4.3|-6.5|0.6631
70946663|NCT03305809|141393758|SUPERIORITY||Mean Difference (Net)|-3.5|STANDARD_ERROR_OF_MEAN|1.013|<|0.001|TWO_SIDED|95.0|-5.5|-1.51|||Mixed Models Analysis|||Motor Experiences of Daily Living||-1.51|-5.50|<0.001
70946664|NCT03305809|141393758|SUPERIORITY||Mean Difference (Net)|-3.27|STANDARD_ERROR_OF_MEAN|1.822||0.074|TWO_SIDED|95.0|-6.86|0.32|||Mixed Models Analysis|||Motor Exam||0.32|-6.86|0.074
70946665|NCT03305809|141393758|SUPERIORITY||Mean Difference (Net)|-3.27|STANDARD_ERROR_OF_MEAN|1.891||0.085|TWO_SIDED|95.0|-7.0|0.45|||Mixed Models Analysis|||Motor Exam||0.45|-7.00|0.085
70946666|NCT03305809|141393758|SUPERIORITY||Mean Difference (Net)|-4.23|STANDARD_ERROR_OF_MEAN|1.959||0.032|TWO_SIDED|95.0|-8.09|-0.37|||Mixed Models Analysis|||Motor Exam||-0.37|-8.09|0.032
70946667|NCT03305809|141393760|SUPERIORITY||Mean Difference (Net)|0.3||||0.898|TWO_SIDED|95.0|-4.92|5.61|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||5.61|-4.92|0.898
71090719|NCT02858908|141687774|OTHER|An ANCOVA was fitted to the change in the Peabody Picture Vocabulary Test age-based standard score from baseline to end of treatment. The model included the baseline value as a covariate and dose group as a fixed effect.|Mean Difference (Net)|-0.1||||0.9546|TWO_SIDED|95.0|-5.5|5.2|||ANCOVA||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the peabody picture vocabulary test age-based standard score||5.2|-5.5|0.9546
71090720|NCT01773928|141687790|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The probability that the modified process is noninferior to the current one (i.e. lower limit of the 95% CI of the ratio of geometric means \[modified vs. current\] is greater than or equal to 0.67) is above 99% for one strain, and it is around 97% for all three strains (considering the three strains to be independent, 0.99 x 0.99 x 0.99=0.97)|ANCOVA|0.67|||||ONE_SIDED|95.0|0.67||||||||||0.67|
71090721|NCT01773928|141687792|SUPERIORITY_OR_OTHER_LEGACY||ANCOVA|0.67|||||TWO_SIDED|95.0|0.67|1.5||||||"The overall power to prove the similarity between the three lots for all three strains is approximately 99%.~For the two primary co-analyses (Noninferiority and Lot Consistency), the overall power of the immunogenicity analyses is approximately 96% (calculated as 0.97 x 0.99=0.96)."||1.5|0.67|
71090722|NCT01773928|141687793|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"Differences between fever incidences (95% CI) between treatment groups VCIV Modified (Total) and TIV was computed for each age cohort separately. The Confidence Interval estimation method was the method of Miettinen \& Nurminen, as described in the StatXact User Manual (i.e. the score statistics, also called Chan's method, page 283).~Noninferiority will be concluded if the upper limit of the 95% CI (VCIV modified-TIV) is \<5%."|Method of Miettinen & Nurminen|1.8||||||95.0|0.1|3.3||||||||3.3|0.1|
71127943|NCT04566601|141760768|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.18||||0.2833|TWO_SIDED|95.0|-0.52|0.15||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 125mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline CGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.15|-0.52|0.2833
71127944|NCT04566601|141760769|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.13||||0.4552|TWO_SIDED|95.0|-0.45|0.2||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 5mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.20|-0.45|0.4552
70946668|NCT03305809|141393760|SUPERIORITY||Mean Difference (Net)|0.6||||0.821|TWO_SIDED|95.0|-4.71|5.94|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||5.94|-4.71|0.821
70946669|NCT03305809|141393760|SUPERIORITY||Mean Difference (Net)|9.4|||<|0.001|TWO_SIDED|95.0|4.11|14.61|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||14.61|4.11|<0.001
70946670|NCT03305809|141393760|SUPERIORITY||Mean Difference (Net)|0.3||||0.805|TWO_SIDED|95.0|-2.4|3.08|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||3.08|-2.40|0.805
70946671|NCT03305809|141393760|SUPERIORITY||Mean Difference (Net)|0.9||||0.513|TWO_SIDED|95.0|-1.85|3.69|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||3.69|-1.85|0.513
70946672|NCT03305809|141393760|SUPERIORITY||Mean Difference (Net)|3.6||||0.011|TWO_SIDED|95.0|0.83|6.28|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||6.28|0.83|0.011
70946673|NCT03305809|141393761|SUPERIORITY||Mean Difference (Net)|2.5||||0.065|TWO_SIDED|95.0|-0.16|5.08|||Mixed Models Analysis|||||5.08|-0.16|0.065
70946674|NCT03305809|141393761|SUPERIORITY||Mean Difference (Net)|3.6||||0.008|TWO_SIDED|95.0|0.93|6.21|||Mixed Models Analysis|||||6.21|0.93|0.008
70946675|NCT03305809|141393761|SUPERIORITY||Mean Difference (Net)|8.7|||<|0.001|TWO_SIDED|95.0|6.06|11.27|||Mixed Models Analysis|||||11.27|6.06|<0.001
70946676|NCT03305809|141393762|SUPERIORITY||Mean Difference (Net)|1.6||||0.339|TWO_SIDED|95.0|-1.72|4.99|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||4.99|-1.72|0.339
71090723|NCT02431299|141687804|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Whether there were significant changes in the IMRS baseline scores to IMRS follow up scores.|t-test, 2 sided|t = 2.78, df = 182||||||<0.01
71090724|NCT02431299|141687805|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Regression, Linear|||Hypothesized that higher levels of IMR competence would predict higher IMRS outcomes.||||<0.05
71090725|NCT03573297|141687813|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.5745|TWO_SIDED|95.0|0.48|1.43||P-value is based on the log-rank test stratified by modified index episode (manic or depressive) and region (US, non-US).|Log Rank||Hazard ratio (Cariprazine 1.5 or 3.0 mg/day vs. Placebo) is based on Cox proportional hazards regression model, with treatment group as an explanatory variable, stratified by modified index episode (manic or depressive) and region (US, non-US).|||1.43|0.48|0.5745
71090726|NCT03573297|141687813|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.6308|TWO_SIDED|95.0|0.52|1.51||P-value is based on the log-rank test stratified by modified index episode (manic or depressive) and region (US, non-US).|Log Rank||Hazard ratio (Cariprazine 1.5 or 3.0 mg/day vs. Placebo) is based on Cox proportional hazards regression model, with treatment group as an explanatory variable, stratified by modified index episode (manic or depressive) and region (US, non-US).|||1.51|0.52|0.6308
71127945|NCT04566601|141760769|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.13||||0.4734|TWO_SIDED|95.0|-0.47|0.22||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 25mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.22|-0.47|0.4734
71127946|NCT04566601|141760769|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.03||||0.8388|TWO_SIDED|95.0|-0.36|0.29||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 75mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.29|-0.36|0.8388
71127947|NCT04566601|141760769|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.08||||0.554|TWO_SIDED|95.0|-0.35|0.19||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 125mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.19|-0.35|0.5540
71127948|NCT00183625|141760789|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED|95.0|||||Regression, Linear|||||||0.66
71127949|NCT00183625|141760790|SUPERIORITY_OR_OTHER|||||||0.0176||95.0||||The p-value listed is for the medication by time interaction.|Mixed Models Analysis|||Mixed effects regression of body mass index on medication group (risp or olanz), time (in days over first 18 months of study) and a group by time interaction with site and baseline timepoint indicators as covariates. The model included a random slope and intercept for time.||||.0176
71127950|NCT02473367|141760819|SUPERIORITY_OR_OTHER||Geom. least-squares mean ratio (GLSMR)|0.28|||||TWO_SIDED|90.0|0.24|0.32|||||Raltegravir+TUMS/Raltegravir only|||0.32|0.24|
71127951|NCT02473367|141760819|SUPERIORITY_OR_OTHER||GLSMR|0.86|||||TWO_SIDED|90.0|0.73|1.03|||||Raltegravir+12 Hrs Leader Antacid/Raltegravir only|||1.03|0.73|
71127952|NCT02473367|141760819|SUPERIORITY_OR_OTHER||GLSMR|0.9|||||TWO_SIDED|90.0|0.8|1.03|||||Raltegravir+12 Hrs TUMS/Raltegravir only|||1.03|0.80|
71127953|NCT02473367|141760820|SUPERIORITY_OR_OTHER||GLSMR|0.26|||||TWO_SIDED|90.0|0.21|0.32|||||Raltegravir+TUMS/Raltegravir only|||0.32|0.21|
71127954|NCT02473367|141760820|SUPERIORITY_OR_OTHER||GLSMR|0.86|||||TWO_SIDED|90.0|0.65|1.15|||||Raltegravir+12 Hrs Leader Antacid/Raltegravir only|||1.15|0.65|
71127955|NCT02473367|141760820|SUPERIORITY_OR_OTHER||GLSMR|0.98|||||TWO_SIDED|90.0|0.81|1.17|||||Raltegravir+12 Hrs TUMS/Raltegravir only|||1.17|0.81|
71127956|NCT02473367|141760821|SUPERIORITY_OR_OTHER||GLSMR|0.52|||||TWO_SIDED|90.0|0.45|0.61|||||Raltegravir+TUMS/Raltegravir only|||0.61|0.45|
71127957|NCT02473367|141760821|SUPERIORITY_OR_OTHER||GLSMR|0.42|||||TWO_SIDED|90.0|0.34|0.52|||||Raltegravir+12 Hrs Leader Antacid/Raltegravir only|||0.52|0.34|
71127958|NCT02473367|141760821|SUPERIORITY_OR_OTHER||GLSMR|0.43|||||TWO_SIDED|90.0|0.36|0.51|||||Raltegravir+12 Hrs TUMS/Raltegravir only|||0.51|0.36|
71127959|NCT02678923|141760822|SUPERIORITY||LS mean difference|0.73||||0.0738|TWO_SIDED|95.0|-0.07|1.52||Baseline parameter value as a covariate and treatment group as factor, adjusting for country and prior statin use.|ANCOVA|||||1.52|-0.07|0.0738
71127960|NCT04856904|141760900|SUPERIORITY||Bilateral difference|-3.2|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|-4.4|-2.0|||Student's t-test for paired samples|||||-2|-4.4|< 0.0001
71127961|NCT04856904|141760901|SUPERIORITY||Bilateral difference|0.0|STANDARD_ERROR_OF_MEAN|0.14|=|0.9476|TWO_SIDED|95.0|-0.3|0.3|||Student's t-test for paired samples|||Week 1: Trifarotene 50 mcg/g, vehicle cream||0.3|-0.3|= 0.9476
71127962|NCT04856904|141760901|SUPERIORITY||Bilateral difference|-0.6|STANDARD_ERROR_OF_MEAN|0.25|=|0.0248|TWO_SIDED|95.0|-1.1|-0.1|||Student's t-test for paired samples|||Week 2: Trifarotene 50 mcg/g, vehicle cream||-0.1|-1.1|= 0.0248
71127963|NCT04856904|141760901|SUPERIORITY||Bilateral difference|-0.8|STANDARD_ERROR_OF_MEAN|0.29|=|0.0072|TWO_SIDED|95.0|-1.4|-0.2|||Student's t-test for paired samples|||Week 4: Trifarotene 50 mcg/g, vehicle cream||-0.2|-1.4|= 0.0072
71127964|NCT04856904|141760901|SUPERIORITY||Bilateral difference|-1.4|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.1|-0.7|||Student's t-test for paired samples|||Week 8: Trifarotene 50 mcg/g, vehicle cream||-0.7|-2.1|< 0.0001
71127965|NCT04856904|141760901|SUPERIORITY||Bilateral difference|-2.1|STANDARD_ERROR_OF_MEAN|0.41|<|0.0001|TWO_SIDED|95.0|-2.9|-1.3|||Student's t-test for paired samples|||Week 12: Trifarotene 50 mcg/g, vehicle cream||-1.3|-2.9|< 0.0001
71127966|NCT04856904|141760901|SUPERIORITY||Bilateral difference|-2.7|STANDARD_ERROR_OF_MEAN|0.56|<|0.0001|TWO_SIDED|95.0|-3.8|-1.6|||Student's t-test for paired samples|||Week 16: Trifarotene 50 mcg/g, vehicle cream||-1.6|-3.8|< 0.0001
71127967|NCT04856904|141760901|SUPERIORITY||Bilateral difference|-2.5|STANDARD_ERROR_OF_MEAN|0.53|<|0.0001|TWO_SIDED|95.0|-3.5|-1.5|||Student's t-test for paired samples|||Week 20: Trifarotene 50 mcg/g, vehicle cream||-1.5|-3.5|< 0.0001
71127968|NCT00454181|141760965|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Chi-squared|||Chi-square analysis of the proportion of subjects in each group meeting the definition of positive response.||||0.30
71127969|NCT00454181|141760966|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Chi-squared|||Chi-square analysis of the proportion of subjects in each group meeting the definition of positive response||||0.26
70858352|NCT01933789|141202749|SUPERIORITY||probit regression coefficient|-0.293||||0.372|TWO_SIDED|95.0|-1.139|0.553||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.553|-1.139|0.372
70946677|NCT03305809|141393762|SUPERIORITY||Mean Difference (Net)|1.2||||0.486|TWO_SIDED|95.0|-2.26|4.73|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||4.73|-2.26|0.486
70858353|NCT01933789|141202750|SUPERIORITY||probit regression coefficient|-0.13||||0.501|TWO_SIDED|95.0|-0.63|0.369||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.369|-0.630|0.501
70858354|NCT01933789|141202751|SUPERIORITY||probit regression coefficient|-0.39||||0.192|TWO_SIDED|95.0|-1.16|0.38||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.380|-1.160|0.192
70858355|NCT01933789|141202752|SUPERIORITY||probit regression coefficient|-0.014||||0.94|TWO_SIDED|95.0|-0.489|0.461||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.461|-0.489|0.940
70858356|NCT01933789|141202753|SUPERIORITY||probit regression coefficient|-0.229||||0.47|TWO_SIDED|95.0|-1.044|0.587||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.587|-1.044|0.470
70858357|NCT01933789|141202754|SUPERIORITY||probit regression coefficient|-0.01||||0.955|TWO_SIDED|95.0|-0.474|0.454||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.454|-0.474|0.955
70858358|NCT01933789|141202755|SUPERIORITY||probit regression coefficient|-0.287||||0.303|TWO_SIDED|95.0|-1.005|0.431||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.431|-1.005|0.303
70858359|NCT00930982|141202761|SUPERIORITY_OR_OTHER||Difference in Least square means|-2.368|STANDARD_ERROR_OF_MEAN|2.674|<|0.001||||||p-value should be \< 0.023 (one-sided) for a significant result as an interim analysis was performed. Results based on the no-interaction model which was defined as primary analysis.|ANCOVA|Baseline cfu was covariate, treatment and pooled centers factors. As the p-value for interaction was 0.214, the no-interaction model is appropriate.|Least square mean Ciprofloxacin minus placebo|"Ho: CFU(EOT\|Cipro) - CFU(baseline\|Cipro) \> CFU(EOT\|Placebo) - CFU(baseline\|Placebo) CFU = colony forming units EOT=End of treatment (Day 29) Sample size was based a difference of 1.2 log10 CFU/g between placebo and Ciprofloxacin and a standard deviation of 2 log10 CFU/g"||||< 0.001
70858360|NCT03160859|141202808|SUPERIORITY|||||||0.62|||||||Chi-squared|||Chi Square||||0.62
70858361|NCT02522871|141202842|NON_INFERIORITY|non-inferiority margin = 0.075|Difference of Proportion|-0.132|||<|0.0001|ONE_SIDED|95.0||-0.049|||one-sided Farrington and Manning|||||-0.049||<0.0001
70858362|NCT02522871|141202842|NON_INFERIORITY|non-inferiority margin = 0.075|Difference of Proportion|-0.145|||<|0.0001|ONE_SIDED|95.0||-0.062|||one-sided Farrington and Manning|||||-0.062||<0.0001
70858363|NCT02522871|141202843|NON_INFERIORITY|non-inferiority margin of 1.0|Mean Difference (Final Values)|-0.03|||<|0.0001|TWO_SIDED|95.0|-0.084|0.025|||t-test, 1 sided|||||0.025|-0.084|<0.0001
70858364|NCT02522871|141202844|NON_INFERIORITY|non-inferiority margin = 0.075|Difference of Proportion|0.0||||0.0004|ONE_SIDED|95.0||0.036|||one-sided Farrington and Manning|||||0.036||0.0004
70858365|NCT02522871|141202844|NON_INFERIORITY|non-inferiority margin = 0.075|Difference of Proportion|0.0||||0.0004|ONE_SIDED|95.0||0.036|||one-sided Farrington and Manning|||||0.036||0.0004
71127970|NCT00454181|141760967|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Chi-squared|||"Chi-square analysis of the proportion of subjects in each group reporting change in oral warts from baseline to week 24 as better."||||0.50
71127971|NCT00454181|141760968|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Chi-squared|||"Chi-square analysis of the proportion of subjects in each group reporting change in global oral health from baseline to week 24 as better."||||0.29
70858366|NCT02522871|141202845|NON_INFERIORITY|non-inferiority margin = 0.075|Difference of Proportion|-0.001||||0.0006|ONE_SIDED|95.0||0.038|||one-sided Farrington and Manning|||||0.038||0.0006
70858367|NCT02522871|141202845|NON_INFERIORITY|non-inferiority margin = 0.075|Difference of Proportion|-0.001||||0.0006|ONE_SIDED|95.0||0.038|||one-sided Farrington and Manning|||||0.038||0.0006
70858368|NCT00509262|141202848|NON_INFERIORITY_OR_EQUIVALENCE|The pre-specified non-inferiority margin was 0.4%; i.e., non-inferiority required that the upper boundary of the 95% confidence interval for the treatment difference (sitagliptin minus glipizide) to be less than 0.4%.|Difference in least squares mean|-0.11|STANDARD_DEVIATION|0.74|||TWO_SIDED|95.0|-0.29|0.06|||ANCOVA||Based on analysis of covariance with terms for treatment, renal insufficiency stratum at Visit 4/Week -2 (moderate, or severe), prior diabetes pharmacotherapy (on or not on oral antihyperglycemic agent), and a covariate for baseline A1C.|||0.06|-0.29|
70858369|NCT00509262|141202849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8||||0.001|TWO_SIDED|95.0|-17.1|-4.8|||Miettirnen& Nurminen method||Miettirnen \& Nurminen method stratified by renal insufficiency stratum at Visit 4/Week -2 (moderate or severe) \& prior diabetes pharmacotherapy|||-4.8|-17.1|0.001
70858370|NCT00509262|141202850|SUPERIORITY_OR_OTHER||Difference in least squares mean|7.1|STANDARD_DEVIATION|38.3|||TWO_SIDED|95.0|-1.9|16.1|||ANCOVA||Analysis of covariance with terms for treatment, renal insufficiency stratum at Visit 4/Week -2 (moderate or severe), prior diabetes pharmacotherapy (on or not on oral antihyperglycemic agent), and a covariate for baseline Fasting Plasma Glucose.|||16.1|-1.9|
70858371|NCT00509262|141202851|SUPERIORITY_OR_OTHER||Difference in least squares mean|-1.8|STANDARD_DEVIATION|3.8|<|0.001|TWO_SIDED|95.0|-2.6|-1.0|||ANCOVA||Analysis of covariance with terms of treatment, renal insufficiency stratum at Visit 4/Week -2 (moderate or severe), prior diabetes pharmacotherapy (on or not on oral antihyperglycemic agent), and a covariate for baseline body weight.|||-1.0|-2.6|<0.001
70858372|NCT01150474|141202910|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||t-test, 2 sided|||||||0.82
70858373|NCT01150474|141202911|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||t-test, 2 sided|||||||0.75
70858374|NCT01150474|141202912|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||t-test, 2 sided|||||||0.07
70858375|NCT01150474|141202913|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||t-test, 2 sided|||||||0.43
71127972|NCT00454181|141760969|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||Chi-squared|||"Chi-square analysis of the proportion of subjects rated as improved with respect to changes in oral warts from baseline to week 24 by the attending investigator."||||0.74
71127973|NCT00454181|141760970|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Chi-squared|||"Chi-square analysis of the proportion of subjects rated as improved with resepect to changes from baseline to week 24 in global oral health by the attending investigator."||||.71
71127974|NCT03045341|141760973|SUPERIORITY|Analyses used all available data.||||||0.0001|||||||Mixed Models Analysis|Analyses to compare treatments were all intent-to-treat. Analyses were performed for all randomized patients who attended the first treatment session.||BWL versus no BWL||||0.0001
71127975|NCT03045341|141760973|SUPERIORITY|Analyses used all available data.||||||0.58|||||||Mixed Models Analysis|Analyses to compare treatments were all intent-to-treat. Analyses were performed for all randomized patients who attended the first treatment session.||NB versus placebo||||0.58
71127976|NCT03045341|141760974|SUPERIORITY|Analyses used all available data.||||||0.0001|||||||Mixed Models Analysis|Analyses to compare treatments were all intent-to-treat. Analyses were performed for all randomized patients who attended the first treatment session.||BWL versus no BWL||||0.0001
71127977|NCT03045341|141760974|SUPERIORITY|Analyses used all available data.||||||0.63|||||||Mixed Models Analysis|Analyses to compare treatments were all intent-to-treat. Analyses were performed for all randomized patients who attended the first treatment session.||NB versus placebo||||0.63
71127978|NCT03045341|141760975|SUPERIORITY|||||||0.004|||||||Chi-squared|||Analyses used all available data.||||.004
71127979|NCT01727336|141760990|OTHER||recommended dose for Part 2|0.9|||||TWO_SIDED||||||||The recommended dose level for Part 2 was determined to be 0.9 mg/kg|||||
71127980|NCT02772978|141761021|SUPERIORITY|||||||0.04||||||The threshold for statistical significance was set to p \< 0.05.|Fisher transformation|||The comparison group represents the difference in ICR and the baseline impulsiveness scale, non-planning subscale.||||0.04
71127981|NCT02772978|141761022|SUPERIORITY||||||<|0.05||||||The threshold is set to p \< 0.05, corrected for multiple comparisons.|Fisher transformation|||||||< 0.05
71127982|NCT01532869|141761024|SUPERIORITY_OR_OTHER||Difference in Least Square (LS) mean|-2.7||||0.0915|TWO_SIDED|95.0|-5.85|0.45|||Mixed Models Analysis|||The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||0.45|-5.85|0.0915
71127983|NCT01532869|141761026|SUPERIORITY_OR_OTHER||Difference in LS mean|-0.43||||0.9336|TWO_SIDED|95.0|-10.78|9.91|||Mixed Models Analysis|||Change From Baseline in Intestinal VAS Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||9.91|-10.78|0.9336
71127984|NCT01532869|141761026|SUPERIORITY_OR_OTHER||Difference in LS mean|-4.12||||0.4609|TWO_SIDED|95.0|-15.21|6.96|||Mixed Models Analysis|||Change From Baseline in Breathing VAS Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||6.96|-15.21|0.4609
71127985|NCT01532869|141761026|SUPERIORITY_OR_OTHER||Difference in LS mean|-1.28||||0.8493|TWO_SIDED|95.0|-14.7|12.13|||Mixed Models Analysis|||Change From Baseline in Raynaud Syndrome Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||12.13|-14.70|0.8493
71127986|NCT01532869|141761026|SUPERIORITY_OR_OTHER||Difference in LS mean|4.89||||0.4717|TWO_SIDED|95.0|-8.59|18.37|||Mixed Models Analysis|||Change From Baseline in Finger Ulcers Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||18.37|-8.59|0.4717
71127987|NCT01532869|141761026|SUPERIORITY_OR_OTHER||Difference in LS mean|-0.08||||0.9876|TWO_SIDED|95.0|-9.93|9.78|||Mixed Models Analysis|||Change From Baseline in Overall Disease Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||9.78|-9.93|0.9876
71127988|NCT01532869|141761026|SUPERIORITY_OR_OTHER||Difference in LS mean|-6.8||||0.2407|TWO_SIDED|95.0|-18.3|4.71|||Mixed Models Analysis|||Change From Baseline in Intestinal VAS Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||4.71|-18.30|0.2407
71127989|NCT01532869|141761026|SUPERIORITY_OR_OTHER||Difference in LS mean|1.54||||0.7742|TWO_SIDED|95.0|-9.18|12.26|||Mixed Models Analysis|||Change From Baseline in Breathing VAS Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||12.26|-9.18|0.7742
71127990|NCT01532869|141761026|SUPERIORITY_OR_OTHER||Difference in LS mean|-4.48||||0.5182|TWO_SIDED|95.0|-18.28|9.31|||Mixed Models Analysis|||Change From Baseline in Raynaud Syndrome Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||9.31|-18.28|0.5182
70946678|NCT03305809|141393762|SUPERIORITY||Mean Difference (Net)|4.2||||0.024|TWO_SIDED|95.0|0.56|7.81|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||7.81|0.56|0.024
70946679|NCT03305809|141393762|SUPERIORITY||Mean Difference (Net)|-0.1||||0.935|TWO_SIDED|95.0|-2.04|1.88|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||1.88|-2.04|0.935
70946680|NCT03305809|141393762|SUPERIORITY||Mean Difference (Net)|0.7||||0.505|TWO_SIDED|95.0|-1.34|2.72|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||2.72|-1.34|0.505
71127991|NCT01532869|141761026|SUPERIORITY_OR_OTHER||Difference in LS mean|-5.8||||0.3106|TWO_SIDED|95.0|-17.2|5.59|||Mixed Models Analysis|||Change From Baseline in Finger Ulcers Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||5.59|-17.20|0.3106
71127992|NCT01532869|141761026|SUPERIORITY_OR_OTHER||Difference in LS mean|-7.82||||0.1717|TWO_SIDED|95.0|-19.11|3.48|||Mixed Models Analysis|||Change From Baseline in Overall Disease Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||3.48|-19.11|0.1717
71127993|NCT01532869|141761027|SUPERIORITY_OR_OTHER||Difference in LS mean|0.02||||0.8503|TWO_SIDED|95.0|-0.186|0.225|||Mixed Models Analysis|||Change From Baseline in HAQ-DI Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction||0.225|-0.186|0.8503
71127994|NCT01532869|141761027|SUPERIORITY_OR_OTHER||Difference in LS mean|-0.207||||0.1212|TWO_SIDED|95.0|-0.471|0.056|||Mixed Models Analysis|||Change From Baseline in HAQ-DI Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||0.056|-0.471|0.1212
71127995|NCT01532869|141761028|SUPERIORITY_OR_OTHER||Difference in LS mean|-0.99||||0.8118|TWO_SIDED|95.0|-9.2|7.23|||Mixed Models Analysis|||Change From Baseline in Clinician's Global Assessment at Week 24.The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||7.23|-9.20|0.8118
71127996|NCT01532869|141761028|SUPERIORITY_OR_OTHER||Difference in LS mean|-9.02||||0.0768|TWO_SIDED|95.0|-19.04|1.0|||Mixed Models Analysis|||Change From Baseline in Clinician's Global Assessment at Week 48.The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||1.00|-19.04|0.0768
71127997|NCT01532869|141761029|SUPERIORITY_OR_OTHER||Difference in LS mean|-3.85||||0.4063|TWO_SIDED|95.0|-13.04|5.34|||Mixed Models Analysis|||Change From Baseline in Patient's Global Assessment at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||5.34|-13.04|0.4063
71127998|NCT01532869|141761029|SUPERIORITY_OR_OTHER||Difference in LS mean|-8.3||||0.1371|TWO_SIDED|95.0|-19.31|2.71|||Mixed Models Analysis|||Change From Baseline in Patient's Global Assessment at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||2.71|-19.31|0.1371
71127999|NCT01532869|141761030|SUPERIORITY_OR_OTHER||Difference in LS mean|1.43||||0.5197|TWO_SIDED|95.0|-2.97|5.82|||Mixed Models Analysis|||Change From Baseline in FACIT-Fatigue Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||5.82|-2.97|0.5197
71128000|NCT01532869|141761030|SUPERIORITY_OR_OTHER||Difference in LS mean|2.75||||0.1886|TWO_SIDED|95.0|-1.38|6.88|||Mixed Models Analysis|||Change From Baseline in FACIT-Fatigue Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||6.88|-1.38|0.1886
71128001|NCT01532869|141761031|SUPERIORITY_OR_OTHER||Difference in LS mean|0.79||||0.3651|TWO_SIDED|95.0|-0.94|2.51|||Mixed Models Analysis|||Change From Baseline in 5-D Itch Scale at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||2.51|-0.94|0.3651
71128002|NCT01532869|141761031|SUPERIORITY_OR_OTHER||Difference in LS mean|-1.11||||0.2841|TWO_SIDED|95.0|-3.16|0.94|||Mixed Models Analysis|||Change From Baseline in 5-D Itch Scale at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||0.94|-3.16|0.2841
70946681|NCT03305809|141393762|SUPERIORITY||Mean Difference (Net)|1.22||||0.266|TWO_SIDED|95.0|-0.91|3.3|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||3.30|-0.91|0.266
71128003|NCT01532869|141761032|SUPERIORITY_OR_OTHER||Difference in LS mean|-3.55||||0.0579|TWO_SIDED|95.0|-7.23|0.12|||Mixed Models Analysis|||The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||0.12|-7.23|0.0579
70858376|NCT01150474|141202914|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||||||0.30
70946682|NCT03305809|141393763|SUPERIORITY||Mean Difference (Net)|0.6||||0.55|TWO_SIDED|95.0|-1.28|2.41|||Mixed Models Analysis|||||2.41|-1.28|0.550
70946683|NCT03305809|141393763|SUPERIORITY||Mean Difference (Net)|1.8||||0.069|TWO_SIDED|95.0|-0.14|3.68|||Mixed Models Analysis|||||3.68|-0.14|0.069
70946684|NCT03305809|141393763|SUPERIORITY||Mean Difference (Net)|2.9||||0.005|TWO_SIDED|95.0|0.89|4.83|||Mixed Models Analysis|||||4.83|0.89|0.005
70946685|NCT03305809|141393764|SUPERIORITY||Mean Difference (Net)|-7.0||||0.045|TWO_SIDED|95.0|-13.92|-0.15|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||-0.15|-13.92|0.045
71128004|NCT01532869|141761033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39|STANDARD_ERROR_OF_MEAN|0.704||0.2159|TWO_SIDED|95.0|0.6|9.5|||Regression, Logistic|||The logistic regression model included the fixed categorical effects of treatment and the stratification factor of joint involvement at the baseline visit. The continuous covariate of baseline mRSS score was also included in the model.||9.50|0.60|0.2159
71128005|NCT01424228|141761073|SUPERIORITY_OR_OTHER_LEGACY|||||||0.367|||||||Cochran-Mantel-Haenszel|||||||0.367
71128006|NCT00422383|141761196|SUPERIORITY_OR_OTHER||Weighted Difference|-0.01||||0.8156|TWO_SIDED|95.0|-0.13|0.1|||Cochran-Mantel-Haenszel||Analysis stratified by region, prior biologic use, rheumatoid factor (RF) status, and treatment.|||0.10|-0.13|0.8156
71128007|NCT00422383|141761196|SUPERIORITY_OR_OTHER||Weighted Difference|0.07||||0.2419|TWO_SIDED|95.0|-0.05|0.19|||Cochran-Mantel-Haenszel||Analysis stratified by region, prior biologic use, RF status, and treatment.|||0.19|-0.05|0.2419
71128008|NCT00422383|141761199|SUPERIORITY_OR_OTHER|||||||0.7127|TWO_SIDED|||||Stratified by region, prior biologic use, RF status and treatment.|ANOVA|||||||0.7127
71128009|NCT00422383|141761199|SUPERIORITY_OR_OTHER|||||||0.1018|TWO_SIDED|||||Stratified by region, prior biologic use, RF status and treatment.|ANOVA|||||||0.1018
71128010|NCT00422383|141761200|SUPERIORITY_OR_OTHER|||||||0.5029|TWO_SIDED|||||Stratified by region, prior biologic use, RF status, and treatment.|Cochran-Mantel-Haenszel|||||||0.5029
71128011|NCT00422383|141761200|SUPERIORITY_OR_OTHER|||||||0.0495|TWO_SIDED|||||Stratified by region, prior biologic use, RF status, and treatment.|Cochran-Mantel-Haenszel|||||||0.0495
71128012|NCT03738618|141761237|OTHER||Treatment difference|43.3|||<|0.001|TWO_SIDED|95.0|36.5|47.6|||Fisher Exact||95% exact Agresti-Min confidence intervals.|||47.6|36.5|<0.001
71128013|NCT03738618|141761238|OTHER||Treatment difference|22.0|||<|0.001|TWO_SIDED|95.0|14.9|25.7|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Ongoing Pregnancy Rate in the Fresh Cycle||25.7|14.9|<0.001
71128014|NCT03738618|141761242|OTHER||Treatment difference|26.8|||<|0.001|TWO_SIDED|95.0|19.8|30.8|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Clinical pregnancy rate in the fresh cycle||30.8|19.8|<0.001
70946686|NCT03305809|141393764|SUPERIORITY||Mean Difference (Net)|3.1||||0.39|TWO_SIDED|95.0|-4.05|10.32|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||10.32|-4.05|0.390
70946687|NCT03305809|141393764|SUPERIORITY||Mean Difference (Net)|-1.1||||0.768|TWO_SIDED|95.0|-8.32|6.16|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||6.16|-8.32|0.768
70946688|NCT03305809|141393764|SUPERIORITY||Mean Difference (Net)|-4.3||||0.041|TWO_SIDED|95.0|-8.48|-0.17|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||-0.17|-8.48|0.041
70946689|NCT03305809|141393764|SUPERIORITY||Mean Difference (Net)|-0.5||||0.802|TWO_SIDED|95.0|-4.81|3.72|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||3.72|-4.81|0.802
71128015|NCT03738618|141761242|OTHER||Treatment difference|52.0|||<|0.001|TWO_SIDED|95.0|44.9|56.3|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Clinical pregnancy rate cumulatively||56.3|44.9|<0.001
71128016|NCT03738618|141761243|OTHER||Treatment difference|23.5|||<|0.001|TWO_SIDED|95.0|16.7|27.2|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Vital pregnancy rate in the fresh cycle||27.2|16.7|<0.001
71128017|NCT03738618|141761243|OTHER||Treatment difference|45.6|||<|0.001|TWO_SIDED|95.0|38.5|49.9|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Vital pregnancy rate cumulatively||49.9|38.5|<0.001
71128018|NCT03738618|141761245|OTHER||Treatment difference|32.1|||<|0.001|TWO_SIDED|95.0|24.9|36.2|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Positive βhCG rate in the fresh cycle||36.2|24.9|<0.001
70946690|NCT03305809|141393764|SUPERIORITY||Mean Difference (Net)|-2.4||||0.284|TWO_SIDED|95.0|-6.67|1.97|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||1.97|-6.67|0.284
70946691|NCT03305809|141393765|SUPERIORITY||Mean Difference (Net)|0.0||||0.996|TWO_SIDED|95.0|-4.17|4.19|||Mixed Models Analysis|||||4.19|-4.17|0.996
71128019|NCT03738618|141761245|OTHER||Treatment difference|58.9|||<|0.001|TWO_SIDED|95.0|51.9|63.0|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Positive βhCG rate cumulatively||63.0|51.9|<0.001
71128020|NCT03738618|141761257|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
71128021|NCT03738618|141761258|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
71128022|NCT03738618|141761259|OTHER|||||||0.19|||||||Fisher Exact|||||||0.190
71128023|NCT03738618|141761260|OTHER|||||||0.396|||||||Fisher Exact|||||||0.396
71128024|NCT00649428|141761306|SUPERIORITY_OR_OTHER|||||||1e-05|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Stratified by combined treatment site.||A 5% level of significance was used as the threshold for determination of statistical significance, and all tests were two-tailed. the effect size and associated 95% confidence interval (CI) are provided for all comparative efficacy outcomes. Primary analysis of the two co-primary efficacy endpoints and the secondary efficacy endpoints were performed on the ITT population.||||.00001
71128025|NCT00649428|141761309|SUPERIORITY_OR_OTHER||||||<|1e-05|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Stratified by combined treatment site.||A 5% level of significance was used as the threshold for determination of statistical significance, and all tests were two-tailed. the effect size and associated 95% confidence interval (CI) are provided for all comparative efficacy outcomes. Primary analysis of the two co-primary efficacy endpoints and the secondary efficacy endpoints were performed on the ITT population.||||<.00001
71128026|NCT02277925|141761313|SUPERIORITY||Risk Ratio (RR)|1.74||||0.3|TWO_SIDED|95.0|0.59|5.14|||Chi-squared|||||5.14|0.59|0.30
71128027|NCT02277925|141761314|SUPERIORITY||Risk Ratio (RR)|1.03||||0.43|TWO_SIDED|95.0|0.96|1.11|||Chi-squared|||||1.11|0.96|0.43
71128028|NCT02277925|141761315|SUPERIORITY||Mean Difference (Final Values)|-4.5||||0.39|TWO_SIDED|95.0|-14.7|5.7|||t-test, 2 sided|||||5.7|-14.7|0.39
70858377|NCT01150474|141202915|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||t-test, 2 sided|||||||0.14
70858378|NCT01150474|141202916|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||t-test, 2 sided|||||||0.83
70858379|NCT01150474|141202917|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||t-test, 2 sided|||||||0.55
70858380|NCT01150474|141202918|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||t-test, 2 sided|||||||0.59
70858381|NCT02290431|141202919|SUPERIORITY||||||<|0.0001|||||||single-sample binomial test|||||||< 0.0001
70858382|NCT01007253|141202954|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Friedman ANOVA|||Analysis of variance (ANOVA) was used to test the null hypothesis of no mean eye symptoms score difference among the four treatment groups.||||<0.001
70858383|NCT01007253|141202955|SUPERIORITY_OR_OTHER|||||||0.05|||||||Friedman ANOVA|||Analysis of variance (ANOVA) was used to test the null hypothesis of no mean nasal symptoms score difference among the four treatment groups.||||0.05
70858384|NCT01007253|141202956|SUPERIORITY_OR_OTHER|||||||0.001|||||||Friedman ANOVA|||Analysis of variance (ANOVA) was used to test the null hypothesis of no mean sneeze difference among the four treatment groups.||||0.001
70858385|NCT01007253|141202957|SUPERIORITY_OR_OTHER|||||||0.11|||||||Friedman ANOVA|||Analysis of variance (ANOVA) was used to test the null hypothesis of no mean histamine level difference among the four treatment groups.||||0.11
70946692|NCT03305809|141393765|SUPERIORITY||Mean Difference (Net)|-0.7||||0.767|TWO_SIDED|95.0|-4.99|3.69|||Mixed Models Analysis|||||3.69|-4.99|0.767
71128029|NCT01272635|141761316|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.04|TWO_SIDED|95.0|0.41|0.98|||Discrete time survival analysis||Hazard ratio: Numerator is Azithromycin and Denominator is Placebo|||0.98|0.41|0.04
71128030|NCT04783077|141761333|SUPERIORITY||Odds Ratio (OR)|2.28||||0.23|TWO_SIDED|95.0|0.61|8.5|||Regression, Logistic||The estimated odds ratio of return donation attempt represents WhatsApp compared to control.|The primary analysis applies only to the RCT participants (N=130). Docudrama participants were not assessed for return blood donation. Analysis used fitted logistic regression with outcome donation attempted (Y/N) on the modiﬁed intention-to-treat (mITT) population, adjusted for type of donor (FRD, VNRBD).|Missing data on the primary outcome from the mITT analysis was handled using multiple imputation via chained equations with 50 imputations, and included stratum, group assignment (WhatsApp, Control) and ethnicity. Ethnicity was the only baseline variable with a minimum Kendall's tau of 0.2 with donation attempt.|8.50|0.61|0.23
71128031|NCT00849862|141761342|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|92.2||||||90.0|85.0|100.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100|85.0|
70946693|NCT03305809|141393765|SUPERIORITY||Mean Difference (Net)|-0.6||||0.791|TWO_SIDED|95.0|-4.96|3.79|||Mixed Models Analysis|||||3.79|-4.96|0.791
71128032|NCT00849862|141761343|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|100.0||||||90.0|96.3|104.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104|96.3|
71128033|NCT00849862|141761344|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|99.6||||||90.0|96.2|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|96.2|
71128034|NCT02540993|141761363|SUPERIORITY||Hazard Ratio (HR)|0.825|||=|0.0014|TWO_SIDED|95.0|0.732|0.928||P-value from stratified log-rank test. Significance was considered to be achieved if p-value ≤ 0.03282695.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||0.928|0.732|= 0.0014
71128035|NCT02540993|141761364|SUPERIORITY||Hazard Ratio (HR)|0.86|||=|0.0339|TWO_SIDED|95.0|0.747|0.989||P-value from stratified log-rank test. Significance was considered to be achieved if p-value ≤ 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||0.989|0.747|= 0.0339
71128036|NCT02540993|141761365|SUPERIORITY|If treatment effect on both primary and key secondary endpoint is significant, other secondary efficacy endpoints (i.e. all-cause mortality, all-cause hospitalization, change in UACR from baseline to Month 4, and secondary renal composite endpoint) will be tested hierarchically, starting with all-cause mortality. If treatment effect on all-cause mortality was not significant, all other endpoints would be tested in an exploratory manner.|Hazard Ratio (HR)|0.895|||=|0.2348|TWO_SIDED|95.0|0.746|1.075||P-value from stratified log-rank test. Significance was considered to be achieved if p-value ≤ 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||1.075|0.746|= 0.2348
71128037|NCT02540993|141761366|SUPERIORITY|If treatment effect on both primary and key secondary endpoint is significant, other secondary efficacy endpoints (i.e. all-cause mortality, all-cause hospitalization, change in UACR from baseline to Month 4, and secondary renal composite endpoint) will be tested hierarchically, starting with all-cause mortality. If treatment effect on all-cause mortality was not significant, all other endpoints would be tested in an exploratory manner.|Hazard Ratio (HR)|0.946|||=|0.1623|TWO_SIDED|95.0|0.876|1.022||P-value from stratified log-rank test.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||1.022|0.876|= 0.1623
71128038|NCT02540993|141761367|SUPERIORITY|If treatment effect on both primary and key secondary endpoint is significant, other secondary efficacy endpoints (i.e. all-cause mortality, all-cause hospitalization, change in UACR from baseline to Month 4, and secondary renal composite endpoint) will be tested hierarchically, starting with all-cause mortality. If treatment effect on all-cause mortality was not significant, all other endpoints would be tested in an exploratory manner.|Ratio of least squares means|0.688|||<|0.0001|TWO_SIDED|95.0|0.662|0.715||P-value from F-test of equal means between the treatment groups.|ANCOVA|||||0.715|0.662|< 0.0001
70946694|NCT03305809|141393766|SUPERIORITY||Mean Difference (Net)|0.98||||0.312|TWO_SIDED|95.0|-0.93|2.88|||ANCOVA|||Week 12||2.88|-0.93|0.312
71128039|NCT02540993|141761368|SUPERIORITY|If treatment effect on both primary and key secondary endpoint is significant, other secondary efficacy endpoints (i.e. all-cause mortality, all-cause hospitalization, change in UACR from baseline to Month 4, and secondary renal composite endpoint) will be tested hierarchically, starting with all-cause mortality. If treatment effect on all-cause mortality was not significant, all other endpoints would be tested in an exploratory manner.|Hazard Ratio (HR)|0.763|||=|0.0012|TWO_SIDED|95.0|0.648|0.9||P-value from stratified log-rank test.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||0.900|0.648|= 0.0012
71128040|NCT01009086|141761377|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71128041|NCT01009086|141761377|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71128042|NCT01009086|141761377|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71128043|NCT01009086|141761378|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71128044|NCT01009086|141761378|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71128045|NCT01009086|141761378|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71128046|NCT01009086|141761379|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71128047|NCT01009086|141761379|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71128048|NCT01009086|141761379|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
70858386|NCT01007253|141202958|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Friedman ANOVA|||Analysis of variance (ANOVA) was used to test the null hypothesis of no mean tryptase level difference among the four treatment groups.||||<0.001
70858387|NCT00814801|141202960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.49||||0.0113|TWO_SIDED|95.0|-2.64|-0.34|||Least Square Means|||||-0.34|-2.64|0.0113
70946695|NCT03305809|141393766|SUPERIORITY||Mean Difference (Net)|1.03||||0.289|TWO_SIDED|95.0|-0.89|2.95|||ANCOVA|||Week 12||2.95|-0.89|0.289
71128049|NCT01009086|141761380|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71128050|NCT01009086|141761380|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71128051|NCT01009086|141761380|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71128052|NCT01009086|141761381|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71128053|NCT01009086|141761381|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71128054|NCT01009086|141761381|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71128055|NCT01009086|141761382|SUPERIORITY_OR_OTHER|||||||0.017|||||||re-randomization test|||||||0.017
71128056|NCT01009086|141761382|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71128057|NCT01009086|141761382|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71128058|NCT01192828|141761392|OTHER|Descriptive analysis||||||0.235|||||||t-test, 2 sided|paired||Null hypothesis applied.||||0.235
71128059|NCT01192828|141761393|OTHER|Descriptive analysis.||||||0.701|||||||t-test, 2 sided|paired||Null hypothesis assumed.||||0.701
71128060|NCT01192828|141761394|OTHER|Descriptive analysis.||||||0.19|||||||t-test, 2 sided|paired t-test||Null hypothesis applied.||||0.190
71128061|NCT01192828|141761395|OTHER|Descriptive analysis.||||||0.052|||||||t-test, 2 sided|paired t-test||Null hypothesis applied.||||0.052
71128062|NCT01192828|141761396|OTHER|Descriptive analysis.||||||0.014|||||||t-test, 2 sided|paired t-test||Null hypothesis assumed.||||0.014
71128063|NCT01192828|141761398|OTHER|Descriptive analysis||||||0.541|||||||Spearman's rank correlation|||Null hypothesis assumed|Spearman's rank correlation rho is 0.179, with p value 0.541, N is 14|||.541
71128064|NCT01192828|141761400|OTHER|Descriptive analysis||||||0.014|||||||t-test, 2 sided|paired t-test||Null hypothesis assumed||||0.014
71128065|NCT01192828|141761401|OTHER|Descriptive analysis||||||0.012|||||||t-test, 2 sided|paired t-test||Null hypothesis assumed||||0.012
71128066|NCT01192828|141761402|OTHER|Descriptive analysis.||||||0.16|||||||t-test, 2 sided|paired t-test||Null hypothesis applied.||||0.160
71128067|NCT01192828|141761403|OTHER|Descriptive analysis||||||0.1|||||||t-test, 2 sided|||||||0.10
71128068|NCT00820222|141761404|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.36|TWO_SIDED|95.0|0.26|1.63|||Odds Ratio||The Odds Ratio is based on a logistic regression model. The P-value for the test of Odds Ratio is 1.|||1.63|0.26|0.360
71128069|NCT00820222|141761405|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.021|TWO_SIDED|95.0|1.04|1.64|||Log Rank||A HR \> 1 indicates a higher risk for lapatinib+capecitabine compared with trastuzumab+capecitabine.|||1.64|1.04|0.021
71128070|NCT00820222|141761407|SUPERIORITY||Hazard Ratio (HR)|1.34||||0.095|TWO_SIDED|95.0|0.95|1.9|||Log Rank||A HR \> 1 indicates a higher risk for lapatinib+capecitabine compared with trastuzumab+capecitabine.|||1.90|0.95|0.095
71128071|NCT00820222|141761408|SUPERIORITY||Odds Ratio (OR)|0.7984||||0.2731|TWO_SIDED|95.0|0.5407|1.1771|||Fisher Exact|||Comparison for Overall Response (CR+PR)||1.1771|0.5407|0.2731
71128072|NCT00820222|141761409|SUPERIORITY||Odds Ratio (OR)|0.9016||||0.6106|TWO_SIDED|95.0|0.6315|1.2866|||Fisher Exact|||Comparison for Clinical Benefit||1.2866|0.6315|0.6106
71128073|NCT00590577|141761415|SUPERIORITY_OR_OTHER||Difference in least-squares means|-9.8|STANDARD_ERROR_OF_MEAN|2.0|<|0.001||95.0|-13.71|-5.85||Used analysis of covariance model with treatment (placebo, paliperidone palmitate 25, 100, 150 mg eq.) and country as factors and baseline value as a covariate. P-values adjusted for multiplicity for comparison with placebo using Dunnett's test.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|The overall type I error rate for testing all paliperidone palmitate doses vs. placebo for both the primary outcome and key secondary outcome was controlled at the 2-sided 0.05 significance level. The 2 families of hypotheses (in each family, comparison of each paliperidone palmitate dose vs. placebo) were tested using a parallel gatekeeping procedure that adjusts for multiplicity by using Dunnett's method in each family of hypotheses and using Bonferroni's inequality between different families.||-5.85|-13.71|<0.001
71128074|NCT00590577|141761415|SUPERIORITY_OR_OTHER||Difference in least-squares means|-8.7|STANDARD_ERROR_OF_MEAN|2.0|<|0.001||95.0|-12.62|-4.78||Used analysis of covariance model with treatment (placebo, paliperidone palmitate 25, 100, 150 mg eq.) and country as factors and baseline value as a covariate. P-values adjusted for multiplicity for comparison with placebo using Dunnett's test.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|The overall type I error rate for testing all paliperidone palmitate doses vs. placebo for both the primary outcome and key secondary outcome was controlled at the 2-sided 0.05 significance level. The 2 families of hypotheses (in each family, comparison of each paliperidone palmitate dose vs. placebo) were tested using a parallel gatekeeping procedure that adjusts for multiplicity by using Dunnett's method in each family of hypotheses and using Bonferroni's inequality between different families.||-4.78|-12.62|<0.001
71128075|NCT00590577|141761415|SUPERIORITY_OR_OTHER||Difference in least-squares means|-5.1|STANDARD_ERROR_OF_MEAN|2.01||0.034||95.0|-9.01|-1.1||Used analysis of covariance model with treatment (placebo, paliperidone palmitate 25, 100, 150 mg eq.) and country as factors and baseline value as a covariate. P-values adjusted for multiplicity for comparison with placebo using Dunnett's test.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|The overall type I error rate for testing all paliperidone palmitate doses vs. placebo for both the primary outcome and key secondary outcome was controlled at the 2-sided 0.05 significance level. The 2 families of hypotheses (in each family, comparison of each paliperidone palmitate dose vs. placebo) were tested using a parallel gatekeeping procedure that adjusts for multiplicity by using Dunnett's method in each family of hypotheses and using Bonferroni's inequality between different families.||-1.10|-9.01|0.034
71128076|NCT00590577|141761416|SUPERIORITY_OR_OTHER||Difference in least-squares means|6.2|STANDARD_ERROR_OF_MEAN|1.49|<|0.001||95.0|3.26|9.12||P-values were adjusted for multiplicity between PANSS total score (primary efficacy endpoint) and PSP, as well as different dose levels in comparison with placebo, using the Dunnett-Bonferroni-based parallel gatekeeping method.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|Analysis of the key secondary endpoint was conducted using an analysis of covariance model with treatment and country as factors, and the baseline PSP score as a covariate. The Dunnett-Bonferroni-based parallel gatekeeping approach was used to adjust for multiple testing.||9.12|3.26|<0.001
71128077|NCT00590577|141761416|SUPERIORITY_OR_OTHER||Difference in least-squares means|4.4|STANDARD_ERROR_OF_MEAN|1.5||0.007||95.0|1.43|7.31||P-values were adjusted for multiplicity between PANSS total score (primary efficacy endpoint) and PSP, as well as different dose levels in comparison with placebo, using the Dunnett-Bonferroni-based parallel gatekeeping method.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|Analysis of the key secondary endpoint was conducted using an analysis of covariance model with treatment and country as factors, and the baseline PSP score as a covariate. The Dunnett-Bonferroni-based parallel gatekeeping approach was used to adjust for multiple testing.||7.31|1.43|0.007
71128078|NCT00590577|141761416|SUPERIORITY_OR_OTHER||Difference in least-squares means|1.0|STANDARD_ERROR_OF_MEAN|1.5||0.509||95.0|-1.96|3.95||P-values were adjusted for multiplicity between PANSS total score (primary efficacy endpoint) and PSP, as well as different dose levels in comparison with placebo, using the Dunnett-Bonferroni-based parallel gatekeeping method.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|Analysis of the key secondary endpoint was conducted using an analysis of covariance model with treatment and country as factors, and the baseline PSP score as a covariate. The Dunnett-Bonferroni-based parallel gatekeeping approach was used to adjust for multiple testing.||3.95|-1.96|0.509
71128079|NCT00590577|141761417|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparisons with placebo were without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment and country as factors, and (non-ranked) baseline CGI-S score as a covariate.||||<0.001
71128080|NCT00590577|141761417|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Comparisons with placebo were without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment and country as factors, and (non-ranked) baseline CGI-S score as a covariate.||||0.005
70858388|NCT00814801|141202960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.59|||<|0.0001|TWO_SIDED|95.0|-3.74|-1.44|||Least Square Means|||||-1.44|-3.74|<0.0001
70946696|NCT03305809|141393766|SUPERIORITY||Mean Difference (Net)|1.56||||0.141|TWO_SIDED|95.0|-0.53|3.65|||ANCOVA|||Week 12||3.65|-0.53|0.141
71128081|NCT00590577|141761417|SUPERIORITY_OR_OTHER|||||||0.14||95.0||||Comparisons with placebo were without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment and country as factors, and (non-ranked) baseline CGI-S score as a covariate.||||0.140
71128082|NCT01229449|141761418|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71128083|NCT01229449|141761418|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71128084|NCT01229449|141761418|SUPERIORITY|||||||0.0001|||||||ANOVA|||||||0.0001
70858389|NCT00814801|141202962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.0774|TWO_SIDED|95.0|-0.2|3.7|||Least Square Means|||||3.7|-0.2|0.0774
70858390|NCT00814801|141202962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.6207|TWO_SIDED|95.0|-1.5|2.4|||Least Square Means|||||2.4|-1.5|0.6207
70858391|NCT00814801|141202963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.8419|TWO_SIDED|95.0|-0.6|0.8|||Least Square Means|||||0.8|-0.6|0.8419
70946697|NCT03305809|141393766|SUPERIORITY||Mean Difference (Net)|0.06||||0.954|TWO_SIDED|95.0|-1.89|2.01|||ANCOVA|||Week 12||2.01|-1.89|0.954
71128085|NCT01229449|141761418|SUPERIORITY|||||||0.0001|||||||ANOVA|||||||0.0001
71128086|NCT01229449|141761418|SUPERIORITY|||||||0.72|||||||ANOVA|||||||0.72
71128087|NCT01229449|141761418|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71128088|NCT01229449|141761418|SUPERIORITY|||||||0.0005|||||||ANOVA|||||||0.0005
71128089|NCT01229449|141761418|SUPERIORITY|||||||0.0005|||||||ANOVA|||||||0.0005
71128090|NCT01229449|141761418|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71128091|NCT01229449|141761418|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71128092|NCT00418574|141761430|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.099||||0.301|TWO_SIDED|95.0|0.919|1.315|||Regression, Cox|||||1.315|0.919|0.301
71128093|NCT04836247|141761435|SUPERIORITY||Mean Difference (Final Values)|1.63|||<|0.001|TWO_SIDED|||||\<.001 is calculated p-value in SPSS.|t-test, 2 sided|||||||<.001
70946698|NCT03305809|141393766|SUPERIORITY||Mean Difference (Net)|0.59||||0.584|TWO_SIDED|95.0|-1.53|2.7|||ANCOVA|||||2.70|-1.53|0.584
70946699|NCT03305809|141393766|SUPERIORITY||Mean Difference (Net)|0.53||||0.623|TWO_SIDED|95.0|-1.59|2.65|||ANCOVA|||Week 12||2.65|-1.59|0.623
70946700|NCT03305809|141393766|SUPERIORITY||Mean Difference (Net)|1.39||||0.256|TWO_SIDED|95.0|-1.02|3.79|||ANCOVA|||Follow-up||3.79|-1.02|0.256
70946701|NCT03305809|141393766|SUPERIORITY||Mean Difference (Net)|1.41||||0.258|TWO_SIDED|95.0|-1.04|3.86|||ANCOVA|||Follow-up||3.86|-1.04|0.258
70946702|NCT03305809|141393766|SUPERIORITY||Mean Difference (Net)|4.59|||<|0.001|TWO_SIDED|95.0|1.93|7.25|||ANCOVA|||Follow-up||7.25|1.93|<0.001
70946703|NCT03305809|141393766|SUPERIORITY||Mean Difference (Net)|0.02||||0.988|TWO_SIDED|95.0|-2.47|2.51|||ANCOVA|||Follow-up||2.51|-2.47|0.988
70946704|NCT03305809|141393766|SUPERIORITY||Mean Difference (Net)|3.2||||0.02|TWO_SIDED|95.0|0.51|5.9|||ANCOVA|||Follow-up||5.90|0.51|0.020
70946705|NCT03305809|141393766|SUPERIORITY||Mean Difference (Net)|3.18||||0.022|TWO_SIDED|95.0|0.46|5.91|||ANCOVA|||Follow-up||5.91|0.46|0.022
71128094|NCT04836247|141761436|SUPERIORITY||Mean Difference (Final Values)|1.1|||<|0.001|TWO_SIDED|||||\<.001 is calculated p-value in SPSS.|t-test, 2 sided|||||||<.001
71128095|NCT04836247|141761437|SUPERIORITY||Mean Difference (Final Values)|2.61|||<|0.001|TWO_SIDED|||||\<.001 is calculated p-value in SPSS.|t-test, 2 sided|||||||<.001
71128096|NCT04836247|141761438|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.74|TWO_SIDED||||||t-test, 2 sided|||||||0.74
71128097|NCT04836247|141761439|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.76|TWO_SIDED||||||t-test, 2 sided|||||||0.76
71128098|NCT04836247|141761440|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.44|TWO_SIDED||||||t-test, 2 sided|||||||0.44
71128099|NCT03262441|141761461|OTHER||Slope|-0.00033|||||TWO_SIDED|95.0|-0.002|0.0014||||||||0.0014|-0.0020|
71128100|NCT03262441|141761462|OTHER||Slope|0.001|||||TWO_SIDED|95.0|-0.0036|0.0056||||||||0.0056|-0.0036|
71128101|NCT03262441|141761463|OTHER||Slope|0.0024|||||TWO_SIDED|95.0|-0.003|0.0078||||||||0.0078|-0.003|
71128102|NCT00559988|141761482|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.064||||0.732|TWO_SIDED|95.0|0.75|1.51|||Regression, Cox|||||1.51|0.75|0.732
71128103|NCT02249182|141761491|EQUIVALENCE|Equivalence was determined if the 90% confidence intervals (CI) were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|105.2|||||TWO_SIDED|90.0|90.61|122.13||||||AUCtau of GS-331007 for the 12 to \< 18 Years old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||122.13|90.61|
71128104|NCT02249182|141761491|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|65.76|||||TWO_SIDED|90.0|56.62|76.37||||||AUCtau of GS-331007 for the 6 to \< 12 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||76.37|56.62|
71128105|NCT02249182|141761491|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|94.08|||||TWO_SIDED|90.0|82.51|107.27||||||AUCtau of GS-331007 for the 3 to \< 6 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||107.27|82.51|
71128106|NCT02249182|141761491|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|127.18|||||TWO_SIDED|90.0|94.89|170.45||||||AUCtau of LDV for the 12 to \< 18 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||170.45|94.89|
71128107|NCT02249182|141761491|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|82.25|||||TWO_SIDED|90.0|61.34|110.3||||||AUCtau of LDV for the 6 to \< 12 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||110.30|61.34|
71128108|NCT02249182|141761491|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|120.46|||||TWO_SIDED|90.0|93.18|155.73||||||AUCtau of LDV for the 3 to \< 6 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||155.73|93.18|
71128109|NCT02249182|141761491|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|159.88|||||TWO_SIDED|90.0|137.89|185.37||||||AUCtau of SOF for the 12 to \< 18 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||185.37|137.89|
71128110|NCT02249182|141761491|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|129.48|||||TWO_SIDED|90.0|110.79|151.32||||||AUCtau of SOF for the 6 to \< 12 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||151.32|110.79|
71128111|NCT02249182|141761491|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|187.76|||||TWO_SIDED|90.0|143.41|245.82||||||AUCtau of SOF for the 3 to \< 6 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||245.82|143.41|
71128112|NCT01455194|141761512|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.122|STANDARD_ERROR_OF_MEAN|0.1175||0.2988|TWO_SIDED|95.0|-0.353|0.109|||ANCOVA|||Least square (LS) mean difference were derived from an ANCOVA model with baseline ACQ and age as covariates, and treatment, centre pool, sex, and prestudy ICS dose as factors.||0.109|-0.353|0.2988
71128113|NCT01455194|141761512|SUPERIORITY_OR_OTHER||LS Mean Difference|0.034|STANDARD_ERROR_OF_MEAN|0.118||0.7741|TWO_SIDED|95.0|-0.198|0.266|||ANCOVA|||Least square (LS) mean difference were derived from an ANCOVA model with baseline ACQ and age as covariates, and treatment, centre pool, sex, and prestudy ICS dose as factors.||0.266|-0.198|0.7741
71128114|NCT01455194|141761512|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.156|STANDARD_ERROR_OF_MEAN|0.1172||0.1835|TWO_SIDED|95.0|-0.387|0.074|||ANCOVA|||Least square (LS) mean difference were derived from an ANCOVA model with baseline ACQ and age as covariates, and treatment, centre pool, sex, and prestudy ICS dose as factors.||0.074|-0.387|0.1835
71128115|NCT01455194|141761514|SUPERIORITY_OR_OTHER||Hodges-Lehmann point estimate|0.0||||0.8465|TWO_SIDED|95.0|-3.0|4.0|||Wilcoxon (Mann-Whitney)||Treatment comparisons were carried out using an exact Wilcoxon Mann Whitney test.|||4.000|-3.000|0.8465
70858392|NCT00814801|141202963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.7942|TWO_SIDED|95.0|-0.8|0.6|||Least Square Means|||||0.6|-0.8|0.7942
70946706|NCT00816556|141393768|SUPERIORITY_OR_OTHER|||||||0.42|||||||ANOVA|||Dryness severity: P-value for the global F-test testing for all treatment arm effects equal.||||0.42
70946707|NCT00816556|141393768|SUPERIORITY_OR_OTHER|||||||0.22|||||||ANOVA|||Dryness bothersomeness: P-value for the global F-test testing for all treatment arm effects equal.||||0.22
70946708|NCT00816556|141393768|SUPERIORITY_OR_OTHER|||||||0.37|||||||ANOVA|||Itching severity: P-value for the global F-test testing for all treatment arm effects equal.||||0.37
71128116|NCT01455194|141761514|SUPERIORITY_OR_OTHER||Hodges-Lehmann point estimate|1.0||||0.4175|TWO_SIDED|95.0|-2.0|5.0|||Wilcoxon (Mann-Whitney)||Treatment comparisons were carried out using an exact Wilcoxon Mann Whitney test.|||5.000|-2.000|0.4175
71128117|NCT01455194|141761515|SUPERIORITY_OR_OTHER|||||||0.4186|||||||Fisher Exact|||Well-controlled Asthma||||0.4186
71128118|NCT01455194|141761515|SUPERIORITY_OR_OTHER|||||||0.146|||||||Fisher Exact|||Well-controlled Asthma||||0.1460
71128119|NCT01455194|141761515|SUPERIORITY_OR_OTHER|||||||0.6017|||||||Fisher Exact|||Well-controlled Asthma||||0.6017
71128120|NCT01455194|141761515|SUPERIORITY_OR_OTHER|||||||0.3305|||||||Fisher Exact|||ACQ Improvement||||0.3305
71128121|NCT01455194|141761515|SUPERIORITY_OR_OTHER|||||||0.486|||||||Fisher Exact|||ACQ Improvement||||0.4860
70946709|NCT00816556|141393768|SUPERIORITY_OR_OTHER|||||||0.27|||||||ANOVA|||Itching bothersomeness: P-value for the global F-test testing for all treatment arm effects equal.||||0.27
71128122|NCT01455194|141761515|SUPERIORITY_OR_OTHER|||||||0.8922|||||||Fisher Exact|||ACQ Improvement||||0.8922
71128123|NCT01455194|141761516|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.042|STANDARD_ERROR_OF_MEAN|0.0806||0.6062|TWO_SIDED|95.0|0.89|1.221|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|Well-controlled Asthma||1.221|0.890|0.6062
71128124|NCT01455194|141761516|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05|STANDARD_ERROR_OF_MEAN|0.0669||0.4674|TWO_SIDED|95.0|0.921|1.197|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ Improvement||1.197|0.921|0.4674
71128125|NCT01455194|141761516|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.201|STANDARD_ERROR_OF_MEAN|0.1597||0.2523|TWO_SIDED|95.0|0.878|1.642|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|Well-controlled Asthma||1.642|0.878|0.2523
71128126|NCT01455194|141761516|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.913|STANDARD_ERROR_OF_MEAN|0.1354||0.5026|TWO_SIDED|95.0|0.7|1.191|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ Improvement||1.191|0.700|0.5026
71128127|NCT01455194|141761516|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.898|STANDARD_ERROR_OF_MEAN|0.156||0.4893|TWO_SIDED|95.0|0.661|1.219|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|Well-controlled Asthma||1.219|0.661|0.4893
71128128|NCT01455194|141761516|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.181|STANDARD_ERROR_OF_MEAN|0.1351||0.2193|TWO_SIDED|95.0|0.906|1.538|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ Improvement||1.538|0.906|0.2193
70858393|NCT00814801|141202964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.3141|TWO_SIDED|95.0|-1.6|0.5|||Least Square Means|||||0.5|-1.6|0.3141
71128129|NCT01455194|141761517|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.058|STANDARD_ERROR_OF_MEAN|0.0917||0.5397|TWO_SIDED|95.0|0.884|1.266|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 0.5||1.266|0.884|0.5397
70858394|NCT00814801|141202964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.6089|TWO_SIDED|95.0|-1.3|0.8|||Least Square Means|||||0.8|-1.3|0.6089
70946710|NCT00816556|141393768|SUPERIORITY_OR_OTHER|||||||0.46|||||||ANOVA|||Burning severity: P-value for the global F-test testing for all treatment arm effects equal.||||0.46
70946711|NCT00816556|141393768|SUPERIORITY_OR_OTHER|||||||0.67|||||||ANOVA|||Burning bothersomeness: P-value for the global F-test testing for all treatment arm effects equal.||||0.67
70946712|NCT00816556|141393769|SUPERIORITY_OR_OTHER|||||||0.33|||||||ANOVA|||Baseline vs. week 2: P-value for the global F-test testing for all treatment arm effects equal.||||0.33
71128130|NCT01455194|141761517|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.005|STANDARD_ERROR_OF_MEAN|0.0738||0.9458|TWO_SIDED|95.0|0.87|1.161|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.0||1.161|0.870|0.9458
71128131|NCT01455194|141761517|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.026|STANDARD_ERROR_OF_MEAN|0.0708||0.7213|TWO_SIDED|95.0|0.893|1.178|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.25||1.178|0.893|0.7213
71128132|NCT01455194|141761517|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05|STANDARD_ERROR_OF_MEAN|0.0692||0.4807|TWO_SIDED|95.0|0.917|1.202|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.5||1.202|0.917|0.4807
71128133|NCT01455194|141761517|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.326|STANDARD_ERROR_OF_MEAN|0.1791||0.115|TWO_SIDED|95.0|0.934|1.884|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 0.5||1.884|0.934|0.1150
71128134|NCT01455194|141761517|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.074|STANDARD_ERROR_OF_MEAN|0.1467||0.6281|TWO_SIDED|95.0|0.805|1.431|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.0||1.431|0.805|0.6281
71128135|NCT01455194|141761517|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.059|STANDARD_ERROR_OF_MEAN|0.1415||0.6853|TWO_SIDED|95.0|0.803|1.397|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.25||1.397|0.803|0.6853
71128136|NCT01455194|141761517|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.055|STANDARD_ERROR_OF_MEAN|0.1388||0.6995|TWO_SIDED|95.0|0.804|1.385|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.5||1.385|0.804|0.6995
71128137|NCT01455194|141761517|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.837|STANDARD_ERROR_OF_MEAN|0.1744||0.308|TWO_SIDED|95.0|0.595|1.178|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 0.5||1.178|0.595|0.3080
71128138|NCT01455194|141761517|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.939|STANDARD_ERROR_OF_MEAN|0.1461||0.6645|TWO_SIDED|95.0|0.705|1.25|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.0||1.250|0.705|0.6645
70946713|NCT00816556|141393769|SUPERIORITY_OR_OTHER|||||||0.99|||||||ANOVA|||Baseline vs. week 12: P-value for the global F-test testing for all treatment arm effects equal.||||0.99
70946714|NCT00816556|141393769|SUPERIORITY_OR_OTHER|||||||0.58|||||||ANOVA|||Week 2 vs. week 12: P-value for the global F-test testing for all treatment arm effects equal.||||0.58
70946715|NCT00816556|141393770|SUPERIORITY_OR_OTHER|||||||0.007|||||||ANOVA|||Baseline vs. week 2: P-value for the global F-test testing for all treatment arm effects equal.||||0.007
71128139|NCT01455194|141761517|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.992|STANDARD_ERROR_OF_MEAN|0.1408||0.9564|TWO_SIDED|95.0|0.753|1.308|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.25||1.308|0.753|0.9564
71128140|NCT01455194|141761517|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.047|STANDARD_ERROR_OF_MEAN|0.1375||0.7367|TWO_SIDED|95.0|0.8|1.371|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.5||1.371|0.800|0.7367
71128141|NCT01455194|141761518|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.367|STANDARD_ERROR_OF_MEAN|0.2583||0.2264|TWO_SIDED|95.0|0.824|2.267|||Log Rank||A hazard ratio of \<1 represented a benefit for the test treatment.|||2.267|0.824|0.2264
71128142|NCT01455194|141761518|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.102|STANDARD_ERROR_OF_MEAN|0.5001||0.1373|TWO_SIDED|95.0|0.789|5.602|||Log Rank||A hazard ratio of \<1 represented a benefit for the test treatment.|||5.602|0.789|0.1373
71128143|NCT01455194|141761518|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.882|STANDARD_ERROR_OF_MEAN|0.4365||0.7732|TWO_SIDED|95.0|0.375|2.074|||Log Rank||A hazard ratio of \<1 represented a benefit for the test treatment.|||2.074|0.375|0.7732
71128144|NCT01455194|141761519|SUPERIORITY_OR_OTHER|||||||0.288|||||||Fisher Exact|||||||0.2880
71128145|NCT01455194|141761519|SUPERIORITY_OR_OTHER|||||||0.2864|||||||Fisher Exact|||||||0.2864
71128146|NCT03274518|141761525|NON_INFERIORITY|The non-inferiority margin was defined as difference within 20% in comparison to reference method (olHDF)||||||0.4534|||||||t-test, 2 sided|||||||0.4534
71128147|NCT03274518|141761526|NON_INFERIORITY|The non-inferiority margin was defined as difference within 20% in comparison to reference method (olHDF)||||||0.1179|||||||t-test, 2 sided|||||||0.1179
71128148|NCT03274518|141761527|NON_INFERIORITY|The non-inferiority margin was defined as difference within 20% in comparison to reference method (olHDF)||||||0.3054|||||||t-test, 2 sided|||||||0.3054
71128149|NCT03274518|141761528|NON_INFERIORITY|The lower the ECW/TBW ratio, the lower pre-dialysis excess fluid. A non-inferiority margin was defined as difference within 10% from reference method (olHDF)||||||0.045|||||||t-test, 2 sided|||||||0.045
70858395|NCT02751931|141202982|OTHER||Mean Difference (Net)|72.09|||<|0.001|TWO_SIDED|95.0|45.28|98.89||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||98.89|45.28|<0.001
70946716|NCT00816556|141393770|SUPERIORITY_OR_OTHER|||||||0.32|||||||ANOVA|||Baseline vs. week 12: P-value for the global F-test testing for all treatment arm effects equal.||||0.32
70946717|NCT00816556|141393770|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANOVA|||Week 2 vs. week 12: P-value for the global F-test testing for all treatment arm effects equal.||||0.02
70946718|NCT03546816|141393799|SUPERIORITY|||||||0.229||||||P-value from a Cochran-Mantel-Haenszel (CMH) test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||||||0.229
70946719|NCT03546816|141393800|SUPERIORITY|||||||0.013||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||||||0.013
70946720|NCT03546816|141393801|SUPERIORITY|||||||0.236||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||||||0.236
71128150|NCT03916484|141761538|OTHER|||||||0.33||||||No a priori threshold for statistical significance was specified.|Kruskal-Wallis|||||||0.33
71128151|NCT03916484|141761539|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
71128152|NCT03916484|141761539|OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
71128153|NCT03916484|141761539|OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
71128154|NCT03916484|141761539|OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
71128155|NCT03916484|141761539|OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
71128156|NCT03916484|141761540|OTHER|||||||0.45||||||No a priori threshold for statistical significance was specified.|Fisher Exact|||||||0.45
71128157|NCT03916484|141761541|OTHER||||||<|0.001|||||||McNemar|||||||<0.001
71128158|NCT03916484|141761541|OTHER|||||||0.07|||||||McNemar|||||||0.07
71128159|NCT03916484|141761541|OTHER|||||||0.003|||||||McNemar|||||||0.003
71128160|NCT03916484|141761542|OTHER|||||||0.25|||||||McNemar|||||||0.25
71128161|NCT03916484|141761542|OTHER|||||||0.002|||||||McNemar|||||||0.002
71128162|NCT03916484|141761542|OTHER|||||||0.453|||||||McNemar|||||||0.453
71128163|NCT03916484|141761542|OTHER|||||||0.5|||||||McNemar|||||||0.500
71128164|NCT03916484|141761542|OTHER|||||||0.003|||||||McNemar|||||||0.003
71128165|NCT01092663|141761556|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
71128166|NCT01092663|141761557|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
71128167|NCT01092663|141761558|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effects between the 2 groups||||>0.05
71128168|NCT01092663|141761559|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
71128169|NCT01092663|141761560|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
71128170|NCT01092663|141761561|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||<0.05
71128171|NCT01092663|141761562|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Treament difference in fasting EGP between the 2 groups were compared.||||>0.05
71128172|NCT01092663|141761563|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between groups was evaluated||||>0.05
71128173|NCT01092663|141761564|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired ttest||Difference in treatment effect between groups was evaluated||||>0.05
70858396|NCT02751931|141202982|OTHER||Mean Difference (Net)|113.21|||<|0.001|TWO_SIDED|95.0|78.95|147.47||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||147.47|78.95|<0.001
71128174|NCT01092663|141761565|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
71128175|NCT01092663|141761566|SUPERIORITY_OR_OTHER||||||=|0.01||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||=0.01
71128176|NCT01092663|141761567|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||differerences in treatment effect between the 2 groups||||>0.05
71128177|NCT01092663|141761568|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
71128178|NCT01092663|141761569|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
71128179|NCT01092663|141761570|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
71128180|NCT01092663|141761571|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
71128181|NCT01092663|141761572|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||<0.05
71128182|NCT01092663|141761573|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||<0.05
71128183|NCT01092663|141761574|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||<0.01
71128184|NCT01092663|141761575|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||<0.01
71128185|NCT01092663|141761576|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
71128186|NCT00781859|141761751|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.56||||0.003|TWO_SIDED|95.0|1.32|5.24||comparing placebo and ocriplasmin|Fisher Exact|||||5.24|1.32|0.003
70858397|NCT02751931|141202983|OTHER||Mean Difference (Net)|-4.09||||0.618|TWO_SIDED|95.0|-20.55|12.38||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||12.38|-20.55|0.618
71128187|NCT05546229|141761755|OTHER|||||||0.0049|||||||t-test, 2 sided|8 degrees of freedom||patient plasma versus isf value for methadone||||.0049
71128188|NCT05546229|141761756|OTHER|||||||0.0025|||||||t-test, 2 sided|8 degrees of freedom||||||.0025
70858398|NCT02751931|141202983|OTHER||Mean Difference (Net)|15.16||||0.005|TWO_SIDED|95.0|5.1|25.22||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||25.22|5.10|0.005
71128189|NCT01220180|141761775|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71128190|NCT01220180|141761776|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71128191|NCT01220180|141761777|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71128192|NCT01220180|141761778|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71128193|NCT01220180|141761779|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71128194|NCT01220180|141761780|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71128195|NCT01220180|141761781|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71128196|NCT01220180|141761782|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71128197|NCT02713659|141761797|EQUIVALENCE|0.05||||||0.85|||||||t-test, 2 sided|||Auditory standard score between infants at 6 months and 24 months of age in the Early literacy arm and the standard literacy arm||||0.85
71128198|NCT02713659|141761797|EQUIVALENCE|0.05||||||0.53|||||||t-test, 2 sided|||Expressive standard score between infants at 6 months and 24 months of age in the Early literacy arm and the standard literacy arm||||0.53
71128199|NCT02713659|141761797|EQUIVALENCE|0.05||||||0.49|||||||t-test, 2 sided|||Total standard score between infants at 6 months and 24 months of age in the Early literacy arm and the standard literacy arm||||0.49
71128200|NCT02713659|141761798|EQUIVALENCE|0.05||||||0.57|||||||t-test, 2 sided|||Total read scale score between infants at 6 months and 24 months of age in the early literacy arm and the standard literacy arm||||0.57
71128201|NCT02713659|141761799|EQUIVALENCE|0.05||||||0.23|||||||Chi-squared|||Number of up to date child well visits between the early literacy arm and the standard literacy arm at 6 months of age||||0.23
71128202|NCT02713659|141761799|EQUIVALENCE|0.05||||||0.71|||||||Chi-squared|||Number of up to date child vaccinations between the early literacy arm and the standard literacy arm at 6 months of age||||0.71
71128203|NCT04943432|141761807|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||T2 - T1||||0.06
71128204|NCT04943432|141761807|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||T3 - T1||||0.68
71128205|NCT04943432|141761809|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||T2-T1||||.01
71128206|NCT04943432|141761809|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||T3-T1||||.32
71128207|NCT04943432|141761810|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||T2-T1||||.44
71128208|NCT04943432|141761810|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||T3-T1||||.007
71128209|NCT04943432|141761814|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||T2-T1||||.01
71128210|NCT04943432|141761814|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||T3-T1||||.11
71128211|NCT04943432|141761815|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||T2-T1||||.82
71128212|NCT04943432|141761815|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||T3-T1||||.36
71128213|NCT04943432|141761816|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|||T2-T1||||.34
71128214|NCT04943432|141761816|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||T3-T1||||.02
71128215|NCT04943432|141761818|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||T2-T1||||.14
71128216|NCT04943432|141761818|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||T3-T1||||.29
71128217|NCT04943432|141761820|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||T2-T1||||<.001
71128218|NCT04943432|141761820|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||T3-T1||||.23
70858399|NCT02751931|141202983|OTHER||Mean Difference (Net)|14.62||||0.055|TWO_SIDED|95.0|-0.31|29.54||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||29.54|-0.31|0.055
70858400|NCT02751931|141202983|OTHER||Mean Difference (Net)|13.59|||<|0.001|TWO_SIDED|95.0|6.75|20.42||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||20.42|6.75|<0.001
70946721|NCT03546816|141393802|SUPERIORITY|||||||0.083||||||P-values, least squares means (LS Mean) and standard deviations (LS SD) from an analysis of covariance (ANCOVA) with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 2||||0.083
70858401|NCT02751931|141202984|OTHER||Mean Difference (Net)|41.36|||<|0.001|TWO_SIDED|95.0|18.75|63.97||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change from Baseline at week 4 - Children.||63.97|18.75|<0.001
70946722|NCT03546816|141393802|SUPERIORITY|||||||0.049||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 4||||0.049
70858402|NCT02751931|141202984|OTHER||Mean Difference (Net)|80.78|||<|0.001|TWO_SIDED|95.0|39.2|122.36||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||122.36|39.20|<0.001
70858403|NCT02751931|141202985|OTHER||Mean Difference (Net)|0.44||||0.632|TWO_SIDED|95.0|-1.4|2.28||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||2.28|-1.40|0.632
70946723|NCT03546816|141393802|SUPERIORITY|||||||0.081||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 6||||0.081
71128219|NCT01727414|141761845|SUPERIORITY|General linear mixed models were used to evaluate the subtype\*dose interaction to determine if the subtypes have unique MPH dose-response curves, with the outcome being Attention Deficit Hyperactivity Disorder total symptom scores (minimum=0, maximum=54, higher=worse)|Slope|0.29|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
71128220|NCT02684188|141761864|SUPERIORITY|||||||0.03||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 3 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 3.|For day 3, 112(68 baseline and 44 intervention) patients were used in this analysis.|||0.030
71128221|NCT02684188|141761864|SUPERIORITY|||||||0.025||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 7 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 7.|For day 7, 110 (66 baseline and 44 intervention) patients were used in this analysis.|||0.025
71128222|NCT02684188|141761864|SUPERIORITY|||||||0.037||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 14 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 14.|For day 14, 104 (61 baseline and 43 intervention) patients were used in this analysis.|||0.037
70946724|NCT03546816|141393802|SUPERIORITY|||||||0.157||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.157
70946725|NCT03546816|141393803|SUPERIORITY|||||||0.151||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||At Week 2||||0.151
70946726|NCT03546816|141393803|SUPERIORITY|||||||0.052||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||At Week 4||||0.052
71128223|NCT02684188|141761864|SUPERIORITY|||||||0.011||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 21 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 21.|For day 21, 98 (57 baseline and 41 intervention) patients were used in this analysis.|||0.011
71128224|NCT02684188|141761864|SUPERIORITY|||||||0.05||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 30 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 30.|For day 30, 95 (56 baseline and 39 intervention) patients were used in this analysis.|||0.050
71128225|NCT02684188|141761864|SUPERIORITY|||||||0.055|||||||Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 60 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 60.|For day 60, 87 (53 baseline and 34 intervention) patients were used in this analysis.|||0.055
71128226|NCT02684188|141761864|SUPERIORITY|||||||0.137||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 90 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 90.|For day 90, 83 (49 baseline and 34 intervention) patients were used in this analysis.|||0.137
70946727|NCT03546816|141393803|SUPERIORITY|||||||0.175||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||At Week 10||||0.175
70946728|NCT03546816|141393804|SUPERIORITY|||||||0.475||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 2||||0.475
70946729|NCT03546816|141393804|SUPERIORITY|||||||0.02||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 4||||0.020
70946730|NCT03546816|141393804|SUPERIORITY|||||||0.492||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.492
70946731|NCT03546816|141393805|SUPERIORITY|||||||0.175||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 2||||0.175
70946732|NCT03546816|141393805|SUPERIORITY|||||||0.169||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 4||||0.169
70946733|NCT03546816|141393805|SUPERIORITY|||||||0.516||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.516
70946734|NCT03546816|141393806|SUPERIORITY|||||||0.814||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.814
70946735|NCT03546816|141393807|SUPERIORITY|||||||0.113||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.113
70858404|NCT02751931|141202985|OTHER||Mean Difference (Net)|-0.64||||0.321|TWO_SIDED|95.0|-1.94|0.67|||t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||0.67|-1.94|0.321
70946736|NCT01161446|141393809|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71128227|NCT02684188|141761865|SUPERIORITY|||||||0.279||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 3 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 3.|For day 3, 112(68 baseline and 44 intervention) patients were used in this analysis.|||0.279
71128228|NCT02684188|141761865|SUPERIORITY|||||||0.211||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 7 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 7.|For day 7, 110 (66 baseline and 44 intervention) patients were used in this analysis.|||0.211
71128229|NCT02684188|141761865|SUPERIORITY|||||||0.424||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 14 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 14.|For day 14, 104 (61 baseline and 43 intervention) patients were used in this analysis.|||0.424
70858405|NCT02751931|141202985|OTHER||Mean Difference (Net)|-1.86||||0.011|TWO_SIDED|95.0|-3.27|-0.45||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||-0.45|-3.27|0.011
71128230|NCT02684188|141761865|SUPERIORITY|||||||0.191||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 21 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 21.|For day 21, 98 (57 baseline and 41 intervention) patients were used in this analysis.|||0.191
71128231|NCT02684188|141761865|SUPERIORITY|||||||0.478||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 30 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 30.|For day 30, 95 (56 baseline and 39 intervention) patients were used in this analysis.|||0.478
71128232|NCT02684188|141761865|SUPERIORITY|||||||0.452||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 60 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 60.|For day 60, 87 (53 baseline and 34 intervention) patients were used in this analysis.|||0.452
71128233|NCT02684188|141761865|SUPERIORITY|H0: There is no difference in the proportion of patients with at least one ED visits by day 90 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 90.||||||0.381||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic||||For day 90, 83 (49 baseline and 34 intervention) patients were used in this analysis.|||0.381
71128234|NCT02684188|141761866|SUPERIORITY|||||||0.502||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 3 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 3.|For day 3, 115 (70 baseline and 45 intervention) patients were used in this analysis.|||0.502
71128235|NCT02684188|141761866|SUPERIORITY|||||||0.286||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 7 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 7.|For day 7, 113 (68 baseline and 45 intervention) patients were used in this analysis.|||0.286
71128236|NCT02684188|141761866|SUPERIORITY|||||||0.347||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 14 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 14.|For day 14, 107 (63 baseline and 44 intervention) patients were used in this analysis.|||0.347
71128237|NCT02684188|141761866|SUPERIORITY|||||||0.25||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 21 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 21.|For day 21, 101 (59 baseline and 42 intervention) patients were used in this analysis.|||0.250
70858406|NCT02751931|141202985|OTHER||Mean Difference (Net)|-0.77||||0.359|TWO_SIDED|95.0|-2.49|0.94||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||0.94|-2.49|0.359
70858407|NCT02751931|141202986|OTHER||Mean Difference (Net)|-12.38|||<|0.001|TWO_SIDED|95.0|-18.56|-6.21||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||-6.21|-18.56|<0.001
70946737|NCT01161446|141393810|NON_INFERIORITY|Non-inferiority bound: Self-testing was to be considered non-inferior to standard testing if the upper bound of the 95% confidence interval for the odds ratio fell below 2.|Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.61|1.9|||Regression, Logistic|Used generalized estimating equations with exchangeable working correlation and robust standard errors to account for repeated measures.|The home testing arm represents the numerator and the standard testing arm the denominator.|||1.90|0.61|
70858408|NCT02751931|141202986|OTHER||Mean Difference (Net)|-6.48||||0.334|TWO_SIDED|95.0|-20.09|7.13||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||7.13|-20.09|0.334
70858409|NCT02751931|141202986|OTHER||Mean Difference (Net)|-18.11|||<|0.001|TWO_SIDED|95.0|-24.87|-11.35||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||-11.35|-24.87|<0.001
70858410|NCT02751931|141202986|OTHER||Mean Difference (Net)|-13.19||||0.005||95.0|-22.02|-4.36||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||-4.36|-22.02|0.005
70858411|NCT02751931|141202987|OTHER||||||<|0.001||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 4 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 4 - Children||||<0.001
70858412|NCT02751931|141202987|OTHER|||||||0.148||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 4 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 4 - Adolescents||||0.148
70858413|NCT02751931|141202987|OTHER|||||||0.002||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 24 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 24 - Children||||0.002
71128238|NCT02684188|141761866|SUPERIORITY|||||||0.22||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 30 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 30.|For day 30, 98 (58 baseline and 40 intervention) patients were used in this analysis.|||0.220
71128239|NCT02684188|141761866|SUPERIORITY|||||||0.116||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 60 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 60.|For day 60, 90 (55 baseline and 35 intervention) patients were used in this analysis.|||0.116
71128240|NCT02684188|141761866|SUPERIORITY|||||||0.126||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 90 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 90.|For day 90, 86 (51 baseline and 35 intervention) patients were used in this analysis.|||0.126
71128241|NCT02684188|141761867|SUPERIORITY|||||||0.597||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 3; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 3.|For day 3, 115 (70 baseline and 45 intervention) patients were used in this analysis.|||0.597
71128242|NCT02684188|141761867|SUPERIORITY|||||||0.504||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 7; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 7.|For day 7, 113 (68 baseline and 45 intervention) patients were used in this analysis.|||0.504
71128243|NCT02684188|141761867|SUPERIORITY|||||||0.558||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 14; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 14.|For day 14, 107 (63 baseline and 44 intervention) patients were used in this analysis.|||0.558
71128244|NCT02684188|141761867|SUPERIORITY|||||||0.472||||||Comments (covariates): P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 21; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 21.|For day 21, 101 (59 baseline and 42 intervention) patients were used in this analysis.|||0.472
71128245|NCT02684188|141761867|SUPERIORITY|||||||0.462||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 30; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 30.|For day 30, 98 (58 baseline and 40 intervention) patients were used in this analysis.|||0.462
70858414|NCT02751931|141202987|OTHER|||||||0.039||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 24 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 24 - Adolescents||||0.039
70858415|NCT02751931|141202988|OTHER||||||<|0.001||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 4 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 4 - Children||||<0.001
70858416|NCT02751931|141202988|OTHER|||||||0.007||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 4 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 4 - Adolescents||||0.007
70858417|NCT02751931|141202988|OTHER||||||<|0.001||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 24 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 24 - Children||||< 0.001
70858418|NCT02751931|141202988|OTHER||||||<|0.001||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 24 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 24 - Adolescents||||< 0.001
70858419|NCT02751931|141202989|OTHER||||||<|0.001||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline was equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||||<0.001
70858420|NCT02751931|141202989|OTHER|||||||0.006||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline was equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||||0.006
71128246|NCT02684188|141761867|SUPERIORITY|||||||0.394||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 60; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 60.|For day 60, 90 (55 baseline and 35 intervention) patients were used in this analysis.|||0.394
71128247|NCT02684188|141761867|SUPERIORITY|||||||0.368||||||Comments (covariates): P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 90; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 90.|For day 90, 86 (51 baseline and 35 intervention) patients were used in this analysis.|||0.368
71128248|NCT02684188|141761868|SUPERIORITY|||||||0.946||||||P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE+ score.|Poisson regression|||The following hypotheses were tested: H0: There is no difference in the cumulative number of PCP visits for day 3 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 3.|For day 3, 114 (70 baseline and 44 intervention) patients were used in this analysis.|||0.946
71128249|NCT02684188|141761868|SUPERIORITY|||||||0.613|||||||Poisson regression|||H0: There is no difference in the cumulative number of PCP visits for day 7 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 7.|For day 7, 111 (67 baseline and 44 intervention) patients were used in this analysis.|||0.613
71128250|NCT02684188|141761868|SUPERIORITY|||||||0.541||||||P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE+ score.|Poisson regression|||H0: There is no difference in the cumulative number of PCP visits for day 14 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 14.|For day 14, 105 (62 baseline and 43 intervention) patients were used in this analysis.|||0.541
70946738|NCT01161446|141393811|NON_INFERIORITY|Home testing was to be considered non-inferior to standard testing with respect to STI prevalence if the upper bound of the 95% confidence interval for the difference between the two arms (home - standard) fell below 10%.|Difference in proportions|-0.068|||||TWO_SIDED|95.0|-0.16|0.016||||||||0.016|-0.16|
71128251|NCT02684188|141761868|SUPERIORITY|||||||0.765||||||P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE score.|Poisson regression|||H0: There is no difference in the cumulative number of PCP visits for day 21 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 21.|For day 21, 98 (58 baseline and 40 intervention) patients were used in this analysis.|||0.765
71128252|NCT02684188|141761868|SUPERIORITY|||||||0.919||||||P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE+ score.|Poisson regression|||H0: There is no difference in the cumulative number of PCP visits for day 30 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 30.|For day 30, 95 (57 baseline and 38 intervention) patients were used in this analysis.|||0.919
71128253|NCT02684188|141761868|SUPERIORITY|||||||0.999||||||P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE score.|Poisson regression|P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE score.||H0: There is no difference in the cumulative number of PCP visits for day 60 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 60.|For day 60, 87 (54 baseline and 33 intervention) patients were used in this analysis.|||0.999
71128254|NCT02684188|141761868|SUPERIORITY|||||||0.995|||||||Poisson regression|||H0: There is no difference in the cumulative number of PCP visits for day 90 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 90.|For day 90, 83 (50 baseline and 33 intervention) patients were used in this analysis.|||0.995
71128255|NCT02684188|141761869|EQUIVALENCE|A repeated measures ANOVA model was used to model the SF12 Physical Health score as a function of treatment group. The likelihood ratio test was used to calculate the p-values for the treatment effect and covariates. No adjustments for multiple comparisons were made. Hypotheses were tested after adjusting for the effects of the repeated measures, patient age, and the number of people in a household. All hypotheses were 2-sided and p-values \< 0.05 were considered statistically significant.||||||0.371||||||The P-value comparing the means for the 2 groups averaged across the 7 days is p = 0.371, after adjusting for covariates.|ANOVA|||The following hypotheses were tested: Hoi: There is no difference in mean SF12 Physical Health scores between the standard and enhanced discharge groups (null hypothesis); H1i: The mean SF12 Physical Health scores differ between the standard and enhanced discharge groups.||||0.371
70858421|NCT02751931|141202989|OTHER||||||<|0.001||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline was equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||||< 0.001
70946739|NCT01161446|141393812|NON_INFERIORITY|Self-testing was to be considered non-inferior with respect to the number of reported male CAI partners if the upper bound of the 95% CI for the fold-difference in the number of partners between the two arms (self ÷ standard testing) fell below 2.|Incidence Rate Ratio|0.92|||||TWO_SIDED|95.0|0.64|1.33|||Poisson regression|Used generalized estimating equations with exchangeable working correlation and robust standard errors to account for repeated measures.|The home testing arm represents the numerator and the standard testing arm the denominator.|||1.33|0.64|
70946740|NCT02312206|141393890|SUPERIORITY||Hazard Ratio (HR)|0.826||||0.3028|TWO_SIDED|95.0|0.5735|1.1889|||Log Rank|||||1.1889|0.5735|0.3028
70946741|NCT01006616|141393898|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.031||||0.325|TWO_SIDED|95.0|-0.03|0.091|||Constrained Longitudinal Data Analysis|Model with treatment, time, treatment by time interaction, and baseline smoking status (yes/no) and inhaled corticosteroid (ICS) use (yes/no)||||0.091|-0.030|0.325
70946742|NCT01006616|141393898|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.029||||0.37|TWO_SIDED|95.0|-0.091|0.034|||Constrained Longitudinal Data Analysis|Model with treatment, time, treatment by time interaction, and baseline smoking status (yes/no) and ICS use (yes/no)||||0.034|-0.091|0.370
71128256|NCT02684188|141761870|EQUIVALENCE|A repeated measures ANOVA model was used to model the SF-12 Mental Health score as a function of treatment group. The likelihood ratio test was used to calculate the p-values for the treatment effect and covariates. No adjustments for multiple comparisons were made. Hypotheses were tested after adjusting for the effects of the repeated measures, patient age, income, and county. All hypotheses were 2-sided and p-values \< 0.05 were considered statistically significant.||||||0.232||||||The P-value comparing the means for the 2 groups averaged across the 7 days is p = 0.232, after adjusting for covariates.|ANOVA|||The following hypotheses were tested: Hoi: There is no difference in mean SF-12 Mental Health scores between the standard and enhanced discharge groups (null hypothesis); H1i: The mean SF-12 Mental Health scores differ between the standard and enhanced discharge groups.||||0.232
71128257|NCT02684188|141761871|SUPERIORITY|||||||0.806|||||||ANCOVA|||The following hypotheses were tested: H0: There is no difference in the mean CTM3 score between the standard and enhanced discharge groups (null hypothesis); H1: Patients in the enhanced discharge group will have a higher mean CTM3 rating than patients in the standard discharge group.|An analysis of covariance was used to model the CTM3 discharge planning score as a function of treatment group. An ANOVA F-test was used to calculate the p-values for the treatment effect and covariates. No adjustments for multiple comparisons were made. Hypotheses were tested after adjusting for the effects of patient age and income. The hypothesis test for the group comparison was 1-sided, hypotheses to assess significance of covariates were 2-sided, and p-values \< 0.05 were considered statistically significant. The covariates Sex, County, Number in Household, LACE+ score, and PAM10 score did not differ in their mean CTM3 scores so were not retained in the model.|||0.806
71128258|NCT02684188|141761872|SUPERIORITY|||||||0.742|||||||ANOVA|||The following hypotheses were tested: H0: There is no difference in the mean RTM14 score between the standard and enhanced discharge groups (null hypothesis); H1: Patients in the enhanced discharge group will have a higher mean RTM14 rating than patients in the standard discharge group.|A repeated measures ANOVA model (over the 6 time measurement periods) was used to model the RTM14 score as a function of treatment group. The likelihood ratio test was used to calculate the p-values for the treatment effect and covariates. No adjustments for multiple comparisons were made. Hypotheses were tested after adjusting for the effects of the repeated measures, patient age, income, and whether or not a patient had visited a hospital or ED prior to that day. The hypothesis test for the group comparison was 1-sided, hypotheses to assess significance of covariates were 2-sided, and p-values \< 0.05 were considered statistically significant. The covariates Sex, Number in household, LACE+ score, and PAM10 score were not significant in explaining SF-12 scores so were not retained in the model.|||0.742
71128259|NCT02684188|141761873|SUPERIORITY|||||||0.717||||||This Hypothesis was tested with no adjustments for covariates since none were significant.|Regression, Logistic|||: H0: There is no difference in the cumulative number of PCP visits for day 3 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 3.|For day 3, 114 (70 baseline and 44 intervention) patients were used in this analysis.|||0.717
71128260|NCT02684188|141761873|SUPERIORITY|||||||0.479||||||This Hypothesis was tested with no adjustments for covariates since none were significant.|Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 7 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 7.|For day 7, 111 (67 baseline and 44 intervention) patients were used in this analysis.|||0.479
71128261|NCT02684188|141761873|SUPERIORITY|||||||0.329|||||||Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 14 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 14.|For day 14, 105 (62 baseline and 43 intervention) patients were used in this analysis.|||0.329
71128262|NCT02684188|141761873|SUPERIORITY|||||||0.78|||||||Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 21 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 21.|This Hypothesis was tested with no adjustments for covariates since none were significant.|||0.780
71128263|NCT02684188|141761873|SUPERIORITY|||||||0.779||||||This Hypothesis was tested with no adjustments for covariates since none were significant.|Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 30 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 30.|For day 30, 95 (57 baseline and 38 intervention) patients were used in this analysis.|||0.779
70858422|NCT02751931|141202989|OTHER|||||||0.001||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline was equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||||0.001
70858423|NCT02751931|141202990|OTHER||Mean Difference (Net)|14.58||||0.035|TWO_SIDED|95.0|1.0|28.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||28.1|1.0|0.035
70858424|NCT02751931|141202990|OTHER||Mean Difference (Net)|35.99||||0.003|TWO_SIDED|95.0|13.1|58.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||58.9|13.1|0.003
70858425|NCT02751931|141202990|OTHER||Mean Difference (Net)|30.08|||<|0.001|TWO_SIDED|95.0|14.7|45.5||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||45.5|14.7|<0.001
70858426|NCT02751931|141202990|OTHER||Mean Difference (Net)|51.96|||<|0.001|TWO_SIDED|95.0|24.6|79.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||79.3|24.6|<0.001
70858427|NCT02751931|141202990|OTHER||Mean Difference (Net)|36.9|||<|0.001|TWO_SIDED|95.0|22.7|51.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||51.1|22.7|<0.001
70858428|NCT02751931|141202990|OTHER||Mean Difference (Net)|45.1|||<|0.001|TWO_SIDED|95.0|21.3|68.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||68.9|21.3|<0.001
70858429|NCT02751931|141202990|OTHER||Mean Difference (Net)|32.25|||<|0.001|TWO_SIDED|95.0|18.2|46.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children||46.3|18.2|<0.001
71128264|NCT02684188|141761873|SUPERIORITY|||||||0.848||||||This Hypothesis was tested with no adjustments for covariates since none were significant.|Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 60 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 60.|For day 60, 87 (54 baseline and 33 intervention) patients were used in this analysis.|||0.848
71128265|NCT02684188|141761873|SUPERIORITY|||||||0.857||||||This Hypothesis was tested with no adjustments for covariates since none were significant.|Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 90 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 90.|For day 90, 83 (50 baseline and 33 intervention) patients were used in this analysis.|||0.857
70858430|NCT02751931|141202990|OTHER||Mean Difference (Net)|43.94||||0.001|TWO_SIDED|95.0|19.2|68.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||68.6|19.2|0.001
70858431|NCT02751931|141202990|OTHER||Mean Difference (Net)|41.63|||<|0.001|TWO_SIDED|95.0|23.3|60.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||60.0|23.3|<0.001
70858432|NCT02751931|141202990|OTHER||Mean Difference (Net)|59.31||||0.002|TWO_SIDED|95.0|23.8|94.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||94.9|23.8|0.002
70858433|NCT02751931|141202990|OTHER||Mean Difference (Net)|53.87|||<|0.001|TWO_SIDED|95.0|24.5|83.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||83.2|24.5|<0.001
70858434|NCT02751931|141202990|OTHER||Mean Difference (Net)|52.14||||0.002|TWO_SIDED|95.0|20.5|83.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||83.8|20.5|0.002
70858435|NCT02751931|141202990|OTHER||Mean Difference (Net)|42.84|||<|0.001|TWO_SIDED|95.0|22.0|63.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||63.7|22.0|<0.001
71128266|NCT00488826|141761874|SUPERIORITY_OR_OTHER||Geometric mean ratio|1097.0||||||90.0|793.6|1461.0||P-Values were not calculated.|||This analysis is for Serotype 4.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||1461|793.6|
70858436|NCT02751931|141202990|OTHER||Mean Difference (Net)|42.4||||0.008|TWO_SIDED|95.0|12.5|72.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||72.3|12.5|0.008
70858437|NCT02751931|141202991|OTHER||Mean Difference (Net)|17.5||||0.126|TWO_SIDED|95.0|-5.1|40.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||40.1|-5.1|0.126
70858438|NCT02751931|141202991|OTHER||Mean Difference (Net)|42.38||||0.014|TWO_SIDED|95.0|9.3|75.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||75.4|9.3|0.014
70858439|NCT02751931|141202991|OTHER||Mean Difference (Net)|46.69|||<|0.001|TWO_SIDED|95.0|21.7|71.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||71.7|21.7|<0.001
70858440|NCT02751931|141202991|OTHER||Mean Difference (Net)|73.25||||0.002|TWO_SIDED|95.0|29.3|117.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||117.2|29.3|0.002
70946743|NCT01006616|141393898|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.067||||0.037|TWO_SIDED|95.0|0.004|0.131|||Constrained Longitudinal Data Analysis|Model with treatment, time, treatment by time interaction, and baseline smoking status (yes/no) and ICS use (yes/no)||||0.131|0.004|0.037
70946744|NCT01006616|141393899|SUPERIORITY_OR_OTHER||Difference in percentages|2.6||||0.096|TWO_SIDED|95.0|-0.6|6.9|||Miettinen and Nurminen||Analysis of Week 26 data|||6.9|-0.6|0.096
71128267|NCT00488826|141761874|SUPERIORITY_OR_OTHER||Geometric mean ratio|54.6||||||90.0|35.36|85.49||P-Values were not calculated.|||This analysis is for Serotype 6B.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||85.49|35.36|
71128268|NCT00488826|141761874|SUPERIORITY_OR_OTHER||Geometric mean ratio|99.48||||||90.0|79.81|142.0||P-Values were not calculated.|||This analysis is for Serotype 9V|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||142.0|79.81|
71128269|NCT00488826|141761874|SUPERIORITY_OR_OTHER||Geometric mean ratio|134.3||||||90.0|80.83|197.1||P-Values were not calculated.|||This analysis is for Serotype 14.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||197.1|80.83|
71128270|NCT00488826|141761874|SUPERIORITY_OR_OTHER||Geometric mean ratio|200.3||||||90.0|151.9|302.4||P-Values were not calculated.|||This analysis is for Serotype 18C.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||302.4|151.9|
71128271|NCT00488826|141761874|SUPERIORITY_OR_OTHER||Geometric mean ratio|181.3||||||90.0|119.8|253.1||P-Values were not calculated.|||This analysis is for Serotype 19F.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||253.1|119.8|
71128272|NCT00488826|141761874|SUPERIORITY_OR_OTHER||Geometric mean ratio|90.02||||||90.0|57.93|150.5||P-Values were not calculated.|||This analysis is for Serotype 23F.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||150.5|57.93|
71128273|NCT00488826|141761875|SUPERIORITY_OR_OTHER||Geometric mean ratio|665.1||||||90.0|473.3|851.2||P-Values were not calculated.|||This analysis is for Serotype 4.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||851.2|473.3|
71128274|NCT00488826|141761875|SUPERIORITY_OR_OTHER||Geometric mean ratio|22.2||||||90.0|13.99|31.77||P-Values were not calculated.|||This analysis is for Serotype 6B.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||31.77|13.99|
71128275|NCT00488826|141761875|SUPERIORITY_OR_OTHER||Geometric mean ratio|73.7||||||90.0|56.41|103.6||P-Values were not calculated.|||This analysis is for Serotype 9V.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||103.6|56.41|
71128276|NCT00488826|141761875|SUPERIORITY_OR_OTHER||Geometric mean ratio|99.48||||||90.0|61.09|147.5||P-Values were not calculated.|||This analysis is for Serotype 14.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||147.5|61.09|
71128277|NCT00488826|141761875|SUPERIORITY_OR_OTHER||Geometric mean ratio|164.0||||||90.0|114.9|232.9||P-Values were not calculated.|||This analysis is for Serotype 18C.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||232.9|114.9|
71128278|NCT00488826|141761875|SUPERIORITY_OR_OTHER||Geometric mean ratio|81.45||||||90.0|57.98|119.1||P-Values were not calculated.|||This analysis is for Serotype 19F.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||119.1|57.98|
71128279|NCT00488826|141761875|SUPERIORITY_OR_OTHER||Geometric mean ratio|44.7||||||90.0|29.48|68.71||P-Values were not calculated.|||This analysis is for Serotype 23F.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||68.71|29.48|
71128280|NCT01854281|141761955|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Fisher Exact|||null hypothesis: there is no difference in the occurence of arterial bubbles after simulated dive between closure and PFO groups.||||0.02
71128281|NCT01854281|141761955|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||Fisher Exact|||null hypothesis: there is no difference in the occurence of arterial bubbles after simulated dive between closure and PFO groups.||||<0.01
71128282|NCT03208088|141761956|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.|Least Square Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|2.92|||TWO_SIDED|95.0|0.1|11.6|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test 1 - Control.|||11.6|0.1|
71128283|NCT03208088|141761956|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.|Least Square Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|3.06|||TWO_SIDED|95.0|-4.0|8.1|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test 2 - Control.|||8.1|-4.0|
71128284|NCT03208088|141761957|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.|Least Square Mean difference|-1.5|STANDARD_ERROR_OF_MEAN|3.06|||TWO_SIDED|95.0|-7.5|4.6|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test 3 - Control.|||4.6|-7.5|
70946745|NCT01006616|141393899|SUPERIORITY_OR_OTHER||Difference in percentages|12.2|||<|0.001|TWO_SIDED|95.0|7.4|18.4|||Miettinen and Nurminen||Analysis of Week 26 data|||18.4|7.4|<0.001
70946746|NCT01006616|141393899|SUPERIORITY_OR_OTHER||Difference in percentages|19.7|||<|0.001|TWO_SIDED|95.0|13.8|26.9|||Miettinen and Nurminen||Analysis of Week 26 data|||26.9|13.8|<0.001
71128285|NCT03208088|141761957|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.|Least Square Mean|-3.4|STANDARD_ERROR_OF_MEAN|2.88|||TWO_SIDED|95.0|-9.0|2.3|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test 4 - Control.|||2.3|-9.0|
71128286|NCT00238238|141761963|SUPERIORITY_OR_OTHER|||||||0.29|||||||Fisher Exact|||||||0.29
71128287|NCT00238238|141761964|SUPERIORITY_OR_OTHER|||||||0.002|||||||Log Rank|||||||0.002
71128288|NCT01345669|141761965|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.126||||0.4806|TWO_SIDED|95.0|0.809|1.569|||Log Rank||Hazard ratio (Afatinib vs. Placebo) from Cox proportional hazards model stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|DFS was analysed using a stratified log-rank test with nodal status (N0- N2a vs. N2b-N3) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1) being the stratification factors.||1.569|0.809|0.4806
70858441|NCT02751931|141202991|OTHER|Pre-Specified|Mean Difference (Net)|45.27|||<|0.001|TWO_SIDED|95.0|22.1|68.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||68.4|22.1|<0.001
70858442|NCT02751931|141202991|OTHER||Mean Difference (Net)|42.86||||0.02|TWO_SIDED|95.0|7.4|78.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||78.3|7.4|0.020
71128289|NCT01345669|141761966|SUPERIORITY_OR_OTHER||Difference in Kaplan-Meier estimates|-6.27||||0.161|TWO_SIDED|95.0|-15.04|2.5|||Log Rank||Difference in Kaplan-Meier estimates of Afatinib vs. Placebo is provided.|Kaplan-Meier (KM) curves were calculated for each treatment group, separately, and the estimates of DFS probabilities from the curves and 95% Confidence interval (CI) (using the Greenwood standard error estimate) were tabulated||2.50|-15.04|0.1610
71128290|NCT01345669|141761967|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.444||||0.1301|TWO_SIDED|95.0|0.895|2.332||p-value (two-sided) from log-rank test stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Log Rank|||Hazard ratio from Cox proportional hazards model stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).||2.332|0.895|0.1301
70858443|NCT02751931|141202991|OTHER||Mean Difference (Net)|33.23||||0.003|TWO_SIDED|95.0|12.2|54.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children||54.3|12.2|0.003
70946747|NCT03672175|141393943|SUPERIORITY||Least Square (LS) Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.85||0.6638|TWO_SIDED|95.0|-2.0|1.3||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Mixed effect model for repeated measures (MMRM)||1.3|-2.0|0.6638
71128291|NCT01345669|141761968|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.431||||0.0561|TWO_SIDED|95.0|0.991|2.068|||Regression, Logistic|||Odds ratio and p-value from logistic regression analysis of 'improved vs. not improved' stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3) for Swallowing (Q5-Q8 from QLQ-HN35).||2.068|0.991|0.0561
71128292|NCT01345669|141761968|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.446||||0.0523|TWO_SIDED|95.0|0.996|2.098|||Regression, Logistic|||Odds ratio and p-value from logistic regression analysis of 'improved vs. not improved' stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3) for Pain HN35 (Q1-Q4 from QLQ-HN35).||2.098|0.996|0.0523
71128293|NCT01345669|141761968|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.818||||0.257|TWO_SIDED|95.0|0.577|1.158|||Regression, Logistic|||Odds ratio and p-value from logistic regression analysis of 'improved vs. not improved' stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3) for Global health status/QoL(Q29-Q30 from QLQ-C30).||1.158|0.577|0.2570
71128294|NCT01345669|141761969|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.295||||0.0591|TWO_SIDED|95.0|0.986|1.7||P-value from log-rank test stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Log Rank|||For swallowing scale; Hazard ratio from Cox proportional hazard model stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).||1.700|0.986|0.0591
71128295|NCT01345669|141761969|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.456||||0.0049|TWO_SIDED|95.0|1.113|1.905||P-value from log-rank test stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Log Rank|||For pain HN35 scale; Hazard ratio from Cox proportional hazard model stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).||1.905|1.113|0.0049
70858444|NCT02751931|141202991|OTHER||Mean Difference (Net)|47.29||||0.003|TWO_SIDED|95.0|17.8|76.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||76.8|17.8|0.003
70858445|NCT02751931|141202991|OTHER||Mean Difference (Net)|49.88||||0.004|TWO_SIDED|95.0|17.1|82.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||82.6|17.1|0.004
70858446|NCT02751931|141202991|OTHER||Mean Difference (Net)|84.39||||0.003|TWO_SIDED|95.0|31.6|137.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||137.1|31.6|0.003
70858447|NCT02751931|141202991|OTHER||Mean Difference (Net)|60.09||||0.003|TWO_SIDED|95.0|21.2|99.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||99.0|21.2|0.003
70858448|NCT02751931|141202991|OTHER||Mean Difference (Net)|54.78||||0.017|TWO_SIDED|95.0|10.6|98.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||98.9|10.6|0.017
70858449|NCT02751931|141202991|OTHER||Mean Difference (Net)|53.51||||0.001|TWO_SIDED|95.0|22.6|84.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||84.4|22.6|0.001
70858450|NCT02751931|141202991|OTHER||Mean Difference (Net)|54.3||||0.021|TWO_SIDED|95.0|9.0|99.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||99.6|9.0|0.021
71128296|NCT01345669|141761969|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.604||||0.0002|TWO_SIDED|95.0|1.238|2.079||P-value from log-rank test stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Log Rank|||For global health status/QoL scale; Hazard ratio from Cox proportional hazard model stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).||2.079|1.238|0.0002
71128297|NCT01345669|141761970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|1.08||0.2232|TWO_SIDED|95.0|-0.81|3.45|||Mixed Models Analysis|Degrees of freedom calculated using the Kenward-Roger method.|Afatinib minus Placebo mean adjusted for total with data for baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Scores (swallowing scale) over time were assessed using longitudinal mixed-effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG performance score and nodal status.||3.45|-0.81|0.2232
71128298|NCT01345669|141761970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|1.08||0.0028|TWO_SIDED|95.0|1.12|5.36|||Mixed Models Analysis|Degrees of freedom calculated using the Kenward-Roger method.|Afatinib minus Placebo mean adjusted for total with data for baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Scores (pain scale) over time were assessed using longitudinal mixed-effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG performance score and nodal status.||5.36|1.12|0.0028
70858451|NCT02751931|141202992|OTHER||Mean Difference (Net)|18.13||||0.113|TWO_SIDED|95.0|-4.5|40.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||40.7|-4.5|0.113
70858452|NCT02751931|141202992|OTHER||Mean Difference (Net)|35.58||||0.056|TWO_SIDED|95.0|-1.1|72.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||72.2|-1.1|0.056
70858453|NCT02751931|141202992|OTHER||Mean Difference (Net)|37.71||||0.005|TWO_SIDED|95.0|11.7|63.7|||t-test, 2 sided|From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.||Change From Baseline at Week 4 - Children||63.7|11.7|0.005
70858454|NCT02751931|141202992|OTHER||Mean Difference (Net)|70.35||||0.006|TWO_SIDED|95.0|22.2|118.5||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||118.5|22.2|0.006
70858455|NCT02751931|141202992|OTHER||Mean Difference (Net)|43.91|||<|0.001|TWO_SIDED|95.0|21.0|66.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||66.8|21.0|<0.001
70858456|NCT02751931|141202992|OTHER||Mean Difference (Net)|38.11||||0.063|TWO_SIDED|95.0|-2.2|78.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||78.4|-2.2|0.063
70858457|NCT02751931|141202992|OTHER||Mean Difference (Net)|29.05||||0.008|TWO_SIDED|95.0|8.2|49.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children||49.9|8.2|0.008
70858458|NCT02751931|141202992|OTHER||Mean Difference (Net)|43.04||||0.009|TWO_SIDED|95.0|11.9|74.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||74.2|11.9|0.009
70858459|NCT02751931|141202992|OTHER||Mean Difference (Net)|44.2||||0.006|TWO_SIDED|95.0|13.2|75.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||75.2|13.2|0.006
70858460|NCT02751931|141202992|OTHER||Mean Difference (Net)|81.37||||0.003|TWO_SIDED|95.0|30.4|132.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||132.3|30.4|0.003
70858461|NCT02751931|141202992|OTHER||Mean Difference (Net)|58.49||||0.004|TWO_SIDED|95.0|19.8|97.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||97.2|19.8|0.004
70858462|NCT02751931|141202992|OTHER||Mean Difference (Net)|50.9||||0.039|TWO_SIDED|95.0|2.7|99.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||99.1|2.7|0.039
70858463|NCT02751931|141202992|OTHER||Mean Difference (Net)|53.76||||0.002|TWO_SIDED|95.0|21.7|85.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||85.8|21.7|0.002
70858464|NCT02751931|141202992|OTHER||Mean Difference (Net)|49.13||||0.057|TWO_SIDED|95.0|-1.6|99.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||99.8|-1.6|0.057
70858465|NCT02751931|141202993|OTHER||Mean Difference (Net)|7.98||||0.617|TWO_SIDED|95.0|-24.0|40.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||40.0|-24.0|0.617
71128299|NCT01345669|141761970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|0.98||0.0005|TWO_SIDED|95.0|-5.33|-1.49|||Mixed Models Analysis|Degrees of freedom calculated using the Kenward-Roger method.|Afatinib minus Placebo mean adjusted for total with data for baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Scores (global health/QoL) over time were assessed using longitudinal mixed-effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG performance score and nodal status.||-1.49|-5.33|0.0005
71128300|NCT01793883|141761971|SUPERIORITY|||||||0.251|||||||Log Rank|||||||0.251
71128301|NCT01793883|141761971|SUPERIORITY|||||||0.818|||||||Log Rank|||||||0.818
71128302|NCT02478255|141761972|OTHER|||||||0.22|||||||t-test, 2 sided|||||||0.22
71128303|NCT01431963|141761983|SUPERIORITY_OR_OTHER||percentage of participants|43.1|||||TWO_SIDED|95.0|30.85|55.96|||||The estimated value reflects the percentage of participants who were seizure free for all seizures.|||55.96|30.85|
70858466|NCT02751931|141202993|OTHER||Mean Difference (Net)|39.52||||0.035|TWO_SIDED|95.0|3.0|76.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||76.0|3.0|0.035
70858467|NCT02751931|141202993|OTHER||Mean Difference (Net)|19.81||||0.167|TWO_SIDED|95.0|-8.7|48.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||48.3|-8.7|0.167
71128304|NCT01431963|141761983|SUPERIORITY_OR_OTHER||percentage of participants|40.0|||||TWO_SIDED|95.0|27.02|54.09|||||The estimated value reflects the percentage of participants who were seizure free for A+B+C seizures.|||54.09|27.02|
71128305|NCT01431963|141761983|SUPERIORITY_OR_OTHER||percentage of participants|40.5|||||TWO_SIDED|95.0|25.63|56.72|||||The estimated value reflects the percentage of participants who were seizure free for A+B seizures.|||56.72|25.63|
71128306|NCT01431963|141761983|SUPERIORITY_OR_OTHER||percentage of participants|69.7|||||TWO_SIDED|95.0|51.29|84.41|||||The estimated value reflects the percentage of participants who were seizure free for C seizures.|||84.41|51.29|
71128307|NCT01431963|141761983|SUPERIORITY_OR_OTHER||percentage of participants|80.0|||||TWO_SIDED|95.0|44.39|97.48|||||The estimated value reflects the percentage of participants who were seizure free for D5 seizures.|||97.48|44.39|
71128308|NCT01769196|141762031|SUPERIORITY|The null hypothesis was that there is no difference in PFS between simtuzumab and simtuzumab placebo. The alternative hypothesis was that there is a difference. These hypotheses were evaluated using stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted, sLOXL2 level categories and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.|Hazard Ratio (HR)|1.13||||0.329|TWO_SIDED|95.0|0.88|1.45|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted, sLOXL2 level categories, and concomitant pirfenidone/nintedanib use at time of screening.|||1.45|0.88|0.329
71128309|NCT01769196|141762032|SUPERIORITY|The null hypothesis was that there is no difference in PFS between simtuzumab and simtuzumab placebo in participants with sLOXL2 ≥ 50th percentile. The alternative hypothesis was that there is a difference. These hypotheses were evaluated using stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.|Hazard Ratio (HR)|1.03||||0.851|TWO_SIDED|95.0|0.74|1.43|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted and concomitant pirfenidone/nintedanib use at time of screening.|||1.43|0.74|0.851
71128310|NCT01769196|141762033|SUPERIORITY|The null hypothesis was that there is no difference in PFS between simtuzumab and simtuzumab placebo in participants with sLOXL2 ≥ 75th percentile. The alternative hypothesis was that there is a difference. These hypotheses were evaluated using stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.|Hazard Ratio (HR)|1.2||||0.475|TWO_SIDED|95.0|0.72|2.0|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted and concomitant pirfenidone/nintedanib use at time of screening.|||2.00|0.72|0.475
71128311|NCT01769196|141762034|OTHER||Hazard Ratio (HR)|1.2||||0.602|TWO_SIDED|95.0|0.61|2.37|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted, sLOXL2 level categories, and concomitant pirfenidone/nintedanib use at time of screening.|||2.37|0.61|0.602
70858468|NCT02751931|141202993|OTHER||Mean Difference (Net)|75.25||||0.005|TWO_SIDED|95.0|25.8|124.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||124.7|25.8|0.005
70858469|NCT02751931|141202993|OTHER||Mean Difference (Net)|34.01||||0.02|TWO_SIDED|95.0|5.7|62.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||62.3|5.7|0.020
71128312|NCT01769196|141762035|OTHER|The difference in OS between the treatment groups was assessed using the stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.|Hazard Ratio (HR)|0.99||||0.988|TWO_SIDED|95.0|0.43|2.28|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted and concomitant pirfenidone/nintedanib use at time of screening.|||2.28|0.43|0.988
71128313|NCT01769196|141762036|OTHER|The difference in OS between the treatment groups was assessed using the stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.|Hazard Ratio (HR)|0.95||||0.925|TWO_SIDED|95.0|0.3|2.99|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted and concomitant pirfenidone/nintedanib use at time of screening.|||2.99|0.30|0.925
71128314|NCT00655629|141762047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.92|||<|0.0001||95.0|-8.45|-5.38|||ANCOVA|||Power adjustment for 3 primary efficacy variables (3 variables have to be significant in favor of Vardenafil to conclude efficacy). Statistical analysis applies to the total population.||-5.38|-8.45|<0.0001
71128315|NCT00655629|141762048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.972|||<|0.0001||95.0|-32.688|-19.256|||ANCOVA|||Statistical analysis applies to the total population.||-19.256|-32.688|<0.0001
71128316|NCT00655629|141762049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.432|||<|0.0001||95.0|-40.439|-26.425|||ANCOVA|||Statistical analysis applies to the total population.||-26.425|-40.439|<0.0001
71128317|NCT00655629|141762050|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel|53.8693|||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|CMH adjusted for age group and center||Statistical analysis applies to the total population.||||<0.0001
71128318|NCT00655629|141762051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.078|||<|0.0001||95.0|-22.41|-9.746|||ANCOVA|||Statistical analysis applies to the total population.||-9.746|-22.41|<0.0001
71128319|NCT00655629|141762052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.134|||<|0.0001||95.0|-40.281|-25.987|||ANCOVA|||Statistical analysis applies to the total population.||-25.987|-40.281|<0.0001
71128320|NCT00655629|141762053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.934|||<|0.0001||95.0|-41.119|-26.749|||ANCOVA|||Statistical analysis applies to the total population.||-26.749|-41.119|<0.0001
71128321|NCT00655629|141762054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.902|||<|0.0001||95.0|-27.724|-14.081|||ANCOVA|||Statistical analysis applies to the total population.||-14.081|-27.724|<0.0001
71128322|NCT00655629|141762056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.866|||<|0.0001||95.0|-22.599|-11.133|||ANCOVA|||Statistical analysis applies to the total population.||-11.133|-22.599|<0.0001
71128323|NCT00655629|141762057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.04|||<|0.0001||95.0|-31.547|-20.533|||ANCOVA|||Statistical analysis applies to the total population.||-20.533|-31.547|<0.0001
70858470|NCT02751931|141202993|OTHER||Mean Difference (Net)|44.43||||0.033|TWO_SIDED|95.0|3.9|84.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||84.9|3.9|0.033
70858471|NCT02751931|141202993|OTHER||Mean Difference (Net)|8.68||||0.503|TWO_SIDED|95.0|-17.3|34.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0|t-test, 2 sided|||Change From Baseline at Week 12 - Children||34.7|-17.3|0.503
71128324|NCT00655629|141762058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.496|||<|0.0001||95.0|-24.676|-14.315|||ANCOVA|||Statistical analysis applies to the total population.||-14.315|-24.676|<0.0001
71128325|NCT00655629|141762059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.418|||<|0.0001||95.0|-24.439|-12.396|||ANCOVA|||Statistical analysis applies to the total population.||-12.396|-24.439|<0.0001
71128326|NCT00655629|141762060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.379|||<|0.0001||95.0|-28.006|-16.753|||ANCOVA|||Statistical analysis applies to the total population.||-16.753|-28.006|<0.0001
71128327|NCT00655629|141762061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.758|||<|0.0001||95.0|-36.736|-24.779|||ANOVA|||Statistical analysis applies to the total population.||-24.779|-36.736|<0.0001
71128328|NCT00655629|141762062|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel|60.2391|||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|CMH adjusted for age group and center||Statistical analysis applies to the total population.||||<0.0001
70858472|NCT02751931|141202993|OTHER||Mean Difference (Net)|38.23||||0.016|TWO_SIDED|95.0|7.8|68.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||68.6|7.8|0.016
71128329|NCT00741013|141762098|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Only a single statistical analysis was performed upon completion of the study.|ANOVA|||One-way analysis of variance was performed to determine whether lovastatin or rhAPC effectively reduced endotoxin-induced lung inflammation.||||<0.05
71128330|NCT00921843|141762110|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71128331|NCT02870101|141762111|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|94.7|||||TWO_SIDED|95.0|90.7|97.0|||||PPA estimated with two-sided 95% score confidence interval.|||97.0|90.7|
71128332|NCT02870101|141762111|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|98.8|||||TWO_SIDED|95.0|98.2|99.1|||||NPA estimated with two-sided 95% score confidence interval.|||99.1|98.2|
71128333|NCT02870101|141762112|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|91.2|||||TWO_SIDED|95.0|86.5|94.4|||||PPA estimated with two-sided 95% score confidence interval.|||94.4|86.5|
71128334|NCT02870101|141762112|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.6|||||TWO_SIDED|95.0|99.3|99.8|||||NPA estimated with two-sided 95% score confidence interval.|||99.8|99.3|
71128335|NCT02870101|141762113|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)|PPA|95.1|||||TWO_SIDED|95.0|91.3|97.3|||||PPA estimated with two-sided 95% score confidence interval.|||97.3|91.3|
71128336|NCT02870101|141762113|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|98.8|||||TWO_SIDED|95.0|98.3|99.2|||||NPA estimated with two-sided 95% score confidence interval.|||99.2|98.3|
71128337|NCT02870101|141762114|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|96.5|||||TWO_SIDED|95.0|92.9|98.3|||||PPA estimated with two-sided 95% score confidence interval.|||98.3|92.9|
71128338|NCT02870101|141762114|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.2|||||TWO_SIDED|95.0|98.8|99.5|||||NPA estimated with two-sided 95% score confidence interval.|||99.5|98.8|
71128339|NCT02870101|141762115|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|84.8|||||TWO_SIDED|95.0|79.4|89.0|||||PPA estimated with two-sided 95% score confidence interval.|||89.0|79.4|
71128340|NCT02870101|141762115|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.5|||||TWO_SIDED|95.0|99.2|99.7|||||NPA estimated with two-sided 95% score confidence interval.|||99.7|99.2|
71128341|NCT02870101|141762116|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|88.3|||||TWO_SIDED|95.0|83.2|92.0|||||PPA estimated with two-sided 95% score confidence interval.|||92.0|83.2|
71128342|NCT02870101|141762116|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.6|||||TWO_SIDED|95.0|99.2|99.8|||||NPA estimated with two-sided 95% score confidence interval.|||99.8|99.2|
71128343|NCT02870101|141762117|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|95.9|||||TWO_SIDED|95.0|86.3|98.9|||||PPA estimated with two-sided 95% score confidence interval.|||98.9|86.3|
71128344|NCT02870101|141762117|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.7|||||TWO_SIDED|95.0|99.4|99.8|||||NPA estimated with two-sided 95% score confidence interval.|||99.8|99.4|
71128345|NCT02870101|141762118|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|86.0|||||TWO_SIDED|95.0|80.9|89.9|||||PPA estimated with two-sided 95% score confidence interval.|||89.9|80.9|
71128346|NCT02870101|141762118|OTHER|Estimated Negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.3|||||TWO_SIDED|95.0|98.9|99.6|||||NPA estimated with two-sided 95% score confidence interval.|||99.6|98.9|
71128347|NCT02870101|141762119|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)|PPA|88.2|||||TWO_SIDED|95.0|76.6|94.5|||||PPA estimated with two-sided 95% score confidence interval.|||94.5|76.6|
71128348|NCT02870101|141762119|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.7|||||TWO_SIDED|95.0|99.4|99.8|||||NPA estimated with two-sided 95% score confidence interval.|||99.8|99.4|
71128349|NCT02870101|141762120|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)|PPA|88.7|||||TWO_SIDED|95.0|83.9|92.3|||||PPA estimated with two-sided 95% score confidence interval.|||92.3|83.9|
71128350|NCT02870101|141762120|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|98.7|||||TWO_SIDED|95.0|98.2|99.1|||||NPA estimated with two-sided 95% score confidence interval.|||99.1|98.2|
71128351|NCT02870101|141762121|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)|PPA|84.0|||||TWO_SIDED|95.0|71.5|91.7|||||PPA estimated with two-sided 95% score confidence interval.|||91.7|71.5|
70858473|NCT02751931|141202993|OTHER||Mean Difference (Net)|40.76||||0.043|TWO_SIDED|95.0|1.4|80.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||80.2|1.4|0.043
70858474|NCT02751931|141202993|OTHER||Mean Difference (Net)|86.66|||<|0.001|TWO_SIDED|95.0|41.5|131.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||131.8|41.5|<0.001
70946748|NCT03672175|141393943|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.89||0.1158|TWO_SIDED|95.0|-3.1|0.3||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||||0.3|-3.1|0.1158
71128352|NCT02870101|141762121|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.8|||||TWO_SIDED|95.0|99.5|99.9|||||NPA estimated with two-sided 95% score confidence interval.|||99.9|99.5|
71128353|NCT02870101|141762122|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)|PPA|83.0|||||TWO_SIDED|95.0|77.6|87.3|||||PPA estimated with two-sided 95% score confidence interval.|||87.3|77.6|
70858475|NCT02751931|141202993|OTHER||Mean Difference (Net)|31.08||||0.203|TWO_SIDED|95.0|-17.5|79.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||79.6|-17.5|0.203
71128354|NCT02870101|141762122|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.1|||||TWO_SIDED|95.0|98.6|99.4|||||NPA estimated with two-sided 95% score confidence interval.|||99.4|98.6|
71128355|NCT01059994|141762124|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||||||0.02
71128356|NCT01059994|141762125|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||||||0.004
70946749|NCT03672175|141393944|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.6905|TWO_SIDED|95.0|-0.4|0.2||MMRM was used for the analysis. Treatment, BL CGI-S score, BL antidepressant use, assessment time point, and time point-by-treatment interaction were included in the model and were treated as fixed effects.|MMRM|||||0.2|-0.4|0.6905
70946750|NCT03672175|141393944|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.1082|TWO_SIDED|95.0|-0.5|0.1||MMRM was used for the analysis. Treatment, BL CGI-S score, BL antidepressant use, assessment time point, and time point-by-treatment interaction were included in the model and were treated as fixed effects.|MMRM|||||0.1|-0.5|0.1082
70946751|NCT03672175|141393945|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.65||0.5725|TWO_SIDED|95.0|-1.7|0.9||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 3||0.9|-1.7|0.5725
70946752|NCT03672175|141393945|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.64||0.016|TWO_SIDED|95.0|-2.8|-0.3||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 3||-0.3|-2.8|0.0160
71128357|NCT00098306|141762146|SUPERIORITY_OR_OTHER||LS mean difference|-0.788|STANDARD_ERROR_OF_MEAN|0.1571|||TWO_SIDED|97.5|-1.141|-0.435||||||The difference between the treatment least square means (LS means) adjusted for the randomization strata was presented in addition to 2-sided 97.5% confidence interval (CI) as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.435|-1.141|
71128358|NCT00098306|141762146|SUPERIORITY_OR_OTHER||LS mean difference|-0.922|STANDARD_ERROR_OF_MEAN|0.1568|||TWO_SIDED|97.5|-1.275|-0.57||||||The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.570|-1.275|
71128359|NCT00098306|141762147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.88|||<|0.0001|TWO_SIDED|95.0|1.78|4.67|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (less than \[\<\] 100,000 or greater than or equal to \[\>=\] 100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio greater than (\>) 1 favors maraviroc.||4.67|1.78|<0.0001
71128360|NCT00098306|141762147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.66|||<|0.0001|TWO_SIDED|95.0|2.26|5.95|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||5.95|2.26|<0.0001
71128361|NCT00098306|141762147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.96|||<|0.0001|TWO_SIDED|95.0|2.36|6.64|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||6.64|2.36|<0.0001
70946753|NCT03672175|141393945|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.75||0.445|TWO_SIDED|95.0|-2.1|0.9||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 8||0.9|-2.1|0.4450
70946754|NCT03672175|141393945|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.79||0.0081|TWO_SIDED|95.0|-3.6|-0.5||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 8||-0.5|-3.6|0.0081
71128362|NCT00098306|141762147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.11|||<|0.0001|TWO_SIDED|95.0|3.04|8.59|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||8.59|3.04|<0.0001
71128363|NCT00098306|141762148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.6|||<|0.0001|TWO_SIDED|95.0|1.63|4.13|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||4.13|1.63|<0.0001
71128364|NCT00098306|141762148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.85|||<|0.0001|TWO_SIDED|95.0|1.79|4.54|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||4.54|1.79|<0.0001
71128365|NCT00098306|141762148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.93|||<|0.0001|TWO_SIDED|95.0|1.83|4.67|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||4.67|1.83|<0.0001
71128366|NCT00098306|141762148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.33|||<|0.0001|TWO_SIDED|95.0|2.08|5.32|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||5.32|2.08|<0.0001
71128367|NCT00098306|141762149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.06|||<|0.0001|TWO_SIDED|95.0|1.92|4.88|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||4.88|1.92|<0.0001
71128368|NCT00098306|141762149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.55|||<|0.0001|TWO_SIDED|95.0|2.22|5.68|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||5.68|2.22|<0.0001
71128369|NCT00098306|141762149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.3|||<|0.0001|TWO_SIDED|95.0|2.05|5.31|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||5.31|2.05|<0.0001
71128370|NCT00098306|141762149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.03|||<|0.0001|TWO_SIDED|95.0|2.5|6.51|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||6.51|2.50|<0.0001
71128371|NCT00098306|141762150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.43||||0.0006|TWO_SIDED|95.0|1.46|4.04|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||4.04|1.46|0.0006
71128372|NCT00098306|141762150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.15|||<|0.0001|TWO_SIDED|95.0|1.9|5.23|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||5.23|1.90|<0.0001
71128373|NCT00098306|141762150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1|||<|0.0001|TWO_SIDED|95.0|2.32|7.25|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.25|2.32|<0.0001
71128374|NCT00098306|141762150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.97|||<|0.0001|TWO_SIDED|95.0|2.82|8.77|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||8.77|2.82|<0.0001
71128375|NCT00098306|141762152|SUPERIORITY_OR_OTHER||LS mean difference|54.49|STANDARD_ERROR_OF_MEAN|12.435|||TWO_SIDED|95.0|30.07|78.92||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||78.92|30.07|
71128376|NCT00098306|141762152|SUPERIORITY_OR_OTHER||LS mean difference|58.94|STANDARD_ERROR_OF_MEAN|12.378|||TWO_SIDED|95.0|34.63|83.26||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||83.26|34.63|
71128377|NCT00098306|141762152|SUPERIORITY_OR_OTHER||LS mean difference|58.56|STANDARD_ERROR_OF_MEAN|12.677|||TWO_SIDED|95.0|33.66|83.46||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||83.46|33.66|
71128378|NCT00098306|141762152|SUPERIORITY_OR_OTHER||LS mean difference|68.47|STANDARD_ERROR_OF_MEAN|12.617|||TWO_SIDED|95.0|43.69|93.25||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||93.25|43.69|
71128379|NCT00098306|141762153|SUPERIORITY_OR_OTHER||LS mean difference|284.21|STANDARD_ERROR_OF_MEAN|51.779|||TWO_SIDED|95.0|182.51|385.92||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||385.92|182.51|
71128380|NCT00098306|141762153|SUPERIORITY_OR_OTHER||LS mean difference|303.07|STANDARD_ERROR_OF_MEAN|51.507|||TWO_SIDED|95.0|201.9|404.23||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||404.23|201.90|
71128381|NCT00098306|141762153|SUPERIORITY_OR_OTHER||LS mean difference|213.34|STANDARD_ERROR_OF_MEAN|49.679|||TWO_SIDED|95.0|115.77|310.92||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||310.92|115.77|
71128382|NCT00098306|141762153|SUPERIORITY_OR_OTHER||LS mean difference|235.74|STANDARD_ERROR_OF_MEAN|49.416|||TWO_SIDED|95.0|138.68|332.8||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||332.80|138.68|
71128383|NCT00098306|141762154|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.34|0.6|||Log Rank|||P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio calculated by fitting a Cox proportional hazards model including treatment group and randomization strata. Hazard ratio \<1 favors maraviroc.||0.60|0.34|<0.0001
70858476|NCT02751931|141202993|OTHER||Mean Difference (Net)|68.47||||0.019|TWO_SIDED|95.0|12.7|124.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||124.2|12.7|0.019
70858477|NCT02751931|141202993|OTHER||Mean Difference (Net)|31.83||||0.042|TWO_SIDED|95.0|1.3|62.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||62.4|1.3|0.042
70858478|NCT02751931|141202993|OTHER||Mean Difference (Net)|38.14||||0.121|TWO_SIDED|95.0|-11.0|87.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||87.3|-11.0|0.121
70858479|NCT02751931|141202994|OTHER||Mean Difference (Net)|0.35||||0.818|TWO_SIDED|95.0|-2.7|3.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||3.4|-2.7|0.818
70858480|NCT02751931|141202994|OTHER||Mean Difference (Net)|-0.53||||0.114|TWO_SIDED|95.0|-1.2|0.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||0.1|-1.2|0.114
70858481|NCT02751931|141202994|OTHER||Mean Difference (Net)|-1.14||||0.052|TWO_SIDED|95.0|-2.3|0.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||0.0|-2.3|0.052
70858482|NCT02751931|141202994|OTHER||Mean Difference (Net)|-0.87||||0.066|TWO_SIDED|95.0|-1.8|0.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||0.1|-1.8|0.066
70858483|NCT02751931|141202994|OTHER||Mean Difference (Net)|1.16||||0.674|TWO_SIDED|95.0|-4.4|6.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||6.7|-4.4|0.674
70858484|NCT02751931|141202994|OTHER||Mean Difference (Net)|-0.65||||0.278|TWO_SIDED|95.0|-1.9|0.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||0.6|-1.9|0.278
70858485|NCT02751931|141202994|OTHER||Mean Difference (Net)|0.37||||0.871|TWO_SIDED|95.0|-4.2|5.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children||5.0|-4.2|0.871
70858486|NCT02751931|141202994|OTHER||Mean Difference (Net)|-0.65||||0.153|TWO_SIDED|95.0|-1.6|0.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||0.3|-1.6|0.153
70946755|NCT03672175|141393945|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.95||0.8219|TWO_SIDED|95.0|-1.6|2.1||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 42||2.1|-1.6|0.8219
70858487|NCT02751931|141202994|OTHER||Mean Difference (Net)|0.18||||0.922|TWO_SIDED|95.0|-3.5|3.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||3.9|-3.5|0.922
70858488|NCT02751931|141202994|OTHER||Mean Difference (Net)|-0.75||||0.047|TWO_SIDED|95.0|-1.5|0.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||0.0|-1.5|0.047
70858489|NCT02751931|141202994|OTHER||Mean Difference (Net)|-1.98||||0.018|TWO_SIDED|95.0|-3.6|-0.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||-0.4|-3.6|0.018
70858490|NCT02751931|141202994|OTHER||Mean Difference (Net)|-0.81||||0.07|TWO_SIDED|95.0|-1.7|0.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||0.1|-1.7|0.070
70946756|NCT03672175|141393945|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.92||0.8166|TWO_SIDED|95.0|-2.0|1.6||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 42||1.6|-2.0|0.8166
71128384|NCT00098306|141762154|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.38|||<|0.0001|TWO_SIDED|95.0|0.28|0.5|||Log Rank|||P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio calculated by fitting a Cox proportional hazards model including treatment group and randomization strata. Hazard ratio \<1 favors maraviroc.||0.50|0.28|<0.0001
71128385|NCT00098306|141762155|SUPERIORITY_OR_OTHER||LS mean difference|-0.697|STANDARD_ERROR_OF_MEAN|0.1347|||TWO_SIDED|95.0|-0.961|-0.432||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.432|-0.961|
71128386|NCT00098306|141762155|SUPERIORITY_OR_OTHER||LS mean difference|-0.802|STANDARD_ERROR_OF_MEAN|0.1344|||TWO_SIDED|95.0|-1.065|-0.538||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.538|-1.065|
71128387|NCT00098306|141762155|SUPERIORITY_OR_OTHER||LS mean difference|-0.767|STANDARD_ERROR_OF_MEAN|0.1497|||TWO_SIDED|95.0|-1.061|-0.474||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.474|-1.061|
71128388|NCT00098306|141762155|SUPERIORITY_OR_OTHER||LS mean difference|-0.931|STANDARD_ERROR_OF_MEAN|0.1494|||TWO_SIDED|95.0|-1.225|-0.638||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.638|-1.225|
71128389|NCT00098306|141762156|SUPERIORITY_OR_OTHER||LS mean difference|-0.853|STANDARD_ERROR_OF_MEAN|0.1621|||TWO_SIDED|97.5|-1.217|-0.489||||||The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.489|-1.217|
71128390|NCT00098306|141762156|SUPERIORITY_OR_OTHER||LS mean difference|-1.021|STANDARD_ERROR_OF_MEAN|0.1618|||TWO_SIDED|97.5|-1.385|-0.658||||||The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.658|-1.385|
71128391|NCT01336023|141762172|NON_INFERIORITY|"Non-inferiority of IDegLira vs. IDeg was confirmed when 95% confidence interval for the treatment differences for change in HbA1c lies entirely below 0.3%.~IDegLira minus IDeg"|Treatment Contrast|-0.47|||||TWO_SIDED|95.0|-0.58|-0.36|||ANCOVA||IDegLira minus IDeg|||-0.36|-0.58|
71128392|NCT01336023|141762172|SUPERIORITY|"Superiority of IDegLira over liraglutide was confirmed when the 95% confidence interval for the treatment difference for change in HbA1c lies entirely below 0%.~IDegLira minus Liraglutide"|Treatment contrast|-0.64|||||TWO_SIDED|95.0|-0.75|-0.53|||ANCOVA||IDegLira minus Liraglutide|||-0.53|-0.75|
71128393|NCT01122849|141762181|SUPERIORITY_OR_OTHER||Least Square (LS) Mean difference|-0.12||||0.5456|TWO_SIDED|95.0|-0.52|0.28||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q1 at Day 7||0.28|-0.52|0.5456
71128394|NCT01122849|141762181|SUPERIORITY_OR_OTHER||LS mean difference|-0.34||||0.1029|TWO_SIDED|95.0|-0.75|0.07||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q1 at Day 7||0.07|-0.75|0.1029
71128395|NCT01122849|141762181|SUPERIORITY_OR_OTHER||LS mean difference|0.22||||0.2879|TWO_SIDED|95.0|-0.19|0.62||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q1 at Day 7||0.62|-0.19|0.2879
71128396|NCT01122849|141762181|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.8213|TWO_SIDED|95.0|-0.45|0.56||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q3 at Day 7||0.56|-0.45|0.8213
71128397|NCT01122849|141762181|SUPERIORITY_OR_OTHER||LS Mean difference|-0.24||||0.3457||95.0|-0.74|0.27||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q3 at Day 7||0.27|-0.74|0.3457
71128398|NCT01122849|141762181|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.2364|TWO_SIDED|95.0|-0.2|0.79|||ANCOVA|||Comparison for Q3 at Day 7||0.79|-0.20|0.2364
71128399|NCT01122849|141762181|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.3553|TWO_SIDED|95.0|-0.21|0.57||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q17 at Day 7||0.57|-0.21|0.3553
71128400|NCT01122849|141762181|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.3369|TWO_SIDED|95.0|-0.58|0.2||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q17 at Day 7||0.20|-0.58|0.3369
71128401|NCT01122849|141762181|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.0591|TWO_SIDED|95.0|-0.01|0.76||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q17 at Day 7||0.76|-0.01|0.0591
71128402|NCT01122849|141762181|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05||||0.7686|TWO_SIDED|95.0|-0.42|0.31||Between treatment p-values and confidence intervals.|ANCOVA|||Comparison of Q18 at Day 7||0.31|-0.42|0.7686
71128403|NCT01122849|141762181|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.46||||0.0151|TWO_SIDED|95.0|-0.83|-0.09|||ANCOVA|||Comparison of Q18 at Day 7||-0.09|-0.83|0.0151
71128404|NCT01122849|141762181|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41||||0.0256|TWO_SIDED|95.0|0.05|0.77||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q18 at Day 7||0.77|0.05|0.0256
71128405|NCT01122849|141762182|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11||||0.5958|TWO_SIDED|95.0|-0.52|0.3||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q1at Day 14||0.30|-0.52|0.5958
71128406|NCT01122849|141762182|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31||||0.1429|TWO_SIDED|95.0|-0.73|0.11||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q1 at Day 14||0.11|-0.73|0.1429
71128407|NCT01122849|141762182|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.3348|TWO_SIDED|95.0|-0.21|0.62|||ANCOVA|||Comparison of Q1 at Day 14||0.62|-0.21|0.3348
71128408|NCT01122849|141762182|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.4425||95.0|-0.32|0.72||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q3 at Day 14||0.72|-0.32|0.4425
71128409|NCT01122849|141762182|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.4795|TWO_SIDED|95.0|-0.71|0.34|||ANCOVA|||Comparison of Q3 at Day 14||0.34|-0.71|0.4795
71128410|NCT01122849|141762182|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39||||0.1375|TWO_SIDED|95.0|-0.13|0.9||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q3 at Day 14||0.90|-0.13|0.1375
71128411|NCT01122849|141762182|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.12||||0.575|TWO_SIDED|95.0|-0.56|0.31||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q17 at Day 14||0.31|-0.56|0.5750
71128412|NCT01122849|141762182|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48||||0.0337|TWO_SIDED|95.0|-0.92|-0.04||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q17 at Day 14||-0.04|-0.92|0.0337
71128413|NCT01122849|141762182|SUPERIORITY_OR_OTHER||LS Mean Difference|0.35||||0.1061|TWO_SIDED|95.0|-0.08|0.79||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q17 at Day 14||0.79|-0.08|0.1061
71128414|NCT01122849|141762182|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.7092|TWO_SIDED|95.0|-0.5|0.34||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q18 at Day 14||0.34|-0.50|0.7092
71128415|NCT01122849|141762182|SUPERIORITY_OR_OTHER||LS Mean difference|-0.49||||0.025|TWO_SIDED|95.0|-0.91|-0.06||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q18 at Day14||-0.06|-0.91|0.0250
71128416|NCT01122849|141762182|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41||||0.0503|TWO_SIDED|95.0|0.0|0.82||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q18 at Day 14||0.82|0.00|0.0503
71128417|NCT01122849|141762183|SUPERIORITY_OR_OTHER||LS Mean Difference|0.84||||0.5462|TWO_SIDED|95.0|-1.92|3.59||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for sleep problems at Day 7||3.59|-1.92|0.5462
71128418|NCT01122849|141762183|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.37||||0.0942|TWO_SIDED|95.0|-5.16|0.42||Between treatment p-values and confidence intervals.|ANCOVA|||Comparison for sleep problems at Day 7||0.42|-5.16|0.0942
71128419|NCT01122849|141762183|SUPERIORITY_OR_OTHER||LS Mean Difference|3.2||||0.0221|TWO_SIDED|95.0|0.48|5.93||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of sleep problems at Day 7||5.93|0.48|0.0221
71128420|NCT01122849|141762183|SUPERIORITY_OR_OTHER||LS Mean difference|-0.72||||0.6731|TWO_SIDED|95.0|-4.11|2.68||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Sleep Time problems at Day 7||2.68|-4.11|0.6731
71128421|NCT01122849|141762183|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.57||||0.1354|TWO_SIDED|95.0|-5.98|0.83||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Sleep time problems at Day 7||0.83|-5.98|0.1354
71128422|NCT01122849|141762183|SUPERIORITY_OR_OTHER||LS Mean difference|1.86||||0.2722|TWO_SIDED|95.0|-1.5|5.21||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of sleep time problems at Day 7||5.21|-1.50|0.2722
71128423|NCT01122849|141762183|SUPERIORITY_OR_OTHER||LS Mean difference|-0.71||||0.6195|TWO_SIDED|95.0|-3.55|2.14||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for symptoms on walking in the morning at Day 7||2.14|-3.55|0.6195
71128424|NCT01122849|141762183|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.83||||0.0099|TWO_SIDED|95.0|-6.7|-0.96||Between treatment p-values and confidence intervals|ANCOVA|||Comparison at day 7 for symptoms for walking in the morning||-0.96|-6.70|0.0099
71128425|NCT01122849|141762183|SUPERIORITY_OR_OTHER||LS Mean Difference|3.12||||0.0298|TWO_SIDED|95.0|0.32|5.93||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for symptoms on waking in the morning at Day 7||5.93|0.32|0.0298
71128426|NCT01122849|141762183|SUPERIORITY_OR_OTHER||LS Mean difference|-0.3||||0.7211|TWO_SIDED|95.0|-2.01|1.4||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day 7||1.40|-2.01|0.7211
71128427|NCT01122849|141762183|SUPERIORITY_OR_OTHER||LS Mean difference|-0.8||||0.35|TWO_SIDED|95.0|-2.51|0.9||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day 7||0.90|-2.51|0.3500
71128428|NCT01122849|141762183|SUPERIORITY_OR_OTHER||LS Mean difference|0.5||||0.5564|TWO_SIDED|95.0|-1.19|2.18||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day 7||2.18|-1.19|0.5564
71128429|NCT01122849|141762184|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.6804|TWO_SIDED|95.0|-2.2|3.35||Between treatment p-values and confidence intervals.|ANCOVA|||Comparison for Sleep Problems at Day 14||3.35|-2.20|0.6804
71128430|NCT01122849|141762184|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.31||||0.3524|TWO_SIDED|95.0|-4.12|1.49||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for sleep problems at Day 14||1.49|-4.12|0.3524
71128431|NCT01122849|141762184|SUPERIORITY_OR_OTHER||LS Mean Difference|1.89||||0.1739|TWO_SIDED|95.0|-0.86|4.63||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for sleep problems at Day 14||4.63|-0.86|0.1739
71128432|NCT01122849|141762184|SUPERIORITY_OR_OTHER||LS Mean difference|1.98||||0.2463|TWO_SIDED|95.0|-1.41|5.36||Between treatment p-values and confidence intervals|ANCOVA|Between treatment p-values and confidence intervals||Comparison for Sleep time problems at Day 14||5.36|-1.41|0.2463
71128433|NCT01122849|141762184|SUPERIORITY_OR_OTHER||LS Mean difference|0.28||||0.8677|TWO_SIDED|95.0|-3.11|3.68|||ANCOVA|||Comparison for sleep time problems at Day 14||3.68|-3.11|0.8677
71128434|NCT01122849|141762184|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.3136|TWO_SIDED|95.0|-1.65|5.04||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for sleep time problems at Day 14||5.04|-1.65|0.3136
71128435|NCT01122849|141762184|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14||||0.9183|TWO_SIDED|95.0|-2.93|2.65||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for symptoms on waking in the morning at Day 14||2.65|-2.93|0.9183
71128436|NCT01122849|141762184|SUPERIORITY_OR_OTHER||LS Mean difference|-2.68||||0.0614|TWO_SIDED|95.0|-5.5|0.13||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for symptoms on waking in the morning at Day 14||0.13|-5.50|0.0614
71128437|NCT01122849|141762184|SUPERIORITY_OR_OTHER||LS Mean Difference|2.54||||0.0695|TWO_SIDED|95.0|-0.21|5.29||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for symptoms on waking in the morning at Day 14||5.29|-0.21|0.0695
71128438|NCT01122849|141762184|SUPERIORITY_OR_OTHER||LS Mean difference|0.54||||0.4947|TWO_SIDED|95.0|-1.03|2.1||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day14||2.10|-1.03|0.4947
71128439|NCT01122849|141762184|SUPERIORITY_OR_OTHER||LS Mean difference|0.15||||0.8454|TWO_SIDED|95.0|-1.42|1.72||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day 14||1.72|-1.42|0.8454
71128440|NCT01122849|141762184|SUPERIORITY_OR_OTHER||LS Mean difference|0.38||||0.6223|TWO_SIDED|95.0|-1.17|1.93||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day 14||1.93|-1.17|0.6223
71128441|NCT01122849|141762185|SUPERIORITY_OR_OTHER||LS Mean difference|-1.34||||0.4258|TWO_SIDED|95.0|-4.68|2.01||Between treatment p-values and confidence intervals|LS Mean Difference|||Comparison at Day 7||2.01|-4.68|0.4258
71128442|NCT01122849|141762185|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.05||||0.0764|TWO_SIDED|95.0|-6.43|0.33||Between treatment p-values and confidence intervals|ANCOVA|||Comparison at Day 7||0.33|-6.43|0.0764
71128443|NCT01122849|141762185|SUPERIORITY_OR_OTHER||LS Mean Difference|1.71||||0.2986|TWO_SIDED|95.0|-1.56|4.97||Between treatment p-values and confidence intervals|ANCOVA|||Comparison at Day 7||4.97|-1.56|0.2986
71128444|NCT01122849|141762186|SUPERIORITY_OR_OTHER||LS Mean Difference|1.12||||0.482|TWO_SIDED|95.0|-2.05|4.29||Between treatment p-values and confidence intervals|ANCOVA|||||4.29|-2.05|0.4820
71128445|NCT01122849|141762186|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.81||||0.2607|TWO_SIDED|95.0|-5.02|1.39||Between treatment p-values and confidence intervals|ANCOVA|||||1.39|-5.02|0.2607
71128446|NCT01122849|141762186|SUPERIORITY_OR_OTHER||LS Mean Difference|2.93||||0.0623|TWO_SIDED|95.0|-0.16|6.02||Between treatment p-values and confidence intervals|ANCOVA|||||6.02|-0.16|0.0623
71128447|NCT01122849|141762187|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.36||||0.5278|TWO_SIDED|95.0|-18.1|9.39||Between treatment p-values and confidence intervals|ANCOVA|||||9.39|-18.1|0.5278
71128448|NCT01122849|141762187|SUPERIORITY_OR_OTHER||LS Mean Difference|10.14||||0.1458|TWO_SIDED|95.0|-3.64|23.93||Between treatment p-values and confidence intervals|ANCOVA|||||23.93|-3.64|0.1458
71128449|NCT01122849|141762187|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.5||||0.037|TWO_SIDED|95.0|-28.1|-0.91||Between treatment p-values and confidence intervals.|ANCOVA|||||-0.91|-28.1|0.0370
71128450|NCT01122849|141762188|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.1||||0.4483|TWO_SIDED|95.0|-18.5|8.29|||ANCOVA|Between treatment p-values and confidence intervals||||8.29|-18.5|0.4483
71128451|NCT01122849|141762188|SUPERIORITY_OR_OTHER||LS Mean Difference|14.28||||0.0385|TWO_SIDED|95.0|0.79|27.77|||ANCOVA|Between treatment p-values and confidence intervals||||27.77|0.79|0.0385
71128452|NCT01122849|141762188|SUPERIORITY_OR_OTHER||LS Mean difference|-19.37||||0.0046|TWO_SIDED|95.0|-32.5|-6.23|||ANCOVA|Between treatment p-values and confidence intervals||||-6.23|-32.5|0.0046
71128453|NCT01122849|141762189|SUPERIORITY_OR_OTHER||LS Mean Difference|15.24||||0.0029|TWO_SIDED|95.0|5.45|25.02||Between treatment p-values and confidence intervals|ANCOVA|||||25.02|5.45|0.0029
71128454|NCT01122849|141762189|SUPERIORITY_OR_OTHER||LS Mean Difference|3.74||||0.4683|TWO_SIDED|95.0|-6.53|14.01||Between treatment p-values and confidence intervals|ANCOVA|||||14.01|-6.53|0.4683
71128455|NCT01122849|141762189|SUPERIORITY_OR_OTHER||LS Mean Difference|11.5||||0.0259|TWO_SIDED|95.0|1.44|21.55||Between treatment p-values and confidence intervals|ANCOVA|||||21.55|1.44|0.0259
71128456|NCT01122849|141762190|SUPERIORITY_OR_OTHER||LS Mean Difference|7.79||||0.1764|TWO_SIDED|95.0|-3.62|19.19||Between treatment p-values and confidence intervals|ANCOVA|||||19.19|-3.62|0.1764
71128457|NCT01122849|141762190|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63||||0.9183|TWO_SIDED|95.0|-11.7|12.94||Between treatment p-values and confidence intervals|ANCOVA|||||12.94|-11.7|0.9183
71128458|NCT01122849|141762190|SUPERIORITY_OR_OTHER||LS Mean Difference|7.16||||0.2313||95.0|-4.7|19.01||Between treatment p-values and confidence intervals|ANCOVA|||||19.01|-4.70|0.2313
71128459|NCT01122849|141762191|SUPERIORITY_OR_OTHER||LS Mean difference|0.27||||0.1345|TWO_SIDED|95.0|-0.09|0.63||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 7||0.63|-0.09|0.1345
71128460|NCT01122849|141762191|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32||||0.0815|TWO_SIDED|95.0|-0.68|0.04||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 7||0.04|-0.68|0.0815
71128461|NCT01122849|141762191|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59||||0.0015|TWO_SIDED|95.0|0.24|0.94||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 7||0.94|0.24|0.0015
71128462|NCT01122849|141762191|SUPERIORITY_OR_OTHER||LS mean differnence|-1.03||||0.0292||95.0|-1.96|-0.11||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 7||-0.11|-1.96|0.0292
71128463|NCT01122849|141762191|SUPERIORITY_OR_OTHER||LS Mean difference|0.54||||0.2497|TWO_SIDED|95.0|-0.39|1.47||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q4 at Day 7||1.47|-0.39|0.2497
71128464|NCT01122849|141762191|SUPERIORITY_OR_OTHER||LS Mean difference|-1.57||||0.0011|TWO_SIDED|95.0|-2.48|-0.66||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 7||-0.66|-2.48|0.0011
71128465|NCT01122849|141762192|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.8063|TWO_SIDED|95.0|-0.4|0.51||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 14||0.51|-0.40|0.8063
71128466|NCT01122849|141762192|SUPERIORITY_OR_OTHER||LS Mean Differnence|-0.35||||0.1356|TWO_SIDED|95.0|-0.82|0.11||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 14||0.11|-0.82|0.1356
71128467|NCT01122849|141762192|SUPERIORITY_OR_OTHER||LS mean Difference|0.41||||0.0786|TWO_SIDED|95.0|-0.05|0.87|||ANCOVA|||Comparison for Q2 at Day 14||0.87|-0.05|0.0786
71128468|NCT01122849|141762192|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.72||||0.1693|TWO_SIDED|95.0|-1.75|0.32||Between treatment p-values and confidence intervals|ANCOVA|||Comparisons for Q4 at Day 14||0.32|-1.75|0.1693
71128469|NCT01122849|141762192|SUPERIORITY_OR_OTHER||LS Mean difference|1.08||||0.0438|TWO_SIDED|95.0|0.03|2.13||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 14||2.13|0.03|0.0438
71128470|NCT01122849|141762192|SUPERIORITY_OR_OTHER||LS Mean difference|-1.8||||0.0009|TWO_SIDED|95.0|-2.82|-0.78||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 14||-0.78|-2.82|0.0009
71128471|NCT01122849|141762193|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24||||0.1991|TWO_SIDED|95.0|-0.62|0.13||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 7||0.13|-0.62|0.1991
71128472|NCT01122849|141762193|SUPERIORITY_OR_OTHER||LS Mean difference|-0.21||||0.2964|TWO_SIDED|95.0|-0.6|0.19||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q2 at Day 7||0.19|-0.60|0.2964
71128473|NCT01122849|141762193|SUPERIORITY_OR_OTHER||LS mean difference|-0.04||||0.8495|TWO_SIDED|95.0|-0.42|0.35||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q2 at Day 7||0.35|-0.42|0.8495
71128474|NCT01122849|141762193|SUPERIORITY_OR_OTHER||LS mean difference|1.35||||0.0381|TWO_SIDED|95.0|0.08|2.62||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 7||2.62|0.08|0.0381
71128475|NCT01122849|141762193|SUPERIORITY_OR_OTHER||LS mean difference|0.54||||0.4005|TWO_SIDED|95.0|-0.74|1.82||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q4 at Day 7||1.82|-0.74|0.4005
71128476|NCT01122849|141762193|SUPERIORITY_OR_OTHER||LS mean difference|0.81||||0.202|TWO_SIDED|95.0|-0.45|2.07||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q4 at Day 7||2.07|-0.45|0.2020
71128477|NCT01122849|141762194|SUPERIORITY_OR_OTHER||LS Mean difference|-0.09||||0.5741|TWO_SIDED|95.0|-0.41|0.23||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 14||0.23|-0.41|0.5741
71128478|NCT01122849|141762194|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.6935|TWO_SIDED|95.0|-0.26|0.39||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 14||0.39|-0.26|0.6935
71128479|NCT01122849|141762194|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.333|TWO_SIDED|95.0|-0.47|0.16||Between treatment p-values and confidence intervals.|ANCOVA|||Comparison of Q2 at Day 14||0.16|-0.47|0.3330
71128480|NCT01122849|141762194|SUPERIORITY_OR_OTHER||LS Mean difference|1.39||||0.0434|TWO_SIDED|95.0|0.04|2.73||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 14||2.73|0.04|0.0434
71128481|NCT01122849|141762194|SUPERIORITY_OR_OTHER||LS Mean difference|0.32||||0.6333|TWO_SIDED|95.0|-1.02|1.67||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 14||1.67|-1.02|0.6333
71128482|NCT01122849|141762194|SUPERIORITY_OR_OTHER||LS mean difference|1.06||||0.1091|TWO_SIDED|95.0|-0.25|2.37||Between treatment p-values and confidence intervals.|ANCOVA|||Comparison for Q4 at Day 14||2.37|-0.25|0.1091
71128483|NCT03997825|141762213|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.001
71128484|NCT03997825|141762214|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.001
71128485|NCT00383162|141762219|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.5|||<|0.001||95.0|2.17|9.36|||Generalized Estimating Equations|||||9.36|2.17|<0.001
71128486|NCT02726022|141762269|SUPERIORITY_OR_OTHER|||||||0.647|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between gender status (male vs female) was tested using Fisher's exact test.||||0.647
71128487|NCT02726022|141762269|SUPERIORITY_OR_OTHER|||||||0.373|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.||||0.373
71128488|NCT02726022|141762270|SUPERIORITY_OR_OTHER|||||||0.049|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between gender status (male vs female) was tested using Fisher's exact test.||||0.049
71128489|NCT02726022|141762270|SUPERIORITY_OR_OTHER|||||||0.86|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.||||0.860
71128490|NCT02726022|141762271|SUPERIORITY_OR_OTHER|||||||0.921|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between gender status (male vs female) was tested using Fisher's exact test.||||0.921
71128491|NCT02726022|141762271|SUPERIORITY_OR_OTHER|||||||0.962|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.||||0.962
71128492|NCT02726022|141762272|SUPERIORITY_OR_OTHER|||||||0.052|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between gender status (male vs female) was tested using Fisher's exact test.||||0.052
71128493|NCT02726022|141762272|SUPERIORITY_OR_OTHER|||||||0.677|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.||||0.677
71128494|NCT02726022|141762273|SUPERIORITY_OR_OTHER|||||||0.72|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between gender status (male vs female) was tested using Fisher's exact test.||||0.720
71128495|NCT02726022|141762273|SUPERIORITY_OR_OTHER|||||||0.237|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.||||0.237
70858491|NCT02751931|141202994|OTHER||Mean Difference (Net)|-0.94||||0.083|TWO_SIDED|95.0|-2.0|0.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||0.1|-2.0|0.083
71128496|NCT02726022|141762274|SUPERIORITY_OR_OTHER|||||||0.184|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between gender status (male vs female) was tested using Fisher's exact test.||||0.184
71128497|NCT02726022|141762274|SUPERIORITY_OR_OTHER|||||||0.889|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.||||0.889
71128498|NCT00915551|141762275|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
71128499|NCT00915551|141762276|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
71128500|NCT00235716|141762277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.15||||0.03|TWO_SIDED|95.0|0.92|5.39||p-value adjusted for 6 treatment group comparisons.|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||5.39|0.92|0.03
71128501|NCT00235716|141762277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.98||||0.4|TWO_SIDED|95.0|-0.24|4.2||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||4.20|-0.24|0.40
71128502|NCT00235716|141762277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.76||||0.49|TWO_SIDED|95.0|-0.48|4.0||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||4.00|-0.48|0.49
71128503|NCT00235716|141762277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.39||||0.6|TWO_SIDED|95.0|-3.63|0.85||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the vitamin E group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.85|-3.63|0.60
71128504|NCT00235716|141762277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.85|TWO_SIDED|95.0|-2.44|2.01||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||2.01|-2.44|0.85
71128505|NCT00235716|141762277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.18||||0.6|TWO_SIDED|95.0|-1.04|3.39||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||3.39|-1.04|0.60
71128506|NCT00235716|141762278|SUPERIORITY_OR_OTHER|||||||0.69||||||p- value is unadjusted for multiple comparisons because its a 3 degrees of freedom test for any treatment group differences|Log Rank|3 degrees of freedom test||||||0.69
71128507|NCT00235716|141762279|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.19||||0.84|TWO_SIDED|95.0|-0.54|0.92||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.92|-0.54|0.84
71128508|NCT00235716|141762279|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12||||0.84|TWO_SIDED|95.0|-0.61|0.84||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.84|-0.61|0.84
71128509|NCT00235716|141762279|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37||||0.84|TWO_SIDED|95.0|-0.36|1.1||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.10|-0.36|0.84
70858492|NCT02751931|141202994|OTHER||Mean Difference (Net)|-1.12||||0.064|TWO_SIDED|95.0|-2.3|0.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||0.1|-2.3|0.064
71128510|NCT00235716|141762279|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.84||95.0|-0.56|0.9||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the vitamin E group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.90|-0.56|0.84
71128511|NCT00235716|141762279|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25||||0.84|TWO_SIDED|95.0|-0.47|0.98||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.98|-0.47|0.84
71128512|NCT00235716|141762279|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.84|TWO_SIDED|95.0|-0.65|0.8||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.80|-0.65|0.84
71128513|NCT00235716|141762280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8||||0.1|TWO_SIDED|95.0|-3.28|-0.33||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||-0.33|-3.28|0.10
71128514|NCT00235716|141762280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.39||||0.25|TWO_SIDED|95.0|-2.85|0.07||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.07|-2.85|0.25
71128515|NCT00235716|141762280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.65||||0.14|TWO_SIDED|95.0|-3.12|-0.17||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||-0.17|-3.12|0.14
71128516|NCT00235716|141762280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15||||0.84|TWO_SIDED|95.0|-1.32|1.63||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the vitamin E group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.63|-1.32|0.84
71128517|NCT00235716|141762280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26||||0.84|TWO_SIDED|95.0|-1.72|1.21||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.21|-1.72|0.84
71128518|NCT00235716|141762280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41||||0.84|TWO_SIDED|95.0|-1.88|1.06||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.06|-1.88|0.84
71128519|NCT00235716|141762281|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.46||||0.94|TWO_SIDED|95.0|-3.55|0.63||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.63|-3.55|0.94
71128520|NCT00235716|141762281|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||0.94|TWO_SIDED|95.0|-2.47|1.7||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.70|-2.47|0.94
71128521|NCT00235716|141762281|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.94|TWO_SIDED|95.0|-2.57|1.63||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.63|-2.57|0.94
71128522|NCT00235716|141762281|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.99||||0.94|TWO_SIDED|95.0|-1.09|3.07||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the vitamin E group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||3.07|-1.09|0.94
71128523|NCT00235716|141762281|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.94|TWO_SIDED|95.0|-2.16|1.99||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.99|-2.16|0.94
70858493|NCT02751931|141202995|OTHER|||||||0.692||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||||0.692
70858494|NCT02751931|141202995|OTHER|||||||0.018||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||||0.018
71128524|NCT00235716|141762281|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.08||||0.94|TWO_SIDED|95.0|-3.14|0.99||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.99|-3.14|0.94
71128525|NCT00235716|141762282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.79||||0.12|TWO_SIDED|95.0|-3.35|-0.23||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||-0.23|-3.35|0.12
71128526|NCT00235716|141762282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.38||||0.86|TWO_SIDED|95.0|-1.18|1.94||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.94|-1.18|0.86
71128527|NCT00235716|141762282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.86|TWO_SIDED|95.0|-1.7|1.42||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.42|-1.70|0.86
71128528|NCT00235716|141762282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.65||||0.14|TWO_SIDED|95.0|0.11|3.19||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the vitamin E group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||3.19|0.11|0.14
71128529|NCT00235716|141762282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52||||0.86|TWO_SIDED|95.0|-2.07|1.02||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.02|-2.07|0.86
71128530|NCT00235716|141762282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.17||||0.03|TWO_SIDED|95.0|-3.71|-0.63||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||-0.63|-3.71|0.03
71128531|NCT00235716|141762283|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.31|TWO_SIDED|95.0|0.67|1.13||p-value is unadjusted for multiple comparisons|Log Rank||Hazard ratio is for vitamin E group relative to the placebo group.|||1.13|0.67|0.31
71128532|NCT00235716|141762283|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.47|TWO_SIDED|95.0|0.91|1.24||p-value is unadjusted for multiple comparisons|Log Rank||Hazard ratio is for the memantine group relative to the placebo group.|||1.24|0.91|0.47
71128533|NCT00235716|141762283|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.8|TWO_SIDED|95.0|0.57|1.54||p-value is unadjusted for multiple comparisons|Log Rank||Hazard ratio is for the vitamin E + memantine group relative to the placebo group.|||1.54|0.57|0.80
71128534|NCT03036189|141762288|SUPERIORITY||Slope|-0.15||||0.5|TWO_SIDED||||||Mixed Models Analysis|||||||0.50
71128535|NCT03036189|141762289|SUPERIORITY||Slope|0.42||||0.71|TWO_SIDED||||||Mixed Models Analysis|||||||0.71
71128536|NCT03036189|141762290|SUPERIORITY||Slope|0.12||||0.83|TWO_SIDED||||||Mixed Models Analysis|||||||0.83
71128537|NCT03036189|141762291|SUPERIORITY||Slope|0.37||||0.58|TWO_SIDED||||||Mixed Models Analysis|||||||0.58
71128538|NCT03036189|141762292|SUPERIORITY||Slope|-0.4||||0.69|TWO_SIDED||||||Mixed Models Analysis|||||||0.69
71128539|NCT03036189|141762293|SUPERIORITY||Slope|0.49||||0.6|TWO_SIDED||||||Mixed Models Analysis|||||||0.60
71128540|NCT03036189|141762294|SUPERIORITY||Slope|-0.03||||0.97|TWO_SIDED||||||Mixed Models Analysis|||||||0.97
71128541|NCT03036189|141762295|SUPERIORITY||Slope|0.45||||0.49|TWO_SIDED||||||Mixed Models Analysis|||||||0.49
71128542|NCT03036189|141762296|SUPERIORITY||Slope|0.25||||0.77|TWO_SIDED||||||Mixed Models Analysis|||||||0.77
71128543|NCT03036189|141762297|SUPERIORITY||Slope|0.54|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<.05
71128544|NCT03036189|141762298|SUPERIORITY||Slope|1.99||||0.4|TWO_SIDED||||||Mixed Models Analysis|||||||0.40
71128545|NCT03036189|141762299|SUPERIORITY||Slope|1.05||||0.07|TWO_SIDED||||||Mixed Models Analysis|||||||0.07
71128546|NCT03036189|141762300|SUPERIORITY||Slope|2.0||||0.84|TWO_SIDED||||||Mixed Models Analysis|||||||0.84
71128547|NCT03036189|141762301|SUPERIORITY||Slope|-23.01||||0.64|TWO_SIDED||||||Mixed Models Analysis|||||||0.64
71128548|NCT00148941|141762381|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% confidence intervals (CIs) for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.97|||||TWO_SIDED|95.0|0.871|1.08|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of diphtheria toxoid (D) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.080|0.871|
71128549|NCT00148941|141762381|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.961|||||TWO_SIDED|95.0|0.863|1.07|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of diphtheria toxoid (D) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.070|0.863|
71128550|NCT00148941|141762381|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.991|||||TWO_SIDED|95.0|0.89|1.103|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of diphtheria toxoid (D) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.103|0.890|
71128551|NCT00148941|141762381|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.975|||||TWO_SIDED|95.0|0.866|1.097|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of tetanus toxoid (T) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.097|0.866|
71128552|NCT00148941|141762381|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.878|||||TWO_SIDED|95.0|0.78|0.988|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of tetanus toxoid (T) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||0.988|0.780|
71128553|NCT00148941|141762381|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.901|||||TWO_SIDED|95.0|0.8|1.014|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of tetanus toxoid (T) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.014|0.800|
71128554|NCT00148941|141762382|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.938|||||TWO_SIDED|95.0|0.828|1.063|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertussis toxoid (PT) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.063|0.828|
70858495|NCT02751931|141202995|OTHER|||||||0.061||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||||0.061
70858496|NCT02751931|141202995|OTHER|||||||0.008||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||||0.008
71128555|NCT00148941|141762382|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.963|||||TWO_SIDED|95.0|0.85|1.091|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertussis toxoid (PT) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.091|0.850|
71128556|NCT00148941|141762382|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|1.026|||||TWO_SIDED|95.0|0.906|1.162|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertussis toxoid (PT) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.162|0.906|
71128557|NCT00148941|141762382|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.874|||||TWO_SIDED|95.0|0.783|0.976|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of filamentous haemagglutinin (FHA) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||0.976|0.783|
71128558|NCT00148941|141762382|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.947|||||TWO_SIDED|95.0|0.849|1.057|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of filamentous haemagglutinin (FHA) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.057|0.849|
71128559|NCT00148941|141762382|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|1.084|||||TWO_SIDED|95.0|0.971|1.209|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of filamentous haemagglutinin (FHA) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.209|0.971|
71128560|NCT00148941|141762382|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.998|||||TWO_SIDED|95.0|0.867|1.148|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertactin (PRN) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.148|0.867|
71128561|NCT00148941|141762382|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|1.043|||||TWO_SIDED|95.0|0.907|1.2|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertactin (PRN) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.200|0.907|
70858497|NCT02751931|141202995|OTHER|||||||0.612||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||||0.612
70858498|NCT02751931|141202995|OTHER|||||||0.018||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||||0.018
70946757|NCT03672175|141393945|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.11||0.9|TWO_SIDED|95.0|-2.3|2.0||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 182||2.0|-2.3|0.9000
71128562|NCT00148941|141762382|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|1.045|||||TWO_SIDED|95.0|0.909|1.202|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertactin (PRN) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.202|0.909|
71128563|NCT00148941|141762383|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|0.994|||||TWO_SIDED|95.0|0.836|1.181|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 1 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.181|0.836|
71128564|NCT00148941|141762383|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|0.987|||||TWO_SIDED|95.0|0.831|1.172|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 1 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.172|0.831|
71128565|NCT00148941|141762383|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|0.993|||||TWO_SIDED|95.0|0.836|1.18|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 1 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.180|0.836|
71128566|NCT00148941|141762383|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|1.118|||||TWO_SIDED|95.0|0.951|1.314|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 2 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.314|0.951|
71128567|NCT00148941|141762383|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|1.006|||||TWO_SIDED|95.0|0.856|1.183|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 2 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.183|0.856|
71128568|NCT00148941|141762383|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\] for Anti-poliovirus type 2.|GMT ratio|0.9|||||TWO_SIDED|95.0|0.765|1.06|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 2 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.060|0.765|
71128569|NCT00148941|141762383|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|1.112|||||TWO_SIDED|95.0|0.941|1.314|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 3 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.314|0.941|
71128570|NCT00148941|141762383|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|1.034|||||TWO_SIDED|95.0|0.876|1.22|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 3 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.220|0.876|
71128571|NCT00148941|141762383|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|0.93|||||TWO_SIDED|95.0|0.787|1.099|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 3 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.099|0.787|
71128572|NCT00148941|141762383|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|GMT ration|0.792|||||TWO_SIDED|95.0|0.68|0.922|||ANCOVA|ANCOVA model: adjustment for baseline titer - pooled variance||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of anti-poliovirus type 1 (measured by the GMT ratio of Infanrix + IPOL + M-M-R Group over SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|0.922|0.680|
71128573|NCT00148941|141762383|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|GMT ratio|0.802|||||TWO_SIDED|95.0|0.696|0.925|||ANCOVA|ANCOVA model: adjustment for baseline titer - pooled variance||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of anti-poliovirus type 2 (measured by the GMT ratio of Infanrix + IPOL + M-M-R Group over SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|0.925|0.696|
71128574|NCT00148941|141762383|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|GMT ratio|0.938|||||TWO_SIDED|95.0|0.811|1.085|||ANCOVA|ANCOVA model: adjustment for baseline titer - pooled variance||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of anti-poliovirus type 3 (measured by the GMT ratio of Infanrix + IPOL + M-M-R Group over SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|1.085|0.811|
71128575|NCT00148941|141762384|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|Difference between groups|0.47|||||TWO_SIDED|95.0|-0.98|1.21||||||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of diphtheria toxoid (D) booster responses (i.e measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|1.21|-0.98|
70946758|NCT03672175|141393945|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.03||0.5004|TWO_SIDED|95.0|-2.7|1.3||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 182||1.3|-2.7|0.5004
71128576|NCT00148941|141762384|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|Difference between groups|-2.81|||||TWO_SIDED|95.0|-6.55|-0.09||||||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of tetanus toxoid (T) booster responses (measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|-0.09|-6.55|
71128577|NCT00148941|141762385|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|Difference between groups|0.36|||||TWO_SIDED|95.0|-3.83|3.71||||||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of pertussis toxoid (PT) booster responses (measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|3.71|-3.83|
71128578|NCT00148941|141762385|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|Difference between groups|0.79|||||TWO_SIDED|95.0|-2.5|3.21||||||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of filamentous haemagglutinin (FHA) booster responses (measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|3.21|-2.50|
71128579|NCT00148941|141762385|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|Difference between groups|-0.82|||||TWO_SIDED|95.0|-3.79|1.14||||||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of pertactin (PRN) booster responses (measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|1.14|-3.79|
71128580|NCT00148941|141762386|NON_INFERIORITY|Non-inferiority objective was considered demonstrated, when the upper limit of the 95% CI for the difference between groups (SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups minus Infanrix + IPOL + M-M-R Group) in percentage of subjects reporting increased circumferential swelling was equal or less than 2%.|Difference in percentage|-0.41|||||TWO_SIDED|95.0|-1.26|0.16||||||Non-inferiority of the SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of the incidence of increased circumferential swelling at the SB213503 and Infanrix injection site, defined as an injection site swelling diameter that involves \> 50% of the length of the upper arm that also is associated with a \> 30 mm increase of the mid-upper arm circumference compared to the baseline measurement.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|0.16|-1.26|
71128581|NCT03368235|141762413|OTHER||LS mean difference|0.472|STANDARD_ERROR_OF_MEAN|0.4569||0.315|TWO_SIDED|95.0|-0.487|1.431||Based on MMRM model with the baseline DAS28-CRP score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||MMRM = mixed model repeated measures.||1.431|-0.487|0.315
71128582|NCT03368235|141762414|OTHER||Odds Ratio (OR)|0.807||||0.807|TWO_SIDED|95.0|0.12|5.34||Logistic regression model with the treatment group, country and baseline DAS28-CRP as covariate.|Regression, Logistic|||Treatment comparison ACR20: AZD9567 Vs prednisolone||5.34|0.12|0.807
71128583|NCT03368235|141762414|OTHER|||||||0.198|||||||Fisher Exact|||Treatment comparison ACR50: AZD9567 Vs prednisolone||||0.198
71128584|NCT03368235|141762414|OTHER|||||||0.183|||||||Fisher Exact|||Treatment comparison ACR70: AZD9567 Vs prednisolone||||0.183
70946759|NCT03672175|141393946|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8903|TWO_SIDED|95.0|0.65|1.63||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 15: Generalized estimating equation (GEE)||1.63|0.65|0.8903
70946760|NCT03672175|141393946|SUPERIORITY||Odds Ratio (OR)|1.43||||0.1207|TWO_SIDED|95.0|0.91|2.25||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 15||2.25|0.91|0.1207
70858499|NCT02751931|141202995|OTHER|||||||0.858||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children||||0.858
70858500|NCT02751931|141202995|OTHER|||||||0.004||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||||0.004
70858501|NCT02751931|141202995|OTHER|||||||0.003||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||||0.003
70946761|NCT03672175|141393946|SUPERIORITY||Odds Ratio (OR)|1.07||||0.7897|TWO_SIDED|95.0|0.67|1.7||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 42||1.70|0.67|0.7897
70946762|NCT03672175|141393946|SUPERIORITY||Odds Ratio (OR)|1.1||||0.6837|TWO_SIDED|95.0|0.69|1.76||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 42||1.76|0.69|0.6837
71128585|NCT03368235|141762415|OTHER||LS mean difference|0.42|STANDARD_ERROR_OF_MEAN|1.136||0.717|TWO_SIDED|95.0|-1.98|2.81||The MMRM with the baseline SJC66 score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||2.81|-1.98|0.717
71128586|NCT03368235|141762416|OTHER||LS mean difference|-1.12|STANDARD_ERROR_OF_MEAN|3.115||0.724|TWO_SIDED|95.0|-7.69|5.46||The MMRM with the baseline TJC68 score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||5.46|-7.69|0.724
71128587|NCT03368235|141762417|OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|1.6||0.973|TWO_SIDED|95.0|-3.43|3.32||The MMRM with the baseline TJC28 score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||3.32|-3.43|0.973
71128588|NCT03368235|141762418|OTHER||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.837||0.757|TWO_SIDED|95.0|-1.5|2.03||The MMRM with the baseline SJC28 score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||2.03|-1.50|0.757
71128589|NCT03368235|141762419|OTHER||LS mean difference|9.8|STANDARD_ERROR_OF_MEAN|9.67||0.325|TWO_SIDED|95.0|-10.5|30.1||The MMRM with the baseline GH score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||30.1|-10.5|0.325
71128590|NCT03368235|141762420|OTHER||LS mean difference|4.756|STANDARD_ERROR_OF_MEAN|3.4725||0.187|TWO_SIDED|95.0|-2.514|12.025||The MMRM with the baseline CRP score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||12.025|-2.514|0.187
71128591|NCT03368235|141762421|OTHER||LS mean difference|16.0|STANDARD_ERROR_OF_MEAN|10.49||0.144|TWO_SIDED|95.0|-6.0|38.1||The MMRM with the baseline participant's assessment of pain score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||38.1|-6.0|0.144
71128592|NCT03368235|141762422|OTHER||LS mean difference|3.8|STANDARD_ERROR_OF_MEAN|5.73||0.512|TWO_SIDED|95.0|-8.3|16.0||The MMRM with the baseline disease activity score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||16.0|-8.3|0.512
71128593|NCT03368235|141762423|OTHER||LS mean difference|0.131|STANDARD_ERROR_OF_MEAN|0.2381||0.589|TWO_SIDED|95.0|-0.37|0.631||The MMRM with the baseline physical function score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||0.631|-0.370|0.589
71128594|NCT00516165|141762473|SUPERIORITY_OR_OTHER|||||||0.05|||||||Kaplan Meier|||||||0.05
71128595|NCT00516165|141762474|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Kaplan-Meier|||||||<0.05
71128596|NCT00516165|141762475|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Kaplan-Meier|||||||<0.05
71128597|NCT00516165|141762476|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Kaplan-Meier|||||||0.05
71128598|NCT00516165|141762477|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Kaplan-Meier|||||||0.05
71128599|NCT00516165|141762478|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Kaplan-Meier|||||||0.05
71128600|NCT00061633|141762481|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was selected on the basis of clinical judgment and was deemed adequate to provide clinically meaningful descriptive results consistent with study objectives. This sample size was estimated to provide 39% power to test televancin's non-inferiority to vancomycin with respect to clinical response using a non-inferiority margin of 10%.||||||0.5289|||||||2-sided 95% confidence interval|||95% Confidence Interval: -0.1349 to 0.0485 No est. value. Parameter that was estimated: Risk Difference||||0.5289
71128601|NCT02921087|141762486|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|Least-squares adjusted means were obtained and compared.||In order to analyze the 2 x 2 crossover design for the primary outcome (change in overall VAS at day 7) mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.||||0.07
71128602|NCT02921087|141762488|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|Least-squares adjusted means were obtained and compared.||In order to analyze the 2 x 2 crossover design for accommodative response mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.||||0.01
71128603|NCT02921087|141762489|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|Least-squares adjusted means were obtained and compared.||In order to analyze the 2 x 2 crossover design for the change in CISS, mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.||||0.77
71128604|NCT02921087|141762490|SUPERIORITY|||||||0.69|||||||Mixed Models Analysis|Least-squares adjusted means were obtained and compared.||In order to analyze the 2 x 2 crossover design for the CLDEQ-8, mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.||||0.69
71128605|NCT02921087|141762491|SUPERIORITY|||||||0.87|||||||Mixed Models Analysis|Least-squares adjusted means were obtained and compared.||In order to analyze the 2 x 2 crossover design for phoria, mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.||||0.87
71128606|NCT02964767|141762518|OTHER||||||<|0.049|||||||t-test, 2 sided|||||||<0.049
71128607|NCT03109184|141762519|SUPERIORITY||Odds Ratio (OR)|1.21|||||TWO_SIDED||||||||3-Month follow-up between groups odds ratio of DV perpetration|||||
71128608|NCT03109184|141762519|SUPERIORITY||Odds Ratio (OR)|0.61|||||TWO_SIDED||||||||9-month follow-up between group odds ratio of DV perpetration|||||
71128609|NCT03109184|141762519|SUPERIORITY||Odds Ratio (OR)|1.79|||||TWO_SIDED||||||||3-month follow-up between groups odds ratio of DV victimization|||||
71128610|NCT03109184|141762519|SUPERIORITY||Odds Ratio (OR)|0.86|||||TWO_SIDED||||||||9-month follow-up between groups odds ratio of DV victimization|||||
71128611|NCT03109184|141762520|SUPERIORITY||Effect Size (d)|-0.07|||||TWO_SIDED||||||||3-month follow-up between groups effect size of general aggression|||||
71128612|NCT03109184|141762520|SUPERIORITY||Effect Size (d)|0.01|||||TWO_SIDED||||||||9-month follow-up between groups effect size of general aggression|||||
71128613|NCT03109184|141762521|SUPERIORITY||Effect Size (d)|0.01|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent attitudes support aggression|||||
71128614|NCT03109184|141762521|SUPERIORITY||Effect Size (d)|-0.17|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent attitudes support aggression|||||
71128615|NCT03109184|141762521|SUPERIORITY||Effect Size (d)|0.19|||||TWO_SIDED||||||||3-month follow-up between groups effect size of parent attitudes support aggression|||||
71128616|NCT03109184|141762521|SUPERIORITY||Effect Size (d)|0.2|||||TWO_SIDED||||||||9-month follow-up between groups effect size of parent attitudes support aggression|||||
71128617|NCT03109184|141762522|SUPERIORITY||Effect Size (d)|0.09|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent short-term self-regulation|||||
70858502|NCT02751931|141202995|OTHER||||||<|0.001||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||||< 0.001
71128618|NCT03109184|141762522|SUPERIORITY||Effect Size (d)|0.36|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent short-term self-regulation|||||
71128619|NCT03109184|141762522|SUPERIORITY||Effect Size (d)|-0.11|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent long-term self-regulation|||||
71128620|NCT03109184|141762522|SUPERIORITY||Effect Size (d)|0.11|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent long-term self-regulation|||||
71128621|NCT03109184|141762523|SUPERIORITY||Effect Size (d)|0.11|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent reported open family communication|||||
71128622|NCT03109184|141762523|SUPERIORITY||Effect Size (d)|0.06|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent reported open family communication|||||
71128623|NCT03109184|141762523|SUPERIORITY||Effect Size (d)|-0.15|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent reported problems in family communication|||||
71128624|NCT03109184|141762523|SUPERIORITY||Effect Size (d)|0.06|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent reported problems in family communication|||||
71128625|NCT03109184|141762523|SUPERIORITY||Effect Size (d)|0.62|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent reported number of relationship topics discussed|||||
71128626|NCT03109184|141762523|SUPERIORITY||Effect Size (d)|0.13|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent reported number of relationship topics discussed|||||
71128627|NCT03109184|141762523|SUPERIORITY||Effect Size (d)|0.15|||||TWO_SIDED||||||||3-month follow-up between groups effect size of parent reported open family communication|||||
71128628|NCT03109184|141762523|SUPERIORITY||Effect Size (d)|0.01|||||TWO_SIDED||||||||9-month follow-up between groups effect size of parent reported open family communication|||||
70858503|NCT02751931|141202995|OTHER|||||||0.045||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||||0.045
70858504|NCT02751931|141202995|OTHER|||||||0.002||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||||0.002
71128629|NCT03109184|141762523|SUPERIORITY||Effect Size (d)|-0.15|||||TWO_SIDED||||||||3-month follow-up between groups effect size of parent reported problems in family communication|||||
71128630|NCT03109184|141762523|SUPERIORITY||Effect Size (d)|0.25|||||TWO_SIDED||||||||9-month follow-up between groups effect size of parent reported problems in family communication|||||
71128631|NCT03109184|141762523|SUPERIORITY||Effect Size (d)|0.66|||||TWO_SIDED||||||||3-month follow-up between groups effect size of parent reported number of relationship topics discussed|||||
71128632|NCT03109184|141762523|SUPERIORITY||Effect Size (d)|-0.1|||||TWO_SIDED||||||||9-month follow-up between groups effect size of parent reported number of relationship topics discussed|||||
71128633|NCT03109184|141762524|SUPERIORITY||Effect Size (d)|0.15|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent emotion-regulation|||||
71128634|NCT03109184|141762524|SUPERIORITY||Effect Size (d)|0.32|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent emotion-regulation|||||
71128635|NCT03109184|141762525|SUPERIORITY||Effect Size (d)|-0.11|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent distress tolerance|||||
71128636|NCT03109184|141762525|SUPERIORITY||Effect Size (d)|0.23|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent distress tolerance|||||
71128637|NCT00602420|141762526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67||||0.037|TWO_SIDED|95.0|0.1|3.24|||t-test, 2 sided|||Tested at the two-sided 0.05 significance level.||3.24|0.10|0.037
71128638|NCT00602420|141762526|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Tested at the two-sided 0.05 significance level.||||0.007
71128639|NCT01031979|141762670|SUPERIORITY_OR_OTHER||Beta|-1.44|||<|0.001|TWO_SIDED|95.0|-2.29|-0.59|||mixed effects/hierarchical linear model|||||-0.59|-2.29|<0.001
71128640|NCT01031979|141762671|SUPERIORITY_OR_OTHER||Slope|-0.87||||0.39|TWO_SIDED||||||Hierarchical Linear Modeling|||||||.39
71128641|NCT01031979|141762672|SUPERIORITY_OR_OTHER||Slope|-0.55||||0.58|TWO_SIDED||||||Hierarchical Linear Modeling|||||||.58
71128642|NCT01031979|141762673|SUPERIORITY_OR_OTHER||Beta|-1.6||||0.03|TWO_SIDED|95.0|-2.71|-0.49|||Hierarchical Linear Modeling|||||-0.49|-2.71|.03
71128643|NCT03592368|141762677|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71128644|NCT03592368|141762679|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
71128645|NCT03592368|141762680|SUPERIORITY|||||||0.12|||||||t-test, 1 sided|||||||0.12
71128646|NCT03831100|141762681|SUPERIORITY||Mean Difference (Net)|-2.1||||0.25|TWO_SIDED|90.0|-5.0|0.9||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|Regression, Linear||The mean for each study arm represents the mean difference in the score at the post-treatment timepoint relative to the score at baseline. The mean difference (net) represents the mean model-based difference between study arms.|||0.9|-5.0|0.25
71128647|NCT03831100|141762682|SUPERIORITY||Mean Difference (Net)|-5.8||||0.006|TWO_SIDED|90.0|-9.1|-2.5||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|Regression, Linear||The mean for each study arm represents the mean difference in the score at the post-treatment timepoint relative to the score at baseline. The mean difference (net) represents the mean model-based difference between study arms.|||-2.5|-9.1|.006
71128648|NCT03831100|141762683|SUPERIORITY||Mean Difference (Net)|-7.9||||0.1|TWO_SIDED|90.0|-15.9|0.0||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|Regression, Linear||The mean for each study arm represents the mean difference in the score at the post-treatment timepoint relative to the score at baseline. The mean difference (net) represents the mean model-based difference between study arms.|||0.0|-15.9|.10
71128649|NCT03831100|141762684|SUPERIORITY||Mean Difference (Net)|-17.1||||0.002|TWO_SIDED|90.0|-25.6|-8.6||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|Regression, Linear|||||-8.6|-25.6|.002
70858505|NCT02751931|141202995|OTHER|||||||0.006||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||||0.006
70858506|NCT02751931|141202995|OTHER|||||||0.007||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||||0.007
71128650|NCT03831100|141762685|SUPERIORITY||Mean Difference (Net)|-3.4||||0.3|TWO_SIDED|90.0|-8.8|2.0||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores|||2.0|-8.8|0.30
71128651|NCT03831100|141762686|SUPERIORITY||Median Difference (Net)|-9.7||||0.005|TWO_SIDED|90.0|-15.2|-4.2||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||-4.2|-15.2|0.005
71128652|NCT03831100|141762687|SUPERIORITY||Mean Difference (Net)|-3.4||||0.064|TWO_SIDED|90.0|-6.4|0.4||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||0.4|-6.4|0.064
71128653|NCT03831100|141762688|SUPERIORITY||Mean Difference (Net)|-4.3||||0.046|TWO_SIDED|90.0|-7.8|-0.8||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||-0.8|-7.8|0.046
71128654|NCT03831100|141762689|SUPERIORITY||Mean Difference (Net)|-1.5||||0.49|TWO_SIDED|90.0|-5.2|2.1||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||2.1|-5.2|0.49
71128655|NCT03831100|141762690|SUPERIORITY||Mean Difference (Net)|-3.1||||0.14|TWO_SIDED|90.0|-6.5|0.3||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||0.3|-6.5|0.14
71128656|NCT03831100|141762691|SUPERIORITY||Mean Difference (Net)|3.2||||0.082|TWO_SIDED|90.0|0.2|6.3||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||6.3|0.2|0.082
71128657|NCT03831100|141762692|SUPERIORITY||Mean Difference (Net)|2.7||||0.15|TWO_SIDED|90.0|-0.4|5.7||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||5.7|-0.4|0.15
71128658|NCT03831100|141762693|SUPERIORITY||Mean Difference (Net)|-2.2||||0.22|TWO_SIDED|90.0|-5.2|-0.7||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||-0.7|-5.2|0.22
71128659|NCT03831100|141762694|SUPERIORITY||Mean Difference (Net)|-2.9||||0.093|TWO_SIDED|90.0|-5.8|-0.1||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||-0.1|-5.8|0.093
71128660|NCT01107665|141762714|OTHER||Log Rank HR|0.784||||0.49|TWO_SIDED|95.0|0.41|1.54|||Log Rank|||||1.54|.41|0.49
71128661|NCT02008227|141762717|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.0003|TWO_SIDED|95.0|0.62|0.87|||Log Rank|||Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).||0.87|0.62|0.0003
71128662|NCT02008227|141762717|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.0002|TWO_SIDED|95.0|0.62|0.86|||Log Rank|||Unstratified Analysis||0.86|0.62|0.0002
71128663|NCT02008227|141762718|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.0102|TWO_SIDED|95.0|0.58|0.93|||Log Rank|||Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.||0.93|0.58|0.0102
71128664|NCT02008227|141762718|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72||||0.0052|TWO_SIDED|95.0|0.58|0.91|||Log Rank|||Unstratified Analysis||0.91|0.58|0.0052
71128665|NCT02008227|141762721|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.95||||0.4928|TWO_SIDED|95.0|0.82|1.1|||Log Rank|||Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.||1.10|0.82|0.4928
71128666|NCT02008227|141762721|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.3596|TWO_SIDED|95.0|0.81|1.08|||Log Rank|||Unstratified Analysis||1.08|0.81|0.3596
71128667|NCT02008227|141762722|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.3806|TWO_SIDED|95.0|0.74|1.12|||Log Rank|||Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.||1.12|0.74|0.3806
71128668|NCT02008227|141762722|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.3249|TWO_SIDED|95.0|0.74|1.1|||Log Rank|||Unstratified Analysis||1.10|0.74|0.3249
71128669|NCT02008227|141762725|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.31|||<|0.0001|TWO_SIDED|95.0|0.18|0.55|||Log Rank|||Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.||0.55|0.18|<0.0001
71128670|NCT02008227|141762725|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.34|||<|0.0001|TWO_SIDED|95.0|0.21|0.55|||Log Rank|||Unstratified Analysis||0.55|0.21|<0.0001
71128671|NCT02008227|141762726|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.31||||0.0006|TWO_SIDED|95.0|0.15|0.62|||Log Rank|||Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.||0.62|0.15|0.0006
71128672|NCT02008227|141762726|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.38||||0.0003|TWO_SIDED|95.0|0.22|0.65|||Log Rank|||Unstratified Analysis||0.65|0.22|0.0003
71128673|NCT02008227|141762730|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72||||0.0111|TWO_SIDED|95.0|0.55|0.93|||Log Rank|||Pain in Chest: Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.||0.93|0.55|0.0111
71128674|NCT02008227|141762730|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.06||||0.6305|TWO_SIDED|95.0|0.84|1.33|||Log Rank|||Cough: Unstratified Analysis||1.33|0.84|0.6305
71128675|NCT02008227|141762730|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.7406|TWO_SIDED|95.0|0.81|1.16|||Log Rank|||Dyspnea: Unstratified Analysis||1.16|0.81|0.7406
71128676|NCT02008227|141762730|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92||||0.5221|TWO_SIDED|95.0|0.73|1.17|||Log Rank|||Arm/Shoulder Pain||1.17|0.73|0.5221
71128677|NCT02008227|141762745|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8||||0.0012|TWO_SIDED|95.0|0.7|0.92|||Log Rank|||Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).||0.92|0.70|0.0012
71128678|NCT02008227|141762746|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.0045|TWO_SIDED|95.0|0.64|0.92|||Log Rank|||Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).||0.92|0.64|0.0045
71128679|NCT02008227|141762747|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.64||||0.0012|TWO_SIDED|95.0|0.49|0.84|||Log Rank|||Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).||0.84|0.49|0.0012
71128680|NCT02008227|141762748|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.3|0.68|||Log Rank|||Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).||0.68|0.30|<0.0001
71128681|NCT02008227|141762749|SUPERIORITY_OR_OTHER_LEGACY||Stratified Hazard Ratio|0.96||||0.4981|TWO_SIDED|95.0|0.85|1.08|||Log Rank|||||1.08|0.85|0.4981
71128682|NCT02008227|141762751|SUPERIORITY_OR_OTHER_LEGACY||Unstratified Hazard Ratio|0.32|||||TWO_SIDED|95.0|0.21|0.48||||||||0.48|0.21|
71128683|NCT01618695|141762764|SUPERIORITY||Median Difference (Final Values)|-5.09||||0.233|TWO_SIDED|95.0|-14.112|4.519|||ANCOVA||Median Difference to placebo and the 95 percent (%) confidence interval are based on the Hodges-Lehmann method.|||4.519|-14.112|0.2330
71128684|NCT01618695|141762764|SUPERIORITY||Median Difference (Final Values)|-16.45||||0.0003|TWO_SIDED|95.0|-25.683|-7.251|||ANCOVA||Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.|||-7.251|-25.683|0.0003
71128685|NCT01618695|141762764|SUPERIORITY||Median Difference (Final Values)|-24.95|||<|0.0001|TWO_SIDED|95.0|-33.878|-16.235|||ANCOVA||Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.|||-16.235|-33.878|<0.0001
71128686|NCT01618695|141762765|SUPERIORITY|||||||0.3954|||||||Cochran-Mantel-Haenszel|||||||0.3954
71128687|NCT01618695|141762765|SUPERIORITY|||||||0.0005|||||||Cochran-Mantel-Haenszel|||||||0.0005
71128688|NCT01618695|141762765|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71128689|NCT01618695|141762766|SUPERIORITY||Median Difference (Final Values)|-8.27||||0.0552|TWO_SIDED|95.0|-18.067|1.671|||ANCOVA||Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.|||1.671|-18.067|0.0552
71128690|NCT01618695|141762766|SUPERIORITY||Median Difference (Final Values)|-21.21|||<|0.0001|TWO_SIDED|95.0|-30.941|-11.368|||ANCOVA||Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.|||-11.368|-30.941|<0.0001
71128691|NCT01618695|141762766|SUPERIORITY||Median Difference (Final Values)|-28.65|||<|0.0001|TWO_SIDED|95.0|-37.698|-19.794|||ANCOVA||Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.|||-19.794|-37.698|<0.0001
71128692|NCT01128192|141762780|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED|||||Two sided P value|ANOVA|||Change in fasting plasma glucose level||||0.240
71128693|NCT01128192|141762780|SUPERIORITY_OR_OTHER|||||||0.339|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in fasting plasma glucose level||||0.339
71128694|NCT01128192|141762781|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-30 minutes||||<0.001
71128695|NCT01128192|141762781|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P Value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 30-180 minutes||||<0.001
71128696|NCT01128192|141762781|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P Value|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes||||<0.001
71128697|NCT01128192|141762781|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-30 minutes||||<0.001
71128698|NCT01128192|141762781|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 30-180 minutes||||<0.001
71128699|NCT01128192|141762781|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes||||<0.001
71128700|NCT01128192|141762782|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in fasting plasma insulin level||||0.019
71128701|NCT01128192|141762782|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in fasting plasma insulin level||||<0.001
71128702|NCT01128192|141762783|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-30 minutes||||<0.001
71128703|NCT01128192|141762783|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 30-180 minutes||||<0.001
71128704|NCT01128192|141762783|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes||||<0.001
71128705|NCT01128192|141762783|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-30 minutes||||<0.001
71128706|NCT01128192|141762783|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 30-180 minutes||||<0.001
71128707|NCT01128192|141762783|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes||||<0.001
71128708|NCT01128192|141762784|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Baseline Insulin Level||||<0.001
71128709|NCT01128192|141762784|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value|ANOVA|||Change in Baseline Insulin Level||||<0.001
71128710|NCT01128192|141762785|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-10 minutes||||<0.001
71128711|NCT01128192|141762785|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 10-180 minutes||||<0.001
71128712|NCT01128192|141762785|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes||||<0.001
71128713|NCT01128192|141762785|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-10 minutes||||<0.001
71128714|NCT01128192|141762785|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 10-180 minutes||||<0.001
71128715|NCT01128192|141762785|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes||||<0.001
71128716|NCT01128192|141762786|SUPERIORITY_OR_OTHER|||||||0.608|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Basal EGP||||0.608
71128717|NCT01128192|141762786|SUPERIORITY_OR_OTHER|||||||0.132|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Basal EGP||||0.132
71128718|NCT01128192|141762787|SUPERIORITY_OR_OTHER|||||||0.178|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Low-Dose % EGP Inhibition||||0.178
71128719|NCT01128192|141762787|SUPERIORITY_OR_OTHER|||||||0.111|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Low-Dose % EGP Inhibition||||0.111
71128720|NCT01128192|141762788|SUPERIORITY_OR_OTHER|||||||0.573|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in high-dose % EGP Inhibition||||0.573
71128721|NCT01128192|141762789|SUPERIORITY_OR_OTHER|||||||0.956|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Low-Dose Glucose Disposal Rate (GDR)||||0.956
71128722|NCT01128192|141762789|SUPERIORITY_OR_OTHER|||||||0.125|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Low-Dose Glucose Disposal Rate (GDR)||||0.125
71128723|NCT01128192|141762790|SUPERIORITY_OR_OTHER|||||||0.993|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in High-Dose Glucose Disposal Rate (GDR)||||0.993
71128724|NCT01128192|141762790|SUPERIORITY_OR_OTHER|||||||0.956|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in High-Dose Glucose Disposal Rate (GDR)||||0.956
71128725|NCT03354273|141762800|OTHER|Sensitivity was compared to a pre-specified threshold of 60%.|||||<|0.0001|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Reader 1: Sensitivity||||<0.0001
70946763|NCT03672175|141393946|SUPERIORITY||Odds Ratio (OR)|0.88||||0.6602|TWO_SIDED|95.0|0.51|1.53||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 182||1.53|0.51|0.6602
71128726|NCT03354273|141762800|OTHER|Specificity was compared to a pre-specified threshold of 60%.||||||0.0182|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Reader 1: Specificity||||0.0182
71128727|NCT03354273|141762800|OTHER|Sensitivity was compared to a pre-specified threshold of 60%.|||||<|0.0001|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Reader 2: Sensitivity||||<0.0001
71128728|NCT03354273|141762800|OTHER|Specificity was compared to a pre-specified threshold of 60%.||||||0.0002|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Reader 2: Specificity||||0.0002
71128729|NCT03354273|141762800|OTHER|Sensitivity was compared to a pre-specified threshold of 60%.|||||<|0.0001|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Reader 3: Sensitivity||||<0.0001
71128730|NCT03354273|141762800|OTHER|Specificity was compared to a pre-specified threshold of 60%.||||||0.997|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Reader 3: Specificity||||0.9970
71128731|NCT03354273|141762800|OTHER|Sensitivity was compared to a pre-specified threshold of 60%.|||||<|0.0001|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Majority Rule: Sensitivity||||<0.0001
71128732|NCT03354273|141762800|OTHER|Specificity was compared to a pre-specified threshold of 60%.||||||0.0781|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Majority Rule: Specificity||||0.0781
71128733|NCT03354273|141762801|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|14.5|||<|0.0001|TWO_SIDED|95.0|6.5|22.4|||McNemar|The hypothesis tests were 1-sided McNemar's tests with a significance level of 0.025 for sensitivity.||Reader 1: Sensitivity||22.4|6.5|<0.0001
71128734|NCT03354273|141762801|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|2.4||||0.0004|TWO_SIDED|95.0|-4.9|9.7|||Nam's RMLE|||Reader 1: Specificity||9.7|-4.9|0.0004
71128735|NCT03354273|141762801|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|12.9||||0.0002|TWO_SIDED|95.0|4.7|21.0|||McNemar|||Reader 2: Sensitivity||21.0|4.7|0.0002
71128736|NCT03354273|141762801|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|4.9|||<|0.0001|TWO_SIDED|95.0|-2.1|11.8|||Nam's RMLE|||Reader 2: Specificity||11.8|-2.1|<0.0001
71128737|NCT03354273|141762801|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|13.3|||<|0.0001|TWO_SIDED|95.0|6.6|19.9|||McNemar|||Reader 3: Sensitivity||19.9|6.6|<0.0001
71128738|NCT03354273|141762801|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|1.2||||0.0011|TWO_SIDED|95.0|-6.0|8.4|||Nam's RMLE|||Reader 3: Specificity||8.4|-6.0|0.0011
71128739|NCT03354273|141762801|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|11.6||||0.0003|TWO_SIDED|95.0|4.1|19.2|||McNemar|||Majority Rule: Sensitivity||19.2|4.1|0.0003
71128740|NCT03354273|141762801|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|2.1||||0.0004|TWO_SIDED|95.0|-5.0|9.3|||Nam's RMLE|||Majority Rule: Specificity||9.3|-5.0|0.0004
70946764|NCT03672175|141393946|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9268|TWO_SIDED|95.0|0.56|1.69||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 182||1.69|0.56|0.9268
71128741|NCT03354273|141762802|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|24.4||||0.0127|TWO_SIDED|95.0|5.4|43.4|||McNemar|||Reader 1: Sensitivity||43.4|5.4|0.0127
70858507|NCT02751931|141202996|OTHER||Mean Difference (Net)|0.34||||0.018|TWO_SIDED|95.0|0.1|0.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||0.6|0.1|0.018
70858508|NCT02751931|141202996|OTHER||Mean Difference (Net)|0.82||||0.045|TWO_SIDED|95.0|0.0|1.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||1.6|0.0|0.045
70858509|NCT02751931|141202996|OTHER||Mean Difference (Net)|0.68||||0.013|TWO_SIDED|95.0|0.1|1.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||1.2|0.1|0.013
70858510|NCT02751931|141202996|OTHER||Mean Difference (Net)|1.36||||0.002|TWO_SIDED|95.0|0.6|2.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||2.2|0.6|0.002
70858511|NCT02751931|141202996|OTHER||Mean Difference (Net)|1.14||||0.001|TWO_SIDED|95.0|0.5|1.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||1.8|0.5|0.001
70858512|NCT02751931|141202996|OTHER||Mean Difference (Net)|2.26|||<|0.001|TWO_SIDED|95.0|1.2|3.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||3.3|1.2|<0.001
70858513|NCT02751931|141202996|OTHER||Mean Difference (Net)|1.31||||0.001|TWO_SIDED|95.0|0.5|2.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children||2.1|0.5|0.001
70858514|NCT02751931|141202996|OTHER||Mean Difference (Net)|1.93|||<|0.001|TWO_SIDED|95.0|0.9|3.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||3.0|0.9|<0.001
70858515|NCT02751931|141202996|OTHER||Mean Difference (Net)|1.34|||<|0.001|TWO_SIDED|95.0|0.7|2.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||2.0|0.7|<0.001
70858516|NCT02751931|141202996|OTHER||Mean Difference (Net)|2.17|||<|0.001|TWO_SIDED|95.0|1.2|3.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||3.2|1.2|<0.001
70858517|NCT02751931|141202996|OTHER||Mean Difference (Net)|1.33||||0.002|TWO_SIDED|95.0|0.5|2.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||2.1|0.5|0.002
71128742|NCT03354273|141762802|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|9.5||||0.0001|TWO_SIDED|95.0|-1.2|20.2|||Nam's RMLE|||Reader 1: Specificity||20.2|-1.2|0.0001
71128743|NCT03354273|141762802|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|22.0||||0.0195|TWO_SIDED|95.0|2.2|41.7|||McNemar|||Reader 2: Sensitivity||41.7|2.2|0.0195
71128744|NCT03354273|141762802|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|6.8||||0.0004|TWO_SIDED|95.0|-3.2|16.8|||Nam's RMLE|||Reader 2: Specificity||16.8|-3.2|0.0004
71128745|NCT03354273|141762802|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|17.1||||0.0174|TWO_SIDED|95.0|1.7|32.4|||McNemar|||Reader 3: Sensitivity||32.4|1.7|0.0174
71128746|NCT03354273|141762802|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|0.7||||0.024|TWO_SIDED|95.0|-9.9|11.3|||Nam's RMLE|||||11.3|-9.9|0.0240
71128747|NCT03354273|141762802|SUPERIORITY||Difference between PET MPI and SPECT MPI|17.1||||0.0448|TWO_SIDED|95.0|-1.5|35.6|||McNemar|||Majority Rule: Sensitivity||35.6|-1.5|0.0448
71128748|NCT03354273|141762802|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|6.8||||0.0004|TWO_SIDED|95.0|-3.4|17.0|||Nam's RMLE|||Majority Rule: Specificity||17.0|-3.4|0.0004
71128749|NCT03354273|141762803|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|12.0||||0.0116|TWO_SIDED|95.0|0.0|23.9|||McNemar|||Reader 1: Sensitivity||23.9|0.0|0.0116
71128750|NCT03354273|141762803|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|6.6||||0.0003|TWO_SIDED|95.0|-2.9|16.2|||Nam's RMLE|||Reader 1: Specificity||16.2|-2.9|0.0003
71128751|NCT03354273|141762803|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|6.8||||0.1085|TWO_SIDED|95.0|-5.2|18.9|||McNemar|||Reader 2: Sensitivity||18.9|-5.2|0.1085
71128752|NCT03354273|141762803|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|11.6|||<|0.0001|TWO_SIDED|95.0|2.1|21.1|||Nam's RMLE|||Reader 2: Specificity||21.1|2.1|<0.0001
71128753|NCT03354273|141762803|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|13.7||||0.0017|TWO_SIDED|95.0|3.8|23.5|||McNemar|||Reader 3: Sensitivity||23.5|3.8|0.0017
71128754|NCT03354273|141762803|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|2.8||||0.0034|TWO_SIDED|95.0|-6.6|12.1|||Nam's RMLE|||Reader 3: Specificity||12.1|-6.6|0.0034
71128755|NCT03354273|141762803|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|7.7||||0.0641|TWO_SIDED|95.0|-3.6|19.0|||McNemar|||Majority Rule: Sensitivity||19.0|-3.6|0.0641
71128756|NCT03354273|141762803|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|5.0||||0.001|TWO_SIDED|95.0|-4.6|14.6|||Nam's RMLE|||Majority Rule: Specificity||14.6|-4.6|0.0010
71128757|NCT03354273|141762804|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|11.0||||0.0294|TWO_SIDED|95.0|-2.6|24.6|||McNemar|||Reader 1: Sensitivity||24.6|-2.6|0.0294
71128758|NCT03354273|141762804|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|3.9||||0.0117|TWO_SIDED|95.0|-8.3|16.1|||Nam's RMLE|||Reader 1: Specificity||16.1|-8.3|0.0117
71128759|NCT03354273|141762804|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|6.6||||0.1444|TWO_SIDED|95.0|-7.1|20.3|||McNemar|||Reader 2: Sensitivity||20.3|-7.1|0.1444
70858518|NCT02751931|141202996|OTHER||Mean Difference (Net)|1.88|||<|0.001|TWO_SIDED|95.0|1.0|2.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||2.8|1.0|<0.001
71128760|NCT03354273|141762804|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|11.7||||0.0001|TWO_SIDED|95.0|-0.4|23.7|||Nam's RMLE|||Reader 2: Specificity||23.7|-0.4|0.0001
71128761|NCT03354273|141762804|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|8.8||||0.044|TWO_SIDED|95.0|-1.3|18.9|||McNemar|||Reader 3: Sensitivity||18.9|-1.3|0.0440
70946765|NCT03672175|141393947|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8245|TWO_SIDED|95.0|0.62|1.83||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 15||1.83|0.62|0.8245
71128762|NCT03354273|141762804|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|7.8||||0.0022|TWO_SIDED|95.0|-4.8|20.3|||Nam's RMLE|||Reader 3: Specificity||20.3|-4.8|0.0022
71128763|NCT03354273|141762804|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|4.4||||0.2164|TWO_SIDED|95.0|-8.4|17.2|||McNemar|||Majority Rule: Sensitivity||17.2|-8.4|0.2164
71128764|NCT03354273|141762804|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|9.7||||0.0006|TWO_SIDED|95.0|-2.6|22.0|||Nam's RMLE|||Majority Rule: Specificity||22.0|-2.6|0.0006
71128765|NCT03121365|141762815|EQUIVALENCE|0.05||||||0.7635|TWO_SIDED|95.0|||||t-test, 2 sided|||Bayley Scales of Infant and Toddler Development Cognitive Composite Scores between infants 12-18 months old in the Standard and Digital Arms||||.7635
71128766|NCT03121365|141762815|EQUIVALENCE|0.05||||||0.0996|||||||t-test, 2 sided|||Language Composite Scores between infants 12-18 months old in the Standard and Digital Arms||||.0996
71128767|NCT03121365|141762815|EQUIVALENCE|0.05||||||0.2291|||||||t-test, 2 sided|||Gross Motor Composite Scores between infants 12-18 months old in the Standard and Digital Arms||||.2291
71128768|NCT03121365|141762816|EQUIVALENCE|0.05||||||0.018|||||||t-test, 2 sided|||StimQ scores between infants 6 months of age and 9 months of age in the board book arm and e-book arm||||.0180
71128769|NCT03121365|141762816|EQUIVALENCE|0.05||||||0.4144|||||||t-test, 2 sided|||StimQ scores between infants 9 months of age and 12 months of age in the board book arm and e-book arm||||.4144
71128770|NCT03121365|141762816|EQUIVALENCE|0.05||||||0.4251|||||||t-test, 2 sided|||StimQ scores between infants 6 months of age and 12 months of age in the board book arm and e-book arm||||.4251
71128771|NCT03121365|141762817|SUPERIORITY|||||||0.235||||||Difference in Board Book Reading|Chi-squared|||||||0.235
71128772|NCT03121365|141762818|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71128773|NCT03121365|141762819|SUPERIORITY|||||||0.601|||||||Chi-squared|||||||0.601
71128774|NCT03121365|141762820|SUPERIORITY|||||||0.219|||||||Chi-squared|||||||0.219
71128775|NCT03121365|141762821|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71128776|NCT03121365|141762822|SUPERIORITY|||||||0.574|||||||Chi-squared|||||||0.574
71128777|NCT03121365|141762823|SUPERIORITY|||||||0.43|||||||Chi-squared|||||||0.430
71128778|NCT03121365|141762824|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71128779|NCT03121365|141762825|SUPERIORITY|||||||0.861|||||||Chi-squared|||||||0.861
71128780|NCT00746863|141762827|SUPERIORITY_OR_OTHER|||||||0.0251||95.0||||A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.|Wilcoxon (Mann-Whitney)|||A 2.0 cm difference on a 10.0 cm VAS scale was clinically significant. Assuming a power of 80% to detect a 2.0 difference on scores between groups, standard deviation of 2.2, an α of 0.05, then, 21 patients would be needed in each group for a total of 42 subjects. A t-test was used in comparing the intervention and control groups, if continuous variables were approximately normal. If data were not approximately normal, a Mann-Whitney Wilcoxon test was used in comparing the two groups.||||0.0251
71128781|NCT00746863|141762828|SUPERIORITY_OR_OTHER|||||||0.0923||95.0||||Adjusted for multiple comparisions|Wilcoxon (Mann-Whitney)|||A t-test was used in comparing the intervention and control groups, if continuous variables were approximately normal. If data were not approximately normal, a Mann-Whitney Wilcoxon test was used in comparing the two groups.||||0.0923
71128782|NCT00746863|141762829|SUPERIORITY_OR_OTHER|||||||0.4756||95.0|||||Chi-squared|||Chi square was performed to compared the two groups and the patient's ability to pass their voiding trial prior to discharge||||0.4756
71128783|NCT00746863|141762830|SUPERIORITY_OR_OTHER|||||||0.258||95.0||||A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.|Wilcoxon (Mann-Whitney)|||A t-test was used in comparing the intervention and control groups, if continuous variables were approximately normal. If data were not approximately normal, a Mann-Whitney Wilcoxon test was used in comparing the two groups. Normality of continuous variables was assessed using the Shapiro-Wilk test. For categorical data, Fisher's exact test was used to evaluate the data. A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.||||0.258
70946766|NCT03672175|141393947|SUPERIORITY||Odds Ratio (OR)|1.59||||0.0756|TWO_SIDED|95.0|0.95|2.67||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 15||2.67|0.95|0.0756
70946767|NCT03672175|141393947|SUPERIORITY||Odds Ratio (OR)|1.18||||0.5309|TWO_SIDED|95.0|0.7|2.01||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 42||2.01|0.70|0.5309
70858519|NCT02751931|141202996|OTHER||Mean Difference (Net)|1.38||||0.002|TWO_SIDED|95.0|0.5|2.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||2.2|0.5|0.002
71128784|NCT00746863|141762831|SUPERIORITY_OR_OTHER|||||||0.435||95.0||||A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.|Wilcoxon (Mann-Whitney)|||A t-test was used in comparing the intervention and control groups, if continuous variables were approximately normal. If data were not approximately normal, a Mann-Whitney Wilcoxon test was used in comparing the two groups. Normality of continuous variables was assessed using the Shapiro-Wilk test. For categorical data, Fisher's exact test was used to evaluate the data. A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.||||0.435
71128785|NCT01504841|141762841|OTHER||%|36.4|||||TWO_SIDED|95.0|10.9|69.2|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I, percentage of participants who experienced a grade 3+ AE.|||69.2|10.9|
71128786|NCT01504841|141762841|OTHER||%|100.0|||||TWO_SIDED|95.0|39.8|100.0|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II, percentage of participants who experienced a grade 3+ AE.|||100|39.8|
71128787|NCT01504841|141762844|OTHER||%|18.2|||||TWO_SIDED|95.0|2.5|51.8|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I, percentage of participants who experienced a grade 3+ AE at least possibly related to study medications.|||51.8|2.5|
71128788|NCT01504841|141762844|OTHER||%|0.0|||||TWO_SIDED|95.0|0.0|60.2|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II, percentage of participants who experienced a grade 3+ AE at least possibly related to study medication.|||60.2|0|
71128789|NCT01504841|141762845|OTHER||%|18.2|||||TWO_SIDED|95.0|2.3|51.8|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 24, percentage of participants who experienced Virologic Failure.|Week 24 time point.||51.8|2.3|
71128790|NCT01504841|141762845|OTHER||%|25.0|||||TWO_SIDED|95.0|0.6|80.6|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 24, percentage of participants who experienced Virologic Failure.|Week 24 time point.||80.6|0.6|
71128791|NCT01504841|141762845|OTHER||%|27.3|||||TWO_SIDED|95.0|6.0|61.0|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 48, percentage of participants who experienced Virologic Failure.|Week 48 time point.||61|6|
71128792|NCT01504841|141762845|OTHER||%|75.0|||||TWO_SIDED|95.0|19.4|99.4|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 48, percentage of participants who experienced Virologic Failure.|Week 48 time point.||99.4|19.4|
71128793|NCT01504841|141762849|OTHER||%|9.1|||||TWO_SIDED|95.0|0.2|41.3|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 12, percentage of participants with a \>5% decline in absolute CD4 %.|Week 12 time point.||41.3|0.2|
71128794|NCT01504841|141762849|OTHER||%|50.0|||||TWO_SIDED|95.0|6.8|93.2|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 12, percentage of participants with a \>5% decline in absolute CD4 %.|Week 12 time point.||93.2|6.8|
71128795|NCT01504841|141762849|OTHER||%|9.1|||||TWO_SIDED|95.0|0.2|41.3|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 24, percentage of participants with a \>5% decline in absolute CD4 %.|Week 24 time point.||41.3|0.2|
71128796|NCT01504841|141762849|OTHER||%|25.0|||||TWO_SIDED|95.0|0.6|80.6|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 24, percentage of participants with a \>5% decline in absolute CD4 %.|Week 24 time point.||80.6|0.6|
71128797|NCT01504841|141762849|OTHER||%|18.2|||||TWO_SIDED|95.0|2.3|51.8|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 48, percentage of participants with a \>5% decline in absolute CD4 %.|Week 48 time point.||51.8|2.3|
71128798|NCT01504841|141762849|OTHER||%|50.0|||||TWO_SIDED|95.0|6.8|93.2|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 48, percentage of participants with a \>5% decline in absolute CD4 %.|Week 48 time point.||93.2|6.8|
71128799|NCT01496469|141762879|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.3||||0.882|TWO_SIDED|95.0|-3.9|3.4||Analysis of covariance (ANCOVA) model with treatment as a factor, and the baseline value and prior use of an ARB or an ACEi as covariates.|ANCOVA|||A total of 120 enrolled participants (60 participants per treatment group) was sufficient to achieve 80 percent (%) power to detect a difference of 6.0 mmHg between the placebo and febuxostat 80 mg treatment groups by a 2 sample t-test of the mean change from Baseline at Week 6 in 24-hour mean ambulatory SBP with a 2-sided significance level of 5%.||3.4|-3.9|0.882
71128800|NCT01496469|141762880|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.6||||0.613|TWO_SIDED|95.0|-1.9|3.2||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment as a factor, and the baseline value and prior use of an ARB or an ACEi as covariates.||3.2|-1.9|0.613
71128801|NCT01496469|141762881|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.4|||<|0.001|TWO_SIDED|95.0|-3.9|-2.9||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment as a factor, and the baseline value and prior use of an ARB or an ACEi as covariates.||-2.9|-3.9|<0.001
70946768|NCT03672175|141393947|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9085|TWO_SIDED|95.0|0.56|1.66||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 42||1.66|0.56|0.9085
70858520|NCT02751931|141202996|OTHER||Mean Difference (Net)|2.14|||<|0.001|TWO_SIDED|95.0|1.1|3.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||3.2|1.1|<0.001
70858521|NCT02751931|141202997|OTHER||Mean Difference (Net)|2.04||||0.352|TWO_SIDED|95.0|-2.4|6.49||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||6.49|-2.40|0.352
70858522|NCT02751931|141202997|OTHER||Mean Difference (Net)|-4.9||||0.127|TWO_SIDED|95.0|-11.34|1.53||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||1.53|-11.34|0.127
70858523|NCT02751931|141202997|OTHER||Mean Difference (Net)|1.3||||0.613|TWO_SIDED|95.0|-3.96|6.57||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||6.57|-3.96|0.613
70858524|NCT02751931|141202997|OTHER||Mean Difference (Net)|-6.79||||0.056|TWO_SIDED|95.0|-13.78|0.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||0.20|-13.78|0.056
70858525|NCT02751931|141202998|OTHER||Mean Difference (Net)|0.36||||0.153|TWO_SIDED|95.0|-0.14|0.86||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||0.86|-0.14|0.153
70858526|NCT02751931|141202998|OTHER||Mean Difference (Net)|0.64||||0.007|TWO_SIDED|95.0|0.19|1.08||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||1.08|0.19|0.007
70858527|NCT02751931|141202998|OTHER||Mean Difference (Net)|0.42||||0.106|TWO_SIDED|95.0|-0.1|0.93||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||0.93|-0.10|0.106
70858528|NCT02751931|141202998|OTHER||Mean Difference (Net)|0.95||||0.003|TWO_SIDED|95.0|0.38|1.51||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||1.51|0.38|0.003
70858529|NCT02380690|141203013|SUPERIORITY|ECLIPSE was powered to detect an effect size of 0.45.||||||0.981||||||Statistical significance was set at p\<0.05|Regression, Linear|||||||0.981
70858530|NCT02380690|141203014|SUPERIORITY|||||||0.774|||||||Regression, Linear|||||||0.774
70858531|NCT02380690|141203015|SUPERIORITY|Power was based on primary outcome.||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.546.|Regression, Linear|||||||0.999
70858532|NCT02380690|141203016|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.403.|Regression, Linear|||||||0.999
71128802|NCT01357551|141762899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.61|STANDARD_ERROR_OF_MEAN|0.78||0.04|TWO_SIDED|95.0|0.07|3.13||A priori threshold was p\<.05|Mixed Models Analysis|Parameters included common intercept, initial weight loss stratum, dummy-coded time, and indicators for the maintenance X each follow-up time point||The sample size estimate was based on the primary hypothesis that patients randomized to receive the maintenance intervention would have less mean weight regain at week 56 than those randomized to usual care. The week 0 standard deviation was estimated as 24.6kg, the correlation between week 0 and week 56 as 0.95, and the week 56 dropout rate as 10%. To detect a difference of 3.5 kg with 90% power and a type I error rate of 5%, 230 total (115 in each group) randomized patients were needed.||3.13|.07|.04
71128803|NCT01357551|141762900|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-125.49|STANDARD_ERROR_OF_MEAN|78.64||0.11|TWO_SIDED|95.0|-280.71|29.72|||Mixed Models Analysis|Common intercept, initial weight loss stratum, indicators for week 26 \& 56, group X time interaction||The hypothesis was that patients randomized to receive the maintenance intervention would have less caloric intake at week 56 than those randomized to usual care.||29.72|-280.71|.11
71128804|NCT01357551|141762901|SUPERIORITY_OR_OTHER||incidence rate ratio|1.03|STANDARD_ERROR_OF_MEAN|0.26||0.91|TWO_SIDED|95.0|0.63|1.68|||Mixed Models Analysis|Common intercept, initial weight loss stratum, indicators for week 26 \& 56, group X time interaction; negative binomial distribution with log link||The hypothesis was that patients randomized to receive the maintenance intervention would have higher rates of walking per week at week 56 than those randomized to usual care.||1.68|0.63|.91
71128805|NCT01357551|141762902|SUPERIORITY_OR_OTHER||incidence rate ratio|1.07|STANDARD_ERROR_OF_MEAN|0.35||0.83|TWO_SIDED|95.0|0.57|2.03|||Mixed Models Analysis|Common intercept, initial weight loss stratum, indicators for week 26 \& 56, group X time interaction; negative binomial distribution with log link||The hypothesis was that patients randomized to receive the maintenance intervention would have higher rates of moderate physical activity per week at week 56 than those randomized to usual care.||2.03|0.57|.83
71128806|NCT00774800|141762903|SUPERIORITY_OR_OTHER||Geometric Least Squares Means Ratio|1.54||||0.0011||||||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.||||0.0011
71128807|NCT00774800|141762903|SUPERIORITY_OR_OTHER||Geometric Least Squares Means Ratio|3.06|||<|0.0001||||||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.||||<0.0001
71128808|NCT00774800|141762904|SUPERIORITY_OR_OTHER||Geometric Least Squares Means Ratio|1.35||||0.0057||||||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.||||0.0057
71128809|NCT00774800|141762904|SUPERIORITY_OR_OTHER||Geometric Least Squares Means Ratio|1.66|||<|0.0001||||||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.||||<0.0001
71128810|NCT00774800|141762905|SUPERIORITY_OR_OTHER||Least Squares Means Difference|-18.33|||<|0.0001||||||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.||||<0.0001
71128811|NCT00774800|141762905|SUPERIORITY_OR_OTHER||Least Squares Means Difference|-62.46||||0.0018|||||||ANOVA|Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.||||0.0018
71128812|NCT04569357|141762943|SUPERIORITY|||||||0.0199|||||||Fisher Exact|||Test for comparison percentage of patients with reduction ≥ 25%.||||0.0199
71128813|NCT04569357|141762944|SUPERIORITY|||||||0.0096|||||||Wilcoxon (Mann-Whitney)|||Mean changes of ADHD-RS-V scores after 8 weeks of treatment were compared.||||0.0096
70858533|NCT02380690|141203017|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.452.|Regression, Linear|||||||0.999
70858534|NCT02380690|141203018|SUPERIORITY|||||||0.98||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.243.|Regression, Linear|||||||0.980
71128814|NCT04569357|141762945|SUPERIORITY|||||||0.0063|||||||Wilcoxon (Mann-Whitney)|||Mean changes of ADHD-RS-V scores (attention deficit subscale) after 8 weeks of treatment were compared.||||0.0063
71128815|NCT04569357|141762946|SUPERIORITY|||||||0.0525|||||||Wilcoxon (Mann-Whitney)|||Mean changes of ADHD-RS-V scores (hyperactivity/impulsivity subscale) after 8 weeks of treatment were compared.||||0.0525
71128816|NCT04569357|141762947|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||Therapeutic effect analysis.||||0.0024
70858535|NCT02380690|141203019|SUPERIORITY|||||||0.864||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.133.|Regression, Linear|||||||0.864
71128817|NCT04569357|141762947|SUPERIORITY|||||||0.1722|||||||Wilcoxon (Mann-Whitney)|||Side effects analysis.||||0.1722
71128818|NCT04569357|141762947|SUPERIORITY|||||||0.0012|||||||Wilcoxon (Mann-Whitney)|||Efficacy index analysis.||||0.0012
71128819|NCT04569357|141762948|SUPERIORITY|||||||0.13||||||"The p-value associated with treatment\*visit interaction of changes from baseline visit 1 to visit 2 and 3 endpoint between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.13
71128820|NCT04569357|141762949|SUPERIORITY|||||||0.81||||||"The p-value associated with treatment\*visit interaction of changes from baseline visit 1 to visit 2 and 3 endpoint between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||This analysis applies to Systolic pressure data.||||0.81
70858536|NCT02380690|141203020|SUPERIORITY|||||||0.78||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.102.|Regression, Linear|||||||0.780
71128821|NCT04569357|141762949|SUPERIORITY|||||||0.22||||||"The p-value associated with treatment\*visit interaction of changes from baseline visit 1 to visit 2 and 3 endpoint between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||This analysis applies to Diastolic pressure data.||||0.22
70858537|NCT02380690|141203021|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.536.|Regression, Linear|||||||0.999
70858538|NCT02380690|141203022|SUPERIORITY|||||||0.997||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.340.|Regression, Linear|||||||0.997
71128822|NCT04569357|141762950|SUPERIORITY|||||||0.13||||||"The p-value associated with treatment\*visit interaction of changes from baseline visit 1 to visit 2 and 3 endpoint between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.13
71128823|NCT04569357|141762951|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.2
71128824|NCT04569357|141762952|SUPERIORITY|||||||0.62|||||||Fisher Exact|||||||0.62
71128825|NCT04569357|141762953|SUPERIORITY|||||||0.5|||||||Fisher Exact|||||||0.5
71128826|NCT04569357|141762954|SUPERIORITY|||||||0.0254|||||||Fisher Exact|||||||0.0254
71128827|NCT01853878|141762965|EQUIVALENCE|P-value of the Wald test from a Cox regression model to test H0 = { HR=1} (Y = Time to Event)|Hazard Ratio (HR)|4.592||||0.1422|TWO_SIDED|95.0|0.6|35.167|||Regression, Cox|||Estimates of Hazard Ratio (HR) and their 95% Confidence Interval (CI) were obtained by Cox regression modelling.The Likelihood ratio test was used to compare the groups. The Cox proportional hazard regression was stratified by previous treatment \[Chemotherapy (CT) vs. no-CT\] and disease stage.||35.167|0.600|0.1422
71128828|NCT02161757|141762975|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate ratio|0.93||||0.5859|TWO_SIDED|95.0|0.72|1.21|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate ratio): Tralo 300 mg Q2W vs placebo.||1.21|0.72|0.5859
71128829|NCT02161757|141762975|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate ratio|0.9||||0.4406|TWO_SIDED|95.0|0.7|1.17|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate ratio): Tralo 300 mg Q4W vs placebo.||1.17|0.70|0.4406
70858539|NCT02380690|141203023|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.384.|Regression, Linear|||||||0.999
70858540|NCT02380690|141203024|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.730.|Regression, Linear|||||||0.999
71128830|NCT02161757|141762975|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate reduction|7.01||||0.5859|TWO_SIDED|95.0|-20.76|28.39|||Negative binominal||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate reduction): Tralo 300 mg Q2W vs placebo.||28.39|-20.76|0.5859
70858541|NCT02380690|141203025|SUPERIORITY|||||||0.914||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.161.|Regression, Linear|||||||0.914
70858542|NCT02380690|141203026|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.930.|Regression, Linear|||||||0.999
70858543|NCT02380690|141203027|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.379.|Regression, Linear|||||||0.999
70858544|NCT02380690|141203028|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.969.|Regression, Linear|||||||0.999
70858545|NCT04030026|141203062|SUPERIORITY||Geometric Mean Ratio|0.32|||<|0.0001|TWO_SIDED|95.0|0.208|0.431||Mixed-effects model: unstructured, heterogeneous toeplitz and autoregressive covariance matrices. Dependent variable: change from baseline in log-transformed scale of Daytime Cough Frequency. Fixed effects: sequence (arm), period and treatment.|Mixed-effects model|||||0.431|0.208|< 0.0001
71128831|NCT02161757|141762975|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate reduction|9.76||||0.4406|TWO_SIDED|95.0|-17.16|30.5|||Negative binominal||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate reduction): Tralo 300 mg Q4W vs placebo.||30.50|-17.16|0.4406
71128832|NCT02161757|141762976|SUPERIORITY||Least square (LS) Mean difference|6.03|||||TWO_SIDED|95.0|2.34|9.73|||||Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of percent change from baseline in pre-dose/pre-BD FEV1 at Week 52: Tralo 300 mg Q2W vs placebo.~Restricted maximum likelihood (REML) based repeated measures analysis performed on patients with a baseline pre-dose/pre-BD FEV1 assessment."||9.73|2.34|
71128833|NCT02161757|141762976|SUPERIORITY||LS Mean difference|2.1|||||TWO_SIDED|95.0|-1.58|5.77|||||Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of percent change from baseline in pre-dose/pre-BD FEV1 at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis performed on patients with a baseline pre-dose/pre-BD FEV1 assessment."||5.77|-1.58|
71128834|NCT02161757|141762977|SUPERIORITY||LS Mean difference|-0.09|||||TWO_SIDED|95.0|-0.23|0.04|||||Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in total asthma symptom score at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."||0.04|-0.23|
71128835|NCT02161757|141762977|SUPERIORITY||LS Mean difference|-0.02|||||TWO_SIDED|95.0|-0.15|0.12|||||Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in total asthma symptom score at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."||0.12|-0.15|
71128836|NCT02161757|141762978|SUPERIORITY||LS Mean difference|0.15|||||TWO_SIDED|95.0|-0.01|0.31|||||Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."||0.31|-0.01|
70858546|NCT04030026|141203064|SUPERIORITY||Geometric Mean Ratio|0.32|||<|0.0001|TWO_SIDED|95.0|0.208|0.431||Mixed-effects model: unstructured, heterogeneous toeplitz and autoregressive covariance matrices. Dependent variable: change from baseline in log-transformed scale of Daytime Cough Frequency. Fixed effects: sequence (arm), period and treatment.|Mixed-effects model|||||0.431|0.208|<0.0001
70858547|NCT04030026|141203065|SUPERIORITY||Geometric Mean Ratio|0.47||||0.0087|TWO_SIDED|95.0|0.23|0.717||Mixed-effects model: unstructured, heterogeneous toeplitz and autoregressive covariance matrices. Dependent variable: change from baseline in log-transformed scale of Daytime Cough Frequency. Fixed effects: sequence (arm), period and treatment.|Mixed-effects model|||||0.717|0.230|0.0087
70858548|NCT04030026|141203066|SUPERIORITY|||||||0.0014||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 9||||0.0014
70858549|NCT04030026|141203066|SUPERIORITY|||||||0.0001||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 16||||0.0001
70858550|NCT04030026|141203066|SUPERIORITY|||||||0.001||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 22||||0.001
70858551|NCT04030026|141203067|SUPERIORITY|||||||0.0198||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 9||||0.0198
71128837|NCT02161757|141762978|SUPERIORITY||LS Mean difference|0.12|||||TWO_SIDED|95.0|-0.03|0.28|||||Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."||0.28|-0.03|
71128838|NCT02161757|141762979|SUPERIORITY||LS Mean difference|-0.16|||||TWO_SIDED|95.0|-0.29|-0.02|||||Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for ACQ-6 at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."||-0.02|-0.29|
70858552|NCT04030026|141203067|SUPERIORITY|||||||0.0374||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 16||||0.0374
70858553|NCT04030026|141203067|SUPERIORITY|||||||0.2982||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 22||||0.2982
71128839|NCT02161757|141762979|SUPERIORITY||LS Mean difference|-0.12|||||TWO_SIDED|95.0|-0.26|0.01|||||Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for ACQ-6 at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."||0.01|-0.26|
71128840|NCT02161757|141762980|SUPERIORITY||Rate ratio|0.54||||0.0369|TWO_SIDED|95.0|0.3|0.96|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.|Comparison of AAER associated with an ER/UC visit or hospitalisation: Tralo 300 mg Q2W vs placebo.||0.96|0.30|0.0369
70858554|NCT04030026|141203068|SUPERIORITY|||||||0.0054||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo)|Student's T-test|||Change from baseline at Day 8||||0.0054
70858555|NCT04030026|141203068|SUPERIORITY||||||<|0.0001||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 15||||<0.0001
70946769|NCT03672175|141393947|SUPERIORITY||Odds Ratio (OR)|1.34||||0.3476|TWO_SIDED|95.0|0.73|2.44||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 182||2.44|0.73|0.3476
70946770|NCT03672175|141393947|SUPERIORITY||Odds Ratio (OR)|1.45||||0.206|TWO_SIDED|95.0|0.82|2.57||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 182||2.57|0.82|0.2060
71128841|NCT02161757|141762980|SUPERIORITY||Rate ratio|0.78||||0.3603|TWO_SIDED|95.0|0.46|1.33|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.|Comparison of AAER associated with an ER/UC visit or hospitalisation: Tralo 300 mg Q4W vs placebo.||1.33|0.46|0.3603
71128842|NCT02161757|141762982|SUPERIORITY||LS Mean difference|-0.11|||||TWO_SIDED|95.0|-0.51|0.29|||||Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of mean change from baseline in rescue medication use at Week 52: Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||0.29|-0.51|
71128843|NCT02161757|141762982|SUPERIORITY||LS Mean difference|-0.16|||||TWO_SIDED|95.0|-0.56|0.24|||||Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of mean change from baseline in rescue medication use at Week 52: Tralo 300 mg Q4W vs placebo. REML based repeated measures analysis.||0.24|-0.56|
71128844|NCT02161757|141762983|SUPERIORITY||LS Mean difference|6.25|||||TWO_SIDED|95.0|-3.53|16.03|||||Fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in morning PEF at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."||16.03|-3.53|
71128845|NCT02161757|141762983|SUPERIORITY||LS Mean difference|1.77|||||TWO_SIDED|95.0|-7.99|11.53|||||Fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in morning PEF at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."||11.53|-7.99|
71128846|NCT02161757|141762983|SUPERIORITY||LS Mean difference|7.14|||||TWO_SIDED|95.0|-2.6|16.87|||||Fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in evening PEF at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."||16.87|-2.60|
71128847|NCT02161757|141762983|SUPERIORITY||LS Mean difference|0.61|||||TWO_SIDED|95.0|-9.13|10.35|||||Fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in evening PEF at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."||10.35|-9.13|
71128848|NCT02161757|141762984|SUPERIORITY||LS Mean difference|-1.8|||||TWO_SIDED|95.0|-5.29|1.69|||||Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in number (%) of awakenings at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."||1.69|-5.29|
71128849|NCT02161757|141762984|SUPERIORITY||LS Mean difference|-2.36|||||TWO_SIDED|95.0|-5.84|1.12|||||Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in number (%) of awakenings at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."||1.12|-5.84|
71128850|NCT02161757|141762985|SUPERIORITY||Odds Ratio (OR)|0.95||||0.732|TWO_SIDED|95.0|0.71|1.28|||Cochran-Mantel-Haenszel||The estimate of each odds ratio was obtained from two separate models, from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.|Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: Tralo 300 mg Q2W vs placebo.||1.28|0.71|0.732
71128851|NCT02161757|141762985|SUPERIORITY||Odds Ratio (OR)|0.88||||0.421|TWO_SIDED|95.0|0.65|1.19|||Cochran-Mantel-Haenszel||The estimate of each odds ratio was obtained from two separate models, from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.|Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: Tralo 300 mg Q4W vs placebo.||1.19|0.65|0.421
71128852|NCT01399866|141762994|SUPERIORITY|||||||0.574|||||||ANOVA|||||||0.574
71128853|NCT01399866|141762994|SUPERIORITY|||||||0.747|||||||ANOVA|||||||0.747
71128854|NCT01399866|141762995|SUPERIORITY|||||||0.94|||||||ANOVA|||||||0.94
71128855|NCT01399866|141762996|SUPERIORITY|||||||0.818|||||||ANOVA|||||||0.818
71128856|NCT01399866|141762997|SUPERIORITY|||||||0.123|||||||ANOVA|||||||0.123
71128857|NCT01399866|141762998|SUPERIORITY|||||||0.473|||||||t-test, 2 sided|||||||0.473
70858556|NCT04030026|141203068|SUPERIORITY|||||||0.0001||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 21||||0.0001
70946771|NCT03672175|141393948|SUPERIORITY||Odds Ratio (OR)|1.05||||0.8303|TWO_SIDED|95.0|0.67|1.65||GEE for binary response model, with factors for treatment, CGI-S BL score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||||1.65|0.67|0.8303
70946772|NCT03672175|141393948|SUPERIORITY||Odds Ratio (OR)|1.43||||0.1199|TWO_SIDED|95.0|0.91|2.24||GEE for binary response model, with factors for treatment, CGI-S BL score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||||2.24|0.91|0.1199
70946773|NCT03672175|141393949|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.71||0.5021|TWO_SIDED|95.0|-1.9|0.9||MMRM with treatment, BL HAM-A total score, anti-depressant use at BL (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||||0.9|-1.9|0.5021
71128858|NCT00767819|141762999|SUPERIORITY|The lower limit of the confidence interval was used to support the decision in favor of p0 or p1: if the lower limit of the confidence interval overlapped p0, the hypothesis that p is greater than or equal to p1 could be rejected; on the other side, if the lower limit of the confidence interval excluded p0, the hypothesis that p is greater than or equal to p1 could be accepted.|percentage of participants|40.5||||0.1|TWO_SIDED|80.0|29.5|52.4|||Clopper-Person confidence interval|||||52.4|29.5|0.1
71128859|NCT03916081|141763019|SUPERIORITY||LS Mean Difference vs Vehicle|-1.18||||0.356|TWO_SIDED|95.0|-2.983|0.619||MMRM = mixed effects model for repeated measures vIGA-AD = validated Investigator Global Assessment scale for Atopic Dermatitis|MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from Baseline in Week 4 EASI Total Score: Roflumilast Cream 0.05% vs. Vehicle Cream||0.619|-2.983|0.356
71128860|NCT03916081|141763019|SUPERIORITY||LS Mean Difference vs Vehicle|-1.6||||0.097|TWO_SIDED|95.0|-3.382|0.178|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from Baseline in Week 4 EASI Total Score: Roflumilast Cream 0.15% vs. Vehicle Cream||0.178|-3.382|0.097
71128861|NCT03916081|141763020|SUPERIORITY||LS Mean Difference|-11.37||||0.248|TWO_SIDED|95.0|-26.789|4.044|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Percent Change from Baseline in Week 1 EASI Total Score: Roflumilast Cream 0.05% vs. Vehicle Cream||4.044|-26.789|0.248
71128862|NCT03916081|141763020|SUPERIORITY||LS Mean Difference|-10.28||||0.349|TWO_SIDED|95.0|-25.666|5.114|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Percent Change from Baseline in Week 1 EASI Total Score: Roflumilast Cream 0.15% vs. Vehicle Cream||5.114|-25.666|0.349
71128863|NCT03916081|141763020|SUPERIORITY||LS Mean Difference|-5.82||||0.912|TWO_SIDED|-22.52|-22.52|10.88|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Percent Change from Baseline in Week 2 EASI Total Score: Roflumilast Cream 0.05% vs. Vehicle Cream||10.880|-22.520|0.912
71128864|NCT03916081|141763020|SUPERIORITY||LS Mean Difference|-9.17||||0.548|TWO_SIDED|95.0|-25.686|7.341|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Percent Change from Baseline in Week 2 EASI Total Score: Roflumilast Cream 0.15% vs. Vehicle Cream||7.341|-25.686|0.548
71128865|NCT03916081|141763020|SUPERIORITY||LS Mean Difference|-13.53||||0.164|TWO_SIDED|95.0|-30.157|3.097|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Percent Change from Baseline in Week 4 EASI Total Score: Roflumilast Cream 0.05% vs. Vehicle Cream||3.097|-30.157|0.164
70946774|NCT03672175|141393949|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.7||0.2868|TWO_SIDED|95.0|-2.1|0.6||MMRM with treatment, BL HAM-A total score, anti-depressant use at BL (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||||0.6|-2.1|0.2868
70946775|NCT03672175|141393950|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.35||0.5987|TWO_SIDED|95.0|-3.4|1.9||MMRM with treatment, BL MADRS total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||||1.9|-3.4|0.5987
70946776|NCT03672175|141393950|SUPERIORITY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.36||0.1443|TWO_SIDED|95.0|-4.7|0.7||MMRM with treatment, BL MADRS total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||||0.7|-4.7|0.1443
71128866|NCT03916081|141763020|SUPERIORITY||LS Mean Difference|-16.48||||0.049|TWO_SIDED|95.0|-32.921|-0.048|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Percent Change from Baseline in Week 4 EASI Total Score: Roflumilast Cream 0.15% vs. Vehicle Cream||-0.048|-32.921|0.049
71128867|NCT03916081|141763021|SUPERIORITY||LS Mean Difference|-0.92||||0.44|TWO_SIDED|95.0|-2.412|0.568|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from Baseline in Week 1 EASI Total Score: Roflumilast Cream 0.05% vs. Vehicle Cream||0.568|-2.412|0.440
71128868|NCT03916081|141763021|SUPERIORITY||LS Mean Difference|-0.57||||0.875|TWO_SIDED|95.0|-2.061|0.914|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from Baseline in Week 1 EASI Total Score: Roflumilast Cream 0.15% vs. Vehicle Cream||0.914|-2.061|0.875
71128869|NCT03916081|141763022|SUPERIORITY|||||||0.352|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-50 at Week 1: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.352
71128870|NCT03916081|141763022|SUPERIORITY|||||||0.803|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-50 at Week 1: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.803
70946777|NCT03672175|141393951|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.87||0.8499|TWO_SIDED|95.0|-3.3|4.0||MMRM with treatment, BL HAM-D core subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||4.0|-3.3|0.8499
70946778|NCT03672175|141393951|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.88||0.6265|TWO_SIDED|95.0|-4.6|2.8||MMRM with treatment, BL HAM-D core subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||2.8|-4.6|0.6265
71128871|NCT03916081|141763022|SUPERIORITY|||||||0.25|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-50 at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.250
71128872|NCT03916081|141763022|SUPERIORITY|||||||0.756|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-50 at Week 2: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.756
71128873|NCT03916081|141763022|SUPERIORITY|||||||0.097|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-50 at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.097
71128874|NCT03916081|141763022|SUPERIORITY|||||||0.054|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-50 at Week 4: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.054
71128875|NCT03916081|141763023|SUPERIORITY|||||||0.178|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-75 at Week 1: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.178
71128876|NCT03916081|141763023|SUPERIORITY|||||||0.046|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-75 at Week 1: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.046
71128877|NCT03916081|141763023|SUPERIORITY|||||||0.469|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-75 at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.469
71128878|NCT03916081|141763023|SUPERIORITY|||||||0.446|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-75 at Week 2: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.446
71128879|NCT03916081|141763023|SUPERIORITY|||||||0.009|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-75 at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.009
70946779|NCT03672175|141393951|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.97||0.7418|TWO_SIDED|95.0|-3.2|4.5||MMRM with treatment, BL HAM-D core subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||4.5|-3.2|0.7418
70858557|NCT04030026|141203069|SUPERIORITY|||||||0.0107||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 9||||0.0107
70858558|NCT04030026|141203069|SUPERIORITY|||||||0.0051||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change for baseline at Day 16||||0.0051
70858559|NCT04030026|141203069|SUPERIORITY|||||||0.1513||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 22||||0.1513
70858560|NCT04030026|141203070|SUPERIORITY|||||||0.3601||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||||||0.3601
70946780|NCT03672175|141393951|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.94||0.7837|TWO_SIDED|95.0|-4.3|3.3||MMRM with treatment, BL HAM-D core subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||3.3|-4.3|0.7837
71128880|NCT03916081|141763023|SUPERIORITY|||||||0.045|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-75 at Week 4: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.045
70858561|NCT00282347|141203082|SUPERIORITY_OR_OTHER|||||||0.5538|TWO_SIDED||||||Stratified Wilcoxon-Rank Sum Test|||||||0.5538
71128881|NCT03916081|141763024|SUPERIORITY|||||||0.317|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-90 at Week 1: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.317
71128882|NCT03916081|141763024|SUPERIORITY|||||||0.182|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-90 at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.182
71128883|NCT03916081|141763024|SUPERIORITY|||||||0.485|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-90 at Week 2: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.485
71128884|NCT03916081|141763024|SUPERIORITY|||||||0.913|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-90 at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.913
71128885|NCT03916081|141763024|SUPERIORITY|||||||0.288|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-90 at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.288
71128886|NCT03916081|141763025|SUPERIORITY|||||||0.34|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-100 at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.340
71128887|NCT03916081|141763025|SUPERIORITY|||||||0.146|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-100 at Week 2: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.146
71128888|NCT03916081|141763025|SUPERIORITY|||||||0.967|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-100 at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.967
71128889|NCT03916081|141763025|SUPERIORITY|||||||0.088|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-100 at Week 4: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.088
71128890|NCT03916081|141763026|SUPERIORITY||LS Mean Difference|0.38||||0.989|TWO_SIDED|95.0|-1.098|1.852|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline BSA as a covariate.|Change from Baseline in BSA Affected at Week 1: Roflumilast Cream 0.05% vs. Vehicle Cream||1.852|-1.098|0.989
71128891|NCT03916081|141763026|SUPERIORITY||LS Mean Difference|-0.1|||>|0.999|TWO_SIDED|95.0|-1.566|1.367|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline BSA as a covariate.|Change from Baseline in BSA Affected at Week 1: Roflumilast Cream 0.15% vs. Vehicle Cream||1.367|-1.566|>0.999
71128892|NCT03916081|141763026|SUPERIORITY||LS Mean Difference|0.6||||0.966|TWO_SIDED|95.0|-1.51|2.702|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline BSA as a covariate.|Change from Baseline in BSA Affected at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||2.702|-1.510|0.966
71128893|NCT03916081|141763026|SUPERIORITY||LS Mean Difference|-0.34||||0.999|TWO_SIDED|95.0|-2.415|1.744|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline BSA as a covariate.|Change from Baseline in BSA Affected at Week 2: Roflumilast Cream 0.15% vs. Vehicle Cream||1.744|-2.415|0.999
71128894|NCT03916081|141763026|SUPERIORITY||LS Mean Difference|-0.25|||>|0.999|TWO_SIDED|95.0|-2.624|2.119|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline BSA as a covariate.|Change from Baseline in BSA Affected at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||2.119|-2.624|>0.999
71128895|NCT03916081|141763026|SUPERIORITY||LS Mean Difference|-0.94||||0.798|TWO_SIDED|95.0|-3.285|1.398|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline BSA as a covariate.|Change from Baseline in BSA Affected at Week 4: Roflumilast Cream 0.15% vs. Vehicle Cream||1.398|-3.285|0.798
71128896|NCT03916081|141763027|SUPERIORITY||LS Mean Difference|-0.78||||0.466|TWO_SIDED|95.0|-2.075|0.506|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline WI-NRS as a covariate.|Change from Baseline in WI-NRS at Week 1: Roflumilast Cream 0.05% vs. Vehicle Cream||0.506|-2.075|0.466
71128897|NCT03916081|141763027|SUPERIORITY||LS Mean Difference|-1.03||||0.18|TWO_SIDED|95.0|-2.322|0.255|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline WI-NRS as a covariate.|Change from Baseline in WI-NRS at Week 1: Roflumilast Cream 0.15% vs. Vehicle Cream||0.255|-2.322|0.180
71128898|NCT03916081|141763027|SUPERIORITY||LS Mean Difference|-0.43||||0.967|TWO_SIDED|95.0|-1.921|1.069|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline WI-NRS as a covariate.|Change from Baseline in WI-NRS at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||1.069|-1.921|0.967
71128899|NCT03916081|141763027|SUPERIORITY||LS Mean Difference|-0.72||||0.684|TWO_SIDED|95.0|-2.205|0.762|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline WI-NRS as a covariate.|Change from Baseline in WI-NRS at Week 2: Roflumilast Cream 0.15% vs. Vehicle Cream||0.762|-2.205|0.684
70858562|NCT04480424|141203156|SUPERIORITY||Risk Difference|-4.0||||0.8275|TWO_SIDED|95.0|-22.3|14.5||p-value was calculated using Fisher's exact method with 5% level of significance to test the null hypothesis of no difference in mortality rate between the two treatment groups.|Fisher Exact|||||14.5|-22.3|0.8275
70858563|NCT04480424|141203157|SUPERIORITY|||||||0.8599||||||p-value was calculated using Gray's test for equality of the Cumulative Incidence Function (CIF) between treatment groups.|Gray's test|||||||0.8599
70858564|NCT04480424|141203158|SUPERIORITY||Least Square Mean (LSM) Difference|2.58||||0.2626|TWO_SIDED|95.0|-1.96|7.12||p-value was calculated using an Analysis of Variance (ANOVA) model, including the number of days on mechanical ventilation as a dependent variable and treatment group as a fixed effect.|ANOVA|||||7.12|-1.96|0.2626
70858565|NCT04480424|141203159|SUPERIORITY|||||||0.6854||||||p-value was calculated using Gray's test for equality of the CIF between treatment groups.|Gray's test|||||||0.6854
70858566|NCT04480424|141203160|SUPERIORITY||LSM Difference|-0.02||||0.9917|TWO_SIDED|95.0|-3.82|3.78||95% CI for difference in least square mean (LSM) between treatment groups and the associated p-value were calculated using an ANOVA model, including the number of days on oxygen as a dependent variable and treatment group as a fixed effect.|ANOVA|||||3.78|-3.82|0.9917
70858567|NCT04480424|141203161|SUPERIORITY||LSM Difference|0.05||||0.7557|TWO_SIDED|95.0|-0.29|0.4|||Kenward-Roger|p-value were calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.||||0.40|-0.29|0.7557
70858568|NCT04480424|141203162|SUPERIORITY||LSM Difference|0.4||||0.0922|TWO_SIDED|95.0|-0.07|0.86||p-value were calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Kenward-Roger|||||0.86|-0.07|0.0922
70858569|NCT04480424|141203166|SUPERIORITY||Kenward-Roger|0.4||||0.3611|TWO_SIDED|95.0|-0.47|1.28||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|LSM Difference|||||1.28|-0.47|0.3611
70858570|NCT04480424|141203166|SUPERIORITY||Kenward-Roger|-0.1||||0.9238|TWO_SIDED|95.0|-2.13|1.94||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|LSM Difference|||||1.94|-2.13|0.9238
70858571|NCT04480424|141203166|SUPERIORITY||Kenward-Roger|0.08||||0.9541|TWO_SIDED|95.0|-2.58|2.73||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|LSM Difference|||||2.73|-2.58|0.9541
70858572|NCT04480424|141203167|SUPERIORITY||LSM Difference|0.06||||0.9366|TWO_SIDED|95.0|-1.42|1.53||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|LSM Difference|||||1.53|-1.42|0.9366
70858573|NCT00734747|141203192|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<.001
70858574|NCT01850602|141203228|NON_INFERIORITY|"Non-Inferiority margin: 1.0 mg/dL~Non-Inferiority was considerd to be confirmed if the upper limit of two-sided confidence interval became 1.0 mg/dL or less."|Mean Difference (Final Values)|-0.34||||0.02|TWO_SIDED|95.0|-0.63|-0.05|||ANCOVA|||||-0.05|-0.63|0.020
70858575|NCT01857310|141203232|SUPERIORITY||Risk Difference (RD)|-0.9|||||TWO_SIDED|95.0|-4.7|2.8|||||Adjusted for infertility treatment stratum and study site|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Live birth will be compared using two sided tests conducted at the 0.05 level."||2.8|-4.7|
70858576|NCT01857310|141203232|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.88|1.09|||||Adjusted for infertility treatment stratum and study site|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Live birth will be compared using two sided tests conducted at the 0.05 level."||1.09|0.88|
70946781|NCT03672175|141393952|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.74||0.6848|TWO_SIDED|95.0|-4.1|2.7||MMRM with treatment, BL HAM-D anxiety subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||2.7|-4.1|0.6848
71128900|NCT03916081|141763027|SUPERIORITY||LS Mean Difference|-0.61||||0.856|TWO_SIDED|95.0|-2.221|1.003|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline WI-NRS as a covariate.|Change from Baseline in WI-NRS at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||1.003|-2.221|0.856
71128901|NCT03916081|141763027|SUPERIORITY||LS Mean Difference|-0.51||||0.932|TWO_SIDED|95.0|-2.105|1.089|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline WI-NRS as a covariate.|Change from Baseline in WI-NRS at Week 4: Roflumilast Cream 0.15% vs. Vehicle Cream||1.089|-2.105|0.932
71128902|NCT03916081|141763028|SUPERIORITY|||||||0.637|||||||Cochran-Mantel-Haenszel|v-IGA-AD included as a stratification factor.||Number of Participants Achieving a ≥4-Point Improvement from Baseline WI-NRS at Week 1: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.637
71128903|NCT03916081|141763028|SUPERIORITY|||||||0.124|||||||Cochran-Mantel-Haenszel|v-IGA-AD included as a stratification factor.||Number of Participants Achieving a ≥4-Point Improvement from Baseline WI-NRS at Week 1: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.124
71128904|NCT03916081|141763028|SUPERIORITY|||||||0.196|||||||Cochran-Mantel-Haenszel|v-IGA-AD included as a stratification factor.||Number of Participants Achieving a ≥4-Point Improvement from Baseline WI-NRS at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.196
71128905|NCT03916081|141763028|SUPERIORITY|||||||0.985|||||||Cochran-Mantel-Haenszel|v-IGA-AD included as a stratification factor.||Number of Participants Achieving a ≥4-Point Improvement from Baseline WI-NRS at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.985
71128906|NCT03916081|141763028|SUPERIORITY|||||||0.401|||||||Cochran-Mantel-Haenszel|v-IGA-AD included as a stratification factor.||Number of Participants Achieving a ≥4-Point Improvement from Baseline WI-NRS at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.401
71128907|NCT03916081|141763028|SUPERIORITY|||||||0.996|||||||Cochran-Mantel-Haenszel|v-IGA-AD included as a stratification factor.||Number of Participants Achieving a ≥4-Point Improvement from Baseline WI-NRS at Week 4: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.996
71128908|NCT00847197|141763035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|2.1||0.926|TWO_SIDED|95.0|-3.9|4.3||The significance test was 2-tailed with α=0.05.|Mixed Models Analysis|The test for the treatment difference in terms of percentage change from baseline to a given time point was done using the contrast statement.||For the analysis of percent change from baseline in LDL-C at study endpoint, a Longitudinal Analysis of Covariance (ANCOVA) method was used. The repeated measures model included terms for treatment, time (Day 15, 29), and the interaction of time-by-treatment. The analysis model also adjusted for baseline, baseline-by-time interaction, region and gender.||4.3|-3.9|0.926
70946782|NCT03672175|141393952|SUPERIORITY||LS Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|1.72||0.11|TWO_SIDED|95.0|-6.1|0.6||MMRM with treatment, BL HAM-D anxiety subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||0.6|-6.1|0.1100
71128909|NCT00847197|141763036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6|STANDARD_ERROR_OF_MEAN|1.8||0.013|TWO_SIDED|95.0|1.0|8.1||The significance test was 2-tailed with α=0.05.|Mixed Models Analysis|The test for the treatment difference in terms of percentage change from baseline to a given time point was done using the contrast statement.||For the analysis of percent change from baseline in LDL-C at study endpoint, a Longitudinal Analysis of Covariance (ANCOVA) method was used. The repeated measures model included terms for treatment, time (Day 15, 29), and the interaction of time-by-treatment. The analysis model also adjusted for baseline, baseline-by-time interaction, region and gender.||8.1|1.0|0.013
71128910|NCT00847197|141763037|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-10.3|STANDARD_ERROR_OF_MEAN|8.6||0.02|TWO_SIDED|95.0|-18.9|-1.9|||Wilcoxon's Rank Sum Test|The significance test was 2-tailed with α=0.05.||Triglycerides was analyzed by non-parametric methods with terms for treatment, gender and region. Specifically, the analysis of variance (ANOVA) model was applied to the Tukey's normal scores of the percent change from baseline. The estimate of the difference in medians between MK1903 and the placebo groups utilizing the Hodges-Lehmann estimate and a distribution-free 95% CI for the difference based on Wilcoxon's rank sum test was provided.||-1.9|-18.9|0.02
71128911|NCT00622388|141763038|SUPERIORITY_OR_OTHER||Response rate|11.0|||||TWO_SIDED|95.0|5.0|20.0|||||Response rate is calculated as the number of responses divided by the number of participants treated, expressed as a percentage.|||20|5|
71128912|NCT00348309|141763053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.049|TWO_SIDED|95.0|-2.7|0.0||APOE4 negatives|Mixed Models Analysis|||||-0.0|-2.7|0.049
71128913|NCT00348309|141763053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.808|TWO_SIDED|95.0|-1.7|1.3||APOE4 negatives|Mixed Models Analysis|||||1.3|-1.7|0.808
71128914|NCT00348309|141763053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.035|TWO_SIDED|95.0|-1.9|-0.1||All except E4/E4s|Mixed Models Analysis|||||-0.1|-1.9|0.035
71128915|NCT00348309|141763053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.999|TWO_SIDED|95.0|-1.0|1.0||All except E4/E4s|Mixed Models Analysis|||||1.0|-1.0|0.999
71128916|NCT00348309|141763053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.02|TWO_SIDED|95.0|-1.9|-0.2||Full population|Mixed Models Analysis|||||-0.2|-1.9|0.020
71128917|NCT00348309|141763053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.661|TWO_SIDED|95.0|-1.2|0.7||Full population|Mixed Models Analysis|||||0.7|-1.2|0.661
71128918|NCT00348309|141763054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||=|0.056|TWO_SIDED|95.0|-1.0|0.0||APOE4 negatives|Mixed Models Analysis|||||0.0|-1.0|=0.056
71128919|NCT00348309|141763054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||=|0.587|TWO_SIDED|95.0|-0.4|0.7||APOE4 negatives|Mixed Models Analysis|||||0.7|-0.4|=0.587
71128920|NCT00348309|141763054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||=|0.004|TWO_SIDED|95.0|-0.9|-0.2||All except E4/E4s|Mixed Models Analysis|||||-0.2|-0.9|=0.004
71128921|NCT00348309|141763054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||=|0.402|TWO_SIDED|95.0|-0.2|0.6||All except E4/E4s|Mixed Models Analysis|||||0.6|-0.2|=0.402
71128922|NCT00348309|141763054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||=|0.002|TWO_SIDED|95.0|-0.9|-0.2||Full population|Mixed Models Analysis|||||-0.2|-0.9|=0.002
71128923|NCT00348309|141763054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||=|0.478|TWO_SIDED|95.0|-0.2|0.5||Full population|Mixed Models Analysis|||||0.5|-0.2|=0.478
70946783|NCT03672175|141393952|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.86||0.509|TWO_SIDED|95.0|-2.4|4.9||MMRM with treatment, BL HAM-D anxiety subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||4.9|-2.4|0.5090
71128924|NCT00348309|141763055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||=|0.34|TWO_SIDED|95.0|-2.0|0.7||Week 8|Mixed Models Analysis|||||0.7|-2.0|=0.340
71128925|NCT00348309|141763055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|||=|0.079|TWO_SIDED|95.0|-2.5|0.1||Week 8|Mixed Models Analysis|||||0.1|-2.5|=0.079
71128926|NCT00348309|141763055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||=|0.91|TWO_SIDED|95.0|-1.7|1.5||Week 16|Mixed Models Analysis|||||1.5|-1.7|=0.910
71128927|NCT00348309|141763055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.521|TWO_SIDED|95.0|-2.1|1.0||Week 16|Mixed Models Analysis|||||1.0|-2.1|0.521
71128928|NCT00348309|141763055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|||=|0.154|TWO_SIDED|95.0|-0.5|3.0||Week 24|Mixed Models Analysis|||||3.0|-0.5|=0.154
71128929|NCT00348309|141763055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||=|0.836|TWO_SIDED|95.0|-1.6|2.0||Week 24|Mixed Models Analysis|||||2.0|-1.6|=0.836
71128930|NCT00348309|141763055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1||||0.061|TWO_SIDED|95.0|-0.1|4.2||Week 48|Mixed Models Analysis|||||4.2|-0.1|0.061
71128931|NCT00348309|141763055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||=|0.566|TWO_SIDED|95.0|-2.9|1.6||Week 48|Mixed Models Analysis|||||1.6|-2.9|=0.566
71128932|NCT00348309|141763056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||=|0.414|TWO_SIDED|95.0|-1.3|0.5||Week 8|Mixed Models Analysis|||||0.5|-1.3|=0.414
71128933|NCT00348309|141763056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.931|TWO_SIDED|95.0|-1.0|1.1||Week 8|Mixed Models Analysis|||||1.1|-1.0|0.931
71128934|NCT00348309|141763056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.485|TWO_SIDED|95.0|-1.4|0.7||Week 16|Mixed Models Analysis|||||0.7|-1.4|0.485
71128935|NCT00348309|141763056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.55|TWO_SIDED|95.0|-0.8|1.5||Week 16|Mixed Models Analysis|||||1.5|-0.8|0.550
70946784|NCT03672175|141393952|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|1.77||0.8948|TWO_SIDED|95.0|-3.2|3.7||MMRM with treatment, BL HAM-D anxiety subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||3.7|-3.2|0.8948
71128936|NCT00348309|141763056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.264|TWO_SIDED|95.0|-1.8|0.5||Week 24|Mixed Models Analysis|||||0.5|-1.8|0.264
71128937|NCT00348309|141763056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.732|TWO_SIDED|95.0|-1.5|1.0||Week 24|Mixed Models Analysis|||||1.0|-1.5|0.732
71128938|NCT00348309|141763056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.043|TWO_SIDED|95.0|-2.9|0.0||Week 48|Mixed Models Analysis|||||-0.0|-2.9|0.043
71128939|NCT00348309|141763056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.814|TWO_SIDED|95.0|-1.4|1.8||Week 48|Mixed Models Analysis|||||1.8|-1.4|0.814
71128940|NCT00348309|141763057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.87|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||||0.6|-0.5|0.870
71128941|NCT00348309|141763057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.617|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||||0.4|-0.7|0.617
71128942|NCT00348309|141763058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.789|TWO_SIDED|95.0|-5.2|6.9|||Mixed Models Analysis|||Week 12 Q1||6.9|-5.2|0.789
70946785|NCT03672175|141393953|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|2.25||0.9591|TWO_SIDED|95.0|-4.5|4.3||MMRM with treatment, BL HAM-D Bech-6 subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||4.3|-4.5|0.9591
71128943|NCT00348309|141763058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.643|TWO_SIDED|95.0|-9.0|5.6||Week 12Q1|Mixed Models Analysis|||||5.6|-9.0|0.643
71128944|NCT00348309|141763058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.3||||0.052|TWO_SIDED|95.0|-14.7|0.1||Week 24 Q1|Mixed Models Analysis|||||0.1|-14.7|0.052
71128945|NCT00348309|141763058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7||||0.481|TWO_SIDED|95.0|-14.0|6.6||Week 24 Q1|Mixed Models Analysis|||||6.6|-14.0|0.481
71128946|NCT00348309|141763058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.2||||0.195|TWO_SIDED|95.0|-15.6|3.2||Week 36 Q1|Mixed Models Analysis|||||3.2|-15.6|0.195
71128947|NCT00348309|141763058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.857|TWO_SIDED|95.0|-12.9|10.7||Week 36 Q1|Mixed Models Analysis|||||10.7|-12.9|0.857
71128948|NCT00348309|141763058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6||||0.422|TWO_SIDED|95.0|-15.9|6.7||Week 48 Q1|Mixed Models Analysis|||||6.7|-15.9|0.422
71128949|NCT00348309|141763058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.562|TWO_SIDED|95.0|-15.7|8.6||Week 48 Q1|Mixed Models Analysis|||||8.6|-15.7|0.562
71128950|NCT00348309|141763058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.8||||0.129|TWO_SIDED|95.0|-2.6|20.2||Week 12 Q2|Mixed Models Analysis|||||20.2|-2.6|0.129
71128951|NCT00348309|141763058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9||||0.194|TWO_SIDED|95.0|-4.0|19.9||Week 12 Q2|Mixed Models Analysis|||||19.9|-4.0|0.194
71128952|NCT00348309|141763058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.832|TWO_SIDED|95.0|-10.5|13.1||Week 24 Q2|Mixed Models Analysis|||||13.1|-10.5|0.832
71128953|NCT00348309|141763058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1||||0.351|TWO_SIDED|95.0|-6.8|19.1||Week 24 Q2|Mixed Models Analysis|||||19.1|-6.8|0.351
71128954|NCT00348309|141763058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.949|TWO_SIDED|95.0|-13.3|12.5||Week 36 Q2|Mixed Models Analysis|||||12.5|-13.3|0.949
71128955|NCT00348309|141763058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.3||||0.253|TWO_SIDED|95.0|-6.0|22.6||Week 36 Q2|Mixed Models Analysis|||||22.6|-6.0|0.253
71128956|NCT00348309|141763058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.735|TWO_SIDED|95.0|-16.2|11.4||Week 48 Q2|Mixed Models Analysis|||||11.4|-16.2|0.735
71128957|NCT00348309|141763058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.2||||0.046|TWO_SIDED|95.0|0.3|32.0||Week 48 Q2|Mixed Models Analysis|||||32.0|0.3|0.046
71128958|NCT00348309|141763059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.914|TWO_SIDED|95.0|-2.3|2.0||Week 12 Thermometer|Mixed Models Analysis|||||2.0|-2.3|0.914
71128959|NCT00348309|141763059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.415|TWO_SIDED|95.0|-3.3|1.4||Week 12 Thermometer|Mixed Models Analysis|||||1.4|-3.3|0.415
71128960|NCT00348309|141763059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.063|TWO_SIDED|95.0|-4.9|0.1||Week 36 Thermometer|Mixed Models Analysis|||||0.1|-4.9|0.063
71128961|NCT00348309|141763059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9||||0.03|TWO_SIDED|95.0|-5.6|-0.3||Week 36 Thermometer|Mixed Models Analysis|||||-0.3|-5.6|0.030
71128962|NCT00348309|141763059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.392|TWO_SIDED|95.0|-1.5|3.8||Week 48 Thermometer|Mixed Models Analysis|||||3.8|-1.5|0.392
71128963|NCT00348309|141763059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.557|TWO_SIDED|95.0|-3.7|2.0||Week 48 Thermometer|Mixed Models Analysis|||||2.0|-3.7|0.557
71128964|NCT00348309|141763059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.32|TWO_SIDED|95.0|-0.01|0.03||Week 12 Utility|Mixed Models Analysis|||||0.03|-0.01|0.320
71128965|NCT00348309|141763059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.18|TWO_SIDED|95.0|-0.04|0.01||Week 12 Utility|Mixed Models Analysis|||||0.01|-0.04|0.180
71128966|NCT00348309|141763059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.498|TWO_SIDED|95.0|-0.02|0.04||Week 36 Utility|Mixed Models Analysis|||||0.04|-0.02|0.498
71128967|NCT00348309|141763059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.081|TWO_SIDED|95.0|-0.06|0.0||Week 36 Utility|Mixed Models Analysis|||||0.00|-0.06|0.081
71128968|NCT00348309|141763059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.077|TWO_SIDED|95.0|0.0|0.06||Week 48 Utility|Mixed Models Analysis|||||0.06|-0.00|0.077
71128969|NCT00348309|141763059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.64|TWO_SIDED|95.0|-0.04|0.03||Week 48 Utility|Mixed Models Analysis|||||0.03|-0.04|0.640
71128970|NCT00348309|141763060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.105|TWO_SIDED|95.0|-1.6|0.2|||ANCOVA|||||0.2|-1.6|0.105
71128971|NCT00348309|141763060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.483|TWO_SIDED|95.0|-1.3|0.6|||ANCOVA|||||0.6|-1.3|0.483
71128972|NCT00348309|141763061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.004|TWO_SIDED|95.0|-0.9|-0.2|||ANCOVA|||||-0.2|-0.9|0.004
71128973|NCT00348309|141763061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.554|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||||0.5|-0.3|0.554
71128974|NCT00348309|141763062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.292|TWO_SIDED|95.0|-0.3|1.1|||ANCOVA|||||1.1|-0.3|0.292
71128975|NCT00348309|141763062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.297|TWO_SIDED|95.0|-0.3|1.1|||ANCOVA|||||1.1|-0.3|0.297
71128976|NCT00348309|141763063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.598|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.598
71128977|NCT00348309|141763063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.073|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|0.073
71128978|NCT00348309|141763064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.006|TWO_SIDED|95.0|0.02|0.12|||ANCOVA|||||0.12|0.02|0.006
71128979|NCT00348309|141763064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.14|TWO_SIDED|95.0|-0.01|0.09|||ANCOVA|||||0.09|-0.01|0.140
71128980|NCT00348309|141763074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.027|TWO_SIDED|95.0|-1.2|-0.1||Week 12|Mixed Models Analysis|||||-0.1|-1.2|0.027
71128981|NCT00348309|141763074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.091|TWO_SIDED|95.0|-1.1|0.1||Week 12|Mixed Models Analysis|||||0.1|-1.1|0.091
71128982|NCT00348309|141763074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.268|TWO_SIDED|95.0|-1.1|0.3||Week 36|Mixed Models Analysis|||||0.3|-1.1|0.268
71128983|NCT00348309|141763074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.318|TWO_SIDED|95.0|-1.1|0.4||Week 36|Mixed Models Analysis|||||0.4|-1.1|0.318
71128984|NCT00348309|141763074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.03|TWO_SIDED|95.0|-1.6|-0.1||Week 48|Mixed Models Analysis|||||-0.1|-1.6|0.030
71128985|NCT00348309|141763074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.797|TWO_SIDED|95.0|-0.9|0.7||Week 48|Mixed Models Analysis|||||0.7|-0.9|0.797
71128986|NCT00223704|141763086|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||This P-value is for the main comparison of receiving any transfusion.|Chi-squared|||||||0.72
71128987|NCT00223704|141763087|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.88
71128988|NCT00223704|141763088|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.43
71128989|NCT00223704|141763089|SUPERIORITY_OR_OTHER|||||||0.92||95.0||||The P-value reflects the difference in Interleukin-6 concentrations among the 3 treatment groups over the course of the study (baseline, post-bypass, postoperative day 1 and 2)|Mixed Models Analysis|||The time course for Interleukin-6 concentrations were analyzed using mixed-effects models with fixed effects of drug treatment (placebo, aminocaproic acid, HOE 140) and time since randomization. We included a random subject effect and a first-order autoregressive process to account for the correlation in the response variable in the mixed-effects model||||0.92
71128990|NCT00223704|141763090|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value reflects the difference in D-dimer concentrations among the 3 treatment groups over the course of the study (baseline, 30min, 60min, post-bypass, and postoperative day 1)|Mixed Models Analysis|||The time course for D-dimer concentrations were analyzed using mixed-effects models with fixed effects of drug treatment (placebo, aminocaproic acid, HOE 140) and time since randomization. We included a random subject effect and a first-order autoregressive process to account for the correlation in the response variable in the mixed-effects model||||<0.001
71128991|NCT02160145|141763162|OTHER||Treatment difference|1.271|||<|0.0001|TWO_SIDED|95.0|0.859|1.684||A 2-sided alpha of 0.05 was applied to the primary analysis of the primary endpoint.|ANCOVA|Weighted Analysis of Covariance (ANCOVA) with effects of treatment and randomization stratification factors and covariate baseline.||Tolvaptan versus placebo. Treatment difference in the change of eGFR assessed the efficacy of tolvaptan treatment as compared with placebo in subjects with late-stage CKD due to ADPKD who tolerated tolvaptan during an initial run-in period.||1.684|0.859|<0.0001
71128992|NCT02160145|141763163|OTHER||Treatment difference|1.011|||<|0.0001|TWO_SIDED|95.0|0.618|1.403||A two-sided alpha of 0.05 was applied when the primary endpoint reached a two-sided alpha of 0.05.|Mixed Models Analysis|||Difference in treatment effect was derived from a linear mixed model with effects of treatment, time, treatment ime interaction, acute haemodynamic effect, pretreatment baseline, and randomization stratification factors. An unstructured variance matrix was assumed for the random intercept and time.||1.403|0.618|<0.0001
71128993|NCT04978818|141763169|NON_INFERIORITY|The anti-PRP IgG GMC for children receiving dose 1 of Vaxelis® was defined a priori as non-inferior if it was within a 1.5-fold margin of the GMC for children receiving dose 1 of PedvaxHIB®, corresponding to the lower bound of the 95% confidence interval (CI) of the IgG GMC ratio (Vaxelis® to PedvaxHIB®) being greater than 0.67.|Ratio of Geometric Mean Concentration|1.03||||0.85|TWO_SIDED|95.0|0.75|1.41|||Constrained Longitudinal Analysis||The lower bound of the 95% confidence interval was greater than the pre-specified non-inferiority margin of 0.67. Thus, Vaxelis® post-dose 1 anti-PRP IgG immunogenicity met the non-inferiority criterion compared to PedvaxHIB®.|||1.41|0.75|0.85
71128994|NCT04978818|141763170|OTHER|||||||0.39|||||||Chi-squared|||||||0.39
71128995|NCT04978818|141763171|OTHER|||||||0.64|||||||Chi-squared|||||||0.64
71128996|NCT04978818|141763172|OTHER|||||||0.87|||||||Chi-squared|||||||0.87
71128997|NCT04978818|141763173|OTHER|||||||0.3|||||||Chi-squared|||||||0.3
71128998|NCT04978818|141763174|OTHER|||||||0.15|||||||Chi-squared|||||||0.15
71128999|NCT04978818|141763175|OTHER|||||||0.03|||||||Chi-squared|||||||0.03
71129000|NCT01211340|141763176|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||The first analysis examined change from baseline to last available measure prior to death or the end of the study. The pre/post change was calculated for each participant and the Wilcoxon rank sum test was used to compare usual care and intervention groups with respect to changes. All randomized caregivers with at least 1 post baseline measure were included in the analysis.||||.18
71129001|NCT01211340|141763176|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|TWO_SIDED|95.0|||||Regression, Linear|No significant difference found between groups||The secondary analysis used a linear mixed model to test for groups differences over time. To account for repeated- measures nature of the data and the varying duration of participation, both participant specific intercept and slopes were treated as random effects. To minimize the leverage of relatively small number of participants with extremely long follow-up times we limited the number of days followed to 122, which was the 75th percentile of the days in the combined study.||||.18
71129002|NCT01211340|141763176|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|TWO_SIDED|95.0|||||Spearmans rank|No differences found||To test the effects of the dose of meetings on association with overall Caregiver Perceptions of Pain Medicine Questionaire (CPMQ) change we used Spearman rank correlation coefficient||||.18
71129003|NCT01211340|141763177|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|TWO_SIDED|95.0|||||Wilcxon Rank Sum Test|||The first analysis examined change from baseline to last available measure prior to death or the end of the study. The pre/post change was calculated for each participant and the Wilcoxon rank sum test was used to compare usual care and intervention groups with respect to changes. All randomized caregivers with at least 1 post baseline measure were included in the analysis.||||.15
71129004|NCT01211340|141763177|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|||||||Regression, Linear|||The secondary analysis used a linear mixed model to test for groups differences over time. To account for repeated- measures nature of the data and the varying duration of participation, both participant specific intercept and slopes were treated as random effects. To minimize the leverage of relatively small number of participants with extremely long follow-up times we limited the number of days followed to 122, which was the 75th percentile of the days in the combined study.||||.15
71129005|NCT01211340|141763178|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||The first analysis examined change from baseline to last available measure prior to death or the end of the study. The pre/post change was calculated for each participant and the Wilcoxon rank sum test was used to compare usual care and intervention groups with respect to changes. All randomized caregivers with at least 1 post baseline measure were included in the analysis.||||.89
71129006|NCT01211340|141763178|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89|||||||Regression, Linear|||The secondary analysis used a linear mixed model to test for groups differences over time. To account for repeated- measures nature of the data and the varying duration of participation, both participant specific intercept and slopes were treated as random effects. To minimize the leverage of relatively small number of participants with extremely long follow-up times we limited the number of days followed to 122, which was the 75th percentile of the days in the combined study.||||.89
71129007|NCT03755661|141763179|OTHER|pilot data to estimate effect size f-squared as the parameter as primary outcome||||||0.048||||||provide inferential statistics for data completion. Study is not designed to detect significant differences between groups|Regression, Linear|R-square change = .12; F-change (1, 20) = 4.44||pilot study to calculate effect size, study is not powered to detect significant group differences|"Computed f-squared as effect size estimate where baseline value of heavy drinking episodes entered in step 1 and condition in step 2~f- squared = .22"|||.048
71129008|NCT03755661|141763180|SUPERIORITY|"The main outcome variable is f-squared as an estimate of differences between conditions controlling for baseline value.~A statistical test is provided only for completeness as this study is not powered to detect significant effects"||||||0.34||||||F-change (1, 20) = 0.97|Regression, Linear|||pilot trial to compute effect size estimate|Computed f-squared as effect size estimate where baseline value of CAI entered in step 1 and condition in step 2 f- squared = .05, r-squared change = .04|||.34
71129009|NCT03755661|141763181|SUPERIORITY|This is a pilot trial to estimate effect sizes and not powered to detect significant differences||||||0.2||||||data provided for completeness, not powered to test differences|Regression, Linear|F-change (1, 20) = 1.80|||Computed f-squared as effect size estimate where baseline value of CAI entered in step 1 and condition in step 2 f- squared = .09, r-squared change = .058|||.20
71129010|NCT03755661|141763182|SUPERIORITY|Pilot trial not powered to detect significant group differences. Data from analyses presented for completeness. Primary outcome is effect size estimates||||||0.19|||||||Regression, Linear|F-change (1, 20) = 1.83||Pilot trial not powered to detect significant group differences|Computed f-squared as effect size estimate where baseline value of CAI entered in step 1 and condition in step 2 f- squared = .09, r-squared change = .048|||.19
71129011|NCT03755661|141763183|SUPERIORITY|||||||0.26||||||F-change (1, 19) = 1.34|Regression, Linear|||Not powered to test significant differences. provide data on effect size estimate below|Computed f-squared as effect size estimate where baseline value of CAI entered in step 1 and condition in step 2 f- squared = .05, r-squared change = .04|||.26
71129012|NCT05399290|141763188|OTHER|Chi square analysis was conducted to detect any significant between group differences (100 mg vs 20 mg) in perceived acne severity.||||||0.677|||||||Chi-squared|||||||0.677
71129013|NCT05399290|141763188|OTHER|Friedman's test was conducted for the 100 mg treatment arm to detect any significant within group differences in perceived acne severity.||||||0.002|||||||Friedman's test|||||||0.002
70858577|NCT01857310|141203233|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.2|0.2|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Semen volume will be compared using two sided tests conducted at the 0.05 level."||0.2|-0.2|
70858578|NCT01857310|141203233|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.1|0.2|||||Weighted for loss to follow-up and adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Semen volume will be compared using two sided tests conducted at the 0.05 level."||0.2|-0.1|
70858579|NCT01857310|141203234|SUPERIORITY||Mean Difference (Final Values)|-4.3|||||TWO_SIDED|95.1|-12.5|3.9|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. The confidence interval for sperm concentration represents 95.1% coverage to properly account for the alpha spent in the interim analysis."||3.9|-12.5|
70858580|NCT01857310|141203234|SUPERIORITY||Mean Difference (Final Values)|-5.2|||||TWO_SIDED|95.1|-13.6|3.1|||||Weighted for loss to follow-up and adjusted for fertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. The confidence interval for sperm concentration represents 95.1% coverage to properly account for the alpha spent in the interim analysis."||3.1|-13.6|
70858581|NCT01857310|141203235|SUPERIORITY||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.1|-2.5|1.5|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. The confidence interval for sperm motility represents 95.1% coverage to properly account for the alpha spent in the interim analysis."||1.5|-2.5|
70858582|NCT01857310|141203235|SUPERIORITY||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.1|-2.7|1.4|||||Weighted for loss to follow-up and adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. The confidence interval for sperm motility represents 95.1% coverage to properly account for the alpha spent in the interim analysis."||1.4|-2.7|
70858583|NCT01857310|141203236|SUPERIORITY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.1|-0.8|0.1|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. The confidence interval for sperm morphology represents 95.1% coverage to properly account for the alpha spent in the interim analysis."||0.1|-0.8|
70858584|NCT01857310|141203236|SUPERIORITY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.1|-0.9|0.0|||||Weighted for loss to follow-up and adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. The confidence interval for sperm morphology represents 95.1% coverage to properly account for the alpha spent in the interim analysis."||0|-0.9|
70858585|NCT01857310|141203237|SUPERIORITY||Mean Difference (Final Values)|2.4|||||TWO_SIDED|95.0|0.5|4.4|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. DNA fragmentation will be compared using two sided tests conducted at the 0.05 level."||4.4|0.5|
71129014|NCT05399290|141763188|OTHER|Friedman's test was conducted for the 20 mg treatment arm to detect any significant within group differences in perceived acne severity.||||||0.018|||||||Fried|||||||0.018
71129015|NCT03335774|141763201|SUPERIORITY|To determine if the 'hydrocortisone' arm was indeed superior than 'placebo' to reduce swelling and itching associated with internal hemorrhoids||||||0.8918|TWO_SIDED|95.0|||||t-test, 2 sided|||The statistical analyses were conducted using SAS software Version 9.4.All statistical tests were two-sided at a significance level of α = 0.05. Continuous data were presented using descriptive statistics (i.e. number of subjects, mean, SD, median, minimum, and maximum).Baseline value of each assessment was defined as the latest available assessment obtained prior to the first administration of the study drug.||||0.8918
71129016|NCT03335774|141763202|SUPERIORITY|To determine if the 'hydrocortisone' arm was indeed superior than 'placebo' to reduce swelling and itching associated with internal hemorrhoids||||||0.8323|TWO_SIDED|95.0|||||t-test, 2 sided|||The statistical analyses were conducted using SAS software Version 9.4.All statistical tests were two-sided at a significance level of α = 0.05. Continuous data were presented using descriptive statistics (i.e. number of subjects, mean, SD, median, minimum, and maximum).Baseline value of each assessment was defined as the latest available assessment obtained prior to the first administration of the study drug.||||0.8323
71129017|NCT04207749|141763212|NON_INFERIORITY|Noninferiority in CLCDVA was declared if the upper confidence limit was less than 0.10 logMAR.|Least Squares Mean Difference|0.01|||||TWO_SIDED|95.0|0.0|0.02||Since noninferiority hypotheses are being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|Mixed effects repeated measures||Least squares mean difference (LID015385 minus Biofinity).|||0.02|-0.00|
71129018|NCT04207749|141763213|NON_INFERIORITY|Proportion of subjects is presented. Noninferiority in proportion of subjects achieving CLCDVA 20/20 or better in each eye was declared if the lower confidence limit was greater than -0.10.|Difference in proportion|-0.01|||||TWO_SIDED|95.0|-0.06|0.04||Since noninferiority hypotheses are being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|Farrington-Manning||Lens difference (LID015385 minus Biofinity)|||0.04|-0.06|
70858586|NCT01857310|141203237|SUPERIORITY||Mean Difference (Final Values)|2.3|||||TWO_SIDED|95.0|0.3|4.3|||||Weighted for loss to follow-up and adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. DNA fragmentation will be compared using two sided tests conducted at the 0.05 level."||4.3|0.3|
70858587|NCT01857310|141203238|SUPERIORITY||Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-19.7|22.5|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Total motile sperm count will be compared using two sided tests conducted at the 0.05 level."||22.5|-19.7|
70858588|NCT01857310|141203238|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-20.9|21.4|||||Weighted for loss to follow-up and adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Total motile sperm count will be compared using two sided tests conducted at the 0.05 level."||21.4|-20.9|
70858589|NCT01857310|141203239|SUPERIORITY||Risk Difference (RD)|-0.9|||||TWO_SIDED|95.0|-4.7|3.0|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. hCG detected pregnancy will be compared using two sided tests conducted at the 0.05 level."||3.0|-4.7|
70858590|NCT01857310|141203239|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.91|1.09|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. hCG detected pregnancy will be compared using two sided tests conducted at the 0.05 level."||1.09|0.91|
70858591|NCT01857310|141203240|SUPERIORITY||Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-4.9|2.8|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Clinical intrauterine pregnancy will be compared using two sided tests conducted at the 0.05 level."||2.8|-4.9|
70858592|NCT01857310|141203240|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.89|1.08|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Clinical intrauterine pregnancy will be compared using two sided tests conducted at the 0.05 level."||1.08|0.89|
70858593|NCT01857310|141203241|SUPERIORITY||Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.5|0.6|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Ectopic pregnancy will be compared using two sided tests conducted at the 0.05 level."||0.6|-0.5|
70858594|NCT01857310|141203241|SUPERIORITY||Risk Ratio (RR)|1.21|||||TWO_SIDED|95.0|0.37|3.97|||||Adjusted for fertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Ectopic pregnancy will be compared using two sided tests conducted at the 0.05 level."||3.97|0.37|
70858595|NCT01857310|141203242|SUPERIORITY||Risk Difference (RD)|-1.1|||||TWO_SIDED|95.0|-3.7|1.5|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Early pregnancy loss will be compared using two sided tests conducted at the 0.05 level."||1.5|-3.7|
70858596|NCT01857310|141203242|SUPERIORITY||Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.75|1.15|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Early pregnancy loss will be compared using two sided tests conducted at the 0.05 level."||1.15|0.75|
70946786|NCT03672175|141393953|SUPERIORITY||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|2.28||0.2713|TWO_SIDED|95.0|-7.0|2.0||MMRM with treatment, BL HAM-D Bech-6 subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||2.0|-7.0|0.2713
70858597|NCT01857310|141203243|SUPERIORITY||Risk Difference (RD)|-0.3|||||TWO_SIDED|95.0|-1.9|1.3|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Preeclampsia/gestational hypertension will be compared using two sided tests conducted at the 0.05 level."||1.3|-1.9|
70858598|NCT01857310|141203243|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.63|1.36|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Preeclampsia/gestational hypertension will be compared using two sided tests conducted at the 0.05 level."||1.36|0.63|
70872048|NCT01652703|141229482|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-52.22|STANDARD_ERROR_OF_MEAN|3.06|<|0.001|TWO_SIDED|95.0|-58.27|-46.18||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-46.18|-58.27|<0.001
70946787|NCT03672175|141393953|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|2.43||0.8048|TWO_SIDED|95.0|-4.2|5.4||MMRM with treatment, BL HAM-D Bech-6 subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||5.4|-4.2|0.8048
70946788|NCT03672175|141393953|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.35||0.7665|TWO_SIDED|95.0|-5.3|3.9||MMRM with treatment, BL HAM-D Bech-6 subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||3.9|-5.3|0.7665
70946789|NCT03672175|141393954|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.91||0.8575|TWO_SIDED|95.0|-3.4|4.1||MMRM with treatment, BL HAM-D Maier subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||4.1|-3.4|0.8575
71129019|NCT05362058|141763214|NON_INFERIORITY|0.4% noninferiority margin (NIM)|LS Mean Difference|-0.09|||||TWO_SIDED|95.0|-0.22|0.04|||ANCOVA|||||0.04|-0.22|
71129020|NCT05362058|141763215|NON_INFERIORITY|0.4% noninferiority margin (NIM)|LS Mean Difference|-0.06|||||TWO_SIDED|95.0|-0.26|0.13|||ANCOVA|||||0.13|-0.26|
71129021|NCT05362058|141763216|NON_INFERIORITY|0.4% noninferiority margin (NIM)|LS Mean Difference|-0.11|||||TWO_SIDED|95.0|-0.28|0.07|||ANCOVA|||||0.07|-0.28|
71129022|NCT05362058|141763217|SUPERIORITY||LS Mean Difference|-0.09||||0.188|TWO_SIDED|95.0|-0.22|0.04|||ANCOVA|||||0.04|-0.22|0.188
71129023|NCT05362058|141763218|SUPERIORITY||LS Mean Difference|3.09||||0.043|TWO_SIDED|95.0|0.09|6.08|||ANCOVA|||||6.08|0.09|0.043
71129024|NCT05362058|141763219|SUPERIORITY||LS Mean Difference|-0.06||||0.26|TWO_SIDED|95.0|-0.17|0.05|||ANCOVA|||||0.05|-0.17|0.260
71129025|NCT05362058|141763220|SUPERIORITY||LS Mean Difference|0.27||||0.848|TWO_SIDED|95.0|-2.48|3.02|||ANCOVA|||||3.02|-2.48|0.848
71129026|NCT05362058|141763221|SUPERIORITY||LS Mean Difference|5.18||||0.014|TWO_SIDED|95.0|1.06|9.3|||ANCOVA|||Week 26 (Statistical Analysis) - LS mean was determined using ANCOVA model with Baseline + Country + HbA1c Stratum at Baseline + GLP-1 RA Use at Randomization + SU Use at Randomization + Treatment (Type III sum of squares) as variables. Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at week 26 were imputed by return-to-baseline multiple imputations approach.||9.30|1.06|0.014
71129027|NCT05362058|141763221|SUPERIORITY||LS Mean Difference|0.2||||0.918|TWO_SIDED|95.0|-3.65|4.06|||ANCOVA|||Week 52 (Statistical Analysis) - LS mean was determined using ANCOVA model with Baseline + Country + HbA1c Stratum at Baseline + GLP-1 RA Use at Randomization + SU Use at Randomization + Treatment (Type III sum of squares) as variables. Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at week 52 were imputed by return-to-baseline multiple imputations approach.||4.06|-3.65|0.918
71129028|NCT05362058|141763222|SUPERIORITY||LS Mean Difference|-0.36||||0.31|TWO_SIDED|95.0|-1.06|0.34|||Mixed Models Analysis|||Week 22 to Week 26 (Statistical Analysis)||0.34|-1.06|0.310
71129029|NCT05362058|141763222|SUPERIORITY||LS Mean Difference|-0.51||||0.138|TWO_SIDED|95.0|-1.19|0.17|||Mixed Models Analysis|||Week 48 to Week 52 (Statistical Analysis)||0.17|-1.19|0.138
71129030|NCT05362058|141763223|SUPERIORITY||LS Mean Difference|-13.2||||0.136|TWO_SIDED|95.0|-30.5|4.1|||Mixed Models Analysis|||Week 26 (Statistical Analysis)||4.1|-30.5|0.136
71129031|NCT05362058|141763223|SUPERIORITY||LS Mean Difference|-19.7||||0.026|TWO_SIDED|95.0|-37.0|-2.4|||Mixed Models Analysis|||Week 52 (Statistical Analysis)||-2.4|-37.0|0.026
71129032|NCT05362058|141763224|SUPERIORITY||Relative Rate|1.3||||0.111|TWO_SIDED|95.0|0.94|1.78|||Negative binomial model|||||1.78|0.94|0.111
71129033|NCT05362058|141763225|SUPERIORITY||Relative Rate|1.01||||0.983|TWO_SIDED|95.0|0.53|1.89|||Negative binomial model|||||1.89|0.53|0.983
71129034|NCT05362058|141763226|SUPERIORITY||LS Mean Difference|0.5||||0.025|TWO_SIDED|95.0|0.064|0.94|||Mixed Models Analysis|||Week 26 (Statistical Analysis)||0.94|0.064|0.025
71129035|NCT05362058|141763226|SUPERIORITY||LS Mean Difference|0.056||||0.801|TWO_SIDED|95.0|-0.38|0.5|||Mixed Models Analysis|||Week 52 (Statistical Analysis)||0.50|-0.38|0.801
71129036|NCT05362058|141763227|SUPERIORITY||LS Mean Difference|0.13||||0.374|TWO_SIDED|95.0|-0.15|0.41|||Mixed Models Analysis|||Week 8 to Week 12 (Statistical Analysis)||0.41|-0.15|0.374
71129037|NCT05362058|141763227|SUPERIORITY||LS Mean Difference|0.29||||0.13|TWO_SIDED|95.0|-0.09|0.67|||Mixed Models Analysis|||Week 22 to Week 26 (Statistical Analysis)||0.67|-0.09|0.130
71129038|NCT05362058|141763227|SUPERIORITY||LS Mean Difference|0.3||||0.162|TWO_SIDED|95.0|-0.12|0.72|||Mixed Models Analysis|||Week 48 to Week 52 (Statistical Analysis)||0.72|-0.12|0.162
71129039|NCT05362058|141763228|SUPERIORITY||LS Mean Difference|-0.03||||0.594|TWO_SIDED|95.0|-0.15|0.08|||Mixed Models Analysis|||Week 8 to Week 12 (Statistical Analysis)||0.08|-0.15|0.594
71129040|NCT05362058|141763228|SUPERIORITY||LS Mean Difference|0.06||||0.266|TWO_SIDED|95.0|-0.04|0.16|||Mixed Models Analysis|||Week 22 to Week 26 (Statistical Analysis)||0.16|-0.04|0.266
71129041|NCT05362058|141763228|SUPERIORITY||LS Mean Difference|0.02||||0.791|TWO_SIDED|95.0|-0.1|0.14|||Mixed Models Analysis|||Week 48 to Week 52 (Statistical Analysis)||0.14|-0.10|0.791
71129042|NCT05362058|141763229|SUPERIORITY||LS Mean Difference|-0.41||||0.757|TWO_SIDED|95.0|-3.0|2.18|||Mixed Models Analysis|||Week 8 to Week 12 (Statistical Analysis)||2.18|-3.00|0.757
71129043|NCT05362058|141763229|SUPERIORITY||LS Mean Difference|-0.93||||0.511|TWO_SIDED|95.0|-3.72|1.85|||Mixed Models Analysis|||Week 22 to Week 26 (Statistical Analysis)||1.85|-3.72|0.511
71129044|NCT05362058|141763229|SUPERIORITY||LS Mean Difference|-3.39||||0.027|TWO_SIDED|95.0|-6.39|-0.39|||Mixed Models Analysis|||Week 48 to Week 52 (Statistical Analysis)||-0.39|-6.39|0.027
71129045|NCT05362058|141763230|SUPERIORITY||LS Mean Difference|1.66||||0.021|TWO_SIDED|95.0|0.26|3.07|||Mixed Models Analysis|||Week 26 (Statistical Analysis)||3.07|0.26|0.021
71129046|NCT05362058|141763230|SUPERIORITY||LS Mean Difference|2.0||||0.006|TWO_SIDED|95.0|0.57|3.44|||Mixed Models Analysis|||Week 52 (Statistical Analysis)||3.44|0.57|0.006
71129047|NCT05362058|141763231|SUPERIORITY||LS Mean Difference|-0.2||||0.638|TWO_SIDED|95.0|-1.03|0.63|||Mixed Models Analysis|||Physical Component Score at Week 26 (Statistical Analysis) -LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.63|-1.03|0.638
71129048|NCT05362058|141763231|SUPERIORITY||LS Mean Difference|-0.32||||0.499|TWO_SIDED|95.0|-1.24|0.6|||Mixed Models Analysis|||Mental Component Score at Week 26 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.60|-1.24|0.499
71129049|NCT05362058|141763231|SUPERIORITY||LS Mean Difference|0.17||||0.695|TWO_SIDED|95.0|-0.68|1.01|||Mixed Models Analysis|||Physical Component Score at Week 52 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||1.01|-0.68|0.695
71129050|NCT05362058|141763231|SUPERIORITY||LS Mean Difference|-0.23||||0.626|TWO_SIDED|95.0|-1.17|0.71|||Mixed Models Analysis|||Mental Component Score at Week 52 (Statistical Analysis) -LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.71|-1.17|0.626
70946790|NCT03672175|141393954|SUPERIORITY||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|1.94||0.1978|TWO_SIDED|95.0|-6.3|1.3||MMRM with treatment, BL HAM-D Maier subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||1.3|-6.3|0.1978
71129051|NCT05362058|141763232|SUPERIORITY||LS Mean Difference|-0.015||||0.128|TWO_SIDED|95.0|-0.034|0.004|||Mixed Models Analysis|||EQ-5D-5L Health State Index Score at Week 26 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.004|-0.034|0.128
71129052|NCT05362058|141763232|SUPERIORITY||LS Mean Difference|-1.11||||0.196|TWO_SIDED|95.0|-2.8|0.58|||Mixed Models Analysis|||EQ VAS Score at Week 26 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.58|-2.80|0.196
71129053|NCT05362058|141763232|SUPERIORITY||LS Mean Difference|-0.01||||0.285|TWO_SIDED|95.0|-0.029|0.008|||Mixed Models Analysis|||EQ-5D-5L Health State Index Score at Week 52 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.008|-0.029|0.285
71129054|NCT05362058|141763232|SUPERIORITY||LS Mean Difference|-0.35||||0.701|TWO_SIDED|95.0|-2.15|1.44|||Mixed Models Analysis|||EQ VAS Score at Week 52 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||1.44|-2.15|0.701
71129055|NCT00930553|141763249|SUPERIORITY_OR_OTHER||Percentage with SAD|22.33|||||TWO_SIDED|95.0|18.33|27.06|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.|||27.06|18.33|
71129056|NCT00930553|141763249|SUPERIORITY_OR_OTHER||Percentage with SAD|29.69|||||TWO_SIDED|95.0|25.42|34.49|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.|||34.49|25.42|
71129057|NCT00930553|141763250|SUPERIORITY_OR_OTHER||Percentage with SAD|9.35|||||TWO_SIDED|95.0|5.54|15.56|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.|||15.56|5.54|
71129058|NCT00930553|141763250|SUPERIORITY_OR_OTHER||Percentage with SAD|7.95|||||TWO_SIDED|95.0|4.48|13.9|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.|||13.90|4.48|
71129059|NCT00930553|141763250|SUPERIORITY_OR_OTHER||Percentage with SAD|20.42|||||TWO_SIDED|95.0|14.67|28.03|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.|||28.03|14.67|
71129060|NCT00930553|141763250|SUPERIORITY_OR_OTHER||Percentage with SAD|11.99|||||TWO_SIDED|95.0|7.63|18.58|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.|||18.58|7.63|
71129061|NCT00930553|141763251|SUPERIORITY_OR_OTHER||Percentage with SRD|32.69|||||TWO_SIDED|95.0|26.96|39.28|||||The percentage and 95% CI of the participants with SRD are estimated by the Kaplan Meier method.|||39.28|26.96|
71129062|NCT00930553|141763251|SUPERIORITY_OR_OTHER||Percentage with SRD|42.46|||||TWO_SIDED|95.0|37.08|48.28|||||The percentage and 95% CI of the participants with SRD are estimated by the Kaplan Meier method.|||48.28|37.08|
71129063|NCT00930553|141763252|SUPERIORITY_OR_OTHER||Percentage with SRD|16.92|||||TWO_SIDED|95.0|9.75|28.47|||||The percentage and 95% CI of the participants with SRD are estimated by the Kaplan Meier method.|||28.47|9.75|
71129064|NCT00930553|141763252|SUPERIORITY_OR_OTHER||Percentage with SRD|13.89|||||TWO_SIDED|95.0|8.47|22.33|||||The percentage and 95% CI of the participants with SRD are estimated by the Kaplan Meier method.|||22.33|8.47|
71129065|NCT04042909|141763276|SUPERIORITY||beta coefficient|-0.309|STANDARD_ERROR_OF_MEAN|0.69||0.646|TWO_SIDED|95.0|-1.632|1.013||This is the p-value of the CAA vs AO factor in the model.|Regression, Linear|We used linear regression, controlling for baseline value of outcome and sex, to determine change in the outcome as a function of condition.||Our main hypothesis is that, relative to Assessment-Only control, the Counter Attitudinal Advocacy intervention will decrease alcohol consumption (drinks per week) from baseline to 6-months.||1.013|-1.632|.646
71129066|NCT04042909|141763277|SUPERIORITY||beta coefficient|-1.9|STANDARD_ERROR_OF_MEAN|0.77||0.014|TWO_SIDED|95.0|-3.41|-0.39|||Regression, Linear|We used regression, controlling for baseline value of outcome and sex, to determine pre-post change in the outcome as a function of condition.||Our main hypothesis is that, relative to Assessment-Only control, the Counter Attitudinal Advocacy intervention will decrease alcohol problems from baseline to 6-months.||-0.39|-3.41|.014
71129067|NCT00286494|141763309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||<|0.001|TWO_SIDED|95.0|-0.67|-0.28||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Treatment, treatment regimen and geographic region as class variables; baseline pioglitazone dose and baseline value for the endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at wk 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=500 subjects had 95% power to detect a treatment difference as small as 0.4% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level and \>=80% of subjects meeting per protocol criteria.||-0.28|-0.67|<0.001
70946791|NCT03672175|141393954|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|2.08||0.9298|TWO_SIDED|95.0|-3.9|4.3||MMRM with treatment, BL HAM-D Maier subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||4.3|-3.9|0.9298
71129068|NCT00286494|141763309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|||<|0.001|TWO_SIDED|95.0|-0.8|-0.41||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Treatment, treatment regimen and geographic region as class variables; baseline pioglitazone dose and baseline value for the endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at wk 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=500 subjects had 95% power to detect a treatment difference as small as 0.4% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level and \>=80% of subjects meeting per protocol criteria.||-0.41|-0.80|<0.001
71129069|NCT00286494|141763310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|||<|0.001|TWO_SIDED|95.0|-0.36|-0.16||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.16|-0.36|<0.001
71129070|NCT00286494|141763310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|||<|0.001|TWO_SIDED|95.0|-0.41|-0.21||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.21|-0.41|<0.001
71129071|NCT00286494|141763311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.56|-0.27||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.27|-0.56|<0.001
71129072|NCT00286494|141763311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|||<|0.001|TWO_SIDED|95.0|-0.69|-0.4||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.40|-0.69|<0.001
71129073|NCT00286494|141763312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|||<|0.001|TWO_SIDED|95.0|-0.63|-0.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.30|-0.63|<0.001
71129074|NCT00286494|141763312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||<|0.001|TWO_SIDED|95.0|-0.75|-0.43||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.43|-0.75|<0.001
71129075|NCT00286494|141763313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|||<|0.001|TWO_SIDED|95.0|-0.63|-0.26||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.26|-0.63|<0.001
71129076|NCT00286494|141763313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|||<|0.001|TWO_SIDED|95.0|-0.76|-0.4||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.40|-0.76|<0.001
71129077|NCT00286494|141763314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|||<|0.001|TWO_SIDED|95.0|-0.6|-0.22||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.22|-0.60|<0.001
71129078|NCT00286494|141763314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|||<|0.001|TWO_SIDED|95.0|-0.74|-0.36||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.36|-0.74|<0.001
71129079|NCT00286494|141763315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.4||||0.003|TWO_SIDED|95.0|-18.9|-3.9||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-3.9|-18.9|0.003
71129080|NCT00286494|141763315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.5|||<|0.001|TWO_SIDED|95.0|-23.0|-8.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.0|-23.0|<0.001
70946792|NCT03672175|141393954|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|2.03||0.5487|TWO_SIDED|95.0|-5.2|2.8||MMRM with treatment, BL HAM-D Maier subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||2.8|-5.2|0.5487
70946793|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.627|TWO_SIDED|95.0|-0.2|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Depressed Mood||0.3|-0.2|0.6270
70946794|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.5463|TWO_SIDED|95.0|-0.4|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Depressed Mood||0.2|-0.4|0.5463
70946795|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.15||0.8716|TWO_SIDED|95.0|-0.3|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Depressed Mood||0.3|-0.3|0.8716
71129081|NCT00286494|141763316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.2|||<|0.001|TWO_SIDED|95.0|-26.4|-11.9||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-11.9|-26.4|<0.001
71129082|NCT00286494|141763316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.4|||<|0.001|TWO_SIDED|95.0|-26.6|-12.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-12.3|-26.6|<0.001
71129083|NCT00286494|141763317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.6|||<|0.001|TWO_SIDED|95.0|-27.5|-13.6||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-13.6|-27.5|<0.001
71129084|NCT00286494|141763317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.0|||<|0.001|TWO_SIDED|95.0|-29.9|-16.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-16.0|-29.9|<0.001
71129085|NCT00286494|141763318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.5|||<|0.001|TWO_SIDED|95.0|-24.4|-8.7||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.7|-24.4|<0.001
70858599|NCT01857310|141203244|SUPERIORITY||Risk Difference (RD)|-0.7|||||TWO_SIDED|95.0|-1.9|0.6|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Gestational diabetes will be compared using two sided tests conducted at the 0.05 level."||0.6|-1.9|
70858600|NCT01857310|141203244|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.47|1.27|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Gestational diabetes will be compared using two sided tests conducted at the 0.05 level."||1.27|0.47|
70858601|NCT01857310|141203245|SUPERIORITY||Risk Difference (RD)|1.2|||||TWO_SIDED|95.0|-1.4|3.8|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Cesarean delivery will be compared using two sided tests conducted at the 0.05 level."||3.8|-1.4|
70858602|NCT01857310|141203245|SUPERIORITY||Risk Ratio (RR)|1.12|||||TWO_SIDED|95.0|0.89|1.39|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Cesarean delivery will be compared using two sided tests conducted at the 0.05 level."||1.39|0.89|
70858603|NCT01857310|141203246|SUPERIORITY||Risk Difference (RD)|1.9|||||TWO_SIDED|95.0|0.2|3.6|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Preterm delivery will be compared using two sided tests conducted at the 0.05 level."||3.6|0.2|
70858604|NCT01857310|141203246|SUPERIORITY||Risk Ratio (RR)|1.49|||||TWO_SIDED|95.0|1.04|2.16|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Preterm delivery will be compared using two sided tests conducted at the 0.05 level."||2.16|1.04|
70858605|NCT01857310|141203247|SUPERIORITY||Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-1.5|2.0|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Small for gestational age will be compared using two sided tests conducted at the 0.05 level."||2.0|-1.5|
70858606|NCT01857310|141203247|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.75|1.49|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Small for gestational age will be compared using two sided tests conducted at the 0.05 level."||1.49|0.75|
71129086|NCT00286494|141763318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.1|||<|0.001|TWO_SIDED|95.0|-28.9|-13.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-13.3|-28.9|<0.001
71129087|NCT00286494|141763319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4||||0.011|TWO_SIDED|95.0|-18.5|-2.4||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-2.4|-18.5|0.011
70946796|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.4383|TWO_SIDED|95.0|-0.4|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Depressed Mood||0.2|-0.4|0.4383
70946797|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4794|TWO_SIDED|95.0|-0.1|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Feelings of Guilt||0.3|-0.1|0.4794
70946798|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.9717|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Feelings of Guilt||0.2|-0.2|0.9717
71129088|NCT00286494|141763319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.3|||<|0.001|TWO_SIDED|95.0|-24.3|-8.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.3|-24.3|<0.001
70858607|NCT01857310|141203248|SUPERIORITY||Risk Difference (RD)|-0.2|||||TWO_SIDED|95.0|-0.5|0.1|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Gestational age will be compared using two sided tests conducted at the 0.05 level."||0.1|-0.5|
70858608|NCT01857310|141203249|SUPERIORITY||Risk Difference (RD)|-64.7|||||TWO_SIDED|95.0|-156.0|26.4|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Birth weight will be compared using two sided tests conducted at the 0.05 level."||26.4|-156|
70858609|NCT01857310|141203250|SUPERIORITY||Risk Difference (RD)|-0.2|||||TWO_SIDED|95.0|-0.6|0.1|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Stillbirth will be compared using two sided tests conducted at the 0.05 level."||0.1|-0.6|
70858610|NCT01857310|141203250|SUPERIORITY||Risk Ratio (RR)|0.25|||||TWO_SIDED|95.0|0.03|2.24|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Stillbirth will be compared using two sided tests conducted at the 0.05 level."||2.24|0.03|
70858611|NCT01857310|141203251|SUPERIORITY||Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.3|0.5|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Neonatal mortality will be compared using two sided tests conducted at the 0.05 level."||0.5|-0.3|
70858612|NCT01857310|141203251|SUPERIORITY||Risk Ratio (RR)|1.5|||||TWO_SIDED|95.0|0.25|8.95|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Neonatal mortality will be compared using two sided tests conducted at the 0.05 level."||8.95|0.25|
71129089|NCT00286494|141763320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.0||||0.029|TWO_SIDED|95.0|-18.9|-1.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-1.0|-18.9|0.029
70946799|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.11||0.3701|TWO_SIDED|95.0|-0.1|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Feelings of Guilt||0.3|-0.1|0.3701
70858613|NCT01857310|141203252|SUPERIORITY||Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.2|0.4|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Major neonatal complications will be compared using two sided tests conducted at the 0.05 level."||0.4|-0.2|
70858614|NCT01857310|141203252|SUPERIORITY||Risk Ratio (RR)|1.99|||||TWO_SIDED|95.0|0.18|21.9|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Major neonatal complications will be compared using two sided tests conducted at the 0.05 level."||21.9|0.18|
70946800|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.11||0.3972|TWO_SIDED|95.0|-0.1|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Feelings of Guilt||0.3|-0.1|0.3972
71129090|NCT00286494|141763320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.4||||0.002|TWO_SIDED|95.0|-23.3|-5.5||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-5.5|-23.3|0.002
71129091|NCT00286494|141763321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.6|||<|0.001|TWO_SIDED|95.0|-24.2|-6.9||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-6.9|-24.2|<0.001
71129092|NCT00286494|141763321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.2|||<|0.001|TWO_SIDED|95.0|-23.8|-6.7||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-6.7|-23.8|<0.001
71129093|NCT00286494|141763322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.9||||0.003|TWO_SIDED|95.0|-23.1|-4.8||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-4.8|-23.1|0.003
71129094|NCT00286494|141763322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.1||||0.003|TWO_SIDED|95.0|-23.3|-5.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-5.0|-23.3|0.003
71129095|NCT00286494|141763323|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.271|||<|0.001|TWO_SIDED|95.0|0.147|0.499||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen, \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.499|0.147|<0.001
71129096|NCT00286494|141763323|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.235|||<|0.001|TWO_SIDED|95.0|0.126|0.438||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen, \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.438|0.126|<0.001
71129097|NCT00286494|141763324|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.628||||0.266|TWO_SIDED|95.0|0.277|1.425||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||1.425|0.277|0.266
70858615|NCT01857310|141203253|SUPERIORITY||Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.8|1.0|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Structural malformations will be compared using two sided tests conducted at the 0.05 level."||1.0|-0.8|
70858616|NCT01857310|141203253|SUPERIORITY||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.53|2.21|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Structural malformations will be compared using two sided tests conducted at the 0.05 level."||2.21|0.53|
70858617|NCT01857310|141203254|SUPERIORITY||Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Severe maternal morbidity will be compared using two sided tests conducted at the 0.05 level."||1.3|-0.4|
70946801|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.5761|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Suicide||0.1|-0.1|0.5761
71129098|NCT00286494|141763324|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.658||||0.315|TWO_SIDED|95.0|0.292|1.487|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||1.487|0.292|0.315
71129099|NCT00286494|141763325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.4||||0.003|TWO_SIDED|95.0|-10.6|-2.1||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-2.1|-10.6|0.003
71129100|NCT00286494|141763325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9||||0.023|TWO_SIDED|95.0|-9.1|-0.7||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.7|-9.1|0.023
71129101|NCT00286494|141763326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2||||0.043|TWO_SIDED|95.0|-8.3|-0.1||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.1|-8.3|0.043
71129102|NCT00286494|141763326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.489|TWO_SIDED|95.0|-5.5|2.6||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.6|-5.5|0.489
71129103|NCT00286494|141763327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2||||0.068|TWO_SIDED|95.0|-8.8|0.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.3|-8.8|0.068
70946802|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.4379|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Suicide||0.1|-0.1|0.4379
71129104|NCT00286494|141763327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.056|TWO_SIDED|95.0|-8.9|0.1||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.1|-8.9|0.056
70858618|NCT01857310|141203254|SUPERIORITY||Risk Ratio (RR)|1.5|||||TWO_SIDED|95.0|0.68|3.32|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Severe maternal morbidity will be compared using two sided tests conducted at the 0.05 level."||3.32|0.68|
70946803|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.6087|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Suicide||0.1|-0.1|0.6087
71129105|NCT00286494|141763328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.884|TWO_SIDED|95.0|-4.9|4.2||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.2|-4.9|0.884
71129106|NCT00286494|141763328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.993|TWO_SIDED|95.0|-4.5|4.5||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.5|-4.5|0.993
71129107|NCT00286494|141763329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3||||0.009|TWO_SIDED|95.0|-9.4|-1.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-1.3|-9.4|0.009
71129108|NCT00286494|141763329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.143|TWO_SIDED|95.0|-7.0|1.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.0|-7.0|0.143
71129109|NCT00286494|141763330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1||||0.08|TWO_SIDED|95.0|-8.6|0.5||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.5|-8.6|0.080
71129110|NCT00286494|141763330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.782|TWO_SIDED|95.0|-5.2|3.9||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.9|-5.2|0.782
71129111|NCT00286494|141763331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||0.249|TWO_SIDED|95.0|-2.68|0.7||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.70|-2.68|0.249
71129112|NCT00286494|141763331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88||||0.303|TWO_SIDED|95.0|-2.56|0.8||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.80|-2.56|0.303
71129113|NCT00286494|141763332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.478|TWO_SIDED|95.0|-2.46|1.15||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.15|-2.46|0.478
71129114|NCT00286494|141763332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38||||0.674|TWO_SIDED|95.0|-1.41|2.17||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.17|-1.41|0.674
71129115|NCT00286494|141763333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.743|TWO_SIDED|95.0|-2.18|3.06||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.06|-2.18|0.743
70858619|NCT01857310|141203255|SUPERIORITY||Mean Difference (Final Values)|-2.34|||||TWO_SIDED|95.0|-7.9|3.23||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Fertilization rate will be compared using generalized estimating equations accounting for multiple cycles per couple."||3.23|-7.90|
70858620|NCT01857310|141203256|SUPERIORITY||Mean Difference (Final Values)|-0.11|||||TWO_SIDED|95.0|-0.33|0.11||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Number of good quality embryos will be compared using Poisson regression with generalized estimating equations accounting for multiple cycles per couple."||0.11|-0.33|
70858621|NCT01857310|141203257|SUPERIORITY||Mean Difference (Final Values)|-1.31|||||TWO_SIDED|95.0|-6.66|4.05||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Proportion of good quality embryos on day 5 will be compared using generalized estimating equations accounting for multiple cycles per couple."||4.05|-6.66|
70858622|NCT01857310|141203258|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.11|0.1||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Number of embryos transferred will be compared using Poisson regression with generalized estimating equations accounting for multiple cycles per couple."||0.10|-0.11|
70858623|NCT01857310|141203259|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.23|0.18||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Number of embryos cryopreserved will be compared using Poisson regression with generalized estimating equations accounting for multiple cycles per couple."||0.18|-0.23|
70858624|NCT01857310|141203260|SUPERIORITY||Mean Difference (Final Values)|-12.1|||||TWO_SIDED|95.0|-45.4|21.2||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Sperm penetration percentage will be compared using generalized estimating equations accounting for multiple cycles per couple."||21.2|-45.4|
70858625|NCT01857310|141203261|SUPERIORITY||Mean Difference (Final Values)|-0.07|||||TWO_SIDED|95.0|-0.16|0.03||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Number of cells on day 3 will be compared with Poisson regression using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||0.03|-0.16|
70858626|NCT01857310|141203262|SUPERIORITY||Risk Ratio (RR)|1.19|||||TWO_SIDED|95.0|0.88|1.61|||||Fewer than 4 cells|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Number of cells on day 3 will be compared using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||1.61|0.88|
70858627|NCT01857310|141203263|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.77|1.43|||||Fewer than 8 cells|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Number of cells on day 5 will be compared using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||1.43|0.77|
70858628|NCT01857310|141203264|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.87|1.09|||||Excellent or good morphology|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Embryo morphology on day 3 will be compared using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||1.09|0.87|
70858629|NCT01857310|141203265|SUPERIORITY||Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.63|1.06|||||Excellent or good morphology|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Embryo morphology on day 5 will be compared using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||1.06|0.63|
70858630|NCT01857310|141203266|SUPERIORITY||Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.8|1.09|||||ICSI|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Method of fertilization will be compared using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||1.09|0.80|
70858631|NCT01857310|141203267|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.88|1.21|||||Excellent or good quality|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Quality of embryos transferred will be compared using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||1.21|0.88|
70858632|NCT01857310|141203268|SUPERIORITY||Risk Ratio (RR)|2.35|||||TWO_SIDED|95.0|0.74|7.43|||||Abnormal|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Chromosomal complement will be compared using generalized estimating equations accounting for multiple cycles per couple."||7.43|0.74|
70858633|NCT02635646|141203323|OTHER|T test for mean comparisons between independent groups||||||0.844||||||Significant p value less than 0.05|t-test, 2 sided|||||||0.844
70946804|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.9791|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Suicide||0.1|-0.1|0.9791
71129116|NCT00286494|141763333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.662|TWO_SIDED|95.0|-3.18|2.02||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.02|-3.18|0.662
71129117|NCT00286494|141763334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75||||0.39|TWO_SIDED|95.0|-0.96|2.45||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.45|-0.96|0.390
71129118|NCT00286494|141763334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69||||0.423|TWO_SIDED|95.0|-1.0|2.38||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.38|-1.00|0.423
71129119|NCT00286494|141763335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.807|TWO_SIDED|95.0|-1.87|1.46||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.46|-1.87|0.807
71129120|NCT00286494|141763335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.867|TWO_SIDED|95.0|-1.79|1.51||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.51|-1.79|0.867
71129121|NCT00286494|141763336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61||||0.483|TWO_SIDED|95.0|-1.1|2.33||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.33|-1.10|0.483
71129122|NCT00286494|141763336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81||||0.352|TWO_SIDED|95.0|-0.89|2.51||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.51|-0.89|0.352
71129123|NCT00286494|141763337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.057||||0.001|TWO_SIDED|95.0|-0.092|-0.022||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.022|-0.092|0.001
71129124|NCT00286494|141763337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.059||||0.001|TWO_SIDED|95.0|-0.093|-0.024||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.024|-0.093|0.001
71129125|NCT00286494|141763338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.049||||0.006|TWO_SIDED|95.0|-0.084|-0.014||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.014|-0.084|0.006
71129126|NCT00286494|141763338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.051||||0.004|TWO_SIDED|95.0|-0.086|-0.016||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.016|-0.086|0.004
71129127|NCT00286494|141763339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.046||||0.05|TWO_SIDED|95.0|-0.092|0.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.000|-0.092|0.050
71129128|NCT00286494|141763339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.057||||0.014|TWO_SIDED|95.0|-0.102|-0.012||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.012|-0.102|0.014
70858634|NCT02635646|141203324|OTHER|||||||0.624|||||||t-test, 2 sided|||||||0.624
70858635|NCT02635646|141203325|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71129129|NCT00286494|141763340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.027||||0.144|TWO_SIDED|95.0|-0.064|0.009||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.009|-0.064|0.144
71129130|NCT00286494|141763340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.105|TWO_SIDED|95.0|-0.067|0.006||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.006|-0.067|0.105
71129131|NCT00286494|141763341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.059||||0.004|TWO_SIDED|95.0|-0.1|-0.019||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.019|-0.100|0.004
71129132|NCT00286494|141763341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.051||||0.012|TWO_SIDED|95.0|-0.092|-0.011||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.011|-0.092|0.012
71129133|NCT00286494|141763342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.028|TWO_SIDED|95.0|-0.095|-0.005||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.005|-0.095|0.028
71129134|NCT00286494|141763342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.038||||0.093|TWO_SIDED|95.0|-0.082|0.006||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.006|-0.082|0.093
71129135|NCT00286494|141763343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012||||0.928|TWO_SIDED|95.0|-0.28|0.255||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.255|-0.280|0.928
71129136|NCT00286494|141763343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056||||0.683|TWO_SIDED|95.0|-0.212|0.324||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.324|-0.212|0.683
70858636|NCT02635646|141203326|OTHER|||||||0.516|||||||t-test, 2 sided|||||||0.516
70858637|NCT02635646|141203327|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71129137|NCT00286494|141763344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006||||0.967|TWO_SIDED|95.0|-0.277|0.265||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.265|-0.277|0.967
70858638|NCT00251004|141203339|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%.|Difference in percentage|2.2||||0.001|TWO_SIDED|95.0|-2.9|7.3||To control for multiple comparisons, the two-sided significance level was set at 0.025.|Z-test|||Everolimus is non-inferior to mycophenolic acid (MPA) if the upper limit of the 95% confidence interval for the difference in combined graft loss, death or loss to follow-up rates is \<10%.||7.3|-2.9|0.001
71129138|NCT00286494|141763344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135||||0.327|TWO_SIDED|95.0|-0.135|0.405||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.405|-0.135|0.327
71129139|NCT00286494|141763345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.068||||0.649|TWO_SIDED|95.0|-0.363|0.226||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.226|-0.363|0.649
71129140|NCT00286494|141763345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.051||||0.735|TWO_SIDED|95.0|-0.344|0.243||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.243|-0.344|0.735
71129141|NCT00286494|141763346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.114|TWO_SIDED|95.0|-0.053|0.492||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.492|-0.053|0.114
71129142|NCT00286494|141763346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238||||0.086|TWO_SIDED|95.0|-0.033|0.51||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.510|-0.033|0.086
70858639|NCT00251004|141203339|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%.|Difference in Percentage|0.3|||<|0.001|TWO_SIDED|95.0|-4.6|5.2||To control for multiple comparisons, the two-sided significance level was set at 0.025.|Z-test|||Everolimus is non-inferior to MPA if the upper limit of the 95% confidence interval for the difference in combined graft loss, death or loss to follow-up rates is \<10%.||5.2|-4.6|<0.001
70858640|NCT00251004|141203340|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%.|Difference in percentage|1.8||||0.014|TWO_SIDED|95.0|-5.5|9.1||To control for multiple comparisons, the two-sided significance level was set at 0.025.|Z - test|||Everolimus is non-inferior to mycophenolic acid (MPA) if the upper limit of the 95% confidence interval for the difference in percentage of participants composite efficacy failure is \<10%.||9.1|-5.5|0.014
70858641|NCT00251004|141203340|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%.|Difference in percentage|-3.8|||<|0.001|TWO_SIDED|95.0|-10.8|3.3||To control for multiple comparisons, the two-sided significance level was set at 0.025.|Z-test|||Everolimus is non-inferior to MPA if the upper limit of the 95% confidence interval for the difference in composite efficacy failure rates is \<10%.||3.3|-10.8|<0.001
70858642|NCT00251004|141203341|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at -8 mL/min/1.73m\^2.|Mean Difference (Net)|2.42|||<|0.001|TWO_SIDED|95.0|-1.6|6.5||To control for multiple comparisons, the two-sided significance level was set at 0.025.|t-test, 2 sided|||The null hypothesis: the mean GFR of the everolimus arm is lower (worse) than that of the MPA arm by 8 mL/min/1.73m\^2 or more.||6.5|-1.6|<0.001
70858643|NCT00251004|141203341|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at -8 mL/min/1.73m\^2.|Mean Difference (Net)|-0.83|||<|0.001|TWO_SIDED|95.0|-4.9|3.3||To control for multiple comparisons, the two-sided significance level was set at 0.025.|t-test, 2 sided|||The null hypothesis: the mean GFR of the everolimus arm is lower (worse) than that of the MPA arm by 8 mL/min/1.73m\^2 or more.||3.3|-4.9|<0.001
70858644|NCT00645788|141203342|SUPERIORITY_OR_OTHER|||||||0.076|||||||ANCOVA|||"Ho: \|Cipro 32.5 mg - matching placebo\|=0 and \|Cipro 48.75 mg - matching placebo\|=0"||||0.076
70858645|NCT00645788|141203344|SUPERIORITY_OR_OTHER|||||||0.068|||||||ANCOVA|||"At visit 7 (End of treatment) Ho: \|Cipro 32.5 - matching placebo\| =0 and~\|Cipro 48.75 - matching placebo\| =0"||||0.068
70858646|NCT03149848|141203354|OTHER||Ratio|0.786|||||TWO_SIDED|90.0|0.743|0.831||||||||0.831|0.743|
70858647|NCT03149848|141203355|OTHER||Ratio|0.825|||||TWO_SIDED|90.0|0.761|0.895||||||||0.895|0.761|
70858648|NCT03149848|141203356|OTHER||Ratio|0.738|||||TWO_SIDED|90.0|0.702|0.776||||||||0.776|0.702|
70858649|NCT03149848|141203359|OTHER||Ratio|1.272|||||TWO_SIDED|90.0|1.204|1.345||||||||1.345|1.204|
71129143|NCT00286494|141763347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026||||0.835|TWO_SIDED|95.0|-0.221|0.273||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.273|-0.221|0.835
70858650|NCT01244490|141203377|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-8.9|||<|0.001|TWO_SIDED|95.0|-11.9|-5.8|||ANCOVA|||||-5.8|-11.9|<0.001
70858651|NCT01244490|141203377|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-3.8||||0.017|TWO_SIDED|95.0|-6.8|-0.7|||ANCOVA|||||-0.7|-6.8|0.017
70858652|NCT01244490|141203378|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage Improvement|23.7|||<|0.001|TWO_SIDED|95.0|11.1|36.4|||Cochran-Mantel-Haenszel|||||36.4|11.1|<0.001
70858653|NCT01244490|141203378|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage Improvement|12.1||||0.024|TWO_SIDED|95.0|-0.9|25.1|||Cochran-Mantel-Haenszel|||||25.1|-0.9|0.024
70858654|NCT01244490|141203379|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.217||||0.003|TWO_SIDED|95.0|-0.358|-0.076|||ANCOVA|||||-0.076|-0.358|0.003
70858655|NCT01244490|141203379|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.162||||0.026|TWO_SIDED|95.0|-0.305|-0.019|||ANCOVA|||||-0.019|-0.305|0.026
70858656|NCT01244490|141203380|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.209||||0.006|TWO_SIDED|95.0|-0.358|-0.059|||ANCOVA|||||-0.059|-0.358|0.006
70858657|NCT01244490|141203380|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.09||||0.242|TWO_SIDED|95.0|-0.241|0.061|||ANCOVA|||||0.061|-0.241|0.242
70858658|NCT01244490|141203381|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Nominal p-value uncorrected for multiplicity.|Cochran-Mantel-Haenszel|||||||<0.001
70858659|NCT01244490|141203381|SUPERIORITY_OR_OTHER_LEGACY|||||||0.196||||||Nominal p-value uncorrected for multiplicity.|Cochran-Mantel-Haenszel|||||||0.196
71129144|NCT00286494|141763347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131||||0.296|TWO_SIDED|95.0|-0.115|0.378||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.378|-0.115|0.296
70858660|NCT01244490|141203383|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.165||||0.001|TWO_SIDED|95.0|-0.266|-0.064||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-0.064|-0.266|0.001
70858661|NCT01244490|141203383|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.104||||0.048|TWO_SIDED|95.0|-0.207|-0.001||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-0.001|-0.207|0.048
70858662|NCT01244490|141203384|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.211||||0.043|TWO_SIDED|95.0|-0.416|-0.007||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-0.007|-0.416|0.043
70858663|NCT01244490|141203384|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.125||||0.231|TWO_SIDED|95.0|-0.331|0.08||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.080|-0.331|0.231
70858664|NCT01244490|141203385|SUPERIORITY_OR_OTHER_LEGACY||Diiference in Least Squares Mean|-0.229|||<|0.001|TWO_SIDED|95.0|-0.364|-0.094||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-0.094|-0.364|<0.001
70858665|NCT01244490|141203385|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.181||||0.009|TWO_SIDED|95.0|-0.317|-0.045||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-0.045|-0.317|0.009
70858666|NCT01244490|141203386|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.094||||0.096|TWO_SIDED|95.0|-0.204|0.017||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.017|-0.204|0.096
70858667|NCT01244490|141203386|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.067||||0.242|TWO_SIDED|95.0|-0.18|0.046||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.046|-0.180|0.242
70858668|NCT01244490|141203387|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.049||||0.5|TWO_SIDED|95.0|-0.191|0.094||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.094|-0.191|0.500
70858669|NCT01244490|141203387|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.078||||0.288|TWO_SIDED|95.0|-0.222|0.066||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.066|-0.222|0.288
70858670|NCT01244490|141203388|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.233||||0.001|TWO_SIDED|95.0|-0.374|-0.092||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-0.092|-0.374|0.001
70858671|NCT01244490|141203388|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.111||||0.124|TWO_SIDED|95.0|-0.253|0.031||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.031|-0.253|0.124
70858672|NCT01244490|141203389|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.056||||0.139|TWO_SIDED|95.0|-0.131|0.018||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.018|-0.131|0.139
70858673|NCT01244490|141203389|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.039||||0.315|TWO_SIDED|95.0|-0.115|0.037||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.037|-0.115|0.315
70858674|NCT00971620|141203396|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.7|TWO_SIDED|95.0|-2.0|4.0|||Wilcoxon rank sum test|||||4.00|-2.00|.70
70858675|NCT00971620|141203398|SUPERIORITY_OR_OTHER|||||||0.06|||||||Wilcoxon rank sum test|||||||.06
70858676|NCT00971620|141203399|SUPERIORITY_OR_OTHER|||||||0.007|||||||WIlcoxon rank sum test|||||||.007
70858677|NCT00971620|141203400|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon rank sum test|||||||0.48
70858678|NCT00971620|141203401|SUPERIORITY_OR_OTHER|||||||0.04|||||||Wilcoxon rank sum test|||||||.04
70858679|NCT00971620|141203403|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon rank sum test|||||||.07
70858680|NCT01723696|141203422|SUPERIORITY||Mean Difference (Final Values)|12.1||||0.19|TWO_SIDED|95.0|-6.1|30.3||P-value adjusted for design factors of site, gestational age at randomization and covariates of length, race, and sex of infant.|ANCOVA|||Our targeted sample size of 218 infants with successful FEFs at 3 months of age was determined to detect with 90% power, at a significance level of 0.05, increases of 15% in mean FEF75 in the vitamin C group compared to the placebo group.||30.3|-6.1|0.19
70858681|NCT02581943|141203425|OTHER|||||||0.366|||||||Log Rank|||||||0.366
70858682|NCT02581943|141203426|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.327|||||||Wilcoxon (Mann-Whitney)|test for CD4+FoxP3||||||0.327
70858683|NCT02581943|141203426|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.142|||||||Wilcoxon (Mann-Whitney)|test for MDSC||||||0.142
70946805|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.2093|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insomnia Early - Early Night||0.1|-0.3|0.2093
70858684|NCT02581943|141203426|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.462||||||test for CD4+ICOS+|Wilcoxon (Mann-Whitney)|||||||0.462
70858685|NCT02581943|141203426|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.87||||||test for CD8+ICOS+|Wilcoxon (Mann-Whitney)|||||||0.870
70858686|NCT02581943|141203426|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.414||||||test for Plamacytoid DC|Wilcoxon (Mann-Whitney)|||||||0.414
70858687|NCT02581943|141203426|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.121||||||test for Monocytes|Wilcoxon (Mann-Whitney)|||||||0.121
70858688|NCT02581943|141203426|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.624||||||test for T cells (CD3+)|Wilcoxon (Mann-Whitney)|||||||0.624
70858689|NCT02581943|141203427|OTHER|||||||0.348|||||||Fisher Exact|||||||0.348
70858690|NCT02581943|141203428|OTHER|||||||0.63|||||||Log Rank|||||||0.63
70858691|NCT02581943|141203429|OTHER|||||||0.692|||||||Log Rank|||||||0.692
70858692|NCT02581943|141203430|OTHER|||||||0.345|||||||Fisher Exact|||||||0.345
70858693|NCT02581943|141203431|OTHER|||||||0.917|||||||Kruskal-Wallis|Test for CD8+ICOS||||||0.917
70858694|NCT02581943|141203431|OTHER|||||||0.746|||||||Kruskal-Wallis|test for MDSC||||||0.746
70858695|NCT02581943|141203431|OTHER|||||||0.302||||||test for CD4+ICOS|Kruskal-Wallis|||||||0.302
70858696|NCT02581943|141203431|OTHER|||||||0.13|||||||Kruskal-Wallis|test for CD8+ICOS+||||||0.130
70858697|NCT02581943|141203431|OTHER|||||||0.628||||||test for Plamacytoid DC|Kruskal-Wallis|||||||0.628
70858698|NCT02581943|141203431|OTHER|||||||0.567||||||test for Monocytes|Kruskal-Wallis|||||||0.567
70858699|NCT02581943|141203431|OTHER|||||||0.311||||||test for T cells (CD3+)|Kruskal-Wallis|||||||0.311
70946806|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.5189|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insomnia Early - Early Night||0.1|-0.3|0.5189
70946807|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.6617|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insomnia Early - Early Night||0.2|-0.2|0.6617
70858700|NCT00219544|141203443|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.78|STANDARD_ERROR_OF_MEAN|0.25||0.0018||95.0|-1.27|-0.3|||ANCOVA||Difference = pregabalin minus placebo|The study is powered to detect clinically significant difference of 1.2 between treatment groups in mean pain score at end of treatment. The statistical sample size calculation requires a total of 144 subjects to complete the Double-Blind phase of the study: a sample size of 72 in each treatment group will have 90% power to detect a difference in treatment mean pain scores of 1.2 assuming that the common standard deviation is 2.2 using a two group t-test with a 0.05 two-sided significance level.||-0.30|-1.27|0.0018
70858701|NCT00219544|141203446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.72|STANDARD_ERROR_OF_MEAN|0.22||0.001||95.0|-1.15|-0.3|||ANCOVA||pregabalin minus placebo|Week 5||-0.30|-1.15|0.0010
70858702|NCT00219544|141203446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.97|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001||95.0|-1.41|-0.53|||ANCOVA||pregabalin minus placebo|Week 6||-0.53|-1.41|<.0001
70858703|NCT00219544|141203446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.93|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001||95.0|-1.39|-0.47|||ANCOVA||pregabalin minus placebo|Week 7||-0.47|-1.39|<.0001
70858704|NCT00219544|141203446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.93|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001||95.0|-1.39|-0.47|||ANCOVA||pregabalin minus placebo|Week 8||-0.47|-1.39|<.0001
70858705|NCT00219544|141203446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.69|STANDARD_ERROR_OF_MEAN|0.23||0.0022||95.0|-1.14|-0.25|||ANCOVA||pregabalin minus placebo|Week 9||-0.25|-1.14|0.0022
70946808|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.2632|TWO_SIDED|95.0|-0.1|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insomnia Early - Early Night||0.3|-0.1|0.2632
71129145|NCT00286494|141763348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123||||0.349|TWO_SIDED|95.0|-0.134|0.38||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.380|-0.134|0.349
71129146|NCT00286494|141763348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.223||||0.089|TWO_SIDED|95.0|-0.034|0.479||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.479|-0.034|0.089
71129147|NCT00286494|141763349|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.815||||0.003|TWO_SIDED|95.0|1.736|13.358|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||13.358|1.736|0.003
71129148|NCT00286494|141763349|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.533|||<|0.001|TWO_SIDED|95.0|2.017|15.176|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||15.176|2.017|<0.001
70858706|NCT00219544|141203452|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|-0.71|STANDARD_ERROR_OF_MEAN|0.24||0.0031||95.0|-1.18|-0.24|||ANCOVA|||||-0.24|-1.18|0.0031
70858707|NCT00219544|141203455|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.22||0.0177||95.0|-0.94|-0.09|||ANCOVA||pregabalin minus placebo|Week 5||-0.09|-0.94|0.0177
71129149|NCT00286494|141763350|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.903||||0.029|TWO_SIDED|95.0|1.067|3.393|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||3.393|1.067|0.029
71129150|NCT00286494|141763350|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.301||||0.005|TWO_SIDED|95.0|1.291|4.1|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regiment \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||4.100|1.291|0.005
71129151|NCT00286494|141763351|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.783|||<|0.001|TWO_SIDED|95.0|1.547|5.005|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||5.005|1.547|<0.001
70858708|NCT00219544|141203455|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.87|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001||95.0|-1.31|-0.44|||ANCOVA||pregabalin minus placebo|Week 6||-0.44|-1.31|<.0001
70858709|NCT00219544|141203455|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.82|STANDARD_ERROR_OF_MEAN|0.23||0.0005||95.0|-1.28|-0.36|||ANCOVA||pregabalin minus placebo|Week 7||-0.36|-1.28|0.0005
70858710|NCT00219544|141203455|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.85|STANDARD_ERROR_OF_MEAN|0.23||0.0003||95.0|-1.31|-0.39|||ANCOVA||pregabalin minus placebo|Week 8||-0.39|-1.31|0.0003
70858711|NCT00219544|141203455|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.74|STANDARD_ERROR_OF_MEAN|0.22||0.0011||95.0|-1.18|-0.3|||ANCOVA||pregabalin minus placebo|Week 9||-0.30|-1.18|0.0011
70858712|NCT00219544|141203456|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-9.0|STANDARD_ERROR_OF_MEAN|3.3||0.0069||95.0|-15.5|-2.5|||ANCOVA|||||-2.5|-15.5|0.0069
70858713|NCT00219544|141203457|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|0.4||0.0023||95.0|-2.1|-0.5|||ANCOVA||pregabalin minus placebo|HADS-A||-0.5|-2.1|0.0023
70858714|NCT00219544|141203457|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|0.4||0.0013||95.0|-1.9|-0.5|||ANCOVA||pregabalin minus placebo|HADS-D||-0.5|-1.9|0.0013
70858715|NCT00219544|141203458|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.98|STANDARD_ERROR_OF_MEAN|3.42||0.0828||95.0|-0.79|12.75|||ANCOVA||pregabalin minus placebo|Impact||12.75|-0.79|0.0828
70858716|NCT00219544|141203458|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.49|STANDARD_ERROR_OF_MEAN|2.75||0.0197||95.0|1.05|11.94|||ANCOVA||pregabalin minus placebo|Satisfaction||11.94|1.05|0.0197
70858717|NCT00219544|141203459|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0278||95.0|||||Mantel Haenszel|||The distribution of the responses to the PGIC at EOT was compared between the 2 treatment groups using the 7 categories of the PGIC.||||0.0278
70858718|NCT00219544|141203460|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.76|STANDARD_ERROR_OF_MEAN|0.26||0.0049||95.0|-1.28|-0.23|||ANCOVA|||Pain interference||-0.23|-1.28|0.0049
70858719|NCT00219544|141203460|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.77|STANDARD_ERROR_OF_MEAN|0.26||0.0037||95.0|-1.29|-0.25|||ANCOVA|||Pain severity||-0.25|-1.29|0.0037
70858720|NCT00219544|141203461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.0719||95.0|0.0|0.11|||ANCOVA||pregabalin minus placebo|Health State Profile||0.11|-0.00|0.0719
70858721|NCT00219544|141203461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.07|STANDARD_ERROR_OF_MEAN|2.54||0.418||95.0|-2.96|7.1|||ANCOVA||pregabalin minus placebo|Visual Analog Scale||7.10|-2.96|0.4180
70858722|NCT00829933|141203496|SUPERIORITY_OR_OTHER|||||||0.429|TWO_SIDED||||||Chi-squared|||For the incidence of bleeding events, paired comparison between the DU-176b groups was performed using the χ2 test.||||0.429
70858723|NCT00829933|141203496|SUPERIORITY_OR_OTHER|||||||0.077|TWO_SIDED||||||Chi-squared|||||||0.077
70858724|NCT00829933|141203496|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|-1.5|||||TWO_SIDED|95.0|-11.2|8.1|||Wilcoxon (Mann-Whitney)|||||8.1|-11.2|
70858725|NCT00829933|141203496|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Chi-squared|||||||0.320
70858726|NCT00829933|141203496|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|2.4|||||TWO_SIDED|95.0|-7.6|12.3|||Wilcoxon (Mann-Whitney)|||||12.3|-7.6|
70858727|NCT00829933|141203496|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|7.7|||||TWO_SIDED|95.0|-2.7|18.1|||Wilcoxon (Mann-Whitney)|||||18.1|-2.7|
70858728|NCT02338336|141203502|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
70858729|NCT01986933|141203504|SUPERIORITY||Mean Difference (Final Values)|-21.39|STANDARD_ERROR_OF_MEAN|7.02||0.0027|TWO_SIDED|95.0|-35.25|-7.53||Since a hierarchical decision procedure can be regarded as a closed testing procedure, no inflation of the alpha level due to multiple comparisons was necessary, and the global 1-sided significance alpha level of 0.025 was maintained.|ANCOVA|||||-7.53|-35.25|0.0027
70858730|NCT01986933|141203504|SUPERIORITY||Mean Difference (Final Values)|-41.16|STANDARD_ERROR_OF_MEAN|7.1|<|0.0001|TWO_SIDED|95.0|-55.17|-27.15||Since a hierarchical decision procedure can be regarded as a closed testing procedure, no inflation of the alpha level due to multiple comparisons was necessary, and the global 1-sided significance alpha level of 0.025 was maintained.|ANCOVA|||||-27.15|-55.17|<0.0001
70858731|NCT01986933|141203504|SUPERIORITY||Mean Difference (Final Values)|-40.39|STANDARD_ERROR_OF_MEAN|6.95|<|0.0001|TWO_SIDED|95.0|-54.11|-26.67||Since a hierarchical decision procedure can be regarded as a closed testing procedure, no inflation of the alpha level due to multiple comparisons was necessary, and the global 1-sided significance alpha level of 0.025 was maintained.|ANCOVA|||||-26.67|-54.11|<0.0001
70858732|NCT03119701|141203513|SUPERIORITY||Odds Ratio (OR)|1.3||||0.78|TWO_SIDED|95.0|0.21|8.19||The threshold for statistical significance was p = 0.05.|Regression, Logistic|||||8.19|0.21|0.78
70858733|NCT03119701|141203514|SUPERIORITY||Odds Ratio (OR)|1.7||||0.57|TWO_SIDED|95.0|0.28|10.52||The threshold for statistical significance was p = 0.05.|Regression, Logistic|||||10.52|0.28|0.57
70858734|NCT03119701|141203515|SUPERIORITY|||||||0.08||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||||||0.08
70858735|NCT03119701|141203517|SUPERIORITY||||||>|0.999||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||||||>0.999
70858736|NCT03119701|141203520|SUPERIORITY|||||||0.362||||||The threshold for statistical significance was p = 0.05.|Mantel Haenszel|Exact Mantel-Haenszel Chi-Square Test||||||0.3620
70858737|NCT03119701|141203523|SUPERIORITY||||||<|0.0001||||||Day 2, Day 3, Day 4, Day 5, and Day 6.|ANOVA|Repeated measures ANOVA||The lower limit of quantification (LLOQ) is equal 5 ng/ml. Values below the LLOQ were set to LLOQ/2 = 2.5 ng/ml. Values over the upper limit of quantitation (ULOQ) were set to 320 ng/ml.||||<.0001
70858738|NCT03119701|141203523|SUPERIORITY|||||||0.13||||||Baseline visit|ANOVA|Repeated measures ANOVA||The lower limit of quantification (LLOQ) is equal 5 ng/ml. Values below the LLOQ were set to LLOQ/2 = 2.5 ng/ml. Values over the upper limit of quantitation (ULOQ) were set to 320 ng/ml.||||0.13
70858739|NCT03119701|141203523|SUPERIORITY|||||||0.0035||||||Day 1|ANOVA|Repeated measures ANOVA||The lower limit of quantification (LLOQ) is equal 5 ng/ml. Values below the LLOQ were set to LLOQ/2 = 2.5 ng/ml. Values over the upper limit of quantitation (ULOQ) were set to 320 ng/ml.||||0.0035
70858740|NCT03119701|141203523|SUPERIORITY|||||||0.009||||||Day 9|ANOVA|Repeated measures ANOVA||The lower limit of quantification (LLOQ) is equal 5 ng/ml. Values below the LLOQ were set to LLOQ/2 = 2.5 ng/ml. Values over the upper limit of quantitation (ULOQ) were set to 320 ng/ml.||||0.009
70858741|NCT03119701|141203523|SUPERIORITY|||||||0.1||||||Day 13|ANOVA|Repeated measures ANOVA||The lower limit of quantification (LLOQ) is equal 5 ng/ml. Values below the LLOQ were set to LLOQ/2 = 2.5 ng/ml. Values over the upper limit of quantitation (ULOQ) were set to 320 ng/ml.||||0.10
70858742|NCT03119701|141203524|SUPERIORITY|||||||0.66||||||The threshold for statistical significance was p = 0.05.|ANOVA|Repeated measures ANOVA||Patients with an observation below the lower limit of quantification (LLOQ) value at baseline for CD73 were set to have the LLOQ value (LLOQ = 4 ng/ml) at baseline for subgroup determination purposes (2-fold increase in CD73 from baseline). Values below the LLOQ were set to LLOQ/2 = 2 ng/mL.||||0.66
70858743|NCT03119701|141203525|SUPERIORITY|||||||0.3||||||The threshold for statistical significance was p = 0.05.|ANOVA|Repeated measures ANOVA||Observations of zero were imputed as 1 pg/ml before logarithmic transformation.||||0.3
70858744|NCT02043379|141203528|NON_INFERIORITY_OR_EQUIVALENCE|We used alpha level of 0.05 and power of 0.8 to calculate the sample size necessary to detect a meaningful clinical difference for our primary endpoint.||||||1||||||A p-value of \<0.05 represents the threshold for statistical significance.|Chi-squared|||||||1
70858745|NCT02043379|141203529|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||1||||||A p-value of \<0.05 represents the threshold for statistical significance.|Chi-squared|||||||1
70946809|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.274|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insomnia Middle - Middle Night||0.1|-0.3|0.2740
70858746|NCT02043379|141203530|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.38||||||A p-value of \<0.05 represents the threshold for statistical significance.|Chi-squared|||||||0.38
70946810|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.1185|TWO_SIDED|95.0|-0.3|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insomnia Middle - Middle Night||0.0|-0.3|0.1185
71129152|NCT00286494|141763351|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.917|||<|0.001|TWO_SIDED|95.0|2.147|7.146|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||7.146|2.147|<0.001
71129153|NCT00286494|141763352|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.134|||<|0.001|TWO_SIDED|95.0|2.392|7.146|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||7.146|2.392|<0.001
71129154|NCT00286494|141763352|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.247|||<|0.001|TWO_SIDED|95.0|3.027|9.094|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||9.094|3.027|<0.001
71129155|NCT00286494|141763353|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.67|||<|0.001|TWO_SIDED|95.0|1.789|7.532|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||7.532|1.789|<0.001
71129156|NCT00286494|141763353|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.693|||<|0.001|TWO_SIDED|95.0|2.303|9.56|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||9.560|2.303|<0.001
71129157|NCT00286494|141763354|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.8||||0.015|TWO_SIDED|95.0|1.3|11.107|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||11.107|1.300|0.015
71129158|NCT00286494|141763354|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.196||||0.002|TWO_SIDED|95.0|1.806|14.95|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||14.950|1.806|0.002
71129159|NCT00286494|141763355|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.959||||0.364|TWO_SIDED|95.0|0.459|8.362|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||8.362|0.459|0.364
71129160|NCT00286494|141763355|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.849||||0.146|TWO_SIDED|95.0|0.696|11.672|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||11.672|0.696|0.146
71129161|NCT00286494|141763356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.718|TWO_SIDED|95.0|-0.45|0.65||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose,baseline value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.65|-0.45|0.718
71129162|NCT00286494|141763356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.906|TWO_SIDED|95.0|-0.52|0.58||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.58|-0.52|0.906
71129163|NCT00286494|141763357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.672|TWO_SIDED|95.0|-0.5|0.78||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.78|-0.50|0.672
71129164|NCT00286494|141763357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.922|TWO_SIDED|95.0|-0.61|0.67||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.67|-0.61|0.922
71129165|NCT00286494|141763358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.607|TWO_SIDED|95.0|-0.56|0.96||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.96|-0.56|0.607
71129166|NCT00286494|141763358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.985|TWO_SIDED|95.0|-0.77|0.76||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.76|-0.77|0.985
71129167|NCT00286494|141763359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.294|TWO_SIDED|95.0|-0.37|1.22||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.22|-0.37|0.294
71129168|NCT00286494|141763359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.9|TWO_SIDED|95.0|-0.74|0.84||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.84|-0.74|0.900
71129169|NCT02524158|141763504|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|||||||0.340
71129170|NCT02524158|141763505|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|||||||0.003
71129171|NCT02524158|141763506|SUPERIORITY|||||||0.005||||||The a priori specified threshold is p \< 0.05|Mixed Models Analysis|||||||0.005
70858747|NCT02043379|141203531|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.26||||||A p-value of \<0.05 represents the threshold for statistical significance.|Chi-squared|||||||0.26
71129172|NCT02524158|141763507|SUPERIORITY|||||||0.013|||||||Mixed Models Analysis|||||||0.013
71129173|NCT02524158|141763508|SUPERIORITY|||||||0.044||||||The a priori specified threshold is p \< 0.05|ANCOVA|||||||0.044
71129174|NCT02524158|141763509|SUPERIORITY||||||<|0.01|||||||ANCOVA|||||||<0.01
71129175|NCT02524158|141763510|SUPERIORITY|||||||0.01||||||The a priori specified threshold is p \< 0.05|ANCOVA|||||||0.010
71129176|NCT02524158|141763511|SUPERIORITY|||||||0.66|||||||ANCOVA|||||||0.66
71129177|NCT02524158|141763512|SUPERIORITY||||||<|0.1|||||||Mixed Models Analysis|||||||<0.10
71129178|NCT02524158|141763513|SUPERIORITY|||||||0.202|||||||ANCOVA|||||||0.202
71129179|NCT02524158|141763514|SUPERIORITY|||||||0.369|||||||ANCOVA|||||||0.369
71129180|NCT02524158|141763515|SUPERIORITY|||||||0.5|||||||ANCOVA|||||||0.50
71129181|NCT02524158|141763516|SUPERIORITY|||||||0.067|||||||ANCOVA|||||||0.067
71129182|NCT02524158|141763518|SUPERIORITY|||||||0.071|||||||ANCOVA|||||||0.071
71129183|NCT02524158|141763519|SUPERIORITY|||||||0.92|||||||ANCOVA|||||||0.92
71129184|NCT02524158|141763520|SUPERIORITY|||||||0.036||||||The a priori specified threshold is p \< 0.05|ANCOVA|||||||0.036
71129185|NCT02524158|141763521|SUPERIORITY|||||||0.071|||||||ANCOVA|||||||0.071
71129186|NCT03100058|141763522|OTHER|Dose finding study|Mean Difference (Net)|-1.73|||<|0.0001|TWO_SIDED|95.0|-3.17|-0.29|||ANCOVA|||||-0.29|-3.17|<0.0001
71129187|NCT03100058|141763522|OTHER|Dose finding study|Median Difference (Net)|-1.93|||<|0.0001|TWO_SIDED|95.0|-3.36|-0.5|||ANCOVA|||||-0.50|-3.36|<0.0001
71129188|NCT03100058|141763522|OTHER|Dose finding study|Mean Difference (Net)|-3.3|||<|0.0001|TWO_SIDED|95.0|-4.86|-1.75|||ANCOVA|||||-1.75|-4.86|<0.0001
71129189|NCT03100058|141763522|OTHER|Dose finding study|Mean Difference (Net)|-4.42|||<|0.0001|TWO_SIDED|95.0|-5.39|-3.44|||ANCOVA|||||-3.44|-5.39|<0.0001
71129190|NCT03100058|141763522|OTHER|Dose finding study|Mean Difference (Net)|-1.14|||<|0.0001|TWO_SIDED|95.0|-2.53|-0.25|||ANCOVA|||||-0.25|-2.53|<0.0001
71129191|NCT03100058|141763522|OTHER|Dose finding study|Mean Difference (Net)|-2.74|||<|0.0001|TWO_SIDED|95.0|-4.11|-1.36|||ANCOVA|||||-1.36|-4.11|<0.0001
71129192|NCT03100058|141763522|OTHER|Dose finding study|Mean Difference (Net)|-4.11|||<|0.0001|TWO_SIDED|95.0|-5.54|-2.68|||ANCOVA|||||-2.68|-5.54|<0.0001
71129193|NCT03100058|141763522|OTHER|Dose finding study|Mean Difference (Net)|-4.48|||<|0.0001|TWO_SIDED|95.0|-5.54|-3.43|||ANCOVA|||||-3.43|-5.54|<0.0001
71129194|NCT03100058|141763523|OTHER|Dose finding study|Odds Ratio (OR)|2.38||||0.099|TWO_SIDED|95.0|0.85|6.67|||ANCOVA|||\>=5%||6.67|0.85|0.099
71129195|NCT03100058|141763523|OTHER|Dose finding study|Odds Ratio, log|1.18||||0.779|TWO_SIDED|95.0|0.36|3.84|||ANCOVA|||\>=5%||3.84|0.36|0.779
71129196|NCT03100058|141763523|OTHER|Dose finding study|Odds Ratio (OR)|3.69||||0.011|TWO_SIDED|95.0|1.35|10.11|||ANCOVA|||\>=5%||10.11|1.35|0.011
71129197|NCT03100058|141763523|OTHER|Dose finding study|Odds Ratio (OR)|5.57|||<|0.001|TWO_SIDED|95.0|2.41|12.88|||ANCOVA|||\>=5%||12.88|2.41|<.001
71129198|NCT03100058|141763523|OTHER|Dose finding study|Odds Ratio (OR)|1.15||||0.812|TWO_SIDED|95.0|0.36|3.74|||ANCOVA|||\>=5%||3.74|0.36|0.812
71129199|NCT03100058|141763523|OTHER|Dose finding study|Odds Ratio (OR)|1.94||||0.229|TWO_SIDED|95.0|0.66|5.69|||ANCOVA|||\>=5%||5.69|0.66|0.229
70858748|NCT02043379|141203532|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.42|TWO_SIDED|95.0||||A p-value of \<0.05 represents the threshold for statistical significance.|t-test, 2 sided|||24 hour post-CPB albumin||||0.42
71129200|NCT03100058|141763523|OTHER|Dose finding study|Odds Ratio (OR)|4.29||||0.004|TWO_SIDED|95.0|1.61|11.46|||ANCOVA|||\>=5%||11.46|1.61|0.004
71129201|NCT03100058|141763523|OTHER|Dose finding study|Odds Ratio (OR)|6.37|||<|0.001|TWO_SIDED|95.0|2.72|14.93|||ANCOVA|||\>=5%||14.93|2.72|<.001
71129202|NCT03100058|141763523|OTHER|Dose finding study|Odds Ratio (OR)|1.09||||0.943|TWO_SIDED|95.0|0.1|12.41|||ANCOVA|||\>=10%||12.41|0.10|0.943
71129203|NCT03100058|141763523|OTHER|Dose finding study|Odds Ratio (OR)|2.11||||0.465|TWO_SIDED|95.0|0.28|15.77|||ANCOVA|||\>=10%||15.77|0.28|0.465
71129204|NCT03100058|141763523|OTHER|Dose finding study|Odds Ratio (OR)|1.6||||0.696|TWO_SIDED|95.0|0.15|17.15|||ANCOVA|||\>=10%||17.15|0.15|0.696
71129205|NCT03100058|141763523|OTHER|Dose finding study|Odds Ratio (OR)|2.14||||0.389|TWO_SIDED|95.0|0.38|12.1|||ANCOVA|||\>=10%||12.10|0.38|0.389
71129206|NCT03100058|141763523|OTHER|Dose finding study|Odds Ratio (OR)|1.04||||0.976|TWO_SIDED|95.0|0.09|11.87|||ANCOVA|||\>=10%||11.87|0.09|0.976
71129207|NCT03100058|141763523|OTHER|Dose finding study|Odds Ratio (OR)|1.02||||0.986|TWO_SIDED|95.0|0.09|11.7|||ANCOVA|||\>=10%||11.70|0.09|0.986
71129208|NCT03100058|141763523|OTHER|Dose finding study|Odds Ratio (OR)|3.51||||0.181|TWO_SIDED|95.0|0.56|22.18|||ANCOVA|||\>=10%||22.18|0.56|0.181
71129209|NCT03100058|141763523|OTHER|Dose finding study|Odds Ratio (OR)|3.97||||0.1|TWO_SIDED|95.0|0.77|20.54|||ANCOVA|||\>=10%||20.54|0.77|0.100
71129210|NCT03100058|141763524|OTHER|Dose finding study|Odds Ratio (OR)|6.29||||0.048|TWO_SIDED|95.0|1.02|38.76|||ANCOVA|||\>=5% (Dysglycemic)||38.76|1.02|0.048
71129211|NCT03100058|141763524|OTHER|Dose finding study|Odds Ratio, log|3.94||||0.171|TWO_SIDED|95.0|0.55|28.03|||ANCOVA|||\>=5% (Dsyglycemic)||28.03|0.55|0.171
71129212|NCT03100058|141763524|OTHER|Dose finding study|Odds Ratio (OR)|7.17||||0.041|TWO_SIDED|95.0|1.09|47.27|||ANCOVA|||\>=5% (Dysglycemic)||47.27|1.09|0.041
71129213|NCT03100058|141763524|OTHER|Dose finding study|Odds Ratio (OR)|11.89||||0.003|TWO_SIDED|95.0|2.32|60.93|||ANCOVA|||\>=5% (Dysglycemic)||60.93|2.32|0.003
71129214|NCT03100058|141763524|OTHER|Dose finding study|Odds Ratio (OR)|0.96||||0.976|TWO_SIDED|95.0|0.08|11.72|||ANCOVA|||\>=5% (Dysglycemic)||11.72|0.08|0.976
71129215|NCT03100058|141763524|OTHER|Dose finding study|Odds Ratio (OR)|8.78||||0.022|TWO_SIDED|95.0|1.37|56.44|||ANCOVA|||\>=5% (Dysglycemic)||56.44|1.37|0.022
71129216|NCT03100058|141763524|OTHER|Dose finding study|Odds Ratio (OR)|7.5||||0.032|TWO_SIDED|95.0|1.2|46.99|||ANCOVA|||\>=5% (Dysglycemic)||46.99|1.20|0.032
71129217|NCT03100058|141763524|OTHER|Dose finding study|Odds Ratio (OR)|11.28||||0.005|TWO_SIDED|95.0|2.11|60.46|||ANCOVA|||\>=5% (Dysglycemic)||60.46|2.11|0.005
71129218|NCT03100058|141763524|OTHER|Dose finding study|Odds Ratio (OR)|3.21||||0.227|TWO_SIDED|95.0|0.48|21.28|||ANCOVA|||\>=5% (Normoglycemic)||21.28|0.48|0.227
71129219|NCT03100058|141763524|OTHER|Dose finding study|Odds Ratio (OR)|0.69||||0.763|TWO_SIDED|95.0|0.06|7.85|||ANCOVA|||\>=5% (Normoglycemic)||7.85|0.06|0.763
71129220|NCT03100058|141763524|OTHER|Dose finding study|Odds Ratio (OR)|4.68||||0.095|TWO_SIDED|95.0|0.76|28.7|||ANCOVA|||\>=5% (Normoglycemic)||28.70|0.76|0.095
71129221|NCT03100058|141763524|OTHER|Dose finding study|Odds Ratio (OR)|5.33||||0.033|TWO_SIDED|95.0|1.14|24.83|||ANCOVA|||\>=5% (Normoglycemic)||24.83|1.14|0.033
71129222|NCT03100058|141763524|OTHER|Dose finding study|Odds Ratio (OR)|0.72||||0.788|TWO_SIDED|95.0|0.06|8.1|||ANCOVA|||\>=5% (Normoglycemic)||8.10|0.06|0.788
71129223|NCT03100058|141763524|OTHER|Dose finding study|Odds Ratio (OR)|0.68||||0.751|TWO_SIDED|95.0|0.06|7.62|||ANCOVA|||\>=5% (Normoglycemic)||7.62|0.06|0.751
71129224|NCT03100058|141763524|OTHER|Dose finding study|Odds Ratio (OR)|8.05||||0.027|TWO_SIDED|95.0|1.27|51.09|||ANCOVA|||\>=5% (Normoglycemic)||51.09|1.27|0.027
71129225|NCT03100058|141763524|OTHER|Dose finding study|Odds Ratio (OR)|6.64||||0.023|TWO_SIDED|95.0|1.3|34.0|||ANCOVA|||\>=5% (Normoglycemic)||34.00|1.30|0.023
71129226|NCT03100058|141763524|OTHER|Dose finding study|Odds Ratio (OR)|0.48||||0.528|TWO_SIDED|95.0|0.05|4.78|||ANCOVA|||\>=5% (T2DM)||4.78|0.05|0.528
71129227|NCT03100058|141763524|OTHER|Dose finding study|Odds Ratio (OR)|1.05||||0.958|TWO_SIDED|95.0|0.17|6.68|||ANCOVA|||\>=5% (T2DM)||6.68|0.17|0.958
71129228|NCT03100058|141763524|OTHER|Dose finding study|Odds Ratio (OR)|1.7||||0.546|TWO_SIDED|95.0|0.3|9.49|||ANCOVA|||\>=5% (T2DM)||9.49|0.30|0.546
71129229|NCT03100058|141763524|OTHER|Dose finding test|Odds Ratio (OR)|3.09||||0.098|TWO_SIDED|95.0|0.81|11.75|||ANCOVA|||\>=5% (T2DM)||11.75|0.81|0.098
71129230|NCT03100058|141763524|OTHER|Dose finding study|Odds Ratio (OR)|1.64||||0.563|TWO_SIDED|95.0|0.31|8.7|||ANCOVA|||\>=5% (T2DM)||8.70|0.31|0.563
71129231|NCT03100058|141763524|OTHER|Dose finding study|Odds Ratio (OR)|0.55||||0.61|TWO_SIDED|95.0|0.06|5.38|||ANCOVA|||\>=5% (T2DM)||5.38|0.06|0.610
71129232|NCT03100058|141763524|OTHER|Dose finding study|Odds Ratio (OR)|1.71||||0.528|TWO_SIDED|95.0|0.32|9.16|||ANCOVA|||\>=5% (T2DM)||9.16|0.32|0.528
71129233|NCT03100058|141763524|OTHER|Dose finding study|Odds Ratio (OR)|4.55||||0.023|TWO_SIDED|95.0|1.23|16.9|||ANCOVA|||\>=5% (T2DM)||16.90|1.23|0.023
71129234|NCT03100058|141763525|OTHER|Dose finding study|Median Difference (Net)|-0.8||||0.47|TWO_SIDED|95.0|-2.96|1.37|||ANCOVA|||||1.37|-2.96|0.470
71129235|NCT03100058|141763525|OTHER|Dose finding study|Median Difference (Net)|-1.4||||0.199|TWO_SIDED|95.0|-3.64|0.76|||ANCOVA|||||0.76|-3.64|0.199
71129236|NCT03100058|141763525|OTHER|Dose finding study|Median Difference (Net)|-1.4|||<|0.001|TWO_SIDED|95.0|-3.64|0.76|||ANCOVA|||||0.76|-3.64|<0.001
71129237|NCT03100058|141763525|OTHER|Dose finding study|Mean Difference (Net)|-1.4||||0.206|TWO_SIDED|95.0|-3.56|0.77|||ANCOVA|||||0.77|-3.56|0.206
71129238|NCT03100058|141763525|OTHER|Dose finding study|Median Difference (Net)|-3.0||||0.006|TWO_SIDED|95.0|-5.18|-0.88|||ANCOVA|||||-0.88|-5.18|0.006
71129239|NCT03100058|141763525|OTHER|Dose finding study|Median Difference (Net)|-3.5||||0.002|TWO_SIDED|95.0|-5.7|-1.3|||ANCOVA|||||-1.30|-5.70|0.002
71129240|NCT03100058|141763525|OTHER|Dose finding study|Mean Difference (Net)|-3.3|||<|0.001|TWO_SIDED|95.0|-5.1|-1.51|||ANCOVA|||||-1.51|-5.10|<0.001
71129241|NCT03100058|141763525|OTHER|Dose finding study|Median Difference (Net)|-0.9||||0.391|TWO_SIDED|95.0|-2.82|1.1|||ANCOVA|||||1.10|-2.82|0.391
71129242|NCT03100058|141763525|OTHER|Dose finding study|Median Difference (Net)|-2.5||||0.259|TWO_SIDED|95.0|-3.1|0.84|||ANCOVA|||||0.84|-3.10|0.259
71129243|NCT03100058|141763525|OTHER|Dose finding study|Mean Difference (Net)|-2.5||||0.048|TWO_SIDED|95.0|-4.91|-0.02|||ANCOVA|||||-0.02|-4.91|0.048
71129244|NCT03100058|141763526|OTHER|Dose finding study|Mean Difference (Net)|1.0||||0.225|TWO_SIDED|95.0|-0.62|2.61|||ANCOVA|||||2.61|-0.62|0.225
71129245|NCT03100058|141763526|OTHER|Dose finding study|Mean Difference (Net)|-1.0||||0.247|TWO_SIDED|95.0|-2.62|0.68|||ANCOVA|||||0.68|-2.62|0.247
71129246|NCT03100058|141763526|OTHER|Dose finding study|Median Difference (Net)|-2.0||||0.019|TWO_SIDED|95.0|-3.75|-0.34|||ANCOVA|||||-0.34|-3.75|0.019
71129247|NCT03100058|141763526|OTHER|Dose finding study|Mean Difference (Net)|-1.6||||0.015|TWO_SIDED|95.0|-2.96|-0.33|||ANCOVA|||||-0.33|-2.96|0.015
71129248|NCT03100058|141763526|OTHER|Dose finding study|Mean Difference (Net)|-1.3||||0.106|TWO_SIDED|95.0|-2.97|0.29|||ANCOVA|||||0.29|-2.97|0.106
70946811|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.945|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insomnia Middle - Middle Night||0.2|-0.2|0.9450
71129249|NCT03100058|141763526|OTHER|Dose finding study|Mean Difference (Net)|-1.9||||0.02|TWO_SIDED|95.0|-3.54|-0.31|||ANCOVA|||||-0.31|-3.54|0.020
71129250|NCT03100058|141763526|OTHER|Dose finding study|Mean Difference (Net)|-1.8||||0.035|TWO_SIDED|95.0|-3.44|-0.12|||ANCOVA|||||-0.12|-3.44|0.035
71129251|NCT03100058|141763526|OTHER|Dose finding study|Mean Difference (Net)|-1.9||||0.004|TWO_SIDED|95.0|-3.22|-0.61|||ANCOVA|||||-0.61|-3.22|0.004
71129252|NCT03100058|141763527|OTHER|Dose finding study|Mean Difference (Net)|0.4||||0.082|TWO_SIDED|95.0|-0.05|0.79|||ANCOVA|||||0.79|-0.05|0.082
71129253|NCT03100058|141763527|OTHER|Dose finding study|Median Difference (Net)|-0.2||||0.319|TWO_SIDED|95.0|-0.63|0.21|||ANCOVA|||||0.21|-0.63|0.319
70946812|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.6343|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insomnia Middle - Middle Night||0.1|-0.2|0.6343
71129254|NCT03100058|141763527|OTHER|Dose finding study|Mean Difference (Net)|-0.4||||0.008|TWO_SIDED|95.0|-1.05|-0.16|||ANCOVA|||||-0.16|-1.05|0.008
71129255|NCT03100058|141763527|OTHER|Dose finding study|Mean Difference (Net)|-0.4||||0.015|TWO_SIDED|95.0|-0.76|-0.08|||ANCOVA|||||-0.08|-0.76|0.015
71129256|NCT03100058|141763527|OTHER|Dose finding study|Mean Difference (Net)|-0.1||||0.707|TWO_SIDED|95.0|-0.5|0.34|||ANCOVA|||||0.34|-0.50|0.707
71129257|NCT03100058|141763527|OTHER|Dose finding study|Mean Difference (Net)|-0.2||||0.28|TWO_SIDED|95.0|-0.65|0.19|||ANCOVA|||||0.19|-0.65|0.280
71129258|NCT03100058|141763527|OTHER|Dose finding study|Mean Difference (Net)|-0.4||||0.086|TWO_SIDED|95.0|-0.8|0.05|||ANCOVA|||||0.05|-0.80|0.086
71129259|NCT03100058|141763527|OTHER|Dose finding study|Mean Difference (Net)|-0.4||||0.03|TWO_SIDED|95.0|-0.72|-0.04|||ANCOVA|||||-0.04|-0.72|0.030
71129260|NCT03100058|141763528|OTHER|Dose finding study|Mean Difference (Net)|-2.8||||0.156|TWO_SIDED|95.0|-6.64|1.07|||ANCOVA|||SBP||1.07|-6.64|0.156
71129261|NCT03100058|141763528|OTHER|Dose finding study|Mean Difference (Net)|-3.1||||0.127|TWO_SIDED|95.0|-7.11|0.89|||ANCOVA|||SBP||0.89|-7.11|0.127
71129262|NCT03100058|141763528|OTHER|Dose finding study|Mean Difference (Net)|-6.5||||0.002|TWO_SIDED|95.0|-10.52|-2.42|||ANCOVA|||SBP||-2.42|-10.52|0.002
71129263|NCT03100058|141763528|OTHER|Dose finding study|Mean Difference (Net)|-2.7||||0.089|TWO_SIDED|95.0|-5.86|0.42|||ANCOVA|||SBP||0.42|-5.86|0.089
71129264|NCT03100058|141763528|OTHER|Dose finding study|Mean Difference (Net)|-2.3||||0.245|TWO_SIDED|95.0|-6.12|1.57|||ANCOVA|||SBP||1.57|-6.12|0.245
71129265|NCT03100058|141763528|OTHER|Dose finding study|Mean Difference (Net)|-0.8||||0.678|TWO_SIDED|95.0|-4.65|3.02|||ANCOVA|||SBP||3.02|-4.65|0.678
71129266|NCT03100058|141763528|OTHER|Dose finding study|Mean Difference (Net)|-4.1||||0.04|TWO_SIDED|95.0|-8.07|-0.19|||ANCOVA|||SBP||-0.19|-8.07|0.040
71129267|NCT03100058|141763528|OTHER|Dose finding study|Mean Difference (Net)|-3.4||||0.038|TWO_SIDED|95.0|-6.61|-0.19|||ANCOVA|||SBP||-0.19|-6.61|0.038
71129268|NCT03100058|141763528|OTHER|Dose finding study|Mean Difference (Net)|-0.7||||0.601|TWO_SIDED|95.0|-3.38|1.96|||ANCOVA|||DBP||1.96|-3.38|0.601
71129269|NCT03100058|141763528|OTHER|Dose finding study|Mean Difference (Net)|-0.4||||0.76|TWO_SIDED|95.0|-3.2|2.34|||ANCOVA|||DBP||2.34|-3.20|0.760
71129270|NCT03100058|141763528|OTHER|Dose finding study|Mean Difference (Net)|-2.8||||0.051|TWO_SIDED|95.0|-5.6|0.01|||ANCOVA|||DBP||0.01|-5.60|0.051
71129271|NCT03100058|141763528|OTHER|Dose finding study|Mean Difference (Net)|-1.8||||0.105|TWO_SIDED|95.0|-3.98|0.38|||ANCOVA|||DBP||0.38|-3.98|0.105
71129272|NCT03100058|141763528|OTHER|Dose finding study|Mean Difference (Net)|0.3||||0.82|TWO_SIDED|95.0|-2.36|2.98|||ANCOVA|||DBP||2.98|-2.36|0.820
71129273|NCT03100058|141763528|OTHER|Dose finding study|Mean Difference (Net)|-1.9||||0.157|TWO_SIDED|95.0|-4.58|0.74|||ANCOVA|||DBP||0.74|-4.58|0.157
71129274|NCT03100058|141763528|OTHER|Dose finding study|Mean Difference (Net)|-0.2||||0.859|TWO_SIDED|95.0|-2.99|2.49|||ANCOVA|||DBP||2.49|-2.99|0.859
71129275|NCT03100058|141763528|OTHER|Dose finding study|Mean Difference (Net)|-2.2||||0.054|TWO_SIDED|95.0|-4.41|0.04|||ANCOVA|||DBP||0.04|-4.41|0.054
71129276|NCT03100058|141763530|OTHER|Dose finding study|Median Difference (Net)|-0.6||||0.355|TWO_SIDED|95.0|-1.84|0.66|||ANCOVA|||||0.66|-1.84|0.355
71129277|NCT03100058|141763530|OTHER|Dose finding study|Mean Difference (Net)|-0.6||||0.373|TWO_SIDED|95.0|-1.83|0.69|||ANCOVA|||||0.69|-1.83|0.373
71129278|NCT03100058|141763530|OTHER|Dose finding study|Mean Difference (Net)|-2.8|||<|0.001|TWO_SIDED|95.0|-4.36|-1.24|||ANCOVA|||||-1.24|-4.36|<0.001
71129279|NCT03100058|141763536|OTHER|Dose finding study|Mean Difference (Net)|1.07||||0.632|TWO_SIDED|95.0|0.81|1.42|||ANCOVA|||||1.42|0.81|0.632
71129280|NCT03100058|141763536|OTHER|Dose finding study|Mean Difference (Net)|1.15||||0.352|TWO_SIDED|95.0|0.86|1.55|||ANCOVA|||||1.55|0.86|0.352
71129281|NCT03100058|141763536|OTHER|Dose finding study|Mean Difference (Net)|1.41||||0.027|TWO_SIDED|95.0|1.04|1.92|||ANCOVA|||||1.92|1.04|0.027
71129282|NCT03100058|141763536|OTHER|Dose finding study|Mean Difference (Net)|1.07||||0.587|TWO_SIDED|95.0|0.85|1.35|||ANCOVA|||||1.35|0.85|0.587
71129283|NCT03100058|141763536|OTHER|Dose finding study|Mean Difference (Net)|1.1||||0.508|TWO_SIDED|95.0|0.82|1.47|||ANCOVA|||||1.47|0.82|0.508
71129284|NCT03100058|141763536|OTHER|Dose finding study|Mean Difference (Net)|1.01||||0.945|TWO_SIDED|95.0|0.76|1.34|||ANCOVA|||||1.34|0.76|0.945
71129285|NCT03100058|141763536|OTHER|Dose finding study|Mean Difference (Net)|1.08||||0.602|TWO_SIDED|95.0|0.81|1.45|||ANCOVA|||||1.45|0.81|0.602
71129286|NCT03100058|141763536|OTHER|Dose finding study|Mean Difference (Net)|1.06||||0.612|TWO_SIDED|95.0|0.84|1.35|||ANCOVA|||||1.35|0.84|0.612
71129287|NCT03100058|141763536|OTHER|Dose finding study|Median Difference (Net)|0.89||||0.382|TWO_SIDED|95.0|0.68|1.16|||ANCOVA|||||1.16|0.68|0.382
71129288|NCT03100058|141763536|OTHER|Dose finding study|Median Difference (Net)|0.87||||0.31|TWO_SIDED|95.0|0.67|1.14|||ANCOVA|||||1.14|0.67|0.310
71129289|NCT03100058|141763536|OTHER|Dose finding study|Mean Difference (Net)|0.9||||0.525|TWO_SIDED|95.0|0.65|1.25|||ANCOVA|||||1.25|0.65|0.525
71129290|NCT03100058|141763537|OTHER|Dose finding study|Mean Difference (Net)|-7.9||||0.254|TWO_SIDED|95.0|-21.37|5.65|||ANCOVA|||Triglycerides (TG)||5.65|-21.37|0.254
71129291|NCT03100058|141763537|OTHER|Dose finding study|Mean Difference (Net)|-2.7||||0.716|TWO_SIDED|95.0|-17.44|11.99|||ANCOVA|||Triglycerides (TG)||11.99|-17.44|0.716
71129292|NCT03100058|141763537|OTHER|Dose finding study|Mean Difference (Net)|-15.6||||0.038|TWO_SIDED|95.0|-30.3|-0.86|||ANCOVA|||Triglycerides (TG)||-0.86|-30.30|0.038
71129293|NCT03100058|141763537|OTHER|Dose finding study|Mean Difference (Net)|-7.0||||0.213|TWO_SIDED|95.0|-18.15|4.06|||ANCOVA|||Triglycerides (TG)||4.06|-18.15|0.213
71129294|NCT03100058|141763537|OTHER|Dose finding study|Mean Difference (Net)|-1.7||||0.806|TWO_SIDED|95.0|-15.38|11.96|||ANCOVA|||Triglycerides (TG)||11.96|-15.38|0.806
71129295|NCT03100058|141763537|OTHER|Dose finding study|Mean Difference (Net)|-2.3||||0.739|TWO_SIDED|95.0|-15.8|11.21|||ANCOVA|||Triglycerides (TG)||11.21|-15.80|0.739
71129296|NCT03100058|141763537|OTHER|Dose finding study|Mean Difference (Net)|1.4||||0.837|TWO_SIDED|95.0|-12.36|15.26|||ANCOVA|||Triglycerides (TG)||15.26|-12.36|0.837
71129297|NCT03100058|141763537|OTHER||Mean Difference (Net)|-11.4||||0.049|TWO_SIDED|95.0|-22.71|-0.07|||ANCOVA|||Triglycerides (TG)||-0.07|-22.71|0.049
71129298|NCT03100058|141763537|OTHER|Dose finding study|Median Difference (Net)|1.3||||0.764|TWO_SIDED|95.0|-7.22|9.82|||ANCOVA|||Total Cholesterol (TC)||9.82|-7.22|0.764
71129299|NCT03100058|141763537|OTHER|Dose finding study|Mean Difference (Net)|2.6||||0.571|TWO_SIDED|95.0|-6.43|11.63|||ANCOVA|||Total Cholesterol (TC)||11.63|-6.43|0.571
71129300|NCT03100058|141763537|OTHER|Dose finding study|Mean Difference (Net)|0.1||||0.987|TWO_SIDED|95.0|-9.3|9.46|||ANCOVA|||Total Cholesterol (TC)||9.46|-9.30|0.987
71129301|NCT03100058|141763537|OTHER|Dose finding study|Mean Difference (Net)|9.9||||0.006|TWO_SIDED|95.0|2.85|16.87|||ANCOVA|||Total Cholesterol (TC)||16.87|2.85|0.006
71129302|NCT03100058|141763537|OTHER|Dose finding study|Mean Difference (Net)|-3.3||||0.463|TWO_SIDED|95.0|-12.03|5.48|||ANCOVA|||Total Cholesterol (TC)||5.48|-12.03|0.463
71129303|NCT03100058|141763537|OTHER|Dose finding study|Mean Difference (Net)|0.4||||0.925|TWO_SIDED|95.0|-8.18|9.01|||ANOVA|||Total Cholesterol (TC)||9.01|-8.18|0.925
71129304|NCT03100058|141763537|OTHER|Dose finding study|Mean Difference (Net)|1.7||||0.711|TWO_SIDED|95.0|-7.19|10.53|||ANCOVA|||Total Cholesterol (TC)||10.53|-7.19|0.711
71129305|NCT03100058|141763537|OTHER|Dose finding study|Mean Difference (Net)|4.1||||0.265|TWO_SIDED|95.0|-3.1|11.26|||ANCOVA|||Total Cholesterol (TC)||11.26|-3.10|0.265
71129306|NCT03100058|141763537|OTHER|Dose finding study|Median Difference (Net)|0.0||||0.995|TWO_SIDED|95.0|-7.31|7.36|||ANCOVA|||HDL Cholesterol||7.36|-7.31|0.995
71129307|NCT03100058|141763537|OTHER|Dose finding study|Mean Difference (Net)|4.1||||0.288|TWO_SIDED|95.0|-3.52|11.81|||ANCOVA|||HDL Cholesterol||11.81|-3.52|0.288
71129308|NCT03100058|141763537|OTHER|Dose finding study|Mean Difference (Net)|4.5||||0.269|TWO_SIDED|95.0|-3.5|12.5|||ANCOVA|||HDL Cholesterol||12.50|-3.50|0.269
71129309|NCT03100058|141763537|OTHER|Dose finding study|Median Difference (Net)|7.3||||0.018|TWO_SIDED|95.0|1.23|13.27|||ANCOVA|||HDL Cholesterol||13.27|1.23|0.018
71129310|NCT03100058|141763537|OTHER|Dose finding study|Median Difference (Net)|2.2||||0.565|TWO_SIDED|95.0|-5.32|9.73|||ANCOVA|||HDL Cholesterol||9.73|-5.32|0.565
71129311|NCT03100058|141763537|OTHER|Dose finding study|Mean Difference (Net)|1.7||||0.649|TWO_SIDED|95.0|-5.67|9.09|||ANCOVA|||HDL Cholesterol||9.09|-5.67|0.649
71129312|NCT03100058|141763537|OTHER|Dose finding study|Mean Difference (Net)|0.7||||0.847|TWO_SIDED|95.0|-6.87|8.36|||ANCOVA|||HDL Cholesterol||8.36|-6.87|0.847
71129313|NCT03100058|141763537|OTHER|Dose finding study|Mean Difference (Net)|7.3||||0.02|TWO_SIDED|95.0|1.14|13.43|||ANCOVA|||HDL Cholesterol||13.43|1.14|0.020
71129314|NCT03100058|141763537|OTHER|Dose finding study|Mean Difference (Net)|-3.8||||0.579|TWO_SIDED|95.0|-17.09|9.57|||ANCOVA|||LDL Cholesterol||9.57|-17.09|0.579
71129315|NCT03100058|141763537|OTHER||Mean Difference (Net)|5.0||||0.487|TWO_SIDED|95.0|-9.08|19.02|||ANCOVA|||LDL Cholesterol||19.02|-9.08|0.487
71129316|NCT03100058|141763537|OTHER|Dose finding study|Mean Difference (Net)|-4.3||||0.561|TWO_SIDED|95.0|-18.96|10.3|||ANCOVA|||LDL Cholesterol||10.30|-18.96|0.561
71129317|NCT03100058|141763537|OTHER||Mean Difference (Net)|9.3||||0.097|TWO_SIDED|95.0|-1.68|20.25|||ANCOVA|||LDL Cholesterol||20.25|-1.68|0.097
71129318|NCT03100058|141763537|OTHER|Dose finding study|Mean Difference (Net)|-8.4||||0.227|TWO_SIDED|95.0|-22.1|5.26|||ANCOVA|||LDL Cholesterol||5.26|-22.10|0.227
71129319|NCT03100058|141763537|OTHER|Dose finding study|Mean Difference (Net)|-3.8||||0.58|TWO_SIDED|95.0|-17.22|9.64|||ANCOVA|||LDL Cholesterol||9.64|-17.22|0.580
71129320|NCT03100058|141763537|OTHER|Dose finding study|Mean Difference (Net)|-4.8||||0.494|TWO_SIDED|95.0|-18.67|9.03|||ANCOVA|||LDL Cholesterol||9.03|-18.67|0.494
71129321|NCT03100058|141763537|OTHER|Dose finding study|Mean Difference (Net)|-1.6||||0.782|TWO_SIDED|95.0|-12.81|9.65|||ANCOVA|||LDL Cholesterol||9.65|-12.81|0.782
70946813|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.3169|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insomnia Early Hours - Morning||0.1|-0.3|0.3169
70946814|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.09||0.0178|TWO_SIDED|95.0|-0.4|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insomnia Early Hours - Morning||0.0|-0.4|0.0178
70946815|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8504|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insomnia Early Hours - Morning||0.2|-0.2|0.8504
70858749|NCT02043379|141203532|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.06||||||a p-value of \<0.05 represents the threshold for test signficance|t-test, 2 sided|||48 hour post CPB albumin||||0.06
70858750|NCT02043379|141203533|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.52||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.52
70858751|NCT02043379|141203534|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.81||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||Admit Inotrope Score||||0.81
70858752|NCT02043379|141203534|NON_INFERIORITY_OR_EQUIVALENCE|power calculations were not performed on this statistical calculation||||||0.82||||||a p value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hours post-operative inotrope score||||0.82
70858753|NCT02043379|141203534|NON_INFERIORITY_OR_EQUIVALENCE|power calculations were not performed on this statistical calculation||||||0.9||||||a p value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hours post-operative inotrope score||||0.9
70946816|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.5647|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insomnia Early Hours - Morning||0.1|-0.2|0.5647
70946817|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.5914|TWO_SIDED|95.0|-0.3|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Work and Activities||0.2|-0.3|0.5914
70946818|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.4603|TWO_SIDED|95.0|-0.4|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Work and Activities||0.2|-0.4|0.4603
71129322|NCT03100058|141763537|OTHER|Dose finding study|Mean Difference (Net)|1.9||||0.816|TWO_SIDED|95.0|-13.82|17.54|||ANCOVA|||Triglycerides (TG)||17.54|-13.82|0.816
71129323|NCT03100058|141763537|OTHER|Dose finding study|Mean Difference (Net)|8.02||||0.341|TWO_SIDED|95.0|-8.13|23.42|||ANCOVA|||Triglycerides (TG)||23.42|-8.13|0.341
71129324|NCT03100058|141763537|OTHER|Dose finding study|Median Difference (Net)|9.99||||0.566|TWO_SIDED|95.0|-25.39|13.91|||ANCOVA|||Triglycerides (TG)||13.91|-25.39|0.566
71129325|NCT03100058|141763537|OTHER|Dose finding study|Mean Difference (Net)|2.98||||0.405|TWO_SIDED|95.0|-3.38|8.36|||ANCOVA|||Total Cholesterol (TC)||8.36|-3.38|0.405
71129326|NCT03100058|141763537|OTHER|Dose finding study|Median Difference (Net)|2.0||||0.511|TWO_SIDED|95.0|-3.92|7.87|||ANCOVA|||Total Cholesterol (TC)||7.87|-3.92|0.511
70858754|NCT02043379|141203534|NON_INFERIORITY_OR_EQUIVALENCE|power calculations were not performed on this statistical calculation||||||0.23||||||a p-value of \<0.05 represents the threshold for statistical signficance|Wilcoxon (Mann-Whitney)|||48 hours post-operative inotrope score||||0.23
71129327|NCT03100058|141763537|OTHER|Dose finding study|Mean Difference (Net)|2.5||||0.506|TWO_SIDED|95.0|-4.83|9.79|||ANCOVA|||Total Cholesterol (TC)||9.79|-4.83|0.506
71129328|NCT03100058|141763537|OTHER|Dose finding study|Median Difference (Net)|3.3||||0.392|TWO_SIDED|95.0|-4.2|10.7|||ANCOVA|||HDL Cholesterol||10.70|-4.20|0.392
71129329|NCT03100058|141763537|OTHER|Dose finding study|Mean Difference (Net)|3.0||||0.426|TWO_SIDED|95.0|-4.45|10.53|||ANOVA|||HDL Cholesterol||10.53|-4.45|0.426
71129330|NCT03100058|141763537|OTHER|Dose finding study|Mean Difference (Net)|8.5||||0.071|TWO_SIDED|95.0|-0.72|17.8|||ANCOVA|||HDL Cholesterol||17.80|-0.72|0.071
71129331|NCT03100058|141763537|OTHER|Dose finding study|Mean Difference (Net)|2.9||||0.498|TWO_SIDED|95.0|-5.56|11.42|||ANCOVA|||LDL Cholesterol||11.42|-5.56|0.498
71129332|NCT03100058|141763537|OTHER|Dose finding study|Median Difference (Net)|2.4||||0.586|TWO_SIDED|95.0|-6.17|10.9|||ANCOVA|||LDL Cholesterol||10.90|-6.17|0.586
71129333|NCT03100058|141763537|OTHER|Dose finding study|Mean Difference (Net)|2.1||||0.696|TWO_SIDED|95.0|-8.47|12.67|||ANCOVA|||LDL Cholesterol||12.67|-8.47|0.696
71129334|NCT00479856|141763552|SUPERIORITY_OR_OTHER||percentage of participants|33.3||||||95.0|7.5|70.1||||||||70.1|7.5|
71129335|NCT01124955|141763601|SUPERIORITY_OR_OTHER||||||,|0|||||||ANOVA|||||||0,05
71129336|NCT02828020|141763610|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0023|TWO_SIDED|95.0|1.25|2.66||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.66|1.25|0.0023
71129337|NCT02828020|141763610|SUPERIORITY||Odds Ratio (OR)|2.04||||0.0003|TWO_SIDED|95.0|1.41|2.95||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.95|1.41|0.0003
71129338|NCT02828020|141763611|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0023|TWO_SIDED|95.0|1.27|2.28||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, underlying symptom as explanatory variables.||||2.28|1.27|0.0023
71129339|NCT02828020|141763611|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0023|TWO_SIDED|95.0|1.22|2.17||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, underlying symptom as explanatory variables.||||2.17|1.22|0.0023
71129340|NCT02828020|141763612|SUPERIORITY||Odds Ratio (OR)|1.69||||0.0023|TWO_SIDED|95.0|1.28|2.23||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.23|1.28|0.0023
71129341|NCT02828020|141763612|SUPERIORITY||Odds Ratio (OR)|1.69||||0.0023|TWO_SIDED|95.0|1.28|2.21||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.21|1.28|0.0023
71129342|NCT02828020|141763613|SUPERIORITY||Odds Ratio (OR)|2.25||||0.0023|TWO_SIDED|95.0|1.65|3.07||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||3.07|1.65|0.0023
71129343|NCT02828020|141763613|SUPERIORITY||Odds Ratio (OR)|2.39||||0.0023|TWO_SIDED|95.0|1.77|3.24||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||3.24|1.77|0.0023
70858755|NCT02043379|141203535|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.49||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.49
70858756|NCT02043379|141203536|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.79||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.79
70946819|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.5637|TWO_SIDED|95.0|-0.4|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Work and Activities||0.2|-0.4|0.5637
70946820|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.4638|TWO_SIDED|95.0|-0.4|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Work and Activities||0.2|-0.4|0.4638
70946821|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.1846|TWO_SIDED|95.0|0.0|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Retardation||0.2|0.0|0.1846
70946822|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.4837|TWO_SIDED|95.0|-0.1|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Retardation||0.2|-0.1|0.4837
70946823|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.1178|TWO_SIDED|95.0|0.0|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Retardation||0.2|0.0|0.1178
71129344|NCT02828020|141763614|SUPERIORITY||Odds Ratio (OR)|1.57||||0.0577|TWO_SIDED|95.0|1.01|2.44||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.44|1.01|0.0577
71129345|NCT02828020|141763614|SUPERIORITY||Odds Ratio (OR)|1.95||||0.0037|TWO_SIDED|95.0|1.28|2.97||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.97|1.28|0.0037
71129346|NCT02828020|141763615|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0577|TWO_SIDED|95.0|1.22|2.19||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, photophobia were explanatory variables.||||2.19|1.22|0.0577
71129347|NCT02828020|141763615|SUPERIORITY||Odds Ratio (OR)|1.81||||0.0037|TWO_SIDED|95.0|1.36|2.42||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, photophobia were explanatory variables.||||2.42|1.36|0.0037
71129348|NCT02828020|141763616|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0577|TWO_SIDED|95.0|1.16|2.09||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, phonophobia were explanatory variables.||||2.09|1.16|0.0577
71129349|NCT02828020|141763616|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0577|TWO_SIDED|95.0|1.1|1.95||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, phonophobia were explanatory variables.||||1.95|1.10|0.0577
71129350|NCT02828020|141763617|SUPERIORITY||Odds Ratio (OR)|1.31||||0.0962|TWO_SIDED|95.0|0.96|1.79||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, nausea were explanatory variables.||||1.79|0.96|0.0962
71129351|NCT02828020|141763617|SUPERIORITY||Odds Ratio (OR)|1.35||||0.0962|TWO_SIDED|95.0|1.0|1.83||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, nausea were explanatory variables.||||1.83|1.00|0.0962
71129352|NCT00966550|141763618|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.0001
70946824|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.7888|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Retardation||0.1|-0.1|0.7888
70946825|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.9496|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Agitation||0.1|-0.1|0.9496
70946826|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.0497|TWO_SIDED|95.0|-0.3|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Agitation||0.0|-0.3|0.0497
71129353|NCT01128946|141763627|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|23.06|||<|0.0001|TWO_SIDED|95.0|19.63|26.48||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||26.48|19.63|<0.0001
70858757|NCT02043379|141203537|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.32||||||A p-value of \<0.05 represents the threshold for statistical significance.|t-test, 2 sided|||pre-operative IgG level||||0.32
70858758|NCT02043379|141203537|NON_INFERIORITY_OR_EQUIVALENCE|power calculations were not performed on this statistical calculation||||||0.36||||||a p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hours post-operative IgG level||||0.36
70858759|NCT02043379|141203537|NON_INFERIORITY_OR_EQUIVALENCE|power calculations were not performed on this statistical calculation|||||<|0.01||||||p-value of \<0.05 represents the threshold for statistical signficance|Wilcoxon (Mann-Whitney)|||post-operative day 3 (72 hours) IgG level||||<0.01
70858760|NCT02043379|141203537|NON_INFERIORITY_OR_EQUIVALENCE|power calculations were not performed on this statistical calculation|||||<|0.01||||||p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||post-operative day 5 (120 hours) IgG level||||<0.01
70858761|NCT02043379|141203538|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.6||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.60
70858762|NCT02043379|141203538|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.06||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.06
70858763|NCT02043379|141203538|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.06||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.06
70858764|NCT02043379|141203538|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.33||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hours post-operative||||0.33
70858765|NCT02043379|141203538|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.05||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hours post-operative||||0.05
70858766|NCT02043379|141203538|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.83||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hours post-operative||||0.83
70858767|NCT02043379|141203539|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.27||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||0 hour levels||||0.27
70858768|NCT02043379|141203539|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.34||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||4 hour level||||0.34
70858769|NCT02043379|141203539|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.14||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||8 hour level||||0.14
70946827|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.4189|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Agitation||0.1|-0.2|0.4189
70946828|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.1342|TWO_SIDED|95.0|-0.3|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Agitation||0.0|-0.3|0.1342
70858770|NCT02043379|141203539|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.13||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||12 hour level||||0.13
70858771|NCT02043379|141203539|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.02||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||24 hour level||||0.02
70858772|NCT02043379|141203540|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||1||||||A p-value of \<0.05 represents the threshold for statistical significance.|Chi-squared|||||||1
70858773|NCT02043379|141203541|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.4||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.4
70858774|NCT02043379|141203542|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.09||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||0-48 hours post-CPB||||0.09
70858775|NCT02043379|141203542|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.52||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||0-24 hours post CPB||||0.52
70858776|NCT02043379|141203543|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.72||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.72
70858777|NCT02043379|141203544|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.63||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.63
70858778|NCT02043379|141203545|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.41||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.41
70858779|NCT02043379|141203545|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.34||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.34
70858780|NCT02043379|141203545|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.47||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.47
70946829|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.9202|TWO_SIDED|95.0|-0.3|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Anxiety Psychic||0.2|-0.3|0.9202
70946830|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.026|TWO_SIDED|95.0|-0.5|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Anxiety Psychic||0.0|-0.5|0.0260
70946831|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.13||0.937|TWO_SIDED|95.0|-0.3|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Anxiety Psychic||0.2|-0.3|0.9370
70946832|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.13||0.844|TWO_SIDED|95.0|-0.3|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Anxiety Psychic||0.2|-0.3|0.8440
70946833|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.09||0.448|TWO_SIDED|95.0|-0.1|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Anxiety Somatic||0.3|-0.1|0.4480
70946834|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.6345|TWO_SIDED|95.0|-0.1|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Anxiety Somatic||0.2|-0.1|0.6345
70946835|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4123|TWO_SIDED|95.0|-0.1|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Anxiety Somatic||0.3|-0.1|0.4123
70946836|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.7523|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Anxiety Somatic||0.2|-0.2|0.7523
70946837|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.6505|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Somatic Symptoms Gastrointestinal||0.1|-0.2|0.6505
70858781|NCT02043379|141203545|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.42||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative||||0.42
70858782|NCT02043379|141203545|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.82||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative||||0.82
70858783|NCT02043379|141203545|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.44||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative||||0.44
70858784|NCT02043379|141203546|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.28||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.28
70946838|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.3674|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Somatic Symptoms Gastrointestinal||0.1|-0.3|0.3674
70946839|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.836|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Somatic Symptoms Gastrointestinal||0.2|-0.2|0.8360
71129354|NCT01128946|141763628|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.75|||<|0.0001|TWO_SIDED|95.0|7.33|14.17||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||14.17|7.33|<0.0001
71129355|NCT01128946|141763628|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|12.2|||<|0.0001|TWO_SIDED|95.0|8.74|15.67||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||15.67|8.74|<0.0001
71129356|NCT01128946|141763628|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|12.31|||<|0.0001|TWO_SIDED|95.0|8.9|15.72||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||15.72|8.90|<0.0001
71129357|NCT01128946|141763628|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.46||||0.407|TWO_SIDED|95.0|-2.0|4.91||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||4.91|-2.00|0.4070
71129358|NCT01128946|141763628|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-10.85|||<|0.0001|TWO_SIDED|95.0|-14.3|-7.4||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||-7.40|-14.30|<0.0001
71129359|NCT01128946|141763629|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|13.21|||<|0.0001|TWO_SIDED|95.0|11.46|14.96||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.||14.96|11.46|<0.0001
71129360|NCT01128946|141763629|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.79|||<|0.0001|TWO_SIDED|95.0|7.04|10.55||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.||10.55|7.04|<0.0001
71129361|NCT01128946|141763629|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.03|||<|0.0001|TWO_SIDED|95.0|6.25|9.8||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.||9.80|6.25|<0.0001
71129362|NCT01128946|141763629|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.41|||<|0.0001|TWO_SIDED|95.0|2.66|6.16||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.||6.16|2.66|<0.0001
71129363|NCT01128946|141763629|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.77||||0.3942|TWO_SIDED|95.0|-2.54|1.0||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.||1.00|-2.54|0.3942
71129364|NCT01128946|141763629|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.18|||<|0.0001|TWO_SIDED|95.0|-6.95|-3.41||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.||-3.41|-6.95|<0.0001
71129365|NCT00621140|141763630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.85|-0.53|||ANCOVA|||Linagliptin vs. Placebo||-0.53|-0.85|<0.0001
70858785|NCT02043379|141203546|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.37||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.37
70858786|NCT02043379|141203546|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.42||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.42
70946840|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.687|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Somatic Symptoms Gastrointestinal||0.1|-0.2|0.6870
70946841|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.1364|TWO_SIDED|95.0|-0.3|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: General Somatic Symptoms||0.0|-0.3|0.1364
70858787|NCT02043379|141203546|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.31||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative||||0.31
70858788|NCT02043379|141203546|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.38||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative||||0.38
70858789|NCT02043379|141203546|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.4||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative||||0.4
70858790|NCT02043379|141203547|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.1||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.1
70858791|NCT02043379|141203547|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.12||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.12
70858792|NCT02043379|141203547|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.51||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.51
70858793|NCT02043379|141203547|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.27||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative||||0.27
70858794|NCT02043379|141203547|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.88||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative||||0.88
71129366|NCT00621140|141763631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|-0.58|-0.34|||ANCOVA|||Linagliptin vs. Placebo||-0.34|-0.58|<0.0001
71129367|NCT00621140|141763632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.76|-0.47|||ANCOVA|||Linagliptin vs. Placebo||-0.47|-0.76|<0.0001
70858795|NCT02043379|141203547|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.38||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative||||0.38
70858796|NCT02043379|141203548|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.35||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.35
70858797|NCT02043379|141203548|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.39||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.39
70858798|NCT02043379|141203548|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.58||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.58
70858799|NCT02043379|141203548|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.36||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative||||0.36
70858800|NCT02043379|141203548|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.61||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative||||0.61
70858801|NCT02043379|141203548|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.38||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative||||0.38
70858802|NCT02043379|141203549|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.1||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.1
70858803|NCT02043379|141203549|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.02||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.02
70858804|NCT02043379|141203549|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.34||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.34
71129368|NCT00621140|141763633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.82|-0.49|||ANCOVA|||Linagliptin vs. Placebo||-0.49|-0.82|<0.0001
71129369|NCT00621140|141763634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.31|STANDARD_ERROR_OF_MEAN|3.59|<|0.0001||95.0|-30.37|-16.26|||ANCOVA|||Linagliptin vs. Placebo||-16.26|-30.37|<0.0001
71129370|NCT00621140|141763635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.6|STANDARD_ERROR_OF_MEAN|2.81|<|0.0001||95.0|-23.11|-12.08|||ANCOVA|||Linagliptin vs. Placebo||-12.08|-23.11|<0.0001
71129371|NCT00621140|141763636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.98|STANDARD_ERROR_OF_MEAN|3.17|<|0.0001||95.0|-27.21|-14.75|||ANCOVA|||Linagliptin vs. Placebo||-14.75|-27.21|<0.0001
71129372|NCT00621140|141763637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.36|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-27.05|-13.68|||ANCOVA|||Linagliptin vs. Placebo||-13.68|-27.05|<0.0001
71129373|NCT00621140|141763638|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.869||||0.0006||95.0|1.575|5.225|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."||5.225|1.575|0.0006
71129374|NCT00621140|141763640|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.436||||0.0323||95.0|1.078|5.507|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."||5.507|1.078|0.0323
71129375|NCT00621140|141763642|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.243|||<|0.0001||95.0|2.665|6.755|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."||6.755|2.665|<0.0001
71129376|NCT00621140|141763643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-58.38|STANDARD_DEVIATION|12.05|<|0.0001||95.0|-82.33|-34.43|||ANCOVA|||Linagliptin vs. Placebo||-34.43|-82.33|<0.0001
71129377|NCT00360568|141763660|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71129378|NCT00360568|141763661|SUPERIORITY_OR_OTHER|||||||0.394|||||||t-test, 2 sided|||||||0.394
71129379|NCT00360568|141763662|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71129380|NCT00360568|141763663|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71129381|NCT00360568|141763664|SUPERIORITY_OR_OTHER|||||||0.055|||||||t-test, 2 sided|||||||0.055
71129382|NCT00360568|141763665|SUPERIORITY_OR_OTHER|||||||0.766|||||||t-test, 2 sided|||||||0.766
71129383|NCT00360568|141763666|SUPERIORITY_OR_OTHER|||||||0.571|||||||t-test, 2 sided|||||||0.571
71129384|NCT00360568|141763667|SUPERIORITY_OR_OTHER|||||||0.583|||||||t-test, 2 sided|||||||0.583
71129385|NCT00360568|141763668|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71129386|NCT00360568|141763669|SUPERIORITY_OR_OTHER|||||||0.67|||||||t-test, 2 sided|||||||0.670
71129387|NCT00360568|141763670|SUPERIORITY_OR_OTHER|||||||0.341|||||||t-test, 2 sided|||||||0.341
71129388|NCT00360568|141763671|SUPERIORITY_OR_OTHER|||||||0.22|||||||t-test, 2 sided|||||||0.220
71129389|NCT00360568|141763672|SUPERIORITY_OR_OTHER|||||||0.174|||||||t-test, 2 sided|||||||0.174
71129390|NCT00360568|141763673|SUPERIORITY_OR_OTHER|||||||0.259|||||||t-test, 2 sided|||||||0.259
71129391|NCT00360568|141763674|SUPERIORITY_OR_OTHER|||||||0.922|||||||t-test, 2 sided|||||||0.922
71129392|NCT00360568|141763675|SUPERIORITY_OR_OTHER|||||||0.258|||||||t-test, 2 sided|||||||0.258
71129393|NCT00360568|141763676|SUPERIORITY_OR_OTHER|||||||0.104|||||||t-test, 2 sided|||||||0.104
71129394|NCT00360568|141763677|SUPERIORITY_OR_OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.650
71129395|NCT00360568|141763678|SUPERIORITY_OR_OTHER|||||||0.759|||||||t-test, 2 sided|||||||0.759
71129396|NCT00360568|141763679|SUPERIORITY_OR_OTHER|||||||0.459|||||||t-test, 2 sided|||||||0.459
71129397|NCT00360568|141763680|SUPERIORITY_OR_OTHER|||||||0.899|||||||t-test, 2 sided|||||||0.899
71129398|NCT02467842|141763681|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the upper limit of 95% confidence interval of the GMR (active comparator/experimental) was ≤1.5 for each strain.|GMR (pooled TIV/QIV)|1.02|||||TWO_SIDED|95.0|0.94|1.1||||||GMR of A/H1N1 strain (GMTs of pooled TIV/QIV)||1.10|0.94|
71129399|NCT02467842|141763681|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the upper limit of 95% confidence interval of the GMR (active comparator/experimental) was ≤1.5 for each strain.|GMR (pooled TIV/QIV)|0.94|||||TWO_SIDED|95.0|0.87|1.01||||||GMR of A/H3N2 strain (GMTs of pooled TIV/QIV)||1.01|0.87|
71129400|NCT02467842|141763681|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the upper limit of 95% confidence interval of the GMR (active comparator/experimental) was ≤1.5 for each strain.|GMR (TIV/QIV)|0.88|||||TWO_SIDED|95.0|0.82|0.95||||||GMR of B/Yamagata strain (GMTs of TIV/QIV)||0.95|0.82|
71129401|NCT02467842|141763681|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the upper limit of 95% confidence interval of the GMR (active comparator/experimental) was ≤1.5 for each strain.|GMR (TIV/QIV)|0.9|||||TWO_SIDED|95.0|0.83|0.97||||||GMR of A/H1N1 strain (GMTs of TIV/QIV)||0.97|0.83|
71129402|NCT02467842|141763682|NON_INFERIORITY|Non-inferiority of SCR was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator minus experimental) ≤10% for each strain.|Difference in percentage|-1.0|||||TWO_SIDED|95.0|-6.07|4.06||||||Diff. SCR of A/H1N1 strain (SCR of pooled TIV minus QIV)||4.06|-6.07|
71129403|NCT02467842|141763682|NON_INFERIORITY|Non-inferiority of SCR was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator minus experimental) ≤10% for each strain.|Difference in percentage|-5.02|||||TWO_SIDED|95.0|-10.08|0.04||||||Diff. SCR of A/H3N2 strain (SCR of pooled TIV minus QIV)||0.04|-10.08|
71129404|NCT02467842|141763682|NON_INFERIORITY|Non-inferiority of SCR was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator minus experimental) ≤10% for each strain.|Difference in percentage|-7.06|||||TWO_SIDED|95.0|-13.12|-1.0||||||Diff. SCR of B/Yamaga strain (SCR of TIV minus QIV)||-1.00|-13.12|
71129405|NCT02467842|141763682|NON_INFERIORITY|Non-inferiority of SCR was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator minus experimental) ≤10% for each strain.|Difference in percentage|-3.09|||||TWO_SIDED|95.0|-9.26|3.09||||||Diff. SCR of B/Victoria (SCR of TIV minus QIV)||3.09|-9.26|
71129406|NCT02467842|141763686|SUPERIORITY|Superiority of GMTs was concluded if the upper limit of 95% confidence interval for GMR (active comparator/experimental) was ≤1.0 for each B strain.|GMR (TIV/QIV)|0.75|||||TWO_SIDED|95.0|0.7|0.81||||||GMR of B/Yamagata strain (GMTs of TIV/QIV)||0.81|0.70|
71129407|NCT02467842|141763686|SUPERIORITY|Superiority of GMTs was concluded if the upper limit of 95% confidence interval for GMR (active comparator/experimental) was ≤1.0 for each B strain.|GMR (TIV/QIV)|0.75|||||TWO_SIDED|95.0|0.69|0.81||||||GMR of B/Victoria (GMTs of TIV/QIV)||0.81|0.69|
71129408|NCT02467842|141763687|SUPERIORITY|Superiority was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator-experimental) was ≤0% in each B strain.|Difference in percentage|-18.98|||||TWO_SIDED|95.0|-24.61|-13.36||||||Diff. SCR of B/Yamaga strain (SCR of TIV minus QIV)||-13.36|-24.61|
71129409|NCT02467842|141763687|SUPERIORITY|Superiority was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator-experimental) was ≤0% in each B strain.|Difference in percentage|-12.62|||||TWO_SIDED|95.0|-18.79|-6.45||||||Diff. SCR of B/Victoria strain (SCR of TIV minus QIV)||-6.45|-18.79|
71129410|NCT01990612|141763730|SUPERIORITY||Risk Ratio (RR)|0.8||||0.049|TWO_SIDED|95.0|0.64|1.0|||Chi-squared|Group sequential method to control type I error w/ Lan-DeMets characterization of O'Brien-Fleming boundary. 2-tailed p-value \<0.46 considered stat sig|One interim analysis was performed; in final analysis of the primary outcome, a two-tailed P value of less than 0.046 considered to indicate statistical significance. Since adjustment is minimal, we report 95% confidence interval for relative risk.|||1.00|0.64|0.049
71129411|NCT01990612|141763731|SUPERIORITY||Risk Ratio (RR)|0.66|||||TWO_SIDED|95.0|0.12|3.33|||||Exact confidence intervals are provided for rare outcomes. Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||3.33|0.12|
71129412|NCT01990612|141763732|SUPERIORITY||Risk Ratio (RR)|0.71|||||TWO_SIDED|95.0|0.55|0.93||||||||0.93|0.55|
71129413|NCT01990612|141763733|SUPERIORITY||Risk Ratio (RR)|0.66|||||TWO_SIDED|95.0|0.32|1.37|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||1.37|0.32|
71129414|NCT01990612|141763734|SUPERIORITY||Risk Ratio (RR)|0.7|||||TWO_SIDED|95.0|0.35|1.37|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||1.37|0.35|
71129415|NCT01990612|141763735|SUPERIORITY||Risk Ratio (RR)|2.74|||||TWO_SIDED|95.0|0.91|8.12|||||Exact confidence intervals are provided for rare outcomes. Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||8.12|0.91|
70858805|NCT02043379|141203549|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.35||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative||||0.35
71129416|NCT01990612|141763736|SUPERIORITY||Risk Ratio (RR)|0.74|||||TWO_SIDED|95.0|0.31|1.76|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||1.76|0.31|
71129417|NCT01990612|141763737|SUPERIORITY||Risk Ratio (RR)|0.65|||||TWO_SIDED|95.0|0.35|1.19|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||1.19|0.35|
71129418|NCT01990612|141763738|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.38|1.55|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||1.55|0.38|
71129419|NCT01990612|141763739|SUPERIORITY||Risk Ratio (RR)|1.28|||||TWO_SIDED|95.0|0.48|3.42|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||3.42|0.48|
71129420|NCT01990612|141763740|SUPERIORITY||Risk Ratio (RR)|0.4|||||TWO_SIDED|95.0|0.06|1.79|||||Exact confidence intervals are provided for rare outcomes. Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||1.79|0.06|
71129421|NCT01990612|141763741|SUPERIORITY||Risk Ratio (RR)|0.84|||<|0.001|TWO_SIDED|95.0|0.76|0.93||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||||0.93|0.76|<0.001
71129422|NCT01990612|141763742|SUPERIORITY||Risk Ratio (RR)|0.58||||0.02|TWO_SIDED|95.0|0.36|0.92||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||||0.92|0.36|0.02
71129423|NCT01990612|141763743|SUPERIORITY||Risk Ratio (RR)|0.85||||0.07|TWO_SIDED|95.0|0.72|1.01|||Chi-squared|||||1.01|0.72|0.07
71129424|NCT01990612|141763744|SUPERIORITY||Risk Ratio (RR)|0.94||||0.35|TWO_SIDED|95.0|0.83|1.07|||Chi-squared|||||1.07|0.83|0.35
71129425|NCT01990612|141763745|SUPERIORITY||Risk Ratio (RR)|1.15||||0.33|TWO_SIDED|95.0|0.87|1.52|||Chi-squared|||||1.52|0.87|0.33
71129426|NCT01990612|141763747|SUPERIORITY||Risk Ratio (RR)|0.5||||0.26|TWO_SIDED|95.0|0.13|1.55|||Chi-squared||Exact confidence intervals are provided for rare outcomes.|||1.55|0.13|0.26
71129427|NCT01990612|141763748|SUPERIORITY||Risk Ratio (RR)|0.64|||<|0.001|TWO_SIDED|95.0|0.56|0.74||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||||0.74|0.56|<0.001
71129428|NCT01990612|141763749|SUPERIORITY||Risk Ratio (RR)|1.03||||0.81|TWO_SIDED|95.0|0.82|1.29|||Chi-squared|||||1.29|0.82|0.81
71129429|NCT01990612|141763750|SUPERIORITY||||||<|0.001||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||Analysis for 6-96 hours after delivery||||<0.001
71129430|NCT01990612|141763750|SUPERIORITY|||||||0.01||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||Analysis for 4-8 weeks after delivery||||0.01
71129431|NCT01990612|141763751|SUPERIORITY||||||<|0.001||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||Analysis for Worst labor pain score||||<0.001
71129432|NCT01990612|141763751|SUPERIORITY||||||<|0.001||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||Analysis for Overall labor pain score||||<0.001
70946842|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.1578|TWO_SIDED|95.0|-0.3|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: General Somatic Symptoms||0.0|-0.3|0.1578
71129433|NCT01990612|141763752|SUPERIORITY||Risk Ratio (RR)|0.76||||0.15|TWO_SIDED|95.0|0.53|1.1|||Chi-squared|||||1.10|0.53|0.15
71129434|NCT01990612|141763753|SUPERIORITY||Risk Ratio (RR)|1.99||||1|TWO_SIDED|95.0|0.26|26.8|||Chi-squared|The P-values has not been adjusted for multiplicity of comparisons of secondary outcomes.|Exact confidence intervals are provided for rare outcomes.|||26.8|0.26|1.00
71129435|NCT01990612|141763755|SUPERIORITY|||||||0.01|||||||Cochran-Armitage trend test|||||||0.01
71129436|NCT01990612|141763756|SUPERIORITY||Risk Ratio (RR)|0.92||||0.56|TWO_SIDED|95.0|0.68|1.23|||Chi-squared|||||1.23|0.68|0.56
71129437|NCT01990612|141763757|SUPERIORITY||Risk Ratio (RR)|0.9||||0.56|TWO_SIDED|95.0|0.64|1.28|||Chi-squared|||||1.28|0.64|0.56
71129438|NCT01990612|141763758|SUPERIORITY||Risk Ratio (RR)|0.79||||0.75|TWO_SIDED|95.0|0.2|2.74|||Chi-squared||Exact confidence intervals are provided for rare outcomes.|||2.74|0.20|0.75
71129439|NCT01990612|141763759|SUPERIORITY||Risk Ratio (RR)|1.01||||0.91|TWO_SIDED|95.0|0.81|1.27|||Chi-squared|||||1.27|0.81|0.91
71129440|NCT01990612|141763760|SUPERIORITY||Risk Ratio (RR)|1.05||||0.84|TWO_SIDED|95.0|0.66|1.66|||Chi-squared|||||1.66|0.66|0.84
71129441|NCT01990612|141763761|SUPERIORITY||Risk Ratio (RR)|0.9||||0.13|TWO_SIDED|95.0|0.79|1.03|||Chi-squared|||||1.03|0.79|0.13
71129442|NCT01990612|141763762|SUPERIORITY||||||<|0.001|||||||Wilcoxon Rank-Sum|||||||<0.001
71129443|NCT01990612|141763763|SUPERIORITY|||||||0.01||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Cochran-Armitage trend test|||||||0.01
71129444|NCT01990612|141763764|SUPERIORITY|||||||0.002||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Cochran-Armitage trend test|||||||0.002
71129445|NCT01990612|141763766|OTHER||Odds Ratio, log|1.01||||0.88|TWO_SIDED|95.0|0.89|1.15||Odds ratios from multinomial logistic regression.|Regression, Logistic|||Multinomial logistic regression using participants who are breastfeeding only as the reference group. This analysis compares the participants who are breastfeeding and formula feeding to participants who are only breastfeeding.||1.15|0.89|0.88
71129446|NCT01990612|141763766|OTHER||Odds Ratio, log|0.98||||0.78|TWO_SIDED|95.0|0.86|1.12|||Regression, Logistic|||Multinomial logistic regression using participants who are breastfeeding only as the reference group. This analysis compares the participants who are only formula feeding to participants who are only breastfeeding.||1.12|0.86|0.78
71129447|NCT00360724|141763776|SUPERIORITY_OR_OTHER||F statistics|9.43||||0.003|||||||Repeated Measures ANOVA|df 1,55|time X Drug group, f=9.43,df 1,55, p=.003|Repeated measures ANOVA was used to compare measures between baseline and week 10.||||.003
71129448|NCT00360724|141763778|SUPERIORITY_OR_OTHER||F statistics|8.72||||0.05|||||||Repeated Measures ANOVA|d.f. 1,55|Time x Treatment: F=8.72, d.f=1,55, p=0.05|Repeated measures ANOVA was used to compare measures between baseline and week 10.||||0.05
71129449|NCT00360724|141763779|SUPERIORITY_OR_OTHER||F statistics|5.33||||0.025|||||||Repeated measures ANOVA|d.f. 1,55||Repeated measures ANOVA was used to compare measures between baseline and week 10.||||0.025
71129450|NCT00360724|141763780|SUPERIORITY_OR_OTHER||F statistics|0.26||||0.6|||||||Repeated measures ANOVA|d.f.=1,55||Repeated measures ANOVA was used to compare measures between baseline and week 10.||||0.6
71129451|NCT00360724|141763785|OTHER||Mean Difference (Final Values)|4.0||||0.002|TWO_SIDED||||||t-test, 2 sided|||||||0.002
71129452|NCT00360724|141763786|OTHER||Mean Difference (Final Values)|0.4||||0.9|TWO_SIDED||||||t-test, 2 sided|||||||0.9
71129453|NCT06037408|141763811|SUPERIORITY||Mean Difference (Final Values)|-57.13|STANDARD_ERROR_OF_MEAN|2.759||0.0001|TWO_SIDED|95.0|-63.99|-50.27||Sidak's test was used to adjust for multiple comparisons.|ANOVA|Degrees of freedom, 42.19||||-50.27|-63.99|0.0001
71129454|NCT06037408|141763812|SUPERIORITY||Mean Difference (Final Values)|25.12|STANDARD_ERROR_OF_MEAN|4.459|<|0.0001|TWO_SIDED|95.0|13.26|36.99|||ANOVA|Degrees of freedom, 28.16.||||36.99|13.26|<0.0001
71129455|NCT00118430|141763868|SUPERIORITY_OR_OTHER||||||<|0.001||||||This reported p-value was calculated (and does not merely represent the threshold for significance.|Mixed Models Analysis|||||||<0.001
71129456|NCT00118430|141763869|SUPERIORITY_OR_OTHER||||||<|0.001||||||This reported p-value was calculated (and does not merely represent the threshold for significance.|Mixed Models Analysis|||||||< 0.001
71129457|NCT00118430|141763870|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71129458|NCT00118430|141763871|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Poisson|||||||<0.001
70858806|NCT02043379|141203549|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.67||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative||||0.67
71129459|NCT00659230|141763872|SUPERIORITY_OR_OTHER||Effect Size|-0.18||||0.723|TWO_SIDED|90.0|-0.64|0.27|||ANOVA||Effect size (ES) for change in CAPS-D score relative to baseline was calculated according to the method of Cohen.|The analysis was conducted using a repeated-measures analysis of variance (ANOVA) model. The model consisted of two factors - treatment at two levels and time (5 time points including baseline) and group by time interaction.||0.27|-0.64|0.723
71129460|NCT00659230|141763873|SUPERIORITY||Effect Size|-0.07||||0.54|TWO_SIDED|90.0|-0.52|0.39|||ANOVA||Effect size (ES) for change in CAPS-D score relative to baseline was calculated according to the method of Cohen.|||0.39|-.52|0.540
71129461|NCT00659230|141763874|SUPERIORITY||Effect size|-0.18||||0.951|TWO_SIDED|90.0|-0.64|0.27|||ANOVA||Effect size (ES) for change in CAPS-D score relative to baseline was calculated according to the method of Cohen.|||0.27|-0.64|0.951
71129462|NCT00659230|141763875|SUPERIORITY||Effect Size|0.11||||0.396|TWO_SIDED|90.0|-0.35|0.56|||ANOVA||Effect size (ES) for change in CAPS-D score relative to baseline was calculated according to the method of Cohen.|||0.56|-0.35|0.396
71129463|NCT04412707|141763889|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|Adjusted geometric mean ratio (GMR)|0.946|||||TWO_SIDED|90.0|0.849|1.053|||||CVC vs. PVC, where CVC is numerator and PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs. central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||1.053|0.849|
71129464|NCT04412707|141763890|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|Adjusted geometric mean ratio (GMR)|0.952|||||TWO_SIDED|90.0|0.861|1.053|||||CVC vs. PVC, where CVC is numerator and PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs. central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||1.053|0.861|
71129465|NCT04412707|141763891|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|Adjusted geometric mean ratio (GMR)|0.955|||||TWO_SIDED|90.0|0.863|1.058|||||CVC vs. PVC, where CVC is numerator and PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs. central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||1.058|0.863|
71129466|NCT04412707|141763893|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|adjusted geometric mean ratio (GMR)|0.948|||||TWO_SIDED|90.0|0.736|1.222|||||CVC vs PVC CVC is numerator and PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|For melflufen: Based on a geometric mean ratio (GMR) peripheral vs central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||1.222|0.736|
71129467|NCT04412707|141763893|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|[adjusted geometric mean ratio (GMR)]|0.846|||||TWO_SIDED|90.0|0.748|0.957|||||CVC vs PVC CVC is numerator and PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|For desmethyl-melflufen: Based on a geometric mean ratio (GMR) peripheral vs central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||0.957|0.748|
70946843|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.9062|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: General Somatic Symptoms||0.2|-0.2|0.9062
71129468|NCT04412707|141763894|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|adjusted geometric mean ratio (GMR)|0.877|||||TWO_SIDED|90.0|0.684|1.126|||||Data above refer to meflufen. CVC vs PVC CVC is numerator, PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||1.126|0.684|
70858807|NCT02043379|141203549|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.47||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative||||0.47
70858808|NCT02043379|141203550|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.46||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.46
70858809|NCT02043379|141203550|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.04||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.04
70858810|NCT02043379|141203550|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.14||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.14
70858811|NCT02043379|141203550|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.82||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative||||0.82
70858812|NCT02043379|141203550|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.9||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative||||0.9
70946844|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.8596|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: General Somatic Symptoms||0.2|-0.2|0.8596
70858813|NCT02043379|141203550|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.78||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative||||0.78
70858814|NCT02043379|141203551|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.37||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||0 hour level||||0.37
70858815|NCT02043379|141203551|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.47||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||4 hour level||||0.47
70858816|NCT02043379|141203551|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.47||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||8 hour level||||0.47
70858817|NCT02043379|141203551|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.79||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||12 hour level||||0.79
70858818|NCT02043379|141203551|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.04||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||24 hour level||||0.04
70946845|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.9488|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Genital Symptoms||0.2|-0.2|0.9488
70858819|NCT02043379|141203552|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.43||||||A p-value of \<0.05 represents the threshold for statistical significance.|t-test, 2 sided|||pre-operative||||0.43
70858820|NCT02043379|141203552|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.68||||||A p-value of \<0.05 represents the threshold for statistical significance|t-test, 2 sided|||max||||0.68
70858821|NCT02043379|141203553|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.87||||||A p-value of \<0.05 represents the threshold for statistical significance.|t-test, 2 sided|||pre-operative||||0.87
70858822|NCT02043379|141203553|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.79||||||A p-value of \<0.05 represents the threshold for statistical significance|t-test, 2 sided|||24 hour post-operative max||||0.79
70858823|NCT00491556|141203559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.08|STANDARD_DEVIATION|5.13|<|0.0001|TWO_SIDED|95.0|-12.2|-7.97|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48|Null hypothesis is no changes between Baseline and Week 48.||-7.97|-12.20|<0.0001
70858824|NCT00491556|141203560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.81|STANDARD_DEVIATION|5.0||0.0834|TWO_SIDED|95.0|-3.87|0.26|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152|Null hypothesis is no changes between Week 48 and Week 152||0.26|-3.87|0.0834
70858825|NCT00491556|141203561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-317.36|STANDARD_DEVIATION|176.07|<|0.0001|TWO_SIDED|95.0|-390.04|-244.68|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48|Null hypothesis is no changes between Baseline and Week 48.||-244.68|-390.04|<0.0001
70858826|NCT00491556|141203562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.2|STANDARD_DEVIATION|242.38||0.6222|TWO_SIDED|95.0|-124.25|75.85|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152|Null hypothesis is no changes between Week 48 and Week 152||75.85|-124.25|0.6222
70858827|NCT00491556|141203563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-58.79|STANDARD_DEVIATION|152.57||0.0781|TWO_SIDED|95.0|-124.77|7.18|||t-test, 2 sided|||Null hypothesis is no changes between Baseline and Week 48.||7.18|-124.77|0.0781
70858828|NCT00491556|141203564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-103.53|STANDARD_DEVIATION|176.61||0.0102|TWO_SIDED|95.0|-179.9|-27.16|||t-test, 2 sided|||Null hypothesis is no changes between Week 48 and Week 152||-27.16|-179.90|0.0102
70858829|NCT00491556|141203565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.13|STANDARD_DEVIATION|56.72||0.1616|TWO_SIDED|95.0|-41.66|7.4|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48|Null hypothesis is no changes between Baseline and Week 48.||7.40|-41.66|0.1616
70946846|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.1514|TWO_SIDED|95.0|-0.3|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Genital Symptoms||0.0|-0.3|0.1514
70946847|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.5796|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Genital Symptoms||0.1|-0.2|0.5796
70858830|NCT00491556|141203566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.08|STANDARD_DEVIATION|75.17||0.0117|TWO_SIDED|95.0|-75.59|-10.58|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152|Null hypothesis is no changes between Week 48 and Week 152||-10.58|-75.59|0.0117
70858831|NCT00491556|141203567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-76.92|STANDARD_DEVIATION|56.31|<|0.0001|TWO_SIDED|95.0|-101.27|-52.57|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48|Null hypothesis is no changes between Week 48 and Week 152||-52.57|-101.27|< 0.0001
70946848|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4739|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Genital Symptoms||0.1|-0.3|0.4739
70858832|NCT00491556|141203568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.87|STANDARD_DEVIATION|68.75||0.2519|TWO_SIDED|95.0|-12.86|46.6|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152|Null hypothesis is no changes between Week 48 and Week 152||46.60|-12.86|0.2519
70858833|NCT00491556|141203569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-126.79|STANDARD_DEVIATION|105.61|<|0.0001|TWO_SIDED|95.0|-172.46|-81.12|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||-81.12|-172.46|< 0.0001
70858834|NCT00491556|141203570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|87.64|STANDARD_DEVIATION|97.71||0.0003|TWO_SIDED|95.0|45.39|129.9|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||129.90|45.39|0.0003
70858835|NCT00491556|141203571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.46|STANDARD_DEVIATION|213.77||0.3739|TWO_SIDED|95.0|-51.98|132.9|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||132.90|-51.98|0.3739
70946849|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.9439|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Hypochondriasis||0.1|-0.1|0.9439
70858836|NCT00491556|141203572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-91.86|STANDARD_DEVIATION|166.4||0.0147|TWO_SIDED|95.0|-163.82|-19.9|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||-19.90|-163.82|0.0147
70946850|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.3891|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Hypochondriasis||0.1|-0.2|0.3891
70858837|NCT00491556|141203573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|79.81|STANDARD_DEVIATION|76.07|<|0.0001|TWO_SIDED|95.0|46.92|112.71|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||112.71|46.92|< 0.0001
70946851|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.0308|TWO_SIDED|95.0|0.0|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Hypochondriasis||0.3|0.0|0.0308
70946852|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.062|TWO_SIDED|95.0|0.0|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Hypochondriasis||0.3|0.0|0.0620
70946853|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.7744|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Loss of Weight||0.1|-0.2|0.7744
70858838|NCT00491556|141203574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.4|STANDARD_DEVIATION|58.18||0.1067|TWO_SIDED|95.0|-45.56|4.76|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||4.76|-45.56|0.1067
70946854|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.9312|TWO_SIDED|95.0|-0.1|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Loss of Weight||0.2|-0.1|0.9312
70946855|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.3105|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Loss of Weight||0.1|-0.2|0.3105
70858839|NCT00491556|141203575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|90.82|STANDARD_DEVIATION|107.8||0.0005|TWO_SIDED|95.0|44.2|137.43|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||137.43|44.20|0.0005
70946856|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.8406|TWO_SIDED|95.0|-0.1|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Loss of Weight||0.2|-0.1|0.8406
70858840|NCT00491556|141203576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.49|STANDARD_DEVIATION|64.41||0.0207|TWO_SIDED|95.0|5.64|61.34|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||61.34|5.64|0.0207
71129469|NCT04412707|141763894|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|adjusted geometric mean ratio (GMR)|0.897|||||TWO_SIDED|90.0|0.819|0.982|||||Data above refer to desethyl-melflufen. CVC vs PVC CVC is numerator, PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||0.982|0.819|
71129470|NCT04412707|141763895|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|adjusted geometric mean ratio (GMR)|0.877|||||TWO_SIDED|90.0|0.684|1.124|||||Data above refer to melflufen. CVC vs PVC CVC is numerator, PVC is denominator. Linear Mixed Effect Model included terms for period, sequence \& administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||1.124|0.684|
71129471|NCT04412707|141763895|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|adjusted geometric mean ratio (GMR)|0.908|||||TWO_SIDED|90.0|0.833|0.989|||||Data above refer to desethyl-melflufen. CVC vs PVC CVC is numerator, PVC is denominator. Linear Mixed Effect Model included terms for period, sequence \& administration route as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||0.989|0.833|
71129472|NCT01115673|141763994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|469.37|||<|0.001|||||||ANOVA|Treatment and baseline pain categorical ratings were factors.|SPRID6 = 0.25 times (PRID at 15 min + PRID at 30 min + PRID at 45 min + PRID at 60 min + PRID at 75 min + PRID at 90 min) + 0.5 times (PRID at 120 minutes) + PRID at 3 hours + PRID at 4 hours + PRID at 5 hours + PRID at 6 hours.|First test H1: acetaminophen 1000 mg vs placebo at the alpha = 0.025 one-tail level; If H1 was rejected then, Test H2: acetaminophen 1000 mg vs acetaminophen 650 mg, and Test H3: acetaminophen 650 mg vs placebo; H2 and H3 were each tested at the alpha = 0.025 one-tail level.||||<0.001
71129473|NCT01115673|141763994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|102.09||||0.001|||||||ANOVA|Treatment and baseline pain categorical ratings were factors.|SPRID6 = 0.25 times (PRID at 15 min + PRID at 30 min + PRID at 45 min + PRID at 60 min + PRID at 75 min + PRID at 90 min) + 0.5 times (PRID at 120 minutes) + PRID at 3 hours + PRID at 4 hours + PRID at 5 hours + PRID at 6 hours.|First test H1: acetaminophen 1000 mg vs placebo at the alpha = 0.025 one-tail level; If H1 was rejected then, Test H2: acetaminophen 1000 mg vs acetaminophen 650 mg, and Test H3: acetaminophen 650 mg vs placebo; H2 and H3 were each tested at the alpha = 0.025 one-tail level.||||0.001
71129474|NCT01115673|141763994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|367.28|||<|0.001|||||||ANOVA|Treatment and baseline pain categorical ratings were factors.|SPRID6 = 0.25 times (PRID at 15 min + PRID at 30 min + PRID at 45 min + PRID at 60 min + PRID at 75 min + PRID at 90 min) + 0.5 times (PRID at 120 minutes) + PRID at 3 hours + PRID at 4 hours + PRID at 5 hours + PRID at 6 hours.|First test H1: acetaminophen 1000 mg vs placebo at the alpha = 0.025 one-tail level; If H1 was rejected then, Test H2: acetaminophen 1000 mg vs acetaminophen 650 mg, and Test H3: acetaminophen 650 mg vs placebo; H2 and H3 were each tested at the alpha = 0.025 one-tail level.||||<0.001
71129475|NCT01115673|141763995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|226.7|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129476|NCT01115673|141763995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|48.14||||0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.001
70858841|NCT00491556|141203577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.37|STANDARD_DEVIATION|145.62||0.2082|TWO_SIDED|95.0|-102.34|23.6|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Week 48 and Week 152.||23.60|-102.34|0.2082
70858842|NCT00491556|141203578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|86.98|STANDARD_DEVIATION|139.33||0.0067|TWO_SIDED|95.0|26.73|147.23|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||147.23|26.73|0.0067
70858843|NCT00491556|141203579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.07|STANDARD_DEVIATION|13.2|<|0.0001|TWO_SIDED|95.0|-23.78|-12.36|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||-12.36|-23.78|< 0.0001
70858844|NCT00491556|141203580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.66|STANDARD_DEVIATION|14.2||0.5815|TWO_SIDED|95.0|-4.48|7.8|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||7.80|-4.48|0.5815
70858845|NCT00491556|141203581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.24|STANDARD_DEVIATION|7.82|<|0.0001|TWO_SIDED|95.0|7.85|14.62|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||14.62|7.85|< 0.0001
70858846|NCT00491556|141203582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.87|STANDARD_DEVIATION|6.93||0.0594|TWO_SIDED|95.0|-5.87|0.12|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||0.12|-5.87|0.0594
70858847|NCT00491556|141203583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.58|STANDARD_DEVIATION|10.24||0.0001|TWO_SIDED|95.0|8.15|17.01|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||17.01|8.15|0.0001
70858848|NCT00491556|141203584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.93|STANDARD_DEVIATION|10.95||0.0995|TWO_SIDED|95.0|-0.81|8.66|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||8.66|-0.81|0.0995
70858849|NCT00491556|141203585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.95|STANDARD_DEVIATION|2.07||0.0002|TWO_SIDED|95.0|1.05|2.84|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||2.84|1.05|0.0002
70858850|NCT00491556|141203586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_DEVIATION|1.49||0.915|TWO_SIDED|95.0|-0.61|0.68|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||0.68|-0.61|0.9150
70858851|NCT00491556|141203587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.52|STANDARD_DEVIATION|13.79|<|0.0001|TWO_SIDED|95.0|-29.48|-17.55|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||-17.55|-29.48|< 0.0001
70858852|NCT00491556|141203588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.95|STANDARD_DEVIATION|16.96||0.5864|TWO_SIDED|95.0|-5.38|9.28|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||9.28|-5.38|0.5864
70858853|NCT00491556|141203589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.98|STANDARD_DEVIATION|8.48|<|0.0001|TWO_SIDED|95.0|18.31|25.65|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||25.65|18.31|< 0.0001
70858854|NCT00491556|141203590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_DEVIATION|7.25||0.1592|TWO_SIDED|95.0|-5.34|0.93|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||0.93|-5.34|0.1592
70858855|NCT00491556|141203591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.97|STANDARD_DEVIATION|11.04||0.042|TWO_SIDED|95.0|0.2|9.74|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||9.74|0.20|0.0420
70858856|NCT00491556|141203592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_DEVIATION|12.39||0.4029|TWO_SIDED|95.0|-7.56|3.16|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||3.16|-7.56|0.4029
70858857|NCT00491556|141203593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.6|STANDARD_DEVIATION|6.03|<|0.0001|TWO_SIDED|95.0|11.99|17.21|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||17.21|11.99|< 0.0001
70858858|NCT00491556|141203594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.14|STANDARD_DEVIATION|6.2||0.0239|TWO_SIDED|95.0|-5.81|-0.46|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||-0.46|-5.81|0.0239
70858859|NCT00491556|141203595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.35|STANDARD_DEVIATION|10.26|<|0.0001|TWO_SIDED|95.0|-23.79|-14.91|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||-14.91|-23.79|< 0.0001
70858860|NCT00491556|141203596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.45|STANDARD_DEVIATION|13.6||0.2363|TWO_SIDED|95.0|-9.33|2.43|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||2.43|-9.33|0.2363
70858861|NCT00491556|141203597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.69|STANDARD_DEVIATION|8.7|<|0.0001|TWO_SIDED|95.0|15.93|23.45|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||23.45|15.93|< 0.0001
70858862|NCT00491556|141203598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.03|STANDARD_ERROR_OF_MEAN|5.55||0.0929|TWO_SIDED|95.0|-4.43|0.37|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||0.37|-4.43|0.0929
70858863|NCT00491556|141203599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.53|STANDARD_DEVIATION|8.94||0.1886|TWO_SIDED|95.0|-6.4|1.34|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||1.34|-6.40|0.1886
70858864|NCT00491556|141203600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.87|STANDARD_DEVIATION|8.13||0.2831|TWO_SIDED|95.0|-1.65|5.38|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||5.38|-1.65|0.2831
70946857|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.4834|TWO_SIDED|95.0|-0.1|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insight||0.0|-0.1|0.4834
70946858|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.0961|TWO_SIDED|95.0|-0.1|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insight||0.0|-0.1|0.0961
70946859|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.829|TWO_SIDED|95.0|0.0|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insight||0.0|0.0|0.8290
70946860|NCT03672175|141393955|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.9546|TWO_SIDED|95.0|0.0|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insight||0.0|0.0|0.9546
70858865|NCT00491556|141203601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.52|STANDARD_DEVIATION|5.59|<|0.0001|TWO_SIDED|95.0|9.1|13.94|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||13.94|9.10|< 0.0001
70946861|NCT03672175|141393956|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.78||0.1308|TWO_SIDED|95.0|-2.7|0.4||MMRM with treatment, BL ISI total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||0.4|-2.7|0.1308
70946862|NCT03672175|141393956|SUPERIORITY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.77||0.0096|TWO_SIDED|95.0|-3.5|-0.5||MMRM with treatment, BL ISI total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||-0.5|-3.5|0.0096
71129477|NCT01115673|141763995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|178.56|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129478|NCT01115673|141763996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|242.67|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129479|NCT01115673|141763996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.95||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
71129480|NCT01115673|141763996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|188.72|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129481|NCT01115673|141763997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3||||0.037||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.037
71129482|NCT01115673|141763997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36||||0.294||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.294
71129483|NCT01115673|141763997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.66||||0.006||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.006
71129484|NCT01115673|141763998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.85|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129485|NCT01115673|141763998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.946||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.946
71129486|NCT01115673|141763998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.99|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129487|NCT01115673|141763999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.68|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129488|NCT01115673|141763999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06||||0.661||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.661
71129489|NCT01115673|141763999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.62|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129490|NCT01115673|141764000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.56|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129491|NCT01115673|141764000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.88||||0.13||95.0||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.13
71129492|NCT01115673|141764000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.67|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129493|NCT01115673|141764001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.97|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129494|NCT01115673|141764001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.42||||0.041||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.041
70858866|NCT00491556|141203602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.21|STANDARD_DEVIATION|5.88||0.0157|TWO_SIDED|95.0|-5.75|-0.67|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||-0.67|-5.75|0.0157
70858867|NCT00491556|141203603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.65|STANDARD_DEVIATION|12.93|<|0.0001|TWO_SIDED|95.0|-28.24|-17.06|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||-17.06|-28.24|< 0.0001
70858868|NCT00491556|141203604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.23|STANDARD_DEVIATION|15.37||0.1999|TWO_SIDED|95.0|-2.41|10.88|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||10.88|-2.41|0.1999
70858869|NCT00491556|141203605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.47|STANDARD_DEVIATION|6.81|<|0.0001|TWO_SIDED|95.0|9.52|15.41|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||15.41|9.52|< 0.0001
70858870|NCT00491556|141203606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.95|STANDARD_DEVIATION|5.12||0.0808|TWO_SIDED|95.0|-4.17|0.26|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||0.26|-4.17|0.0808
70858871|NCT00491556|141203607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7|STANDARD_DEVIATION|13.83||0.0005|TWO_SIDED|95.0|5.72|17.69|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||17.69|5.72|0.0005
70858872|NCT00491556|141203608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_DEVIATION|14.12||0.9198|TWO_SIDED|95.0|-6.41|5.81|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||5.81|-6.41|0.9198
70858873|NCT00491556|141203609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.69|STANDARD_DEVIATION|2.97|<|0.0001|TWO_SIDED|95.0|2.4|4.97|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||4.97|2.40|< 0.0001
70858874|NCT00491556|141203610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31|STANDARD_DEVIATION|2.54||0.0215|TWO_SIDED|95.0|-2.41|-0.21|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||-0.21|-2.41|0.0215
70858875|NCT02104739|141203627|SUPERIORITY|||||||0.27|||||||Non-parametric Wilcoxon paired rank sum|||Exenatide at baseline and 2 hours after ingestion of meal is compared.||||0.27
70858876|NCT02104739|141203627|SUPERIORITY|||||||0.59|||||||Non-parametric Wilcoxon paired rank sum|||Saxagliptin at baseline and 2 hours after ingestion of meal is compared.||||0.59
70858877|NCT02104739|141203627|SUPERIORITY|||||||0.51|||||||Non-parametric Wilcoxon paired rank sum|||Placebo at baseline and 2 hours after ingestion of meal is compared.||||0.51
70858878|NCT02104739|141203627|SUPERIORITY|||||||0.31|||||||Non-parametric Wilcoxon paired rank sum|||Exenatide extended-release (ER) at baseline and 2 hours after ingestion of meal is compared.||||0.31
70946863|NCT03672175|141393956|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.86||0.2674|TWO_SIDED|95.0|-0.7|2.7||MMRM with treatment, BL ISI total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||2.7|-0.7|0.2674
71129495|NCT01115673|141764001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.55|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
70858879|NCT02104739|141203629|SUPERIORITY|||||||0.02|||||||ANOVA|||||||0.02
70858880|NCT02104739|141203631|SUPERIORITY||||||<|0.05|||||||ANOVA|||The reported p-value compares exenatide and saxagliptin over all time points (2 hours, 4 hours, 6 hours).||||<0.05
70858881|NCT02104739|141203631|SUPERIORITY||||||<|0.05|||||||ANOVA|||The reported p-value compares exenatide and placebo over all time points (2 hours, 4 hours, 6 hours).||||<0.05
70858882|NCT02104739|141203633|SUPERIORITY|||||||0.018|||||||ANOVA|||||||0.018
70946864|NCT03672175|141393956|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.87||0.9771|TWO_SIDED|95.0|-1.7|1.7||MMRM with treatment, BL ISI total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||1.7|-1.7|0.9771
70858883|NCT02104739|141203635|SUPERIORITY||||||<|0.05|||||||ANOVA|||The reported p-value compares exenatide and saxagliptin over all time points (2 hours, 4 hours, 6 hours).||||<0.05
70858884|NCT02104739|141203635|SUPERIORITY||||||<|0.05|||||||ANOVA|||The reported p-value compares exenatide and placebo over all time points (2 hours, 4 hours, 6 hours).||||<0.05
70858885|NCT02104739|141203637|SUPERIORITY|||||||0.5|||||||ANOVA|||||||0.5
70858886|NCT02104739|141203638|SUPERIORITY||||||>|0.05|||||||ANOVA|||The reported p-value compares exenatide and saxagliptin over all time points (3 hours, 6 hours).||||>0.05
70858887|NCT02104739|141203638|SUPERIORITY||||||>|0.05|||||||ANOVA|||The reported p-value compares exenatide and placebo over all time points (3 hours, 6 hours).||||>0.05
70858888|NCT05772702|141203639|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||t-test, 2 sided|||HDRS-17 change score were submitted to a t-test to estimate the group difference from 0 (i.e., no change in depression symptoms from D1 to FU2). Null hypothesis: D1 == FU2||||<0.0005
70858889|NCT05772702|141203640|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||t-test, 2 sided|||HDRS-17 change score were submitted to a t-test to estimate the group difference from 0 (i.e., no change in depression symptoms from D1 to D5). Note: D5 HDRS-17 were determined prior to receiving the final treatment on D5. Null hypothesis: D1 == D5||||<0.0005
70858890|NCT05772702|141203642|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.||QIDS change score were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 QIDS surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
70858891|NCT05772702|141203643|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|||ASRM scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 ASRM surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
70858892|NCT05772702|141203644|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.||SHAPS scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 SHAPS surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
71129496|NCT01115673|141764002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|44.97|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129497|NCT01115673|141764002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.34||||0.02||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.02
71129498|NCT01115673|141764002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.63|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129499|NCT01115673|141764003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.46|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129500|NCT01115673|141764003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.08||||0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.001
71129501|NCT01115673|141764003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.38|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129502|NCT01115673|141764004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.42|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129503|NCT01115673|141764004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.83||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
71129504|NCT01115673|141764004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.59|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129505|NCT01115673|141764005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.99|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129506|NCT01115673|141764005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.57|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129507|NCT01115673|141764005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.42|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129508|NCT01115673|141764006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.04|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129509|NCT01115673|141764006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.82|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129510|NCT01115673|141764006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.22|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129511|NCT01115673|141764007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.45|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129512|NCT01115673|141764007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.58||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
71129513|NCT01115673|141764007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.87|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129514|NCT01115673|141764008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.35||||0.028||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.028
70858893|NCT05772702|141203645|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.||DASS-42 OVERALL scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 DASS-42 surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
70946865|NCT03672175|141393957|SUPERIORITY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|4.42||0.611|TWO_SIDED|95.0|-10.9|6.4||MMRM with treatment, BL sSL score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: sSL||6.4|-10.9|0.6110
71129515|NCT01115673|141764008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13||||0.462||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.462
71129516|NCT01115673|141764008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.48||||0.008||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.008
71129517|NCT01115673|141764009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.81|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
70946866|NCT03672175|141393957|SUPERIORITY||LS Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|4.19||0.0581|TWO_SIDED|95.0|-16.2|0.3||MMRM with treatment, BL sSL score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: sSL||0.3|-16.2|0.0581
70946867|NCT03672175|141393957|SUPERIORITY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|5.68||0.4493|TWO_SIDED|95.0|-15.5|6.9||MMRM with treatment, BL sSL score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28: sSL||6.9|-15.5|0.4493
71129518|NCT01115673|141764009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.907||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.907
71129519|NCT01115673|141764009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.11|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
70946868|NCT03672175|141393957|SUPERIORITY||LS Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|6.25||0.5587|TWO_SIDED|95.0|-16.0|8.6||MMRM with treatment, BL sSL score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28: sSL||8.6|-16.0|0.5587
70946869|NCT03672175|141393957|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|4.06||0.5976|TWO_SIDED|95.0|-10.1|5.8||MMRM with treatment, BL sWASO score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: sWASO||5.8|-10.1|0.5976
71129520|NCT01115673|141764010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.19|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129521|NCT01115673|141764010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32||||0.655||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.655
71129522|NCT01115673|141764010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.87|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129523|NCT01115673|141764011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.15|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129524|NCT01115673|141764011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.33||||0.155||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.155
71129525|NCT01115673|141764011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.82|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129526|NCT01115673|141764012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.69|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129527|NCT01115673|141764012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.04||||0.05||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.05
71129528|NCT01115673|141764012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.65|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129529|NCT01115673|141764013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.83|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129530|NCT01115673|141764013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.74||||0.032||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.032
71129531|NCT01115673|141764013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.1|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
70946870|NCT03672175|141393957|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|5.05||0.9421|TWO_SIDED|95.0|-9.6|10.3||MMRM with treatment, BL sWASO score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: sWASO||10.3|-9.6|0.9421
71129532|NCT01115673|141764014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|52.36|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129533|NCT01115673|141764014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.52||||0.003||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.003
71129534|NCT01115673|141764014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.84|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129535|NCT01115673|141764015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.8|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129536|NCT01115673|141764015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.04||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
71129537|NCT01115673|141764015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.75|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129538|NCT01115673|141764016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.84|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129539|NCT01115673|141764016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.82|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129540|NCT01115673|141764016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.02|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129541|NCT01115673|141764017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.4|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129542|NCT01115673|141764017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.68|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129543|NCT01115673|141764017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.72|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129544|NCT01115673|141764018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.94|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129545|NCT01115673|141764018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.4||||0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.001
71129546|NCT01115673|141764018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.55|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129547|NCT01115673|141764019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.65||||0.027||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.027
71129548|NCT01115673|141764019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.49||||0.365||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.365
71129549|NCT01115673|141764019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.14||||0.005||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.005
70946871|NCT03672175|141393957|SUPERIORITY||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|4.86||0.5581|TWO_SIDED|95.0|-6.7|12.4||MMRM with treatment, BL sWASO score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28: sWASO||12.4|-6.7|0.5581
70946872|NCT03672175|141393957|SUPERIORITY||LS Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|5.82||0.4997|TWO_SIDED|95.0|-7.5|15.4||MMRM with treatment, BL sWASO score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28: sWASO||15.4|-7.5|0.4997
70946873|NCT03672175|141393957|SUPERIORITY||LS Mean Difference|24.0|STANDARD_ERROR_OF_MEAN|10.5||0.0224|TWO_SIDED|95.0|3.4|44.7||MMRM with treatment, BL sTST score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: sTST||44.7|3.4|0.0224
70946874|NCT03672175|141393957|SUPERIORITY||LS Mean Difference|17.4|STANDARD_ERROR_OF_MEAN|10.93||0.1117|TWO_SIDED|95.0|-4.1|38.9||MMRM with treatment, BL sTST score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: sTST||38.9|-4.1|0.1117
71129550|NCT01115673|141764020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|45.65|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129551|NCT01115673|141764020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.923||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.923
71129552|NCT01115673|141764020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.1|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
70946875|NCT03672175|141393957|SUPERIORITY||LS Mean Difference|14.1|STANDARD_ERROR_OF_MEAN|14.18||0.3208|TWO_SIDED|95.0|-13.8|42.0||MMRM with treatment, BL sTST score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28: sTST||42.0|-13.8|0.3208
70946876|NCT03672175|141393957|SUPERIORITY||LS Mean Difference|10.3|STANDARD_ERROR_OF_MEAN|13.4||0.444|TWO_SIDED|95.0|-16.1|36.6||MMRM with treatment, BL sTST score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28: sTST||36.6|-16.1|0.4440
70946877|NCT03672175|141393958|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4737|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, BL sNAW score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||0.1|-0.3|0.4737
70946878|NCT03672175|141393958|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0138|TWO_SIDED|95.0|-0.4|0.0||MMRM with treatment, BL sNAW score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||0.0|-0.4|0.0138
70946879|NCT03672175|141393958|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.12||0.1098|TWO_SIDED|95.0|0.0|0.4||MMRM with treatment, BL sNAW score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28||0.4|0.0|0.1098
71129553|NCT01115673|141764021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|71.87|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129554|NCT01115673|141764021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.38||||0.653||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.653
71129555|NCT01115673|141764021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|69.49|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129556|NCT01115673|141764022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|86.71|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129557|NCT01115673|141764022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.21||||0.138||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.138
71129558|NCT01115673|141764022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|78.49|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129559|NCT01115673|141764023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|93.66|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129560|NCT01115673|141764023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.46||||0.043||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.043
71129561|NCT01115673|141764023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|82.2|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129562|NCT01115673|141764024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|94.8|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129563|NCT01115673|141764024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.08||||0.024||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.024
71129564|NCT01115673|141764024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|81.72|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129565|NCT01115673|141764025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|99.82|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129566|NCT01115673|141764025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.6||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
71129567|NCT01115673|141764025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|81.23|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129568|NCT01115673|141764026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|90.22|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129569|NCT01115673|141764026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.87||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
71129570|NCT01115673|141764026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|71.35|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129571|NCT01115673|141764027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|85.82|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129572|NCT01115673|141764027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.39|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129573|NCT01115673|141764027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|63.44|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129574|NCT01115673|141764028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|76.44|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129575|NCT01115673|141764028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.5|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129576|NCT01115673|141764028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.94|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129577|NCT01115673|141764029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|66.39|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129578|NCT01115673|141764029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.98||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
71129579|NCT01115673|141764029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|45.41|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129580|NCT01115673|141764030|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129581|NCT01115673|141764030|SUPERIORITY_OR_OTHER|||||||0.26||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.26
71129582|NCT01115673|141764030|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129583|NCT01115673|141764031|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129584|NCT01115673|141764031|SUPERIORITY_OR_OTHER|||||||0.934||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.934
71129585|NCT01115673|141764031|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129586|NCT01115673|141764032|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the log-rank test from PROC LIFETEST that compared survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects not rescuing during the 6-hour study period had their time to rescue set to 6 hours and were censored.||||<0.001
71129587|NCT01115673|141764032|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the log-rank test from PROC LIFETEST that compared survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects not rescuing during the 6-hour study period had their time to rescue set to 6 hours and were censored.||||<0.001
71129588|NCT01115673|141764032|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the log-rank test from PROC LIFETEST that compared survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects not rescuing during the 6-hour study period had their time to rescue set to 6 hours and were censored.||||<0.001
71129589|NCT01115673|141764033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.06|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129590|NCT01115673|141764033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52||||0.002||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
71129591|NCT01115673|141764033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.12|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129592|NCT01115673|141764034|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129593|NCT01115673|141764034|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
70946880|NCT03672175|141393958|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.11||0.6234|TWO_SIDED|95.0|-0.2|0.3||MMRM with treatment, BL sNAW score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28||0.3|-0.2|0.6234
70946881|NCT03672175|141393959|SUPERIORITY||Odds Ratio (OR)|0.89||||0.6741|TWO_SIDED|95.0|0.52|1.53||GEE for binary response model, with factors for treatment, BL sleep quality response, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 15||1.53|0.52|0.6741
71129594|NCT01115673|141764034|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.21|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129595|NCT01115673|141764035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|18.45|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129596|NCT01115673|141764035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.006||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.006
71129597|NCT01115673|141764035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.16|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129598|NCT01115673|141764036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129599|NCT01115673|141764036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.001
71129600|NCT01115673|141764036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.35|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71129601|NCT01593592|141764043|SUPERIORITY_OR_OTHER||percentage|0.0|||||TWO_SIDED|95.0||||||||A total of 70 patients were included; 35 in each arm. The sample size was calculated assuming eradication of H. pylori in at least 70% of treated patients, aiming to detect a difference of 30% based on a 0.80 power to detect significant difference (p =0.05, two-sided).||||
71129602|NCT01732770|141764050|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The lower bound of the 2-sided 95% confidence interval (CI) of (denosumab - zoledronic acid) was compared with the non-inferiority margin of -0.46% for assessing non-inferiority.|Treatment Difference|2.1|||<|0.0001|TWO_SIDED|95.0|1.6|2.6|||ANCOVA|The model included treatment, screening sCTX, baseline BMD, DXA machine type (Hologic or Lunar), and baseline BMD-by-machine type interaction.|Treatment difference = denosumab - zoledronic acid|A step-down sequential testing procedure was used in order to maintain the overall type I error rate at 5% for the tests of primary and secondary BMD endpoints. For the non-inferiority analysis the 1-sided significance level was 2.5%.||2.6|1.6|<0.0001
70946882|NCT03672175|141393959|SUPERIORITY||Odds Ratio (OR)|0.79||||0.3924|TWO_SIDED|95.0|0.46|1.36||GEE for binary response model, with factors for treatment, BL sleep quality response, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 15||1.36|0.46|0.3924
71129603|NCT01732770|141764051|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The lower bound of the 2-sided 95% CI) of (denosumab - zoledronic acid) was compared with the non-inferiority margin of -0.51% for assessing non-inferiority.|Treatment Difference|1.4|||<|0.0001|TWO_SIDED|95.0|1.0|1.7|||ANCOVA|The model included treatment, screening sCTX, baseline BMD, DXA machine type (Hologic or Lunar), and baseline BMD-by-machine type interaction.|Treatment difference = denosumab - zoledronic acid|A step-down sequential testing procedure was used in order to maintain the overall type I error rate at 5% for the tests of primary and secondary BMD endpoints. For the non-inferiority analysis the 1-sided significance level was 2.5%.||1.7|1.0|<0.0001
71129604|NCT01732770|141764052|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|2.1|||<|0.0001|TWO_SIDED|95.0|1.6|2.6|||ANCOVA|The model included treatment, screening sCTX, baseline BMD, DXA machine type (Hologic or Lunar), and baseline BMD-by-machine type interaction.|Treatment difference = denosumab - zoledronic acid|A step-down sequential testing procedure was used in order to maintain the overall type I error rate at 5% for the tests of primary and secondary BMD endpoints. For the superiority analysis the 2-sided significance level was 5%.||2.6|1.6|<0.0001
71129605|NCT01732770|141764053|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|1.4|||<|0.0001|TWO_SIDED|95.0|1.0|1.7|||ANCOVA|The model included treatment, screening sCTX, baseline BMD, DXA machine type (Hologic or Lunar), and baseline BMD-by-machine type interaction.|Treatment difference = denosumab - zoledronic acid|A step-down sequential testing procedure was used in order to maintain the overall type I error rate at 5% for the tests of primary and secondary BMD endpoints. For the superiority analysis the 2-sided significance level was 5%.||1.7|1.0|<0.0001
71129606|NCT01959841|141764059|NON_INFERIORITY|Wherein the non-inferiority margin was set at 10%. If the one-sided P-value was less than 0.025 between the ASP2151(400mg) once daily and the valaciclovir 1000 mg three times daily, non-inferiority of ASP2151 to valaciclovir was assumed.||||||2.41e-06|||||||Modified Farrington-Manning test|||The non-inferiority of each ASP2151 dose level versus valaciclovir was assessed stepwise using a closed testing procedure.First step analysis was performed in the ASP2151(400mg) once daily.||||0.00000241
71129607|NCT01959841|141764059|NON_INFERIORITY|Wherein the non-inferiority margin was set at 10%. If the one-sided P-value was less than 0.025 between the ASP2151(200mg) once daily and the valaciclovir 1000 mg three times daily, non-inferiority of ASP2151 to valaciclovir was assumed.||||||0.0688|||||||Modified Farrington-Manning test|||The analysis was performed in the ASP2151(200 mg) once daily only when non-inferiority of the ASP2151(400 mg) 0nce daily to valaciclovir 1000 mg three times daily was assumed.||||0.0688
71129608|NCT00666224|141764069|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.55||||0.0005|TWO_SIDED|95.0|0.4|0.77||Type of unifocal presentation at baseline, past corticosteroid treatment (Yes/No) for the initial attack prior to randomization, and center effects as covariates.|Regression, Cox|||||0.77|0.40|0.0005
71129609|NCT00666224|141764070|SUPERIORITY_OR_OTHER||Rate ratio|0.42|||<|0.0001|TWO_SIDED|95.0|0.29|0.61|||Quasi-Likelihood NB* Regression|"\*NB = Negative Binomial~Center and baseline number of enhancing lesions as covariates."||||0.61|0.29|<0.0001
71129610|NCT00666224|141764071|SUPERIORITY_OR_OTHER||Geometric means ratio|0.87||||0.0013|TWO_SIDED|95.0|0.79|0.95|||ANCOVA|Used log-transformed measurements comparing the adjusted geometric means of T2 volume. Center and baseline T2 volume used as covariates.||||0.95|0.79|0.0013
71129611|NCT00666224|141764074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41|||<|0.0001|TWO_SIDED|95.0|0.27|0.61||Type of unifocal presentation, past corticosteroid treatment (Yes/No) for the initial attack prior to randomization and center effects as covariates.|Regression, Logistic|||||0.61|0.27|<0.0001
71129612|NCT00244101|141764130|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.78|||||TWO_SIDED|95.0|0.59|1.03||||||PS group used as standard of care. Relative risk and 95 % CI calculated for PS (reference) versus ISX or NCPAP.||1.03|0.59|
71129613|NCT00244101|141764130|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.57|||||TWO_SIDED|95.0|0.25|1.27||||||PS group used as standard of care. Relative risk and 95% CI calculated for PS (reference) versus NCPAP.||1.27|0.25|
71129614|NCT00244101|141764131|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.49|1.94||||||PS group used as standard of care. Relative risk and 95 % CI calculated for PS (reference) versus ISX.||1.94|0.49|
71129615|NCT00244101|141764131|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.64|1.09||||||PS group used as standard of care. Relative risk and 95% CI calculated for PS (reference) versus NCPAP.||1.09|0.64|
71129616|NCT01959139|141764133|SUPERIORITY||Hazard Ratio (HR)|2.07|||<|0.01|TWO_SIDED|95.0|1.28|3.34|||Regression, Cox|||||3.34|1.28|<0.01
71129617|NCT01959139|141764134|SUPERIORITY||Hazard Ratio (HR)|1.74||||0.01|TWO_SIDED|95.0|1.14|2.66|||Regression, Cox|||||2.66|1.14|0.01
71129618|NCT04756804|141764140|OTHER|This was a descriptive study, no hypothesis testing was performed.|||||||||||||||||This was a descriptive study, no hypothesis testing was performed.|||
71129619|NCT00711971|141764173|SUPERIORITY_OR_OTHER|||||||0.29|||||||ANOVA|||Significance for the BDI test at 26-28 weeks||||.29
71129620|NCT00711971|141764173|SUPERIORITY_OR_OTHER|||||||0.51|||||||ANOVA|||Significance for BDI at 34-36 weeks gestation||||.51
71129621|NCT00711971|141764173|SUPERIORITY_OR_OTHER|||||||0.56|||||||ANOVA|||BDI score at 6-8 weeks postpartum||||.56
71129622|NCT00711971|141764174|SUPERIORITY_OR_OTHER|||||||0.06|||||||Fisher Exact|||Gestational diabetes mellitus||||.06
71129623|NCT00711971|141764174|SUPERIORITY_OR_OTHER|||||||0.12|||||||Fisher Exact|||Hypertension or preeclampsia||||.12
71129624|NCT00711971|141764174|SUPERIORITY_OR_OTHER|||||||0.2|||||||Fisher Exact|||Induced labor||||.20
71129625|NCT00711971|141764174|SUPERIORITY_OR_OTHER|||||||0.08|||||||Fisher Exact|||Cesarean section||||.08
71129626|NCT00711971|141764174|SUPERIORITY_OR_OTHER|||||||0.88|||||||Fisher Exact|||Spontaneous vaginal delivery||||.88
71129627|NCT00711971|141764174|SUPERIORITY_OR_OTHER|||||||0.32|||||||Fisher Exact|||Operative vaginal delivery||||.32
71129628|NCT00711971|141764175|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||||||<.0001
71129629|NCT00711971|141764176|SUPERIORITY_OR_OTHER|||||||0.81|||||||ANOVA|||||||.81
71129630|NCT00711971|141764177|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|Kruskal-Wallis test was used for outliers; Tukey multiple comparisons test was also used.||||||<.001
71129631|NCT00711971|141764178|SUPERIORITY_OR_OTHER|||||||0.39|||||||ANOVA|||||||.39
70858894|NCT05772702|141203645|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|This subscale did not require sphericity corrections.||DASS-42 DEPRESSION SUBSCORES were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 DASS-42 surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
70858895|NCT05772702|141203645|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.||DASS-42 ANXIETY SUBSCORES were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 DASS-42 surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
70858896|NCT05772702|141203645|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.||DASS-42 STRESS SUBSCORES were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 DASS-42 surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
70858897|NCT05772702|141203646|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.||||||0.021|||||||ANOVA|Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.||STAI scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 STAI surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||0.021
70858898|NCT05772702|141203647|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|||QIDS scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 QIDS surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
70858899|NCT05772702|141203648|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|||CGI severity scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 CGI assessments were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU2||||<0.0005
70858900|NCT05772702|141203648|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.||||||0.006|||||||t-test, 2 sided|||CGI improvement scores were submitted to a paired t-test to measure difference between the improvement assessment on D5 and the assessment at FU2. Note: D5 CGI assessments were completed prior to receiving the final treatment on D5. Null hypothesis: D5 = FU2||||0.006
70858901|NCT00902161|141203708|SUPERIORITY_OR_OTHER||Least Squared Mean Treatment Difference|32.0||||0.005|TWO_SIDED|95.0|15.0|49.0||There was only 1 primary hypothesis, so no multiplicity adjustment was required.|A linear mixed effect (LME) model|||The p-value is for testing the null hypothesis that the difference on Rt(65) between the \[MK-0893 1g + Propranolol\] vs. \[PBO + Propranolol\] \>=60 min. If p-value \< 0.05, then the null hypothesis is rejected at the significance level of 0.05, thus supporting the primary hypothesis that the treatment difference is less than 60 minutes.||49|15|0.005
70858902|NCT01966692|141203876|EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of geometric means for AUC0-last fell completely within (80%, 125%).|ratio (%) of geometric means|106.0||||0.4132|TWO_SIDED|90.0|99.0|114.0||The threshold for statistical significane was p=0.05.|Mixed Models Analysis||Mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Test: Fluticasone Propionate Formulation 2 (B-3.8 µm); Reference: Fluticasone Propionate Formulation 1 (A-4.5 µm); Natural log transformed AUC0-last: mixed models analysis with sequence, period, treatment as fixed effects and subject within sequence as a random effect.~All reported p-values are Bonferroni adjusted p-values."||114|99|0.4132
70858903|NCT01966692|141203876|EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of geometric means for AUC0-last fell completely within (80%, 125%).|ratio (%) of geometric means|109.0||||0.1295|TWO_SIDED|90.0|102.0|116.0||The threshold for statistical significane was p=0.05.|Mixed Models Analysis||Mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Test: Fluticasone Propionate Formulation 3 (C-3.7 µm); Reference: Fluticasone Propionate Formulation 1 (A-4.5 µm); Natural log transformed AUC0-last: mixed models analysis with sequence, period, treatment as fixed effects and subject within sequence as a random effect.~All reported p-values are Bonferroni adjusted p-values."||116|102|0.1295
70858904|NCT01966692|141203876|EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of geometric means for AUC0-last fell completely within (80%, 125%).|ratio (%) of geometric means|114.0||||0.0078|TWO_SIDED|90.0|106.0|122.0||The threshold for statistical significane was p=0.05.|Mixed Models Analysis||Mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Test: Fluticasone Propionate Formulation 3 (C-3.7 µm)\*; Reference: Fluticasone Propionate Formulation 1 (A-4.5 µm); Natural log transformed AUC0-last: mixed models analysis with sequence, period, treatment as fixed effects and subject within sequence as a random effect.~All reported p-values are Bonferroni adjusted p-values."||122|106|0.0078
70872049|NCT02155608|141229483|SUPERIORITY|||||||0.54||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .38, df = 1/228.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||.54
71129632|NCT00711971|141764179|SUPERIORITY_OR_OTHER|||||||0.19|||||||ANOVA|||||||.19
71129633|NCT00711971|141764180|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71129634|NCT00711971|141764181|SUPERIORITY_OR_OTHER|||||||0.54|||||||ANOVA|||||||0.54
70858905|NCT01966692|141203877|EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of geometric means for Cmax fell completely within (80%, 125%).|ratio (%) of geometric means|182.0|||<|0.001|TWO_SIDED|90.0|159.0|208.0||The threshold for statistical significane was p=0.05.|Mixed Models Analysis||Mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Test: Fluticasone Propionate Formulation 2 (B-3.8 µm); Reference: Fluticasone Propionate Formulation 1 (A-4.5 µm); Natural log transformed Cmax: mixed models analysis with sequence, period, treatment as fixed effects and subject within sequence as a random effect.~All reported p-values are Bonferroni adjusted p-values."||208|159|<0.001
71129635|NCT02967510|141764182|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.304|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.304
71129636|NCT02967510|141764182|SUPERIORITY||Mean Difference (Final Values)|0.0|||=|0.109|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.109
70858906|NCT01966692|141203877|EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of geometric means for Cmax fell completely within (80%, 125%).|ratio (%) of geometric means|190.0|||<|0.001|TWO_SIDED|90.0|166.0|217.0||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||Mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Test: Fluticasone Propionate Formulation 3 (C-3.7 µm); Reference: Fluticasone Propionate Formulation 1 (A-4.5 µm); Natural log transformed Cmax: mixed models analysis with sequence, period, treatment as fixed effects and subject within sequence as a random effect.~All reported p-values are Bonferroni adjusted p-values."||217|166|<0.001
70858907|NCT01966692|141203877|EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of geometric means for Cmax fell completely within (80%, 125%).|ratio (%) of geometric means|213.0|||<|0.001|TWO_SIDED|90.0|186.0|244.0||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||Mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Test: Fluticasone Propionate Formulation 3 (C-3.7 µm)\*; Reference: Fluticasone Propionate Formulation 1 (A-4.5 µm); Natural log transformed Cmax: mixed models analysis with sequence, period, treatment as fixed effects and subject within sequence as a random effect.~All reported p-values are Bonferroni adjusted p-values."||244|186|<0.001
70858908|NCT02478398|141203885|SUPERIORITY||Mean Difference (Final Values)|-2.73|||<|0.001|TWO_SIDED|95.0|-3.45|-2.0|||ANOVA|Model included fixed effects of treatment, baseline asthma status, age group, pollen season, and pollen region nested within pollen season||||-2.00|-3.45|< 0.001
70858909|NCT02478398|141203886|SUPERIORITY||Difference in LS Mean|-1.86|||<|0.001|TWO_SIDED|95.0|-2.46|-1.27|||ANOVA|Model included fixed effects of treatment, baseline asthma status, age group, pollen season, and pollen region nested within pollen season||||-1.27|-2.46|< 0.001
70858910|NCT02478398|141203887|SUPERIORITY||Mean Difference (Final Values)|-1.4|||<|0.001|TWO_SIDED|95.0|-1.81|-0.99|||ANOVA|Model included fixed effects of treatment, baseline asthma status, age group, pollen season, and pollen region nested within pollen season||||-0.99|-1.81|< 0.001
70858911|NCT02478398|141203888|SUPERIORITY||Mean Difference (Final Values)|-1.84|||<|0.001|TWO_SIDED|95.0|-2.6|-1.08|||Zero-Inflated Log-Normal Model|Model included fixed effects of treatment, baseline asthma, age group, pollen season, and pollen region nested within pollen season||||-1.08|-2.60|< 0.001
70858912|NCT02478398|141203889|OTHER||Difference in % estimates|37.61|||<|0.001|TWO_SIDED|95.0|31.82|43.12|||Miettinen & Nurminen|||||43.12|31.82|< 0.001
70858913|NCT02478398|141203890|OTHER||Difference in % estimates|0.39|||=|0.32|TWO_SIDED|95.0|-0.57|1.53|||Miettinen & Nurminen|||||1.53|-0.57|= 0.320
70858914|NCT02478398|141203891|OTHER||Difference in % estimates|0.0|||=|0.996|TWO_SIDED|95.0|-0.92|0.92|||Miettinen & Nurminen|||||0.92|-0.92|= 0.996
70858915|NCT01362595|141203894|OTHER||||||||||||||||||Due to the small sample size, the statistical approach is primarily descriptive in nature.|||
70946883|NCT03672175|141393959|SUPERIORITY||Odds Ratio (OR)|0.9||||0.7307|TWO_SIDED|95.0|0.51|1.6||GEE for binary response model, with factors for treatment, BL sleep quality response, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 28||1.60|0.51|0.7307
70858916|NCT00737464|141203948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52|||||TWO_SIDED|||||||||||||
70858917|NCT01634178|141203983|OTHER|Food was considered to have no effect on the PK of apremilast if the 90% confidence interval (CI) of the geometric least squares (LS) mean ratios for AUC0-t and Cmax were completely contained within the range of 80% to 125%.|Ratio of Geometric Least Squares Means|98.3|||||TWO_SIDED|90.0|90.7|106.6|||||Ratio of the geometric LS means (Fed/Fasted), reported as percentages.|To assess the food effect, an analysis of variance model (ANOVA) with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax of apremilast.||106.6|90.7|
70858918|NCT01634178|141203985|OTHER||Median Difference|0.75||||0.0077|TWO_SIDED|90.0|0.25|1.25|||Wilcoxon signed-rank test||Median difference (Fed - Fasted) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||1.25|0.25|0.0077
70858919|NCT01634178|141203986|OTHER|Food was considered to have no effect on the PK of apremilast if the 90% CI of the geometric LS mean ratios for AUC0-t and Cmax were completely contained within the range of 80% to 125%.|Ratio of Geometric LS Means|112.4|||||TWO_SIDED|90.0|109.3|115.6|||||Ratio of the geometric LS means (Fed/Fasted), reported as percentages.|To assess the food effect, an analysis of variance model (ANOVA) with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t of apremilast.||115.6|109.3|
70858920|NCT01634178|141203987|OTHER||Ratio of Geometric Least Squares Means|112.0|||||TWO_SIDED|90.0|108.9|115.1|||||Ratio of the geometric LS means (Fed/Fasted), reported as percentages.|To assess the food effect, an ANOVA with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞ of apremilast.||115.1|108.9|
70858921|NCT02757950|141203992|OTHER|The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.|Incidence rate ratio|0.548||||0.1147|TWO_SIDED|95.0|0.259|1.157||A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.|Regression, Logistic|||The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.||1.157|0.259|0.1147
70946884|NCT03672175|141393959|SUPERIORITY||Odds Ratio (OR)|0.94||||0.8358|TWO_SIDED|95.0|0.52|1.7||GEE for binary response model, with factors for treatment, BL sleep quality response, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 28||1.70|0.52|0.8358
70946885|NCT03672175|141393960|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.72||0.7375|TWO_SIDED|95.0|-1.6|1.2||MMRM with treatment, BL SF-36v2 physical component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: PCS Score||1.2|-1.6|0.7375
70946886|NCT03672175|141393960|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.74||0.5144|TWO_SIDED|95.0|-1.9|1.0||MMRM with treatment, BL SF-36v2 physical component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: PCS Score||1.0|-1.9|0.5144
71129637|NCT02967510|141764182|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.119|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.119
71129638|NCT02967510|141764183|SUPERIORITY||LS Mean Difference|-0.74|||<|0.001|TWO_SIDED|95.0|-1.031|-0.444|||ANCOVA|||||-0.444|-1.031|<0.001
71129639|NCT02967510|141764183|SUPERIORITY||LS Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-1.051|-0.458|||ANCOVA|||||-0.458|-1.051|<0.001
71129640|NCT02967510|141764183|SUPERIORITY||LS Mean Difference|-0.66|||<|0.001|TWO_SIDED|95.0|-0.951|-0.369|||ANCOVA|||||-0.369|-0.951|<0.001
71129641|NCT02967510|141764184|SUPERIORITY||LS Mean Difference|0.21|||<|0.001|TWO_SIDED|95.0|0.147|0.278|||ANCOVA|||||0.278|0.147|<0.001
71129642|NCT02967510|141764184|SUPERIORITY||LS Mean Difference|0.15|||<|0.001|TWO_SIDED|95.0|0.078|0.213|||ANCOVA|||||0.213|0.078|<0.001
71129643|NCT02967510|141764184|SUPERIORITY||LS Mean Difference|0.16|||<|0.001|TWO_SIDED|95.0|0.097|0.226|||ANCOVA|||||0.226|0.097|<0.001
71129644|NCT02967510|141764185|SUPERIORITY||LS Mean Difference|-0.5|||<|0.001|TWO_SIDED|95.0|-0.603|-0.4|||ANCOVA|||||-0.4|-0.603|<0.001
71129645|NCT02967510|141764185|SUPERIORITY||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.572|-0.365|||ANCOVA|||||-0.365|-0.572|<0.001
71129646|NCT02967510|141764185|SUPERIORITY||LS Mean Difference|-0.43|||<|0.001|TWO_SIDED|95.0|-0.531|-0.331|||ANCOVA|||||-0.331|-0.531|<0.001
71129647|NCT02967510|141764186|SUPERIORITY||Mean Difference (Final Values)|0.0|||=|0.47|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.47
71129648|NCT02967510|141764186|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.448|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|0|-1|=0.448
71129649|NCT02967510|141764186|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.451|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.451
71129650|NCT02967510|141764187|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.329|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.329
70858922|NCT02757950|141203993|OTHER|The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.|Incidence rate ratio|0.428||||0.0155|TWO_SIDED|95.0|0.215|0.851||A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.|Regression, Logistic|||The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.||0.851|0.215|0.0155
70858923|NCT02757950|141203994|OTHER|The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.|Incidence rate ratio|0.254||||0.0127|TWO_SIDED|95.0|0.086|0.746||A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.|Regression, Logistic|||The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.||0.746|0.086|0.0127
70858924|NCT02757950|141203995|OTHER|The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.|Incidence rate ratio|0.638||||0.0036|TWO_SIDED|95.0|0.471|0.863||A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.|Regression, Logistic|||The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.||0.863|0.471|0.0036
70858925|NCT02757950|141203996|OTHER|The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.|Incidence rate ratio|1.342||||0.0931|TWO_SIDED|95.0|0.952|1.89||A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.|Regression, Logistic|||The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.||1.890|0.952|0.0931
70858926|NCT02313454|141204068|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_DEVIATION|0.8||0.008|TWO_SIDED|95.0|-1.0|-0.19|||Paired t-test||Intranasal Application relative to the Extranasal Application|||-0.19|-1.0|0.008
70858927|NCT02313454|141204069|SUPERIORITY||Mean Difference (Final Values)|-11.2|STANDARD_ERROR_OF_MEAN|15.7||0.004|TWO_SIDED|95.0|-19.0|-3.4|||Paired t-test||Intranasal application relative to Extranasal application|||-3.4|-19.0|0.004
70858928|NCT03170232|141204111|OTHER||Mean Difference (Final Values)|-67.2|STANDARD_ERROR_OF_MEAN|159.7||0.679|TWO_SIDED|95.0|-400.6|266.2|||Repeated measures random coefficient|||||266.2|-400.6|0.679
70858929|NCT01101191|141204148|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|103.0|||||TWO_SIDED|90.0|98.67|106.66|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||106.66|98.67|
70858930|NCT01101191|141204149|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|97.0|||||TWO_SIDED|90.0|94.2|99.81|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||99.81|94.20|
70858931|NCT01101191|141204150|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|97.1|||||TWO_SIDED|90.0|94.41|99.94|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||99.94|94.41|
70858932|NCT00718237|141204154|SUPERIORITY_OR_OTHER||Vaccine Efficacy (1-Relative Risk [RR])|80.2|||<|0.001|TWO_SIDED|95.0|47.4|94.1||Hypothesis: Efficacy \>0%. Based on p\< 1/(1+k); p = proportion of participants with outcome in vaccine group relative to total number of subjects with outcome; k = ratio of follow-up time; placebo/vaccine. Based on conditional binomial approach.|Exact Conditional Test|Exact Conditional Test based on Binomial Distribution|Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group, adjusted for the ratio of the follow-up period in each group.|||94.1|47.4|<0.001
70858933|NCT00718237|141204155|SUPERIORITY_OR_OTHER||Vaccine Efficacy (1-Relative Risk [RR])|74.5|||<|0.001|TWO_SIDED|95.0|39.9|90.6||Hypothesis: Efficacy \>0%. Based on p\< 1/(1+k); p = proportion of participants with outcome in vaccine group relative to total number of subjects with outcome; k = ratio of follow-up time; placebo/vaccine. Based on conditional binomial approach.|Exact Conditional Test|Exact Conditional Test based on Binomial Distribution|Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group, adjusted for the ratio of the follow-up period in each group.|||90.6|39.9|<0.001
70858934|NCT00718237|141204156|SUPERIORITY_OR_OTHER||Vaccine Efficacy (1-Relative Risk [RR])|100.0|||<|0.001|TWO_SIDED|95.0|55.4|100.0||Hypothesis: Efficacy \>0%. Based on p\< 1/(1+k); p = proportion of participants with outcome in vaccine group relative to total number of subjects with outcome; k = ratio of follow-up time; placebo/vaccine. Based on conditional binomial approach.|Exact Conditional Test|Exact Conditional Test based on Binomial Distribution|Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group, adjusted for the ratio of the follow-up period in each group.|||100.0|55.4|<0.001
70946887|NCT03672175|141393960|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.79||0.8343|TWO_SIDED|95.0|-1.7|1.4||MMRM with treatment, BL SF-36v2 physical component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: PCS Score||1.4|-1.7|0.8343
70858935|NCT02925793|141204164|SUPERIORITY||Mean Difference|-2.9||||0.0106|TWO_SIDED||||||SAS Proc Mixed||For each subject, change in NRS score from baseline to week 8 was calculated as Week 8 NRS value minus Baseline NRS value. Mean change in NRS score from baseline to week 8 for each group was then calculated using a Generalized Linear Mixed Model.|Both 1% and 5% groups (statistical analysis 2) produced the same estimated value (-2.9)||||0.0106
71129651|NCT02967510|141764187|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.348|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.348
71129652|NCT02967510|141764187|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.266|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.266
71129653|NCT02967510|141764188|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.122|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.122
71129654|NCT02967510|141764188|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.188|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.188
71129655|NCT02967510|141764188|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.222|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.222
71129656|NCT02967510|141764189|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.393|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.393
70946888|NCT03672175|141393960|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.85||0.4569|TWO_SIDED|95.0|-1.0|2.3||MMRM with treatment, BL SF-36v2 physical component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: PCS Score||2.3|-1.0|0.4569
71129657|NCT02967510|141764189|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.221|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.221
71129658|NCT02967510|141764189|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.432|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.432
70946889|NCT03672175|141393960|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.63||0.4663|TWO_SIDED|95.0|-2.0|4.4||MMRM with treatment, BL SF-36v2 mental component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: MCS Score||4.4|-2.0|0.4663
70946890|NCT03672175|141393960|SUPERIORITY||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|1.68||0.1138|TWO_SIDED|95.0|-0.6|6.0||MMRM with treatment, BL SF-36v2 mental component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: MCS Score||6.0|-0.6|0.1138
71129659|NCT02967510|141764190|SUPERIORITY||LS Mean Difference|0.24|||=|0.65|TWO_SIDED|95.0|-1.0|1.487|||ANCOVA|||||1.487|-1|=0.65
71129660|NCT02967510|141764190|SUPERIORITY||LS Mean Difference|-0.24|||=|0.361|TWO_SIDED|95.0|-1.568|1.09|||ANCOVA|||||1.09|-1.568|=0.361
71129661|NCT02967510|141764190|SUPERIORITY||LS Mean Difference|0.03|||=|0.522|TWO_SIDED|95.0|-1.188|1.257|||ANCOVA|||||1.257|-1.188|=0.522
71129662|NCT02967510|141764191|SUPERIORITY||LS Mean Difference|-0.56|||=|0.043|TWO_SIDED|95.0|-1.204|0.079|||ANCOVA|||||0.079|-1.204|=0.043
71129663|NCT02967510|141764191|SUPERIORITY||LS Mean Difference|-0.51|||=|0.061|TWO_SIDED|95.0|-1.158|0.137|||ANCOVA|||||0.137|-1.158|=0.061
71129664|NCT02967510|141764191|SUPERIORITY||LS Mean Difference|-0.48|||=|0.071|TWO_SIDED|95.0|-1.111|0.16|||ANCOVA|||||0.16|-1.111|=0.071
71129665|NCT02967510|141764192|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.012|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.012
71129666|NCT02967510|141764192|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.007|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.007
71129667|NCT02967510|141764192|SUPERIORITY||Median Difference (Final Values)|0.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|<0.001
71129668|NCT02967510|141764193|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.438|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.438
71129669|NCT02967510|141764193|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.388|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.388
71129670|NCT02967510|141764193|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.259|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.259
71129671|NCT02967510|141764194|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.022|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.022
71129672|NCT02967510|141764194|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.02|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.02
71129673|NCT02967510|141764194|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.003|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.003
71129674|NCT02967510|141764195|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.002|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.002
71129675|NCT02967510|141764195|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.331|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.331
71129676|NCT02967510|141764195|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.043|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.043
71129677|NCT02967510|141764196|SUPERIORITY||Median Difference (Final Values)|-1.0|||=|0.022|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.022
71129678|NCT02967510|141764196|SUPERIORITY||Median Difference (Final Values)|-1.0|||=|0.032|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.032
71129679|NCT02967510|141764196|SUPERIORITY||Median Difference (Final Values)|-1.0|||=|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.001
71129680|NCT02967510|141764197|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.176|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.176
71129681|NCT02967510|141764197|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.358|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.358
71129682|NCT02967510|141764197|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.21|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.21
70946891|NCT03672175|141393960|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.74||0.7901|TWO_SIDED|95.0|-3.0|3.9||MMRM with treatment, BL SF-36v2 mental component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: MCS Score||3.9|-3.0|0.7901
70858936|NCT02925793|141204164|SUPERIORITY||Mean Difference|-2.9||||0.0483|TWO_SIDED||||||SAS Proc Mixed||For each subject, change in NRS score from baseline to week 8 was calculated as Week 8 NRS value minus Baseline NRS value. Mean change in NRS score from baseline to week 8 for each group was then calculated using a Generalized Linear Mixed Model.|Both 1%(statistical analysis 1) and 5% groups produced the same estimated value (-2.9)||||0.0483
70858937|NCT05080660|141204226|SUPERIORITY||Posterior Mean Difference|0.23|||||TWO_SIDED|95.0|-0.26|0.73|||||Posterior mean difference with 95% credible interval is reported.|||0.73|-0.26|
70858938|NCT05080660|141204227|SUPERIORITY||Posterior Mean Difference|0.19|||||TWO_SIDED|95.0|-0.39|0.76|||||Posterior mean difference with 95% credible interval is reported.|||0.76|-0.39|
70858939|NCT05080660|141204228|SUPERIORITY||Posterior Mean Difference|0.62|||||TWO_SIDED|95.0|-0.23|1.47|||||Posterior mean difference with 95% credible interval is reported.|||1.47|-0.23|
70946892|NCT03672175|141393960|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.71||0.3955|TWO_SIDED|95.0|-1.9|4.8||MMRM with treatment, BL SF-36v2 mental component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: MCS Score||4.8|-1.9|0.3955
70946893|NCT03672175|141393961|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.83||0.8821|TWO_SIDED|95.0|-1.8|1.5||MMRM with treatment, BL PHQ-9 total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|MMRM|||Day 15||1.5|-1.8|0.8821
70858940|NCT05080660|141204229|SUPERIORITY||Posterior Mean Difference|0.34|||||TWO_SIDED|95.0|-0.67|1.34|||||Posterior mean difference with 95% credible interval is reported.|||1.34|-0.67|
70858941|NCT05080660|141204230|SUPERIORITY||Posterior Mean Difference|0.08|||||TWO_SIDED|95.0|-0.35|0.5|||||Posterior mean difference with 95% credible interval is reported.|||0.50|-0.35|
70858942|NCT05080660|141204231|SUPERIORITY||Posterior Mean Difference|0.1|||||TWO_SIDED|95.0|-0.35|0.55|||||Posterior mean difference with 95% credible interval is reported.|||0.55|-0.35|
70946894|NCT03672175|141393961|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.83||0.151|TWO_SIDED|95.0|-2.8|0.4||MMRM with treatment, BL PHQ-9 total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|MMRM|||Day 15||0.4|-2.8|0.1510
70858943|NCT05080660|141204232|SUPERIORITY||Posterior Mean Difference|1.98|||||TWO_SIDED|95.0|-0.88|4.88|||||Posterior mean difference with 95% credible interval is reported.|||4.88|-0.88|
70858944|NCT05080660|141204233|SUPERIORITY||Posterior Mean Difference|3.05|||||TWO_SIDED|95.0|-0.29|6.38|||||Posterior mean difference with 95% credible interval is reported.|||6.38|-0.29|
70858945|NCT05080660|141204234|SUPERIORITY||Posterior Mean Difference|0.13|||||TWO_SIDED|95.0|-0.23|0.5|||||Posterior mean difference with 95% credible interval is reported.|||0.50|-0.23|
70858946|NCT05080660|141204235|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.39|0.37|||||Posterior mean difference with 95% credible interval is reported.|||0.37|-0.39|
70858947|NCT05080660|141204236|SUPERIORITY||Posterior Mean Difference|0.3|||||TWO_SIDED|95.0|-0.21|0.81|||||Posterior mean difference with 95% credible interval is reported.|||0.81|-0.21|
70858948|NCT05080660|141204237|SUPERIORITY||Posterior Mean Difference|0.29|||||TWO_SIDED|95.0|-0.31|0.9|||||Posterior mean difference with 95% credible interval is reported.|||0.90|-0.31|
70858949|NCT05080660|141204238|SUPERIORITY||Posterior Mean Difference|6.14|||||TWO_SIDED|95.0|-0.24|12.52|||||Posterior mean difference with 95% credible interval is reported.|||12.52|-0.24|
70858950|NCT05080660|141204239|SUPERIORITY||Posterior Mean Difference|5.15|||||TWO_SIDED|95.0|-1.9|12.18|||||Posterior mean difference with 95% credible interval is reported.|||12.18|-1.90|
70858951|NCT05080660|141204240|SUPERIORITY||Posterior Mean Difference|-0.02|||||TWO_SIDED|95.0|-0.32|0.27|||||Posterior mean difference with 95% credible interval is reported.|||0.27|-0.32|
70858952|NCT05080660|141204241|SUPERIORITY||Posterior Mean Difference|-0.2|||||TWO_SIDED|95.0|-0.52|0.13|||||Posterior mean difference with 95% credible interval is reported.|||0.13|-0.52|
70946895|NCT03672175|141393961|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.84||0.2926|TWO_SIDED|95.0|-0.8|2.5||MMRM with treatment, BL PHQ-9 total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|MMRM|||Day 42||2.5|-0.8|0.2926
70858953|NCT05080660|141204242|SUPERIORITY||Posterior Mean Difference|98.35|||||TWO_SIDED|95.0|-51.95|250.88|||||Posterior mean difference with 95% credible interval is reported.|||250.88|-51.95|
70858954|NCT05080660|141204243|SUPERIORITY||Posterior Mean Difference|123.36|||||TWO_SIDED|95.0|-46.51|293.69|||||Posterior mean difference with 95% credible interval is reported.|||293.69|-46.51|
70858955|NCT05080660|141204244|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.06|0.05|||||Posterior mean difference with 95% credible interval is reported.|||0.05|-0.06|
70858956|NCT05080660|141204245|SUPERIORITY||Posterior Mean Difference|0.0|||||TWO_SIDED|95.0|-0.07|0.07|||||Posterior mean difference with 95% credible interval is reported.|||0.07|-0.07|
70858957|NCT04533685|141204246|SUPERIORITY||Adjusted Risk Ratio|1.01|||||TWO_SIDED|95.0|1.0|1.02|||||Adjusted risk ratio. These results compare arms which received reminder letters to the arm receiving no reminder letter (control)|Comparing the risk of receiving an influenza vaccination||1.02|1.00|
70858958|NCT04533685|141204246|SUPERIORITY||Adjusted Risk Ratio|1.0|||||TWO_SIDED|95.0|0.98|1.01|||||These results compare arms which received direct appointment scheduling to the arms not receiving direct appointment scheduling.|Comparing the risk of receiving an influenza vaccination||1.01|0.98|
70858959|NCT04533685|141204246|SUPERIORITY||Adjusted Risk Ratio|1.0|||||TWO_SIDED|95.0|1.0|1.01|||||These results compare arms which received pre-commitment reminders to the arms not receiving pre-commitment reminders.|Comparing the risk of receiving an influenza vaccination||1.01|1.00|
70858960|NCT04533685|141204246|SUPERIORITY||Adjusted Risk Ratio|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||These results compare arms which received pre-appointment reminder to the arms not receiving pre-appointment reminder.|Comparing the risk of receiving an influenza vaccination||1.01|0.99|
70946896|NCT03672175|141393961|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.83||0.4785|TWO_SIDED|95.0|-2.2|1.0||MMRM with treatment, BL PHQ-9 total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|MMRM|||Day 42||1.0|-2.2|0.4785
70858961|NCT04221230|141204247|OTHER||Least square mean difference|-1.7|STANDARD_ERROR_OF_MEAN|1.08||0.121|TWO_SIDED|95.0|-3.8|0.4|||Mixed Model Repeated Measures|||||0.4|-3.8|0.121
70858962|NCT02021656|141204276|SUPERIORITY||||||<|0.001|||||||Binomial Exact Test|||A sample size of 100 Chinese participants in the treatment naive group provided at least 90% power to detect a 17% improvement in SVR12 rate from the historical control rate of 57% using 2-sided exact one-sample binomial test at significant level of 0.05.||||<0.001
70858963|NCT03150485|141204303|SUPERIORITY|Superiority was established is the lower limit of the 95% confidence interval was above 50%.|Estimated Proportion|77.27|||||TWO_SIDED|95.0|56.15|90.29|||Agresti-Coull|||The Agresti-Coull method was used to estimate the confidence interval of the binomial proportions of subjects with less than 2 lens modifications.||90.29|56.15|
70858964|NCT00478881|141204339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.045||||0.5293||95.0|-33.194|17.104||Bladder volume (mL) at first detrusor contraction tested first. If significant, the change in the average number of daily micturitions was to be tested using a P\<0.05.|ANCOVA||Placebo-Vardenafil|Countries were pooled into 2 clusters, which allowed for testing of Treatment by Center interaction. An ANCOVA including Baseline (Visit 2) as a covariate with main effects for treatment and country (see pooling above) was used to test treatment difference for the primary variable and co-primary variable.||17.104|-33.194|0.5293
70858965|NCT00478881|141204340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.668||||0.0575||95.0|-0.021|1.358||Bladder volume (mL) at first detrusor contraction tested first. If significant, the change in the average number of daily micturitions was to be tested using a P \<0.05.|ANCOVA||Placebo - Vardenafil|Countries were pooled into 2 clusters, which allowed for testing of Treatment by Center interaction. An ANCOVA including Baseline (Visit 2) as a covariate with main effects for treatment and country (see pooling above) was used to test treatment difference for the primary variable and co-primary variable.||1.358|-0.021|0.0575
70858966|NCT00478881|141204341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.657||||0.8533||95.0|-6.335|7.65||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||Placebo- Vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||7.650|-6.335|0.8533
70858967|NCT00478881|141204342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.59||||0.1539||95.0|-37.057|5.876||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||Placebo- Vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||5.876|-37.057|0.1539
70858968|NCT00478881|141204343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.374||||0.2348||95.0|-32.834|8.087||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||placebo - vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||8.087|-32.834|0.2348
70858969|NCT00478881|141204344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.195||||0.3289||95.0|-24.692|8.303||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||placebo - vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||8.303|-24.692|0.3289
70858970|NCT00478881|141204345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.721||||0.0609||95.0|-0.033|1.476||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||placebo - vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||1.476|-0.033|0.0609
70858971|NCT00478881|141204346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118||||0.4928||95.0|-0.22|0.456||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||placebo - vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||0.456|-0.220|0.4928
70858972|NCT00478881|141204347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.823||||0.3248||95.0|-2.476|0.829||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||placebo - vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||0.829|-2.476|0.3248
70858973|NCT00478881|141204348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.095||||0.5312||95.0|-4.533|2.342||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA|||ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||2.342|-4.533|0.5312
70858974|NCT05128929|141204373|SUPERIORITY||Mean Difference (Final Values)|0.614||||0.541|TWO_SIDED|95.0|-1.47|2.79|||Mixed Models Analysis|Analysis was adjusted for the randomization stratum of PAH Group.||"Null: There is no significant difference in the mean primary endpoint (PVR) at 24 weeks between the treatment (H01) and placebo group.~The following analysis utilizes PVR determined by TD."||2.79|-1.47|0.541
70858975|NCT05128929|141204375|SUPERIORITY||Mean Difference (Final Values)|1.47||||0.599|TWO_SIDED|95.0|-4.34|7.27|||Mixed Models Analysis|Analysis was adjusted for the randomization stratum of PAH Group.||Null: There is no significant difference in the mean secondary endpoint (mPAP) at 24 weeks between the treatment (H01) and placebo group.||7.27|-4.34|0.599
70858976|NCT05128929|141204376|SUPERIORITY||Mean Difference (Final Values)|47.26||||0.166|TWO_SIDED|95.0|-21.43|115.95|||Mixed Models Analysis|Analysis was adjusted for the randomization stratum of PAH Group.||Null: There is no significant difference in the mean secondary endpoint (6MWT distance) at 24 weeks between the treatment (H01) and placebo group.||115.95|-21.43|0.166
70858977|NCT05128929|141204377|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.975|TWO_SIDED|95.0|-8.22|7.98|||Mixed Models Analysis|Analysis was adjusted for the randomization stratum of PAH Group.||Null: There is no significant difference in the mean secondary endpoint (emPHasis-10 score) at 24 weeks between the treatment (H01) and placebo group.||7.98|-8.22|0.975
70858978|NCT05128929|141204378|SUPERIORITY||Mean Difference (Final Values)|-9.0||||0.086|TWO_SIDED|95.0|-19.4|1.4|||Mixed Models Analysis|Analysis was adjusted for the randomization stratum of PAH Group.||Null: There is no significant difference in the mean secondary endpoint (SGRQ Score) at 24 weeks between the treatment (H01) and placebo group.||1.4|-19.40|0.086
70858979|NCT05128929|141204379|SUPERIORITY||Mean Difference (Final Values)|73.92||||0.215|TWO_SIDED|95.0|-45.61|193.46|||Mixed Models Analysis|Analysis was adjusted for the randomization stratum of PAH Group.||Null: There is no significant difference in the mean secondary endpoint (serum HA) at 24 weeks between the treatment (H01) and placebo group.||193.46|-45.61|0.215
70858980|NCT05128929|141204380|SUPERIORITY||Mean Difference (Final Values)|231.47||||0.442|TWO_SIDED|95.0|-377.26|840.2|||Mixed Models Analysis|||There is no significant difference in the mean secondary endpoint (NT-proBNP) at 24 weeks between the treatment (H01) and placebo group.||840.20|-377.26|0.442
70858981|NCT02742246|141204390|SUPERIORITY|||||||0.11||||||Group by Time interaction.|Regression, Linear|||||||0.11
70858982|NCT02742246|141204391|SUPERIORITY|||||||0.14||||||Group by time interaction.|Regression, Linear|||||||0.14
70858983|NCT02397564|141204392|SUPERIORITY_OR_OTHER|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||||||0.019
70858984|NCT03584373|141204394|NON_INFERIORITY|Non-inferiority margin of 1.3|Mean Difference (Net)|-0.14||||0.7|TWO_SIDED|95.0|-0.89|0.6|||t-test, 2 sided|||||0.60|-0.89|0.70
70858985|NCT03584373|141204395|NON_INFERIORITY|Non-inferiority margin of 1.3|Mean Difference (Net)|-0.23||||0.58|TWO_SIDED|95.0|-1.08|0.61|||t-test, 2 sided|||||0.61|-1.08|0.58
70858986|NCT03584373|141204396|NON_INFERIORITY|Non-inferiority margin of 1.3|Mean Difference (Net)|-1.91||||0.006|TWO_SIDED|95.0|-3.25|-0.56|||t-test, 2 sided|||||-0.56|-3.25|0.006
70858987|NCT03584373|141204397|NON_INFERIORITY|Non-inferiority margin of 1.3|Mean Difference (Net)|-1.16||||0.04|TWO_SIDED|95.0|-2.26|-0.06|||t-test, 2 sided|||||-0.06|-2.26|0.04
70858988|NCT03584373|141204398|NON_INFERIORITY|Non-inferiority margin of 1.3|Mean Difference (Net)|-0.55||||0.33|TWO_SIDED|95.0|-1.67|0.56|||t-test, 2 sided|||||0.56|-1.67|0.33
70858989|NCT03584373|141204399|NON_INFERIORITY|Non-inferiority margin of 1.3|Mean Difference (Net)|0.06||||0.47|TWO_SIDED|95.0|-0.1|0.21|||t-test, 2 sided|||||0.21|-0.10|0.47
70858990|NCT01155479|141204417|SUPERIORITY_OR_OTHER||Difference in Estimated Means|2.6||||0.0033|TWO_SIDED|95.0|0.86|4.3|||constrained longitudinal analysis|||Preladenant 2 mg (Part 1) vs Placebo (Part 1)||4.30|0.86|0.0033
70858991|NCT01155479|141204417|SUPERIORITY_OR_OTHER||Difference in Estimated Means|1.3||||0.1382|TWO_SIDED|95.0|-0.41|2.94|||constrained longitudinal analysis|||Preladenant 5 mg (Part 1) vs Placebo (Part 1)||2.94|-0.41|0.1382
70858992|NCT01155479|141204417|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.4||||0.6378|TWO_SIDED|95.0|-1.29|2.11|||constrained longitudinal analysis|||Preladenant 10 mg (Part 1) vs Placebo (Part 1)||2.11|-1.29|0.6378
70946897|NCT04974723|141393983|NON_INFERIORITY|Cox proportional hazard model was used to calculate the hazard ratio with teriparatide as reference. Noninferiority of abaloparatide to teriparatide was to be concluded if the upper bound of the 2-sided 95% CI of the HR between abaloparatide versus teriparatide was \<1.3.|Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.81|1.1||||||||1.10|0.81|
70858993|NCT01155479|141204417|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.3||||0.6923|TWO_SIDED|95.0|-1.35|2.03|||constrained longitudinal analysis|||Rasagiline (Part 1) vs Placebo (Part 1)||2.03|-1.35|0.6923
70858994|NCT01155479|141204418|SUPERIORITY_OR_OTHER||Difference vs Placebo (%)|-9.7||||0.0785|TWO_SIDED|95.0|-21.0|1.82||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline UPDRS2+3 as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|generalized linear mixed model|||Preladenant 2 mg (Part 1) vs Placebo (Part 1)||1.82|-21.0|0.0785
70858995|NCT01155479|141204418|SUPERIORITY_OR_OTHER||Difference vs Placebo (%)|-6.3||||0.2735|TWO_SIDED|95.0|-17.6|5.05||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline UPDRS2+3 as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|generalized linear mixed model|||Preladenant 5 mg (Part 1) vs Placebo (Part 1)||5.05|-17.6|0.2735
70858996|NCT01155479|141204418|SUPERIORITY_OR_OTHER||Difference vs Placebo (%)|-3.7||||0.4823|TWO_SIDED|95.0|-15.2|7.99||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline UPDRS2+3 as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|generalized linear mixed model|||Preladenant 10 mg (Part 1) vs Placebo (Part 1)||7.99|-15.2|0.4823
70858997|NCT01155479|141204418|SUPERIORITY_OR_OTHER||Difference vs Placebo (%)|-2.3||||0.6827|TWO_SIDED|95.0|-13.9|9.24||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline UPDRS2+3 as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|generalized linear mixed model|||Rasagiline (Part 1) vs Placebo (Part 1)||9.24|-13.9|0.6827
70858998|NCT01155479|141204419|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.7||||0.0235|TWO_SIDED|95.0|0.09|1.27|||constrained longitudinal analysis|||Preladenant 2 mg (Part 1) vs Placebo (Part 1)||1.27|0.09|0.0235
70858999|NCT01155479|141204419|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.5||||0.1093|TWO_SIDED|95.0|-0.11|1.04|||constrained longitudinal analysis|||Preladenant 5 mg (Part 1) vs Placebo (Part 1)||1.04|-0.11|0.1093
70859000|NCT01155479|141204419|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.2||||0.5756|TWO_SIDED|95.0|-0.42|0.75|||constrained longitudinal analysis|||Preladenant 10 mg (Part 1) vs Placebo (Part 1)||0.75|-0.42|0.5756
70859001|NCT01155479|141204419|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.1||||0.6657|TWO_SIDED|95.0|-0.45|0.7|||constrained longitudinal analysis|||Rasagiline (Part 1) vs Placebo (Part 1)||0.70|-0.45|0.6657
71129683|NCT02967510|141764198|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.106|TWO_SIDED|95.0|0.0|1.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||1|0|=0.106
70859002|NCT00998764|141204425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74||||0.324|TWO_SIDED|95.0|-0.74|2.23|||Mixed Models Analysis|||Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 13||2.23|-0.74|0.324
70859003|NCT00998764|141204425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.723|TWO_SIDED|95.0|-1.33|1.92|||Mixed Models Analysis|||Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 26||1.92|-1.33|0.723
70859004|NCT00998764|141204425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.966|TWO_SIDED|95.0|-1.81|1.89|||Mixed Models Analysis|||Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 39||1.89|-1.81|0.966
70859005|NCT00998764|141204425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.996|TWO_SIDED|95.0|-1.93|1.92|||Mixed Models Analysis|||Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 52||1.92|-1.93|0.996
70859006|NCT00998764|141204425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.336|TWO_SIDED|95.0|-3.67|1.26|||Mixed Models Analysis|||Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 78||1.26|-3.67|0.336
70859007|NCT00998764|141204426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.737|TWO_SIDED|95.0|-1.11|0.79|||Mixed Models Analysis|||Change from extension study baseline in ADAS-Cog at week 13||0.79|-1.11|0.737
70859008|NCT00998764|141204426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.213|TWO_SIDED|95.0|-1.76|0.4|||Mixed Models Analysis|||Change from extension study baseline in ADAS-Cog at week 26||0.40|-1.76|0.213
71129684|NCT02967510|141764198|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.229|TWO_SIDED|95.0|0.0|1.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||1|0|=0.229
70859009|NCT00998764|141204426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.168|TWO_SIDED|95.0|-2.19|0.38|||Mixed Models Analysis|||Change from extension study baseline in ADAS-Cog at week 39||0.38|-2.19|0.168
70859010|NCT00998764|141204426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91||||0.197|TWO_SIDED|95.0|-2.3|0.48|||Mixed Models Analysis|||Change from extension study baseline in ADAS-Cog at week 52||0.48|-2.30|0.197
70859011|NCT00998764|141204426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.13||||0.044|TWO_SIDED|95.0|-4.21|0.06|||Mixed Models Analysis|||Change from extension study baseline in ADAS-Cog at week 78||0.06|-4.21|0.044
70859012|NCT00998764|141204427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.99||||0.077|TWO_SIDED|95.0|-6.3|0.33|||Mixed Models Analysis|||Change from base study baseline in DAD score at Week 13||0.33|-6.30|0.077
70859013|NCT00998764|141204427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.67||||0.117|TWO_SIDED|95.0|-6.02|0.67|||Mixed Models Analysis|||Change from base study baseline in DAD score at Week 26||0.67|-6.02|0.117
71129685|NCT02967510|141764198|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.345|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.345
70859014|NCT00998764|141204427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.063|TWO_SIDED|95.0|-7.38|0.19|||Mixed Models Analysis|||Change from base study baseline in DAD score at Week 39||0.19|-7.38|0.063
71129686|NCT02967510|141764199|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.026|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.026
71129687|NCT02967510|141764199|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.424|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.424
71129688|NCT02967510|141764199|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.414|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.414
71129689|NCT02967510|141764200|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.36|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.36
71129690|NCT02967510|141764200|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.12|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.12
71129691|NCT02967510|141764200|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.266|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.266
71129692|NCT02967510|141764201|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.47|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.47
71129693|NCT02967510|141764201|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.137|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.137
71129694|NCT02967510|141764201|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.133|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.133
71129695|NCT02967510|141764202|SUPERIORITY||LS Mean Difference|0.74|||=|0.85|TWO_SIDED|95.0|-0.669|2.153|||ANCOVA|||||2.153|-0.669|=0.85
71129696|NCT02967510|141764202|SUPERIORITY||LS Mean Difference|0.87|||=|0.877|TWO_SIDED|95.0|-0.611|2.361|||ANCOVA|||||2.361|-0.611|=0.877
71129697|NCT02967510|141764202|SUPERIORITY||LS Mean Difference|-0.64|||=|0.178|TWO_SIDED|95.0|-2.009|0.728|||ANCOVA|||||0.728|-2.009|=0.178
71129698|NCT02967510|141764203|SUPERIORITY||LS Mean Difference|-0.16|||=|0.323|TWO_SIDED|95.0|-0.854|0.531|||ANCOVA|||||0.531|-0.854|=0.323
71129699|NCT02967510|141764203|SUPERIORITY||LS Mean Difference|-0.22|||=|0.272|TWO_SIDED|95.0|-0.917|0.484|||ANCOVA|||||0.484|-0.917|=0.272
71129700|NCT02967510|141764203|SUPERIORITY||LS Mean Difference|-0.6|||=|0.043|TWO_SIDED|95.0|-1.29|0.084|||ANCOVA|||||0.084|-1.29|=0.043
70946898|NCT04974723|141393984|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.89|1.3||||||Cox proportional hazard model was used to calculate the hazard ratio with teriparatide as reference. Noninferiority of abaloparatide to teriparatide was to be concluded if the upper bound of the 2-sided 95% CI of the HR between abaloparatide versus teriparatide was \<1.3.||1.30|0.89|
70946899|NCT04974723|141393985|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.95|1.22||||||Cox proportional hazard model was used to calculate the hazard ratio with teriparatide as reference. Noninferiority of abaloparatide to teriparatide was to be concluded if the upper bound of the 2-sided 95% CI of the HR between abaloparatide versus teriparatide was \<1.3.||1.22|0.95|
70946900|NCT01898442|141394039|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED||||||ANCOVA|||||||0.017
71129701|NCT02967510|141764204|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.009|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.009
71129702|NCT02967510|141764204|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.025|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.025
71129703|NCT02967510|141764204|SUPERIORITY||Median Difference (Final Values)|0.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|<0.001
71129704|NCT02967510|141764205|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.04|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.04
71129705|NCT02967510|141764205|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.259|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.259
71129706|NCT02967510|141764205|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.104|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.104
71129707|NCT02967510|141764206|SUPERIORITY||Median Difference (Final Values)|-1.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|<0.001
71129708|NCT02967510|141764206|SUPERIORITY||Median Difference (Final Values)|-1.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|<0.001
71129709|NCT02967510|141764206|SUPERIORITY||Median Difference (Final Values)|0.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|<0.001
71129710|NCT02967510|141764207|SUPERIORITY||Median Difference (Final Values)|0.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|<0.001
71129711|NCT02967510|141764207|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.054|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.054
71129712|NCT02967510|141764207|SUPERIORITY||Median Difference (Final Values)|0.0|||<|0.001|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|<0.001
71129713|NCT02967510|141764208|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.008|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.008
71129714|NCT02967510|141764208|SUPERIORITY||Median Difference (Final Values)|-1.0|||=|0.01|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.01
71129715|NCT02967510|141764208|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.001
71129716|NCT02967510|141764209|SUPERIORITY||LS Mean Difference|-0.81|||<|0.001|TWO_SIDED|95.0|-1.071|-0.548|||ANCOVA|||||-0.548|-1.071|<0.001
71129717|NCT02967510|141764209|SUPERIORITY||LS Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-1.013|-0.484|||ANCOVA|||||-0.484|-1.013|<0.001
71129718|NCT02967510|141764209|SUPERIORITY||LS Mean Difference|-0.66|||<|0.001|TWO_SIDED|95.0|-0.916|-0.397|||ANCOVA|||||-0.397|-0.916|<0.001
71129719|NCT02967510|141764210|SUPERIORITY||LS Mean Difference|0.44|||<|0.001|TWO_SIDED|95.0|0.337|0.535|||ANCOVA|||||0.535|0.337|<0.001
70859015|NCT00998764|141204427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75||||0.412|TWO_SIDED|95.0|-5.95|2.44|||Mixed Models Analysis|||Change from base study baseline in DAD score at Week 52||2.44|-5.95|0.412
70859016|NCT00998764|141204427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.78||||0.321|TWO_SIDED|95.0|-8.28|2.73|||Mixed Models Analysis|||Change from base study baseline in DAD score at Week 78||2.73|-8.28|0.321
71129720|NCT02967510|141764210|SUPERIORITY||LS Mean Difference|0.39|||<|0.001|TWO_SIDED|95.0|0.291|0.494|||ANCOVA|||||0.494|0.291|<0.001
71129721|NCT02967510|141764210|SUPERIORITY||LS Mean Difference|0.34|||<|0.001|TWO_SIDED|95.0|0.245|0.439|||ANCOVA|||||0.439|0.245|<0.001
71129722|NCT02967510|141764211|SUPERIORITY||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.575|-0.371|||ANCOVA|||||-0.371|-0.575|<0.001
71129723|NCT02967510|141764211|SUPERIORITY||LS Mean Difference|-0.49|||<|0.001|TWO_SIDED|95.0|-0.592|-0.383|||ANCOVA|||||-0.383|-0.592|<0.001
71129724|NCT02967510|141764211|SUPERIORITY||LS Mean Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-0.5|-0.3|||ANCOVA|||||-0.3|-0.5|<0.001
71129725|NCT00536471|141764212|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||Repeated Measures Analysis for Group A change from baseline to 8 week endpoint.|Mixed Models Analysis|Model=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit||||||0.051
71129726|NCT00536471|141764212|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Repeated Measures Analysis for Group B change from baseline to 8 week endpoint.|Mixed Models Analysis|Model=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit||||||<0.001
71129727|NCT00536471|141764213|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Total Score 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.013
71129728|NCT00536471|141764213|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Total Score 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||<0.001
71129729|NCT00536471|141764213|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||P-value for Maier 8 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.026
71129730|NCT00536471|141764213|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Maier 8 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||<0.001
71129731|NCT00536471|141764213|SUPERIORITY_OR_OTHER|||||||0.202||95.0||||P-value for Anxiety/Somatization 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.202
71129732|NCT00536471|141764213|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Anxiety/Somatization 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||<0.001
71129733|NCT00536471|141764213|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||P-value for Bech 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.027
71129734|NCT00536471|141764213|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Bech 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||<0.001
71129735|NCT00536471|141764213|SUPERIORITY_OR_OTHER|||||||0.076||95.0||||P-value for Retardation 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.076
71129736|NCT00536471|141764213|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Retardation 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||<0.001
71129737|NCT00536471|141764213|SUPERIORITY_OR_OTHER|||||||0.149||95.0||||P-value for Sleep 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.149
70859017|NCT00998764|141204428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.329|TWO_SIDED|95.0|-3.24|1.09|||Mixed Models Analysis|||Change from extension study baseline in DAD score at Week 13||1.09|-3.24|0.329
70859018|NCT00998764|141204428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.601|TWO_SIDED|95.0|-3.31|1.92|||Mixed Models Analysis|||Change from extension study baseline in DAD score at Week 26||1.92|-3.31|0.601
70859019|NCT00998764|141204428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55||||0.328|TWO_SIDED|95.0|-4.67|1.56|||Mixed Models Analysis|||Change from extension study baseline in DAD score at Week 39||1.56|-4.67|0.328
70859020|NCT00998764|141204428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71||||0.68|TWO_SIDED|95.0|-2.7|4.13|||Mixed Models Analysis|||Change from extension study baseline in DAD score at Week 52||4.13|-2.70|0.680
70859021|NCT00998764|141204428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.954|TWO_SIDED|95.0|-5.05|4.77|||Mixed Models Analysis|||Change from extension study baseline in DAD score at Week 78||4.77|-5.05|0.954
70859022|NCT00998764|141204429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.931|TWO_SIDED|95.0|-2.4|2.62|||Mixed Models Analysis|||Change from base study baseline in NPI score at week 26.||2.62|-2.40|0.931
70859023|NCT00998764|141204429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.524|TWO_SIDED|95.0|-3.26|1.67|||Mixed Models Analysis|||Change from base study baseline in NPI score at week 52.||1.67|-3.26|0.524
70859024|NCT00998764|141204429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.03||||0.353|TWO_SIDED|95.0|-6.32|2.27|||Mixed Models Analysis|||Change from base study baseline in NPI score at week 78.||2.27|-6.32|0.353
70859025|NCT00998764|141204430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.531|TWO_SIDED|95.0|-2.92|1.51|||Mixed Models Analysis|||Change from extension study baseline in NPI score at week 26.||1.51|-2.92|0.531
70859026|NCT00998764|141204430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.84||||0.137|TWO_SIDED|95.0|-4.28|0.59|||Mixed Models Analysis|||Change from extension study baseline in NPI score at week 52.||0.59|-4.28|0.137
70859027|NCT00998764|141204430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.32||||0.128|TWO_SIDED|95.0|-7.6|0.96|||Mixed Models Analysis|||Change from extension study baseline in NPI score at week 78.||0.96|-7.60|0.128
70859028|NCT00998764|141204431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.811|TWO_SIDED|95.0|-0.49|0.63|||Mixed Models Analysis|||Change from base study baseline in MMSE score at Week 6.||0.63|-0.49|0.811
70946901|NCT05178979|141394045|SUPERIORITY||Wald Chi-Square|1.94||||0.38|TWO_SIDED|||||Models control for clinic, gender, lifetime experience of intimate partner violence (IPV) and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.38
70859029|NCT00998764|141204431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.681|TWO_SIDED|95.0|-0.45|0.69|||Mixed Models Analysis|||Change from base study baseline in MMSE score at Week 19.||0.69|-0.45|0.681
70859030|NCT00998764|141204431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.742|TWO_SIDED|95.0|-0.51|0.72|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 32.||0.72|-0.51|0.742
70859031|NCT00998764|141204431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.598|TWO_SIDED|95.0|-0.48|0.83|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 45.||0.83|-0.48|0.598
70859032|NCT00998764|141204431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.922|TWO_SIDED|95.0|-0.85|0.77|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 78.||0.77|-0.85|0.922
70946902|NCT05178979|141394045|SUPERIORITY||unstandardized beta|0.93|STANDARD_ERROR_OF_MEAN|4.63||0.84|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up|Regression, Linear|Models control for clinic, gender, lifetime experience of intimate partner violence (IPV) and are adjusted for multiple time points.||Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.||||0.84
70859033|NCT00998764|141204432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.099|TWO_SIDED|95.0|-0.08|0.9|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 6.||0.90|-0.08|0.099
70859034|NCT00998764|141204432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.089|TWO_SIDED|95.0|-0.07|1.01|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 19.||1.01|-0.07|0.089
70859035|NCT00998764|141204432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.152|TWO_SIDED|95.0|-0.17|1.08|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 32.||1.08|-0.17|0.152
70859036|NCT00998764|141204432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.16|TWO_SIDED|95.0|-0.21|1.25|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 45.||1.25|-0.21|0.160
70859037|NCT00998764|141204432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.603|TWO_SIDED|95.0|-0.73|1.26|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 78.||1.26|-0.73|0.603
70859038|NCT04761627|141204433|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Geometric Least Squares (LS) Means Ratio|0.9325|||||TWO_SIDED|90.0|0.8874|0.9799|||||Switching group vs Continued-use group.|The ratio of geometric LS means, and 90% confidence intervals (CIs) were estimated using the analysis of covariance (ANCOVA) model adjusted for the actual stratification factors if prior biologic use for psoriasis, baseline body weight group, geographic region, and PK trough concentration at week 28.||0.9799|0.8874|
70859039|NCT04761627|141204434|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Geometric LS Means Ratio|0.9483|||||TWO_SIDED|90.0|0.8977|1.0018|||||Switching group vs Continued-use group.|The ratio of geometric LS means, and 90% CIs were estimated using the ANCOVA model adjusted for the actual stratification factors if prior biologic use for psoriasis, baseline body weight group, geographic region, and PK trough concentration at week 28.||1.0018|0.8977|
70859040|NCT04761627|141204436|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Geometric LS Means Ratio|0.9617|||||TWO_SIDED|90.0|0.8319|1.1119|||||Ctrough,ss at Week 28: Switching group vs Continued-use group|The ratio of Geometric LS means, and 90% CI for Ctrough,ss at week 28 were estimated based on an ANCOVA model adjusted for the actual stratification factors of prior biologic use for psoriasis, baseline body weight group, and geographic region.||1.1119|0.8319|
70859041|NCT04761627|141204436|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Geometric LS Means Ratio|0.9662|||||TWO_SIDED|90.0|0.8879|1.0515|||||Ctrough,ss at Week 40: Switching group vs Continued-use group|The ratio of geometric LS means, and 90% CI for Ctrough,ss at week 40 between the 2 treatment groups were estimated using an ANCOVA model adjusting for stratification factors and PK trough concentration at week 28.||1.0515|0.8879|
70859042|NCT04761627|141204436|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Geomtric LS Means Ratio|0.9806|||||TWO_SIDED|90.0|0.8916|1.0785|||||Ctrough,ss at Week 52: Switching group vs Continued-use group|The ratio of geometric LS means, and 90% CI for Ctrough,ss at week 52 between the 2 treatment groups were estimated using an ANCOVA model adjusting for stratification factors and PK trough concentration at week 28.||1.0785|0.8916|
70859043|NCT04761627|141204437|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Mean difference|0.07|||||TWO_SIDED|90.0|-2.62|2.77|||||Mean difference in PASI percent improvement from baseline at Week 64: Switching group - Continued-use group|Multiple imputation was applied for the point estimate and CI of the mean difference between the switching and continued-use groups. Missing PASI scores at the week 64 visit were imputed by MI.||2.77|-2.62|
70859044|NCT04761627|141204438|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Response difference|0.2|||||TWO_SIDED|90.0|-5.7|6.2|||||Response difference in PASI 75 Response at Week 64: Switching group - Continued-use group|Response difference was estimated by the Mantel-Haenszel estimate, and the 90% CIs were estimated by the stratified Newcombe confidence limits, adjusting for the prior biologic use of psoriasis, baseline body weight group, geographic region. Missing post-baseline binary response data were imputed by NRI.||6.2|-5.7|
70859045|NCT04761627|141204439|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Response difference|0.2|||||TWO_SIDED|90.0|-7.4|7.8|||||Response difference in PASI 100 Response at Week 64: Switching group - Continued-use group|Response difference was estimated by the Mantel-Haenszel estimate, and the 90% CIs were estimated by the stratified Newcombe confidence limits, adjusting for the prior biologic use of psoriasis, baseline body weight group, geographic region. Missing post-baseline binary response data were imputed by NRI.||7.8|-7.4|
70859046|NCT04761627|141204441|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Risk Difference (RD)|-0.48|||||TWO_SIDED|90.0|-4.17|3.1|||||Switching group - continued-use group|Risk difference for any EOI: risk difference and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.||3.10|-4.17|
70859047|NCT01255787|141204494|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|1.123||0.907|TWO_SIDED|95.0|-3.258|2.035||Adjustment for multiplicity for the comparisons was based on the Dunnett-Hsu procedure.|ANCOVA|Analysis of covariance (ANCOVA), with treatment as a fixed factors and baseline MADRS as a covariate.||All statistical tests were 2-sided with the estimated P-values at the 5% level of significance.||2.035|-3.258|0.9070
70859048|NCT01255787|141204494|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.69|STANDARD_ERROR_OF_MEAN|1.114||0.3006|TWO_SIDED|95.0|-4.31|0.938|||ANCOVA|Analysis of covariance (ANCOVA), with treatment as a fixed factors and baseline MADRS as a covariate.||||0.938|-4.310|0.3006
70859049|NCT01255787|141204494|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.82|STANDARD_ERROR_OF_MEAN|1.11||0.2399|TWO_SIDED|95.0|-4.436|0.794|||ANCOVA|Analysis of covariance (ANCOVA), with treatment as a fixed factors and baseline MADRS as a covariate.||||0.794|-4.436|0.2399
70859050|NCT02398227|141204509|SUPERIORITY|||||||0.968|||||||ANCOVA|p value reported for overall effect across all-time points between treatment arms||||||.968
70859051|NCT02398227|141204510|SUPERIORITY|||||||0.56|||||||ANCOVA|p value reported for overall effect across all-time points between treatment arms||||||.560
70859052|NCT00829985|141204525|SUPERIORITY_OR_OTHER||Risk Ratio, log|1.92|||<|0.0001|TWO_SIDED|95.0|1.51|2.45|||Mixed Models Analysis||The estimated value and associated confidence interval represent the ratio of baseline-to-post-baseline change in the placebo group (denominator = 1.12) vs. the extract group (numerator = 2.16).|||2.45|1.51|<0.0001
70859053|NCT00829985|141204526|SUPERIORITY_OR_OTHER||Risk Ratio, log|1.13||||0.088|TWO_SIDED|95.0|0.98|1.32|||Mixed Models Analysis||The estimated value and associated confidence interval represent the ratio of baseline-to-post-baseline change in the placebo group (denominator = 0.93) vs. the extract group (numerator = 1.06).|||1.32|0.98|0.088
70859054|NCT00829985|141204527|SUPERIORITY_OR_OTHER||Treatment Effect|0.37||||0.37|TWO_SIDED|95.0|-4.89|12.99|||Mixed Models Analysis||Estimated value and associated confidence interval represent the treatment effect: change in the extract group (4.7) minus change in the placebo group (0.7).|||12.99|-4.89|0.37
70859055|NCT00829985|141204528|SUPERIORITY_OR_OTHER||Treatment Effect|5.4||||0.09|TWO_SIDED|95.0|-0.77|11.51|||Mixed Models Analysis||Estimated value and associated confidence interval represent the treatment effect: change in the extract group (4.0) minus change in the placebo group (-1.3).|||11.51|-0.77|0.09
70859056|NCT03324581|141204536|SUPERIORITY||Difference|0.81|||=|0.7554|TWO_SIDED|95.0|-4.3|5.92||The change from baseline in CAARS-O:SV was analyzed using a Mixed-effect Model Repeated Measures (MMRM) methodology with the unstructured variance covariance matrix.|Mixed-effect Model Repeated Measures|It included fixed class-effect terms: treatment,trial site,visit week, interaction term: treatment by visit week, Baseline CAARS-O:SV as a covariate.||||5.92|-4.30|=0.7554
70859057|NCT03324581|141204536|SUPERIORITY||Difference|-6.61|||=|0.0101|TWO_SIDED|95.0|-11.6|-1.6||The change from baseline in CAARS-O:SV was analyzed using a MMRM methodology with the unstructured variance covariance matrix.|Mixed-effect Model Repeated Measures|It included fixed class-effect terms: treatment,trial site,visit week, interaction term: treatment by visit week, Baseline CAARS-O:SV as a covariate.||||-1.60|-11.6|=0.0101
70859058|NCT03324581|141204536|SUPERIORITY||Difference|-7.42|||=|0.0033|TWO_SIDED|95.0|-12.3|-2.5||The change from baseline in CAARS-O:SV was analyzed using a MMRM methodology with the unstructured variance covariance matrix.|Mixed-effect Model Repeated Measures|It included fixed class-effect terms: treatment,trial site,visit week, interaction term: treatment by visit week, Baseline CAARS-O:SV as a covariate.||||-2.50|-12.3|=0.0033
70859059|NCT04473482|141204577|SUPERIORITY|Generalized estimating equations with robust sandwich estimators used with Wald 95% confidence intervals and conversion to odds ratios|Odds Ratio (OR)|2.25|||||TWO_SIDED|95.0|||||||Generalized estimating equations with robust sandwich estimators used with Wald 95% confidence intervals and conversion to odds ratios||Generalized estimating equations with robust sandwich estimators used with Wald 95% confidence intervals|||
70859060|NCT04473482|141204578|SUPERIORITY||Odds Ratio (OR)|2.31|||||TWO_SIDED|95.0|||||||GEEs with robust sandwich estimators and Wald 95% CIs with conversion to Odds Ratios|||||
71129738|NCT00536471|141764213|SUPERIORITY_OR_OTHER|||||||0.062||95.0||||P-value for Sleep 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.062
71129739|NCT00536471|141764213|SUPERIORITY_OR_OTHER|||||||0.629||95.0||||P-value for Total Score 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.629
71129740|NCT00536471|141764213|SUPERIORITY_OR_OTHER|||||||0.194||95.0||||P-value for Total Score 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.194
71129741|NCT00536471|141764213|SUPERIORITY_OR_OTHER|||||||0.525||95.0||||P-value for Maier 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.525
71129742|NCT00536471|141764213|SUPERIORITY_OR_OTHER|||||||0.595||95.0||||P-value for Maier 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.595
71129743|NCT00536471|141764213|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||P-value for Anxiety/Somatization 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.736
71129744|NCT00536471|141764213|SUPERIORITY_OR_OTHER|||||||0.368||95.0||||P-value for Anxiety/Somatization 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.368
71129745|NCT00536471|141764213|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||P-value for Bech 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.660
71129746|NCT00536471|141764213|SUPERIORITY_OR_OTHER|||||||0.334||95.0||||P-value for Bech 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.334
71129747|NCT00536471|141764213|SUPERIORITY_OR_OTHER|||||||0.568||95.0||||P-value for Retardation 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.568
71129748|NCT00536471|141764213|SUPERIORITY_OR_OTHER|||||||0.216||95.0||||P-value for Retardation 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.216
71129749|NCT00536471|141764213|SUPERIORITY_OR_OTHER|||||||0.646||95.0||||P-value for Sleep 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.646
71129750|NCT00536471|141764213|SUPERIORITY_OR_OTHER|||||||0.275||95.0||||P-value for Sleep 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.275
71129751|NCT00536471|141764214|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.011
71129752|NCT00536471|141764214|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline)|Mixed Models Analysis|||||||<0.001
71129753|NCT00536471|141764214|SUPERIORITY_OR_OTHER|||||||0.449||95.0||||P-value for 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.449
71129754|NCT00536471|141764214|SUPERIORITY_OR_OTHER|||||||0.167||95.0||||P-value for 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.167
71129755|NCT00536471|141764215|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.016
71129756|NCT00536471|141764215|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||<0.001
71129757|NCT00536471|141764215|SUPERIORITY_OR_OTHER|||||||0.653||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.653
71129758|NCT00536471|141764215|SUPERIORITY_OR_OTHER|||||||0.417||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.417
71129759|NCT00536471|141764216|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change(Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.204
71129760|NCT00536471|141764216|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.011
71129761|NCT00536471|141764216|SUPERIORITY_OR_OTHER|||||||0.571||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.571
71129762|NCT00536471|141764216|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.133
70859061|NCT01306877|141204584|NON_INFERIORITY_OR_EQUIVALENCE|The objective is to reject H0 at the 0.05 significance level. A one-sided 95% confidence upper limit for PC - PE will be constructed by Newcombe's generalized Wilson score method (Newcombe 1998). H0 will be rejected at the 0.05 significance level if this upper limit is \<7%.|Risk Difference (RD)|-0.314||||0.0001|ONE_SIDED|95.0||-0.18||P-value calculated from per protocol analysis set|Chi-squared|||||-0.18||0.0001
70859062|NCT01306877|141204588|SUPERIORITY_OR_OTHER|||||||0.1844|||||||Wilcoxon (Mann-Whitney)|||||||0.1844
70859063|NCT01306877|141204589|SUPERIORITY_OR_OTHER|||||||0.5647|||||||Wilcoxon (Mann-Whitney)|||||||0.5647
70859064|NCT01306877|141204590|SUPERIORITY_OR_OTHER|||||||0.9062|||||||Wilcoxon (Mann-Whitney)|||||||0.9062
70859065|NCT02376283|141204607|OTHER|A p value \< 0.05 was considered to be statistically significant.Comparison of means between groups assessed using ANOVA allowing comparison of more than 2 means and enabled assessment made of the relationship between different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||<|0.05||||||Assessment made of relationship between groups-clop vs pras vs tic,rows of STEMI vs NSTEMI/UA and different time points.P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.|ANOVA|||Continuous variables expressed as mean ± SD (standard deviation) and categorical variables as frequencies (%).Continuous variables analysed individually using student's independent sample t-tests. Categorical variables assessed using separate Fisher's exact (Chi-square) test.||||<0.05
70859066|NCT02376283|141204607|OTHER|Comparison of means between groups assessed using ANOVA allowing comparison of more than 2 means and enabled assessment made of the relationship between different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||<|0.0001|||||||ANOVA|ANOVA F(3,36) = 12.282||STEMI- clop vs prasl vs tic||||< 0.0001
70859067|NCT02376283|141204607|OTHER|Comparison of means between groups assessed using ANOVA allowing comparison of more than 2 means and enabled assessment made of the relationship between different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||<|0.0001||||||Assessment made of relationship between groups-clop vs pras vs tic,rows of STEMI vs NSTEMI/UA and different time points.P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.|ANOVA|ANOVA F(2,40) = 29.097||NSTEMI- clopidogrel vs prasugrel vs ticagrelor||||< 0.0001
70859068|NCT02376283|141204608|OTHER|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel active metabolite vs prasugrel active metabolite vs ticagrelor parent compound and active metabolite), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||<|0.05||||||Assessment made of relationship between groups-clop vs pras vs tic, rows of STEMI vs NSTEMI/UA and different time points. P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.|ANOVA|||"Continuous variables were expressed as mean ± SEM (Standard Error of Measurement) and categorical variables as frequencies (%).~Continuous variables were analysed individually using student's independent sample t-tests. Categorical variables were assessed using separate Fisher's exact (Chi-square) test."||||<0.05
70859069|NCT02376283|141204608|OTHER|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel active metabolite vs prasugrel active metabolite vs ticagrelor parent compound and active metabolite), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||=|0.123|||||||ANOVA|ANOVA F(6,56)=1.707||STEMI- different drugs (as stated above)||||=0.123
70859070|NCT02376283|141204608|OTHER|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel active metabolite vs prasugrel active metabolite vs ticagrelor parent compound and active metabolite), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||<|0.0001||||||Assessment made of relationship between groups-clop vs pras vs tic, rows of STEMI vs NSTEMI/UA and different time points. P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.|ANOVA|ANOVA F(4,62)=18.932||NSTEMI- different drugs (as stated above)||||<0.0001
70859071|NCT02376283|141204609|OTHER|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA) and different time points.|||||<|0.05||||||Assessment made of relationship between groups-clop vs pras vs tic, rows of STEMI vs NSTEMI/UA and different time points. P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.|ANOVA|||"Continuous variables were expressed as mean ± SD and categorical variables as frequencies (%).~Continuous variables were analysed individually using student's independent sample t-tests. Categorical variables were assessed using separate Fisher's exact (Chi-square) test."||||<0.05
71129763|NCT00536471|141764217|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.023
70946903|NCT05178979|141394045|SUPERIORITY||unstandardized beta|-2.62|STANDARD_ERROR_OF_MEAN|3.87||0.5|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up|Regression, Linear|Models control for clinic, gender, lifetime experience of intimate partner violence (IPV) and are adjusted for multiple time points.||Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.||||0.50
71129764|NCT00536471|141764217|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.100
71129765|NCT00536471|141764217|SUPERIORITY_OR_OTHER|||||||0.571||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.571
71129766|NCT00536471|141764217|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.133
71129767|NCT00536471|141764218|SUPERIORITY_OR_OTHER|||||||0.332||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.332
71129768|NCT00536471|141764218|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.041
71129769|NCT00536471|141764218|SUPERIORITY_OR_OTHER|||||||0.775||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.775
71129770|NCT00536471|141764218|SUPERIORITY_OR_OTHER|||||||0.588||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.588
71129771|NCT00536471|141764219|SUPERIORITY_OR_OTHER|||||||0.624||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.624
71129772|NCT00536471|141764219|SUPERIORITY_OR_OTHER|||||||0.473||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.473
71129773|NCT00536471|141764219|SUPERIORITY_OR_OTHER|||||||0.787||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.787
71129774|NCT00536471|141764219|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.086
71129775|NCT00536471|141764220|SUPERIORITY_OR_OTHER|||||||0.099||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.099
71129776|NCT00536471|141764220|SUPERIORITY_OR_OTHER|||||||0.223||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.223
71129777|NCT00536471|141764220|SUPERIORITY_OR_OTHER|||||||0.473||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.473
71129778|NCT00536471|141764220|SUPERIORITY_OR_OTHER|||||||0.233||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.233
71129779|NCT00536471|141764221|SUPERIORITY_OR_OTHER|||||||0.577||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.577
71129780|NCT00536471|141764221|SUPERIORITY_OR_OTHER|||||||0.567||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.567
71129781|NCT00536471|141764222|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.670
71129782|NCT00536471|141764222|SUPERIORITY_OR_OTHER|||||||0.059||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.059
71129783|NCT00536471|141764222|SUPERIORITY_OR_OTHER|||||||0.93||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.930
71129784|NCT00536471|141764222|SUPERIORITY_OR_OTHER|||||||0.567||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.567
71129785|NCT00536471|141764223|SUPERIORITY_OR_OTHER|||||||0.896||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.896
71129786|NCT00536471|141764223|SUPERIORITY_OR_OTHER|||||||0.796||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.796
71129787|NCT00536471|141764223|SUPERIORITY_OR_OTHER|||||||0.571||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.571
71129788|NCT00536471|141764223|SUPERIORITY_OR_OTHER|||||||0.381||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.381
71129789|NCT00536471|141764224|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.038
71129790|NCT00536471|141764224|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.002
71129791|NCT00536471|141764224|SUPERIORITY_OR_OTHER|||||||0.665||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.665
70859072|NCT02376283|141204609|OTHER|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA) and different time points.|||||=|0.81||||||STEMI- clopidogrel vs prasugrel vs ticagrelor|ANOVA|ANOVA F(3,17) = 0.321||"Continuous variables were expressed as mean ± SD and categorical variables as frequencies (%).~Continuous variables were analysed individually using student's independent sample t-tests. Categorical variables were assessed using separate Fisher's exact (Chi-square) test."||||=0.810
70859073|NCT02376283|141204609|OTHER|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA) and different time points.|||||<|0.0001||||||NSTEMI- clopi vs pras vs tic|ANOVA|ANOVA F(2,25) = 14.103||"Continuous variables were expressed as mean ± SD and categorical variables as frequencies (%).~Continuous variables were analysed individually using student's independent sample t-tests. Categorical variables were assessed using separate Fisher's exact (Chi-square) test."||||< 0.0001
70859074|NCT01076075|141204618|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.68|||<|0.001|TWO_SIDED|95.0|-0.87|-0.5|||ANCOVA|Based on an ANCOVA model controlling for treatment, stratum (type of sulfonylurea) and baseline value.||Pairwise comparison - Sitagliptin vs. Placebo, using the difference in the Least Squares Means.||-0.50|-0.87|<0.001
70859075|NCT01076075|141204619|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-33.5|||<|0.001|TWO_SIDED|95.0|-45.3|-21.7|||ANCOVA|Based on an ANCOVA model controlling for treatment, stratum (type of sulfonylurea) and baseline value.||Pairwise comparison - Sitagliptin vs. Placebo, difference in the Least Squares Means.||-21.7|-45.3|<0.001
70859076|NCT01076075|141204620|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-18.6|||<|0.001|TWO_SIDED|95.0|-26.4|-10.7|||ANCOVA|Based on an ANCOVA model controlling for treatment, stratum (type of sulfonylurea) and baseline value.||Pairwise comparison - Sitagliptin vs. Placebo, using the difference in the Least Squares Means.||-10.7|-26.4|<0.001
70859077|NCT03687970|141204641|OTHER|Multivariable logistic regression was applied to predict binary outcome while controlling for other potential confounding factors (age, cumulative chemotherapy dose, chemotherapy group).|Slope|-0.13||||0.05|TWO_SIDED|||||threshold for p value is 0.05.|Regression, Logistic|||||||0.05
70859078|NCT03687970|141204642|OTHER|Spearman correlation coefficient between the Aδ:C fiber detection threshold ratio and the severity of painful CIPN on NPSI scale for patients with painful CIPN was calculated.|rho coefficient|0.22||||0.7525|TWO_SIDED|||||The thrshold for p value is 0.05.|Spearman's correlation coefficient|||||||0.7525
70859079|NCT03687970|141204642|OTHER|Spearman correlation coefficient between the Aδ:C fiber detection threshold ratio and the severity of painful CIPN on NPSI scale for Control group patients without painful CIPN was calculated.|rho coefficient|0.32||||0.1876|TWO_SIDED|||||The threshold for p value is 0.05.|Spearman's correlation coefficien|||||||0.1876
70859080|NCT03687970|141204642|OTHER|Spearman correlation coefficient between the Aδ:C fiber pain threshold ratio and the severity of painful CIPN on NPSI scale for patients with painful CIPN was calculated.|rho coefficient|0.13||||0.61|TWO_SIDED|||||The threshold for p value is 0.05.|Spearman's correlation coefficient|||||||0.61
71129792|NCT00536471|141764224|SUPERIORITY_OR_OTHER|||||||0.253||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.253
71129793|NCT00536471|141764225|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.723
70859081|NCT03687970|141204642|OTHER|Spearman correlation coefficient between the Aδ:C fiber detection threshold ratio and the severity of painful CIPN on NPSI scale for patients with painful CIPN was calculated.|rho coefficient|-0.2812205||||0.2914|TWO_SIDED|||||The threshold for p value is 0.05.|Spearman's correlation coefficient|||||||0.2914
70859082|NCT02101112|141204682|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|1.054|||||TWO_SIDED|90.0|0.994|1.118||||||Apixaban, 10 mg (crushed and suspended in water) vs. Apixaban, 10 mg (whole tablets)||1.118|0.994|
70859083|NCT02101112|141204682|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.788|||||TWO_SIDED|90.0|0.741|0.839||||||Apixaban, 10 mg (crushed and mixed with applesauce) vs. Apixaban, 10 mg (whole tablets)||0.839|0.741|
70859084|NCT02101112|141204683|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|1.027|||||TWO_SIDED|90.0|0.981|1.076||||||Apixaban, 10 mg (crushed and suspended in water) vs. Apixaban, 10 mg (whole tablets)||1.076|0.981|
70859085|NCT02101112|141204683|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.835|||||TWO_SIDED|90.0|0.797|0.875||||||Apixaban, 10 mg (crushed and mixed with applesauce) vs. Apixaban, 10 mg (whole tablets)||0.875|0.797|
71129794|NCT00536471|141764225|SUPERIORITY_OR_OTHER|||||||0.312||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.312
71129795|NCT00536471|141764225|SUPERIORITY_OR_OTHER|||||||0.853||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.853
70859086|NCT02101112|141204684|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|1.027|||||TWO_SIDED|90.0|0.981|1.075||||||Apixaban, 10 mg (crushed and suspended in water) vs. Apixaban, 10 mg (whole tablets)||1.075|0.981|
70859087|NCT02101112|141204684|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.832|||||TWO_SIDED|90.0|0.794|0.871||||||Apixaban, 10 mg (crushed and mixed with applesauce) vs. Apixaban, 10 mg (whole tablets)||0.871|0.794|
70946904|NCT05178979|141394046|SUPERIORITY||Wald Chi-square|2.0||||0.37|TWO_SIDED|||||Models control for clinic and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.37
70946905|NCT05178979|141394046|SUPERIORITY||unstandardized beta|-0.02|STANDARD_ERROR_OF_MEAN|0.01||0.18|TWO_SIDED|||||P-value is adjusted for clinic; this value is the 6-month follow-up|Regression, Linear|Model controls for clinic||Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.||||0.18
71129796|NCT00536471|141764225|SUPERIORITY_OR_OTHER|||||||0.913||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.913
71129797|NCT00536471|141764226|SUPERIORITY_OR_OTHER|||||||0.234||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.234
71129798|NCT00536471|141764226|SUPERIORITY_OR_OTHER|||||||0.216||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.216
71129799|NCT00536471|141764226|SUPERIORITY_OR_OTHER|||||||0.853||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.853
71129800|NCT00536471|141764226|SUPERIORITY_OR_OTHER|||||||0.908||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.908
71129801|NCT00536471|141764227|SUPERIORITY_OR_OTHER|||||||0.789||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.789
71129802|NCT00536471|141764227|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.012
71129803|NCT00536471|141764227|SUPERIORITY_OR_OTHER|||||||0.414||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.414
71129804|NCT00536471|141764227|SUPERIORITY_OR_OTHER|||||||0.717||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.717
71129805|NCT00536471|141764228|SUPERIORITY_OR_OTHER|||||||0.78||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.780
71129806|NCT00536471|141764228|SUPERIORITY_OR_OTHER|||||||0.152||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.152
71129807|NCT00536471|141764228|SUPERIORITY_OR_OTHER|||||||0.637||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.637
71129808|NCT00536471|141764228|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.024
71129809|NCT00536471|141764229|SUPERIORITY_OR_OTHER|||||||0.517||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.517
71129810|NCT00536471|141764229|SUPERIORITY_OR_OTHER|||||||0.256||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.256
71129811|NCT00536471|141764229|SUPERIORITY_OR_OTHER|||||||1||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||1.000
71129812|NCT00536471|141764229|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.268
71129813|NCT00536471|141764230|SUPERIORITY_OR_OTHER|||||||0.741||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.741
71129814|NCT00536471|141764230|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.722
71129815|NCT00536471|141764230|SUPERIORITY_OR_OTHER|||||||1||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||1.000
71129816|NCT00536471|141764230|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.268
71129817|NCT00536471|141764231|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.723
71129818|NCT00536471|141764231|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.949
70946906|NCT05178979|141394046|SUPERIORITY||unstandardized beta|-0.03|STANDARD_ERROR_OF_MEAN|0.02||0.19|TWO_SIDED|||||P-value is adjusted for clinic; this value is the 12-month follow-up|Regression, Linear|Model controls for clinic|Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.||||0.19
71129819|NCT00536471|141764231|SUPERIORITY_OR_OTHER|||||||1||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||1.000
71129820|NCT00536471|141764231|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.268
71129821|NCT00536471|141764232|SUPERIORITY_OR_OTHER|||||||0.682||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.682
71129822|NCT00536471|141764232|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.001
71129823|NCT00536471|141764232|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.200
71129824|NCT00536471|141764232|SUPERIORITY_OR_OTHER|||||||0.813||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.813
71129825|NCT00536471|141764233|SUPERIORITY_OR_OTHER|||||||0.438||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.438
71129826|NCT00536471|141764233|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.018
71129827|NCT00536471|141764233|SUPERIORITY_OR_OTHER|||||||0.692||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.692
71129828|NCT00536471|141764233|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.668
71129829|NCT00536471|141764234|SUPERIORITY_OR_OTHER|||||||0.588||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.588
71129830|NCT00536471|141764234|SUPERIORITY_OR_OTHER|||||||0.758||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.758
71129831|NCT00536471|141764234|SUPERIORITY_OR_OTHER|||||||0.692||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.692
71129832|NCT00536471|141764234|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.668
71129833|NCT00536471|141764235|SUPERIORITY_OR_OTHER|||||||0.507||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.507
71129834|NCT00536471|141764235|SUPERIORITY_OR_OTHER|||||||0.466||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.466
71129835|NCT00536471|141764235|SUPERIORITY_OR_OTHER|||||||0.692||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.692
71129836|NCT00536471|141764235|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.668
71129837|NCT00536471|141764236|SUPERIORITY_OR_OTHER|||||||0.487||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.487
71129838|NCT00536471|141764236|SUPERIORITY_OR_OTHER|||||||0.678||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.678
71129839|NCT00536471|141764236|SUPERIORITY_OR_OTHER|||||||0.692||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.692
71129840|NCT00536471|141764236|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.668
71129841|NCT00536471|141764237|SUPERIORITY_OR_OTHER|||||||0.505||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.505
71129842|NCT00536471|141764237|SUPERIORITY_OR_OTHER|||||||0.135||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.135
71129843|NCT00536471|141764237|SUPERIORITY_OR_OTHER|||||||0.175||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.175
71129844|NCT00536471|141764237|SUPERIORITY_OR_OTHER|||||||1||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||1.000
71129845|NCT00536471|141764238|SUPERIORITY_OR_OTHER|||||||0.175||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.175
71129846|NCT00536471|141764238|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.002
71129847|NCT00536471|141764238|SUPERIORITY_OR_OTHER|||||||0.576||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.576
71129848|NCT00536471|141764238|SUPERIORITY_OR_OTHER|||||||0.676||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.676
71129849|NCT00536471|141764239|SUPERIORITY_OR_OTHER|||||||0.675||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.675
71129850|NCT00536471|141764239|SUPERIORITY_OR_OTHER|||||||0.139||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.139
71129851|NCT00536471|141764239|SUPERIORITY_OR_OTHER|||||||0.576||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.576
71129852|NCT00536471|141764239|SUPERIORITY_OR_OTHER|||||||0.676||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.676
71129853|NCT00536471|141764240|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.007
70946907|NCT05178979|141394047|SUPERIORITY||Wald Chi-square|10.84||||0.004|TWO_SIDED|||||Models control for clinic, cadre, and gender and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.004
71129854|NCT00536471|141764240|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.031
71129855|NCT00536471|141764240|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Tension-Anxiety (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.020
71129856|NCT00536471|141764240|SUPERIORITY_OR_OTHER|||||||0.324||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Tension-Anxiety (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.324
71129857|NCT00536471|141764240|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Depression-Dejection (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.010
71129858|NCT00536471|141764240|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Depression-Dejection (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.005
71129859|NCT00536471|141764240|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Anger-Hostility (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.010
71129860|NCT00536471|141764240|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Anger-Hostility (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.019
71129861|NCT00536471|141764240|SUPERIORITY_OR_OTHER|||||||0.201||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Vigor-Activity (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.201
71129862|NCT00536471|141764240|SUPERIORITY_OR_OTHER|||||||0.069||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Vigor-Activity (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.069
71129863|NCT00536471|141764240|SUPERIORITY_OR_OTHER|||||||0.368||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Fatigue-Inertia (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.368
71129864|NCT00536471|141764240|SUPERIORITY_OR_OTHER|||||||0.435||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Fatigue-Inertia (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.435
71129865|NCT00536471|141764240|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Confusion-Bewilderment (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.090
71129866|NCT00536471|141764240|SUPERIORITY_OR_OTHER|||||||0.313||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Confusion-Bewilderment (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.313
71129867|NCT00536471|141764241|SUPERIORITY_OR_OTHER|||||||0.639||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.639
71129868|NCT00536471|141764241|SUPERIORITY_OR_OTHER|||||||0.584||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.584
71129869|NCT00536471|141764241|SUPERIORITY_OR_OTHER|||||||0.251||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Tension-Anxiety (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.251
71129870|NCT00536471|141764241|SUPERIORITY_OR_OTHER|||||||0.265||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Tension-Anxiety (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.265
71129871|NCT00536471|141764241|SUPERIORITY_OR_OTHER|||||||0.366||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Depression-Dejection (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.366
71129872|NCT00536471|141764241|SUPERIORITY_OR_OTHER|||||||0.257||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Depression-Dejection (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.257
71129873|NCT00536471|141764241|SUPERIORITY_OR_OTHER|||||||0.426||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Anger-Hostility (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.426
71129874|NCT00536471|141764241|SUPERIORITY_OR_OTHER|||||||0.234||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Anger-Hostility (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.234
71129875|NCT00536471|141764241|SUPERIORITY_OR_OTHER|||||||0.765||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Vigor-Activity (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.765
71129876|NCT00536471|141764241|SUPERIORITY_OR_OTHER|||||||0.522||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Vigor-Activity (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.522
71129877|NCT00536471|141764241|SUPERIORITY_OR_OTHER|||||||0.986||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Fatigue-Inertia (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.986
71129878|NCT00536471|141764241|SUPERIORITY_OR_OTHER|||||||0.602||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Fatigue-Inertia (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.602
71129879|NCT00536471|141764241|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Confusion-Bewilderment (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.110
71129880|NCT00536471|141764241|SUPERIORITY_OR_OTHER|||||||0.505||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Confusion-Bewilderment(Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.505
71129881|NCT00536471|141764242|SUPERIORITY_OR_OTHER|||||||0.366||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Work Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.366
71129882|NCT00536471|141764242|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Work Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.065
71129883|NCT00536471|141764242|SUPERIORITY_OR_OTHER|||||||0.229||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Social Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.229
71129884|NCT00536471|141764242|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Social Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.044
71129885|NCT00536471|141764242|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Family Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.092
71129886|NCT00536471|141764242|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Family Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.002
71129887|NCT00536471|141764242|SUPERIORITY_OR_OTHER|||||||0.142||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score(Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.142
71129888|NCT00536471|141764242|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.005
71129889|NCT00536471|141764243|SUPERIORITY_OR_OTHER|||||||0.921||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Work Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.921
71129890|NCT00536471|141764243|SUPERIORITY_OR_OTHER|||||||0.895||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Work Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.895
71129891|NCT00536471|141764243|SUPERIORITY_OR_OTHER|||||||0.789||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Social Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.789
71129892|NCT00536471|141764243|SUPERIORITY_OR_OTHER|||||||0.761||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Social Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.761
71129893|NCT00536471|141764243|SUPERIORITY_OR_OTHER|||||||0.519||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Family Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.519
71129894|NCT00536471|141764243|SUPERIORITY_OR_OTHER|||||||0.755||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Family Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.755
71129895|NCT00536471|141764243|SUPERIORITY_OR_OTHER|||||||0.829||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.829
71129896|NCT00536471|141764243|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.723
71129897|NCT00536471|141764244|SUPERIORITY_OR_OTHER|||||||0.753||95.0||||P-value for Direct Treatment Effect|Regression, Linear|||||||0.753
71129898|NCT00536471|141764244|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||P-value for Direct Treatment Effect|Regression, Linear|||||||0.036
71129899|NCT00536471|141764246|SUPERIORITY_OR_OTHER|||||||0.342||95.0||||P-value for Direct Treatment Effect|Regression, Linear|||||||0.342
71129900|NCT00536471|141764246|SUPERIORITY_OR_OTHER|||||||0.111||95.0||||P-value for Direct Treatment Effect|Regression, Linear|||||||0.111
71129901|NCT00536471|141764248|SUPERIORITY_OR_OTHER|||||||0.302||95.0||||P-value for 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.302
71129902|NCT00536471|141764248|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value for 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.029
71129903|NCT00536471|141764248|SUPERIORITY_OR_OTHER|||||||0.325||95.0||||P-value for 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.325
71129904|NCT00536471|141764248|SUPERIORITY_OR_OTHER|||||||0.423||95.0||||P-value for 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.423
71129905|NCT00536471|141764249|SUPERIORITY_OR_OTHER|||||||0.731||95.0||||P-value for 12 Week HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.731
71129906|NCT00536471|141764249|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for 12 Week HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.022
71129907|NCT00536471|141764249|SUPERIORITY_OR_OTHER|||||||0.948||95.0||||P-value for 12 Week QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.948
71129908|NCT00536471|141764249|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for 12 Week QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.022
70859088|NCT04340063|141204689|OTHER||Odds Ratio, log|0.4|||<|0.001|TWO_SIDED|95.0|0.25|0.55||Effect of time (pre-, mid-, and post- assessments)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the effect of training (pre-, mid-, and post- assessments). Random effect of participant was used and fixed effects were time (assessment order) and a time by group interaction (Treadmill or Movement Amplification). A binomial distribution was used for this model.||0.55|0.25|<0.001
70859089|NCT04340063|141204689|OTHER||Odds Ratio, log|-0.03||||0.8|TWO_SIDED|95.0|-0.22|0.16||Interaction effect for time (pre-, mid-, and post- assessments) by group (Movement Amplification)|Mixed Models Analysis|||||0.16|-0.22|0.8
70859090|NCT04340063|141204689|OTHER||Odds Ratio, log|0.09||||0.5|TWO_SIDED|95.0|-0.18|0.36||Effect of time (post-training and follow-up assessments)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the post-training and follow-up assessments if an effect was found during training. Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used. A binomial distribution was used for this model.||0.36|-0.18|0.5
70859091|NCT04340063|141204689|OTHER||Odds Ratio, log|-0.07||||0.6|TWO_SIDED|95.0|-0.31|0.17||Interaction effect of time (post-training and follow-up assessments) by group (Movement Amplification)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the post-training and follow-up assessments if an effect was found during training. Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used. A binomial distribution was used for this model.||0.17|-0.31|0.6
70859092|NCT04340063|141204690|OTHER||Slope|0.06||||0.8|TWO_SIDED|95.0|-0.5|0.62||Effect of time (pre-, mid-, and post- assessments)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the effect of training (pre-, mid-, and post- assessments). Random effect of participant and fixed effects of time (assessment order) and time by group (Treadmill or Movement Amplification) interaction were used||0.62|-0.50|0.8
70859093|NCT04340063|141204690|OTHER||Slope|-0.7||||0.012|TWO_SIDED|95.0|-1.2|-0.16||Interaction effect of time by group (Movement Amplification)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the effect of training (pre-, mid-, and post- assessments). Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used.||-0.16|-1.2|0.012
70859094|NCT04340063|141204690|OTHER||Slope|0.26||||0.3|TWO_SIDED|95.0|-0.22|0.75||Effect of time (post-training to follow-up)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the post-training and follow-up assessments if an effect was found during training. Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used.||0.75|-0.22|0.3
71129909|NCT00536471|141764249|SUPERIORITY_OR_OTHER|||||||0.95||95.0||||P-value for 9 Month HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.950
71129910|NCT00536471|141764249|SUPERIORITY_OR_OTHER|||||||0.442||95.0||||P-value for 9 Month HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.442
70859095|NCT04340063|141204690|OTHER||Slope|-0.2||||0.4|TWO_SIDED|95.0|-0.69|0.29||Interaction effect of time (post-training to follow-up) by group|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the post-training and follow-up assessments if an effect was found during training. Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used.||0.29|-0.69|0.4
70946908|NCT05178979|141394047|SUPERIORITY||unstandardized beta|0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up|Regression, Linear|Models control for clinic, cadre, and gender and are adjusted for multiple time points.||||||<0.001
70859096|NCT04340063|141204691|OTHER||Slope|-52.0||||0.9|TWO_SIDED|95.0|-651.0|456.0||Effect of time (pre-, mid-, and post- assessments)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the effect of training (pre-, mid-, and post- assessments). Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used.||456|-651|0.9
71129911|NCT00536471|141764249|SUPERIORITY_OR_OTHER|||||||0.218||95.0||||P-value for 9 Month QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.218
70859097|NCT04340063|141204691|OTHER||Slope|79.0||||0.8|TWO_SIDED|95.0|-622.0|780.0||Interaction effect of time by group (Movement Amplification)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the effect of training (pre-, mid-, and post- assessments). Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used.||780|-622|0.8
70859098|NCT01857583|141204709|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|12.6|||||TWO_SIDED|95.0|-10.0|33.6|||ANCOVA|||||33.6|-10.0|
70946909|NCT05178979|141394047|SUPERIORITY||unstandardized beta|-0.02|STANDARD_ERROR_OF_MEAN|0.09||0.86|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up|Regression, Linear|Models control for clinic, cadre, and gender and are adjusted for multiple time points.||||||0.86
71129912|NCT00536471|141764249|SUPERIORITY_OR_OTHER|||||||0.648||95.0||||P-value for 9 Month QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.648
70859099|NCT01857583|141204709|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|17.3|||||TWO_SIDED|95.0|-10.2|42.1|||ANCOVA|||||42.1|-10.2|
70859100|NCT04894916|141204725|OTHER|single group|mean|81.9|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||"One-sample t-test comparing the sample mean to the threshold value of 71 indicative of good usability. The null hypothesis: true mean is equal to 71."||||<0.001
70859101|NCT04894916|141204728|SUPERIORITY||Mean Difference (Net)|0.73|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
70859102|NCT04894916|141204729|OTHER||Mean Difference (Net)|1.17||||0.08|TWO_SIDED||||||t-test, 2 sided|||||||0.08
71129913|NCT00536471|141764250|SUPERIORITY_OR_OTHER|||||||0.653||95.0||||P-value for 12 week HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.653
71129914|NCT00536471|141764250|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value for 12 week HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.016
71129915|NCT00536471|141764250|SUPERIORITY_OR_OTHER|||||||0.665||95.0||||P-value for 12 week QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.665
70946910|NCT05178979|141394048|SUPERIORITY||Wald Chi-square|21.42|||<|0.001|TWO_SIDED|||||Models control for clinic, cadre, and gender and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Logistic||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||<0.001
70946911|NCT05178979|141394048|SUPERIORITY||unstandardized beta|0.04|STANDARD_ERROR_OF_MEAN|0.14||0.81|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, cadre, and gender and are adjusted for multiple time points.||update||||0.81
71129916|NCT00536471|141764250|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||P-value for 12 week QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.127
71129917|NCT00536471|141764251|SUPERIORITY_OR_OTHER|||||||0.475||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 1 Average Pain Severity 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.475
71129918|NCT00536471|141764251|SUPERIORITY_OR_OTHER|||||||0.561||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 1 Average Pain Severity 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.561
71129919|NCT00536471|141764251|SUPERIORITY_OR_OTHER|||||||0.213||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 7 How Bothered by Pain 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.213
71129920|NCT00536471|141764251|SUPERIORITY_OR_OTHER|||||||0.536||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 7 How Bothered by Pain 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.536
71129921|NCT00536471|141764251|SUPERIORITY_OR_OTHER|||||||0.158||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 1 Average Pain Severity 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.158
71129922|NCT00536471|141764251|SUPERIORITY_OR_OTHER|||||||0.759||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 1 Average Pain Severity 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.759
71129923|NCT00536471|141764251|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 7 How Bothered by Pain 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.190
71129924|NCT00536471|141764251|SUPERIORITY_OR_OTHER|||||||0.852||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 7 How Bothered by Pain 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.852
71129925|NCT00536471|141764252|SUPERIORITY_OR_OTHER|||||||0.032||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.032
71129926|NCT00536471|141764252|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||<0.001
71129927|NCT00536471|141764252|SUPERIORITY_OR_OTHER|||||||0.705||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.705
71129928|NCT00536471|141764252|SUPERIORITY_OR_OTHER|||||||0.388||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.388
71129929|NCT00536471|141764253|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.161
71129930|NCT00536471|141764253|SUPERIORITY_OR_OTHER|||||||0.198||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.198
71129931|NCT00536471|141764253|SUPERIORITY_OR_OTHER|||||||0.982||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.982
71129932|NCT00536471|141764253|SUPERIORITY_OR_OTHER|||||||0.407||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.407
71129933|NCT00536471|141764254|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.001
71129934|NCT00536471|141764254|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.006
70859103|NCT04894916|141204730|OTHER|||||||0.68|||||||McNemar|||Analysis for pre-post change in knowledge of definition of A1C||||0.68
70859104|NCT04894916|141204730|OTHER|||||||0.18|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for hemoglobin A1c.||||0.18
70859105|NCT04894916|141204730|OTHER|||||||0.18|||||||McNemar|||Analysis for pre-post change in knowledge of definition of systolic blood pressure||||0.18
70859106|NCT04894916|141204730|OTHER|||||||0.17|||||||McNemar|||Analysis of pre-post change in knowledge of goal range for systolic blood pressure||||0.17
70859107|NCT04894916|141204730|OTHER|||||||0.33|||||||McNemar|||Analysis of pre-post change in knowledge of definition of LDL cholesterol||||0.33
70859108|NCT04894916|141204730|OTHER|||||||0.4|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for LDL cholesterol||||0.40
70859109|NCT04894916|141204730|OTHER|||||||1|||||||McNemar|||Analysis of pre-post change in knowledge of definition of flu vaccine||||1.00
70859110|NCT04894916|141204730|OTHER|||||||0.37|||||||McNemar|||Analysis of pre-post change in knowledge of recommended frequency of flu vaccination||||0.37
70859111|NCT04894916|141204731|OTHER||Mean Difference (Net)|-0.71||||0.16|TWO_SIDED||||||t-test, 2 sided|||||||0.16
70859112|NCT04894916|141204732|OTHER|||||||0.03|||||||McNemar|||Analysis of pre-post change in interest in information about how my diabetes health data compares to other patients like me (i.e., social comparison information)||||0.03
70859113|NCT04894916|141204732|OTHER|||||||0.45|||||||McNemar|||Analysis of pre-post change in interest in information about how their diabetes health data compares to the goal range (i.e., goal-based comparison information)||||0.45
70859114|NCT04894916|141204732|OTHER|||||||0.17|||||||McNemar|||Analysis of pre-post change in agreement with statement: 'Information about how my diabetes health data compares to other patients like me \[social comparison information\] is useful.||||0.17
70859115|NCT04894916|141204732|OTHER|||||||0.62|||||||McNemar|||Analysis of pre-post change in agreement with statement: 'Information about how my diabetes health data compares to the goals range \[goal-based comparison information\] is useful.||||0.62
70859116|NCT04894916|141204734|OTHER||Mean Difference (Net)|0.09||||0.53|TWO_SIDED||||||t-test, 2 sided|||||||0.53
70859117|NCT04894916|141204735|OTHER||Mean Difference (Net)|0.03||||0.86|TWO_SIDED||||||t-test, 2 sided|||||||0.86
70859118|NCT04894916|141204736|OTHER||Mean Difference (Net)|0.28||||0.22|TWO_SIDED||||||t-test, 2 sided|||||||0.22
70859119|NCT04894916|141204737|OTHER||Mean Difference (Net)|0.25||||0.21|TWO_SIDED||||||t-test, 2 sided|||||||0.21
70859120|NCT04894916|141204738|OTHER||Mean Difference (Net)|-0.39||||0.18|TWO_SIDED||||||t-test, 2 sided|||||||0.18
70859121|NCT00562627|141204739|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANOVA|||||||0.009
70859122|NCT00562627|141204740|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|||||||0.001
70859123|NCT00562627|141204741|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
70859124|NCT01709578|141204744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.711|||<|0.0001|TWO_SIDED|95.0|1.73|4.247||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 150 mg q2w vs Placebo q2w|A hierarchical testing procedure was used to control type I error rate at 0.05 and handle multiple endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level.||4.247|1.730|<0.0001
70859125|NCT01709578|141204744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.284|||<|0.0001|TWO_SIDED|95.0|2.108|5.115||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.115|2.108|<0.0001
70859126|NCT01709578|141204745|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.202||||0.0007|TWO_SIDED|95.0|-0.318|-0.086||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-0.086|-0.318|0.0007
70859127|NCT01709578|141204745|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21||||0.0004|TWO_SIDED|95.0|-0.325|-0.095||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-0.095|-0.325|0.0004
70859128|NCT01709578|141204746|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.971|||<|0.0001|TWO_SIDED|95.0|-1.283|-0.658||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-0.658|-1.283|<0.0001
70859129|NCT01709578|141204746|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.444|||<|0.0001|TWO_SIDED|95.0|-1.752|-1.135||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-1.135|-1.752|<0.0001
70859130|NCT01709578|141204747|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.958|||<|0.0001|TWO_SIDED|95.0|1.764|4.959||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||4.959|1.764|<0.0001
70859131|NCT01709578|141204747|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.374|||<|0.0001|TWO_SIDED|95.0|2.045|5.566||Threshold for significance was 0.025 level|Mantel Haenszel||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.566|2.045|<0.0001
70859132|NCT01709578|141204748|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.607||||0.0002|TWO_SIDED|95.0|1.774|7.332||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||7.332|1.774|0.0002
70859133|NCT01709578|141204748|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.653||||0.0056|TWO_SIDED|95.0|1.308|5.383||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.383|1.308|0.0056
70859134|NCT01709578|141204749|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.622|||<|0.0001|TWO_SIDED|95.0|2.339|9.132||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||9.132|2.339|<0.0001
71129935|NCT00536471|141764254|SUPERIORITY_OR_OTHER|||||||0.231||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.231
70859135|NCT01709578|141204749|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.801|||<|0.0001|TWO_SIDED|95.0|2.948|11.413||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||11.413|2.948|<0.0001
71129936|NCT00536471|141764254|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.040
71129937|NCT00536471|141764255|SUPERIORITY_OR_OTHER|||||||0.914||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Systolic Blood Pressure 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.914
71129938|NCT00536471|141764255|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Systolic Blood Pressure 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.011
71129939|NCT00536471|141764255|SUPERIORITY_OR_OTHER|||||||0.296||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Diastolic Blood Pressure 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.296
71129940|NCT00536471|141764255|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Diastolic Blood Pressure 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.034
71129941|NCT00536471|141764255|SUPERIORITY_OR_OTHER|||||||0.874||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Systolic Blood Pressure (SBP) 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.874
71129942|NCT00536471|141764255|SUPERIORITY_OR_OTHER|||||||0.614||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Systolic Blood Pressure (SBP) 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.614
71129943|NCT00536471|141764255|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Diastolic Blood Pressure (DBP) 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.146
71129944|NCT00536471|141764255|SUPERIORITY_OR_OTHER|||||||0.877||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Diastolic Blood Pressure (DBP) 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.877
71129945|NCT00536471|141764256|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.012
71129946|NCT00536471|141764256|SUPERIORITY_OR_OTHER|||||||0.045||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.045
71129947|NCT00536471|141764256|SUPERIORITY_OR_OTHER|||||||0.701||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.701
71129948|NCT00536471|141764256|SUPERIORITY_OR_OTHER|||||||0.081||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.081
71129949|NCT00536471|141764257|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.013
71129950|NCT00536471|141764257|SUPERIORITY_OR_OTHER|||||||0.672||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.672
71129951|NCT00536471|141764257|SUPERIORITY_OR_OTHER|||||||0.874||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.874
71129952|NCT00536471|141764257|SUPERIORITY_OR_OTHER|||||||0.39||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.390
71129953|NCT00536471|141764262|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||P-value for Bilirubin - 12 Week Change.|ANOVA|||||||0.046
71129954|NCT00536471|141764262|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||P-value for Creatinine - 12 Week Change.|ANOVA|||||||0.031
71129955|NCT00536471|141764262|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Uric Acid - 12 Week Change.|ANOVA|||||||0.003
71129956|NCT00536471|141764262|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||P-value for Bilirubin - 9 Month Change.|ANOVA|||||||0.033
71129957|NCT00536471|141764262|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Uric Acid - 9 Month Change.|ANOVA|||||||0.013
71129958|NCT00536471|141764263|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||P-value for Hematocrit - 12 Week Change.|ANOVA|||||||0.037
71129959|NCT00536471|141764263|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value for Hematocrit - 9 Month Change.|ANOVA|||||||0.029
71129960|NCT00536471|141764264|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for MCV - 12 Week Change.|ANOVA|||||||0.013
71129961|NCT00536471|141764264|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||P-value for MCV - 9 Month Change.|ANOVA|||||||0.014
70859136|NCT01709578|141204750|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.306|||<|0.0001|TWO_SIDED|95.0|-10.444|-4.167||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-4.167|-10.444|<0.0001
70859137|NCT01709578|141204750|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.727|||<|0.0001|TWO_SIDED|95.0|-12.833|-6.622||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-6.622|-12.833|<0.0001
70859138|NCT01709578|141204751|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.183||||0.0078|TWO_SIDED|95.0|-0.318|-0.048||Threshold for significance was 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-0.048|-0.318|0.0078
71129962|NCT00536471|141764265|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for Chloride - 12 Week Change.|ANOVA|||||||0.022
70859139|NCT01709578|141204751|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.242||||0.0004|TWO_SIDED|95.0|-0.376|-0.109||Threshold for significance was 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-0.109|-0.376|0.0004
70859140|NCT01709578|141204752|SUPERIORITY_OR_OTHER||LS Mean Difference|3.25||||0.0004|TWO_SIDED|95.0|1.45|5.049||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.049|1.450|0.0004
70859141|NCT01709578|141204752|SUPERIORITY_OR_OTHER||LS Mean Difference|4.075|||<|0.0001|TWO_SIDED|95.0|2.305|5.846||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.846|2.305|<0.0001
70859142|NCT01709578|141204753|SUPERIORITY_OR_OTHER||LS Mean Difference|1.515||||0.2026|TWO_SIDED|95.0|-0.818|3.848||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||3.848|-0.818|0.2026
70859143|NCT01709578|141204753|SUPERIORITY_OR_OTHER||LS Mean Difference|2.013||||0.0854|TWO_SIDED|95.0|-0.282|4.309||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||4.309|-0.282|0.0854
70859144|NCT01314911|141204795|SUPERIORITY||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|4.6||0.0097|TWO_SIDED|95.0|-21.4|-3.0||P-value was not adjusted for multiple interim analyses.|Z-test, 2-sided|Comparison of randomized arms was based on the normal approximation to the binomial distribution.|The difference in percents was calculated as the percent detectable in the Oseltamivir arm minus the percent detectable in the Placebo arm.|Assuming that pooled percentage of participants with virus detectable by PCR at Day 3 is 50%, assuming that the Oseltamivir arm was better than the placebo arm and that the detectable rate in the Oseltamivir arm was 42.5% compared to 57.5% in the placebo arm (a 15% reduction), and assuming 10% subjects with missing qPCR at Day 3, in a two-sided, two-sample 0.05-level t- test with 546 participants combined across both arms, there was 90% power.||-3.0|-21.4|0.0097
70859145|NCT01314911|141204798|SUPERIORITY|||||||0.0243||||||P-value was not adjusted for multiple interim analyses.|Wilcoxon (Mann-Whitney)|||||||0.0243
70859146|NCT01314911|141204799|SUPERIORITY|||||||0.41||||||P-value was not adjusted for multiple interim analyses.|Log Rank|||||||0.41
70859147|NCT01314911|141204800|SUPERIORITY|||||||0.88||||||P-value was not adjusted for multiple interim analyses.|Log Rank|||||||0.88
70859148|NCT01314911|141204801|SUPERIORITY|||||||0.7461||||||P-value was not adjusted for multiple interim analyses.|Log Rank|||||||0.7461
70859149|NCT01314911|141204802|SUPERIORITY|||||||0.1501||||||P-value was not adjusted for multiple interim analyses.|Log Rank|||||||0.1501
70859150|NCT01314911|141204803|SUPERIORITY|||||||0.3025||||||P-value was not adjusted for multiple interim analyses.|Log Rank|||||||0.3025
70859151|NCT01314911|141204804|SUPERIORITY|||||||0.5466||||||P-value was not adjusted for multiple interim analyses.|Log Rank|||||||0.5466
70859152|NCT01314911|141204806|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.5311|TWO_SIDED|95.0|-1.4|3.0||P-value was not adjusted for multiple interim analyses.|two-sample binomial exact test|The two-sample binomial exact test was performed in PROC STATXACT.|The difference in percents was calculated as the percent in the Oseltamivir arm minus the percent in the placebo arm.|||3.0|-1.4|0.5311
70859153|NCT01314911|141204807|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.8498|TWO_SIDED|95.0|-3.8|4.7||P-value was not adjusted for multiple interim analyses.|Z test||The difference in percents was calculated as the percent in the Oseltamivir arm minus the percent in the placebo arm.|This test compared the difference in percentages of participants with at least one complication between two randomized arms.||4.7|-3.8|0.8498
70859154|NCT01314911|141204809|SUPERIORITY||Mean Difference (Final Values)|-13.6||||0.0021|TWO_SIDED|95.0|-22.2|-5.1||P-value was not adjusted for multiple interim analyses.|Z test||||The difference in percents was calculated as the percent with detectable in the Oseltamivir arm minus the percent with detectable in the placebo arm.|-5.1|-22.2|0.0021
70859155|NCT01314911|141204812|SUPERIORITY|||||||0.022||||||P-value was not adjusted for multiple interim analyses.|Wilcoxon (Mann-Whitney)|||||||0.022
70859156|NCT02284178|141204832|SUPERIORITY|||||||0.432|||||||GEE analysis|||||||0.432
70859157|NCT02284178|141204833|SUPERIORITY|||||||0.684|||||||GEE|||||||0.684
70859158|NCT02284178|141204834|SUPERIORITY|||||||0.858|||||||Chi-squared|||||||0.858
70859159|NCT02284178|141204836|SUPERIORITY|||||||0.46|||||||GEE analysis|||||||0.460
71129963|NCT00536471|141764265|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||P-value for Urea Nitrogen - 12 Week Change.|ANOVA|||||||0.044
71129964|NCT00536471|141764265|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value for Chloride - 9 Month Change.|ANOVA|||||||0.004
71129965|NCT00536471|141764265|SUPERIORITY_OR_OTHER|||||||0.045||95.0||||P-value for Cholesterol - 9 Month Change.|ANOVA|||||||0.045
71129966|NCT00536471|141764265|SUPERIORITY_OR_OTHER|||||||0.043||95.0||||P-value for Sodium - 9 Month Change.|ANOVA|||||||0.043
71129967|NCT00536471|141764266|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value for 12 Week Change.|ANOVA|||||||0.017
70859160|NCT02284178|141204837|SUPERIORITY|||||||0.214|||||||t-test, 2 sided|||||||0.214
70859161|NCT02284178|141204838|SUPERIORITY|||||||0.155|||||||t-test, 2 sided|||||||0.155
70859162|NCT02284178|141204839|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.050
70859163|NCT03569293|141204855|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|63.4|||<|0.001|TWO_SIDED|95.0|57.1|69.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||69.8|57.1|<0.001
70859164|NCT03569293|141204855|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|53.3|||<|0.001|TWO_SIDED|95.0|46.4|60.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||60.2|46.4|<0.001
70859165|NCT03569293|141204856|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|53.6|||<|0.001|TWO_SIDED|95.0|47.2|60.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response rate difference = Upadacitinib - Placebo|||60.0|47.2|<0.001
70859166|NCT03569293|141204856|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|39.8|||<|0.001|TWO_SIDED|95.0|33.2|46.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response rate difference = Upadacitinib - Placebo|||46.4|33.2|<0.001
70859167|NCT03569293|141204857|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|48.2|||<|0.001|TWO_SIDED|95.0|41.3|55.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||55.0|41.3|<0.001
70859168|NCT03569293|141204857|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|40.5|||<|0.001|TWO_SIDED|95.0|33.5|47.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||47.5|33.5|<0.001
70859169|NCT03569293|141204858|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|57.8|||<|0.001|TWO_SIDED|95.0|51.5|64.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||64.1|51.5|<0.001
70859170|NCT03569293|141204858|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|45.1|||<|0.001|TWO_SIDED|95.0|38.6|51.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||51.7|38.6|<0.001
70859171|NCT03569293|141204859|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|62.3|||<|0.001|TWO_SIDED|95.0|56.3|68.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||68.3|56.3|<0.001
70859172|NCT03569293|141204859|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|47.1|||<|0.001|TWO_SIDED|95.0|40.7|53.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||53.4|40.7|<0.001
70946912|NCT05178979|141394048|SUPERIORITY||unstandardized beta|-0.22|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, cadre, and gender and are adjusted for multiple time points.||update||||<0.001
70946913|NCT05178979|141394049|SUPERIORITY||Wald Chi-square|150.43|||<|0.001|TWO_SIDED|||||Models control for clinic, cadre, and gender and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||<0.001
70859173|NCT03569293|141204860|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|43.9|||<|0.001|TWO_SIDED|95.0|37.7|50.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||50.0|37.7|<0.001
70872050|NCT02155608|141229483|SUPERIORITY||||||<|0.0001||||||p \< .05 for statistical significance|Mixed Models Analysis|Time: F=39.97, df = 1/228||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||<.0001
71129968|NCT00536471|141764266|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for 9 Month Change.|ANOVA|||||||0.003
70859174|NCT03569293|141204860|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|34.5|||<|0.001|TWO_SIDED|95.0|28.6|40.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||40.5|28.6|<0.001
70859175|NCT03569293|141204861|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|19.2|||<|0.001|TWO_SIDED|95.0|14.6|23.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||23.9|14.6|<0.001
71129969|NCT00536471|141764267|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||ANOVA|||||||0.033
71129970|NCT00536471|141764268|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||ANOVA|||||||0.045
71129971|NCT00536471|141764269|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||P-value for Lymphocytes - High.|Fisher Exact|||||||0.041
71129972|NCT00536471|141764269|SUPERIORITY_OR_OTHER|||||||0.048||95.0||||P-value for Potassium - Low.|Fisher Exact|||||||0.048
71129973|NCT00536471|141764270|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-value for Lymphocytes - High.|Fisher Exact|||||||0.012
71129974|NCT00536471|141764270|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||P-value for Potassium - Low.|Fisher Exact|||||||0.049
71129975|NCT00536471|141764271|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-value for Lymphocytes - High.|Fisher Exact|||||||0.012
71129976|NCT00536471|141764271|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||P-value for Hemoglobin - Low.|Fisher Exact|||||||0.038
71129977|NCT02920749|141764336|SUPERIORITY_OR_OTHER||||||<|0.05||||||The P value less than 0.05 was considered to be significant. With type I α = 5% and with type II (power) of 90%, we therefore needed 27 patients/group.|ANOVA|||Statistical analysis was carried out with SPSS version 21 for Windows (IBM Corporation) software. All data are expressed as means ± SD. Mann-Whitney test was performed to assess the differences between patient subgroups.||||<0.05
71129978|NCT02920749|141764337|SUPERIORITY_OR_OTHER||||||<|0.05||||||The P value less than 0.05 was considered to be significant. With type I α = 5% and with type II (power) of 90%, we therefore needed 27 patients/group.|ANOVA|||Statistical analysis was carried out with SPSS version 21 for Windows (IBM Corporation) software. All data are expressed as means ± SD. Mann-Whitney test was performed to assess the differences between patient subgroups.||||<0.05
71129979|NCT00596830|141764369|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.179||||0.064|TWO_SIDED|95.0|0.99|1.404||The p-value stated is the 2-sided p-value from the log rank test stratified by gender, prior adjuvant chemotherapy, and histology.|Log Rank|||||1.404|0.990|0.064
71129980|NCT00596830|141764370|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.103||||0.27|TWO_SIDED|95.0|0.925|1.315||2-sided p-value is from the unstratified log-rank test|Log Rank||HR was based on the Cox proportional hazards model|||1.315|0.925|0.270
71129981|NCT00596830|141764371|SUPERIORITY_OR_OTHER||Risk difference|-1.472||||0.685|TWO_SIDED|95.0|-8.6|5.6|||Chi-squared||Risk difference confidence interval was calculated based on a normal distribution.|||5.6|-8.6|0.685
71129982|NCT00880191|141764399|SUPERIORITY_OR_OTHER|||||||0.2344|TWO_SIDED||||||Fisher Exact|||Complete Responders by Arm - Days 2-6, the primary analysis utilizes Fisher's exact test to compare the percentage of complete responders in each group (dex/gabapentin vs. dex/placebo), with complete response being defined as no emetic episodes and no use of rescue therapy for days 2 through 6. If a patient does not complete the study or does not provide complete data, they will be assumed to be a non-responder.||||0.2344
71129983|NCT00880191|141764400|SUPERIORITY_OR_OTHER|||||||0.3694|TWO_SIDED||||||Fisher Exact|||The primary analysis described above was repeated using a slightly different alternate definition of complete response: no emetic episodes, no more than a mean of 2.5 on the nausea numeric analogue scale, and no rescue agents.||||0.3694
71129984|NCT01919801|141764425|SUPERIORITY_OR_OTHER_LEGACY|||||||0.633||||||Test was performed using a weighted log-rank test called the Peto-Prentice test with a global 2-sided significance level of 5% after adjusting for stratification factors (race, and severity) in the ITT population.|Adjusted Peto-Prentice|||A total of 121 participants were analysed, however 3 participants did not receive the study medication and were censored at time 0.||||0.633
71129985|NCT01843062|141764435|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8205|TWO_SIDED|95.0|0.61|1.87||The primary endpoint was to be considered statistically significant if the 2-sided p-value was less than 0.05. P-value and confidence intervals (CIs) were calculated using profile likelihood.|Regression, Logistic|||Selumetinib in combination with RAI was compared with placebo in combination with RAI. The analysis was performed using a logistic regression model including treatment as the only covariate. An odds ratio \>1 favours selumetinib in combination with RAI.||1.87|0.61|0.8205
71129986|NCT01843062|141764436|SUPERIORITY||Odds Ratio (OR)|0.85||||0.6549|TWO_SIDED|95.0|0.42|1.73||P-value and CIs were calculated using profile likelihood.|Regression, Logistic|||Selumetinib in combination with RAI was compared with placebo in combination with RAI. The analysis was performed using a logistic regression model including treatment as the only covariate. An odds ratio \>1 favours selumetinib in combination with RAI.||1.73|0.42|0.6549
71129987|NCT01843062|141764437|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8205|TWO_SIDED|95.0|0.61|1.87||P-value and CIs were calculated using profile likelihood.|Regression, Logistic|||Selumetinib in combination with RAI was compared with placebo in combination with RAI. The analysis was performed using a logistic regression model including treatment as the only covariate. An odds ratio \>1 favours selumetinib in combination with RAI.||1.87|0.61|0.8205
71129988|NCT01843062|141764438|SUPERIORITY||Odds Ratio (OR)|0.85||||0.6549|TWO_SIDED|95.0|0.42|1.73||P-value and CIs were calculated using profile likelihood.|Regression, Logistic|||Selumetinib in combination with RAI was compared with placebo in combination with RAI. The analysis was performed using a logistic regression model including treatment as the only covariate. An odds ratio \>1 favours selumetinib in combination with RAI.||1.73|0.42|0.6549
71129989|NCT01677858|141764439|OTHER||Maximum Tolerated Dose (mg/m²)|70.0|||||TWO_SIDED|||||||||||||
70859176|NCT03569293|141204861|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|14.6|||<|0.001|TWO_SIDED|95.0|10.3|18.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||18.8|10.3|<0.001
70859177|NCT03569293|141204862|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|8.1|||<|0.001|TWO_SIDED|95.0|3.8|12.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||12.5|3.8|<0.001
70946914|NCT05178979|141394049|SUPERIORITY||unstandardized beta|0.17|STANDARD_ERROR_OF_MEAN|0.05||0.002|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up|Regression, Linear|||||||0.002
70946915|NCT05178979|141394049|SUPERIORITY||unstandardized beta|0.13|STANDARD_ERROR_OF_MEAN|0.06||0.03|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up|Regression, Linear|||||||0.03
71129990|NCT00773747|141764455|SUPERIORITY||Cox Proportional Hazard|0.774|||=|0.01|TWO_SIDED|95.0|0.636|0.941|||Regression, Cox|||Cox model stratified by myeloma stage at enrollment, history of a bone marrow transplant, and number of prior treatment regimens, with a single treatment covariate.||0.941|0.636|= 0.0100
71129991|NCT00773747|141764457|SUPERIORITY||Cox Proportional Hazard|0.858||||0.3496|TWO_SIDED|95.0|0.622|1.184|||Regression, Cox|||Cox model stratified by myeloma stage at enrollment, history of a bone marrow transplant, and number of prior treatment regimens, with a single treatment covariate.||1.184|0.622|0.3496
71129992|NCT04260347|141764460|OTHER||Risk Ratio (RR)|1.064||||1|TWO_SIDED|95.0|0.345|1.784|||Chi-squared||Actilyse® (alteplase) pre-approval participants were used as reference group.|||1.784|0.345|1.000
71129993|NCT04260347|141764461|OTHER||Risk Ratio (RR)|0.889||||0.254|TWO_SIDED|95.0|0.699|1.08|||Chi-squared||Actilyse® (alteplase) pre-approval participants were used as reference group.|||1.08|0.699|0.254
71129994|NCT04260347|141764462|OTHER||Risk Ratio (RR)|1.089||||0.28|TWO_SIDED|95.0|0.942|1.237|||Chi-squared||Actilyse® (alteplase) pre-approval participants were used as reference group.|||1.237|0.942|0.280
71129995|NCT04260347|141764463|OTHER||Standardized Mean Difference (SMD)|0.016||||0.916|TWO_SIDED|95.0|-0.096|0.128|||Wilcoxon (Mann-Whitney)||SMD = Difference in the mean between groups / Standard deviation Actilyse® (alteplase) pre-approval participants were used as reference group.|||0.128|-0.096|0.916
71129996|NCT04260347|141764464|OTHER||Risk Ratio (RR)|1.066||||0.561|TWO_SIDED|95.0|0.872|1.261|||Chi-squared||Actilyse® (alteplase) pre-approval participants were used as reference group.|||1.261|0.872|0.561
71129997|NCT04260347|141764465|OTHER||Risk Ratio (RR)|1.231||||0.522|TWO_SIDED|95.0|0.707|1.756|||Chi-squared||Actilyse® (alteplase) pre-approval participants were used as reference group.|||1.756|0.707|0.522
71129998|NCT04260347|141764466|OTHER||Standardized Mean Difference (SMD)|-0.021||||0.81|TWO_SIDED|95.0|-0.133|0.091|||Wilcoxon (Mann-Whitney)||SMD = Difference in mean between groups / Standard deviation Actilyse® (alteplase) pre-approval participants were used as reference group.|||0.091|-0.133|0.810
71129999|NCT04260347|141764467|OTHER||Standardized Mean Difference (SMD)|-0.085||||0.179|TWO_SIDED|95.0|-0.199|0.03|||Wilcoxon (Mann-Whitney)||SMD = Difference in mean between groups / Standard deviation Actilyse® (alteplase) pre-approval participants were used as reference group.|||0.03|-0.199|0.179
71130000|NCT04260347|141764468|OTHER||Standardized Mean Difference (SMD)|0.042||||0.275|TWO_SIDED|95.0|-0.072|0.156|||Wilcoxon (Mann-Whitney)||SMD = Difference in mean between groups / Standard deviation Actilyse® (alteplase) pre-approval participants were used as reference group.|||0.156|-0.072|0.275
71130001|NCT03549104|141764482|OTHER||||||||||||||||||We will evaluate the effects of within-group and between-group differences from baseline (Week 0) to program completion (Week 8) to calculate effect sizes for sample size estimation for a future larger study.|||
71130002|NCT03549104|141764483|OTHER||||||||||||||||||We will evaluate the effects of within-group and between-group differences from baseline (Week 0) to program completion (Week 8) to calculate effect sizes for sample size estimation for a future larger study.|||
71130003|NCT03549104|141764484|OTHER||||||||||||||||||We will evaluate the effects of within-group and between-group differences from baseline (Week 0) to program completion (Week 8) to calculate effect sizes for sample size estimation for a future larger study.|||
71130004|NCT04164732|141764490|SUPERIORITY||Median Difference (Net)|0.61||||0.5506|TWO_SIDED|80.0|-0.71|1.94|||longitudinal mixed effects (MMRM) model|||||1.94|-0.71|0.5506
71130005|NCT01868334|141764508|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Chi-squared|Chi-square tests for comparisons between-arm changes in vaccination rates between Baseline and Year 1 for RCCT study period||||||0.05
71130006|NCT01868334|141764508|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||||||Cochran-Armitage trend tests for percentage point difference between Baseline and Year 1 for RCCT study period|Cochran-Armitage trend test|||||||0.05
71130007|NCT01868334|141764509|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Chi-squared|Chi-square tests for comparisons between-arm changes in vaccination rates between pre and post intervention for Pre-post study period||||||0.05
71130008|NCT01868334|141764509|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||||||Cochran-Armitage trend tests for difference between pre and post changes in vaccination rates for Pre-Post study period|Cochran-Armitage trend test|||||||0.05
71130009|NCT02951429|141764510|SUPERIORITY||Difference of percentage of participants|3.06||||0.6527|TWO_SIDED|95.0|-11.3|17.97|||Chi-squared|||||17.97|-11.30|0.6527
71130010|NCT02951429|141764511|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.7568|TWO_SIDED|95.0|0.67|1.34|||Log Rank|Log-rank test based on the time to the first event to compare the two treatment arms.||||1.34|0.67|0.7568
71130011|NCT02951429|141764512|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.376|TWO_SIDED|95.0|0.68|1.15|||Log Rank|Log-rank test based on the time to the first event to compare the two treatment arms.||||1.15|0.68|0.3760
71130012|NCT02951429|141764513|SUPERIORITY||Difference (95% CI)|2.85||||0.7046|TWO_SIDED|95.0|-12.13|17.84|||Chi-squared|||||17.84|-12.13|0.7046
70946916|NCT05178979|141394050|SUPERIORITY||Wald Chi-square|8.72||||0.01|TWO_SIDED|||||Models control for clinic, cadre, and gender and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.01
70946917|NCT05178979|141394050|SUPERIORITY||unstandardized beta|0.42|STANDARD_ERROR_OF_MEAN|0.29||0.15|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, cadre, and gender and are adjusted for multiple time points.||||||0.15
70946918|NCT05178979|141394050|SUPERIORITY||unstandardized beta|0.32|STANDARD_ERROR_OF_MEAN|0.12||0.008|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, cadre, and gender and are adjusted for multiple time points.||||||0.008
70946919|NCT05178979|141394051|SUPERIORITY||Wald Chi-square|172.52|||<|0.001|TWO_SIDED|||||Models control for clinic and income and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||<0.001
70946920|NCT05178979|141394051|SUPERIORITY||unstandardized beta|0.14|STANDARD_ERROR_OF_MEAN|0.34||0.68|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is the 6-month follow-up|Regression, Linear|Models control for clinic and income and are adjusted for multiple time points.||||||0.68
70946921|NCT05178979|141394051|SUPERIORITY||unstandardized beta|-0.83|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic and income and are adjusted for multiple time points.||||||<0.001
70946922|NCT05178979|141394052|SUPERIORITY|Models control for clinic, income, years living with HIV and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Wald Chi-square|25.27|||<|0.001|TWO_SIDED||||||Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||<0.001
71130013|NCT02951429|141764514|SUPERIORITY||Difference (95% CI)|0.94||||0.755|TWO_SIDED|95.0|0.62|1.41|||Log Rank|||||1.41|0.62|0.7550
71130014|NCT02951429|141764515|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.9174|TWO_SIDED|95.0|0.65|1.61|||Log Rank|||||1.61|0.65|0.9174
71130015|NCT02951429|141764516|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.7748|TWO_SIDED|95.0|0.7|1.62|||Log Rank|||||1.62|0.70|0.7748
71130016|NCT02951429|141764517|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.4258|TWO_SIDED|95.0|0.38|1.5|||Log Rank|||||1.50|0.38|0.4258
71130017|NCT02951429|141764519|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.3161|TWO_SIDED|95.0|0.31|1.47|||Log Rank|||||1.47|0.31|0.3161
71130018|NCT02951429|141764529|SUPERIORITY||Difference in mean change from baseline|-206.59||||0.5646|TWO_SIDED|95.0|-920.03|506.85|||Linear Mixed Effects Model|||||506.85|-920.03|0.5646
71130019|NCT02951429|141764530|SUPERIORITY||Median Difference (Final Values)|-3.33||||0.5255|TWO_SIDED|95.0|-9.98|2.36|||ANCOVA|Difference in mean change in total score: -4.22||||2.36|-9.98|0.5255
71130020|NCT02951429|141764531|SUPERIORITY||Median Difference (Final Values)|-6.0||||0.4263|TWO_SIDED|95.0|-18.0|6.0|||ANCOVA|Difference in mean change in total score: -5.07||||6.00|-18.00|0.4263
71130021|NCT01620528|141764537|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71130022|NCT01620528|141764537|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71130023|NCT01620528|141764538|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71130024|NCT01620528|141764538|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71130025|NCT01620528|141764539|SUPERIORITY||Difference in LS Mean Change|-0.65|STANDARD_ERROR_OF_MEAN|0.155|<|0.001|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 1 of 7.||||< 0.001
71130026|NCT01620528|141764539|SUPERIORITY||Difference in LS Mean Change|-1.3|STANDARD_ERROR_OF_MEAN|0.156|<|0.001|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 1 of 7.||||< 0.001
71130027|NCT01620528|141764540|SUPERIORITY||Difference in LS Mean Change|-0.45|STANDARD_ERROR_OF_MEAN|0.074|<|0.001|TWO_SIDED|95.0|||||mixed-effects model|||Ranked secondary efficacy endpoint 2 of 7.||||< 0.001
71130028|NCT01620528|141764540|SUPERIORITY||Difference in Least Squares Mean|-1.32|STANDARD_ERROR_OF_MEAN|0.076|<|0.001|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 2 of 7.||||< 0.001
71130029|NCT01620528|141764541|SUPERIORITY||Difference in LS Mean Change|-0.16|STANDARD_ERROR_OF_MEAN|0.056||0.004|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 3 of 7.||||0.004
71130030|NCT01620528|141764541|SUPERIORITY||Least Squares Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.057|<|0.001|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 3 of 7.||||< 0.001
71130031|NCT01620528|141764542|SUPERIORITY||Difference in LS Mean Change|-0.01|STANDARD_ERROR_OF_MEAN|0.051||0.91|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 4 of 7.||||0.910
71130032|NCT01620528|141764542|SUPERIORITY||Difference in LS Mean Change|-0.26|STANDARD_ERROR_OF_MEAN|0.051|<|0.001|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 4 of 7.||||< 0.001
71130033|NCT01620528|141764543|SUPERIORITY||Difference in LS Mean Change|-0.07|STANDARD_ERROR_OF_MEAN|0.056||0.185|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 5 of 7.||||0.185
71130034|NCT01620528|141764543|SUPERIORITY||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.057|<|0.001|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 5 of 7.||||< 0.001
71130035|NCT01620528|141764544|SUPERIORITY||Difference in LS Mean Change|-0.09|STANDARD_ERROR_OF_MEAN|0.065||0.144|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 6 of 7.||||0.144
71130036|NCT01620528|141764544|SUPERIORITY||Difference in LS Mean Change|-0.2|STANDARD_ERROR_OF_MEAN|0.067||0.003|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 6 of 7.||||0.003
71130037|NCT01620528|141764545|SUPERIORITY||Difference in LS Mean Change|0.03|STANDARD_ERROR_OF_MEAN|0.037||0.424|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 7 of 7.||||0.424
71130038|NCT01620528|141764545|SUPERIORITY||Difference in LS Mean Change|-0.12|STANDARD_ERROR_OF_MEAN|0.038||0.002|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 7 of 7.||||0.002
71130039|NCT01620528|141764546|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71130040|NCT01620528|141764546|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
70859178|NCT03569293|141204863|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|13.0|||<|0.001|TWO_SIDED|95.0|8.1|17.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||17.8|8.1|<0.001
70859179|NCT03569293|141204864|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|-25.2|||<|0.001|TWO_SIDED|95.0|-30.3|-20.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||-20.1|-30.3|<0.001
70859180|NCT03569293|141204864|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|-24.1|||<|0.001|TWO_SIDED|95.0|-29.3|-18.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||-18.9|-29.3|<0.001
70859181|NCT03569293|141204865|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|52.9|||<|0.001|TWO_SIDED|95.0|45.2|60.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||60.6|45.2|<0.001
70859182|NCT03569293|141204865|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|41.8|||<|0.001|TWO_SIDED|95.0|33.9|49.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||49.7|33.9|<0.001
70946923|NCT05178979|141394052|SUPERIORITY||unstandardized beta|-0.26|STANDARD_ERROR_OF_MEAN|0.16||0.1|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is the 6-month follow-up.|Regression, Linear|Models control for clinic, income, years living with HIV and are adjusted for multiple time points.||||||0.10
70946924|NCT05178979|141394052|SUPERIORITY||unstandardized beta|0.08|STANDARD_ERROR_OF_MEAN|0.14||0.54|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is the 12-month follow-up.|Regression, Linear|Models control for clinic, income, years living with HIV and are adjusted for multiple time points||||||0.54
71130041|NCT01620528|141764547|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
70859183|NCT03569293|141204866|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|48.6|||<|0.001|TWO_SIDED|95.0|41.0|56.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||56.1|41.0|<0.001
70859184|NCT03569293|141204866|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|38.7|||<|0.001|TWO_SIDED|95.0|30.9|46.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||46.5|30.9|<0.001
70946925|NCT05178979|141394053|SUPERIORITY|Models control for clinic, gender, AUDIT score and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Wald Chi-square|36.04|||<|0.001|TWO_SIDED|||||Models control for clinic, gender, AUDIT score and are adjusted for multiple time points.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||<0.001
70946926|NCT05178979|141394053|SUPERIORITY||unstandardized beta|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.97|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, gender, AUDIT score and are adjusted for multiple time points.||||||0.97
70946927|NCT05178979|141394053|SUPERIORITY||unstandardized beta|-0.29|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, gender, AUDIT score and are adjusted for multiple time points.||||||<0.001
70946928|NCT05178979|141394054|SUPERIORITY||Wald Chi-square|9.46||||0.01|TWO_SIDED|||||Models control for clinic, gender, years living with HIV, AUDIT score and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.01
71130042|NCT01620528|141764547|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71130043|NCT01620528|141764548|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71130044|NCT01620528|141764548|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71130045|NCT01620528|141764549|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71130046|NCT01620528|141764549|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71130047|NCT01620528|141764550|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
70859185|NCT03569293|141204867|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|52.9|||<|0.001|TWO_SIDED|95.0|45.4|60.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||60.3|45.4|<0.001
70859186|NCT03569293|141204867|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|38.3|||<|0.001|TWO_SIDED|95.0|30.4|46.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||46.2|30.4|<0.001
70859187|NCT03569293|141204868|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|52.5|||<|0.001|TWO_SIDED|95.0|44.7|60.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||60.4|44.7|<0.001
70859188|NCT03569293|141204868|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|42.7|||<|0.001|TWO_SIDED|95.0|34.4|50.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||50.9|34.4|<0.001
70859189|NCT03569293|141204869|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|53.1|||<|0.001|TWO_SIDED|95.0|44.9|61.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||61.3|44.9|<0.001
70859190|NCT03569293|141204869|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|44.7|||<|0.001|TWO_SIDED|95.0|36.2|53.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||53.2|36.2|<0.001
70859191|NCT03569293|141204870|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|25.3|||<|0.001|TWO_SIDED|95.0|20.0|30.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||30.6|20.0|<0.001
70859192|NCT03569293|141204870|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|15.0|||<|0.001|TWO_SIDED|95.0|10.4|19.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||19.6|10.4|<0.001
70859193|NCT03569293|141204871|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes only.|Least Squares (LS) Mean Difference|-45.98|STANDARD_ERROR_OF_MEAN|6.549|<|0.001|TWO_SIDED|95.0|-58.82|-33.15|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-33.15|-58.82|<0.001
70946929|NCT05178979|141394054|SUPERIORITY||unstandardized beta|0.03|STANDARD_ERROR_OF_MEAN|0.12||0.81|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, gender, years living with HIV, AUDIT score and are adjusted for multiple time points.||||||0.81
71130048|NCT01620528|141764550|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71130049|NCT01620528|141764551|SUPERIORITY|||||||0.103|||||||Regression, Logistic|||||||0.103
71130050|NCT01620528|141764551|SUPERIORITY|||||||0.023|||||||Regression, Logistic|||||||0.023
71130051|NCT01620528|141764552|SUPERIORITY|||||||0.031|||||||Regression, Logistic|||||||0.031
71130052|NCT01620528|141764552|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71130053|NCT01620528|141764553|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71130054|NCT01620528|141764553|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71130055|NCT01620528|141764554|SUPERIORITY|||||||0.005|||||||Regression, Logistic|||||||0.005
71130056|NCT01620528|141764554|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71130057|NCT01620528|141764555|SUPERIORITY|||||||0.008|||||||Regression, Logistic|||||||0.008
70872051|NCT02155608|141229483|SUPERIORITY|||||||0.005||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 8.12, df = 1/228.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||.005
70946930|NCT05178979|141394054|SUPERIORITY||unstandardized beta|-0.25|STANDARD_ERROR_OF_MEAN|0.13||0.04|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, gender, years living with HIV, AUDIT score and are adjusted for multiple time points.||||||0.04
70946931|NCT05178979|141394055|SUPERIORITY||Wald Chi-square|14.77|||<|0.001|TWO_SIDED|||||Models control for clinic, gender, years living with HIV and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||<0.001
71130058|NCT01620528|141764555|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71130059|NCT01620528|141764556|SUPERIORITY|||||||0.306|||||||Regression, Logistic|||||||0.306
71130060|NCT01620528|141764556|SUPERIORITY|||||||0.239|||||||Regression, Logistic|||||||0.239
71130061|NCT01620528|141764557|SUPERIORITY|||||||0.855|||||||Regression, Logistic|||||||0.855
71130062|NCT01620528|141764557|SUPERIORITY|||||||0.012|||||||Regression, Logistic|||||||0.012
71130063|NCT01620528|141764558|SUPERIORITY|||||||0.01|||||||Regression, Logistic|||||||0.010
71130064|NCT01620528|141764558|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71130065|NCT01620528|141764559|SUPERIORITY|||||||0.061|||||||Regression, Logistic|||||||0.061
71130066|NCT01620528|141764559|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71130067|NCT01620528|141764560|SUPERIORITY|||||||0.126|||||||Regression, Logistic|||||||0.126
71130068|NCT01620528|141764560|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71130069|NCT01620528|141764561|SUPERIORITY||LS Mean of Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|97.5|-0.65|-0.34|||mixed-effects model|||||-0.34|-0.65|< 0.001
71130070|NCT01620528|141764561|SUPERIORITY||LS Mean of Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|97.5|-0.81|-0.49|||mixed-effects model|||||-0.49|-0.81|< 0.001
71130071|NCT01620528|141764562|SUPERIORITY||LS Mean of Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.067|<|0.001|TWO_SIDED|97.5|-0.79|-0.49|||mixed-effects model|||||-0.49|-0.79|< 0.001
71130072|NCT01620528|141764562|SUPERIORITY||LS Mean of Difference|-1.36|STANDARD_ERROR_OF_MEAN|0.068|<|0.001|TWO_SIDED|97.5|-1.51|-1.2|||mixed-effects model|||||-1.20|-1.51|< 0.001
71130073|NCT01620528|141764563|SUPERIORITY||LS Mean of Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.068|<|0.001|TWO_SIDED|97.5|-0.83|-0.53|||mixed-effects model|||||-0.53|-0.83|< 0.001
71130074|NCT01620528|141764563|SUPERIORITY||LS Mean of Difference|-1.39|STANDARD_ERROR_OF_MEAN|0.069|<|0.001|TWO_SIDED|97.5|-1.54|-1.23|||mixed-effects model|||||-1.23|-1.54|< 0.001
71130075|NCT01620528|141764564|SUPERIORITY||LS Mean of Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.81|-0.49|||mixed-effects model|||||-0.49|-0.81|< 0.001
71130076|NCT01620528|141764564|SUPERIORITY||LS Mean of Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.072|<|0.001|TWO_SIDED|97.5|-1.49|-1.16|||mixed-effects model|||||-1.16|-1.49|< 0.001
71130077|NCT01620528|141764565|SUPERIORITY||LS Mean of Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.75|-0.43|||mixed-effects model|||||-0.43|-0.75|< 0.001
71130078|NCT01620528|141764565|SUPERIORITY||LS Mean of Difference|-1.41|STANDARD_ERROR_OF_MEAN|0.072|<|0.001|TWO_SIDED|97.5|-1.58|-1.25|||mixed-effects model|||||-1.25|-1.58|< 0.001
71130079|NCT01620528|141764566|SUPERIORITY||LS Mean of Difference|-24.07|STANDARD_ERROR_OF_MEAN|3.288|<|0.001|TWO_SIDED|97.5|-31.45|-16.69|||mixed-effects model|||||-16.69|-31.45|< 0.001
71130080|NCT01620528|141764566|SUPERIORITY||LS Mean of Difference|-31.01|STANDARD_ERROR_OF_MEAN|3.299|<|0.001|TWO_SIDED|97.5|-38.41|-23.6|||mixed-effects model|||||-23.60|-38.41|< 0.001
71130081|NCT01620528|141764567|SUPERIORITY||LS Mean of Difference|-30.79|STANDARD_ERROR_OF_MEAN|3.107||-30.79|TWO_SIDED|97.5|-37.77|-23.82|||mixed-effects model|||||-23.82|-37.77|-30.79
71130082|NCT01620528|141764567|SUPERIORITY||LS Mean of Difference|-63.78|STANDARD_ERROR_OF_MEAN|3.148|<|0.001|TWO_SIDED|97.5|-70.85|-56.71|||mixed-effects model|||||-56.71|-70.85|< 0.001
71130083|NCT01620528|141764568|SUPERIORITY||LS Mean of Difference|-32.21|STANDARD_ERROR_OF_MEAN|3.177|<|0.001|TWO_SIDED|97.5|-39.35|-25.08|||mixed-effects model|||||-25.08|-39.35|< 0.001
70859194|NCT03569293|141204871|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-36.74|||<|0.001|TWO_SIDED|95.0|-49.66|-23.81|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-23.81|-49.66|<0.001
70859195|NCT03569293|141204872|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-47.03|STANDARD_ERROR_OF_MEAN|2.716|<|0.001|TWO_SIDED|95.0|-52.37|-41.7|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-41.70|-52.37|<0.001
70859196|NCT03569293|141204872|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-39.53|STANDARD_ERROR_OF_MEAN|2.738|<|0.001|TWO_SIDED|95.0|-44.91|-34.15|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-34.15|-44.91|<0.001
70859197|NCT03569293|141204873|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|58.6|||<|0.001|TWO_SIDED|95.0|51.9|65.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||65.3|51.9|<0.001
70859198|NCT03569293|141204873|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|52.3|||<|0.001|TWO_SIDED|95.0|45.2|59.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||59.4|45.2|<0.001
70859199|NCT03569293|141204874|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|53.2|||<|0.001|TWO_SIDED|95.0|45.9|60.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||60.5|45.9|<0.001
71130084|NCT01620528|141764568|SUPERIORITY||LS Mean of Difference|-64.94|STANDARD_ERROR_OF_MEAN|3.23|<|0.001|TWO_SIDED|97.5|-72.19|-57.68|||mixed-effects model|||||-57.68|-72.19|< 0.001
71130085|NCT01620528|141764569|SUPERIORITY||LS Mean of Difference|-29.94|STANDARD_ERROR_OF_MEAN|3.272|<|0.001|TWO_SIDED|97.5|-37.28|-22.59|||mixed-effects model|||||-22.59|-37.28|< 0.001
71130086|NCT01620528|141764569|SUPERIORITY||LS Mean of Difference|-61.9|STANDARD_ERROR_OF_MEAN|3.356|<|0.001|TWO_SIDED|97.5|-69.44|-54.36|||mixed-effects model|||||-54.36|-69.44|< 0.001
71130087|NCT01620528|141764570|SUPERIORITY||LS Mean of Difference|-28.63|STANDARD_ERROR_OF_MEAN|3.26|<|0.001|TWO_SIDED|97.5|-35.96|-21.31|||mixed-effects model|||||-21.31|-35.96|< 0.001
71130088|NCT01620528|141764570|SUPERIORITY||LS Mean of Difference|-66.5|STANDARD_ERROR_OF_MEAN|3.321|<|0.001|TWO_SIDED|97.5|-73.95|-59.04|||mixed-effects model|||||-59.04|-73.95|< 0.001
71130089|NCT01620528|141764571|SUPERIORITY||LS Mean of Difference|-21.39|STANDARD_ERROR_OF_MEAN|3.479|<|0.001|TWO_SIDED|97.5|-29.2|-13.57|||mixed-effects model|||||-13.57|-29.20|< 0.001
71130090|NCT01620528|141764571|SUPERIORITY||LS Mean of Difference|-60.78|STANDARD_ERROR_OF_MEAN|3.557|<|0.001|TWO_SIDED|97.5|-68.77|-52.79|||mixed-effects model|||||-52.79|-68.77|< 0.001
71130091|NCT01620528|141764572|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.036||0.111|TWO_SIDED|97.5|-0.14|0.02|||mixed-effects model|||||0.02|-0.14|0.111
70859200|NCT03569293|141204874|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|46.7|||<|0.001|TWO_SIDED|95.0|39.0|54.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||54.4|39.0|<0.001
70859201|NCT03569293|141204875|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-40.39|STANDARD_ERROR_OF_MEAN|2.732|<|0.001|TWO_SIDED|95.0|-45.75|-35.03|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-35.03|-45.75|<0.001
70859202|NCT03569293|141204875|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-33.03|STANDARD_ERROR_OF_MEAN|2.758|<|0.001|TWO_SIDED|95.0|-38.44|-27.61|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-27.61|-38.44|<0.001
70859203|NCT03569293|141204876|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|34.9|||<|0.001|TWO_SIDED|95.0|24.8|45.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||45.1|24.8|<0.001
70859204|NCT03569293|141204876|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|31.5|||<|0.001|TWO_SIDED|95.0|21.4|41.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||41.6|21.4|<0.001
70859205|NCT03569293|141204877|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|37.3|||<|0.001|TWO_SIDED|95.0|30.8|43.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||43.8|30.8|<0.001
70859206|NCT03569293|141204877|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|25.9|||<|0.001|TWO_SIDED|95.0|19.7|32.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||32.1|19.7|<0.001
70859207|NCT03569293|141204878|SUPERIORITY||Adjusted Response Rate Difference|66.6|||<|0.001|TWO_SIDED|95.0|53.8|79.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||79.4|53.8|<0.001
70946932|NCT05178979|141394055|SUPERIORITY||unstandardized beta|0.12|STANDARD_ERROR_OF_MEAN|0.16||0.45|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, gender, years living with HIV and are adjusted for multiple time points.||||||0.45
71130092|NCT01620528|141764572|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.036||0.008|TWO_SIDED|97.5|-0.18|-0.01|||mixed-effects model|||||-0.01|-0.18|0.008
70859208|NCT03569293|141204878|SUPERIORITY||Adjusted Response Rate Difference|62.0|||<|0.001|TWO_SIDED|95.0|48.6|75.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||75.4|48.6|<0.001
71130093|NCT01620528|141764573|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.045||0.092|TWO_SIDED|97.5|-0.18|0.02|||mixed-effects model|||||0.02|-0.18|0.092
71130094|NCT01620528|141764573|SUPERIORITY||LS Mean of Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.045|<|0.001|TWO_SIDED|97.5|-0.28|-0.08|||mixed-effects model|||||-0.08|-0.28|< 0.001
71130095|NCT01620528|141764574|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05||0.017|TWO_SIDED|97.5|-0.23|-0.01|||mixed-effects model|||||-0.01|-0.23|0.017
71130096|NCT01620528|141764574|SUPERIORITY||LS Mean of Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|97.5|-0.41|-0.18|||mixed-effects model|||||-0.18|-0.41|< 0.001
71130097|NCT01620528|141764575|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.053|<|0.001|TWO_SIDED|97.5|-0.31|-0.07|||mixed-effects model|||||-0.07|-0.31|< 0.001
70859209|NCT03569293|141204879|SUPERIORITY||Adjusted Response Rate Difference|57.4|||<|0.001|TWO_SIDED|95.0|44.6|70.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||70.2|44.6|<0.001
70859210|NCT03569293|141204879|SUPERIORITY||Adjusted Response Rate Difference|39.1|||<|0.001|TWO_SIDED|95.0|25.6|52.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||52.6|25.6|<0.001
70859211|NCT03569293|141204880|SUPERIORITY||Adjusted Response Rate Difference|46.6|||<|0.001|TWO_SIDED|95.0|32.6|60.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||60.6|32.6|<0.001
70859212|NCT03569293|141204880|SUPERIORITY||Adjusted Response Rate Difference|38.7|||<|0.001|TWO_SIDED|95.0|24.3|53.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||53.1|24.3|<0.001
70859213|NCT03569293|141204881|SUPERIORITY||Adjusted Response Rate Difference|63.9|||<|0.001|TWO_SIDED|95.0|51.8|75.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||75.9|51.8|<0.001
70859214|NCT03569293|141204881|SUPERIORITY||Adjusted Response Rate Difference|43.8|||<|0.001|TWO_SIDED|95.0|30.9|56.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||56.7|30.9|<0.001
70859215|NCT03569293|141204882|SUPERIORITY||Adjusted Response Rate Difference|54.7|||<|0.001|TWO_SIDED|95.0|41.7|67.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||67.8|41.7|<0.001
70859216|NCT03569293|141204882|SUPERIORITY||Adjusted Response Rate Difference|45.2|||<|0.001|TWO_SIDED|95.0|32.0|58.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||58.3|32.0|<0.001
70859217|NCT03569293|141204883|SUPERIORITY||Adjusted Response Rate Difference|47.1|||<|0.001|TWO_SIDED|95.0|34.0|60.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||60.2|34.0|<0.001
71130098|NCT01620528|141764575|SUPERIORITY||LS Mean of Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.054|<|0.001|TWO_SIDED|97.5|-0.51|-0.27|||mixed-effects model|||||-0.27|-0.51|< 0.001
70859218|NCT03569293|141204883|SUPERIORITY||Adjusted Response Rate Difference|35.9|||<|0.001|TWO_SIDED|95.0|23.2|48.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||48.6|23.2|<0.001
70859219|NCT03569293|141204884|SUPERIORITY||Adjusted Response Rate Difference|21.0|||<|0.001|TWO_SIDED|95.0|11.0|31.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||31.1|11.0|<0.001
70859220|NCT03569293|141204884|SUPERIORITY||Adjusted Response Rate Difference|9.4||||0.008|TWO_SIDED|95.0|2.5|16.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||16.4|2.5|0.008
70859221|NCT03569293|141204885|SUPERIORITY||Adjusted Response Rate Difference|11.0||||0.015|TWO_SIDED|95.0|2.1|19.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||19.9|2.1|0.015
70859222|NCT03569293|141204885|SUPERIORITY||Adjusted Response Rate Difference|6.5||||0.086|TWO_SIDED|95.0|-0.9|13.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||13.9|-0.9|0.086
70859223|NCT03569293|141204886|SUPERIORITY||Adjusted Response Rate Difference|10.8||||0.045|TWO_SIDED|95.0|0.2|21.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||21.4|0.2|0.045
70859224|NCT03569293|141204886|SUPERIORITY||Adjusted Response Rate Difference|11.0||||0.04|TWO_SIDED|95.0|0.5|21.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||21.5|0.5|0.040
70859225|NCT03569293|141204887|SUPERIORITY||Adjusted Response Rate Difference|-22.1|||<|0.001|TWO_SIDED|95.0|-32.6|-11.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||-11.5|-32.6|<0.001
70859226|NCT03569293|141204887|SUPERIORITY||Adjusted Response Rate Difference|-22.1|||<|0.001|TWO_SIDED|95.0|-32.7|-11.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||-11.5|-32.7|<0.001
70859227|NCT03569293|141204888|SUPERIORITY||Adjusted Response Rate Difference|53.6|||<|0.001|TWO_SIDED|95.0|37.7|69.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||69.4|37.7|<0.001
70859228|NCT03569293|141204888|SUPERIORITY||Adjusted Response Rate Difference|34.8|||<|0.001|TWO_SIDED|95.0|18.1|51.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||51.4|18.1|<0.001
70859229|NCT03569293|141204889|SUPERIORITY||Adjusted Response Rate Difference|56.6|||<|0.001|TWO_SIDED|95.0|42.0|71.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||71.1|42.0|<0.001
70859230|NCT03569293|141204889|SUPERIORITY||Adjusted Response Rate Difference|32.5|||<|0.001|TWO_SIDED|95.0|16.9|48.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||48.1|16.9|<0.001
71130099|NCT01620528|141764576|SUPERIORITY||LS Mean of Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.053||0.004|TWO_SIDED|97.5|-0.27|-0.03|||mixed-effects model|||||-0.03|-0.27|0.004
71130100|NCT01620528|141764576|SUPERIORITY||LS Mean of Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.054|<|0.001|TWO_SIDED|97.5|-0.52|-0.27|||mixed-effects model|||||-0.27|-0.52|< 0.001
71130101|NCT01620528|141764577|SUPERIORITY||LS Mean of Difference|-6.23|STANDARD_ERROR_OF_MEAN|2.748||0.024|TWO_SIDED|97.5|-12.4|-0.06|||mixed-effects model|||||-0.06|-12.40|0.024
70859231|NCT03569293|141204890|SUPERIORITY||Adjusted Response Rate Difference|50.9|||<|0.001|TWO_SIDED|95.0|35.1|66.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||66.7|35.1|<0.001
70859232|NCT03569293|141204890|SUPERIORITY||Adjusted Response Rate Difference|35.7|||<|0.001|TWO_SIDED|95.0|18.8|52.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||52.6|18.8|<0.001
70859233|NCT03569293|141204891|SUPERIORITY||Adjusted Response Rate Difference|54.4|||<|0.001|TWO_SIDED|95.0|37.4|71.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||71.3|37.4|<0.001
70859234|NCT03569293|141204891|SUPERIORITY||Adjusted Response Rate Difference|38.1|||<|0.001|TWO_SIDED|95.0|19.8|56.4|||Chi-squared, Corrected|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||56.4|19.8|<0.001
70859235|NCT03569293|141204892|SUPERIORITY||Adjusted Response Rate Difference|51.2|||<|0.001|TWO_SIDED|95.0|33.3|69.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||69.1|33.3|<0.001
70859236|NCT03569293|141204892|SUPERIORITY||Adjusted Response Rate Difference|28.1||||0.006|TWO_SIDED|95.0|8.0|48.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||48.2|8.0|0.006
70946933|NCT05178979|141394055|SUPERIORITY||unstandardized beta|-0.43|STANDARD_ERROR_OF_MEAN|0.18||0.02|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, gender, years living with HIV and are adjusted for multiple time points.||||||0.02
70859237|NCT03569293|141204893|SUPERIORITY||Adjusted Response Rate Difference|31.2|||<|0.001|TWO_SIDED|95.0|19.9|42.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||42.5|19.9|<0.001
71130102|NCT01620528|141764577|SUPERIORITY||LS Mean of Difference|-7.72|STANDARD_ERROR_OF_MEAN|2.756||0.005|TWO_SIDED|97.5|-13.9|-1.53|||mixed-effects model|||||-1.53|-13.90|0.005
71130103|NCT01620528|141764578|SUPERIORITY||LS Mean of Difference|-5.69|STANDARD_ERROR_OF_MEAN|3.226||0.078|TWO_SIDED|97.5|-12.93|1.56|||mixed-effects model|||||1.56|-12.93|0.078
71130104|NCT01620528|141764578|SUPERIORITY||LS Mean of Difference|-13.72|STANDARD_ERROR_OF_MEAN|3.249|<|0.001|TWO_SIDED|97.5|-21.01|-6.42|||mixed-effects model|||||-6.42|-21.01|< 0.001
71130105|NCT01620528|141764579|SUPERIORITY||LS Mean of Difference|-8.47|STANDARD_ERROR_OF_MEAN|3.475||0.015|TWO_SIDED|97.5|-16.27|-0.66|||mixed-effects model|||||-0.66|-16.27|0.015
71130106|NCT01620528|141764579|SUPERIORITY||LS Mean of Difference|-22.49|STANDARD_ERROR_OF_MEAN|3.514|<|0.001|TWO_SIDED|97.5|-30.38|-14.6|||mixed-effects model|||||-14.60|-30.38|< 0.001
71130107|NCT01620528|141764580|SUPERIORITY||LS Mean of Difference|-14.11|STANDARD_ERROR_OF_MEAN|3.673|<|0.001|TWO_SIDED|97.5|-22.36|-5.87|||mixed-effects model|||||-5.87|-22.36|< 0.001
71130108|NCT01620528|141764580|SUPERIORITY||LS Mean of Difference|-30.41|STANDARD_ERROR_OF_MEAN|3.729|<|0.001|TWO_SIDED|97.5|-38.78|-22.04|||mixed-effects model|||||-22.04|-38.78|< 0.001
71130109|NCT01620528|141764581|SUPERIORITY||LS Mean of Difference|-11.55|STANDARD_ERROR_OF_MEAN|3.736||0.002|TWO_SIDED|97.5|-19.94|-3.16|||mixed-effects model|||||-3.16|-19.94|0.002
71130110|NCT01620528|141764581|SUPERIORITY||LS Mean of Difference|-29.68|STANDARD_ERROR_OF_MEAN|3.788|<|0.001|TWO_SIDED|97.5|-38.19|-21.18|||mixed-effects model|||||-21.18|-38.19|< 0.001
71130111|NCT01620528|141764582|SUPERIORITY||LS Mean of Difference|-12.37|STANDARD_ERROR_OF_MEAN|3.805||0.001|TWO_SIDED|97.5|-20.92|-3.83|||mixed-effects model|||||-3.83|-20.92|0.001
70859238|NCT03569293|141204893|SUPERIORITY||Adjusted Response Rate Difference|15.8||||0.001|TWO_SIDED|95.0|6.9|24.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||24.6|6.9|0.001
70859239|NCT03569293|141204894|SUPERIORITY||LS Mean Difference|-42.42|||<|0.001|TWO_SIDED|95.0|-56.16|-28.68|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-28.68|-56.16|<0.001
70859240|NCT03569293|141204894|SUPERIORITY||LS Mean Difference|-33.88|||<|0.001|TWO_SIDED|95.0|-47.76|-19.99|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-19.99|-47.76|<0.001
70859241|NCT03569293|141204895|SUPERIORITY||LS Mean Difference|-41.84|||<|0.001|TWO_SIDED|95.0|-52.09|-31.58|||Mixed Effect Model Repeated Measurement|Mixed-Effect Model Repeat Measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-31.58|-52.09|<0.001
70859242|NCT03569293|141204895|SUPERIORITY||LS Mean Difference|-37.84|||<|0.001|TWO_SIDED|95.0|-48.17|-27.52|||Mixed Effect Model Repeated Measurement|Mixed-Effect Model Repeat Measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-27.52|-48.17|<0.001
70859243|NCT03569293|141204896|SUPERIORITY||Adjusted Response Rate Difference|54.8|||<|0.001|TWO_SIDED|95.0|40.3|69.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||69.4|40.3|<0.001
70859244|NCT03569293|141204896|SUPERIORITY||Adjusted Response Rate Difference|50.0|||<|0.001|TWO_SIDED|95.0|34.8|65.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||65.3|34.8|<0.001
70946934|NCT05178979|141394056|SUPERIORITY||Wald Chi-square|11.06||||0.004|TWO_SIDED|||||Models control for clinic, AUDIT score, food insecurity and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.004
70946935|NCT05178979|141394056|SUPERIORITY||unstandardized beta|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.35|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, AUDIT score, food insecurity and are adjusted for multiple time points.||||||0.35
70946936|NCT05178979|141394056|SUPERIORITY||unstandardized beta|-0.13|STANDARD_ERROR_OF_MEAN|0.06||0.04|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, AUDIT score, food insecurity and are adjusted for multiple time points.||||||0.04
70859245|NCT03569293|141204897|SUPERIORITY||Adjusted Response Rate Difference|45.1|||<|0.001|TWO_SIDED|95.0|21.0|69.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||69.2|21.0|<0.001
70859246|NCT03569293|141204897|SUPERIORITY||Adjusted Response Rate Difference|49.6|||<|0.001|TWO_SIDED|95.0|26.7|72.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||72.5|26.7|<0.001
70859247|NCT03569293|141204898|SUPERIORITY||LS Mean Difference|-38.92|||<|0.001|TWO_SIDED|95.0|-49.54|-28.31|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category|Difference = Upadacitinib - Placebo|||-28.31|-49.54|<0.001
70946937|NCT05178979|141394057|SUPERIORITY||Wald Chi-square|2.84||||0.24|TWO_SIDED|||||Models control for clinic, gender, years living with HIV, travel time to clinic and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.24
70859248|NCT03569293|141204898|SUPERIORITY||LS Mean Difference|-32.7|||<|0.001|TWO_SIDED|95.0|-43.44|-21.96|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category|Difference = Upadacitinib - Placebo|||-21.96|-43.44|<0.001
70859249|NCT03569293|141204899|SUPERIORITY||Adjusted Response Rate Difference|51.7|||<|0.001|TWO_SIDED|95.0|31.7|71.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||71.8|31.7|<0.001
70859250|NCT03569293|141204899|SUPERIORITY||Adjusted Response Rate Difference|44.7|||<|0.001|TWO_SIDED|95.0|26.7|62.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||62.8|26.7|<0.001
70859251|NCT03569293|141204900|SUPERIORITY||Adjusted Response Rate Difference|25.1||||0.006|TWO_SIDED|95.0|7.3|43.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||43.0|7.3|0.006
70859252|NCT03569293|141204900|SUPERIORITY||Adjusted Response Rate Difference|15.8||||0.093|TWO_SIDED|95.0|-2.6|34.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||34.2|-2.6|0.093
70859253|NCT05803603|141204924|SUPERIORITY||Odds Ratio (OR)|2.0||||0.125|TWO_SIDED|95.0|0.37|10.92|||McNemar|||We recruited 8 homeless individuals and followed them for 12 months. 4 individuals (50%) were housed at 6 months and 3 (37.5) were housed at 12 months.|See results above|10.92|.37|.125
70859254|NCT03553836|141204925|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.00046|TWO_SIDED|95.0|0.45|0.82||One-sided p-value based on log-rank test stratified by melanoma T Stage (T3b, T4a, T4b).|Log Rank||Hazard Ratio based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by melanoma T Stage (T3b, T4a, T4b).|||0.82|0.45|0.00046
70946938|NCT05178979|141394057|SUPERIORITY||unstandardized beta|0.02|STANDARD_ERROR_OF_MEAN|0.17||0.92|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, gender, years living with HIV, travel time to clinic and are adjusted for multiple time points.||||||0.92
70946939|NCT05178979|141394057|SUPERIORITY||unstandardized beta|-0.21|STANDARD_ERROR_OF_MEAN|0.16||0.21|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, gender, years living with HIV, travel time to clinic and are adjusted for multiple time points.||||||0.21
71130112|NCT01620528|141764582|SUPERIORITY||LS Mean of Difference|-29.97|STANDARD_ERROR_OF_MEAN|3.868|<|0.001|TWO_SIDED|97.5|-38.66|-21.28|||mixed-effects model|||||-21.28|-38.66|< 0.001
70859255|NCT03553836|141204928|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in Percentage|4.1|||||TWO_SIDED|95.0|1.0|7.3||||||||7.3|1.0|
70859256|NCT03553836|141204929|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in percentage|12.9|||||TWO_SIDED|95.0|9.1|16.9||||||||16.9|9.1|
70859257|NCT01041495|141204934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.869||||0.869|TWO_SIDED|95.0||||P values below 0.05 were considered statistically significant|t-test, 2 sided|||||||.869
71130113|NCT01620528|141764583|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.052||0.038|TWO_SIDED|97.5|-0.22|0.01|||mixed-effects model|||||0.01|-0.22|0.038
71130114|NCT01620528|141764583|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.053||0.488|TWO_SIDED|97.5|-0.16|0.08|||mixed-effects model|||||0.08|-0.16|0.488
71130115|NCT01620528|141764584|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.06||0.252|TWO_SIDED|97.5|-0.2|0.07|||mixed-effects model|||||0.07|-0.20|0.252
71130116|NCT01620528|141764584|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.061||0.058|TWO_SIDED|97.5|-0.25|0.02|||mixed-effects model|||||0.02|-0.25|0.058
70946940|NCT01721746|141394065|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.68|1.08|||||From stratified cox proportional hazard model with treatment group as a single covariate, stratified by BRAF status, prior anti-CTLA-4 benefit, and PD-L1 status (IVRS source)|Hazard Ratio is Nivolumab 3 mg/kg (IV) over Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)||1.08|0.68|
71130117|NCT01620528|141764585|SUPERIORITY||LS Mean of Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.069||0.009|TWO_SIDED|97.5|-0.34|-0.03|||mixed-effects model|||||-0.03|-0.34|0.009
71130118|NCT01620528|141764585|SUPERIORITY||LS Mean of Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.5|-0.18|||mixed-effects model|||||-0.18|-0.50|< 0.001
71130119|NCT01620528|141764586|SUPERIORITY||LS Mean of Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.073||0.06|TWO_SIDED|97.5|-0.3|0.03|||mixed-effects model|||||0.03|-0.30|0.060
71130120|NCT01620528|141764586|SUPERIORITY||LS Mean of Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.076|<|0.001|TWO_SIDED|97.5|-0.44|-0.1|||mixed-effects model|||||-0.10|-0.44|< 0.001
71130121|NCT01620528|141764587|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.074||0.118|TWO_SIDED|97.5|-0.28|0.05|||mixed-effects model|||||0.05|-0.28|0.118
71130122|NCT01620528|141764587|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.078|<|0.001|TWO_SIDED|97.5|-0.48|-0.13|||mixed-effects model|||||-0.13|-0.48|< 0.001
71130123|NCT01620528|141764588|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.044||0.313|TWO_SIDED|97.5|-0.14|0.05|||mixed-effects model|||||0.05|-0.14|0.313
71130124|NCT01620528|141764588|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.044||0.006|TWO_SIDED|97.5|-0.22|-0.02|||mixed-effects model|||||-0.02|-0.22|0.006
71130125|NCT01620528|141764589|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.047||0.519|TWO_SIDED|97.5|-0.13|0.07|||mixed-effects model|||||0.07|-0.13|0.519
71130126|NCT01620528|141764589|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.047|<|0.001|TWO_SIDED|97.5|-0.32|-0.11|||mixed-effects model|||||-0.11|-0.32|< 0.001
71130127|NCT01620528|141764590|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.053||0.037|TWO_SIDED|97.5|-0.23|0.01|||mixed-effects model|||||0.01|-0.23|0.037
71130128|NCT01620528|141764590|SUPERIORITY||LS Mean of Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.053|<|0.001|TWO_SIDED|97.5|-0.41|-0.17|||mixed-effects model|||||-0.17|-0.41|< 0.001
71130129|NCT01620528|141764591|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.053||0.2|TWO_SIDED|97.5|-0.19|0.05|||mixed-effects model|||||0.05|-0.19|0.200
71130130|NCT01620528|141764591|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.054|<|0.001|TWO_SIDED|97.5|-0.42|-0.18|||mixed-effects model|||||-0.18|-0.42|< 0.001
71130131|NCT01620528|141764592|SUPERIORITY||LS Mean of Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.094|<|0.001|TWO_SIDED|95.0|-0.72|-0.34|||ANOVA|||||-0.34|-0.72|< 0.001
71130132|NCT01620528|141764592|SUPERIORITY||LS Mean of Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.095|<|0.001|TWO_SIDED|95.0|-0.93|-0.56|||ANOVA|||||-0.56|-0.93|< 0.001
71130133|NCT01620528|141764593|SUPERIORITY||LS Mean of Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.098|<|0.001|TWO_SIDED|95.0|-0.58|-0.19|||ANOVA|||||-0.19|-0.58|< 0.001
71130134|NCT01620528|141764593|SUPERIORITY||LS Mean of Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-1.21|-0.82|||ANOVA|||||-0.82|-1.21|< 0.001
71130135|NCT01620528|141764594|SUPERIORITY||LS Mean of Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.101|<|0.001|TWO_SIDED|95.0|-0.81|-0.41|||ANOVA|||||-0.41|-0.81|< 0.001
71130136|NCT01620528|141764594|SUPERIORITY||LS Mean of Difference|-1.12|STANDARD_ERROR_OF_MEAN|0.102|<|0.001|TWO_SIDED|95.0|-1.32|-0.92|||ANOVA|||||-0.92|-1.32|< 0.001
71130137|NCT01620528|141764595|SUPERIORITY||LS Mean of Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.106|<|0.001|TWO_SIDED|95.0|-0.83|-0.42|||ANOVA|||||-0.42|-0.83|< 0.001
71130138|NCT01620528|141764595|SUPERIORITY||LS Mean of Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.107|<|0.001|TWO_SIDED|95.0|-1.47|-1.05|||ANOVA|||||-1.05|-1.47|< 0.001
70859258|NCT01041495|141204935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.0||||0.486|TWO_SIDED||||||t-test, 2 sided|||Visual Analogue Pain Scale (VAPS). The final visit VAPS at 8th week will be compared against baseline VAPS scores for both treatment groups||||.486
70859259|NCT01041495|141204935|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.486|TWO_SIDED||||||t-test, 1 sided|||||||.486
70859260|NCT01041495|141204936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|17.0||||0.869|TWO_SIDED||||||t-test, 2 sided||As above- this was the difference between the groups on mean avg, it was used here|||||.869
70859261|NCT01041495|141204936|SUPERIORITY||Mean Difference (Final Values)|17.0||||0.275|TWO_SIDED||||||t-test, 1 sided|||||||.275
70859262|NCT02882074|141204937|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.158|TWO_SIDED|95.0|-0.11|0.64|||Regression, Linear|||||0.64|-0.11|0.158
70946941|NCT01721746|141394066|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.1|0.78|1.36|||||Stratified Cox proportional hazard model.|Hazard Ratio is Nivolumab 3 mg/kg (IV) over Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)||1.36|0.78|
70946942|NCT01721746|141394067|SUPERIORITY||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.44|3.16||||||For \<5% PD-L1 expression. Ratio of Nivolumab over Investigator's Choice||3.16|0.44|
70859263|NCT02882074|141204938|SUPERIORITY||Ratio of geometric means|0.86||||0.388|TWO_SIDED|97.5|0.57|1.28||The significance criterion is p-value \< 0.025 (i.e. 0.05/2), corrected for multiple comparisons.|Mixed Models Analysis||Syndecan values were all log-transformed to meet the linearity requirement. Thus the treatment effect was presented as the ratio of geometric means.|||1.28|0.57|0.388
70946943|NCT01721746|141394067|SUPERIORITY||Odds Ratio (OR)|5.49|||||TWO_SIDED|95.0|1.92|19.08||||||For \>=5% PD-L1 expression. Ratio of Nivolumab over Investigator's Choice||19.08|1.92|
70946944|NCT01721746|141394068|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.5|1.01|||||From unstratified Cox proportional hazard model|PD-L1 Positive||1.01|0.50|
70946945|NCT01721746|141394069|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.75|1.41|||||From unstratified Cox proportional hazard model|PD-L1 Negative||1.41|0.75|
70946946|NCT04358068|141394077|SUPERIORITY|Participant specific durations were compared between randomized arms using a two-sided Wilcoxon test with a two-sided 5% type I error rate||||||0.51||||||Wilcoxon Test was not stratified by high/low risk because of the small number enrolled|Wilcoxon (Mann-Whitney)|||||||0.51
71130139|NCT01620528|141764596|SUPERIORITY||LS Mean of Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.111|<|0.001|TWO_SIDED|95.0|-0.91|-0.48|||ANOVA|||||-0.48|-0.91|< 0.001
71130140|NCT01620528|141764596|SUPERIORITY||LS Mean of Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.112|<|0.001|TWO_SIDED|95.0|-1.54|-1.1|||ANOVA|||||-1.10|-1.54|< 0.001
71130141|NCT01620528|141764597|SUPERIORITY||LS Mean of Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.122|<|0.001|TWO_SIDED|95.0|-0.96|-0.48|||ANOVA|||||-0.48|-0.96|< 0.001
71130142|NCT01620528|141764597|SUPERIORITY||LS Mean of Difference|-1.35|STANDARD_ERROR_OF_MEAN|0.123|<|0.001|TWO_SIDED|95.0|-1.59|-1.11|||ANOVA|||||-1.11|-1.59|< 0.001
71130143|NCT01620528|141764598|SUPERIORITY||LS Mean of Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.109||0.011|TWO_SIDED|95.0|-0.52|-0.03|||mixed-effects model|||||-0.03|-0.52|0.011
71130144|NCT01620528|141764598|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|97.5|-0.65|-0.16|||mixed-effects model|||||-0.16|-0.65|< 0.001
71130145|NCT01620528|141764599|SUPERIORITY||LS Mean of Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.137|<|0.001|TWO_SIDED|97.5|-0.77|-0.16|||mixed-effects model|||||-0.16|-0.77|<0.001
71130146|NCT01620528|141764599|SUPERIORITY||LS Mean of Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.138||-0.96|TWO_SIDED|97.5|-1.27|-0.65|||mixed-effects model|||||-0.65|-1.27|-0.96
71130147|NCT01620528|141764600|SUPERIORITY||LS Mean of Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.163|<|0.001|TWO_SIDED|97.5|-1.17|-0.44|||mixed-effects model|||||-0.44|-1.17|< 0.001
71130148|NCT01620528|141764600|SUPERIORITY||LS Mean of Difference|-1.61|STANDARD_ERROR_OF_MEAN|0.165|<|0.001|TWO_SIDED|97.5|-1.98|-1.24|||mixed-effects model|||||-1.24|-1.98|< 0.001
71130149|NCT01620528|141764601|SUPERIORITY||LS Mean of Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.167|<|0.001|TWO_SIDED|97.5|-1.05|-0.3|||mixed-effects model|||||-0.30|-1.05|< 0.001
71130150|NCT01620528|141764601|SUPERIORITY||LS Mean of Difference|-1.61|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|97.5|-1.99|-1.23|||mixed-effects model|||||-1.23|-1.99|< 0.001
71130151|NCT01620528|141764602|SUPERIORITY||LS Mean of Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.176|<|0.001|TWO_SIDED|97.5|-1.04|-0.25|||mixed-effects model|||||-0.25|-1.04|< 0.001
71130152|NCT01620528|141764602|SUPERIORITY||LS Mean of Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.179|<|0.001|TWO_SIDED|97.5|-2.0|-1.2|||mixed-effects model|||||-1.20|-2.00|< 0.001
71130153|NCT01620528|141764603|SUPERIORITY||Difference in LS Means|-6.29|STANDARD_ERROR_OF_MEAN|1.57|<|0.001|TWO_SIDED|95.0|-9.37|-3.21|||ANCOVA|||||-3.21|-9.37|< 0.001
71130154|NCT01620528|141764603|SUPERIORITY||Difference in LS Means|-9.76|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-12.91|-6.61|||ANCOVA|||||-6.61|-12.91|< 0.001
71130155|NCT01620528|141764604|SUPERIORITY||Difference in LS Means|-9.28|STANDARD_ERROR_OF_MEAN|1.72|<|0.001|TWO_SIDED|95.0|-12.66|-5.91|||ANCOVA|||||-5.91|-12.66|< 0.001
71130156|NCT01620528|141764604|SUPERIORITY||Difference in LS Means|-18.75|STANDARD_ERROR_OF_MEAN|1.77|<|0.001|TWO_SIDED|95.0|-22.22|-15.27|||ANCOVA|||||-15.27|-22.22|< 0.001
71130157|NCT01620528|141764605|SUPERIORITY||Difference in LS Means|-12.57|STANDARD_ERROR_OF_MEAN|1.99|<|0.001|TWO_SIDED|95.0|-16.48|-8.66|||ANCOVA|||||-8.66|-16.48|< 0.001
71130158|NCT01620528|141764605|SUPERIORITY||Difference in LS Means|-25.1|STANDARD_ERROR_OF_MEAN|2.04|<|0.001|TWO_SIDED|95.0|-29.12|-21.09|||ANCOVA|||||-21.09|-29.12|< 0.001
71130159|NCT01620528|141764606|SUPERIORITY||LS Mean of Difference|-0.78|STANDARD_ERROR_OF_MEAN|1.94||0.685|TWO_SIDED|95.0|-4.59|3.02|||ANCOVA|||||3.02|-4.59|0.685
71130160|NCT01620528|141764606|SUPERIORITY||Difference in LS Means|-5.04|STANDARD_ERROR_OF_MEAN|2.03||0.013|TWO_SIDED|95.0|-9.04|-1.05|||ANCOVA|||||-1.05|-9.04|0.013
71130161|NCT01620528|141764607|SUPERIORITY||Difference in LS Means|-4.74|STANDARD_ERROR_OF_MEAN|2.39||0.047|TWO_SIDED|95.0|-9.43|-0.05|||ANCOVA|||||-0.05|-9.43|0.047
71130162|NCT01620528|141764607|SUPERIORITY||Difference in LS Means|-13.86|STANDARD_ERROR_OF_MEAN|2.56|<|0.001|TWO_SIDED|95.0|-18.89|-8.84|||ANCOVA|||||-8.84|-18.89|< 0.001
71130163|NCT01620528|141764608|SUPERIORITY||Difference in LS Means|-4.71|STANDARD_ERROR_OF_MEAN|2.91||0.107|TWO_SIDED|95.0|-10.43|1.02|||ANCOVA|||||1.02|-10.43|0.107
71130164|NCT01620528|141764608|SUPERIORITY||Difference in LS Means|-17.51|STANDARD_ERROR_OF_MEAN|3.06|<|0.001|TWO_SIDED|95.0|-23.52|-11.5|||ANCOVA|||||-11.50|-23.52|< 0.001
71130165|NCT01620528|141764609|SUPERIORITY||Difference in LS Means|0.12|STANDARD_ERROR_OF_MEAN|0.37||0.741|TWO_SIDED|95.0|-0.61|0.85|||ANCOVA|||||0.85|-0.61|0.741
71130166|NCT01620528|141764609|SUPERIORITY||Difference in LS Means|-1.16|STANDARD_ERROR_OF_MEAN|0.38||0.002|TWO_SIDED|95.0|-1.9|-0.42|||ANCOVA|||||-0.42|-1.90|0.002
70946947|NCT04358068|141394078|SUPERIORITY|Participant specific durations were compared between randomized arms using a two-sided Wilcoxon test with a two-sided 5% type I error rate||||||0.79||||||Wilcoxon Test was not stratified by high/low risk because of the small number enrolled|Wilcoxon (Mann-Whitney)|||||||0.79
70946948|NCT04358068|141394079|SUPERIORITY|Participant specific AUCs were compared between randomized arms using a two-sided Wilcoxon test with a two-sided 5% type I error rate||||||0.53||||||Wilcoxon Test was not stratified by high/low risk because of the small number enrolled|Wilcoxon (Mann-Whitney)|||||||0.53
70946949|NCT04358068|141394080|SUPERIORITY|Participant specific durations were compared between randomized arms using a two-sided Wilcoxon test with a two-sided 5% type I error rate||||||0.83||||||Wilcoxon Test was not stratified by high/low risk because of the small number enrolled|Wilcoxon (Mann-Whitney)|||||||0.83
70946950|NCT00239681|141394084|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.56|||<|0.0001||95.0|0.46|0.69|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)|||0.69|0.46|<0.0001
70859264|NCT02882074|141204939|SUPERIORITY||Ratio of geometric means|1.19||||0.257|TWO_SIDED|97.5|0.84|1.68||The significance criterion is p-value \< 0.025 (i.e. 0.05/2), corrected for multiple comparisons.|Mixed Models Analysis||Endocan values were all log-transformed to meet the linearity requirement. Thus the treatment effect was presented as the ratio of geometric means.|||1.68|0.84|0.257
70946951|NCT00239681|141394085|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||<|0.021||95.0|0.67|0.97|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)|||0.97|0.67|<0.021
71130167|NCT01620528|141764610|SUPERIORITY||Difference in LS Means|-0.47|STANDARD_ERROR_OF_MEAN|0.35||0.172|TWO_SIDED|95.0|-1.16|0.21|||ANCOVA|||||0.21|-1.16|0.172
71130168|NCT01620528|141764610|SUPERIORITY||Difference in LS Means|-1.27|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-1.97|-0.57|||ANCOVA|||||-0.57|-1.97|< 0.001
71130169|NCT01620528|141764611|SUPERIORITY||LS Mean of Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.43||0.016|TWO_SIDED|95.0|-1.9|-0.19|||ANCOVA|||||-0.19|-1.90|0.016
71130170|NCT01620528|141764611|SUPERIORITY||Difference in LS Means|-1.78|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED|95.0|-2.65|-0.91|||ANCOVA|||||-0.91|-2.65|< 0.001
71130171|NCT01620528|141764612|SUPERIORITY||Difference in LS Means|-0.77|STANDARD_ERROR_OF_MEAN|0.44||0.08|TWO_SIDED|95.0|-1.63|0.09|||ANCOVA|||||0.09|-1.63|0.080
70946952|NCT00239681|141394086|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84|||<|0.172||95.0|0.65|1.08|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)|||1.08|0.65|<0.172
70946953|NCT00239681|141394087|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.27|||<|0.015||95.0|1.05|1.53|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)|||1.53|1.05|<0.015
70946954|NCT00239681|141394088|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.018||95.0|0.35|0.91|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)|||0.91|0.35|0.018
70946955|NCT00239681|141394089|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.548||95.0|0.88|1.28|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)|||1.28|0.88|0.548
71130172|NCT01620528|141764612|SUPERIORITY||Difference in LS Means|-1.37|STANDARD_ERROR_OF_MEAN|0.45||0.003|TWO_SIDED|95.0|-2.25|-0.48|||ANCOVA|||||-0.48|-2.25|0.003
71130173|NCT01620528|141764613|SUPERIORITY||Difference in LS Means|-0.65|STANDARD_ERROR_OF_MEAN|0.4||0.106|TWO_SIDED|95.0|-1.44|0.14|||ANCOVA|||||0.14|-1.44|0.106
71130174|NCT01620528|141764613|SUPERIORITY||Difference in LS Means|-1.85|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-2.67|-1.02|||ANCOVA|||||-1.02|-2.67|< 0.001
71130175|NCT01620528|141764614|SUPERIORITY||Difference in LS Means|-0.75|STANDARD_ERROR_OF_MEAN|0.62||0.232|TWO_SIDED|95.0|-1.97|0.48|||ANCOVA|||||0.48|-1.97|0.232
71130176|NCT01620528|141764614|SUPERIORITY||Difference in LS Means|-2.21|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|-3.48|-0.93|||ANCOVA|||||-0.93|-3.48|< 0.001
71130177|NCT01620528|141764615|SUPERIORITY||Difference in LS Means|-0.92|STANDARD_ERROR_OF_MEAN|0.37||0.013|TWO_SIDED|95.0|-1.65|-0.2|||ANCOVA|||||-0.20|-1.65|0.013
71130178|NCT01620528|141764615|SUPERIORITY||Difference in LS Means|-1.62|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.35|-0.9|||ANCOVA|||||-0.90|-2.35|< 0.001
71130179|NCT01620528|141764616|SUPERIORITY||Difference in LS Means|-1.33|STANDARD_ERROR_OF_MEAN|0.47||0.005|TWO_SIDED|95.0|-2.24|-0.41|||ANCOVA|||||-0.41|-2.24|0.005
71130180|NCT01620528|141764616|SUPERIORITY||Difference in LS Means|-1.64|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|-2.56|-0.71|||ANCOVA|||||-0.71|-2.56|< 0.001
71130181|NCT01620528|141764617|SUPERIORITY||Difference in LS Means|-1.63|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|-2.53|-0.72|||ANCOVA|||||-0.72|-2.53|< 0.001
71130182|NCT01620528|141764617|SUPERIORITY||Difference in LS Means|-2.1|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|-3.02|-1.19|||ANCOVA|||||-1.19|-3.02|< 0.001
71130183|NCT01620528|141764618|SUPERIORITY||Difference in LS Means|-1.21|STANDARD_ERROR_OF_MEAN|0.42||0.004|TWO_SIDED|95.0|-2.05|-0.38|||ANCOVA|||||-0.38|-2.05|0.004
71130184|NCT01620528|141764618|SUPERIORITY||Difference in LS Means|-2.23|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-3.06|-1.4|||ANCOVA|||||-1.40|-3.06|< 0.001
71130185|NCT01620528|141764619|SUPERIORITY||Difference in LS Means|-0.97|STANDARD_ERROR_OF_MEAN|0.39||0.013|TWO_SIDED|95.0|-1.74|-0.2|||ANCOVA|||||-0.20|-1.74|0.013
71130186|NCT01620528|141764619|SUPERIORITY||Difference in LS Means|-1.81|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-2.58|-1.04|||ANCOVA|||||-1.04|-2.58|< 0.001
71130187|NCT01620528|141764620|SUPERIORITY||Difference in LS Means|-1.28|STANDARD_ERROR_OF_MEAN|0.48||0.007|TWO_SIDED|95.0|-2.22|-0.34|||ANCOVA|||||-0.34|-2.22|0.007
71130188|NCT01620528|141764620|SUPERIORITY||Difference in LS Means|-2.49|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|-3.44|-1.54|||ANCOVA|||||-1.54|-3.44|< 0.001
71130189|NCT01620528|141764621|SUPERIORITY||Difference in LS Means|-0.86|STANDARD_ERROR_OF_MEAN|0.87||0.326|TWO_SIDED|95.0|-2.57|0.85|||ANCOVA|||||0.85|-2.57|0.326
71130190|NCT01620528|141764621|SUPERIORITY||Difference in LS Means|-1.93|STANDARD_ERROR_OF_MEAN|0.89||0.031|TWO_SIDED|95.0|-3.67|-0.18|||ANCOVA|||||-0.18|-3.67|0.031
71130191|NCT01620528|141764622|SUPERIORITY||Difference in LS Means|-1.41|STANDARD_ERROR_OF_MEAN|0.88||0.107|TWO_SIDED|95.0|-3.13|0.31|||ANCOVA|||||0.31|-3.13|0.107
71130192|NCT01620528|141764622|SUPERIORITY||Difference in LS Means|-3.52|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.28|-1.75|||ANCOVA|||||-1.75|-5.28|< 0.001
71130193|NCT01620528|141764623|SUPERIORITY||Difference in LS Means|-1.01|STANDARD_ERROR_OF_MEAN|0.82||0.219|TWO_SIDED|95.0|-2.63|0.6|||ANCOVA|||||0.60|-2.63|0.219
70859265|NCT02882074|141204940|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.003|TWO_SIDED|95.0|0.23|1.01|||Regression, Linear|||||1.01|0.23|0.003
71130194|NCT01620528|141764623|SUPERIORITY||Difference in LS Means|-2.93|STANDARD_ERROR_OF_MEAN|0.84|<|0.001|TWO_SIDED|95.0|-4.59|-1.28|||ANCOVA|||||-1.28|-4.59|< 0.001
71130195|NCT01620528|141764624|SUPERIORITY||Difference in LS Means|-1.6|STANDARD_ERROR_OF_MEAN|0.72||0.026|TWO_SIDED|95.0|-3.01|-0.19|||ANCOVA|||||-0.19|-3.01|0.026
71130196|NCT01620528|141764624|SUPERIORITY||Difference in LS Means|-3.89|STANDARD_ERROR_OF_MEAN|0.74|<|0.001|TWO_SIDED|95.0|-5.34|-2.43|||ANCOVA|||||-2.43|-5.34|< 0.001
71130197|NCT01620528|141764625|SUPERIORITY||Difference in LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.76||0.502|TWO_SIDED|95.0|-2.0|0.98|||ANCOVA|||||0.98|-2.00|0.502
71130198|NCT01620528|141764625|SUPERIORITY||Difference in LS Means|-3.13|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|-4.7|-1.56|||ANCOVA|||||-1.56|-4.70|< 0.001
71130199|NCT01620528|141764626|SUPERIORITY||Difference in LS Means|-1.36|STANDARD_ERROR_OF_MEAN|0.85||0.108|TWO_SIDED|95.0|-3.02|0.3|||ANCOVA|||||0.30|-3.02|0.108
71130200|NCT01620528|141764626|SUPERIORITY||Difference in LS Means|-4.47|STANDARD_ERROR_OF_MEAN|0.88|<|0.001|TWO_SIDED|95.0|-6.19|-2.74|||ANCOVA|||||-2.74|-6.19|< 0.001
70859266|NCT03780400|141204946|OTHER|test for within group change from baseline to 4 month follow-up||||||0.5145|||||||t-test, 2 sided|||||||0.5145
70859267|NCT03780400|141204947|OTHER|test for within group change from baseline to 4 month follow-up||||||0.3683|||||||t-test, 2 sided|||||||0.3683
70859268|NCT03780400|141204948|OTHER|test for within group change from baseline to 4 month follow-up||||||0.9858|||||||t-test, 2 sided|||||||0.9858
70859269|NCT03780400|141204949|OTHER|test for within group change from baseline to 4 month follow-up|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70859270|NCT03780400|141204950|OTHER|test for within group change from baseline to 4 month follow-up|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71130201|NCT01620528|141764627|SUPERIORITY||Difference in LS Means|-1.19|STANDARD_ERROR_OF_MEAN|0.36||0.001|TWO_SIDED|95.0|-1.9|-0.48|||ANCOVA|||||-0.48|-1.90|0.001
71130202|NCT01620528|141764627|SUPERIORITY||Difference in LS Means|-1.05|STANDARD_ERROR_OF_MEAN|0.36||0.004|TWO_SIDED|95.0|-1.76|-0.34|||ANCOVA|||||-0.34|-1.76|0.004
71130203|NCT01620528|141764628|SUPERIORITY||Difference in LS Means|-0.76|STANDARD_ERROR_OF_MEAN|0.38||0.045|TWO_SIDED|95.0|-1.49|-0.02|||mixed-effects model|||||-0.02|-1.49|0.045
71130204|NCT01620528|141764628|SUPERIORITY||Difference in LS Means|-1.06|STANDARD_ERROR_OF_MEAN|0.38||0.006|TWO_SIDED|95.0|-1.81|-0.31|||ANCOVA|||||-0.31|-1.81|0.006
71130205|NCT01620528|141764629|SUPERIORITY||Difference in LS Means|-0.54|STANDARD_ERROR_OF_MEAN|0.33||0.103|TWO_SIDED|95.0|-1.19|0.11|||ANCOVA|||||0.11|-1.19|0.103
71130206|NCT01620528|141764629|SUPERIORITY||Difference in LS Means|-0.98|STANDARD_ERROR_OF_MEAN|0.34||0.003|TWO_SIDED|95.0|-1.64|-0.32|||ANCOVA|||||-0.32|-1.64|0.003
71130207|NCT01620528|141764630|SUPERIORITY||Difference in LS Means|-0.31|STANDARD_ERROR_OF_MEAN|0.36||0.39|TWO_SIDED|95.0|-1.01|0.4|||ANCOVA|||||0.40|-1.01|0.390
71130208|NCT01620528|141764630|SUPERIORITY||Difference in LS Means|-1.05|STANDARD_ERROR_OF_MEAN|0.36||0.003|TWO_SIDED|95.0|-1.75|-0.35|||ANCOVA|||||-0.35|-1.75|0.003
71130209|NCT01620528|141764631|SUPERIORITY||Difference in LS Means|-0.2|STANDARD_ERROR_OF_MEAN|0.27||0.46|TWO_SIDED|95.0|-0.72|0.32|||ANCOVA|||||0.32|-0.72|0.460
71130210|NCT01620528|141764631|SUPERIORITY||Difference in LS Means|-1.04|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.57|-0.52|||ANCOVA|||||-0.52|-1.57|< 0.001
71130211|NCT01620528|141764632|SUPERIORITY||LS Mean of Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.35||0.095|TWO_SIDED|95.0|-1.28|0.1|||ANCOVA|||||0.10|-1.28|0.095
71130212|NCT01620528|141764632|SUPERIORITY||Difference in LS Means|-1.3|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-2.01|-0.59|||ANCOVA|||||-0.59|-2.01|< 0.001
71130213|NCT01620528|141764633|SUPERIORITY||Difference in LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.97||0.462|TWO_SIDED|95.0|-2.61|1.19|||ANCOVA|||||1.19|-2.61|0.462
71130214|NCT01620528|141764633|SUPERIORITY||Difference in LS Means|-3.23|STANDARD_ERROR_OF_MEAN|0.98||0.001|TWO_SIDED|95.0|-5.16|-1.3|||ANCOVA|||||-1.30|-5.16|0.001
71130215|NCT01620528|141764634|SUPERIORITY||Difference in LS Means|-2.02|STANDARD_ERROR_OF_MEAN|0.97||0.039|TWO_SIDED|95.0|-3.93|-0.11|||ANCOVA|||||-0.11|-3.93|0.039
71130216|NCT01620528|141764634|SUPERIORITY||Difference in LS Means|-4.86|STANDARD_ERROR_OF_MEAN|1.0|<|0.001|TWO_SIDED|95.0|-6.82|-2.9|||ANCOVA|||||-2.90|-6.82|< 0.001
71130217|NCT01620528|141764635|SUPERIORITY||Difference in LS Means|-2.2|STANDARD_ERROR_OF_MEAN|1.03||0.032|TWO_SIDED|95.0|-4.21|-0.18|||ANCOVA|||||-0.18|-4.21|0.032
71130218|NCT01620528|141764635|SUPERIORITY||Difference in LS Means|-4.91|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-6.95|-2.86|||ANCOVA|||||-2.86|-6.95|< 0.001
71130219|NCT01620528|141764636|SUPERIORITY||Difference in LS Means|-2.42|STANDARD_ERROR_OF_MEAN|0.94||0.01|TWO_SIDED|95.0|-4.26|-0.58|||ANCOVA|||||-0.58|-4.26|0.010
71130220|NCT01620528|141764636|SUPERIORITY||Difference in LS Means|-5.25|STANDARD_ERROR_OF_MEAN|0.96|<|0.001|TWO_SIDED|95.0|-7.14|-3.36|||ANCOVA|||||-3.36|-7.14|< 0.001
71130221|NCT01620528|141764637|SUPERIORITY||Difference in LS Means|-1.17|STANDARD_ERROR_OF_MEAN|0.94||0.215|TWO_SIDED|95.0|-3.02|0.68|||ANCOVA|||||0.68|-3.02|0.215
71130222|NCT01620528|141764637|SUPERIORITY||Difference in LS Means|-5.13|STANDARD_ERROR_OF_MEAN|0.98|<|0.001|TWO_SIDED|95.0|-7.06|-3.2|||ANCOVA|||||-3.20|-7.06|< 0.001
71130223|NCT01620528|141764638|SUPERIORITY||Difference in LS Means|-2.25|STANDARD_ERROR_OF_MEAN|1.16||0.053|TWO_SIDED|95.0|-4.53|0.03|||ANCOVA|||||0.03|-4.53|0.053
71130224|NCT01620528|141764638|SUPERIORITY||Difference in LS Means|-6.79|STANDARD_ERROR_OF_MEAN|1.21|<|0.001|TWO_SIDED|95.0|-9.17|-4.41|||ANCOVA|||||-4.41|-9.17|< 0.001
71130225|NCT01620528|141764639|SUPERIORITY||Difference in LS Means|-2.12|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|95.0|-3.24|-1.01|||ANCOVA|||||-1.01|-3.24|< 0.001
71130226|NCT01620528|141764639|SUPERIORITY||Difference in LS Means|-2.6|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|95.0|-3.71|-1.49|||ANCOVA|||||-1.49|-3.71|< 0.001
71130227|NCT01620528|141764640|SUPERIORITY||Difference in LS Means|-2.09|STANDARD_ERROR_OF_MEAN|0.67||0.002|TWO_SIDED|95.0|-3.4|-0.78|||ANCOVA|||||-0.78|-3.40|0.002
71130228|NCT01620528|141764640|SUPERIORITY||Difference in LS Means|-2.65|STANDARD_ERROR_OF_MEAN|0.68|<|0.001|TWO_SIDED|95.0|-3.98|-1.32|||ANCOVA|||||-1.32|-3.98|< 0.001
71130229|NCT01620528|141764641|SUPERIORITY||Difference in LS Means|-2.17|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|-3.39|-0.95|||ANCOVA|||||-0.95|-3.39|< 0.001
70946956|NCT03599622|141394099|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|4.3||||0.5812|TWO_SIDED|95.0|-11.0|19.5||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||19.5|-11.0|0.5812
70859271|NCT05867342|141204985|OTHER|||||||0.77||||||A p-value of \< 0.05 would be considered statistically significant.|t-test, 2 sided|||||||0.77
70859272|NCT05867342|141204986|OTHER|||||||0.002||||||A p-value of \< 0.05 would be considered statistically significant.|t-test, 2 sided|||||||0.002
70946957|NCT03599622|141394099|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|1.2||||0.5812|TWO_SIDED|95.0|0.6|2.5||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||2.5|0.6|0.5812
70859273|NCT05867342|141204987|OTHER|||||||0.126||||||A p-value of \< 0.05 would be considered statistically significant.|t-test, 2 sided|||||||0.126
70859274|NCT05867342|141204989|OTHER|||||||0.213||||||A p-value of \< 0.05 would be considered statistically significant.|t-test, 2 sided|||||||0.213
70859275|NCT05867342|141204990|OTHER|||||||0.418||||||A p-value of \< 0.05 would be considered statistically significant.|t-test, 2 sided|||||||0.418
70859276|NCT05867342|141204991|OTHER|||||||0.756||||||A p-value of \< 0.05 would be considered statistically significant.|t-test, 2 sided|||||||0.756
70859277|NCT03190369|141205007|SUPERIORITY||LS Mean difference|0.125|STANDARD_ERROR_OF_MEAN|0.137||0.361|TWO_SIDED|95.0|-0.144|0.395||Threshold for significance at 0.05 level.|ANCOVA|Least-square (LS) means, standard errors (SE) were analyzed from repeated measures ANCOVA.||Least-square (LS) means, standard errors (SE) were analyzed from repeated measures analysis of covariance (ANCOVA). The model included treatment groups (Hylan G-F 20 and placebo), site, visit and visit by treatment interaction, as well as the baseline WOMAC A1 score as a covariate).||0.395|-0.144|0.3610
70859278|NCT04543409|141205022|SUPERIORITY||Odds Ratio (OR)|117.49|||<|0.0001|TWO_SIDED|95.0|38.17|361.64|||Cochran-Mantel-Haenszel||The OR estimate and p-value was obtained from the CMH test controlling for region (North America and Rest of the world), baseline steroid use, and presence of strictures at baseline. Odds ratio values \>1 favor Benra 30 mg treatment group.|Analysis completed at Week 24.||361.64|38.17|<0.0001
70859279|NCT04543409|141205023|SUPERIORITY|For any patients with intercurrent events, the DSQ scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR). Analysis was repeated on 100 imputed datasets, and results were combined using Rubin's formula.|Difference in Least Squares Means|2.999||||0.177|TWO_SIDED|95.0|-1.36|7.35|||ANCOVA|Model: Change from baseline in DSQ = Treatment + baseline DSQ + Region + Baseline steroid use + Presence of strictures at baseline.||Analysis completed at Week 24.||7.35|-1.36|0.1770
70859280|NCT04543409|141205024|SUPERIORITY|For any patients with intercurrent events, the Peak Esophageal intraepithelial eosinophil (eos) counts after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-96.2|||<|0.0001|TWO_SIDED|95.0|-114.53|-77.85|||ANCOVA|Model: Percent change from baseline in Peak Esophageal intraepithelial eos counts = Treatment + baseline Peak Esophageal intraepithelial eos counts.||Analysis completed at Week 24.||-77.85|-114.53|<0.0001
70859281|NCT04543409|141205025|SUPERIORITY|For any patients with intercurrent events, the EoE-HSS total grade score after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.175|||<|0.0001|TWO_SIDED|95.0|-0.21|-0.14|||ANCOVA|Change from baseline in EoE-HSS TGS = Treatment + baseline EoE-HSS grade score + Region + Baseline steroid use + Presence of strictures at baseline||||-0.14|-0.21|<0.0001
70859282|NCT04543409|141205026|SUPERIORITY|For any patients with intercurrent events, the EoE-HSS total stage score after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.122|||<|0.0001|TWO_SIDED|95.0|-0.16|-0.09|||ANCOVA|Change from baseline in EoE-HSS TSS = Treatment + baseline EoE-HSS stage score + Region + Baseline steroid use + Presence of strictures at baseline||||-0.09|-0.16|<0.0001
70859283|NCT04543409|141205027|SUPERIORITY|For any patients with intercurrent events, the centrally-read EREFS total score after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.1||||0.7322|TWO_SIDED|95.0|-0.52|0.32|||ANCOVA|Model: Change from baseline in EREFS TS = Treatment + baseline EREFS TS + Region + Baseline steroid use + Presence of strictures at baseline||Analysis completed at Week 24.||0.32|-0.52|0.7322
70859284|NCT04543409|141205028|SUPERIORITY||Odds Ratio (OR)|15.86|||<|0.0001|TWO_SIDED|95.0|5.79|43.47|||Cochran-Mantel-Haenszel||Controlling for region (North America and Rest of the world), baseline steroid use, and presence of strictures at baseline. OR values \>1 would favor Benra 30 mg treatment group.|||43.47|5.79|<0.0001
70859285|NCT04543409|141205032|SUPERIORITY|For any patients with intercurrent events, the EoE-3D scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.04||||0.8656|TWO_SIDED|95.0|-0.5|0.42|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||Dysphagia-related pain.||0.42|-0.50|0.8656
70859286|NCT04543409|141205032|SUPERIORITY|For any patients with intercurrent events, the EoE-3D scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.181||||0.3926|TWO_SIDED|95.0|-0.6|0.23|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||Dysphagia-related discomfort.||0.23|-0.60|0.3926
70946958|NCT03599622|141394099|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|-6.3||||0.372|TWO_SIDED|95.0|-20.2|7.6||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||7.6|-20.2|0.3720
70859287|NCT04543409|141205032|SUPERIORITY|For any patients with intercurrent events, the EoE-3D scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.344||||0.0867|TWO_SIDED|95.0|-0.74|0.05|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Overall episode severity.||0.05|-0.74|0.0867
70859288|NCT04543409|141205034|SUPERIORITY|For any patients with intercurrent events, the EoE-3D scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.267||||0.2248|TWO_SIDED|95.0|-0.16|0.7|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||Abdominal pain severity||0.70|-0.16|0.2248
71130230|NCT01620528|141764641|SUPERIORITY||Difference in LS Means|-3.0|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|-4.23|-1.76|||ANCOVA|||||-1.76|-4.23|< 0.001
70859289|NCT04543409|141205034|SUPERIORITY|For any patients with intercurrent events, the EoE-3D scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.296||||0.1575|TWO_SIDED|95.0|-0.11|0.71|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Nausea severity.||0.71|-0.11|0.1575
70859290|NCT04543409|141205037|SUPERIORITY|For any patients with intercurrent events, the EoE-QoL-A scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.202||||0.8239|TWO_SIDED|95.0|-1.57|1.98|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||Eating/Diet Impact||1.98|-1.57|0.8239
70859291|NCT04543409|141205037|SUPERIORITY|For any patients with intercurrent events, the EoE-QoL-A scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.147||||0.7623|TWO_SIDED|95.0|-0.8|1.1|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Social Impact||1.10|-0.80|0.7623
70859292|NCT04543409|141205037|SUPERIORITY|For any patients with intercurrent events, the EoE-QoL-A scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference of Least Squares Means|0.01||||0.9898|TWO_SIDED|95.0|-1.47|1.49|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Emotional Impact||1.49|-1.47|0.9898
70859293|NCT04543409|141205037|SUPERIORITY|For any patients with intercurrent events, the EoE-QoL-A scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.386||||0.4603|TWO_SIDED|95.0|-0.64|1.41|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Disease Anxiety||1.41|-0.64|0.4603
70946959|NCT03599622|141394099|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|0.7||||0.372|TWO_SIDED|95.0|0.3|1.5||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||1.5|0.3|0.3720
70946960|NCT03599622|141394100|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|15.0||||0.0198|TWO_SIDED|95.0|3.7|26.3||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||26.3|3.7|0.0198
70946961|NCT03599622|141394100|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|3.4||||0.0198|TWO_SIDED|95.0|1.2|9.8||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||9.8|1.2|0.0198
71130231|NCT01620528|141764642|SUPERIORITY||Difference in LS Means|-1.54|STANDARD_ERROR_OF_MEAN|0.64||0.017|TWO_SIDED|95.0|-2.8|-0.27|||ANCOVA|||||-0.27|-2.80|0.017
71130232|NCT01620528|141764642|SUPERIORITY||Difference in LS Means|-3.24|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-4.5|-1.98|||ANCOVA|||||-1.98|-4.50|< 0.001
71130233|NCT01620528|141764643|SUPERIORITY||Difference in LS Means|-1.14|STANDARD_ERROR_OF_MEAN|0.55||0.038|TWO_SIDED|95.0|-2.22|-0.07|||ANCOVA|||||-0.07|-2.22|0.038
71130234|NCT01620528|141764643|SUPERIORITY||Difference in LS Means|-2.83|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|-3.91|-1.74|||ANCOVA|||||-1.74|-3.91|< 0.001
71130235|NCT01620528|141764644|SUPERIORITY||Difference in LS Means|-1.83|STANDARD_ERROR_OF_MEAN|0.66||0.006|TWO_SIDED|95.0|-3.13|-0.54|||ANCOVA|||||-0.54|-3.13|0.006
71130236|NCT01620528|141764644|SUPERIORITY||Difference in LS Means|-3.75|STANDARD_ERROR_OF_MEAN|0.67|<|0.001|TWO_SIDED|95.0|-5.06|-2.44|||ANCOVA|||||-2.44|-5.06|< 0.001
71130237|NCT01457846|141764648|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.57||||0.9581|TWO_SIDED|80.0|1.12|2.21||1-sided|Regression, Cox|||||2.21|1.12|0.9581
71130238|NCT01457846|141764649|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||0.8156|TWO_SIDED|80.0|0.89|1.95||1-sided|Regression, Cox|||||1.95|0.89|0.8156
71130239|NCT01457846|141764650|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.09||||0.997|TWO_SIDED|80.0|0.02|0.35||1-sided|Regression, Logistic|||||0.35|0.02|0.9970
71130240|NCT01743040|141764653|NON_INFERIORITY|15% equivalency margin against performance of SPECT nuclear stress test OPC. Both sensitivity and specificity were measured and the equivalency margin was set the same for both parameters.The goal was to test the Sensitivity and specificity of CADence as compared to SPECT nuclear stress test OPC. Both were measured and reported in this study. The Sensitivity of CADence was 78% (95% CI 76.1-90.8%) while the specificity was 36% (95% CI 32-39%).||||||0.012|||||||Exact binomial test|||The goal was to test the Sensitivity and specificity of CADence as compared to SPECT nuclear stress test OPC. Both were measured and reported in this study. The Sensitivity of CADence was 78% (95% CI 76.1-90.8%) while the specificity was 36% (95% CI 32-39%).||||0.012
71130241|NCT03824587|141764655|SUPERIORITY||Mean Difference (Net)|-0.65|STANDARD_ERROR_OF_MEAN|0.182||0.0004|TWO_SIDED|99.0|-1.13|-0.18|||Mixed Models Analysis|||||-0.18|-1.13|0.0004
71130242|NCT03824587|141764656|SUPERIORITY||Odds Ratio (OR)|2.1||||0.0097|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0097
71130243|NCT03824587|141764657|SUPERIORITY|||||||0.0027|||||||ANOVA|||||||0.0027
71130244|NCT03824587|141764658|SUPERIORITY|||||||0.0011|||||||ANOVA|||||||0.0011
71130245|NCT00986362|141764659|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.613||||0.679|TWO_SIDED|95.0|0.07|4.509|||Fisher Exact|||||4.509|0.070|0.679
71130246|NCT01007838|141764677|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||Statistical significance was accepted if p \< 0.05.|ANCOVA|||Omnibus ANCOVA. An interaction would suggests patients responded to exercise differently than controls||||0.30
71130247|NCT01007838|141764677|SUPERIORITY_OR_OTHER|||||||0.0017||95.0||||Statistical significance was accepted if p \< 0.05.|ANOVA|||Follow up ANOVA in chronic kideny disease patients only. An interaction would suggest patients allocated to the resistance exercise group increased muscle size more than those allocated to the sham exercise group.||||0.0017
70946962|NCT03599622|141394100|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|8.2||||0.1584|TWO_SIDED|95.0|-2.6|19.0||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||19.0|-2.6|0.1584
71130248|NCT01007838|141764677|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||Statistical sigficance was accepted if p \< 0.05.|ANOVA|||Follow up ANOVA in healthy controls only. An interaction would suggest healthy controls allocated to the resistance exercise group increased muscle size more than those allocated to the sham exercise group.||||0.024
71130249|NCT04167137|141764679|OTHER|||||||||||||||||Because only 1 participant experienced a DLT (Grade 3 cytokine release syndrome in Arm 1 Cohort 6), no MTD could be reached.|Because only 1 participant experienced a DLT (Grade 3 cytokine release syndrome in Arm 1 Cohort 6), no MTD could be reached.|||
71130250|NCT00997594|141764686|NON_INFERIORITY_OR_EQUIVALENCE|Just a comparison of the percentage of hypertension between the 2 patient groups.|||||<|0.05||95.0|||||Chi-squared, Corrected|||||||<0.05
71130251|NCT02467582|141764687|SUPERIORITY|||||||0.11|||||||Log Rank|||||||0.11
71130252|NCT02467582|141764687|SUPERIORITY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|90.0|0.27|1.22|||||Unstratified|||1.22|0.27|
71130253|NCT02467582|141764687|SUPERIORITY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|90.0|0.22|1.46|||||Stratified|||1.46|0.22|
71130254|NCT02467582|141764688|SUPERIORITY|||||||0.089|||||||Log Rank|||||||0.089
71130255|NCT02467582|141764688|SUPERIORITY||Hazard Ratio (HR)|0.49|||||TWO_SIDED|90.0|0.21|1.19|||||Unstratified|||1.19|0.21|
71130256|NCT02467582|141764688|SUPERIORITY||Hazard Ratio (HR)|0.56|||||TWO_SIDED|90.0|0.2|1.55|||||Stratified|||1.55|0.20|
71130257|NCT02467582|141764689|SUPERIORITY|||||||0.3|||||||Log Rank|||||||0.3
71130258|NCT02467582|141764689|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|90.0|0.23|2.13|||||Unstratified|||2.13|0.23|
71130259|NCT02467582|141764689|SUPERIORITY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|90.0|0.15|2.43|||||Stratified|||2.43|0.15|
70859294|NCT04543409|141205037|SUPERIORITY|For any patients with intercurrent events, the EoE-QoL-A scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.162||||0.6613|TWO_SIDED|95.0|-0.89|0.56|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Swallowing Anxiety||0.56|-0.89|0.6613
70859295|NCT04543409|141205037|SUPERIORITY|For any patients with intercurrent events, the EoE-QoL-A scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|1.017||||0.6965|TWO_SIDED|95.0|-4.09|6.13|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Total Score||6.13|-4.09|0.6965
70859296|NCT04543409|141205039|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.3||||0.6852|TWO_SIDED|95.0|-1.93|1.27|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||Physical functioning (PF)||1.27|-1.93|0.6852
70859297|NCT04543409|141205039|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.9||||0.2685|TWO_SIDED|95.0|-2.57|0.72|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Role limitations due to physical health (RP)||0.72|-2.57|0.2685
70859298|NCT04543409|141205039|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.8||||0.538|TWO_SIDED|95.0|-3.27|1.71|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Bodily pain (BP)||1.71|-3.27|0.5380
70859299|NCT04543409|141205039|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.0||||0.9734|TWO_SIDED|95.0|-1.81|1.75|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||General health perceptions (GH)||1.75|-1.81|0.9734
70859300|NCT04543409|141205039|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.0||||0.9653|TWO_SIDED|95.0|-2.09|2.19|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Vitality (VT)||2.19|-2.09|0.9653
70859301|NCT04543409|141205039|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-1.5||||0.2326|TWO_SIDED|95.0|-4.04|0.98|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Social functioning (SF)||0.98|-4.04|0.2326
70859302|NCT04543409|141205039|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.7||||0.6274|TWO_SIDED|95.0|-3.44|2.08|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Role limitations due to emotional problems (RE)||2.08|-3.44|0.6274
70859303|NCT04543409|141205039|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.9||||0.4599|TWO_SIDED|95.0|-3.14|1.42|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Mental health (MH)||1.42|-3.14|0.4599
70859304|NCT04543409|141205039|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.4||||0.6456|TWO_SIDED|95.0|-2.07|1.28|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Psychometrically-based physical summary score (PCS)||1.28|-2.07|0.6456
70859305|NCT04543409|141205039|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.6||||0.6206|TWO_SIDED|95.0|-3.08|1.84|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||Mental health component summary scores (MCS)||1.84|-3.08|0.6206
70859306|NCT01923168|141205051|OTHER|Bayesian double criteria|Mean Difference (Final Values)|-1.3||||0.282|TWO_SIDED|80.0|-4.5|1.7|||Posterior mean diff. & credible interval|||||1.7|-4.5|0.282
70946963|NCT03599622|141394100|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|2.1||||0.1584|TWO_SIDED|95.0|0.7|6.1||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||6.1|0.7|0.1584
70859307|NCT01923168|141205052|OTHER|Bayesian double criteria|Mean Difference (Final Values)|1.1||||0.697|TWO_SIDED|80.0|-1.9|4.2|||Posterior mean difference|Posterior mean difference||||4.2|-1.9|0.697
70859308|NCT01923168|141205053|OTHER|Bayesian double criteria|Mean Difference (Final Values)|-1.4||||0.435|TWO_SIDED|80.0|-12.5|9.7|||Posterior mean diff. & credible interval|||||9.7|-12.5|0.435
71130260|NCT01370265|141764692|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||t-test, 2 sided|||Statistical analysis for hyperemic global MBF between Regadenoson and Adenosine groups (per intervention), alpha level of 0.05.||||0.14
70859309|NCT01923168|141205054|OTHER|Bayesian double criteria|Mean Difference (Final Values)|2.4||||0.611|TWO_SIDED|80.0|-8.4|13.2|||Posterior mean diff. & credible interval|||||13.2|-8.4|0.611
71130261|NCT01370265|141764694|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||t-test, 2 sided|||Statistical analysis for Cardiac Flow Rate (CFR) between Regadenoson and Adenosine groups (per intervention), alpha level of 0.05||||0.21
71130262|NCT01370265|141764695|SUPERIORITY_OR_OTHER|||||||0.57||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention), for Hyperemic MBF Anterior, alpha level of 0.05.||||0.57
70859310|NCT03101267|141205124|SUPERIORITY||Adjusted mean difference|0.09||||0.777|TWO_SIDED|95.0|-0.52|0.69|||Mixed model for repeated measures (MMRM)|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||3TNSS treatment comparison||0.69|-0.52|0.777
70859311|NCT03101267|141205124|SUPERIORITY||Adjusted mean difference|-0.01||||0.983||95.0|-0.61|0.59|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||3TNSS treatment comparison||0.59|-0.61|0.983
71130263|NCT01370265|141764695|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for Hyperemic MBF Septum, alpha level of 0.05.||||0.13
71130264|NCT01370265|141764695|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention)for Hyperemic MBF Inferior, alpha level of 0.05.||||0.44
71130265|NCT01370265|141764695|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for Hyperemic MBF Lateral, alpha level of 0.05.||||0.74
71130266|NCT01370265|141764696|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention for CFR Anterior, alpha level of 0.05.||||0.78
71130267|NCT01370265|141764696|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for CFR Septum, alpha level of 0.05||||0.42
71130268|NCT01370265|141764696|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention for CFR Inferior, alpha level of 0.05||||0.96
71130269|NCT01370265|141764696|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for CFR Lateral, alpha level of 0.05.||||0.13
71130270|NCT01370265|141764697|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for resting heart rate, alpha level of 0.05.||||0.28
71130271|NCT01370265|141764697|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for hyperemic heart rate, alpha level of 0.05.||||0.51
71130272|NCT01370265|141764698|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for systolic blood pressure, alpha level of 0.05.||||0.31
71130273|NCT01370265|141764698|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for diastolic blood pressure, alpha level of 0.05.||||0.08
71130274|NCT02611817|141764699|SUPERIORITY||Clopper-Pearson method|13.7||||0.008|TWO_SIDED|95.0|3.8|23.7|||Cochran-Mantel-Haenszel|||P-value was calculated by Cochran-Mantel-Haenszel (CMH) test stratified by electronic data capture (EDC) stratum according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-alpha antagonist failure/exposed or concomitant immunomodulator use.||23.7|3.8|0.008
71130275|NCT02611817|141764700|SUPERIORITY||Clopper-Pearson method|7.3||||0.167|TWO_SIDED|95.0|-3.0|17.5|||Cochran-Mantel-Haenszel|||P-value was calculated by CMH test stratified by EDC stratum according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-alpha antagonist failure/exposed or concomitant immunomodulator use.||17.5|-3.0|0.167
71130276|NCT02611817|141764701|SUPERIORITY||Clopper-Pearson method|27.1||||0.002|TWO_SIDED|95.0|11.9|42.3|||Cochran-Mantel-Haenszel|||P-value was calculated by CMH test stratified by EDC stratum according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-alpha antagonist failure/exposed or concomitant immunomodulator use.||42.3|11.9|0.002
71130277|NCT02611817|141764702|SUPERIORITY||Clopper-Pearson method|4.3||||0.591|TWO_SIDED|95.0|-11.6|20.3|||Cochran-Mantel-Haenszel|||P-value was calculated by CMH test stratified by EDC stratum according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-alpha antagonist failure/exposed or concomitant immunomodulator use.||20.3|-11.6|0.591
71130278|NCT00265317|141764703|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.898||||0.3206|TWO_SIDED|80.0|0.575|1.404||Primary analysis was based on an unstratified 1-sided log rank test with alpha=0.1|Log Rank|||Sample size for randomized portion of study determined based on these assumptions: median PFS (erlotinib)=10 weeks, accrual time=12 months. With 6 months follow-up, study was powered to detect a difference in PFS of 5 weeks. 1-sided log rank test comparing the 2 treatment groups with 115 events of PD or death among a target sample size of 126 participants (63 per group) achieved 80% power at a 10% significance level to detect a 50% improvement in PFS from 10 to 15 weeks.||1.404|0.575|0.3206
71130279|NCT00265317|141764704|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.546||||0.6251|TWO_SIDED|95.0|0.267|8.954|||Cochran-Mantel-Haenszel|||95% confidence interval (CI) calculated based on f-distribution||8.954|0.267|0.6251
71130280|NCT00265317|141764705|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.921||||0.3732|TWO_SIDED|95.0|0.572|1.485||1-sided unstratified log-rank test|Log Rank|||||1.485|0.572|0.3732
71130281|NCT00265317|141764707|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.066||||0.6171|TWO_SIDED|95.0|0.705|1.612||p-value from 1-sided unstratified log-rank test|Log Rank|||||1.612|0.705|0.6171
71130282|NCT00265317|141764708|SUPERIORITY_OR_OTHER||Percentage|32.0|||||TWO_SIDED|95.0|19.7|44.3||||||Percentage of participants surviving at 1 year in the Sunitinib + Erlotinib Treatment Group, estimated using the Kaplan-Meier method||44.3|19.7|
71130283|NCT00265317|141764708|SUPERIORITY_OR_OTHER||Percentage|42.0|||||TWO_SIDED|95.0|30.1|54.2||||||Percentage of participants surviving at 1 year in the Erlotinib + Placebo Treatment Group, estimated using the Kaplan-Meier method||54.2|30.1|
71130284|NCT00265317|141764736|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.748||||0.2247|TWO_SIDED|95.0|0.351|1.591|||Log Rank|||Positive EGFR Expression||1.591|0.351|0.2247
71130285|NCT00265317|141764736|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.184||||0.6797|TWO_SIDED|95.0|0.581|2.414|||Log Rank|||Negative EGFR Expression||2.414|0.581|0.6797
71130286|NCT00265317|141764736|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.632||||0.1693|TWO_SIDED|95.0|0.245|1.627|||Log Rank|||Unmeasured EGFR Expression||1.627|0.245|0.1693
71130287|NCT00265317|141764738|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.864||||0.3223|TWO_SIDED|95.0|0.458|1.628|||Log Rank|||Positive EGFR Expression||1.628|0.458|0.3223
71130288|NCT00265317|141764738|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.946||||0.4608|TWO_SIDED|95.0|0.362|2.474|||Log Rank|||Negative EGFR Expression||2.474|0.362|0.4608
70859312|NCT03101267|141205125|SUPERIORITY||Adjusted mean difference|0.17||||0.71|TWO_SIDED|95.0|-0.75|1.1|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||4TNSS treatment comparison at day 127||1.10|-0.75|0.710
70859313|NCT03101267|141205125|SUPERIORITY||Adjusted mean difference|0.07||||0.872|TWO_SIDED|95.0|-0.84|0.99|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||4TNSS treatment comparison at day 127||0.99|-0.84|0.872
70859314|NCT03101267|141205125|SUPERIORITY||Adjusted mean difference|0.18||||0.701|TWO_SIDED|95.0|-0.73|1.08|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||4TNSS treatment comparison at day 155||1.08|-0.73|0.701
70859315|NCT03101267|141205125|SUPERIORITY||Adjusted mean difference|-0.04||||0.925||95.0|-0.95|0.86|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||4TNSS treatment comparison at day 155||0.86|-0.95|0.925
70859316|NCT03101267|141205125|SUPERIORITY||Adjusted mean difference|0.16||||0.69|TWO_SIDED|95.0|-0.64|0.97|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||4TNSS treatment comparison at day 183||0.97|-0.64|0.690
70859317|NCT03101267|141205125|SUPERIORITY||Adjusted mean difference|0.07||||0.868|TWO_SIDED|95.0|-0.73|0.87|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||4TNSS treatment comparison at day 183||0.87|-0.73|0.868
70859318|NCT03101267|141205126|SUPERIORITY||Adjusted mean difference|0.07||||0.502|TWO_SIDED|95.0|-0.14|0.29|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Sneezing score treatment comparison at day 127||0.29|-0.14|0.502
70859319|NCT03101267|141205126|SUPERIORITY||Adjusted mean difference|-0.02||||0.879|TWO_SIDED|95.0|-0.23|0.2|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Sneezing score treatment comparison at day 127||0.20|-0.23|0.879
70859320|NCT03101267|141205126|SUPERIORITY||Adjusted mean difference|0.06||||0.444|TWO_SIDED|95.0|-0.1|0.22|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Sneezing score treatment comparison at day 155||0.22|-0.10|0.444
70859321|NCT03101267|141205126|SUPERIORITY||Adjusted mean difference|0.0||||0.987|TWO_SIDED|95.0|-0.16|0.16|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Sneezing score treatment comparison at day 155||0.16|-0.16|0.987
71130289|NCT00265317|141764738|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.632||||0.1693|TWO_SIDED|95.0|0.245|1.627|||Log Rank|||Unmeasured EGFR Expression||1.627|0.245|0.1693
70859322|NCT03101267|141205126|SUPERIORITY||Adjusted mean difference|0.03||||0.645|TWO_SIDED|95.0|-0.12|0.18|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Sneezing score treatment comparison at day 183||0.18|-0.12|0.645
70859323|NCT03101267|141205126|SUPERIORITY||Adjusted mean difference|-0.07||||0.357|TWO_SIDED|95.0|-0.22|0.08|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Sneezing score treatment comparison at day 183||0.08|-0.22|0.357
70859324|NCT03101267|141205127|SUPERIORITY||Adjusted mean difference|0.12||||0.472|TWO_SIDED|95.0|-0.2|0.44|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal discharge score treatment comparison at day 127||0.44|-0.20|0.472
70859325|NCT03101267|141205127|SUPERIORITY||Adjusted mean difference|-0.11||||0.497|TWO_SIDED|95.0|-0.43|0.21|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal discharge score treatment comparison at day 127||0.21|-0.43|0.497
70859326|NCT03101267|141205127|SUPERIORITY||Adjusted mean difference|0.04||||0.821|TWO_SIDED|95.0|-0.28|0.36|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal discharge score treatment comparison at day 155||0.36|-0.28|0.821
70859327|NCT03101267|141205127|SUPERIORITY||Adjusted mean difference|-0.13||||0.414|TWO_SIDED|95.0|-0.45|0.19|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal discharge score treatment comparison at day 155||0.19|-0.45|0.414
70859328|NCT03101267|141205127|SUPERIORITY||Adjusted mean difference|0.12||||0.414|TWO_SIDED|95.0|-0.17|0.41|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal discharge score treatment comparison at day 183||0.41|-0.17|0.414
70859329|NCT03101267|141205127|SUPERIORITY||Adjusted mean difference|0.08||||0.566|TWO_SIDED|95.0|-0.2|0.37|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal discharge score treatment comparison at day 183||0.37|-0.20|0.566
70859330|NCT03101267|141205128|SUPERIORITY||Adjusted mean difference|-0.04||||0.822||95.0|-0.37|0.3|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal congestion score treatment comparison at day 127||0.30|-0.37|0.822
70859331|NCT03101267|141205128|SUPERIORITY||Adjusted mean difference|0.09||||0.587|TWO_SIDED|95.0|-0.24|0.42|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal congestion score treatment comparison at day 127||0.42|-0.24|0.587
70859332|NCT03101267|141205128|SUPERIORITY||Adjusted mean difference|0.0||||0.975|TWO_SIDED|95.0|-0.3|0.31|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal congestion score treatment comparison at day 155||0.31|-0.30|0.975
70859333|NCT03101267|141205128|SUPERIORITY||Adjusted mean difference|0.0||||0.98|TWO_SIDED|95.0|-0.31|0.31|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal congestion score treatment comparison at day 155||0.31|-0.31|0.980
71130290|NCT00265317|141764740|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.049||||0.5526|TWO_SIDED|95.0|0.542|2.031|||Log Rank|||No EGFR Gene Copy Number Increase||2.031|0.542|0.5526
70859334|NCT03101267|141205128|SUPERIORITY||Adjusted mean difference|-0.07||||0.621|TWO_SIDED|95.0|-0.35|0.21|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal congestion score treatment comparison at day 183||0.21|-0.35|0.621
70859335|NCT03101267|141205128|SUPERIORITY||Adjusted mean difference|-0.03||||0.831|TWO_SIDED|95.0|-0.31|0.25|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal congestion score treatment comparison at day 183||0.25|-0.31|0.831
70859336|NCT03101267|141205129|SUPERIORITY||Adjusted mean difference|0.03||||0.864|TWO_SIDED|95.0|-0.29|0.35|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy nose score treatment comparison at day 127||0.35|-0.29|0.864
70859337|NCT03101267|141205129|SUPERIORITY||Adjusted mean difference|0.11||||0.502|TWO_SIDED|95.0|-0.21|0.43|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy nose score treatment comparison at day 127||0.43|-0.21|0.502
70859338|NCT03101267|141205129|SUPERIORITY||Adjusted mean difference|0.07||||0.652|TWO_SIDED|95.0|-0.25|0.4|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy nose score treatment comparison at day 155||0.40|-0.25|0.652
70859339|NCT03101267|141205129|SUPERIORITY||Adjusted mean difference|0.08||||0.633|TWO_SIDED|95.0|-0.25|0.41|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy nose score treatment comparison at day 155||0.41|-0.25|0.633
70859340|NCT03101267|141205129|SUPERIORITY||Adjusted mean difference|0.07||||0.596|TWO_SIDED|95.0|-0.2|0.35|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy nose score treatment comparison at day 183||0.35|-0.20|0.596
70859341|NCT03101267|141205129|SUPERIORITY||Adjusted mean difference|0.07||||0.621|TWO_SIDED|95.0|-0.21|0.34|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy nose score treatment comparison at day 183||0.34|-0.21|0.621
70859342|NCT03101267|141205130|SUPERIORITY||Adjusted mean difference|0.21||||0.336|TWO_SIDED|95.0|-0.22|0.65|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||TNNSS treatment comparison at day 127||0.65|-0.22|0.336
70946964|NCT03599622|141394101|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|7.7||||0.3464|TWO_SIDED|95.0|-8.2|23.6||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||23.6|-8.2|0.3464
70859343|NCT03101267|141205130|SUPERIORITY||Adjusted mean difference|0.36||||0.102|TWO_SIDED|95.0|-0.07|0.8|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||TNNSS treatment comparison at day 127||0.80|-0.07|0.102
70859344|NCT03101267|141205130|SUPERIORITY||Adjusted mean difference|0.11||||0.625|TWO_SIDED|95.0|-0.34|0.56|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||TNNSS treatment comparison at day 155||0.56|-0.34|0.625
70859345|NCT03101267|141205130|SUPERIORITY||Adjusted mean difference|0.33||||0.145|TWO_SIDED|95.0|-0.12|0.78|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||TNNSS treatment comparison at day 155||0.78|-0.12|0.145
70859346|NCT03101267|141205130|SUPERIORITY||Adjusted mean difference|0.19||||0.364|TWO_SIDED|95.0|-0.22|0.59|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||TNNSS treatment comparison at day 183||0.59|-0.22|0.364
70859347|NCT03101267|141205130|SUPERIORITY||Adjusted mean difference|0.35||||0.082|TWO_SIDED|95.0|-0.05|0.76|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||TNNSS treatment comparison at day 183||0.76|-0.05|0.082
70859348|NCT03101267|141205131|SUPERIORITY||Adjusted mean difference|0.07||||0.623|TWO_SIDED|95.0|-0.21|0.35|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy eyes treatment comparison at day 127||0.35|-0.21|0.623
70859349|NCT03101267|141205131|SUPERIORITY||Adjusted mean difference|0.15||||0.288|TWO_SIDED|95.0|-0.13|0.43|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy eyes treatment comparison at day 127||0.43|-0.13|0.288
70859350|NCT03101267|141205131|SUPERIORITY||Adjusted mean difference|0.03||||0.83|TWO_SIDED|95.0|-0.24|0.3|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy eyes treatment comparison at day 155||0.30|-0.24|0.830
70859351|NCT03101267|141205131|SUPERIORITY||Adjusted mean difference|0.17||||0.208|TWO_SIDED|95.0|-0.1|0.44|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy eyes treatment comparison at day 155||0.44|-0.10|0.208
70859352|NCT03101267|141205131|SUPERIORITY||Adjusted mean difference|0.06||||0.616|TWO_SIDED|95.0|-0.19|0.31|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy eyes treatment comparison at day 183||0.31|-0.19|0.616
70859353|NCT03101267|141205131|SUPERIORITY||Adjusted mean difference|0.16||||0.207|TWO_SIDED|95.0|-0.09|0.41|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy eyes treatment comparison at day 183||0.41|-0.09|0.207
70859354|NCT03101267|141205132|SUPERIORITY||Adjusted mean difference|0.15||||0.157|TWO_SIDED|95.0|-0.06|0.35|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Watery eyes treatment comparison at day 127||0.35|-0.06|0.157
71130291|NCT00265317|141764740|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.715||||0.1529|TWO_SIDED|95.0|0.38|1.344|||Log Rank|||Unmeasured EGFR Gene Copy Number Increase||1.344|0.380|0.1529
71130292|NCT00265317|141764742|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.078||||0.5839|TWO_SIDED|95.0|0.557|2.085|||Log Rank|||No EGFR Gene Amplification||2.085|0.557|0.5839
70859355|NCT03101267|141205132|SUPERIORITY||Adjusted mean difference|0.21||||0.039|TWO_SIDED|95.0|0.01|0.41|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Watery eyes treatment comparison at day 127||0.41|0.01|0.039
70859356|NCT03101267|141205132|SUPERIORITY||Adjusted mean difference|0.08||||0.459|TWO_SIDED|95.0|-0.14|0.3|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Watery eyes treatment comparison at day 155||0.30|-0.14|0.459
70859357|NCT03101267|141205132|SUPERIORITY||Adjusted mean difference|0.16||||0.153|TWO_SIDED|95.0|-0.06|0.38|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Watery eyes treatment comparison at day 155||0.38|-0.06|0.153
70859358|NCT03101267|141205132|SUPERIORITY||Adjusted mean difference|0.12||||0.195|TWO_SIDED|95.0|-0.06|0.31|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Watery eyes treatment comparison at day 183||0.31|-0.06|0.195
70859359|NCT03101267|141205132|SUPERIORITY||Adjusted mean difference|0.2||||0.038|TWO_SIDED|95.0|0.01|0.38|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Watery eyes treatment comparison at day 183||0.38|0.01|0.038
70859360|NCT03101267|141205133|SUPERIORITY||Adjusted mean difference|0.37||||0.433|TWO_SIDED|95.0|-0.56|1.29|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||5TSS treatment comparison at day 127||1.29|-0.56|0.433
70859361|NCT03101267|141205133|SUPERIORITY||Adjusted mean difference|0.33||||0.479|TWO_SIDED|95.0|-0.59|1.24|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||5TSS treatment comparison at day 127||1.24|-0.59|0.479
70859362|NCT03101267|141205133|SUPERIORITY||Adjusted mean difference|0.22||||0.648|TWO_SIDED|95.0|-0.71|1.14|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||5TSS treatment comparison at day 155||1.14|-0.71|0.648
70859363|NCT03101267|141205133|SUPERIORITY||Adjusted mean difference|0.21||||0.654|TWO_SIDED|95.0|-0.72|1.14|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||5TSS treatment comparison at day 155||1.14|-0.72|0.654
70859364|NCT03101267|141205133|SUPERIORITY||Adjusted mean difference|0.27||||0.514|TWO_SIDED|95.0|-0.55|1.09|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||5TSS treatment comparison at day 183||1.09|-0.55|0.514
70859365|NCT03101267|141205133|SUPERIORITY||Adjusted mean difference|0.35||||0.4|TWO_SIDED|95.0|-0.47|1.17|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||5TSS treatment comparison at day 183||1.17|-0.47|0.400
70859366|NCT03101267|141205134|SUPERIORITY||Adjusted mean difference,|0.39||||0.505|TWO_SIDED|95.0|-0.76|1.54||The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.|MMRM|||6TSS treatment comparison at day 127||1.54|-0.76|0.505
70859367|NCT03101267|141205134|SUPERIORITY||Adjusted mean difference,|0.44||||0.451|TWO_SIDED|95.0|-0.71|1.58|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||6TSS treatment comparison at day 127||1.58|-0.71|0.451
70859368|NCT03101267|141205134|SUPERIORITY||Adjusted mean difference,|0.29||||0.623|TWO_SIDED|95.0|-0.88|1.46|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||6TSS treatment comparison at day 155||1.46|-0.88|0.623
71130293|NCT00265317|141764742|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.715||||0.1529|TWO_SIDED|95.0|0.38|1.344|||Log Rank|||Unmeasured EGFR Gene Amplification||1.344|0.380|0.1529
71130294|NCT00265317|141764744|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.6324|TWO_SIDED|95.0|0.516|2.608|||Log Rank|||Wild Type EGFR Gene Mutation||2.608|0.516|0.6324
71130295|NCT00265317|141764744|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.813||||0.2413|TWO_SIDED|95.0|0.464|1.424|||Log Rank|||Indeterminate EGFR Gene Mutation||1.424|0.464|0.2413
71130296|NCT00265317|141764746|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.481||||0.2077|TWO_SIDED|95.0|0.079|2.91|||Log Rank|||Mutated KRAS Gene Mutation||2.910|0.079|0.2077
71130297|NCT00265317|141764746|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.162||||0.6439|TWO_SIDED|95.0|0.534|2.531|||Log Rank|||Wild Type KRAS Gene Mutation||2.531|0.534|0.6439
71130298|NCT00265317|141764746|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.825||||0.2664|TWO_SIDED|95.0|0.457|1.489|||Log Rank|||Indeterminate KRAS Gene Mutation||1.489|0.457|0.2664
71130299|NCT00265317|141764748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.7423|TWO_SIDED|95.0|0.541|2.36||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: C/C||2.360|0.541|0.7423
71130300|NCT00265317|141764748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.598||||0.157|TWO_SIDED|95.0|0.29|1.236||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: C/T||1.236|0.290|0.1570
71130301|NCT00265317|141764748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.794||||0.7954|TWO_SIDED|95.0|0.131|4.819||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: T/T||4.819|0.131|0.7954
71130302|NCT00265317|141764748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.833||||0.621|TWO_SIDED|95.0|0.401|1.732||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305945 Genotype: G/G||1.732|0.401|0.6210
71130303|NCT00265317|141764748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.794||||0.5268|TWO_SIDED|95.0|0.385|1.64||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305945 Genotype: G/T||1.640|0.385|0.5268
71130304|NCT00265317|141764748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.011||||0.9753|TWO_SIDED|95.0|0.504|2.027||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1870377 Genotype: T/T||2.027|0.504|0.9753
71130305|NCT00265317|141764748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.378||||0.0141|TWO_SIDED|95.0|0.168|0.85||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1870377 Genotype: T/A||0.850|0.168|0.0141
71130306|NCT00265317|141764748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.236||||0.5596|TWO_SIDED|95.0|0.139|35.9||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1870377 Genotype: A/A||35.90|0.139|0.5596
71130307|NCT00265317|141764748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.738||||0.2788|TWO_SIDED|95.0|0.422|1.288||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305948 Genotype: C/C||1.288|0.422|0.2788
71130308|NCT00265317|141764748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.075||||0.8971|TWO_SIDED|95.0|0.352|3.286||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305948 Genotype: C/T||3.286|0.352|0.8971
71130309|NCT00265317|141764748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.775||||0.6559|TWO_SIDED|95.0|0.251|2.388||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: C/C||2.388|0.251|0.6559
71130310|NCT00265317|141764748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.939||||0.8563|TWO_SIDED|95.0|0.466|1.889||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: C/T||1.889|0.466|0.8563
71130311|NCT00265317|141764748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.382||||0.668|TWO_SIDED|95.0|0.13|1.12||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: T/T||1.120|0.130|0.668
71130312|NCT00265317|141764748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.3681|TWO_SIDED|95.0|0.488|1.309||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs35636987 Genotype: C/C||1.309|0.488|0.3681
71130313|NCT00265317|141764748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.752|TWO_SIDED|95.0|0.331|2.237||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: C/C||2.237|0.331|0.7520
71130314|NCT00265317|141764748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.551||||0.0833|TWO_SIDED|95.0|0.276|1.098||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: C/T||1.098|0.276|0.0833
71130315|NCT00265317|141764748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.564||||0.4772|TWO_SIDED|95.0|0.444|5.506||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: T/T||5.506|0.444|0.4772
71130316|NCT00265317|141764748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.034||||0.9235|TWO_SIDED|95.0|0.522|2.048||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: G/G||2.048|0.522|0.9235
71130317|NCT00265317|141764748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.501||||0.0845|TWO_SIDED|95.0|0.223|1.126||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: G/A||1.126|0.223|0.0845
71130318|NCT00265317|141764748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.724||||0.5493|TWO_SIDED|95.0|0.284|10.47||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: A/A||10.47|0.284|0.5493
71130319|NCT00265317|141764748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.521|TWO_SIDED|95.0|0.492|3.987||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: G/G||3.987|0.492|0.5210
71130320|NCT00265317|141764748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.538||||0.0854|TWO_SIDED|95.0|0.261|1.108||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: G/A||1.108|0.261|0.0854
71130321|NCT00265317|141764748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.953||||0.9198|TWO_SIDED|95.0|0.365|2.489||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: A/A||2.489|0.365|0.9198
71130322|NCT00265317|141764749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.977||||0.9486|TWO_SIDED|95.0|0.473|2.014||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: C/C||2.014|0.473|0.9486
71130323|NCT00265317|141764749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.961||||0.9084|TWO_SIDED|95.0|0.487|1.897||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: C/T||1.897|0.487|0.9084
71130324|NCT00265317|141764749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.876||||0.2009|TWO_SIDED|95.0|0.534|15.48||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: T/T||15.48|0.534|0.2009
71130325|NCT00265317|141764749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.098||||0.7863|TWO_SIDED|95.0|0.554|2.175||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305845 Genotype: G/G||2.175|0.554|0.7863
71130326|NCT00265317|141764749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.243||||0.5267|TWO_SIDED|95.0|0.633|2.442||2-sided unstratified log-rank test|Log Rank|||Locus: VEFR2/rs2305945 Genotype: G/T||2.442|0.633|0.5267
70859369|NCT03101267|141205134|SUPERIORITY||Adjusted mean difference,|0.29||||0.62|TWO_SIDED|95.0|-0.87|1.46|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||6TSS treatment comparison at day 155||1.46|-0.87|0.620
70859370|NCT03101267|141205134|SUPERIORITY||Adjusted mean difference,|0.35||||0.504|TWO_SIDED|95.0|-0.68|1.37|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||6TSS treatment comparison at day 183||1.37|-0.68|0.504
70859371|NCT03101267|141205134|SUPERIORITY||Adjusted mean difference,|0.42||||0.414|TWO_SIDED|95.0|-0.6|1.45|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||6TSS treatment comparison at day 183||1.45|-0.60|0.414
70859372|NCT01262352|141205146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.069||||0.0004|TWO_SIDED|95.0|-2.98|-1.15|||Mixed Models Analysis|||The primary analysis for the primary efficacy variable was based on a mixed effect model. The model included the absolute change from the baseline in each period as the dependent variable, sequence, treatment, and period as fixed effects, study baseline LCI as the covariate, and subject nested within sequence as the random effect.||-1.15|-2.98|0.0004
70859373|NCT01262352|141205147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.007||||0.0117|TWO_SIDED|95.0|1.8|12.21||P-value was not adjusted for multiple comparisons.|Mixed Models Analysis|||Analysis for this efficacy variable was performed in a similar way as the analysis for the primary efficacy variable.||12.21|1.80|0.0117
70859374|NCT01262352|141205148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-45.848|||<|0.0001|TWO_SIDED|95.0|-53.54|-38.16||P-value was not adjusted for multiple comparisons.|Mixed Models Analysis|||Analysis for change from baseline in average sweat chloride was similar to the analysis of the primary efficacy variable.||-38.16|-53.54|<0.0001
70859375|NCT01262352|141205149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.991||||0.3796|TWO_SIDED|95.0|-5.4|13.39||P-value was not adjusted for multiple comparisons.|Mixed Models Analysis|||The raw scores in CFQ-R were summarized into different domains of health (12 domains for adolescents and adults 14 years of age and older, 8 domains for children ages 12 and 13 years, 8 domains for children ages 6 to 11 years, and 11 domains for parents/caregivers). Each domain was analyzed in a similar way as for the primary efficacy variable. The primary analytical focus was the respiratory health domain which was analyzed by combining all self-response questionnaire versions.||13.39|-5.40|0.3796
70859376|NCT00591578|141205232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.64|||<|0.001|TWO_SIDED|95.0|-5.59|-1.69||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-1.69|-5.59|<0.001
70859377|NCT00591578|141205232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.03|||<|0.001|TWO_SIDED|95.0|-6.01|-2.06||Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-2.06|-6.01|<0.001
70859378|NCT00591578|141205233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.27||||0.015|TWO_SIDED|95.0|-5.9|-0.63||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.63|-5.90|0.015
70859379|NCT00591578|141205233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.34|||<|0.001|TWO_SIDED|95.0|-8.0|-2.68||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-2.68|-8.00|<0.001
70859380|NCT00591578|141205234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.16|||<|0.001|TWO_SIDED|95.0|-3.44|-0.88||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.88|-3.44|<0.001
70859381|NCT00591578|141205234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.69|||<|0.001|TWO_SIDED|95.0|-3.99|-1.4||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.40|-3.99|<0.001
70859382|NCT00591578|141205235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.52||||0.001|TWO_SIDED|95.0|-4.06|-0.98||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.98|-4.06|0.001
70859383|NCT00591578|141205235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.76|||<|0.001|TWO_SIDED|95.0|-4.32|-1.21||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.21|-4.32|<0.001
70859384|NCT00591578|141205236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.49|||<|0.001|TWO_SIDED|95.0|-5.53|-1.44||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.44|-5.53|<0.001
70859385|NCT00591578|141205236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|||<|0.001|TWO_SIDED|95.0|-5.96|-1.83||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.83|-5.96|<0.001
70859386|NCT00591578|141205237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.17||||0.002|TWO_SIDED|95.0|-3.54|-0.79||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.79|-3.54|0.002
70859387|NCT00591578|141205237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.67|||<|0.001|TWO_SIDED|95.0|-4.06|-1.28||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.28|-4.06|<0.001
70859388|NCT00591578|141205238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.79|||<|0.001|TWO_SIDED|95.0|-5.96|-1.62||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.62|-5.96|<0.001
70859389|NCT00591578|141205238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.44|||<|0.001|TWO_SIDED|95.0|-6.63|-2.24||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-2.24|-6.63|<0.001
71130327|NCT00265317|141764749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55||||0.624|TWO_SIDED|95.0|0.049|6.208||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305945 Genotype: T/T||6.208|0.049|0.6240
70946965|NCT03599622|141394101|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|1.4||||0.3464|TWO_SIDED|95.0|0.7|2.8||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||2.8|0.7|0.3464
71130328|NCT00265317|141764749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.254||||0.4882|TWO_SIDED|95.0|0.66|2.384||2-sided unstratified log-rank test|Log Rank|||Locus: VEFR/rs1870377 Genotype: T/T||2.384|0.660|0.4882
71130329|NCT00265317|141764749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.587||||0.1307|TWO_SIDED|95.0|0.29|1.189||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1870377 Genotype: T/A||1.189|0.290|0.1307
71130330|NCT00265317|141764749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.236||||0.5596|TWO_SIDED|95.0|0.139|35.9||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1870377 Genotype: A/A||35.90|0.139|0.5596
71130331|NCT00265317|141764749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.073||||0.7966|TWO_SIDED|95.0|0.628|1.833||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305948 Genotype: C/C||1.833|0.628|0.7966
71130332|NCT00265317|141764749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.954||||0.9224|TWO_SIDED|95.0|0.366|2.484||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305948 Genotype: C/T||2.484|0.366|0.9224
71130333|NCT00265317|141764749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.047||||0.9317|TWO_SIDED|95.0|0.363|3.025||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: C/C||3.025|0.363|0.9317
71130334|NCT00265317|141764749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.057||||0.8696|TWO_SIDED|95.0|0.546|2.044||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: C/T||2.044|0.546|0.8696
71130335|NCT00265317|141764749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.075||||0.8694|TWO_SIDED|95.0|0.453|2.554||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: T/T||2.554|0.453|0.8694
71130336|NCT00265317|141764749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.039||||0.8708|TWO_SIDED|95.0|0.654|1.652||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs3563987 Genotype: C/C||1.652|0.654|0.8708
71130337|NCT00265317|141764749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.157||||0.7667|TWO_SIDED|95.0|0.442|3.026||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: C/C||3.026|0.442|0.7667
71130338|NCT00265317|141764749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.755||||0.3822|TWO_SIDED|95.0|0.401|1.422||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: C/T||1.422|0.401|0.3822
71130339|NCT00265317|141764749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.419||||0.5089|TWO_SIDED|95.0|0.498|4.04||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: T/T||4.040|0.498|0.5089
71130340|NCT00265317|141764749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.326||||0.3944|TWO_SIDED|95.0|0.691|2.544||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: G/G||2.544|0.691|0.3944
71130341|NCT00265317|141764749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.692||||0.3103|TWO_SIDED|95.0|0.339|1.416||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: G/A||1.416|0.339|0.3103
71130342|NCT00265317|141764749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.857||||0.8942|TWO_SIDED|95.0|0.089|8.294||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: A/A||8.294|0.089|0.8942
71130343|NCT00265317|141764749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||0.665|TWO_SIDED|95.0|0.466|3.304||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: G/G||3.304|0.466|0.6650
71130344|NCT00265317|141764749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.779||||0.4415|TWO_SIDED|95.0|0.412|1.475||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: G/A||1.475|0.412|0.4415
71130345|NCT00265317|141764749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.458||||0.4682|TWO_SIDED|95.0|0.523|4.06||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: A/A||4.060|0.523|0.4682
71130346|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.289||||0.7301|TWO_SIDED|95.0|0.304|5.47||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304060 Genotype: C/C||5.470|0.304|0.7301
71130347|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.788||||0.5013|TWO_SIDED|95.0|0.39|1.592||2-sided unstratified log-rank test|Log Rank|||PDGFRB/rs2304060 C/A||1.592|0.390|0.5013
71130348|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.686||||0.368|TWO_SIDED|95.0|0.298|1.578||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304060 Genotype: A/A||1.578|0.298|0.3680
71130349|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.738||||0.3804|TWO_SIDED|95.0|0.371|1.467||2-sided, unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17656204 Genotype: C/C||1.467|0.371|0.3804
71130350|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.1507|TWO_SIDED|95.0|0.261|1.247||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17656204 Genotype: C/T||1.247|0.261|0.1507
71130351|NCT00265317|141764751|SUPERIORITY_OR_OTHER|||||||0.0772||||||2-sided unstratified log-rank test|Log Rank|||Locus PDGFRB/rs17656204 Genotype: T/T||||0.0772
71130352|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.2149|TWO_SIDED|95.0|0.339|1.284||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304061 Genotype: G/G||1.284|0.339|0.2149
71130353|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.026||||0.9491|TWO_SIDED|95.0|0.466|2.26||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/RS2304061 Genotype: G/A||2.260|0.466|0.9491
71130354|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.917||||0.8114|TWO_SIDED|95.0|0.447|1.881||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: A/A||1.881|0.447|0.8114
70859390|NCT00591578|141205239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.008|TWO_SIDED|95.0|-3.48|-0.53||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.53|-3.48|0.008
70859391|NCT00591578|141205239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.84|||<|0.001|TWO_SIDED|95.0|-4.33|-1.35||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.35|-4.33|<0.001
70859392|NCT00591578|141205240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.44||||0.002|TWO_SIDED|95.0|-5.57|-1.3||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.30|-5.57|0.002
70859393|NCT00591578|141205240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.01|||<|0.001|TWO_SIDED|95.0|-6.16|-1.85||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.85|-6.16|<0.001
70859394|NCT00591578|141205241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.18||||0.003|TWO_SIDED|95.0|-3.63|-0.72||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.72|-3.63|0.003
70859395|NCT00591578|141205241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.73|||<|0.001|TWO_SIDED|95.0|-4.2|-1.25||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.25|-4.20|<0.001
70859396|NCT00591578|141205242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.38||||0.005|TWO_SIDED|95.0|-5.76|-1.0||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.00|-5.76|0.005
70859397|NCT00591578|141205242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47||||0.005|TWO_SIDED|95.0|-5.87|-1.06||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.06|-5.87|0.005
70859398|NCT00591578|141205243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.31||||0.009|TWO_SIDED|95.0|-4.04|-0.59||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.59|-4.04|0.009
70859399|NCT00591578|141205243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.59||||0.004|TWO_SIDED|95.0|-4.34|-0.84||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.84|-4.34|0.004
70859400|NCT00591578|141205244|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.016|TWO_SIDED|95.0|1.07|2.0||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.||||2.00|1.07|0.016
70859401|NCT00591578|141205244|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63||||0.002|TWO_SIDED|95.0|1.19|2.23||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.||||2.23|1.19|0.002
70859402|NCT00591578|141205245|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.041|TWO_SIDED|95.0|1.02|2.1||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.||||2.10|1.02|0.041
70859403|NCT00591578|141205245|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.015|TWO_SIDED|95.0|1.09|2.28||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.||||2.28|1.09|0.015
70859404|NCT00591578|141205246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.018|TWO_SIDED|95.0|1.07|1.99||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.||||1.99|1.07|0.018
70859405|NCT00591578|141205246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.24|2.33||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.||||2.33|1.24|<0.001
71130355|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.577||||0.1379|TWO_SIDED|95.0|0.273|1.221||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: A/T||1.221|0.273|0.1379
71130356|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.859||||0.5341|TWO_SIDED|95.0|0.256|13.51||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: T/T||13.51|0.256|0.5341
71130357|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.932||||0.8564|TWO_SIDED|95.0|0.431|2.014||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: A/A||2.014|0.431|0.8564
71130358|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.797||||0.5766|TWO_SIDED|95.0|0.355|1.788||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: A/G||1.788|0.355|0.5766
71130359|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.467||||0.2043|TWO_SIDED|95.0|0.14|1.557||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: G/G||1.557|0.140|0.2043
71130360|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.531||||0.1626|TWO_SIDED|95.0|0.214|1.317||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: G/G||1.317|0.214|0.1626
71130361|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.986||||0.968|TWO_SIDED|95.0|0.484|2.006||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: G/C||2.006|0.484|0.9680
70946966|NCT03599622|141394101|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|-1.2||||0.8857|TWO_SIDED|95.0|-17.0|14.7||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||14.7|-17.0|0.8857
71130362|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.573||||0.3587|TWO_SIDED|95.0|0.171|1.92||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: C/C||1.920|0.171|0.3587
70859406|NCT05038904|141205339|SUPERIORITY|We estimated that 10 subjects allowed for 80% power to detect a 3-fold increase (1.1 natural log units; i.e. 1 food dose escalation) in the threshold food dose using a paired t test with p\<0.05. For this sample size determination, the primary endpoint was assumed to be normally distributed with a standard deviation of 1.1 natural log units.||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
70859407|NCT05038904|141205340|SUPERIORITY|||||||0.0014|||||||t-test, 2 sided|||||||0.0014
70859408|NCT05038904|141205341|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
70946967|NCT03599622|141394101|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|1.0||||0.8857|TWO_SIDED|95.0|0.5|1.9||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||1.9|0.5|0.8857
71130363|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.742||||0.4635|TWO_SIDED|95.0|0.331|1.662||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: G/G||1.662|0.331|0.4635
70859409|NCT05038904|141205342|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Participants' ex vivo basophil activation during acalabrutinib treatment was compared to their own baseline level.||||0.002
70859410|NCT02730208|141205429|OTHER|Treatment effect outcomes are estimates.|Least Squares (LS) Mean Difference|-1.48|||||TWO_SIDED|95.0|-7.47|4.52||||||||4.52|-7.47|
71130364|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.992||||0.9834|TWO_SIDED|95.0|0.476|2.069||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: G/A||2.069|0.476|0.9834
71130365|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.353||||0.1764|TWO_SIDED|95.0|0.072|1.725||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: A/A||1.725|0.072|0.1764
71130366|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.715||||0.2018|TWO_SIDED|95.0|0.422|1.209||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3733678 Genotype: G/G||1.209|0.422|0.2018
71130367|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.85||||0.4592|TWO_SIDED|95.0|0.354|9.673||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3733678 Genotype: G/A||9.673|0.354|0.4592
71130368|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.665||||0.1593|TWO_SIDED|95.0|0.373|1.184||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs246396 Genotype: T/T||1.184|0.373|0.1593
71130369|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.327||||0.5897|TWO_SIDED|95.0|0.469|3.755||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs246396 Genotype: T/C||3.755|0.469|0.5897
70946968|NCT03599622|141394102|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|8.1||||0.2841|TWO_SIDED|95.0|-6.7|22.9||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||22.9|-6.7|0.2841
71130370|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.3681|TWO_SIDED|95.0|0.488|1.309||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs34586048 Genotype: C/C||1.309|0.488|0.3681
71130371|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.752||||0.3235|TWO_SIDED|95.0|0.423|1.336||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs11740355 Genotype: T/T||1.336|0.423|0.3235
71130372|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.845||||0.7463|TWO_SIDED|95.0|0.303|2.355||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs11740355 Genotype: T/G||2.355|0.303|0.7463
71130373|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.724||||0.4179|TWO_SIDED|95.0|0.33|1.593||2-sided unstratified log-rank test|Log Rank|||Locus: rs740751 Genotype: C/C||1.593|0.330|0.4179
71130374|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.973||||0.9423|TWO_SIDED|95.0|0.462|2.05||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs740751 Genotype: C/T||2.050|0.462|0.9423
71130375|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.353||||0.1764|TWO_SIDED|95.0|0.072|1.725||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs7407451 Genotype: T/T||1.725|0.072|0.1764
71130376|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.549||||0.2352|TWO_SIDED|95.0|0.201|1.501||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: G/G||1.501|0.201|0.2352
71130377|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.986||||0.9674|TWO_SIDED|95.0|0.485|2.003||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: G/A||2.003|0.485|0.9674
71130378|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.629||||0.3524|TWO_SIDED|95.0|0.235|1.686||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: A/A||1.686|0.235|0.3524
71130379|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.809||||0.6652|TWO_SIDED|95.0|0.308|2.124||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: T/T||2.124|0.308|0.6652
71130380|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.839||||0.5931|TWO_SIDED|95.0|0.436|1.618||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: T/G||1.618|0.436|0.5931
71130381|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.475||||0.2625|TWO_SIDED|95.0|0.125|1.813||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: G/G||1.813|0.125|0.2625
71130382|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.704||||0.2168|TWO_SIDED|95.0|0.4|1.239||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17708574 Genotype: G/G||1.239|0.400|0.2168
71130383|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.987||||0.9802|TWO_SIDED|95.0|0.353|2.759||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17708574 Genotype: G/A||2.759|0.353|0.9802
71130384|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.652||||0.1145|TWO_SIDED|95.0|0.378|1.122||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs10063714 Genotype: T/T||1.122|0.378|0.1145
71130385|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.192||||0.7725|TWO_SIDED|95.0|0.36|3.946||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs10063714 Genotype: T/A||3.946|0.360|0.7725
71130386|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.687||||0.3286|TWO_SIDED|95.0|0.321|1.473||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: A/A||1.473|0.321|0.3286
71130387|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.976||||0.948|TWO_SIDED|95.0|0.47|2.028||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: A/G||2.028|0.470|0.9480
71130388|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.531||||0.3844|TWO_SIDED|95.0|0.125|2.282||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: G/G||2.282|0.125|0.3844
71130389|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.662||||0.1373|TWO_SIDED|95.0|0.381|1.153||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2007637 Genotype: G/G||1.153|0.381|0.1373
71130390|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.114||||0.8586|TWO_SIDED|95.0|0.339|3.667||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2007637 Genotype: G/A||3.667|0.339|0.8586
71130391|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.935||||0.8478|TWO_SIDED|95.0|0.47|1.861||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: G/G||1.861|0.470|0.8478
71130392|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.634||||0.2445|TWO_SIDED|95.0|0.287|1.401||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: G/A||1.401|0.287|0.2445
71130393|NCT00265317|141764751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.155||||0.9191|TWO_SIDED|95.0|0.072|18.59||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: A/A||18.59|0.072|0.9191
71130394|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.121||||0.8563|TWO_SIDED|95.0|0.326|3.847||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304060 Genotype: C/C||3.847|0.326|0.8563
71130395|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.111||||0.7375|TWO_SIDED|95.0|0.599|2.064||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304060 Genotype: C/A||2.064|0.599|0.7375
71130396|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.897||||0.8066|TWO_SIDED|95.0|0.375|2.147||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs234060 Genotype: A/A||2.147|0.375|0.8066
70859411|NCT00245219|141205431|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
70859412|NCT00245219|141205431|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the education condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
70859413|NCT00245219|141205431|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
70859414|NCT00245219|141205431|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the education condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
70859415|NCT00245219|141205431|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and control condition at Time 2, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
70859416|NCT00245219|141205431|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and control condition at Time 3, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
70859417|NCT00245219|141205431|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The interaction between the peer support condition and cancer stage at Time 2. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
70859418|NCT00245219|141205431|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The interaction between the peer support condition and cancer stage at Time 3. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
70859419|NCT00245219|141205432|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
70859420|NCT00245219|141205432|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the education condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
70859421|NCT00245219|141205432|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
70859422|NCT00245219|141205432|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the education condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
70946969|NCT03599622|141394102|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|1.5||||0.2841|TWO_SIDED|95.0|0.7|3.1||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||3.1|0.7|0.2841
71130397|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.875||||0.6945|TWO_SIDED|95.0|0.449|1.708||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17656204 Genotype: C/C||1.708|0.449|0.6945
71130398|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.067||||0.8536|TWO_SIDED|95.0|0.536|2.122||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17656204 Genotype: C/T||2.122|0.536|0.8536
71130399|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.732||||0.3657|TWO_SIDED|95.0|0.283|26.42||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17656204 Genotype: T/T||26.42|0.283|0.3657
71130400|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.793||||0.4657|TWO_SIDED|95.0|0.424|1.483||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304061 Genotype: G/G||1.483|0.424|0.4657
71130401|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.364||||0.4168|TWO_SIDED|95.0|0.641|2.9||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304061 Genotype: G/A||2.900|0.641|0.4168
71130402|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.908||||0.7836|TWO_SIDED|95.0|0.456|1.809||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: A/A||1.809|0.456|0.7836
71130403|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.938||||0.8531|TWO_SIDED|95.0|0.472|1.863||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: A/T||1.863|0.472|0.8531
71130404|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.32||||0.3272|TWO_SIDED|95.0|0.412|13.07||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: T/T||13.07|0.412|0.3272
71130405|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.984||||0.963|TWO_SIDED|95.0|0.491|1.972||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: A/A||1.972|0.491|0.9630
71130406|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.227||||0.6003|TWO_SIDED|95.0|0.567|2.656||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: A/G||2.656|0.567|0.6003
71130407|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.769||||0.6703|TWO_SIDED|95.0|0.229|2.58||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: G/G||2.580|0.229|0.6703
71130408|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.106||||0.81|TWO_SIDED|95.0|0.485|2.525||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: G/G||2.525|0.485|0.8100
71130409|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.076||||0.8335|TWO_SIDED|95.0|0.541|2.141||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: G/C||2.141|0.541|0.8335
71130410|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.758||||0.598|TWO_SIDED|95.0|0.268|2.141||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: C/C||2.141|0.268|0.5980
71130411|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.035||||0.9287|TWO_SIDED|95.0|0.487|2.199||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: G/G||2.199|0.487|0.9287
71130412|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.053||||0.8842|TWO_SIDED|95.0|0.526|2.106||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: G/A||2.106|0.526|0.8842
71130413|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.129||||0.8501|TWO_SIDED|95.0|0.316|4.028||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: A/A||4.028|0.316|0.8501
71130414|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.229||||0.4118|TWO_SIDED|95.0|0.749|2.017||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3733678 Genotype: G/G||2.017|0.749|0.4118
71130415|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.286||||0.1299|TWO_SIDED|95.0|0.051|1.596||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3733678 Genotype: G/A||1.596|0.051|0.1299
71130416|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.692||||0.1859|TWO_SIDED|95.0|0.399|1.2||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs246396 Genotype: T/T||1.200|0.399|0.1859
71130417|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.672||||0.0091|TWO_SIDED|95.0|1.291|10.44||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs246396 Genotype: T/C||10.44|1.291|0.0091
71130418|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.039||||0.8708|TWO_SIDED|95.0|0.654|1.652||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs34586048 Genotype: C/C||1.652|0.654|0.8708
71130419|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.996||||0.9888|TWO_SIDED|95.0|0.59|1.681||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs11740355 Genotype: T/T||1.681|0.590|0.9888
71130420|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.9702|TWO_SIDED|95.0|0.36|2.891||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs11740355 Genotype: T/G||2.891|0.360|0.9702
71130421|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.973||||0.9419|TWO_SIDED|95.0|0.466|2.032||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs740751 Genotype: C/C||2.032|0.466|0.9419
70946970|NCT03599622|141394102|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|-4.2||||0.5417|TWO_SIDED|95.0|-17.6|9.2||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||9.2|-17.6|0.5417
70946971|NCT03599622|141394102|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|0.8||||0.5417|TWO_SIDED|95.0|0.3|1.8||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||1.8|0.3|0.5417
70946972|NCT03599622|141394103|EQUIVALENCE|Mean Change From Baseline|Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|95.0|-4.3|-1.8|||ANCOVA|||||-1.8|-4.3|
70946973|NCT03599622|141394103|SUPERIORITY|Adjusted means, 95% confidence intervals, and p-values are from an analysis of covariance model with factors for geographic region, prior exposure to tumor necrosis factor inhibitor, and concomitant corticosteroid use, and the baseline value as a covariate.|Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.92||0.0428|TWO_SIDED|95.0|-3.7|-0.1||Based on a 2-sided test at a significance level of 0.025.|ANCOVA||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||-0.1|-3.7|0.0428
70946974|NCT03599622|141394103|EQUIVALENCE|Mean Change from Baseline|Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-4.8|-2.0|||ANCOVA|||||-2.0|-4.8|
71130422|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.112||||0.7677|TWO_SIDED|95.0|0.549|2.252||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs740751 Genotype: C/T||2.252|0.549|0.7677
71130423|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.129||||0.8501|TWO_SIDED|95.0|0.316|4.028||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs740751 Genotype: T/T||4.028|0.316|0.8501
71130424|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.758||||0.5233|TWO_SIDED|95.0|0.322|1.782||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: G/G||1.782|0.322|0.5233
71130425|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.123||||0.75|TWO_SIDED|95.0|0.549|2.297||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: G/A||2.297|0.549|0.7500
71130426|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.232||||0.6614|TWO_SIDED|95.0|0.483|3.142||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: A/A||3.142|0.483|0.6614
71130427|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.779||||0.2552|TWO_SIDED|95.0|0.652|4.855||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: T/T||4.855|0.652|0.2552
71130428|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.088||||0.7931|TWO_SIDED|95.0|0.577|2.052||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: T/G||2.052|0.577|0.7931
71130429|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.449||||0.1365|TWO_SIDED|95.0|0.152|1.331||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: G/G||1.331|0.152|0.1365
71130430|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.854||||0.5544|TWO_SIDED|95.0|0.504|1.447||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17708574 Genotype: G/G||1.447|0.504|0.5544
71130431|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.721||||0.3132|TWO_SIDED|95.0|0.59|5.021||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17708574 Genotype: G/A||5.021|0.590|0.3132
71130432|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.263||||0.3698|TWO_SIDED|95.0|0.755|2.113||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs10063714 Genotype: T/T||2.113|0.755|0.3698
71130433|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.411||||0.1495|TWO_SIDED|95.0|0.119|1.423||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs10063714 Genotype: T/A||1.423|0.119|0.1495
71130434|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.613||||0.1911|TWO_SIDED|95.0|0.781|3.332||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: A/A||3.332|0.781|0.1911
71130435|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.793||||0.5259|TWO_SIDED|95.0|0.384|1.636||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: A/G||1.636|0.384|0.5259
71130436|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.331||||0.0996|TWO_SIDED|95.0|0.082|1.339||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: G/G||1.339|0.082|0.0996
71130437|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.752||||0.2755|TWO_SIDED|95.0|0.45|1.259||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2007637 Genotype: G/G||1.259|0.450|0.2755
71130438|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.85||||0.012|TWO_SIDED|95.0|1.253|18.78||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2007637 Genotype: G/A||18.78|1.253|0.0120
71130439|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.274||||0.4663|TWO_SIDED|95.0|0.661|2.457||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: G/G||2.457|0.661|0.4663
71130440|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.867||||0.7097|TWO_SIDED|95.0|0.406|1.848||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: G/A||1.848|0.406|0.7097
71130441|NCT00265317|141764752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.607||||0.534|TWO_SIDED|95.0|0.117|3.158||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: A/A||3.158|0.117|0.5340
71130442|NCT00265317|141764755|SUPERIORITY_OR_OTHER|||||||0.2702|||||||Wilcoxon Rank Sum Test|||VEGF-C Ratio to Baseline for Cycle 2, Day 1||||0.2702
71130443|NCT00265317|141764755|SUPERIORITY_OR_OTHER|||||||0.7354||95.0|||||Wilcoxon Rank Sum Test|||VEGF-C ratio to Baseline for Cycle 3, Day 1||||0.7354
71130444|NCT00265317|141764757|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum Test|||VEGFR-2 Ratio to Baseline for Cycle 2, Day 1||||<0.0001
71130445|NCT00265317|141764757|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon Rank Sum Test|||VEGFR-2 Ratio to Baseline for Cycle 3, Day 1||||<0.0001
70946975|NCT03599622|141394103|SUPERIORITY|Adjusted means, 95% confidence intervals, and p-values are from an analysis of covariance model with factors for geographic region, prior exposure to tumor necrosis factor inhibitor, and concomitant corticosteroid use, and the baseline value as a covariate.|Mean Difference (Final Values)|-2.3|STANDARD_ERROR_OF_MEAN|0.95||0.0177|TWO_SIDED|95.0|-4.1|-0.4||Based on a 2-sided test at a significance level of 0.025.|ANCOVA||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||-0.4|-4.1|0.0177
71130446|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.553||||0.1667|TWO_SIDED|95.0|0.159|1.921||1-sided unstratified log-rank test|Log Rank|||High CSF-1R expression||1.921|0.159|0.1667
71130447|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.451||||0.7688|TWO_SIDED|95.0|0.534|3.944||1-sided unstratified log-rank test|Log Rank|||Low CSF-1R expression||3.944|0.534|0.7688
71130448|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.3498|TWO_SIDED|95.0|0.503|1.574||1-sided unstratified log-rank test|Log Rank|||Indeterminate CSF-1R expression||1.574|0.503|0.3498
71130449|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.687||||0.9497|TWO_SIDED|95.0|0.79|9.143||1-sided unstratified log-rank test|Log Rank|||High PDGFRalpha expression||9.143|0.790|0.9497
71130450|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.386||||0.0401|TWO_SIDED|95.0|0.127|1.173||1-sided unstratified log-rank test|Log Rank|||Low PDGFRalpha expression||1.173|0.127|0.0401
71130451|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.862||||0.3128|TWO_SIDED|95.0|0.487|1.524||1-sided unstratified log-rank test|Log Rank|||Indeterminate PDGFRalpha expression||1.524|0.487|0.3128
71130452|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.823||||0.365|TWO_SIDED|95.0|0.273|2.488||1-sided unstratified log-rank test|Log Rank|||High PDGFRbeta expression||2.488|0.273|0.3650
71130453|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.192||||0.6105|TWO_SIDED|95.0|0.408|3.48||1-sided unstratified log-rank test|Log Rank|||Low PDGFRbeta expression||3.480|0.408|0.6105
71130454|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.856||||0.3027|TWO_SIDED|95.0|0.488|1.502||1-sided unstratified log-rank test|Log Rank|||Indeterminate PDGFRbeta expression||1.502|0.488|0.3027
71130455|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.914||||0.4436|TWO_SIDED|95.0|0.262|3.184||1-sided unstratified log-rank test|Log Rank|||High VEGF expression||3.184|0.262|0.4436
71130456|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.953||||0.4582|TWO_SIDED|95.0|0.296|3.062||1-sided unstratified log-rank test|Log Rank|||Low VEGF expression||3.062|0.296|0.4582
71130457|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.911||||0.372|TWO_SIDED|95.0|0.536|1.548||1-sided unstratified log-rank test|Log Rank|||Indeterminate VEGF expression||1.548|0.536|0.3720
71130458|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.5586|TWO_SIDED|95.0|0.35|3.397||1-sided unstratified log-rank test|Log Rank|||High VEGF-C expression||3.397|0.350|0.5586
71130459|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.842||||0.3652|TWO_SIDED|95.0|0.313|2.266||1-sided unstratified log-rank test|Log Rank|||Low VEGF-C expression||2.266|0.313|0.3652
71130460|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.875||||0.3301|TWO_SIDED|95.0|0.493|1.554||1-sided unstratified log-rank test|Log Rank|||Indeterminate VEGF-C expression||1.554|0.493|0.3301
71130461|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.097||||0.5605|TWO_SIDED|95.0|0.331|3.636||1-sided unstratified log-rank test|Log Rank|||High VEGFR1 expression||3.636|0.331|0.5605
71130462|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.599||||0.2132|TWO_SIDED|95.0|0.16|2.236||1-sided unstratified log-rank test|Log Rank|||Low VEGFR1 expression||2.236|0.160|0.2132
71130463|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.902||||0.3605|TWO_SIDED|95.0|0.53|1.537||1-sided unstratified log-rank test|Log Rank|||Indeterminate VEGFR1 expression||1.537|0.530|0.3605
71130464|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.921||||0.4438|TWO_SIDED|95.0|0.304|2.784||1-sided unstratified log-rank test|Log Rank|||High VEGFR2 expression||2.784|0.304|0.4438
71130465|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.122||||0.5699|TWO_SIDED|95.0|0.403|3.125||1-sided unstratified log-rank test|Log Rank|||Low VEGFR2 expression||3.125|0.403|0.5699
71130466|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.864||||0.3147|TWO_SIDED|95.0|0.489|1.528||1-sided unstratified log-rank test|Log Rank|||Indeterminate VEGFR2 expression||1.528|0.489|0.3147
71130467|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.002||||0.5015|TWO_SIDED|95.0|0.281|3.581||1-sided unstratified log-rank test|Log Rank|||High VEGFR3 expression||3.581|0.281|0.5015
71130468|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.005||||0.4887|TWO_SIDED|95.0|0.334|3.025||1-sided unstratified log-rank test|Log Rank|||Low VEGFR3 expression||3.025|0.334|0.4887
71130469|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.818||||0.2432|TWO_SIDED|95.0|0.473|1.414||1-sided unstratified log-rank test|Log Rank|||Indeterminate VEGFR3 expression||1.414|0.473|0.2432
71130470|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.446||||0.2321|TWO_SIDED|95.0|0.048|4.101||1-sided unstratified log-rank test|Log Rank|||Detected FGF expression||4.101|0.048|0.2321
71130471|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.316||||0.7143|TWO_SIDED|95.0|0.526|3.292||1-sided unstratified log-rank test|Log Rank|||No detected FGF expression||3.292|0.526|0.7143
71130472|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.844||||0.2812|TWO_SIDED|95.0|0.486|1.465||1-sided unstratified log-rank test|Log Rank|||Indeterminate FGF expression||1.465|0.486|0.2812
71130473|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.406||||0.6504|TWO_SIDED|95.0|0.248|7.96||1-sided unstratified log-rank test|Log Rank|||Detected FLT3 expression||7.960|0.248|0.6504
71130474|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.838||||0.3266|TWO_SIDED|95.0|0.375|1.876||1-sided unstratified log-rank test|Log Rank|||No detected FLT3 expression||1.876|0.375|0.3266
71130475|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.896||||0.3597|TWO_SIDED|95.0|0.502|1.598||1-sided unstratified log-rank test|Log Rank|||Indeterminate FLT3 expression||1.598|0.502|0.3597
71130476|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.342||||0.6907|TWO_SIDED|95.0|0.419|4.297||1-sided unstratified log-rank test|Log Rank|||Detected KIT expression||4.297|0.419|0.6907
70946976|NCT03599622|141394103|EQUIVALENCE|Mean Change From Baseline|Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-2.6|0.3||||||||0.3|-2.6|
71130477|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.677||||0.199|TWO_SIDED|95.0|0.265|1.731||1-sided unstratified log-rank test|Log Rank|||Participants with no detected KIT expression||1.731|0.265|0.1990
71130478|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.896||||0.3597|TWO_SIDED|95.0|0.502|1.598||1-sided unstratified log-rank test|Log Rank|||Indeterminate KIT expression||1.598|0.502|0.3597
70859423|NCT00245219|141205432|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and control condition at Time 2, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
70859424|NCT00245219|141205432|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The interaction between the peer support condition and breast cancer stage at Time 2. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
70946977|NCT03599622|141394103|EQUIVALENCE|Mean Change from Baseline|Mean Difference (Final Values)|-6.0|STANDARD_ERROR_OF_MEAN|1.88|||TWO_SIDED|95.0|-9.7|-2.3|||ANCOVA|||||-2.3|-9.7|
71130479|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.693||||0.3757|TWO_SIDED|95.0|0.071|6.765||1-sided unstratified log-rank test|Log Rank|||Detected RET expression||6.765|0.071|0.3757
70946978|NCT01130168|141394122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.1|||<|0.0005|TWO_SIDED|95.0|-15.3|-10.9|||ANOVA|||||-10.9|-15.3|<0.0005
70946979|NCT01130168|141394122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.016|TWO_SIDED|95.0|-4.9|-0.6|||ANOVA|||||-0.6|-4.9|0.016
71130480|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.874||||0.3723|TWO_SIDED|95.0|0.358|2.13||1-sided unstratified log-rank test|Log Rank|||No detected RET expression||2.130|0.358|0.3723
71130481|NCT00265317|141764758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.874||||0.3263|TWO_SIDED|95.0|0.501|1.523||1-sided unstratified log-rank test|Log Rank|||Indeterminate RET expression||1.523|0.501|0.3263
71130482|NCT00265317|141764759|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum Test|||VEGFR-3 Ratio to Baseline for Cycle 2, Day 1||||<0.0001
71130483|NCT00265317|141764759|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon Rank Sum Test|||VEGFR-3 Ratio to Baseline for Cycle 3, Day 1||||<0.0001
71130484|NCT00265317|141764761|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum Test|||sKIT Ratio to Baseline for Cycle 2, Day 1||||<0.0001
71130485|NCT00265317|141764761|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon Rank Sum Test|||sKIT Ratio to Baseline for Cycle 3, Day 1||||<0.0001
71130486|NCT00265317|141764766|SUPERIORITY_OR_OTHER|||||||0.3681||95.0||||2-sided normal approximated p-value|Wilcoxon Rank Sum Test|||||||0.3681
71130487|NCT00265317|141764767|SUPERIORITY_OR_OTHER|||||||0.5982||95.0||||2-sided normal approximated p-value|Wilcoxon Rank Sum Test|||||||0.5982
70859425|NCT00245219|141205432|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and control condition at Time 3, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
70859426|NCT00245219|141205432|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The interaction between the peer support condition and breast cancer stage at Time 3. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
70859427|NCT00245219|141205433|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The comparison between the peer support condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
70859428|NCT00245219|141205433|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The comparison between the education condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
71130488|NCT00265317|141764768|SUPERIORITY_OR_OTHER|||||||0.9807||95.0||||2-sided normal approximated p-value|Wilcoxon Rank Sum Test|||||||0.9807
70859429|NCT00245219|141205433|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The comparison between the peer support condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
70859430|NCT00245219|141205433|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The comparison between the education condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
70859431|NCT00245219|141205433|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The comparison between the peer support condition and control condition at Time 2, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
70946980|NCT01130168|141394123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.407|TWO_SIDED|95.0|-1.7|4.3|||ANOVA|||||4.3|-1.7|0.407
70859432|NCT00245219|141205433|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The interaction between the peer support condition and breast cancer stage at Time 2. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
70859433|NCT00245219|141205433|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The comparison between the peer support condition and control condition at Time 3, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
70859434|NCT00245219|141205433|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The interaction between the peer support condition and breast cancer stage at Time 3. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
70946981|NCT01130168|141394123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|||<|0.0005|TWO_SIDED|95.0|-8.9|-2.9|||ANOVA|||||-2.9|-8.9|<0.0005
70946982|NCT01130168|141394124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.4|||<|0.0005|TWO_SIDED|95.0|-21.2|-10.1|||ANOVA|||||-10.1|-21.2|<0.0005
71130489|NCT00265317|141764769|SUPERIORITY_OR_OTHER|||||||0.3945||||||2-sided normal approximated p-value|Wilcoxon Rank Sum Test|||||||0.3945
71130490|NCT02510001|141764770|OTHER||||||||||||||||||"The primary dose escalation analysis was to find the MTD, which was defined as the dose of PF-02341066 in combination with PD-0325901 at which no more than one out of six patients experience a DLT (dose limiting toxicity). The DLT was based on observed toxicity in cycle 1, and was defined as an almost certainly or probably drug-related adverse event to PF-02341066 and/or PD-0325901.~The MTD for the PD 0325901/PF-02341066 combination was 8mg BD(days1-21) and 200mg BD continuously in a 28 day cycle (Dose Level 4)."|||
70859435|NCT01827358|141205437|OTHER|For strong control of the family-wise error rate at the 0.05 confidence level, the Holm procedure (Holm 1979) is used. Under this procedure, the p-values from the two tests are sorted as p\_((1)) (smaller p-value) and p\_((2)) (larger p-value). If p\_((1))=0.025 and p\_((2))=0.05, then the null hypotheses for both tests are rejected. If p\_((1))=0.025 and p\_((2))\>0.05, then only the null hypothesis associated with the smaller p-value is rejected. In any other case, neither null hypothesis is rejected|Odds Ratio (OR)|315.2|||<|0.001|TWO_SIDED|97.5|49.6|2698.8|||Fisher Exact|||||2698.8|49.6|<0.001
70859436|NCT01827358|141205438|OTHER|For strong control of the family-wise error rate at the 0.05 confidence level, the Holm procedure (Holm 1979) is used. Under this procedure, the p-values from the two tests are sorted as p\_((1)) (smaller p-value) and p\_((2)) (larger p-value). If p\_((1))=0.025 and p\_((2))=0.05, then the null hypotheses for both tests are rejected. If p\_((1))=0.025 and p\_((2))\>0.05, then only the null hypothesis associated with the smaller p-value is rejected. In any other case, neither null hypothesis is rejected|Odds Ratio (OR)|39.5|||<|0.001|TWO_SIDED|95.0|5.5|1666.3|||Fisher Exact|||||1666.3|5.5|<0.001
70946983|NCT01130168|141394124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3||||0.001|TWO_SIDED|95.0|-17.4|-6.3|||ANOVA|||||-6.3|-17.4|0.001
70859437|NCT01827358|141205439|OTHER||Hazard Ratio (HR)|1.0||||0.997|TWO_SIDED|95.0|0.3|3.28|||Cox proportional hazards model|||The association between mupirocin treatment and non-clinical SA Infection on or before Day 85 was assessed via a Cox Proportional Hazards Model. Onset time was defined as the first day of non-SA infection. Infants were right-censored at the time of discharge from the hospital or at Day 85, whichever came first.||3.28|0.30|0.997
70859438|NCT01827358|141205440|OTHER||Hazard Ratio (HR)|1.33||||0.656|TWO_SIDED|95.0|0.37|4.76|||Cox proportional hazards model|||The association between mupirocin treatment and non-clinical SA Infection on or before Day 85 was assessed via a Cox Proportional Hazards Model. Onset time was defined as the first day of non-SA infection. Infants were right-censored at the time of discharge from the hospital or at Day 85, whichever came first.||4.76|0.37|0.656
70946984|NCT01130168|141394125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8||||0.186|TWO_SIDED|95.0|-9.5|1.8|||ANOVA|||||1.8|-9.5|0.186
70859439|NCT01827358|141205442|OTHER||Hazard Ratio (HR)|0.23||||0.182|TWO_SIDED|95.0|0.03|2.01|||Cox proportional hazards models|||The time to clinical infection with SA on or prior to Day 22 was analyzed using Kaplan-Meier estimates of the survival curve and Cox proportional hazards models (with treatment as the only independent variable). Infants were censored at Day 22 or completion or early termination from the study. Estimates of the hazard ratio (values less than one indicating a treatment benefit) with Wald 95% confidence intervals and accompanying p-values were calculated.||2.01|0.03|0.182
70859440|NCT01827358|141205443|OTHER||Hazard Ratio (HR)|0.24||||0.198|TWO_SIDED|95.0|0.03|2.12|||Cox proportional hazards model|||The time to clinical infection with SA on or prior to Day 22 was analyzed using Kaplan-Meier estimates of the survival curve and Cox proportional hazards models (with treatment as the only independent variable). Infants were censored at Day 22 or completion or early termination from the study. Estimates of the hazard ratio (values less than one indicating a treatment benefit) with Wald 95% confidence intervals and accompanying p-values were calculated.||2.12|0.03|0.198
70946985|NCT01130168|141394125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.1|||<|0.0005|TWO_SIDED|95.0|-21.7|-10.5|||ANOVA|||||-10.5|-21.7|<0.0005
70859441|NCT00510952|141205448|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin was 0.4%.|Mean Difference (Net)|-0.05||||0.551||95.0|-0.21|0.11||P-value for Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).|Hypothesis: Basal analog insulin lispro protamine suspension, injected once or twice daily is noninferior to basal analog insulin glargine, injected once a day, with regard to glycemic control as measured by change in HbA1c from baseline to 24 week endpoint (last observation carried forward).||0.11|-0.21|0.551
70859442|NCT00510952|141205449|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.427||95.0|-0.21|0.09||P-value for Week 12 HbA1c.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).|||0.09|-0.21|0.427
70946986|NCT01130168|141394126|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-9.2|||<|0.0005|TWO_SIDED|95.0|-12.1|-6.4|||ANOVA|||||-6.4|-12.1|<0.0005
70946987|NCT01130168|141394126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.035|TWO_SIDED|95.0|-6.0|-0.3|||ANOVA|||||-0.3|-6.0|0.035
70946988|NCT01130168|141394127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.428|TWO_SIDED|95.0|-6.1|2.6|||ANOVA|||||2.6|-6.1|0.428
70946989|NCT01130168|141394127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.8|||<|0.0005|TWO_SIDED|95.0|-13.1|-4.5|||ANOVA|||||-4.5|-13.1|<0.0005
70946990|NCT01130168|141394128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||<|0.0005|TWO_SIDED|95.0|-17.5|-10.0|||ANOVA|||||-10.0|-17.5|<0.0005
70946991|NCT01130168|141394128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8||||0.015|TWO_SIDED|95.0|-8.5|-1.0|||ANOVA|||||-1.0|-8.5|0.015
70946992|NCT01130168|141394129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.112|TWO_SIDED|95.0|-9.9|1.0|||ANOVA|||||1.0|-9.9|0.112
70946993|NCT01130168|141394129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3|||<|0.0005|TWO_SIDED|95.0|-20.7|-9.8|||ANOVA|||||-9.8|-20.7|<0.0005
70859443|NCT00510952|141205449|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.427||95.0|-0.21|0.09||P-value for Week 12 Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).|||0.09|-0.21|0.427
70946994|NCT01130168|141394130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|||<|0.0005|TWO_SIDED|95.0|-11.8|-6.2|||ANOVA|||||-6.2|-11.8|<0.0005
70946995|NCT01130168|141394130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.039|TWO_SIDED|95.0|-5.8|-0.2|||ANOVA|||||-0.2|-5.8|0.039
70946996|NCT01130168|141394131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.267|TWO_SIDED|95.0|-6.6|1.8|||ANOVA|||||1.8|-6.6|0.267
70946997|NCT01130168|141394131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.5|||<|0.0005|TWO_SIDED|95.0|-12.7|-4.3|||ANOVA|||||-4.3|-12.7|<0.0005
70859444|NCT00510952|141205449|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.254||95.0|-0.25|0.07||P-value for Week 24 HbA1c.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).|||0.07|-0.25|0.254
71130491|NCT02510001|141764772|OTHER|||||||||||||||||The primary dose escalation analysis was to find the MTD, which was defined as the dose of PF-02341066 in combination with Binimetinib at which no more than one out of six patients experience a DLT (dose limiting toxicity). The DLT was based on observed toxicity in cycle 1, and was defined as an almost certainly or probably drug-related adverse event to PF-02341066 and/or Binimetinib.|"Binimetinib 30mg BD on days 1 - 21 every 28 days with Crizotinib 250 mg OD continuously is the MTD, the recommended dose and schedule for further evaluation in our and other trials.~This was as only one DLT was experienced in 6 evaluable patients at this final dose escalation level."|||
71130492|NCT00303485|141764802|SUPERIORITY_OR_OTHER||Difference in median|-64.2|||<|0.0001|TWO_SIDED|95.0|-80.28|-46.21|||Wilcoxon rank sum test|||||-46.21|-80.28|< 0.0001
70859445|NCT00510952|141205449|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.254||95.0|-0.25|0.07||P-value for Week 24 Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).|||0.07|-0.25|0.254
70859446|NCT00510952|141205450|SUPERIORITY_OR_OTHER|||||||0.634||95.0||||P-value for HbA1c \<7.0%.|Fisher Exact|||||||0.634
70859447|NCT00510952|141205450|SUPERIORITY_OR_OTHER|||||||0.504||95.0||||P-value for HbA1c ≤6.5%.|Fisher Exact|||||||0.504
70859448|NCT00510952|141205451|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin of 0.8 millimoles per liter (mmol/L).|Mean Difference (Net)|0.06||||0.323||95.0|-0.06|0.19|||ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatment groups (Insulin Lispro Protamine Suspension minus Glargine).|Hypothesis: Insulin lispro protamine suspension is noninferior to glargine at actual morning pre-meal at endpoint.||0.19|-0.06|0.323
70859449|NCT00510952|141205452|SUPERIORITY_OR_OTHER|||||||0.302||95.0||||P-value for Actual Morning Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.302
70859450|NCT00510952|141205452|SUPERIORITY_OR_OTHER|||||||0.144||95.0||||P-value for Actual Morning Postprandial Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.144
70859451|NCT00510952|141205452|SUPERIORITY_OR_OTHER|||||||0.279||95.0||||P-value for Actual Midday Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.279
70859452|NCT00510952|141205452|SUPERIORITY_OR_OTHER|||||||0.928||95.0||||P-value for Actual Midday Postprandial Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.928
70859453|NCT00510952|141205452|SUPERIORITY_OR_OTHER|||||||0.918||95.0||||P-value for Actual Evening Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.918
70946998|NCT01702519|141394132|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence was established if 90% confidence interval (CI) of the ratio (Test/Ref) of geometric means was included in the limit of 0.80 - 1.25|Treatment Ratio|0.946|||||TWO_SIDED|90.0|0.912|0.982|||Treatment Ratio||The ratio between the geometric means of the test and reference formulations was calculated|Null hypothesis considered no difference between the two treatments.||0.982|0.912|
70859454|NCT00510952|141205452|SUPERIORITY_OR_OTHER|||||||0.875||95.0||||P-value for Actual Evening Postprandial Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.875
70859455|NCT00510952|141205452|SUPERIORITY_OR_OTHER|||||||0.316||95.0||||P-value for Actual 0300 Hours.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.316
71130493|NCT04120402|141764832|SUPERIORITY|||||||0.004|||||||ANCOVA|||||||0.004
71130494|NCT04120402|141764833|SUPERIORITY|||||||0.014|||||||ANCOVA|||||||0.014
71130495|NCT04120402|141764834|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
71130496|NCT04120402|141764835|SUPERIORITY|||||||0.518|||||||ANCOVA|||||||0.518
71130497|NCT04120402|141764836|SUPERIORITY|||||||0.028|||||||Fisher Exact|||||||0.028
70946999|NCT01702519|141394133|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if 90% confidence interval (CI) of the ratio (Test/Ref) of geometric means was included in the limit of 0.80 - 1.25.|Treatment Ratio|0.962|||||TWO_SIDED|90.0|0.92|1.0|||Treatment Ratio||The ratio between the geometric means of the test and reference formulations was calculated|Null hypothesis considered no difference between the treatments.||1.00|0.92|
70859456|NCT00510952|141205452|SUPERIORITY_OR_OTHER|||||||0.389||95.0||||P-value for Daily Mean 7-Point SMBG.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.389
70947000|NCT01795859|141394138|SUPERIORITY_OR_OTHER||LSMean Difference|-2.49|||<|0.0001|TWO_SIDED|95.0|-3.69|-1.29|||ANCOVA|||||-1.29|-3.69|<0.0001
70859457|NCT00510952|141205452|SUPERIORITY_OR_OTHER|||||||0.836||95.0||||P-value for Daily Mean Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.836
70859458|NCT00510952|141205452|SUPERIORITY_OR_OTHER|||||||0.394||95.0||||P-value for Daily Mean Postprandial Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.394
70947001|NCT01795859|141394139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.1||||0.002|TWO_SIDED|95.0|12.4|49.8|||Difference of proportions|||||49.8|12.4|0.0020
70859459|NCT00510952|141205452|SUPERIORITY_OR_OTHER|||||||0.609||95.0||||P-value for Daily Mean Morning+Evening Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.609
70859460|NCT00510952|141205453|SUPERIORITY_OR_OTHER|||||||0.468||95.0||||P-value for All Hypoglycemic Episodes.|Fisher Exact|||||||0.468
70859461|NCT00510952|141205453|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for Nocturnal Hypoglycemic Episodes.|Fisher Exact|||||||0.011
70859462|NCT00510952|141205453|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||P-value for Severe Hypoglycemic Episodes.|Fisher Exact|||||||0.036
70947002|NCT01795859|141394140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.9||||0.0022|TWO_SIDED|95.0|11.4|46.4|||Difference of proportions|||||46.4|11.4|0.0022
70947003|NCT01795859|141394141|SUPERIORITY_OR_OTHER||LSMean Difference|4.34||||0.0308|TWO_SIDED|95.0|0.41|8.27|||Mixed Models Analysis|||||8.27|0.41|0.0308
70947004|NCT01795859|141394142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.1415|TWO_SIDED|95.0|-0.3|2.3|||Mixed Models Analysis|||||2.3|-0.3|0.1415
70859463|NCT00510952|141205454|SUPERIORITY_OR_OTHER|||||||0.316||95.0||||P-value for Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group. Hypoglycemic Rate (1 year) was used.||||||0.316
70859464|NCT00510952|141205454|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Nocturnal Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group. Hypoglycemic Rate (1 year) was used.||||||<0.001
70859465|NCT00510952|141205454|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||P-value for Severe Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group. Hypoglycemic Rate (1 year) was used.||||||0.102
70859466|NCT00510952|141205456|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin of 1.5 kilograms (kg).|Mean Difference (Net)|-0.01||||0.975||95.0|-0.61|0.59||P-value for Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).|Hypothesis: insulin lispro protamine suspension is noninferior to glargine with regard to change in absolute body weight from baseline to endpoint.||0.59|-0.61|0.975
70859467|NCT00510952|141205457|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||ANCOVA|ANCOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group + Change in HbA1c from Baseline.||||||0.031
70859468|NCT00510952|141205458|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||ANCOVA|ANCOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group + Change in HbA1c from Baseline.||||||0.015
71130498|NCT01363908|141764855|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0781|TWO_SIDED|||||The P-value was from the analysis of Wilcoxon signed rank test at post-treatment time point vs baseline.|Wilcoxon signed rank test|||Analysis of 6 to \<12 year olds at 24 weeks||||0.0781
70859469|NCT00396032|141205504|SUPERIORITY_OR_OTHER|||||||0.0044||95.0||||Stratified by baseline BFR: 0-199 mL/min, 200-274 mL/min, and 275-299 mL/min.|Cochran-Mantel-Haenszel|||||||0.0044
70859470|NCT00396032|141205504|SUPERIORITY_OR_OTHER|||||||0.0035||95.0|||||Chi-squared|||||||0.0035
71130499|NCT01363908|141764855|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|TWO_SIDED|||||The P-value was from the analysis of Wilcoxon signed rank test at post-treatment time point vs baseline.|Wilcoxon signed rank test|||Analysis of 6 to \<12 year olds at 48 weeks||||0.5000
71130500|NCT01363908|141764855|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2609|TWO_SIDED|||||The P-value was from the analysis of Wilcoxon signed rank test at post-treatment time point vs baseline.|Wilcoxon signed rank test|||Analysis of 12 to \<18 year olds at 24 weeks||||0.2609
71130501|NCT01363908|141764855|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9219|TWO_SIDED|||||The P-value was from the analysis of Wilcoxon signed rank test at post-treatment time point vs baseline.|Wilcoxon signed rank test|||Analysis of 12 to \<18 year olds at 48 weeks||||0.9219
71130502|NCT01363908|141764857|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6875|TWO_SIDED|||||The P-value was from analysis of Wilcoxon signed-rank test at post-treatment time point vs. baseline.|Wilcoxon signed-rank test|||Analysis of 6 to \<12 year olds at 24 weeks||||0.6875
71130503|NCT01363908|141764857|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED|||||The P-value was from analysis of Wilcoxon signed-rank test at post-treatment time point vs. baseline.|Wilcoxon signed-rank test|||Analysis of 6 to \<12 year olds at 48 weeks||||1.0000
71130504|NCT01363908|141764857|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8181|TWO_SIDED|||||The P-value was from analysis of Wilcoxon signed-rank test at post-treatment time point vs. baseline.|Wilcoxon signed-rank test|||Analysis of 12 to \<18 year olds at 24 weeks||||0.8181
71130505|NCT01363908|141764857|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5566|TWO_SIDED|||||P-value was from analysis of Wilcoxon signed-rank test at post-treatment time point vs. baseline.|Wilcoxon signed-rank|||Analysis of 12 to \<18 year olds at 48 weeks||||0.5566
71130506|NCT01363908|141764859|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0475|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 6 to \<12 year olds at 24 weeks||||0.0475
71130507|NCT01363908|141764859|SUPERIORITY_OR_OTHER_LEGACY|||||||0.441|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.||Analysis of 6 to \<12 year olds at 48 weeks||||0.4410
71130508|NCT01363908|141764859|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0417|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 12 to \<18 year olds at 24 weeks||||0.0417
71130509|NCT01363908|141764859|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0409|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 12 to \<18 year olds at 48 weeks||||0.0409
71130510|NCT01363908|141764860|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9901|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 6 to \<12 year olds at 24 weeks||||0.9901
71130511|NCT01363908|141764860|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3039|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 6 to \<12 year olds at 48 weeks||||0.3039
71130512|NCT01363908|141764860|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0044|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 12 to \<18 year olds at 24 weeks||||0.0044
71130513|NCT01363908|141764860|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0395|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 12 to \<18 year olds at 48 weeks||||0.0395
71130514|NCT03078855|141764906|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.26|TWO_SIDED|95.0|0.83|1.98|||Regression, Cox||The EFS hazard ratio was adjusted for enrolling site, continuous age at randomization, and (via stratification) 3 randomization strata: non-follicular histology, follicular (FL) with low/intermediate FLIPI score and FL with high FLIPI score.|||1.98|0.83|0.26
71130515|NCT04124705|141764934|NON_INFERIORITY|If the lower limit of the 2-sided 95% confidence interval for stratified response rate difference was greater than the non-inferiority margin, the null hypothesis would be rejected and the noninferiority of Armour Thyroid to levothyroxine would be declared.|Stratified Response Rate Difference|-15.16|||||TWO_SIDED|95.0|-26.1|-4.23|||||The response rate difference (Armour Thyroid group minus Levothyroxine group) and the 95% confidence interval were calculated using the Mantel-Haenszel-weighted method with the age group (age \< 65 years or ≥ 65 years) as a stratification factor.|The null hypothesis was that Armour Thyroid would be inferior to levothyroxine for the primary efficacy endpoint, sustained TSH response. The non-inferiority hypothesis test was performed at a 1-sided 2.5% level of significance (equivalent to a two-sided 5% level of significance).||-4.23|-26.10|
71130516|NCT04124705|141764935|NON_INFERIORITY|If the lower limit of the 2-sided 95% confidence interval for stratified response rate difference was greater than the non-inferiority margin, the null hypothesis would be rejected and the noninferiority of Armour Thyroid to levothyroxine would be declared.|Stratified Response Rate Difference|-10.52|||||TWO_SIDED|95.0|-18.65|-2.38|||||The response rate difference (Armour Thyroid group minus Levothyroxine group) and the 95% confidence interval were calculated using the Mantel-Haenszel-weighted method with the age group (age \< 65 years or ≥ 65 years) as a stratification factor.|The null hypothesis was that Armour Thyroid would be inferior to levothyroxine for titration TSH response. The non-inferiority hypothesis test was performed at a 1-sided 2.5% level of significance.||-2.38|-18.65|
71130517|NCT01973998|141764936|EQUIVALENCE|The primary outcome is time from randomization to a composite outcome of all cause re-hospitalization and all-cause mortality, whichever comes first. The primary analysis will be a log-ranked test and associated Kaplan-Meier plot, unadjusted for any covariates|Hazard Ratio (HR)|1.654|STANDARD_DEVIATION|0.4789|<|0.1|TWO_SIDED|10.0|1.175|2.133||Because this is a pilot study the intent is to see if there is a signal that would justify a larger clinical trial. Therefore the significance level has been set to 0.1 and the power has been set at 0.7.|Log Rank|||||2.133|1.175|<0.1
70947005|NCT03738397|141394143|SUPERIORITY||Adjusted Response Rate Difference|9.7||||0.007|TWO_SIDED|95.0|2.6|16.7||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for vIGA-AD categories (moderate \[3\] versus severe \[4\]).|Response rate difference = Upadacitinib - Dupilumab|||16.7|2.6|0.007
70947006|NCT03738397|141394144|SUPERIORITY||Least Squares (LS) Mean Difference|-18.21|STANDARD_ERROR_OF_MEAN|2.753|<|0.001|TWO_SIDED|95.0|-23.61|-12.8||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD categories in the model.|Difference = Upadacitinib - Dupilumab|||-12.80|-23.61|<0.001
70947007|NCT03738397|141394145|SUPERIORITY||Adjusted Response Rate Difference|20.4|||<|0.001|TWO_SIDED|95.0|14.8|26.0||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for vIGA-AD categories (moderate \[3\] versus severe \[4\]).|Response rate difference = Upadacitinib - Dupilumab|||26.0|14.8|<0.001
70947008|NCT03738397|141394146|SUPERIORITY||Adjusted Response Rate Difference|21.2|||<|0.001|TWO_SIDED|95.0|13.8|28.6||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for vIGA-AD categories (moderate \[3\] versus severe \[4\]).|Response rate difference = Upadacitinib - Dupilumab|||28.6|13.8|<0.001
70947009|NCT03738397|141394147|SUPERIORITY||LS Mean Difference|-28.02|STANDARD_ERROR_OF_MEAN|3.177|<|0.001|TWO_SIDED|95.0|-34.25|-21.78||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD categories in the model.|Difference = Upadacitinib - Dupilumab|||-21.78|-34.25|<0.001
70859471|NCT00396032|141205506|SUPERIORITY_OR_OTHER|||||||0.0396||95.0||||Stratified by baseline BFR: 0-199 mL/min, 200-274 mL/min, and 275-299 mL/min.|Cochran-Mantel-Haenszel|||||||0.0396
70859472|NCT03070444|141205509|OTHER|GEE analysis|GEE analysis|0.99||||0.0002|TWO_SIDED|95.0|0.48|1.51|||GEE analysis|||||1.51|0.48|0.0002
70859473|NCT03070444|141205510|OTHER|Mann-Whitney U test||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
70859474|NCT01373489|141205511|SUPERIORITY||Mean Difference (Final Values)|10.0|||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
70859475|NCT02582255|141205520|OTHER|||||||0.05|||||||Clopper-Pearson|||||||0.05
70859476|NCT02582255|141205521|OTHER|||||||0.025|||||||Clopper-Pearson|||||||0.025
70859477|NCT02582255|141205522|OTHER|||||||0.025|||||||Clopper-Pearson|||||||0.025
70859478|NCT02582255|141205523|OTHER|||||||0.05|||||||Clopper-Pearson|||||||0.05
70859479|NCT04854642|141205524|OTHER||Least square mean difference|71.62|||<|0.0001|TWO_SIDED|90.0|68.13|75.29|||ANOVA|||||75.29|68.13|<0.0001
70859480|NCT04854642|141205525|OTHER||Least square mean difference|90.93||||0.017|TWO_SIDED|90.0|85.3|96.93|||ANOVA|||||96.93|85.30|0.0170
70859481|NCT04854642|141205526|OTHER||Least square mean difference|90.9||||0.0213|TWO_SIDED|90.0|85.04|97.16|||ANOVA|||||97.16|85.04|0.0213
70859482|NCT04854642|141205527|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
70859483|NCT02417844|141205563|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence range of 80% to 125%.|Geometric mean ratio (%)|99.66|STANDARD_DEVIATION|19.15|||TWO_SIDED|90.0|92.19|107.74|||||"The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation.~Ratio calculated as test divided by reference."|||107.74|92.19|
70859484|NCT02417844|141205564|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence range of 80% to 125%.|Geometric mean ratio (%)|99.58|STANDARD_DEVIATION|13.51|||TWO_SIDED|90.0|94.23|105.24|||||"The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation.~Ratio calculated as test divided by reference."|||105.24|94.23|
70859485|NCT02417844|141205565|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence range of 80% to 125%.|Geometric mean ratio (%)|99.48|STANDARD_DEVIATION|14.12|||TWO_SIDED|90.0|93.9|105.39|||||"The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation.~Ratio calculated as test divided by reference."|||105.39|93.90|
70859486|NCT00076024|141205569|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.237||||0.156|TWO_SIDED|95.0|0.819|1.867|||Log Rank|One-sided log-rank test at alpha = 0.1 significance level was used.||P-value was calculated using one-sided Log rank test, stratified for estrogen receptor (ER) status (ER-positive or ER-negative/unknown), prior adjuvant chemotherapy (yes or no), and Eastern Cooperative Oncology Group (ECOG) performance status (less than or equal to \[=\<1\] or 2). The stratified Cox proportional hazards model was fitted, using the same stratification variables as above.||1.867|0.819|0.156
70859487|NCT00076024|141205570|SUPERIORITY_OR_OTHER||Difference in response rates|17.4||||0.038|TWO_SIDED|95.0|3.0|31.9|||Fisher Exact|||||31.9|3.0|0.038
70859488|NCT00988325|141205586|SUPERIORITY_OR_OTHER||Median time to cessation of viral sheddi|119.0|||=|0.166|TWO_SIDED|95.0|113.0|230.0||p-value is for the comparison of the age cohorts (treatment groups)|Wilcoxon (Mann-Whitney)|Wilcoxon Test was used for testing homogeneity of survival curves|Median time was estimated from the Kaplan-Meier curve (unstratified)|||230|113|=0.166
70859489|NCT00988325|141205588|SUPERIORITY_OR_OTHER||Time to Resolution of Fever in Patients|14.5|||=|0.059|TWO_SIDED|95.0|12.0|20.0||The p-value is for the comparison of the age cohorts (not including Total)|Wilcoxon (Mann-Whitney)||Median time was estimated from the Kaplan-Meier curve (unstratified)|||20|12|=0.059
70859490|NCT01155219|141205592|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
70859491|NCT00403403|141205603|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.528||||0.0097||95.0|0.323|0.862|||Log Rank||HR estimated from a stratified Cox regression model, stratified for ECOG performance (0-1 vs. 2) and chemotherapy type (cisplatin vs. carboplatin)|||0.862|0.323|0.0097
70859492|NCT00403403|141205604|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.6054|TWO_SIDED|95.0|0.66|2.039|||Log Rank||HR estimated from a stratified Cox regression model, stratified for ECOG performance (0-1 vs. 2) and chemotherapy type (cisplatin vs. carboplatin)|||2.039|0.660|0.6054
70859493|NCT00403403|141205605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7||||0.3269||95.0|-9.6|29.0|||Chi-squared|||||29.0|-9.6|0.3269
70859494|NCT00403403|141205607|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.305||||0.0011|TWO_SIDED|95.0|0.144|0.644|||Log Rank||HR estimated from a stratified Cox regression model, stratified for ECOG performance (0-1 vs. 2) and chemotherapy type (cisplatin vs. carboplatin)|||0.644|0.144|0.0011
70859495|NCT00472459|141205618|NON_INFERIORITY|Participant's number of new skin lesions between treated and contralateral control area were evaluated using a paired t-test for lesions of any type as well as stratified by lesion type.|Mean Difference (Final Values)|0.514||||0.012|TWO_SIDED|95.0|0.116|0.911|||t-test, 2 sided||The 95 % confidence intervals for the lesion complete response rates and lesion recurrence rates were estimated using the method of Clopper and Pearson.|||0.911|0.116|0.0120
70859496|NCT00472459|141205619|NON_INFERIORITY|Participant's number of new skin lesions between treated and contralateral control area were evaluated using a paired t-test for lesions of any type as well as stratified by lesion type.|Mean Difference (Final Values)|0.413||||0.1761|TWO_SIDED|95.0|-0.19|1.016|||t-test, 2 sided|||||1.016|-0.190|0.1761
70859497|NCT00472459|141205620|NON_INFERIORITY|Participant's number of new skin lesions between treated and contralateral control area were evaluated using a paired t-test for lesions of any type as well as stratified by lesion type.|Mean Difference (Final Values)|0.6||||0.1183|TWO_SIDED|95.0|-0.156|1.357|||t-test, 2 sided|||||1.357|-0.156|0.1183
70859498|NCT00472459|141205621|NON_INFERIORITY|Participant's number of new skin lesions between treated and contralateral control area were evaluated using a paired t-test for lesions of any type as well as stratified by lesion type.|Mean Difference (Final Values)|0.493||||0.2322|TWO_SIDED|95.0|-0.323|1.309|||t-test, 2 sided|||||1.309|-0.323|0.2322
70859499|NCT00472459|141205622|NON_INFERIORITY|Participant's number of new skin lesions between treated and contralateral control area were evaluated using a paired t-test for lesions of any type as well as stratified by lesion type.|Mean Difference (Final Values)|0.68||||0.1286|TWO_SIDED|95.0|-0.202|1.562|||t-test, 2 sided|||||1.562|-0.202|0.1286
70859500|NCT03981822|141205646|SUPERIORITY|||||||0.0048||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Part B summary is pooled with its respective treatments from Part A.||||0.0048
70859501|NCT03981822|141205646|SUPERIORITY|||||||0.0075||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Part B summary is pooled with its respective treatments from Part A.||||0.0075
70859502|NCT03981822|141205647|SUPERIORITY|||||||0.3642||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 2 - Part B summary is pooled with its respective treatments from Part A.||||0.3642
70859503|NCT03981822|141205647|SUPERIORITY|||||||0.0967||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||||0.0967
70859504|NCT03981822|141205647|SUPERIORITY|||||||0.0648||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||||0.0648
70859505|NCT03981822|141205647|SUPERIORITY|||||||0.1357||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||||0.1357
70859506|NCT03981822|141205647|SUPERIORITY|||||||0.019||||||P-value is based on the CMH test stratified by gender. Part B summary is pooled with its respective treatments from|Cochran-Mantel-Haenszel|||Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.||||0.0190
70859507|NCT03981822|141205647|SUPERIORITY|||||||0.0184||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.||||0.0184
70859508|NCT03981822|141205647|SUPERIORITY|||||||0.0048||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Study Day 84 EOT Visit - Part B summary is pooled with its respective treatments from Part A.||||0.0048
70859509|NCT03981822|141205647|SUPERIORITY|||||||0.0075||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Study Day 84 EOT Visit - Part B summary is pooled with its respective treatments from Part A.||||0.0075
70859510|NCT03981822|141205647|SUPERIORITY|||||||0.0539||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 112 - Part B summary is pooled with its respective treatments from Part A.||||0.0539
70859511|NCT03981822|141205647|SUPERIORITY|||||||0.1638||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 112 - Part B summary is pooled with its respective treatments from Part A.||||0.1638
70859512|NCT03981822|141205647|SUPERIORITY|||||||0.4766||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 147 EOS - Part B summary is pooled with its respective treatments from Part A.||||0.4766
70859513|NCT03981822|141205647|SUPERIORITY|||||||0.1588||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 147 EOS - Part B summary is pooled with its respective treatments from Part A.||||0.1588
70859514|NCT03981822|141205648|SUPERIORITY|||||||0.3642||||||P-value is based on the CMH test stratified by gender. Part B summary is pooled with its respective treatments from Part A.|Cochran-Mantel-Haenszel|||Treatment Visit 2 Part B summary is pooled with its respective treatments from Part A.||||0.3642
70859515|NCT03981822|141205648|SUPERIORITY|||||||0.0356|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 3 Part B summary is pooled with its respective treatments from Part A.||||0.0356
70859516|NCT03981822|141205648|SUPERIORITY|||||||0.0118|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender||Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.||||0.0118
70859517|NCT03981822|141205648|SUPERIORITY|||||||0.0026||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Study Day84 EOT Part B summary is pooled with its respective treatments from Part A.||||0.0026
70859518|NCT03981822|141205648|SUPERIORITY|||||||0.0174|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up Visit Day 112 Part B summary is pooled with its respective treatments from Part A.||||0.0174
70859519|NCT03981822|141205648|SUPERIORITY|||||||0.1311|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up Visit Day 147 EOS Part B summary is pooled with its respective treatments from Part A.||||0.1311
70859520|NCT03981822|141205648|SUPERIORITY|||||||0.0967|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 2 Part B summary is pooled with its respective treatments from Part A.||||0.0967
70859521|NCT03981822|141205648|SUPERIORITY|||||||0.1357|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 3 Part B summary is pooled with its respective treatments from Part A.||||0.1357
70859522|NCT03981822|141205648|SUPERIORITY|||||||0.0184|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.||||0.0184
70859523|NCT03981822|141205648|SUPERIORITY|||||||0.0024|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Study Day 84 EOT Visit Part B summary is pooled with its respective treatments from Part A.||||0.0024
70859524|NCT03981822|141205648|SUPERIORITY|||||||0.1034|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up Visit Day 112 Part B summary is pooled with its respective treatments from Part A.||||0.1034
70859525|NCT03981822|141205648|SUPERIORITY|||||||0.1029|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up Visit Day 147 EOS Part B summary is pooled with its respective treatments from Part A.||||0.1029
70859526|NCT03981822|141205649|SUPERIORITY|||||||0.0356|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||||0.0356
70859527|NCT03981822|141205649|SUPERIORITY|||||||0.1477|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||||0.1477
70859528|NCT03981822|141205649|SUPERIORITY|||||||0.0062|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||||0.0062
70859529|NCT03981822|141205649|SUPERIORITY|||||||0.0046|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||||0.0046
70859530|NCT03981822|141205649|SUPERIORITY|||||||0.0177|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||||0.0177
70859531|NCT03981822|141205649|SUPERIORITY|||||||0.0054|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||||0.0054
70859532|NCT03981822|141205649|SUPERIORITY|||||||0.0013|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Study Day 84 (EOT) visit: Part B summary is pooled with its respective treatments from Part A.||||0.0013
70859533|NCT03981822|141205649|SUPERIORITY|||||||0.0034|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Study Day 84 (EOT) Visit: Part B summary is pooled with its respective treatments from Part A.||||0.0034
70859534|NCT03981822|141205649|SUPERIORITY|||||||0.0156|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up visit day 112: Part B summary is pooled with its respective treatments from Part A.||||0.0156
70859535|NCT03981822|141205649|SUPERIORITY|||||||0.0367|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up visit day 112: Part B summary is pooled with its respective treatments from Part A.||||0.0367
70859536|NCT03981822|141205649|SUPERIORITY|||||||0.1746|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up visit day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.||||0.1746
70859537|NCT03981822|141205649|SUPERIORITY|||||||0.0123|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up visit day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.||||0.0123
70859538|NCT03981822|141205650|SUPERIORITY||LS mean difference|-3.96||||0.0021|TWO_SIDED|95.0|-5.41|-1.24||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, Tx by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||-1.24|-5.41|0.0021
70859539|NCT03981822|141205650|SUPERIORITY||LS mean difference|-4.72||||0.015|TWO_SIDED|95.0|-5.95|-0.66|||Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||-0.66|-5.95|0.0150
70859540|NCT03981822|141205650|SUPERIORITY||LS mean difference|-5.31||||0.0011|TWO_SIDED|95.0|-6.54|-1.69||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||-1.69|-6.54|0.0011
70859541|NCT03981822|141205650|SUPERIORITY||LS mean difference|-6.5||||0.0007|TWO_SIDED|95.0|-8.25|-2.32||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Study Day 84 EOT Visit: Part B summary is pooled with its respective treatments from Part A.||-2.32|-8.25|0.0007
70859542|NCT03981822|141205650|SUPERIORITY||LS mean difference|-6.15||||0.0012|TWO_SIDED|95.0|-7.5|-1.91||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow-up day 112: Part B summary is pooled with its respective treatments from Part A.||-1.91|-7.50|0.0012
70859543|NCT03981822|141205650|SUPERIORITY||LS mean difference|-5.02||||0.0349|TWO_SIDED|95.0|-6.78|-0.26||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow-up visit day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.||-0.26|-6.78|0.0349
70859544|NCT03981822|141205650|SUPERIORITY||LS mean difference|-4.76|||<|0.0001|TWO_SIDED|95.0|-7.47|-2.85||P-value is based on MMRM mode|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment visit 2: Part B summary is pooled with its respective treatments from Part A.||-2.85|-7.47|<0.0001
70859545|NCT03981822|141205650|SUPERIORITY||LS mean difference|-6.0||||0.0005|TWO_SIDED|95.0|-8.37|-2.43||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 3: Degrees of freedom associated with the error term were computed using Kenward-Rogers method.||-2.43|-8.37|0.0005
70859546|NCT03981822|141205650|SUPERIORITY||LS mean difference|-6.64|||<|0.0001|TWO_SIDED|95.0|-9.65|-4.12||Analysis based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment visit 4: Part B summary is pooled with its respective treatments from Part A.||-4.12|-9.65|<0.0001
70859547|NCT03981822|141205650|SUPERIORITY||LS mean difference|-6.49||||0.0004|TWO_SIDED|95.0|-9.67|-2.92||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.||-2.92|-9.67|0.0004
70859548|NCT03981822|141205650|SUPERIORITY||LS mean difference|-6.96|||<|0.0001|TWO_SIDED|95.0|-9.89|-3.57||Analysis based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow-up day 112: Part B summary is pooled with its respective treatments from Part A.||-3.57|-9.89|<0.0001
70859549|NCT03981822|141205650|SUPERIORITY||LS mean difference|-6.99||||0.0005|TWO_SIDED|95.0|-10.2|-2.94||Analysis based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow up day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.||-2.94|-10.20|0.0005
70859550|NCT03981822|141205651|SUPERIORITY||LS mean difference|-41.47|||<|0.0001|TWO_SIDED|95.0|-51.31|-20.87||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||-20.87|-51.31|<0.0001
70859551|NCT03981822|141205651|SUPERIORITY||LS mean difference|-50.95||||0.0004|TWO_SIDED|95.0|-66.18|-19.56||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||-19.56|-66.18|0.0004
70859552|NCT03981822|141205651|SUPERIORITY||LS mean difference|-66.21|||<|0.0001|TWO_SIDED|95.0|-88.15|-35.87||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||-35.87|-88.15|<0.0001
70859553|NCT03981822|141205651|SUPERIORITY||LS mean difference|-79.37|||<|0.0001|TWO_SIDED|95.0|-111.44|-49.77||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Study Day 84 End of Treatment Visit: Part B summary is pooled with its respective treatments from Part A.||-49.77|-111.44|<0.0001
70947010|NCT03738397|141394148|SUPERIORITY||Adjusted Response Rate Difference|26.0|||<|0.001|TWO_SIDED|95.0|19.3|32.7||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for vIGA-AD categories (moderate \[3\] versus severe \[4\]).|Response rate difference = Upadacitinib - Dupilumab|||32.7|19.3|<0.001
70947011|NCT03738397|141394149|SUPERIORITY||LS Mean Difference|-23.02|STANDARD_ERROR_OF_MEAN|2.548|<|0.001|TWO_SIDED|95.0|-28.03|-18.02||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD categories in the model.|Difference = Upadacitinib - Dupilumab|||-18.02|-28.03|<0.001
70947012|NCT03738397|141394150|SUPERIORITY||Adjusted Response Rate Difference|19.8|||<|0.001|TWO_SIDED|95.0|12.4|27.3||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for vIGA-AD categories (moderate \[3\] versus severe \[4\]).|Response rate difference = Upadacitinib - Dupilumab|||27.3|12.4|<0.001
70947013|NCT03448536|141394171|SUPERIORITY||LS Means Difference|4.31|||<|0.001|TWO_SIDED|95.0|2.06|6.56|||ANCOVA|||||6.56|2.06|< 0.001
70859554|NCT03981822|141205651|SUPERIORITY||LS mean difference|-69.79||||0.0001|TWO_SIDED|95.0|-103.17|-35.25||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow up Day 112: Part B summary is pooled with its respective treatments from Part A.||-35.25|-103.17|0.0001
70859555|NCT03981822|141205651|SUPERIORITY||LS mean difference|-41.22||||0.1033|TWO_SIDED|95.0|-90.61|8.56||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.||8.56|-90.61|0.1033
70859556|NCT03981822|141205651|SUPERIORITY||LS mean difference|-58.43|||<|0.0001|TWO_SIDED|95.0|-73.26|-39.39||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||-39.39|-73.26|<0.0001
70859557|NCT03981822|141205651|SUPERIORITY||LS mean difference|-69.86|||<|0.0001|TWO_SIDED|95.0|-81.61|-28.8||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||-28.80|-81.61|<0.0001
70859558|NCT03981822|141205651|SUPERIORITY||LS mean difference|-76.55|||<|0.0001|TWO_SIDED|95.0|-107.19|-45.61||P-value is based on MMRM model with gender, treatment, visit, treatment by visit interaction, and baseline wart count as factors.|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||-45.61|-107.19|<0.0001
70859559|NCT03981822|141205651|SUPERIORITY||LS mean difference|-74.29||||0.0003|TWO_SIDED|95.0|-102.96|-31.55||P-value is based on MMRM model with gender, treatment, visit, treatment by visit interaction, and baseline wart count as factors.|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Study Day 84 End of Treatment Visit: Part B summary is pooled with its respective treatments from Part A.||-31.55|-102.96|0.0003
70859560|NCT03981822|141205651|SUPERIORITY||LS mean difference|-77.1||||0.0004|TWO_SIDED|95.0|-110.32|-32.78||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow-up Day 112: Part B summary is pooled with its respective treatments from Part A.||-32.78|-110.32|0.0004
70859561|NCT03981822|141205651|SUPERIORITY||LS mean difference|-77.52||||0.0178|TWO_SIDED|95.0|-120.82|-11.88||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow-up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.||-11.88|-120.82|0.0178
70859562|NCT03981822|141205652|SUPERIORITY|||||||0.0004||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||||0.0004
70859563|NCT03981822|141205652|SUPERIORITY|||||||0.0005||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||||0.0005
70859564|NCT03981822|141205652|SUPERIORITY|||||||0.0698||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||||0.0698
70859565|NCT03981822|141205652|SUPERIORITY|||||||0.01||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||||0.0100
70859566|NCT03981822|141205652|SUPERIORITY|||||||0.0101||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||||0.0101
70859567|NCT03981822|141205652|SUPERIORITY|||||||0.0077||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||||0.0077
70859568|NCT03981822|141205652|SUPERIORITY|||||||0.064||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Study Day 84 EOT Visit: Part B summary is pooled with its respective treatments from Part A.||||0.0640
70859569|NCT03981822|141205652|SUPERIORITY|||||||0.0045||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Study Day 84 EOT: Part B summary is pooled with its respective treatments from Part A.||||0.0045
70859570|NCT03981822|141205652|SUPERIORITY|||||||0.284||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 112: Part B summary is pooled with its respective treatments from Part A.||||0.2840
70859571|NCT03981822|141205652|SUPERIORITY|||||||0.0132||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 112: Part B summary is pooled with its respective treatments from Part A.||||0.0132
70859572|NCT03981822|141205652|SUPERIORITY|||||||0.4668||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 147 EOS: Part B summary is pooled with its respective treatments from Part A.||||0.4668
70859573|NCT03981822|141205652|SUPERIORITY|||||||0.0064||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 147 EOS: Part B summary is pooled with its respective treatments from Part A.||||0.0064
70859574|NCT03981822|141205653|SUPERIORITY|||||||0.0364|||||||Mantel Haenszel|Stratified by gender||Part B summary is pooled with its respective treatments from Part A.||||0.0364
70859575|NCT03981822|141205653|SUPERIORITY|||||||0.0215|||||||Cochran-Mantel-Haenszel|Stratified by gender||Part B summary is pooled with its respective treatments from Part A.||||0.0215
70859576|NCT03981822|141205654|SUPERIORITY||LS mean difference|-59.63||||0.1222|TWO_SIDED|95.0|-76.1|9.23||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Study Day 84 (EOT: Part B summary is pooled with its respective treatments from Part A.||9.23|-76.10|0.1222
70859577|NCT03981822|141205654|SUPERIORITY||LS mean difference|-69.51||||0.0403|TWO_SIDED|95.0|-81.3|-1.9||Analysis based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Study Day 112 (EOT: Part B summary is pooled with its respective treatments from Part A.||-1.90|-81.30|0.0403
70859578|NCT03981822|141205654|SUPERIORITY||LS mean difference|-58.88||||0.0863|TWO_SIDED|95.0|-77.79|5.33||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Visit Day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.||5.33|-77.79|0.0863
70859579|NCT03981822|141205654|SUPERIORITY||LS mean difference|-62.13||||0.0428|TWO_SIDED|95.0|-100.76|-1.73||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.||-1.73|-100.76|0.0428
70947014|NCT03448536|141394172|SUPERIORITY||LS Means Difference|9.8|||<|0.001|TWO_SIDED|95.0|5.75|13.85|||ANCOVA|||||13.85|5.75|< 0.001
70859580|NCT03981822|141205654|SUPERIORITY||LS mean difference|-71.93||||0.0084|TWO_SIDED|95.0|-110.46|-17.0||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Day 112: Part B summary is pooled with its respective treatments from Part A.||-17.00|-110.46|0.0084
70859581|NCT03981822|141205654|SUPERIORITY||LS mean difference|-63.11||||0.0273|TWO_SIDED|95.0|-103.08|-6.35||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Visit Day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.||-6.35|-103.08|0.0273
70859582|NCT03981822|141205655|SUPERIORITY|Analysis is based on MMRM model|LS mean difference|-44.65||||0.3083|TWO_SIDED|95.0|-69.96|22.47|||Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.||22.47|-69.96|0.3083
70859583|NCT03981822|141205655|SUPERIORITY||LS mean difference|-55.8||||0.1686|TWO_SIDED|95.0|-86.93|15.56||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Day 112: Part B summary is pooled with its respective treatments from Part A.||15.56|-86.93|0.1686
70859584|NCT03981822|141205655|SUPERIORITY||LS mean difference|-38.06||||0.2384|TWO_SIDED|95.0|-87.04|22.1||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.||22.10|-87.04|0.2384
70859585|NCT03981822|141205655|SUPERIORITY||LS mean difference|-61.96||||0.0603|TWO_SIDED|95.0|-103.37|2.27||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.||2.27|-103.37|0.0603
70859586|NCT03981822|141205655|SUPERIORITY||LS mean difference|-74.87||||0.0109|TWO_SIDED|95.0|-138.71|-18.83||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Visit Day 112: Part B summary is pooled with its respective treatments from Part A.||-18.83|-138.71|0.0109
70859587|NCT03981822|141205655|SUPERIORITY||LS mean difference|-66.62||||0.0467|TWO_SIDED|95.0|-127.64|-0.99||Analysis is base on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.||-0.99|-127.64|0.0467
70859588|NCT06460493|141205656|OTHER|The proportion of subjects classified as responders at week 12, standard errors, and corresponding 95% CI was estimated by negative binomial regression with background therapy (LABA/LAMA or LABA/LAMA/ICS) included as a fixed effect, and with baseline CAT score included as a covariate. The scale parameter in the negative binomial model was held fixed by specifying a noscale option.|Negative binomial regression|67.0|||||TWO_SIDED|95.0|38.0|100.0|||||A two-sided unadjusted 95% confidence interval for the proportion was used to determine study success with the lower bound of the CI \> 0 indicating success.|||100.0|38.0|
70859589|NCT06460493|141205657|OTHER|The proportion of subjects classified as responders at week 6, standard errors, and corresponding 95% CI was estimated by negative binomial regression with background therapy (LABA/LAMA or LABA/LAMA/ICS) included as a fixed effect, and with baseline CAT score included as a covariate. The scale parameter in the negative binomial model was held fixed by specifying a noscale option.|Negative binomial regression|44.4|||||TWO_SIDED|95.0|22.0|89.5|||||A two-sided unadjusted 95% confidence interval for the proportion was used to determine study success with the lower bound of the CI \> 0 indicating success.|||89.5|22.0|
70859590|NCT00054717|141205675|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
70859591|NCT00054717|141205676|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
70859592|NCT00054717|141205677|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
70859593|NCT00054717|141205678|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
70859594|NCT00054717|141205679|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
70859595|NCT00054717|141205680|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
70859596|NCT00054717|141205681|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
70859597|NCT00054717|141205682|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
70859598|NCT00054717|141205683|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
70859599|NCT00054717|141205684|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
70859600|NCT00054717|141205685|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
70859601|NCT00054717|141205686|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
70859602|NCT00054717|141205687|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
70859603|NCT00054717|141205688|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
70859604|NCT00054717|141205689|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
70859605|NCT00054717|141205690|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
70859606|NCT00054717|141205691|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
70859607|NCT00054717|141205692|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
70947015|NCT03448536|141394173|SUPERIORITY||LS Means Difference|1.52|||=|0.129|TWO_SIDED|95.0|-0.45|3.49|||ANCOVA|||||3.49|-0.45|= 0.129
70859608|NCT00054717|141205693|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
70859609|NCT00054717|141205694|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
70859610|NCT00054717|141205734|SUPERIORITY_OR_OTHER|||||||0.9894||95.0|||||Log Rank|||||||0.9894
70947016|NCT03448536|141394174|SUPERIORITY||LS Means Difference|8.27|||<|0.001|TWO_SIDED|95.0|5.76|10.78|||ANCOVA|||||10.78|5.76|< 0.001
70947017|NCT03448536|141394175|SUPERIORITY||LS Means Difference|0.56|||=|0.307|TWO_SIDED|95.0|-0.52|1.64|||ANCOVA|||||1.64|-0.52|= 0.307
70947018|NCT03448536|141394176|SUPERIORITY||LS Means Difference|3.75|||<|0.001|TWO_SIDED|95.0|2.34|5.16|||ANCOVA|||||5.16|2.34|< 0.001
70859611|NCT04251156|141205776|SUPERIORITY|Responses were analysed using an analysis of covariance model with randomized treatment and type 2 diabetes status as factors and baseline body weight as covariate.|Treatment difference|-8.47|||<|0.0001|TWO_SIDED|95.0|-10.17|-6.76|||ANCOVA|||Treatment policy estimand||-6.76|-10.17|<0.0001
70947019|NCT03448536|141394177|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||< 0.001
70947020|NCT03448536|141394179|SUPERIORITY||||||=|0.002|||||||Cochran-Mantel-Haenszel|||||||= 0.002
70859612|NCT04251156|141205777|SUPERIORITY|Responses were analysed using a binary logistic regression model with randomized treatment and type 2 diabetes status as factors and baseline body weight as covariate.|Odds Ratio (OR)|13.07|||<|0.0001|TWO_SIDED|95.0|7.4|23.1|||Regression, Logistic|||Treatment policy estimand||23.10|7.40|<0.0001
70947021|NCT03783546|141394181|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|||||||0.0003
70947022|NCT03783546|141394183|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||0.002
70947023|NCT01777126|141394213|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.0|||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The primary outcome measure was the interval from surgery to discharge. Discharge means that the patient returns to his home. Preliminary data from our institution showed that all patients received parenteral nutrition very early post-surgery and were discharged after a mean of 19.3 ± 5.6 days. Therefore, the primary objective by implementing the ONP was to reduce the length of stay with 3 days.||||<0.001
70859613|NCT04626310|141205874|SUPERIORITY||Linear slope difference DBT-ER-IP|0.096|STANDARD_ERROR_OF_MEAN|0.08||0.8|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Linear Slopes (DBT-ER vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.8
70859614|NCT04626310|141205874|SUPERIORITY||Linear Slope difference DBT-IE-IP|-0.234|STANDARD_ERROR_OF_MEAN|0.385||0.544|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Linear Slopes (DBT-IE vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.544
70859615|NCT04626310|141205874|SUPERIORITY||Linear Slope difference DBT-ER-DBT-IE|0.329|STANDARD_ERROR_OF_MEAN|0.429||0.442|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Linear Slopes (DBT-ER vs. DBT-IE) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.442
70859616|NCT04626310|141205875|SUPERIORITY||Linear slope difference DBT-ER-IP|1.951|STANDARD_ERROR_OF_MEAN|1.15||0.09|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Linear Slopes (DBT-ER vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.09
70859617|NCT04626310|141205875|SUPERIORITY||Linear slope difference DBT-IE-IP|0.1|STANDARD_ERROR_OF_MEAN|1.228||0.93|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Linear Slopes (DBT-ER vs. DBT-IE) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.93
70859618|NCT04626310|141205875|SUPERIORITY||Linear slope difference DBT-ER-DBT-IE|1.851|STANDARD_ERROR_OF_MEAN|1.103||0.93|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Linear Slopes (DBT-ER vs. DBT-IE) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.93
70859619|NCT04626310|141205875|SUPERIORITY||Quad slope difference DBT-ER-IP|-0.028|STANDARD_ERROR_OF_MEAN|0.15||0.93|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-ER vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.93
70859620|NCT04626310|141205875|SUPERIORITY||Quad slope difference DBT-IE-IP|-0.029|STANDARD_ERROR_OF_MEAN|0.145||0.836|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-IE vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.836
70859621|NCT04626310|141205875|SUPERIORITY||Quad slope difference DBT-ER-DBT-IE|0.001|STANDARD_ERROR_OF_MEAN|0.145||0.994|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-IE vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.994
71130518|NCT01973998|141764936|SUPERIORITY||Hazard Ratio (HR)|1.654|STANDARD_DEVIATION|0.4789||0.1|TWO_SIDED|10.0|1.175|2.133|||Log Rank|||A total of 100 patients is required in a 2 treatment parallel-design study. There is a 70% probability that the study will detect a treatment difference at a 2-sided 10% significance level, if the true hazard ratio is 1.654. This is based on the assumption that the accrual period will be 36 months and the follow up period will be 6 months and the median time to event is 8 months. The total number of events will be 73.||2.133|1.175|0.1
70859622|NCT04626310|141205876|SUPERIORITY||Linear slope difference DBT-ER-IP|0.059|STANDARD_ERROR_OF_MEAN|0.083||0.475|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. The slopes of the difference between neutral and negative-maintain were regressed on time (weeks, centered around the start of treatment) and calculated per condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.475
70859623|NCT04626310|141205876|SUPERIORITY||Linear slope difference DBT-IE-IP|0.037|STANDARD_ERROR_OF_MEAN|0.082||0.654|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. The slopes of the difference between neutral and negative-maintain were regressed on time (weeks, centered around the start of treatment) and calculated per condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.654
70859624|NCT04626310|141205876|SUPERIORITY||Linear slope difference DBT-ER-DBT-IE|0.022|STANDARD_ERROR_OF_MEAN|0.085||0.791|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. The slopes of the difference between neutral and negative-maintain were regressed on time (weeks, centered around the start of treatment) and calculated per condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.791
70859625|NCT04626310|141205877|SUPERIORITY||Linear slope difference DBT-ER-IP|-0.332|STANDARD_ERROR_OF_MEAN|0.095||0.001|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. We examined the effect of Negative Decrease vs. Negative Maintain over time per condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.001
70859626|NCT04626310|141205877|SUPERIORITY||Linear slope difference DBT-IE-IP|-0.165|STANDARD_ERROR_OF_MEAN|0.094||0.078|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. We examined the effect of Negative Decrease vs. Negative Maintain over time per condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.078
70859627|NCT04626310|141205877|SUPERIORITY||Linear slope difference DBT-ER-DBT-IE|-0.167|STANDARD_ERROR_OF_MEAN|0.095||0.08|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. We examined the effect of Negative Decrease vs. Negative Maintain over time per condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.080
70859628|NCT04626310|141205878|SUPERIORITY||Linear Slope Diff DBT-ER-IP|0.091|STANDARD_ERROR_OF_MEAN|0.06||0.13|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. The Negative x Novel x time (weeks, centered around the start of treatment) slopes were calculated per condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.13
70859629|NCT04626310|141205878|SUPERIORITY||Linear slope difference DBT-IE-IP|0.12|STANDARD_ERROR_OF_MEAN|0.06||0.046|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. The Negative x Novel x time (weeks, centered around the start of treatment) slopes were calculated per condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.046
70859630|NCT04626310|141205878|SUPERIORITY||Linear slope difference DBT-ER-DBT-IE|-0.028|STANDARD_ERROR_OF_MEAN|0.057||0.617|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. The Negative x Novel x time (weeks, centered around the start of treatment) slopes were calculated per condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.617
70859631|NCT04626310|141205879|SUPERIORITY||Linear slope difference DBT-ER-IP|-0.29|STANDARD_ERROR_OF_MEAN|0.103||0.005|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of change in this interaction effect were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.005
70859632|NCT04626310|141205879|SUPERIORITY||Linear slope difference DBT-IE-IP|-0.111|STANDARD_ERROR_OF_MEAN|0.103||0.281|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of change in this interaction effect were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.281
70859633|NCT04626310|141205879|SUPERIORITY||Linear slope difference DBT-ER-DBT-IE|-0.18|STANDARD_ERROR_OF_MEAN|0.098||0.066|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of change in this interaction effect were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.066
70859634|NCT04626310|141205880|SUPERIORITY||Linear slope difference DBT-ER-IP|1.049|STANDARD_ERROR_OF_MEAN|0.653||0.108|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of the effect of negative maintain vs. neutral images on weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.108
70859635|NCT04626310|141205880|SUPERIORITY||Linear slope difference DBT-IE-IP|-1.21|STANDARD_ERROR_OF_MEAN|0.454||0.014|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of the effect of negative maintain vs. neutral images on weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.014
70859636|NCT04626310|141205880|SUPERIORITY||Linear slope difference DBT-ER-DBT-IE|2.17|STANDARD_ERROR_OF_MEAN|0.631||0.001|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of the effect of negative maintain vs. neutral images on weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.001
70859637|NCT04626310|141205881|OTHER||Linear Slope difference DBT-ER-IP|0.17|STANDARD_ERROR_OF_MEAN|0.136||0.211|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of the effect of negative maintain vs. negative decrease on weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.211
70947024|NCT01777126|141394216|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.0|||<|0.01|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using the Wilcoxon rank sum test. The result was considered statistically significant if p-values were \< 0.05.||||<0.01
70859638|NCT04626310|141205881|SUPERIORITY||Linear Slope difference DBT-IE-IP|-0.195|STANDARD_ERROR_OF_MEAN|0.135||0.148|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of the effect of negative maintain vs. negative decrease on weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.148
70859639|NCT04626310|141205881|SUPERIORITY||Linear Slope difference DBT-ER-DBT-IE|-0.025|STANDARD_ERROR_OF_MEAN|0.137||0.857|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of the effect of negative maintain vs. negative decrease on weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.857
70859640|NCT04626310|141205882|SUPERIORITY||Linear Slope Difference in DSS DBT-ER-IP|-0.313|STANDARD_ERROR_OF_MEAN|0.794||0.693|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DSS over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.693
70859641|NCT04626310|141205882|SUPERIORITY||Linear Slope Difference in DSS DBT-IE-IP|0.002|STANDARD_ERROR_OF_MEAN|0.767||0.998|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DSS over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.998
70859642|NCT04626310|141205882|SUPERIORITY||Linear Slope Diff in DSS DBT-ER-DBT-IE|-0.315|STANDARD_ERROR_OF_MEAN|0.765||0.68|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DSS over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.680
70859643|NCT04626310|141205882|SUPERIORITY||Linear Slope Difference in DC1 DBT-ER-IP|0.098|STANDARD_ERROR_OF_MEAN|0.101||0.333|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC1 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.333
70859644|NCT04626310|141205882|SUPERIORITY||Linear Slope Diff in DC1 DBT-IE-IP|-0.046|STANDARD_ERROR_OF_MEAN|0.097||0.632|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC1 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.632
70859645|NCT04626310|141205882|SUPERIORITY||Linear Slope Diff in DC1 DBT-ER-DBT-IE|0.144|STANDARD_ERROR_OF_MEAN|0.107||0.178|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC1 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to DBT-ER.||||.178
70859646|NCT04626310|141205882|SUPERIORITY||Linear Slope Diff in DC2 DBT-ER-IP|0.045|STANDARD_ERROR_OF_MEAN|0.112||0.689|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC2 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared the slope differences DBT-ER to IP.||||.689
70859647|NCT04626310|141205882|SUPERIORITY||Linear Slope Diff in DC2 DBT-IE-IP|-0.011|STANDARD_ERROR_OF_MEAN|0.109||0.917|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC2 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared the slope differences DBT-IE to IP.||||.917
70947025|NCT01777126|141394217|SUPERIORITY_OR_OTHER||proportion|||||0.487||95.0|||||Fisher Exact|||Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using Chi-square and Fisher's Exact Test. Results were considered statistically significant if p-values were \< 0.05.||||0.487
70859648|NCT04626310|141205882|SUPERIORITY||Linear Slope Diff in DC2 DBT-ER-DBT-IE|0.056|STANDARD_ERROR_OF_MEAN|0.108||0.603|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC2 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared the slope differences DBT-ER to DBT-IE.||||.603
70947026|NCT01777126|141394218|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.302|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.302
70859649|NCT04626310|141205883|SUPERIORITY||Other[Quad Slope difference DBT-ER-IP]|0.013|STANDARD_ERROR_OF_MEAN|0.044||0.762|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-ER vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.762
71130519|NCT04302545|141764942|OTHER|Other Primary outcomes were the extent of injury, operative time, blood loss and proportion of subjects receiving a blood transfusion. Postoperatively, subjects were assessed for secondary outcomes of UTI, micturition problems, and fistula formation during the hospital stay and for the next 3 months. Postoperative micturition problems were feeling of incomplete evacuation, frequency, urgency, urethral and extra-urethral incontinence.|Odds Ratio (OR)|-0.178|||<|0.0001|TWO_SIDED|95.0|-0.261|-0.094||The threshold for statistical significance was \<.05.|Regression, Linear|||"Null Hypothesis: During the cesarean section of women with adhesions of the previous cesarean section that obscure the bladder, the bladder injury rate is not significantly decreased in cystoinflation group compared to the control.~In this study, the bladder injury rate was seven times lesser in cystoinflation group compared to the control, thereby strongly supporting our hypothesis. The power of the study for bladder injury was 0.988, calculated with statistical software G'Power version 3.1."||-.094|-.261|<.0001
70859650|NCT04626310|141205883|SUPERIORITY||Quad Slope difference DBT-IE-IP|0.034|STANDARD_ERROR_OF_MEAN|0.047||0.478|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-IE vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.478
70859651|NCT04626310|141205883|SUPERIORITY||Quad Slope difference DBT-ER-DBT-IE|-0.089|STANDARD_ERROR_OF_MEAN|0.054||0.705|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-ER vs. DBT-IE) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.705
70859652|NCT04626310|141205884|SUPERIORITY||Quad slope difference DBT-ER-IP|-0.028|STANDARD_ERROR_OF_MEAN|0.15||0.93|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-ER vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.93
70947027|NCT01777126|141394219|SUPERIORITY_OR_OTHER||Proportion|||||0.117|TWO_SIDED|95.0|||||Fisher Exact|||Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using Fisher's Exact Test. The result was considered statistically significant if p-values were \< 0.05.||||0.117
70859653|NCT04626310|141205884|SUPERIORITY||Quad slope difference DBT-IE-IP|-0.029|STANDARD_ERROR_OF_MEAN|0.145||0.836|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-IE vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.836
70859654|NCT04626310|141205884|SUPERIORITY||Quad slope difference DBT-ER-DBT-IE|0.001|STANDARD_ERROR_OF_MEAN|0.145||0.994|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-IE vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.994
70859655|NCT04626310|141205885|SUPERIORITY||Quad slope diff in DC1 DBT-ER-IP|0.013|STANDARD_ERROR_OF_MEAN|0.013||0.313|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC1 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared the quadratic effects differed DBT-ER to IP.||||.313
70859656|NCT04626310|141205885|SUPERIORITY||Quad Slope in DC1 DBT-IE-IP|0.003|STANDARD_ERROR_OF_MEAN|0.01||0.747|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC1 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared the quadratic effects differed DBT-IE to IP.||||.747
70859657|NCT04626310|141205885|SUPERIORITY||Quad slope diff in DC1 DBT-ER-DBT-IE|0.009|STANDARD_ERROR_OF_MEAN|0.012||0.444|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC1 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared the quadratic effects differed DBT-ER to DBT-IE.||||.444
70859658|NCT02278341|141205886|NON_INFERIORITY|Non Inferiority, Margin = -0.75|LSM Difference|0.235|||<|0.001|TWO_SIDED|95.0|0.132|0.339||p-value for non-inferiority test based on 1-sided significance level.|Mixed Models Analysis|||The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb and baseline Hb by visit as continuous variable.||0.339|0.132|<0.001
70947028|NCT01777126|141394220|SUPERIORITY_OR_OTHER||Proportion|||||0.049||95.0|||||Chi-squared|||Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using Chi-square Test. Outcome measures were considered statistically significant if p-values were \< 0.05.||||0.049
71130520|NCT04302545|141764943|OTHER||Odds Ratio (OR)|-211.776|||<|0.0001|TWO_SIDED|95.0|-290.7|-132.84|||Regression, Linear|||||-132.84|-290.70|<0.0001
71130521|NCT04302545|141764944|OTHER||Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|-3.634|3.634|||Regression, Linear|||Null Hypothsis:Cystoinflation is ineffective to prevent bladder injury in adhesions of previous C-section.The cystoinflation was to be cosidered ineffective if proportion of bladder injury in study group was less than %0% of the control.The power of the study for bladder injury prevention was.988,calculated with statistical software G'Power version3.1.||3.634|-3.634|1
70859659|NCT02278341|141205887|NON_INFERIORITY|Non-Inferiority, Margin = -0.75|LSM Difference|0.171|||<|0.001|TWO_SIDED|95.0|0.082|0.261||p-value for non-inferiority test based on 1-sided significance level.|ANCOVA|||The model includes treatment arm, region, CV History, previous ESA treatment as categorical variables and baseline Hb as continuous variable. Statistical analysis used was ANCOVA model with multiple imputations (MI). Missing hemoglobin data was imputed for each treatment relying on non-missing data from all participants within each treatment group using the MCMC imputation model.||0.261|0.082|<0.001
70859660|NCT02278341|141205888|NON_INFERIORITY|Non-inferiority of roxadustat versus ESA (the non-inferiority margin for the difference between groups is -15%).|Difference of Percentages|2.3|||<|0.05|TWO_SIDED|95.0|-2.9|7.6||p-value for non-inferiority test based on 1-sided significance level.|Miettinen and Nurminen|||A generalized linear model was used to estimate the difference in response rates between the arms, as an approximation for the Miettinen and Nurminen method, adjusting for following covariates: region, previous ESA treatment, cardiovascular history and baseline Hb as categorical variables.||7.6|-2.9|<0.05
70859661|NCT02278341|141205889|SUPERIORITY||LSM Difference|-0.377|||<|0.001|TWO_SIDED|95.0|-0.451|-0.304||p-value for superiority test based on 2-sided significance level|Mixed Models Analysis|||The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline LDL, baseline Hb as continuous variables.||-0.304|-0.451|<0.001
70859662|NCT02278341|141205890|SUPERIORITY||LSM Difference|-31.9|||<|0.001|TWO_SIDED|95.0|-41.4|-22.4||p-value for superiority test based on 2-sided significance level|ANCOVA|||The model includes treatment arm, region, CV History, previous ESA treatment as categorical variables and baseline Hb as continuous variable.||-22.4|-41.4|<0.001
71130522|NCT04302545|141764945|OTHER||Odds Ratio (OR)|-1.093||||0.001|TWO_SIDED|95.0|-1.708|-0.479|||Regression, Linear|||||-.479|-1.708|.001
71130523|NCT04302545|141764946|OTHER||Odds Ratio (OR)|-0.15|||<|0.0001|TWO_SIDED|95.0|-0.226|-0.073|||Regression, Linear|||||-0.073|-0.226|<0.0001
71130524|NCT04302545|141764947|OTHER||Odds Ratio (OR)|-0.103||||0.003|TWO_SIDED|95.0|-0.171|-0.035|||Regression, Linear|||||-0.035|-0.171|0.003
71130525|NCT04302545|141764948|OTHER||Odds Ratio (OR)|0.654||||0.336|TWO_SIDED|95.0|-0.682|1.991|||Regression, Linear|||||1.991|-0.682|.336
71130526|NCT04302545|141764949|OTHER||Odds Ratio (OR)|-0.393||||0.021|TWO_SIDED|95.0|-0.725|-0.06|||Regression, Linear|||||-0.06|-0.725|.021
70947029|NCT01777126|141394221|SUPERIORITY_OR_OTHER||proportion|||||0.698||95.0|||||Chi-squared|||Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using Chi-square Test. Outcome measures were considered statistically significant if p-values were \< 0.05.||||0.698
70947030|NCT01086384|141394289|SUPERIORITY_OR_OTHER||Regression Cox|0.795|||||TWO_SIDED|95.0|0.642|0.985|||||The estimated values is the Hazard ratio obtained from the Cox regression analysis for FF/VI 100/25 µg versus FF 100 µg, adjusted for an interim analysis.|||0.985|0.642|
70859663|NCT02278341|141205891|NON_INFERIORITY|The margin for non-inferiority was -3.|LSM Difference|0.205|||<|0.05|TWO_SIDED|95.0|-0.649|1.059||p-value for non-inferiority test based on 1-sided significance level|Mixed Models Analysis|||The model includes treatment arm, region, CV History, previous ESA treatment, visits (week 8, week 12, week 28) and visit by treatment as categorical variables, and baseline SF-36 PF, baseline Hb as continuous variables.||1.059|-0.649|<0.05
70859664|NCT02278341|141205892|NON_INFERIORITY|The margin for non-inferiority was -3.|LSM Difference|0.856|||<|0.05|TWO_SIDED|95.0|-0.115|1.828|||Mixed Models Analysis|||The model includes treatment arm, region, CV History, previous ESA treatment, visits (week 8, week 12, week 28) and visit by treatment as categorical variables, and baseline SF-36 VT, baseline Hb as continuous variables.||1.828|-0.115|<0.05
71130527|NCT04302545|141764950|OTHER||Odds Ratio (OR)|-1.89|||<|0.0001|TWO_SIDED|95.0|-2.813|-0.963|||Regression, Linear|||||-0.963|-2.813|<0.0001
71130528|NCT04302545|141764951|OTHER||Odds Ratio (OR)|-1.318|||<|0.0001|TWO_SIDED|95.0|-2.021|-0.614|||Regression, Linear|||||-0.614|-2.021|<.0001
71130529|NCT04302545|141764953|OTHER||Odds Ratio (OR)|-0.065||||0.003|TWO_SIDED|95.0|-0.108|-0.023|||Regression, Linear|||||-.023|-.108|.003
71130530|NCT02106403|141764990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.46||||0.0659|TWO_SIDED|95.0|-0.37|11.29|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus negative control such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||11.29|-0.37|0.0659
71130531|NCT02106403|141764990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.99||||0.0928|TWO_SIDED|95.0|-0.84|10.81|||ANCOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the reference product minus negative control such that a positive difference showed improved cooling in the reference product.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||10.81|-0.84|0.0928
71130532|NCT02106403|141764990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.48||||0.8711|TWO_SIDED|95.0|-5.35|6.31|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus reference product such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||6.31|-5.35|0.8711
71130533|NCT02106403|141764991|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.43||||0.0016|TWO_SIDED|95.0|4.43|18.42|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus negative control such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||18.42|4.43|0.0016
71130534|NCT02106403|141764991|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.69||||0.6323|TWO_SIDED|95.0|-5.31|8.69|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the reference product minus negative control such that a positive difference showed improved cooling in the reference product.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||8.69|-5.31|0.6323
71130535|NCT02106403|141764991|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.73||||0.0069|TWO_SIDED|95.0|2.74|16.73|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus reference product such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||16.73|2.74|0.0069
71130536|NCT02106403|141764992|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.13|||<|0.0001|TWO_SIDED|95.0|6.23|18.04|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus negative control such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||18.04|6.23|<0.0001
71130537|NCT02106403|141764992|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.18||||0.4645|TWO_SIDED|95.0|-8.09|3.72|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the reference product minus negative control such that a positive difference showed improved cooling in the reference product.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||3.72|-8.09|0.4645
71130538|NCT02106403|141764992|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.32|||<|0.0001|TWO_SIDED|95.0|8.41|20.22|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus reference product such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||20.22|8.41|<0.0001
71130539|NCT02106403|141764993|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.41||||0.0357|TWO_SIDED|95.0|0.44|12.38|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus negative control such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||12.38|0.44|0.0357
71130540|NCT02106403|141764993|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.02||||0.503|TWO_SIDED|95.0|-3.95|8.0|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the reference product minus negative control such that a positive difference showed improved cooling in the reference product.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||8.00|-3.95|0.5030
71130541|NCT02106403|141764993|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.39||||0.1482|TWO_SIDED|95.0|-1.59|10.36|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus reference product such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||10.36|-1.59|0.1482
71130542|NCT04146935|141764995|OTHER|Mixed model repeated measures||||||0.4147||||||Visit 1 (baseline) to visit 4 (peak)|Mixed Models Analysis|||||||0.4147
71130543|NCT04146935|141764996|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
71130544|NCT04146935|141764997|OTHER|Mixed model repeated measures||||||0.6957|||||||Mixed Models Analysis|||||||0.6957
70859665|NCT02278341|141205893|NON_INFERIORITY|The margin for non-inferiority was 1.|LSM Difference|-0.849|||<|0.05|TWO_SIDED|95.0|-1.971|0.273||p-value for non-inferiority test based on 1-sided significance level|Mixed Models Analysis|||The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables, and baseline MAP, baseline Hb as continuous variables.||0.273|-1.971|<0.05
71130545|NCT04146935|141764998|OTHER|||||||0.0092|||||||Mixed Models Analysis|||||||0.0092
70859666|NCT02278341|141205894|NON_INFERIORITY|Non-inferiority (hazard ratio margin of 1.3).|Hazard Ratio (HR)|0.924|||<|0.05|TWO_SIDED|95.0|0.669|1.276||p-value for non-inferiority test based on 1-sided significance level.|Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on region, CV history, previous ESA treatment, and adjusting on Hb at baseline as continuous covariate. Non-inferiority was declared if the upper bound of the 95% CI is below 1.3.||1.276|0.669|<0.05
71130546|NCT04146935|141764999|OTHER|Mixed model repeated measures||||||0.1383|||||||Mixed Models Analysis|||||||0.1383
71130547|NCT04146935|141765000|OTHER|mixed model repeated measures||||||0.0572|||||||Mixed Models Analysis|||||||0.0572
71130548|NCT04038567|141765001|SUPERIORITY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-1.14|1.2||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.20|-1.14|
71130549|NCT04038567|141765001|SUPERIORITY||Mean Difference (Final Values)|-1.22|||||TWO_SIDED|95.0|-2.39|-0.04||||||Values are change in model-estimated means for his vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||-0.04|-2.39|
71130550|NCT04038567|141765001|SUPERIORITY||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-1.12|1.23||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.23|-1.12|
71130551|NCT04038567|141765002|SUPERIORITY||Mean Difference (Net)|-1.14|||||TWO_SIDED|95.0|-2.12|-0.16||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||-0.16|-2.12|
71130552|NCT04038567|141765002|SUPERIORITY||Mean Difference (Final Values)|-0.82|||||TWO_SIDED|95.0|-1.8|1.49||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.49|-1.80|
71130553|NCT04038567|141765002|SUPERIORITY||Mean Difference (Final Values)|0.51|||||TWO_SIDED|95.0|-0.48|1.49||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.49|-0.48|
71130554|NCT04038567|141765003|SUPERIORITY||Mean Difference (Final Values)|-0.32|||||TWO_SIDED|95.0|-1.66|1.01||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.01|-1.66|
71130555|NCT04038567|141765003|SUPERIORITY||Mean Difference (Final Values)|-1.47|||||TWO_SIDED|95.0|-2.81|-0.14||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||-0.14|-2.81|
71130556|NCT04038567|141765003|SUPERIORITY||Mean Difference (Final Values)|0.82|||||TWO_SIDED|95.0|-0.52|2.15||||||Values are change in model-estimated means for therapist vs. app response to symptoms. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||2.15|-0.52|
71130557|NCT04038567|141765004|SUPERIORITY||Mean Difference (Final Values)|-0.16|||||TWO_SIDED|95.0|-1.23|0.91||||||||0.91|-1.23|
71130558|NCT04038567|141765004|SUPERIORITY||Mean Difference (Final Values)|-1.22|||||TWO_SIDED|95.0|-2.29|-0.15||||||||-0.15|-2.29|
71130559|NCT04038567|141765004|SUPERIORITY||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-1.77|0.37||||||||0.37|-1.77|
71130560|NCT04038567|141765005|SUPERIORITY||Mean Difference (Final Values)|-1.58|||||TWO_SIDED|95.0|-4.41|1.25||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.25|-4.41|
71130561|NCT04038567|141765005|SUPERIORITY||Mean Difference (Final Values)|-0.42|||||TWO_SIDED|95.0|-3.26|2.42||||||Values are change in model-estimated means for hig vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||2.42|-3.26|
71130562|NCT04038567|141765005|SUPERIORITY||Mean Difference (Final Values)|1.49|||||TWO_SIDED|95.0|-1.35|4.33||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||4.33|-1.35|
71130563|NCT04038567|141765010|SUPERIORITY||Mean Difference (Final Values)|0.58|||||TWO_SIDED|95.0|-0.62|1.78||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.78|-0.62|
70859667|NCT02278341|141205895|SUPERIORITY||LSM Difference|-0.579|||=|0.308|TWO_SIDED|95.0|-1.694|0.536||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables, and baseline MAP, baseline Hb as continuous variables.||0.536|-1.694|=0.308
71130564|NCT04038567|141765010|SUPERIORITY||Mean Difference (Final Values)|0.73|||||TWO_SIDED|95.0|-0.47|1.92||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.92|-0.47|
71130565|NCT04038567|141765010|SUPERIORITY||Mean Difference (Final Values)|0.19|||||TWO_SIDED|95.0|-1.0|1.39||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.39|-1.00|
71130566|NCT04038567|141765011|SUPERIORITY||Mean Difference (Final Values)|0.91|||||TWO_SIDED|95.0|-0.45|2.27||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||2.27|-0.45|
71130567|NCT04038567|141765011|SUPERIORITY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-1.33|1.38||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.38|-1.33|
71130568|NCT04038567|141765011|SUPERIORITY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-1.72|0.99||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||0.99|-1.72|
71130569|NCT04038567|141765012|SUPERIORITY||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-1.3|0.3||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||0.30|-1.30|
71130570|NCT04038567|141765012|SUPERIORITY||Mean Difference (Final Values)|-0.53|||||TWO_SIDED|95.0|-1.33|0.27||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||0.27|-1.33|
71130571|NCT04038567|141765012|SUPERIORITY||Mean Difference (Final Values)|0.25|||||TWO_SIDED|95.0|-0.55|1.05||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.05|-.55|
71130572|NCT04038567|141765013|SUPERIORITY||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-1.41|0.41||||||||0.41|-1.41|
71130573|NCT04038567|141765013|SUPERIORITY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-1.27|0.55||||||||0.55|-1.27|
71130574|NCT04038567|141765013|SUPERIORITY||Mean Difference (Final Values)|0.51|||||TWO_SIDED|95.0|-0.4|1.42||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.42|-0.40|
71130575|NCT04038567|141765014|SUPERIORITY||Mean Difference (Final Values)|2.33|||||TWO_SIDED|95.0|-3.25|7.91||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||7.91|-3.25|
70947031|NCT01086384|141394289|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|15.9||||0.036|TWO_SIDED|95.0|13.5|18.2||P-value for the Hazard ratio obtained from the Cox regression analysis for FF/VI 100/25 µg versus FF 100 µg, adjusted for an interim analysis.|Regression, Cox||The estimated value represents the adjusted probability of 1 or more severe asthma exacerbations by Week 52 for FF 100 µg. Cox Proportional Hazards Model estimate at mean Baseline FEV1, age, and proportional coefficients for sex and region.|||18.2|13.5|0.036
70947032|NCT01086384|141394289|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|12.8||||0.036|TWO_SIDED|95.0|10.7|14.9||P-value for the Hazard ratio obtained from the Cox regression analysis for FF/VI 100/25 µg versus FF 100 µg, adjusted for an interim analysis.|Regression, Cox||The estimated value represents the adjusted probability of 1 or more severe asthma exacerbations by Week 52 for FF/VI 100/25 µg. Cox Proportional Hazards Model estimate at mean Baseline FEV1, age, and proportional coefficients for sex and region.|||14.9|10.7|0.036
71130576|NCT04038567|141765014|SUPERIORITY||Mean Difference (Final Values)|4.82|||||TWO_SIDED|95.0|-0.76|10.4||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||10.40|-0.76|
71130577|NCT04038567|141765014|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-5.6|5.56||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||5.56|-5.60|
71130578|NCT04038567|141765015|SUPERIORITY||Mean Difference (Final Values)|3.18|||||TWO_SIDED|95.0|-3.01|9.37||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||9.37|-3.01|
71130579|NCT04038567|141765015|SUPERIORITY||Mean Difference (Final Values)|1.28|||||TWO_SIDED|95.0|-4.92|7.47||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||7.47|-4.92|
71130580|NCT04038567|141765015|SUPERIORITY||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-6.09|6.3||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||6.30|-6.09|
71130581|NCT04038567|141765022|SUPERIORITY||Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-5.26|-0.13||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||-0.13|-5.26|
71130582|NCT04038567|141765022|SUPERIORITY||Mean Difference (Final Values)|-1.89|||||TWO_SIDED|95.0|-4.46|0.67||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||0.67|-4.46|
71130583|NCT04038567|141765022|SUPERIORITY||Mean Difference (Final Values)|-0.74|||||TWO_SIDED|95.0|-3.31|1.83||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.83|-3.31|
71130584|NCT03533244|141765025|SUPERIORITY|||||||0.218||||||To reserve the family-wise error rate, the main treatment effect will be first assessed at the global level at alpha = 0.05. If this is significant, then pairwise comparisons will be conducted using the Bonferroni adjustment for multiplicity.|Mixed Models Analysis|||An empirical sample size estimation was used as this was an exploratory study. The null hypothesis is that there is no difference between AG-86893 and AG-86893 Vehicle. It is expected that the active group is at least 50% better than the vehicle.||||0.218
71130585|NCT03533244|141765025|SUPERIORITY|||||||0.29|||||||Mixed Models Analysis|||||||0.290
71130586|NCT03533244|141765026|SUPERIORITY|||||||0.193|||||||Mixed Models Analysis|||||||0.193
71130587|NCT03533244|141765026|SUPERIORITY|||||||0.399|||||||Mixed Models Analysis|||||||0.399
71130588|NCT03533244|141765027|SUPERIORITY|||||||0.015|||||||Fisher Exact|||||||0.015
71130589|NCT03533244|141765027|SUPERIORITY|||||||0.022|||||||Fisher Exact|||||||0.022
71130590|NCT01496846|141765028|SUPERIORITY|||||||0.901|||||||Chi-squared|We used the Chi-Square Test or Fisher's Exact test on the raw data depending on the number of data points in the table cells.||||||.901
71130591|NCT01496846|141765028|SUPERIORITY|||||||0.004|||||||Chi-squared|We used the Chi-Square Test or Fisher's Exact test on the raw data depending on the number of data points in the table cells.||||||.004
71130592|NCT01496846|141765029|SUPERIORITY|||||||0.437|||||||Chi-squared|We used the Chi-Square Test or Fisher's Exact test on the raw data depending on the number of data points in the table cells.||||||.437
71130593|NCT02024724|141765036|SUPERIORITY||Median Difference (Final Values)|-30.0||||0.196|TWO_SIDED|95.0|-45.0|10.0|||Chi-squared|||||10.00|-45.00|.196
71130594|NCT02019875|141765053|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.884|TWO_SIDED|95.0|-21.2|18.3|||Mixed Models Analysis|||||18.3|-21.2|0.884
71130595|NCT02019875|141765053|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.955|TWO_SIDED|95.0|-19.5|20.7|||Mixed Models Analysis|||||20.7|-19.5|0.955
71130596|NCT02019875|141765053|SUPERIORITY||Mean Difference (Final Values)|-6.4||||0.53|TWO_SIDED|95.0|-26.5|13.6|||Mixed Models Analysis|||||13.6|-26.5|0.53
71130597|NCT02019875|141765053|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.434|TWO_SIDED|95.0|-27.6|11.9|||Mixed Models Analysis|||||11.9|-27.6|0.434
71130598|NCT02019875|141765053|SUPERIORITY||Mean Difference (Final Values)|-2.8||||0.796|TWO_SIDED|95.0|-24.2|18.6|||Mixed Models Analysis|||||18.6|-24.2|0.796
71130599|NCT02019875|141765054|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.62|TWO_SIDED|95.0|-6.0|3.6|||Mixed Models Analysis|||||3.6|-6.0|0.62
71130600|NCT02019875|141765054|SUPERIORITY||Mean Difference (Final Values)|1.8||||0.482|TWO_SIDED|95.0|-3.1|6.7|||Mixed Models Analysis|||||6.7|-3.1|0.482
71130601|NCT02019875|141765054|SUPERIORITY||Mean Difference (Final Values)|1.5||||0.559|TWO_SIDED|95.0|-3.4|6.4|||Mixed Models Analysis|||||6.4|-3.4|0.559
71130602|NCT02019875|141765054|SUPERIORITY||Mean Difference (Final Values)|3.7||||0.138|TWO_SIDED|95.0|-1.2|8.5|||Mixed Models Analysis|||||8.5|-1.2|0.138
71130603|NCT02019875|141765054|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.477|TWO_SIDED|95.0|-7.1|3.3|||Mixed Models Analysis|||||3.3|-7.1|0.477
71130604|NCT02019875|141765055|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.98|TWO_SIDED|95.0|-11.0|11.3|||Mixed Models Analysis|||||11.3|-11.0|0.98
70954362|NCT03568318|141411393|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|50.6|||<|0.001|TWO_SIDED|95.0|43.8|57.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||57.4|43.8|<0.001
70859668|NCT02278341|141205896|SUPERIORITY||Hazard Ratio (HR)|0.915|||=|0.582|TWO_SIDED|95.0|0.668|1.254||p-value for superiority test based on 2-sided significance level.|Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on region, CV history, previous ESA treatment, and adjusting on Hb at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI is lower than 1.||1.254|0.668|=0.582
70859669|NCT02278341|141205897|SUPERIORITY||Difference of Percentages|1.4|||=|0.609|TWO_SIDED|95.0|-3.8|6.5||p-value for superiority test based on 2-sided significance level|Miettinen and Nurminen method|||A generalized linear model was used to estimate the difference in response rates between the arms, as an approximation for the Miettinen and Nurminen method, adjusting for following covariates: region, previous ESA treatment, cardiovascular history and baseline Hb as categorical variables.||6.5|-3.8|=0.609
70859670|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.164|||<|0.001|TWO_SIDED|95.0|0.072|0.256||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 1- The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.256|0.072|<0.001
70859671|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.443|||<|0.001|TWO_SIDED|95.0|0.339|0.546||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 2- The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.546|0.339|<0.001
70859672|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.561|||<|0.001|TWO_SIDED|95.0|0.451|0.672||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 3 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.672|0.451|<0.001
70859673|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.708|||<|0.001||95.0|0.588|0.828||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 4 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.828|0.588|<0.001
70947033|NCT01196819|141394292|NON_INFERIORITY|Non-inferiority margin is 0.13mm, if the two-sided upper 95% confidence bound is \<Δ, the Firehawk Stent being tested will be considered non-inferior to the control. This corresponds to a P value \<0.05 from a two-sided Student t-test comparing the difference between FirehawkStent and Xience stent to delta.|Mean Difference (Final Values)|0.17||||0.94|TWO_SIDED|95.0|0.0|0.29|||ANCOVA|||H0: Pe - Pc≥ ∆, H1: Pe - Pc \< ∆. Pe and Pc are the mean 9-month in-stent late loss for the subject in the Firehawk DES group and the Xience group, respectively. ∆ is the non-inferiority margin. A two-sided upper 95% confidence bound will be calculated for the difference in 9-month in-stent late loss .||0.29|0|0.94
70947034|NCT01196819|141394293|NON_INFERIORITY|Assume the in-stent percent diameter stenosis of both FIREHAWK and XIENCE V are 16 ± 16%, the non-inferiority value is 5%, the level of statistical significance is 0.05 (bilateral test), the power is 85%.||||||0.69|||||||Mixed Models Analysis|||||||0.69
70947035|NCT01196819|141394294|OTHER|||||||1|||||||Fisher Exact|||||||1.0
70859674|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.768|||<|0.001|TWO_SIDED|95.0|0.645|0.89||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 5 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.890|0.645|<0.001
70859675|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.729|||<|0.001|TWO_SIDED|95.0|0.604|0.855||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 6 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.855|0.604|<0.001
70859676|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.729|||<|0.001|TWO_SIDED|95.0|0.603|0.856||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 7 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.856|0.603|<0.001
70859677|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.574|0.826||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 8 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.826|0.574|<0.001
70859678|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.659|||<|0.001|TWO_SIDED|95.0|0.53|0.788||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 10 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.788|0.530|<0.001
70859679|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.593|||<|0.001|TWO_SIDED|95.0|0.459|0.727||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 12 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.727|0.459|<0.001
70947036|NCT01196819|141394295|OTHER|||||||0.76|||||||Fisher Exact|||||||0.76
70859680|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.503|||<|0.001|TWO_SIDED|95.0|0.366|0.64||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 14 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.640|0.366|<0.001
70859681|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.369|||<|0.001|TWO_SIDED|95.0|0.229|0.51||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 16 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.510|0.229|<0.001
70947037|NCT01196819|141394296|OTHER|||||||0.77|||||||Fisher Exact|||||||0.77
70947038|NCT01196819|141394297|OTHER|||||||1|||||||Fisher Exact|||||||1.0
71130605|NCT02019875|141765055|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.81|TWO_SIDED|95.0|-10.0|12.7|||Mixed Models Analysis|||||12.7|-10.0|0.81
70859682|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.363|||<|0.001|TWO_SIDED|95.0|0.23|0.496||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 18 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.496|0.230|<0.001
70859683|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.284|||<|0.001|TWO_SIDED|95.0|0.154|0.414||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 20 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.414|0.154|<0.001
70859684|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.197|||=|0.003|TWO_SIDED|95.0|0.065|0.329||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 22 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.329|0.065|=0.003
70859685|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.187|||=|0.004|TWO_SIDED|95.0|0.059|0.316||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 24 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.316|0.059|=0.004
71130606|NCT02019875|141765055|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.91|TWO_SIDED|95.0|-10.8|12.2|||Mixed Models Analysis|||||12.2|-10.8|0.91
71130607|NCT02019875|141765055|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.68|TWO_SIDED|95.0|-8.9|13.8|||Mixed Models Analysis|||||13.8|-8.9|0.68
71130608|NCT02019875|141765055|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.96|TWO_SIDED|95.0|-11.9|12.6|||Mixed Models Analysis|||||12.6|-11.9|0.96
71130609|NCT02019875|141765056|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.17|TWO_SIDED|95.0|-2.7|0.5|||Mixed Models Analysis|||||0.5|-2.7|0.17
71130610|NCT02019875|141765056|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.44|TWO_SIDED|95.0|-1.0|2.2|||Mixed Models Analysis|||||2.2|-1.0|0.44
71130611|NCT02019875|141765056|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.94|TWO_SIDED|95.0|-1.7|1.6|||Mixed Models Analysis|||||1.6|-1.7|0.94
71130612|NCT02019875|141765056|SUPERIORITY||Mean Difference (Final Values)|3.7|||<|0.0001|TWO_SIDED|95.0|2.1|5.2|||Mixed Models Analysis|||||5.2|2.1|<0.0001
71130613|NCT02019875|141765056|SUPERIORITY||Mean Difference (Final Values)|3.9|||<|0.0001|TWO_SIDED|95.0|2.2|5.6|||Mixed Models Analysis|||||5.6|2.2|<0.0001
71130614|NCT02019875|141765057|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.43|TWO_SIDED|95.0|-0.027|0.012|||Mixed Models Analysis|||||0.012|-0.027|0.43
71130615|NCT02019875|141765057|SUPERIORITY||Mean Difference (Final Values)|-0.017||||0.09|TWO_SIDED|95.0|-0.037|0.003|||Mixed Models Analysis|||||0.003|-0.037|0.09
71130616|NCT02019875|141765057|SUPERIORITY||Mean Difference (Final Values)|-0.011||||0.29|TWO_SIDED|95.0|-0.031|0.009|||Mixed Models Analysis|||||0.009|-0.031|0.29
71130617|NCT02019875|141765057|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.61|TWO_SIDED|95.0|-0.025|0.015|||Mixed Models Analysis|||||0.015|-0.025|0.61
71130618|NCT02019875|141765057|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.46|TWO_SIDED|95.0|-0.03|0.014|||Mixed Models Analysis|||||0.014|-0.03|0.46
71130619|NCT02019875|141765058|SUPERIORITY||Mean Difference (Final Values)|-12.6||||0.53|TWO_SIDED|95.0|-52.0|26.7|||Mixed Models Analysis|||||26.7|-52.0|0.53
71130620|NCT02019875|141765058|SUPERIORITY||Mean Difference (Final Values)|-44.5||||0.03|TWO_SIDED|95.0|-84.5|-4.5|||Mixed Models Analysis|||||-4.5|-84.5|0.03
71130621|NCT02019875|141765058|SUPERIORITY||Mean Difference (Final Values)|-7.2||||0.72|TWO_SIDED|95.0|-47.3|32.8|||Mixed Models Analysis|||||32.8|-47.3|0.72
71130622|NCT02019875|141765058|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.89|TWO_SIDED|95.0|-36.6|42.2|||Mixed Models Analysis|||||42.2|-36.6|0.89
71130623|NCT02019875|141765058|SUPERIORITY||Mean Difference (Final Values)|38.0||||0.08|TWO_SIDED|95.0|-4.7|80.6|||Mixed Models Analysis|||||80.6|-4.7|0.08
71130624|NCT02019875|141765059|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.96|TWO_SIDED|95.0|-104.5|110.2|||Mixed Models Analysis|||||110.2|-104.5|0.96
71130625|NCT02019875|141765059|SUPERIORITY||Mean Difference (Final Values)|15.0||||0.79|TWO_SIDED|95.0|-94.2|124.2|||Mixed Models Analysis|||||124.2|-94.2|0.79
71130626|NCT02019875|141765059|SUPERIORITY||Mean Difference (Final Values)|71.3||||0.2|TWO_SIDED|95.0|-37.9|180.5|||Mixed Models Analysis|||||180.5|-37.9|0.20
71130627|NCT02019875|141765059|SUPERIORITY||Mean Difference (Final Values)|-2.7||||0.96|TWO_SIDED|95.0|-110.1|104.7|||Mixed Models Analysis|||||104.7|-110.1|0.96
71130628|NCT02019875|141765059|SUPERIORITY||Mean Difference (Final Values)|51.8||||0.38|TWO_SIDED|95.0|-64.7|168.2|||Mixed Models Analysis|||||168.2|-64.7|0.38
71130629|NCT03202134|141765064|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71130630|NCT03202134|141765065|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71130631|NCT03202134|141765066|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71130632|NCT03202134|141765067|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71130633|NCT03202134|141765068|SUPERIORITY|||||||0.048|||||||Wilcoxon (Mann-Whitney)|||||||0.048
71130634|NCT01371734|141765070|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.85||||0.587|TWO_SIDED|95.0|-2.23|3.94|||Mixed-effects model for repeated measure|Hochberg procedure was used to control for multiplicity||Adjusted mean difference = Placebo - DVS SR Low Dose||3.94|-2.23|0.587
71130635|NCT01371734|141765070|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.52||||0.333|TWO_SIDED|95.0|-1.56|4.61|||Mixed-effects model for repeated measure|Hochberg procedure was used to control for multiplicity||Adjusted mean difference = Placebo - DVS SR High Dose||4.61|-1.56|0.333
71130636|NCT01371734|141765071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.015||||0.923|TWO_SIDED|95.0|-0.29|0.32|||Mixed-effects model for repeated measure|Hochberg procedure was used to control for multiplicity||Adjusted mean difference = Placebo - DVS SR Low Dose||0.32|-0.29|0.923
71130637|NCT01371734|141765071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.161||||0.302|TWO_SIDED|95.0|-0.14|0.47|||Mixed-effects model for repeated measure|Hochberg procedure was used to control for multiplicity||Adjusted mean difference = Placebo - DVS SR High Dose||0.47|-0.14|0.302
71130638|NCT01371734|141765072|SUPERIORITY_OR_OTHER|||||||0.729|||||||Cochran-Mantel-Haenszel|||Week 1||||0.729
71130639|NCT01371734|141765072|SUPERIORITY_OR_OTHER|||||||0.756|||||||Cochran-Mantel-Haenszel|||Week 1||||0.756
71130640|NCT01371734|141765072|SUPERIORITY_OR_OTHER|||||||0.765|||||||Cochran-Mantel-Haenszel|||Week 2||||0.765
71130641|NCT01371734|141765072|SUPERIORITY_OR_OTHER|||||||0.475|||||||Cochran-Mantel-Haenszel|||Week 2||||0.475
71130642|NCT01371734|141765072|SUPERIORITY_OR_OTHER|||||||0.31|||||||Cochran-Mantel-Haenszel|||Week 3||||0.310
71130643|NCT01371734|141765072|SUPERIORITY_OR_OTHER|||||||0.105|||||||Chi-squared, Corrected|||Week 3||||0.105
71130644|NCT01371734|141765072|SUPERIORITY_OR_OTHER|||||||0.254|||||||Cochran-Mantel-Haenszel|||Week 4||||0.254
71130645|NCT01371734|141765072|SUPERIORITY_OR_OTHER|||||||0.887|||||||Cochran-Mantel-Haenszel|||Week 4||||0.887
71130646|NCT01371734|141765072|SUPERIORITY_OR_OTHER|||||||0.475|||||||Cochran-Mantel-Haenszel|||Week 6||||0.475
71130647|NCT01371734|141765072|SUPERIORITY_OR_OTHER|||||||0.407|||||||Cochran-Mantel-Haenszel|||Week 6||||0.407
71130648|NCT01371734|141765072|SUPERIORITY_OR_OTHER|||||||0.696|||||||Cochran-Mantel-Haenszel|||Week 8||||0.696
70859686|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.243|||<|0.001|TWO_SIDED|95.0|0.113|0.373||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 26 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.373|0.113|<0.001
70859687|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.207|||=|0.002|TWO_SIDED|95.0|0.074|0.34||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 28 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.340|0.074|=0.002
70859688|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.227|||<|0.001|TWO_SIDED|95.0|0.096|0.358||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 30 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.358|0.096|<0.001
70947039|NCT02250534|141394300|SUPERIORITY||Mean Difference (Net)|-5.33|STANDARD_ERROR_OF_MEAN|1.06|<|0.0001|TWO_SIDED|95.0|-7.41|-3.26||The p-value is Bonferroni-corrected for multiple comparisons with a priori threshold of significance P \< 0.0167|ANCOVA||Group difference = 0.12 mg nicotine - 0.8 mg nicotine|The statistical analysis method was ANCOVA, in order to test for statistically significant differences between group means, while controlling for covariates of interest. It was calculated that 207 subjects per group would be required to have at least 90% power to detect a mean difference of 4.52 CPD between the 0.8 mg and 0.12 mg groups at week 12, with significance level alpha of 0.0167. The significance level reflects the Bonferroni correction needed for testing of all pairwise comparisons.||-3.26|-7.41|<0.0001
70947040|NCT02250534|141394300|SUPERIORITY||Mean Difference (Net)|-7.54|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|-9.51|-5.57||The p-value is Bonferroni-corrected for multiple comparisons with a priori threshold of significance P \< 0.0167|ANCOVA||Group difference = 0.03 mg nicotine - 0.8 mg nicotine|The statistical analysis method was ANCOVA, in order to test for statistically significant differences between group means, while controlling for covariates of interest. It was calculated that 207 subjects per group would be required to have at least 90% power to detect a mean difference of 6.07 CPD between the 0.8 mg and 0.03 mg groups at week 12, with significance level alpha of 0.0167. The significance level reflects the Bonferroni correction needed for testing of all pairwise comparisons.||-5.57|-9.51|<0.0001
70859689|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.199|||=|0.004|TWO_SIDED|95.0|0.064|0.334|||Mixed Models Analysis|p-value for superiority test based on 2-sided significance level.||Week 32 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.334|0.064|=0.004
70859690|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.279|||<|0.001||95.0|0.15|0.409||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 34 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.409|0.150|<0.001
70947041|NCT03124550|141394312|OTHER|||||||0.0008|||||||Multilevel Modeling|||Multilevel modeling with the LMER package in R was used to determine whether participants changed in weekly average steps over the 6-week intervention.||||.0008
70947042|NCT03124550|141394313|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||Pre-test and post-test comparison||||.01
70947043|NCT03124550|141394314|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||Pre-test and post-test comparison||||.94
70947044|NCT03124550|141394315|OTHER|||||||0.0007|||||||Multilevel Modeling|||Multilevel modeling with the LMER package in R was used to determine whether participants changed in weekly number of social contact over the 6-week intervention.||||.0007
70947045|NCT00817336|141394347|SUPERIORITY_OR_OTHER||Cohen's d|0.8||||0.02|TWO_SIDED||||||Mixed Models Analysis|||||||0.02
70859691|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.256|||<|0.001|TWO_SIDED|95.0|0.121|0.391||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 36- The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.391|0.121|<0.001
70859692|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.136|||=|0.06|TWO_SIDED|95.0|-0.006|0.277||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 40 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.277|-0.006|=0.060
70859693|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.082|||=|0.293|TWO_SIDED|95.0|-0.071|0.236||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 44 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.236|-0.071|=0.293
70859694|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.027|||=|0.723|TWO_SIDED|95.0|-0.123|0.177||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 48 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.177|-0.123|=0.723
70859695|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.199|||=|0.009|TWO_SIDED|95.0|0.049|0.348||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 52 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.348|0.049|=0.009
70947046|NCT00817336|141394348|SUPERIORITY||Cohen's d|2.3||||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||0.001
70947047|NCT00817336|141394349|SUPERIORITY_OR_OTHER||Cohen's d|0.41||||0.31|TWO_SIDED||||||Mixed Models Analysis|||||||.31
70947048|NCT00817336|141394350|SUPERIORITY||Cohen's d|0.41||||0.41|TWO_SIDED||||||Mixed Models Analysis|||||||.41
71130649|NCT01371734|141765072|SUPERIORITY_OR_OTHER|||||||0.462|||||||Cochran-Mantel-Haenszel|||Week 8||||0.462
71130650|NCT01371734|141765073|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.806||||0.633|TWO_SIDED|95.0|0.333|1.951|||Regression, Logistic|||Week 1||1.951|0.333|0.633
71130651|NCT01371734|141765073|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.561||||0.172|TWO_SIDED|95.0|0.245|1.285|||Regression, Logistic|||Week 1||1.285|0.245|0.172
70859696|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.147|||=|0.056|TWO_SIDED|95.0|-0.004|0.298||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 56 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.298|-0.004|=0.056
70859697|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.196|||=|0.01|TWO_SIDED|95.0|0.047|0.346||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 60 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.346|0.047|=0.010
70859698|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.275|||<|0.001|TWO_SIDED|95.0|0.123|0.427||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 64 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.427|0.123|<0.001
70859699|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.206|||=|0.006|TWO_SIDED|95.0|0.059|0.353||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 68 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.353|0.059|=0.006
70859700|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.118|||=|0.127|TWO_SIDED|95.0|-0.033|0.269||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 72 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.269|-0.033|=0.127
70859701|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.211|||=|0.01|TWO_SIDED|95.0|0.051|0.371||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 76 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.371|0.051|=0.010
70859702|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.102|||=|0.191|TWO_SIDED|95.0|-0.051|0.255||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 80 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.255|-0.051|=0.191
70859703|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.192|||=|0.018|TWO_SIDED|95.0|0.033|0.351||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 84 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.351|0.033|=0.018
70859704|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.044|||=|0.576|TWO_SIDED|95.0|-0.111|0.2||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 88 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.200|-0.111|=0.576
70859705|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.203|||=|0.017|TWO_SIDED|95.0|0.037|0.369||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 92 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.369|0.037|=0.017
70859706|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.184|||=|0.019|TWO_SIDED|95.0|0.031|0.338||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 96 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.338|0.031|=0.019
70859707|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.164|||=|0.056||95.0|-0.004|0.333||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 100 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.333|-0.004|=0.056
70859708|NCT02278341|141205898|SUPERIORITY||LSM Difference|0.099|||=|0.267|TWO_SIDED|95.0|-0.076|0.273||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 104 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.273|-0.076|=0.267
70859709|NCT02278341|141205899|SUPERIORITY||LSM Difference|0.237|||<|0.001|TWO_SIDED|95.0|0.127|0.347||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Weeks 28-36 - The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb as continuous variable.||0.347|0.127|<0.001
70859710|NCT02278341|141205899|SUPERIORITY||LSM Difference|0.105|||=|0.086|TWO_SIDED|95.0|-0.015|0.225||p-value for superiority test based on 2-sided significance level|Mixed Models Analysis|||Weeks 44-52 - The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb as continuous variable.||0.225|-0.015|=0.086
70859711|NCT02278341|141205899|SUPERIORITY||LSM Difference|0.149|||=|0.031|TWO_SIDED|95.0|0.014|0.284||p-value for superiority test based on 2-sided significance level|Mixed Models Analysis|||Weeks 96-104 - The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb as continuous variable.||0.284|0.014|=0.031
70859712|NCT02278341|141205900|SUPERIORITY||LSM Difference|0.235|||<|0.001|TWO_SIDED|95.0|0.125|0.346|||Mixed Models Analysis|||Weeks 28-36 - The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb as continuous variable.||0.346|0.125|<0.001
70859713|NCT02278341|141205900|SUPERIORITY||LSM Difference|0.104|||=|0.11|TWO_SIDED|95.0|-0.024|0.232|||Mixed Models Analysis|||Weeks 44-52 - The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb as continuous variable.||0.232|-0.024|=0.110
70859714|NCT02278341|141205900|SUPERIORITY||LSM Difference|0.149|||=|0.036|TWO_SIDED|95.0|0.01|0.288|||Mixed Models Analysis|||Weeks 96-104 - The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb as continuous variable.||0.288|0.010|=0.036
71130652|NCT01371734|141765073|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.939||||0.826|TWO_SIDED|95.0|0.536|1.644|||Regression, Logistic|||Week 2||1.644|0.536|0.826
71130653|NCT01371734|141765073|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.599|TWO_SIDED|95.0|0.489|1.511|||Regression, Logistic|||Week 2||1.511|0.489|0.599
71130654|NCT01371734|141765073|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.713||||0.248|TWO_SIDED|95.0|0.402|1.265|||Regression, Logistic|||Week 3||1.265|0.402|0.248
71130655|NCT01371734|141765073|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.564||||0.048|TWO_SIDED|95.0|0.32|0.995|||Regression, Logistic|||Week 3||0.995|0.320|0.048
71130656|NCT01371734|141765073|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.708||||0.21|TWO_SIDED|95.0|0.412|1.216|||Regression, Logistic|||Week 4||1.216|0.412|0.210
71130657|NCT01371734|141765073|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.964||||0.893|TWO_SIDED|95.0|0.564|1.646|||Regression, Logistic|||Week 4||1.646|0.564|0.893
71130658|NCT01371734|141765073|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.714||||0.228|TWO_SIDED|95.0|0.413|1.235|||Regression, Logistic|||Week 6||1.235|0.413|0.228
71130659|NCT01371734|141765073|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.916||||0.751|TWO_SIDED|95.0|0.531|1.579|||Regression, Logistic|||Week 6||1.579|0.531|0.751
71130660|NCT01371734|141765073|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.974||||0.925|TWO_SIDED|95.0|0.561|1.689|||Regression, Logistic|||Week 8||1.689|0.561|0.925
71130661|NCT01371734|141765073|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.764||||0.342|TWO_SIDED|95.0|0.438|1.331|||Regression, Logistic|||Week 8||1.331|0.438|0.342
71130662|NCT01736618|141765106|OTHER||Kaplan-Meier|92.9|||||ONE_SIDED|95.0|91.4|||||||"Ho: The Type I Complication Free Rate at 60 months (p1) does not exceed the performance goal of 85.0%.~Ho: p1 ≤ 85.0% Ha: The Type I Complication Free Rate at 60 months (p1) does exceed the performance goal of 85.0%.~Ha: p1 \> 85.0% The null hypothesis will be rejected if the lower one-sided 95% confidence bound of the proportional means model estimate, using the Peto method for standard error, exceeds the performance goal of 85.0%."|||91.4|
71130663|NCT01736618|141765107|OTHER||Clopper-Pearson exact confidence bound|98.6|||||ONE_SIDED|95.0|97.4|||||||"Ho: Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of VT/VF through 60 months (p1) does not exceed the performance goal of 94.0%.~Ho: p1 ≤ 94.0% Ha: Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of VT/VF through 60 months (p1) does exceed the performance goal of 94.0%.~Ha: p1 \>94.0% The null hypothesis will be rejected if the lower one-sided 95% exact confidence bound of the estimate exceeds the performance goal of 94.0%."|||97.4|
71130664|NCT01736618|141765108|OTHER||Kaplan-Meier|99.2|||||ONE_SIDED|95.0|98.8|||||||"Ho: The Electrode-Related Complication Free Rate at 60 months (p1) does not exceed the performance goal of 92.5%.~Ho: p1 ≤ 92.5% Ha: The Electrode-Related Complication Free Rate at 60 months (p1) does exceed the performance goal of 92.5%.~Ha: p1 \> 92.5% The null hypothesis will be rejected if the lower one-sided 95% confidence bound of the proportional means model estimate, using the Peto method for standard error, exceeds the performance goal of 92.5%."|||98.8|
71130665|NCT01736618|141765109|OTHER||Clopper-Pearson exact confidence bound|94.4|||||ONE_SIDED|95.0|93.5|||||||"Ho: The 1st Shock Effectiveness in Converting Induced (Acute) \& Spontaneous Discrete VT/VF Episodes to 60 months (p1) does not exceed the performance goal of 84.0%.~Ho: p1 ≤ 84.0% Ha: The 1st Shock Effectiveness in Converting Induced (Acute) \& Spontaneous Discrete VT/VF Episodes to 60 months (p1) does exceed the performance goal of 84.0%.~Ha: p1 \>84.0% The null hypothesis will be rejected if lower one-sided 95% exact confidence bound of the estimate exceeds the performance goal of 84.0%."|||93.5|
71130666|NCT03637517|141765118|EQUIVALENCE|2 comparisons performed: Reg. B vs. Reg. A, \& Reg.C vs. Reg. B. Bioavailability of each test reg. relative to that of each reference reg. assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model. Bioequivalence between a test reg. and the reference reg. is concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within 0.80 to 1.25 range.|Least Squares Means Log scale|0.926||||0.4847|TWO_SIDED|90.0|0.771|1.113|||ANOVA|||||1.113|0.771|0.4847
71130667|NCT03637517|141765118|EQUIVALENCE|2 comparisons performed: Reg. B vs. Reg. A, \& Reg.C vs. Reg. B. Bioavailability of each test reg. relative to that of each reference reg. assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model. Bioequivalence between a test reg. and the reference reg. is concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within 0.80 to 1.25 range.|Least Squares Means Log scale|0.79||||0.037|TWO_SIDED|90.0|0.658|0.95|||ANOVA|||||0.950|0.658|0.0370
71130668|NCT03637517|141765119|EQUIVALENCE|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper \& lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|0.899||||0.1135|TWO_SIDED|90.0|0.805|1.004|||ANOVA|||||1.004|0.805|0.1135
71130669|NCT03637517|141765119|EQUIVALENCE|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper \& lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|1.175||||0.0192|TWO_SIDED|90.0|1.051|1.312|||ANOVA|||||1.312|1.051|0.0192
71130670|NCT03637517|141765120|EQUIVALENCE|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper \& lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|0.898||||0.1759|TWO_SIDED|90.0|0.787|1.024|||ANOVA||Regimen B to A|||1.024|0.787|0.1759
71130671|NCT03637517|141765120|EQUIVALENCE|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper \& lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|1.172||||0.0496|TWO_SIDED|90.0|1.027|1.338|||ANOVA||Regimen C to B|||1.338|1.027|0.0496
71130672|NCT03637517|141765121|EQUIVALENCE|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper \& lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Least Squares Means|-0.2857|STANDARD_ERROR_OF_MEAN|1.866979|||TWO_SIDED|90.0|-3.4313|2.8599||||||||2.8599|-3.4313|
71130673|NCT03637517|141765121|EQUIVALENCE|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper \& lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Least Squares Means|9.3571|STANDARD_ERROR_OF_MEAN|1.866979|||TWO_SIDED|90.0|6.2115|12.5028|||||Regimen C to B|||12.5028|6.2115|
71130674|NCT03637517|141765123|EQUIVALENCE|Bioequivalence between a test regimen and the respective reference regimen will be concluded if the 90% confidence intervals from the analyses of the natural logarithms of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|0.866||||0.1745|TWO_SIDED|90.0|0.727|1.032|||ANOVA|||(ANOVA) will be performed for Tmax, the terminal phase elimination rate constant β, and the natural logarithms of Cmax, AUCt, AUC168, AUCinf, and C168. The model will include the effects for regimen. For the tests on regimen effects, the denominator sum of squares will be the residual sum of squares for error. Within the ANOVA modeling framework, the test regimen will be compared to the respective reference regimen by a test with a significance level of 0.05.||1.032|0.727|0.1745
70859715|NCT02278341|141205905|SUPERIORITY||Hazard Ratio (HR)|1.154|||=|0.164|TWO_SIDED|95.0|0.943|1.411||p-value for superiority test based on 2-sided significance level|Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on region, CV history, previous ESA treatment and adjusting on Hb at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.411|0.943|=0.164
70859716|NCT02278341|141205906|SUPERIORITY||Hazard Ratio (HR)|0.979|||=|0.917|TWO_SIDED|95.0|0.656|1.462|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on region, CV history, previous ESA treatment and adjusting on Hb at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.462|0.656|=0.917
71130675|NCT03637517|141765123|EQUIVALENCE|Bioequivalence between a test regimen and the respective reference regimen will be concluded if the 90% confidence intervals from the analyses of the natural logarithms of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|1.185||||0.1105|TWO_SIDED|90.0|0.995|1.411||For tests on regimen effects, the denominator sum of squares is the residual sum of squares for error. Within the ANOVA modeling framework, the test regimen is compared to the respective reference regimen by a test with a significance level of 0.05.|ANOVA|||||1.411|0.995|0.1105
71130676|NCT03637517|141765124|EQUIVALENCE|Bioequivalence between a test regimen and the respective reference regimen will be concluded if the 90% confidence intervals from the analyses of the natural logarithms of Cmax and AUC are within the 0.80 to 1.25 range.|LEAST SQUARES MEANS FOR LOGARITHMS.|0.901||||0.31|TWO_SIDED|90.0|0.759|1.069|||ANOVA|||||1.069|0.759|0.3100
71130677|NCT03637517|141765124|EQUIVALENCE|Bioequivalence between a test regimen and the respective reference regimen will be concluded if the 90% confidence intervals from the analyses of the natural logarithms of Cmax and AUC are within the 0.80 to 1.25 range.|LEAST SQUARES MEANS FOR LOGARITHMS.|1.156||||0.1619|TWO_SIDED|90.0|0.974|1.371|||ANOVA|||||1.371|0.974|0.1619
71130678|NCT02714283|141765129|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.19|TWO_SIDED|95.0|0.51|1.14|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use.|ICS (numerator) compared to macrolide monotherapy (denominator)|Due to the small sample size in the macrolide monotherapy group, for this outcome, the results are considered exploratory/descriptive only.||1.14|0.51|0.19
71130679|NCT02714283|141765130|SUPERIORITY||Hazard Ratio (HR)|1.39|||<|0.0001|TWO_SIDED|95.0|1.23|1.57|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history.|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.57|1.23|<0.0001
71130680|NCT02714283|141765131|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.21|TWO_SIDED|95.0|0.67|1.09|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history.|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.09|0.67|0.21
71130681|NCT02714283|141765132|SUPERIORITY||Hazard Ratio (HR)|0.73|||<|0.0001|TWO_SIDED|95.0|0.64|0.82|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history|ICS (numerator) compared to macrolide monotherapy (denominator)|||0.82|0.64|<0.0001
70859717|NCT02278341|141205907|SUPERIORITY||Hazard Ratio (HR)|0.867|||=|0.501|TWO_SIDED|95.0|0.573|1.313||p-value for superiority test based on 2-sided significance level|Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on region, CV history, previous ESA treatment, and adjusting on Hb at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.313|0.573|=0.501
70859718|NCT02278341|141205908|SUPERIORITY||LSM Difference|-0.006|||=|0.507|TWO_SIDED|95.0|-0.02|0.01||p-value for superiority test based on 2-sided significance level|ANCOVA|||The model included treatment arm, region, CV History, previous ESA treatment as categorical variables and baseline Hb as continuous variable.||0.01|-0.02|=0.507
70859719|NCT02278341|141205909|SUPERIORITY||LSM Difference|0.132|||=|0.949|TWO_SIDED|95.0|-3.9|4.16|||ANCOVA|||The model included treatment arm, region, CV History, previous ESA treatment as categorical variables and baseline Hb as continuous variable.||4.16|-3.90|=0.949
70859720|NCT02278341|141205910|SUPERIORITY||Hazard Ratio (HR)|0.368|||<|0.001|TWO_SIDED|95.0|0.291|0.465|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on region, CV history, previous ESA treatment and adjusting on Hb at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI was below 1.0.||0.465|0.291|<0.001
70859721|NCT02278341|141205911|SUPERIORITY||LSM Difference|-35.1|||<|0.001|TWO_SIDED|95.0|-51.8|-18.4|||ANCOVA|||Weeks 37-52 - Participants with no or missing medication records of IV Iron had their monthly IV Iron use set to 0 mg. The model includes treatment arm, region, CV History, previous ESA treatment as categorical variables and baseline Hb as continuous variable.||-18.4|-51.8|<0.001
70859722|NCT02278341|141205911|SUPERIORITY||LSM Difference|-48.7|||<|0.001|TWO_SIDED|95.0|-70.3|-27.0|||ANCOVA|||Weeks 53-104 - Participants with no or missing medication records of IV Iron had their monthly IV Iron use set to 0 mg. The model includes treatment arm, region, CV History, previous ESA treatment as categorical variables and baseline Hb as continuous variable.||-27.0|-70.3|<0.001
70859723|NCT02278341|141205921|SUPERIORITY||LSM Difference|0.521|||=|0.161|TWO_SIDED|95.0|-0.208|1.25||p-value for superiority test based on 2-sided significance level|Mixed Models Analysis|||The model includes treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline SF-36 PCS, baseline Hb, as continuous covariates.||1.250|-0.208|=0.161
70859724|NCT02278341|141205922|SUPERIORITY||LSM Difference|0.126|||=|0.845|TWO_SIDED|95.0|-1.135|1.387||p-value for superiority test based on 2-sided significance level|Mixed Models Analysis|||The model includes treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline FACT-An Ans, baseline Hb, as continuous covariates.||1.387|-1.135|=0.845
70859725|NCT02278341|141205923|SUPERIORITY||LSM Difference|-0.128|||=|0.922|TWO_SIDED|95.0|-2.703|2.447||p-value for superiority test based on 2-sided significance level|Mixed Models Analysis|||The model includes treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline FACT-An Ans, baseline Hb, as continuous covariates.||2.447|-2.703|=0.922
70859726|NCT02604017|141205931|NON_INFERIORITY|The noninferiority of the rate of SVR12 for the 12-week treatment group as compared with the historical rate was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with SVR12 must exceed 91% to achieve noninferiority.|Percentage of Participants|99.7|||||TWO_SIDED|95.0|99.1|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of ≥97% in the 12-week arm, 270 participants provides \>90% power to demonstrate noninferiority of the 12-week arm to the historical control rate for HCV GT1 subjects who are treatment-naïve or treated with pegIFN/RBV (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|99.1|
70859727|NCT02604017|141205932|NON_INFERIORITY|The noninferiority of the rate of SVR12 for the 8-week treatment group as compared with the 12-week treatment group was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the difference in percentage of participants with SVR12 (8-week group minus 12-week group) must be above -5% to achieve noninferiority.|Difference in Percentage of Participants|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Based on a 2-sided significance level of 0.05 and an -5% noninferiority margin and an underlying rate of ≥97% in the 8-week arm (270 participants) and ≥97% in the 12-week arm (270 participants) provides \>90% power to demonstrate noninferiority of the 8-week arm to the 12-week arm.||1.1|-1.1|
70859728|NCT02604017|141205933|NON_INFERIORITY|The noninferiority of the rate of SVR12 for the 8-week treatment group as compared with the 12-week treatment group was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the difference in percentage of participants with SVR12 must be above -5% to achieve noninferiority.|Difference in Percentage of Participants|-0.6|||||TWO_SIDED|95.0|-1.8|0.6||||||Based on a 2-sided significance level of 0.05 and a -5% noninferiority margin, and an underlying rate of ≥97% in the 8-week arm (270 participants) and ≥97% in the 12-week arm (270 participants) provides \>90% power to demonstrate noninferiority of the 8-week arm to the 12-week arm.||0.6|-1.8|
70859729|NCT02011893|141205967|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 7.5 points, where the Visual Analog Scale (VAS) scores were measured on a scale of 0 to 100. Testing was carried out at a 5% significance level.|||||<|0.001|||||||t-distribution|95% UCB and p-value for non-inferiority are based on t-distribution with n1 + n2-2 degrees of freedom where n1 and n2 are number of subjects per arm.||||||<0.001
70859730|NCT02011893|141205968|SUPERIORITY_OR_OTHER|||||||0.083||||||Superiority analysis performed|McNemar|||||||0.083
70859731|NCT02011893|141205970|SUPERIORITY_OR_OTHER|||||||0.017||||||Superiority analysis performed|t-distribution|95% UCB and p-value for superiority are based on t-distribution with n1 + n2-2 degrees of freedom where n1 and n2 are number of subjects per arm.||||||0.017
70859732|NCT03977454|141205971|SUPERIORITY||Mean Difference (Net)|1.2||||0.69|TWO_SIDED||||||t-test, 2 sided|||The primary endpoint was a comparison between groups at 24 hours.||||0.69
70859733|NCT03977454|141205972|SUPERIORITY||Mean Difference (Net)|0.1||||0.92|TWO_SIDED||||||t-test, 2 sided|||Scores were compared at 2 days post operation.||||0.92
70859734|NCT03977454|141205973|SUPERIORITY||Mean Difference (Net)|0.5||||0.91|TWO_SIDED||||||t-test, 2 sided|||||||0.91
70859735|NCT03977454|141205975|SUPERIORITY||Mean Difference (Net)|0.0||||0.85|TWO_SIDED||||||t-test, 2 sided|||Scores were compared at 2 weeks.||||0.85
70859736|NCT01289782|141205976|SUPERIORITY_OR_OTHER||Difference in proportions of SVR12|29.3|||<|0.001|TWO_SIDED|95.0|20.1|38.6|||Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference in proportions of SVR12 between the treatment groups.||38.6|20.1|<0.001
70859737|NCT01289782|141205977|SUPERIORITY_OR_OTHER||Difference in proportions of SVRW72|28.9|||<|0.001|TWO_SIDED|95.0|19.6|38.2|||Cochran-Mantel-Haenszel|||There is no difference in proportions of SVRW72 between the treatment groups.||38.2|19.6|<0.001
70859738|NCT01289782|141205978|SUPERIORITY_OR_OTHER||Difference in proportions of SVR24|30.1|||<|0.001|TWO_SIDED|95.0|20.8|39.3|||Cochran-Mantel-Haenszel|||There is no difference in proportions of SVR24 between the treatment groups.||39.3|20.8|<0.001
70859739|NCT01289782|141205979|SUPERIORITY_OR_OTHER||Difference in proportions of SVR4|25.8|||<|0.001|TWO_SIDED|95.0|16.8|34.8|||Cochran-Mantel-Haenszel|||There is no difference in proportions of SVR4 between the treatment groups.||34.8|16.8|<0.001
70859740|NCT01289782|141206006|SUPERIORITY_OR_OTHER||Mean differences|-20.679|STANDARD_ERROR_OF_MEAN|6.0979|<|0.001|TWO_SIDED|95.0|-32.6399|-8.7181|||Piecewise-Linear Model Approach|||Fatigue Severity Score AUC60||-8.7181|-32.6399|<0.001
70859741|NCT01289782|141206006|SUPERIORITY_OR_OTHER||Mean differences|-23.8|STANDARD_ERROR_OF_MEAN|7.2358|<|0.001|TWO_SIDED|95.0|-37.9931|-9.6064|||Piecewise Linear Model|||Fatigue Severity Score AUC72||-9.6064|-37.9931|<0.001
70859742|NCT01289782|141206007|SUPERIORITY_OR_OTHER||Mean differences|-230.464|STANDARD_ERROR_OF_MEAN|105.9203||0.03|TWO_SIDED|95.0|-438.2662|-22.6626|||Piecewise Linear Model|||Impairment in Work Productivity AUC60||-22.6626|-438.2662|0.030
70859743|NCT01289782|141206007|SUPERIORITY_OR_OTHER||Mean differences|-248.208|STANDARD_ERROR_OF_MEAN|124.6753||0.047|TWO_SIDED|95.0|-492.8253|-3.5916|||Piecewise Linear Model|||Impairment in Work Productivity AUC72||-3.5916|-492.8253|0.047
70859744|NCT01289782|141206008|SUPERIORITY_OR_OTHER||Mean Differences|-278.06|STANDARD_ERROR_OF_MEAN|105.6088||0.009|TWO_SIDED|95.0|-485.2529|-70.8668|||Piecewise linear model|||Impairment in Daily Activities AUC60||-70.8668|-485.2529|0.009
70859745|NCT01289782|141206008|SUPERIORITY_OR_OTHER||Mean differences|-307.722|STANDARD_ERROR_OF_MEAN|124.1956||0.013|TWO_SIDED|95.0|-551.4006|-64.0429|||Piecewise Linear Model|||Impairment in Daily Activities AUC72||-64.0429|-551.4006|0.013
70859746|NCT01289782|141206009|SUPERIORITY_OR_OTHER||Mean differences|46.399|STANDARD_ERROR_OF_MEAN|99.7966||0.642|TWO_SIDED|95.0|-149.6374|242.436|||Piecewise linear model|||Time Missed from Work AUC60||242.4360|-149.6374|0.642
70859747|NCT01289782|141206009|SUPERIORITY_OR_OTHER||Mean differences|57.164|STANDARD_ERROR_OF_MEAN|115.1548||0.62|TWO_SIDED|95.0|-169.1143|283.4414|||Piecewise Linear Model|||Time Missed from Work AUC72||283.4414|-169.1143|0.620
70859748|NCT00518973|141206025|SUPERIORITY|||||||0.15||||||t = 2.8|t-test, 2 sided|Hours occupied by preoccupations.||||||.15
70859749|NCT00518973|141206025|SUPERIORITY|||||||0.4||||||t = .56|t-test, 2 sided|Hours of rituals||||||.40
70859750|NCT00518973|141206026|SUPERIORITY|||||||0.72||||||t = .13|t-test, 2 sided|||||||.72
70859751|NCT00518973|141206027|SUPERIORITY|||||||0.48||||||t = .52|t-test, 2 sided|Reporting for Trait||||||.48
70859752|NCT00518973|141206027|SUPERIORITY|||||||0.77||||||t = .09|t-test, 2 sided|Reporting for State||||||.77
70859753|NCT00518973|141206028|SUPERIORITY|||||||0.83||||||t = .05|t-test, 2 sided|||||||.83
70859754|NCT00518973|141206029|SUPERIORITY|||||||0.4||||||t = .78|t-test, 2 sided|Positive Scale||||||.40
70859755|NCT00518973|141206029|SUPERIORITY|||||||0.11||||||t=3.0|t-test, 2 sided|Negative Scale||||||.11
70859756|NCT00518973|141206029|SUPERIORITY|||||||0.9||||||t = .02|t-test, 2 sided|General Scale||||||.90
70859757|NCT03239665|141206030|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0081||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing total knowledge score change between groups from baseline to post intervention||||0.0081
70859758|NCT03239665|141206030|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0243||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing zoster knowledge score change between groups from baseline to post intervention||||0.0243
70859759|NCT03239665|141206030|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.071||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing pneumonia knowledge score change between groups from baseline to post intervention||||0.0710
70859760|NCT03239665|141206030|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0008||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing influenza knowledge score change between groups from baseline to post intervention||||0.0008
70859761|NCT03239665|141206030|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.1094||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing total knowledge score change between groups from baseline to one-month follow-up||||0.1094
70859762|NCT03239665|141206030|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.2029||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing zoster knowledge score change between groups from baseline to one-month follow-up||||0.2029
70859763|NCT03239665|141206030|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.8599||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing pneumonia knowledge score change between groups from baseline to one-month follow-up||||0.8599
70859764|NCT03239665|141206030|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0007||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing influenza knowledge score change between groups from baseline to one-month follow-up||||0.0007
71130682|NCT02714283|141765133|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.87|TWO_SIDED|95.0|0.8|1.32|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.32|0.80|0.87
70859765|NCT03239665|141206030|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0246||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing total knowledge score change between groups from post-intervention to one-month follow-up||||0.0246
70859766|NCT03239665|141206030|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.078||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing zoster knowledge score change between groups from post-intervention to one-month follow-up||||0.0780
70859767|NCT03239665|141206030|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0167||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing pneumonia knowledge score change between groups from post-intervention to one-month follow-up||||0.0167
70859768|NCT03239665|141206030|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.9417||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing influenza knowledge score change between groups from post-intervention to one-month follow-up||||0.9417
70859769|NCT03239665|141206031|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0011||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations is important to my health from baseline to post-intervention"||||0.0011
70859770|NCT03239665|141206031|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|||||<|0.0001||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations is important to my health from baseline to post-intervention"||||<0.0001
70859771|NCT03239665|141206031|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0028||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations is important to my health from baseline to one-month follow-up"||||0.0028
70859772|NCT03239665|141206031|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|||||<|0.0001||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations is important to my health from baseline to one-month follow-up"||||<0.0001
70859773|NCT03239665|141206031|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||1||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations is important to my health from post-intervention to one-month follow-up"||||1.0
70859774|NCT03239665|141206031|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.643||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations is important to my health from post-intervention to one-month follow-up"||||0.6430
70859775|NCT03239665|141206031|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.1193||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations can be harmful to my health from baseline to post-intervention"||||0.1193
70859776|NCT03239665|141206031|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|||||<|0.0001||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations can be harmful to my health from baseline to post-intervention"||||<0.0001
70859777|NCT03239665|141206031|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.4861||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations can be harmful to my health from baseline to one-month follow-up"||||0.4861
70859778|NCT03239665|141206031|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0002||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations can be harmful to my health from baseline to one-month follow-up"||||0.0002
70859779|NCT03239665|141206031|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.3247||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations can be harmful to my health from post-intervention to one-month follow-up"||||0.3247
70859780|NCT03239665|141206031|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.4627||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations can be harmful to my health from post-intervention to one-month follow-up"||||0.4627
70859781|NCT03239665|141206031|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.1244||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my doctor to give me information about vaccines and the diseases they prevent from baseline to post-intervention"||||0.1244
71130683|NCT02714283|141765134|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.23|TWO_SIDED|95.0|0.76|1.07|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history.|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.07|0.76|0.23
71130684|NCT02714283|141765135|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.2|TWO_SIDED|95.0|0.96|1.25|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history.|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.25|0.96|0.20
71130685|NCT02714283|141765136|SUPERIORITY||Hazard Ratio (HR)|1.15|||<|0.0001|TWO_SIDED|95.0|1.08|1.21|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.21|1.08|<0.0001
71130686|NCT02714283|141765137|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.99|TWO_SIDED|95.0|0.66|1.51|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.51|0.66|0.99
71130687|NCT02714283|141765138|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.0005|TWO_SIDED|95.0|1.07|1.25|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.25|1.07|0.0005
71130688|NCT00620113|141765139|SUPERIORITY_OR_OTHER||Difference in LS Means|5.4|||<|0.001|TWO_SIDED|95.0|4.16|6.64||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an analysis of covariance (ANCOVA) model with terms for treatment and study center. Treatment effect was assessed by Least-Squares means (LS mean) and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||6.64|4.16|<0.001
71130689|NCT00620113|141765139|SUPERIORITY_OR_OTHER||Difference in LS Means|5.12|||<|0.001|TWO_SIDED|95.0|3.9|6.35||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||6.35|3.90|<0.001
70859782|NCT03239665|141206031|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0575||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my doctor to give me information about vaccines and the diseases they prevent from baseline to post-intervention"||||0.0575
71130690|NCT00620113|141765139|SUPERIORITY_OR_OTHER||Difference in LS Means|3.54|||<|0.001|TWO_SIDED|95.0|2.33|4.75||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||4.75|2.33|<0.001
71130691|NCT00620113|141765140|SUPERIORITY_OR_OTHER||Difference in LS Means|3.06|||<|0.001|TWO_SIDED|95.0|2.14|3.98||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||3.98|2.14|<0.001
71130692|NCT00620113|141765140|SUPERIORITY_OR_OTHER||Difference in LS Means|2.2|||<|0.001|TWO_SIDED|95.0|1.29|3.12||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||3.12|1.29|<0.001
71130693|NCT00620113|141765140|SUPERIORITY_OR_OTHER||Difference in LS Means|1.67|||<|0.001|TWO_SIDED|95.0|0.77|2.57||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||2.57|0.77|<0.001
71130694|NCT00620113|141765143|SUPERIORITY_OR_OTHER||Difference in LS Means|3.08|||<|0.001|TWO_SIDED|95.0|1.85|4.31||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||4.31|1.85|<0.001
70859783|NCT03239665|141206031|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.7489||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my doctor to give me information about vaccines and the diseases they prevent from baseline to one-month follow-up"||||0.7489
70859784|NCT03239665|141206031|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0098||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my doctor to give me information about vaccines and the diseases they prevent from baseline to one-month follow-up"||||0.0098
70859785|NCT03239665|141206031|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.1797||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my doctor to give me information about vaccines and the diseases they prevent from post-intervention to one-month follow-up"||||0.1797
70859786|NCT03239665|141206031|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.3613||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my doctor to give me information about vaccines and the diseases they prevent from post-intervention to one-month follow-up"||||0.3613
70859787|NCT03239665|141206031|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.5972||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my pharmacist to give me information about vaccines and the diseases they prevent from baseline to post-intervention"||||0.5972
70859788|NCT03239665|141206031|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.024||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my pharmacist to give me information about vaccines and the diseases they prevent from baseline to post-intervention"||||0.0240
70859789|NCT03239665|141206031|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.2437||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my pharmacist to give me information about vaccines and the diseases they prevent from baseline to one-month follow-up"||||0.2437
70859790|NCT03239665|141206031|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0631||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my pharmacist to give me information about vaccines and the diseases they prevent from baseline to one-month follow-up"||||0.0631
70859791|NCT03239665|141206031|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.054||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my pharmacist to give me information about vaccines and the diseases they prevent from post-intervention to one-month follow-up"||||0.0540
70859792|NCT03239665|141206031|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.7298||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my pharmacist to give me information about vaccines and the diseases they prevent from post-intervention to one-month follow-up"||||0.7298
70859793|NCT03239665|141206031|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.4218||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust a peer educator to give me information about vaccines and the diseases they prevent from baseline to post-intervention"||||0.4218
70859794|NCT03239665|141206031|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.2282||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust a peer educator to give me information about vaccines and the diseases they prevent from baseline to post-intervention"||||0.2282
70859795|NCT03239665|141206031|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.8711||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust a peer educator to give me information about vaccines and the diseases they prevent from baseline to one-month follow-up"||||0.8711
70859796|NCT03239665|141206031|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0027||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust a peer educator to give me information about vaccines and the diseases they prevent from baseline to one-month follow-up"||||0.0027
70859797|NCT03239665|141206031|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.7579||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust a peer educator to give me information about vaccines and the diseases they prevent from post-intervention to one-month follow-up"||||0.7579
70859798|NCT03239665|141206031|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.1299||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust a peer educator to give me information about vaccines and the diseases they prevent from post-intervention to one-month follow-up"||||0.1299
70859799|NCT03239665|141206033|EQUIVALENCE|Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.||||||1||||||Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.|Fisher Exact|||Testing between-group differences in dichotomous engagement in the program immediately post-intervention via Fisher's Exact test||||1.0
70859800|NCT03239665|141206033|EQUIVALENCE|Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.||||||0.6806||||||Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.|Fisher Exact|||Testing between-group differences in dichotomous engagement in the program at the one-month follow-up via Fisher's Exact test||||0.6806
70859801|NCT03239665|141206033|EQUIVALENCE|Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.||||||1||||||Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.|Fisher Exact|||Testing between-group differences in dichotomous satisfaction with the program's content immediately post-intervention via Fisher's Exact test||||1.0
70859802|NCT03239665|141206033|EQUIVALENCE|Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.||||||0.4908||||||Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.|Fisher Exact|||Testing between-group differences in dichotomous satisfaction with the program's content at the one-month follow-up via Fisher's Exact test||||0.4908
70859803|NCT03239665|141206034|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.7728|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive zoster vaccine at baseline via Chi-squared test||||0.7728
70859804|NCT03239665|141206034|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.6871|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive zoster vaccine post-intervention via Chi-squared test||||0.6871
70859805|NCT03239665|141206034|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.8259|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive zoster vaccine at one-month follow-up via Chi-squared test||||0.8259
70859806|NCT03239665|141206034|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.8868|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive influenza vaccine at baseline via Chi-squared test||||0.8868
70859807|NCT03239665|141206034|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.8069|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive influenza vaccine post-intervention via Chi-squared test||||0.8069
70859808|NCT03239665|141206034|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.8489|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive influenza vaccine at one-month follow-up via Chi-squared test||||0.8489
70954363|NCT03568318|141411393|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|38.1|||<|0.001|TWO_SIDED|95.0|30.8|45.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||45.4|30.8|<0.001
70859809|NCT03239665|141206034|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.3985|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive pneumonia vaccine at baseline via Chi-squared test||||0.3985
70859810|NCT03239665|141206034|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.1722|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive pneumonia vaccine post-intervention via Chi-squared test||||0.1722
70859811|NCT03239665|141206034|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.7318|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive pneumonia vaccine at one-month follow-up via Chi-squared test||||0.7318
70859812|NCT03239665|141206034|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.6309|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants planning to receive zoster vaccine post-intervention via Chi-squared test||||0.6309
70859813|NCT03239665|141206034|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.7881|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants planning to receive zoster vaccine at one-month follow-up via Chi-squared test||||0.7881
70859814|NCT03239665|141206034|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.6798|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants planning to receive influenza vaccine post-intervention via Chi-squared test||||0.6798
70859815|NCT03239665|141206034|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.8548|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants planning to receive influenza vaccine at one-month follow-up via Chi-squared test||||0.8548
70859816|NCT03239665|141206034|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.3182|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants planning to receive pneumonia vaccine post-intervention via Chi-squared test||||0.3182
70859817|NCT03239665|141206034|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.7986|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants planning to receive pneumonia vaccine at one-month follow-up via Chi-squared test||||0.7986
70954364|NCT03568318|141411394|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|47.6|||<|0.001|TWO_SIDED|95.0|41.1|54.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response rate difference = Upadacitinib - Placebo|||54.0|41.1|<0.001
71130695|NCT00620113|141765143|SUPERIORITY_OR_OTHER||Difference in LS Means|1.86||||0.003|TWO_SIDED|95.0|0.64|3.08||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||3.08|0.64|0.003
71130696|NCT00620113|141765143|SUPERIORITY_OR_OTHER||Difference in LS Means|2.23|||<|0.001|TWO_SIDED|95.0|1.03|3.43||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||3.43|1.03|<0.001
71130697|NCT00620113|141765144|SUPERIORITY_OR_OTHER||Difference in LS Means|4.66|||<|0.001|TWO_SIDED|95.0|3.18|6.14||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||6.14|3.18|<0.001
70859818|NCT03239665|141206035|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0163|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of zoster vaccine at baseline via Chi-squared test||||0.0163
70859819|NCT03239665|141206035|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0028|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of zoster vaccine post-intervention via Chi-squared test||||0.0028
70859820|NCT03239665|141206035|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0433|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of zoster vaccine at one-month follow-up via Chi-squared test||||0.0433
70859821|NCT03239665|141206035|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0592|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of influenza vaccine at baseline via Chi-squared test||||0.0592
70859822|NCT03239665|141206035|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.1843|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of influenza vaccine post-intervention via Chi-squared test||||0.1843
70859823|NCT03239665|141206035|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.5933|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of influenza vaccine at one-month follow-up via Chi-squared test||||0.5933
70859824|NCT03239665|141206035|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.3942|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of pneumonia vaccine at baseline via Chi-squared test||||0.3942
70859825|NCT03239665|141206035|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.9062|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of pneumonia vaccine post-intervention via Chi-squared test||||0.9062
70859826|NCT03239665|141206035|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.9618|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of pneumonia vaccine at one-month follow-up via Chi-squared test||||0.9618
70954365|NCT03568318|141411394|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|28.5|||<|0.001|TWO_SIDED|95.0|22.1|34.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response rate difference = Upadacitinib - Placebo|||34.9|22.1|<0.001
70859827|NCT03239665|141206035|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.114|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants reporting positive history of zoster vaccine at one-month follow-up via Chi-squared test||||0.1140
70859828|NCT03239665|141206035|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0141|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants reporting positive history of influenza vaccine at one-month follow-up via Chi-squared test||||0.0141
70859829|NCT03239665|141206035|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0457|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants reporting positive history of pneumonia vaccine at one-month follow-up via Chi-squared test||||0.0457
70859830|NCT03239665|141206036|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.6153|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their doctor at baseline via Chi-squared test||||0.6153
70859831|NCT03239665|141206036|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.8299|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their doctor post-intervention via Chi-squared test||||0.8299
70859832|NCT03239665|141206036|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0405|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their doctor at one-month follow-up via Chi-squared test||||0.0405
70859833|NCT03239665|141206036|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.3776|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their pharmacist at baseline via Chi-squared test||||0.3776
70859834|NCT03239665|141206036|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.2856|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their pharmacist post-intervention via Chi-squared test||||0.2856
70859835|NCT03239665|141206036|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0016|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their pharmacist at one-month follow-up via Chi-squared test||||0.0016
70859836|NCT03239665|141206036|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.9449|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their family/friends at baseline via Chi-squared test||||0.9449
70859837|NCT03239665|141206036|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.6143|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their family/friends post-intervention via Chi-squared test||||0.6143
70859838|NCT03239665|141206036|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0036|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their family/friends at one-month follow-up via Chi-squared test||||0.0036
70859839|NCT03239665|141206037|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.|||||<|0.0001|||||||Chi-squared|||Testing between-group differences in number of participants having discussed vaccines with their doctor at one-month follow-up via Chi-squared test||||<0.0001
71130698|NCT00620113|141765144|SUPERIORITY_OR_OTHER||Difference in LS Means|3.84|||<|0.001|TWO_SIDED|95.0|2.37|5.3||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||5.30|2.37|<0.001
71130699|NCT00620113|141765144|SUPERIORITY_OR_OTHER||Difference in LS Means|2.43||||0.002|TWO_SIDED|95.0|0.99|3.88||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||3.88|0.99|0.002
71130700|NCT00620113|141765145|SUPERIORITY_OR_OTHER||Difference in LS Means|-50.64|||<|0.001|TWO_SIDED|95.0|-66.43|-34.84||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-34.84|-66.43|<0.001
71130701|NCT00620113|141765145|SUPERIORITY_OR_OTHER||Difference in LS Means|-44.32|||<|0.001|TWO_SIDED|95.0|-60.42|-28.21||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-28.21|-60.42|<0.001
71130702|NCT00620113|141765145|SUPERIORITY_OR_OTHER||Difference in LS Means|-35.75|||<|0.001|TWO_SIDED|95.0|-52.33|-19.16||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-19.16|-52.33|<0.001
71130703|NCT00620113|141765146|SUPERIORITY_OR_OTHER||Difference in LS Means|-60.42|||<|0.001|TWO_SIDED|95.0|-85.7|-35.13||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-35.13|-85.70|<0.001
71130704|NCT00620113|141765146|SUPERIORITY_OR_OTHER||Difference in LS Means|-60.7|||<|0.001|TWO_SIDED|95.0|-85.91|-35.49||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-35.49|-85.91|<0.001
71130705|NCT00620113|141765146|SUPERIORITY_OR_OTHER||Difference in LS Means|-38.73|||<|0.001|TWO_SIDED|95.0|-65.94|-11.52||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-11.52|-65.94|<0.001
71130706|NCT00620113|141765147|SUPERIORITY_OR_OTHER||Difference in LS Means|-42.91|||<|0.001|TWO_SIDED|95.0|-65.55|-20.27||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-20.27|-65.55|<0.001
70859840|NCT03239665|141206037|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0012|||||||Chi-squared|||Testing between-group differences in number of participants having discussed vaccines with their pharmacist at one-month follow-up via Chi-squared test||||0.0012
70859841|NCT03239665|141206037|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0034|||||||Chi-squared|||Testing between-group differences in number of participants having discussed vaccines with their family/friends at one-month follow-up via Chi-squared test||||0.0034
70859842|NCT01754909|141206059|SUPERIORITY|Occurrence rates, comparison by t test||||||0.05|||||||t-test, 2 sided|||||||0.05
70859843|NCT03519386|141206103|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs. Timolol|Mean Difference (Final Values)|-0.79|||||TWO_SIDED|95.0|-1.45|-0.13||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Day 10, 8AM Difference between Implant Group 2 and timolol||-0.13|-1.45|
71130707|NCT00620113|141765147|SUPERIORITY_OR_OTHER||Difference in LS Means|-37.45||||0.001|TWO_SIDED|95.0|-60.32|-14.59||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-14.59|-60.32|0.001
71130708|NCT00620113|141765147|SUPERIORITY_OR_OTHER||Difference in LS Means|-26.77||||0.017|TWO_SIDED|95.0|-50.37|-3.16||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-3.16|-50.37|0.017
71130709|NCT00620113|141765148|SUPERIORITY_OR_OTHER||Difference in LS Means|-15.52|||<|0.001|TWO_SIDED|95.0|-25.11|-5.93||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-5.93|-25.11|<0.001
70859844|NCT03519386|141206103|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-1.24|||||TWO_SIDED|95.0|-1.92|-0.56||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Day 10, 10AM Difference between Implant Group 2 and timolol||-0.56|-1.92|
70859845|NCT03519386|141206103|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-0.18|||||TWO_SIDED|95.0|-0.86|0.51||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Week 6, 8AM Difference between Implant Group 2 and timolol||0.51|-0.86|
70859846|NCT03519386|141206103|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-0.77|||||TWO_SIDED|95.0|-1.43|-0.11||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Week 6, 10AM Difference between Implant Group 2 and timolol||-0.11|-1.43|
70859847|NCT03519386|141206103|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.63|0.82||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Month 3, 8AM Difference between Implant Group 2 and timolol||0.82|-0.63|
70859848|NCT03519386|141206103|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-0.16|||||TWO_SIDED|95.0|-0.89|0.57||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Month 3, 10AM Difference between Implant Group 2 and timolol||0.57|-0.89|
70859849|NCT03519386|141206103|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs. Timolol|Mean Difference (Final Values)|-0.72|||||TWO_SIDED|95.0|-1.38|-0.06||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Day 10, 8AM Difference between Implant Group 1 vs. Timolol||-0.06|-1.38|
70954366|NCT03568318|141411395|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|48.8|||<|0.001|TWO_SIDED|95.0|41.9|55.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||55.7|41.9|<0.001
71130710|NCT00620113|141765148|SUPERIORITY_OR_OTHER||Difference in LS Means|-12.55||||0.009|TWO_SIDED|95.0|-22.16|-2.94||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-2.94|-22.16|0.009
71130711|NCT00620113|141765148|SUPERIORITY_OR_OTHER||Difference in LS Means|2.48||||0.598|TWO_SIDED|95.0|-7.79|12.74||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||12.74|-7.79|0.598
71130712|NCT00620113|141765149|SUPERIORITY_OR_OTHER||Difference in LS Means|-26.86|||<|0.001|TWO_SIDED|95.0|-43.3|-10.42||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-10.42|-43.30|<0.001
71130713|NCT00620113|141765149|SUPERIORITY_OR_OTHER||Difference in LS Means|-28.86|||<|0.001|TWO_SIDED|95.0|-44.97|-12.75||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-12.75|-44.97|<0.001
70859850|NCT03519386|141206103|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|-1.15|||||TWO_SIDED|95.0|-1.83|-0.48||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Day 10, 10AM Difference between Implant Group 1 vs. Timolol||-0.48|-1.83|
70859851|NCT03519386|141206103|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs. Timolol|Mean Difference (Final Values)|-0.25|||||TWO_SIDED|95.0|-0.93|0.43||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Week 6, 8AM Difference between Implant Group 1 and timolol||0.43|-0.93|
70859852|NCT03519386|141206103|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|-0.74|||||TWO_SIDED|95.0|-1.4|-0.08||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Week 6, 10AM Difference between Implant Group 1 and timolol||-0.08|-1.40|
70859853|NCT03519386|141206103|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs. Timolol|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.62|0.83||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Month 3, 8AM Difference between Implant Group 1 and timolol||0.83|-0.62|
70859854|NCT03519386|141206103|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.77|0.69||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Month 3, 10AM Difference between Implant Group 1 and timolol||0.69|-0.77|
70859855|NCT01582854|141206106|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.82||0.005|TWO_SIDED|95.0|-3.9|-0.7|||ANCOVA|||||-0.7|-3.9|0.005
70859856|NCT01582854|141206107|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.74||0.122|TWO_SIDED|95.0|-2.6|0.3|||ANCOVA|||Month 3||0.3|-2.6|0.122
70859857|NCT01582854|141206107|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|0.93|<|0.001|TWO_SIDED|95.0|-5.5|-1.9|||ANCOVA|||Month 12||-1.9|-5.5|<0.001
70859858|NCT01582854|141206108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.111|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||End of Infusion Period||0.7|-0.1|0.111
70859859|NCT01582854|141206108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.27||0.016|TWO_SIDED|95.0|0.1|1.2|||ANCOVA|||Month 3||1.2|0.1|0.016
70859860|NCT01582854|141206108|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.29||0.013|TWO_SIDED|95.0|0.2|1.3|||ANCOVA|||Month 6||1.3|0.2|0.013
70859861|NCT01582854|141206108|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.34||0.003|TWO_SIDED|95.0|0.3|1.7|||ANCOVA|||Month 12||1.7|0.3|0.003
70859862|NCT01582854|141206109|SUPERIORITY_OR_OTHER||Percent Difference|10.2||||0.032|TWO_SIDED|95.0|0.9|19.5|||Chi-squared|||Month 3||19.5|0.9|0.032
70859863|NCT01582854|141206109|SUPERIORITY_OR_OTHER||Percent Difference|10.2||||0.034|TWO_SIDED|95.0|0.8|19.5|||Chi-squared|||Month 6||19.5|0.8|0.034
70859864|NCT01582854|141206109|SUPERIORITY_OR_OTHER||Percent Difference|10.1||||0.035|TWO_SIDED|95.0|0.8|19.3|||Chi-squared|||Month 12||19.3|0.8|0.035
70859865|NCT01582854|141206110|SUPERIORITY_OR_OTHER||Percent Difference|-3.2||||0.251|TWO_SIDED|95.0|-8.5|2.1|||Fisher Exact|||Month 6||2.1|-8.5|0.251
70859866|NCT01582854|141206110|SUPERIORITY_OR_OTHER||Percent Difference|-4.0||||0.221|TWO_SIDED|95.0|-9.7|1.7|||Fisher Exact|||Month 12||1.7|-9.7|0.221
70859867|NCT01582854|141206111|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.239|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||End of Infusion Period||0.1|-0.4|0.239
70859868|NCT01582854|141206111|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.136|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||Month 3||0.1|-0.5|0.136
70859869|NCT01582854|141206111|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.89|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|||Month 6||0.2|-0.3|0.890
70859870|NCT01582854|141206111|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.455|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||Month 12||0.2|-0.4|0.455
70859871|NCT06138145|141206118|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
70859872|NCT06138145|141206118|OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mann-Whitney U test|||||||<0.05
70859873|NCT06138145|141206118|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70859874|NCT02652767|141206119|SUPERIORITY||Mean Difference (Net)|-0.012||||0.889|TWO_SIDED|95.0|-0.182|0.158|||ANCOVA|||A mixed model of analysis of covariance (ANCOVA) was used with change from baseline at Week 48 as the response, and participants, eyes of the participant as random factor, treatment and baseline LogMAR value as covariates in the model. P-value is used to assess the significance of the difference between All-GS010 and All-Sham with respect to change of LogMAR from baseline.||0.158|-0.182|0.8890
70859875|NCT00107952|141206144|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 20% was specified based on historical regulatory precedent.|Risk Difference (RD)|-1.6||||||95.0|-8.6|5.5||p-values were not calculated in deference to confidence intervals.|||"Statistical analysis applies to cure"|||5.5|-8.6|
70859876|NCT03614975|141206171|OTHER|||||||0.28||||||A/H1N1|Chi-squared|||||||0.28
70859877|NCT03614975|141206171|OTHER|||||||0.64||||||A/H3N2|Chi-squared|||||||0.64
70954367|NCT03568318|141411395|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|36.8|||<|0.001|TWO_SIDED|95.0|29.7|43.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||43.8|29.7|<0.001
70859878|NCT03614975|141206171|OTHER|||||||0.64||||||B/Colorado|Chi-squared|||||||0.64
70859879|NCT03614975|141206171|OTHER|||||||0.23||||||B/Phuket|Chi-squared|||||||0.23
71130714|NCT00620113|141765149|SUPERIORITY_OR_OTHER||Difference in LS Means|-5.61||||0.458|TWO_SIDED|95.0|-23.79|12.56||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||12.56|-23.79|0.458
71130715|NCT01979133|141765163|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||.012
71130716|NCT01979133|141765164|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.005
71130717|NCT01979133|141765165|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.017
71130718|NCT01979133|141765166|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.038
71130719|NCT01979133|141765167|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.034
71130720|NCT01979133|141765168|SUPERIORITY_OR_OTHER|||||||0.231|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.231
71130721|NCT01979133|141765169|SUPERIORITY_OR_OTHER|||||||0.066|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.066
71130722|NCT00486824|141765170|SUPERIORITY|||||||0.004|||||||Fisher Exact|||||||0.004
71130723|NCT00082407|141765222|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified non-inferiority margin was 0.4% (i.e., noninferiority is demonstrated if the upper limit of a two-sided 95% confidence interval for the difference in change in HbA1c between exenatide and biphasic insulin aspart is less than 0.4%.)|Mean Difference (Final Values)|-0.1||||0.2534||95.0|-0.28|0.08|||ANCOVA|||||0.08|-0.28|0.2534
71130724|NCT00082407|141765223|SUPERIORITY_OR_OTHER|||||||0.0779||95.0|||||Fisher Exact|||||||0.0779
71130725|NCT00082407|141765224|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANCOVA|||||||0.0001
71130726|NCT00082407|141765225|SUPERIORITY_OR_OTHER|||||||0.6456||95.0|||||ANCOVA|||||||0.6456
71130727|NCT00082407|141765227|SUPERIORITY_OR_OTHER|||||||0.7888||95.0|||||Fisher Exact|||||||0.7888
71130728|NCT00082407|141765228|SUPERIORITY_OR_OTHER|||||||0.3722||95.0|||||ANCOVA|||||||0.3722
71130729|NCT00118742|141765237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.9||||0.0012||95.0|14.8|35.0|||ANCOVA|||||35.0|14.8|0.0012
71130730|NCT00118742|141765238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.6|||<|0.0001||95.0|15.7|35.6|||ANCOVA|||||35.6|15.7|<0.0001
71130731|NCT00118742|141765239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.7||||0.0053||95.0|13.7|43.7|||ANCOVA|||||43.7|13.7|0.0053
71130732|NCT00118742|141765240|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|21.1|||<|0.0001||95.0|12.5|29.6|||ANCOVA|||Statistical analysis for calculated creatinine clearance at 6 months posttransplant||29.6|12.5|<0.0001
71130733|NCT00118742|141765240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.2|||<|0.0001||95.0|9.9|26.6|||ANCOVA|||Statistical analysis for calculated creatinine clearance at 12 months posttransplant||26.6|9.9|<0.0001
71130734|NCT00118742|141765240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.6||||0.0006||95.0|10.2|37.0|||ANCOVA|||Statistical analysis for calculated creatinine clearance at 24 months posttransplant||37.0|10.2|0.0006
71130735|NCT00856544|141765276|SUPERIORITY_OR_OTHER||Percent difference|27.04|||<|0.0001|TWO_SIDED|95.0|17.94|36.13||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation to the binomial distribution was used to test the superiority of each dose of CP-690,550 10 mg to placebo and 2-sided 95% confidence interval (CI) was evaluated for the difference in percentages.||36.13|17.94|<0.0001
71130736|NCT00856544|141765276|SUPERIORITY_OR_OTHER||Percent Difference|21.52|||<|0.0001|TWO_SIDED|95.0|12.39|30.65||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal Approximation|||Normal approximation to the binomial distribution was used to test the superiority of each dose of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||30.65|12.39|<0.0001
71130737|NCT00856544|141765277|SUPERIORITY_OR_OTHER||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.44|-0.26||A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant, the comparison of 10 mg to placebo in ACR20 had to be significant.|Mixed Models Analysis|||Least squares mean difference (LS Mean Difference) and corresponding 95% CI was calculated using a mixed effect repeated measure model with treatments, visits and treatment-by-visit interaction as fixed effects and participants as a random effect.||-0.26|-0.44|<0.0001
70859880|NCT03614975|141206172|OTHER|||||||0.42||||||Vaccine Strain: A/H1N1:Day 0|Chi-squared|||||||0.42
70859881|NCT03614975|141206172|OTHER|||||||0.16||||||Vaccine Strain: A/H1N1: Day 21|Chi-squared|||||||0.16
70859882|NCT03614975|141206172|OTHER|||||||0.42||||||Vaccine Strain: A/H3N2: Day 0|Chi-squared|||||||0.42
70859883|NCT03614975|141206172|OTHER|||||||0.94||||||Vaccine Strain: A/H3N2: Day 21|Chi-squared|||||||0.94
70859884|NCT03614975|141206172|OTHER|||||||0.87||||||Vaccine Strain: B/Colorado :Day 0|Chi-squared|||||||0.87
70859885|NCT03614975|141206172|OTHER|||||||0.77||||||Vaccine Strain: B/Colorado : Day 21|Chi-squared|||||||0.77
70859886|NCT03614975|141206172|OTHER|||||||0.33||||||Vaccine Strain: B/Phuket: Day 0|Chi-squared|||||||0.33
70859887|NCT03614975|141206172|OTHER|||||||0.21||||||Vaccine Strain: B/Phuket: Day 21|Chi-squared|||||||0.21
70859888|NCT03614975|141206173|OTHER|||||||0.49||||||Vaccine Strain: A/H1N1: Day 0|Kruskal-Wallis|||||||0.49
70859889|NCT03614975|141206173|OTHER|||||||0.23||||||Vaccine Strain: A/H1N1: Day 21|Kruskal-Wallis|||||||0.23
70859890|NCT03614975|141206173|OTHER|||||||0.1||||||Vaccine Strain: A/H3N2: Day 0|Kruskal-Wallis|||||||0.10
70947049|NCT03311269|141394371|OTHER|The null hypothesis is that the mean change from baseline for the primary efficacy endpoint=0. The alternative hypothesis is that the mean change does not =0. The primary analysis will be a one-sample t-test for both treatment groups combined, to test the null hypothesis that the mean change from baseline equals 0. Primary analysis will be performed for each treatment group separately.|Mean Difference (Final Values)|-4.2|||<|0.001|TWO_SIDED|95.0|-6.2|-2.3||This p-value corresponds to the change from Baseline to Week 12 for both treatment groups (ClariVein RES 1% Injection and ClariVein RES 3% Injection) combined.|t-test, 2 sided|One-Sample||Continuous variables summarized using descriptive statistics, specifically the mean, median, standard deviation, minimum and maximum. Categorical variables summarized using frequencies and percentages. All statistical tests will be performed at the 0.05 significance level (p -value ≤ 0.050) unless otherwise indicated. For efficacy analyses, missing post-treatment data will be imputed using last observation carried forward (LOCF). Missing safety data will not be imputed.||-2.3|-6.2|<0.001
70947050|NCT03311269|141394371|OTHER|The null hypothesis is that the mean change from baseline for the primary efficacy endpoint=0. The alternative hypothesis is that the mean change does not =0. The primary analysis will be a one-sample t-test for both treatment groups combined, to test the null hypothesis that the mean change from baseline equals 0. Primary analysis will be performed for each treatment group separately.|Mean Difference (Final Values)|-3.4||||0.011|TWO_SIDED|95.0|-5.8|-1.0||This p-value corresponds to the change from Baseline to Week 12 for the ClariVein RES 1% Injection treatment group.|t-test, 2 sided|One-Sample||All statistical tests will be performed at the 0.05 significance level (p -value ≤ 0.050) unless otherwise indicated.||-1.0|-5.8|0.011
71130738|NCT00856544|141765277|SUPERIORITY_OR_OTHER||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.35|-0.16||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in ACR20 had to be statistically significant.|Mixed Models Analysis|||LS Mean Difference and corresponding 95% CI was calculated using a mixed effect repeated measure model with treatments, visits and treatment-by-visit interaction as fixed effects and participants as a random effect.||-0.16|-0.35|<0.0001
70859891|NCT03614975|141206173|OTHER|||||||0.86||||||Vaccine Strain: A/H3N2: Day 21|Kruskal-Wallis|||||||0.86
70859892|NCT03614975|141206173|OTHER|||||||0.73||||||Vaccine Strain: B/Colorado: Day 0|Kruskal-Wallis|||||||0.73
70859893|NCT03614975|141206173|OTHER|||||||0.67||||||Vaccine Strain: B/Colorado: Day 21|Kruskal-Wallis|||||||0.67
70859894|NCT03614975|141206173|OTHER|||||||0.36||||||Vaccine Strain: B/Phuket: Day 0|Kruskal-Wallis|||||||0.36
70859895|NCT03614975|141206173|OTHER|||||||0.65||||||Vaccine Strain: B/Phuket: Day 21|Kruskal-Wallis|||||||0.65
70859896|NCT01569464|141206180|SUPERIORITY_OR_OTHER||LS Mean|-0.27|STANDARD_ERROR_OF_MEAN|1.36||0.8451|TWO_SIDED|95.0|-2.96|2.42||A hierarchical test procedure was done for the primary efficacy variables at an α-level of 5 %. If a test was statistically significant, a test for the next variable was performed. If a test was not statistically significant the procedure stopped.|ANCOVA|||ANCOVA model was used for analysis with fixed effects for treatment assignment (main factor) and the subject's investigational center (stratifying factor) and a covariate for the Baseline Visit value of the IRLS sum score.||2.42|-2.96|0.8451
70859897|NCT01569464|141206181|SUPERIORITY_OR_OTHER||LS Mean|0.07|STANDARD_ERROR_OF_MEAN|0.34||0.8336|TWO_SIDED|95.0|-0.61|0.75||A hierarchical test procedure was done for the primary efficacy variables at an α-level of 5 %. If a test was statistically significant, a test for the next variable was performed. If a test was not statistically significant the procedure stopped.|ANCOVA|||ANCOVA model was used for analysis with fixed effects for treatment assignment (main factor) and the subject's investigational center (stratifying factor) and a covariate for the Baseline Visit value of the IRLS sum score.||0.75|-0.61|0.8336
70859898|NCT01390220|141206202|SUPERIORITY|||||||0.0109|||||||Fisher Exact|2-sided||||||0.0109
70859899|NCT01390220|141206203|SUPERIORITY|||||||0.0043|||||||Fisher Exact|2-sided||||||0.0043
70859900|NCT01390220|141206204|SUPERIORITY|||||||0.0124|||||||Log Rank|||||||0.0124
70859901|NCT01390220|141206205|SUPERIORITY|||||||0.0124|||||||Log Rank|||Kaplan-Meier estimates.||||0.0124
70859902|NCT04718103|141206219|SUPERIORITY|Analysis performed using a generalized linear model assuming a negative binomial distribution and covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region and baseline pre-bronchodilator percent predicted Forced Expiratory Volume in one second (FEV1) and offset of log (total time in the study in years).|Rate Ratio|0.52|||<|0.001|TWO_SIDED|95.0|0.36|0.73|||Negative Binomial Distribution|||To demonstrate the superiority of GSK3511294 100 mg SC + SoC following two doses (at Week 0 and at Week 26) compared with placebo + SoC, assessed by the annualized rate of clinically significant exacerbations measured over the study intervention period of 52 weeks.||0.73|0.36|<0.001
70859903|NCT04718103|141206220|SUPERIORITY||Least-square (LS) means|-2.31||||0.2|TWO_SIDED|95.0|-5.84|1.23|||Mixed Models Repeated Measures (MMRM)|||To demonstrate the superiority of GSK3511294 100 mg SC + SoC following two doses (at Week 0 and at Week 26) compared with placebo + SoC, assessed by SGRQ Total Score measured over the study intervention period of 52 weeks.||1.23|-5.84|0.200
70859904|NCT04718103|141206221|SUPERIORITY||Difference in Least-Square Mean|-0.11||||0.333|TWO_SIDED|95.0|-0.33|0.11|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ACQ-5 score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ACQ-5 score and visit by treatment group.||0.11|-0.33|0.333
70859905|NCT04718103|141206222|SUPERIORITY||Difference in Least-Square Means|0.056||||0.267|TWO_SIDED|95.0|-0.043|0.154|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline pre-bronchodilator FEV1, visit, visit by baseline pre-bronchodilator FEV1 and visit by treatment group.||0.154|-0.043|0.267
70859906|NCT04718103|141206223|SUPERIORITY||Difference in Least square means|-0.21||||0.173|TWO_SIDED|95.0|-0.52|0.09|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ANSD weekly mean score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ANSD weekly mean score and visit by treatment group.||0.09|-0.52|0.173
70859907|NCT04718103|141206224|SUPERIORITY||Difference in Least square means|-0.21||||0.138|TWO_SIDED|95.0|-0.48|0.07|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ADSD weekly mean score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ADSD weekly mean score and visit by treatment group.||0.07|-0.48|0.138
70859908|NCT04718103|141206225|SUPERIORITY|Analysis performed using a generalized linear model assuming a negative binomial distribution and covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region and baseline pre-bronchodilator percent predicted FEV1.|Rate Ratio|0.42||||0.087|TWO_SIDED|95.0|0.16|1.13|||Negative binomial distribution|||||1.13|0.16|0.087
70954368|NCT03568318|141411396|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|49.9|||<|0.001|TWO_SIDED|95.0|43.3|56.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||56.4|43.3|<0.001
70859909|NCT00136604|141206226|NON_INFERIORITY|Criterion for non-inferiority evaluation: The lower limit (LL) of the standardized asymptotic 95% confidence interval (CI) on the difference in the percentage of subjects with SBA-MenC titre ≥ 1:128 between the Tritanrix-Hepb/Hib-MenAC-TT Group and (minus) the TRITANRIX-HEPB+Mencevax + Meningitec control group was above -10%.|Difference in percentage of subjects|0.0|||||TWO_SIDED|95.0|-1.53|3.05||||||Demonstration of non-inferiority of a fourth dose of the Tritanrix-HepB/Hib-MenAC-TT vaccine versus a fourth dose of the Tritanrix-HepB/Hiberix and Meningitec vaccine given concomitantly in terms of the percentage of subjects with an SBA-MenC titre ≥ 1:128.||3.05|-1.53|
70859910|NCT00136604|141206228|NON_INFERIORITY|Criterion for non-inferiority evaluation: The lower limit (LL) of the standardized asymptotic 95% CI on the difference in seroprotection (anti-PRP concentration ≥ 1.0 µg/mL) between the Tritanrix-Hepb/Hib-MenAC-TT Group and (minus) the Tritanrix-Hepb/Mencevax+Tritanrix-HepB/Hiberix Group was above -10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-1.53|3.05||||||Demonstration of non-inferiority of the Tritanrix-HepB/Hib-MenAC-TT vaccine versus the Tritanrix-HepB/Hiberix vaccine when used as a booster vaccine in Tritanrix-HepB/Hib-MenAC-TT primed subjects in terms of the percentage of subjects with an anti-PRP concentration ≥ 1.0 µg/mL.||3.05|-1.53|
70947051|NCT03311269|141394371|OTHER|The null hypothesis is that the mean change from baseline for the primary efficacy endpoint=0. The alternative hypothesis is that the mean change does not =0. The primary analysis will be a one-sample t-test for both treatment groups combined, to test the null hypothesis that the mean change from baseline equals 0. Primary analysis will be performed for each treatment group separately.|Mean Difference (Final Values)|-5.1||||0.01|TWO_SIDED|95.0|-8.7|-1.6||This p-value corresponds to the change from Baseline to Week 12 for the ClariVein RES 3% Injection treatment group.|t-test, 2 sided|One-Sample||All statistical tests will be performed at the 0.05 significance level (p -value ≤ 0.050) unless otherwise indicated.||-1.6|-8.7|0.010
70859911|NCT00633867|141206261|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Log Rank|||||||<0.01
70859912|NCT01876810|141206283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1|TWO_SIDED|95.0||||For all analyses, results are considered significant at p\<.05.|t-test, 2 sided|||||||0.1
70859913|NCT01876810|141206283|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.1|TWO_SIDED|95.0||||For all analyses, results were considered significant at p\< 0.05|t-test, 2 sided|||||||0.1
70859914|NCT01876810|141206284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|0.034||0.9|TWO_SIDED|95.0||||For all analyses, results were considered significant at p\< 0.05|t-test, 2 sided|||||||0.9
70859915|NCT01876810|141206284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|0.05||0.9|TWO_SIDED|95.0||||For all analyses, results were considered significant at p\< 0.05|t-test, 2 sided|||||||0.9
70859916|NCT01876810|141206285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.3|STANDARD_ERROR_OF_MEAN|31.7||0.4|TWO_SIDED|95.0|||||ANOVA|Repeated-measures ANOVA on Drug X Cue X Time were used|participants self-reportd VAS craving at the time of neutral cue presentation|||||0.4
70859917|NCT01876810|141206285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.7|STANDARD_ERROR_OF_MEAN|26.5||0.4|TWO_SIDED|95.0||||For all analyses, results were considered significant at p\< 0.05|ANOVA|Repeated-measures ANOVA on Drug X Cue X Time were used||||||0.4
70859918|NCT05523323|141206310|OTHER||Estimate difference|29.5||||0.0002014|TWO_SIDED|95.0|14.0|43.9|||Unstratified Miettinen & Nurminen method|One-sided p-value was calculated using the unstratified Miettinen \& Nurminen method.|The exact binomial method by Clopper and Pearson was used to generate the estimate difference and the associated 95% confidence intervals (CIs).|||43.9|14.0|0.0002014
70859919|NCT05523323|141206311|OTHER||Hazard Ratio (HR)|0.34||||3.7e-06|TWO_SIDED|95.0|0.21|0.55|||unstratified Log-rank test.|One-sided p-value was calculated using unstratified Log-rank test.|The unstratified Cox-Regression model with Efron's method of tie handling with treatment as covariate was used to generate Hazard Ratio (HR) and the associated 95%CI.|||0.55|0.21|0.0000037
71130739|NCT00856544|141765278|SUPERIORITY_OR_OTHER||Percent difference|10.63|||<|0.0001|TWO_SIDED|95.0|5.8|15.45||A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant, the comparison of 10 mg to placebo in HAQ-DI had to be significant.|Normal Approximation|||Normal approximation to the binomial distribution was used to test the superiority of each dose of CP-690,550 10 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||15.45|5.80|<0.0001
71130740|NCT00856544|141765278|SUPERIORITY_OR_OTHER||Percent difference|6.42||||0.0038|TWO_SIDED|95.0|2.07|10.77||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.|Normal Approximation|||Normal approximation to the binomial distribution was used to test the superiority of each dose of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||10.77|2.07|0.0038
71130741|NCT00787189|141765323|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0005||95.0|||||Fisher Exact|||||||<0.0005
70859920|NCT05523323|141206312|OTHER||Hazard Ratio (HR)|0.86||||0.30933|TWO_SIDED|95.0|0.49|1.54|||Unstratified Log-rank test|One-sided p-value was calculated using unstratified Log-rank test.|The unstratified Cox-Regression model with Efron's method of tie handling with treatment as covariate was used to generate Hazard Ratio (HR) and the associated 95%CI.|||1.54|0.49|0.30933
70859921|NCT01948310|141206322|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||2-0 weeks||||>0.05
70859922|NCT01948310|141206322|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||0-14 weeks||||0.03
70859923|NCT01948310|141206322|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||2-0 weeks||||>0.05
70859924|NCT01948310|141206322|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||14-0 weeks||||0.005
70859925|NCT01948310|141206323|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||2-0 weeks||||>0.05
70859926|NCT01948310|141206323|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||14-0 weeks||||>0.05
70859927|NCT01948310|141206323|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||2-0 weeks||||0.03
70859928|NCT01948310|141206323|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||14-0 weeks||||>0.05
70859929|NCT01948310|141206324|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||2-0 weeks||||>0.05
70859930|NCT01948310|141206324|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||0-14 weeks||||0.13
70859931|NCT01948310|141206324|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||2-0 weeks||||>0.05
70859932|NCT01948310|141206324|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||14-0 weeks||||0.013
70859933|NCT00920829|141206333|SUPERIORITY|||||||0.724|||||||Mixed Models Analysis|||A linear mixed model with unstructured variance/covariance matrices was used to evaluate the primary outcome measure.||||0.724
70859934|NCT00920829|141206333|SUPERIORITY|||||||0.023|||||||Mixed Models Analysis|||This is a test of the main effect of medication, with a null hypothesis of no difference between Naltrexone and Placebo groups.||||0.023
70859935|NCT05654441|141206337|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
70859936|NCT05654441|141206338|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
70859937|NCT05654441|141206339|OTHER|||||||0.007|||||||ANOVA|||||||0.007
70859938|NCT05654441|141206340|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
70859939|NCT05654441|141206341|OTHER|||||||0.886|||||||t-test, 2 sided|||||||0.886
70859940|NCT05654441|141206342|OTHER|||||||0.666|||||||t-test, 2 sided|||||||.666
70859941|NCT05654441|141206343|OTHER|||||||0.522|||||||t-test, 2 sided|||||||.522
70859942|NCT05654441|141206344|OTHER|||||||0.438|||||||t-test, 2 sided|||||||.438
70859943|NCT05654441|141206345|OTHER|||||||0.181|||||||t-test, 2 sided|||||||.181
70859944|NCT05654441|141206346|OTHER|||||||0.833|||||||t-test, 2 sided|||||||.833
70859945|NCT05654441|141206347|OTHER|||||||0.455|||||||t-test, 2 sided|||||||.455
70859946|NCT03718871|141206392|SUPERIORITY||intracluster correlation coefficient|0.086|||<|0.001|TWO_SIDED|95.0|0.015|0.363||The threshold for significance was set at p \< 0.05.|Fisher Exact|||Given that the intervention arm showed 100% uptake, a multi-level regression model could not be created with a zero in the denominator in the intervention group. We therefore used Fisher's exact test to assess for significant differences in proportion of HIV testing between study arms.||0.363|0.015|<0.001
70859947|NCT03718871|141206393|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
70859948|NCT03718871|141206394|SUPERIORITY|||||||0.015|||||||Fisher Exact|||||||0.015
70859949|NCT03718871|141206395|OTHER|No comparison between study arm groups was made in this analysis, as it was limited to control arm only.|Odds Ratio (OR)|1.04|STANDARD_DEVIATION|0.039|<|0.01|TWO_SIDED|95.0|1.02|1.06||Significance threshold two-sided alpha = 0.05|Regression, Linear|||We considered variables that predicted the primary outcome of receiving an HIV test among control arm only, as uptake was 100% in the intervention. First we identified variables that were significant (two-sided p-value\<0.05) in univariate analysis and creating multivariate mixed-effects logistic regression model accounting for covariates and intercorrelation between participants from the same healer by including healers as random effects.||1.06|1.02|<0.01
70859950|NCT03718871|141206396|OTHER|No comparison was made with the intervention arm|Odds Ratio (OR)|0.56||||0.07|TWO_SIDED|95.0|0.3|1.04||Univariate analysis|Fisher Exact|||We considered variables that predicted the primary outcome of receiving an HIV test among control arm only, as uptake was 100% in the intervention. First we identified variables that were significant (two-sided p-value\<0.05) in univariate analysis and creating multivariate mixed-effects logistic regression model accounting for covariates and intercorrelation between participants from the same healer by including healers as random effects.||1.04|0.30|0.07
70859951|NCT03718871|141206397|OTHER|Comparison between study arms was not performed|Odds Ratio (OR)|0.43||||0.09|TWO_SIDED|95.0|0.16|1.18|||Fisher Exact|||We considered variables that predicted the primary outcome of receiving an HIV test among control arm only, as uptake was 100% in the intervention. First we identified variables that were significant (two-sided p-value\<0.05) in univariate analysis and creating multivariate mixed-effects logistic regression model accounting for covariates and intercorrelation between participants from the same healer by including healers as random effects.||1.18|0.16|0.09
70859952|NCT00749580|141206427|SUPERIORITY_OR_OTHER|||||||0.935|||||||Fisher Exact|||||||0.935
70859953|NCT03868124|141206432|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-1.25|||||TWO_SIDED|95.0|-1.99|-0.5||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Day 10, 8AM Difference between Implant Group 2 and timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||-0.50|-1.99|
70859954|NCT03868124|141206432|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-1.88|-0.52||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Month 3, 10AM Difference between Implant Group 2 and timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||-0.52|-1.88|
70859955|NCT03868124|141206432|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.76|0.69||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Week 6, 8AM Difference between Implant Group 2 and timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||0.69|-0.76|
70859956|NCT03868124|141206432|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|0.32|||||TWO_SIDED|95.0|-0.37|1.01||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Week 6, 10AM Difference between Implant Group 2 and Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||1.01|-0.37|
70859957|NCT03868124|141206432|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|0.16|||||TWO_SIDED|95.0|-0.59|0.91||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Month 3, 8AM Difference between Implant Group 2 and timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||0.91|-0.59|
70859958|NCT03868124|141206432|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.77|0.71||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Month 3, 10AM Difference between Implant Group 2 and timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||0.71|-0.77|
70859959|NCT03868124|141206432|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs. Timolol|Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-1.84|-0.36||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Day 10, 8AM Difference between Implant Group 1 vs. Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||-0.36|-1.84|
70859960|NCT03868124|141206432|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|-1.13|||||TWO_SIDED|95.0|-1.81|-0.45||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Day 10, 10AM Difference between Implant Group 1 vs. Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||-0.45|-1.81|
70859961|NCT03868124|141206432|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|0.33|||||TWO_SIDED|95.0|-0.39|1.06||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Week 6, 8AM Difference between Implant Group 1 vs. Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||1.06|-0.39|
70859962|NCT03868124|141206432|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|0.23|||||TWO_SIDED|95.0|-0.46|0.93||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Week 6, 10AM Difference between Implant Group 1 vs. Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||0.93|-0.46|
70859963|NCT03868124|141206432|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|0.53|||||TWO_SIDED|95.0|-0.23|1.28||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Month 3, 8AM Difference between Implant Group 1 and Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||1.28|-0.23|
70859964|NCT03868124|141206432|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|0.55|||||TWO_SIDED|95.0|-0.19|1.29||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Month 3, 10AM Difference between Implant Group 1 and Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||1.29|-0.19|
70859965|NCT01117051|141206449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.305||95.0|||||Cochran-Mantel-Haenszel|||||||0.305
70859966|NCT00366340|141206499|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-2.5|2.6||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.6|-2.5|
70859967|NCT00366340|141206499|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-9.6|||||TWO_SIDED|95.0|-16.0|-3.3||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||-3.3|-16.0|
70859968|NCT00366340|141206499|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|2.2|||||TWO_SIDED|95.0|-0.4|5.2||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||5.2|-0.4|
70947052|NCT03311269|141394371|OTHER|An ANCOVA was performed to compare the change from baseline for ClariVein RES 1% Injection versus ClariVein RES 3% Injection with treatment as the class variable and with baseline score as the covariate|Least-Squares Mean Difference|-1.2||||0.531|TWO_SIDED|95.0|-3.7|1.3||This p-value corresponds to the difference between treatment groups (ClariVein RES 1% Injection versus ClariVein RES 3% Injection).|ANCOVA|||All statistical tests will be performed at the 0.05 significance level (p -value ≤ 0.050) unless otherwise indicated.||1.3|-3.7|0.531
70859969|NCT00366340|141206499|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|1.5|||||TWO_SIDED|95.0|-0.9|4.1||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.1|-0.9|
70859970|NCT00366340|141206499|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-1.4|||||TWO_SIDED|95.0|-4.2|1.2||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.2|-4.2|
70859971|NCT00366340|141206499|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.3|||||TWO_SIDED|95.0|-3.8|3.3||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.3|-3.8|
71130742|NCT05274269|141765342|SUPERIORITY||LS Mean difference|9.2|||<|0.0001|TWO_SIDED|95.0|7.2|11.3|||Mixed Models for Repeated Measures|||||11.3|7.2|< 0.0001
71130743|NCT05274269|141765343|SUPERIORITY||LS Mean difference|-28.3|||<|0.0001|TWO_SIDED|95.0|-32.1|-24.5|||Mixed Models for Repeated Measures|||||-24.5|-32.1|< 0.0001
71130744|NCT05274269|141765344|SUPERIORITY||LS Mean difference|19.5|||<|0.0001|TWO_SIDED|95.0|15.5|23.5|||Mixed Models for Repeated Measures|||||23.5|15.5|< 0.0001
71130745|NCT05274269|141765345|SUPERIORITY||LS Mean difference|0.47|||<|0.0001|TWO_SIDED|95.0|0.24|0.69|||Mixed Models for Repeated Measures|||||0.69|0.24|< 0.0001
70859972|NCT00366340|141206499|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.8|||||TWO_SIDED|95.0|-6.0|4.5||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.5|-6.0|
70859973|NCT00366340|141206500|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.73|||||TWO_SIDED|95.0|0.63|0.84||||||For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated||0.84|0.63|
70859974|NCT00366340|141206500|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.65|||||TWO_SIDED|95.0|0.52|0.82||||||For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated||0.82|0.52|
70859975|NCT00366340|141206500|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.84|||||TWO_SIDED|95.0|0.74|0.96||||||For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated||0.96|0.74|
70859976|NCT00366340|141206500|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.9|||||TWO_SIDED|95.0|0.76|1.07||||||For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated||1.07|0.76|
70859977|NCT00366340|141206500|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|2.25|||||TWO_SIDED|95.0|2.04|2.49||||||For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated||2.49|2.04|
70859978|NCT00366340|141206500|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.6|||||TWO_SIDED|95.0|0.51|0.71||||||For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated||0.71|0.51|
70859979|NCT00366340|141206500|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.88|||||TWO_SIDED|95.0|0.73|1.06||||||For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated||1.06|0.73|
70859980|NCT00366340|141206503|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|2.6|||||TWO_SIDED|95.0|-3.0|8.3||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated||8.3|-3.0|
70859981|NCT00366340|141206503|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|4.5|||||TWO_SIDED|95.0|-4.1|13.0||||||For Haemophilus influenzae type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated||13.0|-4.1|
70947053|NCT03311269|141394372|OTHER||Descriptive (Percentage)|94.4|||||TWO_SIDED|95.0|72.7|99.9|||||The count of the combined treatment group for the elimination of saphenous vein reflux at Week 12 posttreatment is 17/18 (94.4%).|The secondary efficacy endpoint, the elimination of saphenous vein reflux at Week 12 posttreatment, will be summarized for both treatments combined using the count and percentage, together with a 95% Wilson (score) confidence interval for the proportion.||99.9|72.7|
70859982|NCT00366340|141206503|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.5||||||For diphtheria toxoid the difference in percentages between the two groups(13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated||1.5|-1.4|
70859983|NCT00366340|141206503|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-4.5||||||95.0|-9.3|0.3||||||For diphtheria toxoid the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated||0.3|-9.3|
70859984|NCT00366340|141206503|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.5|1.5||||||For Haemophilus Influenzae Type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated||1.5|-1.5|
70859985|NCT00366340|141206503|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.3||||||95.0|-5.0|2.3||||||For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥ 10.0 mIU/mL threshold was calculated||2.3|-5.0|
70859986|NCT00366340|141206503|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|1.7|||||TWO_SIDED|95.0|-0.4|4.4||||||For Haemophilus influenzae type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated||4.4|-0.4|
70859987|NCT00366340|141206503|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For diphtheria toxoid the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated||1.4|-1.4|
70859988|NCT00366340|141206503|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For diphtheria toxoid the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated||1.4|-1.4|
70859989|NCT00366340|141206503|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.8||||||95.0|-1.3|3.3||||||For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥ 10.0 mIU/mL threshold was calculated||3.3|-1.3|
71130746|NCT05274269|141765346|SUPERIORITY||LS Mean difference|1.3|||<|0.0001|TWO_SIDED|95.0|0.6|1.9|||Mixed Models for Repeated Measures|||||1.9|0.6|< 0.0001
71130747|NCT02206035|141765350|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||Comparison at Baseline||||0.95
70859990|NCT00366340|141206504|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.23|||||TWO_SIDED|95.0|0.96|1.58||||||For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated||1.58|0.96|
70859991|NCT00366340|141206504|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.15|||||TWO_SIDED|95.0|0.95|1.39||||||For Haemophilus influenzae type b µg/mL the GMC ratio (13vPnC/7vPnC) was calculated||1.39|0.95|
70947054|NCT03311269|141394372|OTHER||Percentage Difference|11.1||||1|TWO_SIDED|95.0|-20.5|42.8||All statistical tests will be performed at the 0.05 significance level (p -value ≤ 0.050) unless otherwise indicated.|Chi-squared|||For elimination of saphenous vein reflux at Week 12 posttreatment, the treatment difference for ClariVein RES 1% Injection versus ClariVein RES 3% Injection for the proportion was assessed by a chi-square test together with a 95% Wilson (score) confidence interval for the treatment difference.||42.8|-20.5|1.000
70947055|NCT01182181|141394373|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.6|||||TWO_SIDED|90.0|92.34|98.95|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||98.95|92.34|
71130748|NCT02206035|141765350|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|||Comparison at Day 28||||0.26
71130749|NCT02206035|141765350|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||Comparison at Day 100||||0.63
71130750|NCT02206035|141765350|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||Comparison at Day 180||||0.76
71130751|NCT02206035|141765351|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||Comparison at Baseline||||0.99
71130752|NCT02206035|141765351|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||Comparison at Day 28||||0.48
71130753|NCT02206035|141765351|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||0.35
71130754|NCT02206035|141765351|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||Comparison at Day 180||||0.96
71130755|NCT02206035|141765352|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Comparison at Baseline||||<0.001
71130756|NCT02206035|141765352|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||Comparison at Day 28||||0.75
71130757|NCT02206035|141765352|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||Comparison at Day 100||||0.28
71130758|NCT02206035|141765352|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||Comparison at Day 180||||0.82
71130759|NCT02206035|141765353|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||Comparison at Baseline||||0.54
71130760|NCT02206035|141765353|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||Comparison at Day 28||||0.61
71130761|NCT02206035|141765353|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||Comparison at Day 100||||0.42
71130762|NCT02206035|141765353|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||Comparison at Day 180||||0.38
71130763|NCT02206035|141765354|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||Comparison at Baseline||||0.10
71130764|NCT02206035|141765354|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||Comparison at Day 28||||0.32
71130765|NCT02206035|141765354|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||Comparison at Day 100||||0.63
71130766|NCT02206035|141765354|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||Comparison at Day 180||||0.30
71130767|NCT05173012|141765359|SUPERIORITY||Least Squares (LS) Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.623||0.5325|TWO_SIDED|95.0|-0.84|1.62|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, and timepoint-by-treatment as explanatory variables, treated as fixed effects.|Difference was calculated as Monotherapy: SAGE-324 15 mg - placebo.|||1.62|-0.84|0.5325
71130768|NCT05173012|141765359|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.634||0.6549|TWO_SIDED|95.0|-1.54|0.97|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, and timepoint-by-treatment as explanatory variables, treated as fixed effects.|Difference was calculated as Monotherapy: SAGE-324 30 mg - placebo.|||0.97|-1.54|0.6549
71130769|NCT05173012|141765359|SUPERIORITY||LS Mean Difference|1.02|STANDARD_ERROR_OF_MEAN|0.7||0.1462|TWO_SIDED|95.0|-0.36|2.41|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, and timepoint-by-treatment as explanatory variables, treated as fixed effects.|Difference was calculated as Monotherapy: SAGE-324 60 mg - placebo.|||2.41|-0.36|0.1462
71130770|NCT05173012|141765360|SUPERIORITY||LS Mean Difference|2.04|STANDARD_ERROR_OF_MEAN|1.326||0.1271|TWO_SIDED|95.0|0.59|4.67|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, and timepoint-by-treatment as explanatory variables, treated as fixed effects.||||4.67|0.59|0.1271
71130771|NCT05173012|141765360|SUPERIORITY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|1.347||0.5642|TWO_SIDED|95.0|-3.45|1.89|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, and timepoint-by-treatment as explanatory variables, treated as fixed effects.||||1.89|-3.45|0.5642
71130772|NCT05173012|141765360|SUPERIORITY||LS Mean Difference|1.01|STANDARD_ERROR_OF_MEAN|1.439||0.486|TWO_SIDED|95.0|-1.84|3.85|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, and timepoint-by-treatment as explanatory variables, treated as fixed effects.||||3.85|-1.84|0.4860
71130773|NCT03668613|141765361|SUPERIORITY||Predicted Log-OR|4.862|||||TWO_SIDED|95.0|3.422|6.782|||Bayesian method using (MAP)|||Compared to historical placebo||6.782|3.422|
71130774|NCT03668613|141765361|SUPERIORITY||Predicted log-OR|4.836|||||TWO_SIDED|95.0|3.422|6.772|||Bayesian method using (MAP)|||Compared to historical placebo||6.772|3.422|
71130775|NCT03668613|141765362|SUPERIORITY||Predicted log -OR|4.292|||||TWO_SIDED|95.0|2.638|6.513|||Bayesian method using (MAP)|||Compared to historical placebo||6.513|2.638|
70947056|NCT01182181|141394374|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.3|||||TWO_SIDED|90.0|93.14|99.57|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||99.57|93.14|
70947057|NCT01121913|141394375|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LS means) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-t) is between 80% and 125%.|Mean ratio|102.0|||||TWO_SIDED|90.0|91.8|114.0|||||Trazodone Contramid® OAD (prototype 1)/Triticco®|||114|91.8|
70859992|NCT00366340|141206505|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.68|||||TWO_SIDED|95.0|0.57|0.8||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||0.80|0.57|
70859993|NCT00366340|141206505|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.87|||||TWO_SIDED|95.0|0.75|1.01||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||1.01|0.75|
70859994|NCT00366340|141206506|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.88|||||TWO_SIDED|95.0|0.69|1.11||||||For hepatitis B the GMC ratio (13vPnC/7vPnC) was calculated.||1.11|0.69|
70859995|NCT00366340|141206506|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.93|||||TWO_SIDED|95.0|0.71|1.22||||||For hepatitis B the GMC ratio (13vPnC/7vPnC) was calculated||1.22|0.71|
70859996|NCT03355664|141206511|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.38|TWO_SIDED|95.0|0.2|1.9|||Regression, Cox|||||1.9|0.2|0.38
70947058|NCT01121913|141394375|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LS means) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-t) is between 80% and 125%.|Mean ratio|105.0|||||TWO_SIDED|90.0|93.9|117.0|||||Trazodone Contramid® OAD (prototype 1)/Desyrel®|||117|93.9|
71130776|NCT03668613|141765362|SUPERIORITY||Predicted log-OR|4.606|||||TWO_SIDED|95.0|2.919|6.78|||Bayesian method using (MAP)|||Compared to historical placebo||6.780|2.919|
70947059|NCT01121913|141394375|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LS means) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-t) is between 80% and 125%.|Mean ratio|95.3|||||TWO_SIDED|90.0|85.5|106.0|||||Trazodone Contramid® OAD (prototype 2)/Triticco®|||106|85.5|
71130777|NCT03668613|141765363|SUPERIORITY||Predicted log-OR|4.367|||||TWO_SIDED|95.0|2.916|6.202|||Bayesian method using (MAP)|||||6.202|2.916|
71130778|NCT03668613|141765363|SUPERIORITY||Predicted log-OR|4.709|||||TWO_SIDED|95.0|3.201|6.58|||Bayesian method using (MAP)|||||6.580|3.201|
71130779|NCT00709618|141765373|SUPERIORITY_OR_OTHER||percentage of participants|41.0|||||TWO_SIDED|95.0|26.4|55.4|||||The estimated value respresents the percentage of participants with a complete response or a partial response.|||55.4|26.4|
71130780|NCT03781414|141765397|NON_INFERIORITY|The primary objective would be demonstrated, if the composite efficacy failure rate difference between any of the two CFZ533 arms and the TAC arm is less than the pre-defined non-inferiority margin (0.15) with probability \>80%.|Rate difference|0.0759|||||TWO_SIDED|95.0|-0.0729|0.2165||||||||0.2165|-0.0729|
71130781|NCT03781414|141765397|NON_INFERIORITY|The primary objective would be demonstrated, if the composite efficacy failure rate difference between any of the two CFZ533 arms and the TAC arm is less than the pre-defined non-inferiority margin (0.15) with probability \>80%.|Rate difference|0.1696|||||TWO_SIDED|95.0|0.0072|0.3276||||||||0.3276|0.0072|
71130782|NCT00719355|141765419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.25|STANDARD_DEVIATION|14.4||0.033|TWO_SIDED|95.0||||A priori level of significance was set at p \<0.05.|ANCOVA|Repeated-measures ANCOVA using intent-to-treat procedures, was used for the primary outcome variable. Analyses were adjusted for age.||Observed power for our primary analysis was 0.64.||||0.033
71130783|NCT00719355|141765420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|STANDARD_DEVIATION|3.65||0.109||95.0|||||ANCOVA|Repeated measures ANCOVA was used with intent to treat analysis. The co-variant was age.||||||0.109
71130784|NCT02932748|141765457|SUPERIORITY||||||<|0.0001||||||A global one-way ANOVA was followed by two pairwise t-tests on the comparisons of interest, i.e., IP vs. EUC, and GP vs IP for weight change across 6 months, evaluated at p ≤ 0.025, using both intent-to-treat and completer only data.|ANOVA|||||||<.0001
71130785|NCT00066963|141765465|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.8|||<|0.001|TWO_SIDED|95.0|1.9|7.6|||Mantel Haenszel|2 d.f.|Counseling Only vs FV 2x/yr+Counseling|Planned sample size of 384 participants (128/study arm) (alpha = 0.05, power = 90%, 50% attrition, χ2 test) to detect caries incidence differences, based on caries incidence in the literature (20% to 50% over two years). 50% attrition in the sample size calculation was selected based on the literature (e.g. Weinstein et al., 1994 reported 53% attrition in six months.)||7.6|1.9|<0.001
71130786|NCT00988091|141765466|SUPERIORITY_OR_OTHER||Adjusted mean difference|5.33||||0.034|TWO_SIDED|95.0|0.41|10.24||The p-value was not adjusted for multiple comparisons because there was a single treatment comparison for the primary endpoint. The a priori threshold for statistical significance was p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate and study center as a stratification variable.||A treatment difference of \>=7.0 mm and a pooled SD of 27.6 mm, requires a sample size of 244 subjects/treatment to complete the trial at 80% power at a two-sided significance level of 5%. To account for 18% dropout rate, the sample size was increased to 298/arm (total of 596). The primary null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.||10.24|0.41|0.034
71130787|NCT00988091|141765467|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.89||||0.175|TWO_SIDED|95.0|-1.29|7.08||For secondary outcome measures, fixed-sequence testing was used in a sequentially rejective fashion. The a priori threshold for statistical significance was p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate and study center as a stratification variable.||The null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.||7.08|-1.29|0.175
71130788|NCT00988091|141765468|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.777||||0.193|TWO_SIDED|95.0|0.532|1.136||For secondary outcome measures, fixed-sequence testing was used in a sequentially rejective fashion. The a priori threshold for statistical significance was p \<0.05.|Regression, Logistic|The analysis included study center as a stratification variable.||The null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.||1.136|0.532|0.193
71130789|NCT00988091|141765469|SUPERIORITY_OR_OTHER|||||||0.887||95.0||||For secondary outcome measures, fixed-sequence testing was used in a sequentially rejective fashion. The a priori threshold for statistical significance was p \<0.05.|Cochran-Mantel-Haenszel|The analysis included study center as a stratification variable.||The null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.||||0.887
71130790|NCT00988091|141765471|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.0||||0.116|TWO_SIDED|95.0|-0.99|8.98||For secondary outcome measures, fixed-sequence testing was used in a sequentially rejective fashion. The a priori threshold for statistical significance was p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate and study center as a stratification variable.||The null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.||8.98|-0.99|0.116
71130791|NCT00988091|141765472|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.081|TWO_SIDED|95.0|0.483|1.044||For secondary outcome measures, fixed-sequence testing was used in a sequentially rejective fashion. The a priori threshold for statistical significance was p \<0.05.|Regression, Logistic|The analysis included study center as a stratification variable.||The null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.\[||1.044|0.483|0.081
70947060|NCT01121913|141394375|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LS means) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-t) is between 80% and 125%.|Mean ratio|97.7|||||TWO_SIDED|90.0|87.7|109.0|||||Trazodone Contramid® OAD (prototype 2)/Desyrel®|||109|87.7|
70947061|NCT01121913|141394376|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-∞) is between 80% and 125%.|Mean ratio|102.0|||||TWO_SIDED|90.0|91.8|114.0|||||Trazodone Contramid® OAD (prototype 1)/Triticco®|||114|91.8|
70947062|NCT01121913|141394376|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-∞) is between 80% and 125%.|Mean ratio|106.0|||||TWO_SIDED|90.0|95.1|118.0|||||Trazodone Contramid® OAD (prototype 1)/Desyrel®|||118|95.1|
71130792|NCT01846741|141765482|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 3 months||||0.008
71130793|NCT01846741|141765482|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 6 months||||0.040
71130794|NCT01846741|141765482|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 12 months||||0.033
71130795|NCT01846741|141765482|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 3 months||||0.500
71130796|NCT01846741|141765482|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 6 months||||0.750
71130797|NCT01846741|141765482|SUPERIORITY_OR_OTHER|||||||0.156|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 12 months||||0.156
71130798|NCT01846741|141765482|SUPERIORITY_OR_OTHER|||||||0.938|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 3 months||||0.938
71130799|NCT01846741|141765482|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 6 months||||0.250
71130800|NCT01846741|141765482|SUPERIORITY_OR_OTHER|||||||0.999|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 12 months||||0.999
71130801|NCT01846741|141765482|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 18 Months||||0.057
71130802|NCT01846741|141765482|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 18 Months||||0.031
71130803|NCT01846741|141765482|SUPERIORITY_OR_OTHER|||||||0.625|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 18 Months||||0.625
71130804|NCT01846741|141765483|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.0008
71130805|NCT01846741|141765483|SUPERIORITY_OR_OTHER|||||||0.0544|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizure Score||||0.0544
71130806|NCT01846741|141765483|SUPERIORITY_OR_OTHER|||||||0.0207|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.0207
71130807|NCT01846741|141765483|SUPERIORITY_OR_OTHER|||||||0.0163|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.0163
71130808|NCT01846741|141765483|SUPERIORITY_OR_OTHER|||||||0.0156|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.0156
71130809|NCT01846741|141765483|SUPERIORITY_OR_OTHER|||||||0.0742|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.0742
71130810|NCT01846741|141765483|SUPERIORITY_OR_OTHER|||||||0.0884|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.0884
71130811|NCT01846741|141765483|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.0007
71130812|NCT01846741|141765483|SUPERIORITY_OR_OTHER|||||||0.1173|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizure||||0.1173
71130813|NCT01846741|141765483|SUPERIORITY_OR_OTHER|||||||0.0214|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery||||0.0214
70947063|NCT01121913|141394376|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-∞) is between 80% and 125%.|Mean ratio|94.9|||||TWO_SIDED|90.0|85.1|106.0|||||Trazodone Contramid® OAD (prototype 2)/Triticco®|||106|85.1|
71130814|NCT01846741|141765483|SUPERIORITY_OR_OTHER|||||||0.0114|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity||||0.0114
71130815|NCT01846741|141765483|SUPERIORITY_OR_OTHER|||||||0.0078|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery||||0.0078
71130816|NCT01846741|141765483|SUPERIORITY_OR_OTHER|||||||0.0875|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery||||0.0875
71130817|NCT01846741|141765483|SUPERIORITY_OR_OTHER|||||||0.1526|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery||||0.1526
71130818|NCT01846741|141765483|SUPERIORITY_OR_OTHER|||||||0.0031|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.0031
71130819|NCT01846741|141765483|SUPERIORITY_OR_OTHER|||||||0.0828|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizure||||0.0828
71130820|NCT01846741|141765483|SUPERIORITY_OR_OTHER|||||||0.0092|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery||||0.0092
70947064|NCT01121913|141394376|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-∞) is between 80% and 125%.|Mean ratio|98.4|||||TWO_SIDED|90.0|88.3|110.0|||||Trazodone Contramid® OAD (prototype 2)/Desyrel®|||110|88.3|
71130821|NCT01846741|141765483|SUPERIORITY_OR_OTHER|||||||0.0096|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity||||0.0096
71130822|NCT01846741|141765483|SUPERIORITY_OR_OTHER|||||||0.0234|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery||||0.0234
71130823|NCT01846741|141765483|SUPERIORITY_OR_OTHER|||||||0.0284|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery||||0.0284
71130824|NCT01846741|141765483|SUPERIORITY_OR_OTHER|||||||0.0679|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery||||0.0679
71130825|NCT01846741|141765483|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.0003
71130826|NCT01846741|141765483|SUPERIORITY_OR_OTHER|||||||0.0728|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score||||0.0728
71130827|NCT01846741|141765483|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.0005
71130828|NCT01846741|141765483|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.0005
70947065|NCT01121913|141394377|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax is between 75% and 133%.|Mean ratio|73.3|||||TWO_SIDED|90.0|63.2|85.0|||||Trazodone Contramid® OAD (prototype 1)/Triticco®|||85|63.2|
71130829|NCT01846741|141765483|SUPERIORITY_OR_OTHER|||||||0.0078|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.0078
71130830|NCT01846741|141765483|SUPERIORITY_OR_OTHER|||||||0.0078|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.0078
70859997|NCT01315236|141206546|SUPERIORITY|||||||0.072||||||Conducted in the mITT population using a stratified Wilcoxon rank sum test, to compare the treatment arms at a 2-sided significance level of 0.05, adjusting for the randomization strata (presence/absence of CF and MAC versus Mycobacterium abscessus).|Wilcoxon rank sum test|||"The primary efficacy analysis tested the following hypotheses:~* H0: There is no difference at Day 84 between the LAI arm and the placebo arm~* Ha: There is a difference at Day 84 between the LAI arm and the placebo arm~Statistical analysis applies to all day 84 rows."||||0.072
70859998|NCT01315236|141206547|SUPERIORITY|||||||0.003|||||||Cochran-Mantel-Haenszel|||stratified Cochran-Mantel-Haenszel test||||0.003
70859999|NCT01315236|141206548|SUPERIORITY||Cox Proportional Hazard|5.68||||0.0129|TWO_SIDED|95.0|1.25|25.79|||Regression, Cox|||Cox proportional hazard model||25.79|1.25|0.0129
70860000|NCT01315236|141206549|SUPERIORITY|||||||0.077|||||||Regression, Logistic|||Ordinal Logistic Regressions Model||||0.077
70860001|NCT01315236|141206550|SUPERIORITY|||||||0.4545|||||||Wilcoxon (Mann-Whitney)|||Stratified Wilcoxon-rank sum||||0.4545
70860002|NCT01315236|141206552|SUPERIORITY||Cox Proportional Hazard|2.69||||0.0076|TWO_SIDED|95.0|1.28|5.64|||Regression, Cox|||Cox Proportional Hazard Model||5.64|1.28|0.0076
70947066|NCT01121913|141394377|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax is between 75% and 133%.|Mean ratio|59.8|||||TWO_SIDED|90.0|51.5|69.4|||||Trazodone Contramid® OAD (prototype 1)/Desyrel®|||69.4|51.5|
70860003|NCT02821910|141206572|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|96.7|STANDARD_DEVIATION|5.9|||TWO_SIDED|90.0|92.89|100.66|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||100.66|92.89|
70860004|NCT02821910|141206572|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|100.8|STANDARD_DEVIATION|4.8|||TWO_SIDED|90.0|97.99|103.7|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||103.70|97.99|
70860005|NCT02821910|141206572|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|99.83|STANDARD_DEVIATION|5.9|||TWO_SIDED|90.0|95.96|103.85|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||103.85|95.96|
70860006|NCT02821910|141206573|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|96.82|STANDARD_DEVIATION|9.7|||TWO_SIDED|90.0|90.65|103.42|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||103.42|90.65|
70860007|NCT02821910|141206573|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|95.67|STANDARD_DEVIATION|15.5|||TWO_SIDED|90.0|87.44|104.68|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.68|87.44|
70947067|NCT01121913|141394377|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax is between 75% and 133%.|Mean ratio|83.0|||||TWO_SIDED|90.0|71.5|96.4|||||Trazodone Contramid® OAD (prototype 2)/Triticco®|||96.4|71.5|
70947068|NCT01121913|141394377|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax is between 75% and 133%.|Mean ratio|67.7|||||TWO_SIDED|90.0|58.4|78.5|||||Trazodone Contramid® OAD (prototype 2)/Desyrel®|||78.5|58.4|
70860008|NCT02821910|141206573|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|98.47|STANDARD_DEVIATION|9.9|||TWO_SIDED|90.0|92.12|105.25|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||105.25|92.12|
70860009|NCT02821910|141206574|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|94.94|STANDARD_DEVIATION|13.8|||TWO_SIDED|90.0|86.6|104.08|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.08|86.60|
70947069|NCT04353817|141394416|SUPERIORITY||Least Squares (LS) Mean Difference|-2.26|||<|0.0001|TWO_SIDED|95.0|-2.71|-1.81|||Mixed-effects Model for Repeated Measure|||||-1.81|-2.71|<0.0001
71130831|NCT01846741|141765483|SUPERIORITY_OR_OTHER|||||||0.0273|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.0273
70860010|NCT02821910|141206574|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|106.63|STANDARD_DEVIATION|9.9|||TWO_SIDED|90.0|100.65|112.96|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||112.96|100.65|
70947070|NCT04353817|141394417|SUPERIORITY||LS Mean Difference|-51.2|||<|0.0001|TWO_SIDED|95.0|-55.3|-47.1||This is the nominal p-value without multiplicity controlled.|Mixed-effects Model for Repeated Measure|||||-47.1|-55.3|<0.0001
71130832|NCT01846741|141765484|SUPERIORITY_OR_OTHER|||||||0.0192|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total||||0.0192
71130833|NCT01846741|141765484|SUPERIORITY_OR_OTHER|||||||0.8069|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue||||0.8069
71130834|NCT01846741|141765484|SUPERIORITY_OR_OTHER|||||||0.2416|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being||||0.2416
71130835|NCT01846741|141765484|SUPERIORITY_OR_OTHER|||||||0.1111|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning||||0.1111
71130836|NCT01846741|141765484|SUPERIORITY_OR_OTHER|||||||0.0014|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning||||0.0014
71130837|NCT01846741|141765484|SUPERIORITY_OR_OTHER|||||||0.3247|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects||||0.3247
71130838|NCT01846741|141765484|SUPERIORITY_OR_OTHER|||||||0.0826|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry||||0.0826
71130839|NCT01846741|141765484|SUPERIORITY_OR_OTHER|||||||0.104|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life||||0.1040
71130840|NCT01846741|141765484|SUPERIORITY_OR_OTHER|||||||0.0094|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total||||0.0094
71130841|NCT01846741|141765484|SUPERIORITY_OR_OTHER|||||||0.5874|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue||||0.5874
71130842|NCT01846741|141765484|SUPERIORITY_OR_OTHER|||||||0.1508|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being||||0.1508
71130843|NCT01846741|141765484|SUPERIORITY_OR_OTHER|||||||0.0136|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning||||0.0136
71130844|NCT01846741|141765484|SUPERIORITY_OR_OTHER|||||||0.0015|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning||||0.0015
71130845|NCT01846741|141765484|SUPERIORITY_OR_OTHER|||||||0.3522|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects||||0.3522
71130846|NCT01846741|141765484|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry||||0.0240
71130847|NCT01846741|141765484|SUPERIORITY_OR_OTHER|||||||0.0353|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life||||0.0353
71130848|NCT01846741|141765484|SUPERIORITY_OR_OTHER|||||||0.0361|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total Score||||0.0361
71130849|NCT01846741|141765484|SUPERIORITY_OR_OTHER|||||||0.1921|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue||||0.1921
71130850|NCT01846741|141765484|SUPERIORITY_OR_OTHER|||||||0.1639|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being||||0.1639
71130851|NCT01846741|141765484|SUPERIORITY_OR_OTHER|||||||0.1738|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning||||0.1738
71130852|NCT01846741|141765484|SUPERIORITY_OR_OTHER|||||||0.0401|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning||||0.0401
71130853|NCT01846741|141765484|SUPERIORITY_OR_OTHER|||||||0.2753|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects||||0.2753
71130854|NCT01846741|141765484|SUPERIORITY_OR_OTHER|||||||0.0056|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry||||0.0056
70947071|NCT00002597|141394425|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.0309|TWO_SIDED|95.0|1.01|1.35|||Log Rank||Reference level = Hormone Therapy + Radiation Therapy|Null hypothesis: 8-year OS rate of 60% radiation therapy (RT) alone vs. 67% with hormone therapy. The study was designed with 90% power to detect a 7-percentage- point absolute difference in the 8-year survival rate, with the use of a one-sided log-rank test at the 0.025 significance level, requiring 1980 patients and 716 deaths for definitive analysis.||1.35|1.01|0.0309
70947072|NCT00002597|141394426|SUPERIORITY||Hazard Ratio (HR)|1.86||||0.001|TWO_SIDED|95.0|1.27|2.74|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.||2.74|1.27|0.001
70947073|NCT00002597|141394427|SUPERIORITY||Hazard Ratio (HR)|1.5||||0.0013|TWO_SIDED|95.0|1.17|1.93|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.||1.93|1.17|0.0013
70947074|NCT00002597|141394428|SUPERIORITY||Hazard Ratio (HR)|1.45||||0.035|TWO_SIDED|95.0|1.03|2.06|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.||2.06|1.03|0.035
70947075|NCT00002597|141394429|SUPERIORITY||Hazard Ratio (HR)|1.74|||<|0.001|TWO_SIDED|95.0|1.48|2.04|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.||2.04|1.48|<0.001
70947076|NCT00002597|141394430|SUPERIORITY||Hazard Ratio (HR)|1.5|||<|0.001|TWO_SIDED|95.0|1.21|1.85|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.||1.85|1.21|<0.001
70947077|NCT00002597|141394431|SUPERIORITY||Hazard Ratio (HR)|2.06|||<|0.001|TWO_SIDED|95.0|1.34|3.16|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.||3.16|1.34|<0.001
70947078|NCT00002597|141394432|SUPERIORITY||Hazard Ratio (HR)|1.38|||<|0.001|TWO_SIDED|95.0|1.22|1.56|||Log Rank||Reference level = Hormone Therapy + Radiation Therapy|Treatment arms were compared using the log-rank test (one-sided significance level of 0.025).||1.56|1.22|<0.001
70947079|NCT00002597|141394433|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
70947080|NCT02485899|141394462|OTHER||Hazard Ratio (HR)|0.14|||<|0.0001|TWO_SIDED|95.0|0.06|0.33|||Cox Proportional Hazards model|||||0.33|0.06|<0.0001
70947081|NCT02485899|141394463|OTHER||Hazard Ratio (HR)|0.01|||<|0.0001|TWO_SIDED||||||Cox Proportional Hazards model|||||||<0.0001
70947082|NCT02143063|141394504|SUPERIORITY||comparison of rank sum|3752.0||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.01
70947083|NCT02143063|141394504|SUPERIORITY||comparison of rank sum|5287.5||||0.78|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.78
71130855|NCT01846741|141765484|SUPERIORITY_OR_OTHER|||||||0.1173|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life||||0.1173
70947084|NCT02143063|141394505|SUPERIORITY||comparison of rank sum|3675.5||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Primary Aim 1: Compare the standard care and standard care plus traditional CM conditions||||.02
70947085|NCT02143063|141394505|SUPERIORITY||comparison of rank sum|5189.5||||0.61|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.61
70947086|NCT00623363|141394512|SUPERIORITY|||||||0.503|||||||Monte Carlo estimates|||Baseline (Day -7)||||0.503
70947087|NCT00623363|141394512|SUPERIORITY||Least Squares (LS) Mean|20.6|||||TWO_SIDED|95.0|1.82|39.37||||||Average of Days 1 and 2||39.37|1.82|
70947088|NCT00623363|141394512|SUPERIORITY||Least Squares (LS) Mean|3.6|||||TWO_SIDED|95.0|-15.18|22.37||||||Change from Baseline||22.37|-15.18|
70947089|NCT00623363|141394512|SUPERIORITY||Least Squares (LS) Mean|36.59|||||TWO_SIDED|95.0|24.04|49.14||||||Average of Days 1 and 2||49.14|24.04|
70947090|NCT00623363|141394512|SUPERIORITY||Least Squares (LS) Mean|19.59||||0.16|TWO_SIDED|95.0|7.04|32.14|||ANCOVA|||Change from Baseline||32.14|7.04|0.160
70947091|NCT00823836|141394538|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of ropinirole PR/XR tablets to ropinirole IR tablets was assessed with a non-inferiority margin of 2.5.|Median Difference (Net)|0.34||||0.702|TWO_SIDED|95.0|-1.41|2.09||Analysis of covariance (ANCOVA) model: value of change from Week 0 at Week 24 = treatment group + Week 0 value|ANCOVA|||||2.09|-1.41|0.702
70947092|NCT03713320|141394600|SUPERIORITY|||||||0.9539|||||||Cochran-Mantel-Haenszel|||Comparison of the treatment groups is based on a Cochran-Mantel-Haenzel test controlling for the number of tumors at screening (at least one tumor at screening versus no tumors at screening) and number of prognostic factors (0-1 versus 2 prognostic factors). Prognostic factors include age at diagnosis \> 60 years and lactate dehydrogenase level \> upper limit of normal at diagnosis. Number of subjects achieving ORR4 and exact binomial (Clopper-Pearson) confidence intervals are presented.||||.9539
71130856|NCT01846741|141765484|SUPERIORITY_OR_OTHER|||||||0.0268|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total||||0.0268
71130857|NCT01846741|141765484|SUPERIORITY_OR_OTHER|||||||0.4406|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final||||0.4406
71130858|NCT01846741|141765484|SUPERIORITY_OR_OTHER|||||||0.7926|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional Well Being Final||||0.7926
70947093|NCT03713320|141394601|SUPERIORITY|||||||0.011|||||||Regression, Cox|||Hazard ratio (cobomarsen/vorinostat) and p-value comparing the treatment groups is based on a Cox proportional hazards model. A hazard ratio \< 1 favors cobomarsen over vorinostat.||||0.011
70947094|NCT02271230|141394615|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.78|1.11||||||||1.11|0.78|
70947095|NCT02271230|141394615|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.8|1.14||||||||1.14|0.80|
70947096|NCT02271230|141394616|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.81|1.09||||||||1.09|0.81|
70947097|NCT02271230|141394616|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.74|0.998||||||||0.998|0.74|
70860011|NCT02821910|141206574|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|100.41|STANDARD_DEVIATION|8.9|||TWO_SIDED|90.0|94.54|106.64|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||106.64|94.54|
70860012|NCT02821910|141206575|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|97.97|STANDARD_DEVIATION|10.2|||TWO_SIDED|90.0|91.46|104.94|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.94|91.46|
70860013|NCT02821910|141206575|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|100.04|STANDARD_DEVIATION|17.9|||TWO_SIDED|90.0|90.23|110.91|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||110.91|90.23|
70860014|NCT02821910|141206575|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|101.24|STANDARD_DEVIATION|10.1|||TWO_SIDED|90.0|94.58|108.38|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||108.38|94.58|
70860015|NCT02821910|141206576|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|97.5|STANDARD_DEVIATION|12.0|||TWO_SIDED|90.0|89.94|105.71|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||105.71|89.94|
70860016|NCT02821910|141206576|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|117.31|STANDARD_DEVIATION|22.0|||TWO_SIDED|90.0|103.41|133.07|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||133.07|103.41|
70860017|NCT02821910|141206576|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|102.74|STANDARD_DEVIATION|6.2|||TWO_SIDED|90.0|98.56|107.1|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||107.10|98.56|
70860018|NCT02821910|141206577|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|96.34|STANDARD_DEVIATION|6.6|||TWO_SIDED|90.0|92.13|100.75|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||100.75|92.13|
70860019|NCT02821910|141206577|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|105.07|STANDARD_DEVIATION|8.6|||TWO_SIDED|90.0|99.95|110.45|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||110.45|99.95|
70860020|NCT02821910|141206577|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|100.31|STANDARD_DEVIATION|5.9|||TWO_SIDED|90.0|96.41|104.38|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.38|96.41|
70860021|NCT02821910|141206578|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|96.63|STANDARD_DEVIATION|5.8|||TWO_SIDED|90.0|92.86|100.54|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||100.54|92.86|
71130859|NCT01846741|141765484|SUPERIORITY_OR_OTHER|||||||0.0987|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final||||0.0987
70947098|NCT03042299|141394624|EQUIVALENCE|The difference in the least square (LS) means between formulations (TAK-536 pediatric formulation \[granules\]-TAK-536 commercial formulation \[tablet\]) and the two-sided 90 percent (%) confidence interval (CI) were provided using a crossover analysis of variance (ANOVA) model. The ANOVA model included log-transformed (natural log) PK parameters AUC 48 as dependent variable, and formulation, group, and period as independent variables.|Point estimate|-0.0731|||||TWO_SIDED|90.0|-0.1088|-0.0373||||||||-0.0373|-0.1088|
70947099|NCT03042299|141394625|EQUIVALENCE|The difference in the LS means between formulations (TAK-536 pediatric formulation \[granules\]-TAK-536 commercial formulation \[tablet\]) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters Cmax as dependent variable, and formulation, group, and period as independent variables.|Point estimate|-0.0909|||||TWO_SIDED|90.0|-0.1573|-0.0244||||||||-0.0244|-0.1573|
70947100|NCT01438840|141394635|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
70947101|NCT02804399|141394646|SUPERIORITY_OR_OTHER||Ratio of Geometric Mean|14.74|||||TWO_SIDED|90.0|12.78|17.01||||||Mixed model was fitted to obtain ratio of geometric means of Rifampin 600 mg QD + PF-06463922 100 mg SD (test) to PF-06463922 100 mg SD (reference) and the results are presented as percentage. 90% CI was calculated on ratio of geometric means.||17.01|12.78|
71130860|NCT01846741|141765484|SUPERIORITY_OR_OTHER|||||||0.0361|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning Final||||0.0361
71130861|NCT01846741|141765484|SUPERIORITY_OR_OTHER|||||||0.0615|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects Final||||0.0615
71130862|NCT01846741|141765484|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry||||0.0024
71130863|NCT01846741|141765484|SUPERIORITY_OR_OTHER|||||||0.0155|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life||||0.0155
71130864|NCT01846741|141765486|SUPERIORITY_OR_OTHER|||||||0.0625|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||3 months||||0.0625
71130865|NCT01846741|141765486|SUPERIORITY_OR_OTHER|||||||0.1094|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||6 months||||0.1094
71130866|NCT01846741|141765486|SUPERIORITY_OR_OTHER|||||||0.0342|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||12 months||||0.0342
71130867|NCT01846741|141765486|SUPERIORITY_OR_OTHER|||||||0.5417|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||18 Months||||0.5417
71130868|NCT01817959|141765514|SUPERIORITY||least square mean difference|0.001||||0.9863|TWO_SIDED|99.75|-0.205|0.207||Treatment p value|ANOVA|||||0.207|-0.205|0.9863
71130869|NCT01817959|141765515|SUPERIORITY||least square mean difference|0.024||||0.7115|TWO_SIDED|99.75|-0.184|0.232||Treatment p value|ANOVA|||||0.232|-0.184|0.7115
71130870|NCT01817959|141765516|SUPERIORITY||Odds Ratio, log|0.21||||0.1346|TWO_SIDED|95.0|0.03|1.63||Treatment p value|Regression, Logistic|||Analytical statistics are reported for Day 75 after transplant 2||1.63|0.03|0.1346
71130871|NCT01817959|141765517|SUPERIORITY||Odds Ratio (OR)|0.91||||0.913|TWO_SIDED|95.0|0.17|4.93||Treatment p value|Regression, Logistic|||||4.93|0.17|0.9130
71130872|NCT01817959|141765518|SUPERIORITY||Odds Ratio (OR)|0.65||||0.5467|TWO_SIDED|95.0|0.16|2.66||Treatment p value|Regression, Logistic|||||2.66|0.16|0.5467
71130873|NCT01817959|141765519|SUPERIORITY|||||||0.1383|||||||Fisher Exact|||||||0.1383
71130874|NCT01817959|141765521|SUPERIORITY||least square mean difference|-0.021||||0.6952|TWO_SIDED|95.0|-0.13|0.088||Treatment p value|ANCOVA|||This is is the analytic statistics for Day 75 (Transplant 1)||0.088|-0.130|0.6952
71130875|NCT01817959|141765521|SUPERIORITY||least square mean difference|0.028||||0.556|TWO_SIDED|95.0|-0.068|0.124||This is a treatment p value|ANCOVA|||This is is the analytic statistics for Day 75 (Transplant 2)||0.124|-0.068|0.5560
71130876|NCT01817959|141765521|SUPERIORITY||least square mean difference|0.056||||0.2537|TWO_SIDED|95.0|-0.042|0.154||Treatment p value|ANCOVA|Treatment p value||This is the analytic statics for Day 365 (last Transplant)||0.154|-0.042|0.2537
71130877|NCT01817959|141765522|SUPERIORITY||least square mean difference|-7.4||||0.591|TWO_SIDED|95.0|-35.2|20.3||Treatment p value|ANCOVA|||This is the analytic statics for Day 75 (Transplant 1)||20.3|-35.2|0.5910
71130878|NCT01817959|141765522|SUPERIORITY||least square mean difference|4.2||||0.5966|TWO_SIDED|95.0|-11.8|20.2||Treatment p value|ANCOVA|Treatment p value||This is the analytic statics for Day 75 (Transplant 2)||20.2|-11.8|0.5966
71130879|NCT01817959|141765522|SUPERIORITY||least square mean difference|6.1||||0.5005|TWO_SIDED|95.0|-12.1|24.4||Treatment p value|ANCOVA|||This is the analytic statics for Day 365 (last Transplant)||24.4|-12.1|0.5005
71130880|NCT01817959|141765523|SUPERIORITY||least square mean difference|0.21||||0.3253|TWO_SIDED|95.0|-0.21|0.63||Treatment p value|ANCOVA|||This is the analytic statics for Day 75 (Transplant 1)||0.63|-0.21|0.3253
70860022|NCT02821910|141206578|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|100.87|STANDARD_DEVIATION|5.0|||TWO_SIDED|90.0|97.96|103.86|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||103.86|97.96|
70947102|NCT02804399|141394647|SUPERIORITY_OR_OTHER||Ratio of Geometric Mean|23.88|||||TWO_SIDED|90.0|21.58|26.43||||||Mixed model was fitted to obtain ratio of geometric means of Rifampin 600 mg QD + PF-06463922 100 mg SD (test) to PF-06463922 100 mg SD (reference) and the results are presented as percentage. 90% CI was calculated on ratio of geometric means.||26.43|21.58|
70860023|NCT02821910|141206578|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|99.75|STANDARD_DEVIATION|6.0|||TWO_SIDED|90.0|95.81|103.86|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||103.86|95.81|
70860024|NCT02821910|141206579|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|96.57|STANDARD_DEVIATION|8.9|||TWO_SIDED|90.0|90.94|102.56|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||102.56|90.94|
70860025|NCT02821910|141206579|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|95.4|STANDARD_DEVIATION|14.9|||TWO_SIDED|90.0|87.5|104.01|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.01|87.50|
70860026|NCT02821910|141206579|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|98.45|STANDARD_DEVIATION|9.4|||TWO_SIDED|90.0|92.44|104.85|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.85|92.44|
70860027|NCT02821910|141206580|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|95.08|STANDARD_DEVIATION|12.6|||TWO_SIDED|90.0|87.36|103.48|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||103.48|87.36|
70860028|NCT02821910|141206580|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|105.72|STANDARD_DEVIATION|11.7|||TWO_SIDED|90.0|98.78|113.15|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||113.15|98.78|
70860029|NCT02821910|141206580|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|101.61|STANDARD_DEVIATION|14.9|||TWO_SIDED|90.0|92.0|112.22|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||112.22|92.00|
70860030|NCT04218123|141206584|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||<|0.001|||||||ANOVA|||||||<0.001
70860031|NCT04218123|141206584|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent|||||<|0.05|||||||ANOVA|Anova Post Hoc Analysis||||||<0.05
70860032|NCT04218123|141206584|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent|||||<|0.05|||||||ANOVA|Anova Post Hoc Analysis||||||<0.05
70860033|NCT04218123|141206584|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent|||||>|0.05|||||||ANOVA|Anova Post Hoc Analysis||||||>0.05
70860034|NCT04218123|141206586|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||=|0.31|||||||ANOVA|||SF20 Physical Functioning||||=0.31
70860035|NCT04218123|141206586|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent||||||0.633|||||||ANOVA|||SF20 Role Functioning||||0.633
70860036|NCT04218123|141206586|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent||||||0.424|||||||ANOVA|||SF20 Mental Health||||0.424
70860037|NCT04218123|141206586|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent||||||0.057|||||||ANOVA|||SF20 Social Functioning||||0.057
70860038|NCT04218123|141206586|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent||||||0.296|||||||ANOVA|||SF20 Health Perceptions||||0.296
70860039|NCT04218123|141206586|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent||||||0.872|||||||ANOVA|||SF20 Pain||||0.872
70860040|NCT04218123|141206587|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||=|0.538|||||||ANOVA|||||||=0.538
70860041|NCT04218123|141206588|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||=|0.686|||||||ANOVA|||||||=0.686
70860042|NCT04218123|141206589|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||=|0.167|||||||ANOVA|||||||=0.167
70860043|NCT04218123|141206590|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||=|0.8|||||||ANOVA|||||||=0.8
70860044|NCT04218123|141206591|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||=|0.425|||||||ANOVA|||||||=0.425
70860045|NCT04218123|141206592|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent.|||||=|0.054|||||||ANOVA|||||||=0.054
71130881|NCT01817959|141765523|SUPERIORITY||least square mean difference|0.16||||0.6069|TWO_SIDED|95.0|-0.46|0.78||Treatment p value|least square mean difference|||This is the analytic statics for Day 75 (Transplant 2)||0.78|-0.46|0.6069
71130882|NCT01817959|141765523|SUPERIORITY||Least square mean difference|0.17||||0.6437|TWO_SIDED|95.0|-0.56|0.93||Treatment p value|ANCOVA|Treatment p value||This is the analytic statics for Day 365 (last Transplant)||0.93|-0.56|0.6437
71130883|NCT01817959|141765524|SUPERIORITY||least square mean difference|2.0||||0.429|TWO_SIDED|95.0|-3.0|6.9||Treatment p value|ANCOVA|||This is the analytic statistics for Day 75 (Transplant 1)||6.9|-3.0|0.4290
71130884|NCT01817959|141765524|SUPERIORITY||least square mean difference|1.0||||0.7853|TWO_SIDED|95.0|-6.3|8.3||Treatment p value|ANCOVA|||This is the analytic statistics for Day 75 (Transplant 2)||8.3|-6.3|0.7853
71130885|NCT01817959|141765524|SUPERIORITY||least square mean difference|1.9||||0.6583|TWO_SIDED|95.0|-6.6|10.4||Treatment p value|ANCOVA|||This is the analytic statistics for Day 365 (last Transplant)||10.4|-6.6|0.6583
71130886|NCT01817959|141765528|SUPERIORITY||Least square mean difference|0.0||||0.9949|TWO_SIDED|95.0|-1.28|1.28||Treatment p value|ANOVA|||This is the analytic statistics for Day 75 (Transplant 1)||1.28|-1.28|0.9949
71130887|NCT01817959|141765528|SUPERIORITY||Least square mean difference|0.1||||0.8753|TWO_SIDED|95.0|-1.18|1.38||Treatment p value|ANOVA|||This is the analytic statistics for Day 75 (Transplant 2)||1.38|-1.18|0.8753
71130888|NCT01817959|141765528|SUPERIORITY||Least square mean difference|-0.59||||0.3955|TWO_SIDED|95.0|-1.97|0.8||Treatment p value|ANOVA|||This is the analytic statistics for Day 365 (last Transplant)||0.80|-1.97|0.3955
71130889|NCT01817959|141765529|SUPERIORITY||Least square mean difference|-0.105||||0.2444|TWO_SIDED|95.0|-0.286|0.075||Treatment p value|ANOVA|||This is the analytic statistics for Day 75 (Transplant 1)||0.075|-0.286|0.2444
71130890|NCT01817959|141765529|SUPERIORITY||Least square mean difference|-0.218||||0.0328|TWO_SIDED|95.0|-0.417|-0.019||Treatment p value|ANOVA|||This is the analytic statistics for Day 75 (Transplant 2)||-0.019|-0.417|0.0328
71130891|NCT01817959|141765529|SUPERIORITY||Least square mean difference|-0.177||||0.1059|TWO_SIDED|95.0|-0.393|0.039||This is the analytic statistics for Day 75 (Transplant 2)|ANOVA|||This is the analytic statistics for Day 365 (last Transplant)||0.039|-0.393|0.1059
71130892|NCT02578186|141765559|SUPERIORITY_OR_OTHER|||||||0.0312|||||||ANCOVA|||||||0.0312
71130893|NCT03216746|141765571|OTHER|||||||0.001|||||||Kruskal-Wallis|||||||0.001
71130894|NCT02980133|141765592|SUPERIORITY||LS mean difference|1.9||||0.285|TWO_SIDED|95.0|-1.6|5.3||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using an ANCOVA model with effects due to baseline trough morning percent predicted FEV1, sex, age, (pooled) investigational center, previous therapy (ICS or NCS), and IMP treatment group.||5.3|-1.6|0.285
71130895|NCT02980133|141765593|SUPERIORITY||Least square (LS) mean difference|6.0|||<|0.001|TWO_SIDED|95.0|3.2|8.8||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using an analysis of covariance (ANCOVA) model with effects due to baseline trough morning percent predicted FEV1, sex, age, (pooled) investigational center, previous therapy (inhaled corticosteroid \[ICS\] or noncorticosteroid \[NCS\]), and investigational medicinal product (IMP) treatment group.||8.8|3.2|<0.001
71130896|NCT02980133|141765593|SUPERIORITY||LS mean difference|7.0|||<|0.001|TWO_SIDED|95.0|4.1|9.8||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using an ANCOVA model with effects due to baseline trough morning percent predicted FEV1, sex, age, (pooled) investigational center, previous therapy (ICS or NCS), and IMP treatment group.||9.8|4.1|<0.001
71130897|NCT01278797|141765623|SUPERIORITY_OR_OTHER||Test/Reference ratio of geometric means|94.51||||0.005||90.0|91.6|97.51|||ANOVA|ANOVA was applied to log-transformed AUC72 and Included treatment, sequence, period and subject-within-sequence effects.||Telmisartan/Amlodipine 80 mg/10 mg versus Telmisartan 80 mg + Amlodipine 10 mg The two formulations are shown to be bioequivalent since the 90% confidence interval of the test to reference ratio is entirely contained within the 80-125% bioequivalence range.||97.51|91.60|0.005
71130898|NCT01278797|141765624|SUPERIORITY_OR_OTHER||Test/Reference ratio of geometric means|94.1||||0.0093||90.0|90.7|97.63|||ANOVA|ANOVA was applied to log-transformed CMAX and Included treatment, sequence, period and subject-within-sequence effects.||Telmisartan/Amlodipine 80 mg/10 mg versus Telmisartan 80 mg + Amlodipine 10 mg The two formulations are shown to be bioequivalent since the 90% confidence interval of the test to reference ratio is entirely contained within the 80-125% bioequivalence range.||97.63|90.70|0.0093
71130899|NCT01278797|141765625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58||||0.153|||||||ANOVA|ANOVA was applied to TMAX and Included treatment, sequence, period and subject-within-sequence effects.||Telmisartan/Amlodipine 80 mg/10 mg versus Telmisartan 80 mg + Amlodipine 10 mg||||0.153
71130900|NCT03188510|141765628|OTHER||Ratio of geometric least squares means|0.971|||||TWO_SIDED|90.0|0.805|1.17||||||||1.17|0.805|
71130901|NCT03188510|141765628|OTHER||Ratio of geometric least squares means|1.01|||||TWO_SIDED|90.0|0.841|1.22||||||||1.22|0.841|
71130902|NCT03188510|141765628|OTHER||Ratio of geometric least squares means|0.985|||||TWO_SIDED|90.0|0.819|1.18||||||||1.18|0.819|
71130903|NCT03188510|141765629|OTHER||Ratio of geometric least squares means|0.978|||||TWO_SIDED|90.0|0.811|1.18||||||||1.18|0.811|
71130904|NCT03188510|141765629|OTHER||Ratio of geometric least squares means|1.0|||||TWO_SIDED|90.0|0.833|1.21||||||||1.21|0.833|
71130905|NCT03188510|141765629|OTHER||Ratio of geometric least squares means|0.982|||||TWO_SIDED|90.0|0.817|1.18||||||||1.18|0.817|
71130906|NCT03052049|141765633|OTHER|t-test|p value|0.05||||0.05|TWO_SIDED|0.0||||P value was calculated with threshold of significance \<0.05.|t-test, 2 sided||P value was calculated with threshold of significance \<0.05.|||||0.05
71130907|NCT03052049|141765634|OTHER|||||||0.05||||||P value was calculated and a value of \<0.05 was considered significant.|t-test, 2 sided|||||||0.05
71130908|NCT03052049|141765635|OTHER|||||||0.05||||||P value was calculated and a value of \<0.05 was considered significant.|t-test, 2 sided|||||||0.05
71130909|NCT03052049|141765636|OTHER|||||||0.05||||||P value was calculated and a value of \<0.05 was considered significant.|t-test, 2 sided|||||||0.05
71130910|NCT03052049|141765637|SUPERIORITY|||||||0.05||||||P value was calculated and a value of \<0.05 was considered significant.|t-test, 2 sided|||||||0.05
71130911|NCT04254666|141765642|OTHER||||||||||||||||||pre and post scores for this measure are presented as the percent of foods correctly classified.|||
71130912|NCT00826618|141765724|SUPERIORITY_OR_OTHER|||||||0.0015|||||||t-test, 2 sided|||Compare final visual acuity to baseline visual acuity||||0.0015
71130913|NCT00931606|141765735|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
70860046|NCT01082640|141206593|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.134||0.459|TWO_SIDED|95.0|-0.37|0.17||No adjustment for multiplicity was made.|ANCOVA|The model included treatment as a factor, and the baseline value and prior use of an ARB or an ACEi or none as covariates.||All statistical tests were two sided and conducted at the 0.05 significance level.||0.17|-0.37|0.459
70947103|NCT02804399|141394648|SUPERIORITY_OR_OTHER||Ratio of Geometric Mean|13.96|||||TWO_SIDED|90.0|12.09|16.12||||||Mixed model was fitted to obtain ratio of geometric means of Rifampin 600 mg QD + PF-06463922 100 mg SD (test) to PF-06463922 100 mg SD (reference) and the results are presented as percentage. 90% CI was calculated on ratio of geometric means.||16.12|12.09|
71130914|NCT00931606|141765735|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
71130915|NCT00931606|141765735|SUPERIORITY|||||||0.524|||||||Fisher Exact|Clopper and Pearson exact approach||Overall||||0.524
71130916|NCT00931606|141765735|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
71130917|NCT00931606|141765735|SUPERIORITY|||||||0.333|||||||Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||0.333
71130918|NCT00931606|141765735|SUPERIORITY|||||||0.333|||||||Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||0.333
71130919|NCT00931606|141765735|SUPERIORITY|||||||0.333|||||||Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||0.333
71130920|NCT00931606|141765735|SUPERIORITY|||||||0.236|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.236
71130921|NCT00931606|141765735|SUPERIORITY|||||||0.429|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.429
71130922|NCT00931606|141765735|SUPERIORITY|||||||0.519|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.519
71130923|NCT00931606|141765738|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
71130924|NCT00931606|141765738|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
71130925|NCT00931606|141765738|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||>0.999
71130926|NCT00931606|141765738|SUPERIORITY||||||>|0.999|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||>0.999
71130927|NCT00931606|141765739|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999, are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
71130928|NCT00931606|141765739|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
71130929|NCT00931606|141765739|SUPERIORITY|||||||0.206|||||||Fisher Exact|Clopper and Pearson exact approach||Overall||||0.206
71130930|NCT00931606|141765739|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
71130931|NCT00931606|141765739|SUPERIORITY|||||||0.333|||||||Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||0.333
71130932|NCT00931606|141765739|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999, are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||>0.999
71130933|NCT00931606|141765739|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999, are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||>0.999
71130934|NCT00931606|141765739|SUPERIORITY|||||||0.429|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.429
71130935|NCT00931606|141765739|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||>0.999
71130936|NCT00931606|141765739|SUPERIORITY|||||||0.143|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.143
71130937|NCT00931606|141765739|SUPERIORITY|||||||0.519|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.519
71130938|NCT00931606|141765740|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
71130939|NCT00931606|141765740|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
71130940|NCT00931606|141765740|SUPERIORITY|||||||0.206|||||||Fisher Exact|Clopper and Pearson exact approach||Overall||||0.206
71130941|NCT00931606|141765740|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
71130942|NCT00931606|141765740|SUPERIORITY|||||||0.333|||||||Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||0.333
71130943|NCT00931606|141765740|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||>0.999
71130944|NCT00931606|141765740|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||>0.999
71130945|NCT00931606|141765740|SUPERIORITY|||||||0.429|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.429
71130946|NCT00931606|141765740|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||>0.999
71130947|NCT00931606|141765740|SUPERIORITY|||||||0.143|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.143
71130948|NCT00931606|141765740|SUPERIORITY|||||||0.519|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.519
71130949|NCT02170870|141765763|SUPERIORITY|||||||0.06|||||||ANOVA|||Mean GI symptom score during lipid infusion in controls vs diabetics adjusted for treatment status (ie, exendin or placebo)||||0.06
71130950|NCT02170870|141765763|SUPERIORITY|||||||0.0001|||||||ANOVA|||Mean GI symptom score during lipid infusion in controls vs functional dyspepsia adjusted for treatment status (ie, exendin or placebo)||||0.0001
70860047|NCT01082640|141206593|SUPERIORITY_OR_OTHER||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.133||0.789|TWO_SIDED|95.0|-0.23|0.3||No adjustment for multiplicity was made.|ANCOVA|The model included treatment as a factor, and the baseline value and prior use of an ARB or an ACEi or none as covariates.||All statistical tests were two sided and conducted at the 0.05 significance level.||0.30|-0.23|0.789
70860048|NCT01082640|141206594|SUPERIORITY_OR_OTHER||LS mean difference|2.38|STANDARD_ERROR_OF_MEAN|1.687||0.162|TWO_SIDED|95.0|-0.97|5.73||No adjustment for multiplicity was made.|ANCOVA|The model included treatment as a factor, and the baseline value and prior use of an ARB or an ACEi or none as covariates.||||5.73|-0.97|0.162
70860049|NCT01082640|141206594|SUPERIORITY_OR_OTHER||LS mean difference|1.19|STANDARD_ERROR_OF_MEAN|1.698||0.485|TWO_SIDED|95.0|-2.18|4.57||No adjustment for multiplicity was made.|ANCOVA|The model included treatment as a factor, and the baseline value and prior use of an ARB or an ACEi or none as covariates.||||4.57|-2.18|0.485
70860050|NCT01082640|141206595|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Prior use of an ARB, ACEi, or none was a stratification variable.||||||<0.001
70860051|NCT01082640|141206595|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Prior use of an ARB, ACEi, or none was a stratification variable.||||||<0.001
70860052|NCT01082640|141206595|SUPERIORITY_OR_OTHER|||||||0.062|||||||Cochran-Mantel-Haenszel|Prior use of an ARB, ACEi, or none was a stratification variable.||||||0.062
70860053|NCT03577171|141206599|OTHER||LS Mean Difference|-1.154||||0.0077|TWO_SIDED|95.0|-1.986|-0.322|||Repeated measures analysis|||Least Squares (LS) Mean Difference ABI-H0731 + SOC ETV minus Placebo + SOC ETV at Week 12||-0.322|-1.986|0.0077
70860054|NCT03577171|141206599|OTHER||LS Mean Difference|-1.141||||0.0084|TWO_SIDED|95.0|-1.973|-0.309|||Repeated measures analysis|||Least Squares Mean Difference ABI-H0731 + SOC ETV minus Placebo + SOC ETV at Week 24||-0.309|-1.973|0.0084
70860055|NCT02129777|141206669|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.008||||0.925|TWO_SIDED|95.0|-0.162|0.179|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Cochran-Mantel-Haenszel (CMH) P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.179|-0.162|0.925
70860056|NCT02129777|141206669|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.087||||0.162|TWO_SIDED|95.0|-0.202|0.028|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.028|-0.202|0.162
70860057|NCT02129777|141206669|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.034||||0.671|TWO_SIDED|95.0|-0.187|0.118|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.118|-0.187|0.671
70860058|NCT02129777|141206669|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.087||||0.182|TWO_SIDED|95.0|-0.202|0.028|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.028|-0.202|0.182
70860059|NCT02129777|141206671|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|1.75||0.435|TWO_SIDED|95.0|-2.1|4.9|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure.||4.9|-2.1|0.435
70860060|NCT02129777|141206671|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|1.74||0.279|TWO_SIDED|95.0|-1.6|5.4|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure.||5.4|-1.6|0.279
70860061|NCT02129777|141206671|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|1.74||0.085|TWO_SIDED|95.0|-0.4|6.5|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure.||6.5|-0.4|0.085
70860062|NCT02129777|141206671|SUPERIORITY_OR_OTHER||LS Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|1.76||0.11|TWO_SIDED|95.0|-0.7|6.3|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure.||6.3|-0.7|0.110
70860063|NCT02129777|141206672|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.027||||0.827|TWO_SIDED|95.0|-0.265|0.211|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.211|-0.265|0.827
70947104|NCT04211389|141394669|SUPERIORITY||Odds Ratio (OR)|6.59|||<|0.0001|TWO_SIDED|95.0|3.17|13.7||Stratification by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Cochran-Mantel-Haenszel||Common OR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|IGA Success at Week 8 Odds Ratio||13.70|3.17|<0.0001
70947105|NCT04211389|141394670|SUPERIORITY||Hazard Ratio (HR)|4.207|||<|0.0001|TWO_SIDED|95.0|3.029|5.844|||Log Rank|Unstratified log-rank test|HR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization.|Time to Achieve PASI-50||5.844|3.029|<0.0001
70947106|NCT04211389|141394671|SUPERIORITY||Odds Ratio (OR)|10.42|||<|0.0001|TWO_SIDED|95.0|4.49|24.19|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common OR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|PASI-75 at Week 8 Odds Ratio||24.19|4.49|<0.0001
71130951|NCT00125957|141765784|SUPERIORITY_OR_OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference in the mean change MADRS score between Wellbutrin-Placebo and Placebo-Wellbutrin treatment groups||||.04
70860064|NCT02129777|141206672|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.036||||0.768|TWO_SIDED|95.0|-0.269|0.198|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.198|-0.269|0.768
71130952|NCT00125957|141765785|SUPERIORITY_OR_OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference in the median HAM-D score between Wellbutrin-Placebo and Placebo-Wellbutrin treatment groups||||0.09
71130953|NCT02391363|141765786|SUPERIORITY|||||||0.77||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.08 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month PSWQ-A, controlling for baseline PSWQ-A.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate of .05."||||0.77
71130954|NCT02391363|141765787|SUPERIORITY|||||||0.07||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 3.50 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month PSWQ-A, controlling for baseline PSWQ-A.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.07
71130955|NCT02391363|141765788|SUPERIORITY|||||||0.34||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.92. (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month GAD-7, controlling for baseline GAD-7.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.34
71130956|NCT02391363|141765789|SUPERIORITY|||||||0.08||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 3.20 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month GAD-7, controlling for baseline GAD-7.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.08
71130957|NCT02391363|141765790|SUPERIORITY|||||||0.45||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.59 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month GAI-SF, controlling for baseline GAI-SF.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.45
71130958|NCT02391363|141765791|SUPERIORITY|||||||0.13||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 2.37 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month GAI-SF, controlling for baseline GAI-SF.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.13
71130959|NCT02391363|141765792|SUPERIORITY|||||||0.52||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.42 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month PHQ-8, controlling for baseline PHQ-8.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.52
70860065|NCT02129777|141206672|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.112||||0.338|TWO_SIDED|95.0|-0.33|0.106|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.106|-0.330|0.338
70860066|NCT02129777|141206672|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.017||||0.89|TWO_SIDED|95.0|-0.261|0.226|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.226|-0.261|0.890
70860067|NCT02129777|141206673|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.048||||0.295|TWO_SIDED|95.0|-0.043|0.139|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12:CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.139|-0.043|0.295
70860068|NCT02129777|141206674|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.012||||0.906|TWO_SIDED|95.0|-0.191|0.216|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and sPGA response category controlling for visit.||0.216|-0.191|0.906
70860069|NCT02129777|141206674|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.04||||0.677|TWO_SIDED|95.0|-0.222|0.143|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and sPGA response category controlling for visit.||0.143|-0.222|0.677
70860070|NCT02129777|141206674|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.13||||0.107|TWO_SIDED|95.0|-0.268|0.007|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and sPGA response category controlling for visit.||0.007|-0.268|0.107
70860071|NCT02129777|141206674|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.08||||0.371|TWO_SIDED|95.0|-0.248|0.087|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and sPGA response category controlling for visit.||0.087|-0.248|0.371
71130960|NCT02391363|141765793|SUPERIORITY|||||||0.29||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 1.14 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month PHQ-8, controlling for baseline PHQ-8.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.29
70860072|NCT02129777|141206675|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.095||||0.134|TWO_SIDED|95.0|-0.03|0.221|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and sPGA response category controlling for visit.||0.221|-0.030|0.134
70860073|NCT02129777|141206676|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.258|TWO_SIDED|95.0|-0.6|0.2|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an analysis of variance (ANOVA) model with terms for treatment and study site.||0.2|-0.6|0.258
70860074|NCT02129777|141206676|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.365|TWO_SIDED|95.0|-0.5|0.2|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.2|-0.5|0.365
70860075|NCT02129777|141206676|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.18||0.757|TWO_SIDED|95.0|-0.3|0.4|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.4|-0.3|0.757
70860076|NCT02129777|141206676|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.18||0.825|TWO_SIDED|95.0|-0.4|0.3|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.3|-0.4|0.825
70860077|NCT02129777|141206677|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|2.163||0.931|TWO_SIDED|95.0|-4.48|4.1|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||4.10|-4.48|0.931
70860078|NCT02129777|141206677|SUPERIORITY_OR_OTHER||LS Mean Difference|1.59|STANDARD_ERROR_OF_MEAN|2.143||0.459|TWO_SIDED|95.0|-2.65|5.84|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||5.84|-2.65|0.459
70860079|NCT02129777|141206677|SUPERIORITY_OR_OTHER||LS Mean Difference|3.65|STANDARD_ERROR_OF_MEAN|2.161||0.094|TWO_SIDED|95.0|-0.63|7.93|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||7.93|-0.63|0.094
70860080|NCT02129777|141206677|SUPERIORITY_OR_OTHER||LS Mean Difference|2.78|STANDARD_ERROR_OF_MEAN|2.173||0.203|TWO_SIDED|95.0|-1.52|7.09|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||7.09|-1.52|0.203
70860081|NCT02129777|141206678|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.7||0.448|TWO_SIDED|95.0|-1.92|0.86|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.86|-1.92|0.448
70860082|NCT02129777|141206678|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.692||0.099|TWO_SIDED|95.0|-2.53|0.22|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.22|-2.53|0.099
70860083|NCT02129777|141206678|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.69||0.396|TWO_SIDED|95.0|-1.96|0.78|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.78|-1.96|0.396
70860084|NCT02129777|141206678|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.697||0.102|TWO_SIDED|95.0|-2.54|0.23|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.23|-2.54|0.102
70860085|NCT02129777|141206679|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.626||0.099|TWO_SIDED|95.0|-2.29|-0.2|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||-0.20|-2.29|0.099
70860086|NCT02129777|141206679|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.619||0.045|TWO_SIDED|95.0|-2.49|-0.03|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||-0.03|-2.49|0.045
70860087|NCT02129777|141206679|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.62||0.118|TWO_SIDED|95.0|-2.21|0.25|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.25|-2.21|0.118
70860088|NCT02129777|141206679|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.22|STANDARD_ERROR_OF_MEAN|0.616||0.05|TWO_SIDED|95.0|-2.44|0.0|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.00|-2.44|0.050
70947107|NCT04211389|141394672|SUPERIORITY||Odds Ratio (OR)|8.51||||0.0002|TWO_SIDED|95.0|2.45|28.86|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common OR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|PASI-90 at Week 8 Odds Ratio||28.86|2.45|0.0002
71130961|NCT02391363|141765794|SUPERIORITY|||||||0.14||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 2.19 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month GDS-SF, controlling for baseline GDS-SF.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.14
70947108|NCT04211389|141394673|SUPERIORITY||Odds Ratio (OR)|11.18||||0.0004|TWO_SIDED|95.0|2.33|53.68|||Cochran-Mantel-Haenszel|Stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|Common OR stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|I-IGA Success at Week 8 Odds Ratio||53.68|2.33|0.0004
70947109|NCT04211389|141394674|SUPERIORITY||Odds Ratio (OR)|15.27||||0.0002|TWO_SIDED|95.0|3.1|75.35|||Cochran-Mantel-Haenszel|Stratified by pooled study site and baseline IGA with multiple imputation of missing data.|Common odds ratio stratified by pooled study site and baseline IGA with multiple imputation of missing data.|I-IGA Clear at Week 8 Odds Ratio||75.35|3.10|0.0002
70947110|NCT04211389|141394675|SUPERIORITY|WI-NRS Success at Week 2 Odds Ratio|Odds Ratio (OR)|2.56||||0.0026|TWO_SIDED|95.0|1.43|4.58|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common OR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|||4.58|1.43|0.0026
71130962|NCT02391363|141765795|SUPERIORITY|||||||0.59||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.30 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month GDS-SF, controlling for baseline GDS-SF.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.59
71130963|NCT02391363|141765796|SUPERIORITY|||||||0.64||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.22 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month ISI, controlling for baseline ISI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.64
71130964|NCT02391363|141765797|SUPERIORITY|||||||0.35||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.88 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month ISI, controlling for baseline ISI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.35
71130965|NCT02391363|141765798|SUPERIORITY|||||||0.52||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.42 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month LL-FDI, controlling for baseline LL-FDI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.52
71130966|NCT02391363|141765799|SUPERIORITY|||||||0.92||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = .01(Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month LL-FDI, controlling for baseline LL-FDI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.92
71130967|NCT02391363|141765800|SUPERIORITY|||||||0.59||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.29 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month LL-FDI, controlling for baseline LL-FDI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.59
71130968|NCT02391363|141765801|SUPERIORITY|||||||0.89||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.20 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month LL-FDI, controlling for baseline LL-FDI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.89
71130969|NCT02391363|141765802|SUPERIORITY|||||||0.64||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F= 0.23 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month SF-12, controlling for baseline SF-12.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.64
70947111|NCT04211389|141394675|SUPERIORITY|WI-NRS Success at Week 4 Odds Ratio|Odds Ratio (OR)|4.93|||<|0.0001|TWO_SIDED|95.0|2.65|9.18|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common OR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|||9.18|2.65|<0.0001
70860089|NCT02129777|141206680|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.503||0.211|TWO_SIDED|95.0|-1.63|0.36|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.36|-1.63|0.211
70860090|NCT02129777|141206680|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.497||0.087|TWO_SIDED|95.0|-1.85|0.13|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.13|-1.85|0.087
70860091|NCT02129777|141206680|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.494||0.58|TWO_SIDED|95.0|-1.26|0.71|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.71|-1.26|0.580
71130970|NCT02391363|141765803|SUPERIORITY|||||||0.94||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.00 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month SF-12, controlling for baseline SF-12.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.94
70860092|NCT02129777|141206680|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.496||0.873|TWO_SIDED|95.0|-1.06|0.9|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.90|-1.06|0.873
70860093|NCT02129777|141206681|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|6.7||0.803|TWO_SIDED|95.0|-15.2|11.8|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||11.8|-15.2|0.803
70860094|NCT02129777|141206681|SUPERIORITY_OR_OTHER||LS Mean Difference|7.9|STANDARD_ERROR_OF_MEAN|6.73||0.248|TWO_SIDED|95.0|-5.7|21.4|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||21.4|-5.7|0.248
70860095|NCT02129777|141206681|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|6.67||0.914|TWO_SIDED|95.0|-12.7|14.2|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||14.2|-12.7|0.914
70860096|NCT02129777|141206681|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3|STANDARD_ERROR_OF_MEAN|6.74||0.523|TWO_SIDED|95.0|-9.2|17.9|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||17.9|-9.2|0.523
70860097|NCT02129777|141206682|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.37||0.978|TWO_SIDED|95.0|-2.7|2.8|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an Analysis of covariance (ANCOVA) model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||2.8|-2.7|0.978
70860098|NCT02129777|141206682|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|1.36||0.389|TWO_SIDED|95.0|-3.9|1.5|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||1.5|-3.9|0.389
70860099|NCT02129777|141206682|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|1.39||0.316|TWO_SIDED|95.0|-4.2|1.4|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||1.4|-4.2|0.316
71130971|NCT02391363|141765804|SUPERIORITY|||||||0.98||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.00 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month SF-12, controlling for baseline SF-12.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.98
71130972|NCT02391363|141765805|SUPERIORITY|||||||0.88||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F= 0.02 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month SF-12, controlling for baseline SF-12.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.88
71130973|NCT02391363|141765806|SUPERIORITY|||||||0.31||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 1.02 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month PCL-5, controlling for baseline PCL-5.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.31
71130974|NCT02391363|141765807|SUPERIORITY|||||||0.96||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.00 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month PCL-5, controlling for baseline PCL-5.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.96
71130975|NCT02391363|141765808|SUPERIORITY|"We expected to reject the null hypothesis of no treatment group difference in 6 month health service use, controlling for baseline health service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||||0.52||||||Parameter estimate for treatment group = 0.40 (SE = 0.63). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||||||0.52
71130976|NCT02391363|141765809|SUPERIORITY|||||||0.04||||||Parameter estimate for treatment group = 1.79 (SE = 0.85). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 9 month health service use, controlling for baseline health service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.04
71130977|NCT02391363|141765810|SUPERIORITY|||||||0.04||||||Parameter estimate for treatment group = 1.56 (SE = 0.74). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 6 month hospital admissions, controlling for baseline hospital admissions.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.04
70860100|NCT02129777|141206682|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|1.41||0.142|TWO_SIDED|95.0|-4.9|0.7|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.7|-4.9|0.142
70860101|NCT02129777|141206683|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|1.73||0.229|TWO_SIDED|95.0|-5.6|1.4|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Physical Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||1.4|-5.6|0.229
70860102|NCT02129777|141206683|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.65||0.863|TWO_SIDED|95.0|-3.6|3.0|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Physical Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||3.0|-3.6|0.863
70860103|NCT02129777|141206683|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|1.67||0.403|TWO_SIDED|95.0|-1.9|4.7|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Physical Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||4.7|-1.9|0.403
70860104|NCT02129777|141206683|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.74||0.597|TWO_SIDED|95.0|-2.5|4.4|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Physical Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||4.4|-2.5|0.597
70860105|NCT02129777|141206683|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|2.32||0.416|TWO_SIDED|95.0|-2.7|6.5|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Mental Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||6.5|-2.7|0.416
70860106|NCT02129777|141206683|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|2.24||0.77|TWO_SIDED|95.0|-3.8|5.1|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Mental Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||5.1|-3.8|0.770
70860107|NCT02129777|141206683|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|2.31||0.798|TWO_SIDED|95.0|-4.0|5.2|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Mental Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||5.2|-4.0|0.798
70860108|NCT02129777|141206683|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|2.4||0.767|TWO_SIDED|95.0|-4.1|5.5|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Mental Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||5.5|-4.1|0.767
70860109|NCT02129777|141206684|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.043||0.57|TWO_SIDED|95.0|-0.11|0.06|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.06|-0.11|0.570
70860110|NCT02129777|141206684|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.042||0.619|TWO_SIDED|95.0|-0.1|0.06|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.06|-0.10|0.619
70860111|NCT02129777|141206684|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.043||0.597|TWO_SIDED|95.0|-0.06|0.11|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.11|-0.06|0.597
70860112|NCT02129777|141206684|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.044||0.509|TWO_SIDED|95.0|-0.06|0.12|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.12|-0.06|0.509
70947112|NCT04211389|141394675|SUPERIORITY|WI-NRS Success at Week 8 Odds Ratio|Odds Ratio (OR)|3.59|||<|0.0001|TWO_SIDED|95.0|2.07|6.23|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common OR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|||6.23|2.07|<0.0001
70947113|NCT04211389|141394676|SUPERIORITY||Mean Difference (Final Values)|-26.0|||<|0.0001|TWO_SIDED|95.0|-31.9|-20.0|||ANCOVA|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|LS Mean Difference at Week 4||-20.0|-31.9|<0.0001
70860113|NCT02129777|141206685|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|5.32||0.845|TWO_SIDED|95.0|-11.7|9.6|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||9.6|-11.7|0.845
70860114|NCT02129777|141206685|SUPERIORITY_OR_OTHER||LS Mean Difference|4.8|STANDARD_ERROR_OF_MEAN|4.8||0.323|TWO_SIDED|95.0|-4.8|14.4|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||14.4|-4.8|0.323
70860115|NCT02129777|141206685|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|4.89||0.697|TWO_SIDED|95.0|-11.7|7.8|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||7.8|-11.7|0.697
70860116|NCT02129777|141206685|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|5.1||0.633|TWO_SIDED|95.0|-12.6|7.7|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||7.7|-12.6|0.633
70947114|NCT04211389|141394676|SUPERIORITY||Mean Difference (Final Values)|-26.5|||<|0.0001|TWO_SIDED|95.0|-33.2|-19.7|||ANCOVA|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|LS Mean Difference at Week 8||-19.7|-33.2|<0.0001
70947115|NCT02357264|141394677|OTHER|||||||0.162|||||||Fisher Exact|||||||.162
70947116|NCT00087555|141394684|SUPERIORITY_OR_OTHER|||||||0.052||95.0|||||Chi-squared|||||||0.052
70947117|NCT00087555|141394684|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||Chi-squared|||||||0.024
70947118|NCT00087555|141394684|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Chi-squared|||||||0.035
70947119|NCT01062971|141394687|NON_INFERIORITY|Noninferiority was determined if the treatments did not show differences greater than 20%||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
70947120|NCT01062971|141394688|NON_INFERIORITY|Noninferiority was determined if the treatments did not show differences greater than 20%.|||||>|0.05|||||||t-test, 2 sided|||||||>0.05
70860117|NCT02129777|141206686|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.64||0.537|TWO_SIDED|95.0|-2.2|4.3|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site,treatment,visit and interaction between visit and treatment as fixed effects,baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||4.3|-2.2|0.537
71130978|NCT02391363|141765811|SUPERIORITY|||||||0.001||||||Parameter estimate for treatment group = 2.96 (SE = 0.91). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 9 month hospital admissions, controlling for baseline hospital admissions.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.001
71130979|NCT02391363|141765812|SUPERIORITY|||||||0.42||||||Parameter estimate for treatment group = 0.42 (SE = 0.51). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 6 month social service use, controlling for baseline social service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.42
70860118|NCT02129777|141206686|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|1.62||0.142|TWO_SIDED|95.0|-0.8|5.6|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site,treatment,visit and interaction between visit and treatment as fixed effects,baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||5.6|-0.8|0.142
71130980|NCT02391363|141765813|SUPERIORITY|||||||0.85||||||Parameter estimate for treatment group = 0.09 (SE = 0.47). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 9 month social service use, controlling for baseline social service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.85
71130981|NCT02391363|141765814|SUPERIORITY|||||||0.55||||||Parameter estimate for treatment group = -0.28 (SE = 0.46). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 6 month psychological service use, controlling for baseline psychological service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.55
71130982|NCT02391363|141765815|SUPERIORITY|||||||0.54||||||Parameter estimate for treatment group = -0.29 (SE = 0.47). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 9 month psychological service use, controlling for baseline psychological service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.54
71130983|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio (GMR)|1.14|||||TWO_SIDED|95.0|0.95|1.37||||||Serotype 1: Geometric mean ratios (GMRs) (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% confidence intervals (CIs).||1.37|0.95|
71130984|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio (GMR)|1.01|||||TWO_SIDED|95.0|0.88|1.16||||||Serotype 3: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.16|0.88|
71130985|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.96|||||TWO_SIDED|95.0|0.78|1.17||||||Serotype 4: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.17|0.78|
71130986|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.77|1.12||||||Serotype 5: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.12|0.77|
71130987|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.24|||||TWO_SIDED|95.0|1.03|1.5||||||Serotype 6A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.50|1.03|
71130988|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.01|||||TWO_SIDED|95.0|0.85|1.21||||||Serotype 6B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.21|0.85|
71130989|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.98|||||TWO_SIDED|95.0|0.82|1.17||||||Serotype 7F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.17|0.82|
71130990|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.11|||||TWO_SIDED|95.0|0.93|1.33||||||Serotype 9V: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.33|0.93|
71130991|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.07|||||TWO_SIDED|95.0|0.9|1.27||||||Serotype 14: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.27|0.90|
71130992|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.88|||||TWO_SIDED|95.0|0.72|1.07||||||Serotype 18C: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.07|0.72|
71130993|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.95|||||TWO_SIDED|95.0|0.81|1.12||||||Serotype 19A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.12|0.81|
71130994|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.81|1.21||||||Serotype 19F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.21|0.81|
71130995|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.92|||||TWO_SIDED|95.0|0.72|1.16||||||Serotype 23F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.16|0.72|
70860119|NCT02129777|141206686|SUPERIORITY_OR_OTHER||LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|1.63||0.015|TWO_SIDED|95.0|0.8|7.3|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site,treatment,visit and interaction between visit and treatment as fixed effects,baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||7.3|0.8|0.015
70860120|NCT02129777|141206686|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.64||0.121|TWO_SIDED|95.0|-0.7|5.8|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site,treatment,visit and interaction between visit and treatment as fixed effects,baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||5.8|-0.7|0.121
70860121|NCT01856023|141206706|SUPERIORITY|one -sample binomial test - 1-year estimated OS for these 28 patients was 75% (95%CI: 51%, 88%)||||||0.001||||||compared to the historical control rate of 46% one year survival|Log Rank|||OS rates of the Evaluable population in entire cohort was compared with the historical control rate of 46% (Hodi, et al NEJM 2010) using a one-sample binomial test due to early termination of enrollment without reaching target accrual; planned analysis to be the difference between treatment arms using log-rank test. One year OS along with 95% CI estimated for entire population and each treatment arm separately.||||.001
70860122|NCT00322153|141206710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.001|TWO_SIDED|95.0|1.0|4.2|||ANCOVA|Least-squares mean (-0.4 in placebo and 2.2 in memantine ER) are controlled for center and adjusted for SIB baseline value.||The co-primary efficacy parameter was change from Baseline to Week 24 in SIB total score. Missing SIB total scores at Week 24 were imputed using the last-observation-carried-forward (LOCF) approach.||4.2|1.0|0.001
70860123|NCT00322153|141206711|SUPERIORITY_OR_OTHER|||||||0.008|||||||Cochran-Mantel-Haenszel|||The co-primary efficacy parameter was CIBIC-Plus total score at week 24. Missing CIBIC-Plus total scores at Week 24 were imputed using the last-observation-carried-forward (LOCF) approach.||||0.008
70860124|NCT00322153|141206712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.177|TWO_SIDED|95.0|-0.3|1.8|||ANCOVA|Least-squares mean (-1.7 in placebo and -1.0 in memantine ER) are controlled for center and adjusted for ADCS-ADL19 baseline value.||The secondary efficacy parameter was change from Baseline at Week 24 in the total score of the 19-Item Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL19). Missing scores at week 24 were imputed using the last-observation-carried-forward (LOCF) approach.||1.8|-0.3|0.177
70860125|NCT02797054|141206748|OTHER|||||||0.069|||||||Chi-squared|||||||0.069
70860126|NCT02797054|141206749|OTHER|||||||0.303|||||||Chi-squared|||||||0.303
70860127|NCT02797054|141206750|OTHER|||||||0.001|||||||Chi-squared|||||||0.001
71130996|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.19|||||TWO_SIDED|95.0|1.0|1.4||||||Serotype 8: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.40|1.00|
70860128|NCT02797054|141206751|OTHER|||||||0.895|||||||Chi-squared|||||||0.895
70860129|NCT02797054|141206752|OTHER|||||||0.58|||||||Chi-squared|||||||0.58
70860130|NCT02797054|141206753|OTHER|||||||0.0015|||||||Chi-squared|||||||0.0015
70860131|NCT02797054|141206754|OTHER|||||||0.0056|||||||Chi-squared|||||||0.0056
70860132|NCT02797054|141206755|OTHER|||||||0.21|||||||Chi-squared|||||||0.21
70860133|NCT04644783|141206756|SUPERIORITY||||||<|0.0001|||||||Regression, non-linear mixed effects|||||||<0.0001
70860134|NCT04644783|141206757|SUPERIORITY||||||<|0.0001|||||||Regression, non-linear mixed effects|||||||<0.0001
70860135|NCT04571515|141206783|SUPERIORITY||Mean Difference (Final Values)|28.3|STANDARD_ERROR_OF_MEAN|9.25||0.003|TWO_SIDED|95.0|9.9|46.6|||Emax|||||46.6|9.9|0.003
70860136|NCT04571515|141206783|SUPERIORITY||Mean Difference (Final Values)|29.6|STANDARD_ERROR_OF_MEAN|7.94|<|0.001|TWO_SIDED|95.0|13.8|45.3|||Emax|||||45.3|13.8|<0.001
70860137|NCT04571515|141206783|SUPERIORITY||Mean Difference (Final Values)|30.3|STANDARD_ERROR_OF_MEAN|8.04|<|0.001|TWO_SIDED|95.0|14.4|46.2|||Emax|||||46.2|14.4|<0.001
70860138|NCT04571515|141206783|SUPERIORITY||Mean Difference (Final Values)|31.1|STANDARD_ERROR_OF_MEAN|8.87|<|0.001|TWO_SIDED|95.0|13.5|48.6|||Emax|||||48.6|13.5|<0.001
70860139|NCT04571515|141206784|OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-1.4|1.1||||||||1.1|-1.4|
70860140|NCT04571515|141206784|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-1.5|0.9||||||||0.9|-1.5|
70860141|NCT04571515|141206784|OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-1.8|0.6||||||||0.6|-1.8|
70860142|NCT04571515|141206784|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-1.1|1.3||||||||1.3|-1.1|
70860143|NCT04571515|141206785|SUPERIORITY||Mean Difference (Final Values)|15.2|STANDARD_ERROR_OF_MEAN|3.99|<|0.001|TWO_SIDED|95.0|7.3|23.1|||Emax|||||23.1|7.3|<0.001
70860144|NCT04571515|141206785|SUPERIORITY||Mean Difference (Final Values)|16.1|STANDARD_ERROR_OF_MEAN|3.43|<|0.001|TWO_SIDED|95.0|9.3|22.9|||Emax|||||22.9|9.3|<0.001
70860145|NCT04571515|141206785|SUPERIORITY||Mean Difference (Final Values)|16.5|STANDARD_ERROR_OF_MEAN|3.47|<|0.001|TWO_SIDED|95.0|9.7|23.4|||Emax|||||23.4|9.7|<0.001
70860146|NCT04571515|141206785|SUPERIORITY||Mean Difference (Final Values)|17.1|STANDARD_ERROR_OF_MEAN|3.84|<|0.001|TWO_SIDED|95.0|9.4|24.7|||Emax|||||24.7|9.4|<0.001
70860147|NCT04571515|141206786|SUPERIORITY|||||||0.208|||||||Log Rank|||Time to Perceptible Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.208
71130997|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.11|||||TWO_SIDED|95.0|0.91|1.36||||||Serotype 10A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.36|0.91|
71130998|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.29|||||TWO_SIDED|95.0|1.03|1.6||||||Serotype 11A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.60|1.03|
70860148|NCT04571515|141206786|SUPERIORITY|||||||0.005|||||||Log Rank|||Time to Perceptible Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.005
70860149|NCT04571515|141206786|SUPERIORITY|||||||0.192|||||||Log Rank|||Time to Perceptible Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.192
70860150|NCT04571515|141206786|SUPERIORITY|||||||0.067|||||||Log Rank|||Time to Perceptible Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.067
70860151|NCT04571515|141206786|SUPERIORITY|||||||0.059|||||||Log Rank|||Time to Meaningful Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.059
70860152|NCT04571515|141206786|SUPERIORITY||||||<|0.001|||||||Log Rank|||Time to Meaningful Pain Relief Subjects are censored at 24 hours if they do not report relief.||||<0.001
70860153|NCT04571515|141206786|SUPERIORITY|||||||0.017|||||||Log Rank|||Time to Meaningful Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.017
70860154|NCT04571515|141206786|SUPERIORITY|||||||0.002|||||||Log Rank|||Time to Meaningful Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.002
70860155|NCT04571515|141206787|SUPERIORITY|||||||0.051|||||||Regression, Logistic|||||||0.051
70860156|NCT04571515|141206787|SUPERIORITY|||||||0.035|||||||Regression, Logistic|||||||0.035
70860157|NCT04571515|141206787|SUPERIORITY|||||||0.016|||||||Regression, Logistic|||||||0.016
70860158|NCT04571515|141206787|SUPERIORITY|||||||0.18|||||||Regression, Logistic|||||||0.180
70860159|NCT04571515|141206788|SUPERIORITY|||||||0.022|||||||Wilcoxon Rank Sum|||||||0.022
70860160|NCT04571515|141206788|SUPERIORITY|||||||0.028|||||||Wilcoxon Rank Sum|||||||0.028
70860161|NCT04571515|141206788|SUPERIORITY|||||||0.007|||||||Wilcoxon Rank Sum|||||||0.007
70860162|NCT04571515|141206788|SUPERIORITY|||||||0.005|||||||Wilcoxon Rank Sum|||||||0.005
70860163|NCT01711372|141206826|OTHER||||||||||||||Chi-squared|||AUC or ROC for Groundskeeper Game|AUC of ROC is 0.78|||
70860164|NCT01711372|141206827|OTHER||||||||||||||||||AUC of ROC. Proportion of accurate ADHD diagnoses is 0.76|||
70860165|NCT01711372|141206828|OTHER|AUC of ROC|||||||||||||||||AUC of ROC. Proportion of accurate ADHD diagnosis is 0.62|||
70860166|NCT00905827|141206838|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||Pairwise comparisons (ANOVA simple effect comparisons) adjusted for baseline scores||||<0.01
70860167|NCT00905827|141206838|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANOVA|||Pairwise comparisons (ANOVA simple effect comparisons) adjusted for baseline scores||||0.01
70860168|NCT00509392|141206840|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
70860169|NCT00509392|141206841|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
70860170|NCT00509392|141206842|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
70860171|NCT00509392|141206843|SUPERIORITY_OR_OTHER|||||||0.2962||95.0|||||t-test, 2 sided|||||||0.2962
70860172|NCT00509392|141206844|SUPERIORITY_OR_OTHER|||||||0.0048||95.0|||||t-test, 2 sided|||||||0.0048
70860173|NCT00509392|141206845|SUPERIORITY_OR_OTHER|||||||0.0036||95.0|||||t-test, 2 sided|||||||0.0036
70860174|NCT00509392|141206846|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||t-test, 2 sided|||||||0.0005
70860175|NCT00509392|141206847|SUPERIORITY_OR_OTHER|||||||0.5761||95.0|||||t-test, 2 sided|||||||0.5761
70860176|NCT00509392|141206848|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
70860177|NCT00509392|141206849|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
70860178|NCT00509392|141206850|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
70860179|NCT00509392|141206851|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Fisher Exact|||||||0.0050
70860180|NCT00509392|141206853|SUPERIORITY_OR_OTHER|||||||0.0009||95.0|||||t-test, 2 sided|||||||0.0009
70860181|NCT00509392|141206854|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||t-test, 2 sided|||||||0.0002
70860182|NCT00509392|141206855|SUPERIORITY_OR_OTHER|||||||0.0035||95.0|||||t-test, 2 sided|||||||0.0035
70860183|NCT00509392|141206856|SUPERIORITY_OR_OTHER|||||||0.2825||95.0|||||t-test, 2 sided|||||||0.2825
70860184|NCT00509392|141206857|SUPERIORITY_OR_OTHER|||||||0.0854||95.0|||||t-test, 2 sided|||||||0.0854
70860185|NCT00509392|141206858|SUPERIORITY_OR_OTHER|||||||0.0044||95.0|||||t-test, 2 sided|||||||0.0044
70860186|NCT00509392|141206859|SUPERIORITY_OR_OTHER|||||||0.0457||95.0|||||t-test, 2 sided|||||||0.0457
70860187|NCT00509392|141206860|SUPERIORITY_OR_OTHER|||||||0.9463||95.0|||||t-test, 2 sided|||||||0.9463
70860188|NCT04902326|141206863|SUPERIORITY|||||||0.78|||||||Regression, Linear|||Compare the mean decrease of HbA1c of the Combo Arm, Financial Incentives arm, and the Tailored Messages arm each with the EUC arm.||||0.78
70860189|NCT04902326|141206864|SUPERIORITY|||||||0.64|||||||Regression, Linear|||Compare the mean decrease of HbA1c of the Combo Arm, Financial Incentives arm, and the Tailored Messages arm each with the EUC arm.||||0.64
70860190|NCT04902326|141206865|SUPERIORITY|||||||0.87|||||||Regression, Linear|||Compare the mean decrease of weight of the Combo Arm, Financial Incentives arm, and the Tailored Messages arm each with the EUC arm.||||0.87
70860191|NCT04902326|141206866|SUPERIORITY|||||||0.87|||||||Regression, Linear|||Compare the mean decrease of weight of the Combo Arm, Financial Incentives arm, and the Tailored Messages arm each with the EUC arm.||||0.87
70860192|NCT04902326|141206867|SUPERIORITY||||||<|0.0001|||||||Regression, Linear|||Compare the mean months engaged (with DPP or metformin) of the Combo Arm, Financial Incentives arm, and the Tailored Messages arm each with the EUC arm.||||<0.0001
71130999|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.08|||||TWO_SIDED|95.0|0.88|1.33||||||Serotype 12F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.33|0.88|
70947121|NCT01182207|141394709|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.74|||||TWO_SIDED|90.0|86.82|107.79|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||107.79|86.82|
71131000|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.16|||||TWO_SIDED|95.0|0.91|1.46||||||Serotype 15B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.46|0.91|
71131001|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.12|||||TWO_SIDED|95.0|0.87|1.43||||||Serotype 22F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.43|0.87|
71131002|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.04|||||TWO_SIDED|95.0|0.83|1.3||||||Serotype 33F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.30|0.83|
70860193|NCT01617148|141206883|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71131003|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.21|||||TWO_SIDED|95.0|1.01|1.46||||||Serotype 1: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.46|1.01|
71131004|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.96|1.26||||||Serotype 3: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.26|0.96|
70860194|NCT01617148|141206884|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70860195|NCT01617148|141206885|SUPERIORITY_OR_OTHER|||||||0.038|||||||t-test, 2 sided|||||||0.038
70860196|NCT01617148|141206886|SUPERIORITY_OR_OTHER|||||||0.038|||||||t-test, 2 sided|||||||0.038
70860197|NCT00423670|141206892|SUPERIORITY_OR_OTHER||Percent difference in SVR|16.7||||0.0126|TWO_SIDED|95.0|3.5|30.0|||Cochran-Mantel Haenszel Chi-square test|Adjusted for baseline stratification factors: black versus non-black, and cirrhosis versus no cirrhosis.||||30|3.5|0.0126
70860198|NCT00423670|141206892|SUPERIORITY_OR_OTHER||Percent difference in SVR|18.8||||0.0048|TWO_SIDED|95.0|5.5|32.2|||Cochran-Mantel Haenszel Chi-square test|Adjusted for baseline stratification factors: black versus non-black, and cirrhosis versus no cirrhosis.||||32.2|5.5|0.0048
70860199|NCT00423670|141206892|SUPERIORITY_OR_OTHER||Percent difference in SVR|29.5|||<|0.0001|TWO_SIDED|95.0|16.5|42.5|||Cochran-Mantel Haenszel Chi-square test|Adjusted for baseline stratification factors: black versus non-black, and cirrhosis versus no cirrhosis.||||42.5|16.5|<0.0001
70860200|NCT00423670|141206892|SUPERIORITY_OR_OTHER||Percent difference in SVR|37.3|||<|0.0001|TWO_SIDED|95.0|24.7|49.8|||Cochran-Mantel Haenszel Chi-square test|Adjusted for baseline stratification factors: black versus non-black, and cirrhosis versus no cirrhosis.||||49.8|24.7|<0.0001
70860201|NCT00423670|141206893|SUPERIORITY_OR_OTHER||Percent difference in SVR rates|5.1||||0.2864|TWO_SIDED|95.0|-4.2|14.3|||Cochran-Mantel-Haenszel Chi-Square Test|Adjusted for baseline stratification factors: black versus non black, and cirrhosis versus no cirrhosis.||||14.3|-4.2|0.2864
70860202|NCT00423670|141206894|SUPERIORITY_OR_OTHER||Percent difference in SVR rates|15.6||||0.0009|TWO_SIDED|95.0|6.5|24.8|||Cochran-Mantel-Haenszel Chi-Square Test|Adjusted for the baseline stratification factors: black versus non black, and cirrhosis versus no cirrhosis.||||24.8|6.5|0.0009
70860203|NCT01858636|141206939|SUPERIORITY_OR_OTHER|||||||0.0029|TWO_SIDED||||||Fisher Exact|A one-sided Fisher's exact test was performed with a 95% upper confidence bound of 5.5%||Ho: Pt ≥ 8% Ha: Pt \< 8%, where Pt is the proportion of deployed subjects with a protocol-defined vascular complication.||||0.0029
70860204|NCT01858636|141206940|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|A one-sided Fisher's exact test was performed with a 95% lower confidence bound of 96.4%||Ho: St ≤ 90% Ha: St \> 90%, where St is the proportion of deployed subjects achieving hemostasis within 5 minutes.||||<0.0001
70860205|NCT01227564|141206977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002||||0.9538|TWO_SIDED|95.0|-0.075|0.071||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 52.||0.071|-0.075|0.9538
70860206|NCT01227564|141206977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.006||||0.8787|TWO_SIDED|95.0|-0.07|0.081||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 10 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 52.||0.081|-0.070|0.8787
70860207|NCT01227564|141206977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.002||||0.9544|TWO_SIDED|95.0|-0.062|0.066||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg or ACC 10 µg + QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 52.||0.066|-0.062|0.9544
70947122|NCT01182207|141394710|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.16|||||TWO_SIDED|90.0|101.1|105.27|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||105.27|101.10|
70860208|NCT01227564|141206977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003||||0.955|TWO_SIDED|95.0|-0.106|0.112||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 78.||0.112|-0.106|0.9550
70872052|NCT02155608|141229483|SUPERIORITY||||||<|0.0001||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time2: F = 28.96, df = 1/228.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||<.0001
70872053|NCT02155608|141229483|SUPERIORITY|||||||0.02||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 6.23, df = 1/57.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.02
70947123|NCT01182207|141394711|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.72|||||TWO_SIDED|90.0|100.67|104.8|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104.80|100.67|
70947124|NCT01182207|141394712|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.6|||||TWO_SIDED|90.0|89.45|106.5|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||106.50|89.45|
71131005|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.82|1.22||||||Serotype 4: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.22|0.82|
71131006|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.08|||||TWO_SIDED|95.0|0.89|1.31||||||Serotype 5: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.31|0.89|
71131007|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.4|||||TWO_SIDED|95.0|1.16|1.69||||||Serotype 6A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.69|1.16|
71131008|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.13|||||TWO_SIDED|95.0|0.94|1.35||||||Serotype 6B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.35|0.94|
71131009|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.97|||||TWO_SIDED|95.0|0.81|1.16||||||Serotype 7F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.16|0.81|
71131010|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.04|||||TWO_SIDED|95.0|0.87|1.25||||||Serotype 9V: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.25|0.87|
71131011|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.12|||||TWO_SIDED|95.0|0.94|1.33||||||Serotype 14: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.33|0.94|
71131012|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.92|||||TWO_SIDED|95.0|0.75|1.13||||||Serotype 18C: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.13|0.75|
71131013|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.02|||||TWO_SIDED|95.0|0.86|1.2||||||Serotype 19A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.20|0.86|
71131014|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.96|||||TWO_SIDED|95.0|0.78|1.17||||||Serotype 19F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.17|0.78|
71131015|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.78|1.25||||||Serotype 23F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.25|0.78|
71131016|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.98|||||TWO_SIDED|95.0|0.83|1.16||||||Serotype 8: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.16|0.83|
71131017|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.06|||||TWO_SIDED|95.0|0.87|1.3||||||Serotype 10A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.30|0.87|
71131018|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.8|1.24||||||Serotype 11A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.24|0.80|
71131019|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.16|||||TWO_SIDED|95.0|0.94|1.42||||||Serotype 12F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.42|0.94|
71131020|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.05|||||TWO_SIDED|95.0|0.82|1.33||||||Serotype 15B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.33|0.82|
71131021|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.98|||||TWO_SIDED|95.0|0.77|1.26||||||Serotype 22F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.26|0.77|
71131022|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.03|||||TWO_SIDED|95.0|0.82|1.29||||||Serotype 33F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.29|0.82|
70860209|NCT01227564|141206977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008||||0.8874|TWO_SIDED|95.0|-0.121|0.105||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 10 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 78.||0.105|-0.121|0.8874
70947125|NCT01182207|141394713|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.88|||||TWO_SIDED|90.0|95.62|102.25|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||102.25|95.62|
70947126|NCT01182207|141394714|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.2|||||TWO_SIDED|90.0|95.36|101.12|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.12|95.36|
70947127|NCT01161628|141394716|SUPERIORITY_OR_OTHER||||||<|0.5|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis: p (CR rate) is 0.5 or less versus... Alternative hypothesis: p \>0.5 A sample size of 25 patients gives 90% power with an alpha = 0.05||||<0.5
70947128|NCT00715117|141394725|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||||||0.005
70947129|NCT00715117|141394725|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
70947130|NCT00715117|141394726|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Bowel symptoms||||>0.05
70947131|NCT00715117|141394726|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||t-test, 2 sided|||Social well-being||||0.035
71131023|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.06|||||TWO_SIDED|95.0|0.89|1.28||||||Serotype 1: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.28|0.89|
70860210|NCT01227564|141206977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002||||0.9595|TWO_SIDED|95.0|-0.099|0.095||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg or ACC 10 µg + QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 78.||0.095|-0.099|0.9595
70947132|NCT00715117|141394726|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Emotional well-being||||>0.05
70947133|NCT00715117|141394726|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED|95.0||||Systemic symptoms|t-test, 2 sided|||||||0.035
70947134|NCT00715117|141394726|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Body Image||||>0.05
70947135|NCT00715117|141394727|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Sleep disturbance||||1.0
70947136|NCT00715117|141394727|SUPERIORITY_OR_OTHER|||||||0.45|||||||Fisher Exact|||Unusual dreams||||0.45
70947137|NCT00715117|141394727|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Twitching||||1.0
70947138|NCT00715117|141394727|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Headaches||||1.0
70947139|NCT00715117|141394727|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Decreased appetite||||1.0
70947140|NCT00715117|141394727|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Nausea||||1.0
70947141|NCT00715117|141394727|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Hair loss||||1.0
70947142|NCT00715117|141394727|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Fatigue||||1.0
70947143|NCT00715117|141394727|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Flushed ears||||1.0
70947144|NCT00715117|141394727|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Papules, rash||||1.0
70947145|NCT00715117|141394727|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Double vision||||1.0
70947146|NCT01482429|141394728|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||binomial test|||||||0.03
70947147|NCT01482429|141394729|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
70947148|NCT02037256|141394764|OTHER||percentage|0.24|||||TWO_SIDED|95.0|0.07|0.5||||||Median time to engraftment||0.50|0.07|
71131024|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.09|||||TWO_SIDED|95.0|0.95|1.24||||||Serotype 3: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.24|0.95|
71131025|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.04|||||TWO_SIDED|95.0|0.85|1.27||||||Serotype 4: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.27|0.85|
71131026|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.16|||||TWO_SIDED|95.0|0.96|1.41||||||Serotype 5: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.41|0.96|
70860211|NCT01227564|141206977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.3826|TWO_SIDED|95.0|-0.164|0.064||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 104.||0.064|-0.164|0.3826
70860212|NCT01227564|141206977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.049||||0.3912|TWO_SIDED|95.0|-0.164|0.065||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 10 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 104.||0.065|-0.164|0.3912
70860213|NCT01227564|141206977|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.05||||0.3221|TWO_SIDED|95.0|-0.149|0.05||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg or ACC 10 µg + QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 104.||0.050|-0.149|0.3221
70860214|NCT01227564|141206978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|48.18||||0.9384|TWO_SIDED|95.0|-1197.07|1293.42||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||Analysis of Covariance (ANCOVA) was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||1293.42|-1197.07|0.9384
70860215|NCT01227564|141206978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|581.98||||0.3945|TWO_SIDED|95.0|-778.17|1942.13||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||1942.13|-778.17|0.3945
70860216|NCT01227564|141206978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|315.08||||0.5773|TWO_SIDED|95.0|-812.15|1442.3||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||1442.30|-812.15|0.5773
70860217|NCT01227564|141206979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.16||||0.5818|TWO_SIDED|95.0|-63.31|111.62||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||111.62|-63.31|0.5818
70860218|NCT01227564|141206979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|84.42||||0.0648|TWO_SIDED|95.0|-5.37|174.21||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||174.21|-5.37|0.0648
70860219|NCT01227564|141206979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|54.29||||0.1672|TWO_SIDED|95.0|-23.47|132.05||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||132.05|-23.47|0.1672
70860220|NCT01227564|141206980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.36||||0.3106|TWO_SIDED|95.0|-9.94|3.22||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||3.22|-9.94|0.3106
70860221|NCT01227564|141206980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.51||||0.1876|TWO_SIDED|95.0|-11.28|2.27||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||2.27|-11.28|0.1876
71131027|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.13|||||TWO_SIDED|95.0|0.93|1.36||||||Serotype 6A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.36|0.93|
70860222|NCT01227564|141206980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.93||||0.1742|TWO_SIDED|95.0|-9.66|1.79||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||1.79|-9.66|0.1742
70860223|NCT01227564|141206981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.36||||0.4089|TWO_SIDED|95.0|-103.52|42.81||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||42.81|-103.52|0.4089
71131028|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.11|||||TWO_SIDED|95.0|0.93|1.33||||||Serotype 6B: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.33|0.93|
71131029|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.83|1.19||||||Serotype 7F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.19|0.83|
71131030|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.94|||||TWO_SIDED|95.0|0.78|1.12||||||Serotype 9V: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.12|0.78|
71131031|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.04|||||TWO_SIDED|95.0|0.88|1.24||||||Serotype 14: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.24|0.88|
71131032|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.05|||||TWO_SIDED|95.0|0.86|1.29||||||Serotype 18C: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.29|0.86|
71131033|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.07|||||TWO_SIDED|95.0|0.91|1.25||||||Serotype 19A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.25|0.91|
71131034|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.96|||||TWO_SIDED|95.0|0.79|1.17||||||Serotype 19F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.17|0.79|
71131035|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.08|||||TWO_SIDED|95.0|0.85|1.37||||||Serotype 23F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.37|0.85|
71131036|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.83|||||TWO_SIDED|95.0|0.7|0.98||||||Serotype 8: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||0.98|0.70|
71131037|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.95|||||TWO_SIDED|95.0|0.78|1.17||||||Serotype 10A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.17|0.78|
71131038|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.77|||||TWO_SIDED|95.0|0.62|0.96||||||Serotype 11A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||0.96|0.62|
71131039|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.07|||||TWO_SIDED|95.0|0.87|1.31||||||Serotype 12F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.31|0.87|
71131040|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.91|||||TWO_SIDED|95.0|0.71|1.15||||||Serotype 15B: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.15|0.71|
71131041|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.88|||||TWO_SIDED|95.0|0.69|1.12||||||Serotype 22F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.12|0.69|
71131042|NCT03828617|141765821|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.79|1.24||||||Serotype 33F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.24|0.79|
71131043|NCT03688074|141765849|OTHER||Ratio of Geometric LSMeans|0.15|||<|0.001|TWO_SIDED|90.0|0.06|0.35||Nominal p-values were reported. No adjustment of multiplicity was performed.|ANCOVA|Model includes treatment+log transformed baseline value+stratification factor (screening eos count \[\<150, 150-\<300, \>=300 cells/uL\])|Parameter : Eosinophils (cells/mm\^2)||95% CI (0.05, 0.41)|0.35|0.06|<0.001
70860224|NCT01227564|141206981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-83.4||||0.0327|TWO_SIDED|95.0|-159.69|-7.11||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||-7.11|-159.69|0.0327
70860225|NCT01227564|141206981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-56.88||||0.0801|TWO_SIDED|95.0|-120.82|7.06||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||7.06|-120.82|0.0801
71131044|NCT03688074|141765849|OTHER||Ratio of Geometric LSMeans|1.36||||0.106|TWO_SIDED|90.0|0.99|1.86||Nominal p-values were reported. No adjustment of multiplicity was performed.|ANCOVA|Model includes treatment+log transformed baseline value+stratification factor (screening eos count \[\<150, 150-\<300, \>=300 cells/uL\])|Parameter: Neutrophils (cells/mm\^2)||95% CI (0.94, 1.97)|1.86|0.99|0.106
70860226|NCT01227564|141206982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.78||||0.4892|TWO_SIDED|95.0|-37.15|76.71||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 12.||76.71|-37.15|0.4892
70860227|NCT01227564|141206982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.06||||0.0915|TWO_SIDED|95.0|-8.51|110.63||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 12.||110.63|-8.51|0.0915
70860228|NCT01227564|141206982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.42||||0.1638|TWO_SIDED|95.0|-14.88|85.72||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 12.||85.72|-14.88|0.1638
70860229|NCT01227564|141206982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|99.29||||0.2006|TWO_SIDED|95.0|-54.28|252.86||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||252.86|-54.28|0.2006
70860230|NCT01227564|141206982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|225.63||||0.0067|TWO_SIDED|95.0|65.18|386.09||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||386.09|65.18|0.0067
70860231|NCT01227564|141206982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|162.46||||0.0204|TWO_SIDED|95.0|26.05|298.87||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||298.87|26.05|0.0204
70860232|NCT01227564|141206982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|114.13||||0.0766|TWO_SIDED|95.0|-12.63|240.89||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||240.89|-12.63|0.0766
71131045|NCT03688074|141765849|OTHER||Ratio of Geometric LSMeans|1.12||||0.389|TWO_SIDED|90.0|0.9|1.4||Nominal p-values were reported. No adjustment of multiplicity was performed.|ANCOVA|Model includes treatment+log transformed baseline value+stratification factor (screening eos count \[\<150, 150-\<300, \>=300 cells/uL\])|Parameter: T cells CD3+ (cells/mm\^2)||95% CI (0.86, 1.46)|1.40|0.90|0.389
71131046|NCT03688074|141765849|OTHER||Ratio of Geometric LSMeans|1.18||||0.216|TWO_SIDED|90.0|0.94|1.48||Nominal p-values were reported. No adjustment of multiplicity was performed.|ANCOVA|Model includes treatment+log transformed baseline value+stratification factor (screening eos count \[\<150, 150-\<300, \>=300 cells/uL\])|Parameter: T cells CD4+ (cells/mm\^2)||95% CI (0.90, 1.55)|1.48|0.94|0.216
70860233|NCT01227564|141206982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|226.82||||0.0181|TWO_SIDED|95.0|40.23|413.41||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||413.41|40.23|0.0181
70860234|NCT01227564|141206982|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|167.33||||0.0387|TWO_SIDED|95.0|9.03|325.63||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||325.63|9.03|0.0387
70860235|NCT01227564|141206982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|107.84||||0.2277|TWO_SIDED|95.0|-69.29|284.97||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||284.97|-69.29|0.2277
70860236|NCT01227564|141206982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|226.82||||0.0181|TWO_SIDED|95.0|40.23|413.41||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||413.41|40.23|0.0181
70860237|NCT01227564|141206982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|167.33||||0.0387|TWO_SIDED|95.0|9.03|325.63||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||325.63|9.03|0.0387
70860238|NCT01227564|141206982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|141.92||||0.0747|TWO_SIDED|95.0|-14.62|298.45||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||298.45|-14.62|0.0747
70860239|NCT01227564|141206982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|204.4||||0.0151|TWO_SIDED|95.0|41.02|367.79||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||367.79|41.02|0.0151
70860240|NCT01227564|141206982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|173.16||||0.0161|TWO_SIDED|95.0|33.25|313.07||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||313.07|33.25|0.0161
70947149|NCT00497874|141394776|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.003||95.0||||Statistical significance of the pooled results was evaluated using a t-test and degrees of freedom that take into account the uncertainty in the data and the uncertainty due to missing values.|t-test, 1 sided|t(145) = 2.8||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology-in this case, the t-test-and the results pooled.||||.003
70947150|NCT00497874|141394777|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.002||95.0||||Statistical significance of the pooled results was evaluated using a t-test and degrees of freedom that take into account the uncertainty in the data and the uncertainty due to missing values.|t-test, 1 sided|t(181) = 2.9||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology-in this case, logistic regression-and the results pooled.||||.002
70860241|NCT01227564|141206983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.652||||0.1807|TWO_SIDED|95.0|-6.57|1.267||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||1.267|-6.570|0.1807
70860242|NCT01227564|141206983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.497||||0.8051|TWO_SIDED|95.0|-3.515|4.508||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||4.508|-3.515|0.8051
70872054|NCT02155608|141229483|SUPERIORITY|||||||0.05||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = 4.18, df = 1/57.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.05
70872055|NCT02155608|141229483|SUPERIORITY|||||||0.73||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .12, df = 1/57.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.73
70860243|NCT01227564|141206983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.078||||0.5331|TWO_SIDED|95.0|-4.519|2.364||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||2.364|-4.519|0.5331
70860244|NCT01227564|141206983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.174||||0.9274|TWO_SIDED|95.0|-3.99|3.641||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||3.641|-3.990|0.9274
70860245|NCT01227564|141206983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.549||||0.0743|TWO_SIDED|95.0|-0.36|7.458||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||7.458|-0.360|0.0743
70860246|NCT01227564|141206983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.687||||0.3163|TWO_SIDED|95.0|-1.656|5.031||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||5.031|-1.656|0.3163
70860247|NCT01227564|141206983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.645||||0.519|TWO_SIDED|95.0|-6.721|3.43||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||3.430|-6.721|0.5190
70860248|NCT01227564|141206983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.758||||0.074|TWO_SIDED|95.0|-0.476|9.991||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||9.991|-0.476|0.0740
70860249|NCT01227564|141206983|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5.394||||0.4909|TWO_SIDED|95.0|-2.937|6.049||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||6.049|-2.937|0.4909
70872056|NCT02155608|141229484|SUPERIORITY|||||||0.003||||||p \< .05 for statistical significance|Chi-squared|Group: F = 8.75, df = 1/168.||Phase 1a: Assessed effects of group and time on categorical measure CGI-I from Baseline through Visit 4.||||.003
70872057|NCT02155608|141229484|SUPERIORITY|||||||0.17||||||p \< .05 for statistical significance.|Chi-squared|Time: F = 1.69, df = 3/168.||Phase 1a: Assessed effects of group and time on categorical measure CGI-I from Baseline through Visit 4.||||.17
70947151|NCT00497874|141394778|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.04||95.0||||Statistical significance of the pooled results was evaluated using a t-test and degrees of freedom that take into account the uncertainty in the data and the uncertainty due to missing values.|t-test, 1 sided|t(153) = 1.8||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology-in this case, logistic regression-and the results pooled.||||.04
70947152|NCT00497874|141394779|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.07||95.0||||Statistical significance of the pooled results was evaluated using a t-test and degrees of freedom that take into account the uncertainty in the data and the uncertainty due to missing values.|t-test, 1 sided|t(57) = 1.5||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology-in this case, logistic regression-and the results pooled.||||.07
70860250|NCT01227564|141206983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.383||||0.9151|TWO_SIDED|95.0|-7.549|6.783||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||6.783|-7.549|0.9151
70860251|NCT01227564|141206983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.394||||0.1533|TWO_SIDED|95.0|-2.069|12.857||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||12.857|-2.069|0.1533
70860252|NCT01227564|141206983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.506||||0.4371|TWO_SIDED|95.0|-3.904|8.915||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||8.915|-3.904|0.4371
70860253|NCT01227564|141206983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.21||||0.6167|TWO_SIDED|95.0|-10.999|6.579||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||6.579|-10.999|0.6167
70860254|NCT01227564|141206983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.11||||0.1844|TWO_SIDED|95.0|-2.993|15.212||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||15.212|-2.993|0.1844
70860255|NCT01227564|141206983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.95||||0.6205|TWO_SIDED|95.0|-5.888|9.878||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||9.878|-5.888|0.6205
70860256|NCT01227564|141206984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.418||||0.1695|TWO_SIDED|95.0|-0.183|1.018||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||1.018|-0.183|0.1695
70860257|NCT01227564|141206984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147||||0.6331|TWO_SIDED|95.0|-0.465|0.759||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.759|-0.465|0.6331
70860258|NCT01227564|141206984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.282||||0.2907|TWO_SIDED|95.0|-0.247|0.812||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.812|-0.247|0.2907
70860259|NCT01227564|141206984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007||||0.9846|TWO_SIDED|95.0|-0.675|0.688||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.688|-0.675|0.9846
70860260|NCT01227564|141206984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.304||||0.3845|TWO_SIDED|95.0|-1.0|0.392||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.392|-1.000|0.3845
70860261|NCT01227564|141206984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.149||||0.6204|TWO_SIDED|95.0|-0.748|0.45||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.450|-0.748|0.6204
70860262|NCT01227564|141206984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.014||||0.981|TWO_SIDED|95.0|-1.221|1.192||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||1.192|-1.221|0.9810
70860263|NCT01227564|141206984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.796||||0.2034|TWO_SIDED|95.0|-2.034|0.443||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.443|-2.034|0.2034
70860264|NCT01227564|141206984|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.405||||0.4491|TWO_SIDED|95.0|-1.469|0.659||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.659|-1.469|0.4491
70860265|NCT01227564|141206984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.255||||0.8074|TWO_SIDED|95.0|-1.827|2.337||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||2.337|-1.827|0.8074
70860266|NCT01227564|141206984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.029||||0.3444|TWO_SIDED|95.0|-3.189|1.131||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||1.131|-3.189|0.3444
70860267|NCT01227564|141206984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.387||||0.6772|TWO_SIDED|95.0|-2.239|1.464||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||1.464|-2.239|0.6772
70860268|NCT01227564|141206984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.652||||0.6325|TWO_SIDED|95.0|-2.063|3.367||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||3.367|-2.063|0.6325
70860269|NCT01227564|141206984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.5706|TWO_SIDED|95.0|-3.606|2.007||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.007|-3.606|0.5706
70860270|NCT01227564|141206984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.074||||0.9513|TWO_SIDED|95.0|-2.485|2.337||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.337|-2.485|0.9513
70860271|NCT01227564|141206985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015||||0.6054|TWO_SIDED|95.0|-0.074|0.043||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.043|-0.074|0.6054
70860272|NCT01227564|141206985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.025||||0.4087|TWO_SIDED|95.0|-0.035|0.084||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.084|-0.035|0.4087
70860273|NCT01227564|141206985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005||||0.8518|TWO_SIDED|95.0|-0.046|0.056||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.056|-0.046|0.8518
70860274|NCT01227564|141206985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025||||0.4216|TWO_SIDED|95.0|-0.085|0.036||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.036|-0.085|0.4216
70860275|NCT01227564|141206985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.034||||0.273|TWO_SIDED|95.0|-0.028|0.097||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.097|-0.028|0.2730
70860276|NCT01227564|141206985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005||||0.8549|TWO_SIDED|95.0|-0.048|0.058||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.058|-0.048|0.8549
70860277|NCT01227564|141206985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.026||||0.5847|TWO_SIDED|95.0|-0.12|0.068||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.068|-0.120|0.5847
71131047|NCT03688074|141765849|OTHER||Ratio of Geometric LSMeans|0.83||||0.26|TWO_SIDED|90.0|0.64|1.09||Nominal p-values were reported. No adjustment of multiplicity was performed.|ANCOVA|Model includes treatment+log transformed baseline value+stratification factor (screening eos count \[\<150, 150-\<300, \>=300 cells/uL\])|Parameter: Mast cells Tryptase+ (cells/mm\^2)||95% CI (0.61, 1.15)|1.09|0.64|0.260
70860278|NCT01227564|141206985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.067||||0.174|TWO_SIDED|95.0|-0.03|0.163||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.163|-0.030|0.1740
70872058|NCT02155608|141229484|SUPERIORITY|||||||0.46|||||||Chi-squared|Group: Chi-square = .53, df = 1.||Phase 1b: Assessed effects of group on categorical measure CGI-I from at Visit 5 compared to baseline.||||.46
71131048|NCT03688074|141765849|OTHER||Ratio of Geometric LSMeans|1.19||||0.546|TWO_SIDED|90.0|0.74|1.92||Nominal p-values were reported. No adjustment of multiplicity was performed.|ANCOVA|Model includes treatment+log transformed baseline value+stratification factor (screening eos count \[\<150, 150-\<300, \>=300 cells/uL\])|Parameter: Mast cells Chymase+ (cells/mm\^2)||95% CI (0.67, 2.10)|1.92|0.74|0.546
71131049|NCT03928717|141765866|SUPERIORITY||Mean Difference (Final Values)|0.01|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
71131050|NCT03928717|141765867|SUPERIORITY||Mean Difference (Final Values)|0.16|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
71131051|NCT05224453|141765896|SUPERIORITY|Parametric t test|Mean Difference (Final Values)|-5.0|||<|0.05|TWO_SIDED|95.0|-6.21|-3.78|||t-test, 2 sided|||||-3.78|-6.21|<0.05
70860279|NCT01227564|141206985|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.02||||0.6255|TWO_SIDED|95.0|-0.063|0.103||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.103|-0.063|0.6255
70860280|NCT01227564|141206985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023||||0.7658|TWO_SIDED|95.0|-0.177|0.131||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.131|-0.177|0.7658
70860281|NCT01227564|141206985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079||||0.3309|TWO_SIDED|95.0|-0.082|0.24||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.240|-0.082|0.3309
70860282|NCT01227564|141206985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028||||0.6872|TWO_SIDED|95.0|-0.11|0.166||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.166|-0.110|0.6872
70860283|NCT01227564|141206985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003||||0.9752|TWO_SIDED|95.0|-0.196|0.202||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.202|-0.196|0.9752
70860284|NCT01227564|141206985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143||||0.1715|TWO_SIDED|95.0|-0.064|0.349||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.349|-0.064|0.1715
70860285|NCT01227564|141206985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073||||0.4145|TWO_SIDED|95.0|-0.105|0.25||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.250|-0.105|0.4145
70947153|NCT00497874|141394780|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.05||95.0|||||t-test, 1 sided|t(94) = 1.5||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology-in this case, logistic regression-and the results pooled.||||.05
71131052|NCT05224453|141765897|SUPERIORITY|Parametric t test|Mean Difference (Final Values)|-3.7|||<|0.05|TWO_SIDED|95.0|-6.53|-0.86|||t-test, 2 sided|||||-0.86|-6.53|<0.05
70947154|NCT00497874|141394781|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.13||95.0||||Statistical significance of the pooled results was evaluated using a t-test and degrees of freedom that take into account the uncertainty in the data and the uncertainty due to missing values.|t-test, 1 sided|t(123) = 1.2||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology-in this case, the t-test-and the results pooled.||||.13
71131053|NCT05224453|141765897|SUPERIORITY|Parametric t test|Mean Difference (Final Values)|-1.7|||<|0.05|TWO_SIDED|95.0|-3.84|0.44|||t-test, 2 sided|||||0.44|-3.84|<0.05
71131054|NCT01128244|141765900|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED|||||Threshold for significance P\<0.05|t-test, 2 sided|Paired t-test||||||0.20
71131055|NCT01128244|141765901|SUPERIORITY_OR_OTHER|||||||0.62|TWO_SIDED|||||Threshold for significance, P\<0.05|t-test, 2 sided|Paired t-test||||||0.62
71131056|NCT01128244|141765902|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Threshold for significance, P\<0.05|t-test, 2 sided|Paired t-test||||||<0.001
71131057|NCT01128244|141765903|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED|||||Threshold for significance, P\<0.05|t-test, 2 sided|Paired t-test||||||0.45
70947155|NCT00004146|141394824|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.1|TWO_SIDED|95.0|0.65|1.12|||t-test, 1 sided|||the study design is to detect 30% reduction in hazard of deaths with 78% power at one side alpha level of 0.10. Overall survial time was calculated from time of histological diagnosis until time of death from any event.||1.12|0.65|0.10
71131058|NCT01128244|141765904|SUPERIORITY_OR_OTHER||Test of treatment effect.|0.05|||<|0.05|TWO_SIDED|||||Data were analyzed by paired t-test adjusted for multiple testing by Sidak methods.|t-test, 2 sided|||Data were analyzed by paired t-test adjusted for multiple testing by Sidak methods.||||<0.05
71131059|NCT02219334|141765908|EQUIVALENCE|Historical data at the institution for similar patients had a mean length of stay(LOS) of 25.7 hours (standard deviation-\[SD\] =10.3) from 9/2012- 9/13 was observed for 134 patients admitted to the emergency department observation unit and treated with the standard of care (NeoSucker). Given a LOS-SD of 10.3 hours, 75 subjects per treatment group would provide 80% statistical power at the 5% significance level to demonstrate equivalence in the two treatments' length of stay within ±5 hours.|Mean Difference (Final Values)|2.49|STANDARD_DEVIATION|21.4|<|0.05|TWO_SIDED|95.0|-10.74|15.72|||two one-sided t-test (TOST)||Due to slower than anticipated patient recruitment, the target size of 75 participants per treatment group was not reached.|The primary hypothesis of length of stay equivalence within a margin of ± 5 hours was tested using the two one-sided t-test (TOST) procedure, with a 5% significance level.||15.72|-10.74|<0.05
71131060|NCT02381015|141765942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Chi-squared|||||||0.29
71131061|NCT02381015|141765943|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35|||||||Chi-squared|||||||0.35
71131062|NCT02381015|141765944|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Chi-squared|||||||0.29
71131063|NCT02381015|141765945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.49|||||||Kruskal-Wallis|||||||0.49
71131064|NCT02381015|141765946|OTHER||Beta|93.5|STANDARD_ERROR_OF_MEAN|1.55||0.42|TWO_SIDED||||||ANOVA|||The statistical analysis shows the relation between risk given and risk recall at the immediate post results assessment for the total number of participants.||||0.42
71131065|NCT02381015|141765947|OTHER||Beta|94.7|STANDARD_ERROR_OF_MEAN|2.93||0.33|TWO_SIDED||||||ANOVA|||||||0.33
71131066|NCT01934010|141765948|SUPERIORITY|||||||0.128|||||||Fisher Exact|||Fisher's exact test to assess if there is a difference in deterioration of hearing threshold between subjects that received 1 treatment cycle with AM-101 or others who received 2 treatment cycles.||||0.128
71131067|NCT01934010|141765948|SUPERIORITY|||||||0.075|||||||Fisher Exact|||Fisher's exact test to assess if there is a difference in deterioration of hearing threshold between subjects that received 1 treatment cycle with AM-101 or others who received 3 treatment cycles.||||0.075
71131068|NCT01934010|141765948|SUPERIORITY|||||||1|||||||Fisher Exact|||Fisher's exact test to assess if there is a difference in deterioration of hearing threshold between subjects that received 2 treatment cycles with AM-101 or others who received 3 treatment cycles.||||1
71131069|NCT01934010|141765949|SUPERIORITY|||||||0.4403|||||||Fisher Exact|||||||0.4403
71131070|NCT01934010|141765951|SUPERIORITY|||||||0.2401|||||||Fisher Exact|||||||0.2401
71131071|NCT01934010|141765951|SUPERIORITY|||||||0.0022|||||||Fisher Exact|||||||0.0022
71131072|NCT01934010|141765951|SUPERIORITY|||||||0.1001|||||||Fisher Exact|||||||0.1001
71131073|NCT01934010|141765952|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71131074|NCT01393821|141765954|SUPERIORITY|||||||0.6311|||||||Kruskal-Wallis|||||||0.6311
70860286|NCT01227564|141206986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.011||||0.5134|TWO_SIDED|95.0|-0.043|0.022||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.022|-0.043|0.5134
71131075|NCT03422536|141765958|EQUIVALENCE|The pre-specified significance criteria were met by exclusion of the historical control PFS of 2.0 months. As confirmation, the one-sample log rank test was computed with expected survival estimated using an exponential distribution of 2.0 months.||||||0.04||||||The a priori threshold for statistical significance is \<.05|Log Rank|||||||.04
71131076|NCT03422536|141765963|SUPERIORITY|||||||0.005|||||||Regression, Cox|||c-Met positivity was compared across groups: HPV+ vs HPV-||||.005
71131077|NCT03422536|141765963|SUPERIORITY||Cox Proportional Hazard|0.3||||0.02|TWO_SIDED|95.0|0.1|0.8|||Log Rank|||Post-hoc comparison of progression free survival (PFS) in cMet positive vs. c-Met negative patients.||0.8|0.1|.02
71131078|NCT03422536|141765963|SUPERIORITY||Cox Proportional Hazard|0.1||||0.03|TWO_SIDED|95.0|0.03|0.8|||Log Rank|||Post hoc comparison of PFS in the combination arm by HPV subgroup, adjusted for prognostic factors marginally associated with HPV status (P , .10), was assessed using Cox proportional hazards models. Here we are looking at cMet positivity in HPV- patients in the combination arm.||0.8|0.03|0.03
71131079|NCT03422536|141765963|SUPERIORITY||Cox Proportional Hazard|3.2||||0.2|TWO_SIDED|95.0|0.6|17.5|||Log Rank|||Post hoc comparison of PFS in the combination arm by HPV subgroup, adjusted for prognostic factors marginally associated with HPV status (P , .10), was assessed using Cox proportional hazards models. Here we are looking at cMet positivity in HPV+ patients in the combination arm.||17.5|0.6|.20
71131080|NCT03422536|141765963|SUPERIORITY||Cox Proportional Hazard|1.4||||0.1|TWO_SIDED|95.0|0.9|2.0|||Log Rank|||Post-hoc comparison of progression free survival (PFS) in HGF positive vs. HGF negative patients.||2.0|0.9|.10
71131081|NCT03422536|141765963|SUPERIORITY||Cox Proportional Hazard|1.4||||0.6|TWO_SIDED|95.0|0.4|4.7|||Log Rank|||Post hoc comparison of PFS in the combination arm by HPV subgroup, adjusted for prognostic factors marginally associated with HPV status (P , .10), was assessed using Cox proportional hazards models. Here we are looking at HGF expression in HPV- patients in the combination arm.||4.7|0.4|.60
71131082|NCT03422536|141765963|SUPERIORITY||Cox Proportional Hazard|3.4||||0.07|TWO_SIDED|95.0|0.9|13.1|||Log Rank|||Post hoc comparison of PFS in the combination arm by HPV subgroup, adjusted for prognostic factors marginally associated with HPV status (P \< .10), was assessed using Cox proportional hazards models. Here we are looking at HGF expression in HPV+ patients in the combination arm.||13.1|0.9|.07
71131083|NCT04929249|141765967|SUPERIORITY||LS mean difference|-53.0|||<|0.001|TWO_SIDED|97.5|-60.0|-46.0|||Mixed Models Analysis|||||-46.0|-60.0|<0.001
71131084|NCT04929249|141765968|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the one-sided 98.75% confidence interval did not exceed the non-inferiority margin of 15%.|Difference in percentage|-10.6|||||TWO_SIDED|97.5|-18.3|-3.0|||Normal approx. to binomial distribution||||Upper limit of one-sided 98.75% CI (-3.0%)|-3.0|-18.3|
71131085|NCT04929249|141765969|SUPERIORITY||LS mean difference|-47.6|||<|0.001|TWO_SIDED|95.0|-52.8|-42.3|||Mixed Models Analysis|||||-42.3|-52.8|<0.001
71131086|NCT04929249|141765970|SUPERIORITY||LS mean difference|-54.4|||<|0.001|TWO_SIDED|95.0|-59.0|-49.8|||Regression, Linear|||||-49.8|-59.0|<0.001
71131087|NCT04929249|141765971|SUPERIORITY||LS mean difference|-48.9|||<|0.001|TWO_SIDED|95.0|-52.9|-44.9|||Regression, Linear|||||-44.9|-52.9|<0.001
71131088|NCT04929249|141765972|SUPERIORITY||Odds Ratio (OR)|42.32|||<|0.001|TWO_SIDED|95.0|22.07|81.16|||Regression, Logistic|||||81.16|22.07|<0.001
71131089|NCT04929249|141765973|SUPERIORITY||Odds Ratio (OR)|17.32|||<|0.001|TWO_SIDED|95.0|6.72|44.66|||Regression, Logistic|||||44.66|6.72|<0.001
71131090|NCT04929249|141765974|SUPERIORITY||Odds Ratio (OR)|24.46|||<|0.001|TWO_SIDED|95.0|14.18|42.19|||Regression, Logistic|||||42.19|14.18|<0.001
71131091|NCT04929249|141765975|SUPERIORITY||Odds Ratio (OR)|35.12|||<|0.001|TWO_SIDED|95.0|19.51|63.24|||Regression, Logistic|||||63.24|19.51|<0.001
71131092|NCT04929249|141765976|SUPERIORITY||LS mean difference|-30.1|||<|0.001|TWO_SIDED|95.0|-33.8|-26.3|||Mixed Models Analysis|||Total Cholesterol||-26.3|-33.8|<0.001
71131093|NCT04929249|141765976|SUPERIORITY||LS mean difference|6.6|||<|0.001|TWO_SIDED|95.0|3.6|9.5|||Mixed Models Analysis|||HDL Cholesterol||9.5|3.6|<0.001
71131094|NCT04929249|141765976|SUPERIORITY||LS mean difference|-44.2|||<|0.001|TWO_SIDED|95.0|-49.1|-39.3|||Mixed Models Analysis|||Non-HDL Cholesterol||-39.3|-49.1|<0.001
71131095|NCT04929249|141765976|SUPERIORITY||LS mean difference|-16.9|||<|0.001|TWO_SIDED|95.0|-23.8|-10.0|||Mixed Models Analysis|||VLDL Cholesterol||-10.0|-23.8|<0.001
71131096|NCT04929249|141765976|SUPERIORITY||LS mean difference|-17.8|||<|0.001|TWO_SIDED|95.0|-24.7|-10.9|||Mixed Models Analysis|||Triglycerides||-10.9|-24.7|<0.001
71131097|NCT04929249|141765976|SUPERIORITY||LS mean difference|-42.6|||<|0.001|TWO_SIDED|95.0|-47.5|-37.8|||Mixed Models Analysis|||Apolipoprotein B||-37.8|-47.5|<0.001
71131098|NCT04929249|141765976|SUPERIORITY||LS mean difference|-21.9|||<|0.001|TWO_SIDED|95.0|-25.8|-18.0|||Mixed Models Analysis|||Lipoprotein(a)||-18.0|-25.8|<0.001
71131099|NCT04929249|141765977|SUPERIORITY||LS mean difference|-49.9|||<|0.001|TWO_SIDED|95.0|-56.0|-43.9|||Mixed Models Analysis|||Total Cholesterol||-43.9|-56.0|<0.001
71131100|NCT04929249|141765977|SUPERIORITY||LS mean difference|3.1|||<|0.001|TWO_SIDED|95.0|1.8|4.4|||Mixed Models Analysis|||HDL Cholesterol||4.4|1.8|<0.001
71131101|NCT04929249|141765977|SUPERIORITY||LS mean difference|-52.4|||<|0.001|TWO_SIDED|95.0|-58.1|-46.7|||Mixed Models Analysis|||Non-HDL Cholesterol||-46.7|-58.1|<0.001
71131102|NCT04929249|141765977|SUPERIORITY||LS mean difference|-4.6|||<|0.001|TWO_SIDED|95.0|-6.5|-2.8|||Mixed Models Analysis|||VLDL Cholesterol||-2.8|-6.5|<0.001
71131103|NCT04929249|141765977|SUPERIORITY||LS mean difference|-25.3|||<|0.001|TWO_SIDED|95.0|-34.8|-15.8|||Mixed Models Analysis|||Triglycerides||-15.8|-34.8|<0.001
71131104|NCT04929249|141765977|SUPERIORITY||LS mean difference|-36.3|||<|0.001|TWO_SIDED|95.0|-39.7|-32.9|||Mixed Models Analysis|||Apolipoprotein B||-32.9|-39.7|<0.001
70860287|NCT01227564|141206986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008||||0.6083|TWO_SIDED|95.0|-0.024|0.041||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.041|-0.024|0.6083
70860288|NCT01227564|141206986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001||||0.9401|TWO_SIDED|95.0|-0.029|0.027||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.027|-0.029|0.9401
70860289|NCT01227564|141206986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.018||||0.295|TWO_SIDED|95.0|-0.051|0.016||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.016|-0.051|0.2950
70860290|NCT01227564|141206986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003||||0.8817|TWO_SIDED|95.0|-0.031|0.037||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.037|-0.031|0.8817
70860291|NCT01227564|141206986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008||||0.6072|TWO_SIDED|95.0|-0.037|0.022||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.022|-0.037|0.6072
70860292|NCT01227564|141206986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012||||0.6259|TWO_SIDED|95.0|-0.06|0.036||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.036|-0.060|0.6259
70860293|NCT01227564|141206986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.027||||0.2807|TWO_SIDED|95.0|-0.023|0.076||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.076|-0.023|0.2807
70860294|NCT01227564|141206986|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.008||||0.7224|TWO_SIDED|95.0|-0.035|0.05||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.050|-0.035|0.7224
70872059|NCT02155608|141229485|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|Group: F=.01; df =1/209.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||.91
71131105|NCT04929249|141765977|SUPERIORITY||LS mean difference|-8.7|||<|0.001|TWO_SIDED|95.0|-10.7|-6.8|||Mixed Models Analysis|||Lipoprotein(a)||-6.8|-10.7|<0.001
71131106|NCT04929249|141765978|SUPERIORITY||Odds Ratio (OR)|1.06||||0.899|TWO_SIDED|95.0|0.43|2.61|||proportional odds model|||||2.61|0.43|0.899
71131107|NCT04929249|141765979|SUPERIORITY||LS mean difference|-0.008||||0.727|TWO_SIDED|95.0|-0.055|0.039|||Regression, Linear|||||0.039|-0.055|0.727
71131108|NCT00395850|141765990|SUPERIORITY_OR_OTHER||Slope|-1.02|||<|0.05|||||||Repeated Measures Logistic Regression|Repeated Measures Generalized Linear Models on a Binomial distribution, thus a Repeated Measures Logistic Regression||Used placebo group as contrast to determine whether slopes of disulfiram groups differed from slope of placebo group data||||<0.05
71131109|NCT00395850|141765991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
71131110|NCT02910102|141766009|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.3565|TWO_SIDED|95.0|-6.04|2.23||The threshold for statistical significance was p=0.05|Mixed Models Analysis|Each co-primary endpoint was tested at two-sided 5% level of significance, with no adjustments for multiplicity.||||2.23|-6.04|0.3565
71131111|NCT02910102|141766010|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.922|TWO_SIDED|95.0|-3.73|3.38||The threshold for statistical significance was p=0.05|Mixed Models Analysis|Each co-primary endpoint was tested at two-sided 5% level of significance, with no adjustments for multiplicity.||||3.38|-3.73|0.9220
71131112|NCT02669121|141766011|SUPERIORITY||Cox Proportional Hazard|0.8|||||TWO_SIDED|99.99|-13.181|0.997|||||||The vaccine efficacy was met if lower bound of confidence interval (CI) for vaccine efficacy was above 0. Vaccine efficacy (VE) was defined as 1-(hazard rate for NoV vaccine arm / hazard rate for placebo arm), where the hazard ratio is from the Cox proportional hazard (PH) model. The 99.99% CI for the VE was obtained by taking 1 minus the 99.99% CI of the hazard ratio from the PH model.|0.997|-13.181|
71131113|NCT02669121|141766012|SUPERIORITY||Cox Proportional Hazard|0.618|||||TWO_SIDED|95.01|0.208|0.816|||||||The vaccine efficacy was met if lower bound of CI for vaccine efficacy was above 0. Vaccine efficacy (VE) was defined as 1-(hazard rate for NoV vaccine arm / hazard rate for placebo arm), where the hazard ratio is from the PH model. The 95.01% CI for the VE was obtained by taking 1 minus the 95.01% CI of the hazard ratio from the PH model.|0.816|0.208|
71131114|NCT02669121|141766013|SUPERIORITY||Cox Proportional Hazard|0.618|||||TWO_SIDED|95.0|0.208|0.816|||||||The vaccine efficacy was met if lower bound of CI for vaccine efficacy was above 0. Vaccine efficacy (VE) was defined as 1-(hazard rate for NoV vaccine arm / hazard rate for placebo arm), where the hazard ratio is from the PH model. The 95% CI for the VE was obtained by taking 1 minus the 95% CI of the hazard ratio from the PH model.|0.816|0.208|
71131115|NCT02669121|141766014|SUPERIORITY||Cox Proportional Hazard|0.8|||||TWO_SIDED|95.0|-0.711|0.977|||||||The vaccine efficacy was met if lower bound of CI for vaccine efficacy was above 0. Vaccine efficacy (VE) was defined as 1-(hazard rate for NoV vaccine arm / hazard rate for placebo arm), where the hazard ratio is from the PH model. The 95% CI for the VE was obtained by taking 1 minus the 95% CI of the hazard ratio from the PH model.|0.977|-0.711|
70860295|NCT01227564|141206986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007||||0.8532|TWO_SIDED|95.0|-0.08|0.067||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.067|-0.080|0.8532
71131116|NCT00241904|141766026|SUPERIORITY||||||<|0.001|||||||General Linear Mixed Model|||Intention to treat analysis was used||||<0.001
71131117|NCT00241904|141766027|SUPERIORITY|||||||0.003|||||||General Linear Mixed Model|||||||0.003
71131118|NCT00241904|141766028|SUPERIORITY|||||||0.034|||||||General Linear Mixed Model|||||||0.034
71131119|NCT00241904|141766029|SUPERIORITY||||||<|0.001|||||||General Linear Mixed Model|||||||<0.001
71131120|NCT00825812|141766041|SUPERIORITY_OR_OTHER||ratio of geometric mean time to recovery|5.7||||||95.0|4.9|6.6|||ANOVA|ANOVA, adjusted for center effects, on log transformed times from start of administration of IMP to recovery of the T4/T1 ratio to 0.9.|Ratio of time to recovery of 0.9 T4/T1 ratio (neostigmine time / sugammadex time).|The primary analysis was the comparison of the two treatments among Chinese subjects.||6.6|4.9|
71131121|NCT00825812|141766041|SUPERIORITY_OR_OTHER||ratio of geometric mean time to recovery|4.8||||||97.5|3.7|6.0|||ANOVA|ANOVA, adjusted for center effects, on log transformed times from start of administration of IMP to recovery of the T4/T1 ratio to 0.9.|Ratio of time to recovery of 0.9 T4/T1 ratio (neostigmine time / sugammadex time).|A key secondary analysis was the comparison of the two treatments among Caucasian subjects.||6.0|3.7|
70860296|NCT01227564|141206986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039||||0.3116|TWO_SIDED|95.0|-0.038|0.116||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.116|-0.038|0.3116
71131122|NCT00825812|141766041|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was considered if the 97.5% confidence interval (CI) for median difference in recovery time (T4/T1 ratio to 0.9) was within the pre-specified range of -60 to +60 seconds.|median difference (seconds)|7.0||||||97.5|-5.0|21.0|||||Estimated median difference (Chinese - Caucasian) in seconds for the time to recovery of the T4/T1 ratio to 0.9 (after sugammadex).|A key secondary analysis was the comparison for equivalence between Chinese subjects and Caucasian subjects.||21|-5|
71131123|NCT00483938|141766043|SUPERIORITY_OR_OTHER|||||||0.51|||||||Fisher Exact|||SVR: Group A versus Group B||||0.510
70860297|NCT01227564|141206986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016||||0.6246|TWO_SIDED|95.0|-0.049|0.082||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.082|-0.049|0.6246
71131124|NCT00483938|141766044|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||SVR: Group C versus Group D||||1.000
71131125|NCT00483938|141766044|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||SVR: Group E versus Group F||||1.000
71131126|NCT00483938|141766045|SUPERIORITY_OR_OTHER|||||||0.792|||||||Fisher Exact|||ETR: Group A versus Group B||||0.792
71131127|NCT00483938|141766045|SUPERIORITY_OR_OTHER|||||||0.612|||||||Fisher Exact|||ETR: Group C versus Group D||||0.612
71131128|NCT00483938|141766045|SUPERIORITY_OR_OTHER|||||||0.49|||||||Fisher Exact|||ETR: Group E versus Group F||||0.490
71131129|NCT00483938|141766045|SUPERIORITY_OR_OTHER|||||||0.363|||||||Fisher Exact|||Complete EVR: Group C versus Group D||||0.363
71131130|NCT00483938|141766045|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Complete EVR: Group E versus Group F||||1.000
71131131|NCT02218008|141766046|SUPERIORITY||Least Squares Mean Difference|-1.5||||0.018|TWO_SIDED|95.0|-2.7|-0.3||Hypothesis tests were two-sided with an alpha of 0.05. Control of type 1 error inflation due to multiplicity was achieved by pre-specifying a fixed sequence for statistical tests.|Mixed Models Analysis|ALKS 5461 was compared to pbo using stage-specific MMRM for MADRS-10 Change from Baseline. Model-derived estimates were combined using equal weights.|Estimates below zero favor ALKS 5461.|Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 2mg/2mg was compared to placebo (i.e., ALKS 5461 2mg/2mg S1 vs Placebo S1; and ALKS 5461 2mg/2mg S2 vs Placebo S2. The pre-specified order of hypothesis tests was ALKS 5461 2/2 compared to placebo followed by ALKS 5461 1/1 compared to placebo.||-0.3|-2.7|0.018
71131132|NCT02218008|141766047|SUPERIORITY|Hypothesis tests were two-sided with an alpha of 0.05. Control of type 1 error inflation due to multiplicity was achieved by pre-specifying a fixed sequence for statistical tests.|Least Squares Mean Difference|-1.9||||0.026|TWO_SIDED|95.0|-3.6|-0.2||ALKS 5461 was compared to pbo using stage-specific MMRM for MADRS-10 Change from Baseline. Model-derived estimates were combined using equal weights.|Mixed Models Analysis||Estimates below zero favor ALKS 5461.|Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 2mg/2mg was compared to placebo (i.e., ALKS 5461 2mg/2mg S1 vs Placebo S1; and ALKS 5461 2mg/2mg S2 vs Placebo S2. The pre-specified order of hypothesis tests was ALKS 5461 2/2 compared to placebo followed by ALKS 5461 1/1 compared to placebo.||-0.2|-3.6|0.026
71131133|NCT02218008|141766048|SUPERIORITY|The primary hypotheses were evaluated using a 6-step, fixed sequence approach to adjust for multiple comparisons. Using this method, hypothesis testing (using alpha=0.05) continued through the sequence until statistical significance was not achieved. Steps 1-3 included testing the ALKS 5461 2mg/2mg dose vs placebo for the 3 primary endpoints.|Least Squares Mean Difference|-1.7||||0.076|TWO_SIDED|95.0|-3.6|0.2||ALKS 5461 is compared to placebo within each of the 2 stages, and resulting treatment effects from each stage are combined for a single hypothesis test using equal weights of 0.5 for both stages.|Mixed Models Analysis|||ALKS 5461 is compared to placebo within each of the 2 stages (i.e., ALKS 5461 2/2 S1 vs Placebo S1; and ALKS 5461 2/2 S2 vs Placebo S2). Efficacy was estimated as a weighted average across 2 stages using equal weights.||0.2|-3.6|0.076
71131134|NCT02038075|141766090|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.38||||0.02|TWO_SIDED|95.0|0.16|0.87|||Regression, Cox|||To determine the effectiveness of brief CBT compared with treatment as usual, univariate and multivariate Cox proportional hazard regression models were used to analyze time to the first suicide attempt. Time to suicide attempt was measured by calculating the total number of days from enrollment to the first suicide attempt. For participants without a suicide attempt, the total number of days from enrollment to the last assessment was calculated.||.87|.16|.02
71131135|NCT04000581|141766100|SUPERIORITY|||||||0.329|||||||t-test, 1 sided|||The null hypothesis is that the mean change is equal between the groups, while the alternative is that an increased difference is observed in arm 2. The hypotheses are evaluated using a one-sided, two-sample t-test.||||0.329
71131136|NCT00588354|141766111|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.54|STANDARD_ERROR_OF_MEAN|1.05||0.159|TWO_SIDED|95.0|-0.52|3.6|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||3.60|-0.52|0.159
71131137|NCT00588354|141766112|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.97||0.91|TWO_SIDED|95.0|-1.79|2.01|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||2.01|-1.79|0.910
70860298|NCT01227564|141206986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008||||0.8697|TWO_SIDED|95.0|-0.092|0.108||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.108|-0.092|0.8697
71131138|NCT00588354|141766113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.96|STANDARD_ERROR_OF_MEAN|2.04||0.162|TWO_SIDED|95.0|-1.04|6.96|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||6.96|-1.04|0.162
70947156|NCT02808975|141394827|SUPERIORITY||||||=|0.049|||||||Cochran-Mantel-Haenszel|Across all strata, P-value calculated from Cochran-Mantel-Haenszel test adjusted for strata. Stratum containing zero count: 0.1 added to each cell.||||||=0.049
71131139|NCT00588354|141766114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.67|STANDARD_ERROR_OF_MEAN|2.27||0.022|TWO_SIDED|95.0|1.22|10.12|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||10.12|1.22|0.022
71131140|NCT00588354|141766115|SUPERIORITY_OR_OTHER||Median Difference (Net)|5.86|STANDARD_ERROR_OF_MEAN|3.28||0.089|TWO_SIDED|95.0|-0.57|12.29|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||12.29|-0.57|0.089
71131141|NCT00588354|141766116|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.04|STANDARD_ERROR_OF_MEAN|3.17||0.038|TWO_SIDED|95.0|0.83|13.25|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||13.25|0.83|0.038
71131142|NCT00588354|141766117|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.83|STANDARD_ERROR_OF_MEAN|3.53||0.186|TWO_SIDED|95.0|-11.75|2.09|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||2.09|-11.75|0.186
71131143|NCT00588354|141766118|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35|STANDARD_ERROR_OF_MEAN|3.37||0.918|TWO_SIDED|95.0|-6.96|6.26|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||6.26|-6.96|0.918
71131144|NCT02519595|141766122|SUPERIORITY_OR_OTHER|||||||0.2|||||||Kruskal-Wallis|||||||0.2
71131145|NCT02519595|141766123|SUPERIORITY_OR_OTHER|||||||0.09|||||||Kruskal-Wallis|||||||0.09
71131146|NCT02519595|141766124|SUPERIORITY_OR_OTHER|||||||0.2|||||||Kruskal-Wallis|||||||0.2
71131147|NCT02519595|141766126|SUPERIORITY_OR_OTHER|||||||0.8|||||||Chi-squared|||Adverse events in ED||||0.8
71131148|NCT02519595|141766126|SUPERIORITY_OR_OTHER|||||||0.5|||||||Chi-squared|||Post discharge Emesis||||0.5
71131149|NCT02519595|141766127|SUPERIORITY_OR_OTHER|||||||0.011|||||||Chi-squared|||||||0.011
71131150|NCT00387036|141766128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.37||||90.0|-1.59|-0.25||||||||-0.25|-1.59|
71131151|NCT00387036|141766129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.17|STANDARD_ERROR_OF_MEAN|1.9||||90.0|-0.28|6.61||||||||6.61|-0.28|
71131152|NCT03139344|141766131|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
71131153|NCT03139344|141766131|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
71131154|NCT03139344|141766132|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
71131155|NCT03139344|141766132|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
71131156|NCT03139344|141766133|SUPERIORITY|||||||0.011|||||||ANOVA|||||||0.011
71131157|NCT03139344|141766133|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
71131158|NCT03139344|141766134|SUPERIORITY|||||||0.148|||||||ANOVA|||||||0.148
71131159|NCT03139344|141766134|SUPERIORITY|||||||0.005|||||||ANOVA|||||||0.005
71131160|NCT03139344|141766135|SUPERIORITY|||||||0.069|||||||ANOVA|||||||0.069
71131161|NCT03139344|141766135|SUPERIORITY|||||||0.003|||||||ANOVA|||||||0.003
71131162|NCT03139344|141766136|SUPERIORITY|||||||0.118|||||||ANOVA|||||||0.118
71131163|NCT03139344|141766136|SUPERIORITY|||||||0.01|||||||ANOVA|||||||0.010
71131164|NCT03139344|141766137|SUPERIORITY|||||||0.059|||||||ANOVA|||||||0.059
71131165|NCT03139344|141766137|SUPERIORITY|||||||0.015|||||||ANOVA|||||||0.015
71131166|NCT03139344|141766138|SUPERIORITY|||||||0.01|||||||ANOVA|||||||0.010
71131167|NCT03139344|141766138|SUPERIORITY|||||||0.001|||||||ANOVA|||||||0.001
71131168|NCT03139344|141766139|SUPERIORITY|||||||0.036|||||||t-test, 2 sided|||||||0.036
71131169|NCT03139344|141766140|SUPERIORITY|||||||0.345|||||||t-test, 2 sided|||||||0.345
71131170|NCT03139344|141766141|SUPERIORITY|||||||0.264|||||||t-test, 2 sided|||||||0.264
71131171|NCT03139344|141766142|SUPERIORITY|||||||0.266|||||||t-test, 2 sided|||||||0.266
71131172|NCT03139344|141766143|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.040
71131173|NCT03139344|141766144|SUPERIORITY|||||||0.109|||||||t-test, 2 sided|||||||0.109
71131174|NCT03139344|141766145|SUPERIORITY|||||||0.895|||||||t-test, 2 sided|||||||0.895
71131175|NCT03139344|141766146|SUPERIORITY|||||||0.573|||||||t-test, 2 sided|paired t-test||||||0.573
71131176|NCT03139344|141766147|SUPERIORITY|||||||0.858|||||||t-test, 2 sided|paired t-test||||||0.858
71131177|NCT00122369|141766159|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||Bonferoni correction was made so that results with p\<0.0167 are considered significant|t-test, 2 sided|||The impact of knowing or not knowing the diagnosis became so overwhelming and group composition with regard of whether and which result had been communicated changed daily in the post-biopsy follow-up, so that the originally planned analysis of the impact of Self-Hynotic Relaxation or Empathic Attention on cortisol measures became underpowered. Therefore we focused on the analysis of the impact of diagnosis.||||0.014
71131178|NCT00122369|141766159|SUPERIORITY_OR_OTHER|||||||0.421||95.0||||Bonferoni correction was made so that results with p\<0.0167 are considered significant.|t-test, 2 sided|||||||0.421
71131179|NCT00122369|141766159|SUPERIORITY_OR_OTHER|||||||0.138||95.0||||Bonferoni correction was made so that results with p\<0.0167 are considered significant.|t-test, 2 sided|||||||0.138
71131180|NCT00122369|141766160|SUPERIORITY_OR_OTHER|||||||0.56|||||||ANOVA|||The null-hypothesis was that there would be no difference among groups.||||0.56
71131181|NCT00122369|141766172|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ordinal regression|||||||<0.001
71131182|NCT00122369|141766172|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||Ordinal regression|||||||0.45
71131183|NCT00122369|141766172|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ordinal regression|||||||<0.001
71131184|NCT00122369|141766172|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Proportional odds model|||||||<0.01
71131185|NCT00122369|141766172|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Proportional odds model|||||||<0.001
71131186|NCT00122369|141766172|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Proportional odds model|||||||<0.01
71131187|NCT00122369|141766185|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ordinal regression|||||||<0.001
71131188|NCT00122369|141766185|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ordinal regression|||||||<0.001
71131189|NCT00122369|141766185|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ordinal regression|||||||<0.001
71131190|NCT00122369|141766185|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||Proportional odds model|||||||0.024
71131191|NCT00122369|141766185|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||Proportional odds model|||||||0.018
71131192|NCT00122369|141766185|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Proportional odds model|||||||0.73
71131193|NCT00999518|141766186|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.4|0.35||||||The 3 parameter E max dose-response model, including baseline as a covariate, was fitted to estimate mean difference (tanezumab minus placebo) and associated 95% confidence interval (CI).||0.35|-0.40|
71131194|NCT00999518|141766186|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|95.0|-0.8|0.68||||||The 3 parameter E max dose-response model, including baseline as a covariate, was fitted to estimate mean difference (tanezumab minus placebo) and associated 95% CI.||0.68|-0.80|
71131195|NCT00999518|141766186|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16|||||TWO_SIDED|95.0|-1.15|0.83||||||The 3 parameter E max dose-response model, including baseline as a covariate, was fitted to estimate mean difference (tanezumab minus placebo) and associated 95% CI.||0.83|-1.15|
71131196|NCT00999518|141766186|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|||||TWO_SIDED|95.0|-0.93|0.47||||||The 3 parameter E max dose-response model, including baseline as a covariate, was fitted to estimate mean difference (tanezumab minus placebo) and associated 95% CI.||0.47|-0.93|
71131197|NCT00999518|141766188|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.66|||||TWO_SIDED|95.0|0.259|1.683||||||Week 8, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||1.683|0.259|
70947157|NCT02808975|141394828|SUPERIORITY||||||=|0.067|||||||Cochran-Mantel-Haenszel|Across all strata, P-value calculated from Cochran-Mantel-Haenszel test adjusted for strata. Stratum containing zero count: 0.1 added to each cell.||||||=0.067
71131198|NCT00999518|141766188|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.975|||||TWO_SIDED|95.0|0.387|2.457||||||Week 8, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.457|0.387|
71131199|NCT00999518|141766188|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.969|||||TWO_SIDED|95.0|0.392|2.398||||||Week 8, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.398|0.392|
71131200|NCT00999518|141766188|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.969|||||TWO_SIDED|95.0|0.392|2.398||||||Week 8, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.398|0.392|
71131201|NCT00999518|141766188|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.629|||||TWO_SIDED|95.0|0.202|1.96||||||Week 8, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||1.960|0.202|
71131202|NCT00999518|141766188|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.179|||||TWO_SIDED|95.0|0.411|3.376||||||Week 8, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||3.376|0.411|
71131203|NCT00999518|141766188|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.222|||||TWO_SIDED|95.0|0.438|3.414||||||Week 8, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||3.414|0.438|
71131204|NCT00999518|141766188|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.778|||||TWO_SIDED|95.0|0.259|2.335||||||Week 8, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.335|0.259|
71131205|NCT00999518|141766188|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.929|||||TWO_SIDED|95.0|0.37|2.327||||||Week 16, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.327|0.370|
71131206|NCT00999518|141766188|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.083|||||TWO_SIDED|95.0|0.427|2.749||||||Week 16, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.749|0.427|
71131207|NCT00999518|141766188|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.759|||||TWO_SIDED|95.0|0.295|1.952||||||Week 16, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||1.952|0.295|
71131208|NCT00999518|141766188|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.759|||||TWO_SIDED|95.0|0.295|1.952||||||Week 16, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||1.952|0.295|
71131209|NCT00999518|141766188|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.875|||||TWO_SIDED|95.0|0.285|2.682||||||Week 16, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.682|0.285|
71131210|NCT00999518|141766188|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.366|||||TWO_SIDED|95.0|0.466|4.006||||||Week 16, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||4.006|0.466|
71131211|NCT00999518|141766188|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.75|||||TWO_SIDED|95.0|0.235|2.394||||||Week 16, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.394|0.235|
70860299|NCT01227564|141206986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.072||||0.1707|TWO_SIDED|95.0|-0.032|0.176||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.176|-0.032|0.1707
70947158|NCT02808975|141394829|SUPERIORITY||||||=|0.003|||||||Cochran-Mantel-Haenszel|Across all strata, P-value calculated from Cochran-Mantel-Haenszel test adjusted for strata. Stratum containing zero count: 0.1 added to each cell.||||||=0.003
70947159|NCT02808975|141394830|SUPERIORITY||||||=|0.313|||||||ANCOVA|Across all strata, P-values are calculated from ANCOVA with stratum, baseline value, and treatment in the model.||||||=0.313
70947160|NCT02808975|141394831|SUPERIORITY||||||=|0.746|||||||Cochran-Mantel-Haenszel|Across all strata, P-value calculated from Cochran-Mantel-Haenszel test adjusted for strata. Stratum containing zero count: 0.1 added to each cell.||||||=0.746
70947161|NCT02166476|141394869|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority margin was a difference of 15%. Noninferiority was concluded if the lower limit of the two-sided 95% confidence interval (CI) for the treatment difference for overall success at EOIVT was \>-15%.|Treatment difference|4.5|||||TWO_SIDED|95.0|0.7|9.1|||||Treatment difference is the estimate of the difference in the overall success rate between the two treatment arms. The difference estimates and the 95% CIs are obtained based on Miettinen and Nurminen method.|Treatment comparison of the m-MITT population||9.1|0.7|
70872060|NCT02155608|141229485|SUPERIORITY|||||||0.0004|||||||Mixed Models Analysis|Time: F=13.03; df = 1/209.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||.0004
70947162|NCT02166476|141394870|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority margin was a difference of 15%. Meropenem-vaborbactam was claimed to be noninferior only if noninferiority was demonstrated for microbial eradication at TOC in the m-MITT Population.|Treatment difference|9.0|||||TWO_SIDED|95.0|-0.9|18.7|||||Treatment difference is the estimate of the difference in the Eradication rate between the two treatment arms. The difference estimates and the 95% CIs are obtained based on Miettinen and Nurminen method.|Treatment comparison of the m-MITT population||18.7|-0.9|
70947163|NCT02166476|141394871|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority margin was a difference of 15%. Meropenem-vaborbactam was claimed to be noninferior only if noninferiority was demonstrated for microbial eradication at TOC in the ME Population.|Treatment Difference|5.9|||||TWO_SIDED|95.0|-4.2|16.0|||||Treatment difference is the estimate of the difference in the overall success rate between the two treatment arms. The difference estimates and the 95% CIs are obtained based on Miettinen and Nurminen method.|Treatment comparison of the ME population||16.0|-4.2|
70947164|NCT01076244|141394884|SUPERIORITY_OR_OTHER||change from baseline|13.43|STANDARD_DEVIATION|16.55|<|0.0001|TWO_SIDED|95.0|8.42|18.43|||t-test, 2 sided|||||18.43|8.42|<0.0001
70947165|NCT01076244|141394886|SUPERIORITY_OR_OTHER||change from baseline|2.17|STANDARD_DEVIATION|3.29|<|0.0001|TWO_SIDED|95.0|1.17|3.16|||t-test, 2 sided|||||3.16|1.17|<0.0001
70947166|NCT02053610|141394946|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||<|0.0001|TWO_SIDED|95.0|0.41|0.58|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.58|0.41|<0.0001
70947167|NCT02053610|141394948|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.33|0.54|||Log Rank, Stratified|Stratified by Binet stage at Baseline.|Stratified by Binet stage at Baseline.|||0.54|0.33|<0.0001
70947168|NCT02053610|141394950|SUPERIORITY_OR_OTHER||Difference in Response Rates|13.22||||0.0001|TWO_SIDED|95.0|6.3|20.1|||Chi-squared|||Includes participants with EOTR: CR, CRi, PR or nPR.||20.1|6.3|0.0001
70947169|NCT02053610|141394951|SUPERIORITY_OR_OTHER||Difference in Response Rates|12.92||||0.0002|TWO_SIDED|95.0|6.1|19.8|||Chi-squared|||Includes participants with best overall response: CR, CRi, PR or nPR.||19.8|6.1|0.0002
70947170|NCT02053610|141394952|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.43|0.61|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.61|0.43|<0.0001
70947171|NCT02053610|141394953|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.76||||0.0245|TWO_SIDED|95.0|0.6|0.97|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.97|0.60|0.0245
70947172|NCT02053610|141394954|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.41|0.61|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.61|0.41|<0.0001
71131212|NCT00999518|141766188|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.063|||||TWO_SIDED|95.0|0.356|3.168||||||Week 16, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||3.168|0.356|
71131213|NCT00999518|141766191|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.263||||0.5731|TWO_SIDED|95.0|0.56|2.848|||Regression, Logistic|||Week 8: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis.||2.848|0.560|0.5731
71131214|NCT00999518|141766191|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.656||||0.2592|TWO_SIDED|95.0|0.689|3.98|||Regression, Logistic|||Week 8: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis.||3.980|0.689|0.2592
70860300|NCT01227564|141206986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.3732|TWO_SIDED|95.0|-0.049|0.129||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.129|-0.049|0.3732
70860301|NCT01227564|141206987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006||||0.7259|TWO_SIDED|95.0|-0.04|0.028||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.028|-0.040|0.7259
70860302|NCT01227564|141206987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016||||0.3517|TWO_SIDED|95.0|-0.018|0.051||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.051|-0.018|0.3517
70860303|NCT01227564|141206987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005||||0.7311|TWO_SIDED|95.0|-0.024|0.035||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.035|-0.024|0.7311
70860304|NCT01227564|141206987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008||||0.6446|TWO_SIDED|95.0|-0.041|0.026||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.026|-0.041|0.6446
70860305|NCT01227564|141206987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.064|TWO_SIDED|95.0|-0.002|0.066||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.066|-0.002|0.0640
70860306|NCT01227564|141206987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012||||0.4057|TWO_SIDED|95.0|-0.017|0.041||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.041|-0.017|0.4057
71131215|NCT00999518|141766191|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.9181||||1.045|TWO_SIDED|95.0|0.452|2.417|||Regression, Logistic|||Week 8: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis.||2.417|0.452|1.045
71131216|NCT00999518|141766191|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.306||||0.5289|TWO_SIDED|95.0|0.569|2.997|||Regression, Logistic|||Week 8: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis.||2.997|0.569|0.5289
71131217|NCT00999518|141766191|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.893||||0.793|TWO_SIDED|95.0|0.385|2.074|||Regression, Logistic|||Week 16: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis. For Week 16, data scores were combined into 3 categories: Improved ('slightly improved', 'moderately improved', 'markedly improved'), No Change ('no change') and Worse ('markedly worse', 'moderately worse', 'slightly worse') for comparison.||2.074|0.385|0.7930
71131218|NCT00999518|141766191|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.167||||0.7386|TWO_SIDED|95.0|0.471|2.892|||Regression, Logistic|||Week 16: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis. For Week 16, data scores were combined into 3 categories: Improved ('slightly improved', 'moderately improved', 'markedly improved'), No Change ('no change') and Worse ('markedly worse', 'moderately worse', 'slightly worse') for comparison.||2.892|0.471|0.7386
71131219|NCT00999518|141766191|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.036||||0.9354|TWO_SIDED|95.0|0.437|2.46|||Regression, Logistic|||Week 16: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis. For Week 16, data scores were combined into 3 categories: Improved ('slightly improved', 'moderately improved', 'markedly improved'), No Change ('no change') and Worse ('markedly worse', 'moderately worse', 'slightly worse') for comparison.||2.460|0.437|0.9354
70860307|NCT01227564|141206987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015||||0.5742|TWO_SIDED|95.0|-0.066|0.037||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.037|-0.066|0.5742
70860308|NCT01227564|141206987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.1336|TWO_SIDED|95.0|-0.013|0.093||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.093|-0.013|0.1336
70947173|NCT02053610|141394956|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.58|||<|0.0001|TWO_SIDED|95.0|0.46|0.73|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.73|0.46|<0.0001
70947174|NCT03568812|141394959|SUPERIORITY||Mean Difference (Net)|111.8||||0.02|TWO_SIDED|95.0|40.9|182.7||The threshold for statistical significance was p = 0.05 The variable was adjusted to duration of ARV regimen and baseline CD4 level|ANCOVA||Treatment difference = Probiotics - Placebo|The statistical analysis of unadjusted CD4 level||182.7|40.9|0.02
70947175|NCT03568812|141394959|SUPERIORITY||Mean Difference (Net)|73.4||||0.03|TWO_SIDED|95.0|5.9|140.8||The threshold for statistical significance was p = 0.05 The variable was adjusted to duration of ARV regimen and baseline CD4 level|ANCOVA||Treatment difference = Probiotics - Placebo|The statistical analysis of adjusted CD4 level||140.8|5.9|0.03
70947176|NCT03568812|141394960|SUPERIORITY||Mean Difference (Net)|0.3||||0.55|TWO_SIDED|95.0|-0.5|1.0||The threshold for statistical significance was p = 0.05 The variable was adjusted to duration of ARV regimen and baseline CD4 level|ANCOVA||There is no difference between probiotics - placebo|The statistical analysis of unadjusted Th17 change after intervention||1.0|-0.5|0.55
70947177|NCT03568812|141394960|SUPERIORITY||Mean Difference (Net)|0.1||||0.79|TWO_SIDED|95.0|-0.7|0.9||The threshold for statistical significance was p = 0.05 The variable was adjusted to duration of ARV regimen and baseline CD4 level|ANCOVA||There is no difference between probiotics - placebo|The statistical analysis of adjusted Th17 change after intervention||0.9|-0.7|0.79
70947178|NCT03568812|141394962|SUPERIORITY||Mean Difference (Net)|-12.7||||0.03|TWO_SIDED|95.0|-23.9|-1.5||The threshold for statistical significance was p = 0.05 The variable was adjusted to duration of ARV regimen and baseline CD4 level|ANCOVA||Treatment difference = Probiotics - Placebo|The statistical analysis of unadjusted Fecal Calprotectin Level change after intervention||-1.5|-23.9|0.03
70947179|NCT03568812|141394962|SUPERIORITY||Mean Difference (Net)|-15.6||||0.01|TWO_SIDED|95.0|-27.6|-3.6||The threshold for statistical significance was p = 0.05 The variable was adjusted to duration of ARV regimen and baseline CD4 level|ANCOVA||Treatment difference = Probiotics - Placebo|The statistical analysis of adjusted Fecal Calprotectin Level change after intervention||-3.6|-27.6|0.01
70947180|NCT03568812|141394964|SUPERIORITY|||||||0.551||||||The threshold for statistical significance was p = 0.05|Chi-squared|||The statistical analysis of food frequency change after intervention (12 weeks)||||0.551
70947181|NCT01657799|141394993|SUPERIORITY|||||||0.933|||||||Log Rank|Log-rank test stratified by graded prognostic assessment (GPA) score (≤ 2.5 or \> 2.5) at screening. Nominal P-values were reported.||The primary analysis used a Hochberg testing procedure to preserve the familywise error rate for multiple comparisons, where the larger P-value for the comparisons of veliparib 50 mg BID + WBRT with placebo BID + WBRT and veliparib 200 mg BID + WBRT with placebo BID + WBRT were compared to an α = 0.05. If statistically significant (P ≤ 0.05), both comparisons were considered significant. If the larger P-value was not statistically significant, the smaller P-value was compared to an α = 0.025.||||0.933
70947182|NCT01657799|141394993|SUPERIORITY|||||||0.909|||||||Log Rank|Log-rank test stratified by GPA score (≤ 2.5 or \> 2.5) at screening. Nominal P-values were reported.||The primary analysis used a Hochberg testing procedure to preserve the familywise error rate for multiple comparisons, where the larger P-value for the comparisons of veliparib 50 mg BID + WBRT with placebo BID + WBRT and veliparib 200 mg BID + WBRT with placebo BID + WBRT were compared to an α = 0.05. If statistically significant (P ≤ 0.05), both comparisons were considered significant. If the larger P-value was not statistically significant, the smaller P-value was compared to an α = 0.025.||||0.909
70947183|NCT01657799|141394993|SUPERIORITY||Hazard Ratio (HR)|0.985||||0.927|TWO_SIDED|95.0|0.716|1.355|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or \> 2.5) at screening. Nominal P-values were reported.||||1.355|0.716|0.927
70947184|NCT01657799|141394993|SUPERIORITY||Hazard Ratio (HR)|0.981||||0.906|TWO_SIDED|95.0|0.71|1.354|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or \> 2.5) at screening. Nominal P-values were reported.||||1.354|0.710|0.906
70947185|NCT01657799|141394994|SUPERIORITY|||||||0.535|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||||0.535
70947186|NCT01657799|141394994|SUPERIORITY|||||||0.898|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||||0.898
70947187|NCT01657799|141394995|SUPERIORITY|||||||0.314|||||||Log Rank|Log-rank test stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||||0.314
70947188|NCT01657799|141394995|SUPERIORITY|||||||0.536|||||||Log Rank|Log-rank test stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||||0.536
70947189|NCT01657799|141394995|SUPERIORITY||Hazard Ratio (HR)|1.301||||0.313|TWO_SIDED|95.0|0.78|2.168|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||2.168|0.780|0.313
70947190|NCT01657799|141394995|SUPERIORITY||Hazard Ratio (HR)|1.181||||0.534|TWO_SIDED|95.0|0.698|1.999|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||1.999|0.698|0.534
70947191|NCT01657799|141394996|SUPERIORITY|||||||0.864|||||||Log Rank|Log-rank test stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||||0.864
70947192|NCT01657799|141394996|SUPERIORITY|||||||0.301|||||||Log Rank|Log-rank test stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||||0.301
70947193|NCT01657799|141394996|SUPERIORITY||Hazard Ratio (HR)|1.047||||0.86|TWO_SIDED|95.0|0.626|1.754|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||1.754|0.626|0.860
70947194|NCT01657799|141394996|SUPERIORITY||Hazard Ratio (HR)|1.295||||0.289|TWO_SIDED|95.0|0.803|2.086|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||2.086|0.803|0.289
70947195|NCT01772563|141395013|OTHER||Geometric mean ratio (GMR) [%]|93.63|||||TWO_SIDED|90.0|82.07|106.81|||||GMR (test/reference) i.e. (Volasertib+Itraconazole/ Volasertib). Intra- individual coefficient of variation (gCV%)=25.1.|"Statistical analysis of Volasertib:~AUC0-tz was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR)."||106.81|82.07|
70947196|NCT01772563|141395013|OTHER||Geometric mean ratio (GMR) [%]|75.77|||||TWO_SIDED|90.0|67.83|84.632|||||GMR (test/reference) i.e. (Volasertib+Itraconazole/ Volasertib). Intra- individual coefficient of variation (gCV %)=21.0.|"Statistical analysis of CD 10899:~AUC0-tz was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR)."||84.632|67.830|
70947197|NCT01772563|141395014|OTHER||Geometric mean ratio (GMR) [%]|79.4|||||TWO_SIDED|90.0|64.896|97.137|||||GMR (test/reference) i.e. (Volasertib+Itraconazole/ Volasertib). Intra- individual coefficient of variation (gCV %)=39.3.|"Statistical analysis of volasertib:~Cmax was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR)."||97.137|64.896|
70947198|NCT01772563|141395014|OTHER||Geometric mean ratio (GMR) [%]|63.48|||||TWO_SIDED|90.0|55.372|72.775|||||GMR (test/reference) i.e. (Volasertib+Itraconazole/ Volasertib). Intra- individual coefficient of variation (gCV%)=26.1.|"Statistical analysis of CD 10899:~Cmax was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR)."||72.775|55.372|
70947199|NCT01772563|141395015|OTHER||Geometric mean ratio (GMR) [%]|97.85|||||TWO_SIDED|90.0|87.09|109.94|||||GMR (test/reference) i.e. (Volasertib+Itraconazole/ Volasertib). Intra- individual coefficient of variation (gCV %)=22.7.|"Statistical analysis of volasertib:~AUC0-∞ was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR)."||109.94|87.09|
70947200|NCT01772563|141395015|OTHER||Geometric mean ratio (GMR) [%]|77.42|||||TWO_SIDED|90.0|69.001|86.871|||||GMR (test/reference) i.e. (Volasertib+Itraconazole/ Volasertib). Intra- individual coefficient of variation (gCV %)=22.5.|"Statistical analysis of CD 10899:~AUC0-∞ was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR)."||86.871|69.001|
70947201|NCT01192776|141395017|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.23|||||TWO_SIDED|95.0|0.76|1.98||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.98|0.76|
70947202|NCT01192776|141395017|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.21|||||TWO_SIDED|95.0|0.78|1.87||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.87|0.78|
70947203|NCT01192776|141395017|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.85|||||TWO_SIDED|95.0|0.53|1.35||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.35|0.53|
70947204|NCT01192776|141395018|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|2.16|||||TWO_SIDED|95.0|0.55|8.49||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||8.49|0.55|
70947205|NCT01192776|141395018|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|2.52|||||TWO_SIDED|95.0|1.06|5.95||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||5.95|1.06|
70947206|NCT01192776|141395018|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.85|||||TWO_SIDED|95.0|0.79|4.31||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||4.31|0.79|
70947207|NCT01192776|141395023|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.23|||||TWO_SIDED|95.0|0.64|2.38||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||2.38|0.64|
70947208|NCT01192776|141395023|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.36|1.9||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.90|0.36|
70947209|NCT01192776|141395023|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.64|||||TWO_SIDED|95.0|0.26|1.57||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.57|0.26|
70947210|NCT01192776|141395025|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.33|||||TWO_SIDED|95.0|0.63|2.77||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||2.77|0.63|
71131220|NCT00999518|141766191|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.805||||0.6207|TWO_SIDED|95.0|0.341|1.899|||Regression, Logistic|||Week 16: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis. For Week 16, data scores were combined into 3 categories: Improved ('slightly improved', 'moderately improved', 'markedly improved'), No Change ('no change') and Worse ('markedly worse', 'moderately worse', 'slightly worse') for comparison.||1.899|0.341|0.6207
71131221|NCT00250276|141766233|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The first primary objective was reached as the 95% Confidence Interval (CI) of the GMC ratio between lots was within \[0.5;2\] for the anti-HPV-16 antibodies.|GMC ratio for anti-HPV-16 antibody|1.04|||||TWO_SIDED|95.0|0.81|1.34|||ANOVA|The ANOVA model on the logarithm (log)10 transformation of the concentrations. The ANOVA model included the vaccine group as fixed effect.||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.||1.34|0.81|
71131222|NCT00250276|141766233|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within \[0.5;2\] for the anti-HPV-18 antibodies.|GMC ratio for anti-HPV-18 antibody|1.19|||||TWO_SIDED|95.0|0.95|1.49|||ANOVA|The ANOVA model on the log10 transformation of theconcentrations. The ANOVA model included the vaccine group as fixed effect.||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.||1.49|0.95|
71131223|NCT00250276|141766233|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within \[0.5;2\] for the anti-HPV-16 antibodies.|GMC ratio for anti-HPV-16 antibody|1.26|||||TWO_SIDED|95.0|0.98|1.63|||ANOVA|The ANOVA model on the log10 transformation of the concnetration. The ANOVA model included the vaccine group as fixed effect.||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.||1.63|0.98|
71131224|NCT00250276|141766233|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within \[0.5;2\] for the anti-HPV-18 antibodies.|GMC ratio for anti-HPV-18 antibody|1.48|||||TWO_SIDED|95.0|1.18|1.85|||ANOVA|The ANOVA model on the log10 transformation of the concnetration. The ANOVA model included the vaccine group as fixed effect.||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.||1.85|1.18|
71131225|NCT00250276|141766233|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within \[0.5;2\] for the anti-HPV-16 antibodies.|GMT ratio for anti-HPV-16 antibody|1.21|||||TWO_SIDED|95.0|0.94|1.55|||ANOVA|The ANOVA model on the log10 transformation of the concentration. The ANOVA model included the vaccine group as fixed effect.||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.||1.55|0.94|
71131226|NCT00250276|141766233|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within \[0.5;2\] for the anti-HPV-18 antibodies.|GMC ratio for anti-HPV-18 antibody|1.24|||||TWO_SIDED|95.0|1.0|1.55|||ANOVA|The ANOVA model on the log10 transformation of the concentration. The ANOVA model included the vaccine group as fixed effect.||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.||1.55|1.00|
71131227|NCT00250276|141766233|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The second primary objective was reached as the upper limit of the 95% CI of the difference in seroconversion rates for anti-HPV-16 antibodies was below 5%.|Difference in seroconversion rate|0.0|||||TWO_SIDED|95.0|-3.63|1.02|||Proc StatXact 5.0|||To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, one month after the third dose (Month 7).||1.02|-3.63|
71131228|NCT00250276|141766233|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The second primary objective was reached as the upper limit of the 95% CI of the difference in seroconversion rates for anti-HPV-18 antibodies was below 5%.|Difference in seroconversion rate|0.0|||||TWO_SIDED|95.0|-3.18|0.94|||Proc StatXact 5.0|||To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, on month after the third dose (Month 7).||0.94|-3.18|
70860309|NCT01227564|141206987|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.013||||0.5734|TWO_SIDED|95.0|-0.033|0.058||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.058|-0.033|0.5734
70860310|NCT01227564|141206987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.016||||0.7067|TWO_SIDED|95.0|-0.104|0.071||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.071|-0.104|0.7067
70860311|NCT01227564|141206987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042||||0.36|TWO_SIDED|95.0|-0.049|0.132||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.132|-0.049|0.3600
70860312|NCT01227564|141206987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.013||||0.7454|TWO_SIDED|95.0|-0.065|0.09||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.090|-0.065|0.7454
70860313|NCT01227564|141206987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006||||0.9037|TWO_SIDED|95.0|-0.113|0.1||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.100|-0.113|0.9037
70947211|NCT01192776|141395025|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.42|||||TWO_SIDED|95.0|0.09|2.04||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||2.04|0.09|
71131229|NCT00250276|141766233|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The second primary objective was reached as the upper limit of the 95% CI of the GMC rates for anti-HPV-16 was below 2%.|GMC ratio for anti-HPV-16 antibody|0.87|||||TWO_SIDED|95.0|0.7|1.08|||ANOVA|The ANOVA model on the log10 transformation of the concentration, included the vaccine groups as fixed effect (pooled 600L lot versus 80L lot).||To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, on month after the third dose (Month 7).||1.08|0.70|
71131230|NCT00250276|141766233|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The second primary objective was reached as the upper limit of the 95% CI of the GMC rates anti-HPV-18 antibodies was below 2%.|GMC ratio for anti-HPV-18 antibody|0.8|||||TWO_SIDED|95.0|0.66|0.97|||ANOVA|The ANOVA model on the log10 transformation of the concentration, included the vaccine groups as fixed effect (pooled 600L lot versus 80L lot).||To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, on month after the third dose (Month 7).||0.97|0.66|
71131231|NCT03334812|141766285|SUPERIORITY||Mean Difference (Net)|0.18||||0.1219|TWO_SIDED|95.0|-0.15|0.51|||Mixed Effect Model Repeat Measurement|||SCD/HNWB||0.51|-0.15|0.1219
71131232|NCT03334812|141766285|SUPERIORITY||Mean Difference (Net)|-0.01||||0.5438|TWO_SIDED|95.0|-0.28|0.25|||Mixed Effect Model Repeat Measurement|||DTBT/HWB||0.25|-0.28|0.5438
71131233|NCT03334812|141766286|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.3067|TWO_SIDED|95.0|-0.19|0.31|||Mixed Effect Model Repeat Measurement|||||0.31|-0.19|0.3067
71131234|NCT03334812|141766288|SUPERIORITY||Mean Difference (Net)|26.23||||0.0404|TWO_SIDED|95.0|-3.86|56.32|||Mixed Effect Model Repeat Measurement|||Week 4||56.32|-3.86|0.0404
71131235|NCT03334812|141766288|SUPERIORITY||Mean Difference (Net)|27.82||||0.1381|TWO_SIDED|95.0|-26.5|82.1|||Mixed Effect Model Repeat Measurement|||Week 12||82.10|-26.5|0.1381
71131236|NCT03334812|141766288|SUPERIORITY||Mean Difference (Net)|23.8||||0.1168|TWO_SIDED|96.0|-19.3|66.89|||Mixed Models Analysis|||Week 28 (EOS)||66.89|-19.3|0.1168
71131237|NCT03334812|141766289|SUPERIORITY||Mean Difference (Net)|-0.01||||0.5175|TWO_SIDED|95.0|-0.26|0.25|||Mixed Effect Model Repeat Measurement|||SCD/HNWB - Week 12||0.25|-0.26|0.5175
71131238|NCT03334812|141766289|SUPERIORITY||Mean Difference (Net)|0.19||||0.1476|TWO_SIDED|95.0|-0.22|0.6|||Mixed Effect Model Repeat Measurement|||SCD/HNWB - Week 28||0.60|-0.22|0.1476
71131239|NCT01865448|141766301|SUPERIORITY_OR_OTHER|||||||0.278|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2780
71131240|NCT01865448|141766301|SUPERIORITY_OR_OTHER|||||||0.8689|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.8689
71131241|NCT01865448|141766301|SUPERIORITY_OR_OTHER|||||||0.4533|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.4533
71131242|NCT01865448|141766302|SUPERIORITY_OR_OTHER|||||||0.71833|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.71833
70860314|NCT01227564|141206987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.2082|TWO_SIDED|95.0|-0.04|0.181||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.181|-0.040|0.2082
70947212|NCT01192776|141395025|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.78|||||TWO_SIDED|95.0|0.2|2.99||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||2.99|0.20|
71131243|NCT01865448|141766302|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
71131244|NCT01865448|141766302|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Within-group comparisons between the baseline and 6 month data||||<0.001
71131245|NCT01865448|141766303|SUPERIORITY_OR_OTHER|||||||0.519|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.51900
71131246|NCT01865448|141766303|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
71131247|NCT01865448|141766303|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
71131248|NCT01865448|141766304|SUPERIORITY_OR_OTHER|||||||0.24567|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.24567
70947213|NCT01192776|141395026|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.65|||||TWO_SIDED|95.0|0.14|3.01||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||3.01|0.14|
70947214|NCT01192776|141395026|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.31|||||TWO_SIDED|95.0|0.44|3.91||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||3.91|0.44|
70947215|NCT01192776|141395026|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.28|||||TWO_SIDED|95.0|0.03|2.89||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||2.89|0.03|
70947216|NCT01192776|141395027|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.87|||||TWO_SIDED|95.0|0.37|2.07||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||2.07|0.37|
70947217|NCT01192776|141395027|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.64|||||TWO_SIDED|95.0|0.3|1.35||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.35|0.30|
70947218|NCT01192776|141395027|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.47|||||TWO_SIDED|95.0|0.13|1.64||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.64|0.13|
70947219|NCT00736125|141395032|EQUIVALENCE|nonparametric data were analyzed using Mann Whitney U Tests|||||>|0.05|||||||t-test, 2 sided|||||||>0.05
70947220|NCT00736125|141395033|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
70947221|NCT03732820|141395051|SUPERIORITY||Hazard Ratio (HR)|0.66|||<|0.0001|TWO_SIDED|95.0|0.54|0.81||A multiple testing procedure is employed across primary (rPFS) and key secondary endpoints (OS) to strongly control overall type 1 error at 2.5% one-sided.|Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||0.81|0.54|<0.0001
70947222|NCT03732820|141395052|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0544|TWO_SIDED|95.0|0.67|1.0||A multiple testing procedure is employed across primary (rPFS) and key secondary endpoints (OS) to strongly control overall type 1 error at 2.5% one-sided. Alpha spend for OS will not exceed 0.02135.|Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||1.00|0.67|0.0544
71131249|NCT01865448|141766304|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
71131250|NCT01865448|141766304|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
71131251|NCT01865448|141766305|SUPERIORITY_OR_OTHER|||||||0.9573|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.9573
71131252|NCT01865448|141766305|SUPERIORITY_OR_OTHER|||||||0.5257|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.5257
71131253|NCT01865448|141766305|SUPERIORITY_OR_OTHER|||||||0.0657|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0657
71131254|NCT01865448|141766306|SUPERIORITY_OR_OTHER|||||||0.7474|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.7474
71131255|NCT01865448|141766306|SUPERIORITY_OR_OTHER|||||||0.3745|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.3745
71131256|NCT01865448|141766306|SUPERIORITY_OR_OTHER|||||||0.0476|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0476
71131257|NCT01865448|141766307|SUPERIORITY_OR_OTHER|||||||0.27444|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.27444
71131258|NCT01865448|141766307|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
71131259|NCT01865448|141766307|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
71131260|NCT01865448|141766308|SUPERIORITY_OR_OTHER|||||||0.28489|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.28489
71131261|NCT01865448|141766308|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
71131262|NCT01865448|141766308|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||||||<0.001
70872061|NCT02155608|141229485|SUPERIORITY|||||||0.37|||||||Mixed Models Analysis|Group \* time: F = .83; df = 1/209.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||.37
71131263|NCT01865448|141766309|SUPERIORITY_OR_OTHER|||||||0.04491|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.04491
71131264|NCT01865448|141766309|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
71131265|NCT01865448|141766309|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
71131266|NCT01865448|141766310|SUPERIORITY_OR_OTHER|||||||0.24396|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.24396
71131267|NCT01865448|141766310|SUPERIORITY_OR_OTHER|||||||0.00162|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.00162
71131268|NCT01865448|141766310|SUPERIORITY_OR_OTHER|||||||0.00162|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.00162
71131269|NCT01865448|141766311|SUPERIORITY_OR_OTHER|||||||0.82322|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.82322
71131270|NCT01865448|141766311|SUPERIORITY_OR_OTHER|||||||0.25908|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.25908
71131271|NCT01865448|141766311|SUPERIORITY_OR_OTHER|||||||0.25908|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.25908
71131272|NCT01865448|141766312|SUPERIORITY_OR_OTHER|||||||0.76435|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.76435
71131273|NCT01865448|141766312|SUPERIORITY_OR_OTHER|||||||0.18876|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.18876
71131274|NCT01865448|141766312|SUPERIORITY_OR_OTHER|||||||0.18876|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.18876
71131275|NCT01865448|141766313|SUPERIORITY_OR_OTHER|||||||0.40485|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.40485
71131276|NCT01865448|141766313|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
71131277|NCT01865448|141766313|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
71131278|NCT01865448|141766314|SUPERIORITY_OR_OTHER|||||||0.13911|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.13911
71131279|NCT01865448|141766314|SUPERIORITY_OR_OTHER|||||||0.05726|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.05726
71131280|NCT01865448|141766314|SUPERIORITY_OR_OTHER|||||||0.05726|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.05726
71131281|NCT01865448|141766315|SUPERIORITY_OR_OTHER|||||||0.60214|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.60214
71131282|NCT01865448|141766315|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
71131283|NCT01865448|141766315|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
71131284|NCT01865448|141766316|SUPERIORITY_OR_OTHER|||||||0.66053|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.66053
71131285|NCT01865448|141766316|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
71131286|NCT01865448|141766316|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.05
71131287|NCT01865448|141766317|SUPERIORITY_OR_OTHER|||||||0.28743|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.28743
71131288|NCT01865448|141766317|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
71131289|NCT01865448|141766317|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
71131290|NCT01865448|141766318|SUPERIORITY_OR_OTHER|||||||0.58561|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.58561
71131291|NCT01865448|141766318|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
71131292|NCT01865448|141766318|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||||||<0.001
71131293|NCT01865448|141766319|SUPERIORITY_OR_OTHER|||||||0.1953|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.1953
71131294|NCT01865448|141766319|SUPERIORITY_OR_OTHER|||||||0.0351|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0351
71131295|NCT01865448|141766319|SUPERIORITY_OR_OTHER|||||||0.0795|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0795
71131296|NCT01865448|141766320|SUPERIORITY_OR_OTHER|||||||0.6664|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.6664
71131297|NCT01865448|141766320|SUPERIORITY_OR_OTHER|||||||0.431|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.4310
71131298|NCT01865448|141766320|SUPERIORITY_OR_OTHER|||||||0.0049|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0049
71131299|NCT01865448|141766321|SUPERIORITY_OR_OTHER|||||||0.247|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2470
71131300|NCT01865448|141766321|SUPERIORITY_OR_OTHER|||||||0.2755|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.2755
71131301|NCT01865448|141766321|SUPERIORITY_OR_OTHER|||||||0.8226|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.8226
71131302|NCT01865448|141766322|SUPERIORITY_OR_OTHER|||||||0.6779|||||||ANCOVA|||Between-Group Comparison||||0.6779
71131303|NCT01865448|141766322|SUPERIORITY_OR_OTHER|||||||0.3761|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.3761
71131304|NCT01865448|141766322|SUPERIORITY_OR_OTHER|||||||0.0281|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0281
71131305|NCT01865448|141766323|SUPERIORITY_OR_OTHER|||||||0.8591|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.8591
71131306|NCT01865448|141766323|SUPERIORITY_OR_OTHER|||||||0.0404|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0404
71131307|NCT01865448|141766323|SUPERIORITY_OR_OTHER|||||||0.0474|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0474
71131308|NCT01865448|141766324|SUPERIORITY_OR_OTHER|||||||0.3187|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.3187
71131309|NCT01865448|141766324|SUPERIORITY_OR_OTHER|||||||0.0482|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0482
71131310|NCT01865448|141766324|SUPERIORITY_OR_OTHER|||||||0.0394|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0394
71131311|NCT01865448|141766325|SUPERIORITY_OR_OTHER|||||||0.2813|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2813
71131312|NCT01865448|141766325|SUPERIORITY_OR_OTHER|||||||0.4421|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.4421
71131313|NCT01865448|141766325|SUPERIORITY_OR_OTHER|||||||0.3198|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.3198
71131314|NCT01865448|141766326|SUPERIORITY_OR_OTHER|||||||0.2792|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2792
71131315|NCT01865448|141766326|SUPERIORITY_OR_OTHER|||||||0.1034|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.1034
71131316|NCT01865448|141766326|SUPERIORITY_OR_OTHER|||||||0.9898|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.9898
71131317|NCT01865448|141766327|SUPERIORITY_OR_OTHER|||||||0.7047|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.7047
71131318|NCT01865448|141766327|SUPERIORITY_OR_OTHER|||||||0.4749|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.4749
71131319|NCT01865448|141766327|SUPERIORITY_OR_OTHER|||||||0.6014|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.6014
71131320|NCT01865448|141766328|SUPERIORITY_OR_OTHER|||||||0.5932|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.5932
71131321|NCT01865448|141766328|SUPERIORITY_OR_OTHER|||||||0.714|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.7140
71131322|NCT01865448|141766328|SUPERIORITY_OR_OTHER|||||||0.5827|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.5827
71131323|NCT01865448|141766329|SUPERIORITY_OR_OTHER|||||||0.2894|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2894
71131324|NCT01865448|141766329|SUPERIORITY_OR_OTHER|||||||0.2128|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.2128
71131325|NCT01865448|141766329|SUPERIORITY_OR_OTHER|||||||0.0823|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0823
71131326|NCT01865448|141766330|SUPERIORITY_OR_OTHER|||||||0.345|||||||ANCOVA|||Between-Group Comparison||||0.3450
71131327|NCT01865448|141766330|SUPERIORITY_OR_OTHER|||||||0.1365|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.1365
71131328|NCT01865448|141766330|SUPERIORITY_OR_OTHER|||||||0.0073|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0073
71131329|NCT01865448|141766331|SUPERIORITY_OR_OTHER|||||||0.2333|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2333
71131330|NCT01865448|141766331|SUPERIORITY_OR_OTHER|||||||0.4292|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.4292
71131331|NCT01865448|141766331|SUPERIORITY_OR_OTHER|||||||0.3356|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.3356
71131332|NCT01865448|141766332|SUPERIORITY_OR_OTHER|||||||0.683|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.6830
71131333|NCT01865448|141766332|SUPERIORITY_OR_OTHER|||||||0.8625|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.8625
71131334|NCT01865448|141766332|SUPERIORITY_OR_OTHER|||||||0.0068|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0068
71131335|NCT01865448|141766333|SUPERIORITY_OR_OTHER|||||||0.3694|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.3694
71131336|NCT01865448|141766333|SUPERIORITY_OR_OTHER|||||||0.0291|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0291
71131337|NCT01865448|141766333|SUPERIORITY_OR_OTHER|||||||0.0402|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0402
71131338|NCT01865448|141766334|SUPERIORITY_OR_OTHER|||||||0.1226|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.1226
71131339|NCT01865448|141766334|SUPERIORITY_OR_OTHER|||||||0.0472|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0472
71131340|NCT01865448|141766334|SUPERIORITY_OR_OTHER|||||||0.0197|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0197
71131341|NCT01865448|141766335|SUPERIORITY_OR_OTHER|||||||0.8969|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.8969
71131342|NCT01865448|141766335|SUPERIORITY_OR_OTHER|||||||0.7218|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.7218
71131343|NCT01865448|141766335|SUPERIORITY_OR_OTHER|||||||0.4536|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.4536
71131344|NCT01865448|141766336|SUPERIORITY_OR_OTHER|||||||0.8765|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.8765
71131345|NCT01865448|141766336|SUPERIORITY_OR_OTHER|||||||0.5114|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.5114
71131346|NCT01865448|141766336|SUPERIORITY_OR_OTHER|||||||0.0237|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0237
71131347|NCT01865448|141766337|SUPERIORITY_OR_OTHER|||||||0.2914|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2914
71131348|NCT01865448|141766337|SUPERIORITY_OR_OTHER|||||||0.5594|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.5594
71131349|NCT01865448|141766337|SUPERIORITY_OR_OTHER|||||||0.2532|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.2532
71131350|NCT01865448|141766338|SUPERIORITY_OR_OTHER|||||||0.0528|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.0528
71131351|NCT01865448|141766338|SUPERIORITY_OR_OTHER|||||||0.192|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.1920
71131352|NCT01865448|141766338|SUPERIORITY_OR_OTHER|||||||0.0011|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0011
71131353|NCT01865448|141766339|SUPERIORITY_OR_OTHER|||||||0.2999|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2999
71131354|NCT01865448|141766339|SUPERIORITY_OR_OTHER|||||||0.5184|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.5184
71131355|NCT01865448|141766339|SUPERIORITY_OR_OTHER|||||||0.0564|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0564
71131356|NCT01865448|141766340|SUPERIORITY_OR_OTHER|||||||0.0783|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.0783
71131357|NCT01865448|141766340|SUPERIORITY_OR_OTHER|||||||0.1263|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.1263
71131358|NCT01865448|141766340|SUPERIORITY_OR_OTHER|||||||0.6484|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.6484
71131359|NCT01865448|141766341|SUPERIORITY_OR_OTHER|||||||0.6896|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.6896
71131360|NCT01865448|141766341|SUPERIORITY_OR_OTHER|||||||0.098|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0980
71131361|NCT01865448|141766341|SUPERIORITY_OR_OTHER|||||||0.3526|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.3526
71131362|NCT01865448|141766342|SUPERIORITY_OR_OTHER|||||||0.9662|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.9662
71131363|NCT01865448|141766342|SUPERIORITY_OR_OTHER|||||||0.145|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.1450
71131364|NCT01865448|141766342|SUPERIORITY_OR_OTHER|||||||0.3811|TWO_SIDED||||||Paired t-test|||||||0.3811
71131365|NCT01865448|141766343|SUPERIORITY_OR_OTHER|||||||0.2643|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2643
71131366|NCT01865448|141766343|SUPERIORITY_OR_OTHER|||||||0.0761|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0761
71131367|NCT01865448|141766343|SUPERIORITY_OR_OTHER|||||||0.1342|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.1342
71131368|NCT01865448|141766344|SUPERIORITY_OR_OTHER|||||||0.141|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.1410
71131369|NCT01865448|141766344|SUPERIORITY_OR_OTHER|||||||0.3774|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.3774
71131370|NCT01865448|141766344|SUPERIORITY_OR_OTHER|||||||0.1811|TWO_SIDED||||||Paired t-test|||||||0.1811
71131371|NCT01865448|141766345|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||<0.0001
71131372|NCT01865448|141766345|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.0001
71131373|NCT01865448|141766345|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.0001
71131374|NCT01865448|141766346|SUPERIORITY_OR_OTHER|||||||0.5893|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.5893
71131375|NCT01865448|141766346|SUPERIORITY_OR_OTHER|||||||0.0431|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0431
71131376|NCT01865448|141766346|SUPERIORITY_OR_OTHER|||||||0.0066|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0066
71131377|NCT01865448|141766347|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||<0.0001
71131378|NCT01865448|141766347|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.0001
71131379|NCT01865448|141766347|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.0001
71131380|NCT01865448|141766348|SUPERIORITY_OR_OTHER|||||||0.985|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.9850
71131381|NCT01865448|141766348|SUPERIORITY_OR_OTHER|||||||0.0049|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0049
71131382|NCT01865448|141766348|SUPERIORITY_OR_OTHER|||||||0.0062|TWO_SIDED||||||Paired t-test|||||||0.0062
71131383|NCT01865448|141766349|SUPERIORITY_OR_OTHER|||||||0.1946|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.1946
71131384|NCT01865448|141766349|SUPERIORITY_OR_OTHER|||||||0.2337|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.2337
71131385|NCT01865448|141766349|SUPERIORITY_OR_OTHER|||||||0.9188|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.9188
71131386|NCT01865448|141766350|SUPERIORITY_OR_OTHER|||||||0.7964|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.7964
71131387|NCT01865448|141766350|SUPERIORITY_OR_OTHER|||||||0.768|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.7680
71131388|NCT01865448|141766350|SUPERIORITY_OR_OTHER|||||||0.5669|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.5669
71131389|NCT01865448|141766351|SUPERIORITY_OR_OTHER|||||||0.032|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.0320
71131390|NCT01865448|141766351|SUPERIORITY_OR_OTHER|||||||0.022|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0220
71131391|NCT01865448|141766351|SUPERIORITY_OR_OTHER|||||||0.4563|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.4563
71131392|NCT01865448|141766352|SUPERIORITY_OR_OTHER|||||||0.72828|TWO_SIDED||||||Fisher Exact|||Between-Group Comparison||||0.72828
71131393|NCT02255461|141766376|OTHER|Ordinal logistic regression model was built for outcome neutropenia (0/1/2). Explanatory variable AUC was transformed by dividing by 100.|Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.97|1.15||||||||1.15|0.97|
71131394|NCT02255461|141766377|OTHER|Ordinal logistic regression model was built for outcome lymphopenia (0/1/2). Explanatory variable AUC was transformed by dividing by 100.|Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.97|1.15||||||||1.15|0.97|
71131395|NCT02255461|141766378|OTHER|Ordinal logistic regression model was built for outcome leukopenia (0/1/2). Explanatory variable AUC was transformed by dividing by 100.|Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|1.01|1.2||||||||1.20|1.01|
71131396|NCT06292130|141766391|OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
71131397|NCT06292130|141766392|OTHER|||||||0.006|||||||t-test, 2 sided|||||||0.006
71131398|NCT03350815|141766393|OTHER|Statistical hypothesis tests were not performed for this study|Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.28|2.25||No P value as no hypothesis was tested|Regression, Logistic|||Statistical analysis (logistic regression) of ASDAS inactive disease response by visit - in Treatment Period 2 (nonresponder imputation)||2.25|0.28|
71131399|NCT03350815|141766394|OTHER|Statistical hypothesis tests were not performed for this study|Odds Ratio (OR)|2.08|||||TWO_SIDED|95.0|0.5|8.66||No P value as no hypothesis was tested|Regression, Logistic|||Statistical analysis (logistic regression) of reduction in ASDAS \>= 1.1 response by visit - in Treatment Period 2 (nonresponder imputation)||8.66|0.50|
71131400|NCT03350815|141766395|OTHER|Statistical hypothesis tests were not performed for this study|Least Square Mean of Treatment Differenc|0.23|STANDARD_ERROR_OF_MEAN|0.263|||TWO_SIDED|95.0|-0.29|0.75||Least squares means (LSMs) of the treatment groups, LSM treatment difference and 95% confidence interval for treatment difference are from mixed-effects model repeated measures (MMRM) with treatment, visit and TNF-alpha inhibitor status as factors|Mixed Models Analysis|||Statistical analysis of total BASDAI change from Week 16 using MMRM - in Treatment Period 2 (FAS)||0.75|-0.29|
71131401|NCT03350815|141766396|OTHER|Statistical hypothesis tests were not performed for this study|Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.5|3.24||Odds ratio and 95% confidence interval for odds ratio are from a logistic regression model with treatment (2 treatment groups), TNF-alpha inhibitor status (naive, inadequate responder) and Week 16 body weight (kg) as explanatory variables.|Regression, Logistic|||Statistical analysis (logistic regression) of BASDAI50 response by visit - in Treatment Period 2 (nonresponder imputation) (FAS)||3.24|0.50|
71131402|NCT03350815|141766397|OTHER|Statistical hypothesis tests were not performed for this study|Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.43|1.73||Odds ratio and 95% confidence interval for odds ratio are from a logistic regression model with treatment (2 treatment groups), TNF-alpha inhibitor status (naive, inadequate responder) and Week 16 body weight (kg) as explanatory variables|Regression, Logistic|||Statistical analysis (logistic regression) of BASDAI20 response by visit - in Treatment Period 2 (nonresponder imputation) (FAS)||1.73|0.43|
71131403|NCT03350815|141766398|OTHER|Statistical hypothesis tests were not performed for this study|Odds Ratio (OR)|1.31|||||TWO_SIDED|95.0|0.49|3.46||Odds ratio and 95% confidence interval for odds ratio are from a logistic regression model with treatment (2 treatment groups), TNF-alpha inhibitor status (naive, inadequate responder) and Week 16 body weight (kg) as explanatory variables.|Regression, Logistic|||Statistical analysis (logistic regression) of ASAS40 response by visit - in Treatment Period 2 (nonresponder imputation) (FAS)||3.46|0.49|
71131404|NCT03350815|141766399|OTHER|Statistical hypothesis tests were not performed for this study|Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.44|2.41||Odds ratio and 95% confidence interval for odds ratio are from a logistic regression model with treatment (2 treatment groups), TNF-alpha inhibitor status(naive, inadequate responder) and Week 16 body weight (kg) as explanatory variables.|Regression, Logistic|||Statistical analysis (logistic regression) of ASAS partial remission response by visit - in Treatment Period 2 (nonresponder imputation) (FAS)||2.41|0.44|
71131405|NCT03350815|141766400|OTHER|Statistical hypothesis tests were not performed for this study|Mean Difference (Final Values)|0.13|||||TWO_SIDED|95.0|-0.74|1.01||Least squares means (LSMs) of the treatment groups, LSM treatment difference and 95% confidence interval for treatment difference are from mixed-effects model repeated measures (MMRM) with treatment, visit and TNF-alpha inhibitor status as factors|Regression, Logistic|||Statistical analysis of change from Week 16 in ASAS-Health Index using MMRM by visit - in Treatment Period 2 (FAS)||1.01|-0.74|
71131406|NCT03350815|141766401|OTHER|Statistical hypothesis tests were not performed for this study|Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-3.62|1.61||Least squares means (LSMs) of the treatment groups, LSM treatment difference and 95% confidence interval for treatment difference are from mixed-effects model repeated measures (MMRM) with treatment, visit and TNF-alpha inhibitor status as factors|Regression, Logistic|||||1.61|-3.62|
71131407|NCT02936843|141766413|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|2-sided||TTEST, two sided||||0.41
71131408|NCT01835158|141766457|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.012|TWO_SIDED|95.0|0.46|0.95|||Log Rank|||||.95|.46|0.012
71131409|NCT01835158|141766458|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.5|1.26||||||||1.26|0.50|
71131410|NCT00475904|141766462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.547|STANDARD_ERROR_OF_MEAN|0.2709||0.0441|TWO_SIDED|95.0|0.01|1.08||a priori threshold for statistical significance was p\<0.05|ANOVA|||In the initial analysis, the efficacy of the test treatment NP-1 cream was compared with placebo using an analysis of variance (ANOVA). The analysis was conducted using the ITT population to compare the mean changes in pain scores from baseline to endpoint for the 2 treatments; the LOCF approach was employed for patients who did not complete the trial.||1.08|0.01|0.0441
71131411|NCT00475904|141766463|NON_INFERIORITY_OR_EQUIVALENCE|To conclude that the NP-1 was not inferior to gabapentin, the upper limit of the 2-sided 90% CI for the difference between treatments for the endpoint mean pain score was required to be below the non-inferiority margin of 0.70.|Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.2311||0.8409|TWO_SIDED|90.0|-0.33|0.43||To conclude that the NP-1 was not inferior to gabapentin, the upper limit of the 2-sided 90% CI for the difference between treatments for the endpoint mean pain score was required to be below the non-inferiority margin of 0.70.|ANCOVA|||the primary hypothesis of this study was that NP-1 topical cream (amitriptyline 4%/ketamine 2%) administered twice daily in doses of 4 gm for 4 weeks is not inferior to the standard treatment (oral gabapentin 600 mg 3 times daily) for relieving the pain of adult patients with PHN.||0.43|-0.33|0.8409
71131412|NCT00939562|141766464|SUPERIORITY_OR_OTHER||Ratio|102.95||||||90.0|94.74|111.86|||||The adjusted mean differences and 90% confidence intervals (CIs) were exponentiated to provide the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Doxycycline carragenate=Reference, doxycycline monohydrate=Test.|Natural log transformed Cmax was analyzed using a mixed effects model (sequence, period and treatment were fixed effects and subject within sequence was a random effect).||111.86|94.74|
71131413|NCT00939562|141766465|SUPERIORITY_OR_OTHER||Ratio|104.67||||||90.0|98.95|110.73|||||The adjusted mean differences and 90% CIs were exponentiated to provide the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Doxycycline carragenate=Reference, doxycycline monohydrate=Test.|Natural log transformed AUCinf was analyzed using a mixed effects model (sequence, period and treatment were fixed effects and subject within sequence was a random effect).||110.73|98.95|
71131414|NCT05758402|141766489|OTHER||Rate difference|1.21||||0.544|TWO_SIDED|95.0|-2.71|5.13|||Chi-squared||Rate difference = detection rate of PsA in EARP group - detection rate of PsA in routine practice group|||5.13|-2.71|0.544
71131415|NCT05758402|141766490|OTHER|||||||0.256|||||||Chi-squared|||Sensitivity||||0.256
71131416|NCT05758402|141766490|OTHER||||||<|0.001|||||||Chi-squared|||Specificity||||<0.001
71131417|NCT05758402|141766490|OTHER|||||||0.336|||||||Fisher Exact|||Positive Predictive Value (PPV)||||0.336
71131418|NCT05758402|141766490|OTHER|||||||0.49|||||||Chi-squared|||Negative Predictive Value (NPV)||||0.490
71131419|NCT05758402|141766491|OTHER|||||||0.101|||||||Wilcoxon (Mann-Whitney)|||Age characteristics||||0.101
71131420|NCT05758402|141766492|OTHER|||||||0.836|||||||Chi-squared|||Gender characteristics||||0.836
71131421|NCT05758402|141766493|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Body Mass Index (BMI) characteristics||||0.520
71131422|NCT05758402|141766494|OTHER|||||||0.216|||||||Chi-squared|||Drinking history characteristics||||0.216
71131423|NCT05758402|141766494|OTHER|||||||0.719|||||||Chi-squared|||Smoking history characteristics||||0.719
71131424|NCT05758402|141766495|OTHER|||||||0.831|||||||Wilcoxon (Mann-Whitney)|||Duration of Psoriasis (PsO) characteristics||||0.831
71131425|NCT05758402|141766496|OTHER|||||||0.274|||||||Fisher Exact|||Family history of psoriasis (PsO) characteristics||||0.274
71131426|NCT05758402|141766496|OTHER|||||||0.272|||||||Fisher Exact|||Family history of psoriatic arthritis (PsA) characteristics||||0.272
71131427|NCT05758402|141766497|OTHER|||||||0.622|||||||Wilcoxon (Mann-Whitney)|||Psoriasis Area and Severity Index (PASI) score characteristics||||0.622
71131428|NCT05758402|141766498|OTHER||||||<|0.001|||||||Chi-squared|||Status of hard-to-treat area involvement characteristics||||<0.001
71131429|NCT05758402|141766498|OTHER||||||<|0.001|||||||Chi-squared|||Status of musculoskeletal symptoms characteristics||||<0.001
71131430|NCT05758402|141766499|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||NAPSI score of left hand characteristics||||<0.001
71131431|NCT05758402|141766499|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||NAPSI score of right hand characteristics||||0.010
71131432|NCT05758402|141766499|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||NAPSI score of left foot characteristics||||0.001
71131433|NCT05758402|141766499|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||NAPSI score of right foot characteristics||||<0.001
71131434|NCT05758402|141766499|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Total NAPSI score characteristics||||0.001
71131435|NCT05758402|141766500|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||SJC66 total joint count characteristics||||<0.001
71131436|NCT05758402|141766500|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||TJC68 total joint count characteristics||||<0.001
71131437|NCT05758402|141766500|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||SJC66/TJC68 total joint count characteristics||||<0.001
71131438|NCT05758402|141766501|OTHER|||||||0.043|||||||Fisher Exact|||Heart diseases||||0.043
71131439|NCT05758402|141766501|OTHER|||||||1|||||||Fisher Exact|||Stroke||||1.000
71131440|NCT05758402|141766501|OTHER|||||||1|||||||Fisher Exact|||Diabetes||||1.000
71131441|NCT05758402|141766501|OTHER|||||||0.019|||||||Chi-squared|||Hyperlipidemia||||0.019
71131442|NCT05758402|141766501|OTHER|||||||0.073|||||||Chi-squared|||Hypertension||||0.073
71131443|NCT05758402|141766501|OTHER|||||||0.377|||||||Fisher Exact|||Fatty liver||||0.377
71131444|NCT02211456|141766503|SUPERIORITY||Mean Difference (Final Values)|3.7|||<|0.05|TWO_SIDED|95.0|1.0|6.3|||Mixed Models Analysis|||The data derived from this study was complex multi-level data with errors due to patient-level and intra-patient repeat factors. Accordingly, we used generalized multi-level modelling (GLMM) with random effects.||6.3|1|<0.05
71131445|NCT00095173|141766504|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||0.0002|TWO_SIDED|95.0|0.16|0.59|||Log Rank||Abatacept over placebo|||0.59|0.16|0.0002
71131446|NCT00095173|141766505|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
71131447|NCT02708355|141766525|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.028||||0.0442|TWO_SIDED|95.0|1.001|1.055|||Regression, Logistic|||Association between percentage of time with intragastric pH\>4 and relief of 24 -hour heartburn was assessed using logistic regression model with relief of 24- hour heartburn at Day 14 as dependent variable and change in percentage of time with intragastric pH\>4 as the independent variable, controlling for age, sex, and body mass index (BMI).||1.055|1.001|0.0442
71131448|NCT01153724|141766603|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|113.29|STANDARD_DEVIATION|13.6||0.0101|TWO_SIDED|90.0|105.893|121.197||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol||121.197|105.893|0.0101
71131449|NCT01153724|141766604|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|108.78|STANDARD_DEVIATION|15.5||0.0009|TWO_SIDED|90.0|101.59|116.487||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol for the category Olodaterol||116.487|101.590|0.0009
71131450|NCT01153724|141766604|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean|85.98|STANDARD_DEVIATION|19.4||0.0711|TWO_SIDED|90.0|79.277|93.253||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol for the category Olodaterol glucuronide||93.253|79.277|0.0711
71131451|NCT01153724|141766607|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|114.83|STANDARD_DEVIATION|33.5||0.1539|TWO_SIDED|90.0|99.94|131.932||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol for the category Olodaterol||131.932|99.940|0.1539
71131452|NCT01153724|141766607|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|74.48|STANDARD_DEVIATION|1.068||0.8574|TWO_SIDED|90.0|66.619|83.266||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol for the category Olodaterol glucuronide||83.266|66.619|0.8574
71131453|NCT01153724|141766608|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|74.08|STANDARD_DEVIATION|14.6||0.9646|TWO_SIDED|90.0|69.105|79.418||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol||79.418|69.105|0.9646
71131454|NCT00870545|141766661|SUPERIORITY_OR_OTHER|||||||0.003||||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Change in scores measured across three time points (baseline, 6 and 12 months)||||.003
71131455|NCT00870545|141766662|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Analysis was change in score over time (baseline, 6 and 12 months)||||.20
71131456|NCT00870545|141766663|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Change in scores measured across three time points (baseline, 6 and 12 months)||||<.001
71131457|NCT00870545|141766664|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Analysis was change in score over time (baseline, 6 months, 12 months)||||.26
71131458|NCT00870545|141766665|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Analysis was change in scores over time (baseline, 6 months, and 12 months)||||.04
71131459|NCT00870545|141766666|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Analysis was change in score over time (baseline, 6 months, and 12 months)||||.10
71131460|NCT04230213|141766667|EQUIVALENCE|Equivalence was to be determined if the 90% confidence interval of the geometric mean ratio falls within the 80% to 125% range.|Geometric mean ratio (percentage)|102.56|||||TWO_SIDED|90.0|89.78|117.17|||||Analysis was performed using analysis of variance (ANOVA) model.|||117.17|89.78|
71131461|NCT04230213|141766668|EQUIVALENCE|Equivalence was to be determined if the 90% confidence interval of the geometric mean ratio falls within the 80% to 125% range.|Geometric mean ratio (Percentage)|105.31|||||TWO_SIDED|90.0|89.16|124.39|||||Analysis was performed using ANOVA model.|||124.39|89.16|
71131462|NCT00524472|141766698|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.62||||0.0043|TWO_SIDED|95.0|0.39|0.97||"P-values for combined sites: significant if P \< 0.0085 for efficacy. Adjusted for interim analysis.~Confidence intervals adjusted for interim analysis."|Cochran-Mantel-Haenszel||Hyperinsulinemic-normoglycemic clamp|||0.97|0.39|0.0043
71131463|NCT00524472|141766699|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92||||0.29|TWO_SIDED|95.0|0.75|1.13|||Cochran-Mantel-Haenszel||HN vs. standard|||1.13|0.75|0.29
71131464|NCT00524472|141766700|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.99|TWO_SIDED|95.0|0.91|1.21|||Regression, Cox|||||1.21|0.91|0.99
71131465|NCT00524472|141766701|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.13||||0.025|TWO_SIDED|95.0|0.98|1.31|||Regression, Cox||HN vs. Standard|||1.31|0.98|0.025
71131466|NCT00524472|141766702|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.52||||0.12|TWO_SIDED|95.0|0.74|3.11|||Cochran-Mantel-Haenszel||HN vs. standard|||3.11|0.74|0.12
71131467|NCT00524472|141766703|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88||||0.085|TWO_SIDED|95.0|0.72|1.07|||Cochran-Mantel-Haenszel||HN vs. Standard|||1.07|0.72|0.085
71131468|NCT02508428|141766704|EQUIVALENCE|Differences in survivorship among the Marathon and Enduron liners were evaluated with a Log Rank test.|||||<|0.001||||||A p-value of 0.05 was used as the threshold for statistical significance.|Log Rank|||Survivorship was evaluated using liner revision for wear/osteolysis as an endpoint using a Kaplan-Meier analysis.||||<0.001
71131469|NCT02508428|141766705|EQUIVALENCE|"Since the null hypothesis assumed that the wear rates were not different, Equivalence has been specified for the Type of Statistical Test"|Mean Difference (Net)|0.22|||<|0.001|TWO_SIDED|95.0|0.17|0.27||A p-value of 0.05 was used as the threshold for statistical significance.|t-test, 2 sided|||||0.27|0.17|<0.001
71131470|NCT02508428|141766706|EQUIVALENCE|"Since the null hypothesis assumed that the incidences of clinically important osteolysis were not different, Equivalence has been specified for the Type of Statistical Test"|Risk Ratio (RR)|0.04|||<|0.001|TWO_SIDED|95.0|0.006|0.3||A p-value of 0.05 was used as the threshold for statistical significance.|Fisher Exact|||||0.30|0.006|<0.001
71131471|NCT02508428|141766707|EQUIVALENCE|"Since the null hypothesis assumed that the rate of satisfaction among the groups were not different, Equivalence has been specified for the Type of Statistical Test"||||||0.48||||||A p-value of 0.05 was used as the threshold for statistical significance.|Fisher Exact|||Since there were no patients with Marathon liners who were unsatisfied with the outcome of their hip replacement, a relative risk and the associated confidence interval could not be calculated.||||0.48
71131472|NCT02508428|141766708|EQUIVALENCE|"Since the null hypothesis assumed that the Harris Hip Scores among the groups were not different, Equivalence has been specified for the Type of Statistical Test"||||||0.4||||||A p-value of 0.05 was used as the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||.40
71131473|NCT02178696|141766709|OTHER||Mean Difference (Net)|0.12|STANDARD_DEVIATION|0.31|<|0.001|TWO_SIDED|95.0|0.016|0.23||A p\<0.001 was established for regions a priori hypothesized (e.g. nucleus accumbens).|t-test, 2 sided|||||0.23|0.016|<0.001
71131474|NCT02748070|141766736|OTHER|||||||0.819|||||||t-test, 2 sided|||Comparison of baseline and 1 week||||0.819
71131475|NCT02748070|141766736|OTHER|||||||0.665|||||||t-test, 2 sided|||Comparison of baseline and 1 month||||0.665
70860315|NCT01227564|141206987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.5044|TWO_SIDED|95.0|-0.063|0.127||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.127|-0.063|0.5044
71131476|NCT02748070|141766736|OTHER|||||||0.071|||||||t-test, 2 sided|||Comparison of baseline and 3 months||||0.071
71131477|NCT02748070|141766736|OTHER|||||||0.097|||||||t-test, 2 sided|||Comparison of baseline and 6 months||||0.097
71131478|NCT02748070|141766737|OTHER|||||||0.376|||||||t-test, 2 sided|||Comparison of baseline and 1 week||||0.376
71131479|NCT02748070|141766737|OTHER|||||||0.685|||||||t-test, 2 sided|||Comparison of baseline and 1 month||||0.685
71131480|NCT02748070|141766737|OTHER|||||||0.388|||||||t-test, 2 sided|||Comparison of baseline and 3 months||||0.388
71131481|NCT02748070|141766737|OTHER|||||||0.233|||||||t-test, 2 sided|||Comparison of baseline and 6 months||||0.233
71131482|NCT00928694|141766738|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence bounds = (0.80, 1.25) Study Primary Hypothesis: Single 160 mg doses of the U.S. and UK formulations of fenofibrate following consumption of a standard breakfast are bioequivalent (the true geometric mean ratios (GMRs) \[U.S./UK\] for the AUC(0 to infinity) and maximum plasma concentration (Cmax) of fenofibric acid after administration of the U.S. and UK formulations of fenofibrate with food are contained in the interval \[0.80, 1.25\]).|Geometric Mean Ratio|0.96||||||90.0|0.9|1.02||||||||1.02|0.90|
71131483|NCT00928694|141766739|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence bounds = (0.80, 1.25) Study Primary Hypothesis: Single 160 mg doses of the U.S. and UK formulations of fenofibrate following consumption of a standard breakfast are bioequivalent (the true GMRs \[U.S./UK\] for the AUC(0 to infinity) and Cmax of fenofibric acid after administration of the U.S. and UK formulations of fenofibrate with food are contained in the interval \[0.80, 1.25\]).|Geometric Mean Ratio|0.98||||||90.0|0.9|1.06||||||||1.06|0.90|
71131484|NCT00534976|141766740|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-4.65||||0.02||95.0|||||ANOVA||Montelukast minus placebo|||||0.020
71131485|NCT00534976|141766741|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-4.33||||0.005||95.0|||||ANOVA||Montelukast minus placebo|||||0.005
71131486|NCT00534976|141766742|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-120.86||||0.022||95.0|||||ANOVA||Montelukast minus placebo|||||0.022
70860316|NCT01227564|141206988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.7687|TWO_SIDED|95.0|-0.23|0.17||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.17|-0.23|0.7687
70860317|NCT01227564|141206988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.6804|TWO_SIDED|95.0|-0.16|0.24||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.24|-0.16|0.6804
70860318|NCT01227564|141206988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9452|TWO_SIDED|95.0|-0.17|0.18||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.18|-0.17|0.9452
70860319|NCT01227564|141206988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.8825|TWO_SIDED|95.0|-0.27|0.23||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.23|-0.27|0.8825
70860320|NCT01227564|141206988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.8791|TWO_SIDED|95.0|-0.28|0.24||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.24|-0.28|0.8791
71131487|NCT00534976|141766743|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-122.82||||0.013||95.0|||||ANOVA||Montelukast minus placebo|||||0.013
71131488|NCT00534976|141766744|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-8.27||||0.064||95.0|||||ANOVA||Montelukast minus placebo|||||0.064
71131489|NCT00534976|141766745|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-7.06||||0.054||95.0|||||ANOVA||Montelukast minus Placebo|||||0.054
71131490|NCT00534976|141766746|SUPERIORITY_OR_OTHER_LEGACY||Difference in Proportions|-1.6||||1||95.0||||P-value provided is for comparison between the two proportions: Montelukast versus placebo.|McNemar||Montelukast minus placebo|||||1.000
71131491|NCT00534976|141766747|SUPERIORITY_OR_OTHER_LEGACY||Difference in Proportions|-3.2||||||95.0|||||||Montelukast minus placebo|||||
71131492|NCT03004911|141766793|SUPERIORITY|||||||0.74|||||||t-test, 2 sided|||||||0.740
71131493|NCT03004911|141766794|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||||||0.890
71131494|NCT03004911|141766795|SUPERIORITY|||||||0.747|||||||t-test, 2 sided|||||||0.747
71131495|NCT03004911|141766796|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
71131496|NCT03004911|141766797|SUPERIORITY|||||||0.459|||||||t-test, 2 sided|||||||0.459
71131497|NCT02451917|141766826|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18randomized to sequence INPH/IGlar) provided 90% power to detect a mean difference of 0.7% in the primary endpoint(A1c), considering a 15% dropout rate and assuming an SD of 0.85%, and a type I error of 5%.||||||0.00045||||||The intention-to-treat population consisted of all randomized participants.|ANOVA|||A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power to detect a mean difference of 0.7% in the primary endpoint (A1c), considering a 15% dropout rate and assuming an SD of 0.85%, and a type I error of 5%. Test for data normality (Kolmogorov-Smirnov statistics) was performed at baseline for each sequence of the therapy.||||0.00045
71131498|NCT02451917|141766827|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%. Test for data normality (Kolmogorov-Smirnov statistics) was performed at baseline for each sequence of the therapy.|number of total events per patient|0.0||||0.35|TWO_SIDED|||||Analysis of covariance (ANOVA) model - total hypoglycemic events per patient during 24 weeks|ANOVA||The calculated value for the estimation parameter was zero, since the best treatment option for those with diabetes is reach a good glycemic control without hypoglycemia.|Analysis of covariance (ANOVA) model - total hypoglycemic events per patient during 24 weeks||||0.35
71131499|NCT02451917|141766827|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.|number of nocturnal events per patient|0.0||||0.047|TWO_SIDED|||||Analysis of covariance (ANOVA) model - number of nocturnal hypoglycemic events per patient during 24 weeks|ANOVA||The calculated value for the estimation parameter was zero, since the best treatment option for those with diabetes is reach a good glycemic control without hypoglycemia.|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||0.047
71131500|NCT02451917|141766828|NON_INFERIORITY_OR_EQUIVALENCE|t-test was applied to compare percentages of the time spent in hypoglycemia, hyperglycemia and euglycemia on CGM readings.|||||<|0.05|||||||t-test, 1 sided|||A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||<0.05
71131501|NCT02451917|141766829|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||||0.668|||||||ANOVA|||A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||0.668
71131502|NCT02451917|141766830|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18r andomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||||0.999|||||||ANOVA|||A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18r andomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||0.999
71131503|NCT02451917|141766831|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||||0.999|||||||ANOVA|||A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||0.999
71131504|NCT02451917|141766832|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||||0.994|||||||ANOVA|||A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||0.994
71131505|NCT04737278|141766843|OTHER|test of the hypothesis that the score on day 28 is different from the baseline score in the Placebo group|||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71131506|NCT04737278|141766843|OTHER|||||||0.01|||||||t-test, 2 sided|||test of the hypothesis that the score on day 28 is different than the baseline score||||0.01
71131507|NCT04737278|141766844|OTHER|||||||0.15|||||||t-test, 2 sided|||Day 28. Between group comparison was made using ANCOVA accounting for baseline values, no significance at p\<0.05. Within group comparisons were made using the paired Student's t test.||||0.15
70860321|NCT01227564|141206988|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.02||||0.8628|TWO_SIDED|95.0|-0.24|0.2||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.20|-0.24|0.8628
71131508|NCT04737278|141766845|OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
70947223|NCT03732820|141395053|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0025|TWO_SIDED|95.0|0.64|0.9|||Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||0.90|0.64|0.0025
71131509|NCT04737278|141766845|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||comparison made between placebo and Cunermuspir at baseline||||0.03
71131510|NCT04737278|141766845|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||comparison made at day 28||||0.01
71131511|NCT04737278|141766845|OTHER|||||||0.07|||||||t-test, 2 sided|||comparison between baseline and day 28||||0.07
71131512|NCT04737278|141766846|OTHER|||||||0.54|||||||Fisher Exact|||base line between group comparisons||||0.54
71131513|NCT04737278|141766846|OTHER|||||||0.14|||||||Fisher Exact|||||||0.14
71131514|NCT04737278|141766847|OTHER|||||||0.54|||||||ANCOVA|||||||0.54
71131515|NCT04737278|141766848|OTHER||||||<|0.01|||||||ANCOVA|||The original report from KGK Synergize/Science did not specify if the results are ANCOVA or a between group comparison at 2ay 28||||<0.01
71131516|NCT04737278|141766849|OTHER|||||||0.31|||||||ANCOVA|||||||0.31
71131517|NCT04737278|141766850|OTHER|||||||0.48|||||||ANCOVA|||||||0.48
71131518|NCT04737278|141766851|OTHER|||||||0.84|||||||ANCOVA|||||||0.84
71131519|NCT04737278|141766852|OTHER|||||||0.63|||||||ANCOVA|||||||0.63
71131520|NCT04737278|141766853|OTHER|||||||0.05|||||||ANCOVA|||||||0.05
71131521|NCT04737278|141766854|OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
71131522|NCT04737278|141766855|OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
71131523|NCT04737278|141766856|OTHER|||||||0.48|||||||ANCOVA|||||||0.48
71131524|NCT04737278|141766857|OTHER|||||||0.06|||||||ANCOVA|||||||0.06
71131525|NCT04737278|141766858|OTHER|||||||0.02|||||||ANCOVA|||||||0.02
71131526|NCT04737278|141766859|OTHER|||||||0.03|||||||ANCOVA|||||||0.03
71131527|NCT04737278|141766859|OTHER|||||||0.05|||||||t-test, 2 sided|||comparison of neutrophils from baseline to day 28||||0.05
71131528|NCT04737278|141766860|OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
71131529|NCT04737278|141766861|OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||comparison of baseline values||||0.47
71131530|NCT04737278|141766861|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||comparison performed on data from day 28||||0.24
71131531|NCT04737278|141766862|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||comparison of eosinophil counts at day 28||||0.11
71131532|NCT04737278|141766863|OTHER|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||The day 28 basophil counts on day 28 were compared between the two arms of this study.||||0.98
71131533|NCT04737278|141766864|OTHER|||||||0.025||||||This p value is for the treatment source. Visits (p=0.422) and visits x treatments (p=0.153) did not meet the threshold of significance.|ANOVA|||"All other statistical analyses were performed by KGK Synergize. This site was used to determine that the NLR were normally distributed https://www.gigacalculator.com/calculators/normality-test-calculator.php~Because these data fulfilled the assumptions of ANOVA, the data were analyzed using this site:~http://vassarstats.net/anova2u.html"||||0.025
71131534|NCT04737278|141766865|OTHER|||||||0.06|||||||t-test, 2 sided|||Comparison of blood glucose in the Cunermuspir arm between enrollment baseline and day 28.||||0.06
71131535|NCT04737278|141766865|OTHER|||||||0.04|||||||t-test, 2 sided|||Comparison of enrollment baseline blood glucose and day 28 in the placebo arm||||0.04
71131536|NCT04737278|141766865|OTHER|||||||0.92|||||||ANCOVA|||||||0.92
71131537|NCT04737278|141766866|OTHER|||||||0.51|||||||ANCOVA|||||||0.51
71131538|NCT04737278|141766867|OTHER|||||||0.38|||||||ANCOVA|||||||0.38
71131539|NCT04737278|141766868|OTHER|||||||0.01|||||||ANCOVA|||||||0.01
71131540|NCT04737278|141766869|OTHER|||||||0.23|||||||ANCOVA|||||||0.23
71131541|NCT04737278|141766869|OTHER|||||||0.18|||||||t-test, 2 sided|||||||0.18
71131542|NCT04737278|141766869|OTHER|||||||0.01|||||||t-test, 2 sided|||Blood sodium concentration between baseline and day 28 in the Placebo group.||||0.01
71131543|NCT04737278|141766870|OTHER|||||||0.58|||||||ANCOVA|||||||0.58
71131544|NCT04737278|141766870|OTHER||||||<|0.001|||||||t-test, 2 sided|||comparison of blood potassium concentration upon enrollment and day 28 in the Cunermuspir participants||||<0.001
71131545|NCT04737278|141766870|OTHER||||||<|0.001|||||||t-test, 2 sided|||comparison of blood potassium concentrations from enrollment to day 28 in participants in the Placebo arm.||||<0.001
71131546|NCT04737278|141766871|OTHER|||||||0.87|||||||ANCOVA|||||||0.87
71131547|NCT04737278|141766871|OTHER|||||||0.003|||||||t-test, 2 sided|||comparison between baseline and day 28 chloride concentrations in the Cunermuspir group||||0.003
71131548|NCT04737278|141766871|OTHER|||||||0.003|||||||t-test, 2 sided|||comparison of blood chloride concentrations between baseline and day 28 in Placebo Arm participants||||0.003
71131549|NCT04737278|141766872|OTHER|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||Bilirubin concentrations between Placebo and Cunermuspir compared at day 28||||0.36
71131550|NCT04737278|141766872|OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Signed-Rank||comparison of bilirubin concentrations between baseline and day 28 in the Cunermuspir Arm||||0.72
71131551|NCT04737278|141766872|OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||bilirubin concentrations compared between baseline and Day 28 in the Placebo Arm||||0.35
71131552|NCT04737278|141766873|OTHER|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
71131553|NCT04737278|141766873|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||comparison between baseline and day 28 values in Cunermuspir group||||0.4
71131554|NCT04737278|141766873|OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||comparison between baseline and day 28 values for the Placebo Arm||||0.8
71131555|NCT04737278|141766874|OTHER|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||comparison of AST enzyme activity in blood on day 28 between Cunermuspir and Placebo||||0.62
71131556|NCT04737278|141766874|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||baseline to day 28 comparison||||0.24
71131557|NCT04737278|141766874|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||baseline to day 28 comparison of AST activity in Placebo group||||0.11
71131558|NCT04737278|141766875|OTHER|||||||0.11||||||Comparison of GGT activities in blood of two arms: Cunermuspir and Placebo on Day 28|Wilcoxon (Mann-Whitney)|||comparison between placebo and Cunermuspir at day 28||||0.11
71131559|NCT04737278|141766875|OTHER|||||||0.01|||||||Wilcoxon Signed Rank|||Comparison of GGT activities in participants' blood at baseline and on day 28||||0.01
71131560|NCT04737278|141766875|OTHER|||||||0.97|||||||Wilcoxon Signed-Rank|||Comparison of GGT activity in blood between Placebo Arm participants at baseline and on day 28||||0.97
71131561|NCT04737278|141766876|OTHER|||||||0.03|||||||ANCOVA|||Between group comparisons were made using ANCOVA||||0.03
71131562|NCT04737278|141766876|OTHER|||||||0.1|||||||t-test, 2 sided|||comparison of baseline with day 28||||0.10
71131563|NCT04737278|141766876|OTHER|||||||0.89|||||||t-test, 2 sided|||comparison between baseline and day 28 serum copper concentrations in the Placebo Arm||||0.89
71131564|NCT00660179|141766909|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.704||||0.0108|TWO_SIDED|97.5|0.516|0.96|||Log Rank|||||0.960|0.516|0.0108
71131565|NCT00660179|141766909|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.547|||<|0.0001|TWO_SIDED|97.5|0.392|0.762|||Log Rank|||||0.762|0.392|<0.0001
71131566|NCT00660179|141766910|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.669||||0.0146|TWO_SIDED|97.5|0.462|0.97|||Log Rank|||||0.970|0.462|0.0146
71131567|NCT00660179|141766910|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|97.5|0.335|0.747|||Log Rank|||||0.747|0.335|<0.0001
71131568|NCT00660179|141766911|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.971||||0.9249|TWO_SIDED|97.5|0.477|1.976|||Log Rank|||||1.976|0.477|0.9249
71131569|NCT00660179|141766911|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.638||||0.2037|TWO_SIDED|97.5|0.287|1.418|||Log Rank|||||1.418|0.287|0.2037
71131570|NCT00660179|141766912|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.046||||0.8312|TWO_SIDED|97.5|0.653|1.673|||Log Rank|||||1.673|0.653|0.8312
71131571|NCT00660179|141766912|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.771||||0.2509|TWO_SIDED|97.5|0.464|1.282|||Log Rank|||||1.282|0.464|0.2509
71131572|NCT01504412|141766918|SUPERIORITY||Hazard Ratio (HR)|-0.42||||0.1995|TWO_SIDED|95.0|-0.99|0.15||Dunnett method was used for adjustment of multiple testing.|ANCOVA|||||0.15|-0.99|0.1995
71131573|NCT01504412|141766918|SUPERIORITY||Hazard Ratio (HR)|-0.37||||0.2886|TWO_SIDED|95.0|-0.93|0.2||Dunnett method was used for adjustment of multiple testing.|ANCOVA|||||0.20|-0.93|0.2886
71131574|NCT01504412|141766918|SUPERIORITY||Hazard Ratio (HR)|-0.3||||0.4704|TWO_SIDED|95.0|-0.87|0.27||Dunnett method was used for adjustment of multiple testing.|ANCOVA|||||0.27|-0.87|0.4704
71131575|NCT01504412|141766919|SUPERIORITY||Least squares mean difference|-5.2||||0.0691|TWO_SIDED|95.0|-10.8|0.4|||ANCOVA|||This analysis assessed placebo vs DS-5565 10 mg/day for the visual analog scale.||0.4|-10.8|0.0691
71131576|NCT01504412|141766919|SUPERIORITY||Least squares mean difference|-5.4||||0.0577|TWO_SIDED|95.0|-10.9|0.2|||ANCOVA|||This analysis assessed placebo vs DS-5565 20 mg/day for the visual analog scale.||0.2|-10.9|0.0577
71131577|NCT01504412|141766919|SUPERIORITY||Least squares mean difference|-7.4||||0.0093|TWO_SIDED|95.0|-13.0|-1.8|||ANCOVA|||This analysis assessed placebo vs DS-5565 30 mg/day for the visual analog scale.||-1.8|-13.0|0.0093
71131578|NCT01449006|141766920|SUPERIORITY_OR_OTHER|||||||0.05||||||This pilot study was conducted to generate effect sizes for a potential larger investigation. The study design and small sample size had limited power to detect a statistically significant effect at p\<0.05, so no p-value threshold was strictly set.|Mixed Models Analysis|41 data points included (control n=14; maraviroc: n=27); n=1 control did not attend 12-month visit.||The primary outcome was analysed using a mixed-effect regression model with arm and time as fixed linear effects, arm\*time interaction as a non-linear fixed effect and participant as a random effect to account for participant attrition.||||0.05
71131579|NCT01449006|141766920|SUPERIORITY_OR_OTHER||Cohen's d|0.77|||||TWO_SIDED|90.0|-0.19|1.71|||||Positive value reflects improved neurocognitive functioning in maraviroc arm compared to control arm.|Clinical relevance of the effect size observed at 6-months was assessed by generating Cohen's d statistic and 90% confidence interval (CI) around the estimate.||1.71|-0.19|
71131580|NCT01449006|141766920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55|||||TWO_SIDED|90.0|-0.47|1.55|||||Positive value reflects improved neurocognitive functioning in maraviroc arm compared to control arm.|Clinical relevance of the effect size observed at 12-months was assessed by generating Cohen's d statistic and 90%CI around the estimate.||1.55|-0.47|
71131581|NCT01449006|141766921|SUPERIORITY_OR_OTHER|||||||0.82|||||||ANOVA|||Change in CSF neopterin levels was analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.82
71131582|NCT01449006|141766922|SUPERIORITY_OR_OTHER|||||||0.49|||||||ANOVA|||Change in NAA/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.49
71131583|NCT01449006|141766922|SUPERIORITY_OR_OTHER|||||||0.94|||||||ANOVA|||Change in Cr/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.94
71131584|NCT01449006|141766922|SUPERIORITY_OR_OTHER|||||||0.8|||||||ANOVA|||Change in Cho/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.80
70947224|NCT03732820|141395054|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.7456|TWO_SIDED|95.0|0.75|1.5|||Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||1.50|0.75|0.7456
71131585|NCT01449006|141766922|SUPERIORITY_OR_OTHER|||||||0.72|||||||ANOVA|||Change in mIo/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.72
71131586|NCT01449006|141766923|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANOVA|||Change in NAA/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.95
71131587|NCT01449006|141766923|SUPERIORITY_OR_OTHER|||||||0.66|||||||ANOVA|||Change in Cr/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.66
71131588|NCT01449006|141766923|SUPERIORITY_OR_OTHER|||||||0.56|||||||ANOVA|||Change in Cho/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.56
71131589|NCT01449006|141766923|SUPERIORITY_OR_OTHER|||||||0.29|||||||ANOVA|||Change in mIo/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.29
70947225|NCT03732820|141395055|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.3099|TWO_SIDED|95.0|0.82|1.79|||Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||1.79|0.82|0.3099
71131590|NCT01449006|141766923|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANOVA|||Change in Glx/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.95
71131591|NCT05292131|141766938|EQUIVALENCE|Bioequivalence (BE) was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 0.8 to 1.25 for AUC.|Geometric Mean Ratio (percentage [%])|97.5|||||TWO_SIDED|90.0|90.2|105.4||||||||105.40|90.20|
71131592|NCT05292131|141766939|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 0.8 to 1.25 for AUC0-t.|Geometric Mean Ratio (%)|97.05|||||TWO_SIDED|90.0|90.1|104.55||||||||104.55|90.10|
71131593|NCT05292131|141766940|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 0.8 to 1.25 for Cmax.|Geometric Mean Ratio (%)|96.21|||||TWO_SIDED|90.0|88.6|104.47||||||||104.47|88.60|
71131594|NCT05292131|141766943|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 0.8 to 1.25 for t½.|Geometric Mean Ratio (%)|101.13|||||TWO_SIDED|90.0|94.18|108.59||||||||108.59|94.18|
71131595|NCT05292131|141766944|EQUIVALENCE|The point estimate and the 90% CI for the median treatment differences for tmax was computed according to the Hodges-Lehmann's method.|Hodges-Lehman Estimate|0.4897|||||TWO_SIDED|90.0|-0.0073|0.9567||||||||0.9567|-0.0073|
71131596|NCT01979952|141766978|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.176|STANDARD_ERROR_OF_MEAN|6.237|||TWO_SIDED|95.0|-9.227|15.579|||ANCOVA|As per the Clinical Trial Protocol, this is an exploratory trial hence p-values were not calculated.||Analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline HRCT QLF score as covariate||15.579|-9.227|
71131597|NCT01979952|141766979|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.519|STANDARD_ERROR_OF_MEAN|6.3829|||TWO_SIDED|95.0|-10.258|15.296|||ANCOVA|As per the Clinical Trial Protocol, this is an exploratory trial hence p-values were not calculated||Analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline HRCT QLF score as covariate||15.296|-10.258|
71131598|NCT01979952|141766980|SUPERIORITY_OR_OTHER||Adjusted mean difference|69.0|STANDARD_ERROR_OF_MEAN|39.182|||TWO_SIDED|95.0|-8.74|146.75|||Mixed Models Analysis|As per the Clinical Trial Protocol, this is an exploratory trial hence p-values were not calculated.||Mixed Model for Repeated Measures (MMRM) model with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC, baseline FVC-by-visit and random effect for patient. Within-patient errors are modelled by unstructured covariance matrix.||146.75|-8.74|
71131599|NCT01979952|141766981|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.36|||||TWO_SIDED|95.0|-0.29|5.0|||Mixed Models Analysis|As per the Clinical Trial Protocol, this is an exploratory trial hence p-values were not calculated.||MMRM model with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC, baseline FVC-by-visit and random effect for patient. Within-patient errors are modelled by unstructured covariance matrix.||5.00|-0.29|
71131600|NCT01979952|141766983|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.05|STANDARD_ERROR_OF_MEAN|2.434|||TWO_SIDED|95.0|-4.89|4.79|||Mixed Models Analysis|||MMRM model included treatment, visit, baseline value, treatment-by-visit and baseline-by-visit as fixed effects and patient as random effect. Unstructured covariance was assumed for within patient variation||4.79|-4.89|
71131601|NCT01979952|141766984|SUPERIORITY_OR_OTHER||Adjusted mean difference|17.94|STANDARD_ERROR_OF_MEAN|16.19|||TWO_SIDED|95.0|-14.21|50.09|||Mixed Models Analysis|||MMRM model included treatment, visit, baseline value, treatment-by-visit and baseline-by-visit as fixed effects and patient as random effect. Unstructured covariance was assumed for within patient variation||50.09|-14.21|
71131602|NCT01979952|141766985|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.89|||||TWO_SIDED|95.0|-1.47|11.25|||Mixed Models Analysis|||MMRM model included treatment, visit, baseline value, treatment-by-visit and baseline-by-visit as fixed effects and patient as random effect. Unstructured covariance was assumed for within patient variation||11.25|-1.47|
71131603|NCT05438576|141766990|SUPERIORITY||Odds Ratio (OR)|2.12||||0.032|TWO_SIDED|95.0|1.05|4.27|||Regression, Logistic|||||4.27|1.05|0.032
71131604|NCT05438576|141766995|SUPERIORITY||Odds Ratio (OR)|1.1||||0.621|TWO_SIDED|95.0|0.74|1.64|||Regression, Logistic|||||1.64|0.74|0.621
71131605|NCT00465088|141767009|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05|Mixed Models Analysis|||An n = 81 for niacin extended-release with simvastatin and n = 54 for atorvastatin would provide \> 99% power to detect a 13% increase in HDL-C with niacin extended-release with simvastatin relative to atorvastatin, assuming an SD of 16%||||<0.001
70860322|NCT01227564|141206988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.7843|TWO_SIDED|95.0|-0.35|0.26||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.26|-0.35|0.7843
70860323|NCT01227564|141206988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.0857|TWO_SIDED|95.0|-0.04|0.6||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.60|-0.04|0.0857
71131606|NCT00555672|141767042|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|27.3|||||TWO_SIDED|95.0|13.3|45.5|||Fisher Exact|Exact Method based on the F Distribution.||||45.5|13.3|
71131607|NCT01053988|141767045|SUPERIORITY_OR_OTHER||Least squares mean difference|0.053||||0.04|TWO_SIDED|95.0|0.003|0.104||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.104|0.003|0.040
71131608|NCT01053988|141767045|SUPERIORITY_OR_OTHER||Least squares mean difference|0.103|||<|0.001|TWO_SIDED|95.0|0.052|0.153|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.153|0.052|<0.001
71131609|NCT01053988|141767045|SUPERIORITY_OR_OTHER||Least squares mean difference|0.192|||<|0.001|TWO_SIDED|95.0|0.141|0.243||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.243|0.141|<0.001
71131610|NCT01053988|141767045|SUPERIORITY_OR_OTHER||Least squares mean difference|0.173|||<|0.001|TWO_SIDED|95.0|0.123|0.224|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.224|0.123|<0.001
71131611|NCT01053988|141767045|SUPERIORITY_OR_OTHER||Least squares mean difference|0.12|||<|0.001|TWO_SIDED|95.0|0.07|0.17|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.170|0.070|<0.001
71131612|NCT01053988|141767045|SUPERIORITY_OR_OTHER||Least squares mean difference|0.09|||<|0.001|TWO_SIDED|95.0|0.039|0.14||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.140|0.039|<0.001
71131613|NCT01053988|141767045|SUPERIORITY_OR_OTHER||Least squares mean difference|0.071||||0.006|TWO_SIDED|95.0|0.021|0.121||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.121|0.021|0.006
71131614|NCT01053988|141767046|SUPERIORITY_OR_OTHER||Least squares mean difference|0.033||||0.241|TWO_SIDED|95.0|-0.022|0.088|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.088|-0.022|0.241
71131615|NCT01053988|141767046|SUPERIORITY_OR_OTHER||Least squares mean difference|0.067||||0.017|TWO_SIDED|95.0|0.012|0.121|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.121|0.012|0.017
71131616|NCT01053988|141767046|SUPERIORITY_OR_OTHER||Least squares mean difference|0.129|||<|0.001|TWO_SIDED|95.0|0.074|0.184||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.184|0.074|<0.001
71131617|NCT01053988|141767046|SUPERIORITY_OR_OTHER||Least squares mean difference|0.115|||<|0.001|TWO_SIDED|95.0|0.06|0.169|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.169|0.060|<0.001
71131618|NCT01053988|141767046|SUPERIORITY_OR_OTHER||Least squares mean difference|0.082||||0.003|TWO_SIDED|95.0|0.028|0.136||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.136|0.028|0.003
71131619|NCT01053988|141767046|SUPERIORITY_OR_OTHER||Least squares mean difference|0.062||||0.025|TWO_SIDED|95.0|0.008|0.117||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.117|0.008|0.025
71131620|NCT01053988|141767046|SUPERIORITY_OR_OTHER||Least squares mean difference|0.048||||0.082|TWO_SIDED|95.0|-0.006|0.102|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.102|-0.006|0.082
71131621|NCT04759157|141767051|SUPERIORITY|||||||0.3|||||||mixed model|||||||.30
71131622|NCT04759157|141767052|SUPERIORITY||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|2.05||0.206|TWO_SIDED|95.0|-6.63|1.43|||Mixed Models Analysis||This estimate is comparing intervention to control from baseline to 3 month for both patients and partners|We conducted multilevel models evaluating sleep disturbance score by assessment, group and patient versus partner status.||1.43|-6.63|.206
71131623|NCT03375489|141767085|EQUIVALENCE|Equivalence was established for patient-reported quality of life if the 90% confidence interval for the estimated difference in means was within the margin of ±4 points on the Functional Assessment of Cancer Therapy - Lung Questionnaire.|Mean Difference (Final Values)|2.0||||0.04|TWO_SIDED|90.0|0.1|3.9||The a priori threshold for statistical significance was p\<0.05.|Regression, Linear|||The difference in week-24 means between groups was estimated using a linear regression model with a main effect for group assignment and controlling for baseline Functional Assessment of Cancer Therapy - Lung Questionnaire scores.||3.9|0.1|0.04
71131624|NCT03375489|141767086|EQUIVALENCE|Equivalence was established for patient-reported communication with their clinicians about their end-of-life care preferences if the 90% confidence interval for the estimated difference in proportions was within the margin of ±8%.|Estimated Difference in Proportions|3.1||||0.26|TWO_SIDED|90.0|-1.8|8.1||Bonferroni-adjusted p-value|binomial generalized estimating equation|||The difference between groups in the proportions of patients reporting that they communicated with their clinicians about their end-of-life care preferences was estimated using a binomial generalized estimating equation model with robust standard errors, the identity link function, and a main effect for group assignment.||8.1|-1.8|0.26
71131625|NCT03375489|141767087|EQUIVALENCE|Equivalence was established for patient length of stay in hospice if the 90% confidence interval for the estimated difference in mean days was within the margin of ±6 days.|Mean Difference (Final Values)|0.2||||0.46|TWO_SIDED|90.0|-7.0|7.4||Bonferroni-adjusted p-value|Regression, Linear|||The difference in mean length of stay in hospice between groups was estimated using a linear regression model with a main effect for group assignment.||7.4|-7.0|0.46
71131626|NCT03375489|141767088|SUPERIORITY||Difference in estimated proportions|-13.0|||<|0.001|TWO_SIDED|95.0|-17.6|-8.6||Bonferroni-adjusted p-value|binomial generalized estimating equation|||The proportion of palliative care visits with caregiver participation was compared using a binomial generalized estimating equation model with robust standard errors, the identity link function, and a main effect for group assignment.||-8.6|-17.6|<0.001
71131627|NCT03375489|141767089|SUPERIORITY||Mean Difference (Final Values)|0.3|||>|0.99|TWO_SIDED|95.0|-1.0|1.7||Bonferroni-adjusted p-value|Regression, Linear|||The difference in week-24 means between groups was estimated using a linear regression model with a main effect for group assignment.||1.7|-1.0|>0.99
71131628|NCT03375489|141767090|SUPERIORITY||Mean Difference (Final Values)|0.4|||>|0.99|TWO_SIDED|95.0|-1.5|2.3||Bonferroni-adjusted p-value|Regression, Linear|||The difference in week-24 means between groups was estimated using a linear regression model with a main effect for group assignment.||2.3|-1.5|>0.99
71131629|NCT00145574|141767121|SUPERIORITY_OR_OTHER|||||||0.1122|||||||ANCOVA|||The primary null hypotheses were tested sequentially in the following order: 1) no difference between the high-dose colesevelam HCl and placebo for percent change in LDL-C from study baseline to Week 8 endpoint with the last observation carried forward (LOCF) and 2) no difference between the low-dose colesevelam HCl and placebo for percent change in LDL-C from study baseline to Week 8 endpoint with LOCF. The hypotheses were tested at a 2-sided significance level of 5%.||||0.1122
71131630|NCT00145574|141767121|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71131631|NCT00145574|141767122|SUPERIORITY_OR_OTHER|||||||0.526||95.0|||||ANCOVA|||||||0.5260
71131632|NCT00145574|141767122|SUPERIORITY_OR_OTHER|||||||0.0085||95.0|||||ANCOVA|||||||0.0085
71131633|NCT00145574|141767123|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71131634|NCT00145574|141767123|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||ANCOVA|||||||0.0008
71131635|NCT00145574|141767124|SUPERIORITY_OR_OTHER|||||||0.0155||95.0|||||ANCOVA|||||||0.0155
71131636|NCT00145574|141767124|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71131637|NCT00145574|141767125|SUPERIORITY_OR_OTHER|||||||0.3482||95.0|||||ANCOVA|||||||0.3482
71131638|NCT00145574|141767125|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|||||||0.0006
71131639|NCT00145574|141767126|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANCOVA|||||||0.0002
71131640|NCT00145574|141767126|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71131641|NCT00145574|141767127|SUPERIORITY_OR_OTHER|||||||0.7433||95.0|||||ANCOVA|||||||0.7433
71131642|NCT00145574|141767127|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||ANCOVA|||||||0.0003
71131643|NCT01320202|141767141|SUPERIORITY_OR_OTHER||Difference in LS Means between SFP & PBO|3.6|STANDARD_ERROR_OF_MEAN|1.4||0.011|TWO_SIDED|||||LS Mean (SE) and p-value are from ANCOVA model with baseline Hgb as covariate. Model also includes indicator variable for baseline ESA dose stratum.|ANCOVA|||||||0.011
71131644|NCT00635882|141767156|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||"Analysis of covariance (ANCOVA) model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."||||<0.001
71131645|NCT00635882|141767156|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||ANCOVA|||"ANCOVA model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."||||0.003
71131646|NCT00635882|141767156|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||ANCOVA|||"ANCOVA model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."||||0.018
71131647|NCT00635882|141767157|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||"ANCOVA model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."||||<0.001
70860324|NCT01227564|141206988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.3878|TWO_SIDED|95.0|-0.15|0.39||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.39|-0.15|0.3878
71131648|NCT00635882|141767157|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||ANCOVA|||"ANCOVA model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."||||0.002
71131649|NCT00635882|141767157|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||ANCOVA|||"ANCOVA model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."||||0.002
71131650|NCT00635882|141767158|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024|||||||ANCOVA|||"ANCOVA model with treatment and baseline eosinophils as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline EOS as a covariate."||||0.024
71131651|NCT00635882|141767158|SUPERIORITY_OR_OTHER_LEGACY|||||||0.051|||||||ANCOVA|||"ANCOVA model with treatment and baseline eosinophils as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline EOS as a covariate."||||0.051
71131652|NCT00635882|141767158|SUPERIORITY_OR_OTHER_LEGACY|||||||0.336|||||||ANCOVA|||"ANCOVA model with treatment and baseline eosinophils as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline EOS as a covariate."||||0.336
71131653|NCT00635882|141767159|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12|||||||ANCOVA|Analysis applies to Mean Change from Baseline to Day 15.||"ANCOVA model with treatment and baseline PD15 as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline PD15 as a covariate."||||0.120
71131654|NCT00635882|141767159|SUPERIORITY_OR_OTHER_LEGACY|||||||0.103|||||||ANCOVA|Analysis applies to Mean Change from Baseline to Day 15.||"ANCOVA model with treatment and baseline PD15 as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline PD15 as a covariate."||||0.103
71131655|NCT00635882|141767159|SUPERIORITY_OR_OTHER_LEGACY|||||||0.048|||||||ANCOVA|Analysis applies to Mean Change from Baseline to Day 15.||"ANCOVA model with treatment and baseline PD15 as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline PD15 as a covariate."||||0.048
71131656|NCT00635882|141767160|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way analysis of variance (ANOVA) model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.018
71131657|NCT00635882|141767160|SUPERIORITY_OR_OTHER_LEGACY|||||||0.261|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.261
71131658|NCT00635882|141767160|SUPERIORITY_OR_OTHER_LEGACY|||||||0.334|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.334
71131659|NCT00635882|141767161|SUPERIORITY_OR_OTHER_LEGACY|||||||0.037|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.037
71131660|NCT00635882|141767161|SUPERIORITY_OR_OTHER_LEGACY|||||||0.643|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.643
71131661|NCT00635882|141767161|SUPERIORITY_OR_OTHER_LEGACY|||||||0.963|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.963
71131662|NCT00635882|141767162|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||<0.001
71131663|NCT00635882|141767162|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.002
71131664|NCT00635882|141767162|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||<0.001
71131665|NCT00635882|141767163|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||<0.001
71131666|NCT00635882|141767163|SUPERIORITY_OR_OTHER_LEGACY|||||||0.057|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.057
71131667|NCT00635882|141767163|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.005
71131668|NCT02305238|141767171|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) mean difference|-0.4|||||TWO_SIDED|95.0|-3.8|3.0||||||||3.0|-3.8|
71131669|NCT02305238|141767172|SUPERIORITY_OR_OTHER_LEGACY||Mantel-Haenszel (MH) adjusted difference|-0.9|||||TWO_SIDED|95.0|-5.7|4.0||||||||4.0|-5.7|
71131670|NCT02305238|141767173|SUPERIORITY_OR_OTHER_LEGACY||MH adjusted difference|-1.4|||||TWO_SIDED|95.0|-12.7|9.8||||||||9.8|-12.7|
71131671|NCT02305238|141767174|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-5.8|||||TWO_SIDED|95.0|-24.3|12.7||||||||12.7|-24.3|
71131672|NCT02305238|141767175|SUPERIORITY_OR_OTHER_LEGACY||MH adjusted difference|1.0|||||TWO_SIDED|95.0|-10.6|12.7||||||||12.7|-10.6|
71131673|NCT01100775|141767212|SUPERIORITY|||||||0.898|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean Target Hits between Galantamine and Placebo Arms||||0.898
71131674|NCT01100775|141767212|SUPERIORITY|||||||0.701|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean False Alarms between Galantamine and Placebo Arms||||0.701
71131675|NCT01100775|141767212|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean Target Hits between Galantamine and Placebo Arms||||0.16
71131676|NCT01100775|141767212|SUPERIORITY|||||||0.701|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean False Alarms between Galantamine and Placebo Arms||||0.701
71131677|NCT01100775|141767213|SUPERIORITY|||||||0.161|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean Target Reaction Time between Galantamine and Placebo Arms||||0.161
71131678|NCT01100775|141767213|SUPERIORITY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean False Alarm Reaction Time between Galantamine and Placebo Arms||||0.028
71131679|NCT01100775|141767213|SUPERIORITY|||||||0.899|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean Target Reaction Time between Galantamine and Placebo Arms||||0.899
71131680|NCT01100775|141767213|SUPERIORITY|||||||0.521|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean False Alarms Reaction Time between Galantamine and Placebo Arms||||0.521
71131681|NCT01100775|141767214|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Comparison of the mean total amount offered during the trust game between the galantamine and placebo groups||||0.67
71131682|NCT01100775|141767215|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||Comparison of the mean correct responses between galantamine and placebo||||0.32
71131683|NCT01100775|141767216|SUPERIORITY|||||||0.659|||||||Wilcoxon (Mann-Whitney)|||Comparison of the number of correct response on Trial 1 between galantamine and placebo||||0.659
71131684|NCT01100775|141767216|SUPERIORITY|||||||0.541|||||||Wilcoxon (Mann-Whitney)|||Comparison of the number of correct response on Trial 2 between galantamine and placebo||||0.541
71131685|NCT01100775|141767216|SUPERIORITY|||||||0.838|||||||Wilcoxon (Mann-Whitney)|||Comparison of the number of correct response on Trial 3 between galantamine and placebo||||0.838
71131686|NCT01100775|141767217|SUPERIORITY|||||||0.548|||||||Wilcoxon (Mann-Whitney)|||A comparison the mean correct responses between galantamine and placebo||||0.548
71131687|NCT01100775|141767218|SUPERIORITY|||||||0.871|||||||Wilcoxon (Mann-Whitney)|||||||0.871
71131688|NCT01100775|141767219|SUPERIORITY|||||||0.626|||||||Wilcoxon (Mann-Whitney)|||Comparison of Overall Affect between galantamine and placebo||||0.626
71131689|NCT01100775|141767219|SUPERIORITY|||||||0.234|||||||Wilcoxon (Mann-Whitney)|||Comparison of Overall Social Skill between galantamine and placebo||||0.234
71131690|NCT01100775|141767220|SUPERIORITY|||||||0.797|||||||Wilcoxon (Mann-Whitney)|||Comparison of Facial Affect Total Responses between galantamine and placebo||||0.797
71131691|NCT01100775|141767220|SUPERIORITY|||||||0.669|||||||Wilcoxon (Mann-Whitney)|||Comparison of Facial Affect Total Hits between galantamine and placebo||||0.669
71131692|NCT01100775|141767220|SUPERIORITY|||||||0.668|||||||Wilcoxon (Mann-Whitney)|||Comparison of Facial Affect Total False Alarms between galantamine and placebo||||0.668
71131693|NCT04677504|141767225|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.51|1.14|||Regression, Cox|||"Stratified analysis. Stratification factors are: Location of primary tumor (iCCA vs.~eCCA vs. GBC), Geographic region (Asia vs. Rest of the World)."||1.14|0.51|
71131694|NCT04677504|141767226|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8857|TWO_SIDED|95.0|0.64|1.47|||Log Rank|||"Stratified analysis. Stratification factors are: Location of primary tumor (iCCA vs.~eCCA vs. GBC), Geographic region (Asia vs. Rest of the World)."||1.47|0.64|0.8857
71131695|NCT04677504|141767230|SUPERIORITY|Stratified analysis. Stratification factors are: Location of primary tumor (iCCA vs. eCCA vs. GBC), Geographic region (Asia vs. Rest of the World).|Hazard Ratio (HR)|1.56|||||TWO_SIDED|95.0|0.93|2.63|||Regression, Cox|||Quality of Life||2.63|0.93|
71131696|NCT04677504|141767230|SUPERIORITY|Stratified analysis. Stratification factors are: Location of primary tumor (iCCA vs. eCCA vs. GBC), Geographic region (Asia vs. Rest of the World).|Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.48|1.36|||Regression, Cox|||Physical Function Scale||1.36|0.48|
71131697|NCT04677504|141767230|SUPERIORITY|Stratified analysis. Stratification factors are: Location of primary tumor (iCCA vs. eCCA vs. GBC), Geographic region (Asia vs. Rest of the World).|Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.68|1.85|||Regression, Cox|||Role Function Scale||1.85|0.68|
71131698|NCT00112125|141767245|NON_INFERIORITY|The primary safety analysis was a test of the non-inferiority of CCM therapy compared to OMT with respect to the proportion of subjects experiencing death or hospitalization within 50 weeks using the Blackwelder non-inferiority test12 with a prespecified non-inferiority margin of 0.125.||||||0.31|||||||Fisher Exact|||||||0.31
71131699|NCT00112125|141767246|NON_INFERIORITY|The noninferiority margin was selected to be 12.5% and α was set at .05, which resulted in a sample size of 198 subjects per group. A percentage of subjects (∼7%) were expected to be lost to followup, so that a total sample size of 428 subjects (214 per group) was selected.||||||0.125|||||||Blackwelder|||||||0.125
71131700|NCT03543137|141767253|EQUIVALENCE|Bioequivalence was determined if the 90% CIs of the GMRs for AUC0-t fell completely within the 0.80 - 1.25 range.|Geometric mean ratio|0.95|||||TWO_SIDED|90.0|0.88|1.02|||||GMR= (Prototype mini Lozenge/ Nicorette mini Lozenge)|||1.02|0.88|
71131701|NCT03543137|141767254|EQUIVALENCE|Bioequivalence was determined if the 90% CIs of the GMRs for AUC0-inf fell completely within the range.|Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.88|1.01|||||GMR = (Prototype mini Lozenge/Nicorette mini Lozenge)|||1.01|0.88|
71131702|NCT03543137|141767259|EQUIVALENCE|Bioequivalence was determined if the 90% CIs of the GMRs for Cmax fell completely within the range.|Geometric Mean Ratio|0.97|||||TWO_SIDED|90.0|0.9|1.04|||||GMR = (Prototype mini Lozenge/Nicorette mini Lozenge)|||1.04|0.90|
71131703|NCT00445770|141767260|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Based on rank transformed data: rank of change = rank baseline+treatment +pooled study center+prior methotrexate use. If overall treatment effect statistically significant, 3 pairwise comparisons conducted, otherwise no further testing was made.|ANCOVA|||It was estimated that with 180 participants per group, there would be 81% power for the overall test. With this sample size and 0.05 (2-sided) type I error, there was 88% power to detect a 1.33 difference for the change of mTSS from baseline to 52 weeks between the etanercept 25 mg twice weekly group and Methotrexate group, assuming that the common standard deviation of the change of mTSS from baseline was 4.||||<0.0001
71131704|NCT00445770|141767260|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||||||<0.0001
71131705|NCT00445770|141767260|NON_INFERIORITY_OR_EQUIVALENCE|An outcome showing that etanercept 10 mg was superior to methotrexate and the presence of numerical difference ≤0.5 mTSS units between etanercept 25 mg and etanercept 10 mg would support non-inferiority for the 2 etanercept treatments.||||||0.2634|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||||||0.2634
71131706|NCT00445770|141767261|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||||||<0.0001
71131707|NCT00445770|141767261|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||||||<0.0001
71131708|NCT00445770|141767261|SUPERIORITY_OR_OTHER|||||||0.2248|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||||||0.2248
71131709|NCT00445770|141767262|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24||||<0.0001
71131710|NCT00445770|141767262|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24||||<0.0001
71131711|NCT00445770|141767262|SUPERIORITY_OR_OTHER|||||||0.726|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24||||0.7260
71131712|NCT00445770|141767262|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52||||<0.0001
71131713|NCT00445770|141767262|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52||||<0.0001
71131714|NCT00445770|141767262|SUPERIORITY_OR_OTHER|||||||0.5717|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52||||0.5717
71131715|NCT00445770|141767263|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24||||<0.0001
71131716|NCT00445770|141767263|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24||||0.0013
71131717|NCT00445770|141767263|SUPERIORITY_OR_OTHER|||||||0.0186|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24||||0.0186
71131718|NCT00445770|141767263|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52||||<0.0001
71131719|NCT00445770|141767263|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52||||0.0006
71131720|NCT00445770|141767263|SUPERIORITY_OR_OTHER|||||||0.1123|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52||||0.1123
71131721|NCT00445770|141767264|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=0.5||||<0.0001
71131722|NCT00445770|141767264|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=0.5||||0.0002
71131723|NCT00445770|141767264|SUPERIORITY_OR_OTHER|||||||0.3022|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=0.5||||0.3022
71131724|NCT00445770|141767264|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=3.0||||0.0001
71131725|NCT00445770|141767264|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=3.0||||0.0002
71131726|NCT00445770|141767264|SUPERIORITY_OR_OTHER|||||||0.312|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=3.0||||0.3120
71131727|NCT00445770|141767264|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use.|Cochran-Mantel-Haenszel|||Week 52 for progression \<=SDD||||0.0010
71131728|NCT00445770|141767264|SUPERIORITY_OR_OTHER|||||||0.0285|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=SDD||||0.0285
71131729|NCT00445770|141767264|SUPERIORITY_OR_OTHER|||||||0.0433|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=SDD||||0.0433
71131730|NCT00445770|141767265|SUPERIORITY_OR_OTHER|||||||0.0032|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.0032
71131731|NCT00445770|141767265|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
71131732|NCT00445770|141767265|SUPERIORITY_OR_OTHER|||||||0.1224|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.1224
71131733|NCT00445770|141767265|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
71131734|NCT00445770|141767265|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
71131735|NCT00445770|141767265|SUPERIORITY_OR_OTHER|||||||0.8037|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.8037
71131736|NCT00445770|141767265|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
71131737|NCT00445770|141767265|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
71131738|NCT00445770|141767265|SUPERIORITY_OR_OTHER|||||||0.5495|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.5495
70947226|NCT03732820|141395056|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.3212|TWO_SIDED|95.0|0.55|1.22|||Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||1.22|0.55|0.3212
70947227|NCT03732820|141395057|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0534|TWO_SIDED|95.0|0.59|0.99|||Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||0.99|0.59|0.0534
71131739|NCT00445770|141767265|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
71131740|NCT00445770|141767265|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
71131741|NCT00445770|141767265|SUPERIORITY_OR_OTHER|||||||0.4948|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.4948
70947228|NCT00992992|141395060|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants|56.0|||||TWO_SIDED|95.0|37.0|75.0|||||The estimated value reflects the percentage of participants with unconfirmed complete response (CR).|||75|37|
70947229|NCT00992992|141395060|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants|8.0|||||TWO_SIDED|95.0|0.0|19.0|||||The estimated value reflects the percentage of participants with unconfirmed complete response unconfirmed (CRu).|||19|0|
70947230|NCT00992992|141395060|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants|20.0|||||TWO_SIDED|95.0|4.0|36.0|||||The estimated value reflects the percentage of participants with unconfirmed partial response.|||36|4|
70947231|NCT00832000|141395077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.68|STANDARD_DEVIATION|1.24|<|0.001|TWO_SIDED|95.0|-2.66|-0.706|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model (n=57). When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.706|-2.66|<0.001
70947232|NCT00832000|141395077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.68|STANDARD_DEVIATION|1.24||0.04||95.0|-3.85|-0.139|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model (n=57). When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.139|-3.85|0.04
70947233|NCT00832000|141395078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63|STANDARD_DEVIATION|1.19|<|0.001|TWO_SIDED|95.0|-2.0|-1.26|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||-1.26|-2.00|<0.001
70947234|NCT00832000|141395079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|STANDARD_DEVIATION|1.27|<|0.001|TWO_SIDED|95.0|-1.67|-0.861|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.861|-1.67|<0.001
70947235|NCT00832000|141395080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.918|STANDARD_DEVIATION|1.29|<|0.001|TWO_SIDED|95.0|-1.3|-0.532|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.532|-1.30|<0.001
70947236|NCT00832000|141395081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.109|STANDARD_DEVIATION|0.563|<|0.001|TWO_SIDED|95.0|-0.177|-0.056|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.056|-0.177|<0.001
70947237|NCT00832000|141395082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.54|STANDARD_DEVIATION|13.1||0.09|TWO_SIDED|95.0|-0.68|9.75|||wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||9.75|-0.680|0.09
70947238|NCT00832000|141395083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.568|STANDARD_DEVIATION|0.6|<|0.001|TWO_SIDED|95.0|-0.812|-0.325|||Wilcoxon (Mann-Whitney)||Residual standard deviation.|P value indicates significance level of the Wilcoxon test associated with mexiletine effect from the linear mixed effects model. The Wilcoxon test was substituted because the outcome is not continuous and therefore normality of the residuals is not satisfied. All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.325|-0.812|<0.001
71131742|NCT00445770|141767265|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
71131743|NCT00445770|141767265|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
71131744|NCT00445770|141767265|SUPERIORITY_OR_OTHER|||||||0.4663|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.4663
71131745|NCT00445770|141767265|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
71131746|NCT00445770|141767265|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
71131747|NCT00445770|141767265|SUPERIORITY_OR_OTHER|||||||0.9357|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.9357
71131748|NCT00445770|141767265|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
71131749|NCT00445770|141767265|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
71131750|NCT00445770|141767265|SUPERIORITY_OR_OTHER|||||||0.7439|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.7439
71131751|NCT00445770|141767265|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
71131752|NCT00445770|141767265|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
71131753|NCT00445770|141767265|SUPERIORITY_OR_OTHER|||||||0.8611|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.8611
71131754|NCT00445770|141767265|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
71131755|NCT00445770|141767265|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
71131756|NCT00445770|141767265|SUPERIORITY_OR_OTHER|||||||0.6731|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.6731
71131757|NCT00445770|141767265|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
71131758|NCT00445770|141767265|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
71131759|NCT00445770|141767265|SUPERIORITY_OR_OTHER|||||||0.2616|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.2616
71131760|NCT00445770|141767265|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
71131761|NCT00445770|141767265|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.0001
71131762|NCT00445770|141767265|SUPERIORITY_OR_OTHER|||||||0.1158|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.1158
71131763|NCT00445770|141767266|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
71131764|NCT00445770|141767266|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
71131765|NCT00445770|141767266|SUPERIORITY_OR_OTHER|||||||0.4237|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.4237
71131766|NCT00445770|141767266|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
71131767|NCT00445770|141767266|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.0002
71131768|NCT00445770|141767266|SUPERIORITY_OR_OTHER|||||||0.5738|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.5738
71131769|NCT00445770|141767266|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
71131770|NCT00445770|141767266|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
71131771|NCT00445770|141767266|SUPERIORITY_OR_OTHER|||||||0.1606|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.1606
71131772|NCT00445770|141767266|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
71131773|NCT00445770|141767266|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.0016
71131774|NCT00445770|141767266|SUPERIORITY_OR_OTHER|||||||0.2412|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.2412
71131775|NCT00445770|141767266|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
71131776|NCT00445770|141767266|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
71131777|NCT00445770|141767266|SUPERIORITY_OR_OTHER|||||||0.5882|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.5882
71131778|NCT00445770|141767266|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
71131779|NCT00445770|141767266|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.0001
71131780|NCT00445770|141767266|SUPERIORITY_OR_OTHER|||||||0.2257|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.2257
71131781|NCT00445770|141767266|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
71131782|NCT00445770|141767266|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.0003
71131783|NCT00445770|141767266|SUPERIORITY_OR_OTHER|||||||0.2075|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.2075
71131784|NCT00445770|141767266|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
71131785|NCT00445770|141767266|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.0050
71131786|NCT00445770|141767266|SUPERIORITY_OR_OTHER|||||||0.0461|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.0461
71131787|NCT00445770|141767266|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.0002
71131788|NCT00445770|141767266|SUPERIORITY_OR_OTHER|||||||0.0101|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.0101
71131789|NCT00445770|141767266|SUPERIORITY_OR_OTHER|||||||0.2351|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.2351
71131790|NCT00445770|141767266|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0002
71131791|NCT00445770|141767266|SUPERIORITY_OR_OTHER|||||||0.1179|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.1179
71131792|NCT00445770|141767266|SUPERIORITY_OR_OTHER|||||||0.0214|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0214
71131793|NCT00445770|141767266|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
71131794|NCT00445770|141767266|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.0790
71131795|NCT00445770|141767266|SUPERIORITY_OR_OTHER|||||||0.0168|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.0168
71131796|NCT00445770|141767267|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
71131797|NCT00445770|141767267|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
71131798|NCT00445770|141767267|SUPERIORITY_OR_OTHER|||||||0.6337|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.6337
71131799|NCT00445770|141767267|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
71131800|NCT00445770|141767267|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
71131801|NCT00445770|141767267|SUPERIORITY_OR_OTHER|||||||0.7407|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.7407
71131802|NCT00445770|141767267|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
71131803|NCT00445770|141767267|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
71131804|NCT00445770|141767267|SUPERIORITY_OR_OTHER|||||||0.3473|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.3473
71131805|NCT00445770|141767267|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
71131806|NCT00445770|141767267|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
71131807|NCT00445770|141767267|SUPERIORITY_OR_OTHER|||||||0.7529|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.7529
71131808|NCT00445770|141767267|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
70860325|NCT01227564|141206988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.8918|TWO_SIDED|95.0|-0.39|0.45||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.45|-0.39|0.8918
70860326|NCT01227564|141206988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.1233|TWO_SIDED|95.0|-0.09|0.76||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.76|-0.09|0.1233
70860327|NCT01227564|141206988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.3302|TWO_SIDED|95.0|-0.19|0.55||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.55|-0.19|0.3302
70860328|NCT01227564|141206989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.65||||0.1597|TWO_SIDED|95.0|-0.67|3.97||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||3.97|-0.67|0.1597
70860329|NCT01227564|141206989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55||||0.213|TWO_SIDED|95.0|-4.01|0.91||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.91|-4.01|0.2130
70860330|NCT01227564|141206989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.9616|TWO_SIDED|95.0|-2.06|2.16||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||2.16|-2.06|0.9616
70860331|NCT01227564|141206989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.78||||0.2143|TWO_SIDED|95.0|-1.06|4.62||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||4.62|-1.06|0.2143
71131809|NCT00445770|141767267|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
71131810|NCT00445770|141767267|SUPERIORITY_OR_OTHER|||||||0.5216|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.5216
70872062|NCT02155608|141229485|SUPERIORITY|||||||0.007||||||Time2: F = 7.45, df = 1/209.|Mixed Models Analysis|||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||.007
71131811|NCT00445770|141767267|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
71131812|NCT00445770|141767267|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
71131813|NCT00445770|141767267|SUPERIORITY_OR_OTHER|||||||0.1078|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.1078
71131814|NCT00445770|141767267|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
71131815|NCT00445770|141767267|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
71131816|NCT00445770|141767267|SUPERIORITY_OR_OTHER|||||||0.128|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.1280
70860332|NCT01227564|141206989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.87||||0.2151|TWO_SIDED|95.0|-4.87|1.12||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||1.12|-4.87|0.2151
70860333|NCT01227564|141206989|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.05||||0.9704|TWO_SIDED|95.0|-2.61|2.51||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||2.51|-2.61|0.9704
70860334|NCT01227564|141206989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.7857|TWO_SIDED|95.0|-3.0|3.95||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||3.95|-3.00|0.7857
70860335|NCT01227564|141206989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.79||||0.1323|TWO_SIDED|95.0|-6.45|0.87||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.87|-6.45|0.1323
70860336|NCT01227564|141206989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16||||0.4618|TWO_SIDED|95.0|-4.29|1.97||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.97|-4.29|0.4618
70860337|NCT01227564|141206989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.24||||0.2622|TWO_SIDED|95.0|-1.74|6.22||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||6.22|-1.74|0.2622
70860338|NCT01227564|141206989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55||||0.4499|TWO_SIDED|95.0|-5.64|2.55||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.55|-5.64|0.4499
70860339|NCT01227564|141206989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.8454|TWO_SIDED|95.0|-3.21|3.91||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||3.91|-3.21|0.8454
70860340|NCT01227564|141206990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.1796|TWO_SIDED|95.0|-0.18|0.96||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.96|-0.18|0.1796
70947239|NCT00832000|141395084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_DEVIATION|1.083|<|0.001|TWO_SIDED|95.0|-0.633|-0.142|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.142|-0.633|<0.001
71131817|NCT00445770|141767267|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
70947240|NCT00832000|141395085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.313|STANDARD_DEVIATION|0.889|<|0.001|TWO_SIDED|95.0|-0.602|-0.149|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.149|-0.602|<0.001
70947241|NCT00832000|141395086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.464|STANDARD_DEVIATION|0.516|<|0.001|TWO_SIDED|95.0|-0.675|-0.254|||Wilcoxon (Mann-Whitney)||Residual standard deviation.|P value indicates significance level of the Wilcoxon test associated with mexiletine effect from the linear mixed effects model. The Wilcoxon test was substituted because the outcome is not continuous and therefore normality of the residuals is not satisfied. All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.254|-0.675|<0.001
70947242|NCT00832000|141395087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.69|STANDARD_DEVIATION|12.6||0.5|TWO_SIDED|95.0|-3.34|6.73|||wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||6.73|-3.34|0.50
70947243|NCT00832000|141395088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.69|STANDARD_DEVIATION|3.44|<|0.001|TWO_SIDED|95.0|-4.07|-1.3|||wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||-1.30|-4.07|<0.001
70947244|NCT00832000|141395089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.58|STANDARD_DEVIATION|5.35|<|0.001|TWO_SIDED|95.0|3.44|7.72|||wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||7.72|3.44|<0.001
70947245|NCT00832000|141395090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.351|STANDARD_DEVIATION|6.5||0.9|TWO_SIDED|95.0|-5.87|5.17|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||5.17|-5.87|0.90
70947246|NCT00832000|141395090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.4|STANDARD_ERROR_OF_MEAN|6.5||0.03|TWO_SIDED|95.0|0.941|20.6|||wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||20.6|0.941|0.03
70947247|NCT03845075|141395094|SUPERIORITY||LS Mean Difference|3.6||||0.4671|TWO_SIDED|95.0|-6.58|13.78||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 4; Safety set; LOCF||13.78|-6.58|0.4671
70947248|NCT03845075|141395094|SUPERIORITY||LS Mean Difference|10.11||||0.1808|TWO_SIDED|95.0|-5.14|25.36||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 8; Safety set; LOCF||25.36|-5.14|0.1808
70947249|NCT03845075|141395094|SUPERIORITY||LS Mean Difference|4.63||||0.4171|TWO_SIDED|95.0|-7.08|16.33||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 12; Safety set; LOCF||16.33|-7.08|0.4171
70947250|NCT03845075|141395094|SUPERIORITY||LS Mean Difference|5.33||||0.3116|TWO_SIDED|95.0|-5.43|16.1||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 16; Safety set; LOCF||16.10|-5.43|0.3116
70947251|NCT03845075|141395094|SUPERIORITY||LS Mean Difference|5.8||||0.2353|TWO_SIDED|95.0|-4.12|15.72||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 20; Safety set; LOCF||15.72|-4.12|0.2353
70947252|NCT03845075|141395094|SUPERIORITY||LS Mean Difference|5.86||||0.3037|TWO_SIDED|95.0|-5.76|17.48||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24; Safety set; LOCF||17.48|-5.76|0.3037
70947253|NCT03845075|141395095|SUPERIORITY||LS Mean Difference|-1.31||||0.6543|TWO_SIDED|95.0|-7.33|4.72||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 4; Safety set; LOCF||4.72|-7.33|0.6543
70947254|NCT03845075|141395095|SUPERIORITY||LS Mean Difference|0.94||||0.7941|TWO_SIDED|95.0|-6.5|8.38||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 8; Safety set; LOCF||8.38|-6.50|0.7941
70947255|NCT03845075|141395095|SUPERIORITY||LS Mean Difference|-2.0||||0.5937|TWO_SIDED|95.0|-9.72|5.73||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 12; Safety set; LOCF||5.73|-9.72|0.5937
70947256|NCT03845075|141395095|SUPERIORITY||LS Mean Difference|2.56||||0.5423|TWO_SIDED|95.0|-6.11|11.23||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 16; Safety set; LOCF||11.23|-6.11|0.5423
71131818|NCT00445770|141767267|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
71131819|NCT00445770|141767267|SUPERIORITY_OR_OTHER|||||||0.0291|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.0291
71131820|NCT00445770|141767267|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
71131821|NCT00445770|141767267|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
71131822|NCT00445770|141767267|SUPERIORITY_OR_OTHER|||||||0.0729|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.0729
71131823|NCT00445770|141767267|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
71131824|NCT00445770|141767267|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
71131825|NCT00445770|141767267|SUPERIORITY_OR_OTHER|||||||0.0271|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0271
71131826|NCT00445770|141767267|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
71131827|NCT00445770|141767267|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
71131828|NCT00445770|141767267|SUPERIORITY_OR_OTHER|||||||0.0453|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.0453
71131829|NCT00445770|141767268|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
71131830|NCT00445770|141767268|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
71131831|NCT00445770|141767268|SUPERIORITY_OR_OTHER|||||||0.7488|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.7488
71131832|NCT00445770|141767268|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
71131833|NCT00445770|141767268|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
71131834|NCT00445770|141767268|SUPERIORITY_OR_OTHER|||||||0.568|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.5680
71131835|NCT00445770|141767268|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
71131836|NCT00445770|141767268|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
71131837|NCT00445770|141767268|SUPERIORITY_OR_OTHER|||||||0.9241|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.9241
71131838|NCT00445770|141767268|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
71131839|NCT00445770|141767268|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
71131840|NCT00445770|141767268|SUPERIORITY_OR_OTHER|||||||0.7146|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.7146
71131841|NCT00445770|141767268|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
71131842|NCT00445770|141767268|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.0001
71131843|NCT00445770|141767268|SUPERIORITY_OR_OTHER|||||||0.6574|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.6574
71131844|NCT00445770|141767268|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
71131845|NCT00445770|141767268|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.0004
71131846|NCT00445770|141767268|SUPERIORITY_OR_OTHER|||||||0.2936|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.2936
71131847|NCT00445770|141767268|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
71131848|NCT00445770|141767268|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.0005
71131849|NCT00445770|141767268|SUPERIORITY_OR_OTHER|||||||0.2179|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.2179
71131850|NCT00445770|141767268|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
71131851|NCT00445770|141767268|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
71131852|NCT00445770|141767268|SUPERIORITY_OR_OTHER|||||||0.3704|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.3704
71131853|NCT00445770|141767268|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
71131854|NCT00445770|141767268|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
71131855|NCT00445770|141767268|SUPERIORITY_OR_OTHER|||||||0.8047|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.8047
71131856|NCT00445770|141767268|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
71131857|NCT00445770|141767268|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
71131858|NCT00445770|141767268|SUPERIORITY_OR_OTHER|||||||0.5277|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.5277
71131859|NCT00445770|141767268|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
71131860|NCT00445770|141767268|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
71131861|NCT00445770|141767268|SUPERIORITY_OR_OTHER|||||||0.9371|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.9371
71131862|NCT00445770|141767269|SUPERIORITY_OR_OTHER|||||||0.0027|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.0027
71131863|NCT00445770|141767269|SUPERIORITY_OR_OTHER|||||||0.0015|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.0015
71131864|NCT00445770|141767269|SUPERIORITY_OR_OTHER|||||||0.8875|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.8875
71131865|NCT00445770|141767269|SUPERIORITY_OR_OTHER|||||||0.0015|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.0015
71131866|NCT00445770|141767269|SUPERIORITY_OR_OTHER|||||||0.0011|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.0011
71131867|NCT00445770|141767269|SUPERIORITY_OR_OTHER|||||||0.9694|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.9694
71131868|NCT00445770|141767269|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.0020
71131869|NCT00445770|141767269|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.0005
71131870|NCT00445770|141767269|SUPERIORITY_OR_OTHER|||||||0.7271|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.7271
71131871|NCT00445770|141767269|SUPERIORITY_OR_OTHER|||||||0.0235|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.0235
71131872|NCT00445770|141767269|SUPERIORITY_OR_OTHER|||||||0.0061|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.0061
71131873|NCT00445770|141767269|SUPERIORITY_OR_OTHER|||||||0.6427|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.6427
71131874|NCT00445770|141767269|SUPERIORITY_OR_OTHER|||||||0.0036|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.0036
71131875|NCT00445770|141767269|SUPERIORITY_OR_OTHER|||||||0.0029|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.0029
71131876|NCT00445770|141767269|SUPERIORITY_OR_OTHER|||||||0.9713|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.9713
71131877|NCT00445770|141767269|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.0060
71131878|NCT00445770|141767269|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.0060
71131879|NCT00445770|141767269|SUPERIORITY_OR_OTHER|||||||0.9762|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.9762
70872063|NCT02155608|141229485|SUPERIORITY|||||||0.67||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .19, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.67
71131880|NCT00445770|141767269|SUPERIORITY_OR_OTHER|||||||0.0554|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.0554
71131881|NCT00445770|141767269|SUPERIORITY_OR_OTHER|||||||0.0181|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.0181
71131882|NCT00445770|141767269|SUPERIORITY_OR_OTHER|||||||0.6642|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.6642
71131883|NCT00445770|141767269|SUPERIORITY_OR_OTHER|||||||0.0073|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.0073
71131884|NCT00445770|141767269|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.0290
71131885|NCT00445770|141767269|SUPERIORITY_OR_OTHER|||||||0.5919|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.5919
71131886|NCT00445770|141767269|SUPERIORITY_OR_OTHER|||||||0.0371|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.0371
71131887|NCT00445770|141767269|SUPERIORITY_OR_OTHER|||||||0.0346|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.0346
71131888|NCT00445770|141767269|SUPERIORITY_OR_OTHER|||||||0.9955|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.9955
71131889|NCT00445770|141767269|SUPERIORITY_OR_OTHER|||||||0.0187|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0187
71131890|NCT00445770|141767269|SUPERIORITY_OR_OTHER|||||||0.0645|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0645
71131891|NCT00445770|141767269|SUPERIORITY_OR_OTHER|||||||0.592|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.5920
71131892|NCT00445770|141767269|SUPERIORITY_OR_OTHER|||||||0.0095|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.0095
71131893|NCT00445770|141767269|SUPERIORITY_OR_OTHER|||||||0.2112|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.2112
71131894|NCT00445770|141767269|SUPERIORITY_OR_OTHER|||||||0.1649|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.1649
71131895|NCT00445770|141767270|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
71131896|NCT00445770|141767270|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
71131897|NCT00445770|141767270|SUPERIORITY_OR_OTHER|||||||0.8972|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.8972
71131898|NCT00445770|141767270|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
71131899|NCT00445770|141767270|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
71131900|NCT00445770|141767270|SUPERIORITY_OR_OTHER|||||||0.3736|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.3736
71131901|NCT00445770|141767270|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
71131902|NCT00445770|141767270|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
71131903|NCT00445770|141767270|SUPERIORITY_OR_OTHER|||||||0.9324|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.9324
71131904|NCT00445770|141767270|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
70947257|NCT03845075|141395095|SUPERIORITY||LS Mean Difference|1.2||||0.7226|TWO_SIDED|95.0|-5.77|8.16||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 20; Safety set; LOCF||8.16|-5.77|0.7226
70947258|NCT03845075|141395095|SUPERIORITY||LS Mean Difference|1.15||||0.7912|TWO_SIDED|95.0|-7.85|10.16||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24; Safety set; LOCF||10.16|-7.85|0.7912
70947259|NCT03845075|141395096|SUPERIORITY||LS Mean Difference|-1.35||||0.7023|TWO_SIDED|95.0|-8.67|5.97||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 4; Safety set; LOCF||5.97|-8.67|0.7023
70947260|NCT03845075|141395096|SUPERIORITY||LS Mean Difference|-0.48||||0.9012|TWO_SIDED|95.0|-8.58|7.61||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 8; Safety set; LOCF||7.61|-8.58|0.9012
70947261|NCT03845075|141395096|SUPERIORITY||LS Mean Difference|2.14||||0.6138|TWO_SIDED|95.0|-6.63|10.92||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 12; Safety set; LOCF||10.92|-6.63|0.6138
70947262|NCT03845075|141395096|SUPERIORITY||LS Mean Difference|1.23||||0.7889|TWO_SIDED|95.0|-8.26|10.72||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 16; Safety set; LOCF||10.72|-8.26|0.7889
70947263|NCT03845075|141395096|SUPERIORITY||LS Mean Difference|0.3||||0.9536|TWO_SIDED|95.0|-10.34|10.94||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 20; Safety set; LOCF||10.94|-10.34|0.9536
70947264|NCT03845075|141395096|SUPERIORITY||LS Mean Difference|2.7||||0.5551|TWO_SIDED|95.0|-6.72|12.12||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24; Safety set; LOCF||12.12|-6.72|0.5551
70947265|NCT03845075|141395100|SUPERIORITY||LS Mean Difference|-2.52||||0.7782|TWO_SIDED|95.0|-21.23|16.2||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24||16.20|-21.23|0.7782
70947266|NCT03845075|141395100|SUPERIORITY||LS Mean Difference|-7.26||||0.313|TWO_SIDED|95.0|-22.09|7.56||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 48||7.56|-22.09|0.3130
70947267|NCT03845075|141395100|SUPERIORITY||LS Mean Difference|-5.73||||0.4033|TWO_SIDED|95.0|-19.92|8.47||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Week 24 to Week 48||8.47|-19.92|0.4033
70947268|NCT03845075|141395101|SUPERIORITY||LS Mean Difference|-7.5||||0.0325|TWO_SIDED|95.0|-14.29|-0.71||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24||-0.71|-14.29|0.0325
70947269|NCT03845075|141395101|SUPERIORITY||LS Mean Difference|-0.32||||0.9394|TWO_SIDED|95.0|-9.04|8.4||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 48||8.40|-9.04|0.9394
70947270|NCT03845075|141395101|SUPERIORITY||LS Mean Difference|6.91||||0.0135|TWO_SIDED|95.0|1.65|12.18||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Week 24 to Week 28||12.18|1.65|0.0135
70947271|NCT03845075|141395102|SUPERIORITY||LS Mean Difference|-4.17||||0.1048|TWO_SIDED|95.0|-9.31|0.98||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT observed.||0.98|-9.31|0.1048
70947272|NCT03845075|141395102|SUPERIORITY||LS Mean Difference|-0.99||||0.7189|TWO_SIDED|95.0|-6.75|4.77||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 48; mITT observed.||4.77|-6.75|0.7189
70947273|NCT03845075|141395102|SUPERIORITY||LS Mean Difference|3.09||||0.1053|TWO_SIDED|95.0|-0.73|6.91||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Week 24 to Week 48; mITT observed.||6.91|-0.73|0.1053
71131905|NCT00445770|141767270|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
71131906|NCT00445770|141767270|SUPERIORITY_OR_OTHER|||||||0.8982|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.8982
71131907|NCT00445770|141767270|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
71131908|NCT00445770|141767270|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.0007
71131909|NCT00445770|141767270|SUPERIORITY_OR_OTHER|||||||0.318|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.3180
71131910|NCT00445770|141767270|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
71131911|NCT00445770|141767270|SUPERIORITY_OR_OTHER|||||||0.0011|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.0011
71131912|NCT00445770|141767270|SUPERIORITY_OR_OTHER|||||||0.3302|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.3302
71131913|NCT00445770|141767270|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
71131914|NCT00445770|141767270|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.0002
71131915|NCT00445770|141767270|SUPERIORITY_OR_OTHER|||||||0.6563|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.6563
71131916|NCT00445770|141767270|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
71131917|NCT00445770|141767270|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
71131918|NCT00445770|141767270|SUPERIORITY_OR_OTHER|||||||0.8894|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.8894
71131919|NCT00445770|141767270|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
71131920|NCT00445770|141767270|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
71131921|NCT00445770|141767270|SUPERIORITY_OR_OTHER|||||||0.7826|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.7826
71131922|NCT00445770|141767270|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
71131923|NCT00445770|141767270|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0003
71131924|NCT00445770|141767270|SUPERIORITY_OR_OTHER|||||||0.5343|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.5343
71131925|NCT00445770|141767270|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
71131926|NCT00445770|141767270|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
71131927|NCT00445770|141767270|SUPERIORITY_OR_OTHER|||||||0.9313|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.9313
71131928|NCT00445770|141767271|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
71131929|NCT00445770|141767271|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
71131930|NCT00445770|141767271|SUPERIORITY_OR_OTHER|||||||0.8044|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.8044
71131931|NCT00445770|141767271|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
71131932|NCT00445770|141767271|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.0003
71131933|NCT00445770|141767271|SUPERIORITY_OR_OTHER|||||||0.4652|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.4652
71131934|NCT00445770|141767271|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
71131935|NCT00445770|141767271|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
71131936|NCT00445770|141767271|SUPERIORITY_OR_OTHER|||||||0.5612|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.5612
71131937|NCT00445770|141767271|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.0002
71131938|NCT00445770|141767271|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.0002
71131939|NCT00445770|141767271|SUPERIORITY_OR_OTHER|||||||0.9749|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.9749
71131940|NCT00445770|141767271|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.0001
71131941|NCT00445770|141767271|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.0004
71131942|NCT00445770|141767271|SUPERIORITY_OR_OTHER|||||||0.729|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.7290
71131943|NCT00445770|141767271|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
71131944|NCT00445770|141767271|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.0003
71131945|NCT00445770|141767271|SUPERIORITY_OR_OTHER|||||||0.5004|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.5004
71131946|NCT00445770|141767271|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
71131947|NCT00445770|141767271|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
71131948|NCT00445770|141767271|SUPERIORITY_OR_OTHER|||||||0.5727|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.5727
71131949|NCT00445770|141767271|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
71131950|NCT00445770|141767271|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
71131951|NCT00445770|141767271|SUPERIORITY_OR_OTHER|||||||0.6713|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.6713
71131952|NCT00445770|141767271|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
71131953|NCT00445770|141767271|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.0001
71131954|NCT00445770|141767271|SUPERIORITY_OR_OTHER|||||||0.7663|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.7663
71131955|NCT00445770|141767271|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
71131956|NCT00445770|141767271|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0002
71131957|NCT00445770|141767271|SUPERIORITY_OR_OTHER|||||||0.7073|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.7073
71131958|NCT00445770|141767271|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
71131959|NCT00445770|141767271|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.0001
71131960|NCT00445770|141767271|SUPERIORITY_OR_OTHER|||||||0.7973|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.7973
71131961|NCT00445770|141767272|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2||||<0.0001
71131962|NCT00445770|141767272|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2||||<0.0001
71131963|NCT00445770|141767272|SUPERIORITY_OR_OTHER|||||||0.1053|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2||||0.1053
71131964|NCT00445770|141767272|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||<0.0001
71131965|NCT00445770|141767272|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||<0.0001
71131966|NCT00445770|141767272|SUPERIORITY_OR_OTHER|||||||0.0144|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||0.0144
71131967|NCT00445770|141767272|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||<0.0001
71131968|NCT00445770|141767272|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||<0.0001
71131969|NCT00445770|141767272|SUPERIORITY_OR_OTHER|||||||0.1851|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||0.1851
71131970|NCT00445770|141767272|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||<0.0001
71131971|NCT00445770|141767272|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||0.0001
71131972|NCT00445770|141767272|SUPERIORITY_OR_OTHER|||||||0.2883|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||0.2883
71131973|NCT00445770|141767272|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||<0.0001
71131974|NCT00445770|141767272|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||0.0007
71131975|NCT00445770|141767272|SUPERIORITY_OR_OTHER|||||||0.2221|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||0.2221
71131976|NCT00445770|141767272|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||<0.0001
71131977|NCT00445770|141767272|SUPERIORITY_OR_OTHER|||||||0.0147|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||0.0147
71131978|NCT00445770|141767272|SUPERIORITY_OR_OTHER|||||||0.0201|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||0.0201
71131979|NCT00445770|141767272|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||<0.0001
71131980|NCT00445770|141767272|SUPERIORITY_OR_OTHER|||||||0.0036|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||0.0036
71131981|NCT00445770|141767272|SUPERIORITY_OR_OTHER|||||||0.0789|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||0.0789
71131982|NCT00445770|141767272|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||<0.0001
71131983|NCT00445770|141767272|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||0.0008
71131984|NCT00445770|141767272|SUPERIORITY_OR_OTHER|||||||0.1903|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||0.1903
71131985|NCT00445770|141767272|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||<0.0001
71131986|NCT00445770|141767272|SUPERIORITY_OR_OTHER|||||||0.0048|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||0.0048
71131987|NCT00445770|141767272|SUPERIORITY_OR_OTHER|||||||0.1059|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||0.1059
71131988|NCT00445770|141767272|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||<0.0001
71131989|NCT00445770|141767272|SUPERIORITY_OR_OTHER|||||||0.0018|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||0.0018
71131990|NCT00445770|141767272|SUPERIORITY_OR_OTHER|||||||0.2589|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||0.2589
71131991|NCT00445770|141767272|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||<0.0001
71131992|NCT00445770|141767272|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||0.0040
71131993|NCT00445770|141767272|SUPERIORITY_OR_OTHER|||||||0.2326|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||0.2326
71131994|NCT00445770|141767273|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||<0.0001
71131995|NCT00445770|141767273|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||<0.0001
71131996|NCT00445770|141767273|SUPERIORITY_OR_OTHER|||||||0.4751|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||0.4751
71131997|NCT00445770|141767273|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||<0.0001
71131998|NCT00445770|141767273|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||<0.0001
71131999|NCT00445770|141767273|SUPERIORITY_OR_OTHER|||||||0.4653|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||0.4653
71132000|NCT00445770|141767273|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||<0.0001
71132001|NCT00445770|141767273|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||<0.0001
71132002|NCT00445770|141767273|SUPERIORITY_OR_OTHER|||||||0.7953|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||0.7953
71132003|NCT00445770|141767273|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||<0.0001
70947274|NCT03845075|141395103|SUPERIORITY||LS Mean Difference|-3.12||||0.0033|TWO_SIDED|95.0|-5.02|-1.21||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT observed||-1.21|-5.02|0.0033
70947275|NCT03845075|141395103|SUPERIORITY||LS Mean Difference|0.58||||0.6663|TWO_SIDED|95.0|-2.24|3.41||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 48; mITT LOCF||3.41|-2.24|0.6663
70947276|NCT03845075|141395103|SUPERIORITY||LS Mean Difference|3.59||||0.0058|TWO_SIDED|95.0|1.21|5.98||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Week 24 to Week 48; mITT LOCF||5.98|1.21|0.0058
70947277|NCT03845075|141395104|SUPERIORITY||LS Mean Difference|-3.02||||0.0713|TWO_SIDED|95.0|-6.34|0.3||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT observed||0.30|-6.34|0.0713
70947278|NCT03845075|141395104|SUPERIORITY||LS Mean Difference|-2.48||||0.1457|TWO_SIDED|95.0|-5.92|0.96||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 48; mITT LOCF||0.96|-5.92|0.1457
70947279|NCT03845075|141395104|SUPERIORITY||LS Mean Difference|0.85||||0.1837|TWO_SIDED|95.0|-0.45|2.15||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Week 24 to Week 48; mITT LOCF||2.15|-0.45|0.1837
70947280|NCT03845075|141395105|SUPERIORITY||LS Mean Difference|-0.05||||0.7926|TWO_SIDED|95.0|-0.42|0.33||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT LOCF||0.33|-0.42|0.7926
70947281|NCT03845075|141395105|SUPERIORITY||LS Mean Difference|-0.27||||0.2124|TWO_SIDED|95.0|-0.72|0.17||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 48; mITT LOCF||0.17|-0.72|0.2124
70947282|NCT03845075|141395105|SUPERIORITY||LS Mean Difference|-0.14||||0.6084|TWO_SIDED|95.0|-0.72|0.43||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Week 24 to Week 48; mITT LOCF||0.43|-0.72|0.6084
70947283|NCT03845075|141395106|SUPERIORITY||LS Mean Difference|16.0||||0.0905|TWO_SIDED|95.0|-2.85|34.85||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to week 24; mITT observed. (Like to eat something fatty)||34.85|-2.85|0.0905
70947284|NCT03845075|141395106|SUPERIORITY||LS Mean Difference|6.65||||0.6285|TWO_SIDED|95.0|-22.05|35.36||P-value from ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT observed. (Like some meat/fish)||35.36|-22.05|0.6285
70947285|NCT03845075|141395106|SUPERIORITY||LS Mean Difference|-6.81||||0.5884|TWO_SIDED|95.0|-33.05|19.43||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT observed. (Eat something salty).||19.43|-33.05|0.5884
71132004|NCT00445770|141767273|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||<0.0001
71132005|NCT00445770|141767273|SUPERIORITY_OR_OTHER|||||||0.0848|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||0.0848
70872064|NCT02155608|141229485|SUPERIORITY|||||||0.68||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = .17, df = 1/50.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.68
71132006|NCT00445770|141767273|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||<0.0001
71132007|NCT00445770|141767273|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||<0.0001
71132008|NCT00445770|141767273|SUPERIORITY_OR_OTHER|||||||0.6112|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||0.6112
71132009|NCT00445770|141767273|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||<0.0001
70947286|NCT03845075|141395106|SUPERIORITY||LS Mean Difference|2.98||||0.8533|TWO_SIDED|95.0|-30.73|36.68||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT observed. (Eat something sweet).||36.68|-30.73|0.8533
71132010|NCT00445770|141767273|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.0002
71132011|NCT00445770|141767273|SUPERIORITY_OR_OTHER|||||||0.3671|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.3671
71132012|NCT00445770|141767273|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||<0.0001
71132013|NCT00445770|141767273|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||<0.0001
71132014|NCT00445770|141767273|SUPERIORITY_OR_OTHER|||||||0.7618|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||0.7618
71132015|NCT00445770|141767273|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||<0.0001
71132016|NCT00445770|141767273|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||<0.0001
71132017|NCT00445770|141767273|SUPERIORITY_OR_OTHER|||||||0.4358|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||0.4358
71132018|NCT00445770|141767273|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||0.0008
71132019|NCT00445770|141767273|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||<0.0001
71132020|NCT00445770|141767273|SUPERIORITY_OR_OTHER|||||||0.6267|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||0.6267
71132021|NCT00445770|141767273|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||<0.0001
71132022|NCT00445770|141767273|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||0.0004
71132023|NCT00445770|141767273|SUPERIORITY_OR_OTHER|||||||0.3564|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||0.3564
71132024|NCT00445770|141767273|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||0.0007
71132025|NCT00445770|141767273|SUPERIORITY_OR_OTHER|||||||0.0035|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||0.0035
71132026|NCT00445770|141767273|SUPERIORITY_OR_OTHER|||||||0.4749|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||0.4749
71132027|NCT00445770|141767274|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||<0.0001
71132028|NCT00445770|141767274|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||0.0001
71132029|NCT00445770|141767274|SUPERIORITY_OR_OTHER|||||||0.4376|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||0.4376
71132030|NCT00445770|141767274|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||<0.0001
71132031|NCT00445770|141767274|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||<0.0001
71132032|NCT00445770|141767274|SUPERIORITY_OR_OTHER|||||||0.3947|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||0.3947
71132033|NCT00445770|141767274|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||<0.0001
71132034|NCT00445770|141767274|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||<0.0001
71132035|NCT00445770|141767274|SUPERIORITY_OR_OTHER|||||||0.7378|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||0.7378
71132036|NCT00445770|141767274|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||0.0001
71132037|NCT00445770|141767274|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||<0.0001
71132038|NCT00445770|141767274|SUPERIORITY_OR_OTHER|||||||0.568|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||0.5680
71132039|NCT00445770|141767274|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||0.0003
71132040|NCT00445770|141767274|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||<0.0001
71132041|NCT00445770|141767274|SUPERIORITY_OR_OTHER|||||||0.3978|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||0.3978
71132042|NCT00445770|141767274|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||<0.0001
71132043|NCT00445770|141767274|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.0001
71132044|NCT00445770|141767274|SUPERIORITY_OR_OTHER|||||||0.7229|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.7229
71132045|NCT00445770|141767274|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||<0.0001
71132046|NCT00445770|141767274|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||<0.0001
71132047|NCT00445770|141767274|SUPERIORITY_OR_OTHER|||||||0.7236|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||0.7236
71132048|NCT00445770|141767274|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||<0.0001
71132049|NCT00445770|141767274|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||<0.0001
71132050|NCT00445770|141767274|SUPERIORITY_OR_OTHER|||||||0.9719|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||0.9719
71132051|NCT00445770|141767274|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||<0.0001
71132052|NCT00445770|141767274|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||<0.0001
71132053|NCT00445770|141767274|SUPERIORITY_OR_OTHER|||||||0.9349|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||0.9349
71132054|NCT00445770|141767274|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||<0.0001
71132055|NCT00445770|141767274|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||0.0002
71132056|NCT00445770|141767274|SUPERIORITY_OR_OTHER|||||||0.7226|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||0.7226
71132057|NCT00445770|141767274|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||<0.0001
71132058|NCT00445770|141767274|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||<0.0001
71132059|NCT00445770|141767274|SUPERIORITY_OR_OTHER|||||||0.5512|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||0.5512
71132060|NCT00445770|141767275|SUPERIORITY_OR_OTHER|||||||0.0162|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||0.0162
71132061|NCT00445770|141767275|SUPERIORITY_OR_OTHER|||||||0.0035|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||0.0035
71132062|NCT00445770|141767275|SUPERIORITY_OR_OTHER|||||||0.8928|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||0.8928
71132063|NCT00445770|141767275|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||0.0009
71132064|NCT00445770|141767275|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||0.0007
71132065|NCT00445770|141767275|SUPERIORITY_OR_OTHER|||||||0.6348|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||0.6348
71132066|NCT00445770|141767275|SUPERIORITY_OR_OTHER|||||||0.0026|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||0.0026
71132067|NCT00445770|141767275|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||<0.0001
71132068|NCT00445770|141767275|SUPERIORITY_OR_OTHER|||||||0.4629|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||0.4629
71132069|NCT00445770|141767275|SUPERIORITY_OR_OTHER|||||||0.0841|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||0.0841
71132070|NCT00445770|141767275|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||0.0007
71132071|NCT00445770|141767275|SUPERIORITY_OR_OTHER|||||||0.1957|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||0.1957
71132072|NCT00445770|141767275|SUPERIORITY_OR_OTHER|||||||0.0093|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||0.0093
71132073|NCT00445770|141767275|SUPERIORITY_OR_OTHER|||||||0.0326|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||0.0326
71132074|NCT00445770|141767275|SUPERIORITY_OR_OTHER|||||||0.7426|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||0.7426
71132075|NCT00445770|141767275|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.0013
71132076|NCT00445770|141767275|SUPERIORITY_OR_OTHER|||||||0.0015|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.0015
71132077|NCT00445770|141767275|SUPERIORITY_OR_OTHER|||||||0.6552|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.6552
71132078|NCT00445770|141767275|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||0.0005
71132079|NCT00445770|141767275|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||0.0004
71132080|NCT00445770|141767275|SUPERIORITY_OR_OTHER|||||||0.6294|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||0.6294
71132081|NCT00445770|141767275|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||<0.0001
71132082|NCT00445770|141767275|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||0.0001
71132083|NCT00445770|141767275|SUPERIORITY_OR_OTHER|||||||0.4652|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||0.4652
71132084|NCT00445770|141767275|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||<0.0001
71132085|NCT00445770|141767275|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||0.0002
71132086|NCT00445770|141767275|SUPERIORITY_OR_OTHER|||||||0.2233|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||0.2233
71132087|NCT00445770|141767275|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||<0.0001
71132088|NCT00445770|141767275|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||0.0003
71132089|NCT00445770|141767275|SUPERIORITY_OR_OTHER|||||||0.6772|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||0.6772
71132090|NCT00445770|141767275|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||<0.0001
71132091|NCT00445770|141767275|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||<0.0001
71132092|NCT00445770|141767275|SUPERIORITY_OR_OTHER|||||||0.616|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||0.6160
71132093|NCT00445770|141767276|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2||||<0.0001
71132094|NCT00445770|141767276|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2||||<0.0001
71132095|NCT00445770|141767276|SUPERIORITY_OR_OTHER|||||||0.4929|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2||||0.4929
71132096|NCT00445770|141767276|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||<0.0001
71132097|NCT00445770|141767276|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||<0.0001
71132098|NCT00445770|141767276|SUPERIORITY_OR_OTHER|||||||0.9693|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||0.9693
71132099|NCT00445770|141767276|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||<0.0001
71132100|NCT00445770|141767276|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||<0.0001
71132101|NCT00445770|141767276|SUPERIORITY_OR_OTHER|||||||0.4139|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||0.4139
71132102|NCT00445770|141767276|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||<0.0001
71132103|NCT00445770|141767276|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||<0.0001
71132104|NCT00445770|141767276|SUPERIORITY_OR_OTHER|||||||0.8905|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||0.8905
71132105|NCT00445770|141767276|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||<0.0001
71132106|NCT00445770|141767276|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||<0.0001
71132107|NCT00445770|141767276|SUPERIORITY_OR_OTHER|||||||0.6877|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||0.6877
71132108|NCT00445770|141767276|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||<0.0001
71132109|NCT00445770|141767276|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||<0.0001
71132110|NCT00445770|141767276|SUPERIORITY_OR_OTHER|||||||0.4511|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||0.4511
71132111|NCT00445770|141767276|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||<0.0001
71132112|NCT00445770|141767276|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||<0.0001
71132113|NCT00445770|141767276|SUPERIORITY_OR_OTHER|||||||0.2786|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||0.2786
71132114|NCT00445770|141767276|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||<0.0001
71132115|NCT00445770|141767276|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||<0.0001
71132116|NCT00445770|141767276|SUPERIORITY_OR_OTHER|||||||0.123|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||0.1230
71132117|NCT00445770|141767276|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||<0.0001
71132118|NCT00445770|141767276|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||<0.0001
71132119|NCT00445770|141767276|SUPERIORITY_OR_OTHER|||||||0.5061|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||0.5061
71132120|NCT00445770|141767276|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||<0.0001
71132121|NCT00445770|141767276|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||<0.0001
71132122|NCT00445770|141767276|SUPERIORITY_OR_OTHER|||||||0.1354|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||0.1354
71132123|NCT00445770|141767276|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||<0.0001
71132124|NCT00445770|141767276|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||<0.0001
71132125|NCT00445770|141767276|SUPERIORITY_OR_OTHER|||||||0.1734|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||0.1734
71132126|NCT00445770|141767277|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
71132127|NCT00445770|141767277|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
70872065|NCT02155608|141229485|SUPERIORITY|||||||0.16||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 2.05, df = 1/50.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.16
70947287|NCT03845075|141395106|SUPERIORITY||LS Mean Difference|-17.33||||0.1529|TWO_SIDED|95.0|-41.87|7.2||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Like to eat something fatty).||7.20|-41.87|0.1529
71132128|NCT00445770|141767277|SUPERIORITY_OR_OTHER|||||||0.6417|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.6417
71132129|NCT00445770|141767277|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
71132130|NCT00445770|141767277|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
71132131|NCT00445770|141767277|SUPERIORITY_OR_OTHER|||||||0.4698|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.4698
71132132|NCT00445770|141767277|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
71132133|NCT00445770|141767277|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
71132134|NCT00445770|141767277|SUPERIORITY_OR_OTHER|||||||0.1214|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.1214
71132135|NCT00445770|141767277|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
71132136|NCT00445770|141767277|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
71132137|NCT00445770|141767277|SUPERIORITY_OR_OTHER|||||||0.4654|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.4654
71132138|NCT00445770|141767277|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
71132139|NCT00445770|141767277|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
71132140|NCT00445770|141767277|SUPERIORITY_OR_OTHER|||||||0.4006|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.4006
71132141|NCT00445770|141767277|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
70872066|NCT02155608|141229486|SUPERIORITY|||||||0.91||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .01, df = 1/56.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.91
70947288|NCT03845075|141395106|SUPERIORITY||LS Mean Difference|-11.75||||0.3399|TWO_SIDED|95.0|-37.15|13.65||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Like some meat/fish).||13.65|-37.15|0.3399
71132142|NCT00445770|141767277|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
71132143|NCT00445770|141767277|SUPERIORITY_OR_OTHER|||||||0.1636|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.1636
71132144|NCT00445770|141767277|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
71132145|NCT00445770|141767277|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
71132146|NCT00445770|141767277|SUPERIORITY_OR_OTHER|||||||0.2635|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.2635
71132147|NCT00445770|141767277|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
71132148|NCT00445770|141767277|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
71132149|NCT00445770|141767277|SUPERIORITY_OR_OTHER|||||||0.0965|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.0965
71132150|NCT00445770|141767277|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
71132151|NCT00445770|141767277|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
71132152|NCT00445770|141767277|SUPERIORITY_OR_OTHER|||||||0.4437|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.4437
71132153|NCT00445770|141767277|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
71132154|NCT00445770|141767277|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
71132155|NCT00445770|141767277|SUPERIORITY_OR_OTHER|||||||0.1663|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.1663
71132156|NCT00445770|141767277|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
71132157|NCT00445770|141767277|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
71132158|NCT00445770|141767277|SUPERIORITY_OR_OTHER|||||||0.1049|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.1049
71132159|NCT00445770|141767278|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment||Week 2||||<0.0001
70947289|NCT03845075|141395106|SUPERIORITY||LS Mean Difference|-23.95||||0.0673|TWO_SIDED|95.0|-49.84|1.93||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Eat something salty).||1.93|-49.84|0.0673
71132160|NCT00445770|141767278|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment||Week 2||||<0.0001
71132161|NCT00445770|141767278|SUPERIORITY_OR_OTHER|||||||0.0442|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment||Week 2||||0.0442
71132162|NCT00445770|141767278|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||<0.0001
71132163|NCT00445770|141767278|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||<0.0001
71132164|NCT00445770|141767278|SUPERIORITY_OR_OTHER|||||||0.0681|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||0.0681
71132165|NCT00445770|141767278|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||<0.0001
71132166|NCT00445770|141767278|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||<0.0001
71132167|NCT00445770|141767278|SUPERIORITY_OR_OTHER|||||||0.0966|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||0.0966
71132168|NCT00445770|141767278|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||<0.0001
71132169|NCT00445770|141767278|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||0.0006
71132170|NCT00445770|141767278|SUPERIORITY_OR_OTHER|||||||0.1242|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||0.1242
71132171|NCT00445770|141767278|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||<0.0001
70947290|NCT03845075|141395106|SUPERIORITY||LS Mean Difference|-22.6||||0.1657|TWO_SIDED|95.0|-55.65|10.46||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Eat something sweet).||10.46|-55.65|0.1657
70947291|NCT03845075|141395106|SUPERIORITY||LS Mean Difference|-30.18||||0.0108|TWO_SIDED|95.0|-52.31|-8.06||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Like to eat something fatty).||-8.06|-52.31|0.0108
71132172|NCT00445770|141767278|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||<0.001
71132173|NCT00445770|141767278|SUPERIORITY_OR_OTHER|||||||0.1521|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||0.1521
71132174|NCT00445770|141767278|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||<0.0001
71132175|NCT00445770|141767278|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||0.0070
71132176|NCT00445770|141767278|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||0.0140
71132177|NCT00445770|141767278|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||<0.0001
71132178|NCT00445770|141767278|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||<0.0001
71132179|NCT00445770|141767278|SUPERIORITY_OR_OTHER|||||||0.0815|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||0.0815
71132180|NCT00445770|141767278|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||<0.0001
71132181|NCT00445770|141767278|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||0.0002
71132182|NCT00445770|141767278|SUPERIORITY_OR_OTHER|||||||0.0886|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||0.0886
71132183|NCT00445770|141767278|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||<0.0001
71132184|NCT00445770|141767278|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||0.0003
71132185|NCT00445770|141767278|SUPERIORITY_OR_OTHER|||||||0.1488|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||0.1488
71132186|NCT00445770|141767278|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||<0.0001
71132187|NCT00445770|141767278|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||0.0006
71132188|NCT00445770|141767278|SUPERIORITY_OR_OTHER|||||||0.0979|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||0.0979
71132189|NCT00445770|141767278|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||<0.0001
71132190|NCT00445770|141767278|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||0.0001
71132191|NCT00445770|141767278|SUPERIORITY_OR_OTHER|||||||0.174|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||0.1740
71132192|NCT00445770|141767279|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior Methotrexate use + treatment.||Week 2||||<0.0001
71132193|NCT00445770|141767279|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 2||||<0.0001
71132194|NCT00445770|141767279|SUPERIORITY_OR_OTHER|||||||0.0274|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.|ANCOVA|||Week 2||||0.0274
71132195|NCT00445770|141767279|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 4||||<0.0001
71132196|NCT00445770|141767279|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 4||||<0.0001
71132197|NCT00445770|141767279|SUPERIORITY_OR_OTHER|||||||0.0344|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 4||||0.0344
71132198|NCT00445770|141767279|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 8||||<0.0001
71132199|NCT00445770|141767279|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 8||||<0.0001
71132200|NCT00445770|141767279|SUPERIORITY_OR_OTHER|||||||0.0293|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 8||||0.0293
71132201|NCT00445770|141767279|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 12||||<0.0001
71132202|NCT00445770|141767279|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 12||||<0.0001
71132203|NCT00445770|141767279|SUPERIORITY_OR_OTHER|||||||0.0452|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 12||||0.0452
71132204|NCT00445770|141767279|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 16||||<0.0001
71132205|NCT00445770|141767279|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 16||||<0.0001
71132206|NCT00445770|141767279|SUPERIORITY_OR_OTHER|||||||0.0313|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 16||||0.0313
71132207|NCT00445770|141767279|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 20||||<0.0001
71132208|NCT00445770|141767279|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 20||||0.0019
71132209|NCT00445770|141767279|SUPERIORITY_OR_OTHER|||||||0.0781|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 20||||0.0781
71132210|NCT00445770|141767279|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 24||||<0.0001
71132211|NCT00445770|141767279|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 24||||0.0001
71132212|NCT00445770|141767279|SUPERIORITY_OR_OTHER|||||||0.1279|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 24||||0.1279
71132213|NCT00445770|141767279|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 32||||<0.0001
71132214|NCT00445770|141767279|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 32||||0.0004
71132215|NCT00445770|141767279|SUPERIORITY_OR_OTHER|||||||0.0807|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 32||||0.0807
71132216|NCT00445770|141767279|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 40||||<0.0001
71132217|NCT00445770|141767279|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 40||||0.0002
71132218|NCT00445770|141767279|SUPERIORITY_OR_OTHER|||||||0.418|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 40||||0.4180
71132219|NCT00445770|141767279|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 48||||<0.0001
71132220|NCT00445770|141767279|SUPERIORITY_OR_OTHER|||||||0.0061|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 48||||0.0061
71132221|NCT00445770|141767279|SUPERIORITY_OR_OTHER|||||||0.1615|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 48||||0.1615
71132222|NCT00445770|141767279|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 52||||<0.0001
71132223|NCT00445770|141767279|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 52||||0.0130
71132224|NCT00445770|141767279|SUPERIORITY_OR_OTHER|||||||0.0948|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 52||||0.0948
71132225|NCT03857542|141767281|SUPERIORITY||Percentage Difference|15.2|||<|0.0001|TWO_SIDED|95.0|7.7|22.7||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. The 95% confidence intervals for the proportion differences were calculated based on the normal approximation based on pooled variance without continuity correction.|||22.7|7.7|<.0001
71132226|NCT03857542|141767282|SUPERIORITY||Percentage Difference|6.5||||0.0548|TWO_SIDED|95.0|-0.1|13.1||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. The 95% confidence intervals for the proportion difference was calculated based on the normal approximation based on pooled variance without continuity correction.|||13.1|-0.1|0.0548
71132227|NCT03857542|141767283|SUPERIORITY||Percentage Difference|5.9||||0.0693|TWO_SIDED|95.0|-0.5|12.2||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. The 95% confidence intervals for the proportion difference was calculated based on the normal approximation based on pooled variance without continuity correction.|||12.2|-0.5|0.0693
71132228|NCT03857542|141767284|SUPERIORITY||Least Squares (LS) Mean Difference|4.1|STANDARD_ERROR_OF_MEAN|0.59|<|0.0001|TWO_SIDED|95.0|2.9|5.2||MMRM with study intervention group, visit, visit by study intervention group interaction, age group, Baseline binocular DCNVA severity, iris color, emmetrope/non-emmetrope, Baseline value; Baseline value by visit interaction as fixed effects.|MMRM|P-value was adjusted for multiplicity control.||||5.2|2.9|<.0001
71132229|NCT03857542|141767285|SUPERIORITY||Percentage Difference|9.9||||0.0141|TWO_SIDED|95.0|3.5|16.3||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using chi-square test. The 95% confidence intervals was calculated based on normal approximation based on pooled variance without continuity correction.|||16.3|3.5|0.0141
71132230|NCT03857542|141767286|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|0.5|1.0||Analysis of covariance (ANCOVA) with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control||||1.0|0.5|<.0001
71132231|NCT03857542|141767287|SUPERIORITY||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|0.52|<|0.0001|TWO_SIDED|95.0|2.4|4.4||MMRM with study intervention group, visit, visit by study intervention group interaction, age group, Baseline binocular DCNVA severity, iris color, emmetrope/non-emmetrope, Baseline value, and Baseline value by visit interaction as fixed effects.|MMRM|P-value was adjusted for multiplicity control.||||4.4|2.4|<.0001
71132232|NCT03857542|141767288|SUPERIORITY||Percentage Difference|3.8||||0.22|TWO_SIDED|95.0|-2.3|10.0||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using chi-square test. The 95% confidence intervals for the proportion differences were calculated based on the normal approximation based on pooled variance without continuity correction.|||10.0|-2.3|0.2200
71132233|NCT03857542|141767289|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|1.5|3.7||MMRM with study intervention group, visit, visit by study intervention group interaction, age group, Baseline binocular DCNVA severity, iris color, emmetrope/non-emmetrope, Baseline value, and Baseline value by visit interaction as fixed effects.|MMRM|P-value was adjusted for multiplicity control.||||3.7|1.5|<.0001
71132234|NCT03857542|141767290|SUPERIORITY||Percentage Difference|12.4||||0.0141|TWO_SIDED|95.0|5.2|19.5||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using chi-square test. The 95% confidence intervals was calculated based on normal approximation based on pooled variance without continuity correction.|||19.5|5.2|0.0141
71132235|NCT03857542|141767291|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|0.5|1.0||ANCOVA with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||1.0|0.5|<.0001
71132236|NCT03857542|141767292|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.08||0.0002|TWO_SIDED|95.0|-0.5|-0.2||ANCOVA with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||-0.2|-0.5|0.0002
70947292|NCT03845075|141395106|SUPERIORITY||LS Mean Difference|-14.79||||0.171|TWO_SIDED|95.0|-36.71|7.13||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Like some meat/fish).||7.13|-36.71|0.1710
71132237|NCT03857542|141767293|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.07||0.0002|TWO_SIDED|95.0|-0.4|-0.2||ANCOVA with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||-0.2|-0.4|0.0002
71132238|NCT04255862|141767308|EQUIVALENCE|Bioequivalence (BE) was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 80 to 125 for AUC.|Geometric Mean Ratio|103.4|||||TWO_SIDED|90.0|86.4|123.8||||||||123.8|86.4|
71132239|NCT04255862|141767308|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 80 to 125 for AUC.|Geometric Mean Ratio|115.0|||||TWO_SIDED|90.0|97.9|135.0||||||||135.0|97.9|
70947293|NCT03845075|141395106|SUPERIORITY||LS Mean Difference|-19.86||||0.0083|TWO_SIDED|95.0|-33.8|-5.93||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Eat something salty).||-5.93|-33.80|0.0083
70947294|NCT03845075|141395106|SUPERIORITY||LS Mean Difference|-22.98||||0.0631|TWO_SIDED|95.0|-47.39|1.43||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Eat something sweet).||1.43|-47.39|0.0631
71132240|NCT04255862|141767309|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 80 to 125 for AUC0-t.|Geometric Mean Ratio|102.8|||||TWO_SIDED|90.0|87.0|121.5||||||||121.5|87.0|
71132241|NCT04255862|141767309|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 80 to 125 for AUC0-t.|Geometric Mean Ratio|113.4|||||TWO_SIDED|90.0|97.4|131.9||||||||131.9|97.4|
71132242|NCT04255862|141767310|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 80 to 125 for Cmax.|Geometric Mean Ratio|104.0|||||TWO_SIDED|90.0|90.3|119.7||||||||119.7|90.3|
70947295|NCT03845075|141395107|SUPERIORITY||LS Mean Difference|-2.56||||0.8082|TWO_SIDED|95.0|-24.65|19.53||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 24; mITT observed.||19.53|-24.65|0.8082
70947296|NCT03845075|141395107|SUPERIORITY||LS Mean Difference|-1.42||||0.9034|TWO_SIDED|95.0|-25.94|23.1||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF.||23.10|-25.94|0.9034
71132243|NCT04255862|141767310|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 80 to 125 for Cmax.|Geometric Mean Ratio|114.3|||||TWO_SIDED|90.0|99.5|131.4||||||||131.4|99.5|
71132244|NCT02610777|141767338|SUPERIORITY||Hazard Ratio (HR)|0.861||||0.464|TWO_SIDED|95.0|0.577|1.286||P-value is from an unstratified log-rank test.|Log Rank||Hazard Ratio (HR) was based on an unstratified Cox proportional hazard regression model with treatment as a factor.|||1.286|0.577|0.464
71132245|NCT02610777|141767339|SUPERIORITY||Hazard Ratio (HR)|0.706|||=|0.092|TWO_SIDED|95.0|0.469|1.061||P-value comparing EFS between treatment groups was based on the unstratified log-rank test.|Log Rank||HR:unadjusted stratified Cox proportional hazard regression with stratification(low-blast AML,IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1:better prevention of EFS in combination arm than azacitidine arm.|Event-Free Survival (EFS)||1.061|0.469|=0.092
70860341|NCT01227564|141206990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.7281|TWO_SIDED|95.0|-0.49|0.69||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.69|-0.49|0.7281
70860342|NCT01227564|141206990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.3347|TWO_SIDED|95.0|-0.26|0.75||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.75|-0.26|0.3347
70860343|NCT01227564|141206990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.3425|TWO_SIDED|95.0|-0.43|1.2||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||1.20|-0.43|0.3425
70860344|NCT01227564|141206990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.4501|TWO_SIDED|95.0|-1.16|0.52||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.52|-1.16|0.4501
70860345|NCT01227564|141206990|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.04||||0.9227|TWO_SIDED|95.0|-0.68|0.75||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.75|-0.68|0.9227
70860346|NCT01227564|141206990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.345|TWO_SIDED|95.0|-0.51|1.45||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.45|-0.51|0.3450
70860347|NCT01227564|141206990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.274|TWO_SIDED|95.0|-1.58|0.45||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.45|-1.58|0.2740
70860348|NCT01227564|141206990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.914|TWO_SIDED|95.0|-0.92|0.82||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.82|-0.92|0.9140
70860349|NCT01227564|141206990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03||||0.0923|TWO_SIDED|95.0|-0.18|2.24||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.24|-0.18|0.0923
70860350|NCT01227564|141206990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.8482|TWO_SIDED|95.0|-1.11|1.35||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||1.35|-1.11|0.8482
71132246|NCT02610777|141767342|SUPERIORITY||Hazard Ratio (HR)|0.562|||=|0.267|TWO_SIDED|95.0|0.2|1.579||P-value is from an unstratified log-rank test.|Log Rank||Hazard ratio (HR) is based on an unstratified Cox proportional hazard regression model with treatment as a factor.|||1.579|0.200|=0.267
71132247|NCT02610777|141767343|SUPERIORITY||Absolute Rate Difference|9.61|||=|0.312|TWO_SIDED|95.0|-8.83|28.04||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||28.04|-8.83|=0.312
71132248|NCT02610777|141767344|SUPERIORITY||Absolute Rate Difference|5.63||||0.56|TWO_SIDED|95.0|-13.19|24.44||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||24.44|-13.19|0.560
71132249|NCT02610777|141767345|SUPERIORITY||Absolute Rate Difference|8.64|||=|0.343|TWO_SIDED|95.0|-9.09|26.38||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||26.38|-9.09|=0.343
71132250|NCT02610777|141767346|SUPERIORITY||Absolute Rate Difference|-18.82|||=|0.296|TWO_SIDED|95.0|-52.91|15.26||P-value is from an unstratified Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||15.26|-52.91|=0.296
71132251|NCT02610777|141767347|SUPERIORITY||Absolute Rate Difference|13.16|||=|0.152|TWO_SIDED|95.0|-4.49|30.81||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||30.81|-4.49|=0.152
71132252|NCT02610777|141767348|SUPERIORITY||Absolute Rate Difference|10.53|||=|0.301|TWO_SIDED|95.0|-9.13|30.18||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||30.18|-9.13|=0.301
71132253|NCT02610777|141767349|SUPERIORITY||Absolute Rate Difference|13.16|||=|0.254|TWO_SIDED|95.0|-9.12|35.44||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||35.44|-9.12|=0.254
71132254|NCT02610777|141767350|SUPERIORITY||Absolute Rate Difference|-4.71|||=|0.787|TWO_SIDED|95.0|-38.33|28.92||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||28.92|-38.33|=0.787
71132255|NCT02610777|141767351|SUPERIORITY||Hazard Ratio (HR)|0.789|||=|0.62|TWO_SIDED|95.0|0.308|2.02||P-value is from an unstratified log-rank test.|Log Rank||Hazard ratio was based on an unstratified Cox proportional hazard regression model and treatment as a factor in the model.|||2.020|0.308|=0.620
71132256|NCT02610777|141767352|SUPERIORITY||Hazard Ratio (HR)|0.719|||=|0.436|TWO_SIDED|95.0|0.313|1.653||P-value is from an unstratified log-rank test.|Log Rank||Hazard ratio was based on an unstratified Cox proportional hazard regression model and treatment as a factor in the model.|||1.653|0.313|=0.436
71132257|NCT02610777|141767353|SUPERIORITY||Hazard Ratio (HR)|0.81|||=|0.565|TWO_SIDED|95.0|0.395|1.662||P-value is from an unstratified log-rank test.|Log Rank||Hazard ratio was based on an unstratified Cox proportional hazard regression model and treatment as a factor in the model.|||1.662|0.395|=0.565
71132258|NCT02610777|141767354|SUPERIORITY||Hazard Ratio (HR)|0.42|||=|0.383|TWO_SIDED|95.0|0.057|3.109||P-value comparing duration of CR in low blast AML between treatment groups is based on unstratified log-rank test.|Log Rank||Hazard ratio was based on an unstratified Cox proportional hazard regression model and treatment as a factor in the model.|||3.109|0.057|=0.383
71132259|NCT02610777|141767355|SUPERIORITY||Hazard Ratio (HR)|1.206|||=|0.498|TWO_SIDED|95.0|0.699|2.081||P-value is from an unstratified log-rank test.|Log Rank||HR is based on an unstratified Cox proportional hazard regression model with treatment as a factor. HR\>1 for the treatment indicates a shorter time to first CR, CRi or PR in the Pevonedistat Combination arm compared to the Azacitidine only arm.|||2.081|0.699|=0.498
71132260|NCT02610777|141767356|SUPERIORITY||Hazard Ratio (HR)|0.905|||=|0.888|TWO_SIDED|95.0|0.226|3.62||P-value is from an unstratified log-rank test.|Log Rank||HR is based on an unstratified Cox proportional hazard regression model with treatment as a factor. HR\<1for the treatment indicates a longer time to Subsequent Therapy in the Pevonedistat Combination arm compared to the Azacitidine only arm.|||3.620|0.226|=0.888
71132261|NCT02610777|141767357|SUPERIORITY||Absolute Rate Difference|19.231|||=|0.162|TWO_SIDED|95.0|-6.925|45.386||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel|||Percentage of Participants With RBCs-transfusion Independence||45.386|-6.925|=0.162
71132262|NCT02610777|141767357|SUPERIORITY||Absolute Rate Difference|20.0|||=|0.454|TWO_SIDED|95.0|-26.381|66.381||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel|||Percentage of Participants With Platelet-transfusion Independence||66.381|-26.381|=0.454
71132263|NCT02610777|141767359|SUPERIORITY||Hazard Ratio (HR)|0.79|||=|0.266|TWO_SIDED|95.0|0.521|1.198||P-value is from an unstratified log-rank test.|Log Rank||HR is based on an unstratified Cox proportional hazard regression model with treatment as a factor. HR\<1for the treatment indicates a longer time to PD, Relapse, or Death in the Pevonedistat Combination arm compared to the Azacitidine only arm.|||1.198|0.521|=0.266
71132264|NCT01724866|141767365|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.72||||0.296|TWO_SIDED|95.0|0.19|1.27|||Bootstrap method|||A 2-sided 95% confidence interval (CI) for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||1.27|0.19|0.296
71132265|NCT01724866|141767365|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.14||||0.002|TWO_SIDED|95.0|-0.28|0.64|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.64|-0.28|0.002
70860351|NCT01227564|141206990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57||||0.284|TWO_SIDED|95.0|-0.49|1.64||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||1.64|-0.49|0.2840
70860352|NCT01227564|141206991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99||||0.1767|TWO_SIDED|95.0|-4.9|0.92||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.92|-4.90|0.1767
70860353|NCT01227564|141206991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.26||||0.0057|TWO_SIDED|95.0|-7.23|-1.29||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||-1.29|-7.23|0.0057
70860354|NCT01227564|141206991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.13||||0.0176|TWO_SIDED|95.0|-5.69|-0.57||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||-0.57|-5.69|0.0176
70860355|NCT01227564|141206991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.679|TWO_SIDED|95.0|-3.98|2.61||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||2.61|-3.98|0.6790
70860356|NCT01227564|141206991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.9028|TWO_SIDED|95.0|-3.62|3.2||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||3.20|-3.62|0.9028
70860357|NCT01227564|141206991|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.45||||0.76|TWO_SIDED|95.0|-3.36|2.47||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||2.47|-3.36|0.7600
70860358|NCT01227564|141206991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32||||0.4089|TWO_SIDED|95.0|-4.51|1.86||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.86|-4.51|0.4089
70872067|NCT02155608|141229486|SUPERIORITY|||||||0.15||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 2.12, df = .15||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.15
70947297|NCT03845075|141395107|SUPERIORITY||LS Mean Difference|-7.0||||0.4658|TWO_SIDED|95.0|-26.93|12.93||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF.||12.93|-26.93|0.4658
70947298|NCT03845075|141395108|SUPERIORITY||LS Mean Difference|-5.68||||0.0537|TWO_SIDED|95.0|-11.46|0.1||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 24; mITT LOCF.||0.10|-11.46|0.0537
70947299|NCT03845075|141395108|SUPERIORITY||LS Mean Difference|-2.69||||0.3772|TWO_SIDED|95.0|-8.98|3.61||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF.||3.61|-8.98|0.3772
70947300|NCT03845075|141395108|SUPERIORITY||LS Mean Difference|3.03||||0.1171|TWO_SIDED|95.0|-0.85|6.91||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF.||6.91|-0.85|0.1171
71132266|NCT01724866|141767365|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|-0.28|||<|0.001|TWO_SIDED|95.0|-0.56|-0.06|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-values was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||-0.06|-0.56|<0.001
71132267|NCT01724866|141767366|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.38||||0.001|TWO_SIDED|95.0|0.06|0.74|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.74|0.06|0.001
71132268|NCT01724866|141767366|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.04|||<|0.001|TWO_SIDED|95.0|-0.16|0.24|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.24|-0.16|<0.001
71132269|NCT01724866|141767366|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|-0.05|||<|0.001|TWO_SIDED|95.0|-0.19|0.06|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.06|-0.19|<0.001
71132270|NCT01724866|141767367|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.31||||0.002|TWO_SIDED|95.0|-0.07|0.72|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.72|-0.07|0.002
71132271|NCT01724866|141767367|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.02|||<|0.001|TWO_SIDED|95.0|-0.27|0.3|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.30|-0.27|<0.001
71132272|NCT01724866|141767367|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.01|||<|0.001|TWO_SIDED|95.0|-0.27|0.28|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.28|-0.27|<0.001
71132273|NCT01724866|141767368|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.94||||0.781|TWO_SIDED|95.0|-0.01|2.47|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||2.47|-0.01|0.781
71132274|NCT01724866|141767368|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.07|||<|0.001|TWO_SIDED|95.0|-0.17|0.38|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.38|-0.17|<0.001
71132275|NCT01724866|141767368|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|-0.02|||<|0.001|TWO_SIDED|95.0|-0.23|0.22|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.22|-0.23|<0.001
71132276|NCT01724866|141767369|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.002|TWO_SIDED|95.0|1.1|1.8|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.8|1.1|0.002
71132277|NCT01724866|141767369|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.711|TWO_SIDED|95.0|0.6|1.4|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.4|0.6|0.711
71132278|NCT01724866|141767369|SUPERIORITY||Hazard Ratio (HR)|0.3||||0.028|TWO_SIDED|95.0|0.1|0.9|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||0.9|0.1|0.028
71132279|NCT01724866|141767370|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.672|TWO_SIDED|95.0|0.8|1.4|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.4|0.8|0.672
71132280|NCT01724866|141767370|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.348|TWO_SIDED|95.0|0.5|1.3|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.3|0.5|0.348
71132281|NCT01724866|141767370|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.973|TWO_SIDED|95.0|0.4|2.9|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||2.9|0.4|0.973
71132282|NCT01724866|141767371|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.618|TWO_SIDED|95.0|0.8|1.4|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.4|0.8|0.618
71132283|NCT01724866|141767371|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.661|TWO_SIDED|95.0|0.5|1.6|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.6|0.5|0.661
70860359|NCT01227564|141206991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.17||||0.1964|TWO_SIDED|95.0|-5.49|1.15||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.15|-5.49|0.1964
70860360|NCT01227564|141206991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75||||0.2234|TWO_SIDED|95.0|-4.58|1.09||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.09|-4.58|0.2234
70860361|NCT01227564|141206991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.6186|TWO_SIDED|95.0|-3.52|2.12||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.12|-3.52|0.6186
70860362|NCT01227564|141206991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77||||0.5853|TWO_SIDED|95.0|-3.6|2.06||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.06|-3.60|0.5853
70860363|NCT01227564|141206991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74||||0.5541|TWO_SIDED|95.0|-3.23|1.75||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||1.75|-3.23|0.5541
70860364|NCT01227564|141206992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.937|TWO_SIDED|95.0|-2.09|1.93||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||1.93|-2.09|0.9370
70860365|NCT01227564|141206992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16||||0.2597|TWO_SIDED|95.0|-3.19|0.88||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.88|-3.19|0.2597
70860366|NCT01227564|141206992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.4852|TWO_SIDED|95.0|-2.38|1.14||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||1.14|-2.38|0.4852
70860367|NCT01227564|141206992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73||||0.4542|TWO_SIDED|95.0|-2.69|1.22||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||1.22|-2.69|0.4542
70860368|NCT01227564|141206992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.3061|TWO_SIDED|95.0|-3.04|0.97||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.97|-3.04|0.3061
70860369|NCT01227564|141206992|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.88||||0.3082|TWO_SIDED|95.0|-2.61|0.84||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.84|-2.61|0.3082
70860370|NCT01227564|141206992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.2672|TWO_SIDED|95.0|-3.09|0.87||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.87|-3.09|0.2672
70860371|NCT01227564|141206992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.11||||0.0427|TWO_SIDED|95.0|-4.15|-0.07||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||-0.07|-4.15|0.0427
70860372|NCT01227564|141206992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.61||||0.0716|TWO_SIDED|95.0|-3.37|0.15||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.15|-3.37|0.0716
70872068|NCT02155608|141229486|SUPERIORITY|||||||0.64||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .21, df = 1/56.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.64
70872069|NCT02155608|141229486|SUPERIORITY|||||||0.66||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .20, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.66
70947301|NCT03845075|141395109|SUPERIORITY||LS Mean Difference|-0.05||||0.8623|TWO_SIDED|95.0|-0.59|0.5||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 24; mITT observed. (Change in total cholesterol)||0.50|-0.59|0.8623
70947302|NCT03845075|141395109|SUPERIORITY||LS Mean Difference|0.03||||0.8327|TWO_SIDED|95.0|-0.25|0.3||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 24; mITT observed. (Change in HDL cholesterol)||0.30|-0.25|0.8327
70947303|NCT03845075|141395109|SUPERIORITY||LS Mean Difference|-0.06||||0.808|TWO_SIDED|95.0|-0.53|0.42||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 24; mITT observed. (Change in LDL cholesterol)||0.42|-0.53|0.8080
71132284|NCT01724866|141767371|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.754|TWO_SIDED|95.0|0.3|2.8|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||2.8|0.3|0.754
71132285|NCT01724866|141767372|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.009|TWO_SIDED|95.0|1.1|1.7|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.7|1.1|0.009
71132286|NCT01724866|141767372|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.527|TWO_SIDED|95.0|0.7|1.8|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.8|0.7|0.527
71132287|NCT01724866|141767372|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.815|TWO_SIDED|95.0|0.4|3.9|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||3.9|0.4|0.815
71132288|NCT01724866|141767373|SUPERIORITY|||||||0.008|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.008
71132289|NCT01724866|141767373|SUPERIORITY|||||||0.911|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.911
71132290|NCT01724866|141767373|SUPERIORITY|||||||0.002|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.002
71132291|NCT01724866|141767374|SUPERIORITY|||||||0.005|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.005
71132292|NCT01724866|141767374|SUPERIORITY|||||||0.633|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.633
71132293|NCT01724866|141767374|SUPERIORITY|||||||0.027|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.027
71132294|NCT01724866|141767375|SUPERIORITY|||||||0.015|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.015
70947304|NCT03845075|141395109|SUPERIORITY||LS Mean Difference|0.22||||0.5791|TWO_SIDED|95.0|-0.62|1.07|||ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 24; mITT observed. (Change in triglycerides)||1.07|-0.62|0.5791
70947305|NCT03845075|141395109|SUPERIORITY||LS Mean Difference|0.03||||0.9337|TWO_SIDED|95.0|-0.71|0.77||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Change in cholesterol)||0.77|-0.71|0.9337
70947306|NCT03845075|141395109|SUPERIORITY||LS Mean Difference|0.01||||0.9305|TWO_SIDED|95.0|-0.21|0.23||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Change in HDL cholesterol)||0.23|-0.21|0.9305
70947307|NCT03845075|141395109|SUPERIORITY||LS Mean Difference|0.09||||0.691|TWO_SIDED|95.0|-0.4|0.59||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Change in LDL cholesterol)||0.59|-0.40|0.6910
70947308|NCT03845075|141395109|SUPERIORITY||LS Mean Difference|0.35||||0.2688|TWO_SIDED|95.0|-0.3|1.01||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Change in triglycerides)||1.01|-0.30|0.2688
70947309|NCT03845075|141395109|SUPERIORITY||LS Mean Difference|0.06||||0.8262|TWO_SIDED|95.0|-0.54|0.67||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Change in cholesterol)||0.67|-0.54|0.8262
70947310|NCT03845075|141395109|SUPERIORITY||LS Mean Difference|-0.02||||0.8293|TWO_SIDED|95.0|-0.2|0.17||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Change in HDL cholesterol)||0.17|-0.20|0.8293
70872070|NCT02155608|141229486|SUPERIORITY|||||||0.48||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = .50, df = 1/47.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.48
70947311|NCT03845075|141395109|SUPERIORITY||LS Mean Difference|0.11||||0.5486|TWO_SIDED|95.0|-0.27|0.49||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Change in LDL cholesterol)||0.49|-0.27|0.5486
70860373|NCT01227564|141206992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46||||0.7184|TWO_SIDED|95.0|-2.09|3.0||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||3.00|-2.09|0.7184
70860374|NCT01227564|141206992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49||||0.7004|TWO_SIDED|95.0|-2.06|3.03||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||3.03|-2.06|0.7004
70860375|NCT01227564|141206992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.6723|TWO_SIDED|95.0|-1.77|2.71||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.71|-1.77|0.6723
70860376|NCT01227564|141206993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.9535|TWO_SIDED|95.0|-1.58|1.68||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||1.68|-1.58|0.9535
70860377|NCT01227564|141206993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9914|TWO_SIDED|95.0|-1.63|1.65||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||1.65|-1.63|0.9914
70860378|NCT01227564|141206993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.9682|TWO_SIDED|95.0|-1.39|1.44||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||1.44|-1.39|0.9682
70860379|NCT01227564|141206993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16||||0.2008|TWO_SIDED|95.0|-2.96|0.64||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.64|-2.96|0.2008
70860380|NCT01227564|141206993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.7988|TWO_SIDED|95.0|-2.07|1.6||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||1.60|-2.07|0.7988
70860381|NCT01227564|141206993|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.7||||0.3764|TWO_SIDED|95.0|-2.27|0.87||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.87|-2.27|0.3764
70860382|NCT01227564|141206993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86||||0.4177|TWO_SIDED|95.0|-2.98|1.25||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.25|-2.98|0.4177
70860383|NCT01227564|141206993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.6494|TWO_SIDED|95.0|-2.67|1.68||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.68|-2.67|0.6494
70860384|NCT01227564|141206993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.4674|TWO_SIDED|95.0|-2.54|1.18||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.18|-2.54|0.4674
70860385|NCT01227564|141206993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02||||0.4709|TWO_SIDED|95.0|-3.85|1.81||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||1.81|-3.85|0.4709
70860386|NCT01227564|141206993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.19||||0.4128|TWO_SIDED|95.0|-1.7|4.07||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||4.07|-1.70|0.4128
70860387|NCT01227564|141206993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.9478|TWO_SIDED|95.0|-2.41|2.58||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.58|-2.41|0.9478
70872071|NCT02155608|141229486|SUPERIORITY|||||||0.81||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .06, df = 1/47.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.81
70947312|NCT03845075|141395109|SUPERIORITY||LS Mean Difference|0.24||||0.3226|TWO_SIDED|95.0|-0.26|0.75||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Change in triglycerides)||0.75|-0.26|0.3226
71132295|NCT01724866|141767375|SUPERIORITY|||||||0.571|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.571
71132296|NCT01724866|141767375|SUPERIORITY|||||||0.066|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.066
71132297|NCT01724866|141767376|SUPERIORITY|||||||0.106|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.106
71132298|NCT01724866|141767376|SUPERIORITY|||||||0.156|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.156
71132299|NCT01724866|141767376|SUPERIORITY|||||||0.005|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.005
71132300|NCT01724866|141767377|SUPERIORITY||Ratio|0.4|||||TWO_SIDED|95.0|0.25|0.8||||||||0.80|0.25|
71132301|NCT01724866|141767377|SUPERIORITY||Ratio|1.0|||||TWO_SIDED|95.0|0.53|2.04||||||||2.04|0.53|
71132302|NCT01724866|141767377|SUPERIORITY||Ratio|2.5|||||TWO_SIDED|95.0|1.4|4.54||||||||4.54|1.40|
71132303|NCT01724866|141767378|SUPERIORITY||Ratio|0.5|||||TWO_SIDED|95.0|0.3|0.8||||||||0.80|0.30|
71132304|NCT01724866|141767378|SUPERIORITY||Ratio|1.1|||||TWO_SIDED|95.0|0.7|1.79||||||||1.79|0.70|
71132305|NCT01724866|141767378|SUPERIORITY||Ratio|1.7|||||TWO_SIDED|95.0|1.07|2.79||||||||2.79|1.07|
71132306|NCT01724866|141767379|SUPERIORITY||Ratio|0.5|||||TWO_SIDED|95.0|0.34|0.89||||||||0.89|0.34|
71132307|NCT01724866|141767379|SUPERIORITY||Ratio|1.1|||||TWO_SIDED|95.0|0.71|1.85||||||||1.85|0.71|
71132308|NCT01724866|141767379|SUPERIORITY||Ratio|1.6|||||TWO_SIDED|95.0|0.97|2.49||||||||2.49|0.97|
71132309|NCT01724866|141767380|SUPERIORITY||Ratio|0.7|||||TWO_SIDED|95.0|0.4|1.1||||||||1.10|0.40|
71132310|NCT01724866|141767380|SUPERIORITY||Ratio|1.4|||||TWO_SIDED|95.0|0.87|2.38||||||||2.38|0.87|
71132311|NCT01724866|141767380|SUPERIORITY||Ratio|1.9|||||TWO_SIDED|95.0|1.23|2.96||||||||2.96|1.23|
71132312|NCT01724866|141767385|SUPERIORITY||Percent Difference|2.1||||1|TWO_SIDED|95.0|-20.2|24.9|||Fisher Exact|||||24.9|-20.2|1.000
71132313|NCT01724866|141767385|SUPERIORITY||Percent Difference|-2.8||||1|TWO_SIDED|95.0|-26.7|21.4|||Fisher Exact|||||21.4|-26.7|1.000
71132314|NCT01724866|141767385|SUPERIORITY||Percent Difference|-2.8||||1|TWO_SIDED|95.0|-26.7|21.4|||Fisher Exact|||||21.4|-26.7|1.000
70947313|NCT03845075|141395110|SUPERIORITY||LS Mean Difference|0.59||||0.842|TWO_SIDED|95.0|-5.55|6.73||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; mITT LOCF. (Physical component score)||6.73|-5.55|0.8420
70947314|NCT03845075|141395110|SUPERIORITY||LS Mean Difference|-1.74||||0.6693|TWO_SIDED|95.0|-10.15|6.67||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; mITT LOCF. (Mental component score)||6.67|-10.15|0.6693
70872072|NCT02155608|141229487|SUPERIORITY|||||||0.89||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .02, df = 1/55.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.89
70947315|NCT03845075|141395110|SUPERIORITY||LS Mean Difference|-1.83||||0.5444|TWO_SIDED|95.0|-8.12|4.46||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 48; mITT LOCF. (Physical component score)||4.46|-8.12|0.5444
70872073|NCT02155608|141229487|SUPERIORITY|||||||0.14||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 2.28, df = 1/55.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.14
70872074|NCT02155608|141229487|SUPERIORITY|||||||0.8||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .06, df = .81.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.80
70947316|NCT03845075|141395110|SUPERIORITY||LS Mean Difference|-1.85||||0.5595|TWO_SIDED|95.0|-8.47|4.76||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 48; mITT LOCF. (Mental component score)||4.76|-8.47|0.5595
70947317|NCT03845075|141395110|SUPERIORITY||LS Mean Difference|-2.07||||0.4331|TWO_SIDED|95.0|-7.54|3.41||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Physical component score)||3.41|-7.54|0.4331
70947318|NCT03845075|141395110|SUPERIORITY||LS Mean Difference|-1.44||||0.6427|TWO_SIDED|95.0|-7.9|5.03||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Mental component score)||5.03|-7.90|0.6427
70947319|NCT03845075|141395112|SUPERIORITY||LS Mean Difference|5.86||||0.3037|TWO_SIDED|95.0|-5.76|17.48||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; safety set LOCF. (Change in systolic blood pressure)||17.48|-5.76|0.3037
70947320|NCT03845075|141395112|SUPERIORITY||LS Mean Difference|1.15||||0.7912|TWO_SIDED|95.0|-7.85|10.16||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; safety set LOCF. (Change in diastolic blood pressure)||10.16|-7.85|0.7912
70947321|NCT03845075|141395112|SUPERIORITY||LS Mean Difference|10.29||||0.1773|TWO_SIDED|95.0|-5.25|25.83||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 48; safety set LOCF. (Change in systolic blood pressure)||25.83|-5.25|0.1773
70872075|NCT02155608|141229487|SUPERIORITY|||||||0.93||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .01, df = 1/58.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.93
70872076|NCT02155608|141229487|SUPERIORITY|||||||0.15||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 2.22, df = 1/35.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.15
70947322|NCT03845075|141395112|SUPERIORITY||LS Mean Difference|1.32||||0.798|TWO_SIDED|95.0|-9.55|12.2||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 48; safety set LOCF. (Change in diastolic blood pressure)||12.20|-9.55|0.7980
70947323|NCT03845075|141395112|SUPERIORITY||LS Mean Difference|7.77||||0.158|TWO_SIDED|95.0|-3.4|18.94||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From week 24 to week 48; safety set LOCF. (Change in systolic blood pressure)||18.94|-3.40|0.1580
70872077|NCT02155608|141229487|SUPERIORITY|||||||0.28||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 1.23, df = 1/35.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.28
70947324|NCT03845075|141395112|SUPERIORITY||LS Mean Difference|1.64||||0.7021|TWO_SIDED|95.0|-7.36|10.64||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From week 24 to week 48; safety set LOCF. (Change in diastolic blood pressure)||10.64|-7.36|0.7021
70947325|NCT03845075|141395113|SUPERIORITY||LS Mean Difference|1.5||||0.8728|TWO_SIDED|95.0|-18.17|21.18||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; mITT LOCF. (Change in systolic blood pressure mean)||21.18|-18.17|0.8728
70947326|NCT03845075|141395113|SUPERIORITY||LS Mean Difference|2.46||||0.5714|TWO_SIDED|95.0|-6.61|11.54||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; mITT LOCF. (Change in diastolic blood pressure mean)||11.54|-6.61|0.5714
70947327|NCT03845075|141395113|SUPERIORITY||LS Mean Difference|-10.15||||0.2322|TWO_SIDED|95.0|-27.51|7.22||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 12; mITT LOCF. (Change in systolic blood pressure mean)||7.22|-27.51|0.2322
70947328|NCT03845075|141395113|SUPERIORITY||LS Mean Difference|-3.46||||0.4321|TWO_SIDED|95.0|-12.61|5.68||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 12; mITT LOCF. (Change in diastolic blood pressure mean)||5.68|-12.61|0.4321
70947329|NCT03845075|141395116|SUPERIORITY||LS Mean Difference|2.7||||0.5551|TWO_SIDED|95.0|-6.72|12.12||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; safety set LOCF. (Change in heart rate)||12.12|-6.72|0.5551
70947330|NCT03845075|141395116|SUPERIORITY||LS Mean Difference|-2.13||||0.7256|TWO_SIDED|95.0|-14.88|10.63||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 48; safety set LOCF. (Change in heart rate)||10.63|-14.88|0.7256
70947331|NCT03845075|141395116|SUPERIORITY||LS Mean Difference|-3.29||||0.4822|TWO_SIDED|95.0|-13.05|6.48||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From week 24 to week 48; safety set LOCF. (Change in heart rate)||6.48|-13.05|0.4822
70947332|NCT00935259|141395117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4|STANDARD_DEVIATION|52.1||0.455||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||||||0.455
70947333|NCT00935259|141395118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.7||||0.014||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 16:00||||0.014
70947334|NCT00935259|141395118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5|||<|0.001||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 18:3n3||||<0.001
70947335|NCT00935259|141395118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.217||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 20:3n6||||0.217
70947336|NCT00935259|141395118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.666||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 20:3n9||||0.666
70947337|NCT00935259|141395118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.776||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 22:5n6||||0.776
70947338|NCT00935259|141395118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.018||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 22:6n3||||0.018
70947339|NCT00935259|141395118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.152||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Lysophosphatidylcholine 20:4n6||||0.152
70947340|NCT00935259|141395118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-132.1||||0.007||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylcholine 18:2n6||||0.007
71132315|NCT01724866|141767387|SUPERIORITY||Percent Difference|-6.2||||0.469|TWO_SIDED|95.0|-28.5|16.9|||Fisher Exact|||||16.9|-28.5|0.469
71132316|NCT01724866|141767387|SUPERIORITY||Percent Difference|-5.6||||0.71|TWO_SIDED|95.0|-29.3|18.7|||Fisher Exact|||||18.7|-29.3|0.710
70872078|NCT02155608|141229488|SUPERIORITY|||||||0.91||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .01; df = 1/46.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.91
71132317|NCT01724866|141767387|SUPERIORITY||Percent Difference|-11.1||||0.199|TWO_SIDED|95.0|-34.6|13.3|||Fisher Exact|||||13.3|-34.6|0.199
71132318|NCT01980095|141767424|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||One-sample Z-test, RHB-105 subjects only|||||||0.001
71132319|NCT01957202|141767503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.255|||<|0.0001|TWO_SIDED|95.0|-2.895|-1.616|||Mixed Model ANOVA|||||-1.616|-2.895|<0.0001
71132320|NCT01957202|141767503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.566|||<|0.0001|TWO_SIDED|95.0|-3.208|-1.925|||Mixed Model ANOVA|||||-1.925|-3.208|<0.0001
71132321|NCT01957202|141767503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.531||||0.0003|TWO_SIDED|95.0|-2.342|-0.719|||Mixed Model ANOVA|||||-0.719|-2.342|0.0003
71132322|NCT01957202|141767503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.842|||<|0.0001|TWO_SIDED|95.0|-2.654|-1.029|||Mixed Model ANOVA|||||-1.029|-2.654|<0.0001
71132323|NCT01957202|141767503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.097|||<|0.0001|TWO_SIDED|95.0|-4.857|-3.337|||Mixed Model ANOVA|||||-3.337|-4.857|<0.0001
71132324|NCT01957202|141767503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.311||||0.3699|TWO_SIDED|95.0|-0.994|0.372|||Mixed Model ANOVA|||||0.372|-0.994|0.3699
71132325|NCT01957202|141767504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.364|||<|0.0001|TWO_SIDED|95.0|-1.853|-0.874|||Mixed Model ANOVA|||||-0.874|-1.853|<0.0001
71132326|NCT01957202|141767504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32||||0.1975|TWO_SIDED|95.0|-0.169|0.809|||Mixed Model ANOVA|||||0.809|-0.169|0.1975
71132327|NCT01957202|141767504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.252|||<|0.0001|TWO_SIDED|95.0|-1.87|-0.635|||Mixed Model ANOVA|||||-0.635|-1.870|<0.0001
71132328|NCT01957202|141767504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.432||||0.1648|TWO_SIDED|95.0|-0.179|1.042|||Mixed Model ANOVA|||||1.042|-0.179|0.1648
71132329|NCT01957202|141767504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.932||||0.0016|TWO_SIDED|95.0|-1.506|-0.358|||Mixed Model ANOVA|||||-0.358|-1.506|0.0016
71132330|NCT01957202|141767504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.684|||<|0.0001|TWO_SIDED|95.0|1.16|2.208|||Mixed Model ANOVA|||||2.208|1.160|<0.0001
71132331|NCT01957202|141767505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.174||||0.3052|TWO_SIDED|95.0|-0.508|0.16|||Mixed Model ANOVA|||||0.160|-0.508|0.3052
70860388|NCT01227564|141206994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.7146|TWO_SIDED|95.0|-3.4|2.35||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 54.||2.35|-3.40|0.7146
71132332|NCT01957202|141767505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.187||||0.2725|TWO_SIDED|95.0|-0.149|0.523|||Mixed Model ANOVA|||||0.523|-0.149|0.2725
71132333|NCT01957202|141767505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.536||||0.0118|TWO_SIDED|95.0|-0.952|-0.12|||Mixed Model ANOVA|||||-0.120|-0.952|0.0118
71132334|NCT01957202|141767505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.175||||0.4049|TWO_SIDED|95.0|-0.588|0.239|||Mixed Model ANOVA|||||0.239|-0.588|0.4049
71132335|NCT01957202|141767505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.349||||0.0793|TWO_SIDED|95.0|-0.739|0.041|||Mixed Model ANOVA|||||0.041|-0.739|0.0793
71132336|NCT01957202|141767505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.361||||0.0478|TWO_SIDED|95.0|0.004|0.719|||Mixed Model ANOVA|||||0.719|0.004|0.0478
71132337|NCT01957202|141767506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.215||||0.1502|TWO_SIDED|95.0|-0.509|0.079|||Mixed Model ANOVA|||||0.079|-0.509|0.1502
71132338|NCT01957202|141767506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.075||||0.6177|TWO_SIDED|95.0|-0.37|0.221|||Mixed Model ANOVA|||||0.221|-0.370|0.6177
71132339|NCT01957202|141767506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.701||||0.0004|TWO_SIDED|95.0|-1.08|-0.322|||Mixed Model ANOVA|||||-0.322|-1.080|0.0004
71132340|NCT01957202|141767506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.0035|TWO_SIDED|95.0|-0.934|-0.187|||Mixed Model ANOVA|||||-0.187|-0.934|0.0035
71132341|NCT01957202|141767506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.775|||<|0.0001|TWO_SIDED|95.0|-1.123|-0.428|||Mixed Model ANOVA|||||-0.428|-1.123|<0.0001
71132342|NCT01957202|141767506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.3807|TWO_SIDED|95.0|-0.175|0.456|||Mixed Model ANOVA|||||0.456|-0.175|0.3807
71132343|NCT04808141|141767507|EQUIVALENCE|For a power of 80% and a two-sided 0.05 significance level, we calculated that 102 individuals would be necessary to detect a 10-point difference between the two groups. To guarantee that the study was adequately powered to detect equivalence, a posteriori analysis was conducted using the Two One-Sided Test (TOST) methodology (simulation-based power analysis).|Median Difference (Net)|-0.55||||0.412|TWO_SIDED|95.0|-2.42|5.81||the threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|robust method on the medians||||5.81|-2.42|0.412
71132344|NCT04808141|141767507|EQUIVALENCE||Odds Ratio (OR)|0.926||||0.849|TWO_SIDED|95.0|0.42|2.05||The threshold for statistical analysis was set at 0.05.|Regression, Logistic|||||2.05|0.42|0.849
71132345|NCT04808141|141767508|EQUIVALENCE||Median Difference (Net)|0.3||||0.666|TWO_SIDED|95.0|-0.71|1.1||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|robust method on the medians||||1.10|-0.71|0.666
71132346|NCT04808141|141767509|EQUIVALENCE||Median Difference (Net)|-2.62||||0.122|TWO_SIDED|95.0|-14.87|4.8||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|Robust test on the medians||||4.80|-14.87|0.122
71132347|NCT04808141|141767510|EQUIVALENCE||Median Difference (Net)|3.32||||0.788|TWO_SIDED|95.0|-3.11|5.9||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|Robust method on the medians||||5.90|-3.11|0.788
71132348|NCT04808141|141767511|EQUIVALENCE||Odds Ratio (OR)|0.92||||0.081|TWO_SIDED|95.0|0.0|1.23||The threshold for statistical significance was set at 0.05.|Regression, Logistic|LR to assess the odds between groups for consuming analgesics at 8 weeks using the CG as a reference.||||1.23|0.00|0.081
71132349|NCT04808141|141767511|EQUIVALENCE||Odds Ratio (OR)|0.26||||0.985|TWO_SIDED|95.0|0.0|1.71||The threshold for statistical significance was set at 0.05.|Regression, Logistic|LR to assess the odds between groups for consuming opioids at 8 weeks using the CG as a reference.||||1.71|0.00|0.985
71132350|NCT04808141|141767512|EQUIVALENCE||Median Difference (Net)|-0.42||||0.871|TWO_SIDED|95.0|-2.1|1.78||the threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|Robust method on the medians||||1.78|-2.10|0.871
71132351|NCT04808141|141767513|EQUIVALENCE||Median Difference (Final Values)|0.43||||0.36|TWO_SIDED|95.0|-0.59|1.59||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|Robust method on the medians||||1.59|-0.59|0.360
71132352|NCT04808141|141767514|EQUIVALENCE||Mean Difference (Final Values)|0.09||||0.837|TWO_SIDED|||||The threshold for statistical significance was set at 0.05.|t-test, 2 sided|||||||0.837
71132353|NCT04808141|141767515|EQUIVALENCE||Z-score|-1.28||||0.886|TWO_SIDED|||||The threshold for statistical significance was 0.05.|Ordinal Regression|||||||0.886
71132354|NCT04808141|141767516|EQUIVALENCE||Median Difference (Net)|1.33||||0.095|TWO_SIDED|95.0|-2.2|2.46||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|Robust method on the medians||||2.46|-2.20|0.095
71132355|NCT04808141|141767518|EQUIVALENCE||Mean Difference (Final Values)|65.8||||0.662|TWO_SIDED|||||The threshold for statistical significance was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.662
71132356|NCT04808141|141767519|EQUIVALENCE||Median Difference (Net)|-1.97||||0.246|TWO_SIDED|95.0|-12.69|3.33|||Quantile mixed-effects model|Robust method on the medians||||3.33|-12.69|0.246
71132357|NCT04808141|141767520|EQUIVALENCE||Median Difference (Net)|-0.73||||0.408|TWO_SIDED|95.0|-6.5|2.69||the threshold for statistical significance was set at 0.05|Quantile mixed-effects model|Robust method on the medians.||||2.69|-6.50|0.408
71132358|NCT04808141|141767521|EQUIVALENCE||Median Difference (Net)|0.35||||0.65|TWO_SIDED|95.0|-6.22|9.87||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|Robust method on the medians||||9.87|-6.22|0.650
71132359|NCT04808141|141767522|EQUIVALENCE||Difference in proportions|18.6||||0.019|TWO_SIDED||||||Chi-squared|||||||0.019
71132360|NCT00632619|141767616|SUPERIORITY_OR_OTHER|||||||0.106|||||||ANOVA|||A 2 x 2 repeated measures analysis (with time as within-subject factor and group as between-subject factor) was performed to compare the two groups on this measure at two time points (i.e., baseline at week 0 and endpoint at week 12) and infer treatment success accordingly. The null hypothesis signified that there would be no difference between the groups over time, thus, there would be no difference in treatments. Statistical power was calculated as Cohen's d.||||0.106
71132361|NCT00632619|141767617|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANOVA|||A 2 x 2 repeated measures analysis (with time as within-subject factor and group as between-subject factor) was performed to compare the two groups on this measure at two time points (i.e., baseline which was week 0 and endpoint at week 12) and infer treatment success accordingly. The null hypothesis signified that there would be no difference between the groups over time, thus, there would be no difference in treatments. Statistical power was calculated as Cohen's d.||||0.015
71132362|NCT00632619|141767618|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||ANOVA|||A 2 x 2 repeated measures analysis (with time as within-subject factor and group as between-subject factor) was conducted to compare the two groups on this measure at two time points (i.e., baseline at week 0 and endpoint at week 12) and infer treatment success accordingly. The null hypothesis signified that there would be no difference between the groups over time, thus, there would be no difference in treatments. Statistical power was calculated as Cohen's d.||||0.38
71132363|NCT00632619|141767619|SUPERIORITY_OR_OTHER|||||||0.016|||||||ANOVA|||A 2 x 2 repeated measures analysis (with time as within-subject factor and group as between-subject factor) was performed to compare the two groups on this measure at two time points (i.e., baseline at week 0 and endpoint at week 12) and infer treatment success accordingly. The null hypothesis signified that there would be no difference between the groups over time, thus, there would be no difference in treatments. Statistical power was calculated as Cohen's d.||||0.016
71132364|NCT00632619|141767620|SUPERIORITY_OR_OTHER|||||||0.095|||||||ANOVA|||A 2 x 2 repeated measures analysis (with time as within-subject factor and group as between-subject factor) was performed to compare the two groups on this measure at two time points (i.e., baseline at week 0 and endpoint at week 12) and infer treatment success accordingly. The null hypothesis signified that there would be no difference between the groups over time, thus, there would be no difference in treatments. Statistical power was calculated as Cohen's d.||||0.095
71132365|NCT04531241|141767626|NON_INFERIORITY|It was calculated that 120 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect a 5 points difference in mean overall comfort and vision at the 1-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05). A non-inferiority margin of -5 points was used.|Least-Square Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|2.01|||TWO_SIDED|95.0|-6.8|1.1|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|||1.1|-6.8|
71132366|NCT04531241|141767627|NON_INFERIORITY|It was calculated that 120 participants randomized in a 1:1 fashion between the two sequences would have a 0.05 logMAR unit difference in logMAR visual acuity at LLHC and HLLC lighting conditions at the 1-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05). A non-inferiority margin of 0.05 logMAR units was used.|Least-Square Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.005|||TWO_SIDED|95.0|-0.0199|0.0|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|Low Luminance High Contrast||0.0|-0.0199|
71132367|NCT04531241|141767627|NON_INFERIORITY|It was calculated that 120 participants randomized in a 1:1 fashion between the two sequences would have a 0.05 logMAR unit difference in logMAR visual acuity at LLHC and HLLC lighting conditions at the 1-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05). A non-inferiority margin of 0.05 logMAR units was used.|Least-Square Mean Difference|-0.004|STANDARD_ERROR_OF_MEAN|0.0066|||TWO_SIDED|95.0|-0.0173|0.0087|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|High Luminance Low Contrast||0.0087|-0.0173|
71132368|NCT04531241|141767628|NON_INFERIORITY|It was calculated that 120 participants randomized in a 1:1 fashion between the two sequences would have a 1 hour difference in average daily wear time at the 1-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05). A non-inferiority margin of 1 hour was used.|Least-Square Mean Difference|-0.052|STANDARD_ERROR_OF_MEAN|0.0731|||TWO_SIDED|95.0|-0.1968|0.0933|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|||0.0933|-0.1968|
71132369|NCT04531241|141767629|NON_INFERIORITY|It was calculated that 120 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect a 5 points difference in mean overall comfort and vision at the 1-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05). A non-inferiority margin of -5 points was used.|Least-Square Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|1.47|||TWO_SIDED|95.0|-5.5|0.3|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|||0.3|-5.5|
71132370|NCT05723263|141767640|OTHER||Proportional difference|91.0|||<|0.01|TWO_SIDED|95.0|90.2|91.8||The threshold for statistical significance was p\<0.05.|Generalized Estimating Equations|||It was calculated that 12 clinic sites with 1200 participants randomized in a 1:1:1 ratio between the three arms, would have at least 90% power to detect a 10% difference in the proportion of test uptake between the pay-it-forward and control group participants, using a two-sided, two-sample t-test (α=0.05), assuming a 0.25\~0.31 cluster coefficient of variation, \<5% lost-to-follow-up rate, and an intra-class correlation of 0.016.||91.8|90.2|<0.01
71132371|NCT05723263|141767641|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
71132372|NCT05723263|141767642|OTHER|||||||0.0059|||||||Chi-squared|||||||0.0059
71132373|NCT05723263|141767643|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
71132374|NCT05723263|141767645|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71132375|NCT05723263|141767646|OTHER|||||||0.007|||||||t-test, 2 sided|||||||0.007
71132376|NCT05723263|141767647|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71132377|NCT05723263|141767648|OTHER|||||||0.727|||||||t-test, 2 sided|||||||0.727
70860389|NCT01227564|141206994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.64||||0.2733|TWO_SIDED|95.0|-4.6|1.33||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 54.||1.33|-4.60|0.2733
70860390|NCT01227564|141206994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.3969|TWO_SIDED|95.0|-3.62|1.46||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 54.||1.46|-3.62|0.3969
70860391|NCT01227564|141206994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.8566|TWO_SIDED|95.0|-2.43|2.92||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 86.||2.92|-2.43|0.8566
70860392|NCT01227564|141206994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.346|TWO_SIDED|95.0|-3.98|1.42||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 86.||1.42|-3.98|0.3460
70860393|NCT01227564|141206994|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.52||||0.6582|TWO_SIDED|95.0|-2.86|1.82||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 86.||1.82|-2.86|0.6582
70860394|NCT01227564|141206996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.7537|TWO_SIDED|95.0|-18.36|13.36||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||13.36|-18.36|0.7537
70860395|NCT01227564|141206996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.51||||0.1266|TWO_SIDED|95.0|-28.86|3.65||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||3.65|-28.86|0.1266
70860396|NCT01227564|141206996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.96||||0.6724|TWO_SIDED|95.0|-28.34|18.41||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||18.41|-28.34|0.6724
70860397|NCT01227564|141206996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.7||||0.017|TWO_SIDED|95.0|-53.89|-5.5||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||-5.50|-53.89|0.0170
70947341|NCT00935259|141395118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.8||||0.325||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylcholine 20:3n6||||0.325
71132378|NCT04765202|141767656|SUPERIORITY||Percentage Difference|14.3||||1|TWO_SIDED|95.0|-11.64|40.21|||Fisher Exact||Difference was calculated as (percent area of wound closure in SOMA Tx site) - ((percent area of wound closure in AG Tx site). 95% CI was derived using the normal approximation to binomial distribution.|Comparison of complete wound closure without additional autografting at Month 2 in AG TX site and SOMA TX site in Cohort 1 Group 1.||40.21|-11.64|1.0000
71132379|NCT04765202|141767656|SUPERIORITY||Percentage Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Difference was calculated as (percent area of wound closure in SOMA Tx site) - ((percent area of wound closure in AG Tx site). 95% CI was derived using the normal approximation to binomial distribution.|Comparison of complete wound closure without additional autografting at Month 2 in AG TX site and SOMA TX site in Cohort 1 Group 2.||0|0|
71132380|NCT01635855|141767666|SUPERIORITY_OR_OTHER||One-sided binomial|8.5|||<|0.025|TWO_SIDED|95.0|3.5|13.6||Ho (null): Ps \>= 22% versus Ha (alternate): Ps \< 22% where Ps is the proportion of subjects with common severe adverse events in the post-approval study. Ho is rejected if upper limit of the 95% CI of Ps \< 22% and the one-sided p-value \<= 0.025.|One sided binomial distribution|The upper limit of the 95% two-sided CI for a proportion is equivalent to the 97.5% one-sided CI for that proportion for normal approximations.||The analysis was performed by comparing the proportion of subjects with severe common adverse events in the post-market study to that occurred in the pre-market studies. It was pre-specified in the protocol that the proportion of subjects with severe common adverse events in the pre-market studies was 22%.||13.6|3.5|< 0.025
71132381|NCT03828019|141767667|SUPERIORITY||Odds Ratio (OR)|1.86||||0.029|TWO_SIDED|95.0|1.06|3.25|||Regression, Logistic|Adjusted for the 2 stratification variables (initial prednisone dose and immunosuppression use at baseline).|Estimated parameter is the Odds Ratios (ADA/CID). Result greater than 1 indicates ADA is superior in achieving successful corticosteroid sparing|The sample size estimation: Adalimumab was estimated to be successful in 75% of patients. The overall success rate with conventional immunosuppression was estimated to be 51%. A sample size of 222 (111 per treatment group) provided 90% power to detect a difference in cumulative percent of 75% versus 51%||3.25|1.06|0.029
71132382|NCT03828019|141767668|SUPERIORITY||Odds Ratio (OR)|1.91||||0.072|TWO_SIDED|95.0|0.94|3.86|||Regression, Logistic||Odds ADA/ Odds CID|Generalized estimating equations were used to fit logistic regression models to compare the cumulative proportion of corticosteroid sparing between the two treatment groups over time while accounting for correlation between replicate measurements on the same individual with an unstructured covariance matrix. 2 stratification variables (initial prednisone dose and immunosuppression use at baseline) were included||3.86|0.94|0.072
71132383|NCT03828019|141767669|SUPERIORITY||Odds Ratio (OR)|1.53||||0.3|TWO_SIDED|95.0|0.67|3.46|||Regression, Logistic||Odds ratio is ADA/CID where value greater than 1 indicates ADA is superior for corticosteroid (prednisone) discontinuation|Generalized estimating equations were used to fit logistic regression models to compare the cumulative proportion of corticosteroid sparing between the two treatment groups over time while accounting for correlation between replicate measurements on the same individual with an unstructured covariance matrix. 2 stratification variables (initial prednisone dose and immunosuppression use at baseline) were included||3.46|0.67|0.30
71132384|NCT03828019|141767670|SUPERIORITY||Odds Ratio (OR)|1.85||||0.028|TWO_SIDED|95.0|1.06|3.19|||Regression, Logistic||Odds ADA/ Odds CID where value greater than 1 indicate greater corticosteroid sparing success in the ADA group|Generalized estimating equations were used to fit logistic regression models to compare the cumulative proportion of corticosteroid discontinuation between the two treatment groups over time while accounting for correlation between replicate measurements on the same individual with an unstructured covariance matrix. 2 stratification variables (initial prednisone dose and immunosuppression use at baseline) were included||3.19|1.06|0.028
71132385|NCT03828019|141767671|SUPERIORITY||Ratio of rate of steroid (mg/day ADA/CID|0.86||||0.061|TWO_SIDED|95.0|0.73|1.01|||negative binomial model||Number greater than 1 would indicate rate of steroid use is higher in participants assigned to ADA|||1.01|0.73|0.061
71132386|NCT03828019|141767672|SUPERIORITY||Difference in mean change from BL|0.4||||0.77|TWO_SIDED|95.0|-2.3|3.1|||Mixed Models Analysis|||Mixed effects models were used with a linear link. The fixed effects included initial steroid dose and immunosuppression use at baseline. Additional visit indicators (months 1-12) and corresponding treatment by visit interaction terms. An unstructured correlation was used to model repeated measurements by eye . A person-level random intercept was added to account for between-eye correlations.||3.1|-2.3|0.77
71132387|NCT03828019|141767673|SUPERIORITY||Ratio of odds ratios|0.55||||0.028|TWO_SIDED|95.0|0.31|0.94|||Regression, Logistic||estimate is the ratio of odds ratios - OR ADA / OR CID. Value less than 1 indicates ADA is better at reducing macular edema.|Mixed effects models with a log link were used to assess treatment differences . The outcome measure was the odds ratio of having macular edema (OCT central subfield thickness \> 300 um) at 12 months compared to baseline (BL). The treatment effect was the ratio of Odds ratios (ADA/CID) at 12 months. Values less than one indicate improvement in macular edema for the ADA treatment group relative to the CID group. Decrease in subfield thickness is good||0.94|0.31|0.028
71132388|NCT03828019|141767674|SUPERIORITY||Risk Ratio (RR)|1.1||||0.76|TWO_SIDED|95.0|0.61|1.98|||negative binomial model|||||1.98|0.61|0.76
71132389|NCT03828019|141767675|SUPERIORITY||Cox Proportional Hazard|0.16||||0.014|TWO_SIDED|95.0|0.04|0.7|||Regression, Cox|||. Kaplan Meier techniques and Cox proportional hazards models were used to evaluate time to event outcomes||0.70|0.04|0.014
71132390|NCT03828019|141767676|SUPERIORITY||Cox Proportional Hazard|0.89||||0.74|TWO_SIDED|95.0|0.43|1.82|||Regression, Cox|||||1.82|0.43|0.74
71132391|NCT03828019|141767677|SUPERIORITY||Odds Ratio (OR)|0.76||||0.35|TWO_SIDED|95.0|0.43|1.34|||Ratio of odds ratios||Treatment comparison is the ratio of the odds ratios for each treatment group (ADA/CID) at 12 months. Values greater than one indicate greater improvement in health for the ADA treatment group relative to the CID group.|||1.34|0.43|0.35
71132392|NCT03828019|141767678|SUPERIORITY||Mean Difference (Net)|1.39||||0.24|TWO_SIDED|95.0|-0.95|3.73|||Mixed Models Analysis|||||3.73|-0.95|0.24
71132393|NCT03828019|141767679|SUPERIORITY||Mean Difference (Net)|0.59||||0.7|TWO_SIDED|95.0|-2.43|3.61|||Mixed Models Analysis|||||3.61|-2.43|0.70
71132394|NCT03828019|141767680|SUPERIORITY||Mean Difference (Net)|1.6||||0.28|TWO_SIDED|95.0|-1.4|4.6|||Mixed Models Analysis|||||4.6|-1.4|0.28
71132395|NCT03828019|141767681|SUPERIORITY||Hazard Ratio (HR)|0.21||||0.009|TWO_SIDED|95.0|0.07|0.67|||Regression, Cox|||||0.67|0.07|0.009
70947342|NCT00935259|141395118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.3||||0.419||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylcholine 20:4n6||||0.419
70860398|NCT01227564|141206996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.94||||0.3196|TWO_SIDED|95.0|-92.67|30.78||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||30.78|-92.67|0.3196
70872079|NCT02155608|141229488|SUPERIORITY|||||||0.11||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 2.62, df = 1/46.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.11
70860399|NCT01227564|141206996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-64.97||||0.049|TWO_SIDED|95.0|-129.64|-0.31||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||-0.31|-129.64|0.0490
70872080|NCT02155608|141229488|SUPERIORITY|||||||0.4||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .71; df = .40.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.40
71132396|NCT03401671|141767710|OTHER|Analysis was performed for estimation of least square means only. Descriptive statistical analysis was the main analysis.|Ratio of Geometric least squares Means|1.0229|||||TWO_SIDED|90.0|0.8473|1.2349||||||An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and ethnic group as a fixed effect.||1.2349|0.8473|
70860400|NCT01227564|141206996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.04||||0.2969|TWO_SIDED|95.0|-14.7|46.79||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||46.79|-14.70|0.2969
70872081|NCT02155608|141229488|SUPERIORITY|||||||0.49||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .48. df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.49
71132397|NCT03401671|141767712|OTHER|Analysis was performed for estimation of least square means only. Descriptive statistical analysis was the main analysis.|Ratio of Geometric least squares Means|0.9324|||||TWO_SIDED|90.0|0.8016|1.0846||||||An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and ethnic group as a fixed effect.||1.0846|0.8016|
71132398|NCT03401671|141767713|OTHER|Analysis was performed for estimation of least square means only. Descriptive statistical analysis was the main analysis.|Ratio of Geometric least squares Means|0.9318|||||TWO_SIDED|90.0|0.8005|1.0846||||||An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and ethnic group as a fixed effect.||1.0846|0.8005|
71132399|NCT04090242|141767730|OTHER||Mean Difference (Final Values)|-0.16||||0.392|TWO_SIDED|95.0|-0.53|0.21||The p value is for the comparison between interventional and control group on change of DES score between baseline and end of study.|Mixed Models Analysis|||With assumptions made in statistical analysis plan, a sample size of 43 subjects per arm had \>80% power to detect a significant difference between the two arms (based on a 2-sided t-test, 95% CI for DES difference between groups). Adding a 10% buffer, planned enrollment was 96 subjects. However, enrollment ended early with about 25 subjects in each arm (56 subjects total). Thus, power decreased to 56%. The study was not sufficiently powered under these conditions.||0.21|-0.53|0.392
71132400|NCT01898013|141767747|SUPERIORITY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.25||0.02|TWO_SIDED|||||a priori threshold set at 0.05|Mixed Models Analysis|||||||0.02
71132401|NCT01898013|141767748|SUPERIORITY||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.14||0.26|TWO_SIDED||||||Mixed Models Analysis|||||||0.26
71132402|NCT01898013|141767749|SUPERIORITY||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|0.12||0.79|TWO_SIDED||||||Mixed Models Analysis|||||||0.79
71132403|NCT01898013|141767750|SUPERIORITY||Mean Difference (Final Values)|1.18|STANDARD_ERROR_OF_MEAN|0.16||0.23|TWO_SIDED||||||Mixed Models Analysis|||||||0.23
71132404|NCT01898013|141767751|SUPERIORITY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.13||0.63|TWO_SIDED||||||Mixed Models Analysis|||||||0.63
71132405|NCT01898013|141767752|SUPERIORITY||Mean Difference (Final Values)|1.06|STANDARD_ERROR_OF_MEAN|0.13||0.62|TWO_SIDED||||||Mixed Models Analysis|||||||0.62
71132406|NCT03182907|141767757|OTHER|The AUC0-inf of bezlotoxumab in Cohort 1 was compared to the AUC0-inf of bezlotoxumab in adults using an analysis of variance (ANOVA) model. The comparison adult PK dataset used was based on participants from 2 adult trials (NCT01241552 and NCT01513239) as a historical control.|Geometric Mean Ratio (GMR)|1.06|||||TWO_SIDED|90.0|0.95|1.18|||||GMR was calculated as the Cohort 1 geometric mean (GM) AUC0-inf / Adult GM AUC0-inf.|||1.18|0.95|
71132407|NCT03182907|141767757|OTHER|The AUC0-inf of bezlotoxumab in Cohort 2 was compared to the AUC0-inf of bezlotoxumab in adults using an analysis of variance (ANOVA) model. The comparison adult PK dataset used was based on participants from 2 adult trials (NCT01241552 and NCT01513239) as a historical control.|GMR|0.82|||||TWO_SIDED|90.0|0.75|0.89|||||GMR was calculated as the Cohort 2 GM AUC0-inf / Adult GM AUC0-inf.|||0.89|0.75|
71132408|NCT03182907|141767758|OTHER|Miettinen \& Nurminen method was used to generate the estimated difference in percentage and associated 95% confidence intervals (CIs) in bezlotoxumab versus placebo arms.|Difference in percentage|-5.7|||||TWO_SIDED|95.0|-14.5|7.7||||||||7.7|-14.5|
71132409|NCT03182907|141767759|OTHER|Miettinen \& Nurminen method was used to generate the estimated difference in percentage and associated 95% CIs in bezlotoxumab versus placebo arms.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-9.7|3.5||||||||3.5|-9.7|
71132410|NCT03182907|141767760|OTHER|Miettinen and Nurminen method stratified by age cohort (12 to \<18 years of age, 1 to \<12 years of age) with a Cochran-Mantel-Haenszel weight was used to generate the treatment difference, associated 95% CIs and a 2-sided p-value.|Adjusted difference|-3.7|||=|0.5701|TWO_SIDED|95.0|-20.0|8.0|||Stratified Miettinen and Nurminen method|||||8.0|-20.0|= 0.5701
71132411|NCT03182907|141767761|OTHER|Miettinen and Nurminen method stratified by age cohort (12 to \<18 years of age, 1 to \<12 years of age) with a Cochran-Mantel-Haenszel weight was used to generate the treatment difference, associated 95% CIs and a 2-sided p-value.|Adjusted difference|0.8|||=|0.9165|TWO_SIDED|95.0|-11.8|17.6|||Stratified Miettinen and Nurminen method|||||17.6|-11.8|= 0.9165
71132412|NCT03182907|141767762|OTHER|Unstratified Miettinen and Nurminen method was used to generate the treatment difference, associated 95% CIs and a 2-sided p-value.|Adjusted Difference|-3.1|||=|0.6542|TWO_SIDED|95.0|-19.9|9.0|||Unstratified Miettinen & Nurminen method|||||9.0|-19.9|= 0.6542
71132413|NCT03182907|141767763|OTHER|Unstratified Miettinen and Nurminen method was used to generate treatment difference, associated 95% CIs and a 2-sided p-value.|Adjusted difference|0.1|||=|0.9873|TWO_SIDED|95.0|-13.0|17.4|||Unstratified Miettinen & Nurminen method|||||17.4|-13.0|= 0.9873
71132414|NCT00429169|141767767|SUPERIORITY_OR_OTHER||regression coefficient|-0.29||||0.03|TWO_SIDED|95.0|-0.57|-0.023||The p-value applies to the interaction term of Treatment X Baseline Suicidal Ideation severity.|Mixed Models Analysis|||Generalized least squares model of Scale for Suicidal Ideation score during 8-week acute treatment of major depressive disorder.||-0.023|-0.57|0.03
70947343|NCT00935259|141395118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7||||0.07||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylcholine 22:5n3||||0.070
70947344|NCT00935259|141395118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.769||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylcholine 22:5n6||||0.769
70872082|NCT02155608|141229488|SUPERIORITY|||||||0.18||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 1.87, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.18
70872083|NCT02155608|141229488|SUPERIORITY|||||||0.72||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .13, df = 1/38.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.72
70947345|NCT00935259|141395118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.1|||<|0.001||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylethanolamine 18:2n6||||<0.001
70947346|NCT00935259|141395118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-240.8||||0.016||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Triacylglycerol 16:00||||0.016
70860401|NCT01227564|141206996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.2||||0.0973|TWO_SIDED|95.0|-57.42|5.03||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||5.03|-57.42|0.0973
70947347|NCT00935259|141395118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.833||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Triacylglycerol 20:3n9||||0.833
70947348|NCT00935259|141395119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.027||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Fasted||||0.027
70947349|NCT00935259|141395119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|||<|0.001||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Fed||||<0.001
70947350|NCT00935259|141395121|SUPERIORITY_OR_OTHER|||||||0.247||95.0|||||Mixed Models Analysis|||Cholesterol ester c20:4n6 / c20:3n6||||0.247
70947351|NCT00935259|141395121|SUPERIORITY_OR_OTHER|||||||0.151||95.0|||||Mixed Models Analysis|||Cholesterol ester c20:5n3 / c20:4n3||||0.151
70947352|NCT03856047|141395122|SUPERIORITY||Treatment difference (%-points)|-2.99|STANDARD_ERROR_OF_MEAN|0.81||0.0002|TWO_SIDED|95.0|-4.58|-1.4|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance (ANCOVA) model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-1.40|-4.58|0.0002
70947353|NCT03856047|141395122|SUPERIORITY||Treatment difference (%-points)|-3.78|STANDARD_ERROR_OF_MEAN|0.82|<|0.0001|TWO_SIDED|95.0|-5.38|-2.17|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-2.17|-5.38|<.0001
71132415|NCT02815644|141767788|SUPERIORITY_OR_OTHER||T/R ratio|55.69|STANDARD_ERROR_OF_MEAN|1.087|||TWO_SIDED|90.0|48.22|64.33|||||Standard Error of the mean is actually geometric Standard Error of the mean.|"Relative bioavailability of linagliptin after food intake compared to while in the fasting state was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||64.33|48.22|
71132416|NCT02815644|141767789|SUPERIORITY_OR_OTHER||T/R ratio|74.89|STANDARD_ERROR_OF_MEAN|1.073|||TWO_SIDED|90.0|66.27|84.64|||||Standard Error of the mean is actually geometric Standard Error of the mean|"Relative bioavailability of empagliflozin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||84.64|66.27|
71132417|NCT02815644|141767790|SUPERIORITY_OR_OTHER||T/R ratio|82.19|STANDARD_ERROR_OF_MEAN|1.028|||TWO_SIDED|90.0|78.38|86.18|||||Standard Error of the mean is actually geometric Standard Error of the mean|"Relative bioavailability of linagliptin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||86.18|78.38|
70872084|NCT02155608|141229489|SUPERIORITY|||||||0.62|||||||Mixed Models Analysis|Group: F =.25, df = 1/53.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.62
70872085|NCT02155608|141229489|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|Time: F = 3.58, df = 1/53.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.06
70947354|NCT03856047|141395122|SUPERIORITY||Treatment difference (%-points)|-6.07|STANDARD_ERROR_OF_MEAN|0.87|<|0.0001|TWO_SIDED|95.0|-7.77|-4.36|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-4.36|-7.77|<.0001
70947355|NCT03856047|141395122|SUPERIORITY||Treatment difference (%-points)|-6.68|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-8.28|-5.09|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-5.09|-8.28|<.0001
70947356|NCT03856047|141395122|SUPERIORITY||Treatment difference (%-points)|-7.79|STANDARD_ERROR_OF_MEAN|0.83|<|0.0001|TWO_SIDED|95.0|-9.42|-6.16|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-6.16|-9.42|<.0001
70860402|NCT01227564|141206997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.42||||0.6653|TWO_SIDED|95.0|-7.94|5.1||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||5.10|-7.94|0.6653
70860403|NCT01227564|141206997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.48||||0.4613|TWO_SIDED|95.0|-4.2|9.15||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||9.15|-4.20|0.4613
70860404|NCT01227564|141206997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72||||0.771|TWO_SIDED|95.0|-4.18|5.61||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||5.61|-4.18|0.7710
70860405|NCT01227564|141206997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.02||||0.2328|TWO_SIDED|95.0|-1.99|8.04||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||8.04|-1.99|0.2328
70860406|NCT01227564|141206997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.3693|TWO_SIDED|95.0|-0.97|2.58||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||2.58|-0.97|0.3693
70860407|NCT01227564|141206997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74||||0.422|TWO_SIDED|95.0|-1.09|2.56||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||2.56|-1.09|0.4220
71132418|NCT02815644|141767791|SUPERIORITY_OR_OTHER||T/R ratio|85.99|STANDARD_ERROR_OF_MEAN|1.018|||TWO_SIDED|90.0|83.38|88.68|||||Standard Error of the mean is actually geometric Standard Error of the mean|"Relative bioavailability of empagliflozin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||88.68|83.38|
70860408|NCT01227564|141206997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.51||||0.3728|TWO_SIDED|95.0|-24.25|9.23||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||9.23|-24.25|0.3728
70860409|NCT01227564|141206997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.07||||0.3452|TWO_SIDED|95.0|-25.05|8.91||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||8.91|-25.05|0.3452
70860410|NCT02378025|141207043|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||.25
70860411|NCT02378025|141207044|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||.08
70860412|NCT02378025|141207045|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||.04
70860413|NCT02378025|141207046|SUPERIORITY|||||||0.25|||||||Regression, Logistic|||||||.25
71132419|NCT02815644|141767792|SUPERIORITY_OR_OTHER||T/R ratio|88.13|STANDARD_ERROR_OF_MEAN|1.051|||TWO_SIDED|90.0|80.89|96.03|||||Standard Error of the mean is actually geometric Standard Error of the mean|"Relative bioavailability of linagliptin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||96.03|80.89|
70860414|NCT02378025|141207047|SUPERIORITY|||||||0.22|||||||Regression, Logistic|||||||.22
70860415|NCT02378025|141207048|SUPERIORITY|||||||0.41|||||||Regression, Logistic|||||||.41
70860416|NCT01476644|141207068|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Regression, Linear|||||||<0.01
70860417|NCT00495131|141207083|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||Null hypothesis: no difference between 2 groups SVR estimation: 24 weeks (60%), 48 weeks (75%) alfa erros: 0.05, power: 0.80||||< 0.001
70860418|NCT00744471|141207086|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-1.28|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.87|-0.69||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: Analysis of Covariance (ANCOVA) was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.69|-1.87|<0.001
70860419|NCT00744471|141207086|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.69|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.28|-1.1||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.10|-2.28|<0.001
70860420|NCT00744471|141207086|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.75|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.34|-1.16||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.16|-2.34|<0.001
70860421|NCT00744471|141207087|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.74|-0.61||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value, as a covariate, and study site as a random effect.||-0.61|-1.74|<0.001
70860422|NCT00744471|141207087|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.49|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.06|-0.92||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.92|-2.06|<0.001
70860423|NCT00744471|141207087|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.61|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.17|-1.04||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.04|-2.17|<0.001
70860424|NCT00744471|141207088|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.51|-0.13||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA model includes treatment as main effect, baseline value as a covariate, and study site as a random effect.||-0.13|-0.51|0.001
70860425|NCT00744471|141207088|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.64|-0.25||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA model includes treatment as main effect, baseline value as a covariate, and study site as a random effect.||-0.25|-0.64|<0.001
70860426|NCT00744471|141207088|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.66|-0.28||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA model includes treatment as main effect, baseline value as a covariate, and study site as a random effect.||-0.28|-0.66|<0.001
70860427|NCT00744471|141207089|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.41|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.93|-0.88||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.88|-1.93|<0.001
70860428|NCT00744471|141207089|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.73|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.26|-1.2||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.20|-2.26|<0.001
70860429|NCT00744471|141207089|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.85|-0.8||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.80|-1.85|<0.001
70860430|NCT00744471|141207089|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.57|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.11|-1.02||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.02|-2.11|<0.001
70860431|NCT00744471|141207089|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.03|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.57|-1.48||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.48|-2.57|<0.001
70947357|NCT03856047|141395122|SUPERIORITY||Treatment difference (%-points)|-5.98|STANDARD_ERROR_OF_MEAN|0.83|<|0.0001|TWO_SIDED|95.0|-7.61|-4.35|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-4.35|-7.61|<.0001
70860432|NCT00744471|141207089|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.95|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.5|-1.41||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.41|-2.50|<0.001
70860433|NCT00744471|141207089|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.09|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.65|-0.53||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.53|-1.65|<0.001
70860434|NCT00744471|141207089|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.2|-1.08||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.08|-2.20|<0.001
70860435|NCT00744471|141207089|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.56|-1.45||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.45|-2.56|<0.001
70860436|NCT00744471|141207089|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.49|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.1|-0.88||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.88|-2.10|<0.001
70860437|NCT00744471|141207089|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.85|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.46|-1.25||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.25|-2.46|<0.001
70872086|NCT02155608|141229489|SUPERIORITY|||||||0.09||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 2.90, df 1/53.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.09
70860438|NCT00744471|141207089|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.97|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.57|-1.37||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.37|-2.57|<0.001
70860439|NCT00744471|141207089|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.16|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.75|-0.56||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.56|-1.75|<0.001
70860440|NCT00744471|141207089|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.52|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.12|-0.92||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.92|-2.12|<0.001
70860441|NCT00744471|141207089|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.2|-1.01||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.01|-2.20|<0.001
70860442|NCT00744471|141207090|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.41|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.93|-0.88||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.88|-1.93|<0.001
70860443|NCT00744471|141207090|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.73|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.26|-1.2||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.20|-2.26|<0.001
70860444|NCT00744471|141207090|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.85|-0.8||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.80|-1.85|<0.001
70860445|NCT00744471|141207090|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.55|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.08|-1.02||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.02|-2.08|<0.001
70860446|NCT00744471|141207090|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.99|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.52|-1.46||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.46|-2.52|<0.001
70860447|NCT00744471|141207090|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.01|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.54|-1.48||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.48|-2.54|<0.001
70860448|NCT00744471|141207090|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.17|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.71|-0.63||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.63|-1.71|<0.001
70860449|NCT00744471|141207090|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.66|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.21|-1.12||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.12|-2.21|<0.001
70860450|NCT00744471|141207090|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.06|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.6|-1.52||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.52|-2.60|<0.001
70860451|NCT00744471|141207090|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.55|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.11|-0.99||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.99|-2.11|<0.001
70860452|NCT00744471|141207090|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.88|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.45|-1.32||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.32|-2.45|<0.001
70860453|NCT00744471|141207090|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.26|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.82|-1.7||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.70|-2.82|<0.001
70860454|NCT00744471|141207090|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.82|-0.71||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.71|-1.82|<0.001
70860455|NCT00744471|141207090|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.59|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.15|-1.03||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.03|-2.15|<0.001
70860456|NCT00744471|141207090|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.96|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.51|-1.4||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.40|-2.51|<0.001
70860457|NCT00744471|141207090|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.29|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.85|-0.72||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.72|-1.85|<0.001
70860458|NCT00744471|141207090|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.58|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.15|-1.01||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.01|-2.15|<0.001
70860459|NCT00744471|141207090|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.83|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.4|-1.27||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.27|-2.40|<0.001
70860460|NCT00744471|141207091|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.83|-0.8||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.80|-1.83|<0.001
70860461|NCT00744471|141207091|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.71|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.23|-1.19||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.19|-2.23|<0.001
70860462|NCT00744471|141207091|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.83|-0.8||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.80|-1.83|<0.001
70860463|NCT00744471|141207091|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.12|-1.08||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.08|-2.12|<0.001
70860464|NCT00744471|141207091|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.12|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.64|-1.6||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.60|-2.64|<0.001
70947358|NCT03856047|141395122|SUPERIORITY||Treatment difference (%-points)|2.99|STANDARD_ERROR_OF_MEAN|0.82||0.0003|TWO_SIDED|95.0|1.38|4.6|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||4.60|1.38|0.0003
70860465|NCT00744471|141207091|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.94|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.46|-1.43||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.43|-2.46|<0.001
70860466|NCT00744471|141207091|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.72|-0.64||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.64|-1.72|<0.001
70860467|NCT00744471|141207091|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.18|-1.09||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.09|-2.18|<0.001
70860468|NCT00744471|141207091|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.89|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.43|-1.35||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.35|-2.43|<0.001
70860469|NCT00744471|141207091|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.35|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.93|-0.77||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.77|-1.93|<0.001
70860470|NCT00744471|141207091|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.73|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.31|-1.15||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12 :Analysis of Covariance (ANCOVA) was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.15|-2.31|<0.001
70860471|NCT00744471|141207091|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.89|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.47|-1.32||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.32|-2.47|<0.001
70860472|NCT00744471|141207091|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.52|-0.4||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24 : ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.40|-1.52|<0.001
70860473|NCT00744471|141207091|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.35|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.91|-0.78||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24 :Analysis of Covariance (ANCOVA) was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.78|-1.91|<0.001
70860474|NCT00744471|141207091|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.53|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.09|-0.97||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24 :Analysis of Covariance (ANCOVA) was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.97|-2.09|<0.001
70947359|NCT03856047|141395122|SUPERIORITY||Treatment difference (%-points)|2.2|STANDARD_ERROR_OF_MEAN|0.83||0.0082|TWO_SIDED|95.0|0.57|3.84|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||3.84|0.57|0.0082
70860475|NCT00744471|141207092|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.83|-0.8||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.80|-1.83|<0.001
70860476|NCT00744471|141207092|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.71|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.23|-1.19||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.19|-2.23|<0.001
70860477|NCT00744471|141207092|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.83|-0.8||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.80|-1.83|<0.001
70860478|NCT00744471|141207092|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.59|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.1|-1.08|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.08|-2.10|<0.001
70860479|NCT00744471|141207092|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.61|-1.59||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.59|-2.61|<0.001
70860480|NCT00744471|141207092|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.51|-1.49||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.49|-2.51|<0.001
70860481|NCT00744471|141207092|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.29|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.83|-0.76||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.76|-1.83|<0.001
70860482|NCT00744471|141207092|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.26|-1.19||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.19|-2.26|<0.001
70860483|NCT00744471|141207092|SUPERIORITY_OR_OTHER_LEGACY||Slope|-1.99|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.53|-1.46||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.46|-2.53|<0.001
70860484|NCT00744471|141207092|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.56|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.11|-1.0||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.00|-2.11|<0.001
70860485|NCT00744471|141207092|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.93|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.49|-1.37||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.37|-2.49|<0.001
70860486|NCT00744471|141207092|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.28|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.83|-1.72||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.72|-2.83|<0.001
70860487|NCT00744471|141207092|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.87|-0.75||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.75|-1.87|<0.001
70860488|NCT00744471|141207092|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.58|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.14|-1.02||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.02|-2.14|<0.001
70860489|NCT00744471|141207092|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.92|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.47|-1.36||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.36|-2.47|<0.001
70860490|NCT00744471|141207092|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.86|-0.74||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.74|-1.86|<0.001
70860491|NCT00744471|141207092|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.61|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.17|-1.05||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.05|-2.17|<0.001
70860492|NCT00744471|141207092|SUPERIORITY_OR_OTHER_LEGACY||Slope|-1.91|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.47|-1.36||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.36|-2.47|<0.001
70860493|NCT00744471|141207093|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.55|-0.18||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.18|-0.55|<0.001
70860494|NCT00744471|141207093|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.83|-0.45||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.45|-0.83|<0.001
70860495|NCT00744471|141207093|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.6|-0.22||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.22|-0.60|<0.001
70872087|NCT02155608|141229489|SUPERIORITY|||||||0.06||||||p \< .05 for statistical significance|Mixed Models Analysis|Group: F = 3.36, df = 1/58.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.06
70860496|NCT00744471|141207093|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.65|-0.27||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.27|-0.65|<0.001
70860497|NCT00744471|141207093|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.88|-0.5||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.50|-0.88|<0.001
70860498|NCT00744471|141207093|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.73|-0.36||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.36|-0.73|<0.001
70860499|NCT00744471|141207093|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.054|TWO_SIDED|95.0|-0.39|0.0||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||0.00|-0.39|0.054
70860500|NCT00744471|141207093|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.68|-0.29||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.29|-0.68|<0.001
70860501|NCT00744471|141207093|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.65|-0.26||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.26|-0.65|<0.001
70947360|NCT03856047|141395122|SUPERIORITY||Treatment difference (%-points)|-0.09|STANDARD_ERROR_OF_MEAN|0.88||0.9209|TWO_SIDED|95.0|-1.82|1.64|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||1.64|-1.82|0.9209
70947361|NCT03856047|141395122|SUPERIORITY||Treatment difference (%-points)|-0.7|STANDARD_ERROR_OF_MEAN|0.83||0.396|TWO_SIDED|95.0|-2.33|0.92|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||0.92|-2.33|0.3960
70947362|NCT03856047|141395122|SUPERIORITY||Treatment difference (%-points)|-1.81|STANDARD_ERROR_OF_MEAN|0.84||0.0316|TWO_SIDED|95.0|-3.46|-0.16|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-0.16|-3.46|0.0316
71132420|NCT02815644|141767793|SUPERIORITY_OR_OTHER||T/R ratio|86.33|STANDARD_ERROR_OF_MEAN|1.019|||TWO_SIDED|90.0|83.61|89.13|||||Standard Error of the mean is actually geometric Standard Error of the mean|"Relative bioavailability of empagliflozin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||89.13|83.61|
70947363|NCT00874497|141395155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0824||||0.1761|TWO_SIDED|95.0|-0.0378|0.2025||P-values are based on Analysis of Covariance (ANCOVA) model of the change FEV1 from baseline to the specified study week using treatment group and current smoking status as fixed effects and the baseline FEV1 value as a covariate.|ANCOVA|||Statistical analysis at Week 104.||0.2025|-0.0378|0.1761
70947364|NCT00874497|141395156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.904||||0.139|TWO_SIDED|95.0|-6.77|0.97|||ANCOVA|||Statistical analysis of Right Upper region of the lung at Week 104.||0.97|-6.77|0.139
70860502|NCT00744471|141207093|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.55|-0.15||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.15|-0.55|<0.001
70860503|NCT00744471|141207093|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.81|-0.4||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.40|-0.81|<0.001
70860504|NCT00744471|141207093|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.73|-0.32||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.32|-0.73|<0.001
70860505|NCT00744471|141207093|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.1||0.008|TWO_SIDED|95.0|-0.45|-0.07||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.07|-0.45|0.008
70860506|NCT00744471|141207093|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.22||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.22|-0.60|<0.001
70872088|NCT02155608|141229489|SUPERIORITY|||||||0.05||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 4.20, df = 1/31.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.05
70947365|NCT00874497|141395156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.46|TWO_SIDED|95.0|-4.46|2.04|||ANCOVA|||Statistical analysis of Right Middle region of the Lung at Week 104.||2.04|-4.46|0.460
70860507|NCT00744471|141207093|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.1||0.012|TWO_SIDED|95.0|-0.43|-0.05||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.05|-0.43|0.012
70860508|NCT00744471|141207094|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.55|-0.18||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.18|-0.55|<0.001
70860509|NCT00744471|141207094|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.83|-0.45||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.45|-0.83|<0.001
70860510|NCT00744471|141207094|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.6|-0.22||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.22|-0.60|<0.001
70860511|NCT00744471|141207094|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.65|-0.27||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.27|-0.65|<0.001
70860512|NCT00744471|141207094|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.87|-0.5||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.50|-0.87|<0.001
70860513|NCT00744471|141207094|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.76|-0.39||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.39|-0.76|<0.001
70860514|NCT00744471|141207094|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.1||0.022|TWO_SIDED|95.0|-0.43|-0.03||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.03|-0.43|0.022
70860515|NCT00744471|141207094|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.67|-0.27||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.27|-0.67|<0.001
70860516|NCT00744471|141207094|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.65|-0.26||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.26|-0.65|<0.001
70947366|NCT00874497|141395156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.176||||0.457|TWO_SIDED|95.0|-7.98|3.63|||ANCOVA|||Statistical analysis of Right Lower region of the Lung at Week 104.||3.63|-7.98|0.457
70860517|NCT00744471|141207094|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.19||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.19|-0.60|<0.001
70860518|NCT00744471|141207094|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.88|-0.47||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.47|-0.88|<0.001
70860519|NCT00744471|141207094|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.79|-0.39||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.39|-0.79|<0.001
70860520|NCT00744471|141207094|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.53|-0.14||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.14|-0.53|<0.001
70860521|NCT00744471|141207094|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.68|-0.28||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.28|-0.68|<0.001
70860522|NCT00744471|141207094|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.71|-0.32||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.32|-0.71|<0.001
70860523|NCT00744471|141207094|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.1||0.01|TWO_SIDED|95.0|-0.47|-0.06||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.06|-0.47|0.010
70860524|NCT00744471|141207094|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.66|-0.25||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.25|-0.66|<0.001
70947367|NCT00874497|141395156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.167||||0.362|TWO_SIDED|95.0|-6.88|2.54|||ANCOVA|||Statistical analysis of Left Upper region of the Lung at Week 104.||2.54|-6.88|0.362
70947368|NCT00874497|141395156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.225||||0.67|TWO_SIDED|95.0|-6.94|4.48|||ANCOVA|||Statistical analysis of Left Lower region of the Lung at Week 104.||4.48|-6.94|0.670
70947369|NCT00874497|141395156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.218||||0.244|TWO_SIDED|95.0|-5.98|1.55|||ANCOVA|||Statistical analysis of Right Whole region of the Lung at Week 104.||1.55|-5.98|0.244
70860525|NCT00744471|141207094|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.53|-0.13||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.13|-0.53|0.001
70860526|NCT04706416|141207118|SUPERIORITY||Odds Ratio (OR)|0.6||||0.297|TWO_SIDED|95.0|0.26|1.48|||Fisher Exact|||||1.48|0.26|0.297
70860527|NCT04706416|141207118|SUPERIORITY||Odds Ratio (OR)|0.68||||0.541|TWO_SIDED|95.0|0.19|2.3|||Regression, Logistic|||||2.30|0.19|0.541
70860528|NCT04706416|141207119|SUPERIORITY||Odds Ratio (OR)|0.37||||0.039|TWO_SIDED|95.0|0.15|0.91|||Fisher Exact|||||0.91|0.15|0.039
70860529|NCT04706416|141207119|SUPERIORITY||Odds Ratio (OR)|0.34||||0.081|TWO_SIDED|95.0|0.09|1.07|||Regression, Logistic|||||1.07|0.09|0.081
70860530|NCT04706416|141207120|SUPERIORITY||Hodges-Lehmann estimator|0.0||||0.643|TWO_SIDED|95.0|-1.0|3.0|||Wilcoxon (Mann-Whitney)|||||3.0|-1.0|0.643
70860531|NCT04706416|141207120|SUPERIORITY||β-coefficient|-4.27||||0.001|TWO_SIDED|95.0|-5.67|-2.87|||Regression, Linear|||||-2.87|-5.67|0.001
70860532|NCT04706416|141207121|SUPERIORITY||Odds Ratio (OR)|0.53||||0.133|TWO_SIDED|95.0|0.25|1.19|||Fisher Exact|||||1.19|0.25|0.133
70947370|NCT00874497|141395156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.374||||0.574|TWO_SIDED|95.0|-6.23|3.48|||ANCOVA|||Statistical analysis of Left Whole region of the Lung at Week 104.||3.48|-6.23|0.574
70860533|NCT04706416|141207122|SUPERIORITY||Hodges-Lehmann estimator|4.0||||0.092|TWO_SIDED|95.0|-1.0|12.0|||Wilcoxon (Mann-Whitney)|||||12.0|-1.0|0.092
70860534|NCT04706416|141207123|SUPERIORITY||Hodges-Lehmann estimator|0.0||||0.834|TWO_SIDED|95.0|-2.0|2.0|||Wilcoxon (Mann-Whitney)|||||2.0|-2.0|0.834
70860535|NCT04706416|141207124|SUPERIORITY||Odds Ratio (OR)|0.001||||0.149|TWO_SIDED|95.0|0.0|1.52|||Fisher Exact|||||1.52|0|0.149
70860536|NCT04706416|141207125|SUPERIORITY||Odds Ratio (OR)|0.3||||0.015|TWO_SIDED|95.0|0.12|0.8|||Fisher Exact|||||0.80|0.12|0.015
70860537|NCT01539317|141207131|SUPERIORITY_OR_OTHER|||||||0.0149|||||||Wilcoxon (Mann-Whitney)|||Phase II: During Blinded 4 weeks||||0.0149
70860538|NCT01539317|141207131|SUPERIORITY_OR_OTHER|||||||0.412|||||||Wilcoxon (Mann-Whitney)|||Phase III||||0.412
70860539|NCT01539317|141207132|SUPERIORITY_OR_OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Desire||||0.66
70860540|NCT01539317|141207132|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Arousal (S)||||0.11
70860541|NCT01539317|141207132|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Arousal (L)||||0.15
70860542|NCT01539317|141207132|SUPERIORITY_OR_OTHER|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Arousal (C)||||0.28
70947371|NCT00874497|141395158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.97||||0.436|TWO_SIDED|95.0|-1.53|3.47|||ANCOVA|||Statistical analysis of Right Upper region of the Lung at Week 104.||3.47|-1.53|0.436
70860543|NCT01539317|141207132|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Orgasm||||0.07
70860544|NCT01539317|141207132|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Pain||||0.004
70860545|NCT01539317|141207132|SUPERIORITY_OR_OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||Enjoyment||||0.54
70860546|NCT01539317|141207132|SUPERIORITY_OR_OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||Partner||||0.92
70860547|NCT01539317|141207133|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Each of 8 site comparisons had its own P-value and a value of \<0.001 was the difference at the most tender sites|Wilcoxon (Mann-Whitney)|||||||<0.001
70860548|NCT04616027|141207147|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|99.67|||||TWO_SIDED|90.0|70.15|141.6||||||"T2DM Normal Renal Function was test, Healthy and Normal Renal Function was reference."||141.60|70.15|
70860549|NCT04616027|141207147|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|101.34|||||TWO_SIDED|90.0|70.51|145.63||||||"T2DM Mild Renal Impairment was test, T2DM Normal Renal Function was reference."||145.63|70.51|
70860550|NCT04616027|141207147|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|146.56|||||TWO_SIDED|90.0|103.16|208.22||||||"T2DM Moderate Renal Impairment was test, T2DM Normal Renal Function was reference."||208.22|103.16|
70860551|NCT04616027|141207147|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|101.31|||||TWO_SIDED|90.0|71.31|143.92||||||"T2DM Severe Renal Impairment was test, T2DM Normal Renal Function was reference."||143.92|71.31|
70860552|NCT04616027|141207148|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|111.71|||||TWO_SIDED|90.0|79.52|156.93||||||"T2DM Normal Renal Function was test, Healthy and Normal Renal Function was reference."||156.93|79.52|
70860553|NCT04616027|141207148|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|120.31|||||TWO_SIDED|90.0|83.49|173.38||||||"T2DM Mild Renal Impairment was test, T2DM Normal Renal Function was reference."||173.38|83.49|
70860554|NCT04616027|141207148|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|134.18|||||TWO_SIDED|90.0|94.46|190.62||||||"T2DM Moderate Renal Impairment was test, T2DM Normal Renal Function was reference."||190.62|94.46|
70860555|NCT04616027|141207148|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|100.99|||||TWO_SIDED|90.0|71.89|141.87||||||"T2DM Severe Renal Impairment was test, T2DM Normal Renal Function was reference."||141.87|71.89|
70860556|NCT04616027|141207149|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|111.02|||||TWO_SIDED|90.0|79.6|154.86||||||"T2DM Normal Renal Function was test, Healthy and Normal Renal Function was reference."||154.86|79.60|
70860557|NCT04616027|141207149|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|116.7|||||TWO_SIDED|90.0|82.76|164.56||||||"T2DM Mild Renal Impairment was test, T2DM Normal Renal Function was reference."||164.56|82.76|
70860558|NCT04616027|141207149|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|134.68|||||TWO_SIDED|90.0|96.56|187.85||||||"T2DM Moderate Renal Impairment was test, T2DM Normal Renal Function was reference."||187.85|96.56|
70860559|NCT04616027|141207149|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|101.31|||||TWO_SIDED|90.0|72.63|141.3||||||"T2DM Severe Renal Impairment was test, T2DM Normal Renal Function was reference."||141.30|72.63|
70860560|NCT04616027|141207150|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|101.52|||||TWO_SIDED|90.0|88.89|115.94||||||"T2DM Normal Renal Function was test, Healthy and Normal Renal Function was reference."||115.94|88.89|
70860561|NCT04616027|141207150|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|110.17|||||TWO_SIDED|90.0|96.05|126.37||||||"T2DM Mild Renal Impairment was test, T2DM Normal Renal Function was reference."||126.37|96.05|
71132421|NCT02815644|141767794|SUPERIORITY_OR_OTHER||T/R Ratio|82.19|STANDARD_ERROR_OF_MEAN|1.028|||TWO_SIDED|90.0|78.38|86.18|||||Standard Error of the mean is actually geometric Standard Error of the mean|"Relative bioavailability of linagliptin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||86.18|78.38|
71132422|NCT03364309|141767808|SUPERIORITY||Odds Ratio (OR)|99.99|||<|0.0001|TWO_SIDED|95.0|33.57|99.99|||Regression, Logistic|||||99.99|33.57|<0.0001
71132423|NCT03364309|141767808|SUPERIORITY||Odds Ratio (OR)|99.99|||<|0.001|TWO_SIDED|95.0|52.49|99.99|||Regression, Logistic|||||99.99|52.49|<0.001
71132424|NCT03364309|141767809|SUPERIORITY||Odds Ratio (OR)|79.95|||<|0.001|TWO_SIDED|95.0|32.76|99.99|||Regression, Logistic|||||99.99|32.76|<0.001
71132425|NCT03364309|141767809|SUPERIORITY||Odds Ratio (OR)|99.99|||<|0.001|TWO_SIDED|95.0|64.87|99.99|||Regression, Logistic|||||99.99|64.87|<0.001
71132426|NCT03364309|141767811|SUPERIORITY||Odds Ratio (OR)|99.99|||<|0.001|TWO_SIDED|95.0|31.88|99.99|||Regression, Logistic|||||99.99|31.88|<0.001
71132427|NCT03364309|141767811|SUPERIORITY||Odds Ratio (OR)|99.99|||<|0.001|TWO_SIDED|95.0|46.96|99.99|||Regression, Logistic|||||99.99|46.96|<0.001
71132428|NCT03364309|141767813|SUPERIORITY||Odds Ratio (OR)|37.24|||<|0.001|TWO_SIDED|95.0|13.68|99.99|||Regression, Logistic|||||99.99|13.68|<0.001
71132429|NCT03364309|141767813|SUPERIORITY||Odds Ratio (OR)|41.38|||<|0.001|TWO_SIDED|95.0|15.09|99.99|||Regression, Logistic|||||99.99|15.09|<0.001
71132430|NCT03364309|141767814|SUPERIORITY||LSMean Difference|-9.52|STANDARD_ERROR_OF_MEAN|0.604|<|0.001|TWO_SIDED|95.0|-10.71|-8.33|||Mixed Models Analysis|||||-8.33|-10.71|<0.001
71132431|NCT03364309|141767814|SUPERIORITY||LSMean Difference|-9.78|STANDARD_ERROR_OF_MEAN|0.603|<|0.001|TWO_SIDED|95.0|-10.96|-8.59|||Mixed Models Analysis|||||-8.59|-10.96|<0.001
71132432|NCT03364309|141767815|SUPERIORITY||LSMean Difference|-10.09|STANDARD_ERROR_OF_MEAN|1.673|<|0.001|TWO_SIDED|95.0|-13.38|-6.79|||Mixed Models Analysis|||||-6.79|-13.38|<0.001
71132433|NCT03364309|141767815|SUPERIORITY||LSMean Difference|-8.81|STANDARD_ERROR_OF_MEAN|1.677|<|0.001|TWO_SIDED|95.0|-12.11|-5.51|||Mixed Models Analysis|||||-5.51|-12.11|<0.001
70860562|NCT04616027|141207150|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|120.63|||||TWO_SIDED|90.0|105.63|137.77||||||"T2DM Moderate Renal Impairment was test, T2DM Normal Renal Function was reference."||137.77|105.63|
71132434|NCT03364309|141767816|SUPERIORITY||LSMean Difference|-34.96|STANDARD_ERROR_OF_MEAN|2.023|<|0.001|TWO_SIDED|95.0|-38.94|-30.98|||Mixed Models Analysis|||||-30.98|-38.94|<0.001
71132435|NCT03364309|141767816|SUPERIORITY||LSMean Difference|-36.34|STANDARD_ERROR_OF_MEAN|2.018|<|0.001|TWO_SIDED|95.0|-40.3|-32.37|||Mixed Models Analysis|||||-32.37|-40.30|<0.001
71132436|NCT03364309|141767817|SUPERIORITY||LSMean Difference|-16.74|STANDARD_ERROR_OF_MEAN|0.957|<|0.001|TWO_SIDED|95.0|-18.62|-14.86|||Mixed Models Analysis|||||-14.86|-18.62|<0.001
71132437|NCT03364309|141767817|SUPERIORITY||LSMean Difference|-17.93|STANDARD_ERROR_OF_MEAN|0.954|<|0.001|TWO_SIDED|95.0|-19.8|-16.05|||Mixed Models Analysis|||||-16.05|-19.80|<0.001
71132438|NCT03364309|141767818|SUPERIORITY||LSMean Difference|6.228|STANDARD_ERROR_OF_MEAN|0.6681|<|0.001|TWO_SIDED|95.0|4.915|7.541|||Mixed Models Analysis|||||7.541|4.915|<0.001
71132439|NCT03364309|141767818|SUPERIORITY||LSMean Difference|6.536|STANDARD_ERROR_OF_MEAN|0.6668|<|0.001|TWO_SIDED|95.0|5.225|7.847|||Mixed Models Analysis|||||7.847|5.225|<0.001
71132440|NCT03364309|141767819|SUPERIORITY||LSMean Difference|5.193|STANDARD_ERROR_OF_MEAN|0.9489|<|0.001|TWO_SIDED|95.0|3.328|7.058|||Mixed Models Analysis|||||7.058|3.328|<0.001
71132441|NCT03364309|141767819|SUPERIORITY||LSMean Difference|5.362|STANDARD_ERROR_OF_MEAN|0.946|<|0.001|TWO_SIDED|95.0|3.503|7.222|||Mixed Models Analysis|||||7.222|3.503|<0.001
71132442|NCT03364309|141767820|SUPERIORITY||LSMean Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-2.9|-2.4|||Mixed Models Analysis|||||-2.4|-2.9|<0.001
71132443|NCT03364309|141767820|SUPERIORITY||LSMean Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-2.9|-2.3|||Mixed Models Analysis|||||-2.3|-2.9|<0.001
71132444|NCT03364309|141767821|SUPERIORITY||LSMean Difference|-3.35|STANDARD_ERROR_OF_MEAN|1.11||0.003|TWO_SIDED|95.0|-5.56|-1.15|||Mixed Models Analysis|||||-1.15|-5.56|0.003
71132445|NCT03364309|141767821|SUPERIORITY||LSMean Difference|-4.79|STANDARD_ERROR_OF_MEAN|1.064|<|0.001|TWO_SIDED|95.0|-6.9|-2.67|||Mixed Models Analysis|||||-2.67|-6.90|<0.001
71132446|NCT03364309|141767822|SUPERIORITY||LSMean Difference|-27.4|STANDARD_ERROR_OF_MEAN|11.07||0.022|TWO_SIDED|95.0|-50.5|-4.3|||Mixed Models Analysis|||||-4.3|-50.5|0.022
71132447|NCT03364309|141767822|SUPERIORITY||LSMean Difference|-25.2|STANDARD_ERROR_OF_MEAN|10.87||0.031|TWO_SIDED|95.0|-47.8|-2.5|||Mixed Models Analysis|||||-2.5|-47.8|0.031
71132448|NCT03304873|141767824|SUPERIORITY|||||||0.0004|||||||t-test, 1 sided|||||||0.0004
71132449|NCT03304873|141767825|SUPERIORITY|||||||0.99|||||||t-test, 1 sided|||||||0.99
71132450|NCT01052077|141767836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18||||0.1416|TWO_SIDED|95.0|-2.75|0.39||ANCOVA model, with treatment and study center as main effects and Week 8 value as convariate, is used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||0.39|-2.75|0.1416
71132451|NCT01052077|141767837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.3778|TWO_SIDED|95.0|-0.69|0.26||ANCOVA model, with treatment and study center as main effects and Week 8 value as covariate, is used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||0.26|-0.69|0.3778
71132452|NCT01052077|141767838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31||||0.0162|TWO_SIDED|95.0|-2.38|-0.24||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 9||-0.24|-2.38|0.0162
70860563|NCT04616027|141207150|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|127.06|||||TWO_SIDED|90.0|111.26|145.12||||||"T2DM Severe Renal Impairment was test, T2DM Normal Renal Function was reference."||145.12|111.26|
70860564|NCT03737851|141207165|OTHER|a statistical test was not performed|Odds Ratio (OR)|1.202|||||TWO_SIDED|95.0|0.559|2.584||||||Logistic regression model for EDSS+ includes baseline values for EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant, 9-Hole Peg Test-nondominant, and treatment as a main effect. Subjects with missing values were imputed as non-responders.||2.584|0.559|
70860565|NCT03737851|141207165|OTHER|a statistical test was not performed|Odds Ratio (OR)|0.615|||||TWO_SIDED|95.0|0.266|1.421||||||Logistic regression model for EDSS+ includes baseline values for EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant, 9-Hole Peg Test-nondominant, and treatment as a main effect. Subjects with missing values were imputed as non-responders.||1.421|0.266|
70860566|NCT01436162|141207209|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.92||0.583|TWO_SIDED|95.0|-2.3|1.3|||Mixed-effects Model for Repeat Measures|||||1.3|-2.3|0.583
70860567|NCT01436162|141207210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.65||0.354|TWO_SIDED|95.0|-1.9|0.7|||Mixed-effects Model for Repeat Measures|||||0.7|-1.9|0.354
70860568|NCT05032859|141207223|SUPERIORITY||Risk Ratio, log|2.27|||<|0.0001|TWO_SIDED|95.0|1.54|3.32|||Cochran-Mantel-Haenszel|Stratified by Baseline vIGA-AD Score and Age Group|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|H0: The proportion of subjects who achieve a vIGA-AD score of clear (0) or almost clear (1) and at least a 2-grade reduction from Baseline at Week 8 is equal between tapinarof cream, 1% and vehicle cream; H1: The proportion of subjects who achieve a vIGA-AD score of clear (0) or almost clear (1) and at least a 2-grade reduction from Baseline at Week 8 is different between the tapinarof cream, 1% and vehicle cream.||3.32|1.54|<0.0001
70860569|NCT05032859|141207224|SUPERIORITY||Risk Ratio, log|2.14|||<|0.0001|TWO_SIDED|95.0|1.53|3.0|||Cochran-Mantel-Haenszel|Stratified by vIGA-AD score at Baseline (vIGA-AD scores of 3 or 4) and age group (2-6 yrs, 7-11 yrs, 12-17 yrs, 18+ yrs)|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|||3.00|1.53|<0.0001
70860570|NCT05032859|141207225|SUPERIORITY||Least squares mean difference|-6.6|STANDARD_ERROR_OF_MEAN|0.803|<|0.0001|TWO_SIDED|95.0|-8.17|-5.02|||ANCOVA|age\*vIGA cohort and treatment as categorical covariates, and baseline %BSA as a continuous covariate||||-5.02|-8.17|<0.0001
70860571|NCT05032859|141207226|SUPERIORITY||Risk Ratio, log|2.34||||0.0013|TWO_SIDED|95.0|1.39|3.94|||Cochran-Mantel-Haenszel|Stratified by Baseline vIGA-AD Score and Age Group|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.||Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|3.94|1.39|0.0013
70860572|NCT05032859|141207227|SUPERIORITY||Risk Ratio, log|2.17||||0.0015|TWO_SIDED|95.0|1.34|3.5|||Cochran-Mantel-Haenszel|Stratified by Baseline vIGA-AD Score and Age Group|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|||3.50|1.34|0.0015
70860573|NCT01535664|141207228|SUPERIORITY_OR_OTHER||Difference in least square means|4.04|STANDARD_ERROR_OF_MEAN|1.51||0.015|TWO_SIDED|95.0|0.87|7.2||A step-down procedure using the primary statistical analysis was followed. If the p-value for the overall gait was less than 0.05, then overall balance was tested in the same manner. Otherwise, the testing procedure was stopped.|Mixed Models Analysis|P-value is based on a mixed model ANOVA with a fixed effect for treatment.||The co-primary efficacy variable was overall gait. This novel composite score was created from standardized individual NeuroCom test results (Z-scores). Overall gait was the average of WA, TW, and SQT; a higher score is indicative of better performance.||7.20|0.87|0.015
70860574|NCT01535664|141207229|SUPERIORITY_OR_OTHER||Difference in least square means|1.7|STANDARD_ERROR_OF_MEAN|0.5||0.003|TWO_SIDED|95.0|0.7|2.8|||Mixed Models Analysis|P-value is based on a mixed model ANOVA with a fixed effect for treatment||||2.8|0.7|0.003
70860575|NCT01535664|141207230|SUPERIORITY_OR_OTHER||Difference in least square means|7.729|STANDARD_ERROR_OF_MEAN|2.495||0.006|TWO_SIDED|95.0|2.507|12.95|||Mixed Models Analysis|P-value is based on a mixed model ANOVA with a fixed effect for treatment||||12.950|2.507|0.006
70860576|NCT01535664|141207231|SUPERIORITY_OR_OTHER||Difference in least square means|0.36|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|0.19|0.54|||Mixed Models Analysis|P-value is based on a mixed model ANOVA with a fixed effect for treatment||||0.54|0.19|<.001
71132453|NCT01052077|141767838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.0031|TWO_SIDED|95.0|-3.15|-0.65||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 10||-0.65|-3.15|0.0031
70860577|NCT01535664|141207232|SUPERIORITY_OR_OTHER||Difference in least square means|-2.38|STANDARD_ERROR_OF_MEAN|2.97||0.434|TWO_SIDED|95.0|-8.6|3.84||A step-down procedure using the primary statistical analysis was followed. If the p-value for the overall gait was less than 0.05, then overall balance was tested in the same manner. Otherwise, the testing procedure was stopped.|Mixed Models Analysis|P-value is based on a mixed model ANOVA with a fixed effect for treatment||The co-primary efficacy variable was overall balance. This novel composite score was created from standardized individual NeuroCom test results (Z-scores). Overall balance was a weighted average of SOT, LOS, and ADT.||3.84|-8.60|0.434
70860578|NCT00395538|141207255|OTHER|A contrast statement within the mixed models analysis tested for differences in the cn.BV/TV between the baseline and the year 1 biopsy.||||||0.015||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.BV/TV at biopsy baseline, year 1, 2 \& 4 combined as the dependent variable; biopsy year as the independent variable, covariate for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2. No bone biopsy baseline covariate was included because it would over-parameterize the model.||||0.015
70860579|NCT00395538|141207255|OTHER|A contrast statement within the mixed models analysis tested for differences in the cn.BV/TV between the baseline and the years 2 and 4 (combined) biopsy.||||||0.002||||||No adjustments were made for multiple comparisons, because the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.BV/TV at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2. No bone biopsy baseline covariate included because it would over-parameterize the model.||||0.002
70872089|NCT02155608|141229489|SUPERIORITY|||||||0.42||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .66, df = 1/31.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.42
70947372|NCT00874497|141395158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.31||||0.067|TWO_SIDED|95.0|-0.17|4.79|||ANCOVA|||Statistical analysis of Right Middle region of the Lung at Week 104.||4.79|-0.17|0.067
70947373|NCT00874497|141395158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.97||||0.163|TWO_SIDED|95.0|-0.83|4.77|||ANCOVA|||Statistical analysis of Right Lower region of the Lung at Week 104.||4.77|-0.83|0.163
70947374|NCT00874497|141395158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.27||||0.102|TWO_SIDED|95.0|-0.48|5.02|||ANCOVA|||Statistical analysis of Left Upper region of the Lung at Week 104.||5.02|-0.48|0.102
70860580|NCT00395538|141207255|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the cn.BV/TV between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.649||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Cn.BV/TV change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Cn.BV/TV, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).||||0.649
70860581|NCT00395538|141207256|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.N between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ct.Po.N values for both their baseline and year 1 biopsies.||||||0.371||||||No adjustments were made for multiple comparisons, because the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Po.N at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.371
70860582|NCT00395538|141207256|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.N between the baseline and the years 2 and 4 (combined) biopsy.||||||0.129||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Ct.Po.N change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Ct.Po.N, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).||||0.129
70860583|NCT00395538|141207256|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.N between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.538||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Po.N at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.538
70860584|NCT00395538|141207257|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.BFR/BS between the baseline and the year 1 biopsy.||||||0.009||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|A baseline covariate not added to model since it would over-parameterize the model.||Mixed models analysis: Cn.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.009
70860585|NCT00395538|141207257|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.BFR/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
70860586|NCT00395538|141207257|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Cn.BFR/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.374||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.374
70872090|NCT02155608|141229490|SUPERIORITY|||||||0.29||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = 0.29, df = 1/129.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.29
70872091|NCT02155608|141229490|SUPERIORITY|||||||0.02||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 5.83, df = 1/129.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.02
70947375|NCT00874497|141395158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.11||||0.162|TWO_SIDED|95.0|-0.89|5.12|||ANCOVA|||Statistical analysis of Left Lower region of the Lung at Week 104.||5.12|-0.89|0.162
70860587|NCT00395538|141207258|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.MS/BS between the baseline and the year 1 biopsy.||||||0.002||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.002
70860588|NCT00395538|141207258|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.MS/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
70860589|NCT00395538|141207258|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Cn.MS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.168||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.168
70860590|NCT00395538|141207259|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.BFR/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.BFR/BS values for both their baseline and year 1 biopsies.||||||0.083||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.083
70860591|NCT00395538|141207259|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.BFR/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
70860592|NCT00395538|141207259|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Ec.BFR/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.164||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.164
70860593|NCT00395538|141207260|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.MS/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.MS/BS values for both their baseline and year 1 biopsies.||||||0.031||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.031
70947376|NCT00874497|141395158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.78||||0.16|TWO_SIDED|95.0|-0.73|4.29|||ANCOVA|||Statistical analysis of Right Whole region of the Lung at Week 104.||4.29|-0.73|0.160
70947377|NCT00874497|141395158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.08||||0.122|TWO_SIDED|95.0|-0.58|4.75|||ANCOVA|||Statistical analysis of Left Whole region of the Lung at Week 104.||4.75|-0.58|0.122
70947378|NCT00874497|141395158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.05||||0.106|TWO_SIDED|95.0|-0.46|4.56|||ANCOVA|||Statistical analysis of Whole Lung region of the Lung at Week 104.||4.56|-0.46|0.106
70947379|NCT00874497|141395159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.423||||0.469|TWO_SIDED|95.0|-5.32|2.48|||ANCOVA|||LS Mean Difference between Tetomilast and Placebo at Week 104.||2.48|-5.32|0.469
70860594|NCT00395538|141207260|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.MS/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
70860595|NCT00395538|141207260|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Ec.MS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.178||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.178
70860596|NCT00395538|141207261|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.BFR/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.BFR/BS values for both their baseline and year 1 biopsies.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
70860597|NCT00395538|141207261|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.BFR/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.022||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.022
70860598|NCT00395538|141207261|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Ic.BFR/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.172||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.172
70860599|NCT00395538|141207262|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.MS/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.MS/BS values for both their baseline and year 1 biopsies.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
70860600|NCT00395538|141207262|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.MS/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.018||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.018
70872092|NCT02155608|141229490|SUPERIORITY|||||||0.31||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 1.03, df = 1/129.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.31
70872093|NCT02155608|141229490|SUPERIORITY|||||||0.69||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .16, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.69
70947380|NCT00874497|141395160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07||||0.519|TWO_SIDED|95.0|-4.42|2.27|||ANCOVA|||Statistical analysis of right upper region of the lung at Week 104.||2.27|-4.42|0.519
70860601|NCT00395538|141207262|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Ic.MS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.155||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.155
70860602|NCT00395538|141207263|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.Th between the baseline and the year 1 biopsy.||||||0.72||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.720
70860603|NCT00395538|141207263|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.Th between the baseline and the years 2 and 4 (combined) biopsy.||||||0.944||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.944
70860604|NCT00395538|141207263|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.Th between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.73||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.730
70860605|NCT00395538|141207264|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.N between the baseline and the year 1 biopsy.||||||0.019||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Tb.N change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Tb.N, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).||||0.019
70860606|NCT00395538|141207264|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.N between the baseline and the years 2 and 4 (combined) biopsy.||||||0.017||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Tb.N change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Tb.N, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).||||0.017
70860607|NCT00395538|141207264|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.N between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.843||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Tb.N change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Tb.N, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).||||0.843
70872094|NCT02155608|141229490|SUPERIORITY|||||||0.33||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = .98, df = 1/54.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.33
70947381|NCT00874497|141395160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05||||0.463|TWO_SIDED|95.0|-3.92|1.82|||ANCOVA|||Statistical analysis of right middle region of the lung at Week 104.||1.82|-3.92|0.463
70947382|NCT00874497|141395160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.598|TWO_SIDED|95.0|-6.74|3.94|||ANCOVA|||Statistical analysis of right lower region of the lung at Week 104.||3.94|-6.74|0.598
70947383|NCT00874497|141395160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.94||||0.142|TWO_SIDED|95.0|-6.92|1.03|||ANCOVA|||Statistical analysis of left upper region of the lung at Week 104.||1.03|-6.92|0.142
70947384|NCT00874497|141395160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.757|TWO_SIDED|95.0|-6.26|4.59|||ANCOVA|||Statistical analysis of left lower region of the lung at Week 104.||4.59|-6.26|0.757
70860608|NCT00395538|141207265|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.Sp between the baseline and the year 1 biopsy.||||||0.013||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Sp at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.013
70860609|NCT00395538|141207265|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.Sp between the baseline and the years 2 and 4 (combined) biopsy.||||||0.025||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Sp at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.025
70860610|NCT00395538|141207265|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.Sp between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.608||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Sp at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.608
70947385|NCT00874497|141395160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.27||||0.5|TWO_SIDED|95.0|-5.03|2.5|||ANCOVA|||Statistical analysis of right whole region of the lung at Week 104.||2.50|-5.03|0.500
70947386|NCT00874497|141395160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93||||0.353|TWO_SIDED|95.0|-6.09|2.23|||ANCOVA|||Statistical analysis of left whole region of the lung at Week 104.||2.23|-6.09|0.353
70947387|NCT00874497|141395160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.52||||0.438|TWO_SIDED|95.0|-5.43|2.4|||ANCOVA|||Statistical analysis of whole region of the lung at Week 104.||2.40|-5.43|0.438
70947388|NCT00874497|141395161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|351487.0||||0.22|TWO_SIDED|95.0|-219976.0|922951.0|||ANCOVA|||Statistical analysis of right upper region of the lung at Week 104.||922951|-219976|0.220
70947389|NCT00874497|141395161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|103036.0||||0.146|TWO_SIDED|95.0|-37651.0|243723.0|||ANCOVA|||Statistical analysis of right middle region of the lung at Week 104||243723|-37651|0.146
70947390|NCT00874497|141395161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|247358.0||||0.322|TWO_SIDED|95.0|-252728.0|747444.0|||ANCOVA|||Statistical analysis of right lower region of the lung at Week 104||747444|-252728|0.322
70947391|NCT00874497|141395161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|362384.0||||0.141|TWO_SIDED|95.0|-126518.0|851286.0|||ANCOVA|||Statistical analysis of left upper region of the lung at Week 104.||851286|-126518|0.141
70947392|NCT00874497|141395161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|294202.0||||0.325|TWO_SIDED|95.0|-303329.0|891733.0|||ANCOVA|||Statistical analysis of left lower region of the lung at Week 104.||891733|-303329|0.325
70947393|NCT00874497|141395161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|575882.0||||0.258|TWO_SIDED|95.0|-439692.0|1591457.0|||ANCOVA|||Statistical analysis of right whole region of the lung at Week 104.||1591457|-439692|0.258
70947394|NCT00874497|141395161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|589373.0||||0.247|TWO_SIDED|95.0|-426928.0|1605673.0|||ANCOVA|||Statistical analysis of left whole region of the lung at Week 104.||1605673|-426928|0.247
70947395|NCT00874497|141395161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1156318.0||||0.251|TWO_SIDED|95.0|-855009.0|3167645.0|||ANCOVA|||Statistical analysis of whole lung region of the lung at Week 104.||3167645|-855009|0.251
70947396|NCT00874497|141395162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|77.9||||0.181|TWO_SIDED|95.0|-38.0|193.8|||ANCOVA|||Statistical analysis of right upper lung region (RV) at Week 104.||193.8|-38.0|0.181
70947397|NCT00874497|141395162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9||||0.781|TWO_SIDED|95.0|-48.8|36.9|||ANCOVA|||Statistical analysis of right middle lung region (RV) at Week 104.||36.9|-48.8|0.781
70947398|NCT00874497|141395162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.7||||0.445|TWO_SIDED|95.0|-77.8|173.2|||ANCOVA|||Statistical analysis of right lower lung region (RV) at Week 104.||173.2|-77.8|0.445
70947399|NCT00874497|141395162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|62.6||||0.259|TWO_SIDED|95.0|-48.1|173.2|||ANCOVA|||Statistical analysis of left upper lung region (RV) at Week 104.||173.2|-48.1|0.259
70947400|NCT00874497|141395162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.0||||0.639|TWO_SIDED|95.0|-105.6|169.6|||ANCOVA|||Statistical analysis of left lower lung region (RV) at Week 104.||169.6|-105.6|0.639
70947401|NCT00874497|141395162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|102.3||||0.408|TWO_SIDED|95.0|-145.9|350.5|||ANCOVA|||Statistical analysis of right whole lung region (RV) at Week 104.||350.5|-145.9|0.408
70947402|NCT00874497|141395162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|85.2||||0.445|TWO_SIDED|95.0|-138.8|309.2|||ANCOVA|||Statistical analysis of left whole lung region (RV) at Week 104.||309.2|-138.8|0.445
70947403|NCT00874497|141395162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|187.6||||0.421|TWO_SIDED|95.0|-279.6|654.8|||ANCOVA|||Statistical analysis of whole lung region (RV) at Week 104.||654.8|-279.6|0.421
70947404|NCT00874497|141395162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.7||||0.353|TWO_SIDED|95.0|-58.5|159.9|||ANCOVA|||Statistical analysis of right upper lung region (TLC) at Week 104.||159.9|-58.5|0.353
70947405|NCT00874497|141395162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.9||||0.66|TWO_SIDED|95.0|-35.3|55.0|||ANCOVA|||Statistical analysis of right middle lung region (TLC) at Week 104.||55.0|-35.3|0.660
70860611|NCT00395538|141207266|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Th between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ct.Th values for both their baseline and year 1 biopsies.||||||0.043||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.043
70860612|NCT00395538|141207266|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Th between the baseline and the years 2 and 4 (combined) biopsy.||||||0.334||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.334
70860613|NCT00395538|141207266|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Th between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.269||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Ct.Th change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Ct.Th, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).||||0.269
70860614|NCT00395538|141207267|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Ar between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ct.Ar values for both their baseline and year 1 biopsies.||||||0.358||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.358
70860615|NCT00395538|141207267|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Ar between the baseline and the years 2 and 4 (combined) biopsy.||||||0.76||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.760
70860616|NCT00395538|141207267|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Ar between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.57||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.570
70860617|NCT00395538|141207268|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.Ar between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ct.Po.Ar values for both their baseline and year 1 biopsies.||||||0.166||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Po.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.166
70860618|NCT00395538|141207268|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.Ar between the baseline and the years 2 and 4 (combined) biopsy.||||||0.895||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Po.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.895
70860619|NCT00395538|141207268|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.Ar between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.282||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Po.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.282
70860620|NCT00395538|141207269|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.O.Th between the baseline and the year 1 biopsy.||||||0.003||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.003
70860621|NCT00395538|141207269|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.O.Th between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
70860622|NCT00395538|141207269|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.O.Th between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.68||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.680
70860623|NCT00395538|141207270|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.MAR between the baseline and the year 1 biopsy.||||||0.006||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.006
70860624|NCT00395538|141207270|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.MAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.004||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.004
70860625|NCT00395538|141207270|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.MAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.904||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.904
70860626|NCT00395538|141207271|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.OS/BS between the baseline and the year 1 biopsy.||||||0.002||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.002
70947406|NCT00874497|141395162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.7||||0.859|TWO_SIDED|95.0|-110.7|132.1|||ANCOVA|||Statistical analysis of right lower lung region (TLC) at Week 104.||132.1|-110.7|0.859
71132454|NCT01052077|141767838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.01||||0.0061|TWO_SIDED|95.0|-3.44|-0.58||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 11||-0.58|-3.44|0.0061
71132455|NCT01052077|141767838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.21||||0.0038|TWO_SIDED|95.0|-3.69|-0.72||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 12||-0.72|-3.69|0.0038
71132456|NCT01052077|141767838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.82||||0.0174|TWO_SIDED|95.0|-3.32|-0.32||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 13||-0.32|-3.32|0.0174
71132457|NCT01052077|141767838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18||||0.1416|TWO_SIDED|95.0|-2.75|0.39||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||0.39|-2.75|0.1416
71132458|NCT01052077|141767839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.1481|TWO_SIDED|95.0|-0.21|0.03||ANCOVA model, with treatment and study center as main effects and Week 8 value as covariate, is used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 9||0.03|-0.21|0.1481
71132459|NCT01052077|141767839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.0691|TWO_SIDED|95.0|-0.28|0.01||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 10||0.01|-0.28|0.0691
71132460|NCT01052077|141767839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.0457|TWO_SIDED|95.0|-0.35|0.0||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 11||-0.00|-0.35|0.0457
71132461|NCT01052077|141767839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.0061|TWO_SIDED|95.0|-0.45|-0.08||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 12||-0.08|-0.45|0.0061
71132462|NCT01052077|141767839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.0572|TWO_SIDED|95.0|-0.38|0.01||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 13||0.01|-0.38|0.0572
71132463|NCT01052077|141767839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3318|TWO_SIDED|95.0|-0.29|0.1||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||0.10|-0.29|0.3318
71132464|NCT01052077|141767840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.6272|TWO_SIDED|95.0|-1.02|1.69||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 9||1.69|-1.02|0.6272
71132465|NCT01052077|141767840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.9697|TWO_SIDED|95.0|-1.48|1.54||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo||Week 10||1.54|-1.48|0.9697
71132466|NCT01052077|141767840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.749|TWO_SIDED|95.0|-2.0|1.44||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 11||1.44|-2.00|0.7490
70947407|NCT00874497|141395162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.5||||0.253|TWO_SIDED|95.0|-38.4|141.4|||ANCOVA|||Statistical analysis of left upper lung region (TLC)at Week 104.||141.4|-38.4|0.253
70947408|NCT00874497|141395162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.3||||0.754|TWO_SIDED|95.0|-126.0|172.6|||ANCOVA|||Statistical analysis of left lower lung region (TLC) at Week 104.||172.6|-126.0|0.754
70947409|NCT00874497|141395162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|62.2||||0.546|TWO_SIDED|95.0|-145.1|269.5|||ANCOVA|||Statistical analysis of right whole lung region (TLC) at Week 104.||269.5|-145.1|0.546
70947410|NCT00874497|141395162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|64.9||||0.554|TWO_SIDED|95.0|-155.5|285.3|||ANCOVA|||Statistical analysis of left whole lung region (TLC) at Week 104.||285.3|-155.5|0.554
70947411|NCT00874497|141395162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|132.2||||0.524|TWO_SIDED|95.0|-284.9|549.4|||ANCOVA|||Statistical analysis of whole lung region (TLC) at Week 104.||549.4|-284.9|0.524
70947412|NCT00874497|141395163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.5843|TWO_SIDED|95.0|-0.07|0.04|||ANCOVA|||||0.04|-0.07|0.5843
70947413|NCT00874497|141395164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.249||||0.1252|TWO_SIDED|95.0|-0.073|0.571|||ANCOVA|||||0.571|-0.073|0.1252
71132467|NCT01052077|141767840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.9459|TWO_SIDED|95.0|-1.94|1.81||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 12||1.81|-1.94|0.9459
71132468|NCT01052077|141767840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9893|TWO_SIDED|95.0|-1.91|1.88||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 13||1.88|-1.91|0.9893
71132469|NCT01052077|141767840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.8918|TWO_SIDED|95.0|-1.89|2.17||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||2.17|-1.89|0.8918
71132470|NCT01052077|141767841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.3247|TWO_SIDED|95.0|-1.71|0.57||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||0.57|-1.71|0.3247
71132471|NCT01052077|141767842|SUPERIORITY_OR_OTHER|||||||0.5616||||||Cohran-Mantel-Haenszel (CMH) row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean: brexpiprazole - placebo.||Week 9||||0.5616
71132472|NCT01052077|141767842|SUPERIORITY_OR_OTHER|||||||0.19||||||CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 10||||0.1900
71132473|NCT01052077|141767842|SUPERIORITY_OR_OTHER|||||||0.0501||||||CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 11||||0.0501
70947414|NCT00874497|141395165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1835||||0.4661|TWO_SIDED|95.0|-0.6892|0.3221|||ANCOVA|||||0.3221|-0.6892|0.4661
70947415|NCT00874497|141395166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.134|TWO_SIDED|95.0|-0.19|1.4|||ANCOVA|||||1.40|-0.19|0.134
71132474|NCT01052077|141767842|SUPERIORITY_OR_OTHER|||||||0.0137||||||CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 12||||0.0137
70947416|NCT00874497|141395167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.074|TWO_SIDED|95.0|-1.5|0.07|||ANCOVA|||Statistical analysis for sRaw||0.07|-1.50|0.074
70947417|NCT00874497|141395167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.155|TWO_SIDED|95.0|-0.09|0.52|||ANCOVA|||Statistical analysis for sGaw||0.52|-0.09|0.155
70947418|NCT00874497|141395168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.845|TWO_SIDED|95.0|-0.77|0.64|||ANCOVA|||Statistical analysis for mean prior daily breath symptoms||0.64|-0.77|0.845
70947419|NCT00874497|141395168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.549|TWO_SIDED|95.0|-0.52|0.94|||ANCOVA|||Statistical analysis for mean prior daily cough symptoms||0.94|-0.52|0.549
70947420|NCT00874497|141395168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.717|TWO_SIDED|95.0|-0.93|0.65|||ANCOVA|||Statistical analysis for mean prior daily sputum symptoms||0.65|-0.93|0.717
70947421|NCT00874497|141395170|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Statistical analysis for level I (self management) at week 104.||||1.000
70947422|NCT00874497|141395170|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Statistical analysis for level II (physician visit) at week 104.||||1.0000
70947423|NCT00874497|141395170|SUPERIORITY_OR_OTHER|||||||0.5092|||||||Fisher Exact|||Statistical analysis for level III (hospital visit) at week 104.||||0.5092
70947424|NCT00874497|141395171|SUPERIORITY_OR_OTHER|||||||0.63||||||Fisher's Exact test was used to determine whether the tetomilast and placebo groups differ in the proportion of participants who experienced Level 2 or higher COPD exacerbations during the study.|Fisher Exact|||Statistical analysis at Week 104||||0.630
70947425|NCT00665223|141395188|SUPERIORITY|This analysis compared ACR16 45 mg vs. placebo during the randomization phase.|Mean Difference (Final Values)|-0.36||||0.456|TWO_SIDED|97.5|-1.44|0.72|||ANCOVA|||The analysis of covariance (ANCOVA) main effects model included a term for treatment and covariates for baseline mMS, gender, and use of antipsychotic medication.||0.72|-1.44|0.456
71132475|NCT01052077|141767842|SUPERIORITY_OR_OTHER|||||||0.0711||||||CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 13||||0.0711
70860627|NCT00395538|141207271|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.OS/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
70872095|NCT02155608|141229490|SUPERIORITY|||||||0.35||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .88, df = 1/54.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.35
70860628|NCT00395538|141207271|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.OS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.01||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.010
70860629|NCT00395538|141207272|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.ES/BS between the baseline and the year 1 biopsy.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
70860630|NCT00395538|141207272|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.ES/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
70872096|NCT02155608|141229491|SUPERIORITY|||||||0.21||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = 1.62, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.21
70872097|NCT02155608|141229491|SUPERIORITY|||||||0.02||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 5.18, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.02
70947426|NCT00665223|141395188|SUPERIORITY|This analysis compared ACR16 90 mg vs. placebo during the randomization phase.|Mean Difference (Final Values)|-0.99||||0.042|TWO_SIDED|97.5|-2.08|0.1|||ANCOVA|||The analysis of covariance (ANCOVA) main effects model included a term for treatment and covariates for baseline mMS, gender, and use of antipsychotic medication.||0.10|-2.08|0.042
71132476|NCT01052077|141767842|SUPERIORITY_OR_OTHER|||||||0.3438||||||CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||||0.3438
71132477|NCT01052077|141767843|SUPERIORITY_OR_OTHER||Ratio of Response rate|2.79||||0.0679|TWO_SIDED|95.0|0.88|8.81|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 9||8.81|0.88|0.0679
71132478|NCT01052077|141767843|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.78||||0.036|TWO_SIDED|95.0|1.01|3.14|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 10||3.14|1.01|0.0360
71132479|NCT01052077|141767843|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.53||||0.0521|TWO_SIDED|95.0|0.99|2.35|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 11||2.35|0.99|0.0521
71132480|NCT01052077|141767843|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.93||||0.0008|TWO_SIDED|95.0|1.31|2.86|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 12||2.86|1.31|0.0008
71132481|NCT01052077|141767843|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.64||||0.0074|TWO_SIDED|95.0|1.14|2.38|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 13||2.38|1.14|0.0074
71132482|NCT01052077|141767843|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.47||||0.0339|TWO_SIDED|95.0|1.03|2.08|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 14||2.08|1.03|0.0339
71132483|NCT01052077|141767844|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|2.27||||0.2404|TWO_SIDED|95.0|0.55|9.3|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 9||9.30|0.55|0.2404
71132484|NCT01052077|141767844|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|2.04||||0.0983|TWO_SIDED|95.0|0.83|4.98|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 10||4.98|0.83|0.0983
71132485|NCT01052077|141767844|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.67||||0.0496|TWO_SIDED|95.0|0.99|2.82|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 11||2.82|0.99|0.0496
71132486|NCT01052077|141767844|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|2.12||||0.0019|TWO_SIDED|95.0|1.31|3.46|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 12||3.46|1.31|0.0019
71132487|NCT01052077|141767844|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.77||||0.0068|TWO_SIDED|95.0|1.17|2.67|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 13||2.67|1.17|0.0068
71132488|NCT01052077|141767844|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.71||||0.0089|TWO_SIDED|95.0|1.14|2.57||The CMH general association test controlling for trial center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||2.57|1.14|0.0089
71132489|NCT01052077|141767845|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.23||||0.4605|TWO_SIDED|95.0|0.7|2.18|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center.||Week 9||2.18|0.70|0.4605
71132490|NCT01052077|141767845|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.2||||0.3267|TWO_SIDED|95.0|0.83|1.72|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center.||Week 10||1.72|0.83|0.3267
70860631|NCT00395538|141207272|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.ES/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.02||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.020
70860632|NCT00395538|141207273|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.AjAR between the baseline and the year 1 biopsy.||||||0.002||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.002
70860633|NCT00395538|141207273|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.AjAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.022||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.022
70860634|NCT00395538|141207273|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.AjAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.228||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.228
71132491|NCT01052077|141767845|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.37||||0.023|TWO_SIDED|95.0|1.05|1.8|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center.||Week 11||1.80|1.05|0.0230
71132492|NCT01052077|141767845|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.36||||0.0105|TWO_SIDED|95.0|1.08|1.71|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center.||Week 12||1.71|1.08|0.0105
71132493|NCT01052077|141767845|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.26||||0.0417|TWO_SIDED|95.0|1.01|1.58|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center.||Week 13||1.58|1.01|0.0417
70860635|NCT00395538|141207274|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.O.Th between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.O.Th values for both their baseline and year 1 biopsies.||||||0.004||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.004
70860636|NCT00395538|141207274|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.O.Th between the baseline and the years 2 and 4 (combined) biopsy.||||||0.006||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.006
70860637|NCT00395538|141207274|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.O.Th between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.67||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.670
70860638|NCT00395538|141207275|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.MAR between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.MAR values for both their baseline and year 1 biopsies.||||||0.003||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.003
70860639|NCT00395538|141207275|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.MAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
70860640|NCT00395538|141207275|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.MAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.712||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.712
70860641|NCT00395538|141207276|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.OS/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.OS/BS values for both their baseline and year 1 biopsies.||||||0.029||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.029
70947427|NCT00905359|141395203|NON_INFERIORITY_OR_EQUIVALENCE|t-test analysis performed using Multiple imputation and one-sided p-value testing non-inferiority of the percentage change from baseline at 10%. One-sided p-value is significant if \<0.025 or the upper limit of the CI is less than 10%.||||||0.172|||||||t-test, 1 sided|||||||0.172
70947428|NCT02654132|141395218|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.0043|TWO_SIDED|95.0|0.32|0.82|||Log Rank|||||0.82|0.32|0.0043
70947429|NCT02654132|141395219|SUPERIORITY||Odds Ratio (OR)|4.62||||0.0002|TWO_SIDED|95.0|2.05|10.43|||Cochran-Mantel-Haenszel|||||10.43|2.05|0.0002
70947430|NCT02654132|141395220|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.0217|TWO_SIDED|95.0|0.37|0.93|||Log Rank|||||0.93|0.37|0.0217
70947431|NCT04706793|141395225|OTHER||Risk Difference (RD)|17.86|||||TWO_SIDED|95.0|-3.1|38.82||||||||38.82|-3.10|
70860642|NCT00395538|141207276|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.OS/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
70860643|NCT00395538|141207276|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.OS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.104||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.104
70860644|NCT00395538|141207277|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.ES/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.ES/BS values for both their baseline and year 1 biopsies.||||||0.088||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.088
70860645|NCT00395538|141207277|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.ES/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.009||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.009
70860646|NCT00395538|141207277|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.ES/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.325||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.325
70860647|NCT00395538|141207278|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.AjAR between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 3 participants with non-missing Ec.AjAR values for both their baseline and year 1 biopsies.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
70860648|NCT00395538|141207278|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.AjAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
70947432|NCT04706793|141395226|OTHER||Risk Difference (RD)|28.57|||||TWO_SIDED|95.0|6.28|50.86||||||||50.86|6.28|
70947433|NCT04706793|141395227|OTHER||Risk Difference (RD)|32.14|||||TWO_SIDED|95.0|9.58|54.71||||||||54.71|9.58|
71132494|NCT01052077|141767845|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.15||||0.2345|TWO_SIDED|95.0|0.91|1.44||CMH general association test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||1.44|0.91|0.2345
71132495|NCT00042991|141767854|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71132496|NCT00042991|141767855|SUPERIORITY_OR_OTHER|||||||0.0546||95.0|||||Wilcoxon (Mann-Whitney)|||19 patients had Enhancing tumor at both Baseline and Post-RT time points. Thus, the following test was based on these 19 patients.||||0.0546
71132497|NCT00042991|141767856|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71132498|NCT00042991|141767857|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.18
71132499|NCT04072887|141767866|SUPERIORITY||Least Squares Mean Difference|0.011|STANDARD_ERROR_OF_MEAN|0.0235||0.628|TWO_SIDED|90.0|-0.027|0.05|||ANCOVA|||||0.050|-0.027|0.628
71132500|NCT04072887|141767866|SUPERIORITY||Least Squares Mean Difference|0.012|STANDARD_ERROR_OF_MEAN|0.0144||0.425|TWO_SIDED|90.0|-0.012|0.035|||ANCOVA|||||0.035|-0.012|0.425
71132501|NCT04072887|141767866|SUPERIORITY||Least Squares Mean Difference|0.013|STANDARD_ERROR_OF_MEAN|0.0174||0.463|TWO_SIDED|90.0|-0.016|0.041|||ANCOVA|||||0.041|-0.016|0.463
71132502|NCT04072887|141767866|SUPERIORITY||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.0173||0.244|TWO_SIDED|90.0|-0.008|0.049|||ANCOVA|||||0.049|-0.008|0.244
71132503|NCT04072887|141767866|SUPERIORITY||Least Squares Mean Difference|0.005|STANDARD_ERROR_OF_MEAN|0.0176||0.793|TWO_SIDED|90.0|-0.024|0.034|||ANCOVA|||||0.034|-0.024|0.793
71132504|NCT02697435|141767882|SUPERIORITY||||||<|0.05||||||P-value is calculated.|Mixed Models Analysis|||||||<0.05
71132505|NCT04371666|141767884|OTHER||Least square (LS) Mean Difference|0.083|STANDARD_ERROR_OF_MEAN|0.5494||0.8802|TWO_SIDED|95.0|-1.01|1.176||Threshold for significance at 0.05 level.|Random coefficient model|||||1.176|-1.010|0.8802
71132506|NCT02974257|141767939|OTHER|Linear mixed-effects model with an independent variance-covariance matrix to account for the correlation of within-patient repeated measures was used and linear contrasts were used to estimate the mean difference between treatment arms at 48 hours.|Mean Difference (Final Values)|1.5||||0.9|TWO_SIDED|95.0|-3.1|6.1||Global p-value from the mixed model.|Mixed Models Analysis|If patients died before 48 hours lactate levels were imputed by carrying forward the last known value before the event with a 20% increase||||6.1|-3.1|0.9
71132507|NCT02974257|141767940|OTHER||Mean Difference (Final Values)|-0.36||||0.42|TWO_SIDED|95.0|-1.29|0.56|||Regression, Linear|||AUC-VO2 normally distributed, used a linear regression model to compare mean AUC-VO2 between treatment groups controlling for average temperature.||0.56|-1.29|0.42
71132508|NCT02974257|141767941|OTHER||Mean Difference (Final Values)|-0.3||||0.07|TWO_SIDED|95.0|-0.9|0.3||Mixed model controlling for repeated measures within patients used to get a mean difference in PDH specific activity between thiamine and placebo groups at 48 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model.||||0.3|-0.9|0.07
71132509|NCT01013194|141767991|SUPERIORITY_OR_OTHER|||||||0.434|TWO_SIDED||||||Fisher Exact|||||||0.4340
71132510|NCT01013194|141767992|SUPERIORITY_OR_OTHER|||||||0.0076|TWO_SIDED||||||t-test, 2 sided|||Comparison at 1 year Follow-up||||0.0076
71132511|NCT01013194|141767993|SUPERIORITY_OR_OTHER|||||||0.0437|TWO_SIDED||||||t-test, 2 sided|||Comparison at 1 year Follow-up||||0.0437
71132512|NCT03329092|141768010|OTHER||Difference in clinical cure rate|2.7|||||TWO_SIDED|95.0|-6.6|12.4|||||The confidence interval (CI) for the difference was calculated using the unstratified Miettinen and Nurminen method.|||12.4|-6.6|
71132513|NCT03329092|141768011|OTHER||Difference in clinical cure rate|2.7|||||TWO_SIDED|95.0|-7.0|13.2|||||The CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||13.2|-7.0|
71132514|NCT03329092|141768012|OTHER||Difference in clinical cure rate|0.5|||||TWO_SIDED|95.0|-10.2|12.1|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||12.1|-10.2|
71132515|NCT03329092|141768013|OTHER||Difference in clinical cure rate|2.6|||||TWO_SIDED|95.0|-8.4|14.7|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||14.7|-8.4|
71132516|NCT03329092|141768014|OTHER||Difference in clinical cure rate|2.4|||||TWO_SIDED|95.0|-7.4|13.0|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|cIAI||13.0|-7.4|
71132517|NCT03329092|141768014|OTHER||Difference in clinical cure rate|4.3|||||TWO_SIDED|95.0|-15.5|23.1|||Difference||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|HAP/VAP||23.1|-15.5|
71132518|NCT03329092|141768015|OTHER||Difference in clinical cure rate|5.6|||||TWO_SIDED|95.0|-4.0|16.6|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|cIAI||16.6|-4.0|
71132519|NCT03329092|141768015|OTHER||Difference in clinical cure rate|-7.9|||||TWO_SIDED|95.0|-31.9|17.3|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|HAP/VAP||17.3|-31.9|
71132520|NCT03329092|141768042|OTHER||Difference in clinical cure rate|2.3|||||TWO_SIDED|95.0|-6.2|11.5|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||11.5|-6.2|
71132521|NCT03329092|141768043|OTHER||Difference in clinical cure|-1.2|||||TWO_SIDED|95.0|-10.7|9.4|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||9.4|-10.7|
71132522|NCT03329092|141768044|OTHER||Difference in clinical cure|0.3|||||TWO_SIDED|95.0|-8.3|9.9|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||9.9|-8.3|
71132523|NCT03329092|141768045|OTHER||Difference in clinical cure rate|1.0|||||TWO_SIDED|95.0|-8.5|12.0|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||12.0|-8.5|
71132524|NCT03329092|141768046|OTHER||Difference in clinical cure rate|1.9|||||TWO_SIDED|95.0|-6.9|11.9|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|cIAI||11.9|-6.9|
71132525|NCT03329092|141768046|OTHER||Difference in clinical cure rate|3.9|||||TWO_SIDED|95.0|-15.2|23.4|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|HAP/VAP||23.4|-15.2|
71132526|NCT03329092|141768047|OTHER||Difference in clinical cure rate|3.1|||||TWO_SIDED|95.0|-5.2|13.2|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|cIAI||13.2|-5.2|
71132527|NCT03329092|141768047|OTHER||Difference in clinical cure rate|-10.4|||||TWO_SIDED|95.0|-32.6|14.9|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|HAP/VAP||14.9|-32.6|
71132528|NCT04273893|141768090|OTHER|||||||0.05||||||Changes from baseline ALC were conducted using repeated measures models with an unstructured covariance matrix and model terms for tumor location, follow-up time. Adjustments for stratification factors were made using least squares means.|t-test, 2 sided|||||||0.05
71132529|NCT03906071|141768092|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.144|TWO_SIDED|95.0|0.7|1.05||The p-value is based on a unstratified log-rank test. (2-Sided)|Log Rank||Based on the unstratified cox proportional hazards model.|||1.05|0.70|0.144
70947434|NCT04706793|141395228|OTHER||Risk Difference (RD)|21.43|||||TWO_SIDED|95.0|-0.07|42.92||||||||42.92|-0.07|
70947435|NCT04706793|141395229|OTHER||Risk Difference (RD)|17.86|||||TWO_SIDED|95.0|-3.1|38.82||||||||38.82|-3.10|
70947436|NCT04706793|141395230|OTHER||Risk Difference (RD)|7.14|||||TWO_SIDED|95.0|-2.4|16.68||||||||16.68|-2.40|
71132530|NCT01456169|141768124|SUPERIORITY_OR_OTHER||LS mean difference|-14.7|||<|0.001|TWO_SIDED|95.0|-17.6|-11.8|||ANCOVA|ANCOVA model with treatment as a fixed effect and baseline trough, sitting, clinic SBP as a covariate.||The type I error was controlled using a 2-step hierarchical testing procedure. In the first step, the high dose (40/25 mg) of Azilsartan medoxomil + chlorthalidone was compared to Azilsartan medoxomil alone. If the comparison in step 1 was statistically significant at a significance level of 5%, then step 2 was performed by comparing the low dose (40/12.5 mg) and monotherapy at the 5% significance level.||-11.8|-17.6|<0.001
71132531|NCT01456169|141768124|SUPERIORITY_OR_OTHER||LS mean difference|-9.5|||<|0.001|TWO_SIDED|95.0|-12.4|-6.5|||ANCOVA|ANCOVA model with treatment as a fixed effect and baseline trough, sitting, clinic SBP as a covariate||||-6.5|-12.4|<0.001
71132532|NCT00394706|141768162|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.2||||0.59|TWO_SIDED|95.0|-1.1|0.7||Two sided test with an a priori threshold of 0.05 for declaring statistical significance.|Mixed Models Analysis||Estimate of the rate of MRS \<= 3 in Analyze Later arm minus rate in Analyze early arm.|Comparison of the rates of MRS \<=3 in Analyze Early vs. Analyze Later arms using a linear mixed effect model with an identity link and random effects to account for the cluster randomization.||0.7|-1.1|0.59
71132533|NCT00394706|141768162|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1||||0.71|TWO_SIDED|95.0|-1.1|0.8||To adjust for group sequential monitoring, the point estimate was bias-adjusted (Whitehead 1986) and confidence intervals and P values calculated from the maximum likelihood based ordering of the outcome(Emerson and Fleming, 1990)|t-test, 2 sided||Estimate of the rate of MRS \<= 3 in the active ITD arm minus the rate in the Sham ITD arm.|Comparison of the rates of MRS \<=3 in Active ITD and Sham treatment arms, adjusted for sequential monitoring.||0.8|-1.1|0.71
71132534|NCT00394706|141768163|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1||||0.92|TWO_SIDED|95.0|-1.2|1.1||Two sided test with an a priori threshold of 0.05 for declaring statistical significance.|GEE||Estimate of the rate of survival to hospital discharge in Analyze Later arm minus rate in Analyze early arm.|Comparison of the rates of survival to hospital discharge in Analyze Early vs. Analyze Later arms using a generalized estimating equations model with an identity link, grouping on cluster.||1.1|-1.2|0.92
71132535|NCT00394706|141768163|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||0.99|TWO_SIDED|95.0|-1.2|1.1|||t-test, 2 sided||Estimate of the rate of survival to hospital discharge in the active ITD arm minus rate in the Sham ITD arm.|Comparison of the rates of survival to hospital discharge in Active ITD and Sham treatment arms.||1.1|-1.2|0.99
71132536|NCT00394706|141768164|SUPERIORITY||Mean Difference (Final Values)|0.07|||||TWO_SIDED|95.0|-0.2|0.34|||||Mean MRS for Analyze Later minus mean MRS for Analyze Early (i.e. positive values favor Analyze Later).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.||0.34|-0.20|
71132537|NCT00394706|141768164|SUPERIORITY||Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-0.17|0.44|||||Mean MRS for Active ITD minus mean MRS for Sham ITD (i.e. positive values favor the active device).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.||0.44|-0.17|
71132538|NCT00394706|141768165|SUPERIORITY||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.71|0.83|||||Mean ALFI-MMSE for Analyze Later minus mean ALFI-MMSE for Analyze Early (i.e. positive values favor Analyze Later).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.||0.83|-0.71|
71132539|NCT00394706|141768165|SUPERIORITY||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-1.61|0.28|||||Mean ALFI-MMSE for Active ITD minus mean ALFI-MMSE for Sham ITD (i.e. positive values favor the active device).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.||0.28|-1.61|
70872098|NCT02155608|141229491|SUPERIORITY|||||||0.01||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 6.89, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.01
70947437|NCT02601209|141395234|OTHER||Maximum Tolerated Dose (mg)|30.0|||||TWO_SIDED|||||||||||||
70947438|NCT02601209|141395235|SUPERIORITY||Hazard Ratio (HR)|1.36||||0.1419|ONE_SIDED|85.0||1.7|||Log Rank|1-sided statistical test and p-value||||1.70||0.1419
70947439|NCT03636373|141395247|NON_INFERIORITY|On a 10 point Likert Pain Scale, non-inferiority margin for the difference is 1.04. Using a Student t-test, there was 80% power for the difference in pain levels to exceed -1.04.||||||1|||||||t-test, 1 sided|||Mean Outcome measure Etanercept arm { ( 8 + 0 + 7)/3 = 5} Triamcinolone Arm { (3+0) /2 = 1.5 }||||1.00
70947440|NCT03636373|141395248|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.00
70947441|NCT03636373|141395249|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
70947442|NCT03636373|141395250|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
70947443|NCT03636373|141395251|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
70947444|NCT03636373|141395252|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
70947445|NCT04486313|141395344|SUPERIORITY|||||||0.8786|||||||Gehan-Wilcoxon Test|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.8786
70860649|NCT00395538|141207278|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.AjAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.974||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.974
70860650|NCT00395538|141207279|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.O.Th between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.O.Th values for both their baseline and year 1 biopsies.||||||0.004||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.004
70860651|NCT00395538|141207279|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.O.Th between the baseline and the years 2 and 4 (combined) biopsy.||||||0.023||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.023
70860652|NCT00395538|141207279|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.O.Th between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.288||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.288
70860653|NCT00395538|141207280|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.MAR between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.MAR values for both their baseline and year 1 biopsies.||||||0.202||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.202
70860654|NCT00395538|141207280|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.MAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.486||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.486
70872099|NCT02155608|141229491|SUPERIORITY|||||||0.15||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F= 2.16, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.15
70872100|NCT02155608|141229491|SUPERIORITY|||||||0.05||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 4.15, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.05
70947446|NCT04486313|141395345|SUPERIORITY|||||||0.074||||||Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness|Cochran-Mantel-Haenszel|||||||0.0740
70947447|NCT04486313|141395346|SUPERIORITY|||||||0.4479|||||||Cochran-Mantel-Haenszel|||Comparison of proportion positive for SARS-CoV-2 at Day 4||||0.4479
70947448|NCT04486313|141395346|SUPERIORITY|||||||0.2814|||||||Cochran-Mantel-Haenszel|||Comparison of proportion positive for SARS-CoV-2 at Day 10||||0.2814
70947449|NCT04486313|141395347|SUPERIORITY|||||||0.0665|||||||t-test, 2 sided|||Comparison of change from Baseline to Day 4||||0.0665
70947450|NCT04486313|141395347|SUPERIORITY|||||||0.4974|||||||t-test, 2 sided|||Comparison of change from Baseline to Day 10||||0.4974
70947451|NCT04486313|141395348|SUPERIORITY|||||||0.1771|||||||Cochran-Mantel-Haenszel|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.1771
70872101|NCT02155608|141229491|SUPERIORITY|||||||0.79||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .07, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.79
70947452|NCT04486313|141395349|SUPERIORITY|||||||0.2399|||||||Cochran-Mantel-Haenszel|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.2399
70872102|NCT02155608|141229492|SUPERIORITY|||||||0.94||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .01, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.94
70947453|NCT04486313|141395350|SUPERIORITY|||||||0.09|||||||Gehan-Wilcoxon Test|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.09
70947454|NCT04486313|141395351|SUPERIORITY|||||||0.0077|||||||Gehan-Wilcoxon Test|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.0077
70947455|NCT04486313|141395352|SUPERIORITY|||||||0.05|||||||Cochran-Mantel-Haenszel|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.05
70860655|NCT00395538|141207280|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.MAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.535||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.535
70860656|NCT00395538|141207281|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.OS/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.OS/BS values for both their baseline and year 1 biopsies.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
70947456|NCT04486313|141395353|SUPERIORITY|||||||0.05|||||||Cochran-Mantel-Haenszel|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.05
70947457|NCT04486313|141395354|SUPERIORITY|||||||0.08|||||||Cochran-Mantel-Haenszel|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.08
70947458|NCT01496365|141395355|SUPERIORITY||Least squares mean|-0.05||||0.8916|TWO_SIDED|95.0|-0.81|0.7|||ANCOVA|||||0.70|-0.81|0.8916
70947459|NCT01496365|141395355|SUPERIORITY||Least squares mean|-0.22||||0.5569|TWO_SIDED|95.0|-0.95|0.51|||ANCOVA|||||0.51|-0.95|0.5569
70947460|NCT01496365|141395355|SUPERIORITY||Least squares mean|-0.53||||0.1544|TWO_SIDED|95.0|-1.25|0.2|||ANCOVA|||||0.20|-1.25|0.1544
70947461|NCT01496365|141395355|SUPERIORITY||Least squares mean|-0.94||||0.0137|TWO_SIDED|95.0|-1.69|-0.19|||ANCOVA|||||-0.19|-1.69|0.0137
70947462|NCT01496365|141395355|SUPERIORITY||Least squares mean|-0.88||||0.0171|TWO_SIDED|95.0|-1.61|0.16|||ANCOVA|||||0.16|-1.61|0.0171
70947463|NCT01496365|141395355|SUPERIORITY||Least square means|-1.01||||0.006|TWO_SIDED|95.0|-1.74|-0.29|||ANCOVA|||||-0.29|-1.74|0.0060
70947464|NCT01496365|141395355|SUPERIORITY||Least squares mean|-0.17||||0.7051|TWO_SIDED|95.0|-1.03|0.69|||ANCOVA|||||0.69|-1.03|0.7051
70947465|NCT01496365|141395355|SUPERIORITY||Least squares mean|-0.47||||0.2772|TWO_SIDED|95.0|-1.33|0.38|||ANCOVA|||||0.38|-1.33|0.2772
70947466|NCT01496365|141395355|SUPERIORITY||Least squares mean|-0.89||||0.0458|TWO_SIDED|95.0|-1.77|-0.02|||ANCOVA|||||-0.02|-1.77|0.0458
70947467|NCT01496365|141395355|SUPERIORITY||Least squares mean|-0.83||||0.0569|TWO_SIDED|95.0|-1.69|0.02|||ANCOVA|||||0.02|-1.69|0.0569
70947468|NCT01496365|141395355|SUPERIORITY||Least squares mean|-0.96||||0.0271|TWO_SIDED|95.0|-1.81|-0.11|||ANCOVA|||||-0.11|-1.81|0.0271
70947469|NCT02706951|141395369|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|26.5|||<|0.001|TWO_SIDED|95.0|17.5|35.6||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||35.6|17.5|<0.001
70947470|NCT02706951|141395369|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|30.0|||<|0.001|TWO_SIDED|95.0|21.0|38.9||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||38.9|21.0|<0.001
70947471|NCT02706951|141395370|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|25.3|||<|0.001|TWO_SIDED|95.0|16.8|33.7||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||33.7|16.8|<0.001
70947472|NCT02706951|141395370|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|33.6|||<|0.001|TWO_SIDED|95.0|25.1|42.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||42.1|25.1|<0.001
70947473|NCT02706951|141395371|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Least Squares (LS) Mean Difference|-1.08|||<|0.001|TWO_SIDED|95.0|-1.32|-0.85||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|Analysis of covariance (ANCOVA) model with treatment as the fixed factor, and baseline value and geographic region as the covariates.|Difference = Upadacitinib - Methotrexate|||-0.85|-1.32|<0.001
70947474|NCT02706951|141395371|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|-1.4|||<|0.001|TWO_SIDED|95.0|-1.64|-1.17||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment as the fixed factor, and baseline value and the stratification factor geographic region as the covariates.|Difference = Upadacitinib - Methotrexate|||-1.17|-1.64|<0.001
71132540|NCT00394706|141768166|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.06|0.05|||||Mean HUI for Analyze Later minus mean HUI for Analyze Early (i.e. positive values favor Analyze Later).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.||0.05|-0.06|
71132541|NCT00394706|141768166|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.08|0.05|||||Mean HUI for Active ITD minus mean HUI for Sham ITD (i.e. positive values favor the active device).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.||0.05|-0.08|
71132542|NCT03369249|141768171|SUPERIORITY||log ratio of rate ratios|0.15|STANDARD_ERROR_OF_MEAN|0.31||0.635|TWO_SIDED|95.0|-0.46|0.75||A priori threshold for statistical significance was \<0.05|generalized estimating equations||Standard error of the Beta regression coefficient.|||0.75|-0.46|0.635
71132543|NCT01200368|141768216|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was greater than (\>) -0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.2|2.1||||||Serotype 4: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95 percent (%) confidence interval (CI).||2.1|-2.2|
71132544|NCT01200368|141768216|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|-1.7|||||TWO_SIDED|95.0|-5.2|1.1||||||Serotype 6B: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||1.1|-5.2|
71132545|NCT01200368|141768216|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Serotype 9V: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.1|-2.1|
70860657|NCT00395538|141207281|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.OS/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.003||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.003
70860658|NCT00395538|141207281|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.OS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.328||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.328
70872103|NCT02155608|141229492|SUPERIORITY|||||||0.76||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = .09, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.76
71132546|NCT01200368|141768216|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Serotype 14: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.1|-2.1|
71132547|NCT01200368|141768216|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Serotype 18C: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.1|-2.1|
71132548|NCT01200368|141768216|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|2.3|||||TWO_SIDED|95.0|-1.1|6.3||||||Serotype 19F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||6.3|-1.1|
71132549|NCT01200368|141768216|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|-0.6|||||TWO_SIDED|95.0|-4.2|2.9||||||Serotype 23F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.9|-4.2|
71132550|NCT01200368|141768216|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|3.4|||||TWO_SIDED|95.0|0.9|7.3||||||Serotype 1: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||7.3|0.9|
71132551|NCT01200368|141768216|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|2.9|||||TWO_SIDED|95.0|-0.2|6.7||||||Serotype 3: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||6.7|-0.2|
71132552|NCT01200368|141768216|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|2.9|||||TWO_SIDED|95.0|-0.2|6.7||||||Serotype 5: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||6.7|-0.2|
71132553|NCT01200368|141768216|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|1.7|||||TWO_SIDED|95.0|-1.9|5.8||||||Serotype 6A: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||5.8|-1.9|
71132554|NCT01200368|141768216|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|3.4|||||TWO_SIDED|95.0|0.9|7.3||||||Serotype 7F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||7.3|0.9|
71132555|NCT01200368|141768216|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|3.4|||||TWO_SIDED|95.0|1.0|7.3||||||Serotype 19A: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||7.3|1.0|
71132556|NCT01200368|141768217|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for the IgG GMC ratio was \>0.5.|GMC ratio|0.81|||||TWO_SIDED|95.0|0.71|0.94||||||Serotype 4: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.94|0.71|
71132557|NCT01200368|141768217|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.79|||||TWO_SIDED|95.0|0.64|0.97||||||Serotype 6B: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.97|0.64|
70860659|NCT00395538|141207282|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.ES/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.ES/BS values for both their baseline and year 1 biopsies.||||||0.002||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.002
70872104|NCT02155608|141229492|SUPERIORITY|||||||0.39||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .75, df =1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.39
70872105|NCT02155608|141229492|SUPERIORITY|||||||0.09||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = 3.06, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.09
70860660|NCT00395538|141207282|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.ES/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
70872106|NCT02155608|141229492|SUPERIORITY|||||||0.79||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = .07, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.79
70947475|NCT02706951|141395372|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|-0.33|||<|0.001|TWO_SIDED|95.0|-0.43|-0.22||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment as the fixed factor, and baseline value and the stratification factor geographic region as the covariates.|Difference = Upadacitinib - Methotrexate|||-0.22|-0.43|<0.001
71132558|NCT01200368|141768217|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.74|||||TWO_SIDED|95.0|0.64|0.86||||||Serotype 9V: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.86|0.64|
70872107|NCT02155608|141229492|SUPERIORITY|||||||0.22||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 1.55, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.22
71132559|NCT01200368|141768217|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.83|||||TWO_SIDED|95.0|0.7|0.98||||||Serotype 14: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.98|0.70|
71132560|NCT01200368|141768217|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.73|||||TWO_SIDED|95.0|0.63|0.85||||||Serotype 18C: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.85|0.63|
71132561|NCT01200368|141768217|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.88|||||TWO_SIDED|95.0|0.72|1.08||||||Serotype 19F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||1.08|0.72|
71132562|NCT01200368|141768217|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.8|||||TWO_SIDED|95.0|0.66|0.98||||||Serotype 23F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.98|0.66|
71132563|NCT01200368|141768218|SUPERIORITY_OR_OTHER||Percent difference|-0.6|||||TWO_SIDED|95.0|-3.1|1.6||||||Difference in percentage of participants achieving predefined antibody levels for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.||1.6|-3.1|
71132564|NCT01200368|141768218|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-2.1|2.2||||||Difference in percentage of participants achieving predefined antibody levels for tetanus toxoid and corresponding 2-sided 95% CI were calculated.||2.2|-2.1|
71132565|NCT01200368|141768218|SUPERIORITY_OR_OTHER||Percent difference|-0.6|||||TWO_SIDED|95.0|-3.1|1.6||||||Difference in percentage of participants achieving predefined antibody levels for pertussis toxoid and corresponding 2-sided 95% CI were calculated.||1.6|-3.1|
71132566|NCT01200368|141768218|SUPERIORITY_OR_OTHER||Percent difference|-0.6|||||TWO_SIDED|95.0|-3.1|1.6||||||Difference in percentage of participants achieving predefined antibody levels for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.||1.6|-3.1|
71132567|NCT01200368|141768219|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.8|||||TWO_SIDED|95.0|1.5|2.15||||||Serotype 1: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||2.15|1.50|
71132568|NCT01200368|141768219|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.08|||||TWO_SIDED|95.0|0.92|1.28||||||Serotype 3: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||1.28|0.92|
71132569|NCT01200368|141768219|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.03|||||TWO_SIDED|95.0|0.86|1.22||||||Serotype 5: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||1.22|0.86|
71132570|NCT01200368|141768219|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.04|||||TWO_SIDED|95.0|0.87|1.25||||||Serotype 6A: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||1.25|0.87|
71132571|NCT01200368|141768219|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.83|||||TWO_SIDED|95.0|1.54|2.16||||||Serotype 7F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||2.16|1.54|
71132572|NCT01200368|141768219|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.89|||||TWO_SIDED|95.0|1.59|2.25||||||Serotype 19A: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||2.25|1.59|
71132573|NCT01200368|141768220|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.4||||||Serotype 4: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-2.4|
71132574|NCT01200368|141768220|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.4||||||Serotype 6B: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-2.4|
71132575|NCT01200368|141768220|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.4||||||Serotype 9V: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-2.4|
71132576|NCT01200368|141768220|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.4||||||Serotype 14: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-2.4|
71132577|NCT01200368|141768220|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.4||||||Serotype 18C: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-2.4|
71132578|NCT01200368|141768220|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|-0.6|||||TWO_SIDED|95.0|-3.9|2.4||||||Serotype 19F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-3.9|
71132579|NCT01200368|141768220|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.4||||||Serotype 23F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-2.4|
71132580|NCT01200368|141768220|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.9|3.0||||||Serotype 1: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||3.0|-2.9|
71132581|NCT01200368|141768220|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.9|3.0||||||Serotype 3: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||3.0|-2.9|
71132582|NCT01200368|141768220|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.6|||||TWO_SIDED|95.0|-1.7|3.6||||||Serotype 5: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||3.6|-1.7|
71132583|NCT01200368|141768220|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.6|||||TWO_SIDED|95.0|-1.7|3.6||||||Serotype 6A: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||3.6|-1.7|
71132584|NCT01200368|141768220|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.6|||||TWO_SIDED|95.0|-1.7|3.6||||||Serotype 7F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||3.6|-1.7|
71132585|NCT01200368|141768220|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.6|||||TWO_SIDED|95.0|-1.7|3.6||||||Serotype 19A: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||3.6|-1.7|
71132586|NCT01200368|141768221|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.94|||||TWO_SIDED|95.0|0.77|1.15||||||Serotype 4: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||1.15|0.77|
71132587|NCT01200368|141768221|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.23|||||TWO_SIDED|95.0|0.98|1.53||||||Serotype 6B: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||1.53|0.98|
71132588|NCT01200368|141768221|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.81|||||TWO_SIDED|95.0|0.67|0.98||||||Serotype 9V: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.98|0.67|
71132589|NCT01200368|141768221|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.95|||||TWO_SIDED|95.0|0.81|1.12||||||Serotype 14: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||1.12|0.81|
71132590|NCT01200368|141768221|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.82|||||TWO_SIDED|95.0|0.67|1.01||||||Serotype 18C: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||1.01|0.67|
71132591|NCT01200368|141768221|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.75|||||TWO_SIDED|95.0|1.39|2.21||||||Serotype 19F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||2.21|1.39|
71132592|NCT01200368|141768221|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.86|||||TWO_SIDED|95.0|0.7|1.07||||||Serotype 23F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||1.07|0.70|
70860661|NCT00395538|141207282|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Ic.ES/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.789||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.789
70860662|NCT00395538|141207283|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.AjAR between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.AjAR values for both their baseline and year 1 biopsies.||||||0.651||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.651
70860663|NCT00395538|141207283|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.AjAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.58||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.580
70860664|NCT00395538|141207283|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.AjAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.338||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.338
70860665|NCT00395538|141207284|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Mean between the baseline and the year 1 biopsy.||||||0.02||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Mean as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.020
70860666|NCT00395538|141207284|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Mean between the baseline and the years 2 and 4 (combined) biopsy.||||||0.11||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Mean as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.110
70860667|NCT00395538|141207284|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Mean between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.764||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Mean as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.764
70860668|NCT00395538|141207285|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Peak between the baseline and the year 1 biopsy.||||||0.227||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Peak as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.227
70872108|NCT02155608|141229493|SUPERIORITY|||||||0.64||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .22, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.64
71132593|NCT01200368|141768221|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.62|||||TWO_SIDED|95.0|1.31|1.99||||||Serotype 1: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||1.99|1.31|
70860669|NCT00395538|141207285|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Peak between the baseline and the years 2 and 4 (combined) biopsy.||||||0.194||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Peak as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.194
70860670|NCT00395538|141207285|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Peak between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.434||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Peak as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.434
70860671|NCT00395538|141207286|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Width between the baseline and the year 1 biopsy.||||||0.003||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Width as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.003
70860672|NCT00395538|141207286|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Width between the baseline and the years 2 and 4 (combined) biopsy.||||||0.002||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Width as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.002
70860673|NCT00395538|141207286|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Width between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.787||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Width as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.787
70860674|NCT00395538|141207287|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Low between the baseline and the year 1 biopsy.||||||0.082||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Low as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.082
70860675|NCT00395538|141207287|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Low between the baseline and the years 2 and 4 (combined) biopsy.||||||0.057||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Low as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.057
70860676|NCT00395538|141207287|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Low between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.547||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Low as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.547
70860677|NCT00395538|141207288|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium High between the baseline and the year 1 biopsy.||||||0.922||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium High as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.922
70872109|NCT02155608|141229493|SUPERIORITY|||||||0.19||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 1.49, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.19
70872110|NCT02155608|141229493|SUPERIORITY|||||||0.22||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 1.49, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.22
70860678|NCT00395538|141207288|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium High between the year 1 and the years 2 and 4 (combined) biopsy.||||||0.342||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium High as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.342
70860679|NCT00395538|141207288|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium High between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.449||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium High as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.449
70860680|NCT01074047|141207321|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0829|TWO_SIDED|95.0|0.69|1.02|||Log Rank|The p-value is two-sided from an unstratified log-rank test|The hazard ratio is from a Cox proportional hazards model stratified by ECOG performance status and cytogenetic risk status.|||1.02|0.69|0.0829
70860681|NCT01074047|141207321|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.1009|TWO_SIDED|95.0|0.69|1.03|||Log Rank||The hazard ratio is from a Cox proportional hazards model stratified by ECOG performance status and cytogenetic risk status.|||1.03|0.69|0.1009
70860682|NCT01074047|141207322|SUPERIORITY_OR_OTHER||Difference|12.26|||||TWO_SIDED|95.0|3.5|21.0|||||Estimates of the 1-year (365 day) survival probabilities and corresponding 95% confidence intervals (CI) were presented by treatment group. The CI for the difference in the 1-year survival probabilities was derived using Greenwoods variance estimate.|||21.0|3.5|
70860683|NCT01074047|141207323|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.1495|TWO_SIDED|95.0|0.72|1.05|||Log Rank|2 sided unstratified|The hazard ratio is from an unstratified Cox proportional hazards model.|Median is estimated from a Kaplan-Meier distribution of EFS||1.05|0.72|0.1495
70860684|NCT01074047|141207324|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.5832|TWO_SIDED|95.0|0.75|1.66|||Log Rank|2 sided unstratified|The hazard ratio is from an unstratified Cox proportional hazards model.|Median is estimated from a Kaplan-Meier distribution of RFS||1.66|0.75|0.5832
70860685|NCT01074047|141207325|SUPERIORITY_OR_OTHER|||||||0.5384|||||||Fisher Exact|P-value is from Fishers exact test||||||0.5384
70860686|NCT01074047|141207327|SUPERIORITY_OR_OTHER|||||||0.0376|||||||Fisher Exact|P-value is from Fishers exact test||||||0.0376
70860687|NCT01074047|141207351|SUPERIORITY_OR_OTHER||Relative Ratio|0.79||||0.0721|TWO_SIDED|95.0|0.62|1.02|||negative binomial regression analysis|||||1.02|0.62|0.0721
70860688|NCT00859027|141207356|OTHER|||||||0.004|||||||One way ANOVA|||Percent change in femoral neck BMD from baseline||||0.004
70860689|NCT00859027|141207356|OTHER|||||||0.001|||||||One way ANOVA|||Percent change in total hip BMD from baseline||||0.001
70860690|NCT00859027|141207356|OTHER|||||||0.04|||||||One way ANOVA|||Percent change in lumbar spine BMD from baseline||||0.04
70860691|NCT00859027|141207356|OTHER||||||<|0.01|||||||ANOVA|||Between group difference of percent change for the femoral neck BMD||||<0.01
70860692|NCT00859027|141207356|OTHER||||||<|0.01|||||||ANOVA|||Between group difference of percent change for total hip BMD||||<0.01
70860693|NCT00859027|141207357|OTHER|||||||0.015|||||||ANOVA|||Between group difference of percent change for NTX||||0.015
70860694|NCT00859027|141207357|OTHER|||||||0.01|||||||ANOVA|||Between group difference of percent change for CTX||||0.01
70860695|NCT02775903|141207390|SUPERIORITY|||||||0.1838|||||||Wald asymptotic two-sided test|||||||0.1838
70860696|NCT02775903|141207391|SUPERIORITY|||||||0.618|||||||Wald asymptotic two-sided test|||||||0.6180
70860697|NCT02775903|141207392|OTHER|P-values were not part of the formal testing.||||||0.7016|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor)||||||0.7016
70860698|NCT02775903|141207393|OTHER|P-values were not part of the formal testing.||||||0.6076|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).||||||0.6076
70860699|NCT02775903|141207394|OTHER|P-values were not part of the formal testing.||||||0.384|||||||Wald asymptotic two-sided test|||||||0.3840
70860700|NCT02775903|141207395|OTHER|P-values were not part of the formal testing.||||||0.8961|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).||||||0.8961
70860701|NCT02775903|141207396|OTHER|P-values were not part of the formal testing.||||||0.3591|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).||||||0.3591
70860702|NCT02775903|141207397|OTHER|P-values were not part of the formal testing.||||||0.9031|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).||||||0.9031
70860703|NCT02775903|141207399|OTHER|P-values were not part of the formal testing.||||||0.2409|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very intermediate vs poor).||||||0.2409
70860704|NCT02775903|141207400|OTHER|P-values were not part of the formal testing.||||||0.0688|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (intermediate vs poor).||||||0.0688
70860705|NCT02775903|141207401|OTHER|P-values were not part of the formal testing.||||||0.4894|||||||Wald asymptotic two-sided test|||||||0.4894
70860706|NCT02775903|141207403|OTHER|P-values were not part of the formal testing.||||||0.0381|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (intermediate vs poor).||||||0.0381
70860707|NCT02775903|141207405|OTHER|P-values were not part of the formal testing.||||||0.8973|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).||||||0.8973
70860708|NCT02775903|141207405|OTHER|P-values were not part of the formal testing.||||||0.0691|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (intermediate vs poor).||||||0.0691
70860709|NCT03954041|141207440|SUPERIORITY||LS mean difference|4.62|||=|0.3752|TWO_SIDED|95.0|-5.74|14.98||P-value was analyzed by ANCOVA model with covariates: treatment, interactive response technology (IRT) stratification factors at randomization, baseline total contusion volume based on central read, imaging modality at Hour 96 (MRI vs NCCT).|ANCOVA|||Statistical analysis of combined BIIB093 vs placebo||14.98|-5.74|= 0.3752
70860710|NCT03954041|141207441|SUPERIORITY||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.4|3.36||||||Statistical analysis of combined BIIB093 vs placebo||3.36|0.40|
70860711|NCT03954041|141207442|SUPERIORITY||Odds Ratio (OR)|1.47|||=|0.4306|TWO_SIDED|95.0|0.56|3.86||P-value was analyzed by ordinal logistic regression on mRS adjusting for covariates: treatment, IRT stratification factors at randomization, baseline mRS score, and baseline total contusion volume based on central read.|Regression, Logistic|||Statistical analysis of combined BIIB093 vs placebo||3.86|0.56|=0.4306
70860712|NCT03954041|141207444|SUPERIORITY||LS Mean difference|-1.53|||=|0.6478|TWO_SIDED|95.0|-8.19|5.13||P-value was analyzed by ANCOVA model with covariates: treatment, IRT stratification factors at randomization, baseline total contusion volume based on central read.|ANCOVA|||Statistical analysis of combined BIIB093 vs placebo||5.13|-8.19|= 0.6478
70860713|NCT03954041|141207445|SUPERIORITY||LS Mean Difference|-0.09|||=|0.9314|TWO_SIDED|95.0|-2.2|2.02||P-value was analyzed by ANCOVA model with covariates: treatment, IRT stratification factors at randomization, baseline Glasgow Coma Scale (GCS) based on eCRF, and baseline absolute hematoma volume based on central read.|ANCOVA|||Statistical analysis of combined BIIB093 vs placebo||2.02|-2.20|=0.9314
70860714|NCT03954041|141207446|SUPERIORITY||LS Mean difference|2.18|||=|0.6569|TWO_SIDED|95.0|-7.61|11.98||P-value was analyzed by ANCOVA model with covariates: treatment, IRT stratification factors at randomization, baseline absolute edema volume based on central read, baseline GCS based on eCRF, and imaging modality at Hour 96 (MRI vs NCCT).|ANCOVA|||Statistical analysis of combined BIIB093 vs placebo||11.98|-7.61|= 0.6569
70860715|NCT05007717|141207488|SUPERIORITY||Risk Ratio (RR)|1.04||||0.631|TWO_SIDED|95.0|0.89|1.2|||Mixed Models Analysis|Adjusted for ever missing a visit during a 6 months pre-enrollment period and always coming to clinic by yourself.||||1.20|0.89|0.631
70860716|NCT05007717|141207489|SUPERIORITY||Risk Ratio (RR)|0.79||||0.237|TWO_SIDED|95.0|0.54|1.16|||Mixed Models Analysis|Adjusted for ever being virally unsuppressed during a 6 months pre-enrollment period and always coming to clinic by yourself.||||1.16|0.54|0.237
70860717|NCT05007717|141207490|SUPERIORITY||Risk Ratio (RR)|0.98||||0.386|TWO_SIDED|95.0|0.94|1.02|||Mixed Models Analysis|Adjusted for always having \>80% coverage during a 6 months pre-enrollment period and always coming to clinic by yourself.||||1.02|0.94|0.386
70860718|NCT05007717|141207491|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.991|TWO_SIDED|95.0|0.71|1.41|||Regression, Cox|Adjusted for always coming to clinic by yourself.||||1.41|0.71|0.991
70860719|NCT05007717|141207492|SUPERIORITY||Risk Ratio (RR)|1.21||||0.037|TWO_SIDED|95.0|1.01|1.46|||Mixed Models Analysis|Adjusted for having been given fast track visits during a 6 months pre-enrollment period and always coming to clinic by yourself.||||1.46|1.01|0.037
70860720|NCT05007717|141207493|SUPERIORITY||Risk Ratio (RR)|1.04||||0.276|TWO_SIDED|95.0|0.97|1.12|||Mixed Models Analysis|Adjusted for having been given long intervals during a 6 months pre-enrollment period and always coming to clinic by yourself.||||1.12|0.97|0.276
70860721|NCT02840240|141207505|NON_INFERIORITY|Noninferiority deltas were defined a priori as 1.1 for the ratio in geometric means of opioid consumption converted to IV morphine equivalents (ie, no more than 10% difference between group's median doses) and 1 point for pain score (ie, no more than 1 point worse).|Mean Difference (Final Values)|-0.19||||0.003|TWO_SIDED|95.0|-1.07|0.69|||Regression, Linear|||||0.69|-1.07|0.003
70947476|NCT02706951|141395372|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|-0.41|||<|0.001|TWO_SIDED|95.0|-0.51|-0.3||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment as the fixed factor, and baseline value and the stratification factor geographic region as the covariates.|Difference = Upadacitinib - Methotrexate|||-0.30|-0.51|<0.001
70860722|NCT02840240|141207506|NON_INFERIORITY|Noninferiority deltas were defined a priori as 1.1 for the ratio in geometric means of opioid consumption converted to IV morphine equivalents (ie, no more than 10% difference between group's median doses) and 1 point for pain score (ie, no more than 1 point worse).|Ratio of geometric means|2.12||||0.77|TWO_SIDED|95.0|0.21|18.54|||Regression, Linear|||Comparisons of opioid consumption were conducted independently for each study site. This analysis is for patients at the Cleveland Clinic main campus.||18.54|0.21|0.77
70860723|NCT02840240|141207506|NON_INFERIORITY|Noninferiority deltas were defined a priori as 1.1 for the ratio in geometric means of opioid consumption converted to IV morphine equivalents (ie, no more than 10% difference between group's median doses) and 1 point for pain score (ie, no more than 1 point worse).|Ratio of geometric means|0.32||||0.09|TWO_SIDED|95.0|0.03|3.16|||Regression, Linear|||Comparisons of opioid consumption were conducted independently for each study site. This analysis is for patients at the Cleveland Clinic Fairview hospital.||3.16|0.03|0.09
70860724|NCT02840240|141207507|SUPERIORITY||Odds Ratio (OR)|3.5||||0.11|TWO_SIDED|98.75|0.5|24.3|||Regression, Logistic|||||24.3|0.5|0.11
70860725|NCT02840240|141207508|SUPERIORITY||Odds Ratio (OR)|0.7||||0.6|TWO_SIDED|98.75|0.2|3.1|||Regression, Logistic|||||3.1|0.2|0.60
70860726|NCT02131532|141207523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.25|STANDARD_ERROR_OF_MEAN|3.321||0.03|TWO_SIDED|95.0|1.398|17.102|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in fatigue scores between baseline and three-month assessments||17.102|1.398|0.03
70860727|NCT02131532|141207524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.625|STANDARD_ERROR_OF_MEAN|1.401||0.1|TWO_SIDED|95.0|-0.687|5.937|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in depression scores between baseline and three-month assessments||5.937|-0.687|0.10
70860728|NCT02131532|141207525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.313||0.45|TWO_SIDED|95.0|-0.991|0.491|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in independence scores between baseline and three-month assessments||0.491|-0.991|0.45
70860729|NCT02131532|141207526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.875|STANDARD_ERROR_OF_MEAN|5.03||0.03|TWO_SIDED|95.0|-25.769|-1.981|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in scores of general rating of recovery between baseline and three-month assessments||-1.981|-25.769|0.03
70860730|NCT02131532|141207527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.781|STANDARD_ERROR_OF_MEAN|5.594||0.89|TWO_SIDED|95.0|-14.01|12.448|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in physical strength scores between baseline and three-month assessments||12.448|-14.010|0.89
70860731|NCT02131532|141207528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.105|STANDARD_ERROR_OF_MEAN|2.378||0.009|TWO_SIDED|95.0|-7.729|3.519|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in memory and thinking scores between baseline and three-month assessments||3.519|-7.729|0.009
70860732|NCT02131532|141207529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.403|STANDARD_ERROR_OF_MEAN|5.168||0.009|TWO_SIDED|95.0|-30.624|-6.183|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in emotion scores between baseline and three-month assessments||-6.183|-30.624|0.009
70860733|NCT02131532|141207530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.142|STANDARD_ERROR_OF_MEAN|3.696||0.1|TWO_SIDED|95.0|-15.883|1.598|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in communication scores between baseline and three-month assessments||1.598|-15.883|0.10
70860734|NCT02131532|141207531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|1.25||0.09|TWO_SIDED|95.0|-5.455|0.455|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in daily activities scores between baseline and three-month assessments||0.455|-5.455|0.09
70947477|NCT02706951|141395373|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|3.97|||<|0.001|TWO_SIDED|95.0|2.52|5.42||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, treatment-by-visit interaction, and geographic region, and the baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||5.42|2.52|<0.001
70860735|NCT02131532|141207532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.821|STANDARD_ERROR_OF_MEAN|1.382||0.03|TWO_SIDED|95.0|-7.091|-0.551|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in mobility scores between baseline and three-month assessments||-0.551|-7.091|0.03
70860736|NCT02131532|141207533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.875|STANDARD_ERROR_OF_MEAN|3.264||0.58|TWO_SIDED|95.0|-9.594|5.844||The critical level was adjusted for the multiple comparisons for the eight subscales of the Stroke Impact Scale|t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in hand function scores between baseline and three-month assessments||5.844|-9.594|0.58
70860737|NCT02131532|141207534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.576|STANDARD_ERROR_OF_MEAN|3.691||0.006|TWO_SIDED|95.0|-23.304|-5.847||The critical level was adjusted for the multiple comparisons for the eight subscales of the Stroke Impact Scale|t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in social activity scores between baseline and three-month assessments||-5.847|-23.304|0.006
70860738|NCT01466595|141207539|SUPERIORITY_OR_OTHER|||||||0.028||||||not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|no other adjustments||"Null hypothesis:~There is no difference between the two arms in the change in T-cell activation from baseline to week 4"||||0.028
70860739|NCT00450112|141207582|SUPERIORITY_OR_OTHER||||||>|0.1||95.0|||||Fisher Exact|||||||>0.1
70860740|NCT00450112|141207583|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.||||<0.0001
70860741|NCT00450112|141207583|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.||||<0.0001
70860742|NCT00450112|141207584|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.||||<0.0001
70860743|NCT00450112|141207584|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.||||<0.0001
70860744|NCT00450112|141207585|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.||||<0.0001
70860745|NCT00450112|141207585|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.||||<0.0001
70860746|NCT00450112|141207586|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed..||||<0.0001
70860747|NCT00450112|141207586|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.||||<0.0001
70860748|NCT00450112|141207588|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.||||<0.0001
70860749|NCT00450112|141207588|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.||||<0.0001
70860750|NCT00450112|141207589|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.||||<0.0001
70860751|NCT00450112|141207589|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.||||<0.0001
70947478|NCT02706951|141395373|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|5.87|||<|0.001|TWO_SIDED|95.0|4.42|7.32||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, treatment-by-visit interaction, and geographic region, and the baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||7.32|4.42|<0.001
70947479|NCT02706951|141395374|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|19.8|||<|0.001|TWO_SIDED|95.0|12.8|26.8||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||26.8|12.8|<0.001
70947480|NCT02706951|141395374|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|32.1|||<|0.001|TWO_SIDED|95.0|24.6|39.7||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||39.7|24.6|<0.001
70947481|NCT02706951|141395375|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|-41.53||||0.001|TWO_SIDED|95.0|-66.56|-16.5||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, treatment-by-visit interaction, and geographic region, and the baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-16.50|-66.56|0.001
70947482|NCT02706951|141395375|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|-49.31|||<|0.001|TWO_SIDED|95.0|-74.23|-24.4||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, treatment-by-visit interaction, and geographic region, and the baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-24.40|-74.23|<0.001
70947483|NCT02706951|141395376|SUPERIORITY||Response Rate Difference|26.7|||<|0.001|TWO_SIDED|95.0|18.5|34.8||This comparison was not part of the pre-specified multiplicity testing sequence; the nominal p-value is reported.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||34.8|18.5|<0.001
70947484|NCT02706951|141395376|SUPERIORITY||Response Rate Difference|36.8|||<|0.001|TWO_SIDED|95.0|28.6|45.0||This comparison was not part of the pre-specified multiplicity testing sequence; the nominal p-value is reported.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||45.0|28.6|<0.001
70947485|NCT02706951|141395377|SUPERIORITY||Response Rate Difference|19.8|||<|0.001|TWO_SIDED|95.0|13.8|25.8||This comparison was not part of the pre-specified multiplicity testing sequence; the nominal p-value is reported.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||25.8|13.8|<0.001
70947486|NCT02706951|141395377|SUPERIORITY||Response Rate Difference|30.2|||<|0.001|TWO_SIDED|95.0|23.6|36.9||This comparison was not part of the pre-specified multiplicity testing sequence; the nominal p-value is reported.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||36.9|23.6|<0.001
70860752|NCT02117414|141207601|SUPERIORITY_OR_OTHER||Percentage|100.0|||<|0.0001|ONE_SIDED|95.0|97.75|||A priori threshold for statistical significance was 0.025.|one-proportion binomial exact test|||The alternative hypothesis is that the MRI-related event-free rate between the MRI procedure and one month post-MRI is greater than 90%. The null hypothesis will be rejected if the one-sided 97.5% lower confidence bound is greater than 90% or, equivalently, if the p-value is less than 0.025. Assuming type I error rate 0.025, even-free rate under null hypothesis 90% and true even-free rate 0.995, the minimum required sample size is 54 MRI scanned subjects in order to obtain 90% power.|||97.75|<0.0001
70860753|NCT02117414|141207602|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Difference in percentages|1.2|||<|0.0001|ONE_SIDED|95.0|-3.8|||A priori threshold for statistical significance was 0.025.|Farrington-Manning non-inferiority test|||"The percentage of subjects who experience a VPCT increase less than or equal to 0.5V from the pre-MRI/waiting period to one month post-MRI/waiting period in the MRI group is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group - 10% HA: % successes MRI group \> % successes Control group - 10%"|||-3.8|<0.0001
70947487|NCT03539068|141395385|SUPERIORITY||||||<|1e-05|||||||Chi-squared|||||||<0.00001
70947488|NCT01777334|141395387|SUPERIORITY_OR_OTHER||Least squares mean difference|0.112|||<|0.001|TWO_SIDED|95.0|0.081|0.144|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus TIO 18 µg.|||0.144|0.081|<0.001
70872111|NCT02155608|141229493|SUPERIORITY|||||||0.05||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = 3.95, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.05
70860754|NCT02117414|141207603|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 8%.|Difference in percentages|0.6||||0.0001|ONE_SIDED|95.0|-4.1|||A priori threshold for statistical significance was 0.025.|Farrington-Manning non-inferiority test|||"The percentage of subjects who do not experience a significant decrease in ventricular sensing amplitude from the pre-MRI/waiting period to one month post-MRI/waiting period is greater than that in the Control group minus 8%.~H0: % successes MRI group ≤ % successes Control group - 8% HA: % successes MRI group \> % successes Control group - 8%"|||-4.1|0.0001
70947489|NCT04599855|141395398|SUPERIORITY||least square (LS) means difference|-5.1|STANDARD_ERROR_OF_MEAN|1.42|<|0.001|TWO_SIDED|95.0|-7.91|-2.33|||Mixed model for repeated measures|||||-2.33|-7.91|<0.001
70947490|NCT04599855|141395398|SUPERIORITY||LS means difference|-6.8|STANDARD_ERROR_OF_MEAN|1.38|<|0.001|TWO_SIDED|95.0|-9.48|-4.07|||Mixed model for repeated measures|||||-4.07|-9.48|<0.001
70947491|NCT04599855|141395399|SUPERIORITY||LS means difference|-3.8|STANDARD_ERROR_OF_MEAN|1.29|=|0.004|TWO_SIDED|95.0|-6.29|-1.22|||Mixed model for repeated measures|||||-1.22|-6.29|=0.004
70947492|NCT04599855|141395399|SUPERIORITY||LS means difference|-3.4|STANDARD_ERROR_OF_MEAN|1.24|=|0.006|TWO_SIDED|95.0|-5.89|-1.0|||Mixed model for repeated measures|||||-1.00|-5.89|=0.006
70947493|NCT02165397|141395400|SUPERIORITY||Hazard Ratio (HR)|0.25|||<|0.0001|TWO_SIDED|95.0|0.148|0.42||The treatment effect was tested with a stratified log rank test.|Log Rank||The hazard ratio and its 95% confidence interval were based on a Cox regression model stratified by the randomization stratification factors.|||0.420|0.148|< 0.0001
70947494|NCT02165397|141395401|SUPERIORITY||Rate Ratio|2.526|||<|0.0001|TWO_SIDED|95.0|1.753|3.639||Response rate was compared using Cochran-Mantel-Haenszel (CMH) chi-square test.|Cochran-Mantel-Haenszel|||||3.639|1.753|< 0.0001
70947495|NCT02165397|141395402|SUPERIORITY||Hazard Ratio (HR)|0.102|||<|0.0001|TWO_SIDED|95.0|0.049|0.212||P-value is from a stratified log-rank test.|Log Rank||Hazard ratio is estimated using a stratified Cox regression model.|||0.212|0.049|< 0.0001
70947496|NCT02165397|141395403|SUPERIORITY||Rate Ratio|1.813|||<|0.0001|TWO_SIDED|95.0|1.357|2.421|||Chi-squared|||||2.421|1.357|< 0.0001
70947497|NCT02165397|141395404|SUPERIORITY||Rate Ratio|1.238||||0.1059|TWO_SIDED|95.0|0.955|1.603||CMH chi squared test|Cochran-Mantel-Haenszel|||||1.603|0.955|0.1059
70860755|NCT02117414|141207604|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis will be rejected if the one-sided 95% log-log transformed lower confidence bound at 120 days post-implant calculated using Kaplan-Meier (K-M) method is greater than 80%.|Complication-free rate|95.9|||<|0.0001|ONE_SIDED|95.0|93.0|||A priori threshold for statistical significance was 0.05.|Kaplan-Meier method|||"The system-related complication-free rate between the implant procedure and the one month post-MRI/waiting period is greater than 80%.~H0: p ≤ 0.80 HA: p \> 0.80 where p is the system-related complication-free rate between the implant procedure and 120 days (the approximate time of the one month post-MRI/waiting period visit)."|||93.0|<0.0001
70947498|NCT02165397|141395405|SUPERIORITY||Hazard Ratio (HR)|0.808||||0.643|TWO_SIDED|95.0|0.328|1.99||P-value is from unstratified log rank test.|Log Rank||Hazard ratio is estimated using unstratified Cox regression model with treatment as the only covariate.|Data cutoff 18 December 2019||1.99|0.328|0.643
70947499|NCT00424554|141395406|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||t-test, 2 sided|||||||0.09
70947500|NCT00236184|141395415|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared, Corrected|||||||<0.001
70947501|NCT01841697|141395417|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the two-sided 95% confidence interval for the mean difference between omarigilptin and sitagliptin is less than the non-inferiority margin, δ =0.3%, then omarigliptin will be declared non-inferior to sitagliptin in terms of A1C reduction at Week 24.|Difference in least squares mean|-0.03|||||TWO_SIDED|95.0|-0.15|0.08|||||Difference is omarigliptin minus sitagliptin.|Constrained longitudinal data analysis||0.08|-0.15|
70947502|NCT01841697|141395418|SUPERIORITY_OR_OTHER||Difference in percent|-4.3|||||TWO_SIDED|95.0|-11.8|3.2|||||Difference is omarigliptin minus sitagliptin.|||3.2|-11.8|
70947503|NCT01841697|141395419|SUPERIORITY_OR_OTHER||Difference in percent|-1.3|||||TWO_SIDED|95.0|-3.6|0.8|||||Difference is omarigliptin minus sitagliptin.|||0.8|-3.6|
70947504|NCT01841697|141395420|SUPERIORITY_OR_OTHER||Difference in least squares mean|-4.2||||0.089|TWO_SIDED|95.0|-9.0|0.6|||Constrained logitudinal data analysis|Terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups.|Difference is omarigliptin minus sitagliptin.|||0.6|-9.0|0.089
70947505|NCT01841697|141395421|SUPERIORITY_OR_OTHER||Between-group rate difference|2.0||||0.619|TWO_SIDED|95.0|-5.9|9.9|||Miettinen & Nurminen method|||Proportion (rate) for each group was estimated using standard multiple imputation techniques. Between-group difference in proportion is omarigliptin minus sitagliptin.||9.9|-5.9|0.619
70947506|NCT01841697|141395422|SUPERIORITY_OR_OTHER||Between-group rate difference|4.4||||0.212|TWO_SIDED|95.0|-2.5|11.4|||Miettinen & Nurminen method|||Proportion (rate) for each group was estimated using standard multiple imputation techniques. Between-group difference in proportion is omarigliptin minus sitagliptin.||11.4|-2.5|0.212
70947507|NCT00364377|141395448|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||Paired comparisons (within groups) to examine differences between the baseline study and after 8-weeks of treatment were made using Student's two-tailed t-test for paired samples. Between-group comparisons were made using Student's two-tailed t-test for unpaired samples. Given the previously observed variation in fasting glucose||||>0.05
70947508|NCT02818998|141395452|NON_INFERIORITY|Non-inferiority margin: 4 letters|Least Squares mean difference|0.01|||<|0.0001|TWO_SIDED|95.0|-1.46|1.47||Non-inferiority was demonstrated if the p-value (adjusted for multiplicity using the Hochberg procedure) was \< 0.025|ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||1.47|-1.46|<0.0001
70947509|NCT02818998|141395452|NON_INFERIORITY|Non-inferiority margin: 4 letters|Least Squares mean difference|0.95|||<|0.0001|TWO_SIDED|95.0|-0.52|2.42||Non-inferiority was demonstrated if the p-value (adjusted for multiplicity using the Hochberg procedure) was \< 0.025|ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||2.42|-0.52|<0.0001
70947510|NCT02818998|141395453|OTHER||Least Square mean difference|14.38||||0.0105|TWO_SIDED|95.0|3.39|25.37|||ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||25.37|3.39|0.0105
70947511|NCT02818998|141395453|OTHER||Least Square mean difference|21.22||||0.0023|TWO_SIDED|95.0|7.65|34.8|||ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||34.80|7.65|0.0023
70947512|NCT02818998|141395454|OTHER||Treatment Difference|0.68|||||TWO_SIDED|95.0|-3.14|4.49|||Cochran-Mantel-Haenszel|||≥ 15 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||4.49|-3.14|
70947513|NCT02818998|141395454|OTHER||Treatment Difference|2.66|||||TWO_SIDED|95.0|-3.4|8.73|||Cochran-Mantel-Haenszel|||≥10 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||8.73|-3.40|
70860756|NCT02117414|141207605|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 10%.|Difference in percentages|1.2|||<|1e-05|ONE_SIDED|90.0|-3.1|||A priori threshold for statistical significance was 0.05.|Farrington-Manning non-inferiority test|||"The percentage of subjects who have a defibrillation impedance between 20 and 100 ohms at the one month post-MRI/waiting period visit in the MRI group is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group - 10% HA: % successes MRI group \> % successes Control group - 10% Where % successes means the % of subjects whose defibrillation impedance at the one month post-MRI/waiting period visit is between 20 and 100 ohms."|||-3.1|<0.00001
70872112|NCT02155608|141229493|SUPERIORITY|||||||0.96||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 0.00, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.96
71132594|NCT01200368|141768221|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.29|||||TWO_SIDED|95.0|0.24|0.35||||||Serotype 3: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||0.35|0.24|
71132595|NCT01200368|141768221|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.28|||||TWO_SIDED|95.0|1.07|1.54||||||Serotype 5: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||1.54|1.07|
71132596|NCT01200368|141768221|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.76|||||TWO_SIDED|95.0|1.46|2.12||||||Serotype 6A: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||2.12|1.46|
71132597|NCT01200368|141768221|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.26|||||TWO_SIDED|95.0|1.04|1.52||||||Serotype 7F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||1.52|1.04|
71132598|NCT01200368|141768221|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.85|||||TWO_SIDED|95.0|1.54|2.24||||||Serotype 19A: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||2.24|1.54|
71132599|NCT01200368|141768222|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.3||||||Difference in percentage of participants achieving predefined antibody levels for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.||2.3|-2.4|
71132600|NCT01200368|141768222|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.3||||||Difference in percentage of participants achieving predefined antibody levels for tetanus toxoid and corresponding 2-sided 95% CI were calculated.||2.3|-2.4|
71132601|NCT01200368|141768222|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.3||||||Difference in percentage of participants achieving predefined antibody levels for pertussis toxoid and corresponding 2-sided 95% CI were calculated.||2.3|-2.4|
71132602|NCT01200368|141768222|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.3||||||Difference in percentage of participants achieving predefined antibody levels for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.||2.3|-2.4|
71132603|NCT01200368|141768223|SUPERIORITY_OR_OTHER||GMC ratio|1.1|||||TWO_SIDED|95.0|0.97|1.24||||||GMC ratio for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.||1.24|0.97|
71132604|NCT01200368|141768223|SUPERIORITY_OR_OTHER||GMC ratio|0.9|||||TWO_SIDED|95.0|0.77|1.06||||||GMC ratio for tetanus toxoid and corresponding 2-sided 95% CI were calculated.||1.06|0.77|
71132605|NCT01200368|141768224|SUPERIORITY_OR_OTHER||GMC ratio|0.98|||||TWO_SIDED|95.0|0.87|1.1||||||GMC ratio for pertussis toxoid and corresponding 2-sided 95% CI were calculated.||1.10|0.87|
70947514|NCT02818998|141395454|OTHER||Treatment Difference|-0.66|||||TWO_SIDED|95.0|-1.94|0.63|||Cochran-Mantel-Haenszel|||≥30 letter loss: Aflibercept 2 mg fixed was regarded as the reference arm||0.63|-1.94|
70947515|NCT02818998|141395454|OTHER||Treatment Difference|-0.13|||||TWO_SIDED|95.0|-3.68|3.41|||Cochran-Mantel-Haenszel|||≥15 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||3.41|-3.68|
70947516|NCT02818998|141395454|OTHER||Treatment Difference|1.72|||||TWO_SIDED|95.0|-4.1|7.54|||Cochran-Mantel-Haenszel|||≥10 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||7.54|-4.10|
70947517|NCT02818998|141395454|OTHER||Treatment Difference|-0.68|||||TWO_SIDED|95.0|-2.0|0.65|||Cochran-Mantel-Haenszel|||≥30 letter loss: Aflibercept 2 mg fixed was regarded as the reference arm||0.65|-2.00|
71132606|NCT01200368|141768224|SUPERIORITY_OR_OTHER||GMC ratio|0.92|||||TWO_SIDED|95.0|0.81|1.05||||||GMC ratio for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.||1.05|0.81|
71132607|NCT01200368|141768225|SUPERIORITY_OR_OTHER||GMC ratio|1.01|||||TWO_SIDED|95.0|0.88|1.15||||||GMC ratio for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.||1.15|0.88|
71132608|NCT01200368|141768225|SUPERIORITY_OR_OTHER||GMC ratio|1.0|||||TWO_SIDED|95.0|0.85|1.19||||||GMC ratio for tetanus toxoid and corresponding 2-sided 95% CI were calculated.||1.19|0.85|
71132609|NCT01200368|141768226|SUPERIORITY_OR_OTHER||GMC ratio|0.96|||||TWO_SIDED|95.0|0.84|1.11||||||GMC ratio for pertussis toxoid and corresponding 2-sided 95% CI were calculated.||1.11|0.84|
71132610|NCT01200368|141768226|SUPERIORITY_OR_OTHER||GMC ratio|0.8|||||TWO_SIDED|95.0|0.7|0.91||||||GMC ratio for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.||0.91|0.70|
70860757|NCT02117414|141207606|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 10%|Difference in percentages|0.0|||||TWO_SIDED|||||A priori threshold for statistical significance was 0.05. Because the success rate was 100% in each group, a p-value could not be calculated.|Farrington-Manning non-inferiority test|||"The percentage of subjects who have a SVC defibrillation impedance between 20 and 100 ohms at the one month post-MRI/waiting period visit in the MRI group is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group - 10% HA: % successes MRI group \> % successes Control group - 10% Where % successes means the % of subjects whose SVC defibrillation impedance at the one month post-MRI/waiting period visit is between 20 and 100 ohms."||||
71132611|NCT00570310|141768235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.42||||0.003||90.0|-2.25|-0.6||1-sided, alpha = 0.05|ANOVA||Primary Hypothesis: In 'primary responder population', pregabalin is superior to placebo in maintaining pain control measured by change (3-day average: end of the randomization period versus end of maintenance period) in evening pain intensity.|||-0.60|-2.25|0.003
71132612|NCT00570310|141768236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.67|||<|0.001||95.0|5.26|10.08||1-sided, alpha = 0.05|ANOVA|||||10.08|5.26|<0.001
71132613|NCT00108862|141768237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|3.0||0.45|TWO_SIDED|95.08|-2.0|8.0||The analysis was stratified by screening CD4 (\<50 cells/mm3 vs =\>50). Interim reviews employed group sequential monitoring using an O'Brien-Fleming use function. At final analysis, the a priori threshold for statistical significance was 0.0492.|Z-test, 2-sided|A 2-sided Z-test was used to compare the two percents. The test was weighted by the inverse of the Greenwood's variance in each CD4 stratum.|The difference in percents was calculated as the percent failed in the Deferred ART arm minus the percent failed in the Immediate ART arm.|Assuming that immediate ART was better than deferred ART and that the combined rate in the deferred ART arm was 25% compared to 15% in the immediate ART arm (a 40% reduction), and assuming 10% loss to follow-up in a two-sided, two-sample 0.05-level asymptotically-normal test with 400 participants in each arm, there was 90% power. The percents tested were Kaplan-Meier estimators at week 48 with the associated Greenwood's variance.||8|-2|0.45
71132614|NCT00108862|141768238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|5.0||0.02|TWO_SIDED|95.08|2.0|21.0||Interim reviews employed group sequential monitoring using an\> O'Brien-Fleming use function. At final analysis, the a priori threshold for statistical significance was 0.0492.|Z-test, 2-sided||The difference in percents was calculated as the percent failed in the Deferred ART arm minus the percent failed in the Immediate ART arm.|The study was not powered for this pre-specified subgroup analysis.||21|2|0.02
71132615|NCT00108862|141768239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|3.0||0.67|TWO_SIDED|95.08|-7.0|4.0||Interim reviews employed group sequential monitoring using an O'Brien-Fleming use function. At final analysis, the a priori threshold for statistical significance was 0.0492.|Z-test, 2-sided||The difference in percents was calculated as the percent failed in the Deferred ART arm minus the percent failed in the Immediate ART arm.|The study was not powered for this pre-specified subgroup analysis.||4|-7|0.67
71132616|NCT01664182|141768263|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.86||||||No adjustment for multiple comparisons. A-priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||Arm A vs Arm B shift test on Angiopoietin -- 2 prior to cycle 2. Wilcoxon rank-sum test p-value.||||0.86
71132617|NCT01664182|141768263|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.76||||||Angiopoietin -- 2 prior to cycle 3.|Wilcoxon (Mann-Whitney)|||Angiopoietin -- 2 prior to cycle 3||||0.76
71132618|NCT01664182|141768263|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.14||||||No adjustment for multiple comparison. A-priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||Tie--2 Prior to cycle 2||||0.14
71132619|NCT01664182|141768263|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.069||||||No adjustment for multiple comparisons. A-priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||Tie -- 2 prior to cycle 3||||0.069
71132620|NCT01664182|141768263|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.19||||||P-value is not adjusted for multiple comparisons. A-priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||VEGF -- A prior to cycle 2||||0.19
71132621|NCT01664182|141768263|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.046||||||P-value is not adjusted for multiple comparisons. The a-priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||VEGF--A prior to cycle 3||||0.046
71132622|NCT01664182|141768263|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.029||||||Not adjusted for multiple comparisons. A-priori threshold for statistical significance is 0.05|Wilcoxon (Mann-Whitney)|||PIGF Prior to Cycle 2||||0.029
71132623|NCT01664182|141768263|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.2||||||P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05|Wilcoxon (Mann-Whitney)|||PIGF prior to cycle 3||||0.20
71132624|NCT01664182|141768263|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.11||||||The p-value was not adjusted for multiple comparisons. The a-priori threshold for statistical significance is 0.05|Wilcoxon (Mann-Whitney)|||VEGFR--3 prior to cycle 2||||0.11
71132625|NCT01664182|141768263|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.068||||||P-value was not adjusted for multiple comparisons. The a-priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||VEGFR--3 prior to cycle 3||||0.068
71132626|NCT01664182|141768263|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.61||||||The p-value was not adjusted for multiple comparisons. The a-priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|||VEGF--C prior to cycle 2||||0.61
70860758|NCT02117414|141207607|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 10%.|Difference in percentages|-1.3||||0.006|ONE_SIDED|90.0|-7.0||||Farrington-Manning non-inferiority test|||"The percentage of subjects who experience an APCT increase less than or equal to 0.5V from the pre-MRI/waiting period to one month post-MRI/waiting period in the MRI group is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group - 10% HA: % successes MRI group \> % successes Control group - 10%"|||-7.0|0.006
70860759|NCT02117414|141207608|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 10%.|Difference in percentages|0.3||||0.005|ONE_SIDED|90.0|-6.2|||A priori threshold for statistical significance was 0.05|Farrington-Manning non-inferiority test|||"The percentage of subjects who do not experience a 50% decrease in atrial sensing amplitude from the pre-MRI/waiting period to one month post-MRI/waiting period is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group - 10% HA: % successes MRI group \> % successes Control group - 10%"|||-6.2|0.005
70860760|NCT00417482|141207609|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.94||||0.02|TWO_SIDED|95.0|1.09|3.45|||Stratified Cox analysis|||The primary hypothesis of a difference in survival functions between the initial Phase B placebo (Arm 3) and risperidone continuation (Arms 1+2) conditions was tested in the primary analysis using the stratified Cox analysis. For descriptive purposes, the overall rate of relapse was assessed as the number of follow-up or for secondary interpretative support, as a simple proportion of patients entering a 16-week period.||3.45|1.09|0.02
70860761|NCT00417482|141207610|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.88||||0.02|TWO_SIDED|95.0|1.08|21.98|||stratified cox analyses|||Similar analyses were used to test the secondary hypothesis in the relapse risk in weeks 17 to 32 of Phase B between the patients who continued to receive risperidone (Arm 1) \& the patients who discontinued risperidone at week 16 \& were switched to placebo (Arm 2). Patients who died \& those in whom a relapse was considered to be imminent before they were dropped out in Phase B were classified as having relapse.||21.98|1.08|0.02
70947518|NCT02818998|141395455|NON_INFERIORITY|Non-inferiority margin: 4 letters|Least Squares mean difference|-0.3|||<|0.0001|TWO_SIDED|95.0|-2.13|1.52|||ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||1.52|-2.13|<0.0001
70947519|NCT02818998|141395455|NON_INFERIORITY|Non-inferiority margin: 4 letters|Least Squares mean difference|1.39|||<|0.0001|TWO_SIDED|95.0|-0.4|3.19|||ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||3.19|-0.40|<0.0001
70947520|NCT02818998|141395456|OTHER||Least Square mean difference|16.14||||0.0416|TWO_SIDED|95.0|0.62|31.66|||ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||31.66|0.62|0.0416
70947521|NCT02818998|141395456|OTHER||Least Square mean difference|4.12||||0.5524|TWO_SIDED|95.0|-9.52|17.77|||ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||17.77|-9.52|0.5524
70947522|NCT02818998|141395457|OTHER||Treatment Difference|0.67|||||TWO_SIDED|95.0|-2.72|4.05|||Cochran-Mantel-Haenszel|||≥ 15 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||4.05|-2.72|
70947523|NCT02818998|141395457|OTHER||Treatment Difference|4.63|||||TWO_SIDED|95.0|-1.73|10.98|||Cochran-Mantel-Haenszel|||≥10 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||10.98|-1.73|
70947524|NCT02818998|141395457|OTHER||Treatment Difference|0.66|||||TWO_SIDED|95.0|-1.56|2.87|||Cochran-Mantel-Haenszel|||≥30 letter loss: Aflibercept 2 mg fixed was regarded as the reference arm||2.87|-1.56|
70860762|NCT00417482|141207611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.36||0.08|TWO_SIDED|95.0|-0.08|1.35|||t-test, 2 sided|||The null hypothesis is that there is no difference between the risperidone and placebo groups over the 16 week period post randomization, with respect to change in MMSE.||1.35|-0.08|0.08
70860763|NCT00417482|141207612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.49||0.94||95.0|-1.01|0.93|||t-test, 2 sided|||The null hypothesis is that there is no difference between the risperidone and placebo groups over the 16 week period post randomization, with respect to change in TESS.||0.93|-1.01|0.94
70947525|NCT02818998|141395457|OTHER||Treatment Difference|1.9|||||TWO_SIDED|95.0|-1.89|5.69|||Cochran-Mantel-Haenszel|||≥15 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||5.69|-1.89|
70947526|NCT02818998|141395457|OTHER||Treatment Difference|7.54|||||TWO_SIDED|95.0|0.81|14.28|||Cochran-Mantel-Haenszel|||≥10 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||14.28|0.81|
70947527|NCT02818998|141395457|OTHER||Treatment Difference|0.63|||||TWO_SIDED|95.0|-1.61|2.88|||Cochran-Mantel-Haenszel|||≥30 letter loss: Aflibercept 2 mg fixed was regarded as the reference arm||2.88|-1.61|
70947528|NCT00632021|141395460|EQUIVALENCE|In the primary analysis we compared the number of clinically important medication errors by treatment group using unadjusted negative binomial regression.|Incidence Rate Ratio (IRR)|0.92|||||TWO_SIDED|95.0|0.77|1.09||||||||1.09|0.77|
70947529|NCT00632021|141395461|EQUIVALENCE|The association between intervention and time to first unplanned health care event (hospital readmission) was examined using multivariable Cox proportional hazards regression models.|Cox Proportional Hazard|0.94|||||TWO_SIDED|95.0|0.63|1.28||||||||1.28|0.63|
70947530|NCT00458393|141395462|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.577|STANDARD_ERROR_OF_MEAN|0.105||0.002|TWO_SIDED|95.0|0.404|0.824||secondary p-value given.|Log Rank|stratified by site|Efron correction for ties. Placebo is reference. Results typically quoted as efficacy = 100\*(1-HR)|Primary null hypothesis: Relative hazard of 0.7 or less. Secondary null hypothesis: Relative hazard of 1.0 or less.||.824|.404|0.002
70947531|NCT00458393|141395463|SUPERIORITY||Risk Ratio (RR)|1.33||||0.28|TWO_SIDED|95.0|0.79|2.25||p-value is not adjusted for multiple comparisons, a priori threshold for statistical significance was p \< 0.05|Fisher Exact||||Extensive analysis and methods published in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3966916/|2.25|0.79|0.28
70947532|NCT00458393|141395464|SUPERIORITY||Risk Ratio (RR)|1.3||||0.54|TWO_SIDED|95.0|0.57|2.96|||Fisher Exact|||||2.96|.57|0.54
70947533|NCT00458393|141395465|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.5|TWO_SIDED|95.0|0.65|1.23|||Log Rank|||||1.23|0.65|0.50
70947534|NCT00458393|141395466|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.92|TWO_SIDED|95.0|0.79|1.23|||Log Rank|||||1.23|0.79|0.92
70947535|NCT00458393|141395467|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Null hypothesis of no difference||||1.00
70947536|NCT00458393|141395467|SUPERIORITY|Desc|Risk Difference (RD)|0.0||||1|TWO_SIDED||||||Fisher Exact|||||||1.00
70947537|NCT00458393|141395468|SUPERIORITY||Mean Difference (Net)|-0.91||||0.001|TWO_SIDED|||||\< 0.05 for statistical significance. no adjustment for multiple comparisons|Mixed Models Analysis|||||||0.001
70947538|NCT00458393|141395469|SUPERIORITY||Median Difference (Net)|-3.8||||0.009|TWO_SIDED|95.0|-6.6|-0.95|||median regression|||||-0.95|-6.6|0.009
71132627|NCT01664182|141768263|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.27||||||Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.|Wilcoxon (Mann-Whitney)|||VEGF--C prior to cycle 3||||0.27
71132628|NCT01664182|141768263|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.61||||||The p-value was not adjusted for multiple comparisons. The a-priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||IL--8 prior to cycle 2||||0.61
71132629|NCT01664182|141768263|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.49||||||The p-value was not adjusted for multiple comparisons, and the a-priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|||IL--8 prior to cycle 3||||0.49
71132630|NCT01664182|141768263|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.82||||||The p-value was not adjusted for multiple comparisons. The a-priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||ICAM--1 prior to cycle 2||||0.82
71132631|NCT01664182|141768263|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.069||||||The p-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||ICAM--1 prior to cycle 3||||0.069
71132632|NCT01664182|141768263|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.34||||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||VCAM--1 prior to cycle 2||||0.34
71132633|NCT01664182|141768263|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.046||||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was set to 0.05.|Wilcoxon (Mann-Whitney)|||VCAM--1 prior to cycle 3||||0.046
71132634|NCT01664182|141768263|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.11||||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was set to 0.05.|Wilcoxon (Mann-Whitney)|||FGF2 prior to cycle 2||||0.11
71132635|NCT01664182|141768263|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.23||||||The p-value was adjusted for multiple comparisons. The a prior threshold for statistical significance was set to 0.05.|Wilcoxon (Mann-Whitney)|||FGF2 prior to cycle 3||||0.23
71132636|NCT01664182|141768263|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.37||||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was set to 0.05.|Wilcoxon (Mann-Whitney)|||PDGF--AA prior to cycle 2||||0.37
71132637|NCT01664182|141768263|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.35||||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was set to 0.05.|Wilcoxon (Mann-Whitney)|||PDGF--AA prior to cycle 3||||0.35
70947539|NCT00458393|141395470|SUPERIORITY||Median Difference (Net)|0.0||||1|TWO_SIDED|95.0|-9.3|9.3|||median regression|||||9.3|-9.3|1.00
70947540|NCT00458393|141395471|SUPERIORITY||Median Difference (Net)|-2.2||||0.19|TWO_SIDED|95.0|-5.5|1.1|||median regression|||||1.1|-5.5|0.19
71132638|NCT02881762|141768271|OTHER|Comparison of mean change analyzed with unpaired t-test for parametric data. The test was performed with a significance level of 0.05 (two-sided).||||||0.13|||||||t-test, 2 sided|||Null hypothesis is that there is no difference in change in HCV viral load between Maraviroc and No Maraviroc||||0.13
71132639|NCT02881762|141768272|OTHER|Comparison of difference in mean analyzed with paired t-test for parametric data. The test was performed with a significance level of 0.05 (two-sided).|||||>|0.5|||||||t-test, 2 sided|||Null hypothesis is that there is no difference in HCV viral load between baseline and 7 days of maraviroc.||||>0.5
71132640|NCT01702246|141768321|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||Wilcoxon matched pairs signed rank test|Wilcoxon (Mann-Whitney)|||||||0.005
71132641|NCT01702246|141768322|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|||||||0.003
71132642|NCT01702246|141768323|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
71132643|NCT04607837|141768438|SUPERIORITY||Risk Difference (RD)|7.35||||0.2524|TWO_SIDED|95.0|-5.24|19.94|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common risk difference using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the risk difference being 0.||19.94|-5.24|0.2524
71132644|NCT04607837|141768439|SUPERIORITY||Risk Difference (RD)|15.61||||0.0068|TWO_SIDED|95.0|4.31|26.91|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||26.91|4.31|0.0068
71132645|NCT04607837|141768440|SUPERIORITY||Risk Difference (RD)|8.24||||0.2302|TWO_SIDED|95.0|-5.22|21.71|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||21.71|-5.22|0.2302
70947541|NCT00458393|141395472|SUPERIORITY||Mean Difference (Net)|0.08||||0.56|TWO_SIDED|95.0|-0.18|0.33|||t-test, 2 sided|||||0.33|-.18|0.56
70947542|NCT00458393|141395473|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.0||||1|TWO_SIDED||||||Fisher Exact|||Null hypothesis is the proportion of mutations is identical.|Detailed resistance data is found at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4176446/|||1.00
70947543|NCT00458393|141395474|SUPERIORITY||Mean Difference (Net)|-7.0||||0.32|TWO_SIDED|95.0|-69.0|54.0|||Mixed Models Analysis|||||54|-69|0.32
70947544|NCT00458393|141395475|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.005||||0.53|TWO_SIDED|95.0|-0.02|0.01|||Mixed Models Analysis|||Null hypothesis is equal proportion of pills returned||0.01|-0.02|0.53
70947545|NCT00458393|141395476|SUPERIORITY||Mean Difference (Net)|0.25||||0.7|TWO_SIDED|95.0|-1.1|1.6|||t-test, 2 sided||||Detailed methods and results are available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4110718/|1.6|-1.1|0.70
70947546|NCT00458393|141395477|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED|||||Not adjusted for multiple comparisons and the a priori threshold for statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.99
70947547|NCT00458393|141395478|SUPERIORITY||Median Difference (Final Values)|0.0||||0.76|TWO_SIDED|95.0|-0.42|0.42||Not adjusted for multiple comparisons, a priori threshold for statistical significance, p \< 0.05|Wilcoxon (Mann-Whitney)||||Full details available in the methods section of https://www.ncbi.nlm.nih.gov/pubmed/24367497|.42|-.42|0.76
70947548|NCT00458393|141395479|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-0.008||||0.68|TWO_SIDED|95.0|-0.047|0.03|||Chi-squared|||Null is no difference between arms||0.030|-0.047|0.68
70947549|NCT00458393|141395480|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.13||||0.3|TWO_SIDED|95.0|0.89|1.43|||Log Rank|||Null hypothesis of no difference between the arms||1.43|0.89|0.30
70860764|NCT00417482|141207613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.48||0.26|TWO_SIDED|95.0|-1.5|0.41|||t-test, 2 sided|||The null hypothesis is that the difference between placebo and risperidone groups in terms of mean change in EPS, between randomization and week 16, is zero.||0.41|-1.50|0.26
70860765|NCT00417482|141207614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.14||0.13|TWO_SIDED|95.0|-0.5|0.07|||t-test, 2 sided|||The null hypothesis is that the difference between placebo and risperidone groups in terms of mean change in AIMS, between randomization and week 16, is zero.||0.07|-0.50|0.13
70860766|NCT00417482|141207615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.43||0.149|TWO_SIDED|95.0|-1.47|0.23|||t-test, 2 sided|||The null hypothesis is that the difference between placebo and risperidone groups in terms of mean change in PSMS, between randomization and week 16, is zero.||0.23|-1.47|0.149
70947550|NCT00458393|141395481|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.41|TWO_SIDED|95.0|0.8|1.7|||Log Rank||||Details in the manuscript https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3956614/|1.7|0.8|0.41
70947551|NCT00458393|141395482|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.09|TWO_SIDED|95.0|0.34|1.09|||Log Rank|||||1.09|0.34|0.09
70947552|NCT05043883|141395505|SUPERIORITY|This clinical investigation is intended to demonstrate that the performance of the PVI Analyzer software is superior to clinically relevant performance level, and therefore the study is designed as a 1-sample superiority test of the sampled outcome specificity. The lower bound 95% CI (α=0.05) and at a statistical power of 95% (β=0.05).|Percentage (%)|87.0||||0.006|ONE_SIDED|95.0||||The success of the PVI Analyzer output was assumed to follow a binominal distribution with a given true proportion of 87.50%. It was tested whether the specificity was superior to the 80% limit.|Z-test|A one-tailed test with a significance level of 95% (α = 0.05) was applied.||Specificity is the ability to correctly detect true negative values of the ground-truth negative EGM classifications. The PVI Analyzer software classifies an EGM in positive (isolated) or negative (non-isolated), compared to the SOC outcomes. EGMs prior-isolation were labeled as ground-truth negative (non-isolated), EGMs after isolation as ground-truth positive (isolated). The null hypothesis is that specificity is lower or equal to the superiority limit 80%.||||0.006
70947553|NCT05043883|141395505|SUPERIORITY|This clinical investigation is intended to demonstrate that the performance of the PVI Analyzer software is superior to clinically relevant performance level, and therefore the study is designed as a 1-sample superiority test of the sampled outcome Sensitivity. The lower bound 95% CI (α=0.05) and at a statistical power of 95% (β=0.05).|Percentage|86.0||||0.004|ONE_SIDED|95.0||||The success of the PVI Analyzer output was assumed to follow a binominal distribution with a given true proportion of 87.50%. It was tested whether the sensitivity was superior to the 80% limit.|Z-test|A one-tailed test with a significance level of 95% (α = 0.05) was applied.||Sensitivity of the PVI analyzer is determined by the capability to detect true positive among all ground-truth positive EGM classifications.The PVI Analyzer software classifies an EGM in positive (isolated) or negative (non-isolated), compared to the SOC outcomes. EGMs prior-isolation were labeled as ground-truth negative (non-isolated), EGMs after isolation as ground-truth positive (isolated). The null hypothesis is that sensitivity is lower or equal to the superiority limit 80%.||||0.004
70947554|NCT05043883|141395506|OTHER|Descriptive|Percentage|0.99|STANDARD_DEVIATION|0.1|||TWO_SIDED|95.0|0.02|5.39|||||Only one AE was reported for one subject ( which was considered moderate in severity and not related to the device, but related to the SOC procedure.|A descriptive analysis was performed to evaluate the AEs and device deficiencies, estimating the percentages and 95% CI on each category.||5.39|0.02|
71132646|NCT04607837|141768441|SUPERIORITY||Risk Difference (RD)|7.12||||0.3339|TWO_SIDED|95.0|-7.32|21.55|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||21.55|-7.32|0.3339
71132647|NCT04607837|141768442|SUPERIORITY||Risk Difference (RD)|0.68||||0.9141|TWO_SIDED|95.0|-11.76|13.13|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||13.13|-11.76|0.9141
71132648|NCT04607837|141768443|SUPERIORITY||Risk Difference (RD)|9.56||||0.1089|TWO_SIDED|95.0|-2.13|21.25|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||21.25|-2.13|0.1089
71132649|NCT04607837|141768444|SUPERIORITY||Risk Difference (RD)|11.19||||0.0104|TWO_SIDED|95.0|2.63|19.75|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||19.75|2.63|0.0104
71132650|NCT04607837|141768445|SUPERIORITY||Risk Difference (RD)|-1.07||||0.9203|TWO_SIDED|95.0|-22.06|19.92|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||19.92|-22.06|0.9203
71132651|NCT04607837|141768446|SUPERIORITY||Risk Difference (RD)|8.49||||0.1726|TWO_SIDED|95.0|-3.71|20.68|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||20.68|-3.71|0.1726
71132652|NCT04607837|141768447|SUPERIORITY||Risk Difference (RD)|-1.71||||0.9272|TWO_SIDED|95.0|-38.31|34.9|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||34.90|-38.31|0.9272
71132653|NCT04607837|141768448|SUPERIORITY||Risk Difference (RD)|8.49||||0.1726|TWO_SIDED|95.0|-3.71|20.68|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||20.68|-3.71|0.1726
70872113|NCT02155608|141229493|SUPERIORITY|||||||0.92||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .01, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.92
71132654|NCT04607837|141768449|SUPERIORITY||Risk Difference (RD)|18.64||||0.0151|TWO_SIDED|95.0|3.61|33.67|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||33.67|3.61|0.0151
71132655|NCT04607837|141768450|SUPERIORITY||Risk Difference (RD)|5.96||||0.4419|TWO_SIDED|95.0|-9.22|21.13|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||21.13|-9.22|0.4419
71132656|NCT04607837|141768451|SUPERIORITY||Risk Difference (RD)|23.33||||0.0007|TWO_SIDED|95.0|9.78|36.89|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||36.89|9.78|0.0007
71132657|NCT04607837|141768452|SUPERIORITY||Risk Difference (RD)|14.99||||0.0128|TWO_SIDED|95.0|3.19|26.79|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||26.79|3.19|0.0128
71132658|NCT04607837|141768453|SUPERIORITY||Risk Difference (RD)|10.24||||0.1492|TWO_SIDED|95.0|-3.67|24.14|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||24.14|-3.67|0.1492
71132659|NCT04607837|141768454|SUPERIORITY||Risk Difference (RD)|0.18||||0.9774|TWO_SIDED|95.0|-12.18|12.53|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||12.53|-12.18|0.9774
70947555|NCT05043883|141395507|SUPERIORITY||Percentage (%)|94.0||||2e-05|TWO_SIDED|||||Computed p values are the result of running a one sample z-test with a null hypothesis that specificity is below 80%.|Z-test|||Automated PVI Analyzer classification of PV isolation in SR by Radiofrequency procedure from EP procedure until study completion at discharge (an average of 24 hours), with a specificity superior to 80%. A superiority Z-test for Specificity was performed.||||0.00002
70947556|NCT05043883|141395507|SUPERIORITY||Percentage (%)|82.0||||0.32|TWO_SIDED|||||Computed p values are the result of running a one sample z-test with a null hypothesis that sensitivity is below 80% and alternative hypothesis that sensitivity is at or above 80%.|Z-test|||Automated PVI Analyzer classification of PV isolation in SR by Radiofrequency procedure from EP procedure until study completion at discharge (an average of 24 hours), with sensitivity superior to 80%. A superiority Z-test for Sensitivity was performed.||||0.32
70947557|NCT05043883|141395507|SUPERIORITY||Percentage (%)|79.0||||0.66|TWO_SIDED|||||Computed p values are the result of running a one sample z-test with a null hypothesis that specificity is below 80%.|Z-test|||Automated PVI Analyzer classification of PV isolation in SR by Cryo-balloon procedure from EP procedure until study completion at discharge (an average of 24 hours), with a specificity superior to 80%. A superiority Z-test for Specificity was performed.||||0.66
70947558|NCT05043883|141395507|SUPERIORITY||Percentage (%)|92.0||||0.0008|TWO_SIDED|||||Computed p values are the result of running a one sample z-test with a null hypothesis that sensitivity is below 80% and alternative hypothesis that sensitivity is at or above 80%.|Z-test|||Automated PVI Analyzer classification of PV isolation in SR by Cryo-balloon procedure from EP procedure until study completion at discharge (an average of 24 hours), with a sensitivity superior to 80%. A superiority Z-test for Sensitivity was performed.||||0.0008
70947559|NCT05043883|141395508|SUPERIORITY||Percentage (%)|96.0||||5e-06|TWO_SIDED|||||To compute the proportional agreement between two non-overlapping samples, a one-sample Z-test was performed with the alternative hypothesis that agreement was above 90%, which was considered sufficient for a real-time assessment.|Z-test|||This endpoint used the same EGMs extracted for the primary endpoint, including only EGMs from T Baseline and T Final measurements from patients in sinus rhythm.||||0.000005
71132660|NCT04607837|141768455|SUPERIORITY||Risk Difference (RD)|22.83||||0.0011|TWO_SIDED|95.0|9.17|36.49|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||36.49|9.17|0.0011
71132661|NCT04607837|141768456|SUPERIORITY||Risk Difference (RD)|10.8||||0.1513|TWO_SIDED|95.0|-3.95|25.56|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||25.56|-3.95|0.1513
70860767|NCT00417482|141207616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|1.69||0.81|TWO_SIDED|95.0|-3.77|2.95|||t-test, 2 sided|||The null hypothesis is that the difference between placebo and risperidone groups in terms of mean change in weight, between randomization and week 16, is zero.||2.95|-3.77|0.81
70872114|NCT02155608|141229494|SUPERIORITY|||||||0.79||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .07, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.79
71132662|NCT04607837|141768457|SUPERIORITY||Risk Difference (RD)|10.07||||0.1823|TWO_SIDED|95.0|-4.73|24.87|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||24.87|-4.73|0.1823
71132663|NCT04346654|141768466|SUPERIORITY|||||||0.5133|||||||Regression, Logistic|||||||0.5133
71132664|NCT04346654|141768467|SUPERIORITY|||||||0.5133|||||||Regression, Logistic|||||||0.5133
71132665|NCT02915978|141768491|OTHER||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.89||0.0505|TWO_SIDED|95.0|-3.61|0.0|||ANCOVA|||NRS PID at 1 hour||0.00|-3.61|0.0505
71132666|NCT02915978|141768491|OTHER||LS Mean Difference|-1.06|STANDARD_ERROR_OF_MEAN|0.9||0.2493|TWO_SIDED|95.0|-2.89|0.77|||ANCOVA|||NRS PID at 1 hour||0.77|-2.89|0.2493
71132667|NCT02915978|141768491|OTHER||LS Mean Difference|-2.94|STANDARD_ERROR_OF_MEAN|0.99||0.0052|TWO_SIDED|95.0|-4.95|-0.94|||ANCOVA|||NRS PID at 16 hours||-0.94|-4.95|0.0052
71132668|NCT02915978|141768491|OTHER||LS Mean Difference|-1.67|STANDARD_ERROR_OF_MEAN|0.97||0.0926|TWO_SIDED|95.0|-3.62|0.29|||ANCOVA|||NRS PID at 16 hours||0.29|-3.62|0.0926
71132669|NCT02915978|141768491|OTHER||LS Means Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.82||0.0951|TWO_SIDED|95.0|-3.06|0.26|||ANCOVA|||NRS PID at 24 hours||0.26|-3.06|0.0951
70872115|NCT02155608|141229494|SUPERIORITY|||||||0.3||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 1.10, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.30
71132670|NCT02915978|141768491|OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.8||0.9866|TWO_SIDED|95.0|-1.6|1.63|||ANCOVA|||NRS PID at 24 hours||1.63|-1.60|0.9866
71132671|NCT02343406|141768519|OTHER||Cox Proportional Hazard|0.71|||=|0.062|TWO_SIDED|95.0|0.5|1.02||2-sided|Log Rank|||Stratified at randomization by regions of the world (North America, Europe and Australia, Asia/Other Regions), WHO performance status (0, \> 0), timing of relapse (\< 16 weeks, ≥ 16 weeks after first day of last TMZ cycle).||1.02|0.5|= 0.062
71132672|NCT02343406|141768519|OTHER||Cox Proportional Hazard|1.04|||=|0.835|TWO_SIDED|95.0|0.73|1.48||2-sided|Log Rank|||Stratified at randomization by regions of the world (North America, Europe and Australia, Asia/Other Regions), WHO performance status (0, \> 0), timing of relapse (\< 16 weeks, ≥ 16 weeks after first day of last TMZ cycle).||1.48|0.73|= 0.835
71132673|NCT02343406|141768520|OTHER||Cox Proportional Hazard|0.77|||=|0.123|TWO_SIDED|95.0|0.55|1.07||2-sided|Log Rank|||||1.07|0.55|= 0.123
71132674|NCT02343406|141768520|OTHER||Cox Proportional Hazard|1.31|||=|0.117|TWO_SIDED|95.0|0.93|1.84||2-sided|Log Rank|||||1.84|0.93|= 0.117
71132675|NCT02343406|141768528|OTHER||Odds Ratio (OR)|3.1|||=|0.06|TWO_SIDED|95.0|0.6|16.16||2-sided|Cochran-Mantel-Haenszel|||Comparison is based on Cochran-Mantel-Haenszel method with stratification factors. Stratified at randomization by regions of the world (North America, Europe and Australia, Asia/Other Regions), WHO performance status (0, \> 0), timing of relapse (\< 16 weeks, ≥ 16 weeks after first day of last TMZ cycle).||16.16|0.6|= 0.06
71132676|NCT02343406|141768528|OTHER||Odds Ratio (OR)|1.21|||=|0.767|TWO_SIDED|95.0|0.12|12.49||2-sided|Cochran-Mantel-Haenszel|||Comparison is based on Cochran-Mantel-Haenszel method with stratification factors. Stratified at randomization by regions of the world (North America, Europe and Australia, Asia/Other Regions), WHO performance status (0, \> 0), timing of relapse (\< 16 weeks, ≥ 16 weeks after first day of last TMZ cycle).||12.49|0.12|= 0.767
71132677|NCT02343406|141768529|OTHER||Cox Proportional Hazard|0.67|||=|0.127|TWO_SIDED|95.0|0.4|1.13||2-sided|Log Rank|||||1.13|0.4|= 0.127
71132678|NCT02343406|141768529|OTHER||Cox Proportional Hazard|0.88|||=|0.64|TWO_SIDED|95.0|0.52|1.49||2-sided|Log Rank|||||1.49|0.52|= 0.64
71132679|NCT00766051|141768543|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.0|STANDARD_ERROR_OF_MEAN|1.76|<|0.005|TWO_SIDED|95.0|5.0|11.0||The P value is not adjusted for multiple comparisons or for statistical significance|t-test, 2 sided|||The expected outcome was that infants in the intervention group would exhibit significantly less number of days to attain oral feeding.||11|5|<0.005
71132680|NCT00766051|141768544|SUPERIORITY_OR_OTHER||Slope|0.275|||<|0.01|||||||Mixed Models Analysis|This correlation is between the intervention groups' initial level of relaxation and final level of relaxation during the oral feeding period.||Pearson Correlation, 2-tailed||||< 0.01
71132681|NCT00766051|141768545|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.6|STANDARD_DEVIATION|5.2|<|0.02|ONE_SIDED|95.0||6.7|||t-test, 1 sided||An increase in this test scale score means more parent confidence.|"Parent pre-post one sided t test of parents' global confidence, measured parental confidence in feeding, handling, and interacting with their infant."||6.7||< .02
71132682|NCT00766051|141768546|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.8|STANDARD_DEVIATION|4.3|<|0.03|ONE_SIDED|95.0||4.54|||t-test, 1 sided||An increase in this test scale score means an increase in the parents' perception of their infants' easiness during caregiving.|Parent pre-post one sided t test on the Easiness Scale of the Mother and Baby Scales in how parents percieve their interactions (alert-responsiveness, mood) with their infant and infant sleep patterns .||4.54||< .03
71145826|NCT02977403|141785387|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.015|||||TWO_SIDED|95.0|-0.061|0.091||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.091|-0.061|
71145827|NCT02977403|141785387|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.108|||||TWO_SIDED|95.0|-0.26|0.044||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.044|-0.260|
70947560|NCT05043883|141395509|SUPERIORITY||Percentage (%)|54.0||||1|TWO_SIDED|||||The p values calculated are the result of running a one sample z-test with a null hypothesis that the specificity are below 80%.|Z-test|||The data analysis and processing were similar to those of the primary endpoint, but taking into consideration that subjects shall be in non-sinus rhythm during the duration of the EGM snippet. Apart from this, the processing was the same and the threshold was also defined as 50: values below 50 were classified as baseline, while values at or above 50 were considered as isolated veins.||||1
70947561|NCT05043883|141395509|SUPERIORITY||Percentage (%)|100.0||||0.0007|TWO_SIDED|||||The p values calculated are the result of running a one sample z-test with a null hypothesis that the sensitivity are below 80% and an alternative hypothesis that sensitivity is at or above 80%.|Z-test|||The data analysis and processing were similar to those of the primary endpoint, but taking into consideration that subjects shall be in non-sinus rhythm during the duration of the EGM snippet. Apart from this, the processing was the same and the threshold was also defined as 50: values below 50 were classified as baseline, while values at or above 50 were considered as isolated veins.||||0.0007
71132683|NCT03058692|141768552|OTHER|||||||0.53||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.53
70860768|NCT05402020|141207617|OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.87|1.15|||||Ratio calculated as \[Tio/Olo\]/\[ICS/LABA\]|Univariate proportional hazards regression was used to compare the time to event (first moderate or severe COPD exacerbations) between the two treatment groups. In the event that there were baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) were included in a multiple regression model in addition to the exposure status (Tio/Olo or ICS/LABA).||1.15|0.87|
70947562|NCT05043883|141395510|SUPERIORITY||Percentage (%)|87.0||||0.04|TWO_SIDED||||||Z-test|The estimate was done using a one-sample Z-test with a null hypothesis that sensitivity is at or below 80% and a 95% significance level.||This secondary endpoint aimed to determine the sensitivity of the PVI Analyzer at the time of isolation, which requires the EGMs at the T PVI. A Z-test for sensitivity was performed to assess the sensitivity of the PVI Analyzer analysis to identify expert-defined isolation during the PVI ablation.||||0.04
70947563|NCT05043883|141395511|OTHER|||||||0.0002||||||McNemar test assumes as a null hypothesis that the two datasets cause the PVI Analyzer to have a similar proportion of errors.|McNemars test|A paired McNemars test with an alpha value of 0.05, was applied to analyze the differences in classification performance.||A paired McNemar's Chi-Square test was performed to analyze the differences in classification performances||||0.0002
70947564|NCT01587118|141395512|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The a priori threshold for statistical significance was p\</= 0.05|ANOVA|Change from baseline analyses were conducted using simple one-way analysis of variance; and were recalculated using the Kruskal Wallis procedure.||||||<.0001
70947565|NCT01587118|141395513|SUPERIORITY_OR_OTHER|||||||0.0006||||||The a priori threshold for statistical significance was p\</= 0.05|ANOVA|Change from baseline analyses were conducted using simple one-way analysis of variance; and were recalculated using the Kruskal Wallis procedure.||||||.0006
70860769|NCT05402020|141207618|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.53|0.85|||||Ratio calculated as \[Tio/Olo\]/\[ICS/LABA\]|Univariate proportional hazards regression was used to compare the time to event (triple therapy escalation) between the two treatment groups. In the event that there were baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) were included in a multiple regression model in addition to the exposure status (Tio/Olo or ICS/LABA).||0.85|0.53|
70860770|NCT05402020|141207619|OTHER||Incidence difference|-37.9|||||TWO_SIDED|95.0|-60.1|-15.8|||||Incidence difference calculated as \[incidence rate of Tio/Olo\]-\[incidence rate of ICS/LABA\].|The rate ratio of Tio+Olo - exposed group relative to LABA/ICS group, along with 95% CIs were derived using a univariate negative binomial model. In the event that there are baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) will be included in a multiple regression model in addition to the exposure status (Tio/Olo or LABA/ICS).||-15.8|-60.1|
70947566|NCT01586975|141395515|SUPERIORITY_OR_OTHER|||||||0.0742|TWO_SIDED|||||p-value is not adjusted, and no a priori threshold was used|Kruskal-Wallis|||Kruskal-Wallis non-parametric ANOVA test||||0.0742
70947567|NCT00243022|141395523|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||t-test, 2 sided|||||||0.9
70947568|NCT00243022|141395524|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||t-test, 2 sided|||||||0.12
70947569|NCT00243022|141395525|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||t-test, 2 sided|||||||0.8
70860771|NCT05402020|141207619|OTHER||Incidence Rate Ratio|0.66|||||TWO_SIDED|95.0|0.51|0.85|||||Ratio calculated as \[incidence rate of Tio/Olo\]/\[incidence rate of ICS/LABA\].|The rate ratio of Tio+Olo - exposed group relative to LABA/ICS group, along with 95% CIs were derived using a univariate negative binomial model. In the event that there are baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) will be included in a multiple regression model in addition to the exposure status (Tio/Olo or LABA/ICS).||0.85|0.51|
70947570|NCT01390441|141395531|NON_INFERIORITY_OR_EQUIVALENCE|PK bioequivalence was assumed if the 90% confidence interval of the geometric mean ratio for the comparison fell within the range 0.80-1.25.|Geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.87|1.16|||ANOVA|||Back-transformed least squares mean and confidence interval from fixed effects model performed on natural log-transformed values containing treatment as a fixed effect and gender as a covariate.||1.16|0.87|
70872116|NCT02155608|141229494|SUPERIORITY|||||||0.03||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 4.61, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.03
70947571|NCT01390441|141395533|SUPERIORITY_OR_OTHER||Percent difference|-17.2|||||TWO_SIDED|95.0|-38.6|3.6|||Miettinen-Nurminen|||The difference in percent AE incidence was determined for the treatment comparison (Part A: MK-8808 500 mg/m\^2 - Part A: MabThera 500 mg/m\^2) when \>=4 participants in an arm experienced an event.||3.6|-38.6|
70860772|NCT05402020|141207620|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.36|1.93|||||Ratio calculated as \[Tio/Olo\]/\[ICS/LABA\]|Univariate proportional hazards regression was used to compare the time to event (first hospitalization for community-acquired pneumonia after initiation of study drug) between the two treatment groups. In the event that there were baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) were included in a multiple regression model in addition to the exposure status (Tio/Olo or ICS/LABA).||1.93|0.36|
70860773|NCT05402020|141207621|OTHER||Annualized rate ratio|0.92|||||TWO_SIDED|95.0|0.81|1.03|||||Annualized rate ratio calculated as \[annualized rate of Tio/Olo\]/\[annualized rate of ICS/LABA\].|The rate ratio of Tio+Olo - exposed group relative to LABA/ICS group, along with 95% CIs were derived using a univariate negative binomial model. In the event that there are baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) will be included in a multiple regression model in addition to the exposure status (Tio/Olo or LABA/ICS).||1.03|0.81|
70860774|NCT05402020|141207622|OTHER||Annualized rate ratio|1.01|||||TWO_SIDED|95.0|0.87|1.18|||||Annualized rate ratio calculated as \[annualized rate of Tio/Olo\]/\[annualized rate of ICS/LABA\].|The rate ratio of Tio+Olo - exposed group relative to LABA/ICS group, along with 95% CIs were derived using a univariate negative binomial model. In the event that there are baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) will be included in a multiple regression model in addition to the exposure status (Tio/Olo or LABA/ICS).||1.18|0.87|
70860775|NCT06400979|141207623|SUPERIORITY|||||||0.008|||||||ANCOVA|||||||0.008
70860776|NCT06400979|141207624|SUPERIORITY|To assess the reduction of nausea following aromatherapy, pre- and post- aromatherapy scores were compared using paired t-tests||||||0.13|||||||ANCOVA|||||||0.13
70860777|NCT06400979|141207625|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70860778|NCT06400979|141207626|OTHER|Perceived effectiveness of aromatherapy for patient satisfaction were compared with respect to post-aromatherapy scores and pre-post changes in scores using two-sample t-tests||||||0.02|TWO_SIDED|73.4|||||t-test, 2 sided|||||||0.02
70860779|NCT06400979|141207627|SUPERIORITY|||||||0.02|||||||ANCOVA|||||||0.02
70860780|NCT06400979|141207628|SUPERIORITY|||||||0.02|||||||ANCOVA|||||||0.02
70860781|NCT03739840|141207629|SUPERIORITY||Percent reduction|-5.6|||=|0.687|TWO_SIDED|95.0|-38.1|19.2||Adjusted p-values are from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp(diff)), where diff was the model estimate of the log ratio between each PSL group and placebo group.||19.2|-38.1|=0.687
70860782|NCT03739840|141207629|SUPERIORITY||Percent reduction|6.5|||=|0.687|TWO_SIDED|95.0|-22.7|28.7||Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp(diff)), where diff was the model estimate of the log ratio between each PSL group and placebo group.||28.7|-22.7|=0.687
70860783|NCT03739840|141207629|SUPERIORITY||Percent reduction|6.3|||=|0.687|TWO_SIDED|95.0|-22.9|28.6||Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp(diff)), where diff was the model estimate of the log ratio between each PSL group and placebo group.||28.6|-22.9|=0.687
70860784|NCT03739840|141207633|SUPERIORITY||Odds Ratio (OR)|1.15|||=|0.803|TWO_SIDED|95.0|0.39|3.38||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate.||3.38|0.39|=0.803
70860785|NCT03739840|141207633|SUPERIORITY||Odds Ratio (OR)|0.84|||=|0.772|TWO_SIDED|95.0|0.27|2.65||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate.||2.65|0.27|=0.772
70860786|NCT03739840|141207633|SUPERIORITY||Odds Ratio (OR)|1.01|||=|0.989|TWO_SIDED|95.0|0.33|3.08||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate.||3.08|0.33|=0.989
70860787|NCT03739840|141207634|SUPERIORITY||Odds Ratio (OR)|1.4|||=|0.425|TWO_SIDED|95.0|0.61|3.18||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate.||3.18|0.61|=0.425
70860788|NCT03739840|141207634|SUPERIORITY||Odds Ratio (OR)|1.23|||=|0.625|TWO_SIDED|95.0|0.53|2.85||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate||2.85|0.53|=0.625
70860789|NCT03739840|141207634|SUPERIORITY||Odds Ratio (OR)|1.9|||=|0.125|TWO_SIDED|95.0|0.84|4.34||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate||4.34|0.84|=0.125
70860790|NCT03739840|141207635|SUPERIORITY||Median Difference (Final Values)|3.25|||=|0.737|TWO_SIDED|95.0|-17.08|20.36||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value are based on the Wilcoxon-Mann-Whitney test. Hodges Lehmann nonparametric effect estimates and corresponding two-sided 95% asymptotic confidence intervals are provided for the effect difference between each PSL dose and placebo.||20.36|-17.08|=0.737
70947572|NCT01390441|141395533|SUPERIORITY_OR_OTHER||Percent difference|-17.5|||||TWO_SIDED|95.0|-44.4|10.9|||Miettinen-Nurminen|||The difference in percent AE incidence was determined for the treatment comparison (Part B: MK-8808 1000 mg - Part B: MabThera 1000 mg) when \>=4 participants in an arm experienced an event.||10.9|-44.4|
70947573|NCT01390441|141395533|SUPERIORITY_OR_OTHER||Percent difference|-5.6|||||TWO_SIDED|95.0|-34.9|24.6|||Miettinen-Nurminen|||The difference in percent AE incidence was determined for the treatment comparison (Part B: MK-8808 1000 mg - Part B: Rituxan® 1000 mg) when \>=4 participants in an arm experienced an event.||24.6|-34.9|
71132684|NCT03058692|141768552|OTHER|||||||0.56||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.56
71132685|NCT03058692|141768553|OTHER|||||||0.74||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.74
70947574|NCT01390441|141395533|SUPERIORITY_OR_OTHER||Percent differnce|12.0|||||TWO_SIDED|95.0|-15.6|38.9|||Miettinen-Nurminen|||The difference in percent AE incidence was determined for the treatment comparison (Part B: MabThera® 1000 mg - Part B: Rituxan® 1000 mg) when \>=4 participants in an arm experienced an event.||38.9|-15.6|
70947575|NCT01390441|141395535|NON_INFERIORITY_OR_EQUIVALENCE|PK bioequivalence was assumed if the 90% confidence interval of the geometric mean ratio for the comparison fell within the range 0.80-1.25.|Geometric mean ratio|0.98|||||TWO_SIDED|90.0|0.87|1.1|||ANOVA|||Back-transformed least squares mean and confidence interval from fixed effects model performed on natural log-transformed values containing treatment as a fixed effect and gender as a covariate.||1.1|0.87|
70947576|NCT01390441|141395539|NON_INFERIORITY_OR_EQUIVALENCE||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.9|0.5|||ANCOVA|The model included a term for treatment.||Estimated difference vs MabThera® at 6 weeks.||0.5|-0.9|
70860791|NCT03739840|141207635|SUPERIORITY||Median Difference (Net)|6.17|||=|0.458|TWO_SIDED|95.0|-10.0|21.91||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value are based on the Wilcoxon-Mann-Whitney test. Hodges Lehmann nonparametric effect estimates and corresponding two-sided 95% asymptotic confidence intervals are provided for the effect difference between each PSL dose and placebo.||21.91|-10.00|=0.458
70872117|NCT02155608|141229494|SUPERIORITY|||||||0.14||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = 2.24, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.14
70947577|NCT01390441|141395539|NON_INFERIORITY_OR_EQUIVALENCE||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.4|1.2|||ANCOVA|The model included a term for treatment.||Estimated difference vs MabThera® at 12 weeks.||1.2|-0.4|
70947578|NCT03432390|141395604|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.0001
70947579|NCT00763451|141395665|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.089|<|0.0001|TWO_SIDED|95.0|-0.583|-0.232||Stepwise testing procedure applied to control type 1 error: Lixisenatide (2-step titration) was compared with Placebo (combined), if found statistically significant, then Lixisenatide (1-step titration) arm compared with Placebo (combined).|ANCOVA|Threshold for significance at 0,05 level||"To detect a difference of 0.5% (or 0.4%) in absolute change from baseline in HbA1c at Week 24 between 1 lixisenatide arm and placebo (combined), 150 patients per group would provide a power of 91% (or 75%) assuming common standard deviation of 1.3% with 2-sided test at 5% significance level.~Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0,\>=8.0%) and screening BMI (\<30,\>=30 kg/m\^2), country as fixed effects, baseline HbA1c as covariate."||-0.232|-0.583|<0.0001
70947580|NCT00763451|141395665|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.67|-0.317||Stepwise testing procedure applied to control type 1 error: Lixisenatide (2-step titration) was compared with Placebo (combined), if found statistically significant, then Lixisenatide (1-step titration) arm compared with Placebo (combined).|ANCOVA|Threshold for significance at 0,05 level||"To detect a difference of 0.5% (or 0.4%) in absolute change from baseline in HbA1c at Week 24 between 1 lixisenatide arm and placebo (combined), 150 patients per group would provide a power of 91% (or 75%) assuming common standard deviation of 1.3% with 2-sided test at 5% significance level.~Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0,\>=8.0%) and screening BMI (\<30,\>=30 kg/m\^2), country as fixed effects, baseline HbA1c as covariate."||-0.317|-0.670|<0.0001
71132686|NCT03058692|141768553|OTHER|||||||0.73||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.73
71132687|NCT03058692|141768554|OTHER|||||||0.66||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.66
71132688|NCT03058692|141768554|OTHER|||||||0.48||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.48
70947581|NCT05594589|141395683|SUPERIORITY||Least Squares Geometric Mean(LSGM) Ratio|0.377||||0.0133|TWO_SIDED|95.0|0.175|0.81|||ANCOVA|P-value was based on analysis of covariance (ANCOVA) model with log transformation of baseline LPS and treatment arms as fixed effects.|LSGM ratio was calculated as Lemborexant 5 mg/Placebo.|||0.810|0.175|0.0133
70947582|NCT05594589|141395684|SUPERIORITY||LSGM Ratio|0.48||||0.0619|TWO_SIDED|95.0|0.222|1.038|||ANCOVA|P-value was based on ANCOVA model with log transformation of baseline LPS and treatment arms as fixed effects.|LSGM ratio was calculated as Lemborexant 10 mg/Placebo.|||1.038|0.222|0.0619
71132689|NCT03058692|141768555|OTHER|||||||0.32||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.32
71132690|NCT03058692|141768555|OTHER||||||>|0.99||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||>0.99
71132691|NCT03058692|141768556|OTHER|||||||0.0078||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.0078
70947583|NCT05594589|141395685|SUPERIORITY||Least Square Mean (LSM) Difference|7.38||||0.0689|TWO_SIDED|95.0|-0.59|15.35|||ANCOVA|P-value was based on ANCOVA model with log transformation of baseline LPS and treatment arms as fixed effects.|LSM difference was calculated as Lemborexant 5 mg - Placebo.|||15.35|-0.59|0.0689
70947584|NCT05594589|141395686|SUPERIORITY||LSM Difference|8.16||||0.0439|TWO_SIDED|95.0|0.23|16.09|||ANCOVA|P-value was based on ANCOVA model with log transformation of baseline LPS and treatment arms as fixed effects.|LSM difference was calculated as Lemborexant 10 mg - Placebo.|||16.09|0.23|0.0439
70947585|NCT02554383|141395708|SUPERIORITY|||||||0.02||||||The interactions (1) between treatment \& pathogens and (2) between treatment \& colored nasal discharge are tested simultaneously.|Mixed Models Analysis|The p value is adjusted for PRSS score at enrollment, diary day, study site, treatment, pathogens, colored nasal discharge \& interaction (2).||Null hypothesis: The effect of treatment with antibiotics does not differ in the subgroups of children defined, respectively, by the presence and by the absence of pathogens in the nasopharynx at enrollment, i.e., there is no significant interaction between treatment and pathogens in the nasopharynx.||||0.02
70947586|NCT02554383|141395708|SUPERIORITY||Difference of least-squares means|-1.95|||||TWO_SIDED|95.0|-2.4|-1.51|||||The Amoxicillin-clavulanate group represents the first number in the subtraction and the Placebo group represents the second. The estimates are adjusted for PRSS score at enrollment, diary day and study site.|Null hypothesis: There is no difference between the treatment groups in the subgroup of children defined by the presence of one or more pathogens in the nasopharynx at enrollment.||-1.51|-2.40|
70872118|NCT02155608|141229494|SUPERIORITY|||||||0.82||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = .05, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.82
70947587|NCT02554383|141395708|SUPERIORITY||Difference of least-squares means|-0.88|||||TWO_SIDED|95.0|-1.63|-0.12|||||The Amoxicillin-clavulanate group represents the first number in the subtraction and the Placebo group represents the second. The estimates are adjusted for PRSS score at enrollment, diary day and study site.|Null hypothesis: There is no difference between the treatment groups in the subgroup of children defined by the absence of one or more pathogens in the nasopharynx at enrollment.||-0.12|-1.63|
70947588|NCT02554383|141395709|SUPERIORITY|||||||0.37||||||The interactions (1) between treatment \& pathogens and (2) between treatment \& colored nasal discharge are tested simultaneously.|Mixed Models Analysis|The p value is adjusted for PRSS score at enrollment, diary day, study site, treatment, pathogens, colored nasal discharge \& interaction (1).||Null hypothesis: The effect of treatment with antibiotics does not differ in the subgroups of children defined, respectively, by the presence and by the absence of colored nasal discharge at enrollment, i.e., there is no significant interaction between treatment and colored nasal discharge.||||0.37
71132692|NCT03058692|141768556|OTHER|||||||0.94||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.94
71132693|NCT03058692|141768557|OTHER|||||||||||||||||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.|||
71132694|NCT03058692|141768557|OTHER|||||||0.5||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.5
71132695|NCT03058692|141768558|OTHER|||||||||||||||||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.|||
71132696|NCT03058692|141768558|OTHER|||||||||||||||||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.|||
71132697|NCT03058692|141768559|OTHER|||||||||||||||||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.|||
71132698|NCT03058692|141768560|OTHER|||||||||||||||||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.|||
70860792|NCT03739840|141207635|SUPERIORITY||Median Difference (Net)|9.31|||=|0.341|TWO_SIDED|95.0|-10.92|28.21||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value are based on the Wilcoxon-Mann-Whitney test. Hodges Lehmann nonparametric effect estimates and corresponding two-sided 95% asymptotic confidence intervals are provided for the effect difference between each PSL dose and placebo.||28.21|-10.92|=0.341
70860793|NCT01058265|141207637|SUPERIORITY_OR_OTHER|||||||0.487||95.0|||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in PCS between two groups.||||0.487
70860794|NCT01058265|141207638|SUPERIORITY_OR_OTHER|||||||0.817||95.0|||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in MCS between two groups.||||0.817
70860795|NCT02343081|141207645|NON_INFERIORITY_OR_EQUIVALENCE|Assuming an intrasubject CV of 15%, an enrollment of 16 subjects was selected to provide a minimum of 80% power for the 90% CI of the ratio of the mean for Cmax for Temozolomide reference and test to fall within the 80-125% confidence range.|Cmax|94.37|||<|0.05|TWO_SIDED|90.0|82.69|107.69|||ANOVA|Primary parameters were analyzed using ANOVA. A linear, mixed model for crossover designs (two-period, two-sequence, two-treatment) was used.|Cmax Test/Reference Ratio|Bioequivalence assessment was made for the 90% CI for the ratio of log transformed pharmacokinetic parameters μT / μR and with the two one-sided Schuirmann T-test procedure under the null hypothesis||107.69|82.69|<0.05
70860796|NCT02343081|141207649|NON_INFERIORITY_OR_EQUIVALENCE|Assuming an intrasubject CV of 15%, an enrollment of 16 subjects was selected to provide a minimum of 80% power for the 90% CI of the means ratio for AUC0-t for Temozolomide reference and test to fall within the 80-125% confidence range.|AUC0-t|100.99|||<|0.05|TWO_SIDED|90.0|97.81|104.28|||ANOVA||AUC0-t Test/Reference Ratio|||104.28|97.81|<0.05
70860797|NCT02343081|141207650|NON_INFERIORITY_OR_EQUIVALENCE|Assuming an intrasubject CV of 15%, an enrollment of 16 subjects was selected to provide a minimum of 80% power for the 90% CI of the means ratio for AUC0-inf for Temozolomide reference and test to fall within the 80-125% confidence range.|AUC0-inf|101.53|||<|0.05|TWO_SIDED|90.0|98.6|104.54|||ANOVA||AUC0-inf Test/Reference Ratio|||104.54|98.60|<0.05
70860798|NCT05014490|141207694|EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. The level of significance was set to the standard value of 5% (0.05) for all statistical tests.|Ratio of the T/R geometric mean x 100|102.15|||||TWO_SIDED|90.0|94.54|110.37|||||The ratio of geometric LSmeans with corresponding 90% CI calculated from the exponential of the difference between the test and reference products for the ln-transformed parameters should be within the acceptance interval of 80.00 - 125.00%.|||110.37|94.54|
70860799|NCT05014490|141207695|EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. The level of significance was set to the standard value of 5% (0.05) for all statistical tests.|Ratio of the T/R geometric mean x 100|99.23|||||TWO_SIDED|90.0|96.97|101.54|||||The ratio of geometric LSmeans with corresponding 90% CI calculated from the exponential of the difference between the test and reference products for the ln-transformed parameters should be within the acceptance interval of 80.00 - 125.00%.|||101.54|96.97|
70860800|NCT03880461|141207699|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
70860801|NCT03880461|141207700|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
70860802|NCT03880461|141207701|SUPERIORITY|||||||0.108|||||||ANOVA|||||||0.108
70860803|NCT04025710|141207726|OTHER|single arm design|SADE-free rate|0.97||||0.05|TWO_SIDED|95.0|0.9|1.0|||t-test, 2 sided|||The primary hypothesis evaluates the SADE free rate (pSADE\_free) at 3 months. Ho: SADE-free rate through 3 months post-implant ≤ 90.0% Ha: SADE-free rate through 3 months post-implant \> 90.0%||1|0.9|0.05
70860804|NCT02431247|141207731|NON_INFERIORITY|One-sided p-value for non-inferiority of Test versus Control arm. The non-|Difference in percentage|2.7|||<|0.001|TWO_SIDED|95.0|-1.6|7.1||inferiority margin is 10%.|Mantel Haenszel|||||7.1|-1.6|< 0.001
70860805|NCT02431247|141207734|OTHER||Least square mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.063|=|0.437|TWO_SIDED|95.0|-0.171|0.074|||ANCOVA|||||0.074|-0.171|= 0.437
70860806|NCT02431247|141207735|OTHER||LS mean difference|18.48|STANDARD_ERROR_OF_MEAN|14.808|=|0.213|TWO_SIDED|95.0|-10.595|47.55|||ANCOVA|||||47.550|-10.595|= 0.213
70860807|NCT02431247|141207736|OTHER||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.008|<|0.001|TWO_SIDED|95.0|-0.05|-0.02|||ANCOVA|||||-0.02|-0.05|< 0.001
70860808|NCT02431247|141207737|OTHER||LS mean difference|3.12|STANDARD_ERROR_OF_MEAN|0.786|<|0.001|TWO_SIDED|95.0|1.57|4.66|||ANCOVA|||||4.66|1.57|< 0.001
70860809|NCT02431247|141207738|OTHER||LS mean difference|6.04|STANDARD_ERROR_OF_MEAN|1.126|<|0.001|TWO_SIDED|95.0|3.83|8.25|||ANCOVA|||||8.25|3.83|< 0.001
70860810|NCT02431247|141207739|OTHER||LS mean difference|2.4|STANDARD_ERROR_OF_MEAN|0.747|=|0.001|TWO_SIDED|95.0|0.93|3.87|||ANCOVA|||||3.87|0.93|= 0.001
70860811|NCT02431247|141207741|OTHER||||||=|0.033|||||||Wilcoxon rank sum test|||||||= 0.033
70860812|NCT02431247|141207742|OTHER||||||=|0.033|||||||Wilcoxon rank sum test|||||||= 0.033
70860813|NCT02431247|141207743|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||< 0.001
70860814|NCT02431247|141207744|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||< 0.001
70860815|NCT02431247|141207745|OTHER||||||=|0.147|||||||Wilcoxon rank sum test|||||||= 0.147
70860816|NCT02431247|141207750|OTHER||LS mean difference|1.95|STANDARD_ERROR_OF_MEAN|0.368|<|0.001|TWO_SIDED|95.0|1.227|2.678|||ANCOVA|||Hip region BMD (Week 24)||2.678|1.227|< 0.001
70860817|NCT02431247|141207750|OTHER||LS mean difference|2.86|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|1.934|3.791|||ANCOVA|||Hip region BMD (Week 48)||3.791|1.934|< 0.001
70860818|NCT02431247|141207750|OTHER||LS mean difference|2.09|STANDARD_ERROR_OF_MEAN|0.421|<|0.001|TWO_SIDED|95.0|1.259|2.919|||ANCOVA|||Spine region BMD (Week 24)||2.919|1.259|< 0.001
70860819|NCT02431247|141207750|OTHER||LS mean difference|1.7|STANDARD_ERROR_OF_MEAN|0.588|=|0.004|TWO_SIDED|95.0|0.539|2.858|||ANCOVA|||Spine region BMD (Week 48)||2.858|0.539|= 0.004
70860820|NCT01369485|141207790|SUPERIORITY_OR_OTHER|||||||0.3636|||||||Chi-squared|||The sample size calculation was determined using the 2-sided Chi-square test with a significance level of 5% and 80% power based upon the following assumptions: (1) proportion of responders at end of 12 weeks of treatment would be 50% in the active (test) group and 25% in the inactive (control) group; (2) a responder was defined as a subject who experienced decrease of ≥50% in mean urgency urinary incontinence episodes (leaks) between baseline and Week 12 of the study; (3) 20 % dropout rate.||||0.3636
70860821|NCT01369485|141207790|SUPERIORITY_OR_OTHER|||||||0.4849|||||||Chi-squared|||||||0.4849
70860822|NCT01369485|141207791|SUPERIORITY_OR_OTHER|||||||0.2893|||||||Wilcoxon (Mann-Whitney)|||||||0.2893
70860823|NCT01369485|141207791|SUPERIORITY_OR_OTHER|||||||0.3223|||||||Wilcoxon (Mann-Whitney)|||||||0.3223
70860824|NCT01369485|141207792|SUPERIORITY_OR_OTHER|||||||0.3387|||||||Wilcoxon (Mann-Whitney)|||||||0.3387
70860825|NCT01369485|141207793|SUPERIORITY_OR_OTHER|||||||0.6557|||||||Wilcoxon (Mann-Whitney)|||||||0.6557
70860826|NCT01369485|141207794|SUPERIORITY_OR_OTHER|||||||0.4354|||||||Wilcoxon (Mann-Whitney)|||||||0.4354
70860827|NCT01369485|141207795|SUPERIORITY_OR_OTHER|||||||0.9918|||||||Wilcoxon (Mann-Whitney)|||||||0.9918
70860828|NCT01369485|141207795|SUPERIORITY_OR_OTHER|||||||0.377|||||||Wilcoxon (Mann-Whitney)|||||||0.3770
70860829|NCT01369485|141207796|SUPERIORITY_OR_OTHER|||||||0.4147|||||||Fisher Exact|||||||0.4147
70860830|NCT01369485|141207796|SUPERIORITY_OR_OTHER|||||||0.0877|||||||Fisher Exact|||||||0.0877
70947589|NCT02554383|141395709|SUPERIORITY||Difference of least-squares means|-1.62|||||TWO_SIDED|95.0|-2.09|-1.16|||||The Amoxicillin-clavulanate group represents the first number in the subtraction and the Placebo group represents the second. The estimates are adjusted for PRSS score at enrollment, diary day and study site.|Null hypothesis: There is no difference between the treatment groups in the subgroup of children defined by the presence of colored nasal discharge at enrollment.||-1.16|-2.09|
70860831|NCT01369485|141207797|SUPERIORITY_OR_OTHER|||||||0.2032|||||||Fisher Exact|||||||0.2032
70860832|NCT01369485|141207798|SUPERIORITY_OR_OTHER|||||||0.4151||||||Calculated for only those patients who had prior OAB treatment only.|Wilcoxon (Mann-Whitney)|||||||0.4151
70860833|NCT01369485|141207799|SUPERIORITY_OR_OTHER|||||||0.9814|||||||Fisher Exact|||"Endpoint defined as percentage of patients that much improved or very much improved following treatment."||||0.9814
70860834|NCT01369485|141207799|SUPERIORITY_OR_OTHER|||||||0.7305|||||||Fisher Exact|||||||0.7305
70860835|NCT01369485|141207800|SUPERIORITY_OR_OTHER|||||||0.2191|||||||Wilcoxon (Mann-Whitney)|||||||0.2191
70860836|NCT01369485|141207800|SUPERIORITY_OR_OTHER|||||||0.5357|||||||Wilcoxon (Mann-Whitney)|||||||0.5357
70860837|NCT00586196|141207811|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.4|2.3|||GEE|||||2.3|0.4|
70860838|NCT00586196|141207812|SUPERIORITY_OR_OTHER||Effect Size|-0.2|||||TWO_SIDED|95.0|-1.5|1.2|||GEE|||||1.2|-1.5|
70860839|NCT01484054|141207818|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -5 points(CLUE) was used.|Least square mean difference|1.0|STANDARD_ERROR_OF_MEAN|2.117|||TWO_SIDED|95.0|-3.2|5.2|||Mixed Models Analysis|||The alternative hypothesis is that etafilcon A with PVP lenses is non-inferior to etafilcon A control lenses for the Overall Quality of Lens Vision at 7-9 days of follow-up.||5.20|-3.20|
70860840|NCT01484054|141207819|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -5 points(CLUE) was used.|Least square mean difference|4.7|STANDARD_ERROR_OF_MEAN|2.772|||TWO_SIDED|95.0|-0.79|10.19|||Mixed Models Analysis|||The alternative hypothesis is that etafilcon A with PVP lenses is non-inferior to etafilcon A control lenses for the Overall Lens Comfort at 7-9 days of follow-up.||10.19|-0.79|
70860841|NCT01484054|141207820|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -5 points(CLUE) was used.|Least square mean difference|9.44|STANDARD_ERROR_OF_MEAN|1.829|||TWO_SIDED|95.0|5.81|13.07|||Mixed Models Analysis|||Ho: The test lens is non-inferior to the active comparator lens for Handling at 7-9 days follow-up.||13.07|5.81|
70860842|NCT01610271|141207821|SUPERIORITY|ABS was expected to be superior to Control.|Odds Ratio (OR)|0.11|STANDARD_ERROR_OF_MEAN|0.16||0.067|TWO_SIDED|95.0|0.01|2.05||a priori threshold was 0.05|Regression, Logistic|penalized maximum likelihood (Firth) logistic regression, because infection rate was very low (\<3%), as expected|The dispersion is the SE of the OR. ABS was the numerator group, Control was the denominator.|A sample size of 150 per group provided a power of 80% to detect a statistically significant (α≤0.05) 3% difference in SSI rate based on a historical infection rate of 6% in the facility where operations were performed.||2.05|0.01|0.067
70860843|NCT00364130|141207825|SUPERIORITY_OR_OTHER|||||||0.38||||||The outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.38
70860844|NCT00364130|141207826|SUPERIORITY_OR_OTHER|||||||0.8||||||The outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.80
70860845|NCT00364130|141207827|SUPERIORITY_OR_OTHER|||||||0.02||||||The outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.02
70860846|NCT00364130|141207828|SUPERIORITY_OR_OTHER|||||||0.27||||||The outcome was not adjusted for multiple comparisons|Regression, Linear|||||||0.27
70860847|NCT00364130|141207829|SUPERIORITY_OR_OTHER|||||||0.84||||||The outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.84
70860848|NCT00364130|141207830|SUPERIORITY_OR_OTHER|||||||0.66||||||The outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.66
70860849|NCT00364130|141207831|SUPERIORITY_OR_OTHER|||||||0.7||||||The outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.70
70860850|NCT00364130|141207832|SUPERIORITY_OR_OTHER|||||||0.98||||||Outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.98
70860851|NCT00410202|141207833|SUPERIORITY_OR_OTHER||Difference Estimate|8.9||||0.1336|TWO_SIDED|95.0|-2.0|19.9|||Hochberg procedure|||||19.9|-2.0|0.1336
70860852|NCT00410202|141207833|SUPERIORITY_OR_OTHER||Difference Estimate|5.7||||0.2619|TWO_SIDED|95.0|-4.2|15.5|||Hochberg procedure|||||15.5|-4.2|0.2619
70860853|NCT00410202|141207834|SUPERIORITY_OR_OTHER||Difference estimate|15.0||||0.0095|TWO_SIDED|95.0|3.7|26.4|||Hochberg procedure|||||26.4|3.7|0.0095
70860854|NCT00410202|141207835|SUPERIORITY_OR_OTHER||Difference Estimate|11.8|||||TWO_SIDED|95.0|2.5|21.1||||||||21.1|2.5|
70860855|NCT00410202|141207835|SUPERIORITY_OR_OTHER||Difference Estimate|8.6|||||TWO_SIDED|95.0|-1.1|18.2||||||||18.2|-1.1|
70860856|NCT00410202|141207836|SUPERIORITY_OR_OTHER||Difference estimate|12.9|||||TWO_SIDED|95.0|1.8|23.9||||||||23.9|1.8|
70860857|NCT00410202|141207837|SUPERIORITY_OR_OTHER||Difference Estimate|8.9|||||TWO_SIDED|95.0|0.3|17.4||||||||17.4|0.3|
70860858|NCT00410202|141207837|SUPERIORITY_OR_OTHER||Difference Estimate|8.6|||||TWO_SIDED|95.0|-0.1|17.3||||||||17.3|-0.1|
70860859|NCT00410202|141207838|SUPERIORITY_OR_OTHER||Difference estimate|12.9|||||TWO_SIDED|95.0|2.4|23.4||||||||23.4|2.4|
70860860|NCT00410202|141207841|SUPERIORITY_OR_OTHER||Difference Estimate|-1.26|||||TWO_SIDED|95.0|-1.534|-0.994|||Regression, Linear|||||-0.994|-1.534|
70860861|NCT00410202|141207841|SUPERIORITY_OR_OTHER||Difference Estimate|-0.55|||||TWO_SIDED|95.0|-0.824|-0.281|||Regression, Linear|||||-0.281|-0.824|
70860862|NCT00410202|141207843|SUPERIORITY_OR_OTHER||Difference Estimate|-2.4|||||TWO_SIDED|95.0|-15.5|10.7||||||||10.7|-15.5|
70860863|NCT00410202|141207843|SUPERIORITY_OR_OTHER||Difference Estimate|-1.2|||||TWO_SIDED|95.0|-15.0|12.6||||||||12.6|-15.0|
70860864|NCT00410202|141207844|SUPERIORITY_OR_OTHER||Difference Estimate|-2.8|||||TWO_SIDED|95.0|-16.2|10.6||||||||10.6|-16.2|
70860865|NCT00410202|141207845|SUPERIORITY_OR_OTHER||Difference Estimate|0.8|||||TWO_SIDED|95.0|-5.2|6.7||||||||6.7|-5.2|
70860866|NCT00410202|141207845|SUPERIORITY_OR_OTHER||Difference Estimate|1.3|||||TWO_SIDED|95.0|-4.6|7.2||||||||7.2|-4.6|
70860867|NCT00410202|141207846|SUPERIORITY_OR_OTHER||Difference Estimate|-1.5|||||TWO_SIDED|95.0|-9.5|6.4||||||||6.4|-9.5|
70947590|NCT02554383|141395709|SUPERIORITY||Difference of least-squares means|-1.7|||||TWO_SIDED|95.0|-2.38|-1.03|||||The Amoxicillin-clavulanate group represents the first number in the subtraction and the Placebo group represents the second. The estimates are adjusted for PRSS score at enrollment, diary day and study site.|Null hypothesis: There is no difference between the treatment groups in the subgroup of children defined by the absence of colored nasal discharge at enrollment.||-1.03|-2.38|
70947591|NCT02554383|141395710|SUPERIORITY|||||||0.003|||||||Log-binomial regression|The p-value is adjusted for study site and and presence of colored nasal discharge.||Null hypothesis: There is no difference between the treatment groups in the proportion of children experiencing treatment failure.||||0.003
70947592|NCT02554383|141395711|SUPERIORITY|||||||0.007|||||||Fisher Exact|||Null hypothesis: There is no difference between the treatment groups in the proportion of children developing AOM over the first 10 days of follow-up.||||.007
70947593|NCT02554383|141395712|SUPERIORITY||||||<|0.001|||||||Log-binomial regression|The p-value is adjusted for study site and and presence of colored nasal discharge.||Null hypothesis: There is no difference between the treatment groups in the proportion of children receiving a systemic antibiotic over the first 10 days of follow-up.||||<0.001
70860868|NCT00410202|141207847|SUPERIORITY_OR_OTHER||Difference Estimate|2.2|||||TWO_SIDED|95.0|-2.4|6.8||||||||6.8|-2.4|
70860869|NCT00410202|141207847|SUPERIORITY_OR_OTHER||Difference Estimate|1.4|||||TWO_SIDED|95.0|-3.5|6.2||||||||6.2|-3.5|
70860870|NCT00410202|141207848|SUPERIORITY_OR_OTHER||Difference Estimate|2.1|||||TWO_SIDED|95.0|-3.6|7.8||||||||7.8|-3.6|
70860871|NCT00410202|141207849|SUPERIORITY_OR_OTHER||Difference Estimate|0.7|||||TWO_SIDED|95.0|-0.7|2.1||||||||2.1|-0.7|
70860872|NCT00410202|141207849|SUPERIORITY_OR_OTHER||Difference Estimate|0.0|||||TWO_SIDED|95.0|-2.0|2.0||||||||2.0|-2.0|
70860873|NCT00410202|141207851|SUPERIORITY_OR_OTHER||Difference Estimate|0.7|||||TWO_SIDED|95.0|-0.7|2.1||||||||2.1|-0.7|
70860874|NCT00410202|141207851|SUPERIORITY_OR_OTHER||Difference Estimate|0.7|||||TWO_SIDED|95.0|-0.7|2.1||||||||2.1|-0.7|
70860875|NCT00144027|141207868|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.57||||0.03|TWO_SIDED|95.0|1.21|47.53|||Regression, Logistic|logistic regression predicting 6-month adherence, controling for baseline depression, extrapyramidal side effects, and baseline adherence.||||47.53|1.21|0.03
70860876|NCT03052764|141207929|SUPERIORITY||Least Squares Mean Difference|-2.57|STANDARD_ERROR_OF_MEAN|0.561|<|0.0001|TWO_SIDED|95.0|-3.68|-1.46|||ANCOVA|||||-1.46|-3.68|<.0001
70860877|NCT03052764|141207930|SUPERIORITY||Odds Ratio (OR)|6.15|||||TWO_SIDED|95.0|0.75|50.37|||||Values obtained were from a Cochran Mantel-Haenszel test adjusting for the number of UUI episodes reported at Baseline (\<= 9 versus \> 9 daily episodes)at each scheduled visit.|||50.37|0.75|
70860878|NCT03052764|141207931|SUPERIORITY||Least Squares Mean Difference|-2.24|STANDARD_ERROR_OF_MEAN|0.534|<|0.0001|TWO_SIDED|95.0|-3.3|-1.18|||ANCOVA|||||-1.18|-3.30|<.0001
70947594|NCT02554383|141395713|SUPERIORITY|||||||0.004|||||||Log-binomial regression|The p-value is adjusted for study site and presence of colored nasal discharge.||Null hypothesis: There is no difference between the treatment groups in the proportion of children for whom diarrhea or generalized rash was reported.||||0.004
70947595|NCT02554383|141395714|SUPERIORITY|||||||0.75|||||||Log-binomial regression|The p-value is adjusted for presence of colored nasal discharge.||Null hypothesis: There is no difference between the treatment groups in the proportion of children compliant with study product.||||0.75
70860879|NCT03052764|141207932|SUPERIORITY||Least Squares Mean Difference|-2.56|STANDARD_ERROR_OF_MEAN|0.59|<|0.0001|TWO_SIDED|95.0|-3.73|-1.39|||ANCOVA|||||-1.39|-3.73|<.0001
70860880|NCT03052764|141207933|SUPERIORITY||Least Squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.192||0.0004|TWO_SIDED|95.0|-1.09|-0.32|||ANCOVA|||||-0.32|-1.09|0.0004
70860881|NCT03052764|141207934|SUPERIORITY||Odds Ratio (OR)|13.03|||||TWO_SIDED|95.0|3.23|52.57|||||Values were obtained from a Cochran Mantel-Haenszel test adjusting for the number of UUI episodes reported at Baseline (\<= 9 versus \> 9 daily episodes) at each scheduled visit.|||52.57|3.23|
70860882|NCT03332771|141207968|NON_INFERIORITY|The non-inferiority hypothesis was declared significant if the upper bound of the 2-sided 95% confidence interval (CI) for the adjusted mean difference is \<0.3.|Difference in Least Squares (LS) Mean|0.12|STANDARD_ERROR_OF_MEAN|0.122||0.3306|TWO_SIDED|95.0|-0.12|0.357|||ANCOVA|||The change from baseline to Week 52 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||0.357|-0.120|0.3306
70860883|NCT03332771|141207968|NON_INFERIORITY|The non-inferiority hypothesis was declared significant if the upper bound of the 2-sided 95% CI for the adjusted mean difference is \<0.3.|Difference in LS Mean|-0.04|STANDARD_ERROR_OF_MEAN|0.114||0.7112|TWO_SIDED|95.0|-0.265|0.181|||ANCOVA|||The change from baseline to Week 52 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||0.181|-0.265|0.7112
70860884|NCT03332771|141207969|SUPERIORITY||Difference in LS Mean|-0.21|STANDARD_ERROR_OF_MEAN|0.119||0.0827|TWO_SIDED|95.0|-0.44|0.027|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||0.027|-0.440|0.0827
70947596|NCT02554383|141395715|SUPERIORITY|||||||0.63|||||||Log-binomial regression|The p-value is adjusted for study site and presence of colored nasal discharge.||Null hypothesis: There is no difference between the treatment groups in the proportion of children with a nonsusceptible pathogen at the follow-up visit.||||0.63
70860885|NCT03332771|141207969|SUPERIORITY||Difference in LS Mean|-0.37|STANDARD_ERROR_OF_MEAN|0.103||0.0003|TWO_SIDED|95.0|-0.571|-0.167|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||-0.167|-0.571|0.0003
70860886|NCT03332771|141207970|SUPERIORITY||Difference in LS Mean|-1.49|STANDARD_ERROR_OF_MEAN|0.349|<|0.0001|TWO_SIDED|95.0|-2.173|-0.803|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups (placebo, sotagliflozin 200 mg, sotagliflozin 400 mg, glimepiride), randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, randomization strata of SBP (\<130,≥ 130 mmHg) at screening, and country as fixed effects, and baseline body weight as a covariate.||-0.803|-2.173|<0.0001
70860887|NCT03332771|141207970|SUPERIORITY||Difference in LS Mean|-3.58|STANDARD_ERROR_OF_MEAN|0.544|<|0.0001|TWO_SIDED|95.0|-4.651|-2.517|||ANCOVA|||The change from baseline to Week 52 is analyzed using analysis of ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects and baseline body weight as a covariate.||-2.517|-4.651|< 0.0001
70860888|NCT03332771|141207971|SUPERIORITY||Difference in LS Mean|-4.18|STANDARD_ERROR_OF_MEAN|1.288||0.0012|TWO_SIDED|95.0|-6.701|-1.65|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, and country as fixed effects, and baseline SBP as a covariate.||-1.650|-6.701|0.0012
70860889|NCT03332771|141207971|SUPERIORITY||Difference in LS Mean|-2.7|STANDARD_ERROR_OF_MEAN|0.0973||0.0973|TWO_SIDED|95.0|-5.89|0.491|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, and country as fixed effects, and baseline SBP as a covariate.||0.491|-5.890|0.0973
70860890|NCT03332771|141207972|SUPERIORITY||Difference in LS Mean|-4.02|STANDARD_ERROR_OF_MEAN|0.87|<|0.0001|TWO_SIDED|95.0|-5.73|-2.319|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, and country as fixed effects, and baseline SBP as a covariate.||-2.319|-5.730|<0.0001
70860891|NCT03332771|141207973|SUPERIORITY||Percentage difference|-15.4|||<|0.0001|TWO_SIDED|95.0|-19.67|-11.12|||Cochran-Mantel-Haenszel|||Weighted average of percentage difference between treatment groups from each stratum \[randomization strata of HbA1c \[≤8.5%, \>8.5%\] at screening, randomization strata of mean SBP \[\<130, ≥130 mmHg\] at screening using Cochran-Mantel-Haenszel weights.||-11.12|-19.67|<0.0001
70860892|NCT01557894|141208036|SUPERIORITY_OR_OTHER||||||<|0.01|ONE_SIDED|95.0||||The a priori threshold for statistical significance was set at .05|ANCOVA|Changes in primary outcome measures were evaluated using univariate ANCOVA, with pre-intervention scores as covariates, and group as a fixed factor||||||<0.01
70860893|NCT01557894|141208037|SUPERIORITY_OR_OTHER||||||<|0.01|ONE_SIDED|95.0||||The a priori threshold for statistical significance was set at .05|ANCOVA|Changes in primary outcome measures were evaluated using univariate ANCOVA, with pre-intervention scores as covariates, and group as a fixed factor||||||<0.01
70860894|NCT01557894|141208038|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|Changes in primary outcome measures were evaluated using univariate ANCOVA, with pre-intervention scores as covariates, and group as a fixed factor.||||||<0.01
70860895|NCT01557894|141208039|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|||||||<0.01
70860896|NCT01557894|141208040|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|||||||<0.01
70947597|NCT01185171|141395751|NON_INFERIORITY|The power of the study was conducted as a two-stage, non-inferiority phase II trial with a total sample size of 59 patients to detect a 15% lower rate than 80% achieved with TFHX, with alpha = 0.05 and beta = 0.20. In the first stage, 25 patients were recruited, with a plan to terminate if 16 or less complete responses (CR) were observed. Otherwise, additional 34 patients would be recruited and the treatment would be deemed not inferior to historical if more than 45 CRs were observed.|proportion|0.88|||<|0.01|TWO_SIDED|95.0|0.77|0.95||Ho: CR rate = 0.65 vs Ha: CR rate \> 0.65|Binomial test for a proportion|||||0.95|0.77|< 0.01
70860897|NCT04123665|141208041|SUPERIORITY||Mean Difference (Net)|-0.07|||<|0.0001|TWO_SIDED|95.0|-0.11|-0.04|||ANCOVA|Analysis of Covariance (ANCOVA) with factors for treatment group and gender, and the baseline whole mouth mean BI and whole mouth MGI as covariates.|Difference is first named treatment (experimental) minus second named treatment (control).|||-0.04|-0.11|<0.0001
70860898|NCT02237911|141208050|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.071|TWO_SIDED|98.3|-4.9|0.7|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.7|-4.9|0.071
70947598|NCT00727506|141395756|SUPERIORITY_OR_OTHER|||||||0.148||95.0||||P-value is from an approximate normal test for the 6 month time point.|z-test|||||||0.148
70860899|NCT02237911|141208050|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.074|TWO_SIDED|98.3|-5.0|0.7|||Mixed Models Analysis|||Contrasts from a linear mixed models analysis at 6 months adjusted by baseline age, gender, BMI, WOMAC-PF, knee flexion.||0.7|-5.0|0.074
70860900|NCT02237911|141208050|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.93|TWO_SIDED|98.3|-2.7|2.9|||Mixed Models Analysis|||Contrasts from a linear mixed models analysis at 3 months adjusted by baseline age, gender, BMI, WOMAC-PF, knee flexion.||2.9|-2.7|0.930
70860901|NCT02237911|141208050|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.491|TWO_SIDED|98.3|-3.7|2.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||2.0|-3.7|0.491
70860902|NCT02237911|141208050|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.021|TWO_SIDED|98.3|-4.5|0.1|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.1|-4.5|0.021
70860903|NCT02237911|141208050|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.179|TWO_SIDED|98.3|-3.6|1.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||1.0|-3.6|0.179
70860904|NCT02237911|141208051|SUPERIORITY||Mean Difference (Final Values)|0.3|||<|0.0001|TWO_SIDED|98.3|0.1|0.4|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.4|0.1|<0.0001
70860905|NCT02237911|141208051|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.012|TWO_SIDED|98.3|0.01|0.4|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.4|0.01|0.012
70860906|NCT02237911|141208051|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.005|TWO_SIDED|98.3|0.02|0.3|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.3|0.02|0.005
70860907|NCT02237911|141208051|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.052|TWO_SIDED|98.3|-0.003|0.3|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.3|-0.003|0.052
70860908|NCT02237911|141208051|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.015|TWO_SIDED|98.3|0.02|0.3|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.3|0.02|0.015
70947599|NCT00727506|141395756|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value is an approximate normal test for the six month time point.|z-test|||||||0.008
70947600|NCT00727506|141395758|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0000
70947601|NCT00727506|141395758|SUPERIORITY_OR_OTHER|||||||0.1954||95.0|||||Fisher Exact|||||||0.1954
71132699|NCT03058692|141768560|OTHER|||||||0.5||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.5
71132700|NCT03058692|141768561|OTHER||||||>|0.99||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||>0.99
71132701|NCT03058692|141768561|OTHER|||||||0.74||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.74
71132702|NCT03058692|141768562|OTHER|||||||0.5||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.50
71132703|NCT03058692|141768562|OTHER|||||||0.9||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.90
71132704|NCT03058692|141768563|OTHER|||||||0.87||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.87
71132705|NCT03058692|141768563|OTHER|||||||0.57||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.57
71132706|NCT03058692|141768564|OTHER|||||||0.82||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.82
71132707|NCT03058692|141768564|OTHER|||||||0.076||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.076
70860909|NCT02237911|141208051|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.489|TWO_SIDED|98.3|-0.003|0.3|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.3|-0.003|0.489
70860910|NCT02237911|141208052|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.943|TWO_SIDED|95.0|-106.0|114.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||114|-106|0.943
70860911|NCT02237911|141208052|SUPERIORITY||Mean Difference (Final Values)|15.0||||0.814|TWO_SIDED|95.0|-112.0|142.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||142|-112|0.814
70860912|NCT02237911|141208052|SUPERIORITY||Mean Difference (Final Values)|-15.0||||0.787|TWO_SIDED|95.0|-125.0|95.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||95|-125|0.787
70947602|NCT00727506|141395759|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.78||||0.032|TWO_SIDED|95.0|1.088|2.912|||Log Rank|||Hazard ratio was calculated from Cox proportional hazard model stratified by age class (\<=50 vs. \>50 years old) and baseline Karnofsky Performance Scale (KPS) score (70, 80 vs. 90, 100). P-value was two-sided from log-rank test stratified by the same variables.||2.912|1.088|0.0320
70947603|NCT00727506|141395759|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.392||||0.2044|TWO_SIDED|95.0|0.841|2.301|||Log Rank|||Hazard ratio was calculated from Cox proportional hazard model stratified by age class (\<=50 vs. \>50 years old) and baseline KPS score (70, 80 vs. 90, 100). P-value was two-sided from log-rank test stratified by the same variables.||2.301|0.841|0.2044
70947604|NCT01255761|141395862|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 2-sided 95 % CI was greater than -10 %, the null hypothesis was rejected and RAPID3 was deemed comparable to CDAI in assessing response to Certolizumab Pegol therapy at 12 weeks.|Difference in proportion|-0.119|||||TWO_SIDED|95.0|-0.184|-0.053||Study was intended to show the comparability of RAPID3 with CDAI. Assessment of whether the study objective was met was based on CIs rather than p-values. Both variables need to be significant to claim comparability between the two assessment tools.|ANCOVA|Difference in proportions from ANCOVA with tool as factor \& Baseline DAS28(ESR), gender, age, prior anti-TNF use \& disease duration as covariates.||"The null hypothesis was: (Proportion of Rapid 3 responders)-(Proportion of CDAI responders) ≤ delta with a delta of -10 %.~A 2-sided 95 % Confidence Interval (CI) for the difference in proportion of responders was computed."||-0.053|-0.184|
70947605|NCT01255761|141395863|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 2-sided 95 % CI was greater than -15 %, the null hypothesis was rejected and RAPID3 was deemed comparable to CDAI in assessing percent of Week 12 responders achieving LDA at Week 52.|Difference in proportion|-0.013|||||TWO_SIDED|95.0|-0.093|0.066||Study was intended to show the comparability of RAPID3 with CDAI. Assessment of whether the study objective was met was based on CIs rather than p-values. Both variables need to be significant to claim comparability between the two assessment tools.|ANCOVA|Difference in proportions from ANCOVA with tool as factor \& Baseline DAS28(ESR), gender, age, prior anti-TNF use \& disease duration as covariates.||"The null hypothesis was: (Proportion of Rapid 3 responders)-(Proportion of CDAI responders) ≤ delta with a delta of -15 %.~A 2-sided 95 % Confidence Interval (CI) for the difference in proportion of responders was computed."||0.066|-0.093|
70947606|NCT02647645|141395947|SUPERIORITY|Power calculation was based on similar studies of cognitive training with transcranial direct current stimulation (tDCS).||||||0.02||||||Probability associated with the test of the interaction between participants' performance and session number in repeated measures analysis of covariance. In light of small sample size, estimated effect size was also calculated (d = 1.78).|ANCOVA|Test was adjusted for age, gender, race, education, CD4 count, and log viral load.||Analysis results are overall estimated marginal means from repeated measures analysis of covariance with treatment group as a fixed factor and age, gender, race, education, cluster of differentiation (CD4) cell count, and log viral load as covariates.||||0.02
71132708|NCT03058692|141768565|OTHER||||||>|0.99||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||>0.99
70860913|NCT02237911|141208052|SUPERIORITY||Mean Difference (Final Values)|-36.0||||0.581|TWO_SIDED|95.0|-164.0|92.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||92|-164|0.581
70860914|NCT02237911|141208052|SUPERIORITY||Mean Difference (Final Values)|19.0||||0.676|TWO_SIDED|95.0|-71.0|109.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||109|-71|0.676
70860915|NCT02237911|141208052|SUPERIORITY||Mean Difference (Final Values)|51.0||||0.33|TWO_SIDED|95.0|-52.0|154.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||154|-52|0.330
70860916|NCT00958789|141208068|NON_INFERIORITY|"For the primary efficacy hypothesis, H0, the total KSS change from preoperative to 2 years postoperative will be less than or equal to delta. The alternative hypothesis, Ha, will be that the total KSS change from preop to 2 years postoperative is greater than delta. When delta=63, the hypothesis will test for non-inferiority. When delta=70, the hypothesis will test for superiority.~H0: mean 2-year - mean preop less than or equal to delta. Ha: mean 2-year - mean preop greater than delta."|Mean Difference (Final Values)|70.7|||||ONE_SIDED|95.0|64.43||||||||||64.43|
70860917|NCT01885871|141208092|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
70860918|NCT00090051|141208101|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.0218|TWO_SIDED|95.0|0.6|0.96|||Log Rank|non-stratified|The hazard ratio was estimated using Cox regression. The hazard ratio is relative to the fludarabine+cyclophosphamide(FC) group.|The null hypothesis was that there was no difference between the 2 treatment groups. The alternative hypothesis was that progression-free survival was longer in the fludarabine+cyclophosphamide+rituximab (FCR) group.||0.96|0.60|0.0218
70860919|NCT00090051|141208102|SUPERIORITY_OR_OTHER|||||||0.2874||95.0|||||Log Rank|non-stratified||||||0.2874
70860920|NCT00090051|141208104|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Log Rank|non-stratified||||||0.0002
70860921|NCT00090051|141208107|SUPERIORITY_OR_OTHER|||||||0.8842||95.0|||||Log Rank|non-stratified||||||0.8842
70860922|NCT00090051|141208109|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66|||<|0.0001|TWO_SIDED|95.0|0.54|0.8|||Log Rank|||||0.80|0.54|<.0001
70860923|NCT00090051|141208110|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.5976|TWO_SIDED|95.0|0.74|1.19|||Log Rank|||||1.19|0.74|0.5976
70860924|NCT00090051|141208111|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.54|0.79|||Log Rank|||||0.79|0.54|<.0001
70860925|NCT00090051|141208112|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.15||||0.0005|TWO_SIDED|95.0|1.39|3.35|||Chi-squared|||||3.35|1.39|0.0005
70860926|NCT00090051|141208113|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.3085|TWO_SIDED|95.0|0.46|1.28|||Log Rank|||||1.28|0.46|0.3085
70860927|NCT00090051|141208114|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.0007|TWO_SIDED|95.0|0.51|0.84|||Log Rank|||||0.84|0.51|0.0007
70860928|NCT00090051|141208115|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0002|TWO_SIDED|95.0|0.55|0.84|||Log Rank|||||0.84|0.55|0.0002
70860929|NCT01896479|141208116|NON_INFERIORITY|The non-inferiority margin used was 1.58.|Cox Proportional Hazard|1.24||||0.1916|TWO_SIDED|95.0|0.9|1.7||Stratification factors comprised RET M918T mutational status (positive, negative, and unknown).|Log Rank|||||1.70|0.90|0.1916
70860930|NCT01896479|141208117|OTHER|Descriptive statistical analysis.|Odds Ratio (OR)|1.0195||||0.9437|TWO_SIDED|95.0|0.6|1.7|||Cochran-Mantel-Haenszel|Stratification factors comprised RET M918T mutational status (positive, negative, and unknown).||||1.7|0.6|0.9437
70860931|NCT00433511|141208118|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.17|TWO_SIDED|95.0|0.71|1.06||Two-sided; based on stratified test using stratification factors at randomization.|Regression, Cox||Hazard ratio: Arm C/Arm A|The primary objective of this trial was to determine whether the addition of bevacizumab improved IDFS. A two-step hierarchical approach was used. In the 1st step, Arm C was to be compared to Arm A. If Arm C significantly improved IDFS relative to Arm A, then in the 2nd step, a comparison of Arm B to Arm A was to be performed. If the treatment in both Arm C and Arm B significantly improved IDFS relative to Arm A, then a comparison of Arm C to Arm B was to be performed with respect to IDFS.||1.06|0.71|0.17
71132709|NCT03058692|141768565|OTHER|||||||0.75||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.75
71132710|NCT03058692|141768566|OTHER|||||||0.5||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.50
71132711|NCT03058692|141768566|OTHER|||||||0.5||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.50
71132712|NCT03058692|141768567|OTHER||||||>|0.99||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||>.99
71132713|NCT03058692|141768567|OTHER||||||>|0.99||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||>.99
71132714|NCT03058692|141768568|OTHER|||||||0.81||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.81
70860932|NCT00433511|141208119|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.41|TWO_SIDED|95.0|0.68|1.17||Two-sided; based on stratified test using stratification factors at randomization.|Regression, Cox||Hazard ratio: Arm C/Arm A|||1.17|0.68|0.41
70860933|NCT00433511|141208119|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.92|TWO_SIDED|95.0|0.77|1.33||Two-sided; based on stratified test using stratification factors at randomization.|Regression, Cox||Hazard ratio: Arm B/Arm A|||1.33|0.77|0.92
70947607|NCT02647645|141395948|SUPERIORITY|Power calculation was based on similar studies of cognitive training with transcranial direct current stimulation (tDCS).||||||0.34||||||Probability associated with the test of the interaction between participants' performance and session number in repeated measures analysis of covariance. In light of small sample size, estimated effect size was also calculated (d = .71).|ANCOVA|Test was adjusted for age, gender, race, education, CD4 count, and log viral load.||Results are overall estimated marginal means from repeated measures analysis of covariance with treatment group as a fixed factor and age, gender, race, education, CD4 count, and log viral load as covariates.||||0.34
70947608|NCT02647645|141395949|SUPERIORITY|Power calculation was based on the investigators' estimate of the impact of cognitive training with transcranial direct current stimulation (tDCS) on subjective cognitive problems, as similar studies were not available to develop effect size estimates.||||||0.33||||||Probability associated with the test of the interaction between participants' performance and session number in repeated measures analysis of covariance. In light of small sample size, estimated effect size was also calculated (d = .63).|ANCOVA|Test was adjusted for age, gender, race, education, CD4 count, and log viral load.||Results are overall estimated marginal means from repeated measures analysis of covariance with treatment group as a fixed factor and age, gender, race, education, CD4 count, and log viral load as covariates.||||0.33
71132715|NCT03058692|141768568|OTHER|||||||0.47||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.47
71132716|NCT03058692|141768569|OTHER|||||||0.0061||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.0061
71132717|NCT03058692|141768569|OTHER|||||||0.28||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.28
71132718|NCT03058692|141768570|OTHER|||||||0.36||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.36
71132719|NCT03058692|141768570|OTHER|||||||0.32||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.32
70860934|NCT00433511|141208119|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.36|TWO_SIDED|95.0|0.72|1.13||Two-sided; based on stratified test using stratification factors at randomization|Regression, Cox||Hazard ratio: Arm C/Arm B|||1.13|0.72|0.36
70947609|NCT00356811|141395950|SUPERIORITY_OR_OTHER||percentage of participants|50.9|||||TWO_SIDED|95.0|37.3|64.4|||||The estimated value represents the percentage of participants with a confirmed CR or PR.|||64.4|37.3|
71132720|NCT03058692|141768571|OTHER|||||||0.42||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.42
71132721|NCT03058692|141768571|OTHER|||||||0.26||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.26
70860935|NCT03139604|141208121|OTHER||Odds Ratio (OR)|1.45||||0.0782|TWO_SIDED|95.0|0.959|2.204||Not adjusted for multiplicity with interim and final analyses|Cochran-Mantel-Haenszel|||binomial distribution||2.204|0.959|0.0782
70860936|NCT02007512|141208162|OTHER||Hazard Ratio (HR)|0.82||||0.3631|TWO_SIDED|95.0|0.535|1.257|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||1.257|0.535|0.3631
70947610|NCT04367480|141396018|SUPERIORITY||Mean Difference (Final Values)|1.05|STANDARD_ERROR_OF_MEAN|0.81||0.199|TWO_SIDED|95.0|-0.56|2.67|||ANCOVA|||"Missing data were accounted for using multiple imputation (MI) with the fully conditional specification (FCS) method. 100 replicates were imputed.~ANCOVA analysis was applied within each replicate. SAS PROC MI and MIANALYZE were used to calculate the reported estimates. (N: Active TENS=71, Placebo TENS=70)"||2.67|-0.56|0.199
70947611|NCT04367480|141396019|SUPERIORITY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.36||0.302|TWO_SIDED|95.0|-0.34|1.08|||ANCOVA|||Analysis on the Study Completers (N: Active TENS=67, Placebo TENS=62)||1.08|-0.34|0.302
70947612|NCT04367480|141396019|SUPERIORITY||Mean Difference (Final Values)|1.37|STANDARD_ERROR_OF_MEAN|0.85||0.112|TWO_SIDED|95.0|-0.33|3.08|||ANCOVA|||Subgroup analysis on participants who reported at least 4 out of 10 at baseline for Hot/Burning Pain. (N: Active TENS=22, Placebo TENS=22)||3.08|-0.33|0.112
71132722|NCT03058692|141768572|OTHER|||||||0.53||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.53
71132723|NCT03058692|141768572|OTHER|||||||0.56||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.56
71132724|NCT03058692|141768573|OTHER|||||||0.97||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.97
71132725|NCT03058692|141768573|OTHER|||||||0.62||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.62
71132726|NCT03058692|141768574|OTHER|||||||0.15||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.15
71132727|NCT03058692|141768574|OTHER|||||||0.18||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.18
71132728|NCT03058692|141768575|OTHER|||||||0.94||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.94
70860937|NCT02007512|141208162|OTHER||Hazard Ratio (HR)|1.022||||0.9212|TWO_SIDED|95.0|0.659|1.586|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||1.586|0.659|0.9212
70860938|NCT02007512|141208163|OTHER||Hazard Ratio (HR)|0.442||||0.0335|TWO_SIDED|95.0|0.205|0.955|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||0.955|0.205|0.0335
70947613|NCT04367480|141396020|SUPERIORITY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.35||0.351|TWO_SIDED|95.0|-0.37|1.02|||ANCOVA|||Analysis on the Study Completers (N: Active TENS=67, Placebo TENS=62)||1.02|-0.37|0.351
70947614|NCT04367480|141396020|SUPERIORITY||Mean Difference (Final Values)|1.21|STANDARD_ERROR_OF_MEAN|0.78||0.128|TWO_SIDED|95.0|-0.36|2.79|||ANCOVA|||Subgroup analysis was performed on participants who reported at least 4 out of 10 at baseline for Sharp/Shooting Pain. (N: Active TENS=24, Placebo TENS=23)||2.79|-0.36|0.128
70947615|NCT04367480|141396021|SUPERIORITY||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|0.38||0.166|TWO_SIDED|95.0|-0.22|1.27|||ANCOVA|||Analysis on the Study Completers (N: Active TENS=67, Placebo TENS=62)||1.27|-0.22|0.166
70860939|NCT02007512|141208163|OTHER||Hazard Ratio (HR)|0.554||||0.1936|TWO_SIDED|95.0|0.225|1.363|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||1.363|0.225|0.1936
70860940|NCT02007512|141208180|OTHER||Hazard Ratio (HR)|0.928||||0.7378|TWO_SIDED|95.0|0.599|1.438|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||1.438|0.599|0.7378
71132729|NCT03058692|141768575|OTHER|||||||||||||||||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.|||
71132730|NCT03058692|141768576|OTHER|||||||0.14||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.14
71132731|NCT03058692|141768576|OTHER|||||||0.26||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.26
71132732|NCT03058692|141768577|OTHER|||||||0.72||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.72
71132733|NCT03058692|141768577|OTHER|||||||0.31||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.31
71132734|NCT03058692|141768578|OTHER|||||||0.31||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.31
71132735|NCT03058692|141768578|OTHER|||||||0.22||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.22
71132736|NCT03058692|141768579|OTHER|||||||0.16||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.16
71132737|NCT03058692|141768579|OTHER|||||||0.44||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.44
71132738|NCT03058692|141768580|OTHER|||||||0.67||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.67
70860941|NCT02007512|141208180|OTHER||Hazard Ratio (HR)|0.968||||0.8817|TWO_SIDED|95.0|0.632|1.483|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||1.483|0.632|0.8817
70860942|NCT02007512|141208181|OTHER||Hazard Ratio (HR)|0.522||||0.127|TWO_SIDED|95.0|0.224|1.217|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||1.217|0.224|0.1270
70860943|NCT02007512|141208181|OTHER||Hazard Ratio (HR)|0.37||||0.0359|TWO_SIDED|95.0|0.143|0.961|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||0.961|0.143|0.0359
71132739|NCT03058692|141768580|OTHER|||||||0.48||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.48
71132740|NCT03058692|141768581|OTHER||||||<|0.001||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||<0.001
71132741|NCT03058692|141768581|OTHER|||||||0.62||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.62
71132742|NCT03058692|141768582|OTHER|||||||0.0093||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.0093
71132743|NCT03058692|141768582|OTHER|||||||0.51||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.51
71132744|NCT03058692|141768583|OTHER|||||||0.54||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.54
71132745|NCT03058692|141768583|OTHER|||||||0.43||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.43
71132746|NCT03058692|141768584|OTHER|||||||0.44||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.44
70860944|NCT04824365|141208252|SUPERIORITY||Mean Difference (Final Values)|-0.3379|STANDARD_ERROR_OF_MEAN|0.1438||0.0197|TWO_SIDED|95.0|-0.6213|-0.0545|||ANOVA|two-way ANOVA||||-0.0545|-0.6213|0.0197
70860945|NCT04824365|141208253|SUPERIORITY||Mean Difference (Final Values)|0.0381|STANDARD_ERROR_OF_MEAN|0.1129||0.736|TWO_SIDED|95.0|-0.1843|0.2605|||ANOVA|Two-way ANOVA||||0.2605|-0.1843|0.736
70860946|NCT04824365|141208254|SUPERIORITY||Mean Difference (Final Values)|0.3131|STANDARD_ERROR_OF_MEAN|0.1049||0.003|TWO_SIDED|95.0|0.1069|0.5193|||ANOVA|Two-way ANOVA||||0.5193|0.1069|0.0030
70860947|NCT04824365|141208255|SUPERIORITY||Mean Difference (Final Values)|1.704|STANDARD_ERROR_OF_MEAN|0.3035|<|0.0001|TWO_SIDED|95.0|1.105|2.302|||ANOVA|Two-way ANOVA||||2.302|1.105|<0.0001
71132747|NCT03058692|141768584|OTHER|||||||0.014||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.014
71132748|NCT03058692|141768585|OTHER||||||<|0.001||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||<0.001
71132749|NCT03058692|141768585|OTHER|||||||0.96||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.96
71132750|NCT03058692|141768586|OTHER|||||||0.65||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.65
71132751|NCT03058692|141768586|OTHER|||||||0.53||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.53
71132752|NCT03058692|141768587|OTHER|||||||0.35||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.35
71132753|NCT03058692|141768587|OTHER|||||||0.66||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.66
71132754|NCT03058692|141768588|OTHER|||||||0.86||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.86
71132755|NCT03058692|141768588|OTHER|||||||0.53||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.53
71132756|NCT00571974|141768612|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||One-sided exact binomial test to compare the observed response rate to the 20% rate envisioned under the original null hypothesis.|One-sided exact binomial test|Because all but one subject responded to treatment, the Fisher's exact test was addedd.||The Simon two-stage minimax design with 9 subjects in the first stage and 8 subjects in the second stage, yielding 17 subjects overall. This design's early termination rule was ≤3/9 responses in the first stage, and its success criterion was ≥7/17 responses overall. This design had 80% power at 5% alpha to distinguish an efficacious 50% response rate from a null-hypothesis 20% response rate.||||0.0001
71132757|NCT00799266|141768620|SUPERIORITY|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|0.414||||0.0392|TWO_SIDED|95.0|0.022|0.806|||ANCOVA|||Lumbar Spine BMD Z-score at Month 12||0.806|0.022|0.0392
70860948|NCT04824365|141208256|SUPERIORITY||Mean Difference (Final Values)|1.633|STANDARD_ERROR_OF_MEAN|0.3362|<|0.0001|TWO_SIDED|95.0|0.9672|2.298|||ANOVA|Two-way ANOVA||||2.298|0.9672|<0.0001
70860949|NCT04824365|141208257|SUPERIORITY||Mean Difference (Final Values)|1.964|STANDARD_ERROR_OF_MEAN|0.2473|<|0.0001|TWO_SIDED|95.0|1.477|2.452|||ANOVA|Two-way ANOVA||||2.452|1.477|<0.0001
70860950|NCT04824365|141208258|SUPERIORITY||Mean Difference (Final Values)|-0.4831|STANDARD_ERROR_OF_MEAN|0.2382||0.0435|TWO_SIDED|95.0|-0.9521|-0.01413|||ANOVA|Two-way ANOVA||||-0.01413|-0.9521|0.0435
70860951|NCT04824365|141208259|SUPERIORITY||Mean Difference (Final Values)|-0.05102|STANDARD_ERROR_OF_MEAN|0.2711||0.8509|TWO_SIDED|95.0|-0.5862|0.4841|||ANOVA|Two-way ANOVA||||0.4841|-0.5862|0.8509
70860952|NCT04824365|141208260|SUPERIORITY||Mean Difference (Final Values)|0.1339|STANDARD_ERROR_OF_MEAN|0.3177||0.6738|TWO_SIDED|95.0|-0.4921|0.76|||ANOVA|Two-way ANOVA||||0.7600|-0.4921|0.6738
70860953|NCT04824365|141208261|SUPERIORITY||Mean Difference (Final Values)|0.3095|STANDARD_ERROR_OF_MEAN|0.2832||0.2753|TWO_SIDED|95.0|-0.2478|0.8669|||ANOVA|Two-way ANOVA||||0.8669|-0.2478|0.2753
70860954|NCT04824365|141208262|SUPERIORITY||Mean Difference (Final Values)|-1.426|STANDARD_ERROR_OF_MEAN|0.2636|<|0.0001|TWO_SIDED|95.0|-1.948|-0.9043|||ANOVA|Two-way ANOVA||||-0.9043|-1.948|<0.0001
70872119|NCT02155608|141229494|SUPERIORITY|||||||0.07||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 3.35, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.07
70947616|NCT04367480|141396021|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.39||0.492|TWO_SIDED|95.0|-0.51|1.05|||ANCOVA|||Subgroup analysis was performed on participants who reported at least 4 out of 10 at baseline for Numbness. (N: Active TENS=60, Placebo TENS=50)||1.05|-0.51|0.492
70947617|NCT04367480|141396022|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.38||0.622|TWO_SIDED|95.0|-0.56|0.94|||ANCOVA|||Analysis on the Study Completers (N: Active TENS=67, Placebo TENS=62)||0.94|-0.56|0.622
71132758|NCT00799266|141768621|SUPERIORITY|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|0.29||||0.1322|TWO_SIDED|95.0|-0.094|0.673|||ANCOVA|||Lumbar Spine BMD Z-score at Month 6||0.673|-0.094|0.1322
71132759|NCT00799266|141768622|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|1.979||||0.0409|TWO_SIDED|95.0|0.089|3.869|||ANCOVA|||Lumbar Spine BMC at Month 6||3.869|0.089|0.0409
71132760|NCT00799266|141768622|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|2.155||||0.234|TWO_SIDED|95.0|-1.488|5.798|||ANCOVA|||Lumbar Spine BMC at Month 12||5.798|-1.488|0.2340
71132761|NCT00799266|141768623|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|34.058||||0.3827|TWO_SIDED|95.0|-45.385|113.502|||ANCOVA|||Total Body BMC at Month 6||113.502|-45.385|0.3827
71132762|NCT00799266|141768623|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|80.741||||0.2634|TWO_SIDED|95.0|-65.602|227.084|||ANCOVA|||Total Body BMC at Month 12||227.084|-65.602|0.2634
70947618|NCT04367480|141396022|SUPERIORITY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.43||0.587|TWO_SIDED|95.0|-0.61|1.08|||ANCOVA|||Subgroup analysis was performed on participants who reported at least 4 out of 10 at baseline for Tingling. (N: Active TENS=55, Placebo TENS=50)||1.08|-0.61|0.587
70947619|NCT04367480|141396023|SUPERIORITY||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.34||0.058|TWO_SIDED|95.0|-0.02|1.31|||ANCOVA|||Analysis on the Study Completers (N: Active TENS=67, Placebo TENS=62)||1.31|-0.02|0.058
71132763|NCT00799266|141768624|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-211.782||||0.0631|TWO_SIDED|95.0|-363.765|-59.8|||ANCOVA|||Serum P1NP at Month 6||-59.800|-363.765|0.0631
71132764|NCT00799266|141768624|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-381.132||||0.0049|TWO_SIDED|95.0|-565.416|-196.848|||ANCOVA|||Serum P1NP at Month 12||-196.848|-565.416|0.0049
71132765|NCT00799266|141768625|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-11.223||||0.2129|TWO_SIDED|95.0|-22.595|0.149|||ANCOVA|||Serum BSAP at Month 6||0.149|-22.595|0.2129
71132766|NCT00799266|141768625|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-20.435||||0.0215|TWO_SIDED|95.0|-33.96|-6.909|||ANCOVA|||Serum BSAP at Month 12||-6.909|-33.960|0.0215
71132767|NCT00799266|141768626|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-20.938||||0.0254|TWO_SIDED|95.0|-33.766|-8.11|||ANCOVA|||Serum NTX at Month 6||-8.110|-33.766|0.0254
71132768|NCT00799266|141768626|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-27.574||||0.0002|TWO_SIDED|95.0|-39.037|-16.111|||ANCOVA|||Serum NTX at Month 12||-16.111|-39.037|0.0002
71132769|NCT00799266|141768627|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-1.874||||0.2178|TWO_SIDED|95.0|-3.931|0.182|||ANCOVA|||Serum TRAP-5b at Month 6||0.182|-3.931|0.2178
71132770|NCT00799266|141768627|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-1.837||||0.184|TWO_SIDED|95.0|-4.103|0.429|||ANCOVA|||Serum TRAP-5b at Month 12||0.429|-4.103|0.1840
71132771|NCT00799266|141768628|OTHER|The number and percentage of patients with new vertebral fractures at Month 12 were presented by treatment group and between-treatment differences were evaluated using Fisher's exact test.||||||0.2258|||||||Fisher Exact|||New vertebral fractures at Month 12||||0.2258
71132772|NCT00799266|141768629|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-0.018||||0.318|TWO_SIDED|95.0|-0.055|0.019|||ANCOVA|||Vertebral morphometry at Month 12||0.019|-0.055|0.3180
71132773|NCT00799266|141768630|OTHER|Presented by treatment group and evaluated using a logistic regression model with treatment, pooled centers, underlying condition treated with glucocorticoids and baseline pain score as explanatory variables.|Odds Ratio (OR)|0.45||||0.5226|TWO_SIDED|95.0|0.04|5.2|||Regression, Logistic|||Reduction in Pain at Month 3||5.20|0.04|0.5226
71132774|NCT00799266|141768630|OTHER|Presented by treatment group and evaluated using a logistic regression model with treatment, pooled centers, underlying condition treated with glucocorticoids and baseline pain score as explanatory variables.|Odds Ratio (OR)|999.99||||0.522|TWO_SIDED|95.0|0.01|999.99||\>999.99 (\<0.01, \>999.99)|Regression, Logistic|||Reduction in Pain at Month 6||999.99|0.01|0.5220
71132775|NCT00799266|141768630|OTHER|Presented by treatment group and evaluated using a logistic regression model with treatment, pooled centers, underlying condition treated with glucocorticoids and baseline pain score as explanatory variables.|Odds Ratio (OR)|0.52||||0.6019|TWO_SIDED|95.0|0.04|6.22|||Regression, Logistic|||Reduction in Pain at Month 9||6.22|0.04|0.6019
71132776|NCT00799266|141768630|OTHER|Presented by treatment group and evaluated using a logistic regression model with treatment, pooled centers, underlying condition treated with glucocorticoids and baseline pain score as explanatory variables.|Odds Ratio (OR)|0.45||||0.9652|TWO_SIDED|0.9652|0.01|999.99||0.45 (\<0.01, \>999.99)|Regression, Logistic|||Reduction in Pain at Month 12||999.99|0.01|0.9652
71132777|NCT00799266|141768631|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-0.04||||0.5165|TWO_SIDED|95.0|-0.17|0.09|||ANCOVA|||2nd metacarpal cortical width at Month 12||0.09|-0.17|0.5165
71132778|NCT01340586|141768638|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.787|||||TWO_SIDED|90.0|0.616|1.006||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over Normal Renal Function||1.006|0.616|
71132779|NCT01340586|141768638|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.904|||||TWO_SIDED|90.0|0.697|1.173||||||Geometric Mean Ratio: ESRD Dose after hemodialysis over Normal Renal Function||1.173|0.697|
71132780|NCT01340586|141768638|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.871|||||TWO_SIDED|90.0|0.723|1.049||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over ESRD Dose after hemodialysis||1.049|0.723|
70860955|NCT01052844|141208289|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Chi-squared|||Complete protection from nausea and vomiting (CP) was defined as the absence of any episode of nausea or vomiting and no use of rescue medication. CP was further defined as either acute (ACP), when occurring during the first 24 hours after chemotherapy; delayed (DCP), when occurring during the period from days 2 through 5 after chemotherapy; or overall, when occurring over the entire period of the study (first 120 hours).||||0.04
71132781|NCT01340586|141768640|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.187|||||TWO_SIDED|90.0|0.907|1.553||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over Normal Renal Function||1.553|0.907|
71132782|NCT01340586|141768640|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.389|||||TWO_SIDED|90.0|1.097|1.758||||||Geometric Mean Ratio: ESRD Dose after hemodialysis over Normal Renal Function||1.758|1.097|
70860956|NCT01052844|141208290|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||We evaluated associations between categorical variables using the Chi-Square test||||0.06
70860957|NCT03463031|141208291|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17||0.001|TWO_SIDED|95.0|-0.9|-0.2|||Mixed Models Analysis|||||-0.2|-0.9|0.001
70860958|NCT03463031|141208292|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.0|-0.3|||Mixed Models Analysis|||||-0.3|-1.0|<0.001
70860959|NCT03463031|141208293|SUPERIORITY||Least Square Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA|||||-0.1|-0.5|< 0.001
70860960|NCT03463031|141208294|SUPERIORITY||Least Square Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.233|TWO_SIDED|95.0|-0.6|0.1|||Mixed Models Analysis|||||0.1|-0.6|0.233
70860961|NCT02537574|141208306|SUPERIORITY||Odds Ratio (OR)|1.02|STANDARD_ERROR_OF_MEAN|0.264||0.94|TWO_SIDED|95.0|0.61|1.7|||Regression, Logistic|||||1.70|0.61|0.940
70860962|NCT02537574|141208306|SUPERIORITY||Odds Ratio (OR)|0.8|STANDARD_ERROR_OF_MEAN|0.207||0.383|TWO_SIDED|95.0|0.48|1.33|||Regression, Logistic|||||1.33|0.48|0.383
70860963|NCT00048061|141208313|NON_INFERIORITY_OR_EQUIVALENCE|The monthly dosing regimen (Ibandronate 50/50 mg monthly) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to -1 percentage point.|Mean Difference (Final Values)|0.615||||0.045|TWO_SIDED|95.0|0.013|1.216|||ANOVA||Treatment effect is the difference in the mean values of the monthly oral dose regimens (Ibandronate 50/50) and the active-control.|||1.216|0.013|0.045
70860964|NCT00048061|141208313|NON_INFERIORITY_OR_EQUIVALENCE|The monthly dosing regimen (Ibandronate 100 mg) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to -1 percentage point.|Mean Difference (Final Values)|0.297||||0.338|TWO_SIDED|95.0|-0.312|0.906|||ANOVA||Treatment effect is the difference in the mean values of the monthly oral dose regimens (Ibandronate 100 mg) and the active-control|||0.906|-0.312|0.338
70860965|NCT00048061|141208313|NON_INFERIORITY_OR_EQUIVALENCE|The monthly dosing regimen (Ibandronate 150 mg) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to -1 percentage point.|Mean Difference (Final Values)|1.0||||0.001|TWO_SIDED|95.0|0.395|1.605|||ANOVA||Treatment effect is the difference in the mean values of the monthly oral dose regimens (Ibandronate 150 mg) and the active-control.|||1.605|0.395|0.001
70947620|NCT04367480|141396023|SUPERIORITY||Mean Difference (Final Values)|1.35|STANDARD_ERROR_OF_MEAN|0.82||0.11|TWO_SIDED|95.0|-0.32|3.02|||ANCOVA|||Subgroup analysis was performed on participants who reported at least 4 out of 10 at baseline for Cramping. (N: Active TENS=18, Placebo TENS=18)||3.02|-0.32|0.110
71132783|NCT01340586|141768640|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.855|||||TWO_SIDED|90.0|0.707|1.033||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over ESRD Dose after hemodialysis||1.033|0.707|
71132784|NCT01340586|141768642|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.165|||||TWO_SIDED|90.0|0.88|1.543||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over Normal Renal Function||1.543|0.880|
70860966|NCT02675231|141208329|SUPERIORITY|The abemaciclib plus trastuzumab plus fulvestrant arm will be compared to the standard of care (SOC) chemotherapy plus trastuzumab arm first, and the abemaciclib doublet arm will be compared to the SOC chemotherapy plus trastuzumab arm only if the test for the triplet vs the SOC chemotherapy plus trastuzumab arm is significant.||||||0.0506|||||||Log Rank|Stratified by number of prior systemic regimens for advanced breast cancer (2 to 3 versus(vs) \>3) and status of disease(measurable vs non-measurable).||PFS analysis was planned after approximately 165 PFS events occurred in the enrolled population, yielding greater than or equal to (≥) 80% power assuming a Hazard ration (HR) of 0·667 at an experiment-wise 2-sided alpha level of 0·2.||||0.0506
71132785|NCT01340586|141768642|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.357|||||TWO_SIDED|90.0|1.066|1.728||||||Geometric Mean Ratio: ESRD Dose after hemodialysis over Normal Renal Function||1.728|1.066|
70860967|NCT02675231|141208329|SUPERIORITY|The abemaciclib plus trastuzumab plus fulvestrant arm will be compared to the standard of care (SOC) chemotherapy plus trastuzumab arm first, and the abemaciclib doublet arm will be compared to the SOC chemotherapy plus trastuzumab arm only if the test for the triplet vs the SOC chemotherapy plus trastuzumab arm is significant.||||||0.7695|||||||Log Rank|Stratified by number of prior systemic regimens for advanced breast cancer (2 to 3 versus(vs) \>3) and status of disease(measurable vs non-measurable).||PFS analysis was planned after approximately 165 PFS events occurred in the enrolled population, yielding greater than or equal to (≥) 80% power assuming a Hazard ration (HR) of 0·667 at an experiment-wise 2-sided alpha level of 0·2.||||0.7695
70860968|NCT02675231|141208330|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.241|TWO_SIDED|95.0|0.36|1.3|||Log Rank||Stratified by the number of previous regimens (excluding single-agent endocrine therapy) for advanced breast cancer and the status of disease (measurable vs. non-measurable).|||1.30|0.36|0.241
70860969|NCT02675231|141208330|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.313|TWO_SIDED|95.0|0.38|1.36|||Log Rank||Stratified by the number of previous regimens (excluding single-agent endocrine therapy) for advanced breast cancer and the status of disease (measurable vs. non-measurable).|||1.36|0.38|0.313
70860970|NCT02675231|141208331|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.104|TWO_SIDED|95.0|0.42|1.08|||Log Rank||Stratified by the number of previous regimens (excluding single-agent endocrine therapy) for advanced breast cancer and the status of disease (measurable vs. non-measurable).|||1.08|0.42|0.104
70860971|NCT02675231|141208331|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.12|TWO_SIDED|95.0|0.43|1.1|||Log Rank||Stratified by the number of previous regimens (excluding single-agent endocrine therapy) for advanced breast cancer and the status of disease (measurable vs. non-measurable).|||1.10|0.43|0.120
70872120|NCT02155608|141229495|SUPERIORITY|||||||0.55|||||||Mixed Models Analysis|Group: F = .36, df = 1/52||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.55
71132786|NCT01340586|141768642|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.858|||||TWO_SIDED|90.0|0.707|1.042||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over ESRD Dose after hemodialysis||1.042|0.707|
70947621|NCT00730015|141396026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.72|||<|0.0001|TWO_SIDED|95.0|3.41|17.47||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference in the proportion of 12-week CSBM overall responders between patients taking the 145-μg dose and those taking placebo. The power, adjusted for multiplicity, was expected to be at least 90% based on study NCT00402337(MCP-103-201) data.||17.47|3.41|<0.0001
70872121|NCT02155608|141229495|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|Time: F = .09, df = 1/52||Phase 1a: Outcomes were fitted via a mixed model with group, time, and group-by-time interactions to test for treatment effects.||||.34
71132787|NCT03671213|141768664|SUPERIORITY|Non-inferiority is demonstrated if the 90% LB \> -10.0%. If non-inferiority was met, superiority could be tested. Superiority is demonstrated if 97.5% LB \> 0.0%.||||||||||||||||For missing data in both Arms/Groups, multiple imputation was performed for the primary CCS analysis|Device group differences and two-sided 90% and 97.5% confidence interval lower bounds (LB) adjusting for propensity score (PS) subclass based on PS subclass weights (ATT). Non-inferiority is demonstrated if the 90% LB \> -10.0%. Superiority is demonstrated if 97.5% LB \> 0.0%. Two-sided 97.5% LB is evaluated rather than two-sided 95.0% LB since the superiority type 1 error is split between testing superiority in terms of Month 24 CCS and then separately for a set of superiority secondary endpoints with type 1 error control maintained through the use of Hochberg approach (following demonstration of non-inferiority).|||
71132788|NCT03223337|141768674|OTHER||Ratio of Geometric Least Square(LS) Mean|1.9973|||||TWO_SIDED|90.0|1.1063|3.6057|||||Ratio of Geometric LS Mean for GSK1278863 (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||3.6057|1.1063|
71132789|NCT03223337|141768674|OTHER||Ratio of Geometric LS Mean|1.6471|||||TWO_SIDED|90.0|1.1267|2.4079|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.4079|1.1267|
71132790|NCT03223337|141768674|OTHER||Ratio of Geometric LS Mean|1.6404|||||TWO_SIDED|90.0|1.0744|2.5048|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.5048|1.0744|
71132791|NCT03223337|141768674|OTHER||Ratio of Geometric LS Mean|1.4931|||||TWO_SIDED|90.0|1.0876|2.0498|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.0498|1.0876|
71132792|NCT03223337|141768674|OTHER||Ratio of Geometric LS Mean|1.6222|||||TWO_SIDED|90.0|1.1594|2.2696|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.2696|1.1594|
71132793|NCT03223337|141768674|OTHER||Ratio of Geometric LS Mean|1.3145|||||TWO_SIDED|90.0|0.9896|1.7462|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.7462|0.9896|
71132794|NCT03223337|141768675|OTHER||Ratio of Geometric LS Mean|1.4574|||||TWO_SIDED|90.0|1.035|2.0523|||||Ratio of Geometric LS Mean for GSK1278863 (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.0523|1.0350|
71132795|NCT03223337|141768675|OTHER||Ratio of Geometric LS Mean|1.9375|||||TWO_SIDED|90.0|1.3919|2.6968|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.6968|1.3919|
71132796|NCT03223337|141768675|OTHER||Ratio of Geometric LS Mean|1.8312|||||TWO_SIDED|90.0|1.3342|2.5133|||||Ratio of Geometric LS Mean for GSK2506104 (M3) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.5133|1.3342|
71132797|NCT03223337|141768675|OTHER||Ratio of Geometric LS Mean|2.003|||||TWO_SIDED|90.0|1.4654|2.7378|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.7378|1.4654|
71132798|NCT03223337|141768675|OTHER||Ratio of Geometric LS Mean|1.7113|||||TWO_SIDED|90.0|1.2818|2.2847|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.2847|1.2818|
71132799|NCT03223337|141768675|OTHER||Ratio of Geometric LS Mean|1.974|||||TWO_SIDED|90.0|1.5365|2.536|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.5360|1.5365|
71132800|NCT03223337|141768675|OTHER||Ratio of Geometric LS Mean|1.4603|||||TWO_SIDED|90.0|0.9081|2.3484|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.3484|0.9081|
71132801|NCT03223337|141768678|OTHER||Ratio of Geometric LS Mean|1.9973|||||TWO_SIDED|90.0|1.1061|3.6066|||||Ratio of Geometric LS Mean for GSK1278863 (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||3.6066|1.1061|
71132802|NCT03223337|141768678|OTHER||Ratio of Geometric LS Mean|1.6509|||||TWO_SIDED|90.0|1.1285|2.415|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.4150|1.1285|
71132803|NCT03223337|141768678|OTHER||Ratio of Geometric LS Mean|1.6421|||||TWO_SIDED|90.0|1.0732|2.5125|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.5125|1.0732|
71132804|NCT03223337|141768678|OTHER||Ratio of Geometric LS Mean|1.5169|||||TWO_SIDED|90.0|1.0994|2.093|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.0930|1.0994|
71132805|NCT03223337|141768678|OTHER||Ratio of Geometric LS Mean|1.624|||||TWO_SIDED|90.0|1.1599|2.2736|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.2736|1.1599|
71132806|NCT03223337|141768678|OTHER||Ratio of Geometric LS Mean|1.3143|||||TWO_SIDED|90.0|0.9887|1.747|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.7470|0.9887|
71132807|NCT03223337|141768679|OTHER||Ratio of Geometric LS Mean|1.4566|||||TWO_SIDED|90.0|1.0344|2.0513|||||Ratio of Geometric LS Mean for GSK1278863 (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.0513|1.0344|
71132808|NCT03223337|141768679|OTHER||Ratio of Geometric LS Mean|1.9478|||||TWO_SIDED|90.0|1.3935|2.7224|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.7224|1.3935|
71132809|NCT03223337|141768679|OTHER||Ratio of Geometric LS Mean|1.8392|||||TWO_SIDED|90.0|1.335|2.534|||||Ratio of Geometric LS Mean for GSK2506104 (M3) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.5340|1.3350|
70947622|NCT00730015|141396026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.21|||<|0.0001|TWO_SIDED|95.0|3.14|16.59||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference in the proportion of 12-week CSBM overall responders between patients taking the 290-μg dose and those taking placebo. The power, adjusted for multiplicity, was expected to be greater than 96% based on study NCT00402337(MCP-103-201) data.||16.59|3.14|<0.0001
70954369|NCT03568318|141411396|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|29.5|||<|0.001|TWO_SIDED|95.0|22.8|36.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||36.3|22.8|<0.001
71132810|NCT03223337|141768679|OTHER||Ratio of Geometric LS Mean|2.0161|||||TWO_SIDED|90.0|1.4711|2.763|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.7630|1.4711|
71132811|NCT03223337|141768679|OTHER||Ratio of Geometric LS Mean|1.7303|||||TWO_SIDED|90.0|1.2932|2.3151|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.3151|1.2932|
71132812|NCT03223337|141768679|OTHER||Ratio of Geometric LS Mean|1.987|||||TWO_SIDED|90.0|1.5426|2.5594|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.5594|1.5426|
71132813|NCT03223337|141768679|OTHER||Ratio of Geometric LS Mean|1.4646|||||TWO_SIDED|90.0|0.9086|2.3609|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.3609|0.9086|
71132814|NCT03223337|141768680|OTHER||Ratio of Geometric LS Mean|1.9786|||||TWO_SIDED|90.0|1.0557|3.7084|||||Ratio of Geometric LS Mean for GSK1278863 (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||3.7084|1.0557|
71132815|NCT03223337|141768680|OTHER||Ratio of Geometric LS Mean|1.2791|||||TWO_SIDED|90.0|0.9241|1.7705|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.7705|0.9241|
71132816|NCT03223337|141768680|OTHER||Ratio of Geometric LS Mean|1.2487|||||TWO_SIDED|90.0|0.8675|1.7974|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.7974|0.8675|
71132817|NCT03223337|141768680|OTHER||Ratio of Geometric LS Mean|1.1802|||||TWO_SIDED|90.0|0.9165|1.5197|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.5197|0.9165|
71132818|NCT03223337|141768680|OTHER||Ratio of Geometric LS Mean|1.2726|||||TWO_SIDED|90.0|0.952|1.7012|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.7012|0.9520|
71132819|NCT03223337|141768680|OTHER||Ratio of Geometric LS Mean|1.0409|||||TWO_SIDED|90.0|0.7927|1.3668|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.3668|0.7927|
71132820|NCT03223337|141768681|OTHER||Ratio of Geometric LS Mean|1.0097|||||TWO_SIDED|90.0|0.7122|1.4316|||||Ratio of Geometric LS Mean for GSK1278863 (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.4316|0.7122|
71132821|NCT03223337|141768681|OTHER||Ratio of Geometric LS Mean|1.7852|||||TWO_SIDED|90.0|1.2498|2.5498|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.5498|1.2498|
71132822|NCT03223337|141768681|OTHER||Ratio of Geometric LS Mean|1.7337|||||TWO_SIDED|90.0|1.2343|2.4353|||||Ratio of Geometric LS Mean for GSK2506104 (M3) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.4353|1.2343|
71132823|NCT03223337|141768681|OTHER||Ratio of Geometric LS Mean|1.7628|||||TWO_SIDED|90.0|1.2898|2.4092|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.4092|1.2898|
71132824|NCT03223337|141768681|OTHER||Ratio of Geometric LS Mean|1.6413|||||TWO_SIDED|90.0|1.2055|2.2347|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.2347|1.2055|
71132825|NCT03223337|141768681|OTHER||Ratio of Geometric LS Mean|1.8289|||||TWO_SIDED|90.0|1.3992|2.3904|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.3904|1.3992|
70860972|NCT02675231|141208332|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.049|TWO_SIDED|95.0|0.42|1.0|||Log Rank||Stratified by the number of previous regimens (excluding single-agent endocrine therapy) for advanced breast cancer and the status of disease (measurable vs. non-measurable).|||1.00|0.42|0.049
71132826|NCT03223337|141768681|OTHER||Ratio of Geometric LS Mean|1.3367|||||TWO_SIDED|90.0|0.8288|2.1557|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.1557|0.8288|
71132827|NCT03223337|141768682|OTHER||Ratio of Geometric LS Mean|0.905|||||TWO_SIDED|90.0|0.69|1.1869|||||Ratio of Geometric LS Mean for GSK1278863 (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.1869|0.6900|
71132828|NCT03223337|141768682|OTHER||Ratio of Geometric LS Mean|0.7415|||||TWO_SIDED|90.0|0.5617|0.9787|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||0.9787|0.5617|
71132829|NCT03223337|141768682|OTHER||Ratio of Geometric LS Mean|0.7299|||||TWO_SIDED|90.0|0.4387|1.2145|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.2145|0.4387|
71132830|NCT03223337|141768682|OTHER||Ratio of Geometric LS Mean|1.1703|||||TWO_SIDED|90.0|0.9|1.5219|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.5219|0.9000|
71132831|NCT03223337|141768682|OTHER||Ratio of Geometric LS Mean|0.9585|||||TWO_SIDED|90.0|0.6664|1.3786|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.3786|0.6664|
71132832|NCT03223337|141768682|OTHER||Ratio of Geometric LS Mean|1.0004|||||TWO_SIDED|90.0|0.7833|1.2778|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.2778|0.7833|
71132833|NCT03223337|141768683|OTHER||Ratio of Geometric LS Mean|1.0574|||||TWO_SIDED|90.0|0.7876|1.4197|||||Ratio of Geometric LS Mean for GSK1278863 (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.4197|0.7876|
71132834|NCT03223337|141768683|OTHER||Ratio of Geometric LS Mean|1.0143|||||TWO_SIDED|90.0|0.7332|1.4032|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.4032|0.7332|
71132835|NCT03223337|141768683|OTHER||Ratio of Geometric LS Mean|1.038|||||TWO_SIDED|90.0|0.7695|1.4002|||||Ratio of Geometric LS Mean for GSK2506104 (M3) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.4002|0.7695|
71132836|NCT03223337|141768683|OTHER||Ratio of Geometric LS Mean|1.3427|||||TWO_SIDED|90.0|0.7635|2.3615|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.3615|0.7635|
71132837|NCT03223337|141768683|OTHER||Ratio of Geometric LS Mean|1.0296|||||TWO_SIDED|90.0|0.6996|1.5151|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.5151|0.6996|
71132838|NCT03223337|141768683|OTHER||Ratio of Geometric LS Mean|1.2721|||||TWO_SIDED|90.0|0.8409|1.9245|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.9245|0.8409|
71132839|NCT03223337|141768683|OTHER||Ratio of Geometric LS Mean|1.2072|||||TWO_SIDED|90.0|0.9398|1.5508|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.5508|0.9398|
71132840|NCT03223337|141768684|OTHER||Median Difference (Final Values)|0.0||||0.6822|TWO_SIDED|90.0|-1.0|0.5||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK1278863 (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||0.50|-1.00|0.6822
71132841|NCT03223337|141768684|OTHER||Median Difference (Final Values)|0.0||||0.5767|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2391220 (M2)(Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|0.5767
71132842|NCT03223337|141768684|OTHER||Median Difference (Final Values)|0.0||||0.588|TWO_SIDED|90.0|-1.0|1.5||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2487818 (M4)(Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.50|-1.00|0.5880
71132843|NCT03223337|141768684|OTHER||Median Difference (Final Values)|0.0||||0.7716|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2506102 (M5)(Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|0.7716
71132844|NCT03223337|141768684|OTHER||Median Difference (Final Values)|0.5||||0.4093|TWO_SIDED|90.0|-1.0|2.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2531398 (M6) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.00|-1.00|0.4093
71132845|NCT03223337|141768684|OTHER||Median Difference (Final Values)|0.0||||0.9837|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2531401 (M13) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|0.9837
71132846|NCT03223337|141768685|OTHER||Median Difference (Final Values)|0.0||||0.6224|TWO_SIDED|90.0|-1.0|0.5||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK1278863 (Mild hepatic impairment participants versus Healthy participants) has been presented.|||0.50|-1.00|0.6224
71132847|NCT03223337|141768685|OTHER||Median Difference (Final Values)|0.0||||0.8042|TWO_SIDED|90.0|-1.0|0.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2391220 (M2) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||0.00|-1.00|0.8042
71132848|NCT03223337|141768685|OTHER||Median Difference (Final Values)|0.0||||0.8423|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2506104 (M3) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|0.8423
71132849|NCT03223337|141768685|OTHER||Median Difference (Final Values)|0.0||||0.5207|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2487818 (M4) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|0.5207
71132850|NCT03223337|141768685|OTHER||Median Difference (Final Values)|0.0||||0.8423|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2506102 (M5) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|0.8423
71132851|NCT03223337|141768685|OTHER||Median Difference (Final Values)|0.0||||1|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2531398 (M6) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|1.0000
71132852|NCT03223337|141768685|OTHER||Median Difference (Final Values)|0.0||||0.8042|TWO_SIDED|90.0|0.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2531401 (M13) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.00|0.00|0.8042
71132853|NCT01362608|141768704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.69|||<|0.0001|TWO_SIDED|95.0|-28.2|-11.2|||ANCOVA|||||-11.2|-28.2|<0.0001
71132854|NCT01362608|141768705|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26||||0.0043|TWO_SIDED|95.0|0.1|0.71|||Regression, Cox|||||0.71|0.10|0.0043
71132855|NCT01336140|141768723|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Chi-squared|||"We calculated that a minimum of 248 subjects are needed to attain 80% power to detect 70% reduction in the incidence of the primary endpoint (diarrhea), assuming an event rate of 15% in the control group (2-tailed α = 0.05). We targeted enrolling 300 patients to allow some room for error in our assumptions.~null hypothesis: incidence of diarrhea is no different between the aminophylline arm and the placebo arm."||||0.002
71132856|NCT01336140|141768724|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
71132857|NCT01336140|141768725|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
71132858|NCT01336140|141768726|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Chi-squared|||||||1
71132859|NCT00699608|141768729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||0.267||95.0|-2.74|0.76|||ANCOVA|ANCOVA used (fixed effects: adjusted period baseline, participant baseline, age, gender, period and treatment group; random effect: participant).||||0.76|-2.74|0.267
71132860|NCT02588261|141768770|SUPERIORITY||Hazard Ratio (HR)|1.611||||0.992|TWO_SIDED|95.0|1.086|2.391|||Log Rank|||Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using log-rank test stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025. Hazard ratio based on Cox proportional hazards model. Assuming proportional hazards, HR \< 1 indicated a reduction in hazard rate in favor of ASP8273 treatment group.||2.391|1.086|0.992
70860973|NCT02675231|141208332|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.153|TWO_SIDED|95.0|0.48|1.12|||Log Rank||Stratified by the number of previous regimens (excluding single-agent endocrine therapy) for advanced breast cancer and the status of disease (measurable vs. non-measurable).|||1.12|0.48|0.153
70947623|NCT00634842|141396038|NON_INFERIORITY_OR_EQUIVALENCE|The primary hypothesis was that there would be no difference in efficacy as measured by the proportion of subjects reaching HbA1c level \< 7% between the two FPG titration arms (70-90 mg/dL and 80-110 mg/dL, respectively) with a non-inferiority margin of 20%. If non-inferiority of the 70-90mg/dL arm was established, superiority was to be tested using a Logistic regression model with baseline HbA1c as a covariate. Superiority was to be concluded if the odds ratio was significantly greater than 1.|Odds Ratio (OR)|1.86||||0.0411||95.0|1.03|3.37|||Test for Difference in Proportions|||To show non-inferiority for the primary endpoint, 100 subjects per group provides 80% power to show that the 95% CI for the difference of proportions between treatments is within the 20% margin under the assumption of equality of proportions. It is also sufficient to show superiority under the assumption that the first proportion is greater than the second by at least 20%. With a predicted withdrawal rate of 15%, 236 subjects were needed based on a treatment ratio of 1:1 for the two treatments.||3.37|1.03|0.0411
71132861|NCT02588261|141768772|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using stratified Cochran-Mantel-Haenszel (CMH) test, stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025.||||1.000
71132862|NCT02588261|141768773|SUPERIORITY||Hazard Ratio (HR)|1.674||||0.998|TWO_SIDED|95.0|1.165|2.406|||Log Rank|||Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using log-rank test stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025. Hazard ratio based on Cox proportional hazards model. Assuming proportional hazards, HR \< 1 indicated a reduction in hazard rate in favor of ASP8273 treatment group.||2.406|1.165|0.998
70860974|NCT02675231|141208337|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.232|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||||||0.232
70947624|NCT00634842|141396039|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis was that there would be no difference in efficacy as measured by the proportion of subjects reaching HbA1c level \<= 6.5% between the two FPG titration arms (70-90 mg/dL and 80-110 mg/dL, respectively) with a non-inferiority margin of 20%. If non-inferiority of the 70-90mg/dL arm was established, superiority was to be tested using a Logistic regression model with baseline HbA1c as a covariate. Superiority was to be concluded if the odds ratio was significantly greater than 1.|Odds Ratio (OR)|2.34||||0.0064||95.0|1.27|4.3|||Regression, Logistic|||||4.30|1.27|0.0064
71132863|NCT02588261|141768774|SUPERIORITY|||||||0.839|||||||Cochran-Mantel-Haenszel|||Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using stratified Cochran-Mantel-Haenszel (CMH) test, stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025.||||0.839
71132864|NCT02588261|141768775|SUPERIORITY||Hazard Ratio (HR)|1.298||||0.78|TWO_SIDED|95.0|0.661|2.548|||Log Rank|||Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using log-rank test stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025. Hazard ratio based on Cox proportional hazards model. Assuming proportional hazards, HR \< 1 indicated a reduction in hazard rate in favor of ASP8273 treatment group.||2.548|0.661|0.780
71132865|NCT02287467|141768788|SUPERIORITY||Odds Ratio (OR)|1.25||||0.33|TWO_SIDED|95.0|0.79|1.97|||Regression, Logistic|Adjusted for baseline clinical status, region, and participation in the pilot study.|Odds ratio is hIVIG vs. placebo. A value greater than 1 favors the hIVIG group.|Odds ratio of being in a better category, as assessed using a proportional odds model. Multiple imputation techniques were used to impute an outcome for 4 patients for whom the outcome was unknown.||1.97|0.79|.33
71132866|NCT02287467|141768789|SUPERIORITY||Odds Ratio (OR)|0.95||||0.84|TWO_SIDED|95.0|0.61|1.48|||Regression, Logistic|Adjusted for baseline clinical status, region, and participation in the pilot study.|Odds ratio is for hIVIG vs placebo. An odds ratio greater than 1 favors the hIVIG group.|Odds ratio for being in a better category, from a proportional odds model||1.48|0.61|.84
71132867|NCT02287467|141768790|SUPERIORITY||Odds Ratio (OR)|0.87||||0.52|TWO_SIDED|95.0|0.57|1.33|||Regression, Cox|adjusted for baseline clinical status, region, and participation in the pilot study.|Odds ratio is for hIVIG vs. placebo. An odds ratio \> 1 favors the hIVIG group.|Odds ratio for being in a better group, from a proportional odds model.||1.33|0.57|.52
71132868|NCT02287467|141768791|SUPERIORITY||Odds Ratio (OR)|1.49||||0.2|TWO_SIDED|95.0|0.81|2.74|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in the pilot study.|Odds ratio for hIVIG vs placebo. An odds ratio \> 1.0 favors the hIVIG group.|||2.74|0.81|.20
71132869|NCT02287467|141768792|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.44|TWO_SIDED|95.0|0.85|1.45|||Regression, Cox|Stratified by baseline clinical status, region, and participation in the pilot study.|hazard ratio is hIVIG vs placebo; a hazard ratio \>1 favors the hIVIG group.|Deaths during hospitalization are censored after day 7.||1.45|.85|.44
71132870|NCT02287467|141768793|SUPERIORITY||Hazard Ratio (HR)|1.72||||0.4|TWO_SIDED|95.0|0.48|6.15|||Regression, Cox|stratified by baseline clinical status, region, and participation in pilot study|hazard ratio is for hIVIG vs placebo; a hazard ratio \< 1.0 favors the hIVIG group.|||6.15|.48|.40
71132871|NCT02287467|141768794|SUPERIORITY||Odds Ratio (OR)|0.87||||0.74|TWO_SIDED|95.0|0.38|1.98|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|odds ratio is for hIVIG vs placebo; an odds ratio \> 1.0 favors hIVIG|||1.98|.38|.74
71132872|NCT02287467|141768795|SUPERIORITY||Mean Difference (Net)|0.14||||0.49|TWO_SIDED|95.0|-0.26|0.54|||Regression, Linear|Adjusted for baseline RNA, geographic region, and influenza subtype|Change is calculated as day 3 - baseline. Difference in changes is hIVIG - placebo.|||.54|-.26|.49
71132873|NCT02287467|141768796|SUPERIORITY||Odds Ratio (OR)|0.97||||0.93|TWO_SIDED|95.0|0.5|1.97|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study.|Odds ratio is for hIVIG vs placebo.|||1.97|0.5|.93
71132874|NCT02287467|141768797|SUPERIORITY||Odds Ratio (OR)|0.92||||0.81|TWO_SIDED|95.0|0.5|1.82|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|odds ratio is for hIVIG group vs placebo|||1.82|0.5|.81
71132875|NCT02287467|141768798|SUPERIORITY||Odds Ratio (OR)|1.17||||0.55|TWO_SIDED|95.0|0.7|1.95|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in the pilot study|Odds ratio (hIVIG vs placebo) of being in a better category. An odds ratio \> 1 favors the hIVIG group.|Proportional odds for being in a better category||1.95|0.70|.55
70947625|NCT00634842|141396040|SUPERIORITY_OR_OTHER||LSMean|-0.271||||0.0019||95.0|-0.441|-0.101|||ANCOVA|The analyses for HbA1c were adjusted for baseline HbA1c values.||||-0.101|-0.441|0.0019
71132876|NCT02287467|141768799|SUPERIORITY||Odds Ratio (OR)|1.12||||0.77|TWO_SIDED|95.0|0.5|2.31|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|odds ratio is for hIVIG vs placebo|||2.31|.5|.77
71132877|NCT02287467|141768800|SUPERIORITY||Odds Ratio (OR)|1.32||||0.34|TWO_SIDED|95.0|0.7|2.34|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|odds ratio is expressed as hIVIG vs placebo|||2.34|0.7|.34
71132878|NCT02287467|141768801|SUPERIORITY||Odds Ratio (OR)|0.9||||0.73|TWO_SIDED|95.0|0.5|1.62||adjusted for baseline clinical status, region, and participation in pilot study|Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|odds ratio (hIVIG vs placebo) is for being in a better category. An odds ratio \>1 favors the hIVIG group.|||1.62|.50|.73
71132879|NCT02287467|141768802|SUPERIORITY||Odds Ratio (OR)|0.94||||0.82|TWO_SIDED|95.0|0.55|1.59|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in the pilot study.|Odds ratio (hIVIG vs placebo) is for being in a better category.|Multiple imputation was used to estimate the outcome for 3 participants for whom the outcome was partially unknown.||1.59|0.55|.82
70860975|NCT02675231|141208338|SUPERIORITY||Least Square (LS) Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|2.4||0.689|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Global health status||||0.689
70860976|NCT02675231|141208338|SUPERIORITY||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|2.3||0.141|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Functional scales: Physical functioning||||0.141
70860977|NCT02675231|141208338|SUPERIORITY||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|3.3||0.095|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Functional scale: Role functioning||||0.095
70860978|NCT02675231|141208338|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|2.5||0.591|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Functional scale: Emotional functioning||||0.591
70860979|NCT02675231|141208338|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|2.1||0.935|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Functional scale: Cognitive functioning||||0.935
70860980|NCT02675231|141208338|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|2.7||0.578|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Functional scale: Social functioning||||0.578
70947626|NCT02007200|141396042|SUPERIORITY_OR_OTHER||||||<|0.005|||||||Linear Repeated Measures Model|||||||<0.005
70947627|NCT04182113|141396050|SUPERIORITY||Mean Difference (Net)|-0.042||||0.32|TWO_SIDED|95.0|-0.129|0.044||Not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-test comparing Target vs. Foil activity following 1Hz rTMS to Target vs. Foil activity following 20 Hz rTMS stimulation.||0.044|-0.129|0.32
70860981|NCT02675231|141208338|SUPERIORITY||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|2.8||0.308|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Fatigue||||0.308
70947628|NCT04182113|141396050|SUPERIORITY||Mean Difference (Net)|0.043||||0.25|TWO_SIDED|95.0|-0.03|0.12||Not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-test between Target vs. Foil activation following 1 Hz rTMS and Target vs. Foil activation following Sham stimulation..||0.12|-0.03|0.25
70947629|NCT04182113|141396050|SUPERIORITY||Mean Difference (Net)|0.078||||0.13|TWO_SIDED|95.0|-0.024|0.181||Not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-test between Target vs. Foil activity following 20 Hz rTMS and Target vs. Foil activity following Sham stimulation.||0.181|-0.024|0.13
70947630|NCT04182113|141396051|SUPERIORITY||Mean Difference (Net)|0.018||||0.038|TWO_SIDED|95.0|0.001|0.034||Not corrected for multiple comparisons.|t-test, 2 sided|||Paired t-test comparing precuneus connectivity following 1Hz rTMS to precuneus connectivity following 20 Hz rTMS stimulation.||0.034|0.001|0.038
70947631|NCT04182113|141396051|SUPERIORITY||Mean Difference (Net)|0.009||||0.44|TWO_SIDED|95.0|-0.015|0.033|||t-test, 2 sided|||Paired t-test comparing precuneus connectivity following 1Hz rTMS to precuneus connectivity following 20 Hz rTMS stimulation.||0.033|-0.015|0.44
70947632|NCT04182113|141396051|SUPERIORITY||Mean Difference (Net)|-0.012||||0.25|TWO_SIDED|95.0|-0.032|0.009|||t-test, 2 sided|||Paired t-test comparing precuneus connectivity following 20Hz rTMS to precuneus connectivity following sham stimulation.||0.009|-0.032|0.25
71132880|NCT02287467|141768803|SUPERIORITY||Odds Ratio (OR)|3.19||||0.02|TWO_SIDED|95.0|1.21|8.42|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|Odds ratio (hIVIG vs placebo) for a better outcome. An odds ratio \> 1 favors the hIVIG group.|Multiple imputation was used to estimate the outcome for one participant.||8.42|1.21|.02
71132881|NCT02287467|141768804|SUPERIORITY||ratio of geometric means|1.5||||0.18|TWO_SIDED|95.0|0.84|2.7|||Mixed Models Analysis|longitudinal regression with adjustment for baseline titer|Ratio of hIVIG group to placebo group. A ratio \> 1.0 indicates higher titers for the hIVIG group.|HAI measurements were log-transformed to compute treatment differences and the model was adjusted for baseline titer.||2.7|0.84|.18
71132882|NCT02287467|141768805|SUPERIORITY||ratio of geometric means|1.31||||0.13|TWO_SIDED|95.0|0.93|1.8|||Mixed Models Analysis|longitudinal analysis of log-transformed titers adjust for baseline titer.|Ratio of geometric means of hIVIG vs placebo. A ratio \>1.0 indicates higher titers in the hIVIG group on day 7.|||1.8|0.93|.13
71132883|NCT02287467|141768806|SUPERIORITY||ratio of geometric means|0.94||||0.78|TWO_SIDED|95.0|0.58|1.5|||Mixed Models Analysis|log-transformed titers adjusted for baseline titer|ratio of geometric mean for hIVIG vs placebo. A ratio \> 1.0 indicates higher titers at day 7 for the hIVIG group.|||1.5|0.58|.78
71132884|NCT00900666|141768807|NON_INFERIORITY_OR_EQUIVALENCE|a priori power calculation suggested N=26 for each group.||||||0.761|TWO_SIDED|95.0||||p\<0.05 threshold|ANOVA|Correlations with walking speed and time since injury were initially performed to determine whether ANCOVA would be be more appropriate.||ANOVA||||0.761
71132885|NCT00900666|141768808|SUPERIORITY_OR_OTHER|||||||0.896||95.0|||||ANOVA|||||||.896
71132886|NCT00684775|141768828|SUPERIORITY||Odds Ratio (OR)|6.0|||=|0.002|TWO_SIDED|95.0|1.44|25.0|||General Estimating Equation (GEE)|||||25.0|1.44|=0.002
71132887|NCT00684775|141768829|SUPERIORITY|||||||0.0081|||||||t-test, 2 sided|||||||0.0081
70860982|NCT02675231|141208338|SUPERIORITY||LS Mean Difference|4.1|STANDARD_ERROR_OF_MEAN|2.0||0.043|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Nausea and vomiting||||0.043
70947633|NCT04182113|141396052|SUPERIORITY||Mean Difference (Net)|2.7||||0.2|TWO_SIDED|95.0|-1.6|6.9||Not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-test of scene recognition performance accuracy following 1Hz rTMS to accuracy following 20 Hz rTMS.||6.9|-1.6|0.20
71132888|NCT00684775|141768830|SUPERIORITY||Odds Ratio (OR)|1.34||||0.56|TWO_SIDED|95.0|0.5|3.6|||General Estimating Equation (GEE)|||||3.6|.5|0.56
71132889|NCT00684775|141768831|SUPERIORITY||Odds Ratio (OR)|1.45|||=|0.41|TWO_SIDED|95.0|0.6|3.53|||General Estimating Equation (GEE)|||||3.53|.6|=0.41
70947634|NCT04182113|141396052|SUPERIORITY||Mean Difference (Net)|4.0||||0.17|TWO_SIDED|95.0|-1.9|9.9||Not corrected for multiple comparisons.|t-test, 2 sided|||Paired t-test of scene recognition performance accuracy following 1Hz rTMS to accuracy following sham rTMS.||9.9|-1.9|0.17
70860983|NCT02675231|141208338|SUPERIORITY||LS Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|3.0||0.026|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Pain||||0.026
70860984|NCT02675231|141208338|SUPERIORITY||LS Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|2.8||0.276|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Dyspnoea||||0.276
70947635|NCT04182113|141396052|SUPERIORITY||Mean Difference (Net)|-1.3||||0.77|TWO_SIDED|95.0|-10.8|8.2||Not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-test of scene recognition performance accuracy following 20Hz rTMS to accuracy following 20 Hz rTMS.||8.2|-10.8|0.77
71132890|NCT00684775|141768832|SUPERIORITY||Odds Ratio (OR)|1.19||||0.75|TWO_SIDED|95.0|0.42|3.36|||General Estimating Equation (GEE)|||||3.36|.42|0.75
71132891|NCT00684775|141768833|SUPERIORITY|||||||0.1543|||||||t-test, 2 sided|||||||0.1543
71132892|NCT00684775|141768834|SUPERIORITY||Odds Ratio (OR)|1.82||||0.15|TWO_SIDED|95.0|0.81|4.1|||General Estimating Equation (GEE)|||||4.1|.81|0.15
71132893|NCT00666406|141768835|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.173|||||TWO_SIDED|90.0|1.089|1.262||||||||1.262|1.089|
71132894|NCT00666406|141768836|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.139|||||TWO_SIDED|90.0|1.043|1.243||||||||1.243|1.043|
71132895|NCT00666406|141768837|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.06|||||TWO_SIDED|90.0|0.866|1.297||||||||1.297|0.866|
71132896|NCT00666406|141768838|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.071|||||TWO_SIDED|90.0|0.972|1.179||||||||1.179|0.972|
71132897|NCT00666406|141768839|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.171|||||TWO_SIDED|90.0|1.099|1.247||||||||1.247|1.099|
70860985|NCT02675231|141208338|SUPERIORITY||LS Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|3.1||0.041|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Insomnia||||0.041
70947636|NCT01667406|141396053|OTHER|Fishers exact conditional test was used to confirm significance|Mean Difference (Final Values)|6.0|||||ONE_SIDED|95.0||||||||Data presented using descriptive statistics. Confidence intervals were derived for the difference between the means of different doses.||||
71132898|NCT00666406|141768840|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.135|||||TWO_SIDED|90.0|1.092|1.18||||||||1.180|1.092|
71132899|NCT00666406|141768841|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.036|||||TWO_SIDED|90.0|0.857|1.253||||||||1.253|0.857|
71132900|NCT00666406|141768842|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.093|||||TWO_SIDED|90.0|1.007|1.186||||||||1.186|1.007|
71132901|NCT00666406|141768843|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.854|||||TWO_SIDED|90.0|0.798|0.913||||||||0.913|0.798|
71132902|NCT00666406|141768844|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.881|||||TWO_SIDED|90.0|0.847|0.916||||||||0.916|0.847|
71132903|NCT00666406|141768845|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.964|||||TWO_SIDED|90.0|0.799|1.164||||||||1.164|0.799|
71132904|NCT00666406|141768846|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.915|||||TWO_SIDED|90.0|0.841|0.995||||||||0.995|0.841|
71132905|NCT00666406|141768847|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.177|||||TWO_SIDED|90.0|1.104|1.256||||||||1.256|1.104|
71132906|NCT00666406|141768848|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.152|||||TWO_SIDED|90.0|1.039|1.277||||||||1.277|1.039|
71132907|NCT00666406|141768849|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.182|||||TWO_SIDED|90.0|1.029|1.359||||||||1.359|1.029|
70947637|NCT01667406|141396053|OTHER||||||<|0.05|||||||Fisher Exact|||Phase 2||||<0.05
71132908|NCT00666406|141768850|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.133|||||TWO_SIDED|90.0|1.01|1.27||||||||1.270|1.010|
71132909|NCT00666406|141768851|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.008|||||TWO_SIDED|90.0|0.969|1.05||||||||1.050|0.969|
71132910|NCT00666406|141768852|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.964|||||TWO_SIDED|90.0|0.843|1.102||||||||1.102|0.843|
71132911|NCT00666406|141768853|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.038|||||TWO_SIDED|90.0|0.926|1.163||||||||1.163|0.926|
71132912|NCT00666406|141768854|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.015|||||TWO_SIDED|90.0|0.901|1.144||||||||1.144|0.901|
71132913|NCT00666406|141768855|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.178|||||TWO_SIDED|90.0|1.106|1.254||||||||1.254|1.106|
71132914|NCT00666406|141768856|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.152|||||TWO_SIDED|90.0|1.038|1.279||||||||1.279|1.038|
71132915|NCT00666406|141768857|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.183|||||TWO_SIDED|90.0|1.027|1.362||||||||1.362|1.027|
71132916|NCT00666406|141768858|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.133|||||TWO_SIDED|90.0|1.012|1.27||||||||1.270|1.012|
71132917|NCT00666406|141768859|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.009|||||TWO_SIDED|90.0|0.964|1.056||||||||1.056|0.964|
71132918|NCT00666406|141768860|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.971|||||TWO_SIDED|90.0|0.849|1.112||||||||1.112|0.849|
71132919|NCT00666406|141768861|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.02|||||TWO_SIDED|90.0|0.938|1.109||||||||1.109|0.938|
71132920|NCT00666406|141768862|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.996|||||TWO_SIDED|90.0|0.894|1.111||||||||1.111|0.894|
71132921|NCT00666406|141768863|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.0|||||TWO_SIDED|90.0|1.0|1.0||||||||1.000|1.000|
71132922|NCT00666406|141768864|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.303|||||TWO_SIDED|90.0|0.841|2.02||||||||2.020|0.841|
71132923|NCT00666406|141768865|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.724|||||TWO_SIDED|90.0|0.304|1.728||||||||1.728|0.304|
71132924|NCT00666406|141768866|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.059|||||TWO_SIDED|90.0|0.442|2.539||||||||2.539|0.442|
71132925|NCT00666406|141768867|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.862|||||TWO_SIDED|90.0|0.807|0.92||||||||0.920|0.807|
71132926|NCT00666406|141768868|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.855|||||TWO_SIDED|90.0|0.73|1.002||||||||1.002|0.730|
71132927|NCT00666406|141768869|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.984|||||TWO_SIDED|90.0|0.788|1.228||||||||1.228|0.788|
71132928|NCT00666406|141768870|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.911|||||TWO_SIDED|90.0|0.8|1.039||||||||1.039|0.800|
71132929|NCT06964165|141768871|OTHER||Difference in pre-IDS ORR|-39.0|||||TWO_SIDED|80.0|-56.8|-17.7|||||||Confidence interval was calculated using the unstratified Miettinen-Nurminen method.|-17.7|-56.8|
71132930|NCT01514201|141768900|OTHER|This was descriptive in nature. Two of the first 5 patients who were escalated to 175 mg/m2 of temozolomide during the maintenance intra-patient dose escalation had dose-modifying toxicities (DMTs). Since the ad hoc stopping rule was met, intra-patient dose escalation was halted and all subsequent patients were to receive 135 mg/m2 of temozolomide during maintenance.|Percentage of patients with DMTs|40.0|||||TWO_SIDED|||||||||Intra-patient dose escalation of temozolomide during maintenance was assessed based on similar rules employed in traditional 3+3 designs. For example intra-patient dose escalation would be halted if at any time 2 out of first 2-6 patients experienced dose-modifying toxicities at a given dose level or if 4 out of first 12 patients experienced dose-modifying toxicities at a given dose level.||||
71132931|NCT02534909|141768945|OTHER|Bayesian analysis of response rate in serum LDH (period 1 completers only)|Median response rate|99.0|||||TWO_SIDED|95.0|81.9|100.0|||||95% Credibility Interval for Response Rate|Up to Week 4||100.0|81.9|
70947638|NCT01667406|141396053|OTHER||Odds Ratio (OR)|0.05|||<|0.05|ONE_SIDED|95.0|||||Regression, Logistic||Estimate of difference in success rates and estimate of odds ratio for success were derived, with P value comparing 2 treatment groups, 95% conﬁdence intervals.|Phase 3||||<0.05
71132932|NCT02534909|141768946|OTHER||Geometric LS mean Ratio to Baseline|0.19|||<|0.001|TWO_SIDED|95.0|0.15|0.23|||Mixed Models Analysis||The longitudinal mixed effects model included timepoint, log baseline as a covariate and the log baseline by timepoint interaction. C5 variant status was included as a categorical covariate.|Period 1 Day 29 serum LDH levels||0.23|0.15|<0.001
71132933|NCT02534909|141768946|OTHER||Geometric LS mean Ratio to Baseline|0.19|||<|0.001|TWO_SIDED|95.0|0.15|0.23|||Mixed Models Analysis||The longitudinal mixed effects model included timepoint, log baseline as a covariate and the log baseline by timepoint interaction. C5 variant status was included as a categorical covariate.|Period 2 Day 365 serum LDH levels||0.23|0.15|<0.001
71132934|NCT02534909|141768946|OTHER||Geometric LS mean Ratio to Baseline|0.17|||<|0.001|TWO_SIDED|95.0|0.14|0.2|||Mixed Models Analysis||The longitudinal mixed effects model included timepoint, log baseline as a covariate and the log baseline by timepoint interaction. C5 variant status was included as a categorical covariate.|Period 3 Day 1429 serum LDH levels||0.20|0.14|<0.001
71132935|NCT02534909|141768946|OTHER||Geometric LS mean Ratio to Baseline|0.19|||<|0.001|TWO_SIDED|95.0|0.15|0.24|||Mixed Models Analysis||The longitudinal mixed effects model included timepoint, log baseline as a covariate and the log baseline by timepoint interaction. C5 variant status was included as a categorical covariate.|Period 4 Day 141 serum LDH levels||0.24|0.15|<0.001
71132936|NCT00566852|141768956|SUPERIORITY_OR_OTHER|||||||0.059||||||Significance level was 0.025.|Wilcoxon (Mann-Whitney)|||Null hypothesis: patients on memantine will experience less decline than patients receiving placebo. Based on a one-sided Wilcoxon rank sum test with alpha=0.025, 221 patients per arm would be required to have 80% statistical power to detect a mean difference of 0.87 in the HVLT-R change scores between the two treatment arms. Assuming that 20% of patients may be ineligible, or die prior to the 24 week assessment, the target sample size for randomization was set to 536.||||0.059
71132937|NCT00566852|141768957|SUPERIORITY|||||||0.0692||||||One-sided significance level of 0.025|Wilcoxon (Mann-Whitney)|||8 weeks||||0.0692
71132938|NCT00566852|141768957|SUPERIORITY|||||||0.4541||||||One-sided significance level of 0.025|Wilcoxon (Mann-Whitney)|||16 weeks||||0.4541
71132939|NCT00566852|141768957|SUPERIORITY|||||||0.397||||||One-sided significance level of 0.025|Wilcoxon (Mann-Whitney)|||52 weeks||||0.3970
71132940|NCT00566852|141768958|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.01|TWO_SIDED|95.0|0.62|0.99|||Gray's test|||A one-sided log-rank test with alpha 0.025 accruing 221 patients/arm with 12 months of follow-up would ensure 98% statistical power to detect a 33% relative reduction in the monthly hazard rate with the use of memantine. Gray's test was used to test for a statistically significant difference in the distribution of neurocognitive failure times and Cox proportional hazards regression model was used to determine hazard ratios and 95% confidence intervals for the treatment difference.||0.99|0.62|0.01
71132941|NCT00566852|141768959|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||Assuming normally distributions, the two sample t-test assuming equal variances would be used to compare the arms at the 0.025 significance level. If normality assumptions were not met, the Wilcoxon rank sum would be used.||||0.77
71132942|NCT00566852|141768960|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.27|TWO_SIDED|95.0|0.87|1.3|||Log Rank|||The stratified log-rank test was used to test for a statistically significant difference in survival distributions with a one-sided alpha of 0.025 . In addition, the Cox proportional hazards regression model was used to determine hazard ratios and 95% confidence intervals for the treatment difference.||1.3|0.87|0.27
70947639|NCT01667406|141396054|OTHER|secondary outcomes were analysed using descriptive statistics.||||||||||||||||Study data were summarised using standard descriptive methods. Continuous variables following a normal distribution have been summarised using mean and SD.|secondary outcomes were analysed using descriptive statistics.|||
70860986|NCT02675231|141208338|SUPERIORITY||LS Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|3.4||0.262|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Appetite loss||||0.262
70860987|NCT02675231|141208338|SUPERIORITY||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|2.7||0.285|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Constipation||||0.285
70860988|NCT02675231|141208338|SUPERIORITY||LS Mean Difference|19.3|STANDARD_ERROR_OF_MEAN|3.2|<|0.001|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Diarrhoea||||< 0.001
70860989|NCT02675231|141208338|SUPERIORITY||LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|3.0||0.18|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Financial difficulties||||0.180
70860990|NCT02675231|141208339|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.02||0.033|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model: Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||||||0.033
70860991|NCT02675231|141208339|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.02||0.275|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model: Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||||||0.275
70860992|NCT02675231|141208340|SUPERIORITY||LS Mean Difference|1.22|STANDARD_ERROR_OF_MEAN|2.02||0.546|TWO_SIDED||||||MMRM Model|||||||0.546
70860993|NCT02675231|141208340|SUPERIORITY||LS Mean Difference|-1.02|STANDARD_ERROR_OF_MEAN|2.1||0.62|TWO_SIDED||||||MMRM Model|||||||0.620
70860994|NCT02220998|141208354|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 120 per treatment group provided 90% power to establish non-inferiority in the SVR12 rates between the SOF/VEL group and the SOF+RBV group. It was based on the assumptions that the non-inferiority margin is 10%, both groups have a SVR12 rate of 94%, and the significance level is 0.025 one-sided.|Difference in proportions|5.2|||||TWO_SIDED|95.0|0.2|10.3|||||Difference in proportions between treatment groups and associated 95% confidence intervals (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions.|||10.3|0.2|
70860995|NCT02220998|141208354|SUPERIORITY_OR_OTHER|||||||0.018||||||P-value was stratified by cirrhosis status and prior treatment experience.|Cochran-Mantel-Haenszel|||The superiority of SOF/VEL for 12 weeks over SOF+RBV for 12 weeks was to be tested if the efficacy of SOF/VEL for 12 weeks was demonstrated to be statistically noninferior to SOF+RBV for 12 weeks (ie, if the lower bound of the 95% CI for the strata-adjusted difference in the proportions between groups was greater than the prespecified noninferiority margin of -10%).||||0.018
70860996|NCT02314143|141208362|OTHER||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.224|4.459|||Cochran-Mantel-Haenszel||The odds ratio for dabrafenib followed by combination therapy versus combination therapy has been presented.|||4.459|0.224|1.0000
70860997|NCT02314143|141208362|OTHER||Odds Ratio (OR)|1.97||||0.4216|TWO_SIDED|95.0|0.382|10.166|||Cochran-Mantel-Haenszel||The odds ratio for trametinib followed by combination therapy versus combination therapy has been presented.|||10.166|0.382|0.4216
71132943|NCT00566852|141768961|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.025|TWO_SIDED|95.0|0.86|1.31|||Log Rank|||The stratified log-rank test was used to test for a statistically significant difference in survival distributions with a one-sided alpha of 0.025 . In addition, the Cox proportional hazards regression model was used to determine hazard ratios and 95% confidence intervals for the treatment difference.||1.31|0.86|0.025
70860998|NCT00873860|141208376|SUPERIORITY_OR_OTHER|||||||0.573||||||Change at Day 92: p-value was based on analysis of variance (ANOVA).|ANOVA|||||||0.573
70860999|NCT00873860|141208376|SUPERIORITY_OR_OTHER|||||||0.64||||||Change at Day 92: p-value was based on ANOVA.|ANOVA|||||||0.640
70861000|NCT00873860|141208376|SUPERIORITY_OR_OTHER|||||||0.224||||||Change at Day 92: p-value was based on ANOVA.|ANOVA|||||||0.224
70861001|NCT00873860|141208377|SUPERIORITY_OR_OTHER|||||||0.4686||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.||||0.4686
70861002|NCT00873860|141208377|SUPERIORITY_OR_OTHER|||||||0.317||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.||||0.3170
70861003|NCT00873860|141208377|SUPERIORITY_OR_OTHER|||||||0.1664||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.||||0.1664
70947640|NCT02768597|141396059|SUPERIORITY|||||||0.552|||||||ANOVA|||||||.552
70947641|NCT02768597|141396060|SUPERIORITY|||||||0.558|||||||ANOVA|||||||.558
71132944|NCT00577824|141768964|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Bonferroni's method was used to adjustment for multiplicity, and significant level was set to 2.5%(two-sided).|ANCOVA|ANCOVA model with treatment group as a factor and baseline value as the covariate.||||||<0.001
70947642|NCT02768597|141396061|SUPERIORITY|||||||0.274|||||||Kruskal-Wallis|||||||.274
70947643|NCT02768597|141396062|SUPERIORITY|||||||0.539|||||||Kruskal-Wallis|||||||.539
70947644|NCT02768597|141396063|SUPERIORITY|||||||0.478|||||||Kruskal-Wallis|||||||.478
70947645|NCT02768597|141396064|SUPERIORITY|||||||0.527|||||||ANOVA|||||||.527
70947646|NCT02768597|141396065|SUPERIORITY|||||||0.823|||||||ANOVA|||||||.823
70947647|NCT02768597|141396066|SUPERIORITY|||||||0.231|||||||ANOVA|||||||.231
70947648|NCT02768597|141396067|SUPERIORITY|||||||0.595|||||||Kruskal-Wallis|||||||.595
70947649|NCT02768597|141396068|SUPERIORITY|||||||0.789|||||||Kruskal-Wallis|||||||.789
70947650|NCT01015677|141396086|SUPERIORITY_OR_OTHER||Differrence in the least squares means|-6.28||||0.488|TWO_SIDED|95.0|-24.2|11.64|||Longitudinal Data Analysis (LDA)|LDA model terms for treatment, week (Weeks 1, 2 and 4), region, and interaction of treatment by week.||||11.64|-24.20|0.488
70947651|NCT01015677|141396086|SUPERIORITY_OR_OTHER||Difference in the least squares means|-17.45||||0.069|TWO_SIDED|95.0|-36.28|1.38|||Longitudinal Data Analysis|LDA model with terms for treatment, week (Weeks 1, 2 and 4), region, and interaction of treatment by week.||||1.38|-36.28|0.069
70947652|NCT01015677|141396089|SUPERIORITY_OR_OTHER||Differrence in the least squares means|-6.05||||0.529|TWO_SIDED|95.0|-25.06|12.96|||Longitudinal Data Analysis (LDA)|LDA model includes terms for treatment, week (Weeks 1, 2 and 4), region, and interaction of treatment by week.||||12.96|-25.06|0.529
70947653|NCT01015677|141396089|SUPERIORITY_OR_OTHER||Difference in the least squares means|-11.22||||0.264|TWO_SIDED|95.0|-31.03|8.59|||Longitudinal Data Analysis|LDA model includes terms for treatment, week (Weeks 1, 2 and 4), region, and interaction of treatment by week.||||8.59|-31.03|0.264
70947654|NCT01015677|141396090|SUPERIORITY_OR_OTHER||Difference in LS means|0.94||||0.827|TWO_SIDED|90.0|-6.19|8.07|||ANCOVA|Analysis of covariance (ANCOVA) with terms for treatment, region, stage of the trial, and baseline value as a covariate in PP population only.||||8.07|-6.19|0.827
70947655|NCT01015677|141396090|SUPERIORITY_OR_OTHER||Difference in the LS means|-14.52||||0.001|TWO_SIDED|90.0|-21.73|-7.32|||ANCOVA|ANCOVA with terms for treatment, region, stage of the trial, and baseline value as a covariate in PP population only.||||-7.32|-21.73|0.001
71132945|NCT00577824|141768965|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Armitage|||||||<0.001
71132946|NCT00577824|141768966|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Armitage|||||||<0.001
71132947|NCT00577824|141768967|SUPERIORITY_OR_OTHER||||||<|0.002||95.0||||No adjustment for multiplicity. Significance level was 5% (two-sided).|ANCOVA|||||||<0.002
71132948|NCT00577824|141768968|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||No adjustment for multiplicity. Significance level was 5% (two-sided).|ANCOVA|||||||0.026
71132949|NCT00577824|141768969|SUPERIORITY_OR_OTHER|||||||0.672||95.0|||||t-test, 2 sided|||||||0.672
71132950|NCT00577824|141768970|SUPERIORITY_OR_OTHER|||||||0.58||95.0|||||t-test, 2 sided|||||||0.580
71132951|NCT00577824|141768971|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||t-test, 2 sided|||||||0.014
71132952|NCT00577824|141768972|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||t-test, 2 sided|||||||0.490
71132953|NCT00577824|141768973|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
71132954|NCT00577824|141768974|SUPERIORITY_OR_OTHER|||||||0.208||95.0|||||t-test, 2 sided|||||||0.208
71132955|NCT00577824|141768976|SUPERIORITY_OR_OTHER|||||||0.708||95.0|||||t-test, 2 sided|||||||0.708
71132956|NCT00577824|141768977|SUPERIORITY_OR_OTHER|||||||0.974||95.0|||||t-test, 2 sided|||||||0.974
71132957|NCT00577824|141768979|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||t-test, 2 sided|||||||0.200
71132958|NCT00577824|141768980|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71132959|NCT00362648|141768984|SUPERIORITY_OR_OTHER||Efficacy = 1-Relative Risk|39.3|||<|0.001||95.0|19.1|54.7||Efficacy\>0%. Based on p\< 1/(1+k), where p is proportion of subjects with outcome in vaccine group relative to total number of subjects with outcome, and k is ratio of follow-up time; placebo / vaccine. Based on conditional binomial approach.|Exact binomial test||Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group.|The number randomized is different from the number analyzed because some data were excluded from the analysis: subjects were classified as unevaluable due to wildtype rotavirus in stool before 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range. Rotavirus gastroenteritis cases are subjects with one or more positive episodes. The most severe positive episode is used for the date of the case.||54.7|19.1|<0.001
71132960|NCT00362648|141768984|SUPERIORITY_OR_OTHER||Efficacy = 1-Relative Risk|48.3|||<|0.001||95.0|22.3|66.1||Efficacy\>0%. Based on p\< 1/(1+k), where p is proportion of subjects with outcome in vaccine group relative to total number of subjects with outcome, and k is ratio of follow-up time; placebo / vaccine. Based on conditional binomial approach.|Exact binomial test||Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group.|The number randomized is different from the number analyzed because some data were excluded from the analysis: subjects were classified as unevaluable due to wildtype rotavirus in stool before 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range. Rotavirus gastroenteritis cases are subjects with one or more positive episodes. The most severe positive episode is used for the date of the case.||66.1|22.3|<0.001
71132961|NCT00362648|141768985|SUPERIORITY_OR_OTHER||Percentage|78.3||||||95.0|71.7|84.0||||||Anti-rotavirus IgA||84.0|71.7|
71132962|NCT00362648|141768985|SUPERIORITY_OR_OTHER||Percentage|18.5||||||95.0|13.3|24.8||||||Serotype G1||24.8|13.3|
71132963|NCT00362648|141768985|SUPERIORITY_OR_OTHER||Percentage|9.0||||||95.0|5.3|14.0||||||Serotype G2||14.0|5.3|
71132964|NCT00362648|141768985|SUPERIORITY_OR_OTHER||Percentage|6.3||||||95.0|3.3|10.8||||||Serotype G3||10.8|3.3|
71132965|NCT00362648|141768985|SUPERIORITY_OR_OTHER||Percentage|26.5||||||95.0|20.3|33.3||||||Serotype G4||33.3|20.3|
71132966|NCT00362648|141768985|SUPERIORITY_OR_OTHER||Percentage|14.4||||||95.0|9.7|20.2||||||Serotype P1A\[8\]||20.2|9.7|
71132967|NCT00362648|141768985|SUPERIORITY_OR_OTHER||Percentage|20.1||||||95.0|14.4|27.0||||||Anti-rotavirus IgA||27.0|14.4|
71132968|NCT00362648|141768985|SUPERIORITY_OR_OTHER||Percentage|0.0||||||95.0|0.0|2.2||||||Serotype G1||2.2|0.0|
71132969|NCT00362648|141768985|SUPERIORITY_OR_OTHER||Percentage|3.0||||||95.0|1.0|6.8||||||Serotype G2||6.8|1.0|
71132970|NCT00362648|141768985|SUPERIORITY_OR_OTHER||Percentage|2.4||||||95.0|0.6|5.9||||||Serotype G3||5.9|0.6|
70861004|NCT00873860|141208377|SUPERIORITY_OR_OTHER|||||||0.3234||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.||||0.3234
70861005|NCT00873860|141208377|SUPERIORITY_OR_OTHER|||||||0.3133||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.||||0.3133
70861006|NCT00873860|141208377|SUPERIORITY_OR_OTHER|||||||0.2108||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.||||0.2108
70861007|NCT00873860|141208384|SUPERIORITY_OR_OTHER|||||||0.934||||||ACQ score \<=0.75, Day 92: Fisher exact test was used to compare all arms.|Fisher Exact|||||||0.934
70861008|NCT00873860|141208384|SUPERIORITY_OR_OTHER|||||||0.592||||||ACQ score \<=0.75, Day 169: Fisher exact test was used to compare all arms.|Fisher Exact|||||||0.592
70861009|NCT00873860|141208389|SUPERIORITY_OR_OTHER|||||||1||||||Day 92: Fisher exact test was used for the analysis.|Fisher Exact|||||||1.0000
70861010|NCT00873860|141208389|SUPERIORITY_OR_OTHER|||||||0.6022||||||Day 92: Fisher exact test was used for the analysis.|Fisher Exact|||||||0.6022
70861011|NCT00873860|141208389|SUPERIORITY_OR_OTHER|||||||1||||||Day 92: Fisher exact test was used for the analysis.|Fisher Exact|||||||1.0000
70861012|NCT00873860|141208389|SUPERIORITY_OR_OTHER|||||||1||||||Day 169: Fisher exact test was used for the analysis.|Fisher Exact|||||||1.0000
70861013|NCT00873860|141208389|SUPERIORITY_OR_OTHER|||||||1||||||Day 169: Fisher exact test was used for the analysis.|Fisher Exact|||||||1.0000
70861014|NCT00873860|141208389|SUPERIORITY_OR_OTHER|||||||1||||||Day 169: Fisher exact test was used for the analysis.|Fisher Exact|||||||1.0000
70861015|NCT00873860|141208390|SUPERIORITY_OR_OTHER|||||||0.551||||||Day 1 to 92: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test|||||||0.551
71132971|NCT00362648|141768985|SUPERIORITY_OR_OTHER||Percentage|2.4||||||95.0|0.6|5.9||||||Serotype G4||5.9|0.6|
70861016|NCT00873860|141208390|SUPERIORITY_OR_OTHER|||||||0.492||||||Day 1 to 92: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test|||||||0.492
70861017|NCT00873860|141208390|SUPERIORITY_OR_OTHER|||||||0.983||||||Day 1 to 92: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test|||||||0.983
70861018|NCT00873860|141208390|SUPERIORITY_OR_OTHER|||||||0.991||||||Day 1 to 169: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test|||||||0.991
70861019|NCT00873860|141208390|SUPERIORITY_OR_OTHER|||||||0.9||||||Day 1 to 169: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test|||||||0.900
70861020|NCT00873860|141208390|SUPERIORITY_OR_OTHER|||||||0.673||||||Day 1 to 169: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test|||||||0.673
70861021|NCT00873860|141208391|SUPERIORITY_OR_OTHER|||||||0.546||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||||||0.546
70861022|NCT00873860|141208391|SUPERIORITY_OR_OTHER|||||||0.534||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||||||0.534
70861023|NCT00873860|141208391|SUPERIORITY_OR_OTHER|||||||0.847||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||||||0.847
70861024|NCT00873860|141208391|SUPERIORITY_OR_OTHER|||||||0.987||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||||||0.987
70861025|NCT00873860|141208391|SUPERIORITY_OR_OTHER|||||||0.992||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||||||0.992
70861026|NCT00873860|141208391|SUPERIORITY_OR_OTHER|||||||0.688||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||||||0.688
70861027|NCT00708071|141208392|SUPERIORITY_OR_OTHER||Difference in Proportions|0.25||||0.143||95.0|-0.04|0.49|||McNemar||Difference in Proportions = SoC - FS VH S/D 4|||0.49|-0.04|0.143
70861028|NCT00708071|141208393|SUPERIORITY_OR_OTHER||Difference in proportions|0.31|||||TWO_SIDED|90.0|0.12|0.48|||||Difference in proportions = SoC - FS VH S/D 4|||0.48|0.12|
70861029|NCT00708071|141208394|SUPERIORITY_OR_OTHER||Difference in proportions|0.111|||||TWO_SIDED|90.0|-0.11|0.32|||||Difference in proportions = SoC - FS VH S/D 4|||0.32|-0.11|
70861030|NCT00708071|141208395|SUPERIORITY_OR_OTHER||Difference in proportions|-0.032|||||TWO_SIDED|90.0|-0.24|0.18|||||Difference in proportions = SoC - FS VH S/D 4|||0.18|-0.24|
71132972|NCT00362648|141768985|SUPERIORITY_OR_OTHER||Percentage|4.7||||||95.0|2.1|9.1||||||Serotype P1A\[8\]||9.1|2.1|
71132973|NCT00362648|141768986|SUPERIORITY_OR_OTHER||Percentage|87.8||||||95.0|80.9|92.9||||||Anti-rotavirus IgA||92.9|80.9|
71132974|NCT00362648|141768986|SUPERIORITY_OR_OTHER||Percentage|32.1||||||95.0|24.2|40.8||||||Serotype G1||40.8|24.2|
71132975|NCT00362648|141768986|SUPERIORITY_OR_OTHER||Percentage|9.9||||||95.0|5.4|16.4||||||Serotype G2||16.4|5.4|
71132976|NCT00362648|141768986|SUPERIORITY_OR_OTHER||Percentage|28.2||||||95.0|20.7|36.8||||||Serotype G3||36.8|20.7|
71132977|NCT00362648|141768986|SUPERIORITY_OR_OTHER||Percentage|18.3||||||95.0|12.1|26.0||||||Serotype G4||26.0|12.1|
71132978|NCT00362648|141768986|SUPERIORITY_OR_OTHER||Percentage|27.5||||||95.0|20.0|36.0||||||Serotype P1A\[8\]||36.0|20.0|
71132979|NCT00362648|141768986|SUPERIORITY_OR_OTHER||Percentage|18.2||||||95.0|12.0|25.8||||||Anti-rotavirus IgA||25.8|12.0|
71132980|NCT00362648|141768986|SUPERIORITY_OR_OTHER||Percentage|2.3||||||95.0|0.5|6.5||||||Serotype G1||6.5|0.5|
71132981|NCT00362648|141768986|SUPERIORITY_OR_OTHER||Percentage|0.8||||||95.0|0.0|4.1||||||Serotype G2||4.1|0.0|
71132982|NCT00362648|141768986|SUPERIORITY_OR_OTHER||Percentage|3.0||||||95.0|0.8|7.6||||||Serotype G3||7.6|0.8|
71132983|NCT00362648|141768986|SUPERIORITY_OR_OTHER||Percentage|0.0||||||95.0|0.0|2.8||||||Serotype G4||2.8|0.0|
71132984|NCT00362648|141768986|SUPERIORITY_OR_OTHER||Percentage|5.3||||||95.0|2.2|10.6||||||Serotype P1A\[8\]||10.6|2.2|
71132985|NCT02123823|141769157|OTHER||Hazard Ratio, log|0.97||||0.9057|TWO_SIDED|95.0|0.57|1.65|||Log Rank|Two-sided log-rank test stratified for visceral involvement.|Cox proportional hazards model stratified for visceral involvement.|||1.65|0.57|0.9057
71132986|NCT02123823|141769160|OTHER||Odds Ratio, log|0.7||||0.5598|TWO_SIDED|95.0|0.2|2.32|||Regression, Logistic|Odds ratio and p-value are obtained from logistic regression model adjusted for visceral involvement at screening.|An odds ratio \>1 indicates a benefit to the xentuzumab arm.|||2.32|0.20|0.5598
71132987|NCT02123823|141769161|OTHER||Hazard Ratio, log|1.03||||0.9146|TWO_SIDED|95.0|0.59|1.8|||Log Rank|Two-sided log-rank test stratified for visceral involvement.|Cox proportional hazards model stratified for visceral involvement.|||1.80|0.59|0.9146
71132988|NCT02123823|141769162|OTHER||Odds Ratio, log|0.7||||0.4008|TWO_SIDED|95.0|0.31|1.59|||Regression, Logistic|Odds ratio and p-value are obtained from logistic regression model adjusted for visceral involvement.|An odds ratio \>1 indicates a benefit to the xentuzumab arm.|||1.59|0.31|0.4008
71132989|NCT03453489|141769167|OTHER|||||||0.837|||||||t-test, 2 sided|||||||0.837
71132990|NCT05870865|141769176|SUPERIORITY||Mean Difference (Final Values)|4.28||||0.5483|TWO_SIDED||||||Mixed Models Analysis|||||||0.5483
71132991|NCT05870865|141769176|SUPERIORITY||Mean Difference (Final Values)|-5.89||||0.4123|TWO_SIDED||||||Mixed Models Analysis|||||||0.4123
71132992|NCT05870865|141769176|SUPERIORITY||Mean Difference (Final Values)|1.66||||0.8177|TWO_SIDED||||||Mixed Models Analysis|||||||0.8177
70861031|NCT00708071|141208396|SUPERIORITY_OR_OTHER||Difference in proportions|0.0|||||TWO_SIDED|90.0|-0.21|0.21|||||Difference in proportions = SoC - FS VH S/D 4|||0.21|-0.21|
70861032|NCT00708071|141208397|SUPERIORITY_OR_OTHER||Difference in proportions|0.038|||||TWO_SIDED|90.0|-0.17|0.24|||||Difference in proportions = SoC - FS VH S/D 4|||0.24|-0.17|
71132993|NCT05870865|141769177|SUPERIORITY||Odds Ratio (OR)|0.66||||0.4601|TWO_SIDED||||||Fisher Exact|||||||0.4601
71132994|NCT05870865|141769177|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0804|TWO_SIDED||||||Fisher Exact|||||||0.0804
71132995|NCT05870865|141769177|SUPERIORITY||Odds Ratio (OR)|1.06|||>|0.9999|TWO_SIDED||||||Fisher Exact|||||||>0.9999
71132996|NCT05870865|141769178|SUPERIORITY||Mean Difference (Final Values)|0.72||||0.2146|TWO_SIDED||||||Mixed Models Analysis|||||||0.2146
71132997|NCT05870865|141769178|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.8851|TWO_SIDED||||||Mixed Models Analysis|||||||0.8851
71132998|NCT05870865|141769178|SUPERIORITY||Mean Difference (Final Values)|0.81||||0.1835|TWO_SIDED||||||Mixed Models Analysis|||||||0.1835
71132999|NCT05870865|141769179|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.7982|TWO_SIDED||||||Mixed Models Analysis|||||||0.7982
71133000|NCT05870865|141769179|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.564|TWO_SIDED||||||Mixed Models Analysis|||||||0.5640
71133001|NCT05870865|141769179|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.2939|TWO_SIDED||||||Mixed Models Analysis|||||||0.2939
71133002|NCT05870865|141769180|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.3579|TWO_SIDED||||||Mixed Models Analysis|||||||0.3579
71133003|NCT05870865|141769180|SUPERIORITY||Mean Difference (Final Values)|-1.4||||0.3466|TWO_SIDED||||||Mixed Models Analysis|||||||0.3466
71133004|NCT05870865|141769180|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.9527|TWO_SIDED||||||Mixed Models Analysis|||||||0.9527
71133005|NCT01868477|141769194|OTHER|difference|Mean Difference (Final Values)|14.4|||||TWO_SIDED|95.0|-24.0|48.16||||||||48.16|-24.0|
71133006|NCT03526146|141769235|SUPERIORITY|||||||0.002|||||||paired t-test|||||||0.002
71133007|NCT03526146|141769236|SUPERIORITY|||||||0.047|||||||paired t-test|||||||0.047
71133008|NCT03526146|141769237|SUPERIORITY|||||||0.006|||||||paired t-test|||||||0.006
71133009|NCT03526146|141769238|SUPERIORITY|||||||0.05|||||||paired t-test|||||||0.05
71133010|NCT03526146|141769239|SUPERIORITY|||||||0.009|||||||paired t-test|||||||0.009
71133011|NCT01717872|141769240|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||MAC blade lifting the tongue versus Miller blade lifting the epiglottis||||>0.05
71133012|NCT01717872|141769241|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71133013|NCT01717872|141769242|SUPERIORITY_OR_OTHER||||||<|0.0004|||||||Wilcoxon (Mann-Whitney)|||||||<0.0004
71133014|NCT02214290|141769243|OTHER||||||<|0.001|||||||ANOVA|post-hoc comparisons were used to determine within-group and between-group differences.||||||<0.001
71133015|NCT02214290|141769244|OTHER||||||<|0.001|||||||ANOVA|post-hoc comparisons were used to determine within-group and between-group differences.||||||<0.001
71133016|NCT02214290|141769245|OTHER||||||<|0.001|||||||ANOVA|post-hoc comparisons were used to determine within-group and between-group differences.||||||<0.001
70861033|NCT00708071|141208398|SUPERIORITY_OR_OTHER|||||||0.645|||||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.645
70861034|NCT00708071|141208399|SUPERIORITY_OR_OTHER|||||||0.103||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.103
70861035|NCT00708071|141208400|SUPERIORITY_OR_OTHER|||||||0.833||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.833
70861036|NCT00708071|141208401|SUPERIORITY_OR_OTHER|||||||0.501||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.501
70861037|NCT00708071|141208402|SUPERIORITY_OR_OTHER|||||||0.247||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.247
70861038|NCT00708071|141208403|SUPERIORITY_OR_OTHER|||||||0.715||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.715
70861039|NCT00708071|141208405|SUPERIORITY_OR_OTHER|||||||0.754||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.754
70861040|NCT00708071|141208406|SUPERIORITY_OR_OTHER|||||||0.388||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.388
70861041|NCT00708071|141208407|SUPERIORITY_OR_OTHER|||||||0.234||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.234
70861042|NCT00708071|141208408|SUPERIORITY_OR_OTHER|||||||0.688||90.0||||Two-sided Wilcoxon paired sample tests|Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.688
70861043|NCT00708071|141208409|SUPERIORITY_OR_OTHER|||||||0.625||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.625
70861044|NCT00708071|141208410|SUPERIORITY_OR_OTHER|||||||0.688||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.688
70861045|NCT00708071|141208411|SUPERIORITY_OR_OTHER|||||||1||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||1.000
70861046|NCT00708071|141208412|SUPERIORITY_OR_OTHER|||||||0.521||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.521
70861047|NCT00708071|141208413|SUPERIORITY_OR_OTHER|||||||0.324||90.0||||alpha = 10%|Two-sided Wilcoxon paired sample tests|||||||0.324
70861048|NCT00708071|141208414|SUPERIORITY_OR_OTHER|||||||0.661||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.661
70861049|NCT00708071|141208415|SUPERIORITY_OR_OTHER|||||||1||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||1.000
71133017|NCT01510158|141769247|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.26|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|0.17|0.36|||Cochran-Mantel-Haenszel|||||0.36|0.17|<0.0001
70861050|NCT00708071|141208416|SUPERIORITY_OR_OTHER|||||||0.699||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.699
70861051|NCT00708071|141208419|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||two-sided paired t-test|alpha = 5%||||||0.0010
70861052|NCT00708071|141208421|SUPERIORITY_OR_OTHER||Difference in proportions|0.182||||0.014|TWO_SIDED|95.0|0.04|0.34|||McNemar's test of paired proportions|Alpha = 5%|Difference in Proportions = (Number of SoC Participants with Hematoma/Seroma) - (Number of FS VH S/D 4 Participants with Hematoma/Seroma)|||0.34|0.04|0.014
70861053|NCT02140775|141208427|SUPERIORITY|||||||0.602|||||||Chi-squared|degrees of freedom = 1||A Chi-Square test was conducted between the treatment groups and the dichotomous outcome of successful achievement of employment goal.||||.602
70861054|NCT02140775|141208428|SUPERIORITY||Mean Difference (Final Values)|-3.74|STANDARD_ERROR_OF_MEAN|2.0||0.066|TWO_SIDED|95.0|-7.75|0.26|||t-test, 2 sided|||||0.26|-7.75|.066
70861055|NCT02140775|141208429|SUPERIORITY||Mean Difference (Final Values)|-3.25|STANDARD_ERROR_OF_MEAN|7.68||0.674|TWO_SIDED|95.0|-18.59|12.09|||t-test, 2 sided|||||12.09|-18.59|.674
70861056|NCT00945854|141208430|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANCOVA|||||||<0.05
70861057|NCT01659658|141208527|SUPERIORITY||Odds Ratio (OR)|1.1|||=|0.7623|TWO_SIDED|95.0|0.6|2.01||P-value was calculated from the unstratified Cochran-Mantel-Haenszel (CMH) test to compare hematologic response rate between the treatment arms.|Cochran-Mantel-Haenszel||Odds ratio was derived from a logistic regression model with treatment and 95% confidence interval (CI) for the odds ratio was based on the Wald approximation.|Statistical analysis was planned to be collected and analyzed in a combined manner for the non-ixazomib arm groups versus ixazomib group in this outcome measure.||2.01|0.60|=0.7623
70861058|NCT01659658|141208528|SUPERIORITY||Odds Ratio (OR)|0.75|||=|0.351|TWO_SIDED|95.0|0.41|1.38||P-value was calculated from the unstratified CMH test to make comparisons between the 2 treatment arms.|Cochran-Mantel-Haenszel||Odds ratio was derived from a logistic regression model with treatment and 95% CI for the odds ratio was based on the Wald approximation.|||1.38|0.41|=0.3510
70861059|NCT01659658|141208530|SUPERIORITY||Hazard Ratio (HR)|0.82|||=|0.389|TWO_SIDED|95.0|0.52|1.29||P-value was calculated using log-rank test stratified by the stratification factors.|Log Rank||||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|1.29|0.52|=0.389
70861060|NCT01659658|141208531|SUPERIORITY||Hazard Ratio (HR)|0.76|||=|0.135|TWO_SIDED|95.0|0.52|1.09||P-value was calculated using stratified log-rank test with stratification factors.|Log Rank||||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|1.09|0.52|=0.135
70861061|NCT01659658|141208532|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.2421|TWO_SIDED|95.0|0.48|1.21||P-value was calculated using log-rank test stratified by the stratification factors.|Log Rank||||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|1.21|0.48|0.2421
70861062|NCT01659658|141208533|SUPERIORITY||Hazard Ratio (HR)|0.62|||=|0.036|TWO_SIDED|95.0|0.39|0.97||P-value was calculated using log-rank test stratified by the stratification factors.|Log Rank||||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|0.97|0.39|=0.036
70861063|NCT01659658|141208534|SUPERIORITY||Odds Ratio (OR)|1.69|||=|0.226|TWO_SIDED|95.0|0.72|3.99||P-value was calculated from the unstratified CMH test to compare vital organ response rate between the 2 treatment arms.|Cochran-Mantel-Haenszel||Odds ratio was calculated from a logistic regression model with treatment and 95% CI for the odds ratio was based on the Wald approximation.|||3.99|0.72|=0.2260
71133018|NCT01510158|141769247|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.31|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|0.22|0.41|||Cochran-Mantel-Haenszel|||||0.41|0.22|<0.0001
71133019|NCT01510158|141769248|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99||||0.9796|TWO_SIDED|95.0|0.61|1.61|||Negative Binomial Regression|||||1.61|0.61|0.9796
71133020|NCT01510158|141769248|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88||||0.6125|TWO_SIDED|95.0|0.54|1.43|||Negative Binomial Regression|||||1.43|0.54|0.6125
70861064|NCT01659658|141208535|SUPERIORITY||Hazard Ratio (HR)|0.76|||=|0.163|TWO_SIDED|95.0|0.52|1.12||P-value was calculated using stratified log-rank test with stratification factors.|Log Rank||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|||1.12|0.52|=0.163
70861065|NCT01659658|141208538|SUPERIORITY||Hazard Ratio (HR)|0.68|||=|0.025|TWO_SIDED|95.0|0.49|0.96||P-value was calculated using stratified log-rank test with stratification factors.|Log Rank||||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|0.96|0.49|=0.025
70861066|NCT01659658|141208539|SUPERIORITY||Hazard Ratio (HR)|0.58|||=|0.01|TWO_SIDED|95.0|0.38|0.88||P-value was calculated using stratified log-rank test with stratification factors.|Log Rank||||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|0.88|0.38|=0.010
70861067|NCT03402659|141208548|OTHER||Mean Difference (Final Values)|-0.06098|STANDARD_ERROR_OF_MEAN|0.105548||0.564|TWO_SIDED|95.0|-0.26973|0.14777|||Mixed Models Analysis|||Mean change from baseline neflamapimod vs placebo||0.14777|-0.26973|0.564
70861068|NCT03402659|141208549|OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.72||0.823|TWO_SIDED|95.0|-6.0|4.8|||Mixed Models Analysis|||Mean change from baseline neflamapimod vs placebo||4.8|-6.0|0.823
70861069|NCT03402659|141208550|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.25||0.806|TWO_SIDED|95.0|-0.4|0.6|||Mixed Models Analysis|||Mean change from baseline neflamapimod vs placebo||0.6|-0.4|0.806
70861070|NCT03402659|141208551|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.39||0.489|TWO_SIDED|95.0|-1.0|0.5|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||0.5|-1.0|0.489
70861071|NCT03402659|141208552|OTHER||Mean Difference (Final Values)|-18.8|STANDARD_ERROR_OF_MEAN|8.6||0.031|TWO_SIDED|95.0|-35.8|-1.8|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||-1.8|-35.8|0.031
70947656|NCT02232399|141396091|OTHER|||||||0.45||||||To test whether there were any significant differences between the two treatment groups over time (group vs time interaction), a repeated measurement mixed-model approach was used. This assumed an unstructured covariance pattern.|Mixed Models Analysis|Unstructured covariance pattern was assumed.||To test whether there were any significant differences between the two treatment groups over time (group vs time interaction), a repeated measurement mixed-model approach was used. This assumed an unstructured covariance pattern.||||0.45
70861072|NCT03402659|141208553|OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.79||0.012|TWO_SIDED|95.0|-3.6|-0.5|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||-0.5|-3.6|0.012
70861073|NCT03402659|141208554|OTHER||Mean Difference (Final Values)|-117.4|STANDARD_ERROR_OF_MEAN|314.0||0.709|TWO_SIDED|95.0|-738.9|504.2|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||504.2|-738.9|0.709
70861074|NCT03402659|141208555|OTHER||Mean Difference (Final Values)|-21.0|STANDARD_ERROR_OF_MEAN|16.03||0.192|TWO_SIDED|95.0|-52.7|10.7|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||10.7|-52.7|0.192
70861075|NCT03402659|141208556|OTHER||Mean Difference (Final Values)|-21.0|STANDARD_ERROR_OF_MEAN|11.43||0.068|TWO_SIDED|95.0|-43.6|1.6|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||1.6|-43.6|0.068
70861076|NCT03402659|141208557|OTHER||Mean Difference (Final Values)|-110.1|STANDARD_ERROR_OF_MEAN|77.11||0.156|TWO_SIDED|95.0|-262.7|42.4|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||42.4|-262.7|0.156
70861077|NCT03402659|141208558|OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.59|TWO_SIDED|95.0|0.0|0.0|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||0.0|-0.0|0.590
70861078|NCT01442038|141208559|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.948||||0.48|TWO_SIDED|95.0|0.818|1.099||The p-value and hazard ratio are from Cox proportional hazards model stratifying by reason for qualifying percutaneous coronary intervention (PCI): acute coronary syndrome (ACS) versus non-ACS indication, and history of diabetes (yes versus no).|Cox Proportional Hazards Model|||||1.099|0.818|0.48
70861079|NCT01442038|141208560|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.665||||0.4|TWO_SIDED|95.0|0.244|1.691||The p-value and hazard ratio are from Cox proportional hazards model stratifying by reason for qualifying PCI: ACS versus non-ACS indication, and history of diabetes (yes versus no).|Cox Proportional Hazards Model|||||1.691|0.244|0.40
70861080|NCT01442038|141208561|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.073||||0.82|TWO_SIDED|95.0|0.579|1.994||The p-value and hazard ratio are from Cox proportional hazards model stratifying by reason for qualifying PCI: ACS versus non-ACS indication, and history of diabetes (yes versus no).|Cox Proportional Hazards Model|||||1.994|0.579|0.82
70861081|NCT01442038|141208562|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.968||||0.81|TWO_SIDED|95.0|0.745|1.256||The p-value and hazard ratio are from Cox proportional hazards model stratifying by reason for qualifying PCI: ACS versus non-ACS indication, and history of diabetes (yes versus no).|Cox Proportional Hazards Model|||||1.256|0.745|0.81
70861082|NCT03646643|141208570|SUPERIORITY||Hazard Ratio (HR)|0.12||||0.047|TWO_SIDED|95.0|0.02|0.97||A priori threshold \<0.05. Multiple comparisons adjustments: not needed.|Log Rank||The distal CS to LA connection elimination group had fewer recurrences (6.7%) compared with the standard group (46.7%), which translated to an 88% lower hazard of recurrence compared with the standard group.|Power calculation: assuming alpha 0.05, power 0.8, 1:1 randomization, and estimated relative risk of 14.4 for AF susceptibility with rate-dependent CS-LA conduction block, we anticipated a minimum sample size of 6 patients per group would be necessary to detect a difference using the log-rank test. Additional patients were recruited to account for potential losses to follow-up and a smaller detectable difference.||0.97|0.02|0.047
70861083|NCT00701376|141208630|SUPERIORITY||Mean Difference (Net)|-6.32||||0.03|TWO_SIDED|99.8|-15.6|2.94|||paired t-test|||||2.94|-15.6|0.03
70861084|NCT00701376|141208631|SUPERIORITY||Mean Difference (Net)|-7.56||||0.08|TWO_SIDED|99.8|-22.0|6.83|||Wilcoxon (Mann-Whitney)|||||6.83|-22.0|0.08
70861085|NCT00701376|141208632|SUPERIORITY||Mean Difference (Net)|5.84||||0.14|TWO_SIDED|99.8|-7.55|19.2|||paired t-test|||||19.2|-7.55|0.14
70861086|NCT00701376|141208634|SUPERIORITY||Mean Difference (Net)|-0.2|||<|0.001|TWO_SIDED|99.8|-0.38|-0.02|||paired t-test|||||-0.02|-0.38|<0.001
70947657|NCT02232399|141396092|OTHER|||||||0.7|||||||Regression, Logistic|||||||0.70
70947658|NCT01646385|141396099|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.836||||0.084|TWO_SIDED|95.0|0.683|1.025|||Regression, Cox|||Cox proportional hazards model adjusted for age, baseline steroid, smoking history, previous cancer, and body mass index was used for analysis.||1.025|0.683|0.084
70947659|NCT01646385|141396100|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.512||||0.035|TWO_SIDED|95.0|0.276|0.952|||Regression, Cox|||Cox proportional hazards model adjusted for age was used for analysis.||0.952|0.276|0.035
70947660|NCT01646385|141396101|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.019||||0.855|TWO_SIDED|95.0|0.831|1.251|||Regression, Cox|||Cox proportional hazards model adjusted for age, gender, previous non-RA drugs, baseline steroid, baseline DMARDs, methotrexate, disease activity score based on 28-joints count (DAS28), and smoking history was used for analysis.||1.251|0.831|0.855
71133021|NCT01510158|141769249|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.29||||0.0183|TWO_SIDED|95.0|-0.51|-0.08|||Cochran-Mantel-Haenszel|||||-0.08|-0.51|0.0183
70947661|NCT01646385|141396102|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.001|TWO_SIDED|95.0|0.564|0.87|||Regression, Cox|||Cox proportional hazards model adjusted for age, gender, previous non-RA drugs, baseline steroid, methotrexate, and baseline health assessment questionnaire (HAQ) score was used for analysis.||0.870|0.564|0.001
70947662|NCT01646385|141396103|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.717||||0.024|TWO_SIDED|95.0|0.537|0.958|||Regression, Cox|||Cox proportional hazards model adjusted for age, gender, previous non-RA drugs, baseline steroid, methotrexate, baseline HAQ score, Charlson index, smoking history, and body mass index was used for analysis.||0.958|0.537|0.024
71133022|NCT01510158|141769249|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.08||||0.5974|TWO_SIDED|95.0|-0.37|0.2|||Cochran-Mantel-Haenszel|||||0.2|-0.37|0.5974
71133023|NCT03078556|141769250|OTHER||Ratio|1.271|||||TWO_SIDED|90.0|1.1894|1.3582|||||Ratio (B/A) of plasma DTG has been presented.|||1.3582|1.1894|
71133024|NCT03078556|141769250|OTHER||Ratio|1.0341|||||TWO_SIDED|90.0|1.0097|1.0591|||||Ratio (B/A) of plasma 3TC has been presented.|||1.0591|1.0097|
71133025|NCT03078556|141769251|OTHER||Ratio|1.155|||||TWO_SIDED|90.0|1.0699|1.2468|||||Ratio (C/A) of plasma DTG has been presented.|||1.2468|1.0699|
71133026|NCT03078556|141769251|OTHER||Ratio|1.0635|||||TWO_SIDED|90.0|1.0413|1.0861|||||Ratio (C/A) of plasma 3TC has been presented.|||1.0861|1.0413|
71133027|NCT03078556|141769252|OTHER||Ratio|1.2756|||||TWO_SIDED|90.0|1.1919|1.3651|||||Ratio (B/A) of plasma DTG has been presented.|||1.3651|1.1919|
71133028|NCT03078556|141769252|OTHER||Ratio|1.0372|||||TWO_SIDED|90.0|1.0116|1.0634|||||Ratio (B/A) of plasma 3TC has been presented.|||1.0634|1.0116|
71133029|NCT03078556|141769253|OTHER||Ratio|1.1578|||||TWO_SIDED|90.0|1.0718|1.2507|||||Ratio (C/A) of plasma DTG has been presented.|||1.2507|1.0718|
71133030|NCT03078556|141769253|OTHER||Ratio|1.0702|||||TWO_SIDED|90.0|1.0464|1.0946|||||Ratio (C/A) of plasma 3TC has been presented.|||1.0946|1.0464|
71133031|NCT03078556|141769254|OTHER||Ratio|1.2805|||||TWO_SIDED|90.0|1.189|1.379|||||Ratio (B/A) of plasma DTG has been presented.|||1.3790|1.1890|
71133032|NCT03078556|141769254|OTHER||Ratio|1.1956|||||TWO_SIDED|90.0|1.1437|1.2498|||||Ratio (B/A) of plasma 3TC has been presented.|||1.2498|1.1437|
71133033|NCT03078556|141769255|OTHER||Ratio|1.141|||||TWO_SIDED|90.0|1.0533|1.2361|||||Ratio (C/A) of plasma DTG has been presented.|||1.2361|1.0533|
71133034|NCT03078556|141769255|OTHER||Ratio|1.3176|||||TWO_SIDED|90.0|1.2616|1.376|||||Ratio (C/A) of plasma 3TC has been presented.|||1.3760|1.2616|
71133035|NCT03078556|141769256|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0|||||Median Difference of plasma DTG has been presented.|||0.000|0.000|
71133036|NCT03078556|141769256|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0|||||Median Difference of plasma 3TC has been presented.|||0.000|0.000|
71133037|NCT03078556|141769257|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|-0.004|0.0|||||Median Difference of plasma DTG has been presented.|||0.000|-0.004|
71133038|NCT03078556|141769257|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0|||||Median Difference of plasma 3TC has been presented.|||0.000|0.000|
71133039|NCT03078556|141769258|OTHER||Median Difference (Final Values)|-0.127|||||TWO_SIDED|90.0|-0.5|0.248|||||Median Difference of plasma DTG has been presented.|||0.248|-0.500|
71133040|NCT03078556|141769258|OTHER||Median Difference (Final Values)|-0.126|||||TWO_SIDED|90.0|-0.253|-0.001|||||Median Difference of plasma 3TC has been presented.|||-0.001|-0.253|
71133041|NCT03078556|141769259|OTHER||Median Difference (Final Values)|-0.127|||||TWO_SIDED|90.0|-0.497|0.132|||||Median Difference of plasma DTG has been presented.|||0.132|-0.497|
71133042|NCT03078556|141769259|OTHER||Median Difference (Final Values)|-0.248|||||TWO_SIDED|90.0|-0.376|-0.001|||||Median Difference of plasma 3TC has been presented.|||-0.001|-0.376|
71133043|NCT03078556|141769268|OTHER||Ratio|1.2774|||||TWO_SIDED|90.0|1.1931|1.3676|||||Ratio (B/A) of plasma DTG has been presented.|||1.3676|1.1931|
71133044|NCT03078556|141769268|OTHER||Ratio|1.0475|||||TWO_SIDED|90.0|1.0185|1.0773|||||Ratio (B/A) of plasma 3TC has been presented.|||1.0773|1.0185|
71133045|NCT03078556|141769269|OTHER||Ratio|1.1599|||||TWO_SIDED|90.0|1.0711|1.256|||||Ratio (C/A) of plasma DTG has been presented.|||1.2560|1.0711|
71133046|NCT03078556|141769269|OTHER||Ratio|1.0807|||||TWO_SIDED|90.0|1.0539|1.1081|||||Ratio (C/A) of plasma 3TC has been presented.|||1.1081|1.0539|
71133047|NCT03078556|141769270|OTHER||Ratio|0.7868|||||TWO_SIDED|90.0|0.7363|0.8408|||||Ratio (B/A) of plasma DTG has been presented.|||0.8408|0.7363|
71133048|NCT03078556|141769270|OTHER||Ratio|0.967|||||TWO_SIDED|90.0|0.9442|0.9904|||||Ratio (B/A) of plasma 3TC has been presented.|||0.9904|0.9442|
71133049|NCT03078556|141769271|OTHER||Ratio|0.8658|||||TWO_SIDED|90.0|0.8021|0.9347|||||Ratio (C/A) of plasma DTG has been presented.|||0.9347|0.8021|
71133050|NCT03078556|141769271|OTHER||Ratio|0.9403|||||TWO_SIDED|90.0|0.9207|0.9604|||||Ratio (C/A) of plasma 3TC has been presented.|||0.9604|0.9207|
71133051|NCT03078556|141769272|OTHER||Ratio|0.7859|||||TWO_SIDED|90.0|0.7318|0.844|||||Ratio (B/A) of plasma DTG has been presented.|||0.8440|0.7318|
71133052|NCT03078556|141769272|OTHER||Ratio|0.9704|||||TWO_SIDED|90.0|0.9157|1.0284|||||Ratio (B/A) of plasma 3TC has been presented.|||1.0284|0.9157|
71133053|NCT03078556|141769273|OTHER||Ratio|0.8571|||||TWO_SIDED|90.0|0.7914|0.9282|||||Ratio (C/A) of plasma DTG has been presented.|||0.9282|0.7914|
71133054|NCT03078556|141769273|OTHER||Ratio|0.9153|||||TWO_SIDED|90.0|0.8613|0.9728|||||Ratio (C/A) of plasma 3TC has been presented.|||0.9728|0.8613|
71133055|NCT03078556|141769274|OTHER||Ratio|1.2632|||||TWO_SIDED|90.0|1.1811|1.3511|||||Ratio (B/A) of plasma DTG has been presented.|||1.3511|1.1811|
71133056|NCT03078556|141769274|OTHER||Ratio|0.9598|||||TWO_SIDED|90.0|0.9268|0.9941|||||Ratio (B/A) of plasma 3TC has been presented.|||0.9941|0.9268|
71133057|NCT03078556|141769275|OTHER||Ratio|1.1425|||||TWO_SIDED|90.0|1.0597|1.2317|||||Ratio (C/A) of plasma DTG has been presented.|||1.2317|1.0597|
71133058|NCT03078556|141769275|OTHER||Ratio|0.9548|||||TWO_SIDED|90.0|0.9299|0.9804|||||Ratio (C/A) of plasma 3TC has been presented.|||0.9804|0.9299|
71133059|NCT03078556|141769276|OTHER||Ratio|1.1839|||||TWO_SIDED|90.0|1.0921|1.2834|||||Ratio (B/A) of plasma DTG has been presented|||1.2834|1.0921|
70947663|NCT01646385|141396106|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
70947664|NCT01646385|141396107|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Change at Year 1: analysis was performed with Analysis of Covariance (ANCOVA) using the General Linear Model (GLM) method applying age, gender, baseline DAS28, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.0001
71133060|NCT03078556|141769276|OTHER||Ratio|0.8874|||||TWO_SIDED|90.0|0.834|0.9443|||||Ratio (B/A) of plasma 3TC has been presented|||0.9443|0.8340|
71133061|NCT03078556|141769277|OTHER||Ratio|1.078|||||TWO_SIDED|90.0|0.9958|1.167|||||Ratio (B/A) of plasma DTG has been presented|||1.1670|0.9958|
71133062|NCT03078556|141769277|OTHER||Ratio|0.9049|||||TWO_SIDED|90.0|0.8474|0.9663|||||Ratio (B/A) of plasma 3TC has been presented|||0.9663|0.8474|
71133063|NCT03078556|141769278|OTHER||Ratio|1.1545|||||TWO_SIDED|90.0|1.0208|1.3058|||||Ratio (Bfed/B) of plasma DTG has been presented|||1.3058|1.0208|
71133064|NCT03078556|141769278|OTHER||Ratio|0.9577|||||TWO_SIDED|90.0|0.9126|1.0049|||||Ratio (Bfed/B) of plasma 3TC has been presented|||1.0049|0.9126|
71133065|NCT03078556|141769279|OTHER||Ratio|1.3256|||||TWO_SIDED|90.0|1.1837|1.4845|||||Ratio (Cfed/C) of plasma DTG has been presented|||1.4845|1.1837|
71133066|NCT03078556|141769279|OTHER||Ratio|0.9114|||||TWO_SIDED|90.0|0.8658|0.9593|||||Ratio (Cfed/C) of plasma 3TC has been presented|||0.9593|0.8658|
71133067|NCT03078556|141769280|OTHER||Ratio|1.1481|||||TWO_SIDED|90.0|1.0154|1.2982|||||Ratio (Bfed/B) of plasma DTG has been presented|||1.2982|1.0154|
71133068|NCT03078556|141769280|OTHER||Ratio|0.9524|||||TWO_SIDED|90.0|0.9086|0.9983|||||Ratio (Bfed/B) of plasma 3TC has been presented|||0.9983|0.9086|
71133069|NCT03078556|141769281|OTHER||Ratio|1.3176|||||TWO_SIDED|90.0|1.175|1.4775|||||Ratio (Cfed/C) of plasma DTG has been presented|||1.4775|1.1750|
71133070|NCT03078556|141769281|OTHER||Ratio|0.9048|||||TWO_SIDED|90.0|0.8592|0.9528|||||Ratio (Cfed/C) of plasma 3TC has been presented|||0.9528|0.8592|
71133071|NCT03078556|141769282|OTHER||Ratio|1.0808|||||TWO_SIDED|90.0|0.9527|1.2261|||||Ratio (Bfed/B) of plasma DTG has been presented|||1.2261|0.9527|
71133072|NCT03078556|141769282|OTHER||Ratio|0.7097|||||TWO_SIDED|90.0|0.6474|0.7779|||||Ratio (Bfed/B) of plasma 3TC has been presented|||0.7779|0.6474|
71133073|NCT03078556|141769283|OTHER||Ratio|1.2096|||||TWO_SIDED|90.0|1.0521|1.3908|||||Ratio (Cfed/C) of plasma DTG has been presented|||1.3908|1.0521|
71133074|NCT03078556|141769283|OTHER||Ratio|0.6826|||||TWO_SIDED|90.0|0.5861|0.795|||||Ratio (Cfed/C) of plasma 3TC has been presented|||0.7950|0.5861|
71133075|NCT03078556|141769284|OTHER||Median Difference (Final Values)|0.254|||||TWO_SIDED|90.0|0.25|0.378|||||Median Difference of plasma DTG has been presented|||0.378|0.250|
71133076|NCT03078556|141769284|OTHER||Median Difference (Final Values)|0.125|||||TWO_SIDED|90.0|0.0|0.127|||||Median Difference of plasma 3TC has been presented|||0.127|0.000|
71133077|NCT03078556|141769285|OTHER||Median Difference (Final Values)|0.126|||||TWO_SIDED|90.0|0.0|0.25|||||Median Difference of plasma DTG has been presented|||0.250|0.000|
71133078|NCT03078556|141769285|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.125|||||Median Difference of plasma 3TC has been presented|||0.125|0.000|
71133079|NCT03078556|141769286|OTHER||Median Difference (Final Values)|3.017|||||TWO_SIDED|90.0|1.872|4.496|||||Median Difference of plasma DTG has been presented|||4.496|1.872|
71133080|NCT03078556|141769286|OTHER||Median Difference (Final Values)|2.113|||||TWO_SIDED|90.0|1.5|2.751|||||Median Difference of plasma 3TC has been presented|||2.751|1.500|
71133081|NCT03078556|141769287|OTHER||Median Difference (Final Values)|2.5|||||TWO_SIDED|90.0|1.748|3.751|||||Median Difference of plasma DTG has been presented|||3.751|1.748|
71133082|NCT03078556|141769287|OTHER||Median Difference (Final Values)|1.503|||||TWO_SIDED|90.0|0.998|2.252|||||Median Difference of plasma 3TC has been presented|||2.252|0.998|
71133083|NCT03078556|141769296|OTHER||Ratio|1.0849|||||TWO_SIDED|90.0|0.9613|1.2245|||||Ratio (Bfed/B) of plasma DTG has been presented|||1.2245|0.9613|
71133084|NCT03078556|141769296|OTHER||Ratio|0.9363|||||TWO_SIDED|90.0|0.8913|0.9836|||||Ratio (Bfed/B) of plasma 3TC has been presented|||0.9836|0.8913|
71133085|NCT03078556|141769297|OTHER||Median Difference (Final Values)|1.2477|||||TWO_SIDED|90.0|1.1013|1.4136|||||Median Difference of plasma DTG has been presented|||1.4136|1.1013|
71133086|NCT03078556|141769297|OTHER||Median Difference (Final Values)|0.8836|||||TWO_SIDED|90.0|0.8351|0.935|||||Median Difference of plasma 3TC has been presented|||0.9350|0.8351|
71133087|NCT03078556|141769298|OTHER||Ratio|0.8661|||||TWO_SIDED|90.0|0.7658|0.9796|||||Ratio (Bfed/B) of plasma DTG has been presented|||0.9796|0.7658|
71133088|NCT03078556|141769298|OTHER||Ratio|1.0442|||||TWO_SIDED|90.0|0.9951|1.0957|||||Ratio (Bfed/B) of plasma 3TC has been presented|||1.0957|0.9951|
71133089|NCT03078556|141769299|OTHER||Ratio|0.7544|||||TWO_SIDED|90.0|0.6736|0.8448|||||Ratio (Cfed/C) of plasma DTG has been presented|||0.8448|0.6736|
71133090|NCT03078556|141769299|OTHER||Ratio|1.0972|||||TWO_SIDED|90.0|1.0424|1.155|||||Ratio (Cfed/C) of plasma 3TC has been presented|||1.1550|1.0424|
71133091|NCT03078556|141769302|OTHER||Ratio|0.8654|||||TWO_SIDED|90.0|0.7629|0.9816|||||Ratio (Bfed/B) of plasma DTG has been presented|||0.9816|0.7629|
71133092|NCT03078556|141769302|OTHER||Ratio|1.0841|||||TWO_SIDED|90.0|0.9139|1.286|||||Ratio (Bfed/B) of plasma 3TC has been presented|||1.2860|0.9139|
71133093|NCT03078556|141769303|OTHER||Ratio|0.7657|||||TWO_SIDED|90.0|0.6702|0.8749|||||Ratio (Cfed/C) of plasma DTG has been presented|||0.8749|0.6702|
71133094|NCT03078556|141769303|OTHER||Ratio|1.197|||||TWO_SIDED|90.0|1.0869|1.3182|||||Ratio (Cfed/C) of plasma 3TC has been presented|||1.3182|1.0869|
71133095|NCT03078556|141769304|OTHER||Ratio|1.2929|||||TWO_SIDED|90.0|1.1281|1.4819|||||Ratio (Bfed/B) of plasma DTG has been presented|||1.4819|1.1281|
71133096|NCT03078556|141769304|OTHER||Ratio|1.2015|||||TWO_SIDED|90.0|1.1074|1.3036|||||Ratio (Bfed/B) of plasma 3TC has been presented|||1.3036|1.1074|
71133097|NCT03078556|141769305|OTHER||Ratio|1.469|||||TWO_SIDED|90.0|1.3009|1.6588|||||Ratio (Cfed/C) of plasma DTG has been presented|||1.6588|1.3009|
71133098|NCT03078556|141769305|OTHER||Ratio|1.1935|||||TWO_SIDED|90.0|1.1142|1.2785|||||Ratio (Cfed/C) of plasma 3TC has been presented|||1.2785|1.1142|
71133099|NCT01915173|141769339|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Regression, Logistic|||All 4 arms were combined to compare the Standard Interview groups to the Expanded Interview groups. We calculated that we had 45-74% power to detect a 30-40% difference in responders between groups in the pre-specified primary outcome measure, the percent of subjects with a 50% or greater improvement in GERD symptom severity.||||0.01
71133100|NCT01915173|141769339|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED||||||Regression, Logistic|||All 4 arms were combined to compare the Placebo groups to the Supplement groups. We calculated that we had 45-74% power to detect a 30-40% difference in responders between groups in the pre-specified primary outcome measure, the percent of subjects with a 50% or greater improvement in GERD symptom severity.||||0.33
71133101|NCT02152761|141769341|SUPERIORITY||Treatment Group Ratio (BYM - Placebo)|1.057|||<|0.0001|TWO_SIDED|95.0|1.037|1.076|||Mixed Models Analysis||Holm-Bonferroni method: Used to adjust the Type I error for two comparisons (BYM338 700 mg/Placebo) at Week 24. No control for multiplicity was made at Week 12.|week 12||1.076|1.037|<.0001
71133102|NCT02152761|141769341|SUPERIORITY||Treatment group rratio (BYM - Placebo)|1.043|||<|0.0001|TWO_SIDED|95.0|1.024|1.064|||Mixed Models Analysis||Holm-Bonferroni method: Used to adjust the Type I error for two comparisons (BYM338 700 mg/Placebo) at Week 24. No control for multiplicity was made at Week 12.|week 12||1.064|1.024|<.0001
71133103|NCT02152761|141769342|SUPERIORITY||LS Mean of Treatment Difference|-0.071||||0.1829|TWO_SIDED|95.0|-0.175|0.034||Treatment Difference (BYM-Placebo)|Mixed Models Analysis|||week 24||0.034|-0.175|0.1829
71133104|NCT02152761|141769342|SUPERIORITY||LS Mean of Treatment Difference|0.011||||0.8365|TWO_SIDED|95.0|-0.096|0.119|||Mixed Models Analysis|||week 24||0.119|-0.096|0.8365
71133105|NCT02152761|141769343|SUPERIORITY||LS Mean of Treatment Difference|-0.371||||0.5802|TWO_SIDED|95.0|-1.311|1.053|||Mixed Models Analysis|||week 24||1.053|-1.311|0.5802
71133106|NCT02152761|141769343|SUPERIORITY||LS Mean of the Treatment Difference|0.833||||0.0913|TWO_SIDED|95.0|-0.135|1.801|||Mixed Models Analysis|||week 24||1.801|-0.135|0.0913
71133107|NCT02152761|141769344|SUPERIORITY||Falls Rate Ratio|1.08||||0.8353|TWO_SIDED|95.0|0.53|2.21|||Negative binomial regression|||||2.21|0.53|0.8353
71133108|NCT02152761|141769344|SUPERIORITY||Falls Rate Ratio|1.58||||0.2015|TWO_SIDED|95.0|0.78|3.18|||Negative binomial regression|||||3.18|0.78|0.2015
71133109|NCT02152761|141769344|SUPERIORITY||Falls Rate Ratio|1.25||||0.3999|TWO_SIDED|95.0|0.52|3.0|||Negative binomial regression|||week 24||3.00|0.52|0.3999
71133110|NCT02631551|141769364|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||GSP 301 NS vs GSP 301 placebo NS comparison for rTNSS was tested at 0.05 significance level.||||<0.0001
71133111|NCT02631551|141769364|SUPERIORITY|||||||0.0029|||||||Mixed Models Analysis|||GSP 301 NS vs Olopatadine HCl NS comparison for rTNSS was tested at 0.05 significance level.||||0.0029
70861087|NCT00701376|141208635|SUPERIORITY||Mean Difference (Net)|-0.23||||0.1|TWO_SIDED|99.8|-0.68|0.23|||paired t-test|||||0.23|-0.68|0.10
70861088|NCT00701376|141208636|SUPERIORITY||Mean Difference (Net)|-1.72||||0.21|TWO_SIDED|99.8|-8.68|5.25|||paired t-test|||||5.25|-8.68|0.21
71133112|NCT02631551|141769364|SUPERIORITY|||||||0.0587|||||||Mixed Models Analysis|||GSP 301 NS vs Mometasone furoate NS comparison for rTNSS was tested at 0.05 significance level.||||0.0587
71133113|NCT02631551|141769364|SUPERIORITY|||||||0.0755|||||||Mixed Models Analysis|||Olopatadine HCl NS vs GSP 301 Placebo NS comparison for rTNSS was tested at 0.05 significance level.||||0.0755
71133114|NCT02631551|141769364|SUPERIORITY|||||||0.0043|||||||Mixed Models Analysis|||Mometasone furoate NS vs GSP 301 Placebo NS comparison for rTNSS was tested at 0.05 significance level.||||0.0043
71133115|NCT01318408|141769370|NON_INFERIORITY_OR_EQUIVALENCE|Assessing effects on cognition over time.||||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The intent-to-treat group included all individuals who initiated levetiracetam. The Mann-Whitney U test was used to determine changes in participants' scores for cognition, function, and behavior between baseline and 12 weeks.Change in MMSE test scores was the primary outcome measure.||||.01
71133116|NCT01318408|141769371|NON_INFERIORITY_OR_EQUIVALENCE|Assessing cognitive effects over time.||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Lower scores (negative change) indicate improvements on the ADAS-cog.||||||.02
71133117|NCT00377858|141769383|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin of 0.3% based on prior studies indicating an HbA1c difference of 0.6% in patients treated with lispro and sulfonylurea compared with those treated with sulfonylurea and metformin.|Mean Difference (Net)|0.17||||0.097||95.0|-0.03|0.37|||ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c Stratum + Sulfonylurea stratum + Country + Baseline HbA1c Stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for (Insulin Lispro Mid Mixture minus Insulin Glargine).|Assuming 15% drop-out rate after randomization, remaining 213 patients in each treatment group would allow confirmation of noninferiority with no treatment difference and a noninferiority limit of 0.3% using upper limit of 2-sided confidence interval at significance level of 0.05 with 80% power.||0.37|-0.03|0.097
71133118|NCT00377858|141769384|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.047||95.0|0.0|0.33||P-value for 12 Week Interval.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.33|0.00|0.047
71133119|NCT00377858|141769384|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18||||0.043||95.0|0.01|0.35||P-value for 24 Week Interval.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.35|0.01|0.043
70861089|NCT00701376|141208638|SUPERIORITY|||||||0.002|||||||Wilcoxon signed-rank test|||||||0.002
70861090|NCT00701376|141208639|SUPERIORITY|||||||0.04|||||||Wilcoxon signed-rank test|||||||0.04
70861091|NCT00701376|141208640|SUPERIORITY|||||||0.005|||||||Wilcoxon signed-rank test|||||||0.005
70861092|NCT00701376|141208641|SUPERIORITY|||||||0.001|||||||Wilcoxon signed-rank test|||||||0.001
70861093|NCT03595774|141208662|SUPERIORITY|||||||0.0833||||||a priori threshold for statistical significance of P\<0.05|ANOVA|One-way ANOVA for repeated measures followed by Holm-Šídák's multiple comparisons test||||||0.0833
70947665|NCT01646385|141396107|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Change at Year 2: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline DAS28, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.0001
70947666|NCT01646385|141396107|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Change at Year 3: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline DAS28, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.0001
70947667|NCT01646385|141396107|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Change at Year 4: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline DAS28, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.0001
70947668|NCT01646385|141396107|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANCOVA|||Change at Year 5: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline DAS28, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||0.01
71133120|NCT00377858|141769384|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.343||95.0|-0.1|0.29||P-value for 36 Week Interval.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.29|-0.10|0.343
71133121|NCT00377858|141769385|SUPERIORITY_OR_OTHER|||||||0.432||95.0||||P-value for Week 12: HbA1c ≤7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.432
71133122|NCT00377858|141769385|SUPERIORITY_OR_OTHER|||||||0.602||95.0||||P-value for 12 Week: HbA1c \<7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.602
71133123|NCT00377858|141769385|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||P-value for 12 Week: HbA1c ≤6.5%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.370
71133124|NCT00377858|141769385|SUPERIORITY_OR_OTHER|||||||0.198||95.0||||P-value for 24 Week: HbA1c ≤7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.198
71133125|NCT00377858|141769385|SUPERIORITY_OR_OTHER|||||||0.636||95.0||||P-value for 24 Week: HbA1c \<7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.636
71133126|NCT00377858|141769385|SUPERIORITY_OR_OTHER|||||||0.185||95.0||||P-value for 24 Week: HbA1c ≤6.5%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.185
71133127|NCT00377858|141769385|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||P-value for 36 Week: HbA1c ≤7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.393
71133128|NCT00377858|141769385|SUPERIORITY_OR_OTHER|||||||0.739||95.0||||P-value for 36 Week: HbA1c \<7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.739
70861094|NCT03595774|141208663|SUPERIORITY|||||||0.0131||||||a priori threshold for statistical significance of P\<0.05|ANOVA|One-way ANOVA for repeated measures followed by Holm-Šídák's multiple comparisons test||||||0.0131
70947669|NCT01646385|141396110|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
70947670|NCT01646385|141396111|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Change at Year 1: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline HAQ, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.001
70947671|NCT01646385|141396111|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Change at Year 2: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline HAQ, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.001
70947672|NCT01646385|141396111|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Change at Year 3: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline HAQ, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.001
71133129|NCT00377858|141769385|SUPERIORITY_OR_OTHER|||||||0.396||95.0||||P-value for 36 Week: HbA1c ≤6.5%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.396
71133130|NCT00377858|141769385|SUPERIORITY_OR_OTHER|||||||0.227||95.0||||P-value for Endpoint (LOCF): HbA1c ≤7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.227
71133131|NCT00377858|141769385|SUPERIORITY_OR_OTHER|||||||0.482||95.0||||P-value for Endpoint (LOCF): HbA1c \<7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.482
71133132|NCT00377858|141769385|SUPERIORITY_OR_OTHER|||||||0.108||95.0||||P-value for Endpoint (LOCF): HbA1c ≤6.5%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.108
71133133|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58||||0.014||95.0|0.12|1.04||P-value for Baseline: Morning Pre-Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||1.04|0.12|0.014
71133134|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.735||95.0|-0.51|0.72||P-value for Baseline: Morning Postprandial Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.72|-0.51|0.735
71133135|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.54||||0.051||95.0|0.0|1.08||P-value for Baseline: Midday Pre-Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||1.08|-0.00|0.051
70861095|NCT03595774|141208664|SUPERIORITY|||||||0.012728||||||a prior threshold for significant of P\<0.05|ANOVA|Two-way ANOVA for repeated measured followed by Holm-Šídák's multiple comparisons test||||||0.012728
70861096|NCT03595774|141208665|SUPERIORITY|||||||2e-08||||||a priori threshold for statistical significance of P\<0.05|ANOVA|Two-way ANOVA for repeated measures followed by Holm-Šídák's multiple comparisons test||||||0.00000002
70861097|NCT03595774|141208666|SUPERIORITY|||||||0.017215||||||a priori threshold for statistical significance of P\<0.05|ANOVA|Two-way ANOVA for repeated measures followed by Holm-Šídák's multiple comparisons test||||||0.017215
70861098|NCT01593722|141208670|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.68
70861099|NCT02788474|141208689|OTHER||Adjusted mean difference|-0.00066|STANDARD_ERROR_OF_MEAN|0.00282||0.8146|TWO_SIDED|95.0|-0.00621|0.00488||random coefficient regression (random slopes and intercepts) model including sex, age and height as covariates (Due to the low number of measurements per patient, baseline CRPM was included as a response rather than as a covariate in the analysis)|random coefficient regression|The Kenward-Roger approximation was used to estimate denominators degrees of freedom.|Difference calculated as Nintedanib minus Placebo|"The rate of change (slope) in blood CRPM was assumed to be linear in each subject over the 12 weeks of treatment. The intercepts and slopes were assumed to be normally distributed with arbitrary covariance matrix.~Since the distribution of the data was not normal, a log10 transformation was performed before conducting the statistical analyses.~Significance tests were based on least-square means using 2-sided 95% confidence intervals (2-sided α=0.05)."||0.00488|-0.00621|0.8146
70861100|NCT02788474|141208690|OTHER||slope estimate|22.001||||0.2084|TWO_SIDED|95.0|-11.83|57.58|||Regression, Logistic||Slope estimate is the monthly rate of change in CRPM up to week 12|To assess the association between disease progression (as defined by absolute forced vital capacity (FVC) decline \>=10% or death) and the change in the Extracellular matrix (ECM) biomarker CRPM in the first 12 weeks, a logistic regression analysis including baseline blood CRPM and the monthly rate of change (slope) in blood CRPM in the first 12 weeks as covariates was applied for placebo-treated patients only to evaluate the potential of CRPM as a prognostic biomarker.||57.58|-11.83|0.2084
70861101|NCT02788474|141208690|OTHER||slope estimate|-45.566||||0.1537|TWO_SIDED|95.0|-109.55|16.37|||Regression, Logistic||Slope estimate is the monthly rate of change in CRPM up to week 12|To assess how nintedanib treatment affected the association between disease progression (as defined by absolute forced vital capacity (FVC) decline \>=10% or death) and the change in CRPM in the first 12 weeks, a logistic regression analysis including baseline blood CRPM, the monthly rate of change (slope) in blood CRPM up to Week 12, treatment and treatment-CRPM slope interaction as covariates was applied.||16.37|-109.55|0.1537
70861102|NCT02788474|141208690|OTHER||Odds Ratio (OR)|0.769||||0.3116|TWO_SIDED|95.0|0.46|1.27|||Regression, Logistic|||To assess whether the overall treatment regimen affected disease progression (as defined by absolute forced vital capacity (FVC) decline \>=10% or death), a logistic regression analysis including baseline blood CRPM and randomised treatment as covariates was applied.||1.27|0.46|0.3116
70861103|NCT02788474|141208690|OTHER||Odds Ratio (OR)|0.772||||0.3175|TWO_SIDED|95.0|0.46|1.27|||Regression, Logistic|||To assess whether the monthly rate of change (slope) in blood CRPM in the first 12 weeks could explain the effect of treatment on disease progression (as defined by absolute forced vital capacity (FVC) decline \>=10% or death), a logistic regression analysis including baseline blood CRPM, the rate of change (slope) in blood CRPM in the first 12 weeks and randomised treatment as covariates was applied.||1.27|0.46|0.3175
71133136|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18||||0.536||95.0|-0.39|0.75||P-value for Baseline: Midday Postprandial Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.75|-0.39|0.536
70861104|NCT02788474|141208691|OTHER||Adjusted mean difference|0.00121|STANDARD_ERROR_OF_MEAN|0.002||0.5469|TWO_SIDED|95.0|-0.00273|0.00515||random coefficient regression model (C1M (negative reciprocal root-transformed)) with fixed effects for gender, age, height and random effect of patient specific intercept and time.|random coefficient regression||Difference calculated as Nintedanib minus Placebo. Inter-individual variability is modelled by a Variance-Components variance-covariance matrix.|"The rate of change (slope) in blood C1M was assumed to be linear in each subject over the 12 weeks of treatment.~Within-patient errors are modelled by an Unstructured variance-covariance matrix."||0.00515|-0.00273|0.5469
70861105|NCT02788474|141208692|OTHER||Adjusted mean difference|-0.00307|STANDARD_ERROR_OF_MEAN|0.00262||0.2429|TWO_SIDED|95.0|-0.00823|0.00209||random coefficient regression model (C3M (log10-transformed)) with fixed effects for gender, age, height and random effect of patient specific intercept and time.|random coefficient regression||Difference calculated as Nintedanib minus Placebo. Inter-individual variability is modelled by a Variance-Components variance-covariance matrix.|"The rate of change (slope) in blood C3M was assumed to be linear in each subject over the 12 weeks of treatment.~Within-patient errors are modelled by an Unstructured variance-covariance matrix."||0.00209|-0.00823|0.2429
70861106|NCT01272284|141208693|SUPERIORITY_OR_OTHER_LEGACY||Proportion successful|85.4|||<|0.0001|ONE_SIDED|95.81|78.1||||Fisher Exact|||The final significance level is 0.04191 accounting for one interim analysis conducted at 80% of final information, thus a 95.81% Confidence Limit (CL) was used.|||78.1|<0.0001
70861107|NCT02869438|141208735|SUPERIORITY||Mean Difference (Final Values)|0.077||||0.0707|TWO_SIDED|95.0|-0.007|0.161|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 28|||0.161|-0.007|0.0707
70861108|NCT02869438|141208735|SUPERIORITY||Mean Difference (Final Values)|0.013||||0.7747|TWO_SIDED|95.0|-0.077|0.104|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 56|||0.104|-0.077|0.7747
70861109|NCT02869438|141208735|SUPERIORITY||Mean Difference (Final Values)|0.079||||0.0969|TWO_SIDED|95.0|-0.014|0.173|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 84|||0.173|-0.014|0.0969
71133137|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.793||95.0|-0.48|0.62||P-value for Baseline: Evening Pre-Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.62|-0.48|0.793
70947673|NCT04294667|141396125|SUPERIORITY|The difference in proportion responding between SOC+DZP 24mg/kg and SOC+PBO was estimated and tested using the Cochran-Mantel-Haenszel (CMH) risk difference estimate controlling for the randomization stratification factors, Pooled Region (North America vs Western Europe/Asia-Pacific vs Latin America/Eastern Europe), Screening disease activity (chronic active vs acute flaring) and Screening SLEDAI score (\<10 vs \>=10).|Difference in Proportions (%)|14.6||||0.011|TWO_SIDED|95.0|3.3|25.8|||Cochran-Mantel-Haenszel|||||25.8|3.3|0.0110
70947674|NCT04294667|141396126|SUPERIORITY|The difference in proportion responding between SOC+DZP 24mg/kg and SOC+PBO was estimated and tested using the CMH risk difference estimate controlling for the randomization stratification factors, Pooled Region (North America vs Western Europe/Asia-Pacific vs Latin America/Eastern Europe), Screening disease activity (chronic active vs acute flaring) and Screening SLEDAI score (\<10 vs \>=10).|Difference in Proportions (%)|7.9||||0.1776|TWO_SIDED|95.0|-3.6|19.4|||Cochran-Mantel-Haenszel|||||19.4|-3.6|0.1776
70947675|NCT04294667|141396127|SUPERIORITY|The difference in proportion responding between SOC+DZP 24mg/kg and SOC+PBO was estimated and tested using the CMH risk difference estimate controlling for the randomization stratification factors, Pooled Region (North America vs Western Europe/Asia-Pacific vs Latin America/Eastern Europe), Screening disease activity (chronic active vs acute flaring) and Screening SLEDAI score (\<10 vs \>=10).|Difference in Proportions (%)|10.8||||0.0518|TWO_SIDED|95.0|-0.1|21.7|||Cochran-Mantel-Haenszel|||||21.7|-0.1|0.0518
70947676|NCT04294667|141396128|SUPERIORITY|The difference in proportion responding between SOC+DZP 24mg/kg and SOC+PBO was estimated and tested using the CMH risk difference estimate controlling for the randomization stratification factors, Pooled Region (North America vs Western Europe/Asia-Pacific vs Latin America/Eastern Europe), Screening disease activity (chronic active vs acute flaring) and Screening SLEDAI score (\<10 vs \>=10).|Difference in Proportions (%)|11.5||||0.0257|TWO_SIDED|95.0|1.4|21.6|||Cochran-Mantel-Haenszel|||||21.6|1.4|0.0257
70947677|NCT04294667|141396129|SUPERIORITY|The difference in proportion responding between SOC+DZP 24mg/kg and SOC+PBO was estimated and tested using the Cochran-Mantel-Haenszel (CMH) risk difference estimate controlling for the randomization stratification factors, Pooled Region (North America vs Western Europe/Asia-Pacific vs Latin America/Eastern Europe), Screening disease activity (chronic active vs acute flaring) and Screening SLEDAI score (\<10 vs \>=10).|Difference in Proportions (%)|7.2||||0.1042|TWO_SIDED|95.0|-1.5|16.0|||Cochran-Mantel-Haenszel|||||16.0|-1.5|0.1042
70947678|NCT04294667|141396130|SUPERIORITY||Difference of Change(DZP+SOC vs PBO+SOC)|-1.8||||0.0001|TWO_SIDED|95.0|-2.7|-0.9|||MMRM|The Least Squares (LS) Mean, the difference (DZP+SOC versus PBO+SOC), and the 95% CIs was computed from the MMRM.||||-0.9|-2.7|0.0001
70947679|NCT04294667|141396135|SUPERIORITY|||||||0.0111|||||||Log Rank|||||||0.0111
70947680|NCT04294667|141396136|SUPERIORITY|||||||0.0228|||||||Log Rank|||||||0.0228
71133138|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.693||95.0|-0.43|0.64||P-value for Baseline: Evening Postprandial Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.64|-0.43|0.693
71133139|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.499||95.0|-0.38|0.77||P-value for Baseline: 0300 Hours.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.77|-0.38|0.499
71133140|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.59|||<|0.001||95.0|0.26|0.92||P-value for 12 Week: Morning Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.92|0.26|<0.001
71133141|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28||||0.278||95.0|-0.22|0.78||P-value for 12 Week: Morning Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.78|-0.22|0.278
71133142|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.53||||0.009||95.0|0.14|0.93||P-value for 12 Week: Midday Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.93|0.14|0.009
70947681|NCT03563313|141396166|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70947682|NCT03563313|141396167|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70947683|NCT03563313|141396168|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70947684|NCT03563313|141396169|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
70947685|NCT03563313|141396170|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70947686|NCT03563313|141396171|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||||||0.02
70947687|NCT00537329|141396219|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|86.1||||||95.0|70.5|95.3||||||Sample size enrollment of 100 subjects was planned. Assuming an overall response rate of 75 percent (%), a 95% confidence interval (CI) for the percentage of subjects responding to treatment would have ranged from 66.3% to 83.7% allowing for 5% nonevaluability. This would have provided a level of precision considered acceptable for this Asian regional study.||95.3|70.5|
70947688|NCT00537329|141396220|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|89.2||||||95.0|74.6|97.0||||||EOIT||97.0|74.6|
70947689|NCT00537329|141396220|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|82.8||||||95.0|64.2|94.2||||||2 Wks post EOT||94.2|64.2|
70947690|NCT00537329|141396220|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|89.5||||||95.0|66.9|98.7||||||6 Wks post EOT||98.7|66.9|
70947691|NCT00537329|141396220|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|72.7||||||95.0|49.8|89.3||||||12 Wks post baseline||89.3|49.8|
70947692|NCT00537329|141396221|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|97.1||||||95.0|85.1|99.9||||||EOIT: success (cure/improvement)||99.9|85.1|
70861110|NCT02869438|141208735|SUPERIORITY||Mean Difference (Final Values)|0.057||||0.1558|TWO_SIDED|95.0|-0.022|0.135|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For average over Day 28, 56, and 84|||0.135|-0.022|0.1558
70947693|NCT00537329|141396221|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|94.1||||||95.0|80.3|99.3||||||EOT: success (cure/improvement)||99.3|80.3|
70947694|NCT00537329|141396221|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|92.9||||||95.0|76.5|99.1||||||2 Wks post EOT: success (cure/improvement)||99.1|76.5|
71133143|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.49||||0.049||95.0|0.0|0.97||P-value for 12 Week: Midday Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.97|0.00|0.049
71133144|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77|||<|0.001||95.0|0.35|1.18||P-value for 12 Week: Evening Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||1.18|0.35|<0.001
71133145|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.17|||<|0.001||95.0|-1.63|-0.7||P-value for 12 Week: Evening Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||-0.70|-1.63|<0.001
71133146|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.506||95.0|-0.59|0.29||P-value for 12 Week: 0300 Hours.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.29|-0.59|0.506
71133147|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.65|||<|0.001||95.0|0.31|0.99||P-value for 24 Week: Morning Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.99|0.31|<0.001
71133148|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.42||||0.094||95.0|-0.07|0.91||P-value for 24 Week: Morning Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.91|-0.07|0.094
71133149|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.408||95.0|-0.24|0.59||P-value for 24 Week: Midday Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.59|-0.24|0.408
71133150|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23||||0.351||95.0|-0.25|0.71||P-value for 24 Week: Midday Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.71|-0.25|0.351
71133151|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56||||0.01||95.0|0.13|0.98||P-value for 24 Week: Evening Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.98|0.13|0.010
71133152|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48||||0.029||95.0|-0.92|-0.05||P-value for 24 Week: Evening Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||-0.05|-0.92|0.029
71133153|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.816||95.0|-0.45|0.35||P-value for 24 Week: 0300 Hours.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.35|-0.45|0.816
71133154|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.49||||0.008||95.0|0.13|0.85||P-value for 36 Week: Morning Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.85|0.13|0.008
71133155|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.438||95.0|-0.71|0.31||P-value for 36 Week: Morning Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.31|-0.71|0.438
71133156|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.548||95.0|-0.54|0.29||P-value for 36 Week: Midday Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.29|-0.54|0.548
71133157|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.964||95.0|-0.5|0.52||P-value for 36 Week: Midday Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.52|-0.50|0.964
71133158|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.453||95.0|-0.27|0.6||P-value for 36 Week: Evening Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.60|-0.27|0.453
71133159|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||0.096||95.0|-0.84|0.07||P-value for 36 Week: Evening Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.07|-0.84|0.096
71133160|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.77||95.0|-0.51|0.37||P-value for 36 Week: 0300 Hours.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.37|-0.51|0.770
71133161|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.45||||0.01||95.0|0.11|0.8||P-value for Endpoint: Morning Pre-Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.80|0.11|0.010
70861111|NCT02869438|141208736|SUPERIORITY||Mean Difference (Final Values)|-0.176||||0.2847|TWO_SIDED|95.0|-0.505|0.153|||Mixed Models Analysis|Model includes covariates of treatment, baseline RV, region, visit, treatment by visit interaction.||||0.153|-0.505|0.2847
70861112|NCT02869438|141208737|SUPERIORITY||Mean Difference (Final Values)|-101.0|||<|0.0001|TWO_SIDED|95.0|-118.9|-83.06|||Mixed Models Analysis|Model includes covariates of treatment, baseline eosinophils counts, region, visit, treatment by visit interaction.||||-83.06|-118.9|<0.0001
71133162|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31||||0.201||95.0|-0.8|0.17||P-value for Endpoint: Morning Postprandial Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.17|-0.80|0.201
70861113|NCT02869438|141208738|SUPERIORITY||Mean Difference (Final Values)|0.015||||0.6384|TWO_SIDED|95.0|-0.049|0.08|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 3|||0.08|-0.049|0.6384
70861114|NCT02869438|141208738|SUPERIORITY||Mean Difference (Final Values)|0.046||||0.148|TWO_SIDED|95.0|-0.016|0.109|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 7|||0.109|-0.016|0.148
70861115|NCT02869438|141208738|SUPERIORITY||Mean Difference (Final Values)|0.026||||0.4959|TWO_SIDED|95.0|-0.049|0.101|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 14|||0.101|-0.049|0.4959
70861116|NCT02869438|141208739|SUPERIORITY||Mean Difference (Final Values)|0.006||||0.8667|TWO_SIDED|95.0|-0.062|0.073|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 3|||0.073|-0.062|0.8667
70861117|NCT02869438|141208739|SUPERIORITY||Mean Difference (Final Values)|0.041||||0.2734|TWO_SIDED|95.0|-0.033|0.115|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 7|||0.115|-0.033|0.2734
70861118|NCT02869438|141208739|SUPERIORITY||Mean Difference (Final Values)|0.015||||0.7252|TWO_SIDED|95.0|-0.068|0.098|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 14|||0.098|-0.068|0.7252
70861119|NCT02869438|141208739|SUPERIORITY||Mean Difference (Final Values)|0.075||||0.0976|TWO_SIDED|95.0|-0.014|0.164|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 28|||0.164|-0.014|0.0976
70861120|NCT02869438|141208739|SUPERIORITY||Mean Difference (Final Values)|0.023||||0.6536|TWO_SIDED|95.0|-0.077|0.122|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 56|||0.122|-0.077|0.6536
70861121|NCT02869438|141208739|SUPERIORITY||Mean Difference (Final Values)|0.092||||0.0595|TWO_SIDED|95.0|-0.004|0.188|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 84|||0.188|-0.004|0.0595
70861122|NCT02869438|141208739|SUPERIORITY||Mean Difference (Final Values)|0.063||||0.1377|TWO_SIDED|95.0|-0.02|0.147|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For average of Day 28, 56, 84.|||0.147|-0.02|0.1377
70861123|NCT02869438|141208740|SUPERIORITY||Odds Ratio (OR)|1.49||||0.1604|TWO_SIDED|95.0|0.85|2.58|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 3|||2.58|0.85|0.1604
70861124|NCT02869438|141208740|SUPERIORITY||Odds Ratio (OR)|1.29||||0.34|TWO_SIDED|95.0|0.76|2.19|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 7|||2.19|0.76|0.3400
70861125|NCT02869438|141208740|SUPERIORITY||Odds Ratio (OR)|1.58||||0.0924|TWO_SIDED|95.0|0.93|2.7|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 14|||2.70|0.93|0.0924
70861126|NCT02869438|141208740|SUPERIORITY||Odds Ratio (OR)|1.57||||0.1052|TWO_SIDED|95.0|0.91|2.71|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 28|||2.71|0.91|0.1052
70947695|NCT00537329|141396221|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|94.4||||||95.0|72.7|99.9||||||6 Wks post EOT: success (cure/improvement)||99.9|72.7|
70861127|NCT02869438|141208740|SUPERIORITY||Odds Ratio (OR)|1.3||||0.3271|TWO_SIDED|95.0|0.77|2.21|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 56|||2.21|0.77|0.3271
70861128|NCT02869438|141208740|SUPERIORITY||Odds Ratio (OR)|1.33||||0.3017|TWO_SIDED|95.0|0.77|2.29|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 84|||2.29|0.77|0.3017
70861129|NCT02869438|141208741|SUPERIORITY||Mean Difference (Final Values)|-0.293||||0.0024|TWO_SIDED|95.0|-0.481|-0.105|||Mixed Models Analysis|Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.|For Day 14|||-0.105|-0.481|0.0024
70861130|NCT02869438|141208741|SUPERIORITY||Mean Difference (Final Values)|-0.402||||0.0002|TWO_SIDED|95.0|-0.609|-0.195|||Mixed Models Analysis|Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.|For Day 28|||-0.195|-0.609|0.0002
70861131|NCT02869438|141208741|SUPERIORITY||Mean Difference (Final Values)|-0.312||||0.0117|TWO_SIDED|95.0|-0.554|-0.07|||Mixed Models Analysis|Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.|For Day 56|||-0.07|-0.554|0.0117
70861132|NCT02869438|141208741|SUPERIORITY||Mean Difference (Final Values)|-0.472||||0.0004|TWO_SIDED|95.0|-0.731|-0.213|||Mixed Models Analysis|Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.|For Day 84|||-0.213|-0.731|0.0004
70861133|NCT02869438|141208741|SUPERIORITY||Mean Difference (Final Values)|-0.395||||0.0002|TWO_SIDED|95.0|-0.603|-0.188|||Mixed Models Analysis|Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.|For average of Day 28, 56, 84.|||-0.188|-0.603|0.0002
70861134|NCT02869438|141208742|SUPERIORITY||Mean Difference (Final Values)|-7.229||||0.0001|TWO_SIDED|95.0|-10.832|-3.626|||Mixed Models Analysis|Model includes covariates of treatment, baseline SGRQ score, region, visit, treatment by visit interaction.|For Day 28|||-3.626|-10.832|0.0001
70947696|NCT00537329|141396221|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|85.0||||||95.0|62.1|96.8||||||12 Wks post baseline: success (cure/improvement)||96.8|62.1|
70947697|NCT00537329|141396222|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|97.3||||||95.0|85.8|99.9||||||EOIT: success (erad/presumed erad)||99.9|85.8|
70947698|NCT00537329|141396222|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|97.1||||||95.0|85.1|99.9||||||EOT: success (erad/presumed erad)||99.9|85.1|
70947699|NCT00537329|141396222|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|86.2||||||95.0|68.3|96.1||||||2 Wks post EOT: success (erad/presumed erad)||96.1|68.3|
70947700|NCT00537329|141396222|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|94.4||||||95.0|72.7|99.9||||||6 Wks post EOT: success (erad/presumed erad)||99.9|72.7|
71133163|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16||||0.43||95.0|-0.57|0.24||P-value for Endpoint: Midday Pre-Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.24|-0.57|0.430
71133164|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.814||95.0|-0.52|0.41||P-value for Endpoint: Midday Postprandial Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.41|-0.52|0.814
71133165|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.427||95.0|-0.24|0.57||P-value for Endpoint: Evening Pre-Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.57|-0.24|0.427
71133166|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57||||0.009||95.0|-1.0|-0.14||P-value for Endpoint: Evening Postprandial Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||-0.14|-1.00|0.009
71133167|NCT00377858|141769386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.569||95.0|-0.51|0.28||P-value for Endpoint: 0300 Hours. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.28|-0.51|0.569
71133168|NCT00377858|141769387|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.776||95.0|-0.14|0.19||P-value for Baseline MODD.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.19|-0.14|0.776
71133169|NCT00377858|141769387|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.27||||0.737||95.0|-6.14|8.68||P-value for Baseline M-Value.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||8.68|-6.14|0.737
71133170|NCT00377858|141769387|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.701||95.0|-0.19|0.13||P-value for 12 Week MODD.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.13|-0.19|0.701
71133171|NCT00377858|141769387|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.58||||0.4||95.0|-2.11|5.27||P-value for 12 Week M-Value.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||5.27|-2.11|0.400
71133172|NCT00377858|141769387|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.321||95.0|-0.26|0.09||P-value for 24 Week MODD.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.09|-0.26|0.321
71133173|NCT00377858|141769387|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.52||||0.179||95.0|-1.16|6.21||P-value for 24 Week M-Value.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||6.21|-1.16|0.179
71133174|NCT00377858|141769387|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.573||95.0|-0.22|0.12||P-value for 36 Week MODD.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.12|-0.22|0.573
71133175|NCT00377858|141769387|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.95||||0.629||95.0|-4.79|2.9||P-value for 36 Week M-Value.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||2.90|-4.79|0.629
71133176|NCT00377858|141769387|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.25||95.0|-0.26|0.07||P-value for Endpoint MODD. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.07|-0.26|0.250
71133177|NCT00377858|141769387|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.72||||0.362||95.0|-5.44|1.99||P-value for Endpoint M-Value.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||1.99|-5.44|0.362
71133178|NCT00377858|141769388|SUPERIORITY_OR_OTHER|||||||0.094||95.0||||P-value for Endpoint Hypoglycemic Episodes.|Fisher Exact|||||||0.094
71133179|NCT00377858|141769388|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for Overall Hypoglycemic Episodes.|Fisher Exact|||||||1.00
71133180|NCT00377858|141769388|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||P-value for Endpoint Nocturnal Hypoglycemic Episodes.|Fisher Exact|||||||0.430
71133181|NCT00377858|141769388|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for Overall Nocturnal Hypoglycemic Episodes.|Fisher Exact|||||||1.00
70861135|NCT02869438|141208742|SUPERIORITY||Mean Difference (Final Values)|-5.942||||0.0115|TWO_SIDED|95.0|-10.538|-1.346|||Mixed Models Analysis|Model includes covariates of treatment, baseline SGRQ score, region, visit, treatment by visit interaction.|For Day 56|||-1.346|-10.538|0.0115
70861136|NCT02869438|141208742|SUPERIORITY||Mean Difference (Final Values)|-8.599||||0.0004|TWO_SIDED|95.0|-13.3|-3.898|||Mixed Models Analysis|Model includes covariates of treatment, baseline SGRQ score, region, visit, treatment by visit interaction.|For Day 84|||-3.898|-13.3|0.0004
70861137|NCT02869438|141208742|SUPERIORITY||Mean Difference (Final Values)|-7.257||||0.0003|TWO_SIDED|95.0|-11.133|-3.38|||Mixed Models Analysis|Model includes covariates of treatment, baseline SGRQ score, region, visit, treatment by visit interaction.|For average of Day 28, 56, 84.|||-3.38|-11.133|0.0003
71133182|NCT00377858|141769388|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Endpoint Non-Nocturnal Hypoglycemic Episodes.|Fisher Exact|||||||0.013
71133183|NCT00377858|141769388|SUPERIORITY_OR_OTHER|||||||0.756||95.0||||P-value for Overall Non-Nocturnal Hypoglycemic Episodes.|Fisher Exact|||||||0.756
71133184|NCT00377858|141769389|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for Endpoint Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.||||||0.022
71133185|NCT00377858|141769389|SUPERIORITY_OR_OTHER|||||||0.218||95.0||||P-value for Overall Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.||||||0.218
71133186|NCT00377858|141769389|SUPERIORITY_OR_OTHER|||||||0.311||95.0||||P-value for Endpoint Nocturnal Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.||||||0.311
71133187|NCT00377858|141769389|SUPERIORITY_OR_OTHER|||||||0.615||95.0||||P-value for Overall Nocturnal Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.||||||0.615
71133188|NCT00377858|141769389|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||P-value for Endpoint Non-Nocturnal Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.||||||0.018
71133189|NCT00377858|141769389|SUPERIORITY_OR_OTHER|||||||0.255||95.0||||P-value for Overall Non-Nocturnal Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.||||||0.255
71133190|NCT00377858|141769390|SUPERIORITY_OR_OTHER|||||||0.416||95.0||||P-value for Overall Severe Hypoglycemic Episodes.|Fisher Exact|||||||0.416
71133191|NCT00377858|141769391|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08|||<|0.001||95.0|-0.12|-0.05||P-value for Daily Basal.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||-0.05|-0.12|<0.001
71133192|NCT00377858|141769391|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|||<|0.001||95.0|0.04|0.11||P-value for Daily Prandial.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.11|0.04|<0.001
71133193|NCT00377858|141769391|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.017||95.0|0.01|0.12||P-value for Daily Total.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.12|0.01|0.017
71133194|NCT00377858|141769392|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.96|||<|0.001||95.0|-9.65|-4.26||P-value for Daily Basal.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||-4.26|-9.65|<0.001
71133195|NCT00377858|141769392|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.05|||<|0.001||95.0|3.39|8.71||P-value for Daily Prandial.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||8.71|3.39|<0.001
71133196|NCT00377858|141769392|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.2||||0.017||95.0|0.93|9.46||P-value for Daily Total.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||9.46|0.93|0.017
70861138|NCT02869438|141208743|SUPERIORITY||Mean Difference (Final Values)|5.414||||0.2825|TWO_SIDED|95.0|-4.492|15.321|||Mixed Models Analysis|Model includes covariates of treatment, baseline FeNO value, region, visit, treatment by visit interaction.||||15.321|-4.492|0.2825
70947701|NCT00537329|141396222|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|84.2||||||95.0|60.4|96.6||||||12 Wks post baseline: success (erad/presumed erad)||96.6|60.4|
71133197|NCT00377858|141769393|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33|||<|0.001||95.0|0.24|0.42||P-value for Week 12.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.42|0.24|<0.001
71133198|NCT00377858|141769393|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22||||0.003||95.0|0.07|0.36||P-value for Week 24.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.36|0.07|0.003
71133199|NCT00377858|141769393|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24||||0.002||95.0|0.09|0.4||P-value for Week 30.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.40|0.09|0.002
71133200|NCT00377858|141769393|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22||||0.005||95.0|0.07|0.38||P-value for Week 36.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.38|0.07|0.005
71133201|NCT00377858|141769393|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.19||||0.011||95.0|0.04|0.34||P-value for Endpoint. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.34|0.04|0.011
71133202|NCT00377858|141769394|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.803||95.0|-0.8|0.62||P-value for Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Sulfonylurea stratum + Country + Baseline HbA1c stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.62|-0.80|0.803
71133203|NCT04034004|141769401|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||Pain ratings were collected while lying in the supine and after each straight leg rasise test (SLR 1; SLR 2). A 2 (group) X 2 (SLR 1-rest vs. SLR 2-meditation) X 2 (supine vs. SLR) X 3 (session) repeated measure mixed model ANOVA was conducted to determine if mindfulness and non-mindfulness meditation attenuate SLR induced pain through endogenous opioids. Simple effects tests tested significant main effects and interactions to test primary study hypotheses and between-group differences.||||.05
71133204|NCT01345188|141769407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.058|||||||Paired t test|||||||0.058
71133205|NCT01345188|141769408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.048|||||||Paired t test|||||||0.048
71133206|NCT01345188|141769409|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Wilcoxon Signed rank|||||||>0.05
71133207|NCT01397461|141769410|SUPERIORITY_OR_OTHER|||||||0.003|||||||Chi-squared|||"The treatment comparison was done using only the outcomes of Clinical success and Clinical failure. The p value of the chi square test (without continuity correction) and corresponding 95% asymptotic (Wald) CI for the difference in success rates for the ozenoxacin versus placebo were provided. The analysis was performed to test the superiority of ozenoxacin versus placebo.~Text extracted from the statistical analysis plan. No additional data was pre-specified for the statistical comparison"||||0.003
71133208|NCT05729568|141769416|SUPERIORITY||Difference in least-squares means|-56.0||||0.1436|TWO_SIDED|95.0|-132.0|20.0|||ANCOVA||Difference in least-squares means (Diff in LSM), and its 95% CI were from ANCOVA model of change from baseline CD4 cell count with treatment as fixed effect and baseline CD4 cell count as a covariate.|||20|-132|0.1436
70947702|NCT00537329|141396229|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|50.0||||||95.0|1.3|98.7||||||Neutropenic status: ANC ≤ 500/cmm||98.7|1.3|
70947703|NCT00537329|141396229|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|75.7||||||95.0|58.8|88.2||||||Neutropenic status: ANC \> 500/cmm||88.2|58.8|
70947704|NCT00537329|141396229|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|71.4||||||95.0|41.9|91.6||||||Baseline pathogen: Candida albicans||91.6|41.9|
70947705|NCT00537329|141396229|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|66.7||||||95.0|22.3|95.7||||||Baseline pathogen: Candida glabrata||95.7|22.3|
71133209|NCT04181762|141769429|SUPERIORITY||Mean Difference (Final Values)|-12.7||||0.0662|TWO_SIDED|95.0|-26.3|0.9|||Regression, Logistic||Difference from placebo and 95% CI are from a logistic regression model with treatment group, stratification factor (SoC) and race as factors and baseline UPCR as a covariate using marginal standardization method.|Complete Renal Response (CRR) at Week 52||0.9|-26.3|0.0662
71133210|NCT04181762|141769431|OTHER||Mean Difference (Final Values)|-7.7|||||TWO_SIDED|95.0|-23.7|8.4|||||95% Confidence Intervals (CIs) are constructed using the exact binomial test.|Partial Renal Response (PRR) at Week 52||8.4|-23.7|
70947706|NCT00537329|141396229|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|100.0||||||95.0|39.8|100.0||||||Baseline pathogen: Candida parapsilosis||100.0|39.8|
71133211|NCT00195663|141769472|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical tests were performed in a hierarchical manner. If there was a statistically significant difference in favor of adalimumab + MTX combination treatment, the second primary analysis of the modified Total Sharp Score was to be performed.|Chi-squared, Corrected|||The study was powered to demonstrate the superiority of adalimumab + MTX combination therapy vs. MTX monotherapy in the proportion of subjects who achieved an ACR50 response at 52 weeks. Power calculations were based on 250 subjects in each group using a chi-squared test with a continuity correction and an alpha = 0.05 significance level. With 250 subjects in each group, a difference of 0.13 in response rates could be detected with 80% power.||||<0.001
71133212|NCT00195663|141769473|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||Statistical tests were performed in a hierarchical manner. If there was a statistically significant difference in favor of adalimumab + MTX combination treatment on the ACR50 response, the second primary analysis of modified TSS would be performed.||||<0.001
71133213|NCT00195663|141769474|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71133214|NCT00195663|141769475|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
71133215|NCT00195663|141769476|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||< 0.001
71133216|NCT00195663|141769477|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
71133217|NCT00195663|141769478|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||< 0.001
71133218|NCT00195663|141769479|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
71133219|NCT00195663|141769480|SUPERIORITY_OR_OTHER|||||||0.5402||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5402
71133220|NCT02058563|141769527|NON_INFERIORITY_OR_EQUIVALENCE|Criteria for the determination of non-inferiority for measles, mumps, and rubella viruses: Lower limit (LL) of the 2-sided 95% Confidence Interval (CI) on GMC ratio (INV\_MMR over COM\_MMR) was to be equal to or above 0.67 for anti-measles, anti-mumps, and anti rubella antibodies.|Adjusted GMC ratio|1.0|||||TWO_SIDED|95.0|0.91|1.11|||||Number of subjects in the INV-MMR Group and in the COM-MMR Group considered for calculating the adjusted GMC ratio, are respectively 432 and 435 and adjusted GMCs = 1790.2 (LL=1669.6;UL=1919.5) and 1781.5 (LL=1661.8;UL=1909.7) respectively|Non-inferiority of INV\_MMR vaccine to COM\_MMR vaccine in terms of Geometric Mean Concentration (GMCs) for anti measles, anti mumps and anti rubella antibodies at Day 42.The 95% CI for adjusted geometric mean concentrations (GMCs) and the adjusted GMC ratio were obtained using an ANCOVA model on the logarithm-transformed concentrations including the vaccine group (for adjusted GMC ratio) as fixed effect, gender, age and country groups as continuous effects and the pre-vaccination log-transformed||1.11|0.91|
71133221|NCT02058563|141769528|NON_INFERIORITY_OR_EQUIVALENCE|Criteria for the determination of non-inferiority for measles, mumps, and rubella viruses: Lower limit (LL) of the 2-sided 95% Confidence Interval (CI) on GMC ratio (INV\_MMR over COM\_MMR) was to be equal to or above 0.67 for anti-measles, anti-mumps, and anti rubella antibodies.|Adjusted GMC ratio|1.05|||||TWO_SIDED|95.0|0.96|1.16|||||Number of subjects in the INV-MMR Group and in the COM-MMR Group considered for calculating the adjusted GMC ratio, are respectively 432 and 435 and adjusted GMCs = 113.5 (LL=106.0;UL=121.6) and 107.8 (LL=100.7;UL=115.4) respectively.|Non-inferiority of INV\_MMR vaccine to COM\_MMR vaccine in terms of Geometric Mean Concentration (GMCs) for anti measles, anti mumps and anti rubella antibodies at Day 42.The 95% CI for adjusted geometric mean concentrations (GMCs) and the adjusted GMC ratio were obtained using an ANCOVA model on the logarithm-transformed concentrations including the vaccine group (for adjusted GMC ratio) as fixed effect, gender, age and country groups as continuous effects and the pre-vaccination log-transformed.||1.16|0.96|
71133222|NCT02058563|141769529|NON_INFERIORITY_OR_EQUIVALENCE|Criteria for the determination of non-inferiority for measles, mumps, and rubella viruses: Lower limit (LL) of the 2-sided 95% Confidence Interval (CI) on GMC ratio (INV\_MMR over COM\_MMR) was to be equal to or above 0.67 for anti-measles, anti-mumps, and anti rubella antibodies.|Adjusted GMC ratio|1.02|||||TWO_SIDED|95.0|0.93|1.11|||||Number of subjects in the INV-MMR Group and in the COM-MMR Group considered for calculating the adjusted GMC ratio, are respectively 432 and 435 and adjusted GMCs = 76.1 (LL=71.5;UL=81.0) and 74.6 (LL=70.2;UL=79.4) respectively.|Non-inferiority of INV\_MMR vaccine to COM\_MMR vaccine in terms of Geometric Mean Concentration (GMCs) for anti measles, anti mumps and anti rubella antibodies at Day 42.The 95% CI for adjusted geometric mean concentrations (GMCs) and the adjusted GMC ratio were obtained using an ANCOVA model on the logarithm-transformed concentrations including the vaccine group (for adjusted GMC ratio) as fixed effect, gender, age and country groups as continuous effects and the pre-vaccination log-transformed||1.11|0.93|
71133223|NCT04522141|141769555|OTHER|||||||0.038||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.038
71133224|NCT04522141|141769555|SUPERIORITY|||||||0.941||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.941
70947707|NCT00537329|141396229|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|100.0||||||95.0|2.5|100.0||||||Baseline pathogen: Candida rugosa||100.0|2.5|
70947708|NCT00537329|141396229|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|72.2||||||95.0|46.5|90.3||||||Baseline pathogen: Candida tropicalis||90.3|46.5|
70947709|NCT00537329|141396229|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|84.6||||||95.0|54.6|98.1||||||Previous surgery: Any surgery||98.1|54.6|
70861139|NCT02869438|141208753|SUPERIORITY||Mean Difference (Final Values)|-0.365||||0.012|TWO_SIDED|95.0|-0.649|-0.081|||Mixed Models Analysis|Model includes covariates of treatment, baseline PGI-S score, region, visit, treatment by visit interaction.|For Day 84|||-0.081|-0.649|0.0120
70872122|NCT02155608|141229495|SUPERIORITY|||||||0.81|||||||Mixed Models Analysis|Group \* time: F = .06, df = 1/52||Phase 1 a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interaction to test for treatment effects.||||.81
70947710|NCT00537329|141396229|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|87.5||||||95.0|47.3|99.7||||||Previous surgery: Abdominal surgery||99.7|47.3|
70947711|NCT00537329|141396229|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|58.8||||||95.0|32.9|81.6||||||Elderly: Age ≥ 65 years||81.6|32.9|
70947712|NCT00537329|141396229|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|54.5||||||95.0|23.4|83.3||||||Renal insufficiency (CCC \< 30 mL/min)||83.3|23.4|
71133225|NCT04522141|141769556|OTHER|||||||0.003||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.003
71133226|NCT04522141|141769556|SUPERIORITY|||||||0.027||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.027
70947713|NCT00537329|141396229|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|81.0||||||95.0|58.1|94.6||||||Use of Central venous catheter = Yes||94.6|58.1|
70861140|NCT02869438|141208754|SUPERIORITY||Odds Ratio (OR)|2.97||||0.0018|TWO_SIDED|95.0|1.5|5.88|||Regression, Logistic|Model includes covariates of treatment, region.|For Day 84|Responder analysis: responder is defined as Very much improved, improved, and minimally improved.||5.88|1.50|0.0018
70947714|NCT00537329|141396229|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|71.4||||||95.0|29.0|96.3||||||Receiving chemotherapy = Yes||96.3|29.0|
70947715|NCT02138253|141396236|SUPERIORITY|For the primary efficacy analysis based on the Month 24 biopsy, subjects with a missing Month 24 biopsy had their Ishak fibrosis score imputed. Imputation of missing Ishak fibrosis scores was conducted using multiple imputation (MI). Results were imputed based on age, gender, baseline Ishak fibrosis score, and the Month 12 Ishak fibrosis score.|Risk Difference (RD)|2.9||||0.73|TWO_SIDED|95.0|-20.5|26.4||Stratified by baseline Ishak Fibrosis Score strata (F2, F3+F4+F5, and F6).|Cochran-Mantel-Haenszel|||All screening and post-baseline biopsy data collected were used in the primary analysis, irrespective of the defined protocol visit window. Classification of the Ishak fibrosis score was summarized descriptively by treatment group at baseline, Month 12, and Month 24. Response at Months 12 and 24 were summarized descriptively by treatment group, along with exact (Clopper-Pearson) 95% confidence intervals (CIs). The risk difference between groups was also was provided with its 95% CI.||26.4|-20.5|0.73
70947716|NCT02138253|141396237|SUPERIORITY||Risk Difference (RD)|4.4||||0.658|TWO_SIDED|95.0|-20.0|28.9|||Cochran-Mantel-Haenszel|||All screening and post-baseline biopsy data collected were used in the primary analysis, irrespective of the defined protocol visit window. Classification of the Ishak fibrosis score was summarized descriptively by treatment group at baseline, Month 12, and Month 24. Response at Months 12 and 24 were summarized descriptively by treatment group, along with exact (Clopper-Pearson) 95% confidence intervals (CIs). The risk difference between groups was also was provided with its 95% CI.||28.9|-20.0|0.658
71133227|NCT04522141|141769557|OTHER||||||<|0.001||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||< .001
71133228|NCT04522141|141769557|SUPERIORITY|||||||0.411||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.411
71133229|NCT04522141|141769558|OTHER||||||<|0.001||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status|Mixed Models Analysis|||Main effect weekly self-control||||< .001
71133230|NCT04522141|141769558|SUPERIORITY|||||||0.176||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status|Mixed Models Analysis|||Time by condition interaction weekly self-control||||0.176
71133231|NCT04522141|141769559|OTHER||||||>|0.05||||||Analyses are controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||> .05
71133232|NCT04522141|141769559|SUPERIORITY||||||>|0.05||||||Analyses are controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||> .05
71133233|NCT04522141|141769560|OTHER|||||||0.031||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.031
71133234|NCT04522141|141769560|SUPERIORITY|||||||0.26|||||||Mixed Models Analysis|Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.||Time by condition interaction||||0.260
71133235|NCT04522141|141769561|OTHER|||||||0.016||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.016
71133236|NCT04522141|141769561|SUPERIORITY|||||||0.363||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.363
71133237|NCT04522141|141769562|OTHER||||||>|0.05||||||Analyses are controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||> .05
71133238|NCT04522141|141769562|SUPERIORITY||||||>|0.05||||||Analyses are controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||> .05
71133239|NCT04522141|141769563|OTHER|||||||0.389||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.389
71133240|NCT04522141|141769563|SUPERIORITY|||||||0.516||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.516
71133241|NCT04522141|141769564|OTHER|||||||0.005||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.005
71133242|NCT04522141|141769564|SUPERIORITY|||||||0.555||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.555
71133243|NCT04522141|141769565|OTHER|||||||0.206||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.206
71133244|NCT04522141|141769565|SUPERIORITY|||||||0.026||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.026
71133245|NCT00555217|141769573|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.3|TWO_SIDED|95.0|0.7|1.12|||Log Rank||Combination ARB and ACEI vs. mono therapy ARB|||1.12|0.70|0.30
71133246|NCT00555217|141769574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.1|TWO_SIDED|95.0|0.58|1.05|||Log Rank||Combination ARB and ACEI vs. mono therapy ARB|||1.05|0.58|0.10
71133247|NCT00367835|141769576|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71133248|NCT00367835|141769577|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71133249|NCT00367835|141769578|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
71133250|NCT00367835|141769579|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
71133251|NCT00367835|141769580|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71133252|NCT00367835|141769581|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||ANCOVA|||||||0.002
71133253|NCT00367835|141769582|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71133254|NCT01025830|141769589|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was defined as a 90% Confidence Interval of the geometric mean ratio between 0.8 and 1.25. Differences between treatments with respect to the outcome and intra- and inter-subject variances were assessed using the mixed effects model. Bootstrapped random errors were used.|Geometric Mean Ratio|1.1||||||90.0|0.87|1.38||p value not required for this analysis. What counts is the 90% confidence interval of the geometric mean ratio between the two formulation parameters.|Non-compartmental model|Mixed random effects model was used to assess difference between treatments and intra- and inter-subject variances.|the generic is the numerator while the brand is the denominator|The null hypothesis was that there is a difference in the relative bioavailability of Triomune and brand-name stavudine/lamivudine/nevirapine in HIV-infected Africans. 18 participants were required to provide 80% power to detect approximately a 20% difference on a log scale in AUC0-12h between the brand formulation and the generic formulation. Alpha level of 0.05.||1.38|0.87|
71133255|NCT01025830|141769589|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was defined as a 90% Confidence Interval of the geometric mean ratio between 0.8 and 1.25. Differences between treatments with respect to the outcome and intra- and inter-subject variances were assessed using the mixed effects model. Bootstrapped random errors were used.|Geometric Mean Ratio|1.1||||||90.0|0.95|1.31||p value not required for this analysis. What counts is the 90% confidence interval of the geometric mean ratio between the two formulation parameters.|Non-compartmental model|Mixed random effects model was used to assess difference between treatments and intra- and inter-subject variances.|the generic is the numerator while the brand is the denominator|The null hypothesis was that there is a difference in the relative bioavailability of Triomune and brand-name stavudine/lamivudine/nevirapine in HIV-infected Africans. 18 participants were required to provide 80% power to detect approximately a 20% difference on a log scale in AUC0-12h between the brand formulation and the generic formulation. Alpha level of 0.05.||1.31|0.95|
71133256|NCT01025830|141769589|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was defined as a 90% Confidence Interval of the geometric mean ratio between 0.8 and 1.25. Differences between treatments with respect to the outcome and intra- and inter-subject variances were assessed using the mixed effects model. Bootstrapped random errors were used.|Geometric Mean Ratio|0.8||||||90.0|0.65|0.99||p value not required for this analysis. What counts is the 90% confidence interval of the geometric mean ratio between the two formulation parameters.|Non-compartmental model|Mixed random effects model was used to assess difference between treatments and intra- and inter-subject variances.|the generic is the numerator while the brand is the denominator|The null hypothesis was that there is a difference in the relative bioavailability of Triomune and brand-name stavudine/lamivudine/nevirapine in HIV-infected Africans. 18 participants were required to provide 80% power to detect approximately a 20% difference on a log scale in AUC0-12h between the brand formulation and the generic formulation. Alpha level of 0.05.||0.99|0.65|
71133257|NCT01025830|141769590|NON_INFERIORITY_OR_EQUIVALENCE|same as for AUC|Geometric Mean Ratio|1.3||||||90.0|0.99|1.71||same as for AUC|Non-compartmental model|same as for AUC|same as AUC|Same as for AUC||1.71|0.99|
71133258|NCT01025830|141769590|NON_INFERIORITY_OR_EQUIVALENCE|same for all three drugs.|Geometric Mean Ratio|1.1||||||90.0|0.95|1.23||Same for all three drugs.|Non-compartmental model|Same for all three drugs.|Same for all three drugs.|Same for all three drugs.||1.23|0.95|
71133259|NCT01025830|141769590|NON_INFERIORITY_OR_EQUIVALENCE|Same for all three drugs.|Geometric Mean Ratio|0.8||||||90.0|0.63|0.98||Same for all three drugs.|Non-compartmental model|Same for all three drugs.|Same for all three drugs.|Same for all three drugs.||0.98|0.63|
71133260|NCT00264537|141769643|SUPERIORITY_OR_OTHER|||||||0.053||||||A positive test is concluded if there is a significant difference between golimumab+MTX and placebo+MTX and at least one of the pair-wise comparisons at a 0.05 level.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening CRP (\< 1.5 mg/dL; \>= 1.5 mg/dL)||Null hypothesis: No difference in ACR 50 response comparing Group 1 vs combined Groups 3 and 4. The sample size of 150 patients per treatment group will provide \>98% power to detect a difference in ACR 50 response between treatment groups at alpha=0.05, assuming 50% of patients with screening C-reactive protein (CRP)\<1.5mg/dL, and the difference in ACR 50 response of 15-20% in patients with screening CRP\<1.5mg/dL and 20-25% in subjects with screening CRP\>=1.5mg/dL, between Groups 1 vs 3 or 4||||0.053
71133261|NCT00264537|141769643|SUPERIORITY_OR_OTHER|||||||0.042|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||Null hypothesis: No difference in ACR 50 response comparing Groups 1 vs 3.||||0.042
71133262|NCT00264537|141769643|SUPERIORITY_OR_OTHER|||||||0.177|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||Null hypothesis: No difference in ACR 50 response comparing Groups 1 vs 4.||||0.177
70947717|NCT02138253|141396238|SUPERIORITY||Risk Difference (RD)|-7.9||||0.421|TWO_SIDED|95.0|-28.8|13.1|||Cochran-Mantel-Haenszel|||All screening and post-baseline biopsy data collected were used in the primary analysis, irrespective of the defined protocol visit window. Classification of the Ishak fibrosis score was summarized descriptively by treatment group at baseline, Month 12, and Month 24. Response at Months 12 and 24 were summarized descriptively by treatment group, along with exact (Clopper-Pearson) 95% confidence intervals (CIs). The risk difference between groups was also was provided with its 95% CI.||13.1|-28.8|0.421
70861141|NCT02869438|141208755|SUPERIORITY||Odds Ratio (OR)|2.51||||0.0107|TWO_SIDED|95.0|1.24|5.09|||Regression, Logistic|Model includes covariates of treatment, region.|For Day 84|Responder analysis: responder is defined as Very much improved, improved, and minimally improved.||5.09|1.24|0.0107
70947718|NCT02725528|141396263|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
71133263|NCT00264537|141769643|NON_INFERIORITY_OR_EQUIVALENCE|This sample size (150 patients per treatment group) will provide approximately 85% power to claim non-inferiority of golimumab alone (Group 2) compared with MTX alone (Group 1) at alpha= 0.05 using a one-sided equivalence test assuming the proportion of golimumab alone (Group 2) treated patients with ACR 50 response is not less than 10% compared with proportion of patients with ACR 50 response in MTX alone (Group 1) treated group.|Difference in ACR 50 Response Rate(%)|3.3||||0.521||95.0|-6.8||The upper bound of 95% CI was not produced because it was not relevant to the pre-specified analysis||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)|The positive difference indicates in favor of golimumab+placebo compared to placebo+MTX; The upper bound of CI is not applicable.|"Null hypothesis: Group 2 is inferior to Group 1. Noninferiority of golimumab will be demonstrated if the lower bound of the 2-sided 95% CI is above -10%. The 10% non-inferiority margin was chosen because this difference is not clinically admissible. Under the above noted assumed response rates, this corresponds to preservation of at least 70% \[(33% - 10%)/33%\*100\] of the expected MTX benefit."|||-6.8|0.521
70947719|NCT02725528|141396264|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
70861142|NCT02169284|141208779|OTHER|||||||0.208|||||||Wilcoxon rank-sum test|||Nucleus P-EGFR in benign tissue between erlotinib and placebo||||0.208
71133264|NCT00264537|141769644|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.011
71133265|NCT00264537|141769644|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Cochran-Mantel-Haenszel|CMH test stratified by screening CRP (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.028
71133266|NCT00264537|141769644|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Cochran-Mantel-Haenszel|CMH test stratified by screening CRP (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.028
71133267|NCT00264537|141769644|SUPERIORITY_OR_OTHER|||||||0.677||95.0|||||Cochran-Mantel-Haenszel|CMH test stratified by screening CRP (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.677
71133268|NCT00264537|141769645|SUPERIORITY_OR_OTHER|||||||0.178||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.178
71133269|NCT00264537|141769645|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.250
70861143|NCT02169284|141208779|OTHER|||||||0.208|||||||Wilcoxon rank-sum test|||Cytoplasm P-EGFR in benign tissue between erlotinib and placebo||||0.208
70861144|NCT02169284|141208779|OTHER|||||||0.272|||||||Wilcoxon rank-sum test|||Membrane P-EGFR in benign tissue between erlotinib and placebo||||0.272
70861145|NCT02169284|141208779|OTHER|||||||0.22|||||||Wilcoxon rank-sum test|||Entire Cell P-EGFR in benign tissue between erlotinib and placebo||||0.220
70861146|NCT02169284|141208780|OTHER|||||||0.361|||||||Wilcoxon rank-sum test|||Nucleus P-EGFR in Tumor Tissue, p-value between placebo and Erlotinib||||0.361
71133270|NCT00264537|141769645|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.240
70861147|NCT02169284|141208780|OTHER|||||||0.383|||||||Wilcoxon rank-sum test|||Cytoplasm P-EGFR in Tumor Tissue, p-value between placebo and Erlotinib||||0.383
71133271|NCT00264537|141769645|SUPERIORITY_OR_OTHER|||||||0.339||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.339
71133272|NCT00264537|141769646|SUPERIORITY_OR_OTHER|||||||0.006||||||If this test is significant, a pairwise comparison between Group 3 and Group 1, and between Group 4 and Group 1 will be performed|ANOVA|A 2-sided ANOVA on the van der Waerden normal scores with 1 factor: screening CRP (\< 1.5 mg/dL; ≥ 1.5 mg/dL)||Null Hypothesis: No difference in vdH-S score comparing Groups 1 vs Groups 3 and 4 combined. The sample size of 150 subjects in each treatment group (Group 1, Group 3, Group 4) will provide \> 95% power to detect a difference in the vdH-S score between treatment groups using a 2-sided t-test on van der Waerden normal scores of change from baseline in vdH-S score at α = 0.05, assuming a mean change from baseline in vdH-S score of 3.5 for the placebo group and 1 for Groups 3 and 4.||||0.006
71133273|NCT00264537|141769646|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANOVA|A 2-sided ANOVA on the van der Waerden normal scores with 1 factor: screening CRP (\< 1.5 mg/dL; \>= 1.5 mg/dL)||Null hypothesis: No difference in vdH-S score comparing Groups 1 vs 3.||||0.015
71133274|NCT00264537|141769646|SUPERIORITY_OR_OTHER|||||||0.025|||||||ANOVA|A 2-sided ANOVA on the van der Waerden normal scores with 1 factor: screening CRP (\< 1.5 mg/dL; \>= 1.5 mg/dL)||Null hypothesis: No difference in vdH-S score comparing Groups 1 vs 4.||||0.025
71133275|NCT00264537|141769647|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANOVA|2-sided ANOVA on the van der Waerden normal scores||||||0.003
71133276|NCT00264537|141769647|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANOVA|2-sided ANOVA on the van der Waerden normal scores||||||0.010
71133277|NCT00264537|141769647|SUPERIORITY_OR_OTHER|||||||0.014|||||||ANOVA|2-sided ANOVA on the van der Waerden normal scores||||||0.014
71133278|NCT00264537|141769647|SUPERIORITY_OR_OTHER|||||||0.545|||||||ANOVA|2-sided ANOVA on the van der Waerden normal scores||||||0.545
71133279|NCT03228212|141769650|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|5.1|STANDARD_DEVIATION|2.0|||TWO_SIDED|95.0|1.16|9.09|||Bayesian multivariate normal random-effe|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test - Control|It was calculated that 60 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect a 5 points difference in mean overall comfort at the 2-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05).||9.09|1.16|
70861148|NCT02169284|141208780|OTHER|||||||0.427|||||||Wilcoxon rank-sum test|||Membrane P-EGFR in Tumor Tissue, p-value between placebo and Erlotinib||||0.427
71133280|NCT03228212|141769651|NON_INFERIORITY|A non-inferiority margin of 0.05 logmar was used. This margin corresponds to a half line difference.|Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|0.00621|||TWO_SIDED|95.0|0.01|0.03|||Bayesian multivariate normal random-effe|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test - Control|It was calculated that 40 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect a 0.05 difference in LogMAR visual acuity at the 2-week follow-up. Sample size was determined using simulations methods for repeated measures.||0.03|0.01|
71133281|NCT03228212|141769652|NON_INFERIORITY|A non-inferiority margin of 90% was used. Lower limit of 95% credible interval was compared to 90%|proportion|0.992|||||TWO_SIDED|95.0|0.96|1.0|||Bayesian Methods|Bayesian Methods-Jefferys prior for binomial proportion was used to calculate 95% credible interval.||It was calculated that 70 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect a the 2-week follow-up. Sample size was determined using simulations methods for repeated measures. Analysis was only performed on eyes wearing the Tesl lens.||1|0.96|
71133282|NCT03228212|141769653|NON_INFERIORITY|A non-inferiority margin of 5% was used. Upper limit of the 95% credible interval was compared to 5%|Mean Difference (Final Values)|-0.0043|STANDARD_DEVIATION|0.0089|||TWO_SIDED|95.0|-0.0237|0.0129|||Bayesian beta-binomial model|Bayesian beta-binomial model for correlated binary data|Mean difference calculated as Test - Control|It was calculated that 120 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect 5% difference between the Test and Control lens with respect to the proportion of eyes with Grade 3 or higher slit lamp findings across all study visits. Sample size was determined using simulations methods. Sample size for this study was primarily driven by the slit lamp findings.||0.0129|-0.0237|
71133283|NCT03228212|141769654|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|7.2|STANDARD_DEVIATION|1.8|||TWO_SIDED|95.0|3.69|10.74|||Bayesian multivariate normal random-effe|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test - Control|Sample size calculations were based on the primary endpoints.||10.74|3.69|
71133284|NCT03228212|141769655|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|3.3|STANDARD_DEVIATION|1.5|||TWO_SIDED|95.0|0.36|6.29|||Bayesian multivariate normal random-effe|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test - Control|Sample size calculations were based on the primary endpoints.||6.29|0.36|
71133285|NCT01807299|141769656|OTHER||Mean Difference (Final Values)|5.0||||0.05|ONE_SIDED|5.0|||||Chi-squared, Corrected|||||||0.05
71133286|NCT01938040|141769672|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||ANOVA|||||||0.001
71133287|NCT00999544|141769680|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||"Area-under-the-curve (AUC) scores were derived from time course data and analyzed using two-factor ANOVA \[aprepitant dose (3 levels)x oxycodone dose (3 levels)\].~All analyses were conducted using SAS 9.1 for Windows (SAS Institute Inc., Cary, NC, USA) and were considered significant when P 0.05."||||<.05
70947720|NCT02725528|141396265|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
70947721|NCT02725528|141396266|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
71133288|NCT00806988|141769722|OTHER|An intention-to-treat analysis using a two-tailed Wilcoxon rank-sum test, at a 0.05 alpha level was used. This analysis accommodated missing LVESVI outcomes owing to death by assigning deceased patients the worst ranks in order according to the time of death. In the case of data that were missing for reasons other than death, we used multiple imputation to calculate the 12-month LVESVI on the assumption that the data were missing at random.||||||0.61|||||||Wilcoxon (Mann-Whitney)|||The primary null hypothesis was that there would be no significant between-group difference in the LVESVI at 12 months.||||0.61
71133289|NCT00806988|141769723|OTHER|||||||0.83|||||||Chi-squared|||||||0.83
71133290|NCT01525615|141769731|SUPERIORITY_OR_OTHER||Treatment ratio|1.138|STANDARD_ERROR_OF_MEAN|0.063||0.0209|TWO_SIDED|95.0|1.02|1.269||Mixed effects Model for Repeated Measures (MMRM) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time), log10 (baseline endurance time) by test day interaction, and patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and placebo. This treatment comparison is the first one in the alpha-protected hierarchical testing chain.||1.269|1.020|0.0209
71133291|NCT01525615|141769731|SUPERIORITY_OR_OTHER||Treatment ratio|1.086|STANDARD_ERROR_OF_MEAN|0.061||0.1419|TWO_SIDED|95.0|0.973|1.213||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 2.5/5.0 and placebo. This treatment comparison is the second one in the alpha-protected hierarchical testing chain. Since the p-value for this treatment comparison is \>0.05, the hierarchical testing chain is broken and all of the following hypothesis tests in this hierarchical chain are considered as descriptive only.||1.213|0.973|0.1419
71133292|NCT01525615|141769731|SUPERIORITY_OR_OTHER||Treatment ratio|1.047|STANDARD_ERROR_OF_MEAN|0.057||0.397|TWO_SIDED|95.0|0.941|1.166||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and Tio+Olo 2.5/5.0. This treatment comparison is not included in the alpha-protected hierarchical testing chain.||1.166|0.941|0.3970
71133293|NCT01525615|141769732|SUPERIORITY_OR_OTHER||Tretament ratio|1.209|STANDARD_ERROR_OF_MEAN|0.119||0.0552|TWO_SIDED|95.0|0.996|1.467||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and placebo. Since the hierarchical testing chain has been broken, even though this treatment comparison is included as the 3rd one in the alpha-protected hierarchical testing chain, this hypothesis test is descriptive only.||1.467|0.996|0.0552
71133294|NCT01525615|141769732|SUPERIORITY_OR_OTHER||Treatment ratio|1.211|STANDARD_ERROR_OF_MEAN|0.121||0.0562|TWO_SIDED|95.0|0.995|1.475||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean, 95% confidence limits transformed from log10 to original scale. SE was calculated using the delta method. This hypothesis test is descriptive.||Treatment ratio between Tio+Olo 2.5/5.0 and placebo||1.475|0.995|0.0562
71133295|NCT01525615|141769732|SUPERIORITY_OR_OTHER||Treatment ratio|0.998|STANDARD_ERROR_OF_MEAN|0.095||0.9822|TWO_SIDED|95.0|0.826|1.205||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and Tio+Olo 2.5/5.0. This treatment comparison is not included in the alpha-protected hierarchical testing chain.||1.205|0.826|0.9822
71133296|NCT01525615|141769733|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.234|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001|TWO_SIDED|95.0|0.133|0.336||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|This hypothesis test is descriptive.|LSMean=Least square mean.|||0.336|0.133|<0.0001
71133297|NCT01525615|141769733|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.207|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001|TWO_SIDED|95.0|0.105|0.309||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|This hypothesis test is descriptive.||||0.309|0.105|<0.0001
71133298|NCT01525615|141769733|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.027|STANDARD_ERROR_OF_MEAN|0.05||0.5892|TWO_SIDED|95.0|-0.072|0.126||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|This hypothesis test is descriptive.||||0.126|-0.072|0.5892
71133299|NCT01525615|141769734|SUPERIORITY_OR_OTHER||Treatment ratio|1.126|STANDARD_ERROR_OF_MEAN|0.059||0.0245|TWO_SIDED|95.0|1.015|1.248||ANCOVA model for log10 (endurance time \[s\]) with categorical effects of treatment and (log10-transformed) baseline as continuous covariate.|ANCOVA|This hypothesis test is descriptive.||Treatment ratio between Tio+Olo 5.0/5.0 and placebo||1.248|1.015|0.0245
71133300|NCT01525615|141769734|SUPERIORITY_OR_OTHER||Treatment ratio|1.103|STANDARD_ERROR_OF_MEAN|0.058||0.0655|TWO_SIDED|95.0|0.994|1.223|||ANCOVA|Descriptive||Treatment ratio between Tio+Olo 2.5/5.0 and placebo||1.223|0.994|0.0655
71133301|NCT01525615|141769734|SUPERIORITY_OR_OTHER||Treatment ratio|1.021|STANDARD_ERROR_OF_MEAN|0.053||0.6912|TWO_SIDED|95.0|0.921|1.132|||ANCOVA|Descriptive||Treatment ratio between Tio+Olo 5.0/5.0 and Tio+Olo 2.5/5.0||1.132|0.921|0.6912
71133302|NCT01525615|141769735|SUPERIORITY_OR_OTHER||Treatment ratio|1.229|STANDARD_ERROR_OF_MEAN|0.068||0.0002|TWO_SIDED|95.0|1.103|1.37||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and placebo. Hypothesis test is descriptive||1.370|1.103|0.0002
71133303|NCT01525615|141769735|SUPERIORITY_OR_OTHER||Treatment ratio|1.221|STANDARD_ERROR_OF_MEAN|0.068||0.0004|TWO_SIDED|95.0|1.095|1.362||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 2.5/5.0 and placebo. Hypothesis test is descriptive.||1.362|1.095|0.0004
71133304|NCT01525615|141769735|SUPERIORITY_OR_OTHER||Treatment ratio|1.006|STANDARD_ERROR_OF_MEAN|0.055||0.9062|TWO_SIDED|95.0|0.905|1.12||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and Tio+Olo 2.5/5.0. Hypothesis test is descriptive.||1.12|0.905|0.9062
71133305|NCT01525615|141769736|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.165|STANDARD_ERROR_OF_MEAN|0.058||0.0049|TWO_SIDED|95.0|0.051|0.279||ANCOVA model for inspiratory capacity (liters) with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive||||0.279|0.051|0.0049
71133306|NCT01525615|141769736|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.202|STANDARD_ERROR_OF_MEAN|0.058||0.0006|TWO_SIDED|95.0|0.088|0.316||ANCOVA model for inspiratory capacity (liters) with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive||||0.316|0.088|0.0006
71133307|NCT01525615|141769736|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.037|STANDARD_ERROR_OF_MEAN|0.058||0.5162|TWO_SIDED|95.0|-0.151|0.076||ANCOVA model for inspiratory capacity (liters) with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive||||0.076|-0.151|0.5162
71133308|NCT01525615|141769737|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.225|STANDARD_ERROR_OF_MEAN|0.051|<|0.0001|TWO_SIDED|95.0|0.124|0.326||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.326|0.124|<0.0001
71133309|NCT01525615|141769737|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.187|STANDARD_ERROR_OF_MEAN|0.052||0.0003|TWO_SIDED|95.0|0.086|0.288||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.288|0.086|0.0003
70861149|NCT02169284|141208780|OTHER|||||||0.416|||||||Wilcoxon rank-sum test|||Entire Cell P-EGFR in Tumor Tissue, p-value between placebo and Erlotinib||||0.416
71133310|NCT01525615|141769737|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.038|STANDARD_ERROR_OF_MEAN|0.05||0.4541|TWO_SIDED|95.0|-0.061|0.137||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.137|-0.061|0.4541
71133311|NCT01525615|141769738|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.002|STANDARD_ERROR_OF_MEAN|0.001||0.0468|TWO_SIDED|95.0|-0.004|0.0||ANCOVA model for mean slope of the intensity of breathing discomfort with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive||||-0.000|-0.004|0.0468
71133312|NCT01525615|141769738|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.002|STANDARD_ERROR_OF_MEAN|0.001||0.018|TWO_SIDED|95.0|-0.005|0.0||ANCOVA model for mean slope of the intensity of breathing discomfort with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive||||-0.000|-0.005|0.0180
71133313|NCT01525615|141769738|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.6856|TWO_SIDED|95.0|-0.002|0.002||ANCOVA model for mean slope of the intensity of breathing discomfort with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive||||0.002|-0.002|0.6856
71133314|NCT01525615|141769739|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.003|STANDARD_ERROR_OF_MEAN|0.001||0.0081|TWO_SIDED|95.0|-0.005|-0.001||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||-0.001|-0.005|0.0081
71133315|NCT01525615|141769739|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.003|STANDARD_ERROR_OF_MEAN|0.001||0.0099|TWO_SIDED|95.0|-0.005|-0.001||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||-0.001|-0.005|0.0099
70861150|NCT02169284|141208781|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Baseline visit - p-value between erlotinib and placebo arms||||1.000
70861151|NCT02169284|141208781|OTHER|||||||0.199|||||||Wilcoxon rank-sum test|||Day 8 - p-value between erlotinib and placebo arms||||0.199
70861152|NCT02169284|141208781|OTHER||||||<|0.001|||||||Wilcoxon rank-sum test|||Surgery visit - p-value between erlotinib and placebo arms||||<0.001
70947722|NCT02725528|141396267|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
70947723|NCT02725528|141396268|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
71133316|NCT01525615|141769739|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.9626|TWO_SIDED|95.0|-0.002|0.002||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.002|-0.002|0.9626
71133317|NCT01525615|141769740|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.002|STANDARD_ERROR_OF_MEAN|0.001||0.0598|TWO_SIDED|95.0|-0.004|0.0||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.000|-0.004|0.0598
71133318|NCT01525615|141769740|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.003|STANDARD_ERROR_OF_MEAN|0.001||0.0218|TWO_SIDED|95.0|-0.005|0.0||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||-0.000|-0.005|0.0218
71133319|NCT01525615|141769740|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.6549|TWO_SIDED|95.0|-0.002|0.003||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.003|-0.002|0.6549
71133320|NCT01525615|141769741|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.17|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.116|0.224||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.224|0.116|<0.0001
71133321|NCT01525615|141769741|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.184|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.129|0.239||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.239|0.129|<0.0001
71133322|NCT01525615|141769741|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.014|STANDARD_ERROR_OF_MEAN|0.027||0.6105|TWO_SIDED|95.0|-0.067|0.04||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.040|-0.067|0.6105
71133323|NCT01525615|141769742|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.246|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.192|0.3||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.300|0.192|<0.0001
71133324|NCT01525615|141769742|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.273|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.218|0.328||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.328|0.218|<0.0001
71133325|NCT01525615|141769742|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.027|STANDARD_ERROR_OF_MEAN|0.027||0.3236|TWO_SIDED|95.0|-0.08|0.027||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.027|-0.080|0.3236
71133326|NCT01525615|141769743|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.251|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.196|0.305||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.305|0.196|<0.0001
71133327|NCT01525615|141769743|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.257|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.202|0.312||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.312|0.202|<0.0001
70861153|NCT02169284|141208782|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Baseline visit - p-value between erlotinib and placebo arms||||1.000
70861154|NCT02169284|141208782|OTHER|||||||0.288|||||||Wilcoxon rank-sum test|||Day 8 - p-value between erlotinib and placebo arms||||0.288
70861155|NCT02169284|141208782|OTHER||||||<|0.001|||||||Wilcoxon rank-sum test|||Surgery visit - p-value between erlotinib and placebo arms||||<0.001
70861156|NCT02169284|141208783|OTHER|||||||0.792|||||||Wilcoxon rank-sum test|||P-value between groups at Baseline||||0.792
70861157|NCT02169284|141208783|OTHER|||||||0.261|||||||Wilcoxon rank-sum test|||P-value between groups at surgery visit||||0.261
70861158|NCT02169284|141208784|OTHER|||||||0.721|||||||Wilcoxon rank-sum test|||Expression of e-cadherin in Benign Tissue, P-Value between arms||||0.721
70947724|NCT02725528|141396269|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
71133328|NCT01525615|141769743|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.006|STANDARD_ERROR_OF_MEAN|0.027||0.8156|TWO_SIDED|95.0|-0.06|0.047||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.047|-0.060|0.8156
70861159|NCT02169284|141208784|OTHER|||||||0.108|||||||Wilcoxon rank-sum test|||Expression of e-cadherin in Tumor Tissue, P-Value between arms||||0.108
70861160|NCT02169284|141208785|OTHER|||||||0.444|||||||Wilcoxon rank-sum test|||Expression of KI-67 in Benign Tissue, P-Value between arms||||0.444
70861161|NCT02169284|141208785|OTHER|||||||0.663|||||||Wilcoxon rank-sum test|||Expression of KI-67 in Tumor Tissue, P-Value between arms||||0.663
70861162|NCT02169284|141208786|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Difference in p-ERK between Normal and Tumor Tissue, P-Value between arms||||1.000
70861163|NCT02169284|141208786|OTHER|||||||0.792|||||||Wilcoxon rank-sum test|||Difference in Cytoplasm p-ERK between Normal and Tumor Tissue, P-Value between arms||||0.792
70861164|NCT02169284|141208786|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Difference in Entire Cell p-ERK between Normal and Tumor Tissue, p-value between arms||||1.000
70861165|NCT02169284|141208787|OTHER|||||||0.772|||||||Wilcoxon rank-sum test|||||||0.772
70861166|NCT03583073|141208795|SUPERIORITY|||||||0.053|||||||Chi-squared, Corrected|DF = 1||||||.053
70861167|NCT03583073|141208796|SUPERIORITY||Mean Difference (Final Values)|1.94||||0.072|TWO_SIDED|95.0|-0.18|4.06|||Chi-squared, Corrected|||||4.06|-0.18|.072
70861168|NCT01367119|141208797|SUPERIORITY_OR_OTHER|||||||0.171||95.0|||||t-test, 2 sided|||P-values take into account variability across treatments and within subject.||||0.171
71133329|NCT04775953|141769799|SUPERIORITY|For participants with the same DOOR, quality-of-life (QoL) was used as a tiebreaker and was calculated as change from baseline QoL to Day 70 QoL score, as assessed by questions from the PROMIS physical function item bank (PROMIS Item Bank v2.0, short form 6b) on the Antibacterial Resistance Leadership Group (ARLG) Bloodstream Infection QoL Measure. Superiority of dalbavancin is concluded if the lower bound of the 95% confidence interval for the DOOR probability is greater than 50%.|Pr(Better DOOR in dalbavancin arm)|47.7|||||TWO_SIDED|95.0|39.84|55.68|||||The DOOR probability is calculated using the Wilcoxon-Mann-Whitney statistic corrected for ties.|Null Hypothesis: Probability that a participant in the dalbavancin arm has a better DOOR than a participant in the standard of care arm plus one-half the probability of equal DOOR is 50% (i.e., no difference in DOOR).||55.68|39.84|
71133330|NCT04775953|141769800|NON_INFERIORITY|The non-inferiority margin is -20%. Non-inferiority of dalbavancin is concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical efficacy is greater than -20%.|Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-12.0|14.0|||||Difference in proportions of clinical efficacy for dalbavancin compared to standard of care and 95% confidence interval obtained from a linear regression model.|Null Hypothesis: The proportion of clinical efficacy in the dalbavancin arm minus the proportion of clinical efficacy in the standard of care arm is -20%.||14|-12|
71133331|NCT02451943|141769820|SUPERIORITY||Hazard Ratio (HR)|1.047||||0.6945|TWO_SIDED|95.0|0.841|1.303|||Log Rank|Stratified||||1.303|0.841|0.6945
71133332|NCT02451943|141769821|SUPERIORITY||Hazard Ratio (HR)|0.951||||0.7618|TWO_SIDED|95.0|0.69|1.312|||Log Rank|Stratified||||1.312|0.690|0.7618
71133333|NCT02451943|141769822|SUPERIORITY||Hazard Ratio (HR)|1.231||||0.0422|TWO_SIDED|95.0|1.009|1.502|||Log Rank|Stratified||||1.502|1.009|0.0422
71133334|NCT02451943|141769828|SUPERIORITY||Hazard Ratio (HR)|0.616||||0.0934|TWO_SIDED|95.0|0.347|1.093|||Log Rank|Stratified||||1.093|0.347|0.0934
71133335|NCT02451943|141769829|SUPERIORITY||Hazard Ratio (HR)|1.123||||0.3347|TWO_SIDED|95.0|0.892|1.413|||Log Rank|Stratified||||1.413|0.892|0.3347
71133336|NCT00555880|141769838|SUPERIORITY_OR_OTHER_LEGACY||Sign Statistic|3.0||||0.146|TWO_SIDED||||||Sign test||Sign test was performed per analysis plan.|||||0.1460
71133337|NCT00555880|141769839|SUPERIORITY_OR_OTHER_LEGACY||Sign statistic|2.5||||0.2266|TWO_SIDED||||||Sign test||Sign test was performed per analysis plan.|||||0.2266
70861169|NCT01367119|141208798|SUPERIORITY_OR_OTHER|||||||0.258||95.0|||||t-test, 2 sided|||P-values take into account variability across treatments and within subject.||||0.258
70861170|NCT01367119|141208799|SUPERIORITY_OR_OTHER|||||||0.091||95.0|||||t-test, 2 sided|||Comparison between groups for nausea||||0.091
70861171|NCT01367119|141208799|SUPERIORITY_OR_OTHER|||||||0.763||95.0|||||t-test, 2 sided|||Comparison between groups for headache||||0.763
70861172|NCT01367119|141208799|SUPERIORITY_OR_OTHER|||||||0.356||95.0|||||t-test, 2 sided|||Comparison between groups for myalgia||||0.356
70861173|NCT01367119|141208799|SUPERIORITY_OR_OTHER|||||||0.093||95.0|||||t-test, 2 sided|||Comparison between groups for visual disturbance||||0.093
70861174|NCT01367119|141208799|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||Comparison between groups for confusion||||0.003
70861175|NCT01367119|141208799|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||t-test, 2 sided|||Comparison between groups for recovery room agitation||||0.860
70861176|NCT03180684|141208809|SUPERIORITY|||||||0.0071|||||||Clopper Pearson|A 1-sided p-value was calculated to prove superiority over historical control of 2%. Superiority of VGX-3100 alone was declared if p-value is \<0.025.||||||0.0071
70947725|NCT02725528|141396270|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
70947726|NCT02725528|141396271|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
70947727|NCT02635386|141396285|SUPERIORITY||||||<|0.02|||||||ANOVA|nested repeated measure||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.02
71133338|NCT00555880|141769840|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|97.9||||0.0418|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period and treatment as fixed effects, and subject within sequence as a random effect|ANOVA||Least squares mean for treatment difference (Midodrine HCL-Placebo)|Analysis of treatment difference||||0.0418
71133339|NCT00555880|141769841|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|91.1||||0.1928|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a one-way ANOVA model|ANOVA||Least squares mean for treatment difference (Midodrine HCL-Placebo)|||||0.1928
71133340|NCT00555880|141769842|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9479|TWO_SIDED|||||The P-value is from a 2-sample t-test for difference in mean|t-test, 2 sided|||||||0.9479
71133341|NCT00555880|141769843|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-5.7||||0.059|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA||Least squares mean for treatment difference (Midodrine HCl - Placebo)|Analysis of treatment||||0.0590
71133342|NCT00555880|141769844|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0633|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Dizziness, Lightheadedness, and Feeling Faint-Analysis of treatment||||0.0633
71133343|NCT00555880|141769844|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0191|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Problems with Vision-Analysis of treatment||||0.0191
71133344|NCT00555880|141769844|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0727|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Weakness-Analysis of treatment||||0.0727
71133345|NCT00555880|141769844|SUPERIORITY_OR_OTHER_LEGACY|||||||0.282|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Fatigue-Analysis of treatment||||0.2820
71133346|NCT00555880|141769844|SUPERIORITY_OR_OTHER_LEGACY|||||||0.088|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Trouble Concentrating-Analysis of treatment||||0.0880
71133347|NCT00555880|141769844|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6439|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Head/Neck Discomfort-Analysis of treatment||||0.6439
71133348|NCT00555880|141769847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0378|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Final systolic pressure-Analysis of treatment||||0.0378
71133349|NCT00555880|141769847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0108|TWO_SIDED||||||ANOVA|||Final diastolic pressure-Analysis of treatment||||0.0108
71133350|NCT00555880|141769849|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|92.4||||0.0296|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA||Least squares mean for treatment difference (Midodrine HCl - Placebo)|Analysis of treatment difference||||0.0296
71133351|NCT00555880|141769854|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0342|TWO_SIDED||||||Signed Rank Test|||Analysis of treatment||||0.0342
71133352|NCT01290757|141769856|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Scaled average BE is rejected, if the calculated upper 95% confidence limit of the linearized criterion is positive.|Upper 95% CI of the linearized criterion|-0.082|||||ONE_SIDED|95.0|||||Mixed Models Analysis||Linearized regulatory criterion according to Tothfalusi et al (Pharmaceutical Research, 2001). The square of the difference in treatment responses divided by within-subject variance of the reference formulation minus square of ln(1.25)/0.25|Capsugel minus Qualicaps||||
71133353|NCT01290757|141769856|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|126.33||||||90.0|119.45|133.6|||Mixed Models Analysis|||Capsugel vs Qualicaps||133.60|119.45|
71133354|NCT01290757|141769857|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Scaled average BE is rejected, if the calculated upper 95% confidence limit of the linearized criterion is positive.|Upper 95% CI of the linearized criterion|-0.085|||||ONE_SIDED|95.0|||||Mixed Models Analysis||Linearized regulatory criterion according to Tothfalusi et al (Pharmaceutical Research, 2001). The square of the difference in treatment responses divided by within-subject variance of the reference formulation minus square of ln(1.25)/0.25|Capsugel minus Qualicaps||||
71133355|NCT01290757|141769857|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|125.49||||||90.0|118.69|132.67|||Mixed Models Analysis|||Capsugel vs Qualicaps||132.67|118.69|
71133356|NCT01290757|141769858|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|124.74||||||90.0|118.32|131.51|||Mixed Models Analysis|||Capsugel vs Qualicaps||131.51|118.32|
71133357|NCT01290757|141769859|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|126.22||||||90.0|119.36|133.47|||Mixed Models Analysis|||Capsugel vs Qualicaps||133.47|119.36|
71133358|NCT01290757|141769860|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|125.3||||||90.0|118.42|132.59|||Mixed Models Analysis|||Capsugel vs Qualicaps||132.59|118.42|
71133359|NCT01290757|141769861|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|124.49||||||90.0|118.11|131.21|||Mixed Models Analysis|||Capsugel vs Qualicaps||131.21|118.11|
71133360|NCT00887549|141769862|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.015|||<|0.0001|TWO_SIDED|95.0|1.008|1.021|||Regression, Cox|The Cox model, based upon participant level data, included PFS as dependent variable and TS score in the nucleus as independent variable.||||1.021|1.008|<0.0001
71133361|NCT00759161|141769866|SUPERIORITY_OR_OTHER||||||<|0.001|||||||2-sided sign test|||||||< 0.001
71133362|NCT00479336|141769872|SUPERIORITY_OR_OTHER||Slope|-0.021|STANDARD_ERROR_OF_MEAN|0.02||0.3167|TWO_SIDED|95.0|-0.061|0.02|||Regression, Linear|||A linear regression model using change in body weight from baseline at the final timepoint as the criterion variable and dose as the explanatory variable was fitted to the dataset. The null hypothesis of whether the regression coefficient is zero (analysis using t-statistics) was tested at a two-tailed significance level of 0.05, and estimated values for the slope and 95% confidence interval were calculated.||0.020|-0.061|0.3167
71133363|NCT04112303|141769885|SUPERIORITY||||||<|0.001|||||||2-sided exact 1-sample binomial test|||The SVR12 rate was compared to the pre-specified efficacy threshold of 78% using a 2-sided exact 1-sample binomial test at the 0.05 significance level.||||<0.001
71133364|NCT04209205|141769959|SUPERIORITY||Marginal difference|25.02|||<|0.0001|TWO_SIDED|95.0|17.61|32.43|||Regression, Logistic|||||32.43|17.61|<.0001
71133365|NCT04209205|141769960|SUPERIORITY||Marginal difference|30.59|||<|0.0001|TWO_SIDED|95.0|21.14|40.05|||Regression, Logistic|||||40.05|21.14|<.0001
71133366|NCT04209205|141769961|SUPERIORITY||Marginal difference|17.17|||<|0.0001|TWO_SIDED|95.0|10.48|23.85|||Regression, Logistic|||||23.85|10.48|<.0001
71133367|NCT04209205|141769962|SUPERIORITY||Marginal difference|41.39|||<|0.0001|TWO_SIDED|95.0|30.64|52.13|||Regression, Logistic|||||52.13|30.64|<.0001
71133368|NCT04209205|141769963|SUPERIORITY||Least squares mean|-1.13|STANDARD_ERROR_OF_MEAN|0.129|<|0.0001|TWO_SIDED|95.0|-1.38|0.87|||Mixed Models Analysis|||||0.87|-1.38|<.0001
71133369|NCT04209205|141769964|SUPERIORITY||Least squares mean|-0.24|STANDARD_ERROR_OF_MEAN|-0.043|<|0.0001|TWO_SIDED|95.0|-0.32|0.15|||Mixed Models Analysis|||||0.15|-0.32|<.0001
71133370|NCT04209205|141769965|SUPERIORITY||Least squares mean|4.13|STANDARD_ERROR_OF_MEAN|0.676|<|0.0001|TWO_SIDED|95.0|2.8|5.46|||Mixed Models Analysis|||||5.46|2.80|<.0001
71133371|NCT04209205|141769966|SUPERIORITY||Least squares mean|2.85|STANDARD_ERROR_OF_MEAN|0.933||0.0024|TWO_SIDED|95.0|1.01|4.68|||Mixed Models Analysis|||||4.68|1.01|0.0024
71133372|NCT04209205|141769967|SUPERIORITY||Least squares mean|-6.11|STANDARD_ERROR_OF_MEAN|1.447|<|0.0001|TWO_SIDED|95.0|-8.96|-3.26|||Mixed Models Analysis|||||-3.26|-8.96|<.0001
71133373|NCT04209205|141769968|SUPERIORITY||Marginal difference|27.49||||0.0003|TWO_SIDED|95.0|12.43|42.55|||Regression, Logistic|||||42.55|12.43|0.0003
71133374|NCT04209205|141769969|SUPERIORITY||Marginal difference|16.35||||0.0102|TWO_SIDED|95.0|3.88|28.82|||Regression, Logistic|||||28.82|3.88|0.0102
71133375|NCT05236257|141769973|OTHER||Hazard Ratio (HR)|0.21||||0.0058|TWO_SIDED|95.0|0.07|0.63|||Cox Proportional Hazards model|Unweighted||||0.63|0.07|0.0058
71133376|NCT05236257|141769973|OTHER|||||||0.0023|||||||Log Rank|Unweighted||||||0.0023
71133377|NCT05236257|141769974|OTHER||Hazard Ratio (HR)|0.23||||0.0703|TWO_SIDED|95.0|0.05|1.13|||Cox Proportional Hazards model|Unweighted||||1.13|0.05|0.0703
71133378|NCT05236257|141769974|OTHER|||||||0.0486|||||||Log Rank|Unweighted||||||0.0486
71133379|NCT05236257|141769975|OTHER||Hazard Ratio (HR)|0.23||||0.696|TWO_SIDED|95.0|0.05|1.12|||Cox Proportional Hazards model|Unweighted||||1.12|0.05|0.696
71133380|NCT05236257|141769975|OTHER|||||||0.0476|||||||Log Rank|Unweighted||||||0.0476
71133381|NCT05236257|141769977|OTHER||Hazard Ratio (HR)|0.79||||0.5713|TWO_SIDED|95.0|0.36|1.77|||Cox Proportional Hazards model|Unweighted||||1.77|0.36|0.5713
71133382|NCT05236257|141769977|OTHER|||||||0.5695|||||||Log Rank|Unweighted||||||0.5695
71133383|NCT05236257|141769978|OTHER||Hazard Ratio (HR)|0.32||||0.32|TWO_SIDED|95.0|0.03|3.06|||Cox Proportional Hazards model|Unweighted||||3.06|0.03|0.3200
71133384|NCT05236257|141769978|OTHER|||||||0.294|||||||Log Rank|Unweighted||||||0.2940
71133385|NCT03071393|141769982|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71133386|NCT03071393|141769983|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71133387|NCT03071393|141769984|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71133388|NCT03071393|141769985|SUPERIORITY||||||<|0.05||||||Uncorrected p values are reported.|Wilcoxon (Mann-Whitney)|||||||<0.05
71133389|NCT03559933|141769991|SUPERIORITY||Logistic regression model|95.0|STANDARD_ERROR_OF_MEAN|0.0152||0.0125|TWO_SIDED|95.0|93.15|96.66|||Mixed Models Analysis|Subject and stimulation within subject as random effects with multiple observations per subject was accounted for.||The proportion of successful capture was analyzed using a generalized linear mixed model accounting for subject and stimulation within subject as random effects with multiple observations per subject. The null hypothesis was tested comparing the lower bound of the 98.75% two-sided confidence interval for the estimated percent diaphragm capture rate to the performance goal of 80%. If the lower bound was greater than 80%, the null hypothesis was rejected, and the endpoint was considered met.||96.66|93.15|0.0125
71133390|NCT01746225|141769996|SUPERIORITY|||||||0.12||||||Not adjusted for multiple comparisons; One-sided .05 alpha-level test|Log Rank|One-sided test||For each arm separately, PFS was compared to the historic PFS of first-line docetaxel using a one-sample one-sided log-rank test, of the null hypothesis, H0: median PFS≤7 months vs. H1: median PFS\>7 months.||||0.12
70947728|NCT02635386|141396286|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
70947729|NCT02635386|141396287|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
71133391|NCT01746225|141769996|SUPERIORITY|||||||0.03||||||Not adjusted for multiple comparisons; One-sided .05 alpha-level test|Log Rank|One-sided test||For each arm separately, PFS was compared to the historic PFS of first-line docetaxel using a one-sample one-sided log-rank test, of the null hypothesis, H0: median PFS≤7 months vs. H1: median PFS\>7 months.||||.03
71133392|NCT01746225|141769996|SUPERIORITY|||||||0.2||||||Not adjusted for multiple comparisons; One-sided .05 alpha-level test|Log Rank|One-sided test||For each arm separately, PFS was compared to the historic PFS of first-line docetaxel using a one-sample one-sided log-rank test, of the null hypothesis, H0: median PFS≤7 months vs. H1: median PFS\>7 months.||||.20
71133393|NCT02451514|141770043|OTHER||Geometric mean ratio|1.48|||||TWO_SIDED|95.0|1.03|2.12|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.||2.12|1.03|
71133394|NCT02451514|141770043|OTHER||Geometric mean ratio|0.93|||||TWO_SIDED|95.0|0.67|1.28|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.||1.28|0.67|
71133395|NCT02451514|141770043|OTHER||Geometric mean ratio|1.38|||||TWO_SIDED|95.0|0.97|1.96|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.||1.96|0.97|
71133396|NCT02451514|141770043|OTHER||Geometric mean ratio|1.98|||||TWO_SIDED|95.0|1.27|3.09|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.||3.09|1.27|
71133397|NCT02451514|141770043|OTHER||Geometric mean ratio|0.93|||||TWO_SIDED|95.0|0.63|1.37|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.||1.37|0.63|
71133398|NCT02451514|141770043|OTHER||Geometric mean ratio|1.84|||||TWO_SIDED|95.0|1.2|2.84|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.||2.84|1.20|
71133399|NCT02451514|141770043|OTHER||Geometric mean ratio|1.34|||||TWO_SIDED|95.0|0.96|1.85|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.||1.85|0.96|
71133400|NCT02451514|141770043|OTHER||Geometric mean ratio|0.94|||||TWO_SIDED|95.0|0.7|1.25|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.||1.25|0.70|
70947730|NCT02635386|141396288|SUPERIORITY||||||<|0.0001|||||||ANOVA|one way with Bonferroni contrast||One way ANOVA with Bonferroni test to compare differences between groups if significant||||<0.0001
70947731|NCT02635386|141396289|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
71133401|NCT02451514|141770043|OTHER||Geometric mean ratio|1.25|||||TWO_SIDED|95.0|0.91|1.72|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.||1.72|0.91|
71133402|NCT02451514|141770043|OTHER||Geometric mean ratio|1.43|||||TWO_SIDED|95.0|0.81|2.53|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.||2.53|0.81|
71133403|NCT02451514|141770043|OTHER||Geometric mean ratio|0.82|||||TWO_SIDED|95.0|0.49|1.37|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.||1.37|0.49|
71133404|NCT02451514|141770043|OTHER||Geometric mean ratio|1.18|||||TWO_SIDED|95.0|0.67|2.06|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.||2.06|0.67|
71133405|NCT02451514|141770043|OTHER||Geometric mean ratio|1.92|||||TWO_SIDED|95.0|1.33|2.78|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.||2.78|1.33|
71133406|NCT02451514|141770043|OTHER||Geometric mean ratio|0.84|||||TWO_SIDED|95.0|0.61|1.17|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.||1.17|0.61|
71133407|NCT02451514|141770043|OTHER||Geometric mean ratio|1.62|||||TWO_SIDED|95.0|1.13|2.32|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.||2.32|1.13|
71133408|NCT02451514|141770043|OTHER||Geometric mean ratio|7.15|||||TWO_SIDED|95.0|4.25|12.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.||12|4.25|
71133409|NCT02451514|141770043|OTHER||Geometric mean ratio|0.94|||||TWO_SIDED|95.0|0.59|1.5|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.||1.50|0.59|
71133410|NCT02451514|141770043|OTHER||Geometric mean ratio|6.73|||||TWO_SIDED|95.0|4.03|11.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.||11|4.03|
71133411|NCT02451514|141770043|OTHER||Geometric mean ratio|0.61|||||TWO_SIDED|95.0|0.3|1.23|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.||1.23|0.30|
71133412|NCT02451514|141770043|OTHER||Geometric mean ratio|5.53|||||TWO_SIDED|95.0|2.96|10.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.||10|2.96|
71133413|NCT02451514|141770043|OTHER||Geometric mean ratio|3.38|||||TWO_SIDED|95.0|1.7|6.73|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.||6.73|1.70|
71133414|NCT02451514|141770043|OTHER||Geometric mean ratio|2.58|||||TWO_SIDED|95.0|1.2|5.54|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.||5.54|1.20|
71133415|NCT02451514|141770043|OTHER||Geometric mean ratio|1.3|||||TWO_SIDED|95.0|0.66|2.56|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.||2.56|0.66|
71133416|NCT02451514|141770043|OTHER||Geometric mean ratio|3.34|||||TWO_SIDED|95.0|1.57|7.11|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.||7.11|1.57|
71133417|NCT02451514|141770043|OTHER||Geometric mean ratio|1.14|||||TWO_SIDED|95.0|0.51|2.59|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.||2.59|0.51|
71133418|NCT02451514|141770043|OTHER||Geometric mean ratio|2.93|||||TWO_SIDED|95.0|1.4|6.12|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.||6.12|1.40|
70861177|NCT03180684|141208809|SUPERIORITY|||||||0.0004|||||||Clopper Pearson|1-sided p-value was calculated to prove superiority over historical control of 2%.Superiority of VGX-3100+imiquimod was declared if p-value is \<0.025.||||||0.0004
71133419|NCT02451514|141770043|OTHER||Geometric mean ratio|3.35|||||TWO_SIDED|95.0|1.49|7.57|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.||7.57|1.49|
71133420|NCT02451514|141770043|OTHER||Geometric mean ratio|0.52|||||TWO_SIDED|95.0|0.23|1.18|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.||1.18|0.23|
71133421|NCT02451514|141770043|OTHER||Geometric mean ratio|5.94|||||TWO_SIDED|95.0|2.84|12.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.||12|2.84|
71133422|NCT02451514|141770043|OTHER||Geometric mean ratio|3.09|||||TWO_SIDED|95.0|1.38|6.92|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.||6.92|1.38|
71133423|NCT02451514|141770047|OTHER||Geometric mean ratio|8.5|||||TWO_SIDED|95.0|4.41|16.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.||16|4.41|
71133424|NCT02451514|141770047|OTHER||Geometric mean ratio|0.7|||||TWO_SIDED|95.0|0.39|1.27|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.||1.27|0.39|
71133425|NCT02451514|141770047|OTHER||Geometric mean ratio|5.97|||||TWO_SIDED|95.0|3.14|11.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.||11|3.14|
71133426|NCT02451514|141770047|OTHER||Geometric mean ratio|197.0|||||TWO_SIDED|95.0|86.0|452.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.||452|86|
71133427|NCT02451514|141770047|OTHER||Geometric mean ratio|0.98|||||TWO_SIDED|95.0|0.47|2.07|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.||2.07|0.47|
71133428|NCT02451514|141770047|OTHER||Geometric mean ratio|193.0|||||TWO_SIDED|95.0|84.0|442.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.||442|84|
71133429|NCT02451514|141770047|OTHER||Geometric mean ratio|3.51|||||TWO_SIDED|95.0|1.96|6.27|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.||6.27|1.96|
71133430|NCT02451514|141770047|OTHER||Geometric mean ratio|0.62|||||TWO_SIDED|95.0|0.37|1.0|||Mixed Models Analysis|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.||1.0|0.37|
71133431|NCT02451514|141770047|OTHER||Geometric mean ratio|2.17|||||TWO_SIDED|95.0|1.23|3.85|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.||3.85|1.23|
71133432|NCT02451514|141770047|OTHER||Geometric mean ratio|3.57|||||TWO_SIDED|95.0|1.84|6.92|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.||6.92|1.84|
71133433|NCT02451514|141770047|OTHER||Geometric mean ratio|0.72|||||TWO_SIDED|95.0|0.4|1.29|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.||1.29|0.40|
71133434|NCT02451514|141770047|OTHER||Geometric mean ratio|2.55|||||TWO_SIDED|95.0|1.33|4.89|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.||4.89|1.33|
71133435|NCT02451514|141770047|OTHER||Geometric mean ratio|17.0|||||TWO_SIDED|95.0|8.18|35.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.||35|8.18|
71133436|NCT02451514|141770047|OTHER||Geometric mean ratio|0.8|||||TWO_SIDED|95.0|0.41|1.53|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.||1.53|0.41|
71133437|NCT02451514|141770047|OTHER||Geometric mean ratio|13.0|||||TWO_SIDED|95.0|6.59|28.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.||28|6.59|
71133438|NCT02451514|141770047|OTHER||Geometric mean ratio|74.0|||||TWO_SIDED|95.0|34.0|160.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.||160|34|
71133439|NCT02451514|141770047|OTHER||Geometric mean ratio|0.77|||||TWO_SIDED|95.0|0.38|1.53|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.||1.53|0.38|
71133440|NCT02451514|141770047|OTHER||Geometric mean ratio|57.0|||||TWO_SIDED|95.0|27.0|121.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.||121|27|
70872123|NCT02155608|141229495|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|Group: F = .05, df = 1/59||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.83
70872124|NCT02155608|141229495|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|Time: F = 4.52, df = 1/43||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.04
71133441|NCT02451514|141770047|OTHER||Geometric mean ratio|2.66|||||TWO_SIDED|95.0|1.46|4.83|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.||4.83|1.46|
71133442|NCT02451514|141770047|OTHER||Geometric mean ratio|6.76|||||TWO_SIDED|95.0|3.96|12.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.||12|3.96|
71133443|NCT02451514|141770047|OTHER||Geometric mean ratio|18.0|||||TWO_SIDED|95.0|10.0|32.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.||32|10|
71133444|NCT02451514|141770047|OTHER||Geometric mean ratio|1.4|||||TWO_SIDED|95.0|0.72|2.71|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.||2.71|0.72|
71133445|NCT02451514|141770047|OTHER||Geometric mean ratio|21.0|||||TWO_SIDED|95.0|12.0|37.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.||37|12|
71133446|NCT02451514|141770047|OTHER||Geometric mean ratio|29.0|||||TWO_SIDED|95.0|15.0|55.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.||55|15|
71133447|NCT02451514|141770047|OTHER||Geometric mean ratio|0.81|||||TWO_SIDED|95.0|0.47|1.38|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.||1.38|0.47|
71133448|NCT02451514|141770047|OTHER||Geometric mean ratio|19.0|||||TWO_SIDED|95.0|12.0|31.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.||31|12|
71133449|NCT02451514|141770047|OTHER||Geometric mean ratio|16.0|||||TWO_SIDED|95.0|9.27|26.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.||26|9.27|
71133450|NCT02451514|141770047|OTHER||Geometric mean ratio|0.46|||||TWO_SIDED|95.0|0.17|1.28|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.||1.28|0.17|
71133451|NCT02451514|141770047|OTHER||Geometric mean ratio|20.0|||||TWO_SIDED|95.0|8.2|48.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.||48|8.20|
71133452|NCT02451514|141770047|OTHER||Geometric mean ratio|9.13|||||TWO_SIDED|95.0|3.78|22.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.||22|3.78|
71133453|NCT02451514|141770060|OTHER||Geometric mean ratio|0.49|||||TWO_SIDED|95.0|0.28|0.87|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis Serogroup B, M14459||0.87|0.28|
71133454|NCT02451514|141770060|OTHER||Geometric mean ratio|0.91|||||TWO_SIDED|95.0|0.4|2.11|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis Serogroup B, M01-0240364||2.11|0.40|
70861178|NCT03475875|141208829|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|1.73|||TWO_SIDED|95.0|-7.7|-0.9|||Linear Mixed Model|Kenward and Roger Method was used for the Degrees of Freedom|Mean difference was calculated as Test - Control|It was calculated that 80 participants randomized in a 1:1 fashion between the two sequences would have at least 90% power to detect a 5 points difference in mean overall comfort at the 2-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05).||-0.9|-7.7|
70947732|NCT02635386|141396290|SUPERIORITY||||||<|0.05|||||||ANOVA|Nested repeated measure design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.05
70947733|NCT02635386|141396291|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
70872125|NCT02155608|141229495|SUPERIORITY|||||||0.73|||||||Mixed Models Analysis|Group \* time: F = .12, df = 1/43||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.73
70947734|NCT02635386|141396292|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
70947735|NCT02635386|141396293|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
70947736|NCT02635386|141396294|SUPERIORITY||||||<|0.01|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.01
70872126|NCT02155608|141229496|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|Group: F = 1.62, df = 1/58.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parametrized in the model as a standard linear viable, time (ranging from baseline to 4 weeks) and a second variable, time2. defined as 0 at baseline and time past week 1 for subsequent weeks. The time 2 coefficient represents the change in slope after the initial week.||||.21
70861179|NCT03475875|141208830|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|1.43|||TWO_SIDED|95.0|-4.7|1.0|||Linear Mixed Model|Kenward and Roger Method was used for the Degrees of Freedom|Mean difference was calculated as Test - Control|It was calculated that 80 participants randomized in a 1:1 fashion between the two sequences would have at least 90% power to detect a 5 points difference in mean overall comfort at the 2-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05).||1.0|-4.7|
70861180|NCT02017171|141208831|SUPERIORITY||Mean Difference (Final Values)|0.001||||0.999|TWO_SIDED|95.0|-1.9|1.9||p value is not adjusted for multiple comparisons, a priori threshold for statistical significance: p\<0.05|linear model for correlated errors||Treatment difference = Allopurinol-Placebo|||1.9|-1.9|0.999
71133455|NCT02451514|141770060|OTHER||Geometric mean ratio|0.83|||||TWO_SIDED|95.0|0.5|1.38|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup B, NZ98/254||1.38|0.50|
71133456|NCT02451514|141770060|OTHER||Geometric mean ratio|0.79|||||TWO_SIDED|95.0|0.44|1.44|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup B, M10713||1.44|0.44|
71133457|NCT02451514|141770060|OTHER||Geometric mean ratio|0.6|||||TWO_SIDED|95.0|0.34|1.07|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup B, H44/76||1.07|0.34|
71133458|NCT02451514|141770060|OTHER||Geometric mean ratio|0.77|||||TWO_SIDED|95.0|0.52|1.12|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup B, 5/99||1.12|0.52|
71133459|NCT02451514|141770060|OTHER||Geometric mean ratio|2.99|||||TWO_SIDED|95.0|1.89|4.75|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup A||4.75|1.89|
71133460|NCT02451514|141770060|OTHER||Geometric mean ratio|4.69|||||TWO_SIDED|95.0|3.01|7.31|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup C||7.31|3.01|
70861181|NCT02017171|141208832|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-1.6|2.2||For secondary outcomes, 95% confidence intervals are reported, without P values. The confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||Treatment difference = Allopurinol - Placebo|||2.2|-1.6|
70861182|NCT02017171|141208833|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-1.7|2.3||For secondary outcomes, 95% confidence intervals are reported, without P values. The confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||Treatment difference = Allopurinol - Placebo|||2.3|-1.7|
70861183|NCT02017171|141208834|SUPERIORITY||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-1.5|0.4||For secondary outcomes, 95% confidence intervals are reported, without P values.|||Treatment difference = Allopurinol - Placebo. Confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||0.4|-1.5|
71133461|NCT02451514|141770060|OTHER||Geometric mean ratio|8.6|||||TWO_SIDED|95.0|5.84|13.0|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup W||13|5.84|
71133462|NCT02451514|141770060|OTHER||Geometric mean ratio|7.03|||||TWO_SIDED|95.0|3.96|12.0|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup Y||12|3.96|
71133463|NCT03197376|141770069|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for each serotype 1, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 1 GMC Ratio|0.96|||||TWO_SIDED|95.0|0.88|1.05||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.05|0.88|
70861184|NCT02017171|141208835|SUPERIORITY||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-1.0|0.5||For secondary outcomes, 95% confidence intervals are reported, without P values.|||Treatment difference = Allopurinol - Placebo. Confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||0.5|-1.0|
70861185|NCT02017171|141208836|SUPERIORITY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.5|2.9||For secondary outcomes, 95% confidence intervals are reported, without P values.|||Hazard ratio = Allopurinol / Placebo. Confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||2.9|0.5|
70861186|NCT02017171|141208837|SUPERIORITY||Ratio (Final Values)|1.4|||||TWO_SIDED|95.0|1.0|1.8||For secondary outcomes, 95% confidence intervals are reported, without P values.|||Ratio = Allopurinol / Placebo. Confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||1.8|1.0|
70861187|NCT02017171|141208838|SUPERIORITY||Ratio (Final Values)|1.3|||||TWO_SIDED|95.0|1.0|1.6||For secondary outcomes, 95% confidence intervals are reported, without P values.|||||Ratio = Allopurinol / Placebo. Confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|1.6|1.0|
70861188|NCT02017171|141208839|SUPERIORITY||Hazard Ratio (HR)|1.9|||||TWO_SIDED|95.0|0.8|4.5||For secondary outcomes, 95% confidence intervals are reported, without P values.|||Hazard Ratio = Allopurinol / Placebo. Confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||4.5|0.8|
70861189|NCT03091777|141208852|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||||||<0.001
70861190|NCT03091777|141208852|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||||||<0.001
70861191|NCT02536833|141208853|SUPERIORITY||Mean Difference (Final Values)|-1.46||||0.575|TWO_SIDED|95.0|-6.57|3.65|||ANCOVA|||||3.65|-6.57|0.575
70861192|NCT02536833|141208853|SUPERIORITY||Mean Difference (Final Values)|-1.27||||0.643|TWO_SIDED|95.0|-6.63|4.09|||ANCOVA|||||4.09|-6.63|0.643
70861193|NCT02536833|141208853|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.901|TWO_SIDED|95.0|-5.07|5.75|||ANCOVA|||||5.75|-5.07|0.901
70861194|NCT02536833|141208854|SUPERIORITY||Mean Difference (Final Values)|-2.99||||0.271|TWO_SIDED|95.0|-8.31|2.33|||ANCOVA|||||2.33|-8.31|0.271
70861195|NCT02536833|141208854|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.898|TWO_SIDED|95.0|-6.06|5.32|||ANCOVA|||||5.32|-6.06|0.898
70861196|NCT02536833|141208854|SUPERIORITY||Mean Difference (Final Values)|0.72||||0.795|TWO_SIDED|95.0|-4.74|6.18|||ANCOVA|||||6.18|-4.74|0.795
70947737|NCT02635386|141396295|SUPERIORITY||||||<|0.035|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.035
71133464|NCT03197376|141770069|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 5, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 5 GMC Ratio|0.75|||||TWO_SIDED|95.0|0.69|0.81||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.81|0.69|
71133465|NCT03197376|141770069|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6A, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6A GMC Ratio|1.1|||||TWO_SIDED|95.0|0.96|1.26||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.26|0.96|
71133466|NCT03197376|141770069|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6B, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6B GMC Ratio|1.41|||||TWO_SIDED|95.0|1.18|1.69||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.69|1.18|
70861197|NCT02536833|141208855|SUPERIORITY||Mean Difference (Final Values)|-2.74||||0.283|TWO_SIDED|95.0|-7.74|2.26|||ANCOVA|||||2.26|-7.74|0.283
70861198|NCT02536833|141208855|SUPERIORITY||Mean Difference (Final Values)|-1.48||||0.588|TWO_SIDED|95.0|-6.82|3.86|||ANCOVA|||||3.86|-6.82|0.588
70861199|NCT02536833|141208855|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.853|TWO_SIDED|95.0|-5.76|4.76|||ANCOVA|||||4.76|-5.76|0.853
70861200|NCT02536833|141208856|SUPERIORITY||Mean Difference (Final Values)|-2.89||||0.292|TWO_SIDED|95.0|-8.26|2.49|||ANCOVA|||||2.49|-8.26|0.292
70861201|NCT02536833|141208856|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.931|TWO_SIDED|95.0|-5.34|5.83|||ANCOVA|||||5.83|-5.34|0.931
70861202|NCT02536833|141208856|SUPERIORITY||Mean Difference (Final Values)|0.42||||0.878|TWO_SIDED|95.0|-4.92|5.76|||ANCOVA|||||5.76|-4.92|0.878
70861203|NCT02536833|141208857|SUPERIORITY||Mean Difference (Final Values)|1.16||||0.648|TWO_SIDED|95.0|-3.83|6.16|||ANCOVA|||||6.16|-3.83|0.648
70861204|NCT02536833|141208857|SUPERIORITY||Mean Difference (Final Values)|-3.14||||0.209|TWO_SIDED|95.0|-8.02|1.75|||ANCOVA|||||1.75|-8.02|0.209
70861205|NCT02536833|141208857|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.915|TWO_SIDED|95.0|-4.78|5.33|||ANCOVA|||||5.33|-4.78|0.915
70861206|NCT02536833|141208858|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.969|TWO_SIDED|95.0|-5.16|5.36|||ANCOVA|||||5.36|-5.16|0.969
70861207|NCT02536833|141208858|SUPERIORITY||Mean Difference (Final Values)|-3.64||||0.174|TWO_SIDED|95.0|-8.89|1.61|||ANCOVA|||||1.61|-8.89|0.174
70861208|NCT02536833|141208858|SUPERIORITY||Mean Difference (Final Values)|0.31||||0.908|TWO_SIDED|95.0|-4.97|5.59|||ANCOVA|||||5.59|-4.97|0.908
70861209|NCT02536833|141208859|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.334|TWO_SIDED|95.0|-0.1|0.29|||ANCOVA|||||0.29|-0.10|0.334
70861210|NCT02536833|141208859|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.124|TWO_SIDED|95.0|-0.04|0.3|||ANCOVA|||||0.30|-0.04|0.124
70861211|NCT02536833|141208859|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.032|TWO_SIDED|95.0|0.02|0.36|||ANCOVA|||||0.36|0.02|0.032
70861212|NCT02536833|141208860|SUPERIORITY||Mean Difference (Final Values)|-2.38||||0.405|TWO_SIDED|95.0|-8.0|3.24|||ANCOVA|||||3.24|-8.00|0.405
70947738|NCT02635386|141396296|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
71133467|NCT03197376|141770069|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 7F, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 7F GMC Ratio|1.09|||||TWO_SIDED|95.0|0.99|1.2||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.20|0.99|
71133468|NCT03197376|141770069|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 9V, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 9V GMC Ratio|1.08|||||TWO_SIDED|95.0|0.98|1.18||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.18|0.98|
71133469|NCT03197376|141770069|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 14, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 14 GMC Ratio|0.93|||||TWO_SIDED|95.0|0.81|1.07||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.07|0.81|
71133470|NCT03197376|141770069|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19A, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19A GMC Ratio|0.93|||||TWO_SIDED|95.0|0.83|1.04||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.04|0.83|
71133471|NCT03197376|141770069|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19F, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19F GMC Ratio|0.84|||||TWO_SIDED|95.0|0.76|0.92||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.92|0.76|
71133472|NCT03197376|141770069|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 23F, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 23F GMC Ratio|1.02|||||TWO_SIDED|95.0|0.91|1.15||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.15|0.91|
71133473|NCT03197376|141770069|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 1, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 1 GMC Ratio|0.89|||||TWO_SIDED|95.0|0.82|0.97||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.97|0.82|
71133474|NCT03197376|141770069|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 5, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 5 GMC Ratio|0.73|||||TWO_SIDED|95.0|0.67|0.8||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2||0.80|0.67|
71133475|NCT03197376|141770069|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6A, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6A GMC Ratio|1.04|||||TWO_SIDED|95.0|0.91|1.2||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2||1.20|0.91|
71133476|NCT03197376|141770069|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6B, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6B GMC Ratio|0.87|||||TWO_SIDED|95.0|0.74|1.04||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.04|0.74|
71133477|NCT03197376|141770069|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 7F, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 7F GMC Ratio|0.75|||||TWO_SIDED|95.0|0.68|0.83||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.83|0.68|
70861213|NCT02536833|141208860|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.552|TWO_SIDED|95.0|-4.37|8.16|||ANCOVA|||||8.16|-4.37|0.552
70947739|NCT02635386|141396297|SUPERIORITY||||||<|0.02|||||||ANOVA|nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.02
71133478|NCT03197376|141770069|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 9V, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 9V GMC Ratio|0.88|||||TWO_SIDED|95.0|0.8|0.97||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.97|0.80|
70947740|NCT02635386|141396298|SUPERIORITY||||||<|0.035|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.035
71133479|NCT03197376|141770069|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 14, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 14 GMC Ratio|0.95|||||TWO_SIDED|95.0|0.83|1.09||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.09|0.83|
71133480|NCT03197376|141770069|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19A, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19A GMC Ratio|0.88|||||TWO_SIDED|95.0|0.79|0.98||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.98|0.79|
71133481|NCT03197376|141770069|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19F, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19F GMC Ratio|1.08|||||TWO_SIDED|95.0|0.97|1.2||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.20|0.97|
71133482|NCT03197376|141770069|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 24F, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 23F GMC Ratio|1.03|||||TWO_SIDED|95.0|0.92|1.15||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.15|0.92|
71133483|NCT03197376|141770069|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 1, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 1 GMC Ratio|0.93|||||TWO_SIDED|95.0|0.85|1.01||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.01|0.85|
71133484|NCT03197376|141770069|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 5, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 5 GMC Ratio|0.98|||||TWO_SIDED|95.0|0.9|1.07||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.07|0.90|
71133485|NCT03197376|141770069|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6A, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6A GMC Ratio|0.95|||||TWO_SIDED|95.0|0.82|1.09||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.09|0.82|
71133486|NCT03197376|141770069|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6B, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6B GMC Ratio|0.62|||||TWO_SIDED|95.0|0.52|0.74||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.74|0.52|
71133487|NCT03197376|141770069|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 7F, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 7F GMC Ratio|0.69|||||TWO_SIDED|95.0|0.62|0.76||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.76|0.62|
70947741|NCT02635386|141396299|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
71133488|NCT03197376|141770069|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 9V, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 9V GMC Ratio|0.82|||||TWO_SIDED|95.0|0.74|0.9||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.90|0.74|
71133489|NCT03197376|141770069|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 14, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 14 GMC Ratio|1.02|||||TWO_SIDED|95.0|0.89|1.17||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.17|0.89|
70861214|NCT02536833|141208860|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.763|TWO_SIDED|95.0|-4.91|6.68|||ANCOVA|||||6.68|-4.91|0.763
70861215|NCT02536833|141208861|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.173|TWO_SIDED|95.0|-9.5|1.71|||ANCOVA|||||1.71|-9.50|0.173
70861216|NCT02536833|141208861|SUPERIORITY||Mean Difference (Final Values)|1.12||||0.724|TWO_SIDED|95.0|-5.12|7.36|||ANCOVA|||||7.36|-5.12|0.724
70861217|NCT02536833|141208861|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.914|TWO_SIDED|95.0|-6.17|5.53|||ANCOVA|||||5.53|-6.17|0.914
70947742|NCT02635386|141396300|SUPERIORITY||||||<|0.04|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.04
70947743|NCT02635386|141396301|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||>0.05
70947744|NCT02635386|141396302|SUPERIORITY||||||<|0.04|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.04
70947745|NCT02635386|141396303|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
70947746|NCT02635386|141396304|SUPERIORITY||||||<|0.05|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.05
70947747|NCT02635386|141396305|SUPERIORITY||||||<|0.001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.001
70861218|NCT02536833|141208862|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.529|TWO_SIDED|95.0|-0.12|0.24|||ANCOVA|||||0.24|-0.12|0.529
70861219|NCT02536833|141208862|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.259|TWO_SIDED|95.0|-0.08|0.28|||ANCOVA|||||0.28|-0.08|0.259
70861220|NCT02536833|141208862|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.807|TWO_SIDED|95.0|-0.21|0.16|||ANCOVA|||||0.16|-0.21|0.807
70861221|NCT02536833|141208863|SUPERIORITY||Mean Difference (Final Values)|-8.73||||0.049|TWO_SIDED|95.0|-17.44|-0.03|||ANCOVA|||||-0.03|-17.44|0.049
70861222|NCT02536833|141208863|SUPERIORITY||Mean Difference (Final Values)|-6.03||||0.211|TWO_SIDED|95.0|-15.49|3.43|||ANCOVA|||||3.43|-15.49|0.211
70861223|NCT02536833|141208863|SUPERIORITY||Mean Difference (Final Values)|-5.23||||0.254|TWO_SIDED|95.0|-14.24|3.78|||ANCOVA|||||3.78|-14.24|0.254
70861224|NCT02536833|141208864|SUPERIORITY||Mean Difference (Final Values)|-10.26||||0.036|TWO_SIDED|95.0|-19.82|-0.69|||ANCOVA|||||-0.69|-19.82|0.036
70861225|NCT02536833|141208864|SUPERIORITY||Mean Difference (Final Values)|-7.07||||0.17|TWO_SIDED|95.0|-17.18|3.05|||ANCOVA|||||3.05|-17.18|0.170
70861226|NCT02536833|141208864|SUPERIORITY||Mean Difference (Final Values)|-6.29||||0.171|TWO_SIDED|95.0|-15.33|2.74|||ANCOVA|||||2.74|-15.33|0.171
70861227|NCT02536833|141208865|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.021|TWO_SIDED|95.0|0.06|0.72|||ANCOVA|||||0.72|0.06|0.021
70861228|NCT02536833|141208865|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.131|TWO_SIDED|95.0|-0.07|0.55|||ANCOVA|||||0.55|-0.07|0.131
70861229|NCT02536833|141208865|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.789|TWO_SIDED|95.0|-0.35|0.26|||ANCOVA|||||0.26|-0.35|0.789
70861230|NCT05308290|141208928|OTHER|||||||0.6||||||the a priori threshold for statistical significance was \<0.05|t-test, 2 sided|||||||0.60
70861231|NCT05308290|141208929|OTHER|||||||0.6||||||the a priori threshold for statistical significance was \<0.05|t-test, 2 sided|||||||0.60
70861232|NCT05308290|141208930|OTHER|||||||1||||||the a priori threshold for statistical significance was \<0.05|Fisher Exact|||||||1.0
70861233|NCT05308290|141208931|OTHER|||||||1||||||the a priori threshold for statistical significance was \<0.05|Fisher Exact|||||||1.0
70861234|NCT05308290|141208932|OTHER|||||||0.28||||||the a priori threshold for statistical significance was \<0.05|Fisher Exact|||||||0.28
70861235|NCT04437368|141208939|SUPERIORITY||LS Mean Difference|0.291|STANDARD_ERROR_OF_MEAN|0.2838|||TWO_SIDED|90.0|-0.195|0.777|||mixed model repeated measures|||Week 12||0.777|-0.195|
70861236|NCT04437368|141208939|SUPERIORITY||LS Mean Difference|0.282|STANDARD_ERROR_OF_MEAN|0.2843|||TWO_SIDED|90.0|-0.206|0.769|||mixed model repeated measures|||Week 12||0.769|-0.206|
70947748|NCT02635386|141396306|SUPERIORITY||||||<|0.035|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.035
70947749|NCT02635386|141396307|SUPERIORITY||||||<|0.035|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.035
70947750|NCT01427738|141396365|SUPERIORITY_OR_OTHER||Difference in proportion with clinical e|0.044|||||TWO_SIDED|95.1|-0.077|0.166||||||Repeated confidence intervals (RCIs) were used to control type I error.A interim analysis was conducted by a 99.7% CI. The final analyses use a 95.1% CI, based on the Lan-DeMets error-spending function corresponding to the O'Brien-Fleming boundary.76% of 100 participant in arm GV had cure or improvement of OC after 14 days of treatment, and 71.6% of 102 in arm nystatin had cure or improvement of OC. Difference in clinical efficacy rates between GV and nystatin 95.1% CI is 0.044 (-0.077, 0.166).||0.166|-0.077|
70947751|NCT01214421|141396377|SUPERIORITY||Ratio of geometric means (final values)|0.99||||0.358|TWO_SIDED|95.0|0.96|1.02|||Mixed Models Analysis||||Derived from the least squares (LS) mean difference between the treatment groups at each visit using MMRM model with factors of treatment, visit, region, baseline, baseline hypertensive status, baseline renal volume status, baseline creatinine clearance status, interaction of treatment and visit, and interaction of baseline and visit.|1.02|0.96|0.358
71133490|NCT03197376|141770069|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19A, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19A GMC Ratio|0.95|||||TWO_SIDED|95.0|0.85|1.06||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.06|0.85|
71133491|NCT03197376|141770069|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19F, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19F GMC Ratio|1.29|||||TWO_SIDED|95.0|1.16|1.44||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.44|1.16|
71133492|NCT03197376|141770069|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 23F, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 23F GMC Ratio|1.0|||||TWO_SIDED|95.0|0.89|1.13||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.13|0.89|
71133493|NCT03197376|141770070|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10%, for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 1|0.7|||||TWO_SIDED|97.5|0.0|1.9||||||||1.9|-0.0|
70861237|NCT04437368|141208939|SUPERIORITY||LS Mean Difference|0.658|STANDARD_ERROR_OF_MEAN|0.373|||TWO_SIDED|90.0|0.017|1.299|||mixed model repeated measures|||Week 24||1.299|0.017|
71133494|NCT03197376|141770070|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 5|2.8|||||TWO_SIDED|97.5|1.2|5.0||||||||5.0|1.2|
71133495|NCT03197376|141770070|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 6A|5.2|||||TWO_SIDED|97.5|1.1|9.5||||||Synflorix proportion of responders for serotype 6A was operationally defined as the lowest observed proportion of responders among the 8 serotypes in common with PNEUMOSIL||9.5|1.1|
71133496|NCT03197376|141770070|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 6B|2.0|||||TWO_SIDED|97.5|-2.2|6.4||||||||6.4|-2.2|
71133497|NCT03197376|141770070|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 7F|1.0|||||TWO_SIDED|97.5|-0.1|2.7||||||||2.7|-0.1|
71133498|NCT03197376|141770070|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 9V|0.1|||||TWO_SIDED|97.5|-1.9|2.5||||||||2.5|-1.9|
71133499|NCT03197376|141770070|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 14|-0.3|||||TWO_SIDED|97.5|-1.4|1.0||||||||1.0|-1.4|
71133500|NCT03197376|141770070|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 19A|18.7|||||TWO_SIDED|97.5|15.1|22.5||||||Synflorix proportion of responders for serotype 19A was operationally defined as the lowest observed proportion of responders among the 8 serotypes in common with PNEUMOSIL||22.5|15.1|
71133501|NCT03197376|141770070|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 19F|-0.8|||||TWO_SIDED|97.5|-1.9|0.5||||||||0.5|-1.9|
71133502|NCT03197376|141770070|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 23F|17.2|||||TWO_SIDED|97.5|13.6|21.1||||||||21.1|13.6|
71133503|NCT03197376|141770071|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 1 GMC Ratio|2.15|||||TWO_SIDED|97.5|2.0|2.32||||||||2.32|2.00|
71133504|NCT03197376|141770071|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 5 GMC Ratio|1.37|||||TWO_SIDED|97.5|1.28|1.47||||||||1.47|1.28|
71133505|NCT03197376|141770071|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 6A GMC Ratio|0.89|||||TWO_SIDED|97.5|0.78|1.01||||||Synflorix proportion of responders for serotype 6A was operationally defined as the lowest observed proportion of responders among the 8 serotypes in common with PNEUMOSIL||1.01|0.78|
71133506|NCT03197376|141770071|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 6B GMC Ratio|1.07|||||TWO_SIDED|97.5|0.93|1.24||||||||1.24|0.93|
71133507|NCT03197376|141770071|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 7F GMC Ratio|1.3|||||TWO_SIDED|97.5|1.19|1.41||||||||1.41|1.19|
71133508|NCT03197376|141770071|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 9V GMC Ratio|0.92|||||TWO_SIDED|97.5|0.85|1.0||||||||1.00|0.85|
71133509|NCT03197376|141770071|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 14 GMC Ratio|1.23|||||TWO_SIDED|97.5|1.1|1.37||||||||1.37|1.10|
71133510|NCT03197376|141770071|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 19A GMC Ratio|1.45|||||TWO_SIDED|97.5|1.3|1.63||||||Synflorix proportion of responders for serotype 19A was operationally defined as the lowest observed proportion of responders among the 8 serotypes in common with PNEUMOSIL||1.63|1.30|
71133511|NCT03197376|141770071|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 19F GMC Ratio|0.73|||||TWO_SIDED|97.5|0.67|0.8||||||||0.80|0.67|
71133512|NCT03197376|141770071|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 23F GMC Ratio|1.81|||||TWO_SIDED|97.5|1.63|2.01||||||||2.01|1.63|
71133513|NCT03197376|141770072|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for diphtheria|0.0|||||TWO_SIDED||||||||CI could not be computed due to 100% response rate|||||
71133514|NCT03197376|141770072|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Tetanus|0.0|||||TWO_SIDED||||||||CI could not be computed due to 100% response rate|||||
71133515|NCT03197376|141770072|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Hepatitis B|0.4|||||TWO_SIDED|95.0|-0.4|2.5||||||||2.5|-0.4|
71133516|NCT03197376|141770072|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Hib|-0.9|||||TWO_SIDED|95.0|-2.5|1.2||||||||1.2|-2.5|
71133517|NCT03197376|141770072|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Polio type 1|-0.2|||||TWO_SIDED|95.0|-1.3|1.5||||||||1.5|-1.3|
71133518|NCT03197376|141770072|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Polio type 2|2.8|||||TWO_SIDED|95.0|-3.2|9.3||||||||9.3|-3.2|
71133519|NCT03197376|141770072|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Polio type 3|-0.9|||||TWO_SIDED|95.0|-3.0|1.8||||||||1.8|-3.0|
71133520|NCT03197376|141770072|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Rotavirus|0.2|||||TWO_SIDED|95.0|-7.1|7.1||||||||7.1|-7.1|
71133521|NCT03197376|141770073|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI for the GMC ratio exceeded 0.5 (for pertussis antigens).|GMC Ratio for anti-pertussis toxoid|0.82|||||TWO_SIDED|95.0|0.62|1.09||||||||1.09|0.62|
70861238|NCT04437368|141208939|SUPERIORITY||LS Mean Difference|0.84|STANDARD_ERROR_OF_MEAN|0.3791|||TWO_SIDED|90.0|0.189|1.49|||mixed model repeated measures|||Week 24||1.490|0.189|
71133522|NCT03197376|141770074|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI for the GMC ratio exceeded 0.5 (for pertussis antigens).|GMC Ratio for anti-fimbriae 2/3|0.98|||||TWO_SIDED|95.0|0.77|1.25||||||||1.25|0.77|
71133523|NCT03197376|141770081|SUPERIORITY|Proportions with IgG concentration ≥ 0.35 µg/mL will be compared using a z-test for proportions. The test will be done at the two-sided 2.5% significance level to adjust for the two superiority tests. 97.5% CIs for treatment-group differences in response, will also be reported|Difference for Type 6A|73.3|||||TWO_SIDED|97.5|69.8|76.3||||||||76.3|69.8|
71133524|NCT03197376|141770081|SUPERIORITY|Proportions with IgG concentration ≥ 0.35 µg/mL will be compared using a z-test for proportions. The test will be done at the two-sided 2.5% significance level to adjust for the two superiority tests. 97.5% CIs for treatment-group differences in response, will also be reported|Difference for Type 19A|54.7|||||TWO_SIDED|97.5|50.3|58.9||||||||58.9|50.3|
71133525|NCT03197376|141770082|SUPERIORITY|For each of the two serotypes, GMCs are compared by a two-sample t-test on the difference between means of log10 (antibody). The test was done at the two-sided 2.5% significance level to adjust for the two superiority tests. 97.5% CIs for treatment-group differences in response, are also be reported|Pn IgG type 6A GMC Ratio|8.51|||||TWO_SIDED|97.5|7.68|9.43||||||||9.43|7.68|
71133526|NCT03197376|141770082|SUPERIORITY|For each of the two serotypes, GMCs are compared by a two-sample t-test on the difference between means of log10 (antibody). The test was done at the two-sided 2.5% significance level to adjust for the two superiority tests. 97.5% CIs for treatment-group differences in response, are also be reported|Pn IgG type 19A GMC Ratio|5.64|||||TWO_SIDED|97.5|5.14|6.18||||||||6.18|5.14|
71133527|NCT03197376|141770083|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 1|17.2|||||TWO_SIDED|95.0|11.0|23.6||||||||23.6|11.0|
71133528|NCT03197376|141770083|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 5|2.8|||||TWO_SIDED|95.0|0.0|6.2||||||||6.2|-0.0|
71133529|NCT03197376|141770083|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 6A|82.2|||||TWO_SIDED|95.0|76.7|86.6||||||||86.6|76.7|
71133530|NCT03197376|141770083|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 6B|9.4|||||TWO_SIDED|95.0|4.5|14.6||||||||14.6|4.5|
71133531|NCT03197376|141770083|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 7F|0.4|||||TWO_SIDED|95.0|-1.1|2.2||||||||2.2|-1.1|
71133532|NCT03197376|141770083|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 9V|0.0|||||TWO_SIDED||||||||CI could not be computed due to 100% response rate|||||
71133533|NCT03197376|141770083|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type14|-0.8|||||TWO_SIDED|95.0|-4.0|2.2||||||||2.2|-4.0|
70861239|NCT04437368|141208939|SUPERIORITY||LS Mean Difference|0.668|STANDARD_ERROR_OF_MEAN|0.4954|||TWO_SIDED|90.0|-0.177|1.512|||mixed model repeated measures|||Week 36||1.512|-0.177|
71133534|NCT03197376|141770083|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 19A|53.3|||||TWO_SIDED|95.0|46.0|60.1||||||||60.1|46.0|
71133535|NCT03197376|141770083|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 19F|-1.6|||||TWO_SIDED|95.0|-4.9|1.2||||||||1.2|-4.9|
70861240|NCT04437368|141208939|SUPERIORITY||LS Mean Difference|0.912|STANDARD_ERROR_OF_MEAN|0.4887|||TWO_SIDED|90.0|0.078|1.746|||mixed model repeated measures|||Week 36||1.746|0.078|
70861241|NCT04437368|141208939|SUPERIORITY||LS Mean Difference|0.976|STANDARD_ERROR_OF_MEAN|0.4813|||TWO_SIDED|90.0|0.15|1.803|||mixed model repeated measures|||Week 48||1.803|0.150|
71133536|NCT03197376|141770083|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 23F|0.0|||||TWO_SIDED||||||||CI could not be computed due to 100% response rate|||||
71133537|NCT03197376|141770084|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 1|3.09|||||TWO_SIDED|95.0|2.4|3.98||||||||3.98|2.40|
71133538|NCT03197376|141770084|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 5|1.39|||||TWO_SIDED|95.0|1.12|1.72||||||||1.72|1.12|
71133539|NCT03197376|141770084|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 6A|186.0|||||TWO_SIDED|95.0|144.0|241.0||||||||241|144|
71133540|NCT03197376|141770084|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 6B|1.95|||||TWO_SIDED|95.0|1.42|2.69||||||||2.69|1.42|
70861242|NCT04437368|141208939|SUPERIORITY||LS Mean Difference|1.233|STANDARD_ERROR_OF_MEAN|0.4573|||TWO_SIDED|90.0|0.445|2.022|||mixed model repeated measures|||Week 48||2.022|0.445|
70861243|NCT04437368|141208940|SUPERIORITY||LS Mean Difference|1.769|STANDARD_ERROR_OF_MEAN|1.2808|||TWO_SIDED|90.0|-0.441|3.979|||mixed model repeated measures|||Week 72||3.979|-0.441|
70861244|NCT04437368|141208940|SUPERIORITY||LS Mean Difference|1.274|STANDARD_ERROR_OF_MEAN|1.2349|||TWO_SIDED|90.0|-0.863|3.412|||mixed model repeated measures|||Week 72||3.412|-0.863|
71133541|NCT03197376|141770084|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 7F|1.16|||||TWO_SIDED|95.0|0.96|1.39||||||||1.39|0.96|
71133542|NCT03197376|141770084|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 9V|0.38|||||TWO_SIDED|95.0|0.29|0.49||||||||0.49|0.29|
71133543|NCT03197376|141770084|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 14|0.92|||||TWO_SIDED|95.0|0.67|1.27||||||||1.27|0.67|
71133544|NCT03197376|141770084|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 19A|13.4|||||TWO_SIDED|95.0|10.2|17.7||||||||17.7|10.2|
71133545|NCT03197376|141770084|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 19F|0.66|||||TWO_SIDED|95.0|0.54|0.81||||||||0.81|0.54|
70861245|NCT04437368|141208940|SUPERIORITY||LS Mean Difference|2.041|STANDARD_ERROR_OF_MEAN|1.4177|||TWO_SIDED|90.0|-0.386|4.468|||mixed model repeated measures|||Week 96||4.468|-0.386|
70861246|NCT04437368|141208940|SUPERIORITY||LS Mean|1.278|STANDARD_ERROR_OF_MEAN|1.3857|||TWO_SIDED|90.0|-1.099|3.655|||mixed model repeated measures|||Week 96||3.655|-1.099|
71133546|NCT03197376|141770084|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 23F|3.03|||||TWO_SIDED|95.0|2.25|4.09||||||||4.09|2.25|
71133547|NCT03197376|141770085|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 1 GMC Ratio|1.41|||||TWO_SIDED|95.0|1.31|1.52||||||||1.52|1.31|
71133548|NCT03197376|141770085|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 5 GMC Ratio|0.88|||||TWO_SIDED|95.0|0.81|0.95||||||||0.95|0.81|
71133549|NCT03197376|141770085|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 6A GMC Ratio|4.46|||||TWO_SIDED|95.0|4.01|4.96||||||||4.96|4.01|
71133550|NCT03197376|141770085|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 6B GMC Ratio|6.43|||||TWO_SIDED|95.0|5.7|7.26||||||||7.26|5.70|
71133551|NCT03197376|141770085|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 7F GMC Ratio|2.04|||||TWO_SIDED|95.0|1.89|2.19||||||||2.19|1.89|
71133552|NCT03197376|141770085|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 9V GMC Ratio|1.39|||||TWO_SIDED|95.0|1.29|1.5||||||||1.50|1.29|
71133553|NCT03197376|141770085|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 14 GMC Ratio|1.35|||||TWO_SIDED|95.0|1.21|1.51||||||||1.51|1.21|
71133554|NCT03197376|141770085|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 19A GMC Ratio|2.64|||||TWO_SIDED|95.0|2.4|2.91||||||||2.91|2.40|
71133555|NCT03197376|141770085|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 19F GMC Ratio|1.49|||||TWO_SIDED|95.0|1.36|1.63||||||||1.63|1.36|
70861247|NCT04437368|141208946|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|5.49|||TWO_SIDED|90.0|-10.3|8.1|||mixed model repeated measures|||Week 12||8.1|-10.3|
70861248|NCT04437368|141208946|SUPERIORITY||LS Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|5.96|||TWO_SIDED|90.0|-16.3|3.7|||mixed model repeated measures|||Week 12||3.7|-16.3|
70861249|NCT04437368|141208946|SUPERIORITY||LS Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|5.54|||TWO_SIDED|90.0|-14.5|4.1|||mixed model repeated measures|||Week 24||4.1|-14.5|
70861250|NCT04437368|141208946|SUPERIORITY||LS Mean Difference|-11.7|STANDARD_ERROR_OF_MEAN|6.0|||TWO_SIDED|90.0|-21.7|-1.6|||mixed model repeated measures|||Week 24||-1.6|-21.7|
70861251|NCT04437368|141208946|SUPERIORITY||LS Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|5.63|||TWO_SIDED|90.0|-18.4|0.5|||mixed model repeated measures|||Week 36||0.5|-18.4|
70861252|NCT04437368|141208946|SUPERIORITY||LS Mean Difference|-11.9|STANDARD_ERROR_OF_MEAN|6.08|||TWO_SIDED|90.0|-22.1|-1.7|||mixed model repeated measures|||Week 36||-1.7|-22.1|
71133556|NCT03197376|141770085|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 23F GMC Ratio|2.5|||||TWO_SIDED|95.0|2.29|2.72||||||||2.72|2.29|
71133557|NCT03197376|141770085|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 1 GMC Ratio|1.17|||||TWO_SIDED|95.0|1.06|1.28||||||||1.28|1.06|
70861253|NCT04437368|141208946|SUPERIORITY||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|5.88|||TWO_SIDED|90.0|-12.7|6.9|||mixed model repeated measures|||Week 48||6.9|-12.7|
70861254|NCT04437368|141208946|SUPERIORITY||LS Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|6.14|||TWO_SIDED|90.0|-17.9|2.7|||mixed model repeated measures|||Week 48||2.7|-17.9|
70861255|NCT04437368|141208946|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|5.96|||TWO_SIDED|90.0|-7.4|12.5|||mixed model repeated measures|||Week 72||12.5|-7.4|
70861256|NCT04437368|141208946|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|6.18|||TWO_SIDED|90.0|-11.1|9.6|||mixed model repeated measures|||Week 72||9.6|-11.1|
70861257|NCT04437368|141208946|SUPERIORITY||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|6.07|||TWO_SIDED|90.0|-8.7|11.5|||mixed model repeated measures|||Week 96||11.5|-8.7|
70861258|NCT04437368|141208946|SUPERIORITY||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|6.47|||TWO_SIDED|90.0|-13.8|7.8|||mixed model repeated measures|||Week 96||7.8|-13.8|
70861259|NCT01231230|141208975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.0|||<|0.001|TWO_SIDED||||||ANOVA|||mean difference from baseline relative to placebo||||< 0.001
71133558|NCT03197376|141770085|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 5 GMC Ratio|0.67|||||TWO_SIDED|95.0|0.61|0.74||||||||0.74|0.61|
70861260|NCT01231230|141208975|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||mean difference from baseline relative to placebo||||<0.001
70861261|NCT01231230|141208975|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||mean difference from baseline relative to placebo||||>0.05
70861262|NCT04105543|141208984|OTHER|nonparametric rank test|Median Difference (Final Values)|-4.22||||0.173|TWO_SIDED|95.0|-12.64|4.24|||Wilcoxon Signed Rank Tests|||Wilcoxon Signed Rank Tests for MDADI Composite Baseline to 3 months (n=9)||4.24|-12.64|0.173
70861263|NCT04105543|141208984|OTHER|nonparametric rank test|Median Difference (Final Values)|-9.998||||0.225|TWO_SIDED|95.0|-28.43|7.39|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for MDADI Composite Baseline to 6 months (n=5)||7.39|-28.43|0.225
70861264|NCT04105543|141208985|OTHER|nonparametric rank test|Median Difference (Final Values)|-0.037||||0.779|TWO_SIDED|95.0|-0.246|0.09|||Wilcoxon Signed Rank Tests|||Wilcoxon Signed Rank Tests for Stimulated Saliva Flow Baseline to 3 months (n=8)||0.09|-0.246|0.779
71133559|NCT03197376|141770085|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 6A GMC Ratio|3.49|||||TWO_SIDED|95.0|2.97|4.11||||||||4.11|2.97|
71133560|NCT03197376|141770085|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 6B GMC Ratio|3.85|||||TWO_SIDED|95.0|3.23|4.59||||||||4.59|3.23|
71133561|NCT03197376|141770085|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 7F GMC Ratio|1.63|||||TWO_SIDED|95.0|1.47|1.82||||||||1.82|1.47|
71133562|NCT03197376|141770085|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 9V GMC Ratio|1.46|||||TWO_SIDED|95.0|1.31|1.62||||||||1.62|1.31|
70861265|NCT04105543|141208985|OTHER|nonparametric rank test|Median Difference (Final Values)|-0.049||||0.465|TWO_SIDED|95.0|-0.218|0.12|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for Stimulated Saliva Flow Baseline to 6 months (n=4)||0.12|-0.218|0.465
70861266|NCT04105543|141208986|OTHER|nonparametric rank test|Median Difference (Final Values)|-4.444||||0.213|TWO_SIDED|95.0|-14.4|4.4|||Wilcoxon Signed Rank Tests|||Wilcoxon Signed Rank Tests for EORTC QLQ-C30 Functional Score Baseline to 3 months (n=9)||4.4|-14.4|0.213
71133563|NCT03197376|141770085|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 14 GMC Ratio|1.21|||||TWO_SIDED|95.0|1.03|1.42||||||||1.42|1.03|
71133564|NCT03197376|141770085|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 19A GMC Ratio|3.6|||||TWO_SIDED|95.0|2.99|4.33||||||||4.33|2.99|
71133565|NCT03197376|141770085|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 19F GMC Ratio|1.55|||||TWO_SIDED|95.0|1.38|1.75||||||||1.75|1.38|
71133566|NCT03197376|141770085|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 23F GMC Ratio|2.29|||||TWO_SIDED|95.0|1.98|2.65||||||||2.65|1.98|
71133567|NCT03197376|141770086|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 1 GMC Ratio|2.34|||||TWO_SIDED|95.0|2.02|2.71||||||||2.71|2.02|
71133568|NCT03197376|141770086|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 5 GMC Ratio|1.57|||||TWO_SIDED|95.0|1.38|1.79||||||||1.79|1.38|
71133569|NCT03197376|141770086|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 6A GMC Ratio|11.6|||||TWO_SIDED|95.0|9.67|14.0||||||||14.0|9.67|
71133570|NCT03197376|141770086|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 6B GMC Ratio|1.89|||||TWO_SIDED|95.0|1.65|2.15||||||||2.15|1.65|
71133571|NCT03197376|141770086|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 7F GMC Ratio|1.57|||||TWO_SIDED|95.0|1.37|1.8||||||||1.80|1.37|
71133572|NCT03197376|141770086|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 9V GMC Ratio|0.87|||||TWO_SIDED|95.0|0.76|0.99||||||||0.99|0.76|
71133573|NCT03197376|141770086|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 14 GMC Ratio|1.48|||||TWO_SIDED|95.0|1.21|1.82||||||||1.82|1.21|
71133574|NCT03197376|141770086|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 19A GMC Ratio|4.22|||||TWO_SIDED|95.0|3.52|5.06||||||||5.06|3.52|
71133575|NCT03197376|141770086|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 19F GMC Ratio|0.63|||||TWO_SIDED|95.0|0.55|0.73||||||||0.73|0.55|
71133576|NCT03197376|141770086|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 23F GMC Ratio|1.91|||||TWO_SIDED|95.0|1.63|2.24||||||||2.24|1.63|
70861267|NCT04105543|141208986|OTHER|nonparametric rank test|Median Difference (Final Values)|-6.667||||0.686|TWO_SIDED|95.0|-17.8|20.0|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for EORTC QLQ-C30 Functional Scores Baseline to 6 months (n=5)||20|-17.8|0.686
70861268|NCT04105543|141208986|OTHER|nonparametric rank test|Median Difference (Final Values)|3.846||||0.498|TWO_SIDED|95.0|-0.769|12.82|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Tests for EORTC QLQ-C30 Symptom Score Baseline to 3 months (n=9)||12.82|-0.769|0.498
70861269|NCT04105543|141208986|OTHER|nonparametric rank test|Median Difference (Final Values)|10.256||||0.416|TWO_SIDED|95.0|-15.39|35.89|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for EORTC QLQ-C30 Symptom Scores Baseline to 6 months (n=5)||35.89|-15.39|0.416
70861270|NCT04105543|141208986|OTHER|nonparametric rank test|Median Difference (Final Values)|-8.33||||0.778|TWO_SIDED|95.0|-20.84|16.67|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Tests for EORTC QLQ-C30 Global Health Status Score Baseline to 3 months (n=9)||16.67|-20.84|0.778
70861271|NCT04105543|141208986|OTHER|nonparametric rank test|Median Difference (Final Values)|0.0||||0.89|TWO_SIDED|95.0|-25.0|25.0|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for EORTC QLQ-C30 Global Health Status Scores Baseline to 6 months (n=5)||25|-25|0.89
70861272|NCT04105543|141208987|OTHER|nonparametric rank test|Median Difference (Final Values)|3.5||||0.138|TWO_SIDED|95.0|-2.0|9.5|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Tests for XeQOL Baseline to 3 months (n=9)||9.5|-2|0.138
70861273|NCT04105543|141208987|OTHER|nonparametric rank test|Median Difference (Final Values)|6.0||||0.225|TWO_SIDED|95.0|-10.0|16.0|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for XeQOL Baseline to 6 months (n=5)||16|-10|0.225
70861274|NCT04105543|141208988|OTHER|nonparametric rank test|Median Difference (Final Values)|0.5||||0.674|TWO_SIDED|95.0|-3.0|5.0|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Tests for Xerostomia Inventory Baseline to 3 months (n=9)||5|-3|0.674
70947752|NCT01214421|141396378|SUPERIORITY||LS mean difference (final values)|3.15||||0.0003|TWO_SIDED|95.0|1.462|4.836|||Mixed Models Analysis||||Derived from MMRM analysis with fixed factors of treatment, visit, treatment visit interaction, hypertensive status, renal volume status and creatinine clearance status at baseline, region, baseline value, and baseline visit interaction as covariates, and with a heterogeneous toeplitz variance covariance matrix.|4.836|1.462|0.0003
70861275|NCT04105543|141208988|OTHER|nonparametric rank test|Median Difference (Final Values)|0.0||||0.892|TWO_SIDED|95.0|-6.0|6.0|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for Xerostomia Inventory Baseline to 6 months (n=5)||6|-6|0.892
70947753|NCT01214421|141396379|NON_INFERIORITY|The non-inferiority for early-treatment and delayed-treatment groups.|Ratio of geometric means (final values)|1.011||||0.0462|TWO_SIDED|95.0|1.0|1.023|||Mixed Models Analysis||||Derived from testing interaction of time and treatment using linear mixed model in which intercept and time are treated as random effects.|1.023|1.000|0.0462
70861276|NCT02393690|141208989|SUPERIORITY|||||||0.0787|||||||Fisher Exact|||||||0.0787
70861277|NCT02393690|141208990|SUPERIORITY|||||||0.0787|||||||Fisher Exact|||||||0.0787
70861278|NCT02393690|141208991|SUPERIORITY|||||||0.1764|||||||Log Rank|||||||0.1764
70861279|NCT02393690|141208992|SUPERIORITY|||||||0.0756|||||||Wilcoxon (Mann-Whitney)|||||||0.0756
70861280|NCT01298544|141209022|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.68|||||TWO_SIDED|95.0|0.48|0.94|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 4||0.94|0.48|
70861281|NCT01298544|141209022|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.81|||||TWO_SIDED|95.0|0.64|1.04|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 6B||1.04|0.64|
70861282|NCT01298544|141209022|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.95|||||TWO_SIDED|95.0|0.74|1.23|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 9V||1.23|0.74|
70861283|NCT01298544|141209022|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.67|||||TWO_SIDED|95.0|0.45|1.01|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 14||1.01|0.45|
70861284|NCT01298544|141209022|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.96|||||TWO_SIDED|95.0|0.7|1.31|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 18C||1.31|0.70|
70861285|NCT01298544|141209022|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.56|||||TWO_SIDED|95.0|0.4|0.77|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 19F||0.77|0.40|
70861286|NCT01298544|141209022|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.82|||||TWO_SIDED|95.0|0.64|1.05|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 23F||1.05|0.64|
70861287|NCT01298544|141209022|SUPERIORITY_OR_OTHER||Ratio of GMCs|1.97|||||TWO_SIDED|95.0|1.39|2.8|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 4||2.80|1.39|
70861288|NCT01298544|141209022|SUPERIORITY_OR_OTHER||Ratio of GMCs|3.04|||||TWO_SIDED|95.0|2.41|3.84|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 6B||3.84|2.41|
70861289|NCT01298544|141209022|SUPERIORITY_OR_OTHER||Ratio of GMCs|1.26|||||TWO_SIDED|95.0|0.98|1.62|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 9V||1.62|0.98|
70947754|NCT01214421|141396380|NON_INFERIORITY|The non-inferiority for early-treatment and delayed-treatment groups.|Ratio of geometric means (final values)|-0.113||||0.7259|TWO_SIDED|95.0|-0.746|0.52|||Mixed Models Analysis||||Derived from testing interaction of time and treatment using linear mixed model in which intercept and time are treated as random effects.|0.520|-0.746|0.7259
70861290|NCT01298544|141209022|SUPERIORITY_OR_OTHER||Ratio of GMCs|6.66|||||TWO_SIDED|95.0|4.53|9.79|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 14||9.79|4.53|
70861291|NCT01298544|141209022|SUPERIORITY_OR_OTHER||Ratio of GMCs|2.34|||||TWO_SIDED|95.0|1.68|3.24|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 18C||3.24|1.68|
70861292|NCT01298544|141209022|SUPERIORITY_OR_OTHER||Ratio of GMCs|4.47|||||TWO_SIDED|95.0|3.29|6.07|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 19F||6.07|3.29|
70861293|NCT01298544|141209022|SUPERIORITY_OR_OTHER||Ratio of GMCs|2.08|||||TWO_SIDED|95.0|1.65|2.63|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 23F||2.63|1.65|
70861294|NCT01298544|141209023|SUPERIORITY_OR_OTHER||Difference in proportions|-18.5|||||TWO_SIDED|95.0|-29.4|-7.3|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 4||-7.3|-29.4|
70861295|NCT01298544|141209023|SUPERIORITY_OR_OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-3.1|3.0|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 6B||3.0|-3.1|
70861296|NCT01298544|141209023|SUPERIORITY_OR_OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-5.9|7.3|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 9V||7.3|-5.9|
70861297|NCT01298544|141209023|SUPERIORITY_OR_OTHER||Difference in proportions|-3.4|||||TWO_SIDED|95.0|-10.3|3.1|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 14||3.1|-10.3|
70861298|NCT01298544|141209023|SUPERIORITY_OR_OTHER||Difference in proportions|-11.9|||||TWO_SIDED|95.0|-22.7|-1.0|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 18C||-1.0|-22.7|
70861299|NCT01298544|141209023|SUPERIORITY_OR_OTHER||Difference in proportions|-2.5|||||TWO_SIDED|95.0|-7.1|0.6|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 19F||0.6|-7.1|
70861300|NCT01298544|141209023|SUPERIORITY_OR_OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-4.5|2.3|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 23F||2.3|-4.5|
70861301|NCT01298544|141209023|SUPERIORITY_OR_OTHER||Difference in proportions|25.0|||||TWO_SIDED|95.0|12.7|37.0|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 4||37.0|12.7|
70861302|NCT01298544|141209023|SUPERIORITY_OR_OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-0.011|7.715|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 6B||7.715|-0.011|
70861303|NCT01298544|141209023|SUPERIORITY_OR_OTHER||Difference in proportions|10.3|||||TWO_SIDED|95.0|1.9|19.6|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 9V||19.6|1.9|
70861304|NCT01298544|141209023|SUPERIORITY_OR_OTHER||Difference in proportions|29.7|||||TWO_SIDED|95.0|19.4|40.5|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 14||40.5|19.4|
70861305|NCT01298544|141209023|SUPERIORITY_OR_OTHER||Difference in proportions|30.0|||||TWO_SIDED|95.0|17.9|41.5|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 18C||41.5|17.9|
70861306|NCT01298544|141209023|SUPERIORITY_OR_OTHER||Difference in proportions|6.5|||||TWO_SIDED|95.0|1.2|13.9|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 19F||13.9|1.2|
70861307|NCT01298544|141209023|SUPERIORITY_OR_OTHER||Difference in proportions|6.2|||||TWO_SIDED|95.0|1.8|13.0|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 23F||13.0|1.8|
70861308|NCT02718300|141209030|SUPERIORITY|||||||0.4046|||||||Van Elteren test|stratified by ECOG Performance Status at Screening (0 or 1 versus 2)||||||0.4046
70861309|NCT02718300|141209032|SUPERIORITY|||||||0.7802|||||||Van Elteren test|stratified by ECOG Performance Status at Screening (0 or 1 versus 2)||||||0.7802
70861310|NCT02718300|141209034|SUPERIORITY|||||||0.6856|||||||Van Elteren test|stratified by ECOG Performance Status at Screening (0 or 1 versus 2)||||||0.6856
70861311|NCT02718300|141209036|SUPERIORITY|||||||0.3385|||||||Van Elteren test|stratified by ECOG Performance Status at Screening (0 or 1 versus 2)||||||0.3385
70861312|NCT02718300|141209038|SUPERIORITY|||||||0.4005|||||||Van Elteren test|stratified by Easter Cooperative Oncology Group (ECOG) Performance Status at Screening (0 or 1 versus 2)||||||0.4005
70861313|NCT02718300|141209040|SUPERIORITY|||||||0.3138|||||||Van Elteren test|stratified by ECOG Performance Status at Screening (0 or 1 versus 2)||||||0.3138
70861314|NCT02718300|141209046|SUPERIORITY|||||||0.3577|||||||ANOVA|||Week 2||||0.3577
70861315|NCT02718300|141209046|SUPERIORITY||Geometric Mean Ratio (GMR)|1.048|||||TWO_SIDED|95.0|0.791|1.388|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 2||1.388|0.791|
70861316|NCT02718300|141209046|SUPERIORITY||GMR|1.159|||||TWO_SIDED|95.0|0.936|1.435|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 2||1.435|0.936|
70861317|NCT02718300|141209046|SUPERIORITY|||||||0.1709|||||||ANOVA|||Week 4||||0.1709
70947755|NCT01214421|141396381|SUPERIORITY||Ratio of geometric means (final values)|0.992||||0.108|TWO_SIDED|95.0|0.982|1.002|||Mixed Models Analysis||||Derived from linear mixed model with terms of participant, treatment, time, interaction of treatment and time, interaction of participant and time, and baseline for intra-participant comparison between 251 and 271. Time and intercept are treated as random effects.|1.002|0.982|0.1080
70947756|NCT01214421|141396382|SUPERIORITY||Ratio of geometric means (final values)|0.361||||0.2265|TWO_SIDED|95.0|-0.224|0.946|||Mixed Models Analysis||||Derived from linear mixed model with terms of participant, treatment, time, interaction of treatment and time, interaction of participant and time, and baseline for intra-participant comparison between 251 and 271. Time and intercept are treated as random effects.|0.946|-0.224|0.2265
70861318|NCT02718300|141209046|SUPERIORITY||GMR|1.0|||||TWO_SIDED|95.0|0.78|1.281|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.281|0.780|
70861319|NCT02718300|141209046|SUPERIORITY||GMR|1.176|||||TWO_SIDED|95.0|0.955|1.448|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.448|0.955|
70861320|NCT02718300|141209047|SUPERIORITY|||||||0.6693|||||||Kruskal-Wallis|||Week 2||||0.6693
70861321|NCT02718300|141209047|SUPERIORITY|||||||0.1521|||||||Kruskal-Wallis|||Week 4||||0.1521
70861322|NCT02718300|141209048|SUPERIORITY|||||||0.0809|||||||ANOVA|||Week 2||||0.0809
71133577|NCT03197376|141770087|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 1|3.47|||||TWO_SIDED|95.0|2.72|4.44||||||||4.44|2.72|
71133578|NCT03197376|141770087|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 5|2.54|||||TWO_SIDED|95.0|2.06|3.13||||||||3.13|2.06|
71133579|NCT03197376|141770087|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 6A|2.5|||||TWO_SIDED|95.0|1.83|3.42||||||||3.42|1.83|
71133580|NCT03197376|141770087|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 6B|3.76|||||TWO_SIDED|95.0|2.48|5.69||||||||5.69|2.48|
71133581|NCT03197376|141770087|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 7F|3.89|||||TWO_SIDED|95.0|2.92|5.18||||||||5.18|2.92|
71133582|NCT03197376|141770087|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 9V|6.85|||||TWO_SIDED|95.0|4.45|10.52||||||||10.52|4.45|
71133583|NCT03197376|141770087|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 14|2.45|||||TWO_SIDED|95.0|1.64|3.65||||||||3.65|1.64|
71133584|NCT03197376|141770087|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 19A|3.64|||||TWO_SIDED|95.0|2.47|5.36||||||||5.36|2.47|
71133585|NCT03197376|141770087|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 19F|2.38|||||TWO_SIDED|95.0|1.8|3.14||||||||3.14|1.80|
71133586|NCT03197376|141770087|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 23F|4.97|||||TWO_SIDED|95.0|3.49|7.06||||||||7.06|3.49|
71133587|NCT03197376|141770087|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 1|6.29|||||TWO_SIDED|95.0|4.97|7.96||||||||7.96|4.97|
71133588|NCT03197376|141770087|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 5|3.19|||||TWO_SIDED|95.0|2.56|3.98||||||||3.98|2.56|
71133589|NCT03197376|141770087|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 6A|6.21|||||TWO_SIDED|95.0|3.55|10.84||||||||10.84|3.55|
71133590|NCT03197376|141770087|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 6B|3.25|||||TWO_SIDED|95.0|2.25|4.7||||||||4.70|2.25|
70861323|NCT02718300|141209048|SUPERIORITY||GMR|0.583|||||TWO_SIDED|95.0|0.342|0.994|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 2||0.994|0.342|
71133591|NCT03197376|141770087|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 7F|2.81|||||TWO_SIDED|95.0|2.13|3.69||||||||3.69|2.13|
71133592|NCT03197376|141770087|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 9V|2.95|||||TWO_SIDED|95.0|2.15|4.04||||||||4.04|2.15|
71133593|NCT03197376|141770087|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 14|1.62|||||TWO_SIDED|95.0|1.06|2.46||||||||2.46|1.06|
70861324|NCT02718300|141209048|SUPERIORITY||GMR|0.986|||||TWO_SIDED|95.0|0.658|1.477|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 2||1.477|0.658|
70947757|NCT04887506|141396436|EQUIVALENCE|If the 90% confidence interval (CI) fell within the recommended 0.800-1.250 limits of equivalence when analyzed on a natural log scale, then treatments were therapeutically equivalent based on rounded-up average Days 9 and 10 testosterone levels.|Geometric mean ratio|1.0|||||TWO_SIDED|90.0|||||||The 90% CIs for the geometric mean ratio (GMR) were not evaluable.|Primary analysis of equivalence of TAVT 45 and R AA based on average serum testosterone (ng/dL) (rounded up values of Days 9 and 10).||||
70861325|NCT02718300|141209048|SUPERIORITY|||||||0.1525|||||||ANOVA|||Week 4||||0.1525
71133594|NCT03197376|141770087|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 19A|5.98|||||TWO_SIDED|95.0|3.88|9.21||||||||9.21|3.88|
71133595|NCT03197376|141770087|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 19F|1.97|||||TWO_SIDED|95.0|1.45|2.68||||||||2.68|1.45|
71133596|NCT03197376|141770087|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 23F|5.73|||||TWO_SIDED|95.0|3.8|8.63||||||||8.63|3.80|
71133597|NCT03197376|141770088|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 1|1.84|||||TWO_SIDED|95.0|1.25|2.72||||||||2.72|1.25|
70861326|NCT02718300|141209048|SUPERIORITY||GMR|1.062|||||TWO_SIDED|95.0|0.604|1.867|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.867|0.604|
70947758|NCT04887506|141396437|EQUIVALENCE|If the 90% CI fell within the recommended 0.800-1.250 limits of equivalence when analyzed on a natural log scale, then treatments were therapeutically equivalent based on rounded-up average Days 9 and 10 testosterone levels.|Geometric mean ratio|0.975|||||TWO_SIDED|90.0|0.944|1.007||||||Supplementary analysis of equivalence of TAVT-45 and R-AA based on average serum testosterone (ng/dL) (rounded up values of Days 9 and 10) in the CS-ITT population.||1.007|0.944|
70861327|NCT02718300|141209048|SUPERIORITY||GMR|1.504|||||TWO_SIDED|95.0|0.937|2.414|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||2.414|0.937|
70861328|NCT02718300|141209049|SUPERIORITY|||||||0.2873|||||||ANOVA|||Week 2||||0.2873
70861329|NCT02718300|141209049|SUPERIORITY||GMR|1.016|||||TWO_SIDED|95.0|0.773|1.336|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 2||1.336|0.773|
70861330|NCT02718300|141209049|SUPERIORITY||GMR|1.161|||||TWO_SIDED|95.0|0.943|1.429|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 2||1.429|0.943|
70861331|NCT02718300|141209049|SUPERIORITY|||||||0.1601|||||||ANOVA|||Week 4||||0.1601
70861332|NCT02718300|141209049|SUPERIORITY||GMR|0.992|||||TWO_SIDED|95.0|0.773|1.274|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.274|0.773|
71133598|NCT03197376|141770088|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 5|1.14|||||TWO_SIDED|95.0|0.79|1.64||||||||1.64|0.79|
71133599|NCT03197376|141770088|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 6A|68.1|||||TWO_SIDED|95.0|37.07|125.09||||||||125.09|37.07|
71133600|NCT03197376|141770088|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 6B|1.75|||||TWO_SIDED|95.0|1.25|2.46||||||||2.46|1.25|
71133601|NCT03197376|141770088|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 7F|1.73|||||TWO_SIDED|95.0|1.28|2.34||||||||2.34|1.28|
71133602|NCT03197376|141770088|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 9V|0.93|||||TWO_SIDED|95.0|0.65|1.32||||||||1.32|0.65|
71133603|NCT03197376|141770088|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 14|2.21|||||TWO_SIDED|95.0|1.38|3.51||||||||3.51|1.38|
71133604|NCT03197376|141770088|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 19A|12.54|||||TWO_SIDED|95.0|7.36|21.37||||||||21.37|7.36|
71133605|NCT03197376|141770088|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 19F|1.01|||||TWO_SIDED|95.0|0.7|1.46||||||||1.46|0.70|
71133606|NCT03197376|141770088|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 23F|3.14|||||TWO_SIDED|95.0|2.21|4.45||||||||4.45|2.21|
70861333|NCT02718300|141209049|SUPERIORITY||GMR|1.177|||||TWO_SIDED|95.0|0.955|1.452|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.452|0.955|
71133607|NCT03197376|141770089|NON_INFERIORITY|Non-inferiority will be shown if a two-sided 95% CI for the treatment-group difference in response proportions (proportion with Synflorix co-administration minus proportion with PNEUMOSIL co-administration) has an upper limit of \< 0.10.|Absolute difference for measles|1.7|||||TWO_SIDED|95.0|-3.3|7.4||||||||7.4|-3.3|
71133608|NCT03197376|141770089|NON_INFERIORITY|Non-inferiority will be shown if a two-sided 95% CI for the treatment-group difference in response proportions (proportion with Synflorix co-administration minus proportion with PNEUMOSIL co-administration) has an upper limit of \< 0.10.|Absolute difference for rubella|1.0|||||TWO_SIDED|95.0|-0.9|4.0||||||||4.0|-0.9|
71133609|NCT03197376|141770089|NON_INFERIORITY|Non-inferiority will be shown if a two-sided 95% CI for the treatment-group difference in response proportions (proportion with Synflorix co-administration minus proportion with PNEUMOSIL co-administration) has an upper limit of \< 0.10.|Absolute difference for yellow fever|2.4|||||TWO_SIDED|95.0|0.2|5.9||||||||5.9|0.2|
71133610|NCT03197376|141770090|OTHER|Treatment group difference in proportions|Absolute Difference for Type 1|16.2|||||TWO_SIDED|95.0|8.0|23.7||||||||23.7|8.0|
71133611|NCT03197376|141770090|OTHER|Treatment group difference in proportions|Absolute Difference for Type 5|7.2|||||TWO_SIDED|95.0|-1.4|15.8||||||||15.8|-1.4|
71133612|NCT03197376|141770090|OTHER|Treatment group difference in proportions|Absolute Difference for Type 6A|30.0|||||TWO_SIDED|95.0|21.8|38.1||||||||38.1|21.8|
71133613|NCT03197376|141770090|OTHER|Treatment group difference in proportions|Absolute Difference for Type 6B|16.5|||||TWO_SIDED|95.0|10.1|23.6||||||||23.6|10.1|
71133614|NCT03197376|141770090|OTHER|Treatment group difference in proportions|Absolute Difference for Type 7F|16.4|||||TWO_SIDED|95.0|8.4|24.5||||||||24.5|8.4|
71133615|NCT03197376|141770090|OTHER|Treatment group difference in proportions|Absolute Difference for Type 9V|-0.2|||||TWO_SIDED|95.0|-8.8|8.5||||||||8.5|-8.8|
71133616|NCT03197376|141770090|OTHER|Treatment group difference in proportions|Absolute Difference for Type 14|14.7|||||TWO_SIDED|95.0|7.5|22.3||||||||22.3|7.5|
71133617|NCT03197376|141770090|OTHER|Treatment group difference in proportions|Absolute Difference for Type 19A|14.7|||||TWO_SIDED|95.0|7.3|22.5||||||||22.5|7.3|
71133618|NCT03197376|141770090|OTHER|Treatment group difference in proportions|Absolute Difference for Type 19F|-13.7|||||TWO_SIDED|95.0|-19.0|-8.0||||||||-8.0|-19.0|
71133619|NCT03197376|141770090|OTHER|Treatment group difference in proportions|Absolute Difference for Type 23F|16.9|||||TWO_SIDED|95.0|8.2|25.4||||||||25.4|8.2|
71133620|NCT03197376|141770091|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 1 GMC Ratio|1.64|||||TWO_SIDED|95.0|1.42|1.89||||||||1.89|1.42|
70861334|NCT02718300|141209053|SUPERIORITY|||||||0.083|||||||ANOVA|||Day 1||||0.0830
70861335|NCT02718300|141209053|SUPERIORITY||GMR|1.218|||||TWO_SIDED|95.0|0.846|1.753|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.753|0.846|
70861336|NCT02718300|141209053|SUPERIORITY||GMR|0.957|||||TWO_SIDED|95.0|0.654|1.399|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.399|0.654|
70861337|NCT02718300|141209053|SUPERIORITY||GMR|0.943|||||TWO_SIDED|95.0|0.656|1.354|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.354|0.656|
70861338|NCT02718300|141209053|SUPERIORITY||GMR|0.867|||||TWO_SIDED|95.0|0.579|1.298|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.298|0.579|
70861339|NCT02718300|141209053|SUPERIORITY|||||||0.2402|||||||ANOVA|||Week 4||||0.2402
70861340|NCT02718300|141209053|SUPERIORITY||GMR|0.702|||||TWO_SIDED|95.0|0.461|1.069|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.069|0.461|
70861341|NCT02718300|141209053|SUPERIORITY||GMR|0.7|||||TWO_SIDED|95.0|0.456|1.073|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.073|0.456|
70861342|NCT02718300|141209053|SUPERIORITY||GMR|0.638|||||TWO_SIDED|95.0|0.428|0.951|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||0.951|0.428|
70861343|NCT02718300|141209053|SUPERIORITY||GMR|0.627|||||TWO_SIDED|95.0|0.397|0.99|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||0.990|0.397|
70861344|NCT02718300|141209054|SUPERIORITY|||||||0.0756|||||||Kruskal-Wallis|||Day 1||||0.0756
70861345|NCT02718300|141209054|SUPERIORITY|||||||0.0866|||||||Kruskal-Wallis|||Week 4||||0.0866
70861346|NCT02718300|141209055|SUPERIORITY|||||||0.4287|||||||ANOVA|||Day 1||||0.4287
71133621|NCT03197376|141770091|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 5 GMC Ratio|1.2|||||TWO_SIDED|95.0|1.03|1.4||||||||1.40|1.03|
70861347|NCT02718300|141209055|SUPERIORITY||GMR|1.272|||||TWO_SIDED|95.0|0.329|4.914|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||4.914|0.329|
70861348|NCT02718300|141209055|SUPERIORITY||GMR|1.036|||||TWO_SIDED|95.0|0.252|4.251|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||4.251|0.252|
70861349|NCT02718300|141209055|SUPERIORITY||GMR|0.702|||||TWO_SIDED|95.0|0.18|2.731|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||2.731|0.180|
70861350|NCT02718300|141209055|SUPERIORITY||GMR|0.525|||||TWO_SIDED|95.0|0.118|2.348|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||2.348|0.118|
70861351|NCT02718300|141209055|SUPERIORITY|||||||0.9788|||||||ANOVA|||Week 4||||0.9788
70861352|NCT02718300|141209055|SUPERIORITY||GMR|0.879|||||TWO_SIDED|95.0|0.198|3.896|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||3.896|0.198|
71133622|NCT03197376|141770091|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 6A GMC Ratio|2.36|||||TWO_SIDED|95.0|2.01|2.78||||||||2.78|2.01|
70861353|NCT02718300|141209055|SUPERIORITY||GMR|1.225|||||TWO_SIDED|95.0|0.27|5.56|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||5.560|0.270|
70861354|NCT02718300|141209055|SUPERIORITY||GMR|0.918|||||TWO_SIDED|95.0|0.221|3.821|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||3.821|0.221|
70861355|NCT02718300|141209055|SUPERIORITY||GMR|0.853|||||TWO_SIDED|95.0|0.169|4.299|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||4.299|0.169|
70861356|NCT02718300|141209056|SUPERIORITY|||||||0.1208|||||||ANOVA|||Day 1||||0.1208
70861357|NCT02718300|141209056|SUPERIORITY||GMR|1.251|||||TWO_SIDED|95.0|0.832|1.879|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.879|0.832|
70861358|NCT02718300|141209056|SUPERIORITY||GMR|0.992|||||TWO_SIDED|95.0|0.649|1.518|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.518|0.649|
70861359|NCT02718300|141209056|SUPERIORITY||GMR|0.967|||||TWO_SIDED|95.0|0.645|1.45|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.450|0.645|
70861360|NCT02718300|141209056|SUPERIORITY||GMR|0.86|||||TWO_SIDED|95.0|0.548|1.35|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.350|0.548|
70861361|NCT02718300|141209056|SUPERIORITY|||||||0.3218|||||||ANOVA|||Week 4||||0.3218
70861362|NCT02718300|141209056|SUPERIORITY||GMR|0.761|||||TWO_SIDED|95.0|0.482|1.2|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.200|0.482|
70861363|NCT02718300|141209056|SUPERIORITY||GMR|0.803|||||TWO_SIDED|95.0|0.506|1.277|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.277|0.506|
70861364|NCT02718300|141209056|SUPERIORITY||GMR|0.667|||||TWO_SIDED|95.0|0.432|1.028|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.028|0.432|
70861365|NCT02718300|141209056|SUPERIORITY||GMR|0.64|||||TWO_SIDED|95.0|0.39|1.051|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.051|0.390|
70861366|NCT05063318|141209067|SUPERIORITY||Least-squares geometric mean ratio|272.73|||||TWO_SIDED|90.0|213.22|348.86|||ANOVA|ANOVA mixed-effects model included treatment, period and sequence as fixed effects, and patient (sequence) as a random effect||||348.86|213.22|
70861367|NCT05063318|141209068|SUPERIORITY||Least-squares geometric mean ratio|236.73|||||TWO_SIDED|90.0|177.35|316.0|||ANOVA|ANOVA mixed-effects model included treatment, period and sequence as fixed effects, and patient (sequence) as a random effect||||316.00|177.35|
70861368|NCT05063318|141209069|SUPERIORITY||least-squares geometric mean ratio.|115.51|||||TWO_SIDED|90.0|100.07|133.33|||ANOVA|ANOVA mixed-effects model included treatment, period and sequence as fixed effects, and patient (sequence) as a random effect||||133.33|100.07|
70861369|NCT05063318|141209070|SUPERIORITY||Least-squares geometric mean ratio.|217.57|||||TWO_SIDED|90.0|151.81|311.82|||ANOVA|ANOVA mixed-effects model included treatment, period and sequence (TR or RT) as fixed effects, and patient (sequence) as a random effect.||||311.82|151.81|
70861370|NCT05063318|141209071|SUPERIORITY||Least-squares geometric mean ratio|36.67|||||TWO_SIDED|90.0|28.66|46.9|||ANOVA|ANOVA mixed-effects model included treatment, period and sequence as fixed effects, and patient (sequence) as a random effect||||46.9|28.66|
70861371|NCT05063318|141209072|SUPERIORITY||Least-squares geometric mean ratio|99.89|||||TWO_SIDED|90.0|65.76|151.74|||ANOVA|ANOVA mixed-effects model included treatment, period and sequence as fixed effects, and patient (sequence) as a random effect||||151.74|65.76|
70861372|NCT00729924|141209073|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||The p-value is not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The hypothesis was that the ratio of the 4-hour CSF concentration value to the partial plasma area-under-the-curve 0-4h value would differ between participants with ABCB1 C/C and T/T genotypes.||||0.43
70861373|NCT00729924|141209074|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||The p-value is not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||We explored post-hoc whether the ratio of the 4-hour CSF concentration value to the 2-hour plasma concentration differs between participants with ABCB1 C/C and T/T genotypes.||||0.43
70861374|NCT04233034|141209098|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.89|TWO_SIDED|95.0|-0.11|0.1|||Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and drug group as fixed effects and clinical site as a random effect.|Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.10|-0.11|0.89
70861375|NCT04233034|141209098|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.04|TWO_SIDED|95.0|0.01|0.27|||Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and Intensive group as fixed effects and clinical site as a random effect.|Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.27|0.01|0.04
70861376|NCT04233034|141209099|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.8|TWO_SIDED|95.0|-0.1|0.08||P-value adjusted for multiplicity using the Benjamini-Hochberg procedure.|Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and drug group as fixed effects and clinical site as a random effect.|Mean difference (HCL - Non-HCL) at 13 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.08|-0.10|0.80
70861377|NCT04233034|141209099|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.8|TWO_SIDED|95.0|-0.08|0.13||P-value adjusted for multiplicity using the Benjamini-Hochberg procedure.|Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and drug group as fixed effects and clinical site as a random effect.|Mean difference (HCL - Non-HCL) at 26 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.13|-0.08|0.80
70947759|NCT04887506|141396438|EQUIVALENCE|If the 90% CI fell within the recommended 0.800-1.250 limits of equivalence when analyzed on a natural log scale, then treatments were therapeutically equivalent based on rounded-up average Days 9 and 10 testosterone levels.|Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.978|1.002||||||Supplementary analysis of equivalence of TAVT-45 and R-AA based on average serum testosterone (ng/dL) (rounded up values of Days 9 and 10) in the mITT population.||1.002|0.978|
70861378|NCT04233034|141209099|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.8|TWO_SIDED|95.0|-0.13|0.09||P-value was adjusted for multiplicity using the Benjamini-Hochberg procedure.|Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and drug group as fixed effects and clinical site as a random effect.|Mean difference (HCL - Non-HCL) at 39 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.09|-0.13|0.80
70861379|NCT04233034|141209099|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.69|TWO_SIDED|95.0|-0.09|0.13||P-value adjusted for multiplicity using the Benjamini-Hochberg procedure.|Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and Intensive group as fixed effects and clinical site as a random effect.|Mean difference (Verapamil - Placebo) at 13 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.13|-0.09|0.69
70861380|NCT04233034|141209099|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.08|TWO_SIDED|95.0|-0.02|0.25||P-value was adjusted for multiplicity using the Benjamini-Hochberg procedure.|Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and Intensive group as fixed effects and clinical site as a random effect.|Mean difference (Verapamil - Placebo) at 26 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.25|-0.02|0.08
70861381|NCT04233034|141209099|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.08|TWO_SIDED|95.0|-0.01|0.28||P-value adjusted for multiplicity using the Benjamini-Hochberg procedure.|Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and Intensive group as fixed effects and clinical site as a random effect.|Mean difference (Verapamil - Placebo) at 39 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.28|-0.01|0.08
70861382|NCT04233034|141209102|SUPERIORITY||Mean Difference (Final Values)|-25.0|||<|0.001|TWO_SIDED|95.0|-37.0|-14.0|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||-14|-37|<0.001
70861383|NCT04233034|141209102|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.74|TWO_SIDED|95.0|-25.0|16.0|||Mixed Models Analysis||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||16|-25|0.74
70861384|NCT04233034|141209103|SUPERIORITY||Mean Difference (Final Values)|16.0|||<|0.001|TWO_SIDED|95.0|10.0|22.0|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||22|10|<0.001
70861385|NCT04233034|141209103|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.74|TWO_SIDED|95.0|-9.0|13.0|||Mixed Models Analysis||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||13|-9|0.74
70947760|NCT04887506|141396439|EQUIVALENCE|Odds ratio generated using the Wald method.|Odds Ratio (OR)|1.69||||0.3408|TWO_SIDED|95.0|0.574|4.979|||Regression, Logistic|||||4.979|0.574|0.3408
70947761|NCT01999777|141396440|SUPERIORITY|||||||0.1972|||||||Wald asymptotic|P-value based on a standard Wald asymptotic test for equality without a continuity correction.||Assumptions included that the proportion of seizures occurring within 6 hours after placebo administration was \~65% and a relative reduction of 50% would result in a reduction of ≥ 32.5 percentage points. Based on a 2-sided 95% confidence interval (CI) for the differences in proportions, a sample size of 62 analyzable subjects was chosen to detect a 0.35 difference between group. Sample size estimations were based on nQuery Version 7.0 using the table for CIs for differences in 2 proportions.||||0.1972
71133623|NCT03197376|141770091|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 6B GMC Ratio|1.45|||||TWO_SIDED|95.0|1.27|1.66||||||||1.66|1.27|
70861386|NCT04233034|141209104|SUPERIORITY||Mean Difference (Final Values)|16.0|||<|0.001|TWO_SIDED|95.0|10.0|22.0|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||22|10|<0.001
71133624|NCT03197376|141770091|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 7F GMC Ratio|1.29|||||TWO_SIDED|95.0|1.12|1.49||||||||1.49|1.12|
71133625|NCT03197376|141770091|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 9V GMC Ratio|0.94|||||TWO_SIDED|95.0|0.81|1.09||||||||1.09|0.81|
71133626|NCT03197376|141770091|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 14 GMC Ratio|1.41|||||TWO_SIDED|95.0|1.15|1.72||||||||1.72|1.15|
71133627|NCT03197376|141770091|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 19A GMC Ratio|1.38|||||TWO_SIDED|95.0|1.14|1.68||||||||1.68|1.14|
71133628|NCT03197376|141770091|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 19F GMC Ratio|0.61|||||TWO_SIDED|95.0|0.5|0.74||||||||0.74|0.50|
71133629|NCT03197376|141770091|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 23F GMC Ratio|1.5|||||TWO_SIDED|95.0|1.24|1.81||||||||1.81|1.24|
71133630|NCT03197376|141770092|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 1 GMC Ratio|0.05|||||TWO_SIDED|95.0|0.05|0.06||||||||0.06|0.05|
71133631|NCT03197376|141770092|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 5 GMC Ratio|0.3|||||TWO_SIDED|95.0|0.27|0.33||||||||0.33|0.27|
71133632|NCT03197376|141770092|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 6A GMC Ratio|0.15|||||TWO_SIDED|95.0|0.13|0.16||||||||0.16|0.13|
71133633|NCT03197376|141770092|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 6B GMC Ratio|0.11|||||TWO_SIDED|95.0|0.1|0.11||||||||0.11|0.10|
71133634|NCT03197376|141770092|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 7F GMC Ratio|0.1|||||TWO_SIDED|95.0|0.09|0.11||||||||0.11|0.09|
71133635|NCT03197376|141770092|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 9V GMC Ratio|0.21|||||TWO_SIDED|95.0|0.19|0.23||||||||0.23|0.19|
71133636|NCT03197376|141770092|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 14 GMC Ratio|0.15|||||TWO_SIDED|95.0|0.13|0.17||||||||0.17|0.13|
71133637|NCT03197376|141770092|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 19A GMC Ratio|0.23|||||TWO_SIDED|95.0|0.2|0.26||||||||0.26|0.20|
71133638|NCT03197376|141770092|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 19F GMC Ratio|0.14|||||TWO_SIDED|95.0|0.12|0.15||||||||0.15|0.12|
71133639|NCT03197376|141770092|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 23F GMC Ratio|0.11|||||TWO_SIDED|95.0|0.1|0.12||||||||0.12|0.10|
71133640|NCT03197376|141770092|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 1 GMC Ratio|0.07|||||TWO_SIDED|95.0|0.06|0.08||||||||0.08|0.06|
71133641|NCT03197376|141770092|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 5 GMC Ratio|0.4|||||TWO_SIDED|95.0|0.35|0.45||||||||0.45|0.35|
71133642|NCT03197376|141770092|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 6A GMC Ratio|0.73|||||TWO_SIDED|95.0|0.62|0.86||||||||0.86|0.62|
71133643|NCT03197376|141770092|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 6B GMC Ratio|0.14|||||TWO_SIDED|95.0|0.12|0.16||||||||0.16|0.12|
71133644|NCT03197376|141770092|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 7F GMC Ratio|0.12|||||TWO_SIDED|95.0|0.11|0.13||||||||0.13|0.11|
71133645|NCT03197376|141770092|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 9V GMC Ratio|0.2|||||TWO_SIDED|95.0|0.18|0.22||||||||0.22|0.18|
70861387|NCT04233034|141209104|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.95|TWO_SIDED|95.0|-8.0|14.0|||Mixed Models Analysis||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||14|-8|0.95
70861388|NCT04233034|141209105|SUPERIORITY||Risk Difference (RD)|0.38|||<|0.001|TWO_SIDED|95.0|0.21|0.53|||Regression, Logistic|||||0.53|0.21|<0.001
70861389|NCT04233034|141209105|SUPERIORITY||Risk Difference (RD)|0.03||||0.79|TWO_SIDED|95.0|-0.26|0.32|||Regression, Logistic|||||0.32|-0.26|0.79
70947762|NCT01999777|141396441|SUPERIORITY|||||||0.1388|||||||Log Rank|||||||0.1388
70861390|NCT04233034|141209107|SUPERIORITY||Mean Difference (Final Values)|-16.0|||<|0.001|TWO_SIDED|95.0|-22.0|-9.0|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||-9|-22|<0.001
70947763|NCT03506347|141396468|SUPERIORITY|||||||0.001|||||||ANOVA|||||||0.001
70947764|NCT03506347|141396469|SUPERIORITY|||||||0.009|||||||ANOVA|||||||0.009
70947765|NCT05613088|141396482|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.4063|TWO_SIDED|95.0|0.76|2.0|||Log Rank|||||2.00|0.76|0.4063
70947766|NCT03912532|141396483|OTHER|The Multiple Comparison Procedure-Modelling (MCP-Mod) is a 2-stage procedure in which dose-response models are selected at the design stage. These candidate models are used for both dose-response testing (MCP step) and estimation (Mod step). The dose-response testing is performed using a multiple comparison method to account for the multiplicity issue associated with the multiple candidate models. Missing responses were imputed using multiple imputation under the assumption of missing at random.||||||0.5534|||||||Multiple comparison procedure step|||||||0.5534
70947767|NCT01641653|141396534|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This is a pilot study no power calculation was performed. The Wilcoxon rank-sum test was used to assess differences in max intraop glucose between placebo and midazolam groups.||||0.87
70947768|NCT01641653|141396535|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|10.0||||0.56|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||percent change in glucose levels from preoperative level to maximum perioperative measurement level||||0.56
70947769|NCT01641653|141396536|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED|||||Chi-square with continuity correction|Chi-squared, Corrected|||||||0.12
70947770|NCT02825251|141396537|NON_INFERIORITY|Non-inferiority of faster aspart was considered confirmed if the upper limit of the two-sided 95 % CI for the true treatment-difference D (faster aspart minus NovoRapid®) was below 0.4 %.|Treatment difference|0.09|||||TWO_SIDED|95.0|0.01|0.17|||ANOVA|||Change from baseline in HbA1c was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model included treatment, strata (use of own continuous glucose monitoring), previous insulin use, and region as factors, and baseline HbA1c as a covariate.||0.17|0.01|
70947771|NCT01473745|141396632|SUPERIORITY_OR_OTHER|||||||0.098|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||ANS X axis||||0.098
71133646|NCT03197376|141770092|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 14 GMC Ratio|0.15|||||TWO_SIDED|95.0|0.13|0.19||||||||0.19|0.13|
71133647|NCT03197376|141770092|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 19A GMC Ratio|0.64|||||TWO_SIDED|95.0|0.52|0.78||||||||0.78|0.52|
70947772|NCT01473745|141396632|SUPERIORITY_OR_OTHER|||||||0.389|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||ANS Y axis||||0.389
71133648|NCT03197376|141770092|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 19F GMC Ratio|0.14|||||TWO_SIDED|95.0|0.12|0.16||||||||0.16|0.12|
71133649|NCT03197376|141770092|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 23F GMC Ratio|0.14|||||TWO_SIDED|95.0|0.12|0.16||||||||0.16|0.12|
71133650|NCT03197376|141770093|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 1|24.2|||||TWO_SIDED|95.0|4.5|42.1||||||||42.1|4.5|
71133651|NCT03197376|141770093|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 5|9.9|||||TWO_SIDED|95.0|-5.8|25.5||||||||25.5|-5.8|
70947773|NCT01473745|141396632|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||ANS Z axis||||0.780
70947774|NCT01473745|141396632|SUPERIORITY_OR_OTHER|||||||0.054|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||A point X axis||||0.054
70947775|NCT01473745|141396632|SUPERIORITY_OR_OTHER|||||||0.323|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||A point Y axis||||0.323
70947776|NCT01473745|141396632|SUPERIORITY_OR_OTHER|||||||0.371|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||A point X axis||||0.371
70947777|NCT01473745|141396632|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||UI level X axis||||0.011
70947778|NCT01473745|141396632|SUPERIORITY_OR_OTHER|||||||0.426|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||UI level Y axis||||0.426
70947779|NCT01473745|141396632|SUPERIORITY_OR_OTHER|||||||0.621|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||UI level Z axis||||0.621
70947780|NCT01473745|141396632|SUPERIORITY_OR_OTHER|||||||0.275|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||pronasale X axis||||0.275
70947781|NCT01473745|141396632|SUPERIORITY_OR_OTHER|||||||0.361|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||pronasale Y axis||||0.361
70947782|NCT01473745|141396632|SUPERIORITY_OR_OTHER|||||||0.284|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||pronasale Z axis||||0.284
70947783|NCT01473745|141396632|SUPERIORITY_OR_OTHER|||||||0.119|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||subnasale X axis||||0.119
70947784|NCT01473745|141396632|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||subnasale Y axis||||0.019
71133652|NCT03197376|141770093|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 6A|65.6|||||TWO_SIDED|95.0|48.3|78.0||||||||78.0|48.3|
70861391|NCT04233034|141209107|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.74|TWO_SIDED|95.0|-13.0|9.0|||Mixed Models Analysis||Mean difference at 52 weeks (verapamil - placebo) adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||9|-13|0.74
70861392|NCT04233034|141209108|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.003|TWO_SIDED|95.0|-7.0|-1.0|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||-1|-7|0.003
70861393|NCT04233034|141209108|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.74|TWO_SIDED|95.0|-6.0|4.0|||Mixed Models Analysis||Mean difference (verapamil - placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||4|-6|0.74
70861394|NCT04233034|141209109|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.23|TWO_SIDED|95.0|-0.04|0.17|||Regression, Linear||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.17|-0.04|0.23
70861395|NCT04233034|141209109|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.79|TWO_SIDED|95.0|-1.0|0.6|||Regression, Linear||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.6|-1.0|0.79
70861396|NCT04233034|141209110|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.39|TWO_SIDED|95.0|-0.3|0.7|||Regression, Linear||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.7|-0.3|0.39
70861397|NCT04233034|141209110|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.74|TWO_SIDED|95.0|-1.0|0.6|||Regression, Linear||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.6|-1.0|0.74
70861398|NCT04233034|141209112|SUPERIORITY||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.1|-0.3|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||-0.3|-1.1|<0.001
70861399|NCT04233034|141209112|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.65|TWO_SIDED|95.0|-1.0|0.4|||Mixed Models Analysis||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.4|-1.0|0.65
70861400|NCT04233034|141209115|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.07|TWO_SIDED|95.0|-0.01|0.2|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.20|-0.01|0.07
70861401|NCT04233034|141209115|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.52|TWO_SIDED|95.0|-0.3|0.05|||Mixed Models Analysis||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.05|-0.30|0.52
70861402|NCT02791399|141209119|EQUIVALENCE|Our analysis examined the estimated averages for each group at each time point after accounting for covariates.|Mean Difference (Final Values)|-1.12|||<|0.05|TWO_SIDED|95.0|-2.45|0.2|||Mixed Models Analysis|Models controlled for age, gender, depression severity, pain intensity, clinician type, and proportion of clinician panel prescribed opioids.||||0.20|-2.45|<0.05
70861403|NCT02791399|141209120|EQUIVALENCE|Our analysis examined the estimated probabilities for each group at each time point after accounting for covariates.|Mean Difference (Final Values)|-0.04|||<|0.05|TWO_SIDED|95.0|-0.15|0.06|||Mixed Models Analysis|Models controlled for age, gender, depression severity, pain intensity, clinician type, and proportion of clinician panel prescribed opioids.||||0.06|-0.15|<0.05
70861404|NCT02791399|141209121|NON_INFERIORITY|Pain intensity and pain-related function were tested in non-inferiority analyses, as we hypothesized that the ISOT intervention would not negatively impact pain or function. One-half SD difference in change was considered the appropriate non-inferiority limit.|Non-inferiority analysis|1.6|||||TWO_SIDED|||||||||||||
70861405|NCT02791399|141209122|EQUIVALENCE|This analysis is comparing estimated averages and probabilities for each group at each time point after accounting for covariates.|Mean Difference (Final Values)|-1.99|||<|0.05|TWO_SIDED|95.0|-5.83|1.85|||Mixed Models Analysis|Models controlled for age, gender, depression severity, pain intensity, clinician type, and proportion of clinician panel prescribed opioids.||||1.85|-5.83|<0.05
70861406|NCT02791399|141209123|EQUIVALENCE|Our analysis examined the estimated averages for each group at each time point after accounting for covariates.|Mean Difference (Final Values)|1.03|||<|0.05|TWO_SIDED|95.0|-6.73|8.8|||Mixed Models Analysis|Models controlled for age, gender, depression severity, pain intensity, clinician type, and proportion of clinician panel prescribed opioids.||||8.80|-6.73|<0.05
70861407|NCT01865084|141209150|SUPERIORITY_OR_OTHER_LEGACY|||||||0.307||||||The p-value is based on the treatment difference LS Mean changes from baseline between tadalafil and placebo.|Mixed Models Analysis|||||||0.307
70861408|NCT01865084|141209150|SUPERIORITY_OR_OTHER_LEGACY|||||||0.538||||||The p-value is based on the treatment difference LS Mean changes from baseline between tadalafil and placebo.|Mixed Models Analysis|||||||0.538
70861409|NCT03607422|141209158|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|59.6|||<|0.001|TWO_SIDED|95.0|53.1|66.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||66.2|53.1|<0.001
70861410|NCT03607422|141209158|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|46.9|||<|0.001|TWO_SIDED|95.0|39.9|53.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||53.9|39.9|<0.001
71133653|NCT03197376|141770093|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 6B|23.2|||||TWO_SIDED|95.0|6.4|39.4||||||||39.4|6.4|
70947785|NCT01473745|141396632|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||subnasale Z axis||||0.034
71133654|NCT03197376|141770093|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 7F|2.0|||||TWO_SIDED|95.0|-5.2|10.8||||||||10.8|-5.2|
71133655|NCT03197376|141770093|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 9V|0.0|||||TWO_SIDED||||||||CI could not be computed due to 100% response rate|||||
70947786|NCT01473745|141396632|SUPERIORITY_OR_OTHER|||||||0.422|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||labiale superious X axis||||0.422
70947787|NCT01473745|141396632|SUPERIORITY_OR_OTHER|||||||0.177|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||labiale superious Y axis||||0.177
71133656|NCT03197376|141770093|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type14|4.6|||||TWO_SIDED|95.0|-8.5|18.3||||||||18.3|-8.5|
71133657|NCT03197376|141770093|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 19A|34.4|||||TWO_SIDED|95.0|16.5|50.8||||||||50.8|16.5|
71133658|NCT03197376|141770093|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 19F|5.0|||||TWO_SIDED|95.0|-8.4|19.2||||||||19.2|-8.4|
71133659|NCT03197376|141770093|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 23F|0.0|||||TWO_SIDED||||||||CI could not be computed due to 100% response rate|||||
71133660|NCT03197376|141770094|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 1|1.3|||||TWO_SIDED|95.0|0.8|2.1||||||||2.1|0.8|
71133661|NCT03197376|141770094|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 5|1.3|||||TWO_SIDED|95.0|0.7|2.4||||||||2.4|0.7|
71133662|NCT03197376|141770094|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 6A|14.3|||||TWO_SIDED|95.0|6.3|32.1||||||||32.1|6.3|
71133663|NCT03197376|141770094|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 6B|3.7|||||TWO_SIDED|95.0|2.1|6.8||||||||6.8|2.1|
71133664|NCT03197376|141770094|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 7F|1.0|||||TWO_SIDED|95.0|0.6|1.6||||||||1.6|0.6|
71133665|NCT03197376|141770094|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 9V|0.7|||||TWO_SIDED|95.0|0.3|1.7||||||||1.7|0.3|
71133666|NCT03197376|141770094|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 14|1.1|||||TWO_SIDED|95.0|0.5|2.4||||||||2.4|0.5|
71133667|NCT03197376|141770094|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 19A|5.1|||||TWO_SIDED|95.0|2.4|10.8||||||||10.8|2.4|
71133668|NCT03197376|141770094|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 19F|1.0|||||TWO_SIDED|95.0|0.4|2.3||||||||2.3|0.4|
71133669|NCT03197376|141770094|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 23F|4.3|||||TWO_SIDED|95.0|2.0|9.4||||||||9.4|2.0|
71133670|NCT03197376|141770095|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 1|0.04|||||TWO_SIDED|95.0|0.03|0.06||||||||0.06|0.03|
71133671|NCT03197376|141770095|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 5|0.11|||||TWO_SIDED|95.0|0.09|0.14||||||||0.14|0.09|
71133672|NCT03197376|141770095|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 6A|0.05|||||TWO_SIDED|95.0|0.03|0.08||||||||0.08|0.03|
71133673|NCT03197376|141770095|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 6B|0.05|||||TWO_SIDED|95.0|0.03|0.07||||||||0.07|0.03|
71133674|NCT03197376|141770095|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 7F|0.26|||||TWO_SIDED|95.0|0.18|0.38||||||||0.38|0.18|
71133675|NCT03197376|141770095|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 9V|0.12|||||TWO_SIDED|95.0|0.06|0.23||||||||0.23|0.06|
71133676|NCT03197376|141770095|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 14|0.07|||||TWO_SIDED|95.0|0.05|0.11||||||||0.11|0.05|
71133677|NCT03197376|141770095|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 19A|0.16|||||TWO_SIDED|95.0|0.09|0.3||||||||0.30|0.09|
71133678|NCT03197376|141770095|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 19F|0.09|||||TWO_SIDED|95.0|0.05|0.18||||||||0.18|0.05|
70861411|NCT03607422|141209159|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|47.4|||<|0.001|TWO_SIDED|95.0|41.0|53.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||53.7|41.0|<0.001
70861412|NCT03607422|141209159|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|34.0|||<|0.001|TWO_SIDED|95.0|27.8|40.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||40.2|27.8|<0.001
70861413|NCT03607422|141209160|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|50.4|||<|0.001|TWO_SIDED|95.0|43.8|57.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||57.1|43.8|<0.001
70861414|NCT03607422|141209160|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|32.6|||<|0.001|TWO_SIDED|95.0|25.8|39.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||39.4|25.8|<0.001
70861415|NCT03607422|141209161|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|53.1|||<|0.001|TWO_SIDED|95.0|46.7|59.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||59.4|46.7|<0.001
70861416|NCT03607422|141209161|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|36.9|||<|0.001|TWO_SIDED|95.0|30.6|43.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||43.3|30.6|<0.001
70861417|NCT03607422|141209162|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|57.0|||<|0.001|TWO_SIDED|95.0|50.9|63.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||63.0|50.9|<0.001
70861418|NCT03607422|141209162|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|45.2|||<|0.001|TWO_SIDED|95.0|38.9|51.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||51.4|38.9|<0.001
70861419|NCT03607422|141209163|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|40.4|||<|0.001|TWO_SIDED|95.0|34.2|46.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||46.5|34.2|<0.001
70947788|NCT01473745|141396632|SUPERIORITY_OR_OTHER|||||||0.133|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||labiale superious Z axis||||0.133
70872127|NCT02155608|141229496|SUPERIORITY|||||||0.39|||||||Mixed Models Analysis|Time: F = .74, df = 1/58.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parametrized in the model as a standard linear viable, time (ranging from baseline to 4 weeks) and a second variable, time2. defined as 0 at baseline and time past week 1 for subsequent weeks. The time 2 coefficient represents the change in slope after the initial week.||||.39
70947789|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.218|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||Intercanthal distance||||0.218
70947790|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.336|TWO_SIDED||||||t-test, 2 sided|P- value \< 0.05 was set as statistical significance.||nasal height||||0.336
70947791|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.192|TWO_SIDED||||||t-test, 2 sided|P- value \< 0.05 was set as statistical significance||||||0.192
71133679|NCT03197376|141770095|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 23F|0.12|||||TWO_SIDED|95.0|0.08|0.18||||||||0.18|0.08|
70861420|NCT03607422|141209163|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|29.4|||<|0.001|TWO_SIDED|95.0|23.5|35.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||35.3|23.5|<0.001
70861421|NCT03607422|141209164|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|14.9|||<|0.001|TWO_SIDED|95.0|10.6|19.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||19.3|10.6|<0.001
70861422|NCT03607422|141209164|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|6.7|||<|0.001|TWO_SIDED|95.0|3.4|10.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||10.0|3.4|<0.001
70861423|NCT03607422|141209165|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|7.2|||<|0.001|TWO_SIDED|95.0|3.8|10.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||10.5|3.8|<0.001
70861424|NCT03607422|141209166|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|8.6|||<|0.001|TWO_SIDED|95.0|4.3|12.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||12.9|4.3|<0.001
70861425|NCT03607422|141209167|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|-23.1|||<|0.001|TWO_SIDED|95.0|-28.4|-17.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||-17.8|-28.4|<0.001
70861426|NCT03607422|141209167|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|-22.4|||<|0.001|TWO_SIDED|95.0|-27.8|-16.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||-16.9|-27.8|<0.001
70861427|NCT03607422|141209168|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|49.8|||<|0.001|TWO_SIDED|95.0|42.2|57.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||57.3|42.2|<0.001
70861428|NCT03607422|141209168|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|37.9|||<|0.001|TWO_SIDED|95.0|30.1|45.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||45.8|30.1|<0.001
70861429|NCT03607422|141209169|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|51.8|||<|0.001|TWO_SIDED|95.0|44.4|59.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||59.1|44.4|<0.001
70861430|NCT03607422|141209169|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|35.9|||<|0.001|TWO_SIDED|95.0|28.2|43.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||43.5|28.2|<0.001
70947792|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.135|TWO_SIDED||||||t-test, 2 sided|P value \< 0.05 was set as statistical significance.||nasal tip protrusion||||0.135
70947793|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.277|TWO_SIDED||||||t-test, 2 sided|P value \< 0.05 was set as statistical significance.||nasal width||||0.277
70947794|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.505|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||alar base width||||0.505
71133680|NCT03197376|141770095|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 1|0.04|||||TWO_SIDED|95.0|0.03|0.06||||||||0.06|0.03|
71133681|NCT03197376|141770095|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 5|0.07|||||TWO_SIDED|95.0|0.05|0.1||||||||0.10|0.05|
71133682|NCT03197376|141770095|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 6A|0.21|||||TWO_SIDED|95.0|0.09|0.48||||||||0.48|0.09|
71133683|NCT03197376|141770095|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 6B|0.02|||||TWO_SIDED|95.0|0.01|0.03||||||||0.03|0.01|
71133684|NCT03197376|141770095|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 7F|0.44|||||TWO_SIDED|95.0|0.3|0.65||||||||0.65|0.30|
71133685|NCT03197376|141770095|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 9V|0.11|||||TWO_SIDED|95.0|0.06|0.2||||||||0.20|0.06|
71133686|NCT03197376|141770095|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 14|0.11|||||TWO_SIDED|95.0|0.06|0.22||||||||0.22|0.06|
70861431|NCT03607422|141209170|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|53.3|||<|0.001|TWO_SIDED|95.0|46.0|60.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||60.6|46.0|<0.001
70861432|NCT03607422|141209170|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|40.3|||<|0.001|TWO_SIDED|95.0|32.7|48.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||48.0|32.7|<0.001
70947795|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.299|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||R nostril show vertical dimension||||0.299
70947796|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.738|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||L nostril show vertical dimension||||0.738
71133687|NCT03197376|141770095|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 19A|0.26|||||TWO_SIDED|95.0|0.14|0.49||||||||0.49|0.14|
71133688|NCT03197376|141770095|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 19F|0.09|||||TWO_SIDED|95.0|0.06|0.14||||||||0.14|0.06|
70947797|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||columellar length||||0.008
71133689|NCT03197376|141770095|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 23F|0.07|||||TWO_SIDED|95.0|0.05|0.12||||||||0.12|0.05|
71133690|NCT01223183|141770101|EQUIVALENCE|alpha=0.05|||||<|0.001|||||||t-test, 2 sided|||Comparing DTPA absorption after hypertonic saline inhalation to DTPA absorption after isotonic saline inhalation||||<0.001
71133691|NCT01223183|141770103|EQUIVALENCE|alpha=0.05||||||0.003|||||||t-test, 2 sided|||Comparing mucociliary clearance after isotonic saline inhalation to mucociliary clearance after hypertonic saline inhalation||||0.003
71133692|NCT02309944|141770104|SUPERIORITY|||||||0.27|TWO_SIDED|95.0|||||Chi-squared|||Negative Pressure Wound Therapy vs. Standard Wound Closure||||0.27
71133693|NCT02309944|141770104|SUPERIORITY|||||||0.24|||||||Regression, Logistic|Multivariate Model (adjusted for ascites and previous laparotomy)||Negative Pressure Wound Therapy vs. Standard Wound Closure||||0.24
70947798|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.116|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||cutaneious height of upper lip||||0.116
70947799|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.528|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||overall upper lip height||||0.528
70947800|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.123|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||vermillion height of upper lip||||0.123
70947801|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||lower prolabial width||||0.250
71133694|NCT03777059|141770120|SUPERIORITY||Least Squares Mean Difference|-1.21|STANDARD_ERROR_OF_MEAN|0.291|<|0.0001|TWO_SIDED|95.0|-1.78|-0.64||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.64|-1.78|<.0001
71133695|NCT03777059|141770120|SUPERIORITY||Least Squares Mean Difference|-1.38|STANDARD_ERROR_OF_MEAN|0.287|<|0.0001|TWO_SIDED|95.0|-1.94|-0.82||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.82|-1.94|<.0001
71133696|NCT03777059|141770120|SUPERIORITY||Least Squares Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|0.288|<|0.0001|TWO_SIDED|95.0|-2.28|-1.15||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-1.15|-2.28|<.0001
71133697|NCT03777059|141770121|SUPERIORITY||Least Squares Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|0.311|<|0.0001|TWO_SIDED|95.0|-2.03|-0.81||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.81|-2.03|<.0001
71133698|NCT03777059|141770121|SUPERIORITY||Least Squares Mean Difference|-1.53|STANDARD_ERROR_OF_MEAN|0.307|<|0.0001|TWO_SIDED|95.0|-2.13|-0.92||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.92|-2.13|<.0001
71133699|NCT03777059|141770121|SUPERIORITY||Least Squares Mean Difference|-1.71|STANDARD_ERROR_OF_MEAN|0.309|<|0.0001|TWO_SIDED|95.0|-2.32|-1.1||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-1.10|-2.32|<.0001
71133700|NCT03777059|141770122|SUPERIORITY||Least Squares Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.254|<|0.0001|TWO_SIDED|95.0|-1.81|-0.82||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.82|-1.81|<.0001
70947802|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.706|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||upper lip protrusion||||0.706
70947803|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.804|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||intercanthal distance||||0.804
70947804|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.114|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||nasal height||||0.114
70861433|NCT03607422|141209171|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|54.8|||<|0.001|TWO_SIDED|95.0|47.2|62.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||62.3|47.2|<0.001
70861434|NCT03607422|141209171|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|40.3|||<|0.001|TWO_SIDED|95.0|32.3|48.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||48.3|32.3|<0.001
70861435|NCT03607422|141209172|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|50.6|||<|0.001|TWO_SIDED|95.0|42.8|58.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||58.5|42.8|<0.001
70861436|NCT03607422|141209172|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|37.9|||<|0.001|TWO_SIDED|95.0|29.5|46.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||46.3|29.5|<0.001
70861437|NCT03607422|141209173|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|18.1|||<|0.0001|TWO_SIDED|95.0|13.5|22.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||22.7|13.5|<0.0001
70861438|NCT03607422|141209173|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|13.4|||<|0.001|TWO_SIDED|95.0|9.2|17.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||17.6|9.2|<0.001
70872128|NCT02155608|141229496|SUPERIORITY|||||||0.18|||||||Mixed Models Analysis|Time2: F = 1.88, df = 1/58.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parametrized in the model as a standard linear viable, time (ranging from baseline to 4 weeks) and a second variable, time2. defined as 0 at baseline and time past week 1 for subsequent weeks. The time 2 coefficient represents the change in slope after the initial week.||||.18
70947805|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.457|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||Nasal length||||0.457
70947806|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.565|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||Nasal tip protrusion||||0.565
70947807|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.781|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||nasal width||||0.781
70947808|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.164|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||alar base width||||0.164
70947809|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.554|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||R nostril show vertical dimension||||0.554
70947810|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.508|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||L nostril show vertical dimension||||0.508
70947811|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.358|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||columellar length||||0.358
70947812|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||cutaneous height of upper lip||||0.049
70947813|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||overall upper lip height||||0.057
70947814|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.062|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||vermillion height of upper lip||||0.062
70947815|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||lower prolabial width||||0.029
70947816|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||upper lip protrusion||||0.011
70947817|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.211|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||intercanthal distance||||0.211
71133701|NCT03777059|141770122|SUPERIORITY||Least Squares Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|0.251|<|0.0001|TWO_SIDED|95.0|-1.82|-0.83||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.83|-1.82|<.0001
71133702|NCT03777059|141770122|SUPERIORITY||Least Squares Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.252|<|0.0001|TWO_SIDED|95.0|-2.0|-1.01||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-1.01|-2.00|<.0001
70947818|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.102|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||nasal height||||0.102
70947819|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.136|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||nasal length||||0.136
71133703|NCT03777059|141770123|SUPERIORITY||Odds Ratio (OR)|3.06|||<|0.0001|TWO_SIDED|95.0|2.05|4.56||Odds ratio and p-value was based on logistic regression with treatment group, Baseline value, and prior exposure to a migraine prevention medications with proven efficacy as explanatory variables.|Regression, Logistic|||||4.56|2.05|<.0001
71133704|NCT03777059|141770123|SUPERIORITY||Odds Ratio (OR)|3.53|||<|0.0001|TWO_SIDED|95.0|2.37|5.26||Odds ratio and p-value was based on logistic regression with treatment group, Baseline value, and prior exposure to a migraine prevention medications with proven efficacy as explanatory variables.|Regression, Logistic|||||5.26|2.37|<.0001
71133705|NCT03777059|141770123|SUPERIORITY||Odds Ratio (OR)|3.82|||<|0.0001|TWO_SIDED|95.0|2.56|5.71||Odds ratio and p-value was based on logistic regression with treatment group, Baseline value, and prior exposure to a migraine prevention medications with proven efficacy as explanatory variables.|Regression, Logistic|||||5.71|2.56|<.0001
71133706|NCT03777059|141770124|SUPERIORITY||Least Squares Mean Difference|9.9|STANDARD_ERROR_OF_MEAN|2.27|<|0.0001|TWO_SIDED|95.0|5.45|14.36||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||14.36|5.45|<.0001
71133707|NCT03777059|141770124|SUPERIORITY||Least Squares Mean Difference|10.08|STANDARD_ERROR_OF_MEAN|2.229|<|0.0001|TWO_SIDED|95.0|5.71|14.46||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||14.46|5.71|<.0001
71133708|NCT03777059|141770124|SUPERIORITY||Least Squares Mean Difference|10.8|STANDARD_ERROR_OF_MEAN|2.231|<|0.0001|TWO_SIDED|95.0|6.42|15.18||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||15.18|6.42|<.0001
71133709|NCT03777059|141770125|SUPERIORITY||Least Squares Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|0.693||0.0856|TWO_SIDED|95.0|-2.56|0.17||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||0.17|-2.56|0.0856
71133710|NCT03777059|141770125|SUPERIORITY||Least Squares Mean Difference|-2.54|STANDARD_ERROR_OF_MEAN|0.694||0.0003|TWO_SIDED|95.0|-3.91|-1.18||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-1.18|-3.91|0.0003
71133711|NCT03777059|141770125|SUPERIORITY||Least Squares Mean Difference|-3.32|STANDARD_ERROR_OF_MEAN|0.694|<|0.0001|TWO_SIDED|95.0|-4.68|-1.96||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-1.96|-4.68|<.0001
71133712|NCT03777059|141770126|SUPERIORITY||Least Squares Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.605||0.0743|TWO_SIDED|95.0|-2.27|0.11||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||0.11|-2.27|0.0743
71133713|NCT03777059|141770126|SUPERIORITY||Least Squares Mean Difference|-1.99|STANDARD_ERROR_OF_MEAN|0.606||0.0011|TWO_SIDED|95.0|-3.18|-0.8||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.80|-3.18|0.0011
71133714|NCT03777059|141770126|SUPERIORITY||Least Squares Mean Difference|-2.46|STANDARD_ERROR_OF_MEAN|0.605|<|0.0001|TWO_SIDED|95.0|-3.65|-1.28||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-1.28|-3.65|<.0001
71133715|NCT02813889|141770127|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-0.0146||||0.0054|TWO_SIDED|95.0|-0.0261|-0.0031||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length (Full-Term) - Path Length (Pre-Term)|||-0.0031|-0.0261|0.0054
71133716|NCT02813889|141770128|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-0.02||||0.0005|TWO_SIDED|95.0|-0.0331|-0.007||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length (Full-Term) - Path Length (Pre-Term)|||-0.0070|-0.0331|0.0005
71133717|NCT02813889|141770129|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-0.0146||||0.0088|TWO_SIDED|95.0|-0.0267|-0.0026||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length (Full-Term) - Path Length (Pre-Term)|||-0.0026|-0.0267|0.0088
71133718|NCT02813889|141770130|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-0.0059||||0.7624|TWO_SIDED|95.0|-0.018|0.0062||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length (Full-Term) - Path Length (Pre-Term)|||0.0062|-0.0180|0.7624
70861439|NCT03607422|141209174|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes only.|Least Squares (LS) Mean Difference|-49.45|STANDARD_ERROR_OF_MEAN|3.364|<|0.001|TWO_SIDED|95.0|-56.05|-42.84|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-42.84|-56.05|<0.001
70861440|NCT03607422|141209174|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-34.16|STANDARD_ERROR_OF_MEAN|3.386|<|0.001|TWO_SIDED|95.0|-40.81|-27.51|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-27.51|-40.81|<0.001
70861441|NCT03607422|141209175|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-50.14|STANDARD_ERROR_OF_MEAN|3.127|<|0.001|TWO_SIDED|95.0|-56.28|-44.0|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-44.00|-56.28|<0.001
70861442|NCT03607422|141209175|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-39.62|STANDARD_ERROR_OF_MEAN|3.139|<|0.001|TWO_SIDED|95.0|-45.79|-33.46|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-33.46|-45.79|<0.001
70861443|NCT03607422|141209176|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|54.7|||<|0.001|TWO_SIDED|95.0|47.7|61.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||61.7|47.7|<0.001
70861444|NCT03607422|141209176|SUPERIORITY||Adjusted Response Rate Difference|42.1|||<|0.001|TWO_SIDED|95.0|34.5|49.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.||49.8|34.5|<0.001
70861445|NCT03607422|141209177|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|49.0|||<|0.001|TWO_SIDED|95.0|41.4|56.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||56.5|41.4|<0.001
70861446|NCT03607422|141209177|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|42.8||||0.002|TWO_SIDED|95.0|35.0|50.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||50.6|35.0|0.002
70872129|NCT02155608|141229496|SUPERIORITY|||||||0.22|||||||Mixed Models Analysis|Group \* time: F = 1.56; df = 1/58.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parametrized in the model as a standard linear viable, time (ranging from baseline to 4 weeks) and a second variable, time2. defined as 0 at baseline and time past week 1 for subsequent weeks. The time 2 coefficient represents the change in slope after the initial week.||||.22
71133719|NCT02813889|141770131|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.0129||||0.0326|TWO_SIDED|95.0|0.0007|0.0251||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length per second (Typical) - Path Length per second (Atypical)|||0.0251|0.0007|0.0326
70861447|NCT03607422|141209178|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-40.01|STANDARD_ERROR_OF_MEAN|2.949|<|0.001|TWO_SIDED|95.0|-45.8|-34.22|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-34.22|-45.80|<0.001
70872130|NCT02155608|141229496|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|Group: F = 1.72, df = 1/12.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.21
70947820|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.113|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||nasal tip protrusion||||0.113
70947821|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.115|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||nasal width||||0.115
70872131|NCT02155608|141229496|SUPERIORITY|||||||1||||||Test not valid due to insufficient data.|Mixed Models Analysis|Time: F = 0.00, df = 1/0.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||1
70947822|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.535|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||alar base width||||0.535
70872132|NCT02155608|141229496|SUPERIORITY|||||||1||||||Test not valid due to insufficient data.|Mixed Models Analysis|Group \* time: F = .87, df = 1/0.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||1
70947823|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||R nostril show vertical dimension||||0.850
70947824|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.891|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||L nostril show vertical dimension||||0.891
70947825|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.262|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||columellar length||||0.262
70947826|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.344|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||cutaneous height of upper lip||||0.344
71133720|NCT02813889|141770132|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.0309|||<|0.0001|TWO_SIDED|95.0|0.0138|0.048||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length per second (Typical) - Path Length per second (Atypical)|||0.0480|0.0138|<0.0001
71133721|NCT02813889|141770133|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.017||||0.0025|TWO_SIDED|95.0|0.0045|0.0295||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length per second (Typical) - Path Length per second (Atypical)|||0.0295|0.0045|0.0025
71133722|NCT02813889|141770134|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.0066||||0.6782|TWO_SIDED|95.0|-0.0059|0.0191||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length per second (Typical) - Path Length per second (Atypical)|||0.0191|-0.0059|0.6782
71133723|NCT02813889|141770135|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|1.064||||0.0479|TWO_SIDED|95.0|0.006|2.122||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Full-Term) - StdDevY (Pre-Term)|||2.122|0.006|0.0479
71133724|NCT02813889|141770136|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.278||||0.9947|TWO_SIDED|95.0|-0.921|1.477||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Full-Term) - StdDevY (Pre-Term)|||1.477|-0.921|0.9947
71133725|NCT02813889|141770137|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.835||||0.2614|TWO_SIDED|95.0|-0.274|1.945||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Full-Term) - StdDevY (Pre-Term)|||1.945|-0.274|0.2614
71133726|NCT02813889|141770138|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|1.176||||0.0314|TWO_SIDED|95.0|0.066|2.286||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Full-Term) - StdDevY (Pre-Term)|||2.286|0.066|0.0314
71133727|NCT02813889|141770139|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-1.074||||0.0958|TWO_SIDED|95.0|-2.255|0.1059||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Typical) - StdDevY (Atypical)|||0.1059|-2.255|0.0958
71133728|NCT02813889|141770140|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.5248||||0.966|TWO_SIDED|95.0|-1.1243|2.1739||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Typical) - StdDevY (Atypical)|||2.1739|-1.1243|0.9660
71133729|NCT02813889|141770141|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-0.4198||||0.9462|TWO_SIDED|95.0|-1.6278|0.7882||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Typical) - StdDevY (Atypical)|||0.7882|-1.6278|0.9462
71133730|NCT02813889|141770142|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-1.0705||||0.1129|TWO_SIDED|95.0|-2.2785|0.1375||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Typical) - StdDevY (Atypical)|||0.1375|-2.2785|0.1129
71133731|NCT01101035|141770171|NON_INFERIORITY|Noninferiority was declared if the upper 1-sided CI for the hazard ratio was less than 1.3. Critical boundary of 2.359 (75% interim) based on the Lan-DeMets-O'Brien-Fleming alpha spending function was used for CI estimation.|Cox Proportional Hazard|0.99|||||ONE_SIDED|97.0||1.23|||||Time from randomization to the first occurrence of any MACE was fitted using Cox Proportional Hazard model with treatment as a covariate and Baseline renal function as a stratification factor.|Statistical analysis for the primary endpoint was based on 1-sided repeated confidence intervals (CIs), using critical values from a 1-sided stopping boundary for a group sequential design (GSD), to preserve an overall false-rejection rate of 2.5%, to assess non-inferiority at each interim analysis and the final analysis.||1.23||
71133732|NCT01101035|141770172|OTHER||Cox Proportional Hazard|1.09|||||TWO_SIDED|95.0|0.92|1.28|||||Time from randomization to the first occurrence of any APTC event was fitted using Cox Proportional Hazard model with treatment as a covariate and Baseline renal function status as a stratification factor.|||1.28|0.92|
71133733|NCT01101035|141770173|OTHER||Cox Proportional Hazard|1.34|||||TWO_SIDED|95.0|1.03|1.73|||||Time from randomization to the first occurrence of cardiovascular death was fitted using Cox Proportional Hazard model with factors including treatment and baseline renal function.|||1.73|1.03|
71133734|NCT01101035|141770174|OTHER||Cox Proportional Hazard|0.93|||||TWO_SIDED|95.0|0.72|1.21|||||Time from randomization to the first occurrence of non-fatal MI was fitted using Cox Proportional Hazard model with factors including treatment and baseline renal function.|||1.21|0.72|
71133735|NCT01101035|141770175|OTHER||Cox Proportional Hazard|1.01|||||TWO_SIDED|95.0|0.73|1.41|||||Time from randomization to the first occurrence of non-fatal stroke was fitted using Cox Proportional Hazard model with factors including treatment and baseline renal function.|||1.41|0.73|
71133736|NCT01101035|141770176|OTHER||Cox Proportional Hazard|0.86|||||TWO_SIDED|95.0|0.59|1.26|||||Time from randomization to the first occurrence of unstable angina with urgent coronary revascularization was fitted using Cox Proportional Hazard model with factors including treatment and baseline renal function.|||1.26|0.59|
71133737|NCT01101035|141770177|NON_INFERIORITY|Noninferiority was declared if the upper 1-sided CI for the hazard ratio was less than 1.3. Critical boundary of 2.014 (final analysis) based on the Lan-DeMets-O'Brien-Fleming alpha spending function was used for CI estimation.|Cox Proportional Hazard|1.03|||||TWO_SIDED|97.0|0.87|1.23|||||Time from randomization to the first occurrence of any MACE was fitted using Cox Proportional Hazard model with treatment as a covariate and Baseline renal function as a stratification factor.|Statistical analysis for the primary endpoint was based on 1-sided repeated confidence intervals (CIs), using critical values from a 1-sided stopping boundary for a group sequential design (GSD), to preserve an overall false-rejection rate of 2.5%, to assess non-inferiority at each interim analysis and the final analysis.||1.23|0.87|
71133738|NCT01173601|141770204|SUPERIORITY_OR_OTHER|||||||0.338||||||In order to test the primary outcome between each LY2216684 dose and placebo while controlling the overall Type I error at 0.05, the significance level was a priori partitioned equally between the 2 LY2216684 dose-placebo comparisons at 0.025.|Mixed Models Analysis|||||||0.338
71133739|NCT01173601|141770204|SUPERIORITY_OR_OTHER|||||||0.201||||||In order to test the primary outcome between each LY2216684 dose and placebo while controlling the overall Type I error at 0.05, the significance level was a priori partitioned equally between the 2 LY2216684 dose-placebo comparisons at 0.025.|Mixed Models Analysis|||||||0.201
71133740|NCT03951077|141770225|SUPERIORITY||Adjusted Response Rate Difference|-5.9||||0.3|TWO_SIDED|90.0|-15.38|3.49|||Cochran-Mantel-Haenszel|||Across the strata, 90% confidence interval (CI) for adjusted difference and p-value were calculated according to the Cochran-Mantel-Haenszel (CMH) test adjusted for strata (Baseline FG score \[\< 8, ≥ 8\], and baseline normal/obese status \[BMI \< 30, ≥ 30\]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.||3.49|-15.38|0.300
71133741|NCT03951077|141770225|SUPERIORITY||Adjusted Response Rate Difference|-5.9||||0.32|TWO_SIDED|90.0|-15.65|3.86|||Cochran-Mantel-Haenszel|||Across the strata, 90% CI for adjusted difference and p-value were calculated according to the CMH test adjusted for strata (Baseline FG score \[\< 8, ≥ 8\], and baseline normal/obese status \[BMI \< 30, ≥ 30\]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.||3.86|-15.65|0.320
71133742|NCT03951077|141770225|SUPERIORITY||Adjusted Response Rate Difference|-5.6||||0.315|TWO_SIDED|90.0|-14.87|3.59|||Cochran-Mantel-Haenszel|||Across the strata, 90% CI for adjusted difference and p-value were calculated according to the CMH test adjusted for strata (Baseline FG score \[\< 8, ≥ 8\], and baseline normal/obese status \[BMI \< 30, ≥ 30\]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.||3.59|-14.87|0.315
71133743|NCT03951077|141770225|SUPERIORITY||Adjusted Response Rate Difference|-6.7||||0.265|TWO_SIDED|90.0|-16.63|3.19|||Cochran-Mantel-Haenszel|||Across the strata, 90% CI for adjusted difference and p-value were calculated according to the CMH test adjusted for strata (Baseline FG score \[\< 8, ≥ 8\], and baseline normal/obese status \[BMI \< 30, ≥ 30\]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.||3.19|-16.63|0.265
71133744|NCT03951077|141770225|SUPERIORITY||Adjusted Response Rate Difference|-0.8||||0.914|TWO_SIDED|90.0|-13.1|11.48|||Cochran-Mantel-Haenszel|||Across the strata, 90% CI for adjusted difference and p-value were calculated according to the CMH test adjusted for strata (Baseline FG score \[\< 8, ≥ 8\], and baseline normal/obese status \[BMI \< 30, ≥ 30\]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.||11.48|-13.10|0.914
71133745|NCT03951077|141770226|SUPERIORITY||Least Squares (LS) Mean of Difference|-5.93|STANDARD_ERROR_OF_MEAN|3.429||0.087|TWO_SIDED|90.0|-11.628|-0.231|||MMRM|||P-value is from mixed-effect model repeated measure (MMRM) with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (\< 8, ≥ 8), and baseline normal/obese status (BMI \< 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.||-0.231|-11.628|0.087
70861448|NCT03607422|141209178|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-29.47|STANDARD_ERROR_OF_MEAN|2.941|<|0.001|TWO_SIDED|95.0|-35.24|-23.69|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.||||-23.69|-35.24|<0.001
71133746|NCT03951077|141770226|SUPERIORITY||LS Mean of Difference|-8.83|STANDARD_ERROR_OF_MEAN|3.435||0.012|TWO_SIDED|90.0|-14.533|-3.118|||MMRM|||P-value is from MMRM with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (\< 8, ≥ 8), and baseline normal/obese status (BMI \< 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.||-3.118|-14.533|0.012
71133747|NCT03951077|141770226|SUPERIORITY||LS Mean of Difference|-16.1|STANDARD_ERROR_OF_MEAN|3.356|<|0.001|TWO_SIDED|90.0|-21.673|-10.519|||MMRM|||P-value is from MMRM with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (\< 8, ≥ 8), and baseline normal/obese status (BMI \< 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.||-10.519|-21.673|<0.001
71133748|NCT03951077|141770226|SUPERIORITY||LS Mean of Difference|-6.15|STANDARD_ERROR_OF_MEAN|3.593||0.091|TWO_SIDED|90.0|-12.116|-0.176|||MMRM|||P-value is from MMRM with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (\< 8, ≥ 8), and baseline normal/obese status (BMI \< 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.||-0.176|-12.116|0.091
70947827|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||overall upper lip height||||0.057
71133749|NCT03951077|141770226|SUPERIORITY||LS Mean of Difference|-11.72|STANDARD_ERROR_OF_MEAN|3.431|<|0.001|TWO_SIDED|90.0|-17.418|-6.016|||MMRM|||P-value is from MMRM with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (\< 8, ≥ 8), and baseline normal/obese status (BMI \< 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.||-6.016|-17.418|< 0.001
71133750|NCT01395901|141770228|NON_INFERIORITY_OR_EQUIVALENCE|For the primary efficacy analysis, the confidence interval (CI) was built on the FAS using the stratum adjusted Mantel-Haenszel (MH) method with correction of continuity. The non-inferiority margin was -10%.|Risk Difference (RD)|-4.4|||||TWO_SIDED|95.0|-10.5|1.7||||||"The null hypothesis (H0) was stated as:~• H0 : CR 0-24 hr palonosetron - CR 0-24 hr ondansetron \<-10%~The alternative hypothesis (H1) was stated as:~• H1 : CR 0-24 hr palonosetron - CR 0-24 hr ondansetron \>-10%~A power of 80% was used for sample size computation."||1.7|-10.5|
71133751|NCT02178995|141770282|SUPERIORITY_OR_OTHER|||||||0.037||||||HRTSD p-value = 0.037; p \< 0.05 considered significant|ANOVA|Within-subjects contrasts, n=31, df=1||||||0.037
71133752|NCT02178995|141770282|SUPERIORITY_OR_OTHER|||||||0.055||||||D' p = 0.055. p \< 0.05 considered significant.|ANOVA|Within-subjects contrasts, placebo v 10mg v 20mg.||||||0.055
71133753|NCT02178995|141770282|SUPERIORITY_OR_OTHER|||||||0.758|||||||t-test, 2 sided|||HRTSD 10mg vs 20mg||||0.758
71133754|NCT02178995|141770282|SUPERIORITY_OR_OTHER|||||||0.499|||||||t-test, 2 sided|||d' 10mg vs 20mg||||0.499
71133755|NCT02178995|141770283|SUPERIORITY_OR_OTHER|||||||0.008|||||||ANOVA|||||||0.008
71133756|NCT02178995|141770283|SUPERIORITY_OR_OTHER|||||||0.071|||||||t-test, 2 sided|||SDMT 10mg vs 20mg||||0.071
71133757|NCT02178995|141770284|SUPERIORITY_OR_OTHER|||||||0.154|||||||ANOVA|||||||0.154
71133758|NCT02178995|141770284|SUPERIORITY_OR_OTHER|||||||0.779|||||||t-test, 2 sided|||MCG 10mg vs 20mg||||0.779
71133759|NCT02178995|141770285|SUPERIORITY_OR_OTHER||||||<|0.0001||||||HRTSD P\<0.0001|t-test, 2 sided|||Intra-group comparison, HRTSD||||<0.0001
71133760|NCT02178995|141770285|SUPERIORITY_OR_OTHER|||||||0.001||||||HRTSD p \<0.001 for healthy controls|t-test, 2 sided|||Intra-group comparison, HRTSD, healthy controls||||0.001
71133761|NCT02178995|141770285|SUPERIORITY_OR_OTHER|||||||0.322|||||||ANOVA|||Between-group comparisons by 2-way ANOVA, HRTSD||||0.322
71133762|NCT02178995|141770285|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Intra-group comparison, epilepsy, D'||||<0.0001
71133763|NCT02178995|141770285|SUPERIORITY_OR_OTHER|||||||0.037|||||||t-test, 2 sided|||Intra-group analysis, healthy controls, d'||||0.037
71133764|NCT02178995|141770285|SUPERIORITY_OR_OTHER|||||||0.08|||||||ANOVA|||Intra-group analysis by 2-way ANOVA, d'||||0.08
71133765|NCT02178995|141770286|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
71133766|NCT02178995|141770286|SUPERIORITY_OR_OTHER|||||||0.022|||||||t-test, 2 sided|||||||0.022
71133767|NCT02178995|141770286|SUPERIORITY_OR_OTHER|||||||0.443|||||||ANOVA|||Group x time interaction by 2-way ANOVA||||0.443
71133768|NCT02178995|141770287|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71133769|NCT02178995|141770287|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||||||0.004
71133770|NCT02178995|141770287|SUPERIORITY_OR_OTHER|||||||0.906|||||||ANOVA|||Between-groups analysis by 2-way ANOVA||||0.906
71133771|NCT02178995|141770288|SUPERIORITY_OR_OTHER|||||||0.274|||||||t-test, 2 sided|||||||0.274
71133772|NCT02178995|141770289|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71133773|NCT02178995|141770290|SUPERIORITY_OR_OTHER|||||||0.04||||||Hits p = 0.04|ANOVA|||||||0.04
71133774|NCT02178995|141770290|SUPERIORITY_OR_OTHER|||||||0.038||||||Omissions p = 0.038|ANOVA|||||||0.038
71133775|NCT02178995|141770290|SUPERIORITY_OR_OTHER|||||||0.329||||||Commissions p = 0.329|ANOVA|||||||0.329
71133776|NCT02178995|141770290|SUPERIORITY_OR_OTHER|||||||0.876|||||||t-test, 2 sided|||Hits 10mg vs 20mg||||0.876
71133777|NCT02178995|141770290|SUPERIORITY_OR_OTHER|||||||0.932|||||||t-test, 2 sided|||Omissions 10mg vs 20mg||||0.932
70947828|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.995|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||vermillion height of upper lip||||0.995
71133778|NCT02178995|141770290|SUPERIORITY_OR_OTHER|||||||0.898|||||||t-test, 2 sided|||Commissions 10mg vs 20mg||||0.898
71133779|NCT02178995|141770291|SUPERIORITY_OR_OTHER|||||||0.7116|||||||t-test, 2 sided|||Comparison of baseline rate of seizures (expressed as seizures per 28 days) pre-trial against the rate experienced during the double-blind portion of our trial.||||0.7116
71133780|NCT02178995|141770292|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Attention/Concentration subscale||||<0.0001
71133781|NCT02178995|141770292|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Memory subscale||||<0.0001
71133782|NCT02178995|141770292|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Language subscale||||0.002
71133783|NCT02178995|141770292|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||Energy/fatigue subscale||||0.001
71133784|NCT02178995|141770293|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 2 sided|||Hits v1 vs v5 epilepsy||||0.003
71133785|NCT02178995|141770293|SUPERIORITY_OR_OTHER|||||||0.033|||||||t-test, 2 sided|||Hits v1 vs v5 healthy||||0.033
71133786|NCT02178995|141770293|SUPERIORITY_OR_OTHER|||||||0.079|||||||ANOVA|||2-way ANOVA epilepsy vs healthy hits||||0.079
71133787|NCT02178995|141770293|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||Omissions epilepsy v1 vs v5||||0.001
71133788|NCT02178995|141770293|SUPERIORITY_OR_OTHER|||||||0.029|||||||t-test, 2 sided|||Omissions v1 vs v5 healthy||||0.029
71133789|NCT02178995|141770293|SUPERIORITY_OR_OTHER|||||||0.048|||||||t-test, 2 sided|||Epilepsy v healthy ANOVA Omissions||||0.048
71133790|NCT02178995|141770293|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Commissions v1 vs v5 epilepsy||||<0.0001
71133791|NCT02178995|141770293|SUPERIORITY_OR_OTHER|||||||0.42|||||||t-test, 2 sided|||Commissions v1 vs v5 healthy||||0.42
71133792|NCT02178995|141770293|SUPERIORITY_OR_OTHER|||||||0.019|||||||ANOVA|||Healthy vs epilepsy ANOVA (2-way) commissions||||0.019
71133793|NCT02178995|141770294|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71133794|NCT02178995|141770295|SUPERIORITY_OR_OTHER|||||||0.003||||||Note: Stimulant side-effect score \*decreased\* with addition of open-label stimulant.|t-test, 2 sided|||||||0.003
71133795|NCT02178995|141770296|SUPERIORITY_OR_OTHER|||||||0.014|||||||t-test, 2 sided|||BDI epilepsy v1 vs v5||||0.014
71133796|NCT02178995|141770296|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||Healthy controls BDI v1 vs v5||||0.04
71133797|NCT02178995|141770296|SUPERIORITY_OR_OTHER|||||||0.191|||||||t-test, 2 sided|||Between-group comparison 2-way ANOVA BDI||||0.191
71133798|NCT02178995|141770296|SUPERIORITY_OR_OTHER|||||||0.42|||||||t-test, 2 sided|||BAI visit 1 vs visit 5 epilepsy||||0.42
71133799|NCT02178995|141770296|SUPERIORITY_OR_OTHER|||||||0.477|||||||t-test, 2 sided|||BAI visit 1 vs visit 5 healthy controls||||0.477
71133800|NCT02178995|141770296|SUPERIORITY_OR_OTHER|||||||0.792|||||||ANOVA|||Between-groups comparison 2-way ANOVA BAI||||0.792
70947829|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||lower prolabial width||||0.440
70947830|NCT01473745|141396633|SUPERIORITY_OR_OTHER|||||||0.078|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||upper lip protrusion||||0.078
71133801|NCT02178995|141770296|SUPERIORITY_OR_OTHER|||||||0.045|||||||t-test, 2 sided|||AES visit 1 vs visit 5 epilepsy||||0.045
71133802|NCT02178995|141770296|SUPERIORITY_OR_OTHER|||||||0.646|||||||t-test, 2 sided|||AES visit 1 vs visit 5 healthy controls||||0.646
71133803|NCT02178995|141770296|SUPERIORITY_OR_OTHER|||||||0.222|||||||ANOVA|||Between-groups comparison 2-way ANOVA AES||||0.222
71133804|NCT02178995|141770297|SUPERIORITY_OR_OTHER|||||||0.011|||||||t-test, 2 sided|||Health Perceptions||||0.011
71133805|NCT02178995|141770297|SUPERIORITY_OR_OTHER|||||||0.01|||||||t-test, 2 sided|||Overall QOL (subjectively rated by participants on the scale)||||0.01
71133806|NCT02178995|141770297|SUPERIORITY_OR_OTHER|||||||0.164|||||||t-test, 2 sided|||Physical Function||||0.164
71133807|NCT02178995|141770297|SUPERIORITY_OR_OTHER|||||||0.065|||||||t-test, 2 sided|||Role Limitations (Emotional)||||0.065
71133808|NCT02178995|141770297|SUPERIORITY_OR_OTHER|||||||0.014|||||||t-test, 2 sided|||Role Limitations (Physical)||||0.014
71133809|NCT02178995|141770297|SUPERIORITY_OR_OTHER|||||||0.128|||||||t-test, 2 sided|||Pain||||0.128
70872133|NCT03808493|141229518|EQUIVALENCE|For log-transformed (natural log) AUClast, the two-sided 90% CI of the difference in the least square means (LS-Means) between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|-0.0211|||||TWO_SIDED|90.0|-0.0752|0.0329||||||||0.0329|-0.0752|
70947831|NCT01473745|141396634|SUPERIORITY_OR_OTHER|||||||0.104|TWO_SIDED|||||intergroup difference of conventional group|t-test, 2 sided|P value \< 0.05 was set as statistical significance.||||||0.104
70947832|NCT01473745|141396634|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED|||||Intergroup difference of modified group|t-test, 2 sided|P value \<0.05 was set as statistical significance.||||||0.043
71133810|NCT02178995|141770297|SUPERIORITY_OR_OTHER|||||||0.026|||||||t-test, 2 sided|||Work/Driving/Social||||0.026
71133811|NCT02178995|141770297|SUPERIORITY_OR_OTHER|||||||0.077|||||||t-test, 2 sided|||Emotional Wellbeing||||0.077
71133812|NCT02178995|141770297|SUPERIORITY_OR_OTHER|||||||0.007|||||||t-test, 2 sided|||Health Discouragement||||0.007
71133813|NCT02178995|141770297|SUPERIORITY_OR_OTHER|||||||0.063|||||||t-test, 2 sided|||Seizure Worry||||0.063
71133814|NCT02178995|141770297|SUPERIORITY_OR_OTHER|||||||0.609|||||||t-test, 2 sided|||Medication Effects||||0.609
71133815|NCT02178995|141770297|SUPERIORITY_OR_OTHER|||||||0.626|||||||t-test, 2 sided|||Social Support||||0.626
71133816|NCT02178995|141770297|SUPERIORITY_OR_OTHER|||||||0.103|||||||t-test, 2 sided|||Social Isolation||||0.103
71133817|NCT02178995|141770298|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Variability v1 vs v5 epilepsy||||<0.0001
71133818|NCT02178995|141770298|SUPERIORITY_OR_OTHER|||||||0.096|||||||t-test, 2 sided|||Variability v1 vs v5 healthy||||0.096
71133819|NCT02178995|141770298|SUPERIORITY_OR_OTHER|||||||0.136|||||||ANOVA|||Variability 2-way ANOVA healthy vs epilepsy||||0.136
71133820|NCT02178995|141770298|SUPERIORITY_OR_OTHER|||||||0.17|||||||t-test, 2 sided|||Perseverations v1 vs v5 epilepsy||||0.17
71133821|NCT02178995|141770298|SUPERIORITY_OR_OTHER|||||||0.104|||||||t-test, 2 sided|||Perseverations v1 vs v5 healthy||||0.104
71133822|NCT02178995|141770298|SUPERIORITY_OR_OTHER|||||||0.661|||||||ANOVA|||Perseverations 2-way ANOVA healthy vs epilepsy||||0.661
71133823|NCT02178995|141770299|SUPERIORITY_OR_OTHER|||||||0.397|||||||ANOVA|||Variability ANOVA||||0.397
71133824|NCT02178995|141770299|SUPERIORITY_OR_OTHER|||||||0.745|||||||ANOVA|||Perseverations ANOVA||||0.745
71133825|NCT02178995|141770299|SUPERIORITY_OR_OTHER|||||||0.362|||||||t-test, 2 sided|||10mg vs 20mg variability||||0.362
71133826|NCT02178995|141770299|SUPERIORITY_OR_OTHER|||||||0.745|||||||t-test, 2 sided|||10mg vs 20mg perseverations||||0.745
71133827|NCT02178995|141770300|SUPERIORITY_OR_OTHER|||||||0.48|||||||ANOVA|||HRT ANOVA||||0.48
71133828|NCT02178995|141770300|SUPERIORITY_OR_OTHER|||||||0.793|||||||t-test, 2 sided|||HRT 10mg vs 20mg||||0.793
71133829|NCT02178995|141770301|SUPERIORITY_OR_OTHER|||||||0.5|||||||t-test, 2 sided|||HRT v1 vs v5 epilepsy||||0.5
71133830|NCT02178995|141770301|SUPERIORITY_OR_OTHER|||||||0.075|||||||t-test, 2 sided|||HRT v1 vs v5 healthy||||0.075
71133831|NCT02178995|141770301|SUPERIORITY_OR_OTHER|||||||0.2|||||||ANOVA|||HRT epilepsy vs healthy ANOVA||||0.2
71133832|NCT00587158|141770302|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||Fisher Exact|||||||0.0005
71133833|NCT00587158|141770303|SUPERIORITY_OR_OTHER|||||||0.4571||95.0|||||Fisher Exact|||||||0.4571
71133834|NCT00587158|141770304|SUPERIORITY_OR_OTHER|||||||0.229||95.0|||||Fisher Exact|||||||0.2290
71133835|NCT00587158|141770305|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Wilcoxon (Mann-Whitney)|||The median PTH level at baseline was compared between the two treatment groups.||||0.17
71133836|NCT00587158|141770305|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Wilcoxon (Mann-Whitney)|||The median PTH level at 21 days was compared between the two treatment groups.||||0.005
71133837|NCT00587158|141770305|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||The median PTH level at 90 days was compared between the two treatment groups.||||<0.0001
71133838|NCT00587158|141770305|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Wilcoxon (Mann-Whitney)|||The median PTH level at one year was compared between the two treatment groups.||||0.0004
71133839|NCT00587158|141770306|SUPERIORITY_OR_OTHER|||||||0.833||95.0|||||Wilcoxon (Mann-Whitney)|||The median BAP level at baseline was compared between the two treatment groups.||||0.833
71133840|NCT00587158|141770306|SUPERIORITY_OR_OTHER|||||||0.553||95.0|||||Wilcoxon (Mann-Whitney)|||The median BAP level at 21 days was compared between the two treatment groups.||||0.553
71133841|NCT00587158|141770306|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Wilcoxon (Mann-Whitney)|||The median BAP level at 90 days was compared between the two treatment groups.||||0.035
71133842|NCT00587158|141770306|SUPERIORITY_OR_OTHER|||||||0.171||95.0|||||Wilcoxon (Mann-Whitney)|||The median BAP level at one year was compared between the two treatment groups.||||0.171
71133843|NCT00587158|141770307|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||t-test, 2 sided|||||||0.98
71133844|NCT00587158|141770308|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||t-test, 2 sided|||||||0.41
71133845|NCT00587158|141770311|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||t-test, 2 sided|||||||0.66
71133846|NCT00587158|141770312|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||t-test, 2 sided|||||||0.66
71133847|NCT00587158|141770313|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||t-test, 2 sided|||||||0.11
71133848|NCT00587158|141770314|SUPERIORITY_OR_OTHER|||||||1||95.0|||||t-test, 2 sided|||The number of subjects with mild interstitial fibrosis (Banff ci score \> 0 and \< 2) at one year was compared between treatment groups.||||1.0
71133849|NCT00587158|141770314|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||t-test, 2 sided|||The number of subjects with moderate to mild interstitial fibrosis (Banff ci score greater than or equal to 2) at one year was compared between treatment groups.||||0.04
71133850|NCT05258149|141770315|SUPERIORITY|A superiority margin of 1 was used.|Odds Ratio (OR)|1.65|||||TWO_SIDED|95.0|1.1|2.46|||Generalized Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Odds Ratio was calculated as senofilcon A C3 over delefilcon A|||2.46|1.10|
71133851|NCT05258149|141770316|SUPERIORITY|A superiority margin of 1 was used.|Odds Ratio (OR)|1.88|||||TWO_SIDED|95.0|1.27|2.79|||Generalized Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Odds Ratio was calculated as senofilcon A C3 over delefilcon A|||2.79|1.27|
71133852|NCT05258149|141770317|NON_INFERIORITY|A Non-Inferiority margin of 10% was used.|Odds Ratio (OR)|0.74|||||TWO_SIDED|98.33|0.42|1.3|||Generalized Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Odds Ratio was calculated as senofilcon A C3 over delefilcon A||confidence intervals were adjusted using 98.33% per each secondary endpoint|1.30|0.42|
71133853|NCT05258149|141770318|SUPERIORITY|A superiority margin of 1 was used.|Odds Ratio (OR)|1.58|||||TWO_SIDED|98.33|0.91|2.75|||Generalized Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Odds Ratio was calculated as senofilcon A C3 over delefilcon A||confidence intervals were adjusted using 98.33% per each secondary endpoint|2.75|0.91|
71133854|NCT05258149|141770319|SUPERIORITY|A superiority margin of 1 was used.|Odds Ratio (OR)|2.08|||||TWO_SIDED|98.33|1.24|3.5|||Generalized Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Odds Ratio was calculated as senofilcon A C3 over delefilcon A||confidence intervals were adjusted using 98.33% per each secondary endpoint|3.50|1.24|
71133855|NCT02114606|141770329|OTHER|Overall agreement was calculated using Cohen's Kappa, with endoscopic biopsy as the gold standard.||||||0.0001||||||A p-value of \<0.05 was considered statistically significant.|Cohen's Kappa|||All participants enrolled (EoE Patients) provided both a Cytosponge specimen and endoscopic biopsy. The results of these specimens were compared to examine overall agreement.||||0.0001
71133856|NCT03187119|141770334|SUPERIORITY||Slope|1.41||||0.42|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction.|linear mixed model|||The reference group for this model is the Pictorial Asthma Action Plan Group.||||0.42
71133857|NCT03187119|141770334|SUPERIORITY||Slope|-14.31||||0.03|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effect of time and the time x group interaction.|multiple linear regression.|||The reference group for this analysis is the Pictorial Asthma Action Plan group.||||0.03
71133858|NCT03187119|141770334|SUPERIORITY||Slope|-0.33||||0.89|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 1 and 2 for the main effects of group and time.|multiple linear regression.|||The reference group for this analysis is the Pictorial Asthma Action Plan group.||||0.89
71133859|NCT03187119|141770335|SUPERIORITY||Slope|-1.59||||0.31|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction.|multiple linear regression.|||The reference group for this analysis is the Pictorial Asthma Action Plan group.||||0.31
71133860|NCT03187119|141770335|SUPERIORITY||Slope|1.9||||0.73|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effect of time and the time x group interaction.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.73
71133861|NCT03187119|141770335|SUPERIORITY||Slope|-0.21||||0.92|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 1 and 2 for the main effects of group and time.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.92
71133862|NCT03187119|141770336|SUPERIORITY||Slope|0.52||||0.06|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction.|generalized linear mixed model|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.06
70947833|NCT01473745|141396634|SUPERIORITY_OR_OTHER|||||||0.888|TWO_SIDED||||||t-test, 2 sided|P value \< 0.05 was set as statistical significance.||||||0.888
71133863|NCT03187119|141770336|SUPERIORITY||Slope|-1.57||||0.07|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 2 for the main effect of group and the time x group interaction.|generalized linear mixed model|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.07
70947834|NCT02366143|141396649|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.52|0.74|||Log Rank|||ITT-WT population||0.74|0.52|<0.0001
71133864|NCT03187119|141770336|SUPERIORITY||Slope|0.37||||0.33|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 2 and 3 for the main effects of group and time.|generalized linear mixed model|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.33
71133865|NCT03187119|141770337|SUPERIORITY||Slope|-0.01||||0.002|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2-3 for the main effects of time and prescription and Analyses 4-6 for interactions.|generalized linear mixed model||The analyses are modeling lower adherence.|The reference group for this analysis is the Pictorial Asthma Action Plan group.||||.002
71133866|NCT03187119|141770337|SUPERIORITY||Slope|-0.16||||0.07|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effects of time and prescription and Analyses 4-6 for interactions.|generalized linear mixed model||The analyses are modeling lower adherence.|The reference group for this analysis is the Pictorial Asthma Action Plan group.||||0.07
71133867|NCT03187119|141770337|SUPERIORITY||Slope|0.43||||0.69|TWO_SIDED|||||The results listed here are for the main effect of prescription. Please see Analyses 1-2 for the main effects of time and group and Analyses 4-6 for interactions.|generalized linear mixed model||The analyses are modeling lower adherence.|The reference group for this analysis is the Pictorial Asthma Action Plan group.||||.69
71133868|NCT03187119|141770337|SUPERIORITY||Slope|0.02||||0.37|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 1-3 for the main effects of group, time and prescription and Analyses 5-7 for other interactions.|generalized linear mixed model||The analyses are modeling lower adherence.|The reference group for this analysis is the Pictorial Asthma Action Plan group.||||0.37
71133869|NCT03187119|141770337|SUPERIORITY||Slope|-1.14||||0.12|TWO_SIDED|||||The results listed here are for the prescription x group interaction. Please see Analyses 1-3 for the main effects of group, time and prescription and Analyses 4 and 6 for other interactions.|generalized linear mixed model||The analyses are modeling lower adherence.|The reference group for this analysis is the Pictorial Asthma Action Plan group.||||0.12
71133870|NCT03187119|141770337|SUPERIORITY||Slope|0.01||||0.006|TWO_SIDED|||||The results listed here are for the time x PAAP group x prescription interaction. Please see Analyses 1-3 for the main effects of group, time and prescription and Analyses 4-5 for interactions.|generalized linear mixed model||The analyses are modeling lower adherence.|The reference groups for this analysis is the 2x per day group.||||0.006
71133871|NCT03187119|141770337|SUPERIORITY||Slope|0.04||||0.006|TWO_SIDED|||||The results listed here are for the time x WAAP group x prescription interaction. Please see Analyses 1-3 for the main effects of group, time and prescription and Analyses 4-5 for interactions.|generalized linear mixed model||These analyses are modeling lower adherence.|The reference group for this analysis is 2x per day group.||||0.006
71133872|NCT03187119|141770338|SUPERIORITY||Slope|0.08||||0.18|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.18
71133873|NCT03187119|141770338|SUPERIORITY||Slope|-0.09||||0.71|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effect of time and the time x group interaction.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.71
71133874|NCT03187119|141770338|SUPERIORITY||Slope|0.007||||0.96|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 1 and 2 for the main effects of time and group.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.96
71133875|NCT03187119|141770340|SUPERIORITY||Slope|-0.02||||0.74|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.74
71133876|NCT03187119|141770340|SUPERIORITY||Slope|0.02||||0.83|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effect of time and the time x group interaction|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.83
71133877|NCT03187119|141770340|SUPERIORITY||Slope|-0.21||||0.03|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 1 and 2 for the main effects of time and group.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.03
71133878|NCT03187119|141770341|SUPERIORITY||Slope|0.12||||0.08|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.08
71133879|NCT03187119|141770341|SUPERIORITY||Slope|-0.12||||0.25|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effect of time and the time x group interaction.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.25
71133880|NCT03187119|141770341|SUPERIORITY||Slope|-0.21||||0.03|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 1 and 2 for the main effects of time and group.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.03
71133881|NCT01466127|141770346|SUPERIORITY_OR_OTHER|||||||0.28|||||||t-test, 2 sided|||||||0.28
71133882|NCT01910402|141770347|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Hypothesis was to show that the antiviral effect of the DTG/ABC/3TC FDC administered QD was non-inferior to QD ATV+RTV+TDF/FTC FDC. Non-inferiority was concluded if the lower bound of a two-sided 95% confidence interval for the difference in response rates between the two treatment arms was greater than -12%|Adjusted difference in proportion|10.5||||0.005|TWO_SIDED|95.0|3.1|17.8||If the primary and PP analyses both demonstrated non-inferiority, then as per pre-specified analysis, superiority of DTG/ABC/3TC FDC versus ATV+RTV+TDF/FTC FDC was tested in the ITT-E population at the 2-sided 5% level of significance.|Cochran-Mantel-Haenszel|||||17.8|3.1|0.005
70872134|NCT03808493|141229518|EQUIVALENCE|For log-transformed (natural log) AUClast, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.0019|||||TWO_SIDED|90.0|-0.0778|0.0815||||||||0.0815|-0.0778|
70947835|NCT02366143|141396649|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.38|0.68|||Log Rank|||Teff-high WT Population||0.68|0.38|<0.0001
71133883|NCT01910402|141770369|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.026||||0.7053|TWO_SIDED|95.0|-0.159|0.107|||Multiple Imputed Dataset - MAR|||||0.107|-0.159|0.7053
71133884|NCT01910402|141770370|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.106||||0.3165|TWO_SIDED|95.0|-0.313|0.101|||Multiple Imputed Dataset - MAR|||||0.101|-0.313|0.3165
71133885|NCT01910402|141770385|SUPERIORITY_OR_OTHER_LEGACY||Ratio of ratio|0.729|||<|0.001|TWO_SIDED|95.0|0.683|0.779|||ANCOVA||BSAP ratio of Week 48 result over Baseline|||0.779|0.683|<0.001
71133886|NCT01910402|141770385|SUPERIORITY_OR_OTHER_LEGACY||Ratio of ratio|0.693|||<|0.001|TWO_SIDED|95.0|0.647|0.741|||ANCOVA||PTP ratio of Week 48 result over Baseline|||0.741|0.647|<0.001
71133887|NCT01910402|141770385|SUPERIORITY_OR_OTHER_LEGACY||Ratio of ratio|0.629|||<|0.001|TWO_SIDED|95.0|0.581|0.68|||ANCOVA||Osteocalcin ratio of Week 48 result over Baseline|||0.680|0.581|<0.001
71133888|NCT01910402|141770385|SUPERIORITY_OR_OTHER_LEGACY||Ratio of ratio|0.655|||<|0.0001|TWO_SIDED|95.0|0.609|0.706|||ANCOVA||Type 1 Collagen C-Telopeptide ratio of Week 48 result over Baseline|||0.706|0.609|<0.0001
71133889|NCT01910402|141770385|SUPERIORITY_OR_OTHER_LEGACY||Ratio of ratio|0.852|||<|0.0001|TWO_SIDED|95.0|0.794|0.914|||ANCOVA||Vitamin D ratio of Week 48 result over Baseline|||0.914|0.794|<0.0001
71133890|NCT01910402|141770387|SUPERIORITY_OR_OTHER_LEGACY|||||||0.016||95.0||||Week 4|Wilcoxon (Mann-Whitney)|||||||0.016
71133891|NCT01910402|141770387|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Week 12|Wilcoxon (Mann-Whitney)|||||||<0.001
71133892|NCT01910402|141770387|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Week 24|Wilcoxon (Mann-Whitney)|||||||0.002
71133893|NCT01910402|141770387|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0||||Week 48|Wilcoxon (Mann-Whitney)|||||||0.007
71133894|NCT00571038|141770397|SUPERIORITY_OR_OTHER|||||||0.2417|TWO_SIDED||||||Mixed Models Analysis|||||||0.2417
71133895|NCT00571038|141770398|SUPERIORITY_OR_OTHER|||||||0.8586|TWO_SIDED||||||Mixed Models Analysis|||||||0.8586
71133896|NCT00571038|141770399|SUPERIORITY_OR_OTHER|||||||0.0432|TWO_SIDED||||||Mixed Models Analysis|||||||0.0432
71133897|NCT00571038|141770400|SUPERIORITY_OR_OTHER|||||||0.0604|TWO_SIDED||||||Mixed Models Analysis|||||||0.0604
71133898|NCT00571038|141770401|SUPERIORITY_OR_OTHER|||||||0.0438|TWO_SIDED||||||Kruskal-Wallis|||||||0.0438
70872135|NCT03808493|141229519|EQUIVALENCE|For log-transformed (natural log) Cmax, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|-0.0698|||||TWO_SIDED|90.0|-0.1404|0.0008||||||||0.0008|-0.1404|
70947836|NCT02366143|141396650|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.78||||0.0164|TWO_SIDED|95.0|0.64|0.96|||Log Rank|||||0.96|0.64|0.0164
70947837|NCT02366143|141396651|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.842||||0.0528|TWO_SIDED|95.0|0.707|1.002|||Log Rank|||||1.002|0.707|0.0528
71133899|NCT00571038|141770402|SUPERIORITY_OR_OTHER|||||||0.1418|TWO_SIDED||||||Kruskal-Wallis|||||||0.1418
71133900|NCT00571038|141770403|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Fisher Exact|Two-sided Pr \<= P||||||0.0070
71133901|NCT00571038|141770404|SUPERIORITY_OR_OTHER|||||||0.8395|TWO_SIDED||||||Kruskal-Wallis|||||||0.8395
71133902|NCT00571038|141770405|SUPERIORITY_OR_OTHER|||||||0.2194|TWO_SIDED||||||Kruskal-Wallis|||||||0.2194
71133903|NCT00571038|141770406|SUPERIORITY_OR_OTHER|||||||0.9191|TWO_SIDED||||||Kruskal-Wallis|||||||0.9191
71133904|NCT00571038|141770407|SUPERIORITY_OR_OTHER|||||||0.9633|TWO_SIDED||||||Kruskal-Wallis|||||||0.9633
71133905|NCT00571038|141770408|SUPERIORITY_OR_OTHER|||||||0.5901|TWO_SIDED||||||Kruskal-Wallis|||||||0.5901
71133906|NCT00571038|141770409|SUPERIORITY_OR_OTHER|||||||0.982|TWO_SIDED||||||Kruskal-Wallis|||||||0.9820
71133907|NCT00571038|141770410|SUPERIORITY_OR_OTHER|||||||0.3979|TWO_SIDED||||||Kruskal-Wallis|||||||0.3979
71133908|NCT00571038|141770411|SUPERIORITY_OR_OTHER|||||||0.1471|TWO_SIDED||||||Kruskal-Wallis|||||||0.1471
71133909|NCT00571038|141770412|SUPERIORITY_OR_OTHER|||||||0.6123|TWO_SIDED||||||Kruskal-Wallis|||||||0.6123
71133910|NCT00571038|141770413|SUPERIORITY_OR_OTHER|||||||0.5861|TWO_SIDED||||||Kruskal-Wallis|||||||0.5861
71133911|NCT00571038|141770414|SUPERIORITY_OR_OTHER|||||||0.4489|TWO_SIDED||||||Kruskal-Wallis|||||||0.4489
71133912|NCT00571038|141770415|SUPERIORITY_OR_OTHER|||||||0.2527|TWO_SIDED||||||Kruskal-Wallis|||||||0.2527
71133913|NCT00571038|141770416|SUPERIORITY_OR_OTHER|||||||0.7314|TWO_SIDED||||||Kruskal-Wallis|||||||0.7314
71133914|NCT00571038|141770417|SUPERIORITY_OR_OTHER|||||||0.9839|TWO_SIDED||||||Kruskal-Wallis|||||||0.9839
71133915|NCT02940496|141770471|SUPERIORITY||Correlation Coefficient (2 sided test)|0.081||||0.008|TWO_SIDED||||||t-test, 2 sided|||||||0.008
71133916|NCT02940496|141770472|SUPERIORITY||Correlation Coefficient (2-sided test)|0.88||||0.009|TWO_SIDED||||||t-test, 2 sided|||||||0.009
71133917|NCT02940496|141770473|SUPERIORITY||Correlation Coefficient (2-sided test)|0.79||||0.01|TWO_SIDED||||||t-test, 2 sided|||||||0.01
71133918|NCT01147055|141770477|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|18.21|||||TWO_SIDED|90.0|16.14|20.54||||||Natural log transformed AUC (0-∞) of crizotinib was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||20.54|16.14|
71133919|NCT01147055|141770478|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|31.49|||||TWO_SIDED|90.0|26.43|37.51||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||37.51|26.43|
71133920|NCT01147055|141770479|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|17.6|||||TWO_SIDED|90.0|15.48|20.02||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||20.02|15.48|
71133921|NCT01147055|141770484|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|5.49|||||TWO_SIDED|90.0|4.64|6.49||||||Natural log transformed AUClast of PF-06260182 was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||6.49|4.64|
70872136|NCT03808493|141229519|EQUIVALENCE|For log-transformed (natural log) Cmax, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|-0.0811|||||TWO_SIDED|90.0|-0.1658|0.0036||||||||0.0036|-0.1658|
71133922|NCT01147055|141770485|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|5.75|||||TWO_SIDED|90.0|4.86|6.81||||||Natural log transformed AUC (0 - ∞) of PF-06260182 was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||6.81|4.86|
71133923|NCT01147055|141770487|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|11.01|||||TWO_SIDED|90.0|9.02|13.45||||||Natural log transformed Cmax of PF-06260182 was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||13.45|9.02|
70872137|NCT03808493|141229520|EQUIVALENCE|For log-transformed (natural log) AUC∞, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|-0.0199|||||TWO_SIDED|90.0|-0.0731|0.0333||||||||0.0333|-0.0731|
70861449|NCT03607422|141209179|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|44.5|||<|0.001|TWO_SIDED|95.0|35.0|54.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||54.1|35.0|<0.001
70861450|NCT03607422|141209179|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|34.4|||<|0.001|TWO_SIDED|95.0|24.7|44.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||44.2|24.7|<0.001
70861451|NCT03607422|141209180|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|33.3|||<|0.001|TWO_SIDED|95.0|26.9|39.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||39.8|26.9|<0.001
71133924|NCT05919888|141770497|SUPERIORITY|||||||0.275|||||||Chi-squared|||||||0.275
71133925|NCT05919888|141770498|SUPERIORITY|||||||0.0056|||||||Chi-squared|||||||0.0056
71133926|NCT05919888|141770499|SUPERIORITY|||||||0.286|||||||Chi-squared|||||||0.286
71133927|NCT02204072|141770505|OTHER||Hazard Ratio (HR)|0.98||||0.9549|TWO_SIDED|95.0|0.57|1.7|||Two-sided log-rank test.||Cox proportional hazard model. Hazard ratio: Comparison vs Enzalutamide|||1.70|0.57|0.9549
70861452|NCT03607422|141209180|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|19.1|||<|0.001|TWO_SIDED|95.0|13.3|24.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||24.9|13.3|<0.001
70947838|NCT02366143|141396652|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.71||||0.0002|TWO_SIDED|95.0|0.59|0.85|||Log Rank|||ITT-WT population||0.85|0.59|0.0002
71133928|NCT02204072|141770508|OTHER||Hazard Ratio (HR)|1.19||||0.5425|TWO_SIDED|95.0|0.68|2.06|||Two-sided log-rank test.||Cox proportional hazards model. Hazard ratio: Comparison vs. Enzaludamide.|||2.06|0.68|0.5425
71133929|NCT02204072|141770509|OTHER||Hazard Ratio (HR)|1.16||||0.5534|TWO_SIDED|95.0|0.71|1.9|||Two-sided log-rank test.||Cox proportional hazards model. Hazard ratio: Comparison vs. Enzalutamide.|||1.90|0.71|0.5534
71133930|NCT02204072|141770510|OTHER||Hazard Ratio (HR)|0.64||||0.1514|TWO_SIDED|95.0|0.35|1.18|||Two-sided log-rank test.||Cox proportional hazards model. Hazard ratio: Comparison vs. Enzalutamide.|||1.18|0.35|0.1514
71133931|NCT02204072|141770514|OTHER||Odds Ratio (OR)|1.579||||0.6186|TWO_SIDED|95.0|0.269|12.515|||Regression, Logistic|Odds ratio, p-value and confidence interval were obtained from logistic regression model.||||12.515|0.269|0.6186
71133932|NCT02204072|141770516|OTHER||Odds Ratio (OR)|1.891||||0.192|TWO_SIDED|95.0|0.727|5.059|||Regression, Logistic||Odds ratio, p-value and confidence interval were obtained from logistic regression model.|||5.059|0.727|0.1920
71133933|NCT01895946|141770520|SUPERIORITY_OR_OTHER||Least square mean difference (LSM)|1.02|||||TWO_SIDED|90.0|0.86|1.2|||Mixed Models Analysis|||||1.20|0.86|
71133934|NCT01895946|141770520|SUPERIORITY_OR_OTHER||Least square means difference (LSM)|0.67|||||TWO_SIDED|90.0|0.55|0.82|||Mixed Models Analysis|||||0.82|0.55|
71133935|NCT01895946|141770521|SUPERIORITY_OR_OTHER||Least square means difference (LSM)|0.9|||||TWO_SIDED|90.0|0.77|1.06|||Mixed Models Analysis|||||1.06|0.77|
71133936|NCT01895946|141770521|SUPERIORITY_OR_OTHER||Least square means difference (LSM)|0.89|||||TWO_SIDED|90.0|0.76|1.05|||Mixed Models Analysis|||||1.05|0.76|
71133937|NCT00874848|141770529|SUPERIORITY_OR_OTHER|||||||0.2895|||||||Fisher Exact|||||||0.2895
71133938|NCT03089541|141770535|SUPERIORITY||Odds Ratio (OR)|0.17||||0.002|TWO_SIDED|95.0|0.06|0.52|||Regression, Logistic|||Comparison on Eating/Drinking using a model adjusted for timing of the assessment (weekend, time of day (am vs. pm), and day of study (1 to 7). The significance level was 0.05.||0.52|0.06|0.002
71133939|NCT03089541|141770535|SUPERIORITY||Odds Ratio (OR)|2.65||||0.07|TWO_SIDED|95.0|0.92|7.65|||Regression, Logistic|||Comparison on Traveling using a model adjusted for timing of the assessment (weekend, time of day (am vs. pm), and day of study (1 to 7)). The significance level was 0.05.||7.65|0.92|0.07
71133940|NCT03089541|141770535|SUPERIORITY||Odds Ratio (OR)|1.46||||0.4|TWO_SIDED|95.0|0.59|3.64|||Regression, Logistic|||Comparison on Working/Reading/Studying using a model adjusted for timing of the assessment (weekend, time of day (am vs. pm), and day of study (1 to 7). The significance level was 0.05.||3.64|0.59|0.40
71133941|NCT03089541|141770535|SUPERIORITY||Odds Ratio (OR)|1.34||||0.6|TWO_SIDED|95.0|0.51|3.53|||Regression, Logistic|||Comparison on Socializing using a model adjusted for timing of the assessment (weekend, time of day (am vs. pm), and day of study (1 to 7). The significance level was 0.05.||3.53|0.51|0.60
71133942|NCT03089541|141770535|SUPERIORITY||Odds Ratio (OR)|1.8||||0.06|TWO_SIDED|95.0|0.96|3.38|||Regression, Logistic|||Model on Public Space adjusted for timing of the assessment (weekend, time of day (am vs. pm), and day of study (1 to 7)). The significance level was 0.05.||3.38|0.96|0.06
71133943|NCT02324816|141770537|OTHER||success proportion|73.7|||||TWO_SIDED|95.0|48.8|90.9||||||||90.9|48.8|
71133944|NCT05169424|141770538|OTHER|Comparison of Stiolto (reference group) versus Trelegy for incidence rate of exacerbation.|Hazard Ratio (HR)|1.133||||0.064|TWO_SIDED|95.0|0.993|1.293|||Regression, Cox|Cox regression was for time to first exacerbation and cohort as covariate.||||1.293|0.993|0.064
71133945|NCT05169424|141770538|OTHER|||||||0.045|||||||Wilcoxon (Mann-Whitney)|||||||0.045
71133946|NCT05169424|141770538|OTHER|||||||0.063|||||||Log Rank|||||||0.063
71133947|NCT05169424|141770539|OTHER|Comparison of Stiolto (reference group) versus Trelegy.|Hazard Ratio (HR)|1.169||||0.057|TWO_SIDED|95.0|0.996|1.372|||Regression, Cox|Cox regression was for time to first exacerbation and cohort as covariate.||||1.372|0.996|0.057
70947839|NCT02366143|141396652|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.564||||0.0001|TWO_SIDED|95.0|0.418|0.76|||Log Rank|||Teff-high WT Population||0.760|0.418|0.0001
70947840|NCT02366143|141396653|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.492|||<|0.0001|TWO_SIDED|95.0|0.374|0.649|||Log Rank|||Teff-high Population||0.649|0.374|<.0001
70947841|NCT02366143|141396653|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.517|0.72|||Log Rank|||ITT Population||0.720|0.517|<.0001
70947842|NCT02366143|141396655|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.471|||<|0.0001|TWO_SIDED|95.0|0.352|0.647|||Log Rank|||TC2/3 or IC2/3 Subgroup||0.647|0.352|<.0001
70947843|NCT02366143|141396655|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.486|||<|0.0001|TWO_SIDED|95.0|0.386|0.639|||Log Rank|||TC1/2/3 or IC1/2/3 Subgroup||0.639|0.386|<.0001
71133948|NCT05169424|141770540|OTHER|Comparison of Stiolto (reference group) versus Trelegy.|Hazard Ratio (HR)|1.116||||0.114|TWO_SIDED|95.0|0.974|1.279|||Regression, Cox|Cox regression was for time to first exacerbation and cohort as covariate.||||1.279|0.974|0.114
71133949|NCT05169424|141770541|OTHER|Comparison of Stiolto (reference group) versus Trelegy.|Hazard Ratio (HR)|1.374||||0.273|TWO_SIDED|95.0|0.779|2.424|||Regression, Cox|Cox regression was for time to first exacerbation and cohort as covariate.||||2.424|0.779|0.273
70947844|NCT02366143|141396656|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.824||||0.2765|TWO_SIDED|95.0|0.58|1.169|||Log Rank|||TC2/3 or IC2/3, WT ITT||1.169|0.580|0.2765
71133950|NCT05169424|141770542|OTHER|Comparison of Stiolto (reference) versus Trelegy for incidence rate of pneumonia hospitalization.|Hazard Ratio (HR)|1.183||||0.429|TWO_SIDED|95.0|0.78|1.792|||Regression, Cox|||||1.792|0.780|0.429
71133951|NCT05169424|141770542|OTHER|||||||0.896|||||||Wilcoxon (Mann-Whitney)|||||||0.896
71133952|NCT05169424|141770542|OTHER|||||||0.932|||||||Log Rank|||||||0.932
71133953|NCT05169424|141770543|OTHER|Comparison of Stiolto (reference) versus Trelegy for incidence rate of pneumonia hospitalization.|Hazard Ratio (HR)|0.979||||0.935|TWO_SIDED|95.0|0.582|1.645|||Regression, Cox|||||1.645|0.582|0.935
70947845|NCT02366143|141396656|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.771||||0.0829|TWO_SIDED|95.0|0.575|1.035|||Log Rank|||TC1/2/3 or IC1/2/3, WT ITT||1.035|0.575|0.0829
71133954|NCT05169424|141770544|OTHER|Comparison of Stiolto (reference) versus Trelegy for incidence rate of pneumonia hospitalization.|Hazard Ratio (HR)|1.159||||0.507|TWO_SIDED|95.0|0.75|1.79|||Regression, Cox|||||1.790|0.750|0.507
71133955|NCT05169424|141770545|OTHER|Comparison of Stiolto (reference) versus Trelegy for incidence rate of pneumonia hospitalization.|Hazard Ratio (HR)|1.291||||0.726|TWO_SIDED|95.0|0.309|5.405|||Regression, Cox|||||5.405|0.309|0.726
71133956|NCT05169424|141770546|OTHER|||||||0.874|||||||t-test, 2 sided|||||||0.874
71133957|NCT05169424|141770546|OTHER||Exponential estimate|0.895||||0.01|TWO_SIDED|95.0|0.823|0.974|||ZINB regression with log link|The costs were modeled using Zero Inflated Negative Binomial (ZINB) regression with log link with cohort as the only covariate.|The analysis was for Stiolto versus Trlegy (Trelegy was the reference group).|||0.974|0.823|0.01
71133958|NCT05169424|141770547|OTHER|||||||0.899|||||||t-test, 2 sided|||||||0.899
71133959|NCT05169424|141770547|OTHER||Exponential estimate|0.897||||0.012|TWO_SIDED|95.0|0.824|0.976|||ZINB regression with log link|The costs were modeled using Zero Inflated Negative Binomial (ZINB) regression with log link with cohort as the only covariate.|The analysis was for Stiolto versus Trlegy (Trelegy was the reference group).|||0.976|0.824|0.012
71133960|NCT05169424|141770548|OTHER|||||||0.974|||||||t-test, 2 sided|||||||0.974
70861453|NCT03607422|141209181|SUPERIORITY||Adjusted Response Rate Difference|59.9|||<|0.001|TWO_SIDED|95.0|45.9|73.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||73.8|45.9|<0.001
70861454|NCT03607422|141209181|SUPERIORITY||Adjusted Response Rate Difference|55.8|||<|0.001|TWO_SIDED|95.0|41.1|70.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||70.4|41.1|<0.001
70861455|NCT03607422|141209182|SUPERIORITY||Adjusted Response Rate Difference|53.9|||<|0.001|TWO_SIDED|95.0|40.6|67.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||67.3|40.6|<0.001
70861456|NCT03607422|141209182|SUPERIORITY||Adjusted Response Rate Difference|39.4|||<|0.001|TWO_SIDED|95.0|25.7|53.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||53.1|25.7|<0.001
70861457|NCT03607422|141209183|SUPERIORITY||Adjusted Response Rate Difference|53.1|||<|0.001|TWO_SIDED|95.0|40.0|66.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||66.1|40.0|<0.001
70861458|NCT03607422|141209183|SUPERIORITY||Adjusted Response Rate Difference|35.0|||<|0.001|TWO_SIDED|95.0|21.8|48.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||48.2|21.8|<0.001
70861459|NCT03607422|141209184|SUPERIORITY||Adjusted Response Rate Difference|60.2|||<|0.001|TWO_SIDED|95.0|47.5|72.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||72.9|47.5|<0.001
70861460|NCT03607422|141209184|SUPERIORITY||Adjusted Response Rate Difference|46.7|||<|0.001|TWO_SIDED|95.0|33.4|59.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||59.9|33.4|<0.001
70861461|NCT03607422|141209185|SUPERIORITY||Adjusted Response Rate Difference|46.4|||<|0.001|TWO_SIDED|95.0|33.2|59.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||59.6|33.2|<0.001
70861462|NCT03607422|141209185|SUPERIORITY||Adjusted Response Rate Difference|34.9|||<|0.001|TWO_SIDED|95.0|21.4|48.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||48.4|21.4|<0.001
70861463|NCT03607422|141209186|SUPERIORITY||Adjusted Response Rate Difference|46.2|||<|0.001|TWO_SIDED|95.0|32.4|60.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||60.0|32.4|<0.001
70861464|NCT03607422|141209186|SUPERIORITY||Adjusted Response Rate Difference|31.3|||<|0.001|TWO_SIDED|95.0|17.3|45.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||45.3|17.3|<0.001
70861465|NCT03607422|141209187|SUPERIORITY||Adjusted Response Rate Difference|5.0||||0.075|TWO_SIDED|95.0|-0.5|10.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||10.6|-0.5|0.075
70861466|NCT03607422|141209187|SUPERIORITY||Adjusted Response Rate Difference|12.7||||0.005|TWO_SIDED|95.0|3.9|21.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||21.5|3.9|0.005
71133961|NCT05169424|141770548|OTHER||Exponential estimate|1.135||||0.595|TWO_SIDED|95.0|0.711|1.812|||ZINB regression with log link|The costs were modeled using Zero Inflated Negative Binomial (ZINB) regression with log link with cohort as the only covariate.|The analysis was for Stiolto versus Trlegy (Trelegy was the reference group).|||1.812|0.711|0.595
71133962|NCT05169424|141770549|OTHER|||||||0.622|||||||t-test, 2 sided|||||||0.622
70861467|NCT03607422|141209188|SUPERIORITY||Adjusted Response Rate Difference|3.2||||0.151|TWO_SIDED|95.0|-1.2|7.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||7.6|-1.2|0.151
70861468|NCT03607422|141209189|SUPERIORITY||Adjusted Response Rate Difference|12.9||||0.008|TWO_SIDED|95.0|3.4|22.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||22.3|3.4|0.008
70861469|NCT03607422|141209190|SUPERIORITY||Adjusted Response Rate Difference|-18.0|||<|0.001|TWO_SIDED|95.0|-28.0|-8.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||-8.0|-28.0|<0.001
70861470|NCT03607422|141209190|SUPERIORITY||Adjusted Response Rate Difference|-17.9||||0.001|TWO_SIDED|95.0|-28.1|-7.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||-7.7|-28.1|0.001
70861471|NCT03607422|141209191|SUPERIORITY||Adjusted Response Rate Difference|51.5|||<|0.001|TWO_SIDED|95.0|34.8|68.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||68.3|34.8|<0.001
70861472|NCT03607422|141209191|SUPERIORITY||Adjusted Response Rate Difference|29.2||||0.001|TWO_SIDED|95.0|11.8|46.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||46.6|11.8|0.001
70861473|NCT03607422|141209192|SUPERIORITY||Adjusted Response Rate Difference|53.2|||<|0.001|TWO_SIDED|95.0|38.4|68.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||68.0|38.4|<0.001
70861474|NCT03607422|141209192|SUPERIORITY||Adjusted Response Rate Difference|31.8|||<|0.001|TWO_SIDED|95.0|16.5|47.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||47.1|16.5|<0.001
70861475|NCT03607422|141209193|SUPERIORITY||Adjusted Response Rate Difference|48.9|||<|0.001|TWO_SIDED|95.0|33.8|64.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||64.1|33.8|<0.001
70861476|NCT03607422|141209193|SUPERIORITY||Adjusted Response Rate Difference|37.3|||<|0.001|TWO_SIDED|95.0|21.1|53.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||53.6|21.1|<0.001
71133963|NCT05169424|141770549|OTHER||Exponential estimate|1.008||||0.855|TWO_SIDED|95.0|0.928|1.094|||ZINB regression with log link|The costs were modeled using Zero Inflated Negative Binomial (ZINB) regression with log link with cohort as the only covariate.|The analysis was for Stiolto versus Trlegy (Trelegy was the reference group).|||1.094|0.928|0.855
71133964|NCT05169424|141770550|OTHER|||||||0.328|||||||t-test, 2 sided|||||||0.328
71133965|NCT00286429|141770565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|||<|0.001|TWO_SIDED|95.0|-0.72|-0.3||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 26. For comparison of either alogliptin dose vs. placebo (2-sample t test), study sample size \>=390 participants had 95% power to detect a treatment difference as small as 0.4% in the per protocol analysis set assuming a standard deviation of 0.8%, a 2-sided test at 0.05 significance level and \>=80% of subjects meeting the per protocol criteria.||-0.30|-0.72|<0.001
71133966|NCT00286429|141770565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||<|0.001|TWO_SIDED|95.0|-0.8|-0.37||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 26. For comparison of either alogliptin dose vs. placebo (2-sample t test), study sample size \>=390 participants had 95% power to detect a treatment difference as small as 0.4% in the per protocol analysis set assuming a standard deviation of 0.8%, a 2-sided test at 0.05 significance level and \>=80% of subjects meeting the per protocol criteria.||-0.37|-0.80|<0.001
71133967|NCT00286429|141770566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|||<|0.001|TWO_SIDED|95.0|-0.34|-0.09||No multiplicity adjustments|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.09|-0.34|<0.001
71133968|NCT00286429|141770566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|||<|0.001|TWO_SIDED|95.0|-0.45|-0.2||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.20|-0.45|<0.001
71133969|NCT00286429|141770567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|||<|0.001|TWO_SIDED|95.0|-0.65|-0.31||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.31|-0.65|<0.001
71133970|NCT00286429|141770567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|||<|0.001|TWO_SIDED|95.0|-0.73|-0.39||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.39|-0.73|<0.001
71133971|NCT00286429|141770568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.001|TWO_SIDED|95.0|-0.77|-0.37||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.37|-0.77|<0.001
70947846|NCT02366143|141396657|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.709||||0.0073|TWO_SIDED|95.0|0.551|0.913|||Log Rank|||TC1/2/3 or IC1/2/3 ITT-WT||0.913|0.551|0.0073
71133972|NCT00286429|141770568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.001|TWO_SIDED|95.0|-0.75|-0.34||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.34|-0.75|<0.001
71133973|NCT00286429|141770569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|||<|0.001|TWO_SIDED|95.0|-0.79|-0.37||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 16. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.37|-0.79|<0.001
71133974|NCT00286429|141770569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.001|TWO_SIDED|95.0|-0.75|-0.33||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 16. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.33|-0.75|<0.001
71133975|NCT00286429|141770570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||<|0.001|TWO_SIDED|95.0|-0.8|-0.37||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.37|-0.80|<0.001
71133976|NCT00286429|141770570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.001|TWO_SIDED|95.0|-0.79|-0.35||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.35|-0.79|<0.001
71133977|NCT00286429|141770571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.3||||0.128|TWO_SIDED|95.0|-25.9|3.3||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 1. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||3.3|-25.9|0.128
71133978|NCT00286429|141770571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.1||||0.034|TWO_SIDED|95.0|-31.1|-1.2||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 1. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-1.2|-31.1|0.034
70947847|NCT02366143|141396657|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.662||||0.0097|TWO_SIDED|95.0|0.484|0.907|||Log Rank|||TC2/3 or IC2/3 Population||0.907|0.484|0.0097
70861477|NCT03607422|141209194|SUPERIORITY||Adjusted Response Rate Difference|53.8|||<|0.001|TWO_SIDED|95.0|37.4|70.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||70.2|37.4|<0.001
70861478|NCT03607422|141209194|SUPERIORITY||Adjusted Response Rate Difference|42.0|||<|0.001|TWO_SIDED|95.0|24.3|59.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||59.7|24.3|<0.001
70861479|NCT03607422|141209195|SUPERIORITY||Adjusted Response Rate Difference|45.3|||<|0.001|TWO_SIDED|95.0|28.0|62.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||62.7|28.0|<0.001
70947848|NCT02366143|141396658|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.831||||0.2843|TWO_SIDED|95.0|0.592|1.167|||Log Rank|||Teff high-WT||1.167|0.592|0.2843
70947849|NCT02366143|141396658|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.802||||0.1861|TWO_SIDED|95.0|0.579|1.113|||Log Rank|||Teff high||1.113|0.579|0.1861
70947850|NCT02366143|141396658|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.764||||0.006|TWO_SIDED|95.0|0.63|0.926|||Log Rank|||ITT||0.926|0.630|0.0060
71133979|NCT00286429|141770572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1||||0.563|TWO_SIDED|95.0|-17.9|9.7||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 2. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||9.7|-17.9|0.563
71133980|NCT00286429|141770572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4||||0.084|TWO_SIDED|95.0|-26.4|1.7||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 2. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||1.7|-26.4|0.084
71133981|NCT00286429|141770573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.3||||0.16|TWO_SIDED|95.0|-24.7|4.1||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||4.1|-24.7|0.160
71133982|NCT00286429|141770573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.4||||0.02|TWO_SIDED|95.0|-32.1|-2.8||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-2.8|-32.1|0.020
71133983|NCT00286429|141770574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.9||||0.013|TWO_SIDED|95.0|-33.7|-4.0||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 8. The treatment effect was be evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-4.0|-33.7|0.013
70947851|NCT02366143|141396659|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.786||||0.0894|TWO_SIDED|95.0|0.595|1.038|||Log Rank|||Teff high-WT||1.038|0.595|0.0894
70861480|NCT03607422|141209195|SUPERIORITY||Adjusted Response Rate Difference|29.8||||0.002|TWO_SIDED|95.0|10.7|48.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||48.8|10.7|0.002
70947852|NCT02366143|141396659|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.815||||0.1276|TWO_SIDED|95.0|0.626|1.061|||Log Rank|||Teff high||1.061|0.626|0.1276
70947853|NCT02366143|141396659|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.861||||0.0681|TWO_SIDED|95.0|0.733|1.011|||Log Rank|||ITT||1.011|0.733|0.0681
70947854|NCT02366143|141396660|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.901||||0.4599|TWO_SIDED|95.0|0.683|1.188|||Log Rank|||Teff high-WT ITT||1.188|0.683|0.4599
70947855|NCT02366143|141396661|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.523|||<|0.0001|TWO_SIDED|95.0|0.406|0.675|||Log Rank|||ITT-WT||0.675|0.406|<.0001
71133984|NCT00286429|141770574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5||||0.011|TWO_SIDED|95.0|-34.5|-4.5||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-4.5|-34.5|0.011
71133985|NCT00286429|141770575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8||||0.624|TWO_SIDED|95.0|-18.9|11.3||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||11.3|-18.9|0.624
71133986|NCT00286429|141770575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.853|TWO_SIDED|95.0|-16.7|13.8||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||13.8|-16.7|0.853
71133987|NCT00286429|141770576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.9||||0.19|TWO_SIDED|95.0|-24.7|4.9||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 16. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||4.9|-24.7|0.190
71133988|NCT00286429|141770576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9||||0.154|TWO_SIDED|95.0|-25.8|4.1||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 16. The treatment effect was be evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||4.1|-25.8|0.154
71133989|NCT00286429|141770577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.7||||0.097|TWO_SIDED|95.0|-27.8|2.3||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||2.3|-27.8|0.097
71133990|NCT00286429|141770577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.9||||0.01|TWO_SIDED|95.0|-35.1|-4.7||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-4.7|-35.1|0.010
70947856|NCT02366143|141396661|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.283|0.624|||Log Rank|||Teff-high WT||0.624|0.283|<.0001
71133991|NCT00286429|141770578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.662|TWO_SIDED|95.0|-19.2|12.2||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||12.2|-19.2|0.662
70947857|NCT02366143|141396663|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|6.68||||0.0697|TWO_SIDED|95.0|-0.54|13.9|||Z-test|||1-Year ITT-WT Population||13.90|-0.54|0.0697
70947858|NCT02366143|141396663|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|9.71||||0.0347|TWO_SIDED|95.0|0.7|18.73|||Z-test|||2-Year ITT-WT Population||18.73|0.70|0.0347
70947859|NCT02366143|141396663|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|9.89||||0.089|TWO_SIDED|95.0|-1.51|21.29|||Z-test|||1-Year Teff-high WT Population||21.29|-1.51|0.0890
71133992|NCT00286429|141770578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.6||||0.03|TWO_SIDED|95.0|-33.4|-1.7||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-1.7|-33.4|0.030
71133993|NCT00286429|141770579|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.551||||0.075|TWO_SIDED|95.0|0.286|1.063||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in number of participants with marked hyperglycemia. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||1.063|0.286|0.075
70947860|NCT02366143|141396663|OTHER|Stratified Analysis|Difference in Event Free Rate|10.34||||0.1336|TWO_SIDED|95.0|-3.17|23.84|||Z-test|||2-Year Teff-high WT Population||23.84|-3.17|0.1336
70947861|NCT02366143|141396664|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|4.18||||0.2624|TWO_SIDED|95.0|-3.13|11.48|||Z-test|||1-Year ITT-WT Population||11.48|-3.13|0.2624
71133994|NCT00286429|141770579|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.364||||0.002|TWO_SIDED|95.0|0.191|0.695||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in number of participants with marked hyperglycemia. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||0.695|0.191|0.002
70861481|NCT03607422|141209196|SUPERIORITY||Adjusted Response Rate Difference|17.1|||<|0.001|TWO_SIDED|95.0|7.5|26.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||26.7|7.5|<0.001
70947862|NCT02366143|141396664|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|9.67||||0.0088|TWO_SIDED|95.0|2.43|16.9|||Z-test|||2-Year ITT-WT Population||16.90|2.43|0.0088
70947863|NCT02366143|141396664|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|10.56||||0.0649|TWO_SIDED|95.0|-0.65|21.77|||Z-test|||1-Year Teff-high WT Population||21.77|-0.65|0.0649
70947864|NCT02366143|141396664|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|7.27||||0.212|TWO_SIDED|95.0|-4.15|18.69|||Z-test|||2-Year Teff-high WT Population||18.69|-4.15|0.2120
70861482|NCT03607422|141209196|SUPERIORITY||Adjusted Response Rate Difference|13.7||||0.006|TWO_SIDED|95.0|3.9|23.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||23.5|3.9|0.006
70861483|NCT03607422|141209197|SUPERIORITY||LS Mean Difference|-55.93|STANDARD_ERROR_OF_MEAN|7.284|<|0.001|TWO_SIDED|95.0|-70.32|-41.55|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-41.55|-70.32|<0.001
70861484|NCT03607422|141209197|SUPERIORITY||LS Mean Difference|-36.54|STANDARD_ERROR_OF_MEAN|7.384|<|0.001|TWO_SIDED|95.0|-51.12|-21.96|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-21.96|-51.12|<0.001
70861485|NCT03607422|141209198|SUPERIORITY||LS Mean Difference|-42.62|STANDARD_ERROR_OF_MEAN|6.432|<|0.001|TWO_SIDED|95.0|-55.34|-29.9|||Mixed Effect Model Repeated Measurement|Mixed-Effect Model Repeat Measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-29.90|-55.34|<0.001
70861486|NCT03607422|141209198|SUPERIORITY||LS Mean Difference|-35.66|STANDARD_ERROR_OF_MEAN|6.447|<|0.001|TWO_SIDED|95.0|-48.41|-22.9|||Mixed Effect Model Repeated Measurement|Mixed-Effect Model Repeat Measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-22.90|-48.41|<0.001
70861487|NCT03607422|141209199|SUPERIORITY||Adjusted Response Rate Difference|52.5|||<|0.001|TWO_SIDED|95.0|36.9|68.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||68.1|36.9|<0.001
70861488|NCT03607422|141209199|SUPERIORITY||Adjusted Response Rate Difference|38.1|||<|0.001|TWO_SIDED|95.0|21.2|54.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||54.9|21.2|<0.001
70861489|NCT03607422|141209200|SUPERIORITY||Adjusted Response Rate Difference|55.9|||<|0.001|TWO_SIDED|95.0|35.5|76.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||76.3|35.5|<0.001
70861490|NCT03607422|141209200|SUPERIORITY||Adjusted Response Rate Difference|49.6|||<|0.001|TWO_SIDED|95.0|26.3|72.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||72.9|26.3|<0.001
70861491|NCT03607422|141209201|SUPERIORITY||LS Mean Difference|-44.9|STANDARD_ERROR_OF_MEAN|6.492|<|0.001|TWO_SIDED|95.0|-57.74|-32.06|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category|Difference = Upadacitinib - Placebo|||-32.06|-57.74|<0.001
70861492|NCT03607422|141209201|SUPERIORITY||LS Mean Difference|-29.98|STANDARD_ERROR_OF_MEAN|6.383|<|0.001|TWO_SIDED|95.0|-42.6|-17.36|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category|Difference = Upadacitinib - Placebo|||-17.36|-42.60|<0.001
70861493|NCT03607422|141209202|SUPERIORITY||Adjusted Response Rate Difference|27.8||||0.016|TWO_SIDED|95.0|5.2|50.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||50.4|5.2|0.016
70861494|NCT03607422|141209202|SUPERIORITY||Adjusted Response Rate Difference|22.3||||0.062|TWO_SIDED|95.0|-1.1|45.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||45.7|-1.1|0.062
70861495|NCT03607422|141209203|SUPERIORITY||Adjusted Response Rate Difference|38.9|||<|0.001|TWO_SIDED|95.0|18.4|59.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||59.4|18.4|<0.001
70861496|NCT03607422|141209203|SUPERIORITY||Adjusted Response Rate Difference|5.9||||0.51|TWO_SIDED|95.0|-11.7|23.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||23.6|-11.7|0.510
70861497|NCT03693170|141209204|OTHER|||||||||||||||||"The null hypothesis that the true response rate is 30% will be tested against a one-sided alternative.~The cORR will be provided with a corresponding Clopper-Pearson (exact) binomial 95% CI for the Efficacy Set.~This design yields a 1-sided type I error rate equal to 1.6% and power of 80% when the true response rate is 45%."|If 37 or more confirmed responses were observed in the 90 treated subjects with a centrally confirmed BRAFV600E mutation, corresponding to a lower limit of Clopper-Pearson (exact) binomial 95% CI exceeding 30%, the study was considered to have met its primary endpoint. If more than 90 subjects were enrolled, the lower limit of Clopper-Pearson was to be used for decision.|||
70861498|NCT02128828|141209235|SUPERIORITY|||||||0.0079|||||||Wilcoxon (Mann-Whitney)|||||||0.0079
70861499|NCT03228420|141209236|SUPERIORITY||||||<|0.001||||||2-sided alpha level of 0.05|Fisher Exact|||||||<0.001
70861500|NCT01298531|141209245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.27||||0.0019|TWO_SIDED|95.0|-44.17|-10.38|||ANCOVA|Not specifed.||The primary analysis of the primary endpoint was an Analysis of covariance (ANCOVA)with Baseline NSAID score and treatment as explanatory variables. The hypothesis tested for the primary endpoint was as follows: H0: ΔETN = ΔPlacebo; H1: ΔETN ≠ ΔPlacebo.||-10.38|-44.17|0.0019
70861501|NCT01298531|141209246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.78||||0.0115|TWO_SIDED|95.0|-34.99|-4.57|||ANCOVA|||The analysis of secondary endpoints was an ANCOVA using linear regression with Baseline NSAID score and MMRM was run using the model and using the repeated measures for the changes from Baseline in each outcome at Week 8.||-4.57|-34.99|0.0115
70872138|NCT03808493|141229520|EQUIVALENCE|For log-transformed (natural log) AUC∞, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.0035|||||TWO_SIDED|90.0|-0.076|0.083||||||||0.0830|-0.0760|
70861502|NCT01298531|141209247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93||||0.0153|TWO_SIDED|95.0|-1.68|-0.18|||ANCOVA|||The analysis of secondary endpoints was an ANCOVA using linear regression with Baseline NSAID score and MMRM was run using the model as detailed for the primary endpoint and using the repeated measures for the changes from Baseline in each outcome at Week 4.||-0.18|-1.68|0.0153
70861503|NCT01298531|141209248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88||||0.051|TWO_SIDED|95.0|-1.76|0.0|||ANCOVA|||The analysis of secondary endpoints was an ANCOVA using linear regression with Baseline NSAID score and MMRM was run using the model as detailed for the primary endpoint and using the repeated measures for the changes from Baseline in each outcome at Week 8.||0.00|-1.76|0.0510
70861504|NCT01298531|141209250|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.209||||0.0066|TWO_SIDED|95.0|0.07|0.65|||Regression, Logistic|||Logistic regression with baseline score and treatment group included as covariates.||0.65|0.07|0.0066
70861505|NCT01298531|141209251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-53.7||||0.0053|TWO_SIDED|95.0|-91.01|-16.38|||ANCOVA|||The changes from baseline in the continuous endpoints of mini BASDAI was analyzed using ANCOVA. The total NSAID score for the first 8 weeks of randomized treatment was calculated as an AUC using the linear trapezoidal rule.||-16.38|-91.01|0.0053
70861506|NCT01298531|141209252|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.963||||0.0324|TWO_SIDED|95.0|1.1|8.01|||Regression, Logistic|||Logistic regression with baseline morning stiffness score and treatment group included as covariates.||8.01|1.10|0.0324
70861507|NCT01298531|141209255|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.696||||0.0501|TWO_SIDED|95.0|1.0|7.27|||Regression, Logistic|||Week 8 was analyzed using a logistic regression to assess treatment effect. Logistic regression with baseline morning stiffness score and treatment group included as covariates.||7.27|1.00|0.0501
70861508|NCT01298531|141209257|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.103||||0.0284|TWO_SIDED|95.0|1.13|8.54|||Regression, Logistic|||Week 8 was analyzed using a logistic regression to assess treatment effect. Logistic regression with baseline morning stiffness score and treatment group included as covariates.||8.54|1.13|0.0284
70947865|NCT02366143|141396665|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.909||||0.6899|TWO_SIDED|95.0|0.571|1.45|||Log Rank|||Teff-high WT Population||1.450|0.571|0.6899
70947866|NCT02366143|141396665|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.671||||0.1043|TWO_SIDED|95.0|0.413|1.089|||Log Rank|||Teff-high WT Population||1.089|0.413|0.1043
71133995|NCT00286429|141770580|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.35|||<|0.001|TWO_SIDED|95.0|0.198|0.619||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) is alogliptin arm versus placebo arm. OR \<1.0 indicates lower incidence compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in number of participants requiring rescue. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||0.619|0.198|<0.001
71133996|NCT00286429|141770580|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.339|||<|0.001|TWO_SIDED|95.0|0.189|0.608||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in number of participants requiring rescue. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||0.608|0.189|<0.001
71133997|NCT00286429|141770581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156||||0.286|TWO_SIDED|95.0|-0.131|0.443||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-Peptide at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.443|-0.131|0.286
71133998|NCT00286429|141770581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.477||||0.001|TWO_SIDED|95.0|0.188|0.765||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.765|0.188|0.001
71133999|NCT00286429|141770582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.202||||0.236|TWO_SIDED|95.0|-0.132|0.536||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-Peptide at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.536|-0.132|0.236
71134000|NCT00286429|141770582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.372||||0.032|TWO_SIDED|95.0|0.032|0.712||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-Peptide at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.712|0.032|0.032
71134001|NCT00286429|141770583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126||||0.562|TWO_SIDED|95.0|-0.302|0.554||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.554|-0.302|0.562
71134002|NCT00286429|141770583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183||||0.407|TWO_SIDED|95.0|-0.251|0.616||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.616|-0.251|0.407
70947867|NCT02366143|141396665|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.232||||0.173||95.0|0.912|1.665|||Log Rank|||ITT WT||1.665|0.912|0.1730
70947868|NCT02366143|141396665|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.084||||0.6145|TWO_SIDED|95.0|0.792|1.483|||Log Rank|||ITT WT||1.483|0.792|0.6145
70947869|NCT02366143|141396666|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.041||||0.8816|TWO_SIDED|95.0|0.614|1.763|||Log Rank|||Cough for Teff-high WT ITT population||1.763|0.614|0.8816
70947870|NCT02366143|141396666|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.741||||0.2995|TWO_SIDED|95.0|0.419|1.309|||Log Rank|||Cough for Teff-high WT ITT Population||1.309|0.419|0.2995
70947871|NCT02366143|141396666|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.936||||0.7578|TWO_SIDED|95.0|0.616|1.422|||Log Rank|||Dyspnea in Teff-high WT Population||1.422|0.616|0.7578
71134003|NCT00286429|141770584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078||||0.716|TWO_SIDED|95.0|-0.344|0.5||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 16. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.500|-0.344|0.716
71134004|NCT00286429|141770584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156||||0.474|TWO_SIDED|95.0|-0.272|0.583||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 16. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.583|-0.272|0.474
71134005|NCT00286429|141770585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079||||0.7|TWO_SIDED|95.0|-0.324|0.482||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.482|-0.324|0.700
71134006|NCT00286429|141770585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042||||0.839|TWO_SIDED|95.0|-0.366|0.45||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.450|-0.366|0.839
71134007|NCT00286429|141770586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.282||||0.091|TWO_SIDED|95.0|-0.045|0.61||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.610|-0.045|0.091
71134008|NCT00286429|141770586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125||||0.459|TWO_SIDED|95.0|-0.207|0.457||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.457|-0.207|0.459
71134009|NCT00286429|141770588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.65||||0.016|TWO_SIDED|95.0|1.589|100.682||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c ≤7.0%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||100.682|1.589|0.016
71134010|NCT00286429|141770588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.255||||0.023|TWO_SIDED|95.0|1.401|90.379||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c ≤7.0%. The treatment effect was evaluated as a contrast of each active dose versus placebo was evaluated inferentially with a Wald test at the 0.05 significance level||90.379|1.401|0.023
70861509|NCT01298531|141209259|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13||||0.3291|TWO_SIDED|95.0|0.47|9.72|||Regression, Logistic|||Week 8 was analyzed using a logistic regression to assess treatment effect. Logistic regression with baseline morning stiffness score and treatment group included as covariates.||9.72|0.47|0.3291
71134011|NCT00286429|141770589|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.777|||<|0.001|TWO_SIDED|95.0|2.047|16.305||No multiplicity adjustments.|ANCOVA|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c ≤7.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||16.305|2.047|<0.001
71134012|NCT00286429|141770589|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.784|||<|0.001|TWO_SIDED|95.0|3.54|27.039||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c ≤7.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||27.039|3.540|<0.001
71134013|NCT00286429|141770590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.674|||<|0.001|TWO_SIDED|95.0|1.579|4.53||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥0.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||4.530|1.579|<0.001
71134014|NCT00286429|141770590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.819|||<|0.001|TWO_SIDED|95.0|1.653|4.808||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥0.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||4.808|1.653|<0.001
71134015|NCT00286429|141770591|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.163|||<|0.001|TWO_SIDED|95.0|1.651|6.06||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥1.0%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||6.060|1.651|<0.001
70947872|NCT02366143|141396666|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.041||||0.847|TWO_SIDED|95.0|0.694|1.56|||Log Rank|||Dyspnea in Teff-high WT Population||1.560|0.694|0.8470
70861510|NCT01298531|141209260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.0001|TWO_SIDED|95.0|-1.11|-0.44|||ANCOVA|||ANCOVA model on change from baseline ASDAS CRP score fitting baseline ASDAS CRP score as a covariate, plus treatment as a factor.||-0.44|-1.11|<0.0001
71134016|NCT00286429|141770591|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.989|||<|0.001|TWO_SIDED|95.0|2.083|7.64||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥1.0%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||7.640|2.083|<0.001
70947873|NCT02366143|141396666|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.659||||0.1289|TWO_SIDED|95.0|0.383|1.133|||Log Rank|||Pain in Chest in Teff-high WT Population||1.133|0.383|0.1289
70947874|NCT02366143|141396666|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.729||||0.2381|TWO_SIDED|95.0|0.43|1.235|||Log Rank|||Pain in Chest in Teff-high WT Population||1.235|0.430|0.2381
71134017|NCT00286429|141770592|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.55||||0.002|TWO_SIDED|95.0|1.732|11.953||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥1.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||11.953|1.732|0.002
71134018|NCT00286429|141770592|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.58||||0.002|TWO_SIDED|95.0|1.74|12.052||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥1.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||12.052|1.740|0.002
71134019|NCT00286429|141770594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.291|TWO_SIDED|95.0|-0.81|0.24||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.24|-0.81|0.291
71134020|NCT00286429|141770594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.439|TWO_SIDED|95.0|-0.74|0.32||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.32|-0.74|0.439
71134021|NCT00286429|141770595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.841|TWO_SIDED|95.0|-0.67|0.55||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.55|-0.67|0.841
71134022|NCT00286429|141770595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.556|TWO_SIDED|95.0|-0.8|0.43||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.43|-0.80|0.556
71134023|NCT00286429|141770596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.586|TWO_SIDED|95.0|-0.81|0.46||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.46|-0.81|0.586
71134024|NCT00286429|141770596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.404|TWO_SIDED|95.0|-0.91|0.37||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.37|-0.91|0.404
71134025|NCT00286429|141770597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.874|TWO_SIDED|95.0|-0.62|0.72||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.72|-0.62|0.874
71134026|NCT00286429|141770597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.948|TWO_SIDED|95.0|-0.7|0.65||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.65|-0.70|0.948
71134027|NCT00595478|141770599|SUPERIORITY||Odds Ratio (OR)|0.8||||0.66|TWO_SIDED|95.0|0.29|2.18|||Poisson regression|Chi-square test with 1 degree of freedom|Odds ratio for 0 ETG-positive samples for MET/CBT+CM/BPT (numerator) vs. MET/CTB (denominator)|||2.18|0.29|0.66
71134028|NCT00595478|141770599|SUPERIORITY||mean ratio|0.93||||0.61|TWO_SIDED|95.0|0.71|1.22|||Poisson regression|Chi-square test with 1 degree of freedom|Mean ratio for number of ETG-positive samples, if \>0 ETG-positive samples: MET/CBT+CM/BPT (numerator) vs. MET/CTB (denominator)|||1.22|0.71|0.61
71134029|NCT00595478|141770600|SUPERIORITY||Odds Ratio (OR)|0.82||||0.74|TWO_SIDED|95.0|0.26|2.62|||Poisson regression|Chi-square test with 1 degree of freedom|Odds ratio for 0% days using alcohol during the 36 week follow-up period: MET/CBT+CM/BPT (numerator) vs. MET/CTB (denominator)|||2.62|0.26|0.74
71134030|NCT00595478|141770600|SUPERIORITY||mean ratio|0.74||||0.007|TWO_SIDED|95.0|0.59|0.92|||Poisson regression|Chi-square test with 1 degree of freedom|Mean ratio for percentage of days with alcohol use during the 36 week follow-up period, if alcohol was used: MET/CBT+CM/BPT (numerator) vs. MET/CTB (denominator)|||.92|.59|0.007
70861511|NCT01298531|141209261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.0011|TWO_SIDED|95.0|-1.09|-0.28|||ANCOVA|||ANCOVA model on change from baseline ASDAS CRP score fitting baseline ASDAS CRP score as a covariate, plus treatment as a factor.||-0.28|-1.09|0.0011
70861512|NCT01298531|141209263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0011|TWO_SIDED|95.0|-0.9|-0.24|||ANCOVA|||ANCOVA model on change from baseline ASDAS ESR score fitting baseline ASDAS ESR score as a covariate, plus treatment as a factor.||-0.24|-0.90|0.0011
71134031|NCT03691571|141770614|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||Esophageal thermal injury was detected in 13/44 (30%) patients.||||>.05
71134032|NCT03691571|141770616|OTHER|feasibility/pilot study||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
71134033|NCT03691571|141770617|OTHER|feasibility/pilot study||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
71134034|NCT03691571|141770618|OTHER|feasibility/pilot study||||||0.1|||||||Fisher Exact|||||||0.10
71134035|NCT00186901|141770621|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.02||||0.86||95.0|||||Wilcoxon Test|||Baseline where N=134||||0.86
71134036|NCT00186901|141770621|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.17||||0.99||95.0|||||Wilcoxon Test|||12 Month BMD Z-Score Calculation where N=109||||0.99
71134037|NCT00186901|141770621|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.04||||0.54||95.0|||||Wilcoxon Test|||24 Month BMD Z-Score calculation where N=91||||0.54
71134038|NCT00186901|141770621|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.04||||0.31||95.0|||||Wilcoxon Test|||36 Month (End of Study) BMD Z-Score calculation where N=84||||0.31
71134039|NCT00186901|141770622|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.32||||0.0004||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0004
71134040|NCT00186901|141770623|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.69||||0.0023||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0023
71134041|NCT00186901|141770624|SUPERIORITY_OR_OTHER|||||||0.0092||95.0|||||Kruskal-Wallis|||||||0.0092
70861513|NCT01298531|141209264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67||||0.0037|TWO_SIDED|95.0|-1.11|-0.22|||ANCOVA|||ANCOVA model on change from baseline ASDAS ESR score fitting baseline ASDAS ESR score as a covariate, plus treatment as a factor.||-0.22|-1.11|0.0037
70861514|NCT01298531|141209268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.005|TWO_SIDED|95.0|-2.2|-0.4|||ANCOVA|||ANCOVA model on change from baseline BAS-G score fitting baseline BAS-G score as a covariate, plus treatment as a factor.||-0.40|-2.20|0.0050
70861515|NCT01298531|141209269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24||||0.0256|TWO_SIDED|95.0|-2.33|-0.16|||ANCOVA|||ANCOVA model on change from baseline BAS-G score fitting baseline BAS-G score as a covariate, plus treatment as a factor.||-0.16|-2.33|0.0256
70861516|NCT01298531|141209271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.0474|TWO_SIDED|95.0|-2.0|-0.01|||ANCOVA|||ANCOVA model on change from baseline total back pain fitting baseline total back pain as a covariate, plus treatment as a factor.||-0.01|-2.00|0.0474
70861517|NCT01298531|141209272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.0212|TWO_SIDED|95.0|-2.36|-0.2|||ANCOVA|||ANCOVA model on change from baseline total back pain fitting baseline total back pain as a covariate, plus treatment as a factor||-0.20|-2.36|0.0212
70861518|NCT01298531|141209274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31||||0.0198|TWO_SIDED|95.0|-2.4|-0.21|||ANCOVA|||ANCOVA model on change from baseline nocturnal back pain fitting baseline nocturnal back pain as a covariate, plus treatment as a factor||-0.21|-2.40|0.0198
70861519|NCT01298531|141209275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51||||0.0132|TWO_SIDED|95.0|-2.69|-0.32|||ANCOVA|||ANCOVA model on change from baseline nocturnal back pain fitting baseline nocturnal back pain as a covariate, plus treatment as a factor||-0.32|-2.69|0.0132
70861520|NCT01298531|141209277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81||||0.0237|TWO_SIDED|95.0|-1.5|-0.11|||ANCOVA|||ANCOVA model on change from baseline BASFI score fitting baseline BASFI score as a covariate, plus treatment as a factor.||-0.11|-1.50|0.0237
70861521|NCT01298531|141209278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91||||0.0297|TWO_SIDED|95.0|-1.74|-0.09|||ANCOVA|||ANCOVA model on change from baseline BASFI score fitting baseline BASFI score as a covariate, plus treatment as a factor.||-0.09|-1.74|0.0297
70861522|NCT01298531|141209279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16||||0.0152|TWO_SIDED|95.0|-2.09|-0.23|||ANCOVA|||ANCOVA model on change from each baseline BASDAI component score fitting each baseline component score as a covariate, plus treatment as a factor.||-0.23|-2.09|0.0152
70947875|NCT02366143|141396666|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.09||||0.7163|TWO_SIDED|95.0|0.685|1.732|||Log Rank|||Arm and/or Shoulder Pain in Teff-high WT||1.732|0.685|0.7163
70861523|NCT01298531|141209280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15||||0.0344|TWO_SIDED|95.0|-2.22|-0.09|||ANCOVA|||ANCOVA model on change from each baseline BASDAI component score fitting each baseline component score as a covariate, plus treatment as a factor.||-0.09|-2.22|0.0344
70861524|NCT01298531|141209282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.0017|TWO_SIDED|95.0|-2.16|-0.52|||ANCOVA|||ANCOVA model on change from baseline PGA score fitting baseline PGA score as a covariate, plus treatment as a factor||-0.52|-2.16|0.0017
70947876|NCT02366143|141396666|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.693||||0.1502|TWO_SIDED|95.0|0.42|1.145|||Log Rank|||Arm and/or Shoulder Pain in Teff-high WT||1.145|0.420|0.1502
70861525|NCT01298531|141209283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12||||0.0233|TWO_SIDED|95.0|-2.07|-0.16|||ANCOVA|||ANCOVA model on change from baseline PGA score fitting baseline PGA score as a covariate, plus treatment as a factor.||-0.16|-2.07|0.0233
70861526|NCT01298531|141209292|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01||||0.126|TWO_SIDED|95.0|0.822|4.901|||Regression, Logistic|||Week 8 was analyzed using logistic regression with baseline score and treatment group included as covariates.||4.901|0.822|0.1260
70861527|NCT01298531|141209295|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.47||||0.0498|TWO_SIDED|95.0|1.0|6.08|||Regression, Logistic|||Logistic regression with baseline morning stiffness score and treatment group included as covariates. Week 8 was analyzed using a logistic regression to assess treatment effect.||6.08|1.00|0.0498
70861528|NCT01298531|141209297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.1601|TWO_SIDED|95.0|-0.87|0.15|||ANCOVA|||ANCOVA model on change from baseline BASMI score fitting baseline BASMI score as a covariate, plus treatment as a factor||0.15|-0.87|0.1601
70861529|NCT01298531|141209298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.2967|TWO_SIDED|95.0|-0.86|0.27|||ANCOVA|||ANCOVA model on change from baseline BASMI score fitting baseline BASMI score as a covariate, plus treatment as a factor||0.27|-0.86|0.2967
70861530|NCT01298531|141209304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.41||||0.2735|TWO_SIDED|95.0|-1.94|6.75|||ANCOVA|||ANCOVA model on change from baseline in chest expansion mobility score fitting baseline chest expansion mobility score as a covariate, plus treatment as a factor.||6.75|-1.94|0.2735
70861531|NCT01298531|141209305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68||||0.0422|TWO_SIDED|95.0|0.02|1.34|||ANCOVA|||ANCOVA model on change from baseline in chest expansion mobility score fitting baseline chest expansion mobility score as a covariate, plus treatment as a factor.||1.34|0.02|0.0422
70861532|NCT01841736|141209307|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0005|TWO_SIDED|80.0|0.42|0.69|||Log Rank|Stratified log rank||||0.69|0.42|0.0005
70861533|NCT01841736|141209309|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.7|TWO_SIDED|80.0|0.84|1.51|||Log Rank|Stratified Log-Rank||||1.51|0.84|0.7
70861534|NCT00559754|141209366|SUPERIORITY_OR_OTHER|||||||0.4915|||||||Fisher Exact|||||||0.4915
70861535|NCT00559754|141209367|SUPERIORITY_OR_OTHER|||||||0.4864|||||||Chi-squared|||||||0.4864
70861536|NCT00559754|141209368|SUPERIORITY_OR_OTHER|||||||0.3613|||||||Fisher Exact|||||||0.3613
70861537|NCT00559754|141209369|SUPERIORITY_OR_OTHER|||||||0.6605|||||||Fisher Exact|||||||0.6605
70861538|NCT00559754|141209370|SUPERIORITY_OR_OTHER|||||||0.8311|||||||Fisher Exact|||||||0.8311
70861539|NCT00559754|141209371|SUPERIORITY_OR_OTHER|||||||0.223|||||||Fisher Exact|||||||0.2230
70947877|NCT02366143|141396666|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.01||||0.9568|TWO_SIDED|95.0|0.713|1.43|||Log Rank|||Cough in ITT-WT Population||1.430|0.713|0.9568
70947878|NCT02366143|141396666|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.891||||0.5377|TWO_SIDED|95.0|0.619|1.284|||Log Rank|||Cough in ITT-WT Population||1.284|0.619|0.5377
70947879|NCT02366143|141396666|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.893||||0.4012|TWO_SIDED|95.0|0.685|1.163|||Log Rank|||Dyspnea in ITT-WT Population||1.163|0.685|0.4012
70861540|NCT00559754|141209372|SUPERIORITY_OR_OTHER|||||||0.8696|||||||Fisher Exact|||||||0.8696
70861541|NCT00559754|141209373|SUPERIORITY_OR_OTHER|||||||0.0074|||||||Fisher Exact|||||||0.0074
70861542|NCT00559754|141209374|SUPERIORITY_OR_OTHER|||||||0.3235|||||||Fisher Exact|||||||0.3235
70861543|NCT00559754|141209375|SUPERIORITY_OR_OTHER|||||||0.0693|||||||Fisher Exact|||||||0.0693
70861544|NCT00559754|141209377|SUPERIORITY_OR_OTHER|||||||0.4254|||||||Fisher Exact|||||||0.4254
70861545|NCT00559754|141209379|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
70861546|NCT00559754|141209380|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
70861547|NCT00559754|141209382|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
70861548|NCT01068652|141209427|NON_INFERIORITY_OR_EQUIVALENCE|The treatment comparison was based on a non-inferiority criterion and the following hypotheses were tested: H0: μDetemir - μBIAsp 30 ≥0.4% against the alternative hypothesis (Detemir non-inferior to BIAsp 30) HA: μDetemir - μBIAsp 30 \<0.4% where μBIAsp 30 and μDetemir are the mean HbA1c after 50 weeks of treatment with the two treatment regimens.|Mean Difference (Final Values)|0.11||||0.3406||95.0|-0.12|0.34|||ANCOVA|||To investigate the effect of different treatments, an analysis of covariance (ANCOVA) model was used to analyse HbA1c at week 50 with treatment group (2 categories: insulin detemir and aspart; BIAsp 30), country and pre-trial OAD(s) treatment (one OAD vs. more OADs) as factors and HbA1c at baseline (week 0) as a covariate. The treatment difference was estimated and a 95% confidence interval (CI) for the difference was calculated.||0.34|-0.12|0.3406
70947880|NCT02366143|141396666|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.05||||0.7149|TWO_SIDED|95.0|0.809|1.363|||Log Rank|||Dyspnea in ITT-WT Population||1.363|0.809|0.7149
70861549|NCT00573248|141209536|SUPERIORITY_OR_OTHER||||||<|0.025|ONE_SIDED|||||Adjusted for multiple comparisons|ANOVA|||2 (nicotine versus placebo) x 2 (smokers versus nonsmokers) ANOVA for each diary item||||<0.025
70861550|NCT00573248|141209537|SUPERIORITY_OR_OTHER||||||<|0.025|ONE_SIDED||||||ANOVA|||2 (nicotine versus placebo) x 2 (smoker versus nonsmoker) ANOVA||||<0.025
70861551|NCT00573248|141209538|SUPERIORITY_OR_OTHER||||||<|0.025|ONE_SIDED|||||Adjusted for multiple comparisons|ANOVA|||2 (nicotine versus placebo) x 2 (smokers versus nonsmokers) ANOVA for each diary item||||<0.025
71134042|NCT00186901|141770625|SUPERIORITY_OR_OTHER||Correlation coefficient|0.41|||<|0.0001|TWO_SIDED|95.0|0.25|0.55|||Z-test|||275 received a QCT and 121 received a DXA scan. 121 paired scans were evaluated.||0.55|0.25|<0.0001
70861552|NCT00573248|141209539|SUPERIORITY_OR_OTHER||||||<|0.025|ONE_SIDED|||||Adjusted for multiple comparisons|ANOVA|||2 (nicotine versus placebo) x 2 (smokers versus nonsmokers) ANOVA for each diary item||||<0.025
70861553|NCT01013649|141209552|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.62|TWO_SIDED|95.0|0.79|1.38||One-sided significance level = 0.15|Log Rank||Reference level = Arm I|A total of 200 deaths between the arms will provide 80% power to detect a signal for an increase in median overall survival from 22 to 28.8 months and 90% power to detect a signal for an increase in median overall survival from 22 to 30.6 months (HRs of 0.76 and 0.72, respectively, in favor of the erlotinib arm) with the addition of erlotinib and a 1-sided alpha of 0.15||1.38|0.79|0.62
70861554|NCT01013649|141209553|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.38|TWO_SIDED|90.0|0.79|1.18||One-sided significance level = 0.05.|Log Rank||Reference level = Arm III|316 deaths from step 2 randomized patients provides 80% power, with 0.05 1-sided alpha, to detect an OS increase (HR=0.76 in favor of arm IV), corresponding to increasing median OS from 17 to 22.5 months with the addition of RT. For analysis triggered by patients having 5 years potential follow-up from step 2 randomization, it is projected that at least 265 events will be observed, providing at least 72% power. The trigger used for the primary analysis was 5-years of follow-up (270 deaths).||1.18|0.79|0.38
70861555|NCT01013649|141209554|SUPERIORITY||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.8|1.31|||||Reference level = Arm I|||1.31|0.80|
70861556|NCT01013649|141209555|SUPERIORITY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|90.0|0.68|0.99|||||Reference level = Arm III|||0.99|0.68|
70861557|NCT05323656|141209590|SUPERIORITY||LS Mean Difference|5.05|STANDARD_ERROR_OF_MEAN|13.077||0.7008|TWO_SIDED|80.0|-11.98|22.0|||ANCOVA||The LS Mean difference is for the Setanaxib Group minus the Placebo Group|Null hypothesis: the mean best percentage change in the tumour size between the treatment groups are the same. With 25 patients per treatment group, using a 2-sided t-test, there will be 85% power to detect a 20% mean difference between the treatment groups in best percentage change in tumour size, with an estimated standard deviation of 30% and a 2 sided alpha of 20%.||22.0|-11.98|0.7008
70861558|NCT05323656|141209591|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.1023|TWO_SIDED|80.0|0.38|0.89|||Regression, Cox|||Null hypothesis: The risk for progression, as defined by RECIST v1.1, is the same between treatment groups. If the true hazard ratio is 0.5, approximately 38 progression events as defined by RECIST v1.1 will be required to have \> 80% power to demonstrate a statistically significant difference in PFS with 2-sided p\<0.2||0.89|0.38|.1023
70861559|NCT05323656|141209592|SUPERIORITY||LS Mean Difference|9.5|STANDARD_ERROR_OF_MEAN|8.89||0.2986|TWO_SIDED|80.0|-2.3|21.3||a priori threshold for significance (0.2) not met.|ANCOVA||The LS Mean difference is for the Setanaxib Group minus the Placebo Group.|Null Hypothesis: Mean difference in postbaseline CAF levels does not differ between treatment groups. ANCOVA model is on postbaseline CAFs level with a fixed factor for treatment and a covariate for baseline.||21.3|-2.3|0.2986
70861560|NCT05323656|141209593|SUPERIORITY||LS Mean Difference|6.83|STANDARD_ERROR_OF_MEAN|12.48||0.5918|TWO_SIDED|80.0|-9.86|23.52|||ANCOVA||The LS Mean difference is for the Setanaxib Group minus the Placebo Group.|Null Hypothesis: Mean difference in postbaseline CD8+ TILs does not differ between treatment groups. ANCOVA model is on postbaseline CD8+ TILs level with a fixed factor for treatment and a covariate for baseline.||23.52|-9.86|0.5918
70872139|NCT03808493|141229521|EQUIVALENCE|For log-transformed (natural log) Tmax, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.1902|||||TWO_SIDED|90.0|0.0199|0.3605||||||||0.3605|0.0199|
70947881|NCT02366143|141396666|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.057||||0.7126|TWO_SIDED|95.0|0.786|1.422|||Log Rank|||Arm and/or Shoulder Pain in ITT-WT||1.422|0.786|0.7126
71134043|NCT00186901|141770626|SUPERIORITY_OR_OTHER||Correlation coefficient|0.54|||<|0.0001|TWO_SIDED|95.0|0.38|0.67|||Z-test|||218 patients were assessed at 12 months and received a QCT Scan. 94 patients were also assessed using the DEXA Scan. Comparison of the two methods used 94 paired studies to arrive at a correlation coefficient.||0.67|0.38|<0.0001
71134044|NCT00186901|141770627|SUPERIORITY_OR_OTHER||Correlation coefficient|0.53|||<|0.0001|TWO_SIDED|95.0|0.36|0.66|||Z-test|||188 patients were assessed at baseline and received a QCT Scan. 90 patients were also assessed using the DEXA Scan. Comparison of the two methods used 90 paired studies to arrive at a correlation coefficient.||0.66|0.36|<0.0001
71134045|NCT00186901|141770628|SUPERIORITY_OR_OTHER||Correlation coefficient|0.48|||<|0.0001|TWO_SIDED|95.0|0.3|0.63|||Z-test|||180 patients were assessed at 36 months and received a QCT Scan. 89 patients were also assessed using the DXA Scan. Comparison of the two methods used 89 paired studies to arrive at a correlation coefficient.||0.63|0.30|<0.0001
71134046|NCT00186901|141770629|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Kruskal Wallis|||||||0.40
71134047|NCT00186901|141770630|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Kruskal Wallis|||||||0.21
71134048|NCT02363959|141770664|OTHER||Odds Ratio (OR)|1.0||||1|TWO_SIDED||||||Fisher Exact|||||||1
71134049|NCT02363959|141770665|OTHER|||||||0.39|||||||Fisher Exact|||||||0.39
71134050|NCT02363959|141770666|OTHER|||||||1|||||||Fisher Exact|||||||1
71134051|NCT02363959|141770667|OTHER|||||||1|||||||Fisher Exact|||||||1
71134052|NCT02363959|141770668|OTHER|||||||1|||||||Fisher Exact|||||||1
71134053|NCT02363959|141770669|OTHER|||||||1|||||||Fisher Exact|||||||1
71134054|NCT02267538|141770686|OTHER||Odds Ratio (OR)|0.62||||0.341|TWO_SIDED|95.0|0.23|1.65|||Regression, Logistic|||||1.65|0.23|0.341
71134055|NCT02267538|141770687|OTHER||Median Difference (Final Values)|0.0||||0.83|TWO_SIDED|||||MMSE|Wilcoxon (Mann-Whitney)|||||||0.830
71134056|NCT02267538|141770687|OTHER||Median Difference (Final Values)|0.0||||0.405|TWO_SIDED|||||m-TICS|Wilcoxon (Mann-Whitney)|||||||0.405
71134057|NCT02267538|141770688|OTHER||Odds Ratio (OR)|0.74||||0.214|TWO_SIDED|95.0|0.47|1.19|||Regression, Logistic|||Incidence of total non-delirium complications within 30 days after surgery||1.19|0.47|0.214
71134058|NCT02267538|141770688|OTHER|stroke|Odds Ratio (OR)|1.01||||0.993|TWO_SIDED|95.0|0.2|5.08|||Regression, Logistic|||Incidence of stroke within 30 days after surgery||5.08|0.20|0.993
71134059|NCT02267538|141770688|OTHER|New onset arrythmia|Odds Ratio (OR)|0.76||||0.274|TWO_SIDED|95.0|0.46|1.25|||Regression, Logistic|||||1.25|0.46|0.274
71134060|NCT02267538|141770688|OTHER|Pulmonary complications|Odds Ratio (OR)|0.51||||0.05|TWO_SIDED|95.0|0.26|1.0|||Regression, Logistic|||||1.00|0.26|0.050
71134061|NCT02267538|141770688|OTHER||Odds Ratio (OR)|0.5||||0.423|TWO_SIDED|95.0|0.09|2.75||Upper gastrointestinal bleeding|Regression, Logistic|||||2.75|0.09|0.423
71134062|NCT02267538|141770688|OTHER||Odds Ratio (OR)|1.01||||0.993|TWO_SIDED|95.0|0.2|5.08||Surgical bleeding|Regression, Logistic|||||5.08|0.20|0.993
71134063|NCT02267538|141770688|OTHER||Odds Ratio (OR)|1.63||||0.326|TWO_SIDED|95.0|0.61|4.34||Wound dehiscence or infection|Regression, Logistic|||||4.34|0.61|0.326
71134064|NCT02267538|141770688|OTHER||Odds Ratio (OR)|0.79||||0.378|TWO_SIDED|95.0|0.47|1.33||Acute kidney injur|Regression, Logistic|||||1.33|0.47|0.378
71134065|NCT02267538|141770688|OTHER||Odds Ratio (OR)|0.48||||0.156|TWO_SIDED|95.0|0.18|1.32||IABP assistance|Regression, Logistic|||||1.32|0.18|0.156
71134066|NCT02267538|141770689|OTHER||Median Difference (Final Values)|0.0||||0.596|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the first row in Outcome 4, i.e., Pain score in Day 1 after surgery, at rest between DEX Group and CTRL group||0|-1|0.596
71134067|NCT02267538|141770689|OTHER||Median Difference (Final Values)|0.0||||0.743|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the second row in Outcome 4, i.e., Pain score in Day 2 after surgery, at rest between DEX Group and CTRL group||0|-1|0.743
71134068|NCT02267538|141770689|OTHER||Median Difference (Final Values)|0.0||||0.282|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the third row in Outcome 4, i.e., Pain score in Day 3 after surgery, at rest between DEX Group and CTRL group||0|-1|0.282
71134069|NCT02267538|141770689|OTHER||Median Difference (Final Values)|0.0||||0.368|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the fourth row in Outcome 4, i.e., Pain score in Day 4 after surgery, at rest between DEX Group and CTRL group||0|0|0.368
71134070|NCT02267538|141770689|OTHER||Median Difference (Final Values)|0.0||||0.397|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the fifth row in Outcome 4, i.e., Pain score in Day 5 after surgery, at rest between DEX Group and CTRL group||0|0|0.397
71134071|NCT02267538|141770689|OTHER||Median Difference (Final Values)|0.0||||0.486|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the sixth row in Outcome 4, i.e., Pain score in Day 1 after surgery, with coughing between DEX Group and CTRL group||0|-1|0.486
71134072|NCT02267538|141770689|OTHER||Median Difference (Final Values)|0.0||||0.414|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the seventh row in Outcome 4, i.e., Pain score in Day 2 after surgery, with coughing between DEX Group and CTRL group||0|-1|0.414
71134073|NCT02267538|141770689|OTHER||Median Difference (Final Values)|0.0||||0.187|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the eighth row in Outcome 4, i.e., Pain score in Day 3 after surgery, with coughing between DEX Group and CTRL group||0|-1|0.187
71134074|NCT02267538|141770689|OTHER||Median Difference (Final Values)|0.0||||0.127|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the ninth row in Outcome 4, i.e., Pain score in Day 4 after surgery, with coughing between DEX Group and CTRL group||0|-1|0.127
70947882|NCT02366143|141396666|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.921||||0.6053|TWO_SIDED|95.0|0.675|1.258|||Log Rank|||Arm and/or Shoulder Pain in ITT-WT||1.258|0.675|0.6053
70947883|NCT02366143|141396666|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.829||||0.3134|TWO_SIDED|95.0|0.576|1.194|||Log Rank|||Pain in Chest in ITT-WT Population||1.194|0.576|0.3134
70861561|NCT05323656|141209594|SUPERIORITY||LS Mean Difference|10.84|STANDARD_ERROR_OF_MEAN|8.37||0.2135|TWO_SIDED|80.0|-0.34|22.02|||ANCOVA||The LS Mean difference is for the Setanaxib Group minus the Placebo Group.|Null Hypothesis: Mean difference in postbaseline number of regulatory T-cells in tumour tissue does not differ between treatment groups. ANCOVA model is on postbaseline number of regulatory T-cells in tumour tissue level with a fixed factor for treatment and a covariate for baseline.||22.02|-0.34|0.2135
70947884|NCT02366143|141396666|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.91||||0.6115|TWO_SIDED|95.0|0.633|1.309|||Log Rank|||Pain in Chest in ITT-WT Population||1.309|0.633|0.6115
70947885|NCT00575042|141396679|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Sample size calculation estimated that with 20 patients, and assuming a 10% drop-out rate, the study would have 80% power to detect a response rate in 35% or more of the study patients. A two-sided p value\<0.05 was considered statistically significant.||||<0.0001
71134075|NCT02267538|141770689|OTHER||Median Difference (Final Values)|0.0||||0.378|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the tenth row in Outcome 4, i.e., Pain score in Day 5 after surgery, with coughing between DEX Group and CTRL group||0|0|0.378
71134076|NCT02267538|141770690|OTHER||Median Difference (Final Values)|0.0||||0.777|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the first row in Outcome 5, i.e., subjective sleep quality in Day 1 after surgery, between DEX Group and CTRL group||0|0|0.777
71134077|NCT02267538|141770690|OTHER||Median Difference (Final Values)|0.0||||0.919|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the second row in Outcome 5, i.e., subjective sleep quality in Day 2 after surgery, between DEX Group and CTRL group||1|-1|0.919
71134078|NCT02267538|141770690|OTHER||Median Difference (Final Values)|0.0||||0.835|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the third row in Outcome 5, i.e., subjective sleep quality in Day 3 after surgery, between DEX Group and CTRL group||0|0|0.835
71134079|NCT02267538|141770690|OTHER||Median Difference (Final Values)|0.0||||0.321|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the fourth row in Outcome 5, i.e., subjective sleep quality in Day 4 after surgery, between DEX Group and CTRL group||0|0|0.321
71134080|NCT02267538|141770690|OTHER||Median Difference (Final Values)|0.0||||0.174|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the fifth row in Outcome 5, i.e., subjective sleep quality in Day 5 after surgery, between DEX Group and CTRL group||0|0|0.174
71134081|NCT02267538|141770691|OTHER||Hazard Ratio (HR)|1.03||||0.788|TWO_SIDED|95.0|0.82|1.31|||Log Rank|||||1.31|0.82|0.788
71134082|NCT02267538|141770692|OTHER||Hazard Ratio (HR)|0.97||||0.826|TWO_SIDED|95.0|0.77|1.23|||Log Rank|||||1.23|0.77|0.826
71134083|NCT02871635|141770743|OTHER||Risk Ratio (RR)|0.945|||||TWO_SIDED|90.0|0.87|1.028|||||BI 695501 as numerator Humira EU as denominator|Was analyzed using a log-linked binomial model, described as: response to treatment at Week 4 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)||1.028|0.870|
71134084|NCT02871635|141770743|OTHER||Risk Ratio (RR)|0.945|||||TWO_SIDED|95.0|0.856|1.044|||||BI 695501 as numerator Humira EU as denominator|Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 4 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)||1.044|0.856|
71134085|NCT02871635|141770744|OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|90.0|0.871|1.148|||||BI 695501 as numerator Humira EU as denominator|Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 24 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)||1.148|0.871|
71134086|NCT02871635|141770744|OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.848|1.178|||||BI 695501 as numerator Humira EU as denominator|Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 24 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)||1.178|0.848|
71134087|NCT02871635|141770745|OTHER||Risk Ratio (RR)|0.9|||||TWO_SIDED|90.0|0.751|1.078|||||BI 695501 as numerator Humira EU as denominator|Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 24 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)||1.078|0.751|
71134088|NCT02871635|141770745|OTHER||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.725|1.116|||||BI 695501 as numerator Humira EU as denominator|Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 24 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)||1.116|0.725|
71134089|NCT00412893|141770778|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The upper bound of the 95% CI for the treatment difference was compared to the protocol prespecified non-inferiority margin of 10%. If the upper bound was smaller than 10%, isavuconazole was declared as non-inferior to voriconazole with respect to the primary outcome measure.|Adjusted Treatment Difference|-1.0|||||TWO_SIDED|95.0|-7.759|5.683|||||The treatment difference (isavuconazole minus voriconazole) was calculated using a stratified Cochran-Mantel-Haenszel (CMH) method. The strata included Geographical Regions, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Approximately 255 patients per group were to be enrolled to ensure at least 80% power to demonstrate that the upper bound of the 95% confidence interval (CI) for a treatment difference in favor of the comparator was no larger than 10%.||5.683|-7.759|
71134090|NCT00412893|141770779|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|1.6|||||TWO_SIDED|95.0|-9.336|12.572|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison||12.572|-9.336|
71134091|NCT00412893|141770779|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|-0.5|||||TWO_SIDED|95.0|-11.277|10.329|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison||10.329|-11.277|
71134092|NCT00412893|141770779|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|8.2|||||TWO_SIDED|95.0|-1.993|18.379|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison||18.379|-1.993|
71134093|NCT00412893|141770780|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|-1.4|||||TWO_SIDED|95.0|-9.15|6.34|||||The treatment difference (isavuconazole minus voriconazole) was calculated using a stratified Cochran-Mantel-Haenszel (CMH) method. The strata included Geographical Regions, Allogeneic BMT Status and Uncontrolled Malignancy Status.|||6.340|-9.150|
71134094|NCT00412893|141770782|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|0.4|||||TWO_SIDED|95.0|-10.64|11.531|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment Comparison||11.531|-10.640|
70861562|NCT05323656|141209598|SUPERIORITY||Hazard Ratio (HR)|0.448|||||TWO_SIDED|80.0|0.24|0.85||||||No formal test of significance undertaken.||0.85|0.24|
71134095|NCT00412893|141770782|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|-5.8|||||TWO_SIDED|95.0|-17.368|5.802|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison||5.802|-17.368|
71134096|NCT00412893|141770782|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|0.3|||||TWO_SIDED|95.0|-11.116|11.758|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison||11.758|-11.116|
71134097|NCT00412893|141770783|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|3.8|||||TWO_SIDED|95.0|-7.429|15.087|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison||15.087|-7.429|
71134098|NCT00412893|141770783|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|-0.7|||||TWO_SIDED|95.0|-11.917|10.586|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 Comparison||10.586|-11.917|
71134099|NCT00412893|141770783|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|9.1|||||TWO_SIDED|95.0|-1.624|19.83|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 Comparison||19.830|-1.624|
71134100|NCT00412893|141770784|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|5.7|||||TWO_SIDED|95.0|-4.936|16.268|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison||16.268|-4.936|
71134101|NCT00412893|141770784|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|5.3|||||TWO_SIDED|95.0|-5.338|16.032|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison||16.032|-5.338|
71134102|NCT00412893|141770784|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|9.0|||||TWO_SIDED|95.0|-1.231|19.186|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison||19.186|-1.231|
71134103|NCT00412893|141770785|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|5.0|||||TWO_SIDED|95.0|-6.043|16.026|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison||16.026|-6.043|
71134104|NCT00412893|141770785|SUPERIORITY_OR_OTHER_LEGACY||Adjusted treatment Difference|0.2|||||TWO_SIDED|95.0|-10.873|11.22|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison||11.220|-10.873|
71134105|NCT00412893|141770785|SUPERIORITY_OR_OTHER_LEGACY||Adjusted treatment Difference|4.7|||||TWO_SIDED|95.0|-6.533|15.939|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison||15.939|-6.533|
71134106|NCT00412893|141770786|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|4.4|||||TWO_SIDED|95.0|-8.429|17.218|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison||17.218|-8.429|
71134107|NCT00412893|141770786|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|-2.5|||||TWO_SIDED|95.0|-15.071|10.073|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison||10.073|-15.071|
71134108|NCT00412893|141770786|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|2.9|||||TWO_SIDED|95.0|-8.633|14.499|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison||14.499|-8.633|
71134109|NCT00412893|141770787|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|6.3|||||TWO_SIDED|95.0|-5.145|17.696|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison||17.696|-5.145|
71134110|NCT00412893|141770787|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|8.0|||||TWO_SIDED|95.0|-3.335|19.356|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison||19.356|-3.335|
70861563|NCT05323656|141209601|SUPERIORITY||Mean Difference (Final Values)|17.76|STANDARD_ERROR_OF_MEAN|9.4||0.0782|TWO_SIDED|80.0|5.17|30.36|||ANCOVA|The LS Mean difference is for the Setanaxib Group minus the Placebo Group.||Null Hypothesis: Mean difference in postbaseline PD-L1 combined positive score (CPS) does not differ between treatment groups. ANCOVA model is on postbaseline PD-L1 CPS with a fixed factor for treatment and a covariate for baseline. Threshold for statistical significance = 0.2.||30.36|5.17|0.0782
70861564|NCT05323656|141209602|OTHER||Mean Difference (Net)|0.11|STANDARD_DEVIATION|0.578||0.22|TWO_SIDED||||||Wilcoxon signed rank test|||Within group test of hypothesis that screening and week 9 values are equal.||||0.22
70861565|NCT05323656|141209602|OTHER||Mean Difference (Net)|-0.18|STANDARD_DEVIATION|0.395||0.2|TWO_SIDED||||||Wilcoxon signed rank test|||Within group test of hypothesis that screening and week 9 values are equal.||||0.20
70861566|NCT05323656|141209603|OTHER||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.069||0.037|TWO_SIDED||||||Wilcoxon signed rank test|||Within group test of hypothesis that screening and week 9 values are equal.||||0.037
70861567|NCT05323656|141209603|OTHER||Mean Difference (Net)|-0.02|STANDARD_DEVIATION|0.039||0.123|TWO_SIDED||||||Wilcoxon signed rank test|||Within group test of hypothesis that screening and week 9 values are equal.||||0.123
70861568|NCT05323656|141209604|OTHER||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.017||0.41|TWO_SIDED||||||Wilcoxon signed rank test|||Within group test of hypothesis that screening and week 9 values are equal.||||0.41
70861569|NCT05323656|141209604|OTHER||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.023||0.11|TWO_SIDED||||||Wilcoxon signed rank test|||Within group test of hypothesis that screening and week 9 values are equal.||||0.11
70861570|NCT02398409|141209611|SUPERIORITY||Mean Difference (Net)|0.016|STANDARD_ERROR_OF_MEAN|0.117||0.8407|TWO_SIDED|||||Adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression.|Mixed Models Analysis|||12 weeks compared to Baseline (BL)||||.8407
71134111|NCT00412893|141770787|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|5.1|||||TWO_SIDED|95.0|-6.187|16.332|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison||16.332|-6.187|
70861571|NCT02398409|141209611|SUPERIORITY||Median Difference (Net)|0.201|STANDARD_ERROR_OF_MEAN|0.12||0.015|TWO_SIDED|||||Adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression.|Mixed Models Analysis|||At 6 months compared to BL||||.0150
70861572|NCT02398409|141209611|SUPERIORITY||Median Difference (Net)|0.114|STANDARD_ERROR_OF_MEAN|0.188||0.8373|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||1 year compared BL||||.8373
70861573|NCT02398409|141209612|SUPERIORITY||Median Difference (Net)|0.016|STANDARD_ERROR_OF_MEAN|0.173||0.6445|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||12 weeks compared to BL||||.6445
70861574|NCT02398409|141209612|SUPERIORITY||Median Difference (Net)|0.033|STANDARD_ERROR_OF_MEAN|0.158||0.5247|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||6 months compared to BL||||.5247
70861575|NCT02398409|141209612|SUPERIORITY||Median Difference (Net)|0.1224|STANDARD_ERROR_OF_MEAN|0.187||0.9974|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||1 year compared to BL||||.9974
70861576|NCT02398409|141209613|SUPERIORITY||Median Difference (Net)|0.054|STANDARD_ERROR_OF_MEAN|0.087||0.1918|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||12 weeks compared to BL||||.1918
70861577|NCT02398409|141209613|SUPERIORITY||Median Difference (Net)|0.046|STANDARD_ERROR_OF_MEAN|0.078||0.9212|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||6 months compared to BL||||.9212
70861578|NCT02398409|141209613|SUPERIORITY||Median Difference (Net)|0.026|STANDARD_ERROR_OF_MEAN|0.083||0.2358|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||1 year compared to BL||||.2358
70861579|NCT02398409|141209614|SUPERIORITY|adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Median Difference (Net)|0.008|STANDARD_ERROR_OF_MEAN|0.168||0.1107|TWO_SIDED||||||Mixed Models Analysis|||12 weeks compared to BL||||.1107
70861580|NCT02398409|141209614|SUPERIORITY|adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Median Difference (Net)|0.251|STANDARD_ERROR_OF_MEAN|0.211||0.0562|TWO_SIDED||||||Mixed Models Analysis|||6 months compared to BL||||.0562
70861581|NCT02398409|141209614|SUPERIORITY||Median Difference (Net)|0.226|STANDARD_ERROR_OF_MEAN|0.218||0.8579|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||1 year compared to BL||||.8579
70861582|NCT03963401|141209633|SUPERIORITY||Mean Difference (Final Values)|21.23|STANDARD_ERROR_OF_MEAN|10.51||0.1172|TWO_SIDED|90.0|3.94|38.52|||Normal approximation, Dunnett's method|||||38.52|3.94|0.1172
70861583|NCT03963401|141209633|SUPERIORITY||Median Difference (Final Values)|23.38|STANDARD_ERROR_OF_MEAN|8.58||0.0197|TWO_SIDED|90.0|9.26|37.5|||Normal approximation, Dunnett's Method|||||37.50|9.26|0.0197
70861584|NCT03963401|141209633|SUPERIORITY||Median Difference (Final Values)|31.29|STANDARD_ERROR_OF_MEAN|8.29||0.0006|TWO_SIDED|90.0|17.65|44.93|||Normal approximation, Dunnett's Method|||||44.93|17.65|0.0006
70861585|NCT03963401|141209634|SUPERIORITY||Mean Difference (Final Values)|20.95|STANDARD_ERROR_OF_MEAN|11.09||0.0588|TWO_SIDED|90.0|2.72|39.19|||Normal approximation method|||||39.19|2.72|0.0588
70861586|NCT03963401|141209634|SUPERIORITY||Median Difference (Final Values)|26.31|STANDARD_ERROR_OF_MEAN|8.87||0.003|TWO_SIDED|90.0|11.72|40.9|||Normal approximation method|||||40.90|11.72|0.0030
70861587|NCT03963401|141209634|SUPERIORITY||Median Difference (Final Values)|31.21|STANDARD_ERROR_OF_MEAN|8.68||0.0003|TWO_SIDED|90.0|16.93|45.5|||Normal approximation method|||||45.50|16.93|0.0003
70872140|NCT03808493|141229521|EQUIVALENCE|For log-transformed (natural log) Tmax, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.2142|||||TWO_SIDED|90.0|0.0558|0.3725||||||||0.3725|0.0558|
71134112|NCT00853151|141770789|SUPERIORITY_OR_OTHER|||||||0.623||90.0||||p-value is for LY2428757 plus TT223 3 mg versus LY2428757 plus TT223 placebo.|Mixed Models Analysis|Model included treatment, baseline therapy, strata, visit, and treatment-by-visit interaction, and continuous fixed covariate of baseline HbA1c.||||||0.623
70861588|NCT00910988|141209668|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||This p-value corresponds to the two way interaction between time and order and is not adjusted for multiple comparisons. The a priori threshold for statistical significance is alpha equal to 0.05. There was no 3 way interaction.|ANCOVA|Repeated measures ANCOVA with time as the repeated measure, drug assignment as a fixed factor, and order as a fixed factor.||The hypothesis being tested is whether there is a significant effect of one or both antipsychotics on whole body insulin sensitivity. Sample size was calculated using power calculations to detect significant effects of treatment on insulin sensitivity. Drug assignment is a 2-level fixed factor (olanzapine vs ziprasidone) as is order (drug first vs placebo first). Baseline of the dependent variable as well as baseline DEXA total fat were entered into the model as covariates.||||0.001
70861589|NCT00910988|141209671|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED|95.0||||This p-value corresponds to the 3 way interaction between time, drug (olanzapine vs ziprasidone), and order (drug first vs placebo first) and is not adjusted for multiple comparisons.|ANCOVA|||The null hypothesis is that olanzapine and ziprasidone would result in acute decreases in insulin sensitivity compared to placebo at adipose tissue, which was measured by evaluating the rate of appearance of labeled glycerol. The alternative hypothesis is that olanzapine, but not ziprasidone, would result in acute decreases in insulin sensitivity compared to placebo at adipose tissue.||||0.57
70861590|NCT03911843|141209692|SUPERIORITY||Mean Difference (Net)|-0.14|||<|0.05|TWO_SIDED|95.0||||the p-value of significance was calculated using the analysis system|Wilcoxon (Mann-Whitney)|||||||<0.05
70861591|NCT03911843|141209692|SUPERIORITY||Mean Difference (Net)|-0.14|||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
70861592|NCT03911843|141209693|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70861593|NCT03911843|141209694|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
70861594|NCT01907100|141209695|OTHER||Hazard Ratio (HR)|0.555||||0.0174|TWO_SIDED|95.0|0.34|0.907|||Proportional hazards mode||Hazard ratio, confidence interval and p-value obtained from proportional hazards model stratified by tumour histology (epithelioid vs. biphasic).|Phase II Part||0.907|0.340|0.0174
70861595|NCT01907100|141209695|OTHER||Hazard Ratio (HR)|1.01||||0.543|TWO_SIDED|95.0|0.79|1.3||one-sided p-value|Proportional hazards model||Hazard ratio, confidence interval and p-value obtained from a non-stratified proportional hazards model.|"Phase III part:~A Cox proportional hazards model was fitted to estimate hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) for the comparison of treatment arms (Nintedanib vs Placebo).~If the hazard ratio is below 1 then it favours nintedanib."||1.30|0.79|0.5430
70947886|NCT03898700|141396684|OTHER||Median Difference (Final Values)|2.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This one-group feasibility study examined outcomes of coaching using descriptive statistics (changed score) and the Wilcoxon signed-rank test. A changed score of 2 points reflects clinical significance. The Wilcoxon was used to determine statistical significance. Performance scores from 31 coaching goals across 7 informal caregivers were used for analysis.||||<0.001
70861596|NCT01907100|141209696|OTHER||Hazard Ratio (HR)|0.782||||0.4132|TWO_SIDED|95.0|0.433|1.412|||Proportional hazards mode||Hazard ratio, confidence interval and p-value obtained from proportional hazards model stratified by tumour histology (epithelioid vs. biphasic).|Phase II||1.412|0.433|0.4132
70861597|NCT01907100|141209696|OTHER||Hazard Ratio (HR)|1.12||||0.7306|TWO_SIDED|95.0|0.79|1.58||one-sided p-value|Proportional hazards model||Hazard ratio, confidence interval and p-value obtained from a non-stratified proportional hazards model.|"Phase III:~A Cox proportional hazards model was fitted to estimate hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) for the comparison of treatment arms (Nintedanib vs Placebo).~If the hazard ratio is below 1 then it favours nintedanib."||1.58|0.79|0.7306
70861598|NCT01907100|141209697|OTHER||Odds Ratio (OR)|1.09||||0.3189|TWO_SIDED|95.0|0.76|1.58||one-sided p-value|Regression, Logistic|Odds ratio and one-sided p-value are obtained from an un-adjusted logistic regression model (Nintedanib vs Placebo).|Odds ratio above 1 favours nintedanib.||Exact 95% CI by Clopper and Pearson.|1.58|0.76|0.3189
70861599|NCT01907100|141209698|OTHER||Odds Ratio (OR)|0.79||||0.7512|TWO_SIDED|95.0|0.4|1.55||one-sided p-value|Regression, Logistic|Odds ratio and one-sided p-value are obtained from an un-adjusted logistic regression model (Nintedanib vs Placebo).|Odds ratio above 1 favours nintedanib.|||1.55|0.40|0.7512
70861600|NCT03635788|141209699|SUPERIORITY|The study had approximately 80% power to show superiority of the LA ART compared to daily SOC with respect to the Step 2, week 48, cumulative probability of regimen failure|Cumulative probability difference|-18.4|||||TWO_SIDED|98.4|-32.4|-4.3|||||Treatment difference was calculated as LA-ART minus SOC. 98.4% is nominal confidence interval.|Treatment comparison was conducted by cumulative probability of regimen failure in Step 2 up to Step 2 Week 48 visit by treatment arm. The treatment difference was assessed using the 95% repeated confidence interval adjusted for interim efficacy analyses, i.e., a nominal 98.4% confidence interval.||-4.3|-32.4|
70861601|NCT03635788|141209700|SUPERIORITY|The study had at least 80% power to show superiority of the LA ART compared to daily SOC with respect to the Step 2, week 48, cumulative probability of virologic failure|cumulative probability difference|-21.4|||||TWO_SIDED|98.4|-33.5|-9.3|||||Treatment difference was calculated as LA-ART minus SOC.98.4% is nominal confidence interval.|Treatment comparison was conducted by cumulative probability of virologic failure in Step 2 up to Step 2 Week 48 visit by treatment arm. The treatment difference was assessed using the 95% repeated confidence interval adjusted for interim efficacy analyses, i.e., a nominal 98.4% confidence interval.||-9.3|-33.5|
70861602|NCT03635788|141209701|SUPERIORITY||cumulative probability diffeence|-19.2|||||TWO_SIDED|98.4|-31.6|-6.9||||||Treatment comparison was conducted by cumulative probability of treatment-related failure in Step 2 up to Step 2 Week 48 visit by treatment arm. The treatment difference was assessed using the 95% repeated confidence interval adjusted for interim efficacy analyses, i.e., a nominal 98.4% confidence interval.|Treatment difference was calculated as LA-ART minus SOC.98.4% is nominal confidence interval.|-6.9|-31.6|
70861603|NCT03635788|141209702|SUPERIORITY|The proportions of participants with HIV-1 RNA ≥ 50 copies/ml was compared by Fisher's Exact Test.|Mean Difference (Final Values)|-21.8|||<|0.001|TWO_SIDED|95.0|-35.6|-8.1|||Fisher Exact||||Treatment difference in the proportions of participants with HIV-1 RNA ≥ 50 copies/ml was calculated as LA-ART minus SOC.|-8.1|-35.6|<0.001
71134113|NCT00853151|141770789|SUPERIORITY_OR_OTHER|||||||0.809||95.0||||p-value is for LY2428757 plus TT223 2 mg versus LY2428757 plus TT223 placebo.|Mixed Models Analysis|Model included treatment, baseline therapy, strata, visit, and treatment-by-visit interaction, and continuous fixed covariate of baseline HbA1c.||||||0.809
71134114|NCT04473963|141770844|NON_INFERIORITY|Non-inferiority between subjects Randomized to Treatment vs subjects Randomized to Control||||||0.277|||||||Chi-squared|||||||0.277
71134115|NCT04473963|141770846|EQUIVALENCE|"Equivalence between subjects Randomized to Control and subjects Randomized to Treatment"||||||0.042|||||||Kaplan-Meyer Log Rank|||||||0.042
70861604|NCT03635788|141209703|SUPERIORITY||Mean Difference (Final Values)|-24.5|||<|0.001|TWO_SIDED|95.0|-36.1|-12.8|||Fisher Exact||Difference in the proportions of participants with HIV-1 RNA ≥ 200 copies was calculated as LA-ART minus SOC.|The proportions of participants with HIV-1 RNA ≥ 200 copies/ml was compared by Fisher's Exact Test.||-12.8|-36.1|<0.001
71134116|NCT04473963|141770851|EQUIVALENCE|"Equivalence between procedure time of subjects Randomized to Treatment and subjects Randomized to Control. The Not-Randomized group was not included in the analysis."|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71134117|NCT02123849|141770852|NON_INFERIORITY|The non-inferiority margin is 10% of the coefficient of variation (i.e., standard deviation divided by mean) which means that the changes in the signature score in the intermittent arm is no less than 90% of the coefficient of variation of the changes in the signature score in the continuous arm.||||||0.04|||||||t-test, 1 sided|||||||0.04
71134118|NCT02123849|141770853|OTHER|||||||0.84|||||||t-test, 2 sided|||||||0.84
71134119|NCT02123849|141770854|OTHER|||||||0.61|||||||t-test, 2 sided|||||||0.61
71134120|NCT02123849|141770855|OTHER|||||||1|||||||Fisher Exact|||||||1.00
71134121|NCT02123849|141770856|OTHER|||||||0.42|||||||t-test, 2 sided|||||||0.42
71134122|NCT02123849|141770857|NON_INFERIORITY|The non-inferiority margin is 10% of the coefficient of variation (i.e., standard deviation divided by mean) which means that the changes in the signature score in the intermittent arm is no less than 90% of the coefficient of variation of the changes in the signature score in the continuous arm.||||||0.97|||||||t-test, 1 sided|||||||0.97
71134123|NCT02123849|141770858|NON_INFERIORITY|The non-inferiority margin is 10% of the coefficient of variation (i.e., standard deviation divided by mean) which means that the changes in the signature score in the intermittent arm is no less than 90% of the coefficient of variation of the changes in the signature score in the continuous arm.||||||0.97|||||||t-test, 1 sided|||||||0.97
71134124|NCT02123849|141770859|NON_INFERIORITY|The non-inferiority margin is 10% of the coefficient of variation (i.e., standard deviation divided by mean) which means that the changes in the signature score in the intermittent arm is no less than 90% of the coefficient of variation of the changes in the signature score in the continuous arm.||||||0.06|||||||t-test, 1 sided|||||||0.06
71134125|NCT01426958|141770912|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|119.3|STANDARD_DEVIATION|11.5||0.1009|TWO_SIDED|90.0|112.239|126.811||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||126.811|112.239|0.1009
71134126|NCT01426958|141770912|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|110.23|STANDARD_DEVIATION|10.9||0.0009|TWO_SIDED|90.0|103.837|117.006||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||117.006|103.837|0.0009
71134127|NCT01426958|141770912|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|91.9|STANDARD_DEVIATION|11.6||0.0004|TWO_SIDED|90.0|86.519|97.614||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||97.614|86.519|0.0004
71134128|NCT01426958|141770913|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|104.06|STANDARD_DEVIATION|14.2||0.0002|TWO_SIDED|90.0|96.681|112.002||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||112.002|96.681|0.0002
71134129|NCT01426958|141770913|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|105.09|STANDARD_DEVIATION|16.1||0.0012|TWO_SIDED|90.0|96.425|114.53||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||114.530|96.425|0.0012
71134130|NCT01426958|141770913|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|99.75|STANDARD_DEVIATION|12.8||0|TWO_SIDED|90.0|93.328|106.61||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||106.610|93.328|0.0000
71134131|NCT01426958|141770914|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|118.56|STANDARD_DEVIATION|11.5||0.0702|TWO_SIDED|90.0|111.712|125.822||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||125.822|111.712|0.0702
71134132|NCT01426958|141770914|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|110.76|STANDARD_DEVIATION|10.0||0.0005|TWO_SIDED|90.0|104.936|116.913||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||116.913|104.936|0.0005
71134133|NCT01426958|141770914|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|92.46|STANDARD_DEVIATION|11.9||0.0003|TWO_SIDED|90.0|86.928|98.341||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||98.341|86.928|0.0003
71134134|NCT02968368|141770915|SUPERIORITY||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.21||0.0149|TWO_SIDED|95.0|0.102|0.93|||ANCOVA|||||0.930|0.102|0.0149
71134135|NCT02968368|141770920|SUPERIORITY||Mean Difference (Final Values)|39.03|STANDARD_ERROR_OF_MEAN|11.097||0.0006|TWO_SIDED|95.0|17.07|60.992|||ANCOVA|||||60.992|17.070|0.0006
71134136|NCT02968368|141770923|SUPERIORITY||Mean Difference (Final Values)|4.46|STANDARD_ERROR_OF_MEAN|1.282||0.0007|TWO_SIDED|95.0|1.928|7.001|||ANCOVA|||||7.001|1.928|0.0007
71134137|NCT02968368|141770924|SUPERIORITY||Mean Difference (Final Values)|1.86|STANDARD_ERROR_OF_MEAN|0.708||0.0098|TWO_SIDED|95.0|0.457|3.261|||ANCOVA|||||3.261|0.457|0.0098
71134138|NCT02859246|141770927|SUPERIORITY||||||<|0.04||||||A two tail P value of less than 0.05 was considered statistically significant.|Wilcoxon (Mann-Whitney)|||||||<0.04
71134139|NCT02859246|141770928|SUPERIORITY||||||<|0.2||||||A two tail P value of less than 0.05 was considered statistically significant.|Wilcoxon (Mann-Whitney)|||||||< 0.2
71134140|NCT05280717|141770935|OTHER||Ratio of geometric least square mean|0.9821|||||TWO_SIDED|90.0|0.8825|1.093|||||The ratio estimate and 90% confidence interval were obtained from an Analysis of covariance (ANCOVA) model, with AUC(D1- 29) as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.0930|0.8825|
71134141|NCT05280717|141770936|OTHER||Ratio of geometric least square mean|1.1258|||||TWO_SIDED|90.0|1.0108|1.2539|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with Cmax as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.2539|1.0108|
71134142|NCT05280717|141770939|OTHER||Ratio of geometric least square mean|1.876|||||TWO_SIDED|90.0|1.6391|2.1472|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with AUC(D1-29) as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||2.1472|1.6391|
71134143|NCT05280717|141770939|OTHER||Ratio of geometric least square mean|1.5991|||||TWO_SIDED|90.0|1.4086|1.8153|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with AUC(D1-29) as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.8153|1.4086|
70872141|NCT03808493|141229522|EQUIVALENCE|For log-transformed (natural log) MRT∞,ev, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.0311|||||TWO_SIDED|90.0|0.0022|0.0599||||||||0.0599|0.0022|
71134144|NCT05280717|141770940|OTHER||Ratio of geometric least square mean|2.0798|||||TWO_SIDED|90.0|1.8223|2.3737|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with Cmax as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||2.3737|1.8223|
71134145|NCT05280717|141770940|OTHER||Ratio of geometric least square mean|1.6955|||||TWO_SIDED|90.0|1.4913|1.9276|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with Cmax as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.9276|1.4913|
71134146|NCT05280717|141770945|OTHER||Ratio of geometric least square mean|0.9476|||||TWO_SIDED|90.0|0.8578|1.0469|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with AUCinf as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.0469|0.8578|
71134147|NCT05280717|141770945|OTHER||Ratio of geometric least square mean|1.5482|||||TWO_SIDED|90.0|1.377|1.7407|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with AUCinf as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.7407|1.3770|
71134148|NCT05280717|141770945|OTHER||Ratio of geometric least square mean|1.4167|||||TWO_SIDED|90.0|1.2627|1.5894|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with AUCinf as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.5894|1.2627|
71134149|NCT00080301|141770953|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.0003||95.17|0.64|0.88||Test was stratified by 1) presence of visceral metastases in liver or lung, 2) minimum of either doxorubicin 420 mg/m2 or epirubicin 360 mg/m2, and relapse \> 6 months in adjuvant setting, and 3) prior chemotherapy for metastatic disease. (yes/no)|Log Rank|95.17% confidence interval is adjusted for the interim analysis.||Study required 615 events to achieve 90% power to detect a hazard ratio of 0.77 using a 2-sided α = 0.05 log-rank test. The analysis was a comparison between the 2 treatment arms using a 2-sided α=0.0483 log-rank test (adjusted for an interim analysis using the O'Brien Fleming spending function) to reject the null hypothesis of equality of progression free survival. The analysis was conducted when 639 events (310 in combination:329 in capecitabine) were observed from the 752 randomized patients.||0.88|0.64|.0003
71134150|NCT00080301|141770954|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.15|||<|0.0001||95.0|2.2|4.5|||Cochran-Mantel-Haenszel|||The study had 95 percent power to detect a significant difference in ORR if the true response rate was 32 percent in the combination arm and 20 percent in the capecitabine arm.||4.50|2.20|<.0001
70861605|NCT03635788|141209708|SUPERIORITY||Cumulative probability difference|-8.4|||||TWO_SIDED|98.4|-21.3|4.5|||||Treatment difference in cumulative of permanent treatment discontinuation was calculated as LA-ART minus SOC.98.4% is nominal confidence interval.|Treatment comparison was conducted by cumulative probability of permanent treatment discontinuation in Step 2 up to Step 2 Week 48 visit by treatment arm. The treatment difference was assessed using the 95% repeated confidence interval adjusted for interim efficacy analyses, i.e., a nominal 98.4% confidence interval.||4.5|-21.3|
70861606|NCT03811002|141209750|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.5819|TWO_SIDED|95.0|0.82|1.34|||Log Rank|Stratified by radiation schedule (BID vs daily), chemotherapy (cisplatin vs carboplatin), and sex (male vs female). 1-sided significance level 0.025.|Stratified by radiation schedule (BID vs daily), chemotherapy (cisplatin vs carboplatin), and sex (male vs female). Reference level = Arm 1.|Assuming exponentially distributed survival times, 480 eligible patients accrued uniformly over 48 months months) with 26 months additional follow-up after the last accrued patient would provide at least 85% power to detect a hazard ratio of 0.71 (median survival times of 38 months \[Arm I\] vs. 27 months \[Arm II\]) at a one-sided significance level of 0.025, after adjusting for type 1 error using group sequential methods for two interim analyses.||1.34|0.82|0.5819
70861607|NCT03811002|141209751|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.8|1.21|||Log Rank||Stratified by radiation schedule (BID vs daily), chemotherapy (cisplatin vs carboplatin), and sex (male vs female). Reference level = Arm 1.|||1.21|0.80|
70861608|NCT03811002|141209754|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.52|1.41|||||Cause-specific hazard ratio stratified by radiation schedule (BID vs daily), chemotherapy (cisplatin vs carboplatin), and sex (male vs female). Reference level = Arm 1.|||1.41|0.52|
70861609|NCT03811002|141209755|SUPERIORITY||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.76|1.2|||||Stratified by radiation schedule (BID vs daily), chemotherapy (cisplatin vs carboplatin), and sex (male vs female). Reference level = Arm I.|||1.20|0.76|
70861610|NCT04191187|141209765|SUPERIORITY||PFS at 18 Months|70.8||||0.002|ONE_SIDED|90.0|59.2|||One sided log rank test|Log Rank||||||59.2|0.002
70861611|NCT01083485|141209782|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.5|0.3||A P value was not part of the analysis plan. A within SD 1.7, and expected treatment difference of 0 and a non-inferiority margin was -1.0 meaning that OXN PR can be one unit inferior to OXY PR and still be considered non-inferior.|ANCOVA|The primary efficacy endpoint was analysed on the PP data using a mixed-model repeat measure analysis of covariance RMANCOVA.||The sample size was calculated for a significance level of 2.5% (1 sided) with 90% power. A within SD 1.7, and expected treatment difference of 0 and a non-inferiority margin of 1.0 were assumed.||0.3|-0.5|
70861612|NCT02247531|141209791|SUPERIORITY||Difference in Adjusted Means|0.157||||0.0479|TWO_SIDED|95.0|0.001|0.313|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.313|0.001|0.0479
70861613|NCT02247531|141209791|SUPERIORITY||Difference in Adjusted Means|0.087||||0.2739|TWO_SIDED|95.0|-0.069|0.243|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.243|-0.069|0.2739
70861614|NCT02247531|141209792|SUPERIORITY||Difference in Adjusted Means|-0.4||||0.84|TWO_SIDED|95.0|-4.8|3.9|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline number of absolute scotomatous points, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||3.9|-4.8|0.8400
70861615|NCT02247531|141209792|SUPERIORITY||Difference in Adjusted Means|1.3||||0.5587|TWO_SIDED|95.0|-3.1|5.7|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline number of absolute scotomatous points, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||5.7|-3.1|0.5587
70861616|NCT02247531|141209793|SUPERIORITY||Difference in Adjusted Means|0.1||||0.8358|TWO_SIDED|95.0|-0.88|1.09|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline mean macular sensitivity, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||1.09|-0.88|0.8358
70861617|NCT02247531|141209793|SUPERIORITY||Difference in Adjusted Means|-0.26||||0.6117|TWO_SIDED|95.0|-1.25|0.74|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline mean macular sensitivity, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.74|-1.25|0.6117
70861618|NCT02247531|141209794|SUPERIORITY||Difference in Adjusted Means|0.7||||0.4651|TWO_SIDED|95.0|-1.2|2.5|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline BCVA, GA lesion location, biomarker status, and sex.||2.5|-1.2|0.4651
70861619|NCT02247531|141209794|SUPERIORITY||Difference in Adjusted Means|0.3||||0.7885|TWO_SIDED|95.0|-1.6|2.1|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline BCVA, GA lesion location, biomarker status, and sex.||2.1|-1.6|0.7885
70861620|NCT02247531|141209795|SUPERIORITY||Odds Ratio (OR)|1.1||||0.6892|TWO_SIDED|95.0|0.7|1.8|||Regression, Logistic|||||1.8|0.7|0.6892
70861621|NCT02247531|141209795|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9104|TWO_SIDED|95.0|0.6|1.6|||Regression, Logistic|||||1.6|0.6|0.9104
70861622|NCT02247531|141209796|SUPERIORITY||Difference in Adjusted Means|-0.1||||0.8931|TWO_SIDED|95.0|-1.8|1.5|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline LLVA, GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.||1.5|-1.8|0.8931
70861623|NCT02247531|141209796|SUPERIORITY||Difference in Adjusted Means|-1.1||||0.1754|TWO_SIDED|95.0|-2.8|0.5|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline LLVA, GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.||0.5|-2.8|0.1754
70861624|NCT02247531|141209797|SUPERIORITY||Odds Ratio (OR)|1.3||||0.3707|TWO_SIDED|95.0|0.7|2.2|||Regression, Logistic|||||2.2|0.7|0.3707
70861625|NCT02247531|141209797|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8382|TWO_SIDED|95.0|0.6|1.6|||Regression, Logistic|||||1.6|0.6|0.8382
70861626|NCT02247531|141209798|SUPERIORITY||Difference in Adjusted Means|1.35||||0.6841|TWO_SIDED|95.0|-5.16|7.85|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, type of reading charts, baseline BCVA of better seeing eye, biomarker status, and sex.||7.85|-5.16|0.6841
70861627|NCT02247531|141209798|SUPERIORITY||Difference in Adjusted Means|1.07||||0.7443|TWO_SIDED|95.0|-5.37|7.52|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, type of reading charts, baseline BCVA of better seeing eye, biomarker status, and sex.||7.52|-5.37|0.7443
70861628|NCT02247531|141209799|SUPERIORITY||Difference in Adjusted Means|0.12||||0.9713|TWO_SIDED|95.0|-6.28|6.52|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, biomarker status, modified baseline BCVA, and sex.||6.52|-6.28|0.9713
70861629|NCT02247531|141209799|SUPERIORITY||Difference in Adjusted Means|-1.72||||0.5945|TWO_SIDED|95.0|-8.08|4.63|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, biomarker status, modified baseline BCVA, and sex.||4.63|-8.08|0.5945
70861630|NCT02247531|141209800|SUPERIORITY||Difference in Adjusted Means|1.22||||0.2438|TWO_SIDED|95.0|-0.83|3.27|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||3.27|-0.83|0.2438
70861631|NCT02247531|141209800|SUPERIORITY||Difference in Adjusted Means|1.03||||0.3202|TWO_SIDED|95.0|-1.01|3.07|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||3.07|-1.01|0.3202
70861632|NCT02247531|141209801|SUPERIORITY||Difference in Adjusted Means|2.64||||0.0388|TWO_SIDED|95.0|0.14|5.14|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||5.14|0.14|0.0388
70861633|NCT02247531|141209801|SUPERIORITY||Difference in Adjusted Means|2.2||||0.0833|TWO_SIDED|95.0|-0.29|4.68|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||4.68|-0.29|0.0833
70861634|NCT02247531|141209802|SUPERIORITY||Difference in Adjusted Means|1.04||||0.4795|TWO_SIDED|95.0|-1.84|3.91|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||3.91|-1.84|0.4795
70861635|NCT02247531|141209802|SUPERIORITY||Difference in Adjusted Means|0.6||||0.6822|TWO_SIDED|95.0|-2.26|3.45|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||3.45|-2.26|0.6822
70861636|NCT02247531|141209803|SUPERIORITY||Difference in Adjusted Means|0.04||||0.5227|TWO_SIDED|95.0|-0.07|0.14|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline Mean FRI Index score, baseline BCVA of better seeing eye, biomarker status, and sex.||0.14|-0.07|0.5227
70861637|NCT02247531|141209803|SUPERIORITY||Difference in Adjusted Means|0.02||||0.7475|TWO_SIDED|95.0|-0.09|0.13|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline Mean FRI Index score, baseline BCVA of better seeing eye, biomarker status, and sex.||0.13|-0.09|0.7475
70861638|NCT02247531|141209804|SUPERIORITY||Difference in Adjusted Means|0.049||||0.6333|TWO_SIDED|95.0|-0.153|0.252|||MMRM|||CFI Positive: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.252|-0.153|0.6333
70861639|NCT02247531|141209804|SUPERIORITY||Difference in Adjusted Means|0.025||||0.8105|TWO_SIDED|95.0|-0.18|0.23|||MMRM|||CFI Positive: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.230|-0.180|0.8105
70861640|NCT02247531|141209804|SUPERIORITY||Difference in Adjusted Means|0.34||||0.0063|TWO_SIDED|95.0|0.097|0.584|||MMRM|||CFI Negative: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.584|0.097|0.0063
70861641|NCT02247531|141209804|SUPERIORITY||Difference in Adjusted Means|0.182||||0.1359|TWO_SIDED|95.0|-0.058|0.422|||MMRM|||CFI Negative: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.422|-0.058|0.1359
70861642|NCT04131556|141209815|EQUIVALENCE|Equivalence analysis based on confidence intervals (CIs). If the 90% CIs of the geometric mean ratios were within (0.8, 1.25), bioequivalence between the two formulations (test powder for oral suspension versus reference tablet) was to be claimed. A linear mixed effect ANOVA model with treatment, period, sequence as fixed effects and participant within sequence as a random effect was used to fit to ln-transformed PK parameters.|% Ratio of Geometric least square means|67.76|||||TWO_SIDED|90.0|59.5|77.16|||ANOVA|||||77.16|59.50|
70861643|NCT04131556|141209815|EQUIVALENCE|Equivalence analysis based on confidence intervals (CIs). If the 90% CIs of the geometric mean ratios were within (0.8, 1.25), bioequivalence between the two formulations (test powder for oral suspension versus reference tablet) was to be claimed. A linear mixed effect ANOVA model with treatment, period, sequence as fixed effects and participant within sequence as a random effect was used to fit to ln-transformed PK parameters.|% Ratio of Geometric least squares means|62.29|||||TWO_SIDED|90.0|54.73|70.9|||ANOVA|||||70.90|54.73|
70861644|NCT04131556|141209816|OTHER||Median Difference (Final Values)|1.25|||<|0.001|TWO_SIDED|90.0|0.75|1.75|||Wilcoxon signed rank test|||Statistical analysis of tmax was performed using a nonparametric test. The median difference of tmax between treatments and 90% CIs of the median differences were calculated from Hodges-Lehman estimate, and p-value was produced from Wilcoxon signed rank test.||1.75|0.75|<.001
70861645|NCT04131556|141209816|OTHER||Median Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|90.0|0.75|1.25|||Wilcoxon signed rank test|||Statistical analysis of tmax was performed using a nonparametric test. The median difference of tmax between treatments and 90% CIs of the median differences were calculated from Hodges-Lehman estimate, and p-value was produced from Wilcoxon signed rank test.||1.25|0.75|<.001
70861646|NCT04131556|141209817|EQUIVALENCE|Equivalence analysis based on confidence intervals (CIs). If the 90% CIs of the geometric mean ratios were within (0.8, 1.25), bioequivalence between the two formulations (test powder for oral suspension versus reference tablet) was to be claimed. A linear mixed effect ANOVA model with treatment, period, sequence as fixed effects and participant within sequence as a random effect was used to fit to ln-transformed PK parameters.|% Ratio of Geometric least squares means|81.27|||||TWO_SIDED|90.0|73.88|89.4|||ANOVA|||||89.40|73.88|
70861647|NCT04131556|141209817|EQUIVALENCE|Equivalence analysis based on confidence intervals (CIs). If the 90% CIs of the geometric mean ratios were within (0.8, 1.25), bioequivalence between the two formulations (test powder for oral suspension versus reference tablet) was to be claimed. A linear mixed effect ANOVA model with treatment, period, sequence as fixed effects and participant within sequence as a random effect was used to fit to ln-transformed PK parameters.|% Ratio of Geometric least squares means|78.0|||||TWO_SIDED|90.0|70.92|85.79|||ANOVA|||||85.79|70.92|
70861648|NCT04131556|141209818|EQUIVALENCE|Equivalence analysis based on confidence intervals (CIs). If the 90% CIs of the geometric mean ratios were within (0.8, 1.25), bioequivalence between the two formulations (test powder for oral suspension versus reference tablet) was to be claimed. A linear mixed effect ANOVA model with treatment, period, sequence as fixed effects and participant within sequence as a random effect was used to fit to ln-transformed PK parameters.|% Ratio of Geometric least squares means|83.52|||||TWO_SIDED|90.0|76.12|91.64|||ANOVA|||||91.64|76.12|
70861649|NCT04131556|141209818|EQUIVALENCE|Equivalence analysis based on confidence intervals (CIs). If the 90% CIs of the geometric mean ratios were within (0.8, 1.25), bioequivalence between the two formulations (test powder for oral suspension versus reference tablet) was to be claimed. A linear mixed effect ANOVA model with treatment, period, sequence as fixed effects and participant within sequence as a random effect was used to fit to ln-transformed PK parameters.|% Ratio of Geometric least squares means|80.36|||||TWO_SIDED|90.0|73.26|88.16|||ANOVA|||||88.16|73.26|
70861650|NCT04131556|141209821|OTHER||Median Difference (Final Values)|0.13||||0.006|TWO_SIDED|90.0|0.13|0.25|||Wilcoxon signed rank test|||Statistical analysis of Tlag was performed using a nonparametric test. The median difference of Tlag between treatments and 90% CIs of the median differences were calculated from Hodges-Lehman estimate, and p-value was produced from Wilcoxon signed rank test.||0.25|0.13|0.006
70861651|NCT04131556|141209821|OTHER||Median Difference (Final Values)|0.13||||0.011|TWO_SIDED|90.0|0.13|0.25|||Wilcoxon signed rank test|||Statistical analysis of Tlag was performed using a nonparametric test. The median difference of Tlag between treatments and 90% CIs of the median differences were calculated from Hodges-Lehman estimate, and p-value was produced from Wilcoxon signed rank test.||0.25|0.13|0.011
70861652|NCT00760214|141209856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.41|||<|0.001|TWO_SIDED|95.0|-11.04|-5.78||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-5.78|-11.04|<.001
70861653|NCT00760214|141209856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.03|||<|0.001|TWO_SIDED|95.0|-11.66|-6.39||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-6.39|-11.66|<.001
70861654|NCT00760214|141209857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.31|||<|0.001|TWO_SIDED|95.0|-6.85|-3.78||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-3.78|-6.85|<.001
70861655|NCT00760214|141209857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.66|||<|0.001|TWO_SIDED|95.0|-7.21|-4.12||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-4.12|-7.21|<.001
70861656|NCT00760214|141209858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.82|||<|0.001|TWO_SIDED|95.0|-7.64|-2.01||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-2.01|-7.64|<.001
70861657|NCT00760214|141209858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.47||||0.002|TWO_SIDED|95.0|-7.27|-1.66||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-1.66|-7.27|0.002
70861658|NCT00760214|141209859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.77||||0.003|TWO_SIDED|95.0|-4.61|-0.94||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-0.94|-4.61|0.003
70861659|NCT00760214|141209859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.06||||0.001|TWO_SIDED|95.0|-4.89|-1.24||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-1.24|-4.89|0.001
70947887|NCT03898700|141396684|OTHER||Median Difference (Net)|2.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This one-group feasibility study examined outcomes of coaching using descriptive statistics (changed score) and the Wilcoxon signed-rank test. A changed score of 2 points reflects clinical significance. The Wilcoxon was used to determine statistical significance. Satisfaction scores from 31 coaching goals across 7 informal caregivers were used for analysis.||||<0.001
70947888|NCT03616964|141396688|SUPERIORITY||Odds Ratio (OR)|1.07||||0.711|TWO_SIDED|95.0|0.75|1.53|||Regression, Logistic|||||1.53|0.75|0.711
70947889|NCT03616964|141396689|SUPERIORITY||Odds Ratio (OR)|1.05||||0.789|TWO_SIDED|95.0|0.73|1.5|||Regression, Logistic|||||1.50|0.73|0.789
70947890|NCT03616964|141396690|SUPERIORITY||Odds Ratio (OR)|1.1||||0.673|TWO_SIDED|95.0|0.72|1.68|||Regression, Logistic|||||1.68|0.72|0.673
70947891|NCT03616964|141396690|SUPERIORITY||Odds Ratio (OR)|1.15||||0.528|TWO_SIDED|95.0|0.75|1.75|||Regression, Logistic|||||1.75|0.75|0.528
70861660|NCT00760214|141209860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.77||||0.017|TWO_SIDED|95.0|-6.87|-0.68||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-0.68|-6.87|0.017
70861661|NCT00760214|141209860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.43||||0.029|TWO_SIDED|95.0|-6.5|-0.36||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-0.36|-6.50|0.029
70861662|NCT00760214|141209861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06||||0.052|TWO_SIDED|95.0|-4.15|0.02||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||0.02|-4.15|0.052
70861663|NCT00760214|141209861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.42||||0.022|TWO_SIDED|95.0|-4.49|-0.35||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-0.35|-4.49|0.022
70861664|NCT00760214|141209862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.53||||0.003|TWO_SIDED|95.0|-7.46|-1.59||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-1.59|-7.46|0.003
70861665|NCT00760214|141209862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.26||||0.004|TWO_SIDED|95.0|-7.18|-1.35||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-1.35|-7.18|0.004
70861666|NCT00760214|141209863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.64||||0.008|TWO_SIDED|95.0|-4.6|-0.68||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-0.68|-4.60|0.008
71134151|NCT00080301|141770957|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.1936||95.17|0.77|1.05||Test was stratified by presence of visceral metastases in liver or lung (y/n), minimum of either doxorubicin 420 mg/m2 or epirubicin 360 mg/m2, and relapse \> 6 months in adjuvant setting (y/n), and prior chemotherapy for metastatic disease (y/n).|Log Rank|Test was conducted at the α=0.05 level and no adjustments were performed.|Confidence Interval adjusted for interim analysis.|Study required 631 deaths to achieve 80% power to detect a Hazard ratio of 0.8 using a 2-sided α = 0.05 log rank test. The analysis was a comparison between the 2 treatment arms using a 2-sided α=0.05 log-rank test to reject the null hypothesis of equality of survival. The analysis was conducted when 639 deaths (318 in combination:321 in capecitabine) were observed from the 752 randomized patients.||1.05|0.77|0.1936
71134152|NCT00080301|141770959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0|||||Wei-Lachin|||There was a statistically significant difference between groups in change from baseline FBSI score favoring capecitabine. A mean change from baseline of 2.5 was considered a clinically meaningful difference (minimally important difference or MID). On-treatment mean changes in the FBSI did not reach the MID in either group.||||.0002
71134153|NCT00123123|141770962|SUPERIORITY_OR_OTHER_LEGACY|||||||0.675||95.0|||||ANOVA|||A mixed effect model was used to compare overall treatment effects between groups for repeated measures data. The group comparison for each time point was performed using ANOVA.||||0.6750
71134154|NCT02073682|141770970|NON_INFERIORITY|Edoxaban Group was considered non-inferior to the Dalteparin Group if the upper limit of the 2-sided 95% confidence interval (CI) for the Hazard Ratio (\[LMW\] Edoxaban Group to Dalteparin Group) was less than 1.5.|Cox Proportional Hazard|0.97||||0.0056|TWO_SIDED|95.0|0.696|1.359|||Cox proportional hazard|||||1.359|0.696|0.0056
71134155|NCT02073682|141770970|SUPERIORITY|The hazard ratio (HR), two-sided confidence interval (CI) and p-value are based on the Cox proportional hazard model including treatment and the two stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||||||0.8712|||||||Cox proportional hazard|||||||0.8712
71134156|NCT02073682|141770971|SUPERIORITY||Hazard Ratio (HR)|2.0||||0.0254|TWO_SIDED|95.0|1.089|3.657|||Regression, Cox|||The HR, 2-sided CI and p-value are based on the Cox regression model with counting process approach for on-treatment including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||3.657|1.089|0.0254
71134157|NCT02073682|141770972|SUPERIORITY||Cox Proportional Hazard|0.71||||0.0931|TWO_SIDED|95.0|0.476|1.059|||Cox proportional hazard|||The HR, 2-sided CI, and p-value are based on the Cox proportional hazard model including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||1.059|0.476|0.0931
70861667|NCT00760214|141209863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.98||||0.003|TWO_SIDED|95.0|-4.93|-1.04||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-1.04|-4.93|0.003
70947892|NCT03616964|141396692|SUPERIORITY||Odds Ratio (OR)|0.91||||0.761|TWO_SIDED|95.0|0.51|1.64|||Regression, Logistic|||||1.64|0.51|0.761
70861668|NCT00760214|141209864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.95|||<|0.001|TWO_SIDED|95.0|-9.12|-2.77||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-2.77|-9.12|<.001
71134158|NCT02073682|141770973|SUPERIORITY||Cox Proportional Hazard|0.56||||0.0394|TWO_SIDED|95.0|0.318|0.972|||Cox proportional hazard|||The HR, 2-sided CI, and p-value are based on the Cox proportional hazard model including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||0.972|0.318|0.0394
71134159|NCT02073682|141770974|SUPERIORITY||Cox Proportional Hazard|0.9||||0.7324|TWO_SIDED|95.0|0.502|1.624|||Cox proportional hazard|||The HR, 2-sided CI, and p-value are based on the Cox proportional hazard model including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||1.624|0.502|0.7324
71134160|NCT02073682|141770975|SUPERIORITY||Cox Proportional Hazard|1.56||||0.4873|TWO_SIDED|95.0|0.444|5.505|||Cox proportional hazard|||The HR, 2-sided CI, and p-value are based on the Cox proportional hazard model including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||5.505|0.444|0.4873
71134161|NCT02073682|141770976|SUPERIORITY||Cox Proportional Hazard|1.08||||0.4199|TWO_SIDED|95.0|0.898|1.293|||Cox proportional hazard|||The HR, 2-sided CI, and p-value are based on the Cox proportional hazard model including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||1.293|0.898|0.4199
70861669|NCT00760214|141209864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.82|||<|0.001|TWO_SIDED|95.0|-8.96|-2.67||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-2.67|-8.96|<.001
70861670|NCT00760214|141209865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.01||||0.006|TWO_SIDED|95.0|-5.15|-0.88||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-0.88|-5.15|0.006
70861671|NCT00760214|141209865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.77|||<|0.001|TWO_SIDED|95.0|-5.89|-1.65||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-1.65|-5.89|<.001
70947893|NCT03616964|141396692|SUPERIORITY||Odds Ratio (OR)|1.17||||0.611|TWO_SIDED|95.0|0.65|2.1|||Regression, Logistic|||||2.10|0.65|0.611
70861672|NCT00760214|141209866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.87|||<|0.001|TWO_SIDED|95.0|-12.15|-5.6||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-5.60|-12.15|<.001
70947894|NCT03616964|141396693|SUPERIORITY||LS Mean difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.2||0.698|TWO_SIDED|95.0|-0.47|0.32|||Mixed Models Analysis|||||0.32|-0.47|0.698
70947895|NCT03616964|141396693|SUPERIORITY||LS Mean difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.2||0.744|TWO_SIDED|95.0|-0.46|0.33|||Mixed Models Analysis|||||0.33|-0.46|0.744
71134162|NCT00855816|141770984|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED|||||A priori threshold for significance: p\<.05.|Mixed Models Analysis|Mixed model based on intent to treat sample.||Null hypothesis: there will be no differences in PTSD hyperarousal symptom changes in individuals who did receive the experimental intervention vs. those who did not .||||.27
71134163|NCT03393494|141770985|EQUIVALENCE|provides 85% power of success|Equivalence ratio|107.0|||||TWO_SIDED|90.0|97.8|112.2|||Fieller's method|||||112.2|97.8|
70947896|NCT03616964|141396694|SUPERIORITY||LS Mean difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.84||0.665|TWO_SIDED|95.0|-2.0|1.28|||Mixed Models Analysis|||||1.28|-2.00|0.665
70947897|NCT03616964|141396694|SUPERIORITY||LS Mean difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.84||0.723|TWO_SIDED|95.0|-1.95|1.35|||Mixed Models Analysis|||||1.35|-1.95|0.723
70947898|NCT03616964|141396695|SUPERIORITY||Odds Ratio (OR)|0.69||||0.372|TWO_SIDED|95.0|0.31|1.55|||Regression, Logistic|||||1.55|0.31|0.372
70947899|NCT03616964|141396695|SUPERIORITY||Odds Ratio (OR)|0.78||||0.555|TWO_SIDED|95.0|0.34|1.78|||Regression, Logistic|||||1.78|0.34|0.555
70947900|NCT03616964|141396696|SUPERIORITY||LS Mean difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.422||0.251|TWO_SIDED|95.0|-1.31|0.34|||Mixed Models Analysis|||||0.34|-1.31|0.251
70947901|NCT03616964|141396696|SUPERIORITY||LS Mean difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.425||0.333|TWO_SIDED|95.0|-1.74|-0.07|||Mixed Models Analysis|||||-0.07|-1.74|0.333
71134164|NCT03393494|141770986|EQUIVALENCE|provides 85% power of success|Equivalence ratio|104.0||||0.05|TWO_SIDED|90.0|94.1|108.5|||Fieller's method|||||108.5|94.1|0.05
71134165|NCT01965704|141770987|OTHER|||||||0.2|||||||Fisher Exact|||||||0.2
71134166|NCT01965704|141770988|OTHER||Mean Difference (Final Values)|-1.9||||0.56|TWO_SIDED|95.0|-8.0|4.3|||Wilcoxon Rank-Sum test||The 95% confidence interval between the ondansetron group and the placebo group was calculated with the use of Hodges-Lehmann estimator.|Difference in overall length of stay.||4.3|-8.0|0.56
70861673|NCT00760214|141209866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2|||<|0.001|TWO_SIDED|95.0|-11.46|-4.95||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-4.95|-11.46|<.001
70861674|NCT00760214|141209867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.68|||<|0.001|TWO_SIDED|95.0|-8.19|-3.17||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-3.17|-8.19|<.001
70861675|NCT00760214|141209867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.32|||<|0.001|TWO_SIDED|95.0|-7.81|-2.82||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-2.82|-7.81|<.001
70861676|NCT02545075|141209880|SUPERIORITY|||||||0.5059|||||||Chi-squared|One-sided p-value based on unstratified chi-square test||||||0.5059
70861677|NCT02545075|141209881|SUPERIORITY|||||||0.6202|||||||Chi-squared|One-sided unstratified chi-square||||||0.6202
70861678|NCT02545075|141209882|SUPERIORITY||Stratified cox proportional hazard model|1.13||||0.7267|TWO_SIDED|80.0|0.87|1.45|||Log Rank|One-sided p-value from Log-rank Test stratified by M substage (M1a+M1b vs. M1c)||||1.45|0.87|0.7267
70861679|NCT02545075|141209883|SUPERIORITY||Stratified Cox proportional hazard|0.9||||0.2503|TWO_SIDED|80.0|0.71|1.15|||Log Rank|One-sided p-value from Log-rank Test stratified by M substage (M1a+M1b vs. M1c) and BRAF mutation status as entered into the IVRS||||1.15|0.71|0.2503
70861680|NCT02545075|141209884|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9932|TWO_SIDED|80.0|0.64|1.55|||Cochran-Mantel-Haenszel|||||1.55|0.64|0.9932
70861681|NCT02545075|141209885|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9738|TWO_SIDED|80.0|0.48|2.03|||Cochran-Mantel-Haenszel|||||2.03|0.48|0.9738
70861682|NCT00736879|141209891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.1672|<|0.0001|TWO_SIDED|95.0|-1.02|-0.37||Tested at alpha=0.019 applying Dunnett's adjustment|ANCOVA|||||-0.37|-1.02|<0.0001
70861683|NCT00736879|141209891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.1679|<|0.0001|TWO_SIDED|95.0|-1.07|-0.41|||ANCOVA|Tested at alpha=0.019 applying Dunnett's adjustment.||||-0.41|-1.07|<0.0001
70861684|NCT00736879|141209891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.171|<|0.0001|TWO_SIDED|95.0|-1.17|-0.5|||ANCOVA|Tested at alpha=0.019 applying Dunnett's adjustment.||||-0.50|-1.17|<0.0001
70861685|NCT00736879|141209892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.73|STANDARD_ERROR_OF_MEAN|0.5481||0.0018|TWO_SIDED|95.0|-2.81|-0.65||Test was performed at alpha=0.05.|ANCOVA|||By applying sequential testing procedure, the testing was performed since the primary endpoint was significant.||-0.65|-2.81|0.0018
70861686|NCT00736879|141209892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.68|STANDARD_ERROR_OF_MEAN|0.5474||0.0024|TWO_SIDED|95.0|-2.76|-0.6||Test was performed at alpha=0.05.|ANCOVA|||||-0.60|-2.76|0.0024
70861687|NCT00736879|141209892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.73|STANDARD_ERROR_OF_MEAN|0.5598||0.0022|TWO_SIDED|95.0|-2.83|-0.63||Test was performed at alpha=0.05.|ANCOVA|||||-0.63|-2.83|0.0022
70861688|NCT00736879|141209893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.1|STANDARD_ERROR_OF_MEAN|5.859||0.0103|TWO_SIDED|95.0|-26.7|-3.6||Test was performed at alpha=0.05.|ANCOVA|||||-3.6|-26.7|0.0103
70861689|NCT00736879|141209893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.7|STANDARD_ERROR_OF_MEAN|5.816|<|0.0001|TWO_SIDED|95.0|-37.2|-14.3||Test was performed at alpha=0.05.|ANCOVA|||||-14.3|-37.2|<0.0001
70861690|NCT00736879|141209893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.6|STANDARD_ERROR_OF_MEAN|5.962|<|0.0001|TWO_SIDED|95.0|-44.3|-20.8||Test was performed at alpha=0.05.|ANCOVA|||||-20.8|-44.3|<0.0001
70861691|NCT00736879|141209894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.1|STANDARD_ERROR_OF_MEAN|8.8681|<|0.0001|TWO_SIDED|95.0|-59.56|-24.61||Test was performed at alpha=0.05.|ANCOVA|||||-24.61|-59.56|<0.0001
70861692|NCT00736879|141209894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-48.1|STANDARD_ERROR_OF_MEAN|9.1963|<|0.0001|TWO_SIDED|95.0|-66.27|-30.03||Test was performed at alpha=0.05.|ANCOVA|||||-30.03|-66.27|<0.0001
70861693|NCT00736879|141209894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-60.6|STANDARD_ERROR_OF_MEAN|9.1796|<|0.0001|TWO_SIDED|95.0|-78.67|-42.5||Test was performed at alpha=0.05.|ANCOVA|||||-42.50|-78.67|<0.0001
70861694|NCT00736879|141209895|SUPERIORITY_OR_OTHER||percent difference|18.9|STANDARD_ERROR_OF_MEAN|7.38||0.0157|TWO_SIDED|95.0|3.6|34.3||Test was performed at alpha=0.05.|Regression, Logistic|Logistic regression based on the methodology of Zhang, Tsiatis and Davidian and Tsiatis, Davidian, Zhang and Lu, with adjustment for baseline HbA1c.||The probability of response was modeled using a logistic regression model with baseline HbA1c as the covariate. Treatment group estimates of response rate were then obtained by integrating each group's modeled probability of response over the observed distribution of baseline covariate (combined across groups).||34.3|3.6|0.0157
70861695|NCT00736879|141209895|SUPERIORITY_OR_OTHER||Percent Difference|8.8|STANDARD_ERROR_OF_MEAN|7.65||0.2512|TWO_SIDED|95.0|-6.2|23.8||Test was performed at alpha=0.05.|Regression, Logistic|Logistic regression based on the methodology of Zhang, Tsiatis and Davidian and Tsiatis, Davidian, Zhang and Lu, with adjustment for baseline HbA1c||The probability of response was modeled using a logistic regression model with baseline HbA1c as the covariate. Treatment group estimates of response rate were then obtained by integrating each group's modeled probability of response over the observed distribution of baseline covariate (combined across groups).||23.8|-6.2|0.2512
70861696|NCT00736879|141209895|SUPERIORITY_OR_OTHER||Percent Difference|14.5|STANDARD_ERROR_OF_MEAN|8.069||0.0726|TWO_SIDED|95.0|-1.3|30.3||Test was performed at alpha=0.05.|Regression, Logistic|Logistic regression based on the methodology of Zhang, Tsiatis and Davidian and Tsiatis, Davidian, Zhang and Lu, with adjustment for baseline HbA1c||The probability of response was modeled using a logistic regression model with baseline HbA1c as the covariate. Treatment group estimates of response rate were then obtained by integrating each group's modeled probability of response over the observed distribution of baseline covariate (combined across groups).||30.3|-1.3|0.0726
70861697|NCT00736879|141209896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.7954||0.3163|TWO_SIDED|95.0|-2.37|0.77||Test was performed at alpha=0.05.|ANCOVA|||||0.77|-2.37|0.3163
70872142|NCT03808493|141229522|EQUIVALENCE|For log-transformed (natural log) MRT∞,ev, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.0306|||||TWO_SIDED|90.0|-0.0003|0.0616||||||||0.0616|-0.0003|
71134167|NCT01965704|141770988|OTHER||Median Difference (Final Values)|-1.9||||0.07|TWO_SIDED|95.0|-4.0|0.2|||Wilcoxon Rank-Sum test||The 95% confidence interval between the ondansetron group and the placebo group was calculated with the use of Hodges-Lehmann estimator.|Difference in length of stay as calculated with maximum length capped at 15 days.||0.2|-4.0|0.07
71134168|NCT01965704|141770989|OTHER||Mean Difference (Final Values)|-1.8||||0.31|TWO_SIDED|95.0|-8.8|2.7|||Wilcoxon Rank-Sum test||The 95% confidence interval between the ondansetron group and the placebo group was calculated with the use of Hodges-Lehmann estimator.|||2.7|-8.8|0.31
70861698|NCT00736879|141209896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.8154|||TWO_SIDED|95.0|-2.22|0.99|||ANCOVA|||Following a sequential testing procedure, this comparison was not statistically tested, ie, the previous comparison did not meet the criterion for statistical significance.||0.99|-2.22|
70861699|NCT00736879|141209896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|0.8238|||TWO_SIDED|95.0|-3.09|0.16|||ANCOVA|||Following a sequential testing procedure, this comparison was not statistically tested, ie, the previous comparison did not meet the criterion for statistical significance.||0.16|-3.09|
70861700|NCT02325791|141209969|SUPERIORITY||percentage treatment difference|1.15||||0.5773|TWO_SIDED|95.0|-2.898|5.201|||Cochran-Mantel-Haenszel|||A hierarchical inferential approach was used to control Type-1 error at 0.05 for pairwise comparisons of each suptavumab dose regimen to placebo. Missing values were imputed to KM estimate from the placebo group. Randomization strata adjusted in CMH test include region (North America vs. Rest of World) \& gestational age category (\<= 31 weeks 6 days GA vs \>= 32 weeks 0 days and \<= 35 weeks 6 days GA). Threshold for significance at 0.05 level.||5.201|-2.898|0.5773
70861701|NCT02325791|141209969|SUPERIORITY||percentage treatment difference|-0.44|||||TWO_SIDED|95.0|-4.318|3.438||Analysis performed using CMH statistics with randomization stratum adjusted using Mantel-Haenzel (MH) method to assess pairwise treatment difference (i.e. absolute risk reduction of each suptavumab arm compared to placebo.|Cochran-Mantel-Haenszel|||A hierarchical inferential approach was used to control Type-1 error at 0.05 for pairwise comparisons of each Suptavumab dose regimen to placebo. Missing values were imputed to Kaplan-Meier (KM) estimate from the placebo group. Randomization strata adjusted in Cochran-Mantel-Haenszel (CMH) test include region (North America vs. Rest of World) \& gestational age category (\<= 31 weeks 6 days GA vs \>= 32 weeks 0 days and \<= 35 weeks 6 days GA). Threshold for significance at 0.05 level.||3.438|-4.318|
70861702|NCT02325791|141209973|SUPERIORITY||percentage treatment difference|-0.67|||||TWO_SIDED|95.0|-5.291|3.959|||Cochran-Mantel-Haenszel|||A hierarchical inferential approach was used to control Type-1 error at 0.05 for pairwise comparisons of each suptavumab dose regimen to placebo. Missing values were imputed to KM estimate from the placebo group. Randomization strata adjusted in CMH test include region (North America vs. Rest of World) \& gestational age category (\<= 31 weeks 6 days GA vs \>= 32 weeks 0 days and \<= 35 weeks 6 days GA). Threshold for significance at 0.05 level.||3.959|-5.291|
70861703|NCT02325791|141209973|SUPERIORITY||percentage treatment difference|2.02|||||TWO_SIDED|95.0|-2.836|6.867|||Cochran-Mantel-Haenszel|||A hierarchical inferential approach was used to control Type-1 error at 0.05 for pairwise comparisons of each suptavumab dose regimen to placebo. Missing values were imputed to KM estimate from the placebo group. Randomization strata adjusted in CMH test include region (North America vs. Rest of World) \& gestational age category (\<= 31 weeks 6 days GA vs \>= 32 weeks 0 days and \<= 35 weeks 6 days GA). Threshold for significance at 0.05 level.||6.867|-2.836|
70861704|NCT04795622|141210025|SUPERIORITY||Odds Ratio (OR)|1.3545|||||TWO_SIDED|95.0|0.753|2.4365||||||||2.4365|0.7530|
70861705|NCT04795622|141210026|SUPERIORITY||Point Estimate|-0.0856|||||TWO_SIDED|95.0|-0.2395|0.0683||||||X-axis||0.0683|-0.2395|
70861706|NCT04795622|141210026|SUPERIORITY||Point Estimate|-0.033|||||TWO_SIDED|95.0|-0.2268|0.1608||||||Y-axis||0.1608|-0.2268|
70861707|NCT04795622|141210026|SUPERIORITY||Point Estimate|0.1791|||||TWO_SIDED|95.0|-0.1551|0.5133||||||Z-axis||0.5133|-0.1551|
70861708|NCT00089674|141210031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|||<|0.0001||95.0|6.2|7.1|||ANCOVA|||||7.1|6.2|<0.0001
70861709|NCT00089674|141210032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|||<|0.0001||95.0|3.5|4.4||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|ANCOVA|||||4.4|3.5|<0.0001
70861710|NCT00089674|141210033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8|||<|0.0001||95.0|4.4|5.1||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|ANCOVA|||||5.1|4.4|<0.0001
70861711|NCT00089674|141210034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9|||<|0.0001||95.0|7.4|8.4||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|ANCOVA|||||8.4|7.4|<0.0001
70861712|NCT00089674|141210035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9|||<|0.0001||95.0|4.4|5.4||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|ANCOVA|||||5.4|4.4|<0.0001
70861713|NCT00089674|141210036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.7|||<|0.0001||95.0|5.4|6.1||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|ANCOVA|||||6.1|5.4|<0.0001
70861714|NCT00089674|141210037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.1048||95.0|0.46|1.08||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|Regression, Logistic|||||1.08|0.46|0.1048
70861715|NCT00089674|141210038|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.37||||0.0125||95.0|0.18|0.78||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|Regression, Logistic|||||0.78|0.18|0.0125
70861716|NCT00089674|141210039|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.7961||95.0|0.57|1.55||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|Regression, Cox|||||1.55|0.57|0.7961
70861717|NCT00089674|141210040|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.7961||95.0|0.44|1.11||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|Regression, Logistic|||||1.11|0.44|0.7961
70861718|NCT02961218|141210041|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_DEVIATION|0.57||0.55|TWO_SIDED|90.0|-1.03|0.85||probability reduction of average pain score in ACZ885 \> Placebo|Bayesian model for repeated measures||Lower limit and upper limit represents the credibility interval from the Bayesian analysis.|||0.85|-1.03|0.55
70861719|NCT02961218|141210043|SUPERIORITY||Ratio|0.408||||0.002|TWO_SIDED|90.0|0.253|0.658|||Mixed-effect Model for Repeated Measures|||||0.658|0.253|0.002
70861720|NCT02961218|141210044|SUPERIORITY||Ratio|0.752|||<|0.001|TWO_SIDED|90.0|0.657|0.862|||Mixed-effect Model for Repeated Measures|||||0.862|0.657|<.001
70861721|NCT02961218|141210045|SUPERIORITY||Ratio|0.682||||0.004|TWO_SIDED|90.0|0.547|0.849|||Mixed-effect Model for Repeated Measures|||||0.849|0.547|0.004
70861722|NCT02961218|141210046|SUPERIORITY||Ratio|0.718||||0.032|TWO_SIDED|90.0|0.556|0.925|||Mixed-effect Model for Repeated Measures|||||0.925|0.556|0.032
70861723|NCT02961218|141210053|SUPERIORITY||Ratio|1.4|STANDARD_ERROR_OF_MEAN|0.45||0.455|TWO_SIDED|90.0|0.58|3.4|||Generalized Linear Model (GLM)|||||3.40|0.58|0.455
71134169|NCT01526213|141770991|SUPERIORITY_OR_OTHER||Geometric Mean AUC Ratio (GFJ/mGFJ)|0.96||||0.78|TWO_SIDED|90.0|0.4|1.5|||t-test, 2 sided|||For juice comparisons, fexofenadine + furanocoumarin-free grapefruit juice will be the test agent (numerator) and fexofenadine + grapefruit juice will be the reference standard (denominator).||1.5|0.4|0.78
71134170|NCT00413218|141771014|NON_INFERIORITY|The lower bound of the 95% CI for the adjusted treatment difference was compared to the protocol prespecified noninferiority margin (NIM) value of -15%. If the lower bound were greater than -15%, isavuconazole would be declared as noninferior to caspofungin.|Adjusted Treatment Difference (%)|-10.8|||||TWO_SIDED|95.0|-19.9|-1.8|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|The adjusted treatment difference (ISA-CAS) was calculated by a stratified Cochran-Mantel-Haenszel (CMH) method with the strata of geographical region and baseline neutropenic status.||-1.8|-19.9|
71134171|NCT00413218|141771015|OTHER||Adjusted Treatment Difference (%)|-2.7|||||TWO_SIDED|95.0|-12.2|6.8|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||6.8|-12.2|
71134172|NCT00413218|141771016|OTHER||Adjusted Treatment Difference %|-10.9|||||TWO_SIDED|95.0|-19.9|-1.9|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-1.9|-19.9|
71134173|NCT00413218|141771016|OTHER||Adjusted Treatment Difference %|-5.4|||||TWO_SIDED|95.0|-15.0|4.2|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at FU2 (6 weeks after end of treatment). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||4.2|-15.00|
71134174|NCT00413218|141771017|OTHER||Adjusted Treatment Difference (%)|-8.2|||||TWO_SIDED|95.0|-15.4|-0.9|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOIV (Days 11-56).The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-0.9|-15.4|
71134175|NCT00413218|141771017|OTHER||Adjusted Treatment Difference (%)|-8.6|||||TWO_SIDED|95.0|-15.8|-1.5|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-1.5|-15.8|
71134176|NCT00413218|141771017|OTHER||Adjusted Treatment Difference (%)|-0.4|||||TWO_SIDED|95.0|-9.1|8.3|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at FU1 (2 weeks after end of treatment). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||8.3|-9.1|
71134177|NCT00413218|141771017|OTHER||Adjusted Treatment Difference (%)|-5.8|||||TWO_SIDED|95.0|-15.3|3.6|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at FU2 (6 weeks after end of treatment).The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||3.6|-15.3|
71134178|NCT00413218|141771018|OTHER||Adjusted Treatment Difference (%)|-14.9|||||TWO_SIDED|95.0|-22.7|-7.0|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOIV (Days 11-56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-7.0|-22.7|
71134179|NCT00413218|141771018|OTHER||Adjusted Treatment Difference (%)|-15.9|||||TWO_SIDED|95.0|-23.5|-8.4|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-8.4|-23.5|
71134180|NCT00413218|141771018|OTHER||Adjusted Treatment Difference (%)|-0.7|||||TWO_SIDED|95.0|-8.1|9.6|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at FU1 (2 weeks after end of treatment).The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||9.6|-8.1|
71134181|NCT00413218|141771018|OTHER||Adjusted Treatment Difference (%)|-5.2|||||TWO_SIDED|95.0|-14.7|4.3|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at FU2 (6 weeks after end of treatment).The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||4.3|-14.7|
71134182|NCT00413218|141771019|OTHER||Adjusted Treatment Difference (%)|-11.4|||||TWO_SIDED|95.0|-20.4|-2.5|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at Day 7. The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-2.5|-20.4|
71134183|NCT00413218|141771019|OTHER||Adjusted Treatment Difference (%)|-8.5|||||TWO_SIDED|95.0|-16.5|-0.4|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-0.4|-16.5|
71134184|NCT00413218|141771020|OTHER||Adjusted Treatment Difference (%)|-11.1|||||TWO_SIDED|95.0|-20.3|-1.9|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at Day 7. The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-1.9|-20.3|
71134185|NCT00413218|141771020|OTHER||Adjusted Treatment Difference (%)|-8.1|||||TWO_SIDED|95.0|-16.3|0.1|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||0.1|-16.3|
71134186|NCT00413218|141771021|OTHER||Adjusted Treatment Difference (%)|2.5|||||TWO_SIDED|95.0|-3.8|8.9||||||Statistical analysis of all-cause mortality on Day 14. Adjusted treatment difference (Isavuconazole-Caspofungin) is calculated by a stratified CMH method with the strata of geographical regions, and baseline neutropenic status.||8.9|-3.8|
71134187|NCT00413218|141771021|OTHER||Adjusted Treatment Difference (%)|1.4|||||TWO_SIDED|95.0|-7.1|10.0||||||Statistical analysis of all-cause mortality on Day 56. Adjusted treatment difference (Isavuconazole-Caspofungin) is calculated by a stratified CMH method with the strata of geographical regions, and baseline neutropenic status.||10.0|-7.1|
71134188|NCT01687296|141771055|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated at the lower limit of the 95% confidence interval (5%, 2-sided significance level) for the treatment difference (FP minus prednisone) in the mean morning PEF on diary card over the treatment assessment period was greater than -12L/min.|Mean Difference (Final Values)|0.46||||0.931|TWO_SIDED|95.0|-9.85|10.76|||ANCOVA|||250 par were to be enrolled to achieve 200 total evaluable par or 100 evaluable par per group. Sample size was based on the primary efficacy endpoint (AM PEF) and had 80% power to reject the null hypothesis: nebulized FP (1 mg BID) was inferior to oral prednisone with regard to AM PEF using one-side t test at significance level 2.5%, and assuming true treatment difference (FP minus predisone) was 3.6 L/min, noninferiority margin was -12L/min, and common standard deviation was 39 L/min.||10.76|-9.85|0.931
71134189|NCT01687296|141771056|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated at the lower limit of the 95% confidence interval (5%, 2-sided significance level) for the treatment difference (FP minus prednisone) in the mean morning PEF on diary card over the treatment assessment period was greater than -12L/min.|Mean Difference (Final Values)|0.5||||0.922|TWO_SIDED|95.0|-9.64|10.65|||ANCOVA|||||10.65|-9.64|0.922
71134190|NCT01687296|141771057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.16||||0.822|TWO_SIDED|95.0|-9.02|11.34|||ANCOVA|||||11.34|-9.02|0.822
71134191|NCT01687296|141771058|SUPERIORITY_OR_OTHER|||||||0.717||95.0|||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for day-time symptom score||||0.717
71134192|NCT01687296|141771058|SUPERIORITY_OR_OTHER|||||||0.683||95.0|||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for night-time symptom score||||0.683
71134193|NCT01687296|141771059|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||Wilcoxon rank sum test|||||||0.996
71134194|NCT01687296|141771060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044||||0.348|TWO_SIDED|95.0|-0.135|0.048|||ANCOVA|||Fluticasone propionate versus Prednisone for FEV1 on Day 5||0.048|-0.135|0.348
71134195|NCT01687296|141771060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004||||0.914|TWO_SIDED|95.0|-0.074|0.083|||ANCOVA|||Fluticasone propionate versus Prednisone for FEV1 on Day 8||0.083|-0.074|0.914
71134196|NCT01687296|141771060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.067||||0.276|TWO_SIDED|95.0|-0.187|0.054|||ANCOVA|||Fluticasone propionate versus Prednisone for FVC on Day 5||0.054|-0.187|0.276
71134197|NCT01687296|141771060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039||||0.384|TWO_SIDED|95.0|-0.126|0.049|||ANCOVA|||Fluticasone propionate versus Prednisone for FVC on Day 8||0.049|-0.126|0.384
71134198|NCT01687296|141771061|SUPERIORITY_OR_OTHER|||||||0.507||95.0|||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for clinical scoring index on Day 5||||0.507
71134199|NCT01687296|141771061|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for clinical scoring index on Day 8||||0.700
71134200|NCT01687296|141771062|SUPERIORITY_OR_OTHER|||||||0.633||95.0|||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for participant/parent global evaluation||||0.633
71134201|NCT01687296|141771062|SUPERIORITY_OR_OTHER|||||||0.323||95.0|||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for investigator global evaluation||||0.323
71134202|NCT00799903|141771079|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.199|TWO_SIDED|95.1|0.85|1.03||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.03|0.85|0.199
71134203|NCT00799903|141771080|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.045|TWO_SIDED|95.0|0.82|1.0||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.00|0.82|0.045
70947902|NCT03616964|141396697|SUPERIORITY||LS Mean difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.282||0.284|TWO_SIDED|95.0|-0.86|0.25|||Mixed Models Analysis|||||0.25|-0.86|0.284
70947903|NCT03616964|141396697|SUPERIORITY||LS Mean difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.284||0.069|TWO_SIDED|95.0|-1.08|0.04|||Mixed Models Analysis|||||0.04|-1.08|0.069
71134204|NCT00799903|141771081|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.019|TWO_SIDED|95.0|0.84|0.98||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||0.98|0.84|0.019
71134205|NCT00799903|141771082|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.594|TWO_SIDED|95.0|0.83|1.11||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.11|0.83|0.594
71134206|NCT00799903|141771083|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.108|TWO_SIDED|95.0|0.77|1.03||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.03|0.77|0.108
71134207|NCT00799903|141771084|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.92|TWO_SIDED|95.0|0.81|1.27||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.27|0.81|0.920
71134208|NCT00799903|141771085|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.397|TWO_SIDED|95.0|0.88|1.05||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.05|0.88|0.397
71134209|NCT00799903|141771086|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.87|TWO_SIDED|95.0|0.9|1.13||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.13|0.90|0.870
71134210|NCT02518971|141771087|OTHER|||||||0.345|||||||Chi-squared|||||||0.345
71134211|NCT02518971|141771088|OTHER|||||||0.378|||||||Student T-Test|||||||.378
71134212|NCT02518971|141771089|OTHER|||||||1|||||||Fisher Exact|||||||1.0
71134213|NCT02518971|141771090|OTHER|||||||0.497|||||||Fisher Exact|||||||.497
71134214|NCT02518971|141771091|OTHER|||||||0.207|||||||Student T-test|||||||.207
71134215|NCT02336230|141771093|OTHER|||||||0.0003||||||P-value was calculated from the binomial distribution under the assumption of a 0.45 success rate for the null hypothesis.|Binomial Distribution|||||||0.0003
71134216|NCT02336230|141771095|OTHER|||||||0.0032||||||P-value was from a Cochran-Mantel-Haenszel (CMH) test stratified by baseline aGVHD grade.|CHM test|||||||0.0032
71134217|NCT02524171|141771099|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|-0.1|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
71134218|NCT02524171|141771099|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|-0.88|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
71134219|NCT02524171|141771100|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.06|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
71134220|NCT02524171|141771100|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.02|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
71134221|NCT02524171|141771101|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|10.98|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
71134222|NCT02524171|141771101|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|14.64|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
71134223|NCT02524171|141771102|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|1.45|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews||||||>0.05
71134224|NCT02524171|141771102|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|1.22|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
71134225|NCT02524171|141771103|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.04|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
71134226|NCT02524171|141771103|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.02|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63).||||>0.05
71134227|NCT02524171|141771104|SUPERIORITY||Time x Condition at 6mo.(Beta value)|0.04|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
71134228|NCT02524171|141771104|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.02|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
71134229|NCT02524171|141771105|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.02|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
71134230|NCT02524171|141771105|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|-0.08|||<|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||<0.05
71134231|NCT02524171|141771106|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.06|||<|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||<0.05
71134232|NCT02524171|141771106|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.06|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
71134233|NCT02524171|141771107|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta|0.69|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
71134234|NCT02524171|141771107|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|-0.89|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
71134235|NCT02524171|141771108|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|0.07|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
71134236|NCT02524171|141771108|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|0.01|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
71134237|NCT02524171|141771109|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|6.53|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
71134238|NCT02524171|141771109|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|5.68|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63||||>0.05
71134239|NCT02524171|141771110|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|0.83|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
71134240|NCT02524171|141771110|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|0.46|||<|0.01|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63).||||<0.01
71134241|NCT02524171|141771111|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)|0.02|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
70861724|NCT00591266|141210056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.19|||<|0.001|TWO_SIDED|95.0|-13.29|-9.09||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-9.09|-13.29|<0.001
70861725|NCT00591266|141210056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.91|||<|0.001|TWO_SIDED|95.0|-13.0|-8.81||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-8.81|-13.00|<0.001
70861726|NCT00591266|141210057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.02|||<|0.001|TWO_SIDED|95.0|-13.93|-8.1||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-8.10|-13.93|<0.001
70861727|NCT00591266|141210057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.56|||<|0.001|TWO_SIDED|95.0|-12.48|-6.63||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-6.63|-12.48|<0.001
70861728|NCT00591266|141210058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.48|||<|0.001|TWO_SIDED|95.0|-8.84|-6.11||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.11|-8.84|<0.001
70861729|NCT00591266|141210058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.65|||<|0.001|TWO_SIDED|95.0|-9.01|-6.28||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.28|-9.01|<0.001
70861730|NCT00591266|141210059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.93|||<|0.001|TWO_SIDED|95.0|-6.62|-3.23||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.23|-6.62|<0.001
70861731|NCT00591266|141210059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.58|||<|0.001|TWO_SIDED|95.0|-7.28|-3.88||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.88|-7.28|<0.001
71134242|NCT02524171|141771111|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)|-0.08|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63).||||>0.05
70861732|NCT00591266|141210060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.64|||<|0.001|TWO_SIDED|95.0|-13.86|-9.41||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.41|-13.86|<0.001
70861733|NCT00591266|141210060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.17|||<|0.001|TWO_SIDED|95.0|-13.39|-8.95||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.95|-13.39|<0.001
70861734|NCT00591266|141210061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.99|||<|0.001|TWO_SIDED|95.0|-9.47|-6.5||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.50|-9.47|<0.001
70861735|NCT00591266|141210061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.04|||<|0.001|TWO_SIDED|95.0|-9.52|-6.55||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.55|-9.52|<0.001
70861736|NCT00591266|141210062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.7|||<|0.001|TWO_SIDED|95.0|-12.07|-7.34||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.34|-12.07|<0.001
70861737|NCT00591266|141210062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.67|||<|0.001|TWO_SIDED|95.0|-12.03|-7.31||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.31|-12.03|<0.001
70861738|NCT00591266|141210063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.26|||<|0.001|TWO_SIDED|95.0|-7.94|-4.57||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.57|-7.94|<0.001
70861739|NCT00591266|141210063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.28|||<|0.001|TWO_SIDED|95.0|-7.96|-4.6||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.60|-7.96|<0.001
71134243|NCT02524171|141771112|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)]|-0.03|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
70861740|NCT00591266|141210064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.27|||<|0.001|TWO_SIDED|95.0|-14.63|-9.92||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.92|-14.63|<0.001
70861741|NCT00591266|141210064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.58|||<|0.001|TWO_SIDED|95.0|-13.93|-9.23||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.23|-13.93|<0.001
70861742|NCT00591266|141210065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.39|||<|0.001|TWO_SIDED|95.0|-9.98|-6.79||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.79|-9.98|<0.001
70861743|NCT00591266|141210065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.23|||<|0.001|TWO_SIDED|95.0|-9.82|-6.64||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.64|-9.82|<0.001
70861744|NCT00591266|141210066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.83|||<|0.001|TWO_SIDED|95.0|-11.45|-6.22||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.22|-11.45|<0.001
70861745|NCT00591266|141210066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.91|||<|0.001|TWO_SIDED|95.0|-11.51|-6.3||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.30|-11.51|<0.001
70861746|NCT00591266|141210067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.94|||<|0.001|TWO_SIDED|95.0|-7.88|-4.0||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.00|-7.88|<0.001
70861747|NCT00591266|141210067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.54|||<|0.001|TWO_SIDED|95.0|-8.47|-4.61||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.61|-8.47|<0.001
70861748|NCT00591266|141210068|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.37|||<|0.001|TWO_SIDED|95.0|2.15|5.26||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||5.26|2.15|<0.001
70861749|NCT00591266|141210068|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.21|||<|0.001|TWO_SIDED|95.0|2.05|5.03||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||5.03|2.05|<0.001
70861750|NCT00591266|141210069|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.54|||<|0.001|TWO_SIDED|95.0|2.08|6.02||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||6.02|2.08|<0.001
70861751|NCT00591266|141210069|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.9|||<|0.001|TWO_SIDED|95.0|2.25|6.75||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||6.75|2.25|<0.001
70861752|NCT00591266|141210070|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.62|||<|0.001|TWO_SIDED|95.0|1.71|4.02||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||4.02|1.71|<0.001
70861753|NCT00591266|141210070|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.12|||<|0.001|TWO_SIDED|95.0|2.01|4.82||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||4.82|2.01|<0.001
71134244|NCT02524171|141771112|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)]|-0.07|||<|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63).||||<0.05
70861754|NCT01178073|141210093|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.502||||0.0002|TWO_SIDED|95.0|0.348|0.724|||Stratified Log Rank||Analysis of time to first adjudicated clinical failure event through FAV. HR is calculated using the Cox proportional hazards model. HR is for Combination Therapy: Ambrisentan + Tadalafil / Monotherapy Pooled: Ambrisentan or Tadalafil.|||0.724|0.348|0.0002
70861755|NCT01178073|141210093|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.477||||0.0004|TWO_SIDED|95.0|0.314|0.723|||Stratified Log Rank||Analysis of time to first adjudicated clinical failure event through FAV. HR is calculated using the Cox proportional hazards model. HR is for Combination Therapy: Ambrisentan + Tadalafil / Ambrisentan Monotherapy.|||0.723|0.314|0.0004
70861756|NCT01178073|141210093|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.528||||0.0045|TWO_SIDED|95.0|0.338|0.827|||Stratified Log Rank||Analysis of time to first adjudicated clinical failure event through FAV. HR is calculated using the Cox proportional hazards model. HR is for Combination Therapy: Ambrisentan + Tadalafil / Tadalafil Monotherapy.|||0.827|0.338|0.0045
70861757|NCT01178073|141210094|SUPERIORITY_OR_OTHER||Mean Percent Difference|-33.81|||<|0.0001|TWO_SIDED|95.0|-44.78|-20.66|||ANCOVA||Mean percent difference is for Combination Therapy: Ambrisentan + Tadalafil - Monotherapy Pooled: Ambrisentan or Tadalafil.|||-20.66|-44.78|<0.0001
70861758|NCT01178073|141210094|SUPERIORITY_OR_OTHER||Mean Percent Difference|-25.09||||0.0111|TWO_SIDED|95.0|-40.04|-6.4|||ANCOVA||Mean percent difference is for Combination Therapy: Ambrisentan + Tadalafil - Ambrisentan Monotherapy.|||-6.40|-40.04|0.0111
70861759|NCT01178073|141210094|SUPERIORITY_OR_OTHER||Mean Percent Difference|-41.51|||<|0.0001|TWO_SIDED|95.0|-53.16|-26.97|||ANCOVA||Mean percent difference is for Combination Therapy: Ambrisentan + Tadalafil - Tadalafil Monotherapy.|||-26.97|-53.16|<0.0001
71134245|NCT02524171|141771113|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)]|0.01|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
71134246|NCT02524171|141771113|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)]|-0.08|||<|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63).||||<0.05
70861760|NCT01178073|141210095|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.563||||0.0264|TWO_SIDED|95.0|1.054|2.319|||Regression, Logistic||Odds ratio is for Combination Therapy: Ambrisentan + Tadalafil / Monotherapy Pooled: Ambrisentan or Tadalafil.|||2.319|1.054|0.0264
70861761|NCT01178073|141210095|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.424||||0.1518|TWO_SIDED|95.0|0.878|2.308|||Regression, Logistic||Odds ratio is for Combination Therapy: Ambrisentan + Tadalafil / Ambrisentan Monotherapy.|||2.308|0.878|0.1518
70861762|NCT01178073|141210095|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.723||||0.0321|TWO_SIDED|95.0|1.047|2.833|||Regression, Logistic||Odds ratio is for Combination Therapy: Ambrisentan + Tadalafil / Tadalafil Monotherapy.|||2.833|1.047|0.0321
70861763|NCT01178073|141210096|SUPERIORITY_OR_OTHER||Median Difference|22.75|||<|0.0001|TWO_SIDED|95.0|12.0|33.5|||Stratified Wilcoxon Rank Sum Test||Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Monotherapy Pooled: Ambrisentan or Tadalafil.|||33.50|12.00|<0.0001
70861764|NCT01178073|141210096|SUPERIORITY_OR_OTHER||Median Difference|24.75||||0.0005|TWO_SIDED|95.0|11.0|38.5|||Stratified Wilcoxon Rank Sum Test||Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Ambrisentan Monotherapy.|||38.50|11.00|0.0005
70861765|NCT01178073|141210096|SUPERIORITY_OR_OTHER||Median Difference|20.85||||0.003|TWO_SIDED|95.0|8.0|33.7|||Stratified Wilcoxon Rank Sum Test||Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Tadalafil Monotherapy.|||33.70|8.00|0.0030
70861766|NCT01178073|141210097|SUPERIORITY_OR_OTHER||Median Difference|0.0||||0.2287|TWO_SIDED|95.0|0.0|0.0|||Stratified Wilcoxon Rank Sum Test||Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Monotherapy Pooled: Ambrisentan or Tadalafil.|||0.0|0.0|0.2287
70861767|NCT01178073|141210097|SUPERIORITY_OR_OTHER||Median Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||Stratified Wilcoxon Rank Sum Test|This comparison was not formally tested according to the pre-defined hierarchical testing procedure.|Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Ambrisentan Monotherapy.|||0.0|0.0|
70861768|NCT01178073|141210097|SUPERIORITY_OR_OTHER||Median Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||Stratified Wilcoxon Rank Sum Test|This comparison was not formally tested according to the pre-defined hierarchical testing procedure.|Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Tadalafil Monotherapy.|||0.0|0.0|
70861769|NCT01178073|141210098|SUPERIORITY_OR_OTHER||Median Difference|-0.38|||||TWO_SIDED|95.0|-0.75|0.0|||Stratified Wilcoxon Rank Sum Test|This endpoint was not formally tested according to the pre-defined hierarchical testing procedure.|Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Monotherapy Pooled: Ambrisentan or Tadalafil.|||0.00|-0.75|
70861770|NCT01178073|141210098|SUPERIORITY_OR_OTHER||Median Difference|-0.5|||||TWO_SIDED|95.0|-1.0|0.0|||Stratified Wilcoxon Rank Sum Test|This endpoint was not formally tested according to the pre-defined hierarchical testing procedure.|Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Ambrisentan Monotherapy.|||0.00|-1.00|
70861771|NCT01178073|141210098|SUPERIORITY_OR_OTHER||Median Difference|-0.5|||||TWO_SIDED|95.0|-1.0|0.0|||Stratified Wilcoxon Rank Sum Test|This endpoint was not formally tested according to the pre-defined hierarchical testing procedure.|Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Tadalafil Monotherapy.|||0.00|-1.00|
70861772|NCT01352468|141210099|SUPERIORITY_OR_OTHER|||||||0.35|||||||ANCOVA|Controlling for baseline scores||||||.35
70861773|NCT01352468|141210100|SUPERIORITY_OR_OTHER|||||||0.68|||||||ANCOVA|Controlling for baseline scores||||||.68
70861774|NCT01352468|141210101|SUPERIORITY_OR_OTHER|||||||0.57|||||||ANCOVA|Controlling for baseline scores||||||.57
70861775|NCT03496571|141210147|SUPERIORITY||LSM Difference from Placebo|-95.0|||<|0.001|TWO_SIDED|95.0|-122.0|-68.0|||ANCOVA|||||-68|-122|<0.001
70861776|NCT03496571|141210147|SUPERIORITY||LSM Difference from Placebo|-102.0|||<|0.001|TWO_SIDED|95.0|-128.0|-76.0|||ANCOVA|||||-76|-128|<0.001
70861777|NCT03496571|141210147|SUPERIORITY||LSM Difference from Placebo|-98.0|||<|0.001|TWO_SIDED|95.0|-121.0|-76.0|||ANCOVA|||||-76|-121|<0.001
70861778|NCT03496571|141210148|SUPERIORITY||Percent Difference from Placebo|55.0|||<|0.001|TWO_SIDED|95.0|27.0|76.0|||Fisher Exact|||||76|27|<0.001
70861779|NCT03496571|141210148|SUPERIORITY||Percent Difference from Placebo|62.0|||<|0.001|TWO_SIDED|95.0|34.0|82.0|||Fisher Exact|||||82|34|<0.001
70861780|NCT03496571|141210148|SUPERIORITY||Percent Difference from Placebo|58.0|||<|0.001|TWO_SIDED|95.0|36.0|74.0|||Fisher Exact|||||74|36|<0.001
70861781|NCT03496571|141210149|SUPERIORITY||LSM Difference from Placebo|-20.0||||0.05|TWO_SIDED|95.0|-40.0|0.0|||ANCOVA|||||0|-40|0.05
70861782|NCT03496571|141210149|SUPERIORITY||LSM Difference from Placebo|-33.0||||0.002|TWO_SIDED|95.0|-53.0|-13.0|||ANCOVA|||||-13|-53|0.002
70861783|NCT03496571|141210149|SUPERIORITY||LSM Difference from Placebo|-26.0||||0.004|TWO_SIDED|95.0|-44.0|-9.0|||ANCOVA|||||-9|-44|0.004
70861784|NCT01226043|141210164|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.3|||<|0.0001|TWO_SIDED|95.0|2.15|2.44|||ANOVA|The last observation carried forward (LOCF) method was applied to impute missing Week 4 overall patient preference values for ANOVA analysis.||The hypothesis was to determine whether patients have higher preference score for Lantus® SoloSTAR® pen compared to Lantus® vial/syringe. Differences of patient preference score greater than 0.5 were considered clinically meaningful. The power for detecting a true difference of 0.5 considering a standard deviation from 1.6 to 2.5, assuming 130 evaluable patients per arm and a two-sided test at 0.05 significance level ranged from 89% to more than 99%.||2.44|2.15|<0.0001
70861785|NCT00191646|141210213|SUPERIORITY_OR_OTHER|||||||0.199||95.0|||||Log Rank|||Using a two-sided log-rank test with a Type I error of 0.05, 636 events for PFS out of the 919 patients would give an 80% statistical power under the alternative hypothesis that the hazard ratio of the G/C arm versus the P/C arm was 0.08.||||0.199
70861786|NCT00191646|141210214|SUPERIORITY_OR_OTHER|||||||0.771||95.0|||||Fisher Exact|||||||0.771
70861787|NCT00191646|141210214|SUPERIORITY_OR_OTHER|||||||0.784||95.0|||||Fisher Exact|||||||0.784
70861788|NCT00191646|141210215|SUPERIORITY_OR_OTHER|||||||0.621||95.0|||||Log Rank|||||||0.621
70861789|NCT00191646|141210216|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||Log Rank|||||||0.013
70861790|NCT02103218|141210254|SUPERIORITY|||||||0.62|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.62
70861791|NCT02103218|141210255|SUPERIORITY|||||||0.15|||||||logistic GEE|||Results from logistic GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares predicted probabilities converted to %, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.15
70872143|NCT03808493|141229523|EQUIVALENCE|For log-transformed (natural log) λz, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.0209|||||TWO_SIDED|90.0|-0.0112|0.053||||||||0.0530|-0.0112|
70947904|NCT00656201|141396700|NON_INFERIORITY_OR_EQUIVALENCE|This was an equivalence comparison. The study was designed to detect a 14% pregnancy difference between the arms with 80% power and one interim analysis using O'Brien-Fleming parameters and an experiment-wise alpha level of 5%.|Odds Ratio (OR)|1.2|||<|0.05|TWO_SIDED|95.0|0.8|1.8|||Wilcoxon (Mann-Whitney)||Crinone is the numerator and IM Progesterone is the denominator.|||1.8|0.8|<0.05
70861792|NCT02103218|141210256|SUPERIORITY|||||||0.47|||||||logistic GEE|||Results from logistic GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares predicted probabilities converted to %, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.47
70861793|NCT02103218|141210257|SUPERIORITY|||||||0.29|||||||logistic GEE|||Results from logistic GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares predicted probabilities converted to %, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.29
70861794|NCT02103218|141210258|SUPERIORITY||||||<|0.001|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||<0.001
70861795|NCT02103218|141210259|SUPERIORITY|||||||0.02||||||Omnibus overall test for any group x time interaction was p = 0.77.|linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.02
70861796|NCT02103218|141210260|SUPERIORITY|||||||0.67|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.67
70861797|NCT02103218|141210261|SUPERIORITY|||||||0.45|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.45
70861798|NCT02103218|141210262|SUPERIORITY|||||||0.7|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.70
70861799|NCT02103218|141210263|SUPERIORITY|||||||0.42|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.42
70861800|NCT02103218|141210264|SUPERIORITY|||||||0.63|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.63
70861801|NCT02103218|141210265|SUPERIORITY|||||||0.05||||||Omnibus overall test for any group x time interaction was p = 0.78.|count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.05
70861802|NCT02103218|141210266|SUPERIORITY|||||||0.5|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.50
70861803|NCT02103218|141210268|SUPERIORITY|||||||0.86|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.86
70861804|NCT02103218|141210269|SUPERIORITY|||||||0.46|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.46
70872144|NCT03808493|141229523|EQUIVALENCE|For log-transformed (natural log) λz, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|-0.0135|||||TWO_SIDED|90.0|-0.0508|0.0238||||||||0.0238|-0.0508|
70861805|NCT02103218|141210270|SUPERIORITY|||||||0.7|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.70
70861806|NCT02103218|141210271|SUPERIORITY|||||||0.29|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.29
70861807|NCT02103218|141210272|SUPERIORITY|||||||0.43|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.43
70861808|NCT02567552|141210276|OTHER|||||||0.3395|||||||Chi-squared|||||||0.3395
70861809|NCT02567552|141210277|OTHER|||||||0.1523|||||||Chi-squared|||||||0.1523
70861810|NCT02567552|141210278|OTHER|||||||0.1189|||||||t-test, 2 sided|||comparison between groups||||0.1189
71134247|NCT02524171|141771114|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)]|0.07|||<|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||<0.05
70861811|NCT02567552|141210280|OTHER|||||||0.2042|||||||t-test, 2 sided|||||||0.2042
70861812|NCT02567552|141210281|OTHER|||||||0.6262|||||||t-test, 2 sided|||||||0.6262
70861813|NCT02567552|141210282|OTHER|||||||0.2301|||||||t-test, 2 sided|||||||0.2301
71134248|NCT02524171|141771114|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)]|0.08|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63).||||>0.05
70861814|NCT02567552|141210283|OTHER|||||||0.5118|||||||t-test, 2 sided|||||||0.5118
70861815|NCT02567552|141210284|OTHER|||||||0.8371|||||||t-test, 2 sided|||||||0.8371
71134249|NCT00940901|141771115|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Null hypothesis: there would be no difference in the number of participants who experienced at least a 50% reduction in the frequency of priapic episodes between baseline and 8 weeks post intervention, between the sildenafil and placebo groups||||1
71134250|NCT00940901|141771116|SUPERIORITY_OR_OTHER|||||||0.55|||||||Fisher Exact|||||||0.55
70861816|NCT02567552|141210285|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70861817|NCT02567552|141210286|OTHER|||||||0.3107|||||||t-test, 2 sided|||||||0.3107
70861818|NCT02567552|141210287|OTHER|||||||0.5|||||||Fisher Exact|||||||0.5
70861819|NCT02452697|141210305|SUPERIORITY|||||||0.4|||||||Log Rank|||||||0.40
70861820|NCT03552965|141210319|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=1.14, SD=0.378, Range=1, 25th percentile=1, Median=1, 75th percentile=1, n=7 Robust: Mean=1.17, SD=0.577, Range=2, 25th percentile=1, Median=1, 75th percentile=1, n=12"|||
70861821|NCT03552965|141210320|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=2, SD=0.894, Range=2, 25th percentile=1, Median=2, 75th percentile=3, n=6 Robust: Mean=2.91, SD=1.136, Range=3, 25th percentile=2, Median=3, 75th percentile=4, n=11"|||
70861822|NCT03552965|141210321|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=2.5, SD=0.577, Range=1, 25th percentile=2, Median=2.5, 75th percentile=3, n=4 Robust: Mean=2.33, SD=1.225, Range=3, 25th percentile=1, Median=2, 75th percentile=3.5, n=9"|||
70861823|NCT03552965|141210322|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=1.83, SD=0.753, Range=2, 25th percentile=1, Median=2, 75th percentile=2.25, n=6 Robust: Mean=2.33, SD=1, Range=3, 25th percentile=1.5, Median=2, 75th percentile=3, n=9"|||
70861824|NCT03552965|141210323|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=2, SD=0.707, Range=2, 25th percentile=1.5, Median=2, 75th percentile=2.5, n=5 Robust: Mean=2.38, SD=1.188, Range=3, 25th percentile=1.25, Median=2, 75th percentile=3.75, n=8"|||
70861825|NCT03552965|141210324|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=15.5, SD=23.76242, Range=75, 25th percentile=0, Median=5, 75th percentile=21.25, n=10 Robust: Mean=14.1346, SD=17.87095, Range=52.5, 25th percentile=0, Median=6.25, 75th percentile=27.5, n=13"|||
70861826|NCT03552965|141210325|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=45.625, SD=30.68744, Range=71.25, 25th percentile=11.25, Median=58.125, 75th percentile=71.25, n=6 Robust: Mean=64.3182, SD=15.0142, Range=48.75, 25th percentile=66.25, Median=70, 75th percentile=71.25, n=11"|||
70861827|NCT03552965|141210326|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=60, SD=23.68412, Range=60, 25th percentile=38.125, Median=68.75, 75th percentile=77.5, n=5 Robust: Mean=54.8611, SD=29.91815, Range=80, 25th percentile=24.375, Median=66.25, 75th percentile=80, n=9"|||
70861828|NCT03552965|141210327|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=31.67, SD=31.38139, Range=85, 25th percentile=5.625, Median=25, 75th percentile=56.875, n=6 Robust: Mean=54.0278, SD=24.57274, Range=67.5, 25th percentile=33.75, Median=62.5, 75th percentile=72.5, n=9"|||
70861829|NCT03552965|141210328|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=50.75, SD=30.29284, Range=72.5, 25th percentile=21.875, Median=48.75, 75th percentile=80.625, n=5 Robust: Mean=38.4375, SD=26.69897, Range=66.25, 25th percentile=15, Median=29.375, 75th percentile=68.75, n=8"|||
70861830|NCT02477696|141210329|NON_INFERIORITY|Non-inferiority of acalabrutinib was demonstrated if the upper bound of the 2-sided 95% confidence interval (CI) of the hazard ratio was below 1.429.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.79|1.27|||||Cox Proportional Hazards model stratified by 17p deletion status (yes versus no) and number of prior therapies (1-3 versus \>=4).|||1.27|0.79|
70861831|NCT05419908|141210341|SUPERIORITY||LSMean Difference|-12.34|||<|0.001|TWO_SIDED|95.0|-16.89|-7.79||Least square (LS) mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|Analysis of Covariance (ANCOVA)||||-7.79|-16.89|<0.001
70861832|NCT05419908|141210342|SUPERIORITY||LSMean Difference|-1.134|||<|0.001|TWO_SIDED|95.0|-1.466|-0.802||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 4||-0.802|-1.466|<0.001
70861833|NCT05419908|141210342|SUPERIORITY||LSMean Difference|-0.948|||<|0.001||95.0|-1.362|-0.535||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 8||-0.535|-1.362|<0.001
70861834|NCT05419908|141210342|SUPERIORITY||LSMean Difference|-1.122|||<|0.001|TWO_SIDED|95.0|-1.504|-0.741||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 12||-0.741|-1.504|<0.001
70861835|NCT05419908|141210343|SUPERIORITY||LSMean Difference|-13.28|||<|0.001||95.0|-17.02|-9.54||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 4||-9.54|-17.02|<0.001
70861836|NCT05419908|141210343|SUPERIORITY||LSMean Difference|-11.78|||<|0.001|TWO_SIDED|95.0|-16.3|-7.27||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 8||-7.27|-16.30|<0.001
70861837|NCT05419908|141210343|SUPERIORITY||LSMean Difference|-12.42|||<|0.001||95.0|-17.0|-7.83||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 12||-7.83|-17.00|<0.001
70861838|NCT05419908|141210344|SUPERIORITY||LSMean Difference|-39.8|||<|0.001|TWO_SIDED|95.0|-50.5|-29.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as factor. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 4||-29.1|-50.5|<0.001
70861839|NCT05419908|141210344|SUPERIORITY||LSMean Difference|-35.5|||<|0.001|TWO_SIDED|95.0|-47.9|-23.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as factor. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 8||-23.0|-47.9|<0.001
70861840|NCT05419908|141210344|SUPERIORITY||LSMean Difference|-35.0|||<|0.001||95.0|-47.9|-22.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as factor. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 12||-22.1|-47.9|<0.001
70861841|NCT05419908|141210345|SUPERIORITY||Percentage Difference|65.1|||<|0.001|TWO_SIDED|95.0|49.15|81.0||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 4||81.00|49.15|<0.001
70861842|NCT05419908|141210345|SUPERIORITY||Percentage Difference|48.5|||<|0.001||95.0|30.37|66.59||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 8||66.59|30.37|<0.001
70861843|NCT05419908|141210345|SUPERIORITY||Percentage Difference|52.5|||<|0.001|TWO_SIDED|95.0|35.76|69.24||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 12||69.24|35.76|<0.001
70861844|NCT05419908|141210346|SUPERIORITY||Percentage Difference|69.0|||<|0.001|TWO_SIDED|95.0|53.7|84.21||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 4||84.21|53.70|<0.001
70861845|NCT05419908|141210346|SUPERIORITY||Percentage Difference|50.7|||<|0.001||95.0|31.93|69.42||Likelihood-ratio test based 95% confidence interval of the percentage difference|Likelihood-Ratio Chi-Square Test|||Week 8||69.42|31.93|<0.001
70861846|NCT05419908|141210346|SUPERIORITY||Percentage Difference|57.5|||<|0.001|TWO_SIDED|95.0|39.99|75.01||Likelihood-ratio test based 95% confidence interval of the percentage difference|Likelihood-Ratio Chi-Square Test|||Week 12||75.01|39.99|<0.001
70861847|NCT05419908|141210347|SUPERIORITY||Percentage Difference|54.2|||<|0.001|TWO_SIDED|95.0|37.47|70.84||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 4||70.84|37.47|<0.001
70861848|NCT05419908|141210347|SUPERIORITY||Percentage Difference|47.8|||<|0.001||95.0|29.62|65.99||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 8||65.99|29.62|<0.001
70947905|NCT02641587|141396715|OTHER|"The analysis will test if the geometric LS mean level of MHBMA for CHTP is lower than for CC. The following hypothesis will be evaluated:~H0: XCHTP - XCC ≤ 0.0~HA: XCHTP - XCC \> 0.0~where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test)."|LS Mean Reduction|85.01|||<|0.001|TWO_SIDED|95.0|82.06|87.47||The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|Generalized linear model||Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC \[%\]), and their 95% CI.|Analysis will be conducted on the natural log scale. The Day 5 levels of MHBMA will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of MHBMA.||87.47|82.06|<0.001
70954370|NCT03568318|141411397|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|50.6|||<|0.001|TWO_SIDED|95.0|43.8|57.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||57.3|43.8|<0.001
70861849|NCT05419908|141210347|SUPERIORITY||Percentage Difference|47.5|||<|0.001||95.0|28.86|66.14||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 12||66.14|28.86|<0.001
70861850|NCT05419908|141210348|SUPERIORITY||Percentage Difference|49.7|||<|0.001||95.0|33.54|65.79||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 4||65.79|33.54|<0.001
71134251|NCT00757237|141771117|NON_INFERIORITY_OR_EQUIVALENCE|The treatment difference (TIS-AZLI) and standard error from the ANCOVA model were used to compute the two-sided 95% confidence interval. If the 95% upper boundary was less than the pre-specified non-inferiority margin of 4%, then the null hypothesis was rejected.|Mean Difference (Final Values)|-7.8||||0.0001|TWO_SIDED|95.0|-11.73|-3.86||Based on the Benjamini \& Hochberg method, non-inferiority at Day 28 for relative change in FEV1 percent predicted was assessed at the 0.05 level, given the significance of the coprimary endpoint (p\<0.05).|ANCOVA|ANCOVA model included treatment, Day 0 FEV1 percent predicted, and previous inhaled tobramycin use for all participants.|Treatment difference refers to TIS-AZLI.|Null hypothesis: AZLI was inferior to TIS by more than 4% in the mean relative change of FEV1 percent predicted at Day 28. With 120 subjects per treatment group there was at least 85% power to declare noninferiority based on relative change from baseline at Day 28 in FEV1 percent predicted using the upper bound of a 2-tailed 95% CI for the difference in means with a noninferiority margin of 4, assuming a common standard deviation of 18% and true difference in means \[TIS-AZLI\] of -3.2%.||-3.86|-11.73|0.0001
71134252|NCT00757237|141771118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.0023||||||Based on the Benjamini \& Hochberg method, superiority at Weeks 4, 12, and 20 of actual change in FEV1 percent predicted was tested at the 0.05 level, given the significance of the coprimary endpoint (p\<0.05).|MMRM analysis|MMRM analysis included Day 0 FEV1 percent predicted, previous inhaled tobramycin use, treatment, visit, and treatment/visit interaction.|Treatment difference refers to TIS-AZLI.|"Null hypothesis: there was no difference between AZLI and TIS treatment groups in the mean actual change of FEV1 percent predicted across 3 treatment courses among all participants.~With 120 subjects per treatment group, there was at least 90% power at a 5% significance level to detect differences based upon actual change from baseline in FEV1 percent predicted (3.61%, 2.98%, 2.32%) between AZLI and TIS at Weeks 4, 12, and 20 with a common standard deviation of 9%."||||0.0023
71134253|NCT00757237|141771119|NON_INFERIORITY_OR_EQUIVALENCE|The treatment difference (TIS-AZLI) and standard error from the ANCOVA model were used to compute the two-sided 95% confidence interval. If the 95% upper boundary was less than the pre-specified non-inferiority margin of 4%, then the null hypothesis was rejected.|Mean Difference (Final Values)|-9.5|||<|0.0001|TWO_SIDED|95.0|-13.86|-5.14||Secondary endpoints were tested sequentially by the closed testing procedure initiated by the significance of the primary endpoints. Given the coprimary endpoints were met at the 0.05 level, this non-inferiority endpoint was tested at the 0.05 level.|ANCOVA|ANCOVA model included treatment and Day 0 FEV1 percent predicted.|Treatment difference refers to TIS-AZLI.|Null hypothesis: AZLI was inferior to TIS by more than 4% in terms of the participant means in relative change of FEV1 percent predicted at Day 28 among all participants having \>= 84 days of inhaled tobramycin use in the previous 12 months.||-5.14|-13.86|<0.0001
71134254|NCT00757237|141771120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47||||0.0002||||||Secondary endpoints were tested sequentially to control the Type I error rate based on the closed testing procedure. Given the significance of the coprimary endpoints and previous secondary endpoint, this endpoint was also tested at the 0.05 level.|MMRM analysis|MMRM analysis included treatment, Day 0 FEV1 percent predicted, visit, treatment, and treatment/visit interaction for all participants.|Treatment difference refers to TIS-AZLI|Null hypothesis: there was no difference between AZLI and TIS treatment groups in the mean actual change of FEV1 percent predicted across 3 treatment courses in the stratum of subjects having \>=84 days of inhaled tobramycin use in the previous 12 months.||||0.0002
70861851|NCT05419908|141210348|SUPERIORITY||Percentage Difference|43.8|||<|0.001|TWO_SIDED|95.0|27.83|59.85||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 8||59.85|27.83|<0.001
70861852|NCT05419908|141210348|SUPERIORITY||Percentage Difference|42.5|||<|0.001||95.0|26.34|58.66||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 12||58.66|26.34|<0.001
70861853|NCT05419908|141210349|SUPERIORITY||Percentage Difference|62.8|||<|0.001|TWO_SIDED|95.0|46.56|79.05||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 4||79.05|46.56|<0.001
70861854|NCT05419908|141210349|SUPERIORITY||Percentage Difference|46.2|||<|0.001|TWO_SIDED|95.0|28.85|63.47||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 8||63.47|28.85|<0.001
70861855|NCT05419908|141210349|SUPERIORITY||Percentage Difference|57.5|||<|0.001|TWO_SIDED|95.0|41.57|73.43||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 12||73.43|41.57|<0.001
70861856|NCT05419908|141210350|SUPERIORITY||Percentage Difference|61.5|||<|0.001||95.0|45.4|77.55||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 4||77.55|45.40|<0.001
70861857|NCT05419908|141210350|SUPERIORITY||Percentage Difference|43.1|||<|0.001|TWO_SIDED|95.0|23.53|62.69||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 8||62.69|23.53|<0.001
70861858|NCT05419908|141210350|SUPERIORITY||Percentage Difference|52.5|||<|0.001||95.0|33.92|71.08||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 12||71.08|33.92|<0.001
70861859|NCT05419908|141210351|SUPERIORITY||LSMean Difference|-2.53|||<|0.001|TWO_SIDED|95.0|-3.45|-1.6||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Work||-1.60|-3.45|<0.001
70861860|NCT05419908|141210351|SUPERIORITY||LSMean Difference|-2.29|||<|0.001|TWO_SIDED|95.0|-3.15|-1.42||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Work||-1.42|-3.15|<0.001
70861861|NCT05419908|141210351|SUPERIORITY||LSMean Difference|-2.11|||<|0.001|TWO_SIDED|95.0|-3.03|-1.2||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Work||-1.20|-3.03|<0.001
70861862|NCT05419908|141210351|SUPERIORITY||LSMean Difference|-2.33|||<|0.001|TWO_SIDED|95.0|-3.19|-1.46||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Social Activities||-1.46|-3.19|<0.001
70861863|NCT05419908|141210351|SUPERIORITY||LSMean Difference|-2.34|||<|0.001|TWO_SIDED|95.0|-3.21|-1.47||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Social Activties||-1.47|-3.21|<0.001
70861864|NCT05419908|141210351|SUPERIORITY||LSMean Difference|-2.19|||<|0.001|TWO_SIDED|95.0|-3.09|-1.29||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Social Activties||-1.29|-3.09|<0.001
70861865|NCT05419908|141210351|SUPERIORITY||LSMean Difference|-2.15|||<|0.001|TWO_SIDED|95.0|-2.99|-1.31||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Leisure Activities||-1.31|-2.99|<0.001
70861866|NCT05419908|141210351|SUPERIORITY||LSMean Difference|-2.37|||<|0.001|TWO_SIDED|95.0|-3.19|-1.55||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Leisure Activties||-1.55|-3.19|<0.001
70861867|NCT05419908|141210351|SUPERIORITY||LSMean Difference|-1.64||||0.002|TWO_SIDED|95.0|-2.66|-0.62||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Leisure Activties||-0.62|-2.66|0.002
70861868|NCT05419908|141210351|SUPERIORITY||LSMean Difference|-2.93|||<|0.001|TWO_SIDED|95.0|-4.08|-1.78||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Sleep||-1.78|-4.08|<0.001
70861869|NCT05419908|141210351|SUPERIORITY||LSMean Difference|-2.71|||<|0.001|TWO_SIDED|95.0|-3.86|-1.57||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Sleep||-1.57|-3.86|<0.001
70861870|NCT05419908|141210351|SUPERIORITY||LSMean Difference|-2.61|||<|0.001|TWO_SIDED|95.0|-3.67|-1.54||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Sleep||-1.54|-3.67|<0.001
70861871|NCT05419908|141210351|SUPERIORITY||LSMean Difference|-1.74|||<|0.001|TWO_SIDED|95.0|-2.67|-0.81||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Mood||-0.81|-2.67|<0.001
70861872|NCT05419908|141210351|SUPERIORITY||LSMean Difference|-2.12|||<|0.001|TWO_SIDED|95.0|-3.09|-1.16||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Mood||-1.16|-3.09|<0.001
71134255|NCT00757237|141771121|SUPERIORITY_OR_OTHER|||||||0.0025|TWO_SIDED|||||Secondary endpoints were tested sequentially to control the Type I error rate based on the closed testing procedure. Given the significance of the coprimary endpoints and previous secondary endpoint, this endpoint was also tested at the 0.05 level.|Log Rank|||Null hypothesis: there was no difference between AZLI and TIS treatment groups with respect to time to need for IV antipseudomonal antibiotics for respiratory events.||||0.0025
71134256|NCT00757237|141771122|SUPERIORITY_OR_OTHER|||||||0.1114||||||Secondary endpoints were tested sequentially to control the Type I error rate based on the closed testing procedure. Given the significance of the coprimary endpoints and previous secondary endpoint, this endpoint was also tested at the 0.05 level.|Log Rank|||Null hypothesis: there was no difference between AZLI and TIS treatment groups with respect to time to first respiratory hospitalization.||||0.1114
71134257|NCT00757237|141771123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.61||||0.0048||0.0||||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, Day 0 FEV1 percent predicted, Day 0 CFQ-R RSS score, and previous inhaled tobramycin use.|Treatment difference refers to TIS-AZLI.|Null hypothesis: there was no difference between AZLI and TIS treatment groups in change from baseline in CFQ-R RSS scores at Day 28.||||0.0048
71134258|NCT00757237|141771124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.13||||0.0189||0.0||||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, Day 0 FEV1 percent predicted, Day 0 CFQ-R RSS score, and previous inhaled tobramycin use.|Treatment difference refers to TIS-AZLI.|Null hypothesis: there was no difference between AZLI and TIS treatment groups in the average actual change in respiratory symptoms at the end of each treatment course (Weeks 4, 12, and 20).||||0.0189
71134259|NCT00757237|141771125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.12||||0.0097||0.0||||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, Day 0 FEV1 percent predicted, and previous inhaled tobramycin use.|Treatment difference refers to TIS-AZLI.|Null hypothesis: there was no difference between AZLI and TIS treatment groups in the global satisfaction results of the TSQM at Week 20 (Day 140).||||0.0097
71134260|NCT00757237|141771126|SUPERIORITY_OR_OTHER|||||||0.044||||||No adjustments were made for multiple comparisons.|negative binomial regression method|||Null hypothesis: there was no difference between AZLI and TIS treatment groups in the total number of respiratory hospitalizations from Day 0 to Day 168 (end of study).||||0.044
71134261|NCT00757237|141771127|SUPERIORITY_OR_OTHER|||||||0.004||0.0||||No adjustments were made for multiple comparisons.|negative binomial regression method|||Null hypothesis: there was no difference between AZLI and TIS treatment groups in the total number of respiratory events requiring IV and/or inhaled antipseudomonal antibiotics (other than randomized treatment) from Day 0 to Day 168 (end of study).||||0.004
71134262|NCT00757237|141771128|SUPERIORITY_OR_OTHER|||||||0.0004||||||No adjustments were made for multiple comparisons.|Log Rank|||Null hypothesis: there was no difference between AZLI and TIS treatment groups with respect to time to need for inhaled and/or IV antipseudomonal antibiotics for respiratory events.||||0.0004
71134263|NCT01219985|141771160|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||McNemar|||We performed a McNemar test to compare the sensitivities obtained for each PET image method||||<0.001
71134264|NCT01219985|141771161|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||The null hypothesis was : lesions' SUVmax are equivalent with our without application of the CT-Based respiratory-gated PET method.||||<0.001
71134265|NCT04797780|141771162|SUPERIORITY||Difference in CR Rate|5.06||||0.2084|TWO_SIDED|95.0|-7.1|17.2|||Cochran-Mantel-Haenszel|||||17.2|-7.1|0.2084
71134266|NCT02863328|141771180|NON_INFERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand). A value of 0.4% (the non-inferiority margin) was added to imputed values at week 26 for the oral semaglutide treatment arm only.|Treatment difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.3||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.4%.|Pattern mixture model||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.3|-0.6|< 0.0001
71134267|NCT02863328|141771180|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.3||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.3|-0.6|< 0.0001
70861873|NCT05419908|141210351|SUPERIORITY||LSMean Difference|-1.79|||<|0.001|TWO_SIDED|95.0|-2.69|-0.88||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Mood||-0.88|-2.69|<0.001
70861874|NCT05419908|141210351|SUPERIORITY||LSMean Difference|-1.92|||<|0.001|TWO_SIDED|95.0|-2.86|-0.97||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Concentration||-0.97|-2.86|<0.001
70861875|NCT05419908|141210351|SUPERIORITY||LSMean Difference|-2.23|||<|0.001|TWO_SIDED|94.0|-3.21|-1.25||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Concentration||-1.25|-3.21|<0.001
71134268|NCT02863328|141771180|NON_INFERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.4||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.4%.|MMRM||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.4|-0.7|<0.0001
71134269|NCT02863328|141771180|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.4||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.4|-0.7|<0.0001
70861876|NCT05419908|141210351|SUPERIORITY||LSMean Difference|-1.9|||<|0.001|TWO_SIDED|95.0|-2.91|-0.88||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Concentration||-0.88|-2.91|<0.001
70861877|NCT05419908|141210351|SUPERIORITY||LSMean Difference|-1.33||||0.003|TWO_SIDED|95.0|-2.2|-0.46||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Relations With Others||-0.46|-2.20|0.003
70861878|NCT05419908|141210351|SUPERIORITY||LSMean Difference|-1.85|||<|0.001|TWO_SIDED|95.0|-2.8|-0.9||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Relations With others||-0.90|-2.80|<0.001
70861879|NCT05419908|141210351|SUPERIORITY||LSMean Difference|-1.72|||<|0.001|TWO_SIDED|95.0|-2.66|-0.77||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Relations With Others||-0.77|-2.66|<0.001
70861880|NCT05419908|141210351|SUPERIORITY||LSMean Difference|-1.06||||0.081|TWO_SIDED|95.0|-2.25|0.13||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Sexuality||0.13|-2.25|0.081
70861881|NCT05419908|141210351|SUPERIORITY||LSMean Difference|-1.4||||0.05|TWO_SIDED|95.0|-2.8|0.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Sexuality||0.00|-2.80|0.050
70861882|NCT05419908|141210351|SUPERIORITY||LSMean Difference|-1.51||||0.026|TWO_SIDED|95.0|-2.84|-0.19||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Sexuality||-0.19|-2.84|0.026
70861883|NCT05419908|141210351|SUPERIORITY||LSMean Difference|-1.65|||<|0.001|TWO_SIDED|95.0|-2.51|-0.79||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Enjoyment of Life||-0.79|-2.51|<0.001
70861884|NCT05419908|141210351|SUPERIORITY||LSMean Difference|-2.07|||<|0.001|TWO_SIDED|95.0|-2.97|-1.18||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Enjoyment of Life||-1.18|-2.97|<0.001
71134270|NCT02863328|141771181|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.1|||=|0.7593|TWO_SIDED|95.0|-0.7|0.5||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.5|-0.7|= 0.7593
70861885|NCT05419908|141210351|SUPERIORITY||LSMean Difference|-1.83|||<|0.001|TWO_SIDED|95.0|-2.88|-0.78||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Enjoyment of Life||-0.78|-2.88|<0.001
70861886|NCT05419908|141210351|SUPERIORITY||LSMean difference|-1.92|||<|0.001|TWO_SIDED|95.0|-2.86|-0.97||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week4: Overall Quality of Life||-0.97|-2.86|<0.001
70861887|NCT05419908|141210351|SUPERIORITY||LSMean Difference|-2.51|||<|0.001|TWO_SIDED|95.0|-3.41|-1.61||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Overall Quality of Life||-1.61|-3.41|<0.001
70861888|NCT05419908|141210351|SUPERIORITY||LSMean Difference|-2.36|||<|0.001|TWO_SIDED|95.0|-3.31|-1.41||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Overall Quality of Life||-1.41|-3.31|<0.001
70861889|NCT05419908|141210351|SUPERIORITY||LSMean Difference|-1.98|||<|0.001|TWO_SIDED|95.0|-2.73|-1.23||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Overall Mean Score||-1.23|-2.73|<0.001
70861890|NCT05419908|141210351|SUPERIORITY||LSMean Difference|-2.21|||<|0.001|TWO_SIDED|95.0|-3.02|-1.4||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Overall Mean Score||-1.40|-3.02|<0.001
70861891|NCT05419908|141210351|SUPERIORITY||LSMean Difference|-1.98|||<|0.001|TWO_SIDED|95.0|-2.83|-1.13||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Overall Mean Score||-1.13|-2.83|<0.001
70861892|NCT05419908|141210352|SUPERIORITY||LSMean Difference|1.375|||<|0.001|TWO_SIDED|95.0|0.651|2.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 4: Getting to Sleep||2.100|0.651|<0.001
70954371|NCT03568318|141411397|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|37.4|||<|0.001|TWO_SIDED|95.0|30.4|44.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||44.3|30.4|<0.001
71134271|NCT02863328|141771181|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-0.4|||=|0.1358|TWO_SIDED|95.0|-1.0|0.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||0.1|-1.0|= 0.1358
70861893|NCT05419908|141210352|SUPERIORITY||LSMean Difference|1.166|||<|0.001|TWO_SIDED|95.0|0.505|1.827||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 8: Getting to Sleep||1.827|0.505|<0.001
70861894|NCT05419908|141210352|SUPERIORITY||LSMean Difference|0.895||||0.014|TWO_SIDED|95.0|0.19|1.599||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 12: Getting to Sleep||1.599|0.190|0.014
70861895|NCT05419908|141210352|SUPERIORITY||LSMean Difference|2.423|||<|0.001|TWO_SIDED|95.0|1.308|3.539||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 4: Quality of Sleep||3.539|1.308|<0.001
70861896|NCT05419908|141210352|SUPERIORITY||LSMean Difference|2.291|||<|0.001|TWO_SIDED|95.0|1.31|3.251||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 8: Quality of Sleep||3.251|1.31|<0.001
70861897|NCT05419908|141210352|SUPERIORITY||LSMean Difference|2.433|||<|0.001|TWO_SIDED|95.0|1.334|3.532||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 12: Quality of Sleep||3.532|1.334|<0.001
70861898|NCT05419908|141210352|SUPERIORITY||LSMean Difference|0.877||||0.059|TWO_SIDED|95.0|-0.034|1.789||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 4: Awake Following Sleep||1.789|-0.034|0.059
70861899|NCT05419908|141210352|SUPERIORITY||LSMean Difference|1.457||||0.001|TWO_SIDED|95.0|0.579|2.335||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 8: Awake Following Sleep||2.335|0.579|0.001
70861900|NCT05419908|141210352|SUPERIORITY||LSMean Difference|1.113||||0.031|TWO_SIDED|95.0|0.107|2.12||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 12: Awake Following Sleep||2.120|0.107|0.031
70861901|NCT05419908|141210352|SUPERIORITY||LSMean Difference|1.203||||0.008|TWO_SIDED|95.0|0.317|2.088||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 4: Behaviour Following Wakening||2.088|0.317|0.008
70861902|NCT05419908|141210352|SUPERIORITY||LSMean Difference|1.597||||0.001|TWO_SIDED|95.0|0.639|2.556||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 8: Behaviour Following Wakening||2.556|0.639|0.001
70861903|NCT05419908|141210352|SUPERIORITY||LSMean Difference|0.842||||0.084|TWO_SIDED|95.0|-0.116|1.8||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 12: Behaviour Following Sleep||1.800|-0.116|0.084
70861904|NCT05419908|141210353|SUPERIORITY||LSMean Difference|0.0||||0.881|TWO_SIDED|95.0|-0.3|0.3||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 4: Loss of Interest in Sex||0.3|-0.3|0.881
70861905|NCT05419908|141210353|SUPERIORITY||LSMean Difference|-0.2||||0.383|TWO_SIDED|95.0|-0.6|0.2||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 8: Loss of Interest in Sex||0.2|-0.6|0.383
70861906|NCT05419908|141210353|SUPERIORITY||LSMean Difference|-0.2||||0.301|TWO_SIDED|95.0|-0.6|0.2||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 12: Loss of Interest in Sex||0.2|-0.6|0.301
70861907|NCT05419908|141210353|SUPERIORITY||LSMean Difference|-2.5||||0.02|TWO_SIDED|95.0|-4.5|-0.4||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 4: Psychological||-0.4|-4.5|0.020
70861908|NCT05419908|141210353|SUPERIORITY||LSMean Difference|-3.3||||0.003|TWO_SIDED|95.0|-5.4|-1.2||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 8: Psychological||-1.2|-5.4|0.003
70861909|NCT05419908|141210353|SUPERIORITY||LSMean Difference|-3.1||||0.005|TWO_SIDED|95.0|-5.2|-1.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 12: Psychological||-1.0|-5.2|0.005
70861910|NCT05419908|141210353|SUPERIORITY||LSMean Difference|-0.2||||0.732|TWO_SIDED|95.0|-1.2|0.9||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 4: Physical||0.9|-1.2|0.732
70861911|NCT05419908|141210353|SUPERIORITY||LSMean Difference|-0.7||||0.282|TWO_SIDED|95.0|-1.9|0.6||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 8: Physical||0.6|-1.9|0.282
70861912|NCT05419908|141210353|SUPERIORITY||LSMean Difference|-0.6||||0.254|TWO_SIDED|95.0|-1.7|0.5||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 12: Physical||0.5|-1.7|0.254
70861913|NCT05419908|141210353|SUPERIORITY||LSMean Difference|-2.0|||<|0.001|TWO_SIDED|95.0|-2.7|-1.4||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 4: Vasomotor||-1.4|-2.7|<0.001
70861914|NCT05419908|141210353|SUPERIORITY||LSMean Difference|-1.8|||<|0.001|TWO_SIDED|95.0|-2.4|-1.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 8: Vasomotor||-1.1|-2.4|<0.001
70861915|NCT05419908|141210353|SUPERIORITY||LSMean Difference|-2.0|||<|0.001|TWO_SIDED|95.0|-2.6|-1.3||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 12: Vasomotor||-1.3|-2.6|<0.001
70861916|NCT05419908|141210353|SUPERIORITY||LSMean Difference|-4.6||||0.013|TWO_SIDED|95.0|-8.2|-1.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 4: Total Symptom Score||-1.0|-8.2|0.013
70861917|NCT05419908|141210353|SUPERIORITY||LSMean Difference|-6.9|||<|0.001|TWO_SIDED|95.0|-10.7|-3.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 8: Total Symptom Score||-3.1|-10.7|<0.001
70861918|NCT05419908|141210353|SUPERIORITY||LSMean Difference|-6.3|||<|0.001|TWO_SIDED|95.0|-9.9|-2.8||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 12: Total Symptom Score||-2.8|-9.9|<0.001
70861919|NCT05419908|141210354|SUPERIORITY||LSMean Difference|-1.7|||<|0.001|TWO_SIDED|95.0|-2.7|-0.8||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 4: Work/School||-0.8|-2.7|<0.001
70861920|NCT05419908|141210354|SUPERIORITY||LSMean Difference|-2.0|||<|0.001|TWO_SIDED|95.0|-2.8|-1.3||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 8: Work/School||-1.3|-2.8|<0.001
70861921|NCT05419908|141210354|SUPERIORITY||LSMean Difference|-1.6|||<|0.001|TWO_SIDED|95.0|-2.5|-0.8||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 12: Work/School||-0.8|-2.5|<0.001
70861922|NCT05419908|141210354|SUPERIORITY||LSMean Difference|-1.4|||<|0.001|TWO_SIDED|95.0|-2.2|-0.6||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 4: Social Life||-0.6|-2.2|<0.001
70861923|NCT05419908|141210354|SUPERIORITY||LSMean Difference|-1.9|||<|0.001|TWO_SIDED|95.0|-2.7|-1.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 8: Social Life||-1.1|-2.7|<0.001
70861924|NCT05419908|141210354|SUPERIORITY||LSMean Difference|-1.6|||<|0.001|TWO_SIDED|95.0|-2.4|-0.7||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 12: Social Life||-0.7|-2.4|<0.001
70861925|NCT05419908|141210354|SUPERIORITY||LSMean Difference|-1.3||||0.005|TWO_SIDED|95.0|-2.2|-0.4||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 4: Family Life/Home Responsibilities||-0.4|-2.2|0.005
70861926|NCT05419908|141210354|SUPERIORITY||LSMean Difference|-1.7|||<|0.001|TWO_SIDED|95.0|-2.5|-0.9||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 8: Family Life/Home Responsibilities||-0.9|-2.5|<0.001
70861927|NCT05419908|141210354|SUPERIORITY||LSMean Difference|-1.6|||<|0.001|TWO_SIDED|95.0|-2.4|-0.7||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 12: Family Life/Home Responsibilities||-0.7|-2.4|<0.001
70947906|NCT02641587|141396716|OTHER|"The analysis will test if the geometric LS mean level of 3-HPMA for CHTP is lower than for CC. The following hypothesis will be evaluated:~H0: XCHTP - XCC ≤ 0.0~HA: XCHTP - XCC \> 0.0~where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test)."|LS Mean Reduction|40.2|||<|0.001|TWO_SIDED|95.0|30.25|48.73||The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|Generalized linear model||Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC \[%\]), and their 95% CI.|Analysis will be conducted on the natural log scale. The Day 5 levels of 3-HPMA will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of 3-HPMA.||48.73|30.25|<0.001
70954372|NCT03568318|141411398|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|57.6|||<|0.001|TWO_SIDED|95.0|51.2|63.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||63.9|51.2|<0.001
70861928|NCT05419908|141210354|SUPERIORITY||LSMean Difference|-4.4|||<|0.001|TWO_SIDED|95.0|-6.9|-2.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 4: Global Functional Impairment||-2.0|-6.9|<0.001
70861929|NCT05419908|141210354|SUPERIORITY||LSMean Difference|-5.8|||<|0.001|TWO_SIDED|95.0|-8.0|-3.6||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 8: Global Functional Impairment||-3.6|-8.0|<0.001
70861930|NCT05419908|141210354|SUPERIORITY||LSMean Difference|-5.3|||<|0.001|TWO_SIDED|95.0|-7.8|-2.8||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 12: Global Functional Impairment||-2.8|-7.8|<0.001
70861931|NCT05419908|141210355|SUPERIORITY||LSMean difference|0.0||||0.936|TWO_SIDED|95.0|-0.5|0.6||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 4: Days Lost||0.6|-0.5|0.936
70861932|NCT05419908|141210355|SUPERIORITY||LSMean difference|0.0||||0.884|TWO_SIDED|95.0|-0.1|0.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 8: Days Lost||0.1|-0.1|0.884
70861933|NCT05419908|141210355|SUPERIORITY||LSMean difference|-0.2||||0.124|TWO_SIDED|95.0|-0.4|0.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 12: Days Lost||0.1|-0.4|0.124
70861934|NCT05419908|141210355|SUPERIORITY||LSMean difference|-0.9||||0.052|TWO_SIDED|95.0|-1.8|0.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 4: Days Unproductive||0.0|-1.8|0.052
70861935|NCT05419908|141210355|SUPERIORITY||LSMean difference|-0.9||||0.06||95.0|-1.7|0.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 8: Days Unproductive||0.0|-1.7|0.060
70861936|NCT05419908|141210355|SUPERIORITY||LSMean difference|-0.8||||0.049|TWO_SIDED|95.0|-1.7|0.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 12: Days Unproductive||0.0|-1.7|0.049
70861937|NCT00085709|141210367|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Cox|The interim analysis only reported a p-value for testing whether the hazard ratio was not equal to 1.5.||Interim futility analysis of the alternative hypothesis for disease-free survival. The design specified a hazard ratio of (observation: GO) of 1.5.||||<0.001
70861938|NCT00085709|141210368|SUPERIORITY_OR_OTHER||||||<|0.0025||95.0|||||Test of difference of proportions|||Interim futility analysis alternative hypothesis based on the design specification that the 7+3+GO arm would have a 12% increase in CR rate.||||<0.0025
70861939|NCT04622735|141210384|SUPERIORITY|||||||0.0031|||||||Mixed Models Analysis|||||||0.0031
70861940|NCT04622735|141210384|SUPERIORITY|||||||0.6787|||||||Mixed Models Analysis|||||||0.6787
70861941|NCT01325623|141210423|SUPERIORITY_OR_OTHER|||||||0.375|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to EMU Discharge||||0.375
70861942|NCT01325623|141210423|SUPERIORITY_OR_OTHER|||||||0.156|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 3 Months||||0.156
70861943|NCT01325623|141210423|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 6 months||||>0.999
70861944|NCT01325623|141210423|SUPERIORITY_OR_OTHER|||||||0.906|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 12 Months||||0.906
70861945|NCT01325623|141210423|SUPERIORITY_OR_OTHER|||||||0.188|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 18 Months||||0.188
70861946|NCT01325623|141210423|SUPERIORITY_OR_OTHER|||||||0.906|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 24 Months||||0.906
70861947|NCT01325623|141210423|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to EMU Discharge||||<0.001
70861948|NCT01325623|141210423|SUPERIORITY_OR_OTHER|||||||0.106|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 3 Months||||0.106
70861949|NCT01325623|141210423|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 6 Months||||0.012
70861950|NCT01325623|141210423|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||s|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 12 Months||||0.008
70861951|NCT01325623|141210423|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 18 Months||||0.009
70861952|NCT01325623|141210423|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 24 Months||||0.029
70861953|NCT01325623|141210423|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||s|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to EMU Discharge||||0.500
70861954|NCT01325623|141210423|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 3 Months||||>0.999
70861955|NCT01325623|141210423|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 6 Months||||0.500
70861956|NCT01325623|141210423|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 12 Months||||0.500
70861957|NCT01325623|141210423|SUPERIORITY_OR_OTHER|||||||0.188|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 18 Months||||0.188
70861958|NCT01325623|141210423|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 24 Months||||0.500
70861959|NCT01325623|141210423|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to EMU Discharge||||0.500
70861960|NCT01325623|141210423|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 3 Months||||>0.999
70861961|NCT01325623|141210423|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 6 Months||||>0.999
70861962|NCT01325623|141210423|SUPERIORITY_OR_OTHER|||||||0.125|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 12 Months||||0.125
70861963|NCT01325623|141210423|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 18 Months||||0.500
70861964|NCT01325623|141210423|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 24 Months||||0.500
70861965|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.1529|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.1529
70861966|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.0942|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score||||0.0942
70861967|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.2831|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.2831
70861968|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.3639|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.3639
70954373|NCT03568318|141411398|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|43.8|||<|0.001|TWO_SIDED|95.0|37.0|50.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||50.5|37.0|<0.001
71134272|NCT02863328|141771209|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.85||||0.3552|TWO_SIDED|95.0|0.6|1.2||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Empagliflozin 25 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.20|0.60|0.3552
70861969|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.447|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.4470
70861970|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.1311|TWO_SIDED||||||s|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.1311
70861971|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.3898|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.3898
70861972|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.0511|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.0511
70861973|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score||||0.0019
70947907|NCT02641587|141396717|OTHER|"The analysis will test if the geometric LS mean level of S-PMA for CHTP is lower than for CC. The following hypothesis will be evaluated:~H0: XCHTP - XCC ≤ 0.0~HA: XCHTP - XCC \> 0.0~where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test)."|LS Mean Reduction|83.9|||<|0.001|TWO_SIDED|95.0|81.61|85.9||The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|Generalized linear model||Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC \[%\]), and their 95% CI.|Analysis will be conducted on the natural log scale. The Day 5 levels of S-PMA will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of S-PMA.||85.90|81.61|<0.001
71134273|NCT02863328|141771210|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.75||||0.225|TWO_SIDED|95.0|0.47|1.19||Unadjusted two-sided p-value for test of no difference from 1.|Cox proportional hazards model||Oral semaglutide 14 mg / Empagliflozin 25 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||1.19|0.47|0.2250
71134274|NCT03152591|141771237|OTHER||Ratio LIK066/Placebo|0.88||||0.353|TWO_SIDED|90.0|0.7|1.11|||t-test, 2 sided|Two-sided test at the 0.1 significance level|||Log transformed ratio of Day 15 to baseline in average fasting free testosterone was analyzed using an analysis of covariance model which included treatment as a categorical factor, baseline body weight and log transformed baseline average fasting free testosterone as a covariate.|1.11|0.70|0.353
70861974|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.1106|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.1106
70861975|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.1273|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.1273
70861976|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.1305|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.1305
70861977|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.1123|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.1123
70861978|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.2309|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.2309
70861979|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.3191|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.3191
70861980|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.0679|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score||||0.0679
71134275|NCT03152591|141771238|OTHER||Ratio LIK066/Placebo|1.25||||0.218|TWO_SIDED|90.0|0.92|1.68|||t-test, 2 sided|Two-sided test at the 0.1 significance level|||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|1.68|0.92|0.218
71134276|NCT03152591|141771239|OTHER||Ratio LIK066/Placebo|1.27||||0.249|TWO_SIDED|90.0|0.9|1.78|||t-test, 2 sided|Two-sided test at the 0.1 significance level|||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|1.78|0.90|0.249
71134277|NCT03152591|141771240|OTHER||Ratio LIK066/Placebo|1.15||||0.173|TWO_SIDED|90.0|0.97|1.36|||t-test, 2 sided|Two-sided test at the 0.1 significance level|Values \< LLOQ and values \> ULOQ are imputed as LLOQ/2 and ULOQ respectively.||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|1.36|0.97|0.173
70861981|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.2082|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.2082
70861982|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.179|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.1790
70861983|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.6869|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.6869
70861984|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.6094|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.6094
71134278|NCT03152591|141771241|OTHER||Ratio LIK066/Placebo|0.82||||0.089|TWO_SIDED|90.0|0.68|0.99|||t-test, 2 sided|Two-sided test at the 0.1 significance level|Values \< LLOQ and values \> ULOQ are imputed as LLOQ/2 and ULOQ respectively||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|0.99|0.68|0.089
71134279|NCT03152591|141771242|OTHER||Ration LIK066/Placebo|0.69||||0.109|TWO_SIDED|90.0|0.48|1.01|||t-test, 2 sided|Two-sided test at the 0.1 significance level|Values \< LLOQ and values \> ULOQ are imputed as LLOQ/2 and ULOQ respectively.||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|1.01|0.48|0.109
71134280|NCT03152591|141771243|OTHER||Ration LIK066/Placebo|0.76||||0.008|TWO_SIDED|90.0|0.65|0.89|||t-test, 2 sided|Two-sided test at the 0.1 significance level|Values \< LLOQ and values \> ULOQ are imputed as LLOQ/2 and ULOQ respectively.||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|0.89|0.65|0.008
70861985|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.153|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.1530
70861986|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.3339|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.3339
70861987|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.1473|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score||||0.1473
70861988|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.5035|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.5035
70861989|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.6653|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.6653
70861990|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.8622|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.8622
70861991|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.4456|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.4456
70861992|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.6876|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.6876
70861993|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.0328|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.0328
70861994|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.0067|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score||||0.0067
70861995|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.5928|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.5928
70861996|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.7179|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.7179
70861997|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.5014|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.5014
70861998|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.964|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.9640
70861999|NCT01325623|141210424|SUPERIORITY_OR_OTHER|||||||0.8537|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.8537
70862000|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.2079|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total||||0.2079
70862001|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.6562|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final Score||||0.6562
70862002|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.9376|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being Final Score||||0.9376
70862003|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final Score||||0.0100
70862004|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.8532|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive functioning Final Score||||0.8532
70862005|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.4954|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects Final Score||||0.4954
71134281|NCT03152591|141771244|OTHER||Ratio LIK066/Placebo|0.91||||0.34|TWO_SIDED|90.0|0.77|1.07|||t-test, 2 sided|Two-sided test at the 0.1 significance level|||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|1.07|0.77|0.340
70862006|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.1877|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry Final Score||||0.1877
70862007|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.4189|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life Final Score||||0.4189
70862008|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.2365|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total Score||||0.2365
70862009|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.4138|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final Score||||0.4138
70862010|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.8701|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being Final Score||||0.8701
70862011|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.0527|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final Score||||0.0527
70862012|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.1353|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive functioning Final Score||||0.1353
70862013|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.6927|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects Final Score||||0.6927
70862014|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.4964|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry Final Score||||0.4964
70862015|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.0238|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life Final Score||||0.0238
70862016|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.0139|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total Score||||0.0139
70862017|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.2822|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final Score||||0.2822
70862018|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.1363|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being Final Score||||0.1363
70862019|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final Score||||0.0019
70862020|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.1293|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive functioning Final Score||||0.1293
70862021|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.5252|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects Final Score||||0.5252
70862022|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.0642|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry Final Score||||0.0642
70862023|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.0025|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life Final Score||||0.0025
70862024|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total Score||||0.0024
70862025|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.4464|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final Score||||0.4464
70862026|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.0511|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being Final Score||||0.0511
70862027|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final Score||||0.0002
70862028|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.0296|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning Final Score||||0.0296
71134282|NCT03152591|141771245|OTHER||Ratio LIK066/Placebo|0.79||||0.204|TWO_SIDED|90.0|0.58|1.08|||t-test, 2 sided|Two-sided test at the 0.1 significance level|Values \< LLOQ and values \> ULOQ are imputed as LLOQ/2 and ULOQ respectively.||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|1.08|0.58|0.204
70862029|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.3115|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects Final Score||||0.3115
70862030|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry Final Score||||0.0270
70862031|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life Final Score||||0.0008
70862032|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.0683|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total Score||||0.0683
71134283|NCT03868254|141771278|OTHER||||||<|0.0001|||||||Paired t-test|||||||<.0001
70862033|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.2226|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final Score||||0.2226
70862034|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.0823|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being Final Score||||0.0823
70862035|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.1459|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final Score||||0.1459
70862036|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.261|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning Final Score||||0.2610
70862037|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.9119|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||||||0.9119
70862038|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.0826|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry Final Score||||0.0826
70862039|NCT01325623|141210428|SUPERIORITY_OR_OTHER|||||||0.0036|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life Final Score||||0.0036
70862040|NCT02694523|141210435|OTHER||difference in percentage of participants|24.9|||<|0.001|TWO_SIDED|95.0|17.5|32.4|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to tumor necrosis factor (TNF) antagonists (0 vs ≥1).||32.4|17.5|<0.001
70862041|NCT02694523|141210436|OTHER||difference in percentage of participants|23.3|||<|0.001|TWO_SIDED|95.0|16.6|30.1|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||30.1|16.6|<0.001
70862042|NCT02694523|141210437|OTHER||difference in percentage of participants|45.0|||<|0.001|TWO_SIDED|95.0|28.9|61.1|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||61.1|28.9|<0.001
71134284|NCT03868254|141771278|OTHER||||||<|0.0001|||||||Paired t-test|||||||<.0001
71134285|NCT03868254|141771279|OTHER||||||<|0.0001|||||||Paired t-test|||||||<.0001
70862043|NCT02694523|141210438|OTHER||difference in percentage of participants|18.9|||<|0.001|TWO_SIDED|95.0|13.0|24.9|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||24.9|13.0|<0.001
70862044|NCT02694523|141210439|OTHER||difference in percentage of participants|16.7|||<|0.001|TWO_SIDED|95.0|9.5|23.9|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||23.9|9.5|<0.001
71134286|NCT03868254|141771279|OTHER|||||||0.0001|||||||Paired t-test|||||||0.0001
70862045|NCT02694523|141210440|OTHER||difference in percentage of participants|32.8|||<|0.001|TWO_SIDED|95.0|18.8|46.9|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||46.9|18.8|<0.001
70862046|NCT02694523|141210441|OTHER||difference in percentage of participants|32.8|||<|0.001|TWO_SIDED|95.0|18.8|46.9|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||46.9|18.8|<0.001
70862047|NCT02694523|141210442|OTHER||difference in percentage of participants|38.9|||<|0.001|TWO_SIDED|95.0|22.0|55.8|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||55.8|22.0|<0.001
70862048|NCT05896748|141210443|OTHER||Ratio of geometric least square mean|0.948|||||TWO_SIDED|90.0|0.901|0.998|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Ctau within CAB||0.998|0.901|
70862049|NCT05896748|141210443|OTHER||Ratio of geometric least square mean|0.935|||||TWO_SIDED|90.0|0.877|0.995|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Ctau within CAB||0.995|0.877|
70862050|NCT05896748|141210443|OTHER||Ratio of geometric least square mean|0.934|||||TWO_SIDED|90.0|0.872|1.0|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Ctau within CAB||1.000|0.872|
71134287|NCT03868254|141771280|OTHER|||||||0.003|||||||Paired t-test|||||||0.0030
70862051|NCT05896748|141210443|OTHER||Ratio of geometric least square mean|0.999|||||TWO_SIDED|90.0|0.943|1.059|||Mixed effect analysisofcovariance(ANCOVA|||To compare the IM gluteal injections for Ctau within CAB||1.059|0.943|
70862052|NCT05896748|141210444|OTHER||Ratio of geometric least square mean|1.002|||||TWO_SIDED|90.0|0.952|1.056|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Ctau within RPV||1.056|0.952|
70862053|NCT05896748|141210444|OTHER||Ratio of geometric least square mean|0.961|||||TWO_SIDED|90.0|0.921|1.002|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Ctau within RPV||1.002|0.921|
70862054|NCT05896748|141210444|OTHER||Ratio of geometric least square mean|0.928|||||TWO_SIDED|90.0|0.885|0.973|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Ctau within RPV||0.973|0.885|
70862055|NCT05896748|141210444|OTHER||Ratio of geometric least square mean|1.003|||||TWO_SIDED|90.0|0.955|1.053|||Mixed effect analysisofcovariance(ANCOVA|||To compare the IM gluteal injections for Ctau within RPV||1.053|0.955|
70862056|NCT05896748|141210445|OTHER||Ratio of geometric least square mean|0.942|||||TWO_SIDED|90.0|0.897|0.99|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Cmax within CAB||0.990|0.897|
70862057|NCT05896748|141210445|OTHER||Ratio of geometric least square mean|0.911|||||TWO_SIDED|90.0|0.86|0.965|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Cmax within CAB||0.965|0.860|
70862058|NCT05896748|141210445|OTHER||Ratio of geometric least square mean|0.91|||||TWO_SIDED|90.0|0.857|0.966|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Cmax within CAB||0.966|0.857|
70862059|NCT05896748|141210445|OTHER||Ratio of geometric least square mean|1.003|||||TWO_SIDED|90.0|0.938|1.074|||Mixed effect analysisofcovariance(ANCOVA|||To compare the IM gluteal injections for Cmax within CAB||1.074|0.938|
70862060|NCT05896748|141210446|OTHER||Ratio of geometric least square mean|0.938|||||TWO_SIDED|90.0|0.895|0.982|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Cmax within RPV||0.982|0.895|
70862061|NCT05896748|141210446|OTHER||Ratio of geometric least square mean|0.918|||||TWO_SIDED|90.0|0.876|0.963|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Cmax within RPV||0.963|0.876|
70862062|NCT05896748|141210446|OTHER||Ratio of geometric least square mean|0.905|||||TWO_SIDED|90.0|0.861|0.952|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Cmax within RPV||0.952|0.861|
70862063|NCT05896748|141210446|OTHER||Ratio of geometric least square mean|0.937|||||TWO_SIDED|90.0|0.891|0.986|||Mixed effect analysisofcovariance(ANCOVA|||To compare the IM gluteal injections for Cmax within RPV||0.986|0.891|
70862064|NCT05896748|141210447|OTHER||Ratio of geometric least square mean|0.944|||||TWO_SIDED|90.0|0.906|0.983|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within CAB||0.983|0.906|
70862065|NCT05896748|141210447|OTHER||Ratio of geometric least square mean|0.944|||||TWO_SIDED|90.0|0.895|0.995|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within CAB||0.995|0.895|
70862066|NCT05896748|141210447|OTHER||Ratio of geometric least square mean|0.933|||||TWO_SIDED|90.0|0.876|0.994|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within CAB||0.994|0.876|
70862067|NCT05896748|141210447|OTHER||Ratio of geometric least square mean|1.04|||||TWO_SIDED|90.0|0.979|1.105|||Mixed effect analysisofcovariance(ANCOVA|||To compare the IM gluteal injections for AUC\[0-tau\] within CAB||1.105|0.979|
71134288|NCT03868254|141771280|OTHER|||||||0.0018|||||||Paired t-test|||||||0.0018
71134289|NCT03868254|141771281|OTHER|||||||0.0053|||||||Paired t-test|||||||0.0053
71134290|NCT03868254|141771281|OTHER|||||||0.0472|||||||Paired t-test|||||||0.0472
71134291|NCT02848222|141771288|SUPERIORITY|||||||0.02||||||Threshold for significance was p \< 0.05|ANOVA|||||||0.02
70862068|NCT05896748|141210448|OTHER||Ratio of geometric least square mean|0.966|||||TWO_SIDED|90.0|0.932|1.002|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within RPV||1.002|0.932|
70862069|NCT05896748|141210448|OTHER||Ratio of geometric least square mean|0.955|||||TWO_SIDED|90.0|0.922|0.989|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within RPV||0.989|0.922|
70862070|NCT05896748|141210448|OTHER||Ratio of geometric least square mean|0.948|||||TWO_SIDED|90.0|0.907|0.991|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within RPV||0.991|0.907|
70862071|NCT05896748|141210448|OTHER||Ratio of geometric least square mean|1.014|||||TWO_SIDED|90.0|0.972|1.058|||Mixed effect analysisofcovariance(ANCOVA|||To compare the IM gluteal injections for AUC\[0-tau\] within RPV||1.058|0.972|
70862072|NCT04010539|141210505|NON_INFERIORITY|The difference in microbiological success rates between treatment groups (Gepotidacin - Ceftriaxone plus azithromycin) was calculated using the Miettinen-Nurminen Summary Score Method adjusted for sex and sexual orientation combination. Non-inferiority was declared if the lower limit of the 2-sided 95% confidence interval for the difference was above -10.0%.|Adjusted Difference in Percent|-0.1|||||TWO_SIDED|95.0|-5.6|5.5||||||||5.5|-5.6|
70862073|NCT04010539|141210505|SUPERIORITY|The difference in microbiological success rates between treatment groups (Gepotidacin - Ceftriaxone plus azithromycin) was calculated using the Miettinen-Nurminen Summary Score Method adjusted for sex and sexual orientation combination. Superiority was declared if the lower limit of the 2-sided 95% confidence interval for the difference was above 0.0%.|Adjusted Difference in Percent|-0.1||||0.5072|TWO_SIDED|95.0|-5.6|5.5|||1-sided p-value for Test of Superiority|||||5.5|-5.6|0.5072
70862074|NCT04231318|141210540|SUPERIORITY|||||||0.0406|||||||ANOVA|||||||0.0406
70862075|NCT04231318|141210540|SUPERIORITY|||||||0.0795|||||||ANOVA|||||||0.0795
70862076|NCT04231318|141210540|SUPERIORITY|||||||0.7601|||||||ANOVA|||||||0.7601
70862077|NCT04231318|141210541|SUPERIORITY|||||||0.1942|||||||ANOVA|||||||0.1942
70862078|NCT04231318|141210541|SUPERIORITY|||||||0.0957|||||||ANOVA|||||||0.0957
70862079|NCT04231318|141210541|SUPERIORITY|||||||0.4526|||||||ANOVA|||||||0.4526
70862080|NCT04231318|141210542|SUPERIORITY|||||||0.1309|||||||ANOVA|||||||0.1309
70862081|NCT04231318|141210542|SUPERIORITY|||||||0.17|||||||ANOVA|||||||0.1700
70862082|NCT04231318|141210542|SUPERIORITY|||||||0.7609|||||||ANOVA|||||||0.7609
70862083|NCT04231318|141210543|SUPERIORITY|||||||0.1|||||||ANOVA|||||||0.1000
70862084|NCT04231318|141210543|SUPERIORITY|||||||0.0423|||||||ANOVA|||||||0.0423
70862085|NCT04231318|141210543|SUPERIORITY|||||||0.383|||||||ANOVA|||||||0.3830
70862086|NCT04231318|141210544|SUPERIORITY|||||||0.0298|||||||ANOVA|||||||0.0298
70862087|NCT04231318|141210544|SUPERIORITY|||||||0.0217|||||||ANOVA|||||||0.0217
70862088|NCT04231318|141210544|SUPERIORITY|||||||0.4451|||||||ANOVA|||||||0.4451
70862089|NCT04231318|141210545|SUPERIORITY|||||||0.1197|||||||ANOVA|||||||0.1197
70862090|NCT04231318|141210545|SUPERIORITY|||||||0.0008|||||||ANOVA|||||||0.0008
70862091|NCT04231318|141210545|SUPERIORITY|||||||0.0223|||||||ANOVA|||||||0.0223
70862092|NCT04231318|141210546|SUPERIORITY|||||||0.1067|||||||ANOVA|||||||0.1067
70862093|NCT04231318|141210547|SUPERIORITY|||||||0.1715|||||||ANOVA|||||||0.1715
70862094|NCT04231318|141210547|SUPERIORITY|||||||0.0736|||||||ANOVA|||||||0.0736
70862095|NCT04231318|141210547|SUPERIORITY|||||||0.4098|||||||ANOVA|||||||0.4098
70862096|NCT04231318|141210548|SUPERIORITY|||||||0.2718|||||||ANOVA|||||||0.2718
70862097|NCT04231318|141210548|SUPERIORITY|||||||0.0182|||||||ANOVA|||||||0.0182
70862098|NCT04231318|141210548|SUPERIORITY|||||||0.1131|||||||ANOVA|||||||0.1131
70862099|NCT04231318|141210549|SUPERIORITY|||||||0.2143|||||||ANOVA|||||||0.2143
70862100|NCT04231318|141210549|SUPERIORITY|||||||0.1628|||||||ANOVA|||||||0.1628
70862101|NCT04231318|141210549|SUPERIORITY|||||||0.6036|||||||ANOVA|||||||0.6036
70862102|NCT04231318|141210550|SUPERIORITY|||||||0.222|||||||ANOVA|||||||0.2220
70862103|NCT04231318|141210550|SUPERIORITY|||||||0.141|||||||ANOVA|||||||0.1410
70862104|NCT04231318|141210550|SUPERIORITY|||||||0.5418|||||||ANOVA|||||||0.5418
70862105|NCT04231318|141210551|SUPERIORITY|||||||0.1619|||||||ANOVA|||||||0.1619
70862106|NCT04231318|141210551|SUPERIORITY|||||||0.1683|||||||ANOVA|||||||0.1683
70862107|NCT04231318|141210551|SUPERIORITY|||||||0.6969|||||||ANOVA|||||||0.6969
70862108|NCT04231318|141210552|SUPERIORITY|||||||0.0701|||||||ANOVA|||||||0.0701
70862109|NCT04231318|141210552|SUPERIORITY|||||||0.0925|||||||ANOVA|||||||0.0925
70862110|NCT04231318|141210552|SUPERIORITY|||||||0.6981|||||||ANOVA|||||||0.6981
70862111|NCT04231318|141210553|SUPERIORITY|||||||0.0275|||||||ANOVA|||||||0.0275
70862112|NCT04231318|141210553|SUPERIORITY|||||||0.1738|||||||ANOVA|||||||0.1738
70862113|NCT04231318|141210553|SUPERIORITY|||||||0.8364|||||||ANOVA|||||||0.8364
70862114|NCT04231318|141210554|SUPERIORITY|||||||0.2227|||||||ANOVA|||||||0.2227
70862115|NCT04231318|141210554|SUPERIORITY|||||||0.1114|||||||ANOVA|||||||0.1114
70862116|NCT04231318|141210554|SUPERIORITY|||||||0.4635|||||||ANOVA|||||||0.4635
70862117|NCT05298306|141210574|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.25||||0.5196|TWO_SIDED|95.0|-1.02|0.52||No adjustment for multiple comparisons was made due to the exploratory nature of the study|Mixed Models Analysis||Difference is LAT8881 minus placebo|Change from baseline VAS score at 0.25 hours||0.52|-1.02|0.5196
70862118|NCT05298306|141210574|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.32||||0.3983|TWO_SIDED|95.0|-1.09|0.44||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is LAT8881 minus placebo|Change in VAS score from baseline at 0.5 hours||0.44|-1.09|0.3983
70862119|NCT05298306|141210574|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.26||||0.489|TWO_SIDED|95.0|-1.03|0.5||No adjustment for multiple comparisons was made due to the exploratory nature of the study|Mixed Models Analysis||Difference is LAT8881 minus placebo|Change from baseline VAS score at 0.75 hours||0.5|-1.03|0.4890
70862120|NCT05298306|141210574|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.21||||0.5903|TWO_SIDED|95.0|-0.97|0.56||No adjustment for multiple comparisons was made due to the exploratory nature of the study|Mixed Models Analysis||Difference is LAT8881 minus placebo|Change from baseline VAS score at 1 hour||0.56|-0.97|0.5903
70862121|NCT05298306|141210574|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.13||||0.7352|TWO_SIDED|95.0|-0.9|0.64||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 1.5 hours||0.64|-0.90|0.7352
70862122|NCT05298306|141210574|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.15||||0.6892|TWO_SIDED|95.0|-0.92|0.61||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 2 hours||0.61|-0.92|0.6892
70862123|NCT05298306|141210574|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.01||||0.9767|TWO_SIDED|95.0|-0.78|0.76||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 2.5 hours||0.76|-0.78|0.9767
70862124|NCT05298306|141210574|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Median Difference (Net)|0.32||||0.3964|TWO_SIDED|95.0|-0.44|1.09||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 3 hours||1.09|-0.44|0.3964
70862125|NCT05298306|141210574|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|0.22||||0.5669|TWO_SIDED|95.0|-0.55|0.98||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 3.5 hours||0.98|-0.55|0.5669
70862126|NCT05298306|141210574|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.15||||0.7006|TWO_SIDED|95.0|-0.91|0.62||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 4 hours||0.62|-0.91|0.7006
70862127|NCT05298306|141210574|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.1||||0.794|TWO_SIDED|95.0|-0.87|0.67||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 5 hours||0.67|-0.87|0.7940
70862128|NCT05298306|141210574|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.15||||0.6892|TWO_SIDED|95.0|-0.92|0.61|||Mixed Models Analysis|No adjustment for multiple comparisons was made due to the exploratory nature of the study.||Change from baseline VAS score at 6 hours|Difference is LAT8881 minus placebo.|0.61|-0.92|0.6892
70862129|NCT00620464|141210585|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||90.0||||Applies to all parameters.|Bioequivalence Testing|||||||0.05
70862130|NCT00620464|141210586|SUPERIORITY_OR_OTHER_LEGACY||||||<=|0.05||95.0|||||Bioequivalence Testing|||||||<=0.05
71134292|NCT00797277|141771292|NON_INFERIORITY_OR_EQUIVALENCE|There was no previous study comparing these 2 treatments. We hypothesized that the mean difference between the 2 treatments would be small.|Mean Difference (Final Values)|1.0|||<|0.05|||||||t-test, 2 sided|||we hypothesized that there would be no statistical significant difference between the 2 groups in the primary outcome.||||<0.05
71134293|NCT03187132|141771298|SUPERIORITY||Mean Difference (Final Values)|-1.86|STANDARD_ERROR_OF_MEAN|1.17||0.111|TWO_SIDED|95.0|-4.15|0.43|||Mixed Models Analysis||The estimate is for the Digital Pain Reduction Kit arm.|We used a repeated measures linear mixed model featuring fixed effects for time, study arm, and score at week 1, and random effects to account for within subject variation.||.43|-4.15|.111
70862131|NCT01842815|141210605|SUPERIORITY|||||||0.0077||||||The value looked at for statistical significance is if p\<.05.|t-test, 2 sided|t-tailed, paired t-test||This t-test is to test the statistical significance of the right side of the tattoo clearance vs. the left side of the tattoo clearance. It tests if there is a difference between the tattoo being treated twice per visit (right side) vs. being treated once per visit (left side).||||.0077
70862132|NCT01842815|141210606|SUPERIORITY|||||||0.00012||||||The value looked at for statistical significance is if p\<.05.|t-test, 2 sided|t-tailed, paired t-test||This t-test is to test the statistical significance of the right side of the tattoo clearance vs. the left side of the tattoo clearance. It tests if there is a difference between the tattoo being treated twice per visit (right side) vs. being treated once per visit (left side).||||.00012
70862133|NCT01842815|141210607|SUPERIORITY|||||||0.0034||||||The value looked at for statistical significance is if p\<.05.|t-test, 2 sided|t-tailed, paired t-test||This t-test is to test the statistical significance of the right side of the tattoo clearance vs. the left side of the tattoo clearance. It tests if there is a difference between the tattoo being treated twice per visit (right side) vs. being treated once per visit (left side).||||.0034
70862134|NCT00252629|141210626|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||t-test, 2 sided|||The change of fatigue complaint from baseline (before treatment) to post treatment ( after 3 weeks treatment) on either therapeutic CPAP or sham CPAP was compared with student t-test.||||0.0002
70862135|NCT00252629|141210627|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||t-test, 2 sided|||The change of pain symptom from baseline (before treatment) to post treatment ( after 3 weeks treatment) on either therapeutic CPAP or sham CPAP was compared with student t-test.||||0.0008
70862136|NCT00252629|141210628|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||The change of cognitive dysfunction complaint from baseline (before treatment) to post treatment ( after 3 weeks treatment) on either therapeutic CPAP or sham CPAP was compared with student t-test.||||0.004
70862137|NCT00252629|141210629|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||t-test, 2 sided|||The p value was based on t-test||||0.0001
71134294|NCT03187132|141771299|SUPERIORITY||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|1.27||0.612|TWO_SIDED|95.0|-1.84|3.12|||Mixed Models Analysis||The estimate is for the Digital Pain Reduction Kit arm.|We used a repeated measures linear mixed model featuring fixed effects for time, study arm, and score at week 1, and random effects to account for within subject variation.||3.12|-1.84|.612
70862138|NCT00667602|141210641|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC)|Percentage Difference|-8.0|||||TWO_SIDED|95.0|-15.0|-1.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||The primary criterion for immunogenicity was that the lower limit of the two-sided 95% confidence interval (CI) for the difference between one dose of MenACWY-CRM197 and MenC in the percentage of subjects with hSBA ≥1:8 for serogroup C at 1 month following the 12 months vaccination was greater than -10% .||-1|-15|
70862139|NCT00667602|141210642|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC)|Percentage difference|-7.0|||||TWO_SIDED|95.0|-13.0|-2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||The primary criterion for immunogenicity was that the lower limit of the two-sided 95% confidence interval (CI) for the difference between one dose of MenACWY-CRM197 and MenC in the percentage of subjects with hSBA ≥ 1:4 for serogroup C at 1 month following the 12 months vaccination was greater than -10%.||-2|-13|
70862140|NCT00667602|141210643|NON_INFERIORITY_OR_EQUIVALENCE|(PMenACWY - PMenC \> -10%).|Mean Difference (Final Values)|72.0|||||TWO_SIDED|95.0|64.0|79.0|||Percentage difference|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:8, prevaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than -10%.||79|64|
70862141|NCT00667602|141210643|NON_INFERIORITY_OR_EQUIVALENCE|(PMenACWY - PMenC \> -10%).|Mean Difference (Net)|7.0|||||TWO_SIDED|95.0|3.0|13.0|||Percentage difference|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:8, one month postvaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than -10%.||13|3|
70862142|NCT00667602|141210643|NON_INFERIORITY_OR_EQUIVALENCE|(PMenACWY - PMenC \> -10%).|Mean Difference (Final Values)|80.0|||||TWO_SIDED|95.0|73.0|86.0|||Percentage difference|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:4, prevaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than -10%.||86|73|
70862143|NCT00667602|141210643|NON_INFERIORITY_OR_EQUIVALENCE|(PMenACWY - PMenC \> -10%).|Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.0|5.0|||Percentage difference|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:4, one month postvaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than -10%.||5|-2|
71134295|NCT03187132|141771300|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|2.58||0.87|TWO_SIDED|95.0|-5.51|4.66|||t-test, 2 sided|||For work productivity measures, self-reported opioid utilization, and post-study measures of satisfaction, we used t-tests for normally distributed data and Wilcoxon Rank-Sum tests for non-normally distributed data.||4.66|-5.51|.87
71134296|NCT03187132|141771300|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.274||0.787|TWO_SIDED|95.0|-0.54|0.54|||t-test, 2 sided|||For work productivity measures, self-reported opioid utilization, and post-study measures of satisfaction, we used t-tests for normally distributed data and Wilcoxon Rank-Sum tests for non-normally distributed data.||.54|-.54|.787
70862144|NCT00667602|141210645|NON_INFERIORITY_OR_EQUIVALENCE|(GMTMenACWY/GMTMenC \> 0.5).|Ratio|0.92|||||TWO_SIDED|95.0|0.76|1.12|||ANOVA|||For comparison of the Geometric Mean Titers, prevaccination at 12 months of age, MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the 2-sided 95% CI for the ratio of the MenACWY-CRM197 to MenC Geometric Mean Titers for serogroup C was greater than 0.5.||1.12|0.76|
70862145|NCT00667602|141210645|NON_INFERIORITY_OR_EQUIVALENCE|(GMTMenACWY/GMTMenC \> 0.5).|Ratio|0.73|||||TWO_SIDED|95.0|0.57|0.93|||ANOVA|||For comparison of the Geometric Mean Titers, one month postvaccination at 12 months of age, MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the 2-sided 95% CI for the ratio of the MenACWY-CRM197 to MenC Geometric Mean Titers for serogroup C was greater than 0.5.||0.93|0.57|
70862146|NCT00667602|141210647|NON_INFERIORITY_OR_EQUIVALENCE|(GMTMenACWY/GMTMenjugate \> 0.5).|Ratio|10.0|||||TWO_SIDED|95.0|8.43|13.0|||ANOVA|||For comparison of the GMTs (prevaccination), MenACWY was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the ratio of the MenACWY to MenC GMTs for serogroup C was greater than 0.5 .||13|8.43|
70862147|NCT00667602|141210647|NON_INFERIORITY_OR_EQUIVALENCE|(GMTMenACWY/GMTMenjugate \> 0.5).|Ratio|8.1|||||TWO_SIDED|95.0|6.35|10.0|||ANOVA|||For comparison of the GMTs (one month postvaccination), MenACWY was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the ratio of the MenACWY to MenC GMTs for serogroup C was greater than 0.5.||10|6.35|
70862148|NCT00667602|141210648|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥0.1 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-2|
70862149|NCT00667602|141210648|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥0.1 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-2|
70862150|NCT00667602|141210648|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|1.0|||||TWO_SIDED|95.0|-3.0|5.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥1.0 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||5|-3|
70862151|NCT00667602|141210648|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-3.0|4.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥1.0 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||4|-3|
70954374|NCT03568318|141411399|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|37.2|||<|0.001|TWO_SIDED|95.0|31.0|43.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||43.3|31.0|<0.001
70862152|NCT00667602|141210648|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 0.1 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-2|
70862153|NCT00667602|141210648|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 0.1 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, for any of the antigens, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-2|
70872145|NCT00429273|141229566|OTHER|Test for differences in treatment outcomes between three different tx|F-Value for variance component|18.9|||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||Analyses are based on a generalized linear mixed model (GLMM) modelling the effects of the medication when calibrated to optimal dosage and controlling for time effects and within-subject effects. The design is a combined within-between subject design, where each participant is exposed to, and provides information about multiple tx modalities.||||<.01
71134297|NCT03187132|141771300|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.34||0.569|TWO_SIDED|95.0|-0.88|0.48|||t-test, 2 sided|||For work productivity measures, self-reported opioid utilization, and post-study measures of satisfaction, we used t-tests for normally distributed data and Wilcoxon Rank-Sum tests for non-normally distributed data.||.48|-.88|.569
71134298|NCT03187132|141771301|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.09||0.467|TWO_SIDED|95.0|-0.23|0.49|||t-test, 2 sided|||For work productivity measures, self-reported opioid utilization, and post-study measures of satisfaction, we used t-tests for normally distributed data and Wilcoxon Rank-Sum tests for non-normally distributed data.||.49|-.23|.467
71134299|NCT03187132|141771302|SUPERIORITY||Odds Ratio (OR)|0.79|STANDARD_ERROR_OF_MEAN|0.986||0.852|TWO_SIDED|95.0|0.07|9.07|||Regression, Logistic|||We used a multilevel logistic regression with random effects at the individual level and fixed effects for week and study-arm.||9.07|.07|.852
71134300|NCT03594773|141771303|SUPERIORITY||Mean Difference (Final Values)|-0.496|STANDARD_ERROR_OF_MEAN|1.56||0.752|TWO_SIDED|95.0|-3.62|2.63|||t-test, 2 sided|df=56, equal variances assumed||||2.63|-3.62|.752
71134301|NCT03594773|141771304|SUPERIORITY||Mean Difference (Final Values)|1.26|STANDARD_ERROR_OF_MEAN|2.62||0.633|TWO_SIDED|95.0|-4.01|6.52|||t-test, 2 sided|df=49, equal variances assumed||||6.52|-4.01|.633
71134302|NCT03594773|141771305|SUPERIORITY||Mean Difference (Final Values)|0.95|STANDARD_ERROR_OF_MEAN|1.73||0.586|TWO_SIDED|95.0|-2.53|4.44|||t-test, 2 sided|df=49, equal variances assumed||||4.44|-2.53|.586
71134303|NCT00991939|141771322|SUPERIORITY_OR_OTHER||Difference of proportions|0.0|STANDARD_ERROR_OF_MEAN|0.58||1|TWO_SIDED|95.0|-0.975|0.708|||Fisher Exact||The estimated value is the proportion of success in the high dose pulse dexamethasone group minus the proportion of success in the standard prednisone group.|Four subjects were not included in this analysis because not enough data was available to assess the primary outcome at the time the study was terminated.||0.708|-0.975|1.00
71134304|NCT01100320|141771377|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|99.9|||||TWO_SIDED|90.0|95.4|104.52|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||104.52|95.40|
71134305|NCT01100320|141771378|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|92.6|||||TWO_SIDED|90.0|90.11|95.09|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||95.09|90.11|
71134306|NCT01100320|141771379|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|92.6|||||TWO_SIDED|90.0|90.13|95.13|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||95.13|90.13|
71134307|NCT01369784|141771430|SUPERIORITY_OR_OTHER|||||||0.812|||||||Fisher Exact|||||||0.812
71134308|NCT01369784|141771431|SUPERIORITY_OR_OTHER|||||||0.612|||||||Chi-squared|||||||0.612
71134309|NCT01369784|141771432|SUPERIORITY_OR_OTHER|||||||0.402|||||||Chi-squared|||||||0.402
71134310|NCT01369784|141771433|SUPERIORITY_OR_OTHER|||||||0.557|||||||Chi-squared|||||||0.557
71134311|NCT01369784|141771434|SUPERIORITY_OR_OTHER|||||||0.234|||||||Chi-squared|||||||0.234
71134312|NCT01369784|141771435|SUPERIORITY_OR_OTHER|||||||0.057|||||||Fisher Exact|||||||0.057
71134313|NCT01369784|141771436|SUPERIORITY_OR_OTHER|||||||0.117|||||||Fisher Exact|||||||0.117
71134314|NCT00596752|141771441|SUPERIORITY_OR_OTHER|||||||0.2587||||||For confirmatory hypothesis testing the p-values of the normal approximation test for comparing two rates was used as input for the weighted inverse normal method. The 1-sided boundary p-value for stage 1 is given by p1=0.00587.|Cochran-Mantel-Haenszel|The 2 primary endpoints were tested at one-sided 0.0125 each so that the overall type I error rate of 0.025 was controlled in a strong sense.||"Primary goal was to test the following null hypothesis:~H01: πhealingPGE1≤ πhealingPlacebo, with πhealing=proportion of subjects with complete ulcer healing. The planned information rate for stage 1 of the two-stage group sequential test design with an overall one-sided comparison-wise α=0.0125 for this co-primary endpoint is given by 0.83.~This is the statistical analysis of stage 1."||||0.2587
71134315|NCT00596752|141771441|SUPERIORITY_OR_OTHER|||||||0.3463||||||For confirmatory hypothesis testing the p-values of the normal approximation test for comparing two rates was used as input for the weighted inverse normal method. The 1-sided boundary p-value for stage 1 and 2 combined is given by p2=0.01085.|Cochran-Mantel-Haenszel|The 2 primary endpoints were tested at one-sided 0.0125 each so that the overall type I error rate of 0.025 was controlled in a strong sense.||"Primary goal was to test the following null hypothesis:~H01: πhealingPGE1≤ πhealingPlacebo, with πhealing=proportion of subjects with complete ulcer healing.~This is the statistical analysis of stage 1 and stage 2 combined."||||0.3463
71134316|NCT00596752|141771442|SUPERIORITY_OR_OTHER|||||||0.0173||||||For confirmatory hypothesis testing the p-values of the normal approximation test for comparing two rates was used as input for the weighted inverse normal method. The 1-sided boundary p-value for stage 1 is given by p1=0.00587.|Cochran-Mantel-Haenszel|The 2 primary endpoints were tested at one-sided 0.0125 each so that the overall type I error rate of 0.025 was controlled in a strong sense.||"Primary goal was to test the following null hypothesis:~H02: πampPGE1≥ πampPlacebo, with πamp=proportion of subjects with major amputations.~The planned information rate for stage 1 of the two-stage group sequential test design with an overall one-sided comparison-wise α=0.0125 for this co-primary endpoint is given by 0.83.~This is the statistical analysis of stage 1."||||0.0173
71134317|NCT00596752|141771442|SUPERIORITY_OR_OTHER|||||||0.1154||||||For confirmatory hypothesis testing the p-values of the normal approximation test for comparing two rates was used as input for the weighted inverse normal method. The 1-sided boundary p-value for stage 1 and 2 combined is given by p2=0.01085.|Cochran-Mantel-Haenszel|The 2 primary endpoints were tested at one-sided 0.0125 each so that the overall type I error rate of 0.025 was controlled in a strong sense.||"Primary goal was to test the following null hypothesis:~H02: πampPGE1≥ πampPlacebo, with πamp=proportion of subjects with major amputations.~This is the statistical analysis of stage 1 and stage 2 combined."||||0.1154
71134318|NCT03884790|141771463|OTHER|Descriptive statistical analysis|||||||||||||||||Descriptive statistical analysis|||
71134319|NCT04378270|141771470|OTHER||Mean Difference (Final Values)|2.93|STANDARD_ERROR_OF_MEAN|1.61||0.0796|TWO_SIDED|95.0|-0.3687|6.2287|||t-test, 2 sided|Degrees of Freedom (DF)- 28||This procedure calculates the difference between the observed means in two independent samples (two collected assessment timepoints, screening and 4 week follow up visits). A significance value (P-value) and 95% Confidence Interval (CI) of the difference is reported. The P-value is the probability of obtaining the observed difference between the samples if the null hypothesis were true. The null hypothesis is the hypothesis that the difference is 0.||6.2287|-0.3687|0.0796
71134320|NCT04378270|141771471|OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.879||0.0634|TWO_SIDED|95.0|-3.5014|0.1014|||t-test, 2 sided|Degrees of Freedom (DF)- 28||This procedure calculates the difference between the observed means in two independent samples (two collected assessment timepoints, screening and 4 week follow up visits). A significance value (P-value) and 95% Confidence Interval (CI) of the difference is reported. The P-value is the probability of obtaining the observed difference between the samples if the null hypothesis were true. The null hypothesis is the hypothesis that the difference is 0.||0.1014|-3.5014|0.0634
71134321|NCT04378270|141771472|OTHER||Mean Difference (Final Values)|18.7|STANDARD_ERROR_OF_MEAN|5.492||0.002|TWO_SIDED|95.0|7.4498|29.9502|||t-test, 2 sided|Degrees of Freedom (DF)- 28||This procedure calculates the difference between the observed means in two independent samples (two collected assessment timepoints, screening and 4 week follow up visits). A significance value (P-value) and 95% confidence interval (CI) of the difference is reported. The P value is the probability of obtaining the observed difference between the samples if the null hypothesis were true. The null hypothesis is the hypothesis that the difference is 0.||29.9502|7.4498|0.0020
71134322|NCT04378270|141771473|OTHER||Mean Difference (Net)|16.67|STANDARD_ERROR_OF_MEAN|4.327||0.0006|TWO_SIDED|95.0|7.8069|25.5331|||t-test, 2 sided|Degrees of freedom (DF)- 28||||25.5331|7.8069|0.0006
71134323|NCT04378270|141771476|OTHER||Mean pain scale|17.87|STANDARD_DEVIATION|2.39||0.0001|TWO_SIDED|95.0|16.5465|19.1935|||t-test, 2 sided|Degrees of freedom (DF)- 14||This procedure calculates the difference of an observed mean (from the assessment collected at the 4 week visit) with a hypothesized mean value (10, a mid level scale score). A significance value (P-value) and 95% Confidence Interval (CI) of the observed mean is reported. The P-value is the probability of obtaining the observed mean in the sample if the null hypothesis value were the true value.||19.1935|16.5465|0.0001
71134324|NCT03838978|141771482|SUPERIORITY|Non-inferiority is demonstrated if the 90% LB \> -10.0%. If non-inferiority was met, superiority could be tested. Superiority is demonstrated if 97.5% LB \> 0.0%.||||||||||||||||For missing data in both Arms/Groups, multiple imputation was performed for the primary CCS analysis.|Device group differences and two-sided 90% and 97.5% confidence interval lower bounds (LB) adjusting for propensity score (PS) subclass based on PS subclass weights (ATT). Noninferiority is demonstrated if the 90% LB \> -10.0%. Superiority is demonstrated if 97.5% LB \>0.0%. Two-sided 97.5% LB is evaluated rather than two-sided 95.0% LB since the superiority type 1 error is split between testing superiority in terms of Month 24 CCS and then separately for a set of superiority secondary endpoints with type 1 error control maintained through the use of Hochberg approach (following demonstration of non-inferiority).|||
71134325|NCT02119663|141771508|OTHER||Hazard Ratio (HR)|1.584|||||TWO_SIDED|95.0|0.886|2.83||||||||2.830|0.886|
71134326|NCT00892775|141771514|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for measles 42-56 days after vaccination was concluded if the lower limit of the 95% confidence interval around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|-0.64|||||TWO_SIDED|95.0|-2.29|1.76||||||||1.76|-2.29|
70862154|NCT00667602|141210648|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-2.0|||||TWO_SIDED|95.0|-6.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 1.0 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-6|
70862155|NCT00667602|141210648|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-1.0|||||TWO_SIDED|95.0|-6.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 1.0 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-6|
70862156|NCT00667602|141210648|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (polio 1, one month postvaccination), given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||4|-2|
70862157|NCT00667602|141210648|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (polio 1, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||4|-2|
70862158|NCT00667602|141210648|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (polio 2, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-2|
70862159|NCT00667602|141210648|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (polio 2, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-3|
70862160|NCT00667602|141210648|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (polio 3, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-3|
70862161|NCT00667602|141210648|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|0.0|||||TWO_SIDED|95.0|-2.0|3.0||Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.|Miettinen and Nurminen|||Immunogenicity of DTPa-IPV-HepB-Hib (Polio 3, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-2|
70862162|NCT00667602|141210648|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0||Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.|Miettinen and Nurminen|||Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 0.15 μg/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-2|
71134327|NCT00892775|141771514|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for mumps 42-56 days after vaccination was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|-0.74|||||TWO_SIDED|95.0|-6.14|5.58||||||||5.58|-6.14|
71134328|NCT00892775|141771514|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for rubella 42-56 days after vaccination was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|-0.32|||||TWO_SIDED|95.0|-1.78|2.08||||||||2.08|-1.78|
71134329|NCT00892775|141771514|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for varicella 42-56 days after vaccination was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|4.69|||||TWO_SIDED|95.0|0.72|10.34||||||||10.34|0.72|
71134330|NCT00699660|141771524|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Comparison of CAPS/WHODAS vs Nonstructured Interview study arms: linear and logistic mixed effects regression with clinical examiner stratified by study group as a random effect and study group as a fixed effect.|Regression, Linear|Covariates included experience, use of template,tests,reviewing records,age,education, study site,reviewer, and expert reviewer by group interaction.||Our sample size calculation yielded 466 for a power of 0.80 to detect a 10% absolute difference in sensitivity and adjusted for intraclass correlation. The number of covariates in regression models was limited to ensure the effective sample size remained ten times greater than the degrees of freedom in the model.||||<.001
71134331|NCT00699660|141771525|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Regression, Logistic|||||||<.01
71134332|NCT00699660|141771526|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Descriptive statistics on mean and standard deviation.|t-test, 2 sided|||||||>.05
71134333|NCT00699660|141771527|SUPERIORITY_OR_OTHER||Slope|47.3|STANDARD_ERROR_OF_MEAN|18.86||0.012|TWO_SIDED|||||0.05 level based on a two tailed test.|Regression, Linear|Covariates included years of experience, use of template, use of tests, age, education, study site.||Estimates of the influence on total time and tests of statistical significance were derived from multilevel mixed-effects linear regression (xtmixed in Stata)||||.012
71134334|NCT00064792|141771528|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||The primary outcome variable will be the serum cholesterol/total sterol ratio.||||0.002
71134335|NCT00064792|141771529|SUPERIORITY_OR_OTHER|||||||0.22|||||||t-test, 2 sided|||||||0.22
71134336|NCT01973413|141771562|NON_INFERIORITY_OR_EQUIVALENCE|Significance level of 0.05, 90% power, required 48 nights of OCL and 48 control nights to detect a 20% improvement.|||||=|0.037|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||=0.037
71134337|NCT01973413|141771563|SUPERIORITY_OR_OTHER||||||=|0.34|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||=0.340
71134338|NCT01773187|141771603|SUPERIORITY|||||||0.0003|||||||Fisher Exact|||Pre-specified||||0.0003
71134339|NCT01773187|141771604|SUPERIORITY|||||||0.2368|||||||Fisher Exact|||Pre-specified||||0.2368
71134340|NCT00291486|141771639|SUPERIORITY|||||||0.144|||||||t-test, 1 sided|||Comparison of CL between initial infusion and therapy infusion||||0.144
71134341|NCT00291486|141771640|SUPERIORITY|||||||0.361|||||||ANOVA|||||||0.361
71134342|NCT01099397|141771645|SUPERIORITY_OR_OTHER|||||||0.41||||||P-value at baseline|McNemar|McNemar was used at each of three time points to compare prediabetes diagnosis by fasting versus 2-hour OGTT||p\<0.05 was considered significant at baseline; the null hypothesis was that there was no difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose), the alternative hypothesis was that there was a significant difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose)||||0.41
71134343|NCT01099397|141771645|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||P-value at 9 weeks|McNemar|McNemar was used at each of three time points to compare prediabetes diagnosis by fasting versus 2-hour OGTT||p\<0.05 was considered significant at 9 week assessment; the null hypothesis was that there was no difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose), the alternative hypothesis was that there was a significant difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose)||||0.59
71134344|NCT01099397|141771645|SUPERIORITY_OR_OTHER|||||||0.41||95.0||||P-value at 18 weeks|McNemar|McNemar was used at each of three time points to compare prediabetes diagnosis by fasting versus 2-hour OGTT||p\<0.05 was considered significant at 18 week assessment; the null hypothesis was that there was no difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose), the alternative hypothesis was that there was a significant difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose)||||0.41
71134345|NCT03421106|141771646|SUPERIORITY||Mean Difference (Net)|2.53||||0.23|TWO_SIDED||||||Mixed Models Analysis|||||||0.23
71134346|NCT02663622|141771669|SUPERIORITY||Cox Proportional Hazard|0.13||||0.0274|TWO_SIDED|95.0|0.01|0.62|||Log Rank|Log-rank test stratified by the matched sets||A hazard ratio was calculated based on a Cox proportional hazards regression model with treatment as a factor using the robust sandwich covariance estimator, comparing the CD24Fc 960 mg arm to a matched control group consisting of 92 participants from the Center for International Blood and Marrow Transplant Research (CIBMTR) observational databases of clinical information on HCT, whose mean grade III-IV AGFS in days was 135.8 with an SD of 64.66.||0.62|0.01|0.0274
71134347|NCT02663622|141771670|SUPERIORITY||Cox Proportional Hazard|0.57||||0.0988|TWO_SIDED|95.0|0.3|1.08|||Log Rank|||A hazard ratio was calculated based on a Cox proportional hazards regression model with treatment as a factor using the robust sandwich covariance estimator, comparing the CD24Fc 960 mg arm to a matched control group consisting of 92 participants from the Center for International Blood and Marrow Transplant Research (CIBMTR) observational databases of clinical information on HCT, whose mean grade II-IV AGFS in days was 104.7 with an SD of 72.28.||1.08|0.30|0.0988
71134348|NCT02663622|141771676|SUPERIORITY||Cox Proportional Hazard|1.12||||0.9088|TWO_SIDED|95.0|0.43|2.88|||Log Rank|||A hazard ratio was calculated based on a Cox proportional hazards regression model with treatment as a factor using the robust sandwich covariance estimator, comparing the CD24Fc 960 mg arm to a matched control group consisting of 92 participants from the Center for International Blood and Marrow Transplant Research (CIBMTR) observational databases of clinical information on HCT, whose mean OS in days was 319.3 with an SD of 93.83.||2.88|0.43|0.9088
71134349|NCT02663622|141771678|SUPERIORITY||Cox Proportional Hazard|1.27||||0.6131|TWO_SIDED|95.0|0.66|2.46|||Log Rank|||A hazard ratio was calculated based on a Cox proportional hazards regression model with treatment as a factor using the robust sandwich covariance estimator, comparing the CD24Fc 960 mg arm to a matched control group consisting of 92 participants from the Center for International Blood and Marrow Transplant Research (CIBMTR) observational databases of clinical information on HCT, whose mean RFS in days was 296.0 with an SD of 115.32.||2.46|0.66|0.6131
71134350|NCT03678311|141771696|OTHER|The correlation between the outcome and AHI was tested by Spearman's correlation.|Spearman's correlation|0.13||||0.73|TWO_SIDED|95.0|-0.75|1.0|||Spearman's correlation|||Spearman's correlation was used to evaluate the relationship between the outcome and the apnea hypopnea index.||1.00|-0.75|0.73
71134351|NCT02936635|141771716|SUPERIORITY||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|3.619||0.2821|TWO_SIDED|95.0|-11.035|3.23|||Mixed Models Analysis|||||3.23|-11.035|0.2821
71134352|NCT02936635|141771717|SUPERIORITY||Median Difference (Final Values)|-5.32|STANDARD_ERROR_OF_MEAN|4.242||0.2118|TWO_SIDED|95.0|-13.711|3.067|||Mixed Models Analysis|||||3.067|-13.711|0.2118
70862163|NCT00667602|141210648|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 0.15 μg/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-2|
70862164|NCT00667602|141210648|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0||Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.|Miettinen and Nurminen|||Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 1.0 μg/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||4|-2|
70862165|NCT00667602|141210648|NON_INFERIORITY_OR_EQUIVALENCE|PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|-1.0|||||TWO_SIDED|95.0|-4.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 1.0 μg/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-4|
70862166|NCT00667602|141210648|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Hep B, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-3|
70862167|NCT00667602|141210648|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC)|Percentage Difference|-1.0|||||TWO_SIDED|95.0|-4.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Hep B, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-4|
70862168|NCT00667602|141210649|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-5.0|||||TWO_SIDED|95.0|-13.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC4, one month postvaccination)given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-13|
70862169|NCT00667602|141210649|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-6.0|||||TWO_SIDED|95.0|-12.0|-1.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7(PNC 6B, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||-1|-12|
70862170|NCT00667602|141210649|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|-5.0|||||TWO_SIDED|95.0|-11.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7(PnC 9V, one month postvaccination) given concomitantly with MenACWY-CRM197 or MenC was considered non-inferior, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than -10%.||2|-11|
70862171|NCT00667602|141210649|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC 14, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-3|
70862172|NCT00667602|141210649|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-10.0|||||TWO_SIDED|95.0|-19.0|-2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7( PNC 18C, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||-2|-19|
71134353|NCT02936635|141771718|SUPERIORITY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|1.205||0.6354|TWO_SIDED|95.0|-2.946|1.801|||Mixed Models Analysis|||||1.801|-2.946|0.6354
71134354|NCT02936635|141771719|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|1.509||0.8887|TWO_SIDED|95.0|-3.186|2.763|||Mixed Models Analysis|||||2.763|-3.186|0.8887
71134355|NCT03652181|141771734|EQUIVALENCE|The null hypothesis is that the year 1 change is equivalent to year 2 change in mean QSM||||||0.033|||||||t-test, 2 sided|||||||0.033
70862173|NCT00667602|141210649|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-10.0|||||TWO_SIDED|95.0|-17.0|-2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC 19F, one month postvaccination), given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||-2|-17|
70862174|NCT00667602|141210649|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-5.0|||||TWO_SIDED|95.0|-12.0|1.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC 23F, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||1|-12|
70862175|NCT00667602|141210649|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-5.0|||||TWO_SIDED|95.0|-12.0|4.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC4, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||4|-12|
70862176|NCT00667602|141210649|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-5.0|||||TWO_SIDED|95.0|-11.0|0.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC6B, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||0|-11|
70862177|NCT00667602|141210649|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-3.0|||||TWO_SIDED|95.0|-10.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC 9V, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-10|
70862178|NCT00667602|141210649|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-1.0|||||TWO_SIDED|95.0|-4.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC14, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-4|
70862179|NCT00667602|141210649|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-15.0|||||TWO_SIDED|95.0|-24.0|-6.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC18C, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||-6|-24|
70862180|NCT00667602|141210649|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-9.0|||||TWO_SIDED|95.0|-17.0|-1.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC19F, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||-1|-17|
70862181|NCT00667602|141210649|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-6.0|||||TWO_SIDED|95.0|-13.0|0.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC23F, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||0|-13|
70954375|NCT03568318|141411399|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|24.0|||<|0.001|TWO_SIDED|95.0|18.1|29.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||29.9|18.1|<0.001
71134356|NCT03652181|141771735|EQUIVALENCE|The null hypothesis is that the year 1 change is equivalent to year 2 change in mean DCEQP||||||0.3459|||||||t-test, 2 sided|||||||0.3459
71134357|NCT03652181|141771736|EQUIVALENCE|The null hypothesis is that the year 1 change is equivalent to year 2 numbers||||||1|||||||Chi-squared|||||||1.0
71134358|NCT01751984|141771802|SUPERIORITY||Least squares mean difference|-28.7|||<|0.0001|TWO_SIDED|95.0|-35.4|-22.1|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-22.1|-35.4|<0.0001
70862182|NCT00667602|141210654|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|71.0|||||TWO_SIDED|95.0|63.0|78.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:8, prevaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||78|63|
70954376|NCT03568318|141411400|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|38.8|||<|0.001|TWO_SIDED|95.0|32.8|44.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||44.8|32.8|<0.001
71134359|NCT01751984|141771803|SUPERIORITY||Least squares mean difference|-18.0|||<|0.0001|TWO_SIDED|95.0|-24.3|-11.8|||ANCOVA||Estimation from Week 2. The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-11.8|-24.3|<0.0001
71134360|NCT01751984|141771803|SUPERIORITY||Least squares mean difference|-30.0|||<|0.0001|TWO_SIDED|95.0|-35.2|-24.7|||ANCOVA||Estimation from Week 4. The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-24.7|-35.2|<0.0001
71134361|NCT01751984|141771803|SUPERIORITY||Least squares mean difference|-28.8|||<|0.0001|TWO_SIDED|95.0|-36.9|-20.8|||ANCOVA||Estimation from Week 6. The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-20.8|-36.9|<0.0001
71134362|NCT01751984|141771803|SUPERIORITY||Least squares mean difference|-28.5|||<|0.0001|TWO_SIDED|95.0|-37.2|-19.8|||ANCOVA||Estimation from Week 8. The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-19.8|-37.2|<0.0001
71134363|NCT01751984|141771804|SUPERIORITY||Least squares mean difference|-5.8||||0.1892|TWO_SIDED|95.0|-14.5|2.9|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||2.9|-14.5|0.1892
71134364|NCT01751984|141771805|SUPERIORITY||Least squares mean difference|-20.9|||<|0.0001|TWO_SIDED|95.0|-28.0|-13.9|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-13.9|-28.0|<0.0001
71134365|NCT01751984|141771806|SUPERIORITY||Least squares mean difference|-18.4|||<|0.0001|TWO_SIDED|95.0|-24.2|-12.7|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-12.7|-24.2|<0.0001
71134366|NCT01751984|141771807|SUPERIORITY||Least squares mean difference|18.7|||=|0.0962|TWO_SIDED|95.0|-3.5|40.8|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||40.8|-3.5|=0.0962
71134367|NCT01751984|141771808|SUPERIORITY||Least squares mean difference|-15.3|||=|0.0019|TWO_SIDED|95.0|-24.6|-6.0|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-6.0|-24.6|=0.0019
71134368|NCT01751984|141771809|SUPERIORITY||Least squares mean difference|-4.2|||=|0.2555|TWO_SIDED|95.0|-11.7|3.2|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||3.2|-11.7|=0.2555
71134369|NCT01751984|141771810|SUPERIORITY||Least squares mean difference|11.7||||0.2563|TWO_SIDED|95.0|-8.8|32.1|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||32.1|-8.8|0.2563
71134370|NCT01751984|141771811|SUPERIORITY||Least squares mean difference|-23.7||||0.2565|TWO_SIDED|95.0|-65.4|18.0|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||18.0|-65.4|0.2565
71134371|NCT01751984|141771812|SUPERIORITY||Least squares mean difference|4.0||||0.776|TWO_SIDED|95.0|-24.1|32.0|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||32.0|-24.1|0.7760
71134372|NCT01751984|141771813|SUPERIORITY||Clopper-Pearson methodology|61.8|||<|0.0001|TWO_SIDED|95.0|45.4|78.1||Based on Fisher's exact test comparing the proportion of participants who achieved LDL-C goal at Week 8 (End of Study) in the ETC-1002 and placebo groups.|Fisher Exact||ETC-1002 minus placebo for the proportion of participants who achieved LDL-C goal at Week 8 (End of Study). The confidence interval was based on a normal approximation to the binomial distribution.|||78.1|45.4|<0.0001
71134373|NCT01450761|141771849|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.936||||0.3775|TWO_SIDED|95.0|0.807|1.085|||Log Rank||HR = ipilimumab over placebo|||1.085|0.807|0.3775
71134374|NCT01450761|141771850|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.961||||0.5678|TWO_SIDED|95.0|0.838|1.102|||Log Rank||HR = ipilimumab over placebo|||1.102|0.838|0.5678
71134375|NCT01450761|141771851|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.851||||0.0161|TWO_SIDED|95.0|0.747|0.971|||Log Rank||HR = ipilimumab over placebo|||0.971|0.747|0.0161
71134376|NCT03573323|141771855|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71134377|NCT03573323|141771856|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71134378|NCT03573323|141771857|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71134379|NCT03573323|141771858|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71134380|NCT03573323|141771859|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71134381|NCT03573323|141771860|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71134382|NCT03573323|141771861|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71134383|NCT03573323|141771862|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71134384|NCT03573323|141771863|SUPERIORITY|||||||0.414|||||||Cochran-Mantel-Haenszel|||||||0.414
71134385|NCT04502290|141771867|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Paired t-test was used, where null hypothesis stated that the percent change in the number of blocks after intervention will be not statistically significant.||||.04
71134386|NCT04502290|141771868|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Paired t-test was used, where null hypothesis stated that the percent change in the motor evoked potnetial after intervention will be not statistically significant.||||.02
71134387|NCT04502290|141771869|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Paired t-test was used, where null hypothesis stated that the percent change in the force after intervention will be not statistically significant.||||.04
71134388|NCT02326064|141771884|SUPERIORITY||||||<|0.001|||||||Mac-Nemar paired Chi-2 test|||||||<0.001
71134389|NCT02326064|141771885|SUPERIORITY||||||<|0.001|||||||Mac-Nemar paired Chi-2 test|||||||<0.001
71134390|NCT00216671|141771886|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of early initiation was inferred if the upper 95% confidence boundary for the difference of change in PANSS total score from baseline in favor of the routine approach is less than 6.|Mean Difference (Net)|-1.13|STANDARD_ERROR_OF_MEAN|4.1||0.784|TWO_SIDED|95.0|-9.24|6.99||An ANCOVA model with treatment as factor was used. The comparison between the 2 treatment groups was performed based on the least-squares means obtained from the ANCOVA model.|ANCOVA|||Assuming a difference of 3 points in favor of early initiation of treatment with Risperdal Consta, a sample size of 87 subjects per treatment arm has a power of 80% to demonstrate non-inferiority at the 0.025-level (1-sided). It was expected that about 20% of randomized subjects had to be excluded from the per-protocol (PP) analysis. Therefore, 220 subjects were to be included.||6.99|-9.24|0.784
71134391|NCT00216671|141771889|SUPERIORITY_OR_OTHER|||||||0.8||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon two sample test|||Between-group comparison of the change in CGI-S from baseline to endpoint was analyzed as is with no derived calculations. CGI-S scores were coded as follows: 0=normal, not at all ill, 1=borderline, etc. and 6=among the most extremely ill patients.The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||0.800
71134392|NCT00216671|141771889|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in CGI-S from baseline to endpoint was analyzed as is with no derived calculations. CGI-S scores were coded as follows: 0=normal, not at all ill, 1=borderline, etc. and 6=among the most extremely ill patients.||||<0.001
71134393|NCT00216671|141771889|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in CGI-S from baseline to endpoint was analyzed as is with no derived calculations. CGI-S scores were coded as follows: 0=normal, not at all ill, 1=borderline, etc. and 6=among the most extremely ill patients.||||<0.001
71134394|NCT00216671|141771890|SUPERIORITY_OR_OTHER|||||||0.798||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon two sample test|||Between-group comparison of the change in GAF from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||0.798
71134395|NCT00216671|141771890|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in GAF from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.001
71134396|NCT00216671|141771890|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in GAF from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.001
71134397|NCT00216671|141771891|SUPERIORITY_OR_OTHER|||||||0.519||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon two sample test|||Between-group comparison of the change in SF-12 PCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||0.519
71134398|NCT00216671|141771891|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in SF-12 PCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.001
71134399|NCT00216671|141771891|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in SF-12 PCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.001
70862183|NCT00667602|141210654|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|2.0|||||TWO_SIDED|95.0|-3.0|6.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:8, one month postvaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||6|-3|
70862184|NCT00667602|141210654|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|2.0|||||TWO_SIDED|95.0|-2.0|7.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:8, prevaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||7|-2|
70862185|NCT00667602|141210654|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|-5.0|||||TWO_SIDED|95.0|-11.0|1.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:8, one month postvaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||1|-11|
70862186|NCT00667602|141210654|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|31.0|||||TWO_SIDED|95.0|24.0|39.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:128, prevaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||39|24|
70862187|NCT00667602|141210654|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:128, one month postvaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||4|-2|
70862188|NCT00667602|141210654|NON_INFERIORITY_OR_EQUIVALENCE|PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage Difference|4.0|||||TWO_SIDED|95.0|-3.0|11.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:128, prevaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||11|-3|
70862189|NCT00667602|141210654|NON_INFERIORITY_OR_EQUIVALENCE|PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage Difference|-13.0|||||TWO_SIDED|95.0|-22.0|-5.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:128, one month postvaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||-5|-22|
70862190|NCT00667602|141210654|NON_INFERIORITY_OR_EQUIVALENCE|PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage Difference|-10.0|||||TWO_SIDED|95.0|-17.0|-4.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (four-fold rise in titers), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||-4|-17|
70862191|NCT00667602|141210654|NON_INFERIORITY_OR_EQUIVALENCE|PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage Difference|-5.0|||||TWO_SIDED|95.0|-11.0|1.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (four-fold rise in titers), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||1|-11|
70872146|NCT01438957|141229567|SUPERIORITY||||||<|0.001|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||<0.001
70954377|NCT03568318|141411400|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|23.3|||<|0.001|TWO_SIDED|95.0|17.7|28.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||28.9|17.7|<0.001
71134400|NCT00216671|141771891|SUPERIORITY_OR_OTHER|||||||0.721||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon two sample test|||Between-group comparison of the change in SF-12 MCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||0.721
70862192|NCT00667602|141210656|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC)|Ratio|1.33|||||TWO_SIDED|95.0|0.96|1.83|||ANOVA|||For comparison of the Geometric Mean Titers at one month postvaccination at 12 months of age, MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the 2-sided 95% CI for the ratio of the MenACWY-CRM197 to MenC Geometric Mean Titers for serogroup C was greater than 0.5.||1.83|0.96|
70862193|NCT00644228|141210670|SUPERIORITY||Hazard Ratio (HR)|0.712||||0.0018|TWO_SIDED|96.0|0.56|0.906||The p-value is from a one-sided, stratified log-rank test. Stratification factors include those factors by which patients were randomized: intent to transplant (yes vs no) and ISS Stage (I vs II vs III).|Log Rank||The hazard ratio compares Bortezomib/Lenalidomide/Dexamethasone against Lenalidomide/Dexamethasone.|With four years of patient accrual and two and a half years of follow-up, 220 patients per arm yields 87% power to detect an increase of PFS of 50%, from a median of 3 years to 4.5 years, which corresponds to a hazard ratio of 1.5. These calculations are based on a one-sided stratified log-rank test at level 0.025 with two interim analyses. The final analysis will be carried out at the 0.02 significance level to allow for two interim analyses at the 0.0025 significance level.||0.906|0.560|0.0018
70862194|NCT00644228|141210671|SUPERIORITY||Hazard Ratio (HR)|0.709||||0.025|TWO_SIDED|95.0|0.524|0.959||The p-value is based on a two-sided, stratified log rank test. Stratification factors include those factors by which patients were randomized: intent to transplant (yes vs no) and ISS Stage (I vs II vs III).|Log Rank||The hazard ratio compares Bortezomib/Lenalidomide/Dexamethasone against Lenalidomide/Dexamethasone.|Overall survival will be compared between the two treatment arms using a stratified log-rank test.||0.959|0.524|0.0250
70862195|NCT00644228|141210672|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||||||The p-value is based on a stratified Cochran-Mantel-Haenszel test. Stratification factors include those factors by which patients were randomized: intent to transplant (yes vs no) and ISS Stage (I vs II vs III).|Cochran-Mantel-Haenszel|||||||0.20
70862196|NCT00973349|141210675|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|1.265|||||TWO_SIDED|95.0|0.998|1.603|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||1.603|0.998|
70862197|NCT00973349|141210675|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.999|||||TWO_SIDED|95.0|0.791|1.262|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||1.262|0.791|
70862198|NCT00973349|141210675|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.708|||||TWO_SIDED|95.0|0.558|0.897|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.897|0.558|
70862199|NCT00973349|141210675|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.861|||||TWO_SIDED|95.0|0.681|1.089|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||1.089|0.681|
70862200|NCT00973349|141210675|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.754|||||TWO_SIDED|95.0|0.596|0.956|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||0.956|0.596|
70862201|NCT00973349|141210675|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.548|||||TWO_SIDED|95.0|0.434|0.693|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.693|0.434|
70862202|NCT00973349|141210675|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.646|||||TWO_SIDED|95.0|0.51|0.817|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.817|0.510|
70862203|NCT00973349|141210675|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at 43|0.79|||||TWO_SIDED|95.0|0.625|1.0|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||1.000|0.625|
70862204|NCT00973349|141210675|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at 43|0.56|||||TWO_SIDED|95.0|0.441|0.71|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.710|0.441|
70862205|NCT00973349|141210675|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at 43|0.681|||||TWO_SIDED|95.0|0.538|0.862|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.862|0.538|
70862206|NCT00973349|141210675|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at 43|0.597|||||TWO_SIDED|95.0|0.47|0.757|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.757|0.470|
70862207|NCT00973349|141210675|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.434|||||TWO_SIDED|95.0|0.342|0.549|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.549|0.342|
70862208|NCT00973349|141210675|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.511|||||TWO_SIDED|95.0|0.403|0.647|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.647|0.403|
70872147|NCT01438957|141229567|SUPERIORITY|||||||0.003|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||0.003
70872148|NCT01438957|141229567|SUPERIORITY|||||||0.086|||||||Mantel Haenszel|Stratified by the anesthesia type||||||0.086
71134401|NCT00216671|141771891|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in SF-12 MCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.001
71134402|NCT00216671|141771891|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in SF-12 MCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.001
71134403|NCT01843023|141771985|SUPERIORITY||Mean Difference (Final Values)|0.558|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71134404|NCT01843023|141771987|SUPERIORITY||Mean Difference (Final Values)|0.722|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71134405|NCT00226811|141772018|SUPERIORITY_OR_OTHER||CBR rate (percentage)|7.7||||||95.0|2.9|16.0|||||Clinical benefit response rate: percent of patients with confirmed complete response, confirmed partial response or stable disease for at least 24 wks according to Response Evaluation Criteria in Solid Tumors, relative to total treated patients|||16.0|2.9|
71134406|NCT00226811|141772023|SUPERIORITY_OR_OTHER||OR rate (percentage)|2.6||||||95.0|0.3|9.0|||||Percentage of patients with confirmed complete response or confirmed partial response according to the Response Evaluation Criteria in Solid Tumors (RECIST), relative to the total number of treated patients.|||9.0|0.3|
71134407|NCT01010971|141772052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02|||<|0.0001|TWO_SIDED|95.0|0.59|1.45||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in rTNSS with a two-sided alpha level of 0.025.||1.45|0.59|<0.0001
71134408|NCT01010971|141772052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04|||<|0.0001|TWO_SIDED|95.0|0.61|1.46||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in rTNSS with a two-sided alpha level of 0.025.||1.46|0.61|<0.0001
71134409|NCT01010971|141772053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|||<|0.0001|TWO_SIDED|95.0|0.07|0.29|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.29|0.07|<0.0001
71134410|NCT01010971|141772053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|||<|0.0001|TWO_SIDED|95.0|0.08|0.29|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.29|0.08|<0.0001
71134411|NCT01010971|141772054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.1444|TWO_SIDED|95.0|-0.03|0.71||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons|ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.71|-0.03|0.1444
71134412|NCT01010971|141772054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.0124|TWO_SIDED|95.0|0.15|0.89||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons|ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.89|0.15|0.0124
71134413|NCT01010971|141772055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62||||0.0124|TWO_SIDED|95.0|0.3|0.94||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons|ANCOVA|||||0.94|0.30|0.0124
71134414|NCT01010971|141772055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64|||||TWO_SIDED|95.0|0.33|0.95||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons|ANCOVA|||||0.95|0.33|
71134415|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
71134416|NCT01128426|141772104|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71134417|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0 .99
71134418|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
71134419|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.2|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0 .20
71134420|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.79|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.79
71134421|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.16|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.16
71134422|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
71134423|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0 .03
71134424|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
71134425|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71134426|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71134427|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.18|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.18
71134428|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
71134429|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
71134430|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
71134431|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
70862209|NCT00973349|141210675|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.708|||||TWO_SIDED|95.0|0.56|0.896|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.896|0.560|
70862210|NCT00973349|141210675|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.862|||||TWO_SIDED|95.0|0.683|1.088|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||1.088|0.683|
70862211|NCT00973349|141210675|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.755|||||TWO_SIDED|95.0|0.597|0.954|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||0.954|0.597|
71134432|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
71134433|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
71134434|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
71134435|NCT01128426|141772104|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71134436|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
71134437|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
71134438|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
71134439|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71134440|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71134441|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71134442|NCT01128426|141772104|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71134443|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
71134444|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.26|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.26
71134445|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
71134446|NCT01128426|141772104|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71134447|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.09|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.09
71134448|NCT01128426|141772104|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71134449|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
71134450|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
71134451|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.71|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.71
71134452|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.83|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.83
71134453|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.74|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.74
71134454|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
71134455|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
71134456|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.79|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.79
71134457|NCT01128426|141772104|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71134458|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
71134459|NCT01128426|141772104|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71134460|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
71134461|NCT01128426|141772105|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71134462|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
71134463|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71134464|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
71134465|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71134466|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.61|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.61
71134467|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.42|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.42
71134468|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71134469|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.71|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.71
71134470|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.36|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.36
71134471|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.37|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.37
71134472|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.19|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.19
71134473|NCT01128426|141772105|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71134474|NCT01128426|141772105|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71134475|NCT01128426|141772105|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71134476|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.77|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.77
71134477|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
71134478|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
71134479|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
71134480|NCT01128426|141772105|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71134481|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
71134482|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.75|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.75
71134483|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
71134484|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
70862212|NCT00973349|141210675|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.549|||||TWO_SIDED|95.0|0.435|0.692|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||0.692|0.435|
71134485|NCT01128426|141772105|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71134486|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
71134487|NCT01128426|141772105|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71134488|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.12|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.12
71134489|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.83|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.83
71134490|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.12|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.12
71134491|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.26|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.26
70862213|NCT00973349|141210675|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.646|||||TWO_SIDED|95.0|0.511|0.817|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||0.817|0.511|
70862214|NCT00973349|141210675|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|1.217|||||TWO_SIDED|95.0|0.961|1.541|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||1.541|0.961|
70862215|NCT00973349|141210675|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|1.066|||||TWO_SIDED|95.0|0.841|1.352|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||1.352|0.841|
70862216|NCT00973349|141210675|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.775|||||TWO_SIDED|95.0|0.612|0.981|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||0.981|0.612|
70862217|NCT00973349|141210675|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.912|||||TWO_SIDED|95.0|0.719|1.157|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||1.157|0.719|
70862218|NCT00973349|141210675|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.876|||||TWO_SIDED|95.0|0.692|1.109|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||1.109|0.692|
70862219|NCT00973349|141210675|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.637|||||TWO_SIDED|95.0|0.504|0.804|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.804|0.504|
70862220|NCT00973349|141210675|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.75|||||TWO_SIDED|95.0|0.593|0.949|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.949|0.593|
70862221|NCT00973349|141210675|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.727|||||TWO_SIDED|95.0|0.574|0.919|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||0.919|0.574|
70862222|NCT00973349|141210675|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.856|||||TWO_SIDED|95.0|0.675|1.084|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||1.084|0.675|
70862223|NCT00973349|141210675|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|1.178|||||TWO_SIDED|95.0|0.931|1.489|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||1.489|0.931|
70862224|NCT02301988|141210691|SUPERIORITY||Difference in Response Rates|3.77||||0.519||95.0|-8.99|16.54|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified Analysis||16.54|-8.99|0.519
70954378|NCT03568318|141411401|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|21.2|||<|0.001|TWO_SIDED|95.0|16.3|26.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||26.1|16.3|<0.001
70862225|NCT02301988|141210692|SUPERIORITY||Difference in response rates|3.29||||0.7817|TWO_SIDED|95.0|-25.52|32.1|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified analysis||32.10|-25.52|0.7817
70862226|NCT02301988|141210693|SUPERIORITY||Difference in Response Rates|7.7||||0.2234|TWO_SIDED|95.0|-5.95|21.35|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified analysis||21.35|-5.95|0.2234
70862227|NCT02301988|141210694|SUPERIORITY||Difference in response rates|-2.96||||0.8169|TWO_SIDED|95.0|-33.91|27.99|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified analysis||27.99|-33.91|0.8169
70862228|NCT02301988|141210695|SUPERIORITY||Difference in response rate|11.11||||0.1607||95.0|-5.64|27.85|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified analysis||27.85|-5.64|0.1607
70862229|NCT02301988|141210696|SUPERIORITY||Difference in Response Rates|23.68||||0.1486|TWO_SIDED|95.0|-13.57|60.94|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified Analysis||60.94|-13.57|0.1486
70862230|NCT02301988|141210697|SUPERIORITY||Difference in Response Rates|6.09||||0.498|TWO_SIDED|95.0|-15.01|27.2|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction method.|||27.20|-15.01|0.4980
70862231|NCT02301988|141210698|SUPERIORITY||Difference in Response Rates|9.66||||0.3032||95.0|-12.25|31.58|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction method.|||31.58|-12.25|0.3032
70862232|NCT02301988|141210700|SUPERIORITY||Difference in Response Rates|4.2||||0.628|TWO_SIDED|95.0|-14.37|22.76|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction method.|||22.76|-14.37|0.6280
70862233|NCT02301988|141210701|SUPERIORITY||Difference in Response Rates|8.33||||0.6291|TWO_SIDED|95.0|-33.04|49.71|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction method.|||49.71|-33.04|0.6291
70862234|NCT04755283|141210705|SUPERIORITY||Hazard Ratio (HR)|0.314|||<|0.001|TWO_SIDED|95.0|0.192|0.513|||Stratified Log Rank Test|Stratified for stratification factors|Cox Proportional Hazards Model Adjusted for Stratification Factors|||0.513|0.192|<0.001
70862235|NCT04755283|141210705|SUPERIORITY||Hazard Ratio (HR)|0.382|||<|0.001|TWO_SIDED|95.0|0.243|0.602|||Stratified Log Rank Test|Stratified for stratification factors|Cox Proportional Hazards Model Adjusted for Stratification Factors|||0.602|0.243|<0.001
70862236|NCT04755283|141210706|SUPERIORITY||Hazard Ratio (HR)|0.263|||<|0.001|TWO_SIDED|95.0|0.121|0.572|||Stratified Log Rank Test|Stratified for stratification factors|Cox Proportional Hazards Model Adjusted for Stratification Factors|||0.572|0.121|<0.001
70862237|NCT04755283|141210706|SUPERIORITY||Hazard Ratio (HR)|0.325||||0.001|TWO_SIDED|95.0|0.159|0.663|||Stratified Log Rank Test|Stratified for stratification factors|Cox Proportional Hazards Model Adjusted for Stratification Factors|||0.663|0.159|0.001
70862238|NCT04755283|141210707|SUPERIORITY||Hazard Ratio (HR)|0.46|||<|0.001|TWO_SIDED|95.0|0.332|0.638|||Stratified Log Rank Test|Stratified for stratification factors|Cox Proportional Hazards Model Adjusted for Stratification Factors|||0.638|0.332|<0.001
70862239|NCT04755283|141210707|SUPERIORITY||Hazard Ratio (HR)|0.683||||0.01|TWO_SIDED|95.0|0.512|0.912|||Stratified Log Rank Test|Stratified for stratification factors|Cox Proportional Hazards Model Adjusted for Stratification Factors|||0.912|0.512|0.010
70862240|NCT02750943|141210708|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-25.34|||<|0.0001|TWO_SIDED|95.0|-30.682|-19.998||From ANCOVA analysis with treatment group, gender and baseline MGI stratification as factors baseline as covariates.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||-19.998|-30.682|<0.0001
70862241|NCT05098938|141210735|SUPERIORITY|||||||0.716|||||||Log Rank|||||||0.716
70862242|NCT05098938|141210736|SUPERIORITY|||||||0.102|||||||Chi-squared|||||||0.102
70862243|NCT05098938|141210737|SUPERIORITY|||||||0.712|||||||Chi-squared|||||||0.712
70862244|NCT05098938|141210738|SUPERIORITY|||||||0.575|||||||Log Rank|||||||0.575
70862245|NCT01828320|141210741|SUPERIORITY||d (effect size)|-0.08||||0.34|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||||||0.34
70862246|NCT01828320|141210742|SUPERIORITY||d (effect size)|-0.06||||0.93|TWO_SIDED||||||intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||||||0.93
70862247|NCT01828320|141210743|SUPERIORITY||d (effect size)|-0.5||||0.01|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.01
70862248|NCT01828320|141210744|SUPERIORITY||d (effect size)|0.18||||0.17|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.17
70862249|NCT01828320|141210745|SUPERIORITY||d (effect size)|0.07||||0.31|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.31
70862250|NCT01828320|141210746|SUPERIORITY||d (effect size)|0.001||||0.8|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.80
70862251|NCT01828320|141210747|SUPERIORITY||d (effect size)|0.04||||0.96|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.96
70862252|NCT01828320|141210748|SUPERIORITY||d (effect size)|-0.05||||0.83|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.83
70862253|NCT01828320|141210749|SUPERIORITY||d (effect size)|0.35||||0.02|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.02
70862254|NCT01828320|141210750|SUPERIORITY||d (effect size)|0.28||||0.04|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.04
70862255|NCT01828320|141210751|SUPERIORITY||d (effect size)|0.29||||0.04|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.04
70862256|NCT01828320|141210752|SUPERIORITY||d (effect size)|-0.44||||0.03|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||||||0.03
70862257|NCT01828320|141210753|SUPERIORITY||d (effect size)|0.07||||0.71|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.71
70862258|NCT01828320|141210754|SUPERIORITY||d (effect size)|0.02||||0.83|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.83
70862259|NCT01828320|141210755|SUPERIORITY||d (effect size)|-0.11||||0.85|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||||||0.85
70862260|NCT01828320|141210756|SUPERIORITY||d (effect size)|-0.55||||0.02|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.02
70862261|NCT01828320|141210757|SUPERIORITY||d (effect size)|-0.33||||0.05|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.05
70862262|NCT01828320|141210758|SUPERIORITY||d (effect size)|0.04||||0.88|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.88
70862263|NCT01828320|141210759|SUPERIORITY||d (effect size)|0.04||||0.97|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.97
70862264|NCT01828320|141210760|SUPERIORITY||d (effect size)|0.01||||0.88|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||"Composite Risk Score of Functioning in Social Domain measured via Ecological Momentary Assessment: Alone"||||0.88
70862265|NCT01828320|141210760|SUPERIORITY||d (effect size)|-0.18||||0.43|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||"Composite Risk Score of Functioning in Social Domain measured via Ecological Momentary Assessment: With a family member"||||0.43
70862266|NCT01828320|141210760|SUPERIORITY||d (effect size)|0.21||||0.37|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||"Composite Risk Score of Functioning in Social Domain measured via Ecological Momentary Assessment: With a peer"||||0.37
70862267|NCT01828320|141210761|SUPERIORITY||d (effect size)|0.29||||0.02|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.02
70862268|NCT01828320|141210762|SUPERIORITY||d (effect size)|0.07||||0.49|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.49
71134492|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.83|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.83
70862269|NCT01828320|141210763|SUPERIORITY||d (effect size)|0.11||||0.6|TWO_SIDED||||||intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||||||0.60
70862270|NCT01828320|141210764|SUPERIORITY||d (effect size)|0.08||||0.42|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.42
70862271|NCT01828320|141210765|SUPERIORITY||d (effect size)|0.4||||0.01|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||||||0.01
70862272|NCT02160782|141210799|EQUIVALENCE|The P-value for testing if the treatment group least squares (LS) means were equal was calculated to determine if the change in sBA levels between the treatment groups was statistically significant.|Mean Difference (Net)|-117.28|STANDARD_ERROR_OF_MEAN|52.828||0.0464|TWO_SIDED|95.0|-232.38|-2.18|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in fasting sBA levels was evaluated using an analysis of covariance (ANCOVA) model with treatment group as a factor, and Week 18 sBA as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the MITT population, which included all participants who were enrolled, received study drug through Week 18, and had a reduction from baseline in sBA of ≥50% at the Week 12 or Week 18 measurement.||-2.18|-232.38|0.0464
70862273|NCT02160782|141210800|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in sBA levels between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-87.73|STANDARD_DEVIATION|119.979||0.0005|TWO_SIDED|95.0|-133.37|-42.09||Data for this analysis were obtained from 31 participants at baseline; 29 of those participants contributed Week 18 data.|Student's t-test|||This analysis investigated whether a statistically significant change in sBA levels was observed when comparing baseline to Week 18 (the open-label period, during which all participants received MRX). The analysis was based on the ITT population.||-42.09|-133.37|0.0005
70862274|NCT02160782|141210801|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ItchRO(Obs) scores between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-1.704|STANDARD_DEVIATION|0.9114|<|0.0001|TWO_SIDED|95.0|-2.051|-1.357|||Student's t-test|||This analysis investigated whether a statistically significant change in ItchRO(Obs) score was observed when comparing baseline to Week 18 (the open-label period, during which all participants received MRX). The analysis was based on the ITT population. ItchRO scores range from 0 to 4; the higher score indicates increasing itch severity.||-1.357|-2.051|< 0.0001
70862275|NCT02160782|141210802|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ItchRO(Pt) scores between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-2.072|STANDARD_DEVIATION|0.9931|<|0.0001|TWO_SIDED|95.0|-2.645|-1.498|||Student's t-test|||This analysis investigated whether a statistically significant change in ItchRO(Pt) score was observed when comparing baseline to Week 18 (the open-label period, during which all participants received MRX). The analysis was based on the ITT population. ItchRO scores range from 0 to 4; the higher score indicates increasing itch severity.||-1.498|-2.645|< 0.0001
70872149|NCT01438957|141229567|SUPERIORITY||||||<|0.001|||||||Mantel-extension test|Stratified by the anesthesia type||Dose-response relationship is assessed using Mantel-extension test. In this analysis, dose of placebo group is hypothesized as 0 microg/kg. Dose-response relationship among Dexmedetomidine 4 dose groups excluding placebo group is also assessed using Mantel-extension test.||||<0.001
71134493|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
71134494|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
70862276|NCT02160782|141210803|EQUIVALENCE|The P-value for testing if the treatment group LS means were equal was calculated to determine if the change in ItchRO(Obs) between the treatment groups was statistically significant.|Mean Difference (Net)|-1.483|STANDARD_ERROR_OF_MEAN|0.3103|<|0.0001|TWO_SIDED|95.0|-2.122|-0.844|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in ItchRO(Obs) was evaluated using an ANCOVA model with treatment group as a factor, and Week 18 ItchRO(Obs) as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the intent-to-treat population, which included all participants who were enrolled, and received at least one dose of study drug.||-0.844|-2.122|< 0.0001
70862277|NCT02160782|141210804|EQUIVALENCE|The P-value for testing if the treatment group LS means were equal was calculated to determine if the change in ItchRO(Pt) between the treatment groups was statistically significant. While the number of participants included in analysis for the end point indicates 28, there were only 14; n = 5 for ItchRO(Pt): MRX and n = 9 for ItchRO(Pt): placebo.|Mean Difference (Net)|-1.988|STANDARD_ERROR_OF_MEAN|0.4641||0.0013|TWO_SIDED|95.0|-3.009|-0.967|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in ItchRO (Pt) was evaluated using an ANCOVA model with treatment group as a factor, and Week 18 ItchRO(Pt) as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the intent-to-treat population, which included all participants who were enrolled, and received at least one dose of study drug.||-0.967|-3.009|0.0013
70862278|NCT02160782|141210805|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ALP levels between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-27.8|STANDARD_DEVIATION|118.33||0.2163|TWO_SIDED|95.0|-72.8|17.2||Data for this analysis were obtained from 31 participants at baseline; 29 of those participants contributed Week 18 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ALP levels was observed when comparing baseline to Week 18 (the open-label period, during which all participants received MRX). The analysis was based on the ITT population.||17.2|-72.8|0.2163
70862279|NCT02160782|141210806|EQUIVALENCE|The P-value for testing if the treatment group LS means were equal was calculated to determine if the change in ALP levels between the treatment groups was statistically significant.|Mean Difference (Net)|10.0|STANDARD_ERROR_OF_MEAN|30.44||0.7455|TWO_SIDED|95.0|-52.6|72.6|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in ALP levels was evaluated using an ANCOVA model with treatment group as a factor, and Week 18 ALP as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the intent-to-treat population, which included all participants who were enrolled, and received at least one dose of study drug.||72.6|-52.6|0.7455
70862280|NCT02160782|141210807|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ALT levels between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-1.3|STANDARD_DEVIATION|84.54||0.9358|TWO_SIDED|95.0|-33.4|30.9||Data for this analysis were obtained from 31 participants at baseline; 29 of those participants contributed Week 18 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ALT levels was observed when comparing baseline to Week 18 (the open-label period, during which all participants received MRX). The analysis was based on the ITT population.||30.9|-33.4|0.9358
70862281|NCT02160782|141210808|EQUIVALENCE|The P-value for testing if the treatment group LS means were equal was calculated to determine if the change in ALT levels between the treatment groups was statistically significant.|Mean Difference (Net)|15.1|STANDARD_ERROR_OF_MEAN|19.53||0.4472|TWO_SIDED|95.0|-25.1|55.2|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in ALT levels was evaluated using an ANCOVA model with treatment group as a factor, and Week 18 ALT as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the intent-to-treat population, which included all participants who were enrolled, and received at least one dose of study drug.||55.2|-25.1|0.4472
70947908|NCT02641587|141396718|OTHER|"The analysis will test if the geometric LS mean level of COHb for CHTP is lower than for CC. The following hypothesis will be evaluated:~H0: XCHTP - XCC ≤ 0.0~HA: XCHTP - XCC \> 0.0~where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test)."|LS Mean Reduction|55.74|||<|0.001|TWO_SIDED|95.0|49.03|61.56||The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|Generalized linear model||Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC \[%\]), and their 95% CI.|Analysis will be conducted on the natural log scale. The Day 5 levels of COHb will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of COHb.||61.56|49.03|<0.001
71134495|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
71134496|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
70862282|NCT02160782|141210809|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in total bilirubin levels between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-0.47|STANDARD_DEVIATION|1.424||0.0893|TWO_SIDED|95.0|-1.01|0.08|||Student's t-test|||||0.08|-1.01|0.0893
70862283|NCT02160782|141210810|EQUIVALENCE|The P-value for testing if the treatment group LS means were equal was calculated to determine if the change in total bilirubin between the treatment groups was statistically significant.|Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.361||0.7|TWO_SIDED|95.0|-0.88|0.6|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in total bilirubin was evaluated using an ANCOVA model with treatment group as a factor, and Week 18 total bilirubin as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the intent-to-treat population, which included all participants who were enrolled, and received at least one dose of study drug.||0.6|-0.88|0.7
70862284|NCT02160782|141210811|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in direct bilirubin levels between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-0.5|STANDARD_DEVIATION|1.012||0.0139|TWO_SIDED|95.0|-0.9|-0.11|||Student's t-test|||||-0.11|-0.9|0.0139
70862285|NCT02160782|141210812|EQUIVALENCE|The P-value for testing if the treatment group LS means were equal was calculated to determine if the change in direct bilirubin between the treatment groups was statistically significant.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.265||0.9517|TWO_SIDED|95.0|-0.56|0.53|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in direct bilirubin levels was evaluated using an ANCOVA model with treatment group as a factor, and Week 18 direct bilirubin as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the intent-to-treat population, which included all participants who were enrolled, and received at least one dose of study drug.||0.53|-0.56|0.9517
70862286|NCT02476422|141210873|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.2||||0.211|TWO_SIDED|95.0|-1.8|8.3|||ANCOVA|||||8.3|-1.8|0.211
70862287|NCT01288027|141210886|SUPERIORITY_OR_OTHER|||||||0.186|TWO_SIDED||||||one sample t-test|||Statistical significance for change from Baseline was measured using one sample t-test||||0.1860
70862288|NCT00994318|141210893|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.026|TWO_SIDED|95.0|0.44|0.95|||Log Rank|||"FCM (Ferinject / Injectafer) targeting high ferritin level (400 - 600 mcg/L) compared with Oral Iron (Ferrous sulphate 100 mg iron twice daily).~Three primary comparisons using a hierarchical step-down procedure on the log-rank test to preserve the overall alpha level of 0.05, performed in the following order:~1. FCM (high ferritin target) compared with oral iron.~2. FCM (high ferritin target) compared with FCM (low ferritin target).~3. FCM (low ferritin target) compared with oral iron."||0.95|0.44|0.026
70862289|NCT00994318|141210893|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.082|TWO_SIDED|95.0|0.45|1.05|||Log Rank|||"FCM (Ferinject / Injectafer) targeting high ferritin level (400-600mcg/L) compared with FCM targeting low ferritin level (100 - 200 mcg/L).~Three primary comparisons using a hierarchical step-down procedure on the log-rank test to preserve the overall alpha level of 0.05, performed in the following order:~1. FCM (high ferritin target) compared with oral iron.~2. FCM (high ferritin target) compared with FCM (low ferritin target).~3. FCM (low ferritin target) compared with oral iron."||1.05|0.45|0.082
71134497|NCT01128426|141772105|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
70862290|NCT00994318|141210893|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.02|TWO_SIDED|95.0|0.39|0.93|||Log Rank|||"Sensitivity analysis of the primary endpoint. Time to initiation of additional or alternative anaemia management without taking into account the Hb trigger.~FCM (Ferinject / Injectafer) targeting high ferritin level (400 - 600 mcg/L) compared with Oral Iron (Ferrous sulphate 100 mg iron twice daily)."||0.93|0.39|0.020
70862291|NCT00994318|141210893|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.008|TWO_SIDED|95.0|0.43|0.88|||Log Rank|||"Sensitivity analysis of the primary endpoint. Time to initiation of additional or alternative anaemia management taking into account the Hb trigger based on local laboratory data, instead of central laboratory data.~FCM (Ferinject / Injectafer) targeting high ferritin level (400 - 600 mcg/L) compared with Oral Iron (Ferrous sulphate 100 mg iron twice daily)."||0.88|0.43|0.008
70862292|NCT00994318|141210893|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.12|TWO_SIDED|95.0|0.45|1.1|||Log Rank|||"Sensitivity analysis of the primary endpoint. Time to initiation of additional or alternative anaemia management taking into account the Hb trigger based on subjects with a complete set of Hb values from central laboratory.~FCM (Ferinject / Injectafer) targeting high ferritin level (400 - 600 mcg/L) compared with Oral Iron (Ferrous sulphate 100 mg iron twice daily)"||1.10|0.45|0.12
70862293|NCT00739999|141210902|SUPERIORITY_OR_OTHER_LEGACY||Atorvastatin CL/F based on 70 kg BW|699.0|||||TWO_SIDED|95.0|570.0|881.0|||non-linear mixed-effects model|Measures of parameter estimation uncertainty (95% CI) were determined by non-parametric bootstrap analysis.||Atorvastatin apparent clearance (CL/F) was described as a function of body weight using an allometric equation. The estimated parameter given is an extrapolation of the model for participants who weigh 70 kg.||881|570|
70862294|NCT03875768|141210940|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_DEVIATION|1.72||0.89|TWO_SIDED|95.0|-0.44|0.5||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Results presented are unadjusted.||The expected effect size is 0.5. The investigators hypothesize that the intervention will lead to an increase in average DASH score of 2 units. The investigators used a standard deviation for 2 units for both intervention and attention control groups since higher variability may be observed with a bigger sample size than the pilot study.||0.50|-0.44|0.89
70862295|NCT03875768|141210941|SUPERIORITY||Mean Difference (Net)|-1.9|STANDARD_DEVIATION|13.0||0.26|TWO_SIDED|95.0|-5.3|1.4||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Results presented are unadjusted.||The expected effect size for change in systolic blood pressure (SBP) between intervention and control group is 0.6 based on the pilot study. With a 90% power and a type I error rate (alpha) of .01, the investigators can detect the expected effect size with the proposed sample size of 121 per study arm.||1.4|-5.3|0.26
70862296|NCT03875768|141210942|SUPERIORITY||Mean Difference (Net)|-0.9|STANDARD_DEVIATION|8.3||0.39|TWO_SIDED|95.0|-3.1|1.2||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Results presented are unadjusted.||The expected effect size for change in diastolic blood pressure (DBP) between intervention and control group is 0.75 based on the pilot study. With a 90% power and a type I error rate (alpha) of .01, the investigators can detect the expected effect size with the proposed sample size of 121 per study arm.||1.2|-3.1|0.39
71134498|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.74|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.74
71134499|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.66|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.66
71134500|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
71134501|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
70954379|NCT03568318|141411402|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|16.2|||<|0.001|TWO_SIDED|95.0|11.3|21.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||21.1|11.3|<0.001
71134502|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.53|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.53
71134503|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.62|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.62
71134504|NCT01128426|141772105|SUPERIORITY_OR_OTHER|||||||0.77|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.77
71134505|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.77|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.77
71134506|NCT01128426|141772106|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71134507|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
71134508|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
71134509|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.2|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.20
71134510|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
71134511|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.79|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.79
71134512|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.09|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.09
71134513|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
71134514|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71134515|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.4|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.40
71134516|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
71134517|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
71134518|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.36|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.36
71134519|NCT01128426|141772106|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71134520|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
71134521|NCT01128426|141772106|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71134522|NCT01128426|141772106|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71134523|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
71134524|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
71134525|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
71134526|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.71|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.71
71134527|NCT01128426|141772106|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71134528|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
71134529|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
70862297|NCT00857415|141210957|SUPERIORITY_OR_OTHER||Correlation coefficient|0.78|STANDARD_ERROR_OF_MEAN|0.194|<|0.0001|TWO_SIDED|95.0|0.58|0.89||A one-sided test (rho \> 0) was performed with a significance level of alpha=0.05 to assess a significant correlation.|Spearman's Rank Correlation test||Asymptotic standard error and 95 percent CI used Fisher z-transformation.|Spearman's Rank Order Correlation of the median semiquantitative read (three readers) and the quantitative IHC measurement of cortical amyloid plaque density averaged across six brain regions.||0.89|0.58|<0.0001
70862298|NCT00857415|141210958|SUPERIORITY_OR_OTHER||Specificity|100.0|||||TWO_SIDED|95.0|91.0|100.0|||||95% CI calculated by Wilson score method|Proportion of subjects who had a negative scan based on majority of 3 blinded readers||100|91|
70862299|NCT01130103|141210968|SUPERIORITY_OR_OTHER||incident rate ratio|0.5||||0.01|TWO_SIDED|95.0|0.3|0.85|||Mixed Models Analysis|||caps total score at weeks 5 and 10||.85|.30|.01
70862300|NCT01130103|141210968|SUPERIORITY_OR_OTHER||incident rate ratio|0.56|||<|0.001|TWO_SIDED|95.0|0.43|0.74|||Mixed Models Analysis|||rate of change in CAPS total from week 5 to week 10||.74|.43|<.001
70862301|NCT01130103|141210972|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.6||||0.03|TWO_SIDED|95.0|1.23|129.0|||Mixed Models Analysis|||treatment group effect: remission rate at weeks 5 and 10||129|1.23|.03
70862302|NCT01130103|141210972|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.8||||0.007|TWO_SIDED|95.0|2.44|176.0|||Mixed Models Analysis|||rate of change over time in remission rate from week 5 to 10||176|2.44|0.007
70862303|NCT02992132|141210985|SUPERIORITY||Difference in LSM|5.1|STANDARD_ERROR_OF_MEAN|5.0|||TWO_SIDED|95.0|-4.8|15.0||||||Mixed-effect model repeated measures (MMRM), with the dependent variable being the change from Baseline in CMAI total score.||15.0|-4.8|
70862304|NCT02992132|141210985|SUPERIORITY||Difference in LSM|1.0|STANDARD_ERROR_OF_MEAN|4.8|||TWO_SIDED|95.0|-8.5|10.5||||||Mixed-effect model repeated measures (MMRM), with the dependent variable being the change from Baseline in CMAI total score.||10.5|-8.5|
70862305|NCT03194503|141210991|SUPERIORITY||Odds Ratio (OR)|0.65||||0.015|TWO_SIDED|95.0|0.47|0.92|||t-test, 2 sided|||This statistical analysis applies to all three rows in the post-intervention column. ITT analysis: Multivariable analysis for Any TIAEs, Severe TIAEs, and Severe desaturation(\>20%)||0.92|0.47|0.015
70862306|NCT03194503|141210992|SUPERIORITY||Odds Ratio (OR)|0.77||||0.25|TWO_SIDED|95.0|0.5|1.2|||t-test, 2 sided|||This statistical analysis applies to all three rows and is a per-protocol analysis: Multivariable analysis for Any TIAEs, Severe TIAEs, and Severe desaturation(\>20%)||1.20|0.50|0.250
70862307|NCT00337350|141210997|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANCOVA|||||||0.08
70862308|NCT00337350|141210998|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||||||.05
70862309|NCT00337350|141210999|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||ANCOVA|||||||0.21
70862310|NCT03911154|141211074|OTHER|We used linear mixed effect models (in SAS version 9.4, SAS Institute, Cary, NC) with random subject intercept to account for the clustered nature of the data. The model included factors for stimulus modality (4 levels), sleep restriction night (4 levels), and their interaction.|Mean Difference (Net)|0.329|STANDARD_ERROR_OF_MEAN|0.353||0.36|TWO_SIDED|95.0|-0.403|1.06|||Mixed Models Analysis|||Number of lapses of attention were averaged across assessments within each day and the statistical analysis adjusted for baseline.||1.060|-0.403|0.36
70862311|NCT03911154|141211074|OTHER|Linear mixed effects model with a random subject intercept.|Mean Difference (Net)|-0.307|STANDARD_ERROR_OF_MEAN|0.441||0.49|TWO_SIDED|95.0|-1.222|0.608|||Mixed Models Analysis|||Number of lapses of attention upon emergent awakening||0.608|-1.222|0.49
70862312|NCT03911154|141211075|OTHER|Linear mixed effects model with a random subject intercept.|Mean Difference (Net)|0.455|STANDARD_ERROR_OF_MEAN|2.797||0.87|TWO_SIDED|95.0|-5.4|6.31|||Mixed Models Analysis|||||6.310|-5.400|0.87
70862313|NCT03911154|141211076|OTHER|Linear mixed effects model with a random subject intercept.|Mean Difference (Net)|-0.112|STANDARD_ERROR_OF_MEAN|0.798||0.89|TWO_SIDED|95.0|-1.767|1.543|||Mixed Models Analysis|||Number correct on the DSST was averaged across DSST administrations within each day and was adjusted for baseline performance.||1.543|-1.767|0.89
70862314|NCT03911154|141211077|OTHER|Linear mixed effects model with a random subject intercept.|Mean Difference (Net)|-0.121|STANDARD_ERROR_OF_MEAN|0.381||0.76|TWO_SIDED|95.0|-0.919|0.678|||Mixed Models Analysis|||Number correct on the DST was averaged across DST administrations within each day and adjusted for baseline.||0.678|-0.919|0.76
70862315|NCT03911154|141211078|OTHER|Linear mixed effects model with a random subject intercept.|Mean Difference (Net)|0.085|STANDARD_ERROR_OF_MEAN|0.179||0.64|TWO_SIDED|95.0|-0.286|0.456|||Mixed Models Analysis|||The mean weighted score on the ROBoT was adjusted for baseline.||0.456|-0.286|0.64
70862316|NCT02035475|141211079|SUPERIORITY_OR_OTHER|||||||0.412|||||||McNemar|||The null hypothesis is that there is no difference in the incidence of detected lymphoceles whether the EndoWrist 1 Vessel Sealer or the Fenestrated Maryland BiPolar Instrument were used.||||0.412
70862317|NCT02047227|141211102|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.235||||0.054|TWO_SIDED|95.0|-0.4741|0.003|||Poisson Regression Model|||||0.003|-0.4741|0.054
70862318|NCT01209923|141211108|OTHER|||||||0.001|||||||t-test, 2 sided|Independent t-test||Children BIA was compared to hydrostatic weighing; adults were compared to DEXA.||||0.001
70862319|NCT01483807|141211109|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.254|ONE_SIDED||||||t-test, 1 sided|||Comparison of performance (change in articulation accuracy) with SPT-R versus SPT-B items. Based on the existing literature, it was predicted that the mean effect size associated with SPT-R would be greater than that for SPT-B.||||.254
70862320|NCT01483807|141211110|SUPERIORITY||Mean Difference (Final Values)|8.25||||0.043|ONE_SIDED||||||t-test, 1 sided|||On the basis of existing literature. SPT-R was predicted to be associated with greater increase in articulatory accuracy over baseline levels than SPT-B.||||.043
70862321|NCT01483807|141211111|SUPERIORITY|||||||0.396|||||||t-test, 1 sided|||Comparison of change in accuracy of articulation of untreated items: SPT-R versus SPT-B items. It was predicted that there would be a greater increase in accuracy for SPT-R items.||||.396
70862322|NCT01483807|141211112|SUPERIORITY|||||||0.212|||||||t-test, 1 sided|||Comparison of effect sizes obtained for untreated SPT-R versus untreated SPT-B items. It was predicted that effect sizes would be greater for SPT-R untreated items.||||.212
70862323|NCT03437512|141211148|SUPERIORITY||||||<|0.001||||||familywise error rate (FWE) corrected to .05 with cluster threshold of 80 voxels.|t-test, 2 sided|||||||<.001
70862324|NCT03437512|141211149|SUPERIORITY|||||||0.936||||||Interaction between visit and group.|ANOVA|||Analyses conduced with a mixed ANOVA, with between-subjects factor of group (active, sham) and two within-subjects factors: time (post, follow up) and speech task (reading, conversation).||||.936
70862325|NCT03437512|141211150|SUPERIORITY|||||||0.619||||||Interaction between visit and group.|ANOVA|||||||.619
71134530|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
71134531|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
71134532|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71134533|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.77|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.77
71134534|NCT01128426|141772106|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71134535|NCT01128426|141772106|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71134536|NCT01128426|141772106|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71134537|NCT01128426|141772106|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71134538|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.61|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.61
71134539|NCT01128426|141772106|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71134540|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
71134541|NCT01128426|141772106|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71134542|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
71134543|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
71134544|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.71|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.71
71134545|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.97|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.97
71134546|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71134547|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.26|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.26
71134548|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
71134549|NCT01128426|141772106|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71134550|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
71134551|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.85|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.85
71134552|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
71134553|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
71134554|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
71134555|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.09|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.09
71134556|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
71134557|NCT01128426|141772106|SUPERIORITY_OR_OTHER|||||||0.77|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.77
71134558|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71134559|NCT01128426|141772107|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
70862326|NCT00674973|141211154|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.1909|TWO_SIDED|95.0|0.63|1.1|||Log Rank|||Cox proportional hazards model was used to estimate the Hazard Ratio (erlotinib compared with placebo), including 95 percent (%) confidence intervals (CIs).||1.10|0.63|0.1909
70862327|NCT00763048|141211159|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||<0.05
70862328|NCT00763048|141211160|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||<0.05
70862329|NCT00763048|141211161|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||<0.05
70862330|NCT00763048|141211162|SUPERIORITY_OR_OTHER|||||||0.05|ONE_SIDED|95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||0.05
70862331|NCT00763048|141211163|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||0.05
70862332|NCT00763048|141211164|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||0.05
70862333|NCT00763048|141211165|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||0.05
70862334|NCT00763048|141211166|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||0.05
70862335|NCT00763048|141211167|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||0.05
70862336|NCT05108922|141211183|SUPERIORITY||Odds Ratio (OR)|29.26|||<|0.001|TWO_SIDED|95.0|5.3|100.0|||Regression, Logistic|||Analysis was based on logistic regression model with treatment, Apolipoprotein (ApoE) ε4 Carrier Status, baseline amyloid Level, baseline age as factors.||100.0|5.30|<0.001
70862337|NCT05108922|141211184|SUPERIORITY||Odds Ratio (OR)|15.18||||0.008|TWO_SIDED|95.0|2.04|100.0|||Regression, Logistic|||Analysis was based on logistic regression model with treatment, ApoE ε4 Carrier Status, baseline amyloid Level, baseline age as factors.||100.0|2.04|0.008
70862338|NCT05108922|141211185|SUPERIORITY||LS Mean difference (Final Values)|-45.691|STANDARD_ERROR_OF_MEAN|4.6132|<|0.001|TWO_SIDED|95.0|-54.84|-36.54||Analysis between treatment group comparison p-value using analysis of covariance (ANCOVA) model for endpoint measures: Change (CHG) = Baseline + ApoE ε4 Carrier Status + Baseline Age + Treatment|ANCOVA|||||-36.54|-54.84|<0.001
70862339|NCT05108922|141211186|SUPERIORITY||LS Mean difference (Final Values)|-48.213|STANDARD_ERROR_OF_MEAN|4.9276|<|0.001|TWO_SIDED|95.0|-57.99|-38.44||Analysis between treatment group comparison p-value using ANCOVA model for endpoint measures: Percent change (PCHG) = Baseline + ApoE ε4 Carrier Status + Baseline Age + Treatment|ANCOVA|||||-38.44|-57.99|<0.001
71134560|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
70862340|NCT05108922|141211187|SUPERIORITY||LS Mean difference (Final Values)|-40.252|STANDARD_ERROR_OF_MEAN|10.551|<|0.001|TWO_SIDED|95.0|-61.87|-18.64||Analysis between treatment group comparison p-value using ANCOVA model for endpoint measures: CHG = Baseline + ApoE ε4 Carrier Status + Baseline Age + Treatment|ANCOVA|||||-18.64|-61.87|<0.001
70862341|NCT05108922|141211188|SUPERIORITY||LS Mean difference (Final Values)|-23.97|STANDARD_ERROR_OF_MEAN|4.231|<|0.001|TWO_SIDED|95.0|-32.35|-15.6||Analysis between treatment group comparison p-value using mixed model for repeated measures (MMRM) model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||-15.60|-32.35|<0.001
70862342|NCT05108922|141211189|SUPERIORITY||LS Mean difference (Final Values)|-25.82|STANDARD_ERROR_OF_MEAN|4.381|<|0.001|TWO_SIDED|95.0|-34.49|-17.15||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||-17.15|-34.49|<0.001
70862343|NCT05108922|141211190|SUPERIORITY||Odds Ratio (OR)|8.38|||<|0.001|TWO_SIDED|95.0|3.37|20.81||Analysis was based on logistic regression model with 1 (Screening) value, ApoE4 Status, Age, Treatment, Time, and Treatment-by-time interaction as factors. Variance-Covariance structure = Unstructured|Regression, Logistic|||||20.81|3.37|<0.001
70862344|NCT05108922|141211191|SUPERIORITY||Odds Ratio (OR)|37.73|||<|0.001|TWO_SIDED|95.0|5.71|99.99||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Regression, Logistic|||||99.99|5.71|<.001
70862345|NCT05108922|141211192|SUPERIORITY||LS Mean difference (Final Values)|-26.75|STANDARD_ERROR_OF_MEAN|6.479|<|0.001|TWO_SIDED|95.0|-39.78|-13.73||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||-13.73|-39.78|<0.001
70862346|NCT05108922|141211193|SUPERIORITY||LS Mean difference (Final Values)|-7.931|STANDARD_ERROR_OF_MEAN|4.1187||0.0558|TWO_SIDED|95.0|-16.06|0.199||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||0.199|-16.060|0.0558
70862347|NCT05108922|141211194|NON_INFERIORITY|Non-inferiority margin of interest: 5 Centiloids|LS Mean difference (Final Values)|-7.931|STANDARD_ERROR_OF_MEAN|4.1187|||TWO_SIDED|95.0|-16.06|0.199||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||0.199|-16.060|
70862348|NCT05108922|141211195|SUPERIORITY||LS Mean difference (Final Values)|-12.04|STANDARD_ERROR_OF_MEAN|4.12||0.004|TWO_SIDED|95.0|-20.19|-3.88||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||-3.88|-20.19|0.004
71134561|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.91|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.91
70862349|NCT05108922|141211196|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
70862350|NCT05108922|141211197|SUPERIORITY||LS Mean difference (Final Values)|-13.45|STANDARD_ERROR_OF_MEAN|4.3||0.002|TWO_SIDED|95.0|-21.96|-4.93||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||-4.93|-21.96|0.002
70862351|NCT05108922|141211198|SUPERIORITY||Odds Ratio (OR)|4.68|||<|0.001|TWO_SIDED|95.0|1.93|11.34||Analysis was based on logistic regression model with 1 (Screening) value, ApoE4 Status, Age, Treatment, Time, and Treatment-by-time interaction as factors. Variance-Covariance structure = Unstructured.|Regression, Logistic|||||11.34|1.93|<0.001
70862352|NCT05108922|141211199|SUPERIORITY||Odds Ratio (OR)|6.34||||0.022|TWO_SIDED|95.0|1.32|30.54||Analysis was based on logistic regression model with 1 (Screening) value, ApoE4 Status, Age, Treatment, Time, and Treatment-by-time interaction as factors. Variance-Covariance structure = Unstructured.|Regression, Logistic|||||30.54|1.32|0.022
70862353|NCT05108922|141211200|SUPERIORITY||LS Mean difference (Final Values)|-14.33|STANDARD_ERROR_OF_MEAN|6.333||0.028|TWO_SIDED|95.0|-27.07|-1.59||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||-1.59|-27.07|0.028
70862354|NCT05108922|141211201|NON_INFERIORITY|Non-inferiority margin of interest: 5 Centiloids.|LS Mean difference (Final Values)|7.831|STANDARD_ERROR_OF_MEAN|4.087|||TWO_SIDED|95.0|-0.226|15.889||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||15.889|-0.226|
70862355|NCT02360995|141211271|SUPERIORITY_OR_OTHER|||||||0.652|TWO_SIDED||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.652
70862356|NCT02360995|141211272|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
70862357|NCT02360995|141211273|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
70862358|NCT02360995|141211274|SUPERIORITY_OR_OTHER|||||||0.533|TWO_SIDED||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.533
70862359|NCT02360995|141211275|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
70862360|NCT02360995|141211276|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
70862361|NCT02611960|141211284|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.2262|TWO_SIDED|95.0|0.67|1.19||One-sided p-value based on log-rank test stratified by presence of liver metastasis.|Stratified Log-Rank Test|||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by presence of liver metastasis.||1.19|0.67|0.2262
70862362|NCT02611960|141211285|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.9419|TWO_SIDED|95.0|0.94|1.75||One-sided p-value based on log-rank test stratified by presence of liver metastasis.|Stratified Log-Rank Test|||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by presence of liver metastasis.||1.75|0.94|0.9419
71134562|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.86|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.86
70862363|NCT02611960|141211286|SUPERIORITY||Difference in Percentage|-1.9||||0.63479|TWO_SIDED|95.0|-12.7|8.9||One-sided p-value for testing. H0: difference in percentage = 0 versus H1: difference in percentage \> 0.|Stratified Miettinen and Nurminen Method|||Comparison based on Miettinen \& Nurminen method stratified by presence of liver metastasis.||8.9|-12.7|0.63479
70862364|NCT00777205|141211331|SUPERIORITY_OR_OTHER||Slope|0.22|||<|0.05|TWO_SIDED|95.0|-1.57|2.01|||Mixed Models Analysis|||||2.01|-1.57|<0.05
70862365|NCT00777205|141211332|SUPERIORITY_OR_OTHER||Slope|-0.39|||<|0.05|TWO_SIDED|95.0|-2.03|1.24|||Mixed Models Analysis|||||1.24|-2.03|<0.05
70862366|NCT00777205|141211333|SUPERIORITY_OR_OTHER||Slope|0.81|||<|0.05|TWO_SIDED|95.0|-0.93|2.55|||Mixed Models Analysis|||||2.55|-0.93|<0.05
70862367|NCT00777205|141211334|SUPERIORITY_OR_OTHER||Slope|-0.039|||<|0.05|TWO_SIDED|95.0|-2.66|1.89|||Mixed Models Analysis|||||1.89|-2.66|<0.05
70862368|NCT00777205|141211335|SUPERIORITY_OR_OTHER||Slope|-0.08|||||TWO_SIDED|95.0|-3.31|3.16||||||||3.16|-3.31|
70862369|NCT03053271|141211344|OTHER|No statistical test was done as only 4 subjects could be enrolled, none met criteria for randomization, and the study was discontinued by the Sponsor.|||||||||||||||||No statistical test was done as only 4 subjects could be enrolled, none met criteria for randomization, and the study was discontinued by the Sponsor.|||
70862370|NCT02439879|141211408|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired t test|||All data were analyzed using the SPSS v16 statistical package software. To compare categorical variables, the chi2 test was used, and, for continuous variables,the T-test for independent or paired samples was applied.Data are expressed as percent values with 95% confidence intervals (CI) or mean ± SD or mean ± SEM||||< 0.05
70862371|NCT00943124|141211444|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|1.14||||||90.0|1.09|1.2||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||1.20|1.09|
70862372|NCT00943124|141211445|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|1.11||||||90.0|1.05|1.16||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||1.16|1.05|
71134563|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
71134564|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
70862373|NCT00943124|141211446|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|0.97||||||90.0|0.93|1.0||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||1.00|0.93|
70862374|NCT00943124|141211447|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|0.92||||||90.0|0.87|0.97||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||0.97|0.87|
70862375|NCT00943124|141211448|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|1.02||||||90.0|0.99|1.04||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||1.04|0.99|
70862376|NCT00943124|141211449|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|1.08||||||90.0|1.02|1.14||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||1.14|1.02|
70862377|NCT00943124|141211450|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|0.77||||||90.0|0.72|0.82||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||0.82|0.72|
70862378|NCT00943124|141211451|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|0.92||||||90.0|0.89|0.94||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||0.94|0.89|
70862379|NCT01916967|141211455|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-1.17|||<|0.001|TWO_SIDED|95.0|-1.69|-0.65|||Constrained Longitudinal Data Analysis|Model with terms of visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable||Difference in least squares (LS) means of Desloratadine 5 mg and Placebo||-0.65|-1.69|<0.001
70862380|NCT01916967|141211455|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-1.13|||<|0.001|TWO_SIDED|95.0|-1.66|-0.61|||Constrained Longitudinal Data Analysis|Model with terms of visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable||Difference in LS means of Desloratadine 10 mg and Placebo||-0.61|-1.66|<0.001
70862381|NCT01977937|141211491|OTHER|Differences in average pre-operative \& total post-operative average VAS scores were compared between groups using an unpaired Mann-Whitney rank sum test. Hospitalization outcomes including number of days to transition off PCA, number of days with Foley catheter, \& episodes of nausea, emesis, or POSS \> 3 were compared between groups using an unpaired two-tailed Student's t-test. Statistical significance was defined as p\<0.05 for all unpaired parametric and non-parametric comparisons.||||||0.07|||||||t-test, 2 sided|||D'Agostino \& Pearson normality test was used to assess for normal distribution. Experimental \& control groups were assessed for significant differences in age, hospital days, \& spinal levels fused using unpaired two-tailed Student's t-test. Differences in weight \& BMI were assessed using unpaired Mann-Whitney rank sum test. Differences in average VAS scores on the operative day, each post-operative day, and average total daily opioid were compared using an unpaired two-tailed Student's t-test.||||0.07
70862382|NCT01977937|141211492|OTHER|||||||0.02|||||||t-test, 2 sided|||Differences in the average total daily opioid were compared between groups using an unpaired two-tailed Student's t-test||||0.02
70862383|NCT01302379|141211509|SUPERIORITY||Mean Difference (Final Values)|1.0|||<|0.05|TWO_SIDED|95.0|-97.5|97.5||No adjustment for multiple comparisons|Mixed Models Analysis|||||97.5|-97.5|<0.05
70862384|NCT02001181|141211511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.8|STANDARD_ERROR_OF_MEAN|8.48|<|0.0001|TWO_SIDED|80.0|-62.8|-40.8|||Mixed Models Analysis|The mixed model for repeated measures analysis included all the participants in FAS.||||-40.8|-62.8|<0.0001
70862385|NCT01278160|141211518|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.12||||95.0|-0.24|0.22|||ANCOVA|The estimates were from a normal linear regression model with treatment and previous insulin as factors, and baseline value as a covariate.||The null hypothesis is H0: μBIAsp 30 (2:1) - μBIAsp 30 (1:1) = 0 against the alternative hypothesis HA: μBIAsp 30 (2:1) - μBIAsp 30 (1:1) ≠ 0. This trial is an extension to BIAsp-3756 (NCT01123980), hence no particular sample size calculation was made.||0.22|-0.24|
70872150|NCT01438957|141229568|SUPERIORITY||||||<|0.001|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||<0.001
71134565|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.11|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.11
70872151|NCT01438957|141229568|SUPERIORITY||||||<|0.001|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||<0.001
71134566|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
70862386|NCT01278160|141211519|SUPERIORITY_OR_OTHER||Mixed models analysis|0.2||||0.2569||95.0|-0.15|0.56||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is before breakfast profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp 30 OD/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.56|-0.15|0.2569
70862387|NCT01278160|141211519|SUPERIORITY_OR_OTHER||Mixed models analysis|0.09||||0.812||95.0|-0.63|0.8||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is two hours after breakfast profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.80|-0.63|0.8120
70862388|NCT01278160|141211519|SUPERIORITY_OR_OTHER||Mixed model analysis|0.35||||0.2843||95.0|-0.29|0.99||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is before lunch profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.99|-0.29|0.2843
70862389|NCT01278160|141211519|SUPERIORITY_OR_OTHER||Mixed model analysis|0.3||||0.4614||95.0|-0.5|1.11||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is two hours after lunch profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||1.11|-0.50|0.4614
70862390|NCT01278160|141211519|SUPERIORITY_OR_OTHER||Mixed model analysis|0.44||||0.1591||95.0|-0.17|1.04||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is before dinner profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||1.04|-0.17|0.1591
70862391|NCT01278160|141211519|SUPERIORITY_OR_OTHER||Mixed model analysis|0.03||||0.9327||95.0|-0.63|0.69||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is two hours after dinner profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.69|-0.63|0.9327
70862392|NCT01278160|141211519|SUPERIORITY_OR_OTHER||Mixed model analysis|-0.25||||0.4063||95.0|-0.84|0.34||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is bedtime profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.34|-0.84|0.4063
70862393|NCT01278160|141211519|SUPERIORITY_OR_OTHER||Mixed model analysis|0.3||||0.2198||95.0|-0.18|0.79||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is 2.00 - 4.00 a.m. profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.79|-0.18|0.2198
70862394|NCT01278160|141211519|SUPERIORITY_OR_OTHER||Mixed model analysis|-0.04||||0.8424||95.0|-0.47|0.38|||Mixed Models Analysis||Confidence interval is before breakfast the following day profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.38|-0.47|0.8424
70862395|NCT01278160|141211520|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.7312||95.0|0.36|2.06|||Regression, Logistic||The odds ratio and 95% confidence interval for the HbA1c below 7% treatment target were included.|Responder analyses were based on logistics regression model using treatment and previous therapy (BIAsp 30 OD or insulin glargine OD) as factors and baseline HbA1c as covariate.||2.06|0.36|0.7312
70862396|NCT01278160|141211521|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||0.1257||95.0|0.05|1.44|||Regression, Logistic|The estimates were from a normal linear regression model with treatment and previous insulin as factors, and baseline value as a covariate|The odds ratio and 95% confidence interval for the HbA1c below or equal to 6.5% treatment target were included.|Responder analyses were based on logistics regression model using treatment and previous therapy (BIAsp 30 OD or insulin glargine OD) as factors and baseline HbA1c as covariate.||1.44|0.05|0.1257
70872152|NCT01438957|141229568|SUPERIORITY|||||||0.006|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||0.006
70872153|NCT01438957|141229568|SUPERIORITY|||||||0.329|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||0.329
71134567|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
70862397|NCT01278160|141211522|SUPERIORITY_OR_OTHER||Rate ratio|0.72||||0.1911||95.0|0.43|1.18|||Negative binomial regression model||For all episodes.|The number of hypos was analysed using a negative binomial regression model with a log-link function and the logarithm of the time period in which a hypo is considered emergent as offset. The model included treatment and previous therapy (BIAsp 30 OD/insulin glargine OD) as factors. The rate ratio was estimated and 95% confidence intervals were calculated accordingly.||1.18|0.43|0.1911
71134568|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71134569|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
71134570|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.42|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.42
71134571|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
71134572|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.88|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.88
71134573|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.79|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.79
71134574|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.57|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.57
71134575|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
71134576|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71134577|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71134578|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.42|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.42
71134579|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
71134580|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71134581|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.57|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.57
71134582|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
71134583|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71134584|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
71134585|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.46|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.46
71134586|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71134587|NCT01128426|141772107|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71134588|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.88|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.88
71134589|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
71134590|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.93|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.93
71134591|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
71134592|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71134593|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
71134594|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.9|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.90
71134595|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.11|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.11
71134596|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
71134597|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.09|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.09
71134598|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.34|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.34
71134599|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.92|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.92
71134600|NCT01128426|141772107|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71134601|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.62|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.62
71134602|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.49|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.49
71134603|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
71134604|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71134605|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71134606|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71134607|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.11|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.11
71134608|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71134609|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
71134610|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
71134611|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
71134612|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.35|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.35
71134613|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
71134614|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
71134615|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71134616|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.35|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.35
71134617|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
71134618|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.3|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.30
71134619|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71134620|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
71134621|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.45|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.45
71134622|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.66|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.66
71134623|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71134624|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
71134625|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.17|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.17
70862398|NCT01278160|141211522|SUPERIORITY_OR_OTHER||Rate ratio|1.61||||0.2949||95.0|0.66|3.92|||Negative binomial regression model||For nocturnal episodes.|The number of hypos was analysed using a negative binomial regression model with a log-link function and the logarithm of the time period in which a hypo is considered emergent as offset. The model included treatment and previous therapy (BIAsp 30 OD/insulin glargine OD) as factors. The rate ratio was estimated and 95% confidence intervals were calculated accordingly.||3.92|0.66|0.2949
70862399|NCT01278160|141211522|SUPERIORITY_OR_OTHER||Rate ratio|0.63||||0.077||95.0|0.38|1.05|||Negative binomial regression model||For diurnal episodes.|The number of hypos was analysed using a negative binomial regression model with a log-link function and the logarithm of the time period in which a hypo is considered emergent as offset. The model included treatment and previous therapy (BIAsp 30 OD/insulin glargine OD) as factors. The rate ratio was estimated and 95% confidence intervals were calculated accordingly.||1.05|0.38|0.0770
70954380|NCT03568318|141411402|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|9.2|||<|0.001|TWO_SIDED|95.0|4.9|13.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||13.4|4.9|<0.001
71134626|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
70862400|NCT01278160|141211522|SUPERIORITY_OR_OTHER||Rate ratio|0.56||||0.1687||95.0|0.25|1.27|||Negative binomial regression model||For minor episodes.|The number of hypos was analysed using a negative binomial regression model with a log-link function and the logarithm of the time period in which a hypo is considered emergent as offset. The model included treatment and previous therapy (BIAsp 30 OD/insulin glargine OD) as factors. The rate ratio was estimated and 95% confidence intervals were calculated accordingly.||1.27|0.25|0.1687
70862401|NCT02819518|141211525|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.012|TWO_SIDED|95.0|0.7|0.98||One-sided p-value based on log-rank test stratified by chemotherapy (taxane versus \[vs\] gemcitabine/carboplatin), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs. no).|Log Rank||Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, tumor PD-L1 status, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.|||0.98|0.70|0.0120
70872154|NCT01438957|141229569|SUPERIORITY||||||<|0.001|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||<0.001
71134627|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
71134628|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71134629|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.12|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.12
71134630|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.92|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.92
71134631|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.09|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.09
71134632|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.87|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.87
71134633|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71134634|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71134635|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
71134636|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71134637|NCT01128426|141772108|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71134638|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.91|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.91
71134639|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71134640|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
71134641|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71134642|NCT01128426|141772108|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71134643|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.59|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.59
71134644|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
71134645|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
71134646|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
71134647|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.86|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.86
70862402|NCT02819518|141211526|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0016|TWO_SIDED|95.0|0.62|0.91||One-sided p-value based on log-rank test stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|Log Rank||Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.|||0.91|0.62|0.0016
70862403|NCT02819518|141211527|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0018|TWO_SIDED|95.0|0.5|0.88||One-sided p-value based on log-rank test stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|Log Rank||Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.|||0.88|0.50|0.0018
70862404|NCT02819518|141211528|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.0797|TWO_SIDED|95.0|0.76|1.05||One-sided p-value based on log-rank test stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|Log Rank||Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, tumor PD-L1 status, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.|||1.05|0.76|0.0797
70862405|NCT02819518|141211529|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0563|TWO_SIDED|95.0|0.72|1.04||One-sided p-value based on log-rank test stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|Log Rank||Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.|||1.04|0.72|0.0563
70862406|NCT02819518|141211530|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0093|TWO_SIDED|95.0|0.55|0.95||One-sided p-value based on log-rank test stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|Log Rank||Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.|||0.95|0.55|0.0093
70862407|NCT02819518|141211531|SUPERIORITY||Difference in ORR (%) vs. Control|3.8||||0.1413|TWO_SIDED|95.0|-3.2|10.6|||Cochran-Mantel-Haenszel||Based on Miettinen \& Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|||10.6|-3.2|0.1413
70862408|NCT02819518|141211532|SUPERIORITY||Difference in ORR (%) vs. Control|6.1||||0.0725|TWO_SIDED|95.0|-2.1|14.0|||Cochran-Mantel-Haenszel||Based on Miettinen \& Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|||14.0|-2.1|0.0725
70862409|NCT02819518|141211533|SUPERIORITY||Difference in ORR(%) vs. Control|12.1||||0.0213|TWO_SIDED|95.0|0.4|23.4|||Cochran-Mantel-Haenszel||Based on Miettinen \& Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin) and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|||23.4|0.4|0.0213
70862410|NCT02819518|141211537|SUPERIORITY||Difference in DCR (%) vs. control|4.7||||0.0966|TWO_SIDED|95.0|-2.4|11.8|||Cochran-Mantel-Haenszel||Based on Miettinen \& Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and prior treatment with same class of chemotherapy in the (neo) adjuvant setting (yes vs no).|||11.8|-2.4|0.0966
70862411|NCT02819518|141211538|SUPERIORITY||Difference in DCR (%) vs. Control|5.0||||0.1164|TWO_SIDED|95.0|-3.2|13.1|||Cochran-Mantel-Haenszel||Based on Miettinen \& Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin) and prior treatment with same class of chemotherapy in the (neo) adjuvant setting (yes vs no).|||13.1|-3.2|0.1164
70862412|NCT02819518|141211539|SUPERIORITY||Difference in DCR (%) vs. Control|10.8||||0.0327|TWO_SIDED|95.0|-0.7|22.3|||Cochran-Mantel-Haenszel||Based on Miettinen \& Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin) and prior treatment with same class of chemotherapy in the (neo) adjuvant setting (yes vs no).|||22.3|-0.7|0.0327
70862413|NCT01505647|141211548|NON_INFERIORITY_OR_EQUIVALENCE|The GMT induced by ZOSTAVAX™ (AMP) vaccine is statistically non-inferior to that induced by the current process vaccine if the lower bound of the 95% confidence interval of the GMT ratio is \>0.67.|GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.98|1.2||The threshold for statistical significance is 0.025 (1-sided). The P-value was not adjusted.|Longitudinal regression model|The analyzed GMT ratio, 95% confidence interval, and P-value were based on a longitudinal regression model adjusting for age and vaccination group||The hypothesis tested is that the GMT at Week 6 postvaccination with ZOSTAVAX™ (AMP) vaccine is non-inferior to that with the current process vaccine||1.20|0.98|<0.001
70862414|NCT01505647|141211549|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The threshold for statistical significance is 0.025 (1-sided). The P-value was not adjusted.|t-test, 1 sided|||The hypothesis tested was that ZOSTAVAX™ (AMP) induces an acceptable GMFR in VZV antibody titer from prevaccination to 6 weeks postvaccination||||<0.001
70862415|NCT05597020|141211583|SUPERIORITY||Least Square mean difference vs placebo|20.9||||0.002|TWO_SIDED|95.0|8.0|33.7|||Mixed Models Analysis|Treatment, period, week within period, and interaction of treatment and week were factors; baseline sTST assessment was covariate.||||33.7|8.0|0.002
70862416|NCT05169567|141211585|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.02|TWO_SIDED|95.0|0.57|0.95|||Log Rank|||||0.95|0.57|0.02
70862417|NCT01015131|141211589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1521|||<|0.01|TWO_SIDED|90.0|0.0932|0.2111|||paired t-test|||||0.2111|0.0932|<0.01
70862418|NCT03029702|141211601|SUPERIORITY|||||||0.9|||||||Fisher Exact|||||||0.9
70862419|NCT03029702|141211602|SUPERIORITY|||||||0.8|||||||Fisher Exact|||||||0.8
70862420|NCT03029702|141211603|SUPERIORITY|||||||0.9|||||||Fisher Exact|||||||0.9
70862421|NCT03029702|141211604|SUPERIORITY|||||||0.9|||||||Fisher Exact|||||||0.9
70862422|NCT03029702|141211605|SUPERIORITY|||||||0.8|||||||Fisher Exact|||||||0.8
70862423|NCT03029702|141211606|SUPERIORITY|||||||0.6|||||||Chi-squared|||||||0.6
70862424|NCT03029702|141211607|SUPERIORITY|||||||0.8|||||||Chi-squared|||||||0.8
70862425|NCT03029702|141211608|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.7
70862426|NCT05595382|141211616|SUPERIORITY|Repeated measures of likelihood to enroll (on a 1 to 7 scale with higher numbers indicating a greater likelihood) pre/post intervention||||||0.001|||||||ANOVA|Degrees of freedom (1, 359)||||||.001
70862427|NCT05595382|141211617|SUPERIORITY|||||||0.357|||||||ANOVA|Degrees of freedom (1, 358)||Repeated measures ANOVA comparing mood (rated on a 1-10 scale with higher scores indicating better mood) given to participants before and after the study manipulation by group||||.357
70862428|NCT05595382|141211618|SUPERIORITY|||||||0.102|||||||ANOVA|||||||.102
70862429|NCT02445391|141211627|NON_INFERIORITY|The null hypothesis for testing non-inferiority of platinum was defined as that the hazard ratio (HR) for platinum/capecitabine ≥ 1.154 (ie, HR of 1.154 was used as the non-inferiority margin). The alternative hypothesis was HR=0.754 for platinum/ capecitabine. The 4-year IDFS rate was expected to be 67% on capecitabine arm.|Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.62|1.81|||||The 95% confidence interval provided above was the Jennison and Turnbull repeated confidence interval.|||1.81|0.62|
70862430|NCT03722173|141211633|OTHER|Since the main focus was on estimation and not testing, a formal hypothesis test and associated acceptance range was not specified; no hypothesis was tested.|gMeans ratio (T/R) %|141.62|STANDARD_ERROR_OF_MEAN|13.3|||TWO_SIDED|90.0|129.64|154.71|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects for 'subjects' and 'treatment' was used.|Standard error of the mean is actually an intra-individual coefficient variation (CV). Confidence intervals (CIs) were calculated based on the residual error from the ANOVA and quantiles from the t distribution.|Point estimates for the ratios of the geometric means (gMeans) (T/R) for AUC0-tz and their 2-sided 90% confidence intervals (CIs) were provided. The difference between the expected means for log(T) - log(R) were estimated by the difference in the corresponding adjusted means (Least Squares Means).||154.71|129.64|
70862431|NCT03722173|141211634|OTHER|Since the main focus was on estimation and not testing, a formal hypothesis test and associated acceptance range was not specified; no hypothesis was tested.|gMeans ratio (T/R) %|113.32|STANDARD_ERROR_OF_MEAN|15.1|||TWO_SIDED|90.0|102.47|125.32|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects for 'subjects' and 'treatment' was used.|Standard error of the mean is actually an intra-individual coefficient variation (CV). Confidence intervals (CIs) were calculated based on the residual error from the ANOVA and quantiles from the t distribution.|Point estimates for the ratios of the gMeans (T/R) for Cmax and their 2-sided 90% CIs were provided. The difference between the expected means for log(T) - log(R) were estimated by the difference in the corresponding adjusted means (Least Squares Means).||125.32|102.47|
70862432|NCT03722173|141211635|OTHER|Since the main focus was on estimation and not testing, a formal hypothesis test and associated acceptance range was not specified; no hypothesis was tested.|gMeans ratio (T/R) %|142.54|STANDARD_ERROR_OF_MEAN|13.5|||TWO_SIDED|90.0|130.3|155.93|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects for 'subjects' and 'treatment' was used.|Standard error of the mean is actually an intra-individual coefficient variation (CV). Confidence intervals (CIs) were calculated based on the residual error from the ANOVA and quantiles from the t distribution.|Point estimates for the ratios of the gMeans (T/R) for AUC0-∞ and their 2-sided 90% CIs were provided. The difference between the expected means for log(T) - log(R) were estimated by the difference in the corresponding adjusted means (Least Squares Means).||155.93|130.30|
70862433|NCT06624449|141211636|SUPERIORITY||Mean Difference (Final Values)|0.09|||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.05
70862434|NCT00413400|141211638|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||ANCOVA|||treatment effect (etanercept vs. placebo) using ANCOVA including baseline CRP, age, and race||||0.20
70862435|NCT00413400|141211639|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||Repeated Measures ANCOVA|||within subject percent changes calculated for each timepoint and repeated measures ANCOVA controlling for age and race performed||||0.92
70862436|NCT00413400|141211640|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Repeated Measures ANCOVA|||within subject percent changes were calculated for each time point, then repeated measures ANCOVA controlling for age and race performed||||0.02
71134648|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
70862437|NCT00413400|141211641|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||repeated measures ANCOVA|||percent change calculated then repeated measures ANCOVA performed controlling for age and race||||0.02
70862438|NCT00413400|141211642|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANCOVA|||ANCOVA controlling for baseline value, age, race||||0.46
70862439|NCT00413400|141211643|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||t-test, 2 sided|||||||0.78
70862440|NCT00413400|141211644|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||t-test, 2 sided|||||||0.11
70862441|NCT00413400|141211645|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||ANCOVA|||ANCOVA controlling for baseline value, age, race||||0.59
70862442|NCT00413400|141211646|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Repeated measures ANCOVA|||within subject percent changes calculated then repeated measures ANCOVA controlling for age and race performed||||<0.0001
70862443|NCT00413400|141211647|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Repeated Measures ANCOVA|||within subject percent changes calculated then repeated measures ANCOVA performed controlling for age and race||||0.08
70862444|NCT00413400|141211648|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||ANCOVA|||ANCOVA controlling for baseline value, age, and race||||0.55
70862445|NCT00891462|141211650|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.086|||<|0.0001|TWO_SIDED|95.0|0.05|0.13|||ANCOVA|||||0.13|0.05|<0.0001
70862446|NCT00891462|141211650|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.124|||<|0.0001|TWO_SIDED|95.0|0.08|0.16|||ANCOVA|||||0.16|0.08|<0.0001
70862447|NCT00518687|141211666|SUPERIORITY_OR_OTHER||Vaccine Efficacy (VE)|18.5||||0.584|TWO_SIDED|95.0|-48.6|55.8||A 1-sided p-value \<0.025 implies that the V710 vaccine efficacy is statistically significantly greater than 20%|Exact 1-sided binomial test||VE = 1 - Relative Risk of V710 compared with placebo|||55.8|-48.6|0.584
70862448|NCT00518687|141211667|SUPERIORITY_OR_OTHER||Estimated rate difference|0.0||||0.997|TWO_SIDED|95.0|-0.1|0.1|||Miettinen and Nurminen|||||0.1|-0.1|0.997
71134649|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
71134650|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.1|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.10
71134651|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
71134652|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71134653|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.19|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.19
71134654|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.18|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.18
71134655|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
71134656|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.35|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.35
71134657|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
71134658|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.42|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.42
71134659|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.29|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.29
71134660|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.11|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.11
70872155|NCT01438957|141229569|SUPERIORITY||||||<|0.001|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||<0.001
70872156|NCT01438957|141229569|SUPERIORITY|||||||0.006|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||0.006
71134661|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||1|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||1.00
71134662|NCT01128426|141772109|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71134663|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.16|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.16
71134664|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.19|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.19
71134665|NCT01128426|141772109|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71134666|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.4|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.40
71134667|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
71134668|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71134669|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
71134670|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71134671|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.57|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.57
71134672|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
71134673|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
70872157|NCT01438957|141229569|SUPERIORITY|||||||0.371|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||0.371
71134674|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
71134675|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
71134676|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
71134677|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71134678|NCT01128426|141772109|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71134679|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
71134680|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
71134681|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
71134682|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
71134683|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71134684|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
71134685|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.65|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.65
71134686|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71134687|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.1|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.10
70862449|NCT00518687|141211668|SUPERIORITY_OR_OTHER||Vaccine Efficacy (VE)|12.9||||0.347|TWO_SIDED|95.0|-50.8|50.0||A 1-sided p-value \<0.025 implies that the V710 vaccine efficacy is statistically significant|Exact 1-sided binomial test||VE = 1 - Relative Risk of V710 compared with placebo|||50.0|-50.8|0.347
70862450|NCT00518687|141211669|SUPERIORITY_OR_OTHER||Vaccine Efficacy (VE)|29.3||||0.032|TWO_SIDED|95.0|-1.8|51.2||A 1-sided p-value \<0.025 implies that the V710 vaccine efficacy is statistically significant|Exact 1-sided binomial test||VE = 1 - Relative Risk of V710 compared with placebo|||51.2|-1.8|0.032
70862451|NCT02339285|141211684|OTHER|F-test; Treatment effect|||||>|0.1|||||||ANOVA|F(2, 29)||"Null hypothesis: There is no difference baseline and the 4 week follow up in MADRS score between treatment groups.~Alternative hypothesis: There is a difference between baseline and the 4 week follow up MADRS score between treatment groups."||||>0.10
71134688|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
71134689|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
71134690|NCT01128426|141772109|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71134691|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.91|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.91
71134692|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71134693|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
71134694|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71134695|NCT01128426|141772109|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71134696|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
71134697|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.87|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.87
71134698|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
71134699|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
71134700|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71134701|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71134702|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
71134703|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.19|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.19
71134704|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
71134705|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.66|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.66
71134706|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
71134707|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
71134708|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71134709|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
71134710|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
71134711|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.8|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.80
71134712|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
71134713|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
70862452|NCT02339285|141211684|OTHER|F-test; Session effect|||||<|0.001|||||||ANOVA|F(1, 31)||"Null hypothesis: There is no difference baseline and the 4 week follow up in MADRS score between treatment groups.~Alternative hypothesis: There is a difference between baseline and the 4 week follow up MADRS score between treatment groups."||||<0.001
71134714|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.92|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.92
71134715|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.76|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.76
71134716|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.91|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.91
71134717|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
71134718|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
71134719|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71134720|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71134721|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71134722|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71134723|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.34|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.34
71134724|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
71134725|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
70862453|NCT02339285|141211684|OTHER|F-test; Interaction effect (session x treatment)|||||>|0.1|||||||ANOVA|F(2,29)||||||>0.10
70862454|NCT02339285|141211685|OTHER|F-test; Condition effect|||||<|0.05|||||||ANOVA|F(2,21.595)||"Null hypothesis: There is no difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups.~Alternative hypothesis: There is a difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups."||||<0.05
71134726|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.69|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.69
71134727|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71134728|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71134729|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71134730|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.4|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.40
71134731|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71134732|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71134733|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
71134734|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
71134735|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71134736|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71134737|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.8|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.80
71134738|NCT01128426|141772110|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71134739|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71134740|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
71134741|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
71134742|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
70862455|NCT02339285|141211685|OTHER|F-test; Region effect (region defined as region of brain - frontal, parietal, occipital temporal)|||||<|0.001|||||||ANOVA|F(3, 79.358)||"Null hypothesis: There is no difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups.~Alternative hypothesis: There is a difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups."||||<0.001
70862456|NCT02339285|141211685|OTHER|F-test; Interaction effect (region x condition)|||||>|0.1|||||||ANOVA|F(6, 68.284)||"Null hypothesis: There is no difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups.~Alternative hypothesis: There is a difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups."||||>0.10
70862457|NCT02339285|141211686|OTHER||||||>|0.1|||||||ANOVA|||"Null hypothesis: There is no difference in changes of alpha frequency power between baseline EEG and EEG 4 weeks after completion of the intervention between treatment groups.~Alternative hypothesis: There is a difference in changes of alpha frequency power between baseline EEG and EEG 4 weeks after completion of the intervention between treatment groups."||||>0.10
70862458|NCT00145600|141211764|SUPERIORITY_OR_OTHER_LEGACY||KM Event-free survival estimate|0.886|||||TWO_SIDED|95.0|0.82|0.953||||||||0.953|0.820|
70862459|NCT00145600|141211764|SUPERIORITY_OR_OTHER_LEGACY||KM event-free survival estimate|0.844|||||TWO_SIDED|95.0|0.739|0.95||||||||0.950|0.739|
70862460|NCT00145600|141211764|SUPERIORITY_OR_OTHER_LEGACY||KM event-free survival estimate|0.667|||||TWO_SIDED|95.0|0.4|0.933||||||||0.933|0.400|
70862461|NCT00145600|141211764|SUPERIORITY_OR_OTHER_LEGACY||KM event-free survival estimate|0.793|||||TWO_SIDED|95.0|0.726|0.86||||||||0.860|0.726|
70862462|NCT00145600|141211765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3097||95.0|||||Wilcoxon signed rank test|||||||0.3097
70862463|NCT00145600|141211765|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.6|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862464|NCT00145600|141211765|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
70862465|NCT00145600|141211765|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.5|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71134743|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
70862466|NCT00145600|141211765|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
70862467|NCT00145600|141211765|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.37|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862468|NCT00145600|141211765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0197||95.0|||||Wilcoxon signed rank test|||||||0.0197
70862469|NCT00145600|141211765|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.51|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862470|NCT00145600|141211766|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
70862471|NCT00145600|141211766|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.46|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862472|NCT00145600|141211766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||Wilcoxon signed rank test|||||||0.0001
70862473|NCT00145600|141211766|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.41|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862474|NCT00145600|141211766|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
70862475|NCT00145600|141211766|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.42|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862476|NCT00145600|141211766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3624||95.0|||||Wilcoxon signed rank test|||||||0.3624
70862477|NCT00145600|141211766|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.52|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862478|NCT00145600|141211767|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0254||95.0|||||Wilcoxon signed rank test|||||||0.0254
70862479|NCT00145600|141211767|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.44|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862480|NCT00145600|141211767|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004||95.0|||||Wilcoxon signed rank test|||||||0.0004
70862481|NCT00145600|141211767|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.32||||0.0001||95.0|||||Spearman Correlation Coefficients|||||||0.0001
70862482|NCT00145600|141211767|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon Correlation Coefficients|||||||<0.0001
70862483|NCT00145600|141211767|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.39|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862484|NCT00145600|141211767|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014||95.0|||||Wilcoxon signed rank test|||||||0.0014
70862485|NCT00145600|141211767|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.26||||0.0061||95.0|||||Spearman Correlation Coefficients|||||||0.0061
70862486|NCT00145600|141211768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0687||95.0|||||Wilcoxon signed rank test|||||||0.0687
71134744|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.34|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.34
71134745|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71134746|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.87|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.87
70862487|NCT00145600|141211768|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.65|||<|0.0001||95.0|||||Spearman Correlation Coefficient|||||||<0.0001
70862488|NCT00145600|141211768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9478||95.0|||||Wilcoxon signed rank test|||||||0.9478
70862489|NCT00145600|141211768|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.42|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862490|NCT00145600|141211768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2999||95.0|||||Wilcoxon signed rank test|||||||0.2999
70862491|NCT00145600|141211768|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.49|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862492|NCT00145600|141211768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3121||95.0|||||Wilcoxon signed rank test|||||||0.3121
71134747|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.35|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.35
71134748|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.84|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.84
70862493|NCT00145600|141211768|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.52|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862494|NCT00145600|141211769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014||95.0|||||Wilcoxon signed rank test|||||||0.0014
70862495|NCT00145600|141211769|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.57|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862496|NCT00145600|141211769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0282||95.0|||||Wilcoxon signed rank test|||||||0.0282
71134749|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.64|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.64
70947909|NCT02641587|141396719|OTHER|"The analysis will test if the geometric LS mean level of Total NNAL for CHTP is lower than for CC. The following hypothesis will be evaluated:~H0: XCHTP - XCC ≤ 0.0~HA: XCHTP - XCC \> 0.0~where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test)."|LS Mean Reduction|79.36|||<|0.001|TWO_SIDED|95.0|72.73|84.39||The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|Generalized linear model||Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC \[%\]), and their 95% CI.|Analysis will be conducted on the natural log scale. The Day 5 levels of Total NNAL will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of Total NNAL.||84.39|72.73|<0.001
71134750|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
71134751|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
71134752|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
71134753|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
71134754|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
71134755|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
71134756|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71134757|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71134758|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
71134759|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.9|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.90
71134760|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
71134761|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71134762|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
71134763|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71134764|NCT01128426|141772111|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71134765|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71134766|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
71134767|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.34|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.34
71134768|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.54|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.54
71134769|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71134770|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71134771|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71134772|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71134773|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71134774|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.57|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.57
71134775|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
71134776|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
70862497|NCT00145600|141211769|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.35||||0.0002||95.0|||||Spearman Correlation Coefficients|||||||0.0002
71134777|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
70862498|NCT00145600|141211769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0038||95.0|||||Wilcoxon signed rank test|||||||0.0038
71134778|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71134779|NCT01128426|141772111|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71134780|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
71134781|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.22|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.22
70862499|NCT00145600|141211769|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.43|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862500|NCT00145600|141211769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1474||95.0|||||Wilcoxon signed rank test|||||||0.1474
70862501|NCT00145600|141211769|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.49|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862502|NCT00145600|141211770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0281||95.0|||||Wilcoxon signed rank test|||||||0.0281
70862503|NCT00145600|141211770|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.63|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862504|NCT00145600|141211770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0|||||Wilcoxon signed rank test|||||||0.0050
70862505|NCT00145600|141211770|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.45|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862506|NCT00145600|141211770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||95.0|||||Wilcoxon signed rank test|||||||0.0005
70862507|NCT00145600|141211770|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.37||||0.0001||95.0|||||Spearman Correlation Coefficients|||||||0.0001
70862508|NCT00145600|141211770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0552||95.0|||||Wilcoxon signed rank test|||||||0.0552
70862509|NCT00145600|141211770|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.54|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862510|NCT00145600|141211771|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
70862511|NCT00145600|141211771|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.53|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862512|NCT00145600|141211771|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxan signed rank test|||||||<0.0001
70862513|NCT00145600|141211771|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.68|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862514|NCT00145600|141211771|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017||95.0|||||Wilcoxon signed rank test|||||||0.0017
70862515|NCT00145600|141211771|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.5|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862516|NCT00145600|141211772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2758||95.0|||||Wilcoxon signed rank test|||||||0.2758
70862517|NCT00145600|141211772|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.6|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862518|NCT00145600|141211772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1731||95.0|||||Wilcoxon signed rank test|||||||0.1731
70862519|NCT00145600|141211772|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.6|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862520|NCT00145600|141211772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0846||95.0|||||Wilcoxon signed rank test|||||||0.0846
70862521|NCT00145600|141211772|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.46|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862522|NCT00145600|141211773|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4263||95.0|||||Wilcoxon signed rank test|||||||0.4263
70862523|NCT00145600|141211773|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.51|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862524|NCT00145600|141211773|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
70862525|NCT00145600|141211773|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.54|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862526|NCT00145600|141211773|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0468||95.0|||||Wilcoxon signed rank test|||||||0.0468
70862527|NCT00145600|141211773|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.55|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862528|NCT00145600|141211774|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
70862529|NCT00145600|141211774|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.26||||0.0019||95.0|||||Spearman Correlation Coefficients|||||||0.0019
70862530|NCT00145600|141211774|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
70862531|NCT00145600|141211774|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.16||||0.0704||95.0|||||Spearman Correlation Coefficients|||||||0.0704
70862532|NCT00145600|141211774|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||Wilcoxon signed rank test|||||||0.0200
70862533|NCT00145600|141211774|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.42|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862534|NCT00145600|141211775|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7192||95.0|||||Wilcoxon signed rank test|||||||0.7192
70862535|NCT00145600|141211775|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.42|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862536|NCT00145600|141211775|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8663||95.0|||||Wilcoxon signed rank test|||||||0.8663
70862537|NCT00145600|141211775|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.41|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862538|NCT00145600|141211775|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7626||95.0|||||Wilcoxon signed rank test|||||||0.7626
70862539|NCT00145600|141211775|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.58|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862540|NCT00145600|141211776|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4807||95.0|||||Wilcoxon signed rank test|||||||0.4807
70862541|NCT00145600|141211776|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.36|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862542|NCT00145600|141211776|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0824||95.0|||||Wilcoxon signed rank test|||||||0.0824
70862543|NCT00145600|141211776|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.39|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862544|NCT00145600|141211776|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0496||95.0|||||Wilcoxon signed rank test|||||||0.0496
70862545|NCT00145600|141211776|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.5|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862546|NCT00145600|141211777|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0157||95.0|||||Wilcoxon signed rank test|||||||0.0157
70862547|NCT00145600|141211777|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.37|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862548|NCT00145600|141211777|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014||95.0|||||Wilcoxon signed rank test|||||||0.0014
70862549|NCT00145600|141211777|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.43|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862550|NCT00145600|141211777|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1478||95.0|||||Wilcoxon signed rank test|||||||0.1478
70862551|NCT00145600|141211777|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.56|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862552|NCT00145600|141211778|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0831||95.0|||||Wilcoxon signed rank test|||||||0.0831
70862553|NCT00145600|141211778|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.25||||0.0027||95.0|||||Spearman Correlation Coefficients|||||||0.0027
70947910|NCT01165177|141396720|OTHER|Criteria for the vaccine efficacy (VE) objective of herpes zoster subunit (HZ/su) vaccine against herpes zoster (HZ) disease, in the 50-59 YOA strata : The lower limit (LL) of the two-sided 95% confidence interval (CI) of VE had to be above 10%.|Vaccine efficacy|96.6|||<|0.0001|TWO_SIDED|95.0|89.6|99.3||Two sided exact P-value conditional to number of cases.|Poisson exact test|||Comparison of vaccine efficacy in prevention of HZ between GSK1437173A 50-59 YOA group and placebo 50-59 YOA group||99.3|89.6|<0.0001
70947911|NCT01165177|141396720|OTHER|Criteria for the VE objective of HZ/su vaccine against herpes zoster disease, in the 60-69 YOA strata : The lower limit (LL) of the two-sided 95% confidence interval (CI) of VE had to be above 10%.|Vaccine efficacy|97.4|||<|0.0001|TWO_SIDED|95.0|90.1|99.7||Two sided exact P-value conditional to number of cases.|Poisson exact test|||Comparison of vaccine efficacy in prevention of HZ between GSK1437173A over 60-69 YOA group and placebo over 60-69 YOA group||99.7|90.1|<0.0001
71134782|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
71134783|NCT01128426|141772112|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71134784|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71134785|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
71134786|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71134787|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
71134788|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
71134789|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.58|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.58
71134790|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.57|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.57
71134791|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.39|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.39
71134792|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.87|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.87
71134793|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
71134794|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
71134795|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
71134796|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.71|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.71
71134797|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
71134798|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71134799|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.32|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.32
71134800|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.71|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.71
71134801|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.76|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.76
71134802|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.29|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.29
71134803|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.58|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.58
71134804|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.92|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.92
71134805|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
71134806|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71134807|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71134808|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71134809|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71134810|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
71134811|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71134812|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
71134813|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
71134814|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
71134815|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.35|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.35
70862554|NCT00145600|141211778|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0135||95.0|||||Wilcoxon signed rank test|||||||0.0135
71134816|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71134817|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.3|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.30
71134818|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.34|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.34
71134819|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71134820|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
71134821|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71134822|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71134823|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71134824|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
71134825|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
71134826|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
71134827|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.76|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.76
71134828|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.54|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.54
71134829|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71134830|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
71134831|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71134832|NCT01128426|141772112|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71134833|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0 .63
71134834|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
71134835|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
71134836|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.6|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.60
71134837|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
71134838|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71134839|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
71134840|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
71134841|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71134842|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.11|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.11
71134843|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.53|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.53
71134844|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71134845|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
70862555|NCT00145600|141211778|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.27||||0.0024||95.0|||||Spearman Correlation Coefficients|||||||0.0024
70862556|NCT00145600|141211778|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9848||95.0|||||Wilcoxon signed rank test|||||||0.9848
70862557|NCT00145600|141211778|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.16||||0.0974||95.0|||||Spearman Correlation Coefficients|||||||0.0974
70862558|NCT00145600|141211779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0|||||Wilcoxon signed rank test|||||||0.0040
70862559|NCT00145600|141211779|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.43|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862560|NCT00145600|141211779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012||95.0|||||Wilcoxon signed rank test|||||||0.0012
70862561|NCT00145600|141211779|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.54|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862562|NCT00145600|141211779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8108||95.0|||||Wilcoxon signed rank test|||||||0.8108
70862563|NCT00145600|141211779|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.55|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
70862564|NCT00145600|141211780|SUPERIORITY_OR_OTHER_LEGACY||KM Event-free survival estimate|0.874|||||TWO_SIDED|95.0|0.805|0.944||||||||0.944|0.805|
70862565|NCT00145600|141211780|SUPERIORITY_OR_OTHER_LEGACY||KM event-free survival estimate|0.844|||||TWO_SIDED|95.0|0.739|0.95||||||||0.950|0.739|
70862566|NCT00145600|141211780|SUPERIORITY_OR_OTHER_LEGACY||KM event-free survival estimate|0.667|||||TWO_SIDED|95.0|0.4|0.933||||||||0.933|0.400|
70862567|NCT00145600|141211780|SUPERIORITY_OR_OTHER_LEGACY||KM event-free survival estimate|0.785|||||TWO_SIDED|95.0|0.716|0.853||||||||0.853|0.716|
70862568|NCT01539642|141211786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.02|STANDARD_ERROR_OF_MEAN|15.25||0.001|TWO_SIDED|95.0|19.89|80.14|||ANCOVA|||||80.14|19.89|0.001
70862569|NCT02600351|141211810|NON_INFERIORITY|With a 10% non-inferiority margin, a sample size of 90 participants per treatment group was required to provide at least 90% power to establish non-inferiority at the 1-sided 0.025 level, assuming the SVR12 rates were 98% for both groups.|Difference in percentages|-18.8||||0.065|TWO_SIDED|95.0|-40.7|3.2|||Cochran-Mantel-Haenszel|||||3.2|-40.7|0.065
70862570|NCT02600351|141211810|NON_INFERIORITY|With a 10% non-inferiority margin, a sample size of 125 participants per treatment group was required to provide at least 90% power to establish non-inferiority at the 1-sided 0.025 level, assuming the SVR12 rates were 95% for both groups.|Difference in percentages|-11.7||||0.25|TWO_SIDED|95.0|-32.1|8.8|||Cochran-Mantel-Haenszel|||||8.8|-32.1|0.25
70862571|NCT01859143|141211825|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified equivalence criterion for fever within 7 days of vaccination mentioned that the upper limit of 95 percent (%) confidence interval (CI) for difference in percentage of participants with fever \>=101 degrees F should be less than 5 percentage points.|Percent difference|0.4|||||TWO_SIDED|95.0|-5.3|2.6|||||A two-sided 95% CI was constructed using the exact method based on the score statistic proposed by Chan and Zhang.|||2.6|-5.3|
71134846|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
70862572|NCT01859143|141211826|SUPERIORITY_OR_OTHER||Percent difference|11.9|||||TWO_SIDED|95.0|-1.9|23.9|||||Any symptom within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||23.9|-1.9|
70862573|NCT01859143|141211826|SUPERIORITY_OR_OTHER||Percent difference|0.8|||||TWO_SIDED|95.0|-4.9|3.3|||||Fever \>100 degrees F within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||3.3|-4.9|
70862574|NCT01859143|141211826|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-6.1|1.8|||||Fever \>102 degrees F within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||1.8|-6.1|
70862575|NCT01859143|141211826|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-6.1|1.8|||||Fever \>103 degrees F within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||1.8|-6.1|
70862576|NCT01859143|141211826|SUPERIORITY_OR_OTHER||Percent difference|8.9|||||TWO_SIDED|95.0|-2.6|17.7|||||Runny nose within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||17.7|-2.6|
70862577|NCT01859143|141211826|SUPERIORITY_OR_OTHER||Percent difference|6.2|||||TWO_SIDED|95.0|-2.2|11.6|||||Sore throat within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||11.6|-2.2|
70862578|NCT01859143|141211826|SUPERIORITY_OR_OTHER||Percent difference|-0.5|||||TWO_SIDED|95.0|-9.3|4.7|||||Cough within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||4.7|-9.3|
70862579|NCT01859143|141211826|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-6.1|1.8|||||Vomiting within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||1.8|-6.1|
70862580|NCT01859143|141211826|SUPERIORITY_OR_OTHER||Percent difference|-0.1|||||TWO_SIDED|95.0|-8.0|4.3|||||Muscle aches within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||4.3|-8.0|
70862581|NCT01859143|141211826|SUPERIORITY_OR_OTHER||Percent difference|1.7|||||TWO_SIDED|95.0|-4.1|4.4|||||Chills within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||4.4|-4.1|
70862582|NCT01859143|141211826|SUPERIORITY_OR_OTHER||Percent difference|3.2|||||TWO_SIDED|95.0|-6.5|9.8|||||Decreased activity (tiredness) within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||9.8|-6.5|
70862583|NCT01859143|141211826|SUPERIORITY_OR_OTHER||Percent difference|3.5|||||TWO_SIDED|95.0|-7.8|11.9|||||Headache within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||11.9|-7.8|
70862584|NCT01859143|141211826|SUPERIORITY_OR_OTHER||Percent difference|12.3|||||TWO_SIDED|95.0|-1.6|24.4|||||Any symptom within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||24.4|-1.6|
70862585|NCT01859143|141211826|SUPERIORITY_OR_OTHER||Percent difference|1.2|||||TWO_SIDED|95.0|-4.5|3.9|||||Fever \>100 degrees F within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||3.9|-4.5|
70862586|NCT01859143|141211826|SUPERIORITY_OR_OTHER||Percent difference|0.8|||||TWO_SIDED|95.0|-4.9|3.3|||||Fever \>=101 degrees F within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||3.3|-4.9|
70862587|NCT01859143|141211826|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-6.1|1.8|||||Fever \>102 degrees F within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||1.8|-6.1|
70862588|NCT01859143|141211826|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-6.1|1.8|||||Fever \>103 degrees F within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||1.8|-6.1|
70862589|NCT01859143|141211826|SUPERIORITY_OR_OTHER||Percent difference|9.7|||||TWO_SIDED|95.0|-1.8|18.6|||||Runny nose within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||18.6|-1.8|
70862590|NCT01859143|141211826|SUPERIORITY_OR_OTHER||Percent difference|4.4|||||TWO_SIDED|95.0|-5.3|11.2|||||Sore throat within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||11.2|-5.3|
70862591|NCT01859143|141211826|SUPERIORITY_OR_OTHER||Percent difference|0.3|||||TWO_SIDED|95.0|-8.6|5.7|||||Cough within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||5.7|-8.6|
70862592|NCT01859143|141211826|SUPERIORITY_OR_OTHER||Percent difference|0.4|||||TWO_SIDED|95.0|-5.3|2.6|||||Vomiting within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||2.6|-5.3|
70862593|NCT01859143|141211826|SUPERIORITY_OR_OTHER||Percent difference|0.3|||||TWO_SIDED|95.0|-7.8|4.8|||||Muscle aches within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||4.8|-7.8|
70862594|NCT01859143|141211826|SUPERIORITY_OR_OTHER||Percent difference|2.5|||||TWO_SIDED|95.0|-3.3|5.5|||||Chills within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||5.5|-3.3|
70862595|NCT01859143|141211826|SUPERIORITY_OR_OTHER||Percent difference|4.4|||||TWO_SIDED|95.0|-5.3|11.2|||||Decreased activity (tiredness) within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||11.2|-5.3|
70862596|NCT01859143|141211826|SUPERIORITY_OR_OTHER||Percent difference|3.0|||||TWO_SIDED|95.0|-8.7|12.0|||||Headache within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||12.0|-8.7|
70862597|NCT00438451|141211830|SUPERIORITY_OR_OTHER|||||||0.0201||95.0|||||Fisher Exact|||||||0.0201
70862598|NCT00438451|141211830|SUPERIORITY_OR_OTHER|||||||0.1536||95.0|||||Fisher Exact|||||||0.1536
70862599|NCT00438451|141211830|SUPERIORITY_OR_OTHER|||||||0.3615||95.0|||||Fisher Exact|||||||0.3615
70862600|NCT00438451|141211830|SUPERIORITY_OR_OTHER|||||||0.0478||95.0|||||Fisher Exact|||||||0.0478
70862601|NCT00438451|141211830|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.838||||0.0578|TWO_SIDED|95.0|1.092|3.093|||Regression, Logistic|adjusted for treatment (p=0.0578), country (p=0.4649), pooled sites (p=0.4420) and number of concurrent diseases (p=0.0192)|"Odds ratio given here is for comparison LEV vs CBZ: OR=1.838 KI=(1.092-3.093) LEV vs LTG: OR=1.169 KI=(0.689-1.984) CBZ vs LTG: OR=0.636 KI=(0.377-1.073) Number of concurrent diseases: OR=0.921 KI=(0.859-0.987)"|||3.093|1.092|0.0578
70947912|NCT01165177|141396720|OTHER|Criteria for the VE objective of HZ/su vaccine against herpes zoster disease, in the 70-79 YOA strata : The lower limit (LL) of the two-sided 95% confidence interval (CI) of VE had to be above 10%.|Vaccine efficacy|97.9||||0.0001|TWO_SIDED|95.0|87.9|100.0||Two sided exact P-value conditional to number of cases.|Poisson exact test|||Comparison of vaccine efficacy in prevention of HZ between GSK1437173A over 70 YOA group and placebo over 70 YOA group||100|87.9|0.0001
70862602|NCT00438451|141211831|SUPERIORITY_OR_OTHER|||||||0.0596||95.0|||||Log Rank|||||||0.0596
70862603|NCT00438451|141211832|SUPERIORITY_OR_OTHER|||||||0.2517||95.0|||||Fisher Exact|||||||0.2517
70862604|NCT00438451|141211833|SUPERIORITY_OR_OTHER|||||||0.3303||95.0|||||Fisher Exact|||||||0.3303
70862605|NCT00438451|141211834|SUPERIORITY_OR_OTHER|||||||0.5022||95.0|||||Log Rank|||||||0.5022
70862606|NCT02413372|141211842|SUPERIORITY||Mean Difference (Final Values)|-7.17|||||TWO_SIDED|90.0|-9.09|-5.26|||||mean difference in adjusted change from baseline vs placebo|Day 57||-5.26|-9.09|
70862607|NCT02413372|141211842|SUPERIORITY||Mean Difference (Final Values)|-5.19|||||TWO_SIDED|90.0|-7.14|-3.25|||||mean difference in adjusted change from baseline vs placebo|Day 57||-3.25|-7.14|
70862608|NCT02413372|141211842|SUPERIORITY||Mean Difference (Final Values)|-5.43||||0.0004|TWO_SIDED|90.0|-8.01|-2.84|||t-test, 1 sided||mean difference in adjusted change from baseline vs placebo|Day 112||-2.84|-8.01|0.0004
71134847|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.53|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.53
70862609|NCT02413372|141211842|SUPERIORITY||Mean Difference (Final Values)|-3.85||||0.0084|TWO_SIDED|90.0|-6.47|-1.23|||t-test, 1 sided||mean difference in adjusted change from baseline vs placebo|Day 112||-1.23|-6.47|0.0084
70862610|NCT02556203|141211858|NON_INFERIORITY|1-sided Confidence interval|Hazard Ratio (HR)|1.2089302|||||ONE_SIDED|97.5||1.7040824||||||"H0: HR(t)\>=1.20 for all time points t\>=0, (i.e. the hazard for the primary efficacy endpoint in the rivaroxaban-based treatment group is more than 20% larger than that in the antiplatelet-based control group)"||1.7040824||
70862611|NCT02556203|141211859|SUPERIORITY|2-sided Log Rank test|Hazard Ratio (HR)|1.35|||=|0.04223|TWO_SIDED|95.0|1.01|1.81|||Log Rank|||||1.81|1.01|= 0.04223
70862612|NCT02556203|141211860|OTHER|Descriptive. 2-sided Log Rank test.|Hazard Ratio (HR)|1.5|||=|0.07745|TWO_SIDED|95.0|0.95|2.37|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.|||2.37|0.95|= 0.07745
70862613|NCT02556203|141211861|SUPERIORITY|2-sided Log Rank test|Hazard Ratio (HR)|1.39|||=|0.01156|TWO_SIDED|95.0|1.08|1.8|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.|||1.80|1.08|= 0.01156
71134848|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
70862614|NCT02556203|141211862|SUPERIORITY|2-sided Log Rank test|Hazard Ratio (HR)|1.22|||=|0.21595|TWO_SIDED|95.0|0.89|1.69|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.|||1.69|0.89|= 0.21595
70862615|NCT02556203|141211863|OTHER|Descriptive. 2-sided Log Rank test.|Hazard Ratio (HR)|1.78|||=|0.02216|TWO_SIDED|95.0|1.08|2.94|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.|||2.94|1.08|= 0.02216
70862616|NCT02556203|141211864|OTHER|Descriptive. 2-sided Log Rank test.|Hazard Ratio (HR)|1.66|||=|0.02702|TWO_SIDED|95.0|1.05|2.62|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.|||2.62|1.05|= 0.02702
70862617|NCT02556203|141211865|OTHER|Descriptive. 2-sided Log Rank test.|Hazard Ratio (HR)|1.84|||=|1e-05|TWO_SIDED|95.0|1.41|2.41|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.|||2.41|1.41|= 0.00001
70862618|NCT01925274|141211899|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-35.71||||0.164|TWO_SIDED|95.0|-83.4|12.0|||Chi-squared|||||12.0|-83.4|0.164
70862619|NCT00580970|141211957|SUPERIORITY_OR_OTHER|||||||0.9138||||||Considering all late rectal toxicities, 38% (20/53) of participants developed physician reported Grade 2 or higher GI toxicity during 2 year follow up. The threshold for significance was p \< 0.05.|t-test, 1 sided|A one sided t-test, with 5% level of significance, and 83% power was used which required 53 subjects.||||||0.9138
70862620|NCT00568685|141211998|SUPERIORITY_OR_OTHER|||||||0.0048||95.0||||This is the p value for CGI-ADHD-S score change at endpoint|Mixed Models Analysis|||||||0.0048
70862621|NCT00568685|141211999|SUPERIORITY_OR_OTHER|||||||0.0153||95.0||||This is the p value for CGI-ADHD-I score change at endpoint|Mixed Models Analysis|||||||0.0153
70862622|NCT00568685|141212000|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||P-value relates to the sum of adverse events leading to discontinuation.|Fisher Exact|||||||.4500
70862623|NCT00568685|141212001|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||ANCOVA|||||||0.0240
70862624|NCT00568685|141212003|SUPERIORITY_OR_OTHER|||||||0.8005||95.0||||This is the p value for heart rate change at endpoint|ANOVA|||||||0.8005
70862625|NCT00568685|141212004|SUPERIORITY_OR_OTHER|||||||0.4128||95.0||||This is the p value for temperature change at endpoint|ANOVA|||||||0.4128
70947913|NCT01165177|141396720|OTHER|Criteria for the VE objective of HZ/su vaccine against herpes zoster disease, in the overall age strata : The lower limit (LL) of the two-sided 95% confidence interval (CI) of VE had to be above 10%.|Vaccine efficacy|97.2|||<|0.0001|TWO_SIDED|95.0|93.7|99.0||Two sided exact P-value conditional to number of cases.|Poisson exact test|||Comparison of vaccine efficacy in prevention of HZ between GSK1437173A overall ages group and placebo overall ages group||99|93.7|<0.0001
70862626|NCT00568685|141212005|SUPERIORITY_OR_OTHER|||||||0.9761||95.0||||This is the p value for systolic change at endpoint|ANOVA|||||||0.9761
70862627|NCT00568685|141212005|SUPERIORITY_OR_OTHER|||||||0.6419||95.0||||This is the p value for diastolic change at endpoint|ANOVA|||||||0.6419
70862628|NCT00568685|141212006|SUPERIORITY_OR_OTHER|||||||0.2213||95.0||||This is the p value for weight change at endpoint|ANOVA|||||||0.2213
70862629|NCT02787551|141212015|SUPERIORITY||Least square (LS) mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001|TWO_SIDED|95.0|-0.77|-0.508||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using Mixed-effect model with repeated measures (MMRM) with treatment groups, randomization strata of Week -2 HbA1c (\<8.0%, \>=8.0%), GLP-1 RA subtype at screening, visits, treatment-by-visit interaction, world region as fixed effects, baseline HbA1c value-by-visit interaction as a covariate. Analysis included all scheduled measurements obtained during 26-week randomized treatment period, including those obtained after IMP discontinuation/introduction of rescue medication.||-0.508|-0.770|<0.0001
70862630|NCT02787551|141212017|SUPERIORITY||Difference in percentage|36.05|||<|0.0001|TWO_SIDED|95.0|28.11|43.99||Threshold for significance \<=0.05|Cochran-Mantel-Haenszel|||HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs GLP-1 Receptor Agonist. Analysis was performed using Cochran-Mantel-Haenszel method method stratified on randomization strata of Week -2 HbA1c (\<8.0%, \>=8.0%), and randomization strata of GLP-1 receptor agonist subtype at screening. Hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially per pre-specified order (only HbA1c \< 7% was part of testing).||43.99|28.11|<.0001
70862631|NCT02787551|141212019|SUPERIORITY||LS Mean Difference|-1.67|STANDARD_ERROR_OF_MEAN|0.168|<|0.0001|TWO_SIDED|95.0|-2.001|-1.341||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM with treatment groups, randomization strata of Week -2 HbA1c (\<8.0%, \>=8.0%), randomization strata of GLP-1 RA subtype at screening, scheduled visit, treatment-by-visit interaction, and world region as fixed effects, and and baseline FPG value-by visit interaction as a covariate. Testing according to the hierarchical testing procedure (continued only if previous outcome measures were statistically significant).||-1.341|-2.001|<0.0001
70862632|NCT02787551|141212021|SUPERIORITY||LS Mean Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.157|<|0.0001|TWO_SIDED|95.0|-1.325|-0.708||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM with treatment groups, randomization strata of Week -2 HbA1c (\<8.0%, \>=8.0%), randomization strata of GLP-1 RA subtype at screening, scheduled visit, treatment-by-visit interaction, and world region as fixed effects, and baseline average SMPG value-by-visit interaction as a covariate. Testing according to the hierarchical testing procedure (continued only if previous outcome measures were statistically significant).||-0.708|-1.325|<0.0001
70862633|NCT02787551|141212023|SUPERIORITY||LS Mean Difference|-2.85|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|-3.42|-2.279||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of Week -2 HbA1c (\<8.0%, \>=8.0%), randomization strata of GLP-1 RA subtype (once/twice daily formulations, once weekly formulations) at screening, and world region as fixed effects and baseline 2-hour PPG value as a covariate. Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).||-2.279|-3.420|<0.0001
70947914|NCT01165177|141396721|OTHER|Criteria for the VE objective of HZ/su vaccine against PHN in the 50-59 YOA strata: The lower limit of the 95% CI of VE had to be above 0%|Vaccine efficacy|100.0||||0.0081|TWO_SIDED|95.0|40.9|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between GSK1437173A 50-59 YOA group and placebo 50-59 YOA group||100|40.9|0.0081
70947915|NCT01165177|141396721|OTHER|Criteria for VE objective of HZ/su vaccine against PHN in the 60-69 YOA strata: The lower limit of the 95% CI of VE had to be above 0%|Vaccine efficacy|100.0||||0.5097|TWO_SIDED|95.0|-442.8|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between GSK1437173A 60-69 YOA group and placebo 60-69 YOA group||100|-442.8|0.5097
71134849|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.36|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.36
71134850|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
71134851|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
71134852|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.81|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.81
71134853|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.75|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.75
71134854|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
71134855|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
71134856|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71134857|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71134858|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.37|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.37
71134859|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.12|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.12
71134860|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
70947916|NCT01165177|141396721|OTHER|Criteria for the VE objective of HZ/su vaccine against PHN in the 70-79 YOA strata: The lower limit of the 95% CI of VE had to be above 0%|Vaccine efficacy|100.0||||0.0078|TWO_SIDED|95.0|41.4|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between GSK1437173A over 70 YOA group and placebo over 70 YOA group||100|41.4|0.0078
71134861|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
71134862|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
71134863|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.78|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.78
71134864|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.84|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.84
71134865|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.44|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.44
71134866|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71134867|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
71134868|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
71134869|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71134870|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
70872158|NCT01438957|141229570|SUPERIORITY||||||<|0.001|||||||Log Rank|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||<0.001
70947917|NCT01165177|141396721|OTHER|Criteria for the VE objective of HZ/su vaccine against PHN in the overall ages strata: The lower limit of the 95% CI of VE had to be above 0%|Vaccine efficacy|100.0|||<|0.0001|TWO_SIDED|95.0|77.1|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between GSK1437173A overall ages group and placebo overall ages group||100|77.1|<0.0001
70947918|NCT01663506|141396748|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 3||||<0.01
70947919|NCT01663506|141396748|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.01
70862634|NCT02787551|141212025|SUPERIORITY||LS Mean Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.244|<|0.0001|TWO_SIDED|95.0|-1.468|-0.508||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -2 HbA1c (\<8.0%, \>=8.0%), randomization strata of GLP-1 receptor agonist subtype (once/twice daily formulations, once weekly formulations) at screening, and world region as fixed effects and baseline 2-hour plasma glucose excursion value as a covariate. Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).||-0.508|-1.468|<0.0001
70862635|NCT00704912|141212131|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.5||||0.06|TWO_SIDED|95.0|1.0|6.6|||Log-binomial model|||||6.6|1.0|0.06
70862636|NCT00704912|141212131|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.3||||0.08|TWO_SIDED|95.0|0.9|6.1|||Log-binomial model|||||6.1|0.9|0.08
70862637|NCT00704912|141212131|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.82|TWO_SIDED|95.0|0.5|2.1|||Log-binomial model|||||2.1|0.5|0.82
70862638|NCT00704912|141212132|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.06|TWO_SIDED|95.0|1.0|1.7|||Log-binomial model|||||1.7|1.0|0.06
70862639|NCT00704912|141212132|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.5||||0.002|TWO_SIDED|95.0|1.1|1.9|||Log-binomial model|||||1.9|1.1|0.002
70862640|NCT00704912|141212132|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9||||0.28|TWO_SIDED|95.0|0.7|1.1|||Log-binomial model|||||1.1|0.7|0.28
70862641|NCT00704912|141212133|SUPERIORITY_OR_OTHER||Difference in Mean Change|-5.0|||<|0.0001|TWO_SIDED|95.0|-6.3|-3.8|||Mixed Models Analysis||Lifestyle vs. OCP|||-3.8|-6.3|<.0001
70862642|NCT00704912|141212133|SUPERIORITY_OR_OTHER||Difference in Mean Change|-5.0|||<|0.0001|TWO_SIDED|95.0|-6.2|-3.7|||Mixed Models Analysis||Combined vs. OCP|||-3.7|-6.2|<.0001
70862643|NCT00704912|141212133|SUPERIORITY_OR_OTHER||Difference in Mean Change|-0.1||||0.92|TWO_SIDED|95.0|-1.3|1.2|||Mixed Models Analysis||Lifestyle vs. Combined|||1.2|-1.3|0.92
70862644|NCT00704912|141212134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.6|TWO_SIDED|95.0|0.6|2.2|||GEE||End of intervention compared to baseline.|Comparing change in prevalence of metabolic syndrome from baseline to the end of intervention.||2.2|0.6|0.60
70862645|NCT00704912|141212134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.001|TWO_SIDED|95.0|1.4|4.3|||GEE||End of intervention compared to baseline|Comparing change in prevalence of metabolic syndrome from baseline to the end of intervention.||4.3|1.4|0.001
70862646|NCT00704912|141212134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.18|TWO_SIDED|95.0|0.4|1.2|||GEE||End of intervention compared to baseline|Comparing change in prevalence of metabolic syndrome from baseline to the end of intervention.||1.2|0.4|0.18
70862647|NCT00704912|141212134|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||GEE|||||||0.08
70862648|NCT00704912|141212134|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||GEE|||||||0.001
70862649|NCT00704912|141212134|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||GEE|||||||0.22
70862650|NCT02349061|141212140|SUPERIORITY||Odds Ratio (OR)|3.28||||0.0057|TWO_SIDED|95.0|1.41|7.63|||Regression, Logistic|||||7.63|1.41|0.0057
70862651|NCT02349061|141212141|SUPERIORITY||Least Squares (LS) Mean Difference|-1.36||||0.0929|TWO_SIDED|95.0|-2.94|0.23|||Mixed model repeated measures model|||||0.23|-2.94|0.0929
70862652|NCT02349061|141212142|SUPERIORITY||LS Means Difference|-0.383||||0.3944|TWO_SIDED|95.0|-1.271|0.506|||Mixed model repeated measures model|||||0.506|-1.271|0.3944
70862653|NCT02349061|141212143|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9939|TWO_SIDED|95.0|0.43|2.34|||Regression, Logistic|||||2.34|0.43|0.9939
70862654|NCT02349061|141212144|SUPERIORITY||LS Means Difference|-2.17||||0.1032|TWO_SIDED|95.0|-4.78|0.45|||Mixed model repeated measures model|||||0.45|-4.78|0.1032
70862655|NCT00537238|141212151|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the difference in proportion (Pregabalin - Levetiracetam) was greater than -0.12.|Difference in Proportion|0.0|||||TWO_SIDED|90.0|-0.08|0.09||||||||0.09|-0.08|
70862656|NCT00537238|141212152|SUPERIORITY_OR_OTHER_LEGACY||Median difference|4.1||||0.3571|TWO_SIDED|95.0|-2.6|10.9|||Ranked ANCOVA|||Rank analysis of covariance (ANCOVA) model was used to derive p-value with treatment as main effect and cluster as cofactor, percent change in 28-day seizure counts between baseline and treatment periods as dependent variable. Median differences and 95% confidence interval (CI) were based on Hodges-Lehmann estimation.||10.9|-2.6|0.3571
70862657|NCT00537238|141212154|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0822|TWO_SIDED||||||Fisher Exact|||All partial seizure: p-value was calculated from the 2-sided Fisher's exact test.||||0.0822
70862658|NCT00537238|141212154|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9175|TWO_SIDED||||||Fisher Exact|||Simple partial seizure: p-value was calculated from the 2-sided Fisher's exact test.||||0.9175
70862659|NCT00537238|141212154|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0483|TWO_SIDED||||||Fisher Exact|||Complex partial seizure: p-value was calculated from the 2-sided Fisher's exact test.||||0.0483
70862660|NCT00537238|141212154|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7139|TWO_SIDED||||||Fisher Exact|||SGTC seizure: p-value was calculated from the 2-sided Fisher's exact test.||||0.7139
70862661|NCT00537238|141212155|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|1.17|STANDARD_ERROR_OF_MEAN|0.78||0.1334|TWO_SIDED|95.0|-0.36|2.69|||ANCOVA|||Baseline, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||2.69|-0.36|0.1334
70862662|NCT00537238|141212155|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.17|STANDARD_ERROR_OF_MEAN|0.18||0.3551|TWO_SIDED|95.0|-0.19|0.52|||ANCOVA|||Baseline, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.52|-0.19|0.3551
70862663|NCT00537238|141212155|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.46|STANDARD_ERROR_OF_MEAN|0.5||0.3638|TWO_SIDED|95.0|-1.45|0.53|||ANCOVA|||Change at Week 7, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.53|-1.45|0.3638
70862664|NCT00537238|141212155|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.12|STANDARD_ERROR_OF_MEAN|0.11||0.2457|TWO_SIDED|95.0|-0.34|0.09|||ANCOVA|||Change at Week 7, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.09|-0.34|0.2457
70862665|NCT00537238|141212155|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.23|STANDARD_ERROR_OF_MEAN|0.53||0.664|TWO_SIDED|95.0|-1.26|0.81|||ANCOVA|||Change at Week 10, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.81|-1.26|0.6640
71134871|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
71134872|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71134873|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
71134874|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
71134875|NCT01128426|141772113|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
71134876|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71134877|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.77|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.77
71134878|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71134879|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.55|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.55
71134880|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71134881|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.62|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.62
70862666|NCT00537238|141212155|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.06|STANDARD_ERROR_OF_MEAN|0.12||0.595|TWO_SIDED|95.0|-0.3|0.17|||ANCOVA|||Change at Week 10, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.17|-0.30|0.5950
70862667|NCT00537238|141212155|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.31|STANDARD_ERROR_OF_MEAN|0.55||0.5701|TWO_SIDED|95.0|-1.38|0.76|||ANCOVA|||Change at Week 13, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.76|-1.38|0.5701
70862668|NCT00537238|141212155|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.12|STANDARD_ERROR_OF_MEAN|0.1||0.2452|TWO_SIDED|95.0|-0.33|0.08|||ANCOVA|||Change at Week 13, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.08|-0.33|0.2452
70862669|NCT00537238|141212155|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.77|STANDARD_ERROR_OF_MEAN|0.56||0.1697|TWO_SIDED|95.0|-1.88|0.33|||ANCOVA|||Change at Week 16, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.33|-1.88|0.1697
70862670|NCT00537238|141212155|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.14|STANDARD_ERROR_OF_MEAN|0.11||0.2283|TWO_SIDED|95.0|-0.36|0.09|||ANCOVA|||Change at Week 16, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.09|-0.36|0.2283
70862671|NCT00537238|141212155|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-1.35|STANDARD_ERROR_OF_MEAN|0.61||0.0262|TWO_SIDED|95.0|-2.54|-0.16|||ANCOVA|||Change at Follow-up, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||-0.16|-2.54|0.0262
70862672|NCT00537238|141212155|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.26|STANDARD_ERROR_OF_MEAN|0.13||0.0495|TWO_SIDED|95.0|-0.52|0.0|||ANCOVA|||Change at Follow-up, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.00|-0.52|0.0495
71134882|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71134883|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71134884|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71134885|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.43|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.43
71134886|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.22|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.22
71134887|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.22|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.22
71134888|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71134889|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
71134890|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71134891|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.85|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.85
71134892|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
71134893|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
71134894|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
71134895|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
71134896|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
71134897|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
71134898|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
71134899|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
71134900|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.74|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.74
71134901|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
71134902|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71134903|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71134904|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.82|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.82
71134905|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71134906|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.55|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.55
71134907|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.26|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.26
71134908|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
70947920|NCT01663506|141396748|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.01
71134909|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.81|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.81
70862673|NCT00537238|141212156|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.09|STANDARD_ERROR_OF_MEAN|0.37||0.8084|TWO_SIDED|95.0|-0.82|0.64|||ANCOVA|||Baseline, HADS-A: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.64|-0.82|0.8084
70862674|NCT00537238|141212156|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.22|STANDARD_ERROR_OF_MEAN|0.35||0.5263|TWO_SIDED|95.0|-0.47|0.91|||ANCOVA|||Baseline, HADS-D: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.91|-0.47|0.5263
70862675|NCT00537238|141212156|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.25|STANDARD_ERROR_OF_MEAN|0.3||0.4008|TWO_SIDED|95.0|-0.34|0.85|||ANCOVA|||Week 16, HADS-A: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.85|-0.34|0.4008
70947921|NCT01663506|141396750|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.001
70947922|NCT01663506|141396750|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.0001
70947923|NCT01663506|141396751|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.05
71134910|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71134911|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
71134912|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71134913|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71134914|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.64|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.64
71134915|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.97|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.97
71134916|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.31|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.31
71134917|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71134918|NCT01128426|141772114|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
71134919|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
71134920|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.78|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.78
71134921|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method.The null hypothesis was relative risk = 1.||||0.13
71134922|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
71134923|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
71134924|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.62|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.62
71134925|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71134926|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
71134927|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
71134928|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
71134929|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
71134930|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71134931|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
70947924|NCT01663506|141396751|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.0001
70947925|NCT01663506|141396753|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.05
70872159|NCT01438957|141229570|SUPERIORITY|||||||0.001|||||||Log Rank|Stratified by the anesthesia type||||||0.001
70872160|NCT01438957|141229570|SUPERIORITY|||||||0.212|||||||Log Rank|Stratified by the anesthesia type||||||0.212
70947926|NCT01663506|141396753|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.01
70947927|NCT01663506|141396754|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.01
70947928|NCT01663506|141396756|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.001
70947929|NCT01663506|141396756|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.01
70947930|NCT01663506|141396757|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.05
70947931|NCT01663506|141396757|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.01
71134932|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71134933|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
71134934|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.12|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.12
71134935|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
71134936|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
71134937|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.61|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.61
71134938|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
71134939|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.62|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.62
71134940|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
71134941|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.66|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.66
71134942|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
71134943|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.18|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.18
71134944|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71134945|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
71134946|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71134947|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.37|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.37
71134948|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.12|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.12
71134949|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71134950|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71134951|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.82|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.82
71134952|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
71134953|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.78|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.78
71134954|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.65|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.65
71134955|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.17|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.17
71134956|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.22|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.22
71134957|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.81|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.81
71134958|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71134959|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
71134960|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
70862676|NCT00537238|141212156|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.01|STANDARD_ERROR_OF_MEAN|0.3||0.9749|TWO_SIDED|95.0|-0.61|0.59|||ANCOVA|||Week 16, HADS-D: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.59|-0.61|0.9749
71134961|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
71134962|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
71134963|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71134964|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
71134965|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.97|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.97
71134966|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.19|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.19
71134967|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71134968|NCT01128426|141772115|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
71134969|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
71134970|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
71134971|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
71134972|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
71134973|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.26|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.26
71134974|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
71134975|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.4|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.40
71134976|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.2|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.20
70862677|NCT00537238|141212157|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-1.03|STANDARD_ERROR_OF_MEAN|2.06||0.6161|TWO_SIDED|95.0|-5.08|3.01|||ANCOVA|||Baseline sleep disturbance: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||3.01|-5.08|0.6161
70862678|NCT00537238|141212157|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-1.63|STANDARD_ERROR_OF_MEAN|1.62||0.3154|TWO_SIDED|95.0|-4.83|1.56|||ANCOVA|||Week 16 sleep disturbance: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||1.56|-4.83|0.3154
70862679|NCT00537238|141212157|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-1.7|STANDARD_ERROR_OF_MEAN|3.18||0.593|TWO_SIDED|95.0|-7.94|4.54|||ANCOVA|||Baseline snoring: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||4.54|-7.94|0.5930
70862680|NCT00537238|141212157|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|10.02|STANDARD_ERROR_OF_MEAN|2.42|<|0.0001|TWO_SIDED|95.0|5.27|14.76|||ANCOVA|||Week 16 snoring: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||14.76|5.27|<0.0001
70862681|NCT00537238|141212157|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-1.54|STANDARD_ERROR_OF_MEAN|2.18||0.4807|TWO_SIDED|95.0|-5.83|2.75|||ANCOVA|||Baseline awaken short of breath: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||2.75|-5.83|0.4807
70862682|NCT00537238|141212157|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.88|STANDARD_ERROR_OF_MEAN|2.07||0.6708|TWO_SIDED|95.0|-3.18|4.94|||ANCOVA|||Week 16 awaken short of breath: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||4.94|-3.18|0.6708
70862683|NCT00537238|141212157|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7574|TWO_SIDED|95.0|-0.32|0.24|||ANCOVA|||Baseline quantity of sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||0.24|-0.32|0.7574
70862684|NCT00537238|141212157|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.14|STANDARD_ERROR_OF_MEAN|0.12||0.2615|TWO_SIDED|95.0|-0.1|0.38|||ANCOVA|||Week 16 quantity of sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||0.38|-0.10|0.2615
70947932|NCT01663506|141396759|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||SJC28: Change from Baseline at Month 6||||<0.01
71134977|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
70862685|NCT00537238|141212157|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-1.44|STANDARD_ERROR_OF_MEAN|2.53||0.5703|TWO_SIDED|95.0|-6.42|3.54|||ANCOVA|||Baseline adequacy of sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||3.54|-6.42|0.5703
70862686|NCT00537238|141212157|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-2.99|STANDARD_ERROR_OF_MEAN|2.41||0.216|TWO_SIDED|95.0|-7.74|1.75|||ANCOVA|||Week 16 adequacy of sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||1.75|-7.74|0.2160
70872161|NCT01438957|141229571|SUPERIORITY|||||||0.869|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.869
71134978|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.59|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.59
71134979|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.1|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.10
71134980|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
71134981|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
70947933|NCT01663506|141396759|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||TJC28: Change from Baseline at Month 6||||<0.01
71134982|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
71134983|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.93|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.93
70947934|NCT01663506|141396759|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wilcoxon's signed-rank test|||SJC28: Change from Baseline at Month 12||||<0.001
71134984|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.56|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.56
71134985|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.79|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.79
71134986|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.46|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.46
70862687|NCT00537238|141212157|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|1.07|STANDARD_ERROR_OF_MEAN|2.02||0.5952|TWO_SIDED|95.0|-2.89|5.03|||ANCOVA|||Baseline somnolence: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||5.03|-2.89|0.5952
70862688|NCT00537238|141212157|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.72|STANDARD_ERROR_OF_MEAN|1.87||0.6984|TWO_SIDED|95.0|-4.4|2.95|||ANCOVA|||Week 16 somnolence: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||2.95|-4.40|0.6984
70862689|NCT00537238|141212157|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.13|STANDARD_ERROR_OF_MEAN|1.64||0.9389|TWO_SIDED|95.0|-3.09|3.34|||ANCOVA|||Baseline sleep problem index (9): ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||3.34|-3.09|0.9389
70862690|NCT00537238|141212157|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.64|STANDARD_ERROR_OF_MEAN|1.34||0.6344|TWO_SIDED|95.0|-2.0|3.27|||ANCOVA|||Week 16 sleep problem index (9): ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||3.27|-2.00|0.6344
70862691|NCT00537238|141212158|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.016||||0.9285|TWO_SIDED|95.0|0.715|1.444|||Regression, Logistic|||Baseline: Logistic regression model was used to estimate odds ratio and corresponding 95% CI of treatment difference, with treatment as fixed effect and for post-baseline assessments baseline was included as a covariate.||1.444|0.715|0.9285
70862692|NCT00537238|141212158|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.432||||0.0696|TWO_SIDED|95.0|0.972|2.11|||Regression, Logistic|||Week 16: Logistic regression model was used to estimate odds ratio and corresponding 95% CI of treatment difference, with treatment as fixed effect and for post-baseline assessments baseline was included as a covariate.||2.110|0.972|0.0696
70862693|NCT03347188|141212159|SUPERIORITY||LS Mean|1.5|STANDARD_ERROR_OF_MEAN|1.11||0.1876|TWO_SIDED|95.0|-0.73|3.67||Threshold for significance at 0.05 level.|ANCOVA|||||3.67|-0.73|0.1876
70862694|NCT01193660|141212174|SUPERIORITY_OR_OTHER_LEGACY||Wilks' Lambda (group*visit effect)|2.59|||<|0.05||95.0|||||Repeated Measure ANOVA|||In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
70862695|NCT01193660|141212175|SUPERIORITY_OR_OTHER_LEGACY||Wilks' Lambda (group*visit effect)|3.94|||<|0.05||95.0|||||Repeated Measure ANOVA|||The null hypothesis is that in terms of K-BSID-II MENTAL Scale, the effects of 3 groups are same, and the alternative one is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
70862696|NCT01193660|141212176|SUPERIORITY_OR_OTHER_LEGACY||Wilks' Lambda (group*visit effect)|2.7|||<|0.05||95.0|||||Repeated Measure ANOVA|||The null hypothesis is that in terms of K-BSID-II MOTOR Scale, the effects of 3 groups are same, and the alternative one is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
70862697|NCT01193660|141212178|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0||||The baseline and post-therapy data of each group were compared using paired t-test statistics.|t-test, 2 sided|Voxels with an uncorrected p-value of \<0.05 were considered significant, and an extent threshold Ke of 100 voxels was set by SPM implanted in Matlab.||In our analysis, the null hypothesis is that the effects of three experimental groups are same each other, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) has much higher than that of either Erythropoietin + Rehabilitation Group or Rehabilitation Group. This study is a pilot study and therefore, power calculation was not applicable in our study. The sample size of each group is more than 30.||||0.05
70862698|NCT01193660|141212180|SUPERIORITY_OR_OTHER_LEGACY||interaction of group and visit|0.9|||<|0.05||95.0|||||Repeated Measure ANOVA|||In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
70862699|NCT01193660|141212181|SUPERIORITY_OR_OTHER_LEGACY||Wilks' Lambda (group*visit effect)|1.279|||<|0.05||95.0|||||Repeated Measure ANOVA|||In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
70862700|NCT01193660|141212182|SUPERIORITY_OR_OTHER_LEGACY||Wilks' Lambda (group*visit effect)|0.996|||<|0.05||95.0|||||Repeated Measure ANOVA|||In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
70947935|NCT01663506|141396759|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||TJC28: Change from Baseline at Month 12||||<0.01
71134987|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.92|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.92
70862701|NCT01193660|141212183|SUPERIORITY_OR_OTHER_LEGACY||Wilks' Lambda (group*visit effect)|0.56|||<|0.05||95.0|||||Repeated Measure ANOVA|||In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
71134988|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
71134989|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71134990|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.4|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.40
71134991|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.93|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.93
71134992|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.82|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.82
71134993|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71134994|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
71134995|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.69|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.69
71134996|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.53|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.53
71134997|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.59|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.59
71134998|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
71134999|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71135000|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
71135001|NCT01128426|141772116|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71135002|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.85|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.85
71135003|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
71135004|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method]|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
71135005|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.59|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.59
71135006|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
71135007|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71135008|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.53|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.53
71135009|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
70862702|NCT01193660|141212184|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Fisher Exact|We compared the ratio of participants with a certain adverse event (AE) and without the AE between three groups using Fisher Exact test.||||||<0.05
70862703|NCT00810108|141212193|NON_INFERIORITY_OR_EQUIVALENCE|The geometric mean and 90% confidence interval assessed whether the crushed and whole tablet administration AUCs were equivalent.|Ratio of Crushed/Whole Tablet AUC|0.55|||<|0.05|TWO_SIDED|90.0|0.45|0.69|||t-test, 2 sided|||Lopinavir AUC was compared between whole tablet and crushed tablet administration by using a ratio of crushed/whole AUC.||0.69|0.45|<0.05
70862704|NCT01051466|141212194|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||The significance level was 0.05 for a 2-sided test.|Mixed Models Analysis|||||||0.457
70862705|NCT01051466|141212195|SUPERIORITY_OR_OTHER|||||||0.627||||||The p-value is for change from baseline activation (BOLD response) in the anterior cingulate.|Mixed Models Analysis|||||||0.627
70862706|NCT01051466|141212195|SUPERIORITY_OR_OTHER|||||||0.338||||||The p-value is for change from baseline activation (BOLD response) in the left amygdala.|Mixed Models Analysis|||||||0.338
70862707|NCT01051466|141212195|SUPERIORITY_OR_OTHER|||||||0.518||||||The p-value is for change from baseline activation (BOLD response) in the right amygdala.|Mixed Models Analysis|||||||0.518
70862708|NCT01051466|141212196|SUPERIORITY_OR_OTHER|||||||0.03||||||The p-value is for change from baseline volume in the subgenual anterior cingulate.|Mixed Models Analysis|||||||0.030
70862709|NCT01051466|141212196|SUPERIORITY_OR_OTHER|||||||0.208||||||The p-value is for change from baseline volume in the left amygdalae.|Mixed Models Analysis|||||||0.208
70862710|NCT01051466|141212196|SUPERIORITY_OR_OTHER|||||||0.031||||||The p-value is for change from baseline volume in the right amygdalae.|Mixed Models Analysis|||||||0.031
70862711|NCT01051466|141212196|SUPERIORITY_OR_OTHER|||||||0.35||||||The p-value is for change from baseline volume in the left hippocampus.|Mixed Models Analysis|||||||0.350
70862712|NCT01051466|141212196|SUPERIORITY_OR_OTHER|||||||0.191||||||The p-value is for change from baseline volume in the right hippocampus.|Mixed Models Analysis|||||||0.191
70862713|NCT01051466|141212197|SUPERIORITY_OR_OTHER|||||||0.174||||||The p-value is for Gsα translocation in RBCs at Week 1.|Mixed Models Analysis|||||||0.174
70862714|NCT01051466|141212197|SUPERIORITY_OR_OTHER|||||||0.488||||||The p-value is for Gsα translocation in RBCs at Week 8.|Mixed Models Analysis|||||||0.488
70862715|NCT01051466|141212197|SUPERIORITY_OR_OTHER|||||||0.48||||||The p-value is for Gsα translocation in RBCs at Week 12.|Mixed Models Analysis|||||||0.480
70862716|NCT01051466|141212197|SUPERIORITY_OR_OTHER|||||||0.925||||||The p-value is for Gsα translocation in platelets at Week 1.|Mixed Models Analysis|||||||0.925
70862717|NCT01051466|141212197|SUPERIORITY_OR_OTHER|||||||0.697||||||The p-value is for Gsα translocation in platelets at Week 8.|Mixed Models Analysis|||||||0.697
70862718|NCT01051466|141212197|SUPERIORITY_OR_OTHER|||||||0.276||||||The p-value is for Gsα translocation in platelets at Week 12.|Mixed Models Analysis|||||||0.276
70862719|NCT01051466|141212199|SUPERIORITY_OR_OTHER|||||||0.904||||||The p-value is for change from baseline BDNF.|Mixed Models Analysis|||||||0.904
70862720|NCT01051466|141212199|SUPERIORITY_OR_OTHER|||||||0.819||||||The p-value is for change from baseline proBDNF.|Mixed Models Analysis|||||||0.819
70862721|NCT01051466|141212200|SUPERIORITY_OR_OTHER|||||||0.273||||||The p-value is for change from baseline trkB.|Mixed Models Analysis|||||||0.273
70862722|NCT01051466|141212201|SUPERIORITY_OR_OTHER|||||||0.797||||||The p-value is for change from baseline cytokine TNFα.|Mixed Models Analysis|||||||0.797
70862723|NCT01051466|141212201|SUPERIORITY_OR_OTHER|||||||0.269||||||The p-value is for change from baseline cytokine IL-1.|Mixed Models Analysis|||||||0.269
70862724|NCT01051466|141212201|SUPERIORITY_OR_OTHER|||||||0.925||||||The p-value is for change from baseline cytokine IL-6.|Mixed Models Analysis|||||||0.925
70862725|NCT01086423|141212220|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The upper limit (UL) of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|0.68|||||TWO_SIDED|95.0|-1.88|3.76||||||To demonstrate that the immunogenicity of Infanrix™ -IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-D, one month after the third vaccine dose.||3.76|-1.88|
70862726|NCT01086423|141212220|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.56|2.56||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-T, one month after the third vaccine dose.||2.56|-2.56|
70862727|NCT01086423|141212221|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|-7.93|||||TWO_SIDED|95.0|-14.44|-2.13||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-PRP antibodies, one month after the third vaccine dose.||-2.13|-14.44|
70862728|NCT01086423|141212222|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.51|2.56||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-Polio type 1 antibodies, one month after the third vaccine dose.||2.56|-2.51|
70872162|NCT01438957|141229572|SUPERIORITY|||||||0.897|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.897
70947936|NCT01663506|141396760|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.01
70872163|NCT01438957|141229573|SUPERIORITY|||||||0.897|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.897
70947937|NCT01663506|141396760|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.001
70947938|NCT01663506|141396761|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.01
70947939|NCT01663506|141396761|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.001
70947940|NCT01642147|141396768|SUPERIORITY_OR_OTHER|||||||0.554||95.0||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: Mean Blood Flow Velocity in Middle Cerebral Artery of the 2 groups are the same before anesthesia.~Power calculation: beta=0.2, alpha=0.05, two-tailed"||||0.554
70947941|NCT01642147|141396769|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: Mean Blood Flow Velocity in Middle Cerebral Artery of the 2 groups are the same at extubation.~Power calculation: beta=0.2, alpha=0.05, two-tailed"||||<0.001
70947942|NCT01642147|141396770|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: mean blood flow velocity in middle cerebral artery of the 2 groups are the same 30min after extubation.~Power calculation: beta=0.2, alpha=0.05, two-tailed"||||<0.001
70947943|NCT01642147|141396771|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: mean blood flow velocity in middle cerebral artery of the 2 groups are the same 60min after extubation.~Power calculation: beta=0.2, alpha=0.05, two-tailed"||||<0.001
71135010|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
71135011|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
71135012|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71135013|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
71135014|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71135015|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
71135016|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71135017|NCT01128426|141772116|SUPERIORITY_OR_OTHER|||||||0.94|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.94
71135018|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.56|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.56
71135019|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.43|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.43
71135020|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71135021|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
71135022|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71135023|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.93|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.93
71135024|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71135025|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.32|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.32
71135026|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
71135027|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
71135028|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
71135029|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.31|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.31
71135030|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.43|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.43
71135031|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
70862729|NCT01086423|141212222|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.51|2.56||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-Polio type 2 antibodies, one month after the third vaccine dose.||2.56|-2.51|
70862730|NCT01086423|141212222|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.51|2.56||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-Polio type 3 antibodies, one month after the third vaccine dose.||2.56|-2.51|
70862731|NCT01086423|141212223|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|-0.68|||||TWO_SIDED|95.0|-3.74|1.89||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-PT antigens, one month after the third vaccine dose.||1.89|-3.74|
70862732|NCT01086423|141212223|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|-2.7|||||TWO_SIDED|95.0|-6.75|-0.11||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-FHA antigens, one month after the third vaccine dose.||-0.11|-6.75|
70862733|NCT01086423|141212223|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|-0.67|||||TWO_SIDED|95.0|-4.6|3.04||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-PRN antigens, one month after the third vaccine dose.||3.04|-4.6|
70862734|NCT00749515|141212256|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<.001
70862735|NCT00749515|141212257|OTHER|||||||0.275|||||||t-test, 2 sided|||||||.275
70862736|NCT00749515|141212258|OTHER|||||||0.178|||||||t-test, 2 sided|||||||.178
70862737|NCT00749515|141212259|OTHER|||||||0.062|||||||t-test, 2 sided|||||||.062
70862738|NCT00749515|141212260|OTHER|||||||0.104|||||||t-test, 2 sided|||||||.104
71135032|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
70862739|NCT02617888|141212298|SUPERIORITY||Slope|0.08|||<|0.05|TWO_SIDED||||||Regression, Linear|||||||<0.05
70862740|NCT00277446|141212301|SUPERIORITY_OR_OTHER||||||<|0.03||95.0|||||t-test, 2 sided|||"The two groups tested were baseline and after 4 weeks of treatment with the soy isoflavone supplement."||||<0.03
70862741|NCT00277446|141212302|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|95.0|||||t-test, 2 sided|||"The two groups tested were baseline and after 4 weeks of treatment with the soy isoflavone supplement."||||0.02
70862742|NCT00277446|141212303|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||t-test, 2 sided|||"The two groups tested were baseline and after 4 weeks of treatment with the soy isoflavone supplement."||||0.88
70862743|NCT02448810|141212321|OTHER||Hazard Ratio (HR)|0.8||||0.246|TWO_SIDED|70.0|0.5|1.1||P-value is based on a one-sided log-rank test.|Log Rank||||Hazard Ratio and 70% CI are based on a Cox proportional hazards model with a covariate for treatment (imalumab vs SoC).|1.1|0.5|0.246
70862744|NCT02448810|141212321|OTHER||Hazard Ratio (HR)|0.8||||0.354|TWO_SIDED|70.0|0.5|1.4||P-value is based on a one-sided log-rank test.|Log Rank||||Hazard Ratio and 70% CI are based on a Cox proportional hazards model with a covariate for treatment (imalumab vs SoC).|1.4|0.5|0.354
71135033|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71135034|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.44|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.44
71135035|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
71135036|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.87|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.87
71135037|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
71135038|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
71135039|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
71135040|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
71135041|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.37|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.37
70862745|NCT02907268|141212333|EQUIVALENCE|"Each variable compared with the no change score. The no change score is 0 for wrinkles-related variables."|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70862746|NCT02907268|141212334|EQUIVALENCE|"Each variable compared with the no change score. The no change score is 0 for wrinkles-related variables."|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70862747|NCT02907268|141212335|EQUIVALENCE|"Each variable compared with the no change score. The no change score is 0 for wrinkles-related variables."|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70862748|NCT00457366|141212361|OTHER|We used an analysis of covariance (ANCOVA) with baseline as the covariate to analyze the PANSS-EC at hour 2.|||||>|0.05|||||||ANCOVA|||||||>0.05
70862749|NCT04856891|141212362|SUPERIORITY||Percent Difference from Placebo|78.4|||<|0.0001|TWO_SIDED|95.0|62.2|89.1|||Fisher Exact|||||89.1|62.2|<0.0001
70862750|NCT04856891|141212363|SUPERIORITY||LSM Difference from Placebo|0.3||||0.8822|TWO_SIDED|95.0|-4.0|4.7|||Mixed Models Analysis|||||4.7|-4.0|0.8822
70862751|NCT04856891|141212364|SUPERIORITY||LSM Difference from Placebo|-74.9|||<|0.0001|TWO_SIDED|95.0|-85.2|-64.7|||ANCOVA|||||-64.7|-85.2|<0.0001
70862752|NCT04856891|141212365|SUPERIORITY||Percent Difference from Placebo|80.4|||<|0.0001|TWO_SIDED|95.0|64.8|90.6|||Fisher Exact|||||90.6|64.8|<0.0001
70862753|NCT04856891|141212366|SUPERIORITY||Percent Difference from Placebo|43.5|||<|0.0001|TWO_SIDED|95.0|23.5|59.9|||Fisher Exact|||||59.9|23.5|<0.0001
70862754|NCT04856891|141212367|SUPERIORITY||Percent Difference from Placebo|-1.5||||1|TWO_SIDED|95.0|-22.2|18.0|||Fisher Exact|||||18.0|-22.2|1.0000
70862755|NCT04856891|141212368|SUPERIORITY||Percent Difference from Placebo|6.9||||0.4502|TWO_SIDED|95.0|-13.8|26.3|||Fisher Exact|||||26.3|-13.8|0.4502
70862756|NCT04856891|141212369|SUPERIORITY||LSM Difference from Placebo|-3.1||||0.6805|TWO_SIDED|95.0|-18.1|11.8|||Mixed Models Analysis|||Weeks 24 Percent Change from Baseline||11.8|-18.1|0.6805
70862757|NCT03438383|141212423|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.88||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h before surgery (pre-operative or baseline values)||||0.88
70862758|NCT03438383|141212423|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.23||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h post-operatively||||0.23
70862759|NCT03438383|141212423|SUPERIORITY|We checked for equivalence of the pre-op (baseline) values between the two groups. We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.008||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||48 hours post-operatively||||0.008
70862760|NCT03438383|141212423|SUPERIORITY|We checked for equivalence of the pre-op (baseline) values between the two groups. We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.001||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||72 h post-operatively||||0.001
70862761|NCT03438383|141212424|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) quantitative research sample size calculator (available online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.75||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h before surgery (pre-operative or baseline values)||||0.75
70862762|NCT03438383|141212424|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.09||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h post-operatively||||0.09
70862763|NCT03438383|141212424|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.008||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||48 h post-operatively||||0.008
70872164|NCT01438957|141229574|SUPERIORITY||||||<|0.001|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||<0.001
70872165|NCT01438957|141229574|SUPERIORITY|||||||0.002|||||||Mantel Haenszel|Stratified by the anesthesia type||||||0.002
70872166|NCT01438957|141229574|SUPERIORITY|||||||0.116|||||||Mantel Haenszel|Stratified by the anesthesia type||||||0.116
71135042|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.16|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.16
70872167|NCT01438957|141229575|SUPERIORITY|||||||0.088|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.088
71135043|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.85|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.85
71135044|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
71135045|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.18|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.18
71135046|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
71135047|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
71135048|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.66|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.66
70862764|NCT03438383|141212424|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.013||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||72 h post-operatively||||0.013
70862765|NCT03438383|141212425|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) quantitative research sample size calculator (available online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.05||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h before surgery (pre-operative or baseline values)||||0.05
70862766|NCT03438383|141212425|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.55||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h post-operatively||||0.55
70862767|NCT03438383|141212425|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.13||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||48h post-operatively||||0.13
70862768|NCT03438383|141212425|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.011||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||72 h post-operatively||||0.011
70862769|NCT03438383|141212426|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) quantitative research sample size calculator (available online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.83||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h before surgery (pre-operative or baseline values)||||0.83
70862770|NCT03438383|141212426|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.37||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h post-operatively||||0.37
70862771|NCT03438383|141212426|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.0035||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||48 h post-operatively||||0.0035
70872168|NCT01438957|141229576|SUPERIORITY|||||||0.085|||||||Log Rank|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.085
70947944|NCT01642147|141396772|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: mean blood flow velocity in middle cerebral artery of the 2 groups are the same 90min after extubation.~Power calculation: beta=0.2, alpha=0.05, two-tailed"||||<0.001
70947945|NCT01642147|141396773|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: mean blood flow velocity in middle cerebral artery of the 2 groups are the same 120min after extubation.~Power calculation: beta=0.2, alpha=0.05, two-tailed"||||<0.001
70947946|NCT02229578|141396820|SUPERIORITY||Mean Difference (Final Values)|0.45|||<|0.05|TWO_SIDED|95.0|-1.2|2.1|||t-test, 2 sided|||Outcome was residual change score calculated by regressing immediate postop pain on 24 hour pain. This allows patient to serve as own control for intial values.||2.1|-1.2|<0.05
71135049|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.31|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.31
70947947|NCT02229578|141396821|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.79|<|0.05|TWO_SIDED|95.0|-1.77|1.49|||t-test, 2 sided|||Outcome was residual change score calculated by regressing immediate postop pain on 24 hour pain. This allows patient to serve as own control for intial values.||1.49|-1.77|<0.05
70947948|NCT02229578|141396822|SUPERIORITY||Mean Difference (Final Values)|-1.76|STANDARD_ERROR_OF_MEAN|3.61|<|0.05|TWO_SIDED|95.0|-9.62|6.09|||t-test, 2 sided|||Outcome was residual change score calculated by regressing immediate postop hydromorphone on 24 hour hydromorphone. This allows patient to serve as own control for intial values.||6.09|-9.62|<0.05
70947949|NCT01407276|141396842|SUPERIORITY_OR_OTHER||GMR|0.94|||||TWO_SIDED|90.0|0.8|1.11|||Geometric mean ratio (GMR)|GMR of Panel A:Panel B||||1.11|0.80|
70947950|NCT01407276|141396842|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|1.34|||||TWO_SIDED|90.0|1.12|1.61|||GMR of Panel C:Panel D|||||1.61|1.12|
71135050|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.22|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.22
70862772|NCT03438383|141212426|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||1.5e-05||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||72 h post-operatively||||0.000015
70862773|NCT02766465|141212432|SUPERIORITY||||||<|0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing severe vaso-occlusive pain (VOC) with hospitalization or parenteral opioid drugs in outpatient setting between two biologically assigned arms during the first year after biologic assignment. The null hypothesis is that there is no difference in biologically assigned arms during the first year after assignment.||||<0.001
70862774|NCT02766465|141212432|SUPERIORITY|||||||0.027||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing significant cerebrovascular event between two biologically assigned arms during the first year after biologic assignment. Significant cerebrovascular event includes stroke, transient ischemic attack, and seizure. The null hypothesis is that there is no difference in biologically assigned arms during the first year after assignment.||||0.027
70862775|NCT02766465|141212432|SUPERIORITY||||||<|0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing severe Vaso-occlusive pain (VOC) with hospitalization or parenteral opioid drugs in outpatient setting between two biologically assigned arms during the second year after biologic assignment. The null hypothesis is that there is no difference in biologically assigned arms during the second year after assignment.||||< 0.001
70862776|NCT02766465|141212433|SUPERIORITY|||||||0.869||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing 6MWD from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.869
70862777|NCT02766465|141212434|SUPERIORITY|||||||0.636||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing TRJV from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.636
70862778|NCT02766465|141212436|SUPERIORITY|||||||0.242||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing Physical Function changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.242
70862779|NCT02766465|141212437|SUPERIORITY|||||||0.343||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing Anxiety changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.343
70862780|NCT02766465|141212438|SUPERIORITY|||||||0.491||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing Depression changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.491
70862781|NCT02766465|141212439|SUPERIORITY|||||||0.003||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing fatigue score changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.003
70862782|NCT02766465|141212440|SUPERIORITY|||||||0.594||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing Sleep Disturbance changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.594
70862783|NCT02766465|141212441|SUPERIORITY|||||||0.003||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing social roles score changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.003
70862784|NCT02766465|141212442|SUPERIORITY|||||||0.071||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing pain interference score changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.071
71135051|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
70862785|NCT02766465|141212443|SUPERIORITY|||||||0.146||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing Pain Intensity changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.146
70862786|NCT02766465|141212444|SUPERIORITY|||||||0.649||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing 28-Day Pain Diary Average Pain Intensity changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.649
70947951|NCT01407276|141396842|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|1.56|||||TWO_SIDED|90.0|1.32|1.85|||GMR of Panel E:Panel F|||||1.85|1.32|
71135052|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
71135053|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
71135054|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
70862787|NCT02766465|141212445|SUPERIORITY|||||||0.207||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing ASCQ-Me Stiffness changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.207
70862788|NCT02766465|141212446|SUPERIORITY|||||||0.596||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing FEV1 changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.596
70862789|NCT02766465|141212447|SUPERIORITY|||||||0.684||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing FVC changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.684
70862790|NCT02766465|141212448|SUPERIORITY|||||||0.863||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing FEV1/FVC changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.863
70862791|NCT02766465|141212449|SUPERIORITY|||||||0.455||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing VC changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.455
70947952|NCT01407276|141396842|SUPERIORITY_OR_OTHER||GMR or Panel G:Panel H|1.89|||||TWO_SIDED|90.0|1.4|2.55|||GMR of Panel G:Panel H|||||2.55|1.40|
71135055|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
70862792|NCT02766465|141212450|SUPERIORITY|||||||0.767||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing TLC changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.767
70947953|NCT01407276|141396842|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|1.97|||||TWO_SIDED|90.0|1.46|2.66|||GMR of Panel G:Panel H|||||2.66|1.46|
70947954|NCT01407276|141396843|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|0.94|||||TWO_SIDED|90.0|0.79|1.12|||GMR of Panel A:Panel B|||||1.12|0.79|
70947955|NCT01407276|141396843|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|1.13|||||TWO_SIDED|90.0|0.91|1.41|||GMR of Panel C:Panel D|||||1.41|0.91|
70947956|NCT01407276|141396843|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.9|||||TWO_SIDED|90.0|0.66|1.23|||GMR of Panel E:Panel F|||||1.23|0.66|
70947957|NCT01407276|141396843|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.74|||||TWO_SIDED|90.0|0.57|0.96|||GMR of Panel E:Panel F|||||0.96|0.57|
71135056|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.74|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.74
71135057|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.69|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.69
71135058|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
71135059|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.72|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.72
71135060|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
71135061|NCT01128426|141772117|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71135062|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
71135063|NCT01128426|141772117|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
71135064|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
71135065|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
71135066|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71135067|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
71135068|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.18|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.18
71135069|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.93|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.93
71135070|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
71135071|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71135072|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.17|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.17
71135073|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
71135074|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
71135075|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
71135076|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.46|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.46
71135077|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.42|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.42
71135078|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.49|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.49
71135079|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.69|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.69
71135080|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
71135081|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.69|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.69
71135082|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
71135083|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
71135084|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.57|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.57
70947958|NCT01407276|141396843|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.73|||||TWO_SIDED|90.0|0.56|0.95|||GMR of Panel E:Panel F|||||0.95|0.56|
71135085|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.18|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.18
70947959|NCT01407276|141396844|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|0.92|||||TWO_SIDED|90.0|0.81|1.05|||GMR of Panel A:Panel B|||||1.05|0.81|
70947960|NCT01407276|141396844|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|1.33||||||90.0|1.07|1.65|||GMR of Panel C:Panel D|||||1.65|1.07|
70947961|NCT01407276|141396844|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|1.37|||||TWO_SIDED|90.0|1.13|1.65|||GMR of Panel E:Panel F|||||1.65|1.13|
71135086|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
71135087|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.45|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.45
71135088|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
71135089|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.66|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.66
71135090|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
71135091|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
71135092|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.69|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.69
71135093|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.53|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.53
70862793|NCT02766465|141212451|SUPERIORITY|||||||0.241||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing RV changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.241
70862794|NCT02766465|141212452|SUPERIORITY|||||||0.268||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing ERV changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.268
70862795|NCT02766465|141212453|SUPERIORITY||||||>|0.999||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing IC changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||>0.999
70862796|NCT02766465|141212454|SUPERIORITY|||||||0.832||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing FRC changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.832
70862797|NCT02766465|141212455|SUPERIORITY|||||||0.37||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing DLCO changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.370
70862798|NCT02766465|141212456|SUPERIORITY|||||||0.094||||||Statistical significance was determined using a pre-specified threshold of 0.05;|Wilcoxon (Mann-Whitney)|||This is the result comparing oxygen saturation changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.094
70862799|NCT02766465|141212458|SUPERIORITY|||||||0.313||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of grade II-IV acute GVHD in patients who received different donor type at transplant||||0.313
70862800|NCT02766465|141212459|SUPERIORITY|||||||0.233||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of chronic GVHD in patients who received different donor type at transplant||||0.233
70862801|NCT02435069|141212462|SUPERIORITY|||||||0.069751||||||significance level set at \<0.05 a priori|two-sample pooled variance t-test|Two-tailed||"Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. and calculated on the data from the last day of the completed NS and USP Glycerin phases of the study.~Power analysis conducted using data from this study with α = 0.5, power of .80, correlation between two means of .598, and effect size of 1.554 estimated a sample size of 11 would be needed to minimize the risk of a Type II error to (20%)."||||0.069751
70862802|NCT02435069|141212463|SUPERIORITY|||||||0.172|||||||two-sample pooled variance t-test|two tailed||Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. and calculated on the data from the last day of the completed NS and USP Glycerin phases of the study.||||0.172
70862803|NCT02435069|141212466|SUPERIORITY|||||||0.8028|||||||two-sample pooled variance t-test|two-sided||Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. and calculated on the data from the difference in calprotectin levels between samples obtained at baseline and samples obtained following the completion of the NS and USP Glycerin flush in the dosing phase of the study.||||0.8028
70862804|NCT02435069|141212467|SUPERIORITY|||||||0.346594|||||||two-sample pooled variance t test|two tailed||Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. and calculated on the data from the last day of the completed NS and USP Glycerin phases of the study.||||0.346594
70862805|NCT02520661|141212472|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.62|1.22||||||treatment relevant change in number of ED visits by 14 days||1.22|0.62|
70862806|NCT02520661|141212472|SUPERIORITY||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.72|1.3||||||treatment relevant change in number of ED visits by 30 days||1.30|0.72|
70862807|NCT01532973|141212491|SUPERIORITY_OR_OTHER||Difference in LS Means|4.26|||||TWO_SIDED|90.0|3.77|4.74||||||||4.74|3.77|
70862808|NCT01532973|141212491|SUPERIORITY_OR_OTHER||Difference in LS Means|4.41|||||TWO_SIDED|90.0|3.92|4.9||||||||4.90|3.92|
70862809|NCT01532973|141212491|SUPERIORITY_OR_OTHER||Difference in LS Means|3.56|||||TWO_SIDED|90.0|3.08|4.05||||||||4.05|3.08|
70862810|NCT01532973|141212492|SUPERIORITY_OR_OTHER||Difference in LS Means|1.02|||||TWO_SIDED|90.0|0.34|1.69||||||||1.69|0.34|
70862811|NCT01532973|141212492|SUPERIORITY_OR_OTHER||Difference in LS Means|2.07|||||TWO_SIDED|90.0|1.39|2.74||||||||2.74|1.39|
70862812|NCT01532973|141212492|SUPERIORITY_OR_OTHER||Difference in LS Means|2.72|||||TWO_SIDED|90.0|2.05|3.39||||||||3.39|2.05|
70862813|NCT01532973|141212493|SUPERIORITY_OR_OTHER||Difference in LS Means|3.2|||||TWO_SIDED|90.0|2.68|3.72||||||||3.72|2.68|
70862814|NCT01532973|141212493|SUPERIORITY_OR_OTHER||Difference in LS Means|3.95|||||TWO_SIDED|90.0|3.44|4.47||||||||4.47|3.44|
70862815|NCT01532973|141212494|SUPERIORITY_OR_OTHER||Difference in LS Means|3.89|||||TWO_SIDED|90.0|3.2|4.58||||||||4.58|3.20|
70862816|NCT01532973|141212494|SUPERIORITY_OR_OTHER||Difference in LS Means|4.67|||||TWO_SIDED|90.0|3.98|5.36||||||||5.36|3.98|
70862817|NCT01532973|141212494|SUPERIORITY_OR_OTHER||Difference in LS Means|3.61|||||TWO_SIDED|90.0|2.92|4.3||||||||4.30|2.92|
70862818|NCT01532973|141212495|SUPERIORITY_OR_OTHER||Difference in LS Means|0.72|||||TWO_SIDED|90.0|-0.09|1.54||||||||1.54|-0.09|
70862819|NCT01532973|141212495|SUPERIORITY_OR_OTHER||Difference in LS Means|2.57|||||TWO_SIDED|90.0|1.75|3.39||||||||3.39|1.75|
70862820|NCT01532973|141212495|SUPERIORITY_OR_OTHER||Difference in LS Means|2.84|||||TWO_SIDED|90.0|2.02|3.66||||||||3.66|2.02|
70862821|NCT01532973|141212496|SUPERIORITY_OR_OTHER||Difference in LS Means|3.17|||||TWO_SIDED|90.0|2.55|3.8||||||||3.80|2.55|
70862822|NCT01532973|141212496|SUPERIORITY_OR_OTHER||Difference in LS Means|3.63|||||TWO_SIDED|90.0|3.0|4.26||||||||4.26|3.00|
70947962|NCT01407276|141396844|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|1.38|||||TWO_SIDED|90.0|1.06|1.79|||GMR of Panel G:Panel H|||||1.79|1.06|
70862823|NCT01920555|141212619|SUPERIORITY||Mean Difference (Final Values)|-3.18||||0.14|TWO_SIDED|95.0|-5.93|-0.43||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.43|-5.93|0.14
70862824|NCT01920555|141212619|SUPERIORITY||Mean Difference (Final Values)|-1.13||||0.79|TWO_SIDED|95.0|-3.75|1.49||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||1.49|-3.75|0.79
70947963|NCT01407276|141396844|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|1.3|||||TWO_SIDED|90.0|1.0|1.68|||GMR of Panel G:Panel H|||||1.68|1.00|
70947964|NCT01407276|141396845|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|0.92|||||TWO_SIDED|90.0|0.75|1.12|||GMR of Panel A:Panel B|||||1.12|0.75|
71135094|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.16|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.16
70947965|NCT01407276|141396845|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|1.45|||||TWO_SIDED|90.0|1.19|1.76|||GMR of Panel C:Panel D|||||1.76|1.19|
70947966|NCT01407276|141396845|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|1.83|||||TWO_SIDED|90.0|1.49|2.24|||GMR of Panel E:Panel F|||||2.24|1.49|
70947967|NCT01407276|141396845|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|1.9|||||TWO_SIDED|90.0|1.41|2.54|||GMR of Panel G:Panel H|||||2.54|1.41|
71135095|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
71135096|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
71135097|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
71135098|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
71135099|NCT01128426|141772118|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71135100|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.22|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.22
71135101|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
71135102|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.17|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.17
71135103|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.87|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.87
71135104|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
71135105|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.54|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.54
71135106|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
71135107|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
71135108|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
71135109|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
71135110|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
71135111|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.29|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.29
71135112|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
71135113|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.61|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.61
71135114|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
70947968|NCT01407276|141396845|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|1.88|||||TWO_SIDED|90.0|1.4|2.52|||GMR of Panel G:Panel H|||||2.52|1.40|
71135115|NCT01128426|141772118|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
70947969|NCT01407276|141396846|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|1.11|||||TWO_SIDED|90.0|0.87|1.42|||GMR of Panel A:Panel B|||||1.42|0.87|
70947970|NCT01407276|141396846|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|0.75|||||TWO_SIDED|90.0|0.53|1.07|||GMR of Panel C:Panel D|||||1.07|0.53|
70947971|NCT01407276|141396846|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.68|||||TWO_SIDED|90.0|0.51|0.92|||GMR of Panel E:Panel F|||||0.92|0.51|
70947972|NCT01407276|141396846|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|0.7|||||TWO_SIDED|90.0|0.5|0.98|||GMR of Panel G:Panel H|||||0.98|0.50|
71135116|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
71135117|NCT01128426|141772118|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
71135118|NCT00550953|141772119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.02|STANDARD_ERROR_OF_MEAN|0.82|<|0.0001|TWO_SIDED|95.0|6.41|9.63|||ANCOVA||Difference calculated as telmisartan 40 mg plus amlodipine 5 mg fixed-dose combination minus telmisartan 40 mg monotherapy|||9.63|6.41|<0.0001
71135119|NCT02905266|141772131|SUPERIORITY||Percent Difference in incidence rates|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Fixed Ratio Combination over Sequential Combination|||0.0|0.0|
71135120|NCT02905266|141772139|SUPERIORITY||Percent Difference of ORRs|-7.5|||||TWO_SIDED|95.0|-26.1|11.0|||||Cochran-Mantel-Haenszel (CMH) method of weighting|||11.0|-26.1|
71135121|NCT02905266|141772139|SUPERIORITY||Odds Ratio (OR)|0.75|||||TWO_SIDED|95.0|0.35|1.58||||||||1.58|0.35|
71135122|NCT02905266|141772140|SUPERIORITY||Hazard Ratio (HR)|1.36|||||TWO_SIDED|95.0|0.78|2.37|||||Stratified Cox proportional hazard model|||2.37|0.78|
71135123|NCT02905266|141772141|SUPERIORITY||Cochran-Mantel-Haenszel Odds Ratio|0.87|||||TWO_SIDED|95.0|0.3|2.49|||||Fixed Ratio Combination over Sequential Combination|||2.49|0.30|
71135124|NCT02905266|141772141|SUPERIORITY||Percent difference in incidence rates|-1.9|||||TWO_SIDED|95.0|-16.0|12.2|||||Fixed Ratio Combination over Sequential Combination|||12.2|-16.0|
71135125|NCT02777827|141772148|SUPERIORITY||Least square mean|0.2221|STANDARD_ERROR_OF_MEAN|0.0453|<|0.0001|TWO_SIDED|95.0|0.1324|0.3118|||ANCOVA|||||0.3118|0.1324|<0.0001
71135126|NCT02777827|141772148|SUPERIORITY||Least Square Mean|0.4042|STANDARD_ERROR_OF_MEAN|0.0453|<|0.0001|TWO_SIDED|95.0|0.3146|0.4938|||ANCOVA|||||0.4938|0.3146|<0.0001
71135127|NCT02777827|141772148|SUPERIORITY||Least Square Mean|0.1056|STANDARD_ERROR_OF_MEAN|0.0451||0.0207|TWO_SIDED|95.0|0.0164|0.1949|||ANCOVA|||||0.1949|0.0164|0.0207
71135128|NCT02777827|141772148|SUPERIORITY||Least Square Mean|0.1701|STANDARD_ERROR_OF_MEAN|0.045||0.0002|TWO_SIDED|95.0|0.081|0.2592|||ANCOVA|||||0.2592|0.0810|0.0002
71135129|NCT02777827|141772148|SUPERIORITY||Least Square Mean|0.4062|STANDARD_ERROR_OF_MEAN|0.0451|<|0.0001|TWO_SIDED|95.0|0.317|0.4955|||ANCOVA|||||0.4955|0.3170|<0.0001
71135130|NCT03160898|141772172|SUPERIORITY||least squares mean treatment difference|1.61|STANDARD_ERROR_OF_MEAN|1.003||0.1095|TWO_SIDED|95.0|-0.36|3.58|||Mixed Models Analysis|Analyzed by an MMRM with contrast (-5, -1, 3, 3) to reflect the assumed relationship for the 4 groups: placebo, 150, 300, and 450 mg twice daily.||"The statistical null hypothesis was as follows: there was no assumed dose-response relationship in percent predicted SVC change from baseline to Week 12 among all three active doses and placebo, expressed as:~H0: -5 x µ placebo - 1 x µ 150 mg twice daily + 3 x µ 300 mg twice daily + 3 x µ 450 mg twice daily = 0 where µ was the mean of the efficacy endpoint for the designated group."||3.58|-0.36|0.1095
71135131|NCT03160898|141772172|SUPERIORITY||Least squares mean difference|1.49|STANDARD_ERROR_OF_MEAN|1.291||0.2501|TWO_SIDED|95.0|-1.05|4.03|||Mixed Models Analysis|||||4.03|-1.05|0.2501
71135132|NCT03160898|141772172|SUPERIORITY||Least squares mean difference|1.84|STANDARD_ERROR_OF_MEAN|1.29||0.1549|TWO_SIDED|95.0|-0.7|4.38|||Mixed Models Analysis|||||4.38|-0.7|0.1549
71135133|NCT03160898|141772172|SUPERIORITY||Least squares mean difference|1.88|STANDARD_ERROR_OF_MEAN|1.274||0.1417|TWO_SIDED|95.0|-0.63|4.38|||Mixed Models Analysis|||||4.38|-0.63|0.1417
71135134|NCT03160898|141772172|SUPERIORITY||Least squares mean difference|1.86|STANDARD_ERROR_OF_MEAN|1.115||0.0964|TWO_SIDED|95.0|-0.33|4.05|||Mixed Models Analysis|||||4.05|-0.33|0.0964
71135135|NCT03160898|141772173|SUPERIORITY||Least squares mean difference|0.56|STANDARD_ERROR_OF_MEAN|0.335||0.093|TWO_SIDED|95.0|-0.09|1.22|||Mixed Models Analysis|Analyzed by an MMRM with contrast (-5, -1, 3, 3) to reflect the assumed relationship for the 4 groups: placebo, 150, 300, and 450 mg twice daily.||||1.22|-0.09|0.0930
71135136|NCT03160898|141772173|SUPERIORITY||Least squares mean difference|1.13|STANDARD_ERROR_OF_MEAN|0.427||0.0087|TWO_SIDED|95.0|0.29|1.97|||Mixed Models Analysis|||||1.97|0.29|0.0087
71135137|NCT03160898|141772173|SUPERIORITY||Least squares mean difference|0.91|STANDARD_ERROR_OF_MEAN|0.43||0.0351|TWO_SIDED|95.0|0.06|1.75|||Mixed Models Analysis|||||1.75|0.06|0.0351
71135138|NCT03160898|141772173|SUPERIORITY||Least squares mean difference|0.59|STANDARD_ERROR_OF_MEAN|0.425||0.1642|TWO_SIDED|95.0|-0.24|1.43|||Mixed Models Analysis|||||1.43|-0.24|0.1642
71135139|NCT03160898|141772173|SUPERIORITY||Least squares mean difference|0.75|STANDARD_ERROR_OF_MEAN|0.371||0.0435|TWO_SIDED|95.0|0.02|1.48|||Mixed Models Analysis|||||1.48|0.02|0.0435
71135140|NCT03160898|141772174|SUPERIORITY||Slope difference|0.0276|STANDARD_ERROR_OF_MEAN|0.02734||0.3134|TWO_SIDED|95.0|-0.0261|0.0813|||Mixed Models Analysis|Analyzed by an MMRM with contrast (-5, -1, 3, 3) to reflect the assumed relationship for the 4 groups: placebo, 150, 300, and 450 mg twice daily.||||0.0813|-0.0261|0.3134
71135141|NCT03160898|141772174|SUPERIORITY||Least squares mean difference|0.0246||||0.4824|TWO_SIDED|95.0|-0.0442|0.0935|||Mixed Models Analysis|||||0.0935|-0.0442|0.4824
71135142|NCT03160898|141772174|SUPERIORITY||Least squares mean difference|0.0146||||0.6787|TWO_SIDED|95.0|-0.0544|0.0835|||Mixed Models Analysis|||||0.0835|-0.0544|0.6787
70947973|NCT01407276|141396846|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|0.8|||||TWO_SIDED|90.0|0.57|1.12|||GMR of Panel G:Panel H|||||1.12|0.57|
71135143|NCT03160898|141772174|SUPERIORITY||Least squares mean difference|0.0488||||0.1604|TWO_SIDED|95.0|-0.0194|0.1171|||Mixed Models Analysis|||||0.1171|-0.0194|0.1604
71135144|NCT03160898|141772174|SUPERIORITY||Least squares mean difference|0.0317||||0.2966|TWO_SIDED|95.0|-0.0279|0.0913|||Mixed Models Analysis|||||0.0913|-0.0279|0.2966
71135145|NCT04177212|141772191|OTHER||||||<|0.0001||||||P-value for testing null-hypothesis that response of Pooled Group was less or equal to 50 percent (%).|One-sided binomial test|||Between Groups calculation were not done because comparing Groups A and B was not part of the objective of this investigation.||||< 0.0001
71135146|NCT04177212|141772192|OTHER|||||||0.0003||||||P-value for testing null-hypothesis that response of Pooled Group was less or equal to 50%.|One-sided binomial test|||Between Groups calculation were not done because comparing Groups A and B was not part of the objective of this investigation.||||0.0003
71135147|NCT00857857|141772205|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.1033|||TWO_SIDED|95.0|0.031|0.449||||||||0.449|0.031|
71135148|NCT00857857|141772205|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.265|STANDARD_ERROR_OF_MEAN|0.1048|||TWO_SIDED|95.0|0.053|0.477||||||||0.477|0.053|
71135149|NCT00857857|141772205|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.456|STANDARD_ERROR_OF_MEAN|0.0993|||TWO_SIDED|95.0|0.255|0.657||||||||0.657|0.255|
71135150|NCT00857857|141772205|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.526|STANDARD_ERROR_OF_MEAN|0.1025|||TWO_SIDED|95.0|0.319|0.733||||||||0.733|0.319|
71135151|NCT00857857|141772206|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.0975|||TWO_SIDED|95.0|0.013|0.407||||||||0.407|0.013|
71135152|NCT00857857|141772206|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.154|STANDARD_ERROR_OF_MEAN|0.0988|||TWO_SIDED|95.0|-0.046|0.354||||||||0.354|-0.046|
71135153|NCT00857857|141772206|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.303|STANDARD_ERROR_OF_MEAN|0.0937|||TWO_SIDED|95.0|0.113|0.492||||||||0.492|0.113|
71135154|NCT00857857|141772206|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.404|STANDARD_ERROR_OF_MEAN|0.0966|||TWO_SIDED|95.0|0.209|0.599||||||||0.599|0.209|
71135155|NCT00857857|141772207|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.025|STANDARD_ERROR_OF_MEAN|0.1372|||TWO_SIDED|95.0|-0.302|0.253|||||Comparison of Minimum FEV1 between Placebo and GW870086 0.25 mg.|||0.253|-0.302|
70862825|NCT01920555|141212619|SUPERIORITY||Mean Difference (Final Values)|-4.79|||<|0.01|TWO_SIDED|95.0|-7.35|-2.24||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-2.24|-7.35|<0.01
70872169|NCT01438957|141229577|SUPERIORITY|||||||0.005|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.005
71135156|NCT00857857|141772207|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.106|STANDARD_ERROR_OF_MEAN|0.1391|||TWO_SIDED|95.0|-0.176|0.387|||||Comparison of Minimum FEV1 between Placebo and GW870086 1 mg.|||0.387|-0.176|
71135157|NCT00857857|141772207|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.239|STANDARD_ERROR_OF_MEAN|0.1319|||TWO_SIDED|95.0|-0.028|0.506|||||Comparison of Minimum FEV1 between Placebo and GW870086 3 mg.|||0.506|-0.028|
71135158|NCT00857857|141772207|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.534|STANDARD_ERROR_OF_MEAN|0.1359|||TWO_SIDED|95.0|0.26|0.809|||||Comparison of Minimum FEV1 between Placebo and fluticasone propionate 0.25 mg BID.|||0.809|0.260|
71135159|NCT00857857|141772207|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.054|STANDARD_ERROR_OF_MEAN|0.0984|||TWO_SIDED|95.0|-0.145|0.253|||||Comparison of Weighted Mean FEV1 between Placebo and GW870086 0.25 mg.|||0.253|-0.145|
71135160|NCT00857857|141772207|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.026|STANDARD_ERROR_OF_MEAN|0.0998|||TWO_SIDED|95.0|-0.176|0.228|||||Comparison of Weighted Mean FEV1 between Placebo and GW870086 1 mg.|||0.228|-0.176|
71135161|NCT00857857|141772207|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.0945|||TWO_SIDED|95.0|-0.011|0.371|||||Comparison of Weighted Mean FEV1 between Placebo and GW870086 3 mg.|||0.371|-0.011|
71135162|NCT00857857|141772207|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.0978|||TWO_SIDED|95.0|0.153|0.548|||||Comparison of Weighted Mean FEV1 between Placebo and fluticasone propionate 0.25 mg BID.|||0.548|0.153|
71135163|NCT00857857|141772208|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.71|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|0.56|0.9||||||||0.90|0.56|
71135164|NCT00857857|141772208|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.66|STANDARD_ERROR_OF_MEAN|0.107|||TWO_SIDED|95.0|0.53|0.82||||||||0.82|0.53|
71135165|NCT00857857|141772208|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.59|STANDARD_ERROR_OF_MEAN|0.112|||TWO_SIDED|95.0|0.47|0.74||||||||0.74|0.47|
71135166|NCT00857857|141772208|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.45|STANDARD_ERROR_OF_MEAN|0.107|||TWO_SIDED|95.0|0.36|0.55||||||||0.55|0.36|
71135167|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.021|STANDARD_ERROR_OF_MEAN|0.1086|||TWO_SIDED|95.0|-0.199|0.24|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 5 minutes|||0.240|-0.199|
71135168|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.164|STANDARD_ERROR_OF_MEAN|0.1285|||TWO_SIDED|95.0|-0.096|0.424|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 10 minutes|||0.424|-0.096|
71135169|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.024|STANDARD_ERROR_OF_MEAN|0.1526|||TWO_SIDED|95.0|-0.285|0.333|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 15 minutes|||0.333|-0.285|
71135170|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.069|STANDARD_ERROR_OF_MEAN|0.1471|||TWO_SIDED|95.0|-0.229|0.366|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 20 minutes|||0.366|-0.229|
71135171|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.011|STANDARD_ERROR_OF_MEAN|0.1313|||TWO_SIDED|95.0|-0.277|0.254|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 30 minutes|||0.254|-0.277|
71135172|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.016|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|95.0|-0.269|0.302|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 45 minutes|||0.302|-0.269|
71135173|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.046|STANDARD_ERROR_OF_MEAN|0.1265|||TWO_SIDED|95.0|-0.21|0.301|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 1 hour|||0.301|-0.210|
71135174|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.045|STANDARD_ERROR_OF_MEAN|0.1102|||TWO_SIDED|95.0|-0.178|0.268|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 1.5 hours|||0.268|-0.178|
71135175|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.096|STANDARD_ERROR_OF_MEAN|0.0985|||TWO_SIDED|95.0|-0.103|0.295|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 2 hours|||0.295|-0.103|
71135176|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.045|STANDARD_ERROR_OF_MEAN|0.0826|||TWO_SIDED|95.0|-0.121|0.212|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 2.5 hours|||0.212|-0.121|
71135177|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.027|STANDARD_ERROR_OF_MEAN|0.0832|||TWO_SIDED|95.0|-0.141|0.196|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 3 hours|||0.196|-0.141|
71135178|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.042|STANDARD_ERROR_OF_MEAN|0.0888|||TWO_SIDED|95.0|-0.138|0.221|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 3.5 hours|||0.221|-0.138|
71135179|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.027|STANDARD_ERROR_OF_MEAN|0.0934|||TWO_SIDED|95.0|-0.215|0.162|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 4 hour|||0.162|-0.215|
71135180|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.139|STANDARD_ERROR_OF_MEAN|0.1065|||TWO_SIDED|95.0|-0.076|0.354|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 4.5 hours|||0.354|-0.076|
71135181|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.149|STANDARD_ERROR_OF_MEAN|0.0955|||TWO_SIDED|95.0|-0.044|0.342|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 5 hours|||0.342|-0.044|
71135182|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.084|STANDARD_ERROR_OF_MEAN|0.1005|||TWO_SIDED|95.0|-0.119|0.288|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 5.5 hours|||0.288|-0.119|
71135183|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.212|STANDARD_ERROR_OF_MEAN|0.1122|||TWO_SIDED|95.0|-0.015|0.438|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 6 hours|||0.438|-0.015|
70862826|NCT01920555|141212619|SUPERIORITY||Mean Difference (Final Values)|-3.76||||0.04|TWO_SIDED|95.0|-6.37|-1.15|||Mixed Models Analysis|||"Ketamine 1.0mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-1.15|-6.37|0.04
70872170|NCT01438957|141229577|SUPERIORITY|||||||0.014|||||||Mantel Haenszel|Stratified by the anesthesia type||||||0.014
70872171|NCT01438957|141229577|SUPERIORITY|||||||0.055|||||||Mantel Haenszel|Stratified by the anesthesia type||||||0.055
70947974|NCT01407276|141396847|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|1.06|||||TWO_SIDED|90.0|0.9|1.25|||GMR of Panel A:Panel B|||||1.25|0.90|
71135184|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.162|STANDARD_ERROR_OF_MEAN|0.1051|||TWO_SIDED|95.0|-0.051|0.374|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 6.5 hours|||0.374|-0.051|
71135185|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.222|STANDARD_ERROR_OF_MEAN|0.1181|||TWO_SIDED|95.0|-0.017|0.461|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 7 hour|||0.461|-0.017|
71135186|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.185|STANDARD_ERROR_OF_MEAN|0.1355|||TWO_SIDED|95.0|-0.089|0.458|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 7.5 hours|||0.458|-0.089|
71135187|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.247|STANDARD_ERROR_OF_MEAN|0.1187|||TWO_SIDED|95.0|0.007|0.487|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 8 hours|||0.487|0.007|
71135188|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.244|STANDARD_ERROR_OF_MEAN|0.1313|||TWO_SIDED|95.0|-0.021|0.509|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 8.5 hours|||0.509|-0.021|
71135189|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.154|STANDARD_ERROR_OF_MEAN|0.1189|||TWO_SIDED|95.0|-0.086|0.394|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 9 hours|||0.394|-0.086|
71135190|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.175|STANDARD_ERROR_OF_MEAN|0.1085|||TWO_SIDED|95.0|-0.044|0.394|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 9.5 hours|||0.394|-0.044|
70947975|NCT01407276|141396847|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|0.75|||||TWO_SIDED|90.0|0.62|0.89|||GMR of Panel C:Panel D|||||0.89|0.62|
71135191|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.085|STANDARD_ERROR_OF_MEAN|0.1024|||TWO_SIDED|95.0|-0.122|0.292|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 10 hours|||0.292|-0.122|
71135192|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.072|STANDARD_ERROR_OF_MEAN|0.1125|||TWO_SIDED|95.0|-0.155|0.3|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 5 minutes|||0.300|-0.155|
71135193|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.051|STANDARD_ERROR_OF_MEAN|0.1303|||TWO_SIDED|95.0|-0.213|0.314|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 10 minutes|||0.314|-0.213|
70947976|NCT01407276|141396847|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.64|||||TWO_SIDED|90.0|0.54|0.76|||GMR of Panel E:Panel F|||||0.76|0.54|
70947977|NCT01407276|141396847|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|0.53|||||TWO_SIDED|90.0|0.39|0.71|||GMR of Panel G:Panel H|||||0.71|0.39|
70947978|NCT01407276|141396847|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|0.51|||||TWO_SIDED|90.0|0.38|0.68|||GMR of Panel G:Panel H|||||0.68|0.38|
70947979|NCT01407276|141396848|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|0.93|||||TWO_SIDED|90.0|0.74|1.18|||GMR of Panel A:Panel B|||||1.18|0.74|
70947980|NCT01407276|141396848|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|0.73|||||TWO_SIDED|90.0|0.55|0.96|||GMR of Panel C:Panel D|||||0.96|0.55|
71135194|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.142|STANDARD_ERROR_OF_MEAN|0.1572|||TWO_SIDED|95.0|-0.176|0.461|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 15 minutes|||0.461|-0.176|
70862827|NCT01920555|141212619|SUPERIORITY||Mean Difference (Final Values)|-2.04||||0.72|TWO_SIDED|95.0|-5.04|0.95||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.95|-5.04|0.72
70862828|NCT01920555|141212619|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.8|TWO_SIDED|95.0|-3.18|2.46||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||2.46|-3.18|0.80
70862829|NCT01920555|141212619|SUPERIORITY||Mean Difference (Final Values)|-3.12||||0.14|TWO_SIDED|95.0|-5.97|-0.44||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.44|-5.97|0.14
70862830|NCT01920555|141212619|SUPERIORITY||Mean Difference (Final Values)|-1.84||||0.72|TWO_SIDED|95.0|-4.65|0.96||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.96|-4.65|0.72
70862831|NCT01920555|141212620|SUPERIORITY||Mean Difference (Final Values)|-5.15||||0.33|TWO_SIDED|95.0|-12.44|2.14||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were four pairwise comparisons of interest (see Analysis 1-4), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||2.14|-12.44|0.33
70862832|NCT01920555|141212620|SUPERIORITY||Mean Difference (Final Values)|-2.16||||0.53|TWO_SIDED|95.0|-9.03|4.72||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were four pairwise comparisons of interest (see Analysis 1-4), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||4.72|-9.03|0.53
70862833|NCT01920555|141212620|SUPERIORITY||Mean Difference (Final Values)|-9.85||||0.02|TWO_SIDED|95.0|-16.56|-3.15||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were four pairwise comparisons of interest (see Analysis 1-4), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-3.15|-16.56|0.02
70862834|NCT01920555|141212620|SUPERIORITY||Mean Difference (Final Values)|-7.72||||0.08|TWO_SIDED|95.0|-14.52|-0.93||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were four pairwise comparisons of interest (see Analysis 1-4), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.93|-14.52|0.08
70862835|NCT01920555|141212621|SUPERIORITY||Mean Difference (Final Values)|-1.03||||0.08|TWO_SIDED|95.0|-1.83|-0.22|||Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.22|-1.83|0.08
70947981|NCT01407276|141396848|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.42|||||TWO_SIDED|90.0|0.33|0.54|||GMR of Panel E:Panel F|||||0.54|0.33|
71135195|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.094|STANDARD_ERROR_OF_MEAN|0.1494|||TWO_SIDED|95.0|-0.208|0.396|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 20 minutes|||0.396|-0.208|
71135196|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.058|STANDARD_ERROR_OF_MEAN|0.1332|||TWO_SIDED|95.0|-0.212|0.327|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 30 minutes|||0.327|-0.212|
71135197|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.065|STANDARD_ERROR_OF_MEAN|0.143|||TWO_SIDED|95.0|-0.224|0.354|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 45 minutes|||0.354|-0.224|
71135198|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.016|STANDARD_ERROR_OF_MEAN|0.1283|||TWO_SIDED|95.0|-0.276|0.243|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 1 hour|||0.243|-0.276|
71135199|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.017|STANDARD_ERROR_OF_MEAN|0.1118|||TWO_SIDED|95.0|-0.209|0.244|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 1.5 hours|||0.244|-0.209|
71135200|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.148|STANDARD_ERROR_OF_MEAN|0.0998|||TWO_SIDED|95.0|-0.35|0.053|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 2 hours|||0.053|-0.350|
71135201|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.086|STANDARD_ERROR_OF_MEAN|0.0829|||TWO_SIDED|95.0|-0.253|0.082|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 2.5 hours|||0.082|-0.253|
71135202|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.0843|||TWO_SIDED|95.0|-0.211|0.13|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 3 hours|||0.130|-0.211|
71135203|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.161|0.202|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 3.5 hours|||0.202|-0.161|
71135204|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.005|STANDARD_ERROR_OF_MEAN|0.0947|||TWO_SIDED|95.0|-0.196|0.186|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 4 hour|||0.186|-0.196|
71135205|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.113|STANDARD_ERROR_OF_MEAN|0.1079|||TWO_SIDED|95.0|-0.105|0.33|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 4.5 hours|||0.330|-0.105|
70862836|NCT01920555|141212621|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.82|TWO_SIDED|95.0|-1.02|0.51||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.51|-1.02|0.82
70947982|NCT01407276|141396849|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|0.86|||||TWO_SIDED|90.0|0.69|1.07|||GMR of Panel A:Panel B|||||1.07|0.69|
70947983|NCT01407276|141396849|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|0.9|||||TWO_SIDED|90.0|0.7|1.15|||GMR of Panel C:Panel D|||||1.15|0.70|
70947984|NCT01407276|141396849|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.5|||||TWO_SIDED|90.0|0.37|0.67|||GMR of Panel E:Panel F|||||0.67|0.37|
70947985|NCT01407276|141396850|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|0.86|||||TWO_SIDED|90.0|0.69|1.07|||GMR of Panel A:Panel B|||||1.07|0.69|
71135206|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.0968|||TWO_SIDED|95.0|-0.065|0.326|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 5 hours|||0.326|-0.065|
71135207|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.007|STANDARD_ERROR_OF_MEAN|0.1019|||TWO_SIDED|95.0|-0.213|0.199|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 5.5 hours|||0.199|-0.213|
71135208|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.178|STANDARD_ERROR_OF_MEAN|0.1138|||TWO_SIDED|95.0|-0.052|0.407|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 6 hours|||0.407|-0.052|
71135209|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.135|STANDARD_ERROR_OF_MEAN|0.1065|||TWO_SIDED|95.0|-0.08|0.351|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 6.5 hours|||0.351|-0.080|
71135210|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.179|STANDARD_ERROR_OF_MEAN|0.1198|||TWO_SIDED|95.0|-0.062|0.421|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 7 hour|||0.421|-0.062|
71135211|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.146|STANDARD_ERROR_OF_MEAN|0.1373|||TWO_SIDED|95.0|-0.131|0.423|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 7.5 hours|||0.423|-0.131|
71135212|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.168|STANDARD_ERROR_OF_MEAN|0.1203|||TWO_SIDED|95.0|-0.075|0.411|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 8 hours|||0.411|-0.075|
71135213|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.222|STANDARD_ERROR_OF_MEAN|0.1331|||TWO_SIDED|95.0|-0.047|0.49|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 8.5 hours|||0.490|-0.047|
71135214|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.143|STANDARD_ERROR_OF_MEAN|0.1206|||TWO_SIDED|95.0|-0.1|0.387|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 9 hours|||0.387|-0.100|
71135215|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.187|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.035|0.41|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 9.5 hours|||0.410|-0.035|
71135216|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.168|STANDARD_ERROR_OF_MEAN|0.1039|||TWO_SIDED|95.0|-0.042|0.378|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 10 hours|||0.378|-0.042|
71135217|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.221|STANDARD_ERROR_OF_MEAN|0.1036|||TWO_SIDED|95.0|0.011|0.431|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 5 minutes|||0.431|0.011|
71135218|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.244|STANDARD_ERROR_OF_MEAN|0.1236|||TWO_SIDED|95.0|-0.006|0.494|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 10 minutes|||0.494|-0.006|
71135219|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.255|STANDARD_ERROR_OF_MEAN|0.1445|||TWO_SIDED|95.0|-0.038|0.548|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 15 minutes|||0.548|-0.038|
71135220|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.233|STANDARD_ERROR_OF_MEAN|0.1436|||TWO_SIDED|95.0|-0.057|0.524|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 20 minutes|||0.524|-0.057|
71135221|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.219|STANDARD_ERROR_OF_MEAN|0.1262|||TWO_SIDED|95.0|-0.036|0.474|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 30 minutes|||0.474|-0.036|
71135222|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.294|STANDARD_ERROR_OF_MEAN|0.1355|||TWO_SIDED|95.0|0.019|0.568|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 45 minutes|||0.568|0.019|
71135223|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.227|STANDARD_ERROR_OF_MEAN|0.1216|||TWO_SIDED|95.0|-0.019|0.473|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 1 hour|||0.473|-0.019|
71135224|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.204|STANDARD_ERROR_OF_MEAN|0.1059|||TWO_SIDED|95.0|-0.01|0.418|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 1.5 hours|||0.418|-0.010|
71135225|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.116|STANDARD_ERROR_OF_MEAN|0.0947|||TWO_SIDED|95.0|-0.075|0.308|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 2 hours|||0.308|-0.075|
71135226|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.027|STANDARD_ERROR_OF_MEAN|0.0805|||TWO_SIDED|95.0|-0.136|0.19|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 2.5 hours|||0.190|-0.136|
71135227|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.046|STANDARD_ERROR_OF_MEAN|0.0801|||TWO_SIDED|95.0|-0.116|0.208|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 3 hours|||0.208|-0.116|
71135228|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.074|STANDARD_ERROR_OF_MEAN|0.0855|||TWO_SIDED|95.0|-0.099|0.247|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 3.5 hour|||0.247|-0.099|
71135229|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.131|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.051|0.313|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 4 hours|||0.313|-0.051|
71135230|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.204|STANDARD_ERROR_OF_MEAN|0.1025|||TWO_SIDED|95.0|-0.004|0.411|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 4.5 hours|||0.411|-0.004|
70947986|NCT01407276|141396850|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|0.9|||||TWO_SIDED|90.0|0.7|1.15|||GMR of Panel C:Panel D|||||1.15|0.70|
71135231|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.181|STANDARD_ERROR_OF_MEAN|0.0918|||TWO_SIDED|95.0|-0.004|0.367|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 5 hours|||0.367|-0.004|
71135232|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.178|STANDARD_ERROR_OF_MEAN|0.0967|||TWO_SIDED|95.0|-0.018|0.373|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 5.5 hours|||0.373|-0.018|
70862837|NCT01920555|141212621|SUPERIORITY||Mean Difference (Final Values)|-1.28||||0.0072|TWO_SIDED|95.0|-2.02|-0.54||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.54|-2.02|0.00720
70947987|NCT01407276|141396850|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.5|||||TWO_SIDED|90.0|0.37|0.67|||GMR of Panel E:Panel F|||||0.67|0.37|
70862838|NCT01920555|141212621|SUPERIORITY||Mean Difference (Final Values)|-1.05||||0.04884|TWO_SIDED|95.0|-1.81|-0.29||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.29|-1.81|0.04884
70862839|NCT01920555|141212621|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.48|TWO_SIDED|95.0|-1.7|0.28||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.28|-1.70|0.48
70862840|NCT01920555|141212621|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.82|TWO_SIDED|95.0|-1.32|0.55||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.55|-1.32|0.82
70862841|NCT01920555|141212621|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.16|TWO_SIDED|95.0|-1.91|-0.09||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.09|-1.91|0.16
70862842|NCT01920555|141212621|SUPERIORITY||Mean Difference (Final Values)|-0.86||||0.27|TWO_SIDED|95.0|-1.78|0.07||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.07|-1.78|0.27
70862843|NCT01920555|141212622|SUPERIORITY||Mean Difference (Net)|-0.54||||0.54|TWO_SIDED|95.0|-1.25|0.17||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.17|-1.25|0.54
70862844|NCT01920555|141212622|SUPERIORITY||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-0.78|0.58||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.58|-0.78|1.00
70862845|NCT01920555|141212622|SUPERIORITY||Mean Difference (Final Values)|-0.98||||0.03|TWO_SIDED|95.0|-1.64|-0.31||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.31|-1.64|0.03
70862846|NCT01920555|141212622|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.54|TWO_SIDED|95.0|-1.24|0.11||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.11|-1.24|0.54
70872172|NCT01438957|141229578|SUPERIORITY|||||||0.737|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.737
70947988|NCT02446613|141396855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_DEVIATION|0.007|||TWO_SIDED|95.0|-1.41|5.43|||||The posterior probability statement value for change from baseline in post-challenge TNSS ≤0 was 0.1071.|||5.43|-1.41|
71135233|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.288|STANDARD_ERROR_OF_MEAN|0.1079|||TWO_SIDED|95.0|0.07|0.506|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 6 hours|||0.506|0.070|
71135234|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.283|STANDARD_ERROR_OF_MEAN|0.1011|||TWO_SIDED|95.0|0.079|0.488|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 6.5 hours|||0.488|0.079|
71135235|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.386|STANDARD_ERROR_OF_MEAN|0.1137|||TWO_SIDED|95.0|0.157|0.616|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 7 hour|||0.616|0.157|
71135236|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.372|STANDARD_ERROR_OF_MEAN|0.1306|||TWO_SIDED|95.0|0.108|0.636|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 7.5 hours|||0.636|0.108|
71135237|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.458|STANDARD_ERROR_OF_MEAN|0.1142|||TWO_SIDED|95.0|0.227|0.688|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 8 hours|||0.688|0.227|
70862847|NCT01920555|141212622|SUPERIORITY||Mean Difference (Final Values)|-0.19||||1|TWO_SIDED|95.0|-0.96|0.57||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.57|-0.96|1.00
71135238|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.509|STANDARD_ERROR_OF_MEAN|0.1264|||TWO_SIDED|95.0|0.254|0.765|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 8.5 hours|||0.765|0.254|
70872173|NCT01438957|141229579|SUPERIORITY|||||||0.11|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.11
70947989|NCT02446613|141396856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|0.007|||TWO_SIDED|95.0|-1.98|3.75|||||The posterior probability statement value for change from baseline in post-challenge TNSS ≤0 was 0.2417.|||3.75|-1.98|
71135239|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.492|STANDARD_ERROR_OF_MEAN|0.1144|||TWO_SIDED|95.0|0.261|0.723|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 9 hours|||0.723|0.261|
71135240|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.414|STANDARD_ERROR_OF_MEAN|0.1042|||TWO_SIDED|95.0|0.203|0.625|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 9.5 hours|||0.625|0.203|
71135241|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.44|STANDARD_ERROR_OF_MEAN|0.0984|||TWO_SIDED|95.0|0.241|0.639|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 10 hours|||0.639|0.241|
71135242|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.348|STANDARD_ERROR_OF_MEAN|0.1056|||TWO_SIDED|95.0|0.135|0.562|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 5 minutes|||0.562|0.135|
71135243|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.494|STANDARD_ERROR_OF_MEAN|0.1273|||TWO_SIDED|95.0|0.237|0.751|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 10 minutes|||0.751|0.237|
71135244|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.499|STANDARD_ERROR_OF_MEAN|0.1484|||TWO_SIDED|95.0|0.199|0.8|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 15 minutes|||0.800|0.199|
71135245|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.573|STANDARD_ERROR_OF_MEAN|0.1481|||TWO_SIDED|95.0|0.274|0.872|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 20 minutes|||0.872|0.274|
71135246|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.488|STANDARD_ERROR_OF_MEAN|0.1303|||TWO_SIDED|95.0|0.225|0.751|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 30 minutes|||0.751|0.225|
71135247|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.38|STANDARD_ERROR_OF_MEAN|0.1398|||TWO_SIDED|95.0|0.098|0.663|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 45 minutes|||0.663|0.098|
71135248|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.342|STANDARD_ERROR_OF_MEAN|0.1254|||TWO_SIDED|95.0|0.089|0.596|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 1 hour|||0.596|0.089|
71135249|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.218|STANDARD_ERROR_OF_MEAN|0.1094|||TWO_SIDED|95.0|-0.003|0.439|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 1.5 hours|||0.439|-0.003|
71135250|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.127|STANDARD_ERROR_OF_MEAN|0.0974||||95.0|-0.07|0.323|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 2 hours|||0.323|-0.070|
71135251|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.058|STANDARD_ERROR_OF_MEAN|0.0818|||TWO_SIDED|95.0|-0.107|0.223|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 2.5 hours|||0.223|-0.107|
71135252|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.027|STANDARD_ERROR_OF_MEAN|0.0821|||TWO_SIDED|95.0|-0.192|0.139|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 3 hours|||0.139|-0.192|
71135253|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.091|STANDARD_ERROR_OF_MEAN|0.0876|||TWO_SIDED|95.0|-0.085|0.268|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 3.5 hours|||0.268|-0.085|
71135254|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.084|STANDARD_ERROR_OF_MEAN|0.0921|||TWO_SIDED|95.0|-0.102|0.269|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 4 hour|||0.269|-0.102|
70947990|NCT02446613|141396857|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.4|STANDARD_DEVIATION|0.007|||TWO_SIDED|95.0|-1.08|1.87|||||The posterior probability statement value for change from baseline in post-challenge TNSS ≤0 was 0.2876.|||1.87|-1.08|
71135255|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.249|STANDARD_ERROR_OF_MEAN|0.105|||TWO_SIDED|95.0|0.038|0.461|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 4.5 hours|||0.461|0.038|
71135256|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.238|STANDARD_ERROR_OF_MEAN|0.0945|||TWO_SIDED|95.0|0.047|0.429|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 5 hours|||0.429|0.047|
71135257|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.315|STANDARD_ERROR_OF_MEAN|0.0995|||TWO_SIDED|95.0|0.114|0.516|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 5.5 hours|||0.516|0.114|
71135258|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.367|STANDARD_ERROR_OF_MEAN|0.1111|||TWO_SIDED|95.0|0.143|0.591|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 6 hours|||0.591|0.143|
71135259|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.361|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|95.0|0.151|0.571|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 6.5 hours|||0.571|0.151|
71135260|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.367|STANDARD_ERROR_OF_MEAN|0.1168|||TWO_SIDED|95.0|0.131|0.602|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 7 hour|||0.602|0.131|
71135261|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.424|STANDARD_ERROR_OF_MEAN|0.1336|||TWO_SIDED|95.0|0.155|0.694|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 7.5 hours|||0.694|0.155|
71135262|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.556|STANDARD_ERROR_OF_MEAN|0.1174|||TWO_SIDED|95.0|0.319|0.793|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 8 hours|||0.793|0.319|
71135263|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.593|STANDARD_ERROR_OF_MEAN|0.1297||||95.0|0.331|0.854|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 8.5 hours|||0.854|0.331|
71135264|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.559|STANDARD_ERROR_OF_MEAN|0.1177|||TWO_SIDED|95.0|0.322|0.797|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 9 hours|||0.797|0.322|
71135265|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.522|STANDARD_ERROR_OF_MEAN|0.1076||||95.0|0.304|0.739|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 9.5 hours|||0.739|0.304|
71135266|NCT00857857|141772214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.514|STANDARD_ERROR_OF_MEAN|0.1017||||95.0|0.308|0.719|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 10 hours|||0.719|0.308|
71135267|NCT00857857|141772216|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.295|STANDARD_ERROR_OF_MEAN|0.1038||||95.0|0.086|0.503|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at Day 7|||0.503|0.086|
70947991|NCT02446613|141396858|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.9|STANDARD_DEVIATION|0.006|||TWO_SIDED|95.0|-1.86|5.34|||||The posterior probability statement value for change from baseline in post-challenge TNSS ≤0 was 0.1453.|||5.34|-1.86|
70947992|NCT02446613|141396859|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.6|STANDARD_DEVIATION|0.006|||TWO_SIDED|95.0|-10.7|19.71|||||The posterior probability statement value for percentage reduction in the reductions of PNIF ≤0 was 0.2665.|||19.71|-10.70|
70947993|NCT02446613|141396860|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.3|STANDARD_DEVIATION|0.007|||TWO_SIDED|95.0|-14.97|24.38|||||The posterior probability statement value for percentage reduction in the reductions of PNIF ≤0 was 0.3266|||24.38|-14.97|
71135268|NCT00857857|141772216|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.185|STANDARD_ERROR_OF_MEAN|0.0884|||TWO_SIDED|95.0|0.007|0.363|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at Day 13|||0.363|0.007|
70862848|NCT01920555|141212622|SUPERIORITY||Mean Difference (Final Values)|-0.21||||1|TWO_SIDED|95.0|-0.93|0.51||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.51|-0.93|1.00
70862849|NCT01920555|141212622|SUPERIORITY||Mean Difference (Final Values)|-0.64||||0.52|TWO_SIDED|95.0|-1.35|0.06||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.06|-1.35|0.52
70947994|NCT02446613|141396861|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.1|STANDARD_DEVIATION|0.008|||TWO_SIDED|95.0|-17.47|19.2|||||The posterior probability statement value for percentage reduction in the reductions of PNIF ≤0 was 0.4528|||19.20|-17.47|
70947995|NCT02446613|141396862|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|6.6|STANDARD_DEVIATION|0.007|||TWO_SIDED|95.0|-13.69|28.04|||||The posterior probability statement value for percentage reduction in the reductions of PNIF ≤0 was 0.2525|||28.04|-13.69|
71135269|NCT00857857|141772216|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.144|STANDARD_ERROR_OF_MEAN|0.1026|||TWO_SIDED|95.0|-0.062|0.351|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at Day 14|||0.351|-0.062|
71135270|NCT00857857|141772216|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.0979|||TWO_SIDED|95.0|0.133|0.527|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at Day 7|||0.527|0.133|
71135271|NCT00857857|141772216|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.081|STANDARD_ERROR_OF_MEAN|0.0856|||TWO_SIDED|95.0|-0.092|0.253|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at Day 13|||0.253|-0.092|
71135272|NCT00857857|141772216|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.126|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.076|0.327|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at Day 14|||0.327|-0.076|
71135273|NCT00857857|141772216|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.297|STANDARD_ERROR_OF_MEAN|0.0976|||TWO_SIDED|95.0|0.1|0.493|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at Day 7|||0.493|0.100|
70947996|NCT01062269|141396864|SUPERIORITY_OR_OTHER||||||<|0.05||||||Differences between test products were assessed by repeated measures analysis of variance. If sequence was not found to be statistically significant(p\>0.05),then it was removed from the final model.|measures analysis of variance|Differences between test powders assessed by repeated measures analysis of variance, pairwise comparisons between treatments by Scheffe procedure.||"The BASA scale components were derived from the parameters best shown to differentiate acceptability between different BAS preparations (taste and texture),as well as other parameters useful for differentiating between different BAS preparations(appearance and mixability). The scale was then weighted based upon an Importance of Acceptability questionnaire regarding the individual scale components. The developed scale should reasonably allow for future comparisons of differing BAS formulations."||||<0.05
70947997|NCT00745498|141396867|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||With study power of 80%, a significance level of 0.05, and the assumption that IVB injection will decrease postoperative VH incidence from 35% to 10%, a sample size of 40 patients for each group was calculated.||||<0.05
70947998|NCT03178045|141396881|OTHER|Multivariable Logistic Regression|Estimated Increase|0.23|||||TWO_SIDED|95.0|-3.1|3.6||||||||3.6|-3.1|
71135274|NCT00857857|141772216|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.256|STANDARD_ERROR_OF_MEAN|0.0859|||TWO_SIDED|95.0|0.083|0.429|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at Day 13|||0.429|0.083|
71135275|NCT00857857|141772216|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.462|STANDARD_ERROR_OF_MEAN|0.0991|||TWO_SIDED|95.0|0.262|0.662|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at Day 14|||0.662|0.262|
70947999|NCT03178045|141396882|OTHER|Multivariable logistic regression|Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.69|1.31||||||||1.31|0.69|
70948000|NCT03178045|141396883|OTHER|Longitudinal mixed effects regression|Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.6|1.32||||||||1.32|0.60|
71135276|NCT00857857|141772216|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.323|STANDARD_ERROR_OF_MEAN|0.0982|||TWO_SIDED|95.0|0.125|0.52|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at Day 7|||0.520|0.125|
71135277|NCT00857857|141772216|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.229|STANDARD_ERROR_OF_MEAN|0.0858|||TWO_SIDED|95.0|0.057|0.402|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at Day 13|||0.402|0.057|
71135278|NCT00857857|141772216|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.372|STANDARD_ERROR_OF_MEAN|0.0991|||TWO_SIDED|95.0|0.172|0.572|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at Day 14|||0.572|0.172|
71135279|NCT00857857|141772226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.482|||TWO_SIDED|95.0|-1.3|0.66|||||Doubling dose differences, that is a treatment doubling dose difference of 1 indicates that the concentration of methacholine required to cause a 20% fall in FEV1 in one treatment is twice that in the other (log2\[2\] = 1).|||0.66|-1.30|
71135280|NCT00857857|141772226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.495|||TWO_SIDED|95.0|-0.73|1.28|||||Doubling dose differences, that is a treatment doubling dose difference of 1 indicates that the concentration of methacholine required to cause a 20% fall in FEV1 in one treatment is twice that in the other (log2\[2\] = 1).|||1.28|-0.73|
71135281|NCT00857857|141772226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.28|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|0.36|2.19|||||Doubling dose differences, that is a treatment doubling dose difference of 1 indicates that the concentration of methacholine required to cause a 20% fall in FEV1 in one treatment is twice that in the other (log2\[2\] = 1).|||2.19|0.36|
71135282|NCT00857857|141772226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.79|STANDARD_ERROR_OF_MEAN|0.469|||TWO_SIDED|95.0|0.84|2.75|||||Doubling dose differences, that is a treatment doubling dose difference of 1 indicates that the concentration of methacholine required to cause a 20% fall in FEV1 in one treatment is twice that in the other (log2\[2\] = 1).|||2.75|0.84|
71135283|NCT02709330|141772259|OTHER|||||||0.99|||||||Kolmogorov-Smirnov Test|||Matched historical controls will be identified from the PatientsLikeMe database.||||0.99
71135284|NCT02709330|141772260|OTHER|||||||0.0748|||||||ANOVA|||||||0.0748
71135285|NCT02709330|141772261|OTHER||||||<|1e-05|||||||Lin's Concordance|||||||<0.00001
71135286|NCT02709330|141772265|OTHER||||||<|1e-05|||||||Lin's Concordance|||||||<0.00001
71135287|NCT04317040|141772288|OTHER|Hazard ratio (HR) and the associated 95% CIs were calculated based on Cox Regression model and p-value was calculated based on log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|1.398||||0.0367|TWO_SIDED|95.0|1.02|1.918|||Log Rank||Cox-Regression Model|||1.918|1.020|0.0367
71135288|NCT04317040|141772290|OTHER|Risk difference (RD) and the associated 95% CIs were calculated based on Mantel-Haenszel method and p-value was calculated based on Chi-squared test, in accordance with the statistical analysis plan.|Risk Difference (RD)|-0.0555||||0.3281|TWO_SIDED|95.0|-0.1665|0.0555|||Chi-squared||Mantel-Haenszel method|||0.0555|-0.1665|0.3281
71135289|NCT04317040|141772291|OTHER|Hazard ratio (HR) and the associated 95% CIs were calculated based on Cox Regression model and p-value was calculated based on log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.558||||0.0306|TWO_SIDED|95.0|0.327|0.954|||Log Rank||Cox Regression Model|||0.954|0.327|0.0306
71135290|NCT04317040|141772292|OTHER|Risk difference (RD) and the associated 95% CIs were calculated based on Mantel-Haenszel method and p-value was calculated based on Chi-squared test, in accordance with the statistical analysis plan.|Risk Difference (RD)|0.027||||0.4491|TWO_SIDED|95.0|-0.043|0.097|||Chi-squared||Mantel-Haenszel method used to report all-cause mortality by Day 15|Day 15||0.0970|-0.0430|0.4491
71135291|NCT04317040|141772292|OTHER|Risk difference (RD) and the associated 95% CIs were calculated based on Mantel-Haenszel method and p-value was calculated based on Chi-squared test, in accordance with the statistical analysis plan.|Risk Difference (RD)|-0.0146||||0.7512|TWO_SIDED|95.0|-0.1049|0.0756|||Chi-squared||Mantel-Haenszel method used to report all-cause mortality by Day 29|Day 29||0.0756|-0.1049|0.7512
71135292|NCT04317040|141772295|OTHER|Hazard ratio (HR) and the associated 95% CIs were calculated based on Cox Regression model and p-value was calculated based on log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|1.416||||0.0311|TWO_SIDED|95.0|1.031|1.945|||Log Rank||Cox Regression model|||1.945|1.031|0.0311
71135293|NCT04308941|141772339|OTHER|The mean and standard deviation was analyzed.||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
71135294|NCT02366195|141772343|OTHER|||||||0.387|||||||Regression, Logistic|||||||0.387
71135295|NCT02366195|141772344|OTHER|Primary completion data.||||||0.056|||||||Regression, Logistic|||||||0.056
71135296|NCT02366195|141772344|OTHER|Final analysis data.||||||0.222|||||||Regression, Logistic|||||||0.222
71135297|NCT02366195|141772345|OTHER|Primary completion data||||||0.335|||||||Cox proportional hazards|||||||0.335
71135298|NCT02366195|141772345|OTHER|Final analysis data||||||0.597|||||||Cox proportional hazards|||||||0.597
71135299|NCT02366195|141772346|OTHER|Primary completion||||||0.82|||||||Fisher's Z transformation|||||||0.82
71135300|NCT02366195|141772346|OTHER|Final analysis data||||||0.9|||||||Fisher's Z transformation|||||||0.90
71135301|NCT02366195|141772347|OTHER|Primary completion data||||||0.66|||||||Regression, Logistic|||||||0.660
71135302|NCT02366195|141772347|OTHER|Final analysis data||||||0.881|||||||Regression, Logistic|||||||0.881
71135303|NCT02366195|141772348|OTHER|Primary completion data||||||0.974|||||||Regression, Logistic|||||||0.974
71135304|NCT02366195|141772348|OTHER|Final analysis data||||||0.612|||||||Regression, Logistic|||||||0.612
71135305|NCT02366195|141772349|OTHER|Primary completion data||||||0.626|||||||Cox proportional hazards|||||||0.626
71135306|NCT02366195|141772349|OTHER|Final analysis data||||||0.579|||||||Cox proportional hazards|||||||0.579
71135307|NCT02366195|141772350|OTHER|Primary completion data||||||0.18|||||||Pearson's correlation coefficient|||||||0.18
71135308|NCT02366195|141772350|OTHER|Final analysis data||||||0.14|||||||Pearson's correlation coefficient|||||||0.14
71135309|NCT00740207|141772361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.7142|TWO_SIDED|95.0|-1.3|0.9|||t-test, 2 sided|||Paired t-test to compare difference between the investigational product's mean change from predose to postdose||0.9|-1.3|0.7142
71135310|NCT00740207|141772362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.0||||0.1698|TWO_SIDED|95.0|-79.2|-0.8|||Fisher Exact|||Paired t-test to compare the difference in percentage between the portions of patients who had motion artifacts.||-0.8|-79.2|0.1698
71135311|NCT00740207|141772363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.0||||1|TWO_SIDED|95.0|-28.6|8.6|||Fisher Exact|||Paired t-test to compare difference in percentage between the number of participants requiring repeat injections||8.6|-28.6|1.000
71135312|NCT03710642|141772439|SUPERIORITY||Mean Difference (Net)|-0.008096||||0.9904|TWO_SIDED||||||Regression, Linear|||||||0.9904
71135313|NCT03710642|141772440|SUPERIORITY||Mean Difference (Net)|-11.54||||0.30328|TWO_SIDED||||||Regression, Linear|||||||0.30328
71135314|NCT03710642|141772441|SUPERIORITY||Mean Difference (Net)|0.31122||||0.21981|TWO_SIDED||||||Regression, Linear|||||||0.21981
71135315|NCT03710642|141772442|SUPERIORITY||Cox Proportional Hazard|-0.36277||||0.6366|TWO_SIDED||||||Regression, Cox|||||||0.6366
70872174|NCT01438957|141229580|SUPERIORITY|||||||0.567|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.567
70948001|NCT02706847|141396905|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|36.2|||<|0.001|TWO_SIDED|95.0|26.2|46.2||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||46.2|26.2|<0.001
71135316|NCT03710642|141772443|SUPERIORITY||Slope|-0.12842|STANDARD_ERROR_OF_MEAN|1.39602||0.9267|TWO_SIDED||||||Regression, Logistic|||||||0.9267
71135317|NCT03710642|141772444|SUPERIORITY||Mean Difference (Net)|3.0694||||0.2038|TWO_SIDED||||||Regression, Linear|||||||0.2038
71135318|NCT03710642|141772445|SUPERIORITY||Mean Difference (Net)|-3.388||||0.54133|TWO_SIDED||||||Regression, Linear|||||||0.54133
71135319|NCT02538042|141772454|SUPERIORITY|||||||0.39|||||||ANOVA|||||||0.39
71135320|NCT02052752|141772539|SUPERIORITY_OR_OTHER|||||||0.283||95.0|||||ANCOVA|||The ANCOVA results for the primary endpoint with treatment group as a main effect and average baseline value as a covariate showed no statistically significant differences in the percentage change from baseline in swelling of the target lesions between the 3% BPO group and the vehicle control group at Day 4 for the ITT population||||0.283
71135321|NCT03201419|141772586|SUPERIORITY||Mean Difference|-0.3|||||TWO_SIDED|95.0|-0.54|-0.07||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||-0.07|-0.54|
71135322|NCT03201419|141772586|SUPERIORITY||Mean Difference|-0.23|||||TWO_SIDED|95.0|-0.46|-0.02||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||-0.02|-0.46|
71135323|NCT03201419|141772586|SUPERIORITY||Mean Difference|-0.14|||||TWO_SIDED|95.0|-0.36|0.0||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||-0.00|-0.36|
71135324|NCT03201419|141772586|SUPERIORITY||Mean Difference|-0.04|||||TWO_SIDED|95.0|-0.23|0.0||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||-0.00|-0.23|
71135325|NCT03201419|141772586|SUPERIORITY||Mean Difference|-0.02|||||TWO_SIDED|95.0|-0.14|0.0||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||-0.00|-0.14|
71135326|NCT03201419|141772586|SUPERIORITY||Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.07|0.0||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||-0.00|-0.07|
71135327|NCT03201419|141772587|SUPERIORITY||Mean Difference|-0.139||||0.4214|TWO_SIDED|95.0|-0.48|0.201||Threshold for significance at 0.05 level.|MMRM|||||0.201|-0.480|0.4214
71135328|NCT03201419|141772587|SUPERIORITY||Mean Difference|-0.587||||0.0101|TWO_SIDED|95.0|-1.034|-0.141||Threshold for significance at 0.05 level.|MMRM|||||-0.141|-1.034|0.0101
71135329|NCT03201419|141772587|SUPERIORITY||Mean Difference|-0.148||||0.5203|TWO_SIDED|95.0|-0.599|0.304||Threshold for significance at 0.05 level.|MMRM|||||0.304|-0.599|0.5203
71135330|NCT03201419|141772587|SUPERIORITY||Mean Difference|0.055||||0.8483|TWO_SIDED|95.0|-0.508|0.617||Threshold for significance at 0.05 level.|MMRM|||||0.617|-0.508|0.8483
71135331|NCT03201419|141772587|SUPERIORITY||Mean Difference|-0.147||||0.6357|TWO_SIDED|95.0|-0.759|0.464||Threshold for significance at 0.05 level.|MMRM|||||0.464|-0.759|0.6357
71135332|NCT03201419|141772587|SUPERIORITY||Mean Difference|0.25||||0.2222|TWO_SIDED|95.0|-0.152|0.652||Threshold for significance at 0.05 level.|MMRM|||||0.652|-0.152|0.2222
71135333|NCT03201419|141772588|SUPERIORITY||Mean Difference|-0.166||||0.2909|TWO_SIDED|95.0|-0.474|0.143||Threshold for significance at 0.05 level.|MMRM|||||0.143|-0.474|0.2909
71135334|NCT03201419|141772588|SUPERIORITY||Mean Difference|-0.418||||0.044|TWO_SIDED|95.0|-0.824|-0.011||Threshold for significance at 0.05 level.|MMRM|||||-0.011|-0.824|0.0440
71135335|NCT03201419|141772588|SUPERIORITY||Mean Difference|0.128||||0.5438|TWO_SIDED|95.0|-0.288|0.545||Threshold for significance at 0.05 level.|MMRM|||||0.545|-0.288|0.5438
71135336|NCT03201419|141772588|SUPERIORITY||Mean Difference|0.441||||0.096|TWO_SIDED|95.0|-0.079|0.962||Threshold for significance at 0.05 level.|MMRM|||||0.962|-0.079|0.0960
71135337|NCT03201419|141772588|SUPERIORITY||Mean Difference|-0.04||||0.8826|TWO_SIDED|95.0|-0.568|0.488||Threshold for significance at 0.05 level.|MMRM|||||0.488|-0.568|0.8826
71135338|NCT03201419|141772588|SUPERIORITY||Mean Difference|0.394||||0.0344|TWO_SIDED|95.0|0.029|0.759||Threshold for significance at 0.05 level.|MMRM|||||0.759|0.029|0.0344
71135339|NCT03201419|141772589|SUPERIORITY||Mean Difference|-0.132||||0.4732|TWO_SIDED|95.0|-0.496|0.231||Threshold for significance at 0.05 level.|MMRM|||||0.231|-0.496|0.4732
71135340|NCT03201419|141772589|SUPERIORITY||Mean Difference|-0.224||||0.3394|TWO_SIDED|95.0|-0.685|0.237||Threshold for significance at 0.05 level.|MMRM|||||0.237|-0.685|0.3394
71135341|NCT03201419|141772589|SUPERIORITY||Mean Difference|-0.012||||0.96|TWO_SIDED|95.0|-0.488|0.463||Threshold for significance at 0.05 level.|MMRM|||||0.463|-0.488|0.9600
71135342|NCT03201419|141772589|SUPERIORITY||Mean Difference|0.463||||0.1131|TWO_SIDED|95.0|-0.111|1.037||Threshold for significance at 0.05 level.|MMRM|||||1.037|-0.111|0.1131
71135343|NCT03201419|141772589|SUPERIORITY||Mean Difference|-0.124||||0.6853|TWO_SIDED|95.0|-0.729|0.48||Threshold for significance at 0.05 level.|MMRM|||||0.480|-0.729|0.6853
71135344|NCT03201419|141772589|SUPERIORITY||Mean Difference|0.166||||0.4364|TWO_SIDED|95.0|-0.254|0.587||Threshold for significance at 0.05 level.|MMRM|||||0.587|-0.254|0.4364
71135345|NCT03201419|141772590|SUPERIORITY||Mean Difference|-0.299||||0.1106|TWO_SIDED|95.0|-0.667|0.069||Threshold for significance at 0.05 level.|MMRM|||||0.069|-0.667|0.1106
71135346|NCT03201419|141772590|SUPERIORITY||Mean Difference|-0.163||||0.5005|TWO_SIDED|95.0|-0.639|0.313||Threshold for significance at 0.05 level.|MMRM|||||0.313|-0.639|0.5005
71135347|NCT03201419|141772590|SUPERIORITY||Mean Difference|0.107||||0.6604|TWO_SIDED|95.0|-0.372|0.586||Threshold for significance at 0.05 level.|MMRM|||||0.586|-0.372|0.6604
71135348|NCT03201419|141772590|SUPERIORITY||Mean Difference|0.283||||0.3178|TWO_SIDED|95.0|-0.275|0.842||Threshold for significance at 0.05 level.|MMRM|||||0.842|-0.275|0.3178
71135349|NCT03201419|141772590|SUPERIORITY||Mean Difference|-0.096||||0.7561|TWO_SIDED|95.0|-0.701|0.51||Threshold for significance at 0.05 level.|MMRM|||||0.510|-0.701|0.7561
71135350|NCT03201419|141772590|SUPERIORITY||Mean Difference|0.037||||0.8614|TWO_SIDED|95.0|-0.378|0.452||Threshold for significance at 0.05 level.|MMRM|||||0.452|-0.378|0.8614
71135351|NCT03201419|141772591|SUPERIORITY||Odds Ratio (OR)|1.759||||0.117|TWO_SIDED|95.0|0.869|3.56||Threshold for significance at 0.05 level.|Regression, Logistic|||||3.560|0.869|0.117
71135352|NCT03201419|141772591|SUPERIORITY||Odds Ratio (OR)|2.505||||0.048|TWO_SIDED|95.0|1.01|6.214||Threshold for significance at 0.05 level.|Regression, Logistic|||||6.214|1.010|0.048
71135353|NCT03201419|141772591|SUPERIORITY||Odds Ratio (OR)|1.42||||0.46|TWO_SIDED|95.0|0.56|3.602||Threshold for significance at 0.05 level.|Regression, Logistic|||||3.602|0.560|0.460
71135354|NCT03201419|141772591|SUPERIORITY||Odds Ratio (OR)|1.704||||0.367|TWO_SIDED|95.0|0.535|5.427||Threshold for significance at 0.05 level.|Regression, Logistic|||||5.427|0.535|0.367
71135355|NCT03201419|141772591|SUPERIORITY||Odds Ratio (OR)|1.689||||0.407|TWO_SIDED|95.0|0.489|5.825||Threshold for significance at 0.05 level.|Regression, Logistic|||||5.825|0.489|0.407
71135356|NCT03201419|141772591|SUPERIORITY||Odds Ratio (OR)|1.069||||0.876|TWO_SIDED|95.0|0.462|2.473||Threshold for significance at 0.05 level.|Regression, Logistic|||||2.473|0.462|0.876
71135357|NCT03201419|141772592|SUPERIORITY||Odds Ratio (OR)|0.971||||0.937|TWO_SIDED|95.0|0.47|2.005||Threshold for significance at 0.05 level.|Regression, Logistic|||||2.005|0.470|0.937
71135358|NCT03201419|141772592|SUPERIORITY||Odds Ratio (OR)|4.738||||0.028|TWO_SIDED|95.0|1.183|18.968||Threshold for significance at 0.05 level.|Regression, Logistic|||||18.968|1.183|0.028
71135359|NCT03201419|141772592|SUPERIORITY||Odds Ratio (OR)|0.513||||0.166|TWO_SIDED|95.0|0.2|1.318||Threshold for significance at 0.05 level.|Regression, Logistic|||||1.318|0.200|0.166
71135360|NCT03201419|141772592|SUPERIORITY||Odds Ratio (OR)|0.433||||0.174|TWO_SIDED|95.0|0.129|1.447||Threshold for significance at 0.05 level.|Regression, Logistic|||||1.447|0.129|0.174
71135361|NCT03201419|141772592|SUPERIORITY||Odds Ratio (OR)|1.425||||0.608|TWO_SIDED|95.0|0.369|5.512||Threshold for significance at 0.05 level.|Regression, Logistic|||||5.512|0.369|0.608
71135362|NCT03201419|141772592|SUPERIORITY||Odds Ratio (OR)|0.553||||0.171|TWO_SIDED|95.0|0.237|1.292||Threshold for significance at 0.05 level.|Regression, Logistic|||||1.292|0.237|0.171
71135363|NCT03201419|141772593|SUPERIORITY||Odds Ratio (OR)|0.928||||0.85|TWO_SIDED|95.0|0.43|2.003||Threshold for significance at 0.05 level.|Regression, Logistic|||||2.003|0.430|0.850
71135364|NCT03201419|141772593|SUPERIORITY||Odds Ratio (OR)|2.261||||0.15|TWO_SIDED|95.0|0.745|6.862||Threshold for significance at 0.05 level.|Regression, Logistic|||||6.862|0.745|0.150
71135365|NCT03201419|141772593|SUPERIORITY||Odds Ratio (OR)|1.283||||0.632|TWO_SIDED|95.0|0.462|3.566||Threshold for significance at 0.05 level.|Regression, Logistic|||||3.566|0.462|0.632
71135366|NCT03201419|141772593|SUPERIORITY||Odds Ratio (OR)|0.583||||0.363|TWO_SIDED|95.0|0.183|1.863||Threshold for significance at 0.05 level.|Regression, Logistic|||||1.863|0.183|0.363
71135367|NCT03201419|141772593|SUPERIORITY||Odds Ratio (OR)|0.691||||0.555|TWO_SIDED|95.0|0.203|2.359||Threshold for significance at 0.05 level.|Regression, Logistic|||||2.359|0.203|0.555
71135368|NCT03201419|141772593|SUPERIORITY||Odds Ratio (OR)|0.991||||0.984|TWO_SIDED|95.0|0.408|2.405||Threshold for significance at 0.05 level.|Regression, Logistic|||||2.405|0.408|0.984
71135369|NCT03201419|141772594|SUPERIORITY||Odds Ratio (OR)|2.462||||0.046|TWO_SIDED|95.0|1.017|5.961||Threshold for significance at 0.05 level.|Regression, Logistic|||||5.961|1.017|0.046
71135370|NCT03201419|141772594|SUPERIORITY||Odds Ratio (OR)|1.19||||0.745|TWO_SIDED|95.0|0.418|3.386||Threshold for significance at 0.05 level.|Regression, Logistic|||||3.386|0.418|0.745
71135371|NCT03201419|141772594|SUPERIORITY||Odds Ratio (OR)|1.147||||0.79|TWO_SIDED|95.0|0.417|3.155||Threshold for significance at 0.05 level.|Regression, Logistic|||||3.155|0.417|0.790
71135372|NCT03201419|141772594|SUPERIORITY||Odds Ratio (OR)|0.537||||0.293|TWO_SIDED|95.0|0.169|1.71||Threshold for significance at 0.05 level.|Regression, Logistic|||||1.710|0.169|0.293
71135373|NCT03201419|141772594|SUPERIORITY||Odds Ratio (OR)|0.881||||0.843|TWO_SIDED|95.0|0.252|3.076||Threshold for significance at 0.05 level.|Regression, Logistic|||||3.076|0.252|0.843
71135374|NCT03201419|141772594|SUPERIORITY||Odds Ratio (OR)|0.877||||0.763|TWO_SIDED|95.0|0.375|2.053||Threshold for significance at 0.05 level.|Regression, Logistic|||||2.053|0.375|0.763
71135375|NCT03201419|141772595|SUPERIORITY||Odds Ratio (OR)|1.422|||||TWO_SIDED|95.0|0.868|2.597||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||2.597|0.868|
71135376|NCT03201419|141772595|SUPERIORITY||Odds Ratio (OR)|1.373|||||TWO_SIDED|95.0|0.905|2.45||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||2.450|0.905|
71135377|NCT03201419|141772595|SUPERIORITY||Odds Ratio (OR)|1.284|||||TWO_SIDED|95.0|0.927|2.264||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||2.264|0.927|
71135378|NCT03201419|141772595|SUPERIORITY||Odds Ratio (OR)|1.145|||||TWO_SIDED|95.0|0.957|1.896||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||1.896|0.957|
71135379|NCT03201419|141772595|SUPERIORITY||Odds Ratio (OR)|1.079|||||TWO_SIDED|95.0|0.972|1.638||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||1.638|0.972|
71135380|NCT03201419|141772595|SUPERIORITY||Odds Ratio (OR)|1.023|||||TWO_SIDED|95.0|0.991|1.313||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||1.313|0.991|
71135381|NCT03201419|141772596|SUPERIORITY||Mean Difference|0.52||||0.8463|TWO_SIDED|95.0|-4.75|5.78||Threshold for significance at 0.05 level.|MMRM|||||5.78|-4.75|0.8463
71135382|NCT03201419|141772596|SUPERIORITY||Mean Difference|-13.85||||0.0001|TWO_SIDED|95.0|-20.89|-6.81||Threshold for significance at 0.05 level.|MMRM|||||-6.81|-20.89|0.0001
71135383|NCT03201419|141772596|SUPERIORITY||Mean Difference|-2.84||||0.4355|TWO_SIDED|95.0|-9.99|4.32||Threshold for significance at 0.05 level.|MMRM|||||4.32|-9.99|0.4355
71135384|NCT03201419|141772596|SUPERIORITY||Mean Difference|-0.87||||0.8483|TWO_SIDED|95.0|-9.79|8.06||Threshold for significance at 0.05 level.|MMRM|||||8.06|-9.79|0.8483
71135385|NCT03201419|141772596|SUPERIORITY||Mean Difference|-1.61||||0.7336|TWO_SIDED|95.0|-10.91|7.69||Threshold for significance at 0.05 level.|MMRM|||||7.69|-10.91|0.7336
71135386|NCT03201419|141772596|SUPERIORITY||Mean Difference|-0.69||||0.8347|TWO_SIDED|95.0|-7.15|5.78||Threshold for significance at 0.05 level.|MMRM|||||5.78|-7.15|0.8347
71135387|NCT03201419|141772597|SUPERIORITY||Mean Difference|1.59||||0.5695|TWO_SIDED|95.0|-3.9|7.07||Threshold for significance at 0.05 level.|MMRM|||||7.07|-3.90|0.5695
71135388|NCT03201419|141772597|SUPERIORITY||Mean Difference|-3.23||||0.3784|TWO_SIDED|95.0|-10.46|3.99||Threshold for significance at 0.05 level.|MMRM|||||3.99|-10.46|0.3784
71135389|NCT03201419|141772597|SUPERIORITY||Mean Difference|-0.17||||0.9653|TWO_SIDED|95.0|-7.67|7.34||Threshold for significance at 0.05 level.|MMRM|||||7.34|-7.67|0.9653
71135390|NCT03201419|141772597|SUPERIORITY||Mean Difference|2.97||||0.5304|TWO_SIDED|95.0|-6.35|12.29||Threshold for significance at 0.05 level.|MMRM|||||12.29|-6.35|0.5304
71135391|NCT03201419|141772597|SUPERIORITY||Mean Difference|-8.02||||0.0968|TWO_SIDED|95.0|-17.51|1.46||Threshold for significance at 0.05 level.|MMRM|||||1.46|-17.51|0.0968
71135392|NCT03201419|141772597|SUPERIORITY||Mean Difference|0.91||||0.7885|TWO_SIDED|95.0|-5.79|7.62||Threshold for significance at 0.05 level.|MMRM|||||7.62|-5.79|0.7885
71135393|NCT03201419|141772598|SUPERIORITY||Mean Difference|-1.2||||0.6792|TWO_SIDED|95.0|-6.89|4.5||Threshold for significance at 0.05 level.|MMRM|||||4.50|-6.89|0.6792
71135394|NCT03201419|141772598|SUPERIORITY||Mean Difference|-8.39||||0.0276|TWO_SIDED|95.0|-15.84|-0.93||Threshold for significance at 0.05 level.|MMRM|||||-0.93|-15.84|0.0276
71135395|NCT03201419|141772598|SUPERIORITY||Mean Difference|-0.27||||0.9445|TWO_SIDED|95.0|-7.97|7.42||Threshold for significance at 0.05 level.|MMRM|||||7.42|-7.97|0.9445
71135396|NCT03201419|141772598|SUPERIORITY||Mean Difference|2.79||||0.5637|TWO_SIDED|95.0|-6.71|12.28||Threshold for significance at 0.05 level.|MMRM|||||12.28|-6.71|0.5637
71135397|NCT03201419|141772598|SUPERIORITY||Mean Difference|-4.4||||0.387|TWO_SIDED|95.0|-14.39|5.6||Threshold for significance at 0.05 level.|MMRM|||||5.60|-14.39|0.3870
71135398|NCT03201419|141772598|SUPERIORITY||Mean Difference|0.72||||0.8373|TWO_SIDED|95.0|-6.19|7.63||Threshold for significance at 0.05 level.|MMRM|||||7.63|-6.19|0.8373
71135399|NCT03201419|141772599|SUPERIORITY||Mean Difference|0.53||||0.8646|TWO_SIDED|95.0|-5.54|6.59||Threshold for significance at 0.05 level.|MMRM|||||6.59|-5.54|0.8646
71135400|NCT03201419|141772599|SUPERIORITY||Mean Difference|-6.99||||0.087|TWO_SIDED|95.0|-15.0|1.02||Threshold for significance at 0.05 level.|MMRM|||||1.02|-15.00|0.0870
71135401|NCT03201419|141772599|SUPERIORITY||Mean Difference|2.77||||0.51|TWO_SIDED|95.0|-5.5|11.04||Threshold for significance at 0.05 level.|MMRM|||||11.04|-5.50|0.5100
71135402|NCT03201419|141772599|SUPERIORITY||Mean Difference|7.32||||0.1535|TWO_SIDED|95.0|-2.75|17.39||Threshold for significance at 0.05 level.|MMRM|||||17.39|-2.75|0.1535
71135403|NCT03201419|141772599|SUPERIORITY||Mean Difference|-5.14||||0.3369|TWO_SIDED|95.0|-15.66|5.38||Threshold for significance at 0.05 level.|MMRM|||||5.38|-15.66|0.3369
71135404|NCT03201419|141772599|SUPERIORITY||Mean Difference|0.27||||0.9417|TWO_SIDED|95.0|-7.05|7.59||Threshold for significance at 0.05 level.|MMRM|||||7.59|-7.05|0.9417
71135405|NCT03201419|141772600|SUPERIORITY||Median difference|0.0|||||TWO_SIDED|95.0|-1.41|5.47||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||5.47|-1.41|
71135406|NCT03201419|141772600|SUPERIORITY||Median difference|0.0|||||TWO_SIDED|95.0|-0.43|1.19||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||1.19|-0.43|
71135407|NCT03201419|141772600|SUPERIORITY||Median difference|0.0|||||TWO_SIDED|95.0|-0.16|0.5||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.50|-0.16|
71135408|NCT03201419|141772600|SUPERIORITY||Median difference|0.0|||||TWO_SIDED|95.0|-0.03|0.15||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.15|-0.03|
71135409|NCT03201419|141772600|SUPERIORITY||Median difference|0.0|||||TWO_SIDED|95.0|-0.01|0.05||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.05|-0.01|
71135410|NCT03201419|141772600|SUPERIORITY||Median difference|0.0|||||TWO_SIDED|95.0|0.0|0.01||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.01|-0.00|
71135411|NCT03201419|141772601|SUPERIORITY||Mean Difference|5.2||||0.3328|TWO_SIDED|95.0|-5.3|15.7||Threshold for significance at 0.05 level.|ANCOVA|||||15.7|-5.3|0.3328
71135412|NCT03201419|141772601|SUPERIORITY||Mean Difference|15.5||||0.0255|TWO_SIDED|95.0|1.9|29.2||Threshold for significance at 0.05 level.|ANCOVA|||||29.2|1.9|0.0255
71135413|NCT03201419|141772601|SUPERIORITY||Mean Difference|2.5||||0.7296|TWO_SIDED|95.0|-11.7|16.7||Threshold for significance at 0.05 level.|ANCOVA|||||16.7|-11.7|0.7296
71135414|NCT03201419|141772601|SUPERIORITY||Mean Difference|-6.7||||0.4586|TWO_SIDED|95.0|-24.5|11.1||Threshold for significance at 0.05 level.|ANCOVA|||||11.1|-24.5|0.4586
71135415|NCT03201419|141772601|SUPERIORITY||Mean Difference|11.2||||0.2327|TWO_SIDED|95.0|-7.2|29.5||Threshold for significance at 0.05 level.|ANCOVA|||||29.5|-7.2|0.2327
71135416|NCT03201419|141772601|SUPERIORITY||Mean Difference|-0.6||||0.924|TWO_SIDED|95.0|-13.3|12.1||Threshold for significance at 0.05 level.|ANCOVA|||||12.1|-13.3|0.9240
71135417|NCT03201419|141772602|SUPERIORITY||Mean Difference|0.3||||0.9499|TWO_SIDED|95.0|-7.9|8.5||Threshold for significance at 0.05 level.|ANCOVA|||||8.5|-7.9|0.9499
71135418|NCT03201419|141772602|SUPERIORITY||Mean Difference|5.8||||0.2842|TWO_SIDED|95.0|-4.8|16.4||Threshold for significance at 0.05 level.|ANCOVA|||||16.4|-4.8|0.2842
71135419|NCT03201419|141772602|SUPERIORITY||Mean Difference|-5.7||||0.31|TWO_SIDED|95.0|-16.8|5.4||Threshold for significance at 0.05 level.|ANCOVA|||||5.4|-16.8|0.3100
71135420|NCT03201419|141772602|SUPERIORITY||Mean Difference|-10.1||||0.1499|TWO_SIDED|95.0|-23.9|3.7||Threshold for significance at 0.05 level.|ANCOVA|||||3.7|-23.9|0.1499
71135421|NCT03201419|141772602|SUPERIORITY||Mean Difference|-8.2||||0.2571|TWO_SIDED|95.0|-22.5|6.0||Threshold for significance at 0.05 level.|ANCOVA|||||6.0|-22.5|0.2571
71135422|NCT03201419|141772602|SUPERIORITY||Mean Difference|-1.5||||0.7629|TWO_SIDED|95.0|-11.4|8.3||Threshold for significance at 0.05 level.|ANCOVA|||||8.3|-11.4|0.7629
71135423|NCT03201419|141772603|SUPERIORITY||Mean Difference|2.48||||0.4846|TWO_SIDED|95.0|-4.5|9.46||Threshold for significance at 0.05 level.|MMRM|||||9.46|-4.50|0.4846
71135424|NCT03201419|141772603|SUPERIORITY||Mean Difference|-16.93||||0.0004|TWO_SIDED|95.0|-26.26|-7.6||Threshold for significance at 0.05 level.|MMRM|||||-7.60|-26.26|0.0004
71135425|NCT03201419|141772603|SUPERIORITY||Mean Difference|-2.05||||0.6685|TWO_SIDED|95.0|-11.47|7.37||Threshold for significance at 0.05 level.|MMRM|||||7.37|-11.47|0.6685
71135426|NCT03201419|141772603|SUPERIORITY||Mean Difference|1.69||||0.7772|TWO_SIDED|95.0|-10.07|13.46||Threshold for significance at 0.05 level.|MMRM|||||13.46|-10.07|0.7772
70948002|NCT02706847|141396905|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|28.0|||<|0.001|TWO_SIDED|95.0|17.8|38.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||38.1|17.8|<0.001
70948003|NCT02706847|141396906|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|29.1|||<|0.001|TWO_SIDED|95.0|19.9|38.3||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||38.3|19.9|<0.001
71135427|NCT03201419|141772603|SUPERIORITY||Mean Difference|10.67||||0.0895|TWO_SIDED|95.0|-1.66|23.0||Threshold for significance at 0.05 level.|MMRM|||||23.00|-1.66|0.0895
71135428|NCT03201419|141772603|SUPERIORITY||Mean Difference|1.2||||0.782|TWO_SIDED|95.0|-7.34|9.74|||MMRM|||||9.74|-7.34|0.7820
71135429|NCT03201419|141772604|SUPERIORITY||Mean Difference|-0.41||||0.9175|TWO_SIDED|95.0|-8.25|7.42||Threshold for significance at 0.05 level.|MMRM|||||7.42|-8.25|0.9175
71135430|NCT03201419|141772604|SUPERIORITY||Mean Difference|-4.32||||0.4098|TWO_SIDED|95.0|-14.62|5.98||Threshold for significance at 0.05 level.|MMRM|||||5.98|-14.62|0.4098
71135431|NCT03201419|141772604|SUPERIORITY||Mean Difference|2.41||||0.6566|TWO_SIDED|95.0|-8.25|13.06||Threshold for significance at 0.05 level.|MMRM|||||13.06|-8.25|0.6566
71135432|NCT03201419|141772604|SUPERIORITY||Mean Difference|3.39||||0.6144|TWO_SIDED|95.0|-9.85|16.63||Threshold for significance at 0.05 level.|MMRM|||||16.63|-9.85|0.6144
71135433|NCT03201419|141772604|SUPERIORITY||Mean Difference|3.8||||0.5798|TWO_SIDED|95.0|-9.71|17.31||Threshold for significance at 0.05 level.|MMRM|||||17.31|-9.71|0.5798
71135434|NCT03201419|141772604|SUPERIORITY||Mean Difference|0.35||||0.9417|TWO_SIDED|95.0|-9.17|9.88||Threshold for significance at 0.05 level.|MMRM|||||9.88|-9.17|0.9417
71135435|NCT03201419|141772605|SUPERIORITY||Mean Difference|-2.81||||0.5148|TWO_SIDED|95.0|-11.31|5.68||Threshold for significance at 0.05 level.|MMRM|||||5.68|-11.31|0.5148
71135436|NCT03201419|141772605|SUPERIORITY||Mean Difference|-9.65||||0.0879|TWO_SIDED|95.0|-20.75|1.44||Threshold for significance at 0.05 level.|MMRM|||||1.44|-20.75|0.0879
71135437|NCT03201419|141772605|SUPERIORITY||Mean Difference|3.61||||0.5335|TWO_SIDED|95.0|-7.79|15.0||Threshold for significance at 0.05 level.|MMRM|||||15.00|-7.79|0.5335
71135438|NCT03201419|141772605|SUPERIORITY||Mean Difference|6.29||||0.3787|TWO_SIDED|95.0|-7.76|20.34||Threshold for significance at 0.05 level.|MMRM|||||20.34|-7.76|0.3787
71135439|NCT03201419|141772605|SUPERIORITY||Mean Difference|1.48||||0.8448|TWO_SIDED|95.0|-13.41|16.38||Threshold for significance at 0.05 level.|MMRM|||||16.38|-13.41|0.8448
71135440|NCT03201419|141772605|SUPERIORITY||Mean Difference|4.62||||0.3751|TWO_SIDED|95.0|-5.63|14.87||Threshold for significance at 0.05 level.|MMRM|||||14.87|-5.63|0.3751
71135441|NCT03201419|141772606|SUPERIORITY||Mean Difference|-0.43||||0.9245|TWO_SIDED|95.0|-9.43|8.57||Threshold for significance at 0.05 level.|MMRM|||||8.57|-9.43|0.9245
71135442|NCT03201419|141772606|SUPERIORITY||Mean Difference|-6.72||||0.2657|TWO_SIDED|95.0|-18.59|5.15||Threshold for significance at 0.05 level.|MMRM|||||5.15|-18.59|0.2657
71135443|NCT03201419|141772606|SUPERIORITY||Mean Difference|9.2||||0.1383|TWO_SIDED|95.0|-2.99|21.38||Threshold for significance at 0.05 level.|MMRM|||||21.38|-2.99|0.1383
71135444|NCT03201419|141772606|SUPERIORITY||Mean Difference|14.72||||0.0523|TWO_SIDED|95.0|-0.15|29.59||Threshold for significance at 0.05 level.|MMRM|||||29.59|-0.15|0.0523
71135445|NCT03201419|141772606|SUPERIORITY||Mean Difference|1.14||||0.8855|TWO_SIDED|95.0|-14.47|16.75||Threshold for significance at 0.05 level.|MMRM|||||16.75|-14.47|0.8855
71135446|NCT03201419|141772606|SUPERIORITY||Mean Difference|2.91||||0.5972|TWO_SIDED|95.0|-7.91|13.72||Threshold for significance at 0.05 level.|MMRM|||||13.72|-7.91|0.5972
71135447|NCT03201419|141772607|SUPERIORITY||Mean Difference|-0.54|||||TWO_SIDED|95.0|-6.09|2.28||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||2.28|-6.09|
71135448|NCT03201419|141772607|SUPERIORITY||Mean Difference|-0.28|||||TWO_SIDED|95.0|-4.3|0.75||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.75|-4.30|
71135449|NCT03201419|141772607|SUPERIORITY||Mean Difference|-0.15|||||TWO_SIDED|95.0|-2.44|0.33||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.33|-2.44|
71135450|NCT03201419|141772607|SUPERIORITY||Mean Difference|-0.04|||||TWO_SIDED|95.0|-0.92|0.07||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.07|-0.92|
71135451|NCT03201419|141772607|SUPERIORITY||Mean Difference|-0.02|||||TWO_SIDED|95.0|-0.48|0.02||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.02|-0.48|
71135452|NCT03201419|141772607|SUPERIORITY||Mean Difference|0.0|||||TWO_SIDED|95.0|-0.15|0.0||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.00|-0.15|
71135453|NCT03201419|141772608|SUPERIORITY||Mean Difference|-0.27||||0.055|TWO_SIDED|95.0|-0.545|0.006||Threshold for significance at 0.05 level.|MMRM|||||0.006|-0.545|0.0550
71135454|NCT03201419|141772608|SUPERIORITY||Mean Difference|-0.7||||0.0002|TWO_SIDED|95.0|-1.066|-0.335||Threshold for significance at 0.05 level.|MMRM|||||-0.335|-1.066|0.0002
71135455|NCT03201419|141772608|SUPERIORITY||Mean Difference|-0.037||||0.844|TWO_SIDED|95.0|-0.404|0.33||Threshold for significance at 0.05 level.|MMRM|||||0.330|-0.404|0.8440
71135456|NCT03201419|141772608|SUPERIORITY||Mean Difference|0.041||||0.861|TWO_SIDED|95.0|-0.417|0.498||Threshold for significance at 0.05 level.|MMRM|||||0.498|-0.417|0.8610
71135457|NCT03201419|141772608|SUPERIORITY||Mean Difference|0.036||||0.8871|TWO_SIDED|95.0|-0.46|0.532||Threshold for significance at 0.05 level.|MMRM|||||0.532|-0.460|0.8871
71135458|NCT03201419|141772608|SUPERIORITY||Mean Difference|0.013||||0.9396|TWO_SIDED|95.0|-0.313|0.338||Threshold for significance at 0.05 level.|MMRM|||||0.338|-0.313|0.9396
71135459|NCT03201419|141772609|SUPERIORITY||Mean Difference|-0.475||||0.005|TWO_SIDED|95.0|-0.806|-0.145||Threshold for significance at 0.05 level.|MMRM|||||-0.145|-0.806|0.0050
71135460|NCT03201419|141772609|SUPERIORITY||Mean Difference|-0.405||||0.0665|TWO_SIDED|95.0|-0.837|0.028||Threshold for significance at 0.05 level.|MMRM|||||0.028|-0.837|0.0665
71135461|NCT03201419|141772609|SUPERIORITY||Mean Difference|-0.149||||0.5245|TWO_SIDED|95.0|-0.608|0.31||Threshold for significance at 0.05 level.|MMRM|||||0.310|-0.608|0.5245
71135462|NCT03201419|141772609|SUPERIORITY||Mean Difference|-0.075||||0.7947|TWO_SIDED|95.0|-0.642|0.492||Threshold for significance at 0.05 level.|MMRM|||||0.492|-0.642|0.7947
71135463|NCT03201419|141772609|SUPERIORITY||Mean Difference|-0.211||||0.4625|TWO_SIDED|95.0|-0.777|0.355||Threshold for significance at 0.05 level.|MMRM|||||0.355|-0.777|0.4625
71135464|NCT03201419|141772609|SUPERIORITY||Mean Difference|-0.014||||0.9465|TWO_SIDED|95.0|-0.412|0.385||Threshold for significance at 0.05 level.|MMRM|||||0.385|-0.412|0.9465
71135465|NCT03201419|141772610|SUPERIORITY||Mean Difference|-0.73|||<|0.0001|TWO_SIDED|95.0|-1.078|-0.383||Threshold for significance at 0.05 level.|MMRM|||||-0.383|-1.078|<0.0001
71135466|NCT03201419|141772610|SUPERIORITY||Mean Difference|-0.686||||0.003|TWO_SIDED|95.0|-1.137|-0.236||Threshold for significance at 0.05 level.|MMRM|||||-0.236|-1.137|0.0030
71135467|NCT03201419|141772610|SUPERIORITY||Mean Difference|-0.045||||0.852|TWO_SIDED|95.0|-0.517|0.427||Threshold for significance at 0.05 level.|MMRM|||||0.427|-0.517|0.8520
71135468|NCT03201419|141772610|SUPERIORITY||Mean Difference|-0.287||||0.3205|TWO_SIDED|95.0|-0.856|0.281||Threshold for significance at 0.05 level.|MMRM|||||0.281|-0.856|0.3205
71135469|NCT03201419|141772610|SUPERIORITY||Mean Difference|-0.418||||0.1769|TWO_SIDED|95.0|-1.026|0.19||Threshold for significance at 0.05 level.|MMRM|||||0.190|-1.026|0.1769
71135470|NCT03201419|141772610|SUPERIORITY||Mean Difference|-0.3||||0.1584|TWO_SIDED|95.0|-0.717|0.118||Threshold for significance at 0.05 level.|MMRM|||||0.118|-0.717|0.1584
71135471|NCT03201419|141772611|SUPERIORITY||Mean Difference|-0.822|||<|0.0001|TWO_SIDED|95.0|-1.22|-0.424||Threshold for significance at 0.05 level.|MMRM|||||-0.424|-1.220|<0.0001
71135472|NCT03201419|141772611|SUPERIORITY||Mean Difference|-0.818||||0.0019|TWO_SIDED|95.0|-1.331|-0.306||Threshold for significance at 0.05 level.|MMRM|||||-0.306|-1.331|0.0019
71135473|NCT03201419|141772611|SUPERIORITY||Mean Difference|0.167||||0.551|TWO_SIDED|95.0|-0.383|0.716||Threshold for significance at 0.05 level.|MMRM|||||0.716|-0.383|0.5510
71135474|NCT03201419|141772611|SUPERIORITY||Mean Difference|-0.038||||0.9086|TWO_SIDED|95.0|-0.685|0.61||Threshold for significance at 0.05 level.|MMRM|||||0.610|-0.685|0.9086
71135475|NCT03201419|141772611|SUPERIORITY||Mean Difference|-0.812||||0.0185|TWO_SIDED|95.0|-1.486|-0.138||Threshold for significance at 0.05 level.|MMRM|||||-0.138|-1.486|0.0185
71135476|NCT03201419|141772611|SUPERIORITY||Mean Difference|-0.106||||0.6537|TWO_SIDED|95.0|-0.569|0.357||Threshold for significance at 0.05 level.|MMRM|||||0.357|-0.569|0.6537
71135477|NCT03201419|141772612|SUPERIORITY||Least Square Mean Difference|-0.146||||0.235|TWO_SIDED|95.0|-0.388|0.096||Threshold for significance at 0.05 level.|MMRM|||||0.096|-0.388|0.2350
71135478|NCT03201419|141772612|SUPERIORITY||Least Square Mean Difference|-0.377||||0.0215|TWO_SIDED|95.0|-0.699|-0.056||Threshold for significance at 0.05 level.|MMRM|||||-0.056|-0.699|0.0215
71135479|NCT03201419|141772612|SUPERIORITY||Least Square Mean Difference|-0.218||||0.1818|TWO_SIDED|95.0|-0.54|0.103||Threshold for significance at 0.05 level.|MMRM|||||0.103|-0.540|0.1818
71135480|NCT03201419|141772612|SUPERIORITY||Least Square Mean Difference|-0.05||||0.8063|TWO_SIDED|95.0|-0.45|0.35||Threshold for significance at 0.05 level.|MMRM|||||0.350|-0.450|0.8063
71135481|NCT03201419|141772612|SUPERIORITY||Least Square Mean Difference|0.176||||0.4414|TWO_SIDED|95.0|-0.274|0.627||Threshold for significance at 0.05 level.|MMRM|||||0.627|-0.274|0.4414
71135482|NCT03201419|141772612|SUPERIORITY||Least Square Mean Difference|-0.126||||0.4179|TWO_SIDED|95.0|-0.432|0.18||Threshold for significance at 0.05 level.|MMRM|||||0.180|-0.432|0.4179
71135483|NCT03201419|141772613|SUPERIORITY||Least Square Mean Difference|0.061||||0.6042|TWO_SIDED|95.0|-0.17|0.292||Threshold for significance at 0.05 level.|MMRM|||||0.292|-0.170|0.6042
71135484|NCT03201419|141772613|SUPERIORITY||Least Square Mean Difference|-0.127||||0.4114|TWO_SIDED|95.0|-0.432|0.177||Threshold for significance at 0.05 level.|MMRM|||||0.177|-0.432|0.4114
70948004|NCT02706847|141396906|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|28.2|||<|0.001|TWO_SIDED|95.0|19.0|37.4||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||37.4|19.0|<0.001
70948005|NCT02706847|141396907|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-1.29|||<|0.001|TWO_SIDED|95.0|-1.57|-1.01||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|Analysis of covariance (ANCOVA) model with treatment, prior biological DMARD use (stratum 1 vs stratum 2) and baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-1.01|-1.57|<0.001
70948006|NCT02706847|141396907|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-1.28|||<|0.001|TWO_SIDED|95.0|-1.56|-0.99||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use (stratum 1 vs stratum 2) and baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.99|-1.56|<0.001
70948007|NCT02706847|141396908|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-0.22|||<|0.001|TWO_SIDED|95.0|-0.34|-0.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use (stratum 1 vs stratum 2) and baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.10|-0.34|<0.001
70948008|NCT02706847|141396908|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-0.25|||<|0.001|TWO_SIDED|95.0|-0.38|-0.13||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use (stratum 1 vs stratum 2) and baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.13|-0.38|<0.001
70948009|NCT02706847|141396909|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean DIfference|3.44|||<|0.001|TWO_SIDED|95.0|1.72|5.15||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||5.15|1.72|<0.001
70948010|NCT02706847|141396909|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|4.63|||<|0.001|TWO_SIDED|95.0|2.89|6.36||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||6.36|2.89|<0.001
71135485|NCT03201419|141772613|SUPERIORITY||Least Square Mean Difference|0.099||||0.5394|TWO_SIDED|95.0|-0.219|0.418||Threshold for significance at 0.05 level.|MMRM|||||0.418|-0.219|0.5394
70948011|NCT02706847|141396910|SUPERIORITY||Response Rate Difference|22.3|||<|0.001|TWO_SIDED|95.0|13.6|31.1||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||31.1|13.6|<0.001
71135486|NCT03201419|141772613|SUPERIORITY||Least Square Mean Difference|0.149||||0.459|TWO_SIDED|95.0|-0.246|0.544||Threshold for significance at 0.05 level.|MMRM|||||0.544|-0.246|0.4590
71135487|NCT03201419|141772613|SUPERIORITY||Least Square Mean Difference|0.242||||0.2397|TWO_SIDED|95.0|-0.163|0.647||Threshold for significance at 0.05 level.|MMRM|||||0.647|-0.163|0.2397
71135488|NCT03201419|141772613|SUPERIORITY||Least Square Mean Difference|-0.039||||0.7954|TWO_SIDED|95.0|-0.332|0.254||Threshold for significance at 0.05 level.|MMRM|||||0.254|-0.332|0.7954
71135489|NCT03201419|141772614|SUPERIORITY||Least Square Mean Difference|-0.332||||0.0077|TWO_SIDED|95.0|-0.576|-0.089||Threshold for significance at 0.05 level.|MMRM|||||-0.089|-0.576|0.0077
71135490|NCT03201419|141772614|SUPERIORITY||Least Square Mean Difference|-0.61||||0.0002|TWO_SIDED|95.0|-0.927|-0.293||Threshold for significance at 0.05 level.|MMRM|||||-0.293|-0.927|0.0002
71135491|NCT03201419|141772614|SUPERIORITY||Least Square Mean Difference|-0.026||||0.8778|TWO_SIDED|95.0|-0.352|0.301||Threshold for significance at 0.05 level.|MMRM|||||0.301|-0.352|0.8778
71135492|NCT03201419|141772614|SUPERIORITY||Least Square Mean Difference|0.157||||0.4309|TWO_SIDED|95.0|-0.235|0.549||Threshold for significance at 0.05 level.|MMRM|||||0.549|-0.235|0.4309
71135493|NCT03201419|141772614|SUPERIORITY||Least Square Mean Difference|-0.017||||0.9392|TWO_SIDED|95.0|-0.444|0.411||Threshold for significance at 0.05 level.|MMRM|||||0.411|-0.444|0.9392
71135494|NCT03201419|141772614|SUPERIORITY||Least Square Mean Difference|-0.213||||0.1734|TWO_SIDED|95.0|-0.521|0.094||Threshold for significance at 0.05 level.|MMRM|||||0.094|-0.521|0.1734
71135495|NCT03201419|141772615|SUPERIORITY||Least Square Mean Difference|-0.328||||0.0133|TWO_SIDED|95.0|-0.587|-0.069||Threshold for significance at 0.05 level.|MMRM|||||-0.069|-0.587|0.0133
71135496|NCT03201419|141772615|SUPERIORITY||Least Square Mean Difference|-0.484||||0.0048|TWO_SIDED|95.0|-0.819|-0.15||Threshold for significance at 0.05 level.|MMRM|||||-0.150|-0.819|0.0048
71135497|NCT03201419|141772615|SUPERIORITY||Least Square Mean Difference|-0.04||||0.8223|TWO_SIDED|95.0|-0.395|0.314||Threshold for significance at 0.05 level.|MMRM|||||0.314|-0.395|0.8223
71135498|NCT03201419|141772615|SUPERIORITY||Least Square Mean Difference|0.215||||0.3083|TWO_SIDED|95.0|-0.2|0.63||Threshold for significance at 0.05 level.|MMRM|||||0.630|-0.200|0.3083
71135499|NCT03201419|141772615|SUPERIORITY||Least Square Mean Difference|-0.315||||0.1556|TWO_SIDED|95.0|-0.75|0.121||Threshold for significance at 0.05 level.|MMRM|||||0.121|-0.750|0.1556
70862850|NCT01920555|141212622|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.54|TWO_SIDED|95.0|-1.33|0.1||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.10|-1.33|0.54
70862851|NCT01920555|141212623|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.74|TWO_SIDED|95.0|-0.79|0.08||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.08|-0.79|0.74
70862852|NCT01920555|141212623|SUPERIORITY||Mean Difference (Final Values)|0.04||||1|TWO_SIDED|95.0|-0.37|0.45||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.45|-0.37|1.00
70862853|NCT01920555|141212623|SUPERIORITY||Mean Difference (Final Values)|-0.61||||0.02|TWO_SIDED|95.0|-1.01|-0.21||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.21|-1.01|0.02
70862854|NCT01920555|141212623|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.8|TWO_SIDED|95.0|-0.72|0.1||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.10|-0.72|0.80
70862855|NCT01920555|141212623|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.88|TWO_SIDED|95.0|-0.83|0.18||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.18|-0.83|0.88
70862856|NCT01920555|141212623|SUPERIORITY||Mean Difference (Final Values)|-0.05||||1|TWO_SIDED|95.0|-0.53|0.44||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.44|-0.53|1.00
70948012|NCT02706847|141396910|SUPERIORITY||Response Rate Difference|23.9|||<|0.001|TWO_SIDED|95.0|15.1|32.7||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||32.7|15.1|<0.001
70948013|NCT02706847|141396911|SUPERIORITY||Response Rate Difference|5.1||||0.11|TWO_SIDED|95.0|-1.1|11.2||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||11.2|-1.1|0.110
70862857|NCT01920555|141212623|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.88|TWO_SIDED|95.0|-0.79|0.15||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.15|-0.79|0.88
70948014|NCT02706847|141396911|SUPERIORITY||Response Rate Difference|16.5|||<|0.001|TWO_SIDED|95.0|9.1|23.9||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||23.9|9.1|<0.001
70948015|NCT02706847|141396912|SUPERIORITY||Response Rate Difference|16.8|||<|0.001|TWO_SIDED|95.0|8.5|25.1||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||25.1|8.5|<0.001
70948016|NCT02706847|141396912|SUPERIORITY||Response Rate Difference|14.2|||<|0.001|TWO_SIDED|95.0|6.1|22.3||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||22.3|6.1|<0.001
71135500|NCT03201419|141772615|SUPERIORITY||Least Square Mean Difference|-0.188||||0.2423|TWO_SIDED|95.0|-0.504|0.128||Threshold for significance at 0.05 level.|MMRM|||||0.128|-0.504|0.2423
71135501|NCT03201419|141772616|SUPERIORITY||Least Square Mean Difference|-0.079||||0.6381|TWO_SIDED|95.0|-0.409|0.251||Threshold for significance at 0.05 level.|MMRM|||||0.251|-0.409|0.6381
71135502|NCT03201419|141772616|SUPERIORITY||Least Square Mean Difference|-0.502||||0.0221|TWO_SIDED|95.0|-0.931|-0.073||Threshold for significance at 0.05 level.|MMRM|||||-0.073|-0.931|0.0221
71135503|NCT03201419|141772616|SUPERIORITY||Least Square Mean Difference|-0.177||||0.4112|TWO_SIDED|95.0|-0.602|0.247||Threshold for significance at 0.05 level.|MMRM|||||0.247|-0.602|0.4112
71135504|NCT03201419|141772616|SUPERIORITY||Least Square Mean Difference|0.112||||0.6761|TWO_SIDED|95.0|-0.416|0.64||Threshold for significance at 0.05 level.|MMRM|||||0.640|-0.416|0.6761
71135505|NCT03201419|141772616|SUPERIORITY||Least Square Mean Difference|0.224||||0.4898|TWO_SIDED|95.0|-0.414|0.861||Threshold for significance at 0.05 level.|MMRM|||||0.861|-0.414|0.4898
71135506|NCT03201419|141772616|SUPERIORITY||Least Square Mean Difference|0.194||||0.3311|TWO_SIDED|95.0|-0.198|0.585||Threshold for significance at 0.05 level.|MMRM|||||0.585|-0.198|0.3311
71135507|NCT03201419|141772617|SUPERIORITY||Least Square Mean Difference|-0.23||||0.1583|TWO_SIDED|95.0|-0.551|0.09||Threshold for significance at 0.05 level.|MMRM|||||0.090|-0.551|0.1583
71135508|NCT03201419|141772617|SUPERIORITY||Least Square Mean Difference|-0.275||||0.1884|TWO_SIDED|95.0|-0.685|0.136||Threshold for significance at 0.05 level.|MMRM|||||0.136|-0.685|0.1884
71135509|NCT03201419|141772617|SUPERIORITY||Least Square Mean Difference|-0.047||||0.8256|TWO_SIDED|95.0|-0.463|0.369||Threshold for significance at 0.05 level.|MMRM|||||0.369|-0.463|0.8256
71135510|NCT03201419|141772617|SUPERIORITY||Least Square Mean Difference|0.059||||0.8198|TWO_SIDED|95.0|-0.455|0.574||Threshold for significance at 0.05 level.|MMRM|||||0.574|-0.455|0.8198
71135511|NCT03201419|141772617|SUPERIORITY||Least Square Mean Difference|-0.431||||0.1793|TWO_SIDED|95.0|-1.061|0.199||Threshold for significance at 0.05 level.|MMRM|||||0.199|-1.061|0.1793
71135512|NCT03201419|141772617|SUPERIORITY||Least Square Mean Difference|-0.196||||0.3155|TWO_SIDED|95.0|-0.581|0.189||Threshold for significance at 0.05 level.|MMRM|||||0.189|-0.581|0.3155
71135513|NCT03201419|141772618|SUPERIORITY||Least Square Mean Difference|-0.241||||0.183|TWO_SIDED|95.0|-0.596|0.114||Threshold for significance at 0.05 level.|MMRM|||||0.114|-0.596|0.1830
71135514|NCT03201419|141772618|SUPERIORITY||Least Square Mean Difference|-0.313||||0.1618|TWO_SIDED|95.0|-0.751|0.126||Threshold for significance at 0.05 level.|MMRM|||||0.126|-0.751|0.1618
71135515|NCT03201419|141772618|SUPERIORITY||Least Square Mean Difference|-0.26||||0.2519|TWO_SIDED|95.0|-0.706|0.186||Threshold for significance at 0.05 level.|MMRM|||||0.186|-0.706|0.2519
71135516|NCT03201419|141772618|SUPERIORITY||Least Square Mean Difference|0.232||||0.4044|TWO_SIDED|95.0|-0.316|0.781||Threshold for significance at 0.05 level.|MMRM|||||0.781|-0.316|0.4044
71135517|NCT03201419|141772618|SUPERIORITY||Least Square Mean Difference|-0.28||||0.4348|TWO_SIDED|95.0|-0.986|0.426||Threshold for significance at 0.05 level.|MMRM|||||0.426|-0.986|0.4348
71135518|NCT03201419|141772618|SUPERIORITY||Least Square Mean Difference|-0.15||||0.4786|TWO_SIDED|95.0|-0.565|0.266||Threshold for significance at 0.05 level.|MMRM|||||0.266|-0.565|0.4786
71135519|NCT03201419|141772619|SUPERIORITY||Least Square Mean Difference|-0.223||||0.2412|TWO_SIDED|95.0|-0.598|0.151||Threshold for significance at 0.05 level.|MMRM|||||0.151|-0.598|0.2412
71135520|NCT03201419|141772619|SUPERIORITY||Least Square Mean Difference|-0.48||||0.0501|TWO_SIDED|95.0|-0.959|0.0||Threshold for significance at 0.05 level.|MMRM|||||0.000|-0.959|0.0501
71135521|NCT03201419|141772619|SUPERIORITY||Least Square Mean Difference|0.069||||0.7788|TWO_SIDED|95.0|-0.417|0.556||Threshold for significance at 0.05 level.|MMRM|||||0.556|-0.417|0.7788
71135522|NCT03201419|141772619|SUPERIORITY||Least Square Mean Difference|-0.111||||0.7111|TWO_SIDED|95.0|-0.698|0.477||Threshold for significance at 0.05 level.|MMRM|||||0.477|-0.698|0.7111
71135523|NCT03201419|141772619|SUPERIORITY||Least Square Mean Difference|-0.205||||0.5816|TWO_SIDED|95.0|-0.937|0.527||Threshold for significance at 0.05 level.|MMRM|||||0.527|-0.937|0.5816
71135524|NCT03201419|141772619|SUPERIORITY||Least Square Mean Difference|-0.152||||0.4981|TWO_SIDED|95.0|-0.595|0.29||Threshold for significance at 0.05 level.|MMRM|||||0.290|-0.595|0.4981
71135525|NCT03201419|141772620|SUPERIORITY||Least Square Mean Difference|-1.313||||0.1733|TWO_SIDED|95.0|-3.207|0.582||Threshold for significance at 0.05 level.|MMRM|||||0.582|-3.207|0.1733
71135526|NCT03201419|141772620|SUPERIORITY||Least Square Mean Difference|-1.375||||0.2538|TWO_SIDED|95.0|-3.745|0.994||Threshold for significance at 0.05 level.|MMRM|||||0.994|-3.745|0.2538
71135527|NCT03201419|141772620|SUPERIORITY||Least Square Mean Difference|-0.353||||0.7782|TWO_SIDED|95.0|-2.818|2.113||Threshold for significance at 0.05 level.|MMRM|||||2.113|-2.818|0.7782
71135528|NCT03201419|141772620|SUPERIORITY||Least Square Mean Difference|-0.151||||0.9218|TWO_SIDED|95.0|-3.182|2.88||Threshold for significance at 0.05 level.|MMRM|||||2.880|-3.182|0.9218
71135529|NCT03201419|141772620|SUPERIORITY||Least Square Mean Difference|0.767||||0.6823|TWO_SIDED|95.0|-2.923|4.457||Threshold for significance at 0.05 level.|MMRM|||||4.457|-2.923|0.6823
71135530|NCT03201419|141772620|SUPERIORITY||Least Square Mean Difference|-1.095||||0.3436|TWO_SIDED|95.0|-3.369|1.179||Threshold for significance at 0.05 level.|MMRM|||||1.179|-3.369|0.3436
71135531|NCT03201419|141772621|SUPERIORITY||Least Square Mean Difference|-1.235||||0.2042|TWO_SIDED|95.0|-3.146|0.676||Threshold for significance at 0.05 level.|MMRM|||||0.676|-3.146|0.2042
71135532|NCT03201419|141772621|SUPERIORITY||Least Square Mean Difference|-1.683||||0.1591|TWO_SIDED|95.0|-4.031|0.665||Threshold for significance at 0.05 level.|MMRM|||||0.665|-4.031|0.1591
71135533|NCT03201419|141772621|SUPERIORITY||Least Square Mean Difference|-0.285||||0.8168|TWO_SIDED|95.0|-2.708|2.138||Threshold for significance at 0.05 level.|MMRM|||||2.138|-2.708|0.8168
71135534|NCT03201419|141772621|SUPERIORITY||Least Square Mean Difference|-0.551||||0.7148|TWO_SIDED|95.0|-3.517|2.416||Threshold for significance at 0.05 level.|MMRM|||||2.416|-3.517|0.7148
71135535|NCT03201419|141772621|SUPERIORITY||Least Square Mean Difference|0.701||||0.7141|TWO_SIDED|95.0|-3.066|4.468||Threshold for significance at 0.05 level.|MMRM|||||4.468|-3.066|0.7141
70862858|NCT01920555|141212623|SUPERIORITY||Mean Difference (Final Values)|-0.29||||0.88|TWO_SIDED|95.0|-0.76|0.19||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.19|-0.76|0.88
70862859|NCT01920555|141212624|SUPERIORITY||Mean Difference (Final Values)|11.18||||0.49|TWO_SIDED|95.0|-0.94|23.29||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||23.29|-0.94|0.49
71135536|NCT03201419|141772621|SUPERIORITY||Least Square Mean Difference|-0.759||||0.5041|TWO_SIDED|95.0|-2.995|1.477||Threshold for significance at 0.05 level.|MMRM|||||1.477|-2.995|0.5041
71135537|NCT03201419|141772622|SUPERIORITY||Least Square Mean Difference|-1.129||||0.2896|TWO_SIDED|95.0|-3.226|0.967||Threshold for significance at 0.05 level.|MMRM|||||0.967|-3.226|0.2896
71135538|NCT03201419|141772622|SUPERIORITY||Least Square Mean Difference|-2.652||||0.0498|TWO_SIDED|95.0|-5.301|-0.003||Threshold for significance at 0.05 level.|MMRM|||||-0.003|-5.301|0.0498
71135539|NCT03201419|141772622|SUPERIORITY||Least Square Mean Difference|0.323||||0.8159|TWO_SIDED|95.0|-2.409|3.055||Threshold for significance at 0.05 level.|MMRM|||||3.055|-2.409|0.8159
71135540|NCT03201419|141772622|SUPERIORITY||Least Square Mean Difference|0.485||||0.7719|TWO_SIDED|95.0|-2.809|3.779||Threshold for significance at 0.05 level.|MMRM|||||3.779|-2.809|0.7719
71135541|NCT03201419|141772622|SUPERIORITY||Least Square Mean Difference|1.676||||0.4193|TWO_SIDED|95.0|-2.407|5.76||Threshold for significance at 0.05 level.|MMRM|||||5.760|-2.407|0.4193
71135542|NCT03201419|141772622|SUPERIORITY||Least Square Mean Difference|-1.23||||0.3333|TWO_SIDED|95.0|-3.73|1.27||Threshold for significance at 0.05 level.|MMRM|||||1.270|-3.730|0.3333
71135543|NCT03201419|141772623|SUPERIORITY||Mean Difference|41.8||||0.0853|TWO_SIDED|95.0|-5.9|89.6||Threshold for significance at 0.05 level.|MMRM|||||89.6|-5.9|0.0853
71135544|NCT03201419|141772623|SUPERIORITY||Mean Difference|105.9||||0.001|TWO_SIDED|95.0|43.4|168.4||Threshold for significance at 0.05 level.|MMRM|||||168.4|43.4|0.0010
71135545|NCT03201419|141772623|SUPERIORITY||Mean Difference|24.9||||0.4418|TWO_SIDED|95.0|-38.8|88.6||Threshold for significance at 0.05 level.|MMRM|||||88.6|-38.8|0.4418
71135546|NCT03201419|141772623|SUPERIORITY||Mean Difference|10.7||||0.7902|TWO_SIDED|95.0|-68.2|89.6||Threshold for significance at 0.05 level.|MMRM|||||89.6|-68.2|0.7902
71135547|NCT03201419|141772623|SUPERIORITY||Mean Difference|1.8||||0.9664|TWO_SIDED|95.0|-84.2|87.9||Threshold for significance at 0.05 level.|MMRM|||||87.9|-84.2|0.9664
71135548|NCT03201419|141772623|SUPERIORITY||Mean Difference|-29.8||||0.2977|TWO_SIDED|95.0|-85.9|26.4||Threshold for significance at 0.05 level.|MMRM|||||26.4|-85.9|0.2977
71135549|NCT03201419|141772624|SUPERIORITY||Mean Difference|14.3||||0.5523|TWO_SIDED|95.0|-33.0|61.5||Threshold for significance at 0.05 level.|MMRM|||||61.5|-33.0|0.5523
71135550|NCT03201419|141772624|SUPERIORITY||Mean Difference|60.8||||0.0556|TWO_SIDED|95.0|-1.5|123.0||Threshold for significance at 0.05 level.|MMRM|||||123.0|-1.5|0.0556
71135551|NCT03201419|141772624|SUPERIORITY||Mean Difference|-17.9||||0.5837|TWO_SIDED|95.0|-82.0|46.3||Threshold for significance at 0.05 level.|MMRM|||||46.3|-82.0|0.5837
71135552|NCT03201419|141772624|SUPERIORITY||Mean Difference|-60.7||||0.1363|TWO_SIDED|95.0|-140.7|19.3||Threshold for significance at 0.05 level.|MMRM|||||19.3|-140.7|0.1363
71135553|NCT03201419|141772624|SUPERIORITY||Mean Difference|-28.2||||0.4938|TWO_SIDED|95.0|-109.1|52.8||Threshold for significance at 0.05 level.|MMRM|||||52.8|-109.1|0.4938
71135554|NCT03201419|141772624|SUPERIORITY||Mean Difference|-54.7||||0.0535|TWO_SIDED|95.0|-110.2|0.8||Threshold for significance at 0.05 level.|MMRM|||||0.8|-110.2|0.0535
71135555|NCT03201419|141772625|SUPERIORITY||Mean Difference|-0.7||||0.9829|TWO_SIDED|95.0|-62.2|60.9||Threshold for significance at 0.05 level.|MMRM|||||60.9|-62.2|0.9829
71135556|NCT03201419|141772625|SUPERIORITY||Mean Difference|64.4||||0.1038|TWO_SIDED|95.0|-13.3|142.1||Threshold for significance at 0.05 level.|MMRM|||||142.1|-13.3|0.1038
71135557|NCT03201419|141772625|SUPERIORITY||Mean Difference|29.2||||0.4764|TWO_SIDED|95.0|-51.4|109.8||Threshold for significance at 0.05 level.|MMRM|||||109.8|-51.4|0.4764
71135558|NCT03201419|141772625|SUPERIORITY||Mean Difference|-24.2||||0.6204|TWO_SIDED|95.0|-120.5|72.0||Threshold for significance at 0.05 level.|MMRM|||||72.0|-120.5|0.6204
71135559|NCT03201419|141772625|SUPERIORITY||Mean Difference|2.2||||0.966|TWO_SIDED|95.0|-100.1|104.6||Threshold for significance at 0.05 level.|MMRM|||||104.6|-100.1|0.9660
71135560|NCT03201419|141772625|SUPERIORITY||Mean Difference|3.3||||0.9275|TWO_SIDED|95.0|-67.4|73.9||Threshold for significance at 0.05 level.|MMRM|||||73.9|-67.4|0.9275
71135561|NCT03201419|141772626|SUPERIORITY||Mean Difference|15.7||||0.5964|TWO_SIDED|95.0|-42.7|74.2||Threshold for significance at 0.05 level.|MMRM|||||74.2|-42.7|0.5964
71135562|NCT03201419|141772626|SUPERIORITY||Mean Difference|-2.8||||0.9418|TWO_SIDED|95.0|-78.5|72.9||Threshold for significance at 0.05 level.|MMRM|||||72.9|-78.5|0.9418
70948017|NCT01174264|141396924|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.75||||0.003|TWO_SIDED|90.0|1.3|2.34|||t-test, 2 sided|Performed on log-transformed data.||||2.34|1.30|0.003
70948018|NCT01174264|141396924|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.08||||0.65|TWO_SIDED|90.0|0.81|1.44||Performed on log-transformed data.|t-test, 2 sided|||||1.44|0.81|0.65
70948019|NCT01174264|141396925|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.74||||0.008|TWO_SIDED|90.0|1.25|2.42|||t-test, 2 sided|Performed on log-transformed data.||||2.42|1.25|0.008
70948020|NCT01174264|141396925|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.12||||0.51|TWO_SIDED|90.0|0.84|1.49|||t-test, 2 sided|Performed on log-transformed data.||||1.49|0.84|0.51
71135563|NCT03201419|141772626|SUPERIORITY||Mean Difference|18.0||||0.6452|TWO_SIDED|95.0|-58.8|94.7||Threshold for significance at 0.05 level.|MMRM|||||94.7|-58.8|0.6452
71135564|NCT03201419|141772626|SUPERIORITY||Mean Difference|-51.3||||0.2565|TWO_SIDED|95.0|-140.2|37.6||Threshold for significance at 0.05 level.|MMRM|||||37.6|-140.2|0.2565
71135565|NCT03201419|141772626|OTHER||Mean Difference|-21.6||||0.6605|TWO_SIDED|95.0|-118.6|75.4||Threshold for significance at 0.05 level.|MMRM|||||75.4|-118.6|0.6605
71135566|NCT03201419|141772626|SUPERIORITY||Mean Difference|3.4||||0.9191|TWO_SIDED|95.0|-62.6|69.4||Threshold for significance at 0.05 level.|MMRM|||||69.4|-62.6|0.9191
71135567|NCT03201419|141772627|SUPERIORITY||Mean Difference|17.52|||||TWO_SIDED|95.0|-6.19|62.09||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||62.09|-6.19|
71135568|NCT03201419|141772627|SUPERIORITY||Mean Difference|12.78|||||TWO_SIDED|95.0|-0.73|55.89||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||55.89|-0.73|
71135569|NCT03201419|141772627|SUPERIORITY||Mean Difference|8.5|||||TWO_SIDED|95.0|-0.14|47.28||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||47.28|-0.14|
70948021|NCT01174264|141396927|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.83
70948022|NCT01174264|141396927|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.57
71135570|NCT03201419|141772627|SUPERIORITY||Mean Difference|3.29|||||TWO_SIDED|95.0|-0.01|28.07||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||28.07|-0.01|
70948023|NCT01174264|141396928|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0001
70948024|NCT01174264|141396928|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0001
70948025|NCT01174264|141396929|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.16||||0.17|TWO_SIDED|90.0|0.97|1.38|||t-test, 2 sided|Performed on log-transformed data.||||1.38|0.97|0.17
70948026|NCT01174264|141396930|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.13||||0.25|TWO_SIDED|90.0|0.95|1.35|||t-test, 2 sided|Performed on log-transformed data.||||1.35|0.95|0.25
70948027|NCT01174264|141396931|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.22||||0.096|TWO_SIDED|90.0|1.0|1.48||Performed on log-transformed data.|t-test, 2 sided|||||1.48|1.00|0.096
70948028|NCT01174264|141396932|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.27
71135571|NCT03201419|141772627|SUPERIORITY||Mean Difference|1.74|||||TWO_SIDED|95.0|0.0|17.9||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||17.90|-0.00|
71135572|NCT03201419|141772627|SUPERIORITY||Mean Difference|0.68|||||TWO_SIDED|95.0|0.0|7.55||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||7.55|-0.00|
71135573|NCT03201419|141772628|SUPERIORITY||Mean Difference|-0.173||||0.0196|TWO_SIDED|95.0|-0.318|-0.028||Threshold for significance at 0.05 level.|MMRM|||||-0.028|-0.318|0.0196
71135574|NCT03201419|141772628|SUPERIORITY||Mean Difference|-0.233||||0.0167|TWO_SIDED|95.0|-0.423|-0.043||Threshold for significance at 0.05 level.|MMRM|||||-0.043|-0.423|0.0167
71135575|NCT03201419|141772628|SUPERIORITY||Mean Difference|-0.208||||0.0352|TWO_SIDED|95.0|-0.401|-0.015||Threshold for significance at 0.05 level.|MMRM|||||-0.015|-0.401|0.0352
71135576|NCT03201419|141772628|SUPERIORITY||Mean Difference|-0.057||||0.6402|TWO_SIDED|95.0|-0.295|0.182||Threshold for significance at 0.05 level.|MMRM|||||0.182|-0.295|0.6402
71135577|NCT03201419|141772628|SUPERIORITY||Mean Difference|-0.121||||0.3602|TWO_SIDED|95.0|-0.381|0.139||Threshold for significance at 0.05 level.|MMRM|||||0.139|-0.381|0.3602
71135578|NCT03201419|141772628|SUPERIORITY||Mean Difference|0.074||||0.4018|TWO_SIDED|95.0|-0.099|0.247||Threshold for significance at 0.05 level.|MMRM|||||0.247|-0.099|0.4018
71135579|NCT03201419|141772629|SUPERIORITY||Mean Difference|-0.133||||0.1354|TWO_SIDED|95.0|-0.308|0.042||Threshold for significance at 0.05 level.|MMRM|||||0.042|-0.308|0.1354
71135580|NCT03201419|141772629|SUPERIORITY||Mean Difference|-0.091||||0.4238|TWO_SIDED|95.0|-0.315|0.133||Threshold for significance at 0.05 level.|MMRM|||||0.133|-0.315|0.4238
71135581|NCT03201419|141772629|SUPERIORITY||Mean Difference|-0.22||||0.0574|TWO_SIDED|95.0|-0.446|0.007||Threshold for significance at 0.05 level.|MMRM|||||0.007|-0.446|0.0574
71135582|NCT03201419|141772629|SUPERIORITY||Mean Difference|0.058||||0.6579|TWO_SIDED|95.0|-0.199|0.315||Threshold for significance at 0.05 level.|MMRM|||||0.315|-0.199|0.6579
70872175|NCT01438957|141229581|SUPERIORITY|||||||0.044|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.044
70872176|NCT01438957|141229581|SUPERIORITY|||||||0.234|||||||Mantel Haenszel|Stratified by the anesthesia type||||||0.234
71135583|NCT03201419|141772629|SUPERIORITY||Mean Difference|-0.17||||0.2337|TWO_SIDED|95.0|-0.45|0.11||Threshold for significance at 0.05 level.|MMRM|||||0.110|-0.450|0.2337
71135584|NCT03201419|141772629|SUPERIORITY||Mean Difference|-0.136||||0.1639|TWO_SIDED|95.0|-0.328|0.056||Threshold for significance at 0.05 level.|MMRM|||||0.056|-0.328|0.1639
71135585|NCT03201419|141772630|SUPERIORITY||Mean Difference|-87.2||||0.047|TWO_SIDED|95.0|-173.2|-1.2|||MMRM|||||-1.2|-173.2|0.0470
71135586|NCT03201419|141772630|SUPERIORITY||Mean Difference|-130.2||||0.0237|TWO_SIDED|95.0|-242.9|-17.6|||MMRM|||||-17.6|-242.9|0.0237
71135587|NCT03201419|141772630|SUPERIORITY||Mean Difference|-110.8||||0.0569|TWO_SIDED|95.0|-224.9|3.3|||MMRM|||||3.3|-224.9|0.0569
71135588|NCT03201419|141772630|SUPERIORITY||Mean Difference|-23.9||||0.7383|TWO_SIDED|95.0|-164.8|117.0|||MMRM|||||117.0|-164.8|0.7383
71135589|NCT03201419|141772630|SUPERIORITY||Mean Difference|-71.0||||0.3626|TWO_SIDED|95.0|-224.3|82.3|||MMRM|||||82.3|-224.3|0.3626
71135590|NCT03201419|141772630|SUPERIORITY||Mean Difference|23.4||||0.6524|TWO_SIDED|95.0|-78.9|125.7|||MMRM|||||125.7|-78.9|0.6524
71135591|NCT03201419|141772631|SUPERIORITY||Mean Difference|-49.5||||0.3273|TWO_SIDED|95.0|-148.9|49.9||Threshold for significance at 0.05 level.|MMRM|||||49.9|-148.9|0.3273
71135592|NCT03201419|141772631|SUPERIORITY||Mean Difference|-74.6||||0.25|TWO_SIDED|95.0|-202.0|52.9||Threshold for significance at 0.05 level.|MMRM|||||52.9|-202.0|0.2500
71135593|NCT03201419|141772631|SUPERIORITY||Mean Difference|-93.5||||0.1537|TWO_SIDED|95.0|-222.3|35.2||Threshold for significance at 0.05 level.|MMRM|||||35.2|-222.3|0.1537
71135594|NCT03201419|141772631|SUPERIORITY||Mean Difference|33.6||||0.6515|TWO_SIDED|95.0|-113.1|180.3||Threshold for significance at 0.05 level.|MMRM|||||180.3|-113.1|0.6515
71135595|NCT03201419|141772631|SUPERIORITY||Mean Difference|-75.7||||0.3506|TWO_SIDED|95.0|-235.3|83.9||Threshold for significance at 0.05 level.|MMRM|||||83.9|-235.3|0.3506
71135596|NCT03201419|141772631|SUPERIORITY||Mean Difference|-85.4||||0.1255|TWO_SIDED|95.0|-194.8|24.1||Threshold for significance at 0.05 level.|MMRM|||||24.1|-194.8|0.1255
71135597|NCT00369577|141772658|SUPERIORITY|||||||0.088||||||p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA|||||||0.0880
71135598|NCT00369577|141772658|SUPERIORITY|||||||0.0002||||||p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA|||||||0.0002
71135599|NCT00369577|141772659|SUPERIORITY|||||||0.0583|||||||Wilcoxon (Mann-Whitney)|||||||0.0583
71135600|NCT00369577|141772659|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
71135601|NCT00369577|141772660|SUPERIORITY|||||||0.0067|||||||Wilcoxon (Mann-Whitney)|||||||0.0067
71135602|NCT00369577|141772660|SUPERIORITY|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||||||0.0003
71135603|NCT00369577|141772661|SUPERIORITY|||||||0.0076|||||||Fisher Exact|||||||0.0076
71135604|NCT00369577|141772661|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||||||0.0001
71135605|NCT02360228|141772672|OTHER|||||||0.47|||||||ANOVA|Difference from day 5 to baseline was compared between the tACS, tDCS, and sham groups using a one way ANOVA. Degrees of freedom: df=19||The null hypothesis was that there is no difference between the changes in the AHRS score from baseline to 5 days between the groups.H0: μ1=μ2=μ3 μ1: mean(difference 5 days-baseline) for tACS group (n=8) μ2: mean(difference 5 days-baseline) for tDCS group (n=7) μ3: mean(difference 5 days-baseline) for sham group (n=7)||||0.47
71135606|NCT02360228|141772674|OTHER|||||||0.37|||||||ANOVA|Difference from day 5 to baseline was compared between the tACS, tDCS, and sham using a one way ANOVA. Degrees of freedom: df=19||The null hypothesis was that there is no difference between the changes in the PANSS score from day 5 to baseline. H0: μ1=μ2=μ3 μ1: mean(difference 5 days-baseline) for tACS group (n=8) μ2: mean(difference 5 days-baseline) for tDCS group (n=7) μ3: mean(difference 5 days-baseline) for sham group (n=7)||||0.37
71135607|NCT02360228|141772675|OTHER|||||||0.11|||||||ANOVA|Difference from day 5 to baseline was compared between the tACS, tDCS, and sham groups using a one way ANOVA. Degrees of freedom: df=19||"The null hypothesis was that there is no difference between the changes in the BACS score from baseline to 5 days between the groups:~H0: μ1=μ2=μ3 μ1: mean(difference 5 days-baseline) for tACS group (n=8) μ2: mean(difference 5 days-baseline) for tDCS group (n=7) μ3: mean(difference 5 days-baseline) for sham group (n=7)"||||0.11
71135608|NCT01059318|141772681|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|76.0|||||TWO_SIDED|95.0|-45.0|196.0|||Bayesian analysis|A Bayesian posterior distribution of the treatment effect at 26 weeks was evaluated using a non-informative prior.|MILES study and current study had different study designs, so change from baseline to 26 weeks in MILES study was estimated from the publicly reported rate of change per month in order to provide a meaningful comparison based on Bayesian analysis.|"Proof of Concept was proposed as follows:~* 90% level of proof that difference in FVC change from baseline everolimus vs. Historical Placebo Control arm from MILES study \> 0 mL~* 50% level of proof that difference in FVC change from baseline everolimus vs. Historical Placebo Control arm from MILES study \>= 100 mL~Historical data from 43 patients treated with placebo from the MILES study were down weighted to an effective sample size of 18 for comparison."||196|-45|
71135609|NCT01059318|141772682|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|186.0|||||TWO_SIDED|95.0|93.0|279.0|||Bayesian analysis|A Bayesian posterior distribution of the treatment effect at 26 weeks was evaluated using a non-informative prior.|MILES study and current study had different study designs, so change from baseline to 26 weeks in MILES study was estimated from the publicly reported rate of change per month in order to provide a meaningful comparison based on Bayesian analysis.|"Proof of Concept was proposed as follows:~* 90% level of proof that difference in FEV1 change from baseline everolimus vs. Historical Placebo Control arm from MILES study \> 0 mL~* 50% level of proof that difference in FEV1 change from baseline everolimus vs. Historical Placebo Control arm from MILES study \>= 100 mL~Historical data from 43 patients treated with placebo from the MILES study were down weighted to an effective sample size of 18 for comparison."||279|93|
71135610|NCT04186871|141772695|SUPERIORITY|RESPONSE DIFFERENCE (95% CI) VS PLACEBO|Response Difference|-27.8|||||TWO_SIDED|95.0|-77.5|21.9||||||||21.9|-77.5|
70872177|NCT01438957|141229582|SUPERIORITY|||||||0.729|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.729
71135611|NCT04186871|141772695|SUPERIORITY|ODDS RATIO (95% CI) VS PLACEBO|Odds Ratio (OR)|0.32||||0.3117|TWO_SIDED|95.0|0.04|2.73|||Cochran-Mantel-Haenszel|||||2.73|0.04|0.3117
71135612|NCT04186871|141772696|SUPERIORITY|ADJUSTED MEAN DIFFERENCE VS PLACEBO|Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.8|4.9||||||||4.9|-2.8|
71135613|NCT04186871|141772696|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 24|Mean Difference (Final Values)|-8.3|||||TWO_SIDED|95.0|-11.5|-5.0||||||||-5.0|-11.5|
71135614|NCT04186871|141772696|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 24|Mean Difference (Final Values)|-7.2|||||TWO_SIDED|95.0|-9.3|-5.2||||||||-5.2|-9.3|
71135615|NCT04186871|141772697|SUPERIORITY|RESPONSE DIFFERENCE VS PLACEBO|Response Difference|16.7|||||TWO_SIDED|95.0|-31.8|65.2||||||||65.2|-31.8|
71135616|NCT04186871|141772697|SUPERIORITY|ODDS RATIO VS PLACEBO|Odds Ratio (OR)|2.0|||||TWO_SIDED|95.0|0.22|18.04||||||||18.04|0.22|
71135617|NCT04186871|141772698|SUPERIORITY|RESPONSE DIFFERENCE (95% CI) VS PLACEBO|Response Difference|-11.9|||||TWO_SIDED|95.0|-57.1|33.3||||||||33.3|-57.1|
71135618|NCT04186871|141772698|SUPERIORITY|ODDS RATIO (95% CI) VS PLACEBO|Odds Ratio (OR)|0.4||||0.593|TWO_SIDED|95.0|0.02|10.02|||Cochran-Mantel-Haenszel|||||10.02|0.02|0.5930
71135619|NCT04186871|141772699|SUPERIORITY|RESPONSE DIFFERENCE VS PLACEBO|Response Difference|-14.6|||||TWO_SIDED|95.0|-36.9|7.7||||||||7.7|-36.9|
71135620|NCT04186871|141772699|SUPERIORITY|ODDS RATIO VS PLACEBO|Odds Ratio (OR)|0.46||||0.1639|TWO_SIDED|95.0|0.15|1.39|||Chi-squared|||||1.39|0.15|0.1639
71135621|NCT04186871|141772700|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE WEEK 12|Mean Difference (Final Values)|-1.61|||||TWO_SIDED|95.0|-2.11|-1.11||||||||-1.110|-2.110|
71135622|NCT04186871|141772700|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 12|Mean Difference (Final Values)|-1.567|||||TWO_SIDED|95.0|-1.855|-1.28||||||||-1.280|-1.855|
71135623|NCT04186871|141772700|SUPERIORITY|ADJUSTED MEAN DIFFERENCE VS PLACEBO|Mean Difference (Final Values)|0.043|||||TWO_SIDED|95.0|-0.534|0.62||||||||0.620|-0.534|
71135624|NCT04186871|141772701|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 12|Mean Difference (Final Values)|-1.741|||||TWO_SIDED|95.0|-2.256|-1.226||||||||-1.226|-2.256|
71135625|NCT04186871|141772701|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 12|Mean Difference (Final Values)|-1.698|||||TWO_SIDED|95.0|-1.998|-1.399||||||||-1.399|-1.998|
71135626|NCT04186871|141772701|SUPERIORITY|ADJUSTED MEAN DIFFERENCE VS PLACEBO|Mean Difference (Final Values)|0.043|||||TWO_SIDED|95.0|-0.553|0.639||||||||0.639|-0.553|
71135627|NCT04186871|141772702|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 12|Mean Difference (Final Values)|-19.495|||||TWO_SIDED|95.0|-24.861|-14.128||||||||-14.128|-24.861|
71135628|NCT04186871|141772702|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 12|Mean Difference (Final Values)|-18.767|||||TWO_SIDED|95.0|-21.848|-15.686||||||||-15.686|-21.848|
71135629|NCT04186871|141772702|SUPERIORITY|ADJUSTED MEAN DIFFERENCE VS PLACEBO|Mean Difference (Final Values)|0.728|||||TWO_SIDED|95.0|-5.463|6.919||||||||6.919|-5.463|
71135630|NCT04186871|141772703|EQUIVALENCE|ADJUSTED MEAN AT DIFFERENCE WEEK 12|Mean Difference (Final Values)|-19.2|||||TWO_SIDED|95.0|-24.3|-14.1||||||||-14.1|-24.3|
71135631|NCT04186871|141772703|EQUIVALENCE|ADJUSTED MEAN AT DIFFERENCE WEEK 12|Mean Difference (Final Values)|-18.5|||||TWO_SIDED|95.0|-21.4|-15.5||||||||-15.5|-21.4|
71135632|NCT04186871|141772703|SUPERIORITY|ADJUSTED MEAN DIFFERENCE VS PLACEBO|Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-5.2|6.6||||||||6.6|-5.2|
71135633|NCT04186871|141772704|SUPERIORITY|RESPONSE DIFFERENCE VS PLACEBO|Response Difference|-4.1|||||TWO_SIDED|95.0|-28.1|19.9||||||||19.9|-28.1|
71135634|NCT04186871|141772704|SUPERIORITY|ODDS RATIO VS PLACEBO|Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.31|2.32||||||||2.32|0.31|
71135635|NCT04186871|141772705|SUPERIORITY|RESPONSE DIFFERENCE VS PLACEBO|Response Difference|-6.5|||||TWO_SIDED|95.0|-22.8|9.9||||||||9.9|-22.8|
71135636|NCT04186871|141772705|SUPERIORITY|ODDS RATIO VS PLACEBO|Odds Ratio (OR)|0.51|||||TWO_SIDED|95.0|0.11|2.34||||||||2.34|0.11|
71135637|NCT01604291|141772727|OTHER|||||||0.9109||||||The p-value from chi-square is the difference between SVR achieved (yes/no) and dose modifications.|Chi-squared|||Correlation between SVR 24 and Gender||||0.9109
71135638|NCT01604291|141772727|OTHER|||||||0.1163||||||A t-test was done to compare SVR participants to non-SVR.|t-test, 1 sided|||Correlation between SVR 24 and Age||||0.1163
71135639|NCT01604291|141772727|OTHER|||||||0.9269||||||A t-test was done to compare SVR participants to non-SVR.|t-test, 1 sided|||Correlation between SVR 24 and Height||||0.9269
71135640|NCT01604291|141772727|OTHER|||||||0.3376||||||A t-test was done to compare SVR participants to non-SVR.|t-test, 1 sided|||Correlation between SVR 24 and Weight||||0.3376
71135641|NCT01604291|141772727|OTHER|||||||0.4618||||||A t-test was done to compare SVR participants to non-SVR.|t-test, 1 sided|||Correlation between SVR 24 and Body mass index.||||0.4618
71135642|NCT01604291|141772740|OTHER||phi-coefficient|-0.0835||||0.0463|||||||Chi-squared|The p-value from chi-square is the difference between SVR achieved (yes/no) and dose modifications.|phi-coefficient is a measure of the degree of association between two binary variables|Correlation with dose modification for Peginterferon alfa-2a.||||0.0463
71135643|NCT01604291|141772740|OTHER||phi-coefficient|0.0666||||0.2052|||||||Chi-squared|The p-value from chi-square is the difference between SVR achieved (yes/no) and dose modifications.|phi-coefficient is a measure of the degree of association between two binary variables.|Correlation with dose modification for Ribavirin.||||0.2052
71135644|NCT01604291|141772740|OTHER||phi-coefficient|-0.1672||||0.0033|||||||Fisher Exact|The p-value from chi-square is the difference between SVR achieved (yes/no) and dose modifications.|phi-coefficient is a measure of the degree of association between two binary variables.|Correlation with dose modification for Telaprevir/boceprevir.||||0.0033
71135645|NCT01657292|141772741|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||1-sided, significance level = 0.025|Binomial test|||"All patients received both treatments and treatments were intra-individually compared.~Hypotheses tested: H0: s0 ≤0.5 and H1: s0 \>0.5 (with s0=rate of superiority of Oleogel-S10)."||||<0.0001
71135646|NCT00650845|141772752|NON_INFERIORITY_OR_EQUIVALENCE|Assuming that in both MRI groups approximately 12% of the patients would have an increase in serum creatinine of at least 25% with respect to baseline values after imaging procedures, 120 evaluable patients (2 x 60) were needed to ensure with 80% power, at 5% one-sided significance level, that the difference between the two MRI procedures was less than 15% which was the non-inferiority clinical limit of the difference established for this study.|Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-7.9|6.7||||||The clinical non-inferiority limit of (non-enhanced - Dotarem®-enhanced) was fixed at -15%. The exact 95%Confidence Interval (CI) of the difference (non-enhanced - Dotarem®-enhanced) was \[-7.9%; +6.7%\]||6.7|-7.9|
71135647|NCT00650845|141772753|SUPERIORITY_OR_OTHER|||||||0.291|TWO_SIDED|||||p-value for main effect (difference between groups) adjusted on centers.|t-test, 2 sided|||Serum creatinine level fluctuation in terms of difference between baseline and 72 ±24hours after imaging procedure values was computed for both MRI procedures and compared between the 2 groups. A linear regression model was used to model the serum creatinine changes from baseline as a function of the MRI procedure with adjustment on centers.||||0.291
71135648|NCT00650845|141772754|NON_INFERIORITY_OR_EQUIVALENCE|Assuming that in both MRI groups approximately 12% of the patients would have an increase in serum creatinine of at least 25% with respect to baseline values after imaging procedures, 120 evaluable patients (2 x 60) were needed to ensure with 80% power, at 5% one-sided significance level, that the difference between the two MRI procedures was less than 15% which was the non-inferiority clinical limit of the difference established for this study.|Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-14.1|8.9||||||The clinical non-inferiority limit of (non-enhanced - Dotarem®-enhanced) was fixed at -15%. The exact 95%CI of the difference (non-enhanced - Dotarem®-enhanced) was \[-14.1%; +8.9%\]||8.9|-14.1|
71135649|NCT00650845|141772755|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|||||p-value for main effect (difference between groups) adjusted on centers.|t-test, 2 sided|||Serum creatinine level fluctuation in terms of difference between baseline and 72 ±24hours after imaging procedure values was computed for both MRI procedures and compared between the 2 groups. A linear regression model was used to model the serum creatinine changes from baseline as a function of the MRI procedure with adjustment on centers.||||0.040
71135650|NCT00650845|141772756|SUPERIORITY_OR_OTHER|||||||0.301|TWO_SIDED|||||p-value for main effect (difference between groups) adjusted on centers.|t-test, 2 sided|||eGFR fluctuation in terms of percentage and mean difference between baseline and 72 ±24hours after imaging procedure values was computed for both MRI procedures and compared between the 2 groups. A linear regression model was used to model the relative or absolute eGFR variation from baseline as a function of the MRI procedure with adjustment on centers.||||0.301
71135651|NCT00650845|141772757|SUPERIORITY_OR_OTHER|||||||0.051|TWO_SIDED|||||p-value for main effect (difference between groups) adjusted on centers.|t-test, 2 sided|||eGFR fluctuation in terms of percentage and mean difference between baseline and 72 ±24hours after imaging procedure values was computed for both MRI procedures and compared between the 2 groups. A linear regression model was used to model the relative or absolute eGFR variation from baseline as a function of the MRI procedure with adjustment on centers.||||0.051
71135652|NCT03932760|141772758|OTHER|Mean differences at the tested timepoints between VCI and AC. Models were also examined with the covariates of medication use and pregnant/post-partum status.|Mean estimates by time|0.913|STANDARD_ERROR_OF_MEAN|1.085||0.612|TWO_SIDED|95.0|-1.228|3.055|||Mixed Models Analysis||Time was treated as a categorical variable to allow for non-linear change over time. We present group, time, and group\*time estimates and their associated SE and CIs below. AC group and baseline timepoint are the reference categories.|We used multilevel generalized mixed modeling under an intent-to-treat approach to compare the outcome measures of EPDS between group 1 (VCI) and Group 2 (AC) at 6 time points during pregnancy and postpartum controlling for screening EPDS score. We powered for the fixed effect of Intervention X Time using RMANOVA with alpha = 0.5, 6 time points, 0.3 for correlation between repeated measures, and a sample size of 192 total participants gives greater than 90% power to detect an effect size of 0.1.|"Overall test of significance for Fixed Effects. Higher EPDS scores signify worsened symptoms of depression. Time uses start of study as reference controlling for screen EPDS.~Group VCI (AC reference): F=0.260, p=0.612~Time (Baseline as reference): F=9.021, p\<0.001~Group\*Time: F=0.537, p=0.748~Estimates for group, time, and group\*time interactions~Group:~Estimate=0.913 (SE=1.085) \[CI LB=-1.228, UB=3.055\]~Time:~Post: estimate=-2.766 (0.853) \[-4.445, -1.087\]~2 months: estimate=-1.517 (0.862) \[-3.214, 0.180\]~4 months: estimate=-3.186 (0.862) \[-4.883, -1.489\]~6 months: estimate=-2.781 (0.872) \[-4.498, -1.065\]~8 months: estimate=-3.103 (0.872) \[-4.819, -1.386\]~Group\*Time:~Post: estimate=-1.157 (1.214) \[-3.547, 1.232\]~2 months: estimate=-1.361 (1.210) \[-3.742, 1.019\]~4 months: estimate= 0.183 (1.209) \[-2.196, 2.562\]~6 months: estimate=-0.508 (1.223) \[-2.914, 1.898\]~8 months: estimate=-0.127 (1.220) \[-2.529, 2.275\]"|3.055|-1.228|0.612
70948029|NCT00267098|141396947|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.729||||0.999|TWO_SIDED|95.0|0.592|0.889||BLOCK HF is a Bayesian study;a p-value was not used. Instead, a posterior probability,representing the probability that patients with BiV pacing have lower risk of events than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.|The hazard ratio corresponds to the time until death, a HF urgent care event or visit in which the LVESVI endpoint was met. Data beyond missed LVESVI measurements were excluded. A 95% credible interval was used instead of a 95% confidence interval.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of mortality, a heart failure urgent care visit, or significant increase in LVESVI as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a lower rate of this composite endpoint than patients with right ventricular pacing.||0.889|0.592|0.9990
70948030|NCT00267098|141396948|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.843||||0.865|TWO_SIDED|95.0|0.632|1.142||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, posterior probabilities, representing the probability that subjects with biventricular pacing have better outcomes, were calculated. A probability ≥ 0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio for death can take, and its likelihood of taking such values.|Because BLOCK HF was a Bayesian study, a 95% credible interval was used in lieu of a 95% confidence interval. This interval reflects the set of values the Hazard Ratio can take with 95% posterior probability.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of mortality as corresponding patients who receive right ventricular pacing.||1.142|0.632|0.865
70948031|NCT00267098|141396949|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.781||||0.9785|TWO_SIDED|95.0|0.615|0.991||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.|Because BLOCK HF was a Bayesian study, a 95% credible interval was used in lieu of a 95% confidence interval. This interval reflects the set of values the Hazard Ratio can take with 95% posterior probability.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of mortality or heart failure(HF)-related hospitalization as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a lower rate of death or first HF hospitalization than patients with right ventricular pacing.||0.991|0.615|0.9785
70954381|NCT03568318|141411403|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes only.|Least Squares (LS) Mean Difference|-41.79|STANDARD_ERROR_OF_MEAN|4.417|<|0.001|TWO_SIDED|95.0|-50.46|-33.11|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-33.11|-50.46|<0.001
71135653|NCT03932760|141772759|OTHER|Mean differences at the tested timepoints between VCI and AC. Models were also examined with the covariates of medication use and pregnant/post-partum status.|Mean estimates by time|0.016|STANDARD_ERROR_OF_MEAN|0.859||0.558|TWO_SIDED|95.0|-1.709|1.677|||Mixed Models Analysis||Time was treated as a categorical variable to allow for non-linear change over time. We present group, time, and group\*time estimates and their associated SE and CIs below. AC group and baseline timepoint are the reference categories.|We used multilevel generalized mixed modeling under an intent-to-treat approach to compare the outcome measures of GAD-7 between group 1 (VCI) and Group 2 (AC) at 6 time points during pregnancy and postpartum. We powered for the fixed effect of Intervention X Time using RMANOVA with alpha = 0.5, 6 time points, 0.3 for correlation between repeated measures, and a sample size of 192 total participants gives greater than 90% power to detect an effect size of 0.1.|"Overall test of significance for Fixed Effects. Higher GAD-7 scores signify worsened symptoms of depression.~Group VCI (AC reference): F=0.347, p=0.558~Time (Baseline as reference): F=4.973, p\<0.001~Group\*Time: F=0.417, p=0.837~Estimates for group, time, and group\*time interactions~Group:~Estimate=-0.0160 (SE=0.859) \[CI LB=-1.709, UB=1.677\]~Time:~Post: estimate=-1.780 (0.708) \[-3.173, -0.387\]~2 months: estimate=-0.615 (0.715) \[-2.023, 0.792\]~4 months: estimate=-1.416 (0.715) \[-2.824, -0.008\]~6 months: estimate=-1.625 (0.723) \[-3.049, -0.201\]~8 months: estimate=-1.542 (0.723) \[-2.966, -0.118\]~Group\*Time:~Post: estimate=-1.157 (1.214) \[-3.547, 1.232\]~2 months: estimate=-1.361 (1.210) \[-3.742, 1.019\]~4 months: estimate= 0.183 (1.209) \[-2.196, 2.562\]~6 months: estimate=-0.508 (1.223) \[-2.914, 1.898\]~8 months: estimate=-0.127 (1.220) \[-2.529, 2.275\]"|1.677|-1.709|0.558
71135654|NCT01279681|141772814|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.03||||0.93|TWO_SIDED|95.0|0.49|2.17|||Regression, Cox|||||2.17|0.49|0.93
71135655|NCT01454791|141772823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.45|TWO_SIDED||||||t-test, 2 sided|||||||0.45
71135656|NCT01454791|141772824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.6059|TWO_SIDED||||||t-test, 2 sided||not significant|||||0.6059
71135657|NCT01454791|141772825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.705|TWO_SIDED||||||t-test, 2 sided||not significant|||||0.705
71135658|NCT00086047|141772861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.39|STANDARD_DEVIATION|8.8||0.007|TWO_SIDED|95.0|1.57|9.22|||Mixed Models Analysis|||||9.22|1.57|0.007
71135659|NCT04640311|141772870|OTHER||Geometric mean ratio|1.028|||||TWO_SIDED|90.0|0.9699|1.09|||||Geometric mean ratio of Daprodustat Process 1 to Process 2 Dissolution Profile 1 has been presented.|||1.090|0.9699|
71135660|NCT04640311|141772870|OTHER||Geometric mean ratio|1.019|||||TWO_SIDED|90.0|0.9602|1.081|||||Geometric mean ratio of Daprodustat Process 1 to Process 2 Dissolution Profile 2 has been presented.|||1.081|0.9602|
70872178|NCT01438957|141229583|SUPERIORITY|||||||0.082|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.082
71135661|NCT04640311|141772871|EQUIVALENCE|Bioequivalence was to be determined if the 90 percent (%) confidence interval (CI) of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|1.029|||||TWO_SIDED|90.0|0.977|1.083|||||Geometric mean ratio of Daprodustat 1 mg Process 2 to Process 1 has been presented.|||1.083|0.9770|
71135662|NCT04640311|141772871|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9496|||||TWO_SIDED|90.0|0.8914|1.012|||||Geometric mean ratio of Daprodustat 2 mg Process 2 to Process 1 has been presented.|||1.012|0.8914|
71135663|NCT04640311|141772871|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|1.01|||||TWO_SIDED|90.0|0.9533|1.07|||||Geometric mean ratio of Daprodustat 4 mg Process 2 to Process 1 has been presented.|||1.070|0.9533|
71135664|NCT04640311|141772871|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9679|||||TWO_SIDED|90.0|0.9115|1.028|||||Geometric mean ratio of Daprodustat 6 mg Process 2 to Process 1 has been presented.|||1.028|0.9115|
71135665|NCT04640311|141772871|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9511|||||TWO_SIDED|90.0|0.8948|1.011|||||Geometric mean ratio of Daprodustat 8 mg Process 2 to Process 1 has been presented.|||1.011|0.8948|
71135666|NCT04640311|141772872|OTHER||Geometric mean ratio|1.042|||||TWO_SIDED|90.0|0.9308|1.166|||||Geometric mean ratio of Daprodustat Process 1 to Process 2 Dissolution Profile 1 has been presented.|||1.166|0.9308|
71135667|NCT04640311|141772872|OTHER||Geometric mean ratio|1.048|||||TWO_SIDED|90.0|0.9349|1.175|||||Geometric mean ratio of Daprodustat Process 1 to Process 2 Dissolution Profile 2 has been presented.|||1.175|0.9349|
71135668|NCT04640311|141772873|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9716|||||TWO_SIDED|90.0|0.8936|1.056|||||Geometric mean ratio of Daprodustat 1 mg Process 2 to Process 1 has been presented.|||1.056|0.8936|
71135669|NCT04640311|141772873|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9006|||||TWO_SIDED|90.0|0.8107|1.0|||||Geometric mean ratio of Daprodustat 2 mg Process 2 to Process 1 has been presented.|||1.000|0.8107|
71135670|NCT04640311|141772873|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9703|||||TWO_SIDED|90.0|0.8665|1.087|||||Geometric mean ratio of Daprodustat 4 mg Process 2 to Process 1 has been presented.|||1.087|0.8665|
71135671|NCT04640311|141772873|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9675|||||TWO_SIDED|90.0|0.8778|1.066|||||Geometric mean ratio of Daprodustat 6 mg Process 2 to Process 1 has been presented.|||1.066|0.8778|
71135672|NCT04640311|141772873|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.8606|||||TWO_SIDED|90.0|0.777|0.9532|||||Geometric mean ratio of Daprodustat 8 mg Process 2 to Process 1 has been presented.|||0.9532|0.7770|
71135673|NCT02707146|141772890|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|||||Chi-squared|||||||
71135674|NCT01284517|141772915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|1.08||0.176|||||||Mixed Models Analysis|||Null hypothesis (H0) assumes equal values between analysis groups in mean change from baseline in MADRS score, alternative hypothesis (HA) assumes unequal values between groups. Sample size determined by two-sample t-test. A mean difference of 3.25 units in change in MADRS score for the Lurasdone 20-120 mg arm over placebo with common standard deviation of 9 units was used. N=162 subjects per arm (total N=324) yields power of 90%. A 5% adjustment for drop-outs gives N=340, or N=170 per arm.||||0.176
71135675|NCT01284517|141772916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.141||0.095|||||||Mixed Models Analysis|||||||0.095
71135676|NCT01284517|141772917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|1.0||0.992|||||||ANCOVA|||||||0.992
71135677|NCT00040443|141772918|OTHER||Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|1.0|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<.05
71135678|NCT01588561|141772936|OTHER||||||||||||||||||Increased signal: Insula, Putamen, Cingulate, Paracingulate, Calcarine cortex, Lingual gyrus, Frontal pole, Fusiform gyrus, Cerebellum. Decreased signal:Thalamus, Temporal gyri, Hippocampus (left), Caudate, Cerebellum|||
71135679|NCT01588561|141772937|OTHER||||||||||||||||||Increased signal: Insula, Putamen, Pallidum, Cingulate, Thalamus, Operculum, OBF cortex, Lingual gyrus, Cerebellum. Decreased signal: Hippocampus (left), Parahippocampus (left), Caudate, Cerebellum|||
71135680|NCT01588561|141772938|OTHER||||||||||||||||||Increased signal: Insula (bilateral), Cingulate, Pretcentralgyrus, Thalamus (bilateral), Putamen (bilateral), Pallidum (bilateral), Amygdala (bilateral), Ventral tegmental area, Accumbens Nuclei. Decreased signal: Insula (left inferior), OBF cortex, Frontal\&Temporal poles, Hippocampus (bilateral), Parahippocampus (bilateral), Accumbens nuclei, Cerebellum|||
71135681|NCT01818596|141772943|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|30 participants with evaluable aGFR (measured by iohexol clearance) in either cohort would provide at least 90% power to show that aGFR change is \< 20% after participants were administered E/C/F/TAF. In this sample size/power computation, it was assumed that the intra-participant variation for aGFR is 0.17 mL/min on natural logarithm scale and a clinical meaningful boundary in aGFR change is 80% to 125%.|Difference in GLSM Ratio|98.94|||||TWO_SIDED|90.0|93.71|104.46|||||A parametric analysis of variance model using a mixed-effects model with repeated statement was fitted to the natural logarithm transferred aGFR obtained at postbaseline visits and baseline.|Comparison is made between the baseline value and the value from the Week 2, 4, or 8 visit and presented as a geometric least squares mean (GLSM) ratio with 90% confidence interval (CI). Postbaseline value and baseline value were used as test and reference, respectively.||104.46|93.71|
70862860|NCT01920555|141212624|SUPERIORITY||Mean Difference (Final Values)|1.37||||1|TWO_SIDED|95.0|-10.19|12.93||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||12.93|-10.19|1.00
71135682|NCT01818596|141772943|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|30 participants with evaluable aGFR (measured by iohexol clearance) in either cohort would provide at least 90% power to show that aGFR change is \< 20% after participants were administered E/C/F/TAF. In this sample size/power computation, it was assumed that the intra-participant variation for aGFR is 0.17 mL/min on natural logarithm scale and a clinical meaningful boundary in aGFR change is 80% to 125%.|Difference in GLSM Ratio|102.66|||||TWO_SIDED|90.0|97.11|108.53|||||A parametric analysis of variance model using a mixed-effects model with repeated statement was fitted to the natural logarithm transferred aGFR obtained at postbaseline visits and baseline.|Comparison is made between the baseline value and the value from the Week 24 visit and presented as a GLSM ratio with 90% CI. Week 24 value and baseline value were used as test and reference, respectively.||108.53|97.11|
70862861|NCT01920555|141212624|SUPERIORITY||Mean Difference (Final Values)|16.54||||0.03|TWO_SIDED|95.0|5.31|27.77||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||27.77|5.31|0.03
70872179|NCT01438957|141229584|SUPERIORITY|||||||0.451|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.451
70954382|NCT03568318|141411403|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes only.|LS Mean Difference|-33.08|STANDARD_ERROR_OF_MEAN|4.403|<|0.001|TWO_SIDED|95.0|-41.72|-24.44|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-24.44|-41.72|<0.001
71135683|NCT03801174|141772961|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.92||0.804|TWO_SIDED|95.0|-2.0|1.6|||Mixed Models Analysis|||||1.6|-2.0|.804
71135684|NCT03801174|141772962|SUPERIORITY||Mean Difference (Net)|50.2|STANDARD_ERROR_OF_MEAN|93.0||0.59|TWO_SIDED|95.0|-132.0|233.0|||Mixed Models Analysis|||||233|-132|.590
71135685|NCT03801174|141772963|SUPERIORITY||Mean Difference (Net)|806.0|STANDARD_ERROR_OF_MEAN|443.0||0.069|TWO_SIDED|95.0|-64.0|1675.0|||Mixed Models Analysis|||||1675|-64|.069
71135686|NCT01337336|141772977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.002||95.0|1.08|1.56|||Chi-squared||Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||1.56|1.08|0.002
71135687|NCT01337336|141772978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.002||95.0|1.02|2.38||COPD-related hospitalization|Chi-squared||Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||2.38|1.02|0.002
71135688|NCT01337336|141772978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.002||95.0|1.14|2.39||COPD-related ER visit|Chi-squared||Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||2.39|1.14|0.002
71135689|NCT01337336|141772978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.503||95.0|0.93|1.4|||Chi-squared|COPD-related physician + Rx visit|Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||1.40|0.93|0.503
71135690|NCT01337336|141772978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71|||<|0.001||95.0|1.26|2.31|||Chi-squared|COPD-related hospitalization/ER visit|Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||2.31|1.26|<0.001
71135691|NCT01337336|141772980|SUPERIORITY_OR_OTHER||Incident Rate Ratio|1.46||||0.0004||95.0|1.01|2.09||COPD-related hospitalization|t-test, 2 sided||Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||2.09|1.01|0.0004
71135692|NCT01337336|141772980|SUPERIORITY_OR_OTHER||Incident Rate Ratio|1.27||||0.208||95.0|0.89|1.82||COPD-related ER visit|t-test, 2 sided||Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||1.82|0.89|0.208
71135693|NCT01337336|141772980|SUPERIORITY_OR_OTHER||Incident Rate Ratio|1.09||||0.671||95.0|0.9|1.32||COPD-related physician + Rx visit|t-test, 2 sided||Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||1.32|0.90|0.671
71135694|NCT01337336|141772980|SUPERIORITY_OR_OTHER||Incident Rate Ratio|1.31||||0.009||95.0|1.05|1.72||COPD-related hospitalization/ER visit|t-test, 2 sided||Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||1.72|1.05|0.009
71135695|NCT01337336|141772980|SUPERIORITY_OR_OTHER||Incident Rate Ratio|1.16||||0.052||95.0|0.98|1.37||COPD-related hospitalization/ER visit/physician + Rx visit|t-test, 2 sided||Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||1.37|0.98|0.052
71135696|NCT02501590|141772986|OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71135697|NCT01618669|141772995|NON_INFERIORITY_OR_EQUIVALENCE|If the lower confidence bound of the 1-sided alpha level of 0.025 of the difference in the proportion of participants with majority reader self-agreement exceeded -0.075, non-inferiority would be demonstrated.|Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.015|||TWO_SIDED|95.0|-0.06|0.0|||||Difference equals Regadenoson After Peak Exercise minus Regadenoson Alone|||-0.00|-0.06|
71135698|NCT01618669|141772997|NON_INFERIORITY_OR_EQUIVALENCE|The lower confidence bound of the 1-sided alpha level of 0.025 of the difference in agreement rates must exceed -0.10 in order to demonstrate non-inferiority.|Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.063|||TWO_SIDED|95.0|-0.14|0.11|||||Difference equals Regadenoson After Peak Exercise minus Regadenoson Alone|||0.11|-0.14|
71135699|NCT01618669|141772998|NON_INFERIORITY_OR_EQUIVALENCE|The lower confidence bound of the 1-sided alpha level of 0.025 of the difference in agreement rates must exceed -0.133 in order to demonstrate non-inferiority. Non-inferiority could not be assessed because of insufficient data in the Regadenoson Alone group.|Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.027|||TWO_SIDED|95.0|-0.07|0.04||||||||0.04|-0.07|
71135700|NCT01618669|141772999|SUPERIORITY_OR_OTHER||Difference|0.02|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|95.0|-0.03|0.06||||||||0.06|-0.03|
70862862|NCT01920555|141212624|SUPERIORITY||Mean Difference (Final Values)|8.68||||0.82|TWO_SIDED|95.0|-2.81|20.16||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||20.16|-2.81|0.82
71135701|NCT01702558|141773011|SUPERIORITY||Difference in Response Rates|8.2||||0.336|TWO_SIDED|90.0|-4.5|20.9|||Fisher Exact||90% CI was estimated using Hauck-Anderson approach.|||20.9|-4.5|0.336
71135702|NCT03259087|141773048|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.25|||||TWO_SIDED|90.0|1.07|1.47|||||GMR is ratio of Experimental Group / Healthy Group|||1.47|1.07|
71135703|NCT03259087|141773048|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.7|||||TWO_SIDED|90.0|1.42|2.02|||||GMR is ratio of Experimental Group / Healthy Group|||2.02|1.42|
71135704|NCT03259087|141773048|OTHER||Geometric Least Squares Mean Ratio (GMR)|2.98|||||TWO_SIDED|90.0|2.2|4.04|||||GMR is ratio of Experimental Group / Healthy Group|||4.04|2.20|
71135705|NCT03259087|141773049|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.25|||||TWO_SIDED|90.0|1.06|1.46|||||GMR is ratio of Experimental Group / Healthy Group|||1.46|1.06|
71135706|NCT03259087|141773049|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.68|||||TWO_SIDED|90.0|1.41|1.99|||||GMR is ratio of Experimental Group / Healthy Group|||1.99|1.41|
71135707|NCT03259087|141773049|OTHER||Geometric Least Squares Mean Ratio (GMR)|2.91|||||TWO_SIDED|90.0|2.17|3.9|||||GMR is ratio of Experimental Group / Healthy Group|||3.90|2.17|
71135708|NCT03259087|141773050|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.21|||||TWO_SIDED|90.0|1.04|1.4|||||GMR is ratio of Experimental Group / Healthy Group|||1.40|1.04|
71135709|NCT03259087|141773050|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.59|||||TWO_SIDED|90.0|1.36|1.86|||||GMR is ratio of Experimental Group / Healthy Group|||1.86|1.36|
71135710|NCT03259087|141773050|OTHER||Geometric Least Squares Mean Ratio (GMR)|2.32|||||TWO_SIDED|90.0|1.82|2.97|||||GMR is ratio of Experimental Group / Healthy Group|||2.97|1.82|
71135711|NCT03259087|141773051|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.99|||||TWO_SIDED|90.0|0.84|1.16|||||GMR is ratio of Experimental Group / Healthy Group|||1.16|0.84|
71135712|NCT03259087|141773051|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.03|||||TWO_SIDED|90.0|0.9|1.18|||||GMR is ratio of Experimental Group / Healthy Group|||1.18|0.90|
71135713|NCT03259087|141773051|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.11|||||TWO_SIDED|90.0|0.95|1.29|||||GMR is ratio of Experimental Group / Healthy Group|||1.29|0.95|
71135714|NCT03259087|141773053|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.8|||||TWO_SIDED|90.0|0.68|0.94|||||GMR is ratio of Experimental Group / Healthy Group|||0.94|0.68|
71135715|NCT03259087|141773053|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.59|||||TWO_SIDED|90.0|0.49|0.7|||||GMR is ratio of Experimental Group / Healthy Group|||0.70|0.49|
71135716|NCT03259087|141773053|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.34|||||TWO_SIDED|90.0|0.25|0.45|||||GMR is ratio of Experimental Group / Healthy Group|||0.45|0.25|
71135717|NCT03259087|141773057|OTHER||Geometric Least Squares Mean Ratio (GMR)|3.97|||||TWO_SIDED|90.0|3.26|4.82|||||GMR is ratio of Experimental Group / Healthy Group|||4.82|3.26|
71135718|NCT03259087|141773057|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.58|||||TWO_SIDED|90.0|1.3|1.92|||||GMR is ratio of Experimental Group / Healthy Group|||1.92|1.30|
71135719|NCT03259087|141773058|OTHER||Geometric Least Squares Mean Ratio (GMR)|3.63|||||TWO_SIDED|90.0|3.03|4.36|||||GMR is ratio of Experimental Group / Healthy Group|||4.36|3.03|
71135720|NCT03259087|141773058|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.46|||||TWO_SIDED|90.0|1.22|1.75|||||GMR is ratio of Experimental Group / Healthy Group|||1.75|1.22|
71135721|NCT03259087|141773059|OTHER||Geometric Least Squares Mean Ratio (GMR)|2.61|||||TWO_SIDED|90.0|2.23|3.06|||||GMR is ratio of Experimental Group / Healthy Group|||3.06|2.23|
71135722|NCT03259087|141773059|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.09|||||TWO_SIDED|90.0|0.95|1.25|||||GMR is ratio of Experimental Group / Healthy Group|||1.25|0.95|
71135723|NCT03259087|141773060|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.98|||||TWO_SIDED|90.0|0.84|1.14|||||GMR is ratio of Experimental Group / Healthy Group|||1.14|0.84|
71135724|NCT03259087|141773060|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.94|||||TWO_SIDED|90.0|0.75|1.2|||||GMR is ratio of Experimental Group / Healthy Group|||1.20|0.75|
71135725|NCT03259087|141773061|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.99|||||TWO_SIDED|90.0|0.85|1.16|||||GMR is ratio of Experimental Group / Healthy Group|||1.16|0.85|
71135726|NCT03259087|141773061|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.94|||||TWO_SIDED|90.0|0.75|1.2|||||GMR is ratio of Experimental Group / Healthy Group|||1.20|0.75|
71135727|NCT03259087|141773062|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.25|||||TWO_SIDED|90.0|0.21|0.31|||||GMR is ratio of Experimental Group / Healthy Group|||0.31|0.21|
71135728|NCT03259087|141773062|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.63|||||TWO_SIDED|95.0|0.52|0.77|||||GMR is ratio of Experimental Group / Healthy Group|||0.77|0.52|
71135729|NCT03259087|141773066|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.9|||||TWO_SIDED|90.0|0.74|1.11|||||GMR is ratio of Experimental Group / Healthy Group|||1.11|0.74|
71135730|NCT03259087|141773066|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.64|||||TWO_SIDED|90.0|0.47|0.88|||||GMR is ratio of Experimental Group / Healthy Group|||0.88|0.47|
71135731|NCT03259087|141773066|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.3|||||TWO_SIDED|90.0|0.21|0.43|||||GMR is ratio of Experimental Group / Healthy Group|||0.43|0.21|
71135732|NCT03259087|141773067|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.75|||||TWO_SIDED|90.0|0.57|0.98|||||GMR is ratio of Experimental Group / Healthy Group|||0.98|0.57|
71135733|NCT03259087|141773067|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.4|||||TWO_SIDED|90.0|0.31|0.53|||||GMR is ratio of Experimental Group / Healthy Group|||0.53|0.31|
71135734|NCT03259087|141773067|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.13|||||TWO_SIDED|90.0|0.08|0.22|||||GMR is ratio of Experimental Group / Healthy Group|||0.22|0.08|
71135735|NCT03259087|141773068|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.9|||||TWO_SIDED|90.0|0.74|1.11|||||GMR is ratio of Experimental Group / Healthy Group|||1.11|0.74|
71135736|NCT03259087|141773068|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.64|||||TWO_SIDED|90.0|0.47|0.88|||||GMR is ratio of Experimental Group / Healthy Group|||0.88|0.47|
71135737|NCT03259087|141773068|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.3|||||TWO_SIDED|90.0|0.21|0.43|||||GMR is ratio of Experimental Group / Healthy Group|||0.43|0.21|
71135738|NCT04950465|141773085|SUPERIORITY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.14||0.2639|TWO_SIDED|95.0|-0.12|0.43|||ANCOVA|||||0.43|-0.12|0.2639
71135739|NCT04950465|141773086|SUPERIORITY|||||||0.6978|||||||Van Elteren Test|Due to non-normal residual analyses from ANCOVA a Van Elteren Test was performed.||Week 4||||0.6978
71135740|NCT04950465|141773086|SUPERIORITY|||||||0.813|||||||Van Elteren Test|Due to non-normal residual analyses from ANCOVA a Van Elteren Test was performed.||Week 8||||0.8130
71135741|NCT04950465|141773087|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.115||0.7645|TWO_SIDED|95.0|-0.26|0.19|||ANCOVA|||||0.19|-0.26|0.7645
71135742|NCT04950465|141773088|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.114||0.9728|TWO_SIDED|95.0|-0.23|0.22|||ANCOVA|||Week 4||0.22|-0.23|0.9728
71135743|NCT04950465|141773088|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.14||0.2968|TWO_SIDED|95.0|-0.13|0.42|||ANCOVA|||Week 8||0.42|-0.13|0.2968
71135744|NCT04950465|141773089|SUPERIORITY|||||||0.1682|||||||Van Elteren Test|Due to non-normal residual analyses from ANCOVA a Van Elteren Test was performed.||Week 4||||0.1682
71135745|NCT04950465|141773089|SUPERIORITY|||||||0.3937|||||||Van Elteren Test|Due to non-normal residual analyses from ANCOVA a Van Elteren Test was performed.||Week 8||||0.3937
71135746|NCT01379183|141773097|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71135747|NCT01379183|141773098|SUPERIORITY_OR_OTHER|||||||0.27|||||||ANCOVA|||||||0.27
71135748|NCT01379183|141773099|SUPERIORITY_OR_OTHER|||||||0.96|||||||ANCOVA|||||||0.96
71135749|NCT01379183|141773100|SUPERIORITY_OR_OTHER|||||||0.71|||||||ANCOVA|||||||0.71
71135750|NCT01379183|141773101|SUPERIORITY_OR_OTHER|||||||0.37|||||||ANCOVA|||||||0.37
71135751|NCT01379183|141773102|SUPERIORITY_OR_OTHER|||||||0.12|||||||ANCOVA|||||||0.12
71135752|NCT01695135|141773106|SUPERIORITY||Hazard Ratio (HR)|0.528||||0.0002|TWO_SIDED|95.0|0.376|0.74|||Log Rank|||||0.740|0.376|0.0002
71135753|NCT02562716|141773114|SUPERIORITY|||||||0.15|||||||Log Rank|||For each arm, the observed 2-year overall survival (OS) was compared to the null hypothesis of 40%, assuming a 58% alternative hypothesis, 88% power, and a 1-sided significance of 0.05.||||.15
71135754|NCT02562716|141773114|SUPERIORITY|||||||0.14|||||||Log Rank|||For each arm, the observed 2-year overall survival (OS) was compared to the null hypothesis of 40%, assuming a 58% alternative hypothesis, 88% power, and a 1-sided significance of 0.05.||||.14
71135755|NCT01775371|141773128|SUPERIORITY||Mean Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|95.0|0.6|1.5||The a priori threshold for statistical significance was 0.05.|Z-test 2-sided||The direction of the comparison is the Patient Controlled Analgesia minus the standard care group|The rate of change of NRS pain scores per hour was calculated using a mixed effects linear model. Time is represented as a linear spline with knot at 30 minutes to support the separate estimation of early and late phase rates of change. Fixed effects in the analysis includes study-group indicator, early and late phase time, and interactions between study-group and time. The principal hypothesis test was a z-test of the coefficient of the study group late phase interaction term.||1.5|0.6|<0.001
71135756|NCT01775371|141773129|SUPERIORITY|||||||0.025|||||||Chi-squared|||||||0.025
71135757|NCT01775371|141773130|SUPERIORITY|||||||0.003|||||||Chi-squared|||||||0.003
71135758|NCT01775371|141773131|OTHER|Responses occur with equal probability|||||<|0.001|||||||Chi-squared|One-sample chi-squared test of hypothesis that the responses occur with equal probability||These outcomes are based on the nurses who took care of patients in the study||||<0.001
71135759|NCT01775371|141773132|OTHER|All responses occur with equal probability|||||<|0.001|||||||Chi-squared|One-sample chi-squared test of hypothesis that the responses occur with equal probability||This outcome is based on the physicians who took care of the patients in the study||||<0.001
71135760|NCT01425801|141773139|SUPERIORITY_OR_OTHER||Least Squares Mean DIfference|0.405|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.353|0.458|||ANCOVA|Sequence, treatment and period as fixed effect factors, patient within sequence as random effect and baseline peak FEV1 at each period as a covariate||||0.458|0.353|<0.0001
71135761|NCT01425801|141773139|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.371|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.318|0.424|||ANCOVA|Sequence, treatment and period as fixed effect factors, patient within sequence as random effect and baseline peak FEV1 at each period as a covariate||||0.424|0.318|<0.0001
71135762|NCT01425801|141773139|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.322|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.269|0.375|||ANCOVA|Sequence, treatment and period as fixed effect factors, patient within sequence as random effect and baseline peak FEV1 at each period as a covariate||||0.375|0.269|<0.0001
71135763|NCT01425801|141773139|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.274|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.221|0.327|||ANCOVA|Sequence, treatment and period as fixed effect factors, patient within sequence as random effect and baseline peak FEV1 at each period as a covariate||||0.327|0.221|<0.0001
71135764|NCT02868554|141773157|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.07|TWO_SIDED||||||ANOVA|||||||0.07
71135765|NCT02868554|141773158|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.02|TWO_SIDED||||||ANOVA|||||||0.02
71135766|NCT04915729|141773166|NON_INFERIORITY|pre-specified non-inferiority margin for risk ratio = 0.937|Risk Ratio (RR)|1.0278|||||TWO_SIDED|95.0|0.9678|1.0915|||Modified Possion Regression Model|treatment = main effect; baseline NHISS, age + time to drug administration since stroke symptoms onset = continuous covariates|tenecteplase versus alteplase|||1.0915|0.9678|
71135767|NCT04915729|141773167|OTHER|log-binomial regression model|Risk Ratio (RR)|1.0671||||0.2412|TWO_SIDED|95.0|0.9573|1.1895||p-value was for superiority testing|Regression, Linear|treatment = main effect; baseline NHISS, age + time to drug administration since stroke symptoms onset = covariates|tenecteplase versus alteplase|||1.1895|0.9573|0.2412
71135768|NCT04915729|141773168|OTHER|Modified Poisson regression model|Risk Ratio (RR)|1.0078||||0.748|TWO_SIDED|95.0|0.9614|1.0564||p-value was for superiority testing|Regression, Linear|treatment = main effect; baseline NHISS, age + time to drug administration since stroke symptoms onset = continuous covariates|tenecteplase versus alteplase|||1.0564|0.9614|0.7480
70954383|NCT03568318|141411404|SUPERIORITY||LS Mean Difference|-41.45|STANDARD_ERROR_OF_MEAN|2.662|<|0.001|TWO_SIDED|95.0|-46.68|-36.22|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.||-36.22|-46.68|<0.001
70872180|NCT01438957|141229585|SUPERIORITY|||||||0.873|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.873
71135769|NCT04915729|141773169|OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.48||0.3511|TWO_SIDED|95.0|-1.4|0.5|||Mixed Models Analysis|baseline NIHSS, age, time to administration since stroke symptoms onset = linear covariates; treatment = fixed effects|Difference in LSmean tenecteplase vs alteplase|||0.50|-1.40|0.3511
71135770|NCT04915729|141773170|OTHER||Odds Ratio (OR)|1.0418||||0.4806|||||||Regression, Logistic|Assumption-free ordinal analysis|tenecteplase versus alteplase|||||0.4806
71135771|NCT04915729|141773171|OTHER|Poisson regression model|Risk Ratio (RR)|1.0189||||0.5116|TWO_SIDED|95.0|0.9635|1.0774|||Regression, Linear|treatment = main effect; baseline NHISS, age + time to drug administration since stroke symptoms onset = covariates|tenecteplase versus alteplase|||1.0774|0.9635|0.5116
71135772|NCT04915729|141773172|OTHER||Risk Ratio (RR)|1.005||||1|TWO_SIDED|95.0|0.37|2.701|||Suissa-Shuster test||tenecteplase versus alteplase|||2.701|0.370|1.000
71135773|NCT04915729|141773173|OTHER||Risk Ratio (RR)|0.795||||0.303|TWO_SIDED|95.0|0.513|1.232|||Chi-squared||tenecteplase versus alteplase|||1.232|0.513|0.303
71135774|NCT04915729|141773174|OTHER|Modified Poisson regression model|Risk Ratio (RR)|0.9215||||0.6345|TWO_SIDED|95.0|0.6578|1.2908||p-value was for superiority testing|Regression, Linear|treatment = main effect; baseline NHISS, age + time to drug administration since stroke symptoms onset = continuous covariates|tenecteplase versus alteplase|||1.2908|0.6578|0.6345
71135775|NCT05282927|141773176|SUPERIORITY||Mean Difference (Net)|-0.05||||0.92|TWO_SIDED|95.0|-1.07|0.98|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization: site complexity level (high complexity '1a', '1b' or '1c' vs. all others) and rurality (high sites serving ≥50% rural/highly rural Veterans vs. low sites serving \<50% rural/highly rural Veterans)||0.98|-1.07|0.92
71135776|NCT05282927|141773177|SUPERIORITY||Mean Difference (Net)|0.94||||0.056|TWO_SIDED|95.0|-0.03|1.9|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization: site complexity level (high complexity '1a', '1b' or '1c' vs. all others) and rurality (high sites serving ≥50% rural/highly rural Veterans vs. low sites serving \<50% rural/highly rural Veterans).||1.90|-0.03|0.056
71135777|NCT02294058|141773196|SUPERIORITY||Rate Ratio|0.518|||<|0.0001|TWO_SIDED|95.0|0.405|0.663||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.025 level.|Poisson regression model|Adjusted for region, Baseline age, number of gadolinium enhancing (GdE) lesions and included the natural log transformation of time as an offset term.||||0.663|0.405|<0.0001
71135778|NCT02294058|141773196|SUPERIORITY||Rate Ratio|0.688||||0.0013|TWO_SIDED|95.0|0.547|0.864||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.025 level.|Poisson Regression Model|Adjusted for region, Baseline age and the number of GdE lesions, and included the natural log transformation of time on study as an offset term.||||0.864|0.547|0.0013
71135779|NCT02294058|141773197|SUPERIORITY||Rate Ratio|0.517|||<|0.0001|TWO_SIDED|95.0|0.427|0.625||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.05 level.|Negative Binomial Regression Model|Adjusted for region, Baseline age and GdE lesions; included the natural log transformation of available MRI scans over 12 months as an offset term.|Rate Ratio = Ozanimod / IFN β-1a|||0.625|0.427|<0.0001
71135780|NCT02294058|141773197|SUPERIORITY||Rate Ratio|0.754||||0.0032|TWO_SIDED|95.0|0.625|0.91||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.05 level.|Negative binomial regression model|Adjusted for region, Baseline age and GdE lesions; included the natural log transformation of available MRI scans over 12 months as an offset term.|Rate Ratio = Ozanimod / IFN β-1a|||0.910|0.625|0.0032
71135781|NCT02294058|141773198|SUPERIORITY||Rate Ratio|0.37|||<|0.0001|TWO_SIDED|95.0|0.256|0.536||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.05 level.|Negative Binomial Regression Model|Adjusted for region, Baseline age and GdE lesions; included the natural log transformation of available MRI scans as an offset term.||||0.536|0.256|<0.0001
71135782|NCT02294058|141773198|SUPERIORITY||Rate Ratio|0.662||||0.0182|TWO_SIDED|95.0|0.471|0.932||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.05 level.|Negative binomial regression model|Adjusted for region, Baseline age and GdE lesions; included the natural log transformation of available MRI scans as an offset term.||||0.932|0.471|0.0182
71135783|NCT02294058|141773199|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.3055|TWO_SIDED|95.0|0.34|1.402|||Cox proportional hazards model|Based on the Cox proportional hazard model with factors for treatment group, adjusted for region, Baseline age, and Baseline EDSS score|Hazard Ratio (Ozanimod / IFN β-1a)|||1.402|0.340|0.3055
71135784|NCT02294058|141773199|SUPERIORITY||Hazard Ratio (HR)|0.886||||0.7163|TWO_SIDED|95.0|0.46|1.705|||Cox proportional hazards model|Based on the Cox proportional hazard model with factors for treatment group, adjusted for region, Baseline age and Baseline EDSS score|Hazard Ratio (Ozanimod / IFN β-1a)|||1.705|0.460|0.7163
71135785|NCT02294058|141773200|SUPERIORITY||Hazard Ratio (HR)|1.238||||0.6725|TWO_SIDED|95.0|0.46|3.337|||Cox proportional hazards model|Based on the Cox proportional hazard model with factors for treatment group, adjusted for region, Baseline age and Baseline EDSS score|Hazard Ratio (Ozanimod / IFN β-1a)|||3.337|0.460|0.6725
71135786|NCT02294058|141773200|SUPERIORITY||Hazard Ratio (HR)|1.535||||0.3755|TWO_SIDED|95.0|0.595|3.963|||Cox proportional hazard model|Based on the Cox proportional hazard model with factors for treatment group, adjusted for region, Baseline age and Baseline EDSS score|Hazard Ratio (Ozanimod / IFN β-1a)|||3.963|0.595|0.3755
71135787|NCT02294058|141773201|SUPERIORITY||Difference in Percentages|10.88||||0.0006|TWO_SIDED|95.0|4.84|16.92|||Cochran-Mantel-Haenszel|Based on the CMH test stratified by region and EDSS category per Interactive Voice Response System (IVRS)||||16.92|4.84|0.0006
71135788|NCT02294058|141773201|SUPERIORITY||Difference in Percentages|5.12||||0.113|TWO_SIDED|95.0|-1.07|11.32|||Cochran-Mantel-Haenszel|Based on the CMH test stratified by region and EDSS category per IVRS.||||11.32|-1.07|0.1130
71135789|NCT02294058|141773202|SUPERIORITY||Difference in Percentages|4.53||||0.118|TWO_SIDED|95.0|-1.19|10.24|||Cochran-Mantel-Haenszel|Based on the CMH test stratified by region and EDSS Scale category per IVRS.||||10.24|-1.19|0.1180
71135790|NCT02294058|141773202|SUPERIORITY||Difference in percentages|2.95||||0.3023|TWO_SIDED|95.0|-2.7|8.6|||Cochran-Mantel-Haenszel|Based on the CMH test stratified by region and EDSS Scale category per IVRS.||||8.60|-2.70|0.3023
71135791|NCT02294058|141773203|SUPERIORITY||||||<|0.0001|||||||Rank ANCOVA|Adjusted for region and EDSS category per IVRS||Due to the non-normal distribution of the data for brain volume loss, the analyses for percent change from baseline in normalized brain volume were compared using rank-ANCOVA, adjusted for region (Eastern Europe vs Rest of World), and EDSS category per IVRS, with the dependent variable as the residual of the rank of brain volume at Baseline regressed on rank of percent change.||||<0.0001
71135792|NCT02294058|141773203|SUPERIORITY|||||||0.0615|||||||Rank ANCOVA|Adjusted for region and EDSS Scale per IVRS||Due to the non-normal distribution of the data for brain volume loss, the analyses for percent change from baseline in normalized brain volume were compared using rank-ANCOVA, adjusted for region (Eastern Europe vs Rest of World), and EDSS category per IVRS, with the dependent variable as the residual of the rank of brain volume at Baseline regressed on rank of percent change.||||0.0615
71135793|NCT02294058|141773204|SUPERIORITY||LS Mean Difference|0.034||||0.129|TWO_SIDED|95.0|-0.01|0.077|||ANCOVA|Adjusted for region, EDSS category per IVRS and the Baseline MSFC score.||||0.077|-0.010|0.1290
71135794|NCT02294058|141773204|SUPERIORITY||LS Mean Difference|0.015||||0.4942|TWO_SIDED|95.0|-0.028|0.059|||ANCOVA|Adjusted for region, EDSS category per IVRS and the Baseline MSFC score||||0.059|-0.028|0.4942
71135795|NCT02294058|141773205|SUPERIORITY||Mean Difference (Final Values)|1.642||||0.0364|TWO_SIDED|95.0|0.104|3.18|||ANCOVA|Adjusted for region, EDSS category per IVRS, and the Baseline summary score.||Analysis of Physical Health Composite Summary||3.180|0.104|0.0364
71135796|NCT02294058|141773205|SUPERIORITY||Mean Difference (Final Values)|1.024||||0.1905|TWO_SIDED|95.0|-0.51|2.559|||ANCOVA|Adjusted for region, EDSS category per IVRS, and the Baseline summary score.||Analysis of Physical Health Composite Summary||2.559|-0.510|0.1905
71135797|NCT02294058|141773205|SUPERIORITY||Mean Difference (Final Values)|0.356||||0.7104|TWO_SIDED|95.0|-1.523|2.234|||ANCOVA|Adjusted for region, EDSS category per IVRS, and the Baseline summary score.||Analysis of Mental Health Composite Summary||2.234|-1.523|0.7104
71135798|NCT02294058|141773205|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.8587|TWO_SIDED|95.0|-2.045|1.705|||ANCOVA|Adjusted for region, EDSS category per IVRS, and the Baseline summary score.||Analysis of Mental Health Composite Summary||1.705|-2.045|0.8587
71135799|NCT01332994|141773286|SUPERIORITY_OR_OTHER|||||||0.1648|TWO_SIDED|||||Exact one-sided binomial test on single proportions with a significance level of alpha equals (=) 0.025. Null hypothesis: Proportion of participants reaching DAS28 remission (\<2.6) at Week 16 is ≤45 percent (%).|Exact one-sided binomial test|||||||0.1648
71135800|NCT01332994|141773322|SUPERIORITY_OR_OTHER|||||||0.7559|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Naive B-cell compartment||||0.7559
71135801|NCT01332994|141773322|SUPERIORITY_OR_OTHER|||||||0.8961|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Transitional B-cells||||0.8961
71135802|NCT01332994|141773322|SUPERIORITY_OR_OTHER|||||||0.7915|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Naive B-cells||||0.7915
71135803|NCT01332994|141773322|SUPERIORITY_OR_OTHER|||||||0.8081|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Memory B-cells||||0.8081
70954384|NCT03568318|141411404|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-32.13|STANDARD_ERROR_OF_MEAN|2.659|<|0.001|TWO_SIDED|95.0|-37.35|-26.91|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-26.91|-37.35|<0.001
71135804|NCT01332994|141773322|SUPERIORITY_OR_OTHER|||||||0.6574|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Pre-switch memory B-cells||||0.6574
71135805|NCT01332994|141773322|SUPERIORITY_OR_OTHER|||||||0.4553|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Post-switch memory B-cells||||0.4553
71135806|NCT01332994|141773322|SUPERIORITY_OR_OTHER|||||||0.2215|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||IgG-positive class-switched B-cells||||0.2215
71135807|NCT01332994|141773322|SUPERIORITY_OR_OTHER|||||||0.886|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||IgA-positive class-switched B-cells||||0.8860
71135808|NCT01332994|141773322|SUPERIORITY_OR_OTHER|||||||0.8693|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Double-negative B-cells||||0.8693
71135809|NCT01332994|141773322|SUPERIORITY_OR_OTHER|||||||0.9564|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Plasmablasts||||0.9564
71135810|NCT01332994|141773323|SUPERIORITY_OR_OTHER|||||||0.9993|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Naive B-cell compartment||||0.9993
71135811|NCT01332994|141773323|SUPERIORITY_OR_OTHER|||||||0.3596|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Transitional B-cells||||0.3596
71135812|NCT01332994|141773323|SUPERIORITY_OR_OTHER|||||||0.7435|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Naive B-cells||||0.7435
71135813|NCT01332994|141773323|SUPERIORITY_OR_OTHER|||||||0.7671|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Memory B-cells||||0.7671
71135814|NCT01332994|141773323|SUPERIORITY_OR_OTHER|||||||0.7912|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Pre-switch memory B-cells||||0.7912
71135815|NCT01332994|141773323|SUPERIORITY_OR_OTHER|||||||0.5595|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Post-switch memory B-cells||||0.5595
71135816|NCT01332994|141773323|SUPERIORITY_OR_OTHER|||||||0.3817|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, IgG-positive class-switched B-cells||||0.3817
71135817|NCT01332994|141773323|SUPERIORITY_OR_OTHER|||||||0.3623|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, IgA-positive class-switched B-cells||||0.3623
71135818|NCT01332994|141773323|SUPERIORITY_OR_OTHER|||||||0.7108|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Double-negative B-cells||||0.7108
71135819|NCT01332994|141773323|SUPERIORITY_OR_OTHER|||||||0.0639|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Plasmablasts||||0.0639
70954385|NCT03568318|141411405|SUPERIORITY||Adjusted Response Rate Difference|53.1|||<|0.001|TWO_SIDED|95.0|38.8|67.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||67.4|38.8|<0.001
71135820|NCT01332994|141773323|SUPERIORITY_OR_OTHER|||||||0.0186|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Naive B-cell compartment||||0.0186
71135821|NCT01332994|141773323|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Transitional B-cells||||0.0050
71135822|NCT01332994|141773323|SUPERIORITY_OR_OTHER|||||||0.0463|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Naive B-cells||||0.0463
71135823|NCT01332994|141773323|SUPERIORITY_OR_OTHER|||||||0.1919|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Memory B-cells||||0.1919
71135824|NCT01332994|141773323|SUPERIORITY_OR_OTHER|||||||0.3071|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Pre-switch memory B-cells||||0.3071
71135825|NCT01332994|141773323|SUPERIORITY_OR_OTHER|||||||0.1714|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Post-switch memory B-cells||||0.1714
71135826|NCT01332994|141773323|SUPERIORITY_OR_OTHER|||||||0.1746|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, IgG-positive class-switched B-cells||||0.1746
71135827|NCT01332994|141773323|SUPERIORITY_OR_OTHER|||||||0.1626|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, IgA-positive class-switched B-cells||||0.1626
71135828|NCT01332994|141773323|SUPERIORITY_OR_OTHER|||||||0.6304|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Double-negative B-cells||||0.6304
71135829|NCT01332994|141773323|SUPERIORITY_OR_OTHER|||||||0.3449|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Plasmablasts||||0.3449
71135830|NCT01332994|141773323|SUPERIORITY_OR_OTHER|||||||0.0919|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Naive B-cell compartment||||0.0919
71135831|NCT01332994|141773323|SUPERIORITY_OR_OTHER|||||||0.2189|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Transitional B-cells||||0.2189
71135832|NCT01332994|141773323|SUPERIORITY_OR_OTHER|||||||0.1386|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Naive B-cells||||0.1386
71135833|NCT01332994|141773323|SUPERIORITY_OR_OTHER|||||||0.6199|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Memory B-cells||||0.6199
71135834|NCT01332994|141773323|SUPERIORITY_OR_OTHER|||||||0.1019|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Pre-switch memory B-cells||||0.1019
71135835|NCT01332994|141773323|SUPERIORITY_OR_OTHER|||||||0.4353|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Post-switch memory B-cells||||0.4353
71135836|NCT01332994|141773323|SUPERIORITY_OR_OTHER|||||||0.3934|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, IgG-positive class-switched B-cells||||0.3934
71135837|NCT01332994|141773323|SUPERIORITY_OR_OTHER|||||||0.4196|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, IgA-positive class-switched B-cells||||0.4196
71135838|NCT01332994|141773323|SUPERIORITY_OR_OTHER|||||||0.5546|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Double-negative B-cells||||0.5546
71135839|NCT01332994|141773323|SUPERIORITY_OR_OTHER|||||||0.7695|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Plasmablasts||||0.7695
71135840|NCT01332994|141773324|SUPERIORITY_OR_OTHER|||||||0.6551|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Naive B-cell compartment||||0.6551
71135841|NCT01332994|141773324|SUPERIORITY_OR_OTHER|||||||0.6905|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Transitional B-cells||||0.6905
71135842|NCT01332994|141773324|SUPERIORITY_OR_OTHER|||||||0.9678|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Naive B-cells||||0.9678
71135843|NCT01332994|141773324|SUPERIORITY_OR_OTHER|||||||0.208|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Memory B-cells||||0.2080
71135844|NCT01332994|141773324|SUPERIORITY_OR_OTHER|||||||0.4778|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Pre-switch memory B-cells||||0.4778
71135845|NCT01332994|141773324|SUPERIORITY_OR_OTHER|||||||0.8526|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Post-switch memory B-cells||||0.8526
71135846|NCT01332994|141773324|SUPERIORITY_OR_OTHER|||||||0.7266|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, IgG-positive class-switched B-cells||||0.7266
71135847|NCT01332994|141773324|SUPERIORITY_OR_OTHER|||||||0.2011|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, IgA-positive class-switched B-cells||||0.2011
70954386|NCT03568318|141411405|SUPERIORITY||Adjusted Response Rate Difference|32.7|||<|0.001|TWO_SIDED|95.0|16.3|49.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||49.0|16.3|<0.001
70954387|NCT03568318|141411406|SUPERIORITY||Adjusted Response Rate Difference|55.4|||<|0.001|TWO_SIDED|95.0|41.4|69.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||69.5|41.4|<0.001
71135848|NCT01332994|141773324|SUPERIORITY_OR_OTHER|||||||0.7872|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Double-negative B-cells||||0.7872
71135849|NCT01332994|141773324|SUPERIORITY_OR_OTHER|||||||0.5377|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Plasmablasts||||0.5377
70954388|NCT03568318|141411406|SUPERIORITY||Adjusted Response Rate Difference|26.3|||<|0.001|TWO_SIDED|95.0|12.1|40.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||40.4|12.1|<0.001
71135850|NCT01332994|141773324|SUPERIORITY_OR_OTHER|||||||0.6238|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, Naive B-cell compartment||||0.6238
71135851|NCT01332994|141773324|SUPERIORITY_OR_OTHER|||||||0.2848|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, Transitional B-cells||||0.2848
71135852|NCT01332994|141773324|SUPERIORITY_OR_OTHER|||||||0.6238|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, Naive B-cells||||0.6238
71135853|NCT01332994|141773324|SUPERIORITY_OR_OTHER|||||||0.2848|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, Pre-switch memory B-cells||||0.2848
71135854|NCT01332994|141773324|SUPERIORITY_OR_OTHER|||||||0.7471|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, Post-switch memory B-cells||||0.7471
71135855|NCT01332994|141773324|SUPERIORITY_OR_OTHER|||||||0.7471|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, IgG-positive class-switched B-cells||||0.7471
71135856|NCT01332994|141773324|SUPERIORITY_OR_OTHER|||||||0.391|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, IgA-positive class-switched B-cells||||0.3910
71135857|NCT01332994|141773324|SUPERIORITY_OR_OTHER|||||||0.8729|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, Plasmablasts||||0.8729
71135858|NCT01332994|141773324|SUPERIORITY_OR_OTHER|||||||0.7261|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Naive B-cell compartment||||0.7261
71135859|NCT01332994|141773324|SUPERIORITY_OR_OTHER|||||||0.9338|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Transitional B-cells||||0.9338
71135860|NCT01332994|141773324|SUPERIORITY_OR_OTHER|||||||0.9074|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Naive B-cells||||0.9074
71135861|NCT01332994|141773324|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Memory B-cells||||<0.0001
71135862|NCT01332994|141773324|SUPERIORITY_OR_OTHER|||||||0.9338|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Pre-switch memory B-cells||||0.9338
71135863|NCT01332994|141773324|SUPERIORITY_OR_OTHER|||||||0.6515|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Post-switch memory B-cells||||0.6515
71135864|NCT01332994|141773324|SUPERIORITY_OR_OTHER|||||||0.8413|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, IgG-positive class-switched B-cells||||0.8413
71135865|NCT01332994|141773324|SUPERIORITY_OR_OTHER|||||||0.7244|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, IgA-positive class-switched B-cells||||0.7244
71135866|NCT01332994|141773324|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Double-negative B-cells||||<0.0001
71135867|NCT01332994|141773324|SUPERIORITY_OR_OTHER|||||||0.3848|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Plasmablasts||||0.3848
71135868|NCT00279916|141773343|SUPERIORITY|||||||0.18|||||||Chi-squared|||||||0.18
71135869|NCT00279916|141773344|SUPERIORITY|||||||0.24|||||||Chi-squared|||||||0.24
71135870|NCT02717494|141773359|OTHER||% with grade 3+ AEs, up to week 4 Step 1|2.0|||||TWO_SIDED|90.0|0.0|5.0|||||Confidence intervals were Exact Clopper-Pearson.|||5|0|
71135871|NCT02717494|141773359|OTHER||% with grade 3+ AEs, up to week 4 Step 1|3.0|||||TWO_SIDED|90.0|1.0|7.0|||||Confidence intervals were Exact Clopper-Pearson.|||7|1|
71135872|NCT02717494|141773359|OTHER||% with grade 3+ AEs up to week 4, Step 1|3.0|||||TWO_SIDED|90.0|1.0|8.0|||||Confidence intervals were Exact Clopper-Pearson.|||8|1|
71135873|NCT02717494|141773359|OTHER||% with grade 4+ AEs after week 4, Step 1|1.0|||||TWO_SIDED|90.0|0.0|4.0|||||Confidence intervals were Exact Clopper-Pearson.|||4|0|
71135874|NCT02717494|141773359|OTHER||% with grade 4+ AEs after week 4, Step 1|2.0|||||TWO_SIDED|90.0|0.0|5.0|||||||Confidence intervals were Exact Clopper-Pearson.|5|0|
71135875|NCT02717494|141773359|OTHER||% with grade 4+ AEs, after week 4 Step 1|3.0|||||TWO_SIDED|90.0|1.0|8.0|||||Confidence intervals were Exact Clopper-Pearson.|||8|1|
71135876|NCT02717494|141773359|OTHER||% with Grade 3+ related to treatment|1.0|||||TWO_SIDED|90.0|0.0|4.0|||||Confidence intervals were Exact Clopper-Pearson.|||4|0|
71135877|NCT02717494|141773359|OTHER||% with Grade 3+ related to treatment|1.0|||||TWO_SIDED|90.0|0.0|4.0|||||Confidence intervals were Exact Clopper-Pearson.|||4|0|
71135878|NCT02717494|141773359|OTHER||% with Grade 3+ related to treatment|1.0|||||TWO_SIDED|90.0|0.0|4.0|||||Confidence intervals were Exact Clopper-Pearson.|||4|0|
71135879|NCT02717494|141773360|OTHER||% with grade 3+ AEs, up to week 4 Step 2|0.0|||||TWO_SIDED|90.0|0.0|5.0|||||Confidence intervals were Exact Clopper-Pearson.|||5|0|
71135880|NCT02717494|141773360|OTHER||% with grade 3+ AEs, up to week 4 Step 2|0.0|||||TWO_SIDED|90.0|0.0|5.0|||||Confidence intervals were Exact Clopper-Pearson.|||5|0|
71135881|NCT02717494|141773361|OTHER||% infants with grade 3+ AEs|21.0|||||TWO_SIDED|90.0|14.0|28.0|||||Confidence intervals were Exact Clopper-Pearson.|||28|14|
71135882|NCT02717494|141773361|OTHER||% infants with grade 3+ AEs|20.0|||||TWO_SIDED|90.0|14.0|27.0|||||||Confidence intervals were Exact Clopper-Pearson.|27|14|
71135883|NCT02717494|141773361|OTHER||% infants with grade 3+ AEs|20.0|||||TWO_SIDED|90.0|14.0|27.0|||||Confidence intervals were Exact Clopper-Pearson.|||27|14|
71135884|NCT02717494|141773361|OTHER||% infants with congenital anomalies|17.0|||||TWO_SIDED|90.0|11.0|24.0|||||||Confidence intervals were Exact Clopper-Pearson.|24|11|
71135885|NCT02717494|141773361|OTHER||% infants with congenital anomalies|22.0|||||TWO_SIDED|90.0|15.0|29.0|||||||Confidence intervals were Exact Clopper-Pearson.|29|15|
71135886|NCT02717494|141773361|OTHER||% infants with congenital anomalies|13.0|||||TWO_SIDED|90.0|8.0|19.0|||||Confidence intervals were Exact Clopper-Pearson.|||19|8|
71135887|NCT02717494|141773361|OTHER||% infants with HIV infection|0.0|||||TWO_SIDED|90.0|0.0|3.0|||||||Confidence intervals were Exact Clopper-Pearson.|3|0|
71135888|NCT02717494|141773361|OTHER||% infants with HIV infection|0.0|||||TWO_SIDED|90.0|0.0|3.0|||||Confidence intervals were Exact Clopper-Pearson.|||3|0|
71135889|NCT02717494|141773361|OTHER||% infants with HIV infection|0.0|||||TWO_SIDED|90.0|0.0|2.0|||||Confidence intervals were Exact Clopper-Pearson.|||2|0|
71135890|NCT02717494|141773361|OTHER||% with pneumonia, meningitis or IPD|4.0|||||TWO_SIDED|90.0|2.0|9.0|||||Confidence intervals were Exact Clopper-Pearson.|||9|2|
71135891|NCT02717494|141773361|OTHER||% with pneumonia, meningitis or IPD|7.0|||||TWO_SIDED|90.0|3.0|12.0|||||Confidence intervals were Exact Clopper-Pearson.|||12|3|
71135892|NCT02717494|141773361|OTHER||% with pneumonia, meningitis or IPD|7.0|||||TWO_SIDED|90.0|3.0|12.0|||||Confidence intervals were Exact Clopper-Pearson.|||12|3|
71135893|NCT02717494|141773362|SUPERIORITY|This is the test to compare the two vaccine arms with respect to proportion of participants with \>=2 fold increase at day 28.||||||0.44||||||The threshold for statistical significance is 0.05.|Fisher Exact|Fisher's exact test was used because 50% of the cells had expected counts less than 5.||||||0.44
71135894|NCT02717494|141773362|SUPERIORITY|This is the test to compare the two vaccine arms with respect to proportion of participants with values \>=0.35ug/mL at day 28.||||||0.49||||||The threshold for statistical significance is 0.05.|Fisher Exact|Fisher's exact test was used because 50% of the cells had expected counts less than 5.||||||0.49
71135895|NCT02717494|141773362|OTHER||% vaccinees with >=2fold increase|96.0|||||TWO_SIDED|95.0|91.0|99.0|||||Confidence intervals were Exact Clopper-Pearson.|||99|91|
71135896|NCT02717494|141773362|OTHER||% vaccinees with >=2fold increase|98.0|||||TWO_SIDED|95.0|94.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|94|
71135897|NCT02717494|141773362|OTHER||% with >=2 fold increase|6.0|||||TWO_SIDED|95.0|3.0|12.0|||||Confidence intervals were Exact Clopper-Pearson.|||12|3|
71135898|NCT02717494|141773362|OTHER||% vaccinees with >=0.35ug/mL at day 28|99.0|||||TWO_SIDED|95.0|95.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|95|
71135899|NCT02717494|141773362|OTHER||% vaccinees with >=0.35ug/mL at day 28|100.0|||||TWO_SIDED|95.0|97.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|97|
71135900|NCT02717494|141773362|OTHER||% with >=0.35ug/mL at day 28|94.0|||||TWO_SIDED|95.0|88.0|97.0|||||Confidence intervals were Exact Clopper-Pearson.|||97|88|
71135901|NCT02717494|141773363|SUPERIORITY|||||||0.29||||||The threshold for statistical significance is 0.05.|Chi-squared|||||||0.29
71135902|NCT02717494|141773364|SUPERIORITY|||||||0.08||||||The threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.08
71135903|NCT02717494|141773365|SUPERIORITY|This is the test to compare the two vaccine arms with respect to proportion of participants with \>=2 fold increase at labor and delivery.||||||0.37||||||The threshold for statistical significance is 0.05.|Chi-squared|||||||0.37
71135904|NCT02717494|141773365|SUPERIORITY|This is the test to compare the two vaccine arms with respect to proportion of participants with \>=2 fold increase at 24 weeks post partum.||||||0.21|||||||Fisher Exact|Fisher's exact test was used because 50% of the cells had expected counts less than 5.||||||0.21
71135905|NCT02717494|141773366|OTHER||% vaccinees with >=2fold increase|96.0|||||TWO_SIDED|95.0|91.0|99.0||The threshold for statistical significance is 0.05.|||Confidence intervals were Exact Clopper-Pearson.|||99|91|
71135906|NCT02717494|141773366|OTHER||% vaccinees with >=2fold increase|98.0|||||TWO_SIDED|95.0|89.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|89|
71135907|NCT02717494|141773367|OTHER||% vaccinees with >=2fold increase|98.0|||||TWO_SIDED|95.0|94.0|100.0|||||||Confidence intervals were Exact Clopper-Pearson.|100|94|
71135908|NCT02717494|141773367|OTHER||% vaccinees with >=2fold increase|100.0|||||TWO_SIDED|95.0|93.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|93|
71135909|NCT02717494|141773368|OTHER||% infants with >=0.35ug/mL at week 16|100.0|||||TWO_SIDED|95.0|96.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|96|
71135910|NCT02717494|141773368|OTHER||% infants with >=0.35ug/mL at week 16|98.0|||||TWO_SIDED|95.0|93.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|93|
71135911|NCT02717494|141773368|OTHER||% infants with >=0.35ug/mL at week 16|97.0|||||TWO_SIDED|95.0|91.0|99.0|||||||Confidence intervals were Exact Clopper-Pearson.|99|91|
71135912|NCT02717494|141773368|OTHER||% infants with >=0.35ug/mL at week 24|100.0|||||TWO_SIDED|95.0|96.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|96|
71135913|NCT02717494|141773368|OTHER||% infants with >=0.35ug/mL at week 24|99.0|||||TWO_SIDED|95.0|95.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|95|
71135914|NCT02717494|141773368|OTHER||% infants with >=0.35ug/mL at week 24|98.0|||||TWO_SIDED|95.0|93.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|93|
71135915|NCT00731679|141773369|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||Regression, Logistic|The p-value was obtained from a logistic regression model with fixed effects for treatment arm and analysis center.||||||0.01
71135916|NCT00731679|141773370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Regression, Logistic|The p-value was obtained from a logistic regression model with fixed effects for treatment arm and analysis center.||||||0.005
71135917|NCT01598922|141773371|OTHER|Intent-to-treat (ITT) analyses following multiple imputation. Generalized Linear Models (GENLIN) predicting post-treatment HRSD scores in the imputed dataset. Covarying for pre-treatment HRSD scores, age and sex.|Odds Ratio (OR)|6.11|STANDARD_ERROR_OF_MEAN|1.68|<|0.0001|TWO_SIDED|95.0|2.814|9.403|||GENLIN|||||9.403|2.814|<0.0001
71135918|NCT01598922|141773372|OTHER||Cohen's d measure of effect size|-0.79||||0.024|TWO_SIDED|95.0|-1.25|-0.32||Hierarchical Linear Modeling (HLM) was applied to PHQ-9 data, adjusting for baseline PHQ-9 score. Group x Time interactions tested for between-group differences in slope of improvement of PHQ-9 scores.|hierarchical linear modeling|Age and sex were covariates. Cohen's d effect sizes are reported.||||-0.32|-1.25|.024
71135919|NCT01598922|141773373|OTHER|Hierarchical Linear Modeling (HLM) was applied to K-10 data, adjusting for baseline K-10 score. Group x Time interactions tested for between-group differences in slope of improvement of K-10 scores.|Cohen's d measure of effect size|-0.95||||0.003|TWO_SIDED|95.0|-1.42|-0.48|||HLM|||The Kessler Psychological Distress Scale (K-10) is a 10-item scale with total scores that can range from 0 to 50. Higher scores represent worse (more severe) psychological distress.||-0.48|-1.42|.003
71135920|NCT04739436|141773422|SUPERIORITY||Slope|5.29||||0.003|TWO_SIDED|95.0|1.8|8.79||Multiple comparisons were not conducted, so no adjustment of the p-value was necessary.|Regression, Linear|||A linear regression model was fit with outcome change in APHAB score between 3 months and baseline, predictor hearing aid fitting group (reference=bilateral), and covariate clinical site.||8.79|1.80|0.003
71135921|NCT04739436|141773423|SUPERIORITY|||||||0.584||||||No adjustments for multiple comparisons were done.|Kruskal-Wallis|||The null hypothesis is there is no difference in the GHABP question means between the groups at 3 months for the question: In this situation, what proportion of the time do you wear your hearing aid?||||0.584
71135922|NCT04739436|141773423|SUPERIORITY|||||||0.233|||||||Kruskal-Wallis|||The null hypothesis is there is no difference in the GHABP question means between the groups at 3 months for the question: In this situation, how much does your hearing aid help you?||||0.233
71135923|NCT04739436|141773423|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||The null hypothesis is there is no difference in the GHABP question means between the groups at 3 months for the question: In this situation, with your hearing aid, how much difficulty do you now have?||||0.010
71135924|NCT04739436|141773423|SUPERIORITY|||||||0.129|||||||Kruskal-Wallis|||The null hypothesis is there is no difference in the GHABP question means between the groups at 3 months for the question: For this situation, how satisfied are you with your hearing aid?||||0.129
71135925|NCT04739436|141773424|SUPERIORITY|||||||0.946|||||||Kruskal-Wallis|No adjustments for multiple comparisons were done.||The null hypothesis is there is no difference in the change from baseline to 3 months in the co-located BKB SIN test scores between the groups.||||0.946
71135926|NCT04739436|141773425|SUPERIORITY|||||||0.49|||||||Kruskal-Wallis|No adjustments for multiple comparisons were done.||The null hypotheses are there are no differences in the change from baseline to 3 months in WARRM recognition scores between the groups.||||0.490
71135927|NCT04739436|141773425|SUPERIORITY|||||||0.323||||||No adjustments for multiple comparisons were done.|t-test, 2 sided|||The null hypotheses are there are no differences in the change from baseline to 3 months in WARRM recall scores between the groups.||||0.323
71135928|NCT04739436|141773426|SUPERIORITY|||||||0.933||||||No adjustments for multiple comparisons were done.|t-test, 2 sided|||The null hypothesis is there is no difference in the SADL scores between the groups at 3 months.||||0.933
71135929|NCT04739436|141773426|SUPERIORITY|||||||0.929||||||No adjustments for multiple comparisons were done.|t-test, 2 sided|||The null hypothesis is there is no difference in the SADL scores between the groups at 6 months.||||0.929
71135930|NCT04739436|141773428|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|||The null hypothesis is there is no difference in the change from baseline to 3 months in SSQ scores between the groups.||||0.015
71135931|NCT04739436|141773428|SUPERIORITY|||||||0.886|||||||t-test, 2 sided|No adjustments for multiple comparisons were done.||The null hypothesis is there is no difference in the change from baseline to 6 months in SSQ scores between the groups.||||0.886
71135932|NCT04739436|141773429|SUPERIORITY|||||||0.137|||||||t-test, 2 sided|No adjustments for multiple comparisons were done.||The null hypothesis is there is no difference in the number of hours of hearing aid use between the groups in the right ear.||||0.137
71135933|NCT04739436|141773429|SUPERIORITY|||||||0.612|||||||t-test, 2 sided|No adjustments for multiple comparisons were done.||The null hypothesis is there is no difference in the number of hours of hearing aid use between the groups in the left ear.||||0.612
71135934|NCT04739436|141773431|SUPERIORITY|||||||0.108|||||||t-test, 2 sided|No adjustments for multiple comparisons were done.||The null hypothesis is there is no difference in the IOI-HA total score between the groups at 3 months.||||0.108
71135935|NCT04739436|141773431|SUPERIORITY|||||||0.988||||||No adjustments for multiple comparisons were done.|t-test, 2 sided|||The null hypothesis is there is no difference in the IOI-HA total score between the groups at 6 months.||||0.988
71135936|NCT04739436|141773434|SUPERIORITY|||||||0.264|||||||t-test, 2 sided|No adjustments for multiple comparisons were done.||The null hypothesis is there is no difference in the change in APHAB score from baseline to 6 months between the groups.||||0.264
71135937|NCT00676013|141773435|OTHER|ANOVA and all pairwise comparisons using Tukey test.|Multiple pairwise comparisons|0.05||||0.05|TWO_SIDED|||||0.05 is a threshold for statistical significance.|ANOVA|||We conducted a multiple four group comparison (all pairwise comparisons were conducted). An Anova was conducted to assess statistical significance.|0.05|||0.05
71135938|NCT00428948|141773436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.708|||<|0.0001|TWO_SIDED|95.0|-3.269|-2.147|||Linear mixed model||The variance of the random effect intercept was zero and resulted in a non-positive, definite variance-covariance matrix for the random effects.|The null hypothesis was that there was no difference in the percentage change per year in total kidney volume between the tolvaptan group and the placebo group.||-2.147|-3.269|<0.0001
71135939|NCT00428948|141773437|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.865||||0.0095|TWO_SIDED|95.0|0.775|0.965|||Recurrent event analysis||Tolvaptan divided by placebo.|The null hypothesis was that there was no difference in the ADPKD clinical progression events/100 follow-up years between the tolvaptan group and the placebo group.||0.965|0.775|0.0095
71135940|NCT00428948|141773438|SUPERIORITY_OR_OTHER||Difference in slope|0.977|||<|0.0001|TWO_SIDED|95.0|0.597|1.357|||Mixed Models Analysis|Derived from testing the time treatment interaction using linear mixed model in which both intercept and slope are fixed and random effects.||The null hypothesis was that there was no difference in the change in renal function per year between the tolvaptan group and the placebo group.||1.357|0.597|<0.0001
71135941|NCT00428948|141773439|SUPERIORITY_OR_OTHER||Difference in slope|-0.246||||0.552|TWO_SIDED|95.0|-1.059|0.566|||Mixed Models Analysis|Derived from testing the time treatment interaction using linear mixed model in which both intercept and slope are fixed and random effects.|Placebo minus tolvaptan.|The null hypothesis was that there was no difference in mean arterial blood pressure in non-hypertensive participants between the tolvaptan group and the placebo group.||0.566|-1.059|0.5520
71135942|NCT00428948|141773440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.1604|TWO_SIDED|95.0|-0.2|0.03|||ANCOVA|The analysis included baseline renal pain as a covariate.|Derived from ANCOVA with factors of treatment and baseline stratification factor interaction and covariate renal pain baseline.|The null hypothesis was that there was no difference in the change in renal pain between the tolvaptan group and the placebo group.||0.03|-0.20|0.1604
71135943|NCT00428948|141773441|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.996||||0.9704|TWO_SIDED|95.0|0.805|1.233|||Recurrent event analysis||Derived from rate and mean model of time to recurrent event analysis with factor treatment.|The null hypothesis was that there was no difference in the hypertensive events per 100 follow-up years in non-hypertensive participants between the tolvaptan group and the placebo group.||1.233|0.805|0.9704
71135944|NCT00428948|141773442|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.7532|TWO_SIDED|95.0|0.602|2.017|||Cochran-Mantel-Haenszel||Tolvaptan divided by placebo.|The null hypothesis was that there was no difference in the percentage of participants with a clinically sustained decrease of blood pressure leading to a sustained reduction in antihypertensive therapy between the tolvaptan group and the placebo group.||2.017|0.602|0.7532
71135945|NCT00181363|141773482|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71135946|NCT00181363|141773483|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71135947|NCT00181363|141773484|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71135948|NCT00181363|141773485|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71135949|NCT00181363|141773486|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71135950|NCT00997035|141773524|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.29|TWO_SIDED|95.0|0.57|1.18|||Regression, Cox|Cox proportional hazards regression to estimate the hazard of perforation or need for TPK.||The sample size was determined based on the primary end point: perforation or the need for TPK within 3 months. Simulation-based analyses estimated that a sample sizeof 240 study participants (120 per arm) would provide 80% power to detect a 15% difference in the 3-month perforation or need for TPK rate between topical antifungal plus oral voriconazole vs topical antifungal alone,with a 2-tailed α value of .05 and approximately 15%loss to follow-up.||1.18|0.57|0.29
71135951|NCT00997035|141773529|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.65|TWO_SIDED|95.0|0.49|1.57|||Regression, Cox|||||1.57|.49|0.65
71135952|NCT00997035|141773531|SUPERIORITY||||||<|0.001||||||Statistically significant after Holms-Šidák correction for multiple comparisons.|Fisher Exact|||||||<0.001
71135953|NCT02485561|141773562|SUPERIORITY||F-value|1.019||||0.362|TWO_SIDED||||||ANOVA|||||||.362
71135954|NCT02485561|141773563|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.098||0.024|TWO_SIDED||||||t-test, 2 sided|||||||.024
71135955|NCT02485561|141773563|SUPERIORITY||Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|0.074||0.75|TWO_SIDED||||||t-test, 2 sided|||||||.75
71135956|NCT02485561|141773564|SUPERIORITY||F-value|6.482||||0.002|TWO_SIDED||||||ANOVA|||||||.002
71135957|NCT02485561|141773564|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.15||0.91|TWO_SIDED||||||t-test, 2 sided|||||||.91
71135958|NCT02485561|141773564|SUPERIORITY||Mean Difference (Final Values)|0.716|STANDARD_ERROR_OF_MEAN|0.182|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
71135959|NCT02485561|141773565|SUPERIORITY||F-value|0.608||||0.55|TWO_SIDED||||||ANOVA|||||||0.55
71135960|NCT02485561|141773566|SUPERIORITY||F-value|16.31|||<|0.001|TWO_SIDED||||||ANOVA|||||||<.001
71135961|NCT02485561|141773566|SUPERIORITY||F-value|2.0||||0.14|TWO_SIDED||||||ANOVA|||||||0.14
71135962|NCT02485561|141773567|SUPERIORITY||F-value|1.68||||0.19|TWO_SIDED||||||ANOVA|||||||.19
71135963|NCT02485561|141773567|SUPERIORITY||F-value|0.021||||0.98|TWO_SIDED||||||ANOVA|||||||.98
71135964|NCT02485561|141773567|SUPERIORITY||F-value|0.312||||0.73|TWO_SIDED||||||ANOVA|||||||.73
71135965|NCT02485561|141773567|SUPERIORITY||F-value|0.702||||0.496|TWO_SIDED||||||ANOVA|||||||.496
71135966|NCT02485561|141773567|SUPERIORITY||F-value|1.88||||0.154|TWO_SIDED||||||ANOVA|||||||.154
71135967|NCT02485561|141773567|SUPERIORITY||F-value|0.667||||0.514|TWO_SIDED||||||ANOVA|||||||.514
71135968|NCT02485561|141773567|SUPERIORITY||F-value|0.666||||0.514|TWO_SIDED||||||ANOVA|||||||.514
71135969|NCT02485561|141773568|SUPERIORITY||F-value|0.59||||0.56|TWO_SIDED||||||ANOVA|||||||.56
71135970|NCT02485561|141773569|SUPERIORITY||F-value|0.18||||0.84|TWO_SIDED||||||ANOVA|||||||.84
71135971|NCT02485561|141773570|SUPERIORITY||F-value|1.16||||0.31|TWO_SIDED||||||ANOVA|||||||.31
71135972|NCT02485561|141773571|SUPERIORITY||F-value|1.17||||0.31|TWO_SIDED||||||ANOVA|||||||.31
71135973|NCT02485561|141773571|SUPERIORITY||F-value|0.056||||0.95|TWO_SIDED||||||ANOVA|||||||.95
71135974|NCT01126723|141773584|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15||||||The a priori threshold for statistical significance was set to 0.05.|Fisher Exact|||||||0.15
71135975|NCT03901144|141773591|SUPERIORITY||Mean Difference (Final Values)|-9.026|||<|0.001|TWO_SIDED|95.0|-12.562|-5.489|||ANCOVA|||Summary of TEWL (g/m2h) change from day 29 to day 31||-5.489|-12.562|<0.001
71135976|NCT03901144|141773591|SUPERIORITY||Mean Difference (Final Values)|-4.194||||0.021|TWO_SIDED|95.0|-7.76|-0.629|||ANCOVA|||Summary of TEWL (g/m2h) change from day 29 to day 31||-0.629|-7.760|0.021
70862863|NCT01920555|141212624|SUPERIORITY||Mean Difference (Final Values)|5.11||||1|TWO_SIDED|95.0|-8.83|19.05||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||19.05|-8.83|1.00
71135977|NCT03901144|141773591|SUPERIORITY||Mean Difference (Final Values)|-9.021|||<|0.001|TWO_SIDED|95.0|-12.602|-5.44|||ANCOVA|||Summary of TEWL (g/m2h) change from day 29 to day 31||-5.440|-12.602|<0.001
71135978|NCT03901144|141773592|SUPERIORITY||Mean Difference (Final Values)|-3.538|||<|0.001|TWO_SIDED|95.0|-5.114|-1.962|||ANCOVA|||Summary of Objective Erythema (2D Skin Imaging) change from day 29 to day 31||-1.962|-5.114|<0.001
71135979|NCT03901144|141773592|SUPERIORITY||Mean Difference (Final Values)|-1.748||||0.031|TWO_SIDED|95.0|-3.332|-0.164|||ANCOVA|||Summary of Objective Erythema (2D Skin Imaging) change from day 29 to day 31||-0.164|-3.332|0.031
71135980|NCT03901144|141773592|SUPERIORITY||Mean Difference (Final Values)|-4.744|||<|0.001|TWO_SIDED|95.0|-6.332|-3.156|||ANCOVA|||Summary of Objective Erythema (2D Skin Imaging) change from day 29 to day 31||-3.156|-6.332|<0.001
71135981|NCT03901144|141773593|SUPERIORITY||Mean Difference (Final Values)|-19.077||||0.002|TWO_SIDED|95.0|-31.325|-6.829|||ANCOVA|||Summary of Redness-Mexameter change from day 29 to day 31||-6.829|-31.325|0.002
71135982|NCT03901144|141773593|SUPERIORITY||Mean Difference (Final Values)|-4.493||||0.471|TWO_SIDED|95.0|-16.787|7.801|||ANCOVA|||||7.801|-16.787|0.471
71135983|NCT03901144|141773593|SUPERIORITY||Mean Difference (Final Values)|-27.035|||<|0.001|TWO_SIDED|95.0|-39.372|-14.698|||ANCOVA|||Summary of Redness - Mexameter change from day 29 to day 31||-14.698|-39.372|<0.001
71135984|NCT03901144|141773595|SUPERIORITY||Mean Difference (Net)|-0.354|||<|0.001|TWO_SIDED|95.0|-0.558|-0.15|||ANCOVA|||Summary of Visual Redness at day 31||-0.150|-0.558|<0.001
71135985|NCT03901144|141773595|SUPERIORITY||Mean Difference (Final Values)|-0.089||||0.392|TWO_SIDED|95.0|-0.292|0.115|||ANCOVA|||Summary of Visual Redness at day 31||0.115|-0.292|0.392
71135986|NCT03901144|141773595|SUPERIORITY||Mean Difference (Final Values)|-0.447|||<|0.001|TWO_SIDED|95.0|-0.652|-0.242|||ANCOVA|||Summary of Visual Redness at day 31||-0.242|-0.652|<0.001
71135987|NCT02714569|141773603|NON_INFERIORITY|Analyses were based on a pre-defined non-inferiority margin|Least Square Means Percentage|204.8|||||TWO_SIDED|90.0|161.9|259.0|||||Analysis was the estimate of the ratio fasted versus fed.|Geometric Mean Fed/Fasted Ratio of LY3202328 Cmax at 30 mg||259.0|161.9|
71135988|NCT02714569|141773605|NON_INFERIORITY|Analyses were based on a pre-defined non-inferiority margin|Least Squares Mean Percentage|193.3|||||TWO_SIDED|90.0|144.7|258.2||||||Geometric Mean Fed/Fasted Ratio of LY3202328 AUC(0-inf) at 30 mg||258.2|144.7|
71135989|NCT02714569|141773617|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|141.0|||||TWO_SIDED|90.0|67.9|293.0||||||Part B Placebo||293.0|67.9|
71135990|NCT02714569|141773617|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|70.8|||||TWO_SIDED|90.0|31.9|157.1||||||Part B 5 mg LY||157.1|31.9|
71135991|NCT02714569|141773617|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|109.2|||||TWO_SIDED|90.0|99.8|119.5||||||Part B 20 mg LY||119.5|99.8|
71135992|NCT02714569|141773617|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|107.7|||||TWO_SIDED|90.0|68.1|170.4||||||Part B 100 mg LY||170.4|68.1|
71135993|NCT02714569|141773617|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|213.3|||||TWO_SIDED|90.0|200.3|227.1||||||Part B 300 mg LY||227.1|200.3|
71135994|NCT02714569|141773617|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|115.4|||||TWO_SIDED|90.0|91.2|146.2||||||Part B Overall||146.2|91.2|
71135995|NCT02714569|141773618|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|155.0|||||TWO_SIDED|90.0|87.6|274.2||||||Part B Placebo||274.2|87.6|
71135996|NCT02714569|141773618|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|71.5|||||TWO_SIDED|90.0|40.7|125.3||||||Part B 5 mg LY||125.3|40.7|
71135997|NCT02714569|141773618|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratios (%)|122.4|||||TWO_SIDED|90.0|90.7|165.1||||||Part B 20 mg LY||165.1|90.7|
71135998|NCT02714569|141773618|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|136.6|||||TWO_SIDED|90.0|89.8|207.7||||||Part B 100 mg LY||207.7|89.8|
71135999|NCT02714569|141773618|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|132.6|||||TWO_SIDED|90.0|90.5|194.4||||||Part B 300 mg LY||194.4|90.5|
71136000|NCT02714569|141773618|OTHER|Ratio estimate without hypothesis|Geometric Least Squares Mean Ratio (%)|112.2|||||TWO_SIDED|90.0|93.2|135.1||||||Part B Overall||135.1|93.2|
71136001|NCT02714569|141773619|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|97.3|||||TWO_SIDED|90.0|80.4|117.8||||||Part B Placebo||117.8|80.4|
71136002|NCT02714569|141773619|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|57.5|||||TWO_SIDED|90.0|31.3|106.0||||||||106.0|31.3|
71136003|NCT02714569|141773619|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|96.2|||||TWO_SIDED|90.0|66.8|138.7||||||Part B 20 mg LY||138.7|66.8|
71136004|NCT02714569|141773619|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|80.9|||||TWO_SIDED|90.0|45.8|142.7||||||Part B 100 mg LY||142.7|45.8|
70948032|NCT00267098|141396950|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.695||||0.9886|TWO_SIDED|95.0|0.558|0.866||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.|The hazard ratio corresponds to the time from randomization to death or a visit in which LVESVI endpoint was met. Data beyond missed LVESVI measurements were excluded. A 95% credible interval was used instead of a 95% confidence interval.|"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or II who receive biventricular pacing have the same rate of mortality or significant increase in LVESVI as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a lower rate of death or significant increase in LVESVI than patients with right ventricular pacing."||0.866|0.558|0.9886
70954389|NCT03568318|141411407|SUPERIORITY||Adjusted Response Rate Difference|30.5|||<|0.001|TWO_SIDED|95.0|14.1|46.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||46.8|14.1|<0.001
71136005|NCT02714569|141773619|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|108.2|||||TWO_SIDED|90.0|40.2|291.2||||||Part B 300 mg LY||291.2|40.2|
71136006|NCT02714569|141773619|OTHER|Ratio estimate without hypothesis|Geometric Least Squares Mean Ratio (%)|87.9|||||TWO_SIDED|90.0|67.4|114.7||||||Part B Overall||114.7|67.4|
71136007|NCT02714569|141773620|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|96.0|||||TWO_SIDED|90.0|90.2|102.1||||||Part B Placebo||102.1|90.2|
71136008|NCT02714569|141773620|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|90.7|||||TWO_SIDED|90.0|59.8|137.6||||||Part B 5 mg LY||137.6|59.8|
71136009|NCT02714569|141773620|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|99.9|||||TWO_SIDED|90.0|75.9|131.5||||||Part B 20 mg LY||131.5|75.9|
71136010|NCT02714569|141773620|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|91.0|||||TWO_SIDED|90.0|67.5|122.7||||||Part B 100 mg LY||122.7|67.5|
71136011|NCT02714569|141773620|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|87.0|||||TWO_SIDED|90.0|42.0|180.5||||||Part B 300 mg LY||180.5|42.0|
71136012|NCT02714569|141773620|OTHER|Ratio estimate without hypothesis|Geometric Least Squares Mean Ratio (%)|93.5|||||TWO_SIDED|90.0|81.8|106.9||||||Part B Overall||106.9|81.8|
71136013|NCT00587678|141773621|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Linear repeated measures model|||||||0.32
71136014|NCT00587678|141773621|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||vs. baseline|Linear repeated measures model|||||||<0.01
71136015|NCT00587678|141773622|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Linear repeated measures model|||||||0.31
71136016|NCT00587678|141773622|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||vs. baseline|Linear repeated measures model|||||||<0.05
71136017|NCT00587678|141773623|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Linear repeated measures model|||||||0.71
71136018|NCT00587678|141773624|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||Linear repeated measures model|||||||0.67
71136019|NCT00587678|141773625|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Linear repeated measures model|||||||0.37
71136020|NCT00587678|141773625|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||vs. baseline|Linear repeated measures model|||||||<0.05
71136021|NCT00587678|141773626|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||Linear repeated measures model|||||||0.78
71136022|NCT00587678|141773627|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||Linear repeated measures model|||||||0.68
71136023|NCT00587678|141773628|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Linear repeated measures model|||||||<0.05
71136024|NCT00587678|141773629|SUPERIORITY_OR_OTHER||||||=|0.67||95.0|||||linear repeated measures model|||||||=0.67
71136025|NCT00587678|141773630|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||Linear repeated measures model|||||||0.77
71136026|NCT00587678|141773631|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Linear repeated measures model|||||||0.85
71136027|NCT00104650|141773632|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.28|||<|0.001||95.0|3.35|45.03|||Cochran-Mantel-Haenszel|Adjusted for cancer type stratification factor||||45.03|3.35|<0.001
71136028|NCT00104650|141773632|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.33||||0.002||95.0|1.74|16.36|||Cochran-Mantel-Haenszel|Adjusted for cancer type stratification factor||||16.36|1.74|0.002
71136029|NCT00104650|141773632|SUPERIORITY_OR_OTHER||Percentage of participants|77.8||||||95.0|60.8|89.9||||||||89.9|60.8|
71136030|NCT00104650|141773632|SUPERIORITY_OR_OTHER||Percentage of participants|63.6||||||95.0|45.1|79.6||||||||79.6|45.1|
71136031|NCT00104650|141773632|SUPERIORITY_OR_OTHER||Percentage of participants|28.6||||||95.0|14.6|46.3||||||||46.3|14.6|
71136032|NCT00104650|141773633|SUPERIORITY_OR_OTHER||Percentage of participants|63.9||||||95.0|46.2|79.2||||||||79.2|46.2|
71136033|NCT00104650|141773633|SUPERIORITY_OR_OTHER||Percentage of participants|63.6||||||95.0|45.1|79.6||||||||79.6|45.1|
71136034|NCT00104650|141773633|SUPERIORITY_OR_OTHER||Percentage of participants|37.1||||||95.0|21.5|55.1||||||||55.1|21.5|
71136035|NCT00104650|141773634|SUPERIORITY_OR_OTHER|||||||0.388|||||||ANCOVA|Adjusted for the stratum to which participants were originally assigned by the Interactive Voice Response System (IVRS)||||||0.388
71136036|NCT00104650|141773635|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.79|||<|0.001||95.0|2.01|7.15|||Regression, Cox|Stratified by cancer type and screening uNTx level||||7.15|2.01|<0.001
70948033|NCT00267098|141396951|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.704||||0.9904|TWO_SIDED|95.0|0.522|0.947||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.|Because BLOCK HF was a Bayesian study, a 95% credible interval was used in lieu of a 95% confidence interval. This interval reflects the set of values the Hazard Ratio can take with 95% posterior probability.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of first heart failure(HF)-related hospitalization as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a lower rate of first HF hospitalization than patients with right ventricular pacing.||0.947|0.522|0.9904
70948034|NCT00267098|141396952|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|-1.8||||0.637||||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Difference in Average Ranks|The subjects' individual rates of days hospitalized for HF were ranked, with lower ranks corresponding to fewer days hospitalized for HF.|The posterior probability that the BiV - RV difference in average ranks was below 0 (denoting that the BiV arm had lower ranks than the RV arm, on average) was calculated.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of days hospitalized for heart failure per year as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a lower rate of days hospitalized for HF than patients with right ventricular pacing.||||0.637
71136037|NCT00104650|141773635|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.32|||<|0.001||95.0|2.23|8.36|||Regression, Cox|Stratified by cancer type and screening uNTx level||||8.36|2.23|<0.001
71136038|NCT00104650|141773636|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.274||||0.006||95.0|0.11|0.687|||Regression, Cox|Adjusted for cancer type stratification factor and screening uNTx level||||0.687|0.110|0.006
71136039|NCT00104650|141773636|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.199||||0.001||95.0|0.076|0.523|||Regression, Cox|Adjusted for cancer type stratification factor and screening uNTx level||||0.523|0.076|0.001
71136040|NCT00104650|141773637|SUPERIORITY_OR_OTHER|||||||0.056|||||||ANCOVA|Adjusted for the stratum to which participants were originally assigned by the Interactive Voice Response System (IVRS)||||||0.056
71136041|NCT00104650|141773638|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.162||||0.105||95.0|0.018|1.465|||Regression, Cox|||||1.465|0.018|0.105
71136042|NCT00104650|141773638|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.573||||0.43||95.0|0.143|2.289|||Regression, Cox|||||2.289|0.143|0.430
71136043|NCT00104650|141773639|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.26||||||95.0|0.05|1.44||||||||1.44|0.05|
71136044|NCT00104650|141773639|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||||95.0|0.08|1.76||||||||1.76|0.08|
70872181|NCT01438957|141229586|SUPERIORITY|||||||0.374|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.374
71136045|NCT04184297|141773691|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.76|0.96|||Regression, Cox|The method was used to calculate hazard ratios with 95% confidence intervals.|Hazard ratio of Tiotropium+Olodaterol versus LABA/LAMA/ICS.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid (LABA/LAMA/ICS) therapy combination on the risk of first COPD exacerbation for overall population.||0.96|0.76|
71136046|NCT04184297|141773692|OTHER||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.64|1.07|||Regression, Cox|This method was used to calculate hazard ratios with 95% confidence intervals.|Hazard ratio of Tiotropium+Olodaterol versus LABA/LAMA/ICS.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid (LABA/LAMA/ICS) therapy combination on the risk of a hospitalization for community-acquired pneumonia for overall population.||1.07|0.64|
71136047|NCT04184297|141773693|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.91|1.19|||Regression, Cox|The method was used to calculate hazard ratios with 95% confidence intervals.|Hazard ratio of Tiotropium+Olodaterol versus LABA/LAMA/ICS.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid (LABA/LAMA/ICS) therapy combination on the risk of first COPD exacerbation for overall population.||1.19|0.91|
71136048|NCT02412098|141773694|OTHER||Geometric Least Square Mean (GLSM) Ratio|73.54|||||TWO_SIDED|90.0|41.92|129.01|||||A 90% CI was constructed for the GLSM ratio of AUCinf in the hepatic impairment group versus matched control.|An analysis of variance (ANOVA) appropriate for a parallel design was fit to the natural logarithmic transformation of eleclazine AUCinf.||129.01|41.92|
71136049|NCT02412098|141773694|OTHER||GLSM Ratio (%)|127.8|||||TWO_SIDED|90.0|73.57|222.01|||||A 90% CI was constructed for the GLSM ratio of AUCinf in the hepatic impairment group versus matched control.|An analysis of variance (ANOVA) appropriate for a parallel design was fit to the natural logarithmic transformation of eleclazine AUCinf.||222.01|73.57|
71136050|NCT02412098|141773695|OTHER||GLSM Ratio (%)|80.82|||||TWO_SIDED|90.0|45.11|144.79|||||A 90% CI was constructed for the GLSM ratio of AUCinf in the hepatic impairment group versus matched control.|ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of GS-623134 AUCinf.||144.79|45.11|
71136051|NCT02412098|141773695|OTHER||GLSM Ratio (%)|73.52|||||TWO_SIDED|90.0|47.83|113.02||ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of GS-623134 AUCinf.|||A 90% CI was constructed for the GLSM ratio of AUCinf in the hepatic impairment group versus matched control.|||113.02|47.83|
71136052|NCT02412098|141773696|OTHER||GLSM Ratio (%)|66.55|||||TWO_SIDED|90.0|53.33|83.04|||||A 90% CI was constructed for the GLSM ratio of Cmax in the hepatic impairment group versus matched control.|ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of eleclazine Cmax.||83.04|53.33|
71136053|NCT02412098|141773696|OTHER||GLSM Ratio (%)|102.06|||||TWO_SIDED|90.0|83.03|125.45|||||A 90% CI was constructed for the GLSM ratio of Cmax in the hepatic impairment group versus matched control.|ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of eleclazine Cmax.||125.45|83.03|
71136054|NCT02412098|141773697|OTHER||GLSM Ratio (%)|76.24|||||TWO_SIDED|90.0|50.65|114.77|||||A 90% CI was constructed for the GLSM ratio of Cmax in the hepatic impairment group versus matched control.|ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of GS-623134 Cmax.||114.77|50.65|
71136055|NCT02412098|141773697|OTHER||GLSM Ratio (%)|71.06|||||TWO_SIDED|90.0|44.59|113.25|||||A 90% CI was constructed for the GLSM ratio of Cmax in the hepatic impairment group versus matched control.|ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of GS-623134 Cmax.||113.25|44.59|
71136056|NCT03089580|141773700|SUPERIORITY|Paired, Student's t-test was used to contrast the outcome variable of TBUT in the treated eye versus the sham eye from visit 1 to visit 5. The null hypothesis to be tested is one of no change from pre- to post treatment, with a Type I error probability of 0.05 for the primary outcome assessment. The pattern of change over the 4 treatment visits in these continuous variables will be assessed using mixed, linear regression. SAS version 9.4 statistical software (SAS Institute, Cary, NC) was used.||||||0.3|||||||paired t test|||The primary study outcome of pre to post change in TBUT within the treated eye and also the untreated, control eye dictated the use of a paired statistical approach to sample size estimation. Clinically relevant pre to post TBUT increase of 3 seconds with a standard deviation of 4.5 seconds was used. Type I and II error estimates used were standard for a non-pivotal study, 0.05 \& 0.20. The estimated the sample size needed detect this difference in TBUT is 27 subjects.||||0.3
70862864|NCT01920555|141212624|SUPERIORITY||Mean Difference (Final Values)|-6.64||||1|TWO_SIDED|95.0|-19.87|6.59||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||6.59|-19.87|1.00
70862865|NCT01920555|141212624|SUPERIORITY||Mean Difference (Final Values)|7.64||||1|TWO_SIDED|95.0|-5.26|20.53||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||20.53|-5.26|1.00
70954390|NCT03568318|141411407|SUPERIORITY||Adjusted Response Rate Difference|24.5||||0.003|TWO_SIDED|95.0|8.2|40.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||40.8|8.2|0.003
71136057|NCT03089580|141773701|SUPERIORITY|The p-value results from a test of the hypothesis that the change in OSDI from visit 1 does not differ from zero. Change distributions that met normal distribution test criteria (Shapiro-Wilk p-value \>0.05) were tested with the paired Student's t-test; non-normal change distributions (at visits 2 \& 4) were tested with the non-parametric Wilcoxon signed rank test.||||||0.2026|||||||paired t test|||||||0.2026
71136058|NCT03087513|141773702|SUPERIORITY||||||<|0.01||||||In all cases of motor evoked potential changes, a P-value of 0.05 was considered significant.|Mixed Models Analysis|As the amplitude values were non-normally distributed, the Mann-Whitney U test was performed to compare the two groups.||In total, 40 patients were randomised for the study. Data from 2 patients were excluded as the crossover arm could not be completed due to intraoperative MEP change (n=1) and the equipment malfunction (n=1). The data distributions were tested for normality with the Kolmogorov-Smirnov test.||||<0.01
71136059|NCT02784171|141773722|SUPERIORITY|||||||0.0372|||||||Log Rank|||||||0.0372
70954391|NCT03568318|141411408|SUPERIORITY||Adjusted Response Rate Difference|52.0|||<|0.001|TWO_SIDED|95.0|37.3|66.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||66.7|37.3|<0.001
71136060|NCT02679287|141773794|SUPERIORITY||Mean Difference (Final Values)|1.8|||<|0.0001|TWO_SIDED|95.0|1.2|2.4|||Mixed Models Analysis|||The null hypothesis is that there is no difference in percentage of time \<70 mg/dL in SAP vs. evening-overnight CLC session. Change in HbA1c during study sessions was used as a covariate of the model.||2.4|1.2|<0.0001
71136061|NCT05298202|141773889|SUPERIORITY|time x treatment ANOVA||||||0.284||||||difference between treatment and control|ANOVA|||||||0.284
71136062|NCT05298202|141773890|SUPERIORITY|||||||0.177|||||||t-test, 2 sided|||||||.177
71136063|NCT05298202|141773891|SUPERIORITY|||||||0.122|||||||t-test, 2 sided|||||||.122
71136064|NCT05298202|141773892|SUPERIORITY|||||||0.038|||||||ANOVA|time x treatment anova||||||.038
71136065|NCT05298202|141773893|SUPERIORITY|||||||0.976|||||||ANOVA|||||||.976
71136066|NCT05298202|141773894|SUPERIORITY|||||||0.747|||||||ANOVA|||||||.747
71136067|NCT01875159|141773895|SUPERIORITY_OR_OTHER||||||<|0.05|||||||GEE gamma regression models|||\>80% probability of detecting at least a 36% reduction in intermittent hypoxia events/hour of recording and in sec/hour \<90% oxygen saturation/hour of recording||||<0.05
71136068|NCT01389882|141773914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.007|STANDARD_DEVIATION|2.015||0.043|TWO_SIDED|95.0|0.036|1.978|||Paired t-test|||||1.978|0.036|0.043
71136069|NCT01389882|141773915|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.232|STANDARD_DEVIATION|0.841||0.245|TWO_SIDED|95.0|-0.637|0.174|||Paired t-test|||||0.174|-0.637|0.245
71136070|NCT01389882|141773916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026|STANDARD_DEVIATION|0.095||0.257|TWO_SIDED|95.0|-0.02|0.714|||Paired t-test|||||0.714|-0.020|0.257
70948035|NCT00267098|141396953|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.012||||0.591|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes at 6 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 6 month changes in NYHA classification were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in NYHA classification from randomization to 6 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.591
70948036|NCT00267098|141396953|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.126||||0.986|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 12 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 12 month changes in NYHA classification were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in NYHA classification from randomization to 12 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.986
70948037|NCT00267098|141396953|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.039||||0.726|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 12 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 18 month changes in NYHA classification were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in NYHA classification from randomization to 18 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.726
70948038|NCT00267098|141396953|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.035||||0.701|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 24 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 24 month changes in NYHA classification were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in NYHA classification from randomization to 24 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.701
70948039|NCT00267098|141396954|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.002||||0.534|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes at 6 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 6 month change in HF Stage were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in HF stage from randomization to 6 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.534
70948040|NCT00267098|141396954|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.026||||0.825|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 12 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 12 month changes in HF Stage were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' change in HF stage from randomization to 12 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.825
70954392|NCT03568318|141411408|SUPERIORITY||Adjusted Response Rate Difference|27.1||||0.001|TWO_SIDED|95.0|11.1|43.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||43.1|11.1|0.001
70954393|NCT03568318|141411409|SUPERIORITY||Adjusted Response Rate Difference|23.5||||0.006|TWO_SIDED|95.0|6.9|40.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||40.1|6.9|0.006
71136071|NCT01389882|141773917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|STANDARD_DEVIATION|1.541||0.601|TWO_SIDED|95.0|-0.554|0.931|||Paired t-test|||||0.931|-0.554|0.601
71136072|NCT01389882|141773918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.149|STANDARD_DEVIATION|0.355||0.085|TWO_SIDED|95.0|-0.32|0.023|||Paired t-test|||||0.023|-0.320|0.085
71136073|NCT01389882|141773919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.516|STANDARD_DEVIATION|9.786||0.002|TWO_SIDED|95.0|1.799|11.232|||Wilcoxon signed-rank test|||||11.232|1.799|0.002
71136074|NCT01389882|141773920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.69|STANDARD_DEVIATION|2.516||0.009|TWO_SIDED|95.0|0.478|2.904|||Paired t-test, 2-sided|||||2.904|0.478|0.009
71136075|NCT01389882|141773921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.692|STANDARD_DEVIATION|2.192||0.314|TWO_SIDED|95.0|-0.364|1.749|||Wilcoxon signed-rank test|||||1.749|-0.364|0.314
71136076|NCT01389882|141773922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007|STANDARD_DEVIATION|0.047||0.515|TWO_SIDED|95.0|-0.03|0.016|||Paired t-test|||||0.016|-0.030|0.515
71136077|NCT01389882|141773923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1105|STANDARD_DEVIATION|7.501||0.949|TWO_SIDED|95.0|-3.505|3.726|||Paired t-test|||||3.726|-3.505|0.949
70954394|NCT03568318|141411409|SUPERIORITY||Adjusted Response Rate Difference|22.7||||0.007|TWO_SIDED|95.0|6.2|39.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||39.2|6.2|0.007
71136078|NCT01389882|141773924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.053|STANDARD_DEVIATION|12.081||0.709|TWO_SIDED|95.0|-4.77|6.875|||Paired t-test|||||6.875|-4.770|0.709
71136079|NCT01389882|141773925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.274|STANDARD_DEVIATION|2.233||0.6|TWO_SIDED|95.0|-1.35|0.802|||Paired t-test|||||0.802|-1.350|0.600
71136080|NCT01116401|141773946|SUPERIORITY_OR_OTHER|||||||0.007|||||||Regression, Linear|||||||0.007
71136081|NCT01116401|141773947|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Regression, Linear|||||||<0.01
71136082|NCT00669214|141773988|SUPERIORITY_OR_OTHER||Difference in proportion|0.163||||0.1054||95.0|-0.063|0.393|||Fisher Exact|The p-value was based on the Fisher exact test for a 2x2 contingency table.||||0.393|-0.063|0.1054
71136083|NCT00669214|141773990|SUPERIORITY_OR_OTHER||Difference in proportion|0.155||||0.2404||95.0|-0.072|0.388|||Fisher Exact|The p-value was based on the Fisher exact test for a 2x2 contingency table.||||0.388|-0.072|0.2404
71136084|NCT00669214|141773992|SUPERIORITY_OR_OTHER||Difference in proportion|0.228||||0.0366||95.0|0.003|0.452|||Fisher Exact|The p-value was based on the Fisher exact test for a 2x2 contingency table.||||0.452|0.003|0.0366
71136085|NCT00669214|141773994|SUPERIORITY_OR_OTHER||Difference in mean change from Day 0|3.33||||0.1816||95.0|-2.811|9.471|||Student T-test|||||9.471|-2.811|0.1816
71136086|NCT00669214|141773996|SUPERIORITY_OR_OTHER||Difference in mean change from Day 0|1.19||||0.0435||95.0|-0.161|2.532|||Student T-test|||||2.532|-0.161|0.0435
71136087|NCT00669214|141773998|SUPERIORITY_OR_OTHER|||||||0.0224||95.0|||||Wilcoxon rank sum|||||||0.0224
71136088|NCT00754377|141774000|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||||||0.02
71136089|NCT00754377|141774001|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
71136090|NCT01276639|141774003|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.46|||<|0.0001|TWO_SIDED|95.0|4.4|15.03||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||15.03|4.40|<0.0001
71136091|NCT01276639|141774003|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.45|||<|0.0001|TWO_SIDED|95.0|9.01|31.88||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||31.88|9.01|<0.0001
71136092|NCT01276639|141774003|SUPERIORITY_OR_OTHER||Percent difference|17.29|STANDARD_ERROR_OF_MEAN|3.66|<|0.0001|TWO_SIDED|95.0|10.11|24.47|||Normal approximation|||||24.47|10.11|<0.0001
71136093|NCT01276639|141774004|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.93|||<|0.0001|TWO_SIDED|95.0|5.25|21.84||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||21.84|5.25|<0.0001
71136094|NCT01276639|141774004|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.81|||<|0.0001|TWO_SIDED|95.0|11.9|49.86||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||49.86|11.90|<0.0001
71136095|NCT01276639|141774004|SUPERIORITY_OR_OTHER||Percent difference|19.22|STANDARD_ERROR_OF_MEAN|3.65|<|0.0001|TWO_SIDED|95.0|12.07|26.37|||Normal approximation|||||26.37|12.07|<0.0001
71136096|NCT01276639|141774005|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-53.56|STANDARD_ERROR_OF_MEAN|4.34|<|0.0001|TWO_SIDED|95.0|-62.08|-45.04||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16,PASI90 response at Week 16, change in Dermatology Life Quality Index(DLQI) total score at Week 16,PGA response at Week 4,PASI75 at Week 4, change in DLQI total score at Week 4, percent change in Nail Psoriasis Severity Index(NAPSI) score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-45.04|-62.08|<0.0001
71136097|NCT01276639|141774005|SUPERIORITY_OR_OTHER||LS mean difference|-68.82|STANDARD_ERROR_OF_MEAN|4.34|<|0.0001|TWO_SIDED|95.0|-77.33|-60.31||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16,PASI90 response at Week 16, change in Dermatology Life Quality Index(DLQI) total score at Week 16,PGA response at Week 4,PASI75 at Week 4, change in DLQI total score at Week 4, percent change in Nail Psoriasis Severity Index(NAPSI) score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-60.31|-77.33|<0.0001
70862866|NCT01920555|141212624|SUPERIORITY||Mean Difference (Final Values)|4.8||||1|TWO_SIDED|95.0|-8.31|17.91||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||17.91|-8.31|1.00
71136098|NCT01276639|141774005|SUPERIORITY_OR_OTHER||LS mean difference|-15.26|STANDARD_ERROR_OF_MEAN|3.46|<|0.0001|TWO_SIDED|95.0|-22.04|-8.48|||Mixed Models Analysis|||LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-8.48|-22.04|<0.0001
71136099|NCT01276639|141774006|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|34.55|||<|0.0001|TWO_SIDED|95.0|7.46|1786.9||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||1786.9|7.46|<0.0001
71136100|NCT01276639|141774006|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|98.05|||<|0.0001|TWO_SIDED|95.0|23.49|5689.8||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||5689.8|23.49|<0.0001
71136101|NCT01276639|141774006|SUPERIORITY_OR_OTHER||Percent difference|19.61|STANDARD_ERROR_OF_MEAN|3.32|<|0.0001|TWO_SIDED|95.0|13.1|26.11|||Normal approximation|||||26.11|13.10|<0.0001
71136102|NCT01276639|141774008|SUPERIORITY_OR_OTHER||LS mean difference|-3.9|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-4.75|-3.05||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week4: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-3.05|-4.75|<0.0001
71136103|NCT01276639|141774008|SUPERIORITY_OR_OTHER||LS mean difference|-4.71|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-5.56|-3.86||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 4: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-3.86|-5.56|<0.0001
71136104|NCT01276639|141774008|SUPERIORITY_OR_OTHER||LS mean difference|-0.81|STANDARD_ERROR_OF_MEAN|0.35||0.0212|TWO_SIDED|95.0|-1.5|-0.12|||Mixed Models Analysis|||Week 4: LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-0.12|-1.50|0.0212
71136105|NCT01276639|141774008|SUPERIORITY_OR_OTHER||LS mean difference|-4.98|STANDARD_ERROR_OF_MEAN|0.53|<|0.0001|TWO_SIDED|95.0|-6.02|-3.95||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 16: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-3.95|-6.02|<0.0001
70862867|NCT01920555|141212625|SUPERIORITY||Mean Difference (Final Values)|-1.21||||1|TWO_SIDED|95.0|-3.99|1.56||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||1.56|-3.99|1.00
70954395|NCT03568318|141411410|SUPERIORITY||Adjusted Response Rate Difference|49.3|||<|0.001|TWO_SIDED|95.0|34.1|64.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||64.6|34.1|<0.001
70954396|NCT03568318|141411410|SUPERIORITY||Adjusted Response Rate Difference|26.2||||0.002|TWO_SIDED|95.0|9.4|43.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||43.1|9.4|0.002
71136106|NCT01276639|141774008|SUPERIORITY_OR_OTHER||LS mean difference|-6.97|STANDARD_ERROR_OF_MEAN|0.53|<|0.0001|TWO_SIDED|95.0|-8.0|-5.94||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 16: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-5.94|-8.00|<0.0001
71136107|NCT01276639|141774008|SUPERIORITY_OR_OTHER||LS mean difference|-1.99|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-2.8|-1.17|||Mixed Models Analysis|||Week 16: LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-1.17|-2.80|<0.0001
71136108|NCT01276639|141774009|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.34|||<|0.0001|TWO_SIDED|95.0|3.23|35.12||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||35.12|3.23|<0.0001
71136109|NCT01276639|141774009|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.53|||<|0.0001|TWO_SIDED|95.0|5.06|54.42||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||54.42|5.06|<0.0001
71136110|NCT01276639|141774009|SUPERIORITY_OR_OTHER||Percent difference|5.98|STANDARD_ERROR_OF_MEAN|2.97||0.0443|TWO_SIDED|95.0|0.15|11.8|||Normal approximation|||||11.80|0.15|0.0443
71136111|NCT01276639|141774010|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.76||||0.0003|TWO_SIDED|95.0|2.11|35.77||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||35.77|2.11|0.0003
71136112|NCT01276639|141774010|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.55|||<|0.0001|TWO_SIDED|95.0|3.64|59.98||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||59.98|3.64|<0.0001
71136113|NCT01276639|141774010|SUPERIORITY_OR_OTHER||Percent difference|5.09|STANDARD_ERROR_OF_MEAN|2.5||0.0415|TWO_SIDED|95.0|0.19|9.98|||Normal approximation|||||9.98|0.19|0.0415
71136114|NCT01276639|141774011|SUPERIORITY_OR_OTHER||LS mean difference|-69.7|STANDARD_ERROR_OF_MEAN|17.6|<|0.0001|TWO_SIDED|95.0|-104.27|-35.13||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-35.13|-104.27|<0.0001
71136115|NCT01276639|141774011|SUPERIORITY_OR_OTHER||LS mean difference|-97.03|STANDARD_ERROR_OF_MEAN|17.47|<|0.0001|TWO_SIDED|95.0|-131.35|-62.72||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-62.72|-131.35|<0.0001
71136116|NCT01276639|141774011|SUPERIORITY_OR_OTHER||LS mean difference|-27.33|STANDARD_ERROR_OF_MEAN|13.22||0.0391|TWO_SIDED|95.0|-53.29|-1.37|||Mixed Models Analysis|||LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-1.37|-53.29|0.0391
70954397|NCT03568318|141411411|SUPERIORITY||Adjusted Response Rate Difference|41.5|||<|0.001|TWO_SIDED|95.0|27.8|55.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||55.1|27.8|<0.001
70862868|NCT01920555|141212625|SUPERIORITY||Mean Difference (Final Values)|0.76||||0.17|TWO_SIDED|95.0|-1.9|3.43||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||3.43|-1.90|0.17
70862869|NCT01920555|141212625|SUPERIORITY||Mean Difference (Final Values)|-2.74||||0.3|TWO_SIDED|95.0|-5.32|-0.16||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.16|-5.32|0.30
70948041|NCT00267098|141396954|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.01||||0.651|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 18 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 18 month changes in HF Stage were ranked. The BiV - RV difference in average rank was analyzed.|Positive values denote that the BiV arm had better outcomes over time than the RV arm.|Subjects' changes in HF stage from randomization to 18 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.651
70948042|NCT00267098|141396954|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|-0.006||||0.425|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 24 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 24 month changes in HF Stage were ranked. The BiV - RV difference in average rank was analyzed.|Positive values denote better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in HF stage from randomization to 24 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.425
71136117|NCT01276639|141774015|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71136118|NCT01276639|141774015|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71136119|NCT01276639|141774015|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71136120|NCT01276639|141774016|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71136121|NCT01276639|141774016|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71136122|NCT01276639|141774016|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71136123|NCT01276639|141774017|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71136124|NCT01276639|141774017|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71136125|NCT01276639|141774017|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71136126|NCT00330759|141774071|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A synthesis approach was used for a non-inferiority test of the hypothesis that denosumab preserves at least 50% of the effect of zoledronic acid vs. placebo.|Hazard Ratio (HR)|0.84||||0.0007||95.0|0.71|0.98|||Regression, Cox|Stratified by tumor type, previous skeletal-related event, and systematic anti-cancer therapy||||0.98|0.71|0.0007
71136127|NCT00330759|141774072|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.06||95.0|0.71|0.98|||Regression, Cox|P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure.|Stratified by tumor type, previous skeletal-related event, and systematic anti-cancer therapy|||0.98|0.71|0.060
71136128|NCT00330759|141774073|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.145||95.0|0.77|1.04|||Anderson-Gill model|P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure.|Stratified by tumor type, previous skeletal-related event, and systematic anti-cancer therapy|||1.04|0.77|0.145
71136129|NCT03726489|141774080|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|7.2|||<|0.001|TWO_SIDED|95.0|0.8|13.5||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis including all skin phototypes||13.5|0.8|<0.001
71136130|NCT03726489|141774080|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|4.2|||<|0.001|TWO_SIDED|95.0|-5.4|13.8||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||13.8|-5.4|<0.001
71136131|NCT03726489|141774080|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|7.4|||<|0.001|TWO_SIDED|95.0|-2.2|17.0||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||17.0|-2.2|<0.001
71136132|NCT03726489|141774080|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%. The sample size for this subgroup did not meet our a priori sample size required for 80% power.|Risk Difference (RD)|18.7|||<|0.001|TWO_SIDED|95.0|0.8|36.6||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||36.6|0.8|<0.001
71136133|NCT03726489|141774080|OTHER|HTE was assessed using an omnibus Wald test of all interaction regression parameters in order to minimize multiple testing and consequent alpha inflation.||||||0.347||||||HTE was assessed using an omnibus Wald test of all interaction regression parameters in order to minimize multiple testing and consequent alpha inflation.|Regression, Logistic|We fit models for each of the two primary outcomes with skin type, treatment arm, and their interaction as predictors.||Analysis for heterogeneity of treatment effects (HTE) including all skin phototypes.||||0.347
71136134|NCT03726489|141774081|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|18.6|||<|0.001|TWO_SIDED|95.0|11.8|25.3||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis including all skin phototypes||25.3|11.8|<0.001
71136135|NCT03726489|141774081|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|21.2|||<|0.001|TWO_SIDED|95.0|11.0|31.5||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||31.5|11.0|<0.001
71136136|NCT03726489|141774081|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|16.5|||<|0.001|TWO_SIDED|95.0|6.4|26.6||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||26.6|6.4|<0.001
71136137|NCT03726489|141774081|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%. The sample size for this subgroup did not meet our a priori sample size required for 80% power.|Risk Difference (RD)|16.1||||0.001|TWO_SIDED|95.0|-3.7|35.9||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||35.9|-3.7|0.001
71136138|NCT03726489|141774081|OTHER|||||||0.873||||||HTE was assessed using an omnibus Wald test of all interaction regression parameters in order to minimize multiple testing and consequent alpha inflation.|Regression, Logistic|We fit models for each of the two primary outcomes with skin type, treatment arm, and their interaction as predictors.||Analysis for heterogeneity of treatment effects (HTE) including all skin phototypes.||||0.873
71136139|NCT03726489|141774082|SUPERIORITY||Mean Difference (Final Values)|8.7|||<|0.0001|TWO_SIDED|95.0|7.1|10.4||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes||10.4|7.1|<0.0001
71136140|NCT03726489|141774082|SUPERIORITY||Mean Difference (Final Values)|9.38|||<|0.0001|TWO_SIDED|95.0|7.05|11.71||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II||11.71|7.05|<0.0001
71136141|NCT03726489|141774082|SUPERIORITY||Mean Difference (Final Values)|8.48|||<|0.0001|TWO_SIDED|95.0|5.82|11.14||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV||11.14|5.82|<0.0001
71136142|NCT03726489|141774082|SUPERIORITY||Mean Difference (Final Values)|6.82||||0.0213|TWO_SIDED|95.0|1.06|12.58||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI||12.58|1.06|0.0213
71136143|NCT03726489|141774083|SUPERIORITY||Mean Difference (Final Values)|14.6|||<|0.0001|TWO_SIDED|95.0|10.4|18.7||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes||18.7|10.4|<0.0001
71136144|NCT03726489|141774083|SUPERIORITY||Mean Difference (Final Values)|11.47|||<|0.0001|TWO_SIDED|95.0|6.93|16.01||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II||16.01|6.93|<0.0001
71136145|NCT03726489|141774083|SUPERIORITY||Mean Difference (Final Values)|13.87|||<|0.0001|TWO_SIDED|95.0|7.77|19.98||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV||19.98|7.77|<0.0001
70954398|NCT03568318|141411411|SUPERIORITY||Adjusted Response Rate Difference|24.4||||0.001|TWO_SIDED|95.0|10.3|38.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||38.4|10.3|0.001
71136146|NCT03726489|141774083|SUPERIORITY||Mean Difference (Final Values)|32.84||||0.0127|TWO_SIDED|95.0|7.32|58.35||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI||58.35|7.32|0.0127
71136147|NCT03726489|141774084|SUPERIORITY||Mean Difference (Final Values)|-0.81||||0.001|TWO_SIDED|95.0|-1.27|-0.35||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes||-0.35|-1.27|0.001
70862870|NCT01920555|141212625|SUPERIORITY||Mean Difference (Final Values)|-0.71||||1|TWO_SIDED|95.0|-3.35|1.93||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||1.93|-3.35|1.00
71136148|NCT03726489|141774084|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.0158|TWO_SIDED|95.0|-1.51|-0.16||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II||-0.16|-1.51|0.0158
71136149|NCT03726489|141774084|SUPERIORITY||Mean Difference (Final Values)|-0.88||||0.013|TWO_SIDED|95.0|-1.58|-0.19||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV||-0.19|-1.58|0.0130
71136150|NCT03726489|141774084|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.591|TWO_SIDED|95.0|-1.94|1.11||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI||1.11|-1.94|0.5910
71136151|NCT03726489|141774084|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.395|TWO_SIDED|95.0|-0.33|0.82||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes at Week 24||0.82|-0.33|0.395
71136152|NCT03726489|141774084|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.774|TWO_SIDED|95.0|-0.69|0.93||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II at Week 24||0.93|-0.69|0.774
71136153|NCT03726489|141774084|SUPERIORITY||Median Difference (Final Values)|0.53||||0.242|TWO_SIDED|95.0|-0.36|1.41||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV at Week 24||1.41|-0.36|0.242
71136154|NCT03726489|141774084|SUPERIORITY||Mean Difference (Final Values)|-0.44||||0.692|TWO_SIDED|95.0|-2.72|1.83||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI at Week 24||1.83|-2.72|0.692
71136155|NCT03726489|141774085|SUPERIORITY||Risk Difference (RD)|-2.59||||0.1209|TWO_SIDED|95.0|-5.86|0.68||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes - Initiation||0.68|-5.86|0.1209
71136156|NCT03726489|141774085|SUPERIORITY||Risk Difference (RD)|-2.13||||0.2581|TWO_SIDED|95.0|-6.0|1.75||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II - Initiation||1.75|-6.0|0.2581
71136157|NCT03726489|141774085|SUPERIORITY||Risk Difference (RD)|-3.04||||0.2952|TWO_SIDED|95.0|-8.73|2.65||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV - Initiation||2.65|-8.73|0.2952
71136158|NCT03726489|141774085|SUPERIORITY||Risk Difference (RD)|-2.61||||0.6324|TWO_SIDED|95.0|-13.12|7.89||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI - Initiation||7.89|-13.12|0.6324
71136159|NCT03726489|141774085|SUPERIORITY||Risk Difference (RD)|0.15||||0.9163|TWO_SIDED|95.0|-2.56|2.85||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes - Discontinuation||2.85|-2.56|0.9163
71136160|NCT03726489|141774085|SUPERIORITY||Risk Difference (RD)|0.31||||0.8551|TWO_SIDED|95.0|-3.03|3.66||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II - Discontinuation||3.66|-3.03|0.8551
71136161|NCT03726489|141774085|SUPERIORITY||Risk Difference (RD)|0.72||||0.7678|TWO_SIDED|95.0|-4.05|5.48||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV - Discontinuation||5.48|-4.05|0.7678
71136162|NCT03726489|141774085|SUPERIORITY||Risk Difference (RD)|-3.03||||0.3446|TWO_SIDED|95.0|-8.88|2.82||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI - Discontinuation||2.82|-8.88|0.3446
71136163|NCT03726489|141774085|SUPERIORITY||Risk Difference (RD)|-1.26||||0.5716|TWO_SIDED|95.0|-5.64|3.11||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes - Initiation at Week 24||3.11|-5.64|0.5716
71136164|NCT03726489|141774085|SUPERIORITY||Risk Difference (RD)|-0.44||||0.8756|TWO_SIDED|95.0|-6.03|5.14||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II - Initiation at Week 24||5.14|-6.03|0.8756
71136165|NCT03726489|141774085|SUPERIORITY||Risk Difference (RD)|-2.07||||0.5686|TWO_SIDED|95.0|-9.18|5.04||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV - Initiation at Week 24||5.04|-9.18|0.5686
71136166|NCT03726489|141774085|SUPERIORITY||Risk Difference (RD)|-1.39||||0.866|TWO_SIDED|95.0|-17.5|14.7||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI - Initiation at Week 24||14.7|-17.5|0.8660
71136167|NCT03726489|141774085|SUPERIORITY||Risk Difference (RD)|0.19||||0.8779|TWO_SIDED|95.0|-2.24|2.62||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes - Discontinuation at Week 24||2.62|-2.24|0.8779
71136168|NCT03726489|141774085|SUPERIORITY||Risk Difference (RD)|0.38||||0.7985|TWO_SIDED|95.0|-2.52|3.28||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II - Discontinuation at Week 24||3.28|-2.52|0.7985
71136169|NCT03726489|141774085|SUPERIORITY||Risk Difference (RD)|0.69||||0.7585|TWO_SIDED|95.0|-3.71|5.09||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV - Discontinuation at Week 24||5.09|-3.71|0.7585
71136170|NCT03726489|141774085|SUPERIORITY||Risk Difference (RD)|-2.78||||0.3422|TWO_SIDED|95.0|-8.15|2.59||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI - Discontinuation at Week 24||2.59|-8.15|0.3422
71136171|NCT03726489|141774086|SUPERIORITY||Mean Difference (Final Values)|-3.2||||0.094|TWO_SIDED|95.0|-6.95|0.55||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes||0.55|-6.95|0.094
71136172|NCT03726489|141774086|SUPERIORITY||Mean Difference (Final Values)|-5.26||||0.0393|TWO_SIDED|95.0|-10.26|-0.26||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II||-0.26|-10.26|0.0393
71136173|NCT03726489|141774086|SUPERIORITY||Mean Difference (Final Values)|-3.92||||0.1505|TWO_SIDED|95.0|-9.28|1.44||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV||1.44|-9.28|0.1505
71136174|NCT03726489|141774086|SUPERIORITY||Mean Difference (Final Values)|10.42||||0.284|TWO_SIDED|95.0|-9.0|29.84||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI||29.84|-9.0|0.2840
71136175|NCT03726489|141774087|OTHER||Mean|19.87|STANDARD_DEVIATION|61.6|||TWO_SIDED|||||P-value is not applicable.||||Overall analysis adjusted for all skin phototypes||||
71136176|NCT03726489|141774087|OTHER||Mean|18.06|STANDARD_DEVIATION|57.04|||TWO_SIDED|||||P-value is not applicable.||||Analysis for Phototypes I/II||||
71136177|NCT03726489|141774087|OTHER||Mean|23.46|STANDARD_DEVIATION|70.71|||TWO_SIDED|||||P-value is not applicable.||||Analysis for Phototypes III/IV||||
71136178|NCT03726489|141774087|OTHER||Mean|9.22|STANDARD_DEVIATION|5.66|||TWO_SIDED|||||P-value is not applicable.||||Analysis for Phototypes V/VI||||
71136179|NCT03726489|141774088|OTHER||Mean|50.3|STANDARD_DEVIATION|46.7|||TWO_SIDED|||||P-value is not applicable.||||Overall analysis adjusted for all skin phototypes||||
71136180|NCT03726489|141774088|OTHER||Mean|53.19|STANDARD_DEVIATION|50.05|||TWO_SIDED|||||P-value is not applicable.||||Analysis for Phototypes I/II||||
71136181|NCT03726489|141774088|OTHER||Mean|49.82|STANDARD_DEVIATION|47.43|||TWO_SIDED|||||P-value is not applicable.||||Analysis for Phototypes III/IV||||
71136182|NCT03726489|141774088|OTHER||Mean|39.72|STANDARD_DEVIATION|20.47|||TWO_SIDED|||||P-value is not applicable.||||Analysis for Phototypes V/VI||||
71136183|NCT03726489|141774089|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|11.97|||<|0.0001|TWO_SIDED|95.0|6.52|17.42||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes||17.42|6.52|<0.0001
71136184|NCT03726489|141774089|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|16.15|||<|0.0001|TWO_SIDED|95.0|7.54|24.75||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||24.75|7.54|<0.0001
71136185|NCT03726489|141774089|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|5.56|||<|0.0001|TWO_SIDED|95.0|-2.35|13.46||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||13.46|-2.35|<0.0001
71136186|NCT03726489|141774089|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|21.37|||<|0.0001|TWO_SIDED|95.0|7.65|35.09||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||35.09|7.65|<0.0001
71136187|NCT03726489|141774090|SUPERIORITY||Risk Difference (RD)|11.68||||0.0065|TWO_SIDED|95.0|3.27|20.08||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes||20.08|3.27|0.0065
71136188|NCT03726489|141774090|SUPERIORITY||Risk Difference (RD)|12.31||||0.0478|TWO_SIDED|95.0|0.03|24.49||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||24.49|0.03|0.0478
71136189|NCT03726489|141774090|SUPERIORITY||Risk Difference (RD)|13.25||||0.0431|TWO_SIDED|95.0|0.52|25.98||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||25.98|0.52|0.0431
71136190|NCT03726489|141774090|SUPERIORITY||Risk Difference (RD)|1.5||||0.9133|TWO_SIDED|95.0|-25.5|28.5||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||28.50|-25.50|0.9133
71136191|NCT03726489|141774091|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.048|TWO_SIDED|95.0|-15.73|-0.07||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes||-0.07|-15.73|0.048
71136192|NCT03726489|141774091|SUPERIORITY||Mean Difference (Final Values)|-10.67||||0.1199|TWO_SIDED|95.0|-24.15|2.8||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II||2.80|-24.15|0.1199
71136193|NCT03726489|141774091|SUPERIORITY||Mean Difference (Final Values)|-5.3||||0.2953|TWO_SIDED|95.0|-15.26|4.66||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV||4.66|-15.26|0.2953
71136194|NCT03726489|141774091|SUPERIORITY||Mean Difference (Final Values)|-8.83||||0.5124|TWO_SIDED|95.0|-35.77|18.11||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI||18.11|-35.77|0.5124
71136195|NCT03726489|141774092|SUPERIORITY||Risk Difference (RD)|10.9||||0.0173|TWO_SIDED|95.0|1.93|19.87||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes||19.87|1.93|0.0173
71136196|NCT03726489|141774092|SUPERIORITY||Risk Difference (RD)|13.06||||0.0662|TWO_SIDED|95.0|-0.81|26.94||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||26.94|-0.81|0.0662
71136197|NCT03726489|141774092|SUPERIORITY||Risk Difference (RD)|8.58||||0.1976|TWO_SIDED|95.0|-4.42|21.57||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||21.57|-4.42|0.1976
71136198|NCT03726489|141774092|SUPERIORITY||Risk Difference (RD)|13.04||||0.3595|TWO_SIDED|95.0|-14.6|40.69||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||40.69|-14.60|0.3595
71136199|NCT03726489|141774093|SUPERIORITY||Risk Difference (RD)|7.55||||0.0853|TWO_SIDED|95.0|-1.05|16.14||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes||16.14|-1.05|0.0853
71136200|NCT03726489|141774093|SUPERIORITY||Risk Difference (RD)|2.26||||0.7488|TWO_SIDED|95.0|-11.54|16.06||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||16.06|-11.54|0.7488
71136201|NCT03726489|141774093|SUPERIORITY||Risk Difference (RD)|10.12||||0.1051|TWO_SIDED|95.0|-2.03|22.26||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||22.26|-2.03|0.1051
71136202|NCT03726489|141774093|SUPERIORITY||Risk Difference (RD)|17.39||||0.1792|TWO_SIDED|95.0|-7.48|42.27||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||42.27|-7.48|0.1792
71136203|NCT03726489|141774094|SUPERIORITY||Mean Difference (Final Values)|3.07||||0.175|TWO_SIDED|95.0|-1.37|7.5||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes||7.50|-1.37|0.175
71136204|NCT03726489|141774094|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.8904|TWO_SIDED|95.0|-6.34|5.51||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II||5.51|-6.34|0.8904
71136205|NCT03726489|141774094|SUPERIORITY||Mean Difference (Final Values)|7.59||||0.0412|TWO_SIDED|95.0|0.31|14.88||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV||14.88|0.31|0.0412
70954399|NCT03568318|141411412|SUPERIORITY||Adjusted Response Rate Difference|34.9|||<|0.001|TWO_SIDED|95.0|20.6|49.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||49.3|20.6|<0.001
71136206|NCT03726489|141774094|SUPERIORITY||Mean Difference (Final Values)|5.5||||0.5481|TWO_SIDED|95.0|-13.38|24.38||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI||24.38|-13.38|0.5481
71136207|NCT03726489|141774094|SUPERIORITY||Hazard Ratio (HR)|0.813||||0.458|TWO_SIDED|95.0|0.471|1.403|||Regression, Cox|Failure event corresponds to DLQI assessment greater than 5. Model adjusted for skin phototype.|Office phototherapy is the reference group.|Cox proportional hazards model for maintaining treatment response after week 12.||1.403|0.471|0.458
70954400|NCT03568318|141411412|SUPERIORITY||Adjusted Response Rate Difference|24.5||||0.001|TWO_SIDED|95.0|10.4|38.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||38.7|10.4|0.001
70948043|NCT00267098|141396958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7||||0.9976|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Probability of Mean QOL Change|The posterior distribution for the BiV - RV difference in mean QOL score improvement from randomization to 6 months was determined.||"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in QOL score from randomization to 6 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a greater reduction (and thus improvement) in QOL score at 6 months than patients with right ventricular pacing."||||0.9976
71136208|NCT03726489|141774095|SUPERIORITY||Risk Difference (RD)|38.1|||<|0.0001|TWO_SIDED|95.0|30.34|45.86||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes||45.86|30.34|<0.0001
71136209|NCT03726489|141774095|SUPERIORITY||Risk Difference (RD)|38.86|||<|0.0001|TWO_SIDED|95.0|27.39|50.33||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||50.33|27.39|<0.0001
71136210|NCT03726489|141774095|SUPERIORITY||Risk Difference (RD)|42.21|||<|0.0001|TWO_SIDED|95.0|30.73|53.68||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||53.68|30.73|<0.0001
71136211|NCT03726489|141774095|SUPERIORITY||Risk Difference (RD)|15.74||||0.234|TWO_SIDED|95.0|-9.63|41.11||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||41.11|-9.63|0.2340
71136212|NCT03726489|141774096|SUPERIORITY||Risk Difference (RD)|43.96|||<|0.0001|TWO_SIDED|95.0|37.25|50.66||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis including all skin phototypes||50.66|37.25|<0.0001
71136213|NCT03726489|141774096|SUPERIORITY||Risk Difference (RD)|39.85|||<|0.0001|TWO_SIDED|95.0|30.0|49.7||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||49.70|30.0|<0.0001
71136214|NCT03726489|141774096|SUPERIORITY||Risk Difference (RD)|50.18|||<|0.0001|TWO_SIDED|95.0|40.09|60.27||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||60.27|40.09|<0.0001
71136215|NCT03726489|141774096|SUPERIORITY||Risk Difference (RD)|36.11|||<|0.0001|TWO_SIDED|95.0|14.35|57.87||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||57.87|14.35|<0.0001
71136216|NCT03726489|141774097|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|-5.2||||0.1773|TWO_SIDED|95.0|-19.4|9.0||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis including all skin phototypes||9.0|-19.4|0.1773
71136217|NCT03726489|141774097|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|-6.88||||0.4073|TWO_SIDED|95.0|-26.09|12.33||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||12.33|-26.09|0.4073
71136218|NCT03726489|141774097|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|-12.42||||0.8247|TWO_SIDED|95.0|-35.24|10.41||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||10.41|-35.24|0.8247
71136219|NCT03726489|141774097|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|37.88||||0.0133|TWO_SIDED|95.0|-4.01|79.77||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||79.77|-4.01|0.0133
71136220|NCT03726489|141774098|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|6.52||||0.002|TWO_SIDED|95.0|-7.11|20.14||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis including all skin phototypes||20.14|-7.11|0.002
71136221|NCT03726489|141774098|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|7.77||||0.0137|TWO_SIDED|95.0|-10.35|25.89||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||25.89|-10.35|0.0137
71136222|NCT03726489|141774098|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|1.0||||0.1656|TWO_SIDED|95.0|-21.61|23.61||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||23.61|-21.61|0.1656
70862871|NCT01920555|141212625|SUPERIORITY||Mean Difference (Final Values)|-0.29||||1|TWO_SIDED|95.0|-3.25|2.66||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||2.66|-3.25|1.00
71136223|NCT03726489|141774098|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|22.73||||0.1225|TWO_SIDED|95.0|-25.16|70.62||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||70.62|-25.16|0.1225
71136224|NCT03726489|141774099|SUPERIORITY||Risk Difference (RD)|0.105||||0.0183|TWO_SIDED|95.0|0.018|0.192|||Marginal contrast||Positive values indicate higher proportion in the home group.|Difference of proportion at week 16. Calculated using contrasts of predictive margins following logistic regression with robust variance estimators via generalized estimating equations and exchangeable correlation. Missing data for DLQI are imputed using multiple imputation via chained equations (10 imputations), and the estimates are combined using standard rules.||0.192|0.018|0.0183
71136225|NCT03726489|141774099|SUPERIORITY||Risk Difference (RD)|0.064||||0.177|TWO_SIDED|95.0|-0.029|0.158|||Marginal contrast||Positive values indicate higher proportion in the home group.|Difference of proportion at week 20. Calculated using contrasts of predictive margins following logistic regression with robust variance estimators via generalized estimating equations and exchangeable correlation. Missing data for DLQI are imputed using multiple imputation via chained equations (10 imputations), and the estimates are combined using standard rules.||0.158|-0.029|0.177
71136226|NCT03726489|141774099|SUPERIORITY||Risk Difference (RD)|-0.011||||0.815|TWO_SIDED|95.0|-0.101|0.079|||Marginal contrast||Positive values indicate higher proportion in the home group.|Difference of proportion at week 24. Calculated using contrasts of predictive margins following logistic regression with robust variance estimators via generalized estimating equations and exchangeable correlation. Missing data for DLQI are imputed using multiple imputation via chained equations (10 imputations), and the estimates are combined using standard rules.||0.079|-0.101|0.815
71136227|NCT04057807|141774108|SUPERIORITY|||||||0.14|||||||unpaired t-tests (continuous variables)|||||||0.14
70862872|NCT01920555|141212625|SUPERIORITY||Mean Difference (Final Values)|2.76||||0.39|TWO_SIDED|95.0|-0.06|5.59||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||5.59|-0.06|0.39
70862873|NCT01920555|141212625|SUPERIORITY||Mean Difference (Final Values)|-1.17||||1|TWO_SIDED|95.0|-3.91|1.58||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||1.58|-3.91|1.00
70862874|NCT01920555|141212625|SUPERIORITY||Mean Difference (Final Values)|-0.43||||1|TWO_SIDED|95.0|-3.22|2.35||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||2.35|-3.22|1.00
70862875|NCT00195273|141212644|SUPERIORITY_OR_OTHER|||||||0.6081||||||Calculated for 12 month analysis|ANOVA|Analysis of variance with treatment group and center as factors||||||0.6081
70862876|NCT00195273|141212647|SUPERIORITY_OR_OTHER|||||||0.4662|||||||ANOVA|Calculated for 3 month analysis||||||0.4662
70862877|NCT02186873|141212651|SUPERIORITY_OR_OTHER||Difference in Percentage|47.1|||<|0.001|TWO_SIDED|95.0|35.18|58.99|||Cochran-Mantel-Haenszel|||||58.99|35.18|<0.001
70862878|NCT02595970|141212660|SUPERIORITY|adjusted for multiplicity using the Hochberg procedure.|Mean Difference (Net)|-22.6|STANDARD_ERROR_OF_MEAN|0.99|<|0.0001|TWO_SIDED|95.0|-24.52|20.59|||t-test, 2 sided|||||20.59|-24.52|<0.0001
70862879|NCT02595970|141212670|SUPERIORITY|adjusted|Mean Difference (Net)|-21.6|STANDARD_ERROR_OF_MEAN|0.99|<|0.0001|TWO_SIDED|95.0|-23.52|19.58|||t-test, 2 sided|||||19.58|-23.52|<0.0001
70862880|NCT01886716|141212676|SUPERIORITY_OR_OTHER||Slope|-0.8|STANDARD_ERROR_OF_MEAN|0.95|=|0.4|TWO_SIDED||||||Mixed Models Analysis||F(1,517) = .71|"The analyses used multilevel modeling to capture both the trajectories of symptoms within individuals (i.e., level 1) and the hypothesized between-subject moderators of these trajectories, alcohol and anxiety attention training (i.e., level 2) across all 7 time points.~Note, although all 4 groups are included in this analysis, this analysis specifically compares anxiety vs. control training."||||=.40
71136228|NCT04057807|141774109|SUPERIORITY|||||||0.82|||||||univariate linear regression analysis|two-tailed P value was obtained from a univariate linear regression analysis||||||0.82
71136229|NCT00786799|141774113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.3|STANDARD_DEVIATION|6.1||0.4|||||||t-test, 2 sided|||The null hypothesis is that the mean change in Aberrant Behavior Checklist Hyperactivity subscale (ABC-H) score is the same for both groups.||||0.40
71136230|NCT01072188|141774160|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71136231|NCT01072188|141774161|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71136232|NCT03956550|141774184|SUPERIORITY|||||||0.2978|||||||Mixed Models Analysis|||||||0.2978
71136233|NCT03956550|141774184|SUPERIORITY|||||||0.689|||||||Mixed Models Analysis|||||||0.6890
71136234|NCT03956550|141774185|SUPERIORITY|||||||0.1973|||||||Mixed Models Analysis|||||||0.1973
71136235|NCT03956550|141774185|SUPERIORITY|||||||0.942|||||||Mixed Models Analysis|||||||0.9420
70948044|NCT00267098|141396959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||0.9641|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Probability of Mean QOL Change|The posterior distribution for the BiV - RV difference in mean QOL score improvement from randomization to 12 months was determined.||"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in QOL score from randomization to 12 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a greater reduction (and thus improvement) in QOL score at 12 months than patients with right ventricular pacing."||||0.9641
70954401|NCT03568318|141411413|SUPERIORITY||Adjusted Response Rate Difference|19.8||||0.001|TWO_SIDED|95.0|7.8|31.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||31.8|7.8|0.001
71136236|NCT03956550|141774186|SUPERIORITY|||||||0.1597|||||||Mixed Models Analysis|||||||0.1597
71136237|NCT03956550|141774186|SUPERIORITY|||||||0.9719|||||||Mixed Models Analysis|||||||0.9719
71136238|NCT03956550|141774187|SUPERIORITY|||||||0.1365|||||||Mixed Models Analysis|||||||0.1365
71136239|NCT03956550|141774187|SUPERIORITY|||||||0.0604|||||||Mixed Models Analysis|||||||0.0604
70954402|NCT03568318|141411414|SUPERIORITY||Adjusted Response Rate Difference|6.2||||0.306|TWO_SIDED|95.0|-5.7|18.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||18.2|-5.7|0.306
71136240|NCT03956550|141774188|SUPERIORITY|||||||0.0989|||||||Mixed Models Analysis|||||||0.0989
71136241|NCT03956550|141774188|SUPERIORITY|||||||0.5487|||||||Mixed Models Analysis|||||||0.5487
71136242|NCT03956550|141774189|SUPERIORITY|||||||0.3572|||||||Cochran-Mantel-Haenszel|||||||0.3572
71136243|NCT03956550|141774189|SUPERIORITY|||||||0.5747|||||||Cochran-Mantel-Haenszel|||||||0.5747
71136244|NCT00896298|141774203|SUPERIORITY|||||||0.2572|||||||Mixed Models Analysis|||||||0.2572
71136245|NCT00896298|141774204|SUPERIORITY|||||||0.71|||||||Mixed Models Analysis|||||||0.71
70954403|NCT03568318|141411414|SUPERIORITY||Adjusted Response Rate Difference|-1.0||||0.855|TWO_SIDED|95.0|-11.2|9.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||9.3|-11.2|0.855
71136246|NCT00896298|141774205|SUPERIORITY|||||||0.68|||||||Mixed Models Analysis|||||||0.68
71136247|NCT00896298|141774206|SUPERIORITY|||||||0.0256|||||||Mixed Models Analysis|||||||0.0256
71136248|NCT00287222|141774207|SUPERIORITY_OR_OTHER||percentage progression free at 27 weeks|28.0|STANDARD_ERROR_OF_MEAN|10.97||0.0006|TWO_SIDED|95.0|10.0|53.0|||one-sided exact binomial test|||Estimating the percentage of participants that remain free of disease progression at 27 weeks from the onset of treatment, and testing that proportion against a null-hypothesis proportion of 0.04 using the one-sided exact binomial test at 5% alpha, based upon historical data from the literature.||53|10|0.0006
71136249|NCT00824473|141774208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4286|STANDARD_ERROR_OF_MEAN|0.351|<|0.001||95.0|-2.12|-0.74|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Overall change from baseline||-0.74|-2.12|<0.001
71136250|NCT00824473|141774209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6063|STANDARD_ERROR_OF_MEAN|0.1697|<|0.001||95.0|-0.94|-0.27|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.27|-0.94|<0.001
71136251|NCT00824473|141774210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3947|STANDARD_ERROR_OF_MEAN|0.3391|<|0.001||95.0|-2.06|-0.73|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Overall change from baseline||-0.73|-2.06|<0.001
71136252|NCT00824473|141774211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9284|STANDARD_ERROR_OF_MEAN|0.2741|<|0.001||95.0|-1.47|-0.39|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||reflective TOSS change in baseline||-0.39|-1.47|<0.001
71136253|NCT00824473|141774212|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||change from baseline||||0.010
71136254|NCT01359904|141774214|SUPERIORITY_OR_OTHER|||||||0.027|||||||Chi-squared|||||||0.027
71136255|NCT01359904|141774215|SUPERIORITY_OR_OTHER|||||||0.67|||||||Kruskal-Wallis|||post intervention hemoglobin A1c levels||||0.67
71136256|NCT01359904|141774216|SUPERIORITY_OR_OTHER|||||||0.2|||||||Kruskal-Wallis|||||||0.20
71136257|NCT01359904|141774217|SUPERIORITY_OR_OTHER|||||||0.32|||||||Chi-squared|||||||0.32
71136258|NCT02660853|141774218|SUPERIORITY|||||||0.745|||||||t-test, 2 sided|||Baseline versus during exacerbation.||||0.745
71136259|NCT02660853|141774222|SUPERIORITY|||||||0.326|||||||t-test, 2 sided|||||||0.326
71136260|NCT03369418|141774249|SUPERIORITY|One tailed t-tests for independent groups were performed to test the hypothesis that active device will be superior to sham in decreasing the combined HAD score. This was accomplished by Contrast analysis within the framework of a random effects general linear mixed effects (RE GLMM) model.||||||0.013||||||A priori threshold for statistical significance was p\<.05.|t-test, 1 sided|||||||.013
71136261|NCT03369418|141774250|SUPERIORITY|||||||0.33|||||||t-test, 1 sided|||||||.33
71136262|NCT00796666|141774256|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8616||||0.5416|TWO_SIDED|95.0|0.602|1.233|||Log Rank|||||1.233|0.602|0.5416
71136263|NCT00796666|141774257|SUPERIORITY_OR_OTHER|||||||0.0049|TWO_SIDED|||||P-value was based on the analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO Functional Class (FC) as fixed effects and baseline 6 Minute Walk Distance (6MWD) as a covariate.|ANCOVA|||Baseline to Week 12||||0.0049
71136264|NCT00796666|141774258|SUPERIORITY_OR_OTHER|||||||0.8223|TWO_SIDED|||||Missing values at Week 12 and Week 24 were imputed with the last non-missing WHO FC based on the last observation carried forward (LOCF) method.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test used modified ridit scores and the p-value corresponding to the ANCOVA (row mean scores) statistic was reported.||Baseline to Week 12||||0.8223
71136265|NCT00796666|141774259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|95.0|-3.13|1.2|||||Least squared (LS) mean and p-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Physical Functioning Score as a covariate.|Baseline to Week 12||1.20|-3.13|
71136266|NCT00796666|141774259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.33|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|95.0|0.31|4.36|||||Least squared (LS) mean and p-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Physical Functioning Score as a covariate.|Baseline to Week 12||4.36|0.31|
71136267|NCT00796666|141774259|SUPERIORITY_OR_OTHER|||||||0.0094|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Physical Functioning Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.0094
71136268|NCT00796666|141774260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|95.0|-3.92|1.2|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitations Due to Physical Health Problems Score as a covariate.|Baseline to Week 12||1.20|-3.92|
71136269|NCT00796666|141774260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.99|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|95.0|-0.38|4.35|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitations Due to Physical Health Problems Score as a covariate.|Baseline to Week 12||4.35|-0.38|
71136270|NCT00796666|141774260|SUPERIORITY_OR_OTHER|||||||0.0244|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitations Due to Physical Health Problems Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.0244
71136271|NCT00796666|141774261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|95.0|-3.78|2.04|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Bodily Pain Score as a covariate.|Baseline to Week 12||2.04|-3.78|
71136272|NCT00796666|141774261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.24|STANDARD_ERROR_OF_MEAN|1.34|||TWO_SIDED|95.0|-0.41|4.9|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Bodily Pain Score as a covariate.|Baseline to Week 12||4.90|-0.41|
71136273|NCT00796666|141774261|SUPERIORITY_OR_OTHER|||||||0.0624|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Bodily Pain Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.0624
71136274|NCT00796666|141774262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|1.17|||TWO_SIDED|95.0|-2.57|2.06|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FCvas fixed effects and baseline General Health Score as a covariate.|Baseline to Week 12||2.06|-2.57|
71136275|NCT00796666|141774262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.65|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|95.0|0.48|4.82|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline General Health Score as a covariate.|Baseline to Week 12||4.82|0.48|
71136276|NCT00796666|141774262|SUPERIORITY_OR_OTHER|||||||0.0324|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline General Health Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.0324
71136277|NCT00796666|141774263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|1.28|||TWO_SIDED|95.0|-2.1|2.97|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Vitality Score as a covariate.|Baseline to Week 12||2.97|-2.10|
71136278|NCT00796666|141774263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.09|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|95.0|1.74|6.45|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Vitality Score as a covariate.|Baseline to Week 12||6.45|1.74|
71136279|NCT00796666|141774263|SUPERIORITY_OR_OTHER|||||||0.0136|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Vitality Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.0136
71136280|NCT00796666|141774264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|-2.33|3.23|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Social Functioning Score as a covariate.|Baseline to Week 12||3.23|-2.33|
71136281|NCT00796666|141774264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.73|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|95.0|0.14|5.32|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Social Functioning Score as a covariate.|Baseline to Week 12||5.32|0.14|
71136282|NCT00796666|141774264|SUPERIORITY_OR_OTHER|||||||0.1582|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Social Functioning Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.1582
71136283|NCT00796666|141774265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|1.58|||TWO_SIDED|95.0|-3.09|3.18|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitation Due to Emotional Problems Score as a covariate.|Baseline to Week 12||3.18|-3.09|
71136284|NCT00796666|141774265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.27|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|95.0|-0.62|5.16|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitation Due to Emotional Problems Score as a covariate.|Baseline to Week 12||5.16|-0.62|
71136285|NCT00796666|141774265|SUPERIORITY_OR_OTHER|||||||0.2161|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitation Due to Emotional Problems Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.2161
70954404|NCT03568318|141411415|SUPERIORITY||LS Mean Difference|-16.05|STANDARD_ERROR_OF_MEAN|11.956||0.18|TWO_SIDED|95.0|-39.59|7.48|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||7.48|-39.59|0.180
71136286|NCT00796666|141774266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44|STANDARD_ERROR_OF_MEAN|1.54|||TWO_SIDED|95.0|-1.61|4.5|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Mental Health Score as a covariate.|Baseline to Week 12||4.50|-1.61|
71136287|NCT00796666|141774266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.66|STANDARD_ERROR_OF_MEAN|1.43|||TWO_SIDED|95.0|0.82|6.5|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Mental Health Score as a covariate.|Baseline to Week 12||6.50|0.82|
71136288|NCT00796666|141774266|SUPERIORITY_OR_OTHER|||||||0.2087|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Mental Health Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.2087
71136289|NCT00796666|141774267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.18|STANDARD_ERROR_OF_MEAN|1.21|||TWO_SIDED|95.0|-1.21|3.58|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Mental Health Score as a covariate.|Baseline to Week 12||3.58|-1.21|
71136290|NCT00796666|141774267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.71|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|95.0|0.37|5.05|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Mental Health Score as a covariate.|Baseline to Week 12||5.05|0.37|
70954405|NCT03568318|141411415|SUPERIORITY||LS Mean Difference|-26.38|STANDARD_ERROR_OF_MEAN|11.986||0.029|TWO_SIDED|95.0|-49.97|-2.79|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-2.79|-49.97|0.029
71136291|NCT00796666|141774267|SUPERIORITY_OR_OTHER|||||||0.2897|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Mental Health Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.2897
71136292|NCT00796666|141774268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|95.0|-2.05|1.38|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Physical Health Score as a covariate.|Baseline to Week 12||1.38|-2.05|
71136293|NCT00796666|141774268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.14|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|95.0|0.46|3.82|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Physical Health Score as a covariate.|Baseline to Week 12||3.82|0.46|
71136294|NCT00796666|141774268|SUPERIORITY_OR_OTHER|||||||0.0179|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Physical Health Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.0179
71136295|NCT01521507|141774275|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Stage 1 primary and secondary outcomes were tested in order under a closed form testing method. Secondary outcome was tested only if primary outcome was statistically significant. If both outcomes were significant, overall study alpha was 0.025.|z-statistic|p-value was based on z-statistic of the sum of weighted average of difference in scores between groups at each site divided by the sum of the weights.||The null and alternative hypotheses are H0: µt ≤ µc vs. Ha: µt \> µc, where µt and µc are the mean changes in total meibomian gland scores from Baseline to 3 Months for the LipiFlow (test) and Warm Compress and Lid Hygiene (active control) groups, respectively. For the Stage 1 Primary Outcome, the minimum sample size was 24 subjects per group with a power of 90% and a one-sided alpha of 0.025.||||<0.0001
71136296|NCT01521507|141774275|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Mixed Models Analysis|||Supportive multivariate mixed model was also performed for this outcome controlling for significant demographic and baseline characteristics.||||0.0020
71136297|NCT01521507|141774276|SUPERIORITY_OR_OTHER|||||||0.9098|TWO_SIDED||||||Mixed Models Analysis|Stage 2 Primary Outcome was analyzed with a multivariate mixed model with the subgroup as a fixed effect while controlling for other covariates.||The null and alternative hypotheses for the Stage 2 Primary Outcome was: H0: µi= µj for all i and j where i≠j versus Ha: µi ≠ µj for at least one i and j, where µi is the mean total meibomian gland score at 12 Months for the ith subgroup. The null hypothesis was tested with a two-sided test at alpha=0.05. Since Stage 2 was an observational design, no minimum sample size was calculated for Stage 2.||||0.9098
71136298|NCT01521507|141774277|SUPERIORITY_OR_OTHER|||||||0.0068|TWO_SIDED|||||Stage 1 primary and secondary outcomes were tested in order under a closed form testing method. Secondary outcome was tested only if primary outcome was statistically significant. If both outcomes were significant, overall study alpha was 0.025.|t-test, 2 sided|||The null and alternative hypotheses are H0: µt ≤ µc vs. Ha: µt \> µc, where µt and µc are the mean changes in total OSDI scores from Baseline to 3 Months for the LipiFlow (test) and Warm Compress and Lid Hygiene (active control) groups, respectively. For the Stage 1 Secondary Outcome, the minimum sample size was 84 per group with a power of 80% and a one-sided alpha of 0.025.||||0.0068
71136299|NCT01521507|141774277|SUPERIORITY_OR_OTHER|||||||0.0419|TWO_SIDED||||||Mixed Models Analysis|||Supportive multivariate mixed model was also performed for this outcome controlling for significant demographic and baseline characteristics.||||0.0419
71136300|NCT01521507|141774278|SUPERIORITY_OR_OTHER|||||||0.0237|TWO_SIDED|||||Stage 2 Secondary Outcome was analyzed with a multivariate mixed model with the subgroup as a fixed effect while controlling for other covariates.|Mixed Models Analysis|||The null and alternative hypotheses for the Stage 2 Secondary Outcome was: H0: µi= µj for all i and j where i≠j versus Ha: µi ≠ µj for at least one i and j, where µi is the mean total OSDI score at 12 Months for the ith subgroup. The null hypothesis was tested with a two-sided test at alpha=0.05. Since Stage 2 was an observational design, no minimum sample size was calculated for Stage 2.||||0.0237
71136301|NCT01292187|141774291|SUPERIORITY_OR_OTHER|||||||0.0265|||||||Mixed Models Analysis|||||||0.0265
71136302|NCT01292187|141774292|SUPERIORITY_OR_OTHER|||||||0.034|||||||Mixed Models Analysis|||||||0.0340
71136303|NCT00113841|141774301|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||t-test, 2 sided|||||||0.16
71136304|NCT00430716|141774321|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|24.15||||0.011|ONE_SIDED|97.5|3.37||||ANOVA|||An analysis of variance (ANOVA) model followed by the Williams trend test (one-sided, at the 2.5% level of significance) was used. The Williams trend test firstly determined if there was a significant downward trend in response for the descending doses, and then subsequently determined the highest dose that was statistically inferior to 20 mg (known to be an effective dose of sildenafil). A corresponding 97.5% lower confidence limit for the difference was presented.|||3.37|0.011
71136305|NCT00430716|141774321|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.17||||0.545|ONE_SIDED|97.5|-21.48||||ANOVA|||ANOVA model followed by the Williams trend test (one-sided, at the 2.5% level of significance) was used. The Williams trend test firstly determined if there was a significant downward trend in response for the descending doses, and then subsequently determined the highest dose that was statistically inferior to 20 mg (known to be an effective dose of sildenafil). A corresponding 97.5% lower confidence limit for the difference was presented.|||-21.48|0.545
70948045|NCT00267098|141396960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.8416|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Probability of Mean QOL Change|The parameter of interest was the BiV - RV difference in mean QOL change from randomization to 18 months.||"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in QOL score from randomization to 18 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a greater reduction (and thus improvement) in QOL score at 18 months than patients with right ventricular pacing."||||0.8416
70954406|NCT03568318|141411416|SUPERIORITY||LS Mean Difference|-35.69|STANDARD_ERROR_OF_MEAN|5.354|<|0.001|TWO_SIDED|95.0|-46.28|-25.11|||Mixed Effect Model Repeated Measurement|Mixed-Effect Model Repeat Measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-25.11|-46.28|<0.001
71136306|NCT00430716|141774322|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.51||||0.278|TWO_SIDED|95.0|-7.07|2.05|||ANCOVA|||The analysis of change from baseline in week 12 mean PAP used Analysis of Covariance (ANCOVA), with etiology and baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (1 mg) was presented along with the p-value for the test.||2.05|-7.07|0.278
71136307|NCT00430716|141774322|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.44||||0.846|TWO_SIDED|95.0|-4.98|4.09|||ANCOVA|||The analysis of change from baseline in week 12 mean PAP used ANCOVA, with etiology and baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (5 mg) was presented along with the p-value for the test.||4.09|-4.98|0.846
71136308|NCT00430716|141774324|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.448|TWO_SIDED|95.0|0.5|4.78|||Regression, Logistic|||The analysis of the week 12 PAH functional class was done with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates.The odds ratio and corresponding two-sided 95% CI for the odds ratio for the treatment comparisons was presented along with the p-value for the tests.||4.78|0.50|0.448
71136309|NCT00430716|141774324|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.08||||0.897|TWO_SIDED|95.0|0.35|3.32|||Regression, Logistic|||The analysis of the week 12 PAH functional class was done with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates.The odds ratio and corresponding two-sided 95% CI for the odds ratio for the treatment comparisons was presented along with the p-value for the tests.||3.32|0.35|0.897
71136310|NCT00430716|141774325|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-104.8||||0.005|TWO_SIDED|95.0|-177.44|-32.16|||ANCOVA|||ANCOVA method was used with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (1 mg) was presented along with the p-value for the test.||-32.16|-177.44|0.005
71136311|NCT00430716|141774325|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-25.0||||0.496|TWO_SIDED|95.0|-97.5|47.5|||ANCOVA|||ANCOVA method was used with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (5 mg) was presented along with the p-value for the test.||47.50|-97.50|0.496
71136312|NCT00430716|141774326|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-462.12||||0.009|TWO_SIDED|95.0|-807.53|-116.71|||ANCOVA|||ANCOVA method was used with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (1 mg) was presented along with the p-value for the test.||-116.71|-807.53|0.009
71136313|NCT00430716|141774326|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|-141.45||||0.414|TWO_SIDED|95.0|-483.48|200.58|||ANCOVA|||ANCOVA method was used with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (5 mg) was presented along with the p-value for the test.||200.58|-483.48|0.414
71136314|NCT00430716|141774327|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.01||||0.89|TWO_SIDED|95.0|-0.17|0.15|||ANCOVA|||ANCOVA method was used with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (1 mg) was presented along with the p-value for the test.||0.15|-0.17|0.890
71136315|NCT00430716|141774327|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.13||||0.124|TWO_SIDED|95.0|-0.29|0.04|||ANCOVA|||ANCOVA method was used with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (5 mg) was presented along with the p-value for the test.||0.04|-0.29|0.124
71136316|NCT00430716|141774328|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|0.0||||0.382|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Van-Elteren)|||A stratified Wilcoxon test (Van-Elteren) was used. The stratified median difference and corresponding two-sided 95% CI (calculated using the Hodges-Lehmann estimator) was presented along with the p-value for the test.||0.00|-1.00|0.382
71136317|NCT00430716|141774328|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.141|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Van-Elteren)|||A stratified Wilcoxon test (Van-Elteren) was used. The stratified median difference and corresponding two-sided 95% CI (calculated using the Hodges-Lehmann estimator) was presented along with the p-value for the test.||1.00|0.00|0.141
71136318|NCT00773513|141774332|NON_INFERIORITY|The critical alpha level for the non-inferiority test was 0.025.|Hazard Ratio (HR)|1.03||||0.0039|TWO_SIDED|95.0|0.93|1.15|||Regression, Cox||The pre-specified upper non-inferiority limit was 95% CI \<1.20.|||1.15|0.93|0.0039
71136319|NCT00773513|141774333|NON_INFERIORITY|The critical alpha level for the non-inferiority test was 0.025|Hazard Ratio (HR)|1.06||||0.0166|TWO_SIDED|95.0|0.94|1.19|||Regression, Cox|||||1.19|0.94|0.0166
71136320|NCT00773513|141774334|NON_INFERIORITY|The critical alpha level for the non-inferiority test was 0.025|Hazard Ratio (HR)|0.95||||0.0219|TWO_SIDED|95.0|0.76|1.19|||Regression, Cox|||||1.19|0.76|0.0219
71136321|NCT00773513|141774335|NON_INFERIORITY|The critical alpha level for the non-inferiority test was 0.025|Hazard Ratio (HR)|0.94||||0.0459|TWO_SIDED|95.0|0.7|1.25|||Regression, Cox|||||1.25|0.70|0.0459
71136322|NCT00773513|141774336|NON_INFERIORITY|The critical alpha level for the non-inferiority test was 0.025|Hazard Ratio (HR)|0.91||||0.0048|TWO_SIDED|95.0|0.74|1.12|||Regression, Cox|||||1.12|0.74|0.0048
71136323|NCT03890588|141774340|SUPERIORITY||Risk Ratio (RR)|1.17|STANDARD_ERROR_OF_MEAN|0.12||0.21|TWO_SIDED|95.0|0.91|1.51|||Mixed Models Analysis|||||1.51|.91|.21
71136324|NCT03890588|141774341|SUPERIORITY||Risk Ratio (RR)|0.95|STANDARD_ERROR_OF_MEAN|0.11||0.61|TWO_SIDED|95.0|0.76|1.18|||Mixed Models Analysis|||||1.18|.76|.61
71136325|NCT03890588|141774342|SUPERIORITY||Risk Ratio (RR)|0.98|STANDARD_ERROR_OF_MEAN|0.08||0.84|TWO_SIDED|95.0|0.84|1.15|||Mixed Models Analysis|||||1.15|0.84|.84
71136326|NCT03890588|141774343|SUPERIORITY||Risk Ratio (RR)|1.0|STANDARD_ERROR_OF_MEAN|0.11||0.99|TWO_SIDED|95.0|0.8|1.24|||Mixed Models Analysis|||||1.24|.8|.99
71136327|NCT03890588|141774344|SUPERIORITY||Risk Ratio (RR)|1.02|STANDARD_ERROR_OF_MEAN|0.12||0.86|TWO_SIDED|95.0|0.79|1.32|||Mixed Models Analysis|||||1.32|.79|.86
71136328|NCT02719171|141774359|OTHER||Mean Difference (Final Values)|24.0||||0.007|TWO_SIDED|90.0|9.3|38.7|||Cochran-Mantel-Haenszel|||The 90% confidence interval (CI) for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior tumor necrosis factor inhibitor (TNFi) use and concurrent methotrexate use.||38.7|9.3|0.007
71136329|NCT02719171|141774360|OTHER||Mean Difference (Final Values)|12.0||||0.074|TWO_SIDED|90.0|1.0|23.0|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.||23.0|1.0|0.074
71136330|NCT02719171|141774360|OTHER||Mean Difference (Final Values)|19.0||||0.007|TWO_SIDED|90.0|7.4|30.6|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.||30.6|7.4|0.007
71136331|NCT02719171|141774361|OTHER||Mean Difference (Final Values)|10.3||||0.006|TWO_SIDED|90.0|4.1|16.4|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.||16.4|4.1|0.006
71136332|NCT02719171|141774361|OTHER||Mean Difference (Final Values)|15.7|||<|0.001|TWO_SIDED|90.0|8.5|22.9|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.||22.9|8.5|<0.001
71136333|NCT02719171|141774362|OTHER||Mean Difference (Final Values)|-0.8||||0.69|TWO_SIDED|90.0|-4.0|2.5|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||2.5|-4.0|0.690
71136334|NCT02719171|141774362|OTHER||Mean Difference (Final Values)|-2.1||||0.26|TWO_SIDED|90.0|-5.3|1.0|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||1.0|-5.3|0.260
71136335|NCT02719171|141774363|OTHER||Mean Difference (Final Values)|-0.3||||0.791|TWO_SIDED|90.0|-2.1|1.5|||Cochran-Mantel-Haenszel|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||1.5|-2.1|0.791
71136336|NCT02719171|141774363|OTHER||Mean Difference (Final Values)|-1.1||||0.32|TWO_SIDED|90.0|-2.8|0.7|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||0.7|-2.8|0.320
71136337|NCT02719171|141774364|OTHER||mixed model repeated measures model|-0.082||||0.341|TWO_SIDED|90.0|-0.225|0.06|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||0.060|-0.225|0.341
70954407|NCT03568318|141411416|SUPERIORITY||LS Mean Difference|-24.37|STANDARD_ERROR_OF_MEAN|5.423|<|0.001|TWO_SIDED|95.0|-35.1|-13.65|||Mixed Effect Model Repeated Measurement|Mixed-Effect Model Repeat Measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-13.65|-35.10|<0.001
71136338|NCT02719171|141774364|OTHER||Mean Difference (Final Values)|-0.114||||0.181|TWO_SIDED|90.0|-0.254|0.027|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||0.027|-0.254|0.181
71136339|NCT02719171|141774365|OTHER||Mean Difference (Final Values)|1.7||||0.174|TWO_SIDED|90.0|-0.36|3.77|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||3.77|-0.36|0.174
71136340|NCT02719171|141774365|OTHER||Mean Difference (Final Values)|1.35||||0.284|TWO_SIDED|90.0|-0.73|3.44|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||3.44|-0.73|0.284
71136341|NCT02719171|141774366|OTHER||Mean Difference (Final Values)|0.59||||0.718|TWO_SIDED|90.0|-2.12|3.3|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||3.30|-2.12|0.718
71136342|NCT02719171|141774366|OTHER||Mean Difference (Final Values)|2.06||||0.204|TWO_SIDED|90.0|-0.61|4.74|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||4.74|-0.61|0.204
71136343|NCT02719171|141774367|OTHER||Mean Difference (Final Values)|1.2||||0.243|TWO_SIDED|90.0|-0.5|2.8|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||2.8|-0.5|0.243
71136344|NCT02719171|141774367|OTHER||Mean Difference (Final Values)|0.1||||0.906|TWO_SIDED|90.0|-1.0|1.1|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||1.1|-1.0|0.906
71136345|NCT02719171|141774368|OTHER||Mean Difference (Final Values)|-0.7||||0.325|TWO_SIDED|90.0|-1.8|0.5|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||0.5|-1.8|0.325
71136346|NCT02719171|141774368|OTHER||Mean Difference (Final Values)|-0.9||||0.16|TWO_SIDED|90.0|-2.1|0.2|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||0.2|-2.1|0.160
71136347|NCT02719171|141774369|OTHER||Mean Difference (Final Values)|-1.2||||0.453|TWO_SIDED|90.0|-4.0|1.5|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||1.5|-4.0|0.453
71136348|NCT02719171|141774369|OTHER||Mean Difference (Final Values)|-2.8||||0.111|TWO_SIDED|90.0|-5.7|0.1|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||0.1|-5.7|0.111
71136349|NCT02719171|141774370|OTHER||Mean Difference (Final Values)|53.5|||<|0.001|TWO_SIDED|90.0|35.9|71.1|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.||71.1|35.9|<0.001
71136350|NCT02719171|141774370|OTHER||Mean Difference (Final Values)|48.8|||<|0.001|TWO_SIDED|90.0|33.1|64.5|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.||64.5|33.1|<0.001
71136351|NCT02796677|141774371|SUPERIORITY||LS mean difference|0.084|||<|0.0001|TWO_SIDED|95.0|0.051|0.117|||Mixed model for repeated measures|||||0.117|0.051|<0.0001
71136352|NCT02796677|141774372|SUPERIORITY||LS mean difference|0.055||||0.0009|TWO_SIDED|95.0|0.023|0.088|||Mixed model for repeated measures|||||0.088|0.023|0.0009
71136353|NCT02796677|141774373|NON_INFERIORITY|Non-inferiority was established by showing that the lower bound of the two-sided 95% confidence interval for change from baseline in morning pre-dose (trough) FEV1 at week 24 when compared AB 400 μg versus TIO 18 μg was higher than -50 mL (non-inferiority limit).|LS mean difference|0.007||||0.6377|TWO_SIDED|95.0|-0.021|0.035|||Mixed model for repeated measures|||||0.035|-0.021|0.6377
71136354|NCT02796677|141774374|SUPERIORITY||LS mean difference|0.075|||<|0.0001|TWO_SIDED|95.0|0.043|0.107|||Mixed model for repeated measures|||||0.107|0.043|<0.0001
71136355|NCT02796677|141774374|SUPERIORITY||LS mean difference|0.087|||<|0.0001|TWO_SIDED|95.0|0.052|0.122|||Mixed model for repeated measures|||||0.122|0.052|<0.0001
71136356|NCT02796677|141774375|SUPERIORITY||Odds ratio|0.96||||0.8714|TWO_SIDED|95.0|0.61|1.51|||Logistic random-effect model|||||1.51|0.61|0.8714
71136357|NCT02796677|141774375|SUPERIORITY||Odds ratio|0.97||||0.8873|TWO_SIDED|95.0|0.59|1.58|||Logistic random-effect model|||||1.58|0.59|0.8873
70862881|NCT01886716|141212676|SUPERIORITY_OR_OTHER||Slope|0.27|STANDARD_ERROR_OF_MEAN|0.95|=|0.78|TWO_SIDED||||||Mixed Models Analysis||F(1,517) = .08|"The analyses used multilevel modeling to capture both the trajectories of symptoms within individuals (i.e., level 1) and the hypothesized between-subject moderators of these trajectories, alcohol and anxiety attention training (i.e., level 2) across all 7 time points.~Note, although all 4 groups are included in this analysis, this analysis specifically compares alcohol vs. control training."||||=.78
70862882|NCT01886716|141212677|SUPERIORITY_OR_OTHER||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.07|=|0.67|TWO_SIDED||||||Mixed Models Analysis||F(1,517) = .18|"The analyses used multilevel modeling to capture both the trajectories of symptoms within individuals (i.e., level 1) and the hypothesized between-subject moderators of these trajectories, alcohol and anxiety attention training (i.e., level 2) across all 7 time points.~Note, although all 4 groups are included in this analysis, this analysis specifically compares alcohol vs. control training"||||=.67
70862883|NCT01886716|141212677|SUPERIORITY_OR_OTHER||Slope|0.07|STANDARD_ERROR_OF_MEAN|0.07|=|0.32|TWO_SIDED||||||Mixed Models Analysis||F(1,517) = 1.01|"The analyses used multilevel modeling to capture both the trajectories of symptoms within individuals (i.e., level 1) and the hypothesized between-subject moderators of these trajectories, alcohol and anxiety attention training (i.e., level 2) across all 7 time points.~Note, although all 4 groups are included in this analysis, this analysis specifically compares anxiety vs. control training"||||=.32
70862884|NCT03894046|141212697|NON_INFERIORITY|"Non-inferiority was concluded if the upper limit of the 2-sided 95% CI was less than +20%.~Superiority was concluded if the upper limit of the 2-sided 95% CI was less than 0."|Mean Difference (Final Values)|-13.2|||||TWO_SIDED|95.0|-30.0|3.5||||||The non-inferiority assessment was based on the 2-sided 95% CIs computed using a continuity-corrected Z-statistic for the difference (\[sulbactam-durlobactam + imipenem/cilastatin\] - \[colistin + imipenem/cilastatin\]) in 28-day all-cause mortality rates between the treatment groups.||3.5|-30|
70862885|NCT03894046|141212698|OTHER|||||||0.0002||||||p-value was obtained based on a Chi-Square test for treatment group differences.|Chi-squared|||Analysis of patients with nephrotoxicity as measured by RIFLE criteria at any post-baseline visit based on the Investigator's opinion for the Safety Population for Part A, excluding patients with chronic hemodialysis at baseline baseline.||||0.0002
70862886|NCT01973569|141212702|SUPERIORITY|||||||0.0235||||||The hierarchical testing procedure was applied for multiple comparisons of the primary endpoint. First, comparison between AMG 162 60mg Q3M vs placebo is tested. Only if it is rejected, comparison of AMG 162 60mg Q6M vs placebo is formally tested.|van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.||||||0.0235
70862887|NCT01973569|141212703|SUPERIORITY|||||||0.036|||||||van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.||||||0.0360
70862888|NCT01973569|141212704|SUPERIORITY|||||||0.1323|||||||van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.||||||0.1323
70862889|NCT01973569|141212705|SUPERIORITY|||||||0.0448|||||||van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.||||||0.0448
70862890|NCT01973569|141212706|SUPERIORITY|||||||0.0104|||||||van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.||||||0.0104
70862891|NCT01973569|141212707|SUPERIORITY|||||||0.257|||||||van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.||||||0.2570
70862892|NCT01973569|141212708|SUPERIORITY||Mean Difference (Net)|5.02|||<|0.0001|TWO_SIDED|95.0|4.41|5.63|||Regression, Cox|ANCOVA model adjusting for treatment, baseline (BL) value, machine type, BL value-by-machine type interaction, and BL use of glucocorticoid was used.||||5.63|4.41|<0.0001
70862893|NCT00137631|141212715|SUPERIORITY_OR_OTHER||Rate Ratio|0.58|||<|0.05||95.0|0.33|1.01|||negative binomial regression|||||1.01|0.33|< 0.05
70862894|NCT00137631|141212716|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33|||<|0.05||95.0|1.05|1.68|||generalized estimating equations|Tests intervention efficacy over all study periods (baseline, 3-months, and 6-months)||||1.68|1.05|< 0.05
70862895|NCT00137631|141212717|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17|||<|0.05||95.0|0.69|1.98|||Mixed Models Analysis|||||1.98|0.69|< 0.05
70862896|NCT00137631|141212718|SUPERIORITY_OR_OTHER||Rate Ratio|0.49|||<|0.05||95.0|0.28|0.87|||generalized estimating equations|Tests intervention efficacy over all study periods (baseline, 3-months, and 6-months)||||0.87|0.28|< 0.05
70862897|NCT00137631|141212719|SUPERIORITY_OR_OTHER||Rate Ratio|0.8|||<|0.05||95.0|0.42|1.53|||generalized estimating equations|Tests intervention efficacy over all study periods (baseline, 3-months, and 6-months)||||1.53|0.42|< 0.05
70862898|NCT00351000|141212720|SUPERIORITY_OR_OTHER|||||||0.956||95.0|||||t-test, 2 sided|||||||0.956
70862899|NCT00351000|141212721|SUPERIORITY_OR_OTHER|||||||0.988||95.0|||||t-test, 2 sided|||||||0.988
70862900|NCT05015530|141212817|SUPERIORITY|||||||0.908|||||||Kruskal-Wallis|||α-diversity assessed using the Kruskal-Wallis test||||0.908
70862901|NCT00567593|141212826|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum test||||||.01
70862902|NCT01675427|141212850|SUPERIORITY_OR_OTHER|||||||0.0018|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1||||0.0018
70862903|NCT01675427|141212850|SUPERIORITY_OR_OTHER|||||||0.2289|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2||||0.2289
70862904|NCT01675427|141212850|SUPERIORITY_OR_OTHER|||||||0.1112|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3||||0.1112
70862905|NCT01675427|141212850|SUPERIORITY_OR_OTHER|||||||0.4681|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4||||0.4681
70862906|NCT01675427|141212850|SUPERIORITY_OR_OTHER|||||||0.4828|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.4828
70862907|NCT01675427|141212850|SUPERIORITY_OR_OTHER|||||||0.2702|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.2702
70862908|NCT01675427|141212851|SUPERIORITY_OR_OTHER|||||||0.4133|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1||||0.4133
70862909|NCT01675427|141212851|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2||||0.4400
70862910|NCT01675427|141212851|SUPERIORITY_OR_OTHER|||||||0.8597|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3||||0.8597
70862911|NCT01675427|141212851|SUPERIORITY_OR_OTHER|||||||0.3975|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4||||0.3975
70862912|NCT01675427|141212851|SUPERIORITY_OR_OTHER|||||||0.1781|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.1781
70862913|NCT01675427|141212851|SUPERIORITY_OR_OTHER|||||||0.3159|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.3159
70862914|NCT01675427|141212852|SUPERIORITY_OR_OTHER|||||||0.0126|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1||||0.0126
70862915|NCT01675427|141212852|SUPERIORITY_OR_OTHER|||||||0.7174|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2||||0.7174
70862916|NCT01675427|141212852|SUPERIORITY_OR_OTHER|||||||0.138|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3||||0.1380
70862917|NCT01675427|141212852|SUPERIORITY_OR_OTHER|||||||0.6258|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4||||0.6258
70862918|NCT01675427|141212852|SUPERIORITY_OR_OTHER|||||||0.5751|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.5751
70862919|NCT01675427|141212852|SUPERIORITY_OR_OTHER|||||||0.1681|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.1681
70862920|NCT01675427|141212853|SUPERIORITY_OR_OTHER|||||||0.2693|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1||||0.2693
70862921|NCT01675427|141212853|SUPERIORITY_OR_OTHER|||||||0.324|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2||||0.3240
70862922|NCT01675427|141212853|SUPERIORITY_OR_OTHER|||||||0.7006|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3||||0.7006
70862923|NCT01675427|141212853|SUPERIORITY_OR_OTHER|||||||0.0403|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4||||0.0403
70862924|NCT01675427|141212853|SUPERIORITY_OR_OTHER|||||||0.1075|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.1075
70862925|NCT01675427|141212853|SUPERIORITY_OR_OTHER|||||||0.3295|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.3295
70862926|NCT01675427|141212854|SUPERIORITY_OR_OTHER|||||||0.9859|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.9859
70862927|NCT01675427|141212854|SUPERIORITY_OR_OTHER|||||||0.7055|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.7055
70862928|NCT01675427|141212854|SUPERIORITY_OR_OTHER|||||||0.092|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0920
70862929|NCT01675427|141212854|SUPERIORITY_OR_OTHER|||||||0.0781|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.0781
70862930|NCT01675427|141212854|SUPERIORITY_OR_OTHER|||||||0.4795|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.4795
70862931|NCT01675427|141212854|SUPERIORITY_OR_OTHER|||||||0.3069|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.3069
70862932|NCT01675427|141212855|SUPERIORITY_OR_OTHER|||||||0.5216|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.5216
70862933|NCT01675427|141212855|SUPERIORITY_OR_OTHER|||||||0.3419|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.3419
70862934|NCT01675427|141212855|SUPERIORITY_OR_OTHER|||||||0.7586|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.7586
70862935|NCT01675427|141212855|SUPERIORITY_OR_OTHER|||||||0.1351|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.1351
70862936|NCT01675427|141212855|SUPERIORITY_OR_OTHER|||||||0.2386|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2386
70862937|NCT01675427|141212855|SUPERIORITY_OR_OTHER|||||||0.3921|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.3921
70862938|NCT01675427|141212856|SUPERIORITY_OR_OTHER|||||||0.8537|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.8537
70862939|NCT01675427|141212856|SUPERIORITY_OR_OTHER|||||||0.0763|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0763
70862940|NCT01675427|141212856|SUPERIORITY_OR_OTHER|||||||0.2432|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.2432
70862941|NCT01675427|141212856|SUPERIORITY_OR_OTHER|||||||0.4247|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.4247
70862942|NCT01675427|141212856|SUPERIORITY_OR_OTHER|||||||0.4884|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.4884
70948046|NCT00267098|141396961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.727|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Probability of Mean QOL Change|The posterior distribution for the BiV - RV difference in mean QOL score improvement from randomization to 24 months was determined.||"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in QOL score from randomization to 24 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a greater reduction (and thus improvement) in QOL score at 24 months than patients with right ventricular pacing."||||0.7270
71136358|NCT01045967|141774388|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.0|||||TWO_SIDED|90.0|90.7|122.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||122|90.7|
71136359|NCT01045967|141774389|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.2|||||TWO_SIDED|90.0|86.1|110.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||110|86.1|
71136360|NCT01045967|141774390|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.4|||||TWO_SIDED|90.0|86.3|110.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||110|86.3|
71136361|NCT01290614|141774548|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||t-test, 2 sided|||||||0.57
71136362|NCT01290614|141774549|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71136363|NCT01825187|141774560|SUPERIORITY|||||||0.523|||||||t-test, 1 sided|||||||0.523
71136364|NCT01825187|141774561|SUPERIORITY|||||||0.371|||||||t-test, 1 sided|||Nasa Mental Demand||||0.371
71136365|NCT01825187|141774561|SUPERIORITY|||||||0.122|||||||t-test, 1 sided|||NASA Physical Demand||||0.122
71136366|NCT01825187|141774561|SUPERIORITY|||||||0.325|||||||t-test, 1 sided|||NASA Temporal Demand||||0.325
71136367|NCT01825187|141774561|SUPERIORITY|||||||0.0451|||||||t-test, 1 sided|||NASA Peformance||||0.0451
71136368|NCT01363700|141774588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||<|0.001|TWO_SIDED|95.0|-1.52|-1.11|||t-test, 2 sided|||||-1.11|-1.52|<0.001
71136369|NCT01363700|141774589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||<|0.001|TWO_SIDED|95.0|-1.71|-0.92|||t-test, 2 sided|||||-0.92|-1.71|<0.001
71136370|NCT01363700|141774590|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority in Mean Ocular itching score compared to Olopatadine was assessed on the non-inferiority margin (0.5) with the upper limit of the confidence interval of the difference between the Epinastine (DE-114) and Olopatadine treatment groups.|Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.21|0.08||||||||0.08|-0.21|
71136371|NCT01363700|141774591|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority in Mean Ocular hyperemia score compared to Olopatadine was assessed on the non-inferiority margin (0.5) with the upper limit of the confidence interval of the difference between the Epinastine (DE-114) and Olopatadine treatment groups.|Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-0.81|0.22||||||||0.22|-0.81|
71136372|NCT02119871|141774594|SUPERIORITY||Median Difference (Final Values)|14.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.00
71136373|NCT02119871|141774595|SUPERIORITY||Median Difference (Final Values)|10.0||||0.656|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.656
71136374|NCT02119871|141774596|SUPERIORITY||Median Difference (Final Values)|4.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1
71136375|NCT01329978|141774624|SUPERIORITY_OR_OTHER||Difference in proportions|-1.4||||0.77|TWO_SIDED|95.0|-12.2|9.4||The p-value is based on the Cochran-Mantel-Haenszel (CMH) test stratified by randomization stratification factors.|Cochran-Mantel-Haenszel||The difference in proportions and its 95% confidence interval (CI) were calculated based on stratum-adjusted Mantel-Haenszel (MH) proportions.|The analyses was stratified by IL28B (CC versus any T allele) and plasma HCV RNA (\< 800,000 IU/mL versus ≥ 800,000 IU/mL). Only participants with genotype 1 were included in the comparison due to the fact that participants with genotype 4 and 6 were only enrolled in the SOF+PEG+RBV 24 weeks group.||9.4|-12.2|0.77
71136376|NCT01329978|141774624|SUPERIORITY_OR_OTHER||Difference in proportions|-0.4||||0.93|TWO_SIDED|95.0|-10.8|9.9||The p-value is based on the CMH test stratified by randomization stratification factors.|Cochran-Mantel-Haenszel|The difference in proportions and its 95% CI were calculated based on stratum-adjusted MH proportions.||The analyses was stratified by IL28B (CC versus any T allele) and plasma HCV RNA (\< 800,000 IU/mL versus ≥ 800,000 IU/mL).||9.9|-10.8|0.93
71136377|NCT03324802|141774646|SUPERIORITY|||||||1|||||||Log Rank|||||||1.0
71136378|NCT03324802|141774647|SUPERIORITY|||||||1|||||||Log Rank|||||||1.0
71136379|NCT03324802|141774649|SUPERIORITY|||||||0.32|||||||Chi-squared|||||||0.320
71136380|NCT03324802|141774650|SUPERIORITY|||||||0.163|||||||Chi-squared|||||||0.163
71136381|NCT03324802|141774651|SUPERIORITY|||||||0.97|||||||Log Rank|||||||0.97
71136382|NCT03324802|141774652|SUPERIORITY|||||||0.5|||||||Gray Test P-value|||||||0.5
71136383|NCT03324802|141774653|SUPERIORITY|||||||0.54|||||||Log Rank|||||||0.54
70954408|NCT05126563|141411469|SUPERIORITY||LS Means|0.054|STANDARD_ERROR_OF_MEAN|0.738||0.9416|TWO_SIDED|95.0|-1.42|1.53|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Extreme fatigue scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.53|-1.42|0.9416
70862943|NCT01675427|141212856|SUPERIORITY_OR_OTHER|||||||0.6119|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.6119
70862944|NCT01675427|141212857|SUPERIORITY_OR_OTHER|||||||0.2416|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.2416
70862945|NCT01675427|141212857|SUPERIORITY_OR_OTHER|||||||0.2671|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2671
70862946|NCT01675427|141212857|SUPERIORITY_OR_OTHER|||||||0.4619|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.4619
70862947|NCT01675427|141212857|SUPERIORITY_OR_OTHER|||||||0.8364|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.8364
70862948|NCT01675427|141212857|SUPERIORITY_OR_OTHER|||||||0.2386|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2386
70862949|NCT01675427|141212857|SUPERIORITY_OR_OTHER|||||||0.2887|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.2887
70862950|NCT01675427|141212858|SUPERIORITY_OR_OTHER|||||||0.0049|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||||||0.0049
70862951|NCT01675427|141212859|SUPERIORITY_OR_OTHER|||||||0.5651|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||||||0.5651
70862952|NCT01675427|141212860|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||||||0.0420
70862953|NCT01675427|141212861|SUPERIORITY_OR_OTHER|||||||0.4545|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||||||0.4545
70862954|NCT01675427|141212862|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
70862955|NCT01675427|141212863|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
70862956|NCT01675427|141212864|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
70862957|NCT01675427|141212865|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
70862958|NCT01675427|141212866|SUPERIORITY_OR_OTHER|||||||0.5468|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.5468
70862959|NCT01675427|141212867|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.0020
70862960|NCT01675427|141212868|SUPERIORITY_OR_OTHER|||||||0.1623|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.1623
70862961|NCT01675427|141212869|SUPERIORITY_OR_OTHER|||||||0.0663|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.0663
70862962|NCT01675427|141212870|SUPERIORITY_OR_OTHER|||||||0.2617|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.2617
70862963|NCT01675427|141212871|SUPERIORITY_OR_OTHER|||||||0.0526|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.0526
70862964|NCT01675427|141212872|SUPERIORITY_OR_OTHER|||||||0.7918|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.7918
70862965|NCT01675427|141212873|SUPERIORITY_OR_OTHER|||||||0.0842|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.0842
70862966|NCT01675427|141212874|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
70862967|NCT01675427|141212875|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
70862968|NCT01675427|141212876|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
70862969|NCT01675427|141212877|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
70862970|NCT01675427|141212878|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
70862971|NCT01675427|141212878|SUPERIORITY_OR_OTHER|||||||0.2887|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2887
70862972|NCT01675427|141212878|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||< 0.0001
70862973|NCT01675427|141212878|SUPERIORITY_OR_OTHER|||||||0.1634|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.1634
70862974|NCT01675427|141212878|SUPERIORITY_OR_OTHER|||||||0.8956|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.8956
70862975|NCT01675427|141212878|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
70862976|NCT01675427|141212879|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
71136384|NCT00287716|141774664|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.023|TWO_SIDED|95.0|0.44|0.95|||Log Rank|||The null hypothesis is that there is no treatment difference between the pirfenidone 2403 mg/day treatment group and the placebo treatment group.||0.95|0.44|0.023
71136385|NCT00287716|141774670|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.515|TWO_SIDED|95.0|0.5|1.42|||Log Rank|||The null hypothesis is that there is no treatment difference between the pirfenidone 2403-mg/d treatment group and the placebo treatment group.||1.42|0.50|0.515
71136386|NCT04170543|141774673|OTHER||LS Mean Difference in Percent Change|-2.85||||0.8338|TWO_SIDED|90.0|-22.61|21.94||Unadjusted two-sided p-value|MMRM||MEDI3506 30 mg - Placebo|||21.94|-22.61|0.8338
71136387|NCT04170543|141774673|OTHER||LS Mean Difference in Percent Change|-19.52||||0.1169|TWO_SIDED|90.0|-35.92|1.07||Unadjusted two-sided p-value|MMRM||MEDI3506 60 mg - Placebo|||1.07|-35.92|0.1169
71136388|NCT04170543|141774673|OTHER||LS Mean Difference in Percent Change|-17.47||||0.1774|TWO_SIDED|90.0|-34.71|4.32||Unadjusted two-sided p-value|MMRM||MEDI3506 120 mg - Placebo|||4.32|-34.71|0.1774
71136389|NCT04170543|141774673|OTHER||LS Mean Difference in Percent Change|-7.22||||0.5379|TWO_SIDED|90.0|-24.05|13.35||Unadjusted two-sided p-value|MMRM|||||13.35|-24.05|0.5379
71136390|NCT04170543|141774674|OTHER||LS Mean Difference in Percent Change|-13.02||||0.1929|TWO_SIDED|90.0|-27.08|3.75||Unadjusted two-sided p-value|MMRM||MEDI3506 30 mg - Placebo|||3.75|-27.08|0.1929
71136391|NCT04170543|141774674|OTHER||LS Mean Difference in Percent Change|-25.71||||0.0062|TWO_SIDED|90.0|-37.83|-11.22||Unadjusted two-sided p-value|MMRM||MEDI3506 60 mg - Placebo|||-11.22|-37.83|0.0062
71136392|NCT04170543|141774674|OTHER||LS Mean Difference in Percent Change|-18.2||||0.0705|TWO_SIDED|90.0|-31.86|-1.81||Unadjusted two-sided p-value|MMRM||MEDI3506 120 mg - Placebo|||-1.81|-31.86|0.0705
71136393|NCT04170543|141774674|OTHER||LS Mean Difference in Percent Change|-15.56||||0.0764|TWO_SIDED|90.0|-27.82|-1.21||Unadjusted two-sided p-value|MMRM|||||-1.21|-27.82|0.0764
71136394|NCT04170543|141774675|OTHER||LS Mean Difference in Percent Change|7.25||||0.5474|TWO_SIDED|90.0|-11.45|29.88||Unadjusted two-sided p-value|MMRM||MEDI3506 30 mg - Placebo|||29.88|-11.45|0.5474
71136395|NCT04170543|141774675|OTHER||LS Mean Difference in Percent Change|3.11||||0.792|TWO_SIDED|90.0|-14.83|24.82||Unadjusted two-sided p-value|MMRM||MEDI3506 60 mg - Placebo|||24.82|-14.83|0.7920
71136396|NCT04170543|141774675|OTHER||LS Mean Difference in Percent Change|-3.4||||0.7711|TWO_SIDED|90.0|-20.59|17.51||Unadjusted two-sided p-value|MMRM||MEDI3506 120 mg - Placebo|||17.51|-20.59|0.7711
71136397|NCT04170543|141774675|OTHER||LS Mean Difference in Percent Change|5.27||||0.6163|TWO_SIDED|90.0|-11.08|24.62||Unadjusted two-sided p-value|MMRM|||||24.62|-11.08|0.6163
71136398|NCT04170543|141774677|OTHER||LS Mean Difference in Percent Change|2.43||||0.8537|TWO_SIDED|90.0|-17.35|26.95||Unadjusted two-sided p-value|MMRM||MEDI3506 30 mg - Placebo|||26.95|-17.35|0.8537
71136399|NCT04170543|141774677|OTHER||LS Mean Difference in Percent Change|-15.63||||0.1989|TWO_SIDED|90.0|-32.14|4.89||Unadjusted two-sided p-value|MMRM||MEDI3506 60 mg - Placebo|||4.89|-32.14|0.1989
71136400|NCT04170543|141774677|OTHER||LS Mean Difference in Percent Change|-17.96||||0.1346|TWO_SIDED|90.0|-34.01|1.99||Unadjusted two-sided p-value|MMRM||MEDI3506 120 mg - Placebo|||1.99|-34.01|0.1346
71136401|NCT04170543|141774677|OTHER||LS Mean Difference in Percent Change|-6.38||||0.5683|TWO_SIDED|90.0|-22.59|13.23||Unadjusted two-sided p-value|MMRM|||||13.23|-22.59|0.5683
71136402|NCT04170543|141774678|OTHER||LS Mean Difference in Percent Change|-7.93||||0.4226|TWO_SIDED|90.0|-22.3|9.1||Unadjusted two-sided p-value|MMRM||MEDI3506 30 mg - Placebo|||9.10|-22.30|0.4226
71136403|NCT04170543|141774678|OTHER||LS Mean Difference in Percent Change|-20.61||||0.0287|TWO_SIDED|90.0|-33.25|-5.58||Unadjusted two-sided p-value|MMRM||MEDI3506 60 mg - Placebo|||-5.58|-33.25|0.0287
71136404|NCT04170543|141774678|OTHER||LS Mean Difference in Percent Change|-18.73||||0.0498|TWO_SIDED|90.0|-31.7|-3.3||Unadjusted two-sided p-value|MMRM||MEDI3506 120 mg - Placebo|||-3.30|-31.70|0.0498
71136405|NCT04170543|141774678|OTHER||LS Mean Difference in Percent Change|-13.27||||0.1236|TWO_SIDED|90.0|-25.51|0.98||Unadjusted two-sided p-value|MMRM|||||0.98|-25.51|0.1236
71136406|NCT04037891|141774693|SUPERIORITY||Difference of percentage of participants|16.7|||||TWO_SIDED|95.0|-53.57|72.99||||||||72.99|-53.57|
71136407|NCT04037891|141774693|SUPERIORITY||Difference of percentage of participants|33.3|||||TWO_SIDED|95.0|-25.45|78.39||||||Comparison of incidence of ocular TEAE in all patients receiving rVA576 (part 1 and 2) vs placebo||78.39|-25.45|
71136408|NCT05274958|141774704|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||Patient measures for both groups were first summarized descriptively with means and standard deviations. To compare the two groups, a t-test was used.||||<0.05
71136409|NCT04491136|141774715|OTHER||||||>|0.9999|||||||McNemar|||At least one SVT occurred||||>0.9999
71136410|NCT04491136|141774715|OTHER|||||||0.7905|||||||McNemar|||At least one NSVT occurred||||0.7905
71136411|NCT04491136|141774715|OTHER|||||||0.625|||||||McNemar|||At least one PVC occurred||||0.6250
71136412|NCT04491136|141774717|OTHER||Mean Difference (Final Values)|2.41|STANDARD_ERROR_OF_MEAN|0.653||0.0008|TWO_SIDED|95.0|1.11|3.7|||Wilcoxon signed-rank|||||3.70|1.11|0.0008
71136413|NCT04491136|141774718|OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.028||0.5733|TWO_SIDED|95.0|-0.07|0.04|||Ridit analysis|||||0.04|-0.07|0.5733
71136414|NCT04491136|141774719|OTHER||Mean Difference (Final Values)|-231.46|STANDARD_ERROR_OF_MEAN|93.03||0.0006|TWO_SIDED|95.0|-415.9|-47.02|||Wilcoxon signed rank test|||||-47.02|-415.90|0.0006
71136415|NCT04491136|141774721|OTHER||||||>|0.9999|||||||McNemar|||Occurrence of at least one shock||||>0.9999
71136416|NCT04491136|141774721|OTHER|||||||0.0654|||||||McNemar|||Occurrence of at least one ATP event||||0.0654
71136417|NCT00452790|141774748|SUPERIORITY_OR_OTHER|||||||0.483||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-any within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.483
71136418|NCT00452790|141774748|SUPERIORITY_OR_OTHER|||||||0.698||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-significant within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.698
70862977|NCT01675427|141212879|SUPERIORITY_OR_OTHER|||||||0.0145|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0145
70862978|NCT01675427|141212879|SUPERIORITY_OR_OTHER|||||||0.1027|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.1027
70862979|NCT01675427|141212879|SUPERIORITY_OR_OTHER|||||||0.5998|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5998
71136419|NCT00452790|141774748|SUPERIORITY_OR_OTHER|||||||0.782||95.0|||||Fisher Exact|||Difference in incidence rates of induration-any within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.782
71136420|NCT00452790|141774748|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of induration-mild within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
71136421|NCT00452790|141774748|SUPERIORITY_OR_OTHER|||||||0.729||95.0|||||Fisher Exact|||Difference in incidence rates of induration-moderate within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.729
71136422|NCT00452790|141774748|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of Induration-Severe within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
71136423|NCT00452790|141774748|SUPERIORITY_OR_OTHER|||||||0.819||95.0|||||Fisher Exact|||Difference in incidence rates of Erythema-Any within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.819
71136424|NCT00452790|141774748|SUPERIORITY_OR_OTHER|||||||0.904||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-mild within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.904
71136425|NCT00452790|141774748|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of Erythema-Moderate within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
71136426|NCT00452790|141774748|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-severe within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
71136427|NCT00452790|141774748|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Fisher Exact|||Difference in incidence rates of any local reaction (tenderness, induration and erythema) within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.690
71136428|NCT00452790|141774749|SUPERIORITY_OR_OTHER|||||||0.933||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-any within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.933
71136429|NCT00452790|141774749|SUPERIORITY_OR_OTHER|||||||0.776||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-significant within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.776
71136430|NCT00452790|141774749|SUPERIORITY_OR_OTHER|||||||0.596||95.0|||||Fisher Exact|||Difference in incidence rates of induration-any within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.596
71136431|NCT00452790|141774749|SUPERIORITY_OR_OTHER|||||||0.909||95.0|||||Fisher Exact|||Difference in incidence rates of induration-mild within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.909
71136432|NCT00452790|141774749|SUPERIORITY_OR_OTHER|||||||0.683||95.0|||||Fisher Exact|||Difference in incidence rates of induration-moderate within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.683
71136433|NCT00452790|141774749|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of induration-severe within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
71136434|NCT00452790|141774749|SUPERIORITY_OR_OTHER|||||||0.203||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-any within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.203
71136435|NCT00452790|141774749|SUPERIORITY_OR_OTHER|||||||0.399||95.0|||||Fisher Exact|||Difference in incidence rates of Erythema-Mild within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.399
71136436|NCT00452790|141774749|SUPERIORITY_OR_OTHER|||||||0.382||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-moderate within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.382
70862980|NCT01675427|141212879|SUPERIORITY_OR_OTHER|||||||0.2935|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2935
70862981|NCT01675427|141212879|SUPERIORITY_OR_OTHER|||||||0.0039|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0039
70862982|NCT01675427|141212880|SUPERIORITY_OR_OTHER|||||||0.1981|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.1981
70862983|NCT01675427|141212880|SUPERIORITY_OR_OTHER|||||||0.1616|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.1616
70862984|NCT01675427|141212880|SUPERIORITY_OR_OTHER|||||||0.1192|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.1192
70862985|NCT01675427|141212880|SUPERIORITY_OR_OTHER|||||||0.4485|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.4485
70862986|NCT01675427|141212880|SUPERIORITY_OR_OTHER|||||||0.1525|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.1525
70862987|NCT01675427|141212880|SUPERIORITY_OR_OTHER|||||||0.7262|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.7262
70862988|NCT01675427|141212881|SUPERIORITY_OR_OTHER|||||||0.0911|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0911
70862989|NCT01675427|141212881|SUPERIORITY_OR_OTHER|||||||0.4674|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.4674
70862990|NCT01675427|141212881|SUPERIORITY_OR_OTHER|||||||0.1604|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.1604
70862991|NCT01675427|141212881|SUPERIORITY_OR_OTHER|||||||0.5937|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5937
70862992|NCT01675427|141212881|SUPERIORITY_OR_OTHER|||||||0.383|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3830
70862993|NCT01675427|141212881|SUPERIORITY_OR_OTHER|||||||0.0507|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0507
70862994|NCT01675427|141212882|SUPERIORITY_OR_OTHER|||||||0.8686|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.8686
70862995|NCT01675427|141212882|SUPERIORITY_OR_OTHER|||||||0.3135|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.3135
70862996|NCT01675427|141212882|SUPERIORITY_OR_OTHER|||||||0.0578|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0578
70862997|NCT01675427|141212882|SUPERIORITY_OR_OTHER|||||||0.5833|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5833
71136437|NCT00452790|141774749|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-severe within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
70862998|NCT01675427|141212882|SUPERIORITY_OR_OTHER|||||||0.161|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.1610
70862999|NCT01675427|141212882|SUPERIORITY_OR_OTHER|||||||0.2925|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.2925
70863000|NCT01675427|141212883|SUPERIORITY_OR_OTHER|||||||0.3709|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.3709
70863001|NCT01675427|141212883|SUPERIORITY_OR_OTHER|||||||0.2054|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2054
70863002|NCT01675427|141212883|SUPERIORITY_OR_OTHER|||||||0.8457|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.8457
70863003|NCT01675427|141212883|SUPERIORITY_OR_OTHER|||||||0.3492|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.3492
70863004|NCT01675427|141212883|SUPERIORITY_OR_OTHER|||||||0.2846|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2846
70863005|NCT01675427|141212883|SUPERIORITY_OR_OTHER|||||||0.2646|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.2646
70863006|NCT01675427|141212884|SUPERIORITY_OR_OTHER|||||||0.5348|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.5348
70863007|NCT01675427|141212884|SUPERIORITY_OR_OTHER|||||||0.5469|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.5469
70863008|NCT01675427|141212884|SUPERIORITY_OR_OTHER|||||||0.0463|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0463
70863009|NCT01675427|141212884|SUPERIORITY_OR_OTHER|||||||0.9393|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.9393
70863010|NCT01675427|141212884|SUPERIORITY_OR_OTHER|||||||0.3404|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3404
70863011|NCT01675427|141212884|SUPERIORITY_OR_OTHER|||||||0.4237|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.4237
70863012|NCT01675427|141212885|SUPERIORITY_OR_OTHER|||||||0.251|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.2510
70863013|NCT01675427|141212885|SUPERIORITY_OR_OTHER|||||||0.2943|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2943
70863014|NCT01675427|141212885|SUPERIORITY_OR_OTHER|||||||0.0478|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0478
70863015|NCT01675427|141212885|SUPERIORITY_OR_OTHER|||||||0.5387|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5387
70863016|NCT01675427|141212885|SUPERIORITY_OR_OTHER|||||||0.3878|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3878
70863017|NCT01675427|141212885|SUPERIORITY_OR_OTHER|||||||0.0748|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0748
70863018|NCT01675427|141212886|SUPERIORITY_OR_OTHER|||||||0.9887|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.9887
70863019|NCT01675427|141212886|SUPERIORITY_OR_OTHER|||||||0.5507|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.5507
70863020|NCT01675427|141212886|SUPERIORITY_OR_OTHER|||||||0.0175|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0175
70863021|NCT01675427|141212886|SUPERIORITY_OR_OTHER|||||||0.2246|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.2246
70863022|NCT01675427|141212886|SUPERIORITY_OR_OTHER|||||||0.3519|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3519
70863023|NCT01675427|141212886|SUPERIORITY_OR_OTHER|||||||0.714|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.7140
70863024|NCT01675427|141212887|SUPERIORITY_OR_OTHER|||||||0.8622|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.8622
70863025|NCT01675427|141212887|SUPERIORITY_OR_OTHER|||||||0.1622|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.1622
70948047|NCT00267098|141396962|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|3.334|||||TWO_SIDED|95.0|1.886|4.815||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead, a posterior distribution representing the set of possible values for the BiV - RV difference in improvement in LVEF through 6 months was used|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEF change through 6 months.|"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEF from randomization to 6 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEF from randomization to 6 months than patients with right ventricular pacing."||4.815|1.886|
71136438|NCT00452790|141774749|SUPERIORITY_OR_OTHER|||||||0.738||95.0|||||Fisher Exact|||Difference in incidence rates of any Local reaction (tenderness, induration, erythema) within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.738
70863026|NCT01675427|141212887|SUPERIORITY_OR_OTHER|||||||0.2566|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.2566
70863027|NCT01675427|141212887|SUPERIORITY_OR_OTHER|||||||0.1574|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.1574
70863028|NCT01675427|141212887|SUPERIORITY_OR_OTHER|||||||0.5784|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.5784
70863029|NCT01675427|141212887|SUPERIORITY_OR_OTHER|||||||0.6603|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.6603
70863030|NCT01675427|141212888|SUPERIORITY_OR_OTHER|||||||0.0605|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0605
70863031|NCT01675427|141212888|SUPERIORITY_OR_OTHER|||||||0.0899|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0899
70863032|NCT01675427|141212888|SUPERIORITY_OR_OTHER|||||||0.0634|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0634
70863033|NCT01675427|141212888|SUPERIORITY_OR_OTHER|||||||0.6165|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.6165
70863034|NCT01675427|141212888|SUPERIORITY_OR_OTHER|||||||0.1649|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.1649
70863035|NCT01675427|141212888|SUPERIORITY_OR_OTHER|||||||0.9159|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.9159
70863036|NCT01675427|141212889|SUPERIORITY_OR_OTHER|||||||0.7454|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.7454
70863037|NCT01675427|141212889|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0016
70863038|NCT01675427|141212889|SUPERIORITY_OR_OTHER|||||||0.5261|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.5261
71136439|NCT00452790|141774750|SUPERIORITY_OR_OTHER|||||||0.918||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-any within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.918
71136440|NCT00452790|141774750|SUPERIORITY_OR_OTHER|||||||0.906||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-significant within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.906
71136441|NCT00452790|141774750|SUPERIORITY_OR_OTHER|||||||0.404||95.0|||||Fisher Exact|||Difference in incidence rates of induration-any within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.404
71136442|NCT00452790|141774750|SUPERIORITY_OR_OTHER|||||||0.305||95.0|||||Fisher Exact|||Difference in incidence rates of induration-mild within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.305
71136443|NCT00452790|141774750|SUPERIORITY_OR_OTHER|||||||0.771||95.0|||||Fisher Exact|||Difference in incidence rates of induration-moderate within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.771
71136444|NCT00452790|141774750|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of induration-severe within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
71136445|NCT00452790|141774750|SUPERIORITY_OR_OTHER|||||||0.867||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-any within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.867
71136446|NCT00452790|141774750|SUPERIORITY_OR_OTHER|||||||0.735||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-mild within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.735
71136447|NCT00452790|141774750|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-moderate within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
71136448|NCT00452790|141774750|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-severe within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
71136449|NCT00452790|141774750|SUPERIORITY_OR_OTHER|||||||0.842||95.0|||||Fisher Exact|||Difference in incidence rates of any Local Reaction (tenderness, induration, erythema) within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.842
71136450|NCT00452790|141774751|SUPERIORITY_OR_OTHER|||||||0.908||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-any within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.908
71136451|NCT00452790|141774751|SUPERIORITY_OR_OTHER|||||||0.772||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-significant within 4 days of the toddler dose, dose 4(12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.772
71136452|NCT00452790|141774751|SUPERIORITY_OR_OTHER|||||||0.681||95.0|||||Fisher Exact|||Difference in incidence rates of induration-any within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.681
71136453|NCT00452790|141774751|SUPERIORITY_OR_OTHER|||||||0.881||95.0|||||Fisher Exact|||Difference in incidence rates of induration-mild within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.881
71136454|NCT00452790|141774751|SUPERIORITY_OR_OTHER|||||||0.509||95.0|||||Fisher Exact|||Difference in incidence rates of induration-moderate within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.509
71136455|NCT00452790|141774751|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of induration-severe within 4 days of the toddler dose (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
71136456|NCT00452790|141774751|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-any within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.880
70863039|NCT01675427|141212889|SUPERIORITY_OR_OTHER|||||||0.3422|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.3422
71136457|NCT00452790|141774751|SUPERIORITY_OR_OTHER|||||||0.739||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-mild within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.739
70863040|NCT01675427|141212889|SUPERIORITY_OR_OTHER|||||||0.9026|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.9026
70863041|NCT01675427|141212890|SUPERIORITY_OR_OTHER|||||||0.0017|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0017
70863042|NCT01675427|141212890|SUPERIORITY_OR_OTHER|||||||0.8864|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.8864
70863043|NCT01675427|141212890|SUPERIORITY_OR_OTHER|||||||0.0291|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0291
70863044|NCT01675427|141212890|SUPERIORITY_OR_OTHER|||||||0.5472|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5472
71136458|NCT00452790|141774751|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-moderate within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
71136459|NCT00452790|141774751|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-severe within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
71136460|NCT00452790|141774751|SUPERIORITY_OR_OTHER|||||||0.446||95.0|||||Fisher Exact|||Difference in incidence rates of any local reaction (tenderness, induration, erythema) within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.446
71136461|NCT00452790|141774752|SUPERIORITY_OR_OTHER|||||||0.625||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>=38 but \<=39 degrees C within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.625
71136462|NCT00452790|141774752|SUPERIORITY_OR_OTHER|||||||0.375||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>39 but \<=40 degrees C within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.375
71136463|NCT00452790|141774752|SUPERIORITY_OR_OTHER|||||||0.624||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>40 degrees C within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.624
71136464|NCT00452790|141774752|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of decreased appetite within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
70863045|NCT01675427|141212890|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||1.000
71136465|NCT00452790|141774752|SUPERIORITY_OR_OTHER|||||||0.282||95.0|||||Fisher Exact|||Difference in incidence rates of irritability within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.282
70863046|NCT01675427|141212890|SUPERIORITY_OR_OTHER|||||||0.1148|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.1148
70863047|NCT01675427|141212891|SUPERIORITY_OR_OTHER|||||||0.4207|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.4207
70863048|NCT01675427|141212891|SUPERIORITY_OR_OTHER|||||||0.0566|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0566
70863049|NCT01675427|141212891|SUPERIORITY_OR_OTHER|||||||0.1211|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.1211
70863050|NCT01675427|141212891|SUPERIORITY_OR_OTHER|||||||0.3772|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.3772
71136466|NCT00452790|141774752|SUPERIORITY_OR_OTHER|||||||0.307||95.0|||||Fisher Exact|||Difference in incidence rates of Increased sleep within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.307
71136467|NCT00452790|141774752|SUPERIORITY_OR_OTHER|||||||0.939||95.0|||||Fisher Exact|||Difference in incidence rates of decreased sleep within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.939
71136468|NCT00452790|141774752|SUPERIORITY_OR_OTHER|||||||0.085||95.0|||||Fisher Exact|||Difference in incidence rates of any systemic event (fever, decrease in appetite, irritability, increased or decreased sleep) within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.085
71136469|NCT00452790|141774753|SUPERIORITY_OR_OTHER|||||||0.111||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>= 38 but \<= 39 degrees C within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.111
71136470|NCT00452790|141774753|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>39 but \<= 40 degrees C within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
71136471|NCT00452790|141774753|SUPERIORITY_OR_OTHER|||||||0.488||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>40 degrees C within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.488
71136472|NCT00452790|141774753|SUPERIORITY_OR_OTHER|||||||0.736||95.0|||||Fisher Exact|||Difference in incidence rates of Decreased appetite within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.736
71136473|NCT00452790|141774753|SUPERIORITY_OR_OTHER|||||||0.856||95.0|||||Fisher Exact|||Difference in incidence rates of Irritability within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.856
71136474|NCT00452790|141774753|SUPERIORITY_OR_OTHER|||||||0.098||95.0|||||Fisher Exact|||Difference in incidence rates of Increased sleep within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.098
71136475|NCT00452790|141774753|SUPERIORITY_OR_OTHER|||||||0.034||95.0|||||Fisher Exact|||Difference in incidence rates of Decreased sleep within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.034
71136476|NCT00452790|141774753|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of Any systemic event (fever, decrease in appetite, irritability, increased or decreased sleep) within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
71136477|NCT00452790|141774754|SUPERIORITY_OR_OTHER|||||||0.085||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>= 38 but \<= 39 degrees C within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.085
71136478|NCT00452790|141774754|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>39 but \<= 40 degrees C within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
71136479|NCT00452790|141774754|SUPERIORITY_OR_OTHER|||||||0.489||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>40 degrees C within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.489
71136480|NCT00452790|141774754|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Fisher Exact|||Difference in incidence rates of decreased appetite within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.840
71136481|NCT00452790|141774754|SUPERIORITY_OR_OTHER|||||||0.605||95.0|||||Fisher Exact|||Difference in incidence rates of irritability within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.605
71136482|NCT00452790|141774754|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of increased sleep within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
71136483|NCT00452790|141774754|SUPERIORITY_OR_OTHER|||||||0.265||95.0|||||Fisher Exact|||Difference in incidence rates of decreased sleep within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.265
71136484|NCT00452790|141774754|SUPERIORITY_OR_OTHER|||||||0.422||95.0|||||Fisher Exact|||Difference in incidence rates of any systemic event (fever, decrease in appetite, irritability, increased or decreased sleep) within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.422
71136485|NCT00452790|141774755|SUPERIORITY_OR_OTHER|||||||0.815||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>= 38 but \<= 39 degrees within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.815
71136486|NCT00452790|141774755|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>39 but \<= 40 degrees within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
70954409|NCT05126563|141411470|SUPERIORITY||LS Means|-0.172|STANDARD_ERROR_OF_MEAN|0.685||0.8021|TWO_SIDED|95.0|-1.54|1.2|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Brain fog scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.20|-1.54|0.8021
70863051|NCT01675427|141212891|SUPERIORITY_OR_OTHER|||||||0.4023|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.4023
70863052|NCT01675427|141212892|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
70863053|NCT01675427|141212892|SUPERIORITY_OR_OTHER|||||||0.2132|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2132
71136487|NCT00452790|141774755|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>40 degrees C within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
71136488|NCT00452790|141774755|SUPERIORITY_OR_OTHER|||||||0.401||95.0|||||Fisher Exact|||Difference in incidence rates of decreased appetite within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.401
71136489|NCT00452790|141774755|SUPERIORITY_OR_OTHER|||||||0.511||95.0|||||Fisher Exact|||Difference in incidence rates of irritability within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.511
71136490|NCT00452790|141774755|SUPERIORITY_OR_OTHER|||||||0.487||95.0|||||Fisher Exact|||Difference in incidence rates of increased sleep within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.487
71136491|NCT00452790|141774755|SUPERIORITY_OR_OTHER|||||||0.388||95.0|||||Fisher Exact|||Difference in incidence rates of decreased sleep within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.388
71136492|NCT00452790|141774755|SUPERIORITY_OR_OTHER|||||||0.753||95.0|||||Fisher Exact|||Difference in incidence rates of any systemic event fever, decrease in appetite, irritability, increased or decreased sleep) within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.753
71136493|NCT01712204|141774772|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81|STANDARD_ERROR_OF_MEAN|0.113||0.1356|TWO_SIDED|95.0|0.62|1.07|||Possion regression|||||1.07|0.62|0.1356
71136494|NCT02781610|141774782|NON_INFERIORITY|The non-inferiority margin is -3.5%.|Mean Difference (Final Values)|-0.7||||0.0164|TWO_SIDED|95.0|-3.3|2.0|||ANOVA|Adjusted for four dichotomous randomization strata.||The ERR non-inferiority test was a priori designed to be conducted on the per-protocol (PP) population for 93% power assuming 2-sided alpha=0.05 with 155 PP participants per arm. Difference between ERR treatment duration arms is ERR-10 - ERR-14.||2.0|-3.3|0.0164
71136495|NCT02781610|141774783|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.568|TWO_SIDED|95.0|-1.3|1.1|||ANOVA|Adjusted for four dichotomous randomization strata.||The NERR superiority test was a priori designed to be conducted on the Intent-to-Treat (ITT) population for 91% power to detect a 2.5% difference, assuming 2-sided alpha=0.05 with 285 ITT participants per arm. Difference between NERR treatment duration arms is NERR-21 - NERR-14.||1.1|-1.3|0.568
71136496|NCT02781610|141774784|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.546|TWO_SIDED|95.0|-2.4|4.6|||t-test, 2 sided|||Difference between ERR treatment duration arms is ERR-10 - ERR-14.||4.6|-2.4|0.546
71136497|NCT02781610|141774785|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.14|TWO_SIDED|95.0|-3.7|0.5|||t-test, 2 sided|||Difference between NERR treatment duration arms is NERR-21 - NERR-14.||0.5|-3.7|0.140
71136498|NCT02781610|141774786|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.563|TWO_SIDED|95.0|-0.42|0.77|||t-test, 2 sided|||Difference between ERR treatment duration arms is ERR-10 - ERR-14.||0.77|-0.42|0.563
71136499|NCT02781610|141774787|SUPERIORITY|Difference between NERR treatment duration arms is NERR-21 - NERR-14.|Mean Difference (Final Values)|0.29||||0.083|TWO_SIDED|95.0|-0.04|0.61|||t-test, 2 sided|||||0.61|-0.04|0.083
71136500|NCT00549445|141774819|OTHER|Student t test||||||0.045||||||Threshold for significance is P-Value \< 0.05|t-test, 1 sided|||||||0.045
71136501|NCT04437485|141774820|SUPERIORITY|||||||0.64|||||||ANCOVA|ANCOVA models were run on post-treatment outcome level adjusting for baseline somatic depressive symptoms group (a stratification variable).||||||0.64
71136502|NCT04437485|141774821|SUPERIORITY|||||||0.046|||||||ANCOVA|ANCOVA models were run on post-treatment outcome level adjusting for baseline somatic depressive symptoms group (a stratification variable).||||||0.046
71136503|NCT04437485|141774822|SUPERIORITY|||||||0.09|||||||ANCOVA|ANCOVA models were run on post-treatment outcome level adjusting for baseline somatic depressive symptoms group (a stratification variable).||||||0.09
71136504|NCT05736874|141774954|SUPERIORITY|Decision rule based on Bayesian posterior probability of efficacy. The decision threshold was a posterior probability of 0.95. A prespecified skeptical prior for the treatment effect was used to preserve type I error below 0.05.|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.91|1.12|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.12|0.91|
71136505|NCT05736874|141774955|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.19|4.68|||||Descriptive analysis is a maximum partial likelihood proportional hazards regression model. Low event rate precluded covariate adjustment.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||4.68|0.19|
70863054|NCT01675427|141212892|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||< 0.0001
70948048|NCT00267098|141396963|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|3.232|||||TWO_SIDED|95.0|1.618|4.839||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead, a posterior distribution representing the set of possible values for the BiV - RV difference in improvement in LVEF through 12 months was used|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEF change through 12 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEF from randomization to 12 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEF from randomization to 12 months than patients with right ventricular pacing.||4.839|1.618|
70948049|NCT00267098|141396964|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|2.24|||||TWO_SIDED|95.0|0.419|4.066||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead, a posterior distribution representing the set of possible values for the BiV - RV difference in improvement in LVEF at 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEF change through 18 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEF from randomization to 18 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEF from randomization to 18 months than patients with right ventricular pacing.||4.066|0.419|
70863055|NCT01675427|141212892|SUPERIORITY_OR_OTHER|||||||0.3031|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.3031
70863056|NCT01675427|141212892|SUPERIORITY_OR_OTHER|||||||0.955|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.9550
70863057|NCT01675427|141212892|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
70863058|NCT01675427|141212893|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
70863059|NCT01675427|141212893|SUPERIORITY_OR_OTHER|||||||0.189|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.1890
71136506|NCT05736874|141774958|SUPERIORITY|Statistical analysis was a Bayesian proportional hazards regression model with covariate adjustment and weakly informative priors.|Hazard Ratio (HR)|1.9|||||TWO_SIDED|95.0|0.8|3.5|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||3.5|0.8|
71136507|NCT05736874|141774959|SUPERIORITY|Statistical analysis was a Bayesian cumulative probability ordinal regression model with covariate adjustment and weakly informative priors.|Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.62|1.63|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||1.63|0.62|
71136508|NCT05736874|141774960|SUPERIORITY|Statistical analysis was a Bayesian cumulative probability ordinal regression model with covariate adjustment and weakly informative priors.|Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.42|1.5|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||1.50|0.42|
71136509|NCT05736874|141774961|SUPERIORITY|Statistical analysis was a Bayesian cumulative probability ordinal regression model with covariate adjustment and weakly informative priors|Odds Ratio (OR)|2.74|||||TWO_SIDED|95.0|0.5|5.94|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||5.94|0.50|
71136510|NCT05736874|141774962|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.69|1.11|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.11|0.69|
71136511|NCT05736874|141774962|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.78|1.34|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.34|0.78|
71136512|NCT05736874|141774962|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.78|1.45|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.45|0.78|
71136513|NCT05736874|141774962|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.79|1.53|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.53|0.79|
71136514|NCT05736874|141774963|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.72|1.09|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.09|0.72|
70863060|NCT01675427|141212893|SUPERIORITY_OR_OTHER|||||||0.5793|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.5793
71136515|NCT05736874|141774963|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.84|1.27|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.27|0.84|
71136516|NCT05736874|141774963|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.76|1.2|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.20|0.76|
71136517|NCT05736874|141774963|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.84|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.32|0.84|
71136518|NCT05736874|141774964|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.74|||||TWO_SIDED|95.0|0.58|0.93|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||0.93|0.58|
71136519|NCT05736874|141774964|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.76|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.32|0.76|
70863061|NCT01675427|141212893|SUPERIORITY_OR_OTHER|||||||0.0847|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.0847
70954410|NCT05126563|141411471|SUPERIORITY||LS Means|0.399|STANDARD_ERROR_OF_MEAN|0.515||0.4417|TWO_SIDED|95.0|-0.63|1.43|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms. - Headache scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.43|-0.63|0.4417
71136520|NCT05736874|141774964|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.94|||||TWO_SIDED|95.0|0.71|1.25|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.25|0.71|
71136521|NCT05736874|141774964|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.21|||||TWO_SIDED|95.0|0.89|1.64|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.64|0.89|
70863062|NCT01675427|141212893|SUPERIORITY_OR_OTHER|||||||0.5506|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.5506
71136522|NCT05736874|141774965|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.7|1.15|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.15|0.70|
71136523|NCT05736874|141774965|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.75|1.29|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.29|0.75|
70954411|NCT05126563|141411472|SUPERIORITY||Slope|0.542|STANDARD_ERROR_OF_MEAN|0.721||0.455|TWO_SIDED|95.0|-0.9|1.98|||ANCOVA|||The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Sleep disturbances scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.98|-0.90|0.4550
71136524|NCT05736874|141774965|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.72|1.26|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.26|0.72|
71136525|NCT05736874|141774965|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.92|1.61|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.61|0.92|
71136526|NCT05736874|141774966|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.81|1.28|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.28|0.81|
71136527|NCT05736874|141774966|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.6|0.99|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||0.99|0.60|
71136528|NCT05736874|141774966|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.74|1.23|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.23|0.74|
71136529|NCT05736874|141774966|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.89|1.5|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.50|0.89|
71136530|NCT05736874|141774967|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.69|1.06|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.06|0.69|
71136531|NCT05736874|141774967|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.82|1.3|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.30|0.82|
71136532|NCT05736874|141774967|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.8|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.32|0.80|
71136533|NCT05736874|141774967|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.75|1.29|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.29|0.75|
71136534|NCT05736874|141774968|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.62|0.93|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||0.93|0.62|
71136535|NCT05736874|141774968|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.78|1.18|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.18|0.78|
71136536|NCT05736874|141774968|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.74|1.12|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.12|0.74|
71136537|NCT05736874|141774968|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|1.02|1.56|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.56|1.02|
71136538|NCT05736874|141774969|SUPERIORITY||Difference in model estimate time unwell|-0.1|||||TWO_SIDED|95.0|-0.45|0.26|||||The interval is a highest-density credible interval.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||0.26|-0.45|
71136539|NCT05736874|141774970|SUPERIORITY||Difference in model estimated means|0.13|||||TWO_SIDED|95.0|-0.28|0.58|||||The interval is a highest-density credible interval.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||0.58|-0.28|
71136540|NCT03057496|141774974|SUPERIORITY||Rate ratio|0.627|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|0.536|0.734||Since the outcome (contacts) represented over-dispersed count data and there were repeated measurements per subject, a generalized mixed effects model with a negative binomial family was used with each subject treated as a random intercept.|Mixed Models Analysis|Fixed factors were included in the model to account for factors other than device operating mode that might affect collision rates.|Silent mode is the denominator for the rate ratio.|A within-subject comparison was performed. Each subject included in the analysis used the device in both the active and the silent mode. Comparison was between the two device operating modes. The null hypothesis was that there was no difference in the rate of contacts between active and silent modes.||0.734|0.536|< 0.001
71136541|NCT01307319|141774980|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.63|||<|0.001|TWO_SIDED|95.0|-1.0|-0.3||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.3|-1.0|<0.001
71136542|NCT01307319|141774980|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.73|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.4|-1.1|<0.001
71136543|NCT01307319|141774981|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.71|||<|0.001|TWO_SIDED|95.0|-1.1|-0.3||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||The power calculation assumed the standard deviation (SD) for the change from baseline over two weeks in the average of AM and PM reflective TNSS is assumed to be 2.0. Using this standard deviation, 235 subjects per arm provides 90% power to detect a difference of 0.60 in TNSS change from baseline between treatment groups with a two-sided alpha level of 0.05.||-0.3|-1.1|<0.001
71136544|NCT01307319|141774981|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.76|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.4|-1.1|<0.001
71136545|NCT00411749|141775018|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71136546|NCT00411749|141775019|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71136547|NCT00411749|141775020|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71136548|NCT00411749|141775021|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71136549|NCT00411749|141775022|SUPERIORITY_OR_OTHER||Geometric Mean|155.2|||||TWO_SIDED|95.0|126.2|190.9||||||||190.9|126.2|
71136550|NCT00411749|141775022|SUPERIORITY_OR_OTHER||Geometric Mean|198.2|||||TWO_SIDED|95.0|160.9|244.2||||||||244.2|160.9|
71136551|NCT00411749|141775022|SUPERIORITY_OR_OTHER||Geometric Mean|617.1|||||TWO_SIDED|95.0|491.7|774.5||||||||774.5|491.7|
71136552|NCT00411749|141775022|SUPERIORITY_OR_OTHER||Geometric Mean|90.0|||||TWO_SIDED|95.0|68.8|117.8||||||||117.8|68.8|
71136553|NCT00964496|141775032|SUPERIORITY_OR_OTHER||Differences in proportions|0.677||||1.3e-07|TWO_SIDED|95.0|0.547|0.807||P\<0.05 was considered as statistical different, while P\>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|Fisher Exact|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the participants whose rebleeds decreased from baseline by ≥ 50% at 12 months.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the participants whose rebleeds decreased from baseline by ≥ 50% at 12 months.~Comparisons were performed with the use of the chi-square test, Fisher's exact test."||0.807|0.547|0.00000013
71136554|NCT00964496|141775033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.08|||<|0.001|TWO_SIDED|95.0|-4.02|-2.13||P\<0.05 was considered as statistical different, while P\>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|t-test, 2 sided|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the change from baseline in hemoglobin level at 12 months.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the change from baseline in hemoglobin level at 12 months.~Comparisons were performed with the use of the independent-samples t test."||-2.13|-4.02|<0.001
71136555|NCT00964496|141775034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.95|||<|0.01|TWO_SIDED|95.0|6.0|9.9||P\<0.05 was considered as statistical different, while P\>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|t-test, 2 sided|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the change from baseline in bleeding episodes at 12 months.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the change from baseline in bleeding episodes at 12 months.~Comparisons were performed with the use of the independent-samples t test."||9.90|6.00|<0.01
70863063|NCT01675427|141212893|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0020
70863064|NCT01675427|141212894|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0007
70863065|NCT01675427|141212894|SUPERIORITY_OR_OTHER|||||||0.0061|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0061
70863066|NCT01675427|141212894|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||< 0.0001
70863067|NCT01675427|141212894|SUPERIORITY_OR_OTHER|||||||0.3885|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.3885
70863068|NCT01675427|141212894|SUPERIORITY_OR_OTHER|||||||0.3597|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3597
70863069|NCT01675427|141212894|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
70863070|NCT01675427|141212895|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
70863071|NCT01675427|141212895|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0005
70863072|NCT01675427|141212895|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0110
70863073|NCT01675427|141212895|SUPERIORITY_OR_OTHER|||||||0.098|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.0980
70863074|NCT01675427|141212895|SUPERIORITY_OR_OTHER|||||||0.2264|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2264
70863075|NCT01675427|141212895|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
70863076|NCT01675427|141212896|SUPERIORITY_OR_OTHER|||||||0.0098|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0098
70863077|NCT01675427|141212896|SUPERIORITY_OR_OTHER|||||||0.6291|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.6291
70863078|NCT01675427|141212896|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0013
70863079|NCT01675427|141212896|SUPERIORITY_OR_OTHER|||||||0.5588|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5588
70863080|NCT01675427|141212896|SUPERIORITY_OR_OTHER|||||||0.9932|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.9932
70863081|NCT01675427|141212896|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
70863082|NCT01675427|141212897|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0007
70863083|NCT01675427|141212897|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0020
70863084|NCT01675427|141212897|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0013
70863085|NCT01675427|141212897|SUPERIORITY_OR_OTHER|||||||0.7166|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.7166
70863086|NCT01675427|141212897|SUPERIORITY_OR_OTHER|||||||0.3217|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3217
70863087|NCT01675427|141212897|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
70863088|NCT01675427|141212898|SUPERIORITY_OR_OTHER|||||||0.1894|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.1894
70863089|NCT01675427|141212898|SUPERIORITY_OR_OTHER|||||||0.0054|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0054
70863090|NCT01675427|141212898|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||< 0.0001
70863091|NCT01675427|141212898|SUPERIORITY_OR_OTHER|||||||0.536|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5360
70863092|NCT01675427|141212898|SUPERIORITY_OR_OTHER|||||||0.2185|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2185
70863093|NCT01675427|141212898|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
70863094|NCT01675427|141212899|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0002
70863095|NCT01675427|141212899|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0003
70863096|NCT01675427|141212899|SUPERIORITY_OR_OTHER|||||||0.0106|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0106
70863097|NCT01675427|141212899|SUPERIORITY_OR_OTHER|||||||0.7821|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.7821
70863098|NCT01675427|141212899|SUPERIORITY_OR_OTHER|||||||0.2372|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2372
70863099|NCT01675427|141212899|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
70863100|NCT01675427|141212900|SUPERIORITY_OR_OTHER|||||||0.0688|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0688
70863101|NCT01675427|141212900|SUPERIORITY_OR_OTHER|||||||0.4367|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.4367
70863102|NCT01675427|141212900|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||< 0.0001
70863103|NCT01675427|141212900|SUPERIORITY_OR_OTHER|||||||0.1951|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.1951
70863104|NCT01675427|141212900|SUPERIORITY_OR_OTHER|||||||0.2927|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2927
70863105|NCT01675427|141212900|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0013
70863106|NCT01675427|141212901|SUPERIORITY_OR_OTHER|||||||0.0247|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0247
70863107|NCT01675427|141212901|SUPERIORITY_OR_OTHER|||||||0.0034|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0034
70863108|NCT01675427|141212901|SUPERIORITY_OR_OTHER|||||||0.0017|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0017
70863109|NCT01675427|141212901|SUPERIORITY_OR_OTHER|||||||0.3346|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.3346
70863110|NCT01675427|141212901|SUPERIORITY_OR_OTHER|||||||0.3215|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3215
70863111|NCT01675427|141212901|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0003
70863112|NCT01675427|141212902|SUPERIORITY_OR_OTHER|||||||0.3609|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.3609
70863113|NCT01675427|141212902|SUPERIORITY_OR_OTHER|||||||0.0018|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0018
71136556|NCT00964496|141775035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4||||0.0002474|TWO_SIDED|95.0|2.15|6.64||P\<0.05 was considered as statistical different, while P\>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|t-test, 2 sided|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the change from baseline in bleeding duration at 12 months.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the change from baseline in bleeding duration at 12 months.~Comparisons were performed with the use of the independent-samples t test."||6.64|2.15|0.00024740
71136557|NCT00964496|141775036|SUPERIORITY_OR_OTHER||Differences in proportions|-0.374||||0.00298881|TWO_SIDED|95.0|-0.563|-0.185||P\<0.05 was considered as statistical different, while P\>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|Fisher Exact|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the participants dependent on blood transfusions.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the participants dependent on blood transfusions.~Comparisons were performed with the use of the chi-square test, Fisher's exact test."||-0.185|-0.563|0.00298881
71136558|NCT00964496|141775037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1557.14|||<|0.01|TWO_SIDED|95.0|1294.53|1819.76||P\<0.05 was considered as statistical different, while P\>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|t-test, 2 sided|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the change from baseline in total transfused red cell requirements at 12 months.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the change from baseline in total transfused red cell requirements at 12 months.~Comparisons were performed with the use of the independent-samples t test."||1819.76|1294.53|<0.01
71136559|NCT00964496|141775038|SUPERIORITY_OR_OTHER||Differences in proportions|0.464||||3.962e-05|TWO_SIDED|95.0|0.28|0.649|||Fisher Exact|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the cessation of bleeding.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the cessation of bleeding.~Comparisons were performed with the use of the chi-square test, Fisher's exact test."||0.649|0.28|0.00003962
71136560|NCT01147666|141775085|OTHER|||||||1||||||Threshold for significance at 0.05 level.|Fisher Exact|||||||1.0000
71136561|NCT01147666|141775085|OTHER|||||||0.0698||||||Threshold for significance at 0.05 level.|Fisher Exact|||||||0.0698
71136562|NCT01147666|141775085|OTHER|||||||0.1534||||||Threshold for significance at 0.05 level.|Fisher Exact|||||||0.1534
71136563|NCT01147666|141775085|OTHER|||||||0.2657||||||Threshold for significance at 0.05 level.|Fisher Exact|||||||0.2657
71136564|NCT01147666|141775086|OTHER|||||||1||||||Threshold for significance at 0.05 level.|Fisher Exact|||||||1.0000
71136565|NCT01135134|141775112|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71136566|NCT01135134|141775113|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71136567|NCT03246789|141775256|SUPERIORITY||Mean Difference (Final Values)|2.15||||0.31|TWO_SIDED|95.0|-2.09|6.39|||t-test, 2 sided|||Week 12||6.39|-2.09|0.31
71136568|NCT03246789|141775257|SUPERIORITY||Mean Difference (Final Values)|-1.47||||0.28|TWO_SIDED|95.0|-4.22|1.28|||t-test, 2 sided|||Domain #1, Week 12||1.28|-4.22|0.28
71136569|NCT03246789|141775257|SUPERIORITY||Mean Difference (Final Values)|-0.87||||0.5|TWO_SIDED|95.0|-3.48|1.74|||t-test, 2 sided|||Domain #2, Week 12||1.74|-3.48|0.50
71136570|NCT03246789|141775257|SUPERIORITY||Mean Difference (Final Values)|-1.58||||0.02|TWO_SIDED|95.0|-2.88|-0.28|||t-test, 2 sided|||Domain #3, Week 12||-0.28|-2.88|0.02
71136571|NCT03246789|141775257|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.98|TWO_SIDED|95.0|-3.63|3.53|||t-test, 2 sided|||Domain 4, Week 12||3.53|-3.63|0.98
71136572|NCT03246789|141775258|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.92|TWO_SIDED|95.0|-0.64|0.58|||t-test, 2 sided|||Domain #1, Week 12||0.58|-0.64|0.92
71136573|NCT03246789|141775258|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.48|TWO_SIDED|95.0|-0.69|0.33|||t-test, 2 sided|||Domain #2, Week 12||0.33|-0.69|0.48
71136574|NCT03246789|141775258|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.48|TWO_SIDED|95.0|-0.33|0.69|||t-test, 2 sided|||||0.69|-0.33|0.48
71136575|NCT00945282|141775293|SUPERIORITY||Mean Difference (Final Values)|-0.932||||0.042|TWO_SIDED|95.0|-1.812|-0.053|||ANCOVA|||||-0.053|-1.812|0.042
71136576|NCT00945282|141775294|SUPERIORITY||Mean Difference (Final Values)|-0.413||||0.221|TWO_SIDED|95.0|-1.173|0.347|||ANCOVA|||||0.347|-1.173|0.221
71136577|NCT00945282|141775295|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value is the value for GSK2248761 30 mg, at Day 1 to Day 8|Mixed Models Analysis|||Day 1 to Day 8||||<0.0001
71136578|NCT00945282|141775295|SUPERIORITY_OR_OTHER|||||||0.6922||||||The p-value is the value for placebo, at Day 1 to Day 8|Mixed Models Analysis|||Placebo, Day 1 to Day 8||||0.6922
71136579|NCT03101566|141775311|OTHER||||||||||||||||||PFS at 6 months was estimated for this trial using the product-limit method of Kaplan and Meier with 95% confidence intervals calculated using Greenwood's formula. All statistical analyses were completed using the SAS System, v9.4 \[Cary, NC, USA\].|||
71136580|NCT02109640|141775338|SUPERIORITY_OR_OTHER||Absolute percentage difference|17.1||||0.264|TWO_SIDED|95.0|-10.0|40.7||Absolute % difference 17.1 (95% CI -10.0,40.7)|Fisher Exact|||||40.7|-10.0|0.264
71136581|NCT02109640|141775339|SUPERIORITY_OR_OTHER|||||||0.222|||||||t-test, 2 sided|||||||0.222
70863114|NCT01675427|141212902|SUPERIORITY_OR_OTHER|||||||0.0356|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0356
70863115|NCT01675427|141212902|SUPERIORITY_OR_OTHER|||||||0.7044|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.7044
70863116|NCT01675427|141212902|SUPERIORITY_OR_OTHER|||||||0.8578|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.8578
70863117|NCT01675427|141212902|SUPERIORITY_OR_OTHER|||||||0.0076|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0076
70954412|NCT05126563|141411473|SUPERIORITY||LS Means|-0.047|STANDARD_ERROR_OF_MEAN|0.466||0.92|TWO_SIDED|95.0|-0.98|0.89|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Loss of taste scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.89|-0.98|0.9200
70954413|NCT05126563|141411474|SUPERIORITY||LS Means|-0.16|STANDARD_ERROR_OF_MEAN|0.36||0.6589|TWO_SIDED|95.0|-0.88|0.56|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in PHQ-9 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.56|-0.88|0.6589
71136582|NCT02109640|141775340|SUPERIORITY_OR_OTHER|||||||0.676|||||||t-test, 2 sided|||||||0.676
70863118|NCT01675427|141212903|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0002
70863119|NCT01675427|141212903|SUPERIORITY_OR_OTHER|||||||0.2017|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2017
70863120|NCT01675427|141212903|SUPERIORITY_OR_OTHER|||||||0.5878|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.5878
70863121|NCT01675427|141212903|SUPERIORITY_OR_OTHER|||||||0.4144|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.4144
71136583|NCT02230566|141775341|SUPERIORITY||LS Mean|-64.82|||<|0.0001|TWO_SIDED|95.0|-69.66|-59.98||P-values are from GEE model including baseline value, and the post UX003 Treatment Week as a categorical variable. The covariance structure within participants was assumed to be exchangeable.|GEE|||||-59.98|-69.66|< 0.0001
71136584|NCT02230566|141775342|SUPERIORITY|||||||0.0527|||||||t-test|"P value from t-test of no change (0 change) from baseline"||||||0.0527
71136585|NCT02230566|141775343|SUPERIORITY||LS Mean|20.8||||0.2137|TWO_SIDED|95.0|-12.0|53.7||P-values are from GEE model including baseline value, and the post UX003 Treatment Week as a categorical variable. The covariance structure within participants was assumed to be exchangeable.|GEE|||||53.7|-12.0|0.2137
71136586|NCT02230566|141775346|SUPERIORITY||LS Mean|-6.5||||0.1778|TWO_SIDED|95.0|-16.1|3.0|||GEE|||Shoulder Flexion - Left||3.0|-16.1|0.1778
71136587|NCT02230566|141775346|SUPERIORITY||LS Mean|-1.5||||0.7632|TWO_SIDED|95.0|-10.9|8.0|||GEE|||Shoulder Extension - Left||8.0|-10.9|0.7632
71136588|NCT02230566|141775346|SUPERIORITY||LS Mean|-1.8||||0.6034|TWO_SIDED|95.0|-8.8|5.1|||GEE|||Shoulder Flexion - Right||5.1|-8.8|0.6034
70863122|NCT01675427|141212903|SUPERIORITY_OR_OTHER|||||||0.4492|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.4492
70863123|NCT01675427|141212903|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
70863124|NCT01675427|141212904|SUPERIORITY_OR_OTHER|||||||0.0671|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0671
70863125|NCT01675427|141212904|SUPERIORITY_OR_OTHER|||||||0.1009|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.1009
70863126|NCT01675427|141212904|SUPERIORITY_OR_OTHER|||||||0.0635|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0635
70863127|NCT01675427|141212904|SUPERIORITY_OR_OTHER|||||||0.4162|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.4162
70863128|NCT01675427|141212904|SUPERIORITY_OR_OTHER|||||||0.9305|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.9305
71136589|NCT02230566|141775346|SUPERIORITY||LS Mean|-3.4||||0.3332|TWO_SIDED|95.0|-10.2|3.4|||GEE|||Shoulder Extension - Right||3.4|-10.2|0.3332
71136590|NCT02230566|141775346|SUPERIORITY||LS Mean|-9.4||||0.0415|TWO_SIDED|95.0|-18.4|-0.4|||GEE|||Tighter Shoulder Flexion||-0.4|-18.4|0.0415
71136591|NCT02230566|141775346|SUPERIORITY||LS Mean|-6.7||||0.0563|TWO_SIDED|95.0|-13.6|0.2|||GEE|||Tighter Shoulder Extension||0.2|-13.6|0.0563
71136592|NCT02230566|141775347|SUPERIORITY||LS Mean|1.0||||0.114|TWO_SIDED|95.0|-0.2|2.2|||GEE|||for the left eye||2.2|-0.2|0.1140
71136593|NCT02230566|141775347|SUPERIORITY||LS Mean|0.9||||0.0906|TWO_SIDED|95.0|-0.1|1.8|||GEE|||for the right eye||1.8|-0.1|0.0906
71136594|NCT02230566|141775348|SUPERIORITY||LS Mean|0.8||||0.0883|TWO_SIDED|95.0|-0.1|1.7|||GEE|||Scale-BALANCE||1.7|-0.1|0.0883
71136595|NCT02230566|141775348|SUPERIORITY||LS Mean|-0.2||||0.3528|TWO_SIDED|95.0|-0.7|0.2|||GEE|||Scale: FINE MOTOR PRECISION||0.2|-0.7|0.3528
71136596|NCT02230566|141775348|SUPERIORITY||LS Mean|0.2||||0.4094|TWO_SIDED|95.0|-0.2|0.6|||GEE|||Scale-MANUAL DEXTERITY||0.6|-0.2|0.4094
71136597|NCT02230566|141775348|SUPERIORITY||LS Mean|0.2||||0.102|TWO_SIDED|95.0|0.0|0.4|||GEE|||Scale-RUNNING SPEED AND AGILITY||0.4|0.0|0.1020
71136598|NCT02230566|141775349|SUPERIORITY||LS Mean|3.4||||0.1953|TWO_SIDED|95.0|-1.8|8.6|||GEE|||||8.6|-1.8|0.1953
71136599|NCT02230566|141775351|SUPERIORITY||LS Mean|-1.2||||0.2022|TWO_SIDED|95.0|-3.0|0.6|||GEE|||||0.6|-3.0|0.2022
71136600|NCT03507036|141775366|OTHER||||||||||||||||||A paired t-test was performed for skin lab measurement and biopsies.|||
71136601|NCT04532034|141775383|OTHER||Mean Difference (Final Values)|0.067||||0.95|TWO_SIDED||||||t-test, 2 sided|||||||.95
71136602|NCT01236521|141775398|SUPERIORITY||Mean Difference (Net)|0.39|STANDARD_DEVIATION|0.13||0.0385|TWO_SIDED||||||Mixed Models Analysis|||||||0.0385
71136603|NCT01236521|141775399|SUPERIORITY||Mean Difference (Net)|0.44|STANDARD_DEVIATION|0.11||0.0067|TWO_SIDED||||||Mixed Models Analysis|||||||0.0067
71136604|NCT01236521|141775400|SUPERIORITY||Median Difference (Net)|0.39|STANDARD_DEVIATION|0.15||0.074|TWO_SIDED||||||Mixed Models Analysis|||||||0.0740
71136605|NCT02756572|141775425|OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
71136606|NCT02756572|141775426|OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
71136607|NCT02756572|141775427|OTHER|||||||0.049|||||||Fisher Exact|||||||0.049
71136608|NCT02756572|141775428|OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
71136609|NCT03628976|141775431|SUPERIORITY|||||||0.0096|||||||ANOVA|||||||0.0096
70863129|NCT01675427|141212904|SUPERIORITY_OR_OTHER|||||||0.0041|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0041
71136610|NCT03628976|141775432|SUPERIORITY|||||||0.764|||||||ANOVA|||||||0.764
71136611|NCT03628976|141775433|SUPERIORITY|||||||0.446|||||||ANOVA|||||||0.446
71136612|NCT03270943|141775455|SUPERIORITY|||||||0.02|||||||Log Rank|||||||0.02
71136613|NCT03270943|141775456|OTHER|within group|Mean Difference (Net)|-1.01|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-6.06|3.84|||||Difference between score at 8 weeks and score at baseline.|||3.84|-6.06|
71136614|NCT03270943|141775456|OTHER|within group|Mean Difference (Net)|-4.46|STANDARD_ERROR_OF_MEAN|2.05|||TWO_SIDED|95.0|-8.7|-0.22|||||Difference between score at 8 weeks and score at baseline.|||-0.22|-8.70|
71136615|NCT03270943|141775457|OTHER|within group change|Mean Difference (Net)|-0.64|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-2.72|0.2|||||Difference between score at 8 weeks and score at baseline.|||0.2|-2.72|
71136616|NCT03270943|141775457|OTHER|within group change|Mean Difference (Net)|-1.72|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|-3.6|0.16|||||Difference between score at 8 weeks and score at baseline.|||0.16|-3.60|
71136617|NCT03270943|141775458|OTHER|Within group change|Mean Difference (Net)|0.23|||||TWO_SIDED|95.0|-0.15|0.61|||||Difference between score at 8 weeks and score at baseline.|||0.61|-0.15|
71136618|NCT03270943|141775458|OTHER|within group change|Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.07|0.63|||||Difference between score at 8 weeks and score at baseline.|||0.63|0.07|
71136619|NCT02981368|141775472|SUPERIORITY|||||||0.1097|||||||Fisher Exact|||Tissue Site: Bone||||0.1097
71136620|NCT02981368|141775472|SUPERIORITY|||||||0.1087|||||||Fisher Exact|||Tissue Site: Bone||||0.1087
71136621|NCT02981368|141775472|SUPERIORITY|||||||0.1949|||||||Fisher Exact|||Tissue Site: Bone||||0.1949
71136622|NCT02981368|141775472|SUPERIORITY|||||||0.1315|||||||Fisher Exact|||Tissue Site: Bone||||0.1315
71136623|NCT02981368|141775472|SUPERIORITY|||||||0.1977|||||||Fisher Exact|||Tissue Site: Bone||||0.1977
71136624|NCT02981368|141775472|SUPERIORITY|||||||0.2149|||||||Fisher Exact|||Tissue Site: Bone||||0.2149
71136625|NCT02981368|141775472|SUPERIORITY|||||||0.2582|||||||Fisher Exact|||Tissue Site: Visceral/Soft tissue||||0.2582
71136626|NCT02981368|141775472|SUPERIORITY|||||||0.0009|||||||Fisher Exact|||Tissue Site: Visceral/Soft tissue||||0.0009
71136627|NCT02981368|141775472|SUPERIORITY|||||||0.3588|||||||Fisher Exact|||Tissue Site: Visceral/Soft tissue||||0.3588
70863130|NCT01675427|141212905|SUPERIORITY_OR_OTHER|||||||0.0059|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0059
71136628|NCT02981368|141775472|SUPERIORITY|||||||0.8791|||||||Fisher Exact|||Tissue Site: Visceral/Soft tissue||||0.8791
71136629|NCT02981368|141775472|SUPERIORITY|||||||0.9457|||||||Fisher Exact|||Tissue Site: Visceral/Soft tissue||||0.9457
71136630|NCT02981368|141775472|SUPERIORITY|||||||0.2705|||||||Fisher Exact|||Tissue Site: Visceral/Soft tissue||||0.2705
71136631|NCT02981368|141775472|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Type: Lymph nodes||||<0.0001
71136632|NCT02981368|141775472|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Type: Lymph nodes||||<0.0001
71136633|NCT02981368|141775472|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Type: Lymph nodes||||<0.0001
71136634|NCT02981368|141775472|SUPERIORITY|||||||0.5933|||||||Chi-squared|||Tissue Type: Lymph nodes||||0.5933
71136635|NCT02981368|141775472|SUPERIORITY|||||||0.7094|||||||Chi-squared|||Tissue Type: Lymph nodes||||0.7094
71136636|NCT02981368|141775472|SUPERIORITY|||||||0.5424|||||||Chi-squared|||Tissue Type: Lymph nodes||||0.5424
71136637|NCT02981368|141775472|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Site: Prostate Gland||||<0.0001
71136638|NCT02981368|141775472|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Tissue Site: Prostate Gland||||<0.0001
71136639|NCT02981368|141775472|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Tissue Site: Prostate Gland||||<0.0001
71136640|NCT02981368|141775472|SUPERIORITY|||||||0.0038|||||||Fisher Exact|||Tissue Site: Prostate Gland||||0.0038
71136641|NCT02981368|141775472|SUPERIORITY|||||||0.0647|||||||Fisher Exact|||Tissue Site: Prostate Gland||||0.0647
71136642|NCT02981368|141775472|SUPERIORITY|||||||0.0021|||||||Chi-squared|||Tissue Site: Prostate Gland||||0.0021
71136643|NCT02981368|141775472|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Site: All||||<0.0001
71136644|NCT02981368|141775472|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Site: All||||<0.0001
71136645|NCT02981368|141775472|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Site: All||||<0.0001
71136646|NCT02981368|141775472|SUPERIORITY|||||||0.0815|||||||Chi-squared|||Tissue Site: All||||0.0815
71136647|NCT02981368|141775472|SUPERIORITY|||||||0.7507|||||||Chi-squared|||Tissue Site: All||||0.7507
71136648|NCT02981368|141775472|SUPERIORITY|||||||0.562|||||||Chi-squared|||Tissue Site: All||||0.5620
71136649|NCT01584232|141775501|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 95% Confidence Interval (CI) was \<0.4%, then LY2189265 was declared non-inferior to insulin glargine. If the upper limit of the 95% CI was \<0.0%, then LY2189265 was declared superior to insulin glargine.|LS Mean Difference|-0.54|||<|0.001|TWO_SIDED|95.0|-0.67|-0.41||P-value is from the pairwise comparison of LS means using a mixed effects model with repeated measurements (MMRM).|Mixed Models Analysis|||Approximately 360 participants were to be randomized in a 1:1 ratio to LY2189265 or insulin glargine (IG). Assuming no difference in HbA1c change from baseline at Week 26 between LY2189265 and IG, this sample size would provide approximately 90% power to confirm non-inferiority of LY2189265 to IG. This computation was based on a non-inferiority margin of 0.4% with a standard deviation of 1.1%, a 1-sided alpha level of 0.025, and an 11% dropout rate between randomization and Week 26.||-0.41|-0.67|<0.001
71136650|NCT01584232|141775502|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison for HbA1c \<=6.5%.|Regression, Logistic|||||||<0.001
71136651|NCT01584232|141775502|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison for HbA1c \<7%.|Regression, Logistic|||||||<0.001
71136652|NCT01584232|141775503|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5||||0.183|TWO_SIDED|95.0|-1.7|8.7|||Mixed Models Analysis|||||8.7|-1.7|0.183
71136653|NCT01584232|141775504|SUPERIORITY_OR_OTHER||LS Mean Difference|5.16||||0.022|TWO_SIDED|95.0|0.76|9.56||Treatment comparison for pre-morning meal.|ANCOVA|||||9.56|0.76|0.022
71136654|NCT01584232|141775504|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.4||||0.003|TWO_SIDED|95.0|-22.28|-4.52||Treatment comparison for 2 hours post-morning meal.|ANCOVA|||||-4.52|-22.28|0.003
71136655|NCT01584232|141775504|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.22||||0.025|TWO_SIDED|95.0|-15.37|-1.06||Treatment comparison for pre-midday meal.|ANCOVA|||||-1.06|-15.37|0.025
71136656|NCT01584232|141775504|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.22|||<|0.001|TWO_SIDED|95.0|-31.92|-14.51||Treatment comparison for 2 hours post-midday meal.|ANCOVA|||||-14.51|-31.92|<0.001
71136657|NCT01584232|141775504|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.63|||<|0.001|TWO_SIDED|95.0|-21.03|-6.24||Treatment comparison for pre-evening meal.|ANCOVA|||||-6.24|-21.03|<0.001
71136658|NCT01584232|141775504|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.13|||<|0.001|TWO_SIDED|95.0|-39.26|-23.0||Treatment comparison for 2 hours post-evening meal.|ANCOVA|||||-23.00|-39.26|<0.001
71136659|NCT01584232|141775504|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.73|||<|0.001|TWO_SIDED|95.0|-31.68|-15.79||Treatment comparison for bedtime.|ANCOVA|||||-15.79|-31.68|<0.001
71136660|NCT01584232|141775504|SUPERIORITY_OR_OTHER||LS Mean Difference|6.21||||0.005|TWO_SIDED|95.0|1.92|10.5||Treatment comparison for second pre-morning meal.|ANCOVA|||||10.50|1.92|0.005
71136661|NCT01584232|141775505|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.42|||<|0.001|TWO_SIDED|95.0|-1.89|-0.94|||Mixed Models Analysis|||||-0.94|-1.89|<0.001
71136662|NCT01584232|141775506|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
71136663|NCT01507688|141775569|SUPERIORITY||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.17||0.05|TWO_SIDED|||||P-value was not adjusted for multiple comparisons. Models adjusted for: VA vs Non Va, admission diagnosis (transient ischemic attack vs stroke), sex (male vs female), white vs nonwhite, and baseline total Stroke Specific Quality of life score.|Mixed Models Analysis|Repeated measurements of change GEE analyses of Total Stroke Specific Quality of Life score change at 6 months from baseline.|The adjusted positive mean (standard error) change at 6 months from baseline was higher in the intervention arm compared to in the control arm. Intervention group had 0.14 (SE 0.17) higher improvement compared to the control group.|"All the sample size calculations were powered at 80% with a 5% Type I error. We estimated based on our pilot study a change difference of 0.25 on Total Stroke Specific Quality of Life in the intervention group compared to no change in the control group at 6 months. Our power calculations estimated a sample of 226 (113) per group was needed to detect this effect. We used primary outcome row Mean Change from 0 to 6 months for this analysis."||||0.0500
70863131|NCT01675427|141212905|SUPERIORITY_OR_OTHER|||||||0.2808|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2808
70863132|NCT01675427|141212905|SUPERIORITY_OR_OTHER|||||||0.2401|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.2401
70863133|NCT01675427|141212905|SUPERIORITY_OR_OTHER|||||||0.2993|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.2993
70863134|NCT01675427|141212905|SUPERIORITY_OR_OTHER|||||||0.5529|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.5529
70863135|NCT01675427|141212905|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0005
70863136|NCT01675427|141212906|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
70863137|NCT01675427|141212906|SUPERIORITY_OR_OTHER|||||||0.3572|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||0.3572
70863138|NCT01675427|141212906|SUPERIORITY_OR_OTHER|||||||0.2041|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.2041
70863139|NCT01675427|141212906|SUPERIORITY_OR_OTHER|||||||0.0467|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.0467
70863140|NCT01675427|141212906|SUPERIORITY_OR_OTHER|||||||0.0525|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.0525
70863141|NCT01675427|141212906|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
70863142|NCT01675427|141212907|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
70863143|NCT01675427|141212907|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||< 0.0001
70863144|NCT01675427|141212907|SUPERIORITY_OR_OTHER|||||||0.5275|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.5275
70863145|NCT01675427|141212907|SUPERIORITY_OR_OTHER|||||||0.6593|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.6593
70863146|NCT01675427|141212907|SUPERIORITY_OR_OTHER|||||||0.0372|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.0372
70863147|NCT01675427|141212907|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
70863148|NCT01675427|141212908|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
70863149|NCT01675427|141212908|SUPERIORITY_OR_OTHER|||||||0.3857|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||0.3857
70863150|NCT01675427|141212908|SUPERIORITY_OR_OTHER|||||||0.2356|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.2356
70863151|NCT01675427|141212908|SUPERIORITY_OR_OTHER|||||||0.7993|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.7993
70863152|NCT01675427|141212908|SUPERIORITY_OR_OTHER|||||||0.2164|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.2164
70863153|NCT01675427|141212908|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
70863154|NCT01675427|141212909|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
70863155|NCT01675427|141212909|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||0.0001
70863156|NCT01675427|141212909|SUPERIORITY_OR_OTHER|||||||0.482|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.4820
70863157|NCT01675427|141212909|SUPERIORITY_OR_OTHER|||||||0.8668|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.8668
71136664|NCT01507688|141775569|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.04||0.26|TWO_SIDED|||||Adjusted least square means (standard errors) adjusted for treatment (Intervention vs control), time of outcome from baseline (3, 6, 12 months), baseline SSQoL, Site (VA vs NonVA), Stroke/TIA diagnosis, sex (m vs f) and race (white vs nonwhite).|Mixed Models Analysis||Adjusted intervention arm's positive change (regression coefficient with standard error) in Total Stroke Specific Quality of Life was not significantly different at 12 months compared to the control group.|"We evaluated the mean difference on Total Stroke Specific Quality of Life compared to baseline between the intervention and control groups at 12 months using repeated measures ANCOVA models. We used primary outcome row Mean change from 0 to 12 months for this analysis."||||0.26
71136665|NCT02163824|141775570|SUPERIORITY||Difference in % of responders|16.1||||0.0024|TWO_SIDED|95.0|5.9|26.4|||Chi-squared||Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|"All statistical tests of hypotheses performed for the pairwise comparison of means were two-sided.~All statistical tests employed a level of significance of alpha = 0.05."||26.4|5.9|.0024
70863158|NCT01675427|141212909|SUPERIORITY_OR_OTHER|||||||0.2032|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.2032
70863159|NCT01675427|141212909|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
70863160|NCT01675427|141212910|SUPERIORITY_OR_OTHER|||||||0.0103|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||0.0103
70863161|NCT01675427|141212910|SUPERIORITY_OR_OTHER|||||||0.8373|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||0.8373
70863162|NCT01675427|141212910|SUPERIORITY_OR_OTHER|||||||0.3672|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.3672
71136666|NCT02163824|141775570|SUPERIORITY||Difference in % of responders|22.1|||<|0.0001|TWO_SIDED|95.0|11.7|32.6|||Chi-squared||Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|"All statistical tests of hypotheses performed for the pairwise comparison of means were two-sided.~All statistical tests employed a level of significance of alpha = 0.05."||32.6|11.7|<.0001
71136667|NCT02163824|141775571|SUPERIORITY||Difference in % of responders|19.5||||0.0019|TWO_SIDED|95.0|7.4|31.5|||Chi-squared||Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|"All statistical tests of hypotheses performed for the pairwise comparison of means were two-sided.~All statistical tests employed a level of significance of alpha = 0.05."||31.5|7.4|.0019
71136668|NCT02163824|141775571|SUPERIORITY||Difference in % of responders|22.5||||0.0003|TWO_SIDED|95.0|10.6|34.4|||Chi-squared||Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|"All statistical tests of hypotheses performed for the pairwise comparison of means were two-sided.~All statistical tests employed a level of significance of alpha = 0.05."||34.4|10.6|.0003
71136669|NCT02163824|141775572|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.0007|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference in mean AC grade at Day 8.|||||0.0007
71136670|NCT02163824|141775572|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.044|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference in mean grade AC at Day 8.|||||0.0440
71136671|NCT02163824|141775573|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.0391|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference in mean AC grade at Day 15.|||||0.0391
71136672|NCT02163824|141775573|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.1811|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference in mean AC grade at Day 15.|||||0.1811
71136673|NCT02163824|141775574|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.1953|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference in mean ocular pain grade at Day 8.|||||0.1953
71136674|NCT02163824|141775574|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.0307|TWO_SIDED||||||ANCOVA||Estimated value is the between group difference of mean ocular pain grade at Day 8.|||||0.0307
71136675|NCT02163824|141775575|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.2589|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference on mean ocular pain score at Day 15.|||||0.2589
71136676|NCT02163824|141775575|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.2132|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference in mean ocular pain score at Day 15.|||||0.2132
70863163|NCT01675427|141212911|SUPERIORITY_OR_OTHER|||||||0.0637|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.0637
70863164|NCT01675427|141212911|SUPERIORITY_OR_OTHER|||||||0.0474|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.0474
70863165|NCT01675427|141212911|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
70863166|NCT01675427|141212912|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
70863167|NCT01675427|141212912|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||< 0.0001
70863168|NCT01675427|141212912|SUPERIORITY_OR_OTHER|||||||0.5522|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.5522
71136677|NCT00790192|141775577|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
71136678|NCT00790192|141775578|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
71136679|NCT01544920|141775600|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower bound of the 95% CI of the difference in SVR24 % exceeded -10%.|Difference in SVR24% in Arm 2 vs. Arm 1|1.7|||||TWO_SIDED|95.0|-3.2|6.5||||||Difference in percentage of participants achieving SVR24||6.5|-3.2|
71136680|NCT01544920|141775601|NON_INFERIORITY_OR_EQUIVALENCE|The observed lower bound of the 95% CI for the difference was 2.5% (which exceeds 0) for BOC added to peg-IFN + RBV in contrast to peg-IFN + RBV alone.|Difference in SVR24%|10.3|||||TWO_SIDED|95.0|2.5|18.1||||||||18.1|2.5|
70948050|NCT00267098|141396965|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|3.623|||||TWO_SIDED|95.0|1.623|5.604||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead, a posterior distribution representing the set of possible values for the BiV - RV difference in improvement in LVEF through 24 months was used|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEF change through 24 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEF from randomization to 24 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEF from randomization to 24 months than patients with right ventricular pacing.||5.604|1.623|
70948051|NCT00267098|141396966|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-7.204|||||TWO_SIDED|95.0|-10.12|-4.214||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESVI through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESVI change through 6 months.|"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESVI from randomization to 6 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a different change in LVESVI from randomization to 6 months than patients with right ventricular pacing."||-4.214|-10.12|
70948052|NCT00267098|141396967|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-7.255|||||TWO_SIDED|95.0|-10.59|-3.829||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESVI through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESVI change through 12 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESVI from randomization to 12 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVESVI from randomization to 12 months than patients with right ventricular pacing.||-3.829|-10.590|
70948053|NCT00267098|141396968|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-8.242|||||TWO_SIDED|95.0|-11.86|-4.574||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESVI through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESVI change through 18 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESVI from randomization to 18 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVESVI from randomization to 18 months than patients with right ventricular pacing.||-4.574|-11.860|
70948054|NCT00267098|141396969|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-7.268|||||TWO_SIDED|95.0|-11.69|-2.846||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESVI through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESVI change through 24 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESVI from randomization to 24 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVESVI from randomization to 24 months than patients with right ventricular pacing.||-2.846|-11.690|
70948055|NCT00267098|141396970|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-5.858|||||TWO_SIDED|95.0|-9.085|-2.562||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDVI through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDVI change through 6 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDVI from randomization to 6 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEDVI from randomization to 6 months than patients with right ventricular pacing.||-2.562|-9.085|
70954414|NCT05126563|141411475|SUPERIORITY||LS Means|0.162|STANDARD_ERROR_OF_MEAN|0.725||0.824|TWO_SIDED|95.0|-1.29|1.61|||RMA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms Extreme Fatigue scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.61|-1.29|0.8240
70954415|NCT05126563|141411476|SUPERIORITY||LS Means|-0.009|STANDARD_ERROR_OF_MEAN|0.686||0.9892|TWO_SIDED|95.0|-1.38|1.36|||RMA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Brain Fog scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.36|-1.38|0.9892
71136681|NCT00466440|141775602|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.2||||1|TWO_SIDED|90.0|-12.52|12.95|||Chi-squared||The objective response rates and the 90% confidence intervals were estimated for the qualified participants using unadjusted normal approximation for binomial proportions (z approximation).|||12.95|-12.52|1.0000
71136682|NCT00466440|141775603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.6||||0.3606|TWO_SIDED|90.0|-28.21|4.95|||Chi-squared|||||4.95|-28.21|0.3606
70863169|NCT01675427|141212913|SUPERIORITY_OR_OTHER|||||||0.5117|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.5117
71136683|NCT00466440|141775604|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26||||0.072|TWO_SIDED|90.0|-0.02|0.55|||t-test, 1 sided|||||0.55|-0.02|0.0720
71136684|NCT00466440|141775605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15||||0.1697|TWO_SIDED|90.0|-0.07|0.37|||t-test, 1 sided|||||0.37|-0.07|0.1697
71136685|NCT00466440|141775606|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.524|TWO_SIDED|95.0|0.5|1.4|||Log Rank|||||1.4|0.5|0.5240
71136686|NCT00466440|141775607|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.4407|TWO_SIDED|95.0|0.3|1.6|||Log Rank|||||1.6|0.3|0.4407
71136687|NCT00466440|141775608|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.3449|TWO_SIDED|95.0|0.4|1.4|||Log Rank|||||1.4|0.4|0.3449
71136688|NCT00255190|141775647|SUPERIORITY_OR_OTHER|||||||0.042||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.042
71136689|NCT00255190|141775648|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.006
71136690|NCT00255190|141775649|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using a one-way analysis of covariance (ANCOVA) model with treatment as the factor and baseline score as the covariate.||||||0.204
71136691|NCT00255190|141775650|SUPERIORITY_OR_OTHER|||||||0.109||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.109
70863170|NCT01675427|141212913|SUPERIORITY_OR_OTHER|||||||0.3437|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.3437
71136692|NCT00255190|141775651|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||<0.001
71136693|NCT00255190|141775652|SUPERIORITY_OR_OTHER|||||||0.494||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.494
71136694|NCT00255190|141775653|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.026
71136695|NCT00255190|141775654|SUPERIORITY_OR_OTHER|||||||0.22||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.220
71136696|NCT00255190|141775655|SUPERIORITY_OR_OTHER|||||||0.843||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.843
71136697|NCT00255190|141775656|SUPERIORITY_OR_OTHER|||||||0.923||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.923
71136698|NCT00255190|141775657|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||<0.001
71136699|NCT00255190|141775658|SUPERIORITY_OR_OTHER|||||||0.758||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.758
71136700|NCT00255190|141775659|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.737
71136701|NCT00255190|141775660|SUPERIORITY_OR_OTHER|||||||0.673||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.673
71136702|NCT00255190|141775661|SUPERIORITY_OR_OTHER|||||||0.817||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.817
70954416|NCT05126563|141411477|SUPERIORITY||LS Means|0.439|STANDARD_ERROR_OF_MEAN|0.513||0.3952|TWO_SIDED|95.0|-0.59|1.47|||RMA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Headache scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.47|-0.59|0.3952
70863171|NCT01675427|141212913|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
70863172|NCT01675427|141212914|SUPERIORITY_OR_OTHER|||||||0.0381|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||0.0381
70863173|NCT01675427|141212914|SUPERIORITY_OR_OTHER|||||||0.6852|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||0.6852
70863174|NCT01675427|141212914|SUPERIORITY_OR_OTHER|||||||0.1185|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.1185
70863175|NCT01675427|141212915|SUPERIORITY_OR_OTHER|||||||0.2611|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.2611
70863176|NCT01675427|141212915|SUPERIORITY_OR_OTHER|||||||0.6059|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.6059
70863177|NCT01675427|141212915|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||0.0001
70863178|NCT01675427|141212916|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
70863179|NCT01675427|141212916|SUPERIORITY_OR_OTHER|||||||0.0048|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||0.0048
70863180|NCT01675427|141212916|SUPERIORITY_OR_OTHER|||||||0.5127|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.5127
70863181|NCT01675427|141212917|SUPERIORITY_OR_OTHER|||||||0.3465|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.3465
70863182|NCT01675427|141212917|SUPERIORITY_OR_OTHER|||||||0.7358|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.7358
70863183|NCT01675427|141212917|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
70863184|NCT01675427|141212918|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
70863185|NCT01675427|141212919|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
70863186|NCT01675427|141212920|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
70863187|NCT01675427|141212921|SUPERIORITY_OR_OTHER|||||||0.0066|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||0.0066
70863188|NCT01675427|141212922|SUPERIORITY_OR_OTHER|||||||0.0018|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||0.0018
70863189|NCT01675427|141212922|SUPERIORITY_OR_OTHER|||||||0.0425|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||0.0425
70863190|NCT01675427|141212922|SUPERIORITY_OR_OTHER|||||||0.9829|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.9829
70863191|NCT01675427|141212922|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.6700
70954417|NCT05126563|141411478|SUPERIORITY||LS Means|0.535|STANDARD_ERROR_OF_MEAN|0.704||0.4504|TWO_SIDED|95.0|-0.87|1.94|||RMA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Sleep Disturbances scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.94|-0.87|0.4504
70863192|NCT01675427|141212922|SUPERIORITY_OR_OTHER|||||||0.7672|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.7672
70863193|NCT01675427|141212922|SUPERIORITY_OR_OTHER|||||||0.0067|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||0.0067
70863194|NCT01675427|141212923|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||0.0003
70863195|NCT01675427|141212923|SUPERIORITY_OR_OTHER|||||||0.1637|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||0.1637
70863196|NCT01675427|141212923|SUPERIORITY_OR_OTHER|||||||0.8579|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.8579
70954418|NCT05126563|141411479|SUPERIORITY||LS Means|-0.161|STANDARD_ERROR_OF_MEAN|0.469||0.7318|TWO_SIDED|95.0|-1.1|0.78|||RMA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Loss of Taste scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.78|-1.10|0.7318
70863197|NCT01675427|141212923|SUPERIORITY_OR_OTHER|||||||0.6935|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.6935
70863198|NCT01675427|141212923|SUPERIORITY_OR_OTHER|||||||0.8124|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.8124
70863199|NCT01675427|141212923|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
70863200|NCT01675427|141212924|SUPERIORITY_OR_OTHER|||||||0.1834|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||0.1834
70863201|NCT01675427|141212924|SUPERIORITY_OR_OTHER|||||||0.8543|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||0.8543
70863202|NCT01675427|141212924|SUPERIORITY_OR_OTHER|||||||0.1485|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.1485
70863203|NCT01675427|141212924|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.0260
71136703|NCT00255190|141775662|SUPERIORITY_OR_OTHER|||||||0.601||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.601
70863204|NCT01675427|141212924|SUPERIORITY_OR_OTHER|||||||0.5317|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.5317
70863205|NCT01675427|141212924|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||0.0005
70863206|NCT01675427|141212925|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
70863207|NCT01675427|141212925|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||< 0.0001
70863208|NCT01675427|141212925|SUPERIORITY_OR_OTHER|||||||0.4423|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.4423
70863209|NCT01675427|141212925|SUPERIORITY_OR_OTHER|||||||0.3824|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.3824
70863210|NCT01675427|141212925|SUPERIORITY_OR_OTHER|||||||0.5246|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.5246
71136704|NCT00255190|141775663|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.065
70863211|NCT01675427|141212925|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
70863212|NCT01675427|141212926|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
70863213|NCT01675427|141212926|SUPERIORITY_OR_OTHER|||||||0.1947|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||0.1947
70863214|NCT01675427|141212926|SUPERIORITY_OR_OTHER|||||||0.0226|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.0226
70863215|NCT01675427|141212927|SUPERIORITY_OR_OTHER|||||||0.1158|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.1158
70863216|NCT01675427|141212927|SUPERIORITY_OR_OTHER|||||||0.3675|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.3675
70863217|NCT01675427|141212927|SUPERIORITY_OR_OTHER|||||||0.0948|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||0.0948
70863218|NCT01675427|141212928|SUPERIORITY_OR_OTHER|||||||0.1236|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||0.1236
70863219|NCT01675427|141212928|SUPERIORITY_OR_OTHER|||||||0.0119|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||0.0119
70863220|NCT01675427|141212928|SUPERIORITY_OR_OTHER|||||||0.7472|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.7472
70863221|NCT01675427|141212929|SUPERIORITY_OR_OTHER|||||||0.9734|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.9734
71136705|NCT00255190|141775664|SUPERIORITY_OR_OTHER|||||||0.319||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.319
70863222|NCT01675427|141212929|SUPERIORITY_OR_OTHER|||||||0.8303|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.8303
70863223|NCT01675427|141212929|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||0.0006
70863224|NCT01675427|141212930|SUPERIORITY_OR_OTHER|||||||0.0065|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||0.0065
70863225|NCT01675427|141212930|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||0.9999
70863226|NCT01675427|141212930|SUPERIORITY_OR_OTHER|||||||0.3472|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.3472
70863227|NCT01675427|141212931|SUPERIORITY_OR_OTHER|||||||0.2564|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.2564
70863228|NCT01675427|141212931|SUPERIORITY_OR_OTHER|||||||0.7361|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.7361
70863229|NCT01675427|141212931|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
70863230|NCT01675427|141212932|SUPERIORITY_OR_OTHER|||||||0.0097|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||0.0097
70863231|NCT01675427|141212932|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||< 0.0001
70863232|NCT01675427|141212932|SUPERIORITY_OR_OTHER|||||||0.9778|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.9778
70863233|NCT01675427|141212933|SUPERIORITY_OR_OTHER|||||||0.0151|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.0151
70863234|NCT01675427|141212933|SUPERIORITY_OR_OTHER|||||||0.1052|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.1052
70863235|NCT01675427|141212933|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||0.0007
70863236|NCT01675427|141212934|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
71136706|NCT00255190|141775665|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.011
70863237|NCT01675427|141212934|SUPERIORITY_OR_OTHER|||||||0.0012|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0012
70863238|NCT01675427|141212934|SUPERIORITY_OR_OTHER|||||||0.1717|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.1717
70863239|NCT01675427|141212934|SUPERIORITY_OR_OTHER|||||||0.0253|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.0253
70863240|NCT01675427|141212935|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
70863241|NCT01675427|141212935|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0330
70863242|NCT01675427|141212935|SUPERIORITY_OR_OTHER|||||||0.1595|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.1595
70863243|NCT01675427|141212935|SUPERIORITY_OR_OTHER|||||||0.0412|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.0412
70863244|NCT01675427|141212936|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1||||< 0.0001
70863245|NCT01675427|141212936|SUPERIORITY_OR_OTHER|||||||0.0421|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2||||0.0421
70863246|NCT01675427|141212936|SUPERIORITY_OR_OTHER|||||||0.7658|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3||||0.7658
70948056|NCT00267098|141396971|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-5.807|||||TWO_SIDED|95.0|-9.467|-2.038||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDVI through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDVI change through 12 months.|"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDVI from randomization to 12 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEDVI from randomization to 12 months than patients with right ventricular pacing."||-2.038|-9.467|
71136707|NCT00255190|141775666|SUPERIORITY_OR_OTHER|||||||0.207||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.207
70863247|NCT01675427|141212936|SUPERIORITY_OR_OTHER|||||||0.295|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4||||0.2950
70863248|NCT01675427|141212937|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1||||< 0.0001
70863249|NCT01675427|141212937|SUPERIORITY_OR_OTHER|||||||0.0827|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2||||0.0827
70863250|NCT01675427|141212937|SUPERIORITY_OR_OTHER|||||||0.7817|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3||||0.7817
70863251|NCT01675427|141212937|SUPERIORITY_OR_OTHER|||||||0.1986|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4||||0.1986
70863252|NCT01675427|141212938|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
70863253|NCT01675427|141212938|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0002
70863254|NCT01675427|141212938|SUPERIORITY_OR_OTHER|||||||0.0394|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0394
70863255|NCT01675427|141212938|SUPERIORITY_OR_OTHER|||||||0.0493|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.0493
70863256|NCT01675427|141212939|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
70863257|NCT01675427|141212939|SUPERIORITY_OR_OTHER|||||||0.0196|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0196
70863258|NCT01675427|141212939|SUPERIORITY_OR_OTHER|||||||0.3268|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.3268
70863259|NCT01675427|141212939|SUPERIORITY_OR_OTHER|||||||0.1667|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.1667
70863260|NCT01675427|141212940|SUPERIORITY_OR_OTHER|||||||0.0021|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G1||||0.0021
70863261|NCT01675427|141212940|SUPERIORITY_OR_OTHER|||||||0.5319|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G2||||0.5319
70863262|NCT01675427|141212940|SUPERIORITY_OR_OTHER|||||||0.0114|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G3||||0.0114
70948057|NCT00267098|141396972|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-8.844|||||TWO_SIDED|95.0|-12.91|-4.681||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDVI through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDVI change through 18 months.|"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDVI from randomization to 18 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEDVI from randomization to 18 months than patients with right ventricular pacing."||-4.681|-12.910|
70863263|NCT01675427|141212940|SUPERIORITY_OR_OTHER|||||||0.2293|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G4||||0.2293
70863264|NCT01675427|141212940|SUPERIORITY_OR_OTHER|||||||0.2857|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.2857
70863265|NCT01675427|141212940|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.0001
70863266|NCT01675427|141212941|SUPERIORITY_OR_OTHER|||||||0.0081|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G1||||0.0081
70863267|NCT01675427|141212941|SUPERIORITY_OR_OTHER|||||||0.0563|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G2||||0.0563
70863268|NCT01675427|141212941|SUPERIORITY_OR_OTHER|||||||0.3516|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G3||||0.3516
70863269|NCT01675427|141212941|SUPERIORITY_OR_OTHER|||||||0.0064|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G4||||0.0064
70863270|NCT01675427|141212941|SUPERIORITY_OR_OTHER|||||||0.2707|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.2707
70863271|NCT01675427|141212941|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||< 0.0001
70863272|NCT01675427|141212942|SUPERIORITY_OR_OTHER|||||||0.0634|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G1||||0.0634
70948058|NCT00267098|141396973|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-6.615|||||TWO_SIDED|95.0|-11.37|-1.736||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDVI through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDVI change through 24 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDVI from randomization to 24 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEDVI from randomization to 24 months than patients with right ventricular pacing.||-1.736|-11.370|
70954419|NCT05126563|141411480|SUPERIORITY||LS Means|-0.215|STANDARD_ERROR_OF_MEAN|0.357||0.5485|TWO_SIDED|95.0|-0.93|0.5|||RMA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Loss of Smell scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.50|-0.93|0.5485
70863273|NCT01675427|141212942|SUPERIORITY_OR_OTHER|||||||0.7176|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G2||||0.7176
70863274|NCT01675427|141212942|SUPERIORITY_OR_OTHER|||||||0.3944|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G3||||0.3944
70863275|NCT01675427|141212942|SUPERIORITY_OR_OTHER|||||||0.861|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G4||||0.8610
71136708|NCT00255190|141775667|SUPERIORITY_OR_OTHER|||||||0.286||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.286
71136709|NCT00255190|141775668|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.102
71136710|NCT00255190|141775669|SUPERIORITY_OR_OTHER|||||||0.656||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.656
71136711|NCT00255190|141775670|SUPERIORITY_OR_OTHER|||||||0.176||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.176
71136712|NCT00255190|141775671|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.030
71136713|NCT00255190|141775672|SUPERIORITY_OR_OTHER|||||||0.243||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.243
71136714|NCT00255190|141775673|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.005
71136715|NCT00255190|141775674|SUPERIORITY_OR_OTHER|||||||0.469||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.469
71136716|NCT03367858|141775687|SUPERIORITY|||||||0.0173||||||At 12 month follow up.|ANCOVA|||We conducted a repeated measures ANCOVA of Time (Post-Treatment: 3, 6, 12 months) × Treatment (MI, BAM) with the covariate of pre-treatment problem drinking.||||.0173
71136717|NCT01217463|141775690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.4109|TWO_SIDED|95.0|0.6|3.43|||Regression, Logistic|||||3.43|0.60|0.4109
71136718|NCT01217463|141775691|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37|||||TWO_SIDED|95.0|0.78|2.4|||Regression, Logistic|||||2.4|0.78|
71136719|NCT01623115|141775692|SUPERIORITY_OR_OTHER||LS mean difference|-57.9|||<|0.0001|TWO_SIDED|95.0|-63.3|-52.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-52.6|-63.3|<0.0001
71136720|NCT01623115|141775693|SUPERIORITY_OR_OTHER||LS mean difference|-58.1|||<|0.0001|TWO_SIDED|95.0|-63.5|-52.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-52.7|-63.5|<0.0001
71136721|NCT01623115|141775694|SUPERIORITY_OR_OTHER||LS mean difference|-49.2|||<|0.0001|TWO_SIDED|95.0|-53.9|-44.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-44.5|-53.9|<0.0001
70863276|NCT01675427|141212942|SUPERIORITY_OR_OTHER|||||||0.4543|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.4543
70863277|NCT01675427|141212942|SUPERIORITY_OR_OTHER|||||||0.0406|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.0406
70863278|NCT01675427|141212943|SUPERIORITY_OR_OTHER|||||||0.8234|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G1||||0.8234
70863279|NCT01675427|141212943|SUPERIORITY_OR_OTHER|||||||0.2427|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G2||||0.2427
70863280|NCT01675427|141212943|SUPERIORITY_OR_OTHER|||||||0.4805|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G3||||0.4805
70863281|NCT01675427|141212943|SUPERIORITY_OR_OTHER|||||||0.2901|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G4||||0.2901
70948059|NCT00267098|141396974|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-3.894|||||TWO_SIDED|95.0|-12.13|3.953||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LV Mass through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LV Mass change through 6 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in LV Mass through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in LV Mass through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value.||3.953|-12.130|
70948060|NCT00267098|141396975|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-10.16|||||TWO_SIDED|95.0|-19.33|-0.857||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LV Mass through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LV Mass change through 12 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in LV Mass through 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in LV Mass through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value.||-0.857|-19.330|
70948061|NCT00267098|141396976|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-8.316|||||TWO_SIDED|95.0|-18.19|1.623||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LV Mass through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LV Mass change through 18 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in LV Mass through 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in LV Mass through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value.||1.623|-18.190|
70948062|NCT00267098|141396977|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-11.08|||||TWO_SIDED|95.0|-21.11|-0.956||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LV Mass through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LV Mass change through 24 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in LV Mass through 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in LV Mass through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value.||-0.956|-21.110|
70863282|NCT01675427|141212943|SUPERIORITY_OR_OTHER|||||||0.3927|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.3927
70863283|NCT01675427|141212943|SUPERIORITY_OR_OTHER|||||||0.5769|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.5769
70863284|NCT00700570|141212946|SUPERIORITY_OR_OTHER|||||||0.1341|TWO_SIDED||||||Log Rank|||||||0.1341
70863285|NCT00700570|141212948|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Fisher Exact|||||||0.0010
70863286|NCT01461980|141212987|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.94|||||TWO_SIDED|95.0|0.86|1.03||||||Diphtheria: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Diphtheria antigens).||1.03|0.86|
70863287|NCT01461980|141212987|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.92|||||TWO_SIDED|95.0|0.85|0.99||||||Tetanus: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Tetanus antigens).||0.99|0.85|
70863288|NCT01461980|141212988|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.93|||||TWO_SIDED|95.0|0.85|1.02||||||Pertussis toxoid: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Pertussis toxoid).||1.02|0.85|
71136722|NCT01623115|141775695|SUPERIORITY_OR_OTHER||LS mean difference|-49.5|||<|0.0001|TWO_SIDED|95.0|-54.2|-44.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant)||-44.8|-54.2|<0.0001
71136723|NCT01623115|141775696|SUPERIORITY_OR_OTHER||LS mean difference|-45.8|||<|0.0001|TWO_SIDED|95.0|-49.8|-41.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-41.8|-49.8|<0.0001
71136724|NCT01623115|141775697|SUPERIORITY_OR_OTHER||LS mean difference|-45.9|||<|0.0001|TWO_SIDED|95.0|-49.9|-41.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-41.8|-49.9|<0.0001
71136725|NCT01623115|141775698|SUPERIORITY_OR_OTHER||LS mean difference|-52.4|||<|0.0001|TWO_SIDED|95.0|-57.2|-47.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-47.6|-57.2|<0.0001
71136726|NCT01623115|141775699|SUPERIORITY_OR_OTHER||LS mean difference|-52.6|||<|0.0001|TWO_SIDED|95.0|-57.5|-47.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-47.8|-57.5|<0.0001
71136727|NCT01623115|141775700|SUPERIORITY_OR_OTHER||LS mean difference|-38.7|||<|0.0001|TWO_SIDED|95.0|-42.4|-35.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-35|-42.4|<0.0001
71136728|NCT01623115|141775701|SUPERIORITY_OR_OTHER||LS mean difference|-37.5|||<|0.0001|TWO_SIDED|95.0|-41.2|-33.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-33.9|-41.2|<0.0001
71136729|NCT01623115|141775702|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.7|||<|0.0001|TWO_SIDED|95.0|-48.0|-39.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-39.4|-48|<0.0001
71136730|NCT01623115|141775703|SUPERIORITY_OR_OTHER||LS mean difference|-32.5|||<|0.0001|TWO_SIDED|95.0|-35.7|-29.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-29.2|-35.7|<0.0001
71136731|NCT01623115|141775704|SUPERIORITY_OR_OTHER||LS mean difference|-56.2|||<|0.0001|TWO_SIDED|95.0|-62.4|-50.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-50|-62.4|<0.0001
71136732|NCT01623115|141775705|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|156.0|||<|0.0001|TWO_SIDED|95.0|48.9|498.1||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||498.1|48.9|<0.0001
71136733|NCT01623115|141775706|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|156.6|||<|0.0001|TWO_SIDED|95.0|49.7|493.7||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||493.7|49.7|<0.0001
71136734|NCT01623115|141775707|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|244.9|||<|0.0001|TWO_SIDED|95.0|34.4|1744.4||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||1744.4|34.4|<0.0001
71136735|NCT01623115|141775708|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|240.0|||<|0.0001|TWO_SIDED|95.0|33.9|1700.7||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||1700.7|33.9|<0.0001
71136736|NCT01623115|141775709|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.7|||<|0.0001|TWO_SIDED|95.0|-22.6|-12.9||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-12.9|-22.6|<0.0001
71136737|NCT01623115|141775710|SUPERIORITY_OR_OTHER||LS mean difference|8.0|||<|0.0001|TWO_SIDED|95.0|5.0|11.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||11|5|<0.0001
71136738|NCT01623115|141775711|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-16.0|||<|0.0001|TWO_SIDED|95.0|-21.3|-10.6||Threshold for significance was ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-10.6|-21.3|<0.0001
71136739|NCT01623115|141775712|SUPERIORITY_OR_OTHER||LS mean difference|4.7|||=|0.0002|TWO_SIDED|95.0|2.3|7.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||7.2|2.3|= 0.0002
70863289|NCT01461980|141212988|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.91|||||TWO_SIDED|95.0|0.84|0.98||||||Pertussis filamentous hemagglutinin: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for pertussis filamentous hemagglutinin antigens).||0.98|0.84|
70863290|NCT01461980|141212988|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.88|||||TWO_SIDED|95.0|0.8|0.98||||||Pertussis pertactin: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for pertussis pertactin antigens).||0.98|0.80|
70863291|NCT01461980|141212988|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.9|||||TWO_SIDED|95.0|0.74|1.08||||||Pertussis fimbriae agglutinogens types 2 + 3: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for pertussis fimbriae agglutinogens types 2 + 3 antigens).||1.08|0.74|
70863292|NCT01461980|141212989|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67|GMT Ratio|0.91|||||TWO_SIDED|95.0|0.82|1.01||||||Serogroup A: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup A antigens).||1.01|0.82|
70863293|NCT01461980|141212989|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.9|1.15||||||Serogroup C: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup C antigens).||1.15|0.90|
70863294|NCT01461980|141212989|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.|GMT Ratio|0.99|||||TWO_SIDED|95.0|0.89|1.09||||||Serogroup Y: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup Y antigens).||1.09|0.89|
70863295|NCT01461980|141212989|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.|GMT Ratio|0.93|||||TWO_SIDED|95.0|0.83|1.04||||||Serogroup W-135: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup W-135 antigens).||1.04|0.83|
70863296|NCT01461980|141212990|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.|GMT Ratio|0.92|||||TWO_SIDED|95.0|0.84|1.02||||||PMB80 \[A22\]: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for hSBA strain titers).||1.02|0.84|
70863297|NCT01461980|141212990|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.82|1.0||||||PMB2948 \[B24\]: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for hSBA strain titers).||1.00|0.82|
70863298|NCT00809354|141213028|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.28|-0.57|||ANCOVA|||Analysis was based on analysis of co-variance (ANCOVA) model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.57|-1.28|<0.001
70863299|NCT00809354|141213028|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.06|-0.33|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.33|-1.06|<0.001
70863300|NCT00809354|141213028|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.18||0.001|TWO_SIDED|95.0|-0.94|-0.23|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.23|-0.94|0.001
70863301|NCT00809354|141213028|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.015|TWO_SIDED|95.0|-0.81|-0.09|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.09|-0.81|0.015
70863302|NCT00809354|141213028|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.18||0.453|TWO_SIDED|95.0|-0.49|0.22|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.49|0.453
71136740|NCT01623115|141775713|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.3|||<|0.0001|TWO_SIDED|95.0|-21.5|-13.0||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-13|-21.5|<0.0001
70863303|NCT00809354|141213028|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.18||0.177|TWO_SIDED|95.0|-0.61|0.11|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.61|0.177
70863304|NCT00809354|141213028|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.18||0.062|TWO_SIDED|95.0|-0.7|0.02|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.70|0.062
70863305|NCT00809354|141213028|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.18||0.212|TWO_SIDED|95.0|-0.59|0.13|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.59|0.212
70863306|NCT00809354|141213028|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.34|-0.54|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.54|-1.34|<0.001
70863307|NCT00809354|141213028|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.15|-0.35|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.35|-1.15|<0.001
70863308|NCT00809354|141213028|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.2||0.004|TWO_SIDED|95.0|-0.98|-0.18|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.18|-0.98|0.004
70863309|NCT00809354|141213028|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.2||0.007|TWO_SIDED|95.0|-0.95|-0.15|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.15|-0.95|0.007
70863310|NCT00809354|141213028|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.2||0.879|TWO_SIDED|95.0|-0.43|0.37|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.37|-0.43|0.879
70863311|NCT00809354|141213028|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.33|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.20|-0.60|0.330
70863312|NCT00809354|141213028|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.2||0.083|TWO_SIDED|95.0|-0.75|0.05|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.75|0.083
71136741|NCT01623115|141775714|SUPERIORITY_OR_OTHER||LS mean difference|4.3||||0.0031|TWO_SIDED|95.0|1.5|7.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||7.2|1.5|0.0031
70863313|NCT00809354|141213028|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.36|TWO_SIDED|95.0|-0.59|0.21|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.21|-0.59|0.360
70863314|NCT00809354|141213029|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.23|-0.53|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.53|-1.23|<0.001
70863315|NCT00809354|141213029|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.13|-0.43|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.43|-1.13|<0.001
70863316|NCT00809354|141213029|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.18||0.003|TWO_SIDED|95.0|-0.87|-0.17|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.17|-0.87|0.003
70863317|NCT00809354|141213029|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.18||0.007|TWO_SIDED|95.0|-0.83|-0.13|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.13|-0.83|0.007
70863318|NCT00809354|141213029|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.18||0.824|TWO_SIDED|95.0|-0.39|0.31|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.31|-0.39|0.824
70863319|NCT00809354|141213029|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.18||0.1|TWO_SIDED|95.0|-0.64|0.06|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.64|0.100
70863320|NCT00809354|141213029|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.18||0.044|TWO_SIDED|95.0|-0.7|-0.01|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.70|0.044
70863321|NCT00809354|141213029|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.565|TWO_SIDED|95.0|-0.45|0.25|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.25|-0.45|0.565
70863322|NCT00809354|141213029|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.4|-0.62|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.62|-1.40|<0.001
70863323|NCT00809354|141213029|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.2|-0.42|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.42|-1.20|<0.001
70863324|NCT00809354|141213029|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.2||0.002|TWO_SIDED|95.0|-1.02|-0.24|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.24|-1.02|0.002
70863325|NCT00809354|141213029|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.2||0.002|TWO_SIDED|95.0|-1.02|-0.24|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.24|-1.02|0.002
70863326|NCT00809354|141213029|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.2||0.98|TWO_SIDED|95.0|-0.39|0.4|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.40|-0.39|0.980
70863327|NCT00809354|141213029|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.2||0.383|TWO_SIDED|95.0|-0.56|0.22|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.56|0.383
70863328|NCT00809354|141213029|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.2||0.057|TWO_SIDED|95.0|-0.77|0.01|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.77|0.057
70948063|NCT00267098|141396978|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.126|||||TWO_SIDED|95.0|-0.235|-0.014||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDD through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDD change through 6 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDD from randomization to 6 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVEDD from randomization to 6 months than patients with RV pacing. Negative values reflect reductions in LVEDD.||-0.014|-0.235|
70954420|NCT05126563|141411511|SUPERIORITY||LS Means|-0.377|STANDARD_ERROR_OF_MEAN|0.407||0.3577|TWO_SIDED|95.0|-1.19|0.44|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Non-Neurological Symptoms. - Dyspnea at rest scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.44|-1.19|0.3577
70954421|NCT05126563|141411512|SUPERIORITY||LS Means|-0.203|STANDARD_ERROR_OF_MEAN|0.563||0.7196|TWO_SIDED|95.0|-1.33|0.92|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Non-Neurological Symptoms. - Dyspnea during activity scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.92|-1.33|0.7196
71136742|NCT01623115|141775715|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-9.7||||0.0003|TWO_SIDED|95.0|-15.0|-4.4||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-4.4|-15|0.0003
71136743|NCT01623115|141775716|SUPERIORITY_OR_OTHER||LS mean difference|2.8||||0.0187|TWO_SIDED|95.0|0.5|5.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.2|0.5|0.0187
71136744|NCT03827655|141775720|SUPERIORITY||Hazard Ratio (HR)|0.92|||=|0.649|TWO_SIDED|90.0|0.63|1.33||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% confidence intervals (CIs) and associated Wald Chi-square p-values between TAK-954 dose levels and placebo were obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.33|0.63|=0.649
71136745|NCT03827655|141775720|SUPERIORITY||Hazard Ratio (HR)|1.0|||=|0.505|TWO_SIDED|90.0|0.69|1.43||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.43|0.69|=0.505
71136746|NCT03827655|141775721|SUPERIORITY||Hazard Ratio (HR)|1.03|||=|0.449|TWO_SIDED|90.0|0.71|1.49||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.49|0.71|=0.449
71136747|NCT03827655|141775721|SUPERIORITY||Hazard Ratio (HR)|1.0|||=|0.507|TWO_SIDED|90.0|0.69|1.44||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.44|0.69|=0.507
71136748|NCT03827655|141775722|SUPERIORITY||Hazard Ratio (HR)|1.05|||=|0.406|TWO_SIDED|90.0|0.73|1.52||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.52|0.73|=0.406
71136749|NCT03827655|141775722|SUPERIORITY||Hazard Ratio (HR)|0.77|||=|0.88|TWO_SIDED|90.0|0.54|1.11||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.11|0.54|=0.880
71136750|NCT03827655|141775723|SUPERIORITY||Hazard Ratio (HR)|1.03|||=|0.446|TWO_SIDED|90.0|0.72|1.48||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.48|0.72|=0.446
71136751|NCT03827655|141775723|SUPERIORITY||Hazard Ratio (HR)|0.76|||=|0.892|TWO_SIDED|90.0|0.53|1.09||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.09|0.53|=0.892
71136752|NCT03827655|141775724|SUPERIORITY||Hazard Ratio (HR)|0.86|||=|0.76|TWO_SIDED|90.0|0.6|1.23||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.23|0.60|=0.760
70863329|NCT00809354|141213029|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.312|TWO_SIDED|95.0|-0.59|0.19|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.59|0.312
70863330|NCT00809354|141213030|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.07||0.008|TWO_SIDED|95.0|-0.32|-0.05|||ANCOVA|||Analysis was based on analysis of co-variance (ANCOVA) model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.05|-0.32|0.008
70863331|NCT00809354|141213030|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.251|TWO_SIDED|95.0|-0.22|0.06|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.22|0.251
70863332|NCT00809354|141213030|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.251|TWO_SIDED|95.0|-0.22|0.06|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.22|0.251
70863333|NCT00809354|141213030|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.961|TWO_SIDED|95.0|-0.14|0.13|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.14|0.961
70863334|NCT00809354|141213030|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.272|TWO_SIDED|95.0|-0.21|0.06|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.21|0.272
70863335|NCT00809354|141213030|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.271|TWO_SIDED|95.0|-0.21|0.06|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.21|0.271
70863336|NCT00809354|141213030|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.128|TWO_SIDED|95.0|-0.24|0.03|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.24|0.128
70863337|NCT00809354|141213030|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.133|TWO_SIDED|95.0|-0.24|0.03|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.24|0.133
70863338|NCT00809354|141213030|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED|95.0|-0.35|-0.08|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.08|-0.35|0.002
70863339|NCT00809354|141213030|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.004|TWO_SIDED|95.0|-0.34|-0.06|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.06|-0.34|0.004
70863340|NCT00809354|141213030|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.414|TWO_SIDED|95.0|-0.2|0.08|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.08|-0.20|0.414
70863341|NCT00809354|141213030|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.057|TWO_SIDED|95.0|-0.27|0.0|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.00|-0.27|0.057
70863342|NCT00809354|141213030|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.07||0.277|TWO_SIDED|95.0|-0.06|0.21|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.21|-0.06|0.277
70863343|NCT00809354|141213030|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.07||0.328|TWO_SIDED|95.0|-0.21|0.07|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.07|-0.21|0.328
70863344|NCT00809354|141213030|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.026|TWO_SIDED|95.0|-0.3|-0.02|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.02|-0.30|0.026
70863345|NCT00809354|141213030|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.864|TWO_SIDED|95.0|-0.15|0.13|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.15|0.864
70863346|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.16||0.927|TWO_SIDED|95.0|-0.31|0.34|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.34|-0.31|0.927
70863347|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.17||0.057|TWO_SIDED|95.0|-0.64|0.01|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.64|0.057
70863348|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.16||0.779|TWO_SIDED|95.0|-0.37|0.28|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.37|0.779
70863349|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.16||0.798|TWO_SIDED|95.0|-0.36|0.28|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.36|0.798
70863350|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.16||0.98|TWO_SIDED|95.0|-0.33|0.32|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.32|-0.33|0.980
70863351|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.16||0.098|TWO_SIDED|95.0|-0.6|0.05|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.60|0.098
70863352|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.709|TWO_SIDED|95.0|-0.26|0.38|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.38|-0.26|0.709
70863353|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.16||0.045|TWO_SIDED|95.0|0.01|0.65|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.65|0.01|0.045
71136753|NCT03827655|141775724|SUPERIORITY||Hazard Ratio (HR)|0.83|||=|0.81|TWO_SIDED|90.0|0.58|1.18||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-squared test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.18|0.58|=0.810
70863354|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.17||0.71|TWO_SIDED|95.0|-0.28|0.41|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.41|-0.28|0.710
70863355|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.17||0.504|TWO_SIDED|95.0|-0.46|0.23|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.46|0.504
70863356|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.17||0.183|TWO_SIDED|95.0|-0.11|0.58|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.58|-0.11|0.183
71136754|NCT03827655|141775725|SUPERIORITY||Hazard Ratio (HR)|1.13|||=|0.288|TWO_SIDED|90.0|0.78|1.64||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.64|0.78|=0.288
71136755|NCT03827655|141775725|SUPERIORITY||Hazard Ratio (HR)|1.03|||=|0.453|TWO_SIDED|90.0|0.72|1.47||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.47|0.72|=0.453
71136756|NCT03827655|141775726|SUPERIORITY||Risk Difference (RD)|-0.09|||=|0.046|TWO_SIDED|90.0|-0.17|0.0||P-value was derived using a one-sided test with Ha: Risk Difference\<0.|Stratified Miettinen and Nurminen||The p-values, risk differences and corresponding 90% CIs were obtained using a stratified Miettinen and Nurminen approach with strata weighting by sample size.|||0.00|-0.17|=0.046
71136757|NCT03827655|141775726|SUPERIORITY||Risk Difference (RD)|0.0|||=|0.516|TWO_SIDED|90.0|-0.11|0.11||P-value was derived using a one-sided test with Ha: Risk Difference\<0.|Stratified Miettinen and Nurminen||The p-values, risk differences and corresponding 90% CIs were obtained using a stratified Miettinen and Nurminen approach with strata weighting by sample size.|||0.11|-0.11|=0.516
71136758|NCT03827655|141775727|SUPERIORITY||Risk Difference (RD)|-0.03|||=|0.296|TWO_SIDED|90.0|-0.12|0.06||P-value was derived using a one-sided test with Ha: Risk Difference\<0.|Stratified Miettinen and Nurminen||The p-values, risk differences and corresponding 90% CIs were obtained using a stratified Miettinen and Nurminen approach with strata weighting by sample size.|||0.06|-0.12|=0.296
71136759|NCT03827655|141775727|SUPERIORITY||Risk Difference (RD)|0.03|||=|0.677|TWO_SIDED|90.0|-0.07|0.13||P-value was derived using a one-sided test with Ha: Risk Difference\<0.|Stratified Miettinen and Nurminen||The p-values, risk differences and corresponding 90% CIs were obtained using a stratified Miettinen and Nurminen approach with strata weighting by sample size.|||0.13|-0.07|=0.677
71136760|NCT03827655|141775728|SUPERIORITY||Hazard Ratio (HR)|1.1|||=|0.338|TWO_SIDED|90.0|0.76|1.57||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.57|0.76|=0.338
71136761|NCT03827655|141775728|SUPERIORITY||Hazard Ratio (HR)|1.04|||=|0.422|TWO_SIDED|90.0|0.73|1.49||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.49|0.73|=0.422
71136762|NCT01721161|141775734|SUPERIORITY_OR_OTHER||Difference|-3.48||||0.3337|TWO_SIDED|95.0|-10.61|3.65|||ANCOVA||Difference is calculated as BIIB033 100 mg/kg - placebo.|||3.65|-10.61|0.3337
71136763|NCT01721161|141775735|SUPERIORITY_OR_OTHER||Difference|-3.89||||0.1868|TWO_SIDED|95.0|-9.7|1.92|||ANCOVA||Difference is calculated as BIIB033 100 mg/kg - placebo.|||1.92|-9.70|0.1868
71136764|NCT01721161|141775736|SUPERIORITY_OR_OTHER||Difference|-4.76||||0.1488|TWO_SIDED|95.0|-11.26|1.74|||ANCOVA|||||1.74|-11.26|0.1488
71136765|NCT01721161|141775737|SUPERIORITY_OR_OTHER||Difference|-1.15||||0.4975|TWO_SIDED|95.0|-4.51|2.21|||ANCOVA||Difference is calculated as BIIB033 100 mg/kg - placebo.|||2.21|-4.51|0.4975
71136766|NCT01721161|141775738|SUPERIORITY_OR_OTHER||Difference|-1.76||||0.3505|TWO_SIDED|95.0|-5.5|1.98|||ANCOVA|||||1.98|-5.50|0.3505
71136767|NCT01721161|141775739|SUPERIORITY_OR_OTHER||Difference|-1.6||||0.5371|TWO_SIDED|95.0|-6.9|3.6|||ANCOVA||Difference is calculated as BIIB033 100 mg/kg - placebo.|LCLA 1.25% chart||3.6|-6.9|0.5371
71136768|NCT01721161|141775739|SUPERIORITY_OR_OTHER||Difference|-0.8||||0.7741|TWO_SIDED|95.0|-6.5|4.9|||ANCOVA||Difference is calculated as BIIB033 100 mg/kg - placebo.|LCLA 2.5% chart||4.9|-6.5|0.7741
71136769|NCT01721161|141775740|SUPERIORITY_OR_OTHER||Difference|-1.2||||0.6645|TWO_SIDED|95.0|-6.6|4.3|||ANCOVA|||LCLA 1.25% chart||4.3|-6.6|0.6645
71136770|NCT01721161|141775740|SUPERIORITY_OR_OTHER||DIfference|-0.8||||0.8015|TWO_SIDED|95.0|-6.7|5.2|||ANCOVA|||LCLA 2.5%||5.2|-6.7|0.8015
70954422|NCT05126563|141411513|SUPERIORITY||LS Means|-0.306|STANDARD_ERROR_OF_MEAN|0.435||0.4847|TWO_SIDED|95.0|-1.18|0.56|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Non-Neurological Symptoms. - Cough scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.56|-1.18|0.4847
71136771|NCT01721161|141775741|SUPERIORITY_OR_OTHER||Difference|-7.55||||0.0504|TWO_SIDED|95.0|-15.12|0.01|||ANCOVA|||||0.01|-15.12|0.0504
71136772|NCT02888106|141775750|SUPERIORITY|||||||0.0022|||||||Fisher Exact|||The proportions of negative HDV RNA response at week 72 in each of the MXB treatment groups were compared with the control group of PEG-IFNα by using Fisher's exact test and by presenting exact unconditional 95%-confidence intervals (CI) based on scores for the proportion differences.||||0.0022
71136773|NCT02888106|141775750|SUPERIORITY|||||||0.0996|||||||Fisher Exact|||||||0.0996
71136774|NCT02888106|141775750|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
71136775|NCT02888106|141775750|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
71136776|NCT02888106|141775750|SUPERIORITY|||||||0.0421|||||||Fisher Exact|||||||0.0421
71136777|NCT02888106|141775751|SUPERIORITY|||||||0.0052|||||||Fisher Exact|||Week 24||||0.0052
71136778|NCT02888106|141775751|SUPERIORITY|||||||0.0052|||||||Fisher Exact|||Week 24||||0.0052
71136779|NCT02888106|141775751|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
71136780|NCT02888106|141775751|SUPERIORITY|||||||0.0017|||||||Fisher Exact|||Week 24||||0.0017
71136781|NCT02888106|141775751|SUPERIORITY|||||||0.3295|||||||Fisher Exact|||Week 24||||0.3295
71136782|NCT02888106|141775751|SUPERIORITY|||||||0.0007|||||||Fisher Exact|||Week 48||||0.0007
71136783|NCT02888106|141775751|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||Week 48||||0.0001
71136784|NCT02888106|141775751|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
71136785|NCT02888106|141775751|SUPERIORITY|||||||0.0007|||||||Fisher Exact|||Week 48||||0.0007
71136786|NCT02888106|141775751|SUPERIORITY|||||||0.1086|||||||Fisher Exact|||Week 48||||0.1086
71136787|NCT02888106|141775752|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
71136788|NCT02888106|141775752|SUPERIORITY|||||||0.2241|||||||Fisher Exact|||Week 24||||0.2241
71136789|NCT02888106|141775752|SUPERIORITY|||||||0.0002|||||||Fisher Exact|||Week 24||||0.0002
71136790|NCT02888106|141775752|SUPERIORITY|||||||0.2241|||||||Fisher Exact|||Week 24||||0.2241
71136791|NCT02888106|141775752|SUPERIORITY|||||||0.0007|||||||Fisher Exact|||Week 24||||0.0007
71136792|NCT02888106|141775752|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
71136793|NCT02888106|141775752|SUPERIORITY|||||||0.4497|||||||Fisher Exact|||Week 48||||0.4497
71136794|NCT02888106|141775752|SUPERIORITY|||||||0.0268|||||||Fisher Exact|||Week 48||||0.0268
71136795|NCT02888106|141775752|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
71136796|NCT02888106|141775752|SUPERIORITY|||||||0.6999|||||||Fisher Exact|||Week 48||||0.6999
71136797|NCT02888106|141775752|SUPERIORITY|||||||0.0743|||||||Fisher Exact|||Week 72||||0.0743
71136798|NCT02888106|141775752|SUPERIORITY|||||||0.3449|||||||t-test, 1 sided|||Week 72||||0.3449
71136799|NCT02888106|141775752|SUPERIORITY|||||||0.6036|||||||Fisher Exact|||Week 72||||0.6036
71136800|NCT02888106|141775752|SUPERIORITY|||||||0.3408|||||||Fisher Exact|||Week 72||||0.3408
71136801|NCT02888106|141775752|SUPERIORITY|||||||0.3408|||||||Fisher Exact|||Week 72||||0.3408
71136802|NCT02888106|141775753|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
71136803|NCT02888106|141775753|SUPERIORITY|||||||0.2241|||||||Fisher Exact|||Week 24||||0.2241
71136804|NCT02888106|141775753|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 24||||0.4828
71136805|NCT02888106|141775753|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 24||||0.4828
71136806|NCT02888106|141775753|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 24||||0.4828
71136807|NCT02888106|141775753|SUPERIORITY|||||||0.5977|||||||Fisher Exact|||Week 48||||0.5977
71136808|NCT02888106|141775753|SUPERIORITY|||||||0.1686|||||||Fisher Exact|||Week 48||||0.1686
71136809|NCT02888106|141775753|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
71136810|NCT02888106|141775753|SUPERIORITY|||||||0.5977|||||||Fisher Exact|||Week 48||||0.5977
71136811|NCT02888106|141775753|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
71136812|NCT02888106|141775753|SUPERIORITY|||||||0.0063|||||||Fisher Exact|||Week 72||||0.0063
71136813|NCT02888106|141775753|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 72||||0.4828
71136814|NCT02888106|141775753|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 72||||1.0000
71136815|NCT02888106|141775753|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 72||||1.0000
71136816|NCT02888106|141775753|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 72||||0.4828
71136817|NCT02888106|141775754|SUPERIORITY|||||||0.0801|||||||Fisher Exact|||Week 24||||0.0801
71136818|NCT02888106|141775754|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
71136819|NCT02888106|141775754|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
71136820|NCT02888106|141775754|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
71136821|NCT02888106|141775754|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
71136822|NCT02888106|141775754|SUPERIORITY|||||||0.0063|||||||Fisher Exact|||Week 48||||0.0063
71136823|NCT02888106|141775754|SUPERIORITY|||||||0.2241|||||||Fisher Exact|||Week 48||||0.2241
71136824|NCT02888106|141775754|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
71136825|NCT02888106|141775754|SUPERIORITY|||||||0.0169|||||||Regression, Cox|||Week 72||||0.0169
71136826|NCT02888106|141775754|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 72||||0.4828
71136827|NCT02888106|141775754|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 72||||0.4828
71136828|NCT02888106|141775755|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 48||||0.4828
71136829|NCT02888106|141775755|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
71136830|NCT02888106|141775755|SUPERIORITY|||||||0.2292|||||||Fisher Exact|||Week 72||||0.2292
71136831|NCT02888106|141775755|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 72||||1.0000
71136832|NCT02888106|141775756|SUPERIORITY|||||||0.4621|||||||Fisher Exact|||Week 24||||0.4621
71136833|NCT02888106|141775756|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||Week 24||||1.0000
70948064|NCT00267098|141396979|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.162|||||TWO_SIDED|95.0|-0.287|-0.035||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDD through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDD change through 12 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDD from randomization to 12 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVEDD from randomization to 12 months than patients with RV pacing. Negative values reflect reductions in LVEDD.||-0.035|-0.287|
71136834|NCT02888106|141775756|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
71136835|NCT02888106|141775756|SUPERIORITY|||||||0.4621|||||||Fisher Exact|||Week 24||||0.4621
71136836|NCT02888106|141775756|SUPERIORITY|||||||0.0253|||||||Fisher Exact|||Week 24||||0.0253
71136837|NCT02888106|141775756|SUPERIORITY|||||||0.0268|||||||Fisher Exact|||Week 48||||0.0268
71136838|NCT02888106|141775756|SUPERIORITY|||||||0.6999|||||||Fisher Exact|||Week 48||||0.6999
71136839|NCT02888106|141775756|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
71136840|NCT02888106|141775756|SUPERIORITY|||||||0.0656|||||||Fisher Exact|||Week 48||||0.0656
71136841|NCT02888106|141775756|SUPERIORITY|||||||0.0005|||||||Fisher Exact|||Week 48||||0.0005
70863357|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.17||0.919|TWO_SIDED|95.0|-0.36|0.33|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.33|-0.36|0.919
71136842|NCT02888106|141775756|SUPERIORITY|||||||0.1431|||||||Fisher Exact|||Week 72||||0.1431
71136843|NCT02888106|141775756|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 72||||1.0000
71136844|NCT02888106|141775756|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 72||||1.0000
71136845|NCT02888106|141775756|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 72||||1.0000
71136846|NCT02888106|141775756|SUPERIORITY|||||||0.7104|||||||Fisher Exact|||Week 72||||0.7104
71136847|NCT02673918|141775772|EQUIVALENCE|Differences (the number of participants in each of the three categories) between baseline and follow-up was calculated using a Wilcoxon signed-rank test. This was a feasibility test and no power calculation was performed.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71136848|NCT02673918|141775773|EQUIVALENCE|Differences (the number of participants in each of the three categories) between baseline and follow-up was calculated using a Wilcoxon signed-rank test. This was a feasibility test and no power calculation was performed.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71136849|NCT02927392|141775778|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
70954423|NCT05126563|141411514|SUPERIORITY||LS Means|0.619|STANDARD_ERROR_OF_MEAN|0.661||0.3535|TWO_SIDED|95.0|-0.71|1.94|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Non-Neurological Symptoms. - Body aches scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.94|-0.71|0.3535
70863358|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.17||0.152|TWO_SIDED|95.0|-0.09|0.59|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.59|-0.09|0.152
70863359|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.572|TWO_SIDED|95.0|-0.44|0.24|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.24|-0.44|0.572
70863360|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.17||0.337|TWO_SIDED|95.0|-0.51|0.18|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.18|-0.51|0.337
70863361|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.17||0.299|TWO_SIDED|95.0|-0.16|0.52|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.52|-0.16|0.299
71136850|NCT01708317|141775784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|||<|0.001||||||We used a cutoff of P\<0.05 as statistically significant.|Chi-squared|3 degrees of freedom to compare 4 time periods.||We compared testing in the 4 time frames described, including the time frame in which we enrolled patients in the ACASI.||||<.001
71136851|NCT03259555|141775791|SUPERIORITY||Treatment difference|0.14|||=|0.8797|TWO_SIDED|95.0|-1.74|2.03|||Mixed-effect Model Repeated Measure|"An unstructured covariance was used."|"Comparison between treatment groups was carried out using MMRM, with study center, treatment group, visit, and treatment group-by-visit interaction as factor and baseline-by-visit interaction as a covariate. An unstructured covariance was used."|||2.03|-1.74|=0.8797
71136852|NCT04970654|141775865|NON_INFERIORITY|Non-inferiority was considered confirmed if the lower bound of the 95% confidence interval was higher than the margin of -2.0 cm/year.|Treatment difference|0.6|||||TWO_SIDED|95.0|-0.2|1.3||||||Hypothetical strategy estimand. Height velocity at 52 weeks was analyzed using a mixed model for repeated measurements, with treatment, gender, age group, growth hormone (GH) peak group and gender by age group interaction term as factors and baseline height as a covariate, all nested within week as a factor.||1.3|-0.2|
71136853|NCT05579977|141775921|OTHER||LS Mean Difference|-0.95|||<|0.0001|TWO_SIDED|90.0|-1.2|-0.7|||Mixed Models Analysis|||||-0.70|-1.20|<.0001
71136854|NCT05579977|141775921|OTHER||LS Mean Difference|-1.3|||<|0.0001|TWO_SIDED|90.0|-1.55|-1.04|||Mixed Models Analysis|||||-1.04|-1.55|<.0001
71136855|NCT05579977|141775921|OTHER||LS Mean Difference|-1.37|||<|0.0001||90.0|-1.62|-1.11|||Mixed Models Analysis|||||-1.11|-1.62|<.0001
71136856|NCT05579977|141775921|OTHER||LS Mean Difference|-1.26|||<|0.0001|TWO_SIDED|90.0|-1.52|-1.01|||Mixed Models Analysis|||||-1.01|-1.52|<.0001
71136857|NCT05579977|141775921|OTHER||LS Mean Difference|-1.29|||<|0.0001||90.0|-1.55|-1.03|||Mixed Models Analysis|||||-1.03|-1.55|<.0001
71136858|NCT05579977|141775921|OTHER||LS Mean Difference|-0.86|||<|0.0001|TWO_SIDED|90.0|-1.12|-0.61|||Mixed Models Analysis|||||-0.61|-1.12|<.0001
71136859|NCT05579977|141775922|OTHER||LS Mean Difference|-2.44||||0.0055|TWO_SIDED|90.0|-3.88|-1.0|||Mixed Models Analysis|||||-1.00|-3.88|0.0055
71136860|NCT05579977|141775922|OTHER||LS Mean Difference|-4.37|||<|0.0001|TWO_SIDED|90.0|-5.84|-2.89|||Mixed Models Analysis|||||-2.89|-5.84|<.0001
71136861|NCT05579977|141775922|OTHER||LS Mean Difference|-5.63|||<|0.0001|TWO_SIDED|90.0|-7.07|-4.18|||Mixed Models Analysis|||||-4.18|-7.07|<.0001
71136862|NCT05579977|141775922|OTHER||LS Mean Difference|-5.04|||<|0.0001|TWO_SIDED|90.0|-6.5|-3.58|||Mixed Models Analysis|||||-3.58|-6.50|<.0001
70863362|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.17|-0.5|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.50|-1.17|<0.001
71136863|NCT05579977|141775922|OTHER||LS Mean Difference|-5.42|||<|0.0001|TWO_SIDED|90.0|-6.91|-3.93|||Mixed Models Analysis|||||-3.93|-6.91|<.0001
71136864|NCT05579977|141775925|OTHER||LS Mean Difference|-0.86|||<|0.0001|TWO_SIDED|90.0|-1.12|-0.61|||Mixed Models Analysis|||||-0.61|-1.12|<.0001
71136865|NCT01420926|141775932|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Stratified 1-sided log-rank|||||||0.30
71136866|NCT00932321|141775938|NON_INFERIORITY_OR_EQUIVALENCE|Primary hypothesis tested was the independence (lack of association) of mean number of IB days in Cycles 2-6 across treatment groups.||||||0.311|||||||Cochran-Mantel-Haenszel|Stratified by investigational site.||||||0.311
71136867|NCT02775916|141775940|SUPERIORITY||Mean Difference (Net)|-0.69|STANDARD_DEVIATION|1.332|||TWO_SIDED|95.0|-3.343|1.937||||||||1.937|-3.343|
71136868|NCT02775916|141775941|SUPERIORITY||Mean Difference (Net)|0.51|STANDARD_ERROR_OF_MEAN|1.466|||TWO_SIDED|95.0|-2.52|3.55||||||||3.55|-2.52|
71136869|NCT02775916|141775942|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|3.119|||TWO_SIDED|95.0|-6.08|6.89||||||||6.89|-6.08|
71136870|NCT02775916|141775942|SUPERIORITY||Mean Difference (Net)|4.33|STANDARD_ERROR_OF_MEAN|4.615|||TWO_SIDED|95.0|-5.27|13.93||||||||13.93|-5.27|
71136871|NCT02775916|141775943|SUPERIORITY||Mean Difference (Net)|-6.55|STANDARD_ERROR_OF_MEAN|7.27|||TWO_SIDED|95.0|-21.76|8.66||||||||8.66|-21.76|
71136872|NCT02775916|141775944|SUPERIORITY||Mean Difference (Net)|-10.97|STANDARD_ERROR_OF_MEAN|9.626|||TWO_SIDED|95.0|-30.94|9.0||||||||9.00|-30.94|
71136873|NCT02775916|141775945|SUPERIORITY||Mean Difference (Net)|-7.69|STANDARD_ERROR_OF_MEAN|10.595|||TWO_SIDED|95.0|-29.75|14.37||||||||14.37|-29.75|
71136874|NCT00865345|141775961|SUPERIORITY_OR_OTHER||Intercept from ANCOVA model|70.0|STANDARD_ERROR_OF_MEAN|2.0|<|0.05|TWO_SIDED|95.0|60.0|100.0|||ANCOVA|null model ANOVA is used to calculate 95% CI around accuracy rate. Intercept was fit in the abscence of other predictors.||||100|60|<0.05
70863363|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.22|-0.55|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.55|-1.22|<0.001
70863364|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.01|-0.34|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.34|-1.01|<0.001
71136875|NCT02723773|141775973|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|79.77|||||TWO_SIDED|95.0|73.72|84.61|||Poisson regression method||VE=1 - the relative risk (RR). RR=the ratio of the incidence rates of LTFU+Control \>=50YOA Group over Historical Control \>=50YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between LTFU+Control \>=50 YOA Group and Historical Control \>=50 YOA Group.||84.61|73.72|
71136876|NCT02723773|141775974|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|86.67|||||TWO_SIDED|95.0|75.55|93.36|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control 50-59 YOA Group over Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between LTFU+Control 50-59 YOA Group and Historical Control 50-59 YOA Group.||93.36|75.55|
71136877|NCT02723773|141775974|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|87.14|||||TWO_SIDED|95.0|74.17|94.35|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control 60-69 YOA Group over Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between LTFU+Control 60-69 YOA Group and Historical Control 60-69 YOA Group.||94.35|74.17|
71136878|NCT02723773|141775974|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|77.11|||||TWO_SIDED|95.0|69.37|83.14|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control \>=60 YOA Group over Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between LTFU+Control \>=60 YOA Group and Historical Control \>=60 YOA Group.||83.14|69.37|
71136879|NCT02723773|141775974|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|73.18|||||TWO_SIDED|95.0|62.94|80.92|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control \>=70 YOA Group over Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between LTFU+Control \>=70 YOA Group and Historical Control \>=70 YOA Group.||80.92|62.94|
71136880|NCT02723773|141775975|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|87.73|||||TWO_SIDED|95.0|84.89|90.12|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control 50 YOA Group.||90.12|84.89|
71136881|NCT02723773|141775975|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|91.74|||||TWO_SIDED|95.0|86.25|95.37|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group.||95.37|86.25|
71136882|NCT02723773|141775975|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.57|||||TWO_SIDED|95.0|86.66|96.24|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group.||96.24|86.66|
71136883|NCT02723773|141775975|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|86.45|||||TWO_SIDED|95.0|82.98|89.33|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group.||89.33|82.98|
71136884|NCT02723773|141775975|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|84.33|||||TWO_SIDED|95.0|79.91|87.93|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group.||87.93|79.91|
71136885|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|97.68|||||TWO_SIDED|95.0|93.07|99.53|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 1.||99.53|93.07|
70863365|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.17||0.003|TWO_SIDED|95.0|-0.85|-0.18|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.18|-0.85|0.003
70863366|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.17||0.341|TWO_SIDED|95.0|-0.5|0.17|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.50|0.341
70863367|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.17||0.031|TWO_SIDED|95.0|-0.71|-0.03|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.03|-0.71|0.031
70863368|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.17||0.349|TWO_SIDED|95.0|-0.49|0.17|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.49|0.349
70863369|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.17||0.78|TWO_SIDED|95.0|-0.29|0.38|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.38|-0.29|0.780
70863370|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.31|-0.58|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.58|-1.31|<0.001
70863371|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.29|-0.56|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.56|-1.29|<0.001
70863372|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-0.99|-0.26|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.26|-0.99|<0.001
70863373|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.19||0.005|TWO_SIDED|95.0|-0.88|-0.15|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.15|-0.88|0.005
70863374|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.19||0.562|TWO_SIDED|95.0|-0.47|0.26|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.26|-0.47|0.562
70863375|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.19||0.028|TWO_SIDED|95.0|-0.77|-0.04|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.77|0.028
70863376|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.19||0.084|TWO_SIDED|95.0|-0.68|0.04|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.68|0.084
71136886|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|96.76|||||TWO_SIDED|95.0|80.57|99.92|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 1.||99.92|80.57|
71136887|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|79.32|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 1.||100.00|79.32|
71136888|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|97.97|||||TWO_SIDED|95.0|92.46|99.76|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 1.||99.76|92.46|
71136889|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|97.57|||||TWO_SIDED|95.0|90.96|99.71|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 1.||99.71|90.96|
70948065|NCT00267098|141396980|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.163|||||TWO_SIDED|95.0|-0.293|-0.03||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDD through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDD change through 18 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDD from randomization to 18 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVEDD from randomization to 18 months than patients with RV pacing. Negative values reflect reductions in LVEDD.||-0.030|-0.293|
70948066|NCT00267098|141396981|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.245|||||TWO_SIDED|95.0|-0.39|-0.097||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDD through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDD change through 24 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDD from randomization to 24 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVEDD from randomization to 24 months than patients with RV pacing. Negative values reflect reductions in LVEDD.||-0.097|-0.390|
71136890|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.69|||||TWO_SIDED|95.0|86.15|96.57|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 2.||96.57|86.15|
71136891|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.66|||||TWO_SIDED|95.0|70.78|99.15|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 2.||99.15|70.78|
70863377|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.19||0.91|TWO_SIDED|95.0|-0.38|0.34|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.34|-0.38|0.910
70863378|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.4|-0.69|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.69|-1.40|<0.001
70863379|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.27|-0.56|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.56|-1.27|<0.001
70863380|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.25|-0.55|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.55|-1.25|<0.001
71136892|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|95.49|||||TWO_SIDED|95.0|72.11|99.89|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 2.||99.89|72.11|
71136893|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.71|||||TWO_SIDED|95.0|85.13|96.93|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 2.||96.93|85.13|
71136894|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.01|||||TWO_SIDED|95.0|82.82|96.88|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 2.||96.88|82.82|
71136895|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.36|||||TWO_SIDED|95.0|84.98|96.59|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 3.||96.59|84.98|
71136896|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|89.2|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 3.||100.00|89.20|
71136897|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|89.39|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 3.||100.00|89.39|
71136898|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|89.84|||||TWO_SIDED|95.0|79.81|95.51|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 3.||95.51|79.81|
70863381|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.18||0.003|TWO_SIDED|95.0|-0.88|-0.17|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.17|-0.88|0.003
70863382|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.18||0.039|TWO_SIDED|95.0|-0.72|-0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.02|-0.72|0.039
70863383|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.18||0.032|TWO_SIDED|95.0|-0.74|-0.03|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.03|-0.74|0.032
71136899|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|84.74|||||TWO_SIDED|95.0|68.99|93.35|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 3.||93.35|68.99|
71136900|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|89.75|||||TWO_SIDED|95.0|80.31|95.24|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 4.||95.24|80.31|
71136901|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|93.88|||||TWO_SIDED|95.0|60.62|99.85|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 4.||99.85|60.62|
71136902|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|91.62|||||TWO_SIDED|95.0|66.1|99.04|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 4.||99.04|66.10|
71136903|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|88.96|||||TWO_SIDED|95.0|77.96|95.13|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 4.||95.13|77.96|
71136904|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|87.86|||||TWO_SIDED|95.0|73.3|95.33|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 4.||95.33|73.30|
71136905|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|83.87|||||TWO_SIDED|95.0|68.31|92.63|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 6.||92.63|68.31|
71136906|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|87.5|||||TWO_SIDED|95.0|46.83|98.61|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 6.||98.61|46.83|
71136907|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.31|||||TWO_SIDED|95.0|48.79|99.82|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 6.||99.82|48.79|
71136908|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|82.98|||||TWO_SIDED|95.0|63.64|93.05|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 6.||93.05|63.64|
70954424|NCT05126563|141411515|SUPERIORITY||LS Means|0.472|STANDARD_ERROR_OF_MEAN|0.655||0.4746|TWO_SIDED|95.0|-0.84|1.78|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Non-Neurological Symptoms. - Joint Pain scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.78|-0.84|0.4746
70863384|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.18||0.409|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.20|-0.50|0.409
71136909|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|80.0|||||TWO_SIDED|95.0|54.3|92.5|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 6.||92.50|54.30|
71136910|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|83.61|||||TWO_SIDED|95.0|67.76|92.51|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 7.||92.51|67.76|
71136911|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|93.33|||||TWO_SIDED|95.0|56.67|99.84|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 7.||99.84|56.67|
71136912|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|84.62|||||TWO_SIDED|95.0|32.04|98.31|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 7.||98.31|32.04|
71136913|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|80.43|||||TWO_SIDED|95.0|59.54|91.58|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 7.||91.58|59.54|
71136914|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|78.79|||||TWO_SIDED|95.0|51.24|92.08|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 7.||92.08|51.24|
71136915|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|82.76|||||TWO_SIDED|95.0|65.98|92.14|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 8.||92.14|65.98|
71136916|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|86.67|||||TWO_SIDED|95.0|42.67|98.52|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 8.||98.52|42.67|
71136917|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|84.62|||||TWO_SIDED|95.0|32.04|98.31|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 8.||98.31|32.04|
70863385|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.18||0.461|TWO_SIDED|95.0|-0.49|0.22|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.49|0.461
70954425|NCT05126563|141411516|SUPERIORITY||LS Means|-1.433|STANDARD_ERROR_OF_MEAN|2.141||0.5059|TWO_SIDED|95.0|-5.72|2.85|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Subject's energy - Fatigue Assessment form scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||2.85|-5.72|0.5059
70863386|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.21|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.59|-0.84|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.84|-1.59|<0.001
70863387|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.4|-0.65|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.65|-1.40|<0.001
70863388|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.17|-0.43|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.43|-1.17|<0.001
70863389|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.19||0.002|TWO_SIDED|95.0|-0.97|-0.22|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.22|-0.97|0.002
70863390|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.19||0.281|TWO_SIDED|95.0|-0.58|0.17|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.58|0.281
70863391|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.19||0.023|TWO_SIDED|95.0|-0.81|-0.06|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.06|-0.81|0.023
70863392|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.19||0.031|TWO_SIDED|95.0|-0.79|-0.04|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.79|0.031
70948067|NCT00267098|141396982|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.066|||||TWO_SIDED|95.0|-0.185|0.055||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESD through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESD change through 6 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESD from randomization to 6 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVESD from randomization to 6 months than patients with RV pacing. Negative values reflect reductions in LVESD.||0.055|-0.185|
71136918|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|81.4|||||TWO_SIDED|95.0|59.97|92.45|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 8.||92.45|59.97|
71136919|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|80.65|||||TWO_SIDED|95.0|52.91|93.4|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 8.||93.40|52.91|
70863393|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.19||0.331|TWO_SIDED|95.0|-0.56|0.19|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.56|0.331
70863394|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.11|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.47|-0.75|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.75|-1.47|<0.001
70863395|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.33|-0.6|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.60|-1.33|<0.001
71136920|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|73.68|||||TWO_SIDED|95.0|52.89|86.16|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 9.||86.16|52.89|
70863396|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.03|-0.31|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.31|-1.03|<0.001
70863397|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-0.98|-0.26|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.26|-0.98|<0.001
70863398|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.18||0.781|TWO_SIDED|95.0|-0.41|0.31|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.31|-0.41|0.781
70863399|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.18||0.057|TWO_SIDED|95.0|-0.71|0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.71|0.057
71136921|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|66.67|||||TWO_SIDED|95.0|3.52|90.52|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 9.||90.52|3.52|
71136922|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|72.73|||||TWO_SIDED|95.0|-3.24|95.11|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 9.||95.11|-3.24|
70863400|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.18||0.016|TWO_SIDED|95.0|-0.8|-0.08|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.08|-0.80|0.016
70863401|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.18||0.45|TWO_SIDED|95.0|-0.5|0.22|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.50|0.450
70863402|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.47|-0.69|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.69|-1.47|<0.001
70863403|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.2|-0.42|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.42|-1.20|<0.001
70863404|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.12|-0.34|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.34|-1.12|<0.001
70863405|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.2||0.001|TWO_SIDED|95.0|-1.04|-0.26|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.26|-1.04|0.001
70863406|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.2||0.699|TWO_SIDED|95.0|-0.47|0.31|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.31|-0.47|0.699
70863407|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.2||0.408|TWO_SIDED|95.0|-0.55|0.22|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.55|0.408
70863408|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.2||0.077|TWO_SIDED|95.0|-0.74|0.04|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.74|0.077
70863409|NCT00809354|141213031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.2||0.182|TWO_SIDED|95.0|-0.65|0.12|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.65|0.182
70863410|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.16||0.798|TWO_SIDED|95.0|-0.36|0.28|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.36|0.798
70863411|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.16||0.779|TWO_SIDED|95.0|-0.37|0.28|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.37|0.779
70863412|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.17||0.057|TWO_SIDED|95.0|-0.64|0.01|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.64|0.057
70863413|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.16||0.927|TWO_SIDED|95.0|-0.31|0.34|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.34|-0.31|0.927
70863414|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.16||0.98|TWO_SIDED|95.0|-0.33|0.32|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.32|-0.33|0.980
70863415|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.16||0.098|TWO_SIDED|95.0|-0.6|0.05|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.60|0.098
70863416|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.709|TWO_SIDED|95.0|-0.26|0.38|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.38|-0.26|0.709
70948068|NCT00267098|141396983|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.104|||||TWO_SIDED|95.0|-0.236|0.029||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESD through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESD change through 12 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESD from randomization to 12 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVESD from randomization to 12 months than patients with RV pacing. Negative values reflect reductions in LVESD.||0.029|-0.236|
70954426|NCT05126563|141411517|SUPERIORITY||LS Means|-6.095|STANDARD_ERROR_OF_MEAN|4.99||0.2269|TWO_SIDED|95.0|-16.08|3.89|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups.|The null hypothesis is that the difference in change from baseline to Weeks 26 in Short Form 36 Health Survey Questionnaire (General Health) between treatment groups (HB-adMSCs - Placebo) is equal to zero.||3.89|-16.08|0.2269
70863417|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.16||0.045|TWO_SIDED|95.0|0.01|0.65|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.65|0.01|0.045
70863418|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.17||0.919|TWO_SIDED|95.0|-0.36|0.33|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.33|-0.36|0.919
70948069|NCT00267098|141396984|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.06|||||TWO_SIDED|95.0|-0.204|0.087||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESD through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESD change through 18 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESD from randomization to 18 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVESD from randomization to 18 months than patients with RV pacing. Negative values reflect reductions in LVESD.||0.087|-0.204|
70863419|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.17||0.183|TWO_SIDED|95.0|-0.11|0.58|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.58|-0.11|0.183
70863420|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.17||0.504|TWO_SIDED|95.0|-0.46|0.23|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.46|0.504
70863421|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.17||0.71|TWO_SIDED|95.0|-0.28|0.41|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.41|-0.28|0.710
70863422|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.17||0.152|TWO_SIDED|95.0|-0.09|0.59|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.59|-0.09|0.152
70863423|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.572|TWO_SIDED|95.0|-0.44|0.24|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.24|-0.44|0.572
70863424|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.17||0.337|TWO_SIDED|95.0|-0.51|0.18|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.18|-0.51|0.337
70863425|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.17||0.299|TWO_SIDED|95.0|-0.16|0.52|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.52|-0.16|0.299
70863426|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.17||0.005|TWO_SIDED|95.0|-0.82|-0.14|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.14|-0.82|0.005
70948070|NCT00267098|141396985|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.18|||||TWO_SIDED|95.0|-0.339|-0.018||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESD through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESD change through 24 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESD from randomization to 24 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVESD from randomization to 24 months than patients with RV pacing. Negative values reflect reductions in LVESD.||-0.018|-0.339|
70863427|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.05|-0.38|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.38|-1.05|<0.001
70863428|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.25|-0.57|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.57|-1.25|<0.001
70863429|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.23|-0.56|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.56|-1.23|<0.001
70863430|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.17||0.177|TWO_SIDED|95.0|-0.57|0.1|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.10|-0.57|0.177
70863431|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.17||0.014|TWO_SIDED|95.0|-0.76|-0.09|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.09|-0.76|0.014
70863432|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.17||0.286|TWO_SIDED|95.0|-0.52|0.15|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.52|0.286
70863433|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.17||0.952|TWO_SIDED|95.0|-0.33|0.35|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.35|-0.33|0.952
70863434|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.19||0.002|TWO_SIDED|95.0|-0.95|-0.21|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.21|-0.95|0.002
70954427|NCT05126563|141411518|SUPERIORITY||LS Means|-0.122|STANDARD_ERROR_OF_MEAN|1.392||0.8735|TWO_SIDED|95.0|-2.91|2.66|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in PHQ-9 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||2.66|-2.91|0.8735
71136923|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|76.19|||||TWO_SIDED|95.0|51.78|89.35|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 9.||89.35|51.78|
71136924|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|75.86|||||TWO_SIDED|95.0|43.69|91.07|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 9.||91.07|43.69|
71136925|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|71.7|||||TWO_SIDED|95.0|49.03|85.18|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 10.||85.18|49.03|
70863435|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.19||0.003|TWO_SIDED|95.0|-0.94|-0.2|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.20|-0.94|0.003
70863436|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.26|-0.52|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.52|-1.26|<0.001
70863437|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.29|-0.55|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.55|-1.29|<0.001
70948071|NCT00267098|141396986|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.683|||||TWO_SIDED|95.0|-2.828|1.506||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in MR through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean MR change through 6 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Mitral Regurgitation (MR) through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Mitral Regurgitation through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value.||1.506|-2.828|
71136926|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|77.89|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 10.||100.00|77.89|
70863438|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.19||0.972|TWO_SIDED|95.0|-0.36|0.38|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.38|-0.36|0.972
71136927|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|90.0|||||TWO_SIDED|95.0|29.71|99.77|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 10.||99.77|29.71|
71136928|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|60.53|||||TWO_SIDED|95.0|26.55|79.83|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 10.||79.83|26.55|
71136929|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|48.15|||||TWO_SIDED|95.0|-2.41|74.87|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 10.||74.87|-2.41|
71136930|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|82.0|||||TWO_SIDED|95.0|63.03|92.22|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 11.||92.22|63.03|
70863439|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.19||0.096|TWO_SIDED|95.0|-0.69|0.06|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.69|0.096
70863440|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.19||0.069|TWO_SIDED|95.0|-0.72|0.03|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.72|0.069
70954428|NCT05126563|141411519|SUPERIORITY||LS Means|-3.424|STANDARD_ERROR_OF_MEAN|4.82||0.4802|TWO_SIDED|95.0|-13.07|6.22|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in PHQ-9 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||6.22|-13.07|0.4802
70863441|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.19||0.902|TWO_SIDED|95.0|-0.39|0.35|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.35|-0.39|0.902
71136931|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|86.67|||||TWO_SIDED|95.0|42.67|98.52|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 11.||98.52|42.67|
71136932|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|65.07|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 11.||100.00|65.07|
71136933|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|79.41|||||TWO_SIDED|95.0|52.82|92.3|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 11.||92.30|52.82|
71136934|NCT02723773|141775976|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|72.0|||||TWO_SIDED|95.0|33.41|89.77|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 11.||89.77|33.41|
71136935|NCT02723773|141775977|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|87.5|||||TWO_SIDED|95.0|64.75|96.79|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control \>=50 YOA Group over Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between LTFU+Control \>=50 YOA Group and Historical Control\>=50 YOA Group.||96.79|64.75|
71136936|NCT02723773|141775977|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|46.59|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control 50-59 YOA Group over Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between LTFU+Control 50-59 YOA Group and Historical Control 50-59 YOA Group.||100.00|46.59|
71136937|NCT02723773|141775977|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|50.0|||||TWO_SIDED|95.0|-860.45|99.15|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control 60-69 YOA Group over Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between LTFU+Control 60-69 YOA Group and Historical Control 60-69 YOA Group.||99.15|-860.45|
71136938|NCT02723773|141775977|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|84.0|||||TWO_SIDED|95.0|53.66|95.95|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control \>=60 YOA Group over Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of PHN between LTFU+Control \>=60 YOA Group and Historical Control \>=60 YOA Group.||95.95|53.66|
71136939|NCT02723773|141775977|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|86.96|||||TWO_SIDED|95.0|56.83|97.49|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control \>=70 YOA Group over Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of PHN between LTFU+Control \>=70 YOA Group and Historical Control \>=70 YOA Group.||97.49|56.83|
71136940|NCT02723773|141775978|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|89.69|||||TWO_SIDED|95.0|78.67|95.7|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group.||95.70|78.67|
70863442|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.18||0.002|TWO_SIDED|95.0|-0.93|-0.22|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.22|-0.93|0.002
71136941|NCT02723773|141775978|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|77.79|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group.||100.00|77.79|
71136942|NCT02723773|141775978|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|74.75|||||TWO_SIDED|95.0|-155.17|99.49|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group.||99.49|-155.17|
70863443|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.33|-0.61|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.61|-1.33|<0.001
70863444|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.38|-0.66|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.66|-1.38|<0.001
70863445|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.55|-0.84|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.84|-1.55|<0.001
70863446|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.028|TWO_SIDED|95.0|-0.75|-0.04|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.75|0.028
70863447|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.013|TWO_SIDED|95.0|-0.81|-0.09|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.09|-0.81|0.013
70863448|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.18||0.217|TWO_SIDED|95.0|-0.58|0.13|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.58|0.217
70863449|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.18||0.351|TWO_SIDED|95.0|-0.53|0.19|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.53|0.351
70863450|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.05|-0.28|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.28|-1.05|<0.001
70863451|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.22|-0.45|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.45|-1.22|<0.001
70863452|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.38|-0.62|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.62|-1.38|<0.001
70863453|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.57|-0.8|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.80|-1.57|<0.001
70863454|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.2||0.389|TWO_SIDED|95.0|-0.55|0.22|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.55|0.389
70863455|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.2||0.087|TWO_SIDED|95.0|-0.72|0.05|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.72|0.087
70863456|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.2||0.072|TWO_SIDED|95.0|-0.74|0.03|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.74|0.072
71136943|NCT02723773|141775978|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|87.24|||||TWO_SIDED|95.0|73.29|94.72|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group.||94.72|73.29|
71136944|NCT02723773|141775978|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|88.08|||||TWO_SIDED|95.0|73.87|95.41|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group.||95.41|73.87|
71136945|NCT02723773|141775979|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|91.67|||||TWO_SIDED|95.0|43.68|99.81|||Poisson regression method||VE=1-RR. RR=the ratio of the incidence rates of LTFU+Control \>=50 YOA Group over Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between LTFU+Control \>=50 YOA Group and Historical Control \>=50 YOA Group.||99.81|43.68|
71136946|NCT02723773|141775979|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|-247.21|100.0|||Poisson regression method||VE=1-RR. RR=the ratio of the incidence rates of LTFU+Control 60-69YOA Group over Historical Control 60-69YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between LTFU+Control 60-69 YOA Group and Historical Control 60-69 YOA Group.||100.00|-247.21|
71136947|NCT02723773|141775979|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|90.91|||||TWO_SIDED|95.0|37.45|99.79|||Poisson regression method||VE=1-RR. RR=the ratio of the incidence rates of LTFU+Control \>=60YOA Group over Historical Control \>=60YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of HZ related complications between LTFU+Control \>=60 YOA Group and Historical Control \>=60 YOA Group.||99.79|37.45|
71136948|NCT02723773|141775979|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|88.89|||||TWO_SIDED|95.0|19.81|99.75|||Poisson regression method||VE=1-RR. RR=the ratio of the incidence rates of LTFU+Control \>=70YOA Group over Historical Control \>=70YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between LTFU+Control \>=70 YOA Group and Historical Control \>=70 YOA Group.||99.75|19.81|
71136949|NCT02723773|141775980|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.83|||||TWO_SIDED|95.0|71.57|99.17|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group.||99.17|71.57|
71136950|NCT02723773|141775980|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|-1830.98|100.0|||Poisson regression method||VE=1-RR. RR=the ratio of the incidence rates of HZ/su 50-59YOA Group over Placebo/Historical Control 50-59YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group.||100.00|-1830.98|
70863457|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.34|TWO_SIDED|95.0|-0.57|0.2|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.20|-0.57|0.340
70863458|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.06|-0.33|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.33|-1.06|<0.001
70863459|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.11|-0.39|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.39|-1.11|<0.001
70863460|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.42|-0.69|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.69|-1.42|<0.001
70863461|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.59|-0.87|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.87|-1.59|<0.001
70863462|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.18||0.762|TWO_SIDED|95.0|-0.42|0.31|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.31|-0.42|0.762
70863463|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.19||0.056|TWO_SIDED|95.0|-0.72|0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.72|0.056
70863464|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.18||0.01|TWO_SIDED|95.0|-0.84|-0.12|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.12|-0.84|0.010
70863465|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.19||0.335|TWO_SIDED|95.0|-0.54|0.19|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.54|0.335
70863466|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.18|-0.38|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.38|-1.18|<0.001
71136951|NCT02723773|141775980|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|17.55|100.0|||Poisson regression method||VE=1-RR. RR=the ratio of the incidence rates of HZ/su 60-69YOA Group over Placebo/Historical Control 60-69YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group.||100.00|17.55|
70863467|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.24|-0.44|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.44|-1.24|<0.001
70863468|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.25|-0.46|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.46|-1.25|<0.001
70863469|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.52|-0.73|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.73|-1.52|<0.001
70863470|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.2||0.782|TWO_SIDED|95.0|-0.46|0.34|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.34|-0.46|0.782
70863471|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.2||0.719|TWO_SIDED|95.0|-0.47|0.33|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.33|-0.47|0.719
70863472|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.2||0.158|TWO_SIDED|95.0|-0.69|0.11|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.69|0.158
70863473|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.2||0.183|TWO_SIDED|95.0|-0.67|0.13|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.67|0.183
70863474|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.18||0.004|TWO_SIDED|95.0|-0.9|-0.18|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.18|-0.90|0.004
70863475|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.05|-0.33|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.33|-1.05|<0.001
70863476|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.84|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.2|0.48|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.48|-1.20|<0.001
70863477|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.12|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.48|-0.76|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.76|-1.48|<0.001
70863478|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.18||0.408|TWO_SIDED|95.0|-0.51|0.21|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.21|-0.51|0.408
70863479|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.18||0.097|TWO_SIDED|95.0|-0.67|0.06|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.67|0.097
71136952|NCT02723773|141775980|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.28|||||TWO_SIDED|95.0|69.17|99.11|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group.||99.11|69.17|
71136953|NCT02723773|141775980|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|90.45|||||TWO_SIDED|95.0|60.93|98.91|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group.||98.91|60.93|
71136954|NCT03629886|141776005|OTHER|The IR (n/T) of incident cervical infection with HPV-16 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100 Person-years|0.15|||||TWO_SIDED|95.0|0.09|0.23||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=1963). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.||0.23|0.09|
71136955|NCT03629886|141776005|OTHER|The IR (n/T) of incident cervical infection with HPV-16 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.88|||||TWO_SIDED|95.0|0.73|1.05||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=1917). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.||1.05|0.73|
71136956|NCT03629886|141776005|OTHER|The IR (n/T) of incident cervical infection with HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.09|||||TWO_SIDED|95.0|0.05|0.15||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-18 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2356). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.||0.15|0.05|
71136957|NCT03629886|141776005|OTHER|The IR (n/T) of incident cervical infection with HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.44|||||TWO_SIDED|95.0|0.35|0.56||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-18 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2357). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.||0.56|0.35|
71136958|NCT03629886|141776005|OTHER|The IR (n/T) of incident cervical infection with HPV-16 and/or HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100 Person-years|0.2|||||TWO_SIDED|95.0|0.14|0.27||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16/18 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2534). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.||0.27|0.14|
71136959|NCT03629886|141776005|OTHER|The IR (n/T) of incident cervical infection with HPV-16 and/or HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100 Person-years|1.02|||||TWO_SIDED|95.0|0.88|1.18||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16/18 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2547). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.||1.18|0.88|
71136960|NCT03629886|141776006|OTHER|The IR (n/T) of incident cervical infection with HPV-16 and/or HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.25|||||TWO_SIDED|95.0|0.19|0.33||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16/18 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2818). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.33|0.19|
70863480|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.18||0.018|TWO_SIDED|95.0|-0.79|-0.07|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.07|-0.79|0.018
71136961|NCT03629886|141776006|OTHER|The IR (n/T) of incident cervical infection with HPV-16 and/or HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|1.21|||||TWO_SIDED|95.0|1.06|1.37||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16/18 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2815). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||1.37|1.06|
71136962|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.17|||||TWO_SIDED|95.0|0.11|0.24||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-16 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2718). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.24|0.11|
71136963|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.85|||||TWO_SIDED|95.0|0.72|0.99||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-16 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2722). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.99|0.72|
71136964|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.1|||||TWO_SIDED|95.0|0.06|0.15||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-18 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2781). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.15|0.06|
71136965|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.47||||||95.0|0.38|0.58||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-18 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2781). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.58|0.38|
71136966|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.21|||||TWO_SIDED|95.0|0.15|0.28||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-31 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2786). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.28|0.15|
71136967|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.48|||||TWO_SIDED|95.0|0.39|0.59||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-31 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2782). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.59|0.39|
71136968|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.25|||||TWO_SIDED|95.0|0.18|0.33||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-33 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2779). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.33|0.18|
71136969|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.41|||||TWO_SIDED|95.0|0.33|0.51||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-33 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2784). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.51|0.33|
71136970|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.3|||||TWO_SIDED|95.0|0.23|0.39||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-35 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2806). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.39|0.23|
71136971|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.36|||||TWO_SIDED|95.0|0.28|0.46||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-35 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2803). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.46|0.28|
71136972|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.88||||||95.0|0.75|1.02||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-39 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2759). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||1.02|0.75|
70863481|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.18||0.132|TWO_SIDED|95.0|-0.64|0.08|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.08|-0.64|0.132
70863482|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.21||0.001|TWO_SIDED|95.0|-1.08|-0.26|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||-0.26|-1.08|0.001
71136973|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.79|||||TWO_SIDED|95.0|0.67|0.93||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-39 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2773). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.93|0.67|
71136974|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.11|||||TWO_SIDED|95.0|0.07|0.16||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-45 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2794). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.16|0.07|
71136975|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.21|||||TWO_SIDED|95.0|0.15|0.28||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-45 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2802). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.28|0.15|
71136976|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|1.02|||||TWO_SIDED|95.0|0.88|1.18||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-51 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2753). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||1.18|0.88|
71136977|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|1.18|||||TWO_SIDED|95.0|1.03|1.34||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-51 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2756). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||1.34|1.03|
71136978|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|1.67|||||TWO_SIDED|95.0|1.48|1.87||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-52 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2666). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||1.87|1.48|
71136979|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|1.8|||||TWO_SIDED|95.0|1.61|2.0||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-52 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2663). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||2.00|1.61|
70863483|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.21||0.002|TWO_SIDED|95.0|-1.07|-0.25|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||-0.25|-1.07|0.002
71136980|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.61|||||TWO_SIDED|95.0|0.5|0.73||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-56 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2783). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.73|0.50|
71136981|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.64|||||TWO_SIDED|95.0|0.53|0.76||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-56 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2779). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.76|0.53|
71136982|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.51|||||TWO_SIDED|95.0|0.42|0.62||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-58 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2772). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.62|0.42|
71136983|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.65||||||95.0|0.55|0.77||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-58 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2768). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.77|0.55|
71136984|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.31|||||TWO_SIDED|95.0|0.24|0.4||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-59 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2814). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.40|0.24|
71136985|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.36|||||TWO_SIDED|95.0|0.28|0.45||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-59 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2797). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.45|0.28|
71136986|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.62|||||TWO_SIDED|95.0|0.51|0.74||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-66 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2779). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.74|0.51|
71136987|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.64|||||TWO_SIDED|95.0|0.54|0.77||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-66 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2763). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.77|0.54|
70863484|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|-1.19|-0.37|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||-0.37|-1.19|<0.001
70863485|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|-1.37|-0.55|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||-0.55|-1.37|<0.001
70863486|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.21||0.959|TWO_SIDED|95.0|-0.4|0.42|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||0.42|-0.40|0.959
71136988|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.56||||||95.0|0.46|0.68||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-68 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2775). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.68|0.46|
71136989|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.59|||||TWO_SIDED|95.0|0.49|0.71||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-68 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2785). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.71|0.49|
71136990|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.5|||||TWO_SIDED|95.0|0.41|0.61||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-31/33/45 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2823). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.61|0.41|
71136991|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.97|||||TWO_SIDED|95.0|0.84|1.12||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-31/33/45 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2824). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||1.12|0.84|
71136992|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.75|||||TWO_SIDED|95.0|0.63|0.88||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-16/18/33/31/45 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2823). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.88|0.63|
71136993|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|2.11|||||TWO_SIDED|95.0|1.91|2.33||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-16/18/33/31/45 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2825). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||2.33|1.91|
70863487|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.618|TWO_SIDED|95.0|-0.51|0.31|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||0.31|-0.51|0.618
71136994|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|5.13|||||TWO_SIDED|95.0|4.79|5.49||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HRW-HPV incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2823). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||5.49|4.79|
71136995|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|5.72|||||TWO_SIDED|95.0|5.36|6.1||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HRW-HPV incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2825). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||6.10|5.36|
71136996|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|5.29|||||TWO_SIDED|95.0|4.94|5.65||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HR-HPV incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2823). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||5.65|4.94|
71136997|NCT03629886|141776007|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|6.29|||||TWO_SIDED|95.0|5.91|6.69||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HR-HPV incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2825). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||6.69|5.91|
71136998|NCT00346216|141776016|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non inferiority required a hazard ratio of 1.12 or lower, as well as an upper 95% confidence limit of 1.33 or lower in the ITT population and of 1.40 or lower in the MITT population.|Hazard Ratio (HR)|0.93||||0.0002|TWO_SIDED|95.0|0.76|1.13||Non inferiority P value, α=0.025|Regression, Cox|||ITT Population||1.13|0.76|0.0002
71136999|NCT00346216|141776016|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio estimate does not exceed 1.40|Hazard Ratio (HR)|0.9||||0.0001|TWO_SIDED|95.0|0.72|1.14||Non inferiority P value, α=0.025|Regression, Cox|||MITT Population||1.14|0.72|0.0001
71137000|NCT00346216|141776016|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio estimate does not exceed 1.33|Hazard Ratio (HR)|0.86|||<|0.0001|TWO_SIDED|95.0|0.7|1.04||Non inferiority P value, α=0.025|Regression, Cox|||ITT Population||1.04|0.70|<0.0001
71137001|NCT00346216|141776016|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio (HR) estimate does not exceed 1.40|Hazard Ratio (HR)|0.81|||<|0.0001|TWO_SIDED|95.0|0.64|1.02||Non-inferiority P-value, α=0.025|Regression, Cox|||MITT Population||1.02|0.64|<0.0001
71137002|NCT00346216|141776016|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio (HR) estimate does not exceed 1.33|Hazard Ratio (HR)|1.08||||0.0182|TWO_SIDED|95.0|0.89|1.31||Non-inferiority P-value, α=0.025|Regression, Cox|||ITT Population||1.31|0.89|0.0182
71137003|NCT00346216|141776016|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio (HR) estimate does not exceed 1.40|Hazard Ratio (HR)|1.12||||0.025|TWO_SIDED|95.0|0.89|1.4||Non-inferiority P-value, α=0.025|Regression, Cox|||MITT Population||1.40|0.89|0.0250
71137004|NCT00346216|141776017|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.6427|TWO_SIDED|95.0|0.83|1.12|||Regression, Cox|||ITT Population||1.12|0.83|0.6427
71137005|NCT00346216|141776017|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.0597|TWO_SIDED|95.0|0.75|1.01|||Regression, Cox|||ITT Population||1.01|0.75|0.0597
71137006|NCT00346216|141776017|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.11||||0.1481|TWO_SIDED|95.0|0.96|1.29|||Regression, Cox|||ITT Population||1.29|0.96|0.1481
71137007|NCT00346216|141776017|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.95||||0.5758|TWO_SIDED|95.0|0.8|1.13|||Regression, Cox|||MITT Population||1.13|0.80|0.5758
71137008|NCT00346216|141776017|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.0204|TWO_SIDED|95.0|0.69|0.97|||Regression, Cox|||MITT Population||0.97|0.69|0.0204
71137009|NCT00346216|141776017|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17||||0.0751|TWO_SIDED|95.0|0.98|1.38|||Regression, Cox|||MITT Population||1.38|0.98|0.0751
71137010|NCT00346216|141776018|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.8576|TWO_SIDED|95.0|0.67|1.4|||Regression, Cox|||ITT Population||1.40|0.67|0.8576
71137011|NCT00346216|141776018|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||0.1202|TWO_SIDED|95.0|0.53|1.08|||Regression, Cox|||ITT Population||1.08|0.53|0.1202
71137012|NCT00346216|141776018|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.27||||0.1734|TWO_SIDED|95.0|0.9|1.81|||Regression, Cox|||ITT Population||1.81|0.90|0.1734
71137013|NCT00346216|141776018|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51||||0.0041|TWO_SIDED|95.0|0.32|0.81|||Regression, Cox|||MITT Population||0.81|0.32|0.0041
71137014|NCT00346216|141776018|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.43||||0.0003|TWO_SIDED|95.0|0.27|0.68|||Regression, Cox|||MITT Population||0.68|0.27|0.0003
71137015|NCT00346216|141776018|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.16||||0.4243|TWO_SIDED|95.0|0.8|1.69|||Regression, Cox|||MITT Population||1.69|0.80|0.4243
71137016|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.77|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|1.01|2.53|||Mixed Models Analysis|||Change from baseline to Month 1 (ITT)||2.53|1.01|<0.0001
71137017|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|0.39||0.0373|TWO_SIDED|95.0|0.05|1.56|||Mixed Models Analysis|||Change from baseline to Month 1 (ITT)||1.56|0.05|0.0373
71137018|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|0.39||0.0129|TWO_SIDED|95.0|0.2|1.72|||Mixed Models Analysis|||Change from baseline to Month 1 (ITT)||1.72|0.20|0.0129
71137019|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.39||0.183|TWO_SIDED|95.0|-0.25|1.29|||Mixed Models Analysis|||Change from baseline to Month 2 (ITT)||1.29|-0.25|0.1830
71137020|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.39||0.7777|TWO_SIDED|95.0|-0.88|0.66|||Mixed Models Analysis|||Change from baseline to Month 2 (ITT)||0.66|-0.88|0.7777
71137021|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.39||0.1072|TWO_SIDED|95.0|-0.14|1.4|||Mixed Models Analysis|||Change from baseline to Month 2 (ITT)||1.40|-0.14|0.1072
71137022|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|0.4||0.8237|TWO_SIDED|95.0|-0.12|1.46|||Mixed Models Analysis|||Change from baseline to Month 4 (ITT)||1.46|-0.12|0.8237
71137023|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.4||0.8237|TWO_SIDED|95.0|-0.88|0.7|||Mixed Models Analysis|||Change from baseline to Month 4 (ITT)||0.70|-0.88|0.8237
71137024|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.4||0.0587|TWO_SIDED|95.0|-0.03|1.55|||Mixed Models Analysis|||Change from baseline to Month 4 (ITT)||1.55|-0.03|0.0587
71137025|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.41||0.3129|TWO_SIDED|95.0|-0.39|1.23|||Mixed Models Analysis|||Change from baseline to Month 8 (ITT)||1.23|-0.39|0.3129
71137026|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.41||0.6526|TWO_SIDED|95.0|-0.63|1.0|||Mixed Models Analysis|||Change from baseline to Month 8 (ITT)||1.00|-0.63|0.6526
71137027|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.42||0.5774|TWO_SIDED|95.0|-0.58|1.05|||Mixed Models Analysis|||Change from baseline to Month 8 (ITT)||1.05|-0.58|0.5774
71137028|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|0.42||0.0632|TWO_SIDED|95.0|-0.04|1.62|||Mixed Models Analysis|||Change from baseline to Month 12 (ITT)||1.62|-0.04|0.0632
71137029|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.43||0.454|TWO_SIDED|95.0|-0.52|1.15|||Mixed Models Analysis|||Change from baseline to Month 12 (ITT)||1.15|-0.52|0.4540
71137030|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.43||0.2705|TWO_SIDED|95.0|-0.37|1.3|||Mixed Models Analysis|||Change from baseline to Month 12 (ITT)||1.30|-0.37|0.2705
71137031|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.44||0.5225|TWO_SIDED|95.0|-0.58|1.14|||Mixed Models Analysis|||Change from baseline to Month 18 (ITT)||1.14|-0.58|0.5225
71137032|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.44||0.5996|TWO_SIDED|95.0|-1.1|0.63|||Mixed Models Analysis|||Change from baseline to Month 18 (ITT)||0.63|-1.10|0.5996
71137033|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.44||0.2461|TWO_SIDED|95.0|-0.35|1.38|||Mixed Models Analysis|||Change from baseline to Month 18 (ITT)||1.38|-0.35|0.2461
71137034|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.46||0.8127|TWO_SIDED|95.0|-0.79|1.0|||Mixed Models Analysis|||Change from baseline to Month 24 (ITT)||1.00|-0.79|0.8127
71137035|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.46||0.9641|TWO_SIDED|95.0|-0.92|0.87|||Mixed Models Analysis|||Change from baseline to Month 24 (ITT)||0.87|-0.92|0.9641
71137036|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.46||0.7784|TWO_SIDED|95.0|-0.77|1.03|||Mixed Models Analysis|||Change from baseline to Month 24 (ITT)||1.03|-0.77|0.7784
71137037|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.49||0.2105|TWO_SIDED|95.0|-0.34|1.56|||Mixed Models Analysis|||Change from baseline to Month 30 (ITT)||1.56|-0.34|0.2105
71137038|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.49||0.2909|TWO_SIDED|95.0|-0.44|1.46|||Mixed Models Analysis|||Change from baseline to Month 30 (ITT)||1.46|-0.44|0.2909
71137039|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.49||0.8459|TWO_SIDED|95.0|-0.86|1.05|||Mixed Models Analysis|||Change from baseline to Month 30 (ITT)||1.05|-0.86|0.8459
70863488|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.149|TWO_SIDED|95.0|-0.71|0.11|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||0.11|-0.71|0.149
71137040|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|0.51||0.1116|TWO_SIDED|95.0|-0.19|1.8|||Mixed Models Analysis|||Change from baseline to Month 36 (ITT)||1.80|-0.19|0.1116
71137041|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.51||0.9751|TWO_SIDED|95.0|-0.98|1.01|||Mixed Models Analysis|||Change from baseline to Month 36 (ITT)||1.01|-0.98|0.9751
71137042|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|0.51||0.1202|TWO_SIDED|95.0|-0.21|1.79|||Mixed Models Analysis|||Change from baseline to Month 36 (ITT)||1.79|-0.21|0.1202
71137043|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.52||0.3767|TWO_SIDED|95.0|-0.56|1.48|||Mixed Models Analysis|||Change from baseline to Month 42 (ITT)||1.48|-0.56|0.3767
71137044|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.52||0.1123|TWO_SIDED|95.0|-1.85|0.19|||Mixed Models Analysis|||Change from baseline to Month 42 (ITT)||0.19|-1.85|0.1123
71137045|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.29|STANDARD_ERROR_OF_MEAN|0.52||0.0137|TWO_SIDED|95.0|0.26|2.31|||Mixed Models Analysis|||Change from baseline to Month 42 (ITT)||2.31|0.26|0.0137
71137046|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.77|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|1.07|2.47|||Mixed Models Analysis|||Change from Baseline to Month 1 (MITT)||2.47|1.07|<0.0001
71137047|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.84|STANDARD_ERROR_OF_MEAN|0.36||0.0197|TWO_SIDED|95.0|0.13|1.54|||Mixed Models Analysis|||Change from Baseline to Month 1 (MITT)||1.54|0.13|0.0197
71137048|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.36||0.0094|TWO_SIDED|95.0|0.23|1.64|||Mixed Models Analysis|||Change from Baseline to Month 1 (MITT)||1.64|0.23|0.0094
71137049|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.37||0.1247|TWO_SIDED|95.0|-0.16|1.31|||Mixed Models Analysis|||Change from baseline to Month 2 (MITT)||1.31|-0.16|0.1247
71137050|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.37||0.8278|TWO_SIDED|95.0|-0.81|0.65|||Mixed Models Analysis|||Change from baseline to Month 2 (MITT)||0.65|-0.81|0.8278
71137051|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.37||0.0802|TWO_SIDED|95.0|-0.08|1.39|||Mixed Models Analysis|||Change from baseline to Month 2 (MITT)||1.39|-0.08|0.0802
71137052|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|0.39||0.0822|TWO_SIDED|95.0|-0.09|1.46|||Mixed Models Analysis|||Change from baseline to Month 4 (MITT)||1.46|-0.09|0.0822
71137053|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.39||0.8314|TWO_SIDED|95.0|-0.86|0.69|||Mixed Models Analysis|||Change from baseline to Month 4 (MITT)||0.69|-0.86|0.8314
71137054|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|0.39||0.0516|TWO_SIDED|95.0|-0.01|1.54|||Mixed Models Analysis|||Change from baseline to Month 4 (MITT)||1.54|-0.01|0.0516
71137055|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.42||0.3202|TWO_SIDED|95.0|-0.4|1.24|||Mixed Models Analysis|||Change from baseline to Month 8 (MITT)||1.24|-0.40|0.3202
71137056|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.42||0.5893|TWO_SIDED|95.0|-0.6|1.05|||Mixed Models Analysis|||Change from baseline to Month 8 (MITT)||1.05|-0.60|0.5893
71137057|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.42||0.651|TWO_SIDED|95.0|-0.63|1.01|||Mixed Models Analysis|||Change from baseline to Month 8 (MITT)||1.01|-0.63|0.6510
71137058|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.44||0.0796|TWO_SIDED|95.0|-0.09|1.62|||Mixed Models Analysis|||Change from baseline to Month 12 (MITT)||1.62|-0.09|0.0796
71137059|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.44||0.5061|TWO_SIDED|95.0|-0.57|1.15|||Mixed Models Analysis|||Change from baseline to Month 12 (MITT)||1.15|-0.57|0.5061
71137060|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.44||0.2796|TWO_SIDED|95.0|-0.38|1.33|||Mixed Models Analysis|||Change from baseline to Month 12 (MITT)||1.33|-0.38|0.2796
71137061|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.45||0.6725|TWO_SIDED|95.0|-0.69|1.08|||Mixed Models Analysis|||Change from baseline to Month 18 (MITT)||1.08|-0.69|0.6725
71137062|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.45||0.6381|TWO_SIDED|95.0|-1.1|0.67|||Mixed Models Analysis|||Change from baseline to Month 18 (MITT)||0.67|-1.10|0.6381
71137063|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.45||0.3737|TWO_SIDED|95.0|-0.49|1.29|||Mixed Models Analysis|||Change from baseline to Month 18 (MITT)||1.29|-0.49|0.3737
71137064|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.47||0.9139|TWO_SIDED|95.0|-0.87|0.97|||Mixed Models Analysis|||Change from baseline to Month 24 (MITT)||0.97|-0.87|0.9139
71137065|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.47||0.9998|TWO_SIDED|95.0|-0.92|0.92|||Mixed Models Analysis|||Change from baseline to Month 24 (MITT)||0.92|-0.92|0.9998
71137066|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.47||0.9144|TWO_SIDED|95.0|-0.88|0.98|||Mixed Models Analysis|||Change from baseline to Month 24 (MITT)||0.98|-0.88|0.9144
71137067|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|0.51||0.225|TWO_SIDED|95.0|-0.38|1.61|||Mixed Models Analysis|||Change from baseline to Month 30 (MITT)||1.61|-0.38|0.2250
71137068|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|0.51||0.2758|TWO_SIDED|95.0|-0.44|1.55|||Mixed Models Analysis|||Change from baseline to Month 30 (MITT)||1.55|-0.44|0.2758
71137069|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.51||0.903|TWO_SIDED|95.0|-0.94|1.06|||Mixed Models Analysis|||Change from baseline to Month 30 (MITT)||1.06|-0.94|0.9030
71137070|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.53||0.091|TWO_SIDED|95.0|-0.14|1.94|||Mixed Models Analysis|||Change from baseline to Month 36 (MITT)||1.94|-0.14|0.0910
71137071|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.53||0.7668|TWO_SIDED|95.0|-0.88|1.2|||Mixed Models Analysis|||Change from baseline to Month 36 (MITT)||1.20|-0.88|0.7668
71137072|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.74|STANDARD_ERROR_OF_MEAN|0.53||0.1653|TWO_SIDED|95.0|-0.31|1.78|||Mixed Models Analysis|||Change from baseline to Month 36 (MITT)||1.78|-0.31|0.1653
71137073|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.55||0.4323|TWO_SIDED|95.0|-0.65|1.52|||Mixed Models Analysis|||Change from baseline to Month 42 (MITT)||1.52|-0.65|0.4323
71137074|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.55||0.1439|TWO_SIDED|95.0|-1.89|0.28|||Mixed Models Analysis|||Change from baseline to Month 42 (MITT)||0.28|-1.89|0.1439
71137075|NCT00346216|141776019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.24|STANDARD_ERROR_OF_MEAN|0.55||0.0251|TWO_SIDED|95.0|0.16|2.33|||Mixed Models Analysis|||Change from baseline to Month 42 (MITT)||2.33|0.16|0.0251
71137076|NCT02341235|141776024|SUPERIORITY|||||||0.35|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.35
71137077|NCT02341235|141776025|SUPERIORITY|||||||0.22|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||0.22
71137078|NCT02341235|141776026|SUPERIORITY|||||||0.97|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.97
71137079|NCT02341235|141776027|SUPERIORITY|||||||0.98|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.98
71137080|NCT02341235|141776028|SUPERIORITY|||||||0.83|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.83
71137081|NCT02341235|141776029|SUPERIORITY|||||||0.055|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.055
71137082|NCT02341235|141776030|SUPERIORITY|||||||0.71|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.71
71137083|NCT02341235|141776031|SUPERIORITY|||||||0.33|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.33
71137084|NCT02341235|141776032|SUPERIORITY|||||||0.94|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.94
71137085|NCT02341235|141776033|SUPERIORITY|||||||0.57|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.57
71137086|NCT02341235|141776034|SUPERIORITY|||||||0.3|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.30
71137087|NCT02341235|141776035|SUPERIORITY|||||||0.44|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.44
71137088|NCT02341235|141776036|SUPERIORITY|||||||0.62|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.62
71137089|NCT02341235|141776037|SUPERIORITY|||||||0.7|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.70
71137090|NCT02341235|141776038|SUPERIORITY|||||||0.41|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.41
71137091|NCT02341235|141776039|SUPERIORITY|||||||0.72|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.72
71137092|NCT02341235|141776046|SUPERIORITY|||||||0.084|||||||ANCOVA|||||||0.084
71137093|NCT02341235|141776048|SUPERIORITY|||||||0.58|||||||ANCOVA|||||||0.580
71137094|NCT02341235|141776056|SUPERIORITY|||||||0.461|||||||ANCOVA|||||||0.461
71137095|NCT02341235|141776058|SUPERIORITY|||||||0.934|||||||ANCOVA|||||||0.934
71137096|NCT04862065|141776078|SUPERIORITY||Clinical Specificity (%)|99.96|||||TWO_SIDED|95.0|99.92|99.99|||Binomial Distribution|Specificity sample size is a minimum of 15,000 donors.||||99.99|99.92|
71137097|NCT04862065|141776079|OTHER|95% Confidence Interval provided|Point Estimate|100.0|||||TWO_SIDED|95.0|99.09|100.0|||Sensitivity|||||100.00|99.09|
71137098|NCT04862065|141776080|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|94.87|100.0|||Sensitivity|||Sensitivity||100.00|94.87|
71137099|NCT03170661|141776083|SUPERIORITY|||||||0.94|||||||GEEGLM|Effects of GEEGLM covariates: surgeon, p = 0.24; surgery length, p= 0.73 and body mass index, p= 0.22).||||||0.94
70863489|NCT00809354|141213032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.21||0.37|TWO_SIDED|95.0|-0.6|0.22|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||0.22|-0.60|0.370
71137100|NCT03001557|141776096|SUPERIORITY||Least square mean (LSM) difference|3.177||||0.1099|TWO_SIDED|95.0|-0.741|7.096||Based on a mixed model for repeated measure (MMRM) analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||7.096|-0.741|0.1099
71137101|NCT03001557|141776096|SUPERIORITY||LSM Difference|2.802||||0.1576|TWO_SIDED|95.0|-1.119|6.723||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||6.723|-1.119|0.1576
71137102|NCT03001557|141776096|SUPERIORITY||LSM Difference|-0.96||||0.616|TWO_SIDED|95.0|-4.777|2.857||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||2.857|-4.777|0.6160
71137103|NCT03001557|141776096|SUPERIORITY||LSM Difference|0.713||||0.7135|TWO_SIDED|95.0|-3.16|4.585||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||4.585|-3.160|0.7135
71137104|NCT03001557|141776100|SUPERIORITY||LSM Difference|-5.098||||0.1582|TWO_SIDED|95.0|-12.24|2.045||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||2.045|-12.240|0.1582
71137105|NCT03001557|141776100|SUPERIORITY||LSM Difference|-6.105||||0.0961|TWO_SIDED|95.0|-13.332|1.122||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1.122|-13.332|0.0961
71137106|NCT03001557|141776100|SUPERIORITY||LSM Difference|0.68||||0.8449|TWO_SIDED|95.0|-6.262|7.623||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||7.623|-6.262|0.8449
71137107|NCT03001557|141776100|SUPERIORITY||LSM Difference|-3.14||||0.3747|TWO_SIDED|95.0|-10.178|3.897||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||3.897|-10.178|0.3747
71137108|NCT03001557|141776104|SUPERIORITY||LSM Difference|1.932||||0.3966|TWO_SIDED|95.0|-2.601|6.465||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||6.465|-2.601|0.3966
71137109|NCT03001557|141776104|SUPERIORITY||LSM Difference|3.386||||0.1381|TWO_SIDED|95.0|-1.125|7.897||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||7.897|-1.125|0.1381
71137110|NCT03001557|141776104|SUPERIORITY||LSM Difference|1.337||||0.5487|TWO_SIDED|95.0|-3.104|5.778||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||5.778|-3.104|0.5487
71137111|NCT03001557|141776104|SUPERIORITY||LSM Difference|4.32||||0.0581|TWO_SIDED|95.0|-0.153|8.793||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||8.793|-0.153|0.0581
71137112|NCT03001557|141776108|SUPERIORITY||LSM Difference|-3.437||||0.1777|TWO_SIDED|95.0|-8.481|1.608||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1.608|-8.481|0.1777
71137113|NCT03001557|141776108|SUPERIORITY||LSM Difference|1.458||||0.563|TWO_SIDED|95.0|-3.564|6.479||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||6.479|-3.564|0.5630
71137114|NCT03001557|141776108|SUPERIORITY||LSM Difference|-4.994||||0.0482|TWO_SIDED|95.0|-9.946|-0.041||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||-0.041|-9.946|0.0482
70863490|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.16||0.887|TWO_SIDED|95.0|-0.33|0.28|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.33|0.887
71137115|NCT03001557|141776108|SUPERIORITY||LSM Difference|-2.593||||0.3036|TWO_SIDED|95.0|-7.599|2.413||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||2.413|-7.599|0.3036
71137116|NCT03001557|141776112|SUPERIORITY||LSM Difference|4.845||||0.1991|TWO_SIDED|95.0|-2.624|12.313||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||12.313|-2.624|0.1991
71137117|NCT03001557|141776112|SUPERIORITY||LSM Difference|-3.872||||0.2982|TWO_SIDED|95.0|-11.263|3.518||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||3.518|-11.263|0.2982
71137118|NCT03001557|141776112|SUPERIORITY||LSM Difference|6.776||||0.0664|TWO_SIDED|95.0|-0.474|14.025||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||14.025|-0.474|0.0664
71137119|NCT03001557|141776112|SUPERIORITY||LSM Difference|3.017||||0.4148|TWO_SIDED|95.0|-4.344|10.379||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||10.379|-4.344|0.4148
71137120|NCT03001557|141776116|SUPERIORITY||LSM Difference|0.063||||0.9599|TWO_SIDED|95.0|-2.452|2.579||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||2.579|-2.452|0.9599
71137121|NCT03001557|141776116|SUPERIORITY||LSM Difference|-0.238||||0.8541|TWO_SIDED|95.0|-2.817|2.342||Based on a MMRM analysis adjusted for baseline value, country, Visit and treatment by Visit interaction.|MMRM|||||2.342|-2.817|0.8541
71137122|NCT03001557|141776116|SUPERIORITY||LSM Difference|-0.293||||0.8117|TWO_SIDED|95.0|-2.745|2.16||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||2.160|-2.745|0.8117
71137123|NCT03001557|141776116|SUPERIORITY||LSM Difference|-1.557||||0.2274|TWO_SIDED|95.0|-4.113|1.0||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1.000|-4.113|0.2274
71137124|NCT03001557|141776120|SUPERIORITY||LSM Difference|0.086||||0.2421|TWO_SIDED|95.0|-0.06|0.232||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.232|-0.060|0.2421
71137125|NCT03001557|141776120|SUPERIORITY||LSM Difference|-0.012||||0.8661|TWO_SIDED|95.0|-0.155|0.131||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.131|-0.155|0.8661
71137126|NCT03001557|141776120|SUPERIORITY||LSM Difference|0.057||||0.4251|TWO_SIDED|95.0|-0.085|0.199||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.199|-0.085|0.4251
71137127|NCT03001557|141776120|SUPERIORITY||LSM Difference|0.025||||0.7248|TWO_SIDED|95.0|-0.116|0.166||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.166|-0.116|0.7248
71137128|NCT03001557|141776124|SUPERIORITY||LSM Difference|-0.032||||0.2991|TWO_SIDED|95.0|-0.094|0.029||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.029|-0.094|0.2991
71137129|NCT03001557|141776124|SUPERIORITY||LSM Difference|0.033||||0.2861|TWO_SIDED|95.0|-0.028|0.095||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.095|-0.028|0.2861
71137130|NCT03001557|141776124|SUPERIORITY||LSM Difference|-0.052||||0.0938|TWO_SIDED|95.0|-0.113|0.009||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.009|-0.113|0.0938
71137131|NCT03001557|141776124|SUPERIORITY||LSM Difference|0.005||||0.8618|TWO_SIDED|95.0|-0.055|0.066||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.066|-0.055|0.8618
71137132|NCT03001557|141776128|SUPERIORITY||LSM Difference|-389.873||||0.0294|TWO_SIDED|95.0|-739.177|-40.569||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||-40.569|-739.177|0.0294
71137133|NCT03001557|141776128|SUPERIORITY||LSM Difference|-402.994||||0.0243|TWO_SIDED|95.0|-751.67|-54.319||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||-54.319|-751.670|0.0243
71137134|NCT03001557|141776128|SUPERIORITY||LSM Difference|-141.026||||0.4209|TWO_SIDED|95.0|-489.805|207.752||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||207.752|-489.805|0.4209
71137135|NCT03001557|141776128|SUPERIORITY||LSM Difference|-367.845||||0.0398|TWO_SIDED|95.0|-717.87|-17.82||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||-17.820|-717.870|0.0398
71137136|NCT03001557|141776132|SUPERIORITY||LSM Difference|-1276.18||||0.1162|TWO_SIDED|95.0|-2878.587|326.226||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||326.226|-2878.587|0.1162
71137137|NCT03001557|141776132|SUPERIORITY||LSM Difference|227.464||||0.7781|TWO_SIDED|95.0|-1382.85|1837.777||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1837.777|-1382.850|0.7781
71137138|NCT03001557|141776132|SUPERIORITY||LSM Difference|-620.581||||0.4255|TWO_SIDED|95.0|-2170.342|929.179||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||929.179|-2170.342|0.4255
71137139|NCT03001557|141776132|SUPERIORITY||LSM Difference|-577.82||||0.4672|TWO_SIDED|95.0|-2160.337|1004.697||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1004.697|-2160.337|0.4672
71137140|NCT03001557|141776136|SUPERIORITY||LSM Difference|-839.088||||0.2984|TWO_SIDED|95.0|-2440.854|762.678||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||762.678|-2440.854|0.2984
71137141|NCT03001557|141776136|SUPERIORITY||LSM Difference|651.922||||0.4218|TWO_SIDED|95.0|-962.835|2266.678||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||2266.678|-962.835|0.4218
71137142|NCT03001557|141776136|SUPERIORITY||LSM Difference|-447.245||||0.5655|TWO_SIDED|95.0|-1998.44|1103.95||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1103.950|-1998.440|0.5655
71137143|NCT03001557|141776136|SUPERIORITY||LSM Difference|-130.603||||0.8686|TWO_SIDED|95.0|-1706.478|1445.272||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1445.272|-1706.478|0.8686
71137144|NCT03001557|141776140|SUPERIORITY||LSM Difference|0.02||||0.4638|TWO_SIDED|95.0|-0.034|0.074||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.074|-0.034|0.4638
71137145|NCT03001557|141776140|SUPERIORITY||LSM Difference|0.06||||0.0322|TWO_SIDED|95.0|0.005|0.115||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.115|0.005|0.0322
71137146|NCT03001557|141776140|SUPERIORITY||LSM Difference|0.003||||0.9144|TWO_SIDED|95.0|-0.051|0.056||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.056|-0.051|0.9144
71137147|NCT03001557|141776140|SUPERIORITY||LSM Difference|0.057||||0.0364|TWO_SIDED|95.0|0.004|0.11||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction|MMRM|||||0.110|0.004|0.0364
71137148|NCT01272232|141776146|SUPERIORITY_OR_OTHER||Treatment contrast|-3.97|||<|0.0001||95.0|-4.84|-3.11||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-3.11|-4.84|<0.0001
71137149|NCT01272232|141776146|SUPERIORITY_OR_OTHER||Treatment contrast|-2.62|||<|0.0001||95.0|-3.63|-1.62||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-1.62|-3.63|<0.0001
71137150|NCT01272232|141776146|SUPERIORITY_OR_OTHER||Treatment contrast|-1.35||||0.0024||95.0|-2.23|-0.48||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.48|-2.23|0.0024
71137151|NCT01272232|141776147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.81|||<|0.0001||95.0|4.34|10.68||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||10.68|4.34|<0.0001
70863491|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.16||0.046|TWO_SIDED|95.0|-0.62|-0.01|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.62|0.046
71137152|NCT01272232|141776147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.69|||<|0.0001||95.0|2.24|6.09||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||6.09|2.24|<0.0001
71137153|NCT01272232|141776147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.0008||95.0|1.29|2.64||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||2.64|1.29|0.0008
71137154|NCT01272232|141776148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.1|||<|0.0001||95.0|3.48|14.48||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||14.48|3.48|<0.0001
71137155|NCT01272232|141776148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.84||||0.0008||95.0|1.75|8.41||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||8.41|1.75|0.0008
71137156|NCT01272232|141776148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.0099||95.0|1.16|2.95||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||2.95|1.16|0.0099
71137157|NCT01272232|141776149|SUPERIORITY_OR_OTHER||Treatment contrast|-0.93|||<|0.0001||95.0|-1.08|-0.78||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.78|-1.08|<0.0001
71137158|NCT01272232|141776149|SUPERIORITY_OR_OTHER||Treatment contrast|-0.74|||<|0.0001||95.0|-0.91|-0.57||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.57|-0.91|<0.0001
71137159|NCT01272232|141776149|SUPERIORITY_OR_OTHER||Treatment contrast|-0.19||||0.0125||95.0|-0.34|-0.04||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.04|-0.34|0.0125
71137160|NCT01272232|141776150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.79|||<|0.0001||95.0|5.74|13.4||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||13.4|5.74|<0.0001
71137161|NCT01272232|141776150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.71|||<|0.0001||95.0|4.76|12.51||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||12.51|4.76|<0.0001
71137162|NCT01272232|141776150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.5319||95.0|0.76|1.71||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||1.71|0.76|0.5319
71137163|NCT01272232|141776151|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.61|||<|0.0001||95.0|6.05|15.26||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||15.26|6.05|<0.0001
71137164|NCT01272232|141776151|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.98|||<|0.0001||95.0|3.59|9.97||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||9.97|3.59|<0.0001
71137165|NCT01272232|141776151|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.0142||95.0|1.1|2.34||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||2.34|1.10|0.0142
71137166|NCT01272232|141776152|SUPERIORITY_OR_OTHER||Treatment contrast|-3.22|||<|0.0001||95.0|-4.2|-2.23||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-2.23|-4.20|<0.0001
70863492|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.16||0.771|TWO_SIDED|95.0|-0.26|0.35|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.35|-0.26|0.771
71137167|NCT01272232|141776152|SUPERIORITY_OR_OTHER||Treatment contrast|-2.06||||0.0004||95.0|-3.2|-0.92||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.92|-3.20|0.0004
71137168|NCT01272232|141776152|SUPERIORITY_OR_OTHER||Treatment contrast|-1.16||||0.0224||95.0|-2.16|-0.16||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.16|-2.16|0.0224
71137169|NCT01272232|141776153|SUPERIORITY_OR_OTHER||Treatment contrast|-2.17||||0.0002||95.0|-3.32|-1.02||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-1.02|-3.32|0.0002
71137170|NCT01272232|141776153|SUPERIORITY_OR_OTHER||Treatment contrast|-1.2||||0.0725||95.0|-2.51|0.11||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||0.11|-2.51|0.0725
71137171|NCT01272232|141776153|SUPERIORITY_OR_OTHER||Treatment contrast|-0.97||||0.0717||95.0|-2.02|0.09||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||0.09|-2.02|0.0717
71137172|NCT01272232|141776155|SUPERIORITY_OR_OTHER||Treatment contrast|-2.49|||<|0.0001||95.0|-3.75|-1.24||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-1.24|-3.75|<0.0001
71137173|NCT01272232|141776155|SUPERIORITY_OR_OTHER||Treatment contrast|-1.47||||0.0457||95.0|-2.92|-0.03||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.03|-2.92|0.0457
71137174|NCT01272232|141776155|SUPERIORITY_OR_OTHER||Treatment contrast|-1.02||||0.0961||95.0|-2.22|0.18||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||0.18|-2.22|0.0961
71137175|NCT00628030|141776173|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Chi-squared|||||||.008
71137176|NCT00628030|141776174|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED||||||Chi-squared|||||||.041
71137177|NCT00628030|141776175|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Chi-squared|||||||.61
71137178|NCT00628030|141776176|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Chi-squared|||||||0.13
71137179|NCT00628030|141776177|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED||||||Chi-squared|||||||.024
71137180|NCT00890825|141776228|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.2069|TWO_SIDED|80.0|0.56|1.14||One-sided p-value. The p-value is associated with the point estimate (e.g. HR comparing AZD6244 + Docetaxel vs Placebo + Docetaxel) on the outcome measure - Overall survival.|Regression, Cox|Analysis adjusted for the following covariates; WHO PS, gender, histology and smoking status|A Hazard Ratio less than 1 favoured AZD6244 + Docetaxel|||1.14|0.56|0.2069
71137181|NCT00890825|141776229|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.0138|TWO_SIDED|80.0|0.42|0.79||One-sided p-value. The p-value is associated with the point estimate (e.g. HR comparing AZD6244 + Docetaxel vs Placebo + Docetaxel) on the outcome measure.|Regression, Cox|The model allowed for the effect of treatment and included terms for WHO PS, gender, histology, and smoking status.|A Hazard Ratio (HR) \< 1 favoured AZD6244 + Docetaxel|||0.79|0.42|0.0138
71137182|NCT00890825|141776230|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|37.2|||<|0.0001|TWO_SIDED|95.0|23.0|53.0||Two-sided P-value|Fisher Exact|||||53|23|< 0.0001
71137183|NCT00890825|141776232|SUPERIORITY_OR_OTHER||LSmeans difference|-17.03||||0.004|TWO_SIDED|80.0|-25.2|-8.86||One-sided p-value. The p-value is associated with the point estimate comparing AZD6244 + Docetaxel vs Placebo + Docetaxel on the outcome measure.|ANCOVA|LS means were adjusted for baseline tumour size, time from baseline scan to randomisation, WHO PS, gender, histology, and smoking status.|(AZD6244 + Docetaxel) - (Placebo + Docetaxel)|||-8.86|-25.2|0.004
71137184|NCT00890825|141776233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.0||||0.004|TWO_SIDED|80.0|-38.34|-13.7||One-sided p-value. The p-value is associated with the point estimate comparing AZD6244 + Docetaxel vs Placebo + Docetaxel on the outcome measure.|ANCOVA|LS means were adjusted for baseline tumour size, time from baseline scan to randomisation, WHO PS, gender, histology, and smoking status|(AZD6244 + Docetaxel) - (Placebo + Docetaxel)|||-13.7|-38.34|0.004
71137185|NCT00890825|141776234|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.54||||0.0158|TWO_SIDED|80.0|0.37|0.78||One-sided p-value. The p-value is associated with the point estimate (e.g. HR comparing AZD6244 + Docetaxel vs Placebo + Docetaxel) on the outcome measure.|Log Rank|Confidence interval (CI) used Greenwood's formula for the standard error of a survival estimate|A hazard ratio (HR) \<1 favours AZD6244 75 mg bd+Docetaxel|||0.78|0.37|0.0158
71137186|NCT01216202|141776255|SUPERIORITY|||||||0.014||||||The threshold for statistical significance was p = 0.05.|Regression, Linear|||The association between change in serum testosterone levels and cumulative mean testicular radiation dose was assessed using longitudinal regression analysis (GEE). No preoperative RT contributed with baseline values.||||0.014
71137187|NCT01216202|141776256|SUPERIORITY||Estimated mean change|-4.0||||0.008|TWO_SIDED|95.0|-6.9|-1.0||The threshold for statistical significance was p=0.05.|Regression, Linear|Model adjusted for time between preoperative radiotherapy (RT) and surgery.||The association between change in total number of sperms per ejaculate and relative mean testicular dose was assessed using longitudinal regression analysis (GEE).||-1.0|-6.9|0.008
71137188|NCT03483896|141776279|SUPERIORITY||Mean Difference (Final Values)|-3.5||||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.01
71137189|NCT03483896|141776280|SUPERIORITY||Mean Difference (Final Values)|-6.0||||0.17|TWO_SIDED||||||Mixed Models Analysis|||||||0.17
71137190|NCT02365649|141776281|SUPERIORITY||Adjusted risk difference from placebo|9.9||||0.056|TWO_SIDED|95.0|-0.3|20.1||Statistical significance was prespecified at α = 0.1. Based on Cochran-Mantel-Haenszel (CMH) test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||20.1|-0.3|0.056
71137191|NCT02365649|141776281|SUPERIORITY||Adjusted risk difference from placebo|7.4||||0.108|TWO_SIDED|95.0|-1.6|16.4||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||16.4|-1.6|0.108
71137192|NCT02365649|141776281|SUPERIORITY||Adjusted risk difference from placebo|7.7||||0.099|TWO_SIDED|95.0|-1.5|16.8||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||16.8|-1.5|0.099
71137193|NCT02365649|141776281|SUPERIORITY||Adjusted risk difference from placebo|21.0||||0.004|TWO_SIDED|95.0|6.8|35.2||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||35.2|6.8|0.004
71137194|NCT02365649|141776281|SUPERIORITY||Adjusted risk difference from placebo|13.6||||0.025|TWO_SIDED|95.0|1.8|25.5||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||25.5|1.8|0.025
71137195|NCT02365649|141776282|SUPERIORITY||Adjusted risk difference from placebo|2.5||||0.74|TWO_SIDED|95.0|-12.3|17.3||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||17.3|-12.3|0.74
71137196|NCT02365649|141776282|SUPERIORITY||Adjusted risk difference from placebo|16.2||||0.082|TWO_SIDED|95.0|-2.0|34.3||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||34.3|-2.0|0.082
71137197|NCT02365649|141776282|SUPERIORITY||Adjusted risk difference from placebo|0.5||||0.952|TWO_SIDED|95.0|-14.1|15.0||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||15.0|-14.1|0.952
71137198|NCT02365649|141776282|SUPERIORITY||Adjusted risk difference from placebo|11.2||||0.205|TWO_SIDED|95.0|-6.1|28.5||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||28.5|-6.1|0.205
71137199|NCT02365649|141776282|SUPERIORITY||Adjusted risk difference from placebo|4.1||||0.607|TWO_SIDED|95.0|-11.5|19.6||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||19.6|-11.5|0.607
71137200|NCT02365649|141776283|SUPERIORITY||Adjusted risk difference from placebo|5.2||||0.564|TWO_SIDED|95.0|-12.5|22.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||22.9|-12.5|0.564
71137201|NCT02365649|141776283|SUPERIORITY||Adjusted risk difference from placebo|12.0||||0.221|TWO_SIDED|95.0|-7.2|31.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||31.2|-7.2|0.221
71137202|NCT02365649|141776283|SUPERIORITY||Adjusted risk difference from placebo|22.2||||0.036|TWO_SIDED|95.0|1.4|43.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||43|1.4|0.036
71137203|NCT02365649|141776283|SUPERIORITY||Adjusted risk difference from placebo|13.4||||0.179|TWO_SIDED|95.0|-6.2|33.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||33.1|-6.2|0.179
71137204|NCT02365649|141776283|SUPERIORITY||Adjusted risk difference from placebo|3.9||||0.677|TWO_SIDED|95.0|-14.3|22.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||22|-14.3|0.677
71137205|NCT02365649|141776284|SUPERIORITY||Adjusted risk difference from placebo|10.4||||0.363|TWO_SIDED|95.0|-12.0|32.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||32.9|-12|0.363
71137206|NCT02365649|141776284|SUPERIORITY||Adjusted risk difference from placebo|17.3||||0.137|TWO_SIDED|95.0|-5.5|40.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||40|-5.5|0.137
71137207|NCT02365649|141776284|SUPERIORITY||Adjusted risk difference from placebo|7.5||||0.512|TWO_SIDED|95.0|-14.9|29.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||29.9|-14.9|0.512
71137208|NCT02365649|141776284|SUPERIORITY||Adjusted risk difference from placebo|25.0||||0.035|TWO_SIDED|95.0|-1.8|48.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||48.2|-1.8|0.035
71137209|NCT02365649|141776284|SUPERIORITY||Adjusted risk difference from placebo|12.5||||0.29|TWO_SIDED|95.0|-10.7|35.6||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||35.6|-10.7|0.29
71137210|NCT02365649|141776285|SUPERIORITY||Adjusted risk difference from placebo|-0.9||||0.896|TWO_SIDED|95.0|-15.0|13.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||13.1|-15.0|0.896
71137211|NCT02365649|141776285|SUPERIORITY||Adjusted risk difference from placebo|18.6||||0.05|TWO_SIDED|95.0|0.0|37.3||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||37.3|0.0|0.05
71137212|NCT02365649|141776285|SUPERIORITY||Adjusted risk difference from placebo|3.0||||0.702|TWO_SIDED|95.0|-12.4|18.4||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||18.4|-12.4|0.702
71137213|NCT02365649|141776285|SUPERIORITY||Adjusted risk difference from placebo|14.3||||0.117|TWO_SIDED|95.0|-3.6|32.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||32.2|-3.6|0.117
71137214|NCT02365649|141776285|SUPERIORITY||Adjusted risk difference from placebo|-2.4||||0.736|TWO_SIDED|95.0|-16.4|11.6||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||11.6|-16.4|0.736
71137215|NCT02365649|141776286|SUPERIORITY||Adjusted risk difference from placebo|2.9||||0.276|TWO_SIDED|95.0|-2.3|8.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||8.1|-2.3|0.276
71137216|NCT02365649|141776286|SUPERIORITY||Adjusted risk difference from placebo|4.9||||0.195|TWO_SIDED|95.0|-2.5|12.4||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||12.4|-2.5|0.195
70863493|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.16||0.032|TWO_SIDED|95.0|0.03|0.64|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.64|0.03|0.032
71137217|NCT02365649|141776286|SUPERIORITY||Adjusted risk difference from placebo|2.6||||0.355|TWO_SIDED|95.0|-2.9|8.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||8.0|-2.9|0.355
70863494|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.17||0.223|TWO_SIDED|95.0|-0.13|0.54|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.54|-0.13|0.223
71137218|NCT02365649|141776286|SUPERIORITY||Adjusted risk difference from placebo|7.7||||0.099|TWO_SIDED|95.0|-1.5|16.8||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||16.8|-1.5|0.099
71137219|NCT02365649|141776286|SUPERIORITY||Adjusted risk difference from placebo|5.2||||0.185|TWO_SIDED|95.0|-2.5|12.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||12.9|-2.5|0.185
71137220|NCT02365649|141776287|SUPERIORITY||Adjusted risk difference from placebo|13.2||||0.05|TWO_SIDED|95.0|0.0|26.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||26.5|0.0|0.05
71137221|NCT02365649|141776287|SUPERIORITY||Adjusted risk difference from placebo|29.5||||0.001|TWO_SIDED|95.0|11.9|47.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||47.1|11.9|0.001
71137222|NCT02365649|141776287|SUPERIORITY||Adjusted risk difference from placebo|25.2||||0.003|TWO_SIDED|95.0|8.5|42.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||42.0|8.5|0.003
71137223|NCT02365649|141776287|SUPERIORITY||Adjusted risk difference from placebo|36.5|||<|0.001|TWO_SIDED|95.0|17.6|55.4||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||55.4|17.6|< 0.001
70863495|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.17||0.718|TWO_SIDED|95.0|-0.39|0.27|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.27|-0.39|0.718
70863496|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.17||0.495|TWO_SIDED|95.0|-0.45|0.22|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.45|0.495
71137224|NCT02365649|141776287|SUPERIORITY||Adjusted risk difference from placebo|32.0|||<|0.001|TWO_SIDED|95.0|13.9|50.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||50.2|13.9|< 0.001
70863497|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.17||0.371|TWO_SIDED|95.0|-0.18|0.49|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.49|-0.18|0.371
70863498|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.16||0.647|TWO_SIDED|95.0|-0.4|0.25|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.25|-0.40|0.647
71137225|NCT02365649|141776288|SUPERIORITY||Adjusted risk difference from placebo|10.5||||0.243|TWO_SIDED|95.0|-7.2|28.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||28.2|-7.2|0.243
70863499|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.073|TWO_SIDED|95.0|-0.62|0.03|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.62|0.073
70863500|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.16||0.161|TWO_SIDED|95.0|-0.55|0.09|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.55|0.161
71137226|NCT02365649|141776288|SUPERIORITY||Adjusted risk difference from placebo|29.1||||0.006|TWO_SIDED|95.0|8.3|49.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||49.9|8.3|0.006
71137227|NCT02365649|141776288|SUPERIORITY||Adjusted risk difference from placebo|24.2||||0.017|TWO_SIDED|95.0|4.4|44.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||44.1|4.4|0.017
71137228|NCT02365649|141776288|SUPERIORITY||Adjusted risk difference from placebo|36.5|||<|0.001|TWO_SIDED|95.0|14.8|58.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||58.1|14.8|< 0.001
71137229|NCT02365649|141776288|SUPERIORITY||Adjusted risk difference from placebo|36.8|||<|0.001|TWO_SIDED|95.0|15.2|58.3||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||58.3|15.2|< 0.001
71137230|NCT02365649|141776289|SUPERIORITY||Adjusted risk difference from placebo|10.5||||0.353|TWO_SIDED|95.0|-11.7|32.7||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||32.7|-11.7|0.353
71137231|NCT02365649|141776289|SUPERIORITY||Adjusted risk difference from placebo|22.7||||0.05|TWO_SIDED|95.0|0.0|45.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||45.5|0.0|0.05
71137232|NCT02365649|141776289|SUPERIORITY||Adjusted risk difference from placebo|12.5||||0.268|TWO_SIDED|95.0|-9.6|34.6||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||34.6|-9.6|0.268
71137233|NCT02365649|141776289|SUPERIORITY||Adjusted risk difference from placebo|28.0||||0.018|TWO_SIDED|95.0|4.8|51.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||51.2|4.8|0.018
71137234|NCT02365649|141776289|SUPERIORITY||Adjusted risk difference from placebo|14.9||||0.204|TWO_SIDED|95.0|-8.1|37.8||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||37.8|-8.1|0.204
71137235|NCT02365649|141776290|SUPERIORITY||Adjusted risk difference from placebo|10.0||||0.421|TWO_SIDED|95.0|-14.4|34.4||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||34.4|-14.4|0.421
71137236|NCT02365649|141776290|SUPERIORITY||Adjusted risk difference from placebo|11.5||||0.371|TWO_SIDED|95.0|-13.8|36.8||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||36.8|-13.8|0.371
71137237|NCT02365649|141776290|SUPERIORITY||Adjusted risk difference from placebo|9.2||||0.445|TWO_SIDED|95.0|-14.4|32.8||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||32.8|-14.4|0.445
70863501|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.16||0.961|TWO_SIDED|95.0|-0.33|0.32|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.32|-0.33|0.961
71137238|NCT02365649|141776290|SUPERIORITY||Adjusted risk difference from placebo|19.5||||0.198|TWO_SIDED|95.0|-10.2|49.3||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||49.3|-10.2|0.198
71137239|NCT02365649|141776290|SUPERIORITY||Adjusted risk difference from placebo|5.0||||0.654|TWO_SIDED|95.0|-17.0|27.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||27.0|-17.0|0.654
71137240|NCT02365649|141776291|SUPERIORITY||Adjusted risk difference from placebo|18.7||||0.093|TWO_SIDED|95.0|-3.1|40.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||40.5|-3.1|0.093
71137241|NCT02365649|141776291|SUPERIORITY||Adjusted risk difference from placebo|13.5||||0.176|TWO_SIDED|95.0|-6.1|33.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||33.1|-6.1|0.176
71137242|NCT02365649|141776291|SUPERIORITY||Adjusted risk difference from placebo|35.9||||0.017|TWO_SIDED|95.0|6.3|65.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||65.5|6.3|0.017
71137243|NCT02365649|141776291|SUPERIORITY||Adjusted risk difference from placebo|26.1||||0.044|TWO_SIDED|95.0|0.7|51.5|||Cochran-Mantel-Haenszel|||||51.5|0.7|0.044
71137244|NCT02365649|141776291|SUPERIORITY||Adjusted risk difference from placebo|13.1||||0.121|TWO_SIDED|95.0|-3.5|29.6||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||29.6|-3.5|0.121
71137245|NCT02365649|141776292|SUPERIORITY||Adjusted risk difference from placebo|3.4||||0.564|TWO_SIDED|95.0|-8.1|14.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||14.9|-8.1|0.564
71137246|NCT02365649|141776292|SUPERIORITY||Adjusted risk difference from placebo|3.4||||0.584|TWO_SIDED|95.0|-8.8|15.7||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||15.7|-8.8|0.584
71137247|NCT02365649|141776292|SUPERIORITY||Adjusted risk difference from placebo|8.7||||0.326|TWO_SIDED|95.0|-8.7|26.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||26.1|-8.7|0.326
71137248|NCT02365649|141776293|SUPERIORITY||Adjusted risk difference from placebo|12.2||||0.195|TWO_SIDED|95.0|-6.2|30.7||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||30.7|-6.2|0.195
71137249|NCT02365649|141776293|SUPERIORITY||Adjusted risk difference from placebo|17.9||||0.116|TWO_SIDED|95.0|-4.4|40.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||40.1|-4.4|0.116
71137250|NCT02365649|141776293|SUPERIORITY||Adjusted risk difference from placebo|12.8||||0.178|TWO_SIDED|95.0|-5.8|31.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||31.5|-5.8|0.178
71137251|NCT02365649|141776293|SUPERIORITY||Adjusted risk difference from placebo|30.4||||0.031|TWO_SIDED|95.0|2.8|58.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||58.0|2.8|0.031
71137252|NCT02365649|141776293|SUPERIORITY||Adjusted risk difference from placebo|13.1||||0.121|TWO_SIDED|95.0|-3.5|29.6||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||29.6|-3.5|0.121
71137253|NCT02365649|141776294|SUPERIORITY||Adjusted risk difference from placebo|6.8||||0.392|TWO_SIDED|95.0|-8.7|22.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||22.2|-8.7|0.392
71137254|NCT02365649|141776294|SUPERIORITY||Adjusted risk difference from placebo|3.4||||0.584|TWO_SIDED|95.0|-8.8|15.7||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||15.7|-8.8|0.584
71137255|NCT02365649|141776294|SUPERIORITY||Adjusted risk difference from placebo|13.0||||0.199|TWO_SIDED|95.0|-6.8|32.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||32.9|-6.8|0.199
71137256|NCT02365649|141776294|SUPERIORITY||Adjusted risk difference from placebo|6.9||||0.439|TWO_SIDED|95.0|-10.6|24.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||24.5|-10.6|0.439
71137257|NCT02365649|141776295|SUPERIORITY||LS Mean Difference|-103.9||||0.788|TWO_SIDED|95.0|-865.69|657.87||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 4||657.87|-865.69|0.788
71137258|NCT02365649|141776295|SUPERIORITY||LS Mean Difference|-364.3||||0.325|TWO_SIDED|95.0|-1092.83|364.29||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 4||364.29|-1092.83|0.325
71137259|NCT02365649|141776295|SUPERIORITY||LS Mean Difference|-926.2||||0.015|TWO_SIDED|95.0|-1672.78|-179.63||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||-179.63|-1672.78|0.015
71137260|NCT02365649|141776295|SUPERIORITY||LS Mean Difference|-763.1||||0.053|TWO_SIDED|95.0|-1534.52|8.39||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 4||8.39|-1534.52|0.053
71137261|NCT02365649|141776295|SUPERIORITY||LS Mean Difference|-359.5||||0.352|TWO_SIDED|95.0|-1119.52|400.56||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 4||400.56|-1119.52|0.352
71137262|NCT02365649|141776295|SUPERIORITY||LS Mean Difference|-396.2||||0.503|TWO_SIDED|95.0|-1565.39|772.9||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||772.90|-1565.39|0.503
71137263|NCT02365649|141776295|SUPERIORITY||LS Mean Difference|-364.3||||0.537|TWO_SIDED|95.0|-1531.04|802.44||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||802.44|-1531.04|0.537
71137264|NCT02365649|141776295|SUPERIORITY||LS Mean Difference|-483.2||||0.425|TWO_SIDED|95.0|-1677.87|711.52||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||711.52|-1677.87|0.425
71137265|NCT02365649|141776295|SUPERIORITY||LS Mean Difference|-1025.6||||0.134|TWO_SIDED|95.0|-2373.24|322.08||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||322.08|-2373.24|0.134
71137266|NCT02365649|141776295|SUPERIORITY||LS Mean Difference|-637.9||||0.293|TWO_SIDED|95.0|-1833.82|557.96||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||557.96|-1833.82|0.293
71137267|NCT02365649|141776296|SUPERIORITY||LS Mean Difference|0.5||||0.921|TWO_SIDED|95.0|-9.02|9.97||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||9.97|-9.02|0.921
71137268|NCT02365649|141776296|SUPERIORITY||LS Mean Difference|-1.6||||0.75|TWO_SIDED|95.0|-11.19|8.08||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||8.08|-11.19|0.75
71137269|NCT02365649|141776296|SUPERIORITY||LS Mean Difference|-1.9||||0.7|TWO_SIDED|95.0|-11.7|7.87||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||7.87|-11.7|0.7
71137270|NCT02365649|141776296|SUPERIORITY||LS Mean Difference|-11.4||||0.024|TWO_SIDED|95.0|-21.38|-1.51||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||-1.51|-21.38|0.024
71137271|NCT02365649|141776296|SUPERIORITY||LS Mean Difference|-1.0||||0.845|TWO_SIDED|95.0|-10.72|8.79||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||8.79|-10.72|0.845
70863502|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.18||0.697|TWO_SIDED|95.0|-0.42|0.28|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.42|0.697
71137272|NCT02365649|141776297|SUPERIORITY||LS Mean Difference|1.7||||0.83|TWO_SIDED|95.0|-13.6|16.92||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 8||16.92|-13.60|0.830
71137273|NCT02365649|141776297|SUPERIORITY||LS Mean Difference|17.5||||0.027|TWO_SIDED|95.0|2.03|33.0||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 8||33.00|2.03|0.027
71137274|NCT02365649|141776297|SUPERIORITY||LS Mean Difference|8.9||||0.263|TWO_SIDED|95.0|-6.72|24.47||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 8||24.47|-6.72|0.263
71137275|NCT02365649|141776297|SUPERIORITY||LS Mean Difference|21.6||||0.008|TWO_SIDED|95.0|5.68|37.52||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 8||37.52|5.68|0.008
71137276|NCT02365649|141776297|SUPERIORITY||LS Mean Difference|8.8||||0.269|TWO_SIDED|95.0|-6.88|24.53||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 8||24.53|-6.88|0.269
71137277|NCT02365649|141776297|SUPERIORITY||LS Mean Difference|10.3||||0.231|TWO_SIDED|95.0|-6.63|27.25||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||27.25|-6.63|0.231
71137278|NCT02365649|141776297|SUPERIORITY||LS Mean Difference|27.9||||0.002|TWO_SIDED|95.0|10.68|45.15||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||45.15|10.68|0.002
71137279|NCT02365649|141776297|SUPERIORITY||LS Mean Difference|17.1||||0.057|TWO_SIDED|95.0|-0.51|34.72||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||34.72|-0.51|0.057
71137280|NCT02365649|141776297|SUPERIORITY||LS Mean Difference|28.8||||0.002|TWO_SIDED|95.0|11.12|46.56||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||46.56|11.12|0.002
71137281|NCT02365649|141776297|SUPERIORITY||LS Mean Difference|12.3||||0.165|TWO_SIDED|95.0|-5.12|29.72||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||29.72|-5.12|0.165
71137282|NCT02365649|141776298|SUPERIORITY||Adjusted risk difference from placebo|20.0||||0.167|TWO_SIDED|95.0|-8.4|48.4||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||48.4|-8.4|0.167
71137283|NCT02365649|141776298|SUPERIORITY||Adjusted risk difference from placebo|16.7||||0.221|TWO_SIDED|95.0|-10.0|43.3||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||43.3|-10.0|0.221
71137284|NCT02365649|141776298|SUPERIORITY||Adjusted risk difference from placebo|20.0||||0.18|TWO_SIDED|95.0|-9.2|49.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||49.2|-9.2|0.18
71137285|NCT02365649|141776298|SUPERIORITY||LS Mean Difference|20.0||||0.167|TWO_SIDED|95.0|-8.4|48.4||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||48.4|-8.4|0.167
71137286|NCT02365649|141776299|SUPERIORITY||Adjusted risk difference from placebo|5.5||||0.607|TWO_SIDED|95.0|-15.5|26.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||26.5|-15.5|0.607
71137287|NCT02365649|141776299|SUPERIORITY||Adjusted risk difference from placebo|12.2||||0.272|TWO_SIDED|95.0|-9.6|33.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||33.9|-9.6|0.272
71137288|NCT02365649|141776299|SUPERIORITY||Adjusted risk difference from placebo|15.9||||-0.157|TWO_SIDED|95.0|-6.1|37.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||37.9|-6.1|-0.157
71137289|NCT02365649|141776299|SUPERIORITY||LS Mean Difference|27.7||||0.017|TWO_SIDED|95.0|4.9|50.6||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||50.6|4.9|0.017
71137290|NCT02365649|141776299|SUPERIORITY||Adjusted risk difference from placebo|2.8||||0.798|TWO_SIDED|95.0|-18.4|23.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||23.9|-18.4|0.798
71137291|NCT02365649|141776300|SUPERIORITY||Adjusted risk difference from placebo|9.8||||0.119|TWO_SIDED|95.0|-2.5|22.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||22.1|-2.5|0.119
71137292|NCT02365649|141776300|SUPERIORITY||Adjusted risk difference from placebo|15.4||||0.034|TWO_SIDED|95.0|1.1|29.7||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||29.7|1.1|0.034
71137293|NCT02365649|141776300|SUPERIORITY||Adjusted risk difference from placebo|23.2||||0.004|TWO_SIDED|95.0|7.3|39.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||39.2|7.3|0.004
71137294|NCT02365649|141776300|SUPERIORITY||Adjusted risk difference from placebo|32.4|||<|0.001|TWO_SIDED|95.0|14.2|50.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||50.5|14.2|< 0.001
71137295|NCT02365649|141776300|SUPERIORITY||Adjusted risk difference from placebo|22.9|||<|0.006|TWO_SIDED|95.0|6.6|39.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||39.2|6.6|< 0.006
71137296|NCT02365649|141776301|SUPERIORITY||Adjusted risk difference from placebo|3.9||||0.647|TWO_SIDED|95.0|-12.7|20.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||20.5|-12.7|0.647
71137297|NCT02365649|141776301|SUPERIORITY||Adjusted risk difference from placebo|17.1||||0.093|TWO_SIDED|95.0|-2.9|37.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||37.1|-2.9|0.093
71137298|NCT02365649|141776301|SUPERIORITY||Adjusted risk difference from placebo|13.6||||0.165|TWO_SIDED|95.0|-5.6|32.8||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||32.8|-5.6|0.165
71137299|NCT02365649|141776301|SUPERIORITY||Adjusted risk difference from placebo|24.9||||0.023|TWO_SIDED|95.0|3.4|46.3||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||46.3|3.4|0.023
71137300|NCT02365649|141776301|SUPERIORITY||Adjusted risk difference from placebo|7.0||||0.448|TWO_SIDED|95.0|-11.0|25.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||25.0|-11.0|0.448
71137301|NCT02365649|141776302|SUPERIORITY||LS Mean Difference|0.4||||0.412|TWO_SIDED|95.0|-0.62|1.5||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||1.5|-0.62|0.412
71137302|NCT02365649|141776302|SUPERIORITY||LS Mean Difference|-1.4||||0.01|TWO_SIDED|95.0|-2.47|-0.34||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||-0.34|-2.47|0.01
71137303|NCT02365649|141776302|SUPERIORITY||LS Mean Difference|-1.0||||0.082|TWO_SIDED|95.0|-2.13|0.13||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||0.13|-2.13|0.082
71137304|NCT02365649|141776302|SUPERIORITY||LS Mean Difference|-1.6||||0.004|TWO_SIDED|95.0|-2.73|-0.52||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||-0.52|-2.73|0.004
71137305|NCT02365649|141776302|SUPERIORITY||LS Mean Difference|0.2||||0.766|TWO_SIDED|95.0|-0.93|1.26||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||1.26|-0.93|0.766
70863503|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.18||0.139|TWO_SIDED|95.0|-0.62|0.09|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.62|0.139
70863504|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.18||0.12|TWO_SIDED|95.0|-0.64|0.07|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.07|-0.64|0.120
70863505|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.18||0.637|TWO_SIDED|95.0|-0.44|0.27|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.27|-0.44|0.637
71137306|NCT02365649|141776303|SUPERIORITY||LS Mean Difference|-0.6||||0.314|TWO_SIDED|95.0|-1.75|0.56||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||0.56|-1.75|0.314
71137307|NCT02365649|141776303|SUPERIORITY||LS Mean Difference|-1.8||||0.002|TWO_SIDED|95.0|-3.01|-0.68||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||-0.68|-3.01|0.002
70863506|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.17||0.028|TWO_SIDED|95.0|-0.72|-0.04|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.72|0.028
71137308|NCT02365649|141776303|SUPERIORITY||LS Mean Difference|-0.7||||0.255|TWO_SIDED|95.0|-1.94|0.52||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||0.52|-1.94|0.255
70863507|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.17||0.024|TWO_SIDED|95.0|-0.74|-0.05|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.05|-0.74|0.024
70863508|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.17||0.339|TWO_SIDED|95.0|-0.51|0.17|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.51|0.339
70863509|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.17||0.381|TWO_SIDED|95.0|-0.5|0.19|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.50|0.381
70863510|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.19||0.438|TWO_SIDED|95.0|-0.51|0.22|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.51|0.438
70863511|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.111|TWO_SIDED|95.0|-0.66|0.07|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.07|-0.66|0.111
70863512|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.19||0.059|TWO_SIDED|95.0|-0.72|0.01|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.72|0.059
70863513|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.282|TWO_SIDED|95.0|-0.57|0.17|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.57|0.282
70863514|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.18||0.927|TWO_SIDED|95.0|-0.37|0.33|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.33|-0.37|0.927
70863515|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.094|TWO_SIDED|95.0|-0.65|0.05|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.65|0.094
70863516|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.012|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.10|-0.80|0.012
70863517|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.18||0.363|TWO_SIDED|95.0|-0.51|0.19|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.51|0.363
70863518|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.2||0.742|TWO_SIDED|95.0|-0.32|0.45|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.45|-0.32|0.742
71137309|NCT02365649|141776303|SUPERIORITY||LS Mean Difference|-1.4||||0.022|TWO_SIDED|95.0|-2.61|-0.2||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||-0.2|-2.61|0.022
70863519|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.19||0.436|TWO_SIDED|95.0|-0.53|0.23|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.53|0.436
70863520|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.2||0.038|TWO_SIDED|95.0|-0.79|-0.02|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.02|-0.79|0.038
70863521|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.332|TWO_SIDED|95.0|-0.57|0.19|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.57|0.332
70863522|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.16||0.284|TWO_SIDED|95.0|-0.47|0.14|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.14|-0.47|0.284
70863523|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.16||0.224|TWO_SIDED|95.0|-0.5|0.12|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.50|0.224
70863524|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.16||0.002|TWO_SIDED|95.0|-0.79|-0.17|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.17|-0.79|0.002
70863525|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.16||0.355|TWO_SIDED|95.0|-0.45|0.16|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.16|-0.45|0.355
70863526|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.17||0.172|TWO_SIDED|95.0|-0.57|0.1|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.10|-0.57|0.172
70863527|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.17||0.882|TWO_SIDED|95.0|-0.36|0.31|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.31|-0.36|0.882
70863528|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.17||0.084|TWO_SIDED|95.0|-0.63|0.04|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.63|0.084
70863529|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.17||0.405|TWO_SIDED|95.0|-0.47|0.19|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.47|0.405
70863530|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-0.99|-0.34|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.34|-0.99|<0.001
70863531|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.06|-0.42|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.42|-1.06|<0.001
70863532|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.29|-0.64|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.64|-1.29|<0.001
70863533|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.29|-0.65|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.65|-1.29|<0.001
71137310|NCT02365649|141776303|SUPERIORITY||LS Mean Difference|-0.7||||0.239|TWO_SIDED|95.0|-1.92|0.48||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||0.48|-1.92|0.239
71137311|NCT02365649|141776304|SUPERIORITY||Risk Difference (RD)|-7.5||||1|TWO_SIDED|95.0|-36.4|21.4||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders||21.4|-36.4|1.000
71137312|NCT02365649|141776304|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-22.5|32.5||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders||32.5|-22.5|1.000
71137313|NCT02365649|141776304|SUPERIORITY||Risk Difference (RD)|-20.0||||0.272|TWO_SIDED|95.0|-37.5|-2.5||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders||-2.5|-37.5|0.272
71137314|NCT02365649|141776304|SUPERIORITY||Risk Difference (RD)|2.9||||1|TWO_SIDED|95.0|-2.7|8.6||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders||8.6|-2.7|1.000
71137315|NCT02365649|141776304|SUPERIORITY||Risk Difference (RD)|13.0||||0.068|TWO_SIDED|95.0|-0.7|26.8||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders||26.8|-0.7|0.068
71137316|NCT02365649|141776304|SUPERIORITY||Risk Difference (RD)|-5.4||||1|TWO_SIDED|95.0|-23.1|12.3||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders||12.3|-23.1|1.0000
71137317|NCT02365649|141776304|SUPERIORITY||Risk Difference (RD)|1.3||||1|TWO_SIDED|95.0|-15.7|18.3||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders||18.3|-15.7|1.000
71137318|NCT02365649|141776304|SUPERIORITY||Risk Difference (RD)|3.3||||1|TWO_SIDED|95.0|-16.7|23.3||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders||23.3|-16.7|1.000
71137319|NCT02365649|141776304|SUPERIORITY||Risk Difference (RD)|4.8||||1|TWO_SIDED|95.0|-4.3|13.9||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders||13.9|-4.3|1.000
71137320|NCT02365649|141776305|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-35.5|35.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||35.5|-35.5|1.000
71137321|NCT02365649|141776305|SUPERIORITY||Risk Difference (RD)|12.5||||0.483|TWO_SIDED|95.0|-17.9|42.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||42.9|-17.9|0.483
71137322|NCT02365649|141776305|SUPERIORITY||Risk Difference (RD)|-15.0||||0.633|TWO_SIDED|95.0|-41.6|11.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||11.6|-41.6|0.633
71137323|NCT02365649|141776305|SUPERIORITY||Risk Difference (RD)|6.9||||0.424|TWO_SIDED|95.0|-12.7|26.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||26.4|-12.7|0.424
71137324|NCT02365649|141776305|SUPERIORITY||Risk Difference (RD)|5.7||||0.614|TWO_SIDED|95.0|-5.6|17.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||17.0|-5.6|0.614
70863534|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-0.95|-0.25|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.25|-0.95|<0.001
71137325|NCT02365649|141776305|SUPERIORITY||Risk Difference (RD)|14.3||||0.149|TWO_SIDED|95.0|-2.4|30.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||30.9|-2.4|0.149
71137326|NCT02365649|141776305|SUPERIORITY||Risk Difference (RD)|5.8||||0.684|TWO_SIDED|95.0|-19.1|30.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||30.7|-19.1|0.684
71137327|NCT02365649|141776305|SUPERIORITY||Risk Difference (RD)|8.5||||0.404|TWO_SIDED|95.0|-11.5|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||28.5|-11.5|0.404
70863535|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.02|-0.32|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.32|-1.02|<0.001
71137328|NCT02365649|141776305|SUPERIORITY||Risk Difference (RD)|10.7||||0.47|TWO_SIDED|95.0|-12.8|34.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||34.1|-12.8|0.470
71137329|NCT02365649|141776305|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||4.6|-14.6|1.000
71137330|NCT02365649|141776305|SUPERIORITY||Risk Difference (RD)|4.5||||1|TWO_SIDED|95.0|-11.3|20.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||20.3|-11.3|1.000
71137331|NCT02365649|141776305|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||4.6|-14.6|1.000
71137332|NCT02365649|141776306|SUPERIORITY||Risk Difference (RD)|-16.9||||0.624|TWO_SIDED|95.0|-48.4|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||14.6|-48.4|0.624
71137333|NCT02365649|141776306|SUPERIORITY||Risk Difference (RD)|3.9||||1|TWO_SIDED|95.0|-28.3|36.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||36.1|-28.3|1.000
71137334|NCT02365649|141776306|SUPERIORITY||Risk Difference (RD)|-19.4||||0.363|TWO_SIDED|95.0|-48.0|9.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||9.1|-48.0|0.363
71137335|NCT02365649|141776306|SUPERIORITY||Risk Difference (RD)|6.1||||0.495|TWO_SIDED|95.0|-2.1|14.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||14.2|-2.1|0.495
71137336|NCT02365649|141776306|SUPERIORITY||Risk Difference (RD)|15.0||||0.066|TWO_SIDED|95.0|-0.6|30.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||30.6|-0.6|0.066
70863536|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.22|-0.51|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.51|-1.22|<0.001
70863537|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.31|-0.6|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.60|-1.31|<0.001
70863538|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.17||0.003|TWO_SIDED|95.0|-0.86|-0.18|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.18|-0.86|0.003
70863539|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.24|-0.56|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.56|-1.24|<0.001
70863540|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.26|-0.57|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.57|-1.26|<0.001
70863541|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.41|-0.73|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.73|-1.41|<0.001
70863542|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.06|-0.33|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.33|-1.06|<0.001
70863543|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.21|-0.47|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.47|-1.21|<0.001
70863544|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.36|-0.63|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.63|-1.36|<0.001
70863545|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.56|-0.83|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.83|-1.56|<0.001
70863546|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.18||0.001|TWO_SIDED|95.0|-0.93|-0.23|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.23|-0.93|0.001
70863547|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.24|-0.53|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.53|-1.24|<0.001
70863548|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.24|-0.53|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.53|-1.24|<0.001
70863549|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.4|-0.7|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.70|-1.40|<0.001
70863550|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.17|-0.4|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.40|-1.17|<0.001
71137337|NCT02365649|141776306|SUPERIORITY||Risk Difference (RD)|-10.7||||0.645|TWO_SIDED|95.0|-30.3|8.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||8.9|-30.3|0.645
71137338|NCT02365649|141776306|SUPERIORITY||Risk Difference (RD)|4.4||||0.686|TWO_SIDED|95.0|-16.8|25.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||25.5|-16.8|0.686
70863551|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.11|-0.34|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.34|-1.11|<0.001
70863552|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.32|-0.56|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.56|-1.32|<0.001
70863553|NCT00809354|141213033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.51|-0.75|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.75|-1.51|<0.001
71137339|NCT02365649|141776306|SUPERIORITY||Risk Difference (RD)|4.4||||0.721|TWO_SIDED|95.0|-19.5|28.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||28.2|-19.5|0.721
70863554|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.16||0.887|TWO_SIDED|95.0|-0.33|0.28|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.33|0.887
70863555|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.16||0.046|TWO_SIDED|95.0|-0.62|-0.01|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.62|0.046
70863556|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.16||0.771|TWO_SIDED|95.0|-0.26|0.35|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.35|-0.26|0.771
70863557|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.16||0.032|TWO_SIDED|95.0|0.03|0.64|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.64|0.03|0.032
70863558|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.17||0.223|TWO_SIDED|95.0|-0.13|0.54|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.54|-0.13|0.223
70863559|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.17||0.718|TWO_SIDED|95.0|-0.39|0.27|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.27|-0.39|0.718
71137340|NCT02365649|141776306|SUPERIORITY||Risk Difference (RD)|4.8||||1|TWO_SIDED|95.0|-4.3|13.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||13.9|-4.3|1.000
71137341|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|-7.5||||1|TWO_SIDED|95.0|-47.5|32.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||32.5|-47.5|1.000
71137342|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|5.0||||0.765|TWO_SIDED|95.0|-27.8|37.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||37.8|-27.8|0.765
71137343|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-42.4|32.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||32.4|-42.4|1.000
71137344|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|-7.5||||1|TWO_SIDED|95.0|-47.5|32.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||32.5|-47.5|1.000
71137345|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|11.3||||0.502|TWO_SIDED|95.0|-21.4|43.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||43.9|-21.4|0.502
71137346|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-32.9|42.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||42.9|-32.9|1.000
71137347|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|-2.5||||1|TWO_SIDED|95.0|-42.3|37.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||37.3|-42.3|1.000
71137348|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|22.5||||0.18|TWO_SIDED|95.0|-9.5|54.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||54.5|-9.5|0.180
71137349|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|-10.0||||0.702|TWO_SIDED|95.0|-45.6|25.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||25.6|-45.6|0.702
71137350|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|-27.5||||0.214|TWO_SIDED|95.0|-58.9|3.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||3.9|-58.9|0.214
71137351|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|28.8||||0.086|TWO_SIDED|95.0|-2.5|60.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||60.0|-2.5|0.086
71137352|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-37.2|37.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||37.2|-37.2|1.000
71137353|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|7.5||||1|TWO_SIDED|95.0|-31.6|46.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||46.6|-31.6|1.000
71137354|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|32.5||||0.051|TWO_SIDED|95.0|1.4|63.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||63.6|1.4|0.051
71137355|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-34.8|34.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||34.8|-34.8|1.000
71137356|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|27.5||||0.075|TWO_SIDED|95.0|-5.0|60.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||60.0|-5.0|0.075
71137357|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|-3.7||||0.705|TWO_SIDED|95.0|-18.6|11.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||11.2|-18.6|0.705
71137358|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|-3.8||||1|TWO_SIDED|95.0|-20.0|12.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||12.4|-20.0|1.000
71137359|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|27.5||||0.075|TWO_SIDED|95.0|-5.0|60.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||60.0|-5.0|0.075
71137360|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|-3.7||||0.705|TWO_SIDED|95.0|-18.6|11.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||11.2|-18.6|0.705
71137361|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|0.5||||1|TWO_SIDED|95.0|-17.4|18.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||18.5|-17.4|1.000
71137362|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|0.6||||1|TWO_SIDED|95.0|-20.5|21.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||21.8|-20.5|1.000
71137363|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|-6.4||||0.348|TWO_SIDED|95.0|-18.0|5.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||5.2|-18.0|0.348
71137364|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|3.7||||0.686|TWO_SIDED|95.0|-13.4|20.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||20.7|-13.4|0.686
71137365|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|7.5||||0.616|TWO_SIDED|95.0|-19.8|34.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||34.8|-19.8|0.616
71137366|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|-6.6||||0.42|TWO_SIDED|95.0|-20.5|7.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||7.3|-20.5|0.420
71137367|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|-3.8||||1|TWO_SIDED|95.0|-20.0|12.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||12.4|-20.0|1.000
71137368|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|0.6||||1|TWO_SIDED|95.0|-20.5|21.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||21.8|-20.5|1.000
71137369|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|-0.6||||1|TWO_SIDED|95.0|-14.4|13.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||13.3|-14.4|1.000
70863560|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.17||0.495|TWO_SIDED|95.0|-0.45|0.22|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.45|0.495
70863561|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.16||0.389|TWO_SIDED|95.0|-0.47|0.18|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.18|-0.47|0.389
70863562|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.17||0.035|TWO_SIDED|95.0|-0.68|-0.02|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.02|-0.68|0.035
70863563|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.16||0.155|TWO_SIDED|95.0|-0.56|0.09|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.56|0.155
70863564|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.17||0.876|TWO_SIDED|95.0|-0.35|0.3|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.30|-0.35|0.876
70863565|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.18||0.864|TWO_SIDED|95.0|-0.33|0.39|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.39|-0.33|0.864
70863566|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.18||0.338|TWO_SIDED|95.0|-0.54|0.18|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.18|-0.54|0.338
70863567|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.101|TWO_SIDED|95.0|-0.66|0.06|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.66|0.101
70863568|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.18||0.605|TWO_SIDED|95.0|-0.46|0.27|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.27|-0.46|0.605
70863569|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.17||0.013|TWO_SIDED|95.0|-0.78|-0.09|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.09|-0.78|0.013
70863570|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.005|TWO_SIDED|95.0|-0.84|-0.15|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.15|-0.84|0.005
70863571|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.17||0.199|TWO_SIDED|95.0|-0.57|0.12|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.57|0.199
70863572|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.18||0.363|TWO_SIDED|95.0|-0.5|0.18|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.18|-0.50|0.363
70863573|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.613|TWO_SIDED|95.0|-0.47|0.28|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.47|0.613
70863574|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.19||0.416|TWO_SIDED|95.0|-0.53|0.22|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.53|0.416
70863575|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.19||0.143|TWO_SIDED|95.0|-0.66|0.09|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.66|0.143
70863576|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.19||0.245|TWO_SIDED|95.0|-0.6|0.15|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.60|0.245
70863577|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.18||0.745|TWO_SIDED|95.0|-0.41|0.29|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.29|-0.41|0.745
70863578|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.18||0.062|TWO_SIDED|95.0|-0.69|0.02|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.69|0.062
70863579|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.18||0.014|TWO_SIDED|95.0|-0.8|-0.09|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.09|-0.80|0.014
70863580|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.18||0.367|TWO_SIDED|95.0|-0.52|0.19|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.52|0.367
70863581|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.995|TWO_SIDED|95.0|-0.39|0.39|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.39|-0.39|0.995
70863582|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.2||0.735|TWO_SIDED|95.0|-0.46|0.32|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.32|-0.46|0.735
70863583|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.2||0.169|TWO_SIDED|95.0|-0.67|0.12|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.67|0.169
70863584|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.2||0.295|TWO_SIDED|95.0|-0.6|0.18|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.18|-0.60|0.295
70863585|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.16||0.284|TWO_SIDED|95.0|-0.47|0.14|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.14|-0.47|0.284
70863586|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.16||0.224|TWO_SIDED|95.0|-0.5|0.12|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.50|0.224
70863587|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.16||0.002|TWO_SIDED|95.0|-0.79|-0.17|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.17|-0.79|0.002
71137370|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|3.7||||0.686|TWO_SIDED|95.0|-13.4|20.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||20.7|-13.4|0.686
71137371|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|9.4||||0.555|TWO_SIDED|95.0|-21.9|40.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||40.6|-21.9|0.555
71137372|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|-2.7||||0.83|TWO_SIDED|95.0|-27.2|21.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||21.8|-27.2|0.830
70863588|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.16||0.355|TWO_SIDED|95.0|-0.45|0.16|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.16|-0.45|0.355
70863589|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.17||0.172|TWO_SIDED|95.0|-0.57|0.1|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.10|-0.57|0.172
70863590|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.17||0.882|TWO_SIDED|95.0|-0.36|0.31|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.31|-0.36|0.882
70863591|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.17||0.084|TWO_SIDED|95.0|-0.63|0.04|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.63|0.084
70863592|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.17||0.405|TWO_SIDED|95.0|-0.47|0.19|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.47|0.405
70863593|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-0.94|-0.3|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.30|-0.94|<0.001
70863594|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.09|-0.44|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.44|-1.09|<0.001
70863595|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.3|-0.64|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.64|-1.30|<0.001
70863596|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.32|-0.67|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.67|-1.32|<0.001
70863597|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.02|-0.3|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.30|-1.02|<0.001
70863598|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-0.99|-0.27|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.27|-0.99|<0.001
70863599|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.19|-0.48|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.48|-1.19|<0.001
70863600|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.29|-0.57|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.57|-1.29|<0.001
71137373|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|-9.0||||0.518|TWO_SIDED|95.0|-36.0|17.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||17.9|-36.0|0.518
71137374|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|12.5||||0.428|TWO_SIDED|95.0|-18.6|43.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||43.6|-18.6|0.428
71137375|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|3.9||||0.757|TWO_SIDED|95.0|-20.7|28.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||28.4|-20.7|0.757
71137376|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|4.6||||0.745|TWO_SIDED|95.0|-23.2|32.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||32.4|-23.2|0.745
71137377|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|-5.8||||1|TWO_SIDED|95.0|-34.6|23.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||23.0|-34.6|1.000
71137378|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|3.6||||0.773|TWO_SIDED|95.0|-20.6|27.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||27.7|-20.6|0.773
71137379|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|-2.8||||0.838|TWO_SIDED|95.0|-29.4|23.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||23.8|-29.4|0.838
71137380|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|-12.9||||0.497|TWO_SIDED|95.0|-40.0|14.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||14.1|-40.0|0.497
71137381|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|10.5||||0.404|TWO_SIDED|95.0|-14.0|34.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||34.9|-14.0|0.404
71137382|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|-2.8||||0.838|TWO_SIDED|95.0|-29.4|23.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||23.8|-29.4|0.838
70863601|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.18||0.002|TWO_SIDED|95.0|-0.89|-0.2|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.20|-0.89|0.002
70863602|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.32|-0.63|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.63|-1.32|<0.001
70863603|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.39|-0.7|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.70|-1.39|<0.001
70863604|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.55|-0.86|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.86|-1.55|<0.001
71137383|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|3.6||||1|TWO_SIDED|95.0|-24.4|31.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||31.6|-24.4|1.000
71137384|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|16.4||||0.174|TWO_SIDED|95.0|-7.0|39.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||39.8|-7.0|0.174
70863605|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.18|-0.43|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.43|-1.18|<0.001
71137385|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|6.6||||0.611|TWO_SIDED|95.0|-19.1|32.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||32.3|-19.1|0.611
71137386|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||4.6|-14.6|1.000
71137387|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|-5.0||||0.488|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||4.6|-14.6|0.488
71137388|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||4.6|-14.6|1.000
71137389|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||4.6|-14.6|1.000
71137390|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|-5.0||||0.488|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||4.6|-14.6|0.488
71137391|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||4.6|-14.6|1.000
71137392|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||4.6|-14.6|1.000
71137393|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|-0.2||||1|TWO_SIDED|95.0|-13.4|13.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||13.0|-13.4|1.000
71137394|NCT02365649|141776307|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||4.6|-14.6|1.000
71137395|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-72.2|45.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||45.5|-72.2|1.000
71137396|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|-8.6||||1|TWO_SIDED|95.0|-50.2|33.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||33.1|-50.2|1.000
71137397|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|20.0||||1|TWO_SIDED|95.0|-4.8|44.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||44.8|-4.8|1.000
71137398|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|-23.3||||0.423|TWO_SIDED|95.0|-79.8|33.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||33.2|-79.8|0.423
71137399|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|-32.9||||0.25|TWO_SIDED|95.0|-74.0|8.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||8.2|-74.0|0.250
71137400|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|10.0||||1|TWO_SIDED|95.0|-8.6|28.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||28.6|-8.6|1.000
71137401|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|20.0||||1|TWO_SIDED|95.0|-4.8|44.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||44.8|-4.8|1.000
71137402|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|-8.6||||1|TWO_SIDED|95.0|-50.2|33.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||33.1|-50.2|1.000
71137403|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-72.2|45.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||45.5|-72.2|1.000
71137404|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|-46.7||||0.203|TWO_SIDED|95.0|-100.0|12.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||12.2|-100.0|0.203
71137405|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|-8.6||||1|TWO_SIDED|95.0|-50.2|33.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||33.1|-50.2|1.000
70863606|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.28|-0.53|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.53|-1.28|<0.001
70863607|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.33|-0.58|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.58|-1.33|<0.001
70863608|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.56|-0.81|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.81|-1.56|<0.001
70863609|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.02|-0.31|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.31|-1.02|<0.001
70863610|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.08|-0.37|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.37|-1.08|<0.001
70863611|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.36|-0.65|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.65|-1.36|<0.001
70863612|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.17|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.52|-0.81|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.81|-1.52|<0.001
70863613|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.29|-0.51|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.51|-1.29|<0.001
70863614|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.3|-0.51|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.51|-1.30|<0.001
70863615|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.36|-0.58|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.58|-1.36|<0.001
70863616|NCT00809354|141213034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.2|<|0.01|TWO_SIDED|95.0|-1.57|-0.79|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.79|-1.57|<0.01
70863617|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.469|TWO_SIDED|95.0|-0.08|0.17|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.08|0.469
70863618|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.06||0.387|TWO_SIDED|95.0|-0.18|0.07|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.07|-0.18|0.387
70863619|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.887|TWO_SIDED|95.0|-0.11|0.13|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.11|0.887
70863620|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.11|STANDARD_ERROR_OF_MEAN|0.06||0.084|TWO_SIDED|95.0|-0.01|0.23|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.01|0.084
70863621|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.07||0.018|TWO_SIDED|95.0|0.03|0.29|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.29|0.03|0.018
70863622|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.783|TWO_SIDED|95.0|-0.11|0.15|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.11|0.783
70863623|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.762|TWO_SIDED|95.0|-0.11|0.15|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.11|0.762
70863624|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.07||0.017|TWO_SIDED|95.0|0.03|0.29|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.29|0.03|0.017
70863625|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.06||0.207|TWO_SIDED|95.0|-0.2|0.04|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.20|0.207
70863626|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.06||0.02|TWO_SIDED|95.0|-0.27|-0.02|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.02|-0.27|0.020
70863627|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.941|TWO_SIDED|95.0|-0.13|0.12|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.13|0.941
70863628|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.494|TWO_SIDED|95.0|-0.18|0.09|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.18|0.494
70863629|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.089|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.25|0.089
71137406|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-72.2|45.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||45.5|-72.2|1.000
71137407|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|6.7||||1|TWO_SIDED|95.0|-54.7|68.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||68.0|-54.7|1.000
71137408|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|11.4||||1|TWO_SIDED|95.0|-33.8|56.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||56.6|-33.8|1.000
71137409|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|6.7||||1|TWO_SIDED|95.0|-54.7|68.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||68.0|-54.7|1.000
71137410|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||86.7|-20.0|1.000
70863630|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.467|TWO_SIDED|95.0|-0.18|0.08|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.08|-0.18|0.467
70863631|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.774|TWO_SIDED|95.0|-0.11|0.15|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.11|0.774
70863632|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.06||0.315|TWO_SIDED|95.0|-0.06|0.19|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.06|0.315
71137411|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||70.8|-100.0|1.000
71137412|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||86.7|-20.0|1.000
71137413|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||86.7|-20.0|1.000
71137414|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||70.8|-100.0|1.000
71137415|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||86.7|-20.0|1.000
71137416|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|-33.3||||1|TWO_SIDED|95.0|-100.0|42.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||42.1|-100.0|1.000
71137417|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||70.8|-100.0|1.000
71137418|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||86.7|-20.0|1.000
71137419|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-75.4|75.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||75.4|-75.4|1.000
70863633|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.088|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.25|0.088
70863634|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.084|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.25|0.084
70863635|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.066|TWO_SIDED|95.0|-0.25|0.01|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.25|0.066
70863636|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.073|TWO_SIDED|95.0|-0.25|0.01|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.25|0.073
70863637|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.682|TWO_SIDED|95.0|-0.16|0.1|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.10|-0.16|0.682
70863638|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.014|TWO_SIDED|95.0|-0.3|-0.03|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.03|-0.30|0.014
70863639|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.07||0.027|TWO_SIDED|95.0|-0.28|-0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.02|-0.28|0.027
70863640|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.871|TWO_SIDED|95.0|-0.14|0.12|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.14|0.871
71137420|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||70.8|-100.0|1.000
71137421|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||86.7|-20.0|1.000
70863641|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.07||0.301|TWO_SIDED|95.0|-0.21|0.06|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.21|0.301
70863642|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.181|TWO_SIDED|95.0|-0.23|0.04|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.23|0.181
70863643|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.013|TWO_SIDED|95.0|-0.3|-0.04|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.30|0.013
71137422|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-75.4|75.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||75.4|-75.4|1.000
70863644|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.07||0.031|TWO_SIDED|95.0|-0.28|-0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.28|0.031
71137423|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|-33.3||||1|TWO_SIDED|95.0|-86.7|20.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||20.0|-86.7|1.000
71137424|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|66.7||||1|TWO_SIDED|95.0|13.3|100.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||100.0|13.3|1.000
70863645|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.874|TWO_SIDED|95.0|-0.15|0.13|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.15|0.874
70863646|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.447|TWO_SIDED|95.0|-0.19|0.08|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.08|-0.19|0.447
70863647|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.059|TWO_SIDED|95.0|-0.27|0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.27|0.059
70863648|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.196|TWO_SIDED|95.0|-0.23|0.05|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.23|0.196
70863649|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.36|TWO_SIDED|95.0|-0.18|0.06|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.18|0.360
71137425|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|6.4||||1|TWO_SIDED|90.0|-31.2|44.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||44.0|-31.2|1.000
71137426|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|-10.3||||0.655|TWO_SIDED|95.0|-48.6|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||28.1|-48.6|0.655
71137427|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|23.1||||0.541|TWO_SIDED|95.0|0.2|46.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||46.0|0.2|0.541
71137428|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|-1.3||||1|TWO_SIDED|95.0|-37.0|34.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||34.4|-37.0|1.000
71137429|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|-29.1||||0.178|TWO_SIDED|95.0|-67.0|8.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||8.9|-67.0|0.178
71137430|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|15.4||||1|TWO_SIDED|95.0|-4.2|35.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||35.0|-4.2|1.000
71137431|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|-10.3||||1|TWO_SIDED|95.0|-54.4|33.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||33.9|-54.4|1.000
71137432|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|-10.3||||0.655|TWO_SIDED|95.0|-48.6|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||28.1|-48.6|0.655
71137433|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|-1.9||||1|TWO_SIDED|95.0|-50.1|46.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||46.3|-50.1|1.000
71137434|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|-26.9||||0.32|TWO_SIDED|95.0|-73.0|19.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||19.2|-73.0|0.320
71137435|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|-10.3||||0.655|TWO_SIDED|95.0|-48.6|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||28.1|-48.6|0.655
70863650|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.845|TWO_SIDED|95.0|-0.13|0.11|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.13|0.845
71137436|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|-1.9||||1|TWO_SIDED|95.0|-50.1|46.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||46.3|-50.1|1.000
71137437|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|-3.8||||1|TWO_SIDED|95.0|-52.2|44.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||44.5|-52.2|1.000
71137438|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|1.7||||1|TWO_SIDED|95.0|-40.6|44.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||44.0|-40.6|1.000
71137439|NCT02365649|141776308|SUPERIORITY||Risk Difference (RD)|21.2||||0.603|TWO_SIDED|95.0|-29.2|71.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||71.5|-29.2|0.603
71137440|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|15.4||||0.673|TWO_SIDED|95.0|-25.6|56.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||56.5|-25.6|0.673
71137441|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|19.6||||0.265|TWO_SIDED|95.0|-14.0|53.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||53.3|-14.0|0.265
71137442|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|12.9||||0.695|TWO_SIDED|95.0|-25.6|51.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||51.5|-25.6|0.695
71137443|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-20.6||||0.394|TWO_SIDED|95.0|-61.4|20.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||20.3|-61.4|0.394
71137444|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-3.9||||1|TWO_SIDED|95.0|-36.1|28.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||28.3|-36.1|1.000
71137445|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-10.6||||0.683|TWO_SIDED|95.0|-47.9|26.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||26.7|-47.9|0.683
71137446|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|28.7||||0.205|TWO_SIDED|95.0|-4.1|61.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||61.4|-4.1|0.205
71137447|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|14.5||||0.388|TWO_SIDED|95.0|-17.9|46.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||46.9|-17.9|0.388
71137448|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-28.8||||0.236|TWO_SIDED|95.0|-65.6|8.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||8.0|-65.6|0.236
71137449|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-9.6||||1|TWO_SIDED|95.0|-50.6|31.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||31.5|-50.6|1.000
70863651|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.076|TWO_SIDED|95.0|-0.23|0.01|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.23|0.076
70863652|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.957|TWO_SIDED|95.0|-0.12|0.12|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.12|0.957
70863653|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.404|TWO_SIDED|95.0|-0.19|0.08|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.08|-0.19|0.404
70863654|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.128|TWO_SIDED|95.0|-0.03|0.23|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.03|0.128
70863655|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.577|TWO_SIDED|95.0|-0.17|0.09|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.17|0.577
71137450|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|26.3||||0.131|TWO_SIDED|95.0|-6.3|58.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||58.9|-6.3|0.131
71137451|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-7.1||||1|TWO_SIDED|95.0|-45.6|31.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||31.5|-45.6|1.000
71137452|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|21.3||||0.411|TWO_SIDED|95.0|-19.6|62.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||62.2|-19.6|0.411
70863656|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.07||0.068|TWO_SIDED|95.0|-0.01|0.25|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.25|-0.01|0.068
70863657|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.06||0.011|TWO_SIDED|95.0|-0.28|-0.04|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.28|0.011
71137453|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|32.2||||0.067|TWO_SIDED|95.0|-0.2|64.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||64.5|-0.2|0.067
71137454|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-1.2||||1|TWO_SIDED|95.0|-39.5|37.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||37.2|-39.5|1.000
71137455|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|26.6||||0.178|TWO_SIDED|95.0|-8.8|62.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||62.0|-8.8|0.178
71137456|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-5.7||||0.72|TWO_SIDED|95.0|-23.8|12.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||12.3|-23.8|0.720
71137457|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-7.9||||0.683|TWO_SIDED|95.0|-27.2|11.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||11.5|-27.2|0.683
71137458|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|23.0||||0.215|TWO_SIDED|95.0|-12.8|58.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||58.9|-12.8|0.215
71137459|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-12.3||||0.279|TWO_SIDED|95.0|-30.4|5.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||5.8|-30.4|0.279
71137460|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-6.4||||0.716|TWO_SIDED|95.0|-28.2|15.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||15.4|-28.2|0.716
71137461|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-3.2||||1|TWO_SIDED|95.0|-27.5|21.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||21.1|-27.5|1.000
71137462|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-8.2||||0.4|TWO_SIDED|95.0|-23.5|7.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||7.1|-23.5|0.400
71137463|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|0.7||||1|TWO_SIDED|95.0|-19.6|21.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||21.0|-19.6|1.000
71137464|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|7.9||||0.62|TWO_SIDED|95.0|-22.2|38.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||38.0|-22.2|0.620
71137465|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-8.2||||0.4|TWO_SIDED|95.0|-23.5|7.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||7.1|-23.5|0.400
71137466|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-4.3||||1|TWO_SIDED|95.0|-22.7|14.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||14.2|-22.7|1.000
71137467|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|4.0||||1|TWO_SIDED|95.0|-18.7|26.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||26.6|-18.7|1.000
70863658|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.36|-0.11|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.11|-0.36|<0.001
71137468|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|5.0||||0.678|TWO_SIDED|95.0|-9.7|19.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||19.6|-9.7|0.678
71137469|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|7.9||||0.636|TWO_SIDED|95.0|-10.5|26.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||26.2|-10.5|0.636
71137470|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|21.4||||0.19|TWO_SIDED|95.0|-9.7|52.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||52.5|-9.7|0.190
70863659|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.43|-0.18|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.18|-0.43|<0.001
70863660|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.36|-0.12|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.12|-0.36|<0.001
70863661|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.07||0.043|TWO_SIDED|95.0|-0.27|0.0|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.00|-0.27|0.043
70863662|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.07||0.007|TWO_SIDED|95.0|-0.31|-0.05|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.05|-0.31|0.007
70863663|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.38|-0.12|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.12|-0.38|<0.001
71137471|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|9.0||||0.504|TWO_SIDED|95.0|-17.3|35.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||35.3|-17.3|0.504
71137472|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|1.6||||0.916|TWO_SIDED|95.0|-27.8|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||31.0|-27.8|0.916
70863664|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.36|-0.1|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.10|-0.36|<0.001
70863665|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.074|TWO_SIDED|95.0|-0.25|0.01|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.25|0.074
70863666|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.37|-0.1|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.10|-0.37|<0.001
71137473|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-31.7|31.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||31.7|-31.7|1.000
71137474|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-9.0||||0.504|TWO_SIDED|95.0|-35.3|17.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||17.3|-35.3|0.504
71137475|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-7.1||||0.635|TWO_SIDED|95.0|-36.6|22.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||22.3|-36.6|0.635
71137476|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|10.7||||0.513|TWO_SIDED|95.0|-21.1|42.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||42.5|-21.1|0.513
71137477|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|1.7||||0.898|TWO_SIDED|95.0|-24.7|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||28.1|-24.7|0.898
71137478|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-13.1||||0.379|TWO_SIDED|95.0|-41.7|15.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||15.5|-41.7|0.379
71137479|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-3.6||||0.822|TWO_SIDED|95.0|-34.5|27.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||27.4|-34.5|0.822
71137480|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|8.9||||0.508|TWO_SIDED|95.0|-17.3|35.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||35.0|-17.3|0.508
71137481|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-6.0||||0.683|TWO_SIDED|95.0|-34.3|22.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||22.4|-34.3|0.683
71137482|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|14.3||||0.49|TWO_SIDED|95.0|-16.6|45.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||45.1|-16.6|0.490
71137483|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|23.3||||0.078|TWO_SIDED|95.0|-1.9|48.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||48.5|-1.9|0.078
71137484|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|10.3||||0.466|TWO_SIDED|95.0|-17.7|38.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||38.4|-17.7|0.466
71137485|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||5.3|-17.1|1.000
71137486|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-5.9||||0.447|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||5.3|-17.1|0.447
71137487|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||5.3|-17.1|1.000
71137488|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-11.8||||1|TWO_SIDED|95.0|-27.1|3.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||3.6|-27.1|1.000
70863667|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.37|-0.1|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.10|-0.37|<0.001
70863668|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.49|-0.23|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.23|-0.49|<0.001
70863669|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.236|TWO_SIDED|95.0|-0.21|0.05|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.21|0.236
70863670|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.112|TWO_SIDED|95.0|-0.24|0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.24|0.112
70863671|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.38|-0.11|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.11|-0.38|<0.001
70863672|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.39|-0.12|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.12|-0.39|<0.001
70863673|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.059|TWO_SIDED|95.0|-0.26|0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.26|0.059
70863674|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.003|TWO_SIDED|95.0|-0.33|-0.07|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.07|-0.33|0.003
70863675|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.07||0.001|TWO_SIDED|95.0|-0.36|-0.09|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.09|-0.36|0.001
70863676|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.51|-0.24|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.24|-0.51|<0.001
71137489|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-11.8||||0.193|TWO_SIDED|95.0|-27.1|3.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||3.6|-27.1|0.193
70863677|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.055|TWO_SIDED|95.0|-0.27|0.0|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.00|-0.27|0.055
71137490|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-11.8||||0.498|TWO_SIDED|95.0|-27.1|3.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||3.6|-27.1|0.498
71137491|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||5.3|-17.1|1.000
71137492|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-5.9||||0.447|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||5.3|-17.1|0.447
71137493|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||5.3|-17.1|1.000
71137494|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||5.3|-17.1|1.000
71137495|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-5.9||||0.447|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||5.3|-17.1|0.447
71137496|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||5.3|-17.1|1.000
71137497|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||5.3|-17.1|1.000
71137498|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-1.1||||1|TWO_SIDED|95.0|-15.5|13.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||13.3|-15.5|1.000
71137499|NCT02365649|141776309|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||5.3|-17.1|1.000
71137500|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|-6.7||||1|TWO_SIDED|95.0|-57.2|43.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||43.9|-57.2|1.000
71137501|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|23.3||||0.323|TWO_SIDED|95.0|-9.2|55.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||55.8|-9.2|0.323
71137502|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|33.3||||0.516|TWO_SIDED|95.0|6.7|60.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||60.0|6.7|0.516
71137503|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|-31.7||||0.191|TWO_SIDED|95.0|-77.4|14.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||14.0|-77.4|0.191
71137504|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|-1.7||||1|TWO_SIDED|95.0|-26.0|22.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||22.6|-26.0|1.000
71137505|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-7.3|24.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||24.0|-7.3|1.000
71137506|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|33.3||||0.261|TWO_SIDED|95.0|6.7|60.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||60.0|6.7|0.261
71137507|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|23.3||||0.323|TWO_SIDED|95.0|-9.2|55.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||55.8|-9.2|0.323
71137508|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-41.8|58.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||58.5|-41.8|1.000
71137509|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|-26.7||||0.593|TWO_SIDED|95.0|-77.2|23.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||23.9|-77.2|0.593
71137510|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|23.3||||0.323|TWO_SIDED|95.0|-9.2|55.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||55.8|-9.2|0.323
71137511|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-41.8|58.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||58.5|-41.8|1.000
71137512|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|21.7||||0.6|TWO_SIDED|95.0|-23.1|66.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||66.5|-23.1|0.600
71137513|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|31.7||||0.162|TWO_SIDED|95.0|-1.9|65.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||65.2|-1.9|0.162
71137514|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|16.7||||1|TWO_SIDED|95.0|-34.1|67.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||67.4|-34.1|1.000
71137515|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|13.3||||1|TWO_SIDED|95.0|-50.5|77.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||77.2|-50.5|1.000
71137516|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||70.8|-100.0|1.000
71137517|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||86.7|-20.0|1.000
71137518|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|-40.0||||0.464|TWO_SIDED|95.0|-82.9|2.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||2.9|-82.9|0.464
71137519|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|-50.0||||0.4|TWO_SIDED|95.0|-100.0|19.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||19.3|-100.0|0.400
71137520|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|-46.7||||0.464|TWO_SIDED|95.0|-100.0|17.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||17.2|-100.0|0.464
71137521|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||70.8|-100.0|1.000
71137522|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||86.7|-20.0|1.000
71137523|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|-26.7||||1|TWO_SIDED|95.0|-95.1|41.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||41.8|-95.1|1.000
71137524|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||70.8|-100.0|1.000
71137525|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||86.7|-20.0|1.000
71137526|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-77.2|50.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||50.5|-77.2|1.000
71137527|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|16.7||||1|TWO_SIDED|95.0|-70.8|100.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||100.0|-70.8|1.000
71137528|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|66.7||||1|TWO_SIDED|95.0|13.3|100.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||100.0|13.3|1.000
71137529|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|3.3||||1|TWO_SIDED|95.0|-33.8|40.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||40.4|-33.8|1.000
71137530|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|16.7||||0.408|TWO_SIDED|95.0|-15.2|48.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||48.5|-15.2|0.408
71137531|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|33.3||||0.266|TWO_SIDED|95.0|9.5|57.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||57.2|9.5|0.266
71137532|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|-33.3||||0.121|TWO_SIDED|95.0|-66.2|-0.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||-0.5|-66.2|0.121
71137533|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|-10.0||||-10|TWO_SIDED|95.0|-34.6|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||14.6|-34.6|-10.0
71137534|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|6.7||||1|TWO_SIDED|95.0|-6.0|19.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||19.3|-6.0|1.000
71137535|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|-6.7||||1|TWO_SIDED|95.0|-45.3|31.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||31.9|-45.3|1.000
71137536|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|16.7||||0.408|TWO_SIDED|95.0|-15.2|48.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||48.5|-15.2|0.408
71137537|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|13.3||||1|TWO_SIDED|95.0|-29.1|55.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||55.7|-29.1|1.000
71137538|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|-26.7||||0.241|TWO_SIDED|95.0|-65.3|11.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||11.9|-65.3|0.241
71137539|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|16.7||||0.408|TWO_SIDED|95.0|-15.2|48.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||48.5|-15.2|0.408
71137540|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|13.3||||1|TWO_SIDED|95.0|-29.1|55.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||55.7|-29.1|1.000
71137541|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|-3.3||||1|TWO_SIDED|95.0|-43.3|36.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||36.6|-43.3|1.000
71137542|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|30.0||||0.217|TWO_SIDED|95.0|-2.9|62.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||62.9|-2.9|0.217
71137543|NCT02365649|141776310|SUPERIORITY||Risk Difference (RD)|26.7||||0.603|TWO_SIDED|95.0|-16.5|69.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||69.9|-16.5|0.603
71137544|NCT02365649|141776311|SUPERIORITY||Risk Difference (RD)|12.5||||0.686|TWO_SIDED|95.0|-27.6|52.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||52.6|-27.6|0.686
71137545|NCT02365649|141776311|SUPERIORITY||Risk Difference (RD)|18.8||||0.257|TWO_SIDED|95.0|-12.8|50.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||50.3|-12.8|0.257
71137546|NCT02365649|141776311|SUPERIORITY||Risk Difference (RD)|-10.0||||0.709|TWO_SIDED|95.0|-47.4|27.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||27.4|-47.4|0.709
71137547|NCT02365649|141776311|SUPERIORITY||Risk Difference (RD)|3.7||||1|TWO_SIDED|95.0|-16.6|24.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||24.1|-16.6|1.000
71137548|NCT02365649|141776311|SUPERIORITY||Risk Difference (RD)|8.5||||0.428|TWO_SIDED|95.0|-6.1|23.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||23.0|-6.1|0.428
71137549|NCT02365649|141776311|SUPERIORITY||Risk Difference (RD)|6.8||||0.639|TWO_SIDED|95.0|-9.3|22.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||22.9|-9.3|0.639
71137550|NCT02365649|141776311|SUPERIORITY||Risk Difference (RD)|8.5||||0.583|TWO_SIDED|95.0|-22.2|39.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||39.2|-22.2|0.583
70863678|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.07||0.038|TWO_SIDED|95.0|-0.28|-0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.28|0.038
71137551|NCT02365649|141776311|SUPERIORITY||Risk Difference (RD)|17.3||||0.171|TWO_SIDED|95.0|-7.2|41.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||41.9|-7.2|0.171
71137552|NCT02365649|141776311|SUPERIORITY||Risk Difference (RD)|2.5||||0.859|TWO_SIDED|95.0|-24.8|29.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||29.7|-24.8|0.859
71137553|NCT02365649|141776311|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||4.6|-14.6|1.000
70863679|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.07||0.007|TWO_SIDED|95.0|-0.33|-0.05|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.05|-0.33|0.007
70863680|NCT00809354|141213035|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.42|-0.14|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.14|-0.42|<0.001
70863681|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.469|TWO_SIDED|95.0|-0.08|0.17|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.08|0.469
70863682|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.06||0.387|TWO_SIDED|95.0|-0.18|0.07|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.07|-0.18|0.387
70863683|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.887|TWO_SIDED|95.0|-0.11|0.13|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.11|0.887
70863684|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.11|STANDARD_ERROR_OF_MEAN|0.06||0.084|TWO_SIDED|95.0|-0.01|0.23|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.01|0.084
70863685|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.07||0.018|TWO_SIDED|95.0|0.03|0.29|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.29|0.03|0.018
70863686|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.783|TWO_SIDED|95.0|-0.11|0.15|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.11|0.783
70863687|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.762|TWO_SIDED|95.0|-0.11|0.15|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.11|0.762
70863688|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.07||0.017|TWO_SIDED|95.0|0.03|0.29|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.29|0.03|0.017
71137554|NCT02365649|141776311|SUPERIORITY||Risk Difference (RD)|-0.2||||1|TWO_SIDED|95.0|-13.4|13.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||13.0|-13.4|1.000
70863689|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.091|TWO_SIDED|95.0|-0.23|0.02|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.23|0.091
70863690|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.06||0.009|TWO_SIDED|95.0|-0.29|-0.04|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.29|0.009
70863691|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.835|TWO_SIDED|95.0|-0.13|0.11|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.13|0.835
71137555|NCT02365649|141776311|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||4.6|-14.6|1.000
71137556|NCT02365649|141776312|SUPERIORITY||Risk Difference (RD)|2.5||||1|TWO_SIDED|95.0|-23.9|28.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||28.9|-23.9|1.000
71137557|NCT02365649|141776312|SUPERIORITY||Risk Difference (RD)|21.3||||0.204|TWO_SIDED|95.0|-5.0|47.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||47.5|-5.0|0.204
70863692|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.06||0.463|TWO_SIDED|95.0|-0.08|0.17|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.08|0.463
70863693|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.713|TWO_SIDED|95.0|-0.16|0.11|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.16|0.713
71137558|NCT02365649|141776312|SUPERIORITY||Risk Difference (RD)|-10.0||||0.54|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||3.1|-23.1|0.540
71137559|NCT02365649|141776312|SUPERIORITY||Risk Difference (RD)|-6.3||||1|TWO_SIDED|95.0|-14.6|2.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||2.1|-14.6|1.000
71137560|NCT02365649|141776312|SUPERIORITY||Risk Difference (RD)|2.6||||1|TWO_SIDED|95.0|-10.1|15.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||15.3|-10.1|1.000
70863694|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.267|TWO_SIDED|95.0|-0.21|0.06|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.21|0.267
70863695|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.552|TWO_SIDED|95.0|-0.17|0.09|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.17|0.552
70863696|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.07||0.885|TWO_SIDED|95.0|-0.12|0.14|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.14|-0.12|0.885
70863697|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.47|TWO_SIDED|95.0|-0.26|0.0|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.00|-0.26|0.47
70863698|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.056|TWO_SIDED|95.0|-0.26|0.0|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.00|-0.26|0.056
70863699|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.117|TWO_SIDED|95.0|-0.24|0.03|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.24|0.117
70863700|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.106|TWO_SIDED|95.0|-0.24|0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.24|0.106
70863701|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.673|TWO_SIDED|95.0|-0.16|0.1|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.10|-0.16|0.673
70863702|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.089|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.25|0.089
70863703|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.065|TWO_SIDED|95.0|-0.26|0.01|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.26|0.065
70863704|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.567|TWO_SIDED|95.0|-0.17|0.09|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.17|0.567
70863705|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.135|TWO_SIDED|95.0|-0.24|0.03|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.24|0.135
70863706|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.094|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.25|0.094
70863707|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.055|TWO_SIDED|95.0|-0.27|0.0|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.00|-0.27|0.055
70863708|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.087|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.25|0.087
71137561|NCT02365649|141776312|SUPERIORITY||Risk Difference (RD)|2.4||||1|TWO_SIDED|95.0|-11.8|16.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||16.7|-11.8|1.000
70863709|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.542|TWO_SIDED|95.0|-0.18|0.1|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.10|-0.18|0.542
70863710|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.643|TWO_SIDED|95.0|-0.17|0.11|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.17|0.643
70863711|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.07||0.301|TWO_SIDED|95.0|-0.21|0.07|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.07|-0.21|0.301
70863712|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.237|TWO_SIDED|95.0|-0.22|0.05|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.22|0.237
70863713|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.36|TWO_SIDED|95.0|-0.18|0.06|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.18|0.360
70863714|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.854|TWO_SIDED|95.0|-0.13|0.11|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.13|0.854
70863715|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.076|TWO_SIDED|95.0|-0.23|0.01|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.23|0.076
70863716|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.957|TWO_SIDED|95.0|-0.12|0.12|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.12|0.957
71137562|NCT02365649|141776312|SUPERIORITY||Risk Difference (RD)|0.9||||1|TWO_SIDED|95.0|-15.0|16.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||16.8|-15.0|1.000
70863717|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.404|TWO_SIDED|95.0|-0.19|0.08|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.08|-0.19|0.404
70863718|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.128|TWO_SIDED|95.0|-0.03|0.23|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.03|0.128
71137563|NCT02365649|141776312|SUPERIORITY||Risk Difference (RD)|14.4||||0.135|TWO_SIDED|95.0|-2.5|31.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||31.4|-2.5|0.135
71137564|NCT02365649|141776312|SUPERIORITY||Risk Difference (RD)|4.3||||0.623|TWO_SIDED|95.0|-11.9|20.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||20.4|-11.9|0.623
70863719|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.577|TWO_SIDED|95.0|-0.17|0.09|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.17|0.577
70863720|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.07||0.068|TWO_SIDED|95.0|-0.01|0.25|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.25|-0.01|0.068
70863721|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.06||0.016|TWO_SIDED|95.0|-0.27|-0.03|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.03|-0.27|0.016
70863722|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.38|-0.13|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.13|-0.38|<0.001
70863723|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.44|-0.19|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.19|-0.44|<0.001
70863724|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.39|-0.15|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.15|-0.39|<0.001
71137565|NCT02365649|141776312|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||3.1|-23.1|1.000
71137566|NCT02365649|141776312|SUPERIORITY||Risk Difference (RD)|-0.5||||1|TWO_SIDED|95.0|-18.7|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||17.7|-18.7|1.000
70863725|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.07||0.037|TWO_SIDED|95.0|-0.27|-0.01|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.27|0.037
70863726|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.015|TWO_SIDED|95.0|-0.3|-0.03|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.03|-0.30|0.015
70863727|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||0.07|-0.22||||0.001|TWO_SIDED|95.0|-0.35|-0.08|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.08|-0.35|0.001
71137567|NCT02365649|141776312|SUPERIORITY||Risk Difference (RD)|-10.0||||0.501|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||3.1|-23.1|0.501
70863728|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED|95.0|-0.34|-0.07|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.07|-0.34|0.002
71137568|NCT02365649|141776313|SUPERIORITY||Risk Difference (RD)|2.5||||1|TWO_SIDED|95.0|-23.9|28.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||28.9|-23.9|1.000
71137569|NCT02365649|141776313|SUPERIORITY||Risk Difference (RD)|21.3||||0.204|TWO_SIDED|95.0|-5.0|47.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||47.5|-5.0|0.204
70863729|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.07||0.042|TWO_SIDED|95.0|-0.27|0.0|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.00|-0.27|0.042
70863730|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.4|-0.14|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.14|-0.40|<0.001
70863731|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.4|-0.13|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.13|-0.40|<0.001
70863732|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.5|-0.24|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.24|-0.50|<0.001
70863733|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.182|TWO_SIDED|95.0|-0.22|0.04|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.22|0.182
70863734|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.08|TWO_SIDED|95.0|-0.25|0.01|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.25|0.080
70863735|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED|95.0|-0.34|-0.07|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.07|-0.34|0.002
71137570|NCT02365649|141776313|SUPERIORITY||Risk Difference (RD)|-10.0||||0.54|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||3.1|-23.1|0.540
70863736|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.37|-0.11|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.11|-0.37|<0.001
71137571|NCT02365649|141776313|SUPERIORITY||Risk Difference (RD)|-3.1||||1|TWO_SIDED|95.0|-9.2|2.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||2.9|-9.2|1.000
70863737|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.016|TWO_SIDED|95.0|-0.3|-0.03|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.03|-0.30|0.016
71137572|NCT02365649|141776313|SUPERIORITY||Risk Difference (RD)|5.7||||0.614|TWO_SIDED|95.0|-5.6|17.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||17.0|-5.6|0.614
71137573|NCT02365649|141776313|SUPERIORITY||Risk Difference (RD)|1.2||||1|TWO_SIDED|95.0|-9.1|11.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||11.5|-9.1|1.000
71137574|NCT02365649|141776313|SUPERIORITY||Risk Difference (RD)|0.9||||1|TWO_SIDED|95.0|-15.0|16.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||16.8|-15.0|1.000
71137575|NCT02365649|141776313|SUPERIORITY||Risk Difference (RD)|14.4||||0.135|TWO_SIDED|95.0|-2.5|31.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||31.4|-2.5|0.135
70863738|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.4|-0.13|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.13|-0.40|<0.001
70863739|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.42|-0.15|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.15|-0.42|<0.001
70863740|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.53|-0.27|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.27|-0.53|<0.001
70863741|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.07||0.032|TWO_SIDED|95.0|-0.29|-0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.29|0.032
70863742|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.07||0.006|TWO_SIDED|95.0|-0.33|-0.06|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.06|-0.33|0.006
70863743|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.07||0.009|TWO_SIDED|95.0|-0.32|-0.05|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.05|-0.32|0.009
70863744|NCT00809354|141213036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.41|-0.13|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.13|-0.41|<0.001
70863745|NCT00100178|141213080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47|||||||ANCOVA|||"The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the AUC mean and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis."||||0.47
70863746|NCT02477839|141213087|OTHER||Mean Difference (Final Values)|0.97|||||TWO_SIDED|95.0|0.83|1.14|||ANCOVA|||Difference ratio in LS Mean was calculated as the exp \[LSMLCM-LSMplacebo\].||1.14|0.83|
70863747|NCT02477839|141213087|OTHER||Percent reduction|3.19|||=|0.6895|TWO_SIDED|95.0|-13.59|17.5|||ANCOVA|||Percent reduction over placebo was estimated as 100 x (1-exp \[LSMLCM-LSMPBO\]).||17.50|-13.59|=0.6895
70863748|NCT01439568|141213111|SUPERIORITY||Hazard Ratio (HR)|1.0608||||0.8072|TWO_SIDED|95.0|0.6598|1.7055|||Logrank Test|||||1.7055|0.6598|0.8072
70863749|NCT02607930|141213134|NON_INFERIORITY|A sample of approximately 600 participants randomized 1:1 achieves at least 95% power using a non-inferiority margin of 12% assuming a response rate in both groups of 91% (Reference Genvoya studies) and a one-sided alpha level of 0.025.|Difference in Percentages|-0.6|||||TWO_SIDED|95.002|-4.8|3.6|||||Differences in percentages of participants between groups and their 95.002% CIs were calculated based on Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||3.6|-4.8|
70863750|NCT02607930|141213134|SUPERIORITY|||||||0.78|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.78
70863751|NCT02607930|141213135|OTHER||Difference in Percentages|-1.9|||||TWO_SIDED|95.0|-6.9|3.1|||||Differences in percentages of participants between groups and their 95% CIs were calculated based on Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||3.1|-6.9|
70863752|NCT02607930|141213135|OTHER|||||||0.45|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.45
71137576|NCT02365649|141776313|SUPERIORITY||Risk Difference (RD)|-1.0||||1|TWO_SIDED|95.0|-14.1|12.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||12.1|-14.1|1.000
71137577|NCT02365649|141776313|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||4.6|-14.6|1.000
70863753|NCT02607930|141213136|OTHER||Difference in Percentages|-2.6|||||TWO_SIDED|95.0|-8.5|3.4|||||Differences in percentages of participants between groups and their 95% CIs were calculated based on MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||3.4|-8.5|
70863754|NCT02607930|141213136|OTHER|||||||0.39|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.39
70863755|NCT02607930|141213137|OTHER||Difference in Percentages|0.4|||||TWO_SIDED|95.0|-4.8|5.6|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||5.6|-4.8|
70863756|NCT02607930|141213137|OTHER|||||||0.87|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.87
70863757|NCT02607930|141213138|OTHER||Difference in Percentages|-1.2|||||TWO_SIDED|95.0|-6.9|4.6|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||4.6|-6.9|
70863758|NCT02607930|141213138|OTHER|||||||0.69|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.69
70863759|NCT02607930|141213139|OTHER||Difference in Percentages|-4.2|||||TWO_SIDED|95.0|-10.5|2.1|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||2.1|-10.5|
70863760|NCT02607930|141213139|OTHER|||||||0.19|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.19
71137578|NCT02365649|141776313|SUPERIORITY||Risk Difference (RD)|4.5||||1|TWO_SIDED|95.0|-11.3|20.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||20.3|-11.3|1.000
70863761|NCT02607930|141213140|OTHER||Difference in LSM|-0.03||||0.48|TWO_SIDED|95.0|-0.12|0.06|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in least-squares mean (LSM), and its 95% confidence interval (CI) were adjusted by baseline HIV-1 RNA stratum and region stratum.|||0.06|-0.12|0.48
70863762|NCT02607930|141213141|OTHER||Difference in LSM|0.0||||0.99|TWO_SIDED|95.0|-0.09|0.09|||ANOVA||Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.|||0.09|-0.09|0.99
70863763|NCT02607930|141213142|OTHER||Difference in LSM|0.01||||0.88|TWO_SIDED|95.0|-0.08|0.1|||ANOVA||Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.|||0.10|-0.08|0.88
70863764|NCT02607930|141213143|OTHER||Difference in LSM|6.0||||0.69|TWO_SIDED|95.0|-24.0|36.0|||ANOVA|P-value was adjusted by the baseline HIV-1 RNA and region stratum.|Difference in LSM, and its 95% CI were adjusted by the baseline HIV-1 RNA and region stratum.|||36|-24|0.69
70863765|NCT02607930|141213144|OTHER||Difference in LSM|-1.0||||0.94|TWO_SIDED|95.0|-39.0|36.0|||ANOVA|P-value was adjusted by the baseline HIV-1 RNA and region stratum.|Difference in LSM, and its 95% CI were adjusted by the baseline HIV-1 RNA and region stratum.|||36|-39|0.94
70863766|NCT02607930|141213145|OTHER||Difference in LSM|-20.0||||0.3|TWO_SIDED|95.0|-59.0|18.0|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.|||18|-59|0.30
70863767|NCT02607930|141213146|OTHER||Difference in LSM|0.346||||0.092|TWO_SIDED|95.0|-0.057|0.748|||ANOVA|||||0.748|-0.057|0.092
70863768|NCT02607930|141213147|OTHER||Difference in LSM|0.135||||0.59|TWO_SIDED|95.0|-0.356|0.625|||ANOVA|||||0.625|-0.356|0.59
70863769|NCT02607930|141213148|OTHER||Difference in LSM|0.271||||0.39|TWO_SIDED|95.0|-0.351|0.893|||ANOVA|||||0.893|-0.351|0.39
70863770|NCT02607930|141213149|OTHER||Difference in LSM|-0.221||||0.41|TWO_SIDED|95.0|-0.741|0.3|||ANOVA|||||0.300|-0.741|0.41
70863771|NCT02607930|141213150|OTHER||Difference in LSM|-0.485||||0.14|TWO_SIDED|95.0|-1.126|0.155|||ANOVA|||||0.155|-1.126|0.14
70863772|NCT02607930|141213151|OTHER||Difference in LSM|-0.406||||0.26|TWO_SIDED|95.0|-1.119|0.307|||ANOVA|||||0.307|-1.119|0.26
70863773|NCT03198078|141213158|SUPERIORITY||LS mean difference|-5.33||||0.0136|TWO_SIDED|95.0|-9.55|-1.1||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||||-1.10|-9.55|0.0136
71137579|NCT02365649|141776313|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||4.6|-14.6|1.000
70863774|NCT03198078|141213158|SUPERIORITY||LS mean difference|-6.53||||0.0032|TWO_SIDED|95.0|-10.8|-2.21||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||||-2.21|-10.8|0.0032
70863775|NCT03198078|141213159|SUPERIORITY||LS mean difference|-1.44||||0.0205|TWO_SIDED|95.0|-2.65|-0.22||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||Change From Baseline to Week 6 in PANSS Positive Sub-scale Score||-0.22|-2.65|0.0205
70863776|NCT03198078|141213159|SUPERIORITY||LS mean difference|-2.15||||0.0008|TWO_SIDED|95.0|-3.4|-0.91||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||Change From Baseline to Week 6 in PANSS Positive Sub-scale Score||-0.91|-3.40|0.0008
70863777|NCT03198078|141213159|SUPERIORITY||LS mean difference|-0.88||||0.136|TWO_SIDED|95.0|-2.04|0.28||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||Change From Baseline to Week 6 in PANSS Negative Sub-scale Score||0.28|-2.04|0.1360
70863778|NCT03198078|141213159|SUPERIORITY||LS mean difference|-0.95||||0.1158|TWO_SIDED|95.0|-2.14|0.24||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||Change From Baseline to Week 6 in PANSS Negative Sub-scale Score||0.24|-2.14|0.1158
70863779|NCT03198078|141213160|SUPERIORITY||Ratio of Response Rate|1.55||||0.0111|TWO_SIDED|95.0|1.09|2.2|||Cochran-Mantel-Haenszel|P-value was analyzed by Cochran-Mantel-Haenszel (CMH) general association test controlling for (pooled) centers.||||2.20|1.09|0.0111
70863780|NCT03198078|141213160|SUPERIORITY||Ratio of Response Rate|1.51||||0.0224|TWO_SIDED|95.0|1.06|2.16|||Cochran-Mantel-Haenszel|P-value was analyzed by CMH general association test controlling for (pooled) centers.||||2.16|1.06|0.0224
70863781|NCT03198078|141213161|SUPERIORITY||Ratio of Remission Rate|1.18||||0.4415|TWO_SIDED|95.0|0.77|1.81|||Cochran-Mantel-Haenszel|P-value was analyzed by CMH general association test controlling for (pooled) centers.||||1.81|0.77|0.4415
71137580|NCT02365649|141776314|SUPERIORITY||Risk Difference (RD)|15.0||||0.669|TWO_SIDED|95.0|-21.9|51.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||51.9|-21.9|0.669
70863782|NCT03198078|141213161|SUPERIORITY||Ratio of Remission Rate|1.48||||0.0472|TWO_SIDED|95.0|1.01|2.16|||Cochran-Mantel-Haenszel|P-value was analyzed by CMH general association test controlling for (pooled) centers.||||2.16|1.01|0.0472
70863783|NCT03198078|141213162|SUPERIORITY||LS mean difference|2.48||||0.0854|TWO_SIDED|95.0|-0.35|5.31||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||||5.31|-0.35|0.0854
71137581|NCT02365649|141776314|SUPERIORITY||Risk Difference (RD)|15.0||||0.343|TWO_SIDED|95.0|-15.2|45.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||45.2|-15.2|0.343
71137582|NCT02365649|141776314|SUPERIORITY||Risk Difference (RD)|-20.0||||0.442|TWO_SIDED|95.0|-57.2|17.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||17.2|-57.2|0.442
70863784|NCT03198078|141213162|SUPERIORITY||LS mean difference|3.99||||0.0072|TWO_SIDED|95.0|1.09|6.88||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||||6.88|1.09|0.0072
71137583|NCT02365649|141776314|SUPERIORITY||Risk Difference (RD)|4.4||||1|TWO_SIDED|95.0|-23.4|32.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||32.2|-23.4|1.000
71137584|NCT02365649|141776314|SUPERIORITY||Risk Difference (RD)|5.0||||0.601|TWO_SIDED|95.0|-13.6|23.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||23.5|-13.6|0.601
71137585|NCT02365649|141776314|SUPERIORITY||Risk Difference (RD)|1.8||||1|TWO_SIDED|95.0|-18.2|21.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||21.7|-18.2|1.000
71137586|NCT02365649|141776314|SUPERIORITY||Risk Difference (RD)|16.5||||0.301|TWO_SIDED|95.0|-14.5|47.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||47.5|-14.5|0.301
71137587|NCT02365649|141776314|SUPERIORITY||Risk Difference (RD)|14.5||||0.256|TWO_SIDED|95.0|-10.3|39.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||39.4|-10.3|0.256
71137588|NCT02365649|141776314|SUPERIORITY||Risk Difference (RD)|1.5||||0.917|TWO_SIDED|95.0|-26.5|29.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||29.5|-26.5|0.917
71137589|NCT02365649|141776314|SUPERIORITY||Risk Difference (RD)|-20.2||||1|TWO_SIDED|95.0|-37.5|-2.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||-2.5|-37.5|1.000
71137590|NCT02365649|141776314|SUPERIORITY||Risk Difference (RD)|-5.7||||0.697|TWO_SIDED|95.0|-28.8|17.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||17.3|-28.8|0.697
71137591|NCT02365649|141776314|SUPERIORITY||Risk Difference (RD)|-20.0||||0.126|TWO_SIDED|95.0|-37.5|-2.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||-2.5|-37.5|0.126
71137592|NCT02365649|141776315|SUPERIORITY||Risk Difference (RD)|10.0||||0.691|TWO_SIDED|95.0|-30.8|50.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||50.8|-30.8|0.691
71137593|NCT02365649|141776315|SUPERIORITY||Risk Difference (RD)|28.8||||0.086|TWO_SIDED|95.0|-2.5|60.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||60.0|-2.5|0.086
71137594|NCT02365649|141776315|SUPERIORITY||Risk Difference (RD)|-10.0||||0.702|TWO_SIDED|95.0|-45.6|25.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||25.6|-45.6|0.702
70863785|NCT03198078|141213163|SUPERIORITY||LS mean difference|-0.11||||0.3589|TWO_SIDED|95.0|-0.36|0.13||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||||0.13|-0.36|0.3589
71137595|NCT02365649|141776315|SUPERIORITY||Risk Difference (RD)|-12.5||||0.557|TWO_SIDED|95.0|-24.0|-1.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||-1.0|-24.0|0.557
71137596|NCT02365649|141776315|SUPERIORITY||Risk Difference (RD)|-0.7||||1|TWO_SIDED|95.0|-16.5|15.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||15.0|-16.5|1.000
71137597|NCT02365649|141776315|SUPERIORITY||Risk Difference (RD)|4.9||||0.707|TWO_SIDED|95.0|-14.4|24.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||24.2|-14.4|0.707
71137598|NCT02365649|141776315|SUPERIORITY||Risk Difference (RD)|0.4||||1|TWO_SIDED|95.0|-27.9|28.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||28.8|-27.9|1.000
71137599|NCT02365649|141776315|SUPERIORITY||Risk Difference (RD)|16.7||||0.175|TWO_SIDED|95.0|-7.2|40.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||40.6|-7.2|0.175
71137600|NCT02365649|141776315|SUPERIORITY||Risk Difference (RD)|8.7||||0.517|TWO_SIDED|95.0|-18.0|35.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||35.4|-18.0|0.517
70863786|NCT03198078|141213163|SUPERIORITY||LS mean difference|-0.2||||0.1118|TWO_SIDED|95.0|-0.45|0.05||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||||0.05|-0.45|0.1118
71137601|NCT02365649|141776315|SUPERIORITY||Risk Difference (RD)|-15.0||||1|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||0.6|-30.6|1.000
71137602|NCT02365649|141776315|SUPERIORITY||Risk Difference (RD)|-5.5||||0.663|TWO_SIDED|95.0|-25.5|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||14.6|-25.5|0.663
71137603|NCT02365649|141776315|SUPERIORITY||Risk Difference (RD)|-15.0||||0.251|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||0.6|-30.6|0.251
71137604|NCT02365649|141776316|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-41.0|41.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||41.0|-41.0|1.000
71137605|NCT02365649|141776316|SUPERIORITY||Risk Difference (RD)|18.8||||0.257|TWO_SIDED|95.0|-12.8|50.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||50.3|-12.8|0.257
71137606|NCT02365649|141776316|SUPERIORITY||Risk Difference (RD)|-20.0||||0.44|TWO_SIDED|95.0|-55.9|15.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||15.9|-55.9|0.440
71137607|NCT02365649|141776316|SUPERIORITY||Risk Difference (RD)|-2.5||||1|TWO_SIDED|95.0|-24.3|19.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||19.3|-24.3|1.000
71137608|NCT02365649|141776316|SUPERIORITY||Risk Difference (RD)|-0.7||||1|TWO_SIDED|95.0|-16.5|15.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||15.0|-16.5|1.000
70863787|NCT03198078|141213164|SUPERIORITY||Mean Difference (Final Values)|-0.29||||0.0287|TWO_SIDED|95.0|-0.56|-0.03|||Cochran-Mantel-Haenszel|P-value was analyzed by CMH row mean scores differ test controlling for study center.||||-0.03|-0.56|0.0287
70863788|NCT03198078|141213164|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.0184|TWO_SIDED|95.0|-0.62|-0.06|||Cochran-Mantel-Haenszel|P-value was analyzed by CMH row mean scores differ test controlling for study center.||||-0.06|-0.62|0.0184
71137609|NCT02365649|141776316|SUPERIORITY||Risk Difference (RD)|-20.0||||0.44|TWO_SIDED|95.0|-55.9|15.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||15.9|-55.9|0.440
71137610|NCT02365649|141776316|SUPERIORITY||Risk Difference (RD)|1.3||||1|TWO_SIDED|95.0|-28.7|31.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||31.4|-28.7|1.000
71137611|NCT02365649|141776316|SUPERIORITY||Risk Difference (RD)|10.5||||0.404|TWO_SIDED|95.0|-14.0|34.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||34.9|-14.0|0.404
71137612|NCT02365649|141776316|SUPERIORITY||Risk Difference (RD)|2.5||||0.859|TWO_SIDED|95.0|-24.8|29.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||29.7|-24.8|0.859
71137613|NCT02365649|141776316|SUPERIORITY||Risk Difference (RD)|-15.0||||1|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||0.6|-30.6|1.000
71137614|NCT02365649|141776316|SUPERIORITY||Risk Difference (RD)|-5.5||||0.663|TWO_SIDED|95.0|-25.5|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||14.6|-25.5|0.663
71137615|NCT02365649|141776316|SUPERIORITY||Risk Difference (RD)|-15.0||||0.251|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||0.6|-30.6|0.251
71137616|NCT02365649|141776317|SUPERIORITY||Risk Difference (RD)|10.0||||0.606|TWO_SIDED|95.0|-23.8|43.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||43.8|-23.8|0.606
71137617|NCT02365649|141776317|SUPERIORITY||Risk Difference (RD)|35.0||||0.034|TWO_SIDED|95.0|5.9|64.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significant at the 0.5 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||64.1|5.9|0.034
71137618|NCT02365649|141776317|SUPERIORITY||Risk Difference (RD)|-15.0||||0.532|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||0.6|-30.6|0.532
70863789|NCT03198078|141213175|SUPERIORITY||LS mean difference|0.07|||||TWO_SIDED|95.0|-0.24|0.39|||||LS mean difference was analyzed by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|||0.39|-0.24|
70863790|NCT03198078|141213175|SUPERIORITY||LS mean difference|0.18|||||TWO_SIDED|95.0|-0.14|0.51|||||LS mean difference was analyzed by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|||0.51|-0.14|
70863791|NCT03198078|141213176|SUPERIORITY||LS mean difference|-0.06|||||TWO_SIDED|95.0|-0.3|0.18|||||LS mean difference was analyzed by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|||0.18|-0.30|
71137619|NCT02365649|141776317|SUPERIORITY||Risk Difference (RD)|0.6||||1|TWO_SIDED|95.0|-20.5|21.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||21.8|-20.5|1.000
71137620|NCT02365649|141776317|SUPERIORITY||Risk Difference (RD)|-0.6||||1|TWO_SIDED|95.0|-14.4|13.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||13.3|-14.4|1.000
71137621|NCT02365649|141776317|SUPERIORITY||Risk Difference (RD)|-0.7||||1|TWO_SIDED|95.0|-16.0|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||14.6|-16.0|1.000
71137622|NCT02365649|141776317|SUPERIORITY||Risk Difference (RD)|12.1||||0.35|TWO_SIDED|95.0|-11.7|35.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||35.8|-11.7|0.350
71137623|NCT02365649|141776317|SUPERIORITY||Risk Difference (RD)|21.7||||0.034|TWO_SIDED|95.0|2.0|41.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significant at the 0.5 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||41.3|2.0|0.034
70863792|NCT03198078|141213176|SUPERIORITY||LS mean difference|0.11|||||TWO_SIDED|95.0|-0.13|0.36|||||LS mean difference was analyzed by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|||0.36|-0.13|
70863793|NCT03198078|141213177|SUPERIORITY||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.08|0.09|||||LS mean difference was analyzed by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|||0.09|-0.08|
70863794|NCT03198078|141213177|SUPERIORITY||LS mean difference|0.05|||||TWO_SIDED|95.0|-0.04|0.14|||||LS mean difference was analyzed by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|||0.14|-0.04|
70863795|NCT03711266|141213180|OTHER||Mean Difference (Final Values)|31.4|||<|0.001|TWO_SIDED|95.0|18.5|44.3|||t-test, 2 sided|||Thirty patients were included in the final analysis. The analysis strategy was intent-to-treat, and multiple imputation was used to impute missing follow-up data. We included auxiliary variables that were correlated with the missing variables at r \> 0.4 (Enders, 2010).||44.3|18.5|<.001
70863796|NCT00057876|141213201|SUPERIORITY_OR_OTHER_LEGACY|||||||0.017|ONE_SIDED|95.0|||||Log Rank|||Log rank test is conducted for OS to see whether the two treatment arms are different in their overall survival probabilities.||||0.017
70863797|NCT00057876|141213202|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|ONE_SIDED|95.0|||||Log Rank|||||||0.25
70863798|NCT00057876|141213203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99|||||||Fisher Exact|||Compare objective response rate (CR+PR) between two treatment groups||||0.99
70863799|NCT02927262|141213228|SUPERIORITY||Hazard Ratio (HR)|0.738||||0.163|TWO_SIDED|95.0|0.407|1.336|||Log Rank||HR \& 95% CI are based on CHM. Assuming proportional hazards, HR \< 1 indicates a reduction in hazard rate in favor of gilteritinib arm. Stratification factors:age, geographic region, presence of MRD at screening, use of FLT3 inhibiting agents per IRT.|||1.336|0.407|0.163
70863800|NCT02927262|141213229|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.627||95.0|0.54|2.364|||Log Rank||HR \& 95%CI are based on CHM. Assuming proportional hazards, HR \< 1 indicates a reduction in hazard rate in favor of gilteritinib arm. Stratification factors: age, geographic region, presence of MRD at screening, use of FLT3 inhibiting agents per IRT.|||2.364|0.540|0.627
70863801|NCT02927262|141213230|SUPERIORITY||Hazard Ratio (HR)|0.862||||0.296|TWO_SIDED|95.0|0.51|1.455|||Log Rank||HR \& 95%CI are based on CHM. Assuming proportional hazards, HR \< 1 indicates a reduction in hazard rate in favor of gilteritinib arm. Stratification factors: age, geographic region, presence of MRD at screening, use of FLT3 inhibiting agents per IRT.|||1.455|0.510|0.296
70863802|NCT02927262|141213231|SUPERIORITY|||||||0.97||||||2-sided P-value from analysis of covariance (ANCOVA) including treatment, age group, geographic region and use of FLT3-inhibiting agents per IRT as fixed factors and baseline score as covariate.|ANCOVA|||Month 3||||0.970
70863803|NCT02927262|141213231|SUPERIORITY|||||||0.415||||||2-sided P-value from ANCOVA including treatment, age group, geographic region and use of FLT3-inhibiting agents per IRT as fixed factors and baseline score as covariate.|ANCOVA|||Month 6||||0.415
70863804|NCT02927262|141213231|SUPERIORITY|||||||0.271||||||2-sided P-value from ANCOVA including treatment, age group, geographic region and use of FLT3-inhibiting agents per IRT as fixed factors and baseline score as covariate.|ANCOVA|||Month 12||||0.271
70863805|NCT02927262|141213231|SUPERIORITY|||||||0.179||||||2-sided P-value from ANCOVA including treatment, age group, geographic region and use of FLT3-inhibiting agents per IRT as fixed factors and baseline score as covariate.|ANCOVA|||Month 24/EoT||||0.179
70863806|NCT01697358|141213239|SUPERIORITY|||||||0.036|||||||Z-test using unpooled standard deviation|||||||0.036
70863807|NCT01697358|141213240|SUPERIORITY||||||<|0.001|||||||Regression, Linear|Variables included in the linear regression model are: baseline NPRS, treatment group, and virtual center.||||||< 0.001
71137624|NCT02365649|141776317|SUPERIORITY||Risk Difference (RD)|1.2||||1|TWO_SIDED|95.0|-15.9|18.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||18.3|-15.9|1.000
71137625|NCT02365649|141776317|SUPERIORITY||Risk Difference (RD)|-15.0||||1|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||0.6|-30.6|1.000
71137626|NCT02365649|141776317|SUPERIORITY||Risk Difference (RD)|-5.5||||0.663|TWO_SIDED|95.0|-25.5|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||14.6|-25.5|0.663
71137627|NCT02365649|141776317|SUPERIORITY||Risk Difference (RD)|-15.0||||0.251|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||0.6|-30.6|0.251
71137628|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|15.0||||0.536|TWO_SIDED|95.0|-0.6|30.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||30.6|-0.6|0.536
71137629|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|15.0||||0.238|TWO_SIDED|95.0|-0.6|30.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||30.6|-0.6|0.238
71137630|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-34.3|24.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||24.3|-34.3|1.000
71137631|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|-10.0||||0.606|TWO_SIDED|95.0|-43.8|23.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||23.8|-43.8|0.606
71137632|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|-3.8||||1|TWO_SIDED|95.0|-28.5|21.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||21.0|-28.5|1.000
71137633|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|-25.0||||0.181|TWO_SIDED|95.0|-59.2|9.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||9.2|-59.2|0.181
71137634|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|25.0||||0.281|TWO_SIDED|95.0|6.0|44.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||44.0|6.0|0.281
71137635|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-28.5|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||28.5|-28.5|1.000
71137636|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|-25.0||||0.231|TWO_SIDED|95.0|-61.3|11.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||11.3|-61.3|0.231
71137637|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|37.5||||0.099|TWO_SIDED|95.0|5.8|69.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||69.2|5.8|0.099
71137638|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|31.3||||0.052|TWO_SIDED|95.0|2.2|60.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||60.3|2.2|0.052
71137639|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|-10.0||||0.709|TWO_SIDED|95.0|-47.4|27.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||27.4|-47.4|0.709
71137640|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|32.5||||0.194|TWO_SIDED|95.0|0.9|64.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||64.1|0.9|0.194
71137641|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|13.8||||0.4|TWO_SIDED|95.0|-17.7|45.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||45.2|-17.7|0.400
71137642|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-42.9|32.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||32.9|-42.9|1.000
71137643|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|16.3||||0.477|TWO_SIDED|95.0|-18.6|51.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||51.1|-18.6|0.477
71137644|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|-2.6||||0.833|TWO_SIDED|95.0|-26.4|21.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||21.3|-26.4|0.833
71137645|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|-4.6||||0.732|TWO_SIDED|95.0|-30.9|21.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||21.7|-30.9|0.732
71137646|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|19.4||||0.468|TWO_SIDED|95.0|-15.4|54.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||54.2|-15.4|0.468
71137647|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|-11.2||||0.339|TWO_SIDED|95.0|-34.1|11.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||11.7|-34.1|0.339
71137648|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|-14.5||||0.263|TWO_SIDED|95.0|-39.3|10.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||10.2|-39.3|0.263
71137649|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|11.9||||0.697|TWO_SIDED|95.0|-22.3|46.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||46.0|-22.3|0.697
71137650|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|-1.7||||0.88|TWO_SIDED|95.0|-23.2|19.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||19.9|-23.2|0.880
71137651|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|-10.7||||0.355|TWO_SIDED|95.0|-32.7|11.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||11.2|-32.7|0.355
71137652|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-27.1|37.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||37.1|-27.1|1.000
71137653|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|1.5||||0.891|TWO_SIDED|95.0|-19.6|22.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||22.6|-19.6|0.891
71137654|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|-3.3||||0.779|TWO_SIDED|95.0|-25.8|19.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||19.3|-25.8|0.779
70863808|NCT01697358|141213241|SUPERIORITY||||||<|0.001|||||||Regression, Linear|Variables included in the linear regression model are: baseline NPRS, treatment group, and virtual center.||||||< 0.001
70863809|NCT01697358|141213242|SUPERIORITY||||||<|0.001|||||||Regression, Linear|Variables included in the linear regression model are: baseline ODI, treatment group, and virtual center.||||||< 0.001
70863810|NCT01697358|141213243|SUPERIORITY||||||<|0.001|||||||Regression, Linear|Variables included in the linear regression model are: baseline PCS, treatment group, and virtual center.||||||< 0.001
71137655|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|8.1||||0.678|TWO_SIDED|95.0|-23.7|39.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||39.9|-23.7|0.678
71137656|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|4.6||||0.663|TWO_SIDED|95.0|-16.0|25.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||25.2|-16.0|0.663
70863811|NCT01697358|141213244|SUPERIORITY||||||<|0.001|||||||Z-test using unpooled standard deviation|||||||< 0.001
70863812|NCT02038452|141213245|SUPERIORITY||Mean Difference (Final Values)|-0.32|||<|0.001|TWO_SIDED|95.0|-0.48|-0.16|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||-0.16|-0.48|<0.001
70863813|NCT02038452|141213246|SUPERIORITY||Mean Difference (Final Values)|-0.35|||<|0.001|TWO_SIDED|95.0|-0.53|-0.17|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||-0.17|-0.53|<0.001
70863814|NCT02038452|141213247|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.003|TWO_SIDED|95.0|-0.43|-0.09|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||-0.09|-0.43|0.003
70863815|NCT02038452|141213248|SUPERIORITY||Mean Difference (Final Values)|-0.97||||0.005|TWO_SIDED|95.0|-1.64|-0.3|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||-0.30|-1.64|0.005
71137657|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|-8.8||||0.494|TWO_SIDED|95.0|-28.7|11.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||11.0|-28.7|0.494
71137658|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|21.9||||0.083|TWO_SIDED|95.0|7.6|36.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||36.2|7.6|0.083
71137659|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|15.0||||0.151|TWO_SIDED|95.0|-2.1|32.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||32.0|-2.1|0.151
71137660|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|0.8||||1|TWO_SIDED|95.0|-22.4|24.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||24.1|-22.4|1.000
71137661|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|0.4||||1|TWO_SIDED|95.0|-25.4|26.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||26.3|-25.4|1.000
71137662|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|-9.2||||0.417|TWO_SIDED|95.0|-31.3|12.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||12.9|-31.3|0.417
71137663|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|-20.2||||0.125|TWO_SIDED|95.0|-46.7|6.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||6.2|-46.7|0.125
71137664|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|12.9||||0.497|TWO_SIDED|95.0|-14.1|40.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||40.0|-14.1|0.497
71137665|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|-0.1||||0.993|TWO_SIDED|95.0|-24.0|23.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||23.8|-24.0|0.993
71137666|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|-18.3||||0.2|TWO_SIDED|95.0|-46.1|9.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||9.6|-46.1|0.200
71137667|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|21.4||||0.177|TWO_SIDED|95.0|-7.9|50.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||50.8|-7.9|0.177
71137668|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|22.4||||0.074|TWO_SIDED|95.0|-1.4|46.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||46.2|-1.4|0.074
71137669|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|-7.9||||0.585|TWO_SIDED|95.0|-36.1|20.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||20.3|-36.1|0.585
71137670|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|21.4||||0.177|TWO_SIDED|95.0|-7.9|50.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||50.8|-7.9|0.177
71137671|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|12.1||||0.343|TWO_SIDED|95.0|-12.7|36.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||36.8|-12.7|0.343
70863816|NCT02038452|141213249|SUPERIORITY||Odds Ratio (OR)|0.44||||0.018|TWO_SIDED|95.0|0.22|0.87|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||0.87|0.22|0.018
71137672|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|-7.9||||0.585|TWO_SIDED|95.0|-36.1|20.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||20.3|-36.1|0.585
71137673|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|-30.0||||0.539|TWO_SIDED|95.0|-50.1|-9.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||-9.9|-50.1|0.539
70863817|NCT02038452|141213252|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.5|TWO_SIDED|95.0|-0.11|0.23|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||0.23|-0.11|0.500
71137674|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|-15.7||||0.277|TWO_SIDED|95.0|-40.8|9.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||9.3|-40.8|0.277
70863818|NCT02038452|141213253|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.21|TWO_SIDED|95.0|-0.07|0.33|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms||The main treatment analyses were based on intention to treat approach||0.33|-0.07|0.21
71137675|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|-15.7||||0.422|TWO_SIDED|95.0|-42.9|11.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||11.5|-42.9|0.422
71137676|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-46.5|46.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||46.5|-46.5|1.000
71137677|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|-10.7||||0.454|TWO_SIDED|95.0|-34.9|13.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||13.5|-34.9|0.454
71137678|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|-17.9||||0.364|TWO_SIDED|95.0|-41.1|5.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||5.4|-41.1|0.364
71137679|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|10.0||||0.544|TWO_SIDED|95.0|-35.2|55.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||55.2|-35.2|0.544
71137680|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|-5.5||||0.663|TWO_SIDED|95.0|-25.5|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||14.6|-25.5|0.663
71137681|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|-15.0||||0.251|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||0.6|-30.6|0.251
71137682|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared|||Clinical non-responders, Week 44||3.1|-23.1|1.000
71137683|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|-5.2||||0.606|TWO_SIDED|95.0|-21.2|10.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||10.8|-21.2|0.606
70863819|NCT02038452|141213254|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.96|TWO_SIDED|95.0|-0.175|0.166|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||0.166|-0.175|0.96
70863820|NCT02038452|141213255|SUPERIORITY||Mean Difference (Final Values)|0.79||||0.055|TWO_SIDED|95.0|-0.02|1.59|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||1.59|-0.02|0.055
71137684|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|-2.9||||1|TWO_SIDED|95.0|-21.7|16.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||16.0|-21.7|1.000
71137685|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||3.1|-23.1|1.000
71137686|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|-0.5||||1|TWO_SIDED|95.0|-18.7|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||17.7|-18.7|1.000
71137687|NCT02365649|141776318|SUPERIORITY||Risk Difference (RD)|-10.0||||0.501|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||3.1|-23.1|0.501
70863821|NCT02038452|141213256|SUPERIORITY||Odds Ratio (OR)|1.12||||0.76|TWO_SIDED|95.0|0.55|2.2|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||2.20|0.55|0.76
70863822|NCT02038452|141213257|SUPERIORITY||Odds Ratio (OR)|1.66||||0.23|TWO_SIDED|95.0|0.73|3.77|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression for sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||3.77|0.73|0.23
71137688|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|17.5||||0.633|TWO_SIDED|95.0|-13.0|48.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||48.0|-13.0|0.633
70863823|NCT02038452|141213258|SUPERIORITY||Odds Ratio (OR)|1.28||||0.66|TWO_SIDED|95.0|0.41|3.98|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||3.98|0.41|0.66
70863824|NCT02038452|141213259|SUPERIORITY||Odds Ratio (OR)|1.43||||0.66|TWO_SIDED|95.0|0.28|7.34|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||7.34|0.28|0.66
70863825|NCT02038452|141213260|SUPERIORITY||Odds Ratio (OR)|1.42||||0.4|TWO_SIDED|95.0|0.63|3.18|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||3.18|0.63|0.40
70863826|NCT02038452|141213261|SUPERIORITY||Odds Ratio (OR)|1.99||||0.2|TWO_SIDED|95.0|0.7|5.66|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||5.66|0.70|0.20
70863827|NCT02038452|141213262|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.001|TWO_SIDED|95.0|-0.53|-0.14||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||-0.14|-0.53|0.001
70863828|NCT02038452|141213263|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.74|TWO_SIDED|95.0|-0.17|0.24||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||0.24|-0.17|0.74
70863829|NCT02038452|141213264|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.41|TWO_SIDED|95.0|-0.3|0.12||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||0.12|-0.30|0.41
70863830|NCT02038452|141213265|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.58|TWO_SIDED|95.0|-0.16|0.28||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||0.28|-0.16|0.58
70863831|NCT02038452|141213266|SUPERIORITY||Mean Difference (Final Values)|-0.98||||0.009|TWO_SIDED|95.0|-1.72|-0.24||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||-0.24|-1.72|0.009
70863832|NCT02038452|141213267|SUPERIORITY||Mean Difference (Final Values)|0.76||||0.058|TWO_SIDED|95.0|-0.02|1.54||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||1.54|-0.02|0.058
70863833|NCT02038452|141213268|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.95|TWO_SIDED|95.0|-0.79|0.85||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||0.85|-0.79|0.95
70863834|NCT02038452|141213269|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.35|TWO_SIDED|95.0|-0.45|1.26||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||1.26|-0.45|0.35
70863835|NCT02038452|141213270|SUPERIORITY||Mean Difference (Final Values)|-0.36|||<|0.001|TWO_SIDED|95.0|-0.54|-0.19|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.19|-0.54|<0.001
70863836|NCT02038452|141213271|SUPERIORITY||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.59|-0.21|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.21|-0.59|<0.001
70863837|NCT02038452|141213272|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.005|TWO_SIDED|95.0|-0.44|-0.08|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.08|-0.44|0.005
71137689|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|30.0||||0.0024|TWO_SIDED|95.0|9.9|50.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||50.1|9.9|0.0024
71137690|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-34.8|34.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||34.8|-34.8|1.000
71137691|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-39.8|29.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||29.8|-39.8|1.000
71137692|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|1.3||||1|TWO_SIDED|95.0|-24.7|27.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||27.2|-24.7|1.000
71137693|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|-20.0||||0.384|TWO_SIDED|95.0|-55.1|15.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||15.1|-55.1|0.384
71137694|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|25.0||||0.281|TWO_SIDED|95.0|6.0|44.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||44.0|6.0|0.281
71137695|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-28.5|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||28.5|-28.5|1.000
70863838|NCT02038452|141213273|SUPERIORITY||Mean Difference (Final Values)|-1.05||||0.002|TWO_SIDED|95.0|-1.72|-0.38|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.38|-1.72|0.002
70863839|NCT02038452|141213274|SUPERIORITY||Odds Ratio (OR)|0.35||||0.006|TWO_SIDED|95.0|0.17|0.74|||Regression, Logistic|Complete case analysis as a sensitivity analysis was performed. Logistic regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.74|0.17|0.006
71137696|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|-35.0||||0.108|TWO_SIDED|95.0|-70.8|0.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||0.8|-70.8|0.108
71137697|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|12.5||||0.686|TWO_SIDED|95.0|-27.6|52.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||52.6|-27.6|0.686
71137698|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|25.0||||0.126|TWO_SIDED|95.0|-5.5|55.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||55.5|-5.5|0.126
71137699|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|-10.0||||0.709|TWO_SIDED|95.0|-47.4|27.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||27.4|-47.4|0.709
70863840|NCT02038452|141213275|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.58|TWO_SIDED|95.0|-0.13|0.24|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.24|-0.13|0.58
70863841|NCT02038452|141213276|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.25|TWO_SIDED|95.0|-0.09|0.35|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.35|-0.09|0.25
70863842|NCT02038452|141213277|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.93|TWO_SIDED|95.0|-0.17|0.18|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.18|-0.17|0.93
70863843|NCT02038452|141213278|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.052|TWO_SIDED|95.0|-0.01|1.61|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||1.61|-0.01|0.052
70863844|NCT02038452|141213279|SUPERIORITY||Odds Ratio (OR)|1.29||||0.53|TWO_SIDED|95.0|0.58|2.88|||Regression, Logistic|Complete case analysis as a sensitivity analysis was performed. Logistic regression adjusted for baseline score, sex, age, and duration of symptoms.||||2.88|0.58|0.53
70863845|NCT02038452|141213280|SUPERIORITY||Odds Ratio (OR)|1.43||||0.41|TWO_SIDED|95.0|0.61|3.34|||Regression, Logistic|Complete case analysis as a sensitivity analysis was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||||3.34|0.61|0.41
70863846|NCT02038452|141213282|SUPERIORITY||Odds Ratio (OR)|1.32||||0.52|TWO_SIDED|95.0|0.57|3.06|||Regression, Logistic|Complete case analysis as a sensitivity analysis was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||||3.06|0.57|0.52
70863847|NCT02038452|141213283|SUPERIORITY||Odds Ratio (OR)|2.05||||0.18|TWO_SIDED|95.0|0.72|5.78|||Regression, Logistic|Complete case analysis as a sensitivity analysis was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||||5.78|0.72|0.18
71137700|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|37.5||||0.099|TWO_SIDED|95.0|5.8|69.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||69.2|5.8|0.099
71137701|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|18.8||||0.257|TWO_SIDED|95.0|-12.8|50.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||50.3|-12.8|0.257
71137702|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-38.0|38.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||38.0|-38.0|1.000
71137703|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|15.6||||0.465|TWO_SIDED|95.0|-19.5|50.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||50.7|-19.5|0.465
70863848|NCT02038452|141213284|SUPERIORITY||Mean Difference (Final Values)|-0.36|||<|0.001|TWO_SIDED|95.0|-0.55|-0.18|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.18|-0.55|<0.001
70863849|NCT02038452|141213285|SUPERIORITY||Mean Difference (Final Values)|-0.39|||<|0.001|TWO_SIDED|95.0|-0.59|-0.19|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.19|-0.59|<0.001
70863850|NCT02038452|141213286|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.003|TWO_SIDED|95.0|-0.46|-0.09|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.09|-0.46|0.003
70863851|NCT02038452|141213287|SUPERIORITY||Mean Difference (Final Values)|-1.16||||0.001|TWO_SIDED|95.0|-1.85|-0.48|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.48|-1.85|0.001
70863852|NCT02038452|141213288|SUPERIORITY||Odds Ratio (OR)|0.34||||0.007|TWO_SIDED|95.0|0.16|0.74|||Regression, Logistic|Per protocol analysis on complete date was performed. Logistic regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.74|0.16|0.007
70863853|NCT02038452|141213289|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.63|TWO_SIDED|95.0|-0.15|0.25|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.25|-0.15|0.63
70863854|NCT02038452|141213290|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.28|TWO_SIDED|95.0|-0.1|0.35|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.35|-0.10|0.28
70863855|NCT02038452|141213291|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.9|TWO_SIDED|95.0|-0.18|0.2|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.20|-0.18|0.900
70863856|NCT02038452|141213292|SUPERIORITY||Mean Difference (Final Values)|0.74||||0.09|TWO_SIDED|95.0|-0.11|1.59|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||1.59|-0.11|0.09
70863857|NCT02038452|141213293|SUPERIORITY||Odds Ratio (OR)|1.26||||0.58|TWO_SIDED|95.0|0.56|2.85|||Regression, Logistic|Per protocol analysis on complete date was performed. Logistic regression adjusted for baseline score, sex, age, and duration of symptoms.||||2.85|0.56|0.58
70863858|NCT02038452|141213294|SUPERIORITY||Odds Ratio (OR)|1.31||||0.52|TWO_SIDED|95.0|0.57|3.01|||Regression, Logistic|Per protocol analysis on complete date was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||||3.01|0.57|0.52
70863859|NCT02038452|141213296|SUPERIORITY||Odds Ratio (OR)|1.25||||0.61|TWO_SIDED|95.0|0.53|2.95|||Regression, Logistic|Per protocol analysis on complete date was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||||2.95|0.53|0.61
70863860|NCT02038452|141213297|SUPERIORITY||Odds Ratio (OR)|2.24||||0.14|TWO_SIDED|95.0|0.77|6.58|||Regression, Logistic|Per protocol analysis on complete date was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||||6.58|0.77|0.14
70863861|NCT02038452|141213298|SUPERIORITY||Mean Difference (Final Values)|-0.52||||0.014|TWO_SIDED|95.0|-0.93|-0.12|||Regression, Linear|Sub group analysis on complete data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.12|-0.93|0.014
70863862|NCT02038452|141213299|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.53|TWO_SIDED|95.0|-0.5|0.26|||Regression, Linear|Sub group analysis on complete data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.26|-0.50|0.53
70863863|NCT02038452|141213300|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.015|TWO_SIDED|95.0|-0.44|-0.05|||Regression, Linear|Sub group analysis on complete data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.05|-0.44|0.015
70863864|NCT02038452|141213301|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.002|TWO_SIDED|95.0|-0.97|-0.23|||Regression, Linear|Sub group analysis on complete data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.23|-0.97|0.002
70863865|NCT02038452|141213302|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.25|TWO_SIDED|95.0|-0.6|0.16|||Regression, Linear|Sub group analysis on complete data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.16|-0.60|0.25
70863866|NCT02038452|141213303|SUPERIORITY||Mean Difference (Final Values)|33.54|||||TWO_SIDED|95.0|-94.57|145.59|||Regression, Linear|Comparison of outcome between treatment groups performed on multiply imputed data||||145.59|-94.57|
70863867|NCT02038452|141213304|SUPERIORITY||Mean Difference (Final Values)|47.06|||||TWO_SIDED|95.0|-104.84|187.31|||Regression, Linear|Comparison of outcome between treatment groups on complete data.||||187.31|-104.84|
70863868|NCT02038452|141213305|SUPERIORITY||Mean Difference (Final Values)|113.15|||||TWO_SIDED|95.0|-37.09|279.21|||Regression, Linear|Comparison of outcome between treatment groups||||279.21|-37.09|
70863869|NCT02038452|141213306|SUPERIORITY||Mean Difference (Final Values)|71.1|||||TWO_SIDED|95.0|-120.84|291.24|||Regression, Linear|Comparison of outcome between treatment groups||||291.24|-120.84|
71137704|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|3.9||||0.745|TWO_SIDED|95.0|-19.3|27.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||27.0|-19.3|0.745
70863870|NCT02038452|141213307|SUPERIORITY||Mean Difference (Final Values)|0.008|||||TWO_SIDED|95.0|-0.01|0.02|||Regression, Linear|||||0.02|-0.01|
70863871|NCT02038452|141213308|SUPERIORITY||Mean Difference (Final Values)|-0.003|||||TWO_SIDED|95.0|-0.034|0.027|||Regression, Linear|||||0.027|-0.034|
70863872|NCT02038452|141213309|SUPERIORITY||Mean Difference (Final Values)|-0.022|||||TWO_SIDED|95.0|-0.093|0.045|||Regression, Linear|||||0.045|-0.093|
70863873|NCT01460368|141213353|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.63|||||TWO_SIDED|90.0|-1.38|2.63|||||Treatment comparison at 2 hours.|||2.63|-1.38|
70863874|NCT01460368|141213353|SUPERIORITY_OR_OTHER||Least Squares Means Difference|3.69|||||TWO_SIDED|90.0|1.67|5.71|||||Treatment comparison at 4 hours.|||5.71|1.67|
70863875|NCT01460368|141213353|SUPERIORITY_OR_OTHER||Least Squares Means Difference|9.14|||||TWO_SIDED|90.0|7.12|11.16|||||Treatment comparison at 6 hours.|||11.16|7.12|
70863876|NCT01460368|141213353|SUPERIORITY_OR_OTHER||Least Squares Means Difference|9.08|||||TWO_SIDED|90.0|7.1|11.07|||||Treatment comparison at 8 hours.|||11.07|7.10|
70863877|NCT01460368|141213353|SUPERIORITY_OR_OTHER||Least Squares Means Difference|-0.15|||||TWO_SIDED|90.0|-2.14|1.85|||||Treatment comparison at 12 hours.|||1.85|-2.14|
70863878|NCT01460368|141213353|SUPERIORITY_OR_OTHER||Least Squares Means Difference|3.63|||||TWO_SIDED|90.0|1.63|5.63|||||Treatment comparison at 24 hours.|||5.63|1.63|
70863879|NCT01460368|141213354|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|8.07|||||TWO_SIDED|90.0|5.21|10.94|||||Treatment comparison at 2 hours.|||10.94|5.21|
70863880|NCT01460368|141213354|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|10.56|||||TWO_SIDED|90.0|7.69|13.43|||||Treatment comparison at 4 hours.|||13.43|7.69|
70863881|NCT05055453|141213357|OTHER|A Shapiro Wilks test was used to test for normal distribution of the data.|||||<|0.001||||||"Result for comparison between automatic only and preferred app settings."|Durbin-Conover Pairwise Comparison|||||||<0.001
70863882|NCT05055453|141213357|OTHER||||||<|0.001||||||"Result of comparison between preferred app setting and extreme app setting"|Durbin-Conover Pairwise Comparison|||A Shapiro Wilks test was used to test for normal distribution of the data.||||< 0.001
70863883|NCT05055453|141213357|OTHER|"Result of comparison between automatic only and extreme app setting."||||||0.002|||||||Durbin-Conover Pairwise Comparison|||A Shapiro Wilks test was used to test for normal distribution of the data.||||0.002
70863884|NCT05055453|141213358|OTHER|Analysis of first home trial|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70863885|NCT05055453|141213358|OTHER||||||<|0.001|||||||t-test, 2 sided|||Analysis of second home trial||||<.001
70863886|NCT01224665|141213359|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.45|TWO_SIDED|95.0|0.86|1.4||Using an intention-to-treat analysis, we specified a stratified log-rank test with a one-sided alpha of 0.025.|Log Rank|Adjustments were made for the following stratification factors: neoadjuvant chemotherapy, clinical T stage, and Zubrod performance score.|Adjustments were made for the following stratification factors: neoadjuvant chemotherapy, clinical T stage, and Zubrod performance score.|3-year DFS estimates of 55% among participants undergoing SLND and 65% undergoing ELND were used to estimate the target HR. Assuming exponential DFS distribution, 5 years of enrollment, 3 years of follow-up, and 564 eligible participants, the trial would have 85% power to detect a 28% lower risk of recurrence or death with ELND than SLND.||1.40|0.86|0.45
70863887|NCT01224665|141213360|SUPERIORITY||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.88|1.45|||||Adjustments were made for the following stratification factors: neoadjuvant chemotherapy, clinical T stage, and Zubrod performance score.|We assumed that the standard lymphadenectomy arm has 5-year survival of 55%, so we had 83% statistical power to detect a hazard ratio of 0.72 (55% vs. 65% survival at 5 years).||1.45|0.88|
70863888|NCT00257608|141213449|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.708||||0.0006|TWO_SIDED|95.0|0.58|0.864|||Log Rank|||||0.864|0.580|0.0006
70863889|NCT00257608|141213455|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.917||||0.5341|TWO_SIDED|95.0|0.698|1.205|||Log Rank|||||1.205|0.698|0.5341
70863890|NCT02053051|141213458|SUPERIORITY|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
70863891|NCT01854658|141213466|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 5 min post dose||||<0.0001
70863892|NCT01854658|141213466|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 15 min post dose||||<0.0001
70863893|NCT01854658|141213466|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 5 min post dose||||<0.0001
70863894|NCT01854658|141213466|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 15 min post dose||||<0.0001
71137705|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|-8.3||||0.512|TWO_SIDED|95.0|-32.6|16.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||16.1|-32.6|0.512
71137706|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|22.5||||0.281|TWO_SIDED|95.0|-12.2|57.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||57.2|-12.2|0.281
70863895|NCT01854658|141213466|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 5 min post dose||||<0.0001
70863896|NCT01854658|141213466|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 15 min post dose||||<0.0001
70863897|NCT02203071|141213476|SUPERIORITY|||||||0.61|||||||Fisher Exact|||||||0.61
70863898|NCT02203071|141213477|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||.001
70863899|NCT02203071|141213478|SUPERIORITY||||||>|0.11|||||||t-test, 2 sided|||||||>0.11
70863900|NCT02203071|141213479|SUPERIORITY||||||<|0.007|||||||ANOVA|||||||<0.007
70863901|NCT02203071|141213480|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
71137707|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|-8.1||||0.486|TWO_SIDED|95.0|-30.8|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||14.6|-30.8|0.486
71137708|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|-15.8||||0.212|TWO_SIDED|95.0|-39.5|8.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||8.0|-39.5|0.212
70863902|NCT02203071|141213481|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
70863903|NCT03793556|141213571|OTHER||Mean Difference (Final Values)|-2.5|STANDARD_DEVIATION|9.27||0.276|TWO_SIDED|95.0|-7.03|2.04|||Unpaired t test|||||2.04|-7.03|0.276
70863904|NCT03793556|141213572|OTHER|||||||0.0157|||||||ANOVA|The ANOVA model examined the entire curve profile.||||||0.0157
70863905|NCT03793556|141213582|OTHER|||||||0.0496|||||||Chi-squared|||||||0.0496
70863906|NCT03793556|141213584|OTHER|||||||0.0065|||||||ANOVA|||||||0.0065
70863907|NCT04612790|141213592|OTHER||Difference in percentage of responders|6.7||||0.509|TWO_SIDED|95.0|-10.9|24.29|||Logistic regression model with Firth adj|||Estimates were from a logistic regression model using the Firth adjustment (adj) that included treatment group, baseline disease severity (moderate, severe) and time of BP diagnosis (participants with newly diagnosed BP, participants with a previous diagnosis of BP who have relapsed) as categorical covariates.||24.29|-10.90|0.509
70863908|NCT00785928|141213598|SUPERIORITY_OR_OTHER|||||||0.059||95.0||||This is p-value for the fitted ACR50 response rate and is based on the dose-response regression model and comes from the joint test of linear and quadratic dose response (response=dose+dose\^2) from the likelihood ratio test.|Linear-quadratic regression model|||||||0.059
70863909|NCT00785928|141213598|SUPERIORITY_OR_OTHER||ED95|119.0||||0.042||95.0||||This is the p-value for the estimated dose level of the smallest dose, in milligrams (mg), that achieves at least 95% of the maximal efficacy (ED95) and is based on the comparisons that the ED95 yields a higher fitted response rate than placebo.|Linear-quadratic regression model|This is ED95 in mg.||||||0.042
70863910|NCT00785928|141213599|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||This is the p-value for the fitted ACR20 response rate and is based on the dose-response regression model and comes from the joint test of linear and quadratic dose response (response=dose+dose\^2) from the likelihood ratio test.|Linear-quadratic regression model|||||||0.044
70863911|NCT00785928|141213599|SUPERIORITY_OR_OTHER||ED95|118.5||||0.005||95.0||||This p-value is for estimated dose level of the smallest dose, in milligrams (mg), that achieves at least 95% of the maximal efficacy (ED95) of the ACR20 and is based on the comparisons that the ED95 yields a higher fitted response rate than placebo.|Linear-quadratic regression model|This is the ED95 in mg.||||||0.005
70863912|NCT00785928|141213600|SUPERIORITY_OR_OTHER|||||||0.623||95.0||||Pairwise comparison (2-sided) of 1 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.623
70863913|NCT00785928|141213600|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||Pairwise comparison (2-sided) of 3 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.160
70863914|NCT00785928|141213600|SUPERIORITY_OR_OTHER|||||||0.568||95.0||||Pairwise comparison (2-sided) of 10 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.568
70863915|NCT00785928|141213600|SUPERIORITY_OR_OTHER|||||||0.633||95.0||||Pairwise comparison (2-sided) of 30 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.633
71137709|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|11.9||||0.697|TWO_SIDED|95.0|-22.3|46.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||46.0|-22.3|0.697
70863916|NCT00785928|141213600|SUPERIORITY_OR_OTHER|||||||0.754||95.0||||Pairwise comparison (2-sided) of 60 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.754
70863917|NCT00785928|141213600|SUPERIORITY_OR_OTHER|||||||0.289||95.0||||Pairwise comparison (2-sided) of 120 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.289
70863918|NCT00785928|141213601|SUPERIORITY_OR_OTHER|||||||0.671||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.671
70863919|NCT00785928|141213601|SUPERIORITY_OR_OTHER|||||||0.696||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.696
70863920|NCT00785928|141213601|SUPERIORITY_OR_OTHER|||||||0.367||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.367
70863921|NCT00785928|141213601|SUPERIORITY_OR_OTHER|||||||0.645||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.645
70863922|NCT00785928|141213601|SUPERIORITY_OR_OTHER|||||||0.944||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.944
70863923|NCT00785928|141213601|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.133
71137710|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|-1.7||||0.88|TWO_SIDED|95.0|-23.2|19.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||19.9|-23.2|0.880
71137711|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|-10.7||||0.355|TWO_SIDED|95.0|-32.7|11.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||11.2|-32.7|0.355
71137712|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|8.1||||0.678|TWO_SIDED|95.0|-23.7|39.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||39.9|-23.7|0.678
70863924|NCT00785928|141213602|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||Pairwise comparison (1-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.457
70863925|NCT00785928|141213602|SUPERIORITY_OR_OTHER|||||||0.874||95.0||||Pairwise comparison (1-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.874
70863926|NCT00785928|141213602|SUPERIORITY_OR_OTHER|||||||0.278||95.0||||Pairwise comparison (1-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.278
70863927|NCT00785928|141213602|SUPERIORITY_OR_OTHER|||||||0.357||95.0||||Pairwise comparison (1-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.357
70863928|NCT00785928|141213602|SUPERIORITY_OR_OTHER|||||||0.271||95.0||||Pairwise comparison (1-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.271
70863929|NCT00785928|141213602|SUPERIORITY_OR_OTHER|||||||0.048||95.0||||Pairwise comparison (1-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.048
70863930|NCT00785928|141213603|SUPERIORITY_OR_OTHER|||||||0.875||95.0||||This p-value is from 2-sided comparison of 1 mg LY2127399 versus placebo using Fisher's exact test for the 3 levels of EULAR response (good, moderate, no).|Fisher Exact|||||||0.875
70863931|NCT00785928|141213603|SUPERIORITY_OR_OTHER|||||||1||95.0||||This p-value is from 2-sided comparison of 3 mg LY2127399 versus placebo using Fisher's exact test for the 3 levels of EULAR response (good, moderate, no).|Fisher Exact|||||||1.000
70863932|NCT00785928|141213603|SUPERIORITY_OR_OTHER|||||||1||95.0||||This p-value is from 2-sided comparison of 10 mg LY2127399 versus placebo using Fisher's exact test for the 3 levels of EULAR response (good, moderate, no).|Fisher Exact|||||||1.000
70863933|NCT00785928|141213603|SUPERIORITY_OR_OTHER|||||||0.304||95.0||||This p-value is from a 2-sided comparison of 30 mg LY2127399 versus placebo using a Chi-square test for the 3 levels of EULAR response (good, moderate, no).|Chi-squared|||||||0.304
70863934|NCT00785928|141213603|SUPERIORITY_OR_OTHER|||||||0.489||95.0||||This p-value is from a 2-sided comparison of 60 mg LY2127399 versus placebo using a Chi-square test for the 3 levels of EULAR response (good, moderate, no).|Chi-squared|||||||0.489
70863935|NCT00785928|141213603|SUPERIORITY_OR_OTHER|||||||0.091||95.0||||This p-value is from a 2-sided comparison of 120 mg LY2127399 versus placebo using a Chi-square test for the 3 levels of EULAR response (good, moderate, no).|Chi-squared|||||||0.091
70863936|NCT00785928|141213604|SUPERIORITY_OR_OTHER|||||||0.746||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.746
70863937|NCT00785928|141213604|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.393
70863938|NCT00785928|141213604|SUPERIORITY_OR_OTHER|||||||0.549||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.549
70863939|NCT00785928|141213604|SUPERIORITY_OR_OTHER|||||||0.619||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.619
70863940|NCT00785928|141213604|SUPERIORITY_OR_OTHER|||||||0.893||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.893
70863941|NCT00785928|141213604|SUPERIORITY_OR_OTHER|||||||0.066||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.066
70863942|NCT00785928|141213605|SUPERIORITY_OR_OTHER|||||||0.583||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.583
70863943|NCT00785928|141213605|SUPERIORITY_OR_OTHER|||||||0.311||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.311
71137713|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|1.7||||0.873|TWO_SIDED|95.0|-18.6|21.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||21.9|-18.6|0.873
70863944|NCT00785928|141213605|SUPERIORITY_OR_OTHER|||||||0.752||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.752
70863945|NCT00785928|141213605|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.737
70863946|NCT00785928|141213605|SUPERIORITY_OR_OTHER|||||||0.522||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.522
70863947|NCT00785928|141213605|SUPERIORITY_OR_OTHER|||||||0.073||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.073
70863948|NCT00785928|141213606|SUPERIORITY_OR_OTHER|||||||0.969||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.969
70863949|NCT00785928|141213606|SUPERIORITY_OR_OTHER|||||||0.352||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.352
70863950|NCT00785928|141213606|SUPERIORITY_OR_OTHER|||||||0.406||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.406
70863951|NCT00785928|141213606|SUPERIORITY_OR_OTHER|||||||0.266||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.266
70863952|NCT00785928|141213606|SUPERIORITY_OR_OTHER|||||||0.708||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.708
70863953|NCT00785928|141213606|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.012
70863954|NCT00785928|141213607|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.880
70863955|NCT00785928|141213607|SUPERIORITY_OR_OTHER|||||||0.575||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.575
70863956|NCT00785928|141213607|SUPERIORITY_OR_OTHER|||||||0.992||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.992
71137714|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|-0.1||||0.99|TWO_SIDED|95.0|-22.3|22.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||22.0|-22.3|0.990
71137715|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|8.1||||0.678|TWO_SIDED|95.0|-23.7|39.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||39.9|-23.7|0.678
71137716|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|4.6||||0.663|TWO_SIDED|95.0|-16.0|25.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||25.2|-16.0|0.663
71137717|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|-8.8||||0.494|TWO_SIDED|95.0|-28.7|11.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||11.0|-28.7|0.494
70863957|NCT00785928|141213607|SUPERIORITY_OR_OTHER|||||||0.646||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.646
70863958|NCT00785928|141213607|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.054
70863959|NCT00785928|141213607|SUPERIORITY_OR_OTHER|||||||0.472||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.472
70863960|NCT00785928|141213608|SUPERIORITY_OR_OTHER|||||||0.952||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.952
70863961|NCT00785928|141213608|SUPERIORITY_OR_OTHER|||||||0.085||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.085
70863962|NCT00785928|141213608|SUPERIORITY_OR_OTHER|||||||0.143||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.143
71137718|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|23.2||||0.169|TWO_SIDED|95.0|-1.6|48.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||48.1|-1.6|0.169
71137719|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|30.6||||0.005|TWO_SIDED|95.0|11.5|49.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||49.7|11.5|0.005
71137720|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|0.7||||0.963|TWO_SIDED|95.0|-26.8|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||28.1|-26.8|0.963
70863963|NCT00785928|141213608|SUPERIORITY_OR_OTHER|||||||0.242||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.242
70863964|NCT00785928|141213608|SUPERIORITY_OR_OTHER|||||||0.317||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.317
70863965|NCT00785928|141213608|SUPERIORITY_OR_OTHER|||||||0.456||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.456
70863966|NCT00785928|141213609|SUPERIORITY_OR_OTHER|||||||0.833||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA|||||||0.833
70863967|NCT00785928|141213609|SUPERIORITY_OR_OTHER|||||||0.826||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA|||||||0.826
70863968|NCT00785928|141213609|SUPERIORITY_OR_OTHER|||||||0.091||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA|||||||0.091
70863969|NCT00785928|141213609|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA|||||||0.127
70863970|NCT00785928|141213609|SUPERIORITY_OR_OTHER|||||||0.243||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA|||||||0.243
70863971|NCT00785928|141213609|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA|||||||0.037
70863972|NCT00785928|141213610|SUPERIORITY_OR_OTHER|||||||0.562||95.0||||P-value for physical health component. Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.562
71137721|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|6.7||||0.729|TWO_SIDED|95.0|-19.8|33.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||33.2|-19.8|0.729
71137722|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|-2.9||||0.804|TWO_SIDED|95.0|-25.8|20.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||20.0|-25.8|0.804
71137723|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|-14.0||||0.306|TWO_SIDED|95.0|-41.1|13.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||13.1|-41.1|0.306
71137724|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|12.9||||0.497|TWO_SIDED|95.0|-14.1|40.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||40.0|-14.1|0.497
71137725|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|-0.1||||0.993|TWO_SIDED|95.0|-24.0|23.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||23.8|-24.0|0.993
71137726|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|-23.5||||0.101|TWO_SIDED|95.0|-51.2|4.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||4.1|-51.2|0.101
71137727|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|7.1||||0.655|TWO_SIDED|95.0|-24.0|38.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||38.3|-24.0|0.655
71137728|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|15.5||||0.221|TWO_SIDED|95.0|-9.0|40.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||40.0|-9.0|0.221
71137729|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|-7.9||||0.585|TWO_SIDED|95.0|-36.1|20.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||20.3|-36.1|0.585
71137730|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|24.6||||0.124|TWO_SIDED|95.0|-4.8|53.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||53.9|-4.8|0.124
71137731|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|15.2||||0.234|TWO_SIDED|95.0|-9.5|39.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||39.9|-9.5|0.234
71137732|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|-4.8||||0.741|TWO_SIDED|95.0|-32.9|23.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||23.4|-32.9|0.741
71137733|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|-25.0||||0.544|TWO_SIDED|95.0|-44.0|-6.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||-6.0|-44.0|0.544
70863973|NCT00785928|141213610|SUPERIORITY_OR_OTHER|||||||0.539||95.0||||P-value for physical health component. Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.539
71137734|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|-15.5||||0.238|TWO_SIDED|95.0|-38.2|7.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||7.3|-38.2|0.238
71137735|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|-17.9||||0.364|TWO_SIDED|95.0|-41.1|5.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||5.4|-41.1|0.364
71137736|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-46.5|46.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||46.5|-46.5|1.000
71137737|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|-10.7||||0.454|TWO_SIDED|95.0|-34.9|13.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||13.5|-34.9|0.454
71137738|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|-25.0||||0.063|TWO_SIDED|95.0|-44.0|-6.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||-6.0|-44.0|0.063
71137739|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|10.0||||0.544|TWO_SIDED|95.0|-35.2|55.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||55.2|-35.2|0.544
71137740|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|-5.5||||0.663|TWO_SIDED|95.0|-25.5|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||14.6|-25.5|0.663
71137741|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|-15.0||||0.251|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||0.6|-30.6|0.251
71137742|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||4.6|-14.6|1.000
71137743|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|-0.2||||1|TWO_SIDED|95.0|-13.4|13.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||13.0|-13.4|1.000
71137744|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|2.1||||1|TWO_SIDED|95.0|-14.4|18.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||18.7|-14.4|1.000
71137745|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||3.1|-23.1|1.000
71137746|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|-0.5||||1|TWO_SIDED|95.0|-18.7|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||17.7|-18.7|1.000
71137747|NCT02365649|141776319|SUPERIORITY||Risk Difference (RD)|-10.0||||0.501|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||3.1|-23.1|0.501
70863974|NCT00785928|141213610|SUPERIORITY_OR_OTHER|||||||0.304||95.0||||P-value for physical health component. Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.304
71137748|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|30.0||||0.155|TWO_SIDED|95.0|9.9|50.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||50.1|9.9|0.155
71137749|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|30.0||||0.024|TWO_SIDED|95.0|9.9|50.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||50.1|9.9|0.024
71137750|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|-3.3||||1|TWO_SIDED|95.0|-40.1|33.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||33.4|-40.1|1.000
71137751|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|-8.6||||0.633|TWO_SIDED|95.0|-46.4|29.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||29.2|-46.4|0.633
71137752|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|1.3||||1|TWO_SIDED|95.0|-24.7|27.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||27.2|-24.7|1.000
71137753|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|-24.4||||0.209|TWO_SIDED|95.0|-61.3|12.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||12.5|-61.3|0.209
71137754|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|25.0||||0.283|TWO_SIDED|95.0|6.0|44.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||44.0|6.0|0.283
71137755|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-28.5|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||28.5|-28.5|1.000
71137756|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|-41.7||||0.048|TWO_SIDED|95.0|-77.8|-5.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||-5.5|-77.8|0.048
71137757|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|21.4||||0.408|TWO_SIDED|95.0|-18.6|61.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||61.4|-18.6|0.408
71137758|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|25.0||||0.126|TWO_SIDED|95.0|-5.5|55.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||55.5|-5.5|0.126
71137759|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|-16.7||||0.454|TWO_SIDED|95.0|-54.5|21.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||21.1|-54.5|0.454
71137760|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|35.7||||0.183|TWO_SIDED|95.0|1.8|69.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||69.7|1.8|0.183
70863975|NCT00785928|141213610|SUPERIORITY_OR_OTHER|||||||0.832||95.0||||P-value for physical health component. Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.832
71137761|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|18.8||||0.257|TWO_SIDED|95.0|-12.8|50.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||50.3|-12.8|0.257
71137762|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|-5.6||||1|TWO_SIDED|95.0|-44.7|33.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|ANOVA||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||33.6|-44.7|1.000
71137763|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|33.3||||0.307|TWO_SIDED|95.0|-9.7|76.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||76.3|-9.7|0.307
71137764|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|33.3||||0.172|TWO_SIDED|95.0|-4.1|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||70.8|-4.1|0.172
71137765|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|7.1||||1|TWO_SIDED|95.0|-40.9|55.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||55.1|-40.9|1.000
70863976|NCT00785928|141213610|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value for physical health component. Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.010
71137766|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|13.3||||1|TWO_SIDED|95.0|-27.8|54.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||54.5|-27.8|1.000
71137767|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|-11.7||||0.675|TWO_SIDED|95.0|-51.5|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||28.1|-51.5|0.675
71137768|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|-12.9||||0.644|TWO_SIDED|95.0|-59.2|33.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||33.5|-59.2|0.644
71137769|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-50.6|50.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||50.6|-50.6|1.000
71137770|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-33.4|50.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||50.0|-33.4|1.000
71137771|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|7.1||||1|TWO_SIDED|95.0|-40.9|55.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||55.1|-40.9|1.000
70863977|NCT00785928|141213610|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||P-value for physical health component. Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.980
70863978|NCT00785928|141213610|SUPERIORITY_OR_OTHER|||||||0.569||95.0||||P-value for mental health component. Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.569
71137772|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-50.6|50.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||50.6|-50.6|1.000
71137773|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-33.4|50.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||50.0|-33.4|1.000
70863979|NCT00785928|141213610|SUPERIORITY_OR_OTHER|||||||0.953||95.0||||P-value for mental health component. Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.953
70863980|NCT00785928|141213610|SUPERIORITY_OR_OTHER|||||||0.647||95.0||||P-value for mental health component. Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.647
70863981|NCT00785928|141213610|SUPERIORITY_OR_OTHER|||||||0.507||95.0||||P-value for mental health component. Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.507
70863982|NCT00785928|141213610|SUPERIORITY_OR_OTHER|||||||0.821||95.0||||P-value for mental health component. Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.821
70863983|NCT00785928|141213610|SUPERIORITY_OR_OTHER|||||||0.045||95.0||||P-value for mental health component. Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.045
70863984|NCT00785928|141213613|SUPERIORITY_OR_OTHER|||||||0.236||95.0||||Pairwise (2-sided) comparisons of 1 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.236
70863985|NCT00785928|141213613|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||Pairwise (2-sided) comparisons of 3 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.038
70863986|NCT00785928|141213613|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||Pairwise (2-sided) comparisons of 10 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.025
70863987|NCT00785928|141213613|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Pairwise (2-sided) comparisons of 30 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.005
71137774|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|7.1||||1|TWO_SIDED|95.0|-40.9|55.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||55.1|-40.9|1.000
70863988|NCT00785928|141213613|SUPERIORITY_OR_OTHER|||||||0.734||95.0||||Pairwise (2-sided) comparisons of 60 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.734
70863989|NCT00785928|141213613|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||Pairwise (2-sided) comparisons of 120 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.035
70863990|NCT00785928|141213614|SUPERIORITY_OR_OTHER|||||||0.901||95.0||||P-value for IgG. Pairwise comparison (2-sided) of 1 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.901
70863991|NCT00785928|141213614|SUPERIORITY_OR_OTHER|||||||0.84||95.0||||P-value for IgG. Pairwise comparison (2-sided) of 3 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.840
70863992|NCT00785928|141213614|SUPERIORITY_OR_OTHER|||||||0.882||95.0||||P-value for IgG. Pairwise comparison (2-sided) of 10 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.882
70863993|NCT00785928|141213614|SUPERIORITY_OR_OTHER|||||||0.225||95.0||||P-value for IgG. Pairwise comparison (2-sided) of 30 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.225
70863994|NCT00785928|141213614|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||P-value for IgG. Pairwise comparison (2-sided) of 60 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.340
70863995|NCT00785928|141213614|SUPERIORITY_OR_OTHER|||||||0.85||95.0||||P-value for IgG. Pairwise comparison (2-sided) of 120 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.850
70863996|NCT00785928|141213614|SUPERIORITY_OR_OTHER|||||||0.447||95.0||||P-value for IgM. Pairwise comparison (2-sided) of 1 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.447
70863997|NCT00785928|141213614|SUPERIORITY_OR_OTHER|||||||0.909||95.0||||P-value for IgM. Pairwise comparison (2-sided) of 3 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.909
70863998|NCT00785928|141213614|SUPERIORITY_OR_OTHER|||||||0.152||95.0||||P-value for IgM. Pairwise comparison (2-sided) of 10 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.152
71137775|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|10.0||||1|TWO_SIDED|95.0|-40.2|60.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||60.2|-40.2|1.000
71137776|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|18.3||||0.392|TWO_SIDED|95.0|-22.9|59.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||59.6|-22.9|0.392
71137777|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|2.9||||1|TWO_SIDED|95.0|-44.7|50.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||50.5|-44.7|1.000
71137778|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|29.0||||0.07|TWO_SIDED|95.0|6.5|51.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||51.5|6.5|0.070
71137779|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|29.5||||0.007|TWO_SIDED|95.0|9.8|49.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||49.2|9.8|0.007
71137780|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|3.3||||0.826|TWO_SIDED|95.0|-26.1|32.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||32.8|-26.1|0.826
71137781|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|0.3||||1|TWO_SIDED|95.0|-27.2|27.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||27.7|-27.2|1.000
71137782|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|-5.2||||0.649|TWO_SIDED|95.0|-27.8|17.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||17.3|-27.8|0.649
71137783|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|-16.7||||0.304|TWO_SIDED|95.0|-45.7|12.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||12.4|-45.7|0.304
71137784|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|10.3||||0.72|TWO_SIDED|95.0|-18.2|38.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||38.7|-18.2|0.720
71137785|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|1.2||||0.923|TWO_SIDED|95.0|-23.0|25.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||25.4|-23.0|0.923
71137786|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|-20.0||||0.197|TWO_SIDED|95.0|-50.4|10.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||10.4|-50.4|0.197
71137787|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|11.5||||0.486|TWO_SIDED|95.0|-20.4|43.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||43.5|-20.4|0.486
71137788|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|17.9||||0.168|TWO_SIDED|95.0|-7.0|42.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||42.7|-7.0|0.168
71137789|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|-3.3||||0.833|TWO_SIDED|95.0|-34.3|27.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||27.6|-34.3|0.833
71137790|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|22.6||||0.173|TWO_SIDED|95.0|-8.2|53.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||53.4|-8.2|0.173
71137791|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|17.6||||0.178|TWO_SIDED|95.0|-7.6|42.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||42.8|-7.6|0.178
71137792|NCT02365649|141776320|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-30.9|30.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|ANCOVA||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||30.9|-30.9|1.000
71137793|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|-27.8||||0.58|TWO_SIDED|95.0|-71.9|16.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||16.3|-71.9|0.580
71137794|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|-6.9||||1|TWO_SIDED|95.0|-53.6|39.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||39.7|-53.6|1.000
71137795|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|-24.4||||0.58|TWO_SIDED|95.0|-72.2|23.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||23.3|-72.2|0.580
71137796|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|-38.9||||0.287|TWO_SIDED|95.0|-83.0|5.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||5.2|-83.0|0.287
71137797|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|-5.6||||1|TWO_SIDED|95.0|-53.0|41.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||41.9|-53.0|1.000
71137798|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|-15.6||||1|TWO_SIDED|95.0|-69.4|38.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||38.3|-69.4|1.000
71137799|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|-27.8||||0.58|TWO_SIDED|95.0|-71.9|16.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||16.3|-71.9|0.580
71137800|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|5.6||||1|TWO_SIDED|95.0|-41.9|53.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||53.0|-41.9|1.000
71137801|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|-24.4||||0.58|TWO_SIDED|95.0|-72.2|23.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||23.3|-72.2|0.580
71137802|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|-44.4||||0.103|TWO_SIDED|95.0|-76.9|-12.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||-12.0|-76.9|0.103
71137803|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|5.6||||1|TWO_SIDED|95.0|-41.9|53.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||53.0|-41.9|1.000
71137804|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|-4.4||||1|TWO_SIDED|95.0|-58.3|49.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||49.4|-58.3|1.000
71137805|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-48.7|48.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||48.7|-48.7|1.000
71137806|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|16.7||||0.637|TWO_SIDED|95.0|-29.7|63.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||63.0|-29.7|0.637
71137807|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-60.0|33.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||33.3|-60.0|1.000
71137808|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|18.6||||0.57|TWO_SIDED|95.0|-29.4|66.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||66.6|-29.4|0.570
71137809|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|-14.8||||0.33|TWO_SIDED|95.0|-39.7|10.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||10.2|-39.7|0.330
71137810|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|-10.3||||1|TWO_SIDED|95.0|-40.0|19.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||19.4|-40.0|1.000
71137811|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|18.6||||0.57|TWO_SIDED|95.0|-29.4|66.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||66.6|-29.4|0.570
71137812|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|-14.8||||0.33|TWO_SIDED|95.0|-39.7|10.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||10.2|-39.7|0.330
71137813|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|0.8||||1|TWO_SIDED|95.0|-33.8|35.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||35.4|-33.8|1.000
70863999|NCT00785928|141213614|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value for IgM. Pairwise comparison (2-sided) of 30 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.023
71137814|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|-1.4||||1|TWO_SIDED|95.0|-42.6|39.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||39.7|-42.6|1.000
70864000|NCT00785928|141213614|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value for IgM. Pairwise comparison (2-sided) of 60 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.004
71137815|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|-21.4||||0.1|TWO_SIDED|95.0|-42.9|0.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||0.1|-42.9|0.100
71137816|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|0.8||||1|TWO_SIDED|95.0|-33.8|35.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||35.4|-33.8|1.000
71137817|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|5.7||||1|TWO_SIDED|95.0|-33.8|45.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||45.3|-33.8|1.000
70864001|NCT00785928|141213614|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value for IgM. Pairwise comparison (2-sided) of 120 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.017
70864002|NCT00785928|141213614|SUPERIORITY_OR_OTHER|||||||0.944||95.0||||P-value for IgA. Pairwise comparison (2-sided) of 1 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.944
70864003|NCT00785928|141213614|SUPERIORITY_OR_OTHER|||||||0.677||95.0||||P-value for IgA. Pairwise comparison (2-sided) of 3 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.677
70864004|NCT00785928|141213614|SUPERIORITY_OR_OTHER|||||||0.053||95.0||||P-value for IgA. Pairwise comparison (2-sided) of 10 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.053
70864005|NCT00785928|141213614|SUPERIORITY_OR_OTHER|||||||0.061||95.0||||P-value for IgA. Pairwise comparison (2-sided) of 30 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.061
70864006|NCT00785928|141213614|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||P-value for IgA. Pairwise comparison (2-sided) of 60 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.025
70864007|NCT00785928|141213614|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-value for IgA. Pairwise comparison (2-sided) of 120 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.030
70864008|NCT00570765|141213626|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Treatment arms compared using 2-sided Wilcoxon-Mann-Whitney test at 5% significance level. Treatment groups were pairwise compared versus placebo.||Hierarchical testing strategy was proposed to account for multiple comparisons. Statistical significance was evaluated as follows: if statistical significance at alpha=0.05 is shown for the 10 mg OCA versus placebo, then the statistical significance at alpha=0.05 for the 50 mg OCA versus placebo was evaluated. If no statistical significance was shown at alpha=0.05 at the first step, then the subsequent comparison was not considered statistically significant.||||<0.0001
71137818|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|-7.6||||0.598|TWO_SIDED|95.0|-29.9|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||14.6|-29.9|0.598
71137819|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|-3.2||||1|TWO_SIDED|95.0|-30.7|24.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||24.3|-30.7|1.000
70864009|NCT00570765|141213627|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Treatment arms compared using 2-sided Wilcoxon-Mann-Whitney test at 5% significance level. Treatment groups were pairwise compared versus placebo.||||||<0.0001
70864010|NCT00570765|141213628|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|Tx arms will be compared using the 2-sided Wilcoxon-Mann-Whitney test, at 5% significance level. Tx groups will be pairwise compared vs. placebo.||||||<0.01
70864011|NCT03387683|141213641|OTHER||Difference in LSM|0.31121|STANDARD_ERROR_OF_MEAN|0.46184||0.504|TWO_SIDED|95.0|-0.619|1.24141||Statistical significance was inferred at a (2-sided) 0.05 level.|ANCOVA|The LSM estimate and corresponding p-value were obtained from a linear model with treatment and baseline value of the endpoint as covariates.||Difference in LSM (Placebo-Dapagliflozin 10 mg)||1.24141|-0.61900|0.504
70864012|NCT03387683|141213642|OTHER||Difference in LSM|1.74969|STANDARD_ERROR_OF_MEAN|2.18363||0.427|TWO_SIDED|95.0|-2.64837|6.14775||Statistical significance was inferred at a (2-sided) 0.05 level.|ANCOVA|The LSM estimate and corresponding p-value were obtained from a linear model with treatment and baseline value of the endpoint as covariates.||Difference in LSM (Placebo - Dapagliflozin 10 mg)||6.14775|-2.64837|0.427
70864013|NCT02083081|141213689|SUPERIORITY|||||||0.38|||||||generalized estimating equations (GEE)|||||||0.38
70864014|NCT02083081|141213690|SUPERIORITY|||||||0.45|||||||generalized estimating equations (GEE)|||||||0.45
70864015|NCT02083081|141213691|SUPERIORITY|||||||0.96|||||||generalized estimating equations (GEE)|||||||0.96
70864016|NCT01104155|141213751|SUPERIORITY_OR_OTHER_LEGACY|||||||0.204|||||||1-sided exact binomial|Based on a one-sided exact binomial test compared to 9%.||||||0.204
70864017|NCT01104155|141213751|SUPERIORITY_OR_OTHER_LEGACY|||||||0.041|||||||1-sided exact binomial|||||||0.041
70864018|NCT01484132|141213756|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||t-test, 2 sided|||One sample t-test was used to test whether the mean change from baseline to 6 months was different from 0.||||0.58
70954429|NCT06612255|141411520|OTHER|Ratio (%) of adjusted geometric means with comparison presented as test (powder)/reference (tablet).|Fixed Effect Analysis|51.68|||||TWO_SIDED|90.0|45.71|58.43||||||Results obtained from mixed effects model of natural log transformed pharmacokinetic parameters including terms for regimen, period and sequence fitted as fixed effects and subject nested within sequence fitted as a random effect.||58.43|45.71|
70864019|NCT01484132|141213756|SUPERIORITY_OR_OTHER||Slope|-0.061||||0.406|TWO_SIDED|95.0|-0.206|0.084||P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 6 months after adjusting for covariates.|Regression, Linear|Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on all surfaces and change in BPA from baseline to 6 months, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.||0.084|-0.206|0.406
70864020|NCT01484132|141213756|SUPERIORITY_OR_OTHER||Slope|-0.017||||0.693|TWO_SIDED|95.0|-0.101|0.067||P-value is to test the longitudinal association between composite exposure on all surfaces and change in BPA after adjusting for covariates.|Mixed Models Analysis|Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.||To see the longitudinal association between composite exposure on all surfaces and change in BPA from baseline, the repeated measure model was used with all available follow-up BPA data. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.||0.067|-0.101|0.693
70864021|NCT01484132|141213756|SUPERIORITY_OR_OTHER||Slope|-0.123||||0.16|TWO_SIDED|95.0|-0.296|0.05||P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 6 months after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 6 months, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.||0.050|-0.296|0.160
70864022|NCT01484132|141213756|SUPERIORITY_OR_OTHER||Slope|-0.029||||0.574|TWO_SIDED|95.0|-0.131|0.073||P-value is to test the longitudinal association between composite exposure on posterior occlusal surfaces and change in BPA after adjusting for covariates.|Mixed Models Analysis|Baseline BPA, season, household income, and canned food were used as covariates.||To see the longitudinal association between composite exposure on posterior occlusal surfaces and change in BPA from baseline, the repeated measure model was used with all available follow-up BPA data. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.||0.073|-0.131|0.574
70864023|NCT01484132|141213757|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||t-test, 2 sided|||One sample t-test was used to test whether the mean change from baseline was different from 0.||||0.11
70864024|NCT01484132|141213757|SUPERIORITY_OR_OTHER||Slope|0.299||||0.003|TWO_SIDED|95.0|0.105|0.494||P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 1 day after the first treatment after adjusting for covariates.|Regression, Linear|Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on all surfaces and change in BPA from baseline to 1 day after the first treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.||0.494|0.105|0.003
70864025|NCT01484132|141213757|SUPERIORITY_OR_OTHER||Slope|0.365||||0.002|TWO_SIDED|95.0|0.145|0.585||P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 1 day after the first treatment after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 1 day after the first treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.||0.585|0.145|0.002
70864026|NCT01484132|141213758|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||t-test, 2 sided|||One sample t-test was used to test whether the mean change from baseline was different from 0.||||0.27
70864027|NCT01484132|141213758|SUPERIORITY_OR_OTHER||Slope|-0.068||||0.48|TWO_SIDED|95.0|-0.258|0.123||P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 14 days after the first treatment after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on all surfaces and change in BPA from baseline to 14 days after the first treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.||0.123|-0.258|0.480
70864028|NCT01484132|141213758|SUPERIORITY_OR_OTHER||Slope|-0.074||||0.501|TWO_SIDED|95.0|-0.293|0.145||P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 14 days after the first treatment after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 14 days after the first treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.||0.145|-0.293|0.501
71137820|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|12.9||||0.468|TWO_SIDED|95.0|-24.7|50.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared|||Non-responders, Week 52|Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|50.4|-24.7|0.468
70864029|NCT01484132|141213759|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||t-test, 2 sided|||One sample t-test was used to test whether the mean change from baseline was different from 0.||||0.41
70864030|NCT01484132|141213759|SUPERIORITY_OR_OTHER||Slope|-0.082||||0.612|TWO_SIDED|95.0|-0.418|0.254||P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 1 day after the second treatment after adjusting for covariates.|Regression, Linear|Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on all surfaces and change in BPA from baseline to 1 day after the second treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.||0.254|-0.418|0.612
70864031|NCT01484132|141213759|SUPERIORITY_OR_OTHER||Slope|0.078||||0.696|TWO_SIDED|95.0|-0.339|0.495||P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 1 day after the second treatment after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 1 day after the second treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.||0.495|-0.339|0.696
70864032|NCT01484132|141213760|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||t-test, 2 sided|||One sample t-test was used to test whether the mean change from baseline was different from 0.||||0.76
70864033|NCT01484132|141213760|SUPERIORITY_OR_OTHER||Slope|-0.018||||0.968|TWO_SIDED|95.0|-1.061|1.025||P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 14 days after the second treatment after adjusting for covariates.|Regression, Linear|Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on all surfaces and change in BPA from baseline to 14 days after the second treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.||1.025|-1.061|0.968
70864034|NCT01484132|141213760|SUPERIORITY_OR_OTHER||Slope|-0.083||||0.822|TWO_SIDED|95.0|-0.941|0.775||P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 14 days after the second treatment after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 14 days after the second treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.||0.775|-0.941|0.822
70864035|NCT02080637|141213836|OTHER||Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|0.5||0.01|TWO_SIDED||||||Paired t-test|||Baseline versus 2 hours post-ambrisentan||||0.01
70864036|NCT02080637|141213837|OTHER||Slope|-27.0||||0.94|TWO_SIDED|95.0|-775.0|723.0|||Regression, Linear|||||723|-775|0.94
70864037|NCT02080637|141213838|OTHER||Slope|1.2||||0.61|TWO_SIDED|95.0|-3.9|6.3|||Regression, Linear|||||6.3|-3.9|0.61
70864038|NCT02770170|141213839|OTHER|||||||0.7271||||||An alpha of 0.20 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod quadratic model fit|||Multiple comparison procedures and modelling (MCPmod) techniques for logistic regression was used.||||0.7271
71137821|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|6.2||||1|TWO_SIDED|95.0|-15.7|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||28.1|-15.7|1.000
70864039|NCT02770170|141213839|OTHER|||||||0.6415||||||An alpha of 0.20 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod sigmoidal Emax model fit|||Multiple comparison procedures and modelling (MCPmod) techniques for logistic regression was used.||||0.6415
70864040|NCT02770170|141213839|OTHER|||||||0.7367||||||An alpha of 0.20 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod Emax model fit|||Multiple comparison procedures and modelling (MCPmod) techniques for logistic regression was used.||||0.7367
70864041|NCT02770170|141213839|OTHER|||||||0.6624||||||An alpha of 0.20 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod exponential model fit|||Multiple comparison procedures and modelling (MCPmod) techniques for logistic regression was used.||||0.6624
70864042|NCT02770170|141213839|OTHER||Risk Difference (RD)|-10.0||||0.4645|TWO_SIDED|80.0|-27.292|7.288|||Regression, Logistic|include treatment and covariates, race (Asian or non-Asian), proteinuria at screening (\<3g/day or \>= 3g/day)|Confidence intervals calculated using delta method|||7.288|-27.292|0.4645
70864043|NCT02770170|141213839|OTHER||Risk Difference (RD)|-3.38||||0.8084|TWO_SIDED|80.0|-21.204|14.451|||Regression, Logistic|include treatment and covariates, race (Asian or non-Asian), proteinuria at screening (\<3g/day or \>= 3g/day)|Confidence intervals calculated using delta method|||14.451|-21.204|0.8084
70864044|NCT02770170|141213839|OTHER||Risk Difference (RD)|-3.77||||0.7398|TWO_SIDED|80.0|-18.364|10.832|||Regression, Logistic|include treatment and covariates, race (Asian or non-Asian), proteinuria at screening (\<3g/day or \>= 3g/day)|Confidence intervals calculated using delta method|||10.832|-18.364|0.7398
71137822|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|15.1||||0.538|TWO_SIDED|95.0|-15.2|45.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||45.4|-15.2|0.538
70864045|NCT02770170|141213840|OTHER||Risk Difference (RD)|-8.93||||0.5773|TWO_SIDED|80.0|-23.66|7.64|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||7.64|-23.66|0.5773
70864046|NCT02770170|141213840|OTHER||Risk Difference (RD)|12.5||||0.4013|TWO_SIDED|80.0|-4.59|29.03|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||29.03|-4.59|0.4013
70864047|NCT02770170|141213840|OTHER||Risk Difference (RD)|-2.5||||0.8965|TWO_SIDED|80.0|-15.98|11.1|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||11.10|-15.98|0.8965
70864048|NCT02770170|141213841|OTHER||Risk Difference (RD)|-19.64||||0.1476|TWO_SIDED|80.0|-35.38|-2.48|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||-2.48|-35.38|0.1476
70864049|NCT02770170|141213841|OTHER||Risk Difference (RD)|12.5||||0.4013|TWO_SIDED|80.0|-4.2|26.86|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||26.86|-4.20|0.4013
70864050|NCT02770170|141213841|OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|80.0|-13.63|13.63|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||13.63|-13.63|
70864051|NCT02770170|141213842|OTHER||Risk Difference (RD)|-26.67||||0.0512|TWO_SIDED|80.0|-41.52|-9.42|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||-9.42|-41.52|0.0512
70864052|NCT02770170|141213842|OTHER||Risk Difference (RD)|5.0||||0.7597|TWO_SIDED|80.0|-12.1|20.74|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||20.74|-12.10|0.7597
70864053|NCT02770170|141213842|OTHER||Risk Difference (RD)|-5.0||||0.7505|TWO_SIDED|80.0|-18.74|9.02|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||9.02|-18.74|0.7505
70864054|NCT02770170|141213843|OTHER||Risk Difference (RD)|-21.43||||0.1269|TWO_SIDED|80.0|-36.03|-4.41|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||-4.41|-36.03|0.1269
70864055|NCT02770170|141213843|OTHER||Risk Difference (RD)|5.0||||0.7889|TWO_SIDED|80.0|-12.24|21.62|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||21.62|-12.24|0.7889
70864056|NCT02770170|141213843|OTHER||Risk Difference (RD)|-12.5||||0.2906|TWO_SIDED|80.0|-25.99|1.68|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||1.68|-25.99|0.2906
70864057|NCT02770170|141213844|OTHER||Risk Difference (RD)|-9.64||||0.5687|TWO_SIDED|80.0|-25.79|7.45|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||7.45|-25.79|0.5687
70864058|NCT02770170|141213844|OTHER||Risk Difference (RD)|2.5||||0.9217|TWO_SIDED|80.0|-14.67|19.17|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||19.17|-14.67|0.9217
70864059|NCT02770170|141213844|OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|80.0|-14.03|14.03|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||14.03|-14.03|
70864060|NCT02979197|141213865|NON_INFERIORITY|A two-sample t-test was used to test the one-sided hypothesis that treatment with Amlodipine+Celecoxib (arm 1) was non-inferior to half of the effect achieved with Amlodipine+Placebo (arm 2). The primary efficacy endpoint was considered met if the lower limits of the 97.5% one-side confidence interval (CI) for the difference in SBPday change in arm 1 and 50% of the mean change in arm 2 was less than 0.||||||0.024|||||||t-test, 2 sided|||LOCF method was used. Primary efficacy analysis was based on the difference between the Amlodipine+Celecoxib and Amlodipine+Placebo (arms 1 and 2, respectively) in the mean change in SBPday from Baseline to final (Day 13), where a subject completed the 14-day treatment plan, or to Day 6, where a subject was withdrawn from treatment before the Day 13 dose but after the Day 6 dose, or to baseline, where a subject was withdrawn before the Day 6 dose.||||0.024
70864061|NCT02979197|141213866|OTHER|ANOVA F-test was used to compare the mean changes in body weight from baseline to end of treatment among the three treatment arms. The omni-bus test was to conclude if any differences existed.||||||0.006|||||||ANOVA|||A serial gatekeeping strategy was used for secondary efficacy analyses. If, and only if, statistical significance was achieved for the primary endpoint (SBPday), a secondary hierarchical analysis was to be used to evaluate secondary efficacy endpoints and was only to proceed from one to the next if the alpha was met for the prior; if the alpha was not met, analysis was performed for informational purposes only. Mean change in body weight was the 1st of the four secondary efficacy endpoints.||||0.006
70864062|NCT02979197|141213867|SUPERIORITY|A two-sample t-test for superiority was used to test the one-sided hypothesis that treatment with Amlodipine+Celecoxib lowered SBP24h to a greater degree than Amlodipine+Placebo.||||||0.826|||||||t-test, 2 sided|||A serial gatekeeping strategy was used for secondary efficacy analyses. If, and only if, statistical significance was achieved for the primary endpoint (SBPday), a secondary hierarchical analysis was to be used to evaluate secondary efficacy endpoints and was only to proceed from one to the next if the alpha was met for the prior; if the alpha was not met, analysis was performed for informational purposes only. Mean change in SBP24h was the 2nd of the four secondary efficacy endpoints.||||0.826
71137823|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|-11.2||||0.692|TWO_SIDED|95.0|-48.0|25.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||25.6|-48.0|0.692
70864063|NCT02979197|141213868|SUPERIORITY|A two-sample t-test for superiority was used to test the one-sided hypothesis that treatment with Amlodipine+Celecoxib lowered DBP24h to a greater degree than Amlodipine+Placebo.||||||0.5|||||||t-test, 2 sided|||A serial gatekeeping strategy was used for secondary efficacy analyses. If, and only if, statistical significance was achieved for the primary endpoint (SBPday), a secondary hierarchical analysis was to be used to evaluate secondary efficacy endpoints and was only to proceed from one to the next if the alpha was met for the prior; if the alpha was not met, analysis was performed for informational purposes only. Mean change in DBP24h was the 3rd of the 4 secondary efficacy endpoints.||||0.500
71137824|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|-14.5||||0.388|TWO_SIDED|95.0|-46.9|17.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||17.9|-46.9|0.388
71137825|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|-19.0||||0.418|TWO_SIDED|95.0|-54.8|16.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||16.9|-54.8|0.418
71137826|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|-17.1||||0.448|TWO_SIDED|95.0|-54.1|20.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||20.0|-54.1|0.448
71137827|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|-13.7||||0.43|TWO_SIDED|95.0|-47.4|19.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||19.9|-47.4|0.430
71137828|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|-2.6||||1|TWO_SIDED|95.0|-42.8|37.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||37.6|-42.8|1.000
71137829|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|-21.2||||0.406|TWO_SIDED|95.0|-55.3|12.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||12.9|-55.3|0.406
71137830|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|-14.5||||0.388|TWO_SIDED|95.0|-46.9|17.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||17.9|-46.9|0.388
71137831|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|-7.8||||1|TWO_SIDED|95.0|-46.5|30.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||30.8|-46.5|1.000
71137832|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|-25.3||||0.204|TWO_SIDED|95.0|-54.7|4.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||4.1|-54.7|0.204
70954433|NCT03547739|141411658|SUPERIORITY||Risk Ratio (RR)|4.22|||<|0.001|TWO_SIDED|95.0|2.88|6.18|||Chi-squared||Generalized Estimating Equation model with robust standard errors used. Risk Ratios reported were adjusted for baseline education level, wealth index, length of couple relationship, previous couple testing at baseline, and couple age disparity.|Home visits as compared to Standard Care||6.18|2.88|<0.001
71137833|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|-2.0||||0.907|TWO_SIDED|95.0|-34.9|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||31.0|-34.9|0.907
71137834|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|-2.0||||1|TWO_SIDED|95.0|-40.2|36.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||36.3|-40.2|1.000
71137835|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|6.5||||1|TWO_SIDED|95.0|-28.4|41.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||41.3|-28.4|1.000
71137836|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|16.5||||0.45|TWO_SIDED|95.0|-15.5|48.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||48.4|-15.5|0.450
71137837|NCT02365649|141776321|SUPERIORITY||Risk Difference (RD)|9.8||||0.661|TWO_SIDED|95.0|-27.0|46.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||46.6|-27.0|0.661
71137838|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-77.5|77.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||77.5|-77.5|1.000
71137839|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|25.0||||0.608|TWO_SIDED|95.0|-20.8|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||70.8|-20.8|0.608
71137840|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|-50.0||||0.105|TWO_SIDED|95.0|-84.6|-15.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||-15.4|-84.6|0.105
70954434|NCT03547739|141411658|SUPERIORITY||Risk Ratio (RR)|3.69|||<|0.001|TWO_SIDED|95.0|2.5|5.45|||Chi-squared||Generalized Estimating Equation model with robust standard errors used. Risk Ratios reported were adjusted for baseline education level, wealth index, length of couple relationship, previous couple testing at baseline, and couple age disparity.|HIV Self-testing as compared to Standard Care||5.45|2.50|<0.001
71137841|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-77.5|77.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||77.5|-77.5|1.000
70864064|NCT02979197|141213869|SUPERIORITY|A two-sample t-test for superiority was used to test the one-sided hypothesis that treatment with Amlodipine+Celecoxib improved creatinine clearance to a greater degree than Amlodipine+Placebo.||||||0.668|||||||t-test, 2 sided|||A serial gatekeeping strategy was used for secondary efficacy analyses. If, and only if, statistical significance was achieved for the primary endpoint (SBPday), a secondary hierarchical analysis was to be used to evaluate secondary efficacy endpoints and was only to proceed from one to the next if the alpha was met for the prior; if the alpha was not met, analysis was performed for informational purposes only. Mean change in creatinine clearance was the 4th of 4 secondary efficacy endpoints.||||0.668
70864065|NCT02979197|141213870|SUPERIORITY|Differences in the occurrence of TEAEs between treatment arms were evaluated using Chi-square test.||||||0.675|||||||Chi-squared|Computed on the number of subjects who had at least one TEAE.||||||0.675
70864066|NCT02979197|141213870|SUPERIORITY|||||||0.555|||||||Regression, Logistic|TEAE (1=at least one TEAE occurred for the subject; 0=otherwise) as dependent variable and treatment as fixed effect.||||||0.555
70864067|NCT02979197|141213871|SUPERIORITY|||||||0.226|||||||t-test, 2 sided|||For this analysis, all values below the limit of quantification were treated as 0.||||0.226
70864068|NCT02979197|141213872|SUPERIORITY|||||||0.215|||||||t-test, 2 sided|||For this analysis, all values below the limit of quantification (BLQ) were treated as 0.04 ng/mL. Assignment of BLQ values to a nonzero number allowed computation of the log transformation. The selection of 0.04 ng/mL was based on the lower limit of quantification of the validated bioanalytical method (0.05 ng/mL) and selecting the next lowest number at the hundredth decimal place.||||0.215
70864069|NCT02979197|141213873|SUPERIORITY|||||||0.0005|||||||ANCOVA|Adjusted mean = -3.48 μmol/L; 95% confidence interval = -5.4 to -1.6||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the Amlodipine+Celecoxib arm from baseline to Day 14.||||0.0005
70864070|NCT02979197|141213873|SUPERIORITY|||||||0.075|||||||ANCOVA|Adjusted mean = -1.72 μmol/L; 95% confidence interval = -3.6 to 0.2||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the Amlodipine+Placebo arm from baseline to Day 14.||||0.0750
70864071|NCT02979197|141213873|SUPERIORITY|||||||0.4184|||||||ANCOVA|Adjusted mean = -1.92 μmol/L; 95% confidence interval = -6.6 to 2.8||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the Placebo+Placebo arm from baseline to Day 14.||||0.4184
70864072|NCT02979197|141213873|SUPERIORITY|||||||0.2022|||||||ANCOVA|Adjusted mean = -1.76 μmol/L; 95% confidence interval = -4.5 to 1.0||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the comparison between the Amlodipine+Celecoxib and Amlodipine+Placebo arms.||||0.2022
70864073|NCT02979197|141213873|SUPERIORITY|||||||0.541|||||||ANCOVA|Adjusted mean = -1.56 μmol/L; 95% confidence interval = -6.6 to 3.5||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the comparison between the Amlodipine+Celecoxib and Placebo+Placebo arms.||||0.5410
70864074|NCT02979197|141213873|SUPERIORITY|||||||0.9397|||||||ANCOVA|Adjusted mean = 0.19 μmol/L; 95% confidence interval = -4.9 to 5.2||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the comparison between the Amlodipine+Placebo and Placebo+Placebo arms.||||0.9397
70864075|NCT03467048|141213876|NON_INFERIORITY|Null hypothesis: McGrath Video Laryngoscopy is non-inferior to Macintosh direct laryngoscopy.|Odds Ratio (OR)|4.65|||<|0.01|TWO_SIDED|95.0|2.22|9.75|||t-test, 1 sided|||||9.75|2.22|<0.01
70864076|NCT03467048|141213877|NON_INFERIORITY|Null hypothesis: McGrath videolaryngoscopy is non-inferior to Direct laryngoscopy|Odds Ratio (OR)|0.3||||0.08|TWO_SIDED|0.975|0.04|2.28|||t-test, 1 sided|||||2.28|0.04|0.08
70864077|NCT03467048|141213878|NON_INFERIORITY|Null hypothesis: McGrath videolaryngoscopy is non-inferior to Direct laryngoscopy|Odds Ratio (OR)|0.87||||0.41|TWO_SIDED|97.5|0.1|7.77|||t-test, 1 sided|||||7.77|0.1|0.41
70864078|NCT01898208|141213879|SUPERIORITY_OR_OTHER|||||||0.92|TWO_SIDED||||||Kruskal-Wallis|||For Vancomycin, all patients||||0.92
70864079|NCT01898208|141213879|SUPERIORITY_OR_OTHER|||||||0.032|TWO_SIDED||||||Kruskal-Wallis|||For vancomycin, organisms not requiring vancomycin.||||0.032
70864080|NCT01898208|141213879|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||Kruskal-Wallis|||For vancomycin-susceptible enterococci||||0.037
70864081|NCT01898208|141213879|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Kruskal-Wallis|||For vancomycin, methicillin-susceptible Staphylococcus aureus.||||0.2
70864082|NCT01898208|141213879|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||Kruskal-Wallis|||For nafcillin, oxacillin, or cefazolin.||||0.035
70864083|NCT01898208|141213879|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Kruskal-Wallis|||For piperacillin-tazobactam.||||0.012
70864084|NCT01898208|141213879|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||Kruskal-Wallis|||For cefepime.||||0.56
70864085|NCT01898208|141213880|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||Kruskal-Wallis|||This analysis compares the 3 groups.||||0.55
70864086|NCT01898208|141213881|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Kruskal-Wallis|||For time to first appropriate de-escalation comparing the 3 groups.||||<0.0001
70864087|NCT01898208|141213881|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Kruskal-Wallis|||For time to first appropriate escalation comparing the 3 groups.||||0.04
70864088|NCT01898208|141213882|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||Chi-squared|||This analysis compares the 3 groups.||||0.015
70864089|NCT01898208|141213883|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Kruskal-Wallis|||This analysis compares the FilmArray test to control arm.||||<0.0001
70864090|NCT01898208|141213883|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Kruskal-Wallis|||This analysis compares FilmArray plus antimicrobial stewardship to the control arm.||||<0.0001
70864091|NCT01898208|141213884|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||Kruskal-Wallis|||This analysis is to compare the three groups.||||0.79
70864092|NCT01898208|141213885|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Kruskal-Wallis|||||||0.90
70864093|NCT01898208|141213886|SUPERIORITY_OR_OTHER|||||||0.62|TWO_SIDED||||||Chi-squared|||This analysis is a comparison of the 3 groups.||||0.62
70864094|NCT01898208|141213887|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Kruskal-Wallis|||This analysis compares the three groups.||||0.60
70864095|NCT01898208|141213888|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||Fisher Exact|||Comparison of the 3 groups for all-cause mortality.||||0.74
70864096|NCT01898208|141213888|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED||||||Fisher Exact|||Comparison of the 3 groups for attributable mortality.||||0.42
70864097|NCT01898208|141213889|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||Fisher Exact|||This analysis is a comparison across all three groups.||||0.82
70864098|NCT01898208|141213891|SUPERIORITY_OR_OTHER|||||||0.7789|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the 3 arms for total hospitalization costs.||||0.7789
70864099|NCT01898208|141213891|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the 3 arms for laboratory test cost.||||0.0006
70864100|NCT01898208|141213891|SUPERIORITY_OR_OTHER|||||||0.654|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the 3 arms for antimicrobials costs.||||0.6540
70864101|NCT02436681|141213894|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
70864102|NCT02436681|141213896|SUPERIORITY||||||=|0.0468|||||||t-test, 1 sided|||||||= 0.0468
70864103|NCT02436681|141213898|SUPERIORITY||||||=|0.014|||||||t-test, 1 sided|||||||=0.014
70864104|NCT02436681|141213899|SUPERIORITY||||||=|0.018|||||||t-test, 1 sided|||||||= 0.018
71137842|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-49.0|49.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||49.0|-49.0|1.000
71137843|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|-30.0||||0.565|TWO_SIDED|95.0|-79.3|19.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|ANOVA||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||19.3|-79.3|0.565
71137844|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|50.0||||0.467|TWO_SIDED|95.0|15.4|84.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||84.6|15.4|0.467
71137845|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-49.0|49.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||49.0|-49.0|1.000
71137846|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|-50.0||||0.105|TWO_SIDED|95.0|-84.6|-15.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||-15.4|-84.6|0.105
71137847|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-64.5|89.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||89.5|-64.5|1.000
71137848|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-35.7|60.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||60.7|-35.7|1.000
71137849|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|-17.5||||1|TWO_SIDED|95.0|-66.0|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||31.0|-66.0|1.000
71137850|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|50.0||||0.467|TWO_SIDED|95.0|15.4|84.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||84.6|15.4|0.467
71137851|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-35.7|60.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||60.7|-35.7|1.000
70864105|NCT01599832|141213911|OTHER|||||||0.083||||||P-value was from test of significance of log-transformed baseline K\^trans.|Regression, Cox|Multivariate model with adjustment for prior treatment, and clinical prognostic index (good/intermediate/poor) (n=16 had complete data)||||||0.083
70864106|NCT01739361|141213928|SUPERIORITY_OR_OTHER|||||||0.353|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.353
70864107|NCT02443519|141213931|SUPERIORITY||Slope|1.6||||0.027|TWO_SIDED|95.0|-0.7|3.9||Significance threshold set a priori at .025 to adjust for two co-primary outcomes.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A positive slope indicates greater reduction in the proportino of people with Severe MIDAS scores (Score \>=21) in the MBCT-M group vs. the WL/TAU group.|||3.9|-0.7|.027
70864108|NCT02443519|141213932|SUPERIORITY||Slope|14.1|||<|0.004|TWO_SIDED|95.0|0.8|21.8||Significance threshold set a priori at .025 to account for two co-primary outcomes.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|Positive slope indicated larger reductions in HDI in the MBCT-M group compared to the WL/TAU group.|||21.8|0.8|<.004
70864109|NCT02443519|141213933|SUPERIORITY||Slope|-0.05||||0.773|TWO_SIDED|95.0|-3.7|2.8||Threshold for statistical significance set a priori at .05.|Mixed Models Analysis|Key test was the Treatment (MBCT-M vs. WL/TAU) X Time (Month 1 vs. 4) interaction with Treatment and Time in the model|A positive slope indicates greater reduction in headache days in the MBCT-M group vs. the WL/TAU group.|||2.8|-3.7|.773
70864110|NCT02443519|141213934|SUPERIORITY||Slope|0.01||||0.888|TWO_SIDED|95.0|-0.14|0.16||Threshold for significance set a priori at .05.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A positive slope indicates a greater reduction in headache attack pain intensity in the MBCT-M group vs. WL/TAU.|||0.16|-0.14|.888
70864111|NCT02443519|141213935|SUPERIORITY||Slope|7.45||||0.035|TWO_SIDED|95.0|2.48|12.42|||Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A positive slope indicates a greater reduction in Pain Catastrophizing Scale in the MBCT-M group vs. WL/TAU.|||12.42|2.48|.035
70864112|NCT02443519|141213936|SUPERIORITY||Slope|-3.05||||0.572|TWO_SIDED|95.0|-10.83|4.74|||Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A negative slope indicates a greater improvement in Chronic Pain Acceptance in the MBCT-M group vs. WL/TAU.|||4.74|-10.83|.572
70864113|NCT02443519|141213937|SUPERIORITY||Slope|-2.65||||0.609|TWO_SIDED|95.0|-11.76|6.46||Threshold for significance set a priori at .05.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A negative slope indicates a smaller decrease in the Five Factor Mindfulness Questionnaire in the MBCT-M group vs. WL/TAU.|||6.46|-11.76|.609
70864114|NCT02443519|141213938|SUPERIORITY||Slope|8.45||||0.022|TWO_SIDED|95.0|2.99|13.91||Threshold for significance set a priori at .05.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A positive slope indicates a greater reduction in Headache Specific Locus of Control Scale score in the MBCT-M group vs. WL/TAU.|||13.91|2.99|.022
70864115|NCT02443519|141213939|SUPERIORITY||Slope|-2.01||||0.124|TWO_SIDED|95.0|-7.56|3.53||Threshold for significance set a priori at .05.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A negative slope indicates a greater improvement in Headache Management Self-Efficacy Scale score in the MBCT-M group vs. WL/TAU.|||3.53|-7.56|.124
70864116|NCT02443519|141213940|SUPERIORITY||Slope|3.48||||0.017|TWO_SIDED|95.0|0.63|6.33||Threshold for significance set a priori at .05.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A positive slope indicates a greater reduction in PROMIS-Depression score in the MBCT-M group vs. WL/TAU.|||6.33|0.63|.017
70864117|NCT02443519|141213941|SUPERIORITY||Slope|2.82||||0.259|TWO_SIDED|95.0|-0.03|5.68||Threshold for significance set a priori at .05.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A positive slope indicates a greater reduction in PROMIS-Anxiety score in the MBCT-M group vs. WL/TAU.|||5.68|-0.03|.259
70864118|NCT02443519|141213942|SUPERIORITY||Slope|-1.0||||0.007|TWO_SIDED|95.0|-1.6|-0.3|||Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL/TAU) X Time (Month 1 vs. 4) interaction with both Treatment and Time in the model.|A negative slope indicated a larger decrease in MIDI scores in the MBCT-M group vs. WL/TAU|||-0.3|-1.6|.007
70864119|NCT00932737|141213943|OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.29||0.0156|TWO_SIDED|95.0|-1.3|-0.1|||Mixed effect model||The adjusted mean difference between Hyoscine butylbromide minus Placebo was calculated.|A model included fixed, categorical effects of treatment group, episode, interval and center, as well as the treatment-by-episode interaction, with the covariate of baseline intensity of Abdominal pain associated with cramping . An unstructured covariance structure was used to model the within-patient errors.||-0.1|-1.3|0.0156
70864120|NCT00932737|141213944|OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.0512|TWO_SIDED|95.0|-1.2|0.0|||Mixed effect model||The adjusted mean difference between Hyoscine butylbromide minus Placebo was calculated.|A model included fixed, categorical effects of treatment group, episode, interval and center, as well as the treatment-by-episode interaction, with the covariate of baseline intensity of Abdominal pain associated with cramping . An unstructured covariance structure was used to model the within-patient errors.||0.0|-1.2|0.0512
70864121|NCT00932737|141213945|OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.32||0.0351|TWO_SIDED|95.0|-1.3|0.0|||ANCOVA||The adjusted mean difference between Hyoscine butylbromide minus Placebo was calculated.|The analysis of covariance (ANCOVA) was performed on the change from baseline to the last recorded rating of intensity for each treated episode of Abdominal pain associated with cramping (APC). The statistical model included the main effects of treatment, episode, and center as well as terms for the treatment-by-episode interaction, with baseline intensity of APC for the respective episode as a covariate.||0.0|-1.3|0.0351
70864122|NCT00932737|141213946|OTHER||Adjusted mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.35||0.3557|TWO_SIDED|95.0|-1.0|0.4|||ANCOVA||The adjusted mean difference between Hyoscine butylbromide and Placebo was calculated.|The analysis of covariance (ANCOVA) was performed on the change from baseline to the last recorded rating of intensity for each treated episode of Abdominal pain associated with cramping (APC). The statistical model included the main effects of treatment, episode, and center as well as terms for the treatment-by-episode interaction, with baseline intensity of APC for the respective episode as a covariate.||0.4|-1.0|0.3557
70864123|NCT00932737|141213947|OTHER||Odds Ratio (OR)|1.071||||0.831|TWO_SIDED|95.0|0.572|2.004|||Regression, Logistic|Logistic regression included the main effects of treatment group, episode, and center.||||2.004|0.572|0.831
70864124|NCT00932737|141213948|OTHER||Odds Ratio (OR)|1.222||||0.557|TWO_SIDED|95.0|0.626|2.387|||Regression, Logistic|Logistic regression included the main effects of treatment group, episode, and center.||||2.387|0.626|0.557
70864125|NCT00932737|141213949|OTHER||Odds Ratio (OR)|0.737||||0.396|TWO_SIDED|95.0|0.365|1.49|||Regression, Logistic|Logistic regression included the main effects of treatment group, episode, and center.||||1.490|0.365|0.396
70864126|NCT00932737|141213950|OTHER||Odds Ratio (OR)|1.336||||0.448|TWO_SIDED|95.0|0.632|2.827|||Regression, Logistic|Logistic regression included the main effects of treatment group, episode, and center.||||2.827|0.632|0.448
71137852|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|-50.0||||0.105|TWO_SIDED|95.0|-84.6|-15.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||-15.4|-84.6|0.105
70864127|NCT00932737|141213951|OTHER||Odds Ratio (OR)|2.474||||0.03|TWO_SIDED|95.0|1.093|5.604|||Regression, Logistic|Logistic regression included the main effects of treatment group, episode, and center.||||5.604|1.093|0.030
70864128|NCT00932737|141213952|OTHER||Odds Ratio (OR)|1.654||||0.167|TWO_SIDED|95.0|0.81|3.378|||Regression, Logistic|Logistic regression included the main effects of treatment group, episode, and center.||||3.378|0.810|0.167
70864129|NCT00932737|141213953|OTHER|||||||0.256|||||||Log Rank|Log rank test was used for comparison of Hyoscine butylbromide (Buscopan®) 20 mg group versus Placebo group.||||||0.2560
70864130|NCT00932737|141213954|OTHER|||||||0.5179|||||||Log Rank|Log rank test was used for comparison of Hyoscine butylbromide (Buscopan®) 20 mg group versus Placebo group.||||||0.5179
70864131|NCT04399837|141213964|OTHER|The generalized MCP-Mod procedure for time to event endpoints is based on the log hazard ratio of the active doses vs. placebo obtained via a Cox regression model on the time to first GPP flare.|Multiple contrast test|3.041||||0.002|||||||MCP-Mod linear model fit|Model assumption: Dose effect is linear with the increase of dose.||A flat vs. non-flat dose-response relationship across the 3 doses of spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 4 different plausible dose-response patterns (linear, Emax 1, Emax 2 and exponential) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.002
71137853|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|26.7||||0.249|TWO_SIDED|95.0|-19.6|72.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||72.9|-19.6|0.249
71137854|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-28.2|18.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||18.2|-28.2|1.000
71137855|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|-13.3||||0.511|TWO_SIDED|95.0|-30.5|3.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||3.9|-30.5|0.511
71137856|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|33.3||||0.14|TWO_SIDED|95.0|-11.4|78.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||78.1|-11.4|0.140
70864132|NCT04399837|141213964|OTHER|The generalized MCP-Mod procedure for time to event endpoints is based on the log hazard ratio of the active doses vs. placebo obtained via a Cox regression model on the time to first GPP flare.|Multiple contrast test|3.033||||0.002|||||||MCP-Mod Emax2 model fit|Model assumption: 95% of the maximum effect is achieved at low dose.||A flat vs. non-flat dose-response relationship across the 3 doses of spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 4 different plausible dose-response patterns (linear, Emax 1, Emax 2 and exponential) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.002
70864133|NCT04399837|141213964|OTHER|The generalized MCP-Mod procedure for time to event endpoints is based on the log hazard ratio of the active doses vs. placebo obtained via a Cox regression model on the time to first GPP flare.|Multiple contrast test|3.088||||0.002|||||||MCP-Mod Emax1 model fit|Model assumption: 70% of the maximum effect is achieved at low dose.||A flat vs. non-flat dose-response relationship across the 3 doses of spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 4 different plausible dose-response patterns (linear, Emax 1, Emax 2 and exponential) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.002
70864134|NCT04399837|141213964|OTHER|The generalized MCP-Mod procedure for time to event endpoints is based on the log hazard ratio of the active doses vs. placebo obtained via a Cox regression model on the time to first GPP flare.|Multiple contrast test|2.977||||0.003|||||||MCP-Mod exponential model fit|Model assumption: 35% of the maximum effect is achieved at medium dose.||A flat vs. non-flat dose-response relationship across the 3 doses of spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 4 different plausible dose-response patterns (linear, Emax 1, Emax 2 and exponential) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.003
70864135|NCT04399837|141213964|SUPERIORITY|Null hypothesis: Effect of spesolimab 300 mg every 12 weeks on prolonging the time to the first GPP flare up to week 48 ≤ Placebo.|Hazard Ratio (HR)|0.468||||0.0269|TWO_SIDED|95.0|0.206|1.064||"One-sided p-value was computed from the log-rank test stratified by use of systemic GPP medication at randomisation.~Threshold for statistical significance: one-sided p-value ≤ 0.01875."|Log Rank||Hazard ratio and its 95% Confidence Interval are from Cox regression model stratified by use of systemic GPP medication at randomisation.|||1.064|0.206|0.0269
70864136|NCT04399837|141213964|SUPERIORITY|Null hypothesis: Effect of spesolimab 300 mg every 4 weeks on prolonging the time to the first GPP flare up to week 48 ≤ Placebo.|Hazard Ratio (HR)|0.157||||0.0005|TWO_SIDED|95.0|0.046|0.541||"One-sided p-value is computed from the log-rank test stratified by use of systemic GPP medication at randomisation.~Threshold for statistical significance: One-sided p-value ≤0.0125."|Log Rank||Hazard ratio and its 95% CI (confidence interval) are from Cox regression model stratified by use of systemic GPP medication at randomisation.|||0.541|0.046|0.0005
70864137|NCT04399837|141213965|SUPERIORITY|Null hypothesis: The proportion of patients who do not experience a GPP flare up to week 48 on BI 655130 300 mg every 4 weeks ≤ Placebo.|Risk Difference (RD)|-0.39||||0.0013|TWO_SIDED|95.0|-0.621|-0.159||"One-sided p-value was computed from the Cochran-Mantel-Haenszel test stratified by use of systemic GPP medication at randomisation.~one-sided alpha= 0.00625"|Cochran-Mantel-Haenszel||Risk difference=Spesolimab high dose-Placebo.|||-0.159|-0.621|0.0013
70864138|NCT04399837|141213966|SUPERIORITY|Null hypothesis: Effect of BI 655130 300 mg every 4 weeks on prolonging the time to first worsening of PSS up to week 48 ≤ Placebo.|Hazard Ratio (HR)|0.424||||0.0134|TWO_SIDED|95.0|0.197|0.914||"One-sided p-value was computed from the log-rank test stratified by use of systemic GPP medication at randomisation.~one-sided alpha= 0.00625"|Log Rank||spesolimab high dose vs. Placebo|Hazard ratio and its 95% CI (confidence interval) are from Cox regression model stratified by use of systemic GPP medication at randomisation.||0.914|0.197|0.0134
70954435|NCT03547739|141411659|SUPERIORITY||Risk Ratio (RR)|1.21||||0.001|TWO_SIDED|95.0|1.12|1.31|||Chi-squared||Generalized Estimating Equation model with robust standard errors used. Risk Ratios reported were adjusted for baseline education level, wealth index, length of couple relationship, previous couple testing at baseline, and and couple age disparity.|Comparison of the Home Visit arm with Standard Care||1.31|1.12|.001
70864139|NCT04399837|141213967|SUPERIORITY|Null hypothesis: Effect of BI 655130 300 mg every 4 weeks on prolonging the time to the first worsening of DLQI up to week 48 ≤ Placebo.|Hazard Ratio (HR)|0.259||||0.001|TWO_SIDED|95.0|0.109|0.62||One sided p-value was computed from the log-rank test stratified by use of systemic GPP medication at randomisation.|Log Rank||spesolimab high dose vs. Placebo|"Hazard ratio and its 95% CI (confidence interval) are from Cox regression model stratified by use of systemic GPP medication at randomisation.~one-sided alpha= 0.00625"||0.620|0.109|0.0010
70864140|NCT06350474|141213974|NON_INFERIORITY|The non-inferiority margin is -3.|Mean Difference (Final Values)|0.346|||<|0.0001|TWO_SIDED|95.0|-0.5|1.1||One-sided test for non-inferiority.|ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue.|The non-inferiority test was a priori designed to be conducted on the per-protocol (PP) population.||1.1|-0.5|<0.0001
70864141|NCT06350474|141213975|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.414|TWO_SIDED|95.0|-0.4|0.2|||ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue.|||0.2|-0.4|0.414
70864142|NCT06350474|141213976|SUPERIORITY||Mean Difference (Final Values)|0.95||||0.241|TWO_SIDED|95.0|-1.0|2.9|||ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue.|||2.9|-1.0|0.241
70864143|NCT06350474|141213977|SUPERIORITY||Mean Difference (Final Values)|-0.92||||0.233|TWO_SIDED|95.0|-2.5|0.6|||ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue.|||0.6|-2.5|0.233
70864144|NCT06350474|141213978|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.42|TWO_SIDED|95.0|-0.4|0.97|||t-test, 2 sided||Direction of difference is Discontinue - Continue.|||0.97|-0.4|0.42
70864145|NCT06350474|141213979|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.69|TWO_SIDED|95.0|-0.92|0.61|||t-test, 2 sided||Direction of difference is Discontinue - Continue.|||0.61|-0.92|0.69
70864146|NCT06350474|141213980|SUPERIORITY||Difference in % Participants|2.5||||0.275|TWO_SIDED|95.0|-1.5|6.5|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|||6.5|-1.5|0.275
70864147|NCT06350474|141213982|SUPERIORITY||Difference in % Participants|0.8||||0.686|TWO_SIDED|95.0|-1.6|3.4|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|||3.4|-1.6|0.686
70864148|NCT06350474|141213983|SUPERIORITY||Difference in % Participants|13.9||||0.001|TWO_SIDED|95.0|5.6|21.8|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants with at least one AE is the same in Discontinue and Continue arms.||21.8|5.6|0.0010
70864149|NCT06350474|141213984|SUPERIORITY||Rate Ratio|1.95|||<|0.0001|TWO_SIDED|95.0|1.51|2.53|||Poisson Regression|||Rate ratio, confidence interval, and p-value calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks in the DA-discontinue and DA-continue arms are 1486.3 and 1471.4 weeks, respectively. Ratio is Discontinue / Continue.||2.53|1.51|<0.0001
70864150|NCT06350474|141213985|SUPERIORITY||Difference in % Participants|2.03||||0.1758|TWO_SIDED|95.0|-0.6|5.0|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants changing assigned regimen is the same in Discontinue and Continue arms.||5.0|-0.6|0.1758
70864151|NCT02160990|141213991|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<.001
70864152|NCT02160990|141213992|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<.001
70864153|NCT02160990|141213993|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||ANCOVA|||||||0.23
71137857|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|10.0||||0.569|TWO_SIDED|95.0|-14.6|34.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||34.6|-14.6|0.569
71137858|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|4.4||||1|TWO_SIDED|95.0|-19.7|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||28.5|-19.7|1.000
71137859|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|26.7||||0.249|TWO_SIDED|95.0|-19.6|72.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||72.9|-19.6|0.249
71137860|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-28.2|18.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||18.2|-28.2|1.000
71137861|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|-2.2||||1|TWO_SIDED|95.0|-29.0|24.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||24.6|-29.0|1.000
71137862|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|13.3||||0.613|TWO_SIDED|95.0|-35.1|61.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||61.8|-35.1|0.613
71137863|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|-1.7||||1|TWO_SIDED|95.0|-34.8|31.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||31.5|-34.8|1.000
71137864|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|-15.6||||0.615|TWO_SIDED|95.0|-45.9|14.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||14.8|-45.9|0.615
70864154|NCT00369122|141213999|OTHER||||||||||||||||||Based on a report by Laciano, et al. an SAE rate of 5% and AE rate of 35% were considered tolerable and an SAE rate \>=20% and AE rate \>=55% excessive. If there were \>=6 pts with SAES or \>=22 pts with AEs then the treatment would be rejected. This study design provides alpha of 0.05 and power of 90%.|||
71137865|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|20.0||||0.56|TWO_SIDED|95.0|-27.5|67.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||67.5|-27.5|0.560
71137866|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-26.8|36.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared|||Non-responders, Week 52||36.8|-26.8|1.000
71137867|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|-8.9||||1|TWO_SIDED|95.0|-37.7|19.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||19.9|-37.7|1.000
71137868|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|10.0||||1|TWO_SIDED|95.0|-37.1|57.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||57.1|-37.1|1.000
70864155|NCT00408629|141214005|SUPERIORITY_OR_OTHER|||||||0.019||||||Testing for ranked co-primary endpoints occurred in hierarchical order to control for multiple testing. Week 8 remission rate was tested first. If a significant difference in group rates was found at alpha=0.05, Week 52 rate was tested at alpha=0.05.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||Assuming that 5% of the subjects in the placebo group achieve clinical remission at Week 52 or Week 8, a sample size of 250 in each treatment group will be adequate to detect a difference of at least 7 percentage points from the adalimumab group using Chi squared test with 80% power at a 0.05 two-sided significance level.||||0.019
70954436|NCT03547739|141411659|SUPERIORITY||Risk Ratio (RR)|1.26||||0.001|TWO_SIDED|95.0|1.17|1.36|||Chi-squared||Generalized Estimating Equation model with robust standard errors used. Risk Ratios reported were adjusted for baseline education level, wealth index, length of couple relationship, previous couple testing at baseline, and and couple age disparity.|Comparison of HIVST arm with Standard Care arm||1.36|1.17|.001
71137869|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|10.0||||0.588|TWO_SIDED|95.0|-26.1|46.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||46.1|-26.1|0.588
71137870|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|-40.0||||0.058|TWO_SIDED|95.0|-64.8|-15.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||-15.2|-64.8|0.058
71137871|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|16.7||||0.631|TWO_SIDED|95.0|-29.9|63.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||63.2|-29.9|0.631
71137872|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|9.5||||0.597|TWO_SIDED|95.0|-25.7|44.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||44.8|-25.7|0.597
71137873|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|-8.3||||1|TWO_SIDED|95.0|-46.7|30.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||30.0|-46.7|1.000
71137874|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|26.7||||0.361|TWO_SIDED|95.0|-18.5|71.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||71.8|-18.5|0.361
71137875|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|-4.3||||0.812|TWO_SIDED|95.0|-39.6|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||31.0|-39.6|0.812
71137876|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|-27.5||||0.345|TWO_SIDED|95.0|-61.3|6.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||6.3|-61.3|0.345
71137877|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|10.0||||1|TWO_SIDED|95.0|-37.1|57.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||57.1|-37.1|1.000
71137878|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|10.0||||0.588|TWO_SIDED|95.0|-26.1|46.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||46.1|-26.1|0.588
71137879|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|-15.0||||0.657|TWO_SIDED|95.0|-53.9|23.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||23.9|-53.9|0.657
71137880|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|20.0||||0.635|TWO_SIDED|95.0|-25.4|65.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||65.4|-25.4|0.635
71137881|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|10.5||||0.573|TWO_SIDED|95.0|-25.7|46.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||46.7|-25.7|0.573
71137882|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|-34.2||||0.176|TWO_SIDED|95.0|-68.3|-0.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||-0.1|-68.3|0.176
71137883|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|-12.5||||1|TWO_SIDED|95.0|-35.4|10.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||10.4|-35.4|1.000
70864156|NCT00408629|141214006|SUPERIORITY_OR_OTHER|||||||0.004||||||Testing for ranked co-primary endpoints occurred in hierarchical order to control for multiple testing. Week 8 remission rate was tested first. If a significant difference in group rates was found at alpha=0.05, Week 52 rate was tested at alpha=0.05.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||Assuming that 5% of the subjects in the placebo group achieve clinical remission at Week 52 or Week 8, a sample size of 250 in each treatment group will be adequate to detect a difference of at least 7 percentage points from the adalimumab group using Chi squared test with 80% power at a 0.05 two-sided significance level.||||0.004
70864157|NCT00408629|141214007|SUPERIORITY_OR_OTHER|||||||0.047||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.047
70864158|NCT00408629|141214008|SUPERIORITY_OR_OTHER||||||<|0.001||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||<0.001
70864159|NCT00408629|141214009|SUPERIORITY_OR_OTHER|||||||0.002||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.002
70864160|NCT00408629|141214010|SUPERIORITY_OR_OTHER||||||<|0.001||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||<0.001
71137884|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|-12.5||||1|TWO_SIDED|95.0|-35.4|10.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||10.4|-35.4|1.000
70864161|NCT00408629|141214011|SUPERIORITY_OR_OTHER|||||||0.032||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure were needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.032
71137885|NCT02365649|141776322|SUPERIORITY||Risk Difference (RD)|-12.5||||1|TWO_SIDED|95.0|-35.4|10.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||10.4|-35.4|1.000
70864162|NCT00408629|141214012|SUPERIORITY_OR_OTHER|||||||0.009||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.009
70864163|NCT00408629|141214013|SUPERIORITY_OR_OTHER|||||||0.013||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.013
70864164|NCT00408629|141214014|SUPERIORITY_OR_OTHER|||||||0.035||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.035
70864165|NCT00408629|141214015|SUPERIORITY_OR_OTHER|||||||0.058||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.058
70864166|NCT00408629|141214016|SUPERIORITY_OR_OTHER|||||||0.028||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.028
71137886|NCT02365649|141776323|SUPERIORITY||Risk Difference (RD)|-25.0||||1|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||5.0|-55.0|1.000
71137887|NCT02365649|141776323|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-32.5|57.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||57.5|-32.5|1.000
71137888|NCT02365649|141776323|SUPERIORITY||Risk Difference (RD)|-25.0||||0.487|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||5.0|-55.0|0.487
71137889|NCT02365649|141776323|SUPERIORITY||Risk Difference (RD)|11.1||||0.375|TWO_SIDED|95.0|-9.4|31.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ|Non-respoonders||31.6|-9.4|0.375
71137890|NCT02365649|141776323|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-30.5|3.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||3.9|-30.5|1.000
71137891|NCT02365649|141776323|SUPERIORITY||Risk Difference (RD)|8.1||||0.651|TWO_SIDED|95.0|-19.4|35.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||35.6|-19.4|0.651
71137892|NCT02365649|141776323|SUPERIORITY||Risk Difference (RD)|-0.8||||1|TWO_SIDED|95.0|-29.5|27.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||27.8|-29.5|1.000
71137893|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-77.5|77.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||77.5|-77.5|1.000
71137894|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-49.0|49.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||49.0|-49.0|1.000
71137895|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|-50.0||||0.105|TWO_SIDED|95.0|-84.6|-15.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||-15.4|-84.6|0.105
71137896|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-64.5|89.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||89.5|-64.5|1.000
71137897|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-35.7|60.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||60.7|-35.7|1.000
71137898|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|-17.5||||1|TWO_SIDED|95.0|-66.0|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||31.0|-66.0|1.000
71137899|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|62.5||||0.444|TWO_SIDED|95.0|29.0|96.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||96.0|29.0|0.444
71137900|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|25.0||||0.619|TWO_SIDED|95.0|-22.4|72.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||72.4|-22.4|0.619
70864167|NCT00408629|141214017|SUPERIORITY_OR_OTHER|||||||0.006||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.006
70864168|NCT00408629|141214018|SUPERIORITY_OR_OTHER|||||||0.035||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.035
70864169|NCT00408629|141214019|SUPERIORITY_OR_OTHER|||||||0.002||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.002
70864170|NCT00408629|141214020|SUPERIORITY_OR_OTHER|||||||0.007||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.007
70864171|NCT00408629|141214021|SUPERIORITY_OR_OTHER|||||||0.006||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.006
71137901|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|-37.5||||0.231|TWO_SIDED|95.0|-71.0|-4.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||-4.0|-71.0|0.231
71137902|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|-37.5||||1|TWO_SIDED|95.0|-71.0|-4.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||-4.0|-71.0|1.000
71137903|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|25.0||||0.619|TWO_SIDED|95.0|-22.4|72.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||72.4|-22.4|0.619
71137904|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|-17.5||||1|TWO_SIDED|95.0|-66.0|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||31.0|-66.0|1.000
71137905|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|75.0||||0.133|TWO_SIDED|95.0|45.0|100.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||100.0|45.0|0.133
70864172|NCT00191906|141214022|SUPERIORITY_OR_OTHER|||||||0.504||95.0||||P-value for Overall. No adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||0.504
70864173|NCT00191906|141214023|SUPERIORITY_OR_OTHER|||||||0.97||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariates for ADHD-C versus Normal controls.||||0.970
70864174|NCT00191906|141214024|SUPERIORITY_OR_OTHER|||||||0.579||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariates for ADHD-C+RD versus RD controls.||||0.579
70864175|NCT00191906|141214024|SUPERIORITY_OR_OTHER|||||||0.144||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests are performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariates for RD versus RD controls.||||0.144
70864176|NCT00191906|141214025|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment by study-arm-interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||0.005
71137906|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|37.5||||0.315|TWO_SIDED|95.0|-7.5|82.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||82.5|-7.5|0.315
71137907|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|-25.0||||0.487|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||5.0|-55.0|0.487
71137908|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|26.7||||0.249|TWO_SIDED|95.0|-19.6|72.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||72.9|-19.6|0.249
71137909|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|-13.3||||0.487|TWO_SIDED|95.0|-30.5|3.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||3.9|-30.5|0.487
71137910|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|-13.3||||0.511|TWO_SIDED|95.0|-30.5|3.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||3.9|-30.5|0.511
71137911|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|33.3||||0.14|TWO_SIDED|95.0|-11.4|78.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||78.1|-11.4|0.140
71137912|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|10.0||||0.569|TWO_SIDED|95.0|-14.6|34.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||34.6|-14.6|0.569
71137913|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|4.4||||1|TWO_SIDED|95.0|-19.7|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||28.5|-19.7|1.000
71137914|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|13.3||||0.447|TWO_SIDED|95.0|-23.9|50.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||50.6|-23.9|0.447
71137915|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|-6.7||||1|TWO_SIDED|95.0|-19.3|6.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||6.0|-19.3|1.000
71137916|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|4.4||||1|TWO_SIDED|95.0|-19.7|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||28.5|-19.7|1.000
70954437|NCT03547739|141411673|SUPERIORITY||Risk Ratio (RR)|1.08||||0.011|TWO_SIDED|95.0|1.03|1.12|||Chi-squared||Generalized Estimating Equation model (binomial family and log link) with robust standard errors used. Risk Ratios reported were adjusted for baseline education level, wealth, length of couple relationship, and couple age disparity.|Comparison of the Home Visit arm with Standard Care||1.12|1.03|.011
70864177|NCT00191906|141214026|SUPERIORITY_OR_OTHER|||||||0.097||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||0.097
70864178|NCT00191906|141214027|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for study arm, treatment sequence, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||0.003
70864179|NCT00191906|141214028|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||<0.001
70864180|NCT00191906|141214029|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||<0.001
70864181|NCT00191906|141214030|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||<0.001
70864182|NCT00191906|141214031|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||<0.001
70864183|NCT00191906|141214032|SUPERIORITY_OR_OTHER|||||||0.094||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||||||0.094
71137917|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|20.0||||0.56|TWO_SIDED|95.0|-27.5|67.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||67.5|-27.5|0.560
70864184|NCT00191906|141214033|SUPERIORITY_OR_OTHER|||||||0.312||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction||||||0.312
70864185|NCT00191906|141214034|SUPERIORITY_OR_OTHER|||||||0.508||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariates for ADHD-C versus normal controls.||||0.508
70864186|NCT00191906|141214035|SUPERIORITY_OR_OTHER|||||||0.769||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariate for ADHD-C versus normal controls||||0.769
70864187|NCT00191906|141214036|SUPERIORITY_OR_OTHER|||||||0.302||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariates for ADHD-C+RD versus RD controls.||||0.302
70864188|NCT00191906|141214036|SUPERIORITY_OR_OTHER|||||||0.663||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariate for RD versus RD controls.||||0.663
70864189|NCT00191906|141214037|SUPERIORITY_OR_OTHER|||||||0.07||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariate for ADHD-C+RD versus RD controls.||||0.070
70864190|NCT00191906|141214037|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariate for RD versus RD controls.||||0.179
70864191|NCT00333801|141214038|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
70864192|NCT00333801|141214039|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
70864193|NCT00333801|141214040|SUPERIORITY_OR_OTHER_LEGACY||Cohen's d|0.93|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70864194|NCT03633617|141214045|SUPERIORITY||Difference in proportion|55.3|||<|0.0001|TWO_SIDED|95.0|39.58|71.04|||Cochran-Mantel-Haenszel||Difference is dupilumab minus placebo|||71.04|39.58|<0.0001
70864195|NCT03633617|141214045|SUPERIORITY||Difference in proportion|56.0|||<|0.0001|TWO_SIDED|95.0|43.44|68.54|||Cochran-Mantel-Haenszel||Difference is dupilumab minus placebo|||68.54|43.44|<0.0001
70864196|NCT03633617|141214045|SUPERIORITY||Difference in proportion|53.5|||<|0.0001|TWO_SIDED|95.0|41.2|65.79|||Cochran-Mantel-Haenszel||Difference is dupilumab minus placebo|||65.79|41.20|<0.0001
70864197|NCT03633617|141214046|SUPERIORITY||LS Mean Difference|-12.32||||0.0004|TWO_SIDED|95.0|-19.107|-5.537|||ANCOVA||Dupilumab group vs. Placebo|||-5.537|-19.107|0.0004
70864198|NCT03633617|141214046|SUPERIORITY||LS Mean Difference|-0.51||||0.8393|TWO_SIDED|95.0|-5.423|4.406|||ANCOVA||Dupilumab group vs. Placebo|||4.406|-5.423|0.8393
70864199|NCT03633617|141214046|SUPERIORITY||LS Mean Difference|-9.92|||<|0.0001|TWO_SIDED|95.0|-14.811|-5.022|||ANCOVA||Dupilumab group vs. Placebo|||-5.022|-14.811|<0.0001
70864200|NCT03633617|141214047|SUPERIORITY||LS Mean Difference|-68.26|||<|0.0001|TWO_SIDED|95.0|-86.896|-49.615|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-49.615|-86.896|<0.0001
71137918|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|-20.0||||0.231|TWO_SIDED|95.0|-40.2|0.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||0.2|-40.2|0.231
71137919|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|-8.9||||1|TWO_SIDED|95.0|-37.7|19.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||19.9|-37.7|1.000
71137920|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|6.7||||1|TWO_SIDED|95.0|-32.4|45.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||45.7|-32.4|1.000
71137921|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-28.2|18.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||18.2|-28.2|1.000
71137922|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|-2.2||||1|TWO_SIDED|95.0|-29.0|24.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||24.6|-29.0|1.000
71137923|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|10.0||||1|TWO_SIDED|95.0|-37.1|57.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||57.1|-37.1|1.000
71137924|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|-11.4||||0.7|TWO_SIDED|95.0|-45.7|22.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||22.8|-45.7|0.700
71137925|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|-40.0||||0.058|TWO_SIDED|95.0|-64.8|-15.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||-15.2|-64.8|0.058
71137926|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|23.3||||0.354|TWO_SIDED|95.0|-22.5|69.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||69.2|-22.5|0.354
71137927|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|16.2||||0.45|TWO_SIDED|95.0|-18.1|50.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||50.4|-18.1|0.450
71137928|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|-1.7||||1|TWO_SIDED|95.0|-39.1|35.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||35.8|-39.1|1.000
71137929|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|23.3||||0.354|TWO_SIDED|95.0|-22.5|69.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||69.2|-22.5|0.354
71137930|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|9.0||||0.7|TWO_SIDED|95.0|-24.6|42.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||42.7|-24.6|0.700
71137931|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|-14.2||||0.621|TWO_SIDED|95.0|-46.2|17.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||17.9|-46.2|0.621
71137932|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|-6.7||||1|TWO_SIDED|95.0|-51.8|38.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||38.5|-51.8|1.000
71137933|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|-4.3||||0.812|TWO_SIDED|95.0|-39.6|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||31.0|-39.6|0.812
71137934|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|-15.0||||0.657|TWO_SIDED|95.0|-53.9|23.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||23.9|-53.9|0.657
71137935|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|23.3||||0.354|TWO_SIDED|95.0|-22.5|69.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||69.2|-22.5|0.354
71137936|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|16.2||||0.45|TWO_SIDED|95.0|-18.1|50.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||50.4|-18.1|0.450
71137937|NCT02365649|141776324|SUPERIORITY||Risk Difference (RD)|-14.2||||0.621|TWO_SIDED|95.0|-46.2|17.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||17.9|-46.2|0.621
71137938|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|16.7||||1|TWO_SIDED|95.0|-62.2|95.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20%of the cells have expected cell count \<5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||95.6|-62.2|1.000
71137939|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|29.2||||0.592|TWO_SIDED|95.0|-21.3|79.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||79.6|-21.3|0.592
71137940|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-64.8|38.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||38.2|-64.8|1.000
71137941|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-80.0|80.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||80.0|-80.0|1.000
71137942|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-39.7|64.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||64.7|-39.7|1.000
71137943|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|-30.0||||0.545|TWO_SIDED|95.0|-83.2|23.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||23.2|-83.2|0.545
71137944|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|50.0||||0.464|TWO_SIDED|95.0|10.0|90.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||90.0|10.0|0.464
71137945|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-39.7|64.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||64.7|-39.7|1.000
71137946|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|-50.0||||0.182|TWO_SIDED|95.0|-90.0|-10.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||-10.0|-90.0|0.182
71137947|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|16.7||||1|TWO_SIDED|95.0|-62.2|95.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||95.6|-62.2|1.000
71137948|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|29.2||||0.592|TWO_SIDED|95.0|-21.3|79.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||79.6|-21.3|0.592
71137949|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-64.8|38.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||38.2|-64.8|1.000
71137950|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|66.7||||0.429|TWO_SIDED|95.0|28.9|100.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||100.0|28.9|0.429
71137951|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|29.2||||0.592|TWO_SIDED|95.0|-21.3|79.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||79.6|-21.3|0.592
71137952|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|-33.3||||0.455|TWO_SIDED|95.0|-71.1|4.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||4.4|-71.1|0.455
71137953|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|31.7||||0.191|TWO_SIDED|95.0|-14.0|77.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||77.4|-14.0|0.191
71137954|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-22.1|22.1|||Chi-squared|P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||22.1|-22.1|1.000
71137955|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|-8.3||||1|TWO_SIDED|95.0|-24.0|7.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||7.3|-24.0|1.000
71137956|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|23.3||||0.538|TWO_SIDED|95.0|-24.5|71.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||71.2|-24.5|0.538
71137957|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-29.8|29.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||29.8|-29.8|1.000
70864201|NCT03633617|141214047|SUPERIORITY||LS Mean Difference|-79.22|||<|0.0001|TWO_SIDED|95.0|-103.098|-55.338|||ANCOVA||Dupilumab 300 mg Q2W vs Placebo|||-55.338|-103.098|<0.0001
71137958|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|-4.2||||1|TWO_SIDED|95.0|-35.3|27.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||27.0|-35.3|1.000
71137959|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|11.7||||0.515|TWO_SIDED|95.0|-26.7|50.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||50.1|-26.7|0.515
71137960|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-22.1|22.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||22.1|-22.1|1.000
71137961|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|4.2||||1|TWO_SIDED|95.0|-23.6|31.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||31.9|-23.6|1.000
71137962|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|23.3||||0.538|TWO_SIDED|95.0|-24.5|71.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||71.2|-24.5|0.538
71137963|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|-16.7||||0.478|TWO_SIDED|95.0|-37.8|4.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||4.4|-37.8|0.478
71137964|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|-4.2||||1|TWO_SIDED|95.0|-35.3|27.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||27.0|-35.3|1.000
71137965|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|11.7||||0.515|TWO_SIDED|95.0|-26.7|50.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||50.1|-26.7|0.515
71137966|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-17.9|34.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||34.6|-17.9|1.000
71137967|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|4.2||||1|TWO_SIDED|95.0|-23.6|31.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||31.9|-23.6|1.000
71137968|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|25.0||||0.344|TWO_SIDED|95.0|-21.9|71.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 20||71.9|-21.9|0.344
71137969|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|17.9||||0.429|TWO_SIDED|95.0|-17.8|53.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 20||53.5|-17.8|0.429
71137970|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|-10.7||||1|TWO_SIDED|95.0|-46.4|25.0|||Chi-squared|P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 20||25.0|-46.4|1.000
71137971|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-40.4|57.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 28||57.1|-40.4|1.000
70864202|NCT03633617|141214047|SUPERIORITY||LS Mean Difference|-88.62|||<|0.0001|TWO_SIDED|95.0|-112.194|-65.046|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-65.046|-112.194|<0.0001
70864203|NCT03633617|141214048|SUPERIORITY||LS Mean Difference|-37.48||||0.0002|TWO_SIDED|95.0|-57.222|-17.745|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-17.745|-57.222|0.0002
71137972|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|8.3||||0.671|TWO_SIDED|95.0|-29.9|46.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 28||46.6|-29.9|0.671
71137973|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|-13.1||||0.656|TWO_SIDED|95.0|-56.7|30.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 28||30.5|-56.7|0.656
70864204|NCT03633617|141214048|SUPERIORITY||LS Mean Difference|-4.35||||0.5243|TWO_SIDED|95.0|-17.734|9.038|||ANCOVA||Dupilumab 300 mg Q2W vs Placebo|||9.038|-17.734|0.5243
70864205|NCT03633617|141214048|SUPERIORITY||LS Mean Difference|-22.89||||0.0008|TWO_SIDED|95.0|-36.272|-9.513|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-9.513|-36.272|0.0008
70864206|NCT03633617|141214049|SUPERIORITY||LS Mean Difference|-0.759|||<|0.0001|TWO_SIDED|95.0|-0.9061|-0.6127|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-0.6127|-0.9061|<0.0001
70864207|NCT03633617|141214049|SUPERIORITY||LS Mean Difference|-0.666|||<|0.0001|TWO_SIDED|95.0|-0.7773|-0.5538|||ANCOVA||Dupilumab 300 mg Q2W vs Placebo|||-0.5538|-0.7773|<0.0001
70864208|NCT03633617|141214049|SUPERIORITY||LS Mean Difference|-0.682|||<|0.0001|TWO_SIDED|95.0|-0.7929|-0.5707|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-0.5707|-0.7929|<0.0001
70864209|NCT03633617|141214050|SUPERIORITY||LS Mean Difference|-0.741|||<|0.0001|TWO_SIDED|95.0|-0.8842|-0.5978|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-0.5978|-0.8842|<0.0001
70864210|NCT03633617|141214050|SUPERIORITY||LS Mean Difference|-0.661|||<|0.0001|TWO_SIDED|95.0|-0.7674|-0.554|||ANCOVA||Dupilumab 300 mg Q2W vs Placebo|||-0.5540|-0.7674|<0.0001
71137974|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|16.7||||0.627|TWO_SIDED|95.0|-31.4|64.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 36||64.7|-31.4|0.627
70864211|NCT03633617|141214050|SUPERIORITY||LS Mean Difference|-0.672|||<|0.0001|TWO_SIDED|95.0|-0.7778|-0.5655|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-0.5655|-0.7778|<0.0001
70864212|NCT03633617|141214051|SUPERIORITY||LS Mean Difference|-2.9|||<|0.0001|TWO_SIDED|95.0|-3.91|-1.84|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-1.84|-3.91|<0.0001
71137975|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|9.5||||0.701|TWO_SIDED|95.0|-27.7|46.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 36||46.7|-27.7|0.701
71137976|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|-19.0||||0.603|TWO_SIDED|95.0|-56.2|18.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 36||18.1|-56.2|0.603
71137977|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|16.7||||0.627|TWO_SIDED|95.0|-31.4|64.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 44||64.7|-31.4|0.627
71137978|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|2.4||||1|TWO_SIDED|95.0|-34.2|39.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 44||39.0|-34.2|1.000
71137979|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|-4.8||||1|TWO_SIDED|95.0|-47.6|38.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 44||38.0|-47.6|1.000
71137980|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|25.0||||0.344|TWO_SIDED|95.0|-21.9|71.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 52||71.9|-21.9|0.344
71137981|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|25.0||||0.248|TWO_SIDED|95.0|-10.9|60.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 52||60.9|-10.9|0.248
71137982|NCT02365649|141776325|SUPERIORITY||Risk Difference (RD)|-10.7||||1|TWO_SIDED|95.0|-46.4|25.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 52||25.0|-46.4|1.000
71137983|NCT02365649|141776326|SUPERIORITY||Risk Difference (RD)|-25.0||||1|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders||5.0|-55.0|1.000
71137984|NCT02365649|141776326|SUPERIORITY||Risk Difference (RD)|25.0||||0.608|TWO_SIDED|95.0|-20.8|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders||70.8|-20.8|0.608
71137985|NCT02365649|141776326|SUPERIORITY||Risk Difference (RD)|-25.0||||0.487|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders||5.0|-55.0|0.487
71137986|NCT02365649|141776326|SUPERIORITY||Risk Difference (RD)|20.0||||0.25|TWO_SIDED|95.0|-15.1|55.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders||55.1|-15.1|0.250
71137987|NCT02365649|141776326|SUPERIORITY||Risk Difference (RD)|8.3||||0.444|TWO_SIDED|95.0|-7.3|24.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders||24.0|-7.3|0.444
70864213|NCT03633617|141214051|SUPERIORITY||LS Mean Difference|-3.9|||<|0.0001|TWO_SIDED|95.0|-4.86|-3.02|||ANCOVA||Dupilumab 300 mg Q2W vs Placebo|||-3.02|-4.86|<0.0001
70864214|NCT03633617|141214051|SUPERIORITY||LS Mean Difference|-3.8|||<|0.0001|TWO_SIDED|95.0|-4.77|-2.93|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-2.93|-4.77|<0.0001
70864215|NCT03633617|141214052|SUPERIORITY||Difference in proportion|57.5|||<|0.0001|TWO_SIDED|95.0|41.69|73.33|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||73.33|41.69|<0.0001
71137988|NCT02365649|141776326|SUPERIORITY||Risk Difference (RD)|11.1||||0.375|TWO_SIDED|95.0|-9.4|31.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders||31.6|-9.4|0.375
71137989|NCT02365649|141776326|SUPERIORITY||Risk Difference (RD)|3.3||||1|TWO_SIDED|95.0|-31.1|37.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders||37.8|-31.1|1.000
71137990|NCT02365649|141776326|SUPERIORITY||Risk Difference (RD)|22.4||||0.215|TWO_SIDED|95.0|-8.0|52.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders||52.8|-8.0|0.215
71137991|NCT02365649|141776326|SUPERIORITY||Risk Difference (RD)|-0.8||||1|TWO_SIDED|95.0|-29.5|27.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders||27.8|-29.5|1.000
71137992|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-15.0||||0.671|TWO_SIDED|95.0|-55.5|25.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||25.5|-55.5|0.671
71137993|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|10.0||||0.718|TWO_SIDED|95.0|-19.8|39.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||39.8|-19.8|0.718
71137994|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-15.0||||0.461|TWO_SIDED|95.0|-52.4|22.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||22.4|-52.4|0.461
71137995|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-50.0||||0.03|TWO_SIDED|95.0|-85.5|-14.5||Statistically significant at 0.05 level. P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||-14.5|-85.5|0.030
71137996|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-12.5||||0.483|TWO_SIDED|95.0|-42.9|17.9|||Chi-squared|P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||17.9|-42.9|0.483
71137997|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-15.0||||0.431|TWO_SIDED|95.0|-50.8|20.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||20.8|-50.8|0.431
71137998|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-31.1|41.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||41.1|-31.1|1.000
70864216|NCT03633617|141214052|SUPERIORITY||Difference in proportion|72.4|||<|0.0001|TWO_SIDED|95.0|61.05|83.7|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||83.70|61.05|<0.0001
70864217|NCT03633617|141214052|SUPERIORITY||Difference in proportion|74.9|||<|0.0001|TWO_SIDED|95.0|64.25|85.5|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||85.50|64.25|<0.0001
70864218|NCT03633617|141214053|SUPERIORITY||Hodges-Lehmann estimator|-2.25|||<|0.0001|TWO_SIDED|95.0|-2.72|-1.73|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|||-1.7300|-2.7200|<0.0001
71137999|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-7.5||||0.635|TWO_SIDED|95.0|-38.6|23.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||23.6|-38.6|0.635
71138000|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-40.0||||0.056|TWO_SIDED|95.0|-74.8|-5.2||Statistically significant at 0.1 level. P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||-5.2|-74.8|0.056
71138001|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-7.5||||1|TWO_SIDED|95.0|-47.5|32.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||32.5|-47.5|1.000
71138002|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|17.5||||0.296|TWO_SIDED|95.0|-14.7|49.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||49.7|-14.7|0.296
71138003|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-42.4|32.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||32.4|-42.4|1.000
71138004|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-45.9|35.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||35.9|-45.9|1.000
71138005|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|13.8||||0.4|TWO_SIDED|95.0|-17.7|45.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||45.2|-17.7|0.400
71138006|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-15.0||||0.439|TWO_SIDED|95.0|-52.4|22.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||22.4|-52.4|0.439
71138007|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|21.9||||0.259|TWO_SIDED|95.0|-12.8|56.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||56.6|-12.8|0.259
71138008|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-10.5||||0.31|TWO_SIDED|95.0|-30.6|9.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||9.7|-30.6|0.310
71138009|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-19.4||||0.097|TWO_SIDED|95.0|-38.8|-0.1||Statistically significant at 0.1 level. P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||-0.1|-38.8|0.097
71138010|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|24.4||||0.181|TWO_SIDED|95.0|-8.5|57.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||57.2|-8.5|0.181
71138011|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|2.0||||0.826|TWO_SIDED|95.0|-15.9|20.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||20.0|-15.9|0.826
71138012|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-2.6||||1|TWO_SIDED|95.0|-21.2|16.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||16.1|-21.2|1.000
71138013|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|14.4||||0.369|TWO_SIDED|95.0|-16.7|45.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||45.4|-16.7|0.369
71138014|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-0.9||||1|TWO_SIDED|95.0|-18.2|16.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||16.4|-18.2|1.000
71138015|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-2.6||||1|TWO_SIDED|95.0|-21.2|16.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||16.1|-21.2|1.000
71138016|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|11.3||||0.66|TWO_SIDED|95.0|-20.2|42.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||42.7|-20.2|0.660
71138017|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-1.1||||0.908|TWO_SIDED|95.0|-19.7|17.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||17.5|-19.7|0.908
71138018|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-10.1||||0.446|TWO_SIDED|95.0|-27.8|7.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||7.7|-27.8|0.446
71138019|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|20.6||||0.135|TWO_SIDED|95.0|-9.5|50.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||50.8|-9.5|0.135
71138020|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|11.2||||0.306|TWO_SIDED|95.0|-5.7|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||28.1|-5.7|0.306
71138021|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|3.7||||0.686|TWO_SIDED|95.0|-13.4|20.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||20.7|-13.4|0.686
71138022|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|4.9||||0.754|TWO_SIDED|95.0|-25.4|35.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 20||35.2|-25.4|0.754
71138023|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-7.7||||0.548|TWO_SIDED|95.0|-32.6|17.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 20||17.3|-32.6|0.548
71138024|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-22.5||||0.12|TWO_SIDED|95.0|-50.1|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 20||5.0|-50.1|0.120
71138025|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-13.4||||0.403|TWO_SIDED|95.0|-44.5|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 28||17.7|-44.5|0.403
71138026|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-8.0||||0.533|TWO_SIDED|95.0|-33.0|17.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 28||17.0|-33.0|0.533
70864219|NCT03633617|141214053|SUPERIORITY||Hodges-Lehmann estimator|-1.84|||<|0.0001|TWO_SIDED|95.0|-2.42|-1.11|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|||-1.1100|-2.4200|<0.0001
70864220|NCT03633617|141214053|SUPERIORITY||Hodges-Lehmann estimator|-1.85|||<|0.0001|TWO_SIDED|95.0|-2.44|-1.15|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|||-1.1500|-2.4400|<0.0001
70864221|NCT03633617|141214054|SUPERIORITY||Hodges-Lehmann estimator|-1.59|||<|0.0001|TWO_SIDED|95.0|-1.74|-1.27|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|||-1.2700|-1.7400|<0.0001
70864222|NCT03633617|141214054|SUPERIORITY||Hodges-Lehmann estimator|-1.255|||<|0.0001|TWO_SIDED|95.0|-1.73|-1.05|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|||-1.0500|-1.7300|<0.0001
70864223|NCT03633617|141214054|SUPERIORITY||Hodges-Lehmann estimator|-1.275|||<|0.0001|TWO_SIDED|95.0|-1.82|-1.07|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|||-1.0700|-1.8200|<0.0001
70864224|NCT03633617|141214055|SUPERIORITY||Difference in proportion|21.9||||0.0017|TWO_SIDED|95.0|9.42|34.38|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||34.38|9.42|0.0017
70864225|NCT03633617|141214055|SUPERIORITY||Difference in proportion|27.6|||<|0.0001|TWO_SIDED|95.0|17.2|38.09|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||38.09|17.20|<0.0001
71138027|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-8.9||||0.539|TWO_SIDED|95.0|-37.2|19.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 28||19.4|-37.2|0.539
70864226|NCT03633617|141214055|SUPERIORITY||Difference in proportion|28.9|||<|0.0001|TWO_SIDED|95.0|18.36|39.46|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||39.46|18.36|<0.0001
70864227|NCT03633617|141214056|SUPERIORITY||LS Mean Difference|-0.368||||0.0077|TWO_SIDED|95.0|-0.6388|-0.0975|||ANCOVA||Dupilumab group vs Placebo|||-0.0975|-0.6388|0.0077
70864228|NCT03633617|141214056|SUPERIORITY||LS Mean Difference|-0.015||||0.8586|TWO_SIDED|95.0|-0.1782|0.1485|||ANCOVA||Dupilumab group vs. Placebo|||0.1485|-0.1782|0.8586
70864229|NCT03633617|141214056|SUPERIORITY||LS Mean Difference|-0.309||||0.0002|TWO_SIDED|95.0|-0.4703|-0.1471|||ANCOVA||Dupilumab group vs. Placebo|||-0.1471|-0.4703|0.0002
70864230|NCT03633617|141214057|SUPERIORITY||LS Mean Difference|-2.0||||0.0467|TWO_SIDED|95.0|-3.87|-0.03|||ANCOVA||Dupilumab group vs. Placebo|||-0.03|-3.87|0.0467
70864231|NCT03633617|141214057|SUPERIORITY||LS Mean Difference|-0.5||||0.5469||95.0|-2.03|1.08|||ANCOVA||Dupilumab group vs. Placebo|||1.08|-2.03|0.5469
70864232|NCT03633617|141214057|SUPERIORITY||LS Mean Difference|-1.5||||0.0718|TWO_SIDED|95.0|-3.0|0.13|||ANCOVA||Dupilumab group vs. Placebo|||0.13|-3.0|0.0718
70864233|NCT03633617|141214058|SUPERIORITY||LS Mean Difference|-1.7||||0.0051|TWO_SIDED|95.0|-2.93|-0.52|||ANCOVA||Dupilumab group vs. Placebo|||-0.52|-2.93|0.0051
70864234|NCT03633617|141214058|SUPERIORITY||LS Mean Difference|-0.5||||0.3152|TWO_SIDED|95.0|-1.38|0.44|||ANCOVA||Dupilumab group vs. Placebo|||0.44|-1.38|0.3152
70864235|NCT03633617|141214058|SUPERIORITY||LS Mean Difference|-1.4||||0.0037|TWO_SIDED|95.0|-2.3|0.45|||ANCOVA||Dupilumab group vs. Placebo|||0.45|-2.30|0.0037
70864236|NCT03633617|141214059|SUPERIORITY||Difference in proportion|-12.7||||0.017|TWO_SIDED|95.0|-23.21|-2.26|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||-2.26|-23.21|0.0170
71138028|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|4.9||||0.754|TWO_SIDED|95.0|-25.4|35.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 36||35.2|-25.4|0.754
70864237|NCT03633617|141214059|SUPERIORITY||Difference in proportion|-1.3||||0.5493|TWO_SIDED|95.0|-5.51|2.93|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||2.93|-5.51|0.5493
70864238|NCT03633617|141214059|SUPERIORITY||Difference in proportion|0.0||||0.9887|TWO_SIDED|95.0|-4.9|5.02|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||5.02|-4.9|0.9887
70864239|NCT01890746|141214088|OTHER|Bioequivalence|Ratio of geometric means (%)|114.9|||||TWO_SIDED|90.0|99.5|132.7||||||||132.7|99.5|
70864240|NCT01890746|141214089|OTHER|Bioequivalence|Ratio of geometric means (%)|105.2|||||TWO_SIDED|90.0|97.1|114.0||||||||114.0|97.1|
70864241|NCT01890746|141214090|OTHER|Bioequivalence|Ratio of geometric means (%)|92.0|||||TWO_SIDED|90.0|76.8|110.2||||||||110.2|76.8|
70864242|NCT01890746|141214091|OTHER|Bioequivalence|Ratio of geometric means (%)|101.8|||||TWO_SIDED|90.0|92.9|111.7||||||||111.7|92.9|
70864243|NCT01890746|141214092|OTHER|Bioequivalence|Ratio of geometric means (%)|121.0|||||TWO_SIDED|90.0|102.5|142.8||||||||142.8|102.5|
70864244|NCT01890746|141214093|OTHER|Bioequivalence|Ratio of geometric means (%)|106.5|||||TWO_SIDED|90.0|95.0|119.4||||||||119.4|95.0|
70864245|NCT01890746|141214094|OTHER|Bioequivalence|Ratio of geometric means (%)|91.7|||||TWO_SIDED|90.0|76.5|110.0||||||||110.0|76.5|
70864246|NCT01890746|141214095|OTHER|Bioequivalence|Ratio of geometric means (%)|101.4|||||TWO_SIDED|90.0|92.4|111.2||||||||111.2|92.4|
70864247|NCT01890746|141214096|OTHER|Bioequivalence|Ratio of geometric means (%)|120.0|||||TWO_SIDED|90.0|100.7|142.6||||||||142.6|100.7|
70864248|NCT01890746|141214097|OTHER|Bioequivalence|Ratio of geometric means (%)|105.2|||||TWO_SIDED|90.0|93.6|118.3||||||||118.3|93.6|
70864249|NCT01890746|141214098|OTHER|Bioequivalence|Ratio of geometric means (%)|80.4|||||TWO_SIDED|90.0|57.2|113.0||||||||113.0|57.2|
70864250|NCT01890746|141214099|OTHER|Bioequivalence|Ratio of geometric means (%)|106.3|||||TWO_SIDED|90.0|87.6|129.0||||||||129.0|87.6|
70864251|NCT01890746|141214100|OTHER|Bioequivalence|Ratio of geometric means (%)|127.1|||||TWO_SIDED|90.0|84.2|191.9||||||||191.9|84.2|
70864252|NCT01890746|141214101|OTHER|Bioequivalence|Ratio of geometric means (%)|110.5|||||TWO_SIDED|90.0|83.9|145.7||||||||145.7|83.9|
70864253|NCT01890746|141214102|OTHER|Bioequivalence|Ratio of geometric means (%)|286.4|||||TWO_SIDED|90.0|90.1|910.7||||||||910.7|90.1|
70864254|NCT01890746|141214103|OTHER|Bioequivalence|Ratio of geometric means (%)|202.3|||||TWO_SIDED|90.0|131.3|311.8||||||||311.8|131.3|
70864255|NCT01890746|141214105|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.7461|TWO_SIDED|95.0|0.28|2.48|||Log Rank|||||2.48|0.28|0.7461
70864256|NCT01890746|141214106|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.6175|TWO_SIDED|95.0|0.74|1.63|||Log Rank|||||1.63|0.74|0.6175
71138029|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-14.5||||0.256|TWO_SIDED|95.0|-39.4|10.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 36||10.3|-39.4|0.256
71138030|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-27.8||||0.055|TWO_SIDED|95.0|-54.7|-0.8||Statistically significant at 0.1 level.|Chi-squared|P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 36||-0.8|-54.7|0.055
70864257|NCT01890746|141214107|SUPERIORITY||Odds Ratio (OR)|0.5281||||0.3224|TWO_SIDED|95.0|0.1084|2.2086|||Cochran-Mantel-Haenszel|||||2.2086|0.1084|0.3224
71138031|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|2.2||||0.887|TWO_SIDED|95.0|-28.8|33.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 44||33.2|-28.8|0.887
71138032|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|14.5||||0.256|TWO_SIDED|95.0|-10.3|39.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 44||39.4|-10.3|0.256
70864258|NCT01890746|141214109|SUPERIORITY|||||||0.6942|||||||Wilcoxon rank-sum test|||||||0.6942
71138033|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-9.0||||0.518|TWO_SIDED|95.0|-36.0|17.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 44||17.9|-36.0|0.518
71138034|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|6.3||||0.695|TWO_SIDED|95.0|-25.1|37.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 52||37.6|-25.1|0.695
71138035|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|11.4||||0.373|TWO_SIDED|95.0|-13.5|36.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 52||36.4|-13.5|0.373
71138036|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-6.9||||0.628|TWO_SIDED|95.0|-34.6|20.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 52||20.8|-34.6|0.628
71138037|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-15.0||||1|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 20||0.6|-30.6|1.000
71138038|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-0.7||||1|TWO_SIDED|95.0|-22.4|20.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 20||20.9|-22.4|1.000
71138039|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-15.0||||0.251|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 20||0.6|-30.6|0.251
70864259|NCT01890746|141214110|SUPERIORITY||Odds Ratio (OR)|1.1151||||0.7397|TWO_SIDED|95.0|0.5585|2.229|||Cochran-Mantel-Haenszel|||||2.2290|0.5585|0.7397
70864260|NCT01890746|141214111|SUPERIORITY||Hazard Ratio (HR)|2.46||||0.0781|TWO_SIDED|95.0|0.95|6.38|||Log Rank|||||6.38|0.95|0.0781
70864261|NCT01890746|141214115|SUPERIORITY||Odds Ratio (OR)|0.8749||||0.7122|TWO_SIDED|95.0|0.4023|1.8943|||Cochran-Mantel-Haenszel|||||1.8943|0.4023|0.7122
70864262|NCT01890746|141214116|SUPERIORITY||Hazard Ratio (HR)|1.54||||0.0688|TWO_SIDED|95.0|0.96|2.47|||Log Rank|||||2.47|0.96|0.0688
71138040|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 28||3.1|-23.1|1.000
71138041|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-0.5||||1|TWO_SIDED|95.0|-18.7|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 28||17.7|-18.7|1.000
70954438|NCT03547739|141411673|SUPERIORITY||Risk Ratio (RR)|1.02||||0.011|TWO_SIDED|95.0|0.97|1.08|||Chi-squared||Generalized Estimating Equation model (binomial family and log link) with robust standard errors used. Risk Ratios reported were adjusted for baseline education level, wealth, length of couple relationship, and couple age disparity.|Comparison of the HIVST arm with Standard Care||1.08|0.97|0.011
70954439|NCT03547739|141411674|OTHER||Kaplan Meier estimates|0.92||||0.087|TWO_SIDED|95.0|0.86|0.95|||Log Rank|||||0.95|0.86|0.087
70954440|NCT03547739|141411674|OTHER||Kaplan Meier estimates|0.96||||0.087|TWO_SIDED|95.0|0.91|0.98|||Log Rank|||||0.98|0.91|0.087
70864263|NCT02642029|141214118|EQUIVALENCE|Tested the null hypothesis of no difference between iTBS and sham TBS on IDT accuracy.|Beta coefficient for timexiTBS interact|-0.099|STANDARD_ERROR_OF_MEAN|0.051||0.51|TWO_SIDED|95.0|-0.1989|0.0002||Significance threshold of p \< 0.05, two-sided.|Mixed Models Analysis|Model included time (pre, post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS).||Conducted a mixed effects analysis, with IDT accuracy as the dependent variable and time (pre, post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS) as the independent variables. P-value here is for the iTBS (vs. sham) x time interaction.||.0002|-.1989|0.51
70864264|NCT02642029|141214118|EQUIVALENCE|Tested the null hypothesis of no difference between iTBS and sham TBS on IDT accuracy.|Beta coefficient for timexcTBS interact|-0.0757|STANDARD_ERROR_OF_MEAN|0.052||0.143|TWO_SIDED|95.0|-0.177|0.0256||Significance threshold of p \< 0.05, two-sided.|Mixed Models Analysis|Model included time (pre, post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS).||Conducted a mixed effects analysis, with IDT accuracy as the dependent variable and time (pre, post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS) as the independent variables. P-value here is for the cTBS (vs. sham) x time interaction.||.0256|-.1770|0.143
71138042|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-10.0||||0.501|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 28||3.1|-23.1|0.501
70954441|NCT03547739|141411674|OTHER||Kaplan Meier estimates|0.98||||0.087|TWO_SIDED|95.0|0.93|0.99|||Log Rank|||||0.99|0.93|0.087
70954442|NCT02003222|141411745|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.003|TWO_SIDED|95.0|0.25|0.76|||Log Rank||hazard ratio: blinatumomab + chemotherapy vs. chemotherapy alone|||0.76|0.25|0.003
71138043|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|9.5||||0.488|TWO_SIDED|95.0|-3.0|22.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 36||22.1|-3.0|0.488
71138044|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 44||3.1|-23.1|1.000
71138045|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-10.0||||0.232|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 44||3.1|-23.1|0.232
71138046|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|-10.0||||0.501|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 44||3.1|-23.1|0.501
71138047|NCT02365649|141776327|SUPERIORITY||Risk Difference (RD)|9.5||||0.488|TWO_SIDED|95.0|-3.0|22.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 52||22.1|-3.0|0.488
71138048|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|20.0||||0.295|TWO_SIDED|95.0|2.5|37.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||37.5|2.5|0.295
71138049|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|13.8||||0.355|TWO_SIDED|95.0|-7.4|34.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||34.9|-7.4|0.355
71138050|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|-20.0||||0.384|TWO_SIDED|95.0|-55.1|15.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||15.1|-55.1|0.384
71138051|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|-22.5||||0.311|TWO_SIDED|95.0|-59.5|14.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||14.5|-59.5|0.311
70954443|NCT02003222|141411746|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.015|TWO_SIDED|95.0|0.31|0.89|||Log Rank||hazard ratio: Blinatumomab + Chemotherapy vs. Chemotherapy alone|||0.89|0.31|0.015
71138052|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|-16.3||||0.422|TWO_SIDED|95.0|-43.8|11.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||11.3|-43.8|0.422
71138053|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|-25.0||||0.181|TWO_SIDED|95.0|-59.2|9.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||9.2|-59.2|0.181
71138054|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|25.0||||0.281|TWO_SIDED|95.0|6.0|44.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||44.0|6.0|0.281
71138055|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-28.5|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||28.5|-28.5|1.000
71138056|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|-25.0||||0.231|TWO_SIDED|95.0|-61.3|11.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||11.3|-61.3|0.231
71138057|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|27.5||||0.214|TWO_SIDED|95.0|-3.9|58.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||58.9|-3.9|0.214
71138058|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|21.3||||0.277|TWO_SIDED|95.0|-7.5|50.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||50.0|-7.5|0.277
71138059|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|-20.0||||0.442|TWO_SIDED|95.0|-57.2|17.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||17.2|-57.2|0.442
71138060|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|20.0||||0.419|TWO_SIDED|95.0|-17.1|57.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||57.1|-17.1|0.419
71138061|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|20.0||||0.214|TWO_SIDED|95.0|-10.4|50.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||50.4|-10.4|0.214
71138062|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|-15.0||||0.439|TWO_SIDED|95.0|-52.4|22.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||22.4|-52.4|0.439
71138063|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|23.1||||0.284|TWO_SIDED|95.0|-10.1|56.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||56.4|-10.1|0.284
71138064|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|0.2||||0.988|TWO_SIDED|95.0|-23.9|24.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||24.3|-23.9|0.988
70954444|NCT02003222|141411747|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.67|TWO_SIDED|95.0|0.22|2.65|||Log Rank|||||2.65|0.22|0.67
70954445|NCT02003222|141411748|SUPERIORITY||Hazard Ratio (HR)|1.0||||1|TWO_SIDED|95.0|0.28|3.63|||Log Rank|||||3.63|0.28|1.00
70954446|NCT02003222|141411749|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.41|TWO_SIDED|95.0|0.17|2.11|||Log Rank||hazard ratio: blinatumomab + chemotherapy vs. chemotherapy alone|||2.11|0.17|0.41
70864265|NCT02642029|141214119|EQUIVALENCE|Tested the null hypothesis of no difference between iTBS and sham TBS on N-back accuracy.|Beta coefficient for timexiTBS interact|-0.0446||||0.626|TWO_SIDED|||||Significance threshold was p \< 0.05, two-sided.|Mixed Models Analysis|||"Conducted a generalized linear mixed model fit by maximum likelihood (Laplace Approximation) \['glmerMod' in R\] with binomial (logit) distribution.~N-back accuracy was the dependent variable. Time (pre vs. post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS) were the independent variables. P-value here is for the iTBS (vs. sham) x time interaction."||||.626
70864266|NCT02642029|141214119|EQUIVALENCE|Tested the null hypothesis of no difference between cTBS and sham TBS on N-back accuracy.|Beta coefficient for timexcTBS interact|-0.0903||||0.322|TWO_SIDED|||||Significance threshold was p \< 0.05, two-sided.|Mixed Models Analysis|||"Conducted a generalized linear mixed model fit by maximum likelihood (Laplace Approximation) \['glmerMod' in R\] with binomial (logit) distribution.~N-back accuracy was the dependent variable. Time (pre vs. post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS) were the independent variables. P-value here is for the cTBS (vs. sham) x time interaction."||||0.322
71138065|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|-12.1||||0.37|TWO_SIDED|95.0|-38.1|13.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||13.9|-38.1|0.370
71138066|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|25.6||||0.268|TWO_SIDED|95.0|-8.9|60.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||60.2|-8.9|0.268
71138067|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|-5.0||||0.665|TWO_SIDED|95.0|-27.4|17.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||17.5|-27.4|0.665
71138068|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|-3.9||||0.759|TWO_SIDED|95.0|-28.9|21.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||21.0|-28.9|0.759
71138069|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|21.9||||0.259|TWO_SIDED|95.0|-12.8|56.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||56.6|-12.8|0.259
71138070|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|-1.7||||0.88|TWO_SIDED|95.0|-23.2|19.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||19.9|-23.2|0.880
71138071|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|-10.7||||0.355|TWO_SIDED|95.0|-32.7|11.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||11.2|-32.7|0.355
71138072|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-27.1|37.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||37.1|-27.1|1.000
71138073|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|4.4||||0.688|TWO_SIDED|95.0|-17.0|25.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||25.9|-17.0|0.688
71138074|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|1.1||||0.927|TWO_SIDED|95.0|-22.3|24.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||24.5|-22.3|0.927
71138075|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|27.5||||0.075|TWO_SIDED|95.0|-5.0|60.0||Statistically significant at 0.1 level. P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||60.0|-5.0|0.075
71138076|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|14.0||||0.154|TWO_SIDED|95.0|-4.8|32.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||32.7|-4.8|0.154
70864267|NCT02642029|141214120|EQUIVALENCE|Tested the null hypothesis of no difference between iTBS and sham TBS on N-back accuracy.|Beta coefficient for timexiTBS interact|-9.797||||0.1118|TWO_SIDED|||||Significance threshold of p \< 0.05, two-sided|Mixed Models Analysis|||"Conducted a generalized linear mixed model fit by maximum likelihood (Laplace Approximation) \['glmerMod' in R\] with gamma distribution.~N-back reaction time (RT) was the dependent variable. Time (pre vs. post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS) were the independent variables. P-value here is for the iTBS (vs. sham) x time interaction."||||0.1118
71138077|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|4.9||||0.707|TWO_SIDED|95.0|-14.4|24.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||24.2|-14.4|0.707
71138078|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|25.0||||0.085|TWO_SIDED|95.0|10.0|40.0||Statistically significant at 0.1 level. P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 20||40.0|10.0|0.085
71138079|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|14.7||||0.137|TWO_SIDED|95.0|-4.0|33.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 20||33.3|-4.0|0.137
71138080|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|-11.8||||0.37|TWO_SIDED|95.0|-38.2|14.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 20||14.5|-38.2|0.370
71138081|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|-3.6||||1|TWO_SIDED|95.0|-31.6|24.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 28||24.4|-31.6|1.000
71138082|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|-16.4||||0.174|TWO_SIDED|95.0|-39.8|7.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 28||7.0|-39.8|0.174
71138083|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|-17.1||||0.203|TWO_SIDED|95.0|-43.9|9.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 28||9.7|-43.9|0.203
71138084|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|20.1||||0.286|TWO_SIDED|95.0|-4.5|44.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 36||44.7|-4.5|0.286
71138085|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|-3.6||||0.773|TWO_SIDED|95.0|-27.7|20.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 36||20.6|-27.7|0.773
71138086|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|-23.5||||0.101|TWO_SIDED|95.0|-51.2|4.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 36||4.1|-51.2|0.101
71138087|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|15.2||||0.332|TWO_SIDED|95.0|-14.1|44.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 44||44.4|-14.1|0.332
71138088|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|16.2||||0.189|TWO_SIDED|95.0|-7.5|39.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 44||39.8|-7.5|0.189
71138089|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|-14.1||||0.329|TWO_SIDED|95.0|-42.2|13.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 44||13.9|-42.2|0.329
71138090|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|24.6||||0.124|TWO_SIDED|95.0|-4.8|53.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 52||53.9|-4.8|0.124
71138091|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|15.2||||0.234|TWO_SIDED|95.0|-9.5|39.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 52||39.9|-9.5|0.234
70864268|NCT02642029|141214120|EQUIVALENCE|Tested the null hypothesis of no difference between cTBS and sham TBS on N-back accuracy.|Beta coefficient for timexcTBS interact|-47.764||||9e-08|TWO_SIDED|||||Significance threshold was p \< 0.05, two-sided.|Mixed Models Analysis|||"Conducted a generalized linear mixed model fit by maximum likelihood (Laplace Approximation) \['glmerMod' in R\] with gamma distribution.~N-back reaction time (RT) was the dependent variable. Time (pre vs. post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS) were the independent variables. P-value here is for the cTBS (vs. sham) x time interaction."||||0.00000009
71138092|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|-10.0||||0.484|TWO_SIDED|95.0|-37.8|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 52||17.7|-37.8|0.484
71138093|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-57.3|37.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 20||37.3|-57.3|1.000
71138094|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|-11.2||||0.431|TWO_SIDED|95.0|-38.9|16.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 20||16.5|-38.9|0.431
71138095|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|-20.7||||0.25|TWO_SIDED|95.0|-48.5|7.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 20||7.1|-48.5|0.250
71138096|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-40.9|50.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 28||50.9|-40.9|1.000
70864269|NCT02642029|141214121|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.91||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||0.910
70864270|NCT02642029|141214121|OTHER|Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|beta coefficient for depressed mood|0.00071||||0.243|TWO_SIDED|95.0|-0.00048|0.0019|||Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, depressed mood). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00190|-0.00048|0.243
71138097|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|-1.0||||1|TWO_SIDED|95.0|-25.2|23.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 28||23.3|-25.2|1.000
71138098|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|-5.7||||1|TWO_SIDED|95.0|-31.1|19.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 28||19.6|-31.1|1.000
71138099|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|10.0||||0.544|TWO_SIDED|95.0|-35.2|55.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 36||55.2|-35.2|0.544
71138100|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|-0.7||||1|TWO_SIDED|95.0|-22.4|20.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 36||20.9|-22.4|1.000
71138101|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|-7.9||||0.627|TWO_SIDED|95.0|-28.5|12.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 36||12.8|-28.5|0.627
71138102|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 44||3.1|-23.1|1.000
71138103|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|-0.5||||1|TWO_SIDED|95.0|-18.7|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 44||17.7|-18.7|1.000
71138104|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|4.3||||1|TWO_SIDED|95.0|-18.3|26.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 44||26.8|-18.3|1.000
71138105|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|14.3||||0.232|TWO_SIDED|95.0|-0.7|29.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 52||29.3|-0.7|0.232
71138106|NCT02365649|141776328|SUPERIORITY||Risk Difference (RD)|7.1||||0.412|TWO_SIDED|95.0|-6.3|20.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 52||20.6|-6.3|0.412
71138107|NCT02365649|141776329|SUPERIORITY||LS Mean of Difference|-745.7||||0.356|TWO_SIDED|95.0|-2369.73|878.37||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 28||878.37|-2369.73|0.356
71138108|NCT02365649|141776329|SUPERIORITY||LS Mean of Difference|-1119.5||||0.158|TWO_SIDED|95.0|-2698.52|459.5||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 28||459.50|-2698.52|0.158
71138109|NCT02365649|141776329|SUPERIORITY||LS Mean of Difference|-1166.0||||0.322|TWO_SIDED|95.0|-3531.3|1199.32||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 28||1199.32|-3531.30|0.322
71138110|NCT02365649|141776329|SUPERIORITY||LS Mean of Difference|-828.2||||0.287|TWO_SIDED|95.0|-2387.16|730.75||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 52||730.75|-2387.16|0.287
71138111|NCT02365649|141776329|SUPERIORITY||LS Mean of Difference|-1286.1||||0.088|TWO_SIDED|95.0|-2772.59|200.43||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.1 level.||Responders, Week 52||200.43|-2772.59|0.088
70864271|NCT02642029|141214122|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.83||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||0.830
71138112|NCT02365649|141776329|SUPERIORITY||LS Mean of Difference|-502.2||||0.613|TWO_SIDED|95.0|-2505.74|1501.38||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 52||1501.38|-2505.74|0.613
71138113|NCT02365649|141776329|SUPERIORITY||LS Mean of Difference|283.4||||0.609|TWO_SIDED|95.0|-823.64|1390.49||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 28||1390.49|-823.64|0.609
71138114|NCT02365649|141776329|SUPERIORITY||LS Mean of Difference|-78.2||||0.855|TWO_SIDED|95.0|-930.47|774.16||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 28||774.16|-930.47|0.855
71138115|NCT02365649|141776329|SUPERIORITY||LS Mean of Difference|283.5||||0.584|TWO_SIDED|95.0|-751.66|1318.57||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 28||1318.57|-751.66|0.584
71138116|NCT02365649|141776329|SUPERIORITY||LS Mean of Difference|356.6||||0.624|TWO_SIDED|95.0|-1095.03|1808.19||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 52||1808.19|-1095.03|0.624
71138117|NCT02365649|141776329|SUPERIORITY||LS Mean of Difference|-135.1||||0.806|TWO_SIDED|95.0|-1233.48|963.25||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 52||963.25|-1233.48|0.806
71138118|NCT02365649|141776329|SUPERIORITY||LS Mean of Difference|186.2||||0.793|TWO_SIDED|95.0|-1229.59|1602.06||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 52||1602.06|-1229.59|0.793
71138119|NCT02365649|141776329|SUPERIORITY||LS Mean of Difference|-304.8||||0.561|TWO_SIDED|95.0|-1350.04|740.44||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 28||740.44|-1350.04|0.561
71138120|NCT02365649|141776329|SUPERIORITY||LS Mean of Difference|-1119.0||||0.024|TWO_SIDED|95.0|-2083.81|-154.11||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.05 level.||Clinical responders, Week 28||-154.11|-2083.81|0.024
71138121|NCT02365649|141776329|SUPERIORITY||LS Mean of Difference|-819.3||||0.156|TWO_SIDED|95.0|-1959.79|321.21||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 28||321.21|-1959.79|0.156
71138122|NCT02365649|141776329|SUPERIORITY||LS Mean of Difference|-346.6||||0.58|TWO_SIDED|95.0|-1592.66|899.45||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 52||899.45|-1592.66|0.580
71138123|NCT02365649|141776329|SUPERIORITY||LS Mean of Difference|-1275.9||||0.029|TWO_SIDED|95.0|-2415.88|-135.92||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.05 level.||Clinical responders, Week 52||-135.92|-2415.88|0.029
71138124|NCT02365649|141776329|SUPERIORITY||LS Mean of Difference|-534.9||||0.431|TWO_SIDED|95.0|-1883.23|813.5||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 52||813.50|-1883.23|0.431
71138125|NCT02365649|141776329|SUPERIORITY||LS Mean of Difference|-25.4||||0.965|TWO_SIDED|95.0|-1200.67|1149.95||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 28||1149.95|-1200.67|0.965
71138126|NCT02365649|141776329|SUPERIORITY||LS Mean of Difference|623.6||||0.123|TWO_SIDED|95.0|-183.52|1430.64||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 28||1430.64|-183.52|0.123
71138127|NCT02365649|141776329|SUPERIORITY||LS Mean of Difference|368.2||||0.591|TWO_SIDED|95.0|-1031.23|1767.6||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 28||1767.60|-1031.23|0.591
71138128|NCT02365649|141776329|SUPERIORITY||LS Mean of Difference|192.2||||0.642|TWO_SIDED|95.0|-648.22|1032.68||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 52||1032.68|-648.22|0.642
71138129|NCT02365649|141776329|SUPERIORITY||LS Mean of Difference|455.8||||0.093|TWO_SIDED|95.0|-81.37|992.95||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.1 level.||Clinical non-responders, Week 52||992.95|-81.37|0.093
71138130|NCT02365649|141776329|SUPERIORITY||LS Mean of Difference|463.6||||0.296|TWO_SIDED|95.0|-428.99|1356.2||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 52||1356.20|-428.99|0.296
71138131|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|-2.0||||0.822|TWO_SIDED|95.0|-19.83|15.83||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 20||15.83|-19.83|0.822
71138132|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|-6.4||||0.386|TWO_SIDED|95.0|-20.97|8.25||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 20||8.25|-20.97|0.386
71138133|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|12.9||||0.136|TWO_SIDED|95.0|-4.22|29.95||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 20||29.95|-4.22|0.136
71138134|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|1.0||||0.912|TWO_SIDED|95.0|-17.87|19.97||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 28||19.97|-17.87|0.912
71138135|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|-12.3||||0.118|TWO_SIDED|95.0|-27.77|3.25||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 28||3.25|-27.77|0.118
71138136|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|12.5||||0.171|TWO_SIDED|95.0|-5.61|30.65||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 28||30.65|-5.61|0.171
71138137|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|-6.9||||0.479|TWO_SIDED|95.0|-26.5|12.63||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 36||12.63|-26.50|0.479
71138138|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|-17.1||||0.037|TWO_SIDED|95.0|-33.12|-1.04||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.05 level.||Responders, Week 36||-1.04|-33.12|0.037
71138139|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|6.9||||0.463|TWO_SIDED|95.0|-11.86|25.65||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 36||25.65|-11.86|0.463
71138140|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|-4.6||||0.627|TWO_SIDED|95.0|-23.59|14.37||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 44||14.37|-23.59|0.627
71138141|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|-12.2||||0.122|TWO_SIDED|95.0|-27.75|3.37||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 44||3.37|-27.75|0.122
71138142|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|10.7||||0.243|TWO_SIDED|95.0|-7.49|28.89||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 44||28.89|-7.49|0.243
71138143|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|-4.2||||0.658|TWO_SIDED|95.0|-22.95|14.63||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 52||14.63|-22.95|0.658
71138144|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|-12.3||||0.115|TWO_SIDED|95.0|-27.69|3.12||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 52||3.12|-27.69|0.115
71138145|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|10.0||||0.267|TWO_SIDED|95.0|-7.96|28.06||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 52||28.06|-7.96|0.267
71138146|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|0.2||||0.974|TWO_SIDED|95.0|-9.74|10.06||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 20||10.06|-9.74|0.974
71138147|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|-0.5||||0.882|TWO_SIDED|95.0|-7.61|6.55||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 20||6.55|-7.61|0.882
71138148|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|-0.1||||0.982|TWO_SIDED|95.0|-7.92|7.75||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 20||7.75|-7.92|0.982
71138149|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|2.2||||0.673|TWO_SIDED|95.0|-8.11|12.51||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 28||12.51|-8.11|0.673
71138150|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|2.7||||0.467|TWO_SIDED|95.0|-4.64|10.04||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 28||10.04|-4.64|0.467
71138151|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|2.2||||0.583|TWO_SIDED|95.0|-5.79|10.23||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 28||10.23|-5.79|0.583
71138152|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|5.5||||0.564|TWO_SIDED|95.0|-13.33|24.31||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 36||24.31|-13.33|0.564
71138153|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|-2.4||||0.728|TWO_SIDED|95.0|-15.74|11.04||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 36||11.04|-15.74|0.728
71138154|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|5.5||||0.46|TWO_SIDED|95.0|-9.16|20.08||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 36||20.08|-9.16|0.460
71138155|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|12.0||||0.253|TWO_SIDED|95.0|-8.72|32.75||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 44||32.75|-8.72|0.253
71138156|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|1.1||||0.884|TWO_SIDED|95.0|-13.67|15.84||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 44||15.84|-13.67|0.884
71138157|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|5.8||||0.474|TWO_SIDED|95.0|-10.28|21.95||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 44||21.95|-10.28|0.474
71138158|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|3.6||||0.727|TWO_SIDED|95.0|-17.03|24.3||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 52||24.30|-17.03|0.727
71138159|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|2.1||||0.78|TWO_SIDED|95.0|-12.63|16.78||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 52||16.78|-12.63|0.780
71138160|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|6.5||||0.424|TWO_SIDED|95.0|-9.57|22.54||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 52||22.54|-9.57|0.424
71138161|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|-1.3||||0.841|TWO_SIDED|95.0|-14.23|11.62||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 20||11.62|-14.23|0.841
71138162|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|-2.1||||0.702|TWO_SIDED|95.0|-12.94|8.75||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 20||8.75|-12.94|0.702
71138163|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|5.7||||0.353|TWO_SIDED|95.0|-6.43|17.83||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 20||17.83|-6.43|0.353
71138164|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|2.1||||0.77|TWO_SIDED|95.0|-11.89|16.0||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 28||16.00|-11.89|0.770
71138165|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|-5.3||||0.367|TWO_SIDED|95.0|-17.04|6.37||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 28||6.37|-17.04|0.367
71138166|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|7.0||||0.291|TWO_SIDED|95.0|-6.09|20.07||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 28||20.07|-6.09|0.291
71138167|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|-0.7||||0.942|TWO_SIDED|95.0|-20.87|19.4||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 36||19.40|-20.87|0.942
71138168|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|-12.0||||0.162|TWO_SIDED|95.0|-28.89|4.91||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 36||4.91|-28.89|0.162
71138169|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|10.9||||0.253|TWO_SIDED|95.0|-7.96|29.82||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 36||29.82|-7.96|0.253
71138170|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|5.5||||0.617|TWO_SIDED|95.0|-16.25|27.21||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 44||27.21|-16.25|0.617
71138171|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|-6.0||||0.515|TWO_SIDED|95.0|-24.22|12.24||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 44||12.24|-24.22|0.515
71138172|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|13.8||||0.18|TWO_SIDED|95.0|-6.53|34.23||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 44||34.23|-6.53|0.180
71138173|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|-0.4||||0.972|TWO_SIDED|95.0|-21.86|21.09||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 52||21.09|-21.86|0.972
71138174|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|-4.9||||0.589|TWO_SIDED|95.0|-22.94|13.1||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 52||13.10|-22.94|0.589
71138175|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|14.1||||0.168|TWO_SIDED|95.0|-6.07|34.22||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 52||34.22|-6.07|0.168
71138176|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|1.9||||0.712|TWO_SIDED|95.0|-8.5|12.36||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 20||12.36|-8.50|0.712
71138177|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|-2.3||||0.465|TWO_SIDED|95.0|-8.41|3.9||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 20||3.90|-8.41|0.465
71138178|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|0.3||||0.924|TWO_SIDED|95.0|-6.83|7.52||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 20||7.52|-6.83|0.924
71138179|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|0.4||||0.938|TWO_SIDED|95.0|-8.88|9.6||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 28||9.60|-8.88|0.938
71138180|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|2.2||||0.41|TWO_SIDED|95.0|-3.17|7.64||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 28||7.64|-3.17|0.410
71138181|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|0.2||||0.941|TWO_SIDED|95.0|-5.89|6.35||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 28||6.35|-5.89|0.941
71138182|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|0.7||||0.872|TWO_SIDED|95.0|-8.23|9.67||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 36||9.67|-8.23|0.872
71138183|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|-1.0||||0.692|TWO_SIDED|95.0|-6.27|4.2||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 36||4.20|-6.27|0.692
71138184|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|-0.4||||0.896|TWO_SIDED|95.0|-6.32|5.54||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 36||5.54|-6.32|0.896
71138185|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|1.0||||0.826|TWO_SIDED|95.0|-7.92|9.87||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 44||9.87|-7.92|0.826
71138186|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|0.4||||0.885|TWO_SIDED|95.0|-4.82|5.58||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 44||5.58|-4.82|0.885
71138187|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|-0.1||||0.964|TWO_SIDED|95.0|-6.03|5.76||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 44||5.76|-6.03|0.964
71138188|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|1.1||||0.806|TWO_SIDED|95.0|-7.59|9.72||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 52||9.72|-7.59|0.806
71138189|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|0.4||||0.871|TWO_SIDED|95.0|-4.65|5.47||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 52||5.47|-4.65|0.871
71138190|NCT02365649|141776330|SUPERIORITY||LS Mean of Difference|-0.5||||0.85|TWO_SIDED|95.0|-6.28|5.19||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 52||5.19|-6.28|0.850
71138191|NCT02365649|141776331|SUPERIORITY||LS Mean of Difference|-3.9||||0.792|TWO_SIDED|95.0|-33.73|25.9||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||25.90|-33.73|0.792
71138192|NCT02365649|141776331|SUPERIORITY||LS Mean of Difference|18.1||||0.179|TWO_SIDED|95.0|-8.62|44.75||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||44.75|-8.62|0.179
71138193|NCT02365649|141776331|SUPERIORITY||LS Mean of Difference|-19.1||||0.23|TWO_SIDED|95.0|-50.87|12.63||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||12.63|-50.87|0.230
71138194|NCT02365649|141776331|SUPERIORITY||LS Mean of Difference|16.4||||0.337|TWO_SIDED|95.0|-17.54|50.4||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||50.40|-17.54|0.337
71138195|NCT02365649|141776331|SUPERIORITY||LS Mean of Difference|1.1||||0.924|TWO_SIDED|95.0|-21.75|23.93||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||23.93|-21.75|0.924
71138196|NCT02365649|141776331|SUPERIORITY||LS Mean of Difference|-11.7||||0.373|TWO_SIDED|95.0|-37.69|14.35||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||14.35|-37.69|0.373
71138197|NCT02365649|141776331|SUPERIORITY||LS Mean of Difference|-3.1||||0.813|TWO_SIDED|95.0|-28.94|22.79||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders||22.79|-28.94|0.813
71138198|NCT02365649|141776331|SUPERIORITY||LS Mean of Difference|5.3||||0.651|TWO_SIDED|95.0|-18.02|28.65||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders||28.65|-18.02|0.651
70864272|NCT02642029|141214122|OTHER||beta coefficient for anxiety|-0.00063||||0.284|TWO_SIDED|95.0|-0.00179|0.00052||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, anxiety). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00052|-0.00179|0.284
70864273|NCT02642029|141214123|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.755||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||0.755
70864274|NCT02642029|141214123|OTHER||beta coefficient for elated mood|-0.0007||||0.317|TWO_SIDED|95.0|-0.00208|0.00067||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, elated mood). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00067|-0.00208|0.317
70864275|NCT02642029|141214124|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.035||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||.035
70864276|NCT02642029|141214124|OTHER||beta coefficient for auditory hallucinat|0.00195||||0.028|TWO_SIDED|95.0|0.00021|0.00369||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, auditory hallucinations). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00369|0.00021|0.028
70864277|NCT02642029|141214125|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.748||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||.748
70864278|NCT02642029|141214125|OTHER||beta coefficient for visual hallucinatio|-0.00039||||0.685|TWO_SIDED|95.0|-0.0023|0.00151||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, visual hallucinations). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00151|-0.00230|0.685
70864279|NCT02642029|141214126|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.02||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||.020
70864280|NCT02642029|141214126|OTHER||beta coefficient for paranoid ideation|0.0004||||0.597|TWO_SIDED|95.0|-0.00108|0.00188||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, paranoid ideation). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00188|-0.00108|0.597
70864281|NCT02642029|141214127|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.237||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||.237
71138199|NCT02365649|141776331|SUPERIORITY||LS Mean of Difference|-23.8||||0.065|TWO_SIDED|95.0|-49.12|1.49||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.1 level.||Clinical responders||1.49|-49.12|0.065
71138200|NCT02365649|141776331|SUPERIORITY||LS Mean of Difference|5.3||||0.802|TWO_SIDED|95.0|-37.61|48.28||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||48.28|-37.61|0.802
71138201|NCT02365649|141776331|SUPERIORITY||LS Mean of Difference|0.6||||0.955|TWO_SIDED|95.0|-20.46|21.63||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||21.63|-20.46|0.955
71138202|NCT02365649|141776331|SUPERIORITY||LS Mean of Difference|-10.6||||0.395|TWO_SIDED|95.0|-35.73|14.47||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||14.47|-35.73|0.395
71138203|NCT02365649|141776332|SUPERIORITY||LS Mean of Difference|-0.0082||||0.893|TWO_SIDED|95.0|-0.1299|0.1136||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||0.1136|-0.1299|0.893
71138204|NCT02365649|141776332|SUPERIORITY||LS Mean of Difference|0.0685||||0.182|TWO_SIDED|95.0|-0.0334|0.1705||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||0.1705|-0.0334|0.182
71138205|NCT02365649|141776332|SUPERIORITY||LS Mean of Difference|-0.1323||||0.036|TWO_SIDED|95.0|-0.2552|-0.0093||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.05 level.||Responders||-0.0093|-0.2552|0.036
70864282|NCT02642029|141214127|OTHER||beta coefficient for ideas/del of refere|-0.00142||||0.178|TWO_SIDED|95.0|-0.0035|0.00065||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, ideas/delusions of reference). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00065|-0.00350|0.178
71138206|NCT02365649|141776332|SUPERIORITY||LS Mean of Difference|0.0768||||0.316|TWO_SIDED|95.0|-0.0749|0.2286||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||0.2286|-0.0749|0.316
71138207|NCT02365649|141776332|SUPERIORITY||LS Mean of Difference|0.0573||||0.277|TWO_SIDED|95.0|-0.0471|0.1617||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||0.1617|-0.0471|0.277
71138208|NCT02365649|141776332|SUPERIORITY||LS Mean of Difference|0.0428||||0.467|TWO_SIDED|95.0|-0.0741|0.1597||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||0.1597|-0.0741|0.467
71138209|NCT02365649|141776332|SUPERIORITY||LS Mean of Difference|-0.036||||0.464|TWO_SIDED|95.0|-0.1336|0.0616||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders||0.0616|-0.1336|0.464
71138210|NCT02365649|141776332|SUPERIORITY||LS Mean of Difference|0.0404||||0.345|TWO_SIDED|95.0|-0.0444|0.1252||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders||0.1252|-0.0444|0.345
71138211|NCT02365649|141776332|SUPERIORITY||LS Mean of Difference|-0.0873||||0.071|TWO_SIDED|95.0|-0.1822|0.0076||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.1 level.||Clinical responders||0.0076|-0.1822|0.071
71138212|NCT02365649|141776332|SUPERIORITY||LS Mean of Difference|0.1109||||0.317|TWO_SIDED|95.0|-0.1109|0.3326||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||0.3326|-0.1109|0.317
71138213|NCT02365649|141776332|SUPERIORITY||LS Mean of Difference|0.0848||||0.125|TWO_SIDED|95.0|-0.0248|0.1945||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||0.1945|-0.0248|0.125
71138214|NCT02365649|141776332|SUPERIORITY||LS Mean of Difference|0.0559||||0.39|TWO_SIDED|95.0|-0.0745|0.1864||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||0.1864|-0.0745|0.390
71138215|NCT02365649|141776333|SUPERIORITY||LS Mean of Difference|8.7||||0.263|TWO_SIDED|95.0|-6.79|24.16||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||24.16|-6.79|0.263
71138216|NCT02365649|141776333|SUPERIORITY||LS Mean of Difference|15.2||||0.031|TWO_SIDED|95.0|1.47|28.93||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.05 level.||Responders||28.93|1.47|0.031
71138217|NCT02365649|141776333|SUPERIORITY||LS Mean of Difference|-12.0||||0.135|TWO_SIDED|95.0|-27.93|3.9||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||3.90|-27.93|0.135
71138218|NCT02365649|141776333|SUPERIORITY||LS Mean of Difference|6.3||||0.458|TWO_SIDED|95.0|-10.61|23.27||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||23.27|-10.61|0.458
71138219|NCT02365649|141776333|SUPERIORITY||LS Mean of Difference|1.9||||0.738|TWO_SIDED|95.0|-9.59|13.45||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||13.45|-9.59|0.738
71138220|NCT02365649|141776333|SUPERIORITY||LS Mean of Difference|-5.4||||0.412|TWO_SIDED|95.0|-18.32|7.6||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||7.60|-18.32|0.412
71138221|NCT02365649|141776333|SUPERIORITY||LS Mean of Difference|3.9||||0.534|TWO_SIDED|95.0|-8.56|16.36||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders||16.36|-8.56|0.534
71138222|NCT02365649|141776333|SUPERIORITY||LS Mean of Difference|11.0||||0.052|TWO_SIDED|95.0|-0.1|22.01||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.1 level.||Clinical responders||22.01|-0.10|0.052
71138223|NCT02365649|141776333|SUPERIORITY||LS Mean of Difference|-13.9||||0.027|TWO_SIDED|95.0|-26.15|-1.63||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.05 level.||Clinical responders||-1.63|-26.15|0.027
71138224|NCT02365649|141776333|SUPERIORITY||LS Mean of Difference|-1.0||||0.928|TWO_SIDED|95.0|-24.02|21.97||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||21.97|-24.02|0.928
71138225|NCT02365649|141776333|SUPERIORITY||LS Mean of Difference|-2.5||||0.658|TWO_SIDED|95.0|-13.72|8.77||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||8.77|-13.72|0.658
71138226|NCT02365649|141776333|SUPERIORITY||LS Mean of Difference|-3.5||||0.601|TWO_SIDED|95.0|-16.96|9.96||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||9.96|-16.96|0.601
71138227|NCT02365649|141776335|SUPERIORITY||Risk Difference (RD)|-50.0||||1|TWO_SIDED|95.0|-99.0|-1.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||-1.0|-99.0|1.000
71138228|NCT02365649|141776335|SUPERIORITY||Risk Difference (RD)|-25.0||||1|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical Responders||5.0|-55.0|1.000
71138229|NCT02365649|141776335|SUPERIORITY||Risk Difference (RD)|-25.0||||1|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical Responders||5.0|-55.0|1.000
71138230|NCT02365649|141776335|SUPERIORITY||Risk Difference (RD)|-25.0||||1|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical Responders||5.0|-55.0|1.000
71138231|NCT02365649|141776336|SUPERIORITY||Risk Difference (RD)|-66.7||||1|TWO_SIDED|95.0|-100.0|-13.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||-13.3|-100.0|1.000
71138232|NCT02365649|141776336|SUPERIORITY||Risk Difference (RD)|33.3||||0.25|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||86.7|-20.0|0.250
71138233|NCT02365649|141776336|SUPERIORITY||Risk Difference (RD)|16.7||||1|TWO_SIDED|95.0|-62.2|95.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||95.6|-62.2|1.000
71138234|NCT02365649|141776336|SUPERIORITY||Risk Difference (RD)|-33.3||||0.5|TWO_SIDED|95.0|-71.1|4.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||4.4|-71.1|0.500
71138235|NCT02365649|141776336|SUPERIORITY||Risk Difference (RD)|-33.3||||1|TWO_SIDED|95.0|-71.1|4.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||4.4|-71.1|1.000
71138236|NCT03863509|141776442|OTHER|||||||0.494|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 384) = 0.707, p = .494||||||.494
70864283|NCT02642029|141214128|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.33||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||.330
70864284|NCT02642029|141214128|OTHER||beta coefficient for delusions of contro|-0.00038||||0.777|TWO_SIDED|95.0|-0.00305|0.00228||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, delusions of control). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00228|-0.00305|0.777
71138237|NCT03863509|141776443|OTHER|||||||0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference F(2, 381) = 7.409, p = .001||||||0.001
71138238|NCT03863509|141776443|OTHER||Mean Difference (Final Values)|-0.42||||0.822|TWO_SIDED|95.0|-4.08|3.24|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race/ethnicity were covaried.||these are pairwise follow-up tests probing a larger omnibus group difference involving three groups.||3.240|-4.080|0.822
71138239|NCT03863509|141776443|OTHER||Mean Difference (Final Values)|7.267||||0.001|TWO_SIDED|95.0|2.974|11.559|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||these are pairwise follow-up tests probing a larger omnibus group difference involving three groups.||11.559|2.974|0.001
71138240|NCT03863509|141776443|OTHER||Mean Difference (Final Values)|7.687|||<|0.001|TWO_SIDED|95.0|3.485|11.889|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||These are pairwise follow-up tests probing a larger omnibus group difference involving three groups.||11.889|3.485|<0.001
71138241|NCT03863509|141776444|OTHER|||||||0.074||||||Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 386) = 2.616, p = .074|ANCOVA|||||||.074
70864285|NCT01050543|141214149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.1|||<|0.0001|TWO_SIDED|95.0|6.8|9.6|||ANOVA|||To evaluate the efficacy of sugammadex compared to the efficacy of neostigmine, the ratio of the geometric means of time to recovery of the T4/T1 ratio to 0.9 was calculated using a 2-way ANOVA model adjusted for trial site.||9.6|6.8|<0.0001
70864286|NCT00676338|141214150|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority Null Hypotheses: H1: The effect of exenatide is inferior to that of metformin. H2: The effect of exenatide is inferior to that of sitagliptin. H3: The effect of exenatide is inferior to that of pioglitazone. Then, the 3 superiority null hypotheses were tested. Change in HbA1c was analyzed using an MMRM analysis of covariance (ANCOVA) with treatment, baseline HbA1c, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|Least Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.09||0.62|TWO_SIDED|98.3|-0.26|0.17||Noninferiority was tested by Bonferroni (margin 0.3%, adjusted significance of 0.0167). Superiority was tested by Hommel (nominal significance level was between 0.0167 and 0.05 depended on the number of noninferiority hypotheses rejected).|Mixed Models Analysis|||Power calculation: A sample of 740 (222 exenatide once weekly, 222 metformin, 148 pioglitazone, and 148 sitagliptin) would provide approximately 90% power to detect a true differences between exenatide once weekly and the 3 comparators: metformin, pioglitazone, and sitagliptin of 0.4%, 0.5%, and 0.5%, respectively in change in HbA1c from baseline to Week 26 with a 2-sided t test at a significance level of 0.05, assuming a common standard deviation of 1.2%.||0.17|-0.26|0.620
70864287|NCT00676338|141214150|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority Null Hypotheses: H1: The effect of exenatide is inferior to that of metformin. H2: The effect of exenatide is inferior to that of sitagliptin. H3: The effect of exenatide is inferior to that of pioglitazone. Then, the 3 superiority null hypotheses were tested. Change in HbA1c was analyzed using an MMRM analysis of covariance (ANCOVA) with treatment, baseline HbA1c, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.328|TWO_SIDED|98.3|-0.15|0.35||Noninferiority was tested by Bonferroni (margin 0.3%, adjusted significance of 0.0167). Superiority was tested by Hommel (nominal significance level was between 0.0167 and 0.05 depended on the number of noninferiority hypotheses rejected).|Mixed Models Analysis|||Power calculation: A sample of 740 (222 exenatide once weekly, 222 metformin, 148 pioglitazone, and 148 sitagliptin) would provide approximately 90% power to detect a true differences between exenatide once weekly and the 3 comparators: metformin, pioglitazone, and sitagliptin of 0.4%, 0.5%, and 0.5%, respectively in change in HbA1c from baseline to Week 26 with a 2-sided t test at a significance level of 0.05, assuming a common standard deviation of 1.2%.||0.35|-0.15|0.328
71138242|NCT03863509|141776445|OTHER||Type III F-test of Fixed Group x Time ef|6.609||||0.002|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Omnibus Group x Time (pre-post) interaction test: F (2, 378.467) = 6.609, p = .002. Age, race, and sex were covaried.|F (2, 378.467) = 6.609, p = .002|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||.002
71138243|NCT03863509|141776445|OTHER||interaction estimate|3.3|STANDARD_ERROR_OF_MEAN|0.99||0.001|TWO_SIDED|95.0|1.36|5.24|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in systolic blood pressure, adjusting for age, sex, and race. Here presented the Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||5.24|1.36|0.001
71138244|NCT03863509|141776445|OTHER||interaction term estimate|3.29|STANDARD_ERROR_OF_MEAN|1.06||0.002|TWO_SIDED|95.0|1.2|5.38|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in systolic blood pressure, adjusting for age, sex, and race. Here presented the Exclusive cigarette smokers x Time vs never users x time as reference|||5.38|1.20|0.002
71138245|NCT03863509|141776445|OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.948||0.992|TWO_SIDED||||||ANCOVA|||||||.992
71138246|NCT03863509|141776446|OTHER||Type III F-test of Fixed Group x Time ef|5.843||||0.003|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 378.999) = 5.843, p = .003|F (2, 378.999) = 5.843, p = .003|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||0.003
71138247|NCT03863509|141776446|OTHER||Interaction term Coefficient|0.03|STANDARD_ERROR_OF_MEAN|0.01||0.002|TWO_SIDED|95.0|0.01|0.05|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in diastolic blood pressure, adjusting for age, sex, and race. Here presented the Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||0.05|0.01|.002
71138248|NCT03863509|141776446|OTHER||Interaction term Coefficient|0.03|STANDARD_ERROR_OF_MEAN|0.01||0.003|TWO_SIDED|95.0|0.01|0.05|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in diastolic blood pressure, adjusting for age, sex, and race. Here presented the Exclusive Smokers x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||0.05|0.01|.003
71138249|NCT03863509|141776446|OTHER||Interaction term Coefficient|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.917|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in diastolic blood pressure, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||||.917
71138250|NCT03863509|141776447|OTHER||Type III F-test of Fixed Group x Time Ef|49.42|||<|0.001|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 376.099) = 49.420, p \< .001|F (2, 376.099) = 49.420, p \< .001|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||< .001
70872182|NCT02495168|141229588|EQUIVALENCE|To show the clinical equivalence, an analysis of covariance (ANCOVA) model was fit on the participants from the generic budesonide/formoterol fumarate and Symbicort groups only, with the endpoint as outcome and treatment, study site and treatment by site interaction as fixed effects and FEV1 baseline value as covariate. If the treatment-by-site interaction factor was not significant at the 0.05 level, the model was to be rerun without the interaction term.|Test/Referece LS Mean Ratio|101.9|||||TWO_SIDED|90.0|92.7|111.9|||||Fieller's formula was applied to calculate the 90% confidence interval (CI) for the generic budesonide/formoterol fumarate and Symbicort LS mean ratio; covariance between treatment means was assumed to be 0.|||111.9|92.7|
70872183|NCT02495168|141229589|SUPERIORITY||LS Mean Difference|2.334|||<|0.0001|TWO_SIDED|95.0|1.673|2.996||Threshold for significance at 0.05 level.|ANCOVA|||LS means difference and p-value from ANCOVA model with treatment and site as fixed effects, baseline FEV1 as covariate and endpoint as outcome on generic budesonide/formoterol fumarate dihydrate and Placebo participants only.||2.996|1.673|<0.0001
70864288|NCT00676338|141214150|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority Null Hypotheses: H1: The effect of exenatide is inferior to that of metformin. H2: The effect of exenatide is inferior to that of sitagliptin. H3: The effect of exenatide is inferior to that of pioglitazone. Then, the 3 superiority null hypotheses were tested. Change in HbA1c was analyzed using an MMRM analysis of covariance (ANCOVA) with treatment, baseline HbA1c, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|Least Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|98.3|-0.62|-0.13||Noninferiority was tested by Bonferroni (margin 0.3%, adjusted significance of 0.0167). Superiority was tested by Hommel (nominal significance level was between 0.0167 and 0.05 depended on the number of noninferiority hypotheses rejected).|Mixed Models Analysis|||Power calculation: A sample of 740 (222 exenatide once weekly, 222 metformin, 148 pioglitazone, and 148 sitagliptin) would provide approximately 90% power to detect a true differences between exenatide once weekly and the 3 comparators: metformin, pioglitazone, and sitagliptin of 0.4%, 0.5%, and 0.5%, respectively in change in HbA1c from baseline to Week 26 with a 2-sided t test at a significance level of 0.05, assuming a common standard deviation of 1.2%.||-0.13|-0.62|<.001
70864289|NCT00676338|141214151|SUPERIORITY_OR_OTHER|||||||0.151|TWO_SIDED|||||No multiple adjustment were done.|Fisher Exact|||||||0.151
70864290|NCT00676338|141214151|SUPERIORITY_OR_OTHER|||||||0.913|TWO_SIDED|||||No multiple adjustment were done.|Fisher Exact|||||||0.913
70864291|NCT00676338|141214151|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||No multiple adjustment were done.|Fisher Exact|||||||<.001
70864292|NCT00676338|141214152|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.19||0.155|TWO_SIDED|95.0|-0.66|0.1||No multiple adjustment were done.|Mixed Models Analysis|||Change in FSG from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline FSG, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||0.10|-0.66|0.155
70864293|NCT00676338|141214152|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.22||0.153|TWO_SIDED|95.0|-0.12|0.75||No multiple adjustment were done.|Mixed Models Analysis|||Change in FSG from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline FSG, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||0.75|-0.12|0.153
70864294|NCT00676338|141214152|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.12|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|-1.56|-0.68||No multiple adjustment were done.|Mixed Models Analysis|||Change in FSG from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline FSG, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-0.68|-1.56|<.001
70864295|NCT00676338|141214153|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.29||0.892|TWO_SIDED|95.0|-0.61|0.53||No multiple adjustment were done.|Mixed Models Analysis|||Change in Body Weight from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline body weight, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||0.53|-0.61|0.892
70864296|NCT00676338|141214153|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.56|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|95.0|-4.21|-2.9||No multiple adjustment were done.|Mixed Models Analysis|||Change in Body Weight from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline body weight, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-2.90|-4.21|<.001
70864297|NCT00676338|141214153|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.28|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|95.0|-1.92|-0.63||No multiple adjustment were done.|Mixed Models Analysis|||Change in Body Weight from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline body weight, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-0.63|-1.92|<.001
70864298|NCT00676338|141214154|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.08||0.873|TWO_SIDED|95.0|-0.18|0.15||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting TC from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline TC, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||0.15|-0.18|0.873
70864299|NCT00676338|141214154|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.52|-0.14||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting TC from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline TC, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-0.14|-0.52|<.001
71138251|NCT03863509|141776447|OTHER||interaction term coefficient|6.06|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|4.83|7.3|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in Heart Rate, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||7.3|4.83|<0.001
71138252|NCT03863509|141776447|OTHER||interaction term coefficient|5.09|STANDARD_ERROR_OF_MEAN|0.68|<|0.001|TWO_SIDED|95.0|3.76|6.42|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in Heart Rate, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||6.42|3.76|<0.001
71138253|NCT03863509|141776447|OTHER||interaction term coefficient|-0.97|STANDARD_ERROR_OF_MEAN|0.602||0.107|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in Heart Rate, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.107
71138254|NCT03863509|141776448|OTHER||Type III F-test of Fixed Group x Time Ef|6.194||||0.002|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2,372.971) = 6.194, p = .002|F (2,372.971) = 6.194, p = .002|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use.||||0.002
71138255|NCT03863509|141776448|OTHER||interaction term coefficient|-0.005|STANDARD_ERROR_OF_MEAN|0.001||0.003|TWO_SIDED|95.0|-0.01|-0.002|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in Brachial Artery Diameter, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||-0.002|-0.01|0.003
71138256|NCT03863509|141776448|OTHER||interaction term coefficient|-0.01|STANDARD_ERROR_OF_MEAN|0.002||0.001|TWO_SIDED|95.0|-0.01|-0.002|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in Brachial Artery Diameter, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||-0.002|-0.01|0.001
71138257|NCT03863509|141776448|OTHER||interaction term coefficient|-0.001|STANDARD_ERROR_OF_MEAN|0.002||0.582|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in Brachial Artery Diameter, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.582
71138258|NCT03863509|141776449|OTHER||Type III F-test of Fixed Group x Time E|1.753||||0.175|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests|Mixed Models Analysis|Age, race, and sex were covaried.|FMD responses in e-cigarette users, cigarette users, and never-users controls after adjusting for changes in brachial artery diameter.|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||0.175
71138259|NCT03863509|141776449|OTHER||interaction term coefficient|0.75|STANDARD_ERROR_OF_MEAN|0.41||0.067|TWO_SIDED|95.0|-0.05|1.56|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in Brachial Artery Flow Mediated Dilation, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||1.56|-0.05|0.067
71138260|NCT03863509|141776449|OTHER||interaction term coefficient|0.33|STANDARD_ERROR_OF_MEAN|0.44||0.464|TWO_SIDED|95.0|-0.55|1.2|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in Brachial Artery Flow Mediated Dilation, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||1.20|-0.55|0.464
71138261|NCT03863509|141776449|OTHER||interaction term coefficient|-0.43|STANDARD_ERROR_OF_MEAN|0.4||0.284|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing effects of group, time, and group x time in FMD, age, sex, race adjusted, for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.284
71138262|NCT03863509|141776450|OTHER||Type III F-test of Fixed Group x Time Ef|8.323|||<|0.001|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 342.847) = 8.323, p = \<.001|F (2,342.847) = 8.323, p = \<.001|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||<0.001
70864300|NCT00676338|141214154|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.1||0.022|TWO_SIDED|95.0|-0.41|-0.03||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting TC from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline TC, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-0.03|-0.41|0.022
70864301|NCT00676338|141214155|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.02||0.004|TWO_SIDED|95.0|-0.09|-0.02||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting HDL from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline HDL, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-0.02|-0.09|0.004
71138263|NCT03863509|141776450|OTHER||interaction term coefficient|-6.55|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-9.89|-3.2|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in PNN50, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||-3.20|-9.89|<0.001
70864302|NCT00676338|141214155|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|95.0|-0.19|-0.11||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting HDL from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline HDL, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-0.11|-0.19|<.001
70864303|NCT00676338|141214155|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.02||0.142|TWO_SIDED|95.0|-0.07|0.01||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting HDL from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline HDL, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||0.01|-0.07|0.142
70864304|NCT00676338|141214156|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.04||0.657|TWO_SIDED|95.0|0.94|1.1||No multiple adjustment were done.|ANCOVA|||Fasting triglycerides data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using ANCOVA model with treatment and country as factors and baseline triglycerides as a covariate.||1.10|0.94|0.657
71138264|NCT03863509|141776450|OTHER||interaction term coefficient|-6.11|STANDARD_ERROR_OF_MEAN|1.83||0.001|TWO_SIDED|95.0|-9.71|-2.52|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in PNN50, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||-2.52|-9.71|0.001
71138265|NCT03863509|141776450|OTHER||interaction term coefficient|0.44|STANDARD_ERROR_OF_MEAN|1.61||0.787|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in PNN50, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.787
71138266|NCT03863509|141776451|OTHER||Type III F-test of Fixed Group x Time Ef|7.26||||0.001|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 345.918) = 7.260, p = .001|F (2,345.918) = 7.260, p = .001|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use Outcome measure ln transformed for analysis.||||0.001
71138267|NCT03863509|141776451|OTHER||interaction term coefficient|-0.2|STANDARD_ERROR_OF_MEAN|0.06||0.001|TWO_SIDED|95.0|-0.31|-0.08|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in RMSSD, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||-0.08|-0.31|0.001
71138268|NCT03863509|141776451|OTHER||interaction term coefficient|-0.21|STANDARD_ERROR_OF_MEAN|0.06||0.001|TWO_SIDED|95.0|-0.33|-0.09|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in RMSSD, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||-0.09|-0.33|0.001
71138269|NCT03863509|141776451|OTHER||interaction term coefficient|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.847|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in RMSSD, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.847
71138270|NCT03863509|141776452|OTHER||Type III F-test of Fixed Group x Time Ef|1.712||||0.182|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 312.081) = 1.712, p = .182|F (2, 312.081) = 1.712, p = .182|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||.182
71138271|NCT03863509|141776452|OTHER||interaction term coefficient|-0.04|STANDARD_ERROR_OF_MEAN|0.02||0.07|TWO_SIDED|95.0|-0.09|0.004|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in HRV-Standing Ratio, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|||0.004|-0.09|0.07
71138272|NCT03863509|141776452|OTHER||interaction term coefficient|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.196|TWO_SIDED|95.0|-0.09|0.02|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in HRV-Standing Ratio adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||0.02|-0.09|0.196
70864305|NCT00676338|141214156|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|1.16|STANDARD_ERROR_OF_MEAN|0.05||0.002|TWO_SIDED|95.0|1.06|1.27||No multiple adjustment were done.|ANCOVA|||Fasting triglycerides data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using ANCOVA model with treatment and country as factors and baseline triglycerides as a covariate.||1.27|1.06|0.002
71138273|NCT03863509|141776452|OTHER||interaction term coefficient|0.09|STANDARD_ERROR_OF_MEAN|0.02||0.69|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in HRV-Standing Ratio adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.69
71138274|NCT03863509|141776453|OTHER||Type III F-test of Fixed Group x Time Ef|4.096||||0.017|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 373.239) = 4.096, p = .017|F (2, 373.239) = 4.096, p = .017|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use.||||0.017
71138275|NCT03863509|141776453|OTHER||interaction term coefficient|-3.04|STANDARD_ERROR_OF_MEAN|1.09||0.005|TWO_SIDED|95.0|-5.18|-0.91|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FEV1, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|||-0.91|-5.18|0.005
71138276|NCT03863509|141776453|OTHER||interaction term coefficient|-1.29|STANDARD_ERROR_OF_MEAN|1.18||0.274|TWO_SIDED|95.0|-3.61|1.03|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FEV1, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||1.03|-3.61|0.274
71138277|NCT03863509|141776453|OTHER||interaction term coefficient|1.75|STANDARD_ERROR_OF_MEAN|1.06||0.098|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in FEV1, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.098
71138278|NCT03863509|141776454|OTHER||Type III F-test of Fixed Group x Time Ef|0.26||||0.771|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 373.434) = 0.260, p = .771|F (2, 373.434) = 0.260, p = .771|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use.||||.771
71138279|NCT03863509|141776454|OTHER||interaction term coefficient|-0.12|STANDARD_ERROR_OF_MEAN|1.14||0.918|TWO_SIDED|95.0|-2.35|2.12|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FVC, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||2.12|-2.35|0.918
71138280|NCT03863509|141776454|OTHER||interaction term coefficient|-0.8|STANDARD_ERROR_OF_MEAN|1.23||0.518|TWO_SIDED|95.0|-3.22|1.63|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FVC, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||1.63|-3.22|0.518
71138281|NCT03863509|141776454|OTHER||interaction term coefficient|-0.68|STANDARD_ERROR_OF_MEAN|1.11||0.539|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in FVC, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.539
71138282|NCT03863509|141776455|OTHER||Type III F-test of Fixed Group x Time Ef|7.157||||0.001|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 375.412) = 7.157, p = .001|F (2, 375.412) = 7.157, p = .001|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use.||||0.001
71138283|NCT03863509|141776455|OTHER||interaction term coefficient|-3.39|STANDARD_ERROR_OF_MEAN|1.04||0.001|TWO_SIDED|95.0|-5.43|-1.35|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FEV1/FVC, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|||-1.35|-5.43|0.001
71138284|NCT03863509|141776455|OTHER||interaction term coefficient|-0.32|STANDARD_ERROR_OF_MEAN|1.12||0.778|TWO_SIDED|95.0|-2.53|1.89|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FEV1/FVC, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||1.89|-2.53|0.778
71138285|NCT03863509|141776455|OTHER||interaction term coefficient|3.08|STANDARD_ERROR_OF_MEAN|1.08||0.002|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in FEV1/FVC, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.002
71138286|NCT03863509|141776456|OTHER||Type III F-test of Fixed Group x Time Ef|4.317||||0.014|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 373.170) = 4.317, p = .014|F (2, 373.170) = 4.317, p = .014|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||0.014
71138287|NCT03863509|141776456|OTHER||interaction term coefficient|-5.08|STANDARD_ERROR_OF_MEAN|2.1||0.016|TWO_SIDED|95.0|-9.21|-0.95|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FEF 25-75, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||-0.95|-9.21|0.016
71138288|NCT03863509|141776456|OTHER||interaction term coefficient|0.01|STANDARD_ERROR_OF_MEAN|2.28||0.998|TWO_SIDED|95.0|-4.47|4.48|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FEF 25-75, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||4.48|-4.47|0.998
71138289|NCT03863509|141776456|OTHER||interaction term coefficient|5.09|STANDARD_ERROR_OF_MEAN|2.04||0.013|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in FEF 25-75, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.013
71138290|NCT03863509|141776457|OTHER||Type III F-test of Fixed Group x Time Ef|6.694||||0.001|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2,376.779) = 6.694, p = .001|F ((2,376.779) = 6.694, p = .001|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and-between-group responses following product use Outcome measure ln transformed for analysis.||||0.001
71138291|NCT03863509|141776457|OTHER||interaction term coefficient|-0.09|STANDARD_ERROR_OF_MEAN|0.03||0.001|TWO_SIDED|95.0|-0.14|-0.04|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FeNO, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||-0.04|-0.14|0.001
71138292|NCT03863509|141776457|OTHER||interaction term coefficient|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.555|TWO_SIDED|95.0|-0.08|0.04|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FeNO, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||0.04|-0.08|0.555
71138293|NCT03863509|141776457|OTHER||interaction term coefficient|0.007|STANDARD_ERROR_OF_MEAN|0.03||0.007|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in FeNO, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.007
71138294|NCT03863509|141776458|OTHER||||||<|0.001||||||ANCOVA for group differences|ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 386) = 12.869, p \< .001||||||< .001
71138295|NCT03863509|141776458|OTHER||Mean Difference (Final Values)|1.352||||0.269|TWO_SIDED|95.0|-1.048|3.752|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||Never Users minus Exclusive E-Cig Users||3.752|-1.048|0.269
71138296|NCT03863509|141776458|OTHER||Mean Difference (Final Values)|-5.575|||<|0.001|TWO_SIDED|95.0|-8.37|-2.78|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||Never Users minus Exclusive Smokers||-2.780|-8.37|<0.001
71138297|NCT03863509|141776458|OTHER||Mean Difference (Final Values)|-6.927|||<|0.001|TWO_SIDED|95.0|-9.672|-4.183|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried.||Exclusive E-Cig Users minus Exclusive Smokers||-4.183|-9.672|<0.001
71138298|NCT03863509|141776459|OTHER|||||||0.035|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 361) = 3.392, p = .035|||Group difference did not survive correction for false discovery rate at .05, therefore not followed with post-hoc pairwise comparisons.|||.035
71138299|NCT03863509|141776460|OTHER|||||||0.549|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 386) = 0.601, p = .549||||||.549
71138300|NCT03863509|141776461|OTHER|||||||0.022|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 381) = 3.877, p = .022|||Group difference tested after correction for false discovery rate at .05, therefore we followed with post-hoc pairwise comparisons.|||.022
71138301|NCT03863509|141776461|OTHER|||||||0.952|||||||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||Never Users minus Exclusive E-Cig Users||||0.952
71138302|NCT03863509|141776461|OTHER|||||||0.014|||||||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||post hoc pairwise group comparisons.. Never Users minus Exclusive Smokers||||0.014
71138303|NCT03863509|141776461|OTHER|||||||0.011||||||Age, sex, and race were covaried|ANCOVA post-hoc pairwise group compariso|||Exclusive E-Cig Users minus Exclusive Smokers||||0.011
71138304|NCT03863509|141776462|OTHER||||||<|0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Outcome variable log-transformed for analysis. Test for group difference: F (2, 381) = 33.442, p \< .001|||Group difference tested for false discovery rate at .05 and followed with post-hoc pairwise comparisons.|||< .001
71138305|NCT03863509|141776462|OTHER||Mean Difference (Final Values)|0.18||||0.013|TWO_SIDED|95.0|0.039|0.322|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried|Estimated marginal mean differences (log-transformed scale)|Never Users minus Exclusive E-Cig Users:||0.322|0.039|0.013
71138306|NCT03863509|141776462|OTHER||Mean Difference (Final Values)|0.679|||<|0.001|TWO_SIDED|95.0|0.514|0.844|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried|Estimated marginal mean differences (log-transformed scale)|Never Users minus Exclusive Smokers||0.844|0.514|<0.001
71138307|NCT03863509|141776462|OTHER||Mean Difference (Final Values)|0.498|||<|0.001|TWO_SIDED|95.0|0.336|0.66|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race/ethnicity were covaried|"Estimated marginal mean differences (log-transformed scale)"|Exclusive E-Cig users minus Exclusive Smokers||0.660|0.336|<0.001
71138308|NCT03863509|141776463|OTHER|||||||0.15|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 361) = 1.904, p = .150||||||.150
71138309|NCT03863509|141776464|OTHER||||||<|0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 385) = 17.872, p \< .001|||Group difference tested for false discovery rate at .05, and followed with post-hoc pairwise comparisons. Estimated marginal mean differences:|||< .001
71138310|NCT03863509|141776464|OTHER||Mean Difference (Final Values)|-3.632||||0.003|TWO_SIDED|95.0|-6.019|-1.245|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||Never Users minus Exclusive E-Cig Users||-1.245|-6.019|0.003
71138311|NCT03863509|141776464|OTHER||Mean Difference (Final Values)|-8.38|||<|0.001|TWO_SIDED|95.0|-11.14|-5.62|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||Never Users minus Exclusive Smokers||-5.62|-11.14|<0.001
71138312|NCT03863509|141776464|OTHER||Mean Difference (Final Values)|-4.748||||0.001|TWO_SIDED|95.0|-7.456|-2.04|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||Exclusive E-Cig Users minus Exclusive Smokers||-2.040|-7.456|0.001
71138313|NCT03863509|141776465|OTHER||||||<|0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 343) = 17.056, p \< .001|||Group difference tested for false discovery rate at .05, and followed with post-hoc pairwise comparisons.|||< .001
71138314|NCT03863509|141776465|OTHER||Mean Difference (Final Values)|1.279|||<|0.001|TWO_SIDED|95.0|0.733|1.824|||ANCOVA post-hoc pairwise group compariso|age, sex and race were covaried||Never Users minus Exclusive E-Cig Users||1.824|0.733|<0.001
71138315|NCT03863509|141776465|OTHER||Mean Difference (Final Values)|1.739|||<|0.001|TWO_SIDED|95.0|1.083|2.395|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||Never Users minus Exclusive Smokers||2.395|1.083|<0.001
71138316|NCT03863509|141776465|OTHER||Mean Difference (Final Values)|0.46||||0.165|TWO_SIDED|95.0|-0.19|1.11|||ANCOVA post-hoc pairwise group compariso|age, sex and race were covaried||Exclusive E-Cig Users minus Exclusive Smokers||1.110|-0.190|0.165
71138317|NCT03863509|141776466|OTHER|||||||0.199|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 386) = 1.621, p = .199||||||.199
71138318|NCT03863509|141776467|OTHER||||||<|0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 343) = 17.056, p\< .001|||Group difference tested for false discovery rate at .05, and followed with post-hoc pairwise comparisons.|||<0.001
71138319|NCT03863509|141776467|OTHER||Mean Difference (Final Values)|1.279|||<|0.001|TWO_SIDED|95.0|0.733|1.824|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||Never Users minus Exclusive E-Cig users||1.824|0.733|<0.001
71138320|NCT03863509|141776467|OTHER||Mean Difference (Final Values)|1.739|||<|0.001|TWO_SIDED|95.0|1.083|2.395|||ANCOVA post-hoc pairwise group compariso|age, sex, race covaried||Never Users minus Exclusive Smokers||2.395|1.083|<0.001
71138321|NCT03863509|141776467|OTHER||Mean Difference (Final Values)|0.46||||0.165|TWO_SIDED|95.0|-0.19|1.11|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||Exclusive E-Cig Users minus Exclusive Smokers||1.110|-0.190|0.165
71138322|NCT03863509|141776468|OTHER||||||<|0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 343) = 17.056, p\< .001|||Group difference tested for false discovery rate at .05, and followed with post-hoc pairwise comparisons.|||<0.001
71138323|NCT03863509|141776468|OTHER||Mean Difference (Final Values)|1.279|||<|0.001|TWO_SIDED|95.0|0.733|1.824|||ANCOVA post-hoc pairwise group compariso|Age, sex, race were covaried||Never Users minus Exclusive E-Cig Users||1.824|0.733|<0.001
71138324|NCT03863509|141776468|OTHER||Mean Difference (Final Values)|1.739|||<|0.001|TWO_SIDED|95.0|1.083|2.395|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||Never Users minus Exclusive Smokers||2.395|1.083|<0.001
71138325|NCT03863509|141776468|OTHER||Mean Difference (Final Values)|0.46||||0.165|TWO_SIDED|95.0|-0.19|1.11|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||Exclusive E-Cig Users minus Exclusive Smokers||1.110|-0.190|0.165
71138326|NCT03863509|141776469|OTHER||||||<|0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 344) = 10.075, p \< .001|||Group difference tested for false discovery rate at .05, and followed with post-hoc pairwise comparisons. Estimated marginal mean differences:|||<0.001
71138327|NCT06172348|141776479|OTHER||Ratio of Adjusted Geometric Means|21.89|||||TWO_SIDED|90.0|19.31|24.8|||||Ratios (Test/Reference) and 90 percent (%) confidence intervals were expressed as percentages. Test = MR1 capsule; Reference = Oral solution.|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||24.80|19.31|
71138328|NCT06172348|141776479|OTHER||Ratio of Adjusted Geometric Means|12.65|||||TWO_SIDED|90.0|11.21|14.27|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR2 capsule; Reference = Oral solution.|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||14.27|11.21|
71138329|NCT06172348|141776480|OTHER||Ratio of Adjusted Geometric Means|86.49|||||TWO_SIDED|90.0|79.11|94.54|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR1 capsule; Reference = Oral solution.|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||94.54|79.11|
71138330|NCT06172348|141776480|OTHER||Ratio of Adjusted Geometric Means|76.99|||||TWO_SIDED|90.0|70.65|83.9|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR2 capsule; Reference = Oral solution.|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||83.90|70.65|
71138331|NCT06172348|141776481|OTHER||Ratio of Adjusted Geometric Means|123.92|||||TWO_SIDED|90.0|105.16|146.02|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR1 capsule (fed); Reference = MR1 capsule (fasted).|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||146.02|105.16|
71138332|NCT06172348|141776481|OTHER||Ratio of Adjusted Geometric Means|129.79|||||TWO_SIDED|90.0|111.51|151.06|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR2 capsule (fed); Reference = MR2 capsule (fasted).|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||151.06|111.51|
71138333|NCT06172348|141776482|OTHER||Ratio of Adjusted Geometric Means|107.48|||||TWO_SIDED|90.0|96.46|119.76|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR1 capsule (fed); Reference = MR1 capsule (fasted).|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||119.76|96.46|
71138334|NCT06172348|141776482|OTHER||Ratio of Adjusted Geometric Means|109.63|||||TWO_SIDED|90.0|99.19|121.17|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR2 capsule (fed); Reference = MR2 capsule (fasted).|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||121.17|99.19|
71138335|NCT02831764|141776500|NON_INFERIORITY|Treatment with DTG+ 3TC was to be declared non-inferior to treatment with DTG+TDF/FTC if the lower end of a two-sided 95% confidence interval for the difference between the two groups in response rates at Week 48 was greater than -10%.|Adjusted difference in proportion|-0.7|||||TWO_SIDED|95.0|-4.3|2.9|||||Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<= vs. \>100,000 copies per milliliter) and CD4+ cell count (\<= vs. \>200 cells per cubic millimeter \[cells/mm\^3\]).|||2.9|-4.3|
71138336|NCT02831764|141776501|NON_INFERIORITY|Treatment with DTG+ 3TC was to be declared non-inferior to treatment with DTG+TDF/FTC if the lower end of a two-sided 95% confidence interval for the difference between the two groups in response rates at Week 24 was greater than -10%.|Adjusted difference in proportion|0.1|||||TWO_SIDED|95.0|-3.4|3.6|||||Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<= vs. \>100,000 c/mL) and CD4+ cell count (\<= vs. \>200 cells/mm\^3).|||3.6|-3.4|
71138337|NCT02831764|141776502|OTHER||Adjusted difference in proportion|-1.8|||||TWO_SIDED|95.0|-6.4|2.7|||||Week 96. Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<= vs. \>100,000 c/mL) and CD4+ cell count (\<= vs. \>200 cells/mm\^3).|||2.7|-6.4|
71138338|NCT02831764|141776503|OTHER||Adjusted difference in proportion|0.0|||||TWO_SIDED|95.0|-5.3|5.3|||||Week 144. Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<= vs. \>100,000 c/mL) and CD4+ cell count (\<= vs. \>200 cells/mm\^3).|||5.3|-5.3|
71138339|NCT02831764|141776504|OTHER||Hazard Ratio (HR)|1.02||||0.797|TWO_SIDED|95.0|0.88|1.19||The generalised Wilcoxon procedure was used to estimate a p-value for detecting a difference in cumulative incidence curves between treatment groups.|Generalised Wilcoxon procedure||Hazard ratios were estimated using the Cox proportional hazard regression model.|||1.19|0.88|0.797
71138340|NCT02831764|141776508|OTHER||Mean Difference (Net)|25.6||||0.043|TWO_SIDED|95.0|0.8|50.4|||Mixed Model Repeated Measures (MMRM)||Week 24. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||50.4|0.8|0.043
71138341|NCT02831764|141776508|OTHER||Mean Difference (Net)|8.5||||0.523|TWO_SIDED|95.0|-17.7|34.8|||MMRM||Week 48. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||34.8|-17.7|0.523
71138342|NCT02831764|141776509|OTHER||Mean Difference (Net)|7.4||||0.635|TWO_SIDED|95.0|-23.2|38.0|||Mixed Model Repeated Measures (MMRM)||Week 96. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||38.0|-23.2|0.635
71138343|NCT02831764|141776510|OTHER||Mean Difference (Net)|5.1||||0.777|TWO_SIDED|95.0|-29.9|40.0|||MMRM||Week 144.Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||40.0|-29.9|0.777
71138344|NCT02831764|141776521|OTHER||Mean Difference (Net)|-0.03|||<|0.001|TWO_SIDED|95.0|-0.05|-0.02|||MMRM||Week 24. Serum Cystatin C.|||-0.02|-0.05|<0.001
71138345|NCT02831764|141776521|OTHER||Mean Difference (Net)|-0.02||||0.022|TWO_SIDED|95.0|-0.03|0.0|||MMRM||Week 48. Serum Cystatin C.|||0.00|-0.03|0.022
71138346|NCT02831764|141776521|OTHER||Mean Difference (Net)|-0.2||||0.797|TWO_SIDED|95.0|-1.4|1.1|||MMRM||Week 24. Serum RBP|||1.1|-1.4|0.797
71138347|NCT02831764|141776521|OTHER||Mean Difference (Net)|0.7||||0.258|TWO_SIDED|95.0|-0.5|1.9|||MMRM||Week 48. Serum RBP|||1.9|-0.5|0.258
71138348|NCT02831764|141776522|OTHER||Mean Difference (Net)|-0.02||||0.034|TWO_SIDED|95.0|-0.03|0.0|||MMRM||Week 96. Serum Cystatin C.|||0.00|-0.03|0.034
71138349|NCT02831764|141776523|OTHER||Mean Difference (Net)|-0.02||||0.006|TWO_SIDED|95.0|-0.04|-0.01|||MMRM||Week 144. Serum Cystatin C.|||-0.01|-0.04|0.006
71138350|NCT02831764|141776526|OTHER||Mean Difference (Net)|3.6|||<|0.001|TWO_SIDED|95.0|1.8|5.4|||MMRM||Week 24. GFR Cystatin C adjusted.|||5.4|1.8|<0.001
71138351|NCT02831764|141776526|OTHER||Mean Difference (Net)|1.7||||0.056|TWO_SIDED|95.0|0.0|3.5|||MMRM||Week 48. GFR Cystatin C adjusted.|||3.5|0.0|0.056
71138352|NCT02831764|141776526|OTHER||Mean Difference (Net)|3.4|||<|0.001|TWO_SIDED|95.0|1.7|5.2|||MMRM||Week 24. GFR creatinine adjusted.|||5.2|1.7|<0.001
71138353|NCT02831764|141776526|OTHER||Mean Difference (Net)|3.3|||<|0.001|TWO_SIDED|95.0|1.6|5.0|||MMRM||Week 48. GFR creatinine adjusted.|||5.0|1.6|<0.001
71138354|NCT02831764|141776529|OTHER||Mean Difference (Net)|-3.02|||<|0.001|TWO_SIDED|95.0|-4.49|-1.55|||MMRM||Week 24. Serum or Plasma Creatinine|||-1.55|-4.49|<0.001
71138355|NCT02831764|141776529|OTHER||Mean Difference (Net)|-3.12|||<|0.001|TWO_SIDED|95.0|-4.59|-1.65|||MMRM||Week 48. Serum or Plasma creatinine|||-1.65|-4.59|<0.001
71138356|NCT02831764|141776530|OTHER||Mean Difference (Net)|-3.04|||<|0.001|TWO_SIDED|95.0|-4.56|-1.53|||MMRM||Week 96. Serum or Plasma creatinine|||-1.53|-4.56|<0.001
71138357|NCT02831764|141776531|OTHER||Mean Difference (Net)|-2.86|||<|0.001|TWO_SIDED|95.0|-4.52|-1.19|||MMRM||Week 144. Serum or Plasma creatinine|||-1.19|-4.52|<0.001
71138358|NCT02831764|141776532|OTHER||Ratio of geometric means|0.917|||<|0.001|TWO_SIDED|95.0|0.893|0.941|||MMRM||Week 24. Serum B2M.|||0.941|0.893|<0.001
71138359|NCT02831764|141776532|OTHER||Ratio of geometric means|0.914|||<|0.001|TWO_SIDED|95.0|0.89|0.939|||MMRM||Week 48. Serum B2M.|||0.939|0.890|<0.001
71138360|NCT02831764|141776532|OTHER||Ratio of geometric means|0.748||||0.002|TWO_SIDED|95.0|0.621|0.901|||MMRM||Week 24. Urine B2M.|||0.901|0.621|0.002
71138361|NCT02831764|141776532|OTHER||Ratio of geometric means|0.693||||0.005|TWO_SIDED|95.0|0.538|0.892|||MMRM||Week 48. Urine B2M.|||0.892|0.538|0.005
71138362|NCT02831764|141776532|OTHER||Ratio of geometric means|0.889||||0.036|TWO_SIDED|95.0|0.796|0.992|||MMRM||Week 24. Urine Albumin/Creatinine.|||0.992|0.796|0.036
70864306|NCT00676338|141214156|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|1.04|STANDARD_ERROR_OF_MEAN|0.05||0.398|TWO_SIDED|95.0|0.95|1.14||No multiple adjustment were done.|ANCOVA|||Fasting triglycerides data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using ANCOVA model with treatment and country as factors and baseline triglycerides as a covariate.||1.14|0.95|0.398
71138363|NCT02831764|141776532|OTHER||Ratio of geometric means|0.938||||0.308|TWO_SIDED|95.0|0.83|1.061|||MMRM||Week 48. Urine Albumin/Creatinine.|||1.061|0.830|0.308
71138364|NCT02831764|141776532|OTHER||Ratio of geometric means|0.781||||0.007|TWO_SIDED|95.0|0.654|0.934|||MMRM||Week 24. Urine B2M/Urine Creatinine.|||0.934|0.654|0.007
71138365|NCT02831764|141776532|OTHER||Ratio of geometric means|0.742||||0.012|TWO_SIDED|95.0|0.588|0.935|||MMRM||Week 48. Urine B2M/Urine Creatinine.|||0.935|0.588|0.012
71138366|NCT02831764|141776532|OTHER||Ratio of geometric means|0.979||||0.728|TWO_SIDED|95.0|0.868|1.104|||MMRM||Week 24. Urine Phosphate.|||1.104|0.868|0.728
71138367|NCT02831764|141776532|OTHER||Ratio of geometric means|1.062||||0.311|TWO_SIDED|95.0|0.945|1.194|||MMRM||Week 48. Urine Phosphate.|||1.194|0.945|0.311
71138368|NCT02831764|141776532|OTHER||Ratio of geometric means|0.826|||<|0.001|TWO_SIDED|95.0|0.769|0.887|||MMRM||Week 24. Urine Protein/Creatinine.|||0.887|0.769|<0.001
71138369|NCT02831764|141776532|OTHER||Ratio of geometric means|0.86|||<|0.001|TWO_SIDED|95.0|0.795|0.93|||MMRM||Week 48. Urine Protein/Creatinine.|||0.930|0.795|<0.001
71138370|NCT02831764|141776532|OTHER||Ratio of geometric means|0.796||||0.003|TWO_SIDED|95.0|0.683|0.927|||MMRM||Week 24. Urine RBP 4|||0.927|0.683|0.003
71138371|NCT02831764|141776532|OTHER||Ratio of geometric means|0.903||||0.2|TWO_SIDED|95.0|0.773|1.056|||MMRM||Week 48. Urine RBP 4|||1.056|0.773|0.200
71138372|NCT02831764|141776532|OTHER||Ratio of geometric means|0.826||||0.003|TWO_SIDED|95.0|0.728|0.936|||MMRM||Week 24. Urine RBP 4/Urine Creatinine|||0.936|0.728|0.003
71138373|NCT02831764|141776532|OTHER||Ratio of geometric means|0.888||||0.052|TWO_SIDED|95.0|0.787|1.001|||MMRM||Week 48. Urine RBP 4/Urine Creatinine|||1.001|0.787|0.052
71138374|NCT02831764|141776533|OTHER||Ratio of geometric means|0.942||||0.338|TWO_SIDED|95.0|0.833|1.065|||MMRM||Week 96. Urine Albumin/Creatinine.|||1.065|0.833|0.338
71138375|NCT02831764|141776533|OTHER||Ratio of geometric means|0.671|||<|0.001|TWO_SIDED|95.0|0.545|0.826|||MMRM||Week 96. Urine B2M/Urine Creatinine.|||0.826|0.545|<0.001
71138376|NCT02831764|141776533|OTHER||Ratio of geometric means|1.082||||0.174|TWO_SIDED|95.0|0.966|1.213|||MMRM||Week 96. Urine Phosphate.|||1.213|0.966|0.174
71138377|NCT02831764|141776533|OTHER||Ratio of geometric means|0.873|||<|0.001|TWO_SIDED|95.0|0.806|0.946|||MMRM||Week 96. Urine Protein/Creatinine.|||0.946|0.806|<0.001
71138378|NCT02831764|141776533|OTHER||Ratio of geometric means|0.8|||<|0.001|TWO_SIDED|95.0|0.716|0.894|||MMRM||Week 96. Urine RBP 4/Urine Creatinine|||0.894|0.716|<0.001
71138379|NCT02831764|141776534|OTHER||Ratio of geometric means|0.971||||0.658|TWO_SIDED|95.0|0.852|1.107|||MMRM||Week 144. Urine Albumin/Creatinine.|||1.107|0.852|0.658
71138380|NCT02831764|141776534|OTHER||Ratio of geometric means|0.584|||<|0.001|TWO_SIDED|95.0|0.483|0.706|||MMRM||Week 144. Urine B2M/Urine Creatinine.|||0.706|0.483|<0.001
71138381|NCT02831764|141776534|OTHER||Ratio of geometric means|1.0||||0.993|TWO_SIDED|95.0|0.892|1.12|||MMRM||Week 144. Urine Phosphate.|||1.120|0.892|0.993
71138382|NCT02831764|141776534|OTHER||Ratio of geometric means|0.847|||<|0.001|TWO_SIDED|95.0|0.785|0.913|||MMRM||Week 144. Urine Protein/Creatinine.|||0.913|0.785|<0.001
71138383|NCT02831764|141776534|OTHER||Ratio of geometric means|0.739|||<|0.001|TWO_SIDED|95.0|0.667|0.819|||MMRM||Week 144. Urine RBP 4/Urine Creatinine|||0.819|0.667|<0.001
71138384|NCT02831764|141776535|OTHER||Mean Difference (Net)|-2.66|||<|0.001|TWO_SIDED|95.0|-3.25|-2.08|||MMRM||Week 24, Bone ALP|||-2.08|-3.25|<0.001
71138385|NCT02831764|141776535|OTHER||Mean Difference (Net)|-3.09|||<|0.001|TWO_SIDED|95.0|-3.75|-2.44|||MMRM||Week 48, Bone ALP|||-2.44|-3.75|<0.001
71138386|NCT02831764|141776535|OTHER||Mean Difference (Net)|-4.67|||<|0.001|TWO_SIDED|95.0|-5.63|-3.71|||MMRM||Week 28, Serum Osteocalcin|||-3.71|-5.63|<0.001
71138387|NCT02831764|141776535|OTHER||Mean Difference (Net)|-5.9|||<|0.001|TWO_SIDED|95.0|-6.89|-4.91|||MMRM||Week 48, Serum Osteocalcin|||-4.91|-6.89|<0.001
71138388|NCT02831764|141776535|OTHER||Mean Difference (Net)|-13.5|||<|0.001|TWO_SIDED|95.0|-16.4|-10.6|||MMRM||Week 24, Serum PINP|||-10.6|-16.4|<0.001
71138389|NCT02831764|141776535|OTHER||Mean Difference (Net)|-12.8|||<|0.001|TWO_SIDED|95.0|-15.4|-10.2|||MMRM||Week 48, Serum PINP|||-10.2|-15.4|<0.001
71138390|NCT02831764|141776535|OTHER||Mean Difference (Net)|-0.127|||<|0.001|TWO_SIDED|95.0|-0.164|-0.09|||MMRM||Week 24, CTX-1|||-0.0900|-0.1640|<0.001
71138391|NCT02831764|141776535|OTHER||Mean Difference (Net)|-0.2043|||<|0.001|TWO_SIDED|95.0|-0.2532|-0.1554|||MMRM||Week 48, CTX-1|||-0.1554|-0.2532|<0.001
71138392|NCT02831764|141776536|OTHER||Mean Difference (Net)|-2.13|||<|0.001|TWO_SIDED|95.0|-2.72|-1.54|||MMRM||Week 96, Bone ALP|||-1.54|-2.72|<0.001
71138393|NCT02831764|141776536|OTHER||Mean Difference (Net)|-3.77|||<|0.001|TWO_SIDED|95.0|-4.69|-2.85|||MMRM||Week 96, Serum Osteocalcin|||-2.85|-4.69|<0.001
71138394|NCT02831764|141776536|OTHER||Mean Difference (Net)|-12.6|||<|0.001|TWO_SIDED|95.0|-16.8|-8.3|||MMRM||Week 96, Serum PINP|||-8.3|-16.8|<0.001
71138395|NCT02831764|141776536|OTHER||Mean Difference (Net)|-0.1183|||<|0.001|TWO_SIDED|95.0|-0.1529|-0.0838|||MMRM||Week 96, CTX-1|||-0.0838|-0.1529|<0.001
71138396|NCT02831764|141776537|OTHER||Mean Difference (Net)|-2.13|||<|0.001|TWO_SIDED|95.0|-2.74|-1.53|||MMRM||Week 144, Bone ALP|||-1.53|-2.74|<0.001
71138397|NCT02831764|141776537|OTHER||Mean Difference (Net)|-3.89|||<|0.001|TWO_SIDED|95.0|-4.87|-2.91|||MMRM||Week 144, Serum Osteocalcin|||-2.91|-4.87|<0.001
71138398|NCT02831764|141776537|OTHER||Mean Difference (Net)|-9.5|||<|0.001|TWO_SIDED|95.0|-12.8|-6.2|||MMRM||Week 144, Serum PINP|||-6.2|-12.8|<0.001
71138399|NCT02831764|141776537|OTHER||Mean Difference (Net)|-0.1364|||<|0.001|TWO_SIDED|95.0|-0.1739|-0.0988|||MMRM||Week 144, CTX-1|||-0.0988|-0.1739|<0.001
71138400|NCT02831764|141776538|OTHER||Mean Difference (Net)|-4.2||||0.015|TWO_SIDED|95.0|-7.5|-0.8|||MMRM||Week 24|||-0.8|-7.5|0.015
71138401|NCT02831764|141776538|OTHER||Mean Difference (Net)|-0.1||||0.96|TWO_SIDED|95.0|-2.8|2.6|||MMRM||Week 48|||2.6|-2.8|0.960
71138402|NCT02831764|141776539|OTHER||Mean Difference (Net)|-3.0||||0.048|TWO_SIDED|95.0|-5.9|0.0|||MMRM||Week 96, Serum Vitamin D|||0.0|-5.9|0.048
71138403|NCT02831764|141776540|OTHER||Mean Difference (Net)|-0.2||||0.887|TWO_SIDED|95.0|-3.6|3.1|||MMRM||Week 144, Serum Vitamin D|||3.1|-3.6|0.887
71138404|NCT02831764|141776547|OTHER||Mean Difference (Final Values)|3.5|||<|0.001|TWO_SIDED|95.0|1.5|5.6|||Fisher Exact||Week 24|||5.6|1.5|<0.001
71138405|NCT02831764|141776547|OTHER||Mean Difference (Final Values)|2.8||||0.037|TWO_SIDED|95.0|0.2|5.4|||Fisher Exact||Week 48|||5.4|0.2|0.037
71138406|NCT02831764|141776548|OTHER||Mean Difference (Final Values)|3.1||||0.045|TWO_SIDED|95.0|0.2|6.1|||Fisher Exact||Week 96|||6.1|0.2|0.045
71138407|NCT02831764|141776549|OTHER||Mean Difference (Final Values)|2.6||||0.16|TWO_SIDED|95.0|-0.8|6.0|||Fisher Exact||Week 144|||6.0|-0.8|0.160
71138408|NCT02831764|141776554|OTHER||Mean Difference (Net)|37.8|||||TWO_SIDED|95.0|9.98|65.62|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and relevant Baseline plasma HIV-1 RNA interaction.|||65.62|9.98|
71138409|NCT02831764|141776554|OTHER||Mean Difference (Net)|-26.81|||||TWO_SIDED|95.0|-82.72|29.1|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and Baseline plasma HIV-1 RNA interaction.|||29.10|-82.72|
71138410|NCT02831764|141776554|OTHER||Mean Difference (Net)|61.72|||||TWO_SIDED|95.0|-26.94|150.39|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||150.39|-26.94|
71138411|NCT02831764|141776554|OTHER||Mean Difference (Net)|22.57|||||TWO_SIDED|95.0|-3.42|48.55|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||48.55|-3.42|
71138412|NCT02831764|141776554|OTHER||Mean Difference (Net)|38.99|||||TWO_SIDED|95.0|5.88|72.09|||||Age Group,\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||72.09|5.88|
71138413|NCT02831764|141776554|OTHER||Mean Difference (Net)|-9.9|||||TWO_SIDED|95.0|-53.1|33.3|||||Age Group,35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||33.30|-53.10|
71138414|NCT02831764|141776554|OTHER||Mean Difference (Net)|65.53|||||TWO_SIDED|95.0|-14.43|145.5|||||Age Group,\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||145.50|-14.43|
71138415|NCT02831764|141776554|OTHER||Mean Difference (Net)|59.66|||||TWO_SIDED|95.0|-8.62|127.94|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||127.94|-8.62|
71138416|NCT02831764|141776554|OTHER||Mean Difference (Net)|19.23|||||TWO_SIDED|95.0|-7.65|46.1|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||46.10|-7.65|
71138417|NCT02831764|141776554|OTHER||Mean Difference (Net)|19.04|||||TWO_SIDED|95.0|-11.06|49.13|||||Race group-white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||49.13|-11.06|
71138418|NCT02831764|141776554|OTHER||Mean Difference (Net)|43.25|||||TWO_SIDED|95.0|-30.59|117.09|||||Race group-African Am/African H. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||117.09|-30.59|
71138419|NCT02831764|141776554|OTHER||Mean Difference (Net)|12.8|||||TWO_SIDED|95.0|-72.14|97.73|||||Race group-Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||97.73|-72.14|
71138420|NCT02831764|141776554|OTHER||Mean Difference (Net)|62.01|||||TWO_SIDED|95.0|-16.09|140.12|||||Race group-Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||140.12|-16.09|
71138421|NCT02831764|141776555|OTHER||Mean Difference (Net)|6.9|||||TWO_SIDED|95.0|-22.7|36.6|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and relevant Baseline plasma HIV-1 RNA interaction.|||36.6|-22.7|
71138422|NCT02831764|141776555|OTHER||Mean Difference (Net)|13.2|||||TWO_SIDED|95.0|-46.8|73.2|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and Baseline plasma HIV-1 RNA interaction.|||73.2|-46.8|
71138423|NCT02831764|141776555|OTHER||Mean Difference (Net)|57.7|||||TWO_SIDED|95.0|-37.2|152.5|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||152.5|-37.2|
71138424|NCT02831764|141776555|OTHER||Mean Difference (Net)|4.1|||||TWO_SIDED|95.0|-23.5|31.7|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||31.7|-23.5|
71138425|NCT02831764|141776555|OTHER||Mean Difference (Net)|32.5|||||TWO_SIDED|95.0|-2.7|67.7|||||Age Group-1,\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||67.7|-2.7|
71138426|NCT02831764|141776555|OTHER||Mean Difference (Net)|-31.5|||||TWO_SIDED|95.0|-77.1|14.2|||||Age Group-1,35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||14.2|-77.1|
71138427|NCT02831764|141776555|OTHER||Mean Difference (Net)|5.2|||||TWO_SIDED|95.0|-81.4|91.8|||||Age Group-1,\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||91.8|-81.4|
71138428|NCT02831764|141776555|OTHER||Mean Difference (Net)|8.6|||||TWO_SIDED|95.0|-19.4|36.5|||||Age Group-2, \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||36.5|-19.4|
71138429|NCT02831764|141776555|OTHER||Mean Difference (Net)|4.5|||||TWO_SIDED|95.0|-82.3|91.3|||||Age Group-2, \>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||91.3|-82.3|
70864307|NCT00676338|141214159|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|1.09||0.201|TWO_SIDED|95.0|-3.52|0.74||No multiple adjustment were done.|Mixed Models Analysis|||Change in Systolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline systolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||0.74|-3.52|0.201
70864308|NCT00676338|141214159|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|1.24||0.693|TWO_SIDED|95.0|-1.94|2.93||No multiple adjustment were done.|Mixed Models Analysis|||Change in Systolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline systolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||2.93|-1.94|0.693
70864309|NCT00676338|141214159|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.56|STANDARD_ERROR_OF_MEAN|1.22||0.646|TWO_SIDED|95.0|-1.84|2.96||No multiple adjustment were done.|Mixed Models Analysis|||Change in Systolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline systolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||2.96|-1.84|0.646
70864310|NCT00676338|141214160|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.7||0.61|TWO_SIDED|95.0|-1.02|1.73||No multiple adjustment were done.|Mixed Models Analysis|||Change in Diastolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline diastolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||1.73|-1.02|0.610
70864311|NCT00676338|141214160|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|0.8||0.013|TWO_SIDED|95.0|0.43|3.58||No multiple adjustment were done.|Mixed Models Analysis|||Change in Diastolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline diastolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||3.58|0.43|0.013
70864312|NCT00676338|141214160|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.79||0.946|TWO_SIDED|95.0|-1.6|1.49||No multiple adjustment were done.|Mixed Models Analysis|||Change in Diastolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline diastolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||1.49|-1.60|0.946
70864313|NCT02124161|141214168|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.74|1.12||||||Serotype 1: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.12|0.74|
70864314|NCT02124161|141214168|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.7|0.98||||||Serotype 3: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||0.98|0.70|
70864315|NCT02124161|141214168|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.55|0.91||||||Serotype 4: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||0.91|0.55|
70864316|NCT02124161|141214168|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.78|1.18||||||Serotype 5: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.18|0.78|
70864317|NCT02124161|141214168|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.53|0.85||||||Serotype 6A: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||0.85|0.53|
71138430|NCT02831764|141776555|OTHER||Mean Difference (Net)|-27.3|||||TWO_SIDED|95.0|-100.8|46.1|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||46.1|-100.8|
71138431|NCT02831764|141776555|OTHER||Mean Difference (Net)|12.8|||||TWO_SIDED|95.0|-15.7|41.2|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||41.2|-15.7|
71138432|NCT02831764|141776555|OTHER||Mean Difference (Net)|11.3|||||TWO_SIDED|95.0|-20.4|43.1|||||Race group-white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||43.1|-20.4|
70864318|NCT02124161|141214168|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.64|1.08||||||Serotype 6B: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.08|0.64|
71138433|NCT02831764|141776555|OTHER||Mean Difference (Net)|-37.8|||||TWO_SIDED|95.0|-119.6|44.0|||||Race group-African Am/African H. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||44.0|-119.6|
71138434|NCT02831764|141776555|OTHER||Mean Difference (Net)|15.6|||||TWO_SIDED|95.0|-74.4|105.7|||||Race group-Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||105.7|-74.4|
71138435|NCT02831764|141776555|OTHER||Mean Difference (Net)|37.6|||||TWO_SIDED|95.0|-45.4|120.5|||||Race group-Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||120.5|-45.4|
70864319|NCT02124161|141214168|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.83|1.14||||||Serotype 7F: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.14|0.83|
71138436|NCT02831764|141776556|OTHER||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|-34.1|35.0|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and relevant Baseline plasma HIV-1 RNA interaction.|||35.0|-34.1|
71138437|NCT02831764|141776556|OTHER||Mean Difference (Net)|14.7|||||TWO_SIDED|95.0|-55.6|84.9|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and Baseline plasma HIV-1 RNA interaction.|||84.9|-55.6|
71138438|NCT02831764|141776556|OTHER||Mean Difference (Net)|26.5|||||TWO_SIDED|95.0|-87.3|140.3|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||140.3|-87.3|
71138439|NCT02831764|141776556|OTHER||Mean Difference (Net)|2.8|||||TWO_SIDED|95.0|-29.4|35.1|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||35.1|-29.4|
71138440|NCT02831764|141776556|OTHER||Mean Difference (Net)|8.3|||||TWO_SIDED|95.0|-32.5|49.1|||||Age Group,\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||49.1|-32.5|
71138441|NCT02831764|141776556|OTHER||Mean Difference (Net)|-13.3|||||TWO_SIDED|95.0|-67.6|41.1|||||Age Group,35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||41.1|-67.6|
71138442|NCT02831764|141776556|OTHER||Mean Difference (Net)|32.7|||||TWO_SIDED|95.0|-68.5|133.9|||||Age Group,\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||133.9|-68.5|
71138443|NCT02831764|141776556|OTHER||Mean Difference (Net)|5.1|||||TWO_SIDED|95.0|-80.7|90.8|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||90.8|-80.7|
71138444|NCT02831764|141776556|OTHER||Mean Difference (Net)|2.1|||||TWO_SIDED|95.0|-31.1|35.3|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||35.3|-31.1|
71138445|NCT02831764|141776556|OTHER||Mean Difference (Net)|13.7|||||TWO_SIDED|95.0|-23.2|50.6|||||Race group-white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||50.6|-23.2|
71138446|NCT02831764|141776556|OTHER||Mean Difference (Net)|-57.4|||||TWO_SIDED|95.0|-155.3|40.4|||||Race group-African Am/African H. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||40.4|-155.3|
71138447|NCT02831764|141776556|OTHER||Mean Difference (Net)|-40.1|||||TWO_SIDED|95.0|-144.2|64.0|||||Race group-Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||64.0|-144.2|
71138448|NCT02831764|141776556|OTHER||Mean Difference (Net)|33.1|||||TWO_SIDED|95.0|-63.3|129.6|||||Race group-Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||129.6|-63.3|
71138449|NCT02831764|141776557|OTHER||Mean Difference (Net)|9.1|||||TWO_SIDED|95.0|-31.1|49.2|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and relevant Baseline plasma HIV-1 RNA interaction.|||49.2|-31.1|
71138450|NCT02831764|141776557|OTHER||Mean Difference (Net)|-16.6|||||TWO_SIDED|95.0|-98.9|65.8|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and Baseline plasma HIV-1 RNA interaction.|||65.8|-98.9|
71138451|NCT02831764|141776557|OTHER||Mean Difference (Net)|56.0|||||TWO_SIDED|95.0|-77.2|189.1|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||189.1|-77.2|
71138452|NCT02831764|141776557|OTHER||Mean Difference (Net)|2.4|||||TWO_SIDED|95.0|-35.2|39.9|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||39.9|-35.2|
71138453|NCT02831764|141776557|OTHER||Mean Difference (Net)|25.8|||||TWO_SIDED|95.0|-22.3|74.0|||||Age Group,\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||74.0|-22.3|
71138454|NCT02831764|141776557|OTHER||Mean Difference (Net)|-36.4|||||TWO_SIDED|95.0|-98.6|25.8|||||Age Group,35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||25.8|-98.6|
71138455|NCT02831764|141776557|OTHER||Mean Difference (Net)|24.1|||||TWO_SIDED|95.0|-89.0|137.2|||||Age Group,\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||137.2|-89.0|
71138456|NCT02831764|141776557|OTHER||Mean Difference (Net)|-26.9|||||TWO_SIDED|95.0|-125.9|72.2|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||72.2|-125.9|
71138457|NCT02831764|141776557|OTHER||Mean Difference (Net)|8.1|||||TWO_SIDED|95.0|-30.3|46.5|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||46.5|-30.3|
71138458|NCT02831764|141776557|OTHER||Mean Difference (Net)|3.5|||||TWO_SIDED|95.0|-39.4|46.3|||||Race group-white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||46.3|-39.4|
71138459|NCT02831764|141776557|OTHER||Mean Difference (Net)|-121.2|||||TWO_SIDED|95.0|-237.2|-5.1|||||Race group-African Am/African H. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||-5.1|-237.2|
71138460|NCT02831764|141776557|OTHER||Mean Difference (Net)|13.1|||||TWO_SIDED|95.0|-106.4|132.6|||||Race group-Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||132.6|-106.4|
71138461|NCT02831764|141776557|OTHER||Mean Difference (Net)|114.3|||||TWO_SIDED|95.0|4.6|224.0|||||Race group-Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||224.0|4.6|
71138462|NCT02831764|141776558|OTHER||Mean Difference (Net)|-0.0019||||0.759|TWO_SIDED|95.0|-0.0137|0.01|||MMRM||Week 4. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA , Baseline CD4+ cell count , and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0100|-0.0137|0.759
71138463|NCT02831764|141776558|OTHER||Mean Difference (Net)|0.0003||||0.943|TWO_SIDED|95.0|-0.0088|0.0095|||MMRM||Week 24. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA , Baseline CD4+ cell count , and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0095|-0.0088|0.943
71138464|NCT02831764|141776558|OTHER||Mean Difference (Net)|-0.0019||||0.703|TWO_SIDED|95.0|-0.0117|0.0079|||MMRM||Week 48. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA , Baseline CD4+ cell count , and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0079|-0.0117|0.703
71138465|NCT02831764|141776559|OTHER||Mean Difference (Net)|-0.0003||||0.957|TWO_SIDED|95.0|-0.011|0.0104|||MMRM||Week 96. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0104|-0.0110|0.957
71138466|NCT02831764|141776560|OTHER||Mean Difference (Net)|0.0079||||0.162|TWO_SIDED|95.0|-0.0032|0.0189|||MMRM||Week 144. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0189|-0.0032|0.162
71138467|NCT02831764|141776561|OTHER||Mean Difference (Net)|-1.3||||0.045|TWO_SIDED|95.0|-2.6|0.0|||MMRM||Week 4. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0|-2.6|0.045
71138468|NCT02831764|141776561|OTHER||Mean Difference (Net)|-0.6||||0.358|TWO_SIDED|95.0|-1.9|0.7|||MMRM||Week 24. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.7|-1.9|0.358
71138469|NCT02831764|141776561|OTHER||Mean Difference (Net)|-0.6||||0.328|TWO_SIDED|95.0|-1.9|0.6|||MMRM||Week 48. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.6|-1.9|0.328
71138470|NCT02831764|141776562|OTHER||Mean Difference (Net)|-0.7||||0.318|TWO_SIDED|95.0|-2.1|0.7|||MMRM||Week 96. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.7|-2.1|0.318
71138471|NCT02831764|141776563|OTHER||Mean Difference (Net)|0.3||||0.674|TWO_SIDED|95.0|-1.0|1.6|||MMRM||Week 144. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||1.6|-1.0|0.674
71138472|NCT04564846|141776564|OTHER||Risk Ratio (RR)|0.974||||0.1628|TWO_SIDED|95.0|0.938|1.011|||Analysis of Covariance||Estimated Difference from Placebo Across All Time Points. Log transformed values analyzed using an Analysis of Covariance model with treatment and time point as effects and baseline HbA1c as a covariate.|Comparison to Placebo Across All Time Points||1.011|0.938|0.1628
71138473|NCT04564846|141776566|OTHER||Risk Ratio (RR)|0.784||||0.0674|TWO_SIDED|95.0|0.605|1.017|||Analysis of Covariance|||Estimated Difference from Placebo Across All Time Points|Log transformed values analyzed using an Analysis of Covariance model with treatment and time point as effects and baseline HbA1c as a covariate.|1.017|0.605|0.0674
71138474|NCT04564846|141776567|OTHER|Log transformed values analyzed using an Analysis of Covariance model with treatment and time point as effects and baseline HbA1c as a covariate.|Risk Ratio, log|1.067||||0.8182|TWO_SIDED|95.0|0.976|1.167|||Analysis of Covariance|||Estimated Difference from Placebo Across All Time Points.||1.167|0.976|0.8182
71138475|NCT04564846|141776568|OTHER|AUC Parameters analyzed using an Analysis of Covariance model with treatment as the main effect and baseline HbA1c as a covariate.|Risk Ratio, log|1.007||||0.8182|TWO_SIDED|95.0|0.951|1.066|||Analysis of Covariance|||||1.066|0.951|0.8182
71138476|NCT04564846|141776569|OTHER||Analysis of Variance|0.4628|||||TWO_SIDED|||||Parameter analyzed using an Analysis of Variance model with treatment as the main effect.||||||||
70864320|NCT02124161|141214168|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.69|1.0||||||Serotype 9V: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.0|0.69|
71138477|NCT03016312|141776583|SUPERIORITY||Hazard Ratio (HR)|1.184||||0.094|TWO_SIDED|95.0|0.971|1.445|||Log Rank|||Unstratified Analysis||1.445|0.971|0.0940
71138478|NCT03016312|141776583|SUPERIORITY||Hazard Ratio (HR)|1.118||||0.2786|TWO_SIDED|95.0|0.913|1.37|||Log Rank|||Stratified Analysis||1.370|0.913|0.2786
71138479|NCT03016312|141776584|SUPERIORITY||Difference in Event Free Rate|-0.2||||0.9391|TWO_SIDED|95.0|-5.38|4.97|||z-test|||Difference in Event Free Rate - 6 months||4.97|-5.38|0.9391
71138480|NCT03016312|141776584|SUPERIORITY||Difference in Event Free Rate|-4.03||||0.2706|TWO_SIDED|95.0|-11.21|3.14|||z-test|||Difference in Event Free Rate - 12 months||3.14|-11.21|0.2706
71138481|NCT03016312|141776586|SUPERIORITY||Hazard Ratio (HR)|0.917||||0.3157|TWO_SIDED|95.0|0.775|1.086|||Log Rank|||Unstratified Analysis||1.086|0.775|0.3157
71138482|NCT03016312|141776586|SUPERIORITY||Hazard Ratio (HR)|0.899||||0.2366|TWO_SIDED|95.0|0.754|1.072|||Log Rank|||Stratified Analysis||1.072|0.754|0.2366
71138483|NCT03016312|141776587|SUPERIORITY||Difference in Event Free Rate|2.21||||0.5959|TWO_SIDED|95.0|-5.95|10.37|||z-test|||Difference in Event Free Rate - 6 months||10.37|-5.95|0.5959
71138484|NCT03016312|141776587|SUPERIORITY||Difference in Event Free Rate|1.44||||0.6262|TWO_SIDED|95.0|-4.35|7.23|||z-test|||Difference in Event Free Rate - 12 months||7.23|-4.35|0.6262
71138485|NCT03016312|141776588|SUPERIORITY||Difference in 50% Decrease Response Rate|1.6|||||TWO_SIDED|2.0|-4.5|7.8|||||||Odds Ratio: 1.1 95%CI: 0.8, 1.5|7.8|-4.5|
70872184|NCT02495168|141229589|SUPERIORITY||LS Mean Difference|2.606|||<|0.0001|TWO_SIDED|95.0|1.939|3.273||Threshold for significance at 0.05 level.|ANCOVA|||LS means difference and p-value from ANCOVA model with treatment and site as fixed effects, baseline FEV1 as covariate and endpoint as outcome on Symbicort and Placebo participants only.||3.273|1.939|<0.0001
71138486|NCT03016312|141776589|SUPERIORITY||Hazard Ratio (HR)|1.055||||0.5359|TWO_SIDED|95.0|0.89|1.251|||Log Rank|||Unstratified Analysis||1.251|0.890|0.5359
71138487|NCT03016312|141776589|SUPERIORITY||Hazard Ratio (HR)|1.037||||0.6857|TWO_SIDED|95.0|0.869|1.238|||Log Rank|||Stratified Analysis||1.238|0.869|0.6857
71138488|NCT00496015|141776602|SUPERIORITY|Superiority criteria: The lower limit (LL) of the standardized asymptotic 95% confidence interval (CI) for the difference between groups (Synflorix PRE Group minus Synflorix I Group) was above 0%.|Difference in percentages|22.18|||||TWO_SIDED|95.0|11.78|32.11||||||||32.11|11.78|
71138489|NCT00527735|141776635|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.806||||0.1302|TWO_SIDED|95.0|0.553|1.174|||1-sided log rank|||||1.174|0.553|0.1302
71138490|NCT00527735|141776635|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.724||||0.0473|TWO_SIDED|95.0|0.495|1.059|||1-sided log rank|||||1.059|0.495|0.0473
71138491|NCT00527735|141776636|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.882||||0.2502|TWO_SIDED|95.0|0.612|1.271|||One-sided log rank|||||1.271|0.612|0.2502
71138492|NCT00527735|141776636|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.691||||0.024|TWO_SIDED|95.0|0.478|0.999|||One-sided log rank|||||0.999|0.478|0.0240
71138493|NCT00527735|141776637|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.988||||0.4759|TWO_SIDED|95.0|0.669|1.46|||1-sided log rank|||||1.460|0.669|0.4759
71138494|NCT00527735|141776637|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.866||||0.234|TWO_SIDED|95.0|0.587|1.278|||1-sided log rank|||||1.278|0.587|0.2340
71138495|NCT00527735|141776644|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.751||||0.1098|TWO_SIDED|95.0|0.475|1.188|||1-sided log rank|||||1.188|0.475|0.1098
71138496|NCT00527735|141776644|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.0282|TWO_SIDED|95.0|0.403|1.1016|||1-sided log rank|||||1.1016|0.403|0.0282
71138497|NCT00527735|141776653|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.933||||0.3846|TWO_SIDED|95.0|0.588|1.481|||1-sided Log Rank|||||1.481|0.588|0.3846
71138498|NCT00527735|141776653|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.927||||0.37|TWO_SIDED|95.0|0.591|1.453|||1-sided Log Rank|||||1.453|0.591|0.3700
71138499|NCT00527735|141776656|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.947||||0.4132|TWO_SIDED|95.0|0.585|1.536|||1-sided Log Rank|||||1.536|0.585|0.4132
71138500|NCT00527735|141776656|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.753||||0.1287|TWO_SIDED|95.0|0.461|1.232|||1-sided Log Rank|||||1.232|0.461|0.1287
71138501|NCT00904813|141776692|NON_INFERIORITY|In the initial protocol treatment groups were deemed non-inferior if the upper limit of a two-sided 90% CI for the hazard ratio did not exceed 1.7. With a cumulative incidence of local recurrence at 15%, a sample size of 840 participants were determined to provide a power of 80%. However, due to lower recurrence rate, the trial was re-powered in the amendment 1999 to deem non-inferiority at an HR not exceeding 2.5 or 3.6 depending on the frequency of local recurrence.|Hazard Ratio (HR)|0.38||||0.52|TWO_SIDED|90.0|0.06|2.56||The threshold for statistical significance was p=0.05.|Log Rank|An overall p-value was calculated.|SRT was used as reference group. Estimation described above is for SRT-delay. For LRT-delay HR (90% CI) was 1.22 with lower limit: 0.33, and upper limit: 3.45.|The effect of treatment regimen on local recurrence as first event in the three-armed group comparison (n = 385) was estimated with proportional hazards regression, stratified by participating centre.||2.56|0.06|0.52
71138502|NCT00904813|141776692|NON_INFERIORITY|In the initial protocol treatment groups were deemed non-inferior if the upper limit of a two-sided 90% CI for the hazard ratio did not exceed 1.7. With a cumulative incidence of local recurrence at 15%, a sample size of 840 participants were determined to provide a power of 80%. However, due to lower recurrence rate, the trial was re-powered in the amendment 1999 to deem non-inferiority at an HR not exceeding 2.5 or 3.6 depending on the frequency of local recurrence.|Hazard Ratio (HR)|0.93||||0.92|TWO_SIDED|95.0|0.64|1.35||The threshold for statistical significance was p=0.05.|Log Rank|An overall p-value was calculated.|SRT was used as reference group (1.00). Estimation described above is for SRT-delay. For LRT-delay HR (95% CI) was 0.99 with lower limit: 0.68, and upper limit: 1.42.|The effect of treatment regimen on recurrence-free survival in the three armed randomisation comparison (n = 385) was estimated with proportional hazards regression, stratified by participating centre.||1.35|0.64|0.92
70864321|NCT02124161|141214168|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.62|0.92||||||Serotype 14: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||0.92|0.62|
70864322|NCT02124161|141214168|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.64|1.06||||||Serotype 18C: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.06|0.64|
70864323|NCT02124161|141214168|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.72|1.04||||||Serotype 19A: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.04|0.72|
70864324|NCT02124161|141214168|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.71|1.14||||||Serotype 19F: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.14|0.71|
70864325|NCT02124161|141214168|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.56|1.03||||||Serotype 23F: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.03|0.56|
70864326|NCT02124161|141214169|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.88|1.18||||||Strain A/H1N1: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.18|0.88|
70864327|NCT02124161|141214169|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.2|||||TWO_SIDED|95.0|1.01|1.32||||||Strain A/H3N2: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.32|1.01|
70864328|NCT02124161|141214169|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.95|1.24||||||Strain B/Brisbane: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.24|0.95|
70864329|NCT02124161|141214169|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.9|1.21||||||Strain B/Massachusetts: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.21|0.90|
70864330|NCT02124161|141214172|SUPERIORITY_OR_OTHER||Percentage Difference|2.8|||||TWO_SIDED|95.0|-1.9|7.4||||||AE: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC+QIV /placebo - placebo+QIV/13vPnC, expressed as a percentage.||7.4|-1.9|
70864331|NCT02124161|141214172|SUPERIORITY_OR_OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.8|1.7||||||SAE: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC+QIV /placebo - placebo+QIV/13vPnC, expressed as a percentage.||1.7|-1.8|
70864332|NCT02124161|141214174|SUPERIORITY_OR_OTHER||Percentage Difference|-2.8||||0.333|TWO_SIDED|95.0|-8.3|2.8|||Chan and Zhang method|||Serotype 1: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||2.8|-8.3|0.333
70864333|NCT02124161|141214174|SUPERIORITY_OR_OTHER||Percentage Difference|-4.3||||0.105|TWO_SIDED|95.0|-9.6|0.9|||Chan and Zhang method|||Serotype 3: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||0.9|-9.6|0.105
70864334|NCT02124161|141214174|SUPERIORITY_OR_OTHER||Percentage Difference|-3.5||||0.09|TWO_SIDED|95.0|-7.6|0.6|||Chan and Zhang method|||Serotype 4: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||0.6|-7.6|0.090
70864335|NCT02124161|141214174|SUPERIORITY_OR_OTHER||Percentage Difference|1.8||||0.59|TWO_SIDED|95.0|-4.2|7.8|||Chan and Zhang method|||Serotype 5: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||7.8|-4.2|0.590
70864336|NCT02124161|141214174|SUPERIORITY_OR_OTHER||Percentage Difference|-3.7||||0.044|TWO_SIDED|95.0|-7.5|-0.1|||Chan and Zhang method|||Serotype 6A: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||-0.1|-7.5|0.044
70864337|NCT02124161|141214174|SUPERIORITY_OR_OTHER||Percentage Difference|-1.4||||0.574|TWO_SIDED|95.0|-6.2|3.4|||Chan and Zhang method|||Serotype 6B: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||3.4|-6.2|0.574
70864338|NCT02124161|141214174|SUPERIORITY_OR_OTHER||Percentage Difference|-1.2||||0.648|TWO_SIDED|95.0|-6.3|3.9|||Chan and Zhang method|||Serotype 7F: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||3.9|-6.3|0.648
70864339|NCT02124161|141214174|SUPERIORITY_OR_OTHER||Percentage Difference|-6.2||||0.057|TWO_SIDED|95.0|-12.5|0.2|||Chan and Zhang method|||Serotype 9V: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||0.2|-12.5|0.057
70864340|NCT02124161|141214174|SUPERIORITY_OR_OTHER||Percentage Difference|-3.7||||0.03|TWO_SIDED|95.0|-7.3|-0.3|||Chan and Zhang method|||Serotype 14: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||-0.3|-7.3|0.030
70864341|NCT02124161|141214174|SUPERIORITY_OR_OTHER||Percentage Difference|-2.5||||0.233|TWO_SIDED|95.0|-6.6|1.6|||Chan and Zhang method|||Serotype 18C: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||1.6|-6.6|0.233
71138503|NCT00904813|141776692|NON_INFERIORITY|In the initial protocol treatment groups were deemed non-inferior if the upper limit of a two-sided 90% CI for the hazard ratio did not exceed 1.7. With a cumulative incidence of local recurrence at 15%, a sample size of 840 participants were determined to provide a power of 80%. However, due to lower recurrence rate, the trial was re-powered in the amendment 1999 to deem non-inferiority at an HR not exceeding 2.5 or 3.6 depending on the frequency of local recurrence.|Hazard Ratio (HR)|0.91||||0.59|TWO_SIDED|90.0|0.36|2.27||The threshold for statistical significance was p=0.05.|Log Rank||SRT was used as reference group (1.00). Estimation described above is for SRT-delay.|The effect of treatment regimen on local recurrence as first event in the pooled short-course RT comparison (n = 712) was estimated with proportional hazards regression, stratified by participating centre.||2.27|0.36|0.59
71138504|NCT00904813|141776692|NON_INFERIORITY|In the initial protocol treatment groups were deemed non-inferior if the upper limit of a two-sided 90% CI for the hazard ratio did not exceed 1.7. With a cumulative incidence of local recurrence at 15%, a sample size of 840 participants were determined to provide a power of 80%. However, due to lower recurrence rate, the trial was re-powered in the amendment 1999 to deem non-inferiority at an HR not exceeding 2.5 or 3.6 depending on the frequency of local recurrence.|Hazard Ratio (HR)|0.9||||0.39|TWO_SIDED|95.0|0.69|1.18||The threshold for statistical significance was p=0.05.|Log Rank||SRT was used as reference group. Estimation described above is for SRT-delay.|The effect of treatment regimen on recurrence-free survival in the pooled short-course RT comparison (n = 712) was estimated with proportional hazards regression, stratified by participating centre.||1.18|0.69|0.39
70864342|NCT02124161|141214174|SUPERIORITY_OR_OTHER||Percentage Difference|-1.8||||0.152|TWO_SIDED|95.0|-4.5|0.7|||Chan and Zhang method|||Serotype 19A: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||0.7|-4.5|0.152
71138505|NCT00904813|141776693|SUPERIORITY||Odds Ratio (OR)|0.72||||0.289|TWO_SIDED|95.0|0.4|1.32||The threshold of statistical significance was p=0.05.|Regression, Logistic|Model was adjusted for sex, age over 75 years, type of surgery and ASA fitness grade.|Group B was used as the reference group.|The association between postoperative complications and short-course RT by overall treatment time was assessed using logistic regression analysis.||1.32|0.40|0.289
71138506|NCT00904813|141776693|SUPERIORITY||Odds Ratio (OR)|0.5||||0.009|TWO_SIDED|95.0|0.3|0.84||The threshold for statistical significance was p=0.05.|Regression, Logistic|Model was adjusted for sex, age over 75 years, type of surgery and ASA fitness grade.|Group B was used as the reference group.|The association between postoperative complications and short-course RT by overall treatment time was assessed using logistic regression analysis.||0.84|0.30|0.009
71138507|NCT00904813|141776693|SUPERIORITY||Odds Ratio (OR)|0.39|||<|0.001|TWO_SIDED|95.0|0.23|0.65||The threshold for statistical significance was p-value=0.05.|Regression, Logistic|Model was adjusted for sex, age over 75 years, type of surgery and ASA fitness grade.|Group B was used as the reference group.|The association between postoperative complications and short-course RT by overall treatment time was assessed using logistic regression analysis.||0.65|0.23|<0.001
70864343|NCT02124161|141214174|SUPERIORITY_OR_OTHER||Percentage Difference|0.3||||0.926|TWO_SIDED|95.0|-5.1|5.8|||Chan and Zhang method|||Serotype 19F: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||5.8|-5.1|0.926
71138508|NCT00904813|141776693|SUPERIORITY||Odds Ratio (OR)|1.58||||0.521|TWO_SIDED|95.0|0.39|6.37||The threshold for statistical significance was p-value = 0.05.|Regression, Logistic|Model was adjusted for sex, age over 75 years, type of surgery and ASA fitness grade.|Group E was used as the reference group.|The association between postoperative complications and long-course RT by overall treatment time was assessed using logistic regression analysis.||6.37|0.39|0.521
71138509|NCT00904813|141776694|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.046|TWO_SIDED|95.0|0.26|0.99||The threshold for statistical significance was p=0.05.|Regression, Cox|Model adjusted for age, sex and type of surgery.|No pCR was used as reference group.|The association between pathological complete response (pCR), eg no signs of viable tumour or metastatic nodes (T0N0) and overall survival (OS) was assessed using Cox-regression model.||0.99|0.26|0.046
70864344|NCT02124161|141214174|SUPERIORITY_OR_OTHER||Percentage Difference|-3.9||||0.143|TWO_SIDED|95.0|-9.1|1.3|||Chan and Zhang method|||Serotype 23F: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||1.3|-9.1|0.143
70864345|NCT02124161|141214177|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|Percentage Difference|5.1||||0.094|TWO_SIDED|95.0|-0.9|11.0|||Chan and Zhang method|||Strain A/H1N1: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||11.0|-0.9|0.094
71138510|NCT02271698|141776702|SUPERIORITY_OR_OTHER|||||||0.052||||||6 hour pain at rest|t-test, 2 sided|||||||0.052
71138511|NCT02271698|141776702|SUPERIORITY_OR_OTHER|||||||0.064||||||6 hour pain with movement|t-test, 2 sided|||||||0.064
71138512|NCT02271698|141776702|SUPERIORITY_OR_OTHER|||||||0.139|||||||t-test, 2 sided|12 hour pain at rest||||||0.139
71138513|NCT02271698|141776702|SUPERIORITY_OR_OTHER|||||||0.35||||||12 hour pain at rest|t-test, 2 sided|||||||0.350
71138514|NCT02271698|141776702|SUPERIORITY_OR_OTHER|||||||0.021||||||18 hour pain at rest|t-test, 2 sided|||||||0.021
71138515|NCT02271698|141776702|SUPERIORITY_OR_OTHER|||||||0.198||||||18 hour pain with movement|t-test, 2 sided|||||||0.198
71138516|NCT02271698|141776702|SUPERIORITY_OR_OTHER|||||||0.806|||||||t-test, 2 sided|24 hour pain at rest||||||0.806
71138517|NCT02271698|141776702|SUPERIORITY_OR_OTHER|||||||0.228||||||24 hour pain with movement|t-test, 2 sided|||||||0.228
71138518|NCT02271698|141776702|SUPERIORITY_OR_OTHER|||||||0.457||||||36 hour pain at rest|t-test, 2 sided|||||||0.457
71138519|NCT02271698|141776702|SUPERIORITY_OR_OTHER|||||||0.394||||||36 hour pain with movement|t-test, 2 sided|||||||0.394
71138520|NCT02271698|141776703|SUPERIORITY_OR_OTHER|||||||0.181||||||6 hours|t-test, 2 sided|||||||0.181
71138521|NCT02271698|141776703|SUPERIORITY_OR_OTHER|||||||0.364||||||12 hours|t-test, 2 sided|||||||0.364
71138522|NCT02271698|141776703|SUPERIORITY_OR_OTHER|||||||0.605|||||||t-test, 2 sided|18 hours||||||0.605
71138523|NCT02271698|141776703|SUPERIORITY_OR_OTHER|||||||0.733|||||||t-test, 2 sided|24 hours||||||0.733
71138524|NCT02271698|141776703|SUPERIORITY_OR_OTHER|||||||0.6||||||36 hours|t-test, 2 sided|||||||0.600
71138525|NCT03985761|141776719|SUPERIORITY|||||||0.182|||||||ANOVA|||||||.182
71138526|NCT03985761|141776720|SUPERIORITY|||||||0.296|||||||ANOVA|||||||.296
71138527|NCT03985761|141776721|SUPERIORITY|||||||0.483|||||||ANOVA|||||||.483
71138528|NCT03985761|141776722|SUPERIORITY|||||||0.995|||||||ANOVA|||||||.995
71138529|NCT03985761|141776723|SUPERIORITY|||||||0.22|||||||ANOVA|||||||.220
71138530|NCT03985761|141776724|SUPERIORITY|||||||0.538|||||||ANOVA|||||||.538
71138531|NCT03985761|141776727|SUPERIORITY|||||||0.121|||||||ANOVA|||||||.121
71138532|NCT05757648|141776738|SUPERIORITY|||||||0.005|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.005
71138533|NCT05757648|141776739|SUPERIORITY|||||||0.775|||||||Mixed Models Analysis|||||||0.775
71138534|NCT05757648|141776740|SUPERIORITY|||||||0.682|||||||Mixed Models Analysis|||||||0.682
71138535|NCT02920892|141776805|SUPERIORITY||Slope|-0.1||||0.1587|TWO_SIDED|90.0|-0.22|0.02|||Mixed Models Analysis|||||0.02|-0.22|0.1587
71138536|NCT02920892|141776806|SUPERIORITY||Slope|-1.66||||0.1054|TWO_SIDED|90.0|-3.34|0.03|||Mixed Models Analysis|||||0.03|-3.34|0.1054
71138537|NCT02920892|141776807|SUPERIORITY||Slope|-0.67||||0.32|TWO_SIDED|90.0|-1.79|0.45|||Mixed Models Analysis|||||0.45|-1.79|0.32
71138538|NCT02920892|141776808|SUPERIORITY||Slope|-0.29||||0.78|TWO_SIDED|90.0|-1.98|1.4|||Mixed Models Analysis|||||1.4|-1.98|0.78
71138539|NCT02920892|141776809|SUPERIORITY||Slope|0.1||||0.94|TWO_SIDED|90.0|-2.05|2.24|||Mixed Models Analysis|||||2.24|-2.05|0.94
71138540|NCT02920892|141776810|SUPERIORITY||Slope|-0.85||||0.1428|TWO_SIDED|90.0|-1.81|0.11|||Mixed Models Analysis|||||0.11|-1.81|0.1428
71138541|NCT02920892|141776811|SUPERIORITY||Odds Ratio (OR)|0.9462||||0.24|TWO_SIDED|90.0|0.8764|1.0215|||Mixed Models Analysis|||||1.0215|0.8764|0.24
71138542|NCT02920892|141776812|SUPERIORITY||Odds Ratio (OR)|0.95||||0.92|TWO_SIDED|90.0|0.4|2.27|||Mixed Models Analysis|||||2.27|0.4|0.92
71138543|NCT03649217|141776829|SUPERIORITY|||||||0.0001|||||||ANOVA|||||||.0001
71138544|NCT03649217|141776830|SUPERIORITY|||||||0.0001|||||||ANOVA|||||||.0001
71138545|NCT03649217|141776831|SUPERIORITY|||||||0.001|||||||ANOVA|||||||.001
71138546|NCT03649217|141776832|SUPERIORITY|||||||0.0002|||||||ANOVA|||||||.0002
71138547|NCT03649217|141776833|SUPERIORITY|||||||0.006|||||||ANOVA|||||||.006
71138548|NCT02552966|141776836|OTHER|||||||0.61|||||||t-test, 2 sided|This t-test was applied to determine if the mean salivary pepsin concentration changed between baseline and 2 week post UESAD measurements.||||||0.61
71138549|NCT02552966|141776837|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71138550|NCT02552966|141776838|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71138551|NCT02552966|141776839|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71138552|NCT00721396|141776842|NON_INFERIORITY_OR_EQUIVALENCE|Immune response of Group B+R246 was considered non-inferior to response of Group B246\_R357, if at one month after the third rMenB+OMV NZ injection the 2-sided 95% lower confidence interval of the difference in the percentage of subjects with hSBA titer ≥1:5 was greater than -10% for each of the 3 strains.|Difference % (B+R246 minus B246_R357)|0.0|||||TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against 44/76-SL strain when rMenB+OMV NZ vaccine was administered concomitantly with routine infant vaccines as compared to when rMenB+OMV NZ vaccine and routine vaccines were given separately.||1|-1|
71138553|NCT00721396|141776842|NON_INFERIORITY_OR_EQUIVALENCE|Immune response of Group B+R246 was considered non-inferior to response of Group B246\_R357, if at one month after the third rMenB+OMV NZ injection the 2-sided 95% lower confidence limit of the difference in the percentage of subjects with hSBA titer ≥5 was greater than -10% for each of the 3 strains.|Difference %(B+R246 minus B246_R357)|0.0|||||TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against 5/99 strain when rMenB+OMV NZ vaccine was administered concomitantly with routine infant vaccines as compared to when rMenB+OMV NZ vaccine and routine vaccines were given separately.||1|-1|
71138554|NCT00721396|141776842|NON_INFERIORITY_OR_EQUIVALENCE|Immune response of Group B+R246 was considered non-inferior to response of Group B246\_R357, if at one month after the third rMenB+OMV NZ injection the 2-sided 95% lower confidence limit of the difference in the percentage of subjects with hSBA titer ≥5 was greater than -10% for each of the 3 strains.|Difference % (B+R246 minus B246_R357)|-8.0|||||TWO_SIDED|95.0|-12.0|-4.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against NZ98/254 strain when rMenB+OMV NZ vaccine was administered concomitantly with routine infant vaccines as compared to when rMenB+OMV NZ vaccine and routine vaccines were given separately.||-4|-12|
70864346|NCT02124161|141214177|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|Percentage Difference|-3.8||||0.232|TWO_SIDED|95.0|-9.9|2.4|||Chan and Zhang method|||Strain A/H3N2: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||2.4|-9.9|0.232
71138555|NCT00721396|141776843|NON_INFERIORITY_OR_EQUIVALENCE|Immune response of Group B+R234 was considered non-inferior to response of Group R234, if at one month after the third injection the 2-sided 95% lower confidence limit for the difference in the percentage of subjects with antibody response greater than the pre-specified cut off of for diphtheria (≥0.1 IU/mL) was \>-10%.|Difference %(B+R234 minus R234)|0.0|||||TWO_SIDED|95.0|-1.0|2.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against Diphtheria antigen when routine vaccine was administered concomitantly with rMenB+OMV NZ vaccine to when only routine vaccines were administered.||2|-1|
71138556|NCT00721396|141776843|NON_INFERIORITY_OR_EQUIVALENCE|Immune response of Group B+R234 was considered non-inferior to response of Group R234, if at one month after the third injection the 2-sided 95% lower confidence limit for the difference in the percentage of subjects with antibody response greater than the pre-specified cut off of for tetanus toxoid (≥0.1 IU/mL) was \>-10%.|Difference %(B+R234 minus R234)|0.0|||||TWO_SIDED|95.0|-1.0|2.0|||Miettinen and Nurminen|||Non-inferiority of immune response to Tetanus antigens when routine vaccines are administered concomitantly with rMen+OMV NZ vaccine.||2|-1|
71138557|NCT00721396|141776848|NON_INFERIORITY_OR_EQUIVALENCE|Group B+R234 was to be considered non-inferior to Group R234 if the 2-sided 95% lower confidence limit of this difference at 30 days after the last injection was greater than -10% for each of the antigens of the routine vaccinations.|Difference %(B+R234 minus R234)|-1.0|||||TWO_SIDED|95.0|-5.0|4.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against Pertussis antigen FHA when routine vaccine was administered concomitantly with rMenB+OMV NZ vaccine to when only routine vaccines were administered.||4|-5|
71138558|NCT00721396|141776848|NON_INFERIORITY_OR_EQUIVALENCE|Group B+R234 was to be considered non-inferior to Group R234 if the 2-sided 95% lower confidence limit of this difference at 30 days after the last injection was greater than -10% for each of the antigens of the routine vaccinations.|Difference %(B+R234 minus R234)|-2.0|||||TWO_SIDED|95.0|-7.0|2.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against Pertussis antigen pertactin antigen when routine vaccine was administered concomitantly with rMenB+OMV NZ vaccine to when only routine vaccines were administered.||2|-7|
71138559|NCT00721396|141776848|NON_INFERIORITY_OR_EQUIVALENCE|Group B+R234 was to be considered non-inferior to Group R234 if the 2-sided 95% lower confidence limit of this difference at 30 days after the last injection was greater than -10% for each of the antigens of the routine vaccinations.|Difference %(B+R234 minus R234)|-1.0|||||TWO_SIDED|95.0|-4.0|2.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against Pertussis antigen PT when routine vaccine was administered concomitantly with rMenB+OMV NZ vaccine to when only routine vaccines were administered.||2|-4|
71138560|NCT00614380|141776854|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.34||||||95.0|0.22|0.53|||Cochran-Mantel-Haenszel|||||0.53|0.22|
71138561|NCT00614380|141776854|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.31||||||95.0|0.12|0.81|||Cochran-Mantel-Haenszel|||||0.81|0.12|
71138562|NCT00614380|141776854|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.08||||||95.0|0.06|0.13|||Cochran-Mantel-Haenszel|||||0.13|0.06|
71138563|NCT00614380|141776854|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||||95.0|0.34|2.41|||Cochran-Mantel-Haenszel|||||2.41|0.34|
71138564|NCT00614380|141776854|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.25||||||95.0|0.16|0.39|||Cochran-Mantel-Haenszel|||||0.39|0.16|
71138565|NCT00614380|141776854|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||||95.0|0.1|0.72|||Cochran-Mantel-Haenszel|||||0.72|0.10|
71138566|NCT03865446|141776882|OTHER||Geometric Means Ratio|130.91|||||TWO_SIDED|90.0|86.03|199.22|||||The model was an analysis of variance (ANOVA) model with unequal variance assumption and hepatic impairment group as fixed effect. Values were back-transformed from the log scale.|||199.22|86.03|
71138567|NCT03865446|141776883|OTHER||Geometric Means Ratio|104.41|||||TWO_SIDED|90.0|72.12|151.16|||||The model was an ANOVA model with unequal variance assumption and hepatic impairment group as fixed effect. Values are back-transformed from the log scale.|||151.16|72.12|
71138568|NCT02021565|141776899|SUPERIORITY|||||||0.973||||||alpha = 0.025|ANOVA|Repeated measures||Analysis 1 is for the caregiver reported confidence that Veteran care recipient can perform 10 transfer tasks with assistance from the informal caregiver.||||0.973
71138569|NCT02021565|141776899|SUPERIORITY|Alpha = .025||||||0.223|||||||ANOVA|||Analysis 2 is for the caregiver reported confidence that Veteran care recipient can perform 10 transfer tasks independently.||||0.223
70864347|NCT02124161|141214177|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|Percentage Difference|-1.0||||0.734|TWO_SIDED|95.0|-6.6|4.5|||Chan and Zhang method|||Strain B/Brisbane: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||4.5|-6.6|0.734
71138570|NCT02021565|141776900|SUPERIORITY|||||||0.547|||||||ANOVA|||Analysis 1 is for the Veteran care recipient reported task efficacy||||0.547
71138571|NCT02021565|141776900|SUPERIORITY|||||||0.891|||||||ANOVA|||Analysis 2 is for the Veteran reported confidence that he/she can perform 10 transfer tasks independently.||||0.891
71138572|NCT02021565|141776901|SUPERIORITY|||||||0.729|||||||ANOVA|||||||0.729
71138573|NCT03318549|141776902|OTHER|||||||0.011|||||||t-test, 2 sided|||||||0.011
71138574|NCT03318549|141776902|OTHER|||||||0.022|||||||t-test, 2 sided|||||||0.022
71138575|NCT03318549|141776903|OTHER|||||||0.303|||||||Chi-squared|||||||0.303
71138576|NCT03318549|141776906|OTHER|||||||0.132|||||||t-test, 2 sided|||||||0.132
71138577|NCT03318549|141776906|OTHER|||||||0.647|||||||t-test, 2 sided|||||||0.647
71138578|NCT00607087|141776922|SUPERIORITY_OR_OTHER|||||||0.039||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.039
71138579|NCT00607087|141776922|SUPERIORITY_OR_OTHER|||||||0.031||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025.|McNemar|||||||0.031
70864348|NCT02124161|141214177|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|Percentage Difference|-1.5||||0.627|TWO_SIDED|95.0|-7.2|4.3|||Chan and Zhang method|||Strain B/Massachusetts: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||4.3|-7.2|0.627
71138580|NCT00607087|141776923|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||<0.001
71138581|NCT00607087|141776923|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||<0.001
71138582|NCT00607087|141776924|SUPERIORITY_OR_OTHER|||||||0.08||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.080
71138583|NCT00607087|141776924|SUPERIORITY_OR_OTHER|||||||0.107||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.107
71138584|NCT00607087|141776925|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||<0.001
71138585|NCT00607087|141776925|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||<0.001
71138586|NCT00607087|141776926|SUPERIORITY_OR_OTHER|||||||0.079||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.079
71138587|NCT00607087|141776926|SUPERIORITY_OR_OTHER|||||||0.063||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.063
71138588|NCT00607087|141776927|SUPERIORITY_OR_OTHER|||||||0.015||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.015
71138589|NCT00607087|141776927|SUPERIORITY_OR_OTHER|||||||0.073||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.073
71138590|NCT00607087|141776928|SUPERIORITY_OR_OTHER|||||||0.017||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.017
71138591|NCT00607087|141776928|SUPERIORITY_OR_OTHER|||||||0.032||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.032
70864349|NCT01147640|141214199|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-12.4|||||TWO_SIDED|||||||||||||
70864350|NCT01147640|141214200|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-5.2|||||TWO_SIDED|95.0||||||||||||
70864351|NCT01950169|141214242|SUPERIORITY|||||||0.05|||||||ANCOVA|Covariates used were age, sex, total mass, and baseline BMD. Data were reported using complete-cases analysis and intention-to-treat (ITT) analysis.||||||0.05
70864352|NCT01950169|141214243|SUPERIORITY|||||||0.05|||||||ANCOVA|Covariates used were age, sex, total mass, and baseline BMD. Data were reported using complete-cases analysis and intention-to-treat (ITT) analysis.||||||0.05
70864353|NCT01950169|141214244|SUPERIORITY|||||||0.05|||||||ANCOVA|The analyses included exposure measures treatment groups and sex as fixed factors. Age and baseline values for FFMI, FMI were included as covariates.||||||0.05
70864354|NCT01680887|141214251|SUPERIORITY|||||||0.403|||||||Chi-squared|||||||.403
71138592|NCT00607087|141776929|SUPERIORITY_OR_OTHER|||||||0.009||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.009
71138593|NCT00607087|141776929|SUPERIORITY_OR_OTHER|||||||0.019||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.019
71138594|NCT00607087|141776930|SUPERIORITY_OR_OTHER|||||||0.008||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.008
71138595|NCT00607087|141776930|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||<0.001
71138596|NCT00607087|141776931|SUPERIORITY_OR_OTHER|||||||0.563||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.563
71138597|NCT00607087|141776931|SUPERIORITY_OR_OTHER|||||||0.186||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.186
71138598|NCT00607087|141776932|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||<0.001
71138599|NCT00607087|141776932|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||<0.001
71138600|NCT00607087|141776933|SUPERIORITY_OR_OTHER|||||||1||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||1.000
71138601|NCT00607087|141776933|SUPERIORITY_OR_OTHER|||||||0.701||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.701
71138602|NCT00607087|141776936|SUPERIORITY_OR_OTHER|||||||0.078||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|ANCOVA|ANCOVA adjusted on HbA1c value at the start of the first period||||||0.078
71138603|NCT00607087|141776936|SUPERIORITY_OR_OTHER|||||||0.938||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|ANCOVA|ANCOVA adjusted on HbA1c level at the start of the first period||||||0.938
71138604|NCT01774799|141777065|SUPERIORITY||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.69|1.69||||||||1.69|0.69|
71138605|NCT01774799|141777066|SUPERIORITY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.66|2.2||||||||2.20|0.66|
71138606|NCT01774799|141777067|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.58|1.58||||||||1.58|0.58|
71138607|NCT01774799|141777068|SUPERIORITY||Odds Ratio (OR)|1.79|||||TWO_SIDED|95.0|1.13|2.82||||||||2.82|1.13|
71138608|NCT01774799|141777069|SUPERIORITY|||||||0.32|||||||Regression, Linear|||||||0.32
71138609|NCT02586623|141777070|SUPERIORITY||Cox Proportional Hazard|1.04||||0.803|TWO_SIDED|95.0|0.67|1.62|||Log Rank||Droxidopa / Placebo|||1.62|0.67|0.803
70872185|NCT02495168|141229590|EQUIVALENCE|To show the clinical equivalence, an ANCOVA model was fit on the participants from the generic budesonide/formoterol fumarate and Symbicort groups only, with the endpoint as outcome and treatment, study site and treatment-by site interaction as fixed effects and FEV1 baseline value as covariate. If the treatment-by-site interaction factor was not significant at the 0.05 level, the model was to be rerun without the interaction term.|Test/Reference LS Mean Ratio|99.8|||||TWO_SIDED|90.0|87.0|114.5|||||Fieller's formula was applied to calculate the 90% CI for the generic budesonide/formoterol fumarate and Symbicort LS mean ratio; covariance between treatment means was assumed to be 0.|||114.5|87.0|
71138610|NCT00965250|141777113|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Kaplan Meier|||||||<0.0001
71138611|NCT00965250|141777114|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Kaplan Meier|||||||<0.0001
71138612|NCT00479713|141777125|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.72|STANDARD_ERROR_OF_MEAN|1.72|<=|0.001||95.0|-14.1|-7.33|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center||||-7.33|-14.10|<=0.001
71138613|NCT00479713|141777126|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.1|||<=|0.001||95.0|1.5|3.0|||Regression, Logistic|Model terms: treatment, stratum and baseline LDL-C (continuous)||Percentage of Participants who Attained Target LDL-C Goal of \< 100 mg/dL (2.59 mmol/L)||3.0|1.5|<=0.001
71138614|NCT00479713|141777126|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.8|||<=|0.001||95.0|1.8|4.4|||Regression, Logistic|Model terms: treatment, stratum and baseline LDL-C (continuous)||Percentage of Participants who Attained Target LDL-C Goal of \< 70 mg/dL (1.81 mmol/L)||4.4|1.8|<=0.001
71138615|NCT00479713|141777127|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.2|STANDARD_ERROR_OF_MEAN|1.2|<=|0.001||95.0|-9.56|-4.84|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center||||-4.84|-9.56|<=0.001
70864355|NCT02963935|141214291|SUPERIORITY|The treatment policy estimand evaluated the treatment effect (liraglutide 3.0 mg vs placebo) at week 56 for all randomised subjects regardless of premature discontinuation of trial product.|Treatment difference|-3.45||||0.0003|TWO_SIDED|95.0|-5.31|-1.59|||ANCOVA|Missing observations were imputed from the placebo arm based on a jump to reference (x100) multiple imputation approach.|Liraglutide 3.0 mg - placebo|Treatrment policy estimand. The hypothesis and the alternative are: H: μliraglutide ≥ μplacebo against the alternative HA: μliraglutide \< μplacebo. μliraglutide and μplacebo denote the true mean of % weight change for liraglutide 3.0 mg and placebo group, respectively. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline body weight as covariate.||-1.59|-5.31|0.0003
70864356|NCT02963935|141214291|OTHER|The hypothetical estimand evaluated the treatment effect (liraglutide 3.0 mg vs placebo) for all randomised subjects assuming that all subjects remained on trial product (on-treatment principle)|Treatment difference|-4.59||||0|TWO_SIDED|95.0|-6.54|-2.64|||Mixed models repeated measurement (MMRM)||Liraglutide 3.0 mg - placebo|Hypothetical estimand. Analysis of on-drug data before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline body weight as covariate, all nested within visit.||-2.64|-6.54|0.0000
70864357|NCT02963935|141214292|SUPERIORITY||Odds Ratio (OR)|2.51||||0.0003|TWO_SIDED|95.0|1.53|4.14|||Regression, Logistic||Liraglutide 3.0 mg/Placebo|Treatment policy estimand. Week 56 responses were analysed using a logistic regression model with treatment, BMI groups, and sex as factors and baseline body weight as covariate. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach.||4.14|1.53|0.0003
70864358|NCT02963935|141214292|OTHER||Odds Ratio (OR)|2.84||||0|TWO_SIDED|95.0|1.75|4.61|||Mixed models repeated measurement (MMRM)||Liraglutide 3.0 mg/placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline body weight as covariate, all nested within visit. The MMRM was used to classify responders and analysed with a logistic regression with treatment as the only factor.||4.61|1.75|0.0000
71138616|NCT00479713|141777128|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-5.06||||0.056||95.0|-9.56|-0.3|||Nonparametric ANOVA|ANOVA model based on Tukey's normalized ranks with term for treatment, stratum, baseline (categorized based on quartiles) and center.|The median difference between treatments is based on the Hodges-Lehmann estimates of shift with a corresponding distribution-free Confidence Interval (CI) based on Wilcoxon's rank.|||-0.30|-9.56|0.056
71138617|NCT00479713|141777129|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|1.17||0.433||95.0|-3.21|1.38|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center.||||1.38|-3.21|0.433
71138618|NCT00479713|141777130|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.41|STANDARD_ERROR_OF_MEAN|1.58|<=|0.001||95.0|-12.5|-6.31|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center.||||-6.31|-12.50|<=0.001
71138619|NCT00479713|141777131|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.59|STANDARD_ERROR_OF_MEAN|1.98|<=|0.001||95.0|-13.49|-5.69|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center.||||-5.69|-13.49|<=0.001
71138620|NCT00479713|141777132|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.25|STANDARD_ERROR_OF_MEAN|1.44|<=|0.001||95.0|-9.07|-3.43|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center.||||-3.43|-9.07|<=0.001
71138621|NCT00479713|141777133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.11|STANDARD_ERROR_OF_MEAN|1.43|<=|0.001||95.0|-10.91|-5.3|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center||||-5.30|-10.91|<=0.001
71138622|NCT00479713|141777134|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.67||||0.172||95.0|-16.67|2.87|||Nonparametric ANOVA|ANOVA model based on Tukey's normalized ranks with term for treatment, stratum, baseline (categorized based on quartiles) and center|The median difference between treatments is based on the Hodges-Lehmann estimates of shift with a corresponding distribution-free CI based on Wilcoxon's rank|||2.87|-16.67|0.172
71138623|NCT00141102|141777135|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.32|||<|0.0001|TWO_SIDED||||||Life Table Extension|Stratified by history of GD ulceration and by region.||||||<0.0001
71138624|NCT00141102|141777136|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.93|||<|0.0001|TWO_SIDED||||||Life Table Extension|Stratified by history of GD ulceration and by region.||||||<0.0001
71138625|NCT00141102|141777137|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.019|STANDARD_ERROR_OF_MEAN|0.023||0.4146|TWO_SIDED|95.0|-0.06|0.03|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.||||0.03|-0.06|0.4146
71138626|NCT00141102|141777138|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.29||||0.1132|TWO_SIDED||||||Life Table Extension|Stratified by history of GD ulceration and by region.||||||0.1132
71138627|NCT00141102|141777140|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.26||||0.0495|TWO_SIDED||||||Life Table Extension|Stratified by history of GD ulceration and by region.||||||0.0495
71138628|NCT00141102|141777141|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.52||||0.0006|TWO_SIDED||||||Life Table Extension|Stratified by history of GD ulceration and by region.||||||0.0006
71138629|NCT00141102|141777142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.406|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.36|0.45|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.||||0.45|0.36|<0.0001
71138630|NCT00141102|141777143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.118|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001|TWO_SIDED|95.0|0.98|1.25|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.||||1.25|0.98|<0.0001
71138631|NCT00141102|141777144|SUPERIORITY_OR_OTHER_LEGACY||Relative Risk|2.748|||<|0.0001|TWO_SIDED|95.0|1.96|3.84|||Cochran-Mantel-Haenszel|Stratified by history of GD ulceration and by region.||||3.84|1.96|<0.0001
71138632|NCT00141102|141777145|SUPERIORITY_OR_OTHER_LEGACY||Relative Risk|3.329|||<|0.0001|TWO_SIDED|95.0|2.156|5.141|||Fisher Exact|||GGT||5.141|2.156|<0.0001
71138633|NCT00141102|141777145|SUPERIORITY_OR_OTHER_LEGACY||Relative Risk|1.509||||0.3809|TWO_SIDED|95.0|0.618|3.684|||Fisher Exact|||AST||3.684|0.618|0.3809
71138634|NCT00141102|141777145|SUPERIORITY_OR_OTHER_LEGACY||Relative Risk|2.089||||0.0264|TWO_SIDED|95.0|1.081|4.038|||Fisher Exact|||ALT||4.038|1.081|0.0264
71138635|NCT00141102|141777146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-10.144|STANDARD_ERROR_OF_MEAN|0.697|<|0.0001|TWO_SIDED|95.0|-11.51|-8.78|||ANCOVA|||GGT||-8.78|-11.51|<0.0001
71138636|NCT00141102|141777146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.391|STANDARD_ERROR_OF_MEAN|0.281|<|0.0001|TWO_SIDED|95.0|-2.94|-1.84|||ANCOVA|||AST||-1.84|-2.94|<0.0001
71138637|NCT00141102|141777146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.364|STANDARD_ERROR_OF_MEAN|0.428|<|0.0001|TWO_SIDED|95.0|-7.2|-5.52|||ANCOVA|||ALT||-5.52|-7.20|<0.0001
71138638|NCT00141102|141777147|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.565|STANDARD_ERROR_OF_MEAN|1.366||0.6795|TWO_SIDED|95.0|-2.11|3.24|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.||||3.24|-2.11|0.6795
71138639|NCT00141102|141777148|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.406|STANDARD_ERROR_OF_MEAN|2.624||0.592|TWO_SIDED|95.0|-6.55|3.74|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.||||3.74|-6.55|0.5920
71138640|NCT00141102|141777149|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.015|STANDARD_ERROR_OF_MEAN|0.038||0.6819|TWO_SIDED|95.0|-0.09|0.06|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.||||0.06|-0.09|0.6819
71138641|NCT03400475|141777152|SUPERIORITY||Mean Difference (Final Values)|-2.088||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.90
71138642|NCT03400475|141777153|SUPERIORITY||Mean Difference (Final Values)|3.59||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.90
71138643|NCT03400475|141777154|SUPERIORITY||Mean Difference (Final Values)|3.596||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.90
71138644|NCT03400475|141777155|SUPERIORITY||Mean Difference (Final Values)|-0.083||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.90
71138645|NCT03400475|141777156|SUPERIORITY||Mean Difference (Final Values)|0.581||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.90
71138646|NCT03400475|141777157|SUPERIORITY||Mean Difference (Final Values)|0.029||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.90
71138647|NCT03400475|141777158|SUPERIORITY||Mean Difference (Final Values)|-64.696||||0.86|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.86
71138648|NCT03400475|141777159|SUPERIORITY||Mean Difference (Final Values)|111.03||||0.86|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.86
71138649|NCT03400475|141777160|SUPERIORITY||Mean Difference (Final Values)|213.314||||0.86|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.86
71138650|NCT03400475|141777161|SUPERIORITY||Mean Difference (Final Values)|37.356||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.41
71138651|NCT03400475|141777162|SUPERIORITY||Mean Difference (Final Values)|1.6537||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.41
71138652|NCT03400475|141777163|SUPERIORITY||Mean Difference (Final Values)|1.552||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.41
71138653|NCT03400475|141777164|SUPERIORITY|||||||0.071|||||||Fisher Exact|||||||0.071
71138654|NCT03400475|141777165|SUPERIORITY|||||||0.071|||||||Fisher Exact|||||||0.071
71138655|NCT03400475|141777166|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
71138656|NCT03400475|141777167|SUPERIORITY|||||||0.062|||||||Fisher Exact|||||||0.062
71138657|NCT03400475|141777168|SUPERIORITY|||||||0.54|||||||Fisher Exact|||||||0.54
71138658|NCT03400475|141777169|SUPERIORITY|||||||0.34|||||||Fisher Exact|||||||0.34
71138659|NCT02649556|141777195|OTHER||LS Mean Difference|1.75|||||TWO_SIDED|95.0|-0.16|3.65||||||"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of LS Mean difference of HDL-C levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on original values with visit, baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect.|3.65|-0.160|
71138660|NCT02649556|141777196|OTHER||LS Mean Difference|-0.413|||||TWO_SIDED|95.0|-0.694|-0.131||||||"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of LS Mean difference of White Blood Cell counts between CC and THS 2.2 and related 95% CI."|Mixed model conducted on original values with visit, baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect.|-0.131|-0.694|
71138661|NCT02649556|141777197|OTHER||LS Mean Difference|0.914|||||TWO_SIDED|95.0|-0.339|2.17||||||"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of LS Mean difference of FEV1 levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on original values with visit, baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect.|2.17|-0.339|
71138662|NCT02649556|141777198|OTHER||% Relative Reduction|3.11|||||TWO_SIDED|95.0|0.0231|6.1|||||Derived as 100 x (1 - Geometric LS Mean Ratio)|"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of relative reduction of sICAM-1 levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on log-transformed values with visit, log-transformed baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect|6.10|0.0231|
70948072|NCT00267098|141396987|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.564|||||TWO_SIDED|95.0|-2.843|1.773||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in MR through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean MR change through 12 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Mitral Regurgitation (MR) through 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Mitral Regurgitation through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value.||1.773|-2.843|
71138663|NCT02649556|141777199|OTHER||% Relative Reduction|3.44|||||TWO_SIDED|95.0|-8.74|14.3|||||Derived as 100 x (1-Geometric LS Mean Ratio)|"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of relative reduction of 11-DTXB2 levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on log-transformed values with visit, log-transformed baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect|14.3|-8.74|
71138664|NCT02649556|141777200|OTHER||% Relative Reduction|7.15|||||TWO_SIDED|95.0|-1.03|14.7|||||Derived as 100 x (1 - Geometric LS Mean Ratio)|"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of relative reduction of 8-epi-PGF2α levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on log-transformed values with visit, log-transformed baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect.|14.7|-1.03|
71138665|NCT02649556|141777201|OTHER||% Relative Reduction|46.3|||||TWO_SIDED|95.0|36.2|54.8|||||Derived as 100 x (1 - Geometric LS Mean Ratio)|"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of relative reduction of Total NNAL levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on log-transformed values with visit, log-transformed baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect|54.8|36.2|
71138666|NCT02649556|141777202|OTHER||% Relative Reduction|31.7|||||TWO_SIDED|95.0|23.3|39.1|||||Derived as 100 x (1 - Geometric LS Mean Ratio)|"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of relative reduction of COHb levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on log-transformed values with visit, log-transformed baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect.|39.1|23.3|
71138667|NCT02413918|141777204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9|STANDARD_DEVIATION|20.0|<|0.0094|TWO_SIDED|||||p value is not adjusted for multiple comparisons (see above). A priori threshold for significance was p\<0.05.|t-test, 2 sided|||BISS Outcomes: Mean changes in depression and mania for study completers were measured. The a priori hypothesis was a mean change of 50%.||||<0.0094
71138668|NCT02413918|141777204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.4|STANDARD_DEVIATION|10.1|<|0.0001|TWO_SIDED||||||t-test, 2 sided|||BISS Outcomes: Mean changes in mania for study completers were measured. The a priori hypothesis was a mean change of 50%.||||<0.0001
71138669|NCT01342913|141777219|SUPERIORITY_OR_OTHER||Least squares mean difference|0.022||||0.282|TWO_SIDED|95.0|-0.018|0.063|||ANCOVA|||||0.063|-0.018|0.282
71138670|NCT00387881|141777255|SUPERIORITY_OR_OTHER||Percent difference|18.0|||<|0.001||95.0|10.0|25.0||Endpoints were co-primary and both needed to have p-value of \<0.05 to be considered indicative of efficacy.|Cochran-Mantel-Haenszel||Analysis for Migraine Pain-Free at 2 hours Post-Dose|Pain-Free (2 hours)||25|10|<0.001
71138671|NCT00387881|141777255|SUPERIORITY_OR_OTHER||Percent difference|15.0|||<|0.001||95.0|8.0|22.0|||Cochran-Mantel-Haenszel||Analysis for Sustained Pain Free from 2-24 hours Post-dose|Sustained Pain-Free (2-24 hours)||22|8|<0.001
71138672|NCT00453154|141777265|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using a 1-sided significance level of 0.15, the study has approximately 89% power to reject the null hypothesis|Hazard Ratio (HR)|1.62||||0.02|TWO_SIDED|70.0|1.27|2.08||All randomization was done using a permuted-block scheme with a block size of 6, stratified by combination chemotherapy (cisplatin vs carboplatin) and number of combination chemotherapy cycles (\< 6 vs 6 cycles)|Log Rank|||||2.08|1.27|0.02
71138673|NCT01790594|141777270|SUPERIORITY||Mean Difference (Final Values)|2.088||||0.75|TWO_SIDED|95.0|-11.067|15.242|||Mixed Models Analysis|||The p-value compares Investigational arm and control arm.||15.242|-11.067|0.750
71138674|NCT02152631|141777308|SUPERIORITY||Hazard Ratio (HR)|0.968||||0.771|TWO_SIDED|95.0|0.768|1.219|||Stratified Log-Rank||Hazard Ratio (HR) was estimated based on Stratified Cox proportional hazard model.|The stratification factors used in the analysis were: number of prior chemotherapy regimens (1 versus 2), Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) (0 versus 1), gender (male versus female), and kirsten rat sarcoma (KRAS) mutation (GLY12CYS \[G12C\] vs. all others)||1.219|0.768|0.771
71138675|NCT02152631|141777309|SUPERIORITY|||||||0.01|||||||Cochran-Mantel-Haenszel|||Stratified by number of prior chemotherapy regimens (1 versus 2), ECOG PS (0 versus 1), gender (male versus female), and KRAS mutation (GLY12CYS \[G12C\] vs. all others)||||0.010
71138676|NCT02152631|141777310|SUPERIORITY||Hazard Ratio (HR)|0.583|||<|1e-06|TWO_SIDED|95.0|0.47|0.723|||Stratified Log-Rank|||||0.723|0.470|<0.000001
71138677|NCT02152631|141777311|SUPERIORITY||LS Mean Change Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.19||0.698|TWO_SIDED|95.0|-0.44|0.29|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Headache||0.29|-0.44|0.698
71138678|NCT02152631|141777311|SUPERIORITY||LS Mean Change Difference|0.59|STANDARD_ERROR_OF_MEAN|0.28||0.038|TWO_SIDED|95.0|0.03|1.15|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Diarrhea||1.15|0.03|0.038
71138679|NCT02152631|141777311|SUPERIORITY||LS Mean Change Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.94|-1.86|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Rash||-1.86|-2.94|<.001
70864359|NCT02963935|141214293|SUPERIORITY||Odds Ratio (OR)|1.78||||0.0469|TWO_SIDED|95.0|1.01|3.14|||Regression, Logistic||Liraglutide 3.0 mg/Placebo|Treatment policy estimand. Week 56 responses were analysed using a logistic regression model with treatment, BMI groups, and sex as factors and baseline body weight as covariate. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x10000) imputation approach.||3.14|1.01|0.0469
71138680|NCT02152631|141777311|SUPERIORITY||LS Mean Change Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.16||0.142|TWO_SIDED|95.0|-0.56|0.08|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Mean Core Symptom Severity||0.08|-0.56|0.142
71138681|NCT02152631|141777311|SUPERIORITY||LS Mean Change Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.23||0.514|TWO_SIDED|95.0|-0.59|0.3|||Mixed Models Analysis|Analyzed by Type 3 sums of square, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Mean Interference||0.30|-0.59|0.514
71138682|NCT02152631|141777311|SUPERIORITY||LS Mean Change Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.15||0.646|TWO_SIDED|95.0|-0.37|0.23|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Mean Lung Cancer||0.23|-0.37|0.646
70872186|NCT02495168|141229591|SUPERIORITY||LS Mean Difference|0.159|||<|0.0001|TWO_SIDED|95.0|0.093|0.226||Threshold for significance at 0.05 level.|ANCOVA|||LS means difference and p-value from ANCOVA model with treatment and site as fixed effects, baseline FEV1 as covariate and endpoint as outcome on generic budesonide/formoterol fumarate dihydrate and Placebo participants only.||0.226|0.093|<0.0001
71138683|NCT02152631|141777311|SUPERIORITY||LS Mean Change Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.188|TWO_SIDED|95.0|-0.51|0.1|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Mean Core Plus Lung Cancer||0.10|-0.51|0.188
71138684|NCT02152631|141777313|SUPERIORITY||LS Mean Change Difference|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.951|TWO_SIDED|95.0|-0.05|0.05|||Mixed Models Analysis|Analyzed By Type 3 sums of squares, Change from Baseline = Treatment + Visit + Treatment\*Visit + Baseline.||||0.05|-0.05|0.951
71138685|NCT03776747|141777326|OTHER|Analysis of variance between lung inflation levels|||||<|0.001|||||||ANOVA|||We hypothesized that the anisotropic deformation index (ADC) is dependent upon lung inflation level. (Thus, it is important to standardize lung inflation when using this method)||||<0.001
71138686|NCT02210000|141777331|SUPERIORITY||Median Difference (Net)|-0.212||||0.017|TWO_SIDED|95.0|-0.3716|-0.0448||Posterior probability of the treatment difference in response rate at Week 12 being greater than 0%.|Bayesian method|||||-0.0448|-0.3716|0.017
70864360|NCT02963935|141214293|OTHER||Odds Ratio (OR)|2.14||||0.0063|TWO_SIDED|95.0|1.24|3.69|||Mixed models repeated measurement (MMRM)||Liraglutide 3.0 mg/placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline body weight as covariate, all nested within visit. The MMRM was used to classify responders and analysed with a logistic regression with treatment as the only factor.||3.69|1.24|0.0063
70864361|NCT02963935|141214294|SUPERIORITY||Odds Ratio (OR)|2.26||||0.0311|TWO_SIDED|95.0|1.08|4.74|||Regression, Logistic||Liraglutide 3.0 mg/Placebo|Treatment policy estimand. Week 56 responses were analysed using a logistic regression model with treatment, BMI groups, and sex as factors and baseline body weight as covariate. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach.||4.74|1.08|0.0311
70864362|NCT02963935|141214294|OTHER||Odds Ratio (OR)|2.74||||0.006|TWO_SIDED|95.0|1.33|5.62|||Mixed models repeated measurement (MMRM)||Liraglutide 3.0 mg/placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline body weight as covariate, all nested within visit. The MMRM was used to classify responders and analysed with a logistic regression with treatment as the only factor.||5.62|1.33|0.0060
70864363|NCT02963935|141214295|SUPERIORITY||Odds Ratio (OR)|3.32|||<|0.0001|TWO_SIDED|95.0|1.93|5.72|||Regression, Logistic||Liraglutide 3.0 mg/placebo|"Treatment policy estimand. Week 16 responders were analysed using a logistic regression model with treatment, BMI groups, and sex as factors and baseline body weight as covariate.~Missing values are considered as non-responders."||5.72|1.93|<0.0001
70864364|NCT02963935|141214296|SUPERIORITY||treatment difference|-2.72||||0.0063|TWO_SIDED|95.0|-4.68|-0.77|||ANCOVA||Liraglutide 3.0 mg - placebo|Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate.||-0.77|-4.68|0.0063
70864365|NCT02963935|141214296|OTHER||Treatment difference|-3.45||||0.002|TWO_SIDED|95.0|-5.62|-1.28|||Mixed model repeated measurements (MMRM)||Liraglutide 3.0 mg - placebo|Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate, all nested within visit.||-1.28|-5.62|0.0020
70864366|NCT02963935|141214297|SUPERIORITY||Treatment difference|0.16||||0.8137|TWO_SIDED|95.0|-1.19|1.52|||ANCOVA||Liraglutide 3.0 mg - placebo|Treatment policy estimand. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate.||1.52|-1.19|0.8137
70864367|NCT02963935|141214297|OTHER||Treatment difference|0.16||||0.8053|TWO_SIDED|95.0|-1.12|1.43|||Mixed model repeated measurements (MMRM)||Liraglutide 3.0 mg- placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate, all nested within visit.||1.43|-1.12|0.8053
70864368|NCT02963935|141214298|SUPERIORITY|Superiority was not tested as part of confirmatory testing strategy.|Treatment difference|0.87||||0.6916|TWO_SIDED|95.0|-3.41|5.14|||ANCOVA||Liraglutide 3.0 mg - placebo|Treatment policy estimand. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate.||5.14|-3.41|0.6916
70864369|NCT02963935|141214298|OTHER||treatment difference|1.25||||0.5572|TWO_SIDED|95.0|-2.95|5.45|||Mixed models repeated measurements (MMRM||Liraglutide 3.0 mg - placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate, all nested within visit.||5.45|-2.95|0.5572
71138687|NCT02210000|141777332|SUPERIORITY||Mean Difference (Net)|0.21|||||TWO_SIDED|95.0|-0.2353|0.6553|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Nausea at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.6553|-0.2353|
70864370|NCT02963935|141214299|SUPERIORITY|Superiority was not tested as part of confirmatory testing strategy.|Treatment difference|3.12||||0.6986|TWO_SIDED|95.0|-12.68|18.92|||ANCOVA||Liraglutide 3.0 mg - placebo|Treatment policy estimand. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate.||18.92|-12.68|0.6986
70864371|NCT02963935|141214299|OTHER||Treatment difference|7.66||||0.37|TWO_SIDED|95.0|-9.15|24.48|||Mixed model repeated measurements (MMRM)||Liraglutide 3.0 mg - placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate, all nested within visit.||24.48|-9.15|0.3700
70864372|NCT00464269|141214342|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The overall significance level was controlled at 5 %. The 3 doses of Brivaracetam were tested at the 5 % level against Placebo starting from the 50 mg dose then the 20 mg dose and finally the 5 mg dose, only moving to the next test if the previous one is significant at the 5 % level.|% reduction over Placebo|12.8|||=|0.025|TWO_SIDED|95.0|1.7|22.6|||ANCOVA|Baseline and Treatment Period Partial Onset Seizure (POS) frequencies are standardized to a 7-day duration.|The log-transformed (log(x+1)) POS seizure frequency was analyzed using an ANCOVA model, including terms for treatment, stratification factors, and log-transformed Baseline POS seizure frequency per week as a covariate.|The treatment difference between each Brivaracetam (BRV) dose and Placebo (PBO) is reported as a percent reduction over Placebo. The treatment effect was estimated using the 95 % confidence intervals.||22.6|1.7|=0.025
71138688|NCT02210000|141777332|SUPERIORITY||Mean Difference (Net)|0.749|||||TWO_SIDED|95.0|0.2275|1.2705|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Feeling full after meals at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||1.2705|0.2275|
70864373|NCT00464269|141214342|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The overall significance level was controlled at 5 %. The 3 doses of Brivaracetam were tested at the 5 % level against Placebo starting from the 50 mg dose then the 20 mg dose and finally the 5 mg dose, only moving to the next test if the previous one is significant at the 5 % level.|% reduction over Placebo|4.1|||=|0.492|TWO_SIDED|95.0|-8.1|15.0|||ANCOVA|Baseline and Treatment Period Partial Onset Seizure (POS) frequencies are standardized to 7-day duration.|The log-transformed (log(x+1)) POS seizure frequency was analyzed using an ANCOVA model, including terms for treatment, stratification factors, and log-transformed Baseline POS seizure frequency per week as a covariate.|The treatment difference between each Brivaracetam dose an Placebo is reported as a percent reduction over Placebo. The treatment effect was estimated using 95 % confidence intervals.||15.0|-8.1|=0.492
70864374|NCT02337738|141214365|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84||||0.0006|TWO_SIDED|95.0|-1.32|-0.364|||ANCOVA||Estimated Value was reported for the difference between TVP-1012 1mg and Placebo (TVP-1012 1mg - Placebo).|||-0.364|-1.320|0.0006
70864375|NCT02337738|141214365|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.014|TWO_SIDED|95.0|-1.07|-0.122|||ANCOVA||Estimated Value was reported for the difference between TVP-1012 0.5mg and Placebo (TVP-1012 0.5mg - Placebo).|||-0.122|-1.070|0.0140
70864376|NCT00406354|141214376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.0|-1.5||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-1.5|-5.0|<.001
70864377|NCT00406354|141214377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.4|STANDARD_ERROR_OF_MEAN|1.8|<|0.001|TWO_SIDED|95.0|-11.0|-3.8||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-3.8|-11.0|<.001
70864378|NCT00406354|141214378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.3|-1.8||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-1.8|-5.3|<.001
70864379|NCT00406354|141214379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|1.0|<|0.001|TWO_SIDED|95.0|-5.8|-2.0||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-2.0|-5.8|<.001
70864380|NCT00406354|141214380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.2||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.2|-0.6|<.001
70864381|NCT00406354|141214381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.006|TWO_SIDED|95.0|-0.4|-0.1||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.1|-0.4|0.006
70864382|NCT00406354|141214382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|1.4||0.01|TWO_SIDED|95.0|-6.2|-0.9||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.9|-6.2|0.010
71138689|NCT02210000|141777332|SUPERIORITY||Mean Difference (Net)|0.489|||||TWO_SIDED|95.0|-0.0592|1.0374|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Bloating at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||1.0374|-0.0592|
70864383|NCT00406354|141214383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.7||0.01|TWO_SIDED|95.0|-3.2|-0.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.4|-3.2|0.010
70864384|NCT00406354|141214384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.7||0.406|TWO_SIDED|95.0|-4.9|2.0||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Negative values are in favor of the atomoxetine arms.|||2.0|-4.9|0.406
70864385|NCT00406354|141214385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.1|-0.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.4|-1.1|<.001
70864386|NCT00406354|141214386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.1|-0.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.4|-1.1|<.001
70864387|NCT00406354|141214387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.1|-0.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.4|-1.1|<.001
70864388|NCT00406354|141214388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|2.2||0.021|TWO_SIDED|95.0|0.8|9.3||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.|||9.3|0.8|0.021
70864389|NCT00406354|141214389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.6|STANDARD_ERROR_OF_MEAN|3.1||0.017|TWO_SIDED|95.0|-13.8|-1.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.|||-1.4|-13.8|0.017
71138690|NCT02210000|141777332|SUPERIORITY||Mean Difference (Net)|0.497|||||TWO_SIDED|95.0|0.0396|0.955|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Not able to finish meal at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.9550|0.0396|
71138691|NCT02210000|141777332|SUPERIORITY||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-0.3386|0.4395|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Retching at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.4395|-0.3386|
71138692|NCT02210000|141777332|SUPERIORITY||Mean Difference (Net)|-0.038|||||TWO_SIDED|95.0|-0.3242|0.2492|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Vomiting at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.2492|-0.3242|
71138693|NCT02210000|141777332|SUPERIORITY||Mean Difference (Net)|0.475|||||TWO_SIDED|95.0|-0.0483|0.9978|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Stomach visibly larger at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.9978|-0.0483|
70864390|NCT00406354|141214390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5|STANDARD_ERROR_OF_MEAN|2.8||0.05|TWO_SIDED|95.0|0.0|10.9||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.|||10.9|-0.0|0.050
70864391|NCT00406354|141214391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.7|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|4.9|16.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.|||16.4|4.9|<.001
70864392|NCT00406354|141214392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.1|STANDARD_ERROR_OF_MEAN|3.3||0.015|TWO_SIDED|95.0|1.6|14.6||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.|||14.6|1.6|0.015
70864393|NCT00406354|141214393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|3.4||0.018|TWO_SIDED|95.0|1.4|14.7||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive results are in favor of the atomoxetine arms.|||14.7|1.4|0.018
70864394|NCT00406354|141214394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9|STANDARD_ERROR_OF_MEAN|3.3||0.138|TWO_SIDED|95.0|-1.6|11.5||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.|||11.5|-1.6|0.138
70864395|NCT00406354|141214395|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.193||||0.016||95.0|1.16|4.146||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Log Rank|||||4.146|1.160|0.016
70864396|NCT00406354|141214396|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||p-value is from comparison of atomoxetine fast group versus atomoxetine slow group for any clinically relevant categories of adverse events during the initial three weeks of study treatment|Fisher Exact|||||||0.102
70864397|NCT00406354|141214397|SUPERIORITY_OR_OTHER|||||||0.101||95.0||||p-value is from comparison of atomoxetine fast group versus atomoxetine slow group for any clinically relevant categories of adverse events during the nine-week study treatment period.|Fisher Exact|||||||0.101
70864398|NCT01498978|141214419|OTHER|Exact binomial test (two-sided).||||||0.754|||||||Exact Binomial Test|||Exact binomial test (two-sided). Null hypothesis: the proportion is equal to 0.5||||0.754
70864399|NCT01498978|141214420|OTHER|Test of association (contingency) between the two kinds of classification.||||||0.19|||||||Fisher Exact|||||||0.190
70948073|NCT00267098|141396988|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|0.016|||||TWO_SIDED|95.0|-2.379|2.425||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in MR through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean MR change through 18 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Mitral Regurgitation (MR) through 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Mitral Regurgitation through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value.||2.425|-2.379|
70864400|NCT01498978|141214423|OTHER|Test of association (contingency) between the two kinds of classification.||||||0.5|||||||Fisher Exact|||||||0.500
70864401|NCT01498978|141214424|OTHER|Test of association (contingency) between the two kinds of classification.||||||1|||||||Fisher Exact|||||||1.000
70864402|NCT01498978|141214425|OTHER|Test of association (contingency) between the two kinds of classification.||||||0.524|||||||Fisher Exact|||||||0.524
70864403|NCT01033851|141214448|SUPERIORITY_OR_OTHER|||||||0.0366||95.0|||||ANOVA|||A repeated measure ANOVA, with time as the repeated measure, treatment arm as between-subjects factor and CGI-S score as the dependent variable, found a main effect of time (F(1,84)=62.19, p\<0.001) and a significant treatment arm X time interaction (F(1,84)=4.51, p=0.0366).||||0.0366
70864404|NCT01011738|141214453|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.349||||0.0022|TWO_SIDED|95.0|1.542|7.271||Multiple logistic regression were run in stepwise procedure with significance level of 0.05 to stay, considering all pre and on-treatment factors identified by univariate logistic regression to be associated with HBsAg clearance 3 yrs post-treatment.|Wald-Chi-Square test|||In HBeAg positive participants, Log10-drop HBsAg at Week 24 was analyzed as the predictor factor of HBsAg clearance at 3 years post-treatment in analysis A.||7.271|1.542|0.0022
70864405|NCT01011738|141214453|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.595||||0.0019|TWO_SIDED|95.0|1.603|8.063||Multiple logistic regression were run in stepwise procedure with significance level of 0.05 to stay, considering all pre and on-treatment factors identified by univariate logistic regression to be associated with HBsAg clearance 3 yrs post-treatment.|Wald-Chi-Square test|||In HBeAg positive participants, Log10-drop HBsAg at Week 24 was analyzed as the predictor factor of HBsAg clearance at 3 years post-treatment in analysis B.||8.063|1.603|0.0019
70864406|NCT01011738|141214453|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.851||||0.0369|TWO_SIDED|95.0|0.732|0.99||Multiple logistic regression were run in stepwise procedure with significance level of 0.05 to stay, considering all pre and on-treatment factors identified by univariate logistic regression to be associated with HBsAg clearance 3 yrs post-treatment.|Wald-Chi-Square test|||In HBeAg positive participants, Weight in kg was analyzed as independent predictor factor of HBsAg clearance at 3 years post-treatment in analysis A.||0.990|0.732|0.0369
70864407|NCT01011738|141214457|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.155||||0.0033|TWO_SIDED|95.0|0.045|0.539||Multiple logistic regression were run in stepwise procedure with significance level of 0.05 to stay, considering all pre and on-treatment factors identified by univariate logistic regression to be associated with HBsAg clearance 3 yrs post-treatment.|Wald-Chi-Square test|||In HBeAg negative participants, HBsAg in log10 IU/mL at Week 24 was analyzed as the predictor factor of HBsAg clearance at 3 years post-treatment in analysis A.||0.539|0.045|0.0033
70864408|NCT01011738|141214457|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.191||||0.0042|TWO_SIDED|95.0|0.062|0.594|||Wald-Chi-Square test|||In HBeAg negative participants, HBsAg in log10 IU/mL at Week 24 was analyzed as the predictor factor of HBsAg clearance at 3 years post-treatment in analysis B.||0.594|0.062|0.0042
70872187|NCT02495168|141229591|SUPERIORITY||LS Mean Difference|0.164|||<|0.0001|TWO_SIDED|95.0|0.099|0.229||Threshold for significance at 0.05 level.|ANCOVA|||LS means difference and p-value from ANCOVA model with treatment and site as fixed effects, baseline FEV1 as covariate and endpoint as outcome on Symbicort and Placebo participants only.||0.229|0.099|<0.0001
70872188|NCT02270957|141229604|SUPERIORITY||||||>|0.999|||||||Chi-squared|||||||>0.999
70864409|NCT01011738|141214457|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.528||||0.0149|TWO_SIDED|95.0|1.086|2.15||Multiple logistic regression were run in stepwise procedure with significance level of 0.05 to stay, considering all pre and on-treatment factors identified by univariate logistic regression to be associated with HBsAg clearance 3 yrs post-treatment.|Wald-Chi-Square test|||In HBeAg negative participants, ALT ratio was analysed as the predictor factor of HBsAg clearance at 3 years post-treatment in analysis A.||2.150|1.086|0.0149
70864410|NCT01163266|141214472|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.19|STANDARD_ERROR_OF_MEAN|1.151||0.058|TWO_SIDED|95.0|-4.45|0.08||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||All statistical tests were 2-sided with the estimated P-values at the 5% level of significance. To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 20 mg vortioxetine to placebo. Efficacy endpoints were tested for each dose in sequential order at significance level 0.025; as soon as an endpoint was non-significant at 0.025, the testing procedure stopped for all subsequent endpoints.||0.08|-4.45|0.058
70864411|NCT01163266|141214472|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.64|STANDARD_ERROR_OF_MEAN|1.161||0.002|TWO_SIDED|95.0|-5.92|-1.35||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.025, hierarchical testing continues.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||-1.35|-5.92|0.002
70864412|NCT01163266|141214473|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.301|TWO_SIDED|95.0|0.796|2.093|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||2.093|0.796|0.301
70864413|NCT01163266|141214473|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.639||||0.044|TWO_SIDED|95.0|1.013|2.652||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||2.652|1.013|0.044
70864414|NCT01163266|141214474|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.129||0.119|TWO_SIDED|95.0|-0.45|0.05|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||0.05|-0.45|0.119
70864415|NCT01163266|141214474|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.129||0.024|TWO_SIDED|95.0|-0.55|-0.04|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||-0.04|-0.55|0.024
70864416|NCT01163266|141214475|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.29|STANDARD_ERROR_OF_MEAN|1.891||0.025|TWO_SIDED|95.0|-8.03|-0.56|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS Total score-by-week as fixed effects.||||-0.56|-8.03|0.025
70864417|NCT01163266|141214475|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.26|STANDARD_ERROR_OF_MEAN|1.852|<|0.001|TWO_SIDED|95.0|-10.92|-3.6|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||-3.60|-10.92|<0.001
70864418|NCT01163266|141214476|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.665||||0.093|TWO_SIDED|95.0|0.918|3.018|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||3.018|0.918|0.093
70948074|NCT00267098|141396989|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.653|||||TWO_SIDED|95.0|-3.337|2.046||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in MR through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean MR change through 24 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Mitral Regurgitation (MR) through 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Mitral Regurgitation through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value.||2.046|-3.337|
70864419|NCT01163266|141214476|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.779||||0.059|TWO_SIDED|95.0|0.979|3.233|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||3.233|0.979|0.059
70864420|NCT01163266|141214477|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|1.042||0.183|TWO_SIDED|95.0|-3.44|0.66|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||0.66|-3.44|0.183
70864421|NCT01163266|141214477|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.066||0.025|TWO_SIDED|95.0|-4.5|-0.3|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||-0.30|-4.50|0.025
70864422|NCT02586064|141214478|OTHER|||||||0.28|||||||t-test, 1 sided|||Baseline||||0.28
70864423|NCT02586064|141214478|EQUIVALENCE|Confidence interval 95%, equivalence margin \[-7,7\].|Mean Difference (Final Values)|1.52|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|||||||||||||
70864424|NCT02586064|141214478|OTHER|||||||0.87|||||||t-test, 1 sided|||End of Treatment||||0.87
70864425|NCT02586064|141214478|EQUIVALENCE|Confidence interval 95%, equivalence margin \[-7,7\].|Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|2.57|||TWO_SIDED|||||||||||||
70864426|NCT02586064|141214478|EQUIVALENCE|Equivalence hypothesis was assessed using the confidence intervals for the mean differences compared to margins of equivalence (-7,7). The equivalence hypothesis was examined based on the difference between the amount of change from the baseline to the end of treatment on the CAPS between the two conditions. Confidence interval is -7.0 to 1.9.||||||0.26|||||||t-test, 2 sided|||Change||||0.26
70864427|NCT02586064|141214478|EQUIVALENCE|Confidence interval 95%, equivalence margin \[-7,7\].|Mean Difference (Final Values)|-2.56|STANDARD_ERROR_OF_MEAN|2.25|||TWO_SIDED|||||||||||||
70864428|NCT02586064|141214478|OTHER|||||||0.68|||||||t-test, 1 sided|||3 Month Post Treatment||||0.68
71138694|NCT02210000|141777332|SUPERIORITY||Mean Difference (Net)|0.461|||||TWO_SIDED|95.0|-0.0519|0.9748|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Stomach fullness at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.9748|-0.0519|
71138695|NCT02210000|141777332|SUPERIORITY||Mean Difference (Net)|0.536|||||TWO_SIDED|95.0|0.0967|0.9745|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Loss of appetite at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.9745|0.0967|
71138696|NCT02210000|141777332|SUPERIORITY||Mean Difference (Net)|0.196|||||TWO_SIDED|95.0|-0.2746|0.6671|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Upper abdominal pain at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.6671|-0.2746|
71138697|NCT02210000|141777332|SUPERIORITY||Mean Difference (Net)|0.314|||||TWO_SIDED|95.0|-0.2013|0.8292|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Upper abdominal discomfort at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.8292|-0.2013|
71138698|NCT02210000|141777332|SUPERIORITY||Mean Difference (Net)|0.384|||||TWO_SIDED|95.0|-0.0323|0.7997|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Overall severity of your GP symptoms at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.7997|-0.0323|
71138699|NCT02210000|141777332|SUPERIORITY||Mean Difference (Net)|0.068|||||TWO_SIDED|95.0|-0.2366|0.3723|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Nausea/Vomiting Subscale at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.3723|-0.2366|
71138700|NCT02210000|141777332|SUPERIORITY||Mean Difference (Net)|0.548|||||TWO_SIDED|95.0|0.1333|0.9628|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Fullness/Early Satiety Subscale at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.9628|0.1333|
71138701|NCT02210000|141777332|SUPERIORITY||Mean Difference (Net)|0.479|||||TWO_SIDED|95.0|-0.0386|0.9966|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Bloating Subscale at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.9966|-0.0386|
71138702|NCT02210000|141777332|SUPERIORITY||Mean Difference (Net)|0.356|||||TWO_SIDED|95.0|-0.0049|0.7179|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Total GCSI-DD at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.7179|-0.0049|
71138703|NCT00308139|141777359|NON_INFERIORITY_OR_EQUIVALENCE|The choice of a 0.4% noninferiority margin was resulted from the considerations of expected clinical benefit of BYETTA in this study based on clinical data evaluating exenatide LAR and BYETTA, regulatory guidance, published literature, and statistical considerations.|Least Squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.107||0.0023|TWO_SIDED|95.0|-0.54|-0.12|||ANOVA|Analysis of variance (ANOVA) model includes treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors.||Superiority of exenatide long-acting release (LAR) once weekly to BYETTA if the upper limit of the 2-sided 95% confidence interval (CI) for treatment difference (LAR minus BYETTA) is less than 0; non-inferiority if this upper limit is less than 0.4%. Power:Assuming 20% dropout rate with 246 subjects will complete the study. This sample size would provide 90% power for non-inferiority test with assumption of greater reduction (0.1%) in LAR and a common standard deviation of 1.2%.||-0.12|-0.54|0.0023
71138704|NCT00308139|141777362|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target value of \<7% at Week 30 were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which baseline HbA1c stratum (\<9% or \>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.||||0.0003
71138705|NCT00308139|141777364|SUPERIORITY_OR_OTHER|||||||0.2042|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Analysis: Percentage of subjects achieving HbA1c target value of \<=6.5% at Week 30 were compared between treatments using CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.||||0.2042
71138706|NCT00308139|141777366|SUPERIORITY_OR_OTHER|||||||0.1513|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target values of \<=6.0% at Week 30 were compared between treatments using CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.||||0.1513
70864429|NCT02586064|141214478|EQUIVALENCE|Confidence interval 95%, equivalence margin \[-7,7\].|Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|3.16|||TWO_SIDED|||||||||||||
70864430|NCT02586064|141214478|OTHER|||||||0.84|||||||t-test, 1 sided|||6 Month Follow Up||||0.84
70948075|NCT00267098|141396990|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|0.08|||||TWO_SIDED|95.0|-0.031|0.195||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in CI through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean CI change through 6 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Cardiac Index (CI) through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Cardiac Index through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value.||0.195|-0.031|
71138707|NCT00308139|141777368|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|30.08|STANDARD_ERROR_OF_MEAN|11.458||0.0124|TWO_SIDED|95.0|6.88|53.28|||ANCOVA|||Analysis: Change in 2h postprandial glucose from baseline (Day -3) to Week 14 was analyzed using an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the 2h postprandial glucose as a covariate. Null hypothesis: no difference between treatments in change from baseline 2h postprandial glucose.||53.28|6.88|0.0124
71138708|NCT00308139|141777370|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.612||0.8916|TWO_SIDED|95.0|-1.29|1.12|||ANCOVA|||Analysis: Change in body weight from baseline (Day -3) to Week 30 was analyzed using an analysis of covariance (ANCOVA) model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the body weight as a covariate. Null hypothesis: no difference between treatments in change from baseline body weight. Power: based on the primary measurement.||1.12|-1.29|0.8916
71138709|NCT00308139|141777372|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-16.9|STANDARD_ERROR_OF_MEAN|3.8|<|0.0001|TWO_SIDED|95.0|-24.4|-9.4|||ANCOVA|||Analysis: Change in fasting plasma glucose from baseline (Day -3) to Week 30 was analyzed using an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the fasting plasma glucose as a covariate. Null hypothesis: no difference between treatments in change from baseline fasting plasma glucose. Power: based on the primary measurement.||-9.4|-24.4|<.0001
71138710|NCT00308139|141777376|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-8.2|STANDARD_ERROR_OF_MEAN|3.04||0.0077|TWO_SIDED|95.0|-14.1|-2.2|||ANCOVA|||Analysis: Change in total cholesterol from baseline (Day -3) to Week 30 was analyzed using an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the total cholesterol as a covariate. Null hypothesis: no difference between treatments in change from baseline total cholesterol. Power: based on the primary measurement.||-2.2|-14.1|0.0077
71138711|NCT00308139|141777378|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.74||0.5613|TWO_SIDED|95.0|-1.0|1.9|||ANCOVA|||Analysis: Change in HDL-C from baseline (Day -3) to Week 30 was analyzed using an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the HDL as a covariate. Null hypothesis: no difference between treatments in change from baseline HDL. Power: based on the primary measurement.||1.9|-1.0|0.5613
71138712|NCT00308139|141777381|SUPERIORITY_OR_OTHER||Geometic Least Squares Mean Ratio|0.95|STANDARD_ERROR_OF_MEAN|0.042||0.2915|TWO_SIDED|95.0|0.87|1.04|||ANCOVA|||Analysis: Triglycerides data were logarithm-transformed and the change at Week 30 to baseline (Day -3), expressed as the ratio, was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the triglycerides as a covariate. Null hypothesis: no difference between treatments in change from baseline triglycerides. Power: based on the primary measurement.||1.04|0.87|0.2915
71138713|NCT00833040|141777387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.3|STANDARD_ERROR_OF_MEAN|4.49|<|0.001||95.0|||||ANCOVA|||difference between the active and placebo groups||||<0.001
71138714|NCT01755234|141777408|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.97
71138715|NCT01755234|141777409|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.96
71138716|NCT01755234|141777410|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.96
71138717|NCT01755234|141777411|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.84
70872189|NCT02270957|141229605|SUPERIORITY|||||||0.587|||||||Chi-squared|||||||0.587
71138718|NCT02648204|141777414|NON_INFERIORITY|Non-Inferiority margin: 0.4|Treatment difference|-0.4|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.55|-0.25|||Mixed Models Analysis|||||-0.25|-0.55|<0.0001
71138719|NCT02648204|141777414|SUPERIORITY||Treatment difference|-0.4|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.55|-0.25|||Mixed Models Analysis|||||-0.25|-0.55|<0.0001
71138720|NCT02648204|141777414|NON_INFERIORITY|Non-Inferiority margin: 0.04|Treatment difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.57|-0.25|||Mixed Models Analysis|||||-0.25|-0.57|<0.0001
71138721|NCT02648204|141777414|SUPERIORITY||Treatment difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.57|-0.25|||Mixed Models Analysis|||||-0.25|-0.57|<0.0001
71138722|NCT02648204|141777415|SUPERIORITY||Treatment difference|-2.26|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|-3.02|-1.51|||Mixed Models Analysis|||||-1.51|-3.02|<0.0001
71138723|NCT02648204|141777415|SUPERIORITY||Treatment difference|-3.55|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|-4.32|-2.78|||Mixed Models Analysis|||||-2.78|-4.32|<0.0001
71138724|NCT01794000|141777446|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|0.83||||0.117|TWO_SIDED|95.0|0.66|1.05|||Andersen-Gill model||The rate ratio and 2-sided 95% Confidence Interval (CI) were estimated from the Andersen-Gill model.|The time to a recurrent episode of VOC was analyzed using Andersen-Gill model. A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.||1.05|0.66|.117
71138725|NCT01794000|141777447|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.242||||0.912|TWO_SIDED|95.0|-4.564|4.079||Mixed Model Repeated Measures (MMRM) included fixed effects of treatment, baseline value of the pain-diary outcome measure, hydroxyurea use, age group, time and treatment-by-time interaction.|Mixed Models Analysis||The Least Square (LS) Mean difference of prasugrel minus placebo and the corresponding 2-sided 95% CI were estimated from the MMRM model.|||4.079|-4.564|.912
71138726|NCT01794000|141777448|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.0968||||0.365|TWO_SIDED|95.0|-0.1132|0.3068||MMRM model included fixed effects of treatment, baseline value of the pain-diary outcome measure, hydroxyurea use, age group, time and treatment-by-time interaction.|Mixed Models Analysis||The LS Mean difference of prasugrel minus placebo and the corresponding 2-sided 95% CI were estimated from the MMRM model.|||0.3068|-0.1132|.365
71138727|NCT01794000|141777449|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|0.82||||0.109|TWO_SIDED|95.0|0.65|1.04||The time to a recurrent episode of painful crisis was analyzed using Andersen-Gill model.|Andersen-Gill Model|A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.|The rate ratio and 2-sided 95% CI were estimated from the Andersen-Gill model.|||1.04|0.65|.109
71138728|NCT01794000|141777450|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|0.94||||0.759|TWO_SIDED|95.0|0.65|1.37||The time to a recurrent episode of hospitalization was analyzed using Andersen-Gill model.|Andersen-Gill model|A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.|The rate ratio and 2-sided 95% CI were estimated from the Andersen-Gill model.|||1.37|0.65|.759
71138729|NCT01794000|141777451|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|0.96||||0.916|TWO_SIDED|95.0|0.48|1.93||The time to a recurrent episode of acute chest syndrome was analyzed using Andersen-Gill model.|Andersen-Gill model|A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.|The rate ratio and 2-sided 95% CI were estimated from the Andersen-Gill model.|||1.93|0.48|.916
71138730|NCT01794000|141777452|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|1.17||||0.544|TWO_SIDED|95.0|0.71|1.91||The time to a recurrent episode of RBC transfusion was analyzed using Andersen-Gill model.|Andersen-Gill model|A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.|The rate ratio and 2-sided 95% CI were estimated from the Andersen-Gill model.|||1.91|0.71|.544
71138731|NCT01794000|141777453|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.513||||0.602|TWO_SIDED|95.0|-4.186|7.213||The MMRM model included the fixed effects of treatment, the baseline value of the pain-diary measure, hydroxyurea use, age group, time and treatment-by-time interaction.|Mixed Models Analysis||The Least Square Mean difference of prasugrel minus placebo and the corresponding 2-sided 95% CI were estimated from the MMRM model.|||7.213|-4.186|.602
71138732|NCT01794000|141777454|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.272||||0.459|TWO_SIDED|95.0|-2.109|4.652||The MMRM model included the fixed effects of treatment, the baseline value of the pain-diary measure, hydroxyurea use, age group, time and treatment-by-time interaction.|Mixed Models Analysis||The LS Mean difference of prasugrel minus placebo and the corresponding 2-sided 95% CI were estimated from the MMRM model.|||4.652|-2.109|.459
71138733|NCT01794000|141777456|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.94||||0.662|TWO_SIDED|95.0|-3.31|5.19||The ANCOVA model included the factors of treatment, hydroxyurea use, age group, and length of follow-up.|ANCOVA||The LS Mean difference of prasugrel minus placebo and 2-sided 95% CI were estimated from the ANCOVA model.|||5.19|-3.31|.662
71138734|NCT01794000|141777457|SUPERIORITY_OR_OTHER_LEGACY|||||||0.317|||||||Log Rank|A stratified log-rank test were performed with hydroxyurea use and age group as the stratification factors.||Time from Randomization to the First VOC||||.317
71138735|NCT01794000|141777457|SUPERIORITY_OR_OTHER_LEGACY|||||||0.133|||||||Log Rank|A stratified log-rank test were performed with hydroxyurea use and age group as the stratification factors.||Time from Randomization to the Second VOC||||.133
71138736|NCT01794000|141777458|SUPERIORITY_OR_OTHER_LEGACY|||||||0.638|||||||Fisher Exact|||||||.638
71138737|NCT02748863|141777459|SUPERIORITY||Odds Ratio (OR)|717.42|||<|0.0001|TWO_SIDED|95.0|68.0|7569.56|||Regression, Logistic|||||7569.56|68.00|< 0.0001
71138738|NCT02748863|141777460|SUPERIORITY||Odds Ratio (OR)|168.39|||<|0.0001|TWO_SIDED|95.0|21.2|1337.22|||Regression, Logistic|||||1337.22|21.20|< 0.0001
71138739|NCT02748863|141777461|SUPERIORITY||Risk Difference (RD)|38.75|||<|0.0001|TWO_SIDED|95.0|27.41|50.09|||t-test, 2 sided|||||50.09|27.41|< 0.0001
71138740|NCT02748863|141777461|SUPERIORITY||Risk Difference (RD)|36.48|||<|0.0001|TWO_SIDED|95.0|25.19|47.76|||t-test, 2 sided|||||47.76|25.19|< 0.0001
71138741|NCT02748863|141777463|SUPERIORITY||Odds Ratio (OR)|400.58|||<|0.0001|TWO_SIDED|95.0|47.48|3379.99|||Regression, Logistic|||||3379.99|47.48|< 0.0001
71138742|NCT00657046|141777479|SUPERIORITY_OR_OTHER|||||||0.693|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.693
71138743|NCT00657046|141777479|SUPERIORITY_OR_OTHER|||||||0.807|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.807
71138744|NCT00657046|141777480|SUPERIORITY_OR_OTHER|||||||0.212|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.212
70864431|NCT02586064|141214478|EQUIVALENCE|Confidence interval 95%, equivalence margin \[-7,7\].|Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|3.05|||TWO_SIDED|||||||||||||
70864432|NCT02586064|141214479|OTHER|||||||0.36|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||Baseline||||0.36
70864433|NCT02586064|141214479|OTHER|||||||0.34|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||4-Week||||0.34
70864434|NCT02586064|141214479|OTHER|||||||0.43|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||8-Week||||0.43
70864435|NCT02586064|141214479|OTHER|||||||0.09|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||6 Month Post Treatment||||0.09
70864436|NCT02586064|141214479|OTHER|||||||0.41|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||End of Treatment||||0.41
70864437|NCT02586064|141214479|SUPERIORITY|Superiority hypotheses were assessed using the confidence interval for the mean differences (-0.33 to 0.20) compared to margin of superiority (-.05).||||||0.64|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||Change||||0.64
70864438|NCT02586064|141214479|OTHER|||||||0.22|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||3 Month Post Treatment||||0.22
70864439|NCT02586064|141214480|OTHER|||||||0.4|||||||t-test, 1 sided|||Baseline||||0.40
70864440|NCT02586064|141214480|OTHER|||||||0.65|||||||t-test, 1 sided|||End of Treatment||||0.65
70864441|NCT02586064|141214480|OTHER|||||||0.64|||||||t-test, 1 sided|||Change||||0.64
70864442|NCT02586064|141214480|OTHER|||||||0.64|||||||t-test, 1 sided|||3 Month Post Treatment||||0.64
70864443|NCT02586064|141214480|OTHER|||||||0.76|||||||t-test, 1 sided|||6 Month Post Treatment||||0.76
70864444|NCT02586064|141214481|OTHER|||||||0.11|||||||t-test, 1 sided|||Baseline||||0.11
70864445|NCT02586064|141214481|OTHER|||||||0.48|||||||t-test, 1 sided|||4-Week||||0.48
70864446|NCT02586064|141214481|OTHER|||||||0.74|||||||t-test, 1 sided|||8-Week||||0.74
70864447|NCT02586064|141214481|OTHER|||||||0.34|||||||t-test, 1 sided|||End of Treatment||||0.34
70864448|NCT02586064|141214481|OTHER|||||||0.65|||||||t-test, 1 sided|||Change||||0.65
70864449|NCT02586064|141214481|OTHER|||||||0.14|||||||t-test, 1 sided|||3 Month Post Treatment||||0.14
70864450|NCT02586064|141214481|OTHER|||||||0.18|||||||t-test, 1 sided|||6 Month Post Treatment||||0.18
71138745|NCT00657046|141777480|SUPERIORITY_OR_OTHER|||||||0.23|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.230
71138746|NCT00657046|141777481|SUPERIORITY_OR_OTHER|||||||0.712|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.712
71138747|NCT00657046|141777481|SUPERIORITY_OR_OTHER|||||||0.607|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.607
71138748|NCT00657046|141777482|SUPERIORITY_OR_OTHER|||||||0.4602|||||||ANCOVA|GLM model with baseline as a covariate||||||0.4602
71138749|NCT00657046|141777482|SUPERIORITY_OR_OTHER|||||||0.94|||||||ANCOVA|GLM model with baseline as a covariate||||||0.940
71138750|NCT00657046|141777483|SUPERIORITY_OR_OTHER|||||||0.376|||||||ANCOVA|GLM model with baseline as a covariate||||||0.376
71138751|NCT00657046|141777483|SUPERIORITY_OR_OTHER|||||||0.903|||||||ANCOVA|GLM model with baseline as a covariate||||||0.903
71138752|NCT00657046|141777484|SUPERIORITY_OR_OTHER|||||||0.319|||||||ANCOVA|GLM model with baseline as a covariate||||||0.319
71138753|NCT00657046|141777484|SUPERIORITY_OR_OTHER|||||||0.408|||||||ANCOVA|GLM model with baseline as a covariate||||||0.408
71138754|NCT00657046|141777485|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANCOVA|GLM model with baseline as a covariate||||||0.004
71138755|NCT00657046|141777485|SUPERIORITY_OR_OTHER|||||||0.03|||||||ANCOVA|GLM model with baseline as a covariate||||||0.030
71138756|NCT00657046|141777486|SUPERIORITY_OR_OTHER|||||||0.025|||||||ANCOVA|GLM model with baseline as a covariate||||||0.025
71138757|NCT00657046|141777486|SUPERIORITY_OR_OTHER|||||||0.022|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.022
71138758|NCT00657046|141777487|SUPERIORITY_OR_OTHER|||||||0.082|||||||Fisher Exact|||||||0.082
71138759|NCT00657046|141777487|SUPERIORITY_OR_OTHER|||||||0.008|||||||Fisher Exact|||||||0.008
71138760|NCT00101686|141777501|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.433||||0.0152||95.0|1.09|1.89||p-value corresponds to the log-rank test for comparing Kaplan-Meier survival curves.|Log Rank||Hazard ratio \[mIRI:FOLFIRI\] is from the Cox Proportional Hazard Model using treatment (FOLFIRI, mIRI, CapeIRI), age (\<=70 vs \>70), performance status (0 vs 1), aspirin (Yes vs No), celecoxib (Yes or No) as the covariates.|||1.89|1.09|0.0152
71138761|NCT00101686|141777502|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.512||||0.0042||95.0|1.16|1.97|||Log Rank|||||1.97|1.16|0.0042
71138762|NCT00101686|141777502|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.368||||0.0156||95.0|1.04|1.8|||Log Rank|||||1.80|1.04|0.0156
71138763|NCT00101686|141777502|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.057||||0.4659||95.0|0.81|1.38|||Log Rank|||||1.38|0.81|0.4659
71138764|NCT00101686|141777503|SUPERIORITY_OR_OTHER||F-distribution method|47.2||||||95.0|38.85|55.71|||||Exact confidence interval for binomial proportion using the F-distribution method (unit: %)|||55.71|38.85|
71138765|NCT00101686|141777503|SUPERIORITY_OR_OTHER||F-distribution method|43.3||||||95.0|34.95|51.86|||||Exact confidence interval for binomial proportion using the F-distribution method (unit: %)|||51.86|34.95|
71138766|NCT00101686|141777503|SUPERIORITY_OR_OTHER||F-distribution method|38.6||||||95.0|30.66|47.06|||||Exact confidence interval for binomial proportion using the F-distribution method (unit: %)|||47.06|30.66|
71138767|NCT00101686|141777503|SUPERIORITY_OR_OTHER|||||||0.4751|||||||Cochran-Mantel-Haenszel|||||||0.4751
71138768|NCT00101686|141777503|SUPERIORITY_OR_OTHER|||||||0.1591|||||||Cochran-Mantel-Haenszel|||||||0.1591
71138769|NCT00101686|141777503|SUPERIORITY_OR_OTHER|||||||0.4395|||||||Cochran-Mantel-Haenszel|||||||0.4395
71138770|NCT00101686|141777504|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.268||||0.0879||95.0|0.96|1.68|||Log Rank|||||1.68|0.96|0.0879
71138771|NCT00101686|141777504|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.2765||95.0|0.9|1.58|||Log Rank|||||1.58|0.90|0.2765
71138772|NCT00101686|141777504|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.049||||0.9364||95.0|0.8|1.38|||Log Rank|||||1.38|0.80|0.9364
71138773|NCT00101686|141777506|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.068||||0.7163||95.0|0.86|1.33|||Log Rank|||||1.33|0.86|0.7163
70948076|NCT00267098|141396991|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|0.086|||||TWO_SIDED|95.0|-0.022|0.198||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in CI through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean CI change through 12 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Cardiac Index (CI) through 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Cardiac Index through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value.||0.198|-0.022|
71138774|NCT00101686|141777507|SUPERIORITY_OR_OTHER||F-distribution method|39.4||||||95.0|32.83|46.34|||||confidence interval for binomial proportion using the F-distribution method (unit: %)|||46.34|32.83|
70864451|NCT02586064|141214482|OTHER|||||||0.08|||||||t-test, 1 sided|||Baseline||||0.08
71138775|NCT00101686|141777507|SUPERIORITY_OR_OTHER||F-distribution method|46.5||||||95.0|39.76|53.42|||||confidence interval for binomial proportion using the F-distribution method (unit: %)|||53.42|39.76|
71138776|NCT00101686|141777507|SUPERIORITY_OR_OTHER|||||||0.1559|||||||Cochran-Mantel-Haenszel|||||||0.1559
71138777|NCT00101686|141777508|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.5316||95.0|0.86|1.36|||Log Rank|||||1.36|0.86|0.5316
71138778|NCT00101686|141777509|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.269||||0.2835||95.0|0.75|2.15|||Log Rank|||||2.15|0.75|0.2835
71138779|NCT00101686|141777510|SUPERIORITY_OR_OTHER||F-distribution method|57.9||||||95.0|44.08|70.86|||||Exact confidence interval for binomial proportion using the F-distribution method (unit: %)|||70.86|44.08|
71138780|NCT00101686|141777510|SUPERIORITY_OR_OTHER||F-distribution method|53.3||||||95.0|40.0|66.33|||||Exact confidence interval for binomial proportion using the F-distribution method (unit: %)|||66.33|40.00|
71138781|NCT00101686|141777510|SUPERIORITY_OR_OTHER|||||||0.7388|||||||Cochran-Mantel-Haenszel|||||||0.7388
70864452|NCT02586064|141214482|OTHER|||||||0.07|||||||t-test, 1 sided|||End of Treatment||||0.07
70864453|NCT02586064|141214482|OTHER|||||||0.86|||||||t-test, 1 sided|||Change||||0.86
70864454|NCT02586064|141214482|OTHER|||||||0.003|||||||t-test, 1 sided|||3 Month Post Treatment||||0.003
70864455|NCT02586064|141214482|OTHER|||||||0.03|||||||t-test, 1 sided|||6 Month Post Treatment||||0.03
71138782|NCT00101686|141777512|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.794||||0.037||95.0|1.12|2.88|||Log Rank|||||2.88|1.12|0.0370
71138783|NCT00867165|141777515|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-26.74|||<|0.001|TWO_SIDED|95.0|-30.8|-22.69|||ANCOVA|||||-22.69|-30.80|<0.001
71138784|NCT00867165|141777516|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-20.92|||<|0.001|TWO_SIDED|95.0|-24.2|-17.65|||ANCOVA|||||-17.65|-24.20|<0.001
71138785|NCT00867165|141777517|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-20.24|||<|0.001|TWO_SIDED|95.0|-24.02|-16.45|||ANCOVA|||||-16.45|-24.02|<0.001
71138786|NCT00867165|141777518|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.7||||0.807|TWO_SIDED|95.0|-4.97|6.36|||ANCOVA|||||6.36|-4.97|0.807
71138787|NCT00867165|141777519|SUPERIORITY_OR_OTHER_LEGACY||Differrence in least-squares means|-25.75|||<|0.001|TWO_SIDED|95.0|-29.59|-21.91|||ANCOVA|||||-21.91|-29.59|<0.001
71138788|NCT00867165|141777520|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-14.68||||0.021|TWO_SIDED|95.0|-27.35|-2.0|||Constrained longitudinal data analysis|||||-2.00|-27.35|0.021
71138789|NCT00867165|141777521|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-24.97|||<|0.001|TWO_SIDED|95.0|-28.95|-20.99|||ANCOVA|||||-20.99|-28.95|<0.001
71138790|NCT00867165|141777522|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-23.94|||<|0.001|TWO_SIDED|95.0|-27.49|-20.39|||ANCOVA|||||-20.39|-27.49|<0.001
71138791|NCT00867165|141777523|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-27.71|||<|0.001|TWO_SIDED|95.0|-31.7|-23.73|||ANCOVA|||||-23.73|-31.70|<0.001
71138792|NCT00867165|141777524|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-20.09|||<|0.001|TWO_SIDED|95.0|-23.3|-16.89|||ANCOVA|||||-16.89|-23.30|<0.001
71138793|NCT00867165|141777525|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-20.27|||<|0.001|TWO_SIDED|95.0|-23.39|-17.15|||ANCOVA|||||-17.15|-23.39|<0.001
70864456|NCT02586064|141214483|OTHER|||||||0.05|||||||t-test, 1 sided|||Baseline||||0.05
70864457|NCT02586064|141214483|OTHER|||||||0.04|||||||t-test, 1 sided|||End of Treatment||||0.04
70864458|NCT02586064|141214483|OTHER|||||||0.86|||||||t-test, 1 sided|||Change||||0.86
71138794|NCT00867165|141777526|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-21.37|||<|0.001|TWO_SIDED|95.0|-24.67|-18.08|||ANCOVA|||||-18.08|-24.67|<0.001
70864459|NCT02586064|141214483|OTHER||||||<|0.001|||||||t-test, 1 sided|||3 Month Post Treatment||||<0.001
70864460|NCT02586064|141214483|OTHER|||||||0.16|||||||t-test, 1 sided|||6 Month Post Treatment||||0.16
70864461|NCT02586064|141214484|OTHER|||||||0.45|||||||t-test, 1 sided|||Baseline||||0.45
71138795|NCT00867165|141777527|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-0.95||||0.733|TWO_SIDED|95.0|-6.46|4.55|||ANCOVA|||||4.55|-6.46|0.733
70864462|NCT02586064|141214484|OTHER|||||||0.71|||||||t-test, 1 sided|||End of Treatment||||0.71
70864463|NCT02586064|141214484|OTHER|||||||0.6|||||||t-test, 1 sided|||Change||||0.60
70864464|NCT02586064|141214484|OTHER|||||||0.13|||||||t-test, 1 sided|||3 Month Post Treatment||||0.13
71138796|NCT00867165|141777528|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|0.53||||0.863|TWO_SIDED|95.0|-5.59|6.66|||ANCOVA|||||6.66|-5.59|0.863
70864465|NCT02586064|141214484|OTHER|||||||0.8|||||||t-test, 1 sided|||6 Month Post Treatment||||0.80
70864466|NCT02586064|141214485|OTHER|||||||0.35|||||||t-test, 1 sided|||Baseline||||0.35
70864467|NCT02586064|141214485|OTHER|||||||0.11|||||||t-test, 1 sided|||End of Treatment||||0.11
71138797|NCT00867165|141777529|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|1.92||||0.501|TWO_SIDED|95.0|-3.71|7.56|||ANCOVA|||||7.56|-3.71|0.501
71138798|NCT00867165|141777530|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-24.18|||<|0.001|TWO_SIDED|95.0|-27.78|-20.58|||ANCOVA|||||-20.58|-27.78|<0.001
70864468|NCT02586064|141214485|OTHER|||||||0.74|||||||t-test, 1 sided|||Change||||0.74
70864469|NCT02586064|141214485|OTHER|||||||0.03|||||||t-test, 1 sided|||3 Month Post Treatment||||0.03
70864470|NCT02586064|141214485|OTHER|||||||0.22|||||||t-test, 1 sided|||6 Month Post Treatment||||0.22
70864471|NCT02586064|141214486|OTHER|||||||0.39|||||||t-test, 1 sided|||Baseline||||0.39
70864472|NCT02586064|141214486|OTHER|||||||0.15|||||||t-test, 1 sided|||End of Treatment||||0.15
70864473|NCT02586064|141214486|OTHER|||||||0.72|||||||t-test, 1 sided|||Change||||0.72
70864474|NCT02586064|141214486|OTHER|||||||0.04|||||||t-test, 1 sided|||3 Month Post Treatment||||0.04
70864475|NCT02586064|141214486|OTHER|||||||0.19|||||||t-test, 1 sided|||6 Month Post Treatment||||0.19
70864476|NCT02586064|141214487|OTHER|||||||0.33|||||||t-test, 1 sided|||Baseline||||0.33
70864477|NCT02586064|141214487|OTHER|||||||0.11|||||||t-test, 1 sided|||End of Treatment||||0.11
70864478|NCT02586064|141214487|OTHER|||||||0.88|||||||t-test, 1 sided|||Change||||0.88
70864479|NCT02586064|141214487|OTHER|||||||0.06|||||||t-test, 1 sided|||3 Month Post Treatment||||0.06
70864480|NCT02586064|141214487|OTHER|||||||0.56|||||||t-test, 1 sided|||6 Month Post Treatment||||0.56
70864481|NCT02586064|141214488|OTHER|||||||0.16|||||||t-test, 1 sided|||Baseline||||0.16
70864482|NCT02586064|141214488|OTHER|||||||0.06|||||||t-test, 1 sided|||End of Treatment||||0.06
70864483|NCT02586064|141214488|OTHER|||||||0.46|||||||t-test, 1 sided|||Change||||0.46
70864484|NCT02586064|141214488|OTHER|||||||0.001|||||||t-test, 1 sided|||3 Month Post Treatment||||0.001
70864485|NCT02586064|141214488|OTHER|||||||0.002|||||||t-test, 1 sided|||6 Month Post Treatment||||0.002
70864486|NCT02586064|141214489|OTHER|||||||0.24|||||||t-test, 1 sided|||Baseline||||0.24
70864487|NCT02586064|141214489|OTHER|||||||0.81|||||||t-test, 1 sided|||End of Treatment||||0.81
70864488|NCT02586064|141214489|OTHER|||||||0.24|||||||t-test, 1 sided|||Change||||0.24
70864489|NCT02586064|141214490|OTHER|||||||0.41|||||||t-test, 1 sided|||Baseline||||0.41
70864490|NCT02586064|141214490|OTHER|||||||0.21|||||||t-test, 1 sided|||End of Treatment||||0.21
70864491|NCT02586064|141214490|OTHER|||||||0.5|||||||t-test, 1 sided|||Change||||0.50
70864492|NCT02586064|141214491|OTHER|||||||0.7|||||||t-test, 1 sided|||Baseline||||0.70
70864493|NCT02586064|141214491|OTHER|||||||0.96|||||||t-test, 1 sided|||Week 4||||0.96
70864494|NCT02586064|141214491|OTHER|||||||0.59|||||||t-test, 1 sided|||Week 8||||0.59
70864495|NCT02586064|141214491|OTHER|||||||0.61|||||||t-test, 1 sided|||End of Treatment||||0.61
70864496|NCT02586064|141214491|OTHER|||||||0.84|||||||t-test, 1 sided|||Change||||0.84
70864497|NCT02586064|141214491|OTHER|||||||0.3|||||||t-test, 1 sided|||3 Month Follow Up||||0.30
71138799|NCT00867165|141777531|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-24.61|||<|0.001|TWO_SIDED|95.0|-28.06|-21.16|||ANCOVA|||||-21.16|-28.06|<0.001
71138800|NCT00867165|141777532|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-26.55|||<|0.001|TWO_SIDED|95.0|-30.35|-22.75|||ANCOVA|||||-22.75|-30.35|<0.001
71138801|NCT00867165|141777533|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-9.73||||0.137|TWO_SIDED|95.0|-22.73|3.27|||Constrained longitudinal data analysis|||||3.27|-22.73|0.137
71138802|NCT00867165|141777534|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-15.19||||0.005|TWO_SIDED|95.0|-26.05|-4.34|||Constrained longitudinal data analysis|||||-4.34|-26.05|0.005
71138803|NCT00867165|141777535|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-8.61||||0.149|TWO_SIDED|95.0|-20.44|3.23|||Constrained longitudinal data analysis|||||3.23|-20.44|0.149
71138804|NCT00867165|141777536|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-1.91||||0.373|TWO_SIDED|95.0|-6.15|2.32|||ANCOVA|||||2.32|-6.15|0.373
71138805|NCT00867165|141777537|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares mean|-19.76|||<|0.001|TWO_SIDED|95.0|-24.7|-14.82|||ANCOVA|||||-14.82|-24.70|<0.001
71138806|NCT00867165|141777538|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-20.83|||<|0.001|TWO_SIDED|95.0|-25.59|-16.07|||ANCOVA|||||-16.07|-25.59|<0.001
71138807|NCT00867165|141777539|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-23.48|||<|0.001|TWO_SIDED|95.0|-29.0|-17.97|||ANCOVA|||||-17.97|-29.00|<0.001
71138808|NCT00867165|141777540|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-22.29|||<|0.001|TWO_SIDED|95.0|-27.25|-17.34|||ANCOVA|||||-17.34|-27.25|<0.001
71138809|NCT00867165|141777541|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-24.5|||<|0.001|TWO_SIDED|95.0|-29.88|-19.12|||ANCOVA|||||-19.12|-29.88|<0.001
71138810|NCT00867165|141777542|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-25.15|||<|0.001|TWO_SIDED|95.0|-30.69|-19.62|||ANCOVA|||||-19.62|-30.69|<0.001
71138811|NCT00867165|141777543|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-29.31|||<|0.001|TWO_SIDED|95.0|-35.71|-22.91|||ANCOVA|||||-22.91|-35.71|<0.001
71138812|NCT00867165|141777544|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-28.35|||<|0.001|TWO_SIDED|95.0|-34.41|-22.29|||ANCOVA|||||-22.29|-34.41|<0.001
71138813|NCT00867165|141777545|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-19.28|||<|0.001|TWO_SIDED|95.0|-23.87|-14.7|||ANCOVA|||||-14.70|-23.87|<0.001
71138814|NCT00867165|141777546|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-46.11||||0.116|TWO_SIDED|95.0|-108.14|15.92|||Constrained longitudinal data analysis|||||15.92|-108.14|0.116
71138815|NCT00867165|141777547|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|17.27||||0.382|TWO_SIDED|95.0|-20.46|55.0|||Constrained longitudinal data analysis|||||55.00|-20.46|0.382
71138816|NCT00867165|141777548|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-49.61|||<|0.001|TWO_SIDED|95.0|-55.36|-43.87|||ANCOVA|||||-43.87|-55.36|<0.001
71138817|NCT00867165|141777549|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-58.52|||<|0.001|TWO_SIDED|95.0|-63.67|-53.38|||ANCOVA|||||-53.38|-63.67|<0.001
71138818|NCT00867165|141777550|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-61.02|||<|0.001|TWO_SIDED|95.0|-67.51|-54.53|||ANCOVA|||||-54.53|-67.51|<0.001
71138819|NCT00867165|141777551|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-62.74||||0.001|TWO_SIDED|95.0|-73.22|-52.26|||ANCOVA|||||-52.26|-73.22|0.001
71138820|NCT00867165|141777552|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-49.48|||<|0.001|TWO_SIDED|95.0|-54.83|-44.14|||ANCOVA|||||-44.14|-54.83|<0.001
71138821|NCT00867165|141777553|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-57.99|||<|0.001|TWO_SIDED|95.0|-62.87|-53.11|||ANCOVA|||||-53.11|-62.87|<0.001
71138822|NCT00867165|141777554|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-62.6|||<|0.001|TWO_SIDED|95.0|-68.54|-56.66|||ANCOVA|||||-56.66|-68.54|<0.001
71138823|NCT00867165|141777555|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-64.67|||<|0.001|TWO_SIDED|95.0|-74.11|-55.23|||ANCOVA|||||-55.23|-74.11|<0.001
71138824|NCT00867165|141777556|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-18.35|||<|0.001|TWO_SIDED|95.0|-24.7|-11.99|||ANCOVA|||||-11.99|-24.70|<0.001
71138825|NCT00867165|141777557|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-25.61|||<|0.001|TWO_SIDED|95.0|-31.2|-20.02|||ANCOVA|||||-20.02|-31.20|<0.001
71138826|NCT00867165|141777558|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-28.74|||<|0.001|TWO_SIDED|95.0|-34.89|-22.59|||ANCOVA|||||-22.59|-34.89|<0.001
71138827|NCT00867165|141777559|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-32.14|||<|0.001|TWO_SIDED|95.0|-40.38|-23.9|||ANCOVA|||||-23.90|-40.38|<0.001
71138828|NCT00867165|141777560|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|20.01||||0.001|TWO_SIDED|95.0|8.1|31.91|||ANCOVA|||||31.91|8.10|0.001
71138829|NCT00867165|141777561|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|26.29|||<|0.001|TWO_SIDED|95.0|13.99|38.58|||ANCOVA|||||38.58|13.99|<0.001
71138830|NCT00867165|141777562|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|36.7|||<|0.001|TWO_SIDED|95.0|24.12|49.28|||ANCOVA|||||49.28|24.12|<0.001
71138831|NCT00867165|141777563|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|24.05|||<|0.001|TWO_SIDED|95.0|10.43|37.67|||ANCOVA|||||37.67|10.43|<0.001
71138832|NCT03550378|141777572|SUPERIORITY||LS Mean Difference|-30.384|||<|0.001|TWO_SIDED|90.0|-41.27|-19.498|||ANCOVA|||||-19.498|-41.270|<0.001
71138833|NCT03546621|141777593|SUPERIORITY||||||<|0.0001|||||||Bonferroni-Holm|||For each of the three Myrcludex B treatment groups, a null hypothesis of no clinically significant difference in proportion of responders compared to the control group (Tenofovir only), at week 24, were tested using the one-sided Wald test for superiority, at a one-sided overall significance level of 0.05 adjusted for multiple testing according to Bonferroni-Holm, with the superiority limit (test margin) set to 5%.||||<.0001
71138834|NCT03546621|141777594|SUPERIORITY|||||||0.9818||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48. Two-sided Fisher's exact tests were used to test null hypothesis of no difference in the proportion of responders compared to the Tenofovir only group. Separate comparisons were made for each of the three Myrcludex B groups versus the control group, and the adjusted p-values were computed using the Bonferroni-Holm method.||||0.9818
70948077|NCT00267098|141396992|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.081|||||TWO_SIDED|95.0|-0.218|0.058||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in CI through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean CI change through 18 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Cardiac Index (CI) through 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Cardiac Index through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value.||0.058|-0.218|
71138835|NCT03546621|141777594|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value as smaller than 0.05|Bonferroni-Holm|||Week 48. Two-sided Fisher's exact tests were used to test null hypothesis of no difference in the proportion of responders compared to the Tenofovir only group. Separate comparisons were made for each of the three Myrcludex B groups versus the control group, and the adjusted p-values were computed using the Bonferroni-Holm method.||||1.0000
71138836|NCT03546621|141777594|SUPERIORITY|||||||0.7132||||||The threshold for statistical significance was p=0.05|Bonferroni-Holm|||Week 48. Two-sided Fisher's exact tests were used to test null hypothesis of no difference in the proportion of responders compared to the Tenofovir only group. Separate comparisons were made for each of the three Myrcludex B groups versus the control group, and the adjusted p-values were computed using the Bonferroni-Holm method.||||0.7132
71138837|NCT03546621|141777595|SUPERIORITY|||||||0.0232||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||"Fisher's exact test was used to test a null hypothesis of no difference in proportions against a two-sided alternative hypothesis. Separate tests were performed for each of the three Myrcludex B treatment groups against the control group, at week 24 and week 48, and adjusted p-values were computered using the Bonferroni-Holm method.~This analysis, and presentation of descriptive statistics, was repeated for the subgroups of patients with normal/abnormal baseline ALT values."||||0.0232
70864498|NCT02586064|141214491|OTHER|||||||0.16|||||||t-test, 1 sided|||6 Month Post Treatment||||0.16
70864499|NCT04308304|141214510|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|Geometric Mean Ratio (GMR)|0.69|||||TWO_SIDED|90.0|0.55|0.86||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.86|0.55|
71138838|NCT03546621|141777595|SUPERIORITY|||||||0.0047||||||The threshold for statistical significance was p=0.05|Bonferroni-Holm|||Fisher's exact test was used to test a null hypothesis of no difference in proportions against a two-sided alternative hypothesis. Separate tests were performed for each of the three Myrcludex B treatment groups against the control group, at week 24 and week 48, and adjusted p-values were computered using the Bonferroni-Holm method.||||0.0047
70864500|NCT04308304|141214510|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.66|||||TWO_SIDED|95.0|0.53|0.82||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.82|0.53|
70864501|NCT04308304|141214510|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.74|||||TWO_SIDED|95.0|0.55|1.0||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||1.00|0.55|
70864502|NCT04308304|141214510|OTHER|MK-1942 + Donepezil PK / MK-1942 PK Alone|GMR|0.77|||||TWO_SIDED|95.0|0.56|1.05||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||1.05|0.56|
71138839|NCT03546621|141777595|SUPERIORITY|||||||0.001||||||The threshold for statistical significance was p=0.05|Bonferroni-Holm|||Fisher's exact test was used to test a null hypothesis of no difference in proportions against a two-sided alternative hypothesis. Separate tests were performed for each of the three Myrcludex B treatment groups against the control group, at week 24 and week 48, and adjusted p-values were computered using the Bonferroni-Holm method.||||0.0010
71138840|NCT03546621|141777596|SUPERIORITY|||||||0.1642||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||"Week 24. The change from baseline to week 24 and week 48 in ALT levels was performed using van Elteren tests.~Fisher's exact test was used to test a null hypothesis of no difference in proportions (of patients with normal ALT values) against a two-sided alternative hypothesis. Separate tests were performed for each of the three Myrcludex B treatment groups against the control group, at week 24 and week 48, and adjusted p-values were computed using the Bonferroni-Holm method."||||0.1642
71138841|NCT03546621|141777596|SUPERIORITY|||||||0.0428||||||A test is considered statistically significant if the adjusted p-value is smaller than 0.05|Bonferroni-Holm|||Week 24||||0.0428
71138842|NCT03546621|141777596|SUPERIORITY|||||||0.0428||||||A test is considered statistically significant if the adjusted p-value is smaller than 0.05|Bonferroni-Holm|||Week 24||||0.0428
71138843|NCT03546621|141777596|SUPERIORITY|||||||0.2388||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Boferroni-Holm|||Week 48||||0.2388
71138844|NCT03546621|141777596|SUPERIORITY|||||||0.7157||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||0.7157
71138845|NCT03546621|141777596|SUPERIORITY|||||||0.2388||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||0.2388
70864503|NCT04308304|141214511|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|Geometric Mean Ratio (GMR)|0.69|||||TWO_SIDED|90.0|0.55|0.86||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.86|0.55|
71138846|NCT03546621|141777597|SUPERIORITY|||||||0.7416||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||"Week 24. Two-sided van Elteren tests, stratified by presence of cirrhosis, were used to test for differences compared to the control group.~Separate comparisons were made for each of the three MXB groups versus the control group, and adjusted p-values were computed using the Bonferroni-Holm method."||||0.7416
71138847|NCT03546621|141777597|SUPERIORITY|||||||0.4434||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 24||||0.4434
71138848|NCT03546621|141777597|SUPERIORITY|||||||0.7371||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 24.||||0.7371
71138849|NCT03546621|141777597|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
71138850|NCT03546621|141777597|SUPERIORITY|||||||0.9441||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||0.9441
71138851|NCT03546621|141777597|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
71138852|NCT03546621|141777598|SUPERIORITY||Bonferroni-Holm|||||0.5984||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||"Week 24. The change from baseline to Week 24 in HBsAg was performed using van Elteren tests. Tests were performed on log-10 transformed data.~Separare comparisons were made for each of the three Myrcludex B groups versus the control group, and the adjusted values were computed using the Bonferroni-Holm method."||||0.5984
71138853|NCT03546621|141777598|SUPERIORITY|||||||0.7529||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 24||||0.7529
71138854|NCT03546621|141777598|SUPERIORITY|||||||0.3305||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 24||||0.3305
70864504|NCT04308304|141214511|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.66|||||TWO_SIDED|95.0|0.53|0.82||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.82|0.53|
71138855|NCT03546621|141777598|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
71138856|NCT03546621|141777598|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
71138857|NCT03546621|141777598|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
71138858|NCT03546621|141777599|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||"Week 24. Two-sided van Elteren tests, stratified by presence of cirrhosis, were used to test for differences compared to the control group.~Tests were performed on log-10 transformed data. Separate comparisons were made for each of the three MXB groups versus the control group, and adjusted p-values were computed using the Bonferroni-Holm method."||||1.0000
71138859|NCT03546621|141777599|SUPERIORITY|||||||1|||||||Bonferroni-Holm|||Week 24.||||1.0000
71138860|NCT03546621|141777599|SUPERIORITY|||||||1|||||||Bonferroni-Holm|||Week 24||||1.0000
71138861|NCT03546621|141777599|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05|Bonferroni-Holm|||Week 48||||1.0000
71138862|NCT03546621|141777599|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
71138863|NCT03546621|141777599|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
71138864|NCT00462306|141777612|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||4000 parturients and 500 non-pregnant achieves 90% power to detect a difference of 3% positive Berlin Questionnaire rates between pregnant and non-pregnant women using a two sided chi squared test at a significance level of 0.05|Chi-squared, Corrected|||We hypothesized that the rate of positive Berlin questionnaires would be higher in pregnant women compared to age matched controls undergoing surgery.||||0.001
70864505|NCT04308304|141214511|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.74|||||TWO_SIDED|95.0|0.55|1.0||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||1.00|0.55|
71138865|NCT00462306|141777613|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Chi-squared, Corrected|||||||0.01
71138866|NCT05051579|141777624|SUPERIORITY||LS Mean difference (Final Values)|-6.5|||<|0.001|TWO_SIDED|95.0|-8.9|-4.2|||Mixed Models Analysis|||||-4.2|-8.9|<0.001
71138867|NCT05051579|141777624|SUPERIORITY||LS Mean difference (Final Values)|-9.2|||<|0.001|TWO_SIDED|95.0|-11.5|-6.9|||Mixed Models Analysis|||||-6.9|-11.5|<0.001
71138868|NCT05051579|141777624|SUPERIORITY||LS Mean difference (Final Values)|-10.2|||<|0.001|TWO_SIDED|95.0|-12.4|-8.0|||Mixed Models Analysis|||||-8.0|-12.4|<0.001
71138869|NCT05051579|141777624|SUPERIORITY||LS Mean difference (Final Values)|-10.6|||<|0.001|TWO_SIDED|95.0|-12.7|-8.4|||Mixed Models Analysis|||||-8.4|-12.7|<0.001
71138870|NCT05051579|141777625|OTHER||LS Mean difference (Final Values)|-7.1|||<|0.001|TWO_SIDED|95.0|-9.9|-4.2|||Mixed Models Analysis|||||-4.2|-9.9|<0.001
71138871|NCT05051579|141777625|OTHER||LS Mean difference (Final Values)|-10.1|||<|0.001|TWO_SIDED|95.0|-12.9|-7.3|||Mixed Models Analysis|||||-7.3|-12.9|<0.001
71138872|NCT05051579|141777625|OTHER||LS Mean difference (Final Values)|-11.1|||<|0.001|TWO_SIDED|95.0|-13.8|-8.4|||Mixed Models Analysis|||||-8.4|-13.8|<0.001
71138873|NCT05051579|141777625|OTHER||LS Mean difference (Final Values)|-12.3|||<|0.001|TWO_SIDED|95.0|-15.0|-9.6|||Mixed Models Analysis|||||-9.6|-15.0|<0.001
71138874|NCT05051579|141777626|OTHER||LS Mean difference (Final Values)|-6.9|||<|0.001|TWO_SIDED|95.0|-9.3|-4.4|||Mixed Models Analysis|||||-4.4|-9.3|<0.001
71138875|NCT05051579|141777626|OTHER||LS Mean difference (Final Values)|-10.2|||<|0.001|TWO_SIDED|95.0|-12.5|-7.8|||Mixed Models Analysis|||||-7.8|-12.5|<0.001
71138876|NCT05051579|141777626|OTHER||LS Mean difference (Final Values)|-10.8|||<|0.001|TWO_SIDED|95.0|-13.1|-8.5|||Mixed Models Analysis|||||-8.5|-13.1|<0.001
71138877|NCT05051579|141777626|OTHER||LS Mean difference (Final Values)|-11.2|||<|0.001|TWO_SIDED|95.0|-13.5|-8.9|||Mixed Models Analysis|||||-8.9|-13.5|<0.001
71138878|NCT05051579|141777627|OTHER||LS Mean difference (Final Values)|-7.4|||<|0.001|TWO_SIDED|95.0|-10.4|-4.3|||Mixed Models Analysis|||||-4.3|-10.4|<0.001
71138879|NCT05051579|141777627|OTHER||LS Mean difference (Final Values)|-11.2|||<|0.001|TWO_SIDED|95.0|-14.2|-8.3|||Mixed Models Analysis|||||-8.3|-14.2|<0.001
71138880|NCT05051579|141777627|OTHER||LS Mean difference (Final Values)|-11.8|||<|0.001|TWO_SIDED|95.0|-14.7|-9.0|||Mixed Models Analysis|||||-9.0|-14.7|<0.001
71138881|NCT05051579|141777627|OTHER||LS Mean difference (Final Values)|-13.0|||<|0.001|TWO_SIDED|95.0|-15.8|-10.2|||Mixed Models Analysis|||||-10.2|-15.8|<0.001
71138882|NCT05051579|141777628|OTHER||LS Mean difference (Final Values)|-4.4||||0.002|TWO_SIDED|95.0|-7.2|-1.6|||Mixed Models Analysis|||||-1.6|-7.2|0.002
71138883|NCT05051579|141777628|OTHER||LS Mean difference (Final Values)|-5.2|||<|0.001|TWO_SIDED|95.0|-8.0|-2.4|||Mixed Models Analysis|||||-2.4|-8.0|<0.001
71138884|NCT05051579|141777628|OTHER||LS Mean difference (Final Values)|-6.5|||<|0.001|TWO_SIDED|95.0|-9.2|-3.8|||Mixed Models Analysis|||||-3.8|-9.2|<0.001
71138885|NCT05051579|141777628|OTHER||LS Mean difference (Final Values)|-8.7|||<|0.001|TWO_SIDED|95.0|-11.3|-6.0|||Mixed Models Analysis|||||-6.0|-11.3|<0.001
71138886|NCT05051579|141777629|OTHER||LS Mean difference (Final Values)|-5.6|||<|0.001|TWO_SIDED|95.0|-8.8|-2.4|||Mixed Models Analysis|||||-2.4|-8.8|<0.001
71138887|NCT05051579|141777629|OTHER||LS Mean difference (Final Values)|-7.2|||<|0.001|TWO_SIDED|95.0|-10.3|-4.0|||Mixed Models Analysis|||||-4.0|-10.3|<0.001
71138888|NCT05051579|141777629|OTHER||LS Mean difference (Final Values)|-6.6|||<|0.001|TWO_SIDED|95.0|-9.7|-3.6|||Mixed Models Analysis|||||-3.6|-9.7|<0.001
71138889|NCT05051579|141777629|OTHER||LS Mean difference (Final Values)|-9.6|||<|0.001|TWO_SIDED|95.0|-12.7|-6.6|||Mixed Models Analysis|||||-6.6|-12.7|<0.001
71138890|NCT05051579|141777630|OTHER||LS Mean difference (Final Values)|-2.4|||<|0.001|TWO_SIDED|95.0|-3.2|-1.6|||Mixed Models Analysis|||||-1.6|-3.2|<0.001
70864506|NCT04308304|141214511|OTHER|MK-1942 + Donepezil PK / MK-1942 PK Alone|GMR|0.77|||||TWO_SIDED|95.0|0.56|1.05||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||1.05|0.56|
71138891|NCT05051579|141777630|OTHER||LS Mean difference (Final Values)|-3.5|||<|0.001|TWO_SIDED|95.0|-4.3|-2.6|||Mixed Models Analysis|||||-2.6|-4.3|<0.001
71138892|NCT05051579|141777630|OTHER||LS Mean difference (Final Values)|-3.8|||<|0.001|TWO_SIDED|95.0|-4.6|3.0|||Mixed Models Analysis|||||3.0|-4.6|<0.001
71138893|NCT05051579|141777630|OTHER||LS Mean difference (Final Values)|-3.9|||<|0.001|TWO_SIDED|95.0|-4.7|-3.1|||Mixed Models Analysis|||||-3.1|-4.7|<0.001
71138894|NCT05051579|141777631|OTHER||LS Mean difference (Final Values)|-2.5|||<|0.001|TWO_SIDED|95.0|-3.6|-1.5|||Mixed Models Analysis|||||-1.5|-3.6|<0.001
71138895|NCT05051579|141777631|OTHER||LS Mean difference (Final Values)|-3.8|||<|0.001|TWO_SIDED|95.0|-4.8|-2.8|||Mixed Models Analysis|||||-2.8|-4.8|<0.001
71138896|NCT05051579|141777631|OTHER||LS Mean difference (Final Values)|-4.2|||<|0.001|TWO_SIDED|95.0|-5.2|-3.2|||Mixed Models Analysis|||||-3.2|-5.2|<0.001
71138897|NCT05051579|141777631|OTHER||LS Mean difference (Final Values)|-4.6|||<|0.001|TWO_SIDED|95.0|-5.6|-3.6|||Mixed Models Analysis|||||-3.6|-5.6|<0.001
71138898|NCT05051579|141777632|OTHER||Odds Ratio (OR)|9.96|||<|0.001|TWO_SIDED|95.0|3.61|27.44|||Regression, Logistic|||||27.44|3.61|<0.001
71138899|NCT05051579|141777632|OTHER||Odds Ratio (OR)|27.97|||<|0.001|TWO_SIDED|95.0|8.15|96.01|||Regression, Logistic|||||96.01|8.15|<0.001
71138900|NCT05051579|141777632|OTHER||Odds Ratio (OR)|27.36|||<|0.001|TWO_SIDED|95.0|8.71|85.91|||Regression, Logistic|||||85.91|8.71|<0.001
71138901|NCT05051579|141777632|OTHER||Odds Ratio (OR)|23.59|||<|0.001|TWO_SIDED|95.0|7.65|72.77|||Regression, Logistic|||||72.77|7.65|<0.001
71138902|NCT05051579|141777633|OTHER||Odds Ratio (OR)|19.93|||<|0.001|TWO_SIDED|95.0|3.47|114.4|||Regression, Logistic|||||114.40|3.47|<0.001
71138903|NCT05051579|141777633|OTHER||Odds Ratio (OR)|39.52|||<|0.001|TWO_SIDED|95.0|6.95|224.83|||Regression, Logistic|||||224.83|6.95|<0.001
71138904|NCT05051579|141777633|OTHER||Odds Ratio (OR)|74.97|||<|0.001|TWO_SIDED|95.0|13.16|427.18|||Regression, Logistic|||||427.18|13.16|<0.001
71138905|NCT05051579|141777633|OTHER||Odds Ratio (OR)|72.23|||<|0.001|TWO_SIDED|95.0|12.62|413.21|||Regression, Logistic|||||413.21|12.62|<0.001
71138906|NCT05051579|141777634|OTHER||Odds Ratio (OR)|7.79|||<|0.001|TWO_SIDED|95.0|2.9|20.92|||Regression, Logistic|||||20.92|2.90|<0.001
71138907|NCT05051579|141777634|OTHER||Odds Ratio (OR)|25.07|||<|0.001|TWO_SIDED|95.0|7.49|83.91|||Regression, Logistic|||||83.91|7.49|<0.001
71138908|NCT05051579|141777634|OTHER||Odds Ratio (OR)|34.76|||<|0.001|TWO_SIDED|95.0|8.17|147.86|||Regression, Logistic|||||147.86|8.17|<0.001
71138909|NCT05051579|141777634|OTHER||Odds Ratio (OR)|28.01|||<|0.001|TWO_SIDED|95.0|8.15|96.29|||Regression, Logistic|||||96.29|8.15|<0.001
71138910|NCT05051579|141777635|OTHER||Odds Ratio (OR)|8.27|||<|0.001|TWO_SIDED|95.0|2.59|26.45|||Regression, Logistic|||||26.45|2.59|<0.001
71138911|NCT05051579|141777635|OTHER||Odds Ratio (OR)|15.64|||<|0.001|TWO_SIDED|95.0|4.83|50.68|||Regression, Logistic|||||50.68|4.83|<0.001
71138912|NCT05051579|141777635|OTHER||Odds Ratio (OR)|27.24|||<|0.001|TWO_SIDED|95.0|8.39|88.38|||Regression, Logistic|||||88.38|8.39|<0.001
71138913|NCT05051579|141777635|OTHER||Odds Ratio (OR)|20.88|||<|0.001|TWO_SIDED|95.0|6.59|66.17|||Regression, Logistic|||||66.17|6.59|<0.001
71138914|NCT01650194|141777645|OTHER|||||||0.615|||||||t-test, 2 sided|||Testosterone biomarker results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||0.6150
71138915|NCT01650194|141777647|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Cortisol biomarker results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
71138916|NCT01650194|141777648|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Androstenedione biomarker results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
71138917|NCT01650194|141777649|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Progesterone biomarker results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
71138918|NCT01650194|141777650|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Pregnenolone biomarker results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
71138919|NCT01650194|141777651|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Testosterone blood results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
70864507|NCT04308304|141214512|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|Geometric Mean Ratio (GMR)|0.67|||||TWO_SIDED|90.0|0.52|0.87||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.87|0.52|
71138920|NCT01650194|141777653|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Cortisol blood results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
71138921|NCT01650194|141777654|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Androstenedione blood results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
71138922|NCT01650194|141777655|OTHER|||||||0.0002|||||||t-test, 2 sided|||Progesterone blood results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||0.0002
71138923|NCT01650194|141777656|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Pregnenolone blood results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
71138924|NCT00880698|141777670|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-3.1||||0.62|TWO_SIDED|95.0|-20.6|14.8||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference and 95% confidence interval (RotaTeq minus Placebo) in percentage of HIV-uninfected participants experiencing a new grade \>=3 adverse event|||14.8|-20.6|0.62
71138925|NCT00880698|141777670|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.7||||1|TWO_SIDED|95.0|-21.0|23.4||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference and 95% confidence interval (RotaTeq minus Placebo) in percentage of HIV-infected participants experiencing a new grade \>=3 adverse event|||23.4|-21.0|1.00
71138926|NCT00880698|141777671|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|29.9|||<|0.001|TWO_SIDED|95.0|11.5|46.1||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for SNA G1 in RotaTeq group minus Placebo group.|SNA G1||46.1|11.5|<0.001
71138927|NCT00880698|141777671|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|49.8|||<|0.001|TWO_SIDED|95.0|27.1|68.6||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for SNA G1 in RotaTeq group minus Placebo group.|SNA G1||68.6|27.1|<0.001
71138928|NCT00880698|141777671|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|7.1||||0.2|TWO_SIDED|95.0|-11.3|24.8||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for SNA G2 in RotaTeq group minus Placebo group.|SNA G2||24.8|-11.3|0.20
71138929|NCT00880698|141777671|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|14.2||||0.19|TWO_SIDED|95.0|-10.6|36.7||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for SNA G2 in RotaTeq group minus Placebo group.|SNA G2||36.7|-10.6|0.19
71138930|NCT00880698|141777671|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|19.3|||<|0.001|TWO_SIDED|95.0|0.9|36.4||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for SNA G3 in RotaTeq group minus Placebo group.|SNA G3||36.4|0.9|<0.001
71138931|NCT00880698|141777671|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|29.4|||<|0.001|TWO_SIDED|95.0|4.7|50.6||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for SNA G3 in RotaTeq group minus Placebo group.|SNA G3||50.6|4.7|<0.001
71138932|NCT00880698|141777671|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|26.4|||<|0.001|TWO_SIDED|95.0|8.0|42.9||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for SNA G4 in RotaTeq group minus Placebo group.|SNA G4||42.9|8.0|<0.001
71138933|NCT00880698|141777671|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|58.6|||<|0.001|TWO_SIDED|95.0|37.2|75.9||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for SNA G4 in RotaTeq group minus Placebo group.|SNA G4||75.9|37.2|<0.001
71138934|NCT00880698|141777671|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|16.4||||0.024|TWO_SIDED|95.0|-1.7|34.2||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for SNA P1 in RotaTeq group minus Placebo group.|SNA P1||34.2|-1.7|0.024
71138935|NCT00880698|141777671|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.7||||0.34|TWO_SIDED|95.0|-12.0|35.5||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for SNA P1 in RotaTeq group minus Placebo group.|SNA P1||35.5|-12.0|0.34
71138936|NCT00880698|141777671|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|51.4|||<|0.001|TWO_SIDED|95.0|34.3|66.3||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for IgA in RotaTeq group minus Placebo group.|IgA||66.3|34.3|<0.001
71138937|NCT00880698|141777671|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|65.1|||<|0.001|TWO_SIDED|95.0|42.7|81.7||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for IgA in RotaTeq group minus Placebo group.|IgA||81.7|42.7|<0.001
71138938|NCT00851786|141777718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|0.45|0.69||The p-value was adjusted for baseline gpELISA titer, measurement time (week 6 vs. week 12), CD4 stratum and age.|Linear mixed effect model|Natural log transformed gpELISA titers after one or two doses of vaccine was modeled.||Null hypothesis: VZV antibody titer measured by gpELISA, after 1 or 2 doses of ZOSTAVAX/placebo is the same between ZOSTAVAX arm and the placebo arm||0.69|0.45|<.001
71138939|NCT04290039|141777731|OTHER|Estimation only|Geometric ratio of least-square means|0.579|||||TWO_SIDED|90.0|0.5265|0.636|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.6360|0.5265|
71138940|NCT04290039|141777731|OTHER|Estimation only|Geometric ratio of least-square means|0.349|||||TWO_SIDED|90.0|0.3171|0.3839|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.3839|0.3171|
71138941|NCT04290039|141777731|OTHER|Estimation only|Geometric ratio of least-square means|0.603|||||TWO_SIDED|90.0|0.5524|0.6582|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.6582|0.5524|
71138942|NCT04290039|141777732|OTHER|Estimation only|Geometric ratio of least-square means|0.546|||||TWO_SIDED|90.0|0.4971|0.6004|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.6004|0.4971|
71138943|NCT04290039|141777732|OTHER|Estimation only|Geometric ratio of least-square means|0.306|||||TWO_SIDED|90.0|0.2788|0.3367|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.3367|0.2788|
71138944|NCT04290039|141777732|OTHER|Estimation only|Geometric ratio of least-square means|0.561|||||TWO_SIDED|90.0|0.5104|0.6164|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.6164|0.5104|
71138945|NCT04290039|141777733|OTHER|Estimation only|Geometric ratio of least-square means|0.549|||||TWO_SIDED|90.0|0.4273|0.7118|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.7118|0.4273|
71138946|NCT04290039|141777733|OTHER|Estimation only|Geometric ratio of least-square means|0.049|||||TWO_SIDED|90.0|0.0381|0.0641|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.0641|0.0381|
70948078|NCT00267098|141396993|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|0.047|||||TWO_SIDED|95.0|-0.095|0.192||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in CI through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean CI change through 24 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Cardiac Index (CI) through 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Cardiac Index through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value.||0.192|-0.095|
71138947|NCT04290039|141777733|OTHER|Estimation only|Geometric ratio of least-square means|0.09|||||TWO_SIDED|90.0|0.0695|0.1167|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.1167|0.0695|
71138948|NCT04233801|141777755|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-0.99|||<|0.0001|TWO_SIDED|95.0|-1.28|-0.71|||Mixed model repeated measures|||||-0.71|-1.28|< 0.0001
71138949|NCT04233801|141777755|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.26|-0.7|||Mixed model repeated measures|||||-0.70|-1.26|< 0.0001
70948079|NCT00267098|141396994|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|29.3|||||TWO_SIDED|95.0|10.04|48.64||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in IVMD through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean IVMD change through 6 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in IVMD through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in IVMD through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value. A positive value reflected reduction in IVMD.||48.640|10.040|
71138950|NCT04233801|141777756|OTHER|Logistic regression including treatment, baseline Estimated glomerular filtration rate (eGFR), background therapy, and continuous baseline HbA1c.|Odds Ratio (OR)|2.29||||0.1375|TWO_SIDED|95.0|0.77|6.83|||Regression, Logistic|||||6.83|0.77|0.1375
71138951|NCT04233801|141777756|OTHER|Logistic regression including treatment, baseline Estimated glomerular filtration rate (eGFR), background therapy, and continuous baseline HbA1c.|Odds Ratio (OR)|6.01||||0.0008|TWO_SIDED|95.0|2.11|17.1|||Regression, Logistic|||||17.10|2.11|0.0008
71138952|NCT04233801|141777757|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-2.0|||<|0.0001|TWO_SIDED|95.0|-2.66|-1.34|||Mixed model repeated measures|||||-1.34|-2.66|< 0.0001
71138953|NCT04233801|141777757|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-1.32|||<|0.0001|TWO_SIDED|95.0|-1.96|-0.67|||Mixed model repeated measures|||||-0.67|-1.96|< 0.0001
71138954|NCT04233801|141777758|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-3.6||||0.0774|TWO_SIDED|95.0|-7.61|0.4|||Mixed model repeated measures|||||0.40|-7.61|0.0774
71138955|NCT04233801|141777758|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-1.01||||0.616|TWO_SIDED|95.0|-4.98|2.96|||Mixed model repeated measures|||||2.96|-4.98|0.6160
71138956|NCT04233801|141777759|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-1.78||||0.1222|TWO_SIDED|95.0|-4.05|0.48|||Mixed model repeated measures|||||0.48|-4.05|0.1222
70864508|NCT04308304|141214512|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.68|||||TWO_SIDED|95.0|0.52|0.87||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.87|0.52|
71138957|NCT04233801|141777759|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|0.65||||0.5687|TWO_SIDED|95.0|-1.59|2.89|||Mixed model repeated measures|||||2.89|-1.59|0.5687
71138958|NCT04233801|141777760|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-20.05||||0.0003|TWO_SIDED|95.0|-30.73|-9.38|||Mixed model repeated measures|||||-9.38|-30.73|0.0003
71138959|NCT04233801|141777760|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-24.13|||<|0.0001|TWO_SIDED|95.0|-34.72|-13.54|||Mixed model repeated measures|||||-13.54|-34.72|<0.0001
71138960|NCT04233801|141777761|OTHER|The Analysis of covariance (ANCOVA) model included treatment and background therapy as classification effects, baseline PPG and baseline Estimated glomerular filtration rate (eGFR) as the linear covariates.|Adjusted mean|-56.32|||<|0.0001|TWO_SIDED|95.0|-78.22|-34.41|||ANCOVA|||||-34.41|-78.22|<0.0001
71138961|NCT04233801|141777761|OTHER|The Analysis of covariance (ANCOVA) model included treatment and background therapy as classification effects, baseline PPG and baseline Estimated glomerular filtration rate (eGFR) as the linear covariates.|Adjusted mean|-60.71|||<|0.0001|TWO_SIDED|95.0|-82.31|-39.11|||ANCOVA|||||-39.11|-82.31|<0.0001
71138962|NCT04233801|141777762|OTHER||Odds Ratio (OR)|1.76||||0.2422|TWO_SIDED|95.0|0.68|4.55|||Regression, Logistic|Logistic regression including treatment and continuous baseline glycosylated haemoglobin A1c (HbA1c).|Odds ratio used Placebo as the reference group.|||4.55|0.68|0.2422
71138963|NCT04233801|141777762|OTHER||Odds Ratio (OR)|0.85||||0.7661|TWO_SIDED|95.0|0.29|2.5|||Regression, Logistic|Logistic regression including treatment and continuous baseline glycosylated haemoglobin A1c (HbA1c).|Odds ratio used Placebo as the reference group.|||2.50|0.29|0.7661
71138964|NCT01169103|141777766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7||95.0|||||t-test, 2 sided|||We assumed that mean decrease in visceral fat in our population would be 0.85\*standard deviation score (SDS). Therefore, 18 subjects in each group would be required in order for us to have an 81.7% chance of detecting a significant difference in the mean 6-month changes in visceral adiposity between the groups at a 5% significance level by rejecting the null hypothesis that there is no difference in change in visceral fat following administration of rhGH or placebo in obese adolescent girls.||||0.70
71138965|NCT01169103|141777766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||t-test, 2 sided|||Change in SAT p-value||||0.30
71138966|NCT01169103|141777767|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.93
70864509|NCT04308304|141214512|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.79|||||TWO_SIDED|95.0|0.59|1.06||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||1.06|0.59|
71138967|NCT01169103|141777768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0|||||t-test, 2 sided|||Change in Total Cholesterol p-value||||0.03
71138968|NCT01169103|141777768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Change in Triglyceride p-value||||0.57
71138969|NCT01169103|141777768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062|||||||t-test, 2 sided|||Change in Low-density lipoprotein p-value||||0.062
71138970|NCT01169103|141777768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0396|||||||t-test, 2 sided|||Change in High-density lipoprotein p-value||||0.0396
71138971|NCT01169103|141777769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.58||95.0|||||t-test, 2 sided|||||||0.58
71138972|NCT01169103|141777770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04||95.0|||||t-test, 2 sided|||||||0.04
71138973|NCT04755816|141777771|OTHER|Estimates and confidence intervals are provided|Win Ratio|1.29|||||TWO_SIDED|95.0|1.08|1.54||||||"Dietary Sodium Intervention includes those in treatment group B and D. No Dietary Sodium Intervention includes those in treatment group A and C. By the unmatched pairs win ratio method, each participant receiving the intervention will be compared to each participant not receiving the intervention. For each comparison, winners will be determined according to the hierarchy described above. The win ratio is the number winners divided by the number of losers associated with the intervention."||1.54|1.08|
71138974|NCT04755816|141777772|OTHER|Estimates and confidence intervals are provided|Win Ratio|1.29|||||TWO_SIDED|95.0|1.08|1.54||||||"Clinical Worsening Intervention includes those in treatment group C and D. No Clinical Worsening Intervention includes those in group A and B. By the unmatched pairs win ratio method, each participant receiving the intervention will be compared to each participant not receiving the intervention. For each comparison, winners will be determined according to the hierarchy described above. The win ratio is the number winners divided by the number of losers associated with the intervention."||1.54|1.08|
71138975|NCT04755816|141777774|OTHER|Estimates and confidence intervals are provided|Hazard Ratio (HR)|1.096|||||TWO_SIDED|95.0|0.321|3.743||||||Dietary Sodium Intervention includes those in treatment group B and D. No Dietary Sodium Intervention includes those in treatment group A and C.||3.743|0.321|
71138976|NCT04755816|141777775|OTHER|Estimates and confidence intervals are provided|Slope|-15.37|||||TWO_SIDED|95.0|-37.5|6.76|||||"The total score for the MLHFQ ranges from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life. The change in MLHFQ is defined as MLHFQ at Week 12 minus MLHFQ at Week 0."|Dietary Sodium Intervention includes those in treatment group B and D. No Dietary Sodium Intervention includes those in treatment group A and C. Simple linear regression models will be used to assess the outcome of change in MLHFQ over 12 weeks as a function of treatment group assignment. Beta coefficients and 95% confidence intervals will be reported.||6.76|-37.5|
71138977|NCT04755816|141777776|OTHER|Estimates and confidence intervals are provided|Hazard Ratio (HR)|0.556|||||TWO_SIDED|95.0|0.163|1.901||||||Clinical Worsening Intervention includes those in treatment group C and D. No Clinical Worsening Intervention includes those in treatment group A and B.||1.901|0.163|
71138978|NCT04755816|141777777|OTHER|Estimates and confidence intervals are provided|Slope|-12.98|||||TWO_SIDED|95.0|-33.67|7.72|||||"The total score for the MLHFQ ranges from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life. The change in MLHFQ is defined as MLHFQ at Week 12 minus MLHFQ at Week 0."|Clinical Worsening Intervention includes those in treatment group C and D. No Clinical Worsening Intervention includes those in treatment group A and B. Simple linear regression models will be used to assess the outcome of change in MLHFQ over 12 weeks as a function of treatment group assignment. Beta coefficients and 95% confidence intervals will be reported.||7.72|-33.67|
71138979|NCT02792231|141777778|SUPERIORITY||rate ratio|0.416|||<|0.001|TWO_SIDED|95.0|0.309|0.56|||negative binomial regression model|||Obtained from fitting a negative binomial regression model with log-link to the number of relapses, adjusted for treatment and region as factors, number of relapses in previous year, baseline EDSS, baseline number of Gd-enhancing lesions and the patient's age at baseline as covariates. The natural log of the time-in-study was used as offset to annualize the relapse rate.||0.560|0.309|<0.001
71138980|NCT02792231|141777779|SUPERIORITY||Hazard Ratio (HR)|0.657||||0.003|TWO_SIDED|95.0|0.5|0.863|||Regression, Cox|||Pooled data - this study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||0.863|0.500|0.003
71138981|NCT02792231|141777780|SUPERIORITY||Hazard Ratio (HR)|0.662||||0.038|TWO_SIDED|95.0|0.449|0.977|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||0.977|0.449|0.038
71138982|NCT02792231|141777781|SUPERIORITY||Hazard Ratio (HR)|0.676||||0.012|TWO_SIDED|95.0|0.498|0.917|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||0.917|0.498|0.012
71138983|NCT02792231|141777782|SUPERIORITY||Hazard Ratio (HR)|0.759||||0.215|TWO_SIDED|95.0|0.49|1.174|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||1.174|0.490|0.215
71138984|NCT02792231|141777783|SUPERIORITY||Hazard Ratio (HR)|1.355||||0.092|TWO_SIDED|95.0|0.952|1.928|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||1.928|0.952|0.092
71138985|NCT02792231|141777784|SUPERIORITY||Hazard Ratio (HR)|1.523||||0.09|TWO_SIDED|95.0|0.936|2.477|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||2.477|0.936|0.090
71138986|NCT02792231|141777785|SUPERIORITY||rate ratio|0.061|||<|0.001|TWO_SIDED|95.0|0.037|0.101|||negative binomial regression model|||||0.101|0.037|<.001
71138987|NCT02792231|141777786|SUPERIORITY||rate ratio|0.21|||<|0.001|TWO_SIDED|95.0|0.17|0.27|||negative binomial regression model|||Month 12||0.27|0.17|<.001
70864510|NCT04308304|141214512|OTHER|MK-1942 + Donepezil PK / MK-1942 PK Alone|GMR|0.74|||||TWO_SIDED|95.0|0.51|1.08||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||1.08|0.51|
70864511|NCT04308304|141214513|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|Geometric Mean Ratio (GMR)|0.62|||||TWO_SIDED|90.0|0.48|0.8||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.80|0.48|
70864512|NCT04308304|141214513|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.67|||||TWO_SIDED|95.0|0.55|0.81||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.81|0.55|
70864513|NCT04308304|141214513|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.68|||||TWO_SIDED|95.0|0.49|0.93||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.93|0.49|
70864514|NCT04308304|141214513|OTHER|MK-1942 + Donepezil PK / MK-1942 PK Alone|GMR|0.72|||||TWO_SIDED|95.0|0.54|0.98||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.98|0.54|
70864515|NCT04308304|141214518|OTHER|Donepezil Accumulation Ratio (Day 28/Day -1)|Geometric mean|1.34|STANDARD_ERROR_OF_MEAN|52.4||||||||||||||||
70864516|NCT04308304|141214519|OTHER|Donepezil Accumulation Ratio (Day 28/Day -1)|Geometric mean|1.22|STANDARD_ERROR_OF_MEAN|52.4||||||||||||||||
70864517|NCT04308304|141214520|OTHER|Donepezil Accumulation Ratio (Day 28/Day -1)|Geometric mean|1.46|STANDARD_ERROR_OF_MEAN|60.8||||||||||||||||
70864518|NCT04502979|141214539|SUPERIORITY||Mean Difference (Net)|0.31|STANDARD_ERROR_OF_MEAN|0.21||0.07|TWO_SIDED|95.0|-0.11|0.73||One-sided p-value for directional hypothesis. The threshold for statistical significance is p \< 0.05.|Mixed Models Analysis|||||0.73|-0.11|0.07
70864519|NCT04502979|141214540|SUPERIORITY||Mean Difference (Net)|-121.16|STANDARD_ERROR_OF_MEAN|65.73||0.04|TWO_SIDED|95.0|-252.73|10.41||One-sided p-value for directional hypothesis. The threshold for statistical significance is p \< 0.05.|Mixed Models Analysis|||||10.41|-252.73|0.04
70864520|NCT01892865|141214548|SUPERIORITY_OR_OTHER||Mean Difference (Net)|23.6||||0.024|TWO_SIDED|95.0|3.15|44.0|||t-test, 2 sided|||The null hypothesis was that there would be no difference in predictive imprecision for the end of the operative day between the two arms||44|3.15|0.024
71138988|NCT02792231|141777786|SUPERIORITY||rate ratio|0.19|||<|0.001|TWO_SIDED|95.0|0.12|0.31|||negative binomial regression model|||Month 24||0.31|0.12|<.001
71138989|NCT02792231|141777786|SUPERIORITY||rate ratio|0.15|||<|0.001|TWO_SIDED|95.0|0.13|0.19|||negative binomial regression model|||End of Study||0.19|0.13|<.001
71138990|NCT02792231|141777787|SUPERIORITY||Geo-mean ratio|0.89|||<|0.001|TWO_SIDED|95.0|0.85|0.93|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||Month 3||0.93|0.85|<.001
71138991|NCT02792231|141777787|SUPERIORITY||Geo-mean ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.7|0.79|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||Month 12||0.79|0.70|<.001
71138992|NCT02792231|141777787|SUPERIORITY||Geo-mean ratio|0.76|||<|0.001|TWO_SIDED|95.0|0.71|0.81|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||Month 24||0.81|0.71|<.001
71138993|NCT02792231|141777788|SUPERIORITY||Mean Difference (Net)|0.07||||0.128|TWO_SIDED|95.0|-0.02|0.15|||random coefficient model|||||0.15|-0.02|0.128
71138994|NCT02792231|141777791|SUPERIORITY||Hazard Ratio (HR)|0.641||||0.002|TWO_SIDED|95.0|0.486|0.847|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||0.847|0.486|0.002
70864521|NCT01892865|141214548|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.16||||0.04|TWO_SIDED|95.0|1.01|1.34|||Poisson regression|||Null hypothesis: There would be no difference in throughput between the two arms||1.34|1.01|0.04
70864522|NCT01892865|141214549|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.16||||0.04|TWO_SIDED|95.0|1.01|1.34|||Poisson Regression|||Null hypothesis was that there was no difference in throughput between the two scheduling methods||1.34|1.01|0.04
70864523|NCT01892865|141214550|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||Null hypothesis: There would be no difference in personnel satisfaction between the groups||||0.04
70864524|NCT01892865|141214551|SUPERIORITY_OR_OTHER|||||||0.44|||||||Chi-squared|||Null hypothesis was that there would be no difference in the adverse event rates between the two scheduling methodologies||||0.44
70864525|NCT03950791|141214561|SUPERIORITY||Mann-Whitney U|3864.0|STANDARD_ERROR_OF_MEAN|302.0||0.89|TWO_SIDED|||||Not adjusted for multiple comparisons, p \< .05 used as threshold for statistical significance|Independent-samples Mann-Whitney U|No adjustments for multiple comparisons|Standardized Test Statistic = .139|Morphine equivalent dosage outcome variables were not normally distributed (skewness values between 4.5 and 4.8, kurtosis values between 25.7 and 30.0), which necessitated non-parametric analysis using independent-samples Mann-Whitney U Test||||.89
70864526|NCT02719327|141214564|SUPERIORITY||Slope|-2.18||||0.17|TWO_SIDED|95.0|-5.36|0.99||ASL values at 18 months were regressed on treatment group (IPE vs placebo) statistically controlling for age at baseline visit and ASL measured at baseline visit.|Regression, Linear|||The proposed study aims to investigate the effects of 18 months of IPE vs. placebo on regional cerebral blood flow in the bilateral posterior cingulate gyrus as measured by arterial spin-labeling MRI . IPE was hypothesized to improve regional cerebral blood flow over placebo after 18 months.||0.99|-5.36|0.17
70864527|NCT02719327|141214565|SUPERIORITY||Slope|0.11||||0.12|TWO_SIDED|95.0|-0.04|0.25|||Regression, Linear|18 month Beta-amyloid(1-42) was regressed on group (IPE vs placebo) and covariates age at baseline visit and Beta-amyloid(1-42) at baseline visit.|Placebo group is the reference group.|Beta-amyloid(1-42) concentration in CSF was log-transformed prior to analysis to approximate a normal distribution.||0.25|-0.04|.12
70864528|NCT02719327|141214565|SUPERIORITY||Slope|0.045||||0.05|TWO_SIDED|95.0|0.004|0.061|||Regression, Linear|log-transformed 18 month pTau181 was regressed on group (IPE vs placebo) and covariates age at baseline and log-transformed ptau181at baseline visit.|Placebo group is the reference group.|Phosphorylated tau (pTau181) measured in CSF was log-transformed prior to analysis to approximate a normal distribution.||0.061|0.004|0.05
70948080|NCT00267098|141396995|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|21.83|||||TWO_SIDED|95.0|2.841|40.87||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in IVMD through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean IVMD change through 12 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in IVMD through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in IVMD through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value. A positive value reflected reduction in IVMD.||40.870|2.841|
71138995|NCT02792231|141777792|SUPERIORITY||Hazard Ratio (HR)|0.657||||0.008|TWO_SIDED|95.0|0.481|0.898|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||0.898|0.481|0.008
71138996|NCT04073186|141777816|SUPERIORITY|The superiority of the First wearing Cycle was concluded if the lower confidence limit of leastsquare mean as greater than 32.|Least-square Mean|59.3|STANDARD_ERROR_OF_MEAN|2.37|||TWO_SIDED|95.0|54.6|64.0|||Linear Mixed Model|the Kenward and Roger method was used for the denominator degrees of freedom.||||64.0|54.6|
71138997|NCT04073186|141777817|SUPERIORITY|The superiority of the Test lens was concluded if the upper confidence limit of least-square mean was below the pre-defined threshold 0.10 logMAR.|Least-square Mean|-0.084|STANDARD_ERROR_OF_MEAN|0.0191|||TWO_SIDED|95.0|-0.124|-0.044||Distance (4 Meter)|Linear Mixed Model|The Kenward and Roger Method was used for the demoninator degrees of freedom.||||-0.044|-0.124|
71138998|NCT04073186|141777817|SUPERIORITY|The superiority of the Test lens was concluded if the upper confidence limit of least-square mean was below the pre-defined threshold 0.17 logMAR.|Least-square Mean|-0.028|STANDARD_ERROR_OF_MEAN|0.0191|||TWO_SIDED|95.0|-0.068|0.012|||Linear Mixed Model|The Kenward and Roger Method was used for the demoninator degrees of freedom||Intermediate (64 CM)||0.012|-0.068|
70864529|NCT02719327|141214565|SUPERIORITY||Slope|0.046||||0.07|TWO_SIDED|95.0|-0.0008|0.106||18 months total Tau was regressed on Group (IPE vs placebo) and covariates age at baseline and total Tau at baseline.|Regression, Linear||Placebo group was the reference group.|Total tau was log-transformed prior to analysis to better approximate a normal distribution.||0.106|-0.0008|.07
70864530|NCT02719327|141214566|SUPERIORITY||Slope|0.006||||0.48|TWO_SIDED|95.0|-0.009|0.023|||Linear Mixed Effects model|Covariates included education level, gender, and age at baseline visit.|Placebo group was the reference group.|Four cognitive tests were standardized (baseline mean and standard deviation) prior to averaging to create the ADCS Preclinical Alzheimer Cognitive Composite (ADCS-PACC) score. The final composite score was standardized again using baseline mean and standard deviation (range -3.15 to 3.10). Higher scores indicate better cognitive performance. A linear mixed effects model was used to determine if change in ADCS-PACC composite scores was modified by treatment group.||0.023|-0.009|.48
70864531|NCT01470859|141214567|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|t-test, 2 sided|independent sample t-test The statistical analysis was performed on the changes of PDRP Z score between levodopa and pramipexole groups.||||||0.84
70864532|NCT01470859|141214567|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|t-test, 2 sided|independent sample t-test The statistical analysis was performed to compare the PDRP Z scores between levodopa and pramipexole groups at V1||||||0.93
70864533|NCT01470859|141214567|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|t-test, 2 sided|independent sample t-test The statistical analysis was performed to compare the PDRP Z scores between levodopa and pramipexole groups at V5||||||0.31
71138999|NCT04073186|141777817|SUPERIORITY|The superiority of the Test lens was concluded if the upper confidence limit of least-square mean was below the pre-defined threshold 0.17 logMAR|Least-square Means|0.037|STANDARD_ERROR_OF_MEAN|0.0191|||TWO_SIDED|95.0|-0.003|0.077|||Linear Mixed Model|The Kenward and Roger Method was used for the demoninator degrees of freedom||Near (40 CM)||0.077|-0.003|
71139000|NCT04073186|141777818|SUPERIORITY|The superiority of the Test lens at 4-week followup compared to it at 2-week follow-up will beconcluded if the lower confidence limit of leastsquare mean difference is greater than 0.|Least-square Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|2.03|||TWO_SIDED|95.0|-8.1|-0.1|||Linear Mixed Model|the Kenward and Roger method was used for the denominator degrees of freedom.|LSM difference was calculated as Second Wearing Cycle minus First Wearing Cycle|||-0.1|-8.1|
71139001|NCT00558246|141777902|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence is demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of INTRADERMAL SUTURE successful subjects) does not exceed 12%.|Differences in proportion of successes|0.0||||1|TWO_SIDED|95.0|-5.9|5.9|||McNemar||The level of significance for statistical testing was 0.05 for this study.|||5.9|-5.9|1.0000
71139002|NCT00558246|141777903|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71139003|NCT00558246|141777904|SUPERIORITY_OR_OTHER|||||||1||95.0|||||McNemar|||||||1.0000
71139004|NCT00558246|141777905|SUPERIORITY_OR_OTHER|||||||0.2266|||||||McNemar|||||||0.2266
71139005|NCT00558246|141777906|SUPERIORITY_OR_OTHER|||||||0.5078||0.0|||||McNemar|||||||0.5078
71139006|NCT05552027|141777911|SUPERIORITY||||||<|0.001||||||At the completion of scenario A (a full child safety seat installation), the participants using the CCS app had significantly fewer errors present compared to the control group.|Chi-squared|||||||<.001
71139007|NCT05552027|141777911|SUPERIORITY||||||<|0.01||||||At the end of scenario B (loose harness straps), participants using the CCS app had significantly fewer errors present compared to the control group.|Chi-squared|||||||<.01
71139008|NCT05552027|141777911|SUPERIORITY||||||<|0.01||||||At the end of scenario C (loose attachment at the base), like the other two scenarios, participants using the CCS app had significantly fewer errors present compared to the control group.|Chi-squared|||||||<.01
71139009|NCT00423657|141777919|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% confidence interval (CI) for the observed difference in the primary outcome measure between ceftaroline and vancomycin plus aztreonam was calculated. Noninferiority was concluded if the lower limit of the 95%CI was higher than -10%.|Risk Difference (RD)|-0.4|||||TWO_SIDED|95.0|-5.8|5.0|||||Risk difference corresponds to Ceftaroline clinical cure rate minus Vancomycin plus Aztreonam clinical cure rate. The confidence interval was calculated using the Miettinen and Nurminen method without adjustment.|The primary objective of this study was to determine the noninferiority in clinical cure rate of ceftaroline in comparison with vancomycin plus aztreonam in adult subjects with cSSSI.||5.0|-5.8|
71139010|NCT02795117|141777927|EQUIVALENCE|provides 85% power of success|equivalence ratio|96.4|||||TWO_SIDED|90.0|91.0|105.4||No p-value was calculated for bioequivalence, only a T/R ratio and 90% confidence interval|ANOVA|||||105.4|91.0|
71139011|NCT02795117|141777928|EQUIVALENCE|provides 85% power of success|Equivalence difference|-6.48|||||TWO_SIDED|90.0|-18.31|1.85|||Wald's method|||||1.85|-18.31|
71139012|NCT02653326|141777929|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||||||0.63
71139013|NCT02653326|141777930|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||||||0.32
70864534|NCT01470859|141214568|SUPERIORITY_OR_OTHER|||||||0.691|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS II scores at V1 scores between the levodopa and pramipexole groups||||||0.691
71139014|NCT04621448|141777954|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.048|TWO_SIDED|95.0|0.01|4.39|||Mixed Models Analysis||The mean difference estimate of 2.2 was confirmed. It is slightly different than the difference of the raw change values \[+.7 - (-1.7) = 2.4\] because it comes from the mixed effects model.|||4.39|0.01|0.048
71139015|NCT04621448|141777955|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.603|TWO_SIDED|95.0|-4.12|2.4|||Mixed Models Analysis|||||2.40|-4.12|0.603
71139016|NCT04621448|141777956|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.734|TWO_SIDED|95.0|-2.75|3.92|||Mixed Models Analysis|||||3.92|-2.75|0.734
71139017|NCT04621448|141777957|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.159|TWO_SIDED|95.0|-0.62|3.74|||Mixed Models Analysis|||||3.74|-0.62|0.159
70864535|NCT01470859|141214568|SUPERIORITY_OR_OTHER|||||||0.706|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS II scores at V2 scores between the levodopa and pramipexole groups||||||0.706
71139018|NCT04621448|141777958|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.818|TWO_SIDED|95.0|-1.97|1.56|||Mixed Models Analysis|||||1.56|-1.97|0.818
71139019|NCT04621448|141777959|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.089|TWO_SIDED|95.0|-0.26|3.51|||Mixed Models Analysis|||||3.51|-0.26|0.089
71139020|NCT04621448|141777960|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.631|TWO_SIDED|95.0|-0.96|1.58|||Mixed Models Analysis|||||1.58|-0.96|0.631
71139021|NCT04621448|141777961|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.484|TWO_SIDED|95.0|-0.71|1.49|||Mixed Models Analysis|||||1.49|-0.71|0.484
71139022|NCT04621448|141777962|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.81|TWO_SIDED|95.0|-2.36|3.01|||Mixed Models Analysis|||||3.01|-2.36|0.81
71139023|NCT04621448|141777963|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.384|TWO_SIDED|95.0|-0.77|2.0|||Mixed Models Analysis|||||2.00|-0.77|0.384
71139024|NCT04621448|141777964|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.509|TWO_SIDED|95.0|-1.65|0.81|||Mixed Models Analysis|||||0.81|-1.65|0.509
71139025|NCT04621448|141777965|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.021|TWO_SIDED|95.0|0.24|3.01|||Mixed Models Analysis|||||3.01|0.24|0.021
71139026|NCT04621448|141777966|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.156|TWO_SIDED|95.0|-1.94|0.31|||Mixed Models Analysis|||||0.31|-1.94|0.156
70864536|NCT01470859|141214568|SUPERIORITY_OR_OTHER|||||||0.635|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS II scores at V5 scores between the levodopa and pramipexole groups||||||0.635
71139027|NCT04621448|141777967|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.582|TWO_SIDED|95.0|-0.62|1.1|||Mixed Models Analysis|||||1.10|-0.62|0.582
70864537|NCT01470859|141214568|SUPERIORITY_OR_OTHER|||||||0.341|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS III scores at V1 scores between the levodopa and pramipexole groups||||||0.341
70864538|NCT01470859|141214568|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS III scores at V2 scores between the levodopa and pramipexole groups||||||0.049
70864539|NCT01470859|141214568|SUPERIORITY_OR_OTHER|||||||0.874|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS III scores at V5 scores between the levodopa and pramipexole groups||||||0.874
70864540|NCT01470859|141214569|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the PDQ39 scores between levodopa and pramipexole group at V1||||||0.720
70864541|NCT01470859|141214569|SUPERIORITY_OR_OTHER|||||||0.867|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the PDQ39 scores between levodopa and pramipexole group at V5||||||0.867
70864542|NCT01470859|141214570|SUPERIORITY_OR_OTHER|||||||0.793|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|indenpendent U test|independent U test The statistical analysis was performed to compare the H\&Y stages between levodopa and pramipexole group at V1||||||0.793
70864543|NCT01470859|141214570|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the H\&Y stages between levodopa and pramipexole groups at V5||||||0.430
70864544|NCT01470859|141214571|SUPERIORITY_OR_OTHER|||||||0.345|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|Chi-squared|The statistical analysis was performed to compare the clinical improvement between levodopa and pramipexole groups at V2||||||0.345
70864545|NCT01470859|141214571|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|Chi-squared|The statistical analysis was performed to compare the clinical improvement between levodopa and pramipexole groups at V5||||||0.410
70864546|NCT05203289|141214615|OTHER||Ratio of geometric means (%)|101.88|||||TWO_SIDED|90.0|93.31|111.23|||||"The estimated parameter was the adjusted geometric mean ratios (%) of BI 695501: (40 mg/0.4 mL (T))/(40 mg/0.8 mL (R)).~Geometric standard error= 105.455."|The statistical model used for the analysis of the primary endpoints was an analysis of covariance (ANCOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANCOVA model. This model included effects accounting for the following sources of variation: 'treatment', 'location of trial medication injection' and 'baseline body weight' (continuous).||111.23|93.31|
70864547|NCT05203289|141214616|OTHER||Ratio of geometric means (%)|105.38|||||TWO_SIDED|90.0|95.06|116.81|||||"The estimated parameter was the adjusted geometric mean ratios (%) of BI 695501: (40 mg/0.4 mL (T))/(40 mg/0.8 mL (R)).~Geometric standard error= 106.431."|The statistical model used for the analysis of the primary endpoints was an analysis of covariance (ANCOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANCOVA model. This model included effects accounting for the following sources of variation: 'treatment', 'location of trial medication injection' and 'baseline body weight' (continuous).||116.81|95.06|
70864548|NCT05203289|141214617|OTHER||Ratio of geometric means (%)|91.29|||||TWO_SIDED|90.0|84.38|98.76|||||"The estimated parameter was the adjusted geometric mean ratios (%) of BI 695501: (40 mg/0.4 mL (T))/(40 mg/0.8 mL (R)).~Geometric standard error= 104.874."|The statistical model used for the analysis of the primary endpoints was an analysis of covariance (ANCOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANCOVA model. This model included effects accounting for the following sources of variation: 'treatment', 'location of trial medication injection' and 'baseline body weight' (continuous).||98.76|84.38|
70864549|NCT05021081|141214618|OTHER|The least-square means (i.e., adjusted means) of photopic contrast sensitivity at 6 cpd was estimated separately under conditions with glare source and without glare source. This endpoint was not statistically tested, and consequentially statistical interferences was not made.|Least-square Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.114|||TWO_SIDED|95.0|-0.7|-0.21|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as With glare minus Without glare|The sample size was chosen based on resources in conjunction, subject matter experts, and any available literature. To help ensure the glare source intensity, a small pilot investigation per the ANSI Z80.12-2007 standard was interpreted to be about 20 subjects to complete Phase 1, which should be sufficient to evaluate the mean photopic contrast sensitivity with and without the glare source.||-0.21|-0.70|
70864550|NCT05021081|141214619|OTHER|The least-square means (i.e., adjusted means) of mesopic contrast sensitivity at 6 cpd was estimated separately under conditions with glare source and without glare source. This endpoint was not statistically tested, and consequentially statistical interferences was not made.|Least-square Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.102|||TWO_SIDED|95.0|-0.81|-0.36|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as With glare minus Without glare|The sample size was chosen based on resources in conjunction, subject matter experts, and any available literature. To help ensure the glare source intensity, a small pilot investigation per the ANSI Z80.12-2007 standard was interpreted to be about 20 subjects to complete Phase 1, which should be sufficient to evaluate the mean mesopic contrast sensitivity with and without the glare source.||-0.36|-0.81|
70872190|NCT02270957|141229606|SUPERIORITY|||||||0.587|TWO_SIDED|95.0||||None of the endpoints were met in any pre-specified unbiased Full Analysis Set analysis|Chi-squared|||||||0.587
71139028|NCT04621448|141777968|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.271|TWO_SIDED|95.0|-1.21|0.34|||Mixed Models Analysis|||||0.34|-1.21|0.271
71139029|NCT04621448|141777969|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.834|TWO_SIDED|95.0|-1.52|1.88|||Mixed Models Analysis|||||1.88|-1.52|0.834
71139030|NCT04621448|141777970|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.529|TWO_SIDED|95.0|-1.62|3.15|||Mixed Models Analysis|||||3.15|-1.62|0.529
70864551|NCT05021081|141214620|SUPERIORITY|Superiority was declared if the upper bound of the 2-sided 95% confidence interval of the mean difference was below 0.|Least-square Mean Difference|0.019|STANDARD_ERROR_OF_MEAN|0.024|||TWO_SIDED|95.0|-0.029|0.068|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as Test minus Control|Given no historical data is available, the sample size was not determined based on any empirical sample size calculation. A power analysis was conducted using a paired sample t-test (exact method) with a 2-sided type I error rate 0.05 to estimate statistical power based on different assumptions. The power analysis showed that the statistical power for testing superiority would be approximately 80% or higher with the effect size of -0.05 (mean difference: Test minus Control).||0.068|-0.029|
70864552|NCT02651467|141214623|SUPERIORITY_OR_OTHER||Difference of Least Square mean|-0.88|||<|0.0001|TWO_SIDED|95.0|-1.181|-0.584||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|For the Week 8 comparisons of the two Treatments against the Placebo Control, Dunnett's multiplicity adjustment is applied.||-0.584|-1.181|<0.0001
70864553|NCT02651467|141214623|SUPERIORITY_OR_OTHER||Diference of Least Square mean|-1.04|||<|0.0001|TWO_SIDED|95.0|-1.333|-0.738||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|For the Week 8 comparisons of the two Treatments against the control, Dunnett's multiplicity adjustment is applied.||-0.738|-1.333|<0.0001
70864554|NCT02651467|141214624|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.15||||0.2478||95.0|-0.107|0.413||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.413|-0.107|0.2478
70864555|NCT02024529|141214629|SUPERIORITY|||||||0.97||||||Adjusted for baseline WOMAC score|ANCOVA|||||||0.97
70864556|NCT02024529|141214630|SUPERIORITY|||||||0.75||||||Adjusted for baseline WOMAC score|ANCOVA|||||||0.75
71139031|NCT04621448|141777971|SUPERIORITY|||||||0.377|||||||Poisson regression|||||||0.377
70864557|NCT02024529|141214631|SUPERIORITY|||||||0.18|||||||ANCOVA|Adjusted for baseline WOMAC Score.||||||0.18
70864558|NCT02024529|141214632|SUPERIORITY|||||||0.81|||||||ANCOVA|Adjusted for baseline WOMAC Score.||||||0.81
70864559|NCT01480089|141214639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.308|STANDARD_ERROR_OF_MEAN|0.777||0.098|TWO_SIDED|95.0|-2.83|0.214|||t-test, 2 sided|||The null hypothesis is that the mean VAS score 2 hours post surgery is equivalent for individuals randomized to Intraperitoneal Ropivacaine(AIR) and those randomized to Atomized Intraperitoneal Saline (AIS).||0.214|-2.830|.098
70864560|NCT01480089|141214640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.065|STANDARD_ERROR_OF_MEAN|0.53||0.9|TWO_SIDED|95.0|-1.103|0.973|||t-test, 2 sided|||The null hypothesis is that the mean VAS score 12 hours post surgery is equivalent for individuals randomized to Intraperitoneal Ropivacaine(AIR) and those randomized to Atomized Intraperitoneal Saline (AIS).||0.973|-1.103|.90
70864561|NCT00631696|141214641|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A non-inferiority margin of 20% was used to test the hypothesis. The null hypothesis is that the difference (PGB - PBO) in the proportion of participants with ≥50% reduction in sperm concentration is ≥20% and the alternative hypothesis is that the difference in proportion of participant with ≥50% reduction in sperm concentration is \<20%.|percentage difference|6.0|||||TWO_SIDED|95.0|-2.29|14.3|||Confidence Interval Approach||The confidence interval was based on asymptotic normal distribution.|Study powered to show non-inferiority (NI) of pregabalin (PGB) to placebo (PBO) on the percentage of participants (N) with a ≥50% reduction in MSC from Bsl to end of washout (Week (Wk) 26, or last assessment on or after Wk 12 if Wk 26 not done). NI to be declared if upper bound of 95% CI for difference between PGB and PBO not \>20%. Assuming proportion of N with 50% reduction to be 6% for both groups, sample size N=65 per group would provide \>90% power to show NI of PGB to PBO.||14.30|-2.29|
70864562|NCT00631696|141214642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12||||0.3462|TWO_SIDED|95.0|-0.385|0.136||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||0.136|-0.385|0.3462
70864563|NCT00631696|141214643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13||||0.3652|TWO_SIDED|95.0|-0.42|0.156||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||0.156|-0.420|0.3652
70864564|NCT00631696|141214644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.1204|TWO_SIDED|95.0|-0.464|0.054||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||0.054|-0.464|0.1204
70864565|NCT00631696|141214645|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|24.65||||0.2875|TWO_SIDED|95.0|-20.999|70.302||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||70.302|-20.999|0.2875
70864566|NCT00631696|141214646|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|32.93||||0.1699|TWO_SIDED|95.0|-14.292|80.158||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||80.158|-14.292|0.1699
71139032|NCT04621448|141777972|SUPERIORITY|||||||0.043|||||||Poisson regression|||||||0.043
71139033|NCT01506271|141777993|NON_INFERIORITY|Non-inferiority test based on unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|1.1|||<|0.001|TWO_SIDED|95.0|-6.2|8.6|||Miettinen and Nurminen||Relebactam minus Placebo|MK-7655 250 mg - Placebo: Percentage Difference||8.6|-6.2|< 0.001
70948081|NCT00267098|141396996|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|26.53|||||TWO_SIDED|95.0|6.247|47.19||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in IVMD through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean IVMD change through 18 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in IVMD through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in IVMD through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value. A positive value reflected reduction in IVMD.||47.190|6.247|
70948082|NCT00267098|141396997|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|23.32|||||TWO_SIDED|95.0|1.999|44.53||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in IVMD through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean IVMD change through 24 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in IVMD through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in IVMD through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value. A positive value reflected reduction in IVMD.||44.530|1.999|
70948083|NCT00267098|141396998|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.047|||||TWO_SIDED|95.0|-0.18|0.089||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in E/A through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean E/A change through 6 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in E:A ratio (E/A) through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in E:A ratio through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value.||0.089|-0.180|
71139034|NCT01506271|141777993|NON_INFERIORITY|Non-inferiority test based on unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|3.7|||<|0.001|TWO_SIDED|95.0|-2.0|10.8|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||10.8|-2.0|< 0.001
71139035|NCT01506271|141777994|OTHER|Test for a non-zero difference.|Percentage Difference|0.0||||0.979|TWO_SIDED|95.0|-4.7|4.5|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||4.5|-4.7|0.979
71139036|NCT01506271|141777994|OTHER|Test for a non-zero difference.|Percentage Difference|-1.8||||0.153|TWO_SIDED|95.0|-6.2|1.5|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||1.5|-6.2|0.153
71139037|NCT01506271|141777995|OTHER|Test for a non-zero difference.|Percentage Difference|0.9||||0.324|TWO_SIDED|95.0|-2.4|4.7|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||4.7|-2.4|0.324
71139038|NCT01506271|141777995|OTHER|Test for a non-zero difference|Percentage Difference|0.0|||>|0.999|TWO_SIDED|95.0|-3.3|3.2|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||3.2|-3.3|> 0.999
71139039|NCT01506271|141777996|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|7.5|||||TWO_SIDED|95.0|-5.4|20.1|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||20.1|-5.4|
71139040|NCT01506271|141777996|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|6.2|||||TWO_SIDED|95.0|-6.7|18.8|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||18.8|-6.7|
71139041|NCT01506271|141777997|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-3.6|||||TWO_SIDED|95.0|-10.3|2.4|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||2.4|-10.3|
71139042|NCT01506271|141777997|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|2.5|||||TWO_SIDED|95.0|-5.0|10.1|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||10.1|-5.0|
71139043|NCT01506271|141777998|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.0|||||TWO_SIDED|95.0|-4.5|12.7|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||12.7|-4.5|
71139044|NCT01506271|141777998|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.1|||||TWO_SIDED|95.0|-4.4|12.8|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||12.8|-4.4|
71139045|NCT01506271|141777999|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.0|||||TWO_SIDED|95.0|-4.0|3.9|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||3.9|-4.0|
71139046|NCT01506271|141777999|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|-0.9|||||TWO_SIDED|95.0|-4.8|2.4|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||2.4|-4.8|
71139047|NCT01506271|141778000|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-6.7|2.3|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||2.3|-6.7|
71139048|NCT01506271|141778000|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.7|||||TWO_SIDED|95.0|-3.7|7.4|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||7.4|-3.7|
71139049|NCT01506271|141778001|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-2.6|||||TWO_SIDED|95.0|-7.5|0.6|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||0.6|-7.5|
71139050|NCT01506271|141778001|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-6.7|2.4|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||2.4|-6.7|
71139051|NCT01506271|141778002|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.6|||||TWO_SIDED|95.0|-4.7|8.1|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Diarrhoea||8.1|-4.7|
71139052|NCT01506271|141778002|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.6|||||TWO_SIDED|95.0|-4.6|8.2|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Diarrhoea||8.2|-4.6|
71139053|NCT01506271|141778002|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.2|||||TWO_SIDED|95.0|-7.3|6.9|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Nausea||6.9|-7.3|
71139054|NCT01506271|141778002|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.7|||||TWO_SIDED|95.0|-6.5|8.0|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Nausea||8.0|-6.5|
71139055|NCT01506271|141778002|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|3.4|||||TWO_SIDED|95.0|-2.3|9.6|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Vomiting||9.6|-2.3|
71139056|NCT01506271|141778002|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|5.1|||||TWO_SIDED|95.0|-0.7|11.8|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Vomiting||11.8|-0.7|
71139057|NCT01506271|141778002|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-7.6|3.5|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Postoperative Infection||3.5|-7.6|
71139058|NCT01506271|141778002|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-2.7|||||TWO_SIDED|95.0|-8.4|2.2|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Postoperative Infection||2.2|-8.4|
71139059|NCT01506271|141778002|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.9|||||TWO_SIDED|95.0|-2.4|4.7|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Seroma||4.7|-2.4|
71139060|NCT01506271|141778002|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.3|||||TWO_SIDED|95.0|1.0|9.7|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Seroma||9.7|1.0|
71139061|NCT01506271|141778002|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.8|||||TWO_SIDED|95.0|-5.0|6.6|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - ALT increased||6.6|-5.0|
71139062|NCT01506271|141778002|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.8|||||TWO_SIDED|95.0|-4.9|6.7|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - ALT increased||6.7|-4.9|
71139063|NCT01506271|141778002|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.6|||||TWO_SIDED|95.0|-3.7|7.3|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - AST increased||7.3|-3.7|
71139064|NCT01506271|141778002|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.7|||||TWO_SIDED|95.0|-3.7|7.4|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - AST increased||7.4|-3.7|
71139065|NCT01506271|141778002|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.9|||||TWO_SIDED|95.0|-6.5|4.2|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Lipase increased||4.2|-6.5|
71139066|NCT01506271|141778002|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-7.2|3.0|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Lipase increased||3.0|-7.2|
71139067|NCT01506271|141778002|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-3.5|||||TWO_SIDED|95.0|-8.7|-0.3|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Hypertension||-0.3|-8.7|
71139068|NCT01506271|141778002|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.9|||||TWO_SIDED|95.0|-6.4|4.3|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Hypertension||4.3|-6.4|
71139069|NCT01506271|141778003|SUPERIORITY||Percentage Difference|0.0|||>|0.999|TWO_SIDED|95.0|0.0|0.0|||Fisher Exact||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||0|0|> 0.999
71139070|NCT01506271|141778003|SUPERIORITY||Percentage Difference|0.0|||>|0.999|TWO_SIDED|95.0|0.0|0.0|||Fisher Exact||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||0|0|> 0.999
71139071|NCT01506271|141778004|NON_INFERIORITY|Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|-1.4||||0.001|TWO_SIDED|95.0|-9.1|6.0|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||6.0|-9.1|0.001
71139072|NCT01506271|141778004|NON_INFERIORITY|Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|-2.1||||0.002|TWO_SIDED|95.0|-9.7|5.3|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||5.3|-9.7|0.002
71139073|NCT01506271|141778005|NON_INFERIORITY|Two participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|0.0|||<|0.001|TWO_SIDED|95.0|-6.3|6.2|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||6.2|-6.3|< 0.001
71139074|NCT01506271|141778005|NON_INFERIORITY|Two participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|2.4|||<|0.001|TWO_SIDED|95.0|-2.0|8.3|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||8.3|-2.0|< 0.001
71139075|NCT01506271|141778006|NON_INFERIORITY|Eight participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|-0.1|||<|0.001|TWO_SIDED|95.0|-6.7|6.4|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||6.4|-6.7|< 0.001
70948084|NCT00267098|141396999|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.117|||||TWO_SIDED|95.0|-0.287|0.058||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in E/A through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean E/A change through 12 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in E:A ratio (E/A) through 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in E:A ratio through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value.||0.058|-0.287|
71139076|NCT01506271|141778006|NON_INFERIORITY|Eight participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|0.1|||<|0.001|TWO_SIDED|95.0|-6.3|6.5|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||6.5|-6.3|< 0.001
71139077|NCT01506271|141778007|NON_INFERIORITY|Non-inferiority test based on Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|-1.3||||0.002|TWO_SIDED|95.0|-9.6|6.9|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||6.9|-9.6|0.002
71139078|NCT01506271|141778007|NON_INFERIORITY|Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|0.4|||<|0.001|TWO_SIDED|95.0|-7.2|8.2|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||8.2|-7.2|< 0.001
71139079|NCT01506271|141778008|NON_INFERIORITY|Eight participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|0.0|||<|0.001|TWO_SIDED|95.0|-7.4|7.4|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||7.4|-7.4|< 0.001
71139080|NCT01506271|141778008|NON_INFERIORITY|Eight participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|1.4|||<|0.001|TWO_SIDED|95.0|-5.2|8.6|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||8.6|-5.2|< 0.001
71139081|NCT01506271|141778010|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.0|||||TWO_SIDED|95.0|-7.3|5.1|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Blood, lymphatic||5.1|-7.3|
71139082|NCT01506271|141778010|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-4.4|||||TWO_SIDED|95.0|-10.3|0.1|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Blood, lymphatic||0.1|-10.3|
71139083|NCT01506271|141778010|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.0|||||TWO_SIDED|95.0|-5.2|5.0|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Cardiac disorder||5.0|-5.2|
71139084|NCT01506271|141778010|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.8|||||TWO_SIDED|95.0|-4.5|6.3|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Cardiac disorder||6.3|-4.5|
71139085|NCT01506271|141778010|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|5.6|||||TWO_SIDED|95.0|-3.9|15.3|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - GI disorders||15.3|-3.9|
71139086|NCT01506271|141778010|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.1|||||TWO_SIDED|95.0|-5.4|13.6|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - GI disorders||13.6|-5.4|
71139087|NCT01506271|141778010|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.2|||||TWO_SIDED|95.0|-2.0|11.0|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Gen. dis \& admin.||11.0|-2.0|
71139088|NCT01506271|141778010|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.7|||||TWO_SIDED|95.0|-4.2|7.8|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Gen. dis \& admin.||7.8|-4.2|
71139089|NCT01506271|141778010|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.1|||||TWO_SIDED|95.0|-3.6|12.0|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Infect. \& Infest.||12.0|-3.6|
71139090|NCT01506271|141778010|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.7|||||TWO_SIDED|95.0|-6.5|8.0|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Infect. \& Infest.||8.0|-6.5|
71139091|NCT01506271|141778010|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.0|||||TWO_SIDED|95.0|-7.3|5.1|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Injury, poison.||5.1|-7.3|
71139092|NCT01506271|141778010|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.6|||||TWO_SIDED|95.0|-5.0|8.5|||||Relebactam minus Placebo|Relebactam 1250mg - Placebo: Percentage Difference - Injury, poison.||8.5|-5.0|
71139093|NCT01506271|141778010|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.2|||||TWO_SIDED|95.0|-9.8|7.4|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Investigations||7.4|-9.8|
71139094|NCT01506271|141778010|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.9|||||TWO_SIDED|95.0|-10.5|6.5|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Investigations||6.5|-10.5|
71139095|NCT01506271|141778010|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-2.7|||||TWO_SIDED|95.0|-8.4|2.2|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Nervous System||2.2|-8.4|
71139096|NCT01506271|141778010|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-2.7|||||TWO_SIDED|95.0|-8.4|2.2|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Nervous System||2.2|-8.4|
71139097|NCT01506271|141778010|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.1|||||TWO_SIDED|95.0|-5.7|5.4|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Psychiatric disorders||5.4|-5.7|
70864567|NCT00631696|141214647|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.12||||0.7958|TWO_SIDED|95.0|-52.804|40.558||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||40.558|-52.804|0.7958
70864568|NCT00631696|141214648|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.08||||0.4094|TWO_SIDED|95.0|-3.645|1.494||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||1.494|-3.645|0.4094
70864569|NCT00631696|141214649|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15||||0.9064|TWO_SIDED|95.0|-2.649|2.352||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||2.352|-2.649|0.9064
70864570|NCT00631696|141214650|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.86||||0.4666|TWO_SIDED|95.0|-3.207|1.477||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||1.477|-3.207|0.4666
70864571|NCT01426438|141214659|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Sign test|Stratified exact Wilcoxon signed rank test. Stratified by screening HDL-C level and statin use within 90 days prior to study entry.||||||0.28
70864572|NCT01426438|141214659|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Sign test|Stratified exact Wilcoxon signed rank test. Stratified by screening HDL-C level and statin use within 90 days prior to study entry.||||||0.19
70864573|NCT02122458|141214675|SUPERIORITY||Mean Difference (Net)|0.448||||0.05|TWO_SIDED|95.0|-8.66|9.56||Given the preliminary nature of this treatment study and the small number of participants the p-value was not adjusted for multiple comparisons.|Mixed Models Analysis|An Adjusted Rank Transform was applied to the data prior to applying the mixed model analyses.||The null hypothesis evaluated by the HHIA was that self-perceived hearing handicap would not reduce from baseline to 6-months post-fitting.||9.56|-8.66|.05
70864574|NCT02122458|141214676|SUPERIORITY|||||||0.05||||||Given the small sample size and the preliminary nature of this study, the p-value was not adjusted for multiple comparisons.|ANOVA|||||||.05
70864575|NCT03161093|141214680|SUPERIORITY||Least Squares Mean|-0.68|STANDARD_ERROR_OF_MEAN|0.18||0.0002|TWO_SIDED|95.0|-1.028|-0.324|||Mixed Models Analysis|||||-0.324|-1.028|0.0002
70864576|NCT03161093|141214681|SUPERIORITY||Least Squares Mean|-0.7|STANDARD_ERROR_OF_MEAN|0.178|<|0.0001|TWO_SIDED|95.0|-1.046|-0.346|||Mixed Models Analysis|||||-0.346|-1.046|<0.0001
71139098|NCT01506271|141778010|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.1|||||TWO_SIDED|95.0|-5.7|5.5|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Psychiatric disorders||5.5|-5.7|
71139099|NCT01506271|141778010|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-7.2|3.0|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Renal \& Urinary||3.0|-7.2|
71139100|NCT01506271|141778010|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-7.2|3.0|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Renal \& Urinary||3.0|-7.2|
70864577|NCT03161093|141214682|SUPERIORITY||Least Squares Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.254||0.7036|TWO_SIDED|95.0|-0.594|0.401|||Mixed Models Analysis|||||0.401|-0.594|0.7036
70864578|NCT03161093|141214683|SUPERIORITY||Least Squares Mean|-0.18|STANDARD_ERROR_OF_MEAN|0.243||0.4605|TWO_SIDED|95.0|-0.657|0.297|||Mixed Models Analysis|||||0.297|-0.657|0.4605
70864579|NCT00091442|141214729|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.5988||95.0|0.86|1.3||Not adjusted for multiple comparison.|Log Rank|||Null Hypothesis: Designed to detect an improvement in median survival from 15 months to 19.5 months with 80% power.||1.3|0.86|0.5988
70864580|NCT00091442|141214730|SUPERIORITY_OR_OTHER|||||||0.0085||95.0||||Not adjusted for multiple comparison|Cochran-Mantel-Haenszel|||Null hypothesis - no difference in response rate between the two treatment groups.||||0.0085
70864581|NCT00091442|141214731|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65|||<|0.0001||95.0|0.55|0.77|||Log Rank|||"Null hypothersis - no difference in Time to Progression (TTP) between the two treatment groups.~Designed to detect an improvement in median TTP from 6 months to 7.8 months with 80% power, assuming exponential survival distribution."||0.77|0.55|<0.0001
70864582|NCT02664610|141214764|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.60
70864583|NCT02664610|141214765|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.79
70864584|NCT04981392|141214769|SUPERIORITY||Cox Proportional Hazard|0.49|STANDARD_ERROR_OF_MEAN|0.18||0.0066|TWO_SIDED||||||Difference in adjusted % vaccinated|||||||0.0066
70864585|NCT04981392|141214770|SUPERIORITY||Cox Proportional Hazard|0.83|STANDARD_ERROR_OF_MEAN|0.3||0.0058|TWO_SIDED||||||Difference in adjusted % vaccinated|||||||0.0058
70864586|NCT01385371|141214805|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.98|||<|0.001||95.0|-1.2|-0.4|||Wilcoxon Rank Sum Test|||||-0.4|-1.2|<0.001
70864587|NCT01385371|141214806|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.64||||0.001|TWO_SIDED|95.0|-0.7|-0.2|||Wilcoxon Rank Sum Test|||||-0.2|-0.7|0.001
70864588|NCT01385371|141214807|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.33|||<|0.001|TWO_SIDED|95.0|-1.4|-0.5|||Wilcoxon Rank Sum Test|||||-0.5|-1.4|<0.001
70864589|NCT01385371|141214808|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.13||||0.027||95.0|-0.2|0.0|||Wilcoxon Rank Sum Test|||||0.0|-0.2|0.027
70864590|NCT01385371|141214809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.0003|TWO_SIDED|95.0|-0.73|-0.22||A zero-inflated log-normal mixed distribution model was used with treatment, baseline asthma status, age category (\<18 or \>=18 years) and pollen region as covariates.|Zero-Inflated Log-Normal Model|||||-0.22|-0.73|0.0003
70864591|NCT01385371|141214810|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.69|||<|0.001|TWO_SIDED|95.0|-0.9|-0.2|||Wilcoxon Rank Sum Test|||||-0.2|-0.9|<0.001
70864592|NCT01385371|141214811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.0001|TWO_SIDED|95.0|-0.94|-0.31||A zero-inflated log-normal mixed distribution model was used with treatment, baseline asthma status, age category (\<18 or \>=18 years) and pollen region as covariates.|Zero-Inflated Log-Normal Model|||||-0.31|-0.94|0.0001
70864593|NCT01385371|141214812|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.15||||0.644|TWO_SIDED|95.0|-0.4|0.6|||Wilcoxon Rank Sum Test|||||0.6|-0.4|0.644
70864594|NCT01346969|141214819|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.38||1|TWO_SIDED|95.0|-0.8|0.8|||Mixed Models Analysis|||Overall Opinion: Intraparticipant analysis||0.8|-0.8|1.000
70864595|NCT01346969|141214819|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.37||1|TWO_SIDED|95.0|-0.7|0.7|||Mixed Models Analysis|||Vascularity: Intraparticipant analysis||0.7|-0.7|1.000
70864596|NCT01346969|141214819|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.3|STANDARD_ERROR_OF_MEAN|0.36||0.391|TWO_SIDED|95.0|-1.0|0.4|||Mixed Models Analysis|||Pigmentation: Intraparticipant analysis||0.4|-1.0|0.391
70864597|NCT01346969|141214819|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.39||0.696|TWO_SIDED|95.0|-0.6|0.9|||Mixed Models Analysis|||Thickness: Intraparticipant analysis||0.9|-0.6|0.696
70864598|NCT01346969|141214819|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.39||0.921|TWO_SIDED|95.0|-0.7|0.8|||Mixed Models Analysis|||Relief: Intraparticipant analysis||0.8|-0.7|0.921
70864599|NCT01346969|141214819|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.39||0.693|TWO_SIDED|95.0|-0.6|0.9|||Mixed Models Analysis|||Pliability: Intraparticipant analysis||0.9|-0.6|0.693
70864600|NCT01346969|141214819|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.39||0.77|TWO_SIDED|95.0|-0.7|0.9|||Mixed Models Analysis|||Surface Area: Intraparticipant analysis||0.9|-0.7|0.770
70948085|NCT00267098|141397000|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|0.041|||||TWO_SIDED|95.0|-0.136|0.22||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in E/A through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean E/A change through 18 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in E:A ratio (E/A) through 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in E:A ratio through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value.||0.220|-0.136|
70864601|NCT01346969|141214819|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|1.98||0.938|TWO_SIDED|95.0|-3.7|4.0|||Mixed Models Analysis|||Composite Score: Intraparticipant analysis||4.0|-3.7|0.938
71139101|NCT01506271|141778010|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-4.4|||||TWO_SIDED|95.0|-10.7|0.7|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Resp. \& chest||0.7|-10.7|
70864602|NCT01346969|141214819|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|0.52||0.34|TWO_SIDED|95.0|-1.5|0.5|||Mixed Models Analysis|||Overall Opinion: Intraparticipant analysis||0.5|-1.5|0.340
70864603|NCT01346969|141214819|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|0.5||0.258|TWO_SIDED|95.0|-1.6|0.4|||Mixed Models Analysis|||Vascularity: Intraparticipant analysis||0.4|-1.6|0.258
70864604|NCT01346969|141214819|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.49||0.381|TWO_SIDED|95.0|-1.4|0.5|||Mixed Models Analysis|||Pigmentation: Intraparticipant analysis||0.5|-1.4|0.381
70864605|NCT01346969|141214819|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|0.54||0.287|TWO_SIDED|95.0|-1.6|0.5|||Mixed Models Analysis|||Thickness: Intraparticipant analysis||0.5|-1.6|0.287
70864606|NCT01346969|141214819|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.53||0.42|TWO_SIDED|95.0|-1.5|0.6|||Mixed Models Analysis|||Relief: Intraparticipant analysis||0.6|-1.5|0.420
70864607|NCT01346969|141214819|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|0.53||0.227|TWO_SIDED|95.0|-1.7|0.4|||Mixed Models Analysis|||Pliability: Intraparticipant analysis||0.4|-1.7|0.227
70864608|NCT01346969|141214819|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.54||0.427|TWO_SIDED|95.0|-1.5|0.6|||Mixed Models Analysis|||Surface Area: Intraparticipant analysis||0.6|-1.5|0.427
70864609|NCT01346969|141214819|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-3.1|STANDARD_ERROR_OF_MEAN|2.7||0.256|TWO_SIDED|95.0|-8.4|2.2|||Mixed Models Analysis|||Composite Score: Intraparticipant analysis||2.2|-8.4|0.256
70864610|NCT01346969|141214819|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.8|STANDARD_ERROR_OF_MEAN|0.62||0.198|TWO_SIDED|95.0|-0.4|2.0|||Mixed Models Analysis|||Overall Opinion: Intraparticipant analysis||2.0|-0.4|0.198
70864611|NCT01346969|141214819|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.9|STANDARD_ERROR_OF_MEAN|0.6||0.132|TWO_SIDED|95.0|-0.3|2.1|||Mixed Models Analysis|||Vascularity: Intraparticipant analysis||2.1|-0.3|0.132
70864612|NCT01346969|141214819|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.7|STANDARD_ERROR_OF_MEAN|0.58||0.227|TWO_SIDED|95.0|-0.4|1.8|||Mixed Models Analysis|||Pigmentation: Intraparticipant analysis||1.8|-0.4|0.227
70864613|NCT01346969|141214819|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.8|STANDARD_ERROR_OF_MEAN|0.63||0.208|TWO_SIDED|95.0|-0.4|2.0|||Mixed Models Analysis|||Thickness: Intraparticipant analysis||2.0|-0.4|0.208
70864614|NCT01346969|141214819|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.7|STANDARD_ERROR_OF_MEAN|0.63||0.265|TWO_SIDED|95.0|-0.5|1.9|||Mixed Models Analysis|||Relief: Intraparticipant analysis||1.9|-0.5|0.265
70864615|NCT01346969|141214819|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|0.63||0.34|TWO_SIDED|95.0|-0.6|1.8|||Mixed Models Analysis|||Pliability: Intraparticipant analysis||1.8|-0.6|0.340
70864616|NCT01346969|141214819|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|0.64||0.347|TWO_SIDED|95.0|-0.7|1.9|||Mixed Models Analysis|||Surface Area: Intraparticipant analysis||1.9|-0.7|0.347
70864617|NCT01346969|141214819|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|4.3|STANDARD_ERROR_OF_MEAN|3.19||0.179|TWO_SIDED|95.0|-2.0|10.6|||Mixed Models Analysis|||Composite Score: Intraparticipant analysis||10.6|-2.0|0.179
70864618|NCT01346969|141214819|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|Least Square (LS) Mean|-0.3|STANDARD_ERROR_OF_MEAN|0.57||0.556|TWO_SIDED|95.0|-1.4|0.8|||Mixed Models Analysis|||Overall Opinion: Intraparticipant analysis||0.8|-1.4|0.556
70864619|NCT01346969|141214819|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.54||0.76|TWO_SIDED|95.0|-1.2|0.9|||Mixed Models Analysis|||Vascularity: Intraparticipant analysis||0.9|-1.2|0.760
70864620|NCT01346969|141214819|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.3|STANDARD_ERROR_OF_MEAN|0.53||0.636|TWO_SIDED|95.0|-1.3|0.8|||Mixed Models Analysis|||Pigmentation: Intraparticipant analysis||0.8|-1.3|0.636
70864621|NCT01346969|141214819|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.58||0.774|TWO_SIDED|95.0|-1.3|1.0|||Mixed Models Analysis|||Thickness: Intraparticipant analysis||1.0|-1.3|0.774
70864622|NCT01346969|141214819|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.57||0.771|TWO_SIDED|95.0|-1.3|1.0|||Mixed Models Analysis|||Relief: Intraparticipant analysis||1.0|-1.3|0.771
70864623|NCT01346969|141214819|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.57||0.468|TWO_SIDED|95.0|-1.5|0.7|||Mixed Models Analysis|||Pliability: Intraparticipant analysis||0.7|-1.5|0.468
71139102|NCT01506271|141778010|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-8.4|4.4|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Resp. \& chest||4.4|-8.4|
71139103|NCT01506271|141778010|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|2.5|||||TWO_SIDED|95.0|-2.4|8.1|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Skin \& subcutan.||8.1|-2.4|
71139104|NCT01506271|141778010|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.0|||||TWO_SIDED|95.0|-4.7|4.5|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Skin \& subcutan.||4.5|-4.7|
71139105|NCT01506271|141778010|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-3.6|||||TWO_SIDED|95.0|-9.9|2.0|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Vascular disorders||2.0|-9.9|
71139106|NCT01506271|141778010|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.1|||||TWO_SIDED|95.0|-6.9|6.6|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Vascular disorders||6.6|-6.9|
71139107|NCT03040141|141778011|SUPERIORITY|The null hypothesis was defined as no treatment difference.|Odds Ratio (OR)|1.9||||0.181|TWO_SIDED|95.0|1.03|13.55|||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||13.55|1.03|0.181
71139108|NCT03040141|141778011|SUPERIORITY|The null hypothesis was defined as no treatment difference.|Odds Ratio (OR)|3.3||||0.073|TWO_SIDED|95.0|0.9|12.13|||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||12.13|0.90|0.073
71139109|NCT03040141|141778011|SUPERIORITY|The null hypothesis was defined as no treatment difference.|Odds Ratio (OR)|3.5||||0.037|TWO_SIDED|95.0|1.08|11.48|||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||11.48|1.08|0.037
71139110|NCT03040141|141778011|SUPERIORITY|The null hypothesis was defined as no treatment difference.|Odds Ratio (OR)|1.1||||0.814|TWO_SIDED|95.0|0.4|3.25|||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||3.25|0.40|0.814
71139111|NCT03040141|141778013|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.748||||||p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level. The goal will be used to assess the strength of evidence to select the endpoints for a Phase 3 trial.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The VIS410 high-dose group was compared against the placebo group. The null hypothesis was defined as no treatment difference.||||0.748
71139112|NCT03040141|141778013|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.94||||||p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The VIS410 low-dose group was compared against the placebo group. The null hypothesis was defined as no treatment difference||||0.940
71139113|NCT03040141|141778013|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.902||||||p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The total VIS410 high-dose group (high-dose + low-dose) was compared against the placebo group. The null hypothesis was defined as no treatment difference.||||0.902
71139114|NCT03040141|141778013|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.283||||||p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The VIS410 high-dose group was compared against the VIS410 low-dose group. The null hypothesis was defined as no treatment difference.||||0.283
71139115|NCT03040141|141778014|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.919||||||p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The VIS410 high-dose group was compared against the placebo group. The null hypothesis was defined as no treatment difference.||||0.919
71139116|NCT03040141|141778014|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.9||||||p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The VIS410 low-dose group was compared against the placebo group. The null hypothesis was defined as no treatment difference.||||0.900
71139117|NCT03040141|141778014|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.99||||||p-value is not adjusted for multiple comparisons|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level||The combined VIS410 high- and low-dose groups was compared against the placebo group. The null hypothesis was defined as no treatment difference.||||0.990
71139118|NCT03040141|141778014|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.521||||||The p-value is not adjusted for multiple comparisons.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The VIS410 high-dose group was compared against the VIS410 low-dose group. The null hypothesis was defined as no treatment difference.||||0.521
71139119|NCT03040141|141778015|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.36||||||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.|ANOVA|||The VIS410 high-dose group was compared against the placebo group. The null hypothesis was defined as no treatment difference.||||0.360
71139120|NCT03040141|141778016|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.735|||||||ANOVA|||||||0.735
71139121|NCT03040141|141778016|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.259|||||||ANOVA|||||||0.259
71139122|NCT03040141|141778016|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.644||||||The p-value is not adjusted for multiple comparisons. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.|ANOVA|||||||0.644
71139123|NCT03040141|141778016|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.146|||||||ANOVA|||||||0.146
70864624|NCT01346969|141214819|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.58||0.886|TWO_SIDED|95.0|-1.2|1.1|||Mixed Models Analysis|||Surface Area: Intraparticipant analysis||1.1|-1.2|0.886
70864625|NCT01346969|141214819|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-1.3|STANDARD_ERROR_OF_MEAN|2.91||0.668|TWO_SIDED|95.0|-7.0|4.5|||Mixed Models Analysis|||Composite Score: Intraparticipant analysis||4.5|-7.0|0.668
70864626|NCT01881373|141214825|SUPERIORITY|Hierarchical logistic model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-3.88||||0.02|TWO_SIDED|95.0|-7.29|-0.47|||Regression, Logistic|Hierarchical model.|Intervention vs control communities comparing 24 months to baseline|||-0.47|-7.29|0.02
70864627|NCT01881373|141214825|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|-2.63||||0.28|TWO_SIDED|95.0|-8.58|3.32||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Logistic|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||3.32|-8.58|0.28
70864628|NCT01881373|141214826|SUPERIORITY|Hierarchical model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-1.64||||0.009|TWO_SIDED|95.0|-2.87|-0.41||Intervention vs control communities comparing 78 months to baseline.|Regression, Linear|Hierarchical model.||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||-0.41|-2.87|0.009
70864629|NCT01881373|141214826|SUPERIORITY|Hierarchical logistic model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|4.35||||0.49|TWO_SIDED|95.0|-8.5|17.24|||Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs temporal comparing 78 months to baseline.||17.24|-8.5|0.49
70948086|NCT00267098|141397001|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|0.11|||||TWO_SIDED|95.0|-0.085|0.311||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in E/A through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean E/A change through 24 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in E:A ratio (E/A) through 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in E:A ratio through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value.||0.311|-0.085|
70948087|NCT00267098|141397002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1841||||0.9985||95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, was calculated. A probability ≥ 0.95 was significant.|Posterior probability of mean difference|The posterior probability that the mean difference is greater than 0 was calculated.|This was a one-sided analysis of the BiV arm - RV arm difference in Mean Clinical Composite Scores. Values above 0 suggested better outcomes in the Biventricular arm.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar Clinical Composite Scores after 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients had better scores with BiV pacing than RV pacing. The analysis assigned numerical values (Improved=3, Unchanged=2, Worsened=1) and compared the average score between randomization arms using a one-sided analysis.||||0.9985
71139124|NCT03040141|141778017|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.624||||||The p-value is not adjusted for multiple comparisons. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.|ANOVA|||||||0.624
71139125|NCT03040141|141778017|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.399||||||The p-value is not adjusted for multiple comparisons. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.|ANOVA|||||||0.399
71139126|NCT03040141|141778017|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.837|||||||ANOVA|||||||0.837
71139127|NCT03040141|141778017|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.183|||||||ANOVA|||||||0.183
71139128|NCT03040141|141778018|SUPERIORITY|The null hypothesis was defined as no treatment difference||||||0.88|||||||ANOVA|||||||0.880
71139129|NCT03040141|141778018|SUPERIORITY|The null hypothesis was defined as no treatment difference||||||0.778|||||||ANOVA|||||||0.778
71139130|NCT03040141|141778018|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.94|||||||ANOVA|||||||0.940
71139131|NCT03040141|141778018|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.662|||||||ANOVA|||||||0.662
71139132|NCT03040141|141778019|OTHER|||||||0.64|||||||Chi-squared|A Wald Chi-square statistic from a Cox proportional model was used for comparisons of treatment groups||||||0.640
71139133|NCT03040141|141778019|OTHER|||||||0.775|||||||Chi-squared|A Wald Chi-square statistic from a Cox proportional model was used for comparisons of treatment groups||||||0.775
71139134|NCT03040141|141778019|OTHER|||||||0.701|||||||Chi-squared|A Wald Chi-square statistic from a Cox proportional model was used for comparisons of treatment groups||||||0.701
70864630|NCT01881373|141214827|SUPERIORITY|Hierarchical logistic model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Difference in prevalence|-3.6|||<|0.01|TWO_SIDED||||||Regression, Logistic|Hierarchical model||Intervention vs control comparing 24 months to baseline.||||<0.01
70864631|NCT01881373|141214828|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|change in prevalence between communities|-12.6||||0.003|TWO_SIDED|95.0|-20.92|-4.28||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Logistic|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Intervention vs. control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||-4.28|-20.92|0.003
70864632|NCT01881373|141214828|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|-3.43||||0.33|TWO_SIDED|95.0|-10.36|3.5||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Logistic|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs. Temporal communities. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||3.50|-10.36|0.33
70864633|NCT01881373|141214829|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|-0.71||||0.02|TWO_SIDED|95.0|-1.37|-0.05||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||-0.05|-1.37|0.02
70864634|NCT01881373|141214829|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|-0.65||||0.13|TWO_SIDED|95.0|-1.79|0.49||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||0.49|-1.79|0.13
70864635|NCT01881373|141214830|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.01||||0.86|TWO_SIDED||||||Regression, Linear|Hierarchical model.||Intervention vs control comparing 24 months to baseline.||||0.86
70864636|NCT01881373|141214831|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-1.17||||0.68|TWO_SIDED||||||Regression, Linear|||Intervention vs control comparing 24 months to baseline.||||0.68
70864637|NCT01881373|141214832|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|3.42||||0.55|TWO_SIDED||||||Regression, Linear|||Intervention vs control comparing 24 months to baseline.||||0.55
71139135|NCT03040141|141778019|OTHER|||||||0.638|||||||Chi-squared|A Wald Chi-square statistic from a Cox proportional model was used for comparisons of treatment groups||||||0.638
71139136|NCT03040141|141778020|OTHER|||||||0.127|||||||Regression, Logistic|||||||0.127
70864638|NCT01881373|141214833|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.5||||0.11|TWO_SIDED||||||Regression, Linear|||Intervention vs control comparing 24 months to baseline.||||0.11
71139137|NCT03040141|141778020|OTHER|||||||1|||||||Regression, Logistic|||||||1.000
71139138|NCT03040141|141778020|OTHER|||||||0.458|||||||Regression, Logistic|||||||0.458
71139139|NCT03040141|141778020|OTHER|||||||0.127|||||||Regression, Logistic|||||||0.127
71139140|NCT03040141|141778021|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.371|||||||ANOVA|||||||0.371
71139141|NCT03040141|141778021|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.735|||||||ANOVA|||||||0.735
71139142|NCT03040141|141778021|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.476|||||||ANOVA|||||||0.476
71139143|NCT03040141|141778021|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.581|||||||ANOVA|||||||0.581
71139144|NCT03040141|141778022|OTHER|||||||0.98|||||||Regression, Logistic|||||||0.980
71139145|NCT03040141|141778022|OTHER|||||||0.955|||||||Regression, Logistic|||||||0.955
71139146|NCT03040141|141778022|OTHER|||||||0.955|||||||Regression, Logistic|||||||0.955
71139147|NCT03040141|141778022|OTHER|||||||0.955|||||||Regression, Logistic|||||||0.955
71139148|NCT03040141|141778023|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.695|||||||ANOVA|||||||0.695
71139149|NCT03040141|141778023|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.542|||||||ANOVA|||||||0.542
71139150|NCT03040141|141778023|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.899|||||||ANOVA|||||||0.899
71139151|NCT03040141|141778023|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.321|||||||ANOVA|||||||0.321
71139152|NCT03040141|141778024|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.663|||||||ANOVA|||||||0.663
71139153|NCT03040141|141778024|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.54|||||||ANOVA|||||||0.540
71139154|NCT03040141|141778024|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.918|||||||ANOVA|||||||0.918
71139155|NCT03040141|141778024|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.294|||||||ANOVA|||||||0.294
71139156|NCT03040141|141778026|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.25|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.250
71139157|NCT03040141|141778026|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.133|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.133
71139158|NCT03040141|141778026|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.177|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||||||0.177
71139159|NCT03040141|141778026|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.36|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons||||0.360
71139160|NCT03040141|141778027|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.636|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.636
71139161|NCT03040141|141778027|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.446|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||||||0.446
71139162|NCT03040141|141778027|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.53|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.530
71139163|NCT03040141|141778027|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.463|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.463
71139164|NCT03040141|141778028|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.152|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.152
71139165|NCT03040141|141778028|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.176|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.176
71139166|NCT03040141|141778028|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.157|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.157
71139167|NCT03040141|141778028|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.844|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||||||0.844
71139168|NCT03040141|141778029|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.531|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.531
71139169|NCT03040141|141778029|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.582|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.582
71139170|NCT03040141|141778029|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.55|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.550
71139171|NCT03040141|141778029|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.84|||||||Chi-squared|P-value determined based on Cox proportional hazards model Wald Chi-Square Statistic.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.840
71139172|NCT03040141|141778030|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.3534|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.3534
71139173|NCT03040141|141778030|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.7839|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.7839
71139174|NCT03040141|141778030|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.4893|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.4893
70864639|NCT01881373|141214834|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.7||||0.08|TWO_SIDED||||||Regression, Linear|||mixed model adjusting for age and sex and cluster of community and strata of jurisdiction; intervention vs control comparing 24 months to baseline||||0.08
71139175|NCT03040141|141778030|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.5101|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.5101
71139176|NCT03040141|141778031|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.5436|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.5436
71139177|NCT03040141|141778031|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.8215|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.8215
71139178|NCT03040141|141778031|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.6319|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.6319
71139179|NCT03040141|141778031|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.7011|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.7011
71139180|NCT03040141|141778032|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.478|||||||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.478
71139181|NCT03040141|141778032|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.468|||||||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.468
71139182|NCT03040141|141778032|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.412|||||||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons||||0.412
71139183|NCT03040141|141778032|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.982|||||||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons||||0.982
71139184|NCT03515824|141778056|OTHER|Bayesian posterior credible interval|Pooled-adjacent-violator algorithm|0.0|||||TWO_SIDED|80.0|0.0|33.1||||||||33.1|0.0|
71139185|NCT03515824|141778056|OTHER|Bayesian posterior credible interval|Pooled-adjacent-violator algorithm|0.0|||||TWO_SIDED|80.0|0.0|33.1||||||||33.1|0.0|
71139186|NCT03515824|141778056|OTHER|Bayesian posterior credible interval|Pooled-adjacent-violator algorithm|15.4|||||TWO_SIDED|80.0|5.8|30.2||||||||30.2|5.8|
71139187|NCT03515824|141778059|OTHER|Clopper Pearson confidence interval method for binomial data|Objective Response Rate (ORR)|0.0|||||TWO_SIDED|95.0|0.0|70.8||||||||70.8|0.0|
71139188|NCT03515824|141778059|OTHER|Clopper Pearson confidence interval method for binomial data|Objective Response Rate (ORR)|0.0|||||TWO_SIDED|95.0|0.0|60.2||||||||60.2|0.0|
71139189|NCT03515824|141778059|OTHER|Clopper Pearson confidence interval method for binomial data|Objective Response Rate (ORR)|0.0|||||TWO_SIDED|95.0|0.0|21.8||||||||21.8|0.0|
71139190|NCT03515824|141778060|OTHER|Clopper Pearson confidence interval method for binomial data|Objective Response Rate (ORR)|0.0|||||TWO_SIDED|95.0|0.0|84.2||||||||84.2|0.0|
71139191|NCT03515824|141778060|OTHER|Clopper Pearson confidence interval method for binomial data|Objective Response Rate (ORR)|0.0|||||TWO_SIDED|95.0|0.0|70.8||||||||70.8|0.0|
71139192|NCT03515824|141778060|OTHER|Clopper Pearson confidence interval method for binomial data|Objective Response Rate )ORR)|0.0|||||TWO_SIDED|95.0|0.0|28.5||||||||28.5|0.0|
71139193|NCT00539994|141778097|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71139194|NCT00539994|141778097|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71139195|NCT03071263|141778106|SUPERIORITY||||||<|0.0001||||||α-level 0.05. Stratified by baseline potassium category (4.3-\<4.7 mEq/L or 4.7-5.1 mEq/L) and history of Type 1 or Type 2 diabetes mellitus (Yes or No) as randomized|Cochran-Mantel-Haenszel|||A sample size of 280 subjects has 90% power to detect a difference between treatment groups of 20% or more in the proportion of subjects remaining on spironolactone at Week 12, at α = 0.05.||||<0.0001
71139196|NCT03071263|141778107|SUPERIORITY|||||||0.5757||||||Baseline AOBP SBP as a covariate and treatment group, baseline serum potassium (K+ 4.3-\<4.7 or 4.7-5.1 mEq/L), and history of Type 1 or Type 2 diabetes mellitus (Yes or No) as factors in the model.|ANCOVA|||||||0.5757
71139197|NCT03071263|141778108|SUPERIORITY|||||||0.6367||||||Baseline AOBP SBP as a covariate and treatment group, baseline serum potassium (K+ 4.3-\<4.7 or 4.7-5.1 mEq/L), and history of Type 1 or Type 2 diabetes mellitus as factors in the model.|ANCOVA|||The p-value is from a test comparing the difference between two groups in the mean change in AOBP SBP from baseline.||||0.6367
71139198|NCT03084796|141778116|SUPERIORITY||Mean Difference (Final Values)|0.068||||0.037|TWO_SIDED|95.0|0.003|0.132|||Mixed Models Analysis|||"Comparison groups were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates.~Adjusted for multiplicity based on the parametric simulation method by Edwards and Berry."||0.132|0.003|0.037
71139199|NCT03084796|141778116|SUPERIORITY||Mean Difference (Final Values)|0.116|||<|0.001|TWO_SIDED|95.0|0.051|0.181|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis for was performed as described for the statistical analysis 1 for this outcome measure.~Adjusted for multiplicity based on the parametric simulation method by Edwards and Berry."||0.181|0.051|<0.001
71139200|NCT03084796|141778116|SUPERIORITY||Mean Difference (Final Values)|0.151|||<|0.001|TWO_SIDED|95.0|0.086|0.216|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis for was performed as described for the statistical analysis 1 for this outcome measure.~Adjusted for multiplicity based on the parametric simulation method by Edwards and Berry."||0.216|0.086|<0.001
70864640|NCT01881373|141214835|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.04||||0.71|TWO_SIDED||||||Regression, Linear|Hierarchical model.||Intervention vs control comparing 24 months to baseline.||||0.71
70864641|NCT01881373|141214836|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.02||||0.54|TWO_SIDED||||||Regression, Linear|Hierarchical model.||Intervention vs control comparing 24 months to baseline.||||0.54
70864642|NCT01881373|141214837|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.01||||0.9|TWO_SIDED||||||Regression, Linear|||Intervention vs control comparing 24 months to baseline.||||0.90
70864643|NCT01881373|141214838|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.05||||0.71|TWO_SIDED||||||Regression, Linear|||Intervention vs control comparing 24 months to baseline.||||0.71
70864644|NCT01881373|141214839|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.18||||0.48|TWO_SIDED|||||intervention vs control communities|Regression, Linear|||Intervention vs control comparing 24 months to baseline.||||0.48
70864645|NCT01881373|141214840|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|differences in prevalence|-3.6|||<|0.01|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Logistic|Hierarchical model||intervention vs control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||<0.01
70864646|NCT01881373|141214841|SUPERIORITY|Hierarchical|Mean Difference (Final Values)|0.09||||0.44|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs Control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.44
71139201|NCT03084796|141778116|SUPERIORITY||Mean Difference (Final Values)|0.145|||<|0.001|TWO_SIDED|95.0|0.081|0.209|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis for was performed as described for the statistical analysis 1 for this outcome measure.~Adjusted for multiplicity based on the parametric simulation method by Edwards and Berry."||0.209|0.081|<0.001
71139202|NCT03084796|141778116|SUPERIORITY||Mean Difference (Final Values)|0.211|||<|0.001|TWO_SIDED|95.0|0.159|0.263|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.263|0.159|<0.001
71139203|NCT03084796|141778116|SUPERIORITY||Mean Difference (Final Values)|0.048||||0.066|TWO_SIDED|95.0|-0.003|0.1|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.100|-0.003|0.066
71139204|NCT03084796|141778116|SUPERIORITY||Mean Difference (Final Values)|0.083||||0.002|TWO_SIDED|95.0|0.031|0.135|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.135|0.031|0.002
71139205|NCT03084796|141778116|SUPERIORITY||Mean Difference (Final Values)|0.077||||0.003|TWO_SIDED|95.0|0.026|0.128|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.128|0.026|0.003
71139206|NCT03084796|141778116|SUPERIORITY||Mean Difference (Final Values)|0.035||||0.189|TWO_SIDED|95.0|-0.017|0.087|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD.~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.087|-0.017|0.189
71139207|NCT03084796|141778116|SUPERIORITY||Mean Difference (Final Values)|0.029||||0.273|TWO_SIDED|95.0|-0.023|0.08|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.080|-0.023|0.273
70864647|NCT01881373|141214842|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.16||||0.81|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs. Control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.81
70864648|NCT01881373|141214843|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.37||||0.68|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.68
70948088|NCT00267098|141397003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2503||||0.9999||95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, was calculated. A probability ≥ 0.95 was significant.|Posterior probability of mean difference|The posterior probability that the mean difference is greater than 0 was calculated.|This was a one-sided analysis of the BiV arm - RV arm difference in Mean Clinical Composite Scores. Values above 0 suggested better outcomes in the Biventricular arm.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar Clinical Composite Scores after 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients had better scores with BiV pacing than RV pacing. The analysis assigned numerical values (Improved=3, Unchanged=2, Worsened=1) and compared the average score between randomization arms using a one-sided analysis.||||0.9999
71139208|NCT03084796|141778116|SUPERIORITY||Mean Difference (Final Values)|-0.006||||0.813|TWO_SIDED|95.0|-0.058|0.045|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.045|-0.058|0.813
71139209|NCT03084796|141778117|SUPERIORITY||Mean Difference (Final Values)|0.059||||0.002|TWO_SIDED|95.0|0.022|0.095|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model for repeated measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.095|0.022|0.002
71139210|NCT03084796|141778117|SUPERIORITY||Mean Difference (Final Values)|0.077|||<|0.001|TWO_SIDED|95.0|0.04|0.113|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.113|0.040|<0.001
71139211|NCT03084796|141778117|SUPERIORITY||Mean Difference (Final Values)|0.126|||<|0.001|TWO_SIDED|95.0|0.089|0.163|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.163|0.089|<0.001
70864649|NCT01881373|141214844|SUPERIORITY|Hierarchical model. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.02||||0.69|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.69
70864650|NCT01881373|141214845|SUPERIORITY|Hierarchical model. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.21||||0.11|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Intervention vs. control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.11
71139212|NCT03084796|141778117|SUPERIORITY||Mean Difference (Final Values)|0.14|||<|0.001|TWO_SIDED|95.0|0.104|0.177|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.177|0.104|<0.001
71139213|NCT03084796|141778117|SUPERIORITY||Mean Difference (Final Values)|0.183|||<|0.001|TWO_SIDED|95.0|0.147|0.22|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.220|0.147|<0.001
71139214|NCT03084796|141778117|SUPERIORITY||Mean Difference (Final Values)|0.018||||0.322|TWO_SIDED|95.0|-0.018|0.055|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.055|-0.018|0.322
71139215|NCT03084796|141778117|SUPERIORITY||Mean Difference (Final Values)|0.067|||<|0.001|TWO_SIDED|95.0|0.031|0.104|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.104|0.031|<0.001
70948089|NCT00267098|141397004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1978||||0.9978||95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, was calculated. A probability ≥ 0.95 was significant.|Posterior probability of mean difference|The posterior probability that the mean difference is greater than 0 was calculated.|This was a one-sided analysis of the BiV arm - RV arm difference in Mean Clinical Composite Scores. Values above 0 suggested better outcomes in the Biventricular arm.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar Clinical Composite Scores after 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients had better scores with BiV pacing than RV pacing. The analysis assigned numerical values (Improved=3, Unchanged=2, Worsened=1) and compared the average score between randomization arms using a one-sided analysis.||||0.9978
70948090|NCT00267098|141397005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2069||||0.9983||95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, was calculated. A probability ≥ 0.95 was significant.|Posterior probability of mean difference|The posterior probability that the mean difference is greater than 0 was calculated.|This was a one-sided analysis of the BiV arm - RV arm difference in Mean Clinical Composite Scores. Values above 0 suggested better outcomes in the Biventricular arm.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar Clinical Composite Scores after 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients had better scores with BiV pacing than RV pacing. The analysis assigned numerical values (Improved=3, Unchanged=2, Worsened=1) and compared the average score between randomization arms using a one-sided analysis.||||0.9983
71139216|NCT03084796|141778117|SUPERIORITY||Mean Difference (Final Values)|0.082|||<|0.001|TWO_SIDED|95.0|0.045|0.118|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.118|0.045|<0.001
71139217|NCT03084796|141778117|SUPERIORITY||Mean Difference (Final Values)|0.049||||0.008|TWO_SIDED|95.0|0.013|0.086|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD.~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.086|0.013|0.008
71139218|NCT03084796|141778117|SUPERIORITY||Mean Difference (Final Values)|0.063|||<|0.001|TWO_SIDED|95.0|0.027|0.1|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.100|0.027|<0.001
71139219|NCT03084796|141778117|SUPERIORITY||Mean Difference (Final Values)|0.014||||0.443|TWO_SIDED|95.0|-0.022|0.051|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.051|-0.022|0.443
71139220|NCT03084796|141778118|SUPERIORITY||Mean Difference (Final Values)|0.072|||<|0.001|TWO_SIDED|95.0|0.038|0.105|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model for repeated measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.105|0.038|<0.001
71139221|NCT03084796|141778118|SUPERIORITY||Mean Difference (Final Values)|0.086|||<|0.001|TWO_SIDED|95.0|0.052|0.119|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.119|0.052|<0.001
71139222|NCT03084796|141778118|SUPERIORITY||Mean Difference (Final Values)|0.143|||<|0.001|TWO_SIDED|95.0|0.109|0.177|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.177|0.109|<0.001
71139223|NCT03084796|141778118|SUPERIORITY||Mean Difference (Final Values)|0.16|||<|0.001|TWO_SIDED|95.0|0.127|0.194|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.194|0.127|<0.001
71139224|NCT03084796|141778118|SUPERIORITY||Mean Difference (Final Values)|0.164|||<|0.001|TWO_SIDED|95.0|0.131|0.198|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.198|0.131|<0.001
71139225|NCT03084796|141778118|SUPERIORITY||Mean Difference (Final Values)|0.014||||0.418|TWO_SIDED|95.0|-0.02|0.048|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.048|-0.020|0.418
71139226|NCT03084796|141778118|SUPERIORITY||Mean Difference (Final Values)|0.071|||<|0.001|TWO_SIDED|95.0|0.038|0.105|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.105|0.038|<0.001
71139227|NCT03084796|141778118|SUPERIORITY||Mean Difference (Final Values)|0.089|||<|0.001|TWO_SIDED|95.0|0.055|0.122|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.122|0.055|<0.001
71139228|NCT03084796|141778118|SUPERIORITY||Mean Difference (Final Values)|0.057|||<|0.001|TWO_SIDED|95.0|0.024|0.091|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.091|0.024|<0.001
71139229|NCT03084796|141778118|SUPERIORITY||Mean Difference (Final Values)|0.075|||<|0.001|TWO_SIDED|95.0|0.041|0.108|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.108|0.041|<0.001
71139230|NCT03084796|141778118|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.308|TWO_SIDED|95.0|-0.016|0.051|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.051|-0.016|0.308
71139231|NCT03084796|141778118|SUPERIORITY||Mean Difference (Final Values)|0.092|||<|0.001|TWO_SIDED|95.0|0.038|0.147|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.147|0.038|<0.001
71139232|NCT03084796|141778118|SUPERIORITY||Mean Difference (Final Values)|0.133|||<|0.001|TWO_SIDED|95.0|0.079|0.188|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Analyzed, using linear mixed model repeated measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.188|0.079|<0.001
71139233|NCT03084796|141778118|SUPERIORITY||Mean Difference (Final Values)|0.174|||<|0.001|TWO_SIDED|95.0|0.12|0.229|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.229|0.120|<0.001
71139234|NCT03084796|141778118|SUPERIORITY||Mean Difference (Final Values)|0.181|||<|0.001|TWO_SIDED|95.0|0.127|0.235|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.235|0.127|<0.001
71139235|NCT03084796|141778118|SUPERIORITY||Mean Difference (Final Values)|0.229|||<|0.001|TWO_SIDED|95.0|0.175|0.284|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.284|0.175|<0.001
71139236|NCT03084796|141778118|SUPERIORITY||Mean Difference (Final Values)|0.041||||0.141|TWO_SIDED|95.0|-0.013|0.095|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.095|-0.013|0.141
71139237|NCT03084796|141778118|SUPERIORITY||Mean Difference (Final Values)|0.082||||0.003|TWO_SIDED|95.0|0.028|0.137|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.137|0.028|0.003
71139238|NCT03084796|141778118|SUPERIORITY||Mean Difference (Final Values)|0.088||||0.001|TWO_SIDED|95.0|0.035|0.142|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.142|0.035|0.001
71139239|NCT03084796|141778118|SUPERIORITY||Mean Difference (Final Values)|0.041||||0.137|TWO_SIDED|95.0|-0.013|0.096|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.096|-0.013|0.137
71139240|NCT03084796|141778118|SUPERIORITY||Mean Difference (Final Values)|0.048||||0.082|TWO_SIDED|95.0|-0.006|0.101|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.101|-0.006|0.082
71139241|NCT03084796|141778118|SUPERIORITY||Mean Difference (Final Values)|0.006||||0.823|TWO_SIDED|95.0|-0.048|0.06|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.060|-0.048|0.823
70864651|NCT01881373|141214846|SUPERIORITY|Hierarchical model. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.06||||0.4|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|||Intervention vs. control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.40
71139242|NCT03084796|141778119|SUPERIORITY||Mean Difference (Final Values)|0.061||||0.002|TWO_SIDED|95.0|0.022|0.1|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.100|0.022|0.002
71139243|NCT03084796|141778119|SUPERIORITY||Mean Difference (Final Values)|0.075|||<|0.001|TWO_SIDED|95.0|0.036|0.113|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.113|0.036|<0.001
71139244|NCT03084796|141778119|SUPERIORITY||Mean Difference (Final Values)|0.124|||<|0.001|TWO_SIDED|95.0|0.085|0.163|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.163|0.085|<0.001
71139245|NCT03084796|141778119|SUPERIORITY||Mean Difference (Final Values)|0.152|||<|0.001|TWO_SIDED|95.0|0.113|0.19|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.190|0.113|<0.001
71139246|NCT03084796|141778119|SUPERIORITY||Mean Difference (Final Values)|0.163|||<|0.001|TWO_SIDED|95.0|0.124|0.202|||MMRM|||"Day 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.202|0.124|<0.001
71139247|NCT03084796|141778119|SUPERIORITY||Mean Difference (Final Values)|0.014||||0.485|TWO_SIDED|95.0|-0.025|0.052|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.052|-0.025|0.485
71139248|NCT03084796|141778119|SUPERIORITY||Mean Difference (Final Values)|0.063||||0.001|TWO_SIDED|95.0|0.025|0.102|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.102|0.025|0.001
71139249|NCT03084796|141778119|SUPERIORITY||Mean Difference (Final Values)|0.091|||<|0.001|TWO_SIDED|95.0|0.053|0.13|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.130|0.053|<0.001
71139250|NCT03084796|141778119|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.012|TWO_SIDED|95.0|0.011|0.088|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.088|0.011|0.012
71139251|NCT03084796|141778119|SUPERIORITY||Mean Difference (Final Values)|0.077|||<|0.001|TWO_SIDED|95.0|0.039|0.116|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.116|0.039|<0.001
71139252|NCT03084796|141778119|SUPERIORITY||Mean Difference (Final Values)|0.028||||0.157|TWO_SIDED|95.0|-0.011|0.066|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.066|-0.011|0.157
70864652|NCT01881373|141214847|SUPERIORITY|Hierarchical model. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.2||||0.37|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.37
70864653|NCT01881373|141214847|SUPERIORITY|Hierarchical model.The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.18||||0.51|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs temporal.The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.51
70864654|NCT01686828|141214883|SUPERIORITY_OR_OTHER|||||||0.164||||||The a prior threshold for statistical significance was p\<0.05.|RM-ANOVA|||||||0.164
70864655|NCT01686828|141214884|SUPERIORITY_OR_OTHER|||||||0.003|||||||RM-ANOVA|||Time-by-group interaction for fat mass||||0.003
70864656|NCT01686828|141214884|SUPERIORITY_OR_OTHER|||||||0.03||||||Time-by-group interaction for lean mass|RM-ANOVA|||||||0.03
70864657|NCT01686828|141214885|OTHER||||||>|0.1|||||||ANOVA|||The null hypothesis was that short-term testosterone deprivation would not affect lipoprotein lipase expression in adipose tissue. Repeated measures ANOVA was used to determine if a time-by-group effect was apparent for lipoprotein lipase expression.||||>0.1
70948091|NCT00267098|141397007|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.189|TWO_SIDED|95.0|0.78|2.01||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, were calculated. A probability ≥ 0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.|The hazard ratio corresponds to the time from randomization to first ventricular arrhythmia occurring post-randomization for each subject. Ventricular arrhythmias occurring prior to randomization were excluded. A 95% credible interval was used.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, NYHA classifications of I-III, and indicated for defibrillation therapy who receive biventricular (BiV) pacing have the same rate of experiencing their first ventricular arrhythmia as corresponding patients who receive right ventricular pacing. This was tested against the one-side hypothesis that patients with BiV pacing have a lower risk of ventricular arrhythmias than subjects with right ventricular pacing.||2.01|0.78|0.189
71139253|NCT03084796|141778119|SUPERIORITY||Mean Difference (Final Values)|0.069||||0.021|TWO_SIDED|95.0|0.011|0.128|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.128|0.011|0.021
71139254|NCT03084796|141778119|SUPERIORITY||Mean Difference (Final Values)|0.112|||<|0.001|TWO_SIDED|95.0|0.053|0.17|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.170|0.053|<0.001
71139255|NCT03084796|141778119|SUPERIORITY||Mean Difference (Final Values)|0.162|||<|0.001|TWO_SIDED|95.0|0.103|0.22|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.220|0.103|<0.001
71139256|NCT03084796|141778119|SUPERIORITY||Mean Difference (Final Values)|0.157|||<|0.001|TWO_SIDED|95.0|0.099|0.215|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.215|0.099|<0.001
71139257|NCT03084796|141778119|SUPERIORITY||Mean Difference (Final Values)|0.213|||<|0.001|TWO_SIDED|95.0|0.154|0.271|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.271|0.154|<0.001
71139258|NCT03084796|141778119|SUPERIORITY||Mean Difference (Final Values)|0.043||||0.149|TWO_SIDED|95.0|-0.015|0.101|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.101|-0.015|0.149
71139259|NCT03084796|141778119|SUPERIORITY||Mean Difference (Final Values)|0.092||||0.002|TWO_SIDED|95.0|0.034|0.151|||Mixed Models Analysis|||"week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.151|0.034|0.002
71139260|NCT03084796|141778119|SUPERIORITY||Mean Difference (Final Values)|0.088||||0.003|TWO_SIDED|95.0|0.031|0.146|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.146|0.031|0.003
70872191|NCT00489541|141229616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||<|0.0001|TWO_SIDED|95.0|-0.54|-0.3|||t-test, 2 sided|||A superiority test of TAXUX Element vs bare metal (BMS) Express historical control. The null hypothesis that the true difference in means (TAXUS Element - BMS Express) is equal to zero was tested against the two-sided alternative that the true difference in means is different from zero. A sample size of 224 patients in the TAXUS Element group (190 after 15% attrition due to angiographic follow-up) provided 85% power.||-0.30|-0.54|<0.0001
71139261|NCT03084796|141778119|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.096|TWO_SIDED|95.0|-0.009|0.108|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.108|-0.009|0.096
71139262|NCT03084796|141778119|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.122|TWO_SIDED|95.0|-0.012|0.103|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.103|-0.012|0.122
71139263|NCT03084796|141778119|SUPERIORITY||Mean Difference (Final Values)|-0.004||||0.886|TWO_SIDED|95.0|-0.062|0.054|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.054|-0.062|0.886
71139264|NCT03084796|141778120|SUPERIORITY||Mean Difference (Final Values)|0.074||||0.029|TWO_SIDED|95.0|0.008|0.141|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.141|0.008|0.029
70948092|NCT02353871|141397029|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 29||||<0.0001
70948093|NCT02353871|141397030|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 8 - BTX-A-HAC NG solution (50 U) versus placebo||||<0.0001
71139265|NCT03084796|141778120|SUPERIORITY||Mean Difference (Final Values)|0.121|||<|0.001|TWO_SIDED|95.0|0.055|0.188|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.188|0.055|<0.001
71139266|NCT03084796|141778120|SUPERIORITY||Mean Difference (Final Values)|0.184|||<|0.001|TWO_SIDED|95.0|0.117|0.25|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.250|0.117|<0.001
71139267|NCT03084796|141778120|SUPERIORITY||Mean Difference (Final Values)|0.208|||<|0.001|TWO_SIDED|95.0|0.142|0.275|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.275|0.142|<0.001
71139268|NCT03084796|141778120|SUPERIORITY||Mean Difference (Final Values)|0.293|||<|0.001|TWO_SIDED|95.0|0.227|0.36|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.360|0.227|<0.001
71139269|NCT03084796|141778120|SUPERIORITY||Mean Difference (Final Values)|0.047||||0.161|TWO_SIDED|95.0|-0.019|0.113|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.113|-0.019|0.161
71139270|NCT03084796|141778120|SUPERIORITY||Mean Difference (Final Values)|0.109||||0.001|TWO_SIDED|95.0|0.043|0.176|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.176|0.043|0.001
71139271|NCT03084796|141778120|SUPERIORITY||Mean Difference (Final Values)|0.134|||<|0.001|TWO_SIDED|95.0|0.068|0.201|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.201|0.068|<0.001
71139272|NCT03084796|141778120|SUPERIORITY||Mean Difference (Final Values)|0.062||||0.066|TWO_SIDED|95.0|-0.004|0.128|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.128|-0.004|0.066
71139273|NCT03084796|141778120|SUPERIORITY||Mean Difference (Final Values)|0.087||||0.01|TWO_SIDED|95.0|0.021|0.153|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.153|0.021|0.010
71139274|NCT03084796|141778120|SUPERIORITY||Mean Difference (Final Values)|0.025||||0.465|TWO_SIDED|95.0|-0.042|0.091|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.091|-0.042|0.465
71139275|NCT03084796|141778120|SUPERIORITY||Mean Difference (Final Values)|0.112||||0.008|TWO_SIDED|95.0|0.03|0.195|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.195|0.030|0.008
71139276|NCT03084796|141778120|SUPERIORITY||Mean Difference (Final Values)|0.173|||<|0.001|TWO_SIDED|95.0|0.091|0.256|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.256|0.091|<0.001
71139277|NCT03084796|141778120|SUPERIORITY||Mean Difference (Final Values)|0.219|||<|0.001|TWO_SIDED|95.0|0.136|0.302|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.302|0.136|<0.001
71139278|NCT03084796|141778120|SUPERIORITY||Mean Difference (Final Values)|0.213|||<|0.001|TWO_SIDED|95.0|0.131|0.295|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.295|0.131|<0.001
70948094|NCT02353871|141397030|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 15 - BTX-A-HAC NG solution (50 U) versus placebo||||<0.0001
71139279|NCT03084796|141778120|SUPERIORITY||Mean Difference (Final Values)|0.326|||<|0.001|TWO_SIDED|95.0|0.244|0.409|||McNemar|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.409|0.244|<0.001
70864658|NCT02484690|141214924|SUPERIORITY||Difference in Least Squares Means|1.57||||0.5244|TWO_SIDED|80.0|-1.6|4.74||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: BCVA at BL; Unstructured cov|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||4.74|-1.60|0.5244
71139280|NCT03084796|141778120|SUPERIORITY||Mean Difference (Final Values)|0.061||||0.144|TWO_SIDED|95.0|-0.021|0.143|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.143|-0.021|0.144
71139281|NCT03084796|141778120|SUPERIORITY||Mean Difference (Final Values)|0.107||||0.011|TWO_SIDED|95.0|0.024|0.189|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.189|0.024|0.011
71139282|NCT03084796|141778120|SUPERIORITY||Mean Difference (Final Values)|0.101||||0.016|TWO_SIDED|95.0|0.019|0.182|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.182|0.019|0.016
71139283|NCT03084796|141778120|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.28|TWO_SIDED|95.0|-0.037|0.128|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.128|-0.037|0.280
71139284|NCT03084796|141778120|SUPERIORITY||Mean Difference (Final Values)|0.039||||0.342|TWO_SIDED|95.0|-0.042|0.121|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.121|-0.042|0.342
71139285|NCT03084796|141778120|SUPERIORITY||Mean Difference (Final Values)|-0.006||||0.886|TWO_SIDED|95.0|-0.088|0.076|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.076|-0.088|0.886
71139286|NCT03084796|141778121|SUPERIORITY||Mean Difference (Final Values)|0.097||||0.003|TWO_SIDED|95.0|0.032|0.163|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.163|0.032|0.003
71139287|NCT03084796|141778121|SUPERIORITY||Mean Difference (Final Values)|0.156|||<|0.001|TWO_SIDED|95.0|0.091|0.221|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.221|0.091|<0.001
70948095|NCT02353871|141397030|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 57 - BTX-A-HAC NG solution (50 U) versus placebo||||<0.0001
71139288|NCT03084796|141778121|SUPERIORITY||Mean Difference (Final Values)|0.208|||<|0.001|TWO_SIDED|95.0|0.143|0.273|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.273|0.143|<0.001
71139289|NCT03084796|141778121|SUPERIORITY||Mean Difference (Final Values)|0.237|||<|0.001|TWO_SIDED|95.0|0.172|0.302|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.302|0.172|<0.001
71139290|NCT03084796|141778121|SUPERIORITY||Mean Difference (Final Values)|0.276|||<|0.001|TWO_SIDED|95.0|0.211|0.341|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.341|0.211|<0.001
71139291|NCT03084796|141778121|SUPERIORITY||Mean Difference (Final Values)|0.059||||0.076|TWO_SIDED|95.0|-0.006|0.124|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.124|-0.006|0.076
71139292|NCT03084796|141778121|SUPERIORITY||Mean Difference (Final Values)|0.111|||<|0.001|TWO_SIDED|95.0|0.046|0.176|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.176|0.046|<0.001
71139293|NCT03084796|141778121|SUPERIORITY||Mean Difference (Final Values)|0.14|||<|0.001|TWO_SIDED|95.0|0.075|0.205|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.205|0.075|<0.001
71139294|NCT03084796|141778121|SUPERIORITY||Mean Difference (Final Values)|0.052||||0.116|TWO_SIDED|95.0|-0.013|0.117|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.117|-0.013|0.116
71139295|NCT03084796|141778121|SUPERIORITY||Mean Difference (Final Values)|0.081||||0.014|TWO_SIDED|95.0|0.016|0.146|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.146|0.016|0.014
71139296|NCT03084796|141778121|SUPERIORITY||Mean Difference (Final Values)|0.029||||0.384|TWO_SIDED|95.0|-0.036|0.094|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.094|-0.036|0.384
71139297|NCT03084796|141778121|SUPERIORITY||Mean Difference (Final Values)|0.15|||<|0.001|TWO_SIDED|95.0|0.064|0.236|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.236|0.064|<0.001
71139298|NCT03084796|141778121|SUPERIORITY||Mean Difference (Final Values)|0.204|||<|0.001|TWO_SIDED|95.0|0.118|0.29|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.290|0.118|<0.001
71139299|NCT03084796|141778121|SUPERIORITY||Mean Difference (Final Values)|0.248|||<|0.001|TWO_SIDED|95.0|0.162|0.335|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.335|0.162|<0.001
71139300|NCT03084796|141778121|SUPERIORITY||Mean Difference (Final Values)|0.254|||<|0.001|TWO_SIDED|95.0|0.168|0.339|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.339|0.168|<0.001
71139301|NCT03084796|141778121|SUPERIORITY||Mean Difference (Final Values)|0.354|||<|0.001|TWO_SIDED|95.0|0.268|0.439|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.439|0.268|<0.001
71139302|NCT03084796|141778121|SUPERIORITY||Mean Difference (Final Values)|0.054||||0.214|TWO_SIDED|95.0|-0.031|0.14|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.140|-0.031|0.214
71139303|NCT03084796|141778121|SUPERIORITY||Mean Difference (Final Values)|0.098||||0.025|TWO_SIDED|95.0|0.012|0.184|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.184|0.012|0.025
71139304|NCT03084796|141778121|SUPERIORITY||Mean Difference (Final Values)|0.104||||0.016|TWO_SIDED|95.0|0.019|0.189|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.189|0.019|0.016
71139305|NCT03084796|141778121|SUPERIORITY||Mean Difference (Final Values)|0.044||||0.313|TWO_SIDED|95.0|-0.042|0.13|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.130|-0.042|0.313
71139306|NCT03084796|141778121|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.25|TWO_SIDED|95.0|-0.035|0.135|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure.~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.135|-0.035|0.250
71139307|NCT03084796|141778121|SUPERIORITY||Mean Difference (Final Values)|0.006||||0.898|TWO_SIDED|95.0|-0.08|0.091|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.091|-0.080|0.898
71139308|NCT03084796|141778122|SUPERIORITY||Mean Difference (Final Values)|0.079||||0.035|TWO_SIDED|95.0|0.006|0.153|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed, using linear mixed model for repeated measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.153|0.006|0.035
71139309|NCT03084796|141778122|SUPERIORITY||Mean Difference (Final Values)|0.158|||<|0.001|TWO_SIDED|95.0|0.085|0.232|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.232|0.085|<0.001
70948096|NCT02353871|141397030|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 85 - BTX-A-HAC NG solution (50 U) versus placebo||||<0.0001
70948097|NCT02353871|141397030|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 113 - BTX-A-HAC NG solution (50 U) versus placebo||||<0.0001
70948098|NCT02353871|141397030|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0035||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 148 - BTX-A-HAC NG solution (50 U) versus placebo||||0.0035
70948099|NCT02353871|141397030|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0441||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 183 (End of Study) - BTX-A-HAC NG solution (50 U) versus placebo||||0.0441
70948100|NCT02353871|141397031|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2422||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of the proportion of responders on Day 29 who remained responders at Day 57 - BTX-A-HAC NG solution (50 U) versus Placebo||||0.2422
70864659|NCT02484690|141214924|SUPERIORITY||Difference in Least Squares Means|-1.59||||0.5308|TWO_SIDED|80.0|-4.86|1.67||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: BCVA at BL; Unstructured cov|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||1.67|-4.86|0.5308
70948101|NCT02353871|141397031|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0917||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of the proportion of responders on Day 29 who remained responders at Day 85 - BTX-A-HAC NG solution (50 U) versus Placebo||||0.0917
70948102|NCT02353871|141397031|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7064||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of the proportion of responders on Day 29 who remained responders at Day 113 - BTX-A-HAC NG solution (50 U) versus Placebo||||0.7064
70948103|NCT02353871|141397031|SUPERIORITY_OR_OTHER_LEGACY|||||||0.701||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of the proportion of responders on Day 29 who remained responders at Day 148 - BTX-A-HAC NG solution (50 U) versus Placebo||||0.7010
71139310|NCT03084796|141778122|SUPERIORITY||Mean Difference (Final Values)|0.201|||<|0.001|TWO_SIDED|95.0|0.127|0.275|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.275|0.127|<0.001
71139311|NCT03084796|141778122|SUPERIORITY||Mean Difference (Final Values)|0.241|||<|0.001|TWO_SIDED|95.0|0.168|0.315|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.315|0.168|<0.001
70948104|NCT02353871|141397031|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7894||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of the proportion of responders on Day 29 who remained responders at Day 183 - BTX-A-HAC NG solution (50 U) versus Placebo||||0.7894
70948105|NCT02353871|141397032|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 8||||<0.0001
70948106|NCT02353871|141397032|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 15||||<0.0001
70948107|NCT02353871|141397032|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 29||||<0.0001
70948108|NCT02353871|141397032|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 57||||<0.0001
70948109|NCT02353871|141397032|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 85||||<0.0001
70948110|NCT02353871|141397032|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 113||||<0.0001
71139312|NCT03084796|141778122|SUPERIORITY||Mean Difference (Final Values)|0.277|||<|0.001|TWO_SIDED|95.0|0.204|0.351|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.351|0.204|<0.001
71139313|NCT03084796|141778122|SUPERIORITY||Mean Difference (Final Values)|0.079||||0.035|TWO_SIDED|95.0|0.005|0.152|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.152|0.005|0.035
71139314|NCT03084796|141778122|SUPERIORITY||Mean Difference (Final Values)|0.121||||0.001|TWO_SIDED|95.0|0.048|0.195|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.195|0.048|0.001
71139315|NCT03084796|141778122|SUPERIORITY||Mean Difference (Final Values)|0.162|||<|0.001|TWO_SIDED|95.0|0.088|0.235|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.235|0.088|<0.001
71139316|NCT03084796|141778122|SUPERIORITY||Mean Difference (Final Values)|0.043||||0.256|TWO_SIDED|95.0|-0.031|0.116|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.116|-0.031|0.256
71139317|NCT03084796|141778122|SUPERIORITY||Mean Difference (Final Values)|0.083||||0.027|TWO_SIDED|95.0|0.01|0.156|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.156|0.010|0.027
71139318|NCT03084796|141778122|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.281|TWO_SIDED|95.0|-0.033|0.114|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.114|-0.033|0.281
71139319|NCT03084796|141778122|SUPERIORITY||Mean Difference (Final Values)|0.141||||0.003|TWO_SIDED|95.0|0.05|0.232|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.232|0.050|0.003
71139320|NCT03084796|141778122|SUPERIORITY||Mean Difference (Final Values)|0.197|||<|0.001|TWO_SIDED|95.0|0.106|0.288|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.288|0.106|<0.001
71139321|NCT03084796|141778122|SUPERIORITY||Mean Difference (Final Values)|0.249|||<|0.001|TWO_SIDED|95.0|0.157|0.34|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.340|0.157|<0.001
71139322|NCT03084796|141778122|SUPERIORITY||Mean Difference (Final Values)|0.245|||<|0.001|TWO_SIDED|95.0|0.155|0.336|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.336|0.155|<0.001
71139323|NCT03084796|141778122|SUPERIORITY||Mean Difference (Final Values)|0.348|||<|0.001|TWO_SIDED|95.0|0.258|0.439|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.439|0.258|<0.001
71139324|NCT03084796|141778122|SUPERIORITY||Mean Difference (Final Values)|0.056||||0.222|TWO_SIDED|95.0|-0.034|0.147|||Mixed Models Analysis|||"week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.147|-0.034|0.222
71139325|NCT03084796|141778122|SUPERIORITY||Hazard Ratio, log|0.108||||0.02|TWO_SIDED|95.0|0.017|0.199|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.199|0.017|0.020
71139326|NCT03084796|141778122|SUPERIORITY||Mean Difference (Final Values)|0.105||||0.022|TWO_SIDED|95.0|0.015|0.195|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.195|0.015|0.022
71139327|NCT03084796|141778122|SUPERIORITY||Mean Difference (Final Values)|0.052||||0.262|TWO_SIDED|95.0|-0.039|0.143|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.143|-0.039|0.262
71139328|NCT03084796|141778122|SUPERIORITY||Mean Difference (Final Values)|0.048||||0.29|TWO_SIDED|95.0|-0.041|0.138|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.138|-0.041|0.290
70864660|NCT02484690|141214924|SUPERIORITY||Difference in Least Squares Means|-1.51||||0.5309|TWO_SIDED|80.0|-4.62|1.59||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: BCVA at BL; Unstructured cov|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||1.59|-4.62|0.5309
70864661|NCT02484690|141214925|SUPERIORITY||Difference in Least Squares Means|-1.68||||0.3034|TWO_SIDED|80.0|-3.77|0.42||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: BCVA at BL; Unstructured cov|The mean difference was calculated as Arm E minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that the Arm E mean was different from Arm A mean.||0.42|-3.77|0.3034
70864662|NCT02484690|141214926|SUPERIORITY||Difference in Least Squares Means|5.63||||0.5527|TWO_SIDED|80.0|-6.52|17.77||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||17.77|-6.52|0.5527
70864663|NCT02484690|141214926|SUPERIORITY||Difference in Least Squares Means|-3.09||||0.7382|TWO_SIDED|80.0|-14.95|8.76||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||8.76|-14.95|0.7382
70948111|NCT02353871|141397032|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0015||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 183||||0.0015
70948112|NCT02353871|141397033|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 8||||<0.0001
71139329|NCT03084796|141778122|SUPERIORITY||Mean Difference (Final Values)|-0.004||||0.938|TWO_SIDED|95.0|-0.094|0.087|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.087|-0.094|0.938
71139330|NCT03084796|141778123|SUPERIORITY||Hazard Ratio (HR)|1.64||||0.002|TWO_SIDED|95.0|1.21|2.24|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using Cox proportional hazards model, including treatment, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and baseline FEV1 value as covariate."||2.24|1.21|0.002
71139331|NCT03084796|141778123|SUPERIORITY||Hazard Ratio (HR)|2.18|||<|0.001|TWO_SIDED|95.0|1.61|2.94|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.94|1.61|<0.001
71139332|NCT03084796|141778123|SUPERIORITY||Hazard Ratio (HR)|2.79|||<|0.001|TWO_SIDED|95.0|2.07|3.78|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||3.78|2.07|<0.001
71139333|NCT03084796|141778123|SUPERIORITY||Hazard Ratio (HR)|3.07|||<|0.001|TWO_SIDED|95.0|2.27|4.15|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||4.15|2.27|<0.001
71139334|NCT03084796|141778123|SUPERIORITY||Hazard Ratio (HR)|3.1|||<|0.001|TWO_SIDED|95.0|2.3|4.17|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||4.17|2.30|<0.001
71139335|NCT03084796|141778123|SUPERIORITY||Hazard Ratio (HR)|1.32||||0.052|TWO_SIDED|95.0|1.0|1.76|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.76|1.00|0.052
71139336|NCT03084796|141778123|SUPERIORITY||Hazard Ratio (HR)|1.7|||<|0.001|TWO_SIDED|95.0|1.28|2.26|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.26|1.28|<0.001
71139337|NCT03084796|141778123|SUPERIORITY||Hazard Ratio (HR)|1.87|||<|0.001|TWO_SIDED|95.0|1.41|2.48|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.48|1.41|<0.001
71139338|NCT03084796|141778123|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.074|TWO_SIDED|95.0|0.98|1.69|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.69|0.98|0.074
71139339|NCT03084796|141778123|SUPERIORITY||Hazard Ratio (HR)|1.41||||0.013|TWO_SIDED|95.0|1.08|1.85|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.85|1.08|0.013
71139340|NCT03084796|141778123|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.494|TWO_SIDED|95.0|0.84|1.44|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.44|0.84|0.494
71139341|NCT03084796|141778125|SUPERIORITY||Mean Difference (Final Values)|0.059||||0.017|TWO_SIDED|95.0|0.011|0.107|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.107|0.011|0.017
71139342|NCT03084796|141778125|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.001|TWO_SIDED|95.0|0.032|0.128|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.128|0.032|0.001
70948113|NCT02353871|141397033|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 15||||<0.0001
70948114|NCT02353871|141397033|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 29||||<0.0001
71139343|NCT03084796|141778125|SUPERIORITY||Mean Difference (Final Values)|0.122|||<|0.001|TWO_SIDED|95.0|0.074|0.17|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.170|0.074|<0.001
71139344|NCT03084796|141778125|SUPERIORITY||Hazard Ratio, log|0.111|||<|0.001|TWO_SIDED|95.0|0.063|0.159|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.159|0.063|<0.001
71139345|NCT03084796|141778125|SUPERIORITY||Mean Difference (Final Values)|0.122|||<|0.001|TWO_SIDED|95.0|0.074|0.17|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.170|0.074|<0.001
71139346|NCT03084796|141778125|SUPERIORITY||Mean Difference (Final Values)|0.021||||0.377|TWO_SIDED|95.0|-0.026|0.069|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.069|-0.026|0.377
71139347|NCT03084796|141778125|SUPERIORITY||Mean Difference (Final Values)|0.063||||0.01|TWO_SIDED|95.0|0.015|0.111|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.111|0.015|0.010
71139348|NCT03084796|141778125|SUPERIORITY||Mean Difference (Final Values)|0.052||||0.031|TWO_SIDED|95.0|0.005|0.1|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.100|0.005|0.031
71139349|NCT03084796|141778125|SUPERIORITY||Mean Difference (Final Values)|0.042||||0.085|TWO_SIDED|95.0|-0.006|0.089|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.089|-0.006|0.085
71139350|NCT03084796|141778125|SUPERIORITY||Mean Difference (Final Values)|0.031||||0.199|TWO_SIDED|95.0|-0.016|0.079|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.079|-0.016|0.199
70864664|NCT02484690|141214926|SUPERIORITY||Difference in Least Squares Means|-7.32||||0.3932|TWO_SIDED|80.0|-18.32|3.67||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||3.67|-18.32|0.3932
70864665|NCT02484690|141214927|SUPERIORITY||Difference in Percentage of Participants|-5.71||||0.2328|TWO_SIDED|80.0|-10.74|-0.69||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Fisher Exact||The difference was calculated as Arm E minus Arm A.|The null hypothesis (Ho) was that there was no difference between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm E was different from Arm A.||-0.69|-10.74|0.2328
70864666|NCT02484690|141214928|SUPERIORITY||Difference in Least Squares Means|-0.52||||0.9581|TWO_SIDED|80.0|-13.26|12.22||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||12.22|-13.26|0.9581
70864667|NCT02484690|141214928|SUPERIORITY||Difference in Least Squares Means|-10.08||||0.3166|TWO_SIDED|80.0|-22.99|2.82||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||2.82|-22.99|0.3166
70864668|NCT02484690|141214928|SUPERIORITY||Difference in Least Squares Means|-7.68||||0.4244|TWO_SIDED|80.0|-20.01|4.64||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||4.64|-20.01|0.4244
70864669|NCT02484690|141214929|SUPERIORITY||Difference in Percentage of Participants|-6.64||||0.5586|TWO_SIDED|80.0|-18.6|5.32||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Fisher Exact||The difference was calculated as Arm E minus Arm A.|The null hypothesis (Ho) was that there was no difference between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm E was different from Arm A.||5.32|-18.60|0.5586
70864670|NCT02484690|141214930|SUPERIORITY||Difference in Least Squares Means|1.0||||0.8536|TWO_SIDED|80.0|-5.93|7.93||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||7.93|-5.93|0.8536
70864671|NCT02484690|141214930|SUPERIORITY||Difference in Least Squares Means|8.14||||0.2303|TWO_SIDED|80.0|-0.56|16.83||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||16.83|-0.56|0.2303
71139351|NCT03084796|141778125|SUPERIORITY||Mean Difference (Final Values)|-0.011||||0.657|TWO_SIDED|95.0|-0.058|0.037|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.037|-0.058|0.657
71139352|NCT03084796|141778125|SUPERIORITY||Mean Difference (Final Values)|0.032||||0.246|TWO_SIDED|95.0|-0.022|0.086|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.086|-0.022|0.246
71139353|NCT03084796|141778125|SUPERIORITY||Mean Difference (Final Values)|0.1|||<|0.001|TWO_SIDED|95.0|0.046|0.154|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.154|0.046|<0.001
71139354|NCT03084796|141778125|SUPERIORITY||Mean Difference (Final Values)|0.119|||<|0.001|TWO_SIDED|95.0|0.064|0.173|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.173|0.064|<0.001
71139355|NCT03084796|141778125|SUPERIORITY||Mean Difference (Final Values)|0.142|||<|0.001|TWO_SIDED|95.0|0.088|0.196|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.196|0.088|<0.001
71139356|NCT03084796|141778125|SUPERIORITY||Mean Difference (Final Values)|0.124|||<|0.001|TWO_SIDED|95.0|0.07|0.178|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.178|0.070|<0.001
70872192|NCT00489541|141229617|SUPERIORITY_OR_OTHER||12-month TLR rate|7.34|||<|0.0001|ONE_SIDED|95.0||10.8|||Chi-squared|||One-sided, single-sample binomial test to compare the observed TLF rate in PERSEUS SV to the pre-specified performance goal (19.5%). The normal approximation of the test statistic was used. The null hypothesis that the true TAXUS Element TLF rate is greater than or equal to the performance goal was tested against the one-sided alternative that the true rate is less than the performance goal. A sample size of 224 patients (accounting for 5% attrition to follow-up) provided 80% power.||10.8||<0.0001
71139357|NCT03084796|141778125|SUPERIORITY||Mean Difference (Final Values)|0.068||||0.014|TWO_SIDED|95.0|0.014|0.121|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.121|0.014|0.014
71139358|NCT03084796|141778125|SUPERIORITY||Mean Difference (Final Values)|0.087||||0.002|TWO_SIDED|95.0|0.032|0.141|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.141|0.032|0.002
71139359|NCT03084796|141778125|SUPERIORITY||Mean Difference (Final Values)|0.11|||<|0.001|TWO_SIDED|95.0|0.057|0.163|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.163|0.057|<0.001
71139360|NCT03084796|141778125|SUPERIORITY||Mean Difference (Final Values)|0.019||||0.493|TWO_SIDED|95.0|-0.035|0.073|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.073|-0.035|0.493
71139361|NCT03084796|141778125|SUPERIORITY||Mean Difference (Final Values)|0.042||||0.119|TWO_SIDED|95.0|-0.011|0.096|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.096|-0.011|0.119
71139362|NCT03084796|141778125|SUPERIORITY||Mean Difference (Final Values)|0.023||||0.392|TWO_SIDED|95.0|-0.03|0.077|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.077|-0.030|0.392
71139363|NCT03084796|141778126|SUPERIORITY||Mean Difference (Final Values)|0.109||||0.023|TWO_SIDED|95.0|0.015|0.203|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model for repeated measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.203|0.015|0.023
71139364|NCT03084796|141778126|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.058|TWO_SIDED|95.0|-0.003|0.184|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.184|-0.003|0.058
71139365|NCT03084796|141778126|SUPERIORITY||Mean Difference (Final Values)|0.059||||0.215|TWO_SIDED|95.0|-0.035|0.153|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.153|-0.035|0.215
71139366|NCT03084796|141778126|SUPERIORITY||Mean Difference (Final Values)|0.093||||0.051|TWO_SIDED|95.0|-0.001|0.187|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.187|-0.001|0.051
71139367|NCT03084796|141778126|SUPERIORITY||Mean Difference (Final Values)|0.044||||0.364|TWO_SIDED|95.0|-0.051|0.138|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.138|-0.051|0.364
71139368|NCT03084796|141778126|SUPERIORITY||Mean Difference (Final Values)|-0.019||||0.694|TWO_SIDED|95.0|-0.112|0.074|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.074|-0.112|0.694
71139369|NCT03084796|141778126|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.297|TWO_SIDED|95.0|-0.143|0.044|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.044|-0.143|0.297
71139370|NCT03084796|141778126|SUPERIORITY||Mean Difference (Final Values)|-0.016||||0.734|TWO_SIDED|95.0|-0.109|0.077|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.077|-0.109|0.734
71139371|NCT03084796|141778126|SUPERIORITY||Mean Difference (Final Values)|-0.031||||0.514|TWO_SIDED|95.0|-0.124|0.062|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.062|-0.124|0.514
70948115|NCT02353871|141397033|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 57||||<0.0001
70948116|NCT02353871|141397033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 85||||0.0008
70948117|NCT02353871|141397033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0065||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 113||||0.0065
70872193|NCT02221947|141229629|OTHER||mean Tmax(h)|0.92|||||TWO_SIDED||||||||SD=0.206|Bryostatin plasma concentration: mean Tmax (h)||||
70948118|NCT02353871|141397033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0643||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 148||||0.0643
70948119|NCT02353871|141397033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.367||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 183||||0.3670
70948120|NCT02353871|141397034|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 8||||<0.0001
70948121|NCT02353871|141397034|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 15||||<0.0001
71139372|NCT03084796|141778126|SUPERIORITY||Mean Difference (Final Values)|0.003||||0.957|TWO_SIDED|95.0|-0.09|0.095|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.095|-0.090|0.957
71139373|NCT03084796|141778126|SUPERIORITY||Mean Difference (Final Values)|0.034||||0.479|TWO_SIDED|95.0|-0.06|0.127|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.127|-0.060|0.479
71139374|NCT03084796|141778126|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.687|TWO_SIDED|95.0|-0.079|0.12|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.120|-0.079|0.687
70948122|NCT02353871|141397034|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 29||||<0.0001
71139375|NCT03084796|141778126|SUPERIORITY||Mean Difference (Final Values)|0.066||||0.195|TWO_SIDED|95.0|-0.034|0.165|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.165|-0.034|0.195
71139376|NCT03084796|141778126|SUPERIORITY||Mean Difference (Final Values)|0.111||||0.03|TWO_SIDED|95.0|0.011|0.212|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.212|0.011|0.030
71139377|NCT03084796|141778126|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.112|TWO_SIDED|95.0|-0.019|0.179|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.179|-0.019|0.112
71139378|NCT03084796|141778126|SUPERIORITY||Mean Difference (Final Values)|0.074||||0.147|TWO_SIDED|95.0|-0.026|0.174|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.174|-0.026|0.147
71139379|NCT03084796|141778126|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.37|TWO_SIDED|95.0|-0.054|0.144|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.144|-0.054|0.370
71139380|NCT03084796|141778126|SUPERIORITY||Mean Difference (Final Values)|0.091||||0.074|TWO_SIDED|95.0|-0.009|0.19|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.190|-0.009|0.074
70872194|NCT02221947|141229629|OTHER||mean (h*ng/mL)|1.05|||||TWO_SIDED||||||||SD=0.330|Bryostatin plasma concentration AUC0-last (h\*ng/mL)||||
70872195|NCT01774604|141229639|SUPERIORITY_OR_OTHER|||||||0.33|||||||Fisher Exact|||||||0.33
70872196|NCT01774604|141229640|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
70872197|NCT01774604|141229641|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
70864672|NCT02484690|141214930|SUPERIORITY||Difference in Least Squares Means|1.08||||0.8406|TWO_SIDED|80.0|-5.79|7.95||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||7.95|-5.79|0.8406
70864673|NCT02484690|141214931|SUPERIORITY||Difference in Percentage of Participants|-0.77||||1|TWO_SIDED|80.0|-11.23|9.68||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Fisher Exact||The difference was calculated as Arm E minus Arm A.|The null hypothesis (Ho) was that there was no difference between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm E was different from Arm A.||9.68|-11.23|1.0000
70864674|NCT02484690|141214932|SUPERIORITY||Difference in Least Squares Means|12.65||||0.3798|TWO_SIDED|80.0|-5.81|31.11||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: FCPT at BL; Unstructured cov|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||31.11|-5.81|0.3798
70864675|NCT02484690|141214932|SUPERIORITY||Difference in Least Squares Means|0.88||||0.9529|TWO_SIDED|80.0|-18.3|20.03||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: FCPT at BL; Unstructured cov|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||20.03|-18.3|0.9529
70864676|NCT02484690|141214932|SUPERIORITY||Difference in Least Squares Means|32.81||||0.0208|TWO_SIDED|80.0|14.65|50.96||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: FCPT at BL; Unstructured cov|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||50.96|14.65|0.0208
70864677|NCT02484690|141214933|SUPERIORITY||Difference in Least Squares Means|-6.35||||0.5185|TWO_SIDED|80.0|-19.0|6.27||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: FCPT at BL; Unstructured cov|The mean difference was calculated as Arm E minus Arm A.|The null hypothesis (Ho) was that there was no difference between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm E was different from Arm A.||6.27|-19.0|0.5185
70864678|NCT02484690|141214934|SUPERIORITY||Difference in Least Squares Means|19.45||||0.1624|TWO_SIDED|80.0|1.61|37.29||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CST at BL; Unstructured cov|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||37.29|1.61|0.1624
70864679|NCT02484690|141214934|SUPERIORITY||Difference in Least Squares Means|2.79||||0.8475|TWO_SIDED|80.0|-15.8|21.37||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CST at BL; Unstructured cov|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||21.37|-15.8|0.8475
70864680|NCT02484690|141214934|SUPERIORITY||Difference in Least Squares Means|28.52||||0.0381|TWO_SIDED|80.0|10.93|46.11||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CST at BL; Unstructured cov|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||46.11|10.93|0.0381
70864681|NCT02484690|141214935|SUPERIORITY||Difference in Least Squares Means|-14.4||||0.2089|TWO_SIDED|80.0|-29.1|0.29||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CST at BL; Unstructured cov|The mean difference was calculated as Arm E minus Arm A.|The null hypothesis (Ho) was that there was no difference between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm E was different from Arm A.||0.29|-29.1|0.2089
70872198|NCT01774604|141229642|SUPERIORITY_OR_OTHER|||||||0.15|||||||Fisher Exact|||||||0.15
70872199|NCT01774604|141229643|SUPERIORITY_OR_OTHER|||||||0.75|||||||Fisher Exact|||||||0.75
70872200|NCT01774604|141229644|SUPERIORITY_OR_OTHER|||||||0.25|||||||Fisher Exact|||||||0.25
70872201|NCT01774604|141229645|SUPERIORITY_OR_OTHER|||||||0.1|||||||Fisher Exact|||||||0.10
70948123|NCT02353871|141397034|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 57||||<0.0001
70948124|NCT02353871|141397034|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - Dysport 50 U versus Placebo at Day 85||||<0.0001
71139381|NCT03084796|141778126|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.233|TWO_SIDED|95.0|-0.039|0.158|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.158|-0.039|0.233
71139382|NCT03084796|141778126|SUPERIORITY||Mean Difference (Final Values)|0.046||||0.369|TWO_SIDED|95.0|-0.054|0.145|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.145|-0.054|0.369
70948125|NCT02353871|141397034|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 113||||<0.0001
71139383|NCT03084796|141778126|SUPERIORITY||Mean Difference (Final Values)|0.014||||0.773|TWO_SIDED|95.0|-0.084|0.112|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.112|-0.084|0.773
71139384|NCT03084796|141778126|SUPERIORITY||Mean Difference (Final Values)|-0.031||||0.536|TWO_SIDED|95.0|-0.13|0.068|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.068|-0.130|0.536
71139385|NCT03084796|141778127|SUPERIORITY||Odds Ratio (OR)|1.05||||0.848|TWO_SIDED|95.0|0.62|1.77|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analysis based on logistic regression model - multiple logistic regression model, with treatment, US regions, smoking status at screening, and BDI as covariates."||1.77|0.62|0.848
71139386|NCT03084796|141778127|SUPERIORITY||Odds Ratio (OR)|1.35||||0.264|TWO_SIDED|95.0|0.8|2.28|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.28|0.80|0.264
71139387|NCT03084796|141778127|SUPERIORITY||Odds Ratio (OR)|1.29||||0.343|TWO_SIDED|95.0|0.76|2.18|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.18|0.76|0.343
71139388|NCT03084796|141778127|SUPERIORITY||Odds Ratio (OR)|1.74||||0.042|TWO_SIDED|95.0|1.02|2.98|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.98|1.02|0.042
71139389|NCT03084796|141778127|SUPERIORITY||Odds Ratio (OR)|1.2||||0.503|TWO_SIDED|95.0|0.71|2.02|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.02|0.71|0.503
71139390|NCT03084796|141778127|SUPERIORITY||Odds Ratio (OR)|1.28||||0.354|TWO_SIDED|95.0|0.76|2.16|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.16|0.76|0.354
71139391|NCT03084796|141778127|SUPERIORITY||Odds Ratio (OR)|1.22||||0.447|TWO_SIDED|95.0|0.73|2.07|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.07|0.73|0.447
71139392|NCT03084796|141778127|SUPERIORITY||Odds Ratio (OR)|1.66||||0.064|TWO_SIDED|95.0|0.97|2.83|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.83|0.97|0.064
71139393|NCT03084796|141778127|SUPERIORITY||Odds Ratio (OR)|0.96||||0.867|TWO_SIDED|95.0|0.57|1.62|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.62|0.57|0.867
71139394|NCT03084796|141778127|SUPERIORITY||Odds Ratio (OR)|1.29||||0.347|TWO_SIDED|95.0|0.76|2.22|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.22|0.76|0.347
71139395|NCT03084796|141778127|SUPERIORITY||Odds Ratio (OR)|1.35||||0.269|TWO_SIDED|95.0|0.79|2.32|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.32|0.79|0.269
70948126|NCT02353871|141397034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 148||||0.0011
70948127|NCT02353871|141397034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0036||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 183||||0.0036
70948128|NCT02353871|141397035|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 8||||<0.0001
70864682|NCT02484690|141214938|SUPERIORITY||Difference in Least Squares Means|-0.4||||0.6717|TWO_SIDED|80.0|-1.61|0.81||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CNV at BL; Unstructured cov|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||0.81|-1.61|0.6717
70864683|NCT02484690|141214938|SUPERIORITY||Difference in Least Squares Means|0.23||||0.8131|TWO_SIDED|80.0|-1.01|1.47||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CNV at BL; Unstructured cov|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||1.47|-1.01|0.8131
70864684|NCT02484690|141214938|SUPERIORITY||Difference in Least Squares Means|0.11||||0.9069|TWO_SIDED|80.0|-1.07|1.29||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CNV at BL; Unstructured cov|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between each of the treatment groups (Arms B, C, or D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arms B, C, or D means were different from Arm A mean.||1.29|-1.07|0.9069
70864685|NCT02484690|141214940|SUPERIORITY||Difference in Least Squares Means|-0.96||||0.3189|TWO_SIDED|80.0|-2.2|0.28||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CNV at BL; Unstructured cov|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||0.28|-2.20|0.3189
70864686|NCT02484690|141214940|SUPERIORITY||Difference in Least Squares Means|1.22||||0.2256|TWO_SIDED|80.0|-0.07|2.52||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CNV at BL; Unstructured cov|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||2.52|-0.07|0.2256
70864687|NCT02484690|141214940|SUPERIORITY||Difference in Least Squares Means|0.35||||0.7086|TWO_SIDED|80.0|-0.86|1.57||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CNV at BL; Unstructured cov|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||1.57|-0.86|0.7086
71139396|NCT03084796|141778127|SUPERIORITY||Odds Ratio (OR)|1.92||||0.018|TWO_SIDED|95.0|1.12|3.3|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure.~Analysis based on logistic regression model - multiple logistic regression model, with treatment, US regions, smoking status at screening, and BDI as covariates."||3.30|1.12|0.018
70948129|NCT02353871|141397035|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 15||||<0.0001
70948130|NCT02353871|141397035|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 29||||<0.0001
70948131|NCT02353871|141397035|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 57||||<0.0001
70864688|NCT02484690|141214942|SUPERIORITY||Difference in Least Squares Means|-0.78||||0.4353|TWO_SIDED|80.0|-2.07|0.51||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: leak at BL; Unstructured cov|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||0.51|-2.07|0.4353
70864689|NCT02484690|141214942|SUPERIORITY||Difference in Least Squares Means|1.45||||0.1652|TWO_SIDED|80.0|0.11|2.78||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: leak at BL; Unstructured cov|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||2.78|0.11|0.1652
70864690|NCT02484690|141214942|SUPERIORITY||Difference in Least Squares Means|0.5||||0.61111|TWO_SIDED|80.0|-0.76|1.75||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: leak at BL; Unstructured cov|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||1.75|-0.76|0.61111
71139397|NCT03084796|141778127|SUPERIORITY||Odds Ratio (OR)|2.59|||<|0.001|TWO_SIDED|95.0|1.5|4.49|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||4.49|1.50|<0.001
70864691|NCT04916769|141214997|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of ajusted geometric means|106.27|||||TWO_SIDED|90.0|97.76|115.53||||||Natural logarithm-transformed bosutinib AUCinf was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Bosutinib 500 mg capsule contents + applesauce 45 mL \[Test\] - Bosutinib 500 mg intact capsule \[Reference\]) and corresponding 90% confidence intervals (CIs) were obtained from the model.||115.53|97.76|
70864692|NCT04916769|141214997|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|101.93|||||TWO_SIDED|90.0|93.97|110.56||||||Natural logarithm-transformed bosutinib AUCinf was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Bosutinib 500 mg capsule contents + yogurt 45 mL \[Test\] - Bosutinib 500 mg intact capsule \[Reference\]) and corresponding 90% CIs were obtained from the model.||110.56|93.97|
70864693|NCT04916769|141214998|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|96.82|||||TWO_SIDED|90.0|86.37|108.53||||||Natural logarithm-transformed bosutinib Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Bosutinib 500 mg capsule contents + applesauce 45 mL \[Test\] - Bosutinib 500 mg intact capsule \[Reference\]) and corresponding 90% CIs were obtained from the model.||108.53|86.37|
70864694|NCT04916769|141214998|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|95.39|||||TWO_SIDED|90.0|85.34|106.61||||||Natural logarithm-transformed bosutinib Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Bosutinib 500 mg capsule contents + yogurt 45 mL \[Test\] - Bosutinib 500 mg intact capsule \[Reference\]) and corresponding 90% CIs were obtained from the model.||106.61|85.34|
71139398|NCT03084796|141778127|SUPERIORITY||Odds Ratio (OR)|3.08|||<|0.001|TWO_SIDED|95.0|1.75|5.44|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||5.44|1.75|<0.001
71139399|NCT03084796|141778127|SUPERIORITY||Odds Ratio (OR)|3.42|||<|0.001|TWO_SIDED|95.0|1.94|6.02|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||6.02|1.94|<0.001
70948132|NCT02353871|141397035|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 85||||<0.0001
71139400|NCT03084796|141778127|SUPERIORITY||Odds Ratio (OR)|2.45||||0.001|TWO_SIDED|95.0|1.41|4.26|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||4.26|1.41|0.001
70864695|NCT04916769|141214999|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|106.23|||||TWO_SIDED|90.0|97.54|115.68||||||Natural logarithm-transformed bosutinib AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Bosutinib 500 mg capsule contents + applesauce 45 mL \[Test\] - Bosutinib 500 mg intact capsule \[Reference\]) and corresponding 90% CIs were obtained from the model.||115.68|97.54|
70864696|NCT04916769|141214999|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|102.08|||||TWO_SIDED|90.0|93.95|110.91||||||Natural logarithm-transformed bosutinib AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Bosutinib 500 mg capsule contents + yogurt 45 mL \[Test\] - Bosutinib 500 mg intact capsule \[Reference\]) and corresponding 90% CIs were obtained from the model.||110.91|93.95|
70864697|NCT05268055|141215057|SUPERIORITY|||||||0.525|||||||t-test, 2 sided|||Group comparison of all participants.||||0.525
70864698|NCT05268055|141215057|SUPERIORITY|||||||0.045|||||||t-test, 2 sided|||Group comparison of participants less than age 33.||||0.045
70864699|NCT05268055|141215057|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||Group comparison of participants age 33 and greater.||||0.046
70864700|NCT05268055|141215058|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||Group comparison of all participants.||||0.200
70864701|NCT05268055|141215058|SUPERIORITY|||||||0.075|||||||t-test, 2 sided|||Group comparison of participants less than age 33.||||0.075
70864702|NCT05268055|141215058|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|||Group comparison of participants age 33 and greater.||||0.015
70864703|NCT05268055|141215059|SUPERIORITY|||||||0.246|||||||t-test, 2 sided|||Group comparison of all participants.||||0.246
70864704|NCT05268055|141215059|SUPERIORITY|||||||0.151|||||||t-test, 2 sided|||Group comparison of participants less than age 33.||||0.151
70864705|NCT05268055|141215059|SUPERIORITY|||||||0.033|||||||t-test, 2 sided|||Group comparison of participants age 33 and greater.||||0.033
70864706|NCT05268055|141215060|SUPERIORITY|||||||0.212|||||||t-test, 2 sided|||Group comparison of all participants.||||0.212
70864707|NCT05268055|141215060|SUPERIORITY|||||||0.893|||||||t-test, 2 sided|||Group comparison of participants less than age 33.||||0.893
70864708|NCT05268055|141215060|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||Group comparison of participants age 33 and greater.||||0.160
70864709|NCT05268055|141215061|SUPERIORITY|||||||0.752|||||||t-test, 2 sided|||Group comparison of self-rating scores on the Healthcare Provider Cultural Competence measure.||||0.752
70864710|NCT05268055|141215061|SUPERIORITY|||||||0.493|||||||t-test, 2 sided|||Group comparison of self-rating scores on the Ask, Understand, Remember Assessment.||||0.493
70864711|NCT05268055|141215061|SUPERIORITY|||||||0.085|||||||t-test, 2 sided|||Group comparison of self-rating scores on the Wake Forest Physician Trust Scale.||||0.085
70864712|NCT03507400|141215062|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
70864713|NCT03507400|141215062|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|Wilcoxon paired test||pooled comparison of the participants of the non-waiting list and the waiting list before and after Introvision||||0.003
70864714|NCT03507400|141215064|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
70864715|NCT03507400|141215065|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|Wilcoxon paired test||||||0.003
70864716|NCT03507400|141215066|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon paired test||||||0.001
70864717|NCT03507400|141215067|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon paired test||||||0.001
70864718|NCT03507400|141215071|SUPERIORITY|Wilcoxon paired test||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
70864719|NCT03507400|141215071|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
70864720|NCT03507400|141215071|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
70864721|NCT01555983|141215072|SUPERIORITY_OR_OTHER||Cochran-Armitage trend tes|0.0001|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||The number needed to treat (NNT) to achieve 30% pain reduction during the 8-hour period was 4 (95% CI: 2.1-25.3) for the lower dose vs. placebo, and 3 (95% CI: 1.6-4.2) for the higher dose versus placebo.||||<.05
70864722|NCT04195906|141215115|SUPERIORITY||Least Squares Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|1.328||0.877|TWO_SIDED|96.0|-2.46|3.0||The MMRM model includes fixed effect terms for randomized treatment, visit, baseline sodium thiosulfate use, baseline BWAT-CUA score and visit by randomized treatment interaction.|MMRM|MMRM=Mixed model for repeated measures Participant is fitted as random effect and an unstructured variance-covariance matrix is used.||||3.00|-2.46|0.877
70864723|NCT04195906|141215116|SUPERIORITY||Least Squares Mean Difference|11.49|STANDARD_ERROR_OF_MEAN|7.93||0.146|TWO_SIDED|96.0|-4.8|27.78||The MMRM model includes fixed effect terms for randomized treatment, visit, baseline sodium thiosulfate use, baseline Pain VAS and visit by randomized treatment interaction.|MMRM|MMRM: mixed model repeated measures. Participant is fitted as random effect and an unstructured variance-covariance matrix is used.||||27.78|-4.80|0.146
70864724|NCT04195906|141215117|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.237||0.706|TWO_SIDED|96.0|-0.38|0.56||The MMRM model includes fixed effect terms for randomized treatment, visit, baseline sodium thiosulfate use, baseline Pain VAS and visit by randomized treatment interaction.|MMRM|MMRM: mixed model repeated measures. Participant is fitted as random effect and an unstructured variance-covariance matrix is used.||||0.56|-0.38|0.706
70864725|NCT04195906|141215118|SUPERIORITY||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|2.63||0.995|TWO_SIDED|96.0|-5.27|5.24||The MMRM model includes fixed effect terms for randomized treatment, visit, baseline sodium thiosulfate use, baseline Pain VAS and visit by randomized treatment interaction.|MMRM|MMRM: mixed model repeated measures. Participant is fitted as random effect and an unstructured variance-covariance matrix is used.||||5.24|-5.27|0.995
70864726|NCT04195906|141215119|SUPERIORITY||Odds Ratio, log|1.54|STANDARD_ERROR_OF_MEAN|0.498||0.384|TWO_SIDED|95.0|0.58|4.09||This model includes the stratification factor sodium thiosulfate use at baseline and the treatment as covariates|Regression, Logistic|As there is only a measure post-baseline, a logistic regression model was run instead of a generalized estimating equations model.|The odds ratio displayed is the odds ratio of having an improved result of SNF472 versus Placebo. The results 'Worsened', 'Equal', and 'Missing' are combined in one category and it is the reference for the odds ratio calculation.|||4.09|0.58|0.384
71139401|NCT03084796|141778127|SUPERIORITY||Odds Ratio (OR)|1.35||||0.284|TWO_SIDED|95.0|0.78|2.35|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.35|0.78|0.284
71139402|NCT03084796|141778127|SUPERIORITY||Odds Ratio (OR)|1.61||||0.103|TWO_SIDED|95.0|0.91|2.84|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.84|0.91|0.103
71139403|NCT03084796|141778127|SUPERIORITY||Odds Ratio (OR)|1.78||||0.045|TWO_SIDED|95.0|1.01|3.14|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||3.14|1.01|0.045
71139404|NCT03084796|141778127|SUPERIORITY||Odds Ratio (OR)|1.19||||0.557|TWO_SIDED|95.0|0.67|2.12|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.12|0.67|0.557
71139405|NCT03084796|141778127|SUPERIORITY||Odds Ratio (OR)|1.32||||0.345|TWO_SIDED|95.0|0.74|2.34|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.34|0.74|0.345
71139406|NCT03084796|141778127|SUPERIORITY||Odds Ratio (OR)|1.11||||0.732|TWO_SIDED|95.0|0.61|2.0|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.00|0.61|0.732
71139407|NCT03084796|141778128|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.666|TWO_SIDED|95.0|-0.52|0.81|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the BDI, BDI by visit interaction as covariates."||0.81|-0.52|0.666
71139408|NCT03084796|141778128|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.224|TWO_SIDED|95.0|-0.25|1.07|||Mixed Models Analysis|||"week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.07|-0.25|0.224
71139409|NCT03084796|141778128|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.239|TWO_SIDED|95.0|-0.27|1.06|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.06|-0.27|0.239
71139410|NCT03084796|141778128|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.019|TWO_SIDED|95.0|0.13|1.46|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.46|0.13|0.019
70948133|NCT02353871|141397035|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 113||||<0.0001
71139411|NCT03084796|141778128|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.124|TWO_SIDED|95.0|-0.14|1.19|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.19|-0.14|0.124
71139412|NCT03084796|141778128|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.432|TWO_SIDED|95.0|-0.39|0.92|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.92|-0.39|0.432
71139413|NCT03084796|141778128|SUPERIORITY||Mean Difference (Net)|0.25||||0.454|TWO_SIDED|95.0|-0.41|0.91|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.91|-0.41|0.454
71139414|NCT03084796|141778128|SUPERIORITY||Mean Difference (Final Values)|0.65||||0.053|TWO_SIDED|95.0|-0.01|1.31|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.31|-0.01|0.053
71139415|NCT03084796|141778128|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.973|TWO_SIDED|95.0|-0.67|0.65|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.65|-0.67|0.973
71139416|NCT03084796|141778128|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.247|TWO_SIDED|95.0|-0.27|1.04|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.04|-0.27|0.247
71139417|NCT03084796|141778128|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.235|TWO_SIDED|95.0|-0.26|1.06|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.06|-0.26|0.235
71139418|NCT03084796|141778128|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.071|TWO_SIDED|95.0|-0.05|1.28|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.28|-0.05|0.071
71139419|NCT03084796|141778128|SUPERIORITY||Mean Difference (Final Values)|0.98||||0.004|TWO_SIDED|95.0|0.32|1.64|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.64|0.32|0.004
71139420|NCT03084796|141778128|SUPERIORITY||Mean Difference (Final Values)|1.01||||0.003|TWO_SIDED|95.0|0.35|1.68|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.68|0.35|0.003
71139421|NCT03084796|141778128|SUPERIORITY||Mean Difference (Final Values)|1.52|||<|0.001|TWO_SIDED|95.0|0.86|2.18|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.18|0.86|<0.001
71139422|NCT03084796|141778128|SUPERIORITY||Mean Difference (Final Values)|1.08||||0.002|TWO_SIDED|95.0|0.41|1.75|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.75|0.41|0.002
71139423|NCT03084796|141778128|SUPERIORITY||Mean Difference (Final Values)|0.37||||0.271|TWO_SIDED|95.0|-0.29|1.03|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.03|-0.29|0.271
71139424|NCT03084796|141778128|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.235|TWO_SIDED|95.0|-0.26|1.06|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.06|-0.26|0.235
71139425|NCT03084796|141778128|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.007|TWO_SIDED|95.0|0.25|1.56|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.56|0.25|0.007
71139426|NCT03084796|141778128|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.923|TWO_SIDED|95.0|-0.63|0.69|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.69|-0.63|0.923
71139427|NCT03084796|141778128|SUPERIORITY||Mean Difference (Final Values)|0.53||||0.108|TWO_SIDED|95.0|-0.12|1.19|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.19|-0.12|0.108
71139428|NCT03084796|141778128|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.134|TWO_SIDED|95.0|-0.16|1.16|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.16|-0.16|0.134
70948134|NCT02353871|141397035|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 148||||<0.0001
71139429|NCT03084796|141778129|SUPERIORITY||Mean Difference (Final Values)|7.88||||0.022|TWO_SIDED|95.0|1.13|14.63|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including inter-visit period, treatment by inter-visit period interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by inter-visit period interaction as covariates."||14.63|1.13|0.022
71139430|NCT03084796|141778129|SUPERIORITY||Mean Difference (Final Values)|6.78||||0.048|TWO_SIDED|95.0|0.07|13.48|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||13.48|0.07|0.048
71139431|NCT03084796|141778129|SUPERIORITY||Mean Difference (Final Values)|6.65||||0.053|TWO_SIDED|95.0|-0.09|13.4|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||13.40|-0.09|0.053
71139432|NCT03084796|141778129|SUPERIORITY||Mean Difference (Final Values)|9.29||||0.007|TWO_SIDED|95.0|2.55|16.04|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||16.04|2.55|0.007
71139433|NCT03084796|141778129|SUPERIORITY||Mean Difference (Final Values)|4.61||||0.191|TWO_SIDED|95.0|-2.31|11.53|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||11.53|-2.31|0.191
71139434|NCT03084796|141778129|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.747|TWO_SIDED|95.0|-7.8|5.6|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||5.60|-7.80|0.747
70948135|NCT02353871|141397035|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 183||||<0.0001
71139435|NCT03084796|141778129|SUPERIORITY||Mean Difference (Final Values)|-1.23||||0.72|TWO_SIDED|95.0|-7.96|5.5|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||5.50|-7.96|0.720
71139436|NCT03084796|141778129|SUPERIORITY||Mean Difference (Final Values)|1.41||||0.68|TWO_SIDED|95.0|-5.31|8.14|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||8.14|-5.31|0.680
71139437|NCT03084796|141778129|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.971|TWO_SIDED|95.0|-6.82|6.57|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||6.57|-6.82|0.971
70948136|NCT02353871|141397036|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Log Rank|||Comparison of time to onset of treatment response - BTX-A-HAC NG solution (50 U) versus Placebo||||<0.0001
70948137|NCT02353871|141397036|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|6.561|||<|0.0001|TWO_SIDED||||||Cox proportional hazard model|Centre, gender and ILA baseline severity score used as covariates.||Comparison of time to onset of treatment response - BTX-A-HAC NG solution (50 U) versus placebo||||<0.0001
70948138|NCT01527162|141397048|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
70948139|NCT01527162|141397049|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.14|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||= 0.14
70948140|NCT01527162|141397050|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.54|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon Sign Rank TEst||||>.54
70948141|NCT01527162|141397050|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.2|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||= 0.20
70948142|NCT04599907|141397055|SUPERIORITY||||||<|0.05|||||||Cochran-Mantel-Haenszel|||||||<0.05
71139438|NCT03084796|141778129|SUPERIORITY||Mean Difference (Final Values)|2.52||||0.46|TWO_SIDED|95.0|-4.17|9.21|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||9.21|-4.17|0.460
71139439|NCT03084796|141778129|SUPERIORITY||Mean Difference (Final Values)|2.64||||0.441|TWO_SIDED|95.0|-4.09|9.37|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||9.37|-4.09|0.441
71139440|NCT03084796|141778129|SUPERIORITY||Mean Difference (Final Values)|6.76||||0.07|TWO_SIDED|95.0|-0.55|14.08|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||14.08|-0.55|0.070
71139441|NCT03084796|141778129|SUPERIORITY||Mean Difference (Final Values)|8.44||||0.023|TWO_SIDED|95.0|1.16|15.72|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||15.72|1.16|0.023
71139442|NCT03084796|141778129|SUPERIORITY||Mean Difference (Final Values)|6.96||||0.064|TWO_SIDED|95.0|-0.4|14.31|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||14.31|-0.40|0.064
71139443|NCT03084796|141778129|SUPERIORITY||Mean Difference (Final Values)|11.08||||0.003|TWO_SIDED|95.0|3.79|18.38|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||18.38|3.79|0.003
71139444|NCT03084796|141778129|SUPERIORITY||Mean Difference (Final Values)|4.2||||0.274|TWO_SIDED|95.0|-3.32|11.72|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||11.72|-3.32|0.274
71139445|NCT03084796|141778129|SUPERIORITY||Mean Difference (Final Values)|1.68||||0.649|TWO_SIDED|95.0|-5.57|8.93|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||8.93|-5.57|0.649
70864727|NCT04195906|141215120|SUPERIORITY||Difference in slopes between arms|0.57|STANDARD_ERROR_OF_MEAN|0.68||0.406|TWO_SIDED|95.0|-0.79|1.93||MMRM model includes fixed effect terms for randomized treatment, continuous variables maintenance opioid dose, Week (1 to 12) and Week by randomized treatment interaction. The random coefficients are the intercept and Week as a continuous variable.|MMRM|MMRM: mixed model repeated measures. An unstructured variance-covariance matrix is used||||1.93|-0.79|0.406
70948143|NCT04599907|141397056|SUPERIORITY||Mean Difference (Final Values)|-0.91|||<|0.05|TWO_SIDED|95.0|-1.42|-0.04|||Mixed Models Analysis|||"This is the data for the Level of Botherstatistical analysis"||-0.040|-1.42|<0.05
70948144|NCT04599907|141397056|SUPERIORITY||Mean Difference (Final Values)|-0.87|||<|0.05|TWO_SIDED|95.0|-1.35|-0.4|||Mixed Models Analysis|||"This is the data for the Level of Impact on Daily Activities Statistical Analysis"||-0.40|-1.35|<0.05
70948145|NCT02242643|141397077|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% CI for the difference in SCR (Fluzone® Quadrivalent Group minus FluLaval™ Quadrivalent Group) did not exceed 10% for each of the four strains.|Seroconversion rate (SCR) Difference (%)|-6.32|||||TWO_SIDED|95.0|-10.34|-2.27|||||For A/California/7/2009 (H1N1) vaccine strain.|||-2.27|-10.34|
70948146|NCT02242643|141397077|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% CI for the difference in SCR (Fluzone® Quadrivalent Group minus FluLaval™ Quadrivalent Group) did not exceed 10% for each of the four strains.|SCR Difference (%)|-6.74|||||TWO_SIDED|95.0|-10.68|-2.8|||||For A/Texas/50/2012 (H3N2) vaccine strain|||-2.80|-10.68|
71139446|NCT03084796|141778129|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.958|TWO_SIDED|95.0|-7.12|7.51|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||7.51|-7.12|0.958
71139447|NCT03084796|141778129|SUPERIORITY||Mean Difference (Final Values)|4.32||||0.242|TWO_SIDED|95.0|-2.93|11.58|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||11.58|-2.93|0.242
71139448|NCT03084796|141778129|SUPERIORITY||Mean Difference (Final Values)|-1.48||||0.69|TWO_SIDED|95.0|-8.77|5.81|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||5.81|-8.77|0.690
70864728|NCT00734474|141215171|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategies.|LS Mean Difference|-0.71|||<|0.001|TWO_SIDED|95.0|-0.87|-0.55||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||"Power was estimated at approximately 89% based on a simulation study using the most likely pharmacodynamic model, assuming a 20% drop out rate (missing completely at random) at 52 weeks and enrollment of 5 participants per week. A predictive power calculation was planned to select either 263 or 333 as the minimum total sample size needed (sum of Stage 1 and 2) per arm. If the predictive power of the higher LY2189265 dose based on 263 participants in total exceeded 85%, then 263 would be used."||-0.55|-0.87|<0.001
70948147|NCT02242643|141397077|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% CI for the difference in SCR (Fluzone® Quadrivalent Group minus FluLaval™ Quadrivalent Group) did not exceed 10% for each of the four strains.|SCR Difference (%)|-16.38|||||TWO_SIDED|95.0|-20.68|-12.02|||||For B/Massachusetts/2/2012 (Yamagata) vaccine strain|||-12.02|-20.68|
71139449|NCT03084796|141778129|SUPERIORITY||Mean Difference (Final Values)|2.64||||0.473|TWO_SIDED|95.0|-4.58|9.87|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||9.87|-4.58|0.473
71139450|NCT03084796|141778129|SUPERIORITY||Mean Difference (Final Values)|4.13||||0.267|TWO_SIDED|95.0|-3.17|11.43|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||11.43|-3.17|0.267
71139451|NCT03084796|141778129|SUPERIORITY||Mean Difference (Final Values)|7.32||||0.032|TWO_SIDED|95.0|0.65|13.99|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||13.99|0.65|0.032
71139452|NCT03084796|141778129|SUPERIORITY||Mean Difference (Final Values)|7.61||||0.025|TWO_SIDED|95.0|0.97|14.24|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||14.24|0.97|0.025
71139453|NCT03084796|141778129|SUPERIORITY||Mean Difference (Final Values)|6.8||||0.046|TWO_SIDED|95.0|0.12|13.49|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||13.49|0.12|0.046
71139454|NCT03084796|141778129|SUPERIORITY||Mean Difference (Final Values)|10.19||||0.003|TWO_SIDED|95.0|3.52|16.85|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||16.85|3.52|0.003
70864729|NCT00734474|141215171|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying a gatekeeping strategy.|LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.63|-0.31||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||"Power was estimated at approximately 89% based on a simulation study using the most likely pharmacodynamic model, assuming a 20% drop out rate (missing completely at random) at 52 weeks and enrollment of 5 participants per week. A predictive power calculation was planned to select either 263 or 333 as the minimum total sample size needed (sum of Stage 1 and 2) per arm. If the predictive power of the higher LY2189265 dose based on 263 participants in total exceeded 85%, then 263 would be used."||-0.31|-0.63|<0.001
70864730|NCT00734474|141215171|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.71|||<|0.001|TWO_SIDED|95.0|-0.87|-0.55||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis||-0.55|-0.87|<0.001
70948148|NCT02242643|141397077|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% CI for the difference in SCR (Fluzone® Quadrivalent Group minus FluLaval™ Quadrivalent Group) did not exceed 10% for each of the four strains.|SCR Difference (%)|-11.75|||||TWO_SIDED|95.0|-15.28|-8.21|||||For B/Brisbane/60/2008 (Victoria) vaccine strain.|||-8.21|-15.28|
70948149|NCT02242643|141397078|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio (Fluzone® Quadrivalent Group/FluLaval™ Quadrivalent Group) did not exceed 1.5 for each of the four strains.|Adjusted GMT ratio|0.85|||||TWO_SIDED|95.0|0.77|0.95|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|||0.95|0.77|
70948150|NCT02242643|141397078|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio (Fluzone® Quadrivalent Group/FluLaval™ Quadrivalent Group) did not exceed 1.5 for each of the four strains.|Adjusted GMT Ratio|0.85|||||TWO_SIDED|95.0|0.77|0.94|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|||0.94|0.77|
70948151|NCT02242643|141397078|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio (Fluzone® Quadrivalent Group/FluLaval™ Quadrivalent Group) did not exceed 1.5 for each of the four strains.|Adjusted GMT Ratio|0.65|||||TWO_SIDED|95.0|0.59|0.71|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|||0.71|0.59|
70948152|NCT02242643|141397078|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio (Fluzone® Quadrivalent Group/FluLaval™ Quadrivalent Group) did not exceed 1.5 for each of the four strains.|Adjusted GMT Ratio|0.62|||||TWO_SIDED|95.0|0.56|0.69|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|||0.69|0.56|
70948153|NCT02633397|141397107|SUPERIORITY|||||||0.19|||||||Regression, Logistic|||P- Value was the exact logistic regression adjusted for clinical site.||||0.19
70948154|NCT02633397|141397108|SUPERIORITY|||||||0.42|||||||Regression, Logistic|||P- Value was the exact logistic regression adjusted for clinical site.||||0.42
70948155|NCT02633397|141397109|SUPERIORITY|||||||0.52|||||||Regression, Logistic|||P- Value was the exact logistic regression adjusted for clinical site.||||0.52
70948156|NCT02633397|141397111|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.69|TWO_SIDED|90.0|-0.7|0.42|||ANCOVA|||ANCOVA model adjusted for clinic site||0.42|-0.70|0.69
71139455|NCT03084796|141778129|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.207|TWO_SIDED|95.0|-2.45|11.25|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||11.25|-2.45|0.207
71139456|NCT03084796|141778129|SUPERIORITY||Mean Difference (Final Values)|0.29||||0.932|TWO_SIDED|95.0|-6.33|6.91|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||6.91|-6.33|0.932
71139457|NCT03084796|141778129|SUPERIORITY||Mean Difference (Final Values)|-0.52||||0.879|TWO_SIDED|95.0|-7.17|6.14|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||6.14|-7.17|0.879
70948157|NCT02633397|141397112|SUPERIORITY||Mean Difference (Final Values)|-39.51||||0.4|TWO_SIDED|90.0|-117.05|38.02|||ANCOVA|||ANCOVA model adjusted for clinic site||38.02|-117.05|0.40
70948158|NCT02633397|141397113|SUPERIORITY||Mean Difference (Final Values)|0.31||||0.23|TWO_SIDED|90.0|-0.11|0.73|||Regression, Linear|||Linear regression model adjusted for clinic site||0.73|-0.11|0.23
70864731|NCT00734474|141215171|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.63|-0.31||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis||-0.31|-0.63|<0.001
70948159|NCT02633397|141397114|SUPERIORITY||Mean Difference (Final Values)|-0.08||||-0.8|TWO_SIDED|90.0|-0.62|0.46|||ANCOVA|||ANCOVA model adjusted for clinic site||0.46|-0.62|-0.80
70948160|NCT02633397|141397115|SUPERIORITY||Mean Difference (Final Values)|-6.96|||<|0.001|TWO_SIDED|90.0|-10.22|-3.69|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in MAP as a function of time, the interaction between time and study arm, and clinic site.||-3.69|-10.22|<0.001
70948161|NCT02633397|141397116|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.15|TWO_SIDED|90.0|-0.31|0.02|||ANCOVA|||ANCOVA model adjusted for clinic site||0.02|-0.31|0.15
70948162|NCT02633397|141397117|SUPERIORITY||Mean Difference (Final Values)|-6.7||||0.003|TWO_SIDED|90.0|-10.28|-3.12|||ANCOVA|||ANCOVA model adjusted for clinic site||-3.12|-10.28|0.003
70948163|NCT02633397|141397118|SUPERIORITY||Mean Difference (Final Values)|3.52|||<|0.001|TWO_SIDED|90.0|2.0|5.04|||ANCOVA|||ANCOVA model adjusted for clinic site||5.04|2.00|<0.001
71139458|NCT03084796|141778129|SUPERIORITY||Mean Difference (Final Values)|2.87||||0.396|TWO_SIDED|95.0|-3.77|9.5|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||9.50|-3.77|0.396
71139459|NCT03084796|141778129|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.812|TWO_SIDED|95.0|-7.44|5.83|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||5.83|-7.44|0.812
71139460|NCT03084796|141778129|SUPERIORITY||Mean Difference (Final Values)|2.58||||0.444|TWO_SIDED|95.0|-4.03|9.19|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||9.19|-4.03|0.444
71139461|NCT03084796|141778129|SUPERIORITY||Mean Difference (Final Values)|3.38||||0.319|TWO_SIDED|95.0|-3.27|10.04|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||10.04|-3.27|0.319
71139462|NCT03084796|141778130|SUPERIORITY||Mean Difference (Final Values)|-0.43|||<|0.001|TWO_SIDED|95.0|-0.67|-0.18|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed, using linear mixed model repeated for measurements (MMRM), including treatment, inter-visit period, treatment by inter-visit period interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by inter-visit period interaction as covariates."||-0.18|-0.67|<0.001
71139463|NCT03084796|141778130|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.023|TWO_SIDED|95.0|-0.53|-0.04|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.04|-0.53|0.023
71139464|NCT03084796|141778130|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.067|TWO_SIDED|95.0|-0.47|0.02|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.02|-0.47|0.067
71139465|NCT03084796|141778130|SUPERIORITY||Mean Difference (Final Values)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.66|-0.17|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.17|-0.66|<0.001
71139466|NCT03084796|141778130|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.084|TWO_SIDED|95.0|-0.47|0.03|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.03|-0.47|0.084
71139467|NCT03084796|141778130|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.243|TWO_SIDED|95.0|-0.1|0.39|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.39|-0.10|0.243
71139468|NCT03084796|141778130|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.112|TWO_SIDED|95.0|-0.05|0.44|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.44|-0.05|0.112
71139469|NCT03084796|141778130|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.929|TWO_SIDED|95.0|-0.23|0.26|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.26|-0.23|0.929
70948164|NCT02633397|141397119|SUPERIORITY||Mean Difference (Final Values)|286.56||||0.51|TWO_SIDED|90.0|-429.86|1002.99|||Regression, Linear|||Linear regression model adjusted for clinic site||1002.99|-429.86|0.51
71139470|NCT03084796|141778130|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.668|TWO_SIDED|95.0|-0.19|0.3|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.30|-0.19|0.668
71139471|NCT03084796|141778130|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.281|TWO_SIDED|95.0|-0.38|0.11|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.11|-0.38|0.281
70948165|NCT02633397|141397120|SUPERIORITY||Mean Difference (Final Values)|-82.18||||0.14|TWO_SIDED|90.0|-173.69|9.32|||Regression, Linear|||Linear regression model adjusted for clinic site||9.32|-173.69|0.14
70948166|NCT02633397|141397121|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept was used to compare microalbuminuria frequency as a function of time and the interaction between time and study arm.||||0.78
70948167|NCT02633397|141397122|SUPERIORITY|||||||0.3|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept was used to compare macroalbuminuria frequency as a function of time and the interaction between time and study arm.||||0.30
71139472|NCT03084796|141778130|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.134|TWO_SIDED|95.0|-0.43|0.06|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.06|-0.43|0.134
70948168|NCT02633397|141397123|SUPERIORITY||Mean Difference (Final Values)|-4.91||||0.06|TWO_SIDED|90.0|-9.21|-0.62|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in GFR as a function of time, the interaction between time and study arm, and clinic site.||-0.62|-9.21|0.06
70948169|NCT02633397|141397124|SUPERIORITY|||||||0.56|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept was used to compare CKD stage frequency as a function of time and the interaction between time and study arm.||||0.56
70948170|NCT02633397|141397125|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.15|TWO_SIDED|90.0|-0.52|0.03|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in hemoglobin as a function of time, the interaction between time and study arm, and clinic site.||0.03|-0.52|0.15
70948171|NCT02633397|141397126|SUPERIORITY||Mean Difference (Final Values)|1.47||||0.05|TWO_SIDED|90.0|0.22|2.72|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in reticulocyte count as a function of time, the interaction between time and study arm, and clinic site.||2.72|0.22|0.05
70948172|NCT02633397|141397127|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.75|TWO_SIDED|90.0|-0.93|0.63|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in WBC count as a function of time, the interaction between time and study arm, and clinic site.||0.63|-0.93|0.75
70948173|NCT02633397|141397128|SUPERIORITY||Mean Difference (Final Values)|-29.28||||0.17|TWO_SIDED|90.0|-64.63|6.08|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in WBC count as a function of time, the interaction between time and study arm, and clinic site.||6.08|-64.63|0.17
70948174|NCT02633397|141397129|SUPERIORITY||Mean Difference (Final Values)|-1.64||||0.07|TWO_SIDED|90.0|-3.13|-0.15|||Regression, Linear|||Linear regression model adjusted for clinic site||-0.15|-3.13|0.07
70948175|NCT03036124|141397138|SUPERIORITY||Hazard Ratio (HR)|0.74|||<|0.0001||95.0|0.65|0.85|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization and including the history of hospitalizations due to Heart failure as a factor.||||0.85|0.65|<0.0001
71139473|NCT03084796|141778130|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.003|TWO_SIDED|95.0|-0.7|-0.14|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.14|-0.70|0.003
71139474|NCT03084796|141778130|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.02|TWO_SIDED|95.0|-0.61|-0.05|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.05|-0.61|0.020
71139475|NCT03084796|141778130|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.017|TWO_SIDED|95.0|-0.62|-0.06|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.06|-0.62|0.017
71139476|NCT03084796|141778130|SUPERIORITY||Mean Difference (Final Values)|-0.52|||<|0.001|TWO_SIDED|95.0|-0.8|-0.24|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.24|-0.80|<0.001
71139477|NCT03084796|141778130|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.115|TWO_SIDED|95.0|-0.52|0.06|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.06|-0.52|0.115
71139478|NCT03084796|141778130|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.532|TWO_SIDED|95.0|-0.19|0.36|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.36|-0.19|0.532
71139479|NCT03084796|141778130|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.603|TWO_SIDED|95.0|-0.21|0.35|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.35|-0.21|0.603
71139480|NCT03084796|141778130|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.46|TWO_SIDED|95.0|-0.38|0.17|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.17|-0.38|0.460
71139481|NCT03084796|141778130|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.921|TWO_SIDED|95.0|-0.29|0.26|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD.~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.26|-0.29|0.921
71139482|NCT03084796|141778130|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.172|TWO_SIDED|95.0|-0.47|0.08|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.08|-0.47|0.172
71139483|NCT03084796|141778130|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.21|TWO_SIDED|95.0|-0.46|0.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.10|-0.46|0.210
70864732|NCT00734474|141215173|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.26|||<|0.001|TWO_SIDED|95.0|-1.42|-1.09||Comparison at 26 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis||-1.09|-1.42|<0.001
70864733|NCT00734474|141215173|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.05|||<|0.001|TWO_SIDED|95.0|-1.21|-0.88||Comparison at 26 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis||-0.88|-1.21|<0.001
70864734|NCT00734474|141215173|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.64|||<|0.001|TWO_SIDED|95.0|-0.81|-0.48||Comparison at 26 weeks. One-sided raw p-value with no adjustment for multiplicity.|ANCOVA|||||-0.48|-0.81|<0.001
70864735|NCT00734474|141215173|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying a gatekeeping strategy.|LS Mean Difference|-0.67|||<|0.001|TWO_SIDED|95.0|-0.84|-0.5||Comparison at 104 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||||-0.50|-0.84|<0.001
70864736|NCT00734474|141215173|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate controlled by applying gatekeeping strategy.|LS Mean Difference|-0.39|||<|0.001|TWO_SIDED|95.0|-0.56|-0.22||Comparison at 104 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||||-0.22|-0.56|<0.001
70864737|NCT00734474|141215173|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.67|||<|0.001|TWO_SIDED|95.0|-0.84|-0.5||Comparison at 104 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis||-0.50|-0.84|<0.001
70864738|NCT00734474|141215173|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.39|||<|0.001|TWO_SIDED|95.0|-0.56|-0.22||Comparison at 104 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis||-0.22|-0.56|<0.001
70864739|NCT00734474|141215175|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.89|||<|0.001|TWO_SIDED|95.0|-2.27|-1.51|||Mixed Models Analysis|Comparison at 26 weeks.||||-1.51|-2.27|<0.001
70864740|NCT00734474|141215175|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.48|||<|0.001|TWO_SIDED|95.0|-1.85|-1.1||Comparison at 26 weeks.|Mixed Models Analysis|||||-1.10|-1.85|<0.001
70864741|NCT00734474|141215175|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48||||0.012|TWO_SIDED|95.0|-0.86|-0.11||Comparison at 26 weeks.|Mixed Models Analysis|||||-0.11|-0.86|0.012
70864742|NCT00734474|141215175|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.47|||<|0.001|TWO_SIDED|95.0|-1.82|-1.13||Comparison at 52 weeks.|Mixed Models Analysis|||||-1.13|-1.82|<0.001
70864743|NCT00734474|141215175|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.73|||<|0.001|TWO_SIDED|95.0|-1.07|-0.39||Comparison at 52 weeks.|Mixed Models Analysis|||||-0.39|-1.07|<0.001
70864744|NCT00734474|141215175|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.51|||<|0.001|TWO_SIDED|95.0|-1.93|-1.1||Comparison at 104 weeks.|Mixed Models Analysis|||||-1.10|-1.93|<0.001
70864745|NCT00734474|141215175|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.92|||<|0.001|TWO_SIDED|95.0|-1.33|-0.51||Comparison at 104 weeks.|Mixed Models Analysis|||||-0.51|-1.33|<0.001
70864746|NCT00734474|141215176|SUPERIORITY_OR_OTHER||LS Mean Difference|18.51||||0.095|TWO_SIDED|95.0|-3.25|40.28||Comparison at 26 weeks.|Mixed Models Analysis|||||40.28|-3.25|0.095
70864747|NCT00734474|141215176|SUPERIORITY_OR_OTHER||LS Mean Difference|17.08||||0.121|TWO_SIDED|95.0|-4.54|38.69||Comparison at 26 weeks.|Mixed Models Analysis|||||38.69|-4.54|0.121
70864748|NCT00734474|141215176|SUPERIORITY_OR_OTHER||LS Mean Difference|15.41||||0.167|TWO_SIDED|95.0|-6.47|37.29||Comparison at 26 weeks.|Mixed Models Analysis|||||37.29|-6.47|0.167
70864749|NCT00734474|141215176|SUPERIORITY_OR_OTHER||LS Mean Difference|6.38||||0.43|TWO_SIDED|95.0|-9.49|22.26||Comparison at 52 weeks.|Mixed Models Analysis|||||22.26|-9.49|0.430
70864750|NCT00734474|141215176|SUPERIORITY_OR_OTHER||LS Mean Difference|8.77||||0.273|TWO_SIDED|95.0|-6.94|24.47||Comparison at 52 weeks.|Mixed Models Analysis|||||24.47|-6.94|0.273
70864751|NCT00734474|141215176|SUPERIORITY_OR_OTHER||LS Mean Difference|11.07||||0.291|TWO_SIDED|95.0|-9.49|31.64||Comparison at 104 weeks.|Mixed Models Analysis|||||31.64|-9.49|0.291
70864752|NCT00734474|141215176|SUPERIORITY_OR_OTHER||LS Mean Difference|21.28||||0.039|TWO_SIDED|95.0|1.03|41.53||Comparison at 104 weeks.|Mixed Models Analysis|||||41.53|1.03|0.039
70864753|NCT00734474|141215178|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|||<|0.001|TWO_SIDED|95.0|-2.27|-1.14||Comparison at 26 weeks.|ANCOVA|||||-1.14|-2.27|<0.001
70864754|NCT00734474|141215178|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.16|||<|0.001|TWO_SIDED|95.0|-1.73|-0.6||Comparison at 26 weeks.|ANCOVA|||||-0.60|-1.73|<0.001
70864755|NCT00734474|141215178|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.953|TWO_SIDED|95.0|-0.54|0.58||Comparison at 26 weeks.|ANCOVA|||||0.58|-0.54|0.953
70864756|NCT00734474|141215178|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|||<|0.001|TWO_SIDED|95.0|-2.08|-0.92||Comparison at 52 weeks.|ANCOVA|||||-0.92|-2.08|<0.001
70864757|NCT00734474|141215178|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.07|||<|0.001|TWO_SIDED|95.0|-1.65|-0.48||Comparison at 52 weeks.|ANCOVA|||||-0.48|-1.65|<0.001
70864758|NCT00734474|141215178|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.14|||<|0.001|TWO_SIDED|95.0|-1.78|-0.49||Comparison at 104 weeks.|ANCOVA|||||-0.49|-1.78|<0.001
70864759|NCT00734474|141215178|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.64||||0.054|TWO_SIDED|95.0|-1.29|0.01||Comparison at 104 weeks.|ANCOVA|||||0.01|-1.29|0.054
70864760|NCT00734474|141215180|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.69|||<|0.001|TWO_SIDED|95.0|-2.45|-0.93||Comparison at 26 weeks.|Mixed Models Analysis|||||-0.93|-2.45|<0.001
70864761|NCT00734474|141215180|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58||||0.133|TWO_SIDED|95.0|-1.34|0.18||Comparison at 26 weeks.|Mixed Models Analysis|||||0.18|-1.34|0.133
70864762|NCT00734474|141215180|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25||||0.512|TWO_SIDED|95.0|-1.01|0.5||Comparison at 26 weeks.|Mixed Models Analysis|||||0.50|-1.01|0.512
70864763|NCT00734474|141215180|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.46|||<|0.001|TWO_SIDED|95.0|-2.23|-0.69||Comparison at 52 weeks.|Mixed Models Analysis|||||-0.69|-2.23|<0.001
70864764|NCT00734474|141215180|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.59||||0.128|TWO_SIDED|95.0|-1.36|0.17||Comparison at 52 weeks.|Mixed Models Analysis|||||0.17|-1.36|0.128
70864765|NCT00734474|141215180|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.36||||0.005|TWO_SIDED|95.0|-2.3|-0.42||Comparison at 104 weeks.|Mixed Models Analysis|||||-0.42|-2.30|0.005
70864766|NCT00734474|141215180|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54||||0.256|TWO_SIDED|95.0|-1.48|0.4||Comparison at 104 weeks.|Mixed Models Analysis|||||0.40|-1.48|0.256
70864767|NCT00734474|141215181|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.3|||<|0.001|TWO_SIDED|95.0|6.8|18.8||Comparison of HbA1c \<7.0% at 26 weeks.|Regression, Logistic|||||18.8|6.8|<0.001
70864768|NCT00734474|141215181|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.6|||<|0.001|TWO_SIDED|95.0|5.2|14.3||Comparison of HbA1c \<7.0% at 26 weeks.|Regression, Logistic|||||14.3|5.2|<0.001
70948176|NCT03036124|141397139|SUPERIORITY||Hazard Ratio (HR)|0.75|||<|0.0001||95.0|0.65|0.85|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization and including the history of hospitalizations due to Heart failure as a factor.||||0.85|0.65|<0.0001
70948177|NCT03036124|141397140|SUPERIORITY||Rate Ratio (RR)|0.75||||0.0002||95.0|0.65|0.88|||LWYY proportional rates model|Stratified by Type 2 Diabetes status at randomization and including the history of hospitalizations due to Heart failure as a factor.||||0.88|0.65|0.0002
70864769|NCT00734474|141215181|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.0|||<|0.001|TWO_SIDED|95.0|1.8|4.8||Comparison of HbA1c \<7.0% at 26 weeks.|Regression, Logistic|||||4.8|1.8|<0.001
70864770|NCT00734474|141215181|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0|||<|0.001|TWO_SIDED|95.0|2.7|5.9||Comparison of HbA1c \<7.0% at 52 weeks.|Regression, Logistic|||||5.9|2.7|<0.001
70864771|NCT00734474|141215181|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.7|||<|0.001|TWO_SIDED|95.0|1.8|3.9||Comparison of HbA1c \<7.0% at 52 weeks.|Regression, Logistic|||||3.9|1.8|<0.001
70864772|NCT00734474|141215181|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.4|||<|0.001|TWO_SIDED|95.0|2.4|5.0||Comparison of HbA1c \<7.0% at 104 weeks.|Regression, Logistic|||||5.0|2.4|<0.001
70948178|NCT03036124|141397141|SUPERIORITY||Win Ratio (WR)|1.18|||<|0.0001||95.0|1.11|1.26||The p-value is obtained from a rank ANCOVA adjusted for baseline KCCQ score and stratified by T2DM status at randomization.|Win Ratio|Stratified by Type 2 Diabetes status at randomization and including baseline score as a covariate.|The composite of change from baseline in total symptom score at 8 months, or death before 8 months.|||1.26|1.11|<0.0001
70948179|NCT03036124|141397142|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.1681||95.0|0.44|1.16|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization and including baseline eGFR as a covariate.||||1.16|0.44|0.1681
70948180|NCT03036124|141397143|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0217||95.0|0.71|0.97|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization.||||0.97|0.71|0.0217
70864773|NCT00734474|141215181|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.6|3.3||Comparison of HbA1c \<7.0% at 104 weeks.|Regression, Logistic|||||3.3|1.6|<0.001
70864774|NCT00734474|141215181|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.5|||<|0.001|TWO_SIDED|95.0|6.5|20.4||Comparison of HbA1c ≤6.5% at 26 weeks.|Regression, Logistic|||||20.4|6.5|<0.001
70864775|NCT00734474|141215181|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0|||<|0.001|TWO_SIDED|95.0|2.8|8.8||Comparison of HbA1c ≤6.5% at 26 weeks.|Regression, Logistic|||||8.8|2.8|<0.001
70864776|NCT00734474|141215181|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3||||0.005|TWO_SIDED|95.0|1.3|4.1||Comparison of HbA1c ≤6.5 at 26 weeks.|Regression, Logistic|||||4.1|1.3|0.005
70864777|NCT00734474|141215181|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.001|TWO_SIDED|95.0|2.9|6.8||Comparison of HbA1c ≤6.5% at 52 weeks.|Regression, Logistic|||||6.8|2.9|<0.001
70864778|NCT00734474|141215181|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.5|3.5||Comparison of HbA1c ≤6.5% at 52 weeks.|Regression, Logistic|||||3.5|1.5|<0.001
70864779|NCT00734474|141215181|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.2|||<|0.001|TWO_SIDED|95.0|3.4|7.9||Comparison of HbA1c ≤6.5% at 104 weeks.|Regression, Logistic|||||7.9|3.4|<0.001
70864780|NCT00734474|141215181|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|||<|0.001|TWO_SIDED|95.0|1.5|3.7||Comparison of HbA1c ≤6.5% at 104 weeks.|Regression, Logistic|||||3.7|1.5|<0.001
70864781|NCT00942448|141215215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.2|||<|0.001|||||||ANCOVA|||"The sample size calculation was based on a hypothesis of superiority of diclofenac HPBCD s.c. 25mg/ml and 50 mg/ml compared to Placebo with regard to the primary efficacy variable (PID at 1.5 hours following drug administration).~A sample size of 60 in each group had 95% power to detect a difference between diclofenac HPBCD s.c. 25 mg/ml and placebo in means of 15 mm, assuming that the common standard deviation was 22.5 and using a two group t-test with a 0.05 two-sided significance level."||||< 0.001
70864782|NCT00942448|141215215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.1||||0.001|TWO_SIDED|95.0|18.4|31.7|||ANCOVA|||||31.7|18.4|0.001
70864783|NCT00942448|141215228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.2|||<|0.001|TWO_SIDED|95.0|17.6|30.8|||ANCOVA|||"The sample size calculation was based on a hypothesis of superiority of diclofenac HPBCD s.c. 25mg/ml and 50 mg/ml compared to Placebo with regard to the primary efficacy variable (PID at 1.5 hours following drug administration).~A sample size of 60 in each group had 95% power to detect a difference between diclofenac HPBCD s.c. 25 mg/ml and placebo in means of 15 mm, assuming that the common standard deviation was 22.5 and using a two group t-test with a 0.05 two-sided significance level."||30.8|17.6|< 0.001
70948181|NCT02660112|141397144|SUPERIORITY|||||||0.336|||||||Wilcoxon (Mann-Whitney)|||||||0.336
70948182|NCT00379769|141397237|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 1.2 for the upper limit of the 95 percent confidence interval in time to event analysis comparing RSG to MET/SU stratified by background medication|Hazard Ratio (HR)|0.99||||||95.0|0.85|1.16||||||||1.16|0.85|
70948183|NCT00379769|141397261|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||||95.0|0.68|1.08||||||||1.08|0.68|
70948184|NCT00379769|141397262|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||||95.0|0.78|1.17||||||||1.17|0.78|
70864784|NCT00942448|141215228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.1|||<|0.001|TWO_SIDED|95.0|18.4|31.7|||ANCOVA|||"The sample size calculation was based on a hypothesis of superiority of diclofenac HPBCD s.c. 25mg/ml and 50 mg/ml compared to Placebo with regard to the primary efficacy variable (PID at 1.5 hours following drug administration).~A sample size of 60 in each group had 95% power to detect a difference between diclofenac HPBCD s.c. 25 mg/ml and placebo in means of 15 mm, assuming that the common standard deviation was 22.5 and using a two group t-test with a 0.05 two-sided significance level."||31.7|18.4|<0.001
70864785|NCT03089320|141215229|SUPERIORITY||posterior mean proportion of abstinence|9.12|||||TWO_SIDED|95.0|0.08|31.68|||||The lower and upper limits are credible intervals.|Bayesian analysis was performed, therefore p value is not reported. Bayes factor has been reported instead.||31.68|0.08|
70864786|NCT03089320|141215230|SUPERIORITY||posterior mean proportion of abstinence|5.5|||||TWO_SIDED|95.0|0.17|18.23|||||The lower and upper limits are credible intervals.|Bayesian analysis was performed, therefore p value is not reported. Bayes factor has been reported instead.||18.23|0.17|
70864787|NCT03089320|141215231|SUPERIORITY||Mean Difference (Final Values)|-4.32|STANDARD_ERROR_OF_MEAN|2.84||0.05|TWO_SIDED|95.0|-9.97|1.34|||Mixed Models Analysis|||mixed effects model||1.34|-9.97|.05
70864788|NCT00573183|141215242|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.3404|STANDARD_ERROR_OF_MEAN|0.4134|<|0.05|TWO_SIDED|95.0|1.2019|9.2842||95% confidence interval|Mixed Models Analysis|A covariate adjustment was used: average number of days of stimulant use within a 30-day window of assessment from 90 days pre-baseline to baseline.|The STAGE-12 group represented the numerator and TAU represented the reference group/denominator|Mixture model with a logistic part for assessing zero-inflation and a negative binomial part for the over-dispersed count data, with corresponding 95% confidence intervals (CIs) of the odds ratios for logistic part and incidence rate ratios for negative binomial part.||9.2842|1.2019|<0.05
70864789|NCT00573183|141215242|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4373|STANDARD_ERROR_OF_MEAN|0.4134|<|0.01|TWO_SIDED|95.0|1.0131|5.8637|||Mixed Models Analysis|||||5.8637|1.0131|<0.01
70948185|NCT00379769|141397263|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||||95.0|0.79|1.18||||||||1.18|0.79|
71139484|NCT03084796|141778130|SUPERIORITY||Mean Difference (Final Values)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.67|-0.17|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.17|-0.67|<0.001
70864790|NCT00573183|141215243|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical Model - zero-inflated negative binomial random-effects regression|Zero-inflated negative binomial random-e|Statistical Model - zero-inflated negative binomial random-effects regression adjusted for average number of days of pre-baseline attendance||Outcome measure: Number of days of self-reported Self-Help meeting attendance by the Substance Use Calendar (SUC) within a 30-day window of assessment at mid-treatment, end-of-treatment, first, second, third and last follow-ups||||<0.05
70864791|NCT05027464|141215283|SUPERIORITY||Odds Ratio (OR)|1.249||||0.202|TWO_SIDED|95.0|0.888|1.759||Not adjusted for multiple comparisons; a priori threshold was P \< 0.05.|Regression, Logistic|Patient demographics were fixed effects, and randomization units with clinics nested within randomization units were random effects.|An odds ratio above one indicates favoring the intervention arm over the usual care arm.|Generalized linear mixed model to account for patient demographics and hierarchical levels for clinics nested within VAHCS. Null hypothesis is that both arms perform equivalently in vaccine uptake after a year. Power was based on recruited VAHCSs and at least 1,000 Veterans per clinic. Using two-sided 0.05 type I error rate, 5-20% outcome rate in UC, we have 90% power to detect between a 9.6% and 14.6% difference with a total sample size of 90,000 to 100,000.||1.759|0.888|0.202
70864792|NCT05027464|141215283|SUPERIORITY||Odds Ratio (OR)|1.228||||0.247|TWO_SIDED|95.0|0.867|1.738|||Regression, Logistic|||Sensitivity analysis, same null hypothesis and model as primary analysis but different pool of patients: Not constrained to Veterans with at least one primary care visit||1.738|0.867|0.247
70948186|NCT00379769|141397264|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||||95.0|0.68|1.21||||||||1.21|0.68|
70864793|NCT05027464|141215283|SUPERIORITY||Odds Ratio (OR)|1.263||||0.455|TWO_SIDED|95.0|0.684|2.334|||Regression, Logistic|||Sensitivity analysis; same model and null hypothesis but reassigning small clinics to their parent VAHCS facility, small meaning \< 100 participants. This data set uses the primary analysis data set with the primary visit constraint.||2.334|0.684|0.455
70948187|NCT00379769|141397265|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||||95.0|0.68|1.21||||||||1.21|0.68|
70948188|NCT00379769|141397266|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||||95.0|0.8|1.59||||||||1.59|0.80|
70864794|NCT05027464|141215283|SUPERIORITY||Odds Ratio (OR)|1.26||||0.364|TWO_SIDED|95.0|0.765|2.075|||Regression, Logistic|||Sensitivity Analysis: same model and null hypothesis as primary outcome but the source of vaccination records omits Medicare claims data. The primary data source had included Medicare claims data on vaccination records as a supplement to the VA data.||2.075|0.765|0.364
70864795|NCT05027464|141215283|SUPERIORITY||Odds Ratio (OR)|1.268||||0.168|TWO_SIDED|95.0|0.904|1.778|||Regression, Logistic|||"Sensitivity Analysis: same model and null hypothesis as primary analysis model but the source of data is supplemented by state level registries, named IZ Gateway, which was deployed summer of 2023 where Veteran records of vaccination could be updated at the VA from external vaccination facilities if the Veteran entered the VA in the same state as that vaccination facility. The primary analysis data contains Medicare claims data in this analysis, too."||1.778|0.904|0.168
70948189|NCT00379769|141397267|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||||95.0|0.82|1.62||||||||1.62|0.82|
70948190|NCT00379769|141397268|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||||95.0|0.54|1.14||||||||1.14|0.54|
70948191|NCT00379769|141397269|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||||95.0|0.57|1.18||||||||1.18|0.57|
70948192|NCT02820597|141397320|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|Paired t-tests on the mean change from baseline. No adjustments were made for multiple comparisons.||Null hypothesis is that the within-participant change from baseline in rTNSS is 0.||||<0.001
70948193|NCT02820597|141397321|SUPERIORITY||||||<|0.001||||||Paired t-tests on the mean change from baseline. No adjustments were made for multiple comparisons.|t-test, 2 sided|||Null hypothesis is that the within-participant change from baseline in rhinitis symptoms VAS is 0.||||<0.001
70864796|NCT05027464|141215284|SUPERIORITY||Odds Ratio (OR)|0.993||||0.976|TWO_SIDED|95.0|0.643|1.535||P \< 0.05 and no multiple comparison adjustment|Regression, Logistic|We adjusted for patient demographics as fixed effects and randomization units and associated clinics as a three-level random effect.|An odds ratio above one indicates favoring the intervention arm over the usual care arm.|Power calculation is similar to the calculation for the primary outcome. Null hypothesis is described in the outcome comparison related to this statistical analysis plan.||1.535|0.643|.976
70864797|NCT05027464|141215284|SUPERIORITY||Odds Ratio (OR)|0.978||||0.893|TWO_SIDED|95.0|0.702|1.361|||Regression, Logistic|GLMM||Sensitivity analysis, same null hypothesis and model as primary analysis but different pool of patients: Not constrained to Veterans with at least one primary care visit||1.361|0.702|0.893
70864798|NCT05027464|141215284|SUPERIORITY||Odds Ratio (OR)|0.961||||0.863|TWO_SIDED|95.0|0.613|1.507|||Regression, Logistic|GLMM||Sensitivity Analysis: same model and null hypothesis as primary outcome but the source of vaccination records omits Medicare claims data. The primary data source had included Medicare claims data on vaccination records as a supplement to the VA data.||1.507|0.613|0.863
70864799|NCT05027464|141215284|SUPERIORITY||Odds Ratio (OR)|1.011||||0.963|TWO_SIDED|95.0|0.636|1.607|||Regression, Logistic|GLMM||"Sensitivity Analysis: same model and null hypothesis as primary analysis model but the source of data is supplemented by state level registries, named IZ Gateway, which was deployed summer of 2023 where Veteran records of vaccination could be updated at the VA from external vaccination facilities if the Veteran entered the VA in the same state as that vaccination facility. The primary analysis data contains Medicare claims data in this analysis, too."||1.607|0.636|0.963
70864800|NCT05027464|141215285|SUPERIORITY||Odds Ratio (OR)|1.191||||0.395|TWO_SIDED|95.0|0.796|1.781||Threshold: P \< 0.05; not adjusted for multiple comparisons|Regression, Logistic|Generalized linear mixed modeling adjusted for baseline covariates and hierarchical levels for randomization units and clinics within them.|Odds ratio in favor of intervention arm (MI) has values higher than 1.|No power calculation for this exploratory outcome. Null hypothesis is that both arms will have equal uptake rates of the COVID-19 Booster vaccination during the study period.||1.781|0.796|0.395
70864801|NCT05027464|141215286|SUPERIORITY||Odds Ratio (OR)|1.128||||0.119|TWO_SIDED|95.0|0.97|1.311||P-value was not adjusted for multiple comparisons and the p-value threshold was \< 0.05.|Regression, Logistic|Generalized linear mixed model adjusting for baseline covariates and flu vaccine in prior year, with hierarchical random effects for ran. unit/site|Odds ratio in favor of novel intervention arm has values higher than 1|Null hypothesis is that both study arms will have equal rates of flu vaccination uptake during the study period. No power calculation since this outcome is exploratory.||1.311|0.97|0.119
70864802|NCT03270644|141215304|OTHER||Difference of LSMeans|-5.45|||||TWO_SIDED|90.0|-7.27|-3.64||||||Mean hourly HR was evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||-3.64|-7.27|
70948194|NCT00158197|141397329|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.98|||<|0.01|TWO_SIDED||||||Generalized estimating equations||Value represents the odds of submitting a methamphetamine negative urine sample in the treatment group (1 of 3) compared to the standard care group.|||||<0.01
70948195|NCT00158197|141397329|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|||<|0.01|||||||Generalized estimating equations||Value represents the odds of submitting a methamphetamine negative urine sample in the treatment group (1 of 3) compared to the standard care group.|||||<0.01
70864803|NCT03270644|141215305|OTHER||Ratio of Geometric LSMeans|0.884|||||TWO_SIDED|90.0|0.832|0.939||||||Log-transformed PK parameters were evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||0.939|0.832|
70864804|NCT03270644|141215306|OTHER||Ratio of Geometric LSMeans|0.958|||||TWO_SIDED|90.0|0.917|1.0||||||Ratio of geometric LSMeans of Cmax used a mixed-effects repeated measures model adjusted for fixed effects for treatment, time point, time point by treatment, and random effect for subjects.||1.00|0.917|
70864805|NCT03270644|141215307|OTHER||Ratio of Geometric LSMeans|1.01|||||TWO_SIDED|90.0|0.967|1.04||||||Log-transformed PK parameters were evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||1.04|0.967|
70948196|NCT00158197|141397329|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72|||<|0.01|||||||Generalized estimating equations||Value represents the odds of submitting a methamphetamine negative urine sample in the treatment group (1 of 3) compared to the standard care group.|||||<0.01
70948197|NCT00158197|141397330|SUPERIORITY_OR_OTHER|||||||0.02||||||Yes, the a priori plan to handle post hoc multiple comparisons was to use the method of Bonferroni adjustment. Thus, the new alpha level for these comparisons was \<0.0125.|ANOVA|||||||0.02
70948198|NCT00158197|141397330|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
70864806|NCT03270644|141215308|OTHER||Ratio of Geometric LSMeans|0.999|||||TWO_SIDED|90.0|0.967|1.03||||||Log-transformed PK parameters were evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||1.03|0.967|
70864807|NCT03270644|141215309|OTHER||Difference of LSMeans|-3.51|||||TWO_SIDED|90.0|-6.39|-0.64||||||PR interval was evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||-0.64|-6.39|
70864808|NCT03270644|141215310|OTHER||Difference of LSMeans|5.57|||||TWO_SIDED|90.0|3.57|7.57||||||Systolic blood pressure was evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||7.57|3.57|
70864809|NCT03270644|141215311|OTHER||Difference of LSMeans|3.47|||||TWO_SIDED|90.0|1.99|4.95||||||Diastolic blood pressure was evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||4.95|1.99|
70948199|NCT00158197|141397330|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
70948200|NCT00158197|141397330|SUPERIORITY_OR_OTHER|||||||0.2|||||||t-test, 2 sided|||||||0.20
70948201|NCT00158197|141397331|SUPERIORITY_OR_OTHER|||||||0.78|||||||Generalized estimating equations|||We used GEE to investigate change in methamphetamine abstinence (i.e., provision of a negative methamphetamine UA) during the follow-up period.||||0.78
70948202|NCT00158197|141397331|SUPERIORITY_OR_OTHER|||||||0.68|||||||Generalized estimating equations|||We used GEE to investigate change in methamphetamine abstinence (i.e., provision of a negative methamphetamine UA) during the follow-up period.||||0.68
70864810|NCT04066647|141215312|SUPERIORITY||Mean Difference (Final Values)|0.93928821||||0.9|TWO_SIDED||||||t-test, 2 sided|2 tailed, unpaired t test with Bonferroni correction||||||0.9
70864811|NCT01856907|141215328|SUPERIORITY|||||||0.035|||||||McNemar|||Study change from dysglycemia to normal glucose state||||.035
70864812|NCT01856907|141215329|SUPERIORITY|||||||0.044|||||||ANOVA|||Subjects (SS)/ Treatment Group x repeated measures (visit) design||||0.044
70864813|NCT01856907|141215330|SUPERIORITY|||||||0.034|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.034
70864814|NCT01856907|141215331|SUPERIORITY|||||||0.047|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||.047
70948203|NCT00158197|141397331|SUPERIORITY_OR_OTHER|||||||0.2|||||||Generalized estimating equations|||We used GEE to investigate change in methamphetamine abstinence (i.e., provision of a negative methamphetamine UA) during the follow-up period.||||0.20
70864815|NCT01856907|141215332|SUPERIORITY|||||||0.017|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.017
70864816|NCT01856907|141215333|SUPERIORITY|||||||0.014|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.014
70864817|NCT01856907|141215334|SUPERIORITY|||||||0.042|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.042
70864818|NCT01856907|141215335|SUPERIORITY|||||||0.002|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.002
70864819|NCT01856907|141215336|SUPERIORITY|||||||0.004|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.004
70948204|NCT02666664|141397346|SUPERIORITY||Difference in LS mean|-18.1|STANDARD_ERROR_OF_MEAN|1.01|<|0.001|TWO_SIDED|95.0|-20.0|-16.1|||ANCOVA|||||-16.1|-20|<0.001
70948205|NCT02666664|141397348|SUPERIORITY||Difference in LS mean|-16.1|STANDARD_ERROR_OF_MEAN|1.07|<|0.001|TWO_SIDED|95.0|-18.2|-14.0|||ANCOVA|||||-14|-18.2|<0.001
71139485|NCT03084796|141778130|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.016|TWO_SIDED|95.0|-0.55|-0.06|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.06|-0.55|0.016
70864820|NCT01856907|141215337|SUPERIORITY|||||||0.004|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.004
70864821|NCT01856907|141215338|SUPERIORITY|||||||0.9|||||||Fisher Exact|||||||0.9
70864822|NCT01604408|141215344|SUPERIORITY_OR_OTHER||LS Mean Difference|0.426|||<|0.001|TWO_SIDED|95.0|0.192|0.66|||Mixed Model Repeated Measures|||||0.660|0.192|<0.001
70864823|NCT01604408|141215345|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.461||||0.073|TWO_SIDED|90.0|-0.883|-0.039|||Mixed Model Repeated Measures|||||-0.039|-0.883|0.073
70864824|NCT01604408|141215346|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.062||||0.191|TWO_SIDED|90.0|-2.4|0.276|||Mixed Model Repeated Measures|||||0.276|-2.400|0.191
70864825|NCT01604408|141215347|SUPERIORITY_OR_OTHER||LS Mean Difference|0.017||||0.478|TWO_SIDED|90.0|-0.023|0.057|||Mixed Model Repeated Measures|||||0.057|-0.023|0.478
70864826|NCT02437383|141215378|SUPERIORITY||LSM Difference (Final Values)|-1.8||||0.414|TWO_SIDED|95.0|-6.2|2.6||P-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05.|Mixed Models Analysis|Covariates for site, baseline value, sex, race, treatment, visit, a treatment\*visit interaction, and an unstructured covariance structure.||||2.6|-6.2|0.414
70864827|NCT01453725|141215455|SUPERIORITY_OR_OTHER||Difference in Percent vs Placebo|31.2|||<|0.0001|TWO_SIDED|95.0|17.5|43.6||Stratification factors: Baseline evidence of sacroiliitis on magnetic resonance imaging (MRI) and Screening C-reactive protein (CRP) level|Stratified Miettinen and Nurminen Method|||||43.6|17.5|<0.0001
70864828|NCT01453725|141215456|SUPERIORITY_OR_OTHER||Difference in Percent vs Placebo|33.8|||<|0.0001|TWO_SIDED|95.0|20.4|46.1||Stratification factors: Baseline evidence of sacroiliitis on MRI and Screening CRP level|Stratified Miettinen and Nurminen Method|||||46.1|20.4|<0.0001
70864829|NCT01453725|141215457|SUPERIORITY_OR_OTHER||Difference in Percent vs Placebo|28.0|||<|0.0001|TWO_SIDED|95.0|14.4|40.6||Stratification factors: Baseline evidence of sacroiliitis on MRI and Screening CRP level|Stratified Miettinen and Nurminen Method|||||40.6|14.4|<0.0001
70864830|NCT01453725|141215458|SUPERIORITY_OR_OTHER||Difference in Percent vs Placebo|15.2||||0.0136|TWO_SIDED|95.0|3.2|27.1||Stratification factors: Baseline evidence of sacroiliitis on MRI and Screening CRP level|Stratified Miettinen and Nurminen Method|||||27.1|3.2|0.0136
70864831|NCT01453725|141215459|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mann-Whitney Test|||||||<0.0001
70864832|NCT00471146|141215506|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.014||||0.5436|TWO_SIDED|95.0|0.786|1.309||One-sided log-rank test at alpha = 0.025 significance level was used.|Log Rank|||Differences in OS between treatment arms was analyzed by 1-sided log rank test, stratified for extent of disease (locally advanced cancer versus metastatic cancer).||1.309|0.786|0.5436
70864833|NCT00471146|141215507|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.006||||0.5203|TWO_SIDED|95.0|0.779|1.298||One-sided log-rank test at alpha = 0.025 significance level was used.The p-value was not adjusted for multiple testing.|Log Rank|||Differences in PFS between treatment arms was analyzed by 1-sided log rank test, stratified for extent of disease (locally advanced cancer versus metastatic cancer).||1.298|0.779|0.5203
70864834|NCT00471146|141215508|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.2||||0.038|TWO_SIDED|95.0|1.0|10.1|||Cochran-Mantel-Haenszel|||Differences in OR between treatment arms was analyzed by 1-sided Cochran-Mantel-Haenszel (CMH) test, stratified for extent of disease (locally advanced cancer versus metastatic cancer).||10.1|1.0|0.038
70948206|NCT02666664|141397349|SUPERIORITY||Difference in LS mean|-13.3|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-15.1|-11.6|||ANCOVA|||||-11.6|-15.1|<0.001
70948207|NCT02666664|141397350|SUPERIORITY||Difference in LS mean|-11.1|STANDARD_ERROR_OF_MEAN|0.69|<|0.001|TWO_SIDED|95.0|-12.5|-9.8|||ANCOVA|||||-9.8|-12.5|<0.001
70948208|NCT02666664|141397351|SUPERIORITY||Difference in LS mean|-11.9|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|95.0|-13.6|-10.2|||ANCOVA|||||-10.2|-13.6|<0.001
70948209|NCT02666664|141397352|SUPERIORITY||Location shift|-21.5|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-26.96|-16.0|||Wilcoxon (Mann-Whitney)|||||-16|-26.96|<0.001
70948210|NCT02666664|141397353|SUPERIORITY||Difference in LS mean|-13.6|STANDARD_ERROR_OF_MEAN|1.13|<|0.001|TWO_SIDED|95.0|-15.8|-11.3|||ANCOVA|||||-11.3|-15.8|<0.001
70948211|NCT02666664|141397362|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
70948212|NCT01385748|141397376|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.677||||0.165|TWO_SIDED|95.0|0.387|1.186|||Log Rank|The log rank test at 5% significance level was used.||||1.186|0.387|0.165
70948213|NCT01385748|141397376|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.817||||0.421|TWO_SIDED|95.0|0.495|1.35|||Log Rank|The log rank test at 5% significance level was used.||||1.35|0.495|0.421
70948214|NCT01385748|141397376|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.754||||0.211|TWO_SIDED|95.0|0.484|1.175|||Log Rank|The log rank test at 5% significance level was used.||||1.175|0.484|0.211
70948215|NCT01385748|141397379|SUPERIORITY_OR_OTHER|||||||0.807||||||Significance threshold = 5%|Wilcoxon (Mann-Whitney)|||||||0.807
70948216|NCT01385748|141397379|SUPERIORITY_OR_OTHER|||||||0.971||||||Significance threshold = 5%|Wilcoxon (Mann-Whitney)|||||||0.971
71139486|NCT03084796|141778130|SUPERIORITY||Mean Difference (Final Values)|-0.29||||0.025|TWO_SIDED|95.0|-0.54|-0.04|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.04|-0.54|0.025
71139487|NCT03084796|141778130|SUPERIORITY||Mean Difference (Final Values)|-0.47|||<|0.001|TWO_SIDED|95.0|-0.72|-0.22|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.22|-0.72|<0.001
70948217|NCT01385748|141397381|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.698||||0.199|TWO_SIDED|95.0|0.398|1.223||Significance threshold = 5%|Log Rank|||||1.223|0.398|0.199
70948218|NCT01385748|141397381|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.817||||0.424|TWO_SIDED|95.0|0.493|1.353|||Log Rank|Significance threshold = 5%||||1.353|0.493|0.424
70948219|NCT01385748|141397381|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.764||||0.235|TWO_SIDED|95.0|0.489|1.193|||Log Rank|Significance threshold = 5%||||1.193|0.489|0.235
70948220|NCT01385748|141397382|SUPERIORITY_OR_OTHER|||||||0.176|||||||Kruskal-Wallis|Significance threshold = 5%||||||0.176
70948221|NCT01385748|141397382|SUPERIORITY_OR_OTHER|||||||0.61|||||||Kruskal-Wallis|Significance threshold = 5%||||||0.61
70948222|NCT01385748|141397382|SUPERIORITY_OR_OTHER|||||||0.295|||||||Kruskal-Wallis|Significance threshold = 5%||||||0.295
70948223|NCT01385748|141397383|SUPERIORITY_OR_OTHER|||||||0.063||||||Significance threshold = 5%|Chi-squared|||||||0.063
70948224|NCT01385748|141397383|SUPERIORITY_OR_OTHER|||||||0.169|||||||Chi-squared|||||||0.169
70948225|NCT01385748|141397383|SUPERIORITY_OR_OTHER|||||||0.064|||||||Chi-squared|Significance threshold = 5%||||||0.064
70948226|NCT01385748|141397384|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.824||||0.388|TWO_SIDED|95.0|0.484|1.401|||Log Rank|Significance threshold = 5%||||1.401|0.484|0.388
70948227|NCT01385748|141397384|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.601||||0.054|TWO_SIDED|95.0|0.357|1.012|||Log Rank|Significance threshold = 5%||||1.012|0.357|0.054
70948228|NCT01385748|141397384|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.692||||0.102|TWO_SIDED|95.0|0.444|1.078|||Log Rank|Significance threshold = 5%||||1.078|0.444|0.102
70948229|NCT01458522|141397414|OTHER|||||||0.512|||||||Poisson regression model|||||||0.512
71139488|NCT03084796|141778130|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.083|TWO_SIDED|95.0|-0.48|0.03|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.03|-0.48|0.083
71139489|NCT03084796|141778130|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.355|TWO_SIDED|95.0|-0.13|0.36|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.36|-0.13|0.355
71139490|NCT03084796|141778130|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.283|TWO_SIDED|95.0|-0.11|0.38|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.38|-0.11|0.283
71139491|NCT03084796|141778130|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.712|TWO_SIDED|95.0|-0.29|0.2|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.20|-0.29|0.712
71139492|NCT03084796|141778130|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.877|TWO_SIDED|95.0|-0.23|0.27|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.27|-0.23|0.877
71139493|NCT03084796|141778130|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.195|TWO_SIDED|95.0|-0.41|0.08|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.08|-0.41|0.195
71139494|NCT03084796|141778130|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.15|TWO_SIDED|95.0|-0.43|0.07|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.07|-0.43|0.150
71139495|NCT03084796|141778131|SUPERIORITY||Mean Difference (Final Values)|-0.967||||0.016|TWO_SIDED|95.0|-1.753|-0.181|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, inter-visit period, treatment by inter-visit period interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by inter-visit period interaction as covariates."||-0.181|-1.753|0.016
70864835|NCT02478372|141215518|SUPERIORITY_OR_OTHER|||||||0.332|TWO_SIDED|||||Significance was set at \<0.01|Chi-squared|||||||0.332
70864836|NCT03800173|141215533|OTHER||Slope|0.982|||||TWO_SIDED|90.0|0.868|1.096||||||A model with In-transformed dose (dose continuous) as a fixed effect \& subject as a random effect was applied to In-transformed Cmax. Dose proportionality was assessed by restricted max likelihood using SAS PROC MIXED. The mean slope was estimated from the power model \& the corresponding 90% CI calculated. Although there was no formal statistical hypothesis tested for this secondary objective, there was evidence for dose proportionality if the 90% CI of the fixed slope for In-dose contained 1.||1.096|0.868|
70864837|NCT03800173|141215534|OTHER||Slope|1.0|||||TWO_SIDED|90.0|0.872|1.128||||||A model with In-transformed dose (dose continuous) as a fixed effect \& subject as a random effect was applied to In-transformed AUC0-inf Dose proportionality was assessed by restricted max likelihood using SAS PROC MIXED. The mean slope was estimated from the power model \& the corresponding 90% CI calculated. Although there was no formal statistical hypothesis tested for this secondary objective, there was evidence for dose proportionality if the 90% CI of the fixed slope for In-dose contained 1||1.128|0.872|
70864838|NCT03800173|141215534|OTHER||Slope|1.086|||||TWO_SIDED|90.0|0.952|1.219||||||A model with In-transformed dose (dose continuous) as a fixed effect \& subject as a random effect was applied to In-transformed AUC0-t. Dose proportionality was assessed by restricted max likelihood using SAS PROC MIXED. The mean slope was estimated from the power model \& the corresponding 90% CI calculated. Although there was no formal statistical hypothesis tested for this secondary objective, there was evidence for dose proportionality if the 90% CI of the fixed slope for In-dose contained 1.||1.219|0.952|
70864839|NCT00910273|141215537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.72||||0.608|TWO_SIDED|95.0|-5.14|8.58|||Mixed Models Analysis|||"Null Hypothesis: No difference in Change in FMD at 12 weeks for Etanercept and placebo.~Alternative Hypothesis: Difference in Change in FMD at 12 weeks for Etanercept and placebo.~Sample size of 36 subjects per treatment arm was planned based on an expected difference of 0.9 in FMD (Standard Deviation \[SD\] 1.5), with 80% power and 5% significance level."||8.58|-5.14|0.608
70864840|NCT00910273|141215538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.82||||0.476|TWO_SIDED|95.0|-3.35|7.0|||Mixed Models Analysis||Analyses available for Week 4 only, due to limited number of participants for Week 24 to Week 52.|Week 4||7.00|-3.35|0.476
70864841|NCT00910273|141215539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.65|TWO_SIDED|95.0|-0.08|0.13|||ANCOVA|||Week 12; Common Carotid Artery; Due to limited number of participants with visits after Week 12 analysis limited to Week 12||0.13|-0.08|0.650
70948230|NCT03382561|141397450|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.17|TWO_SIDED|95.0|0.55|1.11|||Log Rank||Hazard ratio: Arm A (CEN)/Arm B (CE)|||1.11|0.55|0.17
70948231|NCT03121820|141397456|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric mean ratios were fully contained within the predefined equivalence limits of 80.00 % to 125.00 %|Test/Ref Geometric mean ratio x 100|93.8||||0.05|TWO_SIDED|90.0|88.25|99.77|||Test/Ref Geometric mean ratio x 100|Bioequivalence is established when 90% Confidence Interval falls within 80.00 % -125.00 %.||Memantinol 20 mg Tablets Versus Akatinol Memantine® 20 mg||99.77|88.25|0.05
70948232|NCT03121820|141397457|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric mean ratios were fully contained within the predefined equivalence limits of 80.00 % to 125.00 %|Test/Ref Geometric mean ratio x 100|92.3||||0.05|TWO_SIDED|90.0|86.37|98.55|||Test/Ref Geometric mean ratio x 100|Bioequivalence is established when 90% Confidence Interval falls within 80.00 % -125.00 %.||Memantinol 20 mg Tablets Versus Akatinol Memantine® 20 mg||98.55|86.37|0.05
70864842|NCT00910273|141215539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.513|TWO_SIDED|95.0|-0.13|0.07|||ANCOVA|||Week 12; Common Bulb; Due to limited number of participants with visits after Week 12 analysis limited to Week 12||0.07|-0.13|0.513
70864843|NCT00910273|141215539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.592|TWO_SIDED|95.0|-0.14|0.08|||ANCOVA|||Week 12; Internal Carotid Artery; Due to limited number of participants with visits after Week 12 analysis limited to Week 12||0.08|-0.14|0.592
70864844|NCT00910273|141215544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.77||||0.008|TWO_SIDED|95.0|-3.05|-0.5|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 4||-0.50|-3.05|0.008
70864845|NCT00910273|141215544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.02||||0.021|TWO_SIDED|95.0|-3.7|-0.33|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 12||-0.33|-3.70|0.021
70864846|NCT00910273|141215552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07||||0.003|TWO_SIDED|95.0|-1.74|-0.4|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 4||-0.40|-1.74|0.003
70864847|NCT00910273|141215552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91||||0.029|TWO_SIDED|95.0|-1.72|-0.1|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 12||-0.10|-1.72|0.029
70864848|NCT00910273|141215558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09||||0.041|TWO_SIDED|95.0|-2.13|-0.05|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 4||-0.05|-2.13|0.041
70864849|NCT00910273|141215558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.048|TWO_SIDED|95.0|-2.55|-0.01|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 12||-0.01|-2.55|0.048
70864850|NCT00910273|141215559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.575|TWO_SIDED|95.0|-0.89|1.57|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 4||1.57|-0.89|0.575
70864851|NCT00910273|141215559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.204|TWO_SIDED|95.0|-0.52|2.3|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 12||2.30|-0.52|0.204
70864852|NCT03841448|141215560|SUPERIORITY||Placebo-adjusted GM Percent Change|-37.367||||0.1032|TWO_SIDED|90.0|-60.951|0.46|||MMRM||Placebo-adjusted GM percent change, 90% CIs were calculated by exponentially back-transforming the model based LS mean difference (cemdisiran - placebo) and the corresponding 90% CI then subtracting by 1.|||0.460|-60.951|0.1032
70864853|NCT03841448|141215561|SUPERIORITY||Placebo-adjusted GM Percent Change|-36.167||||0.1432|TWO_SIDED|90.0|-61.552|5.978|||MMRM||Placebo-adjusted GM percent change, 90% CIs were calculated by exponentially back-transforming the model based LS mean difference (cemdisiran - placebo) and the corresponding 90% CI then subtracting by 1.|||5.978|-61.552|0.1432
70864854|NCT03841448|141215562|SUPERIORITY||Odds Ratio (OR)|3.01||||0.1177|TWO_SIDED|90.0|0.43|21.27|||Cochran-Mantel-Haenszel|p-value was based on Cochran-Mantel-Haenszel test stratified by baseline 24-hour UP (≥1.0 g and \<2 g/day versus ≥2.0 g/day).|Odds ratio was estimated with logit method using a correction of 0.5 in every cell of the 2x2 table that contains a zero.|||21.27|0.43|0.1177
70864855|NCT03841448|141215562|SUPERIORITY||Difference in Proportions|0.23|||||TWO_SIDED|90.0|-0.13|0.42|||||Difference in proportions (cemdisiran - placebo) (90% CI) was based on the Wilson score method with continuity correction.|||0.42|-0.13|
70864856|NCT03841448|141215563|SUPERIORITY||Odds Ratio (OR)|3.02||||0.1533|TWO_SIDED|90.0|0.45|20.34|||Cochran-Mantel-Haenszel|p-value was based on Cochran-Mantel-Haenszel test stratified by baseline 24-hour UP (≥1.0 g and \<2 g/day versus ≥2.0 g/day).|Odds ratio was estimated with logit method using a correction of 0.5 in every cell of the 2x2 table that contains a zero.|||20.34|0.45|0.1533
70864857|NCT03841448|141215563|SUPERIORITY||Difference in Proportions|0.23|||||TWO_SIDED|90.0|-0.13|0.42|||||Difference in proportions (cemdisiran - placebo) (90% CI) was based on the Wilson score method with continuity correction.|||0.42|-0.13|
70864858|NCT03841448|141215564|SUPERIORITY||Placebo-adjusted GM Percent Change|-45.771||||0.0021|TWO_SIDED|90.0|-60.093|-26.309|||MMRM||Placebo-adjusted GM percent change, 90% CIs were calculated by exponentially back-transforming the model based LS means difference (cemdisiran - placebo) and the corresponding 90% CI then subtracting by 1.|||-26.309|-60.093|0.0021
70864859|NCT00543543|141215567|SUPERIORITY_OR_OTHER||Vaccine efficacy|96.7|||<|0.0001|TWO_SIDED|95.0|80.9|99.8|||Exact test, 1-sided||Vaccine efficacy = 100 \* \[1 - (incidence rate with V503 / incidence rate with Gardasil)\]. The pre-specified success criterion was a lower bound of the 95% confidence interval of observed efficacy of \>25%.|||99.8|80.9|<0.0001
70864860|NCT00543543|141215568|SUPERIORITY_OR_OTHER||Vaccine efficacy|97.4|||||TWO_SIDED|95.0|85.0|99.9|||Exact test, 1-sided||Vaccine efficacy = 100 \* \[1 - (incidence rate with V503 / incidence rate with Gardasil)\]. The pre-specified success criterion was a lower bound of the 95% confidence interval of observed efficacy of \>25%.|||99.9|85.0|
70864861|NCT00543543|141215569|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.67|GMT ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.99|1.06|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|Anti-HPV Type 6||1.06|0.99|<0.001
70864862|NCT00543543|141215569|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided CI of the GMT ratio was \>0.67|GMT ratio|0.8|||<|0.001|TWO_SIDED|95.0|0.77|0.83|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|Anti-HPV Type 11||0.83|0.77|<0.001
70864863|NCT00543543|141215569|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided CI of the GMT ratio was \>0.67|GMT ratio|0.99|||<|0.001|TWO_SIDED|95.0|0.96|1.03|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|Anti-HPV Type 16||1.03|0.96|<0.001
70864864|NCT00543543|141215569|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided CI of the GMT ratio was \>0.67|GMT ratio|1.19|||<|0.001|TWO_SIDED|95.0|1.14|1.23|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|Anti-HPV Type 18||1.23|1.14|<0.001
70864865|NCT00543543|141215576|SUPERIORITY_OR_OTHER||Vaccine efficacy|96.0|||||TWO_SIDED|95.0|94.6|97.1|||||Vaccine efficacy = 100 \* \[1 - (incidence rate with V503 / incidence rate with Gardasil)\]. The pre-specified success criterion was a lower bound of the 95% confidence interval of observed efficacy of \>25%.|||97.1|94.6|
70864866|NCT01361568|141215580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.96|STANDARD_ERROR_OF_MEAN|3.64|<|0.05|TWO_SIDED|95.0|-15.14|-0.78|||t-test, 2 sided|||||-0.78|-15.14|<0.05
70864867|NCT01361568|141215581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-420.0|STANDARD_ERROR_OF_MEAN|139.16|<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
70864868|NCT01361568|141215581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-230.1|STANDARD_ERROR_OF_MEAN|92.26|<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
70864869|NCT01361568|141215581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-260.4|STANDARD_ERROR_OF_MEAN|141.99||0.068||95.0|||||t-test, 2 sided|||||||0.068
70864870|NCT01361568|141215582|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.39|STANDARD_ERROR_OF_MEAN|2.63|<|0.05||95.0|||||Mixed Models Analysis|||||||<0.05
70864871|NCT01361568|141215582|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.31|STANDARD_ERROR_OF_MEAN|1.74||0.059||95.0|||||Mixed Models Analysis|||||||0.059
70864872|NCT01361568|141215583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.41|<|0.05|TWO_SIDED|95.0|0.22|1.82|||t-test, 2 sided|||||1.82|0.22|<0.05
70864873|NCT01361568|141215583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.27|<|0.05|TWO_SIDED|95.0|0.11|1.17|||t-test, 2 sided|||||1.17|0.11|<0.05
70864874|NCT01361568|141215584|SUPERIORITY_OR_OTHER|||||||0.001|||||||Chi-squared|Degrees of freedom (df = 1)||||||0.001
70864875|NCT01361568|141215585|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
70864876|NCT01361568|141215586|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher Exact|||||||<0.05
70864877|NCT02959983|141215587|SUPERIORITY|||||||0.0022|||||||Chi-squared|||Overall Weeks 1-12||||0.0022
70864878|NCT02959983|141215588|SUPERIORITY|||||||0.0119|||||||Chi-squared|||Overall Weeks 1 to 12||||0.0119
70864879|NCT02959983|141215588|SUPERIORITY|||||||0.0048|||||||Chi-squared|||Weeks 1 to 4||||0.0048
70864880|NCT02959983|141215588|SUPERIORITY|||||||0.0207|||||||Chi-squared|||Weeks 5 to 8||||0.0207
70864881|NCT02959983|141215588|SUPERIORITY|||||||0.37|||||||Chi-squared|||Weeks 9 to 12||||0.3700
70864882|NCT02959983|141215589|SUPERIORITY|||||||0.0174|||||||Chi-squared|||Overall Weeks 1 to 12||||0.0174
70864883|NCT02959983|141215589|SUPERIORITY|||||||0.3832|||||||Chi-squared|||Weeks 1 to 4||||0.3832
70864884|NCT02959983|141215589|SUPERIORITY|||||||0.0052|||||||Chi-squared|||Weeks 5 to 8||||0.0052
70864885|NCT02959983|141215589|SUPERIORITY|||||||0.0619|||||||Chi-squared|||Weeks 9 to 12||||0.0619
70864886|NCT02959983|141215590|SUPERIORITY|||||||0.033|||||||Chi-squared|||Weeks 1-4||||0.0330
70864887|NCT02959983|141215590|SUPERIORITY|||||||0.0063|||||||Chi-squared|||Weeks 5 to 8||||0.0063
70864888|NCT02959983|141215590|SUPERIORITY|||||||0.0018|||||||Chi-squared|||Weeks 9 to 12||||0.0018
70864889|NCT00165984|141215599|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.9||||0.003|TWO_SIDED|95.0|1.7|13.9|||Regression, Cox|||||13.9|1.7|0.003
70864890|NCT02130024|141215660|OTHER||Treatment Effect|0.08||||0.236|TWO_SIDED|95.0|-0.05|0.21|||Mixed Models Analysis|Fixed effects: Baseline GA area, treatment, visit, treatment by visit. Random effect: Subject||||0.21|-0.05|0.236
70864891|NCT02130024|141215661|OTHER||Treatment Effect|0.02||||0.769|TWO_SIDED|95.0|-0.11|0.15|||Mixed Models Analysis|Fixed effects: Baseline GA area, treatment, visit, treatment by visit. Random effect: Subject||||0.15|-0.11|0.769
70864892|NCT02130024|141215662|OTHER||Odds Ratio (OR)|0.84||||0.586|TWO_SIDED|95.0|0.44|1.59|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment|Odds ratio of 'Newly Developed GA (Yes)' at between the two treatment groups at study visit|Baseline to Month 12 Analysis||1.59|0.44|0.586
70864893|NCT02130024|141215662|OTHER||Odds Ratio (OR)|2.27||||0.11|TWO_SIDED|95.0|0.83|6.22|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment|Odds ratio of 'Newly Developed GA (Yes)' at between the two treatment groups at study visit|Month 12 to Month 24 Analysis||6.22|0.83|0.110
70864894|NCT02130024|141215662|OTHER||Odds Ratio (OR)|1.19||||0.554|TWO_SIDED|95.0|0.67|2.09|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment||Baseline to Month 24 Analysis||2.09|0.67|0.554
70864895|NCT02130024|141215663|OTHER||Treatment Effect|0.99||||0.733|TWO_SIDED|95.0|0.95|1.04|||Negative Binomial Regression Model|Log (number of injections) = treatment + log (year of follow-up) (offset)|Treatment effect: Injection frequency (rate) ratio of Ranibizumab vs. Aflibercept|Baseline to \<Month 12 Analysis||1.04|0.95|0.733
71139496|NCT03084796|141778131|SUPERIORITY||Mean Difference (Final Values)|-0.824||||0.039|TWO_SIDED|95.0|-1.606|-0.043|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.043|-1.606|0.039
70864896|NCT02130024|141215663|OTHER||Treatment Effect|1.01||||0.745|TWO_SIDED|95.0|0.95|1.08|||Negative Binomial Regression Model|Log (number of injections) = treatment + log (year of follow-up) (offset)|Treatment effect: Injection frequency (rate) ratio of Ranibizumab vs. Aflibercept|Baseline to Month 24 Analysis||1.08|0.95|0.745
70864897|NCT02130024|141215664|OTHER||Treatment Effect|2.32||||0.079|TWO_SIDED|95.0|-0.27|4.92|||Mixed Models Analysis|Fixed effects: Baseline BCVA, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from baseline in BCVA|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Month 12 Analysis||4.92|-0.27|0.079
70864898|NCT02130024|141215664|OTHER||Treatment Effect|1.95||||0.151|TWO_SIDED|95.0|-0.71|4.61|||Mixed Models Analysis|Fixed effects: Baseline BCVA, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from baseline in BCVA|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Month 24 Analysis||4.61|-0.71|0.151
70864899|NCT02130024|141215665|OTHER||Treatment Effect|10.12||||0.294|TWO_SIDED|95.0|-8.82|29.06|||Mixed Models Analysis|Fixed effects: Baseline CSFT, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from baseline in CSFT|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Month 12 Analysis||29.06|-8.82|0.294
70864900|NCT02130024|141215665|OTHER||Treatment Effect|11.86||||0.225|TWO_SIDED|95.0|-7.35|31.07|||Mixed Models Analysis|Fixed effects: Baseline CSFT, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from baseline in CSFT|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Month 24 Analysis||31.07|-7.35|0.225
70864901|NCT02130024|141215666|OTHER||Odds Ratio (OR)|0.83||||0.461|TWO_SIDED|95.0|0.51|1.35|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment|Odds ratio of no IRF/SRF present between the two treatment groups at study visit|Month 2 Analysis||1.35|0.51|0.461
70864902|NCT02130024|141215666|OTHER||Odds Ratio (OR)|0.72||||0.215|TWO_SIDED|95.0|0.44|1.21|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment|Odds ratio of no IRF/SRF present between the two treatment groups at study visit|Month 12 Analysis||1.21|0.44|0.215
70864903|NCT02130024|141215666|OTHER||Odds Ratio (OR)|0.87||||0.616|TWO_SIDED|95.0|0.51|1.48|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment|Odds ratio of no IRF/SRF present between the two treatment groups at study visit|Month 24 Analysis||1.48|0.51|0.616
70864904|NCT02130024|141215667|OTHER||Odds Ratio (OR)|1.05||||0.891|TWO_SIDED|95.0|0.53|2.08|||Regression, Logistic|Includes treatment as factor and baseline BCVA as covariate. Model: log(p/1-p) =Treatment|Odds ratio of BCVA change from baseline ≥15 letters between the two treatment groups at study visit|Baseline to Month 12 Analysis||2.08|0.53|0.891
70864905|NCT02130024|141215667|OTHER||Odds Ratio (OR)|1.61||||0.206|TWO_SIDED|95.0|0.77|3.35|||Regression, Logistic|Includes treatment as factor and baseline BCVA as covariate. Model: log(p/1-p) =Treatment|Odds ratio of BCVA change from baseline ≥15 letters between the two treatment groups at study visit|Baseline to Month 24 Analysis||3.35|0.77|0.206
70864906|NCT02130024|141215668|OTHER||Odds Ratio (OR)|1.63||||0.46|TWO_SIDED|95.0|0.45|5.93|||Regression, Logistic|Includes treatment as factor and baseline BCVA as covariate. Model: log(p/1-p) =Treatment|Odds ratio of BCVA change from baseline ≥ -15 letters between the two treatment groups at study visit|Baseline to Month 12 Analysis||5.93|0.45|0.460
70864907|NCT02130024|141215668|OTHER||Odds Ratio (OR)|0.94||||0.913|TWO_SIDED|95.0|0.3|2.9|||Regression, Logistic|Includes treatment as factor and baseline BCVA as covariate. Model: log(p/1-p) =Treatment|Odds ratio of BCVA change from baseline ≥ -15 letters between the two treatment groups at study visit|Baseline to Month 24 Analysis||2.90|0.30|0.913
70864908|NCT02130024|141215670|OTHER||Treatment Effect|27.2|||<|0.001|TWO_SIDED|95.0|21.44|32.95|||Mixed Models Analysis|Fixed: BL Plasma VEGF, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from BL in Plasma VEGF|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Week 5 Analysis||32.95|21.44|<0.001
70864909|NCT02130024|141215670|OTHER||Treatment Effect|28.88|||<|0.001|TWO_SIDED|95.0|23.08|34.68|||Mixed Models Analysis|Fixed: BL Plasma VEGF, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from BL in Plasma VEGF|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Week 9 Analysis||34.68|23.08|<0.001
70864910|NCT00546104|141215713|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|9.0||0.3|TWO_SIDED|95.0|-30.0|9.0||The p-value is from a paired t-test to test the null hypothesis the mean relative change in Src from baseline to 4 weeks is equal to zero.|t-test, 2 sided|||The median change in SRC from baseline to 4 weeks was estimated.||9|-30|0.3
70948233|NCT02270671|141397461|SUPERIORITY_OR_OTHER||||||>|0.05||||||Group x Time interaction p-value: \>.05; Gender p-value: \>.05|ANOVA|2x2x3 repeated measures ANOVA. 2 between-subjects factors (Group; Gender) and 1 within-subject factor (Time). P value adjusted to p \< .025.||||||>.05
70948234|NCT02270671|141397462|SUPERIORITY_OR_OTHER||||||>|0.05||||||Group x Time interaction p-value: \>.05; Gender p-value: =.026|ANOVA|2x2x3 repeated measures ANOVA. 2 between-subjects factors (Group; Gender) and 1 within-subject factor (Time). P value adjusted to p \< .025.||||||>.05
70948235|NCT02270671|141397463|SUPERIORITY_OR_OTHER||||||>|0.05||||||Group x Time interaction p-value: \>.05; Gender p-value: \>.05|ANOVA|2x2x3 repeated measures ANOVA. 2 between-subjects factors (Group; Gender) and 1 within-subject factor (Time). P value adjusted to p \< .025.||||||>.05
70948236|NCT02270671|141397464|SUPERIORITY_OR_OTHER||||||>|0.05||||||Group x Time interaction p-value: \>.05; Gender p-value: \<.0001|ANOVA|2x2x3 repeated measures ANOVA. 2 between-subjects factors (Group; Gender) and 1 within-subject factor (Time). P value adjusted to p \< .025.||||||>.05
70948237|NCT02270671|141397465|SUPERIORITY_OR_OTHER||||||>|0.05||||||Group x Time interaction p-value: \>.05; Gender p-value: =.007|ANOVA|2x2x3 repeated measures ANOVA. 2 between-subjects factors (Group; Gender) and 1 within-subject factor (Time). P value adjusted to p \< .025.||||||>.05
70948238|NCT00476242|141397467|SUPERIORITY_OR_OTHER|||||||0.047|||||||Log Rank|||||||.047
71139497|NCT03084796|141778131|SUPERIORITY||Mean Difference (Final Values)|-1.227||||0.002|TWO_SIDED|95.0|-2.012|-0.441|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.441|-2.012|0.002
71139498|NCT03084796|141778131|SUPERIORITY||Mean Difference (Final Values)|-0.949||||0.018|TWO_SIDED|95.0|-1.733|-0.164|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.164|-1.733|0.018
71139499|NCT03084796|141778131|SUPERIORITY||Mean Difference (Final Values)|-0.566||||0.169|TWO_SIDED|95.0|-1.374|0.242|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.242|-1.374|0.169
71139500|NCT03084796|141778131|SUPERIORITY||Mean Difference (Final Values)|0.142||||0.72|TWO_SIDED|95.0|-0.638|0.923|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.923|-0.638|0.720
71139501|NCT03084796|141778131|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.515|TWO_SIDED|95.0|-1.043|0.523|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.523|-1.043|0.515
71139502|NCT03084796|141778131|SUPERIORITY||Mean Difference (Final Values)|0.018||||0.963|TWO_SIDED|95.0|-0.764|0.8|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.800|-0.764|0.963
71139503|NCT03084796|141778131|SUPERIORITY||Mean Difference (Final Values)|-0.402||||0.311|TWO_SIDED|95.0|-1.182|0.377|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.377|-1.182|0.311
71139504|NCT03084796|141778131|SUPERIORITY||Mean Difference (Final Values)|-0.124||||0.754|TWO_SIDED|95.0|-0.903|0.654|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.654|-0.903|0.754
70864911|NCT00546104|141215714|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.1||0.3|TWO_SIDED|95.0|-0.3|0.1|||t-test, 1 sided|||||.10|-.30|0.3
70948239|NCT05878873|141397529|OTHER||Mean Difference (Net)|-0.078|STANDARD_ERROR_OF_MEAN|0.027||0.007|TWO_SIDED|||||This value was adjusted using false discovery rate.|Mixed Models Analysis|Degrees of freedom = 44.|This estimate calculation is TENS ON - TENS OFF.|Statistical analysis comparing cortical activation between TENS ON and TENS OFF conditions in people with multiple sclerosis.||||0.007
70948240|NCT05878873|141397529|OTHER||Mean Difference (Net)|-0.089|STANDARD_ERROR_OF_MEAN|0.032||0.008|TWO_SIDED|||||This value was adjusted using false discovery rate.|Mixed Models Analysis|Degrees of freedom = 44|The estimate calculation is TENS ON - TENS OFF.|Statistical analysis comparing cortical activation between TENS ON and TENS OFF conditions in healthy controls.||||0.008
70948241|NCT05878873|141397530|OTHER||Mean Difference (Net)|0.042|STANDARD_ERROR_OF_MEAN|0.0141||0.014|TWO_SIDED|||||This value was adjusted using false discovery rate.|Mixed Models Analysis|Degrees of freedom = 44|This estimate calculation is TENS ON - TENS OFF at Visit 2.|Statistical analysis comparing savings between TENS ON and TENS OFF conditions in people with multiple sclerosis.||||0.014
70948242|NCT05878873|141397530|OTHER||Mean Difference (Net)|-0.0058|STANDARD_ERROR_OF_MEAN|0.167||0.878|TWO_SIDED|||||This value was corrected with false discovery rate.|Mixed Models Analysis|Degrees of freedom = 44|The estimate calculation is TENS ON - TENS OFF at Visit 2|Statistical analysis comparing savings between TENS ON and TENS OFF conditions in healthy controls.||||0.878
70948243|NCT05878873|141397531|OTHER||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.018||0.898|TWO_SIDED|||||This value was corrected using false discovery rate.|Mixed Models Analysis|Degrees of freedom = 44|The estimate calculation is TENS ON - TENS OFF|Statistical analysis comparing rate of adaptation between TENS ON and TENS OFF conditions in people with multiple sclerosis.||||0.898
70948244|NCT05878873|141397531|OTHER||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.021||0.698|TWO_SIDED|||||This value was corrected using false discovery rate.|Mixed Models Analysis|Degrees of freedom = 44|The estimate calculation is TENS ON - TENS OFF|Statistical analysis comparing rate of adaptation between TENS ON and TENS OFF conditions in healthy controls.||||0.698
70948245|NCT03865953|141397546|SUPERIORITY|Analysis used a two-period two-treatment crossover design|Mean Difference (Net)|-0.14||||0.67|TWO_SIDED|95.0|-0.76|0.49|||Mixed Models Analysis|||Subject numbers gave a 90% power to demonstrate a statistically significant difference in the mean change from baseline NPRS for the active treatment compared with placebo of at least 1 unit, with a two sided test at a 5% level of significance||0.49|-0.76|0.67
70948246|NCT00882115|141397561|OTHER||||||<|0.001|||||||ANOVA|Data followed the normal distribution, therefore, a parametric repeated measure (mixed model) ANOVA model was used to compare means.||Comparison was made to the 24 h minus baseline change in both control phase and intervention phase.||||<0.001
70948247|NCT00882115|141397561|OTHER||||||<|0.01|||||||ANOVA|Data followed the normal distribution, therefore, a parametric repeated measure (mixed model) ANOVA model was used to compare means.||Comparison waws made to the 6 hour minus baseline change in both control phase and intervention phase.||||<0.01
70948248|NCT01271504|141397580|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.56|1.5||||||||1.50|0.56|
70948249|NCT01271504|141397581|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.57|1.5||||||||1.50|0.57|
70948250|NCT01271504|141397583|SUPERIORITY||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.6|1.62||||||||1.62|0.60|
70948251|NCT02552147|141397585|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|Two-tailed||||||.44
70948252|NCT02552147|141397586|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|Two-tailed||||||0.38
71139505|NCT03084796|141778131|SUPERIORITY||Mean Difference (Final Values)|0.278||||0.485|TWO_SIDED|95.0|-0.503|1.06|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.060|-0.503|0.485
71139506|NCT03084796|141778131|SUPERIORITY||Mean Difference (Final Values)|-1.349||||0.005|TWO_SIDED|95.0|-2.294|-0.403|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.403|-2.294|0.005
71139507|NCT03084796|141778131|SUPERIORITY||Mean Difference (Final Values)|-1.159||||0.016|TWO_SIDED|95.0|-2.1|-0.218|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.218|-2.100|0.016
70948253|NCT02552147|141397590|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|Two-tailed||||||0.13
70948254|NCT02552147|141397591|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|Two-tailed||||||0.13
70948255|NCT02552147|141397592|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|Two-tailed||||||0.50
70948256|NCT02552147|141397593|SUPERIORITY|||||||1||||||P value was calculated to \>0.99 and thus rounded to 1.0.|Wilcoxon (Mann-Whitney)|Two-tailed||||||1.0
70948257|NCT02552147|141397594|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|Two-tailed||||||0.25
70948258|NCT02552147|141397595|SUPERIORITY|||||||0.69|||||||Binomial test|||||||0.69
70948259|NCT03434028|141397612|SUPERIORITY||difference in mortality rate|-0.9||||0.61|TWO_SIDED|95.0|-4.4|2.6|||Z-test|||||2.6|-4.4|0.61
70948260|NCT03434028|141397613|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.5|1.2|||||The mean values is an estimate from the Kaplan-Meier curve, thus it is correct as reported.|||1.2|-0.5|
70948261|NCT03434028|141397614|SUPERIORITY||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.4|1.6||||||||1.6|-0.4|
70948262|NCT03434028|141397615|SUPERIORITY||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.8|1.2||||||||1.2|-0.8|
70948263|NCT03434028|141397616|SUPERIORITY||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.5|1.3||||||||1.3|-0.5|
70948264|NCT03434028|141397617|SUPERIORITY||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.8|1.0||||||||1.0|-0.8|
70948265|NCT03434028|141397618|SUPERIORITY||Mean Difference (Final Values)|0.8|||||TWO_SIDED|95.0|-0.3|1.9||||||||1.9|-0.3|
70948266|NCT03434028|141397619|SUPERIORITY||Risk Difference (RD)|-1.7|||||TWO_SIDED|95.0|-5.1|1.7||||||||1.7|-5.1|
70948267|NCT03434028|141397620|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-1.8|1.8||||||||1.8|-1.8|
70948268|NCT03434028|141397621|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||||0.1|-0.1|
70948269|NCT03434028|141397622|SUPERIORITY||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.3|0.4||||||||0.4|-0.3|
70948270|NCT03434028|141397623|SUPERIORITY||Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-1.7|1.5||||||||1.5|-1.7|
70948271|NCT03434028|141397624|SUPERIORITY||Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-3.7|1.7||||||||1.7|-3.7|
70948272|NCT03434028|141397625|SUPERIORITY||Risk Difference (RD)|0.5|||||TWO_SIDED|95.0|-3.6|4.7||||||||4.7|-3.6|
70948273|NCT02037776|141397626|SUPERIORITY|||||||0.038|||||||Wilcoxon (Mann-Whitney)|||Comparison between groups in Rikkunshito Placebo and Rikkunshito, based on the count of participants categorized in 1 (Significantly improved) through 7 (Much worse), using the Wilcoxon (Mann-Whitney).||||0.038
70948274|NCT02037776|141397627|SUPERIORITY|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in all symptoms of modified FSSG||||0.027
70948275|NCT02037776|141397627|SUPERIORITY|||||||0.089|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in GERD symptoms of modified FSSG||||0.089
71139508|NCT03084796|141778131|SUPERIORITY||Mean Difference (Final Values)|-1.466||||0.003|TWO_SIDED|95.0|-2.416|-0.516|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.516|-2.416|0.003
71139509|NCT03084796|141778131|SUPERIORITY||Mean Difference (Final Values)|-1.396||||0.004|TWO_SIDED|95.0|-2.337|-0.454|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.454|-2.337|0.004
71139510|NCT03084796|141778131|SUPERIORITY||Mean Difference (Final Values)|-0.824||||0.097|TWO_SIDED|95.0|-1.797|0.15|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.150|-1.797|0.097
71139511|NCT03084796|141778131|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.69|TWO_SIDED|95.0|-0.746|1.126|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.126|-0.746|0.690
71139512|NCT03084796|141778131|SUPERIORITY||Mean Difference (Final Values)|-0.117||||0.808|TWO_SIDED|95.0|-1.061|0.827|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.827|-1.061|0.808
71139513|NCT03084796|141778131|SUPERIORITY||Mean Difference (Final Values)|-0.047||||0.922|TWO_SIDED|95.0|-0.983|0.889|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.889|-0.983|0.922
71139514|NCT03084796|141778131|SUPERIORITY||Mean Difference (Final Values)|-0.307||||0.522|TWO_SIDED|95.0|-1.248|0.634|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.634|-1.248|0.522
71139515|NCT03084796|141778131|SUPERIORITY||Mean Difference (Final Values)|-0.237||||0.618|TWO_SIDED|95.0|-1.17|0.696|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.696|-1.170|0.618
71139516|NCT03084796|141778131|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.884|TWO_SIDED|95.0|-0.871|1.012|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.012|-0.871|0.884
71139517|NCT03084796|141778131|SUPERIORITY||Mean Difference (Final Values)|-1.158||||0.006|TWO_SIDED|95.0|-1.978|-0.337|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.337|-1.978|0.006
71139518|NCT03084796|141778131|SUPERIORITY||Mean Difference (Final Values)|-0.992||||0.017|TWO_SIDED|95.0|-1.808|-0.175|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.175|-1.808|0.017
71139519|NCT03084796|141778131|SUPERIORITY||Mean Difference (Final Values)|-1.346||||0.001|TWO_SIDED|95.0|-2.168|-0.524|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.524|-2.168|0.001
71139520|NCT03084796|141778131|SUPERIORITY||Mean Difference (Final Values)|-1.172||||0.005|TWO_SIDED|95.0|-1.991|-0.353|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.353|-1.991|0.005
71139521|NCT03084796|141778131|SUPERIORITY||Mean Difference (Final Values)|-0.695||||0.107|TWO_SIDED|95.0|-1.539|0.149|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.149|-1.539|0.107
71139522|NCT03084796|141778131|SUPERIORITY||Mean Difference (Final Values)|0.166||||0.689|TWO_SIDED|95.0|-0.648|0.98|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.980|-0.648|0.689
71139523|NCT03084796|141778131|SUPERIORITY||Mean Difference (Final Values)|-0.188||||0.651|TWO_SIDED|95.0|-1.007|0.63|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.630|-1.007|0.651
70948276|NCT02037776|141397627|SUPERIORITY|||||||0.148|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in dyspeptic symptoms of modified FSSG||||0.148
70948277|NCT02037776|141397628|SUPERIORITY|||||||0.051|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in total score of PAGI-SYM||||0.051
70948278|NCT02037776|141397628|SUPERIORITY|||||||0.947|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Heartburn/Regurgitation of PAGI-SYM||||0.947
70948279|NCT02037776|141397628|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Nausea/Vomiting of PAGI-SYM||||0.157
70948280|NCT02037776|141397628|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Postprandial Fullness/Early satiety of PAGI-SYM||||0.004
70948281|NCT02037776|141397628|SUPERIORITY|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Bloating of PAGI-SYM||||0.011
70948282|NCT02037776|141397628|SUPERIORITY|||||||0.245|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Upper Abdominal Pain of PAGI-SYM||||0.245
70948283|NCT02037776|141397628|SUPERIORITY|||||||0.387|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Lower Abdominal Pain of PAGI-SYM||||0.387
70948284|NCT02037776|141397629|SUPERIORITY|||||||0.034|||||||Wilcoxon (Mann-Whitney)|||||||0.034
70948285|NCT02037776|141397630|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in PCS of SF-8||||0.270
71139524|NCT03084796|141778131|SUPERIORITY||Mean Difference (Final Values)|-0.014||||0.973|TWO_SIDED|95.0|-0.83|0.801|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.801|-0.830|0.973
71139525|NCT03084796|141778131|SUPERIORITY||Mean Difference (Final Values)|-0.355||||0.393|TWO_SIDED|95.0|-1.17|0.461|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.461|-1.170|0.393
70948286|NCT02037776|141397630|SUPERIORITY|||||||0.342|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in MCS of SF-8||||0.342
70948287|NCT02037776|141397631|SUPERIORITY|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in overall point score of HAD||||0.036
70948288|NCT02037776|141397631|SUPERIORITY|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in depression point score of HAD||||0.084
70948289|NCT02037776|141397631|SUPERIORITY|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in anxiety point score of HAD||||0.022
70948290|NCT04147858|141397633|SUPERIORITY|||||||0.539|||||||t-test, 2 sided|||||||0.539
70948291|NCT04147858|141397633|SUPERIORITY|||||||0.425|||||||t-test, 2 sided|||||||0.425
70948292|NCT04147858|141397634|SUPERIORITY|||||||0.824|||||||t-test, 2 sided|||||||0.824
70948293|NCT04147858|141397634|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
70948294|NCT04147858|141397635|SUPERIORITY|||||||0.297|||||||t-test, 2 sided|||||||0.297
70948295|NCT04147858|141397635|SUPERIORITY|||||||0.603|||||||t-test, 2 sided|||||||0.603
70948296|NCT04147858|141397636|SUPERIORITY|||||||0.871|||||||t-test, 2 sided|||||||0.871
70948297|NCT04147858|141397636|SUPERIORITY|||||||0.352|||||||t-test, 2 sided|||||||0.352
70948298|NCT04147858|141397637|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
70948299|NCT04147858|141397637|SUPERIORITY|||||||0.626|||||||t-test, 2 sided|||||||0.626
70948300|NCT04147858|141397638|SUPERIORITY|||||||0.059|||||||t-test, 2 sided|||||||0.059
70948301|NCT04147858|141397638|SUPERIORITY|||||||0.726|||||||t-test, 2 sided|||||||0.726
70948302|NCT04147858|141397639|SUPERIORITY|||||||0.888|||||||t-test, 2 sided|||||||0.888
70948303|NCT04147858|141397639|SUPERIORITY|||||||0.832|||||||t-test, 2 sided|||||||0.832
70948304|NCT04147858|141397640|SUPERIORITY|||||||0.536|||||||t-test, 2 sided|||||||0.536
70948305|NCT04147858|141397640|SUPERIORITY|||||||0.982|||||||t-test, 2 sided|||||||0.982
70948306|NCT04147858|141397641|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||||||0.190
70948307|NCT04147858|141397641|SUPERIORITY|||||||0.764|||||||t-test, 2 sided|||||||0.764
70948308|NCT04147858|141397642|SUPERIORITY|||||||0.097|||||||t-test, 2 sided|||||||0.097
70948309|NCT04147858|141397642|SUPERIORITY|||||||0.849|||||||t-test, 2 sided|||||||0.849
70948310|NCT03786744|141397647|SUPERIORITY||Mean Difference (Net)|9.0||||0.049367|TWO_SIDED|||||Alternative hypothesis: can be changed of speech, language, communication skills for Cord Blood versus Placebo groups in 2-month Threshold \<0.05|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile||||0.049367
70948311|NCT03786744|141397647|SUPERIORITY||Median Difference (Net)|9.0||||0.004072|TWO_SIDED|||||"Alternative hypothesis: can be changed average of 2-month of Health/Physical Development/Behaviour for Cord Blood versus Control groups.~Threshold \<0.05"|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0 and MS Office Excel 2007. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile.||||0.004072
71139526|NCT03084796|141778131|SUPERIORITY||Mean Difference (Final Values)|-0.181||||0.663|TWO_SIDED|95.0|-0.993|0.632|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.632|-0.993|0.663
71139527|NCT03084796|141778131|SUPERIORITY||Mean Difference (Final Values)|0.174||||0.676|TWO_SIDED|95.0|-0.643|0.991|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.991|-0.643|0.676
70948312|NCT03786744|141397647|SUPERIORITY||Mean Difference (Net)|9.0||||0.017258|TWO_SIDED|||||"Alternative hypothesis: can be changed average of 12-month of Health/Physical Development/Behaviour for Cord Blood versus Placebo groups.~Threshold \<0.05"|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0 and MS Office Excel 2007. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile.||||0.017258
70948313|NCT03786744|141397647|SUPERIORITY||Mean Difference (Net)|10.0||||0.03121|TWO_SIDED|||||"Alternative hypothesis: can be changed average of 1-month of total score for Cord Blood versus Placebo groups.~Threshold \<0.05"|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile||||0.031210
70948314|NCT03786744|141397647|SUPERIORITY||Mean Difference (Net)|24.0||||0.00194|TWO_SIDED|||||"Alternative hypothesis: can be changed average of 2-month of Total score for Cord Blood versus Placebo groups.~Threshold \<0.05"|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile||||0.001940
70948315|NCT03786744|141397647|SUPERIORITY||Mean Difference (Net)|15.0||||0.03121|TWO_SIDED|||||"Alternative hypothesis: can be changed average of 6-month of Total score for Cord Blood versus Placebo groups.~Threshold \<0.05"|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile||||0.031210
70948316|NCT03786744|141397647|SUPERIORITY||Mean Difference (Net)|16.0||||0.01133|TWO_SIDED|||||"Alternative hypothesis: can be changed average of 12-month of Total score for Cord Blood versus Placebo groups.~Threshold \<0.05"|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile||||0.011330
70948317|NCT04683510|141397660|SUPERIORITY||Odds Ratio (OR)|1.647||||0.2345|TWO_SIDED|95.0|0.724|3.746|||Regression, Logistic|||||3.746|0.724|0.2345
70948318|NCT04683510|141397660|SUPERIORITY||Odds Ratio (OR)|1.897||||0.124|TWO_SIDED|95.0|0.839|4.291|||Regression, Logistic|||||4.291|0.839|0.124
71139528|NCT02741245|141778167|OTHER||Difference in M-estimates|-35.9|||<|0.001|TWO_SIDED|95.0|-39.9|-32.0|||Shapiro-Wilk test|Robust regression model with terms for treatment, risk category and baseline, after imputing missing values by a multiple imputation approach||||-32.0|-39.9|<0.001
71139529|NCT02741245|141778167|OTHER|Robust regression model with terms for treatment, risk category and baseline, after imputing missing values by a multiple imputation approach|Difference in M-estimates|-14.8|||<|0.001|TWO_SIDED|95.0|-18.0|-11.6|||Shapiro-Wilk test|||||-11.6|-18.0|<0.001
71139530|NCT02741245|141778167|OTHER|Robust regression model with terms for treatment, risk category and baseline, after imputing missing values by a multiple imputation approach|Difference in M-estimates|-41.8|||<|0.001|TWO_SIDED|95.0|-45.8|-37.9|||Shapiro-Wilk test|||||-37.9|-45.8|<0.001
71139531|NCT02741245|141778167|OTHER|Robust regression model with terms for treatment, risk category and baseline, after imputing missing values by a multiple imputation approach|Differecne in M-estimates|-13.3|||<|0.001|TWO_SIDED|95.0|-16.6|-10.1|||Shapiro-Wilk test|||||-10.1|-16.6|<0.001
71139532|NCT01300234|141778206|SUPERIORITY_OR_OTHER||percentage of participants|58.5|||<|0.0001|TWO_SIDED|97.5|45.8|71.3||HBeAg-positive participants|Roche COBAS Taqman HBV test||"A non-completers equal failures approach is used for the primary analysis. The estimated value represents the difference between the percentage of participants achieving HBV DNA \<400 copies/mL at Week 48 in the TDF group and the ADV group."|||71.3|45.8|<0.0001
71139533|NCT01300234|141778206|SUPERIORITY_OR_OTHER||percentage of participants|25.6|||<|0.0001|TWO_SIDED|97.5|16.7|34.3||HBeAg-negative participants|Roche COBAS Taqman HBV test||"A non-completers equal failures approach was used for the primary analysis. The estimated value represents the difference between the percentage of participants achieving HBV DNA \<400 copies/mL at Week 48 in the TDF group and the ADV group."|||34.3|16.7|<0.0001
71139534|NCT00550407|141778261|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Log Rank|||||||0.010
70948319|NCT04683510|141397661|SUPERIORITY||Odds Ratio (OR)|0.905||||0.2352|TWO_SIDED|95.0|0.768|1.067|||Regression, Logistic|||||1.067|0.768|0.2352
70948320|NCT04683510|141397661|SUPERIORITY||Odds Ratio (OR)|0.924||||0.3418|TWO_SIDED|95.0|0.785|1.088|||Regression, Logistic|||||1.088|0.785|0.3418
70948321|NCT04683510|141397662|SUPERIORITY||Odds Ratio (OR)|1.22||||0.1653|TWO_SIDED|95.0|0.921|1.615|||Regression, Logistic|||||1.615|0.921|0.1653
70948322|NCT04683510|141397662|SUPERIORITY||Odds Ratio (OR)|1.213||||0.181|TWO_SIDED|95.0|0.914|1.609|||Regression, Logistic|||||1.609|0.914|0.181
71139535|NCT00871871|141778293|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.1||||0.067|TWO_SIDED|90.0|-0.22|0.01||one-sided, alpha = 0.05|ANCOVA|||||0.01|-0.22|0.067
71139536|NCT00871871|141778294|SUPERIORITY_OR_OTHER||Least squares mean difference|1.1|||>|0.5|TWO_SIDED|90.0|0.86|1.34|||ANCOVA|||||1.34|0.86|>0.500
71139537|NCT00871871|141778295|SUPERIORITY_OR_OTHER||Least squares mean difference|0.016||||0.13|TWO_SIDED|90.0|-0.012|0.044||one-sided, alpha = 0.05|ANOVA|||||0.044|-0.012|0.130
71139538|NCT00871871|141778296|SUPERIORITY_OR_OTHER||Least squares mean difference|0.54|||>|0.5|TWO_SIDED|90.0|0.4|0.67|||ANCOVA|||||0.67|0.40|>0.500
70948323|NCT03522389|141397663|SUPERIORITY|||||||0.003|||||||ANOVA|||After 4 weeks of training - Baseline (T2-T1)||||0.003
70948324|NCT03522389|141397663|SUPERIORITY||||||<|0.001|||||||ANOVA|||1-month follow up - Baseline (T3-T1)||||<0.001
70948325|NCT03522389|141397663|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
71139539|NCT00871871|141778297|SUPERIORITY_OR_OTHER||Least squares mean difference|0.004||||0.342|TWO_SIDED|90.0|-0.023|0.014||one-sided, alpha = 0.05|ANOVA|||||0.014|-0.023|0.342
71139540|NCT00871871|141778298|SUPERIORITY_OR_OTHER||Least squares mean difference|0.0016|||>|0.5|TWO_SIDED|90.0|-0.008|0.011|||ANOVA|||||0.011|-0.008|>0.500
71139541|NCT00871871|141778299|SUPERIORITY_OR_OTHER||Least squares mean difference|0.003|||>|0.5|TWO_SIDED|90.0|-0.003|0.01|||ANOVA|||||0.010|-0.003|>0.500
71139542|NCT01928927|141778322|SUPERIORITY||Theta statistic|0.5||||0.97|TWO_SIDED|95.0|0.26|0.73||No adjustment for multiple comparisons|Theta statistic; DeLong & Clarke-Pearson||The theta statistic estimates the probability that a randomly selected outcome from the telmisartan arm is \<= a randomly selected outcome from the control arm.|Null hypothesis: theta = 0.50||0.73|0.26|0.97
71139543|NCT01928927|141778323|SUPERIORITY||Theta statistic|0.57||||0.61|TWO_SIDED|95.0|0.31|0.83||No adjustment for multiple comparisons|Theta statistic; DeLong & Clarke-Pearson||The theta statistic estimates the probability that a randomly selected outcome from the telmisartan arm is \<= a randomly selected outcome from the control arm.|Null hypothesis: theta = 0.50||0.83|0.31|0.61
71139544|NCT02421172|141778425|SUPERIORITY_OR_OTHER_LEGACY||Posterior probablility|0.9729||||||||||||||||||
71139545|NCT00683878|141778435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1175||0.0007|TWO_SIDED|95.0|-0.63|-0.17||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment|ANCOVA|||||-0.17|-0.63|0.0007
71139546|NCT00683878|141778435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.1175|<|0.0001|TWO_SIDED|95.0|-0.78|-0.31||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment|ANCOVA|||||-0.31|-0.78|<0.0001
71139547|NCT00683878|141778436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.0|STANDARD_ERROR_OF_MEAN|9.007|<|0.0001|TWO_SIDED|95.0|-68.7|-33.2||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-33.2|-68.7|<0.0001
71139548|NCT00683878|141778436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-53.3|STANDARD_ERROR_OF_MEAN|9.039|<|0.0001|TWO_SIDED|95.0|-71.1|-35.6||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-35.6|-71.1|<0.0001
71139549|NCT00683878|141778437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55|STANDARD_ERROR_OF_MEAN|0.3896|<|0.0001|TWO_SIDED|95.0|-2.32|-0.79||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-0.79|-2.32|<0.0001
71139550|NCT00683878|141778437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.78|STANDARD_ERROR_OF_MEAN|0.3896|<|0.0001|TWO_SIDED|95.0|-2.55|-1.02||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-1.02|-2.55|<0.0001
71139551|NCT00683878|141778438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5|STANDARD_ERROR_OF_MEAN|4.088|<|0.0001|TWO_SIDED|95.0|-27.5|-11.4||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-11.4|-27.5|<0.0001
71139552|NCT00683878|141778438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.1|STANDARD_ERROR_OF_MEAN|4.082|<|0.0001|TWO_SIDED|95.0|-32.2|-16.1||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-16.1|-32.2|<0.0001
71139553|NCT00683878|141778439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.1|STANDARD_ERROR_OF_MEAN|5.119||0.0496|TWO_SIDED|95.0|0.0|20.1||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|Modified logistic regression|||||20.1|0.0|0.0496
71139554|NCT00683878|141778439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.4|STANDARD_ERROR_OF_MEAN|5.253||0.0018|TWO_SIDED|95.0|6.1|26.7||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|Modified logistic regression|||||26.7|6.1|0.0018
71139555|NCT00683878|141778440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.6006||0.1566|TWO_SIDED|95.0|-2.03|0.33||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||0.33|-2.03|0.1566
71139556|NCT00683878|141778440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55|STANDARD_ERROR_OF_MEAN|0.5995||0.0101|TWO_SIDED|95.0|-2.73|-0.37||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-0.37|-2.73|0.0101
71139557|NCT00683878|141778441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|0.4838|||TWO_SIDED|95.0|-2.53|-0.62||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. The comparison was stopped due to the preceding test (PLACEBO + Pio vs Dapa 5MG + Pio) not statistically significant P value = 0.1566.|ANCOVA|||||-0.62|-2.53|
71139558|NCT00683878|141778441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.4688|<|0.0001|TWO_SIDED|95.0|-2.83|-0.98||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-0.98|-2.83|<0.0001
71139559|NCT03112681|141778442|SUPERIORITY|||||||0.0001|||||||paired t-test|||||||0.0001
70948326|NCT03522389|141397663|SUPERIORITY|||||||0.006|||||||ANOVA|||Within group comparison||||0.006
70948327|NCT03522389|141397663|SUPERIORITY|||||||0.793|||||||ANOVA|||Within group comparison||||0.793
70948328|NCT03522389|141397664|SUPERIORITY||||||<|0.001|||||||ANOVA|||After 4 weeks of training - Baseline (T2-T1)||||<0.001
70948329|NCT03522389|141397664|SUPERIORITY|||||||0.039|||||||ANOVA|||1-month follow-up - Baseline (T3-T1)||||0.039
70948330|NCT03522389|141397664|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
70948331|NCT03522389|141397664|SUPERIORITY|||||||0.002|||||||ANOVA|||Within group comparison||||0.002
70948332|NCT03522389|141397664|SUPERIORITY|||||||0.117|||||||ANOVA|||Within group comparison||||0.117
70948333|NCT03522389|141397665|SUPERIORITY|||||||0.924|||||||ANOVA|||After 4 weeks of training - Baseline (T2-T1)||||0.924
70948334|NCT03522389|141397665|SUPERIORITY|||||||0.855|||||||ANOVA|||1-month follow-up - Baseline (T3-T1)||||0.855
70948335|NCT03522389|141397665|SUPERIORITY|||||||0.937|||||||ANOVA|||Within group comparison||||0.937
70948336|NCT03522389|141397665|SUPERIORITY|||||||0.97|||||||ANOVA|||Within group comparison||||0.970
70948337|NCT03522389|141397665|SUPERIORITY|||||||0.242|||||||ANOVA|||Within group comparison||||0.242
70948338|NCT03522389|141397666|SUPERIORITY|||||||0.161|||||||ANOVA|||After 4 weeks of training - Baseline (T2-T1)||||0.161
70948339|NCT03522389|141397666|SUPERIORITY|||||||0.161|||||||ANOVA|||1-month follow-up - Baseline (T3-T1)||||0.161
70948340|NCT03522389|141397666|SUPERIORITY|||||||0.076|||||||ANOVA|||Within group comparison||||0.076
70948341|NCT03522389|141397666|SUPERIORITY|||||||0.211|||||||ANOVA|||Within group comparison||||0.211
70948342|NCT03522389|141397666|SUPERIORITY|||||||0.573|||||||ANOVA|||Within group comparison||||0.573
71139560|NCT03112681|141778442|SUPERIORITY|||||||0.0002|||||||paired t-test|||||||0.0002
71139561|NCT04024891|141778448|SUPERIORITY||Mean Difference (Net)|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.7|||Mixed Models Analysis|||||-0.7|-1.3|<0.0001
71139562|NCT03489863|141778457|NON_INFERIORITY|see above|Mean Difference (Net)|-18.0|||<|0.05|TWO_SIDED|95.0|-38.0|2.0|||ANCOVA|||The primary endpoint is non-inferiority in PRU, at 24 hours of prasugrel versus ticagrelor. Under the assumption of 0 difference at 24 hours in mean PRU between ticagrelor and prasugrel and a common standard deviation of 50 PRU, a sample size of 22 patients per group allows for the 95% CI to stay within ± 45 PRU with a 90% power and alpha = 0.05.||2|-38|<0.05
71139563|NCT01173016|141778478|OTHER|||||||0.038|||||||Regression, Logistic|||Impact of anti-laronidase antibody status on the change in 6MWT outcome was tested||||0.038
71139564|NCT00657540|141778479|SUPERIORITY_OR_OTHER|||||||0.0185|||||||Chi-squared|The proportion of treatment failures was compared between groups using a one-sided test at the 0.025 level of significance.||||||0.0185
71139565|NCT00657540|141778480|SUPERIORITY_OR_OTHER|||||||0.2302|||||||Chi-squared|Chi-squared tests at the 0.025 level of significance were used to test for a difference in proportions between the treatment groups.||||||0.2302
71139566|NCT00657540|141778481|SUPERIORITY_OR_OTHER|||||||0.8213|||||||Chi-squared|The proportion of subjects with at least one drug-related adverse event by treatment groups using a two-sided test at the 0.05 level of significance.||||||0.8213
71139567|NCT00657540|141778482|SUPERIORITY_OR_OTHER|||||||0.2765|||||||Chi-squared|The proportion of subjects with decreased pain at any time point between treatment groups using a one-sided test at the 0.025 level of significance.||||||0.2765
71139568|NCT02656017|141778489|SUPERIORITY||Mean Difference (Net)|0.07||||0.5|TWO_SIDED|95.0|-0.13|0.26|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in GSRS score as a function of time, the interaction between time and study arm, and clinical site.||0.26|-0.13|0.50
71139569|NCT02656017|141778490|SUPERIORITY|||||||0.12|||||||Gray's test|||The Gray's test of homogeneity for competing risks was used to compare cumulative incidence of tolerating the drug between study arms.||||0.12
71139570|NCT02656017|141778491|SUPERIORITY|||||||0.98|||||||Regression, Logistic|||Cumulative incidence between study arms and logistic regression was used to assess the association between study arms.||||0.98
71139571|NCT02656017|141778492|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.72|TWO_SIDED|95.0|-1.81|2.6|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in SF-36 PCS as a function of time, the interaction between time and study arm, and clinical site.||2.60|-1.81|0.72
71139572|NCT02656017|141778493|SUPERIORITY||Mean Difference (Final Values)|1.11||||0.49|TWO_SIDED|95.0|-2.02|4.25|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in SF-36 MCS as a function of time, the interaction between time and study arm, and clinical site.||4.25|-2.02|0.49
71139573|NCT02656017|141778494|SUPERIORITY|||||||0.44|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept and slope was used to compare back pain frequency as a function of time, the interaction between time and study arm, and clinical site.||||0.44
70948343|NCT03522389|141397667|SUPERIORITY|||||||0.445|||||||ANOVA|||After 4 weeks of training - Baseline (T2-T1)||||0.445
70948344|NCT03522389|141397667|SUPERIORITY|||||||0.046|||||||ANOVA|||1-month follow-up - Baseline (T3-T1)||||0.046
70948345|NCT03522389|141397667|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
70948346|NCT03522389|141397667|SUPERIORITY|||||||0.028|||||||ANOVA|||Within group comparison||||0.028
70948347|NCT03522389|141397667|SUPERIORITY|||||||0.002|||||||ANOVA|||Within group comparison||||0.002
70948348|NCT03494985|141397713|OTHER||Least square mean difference|0.6|||<|0.0001|TWO_SIDED|95.0|0.4|0.9||p-value was adjusted using Dunnett's method for multiple comparisons|ANOVA|ANOVA model with factors for treatment, study site and DMI stratification (mild, moderate, severe).|First named treatment minus second named treatment such that a positive value favours the first named treatment.|||0.9|0.4|<0.0001
70948349|NCT03494985|141397713|OTHER||LS mean difference|0.9|||<|0.0001|TWO_SIDED|95.0|0.6|1.2||p-value was adjusted using Dunnett's method for multiple comparisons|ANOVA|ANOVA model with factors for treatment, study site and DMI stratification (mild, moderate, severe).|First named treatment minus second named treatment such that a positive value favours the first named treatment.|||1.2|0.6|<0.0001
70948350|NCT03494985|141397713|OTHER||LS mean difference|0.6|||<|0.0001|TWO_SIDED|95.0|0.3|0.9||p-value was adjusted using Dunnett's method for multiple comparisons.|ANOVA|ANOVA model with factors for treatment, study site and DMI stratification (mild, moderate, severe).|First named treatment minus second named treatment such that a positive value favours the first named treatment.|||0.9|0.3|<0.0001
71139574|NCT02656017|141778495|SUPERIORITY||Mean Difference (Final Values)|2.73||||0.2|TWO_SIDED|95.0|-1.4|6.87|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in eGFR as a function of time, the interaction between time and study arm, and clinical site.||6.87|-1.40|0.20
71139575|NCT02656017|141778496|SUPERIORITY||Mean Difference (Final Values)|1.68||||0.38|TWO_SIDED|95.0|-2.11|5.62|||Mixed Models Analysis|||Linear mixed model with random intercept and slope was used to compare the annual percent change of ln(htTKV) as a function of time, the interaction between time and study arm, and clinical site.||5.62|-2.11|0.38
71139576|NCT02656017|141778497|SUPERIORITY||Mean Difference (Final Values)|3.81||||0.31|TWO_SIDED|95.0|-3.48|11.65|||Mixed Models Analysis|||Linear mixed model with random intercept and slope was used to compare the annual percent change of ln(htTKCV) as a function of time, the interaction between time and study arm, and clinical site.||11.65|-3.48|0.31
71139577|NCT02656017|141778498|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.72|TWO_SIDED|95.0|-1.78|2.61|||Mixed Models Analysis|||Linear mixed model with random intercept and slope was used to compare the annual percent change of ln(htLV) as a function of time, the interaction between time and study arm, and clinical site.||2.61|-1.78|0.72
70948351|NCT05093504|141397728|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
70948352|NCT02272244|141397738|SUPERIORITY||Odds Ratio (OR)|4.83|||<|0.001|TWO_SIDED|95.0|3.08|7.58|||Regression, Logistic|Model adjusted for age, sex, practice, baseline preferred test and baseline overall decision stage||||7.58|3.08|<0.001
70948353|NCT02272244|141397739|SUPERIORITY||Odds Ratio (OR)|4.91|||<|0.001|TWO_SIDED|95.0|2.55|9.47|||Regression, Logistic|Model compares Forward Change to No Change or Backwards Change and is adjusted for all baseline covariates.||||9.47|2.55|<0.001
70948354|NCT02272244|141397740|SUPERIORITY||||||<|0.001|||||||Regression, Multinomial|Model compared rates of SBT, CX and none; model is adjusted for age, sex, practice, baseline preferred test and baseline overall decision stage|||Reference for the outcome is No Screening; reference for the study group is the Standard Intervention group.|||<0.001
70948355|NCT02272244|141397740|SUPERIORITY||Odds Ratio (OR)|4.2||||0.001|TWO_SIDED|95.0|2.63|6.7|||Odds Ratio (OR)|Stool Blood Test vs None||||6.70|2.63|0.001
70948356|NCT02272244|141397740|SUPERIORITY|Colonscopy vs None|Odds Ratio (OR)|8.79||||0.001|TWO_SIDED|95.0|4.13|18.74|||Odds Ratio (OR)|||||18.74|4.13|0.001
70948357|NCT02272244|141397741|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.862|TWO_SIDED|95.0|-0.15|0.13|||Regression, Linear|Model of difference in Preventive Health Model (PHM) total score adjusts for all baseline covariates.|Model compares DSNI to SI.|||0.13|-0.15|0.862
71139578|NCT02656017|141778499|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.8|TWO_SIDED|95.0|-10.05|14.76|||Mixed Models Analysis|||Linear mixed model with random intercept and slope was used to compare the annual percent change of ln(htLCV) as a function of time, the interaction between time and study arm, and clinical site.||14.76|-10.05|0.80
71139579|NCT02656017|141778500|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept and slope was used to compare abdominal fullness interfered as a function of time, the interaction between time and study arm, and clinical site.||||0.83
71139580|NCT02656017|141778501|SUPERIORITY|||||||0.72|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept and slope was used to compare interference of pain with sleep frequency as a function of time, the interaction between time and study arm, and clinical site.||||0.72
71139581|NCT02656017|141778502|SUPERIORITY|||||||0.28|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept and slope was used to compare interference of pain with strenuous physical activity frequency as a function of time, the interaction between time and study arm, and clinical site.||||0.28
71139582|NCT04245111|141778503|OTHER|No other statistical analysis completed other than percentage of patients completed as reported in the data table section||||||||||||||||No other statistical analysis completed other than percentage of patients completed as reported in the data table section|No other statistical analysis completed other than percentage of patients completed as reported in the data table section|||
71139583|NCT03192176|141778513|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.84||0.024|TWO_SIDED|95.0|-3.56|-0.25||LS Means(LSM), standard errors(SE), confidence intervals(CI), \& p-values come from an ANCOVA model with CFB as the dependent variable \& treatment group, pooled center, smoking status as factors \& baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.25|-3.56|0.0240
71139584|NCT03192176|141778513|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.84||0.0004|TWO_SIDED|95.0|-4.68|-1.38||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-1.38|-4.68|0.0004
71139585|NCT03192176|141778513|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.84||0.001|TWO_SIDED|95.0|-4.44|-1.14||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-1.14|-4.44|0.0010
71139586|NCT03192176|141778513|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|0.84|<|0.0001|TWO_SIDED|95.0|-5.2|-1.89||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-1.89|-5.20|<0.0001
70948358|NCT02272244|141397741|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.88|TWO_SIDED|95.0|-0.47|0.55|||Regression, Linear|Model of knowledge test score adjusts for all baseline covariates|Model compares DSNI to SI.|||.55|-.47|0.880
70948359|NCT03670277|141397742|OTHER|Statistically significance of difference. Statistical difference will be concluded if the lower limit was greater than 0 or the upper limit was less than 0.|Least Square Mean Difference|-0.013|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.081|0.056|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|This was a pilot study for assessing the investigational test articles. As such, the sample size was not determined based on any power analysis with regard to the primary endpoint.||0.056|-0.081|
70948360|NCT03670277|141397743|OTHER|Statistically significance of difference. Statistical difference will be concluded if the lower limit was greater than 0 or the upper limit was less than 0.|Least Square Mean Difference|0.031|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.037|0.1|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|This was a pilot study for assessing the investigational test articles. As such, the sample size was not determined based on any power analysis with regard to the primary endpoint.||0.100|-0.037|
70948361|NCT03670277|141397744|OTHER|Statistically significance of difference. Statistical difference would be concluded if the lower limit was greater than 0 or the upper limit was less than 0.|Least Square Mean Difference|3.403|STANDARD_ERROR_OF_MEAN|0.431|||TWO_SIDED|95.0|2.557|4.248|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|At -30°||4.248|2.557|
70948362|NCT03670277|141397744|OTHER|Statistically significance of difference. Statistical difference would be concluded if the lower limit was greater than 0 or the upper limit was less than 0.|Least Square Mean Difference|2.431|STANDARD_ERROR_OF_MEAN|0.431|||TWO_SIDED|95.0|1.585|3.277|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|At +30°||3.277|1.585|
70948363|NCT03670277|141397745|OTHER|Statistically significance of difference. Statistical difference would be concluded if the lower limit was greater than 0 or the upper limit was less than 0.|Least Square Mean Difference|3.039|STANDARD_ERROR_OF_MEAN|0.603|||TWO_SIDED|95.0|1.854|4.225|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean Difference was calculated as Test - Control|At -30°||4.225|1.854|
70948364|NCT03670277|141397745|OTHER|Statistically significance of difference. Statistical difference would be concluded if the lower limit was greater than 0 or the upper limit was less than 0.|Least Square Mean Difference|1.414|STANDARD_ERROR_OF_MEAN|0.603|||TWO_SIDED|95.0|0.228|2.599|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean Difference was calculated as Test - Control|At +30°||2.599|0.228|
70948365|NCT03733899|141397783|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-Square Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|4.96|||TWO_SIDED|95.0|-7.3|12.4|||Linear Mixed Model||Difference was calculated as Test - Placebo|5-Mintues Post Treatment||12.4|-7.3|
71139587|NCT03192176|141778513|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.84||0.0058||95.0|-4.0|-0.68||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.68|-4.00|0.0058
71139588|NCT03192176|141778513|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.82||0.0003|TWO_SIDED|95.0|-4.65|-1.41||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-1.41|-4.65|0.0003
71139589|NCT03192176|141778513|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.84||0.0042|TWO_SIDED|95.0|-4.06|0.76||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||0.76|-4.06|0.0042
71139590|NCT03192176|141778514|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.75||0.0154|TWO_SIDED|95.0|-3.3|-0.35||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.35|-3.30|0.0154
71139591|NCT03192176|141778514|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.74||0.0043|TWO_SIDED|95.0|-3.6|-0.67||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.67|-3.60|0.0043
71139592|NCT03192176|141778514|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.75||0.0023|TWO_SIDED|95.0|-3.76|-0.83||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.83|-3.76|0.0023
71139593|NCT03192176|141778514|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.75||0.0005|TWO_SIDED|95.0|-4.09|-1.16||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-1.16|-4.09|0.0005
71139594|NCT03192176|141778514|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.75||0.0064|TWO_SIDED|95.0|-3.52|-0.58||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.58|-3.52|0.0064
70948366|NCT03733899|141397783|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|-9.6|11.5|||Linear Mixed Model||Difference was calculated as Test - Placebo|10-Minutes Post Treatment||11.5|-9.6|
71139595|NCT03192176|141778514|SUPERIORITY||-2.6|-2.6|STANDARD_ERROR_OF_MEAN|0.74||0.0005|TWO_SIDED|95.0|-4.04|-1.15||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-1.15|-4.04|0.0005
71139596|NCT03192176|141778514|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.75||0.0063|TWO_SIDED|95.0|-3.52|-0.59||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.59|-3.52|0.0063
71139597|NCT03192176|141778515|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.0215|TWO_SIDED|95.0|-0.84|-0.07||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.07|-0.84|0.0215
71139598|NCT03192176|141778515|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0017|TWO_SIDED|95.0|-1.01|-0.24||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.24|-1.01|0.0017
71139599|NCT03192176|141778515|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.21|-0.44||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.44|-1.21|<0.0001
70948367|NCT03733899|141397783|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-Square Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|4.67|||TWO_SIDED|95.0|-8.2|9.8|||Linear Mixed Model||difference was calculated as Test - Placebo.|5-Minutes Post Treatment||9.8|-8.2|
70948368|NCT03733899|141397783|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|4.67|||TWO_SIDED|95.0|-6.5|12.2|||Linear Mixed Model||Difference was calculated as Test - Placebo.|10-Mintues Post Treatment||12.2|-6.5|
70948369|NCT03733899|141397783|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|4.37|||TWO_SIDED|95.0|-5.7|11.7|||Linear Mixed Model||Difference was calculated as Test - Placebo.|5-Mintues Post Treatment||11.7|-5.7|
70948370|NCT03733899|141397783|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-sqaure Mean Difference|7.7|STANDARD_ERROR_OF_MEAN|4.54|||TWO_SIDED|95.0|-1.4|16.8|||Linear Mixed Model||difference was calculated as Test - Placebo.|10-Mintues Post Treatment||16.8|-1.4|
70948371|NCT03733899|141397784|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-Square Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|6.22|||TWO_SIDED|95.0|-10.3|14.4|||Linear Mixed Model||Difference was calculated as Test - Placebo|5-Mintues Post Treatment||14.4|-10.3|
70948372|NCT03733899|141397784|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|6.3|||TWO_SIDED|95.0|-12.1|12.9|||Linear Mixed Model||Difference was calculated as Test - Placebo|10-Minutes Post Treatment||12.9|-12.1|
70948373|NCT03733899|141397784|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-Square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|5.92|||TWO_SIDED|95.0|-11.4|12.1|||Linear Mixed Model||difference was calculated as Test - Placebo.|5-Minutes Post Treatment||12.1|-11.4|
70948374|NCT03733899|141397784|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|5.83|||TWO_SIDED|95.0|-9.2|14.0|||Linear Mixed Model||Difference was calculated as Test - Placebo.|10-Mintues Post Treatment||14.0|-9.2|
70948375|NCT03733899|141397784|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|5.76|||TWO_SIDED|95.0|-8.5|14.3|||Linear Mixed Model||Difference was calculated as Test - Placebo.|5-Mintues Post Treatment||14.3|-8.5|
70948376|NCT03733899|141397784|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-sqaure Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|5.67|||TWO_SIDED|95.0|-3.7|18.8|||Linear Mixed Model||difference was calculated as Test - Placebo.|10-Mintues Post Treatment||18.8|-3.7|
71139600|NCT03192176|141778515|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.37|-0.59||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.59|-1.37|<0.0001
70948377|NCT03733899|141397785|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|4.61|||TWO_SIDED|95.0|-13.2|5.1|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean difference was calculated as (5-min Post-Treatment MINUS Immediate Post-insertion).|5.1|-13.2|
71139601|NCT03192176|141778515|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0322|TWO_SIDED|95.0|-0.81|-0.04||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.04|-0.81|0.0322
71139602|NCT03192176|141778515|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.19||0.0017|TWO_SIDED|95.0|-0.99|-0.23||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.23|-0.99|0.0017
70948378|NCT03733899|141397785|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|4.85|||TWO_SIDED|95.0|-13.9|5.3|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean difference was calculated as (10-min Post-Treatment MINUS Immediate Post-insertion).|5.3|-13.9|
70948379|NCT03733899|141397785|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-16.4|STANDARD_ERROR_OF_MEAN|4.04|||TWO_SIDED|95.0|-24.4|-8.3|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean difference was calculated as (5-min Post-Treatment MINUS Immediate Post-insertion).|-8.3|-24.4|
70948380|NCT03733899|141397785|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|4.14|||TWO_SIDED|95.0|-17.8|-1.4|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean difference was calculated as (10-min Post-Treatment MINUS Immediate Post-insertion).|-1.4|-17.8|
70948381|NCT03733899|141397785|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-12.3|STANDARD_ERROR_OF_MEAN|4.15|||TWO_SIDED|95.0|-20.6|-4.1|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean difference was calculated as (5-min Post-Treatment MINUS Immediate Post-insertion).|-4.1|-20.6|
70864912|NCT02758171|141215725|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence acceptable range of 80.00% to 125.00%.|Adjusted geometric mean (gMean) ratio|101.71|STANDARD_DEVIATION|5.8|<|0.0001|TWO_SIDED|90.0|99.818|103.644|||ANOVA||"The ratio \[%\] calculated as T \[FDC (10 mg Empagliflozin and 5 mg Linagliptin)\]/R \[Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets\].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.||103.644|99.818|<0.0001
70864913|NCT02758171|141215726|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence acceptable range of 80.00% to 125.00%.|Adjusted geometric mean (gMean) ratio|99.39|STANDARD_DEVIATION|13.1|<|0.0001|TWO_SIDED|90.0|95.29|103.672|||ANOVA||"The ratio \[%\] calculated as T \[FDC (10 mg Empagliflozin and 5 mg Linagliptin)\]/R \[Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets\].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.||103.672|95.290|<0.0001
70864914|NCT02758171|141215727|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence acceptable range of 80.00% to 125.00%.|Adjusted geometric mean (gMean) ratio|102.33|STANDARD_DEVIATION|13.6|<|0.0001|TWO_SIDED|90.0|97.945|106.91|||ANOVA||"The ratio \[%\] calculated as T \[FDC (10 mg Empagliflozin and 5 mg Linagliptin)\]/R \[Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets\].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.||106.910|97.945|<0.0001
70864915|NCT02758171|141215728|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence acceptable range of 80.00% to 125.00%.|Adjusted geometric mean (gMean) ratio|107.51|STANDARD_DEVIATION|27.4||0.0027|TWO_SIDED|90.0|98.561|117.282|||ANOVA||"The ratio \[%\] calculated as T \[FDC (10 mg Empagliflozin and 5 mg Linagliptin)\]/R \[Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets\].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.||117.282|98.561|0.0027
70864916|NCT02758171|141215729|SUPERIORITY_OR_OTHER||Adjusted geometric mean (gMean) ratio|101.44|STANDARD_DEVIATION|5.7|||TWO_SIDED|90.0|99.574|103.336|||ANOVA||"The ratio \[%\] calculated as T \[FDC (10 mg Empagliflozin and 5 mg Linagliptin)\]/R \[Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets\].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.||103.336|99.574|
70864917|NCT02758171|141215730|SUPERIORITY_OR_OTHER||Adjusted geometric mean (gMean) ratio|98.15|STANDARD_DEVIATION|15.2|||TWO_SIDED|90.0|93.456|103.082|||ANOVA||"The ratio \[%\] calculated as T \[FDC (10 mg Empagliflozin and 5 mg Linagliptin)\]/R \[Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets\].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.||103.082|93.456|
70864918|NCT00986830|141215783|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value of \<0.05 was considered statistically significant.|t-test, 2 sided||||A reduction in SNOT-20 score of 0.8 or more is considered clinically meaningful.|||<0.0001
70864919|NCT00986830|141215784|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 is considered statistically significant.|t-test, 2 sided|||||||<0.0001
70864920|NCT00986830|141215785|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 is considered statistically significant.|t-test, 2 sided|||||||<0.0001
70864921|NCT00986830|141215786|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 is considered statistically significant.|t-test, 2 sided|||||||<0.0001
70864922|NCT00986830|141215787|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 is considered statistically significant.|t-test, 2 sided|||||||<0.0001
70864923|NCT00986830|141215788|SUPERIORITY|||||||0.009||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 indicates statistical significance.|t-test, 2 sided|||||||0.009
70948382|NCT03733899|141397785|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-8.2|STANDARD_ERROR_OF_MEAN|4.25|||TWO_SIDED|95.0|-16.7|0.2|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean difference was calculated as (10-min Post-Treatment MINUS Immediate Post-insertion).|0.2|-16.7|
70948383|NCT03733899|141397786|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|5.07|||TWO_SIDED|95.0|-8.7|11.6|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Lower Lid Margin|11.6|-8.7|
71139603|NCT03192176|141778515|SUPERIORITY||LSMean differencce|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0004|TWO_SIDED|95.0|-1.08|-0.31||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.31|-1.08|0.0004
71139604|NCT03192176|141778516|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.2324|TWO_SIDED|95.0|-0.67|-0.16||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.16|-0.67|0.2324
71139605|NCT03192176|141778516|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0736|TWO_SIDED|95.0|-0.8|0.04||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||0.04|-0.80|0.0736
71139606|NCT03192176|141778516|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.21||0.008|TWO_SIDED|95.0|-0.98|-0.15||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.15|-0.98|0.0080
71139607|NCT03192176|141778516|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.21||0.0028|TWO_SIDED|95.0|-1.07|-0.22||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.22|-1.07|0.0028
70864924|NCT00986830|141215789|SUPERIORITY|||||||0.292||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 indicates statistical significance.|t-test, 2 sided|||||||0.292
71139608|NCT03192176|141778516|SUPERIORITY||LSMean differnce|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.4647|TWO_SIDED|95.0|-0.58|0.26||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||0.26|-0.58|0.4647
71139609|NCT03192176|141778516|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.016|TWO_SIDED|95.0|-0.92|-0.1||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.10|-0.92|0.0160
71139610|NCT03192176|141778516|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0901|TWO_SIDED|95.0|-0.78|0.06||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||0.06|-0.78|0.0901
71139611|NCT03192176|141778517|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.79||0.0865|TWO_SIDED|95.0|-2.92|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|MMRM: Mixed Model Repeated Measures||Week 1||0.20|-2.92|0.0865
71139612|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.79||0.0009|TWO_SIDED|95.0|-4.22|-1.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.10|-4.22|0.0009
71139613|NCT03192176|141778517|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|0.79|<|1e-05|TWO_SIDED|95.0|-5.06|-1.94||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.94|-5.06|<0.00001
71139614|NCT03192176|141778517|SUPERIORITY||LSMean difference|-4.0|STANDARD_ERROR_OF_MEAN|0.8|<|1e-05|TWO_SIDED|95.0|-5.63|-2.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-2.47|-5.63|<0.00001
71139615|NCT03192176|141778517|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.81||0.236|TWO_SIDED|95.0|-2.55|0.63||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||0.63|-2.55|0.2360
71139616|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|-2.4||0.0032|TWO_SIDED|95.0|-3.92|-0.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.80|-3.92|0.0032
71139617|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.79||0.0006|TWO_SIDED|95.0|-4.29|-1.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.19|-4.29|0.0006
71139618|NCT03192176|141778517|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.82||0.1318|TWO_SIDED|95.0|-2.86|0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||0.38|-2.86|0.1318
71139619|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.83||0.0014|TWO_SIDED|95.0|-4.3|-1.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-1.04|-4.30|0.0014
71139620|NCT03192176|141778517|SUPERIORITY||LSMean differencce|-3.2|STANDARD_ERROR_OF_MEAN|0.82||0.0001|TWO_SIDED|95.0|-4.82|-1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-1.58|-4.82|0.0001
71139621|NCT03192176|141778517|SUPERIORITY||LSMean difference|-3.6|STANDARD_ERROR_OF_MEAN|0.84|<|0.0001|TWO_SIDED|95.0|-5.3|-2.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-2.00|-5.30|<0.0001
71139622|NCT03192176|141778517|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.84||0.0752|TWO_SIDED|95.0|-3.15|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||0.15|-3.15|0.0752
71139623|NCT03192176|141778517|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.83||0.0343|TWO_SIDED|95.0|-3.38|-0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.13|-3.38|0.0343
70948384|NCT03733899|141397786|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|8.5|STANDARD_ERROR_OF_MEAN|4.77|||TWO_SIDED|95.0|-1.0|18.0|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Lower Lid Margin|18.0|-1.0|
70948385|NCT03733899|141397786|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|6.8|STANDARD_ERROR_OF_MEAN|5.12|||TWO_SIDED|95.0|-3.5|17.0|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Upper Lid Margin|17.0|-3.5|
70948386|NCT03733899|141397786|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Mean Difference (Final Values)|11.2|STANDARD_ERROR_OF_MEAN|4.82|||TWO_SIDED|95.0|1.6|20.8|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Upper Lid Margin|20.8|1.6|
70948387|NCT03733899|141397787|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|6.12|||TWO_SIDED|95.0|-11.4|12.9|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Lower Lid Margin: 10-mintues post treatment - Pre Treatment.|12.9|-11.4|
71139624|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.82||0.0049|TWO_SIDED|95.0|-3.95|-0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.71|-3.95|0.0049
70948388|NCT03733899|141397787|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|7.8|STANDARD_ERROR_OF_MEAN|6.1|||TWO_SIDED|95.0|-4.9|19.9|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Lower Lid Margin: 5-mintues post treatment - Pre Treatment.|19.9|-4.9|
71139625|NCT03192176|141778517|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.84||0.0285|TWO_SIDED|95.0|-3.5|-0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.20|-3.50|0.0285
71139626|NCT03192176|141778517|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.85||0.0004|TWO_SIDED|95.0|-4.69|-1.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.37|-4.69|0.0004
71139627|NCT03192176|141778517|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|0.85|<|0.0001|TWO_SIDED|95.0|-5.14|-1.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.84|-5.14|<0.0001
71139628|NCT03192176|141778517|SUPERIORITY||LSMean difference|-4.0|STANDARD_ERROR_OF_MEAN|0.86|<|0.0001|TWO_SIDED|95.0|-5.65|-2.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRm|||Week 3||-2.28|-5.65|<0.0001
71139629|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.86||0.0169|TWO_SIDED|95.0|-3.74|-0.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.37|-3.74|0.0169
71139630|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.84||0.0049|TWO_SIDED|95.0|-4.04|-0.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.73|-4.04|0.0049
71139631|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.84||0.0008|TWO_SIDED|95.0|-4.48|-1.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.18|-4.48|0.0008
71139632|NCT03192176|141778517|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.84||0.0428|TWO_SIDED|95.0|-3.36|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.06|-3.36|0.0428
71139633|NCT03192176|141778517|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.84||0.0004|TWO_SIDED|95.0|-4.65|-1.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-1.34|-4.65|0.0004
71139634|NCT03192176|141778517|SUPERIORITY||LSMean difference|-3.2|STANDARD_ERROR_OF_MEAN|-0.84||1e-05|TWO_SIDED|95.0|-4.88|-1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-1.58|-4.88|0.00001
70948389|NCT03733899|141397787|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|6.19|||TWO_SIDED|95.0|-9.3|15.2|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Upper Lid Margin: 10-mintues post treatment - Pre Treatment.|15.2|-9.3|
70948390|NCT03733899|141397787|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Mean Difference (Final Values)|7.4|STANDARD_ERROR_OF_MEAN|6.17|||TWO_SIDED|95.0|-4.9|19.6|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Upper Lid Margin: 5-mintues post treatment - Pre Treatment.|19.6|-4.9|
70864925|NCT00986830|141215790|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 indicates statistical significance.|t-test, 2 sided|||||||<0.0001
70864926|NCT00074984|141215817|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.574||||0.1449|TWO_SIDED|95.0|0.269|1.222|||Log Rank|Comparison is based on a 2-sided log-rank test.||||1.222|0.269|0.1449
70864927|NCT00074984|141215817|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.465||||0.0577|TWO_SIDED|95.0|0.211|1.025|||Wald Test|||Time to First Primary Endpoint Adjusting for Baseline Proteinuria using Cox Proportional Hazards Model||1.025|0.211|0.0577
70864928|NCT00074984|141215818|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.732||||0.5261|TWO_SIDED|95.0|0.278|1.927|||Log Rank|2-sided log-rank test||Analysis of Time to First Renal Event for ITT population.||1.927|0.278|0.5261
70864929|NCT01254292|141215877|SUPERIORITY_OR_OTHER||single proportion|82.1|||||TWO_SIDED|95.0|77.1|86.5|||||Clopper Pearson Confidence Interval|||86.5|77.1|
70864930|NCT01254292|141215877|SUPERIORITY_OR_OTHER||single proportion|81.9|||||TWO_SIDED|95.0|76.7|86.4|||||Clopper Pearson Confidence Interval|||86.4|76.7|
70864931|NCT04041375|141215908|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.09||||0.42|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Total Score - Treatment Effect - Month 3||||0.42
70864932|NCT04041375|141215908|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.13||||0.32|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Emotional Burden Subscale - Treatment Effect - Month 3||||0.32
70864933|NCT04041375|141215908|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.13||||0.36|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Physician-Related Distress Subscale - Treatment Effect - Month 3||||0.36
70864934|NCT04041375|141215908|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.17||||0.23|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Regimen-Related Distress Subscale - Treatment Effect - Month 3||||0.23
70864935|NCT04041375|141215908|SUPERIORITY|Treatment effect was modeled via multilevel linear regression model with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.18||||0.26|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Interpersonal Distress Subscale - Treatment Effect - Month 3||||0.26
71139635|NCT03192176|141778517|SUPERIORITY||LSMean difference|-4.1|STANDARD_ERROR_OF_MEAN|0.85|<|0.0001|TWO_SIDED|95.0|-5.73|-2.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-2.37|-5.73|<0.0001
71139636|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.85||0.0225|TWO_SIDED|95.0|-3.64|-0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.28|-3.64|0.0225
71139637|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.84||0.0008|TWO_SIDED|95.0|-4.49|-1.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-1.19|-4.49|0.0008
70864936|NCT04041375|141215908|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Treatment Effect|0.007||||0.95|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Total Score - Treatment Effect - Month 6||||0.95
70864937|NCT04041375|141215908|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.01||||0.92|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Emotional Burden Subscale - Treatment Effect - Month 6||||0.92
70864938|NCT04041375|141215908|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.07||||0.59|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Physician-Related Distress Subscale - Treatment Effect - Month 6||||0.59
70948391|NCT03733899|141397788|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|-12.4|STANDARD_ERROR_OF_MEAN|4.22|||TWO_SIDED|95.0|-20.9|-3.9|||Mixed Models Analysis||||mean difference was calculated as postremoval minus pre-insertion with Test and corneal region.|-3.9|-20.9|
70948392|NCT02104505|141397807|SUPERIORITY||Mean Difference (Net)|0.41|STANDARD_ERROR_OF_MEAN|0.18||0.04|TWO_SIDED||||||Mixed Models Analysis||Comparison of change in sputum %PMNs during active treatment vs placebo (crossover design).|||||0.04
70948393|NCT02104505|141397808|SUPERIORITY||Mean Difference (Net)|0.64|STANDARD_ERROR_OF_MEAN|0.22||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.01
70948394|NCT02104505|141397809|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.33||0.6|TWO_SIDED||||||Mixed Models Analysis|||||||0.6
70948395|NCT02104505|141397810|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.33||0.34|TWO_SIDED||||||Mixed Models Analysis|||||||0.34
70948396|NCT00013611|141397870|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.47|TWO_SIDED|95.0|0.7|1.18|||Regression, Cox|Stratification by CD4+ count stratum (50-199 or 200-299) and country of randomization.||Null hypothesis was that event rates in two groups are equal. Study was designed with 80%, two-sided alpha=.05, assuming a 28% reduction in the hazard of opportunistic disease or death.||1.18|0.70|0.47
70948397|NCT00013611|141397871|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.73|TWO_SIDED|95.0|0.77|1.44|||Regression, Cox|Stratification by CD4+ stratum and country of randomization.||||1.44|0.77|0.73
70948398|NCT00013611|141397872|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.1|TWO_SIDED|95.0|0.51|1.06|||Regression, Cox|Stratification by CD4+ stratum and country of randomization.||||1.06|0.51|0.10
70948399|NCT00013611|141397873|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.35|TWO_SIDED|95.0|0.9|1.34|||Regression, Cox|||||1.34|0.90|0.35
70948400|NCT00013611|141397874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.0|STANDARD_ERROR_OF_MEAN|6.5|<|0.001|TWO_SIDED|95.0|40.3|65.7|||Mixed Models Analysis|||||65.7|40.3|< 0.001
70948401|NCT02431052|141397876|OTHER|||||||0.0006|||||||Cochran-Mantel-Haenszel|ANCOVA with factors of treatment group (combined vehicle as one group) and baseline count as covariate.||||||0.0006
70948402|NCT02431052|141397877|OTHER|||||||0.0002|||||||Cochran-Mantel-Haenszel|ANCOVA with factors of treatment group (combined vehicle as one group) and baseline count as covariate.||||||0.0002
70948403|NCT02431052|141397878|OTHER|||||||0.0055|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test (vehicle treatment groups included as single combined treatment group).||||||0.0055
70948404|NCT02094898|141397879|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
70948405|NCT02094898|141397879|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.05
70948406|NCT02094898|141397880|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.001
70948407|NCT02094898|141397881|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
70948408|NCT02094898|141397881|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
70948409|NCT02094898|141397881|SUPERIORITY||||||<|0.08|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.08
70948410|NCT02094898|141397882|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.001
70948411|NCT02094898|141397883|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
70948412|NCT02094898|141397883|SUPERIORITY||||||<|0.08|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.08
70948413|NCT02094898|141397884|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
70864939|NCT04041375|141215908|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.08||||0.54|TWO_SIDED|||||alpha = 0.05|Interaction Term|||Regimen-Related Distress Subscale - Treatment Effect - Month 6||||0.54
70864940|NCT04041375|141215908|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.3||||0.05|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Interpersonal Distress Subscale - Treatment Effect - Month 6||||0.05
70864941|NCT04041375|141215909|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.58||||0.03|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||General Diet - Treatment Effect - Month 3||||0.03
70864942|NCT04041375|141215909|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.07||||0.83|TWO_SIDED||||||Mixed Models Analysis|||Specific Diet (Fruits and Vegetables) - Treatment Effect - Month 3||||0.83
70864943|NCT04041375|141215909|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.44||||0.12|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Specific Diet (Fat) - Treatment Effect - Month 3||||0.12
70864944|NCT04041375|141215909|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.39||||0.17|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Physical Activity - Treatment Effect - Month 3||||0.17
70864945|NCT04041375|141215909|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.06||||0.85|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Blood Glucose Testing - Treatment Effect - Month 3||||0.85
70864946|NCT04041375|141215909|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.02||||0.94|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Foot Care - Treatment Effect - Month 3||||0.94
70948414|NCT02094898|141397885|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
70948415|NCT02094898|141397885|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
70948416|NCT02094898|141397886|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
70948417|NCT02094898|141397887|SUPERIORITY||||||<|0.08|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.08
70948418|NCT02094898|141397887|SUPERIORITY||||||<|0.08|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.08
70948419|NCT02094898|141397888|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.001
70948420|NCT02094898|141397889|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.05
70948421|NCT02094898|141397889|SUPERIORITY||||||<|0.08|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.08
70948422|NCT02094898|141397890|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.001
70948423|NCT02094898|141397891|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
70948424|NCT02094898|141397891|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
70948425|NCT03520075|141397903|SUPERIORITY||Geometric Least Squares Mean (Geo LSM)|27.8|||||TWO_SIDED|90.0|8.5|91.2|||||Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.|Comparison of effect of food on AUC0-24 between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C1D1.||91.2|8.50|
70948426|NCT03520075|141397903|SUPERIORITY||Geo LSM|38.8|||||TWO_SIDED|90.0|11.4|132.0|||||Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.|Comparison of effect of food on AUC0-24 between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C2D1.||132|11.4|
70948427|NCT03520075|141397903|SUPERIORITY||Geo LSM|58.9|||||TWO_SIDED|90.0|15.7|222.0|||||Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.|Comparison of effect of food on AUC0-24 between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C1D1.||222|15.7|
70948428|NCT03520075|141397903|SUPERIORITY||Geo LSM|47.2|||||TWO_SIDED|90.0|20.7|108.0|||||Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.|Comparison of effect of food on AUC0-24 between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C2D1.||108|20.7|
70948429|NCT03520075|141397904|SUPERIORITY||Geo LSM|18.1|||||TWO_SIDED|90.0|5.28|61.9|||||Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.|Comparison of effect of food on AUC0-inf between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C1D1.||61.9|5.28|
70948430|NCT03520075|141397904|SUPERIORITY||Geo LSM|44.1|||||TWO_SIDED|90.0|8.32|234.0|||||Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.|Comparison of effect of food on AUC0-inf between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C2D1.||234|8.32|
70948431|NCT03520075|141397904|SUPERIORITY||Geo LSM|58.7|||||TWO_SIDED|90.0|15.7|220.0|||||Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.|Comparison of effect of food on AUC0-inf between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C1D1.||220|15.7|
71139638|NCT03192176|141778517|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.84||0.0003|TWO_SIDED|95.0|-4.7|-1.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-1.42|-4.70|0.0003
71139639|NCT03192176|141778517|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.79||0.1168|TWO_SIDED|95.0|-2.8|0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||0.31|-2.80|0.1168
70948432|NCT03520075|141397904|SUPERIORITY||Geo LSM|40.2|||||TWO_SIDED|90.0|14.3|113.0|||||Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.|Comparison of effect of food on AUC0-inf between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C2D1.||113|14.3|
70948433|NCT03520075|141397905|SUPERIORITY||Geo LSM|17.5|||||TWO_SIDED|90.0|5.62|54.3|||||Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.|Comparison of effect of food on Cmax between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C1D1.||54.3|5.62|
70948434|NCT03520075|141397905|SUPERIORITY||Geo LSM|34.5|||||TWO_SIDED|90.0|12.0|99.4|||||Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.|Comparison of effect of food on Cmax between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C2D1.||99.4|12.0|
70948435|NCT03520075|141397905|SUPERIORITY||Geo LSM|72.6|||||TWO_SIDED|90.0|17.6|299.0|||||Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.|Comparison of effect of food on Cmax between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C1D1.||299|17.6|
70864947|NCT04041375|141215909|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.19||||0.47|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||General Diet - Treatment Effect - Month 6||||0.47
70864948|NCT04041375|141215909|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.08||||0.82|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Specific Diet (Fruits and Vegetables) - Treatment Effect - Month 6||||0.82
70864949|NCT04041375|141215909|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.13||||0.66|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Specific Diet (Fat) - Treatment Effect - Month 6||||0.66
70864950|NCT04041375|141215909|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.25||||0.38|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Physical Activity - Treatment Effect - Month 6||||0.38
70864951|NCT04041375|141215909|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.12||||0.68|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Blood Glucose Testing - Treatment Effect - Month 6||||0.68
70864952|NCT04041375|141215909|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.26||||0.4|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Foot Care - Treatment Effect - Month 6||||0.40
70864953|NCT04041375|141215911|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.06||||0.93|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 3||||0.93
70864954|NCT04041375|141215911|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.63||||0.38|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 6||||0.38
70864955|NCT04041375|141215912|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.32||||0.66|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 3||||0.66
70864956|NCT04041375|141215912|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.99||||0.18|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 6||||0.18
70864957|NCT04041375|141215915|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|1.45||||0.38|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 3||||0.38
70864958|NCT04041375|141215915|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|1.64||||0.68|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 6||||0.68
71139640|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.79||0.0012|TWO_SIDED|95.0|-4.15|-1.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.03|-4.15|0.0012
70864959|NCT04041375|141215916|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.19||||0.74|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 3||||0.74
70864960|NCT04041375|141215916|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.29||||0.62|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 6||||0.62
70864961|NCT04041375|141215917|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.16||||0.72|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 3||||0.72
70864962|NCT04041375|141215917|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.24||||0.58|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 6||||0.58
70948436|NCT03520075|141397905|SUPERIORITY||Geo LSM|72.5|||||TWO_SIDED|90.0|29.1|181.0|||||Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.|Comparison of effect of food on Cmax between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C1D1.||181|29.1|
70948437|NCT03520075|141397906|SUPERIORITY||Hodges-Lehmann Estimator|-2.275||||0.0388671|TWO_SIDED|90.0|-5.216|-0.083|||Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator and 90% confidence interval (CI) was calculated using the Moses approximation.|Comparison of effect of food on Tmax between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C1D1.||-0.0830|-5.2160|0.0388671
70948438|NCT03520075|141397906|SUPERIORITY||Hodges-Lehmann Estimator|1.45||||0.4795001|TWO_SIDED|90.0|-0.917|5.15|||Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator and 90% CI was calculated using the Moses approximation.|Comparison of effect of food on Tmax between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C2D1.||5.1500|-0.9170|0.4795001
70948439|NCT03520075|141397906|SUPERIORITY||Hodges-Lehmann Estimator|-0.45||||0.8272593|TWO_SIDED|90.0|-2.467|0.95|||Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator and 90% CI was calculated using the Moses approximation.|Comparison of effect of food on Tmax between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C1D1.||0.9500|-2.4670|0.8272593
70864963|NCT04041375|141215918|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.36||||0.5|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 3||||0.50
70864964|NCT04041375|141215918|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.72||||0.18|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 6||||0.18
70864965|NCT01967342|141215927|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.268|STANDARD_ERROR_OF_MEAN|-0.193||0.165|TWO_SIDED||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within Usual Care between pre-treatment and 10-week post-treatment.||||.165
70864966|NCT01967342|141215927|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.245|STANDARD_ERROR_OF_MEAN|0.198||0.216|TWO_SIDED||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within Usual Care between post-treatment and 6-month follow-up.||||.216
70864967|NCT01967342|141215927|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.052|STANDARD_ERROR_OF_MEAN|0.189|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within CBT group between the pre-treatment and 10-week post-treatment.||||< .001
70864968|NCT01967342|141215927|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.361|STANDARD_ERROR_OF_MEAN|0.199||0.07|TWO_SIDED||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within CBT group between the post-treatment and 6-month follow-up.||||.070
70864969|NCT01967342|141215927|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.823|STANDARD_ERROR_OF_MEAN|0.191|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within Pain Ed group between the pre-treatment and 10-week post-treatment.||||< .001
70948440|NCT03520075|141397906|SUPERIORITY||Hodges-Lehmann Estimator|0.583||||0.5126908|TWO_SIDED|90.0|-6.45|3.5|||Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator and 90% CI was calculated using the Moses approximation.|Comparison of effect of food on Tmax between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C2D1.||3.5000|-6.4500|0.5126908
70948441|NCT01234883|141397927|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70948442|NCT01013961|141397945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.722|TWO_SIDED||||||Fisher Exact|||||||0.722
70948443|NCT01013961|141397946|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0
70948444|NCT01375751|141397965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.82|STANDARD_ERROR_OF_MEAN|3.92|<|0.001|TWO_SIDED|95.0|-51.56|-36.09||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference.|The null hypothesis was that there was no mean difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo.||-36.09|-51.56|<0.001
70948445|NCT01375751|141397965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.36|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|95.0|-64.06|-48.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo.||-48.67|-64.06|<0.001
71139641|NCT03192176|141778517|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.79||0.0002|TWO_SIDED|95.0|-4.54|-1.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.42|-4.54|0.0002
71139642|NCT03192176|141778517|SUPERIORITY||LSMean difference|-3.9|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|TWO_SIDED|95.0|-5.44|-2.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-2.28|-5.44|<0.0001
71139643|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.8||0.0134|TWO_SIDED|95.0|-3.58|-0.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.42|-3.58|0.0134
71139644|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.79||0.0057|TWO_SIDED|95.0|-3.76|-0.65||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.65|-3.76|0.0057
71139645|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.79||0.0016|TWO_SIDED|95.0|-4.06|-0.96||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.96|-4.06|0.0016
71139646|NCT03192176|141778517|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.79||0.0843|TWO_SIDED|95.0|-2.94|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||0.19|-2.94|0.0843
71139647|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.8||0.0035|TWO_SIDED|95.0|-3.9|-0.77||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.77|-3.90|0.0035
71139648|NCT03192176|141778517|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.8||0.0001|TWO_SIDED|95.0|-4.66|-1.52||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.52|-4.66|0.0001
71139649|NCT03192176|141778517|SUPERIORITY||LSMean difference|-3.7|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-5.28|-2.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-2.10|-5.28|<0.0001
71139650|NCT03192176|141778517|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.81||0.0315|TWO_SIDED|95.0|-3.33|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.16|-3.33|0.0315
71139651|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.8||0.0063|TWO_SIDED|95.0|-3.75|-0.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.62|-3.75|0.0063
71139652|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.79||0.0007|TWO_SIDED|95.0|-4.25|-1.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.14|-4.25|0.0007
71139653|NCT03192176|141778517|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.81||0.109|TWO_SIDED|95.0|-2.89|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||0.29|-2.89|0.1090
71139654|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.81||0.0018|TWO_SIDED|95.0|-4.14|-0.95||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.95|-4.14|0.0018
71139655|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|0.81||0.0004|TWO_SIDED|95.0|-4.54|-1.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-1.34|-4.54|0.0004
71139656|NCT03192176|141778517|SUPERIORITY||LSMean difference|-3.8|STANDARD_ERROR_OF_MEAN|0.83|<|0.0001|TWO_SIDED|95.0|-5.4|-2.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-2.15|-5.40|<0.0001
71139657|NCT03192176|141778517|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.82||0.0231|TWO_SIDED|95.0|-3.5|-0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.26|-3.50|0.0231
70864970|NCT01967342|141215927|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.131|STANDARD_ERROR_OF_MEAN|0.203||0.519|TWO_SIDED||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within Pain Ed group between the post-treatment and 6-month follow-up.||||.519
70864971|NCT01967342|141215928|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|0.247||0.196|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within Usual Care group between the pre-treatment and 10-week post-treatment.||||.196
70948446|NCT01375751|141397966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-65.5|STANDARD_ERROR_OF_MEAN|7.1|<|0.001|TWO_SIDED|95.0|-79.6|-51.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-51.4|-79.6|<0.001
70948447|NCT01375751|141397966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-84.7|STANDARD_ERROR_OF_MEAN|7.1|<|0.001|TWO_SIDED|95.0|-98.8|-70.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-70.7|-98.8|<0.001
71139658|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.81||0.0056|TWO_SIDED|95.0|-3.86|-0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.67|-3.86|0.0056
71139659|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.81||0.0007|TWO_SIDED|95.0|-4.35|-1.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-1.17|-4.35|0.0007
71139660|NCT03192176|141778517|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.81||0.3568|TWO_SIDED|95.0|-2.35|0.85||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.85|-2.35|0.3568
71139661|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.82||0.0129|TWO_SIDED|95.0|-3.65|-0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.43|-3.65|0.0129
71139662|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.82||0.0018|TWO_SIDED|95.0|-4.19|-0.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.97|-4.19|0.0018
71139663|NCT03192176|141778517|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.83||0.0003|TWO_SIDED|95.0|-4.7|-1.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-1.42|-4.70|0.0003
71139664|NCT03192176|141778517|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.83||0.1004|TWO_SIDED|95.0|-3.0|0.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.27|-3.00|0.1004
71139665|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.82||0.0173|TWO_SIDED|95.0|-3.57|-0.35||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.35|-3.57|0.0173
71139666|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.81||0.0038|TWO_SIDED|95.0|-3.97|-0.77||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.77|-3.97|0.0038
71139667|NCT03192176|141778517|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.78||0.1767|TWO_SIDED|95.0|-2.57|0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.48|-2.57|0.1767
71139668|NCT03192176|141778517|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.77||0.0308|TWO_SIDED|95.0|-3.2|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.16|-3.20|0.0308
71139669|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.78||0.0013|TWO_SIDED|95.0|-4.07|-1.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.00|-4.07|0.0013
71139670|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|0.79||0.0003|TWO_SIDED|95.0|-4.47|-1.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.36|-4.47|0.0003
70948448|NCT01375751|141397967|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.79|STANDARD_ERROR_OF_MEAN|3.81|<|0.001|TWO_SIDED|95.0|-49.32|-34.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-34.26|-49.32|<0.001
71139671|NCT03192176|141778517|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.79||0.2109|TWO_SIDED|95.0|-2.55|0.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.56|-2.55|0.2109
71139672|NCT03192176|141778517|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.78||0.0152|TWO_SIDED|95.0|-3.44|-0.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.37|-3.44|0.0152
71139673|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.77||0.0075|TWO_SIDED|95.0|-3.61|-0.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.56|-3.61|0.0075
71139674|NCT03192176|141778517|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.8||0.0869|TWO_SIDED|95.0|-2.96|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||0.20|-2.96|0.0869
71139675|NCT03192176|141778517|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.8||0.052|TWO_SIDED|95.0|-3.14|0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||0.01|-3.14|0.0520
71139676|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.81||0.0009|TWO_SIDED|95.0|-4.3|-1.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-1.12|-4.30|0.0009
71139677|NCT03192176|141778517|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.82||0.0002|TWO_SIDED|95.0|-4.68|-1.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-1.46|-4.68|0.0002
71139678|NCT03192176|141778517|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.82||0.0456|TWO_SIDED|95.0|-3.25|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 10||-0.03|-3.25|0.0456
71139679|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.81||0.0073|TWO_SIDED|95.0|-3.76|-0.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.59|-3.76|0.0073
71139680|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.8||0.0026|TWO_SIDED|95.0|-4.01|-0.86||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.86|-4.01|0.0026
71139681|NCT03192176|141778517|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.78||0.0878|TWO_SIDED|95.0|-2.87|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||0.20|-2.87|0.0878
71139682|NCT03192176|141778517|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.78||0.0182|TWO_SIDED|95.0|-3.39|-0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.32|-3.39|0.0182
71139683|NCT03192176|141778517|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.79||0.0002|TWO_SIDED|95.0|-4.55|-1.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.44|-4.55|0.0002
71139684|NCT03192176|141778517|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.8||0.0002|TWO_SIDED|95.0|-4.53|-1.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.40|-4.53|0.0002
71139685|NCT03192176|141778517|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.8||0.0387|TWO_SIDED|95.0|-3.22|-0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.09|-3.22|0.0387
70948449|NCT01375751|141397967|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-53.46|STANDARD_ERROR_OF_MEAN|3.79|<|0.001|TWO_SIDED|95.0|-60.95|-45.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-45.97|-60.95|<0.001
71139686|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.79||0.0031|TWO_SIDED|95.0|-3.89|-0.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.80|-3.89|0.0031
70864972|NCT01967342|141215928|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.182|STANDARD_ERROR_OF_MEAN|0.239||0.447|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within Usual Care group between the post-treatment and 6-month follow-up.||||.447
70948450|NCT01375751|141397968|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.75|STANDARD_ERROR_OF_MEAN|3.55|<|0.001|TWO_SIDED|95.0|-41.77|-27.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-27.74|-41.77|<0.001
71139687|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.78||0.0029|TWO_SIDED|95.0|-3.88|-0.81||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.81|-3.88|0.0029
71139688|NCT03192176|141778517|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.76||0.0653|TWO_SIDED|95.0|-2.9|0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.09|-2.90|0.0653
71139689|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.76||0.0102|TWO_SIDED|95.0|-3.46|-0.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.47|-3.46|0.0102
71139690|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|0.77||0.0002|TWO_SIDED|95.0|-4.38|-1.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-1.36|-4.38|0.0002
71139691|NCT03192176|141778517|SUPERIORITY||LSMean difference|-3.2|STANDARD_ERROR_OF_MEAN|0.78|<|0.0001|TWO_SIDED|95.0|-4.72|-1.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-1.67|-4.72|<0.0001
71139692|NCT03192176|141778517|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.78||0.0231|TWO_SIDED|95.0|-3.3|-0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.25|-3.30|0.0231
71139693|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.78||0.0021|TWO_SIDED|95.0|-3.88|-0.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.87|-3.88|0.0021
71139694|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.76||0.0021|TWO_SIDED|95.0|-3.88|-0.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.87|-3.88|0.0021
71139695|NCT03192176|141778517|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.76||0.0013|TWO_SIDED|95.0|-3.96|-0.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.97|-3.96|0.0013
71139696|NCT03192176|141778517|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.84||0.146|TWO_SIDED|95.0|-2.89|0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.43|-2.89|0.1460
71139697|NCT03192176|141778517|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.84||0.6066|TWO_SIDED|95.0|-2.1|1.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMMRM|||Week 13||1.23|-2.10|0.6066
71139698|NCT03192176|141778517|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.87||0.8422|TWO_SIDED|95.0|-1.88|1.54||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||1.54|-1.88|0.8422
71139699|NCT03192176|141778517|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.87||0.2346|TWO_SIDED|95.0|-2.74|0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|LSMean difference|||Week 13||0.67|-2.74|0.2346
71139700|NCT03192176|141778517|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.87||0.1128|TWO_SIDED|95.0|-3.11|0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.33|-3.11|0.1128
71139701|NCT03192176|141778517|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.87||0.1811|TWO_SIDED|95.0|-2.89|0.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.55|-2.89|0.1811
70948451|NCT01375751|141397968|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.2|STANDARD_ERROR_OF_MEAN|3.53|<|0.001|TWO_SIDED|95.0|-53.18|-39.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-39.23|-53.18|<0.001
70948452|NCT01375751|141397969|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.66|STANDARD_ERROR_OF_MEAN|3.72|<|0.001|TWO_SIDED|95.0|-44.01|-29.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placbo is the reference|||-29.32|-44.01|<0.001
70948453|NCT01375751|141397969|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.01|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-52.32|-37.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-37.70|-52.32|<0.001
70948454|NCT01375751|141397970|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.92|STANDARD_ERROR_OF_MEAN|3.45|<|0.001|TWO_SIDED|95.0|-40.72|-27.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-27.11|-40.72|<0.001
71139702|NCT03192176|141778517|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.84||0.3521|TWO_SIDED|95.0|-2.45|0.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.87|-2.45|0.3521
71139703|NCT03192176|141778517|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.84||0.357|TWO_SIDED|95.0|-2.44|0.88||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.88|-2.44|0.3570
71139704|NCT03192176|141778517|SUPERIORITY||LSMean differencce|-0.1|STANDARD_ERROR_OF_MEAN|0.84||0.9227|TWO_SIDED|95.0|-1.73|1.57||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.57|-1.73|0.9227
71139705|NCT03192176|141778517|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.87||0.8894|TWO_SIDED|95.0|-1.84|1.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.60|-1.84|0.8894
70948455|NCT01375751|141397970|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.64|STANDARD_ERROR_OF_MEAN|3.43|<|0.001|TWO_SIDED|95.0|-51.41|-37.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-37.86|-51.41|<0.001
70948456|NCT02980523|141397971|NON_INFERIORITY_OR_EQUIVALENCE|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.002|||||||Chi-squared|||||||0.002
70948457|NCT02980523|141397972|NON_INFERIORITY|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.372|||||||Chi-squared, Corrected|||||||0.372
71139706|NCT03192176|141778517|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.87||0.5074|TWO_SIDED|95.0|-2.29|1.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.13|-2.29|0.5074
71139707|NCT03192176|141778517|SUPERIORITY||LSMean differencce|-1.2|STANDARD_ERROR_OF_MEAN|0.87||0.1753|TWO_SIDED|95.0|-2.91|0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.53|-2.91|0.1753
71139708|NCT03192176|141778517|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.88||0.1212|TWO_SIDED|95.0|-3.09|0.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.36|-3.09|0.1212
71139709|NCT03192176|141778517|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.84||0.3702|TWO_SIDED|95.0|-2.41|0.9||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.90|-2.41|0.3702
71139710|NCT03192176|141778517|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|0.81||0.6459|TWO_SIDED|95.0|-1.22|1.96||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.96|-1.22|0.6459
71139711|NCT03192176|141778517|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.8||0.8248|TWO_SIDED|95.0|-1.4|1.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.75|-1.40|0.8248
71139712|NCT03192176|141778517|SUPERIORITY||LSMean difference|0.7|STANDARD_ERROR_OF_MEAN|0.84||0.4226|TWO_SIDED|95.0|-0.98|2.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||2.33|-0.98|0.4226
71139713|NCT03192176|141778517|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|0.83||0.6469|TWO_SIDED|95.0|-1.25|2.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||2.01|-1.25|0.6469
71139714|NCT03192176|141778517|SUPERIORITY||LSMean difference|0.3|STANDARD_ERROR_OF_MEAN|0.84||0.7642|TWO_SIDED|95.0|-1.41|1.91||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.91|-1.41|0.7642
71139715|NCT03192176|141778517|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.84||0.4068|TWO_SIDED|95.0|-2.36|0.966||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.966|-2.36|0.4068
71139716|NCT03192176|141778517|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.8||0.7974|TWO_SIDED|95.0|-1.37|1.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.78|-1.37|0.7974
71139717|NCT03192176|141778518|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.78||0.0297|TWO_SIDED|95.0|-3.23|-0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.17|-3.23|0.0297
71139718|NCT03192176|141778518|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.78|<|0.0001|TWO_SIDED|95.0|-4.66|-1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.58|-4.66|<0.0001
71139719|NCT03192176|141778518|SUPERIORITY||LSMean difference|-3.6|STANDARD_ERROR_OF_MEAN|0.78|<|1e-05|TWO_SIDED|95.0|-5.1|-2.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-2.02|-5.10|<0.00001
71139720|NCT03192176|141778518|SUPERIORITY||LSMean difference|-4.2|STANDARD_ERROR_OF_MEAN|0.79|<|0.0001|TWO_SIDED|95.0|-5.78|-2.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-2.66|-5.78|<0.0001
70864973|NCT01967342|141215928|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.643|STANDARD_ERROR_OF_MEAN|0.241|<|0.001|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within CBT for Pain group between the pre-treatment and 10-week post-treatment.||||<.001
70864974|NCT01967342|141215928|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.548|STANDARD_ERROR_OF_MEAN|0.237||0.021|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within CBT for Pain group between the post-treatment and 6-month follow-up.||||.021
70864975|NCT01967342|141215928|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.999|STANDARD_ERROR_OF_MEAN|0.244|<|0.001|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within Pain Ed group between the pre-treatment and 10-week post-treatment.||||< .001
70864976|NCT01967342|141215928|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25|STANDARD_ERROR_OF_MEAN|0.243||0.305|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within Pain Ed group between the post-treatment and 6-month follow-up.||||.305
70864977|NCT01967342|141215929|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.086|STANDARD_ERROR_OF_MEAN|0.623||0.082|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within Usual Care group between the pre-treatment and 10-week post-treatment.||||.082
70864978|NCT01967342|141215929|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.532||0.652|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within Usual Care group between the post-treatment and 6-month follow-up.||||.652
70864979|NCT01967342|141215929|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.416|STANDARD_ERROR_OF_MEAN|0.612|<|0.001|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within CBT for Pain group between the pre-treatment and 10-week post-treatment.||||< .001
70864980|NCT01967342|141215929|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.619|STANDARD_ERROR_OF_MEAN|0.528||0.241|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within CBT for Pain group between the post-treatment and 6-month follow-up.||||.241
70864981|NCT01967342|141215929|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.251|STANDARD_ERROR_OF_MEAN|0.617|<|0.001|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within Pain Ed group between the pre-treatment and 10-week post-treatment.||||< .001
70864982|NCT01967342|141215929|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.434|STANDARD_ERROR_OF_MEAN|0.541||0.422|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within Pain Ed group between the post-treatment and 6-month follow-up.||||.422
70864983|NCT01967342|141215930|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.45|||<|0.001|TWO_SIDED||||||Mixed Models Analysis||CBT vs. TAU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at post-treatment (6-months).||||<.001
70864984|NCT01967342|141215930|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.53||||0.001|TWO_SIDED||||||Mixed Models Analysis||EDU vs. TAU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at post-treatment (10-weeks).||||.001
70864985|NCT01967342|141215930|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.217|TWO_SIDED||||||Mixed Models Analysis||CBT vs. EDU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at pre-treatment (10-weeks).||||.217
70864986|NCT01967342|141215930|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.81||||0.009|TWO_SIDED||||||Mixed Models Analysis||CBT vs. TAU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at follow-up (6-months).||||.009
70864987|NCT01967342|141215930|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.32||||0.001|TWO_SIDED||||||Mixed Models Analysis||EDU vs. TAU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at follow-up (6-months).||||.001
70864988|NCT01967342|141215930|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.389|TWO_SIDED||||||Mixed Models Analysis||CBT vs. EDU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at follow-up (6-months).||||.389
70864989|NCT03789214|141215936|OTHER|One-way ANOVA||||||0.95|||||||ANOVA|||||||.950
70864990|NCT03789214|141215937|OTHER|One-way ANOVA||||||0.048|||||||ANOVA|||||||.048
70948458|NCT02980523|141397973|NON_INFERIORITY|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.341|||||||Chi-squared, Corrected|||||||0.341
70948459|NCT02980523|141397974|NON_INFERIORITY|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.001|||||||Chi-squared, Corrected|||||||0.001
70864991|NCT03789214|141215938|OTHER|One-way ANOVA||||||0.691|||||||ANOVA|||||||.691
70864992|NCT03789214|141215939|OTHER|One-way ANOVA||||||0.62|||||||ANOVA|||||||.620
70864993|NCT03789214|141215940|OTHER|One-way ANOVA||||||0.067|||||||ANOVA|||||||.067
70948460|NCT02980523|141397975|NON_INFERIORITY|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.003|||||||Chi-squared, Corrected|||||||0.003
70948461|NCT02980523|141397976|NON_INFERIORITY|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.216|||||||Chi-squared, Corrected|||||||0.216
70948462|NCT02980523|141397977|NON_INFERIORITY|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.829|||||||Chi-squared, Corrected|||||||0.829
70948463|NCT02229227|141398009|NON_INFERIORITY|If the upper bound of the confidence interval is less than or equal to 0.3%, non-inferiority will be concluded.|Mean Difference (Net)|0.06|||<|0.0001|TWO_SIDED|95.0|-0.05|0.17||Non-inferiority p-value. P-value from testing the null hypothesis that the difference in change from baseline least squares means (albiglutide-insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance.|t-test, 2 sided||Least Square mean of albiglutide + insulin glargine from insulin lispro + insulin glargine has been presented.|||0.17|-0.05|<0.0001
70948464|NCT02229227|141398011|OTHER||Odds Ratio (OR)|0.43|||<|0.0001|TWO_SIDED|95.0|0.31|0.6||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for Baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||0.60|0.31|<0.0001
70948465|NCT02229227|141398012|SUPERIORITY||Mean Difference (Net)|-4.37|||<|0.0001|TWO_SIDED|95.0|-4.93|-3.82|||t-test, 2 sided||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||-3.82|-4.93|<0.0001
70948466|NCT02229227|141398013|OTHER||Mean Difference (Net)|-1.21|||||TWO_SIDED|95.0|-1.43|-1.0|||||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 4 has been presented.|Week 4||-1.00|-1.43|
70948467|NCT02229227|141398013|OTHER||Mean Difference (Net)|-1.8|||||TWO_SIDED|95.0|-2.05|-1.55|||||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 5 has been presented.|Week 5||-1.55|-2.05|
70948468|NCT02229227|141398013|OTHER||Mean Difference (Net)|-3.17|||||TWO_SIDED|95.0|-3.51|-2.82|||||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 10 has been presented.|Week 10||-2.82|-3.51|
70948469|NCT02229227|141398013|OTHER||Mean Difference (Net)|-4.01|||||TWO_SIDED|95.0|-4.48|-3.54|||||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 18 has been presented.|Week 18||-3.54|-4.48|
70948470|NCT02229227|141398013|OTHER||Mean Difference (Net)|-4.37|||<|0.0001|TWO_SIDED|95.0|-4.93|-3.82|||t-test, 2 sided||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 26 has been presented.|Week 26||-3.82|-4.93|<0.0001
70864994|NCT02633501|141215977|SUPERIORITY||Least Squares Mean|-10.59|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|||||Testing procedure stopped|Mixed Models Analysis|||Holm's Step-Down Method||||
70864995|NCT02633501|141215977|SUPERIORITY||Least Squares Mean|2.18|STANDARD_ERROR_OF_MEAN|2.42||0.1858|TWO_SIDED|||||Superiority not confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||0.1858
70864996|NCT02633501|141215977|SUPERIORITY||Least Squares Mean|8.66|STANDARD_ERROR_OF_MEAN|2.55||0.0007|TWO_SIDED|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||0.0007
70948471|NCT02229227|141398014|SUPERIORITY||Mean Difference (Final Values)|-60.83|||<|0.0001|TWO_SIDED|95.0|-66.57|-55.1|||t-test, 2 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||-55.10|-66.57|<0.0001
70948472|NCT02229227|141398015|NON_INFERIORITY|Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance|Mean Difference (Net)|-0.12|||<|0.0001|TWO_SIDED|95.0|-0.18|-0.07|||t-test, 1 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4||-0.07|-0.18|<0.0001
70948473|NCT02229227|141398015|NON_INFERIORITY|Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance|Mean Difference (Net)|-0.09|||<|0.0001|TWO_SIDED|95.0|-0.15|-0.02|||t-test, 1 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 5.|Week 5||-0.02|-0.15|<0.0001
70948474|NCT02229227|141398015|NON_INFERIORITY|Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance|Mean Difference (Net)|0.08|||<|0.0001|TWO_SIDED|95.0|-0.01|0.17|||t-test, 1 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10||0.17|-0.01|<0.0001
70948475|NCT02229227|141398015|NON_INFERIORITY|Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance|Mean Difference (Net)|0.11|||<|0.0001|TWO_SIDED|95.0|0.01|0.21|||t-test, 1 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||0.21|0.01|<0.0001
70864997|NCT02633501|141215977|SUPERIORITY||Least Squares Mean|14.45|STANDARD_ERROR_OF_MEAN|3.37|<|0.0001|TWO_SIDED|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||<0.0001
71139721|NCT03192176|141778518|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.79||0.1318|TWO_SIDED|95.0|-2.76|0.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||0.36|-2.76|0.1318
71139722|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.78||0.001|TWO_SIDED|95.0|-4.13|-1.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.05|-4.13|0.0010
71139723|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.78||0.0011|TWO_SIDED|95.0|-4.1|-1.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.04|-4.10|0.0011
71139724|NCT03192176|141778518|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.79||0.0405|TWO_SIDED|95.0|-3.2|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.07|-3.20|0.0405
71139725|NCT03192176|141778518|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.8||0.0001|TWO_SIDED|95.0|-4.7|-1.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-1.55|-4.70|0.0001
71139726|NCT03192176|141778518|SUPERIORITY||LSMean differencce|-3.1|STANDARD_ERROR_OF_MEAN|0.8||0.0001|TWO_SIDED|95.0|-4.66|-1.52||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-1.52|-4.66|0.0001
70864998|NCT02633501|141215977|SUPERIORITY||Least Squares Mean|-14.14|STANDARD_ERROR_OF_MEAN|4.55|||TWO_SIDED|||||Testing procedure stopped|Mixed Models Analysis|||Holm's Step-Down Method||||
71139727|NCT03192176|141778518|SUPERIORITY||LSMean difference|-3.7|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-5.26|-2.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-2.07|-5.26|<0.0001
71139728|NCT03192176|141778518|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.81||0.0325|TWO_SIDED|95.0|-3.34|-0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.15|-3.34|0.0325
71139729|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.8||0.0035|TWO_SIDED|95.0|-3.92|-0.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.78|-3.92|0.0035
71139730|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.79||0.0102|TWO_SIDED|95.0|-3.61|-0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.49|-3.61|0.0102
71139731|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.81||0.0098|TWO_SIDED|95.0|-3.69|-0.51||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.51|-3.69|0.0098
71139732|NCT03192176|141778518|SUPERIORITY||LSMean difference|-3.6|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-5.18|-1.98||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.98|-5.18|<0.0001
71139733|NCT03192176|141778518|SUPERIORITY||LSMean difference|-3.3|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-4.89|-1.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.70|-4.89|<0.0001
71139734|NCT03192176|141778518|SUPERIORITY||LSMean difference|-4.0|STANDARD_ERROR_OF_MEAN|0.82|<|0.0001|TWO_SIDED|95.0|-5.61|-2.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-2.37|-5.61|<0.0001
71139735|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.82||0.0021|TWO_SIDED|95.0|-4.17|-0.93||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.93|-4.17|0.0021
71139736|NCT03192176|141778518|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.81||0.0001|TWO_SIDED|95.0|-4.71|-1.52||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.52|-4.71|0.0001
70864999|NCT02633501|141215977|SUPERIORITY||Least Squares Mean|1.91|STANDARD_ERROR_OF_MEAN|4.56||0.3384|TWO_SIDED|||||Superiority not confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||0.3384
70865000|NCT02633501|141215977|SUPERIORITY||Least Squares Mean|19.38|STANDARD_ERROR_OF_MEAN|3.94|<|0.0001|TWO_SIDED|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||<0.0001
71139737|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.81||0.002|TWO_SIDED|95.0|-4.11|-0.93||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.93|-4.11|0.0020
71139738|NCT03192176|141778518|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.76||0.021|TWO_SIDED|95.0|-3.27|-0.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.27|-3.27|0.0210
71139739|NCT03192176|141778518|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.77|<|0.0001|TWO_SIDED|95.0|-4.59|-1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.58|-4.59|<0.0001
71139740|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.88|STANDARD_ERROR_OF_MEAN|0.77||0.0003|TWO_SIDED|95.0|-4.34|-1.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.33|-4.34|0.0003
71139741|NCT03192176|141778518|SUPERIORITY||LSMean difference|-3.8|STANDARD_ERROR_OF_MEAN|0.73|<|0.0001|TWO_SIDED|95.0|-5.29|-2.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-2.23|-5.29|<0.0001
71139742|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.77||0.0023|TWO_SIDED|95.0|-3.91|-0.86||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.86|-3.91|0.0023
71139743|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.76||0.0004|TWO_SIDED|95.0|-4.25|-1.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.24|-4.25|0.0004
71139744|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.76||0.0036|TWO_SIDED|95.0|-3.73|-0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.74|-3.73|0.0036
70865001|NCT02633501|141215977|SUPERIORITY||Least Squares Mean|38.37|STANDARD_ERROR_OF_MEAN|9.76||0.0002|TWO_SIDED|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||0.0002
70948476|NCT02229227|141398015|NON_INFERIORITY|Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance|Mean Difference (Net)|0.06|||<|0.0001|TWO_SIDED|95.0|-0.05|0.17|||t-test, 1 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|Week 26||0.17|-0.05|<0.0001
70948477|NCT02229227|141398016|SUPERIORITY||Mean Difference (Net)|-0.55||||0.0004|TWO_SIDED|95.0|-0.86|-0.25|||t-test, 2 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||-0.25|-0.86|0.0004
70948478|NCT02229227|141398017|OTHER||Mean Difference (Net)|-0.54|||||TWO_SIDED|95.0|-0.84|-0.24|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4||-0.24|-0.84|
70948479|NCT02229227|141398017|OTHER||Mean Difference (Net)|-0.19|||||TWO_SIDED|95.0|-0.51|0.13|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 5.|Week 5||0.13|-0.51|
71139745|NCT03192176|141778518|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.77||0.0195|TWO_SIDED|95.0|-3.33|-0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.29|-3.33|0.0195
70865002|NCT02633501|141215977|SUPERIORITY||Least Squares Mean|-23.96|STANDARD_ERROR_OF_MEAN|4.88|||TWO_SIDED|||||Testing procedure stopped|Mixed Models Analysis|||Holm's Step-Down Method||||
71139746|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.77||0.0006|TWO_SIDED|95.0|-4.21|-1.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.17|-4.21|0.0006
71139747|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.77||0.0004|TWO_SIDED|95.0|-4.32|-1.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.27|-4.32|0.0004
71139748|NCT03192176|141778518|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|0.79|<|0.0001|TWO_SIDED|95.0|-5.01|-1.92||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.92|-5.01|<0.0001
71139749|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.78||0.0061|TWO_SIDED|95.0|-3.71|-0.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.62|-3.71|0.0061
71139750|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.77||0.0006|TWO_SIDED|95.0|-4.19|-1.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.14|-4.19|0.0006
71139751|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.77||0.003|TWO_SIDED|95.0|-3.81|-0.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.78|-3.81|0.0030
71139752|NCT03192176|141778518|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.78||0.0383|TWO_SIDED|95.0|-3.17|-0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.09|-3.17|0.0383
71139753|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.79||0.0004|TWO_SIDED|95.0|-4.33|-1.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-1.24|-4.33|0.0004
71139754|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.79||0.0011|TWO_SIDED|95.0|-4.14|-1.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-1.04|-4.14|0.0011
71139755|NCT03192176|141778518|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|TWO_SIDED|95.0|-5.07|-1.93||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-1.93|-5.07|<0.0001
70865003|NCT02633501|141215977|SUPERIORITY||Least Squares Mean|2.47|STANDARD_ERROR_OF_MEAN|5.4||0.3249|TWO_SIDED|||||Superiority not confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||0.3249
70948480|NCT02229227|141398017|OTHER||Mean Difference (Net)|-0.53|||||TWO_SIDED|95.0|-0.85|-0.22|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||-0.22|-0.85|
70948481|NCT02229227|141398017|SUPERIORITY||Mean Difference (Net)|-0.55||||0.0004|TWO_SIDED|95.0|-0.86|-0.25|||t-test, 2 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|Week 26||-0.25|-0.86|0.0004
70948482|NCT02229227|141398018|OTHER||Odds Ratio (OR)|0.96||||0.7026|TWO_SIDED|95.0|0.71|1.31||Non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for Baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||1.31|0.71|0.7026
70865004|NCT02633501|141215977|SUPERIORITY||Least Squares Mean|29.23|STANDARD_ERROR_OF_MEAN|6.53|<|0.0001|TWO_SIDED|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||<0.0001
71139756|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.8||0.0055|TWO_SIDED|95.0|-3.8|-0.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.66|-3.80|0.0055
71139757|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.79||0.0014|TWO_SIDED|95.0|-4.09|-0.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.99|-4.09|0.0014
71139758|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.78||0.004|TWO_SIDED|95.0|-3.8|-0.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.73|-3.80|0.0040
71139759|NCT03192176|141778518|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.78||0.1502|TWO_SIDED|95.0|-2.68|0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.41|-2.68|0.1502
71139760|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.79||0.0057|TWO_SIDED|95.0|-3.74|-0.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.64|-3.74|0.0057
71139761|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.79||0.0054|TWO_SIDED|95.0|-3.76|-0.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.66|-3.76|0.0054
71139762|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.8||0.0006|TWO_SIDED|95.0|-4.38|-1.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-1.22|-4.38|0.0006
71139763|NCT03192176|141778518|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.8||0.0412|TWO_SIDED|95.0|-3.21|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.07|-3.21|0.0412
71139764|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.79||0.0054|TWO_SIDED|95.0|-3.76|-0.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.66|-3.76|0.0054
71139765|NCT03192176|141778518|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.78||0.0167|TWO_SIDED|95.0|-3.43|-0.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.34|-3.43|0.0167
71139766|NCT03192176|141778518|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.75||0.0533|TWO_SIDED|95.0|-2.94|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.02|-2.94|0.0533
71139767|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.75||0.0065|TWO_SIDED|95.0|-3.54|-0.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.58|-3.54|0.0065
71139768|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.76||0.0025|TWO_SIDED|95.0|-3.8|-0.82||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.82|-3.80|0.0025
71139769|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.77||0.0005|TWO_SIDED|95.0|-4.22|-1.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.20|-4.22|0.0005
71139770|NCT03192176|141778518|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.77||0.0541|TWO_SIDED|95.0|-2.99|0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.03|-2.99|0.0541
70865005|NCT02633501|141215977|SUPERIORITY||Least Squares Mean|51.96|STANDARD_ERROR_OF_MEAN|10.68|<|0.0001|TWO_SIDED|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||<0.0001
70865006|NCT00395733|141215978|NON_INFERIORITY_OR_EQUIVALENCE|Estimates for investigators only. A non-inferiority margin of 15% was assumed. Based on 60 pairs of observations in a crossover design (15 participants with 10 vessels segments, 15 participants with 6 vessels segments and 30 participants with 17 vessels segments to be visualized and assessed) and non-inferiority testing based the lower limit of Fieller's one-sided 95% confidence interval for the ratio Gadavist / Magnevist of the means, the power was at least 80% under realistic assumptions.|Ratio of means|0.9736||||||90.0|0.9315|1.0168|||Fieller-type confidence interval||For the estimation, only vessel segments with vascular assessments available for both periods were considered. The lower limit of the 95% one-sided Fieller-type confidence interval was compared with the non-inferiority margin 0.85.|Non-inferiority analysis: The aim was to show that Gadavist is not inferior (i.e. similar or better) to Magnevist in visualizing different vascular regions of the body with diagnostic quality in contrast enhanced MRA. Gadavist was to be considered to be non-inferior to Magnevist if the mean number of vessel segments visualized with diagnostic quality of Gadavist enhanced-MRA images was higher than 85% of that of Magnevist enhanced-MRA images in a cross-over design.||1.0168|0.9315|
70865007|NCT00395733|141215978|NON_INFERIORITY_OR_EQUIVALENCE|Estimates for blinded reader 1 only. A non-inferiority margin of 15% was assumed. Based on 60 pairs of observations in a crossover design (15 participants with 10 vessels segments, 15 participants with 6 vessels segments and 30 participants with 17 vessels segments to be visualized and assessed) and non-inferiority testing based the lower limit of Fieller's one-sided 95% confidence interval for the ratio Gadavist / Magnevist of the means, the power was at least 80% under realistic assumptions.|Ratio of means|0.954||||||90.0|0.9122|0.9965|||Fieller-type confidence interval||For the estimation, only vessel segments with vascular assessments available for both periods were considered. The lower limit of the 95% one-sided Fieller-type confidence interval was compared with the non-inferiority margin 0.85.|Non-inferiority analysis: The aim was to show that Gadavist is not inferior (i.e. similar or better) to Magnevist in visualizing different vascular regions of the body with diagnostic quality in contrast enhanced MRA. Gadavist was to be considered to be non-inferior to Magnevist if the mean number of vessel segments visualized with diagnostic quality of Gadavist enhanced-MRA images was higher than 85% of that of Magnevist enhanced-MRA images in a cross-over design.||0.9965|0.9122|
70865008|NCT00395733|141215978|NON_INFERIORITY_OR_EQUIVALENCE|Estimates for blinded reader 2 only. A non-inferiority margin of 15% was assumed. Based on 60 pairs of observations in a crossover design (15 participants with 10 vessels segments, 15 participants with 6 vessels segments and 30 participants with 17 vessels segments to be visualized and assessed) and non-inferiority testing based the lower limit of Fieller's one-sided 95% confidence interval for the ratio Gadavist / Magnevist of the means, the power was at least 80% under realistic assumptions.|Ratio of means|0.9458||||||90.0|0.8776|1.024|||Fieller-type confidence interval||For the estimation, only vessel segments with vascular assessments available for both periods were considered. The lower limit of the 95% one-sided Fieller-type confidence interval was compared with the non-inferiority margin 0.85.|Non-inferiority analysis: The aim was to show that Gadavist is not inferior (i.e. similar or better) to Magnevist in visualizing different vascular regions of the body with diagnostic quality in contrast enhanced MRA. Gadavist was to be considered to be non-inferior to Magnevist if the mean number of vessel segments visualized with diagnostic quality of Gadavist enhanced-MRA images was higher than 85% of that of Magnevist enhanced-MRA images in a cross-over design.||1.0240|0.8776|
70865009|NCT00395733|141215978|NON_INFERIORITY_OR_EQUIVALENCE|Estimates for blinded reader 3 only. A non-inferiority margin of 15% was assumed. Based on 60 pairs of observations in a crossover design (15 participants with 10 vessels segments, 15 participants with 6 vessels segments and 30 participants with 17 vessels segments to be visualized and assessed) and non-inferiority testing based the lower limit of Fieller's one-sided 95% confidence interval for the ratio Gadavist / Magnevist of the means, the power was at least 80% under realistic assumptions.|Ratio of means|0.8698||||||90.0|0.78|0.9657|||Fieller-type confidence interval||For the estimation, only vessel segments with vascular assessments available for both periods were considered. The lower limit of the 95% one-sided Fieller-type confidence interval was compared with the non-inferiority margin 0.85.|Non-inferiority analysis: The aim was to show that Gadavist is not inferior (i.e. similar or better) to Magnevist in visualizing different vascular regions of the body with diagnostic quality in contrast enhanced MRA. Gadavist was to be considered to be non-inferior to Magnevist if the mean number of vessel segments visualized with diagnostic quality of Gadavist enhanced-MRA images was higher than 85% of that of Magnevist enhanced-MRA images in a cross-over design.||0.9657|0.7800|
70872202|NCT01727297|141229672|SUPERIORITY||Hazard Ratio (HR)|1.08|||<|0.001|TWO_SIDED|95.0|1.05|1.11||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons. Age was treated as a continuous variable in years.|Regression, Cox||The hazard ratio represented the effect of a one year increase in age on a patient's risk of developing AF. Descriptive statistics (mean±standard deviation) for age were 75.7±7.9 years among patients with AF, and 69.4±10.0 among patients without AF|The null hypothesis was that age did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.11|1.05|< 0.001
70948483|NCT02229227|141398019|OTHER||Odds Ratio (OR)|1.17||||0.2883|TWO_SIDED|95.0|0.84|1.64||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4|Week 4||1.64|0.84|0.2883
70948484|NCT02229227|141398019|OTHER||Odds Ratio (OR)|0.82||||0.3034|TWO_SIDED|95.0|0.59|1.15||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 5.|Week 5||1.15|0.59|0.3034
70948485|NCT02229227|141398019|OTHER||Odds Ratio (OR)|0.71||||0.0151|TWO_SIDED|95.0|0.52|0.98||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10||0.98|0.52|0.0151
70865010|NCT01044706|141215989|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference produts. Differences were declared statistically significant at the 5% level (p\<0.05).|ratio of T/R geometric mean x 100|108.46|STANDARD_ERROR_OF_MEAN|0.0321|<|0.05|TWO_SIDED|90.0|102.79|114.44||Differences were declared statistically significant at the 5% level (p\<0.05).|ANOVA|degrees of freedom 55|Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean for AUCO-144 and Cmax between the test and reference product fall within the interval of 80-125%.|Using GLM procedures in SAS, ANOVA was performed on ln-transformed AUC0-144 at the alpha level of 0.05. Factors incorporated in the model will include: Group, Treatment and Treatment\*Group. Intra-subject coefficient of variation (CV%) will be estimated. The ratio of means (T/R) and 90% geometric confidence interval for the ratio of means, based on least-squares means from the ANOVA of the ln-transformed data, will be calculated for AUC0-144 hour.||114.44|102.79|<0.05
70948486|NCT02229227|141398019|OTHER||Odds Ratio (OR)|0.75||||0.0518|TWO_SIDED|95.0|0.54|1.03||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||1.03|0.54|0.0518
70948487|NCT02229227|141398019|OTHER||Odds Ratio (OR)|0.96||||0.7026|TWO_SIDED|95.0|0.71|1.31||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|Week 26||1.31|0.71|0.7026
70948488|NCT02229227|141398020|OTHER||Odds Ratio (OR)|0.85||||0.2298|TWO_SIDED|95.0|0.63|1.17||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||1.17|0.63|0.2298
70948489|NCT02229227|141398021|OTHER||Odds Ratio (OR)|1.32||||0.2143|TWO_SIDED|95.0|0.78|2.23||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4||2.23|0.78|0.2143
70948490|NCT02229227|141398021|OTHER||Odds Ratio (OR)|1.24||||0.4703|TWO_SIDED|95.0|0.8|1.91||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 5.|Week 5||1.91|0.80|0.4703
70948491|NCT02229227|141398021|OTHER||Odds Ratio (OR)|0.81||||0.2139|TWO_SIDED|95.0|0.58|1.14||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10||1.14|0.58|0.2139
70948492|NCT02229227|141398021|OTHER||Odds Ratio (OR)|0.81||||0.079|TWO_SIDED|95.0|0.59|1.11||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||1.11|0.59|0.0790
70948493|NCT02229227|141398021|OTHER||Odds Ratio (OR)|0.85||||0.2298|TWO_SIDED|95.0|0.63|1.17||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|Week 26||1.17|0.63|0.2298
70948494|NCT02229227|141398022|OTHER||Odds Ratio (OR)|1.08||||0.8292|TWO_SIDED|95.0|0.24|4.77||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||4.77|0.24|0.8292
70948495|NCT02229227|141398024|OTHER||Mean Difference (Final Values)|-56.38|||||TWO_SIDED|95.0|-59.19|-53.57|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4||-53.57|-59.19|
70948496|NCT02229227|141398024|OTHER||Mean Difference (Final Values)|-63.7|||||TWO_SIDED|95.0|-67.78|-59.62|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10||-59.62|-67.78|
70948497|NCT02229227|141398024|OTHER||Mean Difference (Final Values)|-62.0|||||TWO_SIDED|95.0|-67.29|-56.7|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||-56.70|-67.29|
70948498|NCT02229227|141398025|SUPERIORITY||Mean Difference (Final Values)|-0.97|||||TWO_SIDED|95.0|-2.25|0.3|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4||0.30|-2.25|
70948499|NCT02229227|141398025|OTHER||Mean Difference (Final Values)|0.34|||||TWO_SIDED|95.0|-1.64|2.33|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10||2.33|-1.64|
70948500|NCT02229227|141398025|OTHER||Mean Difference (Final Values)|0.24|||||TWO_SIDED|95.0|-2.21|2.69|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||2.69|-2.21|
70948501|NCT02229227|141398025|OTHER||Mean Difference (Final Values)|0.39||||0.7699|TWO_SIDED|95.0|-2.25|3.04|||t-test, 2 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|Week 26||3.04|-2.25|0.7699
70865011|NCT01044706|141215990|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference produts. Differences were declared statistically significant at the 5% level (p\<0.05).|ratio of T/R geometric mean x 100|110.5|STANDARD_ERROR_OF_MEAN|0.0281|<|0.05|TWO_SIDED|95.0|105.43|115.82||Differences were declared statistically significant at the 5% level (p\<0.05).|ANOVA|degrees of freedom 56|Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean for AUCO-144 and Cmax between the test and reference product fall within the interval of 80-125%.|Using GLM procedures in SAS, ANOVA was performed on ln-transformed Cmax at the alpha level of 0.05. Factors incorporated in the model will include: Group, Treatment and Treatment\*Group. Intra-subject coefficient of variation (CV%) will be estimated. The ratio of means (T/R) and 90% geometric confidence interval for the ratio of means, based on least-squares means from the ANOVA of the ln-transformed data, will be calculated for Cmax.||115.82|105.43|<0.05
70865012|NCT02913612|141216000|SUPERIORITY||Odds Ratio, log|2.65||||0.0205|TWO_SIDED|95.0|1.12|6.26|||Fisher Exact|||||6.26|1.12|0.0205
70865013|NCT02913612|141216000|SUPERIORITY||Odds Ratio, log|2.16||||0.0619|TWO_SIDED|95.0|0.91|5.14|||Fisher Exact|||||5.14|0.91|0.0619
70948502|NCT02229227|141398026|OTHER||Mean Difference (Final Values)|-56.05|||||TWO_SIDED|95.0|-58.17|-53.94|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4||-53.94|-58.17|
71139771|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.76||0.0039|TWO_SIDED|95.0|-3.69|-0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.71|-3.69|0.0039
71139772|NCT03192176|141778518|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.75||0.0245|TWO_SIDED|95.0|-3.18|-0.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.22|-3.18|0.0245
70865014|NCT02913612|141216000|SUPERIORITY||Odds Ratio, log|1.23||||0.6281|TWO_SIDED|95.0|0.53|2.82|||Fisher Exact|||||2.82|0.53|0.6281
70865015|NCT03452228|141216013|SUPERIORITY||Median Difference (Final Values)|-43.5|||||TWO_SIDED|95.0|-89.4|1238.9||||||||1238.9|-89.4|
70865016|NCT03452228|141216013|SUPERIORITY||Median Difference (Final Values)|-75.5|||||TWO_SIDED|95.0|-82.2|121.2||||||||121.2|-82.2|
70865017|NCT02955797|141216029|NON_INFERIORITY|95% confidence interval (CI) was stratified on the priming status (meningococcal vaccine naïve or primed monovalent MenC vaccination during infancy) and calculated using the Wald method (normal approximation). Weighted average of the difference over strata was calculated using the Minimal Risk weights with the null variance method. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was greater than (\>) -10%.|Percentage difference|-2.03|||||TWO_SIDED|95.0|-5.84|1.78||||||Serogroup A||1.78|-5.84|
70865018|NCT02955797|141216029|NON_INFERIORITY|95% CI was stratified on the priming status (meningococcal vaccine naïve or primed monovalent MenC vaccination during infancy) and calculated using the Wald method (normal approximation). Weighted average of the difference over strata was calculated using the Minimal Risk weights with the null variance method. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|12.1|||||TWO_SIDED|95.0|8.16|16.1||||||Serogroup C||16.1|8.16|
70948503|NCT02229227|141398026|OTHER||Mean Difference (Final Values)|-64.76|||||TWO_SIDED|95.0|-67.68|-61.85|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10||-61.85|-67.68|
71139773|NCT03192176|141778518|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.78||0.0187|TWO_SIDED|95.0|-3.36|-0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.31|-3.36|0.0187
70865019|NCT02955797|141216029|NON_INFERIORITY|95% CI was stratified on the priming status (meningococcal vaccine naïve or primed monovalent MenC vaccination during infancy) and calculated using the Wald method (normal approximation). Weighted average of the difference over strata was calculated using the Minimal Risk weights with the null variance method. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|2.42|||||TWO_SIDED|95.0|-1.34|6.19||||||Serogroup Y||6.19|-1.34|
70865020|NCT02955797|141216029|NON_INFERIORITY|95% CI was stratified on the priming status (meningococcal vaccine naïve or primed monovalent MenC vaccination during infancy) and calculated using the Wald method (normal approximation). Weighted average of the difference over strata was calculated using the Minimal Risk weights with the null variance method. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|0.458|||||TWO_SIDED|95.0|-4.37|5.28||||||Serogroup W||5.28|-4.37|
71139774|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.78||0.006|TWO_SIDED|95.0|-3.68|-0.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.62|-3.68|0.0060
71139775|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.78||0.0014|TWO_SIDED|95.0|-4.06|-0.98||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.98|-4.06|0.0014
71139776|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|0.79||0.0003|TWO_SIDED|95.0|-4.49|-1.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-1.37|-4.49|0.0003
71139777|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.79||0.01|TWO_SIDED|95.0|-3.61|-0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.49|-3.61|0.0100
71139778|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.78||0.0019|TWO_SIDED|95.0|-3.98|-0.91||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.91|-3.98|0.0019
70865021|NCT02955797|141216030|NON_INFERIORITY|95% CI of the difference in percentages was computed using the Wilson Score method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|1.3|||||TWO_SIDED|95.0|-3.6|6.2||||||Serogroup A||6.2|-3.6|
70948504|NCT02229227|141398026|OTHER||Mean Difference (Final Values)|-62.92|||||TWO_SIDED|95.0|-66.69|-59.15|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||-59.15|-66.69|
71139779|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.78||0.0049|TWO_SIDED|95.0|-3.73|-0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.67|-3.73|0.0049
71139780|NCT03192176|141778518|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.75||0.0186|TWO_SIDED|95.0|-3.25|-0.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.30|-3.25|0.0186
71139781|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.75||0.0024|TWO_SIDED|95.0|-3.77|-0.82||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.82|-3.77|0.0024
71139782|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.76||0.0003|TWO_SIDED|95.0|-4.28|-1.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.30|-4.28|0.0003
71139783|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.77||0.0003|TWO_SIDED|95.0|-4.3|-1.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.29|-4.30|0.0003
71139784|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.76||0.0058|TWO_SIDED|95.0|-3.63|-0.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.62|-3.63|0.0058
71139785|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.75||0.0008|TWO_SIDED|95.0|-4.04|-1.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.7|-4.04|0.0008
70865022|NCT02955797|141216030|NON_INFERIORITY|95% CI of the difference in percentages was computed using the Wilson Score method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|18.0|||||TWO_SIDED|95.0|13.6|22.8||||||Serogroup C||22.8|13.6|
70865023|NCT02955797|141216030|NON_INFERIORITY|95% CI of the difference in percentages was computed using the Wilson Score method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|1.6|||||TWO_SIDED|95.0|-2.76|6.03||||||Serogroup Y||6.03|-2.76|
70865024|NCT02955797|141216030|NON_INFERIORITY|95% CI of the difference in percentages was computed using the Wilson Score method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|0.2|||||TWO_SIDED|95.0|-5.85|6.18||||||Serogroup W||6.18|-5.85|
70865025|NCT02955797|141216031|OTHER|95% CI of the ratio of post-vaccination GMTs was stratified on the priming vaccination status (meningococcal vaccine naïve or primed monovalent MenC vaccination) and calculated using an analysis of variance (ANOVA) model of log10-transformed titers.|GMT Ratio|0.819|||||TWO_SIDED|95.0|0.697|0.963||||||Serogroup A||0.963|0.697|
70865026|NCT02955797|141216031|OTHER|95% CI of the ratio of post-vaccination GMTs was stratified on the priming vaccination status (meningococcal vaccine naïve or primed monovalent MenC vaccination) and calculated using an ANOVA model of log10-transformed titers.|GMT Ratio|7.59|||||TWO_SIDED|95.0|6.05|9.52||||||Serogroup C||9.52|6.05|
70865027|NCT02955797|141216031|OTHER|95% CI of the ratio of post-vaccination GMTs was stratified on the priming vaccination status (meningococcal vaccine naïve or primed monovalent MenC vaccination) and calculated using an ANOVA model of log10-transformed titers.|GMT Ratio|1.28|||||TWO_SIDED|95.0|1.09|1.51||||||Serogroup Y||1.51|1.09|
70865028|NCT02955797|141216031|OTHER|95% CI of the ratio of post-vaccination GMTs was stratified on the priming vaccination status (meningococcal vaccine naïve or primed monovalent MenC vaccination) and calculated using an ANOVA model of log10-transformed titers.|GMT Ratio|1.32|||||TWO_SIDED|95.0|1.12|1.56||||||Serogroup W||1.56|1.12|
70865029|NCT02955797|141216032|OTHER||GMT Ratio|1.03|||||TWO_SIDED|95.0|0.85|1.24||||||Serogroup A||1.24|0.85|
70865030|NCT02955797|141216032|OTHER||GMT Ratio|16.5|||||TWO_SIDED|95.0|13.4|20.4||||||Serogroup C||20.4|13.4|
70865031|NCT02955797|141216032|OTHER||GMT Ratio|1.18|||||TWO_SIDED|95.0|0.97|1.44||||||Serogroup Y||1.44|0.97|
70865032|NCT02955797|141216032|OTHER||GMT Ratio|1.34|||||TWO_SIDED|95.0|1.1|1.63||||||Serogroup W||1.63|1.1|
70865033|NCT02955797|141216033|OTHER||GMT Ratio|0.496|||||TWO_SIDED|95.0|0.367|0.672||||||Serogroup A||0.672|0.367|
70865034|NCT02955797|141216033|OTHER||GMT Ratio|1.34|||||TWO_SIDED|95.0|0.814|2.19||||||Serogroup C||2.19|0.814|
70865035|NCT02955797|141216033|OTHER||GMT Ratio|1.53|||||TWO_SIDED|95.0|1.15|2.04||||||Serogroup Y||2.04|1.15|
70865036|NCT02955797|141216033|OTHER||GMT Ratio|1.29|||||TWO_SIDED|95.0|0.944|1.75||||||Serogroup W||1.75|0.944|
70865037|NCT02128932|141216110|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 1.0 mg and insulin glargine was below the pre-specified non-inferiority margin (0.3 %).|Treatment difference|-0.81|||<|0.0001|TWO_SIDED|95.0|-0.96|-0.67|||Mixed Models Analysis|||The post baseline responses were analysed using a mixed model for repeated measurements with treatment , country and stratum as fixed factors and baseline value as covariate, all nested within visit.||-0.67|-0.96|<0.0001
70865038|NCT02128932|141216110|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper limit of the two-sided 95 % confidence interval for the estimated treatment difference between semaglutide 0.5 mg and insulin glargine was below the pre-specified non-inferiority margin (0.3%).|Treatment difference|-0.38|||<|0.0001|TWO_SIDED|95.0|-0.52|-0.24|||Mixed Models Analysis|||The post baseline responses were analysed using a mixed model for repeated meausrements with treatment, country and stratum value as covariate, all nested within visit.||-0.24|-0.52|<0.0001
70865039|NCT00657358|141216119|SUPERIORITY_OR_OTHER||R^2 (adj)|0.477|||<|0.001|TWO_SIDED|95.0|||||Regression, Linear|DF=2 DFDEN=371.8, F-ratio=10.66||||||<0.001
70865040|NCT02728596|141216124|SUPERIORITY||Odds Ratio (OR)|0.44||||0.21|TWO_SIDED|95.0|0.12|1.57|||Regression, Logistic|Adjusted for age group, comorbidity, race, and Hispanic ethnicity.||PP-CSF use in the high risk FN group was compared between the usual care (UC) group (Arm 2) and the intervention group (Arm 3 and 4 combined).||1.57|0.12|0.21
70865041|NCT02728596|141216124|SUPERIORITY||Odds Ratio (OR)|1.18||||0.74|TWO_SIDED|95.0|0.44|3.2|||Regression, Logistic|Adjusted for age, sex, and cancer type.||PP-CSF use in the low risk FN group was compared between the usual care (UC) group (Arm 2) and the intervention group (Arm 3 and 4 combined).||3.20|0.44|0.74
70865042|NCT02728596|141216124|SUPERIORITY||Odds Ratio (OR)|2.23||||0.17|TWO_SIDED|95.0|0.7|7.08|||Regression, Logistic|Adjusted for age, sex, and cancer type.||PP-CSF use in the intermediate risk FN group was compared between the usual care (UC) group (Arm 2) and the SOE for PP-CSF intervention group (Arm 3).||7.08|0.70|0.17
70865043|NCT02728596|141216124|SUPERIORITY||Odds Ratio (OR)|0.36||||0.094|TWO_SIDED|95.0|0.11|1.19|||Regression, Logistic|Adjusted for age, sex, and cancer type.||PP-CSF use in the intermediate risk FN group was compared between the usual care (UC) group (Arm 2) and the alert against PP-CSF intervention group (Arm 4).||1.19|0.11|0.094
70865044|NCT02728596|141216125|SUPERIORITY||Odds Ratio (OR)|1.49||||0.26|TWO_SIDED|95.0|0.75|2.95|||Regression, Logistic|Adjusted for age.||FN incidence rate in the high risk FN group was compared between the usual care (UC) group (Arm 2) and the intervention group (Arm 3 and 4 combined).||2.95|0.75|0.26
70865045|NCT02728596|141216125|SUPERIORITY||Odds Ratio (OR)|2.0||||0.51|TWO_SIDED|95.0|0.23|18.8|||Regression, Logistic|Adjusted for cancer type.||FN incidence rate in the low risk FN group was compared between the usual care (UC) group (Arm 2) and the intervention group (Arm 3 and 4 combined).||18.80|0.23|0.51
70865046|NCT02728596|141216125|SUPERIORITY||Odds Ratio (OR)|1.09||||0.87|TWO_SIDED|95.0|0.41|2.88|||Regression, Logistic|||FN incidence rate in the intermediate risk FN group was compared between the usual care (UC) group (Arm 2) and the SOE for PP-CSF intervention group (Arm 3).||2.88|0.41|0.87
70865047|NCT02728596|141216125|SUPERIORITY||Odds Ratio (OR)|1.25||||0.68|TWO_SIDED|95.0|0.44|3.57|||Regression, Logistic|||FN incidence rate in the intermediate risk FN group was compared between the usual care (UC) group (Arm 2) and the alert against PP-CSF intervention group (Arm 4).||3.57|0.44|0.68
70948505|NCT02229227|141398026|SUPERIORITY||Mean Difference (Final Values)|-61.83|||<|0.0001|TWO_SIDED|95.0|-65.85|-57.81|||t-test, 2 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|week 26||-57.81|-65.85|<0.0001
70948506|NCT02229227|141398028|OTHER||Odds Ratio (OR)|3.5|||<|0.0001|TWO_SIDED|95.0|2.52|4.86||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||4.86|2.52|<0.0001
70948507|NCT02229227|141398029|OTHER||Odds Ratio (OR)|2.36|||<|0.0001|TWO_SIDED|95.0|1.54|3.6||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||3.60|1.54|<0.0001
70948508|NCT02229227|141398030|OTHER||Odds Ratio (OR)|3.78|||<|0.0001|TWO_SIDED|95.0|2.21|6.48||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||6.48|2.21|<0.0001
70865048|NCT02728596|141216126|SUPERIORITY||Odds Ratio (OR)|0.87||||0.74|TWO_SIDED|95.0|0.39|1.95|||Regression, Logistic|Adjusted for cancer type.||||1.95|0.39|0.74
70865049|NCT02728596|141216126|SUPERIORITY||Odds Ratio (OR)|1.09||||0.87|TWO_SIDED|95.0|0.41|2.88|||Regression, Logistic|Adjusted for cancer type.||||2.88|0.41|0.87
70865050|NCT02728596|141216126|SUPERIORITY||Odds Ratio (OR)|1.25||||0.68|TWO_SIDED|95.0|0.44|3.57|||Regression, Logistic|Adjusted for cancer type.||This is comparing the FN incidence rate in the arm randomized to alert against PP-CSF vs usual care in intermediate risk participants.||3.57|0.44|0.68
70865051|NCT03221270|141216138|SUPERIORITY|alternative hypothesis: true difference in means is greater than 0|Median Difference (Final Values)|-0.43||||0.66|ONE_SIDED|95.0|-2.25||||t-test, 1 sided||||||-2.25|0.66
71139786|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.75||0.005|TWO_SIDED|95.0|-3.59|-0.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.64|-3.59|0.0050
71139787|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.85||0.0205|TWO_SIDED|95.0|-3.63|-0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.31|-3.63|0.0205
71139788|NCT03192176|141778518|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.85||0.2818|TWO_SIDED|95.0|-2.58|0.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMMRM|||Week 13||0.75|-2.58|0.2818
71139789|NCT03192176|141778518|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.87||0.3102|TWO_SIDED|95.0|-2.6|0.83||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.83|-2.60|0.3102
71139790|NCT03192176|141778518|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.87||0.1422|TWO_SIDED|95.0|-2.99|0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|LSMean difference|||Week 13||0.43|-2.99|0.1422
71139791|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.87||0.0064|TWO_SIDED|95.0|-4.12|-0.68||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.68|-4.12|0.0064
71139792|NCT03192176|141778518|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.87||0.0752|TWO_SIDED|95.0|-3.28|0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.16|-3.28|0.0752
71139793|NCT03192176|141778518|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.85||0.3632|TWO_SIDED|95.0|-2.43|0.89||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.89|-2.43|0.3632
71139794|NCT03192176|141778518|SUPERIORITY||LSMean differencce|-1.6|STANDARD_ERROR_OF_MEAN|0.87||0.0625|TWO_SIDED|95.0|-3.32|0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.09|-3.32|0.0625
71139795|NCT03192176|141778518|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.86||0.6613|TWO_SIDED|95.0|-2.07|1.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.32|-2.07|0.6613
70865052|NCT05736224|141216168|SUPERIORITY|||||||0.003||||||No sunscreen compared to test sunscreen|t-test, 2 sided|||||||0.003
70865053|NCT04806503|141216185|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.006|STANDARD_ERROR_OF_MEAN|0.0258||0.817|TWO_SIDED|95.0|-0.045|0.056|||Mixed-effect Model for Repeated Measures|||||0.056|-0.045|0.817
71139796|NCT03192176|141778518|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.9||0.4209|TWO_SIDED|95.0|-2.48|1.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.04|-2.48|0.4209
71139797|NCT03192176|141778518|SUPERIORITY||LSMean differencce|-0.9|STANDARD_ERROR_OF_MEAN|0.89||0.3288|TWO_SIDED|95.0|-2.63|0.88||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.88|-2.63|0.3288
71139798|NCT03192176|141778518|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.9||0.0202|TWO_SIDED|95.0|-3.86|-0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.33|-3.86|0.0202
71139799|NCT03192176|141778518|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.9||0.0682|TWO_SIDED|95.0|-3.42|0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.12|-3.42|0.0682
71139800|NCT03192176|141778518|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.86||0.3912|TWO_SIDED|95.0|-2.44|0.96||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.96|-2.44|0.3912
71139801|NCT03192176|141778518|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.85||0.4964|TWO_SIDED|95.0|-2.25|1.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.09|-2.25|0.4964
71139802|NCT03192176|141778518|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.84||0.983|TWO_SIDED|95.0|-1.64|1.68||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.68|-1.64|0.9830
71139803|NCT03192176|141778518|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.89||0.9715|TWO_SIDED|95.0|-1.71|1.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.78|-1.71|0.9715
71139804|NCT03192176|141778518|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.87||0.8715|TWO_SIDED|95.0|-1.58|1.86||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.86|-1.58|0.8715
71139805|NCT03192176|141778518|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.89||0.2233|TWO_SIDED|95.0|-2.83|0.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.66|-2.83|0.2233
71139806|NCT03192176|141778518|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.89||0.2882|TWO_SIDED|95.0|-2.69|0.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.80|-2.69|0.2882
71139807|NCT03192176|141778518|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.84||0.8643||95.0|-1.52|1.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.80|-1.52|0.8643
70865054|NCT04806503|141216185|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.002|STANDARD_ERROR_OF_MEAN|0.0262||0.946|TWO_SIDED|95.0|-0.05|0.053|||Mixed-effect Model for Repeated Measures|||||0.053|-0.050|0.946
70865055|NCT04806503|141216185|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|-0.024|STANDARD_ERROR_OF_MEAN|0.027||0.38|TWO_SIDED|95.0|-0.077|0.029|||Mixed-effect Model for Repeated Measures|||||0.029|-0.077|0.380
70865056|NCT04806503|141216185|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.011|STANDARD_ERROR_OF_MEAN|0.0258||0.667|TWO_SIDED|95.0|-0.039|0.062|||Mixed-effect Model for Repeated Measures|||||0.062|-0.039|0.667
71139808|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0104|TWO_SIDED|95.0|-0.53|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.07|-0.53|0.0104
71139809|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.006|TWO_SIDED|95.0|-0.56|-0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.09|-0.56|0.0060
70865057|NCT04806503|141216186|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.022|STANDARD_ERROR_OF_MEAN|0.0304||0.474|TWO_SIDED|95.0|-0.038|0.081|||Mixed-effect Model for Repeated Measures|||||0.081|-0.038|0.474
70865058|NCT04806503|141216186|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.025|STANDARD_ERROR_OF_MEAN|0.0309||0.419|TWO_SIDED|95.0|-0.036|0.086|||Mixed-effect Model for Repeated Measures|||||0.086|-0.036|0.419
70865059|NCT04806503|141216186|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.003|STANDARD_ERROR_OF_MEAN|0.0322||0.914||95.0|-0.06|0.067|||Mixed-effect Model for Repeated Measures|||||0.067|-0.060|0.914
70865060|NCT04806503|141216186|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.034|STANDARD_ERROR_OF_MEAN|0.0305||0.263|TWO_SIDED|95.0|-0.026|0.094|||Mixed-effect Model for Repeated Measures|||||0.094|-0.026|0.263
70865061|NCT04806503|141216187|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.029|STANDARD_ERROR_OF_MEAN|0.0273||0.284|TWO_SIDED|95.0|-0.024|0.083|||Mixed-effect Model for Repeated Measures|||||0.083|-0.024|0.284
70865062|NCT04806503|141216187|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.01|STANDARD_ERROR_OF_MEAN|0.0278||0.711|TWO_SIDED|95.0|-0.044|0.065|||Mixed-effect Model for Repeated Measures|||||0.065|-0.044|0.711
70948509|NCT05186311|141398050|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit (CAL).||||||||||||||||One hundred (100) participants (with paired numerical data) per each analyte provide \> 90% power to ensure that mean biases and confidence intervals are within the clinical acceptance limit (CAL), at medically relevant points, assuming no true bias between the tube types, residual standard deviation (SD) or coefficient of variation (CV) = CAL and collected data cover medically relevant points.|"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
71139810|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.71|-0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.24|-0.71|<0.0001
70865063|NCT04806503|141216187|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.005|STANDARD_ERROR_OF_MEAN|0.0284||0.871|TWO_SIDED|95.0|-0.051|0.06|||Mixed-effect Model for Repeated Measures|||||0.060|-0.051|0.871
70865064|NCT04806503|141216187|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.027|STANDARD_ERROR_OF_MEAN|0.0273||0.329|TWO_SIDED|95.0|-0.027|0.08|||Mixed-effect Model for Repeated Measures|||||0.080|-0.027|0.329
71139811|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.85|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.38|-0.85|<0.0001
70865065|NCT04806503|141216188|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.95||||0.516|TWO_SIDED|95.0|0.083|10.847|||Multiple Imputation, Logistic Regression|||||10.847|0.083|0.516
70865066|NCT04806503|141216188|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|2.45||||0.177|TWO_SIDED|95.0|0.367|16.398|||Multiple Imputation, Logistic Regression|||||16.398|0.367|0.177
70865067|NCT04806503|141216188|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|3.65||||0.079|TWO_SIDED|95.0|0.604|22.094|||Multiple Imputation, Logistic Regression|||||22.094|0.604|0.079
70865068|NCT04806503|141216188|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|1.07||||0.476|TWO_SIDED|95.0|0.136|8.381|||Multiple Imputation, Logistic Regression|||||8.381|0.136|0.476
70865069|NCT04806503|141216189|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.87||||0.577|TWO_SIDED|95.0|0.201|3.726|||Multiple Imputation, Logistic Regression|||||3.726|0.201|0.577
70865070|NCT04806503|141216189|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.52||||0.804|TWO_SIDED|95.0|0.113|2.353|||Multiple Imputation, Logistic Regression|||||2.353|0.113|0.804
70865071|NCT04806503|141216189|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.34||||0.85|TWO_SIDED|95.0|0.045|2.602|||Multiple Imputation, Logistic Regression|||||2.602|0.045|0.850
70865072|NCT04806503|141216189|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.69||||0.684|TWO_SIDED|95.0|0.157|3.08|||Multiple Imputation, Logistic Regression|||||3.080|0.157|0.684
70865073|NCT04806503|141216190|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.56||||0.728|TWO_SIDED|95.0|0.089|3.593|||Multiple Imputation, Logistic Regression|||||3.593|0.089|0.728
70865074|NCT04806503|141216190|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|1.16||||0.428|TWO_SIDED|95.0|0.242|5.529|||Multiple Imputation, Logistic Regression|||||5.529|0.242|0.428
70865075|NCT04806503|141216190|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.0||||0.5|TWO_SIDED|95.0|0.0||NA when n = 1.||Multiple Imputation, Logistic Regression||||||0.000|0.500
70865076|NCT04806503|141216190|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.28||||0.851|TWO_SIDED|95.0|0.026|3.07|||Multiple Imputation, Logistic Regression|||||3.070|0.026|0.851
70948510|NCT05186311|141398051|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
70948511|NCT05186311|141398052|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
71139812|NCT03192176|141778519|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.6977|TWO_SIDED|95.0|-0.28|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||0.19|-0.28|0.6977
70872203|NCT01727297|141229672|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.02|TWO_SIDED|95.0|1.01|1.08||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons. BMI was treated as a continuous variable.|Regression, Cox||The hazard ratio represented the effect of a one unit increase in BMI on a patient's risk of developing AF. Descriptive statistics (mean ± standard deviation) for BMI were 31.0 ± 6.6 among patients with AF, and 31.2 ± 6.4 among patients without AF|The null hypothesis was that body mass index (BMI) did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.08|1.01|0.02
71139813|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0121|TWO_SIDED|95.0|-0.53|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.07|-0.53|0.0121
71139814|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0086|TWO_SIDED|95.0|-0.54|-0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.08|-0.54|0.0086
71139815|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.0138|TWO_SIDED|95.0|-0.66|-0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.08|-0.66|0.0138
71139816|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.15||0.0014|TWO_SIDED|95.0|-0.78|-0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.19|-0.78|0.0014
71139817|NCT03192176|141778519|SUPERIORITY||LSMean differencce|-0.7|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.02|-0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.43|-1.02|<0.0001
71139818|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.19|-0.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.59|-1.19|<0.0001
71139819|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.2831|TWO_SIDED|95.0|-0.46|0.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||0.14|-0.46|0.2831
71139820|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.0051|TWO_SIDED|95.0|-0.72|-0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.13|-0.72|0.0051
71139821|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.15||0.0006|TWO_SIDED|95.0|-0.81|-0.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.22|-0.81|0.0006
71139822|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.0058|TWO_SIDED|95.0|-0.83|-0.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.14|-0.83|0.0058
70948512|NCT05186311|141398053|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
71139823|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.18||0.0004|TWO_SIDED|95.0|-0.97|-0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.28|-0.97|0.0004
70865077|NCT00617851|141216213|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (A/H1N1 Strain)|1.09|||||TWO_SIDED|95.0|0.92|1.29|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H01 LotA ≠ LotB versus H1 LotA = LotB H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% confidence interval (CI) on the geometric mean titer (GMT) ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.29|0.92|
70865078|NCT00617851|141216213|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (A/H1N1 Strain)|1.1|||||TWO_SIDED|95.0|0.93|1.31|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H02 LotA ≠ LotC versus H12 LotA = Lotc H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.31|0.93|
70865079|NCT00617851|141216213|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (A/H1N1 Strain)|1.01|||||TWO_SIDED|95.0|0.85|1.2|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotB ≠ LotC versus H13 LotB = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.2|0.85|
70948513|NCT05186311|141398054|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
70948514|NCT05186311|141398055|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
71139824|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.14|-0.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.46|-1.14|<0.0001
71139825|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.27|-0.57||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.57|-1.27|<0.0001
71139826|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.0807|TWO_SIDED|95.0|-0.66|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||0.04|-0.66|0.0807
71139827|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.18||0.0014|TWO_SIDED|95.0|-0.91|-0.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.22|-0.91|0.0014
70865080|NCT00617851|141216213|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (A/H3N2 Strain)|1.12|||||TWO_SIDED|95.0|0.97|1.3|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotA ≠ LotB versus H13 LotA = LotB H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.3|0.97|
70865081|NCT00617851|141216213|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (A/H3N2 strain)|0.98|||||TWO_SIDED|95.0|0.85|1.13|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotA ≠ LotC versus H13 LotA = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.13|0.85|
70865082|NCT00617851|141216213|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (A/H3N2 strain)|0.87|||||TWO_SIDED|95.0|0.76|1.01|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotB ≠ LotC versus H13 LotB = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.01|0.76|
70865083|NCT00617851|141216213|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (B strain)|1.06|||||TWO_SIDED|95.0|0.91|1.23|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotA ≠ LotB versus H13 LotA = LotB H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.23|0.91|
70865084|NCT00617851|141216213|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (B strain)|1.15|||||TWO_SIDED|95.0|0.99|1.33|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotA ≠ LotC versus H13 LotA = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.33|0.99|
70865085|NCT00617851|141216213|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (B strain)|1.09|||||TWO_SIDED|95.0|0.94|1.26|||ANOVA||"The control vaccine arm (n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotB ≠ LotC versus H13 LotB = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.26|0.94|
71139828|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.17||0.0001|TWO_SIDED|95.0|-1.02|-0.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.34|-1.02|0.0001
70948515|NCT05186311|141398056|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
70948516|NCT05186311|141398057|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
70948517|NCT05186311|141398058|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
70948518|NCT05186311|141398059|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
71139829|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.0046|TWO_SIDED|95.0|-0.85|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.16|-0.85|0.0046
71139830|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.18||0.0003|TWO_SIDED|95.0|-0.99|-0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.29|-0.99|0.0003
71139831|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.14|-0.45||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.45|-1.14|<0.0001
71139832|NCT03192176|141778519|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.14|-0.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.70|-1.14|<0.0001
71139833|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0209|TWO_SIDED|95.0|-0.77|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.06|-0.77|0.0209
71139834|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.6|STANDARD_DEVIATION|0.18||0.0011|TWO_SIDED|95.0|-0.93|-0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.24|-0.93|0.0011
71139835|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.07|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.38|-1.07|<0.0001
70865086|NCT01914757|141216230|SUPERIORITY_OR_OTHER||Rate Ratio|0.64||||0.002|TWO_SIDED|95.0|0.49|0.85|||Negative Binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||0.85|0.49|0.002
70865087|NCT01914757|141216230|SUPERIORITY_OR_OTHER||Rate Ratio|0.72||||0.019|TWO_SIDED|95.0|0.54|0.95|||Negative Binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids.||||0.95|0.54|0.019
70865088|NCT01914757|141216231|SUPERIORITY_OR_OTHER||Rate Ratio|0.64||||0.015|TWO_SIDED|95.0|0.45|0.92|||Negative Binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||0.92|0.45|0.015
70865089|NCT01914757|141216231|SUPERIORITY_OR_OTHER||Rate Ratio|0.6||||0.005|TWO_SIDED|95.0|0.42|0.86|||Negative Binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids.||||0.86|0.42|0.005
70865090|NCT01914757|141216232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125||||0.005|TWO_SIDED|95.0|0.037|0.213|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit, and treatment by visit||||0.213|0.037|0.005
70865091|NCT01914757|141216232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.116||||0.01|TWO_SIDED|95.0|0.028|0.204|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit, and treatment by visit||||0.204|0.028|0.01
70865092|NCT01914757|141216233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064||||0.268|TWO_SIDED|95.0|-0.049|0.176|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit, and treatment by visit||||0.176|-0.049|0.268
70865093|NCT01914757|141216233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015||||0.786|TWO_SIDED|95.0|-0.127|0.096|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit, and treatment by visit||||0.096|-0.127|0.786
70865094|NCT01914757|141216234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.224|TWO_SIDED|95.0|-0.32|0.07|||Mixed Models Analysis|Model includes treatment, baseline Asthma symptom score, region, use of OCS, visit, and visit by treatment.||||0.07|-0.32|0.224
71139836|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.0956|TWO_SIDED|95.0|-0.67|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||0.05|-0.67|0.0956
70865095|NCT01914757|141216234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.019|TWO_SIDED|95.0|-0.43|-0.04|||Mixed Models Analysis|Model includes treatment, baseline Asthma symptom score, region, use of OCS, visit, and visit by treatment.||||-0.04|-0.43|0.019
70865096|NCT01914757|141216235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.287|TWO_SIDED|95.0|-0.44|0.13|||Mixed Models Analysis|Model includes treatment, baseline Asthma symptom score, region, use of OCS, visit, and visit by treatment.||||0.13|-0.44|0.287
70865097|NCT01914757|141216235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.966|TWO_SIDED|95.0|-0.28|0.29|||Mixed Models Analysis|Model includes treatment, baseline Asthma symptom score, region, use of OCS, visit, and visit by treatment.||||0.29|-0.28|0.966
70865098|NCT01914757|141216236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.603|TWO_SIDED|95.0|-0.58|0.99|||Mixed Models Analysis|Model includes treatment, baseline Asthma rescue medication use, region, use of OCS, visit, and visit by treatment.||||0.99|-0.58|0.603
70865099|NCT01914757|141216236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.209|TWO_SIDED|95.0|-1.29|0.28|||Mixed Models Analysis|Model includes treatment, baseline Asthma medication use, region, use of OCS, visit, and visit by treatment.||||0.28|-1.29|0.209
71139837|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.005|TWO_SIDED|95.0|-0.89|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.16|-0.89|0.0050
71139838|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.18|-0.45||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.45|-1.18|<0.0001
71139839|NCT03192176|141778519|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.4|-0.65||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.65|-1.40|<0.0001
71139840|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.0915|TWO_SIDED|95.0|-0.69|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||0.05|-0.69|0.0915
71139841|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.0378|TWO_SIDED|95.0|-0.75|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.02|-0.75|0.0378
71139842|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0053|TWO_SIDED|95.0|-0.89|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.16|-0.89|0.0053
71139843|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0614|TWO_SIDED|95.0|-0.83|-0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.08|-0.83|0.0614
71139844|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.004|TWO_SIDED|95.0|-0.92|-0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.18|-0.92|0.0040
71139845|NCT03192176|141778519|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.33|-0.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.58|-1.33|<0.0001
71139846|NCT03192176|141778519|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.47|-0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.71|-1.47|<0.0001
71139847|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.0967|TWO_SIDED|95.0|-0.7|0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||0.06|-0.70|0.0967
71139848|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0063|TWO_SIDED|95.0|-0.9|-0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.15|-0.90|0.0063
71139849|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.13|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.38|-1.13|<0.0001
71139850|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0632|TWO_SIDED|95.0|-0.75|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||0.02|-0.75|0.0632
71139851|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.002|TWO_SIDED|95.0|-1.0|-0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.23|-1.00|0.0020
71139852|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.29|-0.51||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.51|-1.29|<0.0001
71139853|NCT03192176|141778519|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.48|-0.69||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.69|-1.48|<0.0001
71139854|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0308|TWO_SIDED|95.0|-0.82|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.04|-0.82|0.0308
71139855|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.0105|TWO_SIDED|95.0|-0.89|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.12|-0.89|0.0105
71139856|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.001|TWO_SIDED|95.0|-1.03|-0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.26|-1.03|0.0010
71139857|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1469|TWO_SIDED|95.0|-0.69|0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.11|-0.69|0.1469
71139858|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0315|TWO_SIDED|95.0|-0.84|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.04|-0.84|0.0315
71139859|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.21||0.0002|TWO_SIDED|95.0|-1.18|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.38|-1.18|0.0002
70865100|NCT01914757|141216237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.86||||0.029|TWO_SIDED|95.0|1.59|30.12|||Mixed Models Analysis|Model includes treatment, baseline morning PEF, region, use of OCS, visit, and visit by treatment.||Morning PEF Change from Baseline to Week 56||30.12|1.59|0.029
70865101|NCT01914757|141216237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.27||||0.037|TWO_SIDED|95.0|0.9|29.64|||Mixed Models Analysis|Model includes treatment, baseline morning PEF, region, use of OCS, visit, and visit by treatment.||Morning PEF Change from Baseline to Week 56||29.64|0.9|0.037
70865102|NCT01914757|141216237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.54||||0.018|TWO_SIDED|95.0|3.07|32.0|||Mixed Models Analysis|Model includes treatment, baseline evening PEF, region, use of OCS, visit, and visit by treatment.||Evening PEF Change from Baseline to Week 56||32|3.07|0.018
70865103|NCT01914757|141216237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.22||||0.004|TWO_SIDED|95.0|6.65|35.79|||Mixed Models Analysis|Model includes treatment, baseline evening PEF, region, use of OCS, visit, and visit by treatment.||Evening PEF Change from Baseline to Week 56||35.79|6.65|0.004
70865104|NCT01914757|141216238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.4|TWO_SIDED|95.0|-0.06|0.03|||Mixed Models Analysis|Model includes treatment, baseline prop of nights with nocturnal wakening, region, use of OCS, visit, and visit by treatment.||||0.03|-0.06|0.4
70865105|NCT01914757|141216238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.146|TWO_SIDED|95.0|-0.08|0.01|||Mixed Models Analysis|Model includes treatment, baseline prop of nights with nocturnal wakening, region, use of OCS, visit, and visit by treatment.||||0.01|-0.08|0.146
70865106|NCT01914757|141216239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.043|TWO_SIDED|95.0|-0.38|-0.01|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit, and visit by treatment.||||-0.01|-0.38|0.043
70865107|NCT01914757|141216239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.008|TWO_SIDED|95.0|-0.44|-0.07|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit, and visit by treatment.||||-0.07|-0.44|0.008
70865108|NCT01914757|141216240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.078|TWO_SIDED|95.0|-0.51|0.03|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit, and visit by treatment.||||0.03|-0.51|0.078
70865109|NCT01914757|141216240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.449|TWO_SIDED|95.0|-0.37|0.16|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit, and visit by treatment.||||0.16|-0.37|0.449
70865110|NCT01914757|141216241|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.46|||<|0.001|TWO_SIDED|95.0|0.31|0.69|||Cochran-Mantel-Haenszel|Controlling for region, number of exacerbations in the previous year, use of OCS||Proportion of patients with \>=1 asthma exacerbation||0.69|0.31|<0.001
70865111|NCT01914757|141216241|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.023|TWO_SIDED|95.0|0.45|0.95|||Cochran-Mantel-Haenszel|Controlling for region, number of exacerbations in the previous year, use of OCS||Proportion of patients with \>=1 asthma exacerbation||0.95|0.45|0.023
70865112|NCT01914757|141216242|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61|||<|0.001|TWO_SIDED|95.0|0.46|0.8|||Regression, Cox|Model includes treatment, region, number of exacerbations in the previous year, use of OCS||Time to first Exacerbation||0.80|0.46|<0.001
70865113|NCT01914757|141216242|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.018|TWO_SIDED|95.0|0.55|0.95|||Regression, Cox|Model includes treatment, region, number of exacerbations in the previous year, use of OCS||Time to first asthma exacerbation||0.95|0.55|0.018
70865114|NCT01914757|141216243|SUPERIORITY_OR_OTHER||Rate Ratio|0.93||||0.837|TWO_SIDED|95.0|0.48|1.82|||negative binomial|Model includes treatment, region, any prior exacerbation resulting ER/Hospitalization, use of OCS||||1.82|0.48|0.837
70865115|NCT01914757|141216243|SUPERIORITY_OR_OTHER||Rate Ratio|1.23||||0.538|TWO_SIDED|95.0|0.64|2.35|||negative binomial|Model includes treatment, region, any prior exacerbation resulting ER/Hospitalization, use of OCS||||2.35|0.64|0.538
70865116|NCT01914757|141216247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.119|TWO_SIDED|95.0|-0.04|0.37|||Mixed Models Analysis|Model includes treatment, baseline AQLQ score, region, use of OCS, visit, visit by treatment.||||0.37|-0.04|0.119
70865117|NCT01914757|141216247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.019|TWO_SIDED|95.0|0.04|0.45|||Mixed Models Analysis|Model includes treatment, baseline AQLQ score, region, use of OCS, visit, visit by treatment.||||0.45|0.04|0.019
70865118|NCT00333177|141216269|SUPERIORITY||||||<|0.03||||||P value is for CT-HBT X RLAI-Oral Ris interaction|ANCOVA|Covaried baseline value of dependent variable||A priori hypothesis was that CT would be superior to HBT and that RLAI would enhance this effect.||||<0.03
70865119|NCT00333177|141216270|SUPERIORITY||||||<|0.02||||||P-value is for each main effect. A priori threshold for statistical significance was p\<0.05 for each main effect.|ANCOVA|Baseline value of dependent variable was covaried.||2 X 2 ANOVA was calculated. A priori hypotheses were that LAI would be superior to oral risperidone and that CT would be superior to health behavior training (HBT) based on main effects.||||<.02
70865120|NCT00333177|141216271|SUPERIORITY||Mean Difference (Final Values)|0.84||||0.001|TWO_SIDED|95.0|0.57|1.1|||t-test, 2 sided|||A priori hypothesis was that RLAI would lead to less medication non-adherence than Oral Ris.||1.10|.57|.001
71139860|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.26|-0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.43|-1.26|<0.0001
71139861|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.4494|TWO_SIDED|95.0|-0.56|0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.25|-0.56|0.4494
70865121|NCT00333177|141216272|SUPERIORITY||||||<|0.05||||||P-value is for CT vs. HBT main effect.|ANCOVA|Baseline value of dependent variable was covaried.||2 X 2 ANOVA was calculated. A priori hypotheses were that CT would be superior to HBT and that RLAI would be superior to Oral Ris.||||<.05
70865122|NCT00333177|141216273|SUPERIORITY|||||||0.55|||||||ANOVA|||||||0.55
70865123|NCT00333177|141216274|SUPERIORITY||||||<|0.02||||||A priori hypotheses were that CT would be superior to HBT and that RLAI would be superior to Oral Ris.|ANOVA|2 X 2 ANOVA was computed.||||||<0.02
70865124|NCT00333177|141216275|SUPERIORITY||||||<|0.01|||||||Chi-squared|df = 1||Chi-square of frequencies of relapse vs. non-relapse were calculated, with a priori hypothesis that RLAI would be superior to Oral Ris.||||<0.01
70865125|NCT00333177|141216276|SUPERIORITY||||||<|0.05||||||2 X 2 ANOVA calculated. P-value is for main effect of RLAI vs. Oral Ris.|ANOVA|||||||<.05
70865126|NCT00333177|141216277|SUPERIORITY||||||<|0.02||||||2 X 2 ANOVA computed. P-value is for main effect of CT vs. HBT.|ANOVA|||||||<.02
70865127|NCT00333177|141216278|SUPERIORITY||||||=|0.053||||||2 X 2 ANOVA computed. P-value is for RLAI vs. Oral Ris main effect.|ANOVA|||||||=.053
70865128|NCT02833350|141216280|SUPERIORITY||Weighted difference|8.0||||0.2503|TWO_SIDED|95.0|-5.64|21.64|||Cochran-Mantel-Haenszel|||||21.64|-5.64|0.2503
70865129|NCT02833350|141216280|SUPERIORITY||Weighted difference|12.93||||0.0164|TWO_SIDED|95.0|2.37|23.48|||Cochran-Mantel-Haenszel|||||23.48|2.37|0.0164
70865130|NCT02833350|141216280|SUPERIORITY||Weighted difference|20.0||||0.0003|TWO_SIDED|95.0|9.21|30.79|||Cochran-Mantel-Haenszel|||||30.79|9.21|0.0003
70865131|NCT02833350|141216282|SUPERIORITY||Weighted difference|-8.58||||0.1694|TWO_SIDED|95.0|-20.82|3.66|||Cochran-Mantel-Haenszel|||||3.66|-20.82|0.1694
70865132|NCT02833350|141216282|SUPERIORITY||Weighted difference|-1.5||||0.8132||95.0|-13.96|10.95|||Cochran-Mantel-Haenszel|||||10.95|-13.96|0.8132
70865133|NCT02833350|141216283|SUPERIORITY||Weighted difference|13.7||||0.0717|TWO_SIDED|95.0|-1.21|28.61|||Cochran-Mantel-Haenszel|||||28.61|-1.21|0.0717
70865134|NCT02833350|141216287|SUPERIORITY||adjusted difference|-0.11||||0.8504|TWO_SIDED|95.0|-0.45|0.23|||ANCOVA|||Week 1, Day 7||0.23|-0.45|0.8504
70865135|NCT02833350|141216287|SUPERIORITY||Adjusted Difference|-0.04||||0.9884|TWO_SIDED|95.0|-0.28|0.21|||ANCOVA|||At week 1, Day 7||0.21|-0.28|0.9884
70865136|NCT02833350|141216287|SUPERIORITY||Adjusted Difference|-0.06||||0.923|TWO_SIDED|95.0|-0.31|0.18|||ANCOVA|||Week 1 Day 7||0.18|-0.31|0.9230
70865137|NCT02833350|141216287|SUPERIORITY||Adjusted Difference|-0.06||||0.9853|TWO_SIDED|95.0|-0.43|0.31|||ANCOVA|||Week 2, Day 14||0.31|-0.43|0.9853
70865138|NCT02833350|141216287|SUPERIORITY||Adjusted Difference|-0.12||||0.6826|TWO_SIDED|95.0|-0.38|0.15|||ANCOVA|||Week 2, Day 14||0.15|-0.38|0.6826
70865139|NCT02833350|141216287|SUPERIORITY||Adjusted Difference|-0.18||||0.2634|TWO_SIDED|95.0|-0.45|0.08|||ANCOVA|||Week 2, Day 14||0.08|-0.45|0.2634
70865140|NCT02833350|141216287|SUPERIORITY||Adjusted Difference|-0.29||||0.2885|TWO_SIDED|95.0|-0.72|0.14|||ANCOVA|||Week 4, Day 28||0.14|-0.72|0.2885
70865141|NCT02833350|141216287|SUPERIORITY||Adjusted Difference|-0.3||||0.0598|TWO_SIDED|95.0|-0.61|0.01|||ANCOVA|||Week 4, Day 28||0.01|-0.61|0.0598
70865142|NCT02833350|141216287|SUPERIORITY||Adjusted Difference|-0.31||||0.044|TWO_SIDED|95.0|-0.62|-0.01|||ANCOVA|||Week 4, Day 28||-0.01|-0.62|0.0440
70865143|NCT02833350|141216287|SUPERIORITY||Adjusted Difference|-0.28||||0.4271|TWO_SIDED|95.0|-0.76|0.2|||ANCOVA|||Week 8, Day 56||0.20|-0.76|0.4271
70865144|NCT02833350|141216287|SUPERIORITY||Adjusted Difference|-0.31||||0.0969|TWO_SIDED|95.0|-0.66|0.04|||ANCOVA|||Week 8, Day 56||0.04|-0.66|0.0969
70865145|NCT02833350|141216287|SUPERIORITY||Adjusted Difference|-0.33||||0.0612|TWO_SIDED|95.0|-0.68|0.01|||ANCOVA|||Week 8, Day 56||0.01|-0.68|0.0612
70865146|NCT02833350|141216287|SUPERIORITY||Adjusted Difference|-0.36||||0.2079|TWO_SIDED|95.0|-0.84|0.12|||ANCOVA|||Week 12, Day 84||0.12|-0.84|0.2079
70865147|NCT02833350|141216287|SUPERIORITY||Adjusted Difference|-0.57||||0.0003|TWO_SIDED|95.0|-0.92|-0.22|||ANCOVA|||Week 12, Day 84||-0.22|-0.92|0.0003
70865148|NCT02833350|141216287|SUPERIORITY||Adjusted Difference|-0.57||||0.0003|TWO_SIDED|95.0|-0.92|-0.22|||ANCOVA|||Week 12, Day 84||-0.22|-0.92|0.0003
70865149|NCT02833350|141216287|SUPERIORITY||Adjusted Difference|0.58|||<|0.0001|TWO_SIDED|95.0|0.34|0.82|||ANCOVA|||Week 1, Day 7||0.82|0.34|<.0001
70865150|NCT02833350|141216287|SUPERIORITY||Mean Difference (Net)|0.55|||<|0.0001|TWO_SIDED|95.0|0.31|0.8|||ANCOVA|||Week 1, Day 7||0.80|0.31|<0.0001
70865151|NCT02833350|141216287|SUPERIORITY||Adjusted Difference|0.47|||<|0.0001|TWO_SIDED|95.0|0.2|0.74|||ANCOVA|||Week 2, Day 14||0.74|0.20|<.0001
70865152|NCT02833350|141216287|SUPERIORITY||Adjusted Difference|0.4||||0.0009|TWO_SIDED|95.0|0.13|0.66|||ANCOVA|||Week 2, Day 14||0.66|0.13|0.0009
70865153|NCT02833350|141216287|SUPERIORITY||Adjusted Difference|0.56|||<|0.0001|TWO_SIDED|95.0|0.25|0.87|||ANCOVA|||Week 4, Day 28||0.87|0.25|<.0001
70865154|NCT02833350|141216287|SUPERIORITY||Adjusted Difference|0.55|||<|0.0001|TWO_SIDED|95.0|0.24|0.85|||ANCOVA|||Week 4, Day 28||0.85|0.24|<.0001
70865155|NCT02833350|141216287|SUPERIORITY||Adjusted Difference|0.42||||0.0095|TWO_SIDED|95.0|0.08|0.76|||ANCOVA|||Week 8, Day 56||0.76|0.08|0.0095
70865156|NCT02833350|141216287|SUPERIORITY||Adjusted Difference|0.4||||0.0153|TWO_SIDED|95.0|0.06|0.74|||ANCOVA|||Week 8, Day 56||0.74|0.06|0.0153
70865157|NCT02833350|141216287|SUPERIORITY||Adjusted Difference|0.19||||0.4839|TWO_SIDED|95.0|-0.16|0.54|||ANCOVA|||Week 12, Day 84||0.54|-0.16|0.4839
70865158|NCT02833350|141216287|SUPERIORITY||Adjusted Difference|0.19||||0.5035|TWO_SIDED|95.0|-0.16|0.53|||ANCOVA|||Week 12, Day 84||0.53|-0.16|0.5035
70865159|NCT02833350|141216287|SUPERIORITY||Adjusted Difference|-0.11||||0.4286|TWO_SIDED|95.0|-0.38|0.16|||ANCOVA|||Week 1, Day 7||0.16|-0.38|0.4286
70865160|NCT02833350|141216287|SUPERIORITY||Adjusted Difference|-0.2||||0.1831|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||Week 2, Day 14||0.10|-0.50|0.1831
70865161|NCT02833350|141216287|SUPERIORITY||Adjusted Difference|-0.31||||0.0667|TWO_SIDED|95.0|-0.65|0.02|||ANCOVA|||Week 4, Day 28||0.02|-0.65|0.0667
70865162|NCT02833350|141216287|SUPERIORITY||Adjusted Difference|-0.77|||<|0.0001|TWO_SIDED|95.0|-1.11|-0.42|||ANCOVA|||Week 8, Day 56||-0.42|-1.11|<0.0001
70865163|NCT02833350|141216287|SUPERIORITY||Adjusted Difference|-0.76||||0.0002|TWO_SIDED|95.0|-1.15|-0.38|||ANCOVA|||Week 12, Day 84||-0.38|-1.15|0.0002
70865164|NCT02833350|141216288|SUPERIORITY||Adjusted Difference|-0.18||||0.5807|TWO_SIDED|95.0|-0.55|0.19|||ANCOVA|||Week 1, Day 7||0.19|-0.55|0.5807
70865165|NCT02833350|141216288|SUPERIORITY||Adjusted Difference|-0.12||||0.627|TWO_SIDED|95.0|-0.39|0.14|||ANCOVA|||Week 1, Day 7||0.14|-0.39|0.6270
70865166|NCT02833350|141216288|SUPERIORITY||Adjusted Difference|-0.15||||0.4475|TWO_SIDED|95.0|-0.42|0.12|||ANCOVA|||Week 1, Day 7||0.12|-0.42|0.4475
70865167|NCT02833350|141216288|SUPERIORITY||Adjusted Difference|-0.06||||0.9891|TWO_SIDED|95.0|-0.47|0.35|||ANCOVA|||Week 2, Day 14||0.35|-0.47|0.9891
70865168|NCT02833350|141216288|SUPERIORITY||Adjusted Difference|-0.21||||0.2244|TWO_SIDED|95.0|-0.51|0.08|||ANCOVA|||Week 2, Day 14||0.08|-0.51|0.2244
70865169|NCT02833350|141216288|SUPERIORITY||Adjusted Difference|-0.28||||0.0586|TWO_SIDED|95.0|-0.58|0.01|||ANCOVA|||Week 2, Day 14||0.01|-0.58|0.0586
70865170|NCT02833350|141216288|SUPERIORITY||Adjusted Difference|-0.39||||0.1338|TWO_SIDED|95.0|-0.85|0.08|||ANCOVA|||Week 4, Day 28||0.08|-0.85|0.1338
70865171|NCT02833350|141216288|SUPERIORITY||Adjusted Difference|-0.4||||0.0119|TWO_SIDED|95.0|-0.74|-0.07|||ANCOVA|||Week 4, Day 28||-0.07|-0.74|0.0119
70865172|NCT02833350|141216288|SUPERIORITY||Adjusted Difference|-0.44||||0.0046|TWO_SIDED|95.0|-0.77|-0.11|||ANCOVA|||Week 4, Day 28||-0.11|-0.77|0.0046
70865173|NCT02833350|141216288|SUPERIORITY||Adjusted Difference|-0.31||||0.3943|TWO_SIDED|95.0|-0.82|0.2|||ANCOVA|||Week 8, Day 56||0.20|-0.82|0.3943
70865174|NCT02833350|141216288|SUPERIORITY||Adjusted Difference|-0.37||||0.0526|TWO_SIDED|95.0|-0.74|0.0|||ANCOVA|||Week 8, Day 56||0.00|-0.74|0.0526
70865175|NCT02833350|141216288|SUPERIORITY||Adjusted Difference|-0.39||||0.0365|TWO_SIDED|95.0|-0.76|-0.02|||ANCOVA|||Week 8, Day 56||-0.02|-0.76|0.0365
70865176|NCT02833350|141216288|SUPERIORITY||Adjusted Difference|-0.41||||0.1696|TWO_SIDED|95.0|-0.93|0.11|||ANCOVA|||Week 12, Day 84||0.11|-0.93|0.1696
70865177|NCT02833350|141216288|SUPERIORITY||Adjusted Difference|-0.63||||0.0002|TWO_SIDED|95.0|-1.01|-0.25|||ANCOVA|||Week 12, Day 84||-0.25|-1.01|0.0002
70865178|NCT02833350|141216288|SUPERIORITY||Adjusted Difference|-0.62||||0.0003|TWO_SIDED|95.0|-1.0|-0.24|||ANCOVA|||Week 12, Day 84||-0.24|-1.00|0.0003
70865179|NCT02833350|141216288|SUPERIORITY||Adjusted Difference|0.64|||<|0.0001|TWO_SIDED|95.0|0.37|0.9|||ANCOVA|||Week 1, Day 7||0.90|0.37|<0.0001
70865180|NCT02833350|141216288|SUPERIORITY||Adjusted Difference|0.61|||<|0.0001|TWO_SIDED|95.0|0.34|0.88|||ANCOVA|||Week 1, Day 7||0.88|0.34|<0.0001
70865181|NCT02833350|141216288|SUPERIORITY||Adjusted Difference|0.5||||0.0001|TWO_SIDED|95.0|0.21|0.79|||ANCOVA|||Week 2, Day 14||0.79|0.21|0.0001
70865182|NCT02833350|141216288|SUPERIORITY||Adjusted Difference|0.43||||0.0012|TWO_SIDED|95.0|0.14|0.72|||ANCOVA|||Week 2, Day 14||0.72|0.14|0.0012
70865183|NCT02833350|141216288|SUPERIORITY||Adjusted Difference|0.58|||<|0.0001|TWO_SIDED|95.0|0.25|0.91|||ANCOVA|||Week 4, Day 28||0.91|0.25|<0.0001
70865184|NCT02833350|141216288|SUPERIORITY||Adjusted Difference|0.54||||0.0002|TWO_SIDED|95.0|0.21|0.87|||ANCOVA|||Week 4, Day 28||0.87|0.21|0.0002
70865185|NCT02833350|141216288|SUPERIORITY||Adjusted Difference|0.46||||0.0084|TWO_SIDED|95.0|0.09|0.82|||ANCOVA|||Week 8, Day 56||0.82|0.09|0.0084
70865186|NCT02833350|141216288|SUPERIORITY||Adjusted Difference|0.44||||0.0124|TWO_SIDED|95.0|0.07|0.8|||ANCOVA|||Week 8, Day 56||0.80|0.07|0.0124
70865187|NCT02833350|141216288|SUPERIORITY||Adjusted Difference|0.15||||0.7565|TWO_SIDED|95.0|-0.23|0.52|||ANCOVA|||Week 12, Day 84||0.52|-0.23|0.7565
70865188|NCT02833350|141216288|SUPERIORITY||Adjusted Difference|0.16||||0.7158|TWO_SIDED|95.0|-0.22|0.53|||ANCOVA|||Week 12, Day 84||0.53|-0.22|0.7158
70865189|NCT02833350|141216288|SUPERIORITY||Adjusted Difference|-0.22||||0.1368|TWO_SIDED|95.0|-0.52|0.07|||ANCOVA|||Week 1, Day 7||0.07|-0.52|0.1368
70865190|NCT02833350|141216288|SUPERIORITY||Adjusted Difference|-0.28||||0.0974|TWO_SIDED|95.0|-0.62|0.05|||ANCOVA|||Week 2, Day 14||0.05|-0.62|0.0974
70865191|NCT02833350|141216288|SUPERIORITY||Adjusted Difference|-0.38||||0.0479|TWO_SIDED|95.0|-0.76|0.0|||ANCOVA|||Week 4, Day 28||-0.00|-0.76|0.0479
70865192|NCT02833350|141216288|SUPERIORITY||Adjusted Difference|-0.84|||<|0.0001|TWO_SIDED|95.0|-1.22|-0.46|||ANCOVA|||Week 8, Day 56||-0.46|-1.22|<0.0001
70865193|NCT02833350|141216288|SUPERIORITY||Adjusted Difference|-0.83||||0.0001|TWO_SIDED|95.0|-1.24|-0.42|||ANCOVA|||Week 12, Day 84||-0.42|-1.24|0.0001
70865194|NCT02833350|141216289|SUPERIORITY||Adjusted Difference|-0.09||||0.9193|TWO_SIDED|95.0|-0.41|0.24|||ANCOVA|||Week 1, Day 7||0.24|-0.41|0.9193
70865195|NCT02833350|141216289|SUPERIORITY||Adjusted Difference|-0.1||||0.7062|TWO_SIDED|95.0|-0.33|0.14|||ANCOVA|||Week 1, Day 7||0.14|-0.33|0.7062
70865196|NCT02833350|141216289|SUPERIORITY||Adjusted Difference|-0.08||||0.8542|TWO_SIDED|95.0|-0.31|0.16|||ANCOVA|||Week 1, Day 7||0.16|-0.31|0.8542
70865197|NCT02833350|141216289|SUPERIORITY||Adjusted Difference|-0.13||||0.8095|TWO_SIDED|95.0|-0.51|0.24|||ANCOVA|||Week 2, Day 14||0.24|-0.51|0.8095
70865198|NCT02833350|141216289|SUPERIORITY||Adjusted Difference|-0.17||||0.3862|TWO_SIDED|95.0|-0.44|0.11|||ANCOVA|||Week 2, Day 14||0.11|-0.44|0.3862
70865199|NCT02833350|141216289|SUPERIORITY||Adjusted Difference|-0.16||||0.4328|TWO_SIDED|95.0|-0.43|0.12|||ANCOVA|||Week 2, Day 14||0.12|-0.43|0.4328
70865200|NCT02833350|141216289|SUPERIORITY||Adjusted Difference|-0.24||||0.4915|TWO_SIDED|95.0|-0.68|0.2|||ANCOVA|||Week 4, Day 28||0.20|-0.68|0.4915
70865201|NCT02833350|141216289|SUPERIORITY||Adjusted Difference|-0.26||||0.1441|TWO_SIDED|95.0|-0.58|0.06|||ANCOVA|||Week 4, Day 28||0.06|-0.58|0.1441
70865202|NCT02833350|141216289|SUPERIORITY||Adjusted Difference|-0.24||||0.189|TWO_SIDED|95.0|-0.56|0.07|||ANCOVA|||Week 4, Day 28||0.07|-0.56|0.1890
70865203|NCT02833350|141216289|SUPERIORITY||Adjusted Difference|-0.25||||0.5566|TWO_SIDED|95.0|-0.74|-0.24|||ANCOVA|||Week 8, Day 56||-0.24|-0.74|0.5566
70865204|NCT02833350|141216289|SUPERIORITY||Adjusted Difference|-0.32||||0.092|TWO_SIDED|95.0|-0.68|0.04|||ANCOVA|||Week 8, Day 56||0.04|-0.68|0.0920
70865205|NCT02833350|141216289|SUPERIORITY||Adjusted Difference|-0.29||||0.1391|TWO_SIDED|95.0|-0.65|0.06|||ANCOVA|||Week 8, Day 56||0.06|-0.65|0.1391
70865206|NCT02833350|141216289|SUPERIORITY||Adjusted Difference|-0.35||||0.2873|TWO_SIDED|95.0|-0.86|0.17|||ANCOVA|||Week 12, Day 84||0.17|-0.86|0.2873
70865207|NCT02833350|141216289|SUPERIORITY||Adjusted Difference|-0.54||||0.002|TWO_SIDED|95.0|-0.91|-0.16|||ANCOVA|||Week 12, Day 84||-0.16|-0.91|0.0020
70865208|NCT02833350|141216289|SUPERIORITY||Adjusted Difference|-0.54||||0.0016|TWO_SIDED|95.0|-0.92|-0.17|||ANCOVA|||Week 12, Day 84||-0.17|-0.92|0.0016
70865209|NCT02833350|141216289|SUPERIORITY||Adjusted Difference|0.31||||0.005|TWO_SIDED|95.0|0.07|0.55|||ANCOVA|||Week 1, Day 7||0.55|0.07|0.0050
70865210|NCT02833350|141216289|SUPERIORITY||Adjusted Difference|0.33||||0.002|TWO_SIDED|95.0|0.1|0.57|||ANCOVA|||Week 1, Day 7||0.57|0.10|0.0020
70865211|NCT02833350|141216289|SUPERIORITY||Adjusted Difference|0.35||||0.0082|TWO_SIDED|95.0|0.07|0.62|||ANCOVA|||Week 2, Day 14||0.62|0.07|0.0082
70865212|NCT02833350|141216289|SUPERIORITY||Adjusted Difference|0.35||||0.0056|TWO_SIDED|95.0|0.08|0.63|||ANCOVA|||Week 2, Day 14||0.63|0.08|0.0056
70865213|NCT02833350|141216289|SUPERIORITY||Adjusted Difference|0.5||||0.0004|TWO_SIDED|95.0|0.19|0.82|||ANCOVA|||Week 4, Day 28||0.82|0.19|0.0004
70865214|NCT02833350|141216289|SUPERIORITY||Adjusted Difference|0.52||||0.0002|TWO_SIDED|95.0|0.21|0.84|||ANCOVA|||Week 4, Day 28||0.84|0.21|0.0002
70865215|NCT02833350|141216289|SUPERIORITY||Adjusted Difference|0.34||||0.065|TWO_SIDED|95.0|-0.01|0.69|||ANCOVA|||Week 8, Day 56||0.69|-0.01|0.0650
70865216|NCT02833350|141216289|SUPERIORITY||Adjusted Difference|0.37||||0.0365|TWO_SIDED|95.0|0.02|0.72|||ANCOVA|||Week 8, Day 56||0.72|0.02|0.0365
70865217|NCT02833350|141216289|SUPERIORITY||Adjusted Difference|0.09||||0.9338|TWO_SIDED|95.0|-0.28|0.47|||ANCOVA|||Week 12, Day 84||0.47|-0.28|0.9338
70865218|NCT02833350|141216289|SUPERIORITY||Adjusted Difference|0.09||||0.952|TWO_SIDED|95.0|-0.29|0.46|||ANCOVA|||Week 12, Day 84||0.46|-0.29|0.9520
70865219|NCT02833350|141216289|SUPERIORITY||Adjusted Difference|-0.19||||0.1496|TWO_SIDED|95.0|-0.45|0.07|||ANCOVA|||Week 1, Day 7||0.07|-0.45|0.1496
70865220|NCT02833350|141216289|SUPERIORITY||Adjusted Difference|-0.13||||0.3936|TWO_SIDED|95.0|-0.43|0.17|||ANCOVA|||Week 2, Day 14||0.17|-0.43|0.3936
70865221|NCT02833350|141216289|SUPERIORITY||Adjusted Difference|-0.35||||0.0346|TWO_SIDED|95.0|-0.68|-0.03|||ANCOVA|||Week 4, Day 28||-0.03|-0.68|0.0346
70865222|NCT02833350|141216289|SUPERIORITY||Adjusted Difference|-0.68||||0.0004|TWO_SIDED|95.0|-1.04|-0.31|||ANCOVA|||Week 8, Day 56||-0.31|-1.04|0.0004
70865223|NCT02833350|141216289|SUPERIORITY||Adjusted Difference|-0.73||||0.0003|TWO_SIDED|95.0|-1.11|-0.34|||ANCOVA|||Week 12, Day 84||-0.34|-1.11|0.0003
70865224|NCT02833350|141216290|SUPERIORITY||Adjusted Difference|-0.17||||0.6083|TWO_SIDED|95.0|-0.53|0.19|||ANCOVA|||Week 1, Day 7||0.19|-0.53|0.6083
70865225|NCT02833350|141216290|SUPERIORITY||Adjusted Difference|-0.18||||0.2672|TWO_SIDED|95.0|-0.44|0.08|||ANCOVA|||Week 1, Day 7||0.08|-0.44|0.2672
70865226|NCT02833350|141216290|SUPERIORITY||Adjusted Difference|-0.17||||0.3158|TWO_SIDED|95.0|-0.43|0.09|||ANCOVA|||Week 1, Day 7||0.09|-0.43|0.3158
70865227|NCT02833350|141216290|SUPERIORITY||Adjusted Difference|-0.14||||0.8495|TWO_SIDED|95.0|-0.55|0.28|||ANCOVA|||Week 2, Day 14||0.28|-0.55|0.8495
70865228|NCT02833350|141216290|SUPERIORITY||Adjusted Difference|-0.28||||0.0856|TWO_SIDED|95.0|-0.58|0.03|||ANCOVA|||Week 2, Day 14||0.03|-0.58|0.0856
70865229|NCT02833350|141216290|SUPERIORITY||Adjusted Difference|-0.27||||0.1021|TWO_SIDED|95.0|-0.57|0.04|||ANCOVA|||Week 2, Day 14||0.04|-0.57|0.1021
70865230|NCT02833350|141216290|SUPERIORITY||Adjusted Difference|-0.33||||0.2762|TWO_SIDED|95.0|-0.82|0.15|||ANCOVA|||Week 4, Day 28||0.15|-0.82|0.2762
70865231|NCT02833350|141216290|SUPERIORITY||Adjusted Difference|-0.38||||0.0286|TWO_SIDED|95.0|-0.73|-0.03|||ANCOVA|||Week 4, Day 28||-0.03|-0.73|0.0286
70865232|NCT02833350|141216290|SUPERIORITY||Adjusted Difference|-0.38||||0.0274|TWO_SIDED|95.0|-0.73|-0.03|||ANCOVA|||Week 4, Day 28||-0.03|-0.73|0.0274
70865233|NCT02833350|141216290|SUPERIORITY||Adjusted Difference|-0.28||||0.4981|TWO_SIDED|95.0|-0.81|0.24|||ANCOVA|||Week 8, Day 56||0.24|-0.81|0.4981
70865234|NCT02833350|141216290|SUPERIORITY||Adjusted Difference|-0.39||||0.0472|TWO_SIDED|95.0|-0.78|0.0|||ANCOVA|||Week 8, Day 56||-0.00|-0.78|0.0472
70865235|NCT02833350|141216290|SUPERIORITY||Adjusted Difference|-0.36||||0.0753|TWO_SIDED|95.0|-0.75|0.03|||ANCOVA|||Week 8, Day 56||0.03|-0.75|0.0753
70865236|NCT02833350|141216290|SUPERIORITY||Adjusted Difference|-0.43||||0.1853|TWO_SIDED|95.0|-0.99|0.13|||ANCOVA|||Week 12, Day 84||0.13|-0.99|0.1853
70865237|NCT02833350|141216290|SUPERIORITY||Adjusted Difference|-0.62||||0.0009|TWO_SIDED|95.0|-1.03|-0.21|||ANCOVA|||Week 12, Day 84||-0.21|-1.03|0.0009
70865238|NCT02833350|141216290|SUPERIORITY||Adjusted Difference|-0.62||||0.0008|TWO_SIDED|95.0|-1.03|-0.21|||ANCOVA|||Week 12, Day 84||-0.21|-1.03|0.0008
70865239|NCT02833350|141216290|SUPERIORITY||Adjusted Difference|0.41||||0.0005|TWO_SIDED|95.0|0.15|0.67|||ANCOVA|||Week 1, Day 7||0.67|0.15|0.0005
70865240|NCT02833350|141216290|SUPERIORITY||Adjusted Difference|0.42||||0.0003|TWO_SIDED|95.0|0.16|0.68|||ANCOVA|||Week 1, Day 7||0.68|0.16|0.0003
70865241|NCT02833350|141216290|SUPERIORITY||Adjusted Difference|0.39||||0.006|TWO_SIDED|95.0|0.09|0.69|||ANCOVA|||Week 2, Day 14||0.69|0.09|0.0060
70865242|NCT02833350|141216290|SUPERIORITY||Adjusted Difference|0.4||||0.0039|TWO_SIDED|95.0|0.1|0.7|||ANCOVA|||Week 2, Day 14||0.70|0.10|0.0039
70865243|NCT02833350|141216290|SUPERIORITY||Adjusted Difference|0.53||||0.0007|TWO_SIDED|95.0|0.18|0.88|||ANCOVA|||Week 4, Day 28||0.88|0.18|0.0007
70865244|NCT02833350|141216290|SUPERIORITY||Adjusted Difference|0.53||||0.0007|TWO_SIDED|95.0|0.19|0.88|||ANCOVA|||Week 4, Day 28||0.88|0.19|0.0007
70865245|NCT02833350|141216290|SUPERIORITY||Adjusted Difference|0.39||||0.045|TWO_SIDED|95.0|0.01|0.77|||ANCOVA|||Week 8, Day 56||0.77|0.01|0.0450
70865246|NCT02833350|141216290|SUPERIORITY||Adjusted Difference|0.42||||0.0259|TWO_SIDED|95.0|0.04|0.8|||ANCOVA|||Week 8, Day 56||0.80|0.04|0.0259
70865247|NCT02833350|141216290|SUPERIORITY||Adjusted Difference|0.06||||0.9881|TWO_SIDED|95.0|-0.34|0.46|||ANCOVA|||Week 12, Day 84||0.46|-0.34|0.9881
70865248|NCT02833350|141216290|SUPERIORITY||Adjusted Difference|0.06||||0.9891|TWO_SIDED|95.0|-0.34|0.46|||ANCOVA|||Week 12, Day 84||0.46|-0.34|0.9891
70865249|NCT02833350|141216290|SUPERIORITY||Adjusted Difference|-0.29||||0.0463|TWO_SIDED|95.0|-0.57|0.0|||ANCOVA|||Week 1, Day 7||-0.00|-0.57|0.0463
70865250|NCT02833350|141216290|SUPERIORITY||Adjusted Difference|-0.23||||0.1867|TWO_SIDED|95.0|-0.56|0.11|||ANCOVA|||Week 2, Day 14||0.11|-0.56|0.1867
70865251|NCT02833350|141216290|SUPERIORITY||Adjusted Difference|-0.44||||0.0213|TWO_SIDED|95.0|-0.81|-0.07|||ANCOVA|||Week 4, Day 28||-0.07|-0.81|0.0213
70865252|NCT02833350|141216290|SUPERIORITY||Adjusted Difference|-0.78||||0.0003|TWO_SIDED|95.0|-1.19|-0.37|||ANCOVA|||Week 8. Day 56||-0.37|-1.19|0.0003
70865253|NCT02833350|141216290|SUPERIORITY||Adjusted Difference|-0.82||||0.0002|TWO_SIDED|95.0|-1.24|-0.4|||ANCOVA|||Week 12, Day 84||-0.40|-1.24|0.0002
70865254|NCT02833350|141216291|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 1, Day 7||6.06|-6.06|1.0000
70865255|NCT02833350|141216291|SUPERIORITY||Adjusted Difference|0.91||||0.5976|TWO_SIDED|95.0|-2.48|4.3|||Cochran-Mantel-Haenszel|||Week 1, Day 7||4.30|-2.48|0.5976
70865256|NCT02833350|141216291|SUPERIORITY||Adjusted Difference|1.82||||0.3482|TWO_SIDED|95.0|-1.98|5.62|||Cochran-Mantel-Haenszel|||Week 1, Day 7||5.62|-1.98|0.3482
70865257|NCT02833350|141216291|SUPERIORITY||Adjusted Difference|-0.4||||0.8979|TWO_SIDED|95.0|-6.51|5.71|||Cochran-Mantel-Haenszel|||Week 2, Day 14||5.71|-6.51|0.8979
70865258|NCT02833350|141216291|SUPERIORITY||Adjusted Difference|-0.91||||0.5976|TWO_SIDED|95.0|-4.3|2.48|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.48|-4.30|0.5976
70865259|NCT02833350|141216291|SUPERIORITY||Adjusted Difference|0.91||||0.6546|TWO_SIDED|95.0|-3.07|4.89|||Cochran-Mantel-Haenszel|||Week 2, Day 14||4.89|-3.07|0.6546
70865260|NCT02833350|141216291|SUPERIORITY||Adjusted Difference|-0.8||||0.7988|TWO_SIDED|95.0|-6.95|5.35|||Cochran-Mantel-Haenszel|||Week 4 Day 28||5.35|-6.95|0.7988
70865261|NCT02833350|141216291|SUPERIORITY||Adjusted Difference|0.01||||0.9975|TWO_SIDED|95.0|-4.35|4.36|||Cochran-Mantel-Haenszel|||Week 4 Day 28||4.36|-4.35|0.9975
70865262|NCT02833350|141216291|SUPERIORITY||Adjusted Difference|4.55||||0.1185|TWO_SIDED|95.0|-1.16|10.25|||Cochran-Mantel-Haenszel|||Week 4, Day 28||10.25|-1.16|0.1185
71139862|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0595|TWO_SIDED|95.0|-0.79|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.02|-0.79|0.0595
71139863|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0065|TWO_SIDED|95.0|-0.96|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.16|-0.96|0.0065
71139864|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0745|TWO_SIDED|95.0|-0.77|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.04|-0.77|0.0745
71139865|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.054|TWO_SIDED|95.0|-0.8|0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.01|-0.80|0.0540
71139866|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.21||0.0001|TWO_SIDED|95.0|-1.22|-0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.41|-1.22|0.0001
71139867|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.26|-0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.43|-1.26|<0.0001
70865263|NCT02833350|141216291|SUPERIORITY||Adjusted Difference|-2.4||||0.4765|TWO_SIDED|95.0|-9.01|4.21|||Cochran-Mantel-Haenszel|||Week 8, Day 56||4.21|-9.01|0.4765
70865264|NCT02833350|141216291|SUPERIORITY||Adjusted Difference|4.61||||0.1655|TWO_SIDED|95.0|-1.9|11.12|||Cochran-Mantel-Haenszel|||Week 8, Day 56||11.12|-1.90|0.1655
71139868|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.5317|TWO_SIDED|95.0|-0.54|0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.28|-0.54|0.5317
71139869|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0424|TWO_SIDED|95.0|-0.83|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.01|-0.83|0.0424
71139870|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0134|TWO_SIDED|95.0|-0.91|-0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.11|-0.91|0.0134
70865265|NCT02833350|141216291|SUPERIORITY||Adjusted Difference|8.18||||0.0234|TWO_SIDED|95.0|1.11|15.26|||Cochran-Mantel-Haenszel|||Week 8, Day 56||15.26|1.11|0.0234
70865266|NCT02833350|141216291|SUPERIORITY||Adjusted Difference|3.2||||0.549|TWO_SIDED|95.0|-7.27|13.67|||Cochran-Mantel-Haenszel|||Week 12, Day 84||13.67|-7.27|0.5490
70865267|NCT02833350|141216291|SUPERIORITY||Mean Difference (Net)|15.62||||0.0003|TWO_SIDED|95.0|7.22|24.03|||Cochran-Mantel-Haenszel|||Week 12, Day 84||24.03|7.22|0.0003
70865268|NCT02833350|141216291|SUPERIORITY||Adjusted Difference|10.91||||0.0044|TWO_SIDED|95.0|3.39|18.43|||Cochran-Mantel-Haenszel|||Week 12, Day 84||18.43|3.39|0.0044
70865269|NCT02833350|141216291|SUPERIORITY||Adjusted Difference|2.05||||0.6588|TWO_SIDED|95.0|-7.07|11.18|||Cochran-Mantel-Haenszel|||Week 1, Day 7||11.18|-7.07|0.6588
70865270|NCT02833350|141216291|SUPERIORITY||Adjusted Difference|0.68||||0.8853|TWO_SIDED|95.0|-8.62|9.99|||Cochran-Mantel-Haenszel|||Week 2, Day 14||9.99|-8.62|0.8853
70865271|NCT02833350|141216291|SUPERIORITY||Adjusted Difference|2.05||||0.6564|TWO_SIDED|95.0|-7.0|11.11|||Cochran-Mantel-Haenszel|||Week 4, Day 28||11.11|-7.00|0.6564
70865272|NCT02833350|141216291|SUPERIORITY||Adjusted Difference|0.68||||0.8853|TWO_SIDED|95.0|-8.62|9.99|||Cochran-Mantel-Haenszel|||Week 8, Day 56||9.99|-8.62|0.8853
70865273|NCT02833350|141216291|SUPERIORITY||Adjusted Difference|11.64||||0.0584|TWO_SIDED|95.0|-0.41|23.7|||Cochran-Mantel-Haenszel|||Week 12, Day 84||23.70|-0.41|0.0584
70865274|NCT02833350|141216292|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 1, Day 7||6.06|-6.06|1.0000
70865275|NCT02833350|141216292|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.92|2.92|||Cochran-Mantel-Haenszel|||Week 1, Day 7||2.92|-2.92|1.0000
70865276|NCT02833350|141216292|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.91|2.91|||Cochran-Mantel-Haenszel|||Week 1, Day 7||2.91|-2.91|1.0000
70865277|NCT02833350|141216292|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 2, Day 14||6.06|-6.06|1.0000
71139871|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.03|TWO_SIDED|95.0|-0.84|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.04|-0.84|0.0300
71139872|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0605|TWO_SIDED|95.0|-0.78|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||0.02|-0.78|0.0605
70948519|NCT05186311|141398060|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
71139873|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.2||0.0001|TWO_SIDED|95.0|-1.2|-0.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.40|-1.20|0.0001
71139874|NCT03192176|141778519|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.38|-0.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.56|-1.38|<0.0001
71139875|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1848|TWO_SIDED|95.0|-0.68|0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 10||0.13|-0.68|0.1848
71139876|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0321|TWO_SIDED|95.0|-0.84|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.04|-0.84|0.0321
71139877|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0025|TWO_SIDED|95.0|-1.01|-0.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.22|-1.01|0.0025
71139878|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0441|TWO_SIDED|95.0|-0.81|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.01|-0.81|0.0441
71139879|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0422|TWO_SIDED|95.0|-0.82|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.01|-0.82|0.0422
71139880|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.27|-0.45||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.45|-1.27|<0.0001
71139881|NCT03192176|141778519|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.44|-0.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.62|-1.44|<0.0001
71139882|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1464|TWO_SIDED|95.0|-0.71|0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||0.11|-0.71|0.1464
71139883|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0144|TWO_SIDED|95.0|-0.91|-0.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.10|-0.91|0.0144
71139884|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0013|TWO_SIDED|95.0|-1.06|-0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.26|-1.06|0.0013
71139885|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0596|TWO_SIDED|95.0|-0.8|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.02|-0.80|0.0596
71139886|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.036|TWO_SIDED|95.0|-0.85|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.03|-0.85|0.0360
71139887|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.21||0.0006|TWO_SIDED|95.0|-1.15|-0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.32|-1.15|0.0006
70865278|NCT02833350|141216292|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.92|2.92|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.92|-2.92|1.0000
70865279|NCT02833350|141216292|SUPERIORITY||Adjusted Difference|0.91||||0.5976|TWO_SIDED|95.0|-2.47|4.28|||Cochran-Mantel-Haenszel|||Week 2, Day 14||4.28|-2.47|0.5976
70865280|NCT02833350|141216292|SUPERIORITY||Adjusted Difference|-0.4||||0.8979|TWO_SIDED|95.0|-6.51|5.71|||Cochran-Mantel-Haenszel|||Week 4, Day 28||5.71|-6.51|0.8979
70865281|NCT02833350|141216292|SUPERIORITY||Adjusted Difference|-0.91||||0.5976|TWO_SIDED|95.0|-4.3|2.48|||Cochran-Mantel-Haenszel|||Week 4 Day 28||2.48|-4.30|0.5976
70865282|NCT02833350|141216292|SUPERIORITY||Adjusted Difference|0.91||||0.6669|TWO_SIDED|95.0|-3.23|5.05|||Cochran-Mantel-Haenszel|||Week 4, Day 28||5.05|-3.23|0.6669
70865283|NCT02833350|141216292|SUPERIORITY||Adjusted Difference|-1.6||||0.6309|TWO_SIDED|95.0|-8.13|4.93|||Cochran-Mantel-Haenszel|||Week 8, Day 56||4.93|-8.13|0.6309
70948520|NCT05186311|141398061|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
70948521|NCT03178344|141398092|EQUIVALENCE|ANOVA||||||0.7||||||P value threshold is 0.05|ANOVA|||||||0.70
71139888|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.21||0.0002|TWO_SIDED|95.0|-1.23|-0.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.39|-1.23|0.0002
70948522|NCT03178344|141398093|EQUIVALENCE|ANOVA||||||0.71||||||P value threshold is 0.05.|ANOVA|||||||0.71
70948523|NCT04560374|141398117|EQUIVALENCE|Power analysis was performed after the completion of the study. 98% power was obtained.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70865284|NCT02833350|141216292|SUPERIORITY||Adjusted Difference|1.83||||0.4473|TWO_SIDED|95.0|-2.9|6.56|||Cochran-Mantel-Haenszel|||Week 8, Day 56||6.56|-2.90|0.4473
70865285|NCT02833350|141216292|SUPERIORITY||Adjusted Difference|2.73||||0.3021|TWO_SIDED|95.0|-2.45|7.91|||Cochran-Mantel-Haenszel|||Week 8, Day 56||7.91|-2.45|0.3021
70865286|NCT02833350|141216292|SUPERIORITY||Adjusted Difference|-1.6||||0.7134|TWO_SIDED|95.0|-10.14|6.94|||Cochran-Mantel-Haenszel|||Week 12, Day 84||6.94|-10.14|0.7134
70865287|NCT02833350|141216292|SUPERIORITY||Adjusted Difference|3.7||||0.2635|TWO_SIDED|95.0|-2.79|10.19|||Cochran-Mantel-Haenszel|||Week 12, Day 84||10.19|-2.79|0.2635
70865288|NCT02833350|141216292|SUPERIORITY||Adjusted Difference|4.55||||0.1749|TWO_SIDED|95.0|-2.02|11.11|||Cochran-Mantel-Haenszel|||Week 12, Day 84||11.11|-2.02|0.1749
70865289|NCT02833350|141216292|SUPERIORITY||Adjusted Difference|2.05||||0.6588|TWO_SIDED|95.0|-7.07|11.18|||Cochran-Mantel-Haenszel|||Week 1, Day 7||11.18|-7.07|0.6588
70865290|NCT02833350|141216292|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 2 Day 14||8.31|-8.31|1.0000
70865291|NCT02833350|141216292|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 4, Day 28||8.31|-8.31|1.0000
70865292|NCT02833350|141216292|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 8, Day 56||8.31|-8.31|1.0000
70865293|NCT02833350|141216292|SUPERIORITY||Adjusted Difference|1.37||||0.7848|TWO_SIDED|95.0|-8.46|11.2|||Cochran-Mantel-Haenszel|||Week 12, Day 84||11.20|-8.46|0.7848
70865294|NCT02833350|141216293|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.28|6.28|||Cochran-Mantel-Haenszel|||Week 1, Day 7||6.28|-6.28|1.0000
70865295|NCT02833350|141216293|SUPERIORITY||Adjusted Difference|0.93||||0.5941|TWO_SIDED|95.0|-2.5|4.37|||Cochran-Mantel-Haenszel|||Week 1, Day 7||4.37|-2.50|0.5941
70865296|NCT02833350|141216293|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.93|2.93|||Cochran-Mantel-Haenszel|||Week 1, Day 7||2.93|-2.93|1.0000
70865297|NCT02833350|141216293|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.17|6.17|||Cochran-Mantel-Haenszel|||Week 2, Day 14||6.17|-6.17|1.0000
70865298|NCT02833350|141216293|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.95|2.95|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.95|-2.95|1.0000
70865299|NCT02833350|141216293|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.92|2.92|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.92|-2.92|1.0000
70865300|NCT02833350|141216293|SUPERIORITY||Adjusted Difference|-0.43||||0.8929|TWO_SIDED|95.0|-6.62|5.77|||Cochran-Mantel-Haenszel|||Week 4, Day 28||5.77|-6.62|0.8929
70865301|NCT02833350|141216293|SUPERIORITY||Adjusted Difference|-0.13||||0.9424|TWO_SIDED|95.0|-3.78|3.51|||Cochran-Mantel-Haenszel|||Week 4, Day 28||3.51|-3.78|0.9424
70865302|NCT02833350|141216293|SUPERIORITY||Adjusted Difference|-0.94||||0.5927|TWO_SIDED|95.0|-4.4|2.51|||Cochran-Mantel-Haenszel|||Week 4, Day 28||2.51|-4.40|0.5927
70865303|NCT02833350|141216293|SUPERIORITY||Adjusted Difference|-0.46||||0.8788|TWO_SIDED|95.0|-6.31|5.4|||Cochran-Mantel-Haenszel|||Week 8, Day 56||5.40|-6.31|0.8788
70948524|NCT03721172|141398122|SUPERIORITY||Adjusted difference|17.5|||<|0.0001|TWO_SIDED|95.0|12.2|22.8|||Cochran-Mantel-Haenszel|Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|2-sided 95% CIs based on the stratified Newcombe method. Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|||22.8|12.2|<0.0001
70948525|NCT03721172|141398123|SUPERIORITY||Adjusted difference|25.6|||<|0.0001|TWO_SIDED|95.0|19.1|32.1|||Cochran-Mantel-Haenszel|Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|2-sided 95% CIs based on the stratified Newcombe method. Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|||32.1|19.1|<0.0001
70948526|NCT03721172|141398124|SUPERIORITY||Least squares mean difference|-3.38|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-4.04|-2.73|||Mixed-effect model for repeated measures|||||-2.73|-4.04|<0.0001
71139889|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.3227|TWO_SIDED|95.0|-0.62|0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.21|-0.62|0.3227
71139890|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.022|TWO_SIDED|95.0|-0.89|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.07|-0.89|0.0220
71139891|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.038|TWO_SIDED|95.0|-0.84|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.02|-0.84|0.0380
71139892|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0067|TWO_SIDED|95.0|-0.6|-0.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.10|-0.60|0.0067
71139893|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1227|TWO_SIDED|95.0|-0.45|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMMRM|||Week 13||0.05|-0.45|0.1227
71139894|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0208|TWO_SIDED|95.0|-0.57|-0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.05|-0.57|0.0208
71139895|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.2396|TWO_SIDED|95.0|-0.41|0.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|LSMean difference|||Week 13||0.10|-0.41|0.2396
71139896|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0022|TWO_SIDED|95.0|-0.67|-0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.15|-0.67|0.0022
71139897|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0479|TWO_SIDED|95.0|-0.53|0.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.00|-0.53|0.0479
71139898|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.4152|TWO_SIDED|95.0|-0.35|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.15|-0.35|0.4152
70865304|NCT02833350|141216293|SUPERIORITY||Adjusted Difference|0.87||||0.6876|TWO_SIDED|95.0|-3.36|5.09|||Cochran-Mantel-Haenszel|||Week 8 Day 56||5.09|-3.36|0.6876
71139899|NCT03192176|141778519|SUPERIORITY||LSMean differencce|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0262|TWO_SIDED|95.0|-0.52|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.03|-0.52|0.0262
71139900|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.121|TWO_SIDED|95.0|-0.43|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.05|-0.43|0.1210
71139901|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0369|TWO_SIDED|95.0|-0.52|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.02|-0.52|0.0369
70865305|NCT02833350|141216293|SUPERIORITY||Adjusted Difference|0.97||||0.6656|TWO_SIDED|95.0|-3.42|5.35|||Cochran-Mantel-Haenszel|||Week 8, Day 56||5.35|-3.42|0.6656
70865306|NCT02833350|141216293|SUPERIORITY||Adjusted Difference|-0.46||||0.8787|TWO_SIDED|95.0|-6.34|5.42|||Cochran-Mantel-Haenszel|||Week 12 Day 84||5.42|-6.34|0.8787
70865307|NCT02833350|141216293|SUPERIORITY||Adjusted Difference|0.74||||0.7101|TWO_SIDED|95.0|-3.17|4.66|||Cochran-Mantel-Haenszel|||Week 12, Day 84||4.66|-3.17|0.7101
70865308|NCT02833350|141216293|SUPERIORITY||Adjusted Difference|3.2||||0.2425|TWO_SIDED|95.0|-2.16|8.55|||Cochran-Mantel-Haenszel|||Week 12, Day 84||8.55|-2.16|0.2425
70865309|NCT02833350|141216293|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.68|8.68|||Cochran-Mantel-Haenszel|||Week 1, Day 7||8.68|-8.68|1.0000
70865310|NCT02833350|141216293|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.39|8.39|||Cochran-Mantel-Haenszel|||Week 2 Day 14||8.39|-8.39|1.0000
70865311|NCT02833350|141216293|SUPERIORITY||Adjusted Difference|2.03||||0.6658|TWO_SIDED|95.0|-7.17|11.22|||Cochran-Mantel-Haenszel|||Week 4, Day 28||11.22|-7.17|0.6658
70865312|NCT02833350|141216293|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.77|8.77|||Cochran-Mantel-Haenszel|||Week 8, Day 56||8.77|-8.77|1.0000
70865313|NCT02833350|141216293|SUPERIORITY||Adjusted Difference|6.57||||0.2457|TWO_SIDED|95.0|-4.52|17.66|||Cochran-Mantel-Haenszel|||Week 12, Day 84||17.66|-4.52|0.2457
70865314|NCT02833350|141216294|SUPERIORITY||Adjusted Difference|-2.36||||0.496|TWO_SIDED|95.0|-6.73|2.02|||Cochran-Mantel-Haenszel|||Week 1, Day 7||2.02|-6.73|0.4960
70865315|NCT02833350|141216294|SUPERIORITY||Adjusted Difference|-2.18||||0.2736|TWO_SIDED|95.0|-5.34|0.98|||Cochran-Mantel-Haenszel|||Week 1, Day 7||0.98|-5.34|0.2736
70865316|NCT02833350|141216294|SUPERIORITY||Adjusted Difference|-3.08||||0.0608|TWO_SIDED|95.0|-6.26|0.1|||Cochran-Mantel-Haenszel|||Week 1, Day 7||0.10|-6.26|0.0608
70865317|NCT02833350|141216294|SUPERIORITY||Adjusted Difference|-1.25||||0.9237|TWO_SIDED|95.0|-6.02|3.52|||Cochran-Mantel-Haenszel|||Week 2, Day 14||3.52|-6.02|0.9237
70865318|NCT02833350|141216294|SUPERIORITY||Adjusted Difference|-3.14||||0.0893|TWO_SIDED|95.0|-6.6|0.33|||Cochran-Mantel-Haenszel|||Week 2, Day 14||0.33|-6.60|0.0893
70865319|NCT02833350|141216294|SUPERIORITY||Adjusted Difference|-4.07||||0.0138|TWO_SIDED|95.0|-7.51|-0.63|||Cochran-Mantel-Haenszel|||Week 2, Day 14||-0.63|-7.51|0.0138
70865320|NCT02833350|141216294|SUPERIORITY||Adjusted Difference|-3.22||||0.3358|TWO_SIDED|95.0|-8.24|1.8|||Cochran-Mantel-Haenszel|||Week 4, Day 28||1.80|-8.24|0.3358
70865321|NCT02833350|141216294|SUPERIORITY||Adjusted Difference|-4.57||||0.0078|TWO_SIDED|95.0|-8.2|-0.94|||Cochran-Mantel-Haenszel|||Week 4, Day 28||-0.94|-8.20|0.0078
70865322|NCT02833350|141216294|SUPERIORITY||Adjusted Difference|-4.68||||0.0059|TWO_SIDED|95.0|-8.3|-1.06|||Cochran-Mantel-Haenszel|||Week 4, Day 28||-1.06|-8.30|0.0059
70865323|NCT02833350|141216294|SUPERIORITY||Adjusted Difference|-2.29||||0.6503|TWO_SIDED|95.0|-7.39|2.8|||Cochran-Mantel-Haenszel|||Week 8, Day 56||2.80|-7.39|0.6503
70865324|NCT02833350|141216294|SUPERIORITY||Adjusted Difference|-3.12||||0.1282|TWO_SIDED|95.0|-6.84|0.59|||Cochran-Mantel-Haenszel|||Week 8, Day 56||0.59|-6.84|0.1282
70865325|NCT02833350|141216294|SUPERIORITY||Adjusted Difference|-2.94||||0.1675|TWO_SIDED|95.0|-6.65|0.78|||Cochran-Mantel-Haenszel|||Week 8, Day 56||0.78|-6.65|0.1675
70865326|NCT02833350|141216294|SUPERIORITY||Adjusted Difference|-2.94||||0.422|TWO_SIDED|95.0|-7.96|2.09|||Cochran-Mantel-Haenszel|||Week 12, Day 84||2.09|-7.96|0.4220
70865327|NCT02833350|141216294|SUPERIORITY||Adjusted Difference|-5.1||||0.0027|TWO_SIDED|95.0|-8.77|-1.42|||Cochran-Mantel-Haenszel|||Week 12, Day 84||-1.42|-8.77|0.0027
70865328|NCT02833350|141216294|SUPERIORITY||Adjusted Difference|-5.47||||0.0011|TWO_SIDED|95.0|-9.15|-1.78|||Cochran-Mantel-Haenszel|||Week 12, Day 84||-1.78|-9.15|0.0011
70865329|NCT02833350|141216294|SUPERIORITY||Adjusted Difference|3.21||||0.0455|TWO_SIDED|95.0|0.05|6.37|||Cochran-Mantel-Haenszel|||Week 1, Day 7||6.37|0.05|0.0455
70865330|NCT02833350|141216294|SUPERIORITY||Adjusted Difference|2.31||||0.2309|TWO_SIDED|95.0|-0.87|5.48|||Cochran-Mantel-Haenszel|||Week 1, Day 7||5.48|-0.87|0.2309
70865331|NCT02833350|141216294|SUPERIORITY||Adjusted Difference|3.27||||0.0698|TWO_SIDED|95.0|-0.18|6.72|||Cochran-Mantel-Haenszel|||Week 2, Day 14||6.72|-0.18|0.0698
70865332|NCT02833350|141216294|SUPERIORITY||Adjusted Difference|2.33||||0.2851|TWO_SIDED|95.0|-1.09|5.76|||Cochran-Mantel-Haenszel|||Week 2, Day 14||5.76|-1.09|0.2851
70865333|NCT02833350|141216294|SUPERIORITY||Adjusted Difference|4.29||||0.0131|TWO_SIDED|95.0|0.69|7.9|||Cochran-Mantel-Haenszel|||Week 4, Day 28||7.90|0.69|0.0131
70865334|NCT02833350|141216294|SUPERIORITY||Adjusted Difference|4.18||||0.0161|TWO_SIDED|95.0|0.59|7.78|||Cochran-Mantel-Haenszel|||Week 4, Day 28||7.78|0.59|0.0161
71139902|NCT03192176|141778519|SUPERIORITY||LSMean differencce|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.5855|TWO_SIDED|95.0|-0.32|0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.18|-0.32|0.5855
71139903|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0041|TWO_SIDED|95.0|-0.62|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.12|-0.62|0.0041
71139904|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.0614|TWO_SIDED|95.0|-0.5|0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.01|-0.50|0.0614
71139905|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.3391|TWO_SIDED|95.0|-0.36|0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.12|-0.36|0.3391
71139906|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.0515|TWO_SIDED|95.0|-0.49|0.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.00|-0.49|0.0515
71139907|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.0667|TWO_SIDED|95.0|-0.47|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.02|-0.47|0.0667
71139908|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0047|TWO_SIDED|95.0|-0.63|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||-0.12|-0.63|0.0047
71139909|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.513|TWO_SIDED|95.0|-0.34|0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.17|-0.34|0.5130
71139910|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13||0.0002|TWO_SIDED|95.0|-0.75|-0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||-0.23|-0.75|0.0002
71139911|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0126|TWO_SIDED|95.0|-0.6|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||-0.07|-0.60|0.0126
71139912|NCT03192176|141778519|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.3507|TWO_SIDED|95.0|-0.36|0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.13|-0.36|0.3507
71139913|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0098|TWO_SIDED|95.0|-0.6|-0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.08|-0.60|0.0098
71139914|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0048|TWO_SIDED|95.0|-0.63|-0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.11|-0.63|0.0048
71139915|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.8|-0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.28|-0.80|<0.0001
70865335|NCT02833350|141216294|SUPERIORITY||Adjusted Difference|3.85||||0.036|TWO_SIDED|95.0|0.18|7.51|||Cochran-Mantel-Haenszel|||Week 8, Day 56||7.51|0.18|0.0360
71139916|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.0|-0.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.47|-1.00|<0.0001
70865336|NCT02833350|141216294|SUPERIORITY||Adjusted Difference|4.04||||0.0252|TWO_SIDED|95.0|0.37|7.7|||Cochran-Mantel-Haenszel|||Week 8, Day 56||7.70|0.37|0.0252
71139917|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.6761|TWO_SIDED|95.0|-0.32|0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||0.21|-0.32|0.6761
71139918|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0188|TWO_SIDED|95.0|-0.57|-0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.05|-0.57|0.0188
70865337|NCT02833350|141216294|SUPERIORITY||Adjusted Difference|1.03||||0.9032|TWO_SIDED|95.0|-2.59|4.66|||Cochran-Mantel-Haenszel|||Week 12, Day 84||4.66|-2.59|0.9032
70865338|NCT02833350|141216294|SUPERIORITY||Adjusted Difference|0.66||||0.9791|TWO_SIDED|95.0|-2.97|4.3|||Cochran-Mantel-Haenszel|||Week 12, Day 84||4.30|-2.97|0.9791
71139919|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0067|TWO_SIDED|95.0|-0.61|-0.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.10|-0.61|0.0067
71139920|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0335|TWO_SIDED|95.0|-0.68|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.03|-0.68|0.0335
71139921|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17||0.0007|TWO_SIDED|95.0|-0.91|-0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.25|-0.91|0.0007
71139922|NCT03192176|141778520|SUPERIORITY||LSMean differencce|-0.8|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.14|-0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.48|-1.14|<0.0001
71139923|NCT03192176|141778520|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.41|-0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.74|-1.41|<0.0001
71139924|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.3227|TWO_SIDED|95.0|-0.5|0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||0.17|-0.50|0.3227
71139925|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0085|TWO_SIDED|95.0|-0.77|-0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.11|-0.77|0.0085
71139926|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17||0.0002|TWO_SIDED|95.0|-0.95|-0.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.30|-0.95|0.0002
71139927|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0102|TWO_SIDED|95.0|-0.87|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.12|-0.87|0.0102
71139928|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.15|-0.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.39|-1.15|<0.0001
71139929|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.29|-0.54||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.54|-1.29|<0.0001
71139930|NCT03192176|141778520|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.46|-0.68||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.68|-1.46|<0.0001
70865339|NCT02833350|141216294|SUPERIORITY||Adjusted Difference|-3.22||||0.0927|TWO_SIDED|95.0|-6.98|0.54|||Cochran-Mantel-Haenszel|||Week 1, Day 7||0.54|-6.98|0.0927
70865340|NCT02833350|141216294|SUPERIORITY||Adjusted Difference|-2.12||||0.3202|TWO_SIDED|95.0|-6.33|2.09|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.09|-6.33|0.3202
70865341|NCT02833350|141216294|SUPERIORITY||Adjusted Difference|-4.2||||0.0476|TWO_SIDED|95.0|-8.36|-0.04|||Cochran-Mantel-Haenszel|||Week 4, Day 28||-0.04|-8.36|0.0476
70865342|NCT02833350|141216294|SUPERIORITY||Adjusted Difference|-9.93|||<|0.0001|TWO_SIDED|95.0|-14.31|-5.55|||Cochran-Mantel-Haenszel|||Week 8, Day 54||-5.55|-14.31|<0.0001
71139931|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.074|TWO_SIDED|95.0|-0.73|0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||0.03|-0.73|0.0740
71139932|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.19||0.0024|TWO_SIDED|95.0|-0.97|-0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.21|-0.97|0.0024
71139933|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.17|-0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.41|-1.17|<0.0001
71139934|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1197|TWO_SIDED|95.0|-0.72|0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||0.08|-0.72|0.1197
71139935|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0046|TWO_SIDED|95.0|-0.98|-0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.18|-0.98|0.0046
70865343|NCT02833350|141216294|SUPERIORITY||Adjusted Difference|-8.23||||0.0003|TWO_SIDED|95.0|-12.56|-3.9|||Cochran-Mantel-Haenszel|||Week 12, Day 84||-3.90|-12.56|0.0003
70865344|NCT02833350|141216295|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 1, Day 7||6.06|-6.06|1.0000
70865345|NCT02833350|141216295|SUPERIORITY||Adjusted Difference|0.91||||0.5976|TWO_SIDED|95.0|-2.48|4.3|||Cochran-Mantel-Haenszel|||Week 1, Day 7||4.30|-2.48|0.5976
70865346|NCT02833350|141216295|SUPERIORITY||Adjusted Difference|0.91||||0.5976|TWO_SIDED|95.0|-2.47|4.28|||Cochran-Mantel-Haenszel|||Week 1, Day 7||4.28|-2.47|0.5976
70865347|NCT02833350|141216295|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 2, Day 14||6.06|-6.06|1.0000
70865348|NCT02833350|141216295|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.92|2.92|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.92|-2.92|1.0000
70865349|NCT02833350|141216295|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.91|2.91|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.91|-2.91|1.0000
70865350|NCT02833350|141216295|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 4, Day 28||6.06|-6.06|1.0000
70865351|NCT02833350|141216295|SUPERIORITY||Adjusted Difference|0.91||||0.5726|TWO_SIDED|95.0|-2.26|4.09|||Cochran-Mantel-Haenszel|||Week 4, Day 28||4.09|-2.26|0.5726
70865352|NCT02833350|141216295|SUPERIORITY||Adjusted Difference|0.91||||0.5976|TWO_SIDED|95.0|-2.47|4.28|||Cochran-Mantel-Haenszel|||Week 4, Day 28||4.28|-2.47|0.5976
71139936|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.28|-0.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.47|-1.28|<0.0001
70865353|NCT02833350|141216295|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 8, Day 56||6.06|-6.06|1.0000
71139937|NCT03192176|141778520|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.51|-0.69||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.69|-1.51|<0.0001
71139938|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0553|TWO_SIDED|95.0|-0.8|0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||0.01|-0.80|0.0553
71139939|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0823|TWO_SIDED|95.0|-0.76|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||0.05|-0.76|0.0823
71139940|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.006|TWO_SIDED|95.0|-0.96|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.16|-0.96|0.0060
71139941|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0374|TWO_SIDED|95.0|-0.83|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.03|-0.83|0.0374
71139942|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.21||0.0042|TWO_SIDED|95.0|-1.0|-0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.19|-1.00|0.0042
71139943|NCT03192176|141778520|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.38|-0.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.56|-1.38|<0.0001
71139944|NCT03192176|141778520|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.54|-0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.71|-1.54|<0.0001
71139945|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.071|TWO_SIDED|95.0|-0.79|0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||0.03|-0.79|0.0710
71139946|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.016|TWO_SIDED|95.0|-0.91|-0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.09|-0.91|0.0160
71139947|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.21||0.0003|TWO_SIDED|95.0|-1.15|-0.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.34|-1.15|0.0003
71139948|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1013|TWO_SIDED|95.0|-0.76|0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||0.07|-0.76|0.1013
70865354|NCT02833350|141216295|SUPERIORITY||Adjusted Difference|2.74||||0.1446|TWO_SIDED|95.0|-0.94|6.42|||Cochran-Mantel-Haenszel|||Week 8, Day 56||6.42|-0.94|0.1446
70865355|NCT02833350|141216295|SUPERIORITY||Adjusted Difference|5.45||||0.0286|TWO_SIDED|95.0|0.57|10.34|||Cochran-Mantel-Haenszel|||Week 8, Day 56||10.34|0.57|0.0286
70865356|NCT02833350|141216295|SUPERIORITY||Adjusted Difference|-0.4||||0.8979|TWO_SIDED|95.0|-6.51|5.71|||Cochran-Mantel-Haenszel|||Week 12, Day 84||5.71|-6.51|0.8979
71139949|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.21||0.0011|TWO_SIDED|95.0|-1.11|-0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.28|-1.11|0.0011
71139950|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.36|-0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.53|-1.36|<0.0001
71139951|NCT03192176|141778520|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.57|-0.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.72|-1.57|<0.0001
71139952|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0476|TWO_SIDED|95.0|-0.85|0.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.00|-0.85|0.0476
70948527|NCT03721172|141398125|SUPERIORITY||Least squares mean difference|-2.93|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-3.47|-2.39|||Mixed-effect model for repeated measures|||||-2.39|-3.47|<0.0001
71139953|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.022|TWO_SIDED|95.0|-0.9|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.07|-0.90|0.0220
71139954|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.21||0.0019|TWO_SIDED|95.0|-1.07|-0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.24|-1.07|0.0019
71139955|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1457|TWO_SIDED|95.0|-0.74|0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.11|-0.74|0.1457
71139956|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0284|TWO_SIDED|95.0|-0.91|-0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.05|-0.91|0.0284
71139957|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.22||0.0002|TWO_SIDED|95.0|-1.26|-0.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.39|-1.26|0.0002
71139958|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.36|-0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.48|-1.36|<0.0001
71139959|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.22||0.4223|TWO_SIDED|95.0|-0.61|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.26|-0.61|0.4223
70865357|NCT02833350|141216295|SUPERIORITY||Adjusted Difference|4.57||||0.0708|TWO_SIDED|95.0|-0.39|9.52|||Cochran-Mantel-Haenszel|||Week 12, Day 84||9.52|-0.39|0.0708
70865358|NCT02833350|141216295|SUPERIORITY||Adjusted Difference|5.45||||0.0478|TWO_SIDED|95.0|0.05|10.86|||Cochran-Mantel-Haenszel|||Week 12, Day 84||10.86|0.05|0.0478
70865359|NCT02833350|141216295|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 1, Day 7||8.31|-8.31|1.0000
70948528|NCT03721172|141398126|SUPERIORITY||Adjusted difference|38.0|||<|0.0001|TWO_SIDED|95.0|29.7|46.3|||Cochran-Mantel-Haenszel|Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|2-sided 95% CIs based on the stratified Newcombe method. Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|||46.3|29.7|<0.0001
71139960|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0442|TWO_SIDED|95.0|-0.87|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.01|-0.87|0.0442
70948529|NCT03721172|141398127|SUPERIORITY||Adjusted difference|24.7|||<|0.0001|TWO_SIDED|95.0|16.5|32.8|||Cochran-Mantel-Haenszel|Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|2-sided 95% CIs based on the stratified Newcombe method. Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|||32.8|16.5|<0.0001
70948530|NCT03721172|141398128|SUPERIORITY||Adjusted difference|27.4|||<|0.0001|TWO_SIDED|95.0|18.6|36.3|||Cochran-Mantel-Haenszel|Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|2-sided 95% CIs based on the stratified Newcombe method. Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|||36.3|18.6|<0.0001
71139961|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.22||0.0071|TWO_SIDED|95.0|-1.02|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.16|-1.02|0.0071
71139962|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0823|TWO_SIDED|95.0|-0.8|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.05|-0.80|0.0823
71139963|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0336|TWO_SIDED|95.0|-0.89|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.04|-0.89|0.0336
71139964|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.32|-0.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.46|-1.32|<0.0001
71139965|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.34|-0.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.47|-1.34|<0.0001
71139966|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.22||0.4819|TWO_SIDED|95.0|-0.59|0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.28|-0.59|0.4819
71139967|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0371|TWO_SIDED|95.0|-0.88|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.03|-0.88|0.0371
71139968|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0121|TWO_SIDED|95.0|-0.97|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.12|-0.97|0.0121
71139969|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0281|TWO_SIDED|95.0|-0.89|-0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.05|-0.89|0.0281
71139970|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0436|TWO_SIDED|95.0|-0.86|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.01|-0.86|0.0436
71139971|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.34|-0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.49|-1.34|<0.0001
70865360|NCT02833350|141216295|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 2, Day 14||8.31|-8.31|1.0000
71139972|NCT03192176|141778520|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.47|-0.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.60|-1.47|<0.0001
70865361|NCT02833350|141216295|SUPERIORITY||Adjusted Difference|2.05||||0.6564|TWO_SIDED|95.0|-7.0|11.11|||Cochran-Mantel-Haenszel|||Week 4, Day 28||11.11|-7.00|0.6564
71139973|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1488|TWO_SIDED|95.0|-0.75|0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 10||0.11|-0.75|0.1488
71139974|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0251|TWO_SIDED|95.0|-0.91|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.06|-0.91|0.0251
70948531|NCT03721172|141398129|SUPERIORITY||Least squares mean difference|-2.9|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-3.7|-2.1|||Mixed-effect model for repeated measures|||||-2.1|-3.7|<0.0001
70865362|NCT02833350|141216295|SUPERIORITY||Adjusted Difference|4.11||||0.3838|TWO_SIDED|95.0|-5.14|13.36|||Cochran-Mantel-Haenszel|||Week 8, Day 56||13.36|-5.14|0.3838
70865363|NCT02833350|141216295|SUPERIORITY||Adjusted Difference|0.68||||0.9009|TWO_SIDED|95.0|-10.1|11.47|||Cochran-Mantel-Haenszel|||Week 12, Day 84||11.47|-10.10|0.9009
70865364|NCT02833350|141216296|SUPERIORITY||Adjusted Difference|-2.36||||0.5455|TWO_SIDED|95.0|-7.0|2.27|||Cochran-Mantel-Haenszel|||Week 1, Day 7||2.27|-7.00|0.5455
70865365|NCT02833350|141216296|SUPERIORITY||Adjusted Difference|-1.97||||0.4114|TWO_SIDED|95.0|-5.3|1.36|||Cochran-Mantel-Haenszel|||Week 1, Day 7||1.36|-5.30|0.4114
70865366|NCT02833350|141216296|SUPERIORITY||Adjusted Difference|-2.62||||0.1739|TWO_SIDED|95.0|-5.97|0.72|||Cochran-Mantel-Haenszel|||Week 1, Day 7||0.72|-5.97|0.1739
70865367|NCT02833350|141216296|SUPERIORITY||Adjusted Difference|-0.94||||0.9761|TWO_SIDED|95.0|-5.93|4.06|||Cochran-Mantel-Haenszel|||Week 2, Week 14||4.06|-5.93|0.9761
70865368|NCT02833350|141216296|SUPERIORITY||Adjusted Difference|-3.18||||0.0998|TWO_SIDED|95.0|-6.78|0.41|||Cochran-Mantel-Haenszel|||Week 2, Week 14||0.41|-6.78|0.0998
70865369|NCT02833350|141216296|SUPERIORITY||Adjusted Difference|-3.97||||0.0239|TWO_SIDED|95.0|-7.54|-0.39|||Cochran-Mantel-Haenszel|||Week 2, Week 14||-0.39|-7.54|0.0239
70865370|NCT02833350|141216296|SUPERIORITY||Adjusted Difference|-3.98||||0.2018|TWO_SIDED|95.0|-9.25|1.3|||Cochran-Mantel-Haenszel|||Week 4, Day 28||1.30|-9.25|0.2018
70865371|NCT02833350|141216296|SUPERIORITY||Adjusted Difference|-5.67||||0.0011|TWO_SIDED|95.0|-9.48|-1.87|||Cochran-Mantel-Haenszel|||Week 4, Day 28||-1.87|-9.48|0.0011
70865372|NCT02833350|141216296|SUPERIORITY||Adjusted Difference|-5.27||||0.0026|TWO_SIDED|95.0|-9.06|-1.48|||Cochran-Mantel-Haenszel|||Week 4, Day 28||-1.48|-9.06|0.0026
70865373|NCT02833350|141216296|SUPERIORITY||Adjusted Difference|-2.47||||0.6336|TWO_SIDED|95.0|-7.84|2.9|||Cochran-Mantel-Haenszel|||Week 8, Day 56||2.90|-7.84|0.6336
70865374|NCT02833350|141216296|SUPERIORITY||Adjusted Difference|-3.49||||0.095|TWO_SIDED|95.0|-7.38|0.41|||Cochran-Mantel-Haenszel|||Week 8, Day 56||0.41|-7.38|0.0950
70865375|NCT02833350|141216296|SUPERIORITY||Adjusted Difference|-3.18||||0.1451|TWO_SIDED|95.0|-7.06|0.71|||Cochran-Mantel-Haenszel|||Week 8, Day 56||0.71|-7.06|0.1451
70865376|NCT02833350|141216296|SUPERIORITY||Adjusted Difference|-3.28||||0.3434|TWO_SIDED|95.0|-8.43|1.87|||Cochran-Mantel-Haenszel|||Week 12, Day 84||1.87|-8.43|0.3434
70865377|NCT02833350|141216296|SUPERIORITY||Adjusted Difference|-5.45||||0.0016|TWO_SIDED|95.0|-9.23|-1.68|||Cochran-Mantel-Haenszel|||Week 12, Day 84||-1.68|-9.23|0.0016
70865378|NCT02833350|141216296|SUPERIORITY||Adjusted Difference|-5.88||||0.0006|TWO_SIDED|95.0|-9.65|-2.1|||Cochran-Mantel-Haenszel|||Week 12, Day 84||-2.10|-9.65|0.0006
70865379|NCT02833350|141216296|SUPERIORITY||Adjusted Difference|4.64||||0.0025|TWO_SIDED|95.0|1.31|7.96|||Cochran-Mantel-Haenszel|||Week 1, Day 7||7.96|1.31|0.0025
70865380|NCT02833350|141216296|SUPERIORITY||Adjusted Difference|3.98||||0.0129|TWO_SIDED|95.0|0.64|7.32|||Cochran-Mantel-Haenszel|||Week 1, Day 7||7.32|0.64|0.0129
70865381|NCT02833350|141216296|SUPERIORITY||Adjusted Difference|4.04||||0.0206|TWO_SIDED|95.0|0.46|7.62|||Cochran-Mantel-Haenszel|||Week 2, Day 14||7.62|0.46|0.0206
70865382|NCT02833350|141216296|SUPERIORITY||Adjusted Difference|3.26||||0.0841|TWO_SIDED|95.0|-0.3|6.82|||Cochran-Mantel-Haenszel|||Week 2, Day 14||6.82|-0.30|0.0841
70865383|NCT02833350|141216296|SUPERIORITY||Adjusted Difference|4.67||||0.0088|TWO_SIDED|95.0|0.91|8.42|||Cochran-Mantel-Haenszel|||Week 4, Day 28||8.42|0.91|0.0088
70865384|NCT02833350|141216296|SUPERIORITY||Adjusted Difference|5.07||||0.0034|TWO_SIDED|95.0|1.34|8.81|||Cochran-Mantel-Haenszel|||Week 4, Day 28||8.81|1.34|0.0034
71139975|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.22||0.0027|TWO_SIDED|95.0|-1.08|-0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.23|-1.08|0.0027
71139976|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1053|TWO_SIDED|95.0|-0.77|0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||0.07|-0.77|0.1053
71139977|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0304|TWO_SIDED|95.0|-0.9|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.04|-0.90|0.0304
71139978|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.33|-0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.43|-1.33|<0.0001
70865385|NCT02833350|141216296|SUPERIORITY||Adjusted Difference|4.55||||0.0138|TWO_SIDED|95.0|0.71|8.39|||Cochran-Mantel-Haenszel|||Week 8, Day 56||8.39|0.71|0.0138
70865386|NCT02833350|141216296|SUPERIORITY||Adjusted Difference|4.85||||0.0073|TWO_SIDED|95.0|1.02|8.69|||Cochran-Mantel-Haenszel|||Week 8, Day 56||8.69|1.02|0.0073
70865387|NCT02833350|141216296|SUPERIORITY||Adjusted Difference|1.29||||0.8284|TWO_SIDED|95.0|-2.46|5.03|||Cochran-Mantel-Haenszel|||Week 12, Day 84||5.03|-2.46|0.8284
70865388|NCT02833350|141216296|SUPERIORITY||Adjusted Difference|0.86||||0.9525|TWO_SIDED|95.0|-2.88|4.6|||Cochran-Mantel-Haenszel|||Week 12, Day 84||4.60|-2.88|0.9525
70865389|NCT02833350|141216296|SUPERIORITY||Adjusted Difference|-3.22||||0.0856|TWO_SIDED|95.0|-6.91|0.46|||Cochran-Mantel-Haenszel|||Week 1, Day 7||0.46|-6.91|0.0856
70865390|NCT02833350|141216296|SUPERIORITY||Adjusted Difference|-2.08||||0.3374|TWO_SIDED|95.0|-6.36|2.2|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.20|-6.36|0.3374
70865391|NCT02833350|141216296|SUPERIORITY||Adjusted Difference|-4.24||||0.0534|TWO_SIDED|95.0|-8.53|0.06|||Cochran-Mantel-Haenszel|||Week 4, Day 28||0.06|-8.53|0.0534
70865392|NCT02833350|141216296|SUPERIORITY||Adjusted Difference|-10.8|||<|0.0001|TWO_SIDED|95.0|-15.33|-6.32|||Cochran-Mantel-Haenszel|||Week 8, Day 56||-6.32|-15.33|<0.0001
70865393|NCT02833350|141216296|SUPERIORITY||Adjusted Difference|-9.22|||<|0.0001|TWO_SIDED|95.0|-13.63|-4.81|||Cochran-Mantel-Haenszel|||Week 12, Day 84||-4.81|-13.63|<0.0001
70865394|NCT02833350|141216297|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 1, Day 7||6.06|-6.06|1.0000
70865395|NCT02833350|141216297|SUPERIORITY||Adjusted Difference|0.91||||0.5976|TWO_SIDED|95.0|-2.48|4.3|||Cochran-Mantel-Haenszel|||Week 1, Day 7||4.30|-2.48|0.5976
70865396|NCT02833350|141216297|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.91|2.91|||Cochran-Mantel-Haenszel|||Week 1, Day 7||2.91|-2.91|1.0000
70865397|NCT02833350|141216297|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 2, Day 14||6.06|-6.06|1.0000
70865398|NCT02833350|141216297|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.92|2.92|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.92|-2.92|1.0000
70865399|NCT02833350|141216297|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.91|2.91|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.91|-2.91|1.0000
70865400|NCT02833350|141216297|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 4, Day 28||6.06|-6.06|1.0000
70865401|NCT02833350|141216297|SUPERIORITY||Adjusted Difference|0.91||||0.5726|TWO_SIDED|95.0|-2.26|4.09|||Cochran-Mantel-Haenszel|||Week 4, Day 28||4.09|-2.26|0.5726
70865402|NCT02833350|141216297|SUPERIORITY||Mean Difference (Net)|0.91||||0.5976|TWO_SIDED|95.0|-2.47|4.28|||Cochran-Mantel-Haenszel|||Week 4, Day 28||4.28|-2.47|0.5976
70865403|NCT02833350|141216297|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 8, Day 56||6.06|-6.06|1.0000
70865404|NCT02833350|141216297|SUPERIORITY||Adjusted Difference|2.74||||0.1446|TWO_SIDED|95.0|-0.94|6.42|||Cochran-Mantel-Haenszel|||Week 8, Day 56||6.42|-0.94|0.1446
70865405|NCT02833350|141216297|SUPERIORITY||Adjusted Difference|3.64||||0.105|TWO_SIDED|95.0|-0.76|8.03|||Cochran-Mantel-Haenszel|||Week 8, Day 56||8.03|-0.76|0.1050
70865406|NCT02833350|141216297|SUPERIORITY||Adjusted Difference|-0.4||||0.8979|TWO_SIDED|95.0|-6.51|5.71|||Cochran-Mantel-Haenszel|||Week 12, Day 84||5.71|-6.51|0.8979
70865407|NCT02833350|141216297|SUPERIORITY||Adjusted Difference|3.65||||0.127|TWO_SIDED|95.0|-1.04|8.35|||Cochran-Mantel-Haenszel|||Week 12, Day 84||8.35|-1.04|0.1270
70865408|NCT02833350|141216297|SUPERIORITY||Adjusted Difference|5.45||||0.0501|TWO_SIDED|95.0|0.0|10.91|||Cochran-Mantel-Haenszel|||Week 12, Day 84||10.91|-0.00|0.0501
70865409|NCT02833350|141216297|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 1, Day 7||8.31|-8.31|1.0000
70865410|NCT02833350|141216297|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 2, Day 14||8.31|-8.31|1.0000
70865411|NCT02833350|141216297|SUPERIORITY||Adjusted Difference|2.05||||0.6564|TWO_SIDED|95.0|-7.0|11.11|||Cochran-Mantel-Haenszel|||Week 4, Day 28||11.11|-7.00|0.6564
70865412|NCT02833350|141216297|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 8, Day 56||8.31|-8.31|1.0000
70865413|NCT02833350|141216297|SUPERIORITY||Adjusted Difference|0.68||||0.9051|TWO_SIDED|95.0|-10.58|11.95|||Cochran-Mantel-Haenszel|||Week 12, Day 84||11.95|-10.58|0.9051
70865414|NCT04269707|141216317|NON_INFERIORITY|Change in hemoglobin from baseline to day 35 was assessed using paired t-tests (two-sided test, alpha = 0.05).|Mean Difference (Final Values)|0.7||||0.1711|TWO_SIDED|95.0|-0.4|1.8|||t-test, 2 sided|||||1.80|-0.40|0.1711
70865415|NCT02038881|141216348|OTHER||GMT Ratio (Group 1 / Group 2) at Week 4|0.851|||||TWO_SIDED|95.0|0.258|2.8||||||||2.800|0.258|
70865416|NCT02038881|141216348|OTHER||GMT Ratio (Group 1 / Group 2) at Week 6|0.653|||||TWO_SIDED|95.0|0.319|1.333||||||||1.333|0.319|
70865417|NCT02038881|141216348|OTHER||GMT Ratio (Group 1 / Group 2) at Week 30|1.126|||||TWO_SIDED|95.0|0.291|4.352||||||||4.352|0.291|
70865418|NCT02038881|141216348|OTHER||GMT Ratio (Group 1 / Group 2) at Week 56|0.916|||||TWO_SIDED|95.0|0.22|3.819||||||||3.819|0.220|
70865419|NCT02038881|141216348|OTHER||GMT Ratio (Group 3 / Group 1) at Week 4|1.045|||||TWO_SIDED|95.0|0.292|3.741||||||||3.741|0.292|
70865420|NCT02038881|141216348|OTHER||GMT Ratio (Group 3 / Group 1) at Week 6|1.315|||||TWO_SIDED|95.0|0.598|2.892||||||||2.892|0.598|
70865421|NCT02038881|141216349|OTHER||GMT Ratio (Group 1+3 [pooled] / Group 2)|0.762|||||TWO_SIDED|95.0|0.385|1.507||||||||1.507|0.385|
70865422|NCT02038881|141216350|OTHER||GMT Ratio (Group 1 [W6]/ Group 3 [W14)|0.347|||||TWO_SIDED|95.0|0.2|0.603||||||||0.603|0.200|
70865423|NCT02038881|141216350|OTHER||GMT ratio (Group 2 [W6]/ Group 3 [W14])|0.532|||||TWO_SIDED|95.0|0.285|0.992||||||||0.992|0.285|
70865424|NCT02038881|141216351|OTHER||GMT Ratio (Group 3 [W38]/ Group 1 [W30])|4.138|||||TWO_SIDED|95.0|1.241|13.793||||||||13.793|1.241|
70865425|NCT02038881|141216351|OTHER||GMT Ratio (Group 3 [W64]/ Group 1 [W56])|4.608|||||TWO_SIDED|95.0|1.365|15.558||||||||15.558|1.365|
70865426|NCT02038881|141216351|OTHER||GMT Ratio (Group 2 [W30]/ Group 3 [W38])|0.215|||||TWO_SIDED|95.0|0.066|0.699||||||||0.699|0.066|
70865427|NCT02038881|141216351|OTHER||GMT Ratio (Group 2 [W56]/ Group 3 [W64])|0.237|||||TWO_SIDED|95.0|0.072|0.782||||||||0.782|0.072|
70865428|NCT02038881|141216352|OTHER||GMT Ratio (Group 1 / Group 2) at Week 4|0.823|||||TWO_SIDED|95.0|0.333|2.038||||||||2.038|0.333|
70865429|NCT02038881|141216352|OTHER||GMT Ratio (Group 1 / Group 2) at Week 6|0.787|||||TWO_SIDED|95.0|0.41|1.508||||||||1.508|0.410|
71139979|NCT03192176|141778520|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.49|-0.61||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.61|-1.49|<0.0001
70865430|NCT02038881|141216352|OTHER||GMT Ratio (Group 1 / Group 2) at Week 30|0.535|||||TWO_SIDED|95.0|0.187|1.536||||||||1.536|0.187|
71139980|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0873|TWO_SIDED|95.0|-0.81|0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||0.06|-0.81|0.0873
71139981|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0124|TWO_SIDED|95.0|-0.97|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.12|-0.97|0.0124
71139982|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.22||0.0014|TWO_SIDED|95.0|-1.12|-0.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.27|-1.12|0.0014
71139983|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.0479|TWO_SIDED|95.0|-0.68|0.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.00|-0.68|0.0479
71139984|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.2342|TWO_SIDED|95.0|-0.54|0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMMRM|||Week 13||0.13|-0.54|0.2342
71139985|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.007|TWO_SIDED|95.0|-0.84|-0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.13|-0.84|0.0070
71139986|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.4291|TWO_SIDED|95.0|-0.49|0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|LSMean difference|||Week 13||0.21|-0.49|0.4291
71139987|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.0076|TWO_SIDED|95.0|-0.83|-0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.13|-0.83|0.0076
71139988|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.1506|TWO_SIDED|95.0|-0.62|0.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.10|-0.62|0.1506
71139989|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.5479|TWO_SIDED|95.0|-0.44|0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.24|-0.44|0.5479
70865431|NCT02038881|141216352|OTHER||GMT Ratio (Group 1 / Group 2) at Week 56|0.59|||||TWO_SIDED|95.0|0.203|1.716||||||||1.716|0.203|
70865432|NCT02038881|141216352|OTHER||GMT Ratio (Group 3 / Group 1) at Week 4|2.557|||||TWO_SIDED|95.0|0.972|6.731||||||||6.731|0.972|
70865433|NCT02038881|141216352|OTHER||GMT Ratio (Group 3 / Group 1) at Week 6|1.215|||||TWO_SIDED|95.0|0.612|2.412||||||||2.412|0.612|
71139990|NCT03192176|141778520|SUPERIORITY||LSMean differencce|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.1427|TWO_SIDED|95.0|-0.57|0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.08|-0.57|0.1427
71139991|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.1498|TWO_SIDED|95.0|-0.56|0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.09|-0.56|0.1498
71139992|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0103|TWO_SIDED|95.0|-0.79|-0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.11|-0.79|0.0103
70865434|NCT02038881|141216353|OTHER||GMT Ratio (Group 1+3 [pooled] / Group 2)|0.878|||||TWO_SIDED|95.0|0.48|1.606||||||||1.606|0.480|
70865435|NCT02038881|141216354|OTHER||GMT ratio (Group 1 [W6]/ Group 3 [W14)|0.281|||||TWO_SIDED|95.0|0.146|0.542||||||||0.542|0.146|
70865436|NCT02038881|141216354|OTHER||GMT ratio (Group 2 [W6]/ Group 3 [W14])|0.357|||||TWO_SIDED|95.0|0.178|0.718||||||||0.718|0.178|
70865437|NCT02038881|141216355|OTHER||GMT Ratio (Group 3 [W38]/ Group 1 [W30])|6.727|||||TWO_SIDED|95.0|2.493|18.15||||||||18.150|2.493|
70865438|NCT02038881|141216355|OTHER||GMT Ratio (Group 3 [W64]/ Group 1 [W56])|7.275|||||TWO_SIDED|95.0|2.693|19.649||||||||19.649|2.693|
70865439|NCT02038881|141216355|OTHER||GMT Ratio (Group 2 [W30]/ Group 3 [W38])|0.278|||||TWO_SIDED|95.0|0.115|0.672||||||||0.672|0.115|
70865440|NCT02038881|141216355|OTHER||GMT Ratio (Group 2 [W56]/ Group 3 [W64])|0.233|||||TWO_SIDED|95.0|0.1|0.541||||||||0.541|0.100|
70865441|NCT02038881|141216356|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 4|-7.6|||||TWO_SIDED|95.0|-34.1|17.9||||||||17.9|-34.1|
70865442|NCT02038881|141216356|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 6|0.0|||||TWO_SIDED|95.0|-16.8|16.3||||||||16.3|-16.8|
70865443|NCT02038881|141216356|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 30|5.1|||||TWO_SIDED|95.0|-24.5|32.6||||||||32.6|-24.5|
70865444|NCT02038881|141216356|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 56|-1.5|||||TWO_SIDED|95.0|-31.5|29.2||||||||29.2|-31.5|
70865445|NCT02038881|141216356|OTHER||Diff in SC rate (Gr 3 - Gr 1) at Week 4|-5.8|||||TWO_SIDED|95.0|-32.8|22.2||||||||22.2|-32.8|
70865446|NCT02038881|141216356|OTHER||Diff in SC rate (Gr 3 - Gr 1) at Week 6|-7.7|||||TWO_SIDED|95.0|-25.1|10.1||||||||10.1|-25.1|
70865447|NCT02038881|141216357|OTHER||Difference in seroconversion rates (%)|-4.3|||||TWO_SIDED|95.0|-15.2|11.6||||||||11.6|-15.2|
70865448|NCT02038881|141216358|OTHER||Diff in SC rate (Gr 1 [W6] - Gr 3 [W14])|0.0|||||TWO_SIDED|95.0|-17.1|13.4||||||||13.4|-17.1|
70865449|NCT02038881|141216358|OTHER||Diff in SC rate (Gr 2 [W6] - Gr 3 [W14])|0.0|||||TWO_SIDED|95.0|-16.2|13.4||||||||13.4|-16.2|
70865450|NCT02038881|141216359|OTHER||Diff in SC rate (Gr3 [W38] - Gr1 [W30])|5.6|||||TWO_SIDED|95.0|-19.6|33.0||||||||33.0|-19.6|
70865451|NCT02038881|141216359|OTHER||Diff in SC rate (Gr3 [W64] - Gr1 [W56])|16.7|||||TWO_SIDED|95.0|-11.0|44.4||||||||44.4|-11.0|
70865452|NCT02038881|141216359|OTHER||Diff in SC rate (Gr2 [W30] - Gr3 [W38])|-10.6|||||TWO_SIDED|95.0|-35.6|14.3||||||||14.3|-35.6|
70865453|NCT02038881|141216359|OTHER||Diff in SC rate (Gr2 [W56] - Gr3 [W64])|-15.2|||||TWO_SIDED|95.0|-40.5|10.5||||||||10.5|-40.5|
70865454|NCT02038881|141216360|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 4|-9.6|||||TWO_SIDED|95.0|-38.4|20.3||||||||20.3|-38.4|
70865455|NCT02038881|141216360|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 6|0.0|||||TWO_SIDED|95.0|-16.8|16.3||||||||16.3|-16.8|
70865456|NCT02038881|141216360|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 30|-9.6|||||TWO_SIDED|95.0|-38.4|17.6||||||||17.6|-38.4|
70865457|NCT02038881|141216360|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 56|-6.1|||||TWO_SIDED|95.0|-35.6|23.7||||||||23.7|-35.6|
70865458|NCT02038881|141216360|OTHER||Diff in SC rate (Gr 3 - Gr 1) at Week 4|20.8|||||TWO_SIDED|95.0|-7.7|47.8||||||||47.8|-7.7|
70865459|NCT02038881|141216360|OTHER||Diff in SC rate (Gr 3 - Gr 1) at Week 6|-3.8|||||TWO_SIDED|95.0|-20.5|13.4||||||||13.4|-20.5|
70865460|NCT02038881|141216361|OTHER||Difference in seroconversion rates (%)|-2.2|||||TWO_SIDED|95.0|-12.0|13.2||||||||13.2|-12.0|
70865461|NCT02038881|141216362|OTHER||Diff in SC rate (Gr 1 [W6] - Gr 3 [W14])|0.0|||||TWO_SIDED|95.0|-17.1|13.4||||||||13.4|-17.1|
70865462|NCT02038881|141216362|OTHER||Diff in SC rate (Gr 2 [W6] - Gr 3 [W14])|0.0|||||TWO_SIDED|95.0|-16.2|13.4||||||||13.4|-16.2|
70865463|NCT02038881|141216363|OTHER||Diff in SC rate (Gr3 [W38] - Gr1 [W30])|19.4|||||TWO_SIDED|95.0|-4.5|45.8||||||||45.8|-4.5|
70865464|NCT02038881|141216363|OTHER||Diff in SC rate (Gr3 [W64] - Gr1 [W56])|29.2|||||TWO_SIDED|95.0|5.8|55.4||||||||55.4|5.8|
70865465|NCT02038881|141216363|OTHER||Diff in SC rate (Gr2 [W30] - Gr3 [W38])|-9.8|||||TWO_SIDED|95.0|-33.0|11.7||||||||11.7|-33.0|
70865466|NCT02038881|141216363|OTHER||Diff in SC rate (Gr2 [W56] - Gr3 [W64])|-23.1|||||TWO_SIDED|95.0|-46.7|-1.0||||||||-1.0|-46.7|
70865467|NCT00850070|141216375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|||<|0.35|||||||Chi-squared||Estimated value comparison was active treatment minus placebo.|Chi-square analyses were used to assess CGI-I scores. There were no transformations.||||<.35
71139993|NCT03192176|141778520|SUPERIORITY||LSMean differencce|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.8984|TWO_SIDED|95.0|-0.36|0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.32|-0.36|0.8984
70865468|NCT00850070|141216376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|||<|0.06|||||||Chi-squared|||||||<0.06
70865469|NCT00850070|141216382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.9||0.05|||||||Mixed Models Analysis|||||||0.05
70865470|NCT05047770|141216385|NON_INFERIORITY|The non-inferiority was to be concluded if the upper limit (UL) of the 95% confidence interval (CI) of the adjusted GMC ratio between HZ/suSeq group and HZ/suCoAd group for anti-gE antibody concentration was below (\<) 1.5.|GMC Ratio|1.01|||||TWO_SIDED|95.0|0.89|1.13|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 2 doses of HZ/su vaccine when the first dose of HZ/su vaccine was co-administered with the mRNA-1273 booster dose compared to HZ/su vaccine administered alone, in terms of anti-gE GMCs, at 1 month post-dose 2 of HZ/su vaccine administration (Week 14 for HZ/suSeq group and Week 12 for HZ/suCoAd group).||1.13|0.89|
70865471|NCT05047770|141216386|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the adjusted GMC ratio between HZ/suSeq group and HZ/suCoAd group for anti-S protein antibody concentration was \<1.5.|GMC Ratio|1.09|||||TWO_SIDED|95.0|0.9|1.32|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of mRNA-1273 booster when the first dose of HZ/su vaccine was co-administered with the mRNA-1273 booster dose compared to mRNA-1273 booster dose administered alone, in terms of anti-S protein GMCs, at 1 month post-mRNA-1273 booster dose administration (at Week 4 for both HZ/suSeq and HZ/suCoAd groups).||1.32|0.90|
70865472|NCT05047770|141216387|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the adjusted GMT ratio between FluD-QIVSeq group and FluD-QIVCoAd group for anti-HI antibody titer was \<1.5 for the A/H1N1 influenza strain.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.89|1.18|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of anti-HI GMTs against the A/H1N1 influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||1.18|0.89|
70865473|NCT05047770|141216387|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the adjusted GMT ratio between FluD-QIVSeq group and FluD-QIVCoAd group for anti-HI antibody titer was \<1.5 for the A/H3N2 influenza strain.|GMT Ratio|0.93|||||TWO_SIDED|95.0|0.82|1.05|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of anti-HI GMTs against the A/H3N2 influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||1.05|0.82|
70865474|NCT05047770|141216387|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the adjusted GMT ratio between FluD-QIVSeq group and FluD-QIVCoAd group for anti-HI antibody titer was \<1.5 for the B/Victoria lineage influenza strain.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.89|1.14|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of anti-HI GMTs against the B/Victoria lineage influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||1.14|0.89|
70865475|NCT05047770|141216387|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the adjusted GMT ratio between FluD-QIVSeq group and FluD-QIVCoAd group for anti-HI antibody titer was \<1.5 for the B/Yamagata lineage influenza strain.|GMT Ratio|1.04|||||TWO_SIDED|95.0|0.93|1.17|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of anti-HI GMTs against the B/Yamagata lineage influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||1.17|0.93|
70865476|NCT05047770|141216388|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the adjusted GMC ratio between FluD-QIVSeq group and FluD-QIVCoAd group for anti-S antibody concentration was \<1.5.|GMC Ratio|0.98|||||TWO_SIDED|95.0|0.84|1.13|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of mRNA-1273 booster when co-administered with Flu D-QIV vaccine compared to mRNA-1273 booster dose administered alone in terms of anti-S protein GMCs, at 1 month post-mRNA-1273 booster dose administration (at Week 4 for both FluD-QIVSeq and FluD-QIVCoAd groups).||1.13|0.84|
70872204|NCT01727297|141229672|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.56|TWO_SIDED|95.0|0.77|1.61||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of being male on a patient's risk of developing AF.|The null hypothesis was that gender did not influence a patient's risk of experiencing AF (it's coefficient for being male in a Cox proportional hazards model was 0).||1.61|0.77|0.56
70865477|NCT05047770|141216389|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the difference in percentage of participants seroconverted for anti-HI antibodies against the A/H1N1 influenza strain between FluD-QIVSeq group and FluD-QIVCoAd group was \< 10%.|Difference in percentage|0.6|||||TWO_SIDED|95.0|-5.1|6.4|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of percentage of participants seroconverted for anti-HI antibodies against the A/H1N1 influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||6.4|-5.1|
70865478|NCT05047770|141216389|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the difference in percentage of participants seroconverted for anti-HI antibodies against the A/H3N2 influenza strain between FluD-QIVSeq group and FluD-QIVCoAd group was \< 10%.|Difference in percentage|-1.3|||||TWO_SIDED|95.0|-7.8|5.2|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of percentage of participants seroconverted for anti-HI antibodies against the A/H3N2 influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||5.2|-7.8|
70948532|NCT02402322|141398172|NON_INFERIORITY_OR_EQUIVALENCE|In the preliminary analysis, we studied the possible group differences in demographic data and pretreatment measures with chi-square tests and analysis of variance (ANOVA).||||||0.05|TWO_SIDED||||||ANOVA|||The participants' pre- and posttreatment scores were studied with repeated measures ANOVA. Within- and between-group effect sizes were calculated using the pooled standard deviation, Cohen's d.||||0.05
70948533|NCT02472145|141398195|SUPERIORITY||Odds Ratio (OR)|1.5||||0.4747|TWO_SIDED|95.0|0.8|2.8|||Chi-squared|||Statistical Analysis 1||2.8|0.8|0.4747
70948534|NCT02472145|141398196|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.7817|TWO_SIDED|95.0|0.79|1.37|||Log Rank|||Statistical Analysis 1||1.37|0.79|0.7817
70948535|NCT00409409|141398227|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANCOVA|||||||0.0010
71139994|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0095|TWO_SIDED|95.0|-0.79|-0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.11|-0.79|0.0095
71139995|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.137|TWO_SIDED|95.0|-0.6|0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.08|-0.60|0.1370
71139996|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.4223|TWO_SIDED|95.0|-0.46|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.19|-0.46|0.4223
71139997|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.3265|TWO_SIDED|95.0|-0.5|0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.17|-0.50|0.3265
71139998|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.0852|TWO_SIDED|95.0|-0.62|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.04|-0.62|0.0852
71139999|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.18||0.0021|TWO_SIDED|95.0|-0.91|-0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||-0.21|-0.91|0.0021
71140000|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.5717|TWO_SIDED|95.0|-0.45|0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.25|-0.45|0.5717
71140001|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.0084|TWO_SIDED|95.0|-0.82|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||-0.12|-0.82|0.0084
71140002|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0277|TWO_SIDED|95.0|-0.75|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||-0.04|-0.75|0.0277
71140003|NCT03192176|141778520|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.4627|TWO_SIDED|95.0|-0.46|0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.21|-0.46|0.4627
71140004|NCT03192176|141778521|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|1.94||0.0142|TWO_SIDED|95.0|-8.62|-0.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.97|-8.62|0.0142
71140005|NCT03192176|141778521|SUPERIORITY||LSMean difference|-7.9|STANDARD_ERROR_OF_MEAN|1.95|<|0.0001|TWO_SIDED|95.0|-11.73|-4.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-4.05|-11.73|<0.0001
70865479|NCT05047770|141216389|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the difference in percentage of participants seroconverted for anti-HI antibodies against the B/Victoria lineage influenza strain between FluD-QIVSeq group and FluD-QIVCoAd group was \< 10%.|Difference in percentage|0.1|||||TWO_SIDED|95.0|-5.8|5.9|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of percentage of participants seroconverted for anti-HI antibodies against the B/Victoria lineage influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||5.9|-5.8|
71140006|NCT03192176|141778521|SUPERIORITY||LSMean difference|-9.1|STANDARD_ERROR_OF_MEAN|1.95|<|0.0001|TWO_SIDED|95.0|-12.98|-5.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-5.31|-12.98|<0.0001
71140007|NCT03192176|141778521|SUPERIORITY||LSMean difference|-10.5|STANDARD_ERROR_OF_MEAN|1.98|<|0.0001|TWO_SIDED|95.0|-14.39|-6.61||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-6.61|-14.39|<0.0001
71140008|NCT03192176|141778521|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|1.98||0.0819|TWO_SIDED|95.0|-7.36|0.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||0.44|-7.36|0.0819
71140009|NCT03192176|141778521|SUPERIORITY||LSMean difference|-6.9|STANDARD_ERROR_OF_MEAN|1.95||0.0004|TWO_SIDED|95.0|-10.78|-3.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-3.09|-10.78|0.0004
71140010|NCT03192176|141778521|SUPERIORITY||LSMean difference|-6.9|STANDARD_ERROR_OF_MEAN|1.94||0.0005|TWO_SIDED|95.0|-10.69|-3.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-3.05|-10.69|0.0005
71140011|NCT03192176|141778521|SUPERIORITY||LSMean difference|-4.1|STANDARD_ERROR_OF_MEAN|1.98||0.038|TWO_SIDED|95.0|-8.01|-0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.23|-8.01|0.0380
71140012|NCT03192176|141778521|SUPERIORITY||LSMean difference|-7.6|STANDARD_ERROR_OF_MEAN|1.99||0.0002|TWO_SIDED|95.0|-11.46|-3.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-3.64|-11.46|0.0002
71140013|NCT03192176|141778521|SUPERIORITY||LSMean differencce|-8.1|STANDARD_ERROR_OF_MEAN|1.98|<|0.0001|TWO_SIDED|95.0|-11.96|-4.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-4.17|-11.96|<0.0001
71140014|NCT03192176|141778521|SUPERIORITY||LSMean difference|-9.2|STANDARD_ERROR_OF_MEAN|2.01|<|0.0001|TWO_SIDED|95.0|-13.17|-5.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-5.25|-13.17|<0.0001
71140015|NCT03192176|141778521|SUPERIORITY||LSMean difference|-4.6|STANDARD_ERROR_OF_MEAN|2.02||0.0245|TWO_SIDED|95.0|-8.52|-0.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.59|-8.52|0.0245
71140016|NCT03192176|141778521|SUPERIORITY||LSMean difference|-5.9|STANDARD_ERROR_OF_MEAN|1.99||0.0031|TWO_SIDED|95.0|-9.83|-2.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-2.01|-9.83|0.0031
71140017|NCT03192176|141778521|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|1.98||0.0046|TWO_SIDED|95.0|-9.53|-1.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-1.75|-9.53|0.0046
71140018|NCT03192176|141778521|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|2.04||0.0064|TWO_SIDED|95.0|-9.61|-1.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.59|-9.61|0.0064
71140019|NCT03192176|141778521|SUPERIORITY||LSMean difference|-8.7|STANDARD_ERROR_OF_MEAN|2.05|<|0.0001|TWO_SIDED|95.0|-12.72|-4.65||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-4.65|-12.72|<0.0001
71140020|NCT03192176|141778521|SUPERIORITY||LSMean difference|-8.8|STANDARD_ERROR_OF_MEAN|2.04|<|0.0001|TWO_SIDED|95.0|-12.78|-4.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-4.75|-12.78|<0.0001
70865480|NCT05047770|141216389|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the difference in percentage of participants seroconverted for anti-HI antibodies against the B/Yamagata influenza strain between FluD-QIVSeq group and FluD-QIVCoAd group was \< 10%.|Difference in percentage|-1.6|||||TWO_SIDED|95.0|-7.0|3.9|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of percentage of participants seroconverted for anti-HI antibodies against the B/Yamagata influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||3.9|-7.0|
70865481|NCT04289623|141216429|SUPERIORITY||Odds Ratio (OR)|1.19||||0.007|TWO_SIDED|95.0|1.05|1.35||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the previously enrolled group with the standard email as the reference group.||1.35|1.05|.007
70865482|NCT04289623|141216429|SUPERIORITY||Odds Ratio (OR)|0.82||||0.287|TWO_SIDED|95.0|0.56|1.19||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the never enrolled group with the standard email as the reference group.||1.19|0.56|.287
70865483|NCT04289623|141216429|SUPERIORITY||Odds Ratio (OR)|1.05||||0.59|TWO_SIDED|95.0|0.87|1.27||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the previously enrolled group with the rank-and-file email as the reference group.||1.27|0.87|.590
70865484|NCT04289623|141216429|SUPERIORITY||Odds Ratio (OR)|1.86||||0.035|TWO_SIDED|95.0|1.05|3.32||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the never enrolled group with the rank-and-file email as the reference group.||3.32|1.05|.035
71140021|NCT03192176|141778521|SUPERIORITY||LSMean difference|-10.2|STANDARD_ERROR_OF_MEAN|2.08|<|0.0001|TWO_SIDED|95.0|-14.27|-6.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-6.09|-14.27|<0.0001
70865485|NCT04289623|141216430|SUPERIORITY||Odds Ratio (OR)|1.16||||0.085|TWO_SIDED|95.0|0.98|1.37||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the previously enrolled group with the standard email as the reference group.||1.37|0.98|.085
70865486|NCT04289623|141216430|SUPERIORITY||Odds Ratio (OR)|0.89||||0.569|TWO_SIDED|95.0|0.6|1.33||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the never enrolled group with the standard email as the reference group.||1.33|0.60|.569
70865487|NCT04289623|141216430|SUPERIORITY||Odds Ratio (OR)|0.79||||0.24|TWO_SIDED|95.0|0.54|1.17||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the previously enrolled group with the rank-and-file email as the reference group.||1.17|0.54|.240
70865488|NCT04289623|141216430|SUPERIORITY||Odds Ratio (OR)|0.94||||0.871|TWO_SIDED|95.0|0.45|1.95||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the never enrolled group with the rank-and-file email as the reference group.||1.95|0.45|.871
70865489|NCT03758443|141216431|SUPERIORITY||Least Square Mean Difference|-0.27||||0.5809|TWO_SIDED|95.0|-1.22|0.69|||ANCOVA|||Least square estimates, 95% CI, and p-values were obtained by fitting an ANCOVA model with terms for treatment, steroid use at baseline (yes, no) and prior biologic failure (yes, no), and baseline total Mayo score as covariate.||0.69|-1.22|0.5809
70865490|NCT03758443|141216431|SUPERIORITY||Least Square Mean Difference|-0.37||||0.4501|TWO_SIDED|95.0|-1.33|0.59|||ANCOVA|||Least square estimates, 95% CI, and p-values were obtained by fitting an ANCOVA model with terms for treatment, steroid use at baseline (yes, no) and prior biologic failure (yes, no), and baseline total Mayo score as covariate.||0.59|-1.33|0.4501
70865491|NCT03758443|141216431|SUPERIORITY||Least Square Mean Difference|-0.65||||0.1809|TWO_SIDED|95.0|-1.6|0.3|||ANCOVA|||Least square estimates, 95% CI, and p-values were obtained by fitting an ANCOVA model with terms for treatment, steroid use at baseline (yes, no) and prior biologic failure (yes, no), and baseline total Mayo score as covariate.||0.30|-1.60|0.1809
70865492|NCT03758443|141216432|SUPERIORITY|||||||0.3762|||||||Fisher Exact|||||||0.3762
70865493|NCT03758443|141216432|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
70865494|NCT03758443|141216432|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
70865495|NCT03758443|141216433|SUPERIORITY||Difference in Proportion|0.0||||0.9542|TWO_SIDED|95.0|-0.104|0.11||P-value is shown for Cochran-Mantel Haenszel tests stratified by prior biologic failure and steroid use at baseline.|Cochran-Mantel-Haenszel||Difference in proportion estimates used Mantel-Haenszel stratum weights.|||0.110|-0.104|0.9542
70865496|NCT03758443|141216433|SUPERIORITY||Difference in Proportion|-0.03||||0.5863|TWO_SIDED|95.0|-0.126|0.071||P-value is shown for Cochran-Mantel Haenszel tests stratified by prior biologic failure and steroid use at baseline.|Cochran-Mantel-Haenszel||Difference in proportion estimates used Mantel-Haenszel stratum weights.|||0.071|-0.126|0.5863
70865497|NCT03758443|141216433|SUPERIORITY||Difference in Proportion|-0.03||||0.5408|TWO_SIDED|95.0|-0.131|0.069||P-value is shown for Conhran-Mantel Haenszel tests stratified by prior biologic failure and steroid use at baseline.|Cochran-Mantel-Haenszel||Difference in proportion estimates used Mantel-Haenszel stratum weights.|||0.069|-0.131|0.5408
70865498|NCT03758443|141216434|SUPERIORITY|||||||0.6656|||||||Fisher Exact|||||||0.6656
70865499|NCT03758443|141216434|SUPERIORITY|||||||0.6424|||||||Fisher Exact|||||||0.6424
70865500|NCT03758443|141216434|SUPERIORITY|||||||0.6199|||||||Fisher Exact|||||||0.6199
70865501|NCT03758443|141216435|SUPERIORITY|||||||0.2643|||||||Fisher Exact|||||||0.2643
70865502|NCT03758443|141216435|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
70865503|NCT03758443|141216435|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
70865504|NCT03758443|141216436|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
70865505|NCT03758443|141216436|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
70865506|NCT03758443|141216436|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
70948536|NCT00820664|141398229|SUPERIORITY_OR_OTHER||Least Squares Mean|0.49|||<|0.001||95.0|0.31|1.0||1-sided, alpha=0.05|ANOVA|A one-way ANOVA model with term treatment was fit to the square root transformed response.||||1.00|0.31|<0.001
70865507|NCT01436396|141216437|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 95% Confidence Interval (CI) was greater than -10. The difference in percentage of seroconversion rates between group 1 and 2 was based on the Wilson score (without continuity adjustment) 95% two-sided CI.|Difference in percentage|0.334|||||TWO_SIDED|95.0|-0.976|1.87||||||Non-inferiority of YF seroconversion rate was assessed 28 days post-Stamaril®/CYD dengue vaccine (CYD Dengue Vaccine Group) or post-Stamaril®/placebo (Placebo Group).||1.87|-0.976|
70865508|NCT01436396|141216438|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 95% CI is greater than -10. The difference in percentage of seroconversion rates between group 1 and 2 was based on the Wilson score (without continuity adjustment) 95% two-sided CI.|Difference in percentage|-1.06|||||TWO_SIDED|95.0|-2.81|0.383||||||Non-inferiority of YF seroconversion rate was assessed 28 days post-Stamaril®/CYD dengue vaccine (CYD Dengue Vaccine Group) or post-Stamaril®/placebo (Placebo Group).||0.383|-2.81|
70865509|NCT00178633|141216487|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<.0001
70865510|NCT00694707|141216527|SUPERIORITY_OR_OTHER||Least squares mean difference|-7.5||||0.0005|TWO_SIDED|95.0|-11.8|-3.3|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline PANSS total score as the covariate.||||-3.3|-11.8|0.0005
70865511|NCT00694707|141216527|SUPERIORITY_OR_OTHER||Least squares mean difference|-8.8|||<|0.0001|TWO_SIDED|95.0|-13.1|-4.6|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline PANSS total score as the covariate.||||-4.6|-13.1|<0.0001
70865512|NCT00694707|141216527|SUPERIORITY_OR_OTHER||Least squares mean difference|-10.4|||<|0.0001|TWO_SIDED|95.0|-14.6|-6.2|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline PANSS total score as the covariate.||||-6.2|-14.6|<0.0001
70865513|NCT00694707|141216527|SUPERIORITY_OR_OTHER||Least squares mean difference|-15.0|||<|0.0001|TWO_SIDED|95.0|-19.4|-10.8|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline PANSS total score as the covariate.||||-10.8|-19.4|<0.0001
70865514|NCT00694707|141216528|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.4||||0.004|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline CGI-S score as the covariate.||||-0.1|-0.6|0.0040
70948537|NCT00820664|141398229|SUPERIORITY_OR_OTHER||Least Squares Mean|0.19||||0.032||95.0|0.02|1.0||1-sided, alpha=0.05|ANOVA|A one-way ANOVA model with term treatment was fit to the square root transformed response.||||1.00|0.02|0.032
70948538|NCT03635086|141398231|OTHER||Geometric Mean Ratio Estimate|1.1||||0.9998|TWO_SIDED|95.0|0.2|4.9|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||4.9|0.2|0.9998
70948539|NCT03635086|141398231|OTHER||Geometric Mean Ratio Estimate|1.5||||0.9345|TWO_SIDED|95.0|0.3|7.5|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||7.5|0.3|0.9345
70865515|NCT00694707|141216528|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.5||||0.0003|TWO_SIDED|95.0|-0.7|-0.2|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline CGI-S score as the covariate.||||-0.2|-0.7|0.0003
70865516|NCT00694707|141216528|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.4|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline CGI-S score as the covariate.||||-0.4|-0.9|<0.0001
70865517|NCT00694707|141216528|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.6|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline CGI-S score as the covariate.||||-0.6|-1.1|<0.0001
70865518|NCT01904058|141216546|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.28||||0.6603|TWO_SIDED|95.0|-12.59|8.03||p-value (LUM001 LS Mean = Placebo LS Mean).|ANCOVA|||The difference between treatment groups in change from Baseline to Week 13/ET in ItchRO weekly sum score evaluated by analysis of covariance (ANCOVA) using generalized linear model (GLM). The model included terms for treatment group, alkaline phosphatase (ALP) level (strata), treatment group by ALP level interaction and Baseline ItchRO weekly sum score as a covariate. Least squares mean change from Baseline to Week 13/ET, along with 95 percentage (%) confidence interval for mean were presented.||8.03|-12.59|0.6603
70865519|NCT01904058|141216546|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.99||||0.438|TWO_SIDED|95.0|-14.2|6.23||p-value (LUM001 LS Mean = Placebo LS Mean).|ANCOVA|||The difference between treatment groups in change from Baseline to Week 13/ET in ItchRO weekly sum score was evaluated by ANCOVA using a GLM. The model included terms for treatment group, ALP level (strata), treatment group by ALP level interaction, and Baseline ItchRO weekly sum score as a covariate. Least squares mean change from Baseline to Week 13/ET, along with 95% confidence interval for the mean, were presented.||6.23|-14.20|0.4380
70865520|NCT00973674|141216596|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99|||||||Barnard's unconditional Exact Test|||||||0.99
70865521|NCT00973674|141216597|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.67||||0.033|TWO_SIDED|95.0|0.74|3.77|||Log Rank|||||3.77|0.74|.033
70865522|NCT00973674|141216598|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35|||||||t-test, 2 sided|||||||.35
70865523|NCT02713204|141216600|SUPERIORITY|Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.|Least square mean difference|0.02||||0.9894|TWO_SIDED|95.0|-2.99|3.03||Threshold for significance at 0.05 level.|ANCOVA|||||3.03|-2.99|0.9894
70865524|NCT02713204|141216600|SUPERIORITY||Least square mean difference|0.25||||0.8346|TWO_SIDED|95.0|-2.09|2.59|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.||2.59|-2.09|0.8346
70948540|NCT03635086|141398231|OTHER||Geometric Mean Ratio Estimate|0.5||||0.5836|TWO_SIDED|95.0|0.1|2.1|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||2.1|0.1|0.5836
70865525|NCT02713204|141216601|SUPERIORITY||Least square mean difference|-1.2||||0.4611|TWO_SIDED|95.0|-4.41|2.0||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||2.00|-4.41|0.4611
70865526|NCT02713204|141216601|SUPERIORITY|Threshold for significance at 0.05 level.|Least square mean difference|-2.0||||0.2225|TWO_SIDED|95.0|-5.22|1.22|||ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||1.22|-5.22|0.2225
70865527|NCT02713204|141216601|SUPERIORITY||Least square mean difference|-0.82||||0.6063|TWO_SIDED|95.0|-3.97|2.32||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||2.32|-3.97|0.6063
70865528|NCT02713204|141216601|SUPERIORITY||Least square mean difference|-3.25||||0.0426|TWO_SIDED|95.0|-6.39|-0.11||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||-0.11|-6.39|0.0426
70865529|NCT02713204|141216601|SUPERIORITY||Least square mean difference|-4.39||||0.0073|TWO_SIDED|95.0|-7.58|-1.19||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||-1.19|-7.58|0.0073
70865530|NCT02713204|141216601|SUPERIORITY||Least square mean difference|1.17||||0.469|TWO_SIDED|95.0|-2.01|4.36||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||4.36|-2.01|0.4690
70865531|NCT02713204|141216601|SUPERIORITY||Least square mean difference|2.42||||0.1267|TWO_SIDED|95.0|-0.69|5.54||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||5.54|-0.69|0.1267
70865532|NCT02713204|141216602|SUPERIORITY||Least square mean difference|-11.57||||0.413|TWO_SIDED|95.0|-39.5|16.2||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.||16.20|-39.5|0.4130
70865533|NCT02713204|141216602|SUPERIORITY||Least square mean difference|-4.88||||0.6587|TWO_SIDED|95.0|-26.2|16.85|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.||16.85|-26.2|0.6587
70865534|NCT02713204|141216603|SUPERIORITY||Least square mean difference|17.04||||0.3833|TWO_SIDED|95.0|-21.35|55.43||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||55.43|-21.35|0.3833
70865535|NCT02713204|141216603|SUPERIORITY||Least square mean difference|12.85||||0.5141|TWO_SIDED|95.0|-25.84|51.53||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||51.53|-25.84|0.5141
70865536|NCT02713204|141216603|SUPERIORITY||Least square mean difference|33.89||||0.0785|TWO_SIDED|95.0|-3.89|71.67|||ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||71.67|-3.89|0.0785
70865537|NCT02713204|141216603|SUPERIORITY||Least square mean difference|42.27||||0.0281|TWO_SIDED|95.0|4.56|79.98||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||79.98|4.56|0.0281
70865538|NCT02713204|141216603|SUPERIORITY||Least square mean difference|16.65||||0.3934|TWO_SIDED|95.0|-21.67|54.96||Threshold for significance at 0.05 level.|ANCOVA|||||54.96|-21.67|0.3934
70865539|NCT02713204|141216603|SUPERIORITY||Least square mean difference|21.05||||0.279|TWO_SIDED|95.0|-17.13|59.22||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||59.22|-17.13|0.2790
70865540|NCT02713204|141216603|SUPERIORITY||Least square mean difference|-8.38||||0.6586|TWO_SIDED|95.0|-45.64|28.88||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||28.88|-45.64|0.6586
70865541|NCT02713204|141216604|SUPERIORITY||Least square mean difference|0.55||||0.4889|TWO_SIDED|95.0|-1.01|2.1||Threshold for significance at 0.05 level.|ANCOVA|||||2.10|-1.01|0.4889
70865542|NCT02713204|141216604|SUPERIORITY||Least square mean difference|0.24||||0.7027|TWO_SIDED|95.0|-0.99|1.46||Threshold for significance at 0.05 level.|ANCOVA|||||1.46|-0.99|0.7027
70865543|NCT02713204|141216605|SUPERIORITY||Least square mean difference|-0.6||||0.4927|TWO_SIDED|95.0|-2.34|1.13||Threshold for significance at 0.05 level.|ANCOVA|||||1.13|-2.34|0.4927
70865544|NCT02713204|141216605|SUPERIORITY||Least square mean difference|0.38||||0.6645|TWO_SIDED|95.0|-1.36|2.13||Threshold for significance at 0.05 level.|ANCOVA|||||2.13|-1.36|0.6645
70865545|NCT02713204|141216605|SUPERIORITY||Least square mean difference|-0.89||||0.3091|TWO_SIDED|95.0|-2.61|0.83||Threshold for significance at 0.05 level.|ANCOVA|||||0.83|-2.61|0.3091
70865546|NCT02713204|141216605|SUPERIORITY||Least square mean difference|-0.6||||0.4898|TWO_SIDED|95.0|-2.29|1.1||Threshold for significance at 0.05 level.|ANCOVA|||||1.10|-2.29|0.4898
70865547|NCT02713204|141216605|SUPERIORITY||Least square mean difference|-0.8||||0.3504|TWO_SIDED|95.0|-2.5|0.89||Threshold for significance at 0.05 level.|ANCOVA|||||0.89|-2.50|0.3504
70865548|NCT02713204|141216605|SUPERIORITY||Least square mean difference|-0.98||||0.2632|TWO_SIDED|95.0|-2.7|0.74||Threshold for significance at 0.05 level.|ANCOVA|||||0.74|-2.70|0.2632
70865549|NCT02713204|141216605|SUPERIORITY||Least square mean difference|0.21||||0.8056|TWO_SIDED|95.0|-1.46|1.88||Threshold for significance at 0.05 level.|ANCOVA|||||1.88|-1.46|0.8056
70865550|NCT02713204|141216606|SUPERIORITY||Least square mean difference|0.57||||0.5065|TWO_SIDED|95.0|-1.11|2.25||Threshold for significance at 0.05 level.|ANCOVA|||||2.25|-1.11|0.5065
70948541|NCT03635086|141398231|OTHER||Geometric Mean Ratio Estimate|2.4||||0.4844|TWO_SIDED|95.0|0.5|10.6|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||10.6|0.5|0.4844
70948542|NCT03635086|141398231|OTHER||Geometric Mean Ratio Estimate|1.4||||0.9725|TWO_SIDED|95.0|0.3|6.8|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||6.8|0.3|0.9725
71140022|NCT03192176|141778521|SUPERIORITY||LSMean difference|-6.4|STANDARD_ERROR_OF_MEAN|2.08||0.0021|TWO_SIDED|95.0|-10.54|-2.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-2.36|-10.54|0.0021
71140023|NCT03192176|141778521|SUPERIORITY||LSMean difference|-7.7|STANDARD_ERROR_OF_MEAN|2.05||0.0002|TWO_SIDED|95.0|-11.71|-3.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-3.66|-11.71|0.0002
71140024|NCT03192176|141778521|SUPERIORITY||LSMean difference|-7.0|STANDARD_ERROR_OF_MEAN|2.04||0.0007|TWO_SIDED|95.0|-10.96|-2.95||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-2.95|-10.96|0.0007
71140025|NCT03192176|141778521|SUPERIORITY||LSMean difference|-5.5|STANDARD_ERROR_OF_MEAN|2.03||0.0075|TWO_SIDED|95.0|-9.46|-1.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-1.47|-9.46|0.0075
71140026|NCT03192176|141778521|SUPERIORITY||LSMean difference|-8.4|STANDARD_ERROR_OF_MEAN|2.04|<|0.0001|TWO_SIDED|95.0|-12.44|-4.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-4.42|-12.44|<0.0001
71140027|NCT03192176|141778521|SUPERIORITY||LSMean difference|-8.2|STANDARD_ERROR_OF_MEAN|2.03|<|0.0001|TWO_SIDED|95.0|-12.15|-4.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-4.16|-12.15|<0.0001
71140028|NCT03192176|141778521|SUPERIORITY||LSMean difference|-10.2|STANDARD_ERROR_OF_MEAN|2.07|<|0.0001|TWO_SIDED|95.0|-14.3|-6.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-6.16|-14.30|<0.0001
71140029|NCT03192176|141778521|SUPERIORITY||LSMean difference|-6.4|STANDARD_ERROR_OF_MEAN|2.06||0.0021|TWO_SIDED|95.0|-10.46|-2.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-2.34|-10.46|0.0021
71140030|NCT03192176|141778521|SUPERIORITY||LSMean difference|-8.3|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-12.25|-4.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-4.25|-12.25|<0.0001
71140031|NCT03192176|141778521|SUPERIORITY||LSMean difference|-7.6|STANDARD_ERROR_OF_MEAN|2.02||0.0002|TWO_SIDED|95.0|-11.58|-3.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-3.62|-11.58|0.0002
70865551|NCT02713204|141216606|SUPERIORITY||Least square mean difference|-0.22||||0.7418|TWO_SIDED|95.0|-1.55|1.1||Threshold for significance at 0.05 level.|ANCOVA|||||1.10|-1.55|0.7418
70865552|NCT02713204|141216607|SUPERIORITY||Least square mean difference|-0.19||||0.8383|TWO_SIDED|95.0|-1.99|1.62||Threshold for significance at 0.05 level.|ANCOVA|||||1.62|-1.99|0.8383
71140032|NCT03192176|141778521|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|1.92||0.0123|TWO_SIDED|95.0|-8.6|-1.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.05|-8.60|0.0123
71140033|NCT03192176|141778521|SUPERIORITY||LSMean difference|-7.8|STANDARD_ERROR_OF_MEAN|1.92|<|0.0001|TWO_SIDED|95.0|-11.63|-4.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-4.07|-11.63|<0.0001
71140034|NCT03192176|141778521|SUPERIORITY||LSMean difference|-8.0|STANDARD_ERROR_OF_MEAN|1.92|<|0.0001|TWO_SIDED|95.0|-11.8|-4.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-4.23|-11.80|<0.0001
70865553|NCT02713204|141216607|SUPERIORITY||Least square mean difference|-0.1||||0.918|TWO_SIDED|95.0|-1.91|1.72||Threshold for significance at 0.05 level.|ANCOVA|||||1.72|-1.91|0.9180
70865554|NCT02713204|141216607|SUPERIORITY||Least square mean difference|-1.41||||0.1238|TWO_SIDED|95.0|-3.2|0.39||Threshold for significance at 0.05 level.|ANCOVA|||||0.39|-3.20|0.1238
70865555|NCT02713204|141216607|SUPERIORITY||Least square mean difference|-0.97||||0.2819|TWO_SIDED|95.0|-2.73|0.8||Threshold for significance at 0.05 level.|ANCOVA|||||0.80|-2.73|0.2819
70948543|NCT03635086|141398231|OTHER||Geometric Mean Ratio Estimate|0.4||||0.4715|TWO_SIDED|95.0|0.1|1.9|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||1.9|0.1|0.4715
70948544|NCT03635086|141398231|OTHER||Geometric Mean Ratio Estimate|2.2||||0.5969|TWO_SIDED|95.0|0.5|9.6|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||9.6|0.5|0.5969
70865556|NCT02713204|141216607|SUPERIORITY||Least square mean difference|-1.02||||0.2581|TWO_SIDED|95.0|-2.78|0.75||Threshold for significance at 0.05 level.|ANCOVA|||||0.75|-2.78|0.2581
70865557|NCT02713204|141216607|SUPERIORITY||Least square mean difference|-0.87||||0.339|TWO_SIDED|95.0|-2.66|0.92||Threshold for significance at 0.05 level.|ANCOVA|||||0.92|-2.66|0.3390
70865558|NCT02713204|141216607|SUPERIORITY||Least square mean difference|0.05||||0.9558|TWO_SIDED|95.0|-1.69|1.79||Threshold for significance at 0.05 level.|ANCOVA|||||1.79|-1.69|0.9558
70865559|NCT03181893|141216638|OTHER||Mean Difference (Final Values)|-14.82|STANDARD_ERROR_OF_MEAN|3.183|<|0.0001|TWO_SIDED|90.0|-20.26|-9.37|||LANCOVA-P model|||||-9.37|-20.26|<0.0001
70865560|NCT03181893|141216655|OTHER||Least Squares Mean Difference|10.83|STANDARD_ERROR_OF_MEAN|10.274||0.1537|TWO_SIDED|90.0|-7.1|28.77|||Mixed Models Analysis|||Difference of the active treatment from Placebo at Week 4||28.77|-7.10|0.1537
70865561|NCT03181893|141216655|OTHER||Least Squares Mean Difference|12.5|STANDARD_ERROR_OF_MEAN|10.761||0.1312|TWO_SIDED|90.0|-6.29|31.29|||Mixed Models Analysis|||Difference of the active treatment from Placebo at Week 8||31.29|-6.29|0.1312
70948545|NCT03635086|141398231|OTHER||Geometric Mean Ratio Estimate|0.3||||0.2043|TWO_SIDED|95.0|0.1|1.4|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||1.4|0.1|0.2043
70948546|NCT03635086|141398231|OTHER||Geometric Mean Ratio Estimate|1.5||||0.9388|TWO_SIDED|95.0|0.3|7.4|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||7.4|0.3|0.9388
70948547|NCT03635086|141398231|OTHER||Geometric Mean Ratio Estimate|5.2||||0.0251|TWO_SIDED|95.0|1.2|23.1|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||23.1|1.2|0.0251
70865562|NCT03181893|141216655|OTHER||Least Squares Mean Difference|19.44|STANDARD_ERROR_OF_MEAN|12.161||0.0647|TWO_SIDED|90.0|-1.79|40.68|||Mixed Models Analysis|||Difference of the active treatment from Placebo at Week 12||40.68|-1.79|0.0647
70865563|NCT01254630|141216788|SUPERIORITY||Vaccine Efficacy|0.636|||||TWO_SIDED|97.5|0.364|0.791|||||Point estimate and 97.5% CI of vaccine efficacy (primary endpoint) were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 97.5% Confidence Interval (CI) be \>0.25.||0.791|0.364|
70865564|NCT01254630|141216789|OTHER||Risk Difference (RD)|1.4|||||TWO_SIDED|95.0|-1.8|4.5||||||||4.5|-1.8|
70865565|NCT01254630|141216790|OTHER||Vaccine Efficacy|0.771|||||TWO_SIDED|95.0|0.48|0.899|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI be \>0.25.||0.899|0.480|
70865566|NCT01254630|141216791|OTHER||Vaccine Efficacy|0.874|||||TWO_SIDED|95.0|-0.005|0.984|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI be \>0.25.||0.984|-0.005|
70865567|NCT01254630|141216792|OTHER||Vaccine Efficacy|0.746|||||TWO_SIDED|95.0|-1.275|0.972|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI be \>0.25.||0.972|-1.275|
70865568|NCT01254630|141216793|OTHER||Risk Difference (RD)|0.5|||||TWO_SIDED|95.0|-0.6|1.6||||||||1.6|-0.6|
70865569|NCT00761631|141216806|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.5|||||TWO_SIDED|95.0|1.24|1.8||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.80|1.24|
70865570|NCT00761631|141216806|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.78|1.15||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.15|0.78|
70865571|NCT00761631|141216806|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.8|1.12||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.12|0.80|
70865572|NCT00761631|141216806|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.19|1.76||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.76|1.19|
70865573|NCT00761631|141216806|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.59|0.86||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||0.86|0.59|
70865574|NCT00761631|141216806|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.5|||||TWO_SIDED|95.0|1.15|1.86||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.86|1.15|
70865575|NCT00761631|141216806|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.2|||||TWO_SIDED|95.0|0.97|1.42||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.42|0.97|
70865576|NCT00761631|141216806|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.7|||||TWO_SIDED|95.0|1.36|2.13||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||2.13|1.36|
70865577|NCT00761631|141216806|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.6|||||TWO_SIDED|95.0|0.48|0.67||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||0.67|0.48|
70865578|NCT00761631|141216806|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.53|0.89||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||0.89|0.53|
70865579|NCT00761631|141216806|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.3|||||TWO_SIDED|95.0|1.05|1.67||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.67|1.05|
70865580|NCT00761631|141216806|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.6|||||TWO_SIDED|95.0|0.53|0.76||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||0.76|0.53|
70865581|NCT00761631|141216806|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.91|1.28||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.28|0.91|
70865582|NCT03319173|141216811|OTHER||Mean Difference (Final Values)|8.24|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|7.79|8.7|||Regression, Linear|||||8.7|7.79|<0.0001
70865583|NCT03319173|141216812|OTHER||Estimate|0.35|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.31|0.39|||Regression, Linear|||||0.39|0.31|<0.0001
70865584|NCT03319173|141216813|OTHER||Estimate|0.46|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.41|0.52|||Regression, Linear|||||0.52|0.41|<0.0001
70865585|NCT03319173|141216814|OTHER||Estimate|0.514|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.47|0.56|||Regression, Linear|||||0.56|0.47|<0.0001
70865586|NCT03319173|141216815|OTHER||Estimate|0.44|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.4|0.49|||Regression, Linear|||||0.49|0.40|<0.0001
70865587|NCT03319173|141216816|OTHER||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.4|0.49|||Estimate|||||0.49|0.40|<0.0001
70865588|NCT03319173|141216817|OTHER||Estimate|0.75|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|0.72|0.78|||Regression, Linear|||||0.78|0.72|<0.0001
70865589|NCT03319173|141216818|OTHER||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.3|0.37|||Estimate|||||0.37|0.30|<0.0001
70865590|NCT03319173|141216819|OTHER||Estimate|0.87|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|0.85|0.88|||Regression, Linear|||||0.88|0.85|<0.0001
70865591|NCT03319173|141216820|OTHER||Estimate|0.87|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|0.85|0.88|||Regression, Linear|||||0.88|0.85|<0.0001
70865592|NCT03319173|141216821|OTHER||Estimate|0.75|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.71|0.8|||Regression, Linear|||||0.80|0.71|<0.0001
70865593|NCT03319173|141216822|OTHER||Estimate|0.51|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.47|0.56|||Regression, Linear|||||0.56|0.47|<0.0001
70865594|NCT03319173|141216823|OTHER||Estimate|1.13|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|1.104|1.156|||Regression, Linear|||||1.156|1.104|<0.0001
70865595|NCT03319173|141216824|OTHER||Estimate|1.037|||<|0.0001|TWO_SIDED|95.0|1.025|1.049|||Regression, Linear|||||1.049|1.025|<0.0001
70865596|NCT03319173|141216825|OTHER||Estimate|0.93|STANDARD_ERROR_OF_MEAN|0.008|<|0.0001|TWO_SIDED|95.0|0.91|0.94|||Regression, Linear|||||0.94|0.91|<0.0001
70865597|NCT03319173|141216826|OTHER||Estimate|1.122|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|1.096|1.149|||Regression, Linear|||||1.149|1.096|<0.0001
70865598|NCT03673046|141216827|SUPERIORITY||Mean Difference (Final Values)|-10.1255|STANDARD_ERROR_OF_MEAN|1.5705|<|0.0001|TWO_SIDED|95.0|-13.2532|-6.9978||The p-value was not adjusted for multiple comparisons because this was the pre-specified primary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a compound symmetry with heterogeneous variance covariance matrix.|The effect is presented as the Smartphone-delivered CBT for BDD group outcome compared to the 12-eeek waitlist control group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in BDD-YBOCS total scores between the treatment groups at endpoint (week 12).||-6.9978|-13.2532|<.0001
70865599|NCT03673046|141216828|SUPERIORITY||Mean Difference (Final Values)|-3.2648|STANDARD_ERROR_OF_MEAN|1.0346||0.0023|TWO_SIDED|95.0|-5.3275|-1.2022||The p-value was not adjusted for multiple comparisons because this was a pre-specified secondary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an auto-correlation with heterogeneous variance (ARH(1)) covariance matrix.|The effect is presented as the Smartphone-delivered CBT for BDD group outcome compared to the 12-week waitlist control group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in QIDS-SR total scores between the treatment groups at endpoint (week 12).||-1.2022|-5.3275|0.0023
70865600|NCT03673046|141216829|SUPERIORITY||Mean Difference (Final Values)|-4.8412|STANDARD_ERROR_OF_MEAN|1.1195|<|0.0001|TWO_SIDED|95.0|-7.0698|-2.6126||The p-value was not adjusted for multiple comparisons because this was a pre-specified secondary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a compound symmetry with heterogeneous variance covariance matrix.|The effect is presented as the Smartphone-delivered CBT for BDD group outcome compared to the 12-week waitlist control group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in BABS total scores between the treatment groups at endpoint (week 12).||-2.6126|-7.0698|<.0001
70865601|NCT03673046|141216830|SUPERIORITY||Mean Difference (Final Values)|-5.8847|STANDARD_ERROR_OF_MEAN|1.676||0.0008|TWO_SIDED|95.0|-9.2237|-2.5458||The p-value was not adjusted for multiple comparisons because this was a pre-specified secondary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an auto-correlation with heterogeneous variance (ARH(1)) covariance matrix.|The effect is presented as the Smartphone-delivered CBT for BDD group outcome compared to the 12-week waitlist control group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in SDS total scores between the treatment groups at endpoint (week 12).||-2.5458|-9.2237|.0008
70865602|NCT03673046|141216831|SUPERIORITY||Mean Difference (Final Values)|11.7529|STANDARD_ERROR_OF_MEAN|3.4553||0.0011|TWO_SIDED|95.0|4.863|18.6428||The p-value was not adjusted for multiple comparisons because this was a pre-specified secondary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a compound symmetry with heterogeneous variance covariance matrix.|The effect is presented as the Smartphone-delivered CBT for BDD group outcome compared to the 12-week waitlist control group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in Q-LESQ-SF total scores between the treatment groups at endpoint (week 12).||18.6428|4.8630|.0011
70865603|NCT01896050|141216843|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Compare difference in change in body mass index between baseline and 12 months between aromatase inhibitor- and tamoxifen-treated patients||||0.03
70865604|NCT01896050|141216843|SUPERIORITY_OR_OTHER||BMI squared|-0.01845|STANDARD_ERROR_OF_MEAN|0.02308||0.4262|TWO_SIDED||||||Regression, Linear|||Examine association between change in body mass index and change in grip strength with aromatase inhibitor therapy. For the primary outcome, linear regression was used for analysis with change of grip strength as response variable. In the original statistical analysis plan only aromatase inhibitor-treated patients were to be included in this analysis. This analysis was not performed on the tamoxifen group because it isn't clinically relevant.||||0.4262
70865605|NCT01896050|141216844|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in maximum grip strength between baseline and 12 months for aromatase inhibitor-treated versus tamoxifen-treated patients||||0.032
70865606|NCT01896050|141216845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.92|1.04||||||Association between baseline body mass index and discontinuation of aromatase inhibitor therapy. The original statistical analysis plan only called for analyzing the aromatase inhibitor-treated patients, not the tamoxifen-treated patients.||1.04|0.92|
70865607|NCT03693300|141216860|OTHER||Proportion (%)|6.1|||||TWO_SIDED|95.0|2.5|12.24|||||95% CI were based on the Clopper-Pearson method.|Any possibly related adverse events of CTCAE Grade 3 or Grade 4||12.24|2.50|
70865608|NCT03693300|141216860|OTHER||Proportion (%)|0.0|||||TWO_SIDED|95.0|0.0|70.76|||||95% CI were based on the Clopper-Pearson method.|Any possibly related adverse events of CTCAE Grade 3 or Grade 4||70.76|0.00|
70865609|NCT03693300|141216860|OTHER||Proportion (%)|6.0|||||TWO_SIDED|95.0|2.44|11.94|||||95% CI were based on the Clopper-Pearson method.|Any possibly related adverse events of CTCAE Grade 3 or Grade 4||11.94|2.44|
70865610|NCT03693300|141216860|OTHER||Proportion (%)|4.4|||||TWO_SIDED|95.0|1.44|9.94|||||95% CI were based on the Clopper-Pearson method.|Any possibly related AEs of Grade 3 or Grade 4 with onset date within 6 months of the first dose||9.94|1.44|
70865611|NCT03693300|141216860|OTHER||Proportion (%)|0.0|||||TWO_SIDED|95.0|0.0|70.76|||||95% CI were based on the Clopper-Pearson method.|Any possibly related AEs of Grade 3 or Grade 4 with onset date within 6 months of the first dose||70.76|0.00|
70865612|NCT03693300|141216860|OTHER||Proportion (%)|4.3|||||TWO_SIDED|95.0|1.4|9.69|||||95% CI were based on the Clopper-Pearson method.|Any possibly related AEs of Grade 3 or Grade 4 with onset date within 6 months of the first dose||9.69|1.40|
70865613|NCT00866788|141216886|SUPERIORITY_OR_OTHER|||||||0.1601||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.1601
70865614|NCT00866788|141216886|SUPERIORITY_OR_OTHER|||||||0.0003||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0003
70865615|NCT00866788|141216886|SUPERIORITY_OR_OTHER|||||||0.0473||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0473
70865616|NCT00866788|141216887|SUPERIORITY_OR_OTHER|||||||0.164||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.1640
70865617|NCT00866788|141216887|SUPERIORITY_OR_OTHER|||||||0.0005||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0005
70865618|NCT00866788|141216887|SUPERIORITY_OR_OTHER|||||||0.0558||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0558
70865619|NCT00866788|141216888|SUPERIORITY_OR_OTHER|||||||0.1411||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.1411
70865620|NCT00866788|141216888|SUPERIORITY_OR_OTHER|||||||0.0003||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0003
70865621|NCT00866788|141216888|SUPERIORITY_OR_OTHER|||||||0.0248||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0248
70865622|NCT00866788|141216889|SUPERIORITY_OR_OTHER|||||||0.5507||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.5507
70865623|NCT00866788|141216889|SUPERIORITY_OR_OTHER|||||||0.1525||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.1525
70865624|NCT00866788|141216889|SUPERIORITY_OR_OTHER|||||||0.0449||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0449
70865625|NCT00866788|141216890|SUPERIORITY_OR_OTHER|||||||0.7261||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.7261
70865626|NCT00866788|141216890|SUPERIORITY_OR_OTHER|||||||0.162||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.162
70865627|NCT00866788|141216890|SUPERIORITY_OR_OTHER|||||||0.6504||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.6504
70865628|NCT02742441|141216897|SUPERIORITY||||||<|0.001||||||"Treatment groups were compared with respect to the proportions of subjects with treatment success at Day 15 using the Cochran-Mantel-Haenszel (CMH) test stratified by analysis center."|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||||||<0.001
70865629|NCT02742441|141216898|SUPERIORITY||||||<|0.001||||||Statistical significance was achieved for each of the clinical signs of psoriasis.|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (plaque elevation, scaling, and erythema).||||<0.001
70865630|NCT02742441|141216899|SUPERIORITY|||||||0.012|||||||Cochran-Mantel-Haenszel|||||||0.012
70865631|NCT02495831|141216932|SUPERIORITY_OR_OTHER||point estimate (ratio of geometric means|90.0||||0.1|TWO_SIDED|90.0|80.0|125.0||If the upper limit of the 90% confidence interval is \< 125.00%, no effect of safinamide on diclofenamic acid bioavailability is present (no interaction present).|ANOVA|||The PK parameters AUC0-t and Cmax were analysed using analysis of variance (ANOVA). Before analysis, the data were transformed using a neperian logarithmic transformation. ANOVA was performed taking into account treatment, period, sequence and subject (sequence) as fixed effects with a variance components structure of the covariance matrix.||125|80|0.1
70865632|NCT02495831|141216933|SUPERIORITY_OR_OTHER||geometric mean ratio|104.84|||||TWO_SIDED|90.0|96.4|114.02||||||||114.02|96.40|
70865633|NCT03789396|141216937|SUPERIORITY||Odds Ratio (OR)|0.74|STANDARD_ERROR_OF_MEAN|0.14||0.03|TWO_SIDED|95.0|0.57|0.97|||Regression, Logistic|||Comparison of patient odds of being hyperoxic and not on room air pre- versus post-intervention||0.97|0.57|0.03
70865634|NCT02281773|141216960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.79||0.1256|TWO_SIDED|95.0|-2.76|0.34||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|Mixed Models Analysis|Unstructured covariance structure has been used to fit the mixed model. Kenward-Roger was used to model degrees of freedom.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 10 mg minus Placebo.|The restricted maximum likelihood (REML) based mixed effects model with repeated measurements (MMRM) was used with baseline value as fixed covariate and planned treatment, analysis visit, first test done, geographic region grouping 1, planned treatment by analysis visit and baseline value by analysis visit as fixed effects.||0.34|-2.76|0.1256
70948548|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups|Geometric Mean Ratio Estimate|0.6||||0.5263|TWO_SIDED|95.0|0.2|1.6|||ANOVA|||Day 0||1.6|0.2|0.5263
70865635|NCT02281773|141216960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.8||0.7337|TWO_SIDED|95.0|-1.3|1.84||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|Mixed Models Analysis|Unstructured covariance structure has been used to fit the mixed model. Kenward-Roger was used to model degrees of freedom.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 25 mg minus Placebo.|The restricted maximum likelihood (REML) based mixed effects model with repeated measurements (MMRM) was used with baseline value as fixed covariate and planned treatment, analysis visit, first test done, geographic region grouping 1, planned treatment by analysis visit and baseline value by analysis visit as fixed effects.||1.84|-1.30|0.7337
70872205|NCT01727297|141229672|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.66|TWO_SIDED|95.0|0.74|1.59||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having diabetes on a patient's risk of developing AF.|The null hypothesis was that diabetes did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.59|0.74|0.66
70948549|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.4|2.8|||ANOVA|||Day 0||2.8|0.4|1.0000
70948550|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.4|2.7|||ANOVA|||Day 0||2.7|0.4|1.0000
70948551|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.4|2.7|||ANOVA|||Day 0||2.7|0.4|1.0000
70948552|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|1.7||||0.55|TWO_SIDED|95.0|0.6|4.7|||ANOVA|||Day 0||4.7|0.6|0.5500
70948553|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|1.7||||0.5263|TWO_SIDED|95.0|0.6|4.6|||ANOVA|||Day 0||4.6|0.6|0.5263
70948554|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.7||||0.5263|TWO_SIDED|95.0|0.6|4.6|||ANOVA|||Day 0||4.6|0.6|0.5263
70948555|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.4|2.8|||ANOVA|||Day 0||2.8|0.4|1.0000
70948556|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.4|2.8|||ANOVA|||Day 0||2.8|0.4|1.0000
70865636|NCT02281773|141216960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.83||0.6994|TWO_SIDED|95.0|-1.31|1.95||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|Mixed Models Analysis|Unstructured covariance structure has been used to fit the mixed model. Kenward-Roger was used to model degrees of freedom.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 50 mg minus Placebo.|The restricted maximum likelihood (REML) based mixed effects model with repeated measurements (MMRM) was used with baseline value as fixed covariate and planned treatment, analysis visit, first test done, geographic region grouping 1, planned treatment by analysis visit and baseline value by analysis visit as fixed effects.||1.95|-1.31|0.6994
70865637|NCT02281773|141216960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.79||0.427|TWO_SIDED|95.0|-2.19|0.93||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|Mixed Models Analysis|Unstructured covariance structure has been used to fit the mixed model. Kenward-Roger was used to model degrees of freedom.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 100 mg minus Placebo.|The restricted maximum likelihood (REML) based mixed effects model with repeated measurements (MMRM) was used with baseline value as fixed covariate and planned treatment, analysis visit, first test done, geographic region grouping 1, planned treatment by analysis visit and baseline value by analysis visit as fixed effects.||0.93|-2.19|0.4270
70865638|NCT02281773|141216965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.66||0.5972|TWO_SIDED|95.0|-0.9|1.6||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 10 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||1.6|-0.9|0.5972
70872206|NCT01727297|141229672|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.73|TWO_SIDED|95.0|0.69|1.69||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having heart failure on a patient's risk of developing AF.|The null hypothesis was that heart failure did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.69|0.69|0.73
70865639|NCT02281773|141216965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.68||0.3817|TWO_SIDED|95.0|-1.9|0.7||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 25 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||0.7|-1.9|0.3817
70865640|NCT02281773|141216965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.68||0.48|TWO_SIDED|95.0|-0.9|1.8||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 50 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||1.8|-0.9|0.4800
70865641|NCT02281773|141216965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.66||0.7507|TWO_SIDED|95.0|-1.1|1.5||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 100 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||1.5|-1.1|0.7507
70865642|NCT02281773|141216966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.9399|TWO_SIDED|95.0|-0.1|0.1||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 10 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||0.1|-0.1|0.9399
70865643|NCT02281773|141216966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.9919|TWO_SIDED|95.0|-0.1|0.1||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 25 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||0.1|-0.1|0.9919
70865644|NCT02281773|141216966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.06||0.3027|TWO_SIDED|95.0|-0.1|0.2||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 50 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||0.2|-0.1|0.3027
70865645|NCT02281773|141216966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.06||0.3901|TWO_SIDED|95.0|-0.1|0.2||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 100 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||0.2|-0.1|0.3901
70865646|NCT02899299|141217014|SUPERIORITY|Treatment A over Treatment B|Hazard Ratio (HR)|0.74||||0.002|TWO_SIDED|96.6|0.6|0.91||Boundary for statistical significance was a p-value \< 0.0345|Stratified Log Rank|This is 2 sided p-value from log-rank test stratified by histology and sex as entered in the IRT|Stratified Cox proportional hazard model|||0.91|0.60|0.0020
70865647|NCT02899299|141217017|SUPERIORITY|Treatment A over Treatment B|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.77|1.13|||||Stratified Cox proportional hazard model|||1.13|0.77|
70865648|NCT02899299|141217018|SUPERIORITY|Treatment A vs Treatment B|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.64|1.32||||||\<1% PD-L1||1.32|0.64|
70865649|NCT02899299|141217018|SUPERIORITY|Treatment A vs Treatment B|Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.59|0.88||||||≥1% PD-L1||0.88|0.59|
70865650|NCT02899299|141217019|SUPERIORITY|Treatment A vs Treatment B|Hazard Ratio (HR)|1.79|||||TWO_SIDED|95.0|1.22|2.63||||||\< 1% PD-L1||2.63|1.22|
71140035|NCT03192176|141778521|SUPERIORITY||LSMean difference|-9.9|STANDARD_ERROR_OF_MEAN|1.95|<|0.0001|TWO_SIDED|95.0|-13.73|-6.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-6.03|-13.73|<0.0001
71140036|NCT03192176|141778521|SUPERIORITY||LSMean difference|-6.3|STANDARD_ERROR_OF_MEAN|1.95||0.0013|TWO_SIDED|95.0|-10.13|-2.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-2.47|-10.13|0.0013
71140037|NCT03192176|141778521|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.92||0.0002|TWO_SIDED|95.0|-10.97|-3.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-3.41|-10.97|0.0002
71140038|NCT03192176|141778521|SUPERIORITY||LSMean difference|-6.7|STANDARD_ERROR_OF_MEAN|1.91||0.0006|TWO_SIDED|95.0|-10.41|-2.89||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-2.89|-10.41|0.0006
71140039|NCT03192176|141778521|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|1.9||0.0119|TWO_SIDED|95.0|-8.54|-1.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.07|-8.54|0.0119
71140040|NCT03192176|141778521|SUPERIORITY||LSMean difference|-6.8|STANDARD_ERROR_OF_MEAN|1.9||0.0004|TWO_SIDED|95.0|-10.58|-3.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-3.09|-10.58|0.0004
71140041|NCT03192176|141778521|SUPERIORITY||LSMean difference|-7.8|STANDARD_ERROR_OF_MEAN|1.91|<|0.0001|TWO_SIDED|95.0|-11.57|-4.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-4.06|-11.57|<0.0001
70865651|NCT02899299|141217019|SUPERIORITY|Treatment A vs Treatment B|Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.61|0.96||||||≥1% PD-L1||0.96|0.61|
70865652|NCT02899299|141217021|SUPERIORITY|Treatment A over Treatment B|Hazard Ratio (HR)|0.74||||0.0008|TWO_SIDED|95.0|0.62|0.88|||Stratified Log Rank|This is 2 sided p-value from log-rank test stratified by histology and sex as entered in the IRT|Stratified Cox proportional hazard model|||0.88|0.62|0.0008
70865653|NCT00313300|141217022|SUPERIORITY_OR_OTHER||Adjusted rate difference|2.2|||||TWO_SIDED|95.0|-1.0|5.4|||||adjusted difference of event rates takes into consideration stratification factors.|||5.4|-1.0|
70865654|NCT00313300|141217022|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|3.8|||||TWO_SIDED|95.0|0.4|7.3|||||adjusted difference of event rates takes into consideration stratification factors.|||7.3|0.4|
70865655|NCT00313300|141217023|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.44|1.19||||||||1.19|0.44|
70865656|NCT00313300|141217023|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.35|1.04||||||||1.04|0.35|
70865657|NCT00313300|141217024|SUPERIORITY_OR_OTHER||Adjusted rate difference|6.6|||||TWO_SIDED|95.0|1.8|11.3|||||adjusted difference of event rates takes into consideration stratification factors.|||11.3|1.8|
70865658|NCT00313300|141217024|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|10.0|||||TWO_SIDED|95.0|4.8|15.2|||||adjusted difference of event rates takes into consideration stratification factors.|||15.2|4.8|
70865659|NCT00313300|141217025|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.44|1.17||||||||1.17|0.44|
70865660|NCT00313300|141217025|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.37|1.07||||||||1.07|0.37|
70865661|NCT00313300|141217026|SUPERIORITY_OR_OTHER||Adjusted rate difference|0.3|||||TWO_SIDED|95.0|-1.3|2.0|||||adjusted difference of event rates takes into consideration stratification factors.|||2.0|-1.3|
70865662|NCT00313300|141217026|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|0.8|||||TWO_SIDED|95.0|-1.1|2.7|||||adjusted difference of event rates takes into consideration stratification factors.|||2.7|-1.1|
70865663|NCT00313300|141217027|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.44|2.88||||||||2.88|0.44|
70865664|NCT00313300|141217027|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.29|2.57||||||||2.57|0.29|
70865665|NCT00313300|141217027|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.3|1.66||||||||1.66|0.30|
70865666|NCT00313300|141217027|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.3|1.74||||||||1.74|0.30|
70865667|NCT00313300|141217028|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|4.0|||||TWO_SIDED|95.0|0.0|8.1||||||||8.1|0.0|
70865668|NCT00313300|141217028|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|4.7|||||TWO_SIDED|95.0|0.0|9.3||||||||9.3|0.0|
70865669|NCT00313300|141217028|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|7.0|||||TWO_SIDED|95.0|3.4|10.5||||||||10.5|3.4|
70865670|NCT00313300|141217028|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|4.7|||||TWO_SIDED|95.0|1.4|8.0||||||||8.0|1.4|
70865671|NCT00313300|141217029|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|8.3|||||TWO_SIDED|95.0|1.8|14.9||||||||14.9|1.8|
70865672|NCT00313300|141217029|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|10.9|||||TWO_SIDED|95.0|3.4|18.4||||||||18.4|3.4|
70948557|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.4|2.7|||ANOVA|||Day 0||2.7|0.4|1.0000
71140042|NCT03192176|141778521|SUPERIORITY||LSMean difference|-9.1|STANDARD_ERROR_OF_MEAN|1.94|<|0.0001|TWO_SIDED|95.0|-12.89|-5.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-5.27|-12.89|<0.0001
70865673|NCT00313300|141217029|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|17.4|||||TWO_SIDED|95.0|11.6|23.2||||||||23.2|11.6|
70865674|NCT00313300|141217029|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|10.4|||||TWO_SIDED|95.0|5.6|15.1||||||||15.1|5.6|
70865675|NCT00313300|141217030|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.13|||||TWO_SIDED|95.0|0.44|2.88||||||||2.88|0.44|
70865676|NCT00313300|141217030|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86|||||TWO_SIDED|95.0|0.29|2.57||||||||2.57|0.29|
70865677|NCT00313300|141217030|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.71|||||TWO_SIDED|95.0|0.3|1.66||||||||1.66|0.30|
70865678|NCT00313300|141217030|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.72|||||TWO_SIDED|95.0|0.3|1.74||||||||1.74|0.30|
70865679|NCT00313300|141217031|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|0.8|||||TWO_SIDED|95.0|-0.9|2.6||||||||2.6|-0.9|
70948558|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.5||||0.5321|TWO_SIDED|95.0|0.2|1.7|||ANOVA|||Day 28||1.7|0.2|0.5321
70948559|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.1||||0.9983|TWO_SIDED|95.0|0.3|3.9|||ANOVA|||Day 28||3.9|0.3|0.9983
70948560|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.8234|TWO_SIDED|95.0|0.2|2.1|||ANOVA|||Day 28||2.1|0.2|0.8234
71140043|NCT03192176|141778521|SUPERIORITY||LSMean difference|-5.4|STANDARD_ERROR_OF_MEAN|1.93||0.0057|TWO_SIDED|95.0|-9.18|-1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.58|-9.18|0.0057
70865680|NCT00313300|141217031|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|2.9|||||TWO_SIDED|95.0|0.6|5.1||||||||5.1|0.6|
70865681|NCT00313300|141217031|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|4.1|||||TWO_SIDED|95.0|1.3|6.9||||||||6.9|1.3|
70865682|NCT01926015|141217055|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Diphtheria Toxin \>=0.1 IU/mL||3.95|-3.99|<0.001
70865683|NCT01926015|141217055|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Tetanus Toxin \>=0.01 IU/mL||3.95|-3.99|<0.001
70865684|NCT01926015|141217055|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Pertussis Toxin \>=10 EU/mL||3.95|-3.99|<0.001
70865685|NCT01926015|141217055|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Pertussis FHA \>=10 EU/mL||3.95|-3.99|<0.001
70865686|NCT01926015|141217055|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Poliovirus Type 1 NA \>=8||3.95|-3.99|<0.001
70865687|NCT01926015|141217055|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Poliovirus Type 2 NA \>=8||3.95|-3.99|<0.001
70865688|NCT01926015|141217055|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Poliovirus Type 3 NA \>=8||3.95|-3.99|<0.001
70865689|NCT01364649|141217083|SUPERIORITY_OR_OTHER||LS mean difference|2.2|STANDARD_ERROR_OF_MEAN|0.9||0.013|TWO_SIDED|95.0|0.48|4.02|||Mixed Model Repeated Measurements|The primary analysis was performed by using observed case data only.||||4.02|0.48|0.013
70865690|NCT02468232|141217090|SUPERIORITY||Hazard Ratio (HR)|1.0881||||0.626|TWO_SIDED|95.0|0.6501|1.8212|||Regression, Cox|||For Primary Composite||1.8212|0.6501|0.6260
70948561|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.8||||0.9882|TWO_SIDED|95.0|0.2|2.7|||ANOVA|||Day 28||2.7|0.2|0.9882
70948562|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.2||||0.3778|TWO_SIDED|95.0|0.6|7.6|||ANOVA|||Day 28||7.6|0.6|0.3778
70948563|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.2||||0.9878|TWO_SIDED|95.0|0.4|4.1|||ANOVA|||Day 28||4.1|0.4|0.9878
70948564|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.6||||0.8213|TWO_SIDED|95.0|0.5|5.3|||ANOVA|||Day 28||5.3|0.5|0.8213
70948565|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.6716|TWO_SIDED|95.0|0.2|1.9|||ANOVA|||Day 28||1.9|0.2|0.6716
70948566|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.7||||0.938|TWO_SIDED|95.0|0.2|2.5|||ANOVA|||Day 28||2.5|0.2|0.9380
70865691|NCT02468232|141217090|SUPERIORITY||Hazard Ratio (HR)|1.1701||||0.6493|TWO_SIDED|95.0|0.5242|2.6122|||Regression, Cox|||For CV Death||2.6122|0.5242|0.6493
70865692|NCT02468232|141217090|SUPERIORITY||Hazard Ratio (HR)|1.2673||||0.7851|TWO_SIDED|95.0|0.7039|2.2818|||Regression, Cox|||For 1st HF Hospitalization||2.2818|0.7039|0.7851
70865693|NCT02468232|141217091|SUPERIORITY||LSM of ratio|0.8657||||0.0326|TWO_SIDED|95.0|0.7585|0.988||Indicates statistical significance (2-sided) with an alpha level of 0.05|ANCOVA|Repeated measure ANCOVA model||Week 4 analysis||0.9880|0.7585|0.0326
70865694|NCT02468232|141217091|SUPERIORITY||LSM of ratio|0.8538||||0.0161|TWO_SIDED|95.0|0.7509|0.9708||Indicates statistical significance (2-sided) with an alpha level of 0.05|ANCOVA|Repeated measure ANCOVA model||Week 8 analysis||0.9708|0.7509|0.0161
70865695|NCT02468232|141217091|SUPERIORITY||LSM of ratio|0.8112||||0.0104|TWO_SIDED|95.0|0.6916|0.9514||Indicates statistical significance (2-sided) with an alpha level of 0.05|ANCOVA|Repeated measure of ANCOVA model||Month 6 analysis||0.9514|0.6916|0.0104
70865696|NCT02468232|141217093|SUPERIORITY||Hazard Ratio (HR)|1.024||||0.5406|TWO_SIDED|95.0|0.6492|1.6152|||Regression, Cox|||First triple composite endpoint||1.6152|0.6492|0.5406
70865697|NCT02468232|141217093|SUPERIORITY||Hazard Ratio (HR)|1.1701||||0.6493|TWO_SIDED|95.0|0.5242|2.6122|||Regression, Cox|||CV health||2.6122|0.5242|0.6493
70865698|NCT02468232|141217093|SUPERIORITY||Hazard Ratio (HR)|0.8546||||0.3448|TWO_SIDED|95.0|0.3952|1.8479|||Regression, Cox|||First worsening of HF in outpatient||1.8479|0.3952|0.3448
70865699|NCT02468232|141217094|SUPERIORITY|||||||0.7115|||||||Cochran-Mantel-Haenszel|based on modified ridit scores||Week 4 analysis||||0.7115
70865700|NCT02468232|141217094|SUPERIORITY|||||||0.1752|||||||Cochran-Mantel-Haenszel|based on modified ridit scores||Week 8 analysis||||0.1752
70865701|NCT02468232|141217094|SUPERIORITY|||||||0.2688|||||||Cochran-Mantel-Haenszel|based on modified ridit scores||Month 6 analysis||||0.2688
70865702|NCT02468232|141217095|SUPERIORITY||LSM of difference|2.5455||||0.1854|TWO_SIDED|95.0|-1.2306|6.3216|||ANCOVA|Repeated measure ANCOVA model||Week 8 analysis||6.3216|-1.2306|0.1854
70865703|NCT02468232|141217095|SUPERIORITY||LSM of difference|1.2695||||0.5737|TWO_SIDED|95.0|-3.1715|5.7104|||ANCOVA|Repeated measure ANCOVA model||Month 6 analysis||5.7104|-3.1715|0.5737
70865704|NCT02468232|141217096|SUPERIORITY||rate ratio|0.8699||||0.6501||95.0|0.4763|1.5887|||Negative binomial (NB) regression model|adjusted for treatment and stratification of screening NT-proBNP||||1.5887|0.4763|0.6501
70865705|NCT02468232|141217097|SUPERIORITY|||||||0.6211|||||||Cochran-Mantel-Haenszel|||||||0.6211
70948567|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.3||||0.9777|TWO_SIDED|95.0|0.4|4.3|||ANOVA|||Day 28||4.3|0.4|0.9777
70865706|NCT02468232|141217099|SUPERIORITY||Hazard Ratio (HR)|1.1895||||0.6955|TWO_SIDED|95.0|0.6116|2.3134|||Regression, Cox|||||2.3134|0.6116|0.6955
70865707|NCT02468232|141217101|SUPERIORITY||Rate ratio|1.0192||||0.9233|TWO_SIDED|95.0|0.6925|1.4999|||Negative binomial (NB) regression model|adjusted for treatment and stratification of screening NT-proBNP||||1.4999|0.6925|0.9233
70865708|NCT02468232|141217102|SUPERIORITY||Rate ratio|1.0754||||0.9272|TWO_SIDED|95.0|0.2264|5.1067|||Negative binomial (NB) regression model|adjusted for treatment and stratification of screening NT-proBNP||||5.1067|0.2264|0.9272
70865709|NCT02468232|141217104|SUPERIORITY||Rate ratio|0.4504||||0.0697|TWO_SIDED|95.0|0.1902|1.0665||Negative binomial (NB) regression model|Negative binomial (NB) regression model|adjusted for treatment and stratification of screening NT-proBNP||||1.0665|0.1902|0.0697
70865710|NCT03423641|141217123|SUPERIORITY||Odds Ratio (OR)|0.81||||0.68|TWO_SIDED|95.0|0.3|2.2|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||2.20|0.30|.68
70865711|NCT03423641|141217124|SUPERIORITY||Odds Ratio (OR)|0.71||||0.01|TWO_SIDED|95.0|0.56|0.91|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||0.91|0.56|0.01
70865712|NCT03423641|141217125|SUPERIORITY||Odds Ratio (OR)|0.92||||0.39|TWO_SIDED|95.0|0.75|1.12|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||1.12|0.75|0.39
70865713|NCT03423641|141217126|SUPERIORITY||Odds Ratio (OR)|0.67||||0.01|TWO_SIDED|95.0|0.49|0.9|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||0.90|0.49|0.01
70865714|NCT03423641|141217127|SUPERIORITY||Odds Ratio (OR)|0.42|||<|0.01|TWO_SIDED|95.0|0.3|0.59|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||0.59|0.30|<0.01
70865715|NCT03423641|141217128|SUPERIORITY||Odds Ratio (OR)|0.68||||0.12|TWO_SIDED|95.0|0.42|1.1|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||1.10|0.42|0.12
70865716|NCT03423641|141217129|SUPERIORITY||Odds Ratio (OR)|0.61||||0.34|TWO_SIDED|95.0|0.22|1.7|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||1.70|0.22|0.34
70865717|NCT03423641|141217130|SUPERIORITY||Marginal Structural Model|0.61|||<|0.01|TWO_SIDED|95.0|0.49|0.76|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||0.76|0.49|<0.01
70865718|NCT03423641|141217131|SUPERIORITY||Rate Ratio|0.71|||<|0.01|TWO_SIDED|95.0|0.6|0.84|||Poisson Regression||The numerator represents the DAA group while the denominator represents the comparison group for the rate ratio.|||0.84|0.60|<0.01
70865719|NCT03423641|141217132|SUPERIORITY||Rate Ratio|0.82|||<|0.01|TWO_SIDED|95.0|0.77|0.87|||Poisson Regression||The numerator represents the DAA group while the denominator represents the comparison group for the rate ratio.|||0.87|0.77|<0.01
70948568|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.1||||0.9997|TWO_SIDED|95.0|0.3|4.7|||ANOVA|||Day 56||4.7|0.3|0.9997
70948569|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.5||||0.9287|TWO_SIDED|95.0|0.3|7.2|||ANOVA|||Day 56||7.2|0.3|0.9287
70865720|NCT03423641|141217133|SUPERIORITY||Odds Ratio (OR)|0.47||||0.02|TWO_SIDED|95.0|0.25|0.88|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||0.88|0.25|0.02
70865721|NCT03423641|141217134|SUPERIORITY||Odds Ratio (OR)|0.62||||0.07|TWO_SIDED|95.0|0.37|1.03|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||1.03|0.37|0.07
70865722|NCT03423641|141217135|SUPERIORITY||Odds Ratio (OR)|0.81||||0.11|TWO_SIDED|95.0|0.63|1.05|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||1.05|0.63|0.11
70865723|NCT01788046|141217168|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|30.8|||<|0.001|TWO_SIDED|95.0|18.18|52.17|||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel test stratified by screening PTH category (\< 600, ≥ 600 to ≤ 1000, and \> 1000 pg/mL), recent cinacalcet use within 8 weeks before randomization (yes and no), and region (North America and non-North America) was used to compare the primary endpoint of percentage of participants with \> 30% reduction from baseline in PTH during the EAP between etelcalcetide and placebo.||52.17|18.18|< 0.001
70865724|NCT01788046|141217169|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|33.92|||<|0.001|TWO_SIDED|95.0|16.35|70.37|||Cochran-Mantel-Haenszel|Stratified by screening PTH category, prior cinacalcet use within 8 weeks prior to randomization, and region.||||70.37|16.35|< 0.001
70865725|NCT01788046|141217170|SUPERIORITY_OR_OTHER||Mean Difference|-71.34|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-77.53|-65.14|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-65.14|-77.53|< 0.001
70865726|NCT01788046|141217171|SUPERIORITY_OR_OTHER||Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-8.38|-6.03|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-6.03|-8.38|< 0.001
70865727|NCT01788046|141217172|SUPERIORITY_OR_OTHER||Mean Difference|-14.58|STANDARD_ERROR_OF_MEAN|2.07|<|0.001|TWO_SIDED|95.0|-18.65|-10.51|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-10.51|-18.65|< 0.001
70865728|NCT01788046|141217173|SUPERIORITY_OR_OTHER||Mean Difference|-8.04|STANDARD_ERROR_OF_MEAN|2.09|<|0.001|TWO_SIDED|95.0|-12.15|-3.92|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-3.92|-12.15|< 0.001
70865729|NCT03840174|141217180|OTHER||GMT Ratio|77.7|||||TWO_SIDED|95.0|23.9|252.4|||||Geometric Mean Titer (GMT) ratio and 95% CI were estimated using an ANOVA model.|||252.4|23.9|
70865730|NCT00131508|141217193|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change in REE ratio between the placebo and glutamine groups. The study was designed to provide 80% power at an alpha level of 0.05 for this objective. Due to slow accrual, the sample size of 46 participants required to obtain the designed power of the study was not realized.||||0.17
70865731|NCT00131508|141217194|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change of body mass index between the placebo and glutamine groups.||||0.53
70948570|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.5||||0.5598|TWO_SIDED|95.0|0.1|2.0|||ANOVA|||Day 56||2.0|0.1|0.5598
70865732|NCT00131508|141217195|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change in red blood cell glutamine between the placebo and glutamine groups.||||0.24
70865733|NCT00131508|141217196|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline parent reported physical function in the placebo and glutamine groups.||||0.62
70865734|NCT00131508|141217196|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline parent reported emotional function in the placebo and glutamine groups.||||0.14
70865735|NCT00131508|141217196|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline parent reported social function in the placebo and glutamine groups.||||0.20
70865736|NCT00131508|141217196|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline parent reported school function in the placebo and glutamine groups.||||0.62
70948571|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|3.0||||0.2117|TWO_SIDED|95.0|0.7|13.1|||ANOVA|||Day 56||13.1|0.7|0.2117
70948572|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.4||||0.9699|TWO_SIDED|95.0|0.3|6.6|||ANOVA|||Day 56||6.6|0.3|0.9699
71140044|NCT03192176|141778521|SUPERIORITY||LSMean difference|-6.7|STANDARD_ERROR_OF_MEAN|1.91||0.0006|TWO_SIDED|95.0|-10.4|-2.9||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-2.90|-10.40|0.0006
71140045|NCT03192176|141778521|SUPERIORITY||LSMean difference|-6.5|STANDARD_ERROR_OF_MEAN|1.89||0.0006|TWO_SIDED|95.0|-10.27|-2.81||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-2.81|-10.27|0.0006
71140046|NCT03192176|141778521|SUPERIORITY||LSMean difference|-4.5|STANDARD_ERROR_OF_MEAN|1.93||0.021|TWO_SIDED|95.0|-8.27|-0.68||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.68|-8.27|0.0210
71140047|NCT03192176|141778521|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.93||0.0002|TWO_SIDED|95.0|-10.98|-3.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-3.38|-10.98|0.0002
71140048|NCT03192176|141778521|SUPERIORITY||LSMean difference|-7.3|STANDARD_ERROR_OF_MEAN|1.94||0.0002|TWO_SIDED|95.0|-11.12|-3.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-3.49|-11.12|0.0002
71140049|NCT03192176|141778521|SUPERIORITY||LSMean difference|-9.1|STANDARD_ERROR_OF_MEAN|1.97|<|0.0001|TWO_SIDED|95.0|-12.99|-5.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-5.25|-12.99|<0.0001
71140050|NCT03192176|141778521|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|1.96||0.0047|TWO_SIDED|95.0|-9.45|-1.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-1.73|-9.45|0.0047
71140051|NCT03192176|141778521|SUPERIORITY||LSMean difference|-6.5|STANDARD_ERROR_OF_MEAN|1.94||0.0009|TWO_SIDED|95.0|-10.29|-2.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-2.67|-10.29|0.0009
71140052|NCT03192176|141778521|SUPERIORITY||LSMean difference|-6.5|STANDARD_ERROR_OF_MEAN|1.92||0.0008|TWO_SIDED|95.0|-10.28|-2.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-2.71|-10.28|0.0008
71140053|NCT03192176|141778521|SUPERIORITY||LSMean difference|-3.3|STANDARD_ERROR_OF_MEAN|1.93||0.0889|TWO_SIDED|95.0|-7.1|0.51||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.51|-7.10|0.0889
71140054|NCT03192176|141778521|SUPERIORITY||LSMean difference|-5.9|STANDARD_ERROR_OF_MEAN|1.94||0.0023|TWO_SIDED|95.0|-9.76|-2.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-2.13|-9.76|0.0023
71140055|NCT03192176|141778521|SUPERIORITY||LSMean difference|-6.5|STANDARD_ERROR_OF_MEAN|1.94||0.0009|TWO_SIDED|95.0|-10.36|-2.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-2.71|-10.36|0.0009
71140056|NCT03192176|141778521|SUPERIORITY||LSMean difference|-7.5|STANDARD_ERROR_OF_MEAN|1.98||0.0002|TWO_SIDED|95.0|-11.36|-3.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-3.58|-11.36|0.0002
71140057|NCT03192176|141778521|SUPERIORITY||LSMean difference|-4.4|STANDARD_ERROR_OF_MEAN|1.97||0.0255|TWO_SIDED|95.0|-8.3|-0.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.55|-8.30|0.0255
70948573|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.4||||0.446|TWO_SIDED|95.0|0.1|1.8|||ANOVA|||Day 56||1.8|0.1|0.4460
70948574|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.8||||0.292|TWO_SIDED|95.0|0.6|11.9|||ANOVA|||Day 56||11.9|0.6|0.2920
71140058|NCT03192176|141778521|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.94||0.0031|TWO_SIDED|95.0|-9.63|-1.98||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-1.98|-9.63|0.0031
71140059|NCT03192176|141778521|SUPERIORITY||LSMean difference|-5.7|STANDARD_ERROR_OF_MEAN|1.93||0.0037|TWO_SIDED|95.0|-9.45|-1.85||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-1.85|-9.45|0.0037
71140060|NCT03192176|141778521|SUPERIORITY||LSMean difference|-4.0|STANDARD_ERROR_OF_MEAN|1.84||0.0316|TWO_SIDED|95.0|-7.59|-0.35||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.35|-7.59|0.0316
71140061|NCT03192176|141778521|SUPERIORITY||LSMean difference|-5.4|STANDARD_ERROR_OF_MEAN|1.84||0.0036|TWO_SIDED|95.0|-9.02|-1.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.78|-9.02|0.0036
71140062|NCT03192176|141778521|SUPERIORITY||LSMean difference|-6.6|STANDARD_ERROR_OF_MEAN|1.85||0.0004|TWO_SIDED|95.0|-10.23|-2.94||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-2.94|-10.23|0.0004
71140063|NCT03192176|141778521|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.88||0.0001|TWO_SIDED|95.0|-10.93|-3.54||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-3.54|-10.93|0.0001
71140064|NCT03192176|141778521|SUPERIORITY||LSMean difference|-3.7|STANDARD_ERROR_OF_MEAN|1.87||0.0502|TWO_SIDED|95.0|-7.37|0.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.00|-7.37|0.0502
70865737|NCT00131508|141217196|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month parent reported physical function in the placebo and glutamine groups.||||0.61
70948575|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.3||||0.184|TWO_SIDED|95.0|0.1|1.4|||ANOVA|||Day 56||1.4|0.1|0.1840
70948576|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.0||||0.7229|TWO_SIDED|95.0|0.4|9.2|||ANOVA|||Day 56||9.2|0.4|0.7229
70865738|NCT00131508|141217196|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month parent reported emotional function in the placebo and glutamine groups.||||0.65
70865739|NCT00131508|141217196|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month parent reported social function in the placebo and glutamine groups.||||0.55
70865740|NCT00131508|141217196|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month parent reported school function in the placebo and glutamine groups.||||0.69
70865741|NCT00131508|141217196|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline patient reported physical function in the placebo and glutamine groups.||||0.82
70865742|NCT00131508|141217196|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline patient reported emotional function in the placebo and glutamine groups.||||0.99
70865743|NCT00131508|141217196|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline patient reported social function in the placebo and glutamine groups.||||0.30
70865744|NCT00131508|141217196|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline patient reported school function in the placebo and glutamine groups.||||0.24
70948577|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|6.6||||0.0052|TWO_SIDED|95.0|1.5|28.6|||ANOVA|||Day 56||28.6|1.5|0.0052
70948578|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.8||||0.9777|TWO_SIDED|95.0|0.2|3.0|||ANOVA|||Day 182||3.0|0.2|0.9777
70948579|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.3||||0.9812|TWO_SIDED|95.0|0.3|5.3|||ANOVA|||Day 182||5.3|0.3|0.9812
71140065|NCT03192176|141778521|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|1.85||0.0025|TWO_SIDED|95.0|-9.28|-1.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.99|-9.28|0.0025
71140066|NCT03192176|141778521|SUPERIORITY||LSMean difference|-5.1|STANDARD_ERROR_OF_MEAN|1.84||0.0063|TWO_SIDED|95.0|-8.67|-1.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.44|-8.67|0.0063
71140067|NCT03192176|141778521|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|1.9||0.0117|TWO_SIDED|95.0|-8.58|-1.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-1.08|-8.58|0.0117
71140068|NCT03192176|141778521|SUPERIORITY||LSMean difference|-5.4|STANDARD_ERROR_OF_MEAN|1.91||0.0047|TWO_SIDED|95.0|-9.17|-1.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-1.67|-9.17|0.0047
71140069|NCT03192176|141778521|SUPERIORITY||LSMean difference|-7.0|STANDARD_ERROR_OF_MEAN|1.92||0.0003|TWO_SIDED|95.0|-10.8|-3.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-3.23|-10.80|0.0003
71140070|NCT03192176|141778521|SUPERIORITY||LSMean difference|-7.7|STANDARD_ERROR_OF_MEAN|1.94|<|0.0001|TWO_SIDED|95.0|-11.51|-3.86||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-3.86|-11.51|<0.0001
71140071|NCT03192176|141778521|SUPERIORITY||LSMean difference|-5.2|STANDARD_ERROR_OF_MEAN|1.94||0.0083|TWO_SIDED|95.0|-8.97|-1.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 10||-1.34|-8.97|0.0083
71140072|NCT03192176|141778521|SUPERIORITY||LSMean difference|-6.3|STANDARD_ERROR_OF_MEAN|1.92||0.0011|TWO_SIDED|95.0|-10.1|-2.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-2.56|-10.10|0.0011
71140073|NCT03192176|141778521|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.9||0.0017|TWO_SIDED|95.0|-9.77|-2.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-2.29|-9.77|0.0017
71140074|NCT03192176|141778521|SUPERIORITY||LSMean difference|-4.7|STANDARD_ERROR_OF_MEAN|1.86||0.0119|TWO_SIDED|95.0|-8.37|-1.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.05|-8.37|0.0119
71140075|NCT03192176|141778521|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.86||0.0015|TWO_SIDED|95.0|-9.61|-2.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-2.29|-9.61|0.0015
71140076|NCT03192176|141778521|SUPERIORITY||LSMean difference|-7.7|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|-11.38|-3.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-3.99|-11.38|<0.0001
71140077|NCT03192176|141778521|SUPERIORITY||LSMean difference|-7.6|STANDARD_ERROR_OF_MEAN|1.9|<|0.0001|TWO_SIDED|95.0|-11.33|-3.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-3.87|-11.33|<0.0001
70865745|NCT00131508|141217196|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month patient reported physical function in the placebo and glutamine groups.||||0.50
71140078|NCT03192176|141778521|SUPERIORITY||LSMean difference|-5.3|STANDARD_ERROR_OF_MEAN|1.89||0.0051|TWO_SIDED|95.0|-9.07|-1.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.62|-9.07|0.0051
71140079|NCT03192176|141778521|SUPERIORITY||LSMean difference|-6.6|STANDARD_ERROR_OF_MEAN|1.87||0.0004|TWO_SIDED|95.0|-10.33|-2.96||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-2.96|-10.33|0.0004
71140080|NCT03192176|141778521|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.86||0.0014|TWO_SIDED|95.0|-9.64|-2.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-2.34|-9.64|0.0014
71140081|NCT03192176|141778521|SUPERIORITY||LSMean difference|-5.1|STANDARD_ERROR_OF_MEAN|1.82||0.0054|TWO_SIDED|95.0|-8.67|-1.51||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-1.51|-8.67|0.0054
70865746|NCT00131508|141217196|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month patient reported emotional function in the placebo and glutamine groups.||||0.45
70865747|NCT00131508|141217196|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month patient reported social function in the placebo and glutamine groups.||||0.46
70865748|NCT00131508|141217196|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month patient reported school function in the placebo and glutamine groups.||||0.84
71140082|NCT03192176|141778521|SUPERIORITY||LSMean difference|-6.1|STANDARD_ERROR_OF_MEAN|1.82||0.0008|TWO_SIDED|95.0|-9.71|-2.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-2.55|-9.71|0.0008
71140083|NCT03192176|141778521|SUPERIORITY||LSMean difference|-7.6|STANDARD_ERROR_OF_MEAN|1.84|<|0.0001|TWO_SIDED|95.0|-11.2|-3.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-3.97|-11.20|<0.0001
70865749|NCT00131508|141217197|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in height Z-Score betweeen baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.||||0.20
70865750|NCT00131508|141217197|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in height Z-Score betweeen baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.||||0.81
70865751|NCT00131508|141217197|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||Wilcoxon (Mann-Whitney)|||We tested the null hypothesis that the median difference in height Z-Score betweeen baseline and 12 months differs between the Glutamine and Placebo groups.||||0.70
70865752|NCT00131508|141217198|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in height percentile between baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.||||0.69
70865753|NCT00131508|141217198|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in height percentile between baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.||||0.75
70865754|NCT00131508|141217198|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||Wilcoxon (Mann-Whitney)|||We test the null hypothesis that the median difference in height percentile between baseline and 12 months differs between the Glutamine and Placebo groups.||||0.93
70865755|NCT00131508|141217199|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in weight percentile between baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.||||0.56
70865756|NCT00131508|141217199|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in weight percentile between baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.||||1.0
71140084|NCT03192176|141778521|SUPERIORITY||LSMean difference|-8.2|STANDARD_ERROR_OF_MEAN|1.85|<|0.0001|TWO_SIDED|95.0|-11.88|-4.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-4.59|-11.88|<0.0001
71140085|NCT03192176|141778521|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|1.85||0.0026|TWO_SIDED|95.0|-9.27|-1.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-1.99|-9.27|0.0026
70865757|NCT00131508|141217199|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Wilcoxon (Mann-Whitney)|||We test the null hypothesis that the median difference in weight percentile between baseline and 12 months differs between the Glutamine and Placebo groups.||||0.61
70865758|NCT00131508|141217200|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change in pulse rate between the placebo and glutamine groups.||||0.83
71140086|NCT03192176|141778521|SUPERIORITY||LSMean difference|-6.8|STANDARD_ERROR_OF_MEAN|1.83||0.0003|TWO_SIDED|95.0|-10.35|-3.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-3.16|-10.35|0.0003
71140087|NCT03192176|141778521|SUPERIORITY||LSMean difference|-6.3|STANDARD_ERROR_OF_MEAN|1.81||0.0006|TWO_SIDED|95.0|-9.88|-2.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-2.75|-9.88|0.0006
71140088|NCT03192176|141778521|SUPERIORITY||LSMean difference|-5.3|STANDARD_ERROR_OF_MEAN|2.12||0.0126|TWO_SIDED|95.0|-9.48|-1.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-1.15|-9.48|0.0126
71140089|NCT03192176|141778521|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|2.12||0.1724|TWO_SIDED|95.0|-7.06|1.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMMRM|||Week 13||1.27|-7.06|0.1724
71140090|NCT03192176|141778521|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|2.18||0.3548|TWO_SIDED|95.0|-6.31|2.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||2.27|-6.31|0.3548
71140091|NCT03192176|141778521|SUPERIORITY||LSMean difference|-3.8|STANDARD_ERROR_OF_MEAN|2.18||0.086|TWO_SIDED|95.0|-8.04|0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|LSMean difference|||Week 13||0.53|-8.04|0.0860
71140092|NCT03192176|141778521|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|2.19||0.0111|TWO_SIDED|95.0|-9.89|-1.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-1.28|-9.89|0.0111
71140093|NCT03192176|141778521|SUPERIORITY||LSMean difference|-4.6|STANDARD_ERROR_OF_MEAN|2.19||0.0349|TWO_SIDED|95.0|-8.94|-0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.33|-8.94|0.0349
71140094|NCT03192176|141778521|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|2.12||0.2205|TWO_SIDED|95.0|-6.77|1.57||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||1.57|-6.77|0.2205
70865759|NCT00131508|141217201|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change in hand grip between the placebo and glutamine groups.||||0.40
70865760|NCT01479127|141217207|SUPERIORITY_OR_OTHER|||||||0.058|TWO_SIDED||||||Paired t-test|||"TRS I OFF state"||||0.058
70865761|NCT01479127|141217207|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Paired t-test|||"TRS I Dyskinesia state"||||1.000
70865762|NCT01479127|141217207|SUPERIORITY_OR_OTHER|||||||0.153|TWO_SIDED||||||Paired t-test|||"TRS II Normal state"||||0.153
70865763|NCT01479127|141217207|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||Paired t-test|||"TRS II OFF state"||||0.140
71140095|NCT03192176|141778521|SUPERIORITY||LSMean differencce|-4.0|STANDARD_ERROR_OF_MEAN|2.17||0.0645|TWO_SIDED|95.0|-8.29|0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.24|-8.29|0.0645
71140096|NCT03192176|141778521|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|2.16||0.5031|TWO_SIDED|95.0|-5.69|2.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||2.80|-5.69|0.5031
71140097|NCT03192176|141778521|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|2.24||0.5263|TWO_SIDED|95.0|-5.84|2.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||2.99|-5.84|0.5263
71140098|NCT03192176|141778521|SUPERIORITY||LSMean differencce|-2.4|STANDARD_ERROR_OF_MEAN|2.24||0.2782|TWO_SIDED|95.0|-6.83|1.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.97|-6.83|0.2782
70865764|NCT01479127|141217207|SUPERIORITY_OR_OTHER|||||||0.374|TWO_SIDED||||||Paired t-test|||"TRS II Dyskinesia state"||||0.374
70865765|NCT01479127|141217208|SUPERIORITY_OR_OTHER|||||||0.574|TWO_SIDED||||||Paired t-test|||||||0.574
70865766|NCT01479127|141217208|SUPERIORITY_OR_OTHER|||||||0.661|TWO_SIDED||||||Paired t-test|||ON time w/o D + time with NTD||||0.661
70865767|NCT01479127|141217208|SUPERIORITY_OR_OTHER|||||||0.574|TWO_SIDED||||||Paired t-test|||ON time w/o D + time with NTD + time w/ TD||||0.574
70865768|NCT01479127|141217209|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Wilcoxon one-sample test|||Rapid alternating movement of hands||||0.500
70865769|NCT01479127|141217209|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon one-sample test|||Arising from chair||||1.000
70865770|NCT01479127|141217209|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Wilcoxon one-sample test|||Postural stability||||0.250
70865771|NCT01479127|141217209|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Wilcoxon one-sample test|||Body bradykinesia and hypokinesia||||0.500
70865772|NCT01479127|141217209|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Wilcoxon one-sample test|||Dyskinesia||||0.250
70865773|NCT01479127|141217210|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Paired t-test|||Total score||||0.870
70865774|NCT01479127|141217210|SUPERIORITY_OR_OTHER|||||||0.374|TWO_SIDED||||||Paired t-test|||Part I||||0.374
70865775|NCT01479127|141217210|SUPERIORITY_OR_OTHER|||||||0.799|TWO_SIDED||||||Paired t-test|||Part II||||0.799
70865776|NCT01479127|141217210|SUPERIORITY_OR_OTHER|||||||0.493|TWO_SIDED||||||Paired t-test|||Part II (Off-time)||||0.493
70865777|NCT01479127|141217210|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||Paired t-test|||Part III||||0.530
70865778|NCT01479127|141217210|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED||||||Paired t-test|||Part IV sub-score of dyskinesia||||0.108
70865779|NCT01479127|141217211|SUPERIORITY_OR_OTHER|||||||0.636|TWO_SIDED||||||Paired t-test|||Total score||||0.636
70865780|NCT01479127|141217211|SUPERIORITY_OR_OTHER|||||||0.329|TWO_SIDED||||||Paired t-test|||Domain: Mobility||||0.329
70865781|NCT01479127|141217211|SUPERIORITY_OR_OTHER|||||||0.902|TWO_SIDED||||||Paired t-test|||Domain: Activities of daily living||||0.902
70865782|NCT01479127|141217211|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Paired t-test|||Domain: Emotional well-being||||0.220
70865783|NCT01479127|141217211|SUPERIORITY_OR_OTHER|||||||0.799|TWO_SIDED||||||Paired t-test|||Domain: Stigma||||0.799
70865784|NCT01479127|141217211|SUPERIORITY_OR_OTHER|||||||0.178|TWO_SIDED||||||Paired t-test|||Domain: Social support||||0.178
70865785|NCT01479127|141217211|SUPERIORITY_OR_OTHER|||||||0.456|TWO_SIDED||||||Paired t-test|||Domain: Cognition||||0.456
70865786|NCT01479127|141217211|SUPERIORITY_OR_OTHER|||||||0.866|TWO_SIDED||||||Paired t-test|||Domain: Communication||||0.866
70865787|NCT01479127|141217211|SUPERIORITY_OR_OTHER|||||||0.576|TWO_SIDED||||||Paired t-test|||Domain: Bodily discomfort||||0.576
70865788|NCT01479127|141217212|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon one-sample test|||"On state staging"||||1.000
70865789|NCT01479127|141217212|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon one-sample test|||"Off state staging"||||1.000
70865790|NCT01479127|141217213|SUPERIORITY_OR_OTHER|||||||0.125|TWO_SIDED||||||Wilcoxon one-sample test|||||||0.125
70865791|NCT01479127|141217218|SUPERIORITY_OR_OTHER|||||||0.074|TWO_SIDED||||||Paired t-test|||||||0.074
70865792|NCT03569033|141217226|OTHER||Difference in Least Squares Means|-0.32||||0.748|TWO_SIDED|95.0|-2.29|1.66|||Longitudinal Data Analysis|||||1.66|-2.29|0.748
70865793|NCT03569033|141217227|OTHER||Difference in Least Squares Means|0.99||||0.754|TWO_SIDED|95.0|-5.33|7.3|||ANCOVA|||||7.30|-5.33|0.754
70865794|NCT03569033|141217228|OTHER||Difference in Least Squares Means|0.8||||0.627|TWO_SIDED|95.0|-2.5|4.1|||ANCOVA|||||4.10|-2.50|0.627
70865795|NCT03569033|141217229|OTHER||Difference in Least Squares Means|0.09||||0.631|TWO_SIDED|95.0|-0.28|0.45|||ANCOVA|||||0.45|-0.28|0.631
70865796|NCT03072732|141217258|NON_INFERIORITY|The µ-Cor System will be considered non-inferior with respect to clinical performance (i.e., trends in fluid change) of the ZOE device if the lower 95% confidence interval of the differences (Primary Measurement) is greater than the non-inferiority margin of -0.05.|Mean Difference (Final Values)|0.66|||||TWO_SIDED|95.0|0.57|0.75|||||"Because the distribution was skewed, the average was calculated by 1) Fisher Transformation of values, 2) averaging the transformed values, 3) back calculating the mean.~The Taylor Series expansion and Delta method was used to determine variance."|"The null hypothesis was that the correlation coefficient of the ZOE device would be greater than the correlation coefficient of the uCor device by at least 0.05.~For each subject, a correlation coefficient was calculated between study arm 1 uCor readings and UFV, as well as ZOE readings and UFV.~The difference between uCor correlation coefficient and ZOE correlation coefficient for each subject was used as the Primary Measurement."||0.75|0.57|
70865797|NCT03072732|141217258|NON_INFERIORITY|The µ-Cor System will be considered non-inferior with respect to clinical performance (i.e., trends in fluid change) of the ZOE device if the lower 95% confidence interval of the differences (Primary Measurement) is greater than the non-inferiority margin of -0.05.|Mean Difference (Final Values)|0.23|||||TWO_SIDED|95.0|0.12|0.35|||||"Because the distribution was skewed, the average was calculated by 1) Fisher Transformation of values, 2) averaging the transformed values, 3) back calculating the mean.~The Taylor Series expansion and Delta method was used to determine variance."|"The null hypothesis was that the correlation coefficient of the ZOE device would be greater than the correlation coefficient of the uCor device by at least 0.05.~For each subject, a correlation coefficient was calculated between study arm 2 uCor readings and UFV, as well as ZOE readings and UFV.~The difference between uCor correlation coefficient and ZOE correlation coefficient for each subject was used as the Primary Measurement."||0.35|0.12|
70865798|NCT04402060|141217262|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.82|TWO_SIDED|90.0|0.63|1.51|||Log Rank|||P-value was from a 2-sided stratified Log-rank test by the randomization stratification factors (need of mechanical ventilation \[yes vs no\] and age \[\<65 years vs ≥65 years\]) at 0.1 significant level for evaluation of treatment difference. Hazard ratio was obtained from a Cox regression model with treatment and the randomization stratification factors as fixed factors and 90% confidence interval (CI) was based on the Wald method.||1.51|0.63|0.82
70865799|NCT04402060|141217263|SUPERIORITY||Hazard Ratio (HR)|1.62||||0.36|TWO_SIDED|90.0|0.77|3.4|||Log Rank|||P-value was from a 2-sided stratified Log-rank test by the randomization stratification factors (need of mechanical ventilation \[yes vs no\] and age \[\<65 years vs ≥65 years\]) at 0.1 significant level for evaluation of treatment difference. Hazard ratio was obtained from a Cox regression model with treatment and the randomization stratification factors as fixed factors and 90% CI was based on the Wald method.||3.40|0.77|0.36
70865800|NCT04402060|141217265|SUPERIORITY||Hazard Ratio (HR)|0.09||||0.03|TWO_SIDED|90.0|0.01|0.51|||Log Rank|||P-value was from a 2-sided stratified Log-rank test by the randomization stratification factors (need of mechanical ventilation \[yes vs no\] and age \[\<65 years vs ≥65 years\]) at 0.1 significant level for evaluation of treatment difference. Hazard ratio was obtained from a Cox regression model with treatment and the randomization stratification factors as fixed factors and 90% CI was based on the Wald method.||0.51|0.01|0.03
71140099|NCT03192176|141778521|SUPERIORITY||LSMean difference|-5.3|STANDARD_ERROR_OF_MEAN|2.24||0.0198|TWO_SIDED|95.0|-9.67|-0.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.84|-9.67|0.0198
71140100|NCT03192176|141778521|SUPERIORITY||LSMean difference|-4.6|STANDARD_ERROR_OF_MEAN|2.25||0.0417|TWO_SIDED|95.0|-9.05|-0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.18|-9.05|0.0417
71140101|NCT03192176|141778521|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|2.16||0.2963|TWO_SIDED|95.0|-6.52|2.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||2.00|-6.52|0.2963
71140102|NCT03192176|141778521|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|2.09||0.5408|TWO_SIDED|95.0|-5.39|2.83||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||2.83|-5.39|0.5408
71140103|NCT03192176|141778521|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|2.07||0.7473|TWO_SIDED|95.0|-4.74|3.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||3.41|-4.74|0.7473
71140104|NCT03192176|141778521|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|2.18||0.9214|TWO_SIDED|95.0|-4.07|4.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||4.50|-4.07|0.9214
71140105|NCT03192176|141778521|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|2.14||0.9876|TWO_SIDED|95.0|-4.19|4.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||4.26|-4.19|0.9876
71140106|NCT03192176|141778521|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|2.18||0.2379|TWO_SIDED|95.0|-6.86|1.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.71|-6.86|0.2379
71140107|NCT03192176|141778521|SUPERIORITY||LSMean difference|-3.2|STANDARD_ERROR_OF_MEAN|2.18||0.1491|TWO_SIDED|95.0|-7.45|1.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.14|-7.45|0.1491
71140108|NCT03192176|141778521|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|2.07||0.956|TWO_SIDED|95.0|-3.96|4.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||4.19|-3.96|0.9560
71140109|NCT03192176|141778522|SUPERIORITY||LSMean difference|-5.2|STANDARD_ERROR_OF_MEAN|1.96||0.0089|TWO_SIDED|95.0|-9.01|-1.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.30|-9.01|0.0089
71140110|NCT03192176|141778522|SUPERIORITY||LSMean difference|-8.4|STANDARD_ERROR_OF_MEAN|1.97|<|0.0001|TWO_SIDED|95.0|-12.22|-4.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-4.48|-12.22|<0.0001
70948580|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.2||||0.9979|TWO_SIDED|95.0|0.3|4.5|||ANOVA|||Day 182||4.5|0.3|0.9979
70948581|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.0||||0.588|TWO_SIDED|95.0|0.5|7.9|||ANOVA|||Day 182||7.9|0.5|0.5880
70865801|NCT04402060|141217266|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.93|TWO_SIDED|90.0|0.69|1.72|||Log Rank|||P-value was from a 2-sided stratified Log-rank test by the randomization stratification factors (need of mechanical ventilation \[yes vs no\] and age \[\<65 years vs ≥65 years\]) at 0.1 significant level for evaluation of treatment difference. Hazard ratio was obtained from a Cox regression model with treatment and the randomization stratification factors as fixed factors and 90% CI was based on the Wald method.||1.72|0.69|0.93
70865802|NCT02256072|141217279|SUPERIORITY_OR_OTHER||Slope|1.25|STANDARD_ERROR_OF_MEAN|0.45||0.0054|TWO_SIDED|95.0|0.37|2.12|||ANCOVA|||H1: Compared to participants in the attention control group and controlling for baseline assessments, participants receiving the PLAN YOUR LIFESPAN tool will show increased planning with regard to planning behavior score (measured via the Planning Assessment tool) one (efficacy) month after intervention.||2.12|0.37|0.0054
70865803|NCT02256072|141217280|SUPERIORITY_OR_OTHER||Slope|0.244|STANDARD_ERROR_OF_MEAN|0.123||0.0471|TWO_SIDED|||||P-value controlled for significant baseline covariates (sex, importance of religion, stroke, and self efficacy score) and individual participant effect.|Mixed Models Analysis|The p-value is based on the slope estimation provided below.||Secondary analyses will compare baseline variables (current utilization of services, physical function assessment, co-morbidities, social support, health literacy, self-efficacy, and sociodemographics) with outcome (one-at-a-time). Those found to have a significant association with outcome will be included in a linear mixed model, with random effect for intercept. A backward stepwise model building process will be used to determine an overall parsimonious model for outcome.||||0.0471
70865804|NCT02256072|141217281|SUPERIORITY_OR_OTHER||Slope|0.075|STANDARD_ERROR_OF_MEAN|0.094||0.423|TWO_SIDED|||||p-value controlled for significant baseline covariates (confidence in using the internet, self efficacy score, support score, and race/ethnicity.|Mixed Models Analysis|The p-value is based on the slope estimation provided below.|The score is the equally-weighted sum of responses to the five questions in the CAHS instrument. Each question has a scale of 1-5, with a total possible range of 5-25. No subscores are calculated.|H2: Compared to participants in the attention control group and controlling for baseline assessments, participants receiving the PLAN YOUR LIFESPAN tool will show increased confidence in accessing home services (measured via the Confidence in Accessing Home Services tool) one (efficacy) and three (effect retention) months after intervention.||||0.423
70865805|NCT02256072|141217282|SUPERIORITY_OR_OTHER||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|||||p-value controlled for significant baseline covariates (sex, income, health literacy, education level, high blood pressure, and kidney disease) and individual participant effect.|Mixed Models Analysis|The p-value is based on the slope estimation provided below.||Compared to participants in the attention control group, participants receiving PLAN YOUR LIFESPAN will show increased UHS 1 (efficacy) and 3 (effect retention) months post-intervention. Secondary analyses will compare baseline variables with outcome (one-at-a-time). Those with a significant association with outcome will be included in a LMM for UHS, with random effect for intercept. A backward stepwise model building process will be used to determine an overall parsimonious model for UHS.||||<0.0001
70865806|NCT01313858|141217352|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 3 (Month 3 minus BL)||||0.0007
70865807|NCT01313858|141217352|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 6 (Month 6 minus BL)||||0.0007
70865808|NCT01313858|141217352|SUPERIORITY_OR_OTHER|||||||0.0011|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 9 (Month 9 minus BL)||||0.0011
70865809|NCT01313858|141217352|SUPERIORITY_OR_OTHER|||||||0.0015|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 12 (Month 12 minus BL)||||0.0015
70865810|NCT01313858|141217352|SUPERIORITY_OR_OTHER|||||||0.0029|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 15 (Month 15 minus BL)||||0.0029
70865811|NCT01313858|141217352|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 18 (Month 18 minus BL)||||0.0004
70865812|NCT01313858|141217352|SUPERIORITY_OR_OTHER|||||||0.0059|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 21 (Month 21 minus BL)||||0.0059
70865813|NCT01313858|141217352|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 24 (Month 24 minus BL)||||0.0002
70865814|NCT01313858|141217352|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 3 (Month 3 minus BL)||||0.0002
70865815|NCT01313858|141217352|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 6 (Month 6 minus BL)||||<0.0001
71140111|NCT03192176|141778522|SUPERIORITY||LSMean difference|-9.2|STANDARD_ERROR_OF_MEAN|1.96|<|0.0001|TWO_SIDED|95.0|-13.06|-5.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-5.34|-13.06|<0.0001
70865816|NCT01313858|141217352|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 9 (Month 9 minus BL)||||<0.0001
70865817|NCT01313858|141217352|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 12 (Month 12 minus BL)||||<0.0001
70865818|NCT01313858|141217352|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 15 (Month 15 minus BL)||||0.0002
70865819|NCT01313858|141217352|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 18 (Month 18 minus BL)||||<0.0001
70865820|NCT01313858|141217352|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 21 (Month 21 minus BL)||||<0.0001
70865821|NCT01313858|141217352|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 24 (Month 24 minus BL)||||<0.0001
70865822|NCT01313858|141217352|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 3 (Month 3 minus BL)||||<0.0001
70865823|NCT01313858|141217352|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 6 (Month 6 minus BL)||||<0.0001
70948582|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.7||||0.7973|TWO_SIDED|95.0|0.4|7.0|||ANOVA|||Day 182||7.0|0.4|0.7973
70948583|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.5||||0.8992|TWO_SIDED|95.0|0.4|6.0|||ANOVA|||Day 182||6.0|0.4|0.8992
70865824|NCT01313858|141217352|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 9 (Month 9 minus BL)||||<0.0001
70865825|NCT01313858|141217352|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 12 (Month 12 minus BL)||||<0.0001
70865826|NCT01313858|141217352|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 15 (Month 15 minus BL)||||<0.0001
70865827|NCT01313858|141217352|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 18 (Month 18 minus BL)||||<0.0001
70865828|NCT01313858|141217352|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 21 (Month 21 minus BL)||||<0.0001
70865829|NCT01313858|141217352|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 24 (Month 24 minus BL)||||<0.0001
70865830|NCT01313858|141217353|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 3 (Month 3 minus BL)||||0.0003
71140112|NCT03192176|141778522|SUPERIORITY||LSMean difference|-10.7|STANDARD_ERROR_OF_MEAN|1.99|<|0.0001|TWO_SIDED|95.0|-14.58|-6.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-6.75|-14.58|<0.0001
71140113|NCT03192176|141778522|SUPERIORITY||LSMean difference|-3.7|STANDARD_ERROR_OF_MEAN|2.0||0.063|TWO_SIDED|95.0|-7.65|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||0.20|-7.65|0.0630
71140114|NCT03192176|141778522|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.97||0.0003|TWO_SIDED|95.0|-11.04|-3.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-3.30|-11.04|0.0003
71140115|NCT03192176|141778522|SUPERIORITY||LSMean difference|-6.7|STANDARD_ERROR_OF_MEAN|1.96||0.0007|TWO_SIDED|95.0|-10.53|-2.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-2.84|-10.53|0.0007
71140116|NCT03192176|141778522|SUPERIORITY||LSMean difference|-4.5|STANDARD_ERROR_OF_MEAN|1.98||0.0231|TWO_SIDED|95.0|-8.43|-0.63||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.63|-8.43|0.0231
71140117|NCT03192176|141778522|SUPERIORITY||LSMean difference|-8.0|STANDARD_ERROR_OF_MEAN|1.99|<|0.0001|TWO_SIDED|95.0|-11.94|-4.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-4.09|-11.94|<0.0001
71140118|NCT03192176|141778522|SUPERIORITY||LSMean differencce|-8.0|STANDARD_ERROR_OF_MEAN|1.99|<|0.0001|TWO_SIDED|95.0|-11.87|-4.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-4.05|-11.87|<0.0001
71140119|NCT03192176|141778522|SUPERIORITY||LSMean difference|-9.2|STANDARD_ERROR_OF_MEAN|2.02|<|0.0001|TWO_SIDED|95.0|-13.21|-5.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-5.26|-13.21|<0.0001
71140120|NCT03192176|141778522|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|2.02||0.0177|TWO_SIDED|95.0|-8.8|-0.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.84|-8.80|0.0177
71140121|NCT03192176|141778522|SUPERIORITY||LSMean difference|-6.5|STANDARD_ERROR_OF_MEAN|1.99||0.0012|TWO_SIDED|95.0|-10.45|-2.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-2.60|-10.45|0.0012
71140122|NCT03192176|141778522|SUPERIORITY||LSMean difference|-6.6|STANDARD_ERROR_OF_MEAN|2.04||0.0072|TWO_SIDED|95.0|-9.26|-2.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-2.64|-9.26|0.0072
71140123|NCT03192176|141778522|SUPERIORITY||LSMean difference|-5.9|STANDARD_ERROR_OF_MEAN|2.04||0.0044|TWO_SIDED|95.0|-9.86|-1.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.84|-9.86|0.0044
71140124|NCT03192176|141778522|SUPERIORITY||LSMean difference|-9.2|STANDARD_ERROR_OF_MEAN|2.05|<|0.0001|TWO_SIDED|95.0|-13.27|-5.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-5.21|-13.27|<0.0001
71140125|NCT03192176|141778522|SUPERIORITY||LSMean difference|-8.6|STANDARD_ERROR_OF_MEAN|2.04|<|0.0001|TWO_SIDED|95.0|-12.57|-4.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-4.55|-12.57|<0.0001
71140126|NCT03192176|141778522|SUPERIORITY||LSMean difference|-10.2|STANDARD_ERROR_OF_MEAN|2.08|<|0.0001|TWO_SIDED|95.0|-14.29|-6.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-6.11|-14.29|<0.0001
71140127|NCT03192176|141778522|SUPERIORITY||LSMean difference|-7.0|STANDARD_ERROR_OF_MEAN|2.08||0.0009|TWO_SIDED|95.0|-11.04|-2.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-2.87|-11.04|0.0009
71140128|NCT03192176|141778522|SUPERIORITY||LSMean difference|-8.4|STANDARD_ERROR_OF_MEAN|2.05|<|0.0001|TWO_SIDED|95.0|-12.44|-4.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-4.39|-12.44|<0.0001
70865831|NCT01313858|141217353|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 6 (Month 6 minus BL)||||<0.0001
70865832|NCT01313858|141217353|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 12 (Month 12 minus BL)||||<0.0001
70865833|NCT01313858|141217353|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 18 (Month 18 minus BL)||||<0.0001
70865834|NCT01313858|141217353|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 24 (Month 24 minus BL)||||<0.0001
70865835|NCT01313858|141217353|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 3 (Month 3 minus BL)||||<0.0001
70865836|NCT01313858|141217353|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 6 (Month 6 minus BL)||||<0.0001
70865837|NCT01313858|141217353|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 12 (Month 12 minus BL)||||<0.0001
70865838|NCT01313858|141217353|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 18 (Month 18 minus BL)||||<0.0001
70948584|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.7||||0.2602|TWO_SIDED|95.0|0.7|10.4|||ANOVA|||Day 182||10.4|0.7|0.2602
70865839|NCT01313858|141217353|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 24 (Month 24 minus BL)||||<0.0001
70865840|NCT01313858|141217353|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 3 (Month 3 minus BL)||||<0.0001
71140129|NCT03192176|141778522|SUPERIORITY||LSMean difference|-6.6|STANDARD_ERROR_OF_MEAN|2.04||0.0012|TWO_SIDED|95.0|-10.65|-2.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-2.64|-10.65|0.0012
70865841|NCT01313858|141217353|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 6 (Month 6 minus BL)||||<0.0001
70865842|NCT01313858|141217353|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 12 (Month 12 minus BL)||||<0.0001
70865843|NCT01313858|141217353|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 18 (Month 18 minus BL)||||<0.0001
70865844|NCT01313858|141217353|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 24 (Month 24 minus BL)||||<0.0001
70865845|NCT01313858|141217354|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 6 (Month 6 minus BL)||||<0.0001
70865846|NCT01313858|141217354|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 12 (Month 12 minus BL)||||<0.0001
70865847|NCT01313858|141217354|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 18 (Month 18 minus BL)||||<0.0001
70865848|NCT01313858|141217354|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 24 (Month 24 minus BL)||||<0.0001
70865849|NCT01313858|141217354|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 6 (Month 6 minus BL)||||<0.0001
70865850|NCT01313858|141217354|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 12 (Month 12 minus BL)||||<0.0001
70865851|NCT01313858|141217354|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 18 (Month 18 minus BL)||||<0.0001
70865852|NCT01313858|141217354|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 24 (Month 24 minus BL)||||<0.0001
70865853|NCT01313858|141217354|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 6 (Month 6 minus BL)||||<0.0001
70865854|NCT01313858|141217354|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 12 (Month 12 minus BL)||||<0.0001
70865855|NCT01313858|141217354|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 18 (Month 18 minus BL)||||<0.0001
70865856|NCT01313858|141217354|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 24 (Month 24 minus BL)||||<0.0001
70865857|NCT01935791|141217357|OTHER||||||<|0.01||||||The p-values were adjusted for multiple comparisons. The a priori threshold for statistical significance is p\<0.05.|ANOVA|plus Tukey test||||||<0.01
70865858|NCT01935791|141217358|OTHER||||||<|0.001|||||||ANOVA|plus Tukey test||||||<0.001
70865859|NCT03792191|141217386|SUPERIORITY||Median Difference (Final Values)|0.00007||||0.62|TWO_SIDED|95.0|-0.00005|1.0|||Wilcoxon (Mann-Whitney)|||||1|-0.00005|0.62
70865860|NCT03792191|141217387|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||||||0.58
70865861|NCT03792191|141217388|SUPERIORITY||Risk Difference (RD)|-0.036||||0.6|TWO_SIDED|95.0|-0.15|0.079|||Chi-squared, Corrected|||||0.079|-0.15|0.6
70865862|NCT03792191|141217389|SUPERIORITY||Risk Difference (RD)|-0.021||||0.77|TWO_SIDED|95.0|-0.125|0.082|||Chi-squared, Corrected|||||0.082|-0.125|0.77
70865863|NCT03792191|141217390|SUPERIORITY||Median Difference (Final Values)|8.0||||0.077|TWO_SIDED|95.0|-1.0|20.0|||Wilcoxon (Mann-Whitney)|||||20|-1|0.077
70865864|NCT03792191|141217391|SUPERIORITY||Median Difference (Final Values)|0.00003||||0.1|TWO_SIDED|95.0|-0.00001|0.00003|||Wilcoxon (Mann-Whitney)|||||0.00003|-0.00001|0.1
70948585|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.9||||0.9991|TWO_SIDED|95.0|0.2|3.6|||ANOVA|||Day 182||3.6|0.2|0.9991
71140130|NCT03192176|141778522|SUPERIORITY||LSMean difference|-5.7|STANDARD_ERROR_OF_MEAN|2.04||0.0053|TWO_SIDED|95.0|-9.72|-1.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-1.71|-9.72|0.0053
71140131|NCT03192176|141778522|SUPERIORITY||LSMean difference|-8.8|STANDARD_ERROR_OF_MEAN|2.04|<|0.0001|TWO_SIDED|95.0|-12.77|-4.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-4.73|-12.77|<0.0001
71140132|NCT03192176|141778522|SUPERIORITY||LSMean difference|-7.8|STANDARD_ERROR_OF_MEAN|2.04||0.0001|TWO_SIDED|95.0|-11.84|-3.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-3.84|-11.84|0.0001
71140133|NCT03192176|141778522|SUPERIORITY||LSMean difference|-10.0|STANDARD_ERROR_OF_MEAN|2.07|<|0.0001|TWO_SIDED|95.0|-14.12|-5.96||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-5.96|-14.12|<0.0001
71140134|NCT03192176|141778522|SUPERIORITY||LSMean difference|-6.9|STANDARD_ERROR_OF_MEAN|2.07||0.001|TWO_SIDED|95.0|-10.92|-2.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-2.78|-10.92|0.0010
71140135|NCT03192176|141778522|SUPERIORITY||LSMean difference|-8.5|STANDARD_ERROR_OF_MEAN|2.04|<|0.0001|TWO_SIDED|95.0|-12.49|-4.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-4.46|-12.49|<0.0001
71140136|NCT03192176|141778522|SUPERIORITY||LSMean difference|-7.1|STANDARD_ERROR_OF_MEAN|2.03||0.0005|TWO_SIDED|95.0|-11.12|-3.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-3.13|-11.12|0.0005
71140137|NCT03192176|141778522|SUPERIORITY||LSMean difference|-5.4|STANDARD_ERROR_OF_MEAN|1.93||0.0057|TWO_SIDED|95.0|-9.15|-1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.58|-9.15|0.0057
71140138|NCT03192176|141778522|SUPERIORITY||LSMean difference|-8.4|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED|95.0|-12.15|-4.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-4.56|-12.15|<0.0001
71140139|NCT03192176|141778522|SUPERIORITY||LSMean difference|-7.9|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED|95.0|-11.68|-4.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-4.08|-11.68|<0.0001
71140140|NCT03192176|141778522|SUPERIORITY||LSMean difference|-9.8|STANDARD_ERROR_OF_MEAN|1.96|<|0.0001|TWO_SIDED|95.0|-13.66|-5.93||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-5.93|-13.66|<0.0001
71140141|NCT03192176|141778522|SUPERIORITY||LSMean difference|-6.7|STANDARD_ERROR_OF_MEAN|1.95||0.0007|TWO_SIDED|95.0|-10.54|-2.85||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-2.85|-10.54|0.0007
71140142|NCT03192176|141778522|SUPERIORITY||LSMean difference|-7.7|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED|95.0|-11.55|-3.95||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-3.95|-11.55|<0.0001
71140143|NCT03192176|141778522|SUPERIORITY||LSMean difference|-6.4|STANDARD_ERROR_OF_MEAN|1.92||0.001|TWO_SIDED|95.0|-10.16|-2.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-2.60|-10.16|0.0010
71140144|NCT03192176|141778522|SUPERIORITY||LSMean difference|-5.2|STANDARD_ERROR_OF_MEAN|1.91||0.0064|TWO_SIDED|95.0|-8.99|-1.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.48|-8.99|0.0064
71140145|NCT03192176|141778522|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.91||0.0002|TWO_SIDED|95.0|-10.94|-3.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-3.42|-10.94|0.0002
71140146|NCT03192176|141778522|SUPERIORITY||LSMean difference|-7.5|STANDARD_ERROR_OF_MEAN|1.92||0.0001|TWO_SIDED|95.0|-11.29|-3.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-3.75|-11.29|0.0001
70865865|NCT03792191|141217392|SUPERIORITY||||||>|0.99|||||||Chi-squared, Corrected|||||||>0.99
70865866|NCT03792191|141217393|SUPERIORITY||||||>|0.99|||||||Chi-squared, Corrected|||||||>0.99
71140147|NCT03192176|141778522|SUPERIORITY||LSMean difference|-8.9|STANDARD_ERROR_OF_MEAN|1.95|<|0.0001|TWO_SIDED|95.0|-12.69|-5.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-5.03|-12.69|<0.0001
70948586|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.5||||0.9028|TWO_SIDED|95.0|0.4|6.2|||ANOVA|||Day 182||6.2|0.4|0.9028
71140148|NCT03192176|141778522|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.94||0.003|TWO_SIDED|95.0|-9.62|-1.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.99|-9.62|0.0030
71140149|NCT03192176|141778522|SUPERIORITY||LSMean difference|-7.1|STANDARD_ERROR_OF_MEAN|1.92||0.0002|TWO_SIDED|95.0|-10.92|-3.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-3.37|-10.92|0.0002
71140150|NCT03192176|141778522|SUPERIORITY||LSMean difference|-6.2|STANDARD_ERROR_OF_MEAN|1.9||0.0013|TWO_SIDED|95.0|-9.91|-2.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-2.42|-9.91|0.0013
71140151|NCT03192176|141778522|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|1.94||0.0137|TWO_SIDED|95.0|-8.61|-0.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.99|-8.61|0.0137
71140152|NCT03192176|141778522|SUPERIORITY||LSMean difference|-7.4|STANDARD_ERROR_OF_MEAN|1.94||0.0002|TWO_SIDED|95.0|-11.24|-3.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-3.60|-11.24|0.0002
71140153|NCT03192176|141778522|SUPERIORITY||LSMean difference|-7.0|STANDARD_ERROR_OF_MEAN|1.95||0.0004|TWO_SIDED|95.0|-10.79|-3.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-3.13|-10.79|0.0004
71140154|NCT03192176|141778522|SUPERIORITY||LSMean difference|-8.9|STANDARD_ERROR_OF_MEAN|1.98|<|0.0001|TWO_SIDED|95.0|-12.74|-4.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-4.97|-12.74|<0.0001
71140155|NCT03192176|141778522|SUPERIORITY||LSMean difference|-5.9|STANDARD_ERROR_OF_MEAN|1.97||0.0028|TWO_SIDED|95.0|-9.82|-2.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-2.07|-9.82|0.0028
71140156|NCT03192176|141778522|SUPERIORITY||LSMean difference|-6.8|STANDARD_ERROR_OF_MEAN|1.95||0.0006|TWO_SIDED|95.0|-10.6|-2.94||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-2.94|-10.60|0.0006
71140157|NCT03192176|141778522|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.93||0.002|TWO_SIDED|95.0|-9.82|-2.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-2.21|-9.82|0.0020
71140158|NCT03192176|141778522|SUPERIORITY||LSMean difference|-3.7|STANDARD_ERROR_OF_MEAN|1.93||0.0588|TWO_SIDED|95.0|-7.46|0.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.14|-7.46|0.0588
71140159|NCT03192176|141778522|SUPERIORITY||LSMean difference|-3.7|STANDARD_ERROR_OF_MEAN|1.93||0.0018|TWO_SIDED|95.0|-9.9|0.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.14|-9.90|0.0018
71140160|NCT03192176|141778522|SUPERIORITY||LSMean difference|-6.2|STANDARD_ERROR_OF_MEAN|1.94||0.0017|TWO_SIDED|95.0|-9.98|-2.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-2.34|-9.98|0.0017
71140161|NCT03192176|141778522|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.97||0.0003|TWO_SIDED|95.0|-11.09|-3.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-3.32|-11.09|0.0003
71140162|NCT03192176|141778522|SUPERIORITY||LSMean difference|-4.7|STANDARD_ERROR_OF_MEAN|1.97||0.081|TWO_SIDED|95.0|-8.55|-0.81||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.81|-8.55|0.0810
70948587|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.7||||0.7761|TWO_SIDED|95.0|0.4|6.8|||ANOVA|||Day 182||6.8|0.4|0.7761
70865867|NCT03792191|141217395|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
70865868|NCT02476201|141217424|SUPERIORITY|Using a one-sided, one sample Exact Binomial Test and a significance level of 2.5%, the study required 74 patients to reach a power of 90%. With the MPP feature activated at baseline, it was assumed that the proportion of responders at 6 months was 75%. The MPP responder rate was compared to 57%, which is the responder rate obtained from literature for patients without the MPP feature activated.|Percentage|67.1||||0.0435|ONE_SIDED|97.5|55.6||||Exact binomial||||||55.6|0.0435
70865869|NCT00398918|141217434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2|STANDARD_ERROR_OF_MEAN|3.4|<|0.05||95.0|||||Mixed Models Analysis|Results presented are for post-hoc comparisons of least squares means with Tukey-Kramer adjucted p values.|The estimated value is for the difference between the means obtained for the second hour of the self-administration sessions for the placebo and zonisamide conditions.|The analysis involved a within subjects comparison. The null hypothesis was that there would be no difference in the amount of ethanol consumed in either the first or second hour of self-administration sessions. Results presented here are for the second hour of the self-administration sessions.||||<0.05
70865870|NCT00398918|141217435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|5.7||0.61||95.0||||P value shown is for a post-hoc comparison of least squares means generated by the mixed model used.|Mixed Models Analysis||Analysis for difference between DSMT scores at 40 minutes post alcohol ingestion for zonisamide and placebo involved post-hoc comparisons of least squares means.|Null hypothesis: No difference in DSMT scores for zonisamide and placebo treatments 40 minutes after ingestion of ethanol.||||0.61
70865871|NCT00491764|141217448|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.9||||0.005||95.0|8.9|36.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||36.8|8.9|0.005
70865872|NCT00491764|141217448|SUPERIORITY_OR_OTHER||Mean Difference (Net)|54.1|||<|0.001||95.0|38.0|70.1|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||70.1|38.0|<0.001
70865873|NCT00491764|141217448|SUPERIORITY_OR_OTHER||Mean Difference (Net)|45.5|||<|0.001||95.0|28.5|62.4|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||62.4|28.5|<0.001
70865874|NCT00491764|141217448|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.0||||0.012||95.0|6.7|33.3|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||33.3|6.7|0.012
70865875|NCT00491764|141217448|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.1|||<|0.001||95.0|21.1|53.2|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||53.2|21.1|<0.001
70865876|NCT00491764|141217449|SUPERIORITY_OR_OTHER||Mean Difference (Net)|25.7||||0.002||95.0|11.2|40.2|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||40.2|11.2|0.002
70865877|NCT00491764|141217449|SUPERIORITY_OR_OTHER||Mean Difference (Net)|64.9|||<|0.001||95.0|49.5|80.2|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||80.2|49.5|<0.001
71140163|NCT03192176|141778522|SUPERIORITY||LSMean difference|-6.1|STANDARD_ERROR_OF_MEAN|1.94||0.002|TWO_SIDED|95.0|-9.88|-2.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-2.23|-9.88|0.0020
70865878|NCT00491764|141217449|SUPERIORITY_OR_OTHER||Mean Difference (Net)|48.5|||<|0.001||95.0|31.4|65.5|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||65.5|31.4|<0.001
70865879|NCT00491764|141217449|SUPERIORITY_OR_OTHER||Mean Difference (Net)|31.4|||<|0.001||95.0|16.0|46.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||46.8|16.0|<0.001
70865880|NCT00491764|141217449|SUPERIORITY_OR_OTHER||Mean Difference (Net)|54.3|||<|0.001||95.0|37.8|70.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||70.8|37.8|<0.001
70865881|NCT00491764|141217450|SUPERIORITY_OR_OTHER||Mean Difference (Net)|31.4|||<|0.001||95.0|16.0|46.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||46.8|16.0|<0.001
70865882|NCT00491764|141217450|SUPERIORITY_OR_OTHER||Mean Difference (Net)|64.9|||<|0.001||95.0|49.5|80.2|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||80.2|49.5|<0.001
70865883|NCT00491764|141217450|SUPERIORITY_OR_OTHER||Mean Difference (Net)|66.7|||<|0.001||95.0|50.6|82.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||82.8|50.6|<0.001
70865884|NCT00491764|141217450|SUPERIORITY_OR_OTHER||Mean Difference (Net)|31.4|||<|0.001||95.0|16.0|46.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||46.8|16.0|<0.001
70865885|NCT00491764|141217450|SUPERIORITY_OR_OTHER||Mean Difference (Net)|57.1|||<|0.001||95.0|40.7|73.5|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||73.5|40.7|<0.001
70865886|NCT01479478|141217451|SUPERIORITY|||||||0.87|||||||Cochran-Mantel-Haenszel|||||||0.87
70865887|NCT01188421|141217479|SUPERIORITY||F-value for main effect of Group|1.31||||0.275|TWO_SIDED|||||Main effect of Group (e.g., Buprenorphine, Tramadol, Clonidine) on COWS Total Score Ratings|ANOVA|||A power analysis determined 40 participants in each group would detect a moderate effect size, assuming an alpha of 0.05 and 80% power. Due to the expiration of buprenorphine tablets, recruitment was terminated after enrolling 103 participants. This study utilized an Intent-to-Treat (ITT) analysis. The ITT analysis includes all volunteers who signed informed consent, were randomized into the study's treatment conditions, and took at least 1 dose of study medication.||||.275
70865888|NCT01188421|141217479|SUPERIORITY||F-value for main effect of Phase|3.57||||0.03|TWO_SIDED|||||Main effect for Phase (e.g., Stabilization, Taper, Post-Taper) on COWS total score.|ANOVA|||||||0.03
71140164|NCT03192176|141778522|SUPERIORITY||LSMean difference|-5.2|STANDARD_ERROR_OF_MEAN|1.93||0.0076|TWO_SIDED|95.0|-8.98|-1.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-1.39|-8.98|0.0076
71140165|NCT03192176|141778522|SUPERIORITY||LSMean difference|-4.4|STANDARD_ERROR_OF_MEAN|1.85||0.0182|TWO_SIDED|95.0|-8.01|-0.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.75|-8.01|0.0182
71140166|NCT03192176|141778522|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.84||0.0019|TWO_SIDED|95.0|-9.42|-2.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-2.16|-9.42|0.0019
70865889|NCT01188421|141217479|SUPERIORITY||F-value for the main effect of Group x P|2.03||||0.092|TWO_SIDED|||||Main effect for Group x Phase interaction on COWS Total Score|ANOVA|||||||0.092
70865890|NCT03725852|141217481|SUPERIORITY||Least square (LS) mean difference|42.33|STANDARD_ERROR_OF_MEAN|61.483||0.495|TWO_SIDED|95.0|-81.84|166.49||P-value was based on an analysis of covariance (ANCOVA) model at each time point including treatment, sex, stratum (nintedanib, pirfenidone or neither), age, height, and baseline value as covariates.|ANCOVA|||Change at Week 26||166.49|-81.84|0.495
71140167|NCT03192176|141778522|SUPERIORITY||LSMean difference|-6.4|STANDARD_ERROR_OF_MEAN|1.86||0.0007|TWO_SIDED|95.0|-10.02|-2.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-2.71|-10.02|0.0007
71140168|NCT03192176|141778522|SUPERIORITY||LSMean difference|-7.1|STANDARD_ERROR_OF_MEAN|1.88||0.0002|TWO_SIDED|95.0|-10.76|-3.35||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-3.35|-10.76|0.0002
71140169|NCT03192176|141778522|SUPERIORITY||LSMean difference|-4.2|STANDARD_ERROR_OF_MEAN|1.88||0.0263|TWO_SIDED|95.0|-7.89|-0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.50|-7.89|0.0263
71140170|NCT03192176|141778522|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.86||0.0015|TWO_SIDED|95.0|-9.61|-2.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-2.29|-9.61|0.0015
71140171|NCT03192176|141778522|SUPERIORITY||LSMean difference|-4.7|STANDARD_ERROR_OF_MEAN|1.84||0.0113|TWO_SIDED|95.0|-8.32|-1.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.07|-8.32|0.0113
71140172|NCT03192176|141778522|SUPERIORITY||LSMean difference|-5.3|STANDARD_ERROR_OF_MEAN|1.91||0.0059|TWO_SIDED|95.0|-9.04|-1.54||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-1.54|-9.04|0.0059
71140173|NCT03192176|141778522|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.91||0.0018|TWO_SIDED|95.0|-9.76|-2.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-2.25|-9.76|0.0018
71140174|NCT03192176|141778522|SUPERIORITY||LSMean difference|-6.8|STANDARD_ERROR_OF_MEAN|1.93||0.0004|TWO_SIDED|95.0|-10.62|-3.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-3.05|-10.62|0.0004
71140175|NCT03192176|141778522|SUPERIORITY||LSMean difference|-7.6|STANDARD_ERROR_OF_MEAN|1.95||0.0001|TWO_SIDED|95.0|-11.39|-3.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-3.73|-11.39|0.0001
71140176|NCT03192176|141778522|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|1.94||0.0044|TWO_SIDED|95.0|-9.4|-1.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 10||-1.75|-9.40|0.0044
71140177|NCT03192176|141778522|SUPERIORITY||LSMean difference|-6.6|STANDARD_ERROR_OF_MEAN|1.92||0.0006|TWO_SIDED|95.0|-10.4|-2.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-2.84|-10.40|0.0006
71140178|NCT03192176|141778522|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.91||0.0025|TWO_SIDED|95.0|-9.57|-2.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-2.07|-9.57|0.0025
71140179|NCT03192176|141778522|SUPERIORITY||LSMean difference|-5.2|STANDARD_ERROR_OF_MEAN|1.86||0.0059|TWO_SIDED|95.0|-8.81|-1.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.49|-8.81|0.0059
70865891|NCT03725852|141217482|SUPERIORITY||Difference in Percentage|1.7|||||TWO_SIDED|95.0|-17.3|24.5|||||95% CI for difference calculated using the method of Miettinen and Nurminen.|TEAEs||24.5|-17.3|
71140180|NCT03192176|141778522|SUPERIORITY||LSMean difference|-6.4|STANDARD_ERROR_OF_MEAN|1.86||0.0007|TWO_SIDED|95.0|-10.06|-2.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-2.74|-10.06|0.0007
71140181|NCT03192176|141778522|SUPERIORITY||LSMean difference|-7.5|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|-11.18|-3.79||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-3.79|-11.18|<0.0001
71140182|NCT03192176|141778522|SUPERIORITY||LSMean difference|-7.5|STANDARD_ERROR_OF_MEAN|1.9||0.0001|TWO_SIDED|95.0|-11.18|-3.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-3.72|-11.18|0.0001
71140183|NCT03192176|141778522|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.89||0.0022|TWO_SIDED|95.0|-9.56|-2.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-2.11|-9.56|0.0022
71140184|NCT03192176|141778522|SUPERIORITY||LSMean difference|-6.9|STANDARD_ERROR_OF_MEAN|1.87||0.0003|TWO_SIDED|95.0|-10.56|-3.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-3.19|-10.56|0.0003
71140185|NCT03192176|141778522|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.86||0.002|TWO_SIDED|95.0|-9.44|-2.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-2.13|-9.44|0.0020
71140186|NCT03192176|141778522|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|1.82||0.0023|TWO_SIDED|95.0|-9.18|-2.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-2.01|-9.18|0.0023
71140187|NCT03192176|141778522|SUPERIORITY||LSMean difference|-6.5|STANDARD_ERROR_OF_MEAN|1.82||0.0004|TWO_SIDED|95.0|-10.06|-2.89||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-2.89|-10.06|0.0004
71140188|NCT03192176|141778522|SUPERIORITY||LSMean difference|-7.4|STANDARD_ERROR_OF_MEAN|1.84|<|0.0001|TWO_SIDED|95.0|-11.05|-3.81||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-3.81|-11.05|<0.0001
71140189|NCT03192176|141778522|SUPERIORITY||LSMean difference|-8.1|STANDARD_ERROR_OF_MEAN|1.86|<|0.0001|TWO_SIDED|95.0|-11.8|-4.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-4.49|-11.80|<0.0001
71140190|NCT03192176|141778522|SUPERIORITY||LSMean difference|-6.1|STANDARD_ERROR_OF_MEAN|1.85||0.0011|TWO_SIDED|95.0|-9.77|-2.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-2.47|-9.77|0.0011
71140191|NCT03192176|141778522|SUPERIORITY||LSMean difference|-6.9|STANDARD_ERROR_OF_MEAN|1.83||0.0002|TWO_SIDED|95.0|-10.54|-3.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-3.32|-10.54|0.0002
71140192|NCT03192176|141778522|SUPERIORITY||LSMean difference|-6.1|STANDARD_ERROR_OF_MEAN|1.82||0.0008|TWO_SIDED|95.0|-9.71|-2.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-2.56|-9.71|0.0008
71140193|NCT03192176|141778522|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|2.15||0.0054|TWO_SIDED|95.0|-10.26|-1.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-1.80|-10.26|0.0054
70865892|NCT03725852|141217482|SUPERIORITY||Difference in Percentage|15.7|||||TWO_SIDED|95.0|-3.0|30.7|||||95% CI for difference calculated using the method of Miettinen and Nurminen.|Serious TEAEs||30.7|-3.0|
70865893|NCT03725852|141217482|SUPERIORITY||Difference in Percentage|31.4|||||TWO_SIDED|95.0|8.2|49.4|||||95% CI for difference calculated using the method of Miettinen and Nurminen.|TEAEs related to study drug||49.4|8.2|
70865894|NCT03725852|141217482|SUPERIORITY||Difference in Percentage|22.2|||||TWO_SIDED|95.0|6.7|36.4|||||95% CI for difference calculated using the method of Miettinen and Nurminen.|TEAEs leading to study drug discontinuation||36.4|6.7|
70865895|NCT03725852|141217483|SUPERIORITY|||||||0.397|||||||Log Rank|||All-cause deaths||||0.397
70865896|NCT03725852|141217483|SUPERIORITY|||||||0.397|||||||Log Rank|||Respiratory-related deaths||||0.397
70865897|NCT03725852|141217483|SUPERIORITY|||||||0.131|||||||Log Rank|||All-cause hospitalizations||||0.131
70865898|NCT03725852|141217483|SUPERIORITY|||||||0.762|||||||Log Rank|||Respiratory-related hospitalizations||||0.762
70948588|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.7833|TWO_SIDED|95.0|0.2|2.1|||ANOVA|||Day 365||2.1|0.2|0.7833
70948589|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.8||||0.9915|TWO_SIDED|95.0|0.2|2.9|||ANOVA|||Day 365||2.9|0.2|0.9915
70948590|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.9||||0.998|TWO_SIDED|95.0|0.3|3.0|||ANOVA|||Day 365||3.0|0.3|0.9980
70948591|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.4||||0.909|TWO_SIDED|95.0|0.4|4.9|||ANOVA|||Day 365||4.9|0.4|0.9090
70948592|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.3||||0.9651|TWO_SIDED|95.0|0.4|4.7|||ANOVA|||Day 365||4.7|0.4|0.9651
70948593|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.4||||0.9112|TWO_SIDED|95.0|0.4|4.7|||ANOVA|||Day 365||4.7|0.4|0.9112
70948594|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.4||||0.257|TWO_SIDED|95.0|0.7|7.8|||ANOVA|||Day 365||7.8|0.7|0.2570
70948595|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.1||||0.9999|TWO_SIDED|95.0|0.3|3.8|||ANOVA|||Day 365||3.8|0.3|0.9999
70948596|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.8||||0.6953|TWO_SIDED|95.0|0.5|6.2|||ANOVA|||Day 365||6.2|0.5|0.6953
70948597|NCT03635086|141398234|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.7||||0.7523|TWO_SIDED|95.0|0.5|5.4|||ANOVA|||Day 365||5.4|0.5|0.7523
71140194|NCT03192176|141778522|SUPERIORITY||LSMean difference|-3.4|STANDARD_ERROR_OF_MEAN|2.15||0.1145|TWO_SIDED|95.0|-7.63|0.83||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMMRM|||Week 13||0.83|-7.63|0.1145
71140195|NCT03192176|141778522|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|2.21||0.2106|TWO_SIDED|95.0|-7.13|1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||1.58|-7.13|0.2106
70948598|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups|Geometric Mean Ratio Estimate|0.5||||0.5263|TWO_SIDED|95.0|0.1|1.7|||ANOVA|||Day 0||1.7|0.1|0.5263
70948599|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.3|3.5|||ANOVA|||Day 0||3.5|0.3|1.0000
70948600|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.3|3.4|||ANOVA|||Day 0||3.4|0.3|1.0000
70948601|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.3|3.4|||ANOVA|||Day 0||3.4|0.3|1.0000
70948602|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|2.0||||0.55|TWO_SIDED|95.0|0.6|7.0|||ANOVA|||Day 0||7.0|0.6|0.5500
70948603|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|2.0||||0.5263|TWO_SIDED|95.0|0.6|6.7|||ANOVA|||Day 0||6.7|0.6|0.5263
70948604|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.0||||0.5263|TWO_SIDED|95.0|0.6|6.7|||ANOVA|||Day 0||6.7|0.6|0.5263
70948605|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.3|3.5|||ANOVA|||Day 0||3.5|0.3|1.0000
70948606|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.3|3.5|||ANOVA|||Day 0||3.5|0.3|1.0000
70948607|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.3|3.4|||ANOVA|||Day 0||3.4|0.3|1.0000
71140196|NCT03192176|141778522|SUPERIORITY||LSMean difference|-4.0|STANDARD_ERROR_OF_MEAN|2.21||0.0685|TWO_SIDED|95.0|-8.39|0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|LSMean difference|||Week 13||0.31|-8.39|0.0685
71140197|NCT03192176|141778522|SUPERIORITY||LSMean difference|-6.7|STANDARD_ERROR_OF_MEAN|2.22||0.0029|TWO_SIDED|95.0|-11.02|-2.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-2.29|-11.02|0.0029
71140198|NCT03192176|141778522|SUPERIORITY||LSMean difference|-5.0|STANDARD_ERROR_OF_MEAN|2.22||0.0239|TWO_SIDED|95.0|-9.42|-0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.67|-9.42|0.0239
71140199|NCT03192176|141778522|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|2.15||0.2224|TWO_SIDED|95.0|-6.86|1.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||1.60|-6.86|0.2224
70948608|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.5||||0.7708|TWO_SIDED|95.0|0.1|2.4|||ANOVA|||Day 28||2.4|0.1|0.7708
70948609|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.2||||0.9966|TWO_SIDED|95.0|0.3|5.4|||ANOVA|||Day 28||5.4|0.3|0.9966
70948610|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.7||||0.9503|TWO_SIDED|95.0|0.2|3.0|||ANOVA|||Day 28||3.0|0.2|0.9503
71140200|NCT03192176|141778522|SUPERIORITY||LSMean differencce|-4.8|STANDARD_ERROR_OF_MEAN|2.22||0.0308|TWO_SIDED|95.0|-9.17|-0.45||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.45|-9.17|0.0308
71140201|NCT03192176|141778522|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|2.21||0.4194|TWO_SIDED|95.0|-6.13|2.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||2.56|-6.13|0.4194
71140202|NCT03192176|141778522|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|2.29||0.3759|TWO_SIDED|95.0|-6.55|2.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||2.48|-6.55|0.3759
71140203|NCT03192176|141778522|SUPERIORITY||LSMean differencce|-2.8|STANDARD_ERROR_OF_MEAN|2.29||0.2285|TWO_SIDED|95.0|-7.26|1.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.74|-7.26|0.2285
70948611|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.7||||0.9791|TWO_SIDED|95.0|0.2|3.2|||ANOVA|||Day 28||3.2|0.2|0.9791
71140204|NCT03192176|141778522|SUPERIORITY||LSMean difference|-6.2|STANDARD_ERROR_OF_MEAN|2.29||0.0072|TWO_SIDED|95.0|-10.71|-1.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-1.70|-10.71|0.0072
71140205|NCT03192176|141778522|SUPERIORITY||LSMean difference|-4.9|STANDARD_ERROR_OF_MEAN|2.31||0.0338|TWO_SIDED|95.0|-9.46|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.38|-9.46|0.0338
71140206|NCT03192176|141778522|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|2.21||0.3026|TWO_SIDED|95.0|-6.64|2.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||2.07|-6.64|0.3026
71140207|NCT03192176|141778522|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|2.16||0.312|TWO_SIDED|95.0|-6.45|2.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||2.07|-6.45|0.3120
71140208|NCT03192176|141778522|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|2.15||0.6816|TWO_SIDED|95.0|-5.11|3.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||3.34|-5.11|0.6816
71140209|NCT03192176|141778522|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|2.26||0.8599|TWO_SIDED|95.0|-4.85|4.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||4.05|-4.85|0.8599
71140210|NCT03192176|141778522|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|2.23||0.9093|TWO_SIDED|95.0|-4.64|4.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||4.13|-4.64|0.9093
70948612|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.2||||0.5739|TWO_SIDED|95.0|0.5|9.8|||ANOVA|||Day 28||9.8|0.5|0.5739
71140211|NCT03192176|141778522|SUPERIORITY||LSMean difference|-4.0|STANDARD_ERROR_OF_MEAN|2.26||0.0788|TWO_SIDED|95.0|-8.43|0.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.46|-8.43|0.0788
70948613|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.3||||0.9918|TWO_SIDED|95.0|0.3|5.4|||ANOVA|||Day 28||5.4|0.3|0.9918
70948614|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.4||||0.9748|TWO_SIDED|95.0|0.3|5.9|||ANOVA|||Day 28||5.9|0.3|0.9748
70948615|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.827|TWO_SIDED|95.0|0.1|2.6|||ANOVA|||Day 28||2.6|0.1|0.8270
70948616|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.893|TWO_SIDED|95.0|0.1|2.8|||ANOVA|||Day 28||2.8|0.1|0.8930
70948617|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.1||||0.9999|TWO_SIDED|95.0|0.3|4.7|||ANOVA|||Day 28||4.7|0.3|0.9999
71140212|NCT03192176|141778522|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|2.26||0.1278|TWO_SIDED|95.0|-7.92|1.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.00|-7.92|0.1278
71140213|NCT03192176|141778522|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|2.15||0.9848|TWO_SIDED|95.0|-4.19|4.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||4.27|-4.19|0.9848
71140214|NCT03192176|141778523|SUPERIORITY||LSMean difference|14.6|STANDARD_ERROR_OF_MEAN|7.05||0.0388|TWO_SIDED|95.0|0.76|28.49||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|MMRM: Mixed Model Repeated Measures||Week 1||28.49|0.76|0.0388
71140215|NCT03192176|141778523|SUPERIORITY||LSMean difference|23.1|STANDARD_ERROR_OF_MEAN|7.08||0.0012|TWO_SIDED|95.0|9.17|37.02||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||37.02|9.17|0.0012
71140216|NCT03192176|141778523|SUPERIORITY||LSMean difference|37.3|STANDARD_ERROR_OF_MEAN|7.07|<|0.0001|TWO_SIDED|95.0|23.41|51.22||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||51.22|23.41|<0.0001
71140217|NCT03192176|141778523|SUPERIORITY||LSMean difference|41.0|STANDARD_ERROR_OF_MEAN|7.16|<|0.0001|TWO_SIDED|95.0|26.88|55.05||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||55.05|26.88|<0.0001
71140218|NCT03192176|141778523|SUPERIORITY||LSMean difference|8.2|STANDARD_ERROR_OF_MEAN|7.19||0.2569|TWO_SIDED|95.0|-5.98|22.32||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||22.32|-5.98|0.2569
71140219|NCT03192176|141778523|SUPERIORITY||LSMean difference|25.6|STANDARD_ERROR_OF_MEAN|7.07||0.0003|TWO_SIDED|95.0|11.65|39.47||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||39.47|11.65|0.0003
71140220|NCT03192176|141778523|SUPERIORITY||LSMean difference|30.2|STANDARD_ERROR_OF_MEAN|7.03|<|0.0001|TWO_SIDED|95.0|16.39|44.06||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||44.06|16.39|<0.0001
71140221|NCT03192176|141778523|SUPERIORITY||LSMean difference|15.9|STANDARD_ERROR_OF_MEAN|7.02||0.024|TWO_SIDED|95.0|2.11|29.71||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||29.71|2.11|0.0240
71140222|NCT03192176|141778523|SUPERIORITY||LSMean difference|24.5|STANDARD_ERROR_OF_MEAN|7.05||0.0006|TWO_SIDED|95.0|10.62|38.37||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||38.37|10.62|0.0006
71140223|NCT03192176|141778523|SUPERIORITY||LSMean differencce|33.7|STANDARD_ERROR_OF_MEAN|7.03|<|0.0001|TWO_SIDED|95.0|19.87|47.52||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||47.52|19.87|<0.0001
71140224|NCT03192176|141778523|SUPERIORITY||LSMean difference|38.0|STANDARD_ERROR_OF_MEAN|7.15|<|0.0001|TWO_SIDED|95.0|23.93|52.04||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||52.04|23.93|<0.0001
71140225|NCT03192176|141778523|SUPERIORITY||LSMean difference|14.5|STANDARD_ERROR_OF_MEAN|7.16||0.0441|TWO_SIDED|95.0|0.38|28.53||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||28.53|0.38|0.0441
71140226|NCT03192176|141778523|SUPERIORITY||LSMean difference|19.4|STANDARD_ERROR_OF_MEAN|7.04||0.0061|TWO_SIDED|95.0|5.58|33.28||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||33.28|5.58|0.0061
71140227|NCT03192176|141778523|SUPERIORITY||LSMean difference|25.7|STANDARD_ERROR_OF_MEAN|7.01||0.0003|TWO_SIDED|95.0|11.96|39.53||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||39.53|11.96|0.0003
71140228|NCT03192176|141778523|SUPERIORITY||LSMean difference|20.2|STANDARD_ERROR_OF_MEAN|7.55||0.0078|TWO_SIDED|95.0|5.36|35.07||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||35.07|5.36|0.0078
70948618|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.9105|TWO_SIDED|95.0|0.1|3.2|||ANOVA|||Day 56||3.2|0.1|0.9105
70948619|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.2|5.5|||ANOVA|||Day 56||5.5|0.2|1.0000
71140229|NCT03192176|141778523|SUPERIORITY||LSMean difference|28.3|STANDARD_ERROR_OF_MEAN|7.59||0.0002|TWO_SIDED|95.0|13.36|43.22||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||43.22|13.36|0.0002
70865899|NCT03725852|141217484|SUPERIORITY||Weighted LS mean difference|-9.11|STANDARD_ERROR_OF_MEAN|15.713||0.565|TWO_SIDED|95.0|-40.87|22.64||P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline 6MWT distance as covariates.|ANCOVA|||Change at Week 26||22.64|-40.87|0.565
71140230|NCT03192176|141778523|SUPERIORITY||LSMean difference|36.9|STANDARD_ERROR_OF_MEAN|7.55|<|0.0001|TWO_SIDED|95.0|22.07|51.77||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||51.77|22.07|<0.0001
71140231|NCT03192176|141778523|SUPERIORITY||LSMean difference|40.5|STANDARD_ERROR_OF_MEAN|7.69|<|0.0001|TWO_SIDED|95.0|25.41|55.67||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRm|||Week 3||55.67|25.41|<0.0001
71140232|NCT03192176|141778523|SUPERIORITY||LSMean difference|19.7|STANDARD_ERROR_OF_MEAN|7.7||0.0108|TWO_SIDED|95.0|4.59|34.88||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||34.88|4.59|0.0108
71140233|NCT03192176|141778523|SUPERIORITY||LSMean difference|25.0|STANDARD_ERROR_OF_MEAN|7.56||0.0011|TWO_SIDED|95.0|10.09|39.84||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||39.84|10.09|0.0011
71140234|NCT03192176|141778523|SUPERIORITY||LSMean difference|30.9|STANDARD_ERROR_OF_MEAN|7.53|<|0.0001|TWO_SIDED|95.0|16.03|45.67||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||45.67|16.03|<0.0001
71140235|NCT03192176|141778523|SUPERIORITY||LSMean difference|20.5|STANDARD_ERROR_OF_MEAN|7.47||0.0063|TWO_SIDED|95.0|5.84|35.23||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||35.23|5.84|0.0063
71140236|NCT03192176|141778523|SUPERIORITY||LSMean difference|28.7|STANDARD_ERROR_OF_MEAN|7.49||0.0002|TWO_SIDED|95.0|13.98|43.46||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||43.46|13.98|0.0002
71140237|NCT03192176|141778523|SUPERIORITY||LSMean difference|33.3|STANDARD_ERROR_OF_MEAN|7.46|<|0.0001|TWO_SIDED|95.0|18.66|48.0||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||48.00|18.66|<0.0001
71140238|NCT03192176|141778523|SUPERIORITY||LSMean difference|41.5|STANDARD_ERROR_OF_MEAN|7.6|<|0.0001|TWO_SIDED|95.0|26.52|56.41||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||56.41|26.52|<0.0001
71140239|NCT03192176|141778523|SUPERIORITY||LSMean difference|19.7|STANDARD_ERROR_OF_MEAN|7.59||0.0098|TWO_SIDED|95.0|4.78|34.66||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||34.66|4.78|0.0098
71140240|NCT03192176|141778523|SUPERIORITY||LSMean difference|29.9|STANDARD_ERROR_OF_MEAN|7.46|<|0.0001|TWO_SIDED|95.0|15.26|44.61||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||44.61|15.26|<0.0001
70865900|NCT03725852|141217485|SUPERIORITY||Weighted LS mean difference.|-1.58|STANDARD_ERROR_OF_MEAN|3.71||0.673|TWO_SIDED|95.0|-9.06|5.91||P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline SGRQ value as covariates.|ANCOVA|||Change at Week 26||5.91|-9.06|0.673
70865901|NCT03725852|141217486|SUPERIORITY||Weighted LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|4.591||0.875|TWO_SIDED|95.0|-9.98|8.53||P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline SGRQ value as covariates.|ANCOVA|||Change at Week 26: Symptoms score||8.53|-9.98|0.875
70948620|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.3||||0.3047|TWO_SIDED|95.0|0.1|1.7|||ANOVA|||Day 56||1.7|0.1|0.3047
70948621|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|5.5||||0.0423|TWO_SIDED|95.0|1.0|29.2|||ANOVA|||Day 56||29.2|1.0|0.0423
70948622|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.6||||0.9213|TWO_SIDED|95.0|0.3|9.1|||ANOVA|||Day 56||9.1|0.3|0.9213
71140241|NCT03192176|141778523|SUPERIORITY||LSMean difference|33.1|STANDARD_ERROR_OF_MEAN|7.43|<|0.0001|TWO_SIDED|95.0|18.5|47.73||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||47.73|18.50|<0.0001
71140242|NCT03192176|141778523|SUPERIORITY||LSMean difference|15.4|STANDARD_ERROR_OF_MEAN|7.1||0.0303|TWO_SIDED|95.0|1.48|29.4||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||29.40|1.48|0.0303
71140243|NCT03192176|141778523|SUPERIORITY||LSMean difference|24.8|STANDARD_ERROR_OF_MEAN|7.11||0.0006|TWO_SIDED|95.0|10.77|38.74||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||38.74|10.77|0.0006
71140244|NCT03192176|141778523|SUPERIORITY||LSMean difference|30.8|STANDARD_ERROR_OF_MEAN|7.11|<|0.0001|TWO_SIDED|95.0|16.77|44.75||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||44.75|16.77|<0.0001
71140245|NCT03192176|141778523|SUPERIORITY||LSMean difference|38.8|STANDARD_ERROR_OF_MEAN|7.23|<|0.0001|TWO_SIDED|95.0|24.55|53.0||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||53.00|24.55|<0.0001
71140246|NCT03192176|141778523|SUPERIORITY||LSMean difference|19.1|STANDARD_ERROR_OF_MEAN|7.2||0.0086|TWO_SIDED|95.0|4.88|33.23||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||33.23|4.88|0.0086
71140247|NCT03192176|141778523|SUPERIORITY||LSMean difference|22.3|STANDARD_ERROR_OF_MEAN|7.09||0.0018|TWO_SIDED|95.0|8.33|36.24||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||36.24|8.33|0.0018
71140248|NCT03192176|141778523|SUPERIORITY||LSMean difference|25.1|STANDARD_ERROR_OF_MEAN|7.07||0.0004|TWO_SIDED|95.0|11.24|39.05||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||39.05|11.24|0.0004
71140249|NCT03192176|141778523|SUPERIORITY||LSMean difference|14.6|STANDARD_ERROR_OF_MEAN|6.62||0.0282|TWO_SIDED|95.0|1.56|27.6||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||27.60|1.56|0.0282
71140250|NCT03192176|141778523|SUPERIORITY||LSMean difference|19.9|STANDARD_ERROR_OF_MEAN|6.63||0.0029|TWO_SIDED|95.0|6.85|32.92||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||32.92|6.85|0.0029
71140251|NCT03192176|141778523|SUPERIORITY||LSMean difference|29.7|STANDARD_ERROR_OF_MEAN|6.65|<|0.0001|TWO_SIDED|95.0|16.58|42.73||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||42.73|16.58|<0.0001
71140252|NCT03192176|141778523|SUPERIORITY||LSMean difference|35.7|STANDARD_ERROR_OF_MEAN|6.75|<|0.0001|TWO_SIDED|95.0|22.42|48.99||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||48.99|22.42|<0.0001
71140253|NCT03192176|141778523|SUPERIORITY||LSMean difference|14.6|STANDARD_ERROR_OF_MEAN|6.74||0.0304|TWO_SIDED|95.0|1.4|27.9||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||27.90|1.40|0.0304
71140254|NCT03192176|141778523|SUPERIORITY||LSMean difference|20.4|STANDARD_ERROR_OF_MEAN|6.64||0.0022|TWO_SIDED|95.0|7.38|33.5||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||33.50|7.38|0.0022
71140255|NCT03192176|141778523|SUPERIORITY||LSMean difference|26.5|STANDARD_ERROR_OF_MEAN|6.59|<|0.0001|TWO_SIDED|95.0|13.56|39.5||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||39.50|13.56|<0.0001
71140256|NCT03192176|141778523|SUPERIORITY||LSMean difference|14.4|STANDARD_ERROR_OF_MEAN|6.87||0.0362|TWO_SIDED|95.0|0.93|27.95||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||27.95|0.93|0.0362
71140257|NCT03192176|141778523|SUPERIORITY||LSMean difference|22.9|STANDARD_ERROR_OF_MEAN|6.88||0.0009|TWO_SIDED|95.0|9.41|36.47||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||36.47|9.41|0.0009
71140258|NCT03192176|141778523|SUPERIORITY||LSMean difference|28.9|STANDARD_ERROR_OF_MEAN|6.91|<|0.0001|TWO_SIDED|95.0|15.27|42.46||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||42.46|15.27|<0.0001
70865902|NCT03725852|141217486|SUPERIORITY||Weighted LS mean difference|-4.14|STANDARD_ERROR_OF_MEAN|5.038||0.416|TWO_SIDED|95.0|-14.29|6.02||P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline SGRQ value as covariates.|ANCOVA|||Change at Week 26: Activity score||6.02|-14.29|0.416
70865903|NCT03725852|141217486|SUPERIORITY||Weighted LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|4.029||0.961|TWO_SIDED|95.0|-8.32|7.92||P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline SGRQ value as covariates.|ANCOVA|||Change at Week 26: Impacts score||7.92|-8.32|0.961
70865904|NCT03725852|141217487|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
70865905|NCT00116428|141217491|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Log Rank|||The study null hypothesis is that the chronic success rates for the THERMOCOOL and AAD groups are equal.||||<0.001
70865906|NCT02572609|141217528|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence in the Cmax will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|T/R Ratio|113.56|STANDARD_DEVIATION|16.24||0.0082|TWO_SIDED|90.0|106.48|121.1|||Anderson-Hauck procedure||Standard Deviation is actually the Coefficient of variation intra subject (CVintra).|||121.10|106.48|0.0082
70865907|NCT02572609|141217529|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence in the AUC0-t will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|T/R Ratio|119.61|STANDARD_DEVIATION|10.65||0.0438|TWO_SIDED|90.0|114.65|124.79|||Anderson-Hauck procedure||Standard Deviation is actually the Coefficient of variation intra subject (CVintra).|||124.79|114.65|0.0438
70865908|NCT01848704|141217530|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.03|TWO_SIDED|95.0|0.07|1.35|||Mixed Models Analysis|||||1.35|0.07|0.03
70865909|NCT01848704|141217531|SUPERIORITY||Mean Difference (Final Values)|-0.59||||0.03|TWO_SIDED|95.0|-1.13|-0.05|||Mixed Models Analysis|||||-0.05|-1.13|0.03
70865910|NCT01848704|141217532|SUPERIORITY||Mean Difference (Final Values)|-0.38||||0.18|TWO_SIDED|95.0|-0.95|0.19|||Mixed Models Analysis|||||0.19|-0.95|0.18
71140259|NCT03192176|141778523|SUPERIORITY||LSMean difference|36.8|STANDARD_ERROR_OF_MEAN|7.01|<|0.0001|TWO_SIDED|95.0|22.99|50.57||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||50.57|22.99|<0.0001
71140260|NCT03192176|141778523|SUPERIORITY||LSMean difference|15.6|STANDARD_ERROR_OF_MEAN|6.99||0.0265|TWO_SIDED|95.0|1.83|29.34||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||29.34|1.83|0.0265
70865911|NCT01848704|141217533|SUPERIORITY||Mean Difference (Final Values)|0.77||||0.029|TWO_SIDED|95.0|0.08|1.47|||Mixed Models Analysis|||||1.47|0.08|0.029
70865912|NCT01848704|141217534|SUPERIORITY||Mean Difference (Final Values)|0.64||||0.061|TWO_SIDED|95.0|-0.03|1.31|||Mixed Models Analysis|||||1.31|-0.03|0.061
70865913|NCT02155881|141217552|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.9716|TWO_SIDED|95.0|-0.98|1.01|||ANCOVA|||An analysis of covariance (ANCOVA) model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||1.01|-0.98|0.9716
70865914|NCT02155881|141217553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.8713|TWO_SIDED|95.0|-0.87|1.02|||ANCOVA|||An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||1.02|-0.87|0.8713
70865915|NCT02155881|141217554|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.7789|TWO_SIDED|95.0|-0.61|0.81|||ANCOVA|||An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.81|-0.61|0.7789
70865916|NCT02155881|141217555|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15||||0.663|TWO_SIDED|95.0|-0.55|0.86|||ANCOVA|||An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.86|-0.55|0.6630
70865917|NCT02155881|141217556|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.5593|TWO_SIDED|95.0|-0.35|0.19|||ANCOVA|||Nasal congestion: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.19|-0.35|0.5593
70865918|NCT02155881|141217556|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.7085|TWO_SIDED|95.0|-0.22|0.33|||ANCOVA|||Runny nose: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.33|-0.22|0.7085
70865919|NCT02155881|141217556|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.7309|TWO_SIDED|95.0|-0.22|0.31|||ANCOVA|||Itching: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.31|-0.22|0.7309
70865920|NCT02155881|141217556|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.9584|TWO_SIDED|95.0|-0.29|0.3|||ANCOVA|||Sneezing: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.30|-0.29|0.9584
70865921|NCT02155881|141217557|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.2266|TWO_SIDED|95.0|-0.11|0.46|||ANCOVA|||Itching/Burning Eyes: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.46|-0.11|0.2266
71140261|NCT03192176|141778523|SUPERIORITY||LSMean difference|21.2|STANDARD_ERROR_OF_MEAN|6.89||0.0023|TWO_SIDED|95.0|7.6|34.71||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||34.71|7.60|0.0023
70865922|NCT02155881|141217557|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.4888|TWO_SIDED|95.0|-0.35|0.17|||ANCOVA|||Redness: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.17|-0.35|0.4888
70865923|NCT02155881|141217557|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.8316|TWO_SIDED|95.0|-0.22|0.27|||ANCOVA|||Tearing/Watering Eyes: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.27|-0.22|0.8316
70865924|NCT02155881|141217558|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28||||0.2968|TWO_SIDED|95.0|-0.8|0.25|||ANCOVA|||An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.25|-0.80|0.2968
70865925|NCT02155881|141217559|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.3533|TWO_SIDED|95.0|-0.85|0.31|||ANCOVA|||Activities: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.31|-0.85|0.3533
70865926|NCT02155881|141217559|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26||||0.3712|TWO_SIDED|95.0|-0.84|0.32|||ANCOVA|||Sleep: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.32|-0.84|0.3712
70865927|NCT02155881|141217559|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.4098|TWO_SIDED|95.0|-0.69|0.29|||ANCOVA|||Non-nose/Eye symptoms: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.29|-0.69|0.4098
70865928|NCT02155881|141217559|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.2683|TWO_SIDED|95.0|-1.0|0.28|||ANCOVA|||Practical Problems: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.28|-1.00|0.2683
70865929|NCT02155881|141217559|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.4643|TWO_SIDED|95.0|-0.82|0.38|||ANCOVA|||Nasal Symptoms: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.38|-0.82|0.4643
70865930|NCT02155881|141217559|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.4502|TWO_SIDED|95.0|-0.74|0.33|||ANCOVA|||Eye symptoms: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.33|-0.74|0.4502
70865931|NCT02155881|141217559|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||0.177|TWO_SIDED|95.0|-0.95|0.18|||ANCOVA|||Emotional: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.18|-0.95|0.1770
71140262|NCT03192176|141778523|SUPERIORITY||LSMean difference|27.1|STANDARD_ERROR_OF_MEAN|6.85|<|0.0001|TWO_SIDED|95.0|13.64|40.59||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||40.59|13.64|<0.0001
70865932|NCT01967173|141217594|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Fluticasone 250 is equal to the inferiority of Advair 100/50 compared to Fluticasone 250||||0.003
70865933|NCT01967173|141217594|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Fluticasone 250 is equal to the inferiority of Advair 100/50 compared to Fluticasone 250||||0.9
70865934|NCT01967173|141217594|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Fluticasone 500 is equal to the inferiority of Advair 100/50 compared to Fluticasone 500||||<0.001
70865935|NCT01967173|141217594|SUPERIORITY|||||||0.42|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Advair 250/50 is equal to the inferiority of Advair 100/50 compared to Advair 250/50||||0.42
70865936|NCT01967173|141217594|SUPERIORITY|||||||0.84|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Advair 250/50 is equal to the inferiority of Advair 100/50 compared to Advair 250/50||||0.84
70865937|NCT01967173|141217594|SUPERIORITY|||||||0.015|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 250/50 compared to Fluticasone 500 is equal to the inferiority of Advair 250/50 compared to Fluticasone 500||||0.015
70865938|NCT01967173|141217594|SUPERIORITY|||||||0.085|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 250/50 compared to Fluticasone 250 is equal to the inferiority of Advair 250/50 compared to Fluticasone 250||||0.085
70865939|NCT01967173|141217594|SUPERIORITY|||||||0.62|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 250/50 compared to Fluticasone 250 is equal to the inferiority of Advair 250/50 compared to Fluticasone 250||||0.62
70865940|NCT01967173|141217594|SUPERIORITY|||||||0.48|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Fluticasone 500 compared to Fluticasone 250 is equal to the inferiority of Fluticasone 500 compared to Fluticasone 250||||0.48
70865941|NCT01967173|141217594|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Fluticasone 100 is equal to the inferiority of Advair 100/50 compared to Fluticasone 100||||0.14
70865942|NCT01967173|141217594|SUPERIORITY|||||||0.096|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Fluticasone 250 compared to Fluticasone 100 is equal to the inferiority of Fluticasone 250 compared to Fluticasone 100||||0.096
70865943|NCT03685123|141217598|SUPERIORITY|||||||0.256|||||||Mixed Models Analysis|||||||0.256
70865944|NCT03685123|141217599|SUPERIORITY|||||||0.089|||||||Mixed Models Analysis|||||||0.089
70865945|NCT03685123|141217600|SUPERIORITY|||||||0.244|||||||Mixed Models Analysis|||||||0.244
70865946|NCT03685123|141217601|SUPERIORITY|||||||0.064|||||||Mixed Models Analysis|||||||0.064
70865947|NCT03685123|141217602|SUPERIORITY|||||||0.983|||||||Mixed Models Analysis|||LDL levels||||0.983
70865948|NCT03685123|141217602|SUPERIORITY|||||||0.56|||||||Mixed Models Analysis|||HDL levels||||0.56
70865949|NCT03685123|141217602|SUPERIORITY|||||||0.71|||||||Mixed Models Analysis|||Total Cholesterol||||0.71
70865950|NCT03685123|141217602|SUPERIORITY|||||||0.313|||||||Mixed Models Analysis|||Triglycerides||||0.313
70865951|NCT03685123|141217603|SUPERIORITY|||||||0.72|||||||Mixed Models Analysis|||systolic Blood pressure||||0.72
70865952|NCT03685123|141217603|SUPERIORITY|||||||0.61|||||||Mixed Models Analysis|||Diastolic Blood pressure||||0.61
70865953|NCT03685123|141217603|SUPERIORITY|||||||0.1609|||||||Mixed Models Analysis|||Change in aortic blood pressure between the PA-REC and the WM-REC Groups.||||0.1609
70865954|NCT03685123|141217603|SUPERIORITY|||||||0.446|||||||Mixed Models Analysis|||Change in aortic diastolic blood pressure between the PA-REC and WM-REC Groups||||0.446
70865955|NCT03685123|141217604|SUPERIORITY|||||||0.965|||||||Mixed Models Analysis|||||||0.965
70865956|NCT03685123|141217605|SUPERIORITY|||||||0.857|||||||Mixed Models Analysis|||||||0.857
70865957|NCT03685123|141217606|SUPERIORITY|||||||0.825|||||||Mixed Models Analysis|||||||0.825
70865958|NCT03685123|141217607|SUPERIORITY|||||||0.061|||||||Mixed Models Analysis|||||||0.061
70865959|NCT03685123|141217609|SUPERIORITY|Change in particle size between the PA-REC and WM-REC groups||||||0.105|||||||Mixed Models Analysis|||Change in HDL particle size||||0.105
70865960|NCT03685123|141217609|SUPERIORITY|Change in particle size between the PA-REC and the WM-REC groups||||||0.849|||||||Mixed Models Analysis|||Change in LDL particles||||0.849
70865961|NCT03685123|141217611|SUPERIORITY|||||||0.278|||||||ANOVA|||Change in steps per day from week 10 to week 28||||0.278
70865962|NCT03685123|141217612|SUPERIORITY|||||||0.238|||||||Mixed Models Analysis|||Change in SF-36 General Health (GH)||||0.238
70865963|NCT03685123|141217612|SUPERIORITY|Between groups analysis between the change in PA-REC Group vs. the WM-REC Group||||||0.124|||||||Mixed Models Analysis|||Change in SF-36 Physical health (PH)||||0.124
71140263|NCT03192176|141778523|SUPERIORITY||LSMean difference|9.6|STANDARD_ERROR_OF_MEAN|6.8||0.158|TWO_SIDED|95.0|-3.75|22.99||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||22.99|-3.75|0.1580
70865964|NCT03685123|141217612|SUPERIORITY|Between groups analysis between the change in PA-REC Group vs. the WM-REC Group||||||0.769|||||||Mixed Models Analysis|||Change in SF-36 role physical||||0.769
70865965|NCT03685123|141217612|SUPERIORITY|Between groups analysis between the change in PA-REC Group vs. the WM-REC Group||||||0.352|||||||Mixed Models Analysis|||Change in SF-36 Bodily Pain||||0.352
70865966|NCT03685123|141217612|SUPERIORITY|Between groups analysis between the change in PA-REC Group vs. the WM-REC Group||||||0.898|||||||Mixed Models Analysis|||Change in SF-36 Vitality||||0.898
70865967|NCT03685123|141217612|SUPERIORITY|Between groups analysis between the change in PA-REC Group vs. the WM-REC Group||||||0.444|||||||Mixed Models Analysis|||Change in SF-36 social function||||0.444
70865968|NCT03685123|141217612|SUPERIORITY|Change between the PA-REC group and the WM-REC group||||||0.537|||||||Mixed Models Analysis|||Change in SF-36 Mental Health||||0.537
70865969|NCT03685123|141217612|SUPERIORITY|||||||0.448|||||||Mixed Models Analysis|||Change in SF-36 Role Emotional||||0.448
70865970|NCT03685123|141217612|SUPERIORITY|Change between the PA-REC group and the WM-REC group||||||0.537|||||||Mixed Models Analysis|||Change in SF-36 Mental Health (Sum)||||0.537
70865971|NCT03685123|141217612|SUPERIORITY|Change between the PA-REC group and the WM-REC group||||||0.482|||||||Mixed Models Analysis|||Change in SF-36 Physical Health (sum)||||0.482
70865972|NCT03685123|141217614|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70865973|NCT03685123|141217615|SUPERIORITY|||||||0.37|||||||Mixed Models Analysis|||||||0.37
70865974|NCT03685123|141217616|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Change in body fat||||<0.001
70865975|NCT03685123|141217617|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70865976|NCT03685123|141217618|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||LDL||||0.004
70865977|NCT03685123|141217618|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||Change in HDL||||0.04
70865978|NCT03685123|141217618|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Change in Total Cholesterol||||<0.001
70865979|NCT03685123|141217618|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Triglycerides||||<0.001
70865980|NCT03685123|141217619|SUPERIORITY|||||||0.01||||||Systolic blood pressure|Mixed Models Analysis|||||||0.01
70865981|NCT03685123|141217619|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||Diastolic blood pressure||||0.001
70865982|NCT03685123|141217619|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Aortic blood pressure (mmHg)||||<0.001
70865983|NCT03685123|141217619|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Change in aortic diastolic pressure||||<0.001
70865984|NCT03685123|141217620|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70865985|NCT03685123|141217621|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70865986|NCT03685123|141217622|SUPERIORITY|||||||0.366|||||||Mixed Models Analysis|||||||0.366
70865987|NCT03685123|141217623|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70865988|NCT03685123|141217625|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||||||0.004
70865989|NCT03685123|141217626|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70865990|NCT03685123|141217627|SUPERIORITY||||||<|0.001||||||General Health|Mixed Models Analysis|||||||<0.001
70865991|NCT03685123|141217627|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Physical Health||||<0.001
70865992|NCT03685123|141217627|SUPERIORITY|||||||0.023|||||||Mixed Models Analysis|||Role physical||||0.023
70865993|NCT03685123|141217627|SUPERIORITY||||||<|0.001||||||Bodily Pain|Mixed Models Analysis|||||||<0.001
70865994|NCT03685123|141217627|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Vitality||||<0.001
70865995|NCT03685123|141217627|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Social Functioning||||<0.001
70865996|NCT03685123|141217627|SUPERIORITY|||||||0.0105|||||||Mixed Models Analysis|||Mental Health||||0.0105
70865997|NCT03685123|141217627|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Role Emotional||||<0.001
70865998|NCT03685123|141217627|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||SF-36 mental health Components (sum)||||0.01
70865999|NCT03685123|141217627|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Physical Health Components Sum||||<0.001
70866000|NCT03685123|141217628|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Change in kilocalories consumed from baseline to week 10||||<0.001
70866001|NCT03685123|141217629|SUPERIORITY|||||||0.658|||||||Mixed Models Analysis|||Change in LDL Particle Size||||0.658
70866002|NCT03685123|141217629|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|||HDL participle size||||0.07
70866003|NCT02628938|141217642|SUPERIORITY_OR_OTHER|||||||0.299|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 15 minutes of the first use of Miswak extract mouth wash||||0.299
70866004|NCT02628938|141217642|SUPERIORITY_OR_OTHER|||||||0.007|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 7 days of using Miswak extract mouth wash||||0.007
70866005|NCT02628938|141217642|SUPERIORITY_OR_OTHER|||||||0.019|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 15 minutes of the first use of Miswak sticks||||0.019
70866006|NCT02628938|141217642|SUPERIORITY_OR_OTHER|||||||0|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 7 days of using Miswak sticks||||0.000
70866007|NCT02628938|141217642|SUPERIORITY_OR_OTHER|||||||0|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 15 minutes of the first use of Chlorohexidine gluconate mouth wash||||0.000
70866008|NCT02628938|141217642|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 7 days of using Chlorohexidine gluconate mouth wash||||0.001
70866009|NCT02628938|141217643|SUPERIORITY_OR_OTHER|||||||0.496|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 15 minutes of the first use of Miswak extract mouth wash||||0.496
70866010|NCT02628938|141217643|SUPERIORITY_OR_OTHER|||||||0.244|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 7 days of using Miswak extract mouth wash||||0.244
70866011|NCT02628938|141217643|SUPERIORITY_OR_OTHER|||||||0.19|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 15 minutes of the first use of Miswak sticks||||0.19
70866012|NCT02628938|141217643|SUPERIORITY_OR_OTHER|||||||0.829|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 7 days of of using Miswak sticks||||0.829
70866013|NCT02628938|141217643|SUPERIORITY_OR_OTHER|||||||0.341|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 15 minutes of the first use of Chlorohexidine gluconate mouth wash||||0.341
70866014|NCT02628938|141217643|SUPERIORITY_OR_OTHER|||||||0.82|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 7 days of using Chlorohexidine gluconate mouth wash||||0.82
70866015|NCT02628938|141217644|SUPERIORITY_OR_OTHER|||||||0.008|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Self-assessment scores after 7 days of using Miswak extract mouth wash||||0.008
70866016|NCT02628938|141217644|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Self-assessment scores after 7 days of using Miswak sticks||||0.001
70866017|NCT02628938|141217644|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Self-assessment scores after 7 days of using Chlorohexidine gluconate mouth wash||||0.02
70866018|NCT03113916|141217645|SUPERIORITY||Slope|2.63|||=|0.001|TWO_SIDED|95.0|1.05|4.2|||Mixed Models Analysis|||||4.20|1.05|=.001
70866019|NCT03113916|141217646|SUPERIORITY||Slope|-0.49||||0.23|TWO_SIDED|95.0|-1.29|0.31|||Mixed Models Analysis|||||0.31|-1.29|.23
70866020|NCT03113916|141217647|SUPERIORITY||Slope|0.000000676||||0.06|TWO_SIDED|95.0|-0.00000002|0.00000137|||Mixed Models Analysis|||||.00000137|-.00000002|.06
70866021|NCT03113916|141217648|SUPERIORITY||Slope|-5.64||||0.29|TWO_SIDED|95.0|-16.0|4.73|||Mixed Models Analysis||Values given need to be multiplied by 10 to the power of -10 (i.e., x 10\^-10).|||4.73|-16|.29
70866022|NCT03113916|141217649|SUPERIORITY||Slope|0.351||||0.27|TWO_SIDED|95.0|-0.277|0.978|||Mixed Models Analysis|||||.978|-.277|.27
70866023|NCT03113916|141217650|SUPERIORITY||Slope|-0.015||||0.1|TWO_SIDED|95.0|-0.032|0.003|||Mixed Models Analysis|||||.003|-.032|.10
70866024|NCT03113916|141217651|SUPERIORITY||Slope|-11.2||||0.07|TWO_SIDED|95.0|-23.0|0.7|||Mixed Models Analysis|||||0.7|-23.0|.07
70866025|NCT03113916|141217652|SUPERIORITY||Slope|-0.63||||0.12|TWO_SIDED|95.0|-1.41|0.16|||Mixed Models Analysis|||||0.16|-1.41|.12
70866026|NCT03113916|141217653|SUPERIORITY||Slope|0.174||||0.008|TWO_SIDED|95.0|0.05|0.302|||Mixed Models Analysis|||||.302|.050|.008
70866027|NCT03113916|141217654|SUPERIORITY||Slope|0.015||||0.5|TWO_SIDED|95.0|-0.029|0.059|||Mixed Models Analysis|||||.059|-.029|.50
70866028|NCT03113916|141217655|SUPERIORITY||Slope|-0.00003||||0.99|TWO_SIDED|95.0|-0.013|0.013|||Mixed Models Analysis|||||.013|-.013|.99
70866029|NCT01758523|141217667|OTHER|||||||0.002|||||||Mixed Models Analysis|||||||0.002
70866030|NCT01758523|141217668|OTHER|||||||0.028|||||||Mixed Models Analysis|||||||0.028
70866031|NCT01758523|141217669|OTHER||Odds Ratio (OR)|2.49||||0.057|TWO_SIDED|95.0|0.96|6.45|||Chi-squared|||||6.45|0.96|0.057
70866032|NCT01758523|141217670|OTHER||Odds Ratio (OR)|5.5||||0.007|TWO_SIDED|95.0|1.5|20.7|||Fisher Exact|||||20.7|1.5|0.007
70866033|NCT01758523|141217671|OTHER|||||||0.87||||||significance for drug x AKR1C3\*2 G-carrier genotype|Mixed Models Analysis|||||||0.87
70866034|NCT01758523|141217672|OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.030
70948623|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.5||||0.8092|TWO_SIDED|95.0|0.1|2.8|||ANOVA|||Day 56||2.8|0.1|0.8092
70948624|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|9.1||||0.004|TWO_SIDED|95.0|1.7|48.5|||ANOVA|||Day 56||48.5|1.7|0.0040
70866035|NCT00621959|141217673|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14||||0.546||95.0|-0.59|0.31||If the p-value of this estimated difference is lower than 5% the mean T5SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA including treatment and center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis for the primary endpoint is expressed as follows: 'The mean 24-hr reflective T5SS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.31|-0.59|0.546
70866036|NCT00621959|141217674|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08||||0.442||95.0|-0.27|0.12||If the p-value of this estimated difference is lower than 5% the mean change from baseline in overall RQLQ score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in overall RQLQ score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in overall RQLQ score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.12|-0.27|0.442
70866037|NCT03439657|141217683|NON_INFERIORITY|Upper limit (UL) of the 95% confidence interval (CI) for the anti-gE antibodies Geometric Mean Concentration (GMC) ratio between the Control group and the Co-Ad group should be \<1.5.|GMC ratio|1.07|||||TWO_SIDED|95.0|0.99|1.16|||ANCOVA|The 95% CI of the group GMCs ratio was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-gE GMCs (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean concentrations (GMCs) for anti-gE antibodies, one month after the administration of last vaccine dose.||1.16|0.99|
70866038|NCT03439657|141217684|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.04|||||TWO_SIDED|95.0|0.82|1.33|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-1), one month after the administration of Prevnar 13 vaccine dose.||1.33|0.82|
70866039|NCT03439657|141217684|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.02|||||TWO_SIDED|95.0|0.86|1.22|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-3), one month after the administration of Prevnar 13 vaccine dose.||1.22|0.86|
70866040|NCT03439657|141217684|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.25|||||TWO_SIDED|95.0|1.02|1.52|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-4), one month after the administration of Prevnar 13 vaccine dose.||1.52|1.02|
70866041|NCT03439657|141217684|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.04|||||TWO_SIDED|95.0|0.81|1.32|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-5), one month after the administration of Prevnar 13 vaccine dose.||1.32|0.81|
70866042|NCT03439657|141217684|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.26|||||TWO_SIDED|95.0|1.02|1.56|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-6A), one month after the administration of Prevnar 13 vaccine dose.||1.56|1.02|
70866043|NCT03439657|141217684|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.36|||||TWO_SIDED|95.0|1.07|1.73|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-6B), one month after the administration of Prevnar 13 vaccine dose.||1.73|1.07|
70866044|NCT03439657|141217684|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.21|||||TWO_SIDED|95.0|1.01|1.44|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-7F), one month after the administration of Prevnar 13 vaccine dose.||1.44|1.01|
70866045|NCT03439657|141217684|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.16|||||TWO_SIDED|95.0|0.97|1.39|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-9V), one month after the administration of Prevnar 13 vaccine dose.||1.39|0.97|
70866046|NCT03439657|141217684|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.15|||||TWO_SIDED|95.0|0.94|1.42|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-14), one month after the administration of Prevnar 13 vaccine dose.||1.42|0.94|
71140264|NCT03192176|141778523|SUPERIORITY||LSMean difference|18.1|STANDARD_ERROR_OF_MEAN|6.8||0.0082|TWO_SIDED|95.0|4.72|31.5||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||31.50|4.72|0.0082
71140265|NCT03192176|141778523|SUPERIORITY||LSMean difference|25.2|STANDARD_ERROR_OF_MEAN|6.85||0.0003|TWO_SIDED|95.0|11.77|38.71||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||38.71|11.77|0.0003
71140266|NCT03192176|141778523|SUPERIORITY||LSMean difference|30.6|STANDARD_ERROR_OF_MEAN|6.96|<|0.0001|TWO_SIDED|95.0|16.93|44.31||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||44.31|16.93|<0.0001
71140267|NCT03192176|141778523|SUPERIORITY||LSMean difference|11.2|STANDARD_ERROR_OF_MEAN|6.93||0.1074|TWO_SIDED|95.0|-2.45|24.84||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||24.84|-2.45|0.1074
71140268|NCT03192176|141778523|SUPERIORITY||LSMean difference|18.3|STANDARD_ERROR_OF_MEAN|6.83||0.0077|TWO_SIDED|95.0|4.87|31.76||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||31.76|4.87|0.0077
71140269|NCT03192176|141778523|SUPERIORITY||LSMean difference|23.6|STANDARD_ERROR_OF_MEAN|6.79||0.0006|TWO_SIDED|95.0|10.29|37.01||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||37.01|10.29|0.0006
71140270|NCT03192176|141778523|SUPERIORITY||LSMean difference|11.8|STANDARD_ERROR_OF_MEAN|6.47||0.0689|TWO_SIDED|95.0|-0.92|24.53||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||24.53|-0.92|0.0689
71140271|NCT03192176|141778523|SUPERIORITY||LSMean difference|14.6|STANDARD_ERROR_OF_MEAN|6.46||0.025|TWO_SIDED|95.0|1.84|27.27||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||27.27|1.84|0.0250
71140272|NCT03192176|141778523|SUPERIORITY||LSMean difference|24.4|STANDARD_ERROR_OF_MEAN|6.51||0.0002|TWO_SIDED|95.0|11.54|37.17||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||37.17|11.54|0.0002
71140273|NCT03192176|141778523|SUPERIORITY||LSMean difference|29.6|STANDARD_ERROR_OF_MEAN|6.6|<|0.0001|TWO_SIDED|95.0|16.6|42.57||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||42.57|16.60|<0.0001
71140274|NCT03192176|141778523|SUPERIORITY||LSMean difference|8.4|STANDARD_ERROR_OF_MEAN|6.59||0.2041|TWO_SIDED|95.0|-4.58|21.36||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||21.36|-4.58|0.2041
71140275|NCT03192176|141778523|SUPERIORITY||LSMean difference|18.4|STANDARD_ERROR_OF_MEAN|6.5||0.0049|TWO_SIDED|95.0|5.62|31.2||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||31.20|5.62|0.0049
71140276|NCT03192176|141778523|SUPERIORITY||LSMean difference|20.7|STANDARD_ERROR_OF_MEAN|6.45||0.0015|TWO_SIDED|95.0|8.0|33.37||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||33.37|8.00|0.0015
71140277|NCT03192176|141778523|SUPERIORITY||LSMean difference|15.8|STANDARD_ERROR_OF_MEAN|6.66||0.0184|TWO_SIDED|95.0|2.68|28.89||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||28.89|2.68|0.0184
71140278|NCT03192176|141778523|SUPERIORITY||LSMean difference|12.8|STANDARD_ERROR_OF_MEAN|6.66||0.0551|TWO_SIDED|95.0|-0.28|25.93||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||25.93|-0.28|0.0551
71140279|NCT03192176|141778523|SUPERIORITY||LSMean difference|25.8|STANDARD_ERROR_OF_MEAN|6.73||0.0002|TWO_SIDED|95.0|12.51|39.0||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||39.00|12.51|0.0002
71140280|NCT03192176|141778523|SUPERIORITY||LSMean difference|31.6|STANDARD_ERROR_OF_MEAN|6.8|<|0.0001|TWO_SIDED|95.0|18.17|44.93||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||44.93|18.17|<0.0001
70866047|NCT03439657|141217684|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.11|||||TWO_SIDED|95.0|0.92|1.34|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-18C), one month after the administration of Prevnar 13 vaccine dose.||1.34|0.92|
70866048|NCT03439657|141217684|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.03|||||TWO_SIDED|95.0|0.87|1.22|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-19A), one month after the administration of Prevnar 13 vaccine dose.||1.22|0.87|
70866049|NCT03439657|141217684|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.09|||||TWO_SIDED|95.0|0.9|1.32|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-19F), one month after the administration of Prevnar 13 vaccine dose.||1.32|0.90|
70866050|NCT03439657|141217684|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.2|||||TWO_SIDED|95.0|0.96|1.5|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-23F), one month after the administration of Prevnar 13 vaccine dose.||1.50|0.96|
70866051|NCT00502944|141217698|SUPERIORITY_OR_OTHER||Rate Difference (%)|30.0|||<|0.001|TWO_SIDED|95.0|27.0|32.0|||Chi-squared|||HIV test completed among patients randomized||32|27|<0.001
70866052|NCT00502944|141217699|SUPERIORITY_OR_OTHER||Rate Difference (%)|44.0|||<|0.001|TWO_SIDED|95.0|42.0|47.0|||Chi-squared|||HIV test offered||47|42|<0.001
70866053|NCT00502944|141217700|SUPERIORITY_OR_OTHER||Rate Difference (%)|-4.0||||0.02|TWO_SIDED|95.0|-8.0|-1.0|||Chi-squared|||HIV test accepted among patients offered||-1|-8|0.02
70866054|NCT02612129|141217729|SUPERIORITY||Least Square (LS) Mean Difference|-1.4||||0.0456|TWO_SIDED|95.0|-2.76|-0.03|||GLMM for Repeated Measures|||A general linear mixed model (GLMM) for repeated measurements was used for the analysis of NPC disease severity assessed based on the 5-domain NPCCSS scores at Month 12. The general linear mixed model analysis for repeated measures was fitted with treatment, miglustat level and visit as fixed effects including treatment-by-visit interaction and baseline score as a covariate.||-0.03|-2.76|0.0456
70866055|NCT02612129|141217730|SUPERIORITY|||||||1|||||||Chi-squared Test|||||||1.0000
70866056|NCT02612129|141217731|SUPERIORITY|||||||0.5456|||||||Chi-squared Test|||||||0.5456
70866057|NCT02612129|141217732|SUPERIORITY|||||||0.8021|||||||Log-Rank Test|||Log-rank test had been stratified by miglustat use.||||0.8021
70866058|NCT02612129|141217733|SUPERIORITY|||||||0.3662|||||||Fisher's Exact Test|||Percentage of participants worsening at Month 6||||0.3662
70866059|NCT02612129|141217733|SUPERIORITY|||||||1|||||||Fisher's Exact Test|||Percentage of participants worsening at Month 12||||1.0000
70866060|NCT02612129|141217734|SUPERIORITY||LS Mean Difference|-1.69||||0.1546|TWO_SIDED|95.0|-4.04|0.66|||ANCOVA|||Change From Baseline in 17-Domain NPCCSS Apart from Hearing Domains (i.e. Hearing and Auditory Brainstem Response) at Month 6 was analyzed using the Analysis of covariance (ANCOVA) model. ANCOVA model was fitted with treatment, baseline full-scale NPCCSS apart from hearing domains score, and use of miglustat as covariates.||0.66|-4.04|0.1546
70866061|NCT02612129|141217734|SUPERIORITY||LS Mean Difference|-1.61||||0.2199|TWO_SIDED|95.0|-4.24|1.01|||ANCOVA|||Change From Baseline in 17-Domain NPCCSS Apart from Hearing Domains (i.e. Hearing and Auditory Brainstem Response) at Month 12 was analyzed using the ANCOVA model. ANCOVA model is fitted with treatment, baseline full-scale NPCCSS apart from hearing domains score, and use of miglustat as covariates.||1.01|-4.24|0.2199
70866062|NCT02612129|141217735|SUPERIORITY||Least Square (LS) Mean Difference|-1.11||||0.0188|TWO_SIDED|95.0|-2.03|-0.19|||ANCOVA|||An ANCOVA model was fitted with treatment, baseline 5-domain NPCCSS score, and use of miglustat as covariates.||-0.19|-2.03|0.0188
70866063|NCT02612129|141217737|SUPERIORITY||LS Mean Difference|-5.09||||0.0536|TWO_SIDED|95.0|-10.26|0.08|||ANCOVA|||"Change from baseline in the NPC-CDB score (modified Stampfer Score) at Month 6 was analyzed using the ANCOVA model. ANCOVA model was fitted with treatment, baseline NPC-CDB total score and use of miglustat as covariates."||0.08|-10.26|0.0536
70866064|NCT02612129|141217737|SUPERIORITY||LS Mean Difference|-3.03||||0.3785|TWO_SIDED|95.0|-9.9|3.85|||ANCOVA|||"Change from baseline in the NPC-CDB score (modified Stampfer Score) at Month 12 was analyzed using the ANCOVA model. ANCOVA model was fitted with treatment, baseline NPC-CDB total score and use of miglustat as covariates."||3.85|-9.90|0.3785
70866065|NCT02612129|141217738|SUPERIORITY|||||||0.6951|||||||Chi-squared Test|||Percentage of participants with change from baseline at Month 6 in Quality of Life (EQ-5D-Y) being 'Better'||||0.6951
70866066|NCT02612129|141217738|SUPERIORITY|||||||0.7542|||||||Chi-squared Test|||Percentage of participants with change from baseline at Month 6 in Quality of Life (EQ-5D-Y) being 'Worse'||||0.7542
70866067|NCT02612129|141217738|SUPERIORITY|||||||0.488|||||||Chi-squared Test|||Percentage of participants with change from baseline at Month 12 in Quality of Life (EQ-5D-Y) being 'Better'||||0.4880
70866068|NCT02612129|141217738|SUPERIORITY|||||||0.1804|||||||Chi-squared Test|||Percentage of participants with change from baseline at Month 12 in Quality of Life (EQ-5D-Y) being 'Worse'||||0.1804
70866069|NCT02612129|141217739|SUPERIORITY||LS Mean Difference|0.74||||0.371|TWO_SIDED|95.0|-0.92|2.4|||ANCOVA|||Change from baseline in the SARA score at Month 6 was measured using an ANCOVA model. ANCOVA model was fitted with treatment, baseline SARA score, and use of miglustat as covariates.||2.40|-0.92|0.3710
70866070|NCT02612129|141217739|SUPERIORITY||LS Mean Difference|0.28||||0.7899|TWO_SIDED|95.0|-1.82|2.37|||ANCOVA|||Change from baseline in the SARA score at Month 12 was measured using an ANCOVA model. ANCOVA model was fitted with treatment, baseline SARA score and use of miglustat as covariates.||2.37|-1.82|0.7899
70866071|NCT02612129|141217740|SUPERIORITY||LS Mean Difference|-10.34||||0.6195|TWO_SIDED|95.0|-53.01|32.33|||ANCOVA|||Dominant Hand: Change From Baseline in the Nine-Hole Peg Test (9HPT) at Month 6 was measured using an ANCOVA model: ANCOVA models were fitted with treatment, baseline dominant/non-dominant hand 9HPT time (secs), and use of miglustat as covariates||32.33|-53.01|0.6195
70866072|NCT02612129|141217740|SUPERIORITY||LS Mean Difference|-15.87||||0.4693|TWO_SIDED|95.0|-60.73|29.0|||ANCOVA|||Non-dominant Hand: Change From Baseline in the Nine-Hole Peg Test (9HPT) at Month 6 was measured using an ANCOVA model: ANCOVA models were fitted with treatment, baseline dominant/non-dominant hand 9HPT time (secs), and use of miglustat as covariates||29.00|-60.73|0.4693
70866073|NCT02612129|141217740|SUPERIORITY||LS Mean Difference|3.2||||0.7283|TWO_SIDED|95.0|-15.71|22.12|||ANCOVA|||Dominant Hand: Change From Baseline in the Nine-Hole Peg Test (9HPT) at Month 12 was measured using an ANCOVA model: ANCOVA models were fitted with treatment, baseline dominant/non-dominant hand 9HPT time (secs), and use of miglustat as covariates||22.12|-15.71|0.7283
70866074|NCT02612129|141217740|SUPERIORITY||LS Mean Difference|-5.91||||0.7708|TWO_SIDED|95.0|-47.54|35.72|||ANCOVA|||Non-dominant Hand: Change From Baseline in the Nine-Hole Peg Test (9HPT) at Month 12 was measured using an ANCOVA model: ANCOVA models were fitted with treatment, baseline dominant/non-dominant hand 9HPT time (secs), and use of miglustat as covariates||35.72|-47.54|0.7708
70866075|NCT05764408|141217743|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.49|1.35||||||||1.35|0.49|
70866076|NCT05764408|141217744|SUPERIORITY||Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.39|1.86||||||||1.86|0.39|
71140281|NCT03192176|141778523|SUPERIORITY||LSMean difference|14.3|STANDARD_ERROR_OF_MEAN|6.79||0.0367|TWO_SIDED|95.0|0.89|27.62||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Wek 10||27.62|0.89|0.0367
71140282|NCT03192176|141778523|SUPERIORITY||LSMean difference|21.2|STANDARD_ERROR_OF_MEAN|6.7||0.0017|TWO_SIDED|95.0|7.99|34.34||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||34.34|7.99|0.0017
70866077|NCT05764408|141217745|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||||||0.47
70866078|NCT05764408|141217747|SUPERIORITY|||||||0.81|||||||t-test, 2 sided|||||||0.81
70866079|NCT05764408|141217748|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.07|16.12||||||||16.12|0.07|
70866080|NCT00531934|141217751|SUPERIORITY_OR_OTHER|||||||0.175|||||||Chi-squared|||||||0.175
70866081|NCT00531934|141217754|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Erlotinib + doxycycline vs Erlotinib: Grade 3 intensity skin rash (folliculitis)||||<0.001
70866082|NCT00531934|141217760|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.763||||0.143|TWO_SIDED|95.0|0.525|1.109|||Log Rank|||||1.109|0.525|0.143
70866083|NCT00531934|141217763|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.769||||0.153|TWO_SIDED|95.0|0.529|1.116|||Log Rank|||||1.116|0.529|0.153
70866084|NCT00531934|141217769|SUPERIORITY_OR_OTHER|||||||0.003|||||||Cochran-Mantel-Haenszel|||Erlotinib + doxycycline vs Erlotinib: Grade 3||||0.003
70866085|NCT02975336|141217899|SUPERIORITY||Odds Ratio (OR)|1.55||||0.5462|TWO_SIDED|95.0|0.91|2.64|||Regression, Logistic|||||2.64|0.91|0.5462
70866086|NCT02975336|141217899|SUPERIORITY||Odds Ratio (OR)|1.29||||0.5462|TWO_SIDED|95.0|0.76|2.18|||Regression, Logistic|||||2.18|0.76|0.5462
71140283|NCT03192176|141778523|SUPERIORITY||LSMean difference|24.4|STANDARD_ERROR_OF_MEAN|6.65||0.0003|TWO_SIDED|95.0|11.29|37.44||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||37.44|11.29|0.0003
70866087|NCT02975336|141217899|SUPERIORITY||Odds Ratio (OR)|1.13||||0.5462|TWO_SIDED|95.0|0.67|1.93|||Regression, Logistic|||||1.93|0.67|0.5462
70866088|NCT02975336|141217900|SUPERIORITY||Odds Ratio (OR)|1.5||||0.5462|TWO_SIDED|95.0|0.69|3.24|||Regression, Logistic|||||3.24|0.69|0.5462
70866089|NCT02975336|141217900|SUPERIORITY||Odds Ratio (OR)|1.42||||0.5462|TWO_SIDED|95.0|0.68|2.97|||Regression, Logistic|||||2.97|0.68|0.5462
70866090|NCT02975336|141217900|SUPERIORITY||Odds Ratio (OR)|1.27||||0.5462|TWO_SIDED|95.0|0.59|2.75|||Regression, Logistic|||||2.75|0.59|0.5462
70866091|NCT02975336|141217928|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.7034|TWO_SIDED|95.0|0.57|2.4|||Cox proportional hazards model|||||2.40|0.57|0.7034
70866092|NCT02975336|141217928|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.5462|TWO_SIDED|95.0|0.31|1.52|||Cox proportional hazards model|||||1.52|0.31|0.5462
70866093|NCT02975336|141217928|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.5462|TWO_SIDED|95.0|0.42|1.97|||Cox proportional hazards model|||||1.97|0.42|0.5462
70866094|NCT02975336|141217929|SUPERIORITY||Odds Ratio (OR)|1.52||||0.5462|TWO_SIDED|95.0|0.74|3.15|||Regression, Logistic|||||3.15|0.74|0.5462
70866095|NCT02975336|141217929|SUPERIORITY||Odds Ratio (OR)|1.03||||0.5462|TWO_SIDED|95.0|0.49|2.13|||Regression, Logistic|||||2.13|0.49|0.5462
70866096|NCT02975336|141217929|SUPERIORITY||Odds Ratio (OR)|1.35||||0.5462|TWO_SIDED|95.0|0.65|2.81|||Regression, Logistic|||||2.81|0.65|0.5462
70866097|NCT02975336|141217930|SUPERIORITY||Odds Ratio (OR)|1.6||||0.2434|TWO_SIDED|95.0|0.73|3.54|||Regression, Logistic|||||3.54|0.73|0.2434
70866098|NCT02975336|141217930|SUPERIORITY||Odds Ratio (OR)|1.62||||0.2389|TWO_SIDED|95.0|0.73|3.63|||Regression, Logistic|||||3.63|0.73|0.2389
70866099|NCT02975336|141217930|SUPERIORITY||Odds Ratio (OR)|1.71||||0.1952|TWO_SIDED|95.0|0.76|3.85|||Regression, Logistic|||||3.85|0.76|0.1952
70866100|NCT02975336|141217931|SUPERIORITY||Hazard Ratio (HR)|1.59||||0.0987|TWO_SIDED|95.0|0.87|2.89|||Cox proportional hazards model|||||2.89|0.87|0.0987
70866101|NCT02975336|141217931|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.9201|TWO_SIDED|95.0|0.51|1.85|||Cox proportional hazards model|||||1.85|0.51|0.9201
70866102|NCT02975336|141217931|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.5645|TWO_SIDED|95.0|0.6|2.2|||Cox proportional hazards model|||||2.20|0.60|0.5645
71140284|NCT03192176|141778523|SUPERIORITY||LSMean difference|14.5|STANDARD_ERROR_OF_MEAN|6.45||0.0255|TWO_SIDED|95.0|1.78|27.15||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||27.15|1.78|0.0255
71140285|NCT03192176|141778523|SUPERIORITY||LSMean difference|15.3|STANDARD_ERROR_OF_MEAN|6.45||0.0186|TWO_SIDED|95.0|2.57|27.94||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||27.94|2.57|0.0186
71140286|NCT03192176|141778523|SUPERIORITY||LSMean difference|26.5|STANDARD_ERROR_OF_MEAN|6.52|<|0.0001|TWO_SIDED|95.0|13.71|39.36||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||39.36|13.71|<0.0001
71140287|NCT03192176|141778523|SUPERIORITY||LSMean difference|29.9|STANDARD_ERROR_OF_MEAN|6.58|<|0.0001|TWO_SIDED|95.0|16.94|42.81||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||42.81|16.94|<0.0001
71140288|NCT03192176|141778523|SUPERIORITY||LSMean difference|13.9|STANDARD_ERROR_OF_MEAN|6.57||0.0347|TWO_SIDED|95.0|1.01|26.85||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||26.85|1.01|0.0347
71140289|NCT03192176|141778523|SUPERIORITY||LSMean difference|21.9|STANDARD_ERROR_OF_MEAN|6.48||0.0008|TWO_SIDED|95.0|9.16|34.65||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||34.65|9.16|0.0008
71140290|NCT03192176|141778523|SUPERIORITY||LSMean difference|23.4|STANDARD_ERROR_OF_MEAN|6.43||0.0003|TWO_SIDED|95.0|10.75|36.04||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||36.04|10.75|0.0003
71140291|NCT03192176|141778523|SUPERIORITY||LSMean difference|14.8|STANDARD_ERROR_OF_MEAN|6.43||0.0221|TWO_SIDED|95.0|2.13|27.43||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||27.43|2.13|0.0221
71140292|NCT03192176|141778523|SUPERIORITY||LSMean difference|17.0|STANDARD_ERROR_OF_MEAN|6.43||0.0087|TWO_SIDED|95.0|4.32|29.62||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||29.62|4.32|0.0087
71140293|NCT03192176|141778523|SUPERIORITY||LSMean difference|26.4|STANDARD_ERROR_OF_MEAN|6.5|<|0.0001|TWO_SIDED|95.0|13.65|39.23||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||39.23|13.65|<0.0001
71140294|NCT03192176|141778523|SUPERIORITY||LSMean difference|31.0|STANDARD_ERROR_OF_MEAN|6.56|<|0.0001|TWO_SIDED|95.0|18.13|43.94||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||43.94|18.13|<0.0001
71140295|NCT03192176|141778523|SUPERIORITY||LSMean difference|14.8|STANDARD_ERROR_OF_MEAN|6.55||0.0244|TWO_SIDED|95.0|1.92|27.7||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||27.70|1.92|0.0244
71140296|NCT03192176|141778523|SUPERIORITY||LSMean difference|21.9|STANDARD_ERROR_OF_MEAN|6.46||0.0008|TWO_SIDED|95.0|9.21|34.62||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||34.62|9.21|0.0008
71140297|NCT03192176|141778523|SUPERIORITY||LSMean difference|23.2|STANDARD_ERROR_OF_MEAN|6.41||0.0003|TWO_SIDED|95.0|10.63|35.83||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||35.83|10.63|0.0003
70866103|NCT02975336|141217932|SUPERIORITY||Odds Ratio (OR)|0.77||||0.3743|TWO_SIDED|95.0|0.44|1.37|||Regression, Logistic|||||1.37|0.44|0.3743
70866104|NCT02975336|141217932|SUPERIORITY||Odds Ratio (OR)|0.88||||0.6445|TWO_SIDED|95.0|0.5|1.54|||Regression, Logistic|||||1.54|0.50|0.6445
70866105|NCT02975336|141217932|SUPERIORITY||Odds Ratio (OR)|0.72||||0.2634|TWO_SIDED|95.0|0.41|1.28|||Regression, Logistic|||||1.28|0.41|0.2634
70866106|NCT02975336|141217933|SUPERIORITY||Rate Ratio|1.59||||0.2989|TWO_SIDED|95.0|0.66|3.81||Nominal p-value|Negative binomial regression|||||3.81|0.66|0.2989
70866107|NCT02975336|141217933|SUPERIORITY||Rate Ratio|0.85||||0.7325|TWO_SIDED|95.0|0.33|2.19||Nominal p-value|Negative binomial regression|||||2.19|0.33|0.7325
70866108|NCT02975336|141217933|SUPERIORITY||Rate Ratio|1.29||||0.591|TWO_SIDED|95.0|0.51|3.22||Nominal p-value|Negative binomial regression|||||3.22|0.51|0.5910
70866109|NCT02975336|141217934|SUPERIORITY||Odds Ratio (OR)|1.33||||0.3635|TWO_SIDED|95.0|0.72|2.47|||Regression, Logistic|||||2.47|0.72|0.3635
70866110|NCT02975336|141217934|SUPERIORITY||Odds Ratio (OR)|1.94||||0.0329|TWO_SIDED|95.0|1.06|3.56|||Regression, Logistic|||||3.56|1.06|0.0329
71140298|NCT03192176|141778523|SUPERIORITY||LSMean difference|9.8|STANDARD_ERROR_OF_MEAN|7.38||0.1871|TWO_SIDED|95.0|-4.77|24.3||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||24.30|-4.77|0.1871
70866111|NCT02975336|141217934|SUPERIORITY||Odds Ratio (OR)|1.1||||0.7619|TWO_SIDED|95.0|0.59|2.07|||Regression, Logistic|||||2.07|0.59|0.7619
70866112|NCT02975336|141217935|SUPERIORITY||Odds Ratio (OR)|1.36||||0.2642|TWO_SIDED|95.0|0.79|2.35|||Regression, Logistic|||||2.35|0.79|0.2642
71140299|NCT03192176|141778523|SUPERIORITY||LSMean difference|2.3|STANDARD_ERROR_OF_MEAN|7.38||0.7552|TWO_SIDED|95.0|-12.23|16.83||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMMRM|||Week 13||16.83|-12.23|0.7552
71140300|NCT03192176|141778523|SUPERIORITY||LSMean difference|1.5|STANDARD_ERROR_OF_MEAN|7.61||0.8407|TWO_SIDED|95.0|-13.44|16.5||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||16.50|-13.44|0.8407
71140301|NCT03192176|141778523|SUPERIORITY||LSMean difference|7.2|STANDARD_ERROR_OF_MEAN|7.6||0.345|TWO_SIDED|95.0|-7.77|22.14||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|LSMean difference|||Week 13||22.14|-7.77|0.3450
71140302|NCT03192176|141778523|SUPERIORITY||LSMean difference|5.7|STANDARD_ERROR_OF_MEAN|7.66||0.455|TWO_SIDED|95.0|-9.34|20.8||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||20.80|-9.34|0.4550
71140303|NCT03192176|141778523|SUPERIORITY||LSMean difference|10.4|STANDARD_ERROR_OF_MEAN|7.64||0.1747|TWO_SIDED|95.0|-4.64|25.44||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||25.44|-4.64|0.1747
71140304|NCT03192176|141778523|SUPERIORITY||LSMean difference|4.4|STANDARD_ERROR_OF_MEAN|7.38||0.5476|TWO_SIDED|95.0|-10.08|18.97||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||18.97|-10.08|0.5476
71140305|NCT03192176|141778523|SUPERIORITY||LSMean difference|2.1|STANDARD_ERROR_OF_MEAN|8.01||0.7954|TWO_SIDED|95.0|-13.69|17.84||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||17.84|-13.69|0.7954
71140306|NCT03192176|141778523|SUPERIORITY||LSMean differencce|1.3|STANDARD_ERROR_OF_MEAN|7.96||0.8731|TWO_SIDED|95.0|-14.41|16.95||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||16.95|-14.41|0.8731
71140307|NCT03192176|141778523|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|8.31||0.9689|TWO_SIDED|95.0|-16.68|16.03||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||16.03|-16.68|0.9689
71140308|NCT03192176|141778523|SUPERIORITY||LSMean difference|3.9|STANDARD_ERROR_OF_MEAN|8.28||0.6378|TWO_SIDED|95.0|-12.4|20.21||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||20.21|-12.40|0.6378
71140309|NCT03192176|141778523|SUPERIORITY||LSMean differencce|1.6|STANDARD_ERROR_OF_MEAN|8.33||0.8503|TWO_SIDED|95.0|-14.82|17.97||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||17.97|-14.82|0.8503
71140310|NCT03192176|141778523|SUPERIORITY||LSMean difference|13.0|STANDARD_ERROR_OF_MEAN|8.37||0.1224|TWO_SIDED|95.0|-3.51|29.44||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||29.44|-3.51|0.1224
71140311|NCT03192176|141778523|SUPERIORITY||LSMean difference|7.1|STANDARD_ERROR_OF_MEAN|7.99||0.3743|TWO_SIDED|95.0|-8.62|22.85||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||22.85|-8.62|0.3743
71140312|NCT03192176|141778523|SUPERIORITY||LSMean difference|-7.9|STANDARD_ERROR_OF_MEAN|7.89||0.3173|TWO_SIDED|95.0|-23.44|7.63||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||7.63|-23.44|0.3173
71140313|NCT03192176|141778523|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|7.82||0.7905|TWO_SIDED|95.0|-17.48|13.32||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||13.32|-17.48|0.7905
71140314|NCT03192176|141778523|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|8.24||0.3804|TWO_SIDED|95.0|-23.46|8.98||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||8.98|-23.46|0.3804
71140315|NCT03192176|141778523|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|8.11||0.4905|TWO_SIDED|95.0|-21.58|10.38||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||10.38|-21.58|0.4905
71140316|NCT03192176|141778523|SUPERIORITY||LSMean difference|-12.6|STANDARD_ERROR_OF_MEAN|8.25||0.1289|TWO_SIDED|95.0|-28.83|3.68||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||3.68|-28.83|0.1289
71140317|NCT03192176|141778523|SUPERIORITY||LSMean difference|6.4|STANDARD_ERROR_OF_MEAN|8.24||0.4398|TWO_SIDED|95.0|-9.86|22.61||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||22.61|-9.86|0.4398
71140318|NCT03192176|141778523|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|7.81||0.7921|TWO_SIDED|95.0|-17.45|13.33||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||13.33|-17.45|0.7921
71140319|NCT03192176|141778524|SUPERIORITY||LSMean difference|19.1|STANDARD_ERROR_OF_MEAN|7.28||0.009|TWO_SIDED|95.0|4.82|33.46||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|MMRM: Mixed Model Repeated Measures||Week 1||33.46|4.82|0.0090
71140320|NCT03192176|141778524|SUPERIORITY||LSMean difference|27.0|STANDARD_ERROR_OF_MEAN|7.32||0.0003|TWO_SIDED|95.0|12.61|41.39||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||41.39|12.61|0.0003
71140321|NCT03192176|141778524|SUPERIORITY||LSMean difference|39.5|STANDARD_ERROR_OF_MEAN|7.31|<|0.0001|TWO_SIDED|95.0|25.14|53.9||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||53.90|25.14|<0.0001
71140322|NCT03192176|141778524|SUPERIORITY||LSMean difference|44.8|STANDARD_ERROR_OF_MEAN|7.4|<|0.0001|TWO_SIDED|95.0|30.27|59.39||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||59.39|30.27|<0.0001
71140323|NCT03192176|141778524|SUPERIORITY||LSMean difference|12.2|STANDARD_ERROR_OF_MEAN|7.43||0.1019|TWO_SIDED|95.0|-2.43|26.79||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||26.79|-2.43|0.1019
71140324|NCT03192176|141778524|SUPERIORITY||LSMean difference|27.8|STANDARD_ERROR_OF_MEAN|7.31||0.0002|TWO_SIDED|95.0|13.45|42.22||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||42.22|13.45|0.0002
71140325|NCT03192176|141778524|SUPERIORITY||LSMean difference|29.5|STANDARD_ERROR_OF_MEAN|7.27|<|0.0001|TWO_SIDED|95.0|15.21|43.82||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||43.82|15.21|<0.0001
71140326|NCT03192176|141778524|SUPERIORITY||LSMean difference|19.9|STANDARD_ERROR_OF_MEAN|7.03||0.0049|TWO_SIDED|95.0|6.1|33.76||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||33.76|6.10|0.0049
71140327|NCT03192176|141778524|SUPERIORITY||LSMean difference|28.6|STANDARD_ERROR_OF_MEAN|7.07|<|0.0001|TWO_SIDED|95.0|14.64|42.46||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||42.46|14.64|<0.0001
71140328|NCT03192176|141778524|SUPERIORITY||LSMean differencce|33.8|STANDARD_ERROR_OF_MEAN|7.05|<|0.0001|TWO_SIDED|95.0|19.96|47.69||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||47.69|19.96|<0.0001
70948625|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.3||||0.3347|TWO_SIDED|95.0|0.1|1.8|||ANOVA|||Day 56||1.8|0.1|0.3347
70948626|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|5.6||||0.0488|TWO_SIDED|95.0|1.0|30.7|||ANOVA|||Day 56||30.7|1.0|0.0488
70948627|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|17.4||||0.0001|TWO_SIDED|95.0|3.3|92.2|||ANOVA|||Day 56||92.2|3.3|0.0001
71140329|NCT03192176|141778524|SUPERIORITY||LSMean difference|39.5|STANDARD_ERROR_OF_MEAN|7.16|<|0.0001|TWO_SIDED|95.0|25.4|53.58||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||53.58|25.40|<0.0001
71140330|NCT03192176|141778524|SUPERIORITY||LSMean difference|17.6|STANDARD_ERROR_OF_MEAN|7.17||0.0146|TWO_SIDED|95.0|3.5|31.7||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||31.70|3.50|0.0146
71140331|NCT03192176|141778524|SUPERIORITY||LSMean difference|24.1|STANDARD_ERROR_OF_MEAN|7.06||0.0007|TWO_SIDED|95.0|10.21|38.0||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||38.00|10.21|0.0007
71140332|NCT03192176|141778524|SUPERIORITY||LSMean difference|23.9|STANDARD_ERROR_OF_MEAN|7.03||0.0008|TWO_SIDED|95.0|10.05|37.7||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||37.70|10.05|0.0008
71140333|NCT03192176|141778524|SUPERIORITY||LSMean difference|23.2|STANDARD_ERROR_OF_MEAN|7.46||0.002|TWO_SIDED|95.0|8.56|37.9||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||37.90|8.56|0.0020
71140334|NCT03192176|141778524|SUPERIORITY||LSMean difference|34.4|STANDARD_ERROR_OF_MEAN|7.5|<|0.0001|TWO_SIDED|95.0|19.6|49.11||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||49.11|19.60|<0.0001
71140335|NCT03192176|141778524|SUPERIORITY||LSMean difference|35.6|STANDARD_ERROR_OF_MEAN|7.46|<|0.0001|TWO_SIDED|95.0|20.96|50.32||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||50.32|20.96|<0.0001
71140336|NCT03192176|141778524|SUPERIORITY||LSMean difference|43.0|STANDARD_ERROR_OF_MEAN|7.6|<|0.0001|TWO_SIDED|95.0|28.03|57.93||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||57.93|28.03|<0.0001
71140337|NCT03192176|141778524|SUPERIORITY||LSMean difference|25.4|STANDARD_ERROR_OF_MEAN|7.6||0.0009|TWO_SIDED|95.0|10.48|40.37||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||40.37|10.48|0.0009
71140338|NCT03192176|141778524|SUPERIORITY||LSMean difference|31.2|STANDARD_ERROR_OF_MEAN|7.48|<|0.0001|TWO_SIDED|95.0|16.49|45.9||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||45.90|16.49|<0.0001
70866113|NCT02975336|141217935|SUPERIORITY||Odds Ratio (OR)|1.49||||0.1489|TWO_SIDED|95.0|0.87|2.57|||Regression, Logistic|||||2.57|0.87|0.1489
70948628|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.8831|TWO_SIDED|95.0|0.1|3.0|||ANOVA|||Day 182||3.0|0.1|0.8831
70948629|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.2|5.2|||ANOVA|||Day 182||5.2|0.2|1.0000
70948630|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.8916|TWO_SIDED|95.0|0.1|3.1|||ANOVA|||Day 182||3.1|0.1|0.8916
70948631|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.9||||0.794|TWO_SIDED|95.0|0.4|9.9|||ANOVA|||Day 182||9.9|0.4|0.7940
71140339|NCT03192176|141778524|SUPERIORITY||LSMean difference|28.9|STANDARD_ERROR_OF_MEAN|7.44||0.0001|TWO_SIDED|95.0|14.24|43.52||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||43.52|14.24|0.0001
70948632|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.6||||0.9169|TWO_SIDED|95.0|0.3|8.9|||ANOVA|||Day 182||8.9|0.3|0.9169
70948633|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.2|5.2|||ANOVA|||Day 182||5.2|0.2|1.0000
70948634|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|3.3||||0.2563|TWO_SIDED|95.0|0.6|17.1|||ANOVA|||Day 182||17.1|0.6|0.2563
70948635|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.9237|TWO_SIDED|95.0|0.1|3.3|||ANOVA|||Day 182||3.3|0.1|0.9237
70948636|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.0||||0.7708|TWO_SIDED|95.0|0.4|10.8|||ANOVA|||Day 182||10.8|0.4|0.7708
70948637|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|3.3||||0.2661|TWO_SIDED|95.0|0.6|16.9|||ANOVA|||Day 182||16.9|0.6|0.2661
70948638|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.5||||0.7614|TWO_SIDED|95.0|0.1|2.6|||ANOVA|||Day 365||2.6|0.1|0.7614
70948639|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.8||||0.9905|TWO_SIDED|95.0|0.1|4.3|||ANOVA|||Day 365||4.3|0.1|0.9905
70948640|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.933|TWO_SIDED|95.0|0.1|3.3|||ANOVA|||Day 365||3.3|0.1|0.9330
70948641|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.3||||0.9945|TWO_SIDED|95.0|0.2|6.7|||ANOVA|||Day 365||6.7|0.2|0.9945
70948642|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.5||||0.9599|TWO_SIDED|95.0|0.3|8.4|||ANOVA|||Day 365||8.4|0.3|0.9599
70948643|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.3||||0.9942|TWO_SIDED|95.0|0.2|6.4|||ANOVA|||Day 365||6.4|0.2|0.9942
71140340|NCT03192176|141778524|SUPERIORITY||LSMean difference|23.1|STANDARD_ERROR_OF_MEAN|7.42||0.0021|TWO_SIDED|95.0|8.46|37.66||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||37.66|8.46|0.0021
71140341|NCT03192176|141778524|SUPERIORITY||LSMean difference|32.1|STANDARD_ERROR_OF_MEAN|7.45|<|0.0001|TWO_SIDED|95.0|17.42|46.71||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||46.71|17.42|<0.0001
71140342|NCT03192176|141778524|SUPERIORITY||LSMean difference|31.3|STANDARD_ERROR_OF_MEAN|7.42|<|0.0001|TWO_SIDED|95.0|16.73|45.91||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||45.91|16.73|<0.0001
71140343|NCT03192176|141778524|SUPERIORITY||LSMean difference|41.8|STANDARD_ERROR_OF_MEAN|7.56|<|0.0001|TWO_SIDED|95.0|26.95|56.68||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||56.68|26.95|<0.0001
71140344|NCT03192176|141778524|SUPERIORITY||LSMean difference|25.6|STANDARD_ERROR_OF_MEAN|7.54||0.0008|TWO_SIDED|95.0|10.77|40.43||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||40.43|10.77|0.0008
71140345|NCT03192176|141778524|SUPERIORITY||LSMean difference|31.3|STANDARD_ERROR_OF_MEAN|7.42|<|0.0001|TWO_SIDED|95.0|16.75|45.94||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||45.94|16.75|<0.0001
71140346|NCT03192176|141778524|SUPERIORITY||LSMean difference|29.4|STANDARD_ERROR_OF_MEAN|7.39|<|0.0001|TWO_SIDED|95.0|14.91|43.97||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||43.97|14.91|<0.0001
71140347|NCT03192176|141778524|SUPERIORITY||LSMean difference|20.2|STANDARD_ERROR_OF_MEAN|7.05||0.0045|TWO_SIDED|95.0|6.31|34.06||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||34.06|6.31|0.0045
71140348|NCT03192176|141778524|SUPERIORITY||LSMean difference|30.6|STANDARD_ERROR_OF_MEAN|7.07|<|0.0001|TWO_SIDED|95.0|16.68|44.49||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||44.49|16.68|<0.0001
71140349|NCT03192176|141778524|SUPERIORITY||LSMean difference|29.1|STANDARD_ERROR_OF_MEAN|7.08|<|0.0001|TWO_SIDED|95.0|15.14|42.98||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||42.98|15.14|<0.0001
71140350|NCT03192176|141778524|SUPERIORITY||LSMean difference|40.1|STANDARD_ERROR_OF_MEAN|7.19|<|0.0001|TWO_SIDED|95.0|25.96|54.26||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||54.26|25.96|<0.0001
70866114|NCT02975336|141217935|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9285|TWO_SIDED|95.0|0.56|1.7|||Regression, Logistic|||||1.70|0.56|0.9285
70866115|NCT02975336|141217938|SUPERIORITY||Odds Ratio (OR)|0.96||||0.9061|TWO_SIDED|95.0|0.49|1.88|||Regression, Logistic|||||1.88|0.49|0.9061
70866116|NCT02975336|141217938|SUPERIORITY||Odds Ratio (OR)|1.19||||0.6053|TWO_SIDED|95.0|0.61|2.31|||Regression, Logistic|||||2.31|0.61|0.6053
71140351|NCT03192176|141778524|SUPERIORITY||LSMean difference|24.4|STANDARD_ERROR_OF_MEAN|7.15||0.0007|TWO_SIDED|95.0|10.28|38.42||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||38.42|10.28|0.0007
71140352|NCT03192176|141778524|SUPERIORITY||LSMean difference|26.7|STANDARD_ERROR_OF_MEAN|7.06||0.0002|TWO_SIDED|95.0|1.78|40.55||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||40.55|1.78|0.0002
71140353|NCT03192176|141778524|SUPERIORITY||LSMean difference|23.4|STANDARD_ERROR_OF_MEAN|7.03||0.001|TWO_SIDED|95.0|9.55|37.22||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||37.22|9.55|0.0010
71140354|NCT03192176|141778524|SUPERIORITY||LSMean difference|19.1|STANDARD_ERROR_OF_MEAN|6.6||0.004|TWO_SIDED|95.0|6.13|32.11||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||32.11|6.13|0.0040
71140355|NCT03192176|141778524|SUPERIORITY||LSMean difference|23.8|STANDARD_ERROR_OF_MEAN|6.62||0.0004|TWO_SIDED|95.0|10.8|36.83||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||36.83|10.80|0.0004
71140356|NCT03192176|141778524|SUPERIORITY||LSMean difference|27.2|STANDARD_ERROR_OF_MEAN|6.64|<|0.0001|TWO_SIDED|95.0|14.1|40.24||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||40.24|14.10|<0.0001
71140357|NCT03192176|141778524|SUPERIORITY||LSMean difference|35.6|STANDARD_ERROR_OF_MEAN|6.75|<|0.0001|TWO_SIDED|95.0|22.34|48.88||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||48.88|22.34|<0.0001
71140358|NCT03192176|141778524|SUPERIORITY||LSMean difference|20.0|STANDARD_ERROR_OF_MEAN|6.72||0.0032|TWO_SIDED|95.0|6.76|33.19||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||33.19|6.76|0.0032
71140359|NCT03192176|141778524|SUPERIORITY||LSMean difference|24.1|STANDARD_ERROR_OF_MEAN|6.64||0.0003|TWO_SIDED|95.0|11.02|37.13||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||37.13|11.02|0.0003
71140360|NCT03192176|141778524|SUPERIORITY||LSMean difference|23.1|STANDARD_ERROR_OF_MEAN|6.59||0.0005|TWO_SIDED|95.0|10.17|36.08||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||36.08|10.17|0.0005
71140361|NCT03192176|141778524|SUPERIORITY||LSMean difference|17.6|STANDARD_ERROR_OF_MEAN|6.82||0.0102|TWO_SIDED|95.0|4.2|31.04||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||31.04|4.20|0.0102
71140362|NCT03192176|141778524|SUPERIORITY||LSMean difference|25.9|STANDARD_ERROR_OF_MEAN|6.83||0.0002|TWO_SIDED|95.0|12.42|39.29||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||39.29|12.42|0.0002
71140363|NCT03192176|141778524|SUPERIORITY||LSMean difference|25.8|STANDARD_ERROR_OF_MEAN|6.87||0.0002|TWO_SIDED|95.0|12.29|39.33||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||39.33|12.29|0.0002
71140364|NCT03192176|141778524|SUPERIORITY||LSMean difference|36.3|STANDARD_ERROR_OF_MEAN|6.97|<|0.0001|TWO_SIDED|95.0|22.58|49.98||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||49.98|22.58|<0.0001
71140365|NCT03192176|141778524|SUPERIORITY||LSMean difference|20.6|STANDARD_ERROR_OF_MEAN|6.94||0.0031|TWO_SIDED|95.0|7.0|34.29||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||34.29|7.00|0.0031
71140366|NCT03192176|141778524|SUPERIORITY||LSMean difference|22.9|STANDARD_ERROR_OF_MEAN|6.85||0.0009|TWO_SIDED|95.0|9.43|36.38||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||36.38|9.43|0.0009
71140367|NCT03192176|141778524|SUPERIORITY||LSMean difference|22.8|STANDARD_ERROR_OF_MEAN|6.8||0.0009|TWO_SIDED|95.0|9.42|36.19||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||36.19|9.42|0.0009
71140368|NCT03192176|141778524|SUPERIORITY||LSMean difference|13.8|STANDARD_ERROR_OF_MEAN|6.71||0.0408|TWO_SIDED|95.0|0.58|26.97||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||26.97|0.58|0.0408
70866117|NCT02975336|141217938|SUPERIORITY||Odds Ratio (OR)|0.8||||0.52|TWO_SIDED|95.0|0.4|1.59|||Regression, Logistic|||||1.59|0.40|0.5200
71140369|NCT03192176|141778524|SUPERIORITY||LSMean difference|20.0|STANDARD_ERROR_OF_MEAN|6.72||0.0031|TWO_SIDED|95.0|6.77|33.21||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||33.21|6.77|0.0031
71140370|NCT03192176|141778524|SUPERIORITY||LSMean difference|22.1|STANDARD_ERROR_OF_MEAN|6.76||0.0012|TWO_SIDED|95.0|8.8|35.4||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||35.40|8.80|0.0012
71140371|NCT03192176|141778524|SUPERIORITY||LSMean difference|29.9|STANDARD_ERROR_OF_MEAN|6.87|<|0.0001|TWO_SIDED|95.0|16.39|43.42||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||43.42|16.39|<0.0001
71140372|NCT03192176|141778524|SUPERIORITY||LSMean difference|14.9|STANDARD_ERROR_OF_MEAN|6.84||0.0303|TWO_SIDED|95.0|1.42|28.32||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||28.32|1.42|0.0303
70866118|NCT02975336|141217947|SUPERIORITY||Rate difference|5.9|||||TWO_SIDED|95.0|-9.7|21.2||||||||21.2|-9.7|
70866119|NCT02975336|141217947|SUPERIORITY||Rate Difference|0.6|||||TWO_SIDED|95.0|-14.5|15.6||||||||15.6|-14.5|
70866120|NCT02975336|141217947|SUPERIORITY||Rate difference|1.6|||||TWO_SIDED|95.0|-13.5|16.6||||||||16.6|-13.5|
70866121|NCT02975336|141217951|SUPERIORITY||Odds Ratio (OR)|1.14||||0.7728|TWO_SIDED|95.0|0.46|2.82|||Regression, Logistic|||||2.82|0.46|0.7728
70866122|NCT02975336|141217951|SUPERIORITY||Odds Ratio (OR)|0.66||||0.3314|TWO_SIDED|95.0|0.28|1.54|||Regression, Logistic|||||1.54|0.28|0.3314
70866123|NCT02975336|141217951|SUPERIORITY||Odds Ratio (OR)|0.85||||0.7205|TWO_SIDED|95.0|0.36|2.04|||Regression, Logistic|||||2.04|0.36|0.7205
70866124|NCT02975336|141217952|SUPERIORITY||Odds Ratio (OR)|1.13||||0.8364|TWO_SIDED|95.0|0.35|3.71|||Regression, Logistic|||||3.71|0.35|0.8364
70866125|NCT02975336|141217952|SUPERIORITY||Odds Ratio (OR)|1.13||||0.8287|TWO_SIDED|95.0|0.37|3.45|||Regression, Logistic|||||3.45|0.37|0.8287
71140373|NCT03192176|141778524|SUPERIORITY||LSMean difference|19.6|STANDARD_ERROR_OF_MEAN|6.75||0.004|TWO_SIDED|95.0|6.3|32.87||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||32.87|6.30|0.0040
70866126|NCT02975336|141217952|SUPERIORITY||Odds Ratio (OR)|1.21||||0.7621|TWO_SIDED|95.0|0.35|4.16|||Regression, Logistic|||||4.16|0.35|0.7621
70866127|NCT02975336|141217953|SUPERIORITY||Odds Ratio (OR)|0.88||||0.8464|TWO_SIDED|95.0|0.23|3.31|||Regression, Logistic|||||3.31|0.23|0.8464
71140374|NCT03192176|141778524|SUPERIORITY||LSMean difference|19.5|STANDARD_ERROR_OF_MEAN|6.71||0.0038|TWO_SIDED|95.0|6.34|32.73||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||32.73|6.34|0.0038
71140375|NCT03192176|141778524|SUPERIORITY||LSMean difference|16.0|STANDARD_ERROR_OF_MEAN|6.45||0.0137|TWO_SIDED|95.0|3.29|28.68||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||28.68|3.29|0.0137
71140376|NCT03192176|141778524|SUPERIORITY||LSMean difference|18.1|STANDARD_ERROR_OF_MEAN|6.45||0.0052|TWO_SIDED|95.0|5.44|30.82||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||30.82|5.44|0.0052
71140377|NCT03192176|141778524|SUPERIORITY||LSMean difference|22.6|STANDARD_ERROR_OF_MEAN|6.5||0.0006|TWO_SIDED|95.0|9.81|35.39||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||35.39|9.81|0.0006
71140378|NCT03192176|141778524|SUPERIORITY||LSMean difference|29.4|STANDARD_ERROR_OF_MEAN|6.58|<|0.0001|TWO_SIDED|95.0|16.41|42.32||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||42.32|16.41|<0.0001
71140379|NCT03192176|141778524|SUPERIORITY||LSMean difference|13.7|STANDARD_ERROR_OF_MEAN|6.57||0.0378|TWO_SIDED|95.0|0.78|26.63||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||26.63|0.78|0.0378
71140380|NCT03192176|141778524|SUPERIORITY||LSMean difference|20.1|STANDARD_ERROR_OF_MEAN|6.49||0.002|TWO_SIDED|95.0|7.31|32.85||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||32.85|7.31|0.002
71140381|NCT03192176|141778524|SUPERIORITY||LSMean difference|17.4|STANDARD_ERROR_OF_MEAN|6.44||0.0071|TWO_SIDED|95.0|4.77|30.09||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||30.09|4.77|0.0071
71140382|NCT03192176|141778524|SUPERIORITY||LSMean difference|20.7|STANDARD_ERROR_OF_MEAN|6.63||0.002|TWO_SIDED|95.0|7.61|33.71||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||33.71|7.61|0.0020
71140383|NCT03192176|141778524|SUPERIORITY||LSMean difference|18.7|STANDARD_ERROR_OF_MEAN|6.63||0.005|TWO_SIDED|95.0|5.68|31.79||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||31.79|5.68|0.0050
71140384|NCT03192176|141778524|SUPERIORITY||LSMean difference|24.4|STANDARD_ERROR_OF_MEAN|6.71||0.0003|TWO_SIDED|95.0|11.2|37.6||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||37.60|11.20|0.0003
71140385|NCT03192176|141778524|SUPERIORITY||LSMean difference|32.1|STANDARD_ERROR_OF_MEAN|6.77|<|0.0001|TWO_SIDED|95.0|18.77|45.42||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||45.42|18.77|<0.0001
71140386|NCT03192176|141778524|SUPERIORITY||LSMean difference|19.1|STANDARD_ERROR_OF_MEAN|6.76||0.005|TWO_SIDED|95.0|5.79|32.38||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Wek 10||32.38|5.79|0.0050
71140387|NCT03192176|141778524|SUPERIORITY||LSMean difference|23.1|STANDARD_ERROR_OF_MEAN|6.68||0.0006|TWO_SIDED|95.0|9.95|36.22||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||36.22|9.95|0.0006
70866128|NCT02975336|141217953|SUPERIORITY||Odds Ratio (OR)|0.59||||0.417|TWO_SIDED|95.0|0.16|2.12|||Regression, Logistic|||||2.12|0.16|0.4170
70866129|NCT02975336|141217953|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9988|TWO_SIDED|95.0|0.27|3.74|||Regression, Logistic|||||3.74|0.27|0.9988
70866130|NCT02975336|141217954|SUPERIORITY||Odds Ratio (OR)|1.13||||0.697|TWO_SIDED|95.0|0.62|2.04|||Regression, Logistic|||||2.04|0.62|0.6970
70866131|NCT02975336|141217954|SUPERIORITY||Odds Ratio (OR)|1.34||||0.3234|TWO_SIDED|95.0|0.75|2.42|||Regression, Logistic|||||2.42|0.75|0.3234
70866132|NCT02975336|141217954|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9846|TWO_SIDED|95.0|0.54|1.82|||Regression, Logistic|||||1.82|0.54|0.9846
70866133|NCT03917459|141217977|OTHER||LS mean of treatment difference|2.9|STANDARD_ERROR_OF_MEAN|2.94||0.3432|TWO_SIDED|95.0|-3.29|9.01|||Mixed Model Repeated Measures (MMRM)|||||9.01|-3.29|0.3432
70866134|NCT00075218|141217980|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.329|||<|0.001||95.0|0.233|0.466||The nominal levels of significance for the interim and final analyses were determined at the time of the analyses using the Lan-DeMets procedure with an O'Brien-Fleming stopping rule.|Log Rank|two-sided unstratified log-rank test||The study was designed to test the null hypothesis that the median TTP from placebo treatment is 4 months versus the alternative hypothesis that the median TTP from sunitinib treatment is at least 6 months with an overall 2-sided significance level of 0.05 and power of 90%.||0.466|0.233|<0.001
70866135|NCT00075218|141217981|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.347|||<|0.001||95.0|0.253|0.475||No p-value adjustment for multiple comparisons.|Log Rank|||||0.475|0.253|<0.001
70866136|NCT00075218|141217983|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.876||||0.306||95.0|0.679|1.129||No p-value adjustment for multiple comparisons.|Log Rank|||||1.129|0.679|0.306
70866137|NCT00075218|141217984|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.505||||0.306||95.0|0.262|1.134||No p-value adjustment for multiple comparisons.|Rank Preserving Structural Failure Time||95% CI for Hazard Ratio is from 2.5% and 97.5% Empirical Percentiles of 100,000 Bootstraps.|||1.134|0.262|0.306
71140388|NCT03192176|141778524|SUPERIORITY||LSMean difference|22.8|STANDARD_ERROR_OF_MEAN|6.62||0.0006|TWO_SIDED|95.0|9.79|35.85||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||35.85|9.79|0.0006
71140389|NCT03192176|141778524|SUPERIORITY||LSMean difference|18.5|STANDARD_ERROR_OF_MEAN|6.32||0.0036|TWO_SIDED|95.0|6.11|30.98||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||30.98|6.11|0.0036
71140390|NCT03192176|141778524|SUPERIORITY||LSMean difference|20.2|STANDARD_ERROR_OF_MEAN|6.32||0.0015|TWO_SIDED|95.0|7.77|32.65||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||32.65|7.77|0.0015
71140391|NCT03192176|141778524|SUPERIORITY||LSMean difference|25.0|STANDARD_ERROR_OF_MEAN|6.39||0.0001|TWO_SIDED|95.0|12.41|37.57||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||37.57|12.41|0.0001
71140392|NCT03192176|141778524|SUPERIORITY||LSMean difference|29.8|STANDARD_ERROR_OF_MEAN|6.45|<|0.0001|TWO_SIDED|95.0|17.12|42.49||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||42.49|17.12|<0.0001
70866138|NCT00075218|141217986|SUPERIORITY_OR_OTHER||rate (percentage)|6.6||||||95.0|3.8|10.5|||||Used exact method based on binomial distribution.|||10.5|3.8|
70866139|NCT00075218|141217986|SUPERIORITY_OR_OTHER||Treatment Difference (%)|6.58||||0.004||95.0|3.47|9.7||No p-value adjustment for multiple comparisons.|Pearson chi-square test|||||9.70|3.47|0.004
70866140|NCT00075218|141217989|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.339|||<|0.001||95.0|0.244|0.472||two-sided unstratified log-rank test|Log Rank|||||0.472|0.244|<0.001
70866141|NCT00075218|141217989|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.327|||<|0.001||95.0|0.232|0.46|||Log Rank|log-rank test of treatment stratified by prior imatinib mesylate response and McGill Pain Questionnaire's Present Pain Intensity score||Stratified log-rank test||0.460|0.232|<0.001
70866142|NCT00075218|141217990|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.972||||0.9322||95.0|0.508|1.86|||Log Rank|2-sided, unstratified log-rank test||||1.860|0.508|0.9322
70866143|NCT00075218|141217991|SUPERIORITY_OR_OTHER||Treatment Difference (percent)|17.3||||0.0046||95.0|6.7|28.0|||Pearson chi-square||95% CI of Difference based on normal distribution. Percent = (number of subjects with response per total subjects per treatment in defined analysis population)\*100.|||28.0|6.7|0.0046
70866144|NCT03469934|141218042|OTHER||Least Squares (LS) Mean Difference|-0.058||||0.5703|TWO_SIDED|95.0|-0.265|0.15|||Mixed-model repeated measures|||Mixed-model repeated measures (MMRM) analysis with fixed terms for treatment, time point of measurement, and treatment by time point interaction, baseline eosinophil count as a covariate, and a repeated time point effect within a participant.||0.150|-0.265|0.5703
70866145|NCT03469934|141218046|OTHER||LS Mean Difference|-0.05||||0.5901|TWO_SIDED|95.0|-0.239|0.139|||Mixed-model repeated measures|||MMRM analysis with fixed terms for treatment, time point of measurement, and treatment by time point interaction, baseline eosinophil count as a covariate, and a repeated time point effect within a participant.||0.139|-0.239|0.5901
70866146|NCT03469934|141218047|OTHER||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.164||0.596|TWO_SIDED|95.0|-0.25|0.43|||ANCOVA|||Change from baseline for FEV1 was compared between etokimab and placebo using an analysis of covariance (ANCOVA) with treatment as fixed effect and baseline result as covariate and participant as a random effect||0.43|-0.25|0.5960
70866147|NCT03469934|141218048|OTHER||LS Mean Difference|2.53|STANDARD_ERROR_OF_MEAN|9.823||0.7993|TWO_SIDED|95.0|-17.9|22.96|||ANCOVA|||Change from baseline for FeNO was compared between etokimab and placebo using an ANCOVA with treatment as fixed effect and baseline result as covariate and participant as a random effect||22.96|-17.90|0.7993
70866148|NCT02387710|141218068|OTHER||||||>|0.5|||||||Wilcoxon (Mann-Whitney)|||||||>0.5
71140393|NCT03192176|141778524|SUPERIORITY||LSMean difference|19.6|STANDARD_ERROR_OF_MEAN|6.43||0.0026|TWO_SIDED|95.0|6.9|32.21||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||32.21|6.90|0.0026
71140394|NCT03192176|141778524|SUPERIORITY||LSMean difference|23.4|STANDARD_ERROR_OF_MEAN|6.36||0.0003|TWO_SIDED|95.0|10.92|35.94||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||35.94|10.92|0.0003
71140395|NCT03192176|141778524|SUPERIORITY||LSMean difference|21.7|STANDARD_ERROR_OF_MEAN|6.3||0.0006|TWO_SIDED|95.0|9.34|34.14||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||34.14|9.34|0.0006
71140396|NCT03192176|141778524|SUPERIORITY||LSMean difference|19.3|STANDARD_ERROR_OF_MEAN|6.37||0.0026|TWO_SIDED|95.0|6.78|31.83||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||31.83|6.78|0.0026
71140397|NCT03192176|141778524|SUPERIORITY||LSMean difference|20.8|STANDARD_ERROR_OF_MEAN|6.36||0.0012|TWO_SIDED|95.0|8.29|33.33||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||33.33|8.29|0.0012
71140398|NCT03192176|141778524|SUPERIORITY||LSMean difference|25.1|STANDARD_ERROR_OF_MEAN|6.44||0.0001|TWO_SIDED|95.0|12.48|37.82||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||37.82|12.48|0.0001
71140399|NCT03192176|141778524|SUPERIORITY||LSMean difference|31.9|STANDARD_ERROR_OF_MEAN|6.5|<|0.0001|TWO_SIDED|95.0|19.11|44.67||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||44.67|19.11|<0.0001
71140400|NCT03192176|141778524|SUPERIORITY||LSMean difference|20.1|STANDARD_ERROR_OF_MEAN|6.48||0.0021|TWO_SIDED|95.0|7.32|32.81||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||32.81|7.32|0.0021
71140401|NCT03192176|141778524|SUPERIORITY||LSMean difference|22.7|STANDARD_ERROR_OF_MEAN|6.4||0.0004|TWO_SIDED|95.0|10.1|35.29||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||35.29|10.10|0.0004
71140402|NCT03192176|141778524|SUPERIORITY||LSMean difference|21.9|STANDARD_ERROR_OF_MEAN|6.34||0.0006|TWO_SIDED|95.0|9.42|34.38||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||34.38|9.42|0.0006
71140403|NCT03192176|141778524|SUPERIORITY||LSMean difference|17.0|STANDARD_ERROR_OF_MEAN|7.82||0.0304|TWO_SIDED|95.0|1.62|32.4||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||32.40|1.62|0.0304
71140404|NCT03192176|141778524|SUPERIORITY||LSMean difference|6.8|STANDARD_ERROR_OF_MEAN|7.82||0.3857|TWO_SIDED|95.0|-8.6|22.19||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMMRM|||Week 13||22.19|-8.60|0.3857
70866149|NCT02068027|141218169|SUPERIORITY|||||||0.4503||||||MMRM imputing for missing data|Mixed Models Analysis|||||||0.4503
70866150|NCT02068027|141218170|SUPERIORITY|||||||0.735||||||MMRM imputing for missing data|Mixed Models Analysis|||||||0.7350
70866151|NCT01032174|141218171|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The logistic regression model contained terms for treatment, gender and age.|Regression, Logistic|||||||<0.0001
70866152|NCT01032174|141218172|SUPERIORITY_OR_OTHER||Difference of Least Square Mean|1.06|STANDARD_ERROR_OF_MEAN|0.55||0.0568|TWO_SIDED|95.0|-0.03|2.15||The analysis of covariance (ANCOVA) model contained terms for treatment, gender, age and Body Mass Index (BMI).|ANCOVA|Least square mean was adjusted for gender, age and BMI.||||2.15|-0.03|0.0568
70866153|NCT01032174|141218173|SUPERIORITY_OR_OTHER|||||||0.0682|TWO_SIDED|||||The logistic regression model contained terms for treatment, gender and age.|Regression, Logistic|||||||0.0682
70866154|NCT00113087|141218178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.28|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.28
70866155|NCT00113087|141218179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.42||95.0|||||Mixed Models Analysis|||||||0.42
70866156|NCT00113087|141218180|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.64||||0.008||95.0|||||Mixed Models Analysis|||||||0.008
70866157|NCT00113087|141218181|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
70866158|NCT00113087|141218182|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Fisher Exact|||||||0.71
70866159|NCT00113087|141218183|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.74
70866160|NCT00113087|141218184|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.22
70866161|NCT00113087|141218185|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||t-test, 2 sided|||||||0.86
70866162|NCT00113087|141218186|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||t-test, 2 sided|||||||0.60
70866163|NCT00113087|141218187|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.60
70866164|NCT00113087|141218188|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||||||0.01
70866165|NCT00113087|141218189|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||t-test, 2 sided|||||||0.008
70866166|NCT00113087|141218190|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
70866167|NCT00113087|141218191|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.31
70866168|NCT00113087|141218192|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||t-test, 2 sided|||||||0.36
70866169|NCT00113087|141218193|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||t-test, 2 sided|||||||0.37
70866170|NCT00113087|141218194|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||t-test, 2 sided|||||||0.08
70866171|NCT00113087|141218195|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||t-test, 2 sided|||||||0.07
70866172|NCT00113087|141218196|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||||||0.05
70866173|NCT00113087|141218197|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||t-test, 2 sided|||||||0.11
70866174|NCT00113087|141218198|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||t-test, 2 sided|||||||0.49
70866175|NCT00113087|141218199|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||t-test, 2 sided|||||||0.35
70866176|NCT00113087|141218200|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||t-test, 2 sided|||||||0.62
70866177|NCT00113087|141218201|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||t-test, 2 sided|||||||0.43
70866178|NCT00113087|141218202|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||||||0.02
70866179|NCT00113087|141218203|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||t-test, 2 sided|||||||0.34
70866180|NCT00113087|141218204|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||t-test, 2 sided|||||||.81
70866181|NCT00113087|141218205|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Fisher Exact|||||||0.08
70866182|NCT00113087|141218206|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Fisher Exact|||||||0.06
70866183|NCT00810693|141218239|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Prespecified significance level for all significance tests was 5%. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy||Missing values for participants who withdrew/died before 12 weeks were imputed with worst value of 0m in case of death or clinical worsening without termination visit and with last observed value otherwise. Comparison was done using ANCOVA, with baseline 6MWD as a covariate and treatment group, region and treatment naive/add-on therapy as main effects. The primary statistical method was the stratified Wilcoxon test if the Shapiro-Wilk test for normality of residuals was statistically significant||||<0.0001
70866184|NCT00810693|141218239|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|35.78|||<|0.0001|TWO_SIDED|95.0|20.06|51.51||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||51.51|20.06|<0.0001
70866185|NCT00810693|141218239|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
70866186|NCT00810693|141218240|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, TTCW, Borg scale, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy||Missing values at week 12 were imputed using the last available post-baseline observation. Same analysis method as for primary efficacy parameter.||||<0.0001
70866187|NCT00810693|141218240|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-225.72|||<|0.0001|TWO_SIDED|95.0|-281.37|-170.08||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-170.08|-281.37|<0.0001
70866188|NCT00810693|141218240|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
70866189|NCT00810693|141218241|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||"Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.~Primary analysis due to result of Shapiro-Wilk test."|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy||Missing values at week 12 were imputed using the last available post-baseline observation. Same analysis method as for primary efficacy parameter.||||<0.0001
70866190|NCT00810693|141218241|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-431.81||||0.0157|TWO_SIDED|95.0|-781.52|-82.1||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-82.10|-781.52|0.0157
70866191|NCT00810693|141218241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
70866192|NCT00810693|141218242|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0033||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy||Missing values for participants who withdrew or died before 12 weeks were imputed with a worst value of IV in case of clinical worsening without termination visit or measurement at that termination visit and with a worst value of V in case of death and with the last observed value otherwise.||||0.0033
70866193|NCT00810693|141218243|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-5.2||||0.0046|TWO_SIDED|95.0|-9.85|-0.55||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.|Log Rank|Test was stratified by region and therapy naive/add-on therapy|Based on Mantel-Haenszel estimate stratified by region and therapy naive/add-on therapy.|"The test is for difference of occurence of Any event."||-0.55|-9.85|0.0046
70866194|NCT00810693|141218244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0022||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy||Missing values for participants who withdrew or died before 12 weeks were imputed with a worst value of 10 in case of death or clinical worsening without termination visit and with the last observed value otherwise.||||0.0022
70948644|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.5||||0.4932|TWO_SIDED|95.0|0.5|12.9|||ANOVA|||Day 365||12.9|0.5|0.4932
70948645|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.8||||0.9983|TWO_SIDED|95.0|0.2|4.6|||ANOVA|||Day 365||4.6|0.2|0.9983
70866195|NCT00810693|141218245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0663||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy.||Missing values at baseline were imputed using last available observation prior to start of study treatment. Missing values for participants who withdrew or died before 12 weeks were imputed with a worst value of -0.594 in case of death or clinical worsening without termination visit and with the last observed value otherwise.||||0.0663
70948646|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.7||||0.9112|TWO_SIDED|95.0|0.3|9.3|||ANOVA|||Day 365||9.3|0.3|0.9112
70948647|NCT03635086|141398243|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.0||||0.7431|TWO_SIDED|95.0|0.4|10.2|||ANOVA|||Day 365||10.2|0.4|0.7431
71140405|NCT03192176|141778524|SUPERIORITY||LSMean difference|7.5|STANDARD_ERROR_OF_MEAN|8.06||0.3497|TWO_SIDED|95.0|-8.31|23.4||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||23.40|-8.31|0.3497
71140406|NCT03192176|141778524|SUPERIORITY||LSMean difference|10.9|STANDARD_ERROR_OF_MEAN|8.05||0.1771|TWO_SIDED|95.0|-4.95|26.75||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|LSMean difference|||Week 13||26.75|-4.95|0.1771
71140407|NCT03192176|141778524|SUPERIORITY||LSMean difference|16.3|STANDARD_ERROR_OF_MEAN|8.1||0.0444|TWO_SIDED|95.0|0.41|32.29||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||32.29|0.41|0.0444
71140408|NCT03192176|141778524|SUPERIORITY||LSMean difference|11.7|STANDARD_ERROR_OF_MEAN|8.1||0.15|TWO_SIDED|95.0|-4.25|27.63||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||27.63|-4.25|0.1500
71140409|NCT03192176|141778524|SUPERIORITY||LSMean difference|3.9|STANDARD_ERROR_OF_MEAN|7.83||0.6196|TWO_SIDED|95.0|-11.51|19.29||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||19.29|-11.51|0.6196
71140410|NCT03192176|141778524|SUPERIORITY||LSMean difference|9.4|STANDARD_ERROR_OF_MEAN|8.48||0.2664|TWO_SIDED|95.0|-7.25|26.15||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||26.15|-7.25|0.2664
71140411|NCT03192176|141778524|SUPERIORITY||LSMean differencce|4.0|STANDARD_ERROR_OF_MEAN|8.44||0.6388|TWO_SIDED|95.0|-12.66|20.59||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||20.59|-12.66|0.6388
71140412|NCT03192176|141778524|SUPERIORITY||LSMean difference|4.9|STANDARD_ERROR_OF_MEAN|8.79||0.5797|TWO_SIDED|95.0|-12.43|22.19||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||22.19|-12.43|0.5797
71140413|NCT03192176|141778524|SUPERIORITY||LSMean difference|6.2|STANDARD_ERROR_OF_MEAN|8.78||0.4817|TWO_SIDED|95.0|-11.1|23.47||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||23.47|-11.10|0.4817
71140414|NCT03192176|141778524|SUPERIORITY||LSMean differencce|10.5|STANDARD_ERROR_OF_MEAN|8.8||0.2358|TWO_SIDED|95.0|-6.87|27.79||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||27.79|-6.87|0.2358
71140415|NCT03192176|141778524|SUPERIORITY||LSMean difference|14.3|STANDARD_ERROR_OF_MEAN|8.86||0.107|TWO_SIDED|95.0|-3.11|31.77||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||31.77|-3.11|0.1070
70866196|NCT00810693|141218245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06||||0.0197|TWO_SIDED|95.0|0.01|0.11||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||0.11|0.01|0.0197
70948648|NCT00513747|141398270|SUPERIORITY|||||||0.1521|||||||Log Rank|||||||0.1521
70948649|NCT00513747|141398271|SUPERIORITY|||||||0.0097|||||||Log Rank|||||||0.0097
70948650|NCT00513747|141398272|SUPERIORITY|||||||0.4645|||||||Log Rank|||||||0.4645
70948651|NCT01963169|141398297|SUPERIORITY||Effect size|0.54|||<|0.001|TWO_SIDED|||||\<0.05 (Threshold)|Mixed Models Analysis||The above values are for Knowledge outcome using the revised Osteoporosis Knowledge Test.|At 8 week, both intervention groups received the same Bone Power Program intervention. Thus, the analysis for the 8-week outcomes was completed as a two-armed RCT.||||< 0.001
70948652|NCT01963169|141398297|SUPERIORITY||Effect size|0.33|||<|0.001|TWO_SIDED|||||\<0.05 (threshold)|Mixed Models Analysis||The above values are for the exercise behavior variable assessed by the 9-item Self-Efficacy for Exercise scale.|At 8 weeks both intervention groups received the same BonePower intervention. Thus the analysis of 8-week outcome was completed as 2-armed RCT.||||<0.001
70948653|NCT01963169|141398297|SUPERIORITY||Effect size|0.2||||0.009|TWO_SIDED|||||\<0.05 (Threshold)|Mixed Models Analysis||The above values are for calcium outcome expectation..|At 8 weeks both intervention groups received the same BonePower intervention. Thus the analysis of 8-week outcome was completed as 2-armed RCT.||||0.009
70866197|NCT00810693|141218245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
71140416|NCT03192176|141778524|SUPERIORITY||LSMean difference|6.7|STANDARD_ERROR_OF_MEAN|8.47||0.4268|TWO_SIDED|95.0|-9.94|23.43||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||23.43|-9.94|0.4268
71140417|NCT03192176|141778524|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|8.61||0.9197|TWO_SIDED|95.0|-17.81|16.08||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||16.08|-17.81|0.9197
71140418|NCT03192176|141778524|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|8.54||0.9954|TWO_SIDED|95.0|-16.77|16.87||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||16.87|-16.77|0.9954
71140419|NCT03192176|141778524|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|9.0||0.9607|TWO_SIDED|95.0|-17.28|18.17||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||18.17|-17.28|0.9607
71140420|NCT03192176|141778524|SUPERIORITY||LSMean difference|-3.9|STANDARD_ERROR_OF_MEAN|8.87||0.6625|TWO_SIDED|95.0|-21.33|13.59||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||13.59|-21.33|0.6625
71140421|NCT03192176|141778524|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|9.01||0.9952|TWO_SIDED|95.0|-17.81|17.7||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||17.70|-17.81|0.9952
71140422|NCT03192176|141778524|SUPERIORITY||LSMean difference|7.6|STANDARD_ERROR_OF_MEAN|9.02||0.4001|TWO_SIDED|95.0|-10.16|25.36||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||25.36|-10.16|0.4001
71140423|NCT03192176|141778524|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|8.54||0.751|TWO_SIDED|95.0|-19.52|14.1||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||14.10|-19.52|0.7510
71140424|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|6.02||||0.0018|TWO_SIDED|95.0|1.95|18.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||18.64|1.95|0.0018
71140425|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|8.28||||0.0002|TWO_SIDED|95.0|2.7|25.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||25.42|2.70|0.0002
71140426|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|10.92|||<|0.0001|TWO_SIDED|95.0|3.53|33.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||33.74|3.53|<0.0001
71140427|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|12.18|||<|0.0001|TWO_SIDED|95.0|3.91|37.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||37.89|3.91|<0.0001
71140428|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|2.1||||0.2244|TWO_SIDED|95.0|0.64|6.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||6.92|0.64|0.2244
71140429|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|8.58||||0.0002|TWO_SIDED|95.0|2.77|26.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||26.53|2.77|0.0002
71140430|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|8.25||||0.0002|TWO_SIDED|95.0|2.71|25.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||25.13|2.71|0.0002
71140431|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|3.04||||0.0149|TWO_SIDED|95.0|1.24|7.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.45|1.24|0.0149
70948654|NCT01963169|141398297|SUPERIORITY||Effect Size|0.18||||0.002|TWO_SIDED|||||\<0.05 (Threshold)|Mixed Models Analysis||The above values are for exercise self-efficacy.|At 8 weeks both intervention groups received the same BonePower intervention. Thus the analysis of 8-week outcome was completed as 2-armed RCT.||||0.002
70948655|NCT01963169|141398297|SUPERIORITY||Effect size|0.14||||0.032|TWO_SIDED|||||\<0.05 (Threshold)|Mixed Models Analysis||The above values are for exercise outcome expectation.|At 8 weeks both intervention groups received the same BonePower intervention. Thus the analysis of 8-week outcome was completed as 2-armed RCT.||||0.032
70948656|NCT02353312|141398307|EQUIVALENCE|Pairwise comparisons of VO2 max means with equal variances between participant on and off treatment.||||||0.823|||||||t-test, 2 sided|||||||0.823
70948657|NCT04750577|141398313|OTHER|MMRM estimates were used as input for the MCP-Mod. including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit as well as random effects of patient.||||||0.0245|||||||MCP-Mod exponential model fit|Model assumption: 20% of the maximum effect is achieved at 3 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of BI 685509 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, quadratic, Emax and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.050). The total daily dose was considered for MCP-Mod analysis (placebo, active BI 685509 3 mg, 6 mg, and 9 mg).||||0.0245
71140432|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|4.65||||0.0011|TWO_SIDED|95.0|1.85|11.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||11.73|1.85|0.0011
71140433|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|6.36||||0.0001|TWO_SIDED|95.0|2.46|16.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||16.45|2.46|0.0001
71140434|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|6.87||||0.0001|TWO_SIDED|95.0|2.56|18.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||18.46|2.56|0.0001
71140435|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|2.18||||0.0897|TWO_SIDED|95.0|0.89|5.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.34|0.89|0.0897
71140436|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|3.46||||0.007|TWO_SIDED|95.0|1.42|8.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.53|1.42|0.0070
71140437|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|3.75||||0.0041|TWO_SIDED|95.0|1.52|9.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||9.23|1.52|0.0041
71140438|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|2.77||||0.0254|TWO_SIDED|95.0|1.13|6.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.78|1.13|0.0254
71140439|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0032|TWO_SIDED|95.0|1.59|10.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.04|1.59|0.0032
71140440|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|6.25||||0.0002|TWO_SIDED|95.0|2.37|16.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||16.51|2.37|0.0002
71140441|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|8.78|||<|0.0001|TWO_SIDED|95.0|3.0|25.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||25.70|3.00|<0.0001
70866198|NCT00810693|141218246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019||||||"Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO FC, TTCW, Borg scale, EQ5D, LPH.~Primary analysis due to result of Shapiro-Wilk test. Nominally significant only due to hierarchical testing."|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy.||Missing values at baseline were imputed using last available observation prior to start of study treatment. Missing values for participants who withdrew or died before 12 weeks were imputed with a worst value of 105 in case of death or clinical worsening without termination visit and with the last observed value otherwise.||||0.0019
70866199|NCT00810693|141218246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.17||||0.0009|TWO_SIDED|95.0|-9.79|-2.54||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-2.54|-9.79|0.0009
70866200|NCT00810693|141218246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
70866201|NCT02149719|141218264|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
70866202|NCT02345226|141218278|NON_INFERIORITY|A sample size of 400 HIV-1 infected participants per treatment group would provide 95% power to detect a non-inferiority margin of 8% in the Week 48 response rate difference between the FTC/RPV/TAF group and EFV/FTC/TDF group. For sample size and power computation, it is assumed that both treatment groups will have a response rate of 89% (based on Gilead Study GS-US-292-0109), that a noninferiority margin is 8%, and that the significance level of the test is at a one-sided alpha level of 0.025.|Difference in Percentages|-2.0|||||TWO_SIDED|95.001|-5.9|1.8|||||The difference in percentages and its 95.001% confidence interval (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The null hypothesis was that the percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 in the FTC/RPV/TAF group was at least 8% lower than the rate in the EFV/FTC/TDF group; the alternative hypothesis was that the percentage of participants with HIV-1 RNA \< 50 copies/mL in the FTC/RPV/TAF group was less than 8% lower than that in the EFV/FTC/TDF group.||1.8|-5.9|
70866203|NCT02345226|141218278|SUPERIORITY|||||||0.35|||||||Fisher Exact|||||||0.35
70866206|NCT03488355|141218389|SUPERIORITY||Risk Ratio (RR)|1.15||||0.45|TWO_SIDED||||||t-test, 2 sided|||||||0.45
70866207|NCT00516074|141218398|NON_INFERIORITY_OR_EQUIVALENCE|Approximately 25 subjects were intended to be randomized to both the exenatide and placebo arms. Assuming an approximate 24% dropout rate, 19 patients per treatment arm would complete the study. A sample of 19 patients per treatment group would provide 90% power to detect a 10 bpm difference between treatment groups in change in daily mean heart rate from baseline.||||||0.1585||95.0|||||ANCOVA|||||||0.1585
70866208|NCT00516074|141218399|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation for the primary endpoint is described as part of the primary endpoint information above.||||||0.1624||95.0|||||ANCOVA|||||||0.1624
71140442|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0214|TWO_SIDED|95.0|1.17|7.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.18|1.17|0.0214
71140443|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|3.67||||0.0049|TWO_SIDED|95.0|1.48|9.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.09|1.48|0.0049
71140444|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|3.36||||0.0078|TWO_SIDED|95.0|1.38|8.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.22|1.38|0.0078
71140445|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|2.28||||0.0727|TWO_SIDED|95.0|0.93|5.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.63|0.93|0.0727
71140446|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|2.94||||0.0199|TWO_SIDED|95.0|1.19|7.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.29|1.19|0.0199
71140447|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|4.21||||0.0034|TWO_SIDED|95.0|1.61|11.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||11.01|1.61|0.0034
71140448|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|6.26||||0.0007|TWO_SIDED|95.0|2.16|18.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||18.26|2.16|0.0007
71140449|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|2.02||||0.1206|TWO_SIDED|95.0|0.83|4.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||4.92|0.83|0.1206
71140450|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|3.58||||0.007|TWO_SIDED|95.0|1.42|9.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||9.03|1.42|0.0070
71140451|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|3.41||||0.0088|TWO_SIDED|95.0|1.36|8.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.54|1.36|0.0088
71140452|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|1.41||||0.4485|TWO_SIDED|95.0|0.58|3.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||3.40|0.58|0.4485
71140453|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|2.92||||0.0255|TWO_SIDED|95.0|1.14|7.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.47|1.14|0.0255
71140454|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|4.18||||0.0066|TWO_SIDED|95.0|1.49|11.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||11.75|1.49|0.0066
71140455|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|4.46||||0.0061|TWO_SIDED|95.0|1.53|13.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||13.01|1.53|0.0061
71140456|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|2.22||||0.0879|TWO_SIDED|95.0|0.89|5.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.57|0.89|0.0879
71140457|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|2.68||||0.0389|TWO_SIDED|95.0|1.05|6.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.83|1.05|0.0389
71140458|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0446|TWO_SIDED|95.0|1.02|6.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.73|1.02|0.0446
71140459|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8196|TWO_SIDED|95.0|0.45|2.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||2.72|0.45|0.8196
70866209|NCT00516074|141218400|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation for the primary endpoint is described as part of the primary endpoint information above.||||||0.5077||95.0|||||ANCOVA|||||||0.5077
70866210|NCT00516074|141218401|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation for the primary endpoint is described as part of the primary endpoint information above.||||||0.9034||95.0|||||ANCOVA|||||||0.9034
70866211|NCT00516074|141218402|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation for the primary endpoint is described as part of the primary endpoint information above.||||||0.427||95.0|||||ANCOVA|||||||0.4270
70866212|NCT00516074|141218403|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation for the primary endpoint is described as part of the primary endpoint information above.||||||0.26||95.0|||||ANCOVA|||||||0.2600
70866213|NCT02663908|141218433|OTHER||Hazard Ratio (HR)|1.283||||0.5294|TWO_SIDED|95.0|0.589|2.794|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||2.794|0.589|0.5294
70866214|NCT02663908|141218434|OTHER||Hazard Ratio (HR)|1.204||||0.7126|TWO_SIDED|95.0|0.448|3.234|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||3.234|0.448|0.7126
70866215|NCT02663908|141218435|OTHER||Hazard Ratio (HR)|0.186||||0.0853|TWO_SIDED|95.0|0.022|1.595|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||1.595|0.022|0.0853
70866216|NCT02663908|141218436|OTHER||Hazard Ratio (HR)|1.594||||0.5196|TWO_SIDED|95.0|0.381|6.673|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||6.673|0.381|0.5196
70866217|NCT02663908|141218437|OTHER||Hazard Ratio (HR)|0.899||||0.8966|TWO_SIDED|95.0|0.181|4.457|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||4.457|0.181|0.8966
70866218|NCT02663908|141218438|OTHER||Hazard Ratio (HR)|0.48||||0.3857|TWO_SIDED|95.0|0.088|2.62|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||2.620|0.088|0.3857
70866219|NCT02663908|141218439|OTHER||Hazard Ratio (HR)|0.839||||0.718|TWO_SIDED|95.0|0.324|2.176|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||2.176|0.324|0.7180
70866220|NCT02663908|141218441|OTHER||Hazard Ratio (HR)|0.887||||0.6701|TWO_SIDED|95.0|0.512|1.539|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||1.539|0.512|0.6701
70866221|NCT02663908|141218442|OTHER||Treatment Difference|-0.907||||0.1193|TWO_SIDED|95.0|-2.048|0.235|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||IPSS Total at Day 168||0.235|-2.048|0.1193
70866222|NCT02663908|141218442|OTHER||Treatment Difference|-0.213||||0.108|TWO_SIDED|95.0|-0.473|0.047|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||IPSS, QoL at Day 168||0.047|-0.473|0.1080
70866223|NCT02663908|141218442|OTHER||Treatment Difference|-0.916||||0.1256|TWO_SIDED|95.0|-2.089|0.257|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||IPSS Total at Day 336||0.257|-2.089|0.1256
70866224|NCT02663908|141218442|OTHER||Treatment Difference|-0.047||||0.7261|TWO_SIDED|95.0|-0.312|0.218|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||IPSS, QoL at Day 336||0.218|-0.312|0.7261
70866225|NCT02663908|141218446|OTHER||Treatment difference|-0.002||||0.911|TWO_SIDED|95.0|-0.036|0.032|||ANCOVA|Compared using an ANCOVA model, where the QALY is the dependent variable and adjusted for treatment group, age group and region, respectively.||||0.032|-0.036|0.9110
70866226|NCT02663908|141218447|OTHER||Treatment Difference|-1.57||||0.0936|TWO_SIDED|95.0|-3.41|0.27|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||DASI at Day 168||0.27|-3.41|0.0936
70866227|NCT02663908|141218447|OTHER||Treatment Difference|0.84||||0.4|TWO_SIDED|95.0|-1.11|2.78|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||DASI at Day 336||2.78|-1.11|0.4000
70866228|NCT02663908|141218448|OTHER||Treatment Difference|0.045||||0.2535|TWO_SIDED|95.0|-0.032|0.122|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ Global Score at Day 168||0.122|-0.032|0.2535
70866229|NCT02663908|141218448|OTHER||Treatment Difference|0.036||||0.437|TWO_SIDED|95.0|-0.055|0.127|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ domain score for Attention at Day 168||0.127|-0.055|0.4370
70866230|NCT02663908|141218448|OTHER||Treatment Difference|0.116||||0.0852|TWO_SIDED|95.0|-0.016|0.248|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ domain score for Avoidance at Day 168||0.248|-0.016|0.0852
70866231|NCT02663908|141218448|OTHER||Treatment Difference|0.012||||0.8156|TWO_SIDED|95.0|-0.087|0.111|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ domain score for Fear at Day 168||0.111|-0.087|0.8156
70866232|NCT02663908|141218448|OTHER||Treatment Difference|0.051||||0.2299|TWO_SIDED|95.0|-0.033|0.135|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ Global Score at Day 336||0.135|-0.033|0.2299
70866233|NCT02663908|141218448|OTHER||Treatment Difference|0.038||||0.444|TWO_SIDED|95.0|-0.06|0.136|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ domain score for Attention at Day 336||0.136|-0.060|0.4440
70866234|NCT02663908|141218448|OTHER||Treatment Difference|0.007||||0.9172|TWO_SIDED|95.0|-0.131|0.146|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ domain score for Avoidance at Day 336||0.146|-0.131|0.9172
70866235|NCT02663908|141218448|OTHER||Treatment Difference|0.093||||0.1028|TWO_SIDED|95.0|-0.019|0.204|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ domain score for Fear at Day 336||0.204|-0.019|0.1028
70866236|NCT00370071|141218465|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||one-sided p-value (one-sided test level 2.5%)|Wilcoxon-Signed-Rank test|||In this single arm study, the number of newly active lesions per 3 months during treatment was compared to the number of newly active lesions during 3-month pre-treatment (Alternative hypothesis: Number of lesions is reduced during treatment with Interferon beta-1b). The sample size was calculated for the use of the one-sided Wilcoxon-Signed-Rank test at level 2.5% (Power of 90% - anticipating P(X\&lt;Y)=0.15 and allowing for 25% exclusion from Per Protocol Set).||||<0.0001
70866237|NCT00370071|141218466|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||one-sided p-value (one-sided test level 2.5%)|Wilcoxon-Signed-Rank test|||||||<0.0001
70866238|NCT00370071|141218467|SUPERIORITY_OR_OTHER|||||||0.0017||95.0||||one-sided p-value (one-sided test level 2.5%)|Wilcoxon-Signed-Rank test|||||||0.0017
70948658|NCT04750577|141398313|OTHER|MMRM estimates were used as input for the MCP-Mod. including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit as well as random effects of patient.||||||0.0294|||||||MCP-Mod linear model fit|Model assumption: No assumption was needed.||A flat vs. non-flat dose-response relationship across the 3 doses of BI 685509 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, quadratic, Emax and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.050). The total daily dose was considered for MCP-Mod analysis (placebo, active BI 685509 3 mg, 6 mg, and 9 mg).||||0.0294
71140460|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|2.0||||0.145|TWO_SIDED|95.0|0.79|5.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.10|0.79|0.1450
71140461|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|4.08||||0.0114|TWO_SIDED|95.0|1.37|12.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||12.11|1.37|0.0114
70866239|NCT00370071|141218468|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon-Signed-Rank test|One-sided p-value from Wilcoxon-Signed-Rank-Test for comparing the baseline visit to treatment visits||Lesion volume at Week 12. 38 subjects were evaluated.||||<0.0001
70866240|NCT00370071|141218468|SUPERIORITY_OR_OTHER||||||=|0.0019|||||||Wilcoxon-Signed-Rank test|||Lesion volume at Week 24. 37 subjects were evaluated.||||=0.0019
70866241|NCT04508335|141218506|EQUIVALENCE|We use 2, one-sided t-tests, each with alpha set at 0.05 to test the composite null hypothesis that the mean difference score (μReia-μCurrent) between the Reia pessary and baseline (current pessary) on the PFDI-20, is greater than 18.3 (H01), the upper equivalence limit, or lower than -18.3 (H02), the lower equivalence limit.||||||0.0021|||||||t-test, 2 sided|||H01: μReia-μCurrent \> 18.3 and H02: μReia-μCurrent \< -18.3. The alternative hypothesis is thus: HA: -18.3 ≤ μReia-μCurrent ≤ 18.3.||||.0021
70866242|NCT04508335|141218508|OTHER|Mean difference of PFIQ scores. A negative difference (Reia pessary - current pessary) indicates that the PFIQ-7 score improved with the Reia pessary.|Mean Difference (Final Values)|-11.9||||0.0192|TWO_SIDED|||||p value adjusted for multiple variables|Wilcoxon (Mann-Whitney)|||PFIQ scores at baseline with subjects using current pessary then after treatment with Reia pessary||||0.0192
70866243|NCT00418015|141218530|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||Log Rank|||Log rank test||||0.54
70866244|NCT00418015|141218531|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||Log Rank|||||||0.15
70866245|NCT00418015|141218532|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared, Corrected|||||||0.06
70866246|NCT00418015|141218533|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Chi-squared, Corrected|||||||0.02
70866247|NCT00418015|141218534|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.23
70866248|NCT00418015|141218534|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.84
70866249|NCT00316719|141218538|NON_INFERIORITY_OR_EQUIVALENCE|This is a Non-inferiority Analysis with the margin of -1.0.|Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.309|<|0.001||95.0|-0.94|0.28|||ANCOVA|||||0.28|-0.94|<0.001
70866250|NCT02903355|141218551|SUPERIORITY|||||||0.4385|||||||Fisher Exact|||||||.4385
70866251|NCT02903355|141218552|SUPERIORITY|||||||0.5562|||||||Fisher Exact|||||||.5562
70866252|NCT02903355|141218553|SUPERIORITY|||||||0.5441|||||||Fisher Exact|||||||.5441
70866253|NCT02903355|141218554|SUPERIORITY|||||||0.3666|||||||Fisher Exact|||||||.3666
70866254|NCT02903355|141218555|SUPERIORITY|||||||0.4446|||||||Fisher Exact|||||||.4446
70866255|NCT02903355|141218556|SUPERIORITY|||||||0.5431|||||||Fisher Exact|||||||.5431
70866256|NCT02903355|141218557|SUPERIORITY|||||||0.7409|||||||Fisher Exact|||||||.7409
70866257|NCT02903355|141218558|SUPERIORITY|||||||0.1597|||||||Fisher Exact|||||||.1597
70866258|NCT02903355|141218559|SUPERIORITY|||||||0.2784|||||||t-test, 1 sided|||||||.2784
70866259|NCT02903355|141218560|SUPERIORITY|||||||0.2303|||||||Fisher Exact|||||||.2303
70866260|NCT00094172|141218602|SUPERIORITY_OR_OTHER|||||||0.929|||||||Log Rank|||This is the primary analysis of the primary endpoint||||0.929
70866261|NCT00094172|141218602|SUPERIORITY_OR_OTHER|||||||0.823|||||||Fisher Exact|||This is the secondary analysis of the primary endpoint||||0.823
70866262|NCT00094172|141218603|SUPERIORITY_OR_OTHER|||||||0.208|||||||Log Rank|||||||.208
70866263|NCT00094172|141218604|SUPERIORITY_OR_OTHER|||||||0.526||95.0|||||Log Rank|||||||0.526
70866264|NCT02478632|141218613|SUPERIORITY||Mean Difference (Final Values)|1.29||||0.014|TWO_SIDED|95.0|0.27|2.31|||ANCOVA|||||2.31|0.27|0.014
70866265|NCT02478632|141218614|SUPERIORITY||Mean Difference (Final Values)|1.32||||0.039|TWO_SIDED|95.0|0.07|2.57|||ANCOVA|||||2.57|0.07|0.039
70866266|NCT02478632|141218617|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.016|TWO_SIDED|95.0|0.02|0.16||p value for the difference in adjusted change from Baseline at Week 48 in total hip T-scores between the DTG+RPV and CAR groups|ANCOVA||The analysis estimated the difference between DTG+RPV and CAR in total hip T-scores|||0.16|0.02|0.016
70866267|NCT02478632|141218617|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.026|TWO_SIDED|95.0|0.01|0.15||p value for the difference in adjusted change from Baseline at Week 48 in total hip Z-scores between the DTG+RPV and CAR groups|ANCOVA||The analysis estimated difference between DTG+RPV and CAR in total hip Z-score.|||0.15|0.01|0.026
70866268|NCT02478632|141218617|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.049|TWO_SIDED|95.0|0.0|0.23||p value for the difference in adjusted change from Baseline at Week 48 in lumbar spine T-scores between the DTG+RPV and CAR groups|ANCOVA||The analysis estimated difference between DTG+RPV and CAR for lumbar spine T-score.|||0.23|0.00|0.049
70948659|NCT04750577|141398313|OTHER|A flat vs. non-flat dose-response relationship across the 3 doses of BI 685509 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, quadratic, Emax and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.050). The total daily dose was considered for MCP-Mod analysis (placebo, active BI 685509 3 mg, 6 mg, and 9 mg).||||||0.0468||||||MMRM estimates were used as input for the MCP-Mod. including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit as well as random effects of patient.|MCP-Mod quadratic model fit|Model assumption: 50 % of the maximum effect is achieved at a dose of 3 mg. 90 % of the maximum effect is achieved at a dose of 6 mg.||||||0.0468
70948660|NCT04750577|141398313|OTHER|MMRM estimates were used as input for the MCP-Mod. including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit as well as random effects of patient.||||||0.0586|||||||MCP-Mod Emax model fit|Model assumption: 80% of the maximum effect is achieved at 6 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of BI 685509 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, quadratic, Emax and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.050). The total daily dose was considered for MCP-Mod analysis (placebo, active BI 685509 3 mg, 6 mg, and 9 mg).||||0.0586
71140462|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|3.29||||0.0307|TWO_SIDED|95.0|1.12|9.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.71|1.12|0.0307
71140463|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|1.29||||0.5921|TWO_SIDED|95.0|0.51|3.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.24|0.51|0.5921
70866269|NCT02478632|141218617|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.013|TWO_SIDED|95.0|0.03|0.27||p value for the difference in adjusted change from Baseline at Week 48 in lumbar spine Z-scores between the DTG+RPV and CAR groups|ANCOVA||The analysis estimated difference between DTG+RPV and CAR in lumbar spine Z-score.|||0.27|0.03|0.013
70866270|NCT02478632|141218620|OTHER||Mean Difference (Final Values)|0.65|||||TWO_SIDED|95.0|-3.51|4.81|||||The analysis refers to INSTI and total hip.|||4.81|-3.51|
70866271|NCT02478632|141218620|OTHER||Mean Difference (Final Values)|1.6|||||TWO_SIDED|95.0|0.39|2.81|||||The analysis refers to NNRTI and total hip.|||2.81|0.39|
70866272|NCT02478632|141218620|OTHER||Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-1.39|3.38|||||this analysis refers to PI and total hip|||3.38|-1.39|
70866273|NCT02478632|141218620|OTHER||Mean Difference (Final Values)|3.85|||||TWO_SIDED|95.0|0.67|7.03|||||this analysis refers to INSTI and lumbar spine.|||7.03|0.67|
70866274|NCT02478632|141218620|OTHER||Mean Difference (Final Values)|1.25|||||TWO_SIDED|95.0|-0.26|2.76|||||this analysis refers to NNRTI and lumbar spine|||2.76|-0.26|
70866275|NCT02478632|141218620|OTHER||Mean Difference (Final Values)|0.38|||||TWO_SIDED|95.0|-3.0|3.77|||||this analysis refers to PI and lumbar spine|||3.77|-3.00|
70866276|NCT02478632|141218621|OTHER||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.26|0.3|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip T-scores by baseline third agent INSTI.|||0.30|-0.26|
70866277|NCT02478632|141218621|OTHER||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|0.03|0.19|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip T-scores by baseline third agent NNRTI.|||0.19|0.03|
70866278|NCT02478632|141218621|OTHER||Mean Difference (Final Values)|0.07|||||TWO_SIDED|95.0|-0.09|0.24|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip T-scores by baseline third agent PI.|||0.24|-0.09|
70866279|NCT02478632|141218621|OTHER||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.25|0.37|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip Z-scores by baseline third agent INSTI.|||0.37|-0.25|
70866280|NCT02478632|141218621|OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|0.02|0.18|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip Z-scores by baseline third agent NNRTI.|||0.18|0.02|
70866281|NCT02478632|141218621|OTHER||Mean Difference (Final Values)|0.04|||||TWO_SIDED|95.0|-0.14|0.21|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip Z-scores by baseline third agent PI.|||0.21|-0.14|
70866282|NCT02478632|141218621|OTHER||Mean Difference (Final Values)|0.36|||||TWO_SIDED|95.0|0.01|0.71|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine T-scores by baseline third agent INSTI.|||0.71|0.01|
70948661|NCT04750577|141398313|OTHER|MMRM estimates were used as input for the MCP-Mod. including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit as well as random effects of patient.||||||0.0659|||||||MCP-Mod Sigmoid emax model fit|Model assumption: 30 % of the maximum effect is achieved at a dose of 3 mg. 90 % of the maximum effect is achieved at a dose of 6 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of BI 685509 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, quadratic, Emax and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.050). The total daily dose was considered for MCP-Mod analysis (placebo, active BI 685509 3 mg, 6 mg, and 9 mg).||||0.0659
71140464|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|2.69||||0.0502|TWO_SIDED|95.0|1.0|7.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.26|1.00|0.0502
70866283|NCT02478632|141218621|OTHER||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-0.03|0.25|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine T-scores by baseline third agent NNRTI.|||0.25|-0.03|
71140465|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|3.31||||0.0224|TWO_SIDED|95.0|1.18|9.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.25|1.18|0.0224
71140466|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|1.18||||0.7225|TWO_SIDED|95.0|0.47|2.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||2.93|0.47|0.7225
71140467|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0762|TWO_SIDED|95.0|0.91|6.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.48|0.91|0.0762
71140468|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|3.51||||0.0252|TWO_SIDED|95.0|1.17|10.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||10.53|1.17|0.0252
71140469|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|2.98||||0.049|TWO_SIDED|95.0|1.0|8.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||8.87|1.00|0.0490
71140470|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|1.97||||0.1773|TWO_SIDED|95.0|0.74|5.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.30|0.74|0.1773
71140471|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0609|TWO_SIDED|95.0|0.96|7.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.16|0.96|0.0609
71140472|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|2.11||||0.1364|TWO_SIDED|95.0|0.79|5.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.61|0.79|0.1364
71140473|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|1.36||||0.5268|TWO_SIDED|95.0|0.53|3.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.51|0.53|0.5268
71140474|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|2.02||||0.1645|TWO_SIDED|95.0|0.75|5.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.46|0.75|0.1645
71140475|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|3.92||||0.0215|TWO_SIDED|95.0|1.22|12.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||12.57|1.22|0.0215
71140476|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|3.04||||0.06|TWO_SIDED|95.0|0.95|9.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||9.69|0.95|0.0600
71140477|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|1.25||||0.6503|TWO_SIDED|95.0|0.47|3.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.32|0.47|0.6503
70866284|NCT02478632|141218621|OTHER||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.3|0.33|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine T-scores by baseline third agent PI.|||0.33|-0.30|
70866285|NCT02478632|141218621|OTHER||Mean Difference (Final Values)|0.38|||||TWO_SIDED|95.0|0.03|0.74|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine Z-scores by baseline third agent INSTI.|||0.74|0.03|
71140478|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0683|TWO_SIDED|95.0|0.93|7.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.88|0.93|0.0683
71140479|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|2.83||||0.0618|TWO_SIDED|95.0|0.95|8.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||8.44|0.95|0.0618
71140480|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|1.34||||0.5621|TWO_SIDED|95.0|0.5|3.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.63|0.50|0.5621
71140481|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|1.92||||0.2182|TWO_SIDED|95.0|0.68|5.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.40|0.68|0.2182
71140482|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|3.11||||0.06|TWO_SIDED|95.0|0.95|10.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||10.15|0.95|0.0600
71140483|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|4.6||||0.029|TWO_SIDED|95.0|1.17|18.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||18.12|1.17|0.0290
71140484|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|1.1||||0.8485|TWO_SIDED|95.0|0.4|3.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.04|0.40|0.8485
71140485|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|2.16||||0.1652|TWO_SIDED|95.0|0.73|6.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.42|0.73|0.1652
71140486|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|1.94||||0.2244|TWO_SIDED|95.0|0.67|5.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.65|0.67|0.2244
71140487|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|1.85||||0.2097|TWO_SIDED|95.0|0.71|4.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.84|0.71|0.2097
71140488|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|1.53||||0.3708|TWO_SIDED|95.0|0.6|3.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.92|0.60|0.3708
71140489|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|2.66||||0.0704|TWO_SIDED|95.0|0.92|7.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||7.66|0.92|0.0704
71140490|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|7.21||||0.004|TWO_SIDED|95.0|1.88|27.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||27.73|1.88|0.0040
71140491|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|2.04||||0.1625|TWO_SIDED|95.0|0.75|5.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.55|0.75|0.1625
71140492|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|4.59||||0.0093|TWO_SIDED|95.0|1.46|14.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||14.50|1.46|0.0093
71140493|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|4.44||||0.0103|TWO_SIDED|95.0|1.42|13.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||13.87|1.42|0.0103
71140494|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|1.89||||0.1965|TWO_SIDED|95.0|0.72|4.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.95|0.72|0.1965
71140495|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|2.69||||0.0549|TWO_SIDED|95.0|0.98|7.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.42|0.98|0.0549
71140496|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|3.01||||0.0503|TWO_SIDED|95.0|1.0|9.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.09|1.00|0.0503
70866286|NCT02478632|141218621|OTHER||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.02|0.26|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine Z-scores by baseline third agent NNRTI.|||0.26|-0.02|
70866287|NCT02478632|141218621|OTHER||Mean Difference (Final Values)|0.04|||||TWO_SIDED|95.0|-0.26|0.34|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine Z-scores by baseline third agent PI.|||0.34|-0.26|
70866288|NCT04622306|141218626|NON_INFERIORITY|The non-inferiority margin for the difference in total clinical failure rates (clinical breakage plus clinical slippage) between the test and control condom is specified in ISO 23409:2011 as 2.5%.|Upper 97.5% CL for difference|2.5||||0.025|ONE_SIDED|97.5||2.5||The p-value was adjusted to 0.025 since two comparisons are being made on the data set.|GEE|||Null Hypothesis: Expected test condom total clinical failure rate - expected control natural rubber latex male condom total clinical failure rate ≥ δ, where δ = 2.5%; Power calculations were conducted according to ISO 29943-1:2017. Target sample sizes were chosen to provide a power of at least 90%.||2.5||0.025
70866289|NCT04622306|141218626|NON_INFERIORITY|The non-inferiority margin for the difference in total failure rates (clinical breakage plus clinical slippage) between the test and control condom is specified on ISO 23409:2011 as 2.5%|Upper 97.5% CLof difference|2.5||||0.025|ONE_SIDED|97.5||2.5||The p-value was adjusted to 0.025 since two comparisons are being made on the data set.|GEE|||Null Hypothesis: Test condom total clinical failure rate - control natural rubber latex male condom total clinical failure rate ≥ δ, where δ = 2.5%; Power calculations were conducted according to ISO 29943-1:2017. Target sample sizes were chosen to provide a power of at least 90%.||2.5||0.025
70866290|NCT04622306|141218626|NON_INFERIORITY|The non-inferiority margin for the difference in total failure rates (clinical breakage plus clinical slippage) between the test and control condom is specified on ISO 23409:2011 as 2.5%|Upper 97.5% CL for difference|2.37||||0.025|ONE_SIDED|97.5||2.5||The p-value was adjusted to 0.025 since two comparisons are being made on the data set|GEE|||The non-inferiority analysis was repeated after removing couples where the male partner had a penis length greater than 170 mm. The polyurethane condom B has a specified nominal length of 170 mm and is not recommended for men with penises longer than the length of the condom.||2.5||0.025
70866291|NCT01601132|141218668|SUPERIORITY_OR_OTHER|||||||0.5663||||||Significant difference defined a priori as p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.5663
70948662|NCT04750577|141398313|OTHER||Mean Difference (Net)|-0.103||||0.3224|TWO_SIDED|95.0|-0.309|0.102|||Mixed-effect Model Repeat Measurement||"Least Squares Mean of 1 mg BI 685509 TID- Least Squares Mean ofPlacebo"|Least Square Means difference and 95% confidence interval were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient.||0.102|-0.309|0.3224
71140497|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|7.03||||0.0046|TWO_SIDED|95.0|1.82|27.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||27.10|1.82|0.0046
71140498|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|2.46||||0.0866|TWO_SIDED|95.0|0.88|6.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.88|0.88|0.0866
70866292|NCT01601132|141218669|SUPERIORITY_OR_OTHER||Ratio (%) (Test/Reference)|105.86|||||TWO_SIDED|90.0|101.77|110.12|||ANOVA||Ratio (theophylline+colchicine/theophylline) of LSMs calculated using the exponentiation of the difference between treatment LSM from the log-transformed Cmax, expressed as a percentage relative to the reference treatment.|Analysis of variance (ANOVA) was performed on the log-transformed Cmax to calculate least squares mean (LSM) for each treatment. The ANOVA model included sequence, treatment, and treatment within a sequence as fixed effects, and participant as a random effect. The criterion for demonstrating a lack of a clinically significant interaction is a 90% CI for the ratio for AUC0-t, (AUC0-∞), and Cmax to be within the 0.80 to 1.25 interval, representing a maximum of 20% difference between treatments.||110.12|101.77|
71140499|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|5.96||||0.0045|TWO_SIDED|95.0|1.74|20.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||20.40|1.74|0.0045
71140500|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|3.59||||0.0207|TWO_SIDED|95.0|1.22|10.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||10.62|1.22|0.0207
71140501|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|1.86||||0.2127|TWO_SIDED|95.0|0.7|4.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.91|0.70|0.2127
71140502|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|2.04||||0.1521|TWO_SIDED|95.0|0.77|5.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.43|0.77|0.1521
71140503|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|5.12||||0.0098|TWO_SIDED|95.0|1.48|17.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||17.70|1.48|0.0098
71140504|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|7.08||||0.0047|TWO_SIDED|95.0|1.82|27.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||27.50|1.82|0.0047
70872207|NCT01727297|141229672|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.58|TWO_SIDED|95.0|0.58|2.6||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having hypertension on a patient's risk of developing AF.|The null hypothesis was that hypertension did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||2.60|0.58|0.58
70866293|NCT01601132|141218670|SUPERIORITY_OR_OTHER||Ratio (%) (Test/Reference)|105.63|||||TWO_SIDED|90.0|101.81|109.59|||ANOVA||Ratio (theophylline+colchicine/theophylline) of LSMs calculated using the exponentiation of the difference between treatment LSM from the log-transformed AUC(0-t)\], expressed as a percentage relative to the reference treatment.|Analysis of variance (ANOVA) was performed on the log-transformed AUC(0-t) to calculate least squares mean (LSM) for each treatment. The ANOVA model included sequence, treatment, and treatment within a sequence as fixed effects, and participant as a random effect. The criterion for demonstrating a lack of a clinically significant interaction is a 90% CI for the ratio for AUC0-t, AUC0-∞, and Cmax to be within the 0.80 to 1.25 interval, representing a maximum of 20% difference between treatments.||109.59|101.81|
70866294|NCT01601132|141218671|SUPERIORITY_OR_OTHER||Ratio (%) (Test/Reference)|106.43|||||TWO_SIDED|90.0|101.1|112.04|||ANOVA||Ratio (theophylline+colchicine/theophylline) of LSMs calculated using the exponentiation of the difference between treatment LSM from the log-transformed AUC(0-∞) , expressed as a percentage relative to the reference treatment.|Analysis of variance (ANOVA) was performed on the log-transformed AUC(0-∞) to calculate least squares mean (LSM) for each treatment. The ANOVA model included sequence, treatment, and treatment within a sequence as fixed effects, and participant as a random effect. The criterion for demonstrating a lack of a clinically significant interaction is a 90% CI for the ratio for AUC0-t, AUC0-∞, and Cmax to be within the 0.80 to 1.25 interval, representing a maximum of 20% difference between treatments.||112.04|101.10|
70866295|NCT01601132|141218672|SUPERIORITY_OR_OTHER||Ratio (%) (Test/Reference)|93.96|||||TWO_SIDED|90.0|89.25|98.92|||ANOVA||Ratio (theophylline+colchicine/theophylline) of LSMs calculated using the exponentiation of the difference between treatment LSM from the log-transformed CL/F, expressed as a percentage relative to the reference treatment.|Analysis of variance (ANOVA) was performed on the log-transformed CL/F to calculate least squares mean (LSM) for each treatment. The ANOVA model included sequence, treatment, and treatment within a sequence as fixed effects, and participant as a random effect. The criterion for demonstrating a lack of a clinically significant interaction is a 90% CI for the ratio for AUC0-t, AUC0-∞, and Cmax to be within the 0.80 to 1.25 interval, representing a maximum of 20% difference between treatments.||98.92|89.25|
70948663|NCT04750577|141398313|OTHER||Mean Difference (Net)|-0.063||||0.5616|TWO_SIDED|95.0|-0.275|0.15|||Mixed-effect Model Repeat Measurement||"Least Squares Mean of 2 mg BI 685509 TID- Least Squares Mean of Placebo"|Least Square Means difference and 95% confidence interval were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient.||0.150|-0.275|0.5616
70948664|NCT04750577|141398313|OTHER||Mean Difference (Net)|-0.251||||0.0183|TWO_SIDED|95.0|-0.459|-0.043|||Mixed-effect Model Repeat Measurement||"Least Squares Mean of 3 mg BI 685509 TID- Least Squares Mean of Placebo"|Least Square Means difference and 95% confidence interval were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient.||-0.043|-0.459|0.0183
71140505|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|2.0||||0.1817|TWO_SIDED|95.0|0.72|5.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.51|0.72|0.1817
71140506|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|6.09||||0.0042|TWO_SIDED|95.0|1.77|20.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||20.95|1.77|0.0042
71140507|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|6.09||||0.0039|TWO_SIDED|95.0|1.78|20.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||20.74|1.78|0.0039
71140508|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|1.23||||0.7025|TWO_SIDED|95.0|0.42|3.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.57|0.42|0.7025
71140509|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|1.03||||0.9599|TWO_SIDED|95.0|0.36|2.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||2.97|0.36|0.9599
71140510|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9671|TWO_SIDED|95.0|0.34|3.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.10|0.34|0.9671
71140511|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|1.26||||0.681|TWO_SIDED|95.0|0.42|3.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.83|0.42|0.6810
71140512|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|1.31||||0.6346|TWO_SIDED|95.0|0.43|4.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||4.04|0.43|0.6346
71140513|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|1.16||||0.7929|TWO_SIDED|95.0|0.38|3.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.57|0.38|0.7929
71140514|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|1.13||||0.8188|TWO_SIDED|95.0|0.39|3.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.28|0.39|0.8188
71140515|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|0.88||||0.8226|TWO_SIDED|95.0|0.3|2.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.60|0.30|0.8226
71140516|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|0.94||||0.9088|TWO_SIDED|95.0|0.32|2.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.72|0.32|0.9088
71140517|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|0.75||||0.6189|TWO_SIDED|95.0|0.24|2.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.35|0.24|0.6189
71140518|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|1.3||||0.6463|TWO_SIDED|95.0|0.42|4.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.03|0.42|0.6463
70866296|NCT01601132|141218673|SUPERIORITY_OR_OTHER||Ratio (%) (Test/Reference)|98.59|||||TWO_SIDED|90.0|90.97|106.85|||ANOVA||Ratio (theophylline+colchicine/theophylline) of LSMs calculated using the exponentiation of the difference between treatment LSM from the log-transformed Vd/F, expressed as a percentage relative to the reference treatment.|Analysis of variance (ANOVA) was performed on the log-transformed Vd/F to calculate least squares mean (LSM) for each treatment. The ANOVA model included sequence, treatment, and treatment within a sequence as fixed effects, and participant as a random effect. The criterion for demonstrating a lack of a clinically significant interaction is a 90% CI for the ratio for AUC0-t, AUC0-∞, and Cmax to be within the 0.80 to 1.25 interval, representing a maximum of 20% difference between treatments.||106.85|90.97|
70866297|NCT02110238|141218674|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A VAS (0-100 mm) WOMAC Pain subscale score CFB; an equal n t-test for non-inferiority of means; a non-inferiority margin of -8 mm; change standard deviation of 26 mm; two-sided alpha=0.05; 80% power; an expected mean difference of 0, and a drop-out plus important deviation percentage of approximately 20% were used to establish study sample size.|Least square mean difference|-3.3|||||TWO_SIDED|95.0|-6.77|0.17|||||"A MERM regression model was fit to the change from baseline at weeks 3, 6, and 12. The over weeks 3, 6, and 12 single point estimate least square mean change was calculated for both arms, the difference and its 95% confidence interval calculated."|||0.17|-6.77|
70866298|NCT01419626|141218686|SUPERIORITY||Difference in LS mean|-0.461|||<|0.001|TWO_SIDED|95.0|-0.581|-0.341|||ANCOVA|||Statistical analysis at Week 4||-0.341|-0.581|<0.001
70866299|NCT01419626|141218686|SUPERIORITY||Difference in LS mean|-0.669|||<|0.001|TWO_SIDED|95.0|-0.789|-0.549|||ANCOVA|||Statistical analysis at Week 4||-0.549|-0.789|<0.001
70948665|NCT04750577|141398314|OTHER||Mean Difference (Net)|-0.211||||0.0396|TWO_SIDED|0.95|-0.413|-0.01|||Mixed Models Analysis||"Least Squares Mean of 1 mg BI 685509 TID- Least Squares Mean of Placebo"|Least Square Means difference and 95% confidence interval were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient.||-0.010|-0.413|0.0396
70948666|NCT04750577|141398314|OTHER||Mean Difference (Net)|-0.12||||0.2568|TWO_SIDED|0.95|-0.327|0.088|||Mixed Models Analysis||"Least Squares Mean of 2 mg BI 685509 TID- Least Squares Mean of Placebo"|Least Square Means difference and 95% confidence interval were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient.||0.088|-0.327|0.2568
71140519|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|1.47||||0.506|TWO_SIDED|95.0|0.47|4.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.54|0.47|0.5060
71140520|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|1.67||||0.3842|TWO_SIDED|95.0|0.53|5.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.31|0.53|0.3842
70866300|NCT01419626|141218686|SUPERIORITY|Statistical analysis at Week 4|Difference in LS mean|-0.208|||<|0.001|TWO_SIDED|95.0|-0.326|-0.09|||ANCOVA|||||-0.090|-0.326|<0.001
70866301|NCT01419626|141218687|SUPERIORITY||Difference in LS mean|-0.494|||<|0.001|TWO_SIDED|95.0|-0.625|-0.363|||ANCOVA|||Statistical analysis at Week 4||-0.363|-0.625|<0.001
70866302|NCT01419626|141218687|SUPERIORITY||Difference in LS mean|-0.697|||<|0.001|TWO_SIDED|95.0|-0.828|-0.567|||ANCOVA|||Statistical analysis at Week 4||-0.567|-0.828|<0.001
71140521|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|1.44||||0.5021|TWO_SIDED|95.0|0.49|4.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.23|0.49|0.5021
71140522|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|0.42||||0.1349|TWO_SIDED|95.0|0.14|1.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.31|0.14|0.1349
71140523|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|0.57||||0.3191|TWO_SIDED|95.0|0.19|1.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.71|0.19|0.3191
71140524|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|0.3||||0.0623|TWO_SIDED|95.0|0.09|1.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.06|0.09|0.0623
70866303|NCT01419626|141218687|SUPERIORITY||Difference in LS mean|-0.203||||0.002||95.0|-0.333|-0.074|||ANCOVA|||Statistical analysis at Week 4||-0.074|-0.333|0.002
70866304|NCT01419626|141218688|SUPERIORITY||Difference in LS mean|-0.04|||<|0.001|TWO_SIDED|95.0|-0.059|-0.021|||ANCOVA|||Statistical analysis at Week 2||-0.021|-0.059|<0.001
70866305|NCT01419626|141218688|SUPERIORITY||Difference in LS mean|-0.044|||<|0.001||95.0|-0.064|-0.025|||ANCOVA|||Statistical analysis at Week 2||-0.025|-0.064|<0.001
70866306|NCT01419626|141218688|SUPERIORITY||Difference in LS mean|-0.004||||0.671|TWO_SIDED|95.0|-0.023|0.015|||ANCOVA|||Statistical analysis at Week 2||0.015|-0.023|0.671
70866307|NCT01419626|141218688|SUPERIORITY||Difference in LS mean|-0.091|||<|0.001|TWO_SIDED|95.0|-0.121|-0.061|||ANCOVA|||Statistical analysis at Week 4||-0.061|-0.121|<0.001
70866308|NCT01419626|141218688|SUPERIORITY||Difference in LS mean|-0.144|||<|0.001|TWO_SIDED|95.0|-0.175|-0.114|||ANCOVA|||Statistical analysis at Week 4||-0.114|-0.175|<0.001
70866309|NCT01419626|141218688|SUPERIORITY||Difference in LS mean|-0.053|||<|0.001|TWO_SIDED|95.0|-0.083|-0.023|||ANCOVA|||Statistical analysis at Week 4||-0.023|-0.083|<0.001
70948667|NCT04750577|141398314|OTHER||Mean Difference (Net)|-0.357||||0.0006|TWO_SIDED|0.95|-0.56|-0.154|||Mixed Models Analysis||"Least Squares Mean of 3 mg BI 685509 TID- Least Squares Mean of Placebo"|Least Square Means difference and 95% confidence interval were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient.||-0.154|-0.560|0.0006
70948668|NCT04750577|141398315|OTHER||Odds Ratio (OR)|2.25||||0.0519|TWO_SIDED|95.0|0.99|5.1|||Regression, Logistic||Odds Ratio was calculated as BI 685509/ Placebo.|Treatment, sodium-Glucose co-Transporter-2 Inhibitor (SGLT2i) use at baseline, and type of diabetes were used as covariates in the logistic regression model.||5.10|0.99|0.0519
70948669|NCT04750577|141398315|OTHER||Odds Ratio (OR)|1.43||||0.4159|TWO_SIDED|95.0|0.61|3.36|||Regression, Logistic||Odds Ratio was calculated as BI 685509/ Placebo.|Treatment, sodium-Glucose co-Transporter-2 Inhibitor (SGLT2i) use at baseline, and type of diabetes were used as covariates in the logistic regression model.||3.36|0.61|0.4159
70948670|NCT04750577|141398315|OTHER||Odds Ratio (OR)|2.9||||0.0106|TWO_SIDED|95.0|1.28|6.55|||Regression, Logistic||Odds Ratio was calculated as BI 685509/ Placebo.|Treatment, sodium-Glucose co-Transporter-2 Inhibitor (SGLT2i) use at baseline, and type of diabetes were used as covariates in the logistic regression model.||6.55|1.28|0.0106
70948671|NCT04750577|141398316|OTHER||Odds Ratio (OR)|2.79||||0.0176|TWO_SIDED|95.0|1.2|6.53|||Regression, Logistic||Odds Ratio was calculated as BI 685509/ Placebo.|Treatment, sodium-Glucose co-Transporter-2 Inhibitor (SGLT2i) use at baseline, and type of diabetes were used as covariates in the logistic regression model.||6.53|1.20|0.0176
70948672|NCT04750577|141398316|OTHER||Odds Ratio (OR)|1.32||||0.5467|TWO_SIDED|95.0|0.53|3.29|||Regression, Logistic||Odds Ratio was calculated as BI 685509/ Placebo.|Treatment, sodium-Glucose co-Transporter-2 Inhibitor (SGLT2i) use at baseline, and type of diabetes were used as covariates in the logistic regression model.||3.29|0.53|0.5467
70948673|NCT04750577|141398316|OTHER||Odds Ratio (OR)|4.46||||0.0005|TWO_SIDED|95.0|1.91|10.39|||Regression, Logistic||Odds Ratio was calculated as BI 685509/ Placebo.|Treatment, sodium-Glucose co-Transporter-2 Inhibitor (SGLT2i) use at baseline, and type of diabetes were used as covariates in the logistic regression model.||10.39|1.91|0.0005
70948674|NCT02035696|141398355|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|0.99|||||TWO_SIDED|95.0|0.65|1.52||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 1||1.52|0.65|
70948675|NCT02035696|141398355|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 50|2.11|||||TWO_SIDED|95.0|1.5|2.98||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 50||2.98|1.5|
70948676|NCT02035696|141398355|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 1|0.68|||||TWO_SIDED|95.0|0.43|1.06||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 1||1.06|0.43|
71140525|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|0.47||||0.1958|TWO_SIDED|95.0|0.15|1.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.48|0.15|0.1958
71140526|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|0.62||||0.4353|TWO_SIDED|95.0|0.19|2.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.05|0.19|0.4353
71140527|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9729|TWO_SIDED|95.0|0.31|3.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.31|0.31|0.9729
71140528|NCT03192176|141778525|SUPERIORITY||Odds Ratio (OR)|0.64||||0.4211|TWO_SIDED|95.0|0.22|1.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.89|0.22|0.4211
70866310|NCT01419626|141218689|SUPERIORITY||Difference in LS mean|-0.09|||<|0.001|TWO_SIDED|95.0|-0.115|-0.065|||ANCOVA|||Statistical analysis at Week 2||-0.065|-0.115|<0.001
70866311|NCT01419626|141218689|SUPERIORITY||Difference in LS mean|-0.164|||<|0.001|TWO_SIDED|95.0|-0.189|-0.138|||ANCOVA|||Statistical analysis at Week 2||-0.138|-0.189|<0.001
70866312|NCT01419626|141218689|SUPERIORITY||Difference in LS mean|-0.073|||<|0.001|TWO_SIDED|95.0|-0.099|-0.048|||ANCOVA|||Statistical analysis at Week 2||-0.048|-0.099|<0.001
70866313|NCT01419626|141218689|SUPERIORITY||Difference in LS mean|-0.15|||<|0.001|TWO_SIDED|95.0|-0.18|-0.12|||ANCOVA|||Statistical analysis at Week 4||-0.120|-0.180|<0.001
70948677|NCT02035696|141398355|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 50|0.71|||||TWO_SIDED|95.0|0.58|0.87||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 50||0.87|0.58|
70948678|NCT02035696|141398355|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|1.0|||||TWO_SIDED|95.0|0.92|1.08||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 1||1.08|0.92|
70948679|NCT02035696|141398355|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 50|0.78|||||TWO_SIDED|95.0|0.6|1.01||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 50||1.01|0.6|
70948680|NCT02035696|141398355|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|1.27|||||TWO_SIDED|95.0|0.83|1.96||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 1||1.96|0.83|
70948681|NCT02035696|141398355|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 50|1.6|||||TWO_SIDED|95.0|1.13|2.28||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 50||2.28|1.13|
70948682|NCT02035696|141398355|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|0.52|||||TWO_SIDED|95.0|0.33|0.81||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 1||0.81|0.33|
70948683|NCT02035696|141398355|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 50|0.64|||||TWO_SIDED|95.0|0.52|0.78||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 50||0.78|0.52|
70948684|NCT02035696|141398355|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 1|0.96|||||TWO_SIDED|95.0|0.89|1.04||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 1||1.04|0.89|
70948685|NCT02035696|141398355|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 50|0.64|||||TWO_SIDED|95.0|0.49|0.84||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 50||0.84|0.49|
71140529|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|3.05||||0.1938|TWO_SIDED|95.0|0.57|16.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.35|0.57|0.1938
70948686|NCT02035696|141398355|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|1.02|||||TWO_SIDED|95.0|0.66|1.58||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 1||1.58|0.66|
70948687|NCT02035696|141398355|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 50|1.62|||||TWO_SIDED|95.0|1.14|2.3||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 50||2.3|1.14|
71140530|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|6.97||||0.0162|TWO_SIDED|95.0|1.43|33.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||33.91|1.43|0.0162
71140531|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|14.37||||0.0008|TWO_SIDED|95.0|3.04|67.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||67.96|3.04|0.0008
71140532|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|16.02||||0.0005|TWO_SIDED|95.0|3.39|75.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||75.68|3.39|0.0005
71140533|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|3.02||||0.1971|TWO_SIDED|95.0|0.56|16.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.17|0.56|0.1971
71140534|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|4.31||||0.0811|TWO_SIDED|95.0|0.83|22.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||22.27|0.83|0.0811
71140535|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|11.44||||0.0021|TWO_SIDED|95.0|2.43|53.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||53.94|2.43|0.0021
71140536|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|2.11||||0.137|TWO_SIDED|95.0|0.79|5.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.64|0.79|0.1370
71140537|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|3.2||||0.0181|TWO_SIDED|95.0|1.22|8.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.40|1.22|0.0181
70866314|NCT01419626|141218689|SUPERIORITY||Difference in LS mean|-0.257|||<|0.001|TWO_SIDED|95.0|-0.287|-0.226|||ANCOVA|||Statistical analysis at Week 4||-0.226|-0.287|<0.001
70866315|NCT01419626|141218689|SUPERIORITY||Difference in LS mean|-0.107|||<|0.001|TWO_SIDED|95.0|-0.137|-0.077|||ANCOVA|||Statistical analysis at Week 4||-0.077|-0.137|<0.001
70866316|NCT01419626|141218690|SUPERIORITY||Difference in LS mean|-0.362|||<|0.001|TWO_SIDED|95.0|-0.465|-0.259|||ANCOVA|||Statistical analysis at Week 2||-0.259|-0.465|<0.001
70866317|NCT01419626|141218690|SUPERIORITY||Difference in LS mean|-0.534|||<|0.001|TWO_SIDED|95.0|-0.637|-0.431|||ANCOVA|||Statistical analysis at Week 2||-0.431|-0.637|<0.001
70866318|NCT01419626|141218690|SUPERIORITY||Difference in LS mean|-0.171||||0.001|TWO_SIDED|95.0|-0.273|-0.069|||ANCOVA|||Statistical analysis at Week 2||-0.069|-0.273|0.001
70866319|NCT01419626|141218691|SUPERIORITY||Difference in LS mean|-0.401|||<|0.001|TWO_SIDED|95.0|-0.51|-0.292|||ANCOVA|||Statistical analysis at Week 2||-0.292|-0.510|<0.001
70866320|NCT01419626|141218691|SUPERIORITY||Difference in LS mean|-0.558|||<|0.001|TWO_SIDED|95.0|-0.667|-0.449|||ANCOVA|||Statistical analysis at Week 2||-0.449|-0.667|<0.001
70866321|NCT01419626|141218691|SUPERIORITY||Difference in LS mean|-0.157|||<|0.001|TWO_SIDED|95.0|-0.265|-0.049|||ANCOVA|||Statistical analysis at Week 2||-0.049|-0.265|<0.001
70866322|NCT01419626|141218692|SUPERIORITY||Difference in LS mean|-0.03|||<|0.001|TWO_SIDED|95.0|-0.046|-0.014|||ANCOVA|||Statistical analysis at Week 2||-0.014|-0.046|<0.001
70866323|NCT01419626|141218692|SUPERIORITY||Difference in LS mean|-0.039|||<|0.001|TWO_SIDED|95.0|-0.055|-0.023|||ANCOVA|||Statistical analysis at Week 2||-0.023|-0.055|<0.001
70866324|NCT01419626|141218692|SUPERIORITY||Difference in LS mean|-0.009||||0.294|TWO_SIDED|95.0|-0.025|0.007|||ANCOVA|||Statistical analysis at Week 2||0.007|-0.025|0.294
70866325|NCT01419626|141218692|SUPERIORITY||Difference in LS mean|-0.019||||0.02|TWO_SIDED|95.0|-0.035|-0.003|||ANCOVA|||Statistical analysis at Week 4||-0.003|-0.035|0.020
70866326|NCT01419626|141218692|SUPERIORITY||Difference in LS mean|-0.034|||<|0.001|TWO_SIDED|95.0|-0.05|-0.018|||ANCOVA|||Statistical analysis at Week 4||-0.018|-0.050|<0.001
70866327|NCT01419626|141218692|SUPERIORITY||Difference in LS mean|-0.015||||0.071|TWO_SIDED|95.0|-0.031|0.001|||ANCOVA|||Statistical analysis at Week 4||0.001|-0.031|0.071
70866328|NCT01419626|141218693|SUPERIORITY||Difference in LS mean|-0.067|||<|0.001||95.0|-0.083|-0.05|||ANCOVA|||Statistical analysis at Week 2||-0.050|-0.083|<0.001
70866329|NCT01419626|141218693|SUPERIORITY||Difference in LS mean|-0.083|||<|0.001|TWO_SIDED|95.0|-0.099|-0.066|||ANCOVA|||Statistical analysis at Week 2||-0.066|-0.099|<0.001
70866330|NCT01419626|141218693|SUPERIORITY||Difference in LS mean|-0.016||||0.057|TWO_SIDED|95.0|-0.032|0.0|||ANCOVA|||Statistical analysis at Week 2||0.000|-0.032|0.057
70866331|NCT01419626|141218693|SUPERIORITY||Difference in LS mean|-0.077|||<|0.001|TWO_SIDED|95.0|-0.095|-0.059|||ANCOVA|||Statistical analysis at Week 4||-0.059|-0.095|<0.001
70866332|NCT01419626|141218693|SUPERIORITY||Difference in LS mean|-0.101|||<|0.001|TWO_SIDED|95.0|-0.12|-0.083|||ANCOVA|||Statistical analysis at Week 4||-0.083|-0.120|<0.001
70866333|NCT01419626|141218693|SUPERIORITY||Difference in LS mean|-0.024||||0.009|TWO_SIDED|95.0|-0.042|-0.006|||ANCOVA|||Statistical analysis at Week 4||-0.006|-0.042|0.009
70866334|NCT01145625|141218699|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was claimed if the lower limit of the 95% Confidence Interval (CI) was greater than -6.565.|Mean Difference (Final Values)|-0.3||||0.917|TWO_SIDED|95.0|-6.0|5.4|||ANCOVA|P-Value and confidence interval are from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.||Statistical analysis is for the change from baseline to week 24 data.||5.4|-6.0|0.9170
70866335|NCT01145625|141218700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|||<|0.4158|TWO_SIDED|95.0|-3.4|8.2|||ANCOVA|P-Value and confidence interval are from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.||Statistical analysis is for the change from baseline to week 12 data.||8.2|-3.4|<0.4158
70866336|NCT01145625|141218701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.598|TWO_SIDED|95.0|-7.1|4.1|||ANCOVA|P-value and confidence interval are from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.||Statistical analysis is for the change from baseline to week 52 data.||4.1|-7.1|0.5980
70866337|NCT03080454|141218702|EQUIVALENCE|Statistical analysis for mean percent change from baseline in area under the curve for the resistance torque measure across 2 conditions (anodal vs. sham Doublestim) and at 2 timepoints (final session at day 5 and 1 week FU). Null hypothesis is that there was no difference in mean percent change in area under the curve between anodal and sham Doublestim conditions. A significance level of 0.05 was used (two-sided).||||||0.004||||||A 2x2 repeated measures ANOVA was performed with condition (mean percent change in anodal vs. sham condition) and time (final session at day 5 and 1 week FU in each condition) as factors. A significance level of 0.05 was used (two-sided).|ANOVA|||||||0.004
70866338|NCT03080454|141218703|EQUIVALENCE|Statistical analysis for mean Tardieu Scale Score summed across 11 joints of the upper extremity in 2 conditions (anodal vs. sham Doublestim) and at 2 timepoints (final session at day 5 and 1 week FU). Null hypothesis is that there was no difference in mean change between anodal and sham Doubleestim conditions. A significance level of 0.05 was used (two-sided).||||||0.003||||||A 2x2 repeated measures ANOVA was performed with condition (mean score in anodal vs. sham condition) and time (final session at day 5 and 1 week FU in each condition) as factors. A significance level of 0.05 was used (two-sided).|ANOVA|||||||0.003
70866339|NCT00216476|141218704|SUPERIORITY_OR_OTHER||||||<|0.0001||||||threshold for significance: 0.05 (2-sided)|Log Rank|||Null hypothesis was that there is no difference in treatment effect between risperidone LAI and quetiapine by mean relapse free period; given a estimated relapse rate of 30% for risperidone LAI and 42% for quetiapine, with 80% power and 5% 2-tailed significance level, 251 subjects were needed per treatment arm. To adjust for an estimated 20% discontinuations for reasons other than relapse, 628 subjects in total were needed. Actual relapse rates were 17% (risperidone LAI) and 31% (quetiapine).||||<0.0001
70866340|NCT00216476|141218706|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon (Mann-Whitney)|||Between-group comparison of the change from baseline to endpoint in total PANSS score. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.0001
70866341|NCT00216476|141218706|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in total PANSS score. The endpoint of the study was based on the LOCF principle.||||<0.0001
70866342|NCT00216476|141218706|SUPERIORITY_OR_OTHER|||||||0.1026|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in total PANSS score. The endpoint of the study was based on the LOCF principle.||||0.1026
70948688|NCT02035696|141398355|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|0.74|||||TWO_SIDED|95.0|0.47|1.17||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 1||1.17|0.47|
70948689|NCT02035696|141398355|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 50|0.46|||||TWO_SIDED|95.0|0.38|0.57||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 50||0.57|0.38|
70948690|NCT02035696|141398355|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|0.94|||||TWO_SIDED|95.0|0.87|1.02||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 1||1.02|0.87|
70948691|NCT02035696|141398355|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 50|0.57|||||TWO_SIDED|95.0|0.44|0.75||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 50||0.75|0.44|
70948692|NCT02035696|141398356|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|10.0|||||TWO_SIDED|95.0|0.0|18.9||||||Non-inferiority of immune responses of TIVc-High Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H1N1||18.9|0|
70948693|NCT02035696|141398356|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|2.0|||||TWO_SIDED|95.0|-4.0|8.0||||||Non-inferiority of immune responses of TIVc-High Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H3N2||8|-4|
70948694|NCT02035696|141398356|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group differences|-11.0|||||TWO_SIDED|95.0|-21.1|-1.5||||||Non-inferiority of immune responses of TIVc-High Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain B||-1.5|-21.1|
70948695|NCT02035696|141398356|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|7.0|||||TWO_SIDED|95.0|-2.5|16.8||||||Non-inferiority of immune responses of TIVc-Full Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H1N1||16.8|-2.5|
70948696|NCT02035696|141398356|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group differences|-3.0|||||TWO_SIDED|95.0|-9.5|4.1||||||Non-inferiority of immune responses of TIVc-Full Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H3N2||4.1|-9.5|
71140538|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|6.43||||0.0002|TWO_SIDED|95.0|2.43|17.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||17.05|2.43|0.0002
71140539|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|6.08||||0.0003|TWO_SIDED|95.0|2.26|16.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||16.31|2.26|0.0003
71140540|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|1.65||||0.3241|TWO_SIDED|95.0|0.61|4.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||4.49|0.61|0.3241
71140541|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|1.85||||0.2249|TWO_SIDED|95.0|0.68|5.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.03|0.68|0.2249
71140542|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|3.53||||0.0096|TWO_SIDED|95.0|1.36|9.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||9.18|1.36|0.0096
70866343|NCT00216476|141218707|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon (Mann-Whitney)|||Between-group comparison of the change from baseline to endpoint in CGI-S score. The endpoint of the study was based on the LOCF principle.||||<0.0001
70866344|NCT00216476|141218707|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in CGI-S score. The endpoint of the study was based on the LOCF principle.||||<0.0001
70866345|NCT00216476|141218707|SUPERIORITY_OR_OTHER|||||||0.0446|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in CGI-S score. The endpoint of the study was based on the LOCF principle.||||0.0446
70866346|NCT00216476|141218708|SUPERIORITY_OR_OTHER|||||||0.0941|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon (Mann-Whitney)|||Between-group comparison of the change from baseline to endpoint in PCS score. The endpoint of the study was based on the LOCF principle.||||0.0941
70948697|NCT02035696|141398356|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|-11.0|||||TWO_SIDED|95.0|-20.5|-1.0||||||Non-inferiority of immune responses of TIVc-Full Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain B||-1|-20.5|
70948698|NCT02035696|141398356|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|6.0|||||TWO_SIDED|95.0|-4.2|15.4||||||Non-inferiority of immune responses of TIVc- Half Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H1N1||15.4|-4.2|
70948699|NCT02035696|141398356|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|-6.0|||||TWO_SIDED|95.0|-13.4|1.3||||||Non-inferiority of immune responses of TIVc- Half Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H3N2||1.3|-13.4|
70948700|NCT02035696|141398356|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|-18.0|||||TWO_SIDED|95.0|-27.8|-7.2||||||Non-inferiority of immune responses of TIVc- Half Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain B||-7.2|-27.8|
70948701|NCT02035696|141398357|SUPERIORITY_OR_OTHER||Desirability Index Score|0.0|||||TWO_SIDED||||||||Desirability Score: If this difference is negative, then it is defined as non-desirable (D equal to 0), while if the difference is positive, then D will equal to the relative reduction calculated in the following way: D = (TIVe - TIVc Dose )/TIVe.|||||
70948702|NCT02035696|141398357|SUPERIORITY_OR_OTHER||Desirability Index Score|0.0|||||TWO_SIDED||||||||Desirability Score: If this difference is negative, then it is defined as non-desirable (D equal to 0), while if the difference is positive, then D will equal to the relative reduction calculated in the following way: D = (TIVe - TIVc Dose )/TIVe.|||||
71140543|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|2.35||||0.0768|TWO_SIDED|95.0|0.91|6.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.05|0.91|0.0768
70948703|NCT02035696|141398357|SUPERIORITY_OR_OTHER||Desirability Index Score|0.0|||||TWO_SIDED||||||||Desirability Score: If this difference is negative, then it is defined as non-desirable (D equal to 0), while if the difference is positive, then D will equal to the relative reduction calculated in the following way: D = (TIVe - TIVc Dose )/TIVe.|||||
70948704|NCT01867047|141398377|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||Statistical analysis for intraoperative mild hypotension||||0.140
70948705|NCT01867047|141398377|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Statistical analysis for postoperative mild hypotension||||1.000
70948706|NCT01867047|141398379|SUPERIORITY|||||||0.102|||||||t-test, 2 sided|||Analysis for number of participants given vasopressors intraoperatively||||0.102
70948707|NCT01867047|141398382|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.700
70948708|NCT01867047|141398383|SUPERIORITY|||||||0.702|||||||t-test, 2 sided|||||||0.702
70948709|NCT00349466|141398384|SUPERIORITY|||||||0.027|||||||ANCOVA|||||||0.027
70948710|NCT00349466|141398385|SUPERIORITY|||||||0.083|||||||ANCOVA|||||||0.083
70948711|NCT00349466|141398386|SUPERIORITY_OR_OTHER_LEGACY|||||||0.028|TWO_SIDED|95.0|||||Fisher Exact|||||||0.028
70948712|NCT00349466|141398387|SUPERIORITY|||||||0.655|||||||Fisher Exact|||||||0.655
70948713|NCT00349466|141398388|SUPERIORITY|||||||0.387|||||||ANCOVA|||||||0.387
71140544|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|2.91||||0.00251|TWO_SIDED|95.0|1.14|7.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.39|1.14|0.00251
71140545|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|5.99||||0.0002|TWO_SIDED|95.0|2.3|15.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||15.57|2.30|0.0002
70948714|NCT00349466|141398389|SUPERIORITY|||||||0.203|||||||Wilcoxon (Mann-Whitney)|||||||0.203
70948715|NCT00349466|141398390|SUPERIORITY|||||||0.807|||||||ANCOVA|||||||.807
70948716|NCT01536587|141398391|SUPERIORITY_OR_OTHER|||||||0.5062||95.0|||||paired t-Test, 2-sided|||||||0.5062
70948717|NCT01515943|141398433|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0||||0.56|TWO_SIDED|97.5|-19.0|11.0||Linear contrasts performed with a type I error rate of 2.5% based on a Bonferroni adjustment (overall type I error rate of 5% for 2 pairwise treatment group comparisons).|Biniomial regression|Adjusted for baseline covariates of CISS score, mean NPC break and mean PFV blur. Linear contrasts performed with Bonferroni adjustment (alpha=0.025)|Negative values for the treatment group difference favor the HB-PU group. Results of the treatment group comparison are adjusted for baseline covariates of CISS, mean NPC break and mean PFV blur.|The primary outcome was success at 12 weeks. The sample size was computed to have 90% power to detect a treatment group difference between the HB-C versus HB-PU groups, assuming true population success percentages of 30% and 15% for the HB-C and HB-PU groups, respectively, with a type I error rate of 2.5%. The treatment group comparison was adjusted for baseline covariates of CISS score (\<28 points vs ≥28 points), mean NPC break (\<10 cm vs ≥10 cm) and mean PFV blur (≥15 pd vs \<15 pd).||11|-19|0.56
71140546|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|7.29|||<|0.0001|TWO_SIDED|95.0|2.7|19.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||19.71|2.70|<0.0001
70866347|NCT00216476|141218708|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in PCS score. The endpoint of the study was based on the LOCF principle.||||<0.0001
70866348|NCT00216476|141218708|SUPERIORITY_OR_OTHER|||||||0.1146|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in PCS score. The endpoint of the study was based on the LOCF principle.||||0.1146
70866349|NCT00216476|141218708|SUPERIORITY_OR_OTHER|||||||0.5589|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon (Mann-Whitney)|||Between-group comparison of the change from baseline to endpoint in MCS score. The endpoint of the study was based on the LOCF principle.||||0.5589
71140547|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|2.14||||0.1144|TWO_SIDED|95.0|0.83|5.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||5.50|0.83|0.1144
71140548|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|2.06||||0.1341|TWO_SIDED|95.0|0.8|5.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||5.30|0.80|0.1341
71140549|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|4.43||||0.0017|TWO_SIDED|95.0|1.75|11.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||11.22|1.75|0.0017
71140550|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|2.06||||0.1488|TWO_SIDED|95.0|0.77|5.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.50|0.77|0.1488
71140551|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|3.99||||0.0043|TWO_SIDED|95.0|1.54|10.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.30|1.54|0.0043
71140552|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|5.53||||0.0005|TWO_SIDED|95.0|2.1|14.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||14.57|2.10|0.0005
71140553|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|14.54|||<|0.0001|TWO_SIDED|95.0|4.85|43.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||43.58|4.85|<0.0001
71140554|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|2.96||||0.0262|TWO_SIDED|95.0|1.14|7.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.68|1.14|0.0262
71140555|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|5.07||||0.0009|TWO_SIDED|95.0|1.95|13.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||13.19|1.95|0.0009
71140556|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|5.33||||0.0006|TWO_SIDED|95.0|2.06|13.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||13.80|2.06|0.0006
71140557|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|1.52||||0.3673|TWO_SIDED|95.0|0.61|3.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||3.75|0.61|0.3673
71140558|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|2.02||||0.1207|TWO_SIDED|95.0|0.83|4.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.91|0.83|0.1207
71140559|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|5.01||||0.0011|TWO_SIDED|95.0|1.9|13.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||13.21|1.90|0.0011
70866350|NCT00216476|141218708|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in MCS score. The endpoint of the study was based on the LOCF principle.||||<0.0001
70866351|NCT00216476|141218708|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in MCS score. The endpoint of the study was based on the LOCF principle.||||<0.0001
70866352|NCT00696800|141218728|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Treatment groups were formally compared with a generalized linear model for the ongoing pregnancy rate which included factors for treatment group, age at randomization, and region. A pre-defined non-inferiority margin of 8% was applied.|Risk Difference (RD)|1.1|||||TWO_SIDED|95.0|-3.8|5.9||||||||5.9|-3.8|
70866353|NCT00696800|141218729|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence margins of -3 and +5 were applied for the difference in number of oocytes. If the 95% confidence interval of the difference exceeded -3 or +5 oocytes, then Corifollitropin Alfa treatment was not considered equivalent to the reference treatment (recFSH).|Mean Difference (Final Values)|1.2||||0.001|TWO_SIDED|95.0|0.5|1.9||Treatment groups were formally compared including covariates treatment group, age and center.|ANOVA|||||1.9|0.5|0.001
70866354|NCT03779711|141218755|SUPERIORITY|||||||0.8095|||||||ANCOVA|adjusted for baseline FAC||Analysis of covariance (ANCOVA), adjusted for baseline FAC, is used to assess change in FAC from baseline to 3-months post-surgery.||||0.8095
70866355|NCT03779711|141218756|SUPERIORITY|||||||0.3029|||||||ANCOVA|Adjusted for baseline circumferential strain||Analysis of covariance (ANCOVA), adjusted for baseline circumferential strain, is used to assess change in circumferential strain from baseline to 3-months post-surgery.||||0.3029
70866356|NCT03779711|141218757|SUPERIORITY|||||||0.0323|||||||ANCOVA|Adjusted for baseline longitudinal strain||Analysis of covariance (ANCOVA), adjusted for baseline longitudinal strain, is used to assess change in longitudinal strain from baseline to 3-months post-surgery.||||0.0323
71140560|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|9.19|||<|0.0001|TWO_SIDED|95.0|3.08|27.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||27.38|3.08|<0.0001
71140561|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|2.38||||0.0594|TWO_SIDED|95.0|0.97|5.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.86|0.97|0.0594
70866357|NCT03779711|141218758|SUPERIORITY|||||||0.6765|||||||ANCOVA|Adjusted for baseline FAC.||Analysis of covariance (ANCOVA), adjusted for baseline FAC, is used to assess change in FAC from baseline to 12-months post-surgery.||||0.6765
70866358|NCT03779711|141218759|SUPERIORITY|||||||0.3456|||||||ANCOVA|Adjusted for baseline FAC||Analysis of covariance (ANCOVA), adjusted for baseline FAC, is used to assess change in FAC from baseline to discharge.||||0.3456
70866359|NCT03779711|141218760|SUPERIORITY|||||||0.776|||||||Kruskal-Wallis|||Kruskal-Wallis test comparing number of days in hospital post stage-II surgery.||||0.7760
70948718|NCT01515943|141398434|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.0||||0.52|TWO_SIDED|97.5|-12.0|22.0||Linear contrasts performed with a type I error rate of 2.5% based on a Bonferroni adjustment (overall type I error rate of 5% for 2 pairwise treatment group comparisons).|Binomial regression|Adjusted for baseline covariates of CISS score, mean NPC break and mean PFV blur. Linear contrasts performed with Bonferroni adjustment (alpha=0.025)|Positive values for the treatment group difference favor the HB-C group. Results of the treatment group comparison are adjusted for baseline covariates of CISS, mean NPC break and mean PFV blur.|The primary outcome was success at 12 weeks. The sample size was computed to have 90% power to detect a treatment group difference between the HB-C versus HB-P groups, assuming true population success percentages of 30% and 10% for the HB-C and HB-PU groups, respectively, with a type I error rate of 2.5%. The treatment group comparison was adjusted for baseline covariates of CISS score (\<28 points vs ≥28 points), mean NPC break (\<10 cm vs ≥10 cm) and mean PFV blur (≥15 pd vs \<15 pd).||22|-12|0.52
71140562|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|2.47||||0.05|TWO_SIDED|95.0|1.0|6.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.09|1.00|0.0500
71140563|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|3.22||||0.0123|TWO_SIDED|95.0|1.29|8.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.03|1.29|0.0123
71140564|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|1.76||||0.2243|TWO_SIDED|95.0|0.71|4.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||4.37|0.71|0.2243
71140565|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|2.13||||0.0976|TWO_SIDED|95.0|0.87|5.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.24|0.87|0.0976
71140566|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|6.09||||0.0004|TWO_SIDED|95.0|2.25|16.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||16.44|2.25|0.0004
71140567|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|9.13|||<|0.0001|TWO_SIDED|95.0|3.04|27.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||27.40|3.04|<0.0001
70866360|NCT03779711|141218761|SUPERIORITY|||||||0.9563|||||||Kruskal-Wallis|||Kruskal-Wallis test for change in weight from baseline to 3-months post-surgery.||||0.9563
70866361|NCT03779711|141218762|SUPERIORITY|||||||0.9095|||||||Kruskal-Wallis|||Kruskal-Wallis test for change in heart rate from baseline to 3-months post-surgery.||||0.9095
70866362|NCT03779711|141218763|SUPERIORITY|||||||0.6391|||||||Kruskal-Wallis|||Kruskal-Wallis test for change in oxygen saturation from baseline to 3-months post-surgery.||||0.6391
70866363|NCT03779711|141218770|SUPERIORITY|||||||0.8782|||||||Kruskal-Wallis|||Kruskal-Wallis test comparing number of days in hospital post stage-II surgery||||0.8782
71140568|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|2.06||||0.1237|TWO_SIDED|95.0|0.82|5.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.17|0.82|0.1237
70866364|NCT05224141|141218771|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.9762|TWO_SIDED|95.0|1.0|1.59|||Log Rank|One-sided p-value based on log-rank test stratified by ECOG performance status, LDH, liver metastasis, and brain metastasis.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).|Statistical analyses stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).||1.59|1.00|0.9762
70866365|NCT05224141|141218772|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.5316|TWO_SIDED|95.0|0.82|1.23|||Log Rank|One-sided p-value based on log-rank test stratified by ECOG performance status, LDH, liver metastasis, and brain metastasis.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).|Statistical analyses stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).||1.23|0.82|0.5316
70866366|NCT05224141|141218773|SUPERIORITY||Percent Difference|-3.1|||||TWO_SIDED|95.0|-11.1|4.9|||||Based on Miettinen \& Nurminen method stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).|Statistical analyses stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).||4.9|-11.1|
70866367|NCT04873700|141218800|SUPERIORITY||||||=|0.0701|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Location of disease||||=0.0701
71140569|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|2.94||||0.0226|TWO_SIDED|95.0|1.16|7.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.41|1.16|0.0226
71140570|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|3.55||||0.0069|TWO_SIDED|95.0|1.42|8.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||8.91|1.42|0.0069
71140571|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|1.9||||0.1666|TWO_SIDED|95.0|0.76|4.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.75|0.76|0.1666
71140572|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0317|TWO_SIDED|95.0|1.09|6.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.67|1.09|0.0317
71140573|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0011|TWO_SIDED|95.0|1.94|14.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||14.39|1.94|0.0011
71140574|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|8.45||||0.0001|TWO_SIDED|95.0|2.81|25.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||25.46|2.81|0.0001
71140575|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|2.1||||0.1142|TWO_SIDED|95.0|0.84|5.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.27|0.84|0.1142
71140576|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|2.91||||0.025|TWO_SIDED|95.0|1.14|7.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.39|1.14|0.0250
71140577|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|3.08||||0.0166|TWO_SIDED|95.0|1.23|7.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.75|1.23|0.0166
71140578|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|1.27||||0.6033|TWO_SIDED|95.0|0.52|3.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.11|0.52|0.6033
71140579|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|2.05||||0.117|TWO_SIDED|95.0|0.84|5.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.02|0.84|0.1170
71140580|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|2.69||||0.04|TWO_SIDED|95.0|1.05|6.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.91|1.05|0.0400
71140581|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|5.61||||0.002|TWO_SIDED|95.0|1.88|16.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||16.72|1.88|0.0020
71140582|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|1.35||||0.5177|TWO_SIDED|95.0|0.54|3.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.37|0.54|0.5177
71140583|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|1.79||||0.2117|TWO_SIDED|95.0|0.72|4.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.48|0.72|0.2117
71140584|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0426|TWO_SIDED|95.0|1.03|6.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.67|1.03|0.0426
71140585|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|1.54||||0.3508|TWO_SIDED|95.0|0.62|3.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.82|0.62|0.3508
71140586|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|1.42||||0.4431|TWO_SIDED|95.0|0.58|3.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.45|0.58|0.4431
71140587|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|4.27||||0.005|TWO_SIDED|95.0|1.55|11.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||11.78|1.55|0.0050
71140588|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|5.47||||0.0023|TWO_SIDED|95.0|1.84|16.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||16.30|1.84|0.0023
71140589|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|1.31||||0.5663|TWO_SIDED|95.0|0.52|3.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.32|0.52|0.5663
71140590|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0461|TWO_SIDED|95.0|1.02|6.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.83|1.02|0.0461
71140591|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|2.5||||0.0552|TWO_SIDED|95.0|0.98|6.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.38|0.98|0.0552
71140592|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|1.95||||0.1536|TWO_SIDED|95.0|0.78|4.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.88|0.78|0.1536
71140593|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|1.69||||0.2575|TWO_SIDED|95.0|0.68|4.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.20|0.68|0.2575
71140594|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|3.73||||0.0096|TWO_SIDED|95.0|1.38|10.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.11|1.38|0.0096
70948719|NCT01515943|141398440|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-7.0|||<|0.01|TWO_SIDED|95.0|-27.0|17.0|||Bernard's exact test|A p-value was not reported in the manuscript results, but has been included here, reported directly from the analysis.||For the HB-C group, the association between completion of the computer vergence/accommodative therapy (CVAT) program (defined as achieving at least 15 stars for the jump vergence exercise) and overall success at 12 weeks was evaluated using Bernard's exact test.||17|-27|<0.01
70948720|NCT05224843|141398447|OTHER||Percentage of enrolled from eligible|82.5|||||TWO_SIDED|95.0|73.7|88.8||||||||88.8|73.7|
71140595|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|8.48||||0.0003|TWO_SIDED|95.0|2.69|26.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||26.76|2.69|0.0003
71140596|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|2.18||||0.1047|TWO_SIDED|95.0|1.48|10.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.35|1.48|0.1047
70866368|NCT04873700|141218800|SUPERIORITY||||||=|0.1383|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Disease behavior||||=0.1383
70948721|NCT05224843|141398448|OTHER||Percentage of enrolled from eligible|100.0|||||TWO_SIDED|95.0|95.4|100.0||||||||100|95.4|
71140597|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|3.91||||0.006|TWO_SIDED|95.0|1.48|10.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.35|1.48|0.0060
71140598|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0414|TWO_SIDED|95.0|1.04|6.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.71|1.04|0.0414
71140599|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|2.31||||0.0809|TWO_SIDED|95.0|0.9|5.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.89|0.90|0.0809
71140600|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|1.74||||0.2377|TWO_SIDED|95.0|0.69|4.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.34|0.69|0.2377
71140601|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|4.21||||0.0087|TWO_SIDED|95.0|1.44|12.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||12.34|1.44|0.0087
71140602|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|6.0||||0.0022|TWO_SIDED|95.0|1.9|18.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||18.94|1.90|0.0022
71140603|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|1.4||||0.4788|TWO_SIDED|95.0|0.55|3.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.55|0.55|0.4788
71140604|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|3.98||||0.0074|TWO_SIDED|95.0|1.45|10.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||10.94|1.45|0.0074
70866369|NCT04873700|141218800|SUPERIORITY||||||=|0.0478|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Perianal disease||||=0.0478
70948722|NCT05224843|141398450|OTHER||Percentage screened positive for EM|7.5|||||TWO_SIDED|95.0|3.5|15.4||||||||15.4|3.5|
70948723|NCT05224843|141398452|OTHER||Percentage who changed after BNI|25.0|||||TWO_SIDED|95.0|4.6|69.9||||||||69.9|4.6|
70948724|NCT05224843|141398453|OTHER||Percentage reported APS from EM positive|20.0|||||TWO_SIDED|95.0|3.6|62.4||||||||62.4|3.6|
71140605|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|3.26||||0.0187|TWO_SIDED|95.0|1.22|8.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.75|1.22|0.0187
71140606|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|1.57||||0.3443|TWO_SIDED|95.0|0.62|4.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.00|0.62|0.3443
70866370|NCT04873700|141218800|SUPERIORITY||||||=|0.1454|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Ileal disease||||=0.1454
70866371|NCT04873700|141218800|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Peripheral arthritis||||=1.0000
71140607|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|1.66||||0.2867|TWO_SIDED|95.0|0.65|4.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.22|0.65|0.2867
71140608|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|5.12||||0.0044|TWO_SIDED|95.0|1.66|15.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||15.78|1.66|0.0044
71140609|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|5.58||||0.0038|TWO_SIDED|95.0|1.74|17.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||17.87|1.74|0.0038
71140610|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|2.09||||0.1424|TWO_SIDED|95.0|0.78|5.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.60|0.78|0.1424
71140611|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|3.32||||0.0191|TWO_SIDED|95.0|1.22|9.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||9.07|1.22|0.0191
71140612|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|3.15||||0.0244|TWO_SIDED|95.0|1.16|8.56||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.56|1.16|0.0244
71140613|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|2.63||||0.1462|TWO_SIDED|95.0|0.71|9.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.67|0.71|0.1462
71140614|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|1.26||||0.7403|TWO_SIDED|95.0|0.32|4.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||4.97|0.32|0.7403
71140615|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|2.35||||0.2144|TWO_SIDED|95.0|0.61|9.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.07|0.61|0.2144
71140616|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|1.74||||0.4321|TWO_SIDED|95.0|0.44|6.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.96|0.44|0.4321
71140617|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|2.53||||0.1778|TWO_SIDED|95.0|0.66|9.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.75|0.66|0.1778
70866372|NCT04873700|141218800|SUPERIORITY||||||=|0.4992|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Aphthous ulcers||||=0.4992
70866373|NCT04873700|141218800|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Episcleritis||||=1.0000
70866374|NCT04873700|141218800|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Uveitis||||=1.0000
70866375|NCT04873700|141218800|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Osteoporosis||||=1.0000
70948725|NCT01245140|141398483|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5731||||0.9705|TWO_SIDED|95.0|-30.9738|32.12|||ANCOVA|||||32.1200|-30.9738|0.9705
70948726|NCT01245140|141398484|SUPERIORITY_OR_OTHER|||||||0.4564||95.0||||PPPASI 50 response|Fisher Exact|||||||0.4564
70948727|NCT01245140|141398484|SUPERIORITY_OR_OTHER|||||||0.6595||95.0||||PPPASI 75 response|Fisher Exact|||||||0.6595
71140618|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|1.21||||0.8016|TWO_SIDED|95.0|0.28|5.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.20|0.28|0.8016
71140619|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|2.62||||0.1486|TWO_SIDED|95.0|0.71|9.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.64|0.71|0.1486
71140620|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|0.51||||0.2881|TWO_SIDED|95.0|0.15|1.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.77|0.15|0.2881
70866376|NCT04873700|141218800|SUPERIORITY||||||=|0.2022|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Anemia||||=0.2022
70866377|NCT04873700|141218800|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Hematological alteration||||=1.0000
70866378|NCT04873700|141218800|SUPERIORITY||||||=|0|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Other||||=0.0000
70866379|NCT04873700|141218801|SUPERIORITY||||||=|0.2896|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Location of disease||||=0.2896
70866380|NCT04873700|141218801|SUPERIORITY||||||=|0.0006|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Disease behavior||||=0.0006
70948728|NCT01245140|141398486|SUPERIORITY_OR_OTHER|||||||0.51||95.0||||Change in Total Pustule Count: BL to Last Visit|Wilcoxon test: Exact Test|||||||0.51
70948729|NCT01245140|141398487|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||Relative change in mPASI score: BL to Last Visit|Wilcoxon test: Exact Test|||||||0.12
70866381|NCT04873700|141218801|SUPERIORITY||||||=|0.089|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Peripheral arthritis||||=0.0890
70948730|NCT01245140|141398488|SUPERIORITY_OR_OTHER||Least squared estimation|49.4927||||0.2358|TWO_SIDED|95.0|-49.083|148.07|||ANCOVA|||||148.07|-49.0830|0.2358
70948731|NCT01245140|141398489|SUPERIORITY_OR_OTHER|||||||0.1667||95.0||||mPASI 50 response|Fisher Exact|||||||0.1667
70866382|NCT04873700|141218801|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Pyoderma gangrenosum||||=1.0000
70866383|NCT04873700|141218801|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Aphthous ulcers||||=1.0000
70866384|NCT04873700|141218801|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Primary sclerosing cholangitis||||=1.0000
70866385|NCT04873700|141218801|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Osteoporosis||||=1.0000
70866386|NCT04873700|141218801|SUPERIORITY||||||=|0.0752|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Anemia||||=0.0752
70866387|NCT04873700|141218801|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Hematological alteration||||=1.0000
70866388|NCT04873700|141218801|SUPERIORITY||||||=|0.1032|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Other||||=0.1032
70866389|NCT01961362|141218820|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_DEVIATION|0.87||0.6|TWO_SIDED|||||P\<0.05 considered to represent statistical significance.|t-test, 2 sided|||||||0.6
70866390|NCT01961362|141218820|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|1.2|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
70866391|NCT01961362|141218821|SUPERIORITY||Median Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|1.2|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
70948732|NCT01245140|141398489|SUPERIORITY_OR_OTHER|||||||0.1667||95.0||||mPASI 75 response|Fisher Exact|||||||0.1667
70948733|NCT04836559|141398508|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.3571|TWO_SIDED|95.0|0.41|1.38|||t-test, 1 sided|||||1.38|0.41|0.3571
70948734|NCT04836559|141398508|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.6306|TWO_SIDED|95.0|0.4|1.75|||t-test, 1 sided|||||1.75|0.40|0.6306
70866392|NCT00467857|141218827|SUPERIORITY_OR_OTHER|||||||0.655||95.0|||||Wilcoxon-Rank Sum Test|||The sample size determination was selected to achieve 80% power to detect an absolute 10% difference between the two treatment groups in proportion of qualitative reduction in representative skin flora, at a significance level (alpha) of 0.05 using a two-sided z-test with continuity correction.||||0.655
70866393|NCT00467857|141218828|SUPERIORITY_OR_OTHER|||||||0.276||95.0|||||Wilcoxon-Rank Sum Test|||||||0.276
70866394|NCT00467857|141218829|SUPERIORITY_OR_OTHER|||||||0.375||95.0|||||Wilcoxon-Rank Sum Test|||||||0.375
70866395|NCT00467857|141218830|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Wilcoxon-Rank Sum Test|||||||0.039
70866396|NCT00467857|141218831|SUPERIORITY_OR_OTHER|||||||0.057||95.0|||||Wilcoxon-Rank Sum Test|||||||0.057
70866397|NCT00467857|141218832|SUPERIORITY_OR_OTHER|||||||0.646||95.0|||||Wilcoxon-Rank Sum Test|||||||0.646
70866398|NCT00467857|141218833|SUPERIORITY_OR_OTHER|||||||0.788||95.0|||||Wilcoxon-Rank Sum Test|||||||0.788
70866399|NCT00467857|141218834|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||Wilcoxon-Rank Sum Test|||||||0.960
70866400|NCT00467857|141218835|SUPERIORITY_OR_OTHER|||||||0.359||95.0|||||Wilcoxon-Rank Sum Test|||The sample size determination was selected to achieve 80% power to detect an absolute 10% difference between the two treatment groups in proportion of qualitative reduction in representative skin flora, at a significance level (alpha) of 0.05 using a two-sided z-test with continuity correction.||||0.359
70866401|NCT00467857|141218836|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Wilcoxon-Rank Sum Test|||||||0.730
70866402|NCT00467857|141218837|SUPERIORITY_OR_OTHER|||||||0.348||95.0|||||Wilcoxon-Rank Sum Test|||||||0.348
70866403|NCT00467857|141218838|SUPERIORITY_OR_OTHER|||||||0.512||95.0|||||Wilcoxon-Rank Sum Test|||||||0.512
70866404|NCT00467857|141218839|SUPERIORITY_OR_OTHER|||||||0.285||95.0|||||Chi-squared|||||||0.285
70866405|NCT00467857|141218840|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||Fisher Exact|||||||0.024
70866406|NCT02298023|141218856|OTHER|||||||0.35|||||||Kruskal-Wallis|||Null hypothesis: There is no difference between the three groups. Statistical power: 0.80||||0.35
70866407|NCT02298023|141218857|EQUIVALENCE|To test whether there were differences in the rate of change among groups||||||0.662|||||||Mixed Models Analysis|||||||0.662
70866408|NCT02298023|141218858|EQUIVALENCE|To test whether there were differences in the rate of change among groups||||||0.882|||||||Mixed Models Analysis|||||||0.882
70948735|NCT02701062|141398549|SUPERIORITY|||||||0.2593|||||||Fisher Exact|||||||0.2593
70948736|NCT02701062|141398550|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
70948737|NCT02701062|141398551|SUPERIORITY|||||||0.1238|||||||Fisher Exact|||||||0.1238
70948738|NCT02701062|141398552|SUPERIORITY|||||||0.6603|||||||t-test, 2 sided|||LOS (Total)||||0.6603
70948739|NCT02701062|141398552|SUPERIORITY|||||||0.0783|||||||t-test, 2 sided|||LOS (Post-Procedure)||||0.0783
70948740|NCT02701062|141398552|SUPERIORITY|||||||0.4282|||||||t-test, 2 sided|||Readmission LOS (per subject)||||0.4282
70866409|NCT02298023|141218859|EQUIVALENCE|To test whether there were differences in the rate of change among groups||||||0.835|||||||Mixed Models Analysis|||||||0.835
70866410|NCT02298023|141218860|EQUIVALENCE|To test whether there were differences in the rate of change among groups||||||0.977|||||||Mixed Models Analysis|||||||0.977
70866411|NCT02298023|141218861|EQUIVALENCE|To test whether there were differences in the rate of change among groups||||||0.867|||||||Mixed Models Analysis|||||||0.867
70866412|NCT02298023|141218862|EQUIVALENCE|To test whether there were differences in the change of tear size among groups||||||0.916|||||||Chi-squared|||||||0.916
70866413|NCT02298023|141218863|EQUIVALENCE|To test whether there were differences in the change of tear size among groups||||||0.892|||||||Chi-squared|||||||0.892
70866414|NCT02002832|141218884|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|LS mean for the treatment difference(lurasidone-risperidone) at week 6 and its 95% confidence interval was presented based on the MMRM. Non-inferiority for lurasidone relative to risperidone was evaluated by comparing the upper bound of the 95% confidence interval to the non-inferiority margin of 7.0. Plots of estimates for change from baseline in PANSS total score based on MMRM over time (Week 1 to Week 6) with 95% confidence intervals was provided for each treatment group.|Mean Difference (Final Values)|3.7|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|95.0|1.0|6.3|||Mixed Models Analysis|||||6.3|1.0|
70866415|NCT00492531|141219123|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.0||||0.7|TWO_SIDED|95.0|-56.0|38.0|||ANCOVA|6 minute walk was based on ANCOVA model with treatment as a fixed effect and 6 minute walk distance, TRV stratum and study site as covariate.||||38|-56|0.70
70866416|NCT00843856|141219131|SUPERIORITY|||||||0.7|||||||Fisher Exact|||||||0.7
70866417|NCT04729621|141219133|EQUIVALENCE|Biosimilarity will be demonstrated if the 95% CI for the difference falls entirely within the equivalence margin of (-1.45, +1.45).|Mean Difference (Net)|0.21|||||TWO_SIDED|95.0|-0.73|1.15||||||LS means, differences and confidence intervals (CI) from the ANCOVA model with percent change from baseline to Week 52 in LS-BMD as the outcome, treatment group, region and previous use of bisphosphates as fixed effects, baseline LS-BMD and baseline weight as covariates. Missing outcomes imputed using multiple imputation methods under the MAR assumption.||1.15|-0.73|
70866418|NCT04729621|141219134|EQUIVALENCE|Biosimilarity will be demonstrated if the 95% CI for the difference falls entirely within the equivalence margin of (-20, +20).|Mean Difference (Net)|9.07|||||TWO_SIDED|95.0|-0.14|18.29||||||LS means, differences and confidence intervals (CI) from the ANCOVA model with percent change from baseline to Week 26 in sCTX-1 as the outcome, treatment group, region and previous use of bisphosphates as fixed effects, baseline sCTX-1 and baseline weight as covariates. Missing outcomes are not imputed. Results below the limit of quantification (BLQ) are imputed as the low limit of quantification (LLOQ = 0.033 ng/mL).||18.29|-0.14|
70866419|NCT03104543|141219158|SUPERIORITY||Risk Ratio (RR)|0.99||||0.05|TWO_SIDED|95.0|0.67|1.45|||Generalized estimating equation|||||1.45|0.67|.05
70866420|NCT03104543|141219161|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.05|TWO_SIDED|95.0|-0.47|0.28|||t-test, 2 sided|||||0.28|-0.47|.05
70866421|NCT00319501|141219174|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55||||0.012|TWO_SIDED|95.0|0.34|0.88||p-value is adjusted. All statistical tests were 2-sided and employed a level of significance of alpha=0.05.|Cox Proportional Hazard||Age adjusted|Null hypothesis||0.88|0.34|0.012
70866422|NCT00319501|141219176|SUPERIORITY_OR_OTHER|||||||0.066|TWO_SIDED|||||p-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha=0.05.|Fisher Exact|||||||0.066
70866423|NCT00319501|141219177|SUPERIORITY_OR_OTHER|||||||0.443|||||||Fisher Exact|||||||0.443
70866424|NCT00319501|141219178|SUPERIORITY_OR_OTHER|||||||0.245|TWO_SIDED|||||p-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha=0.05.|Fisher Exact|||||||0.245
70866425|NCT00319501|141219179|SUPERIORITY_OR_OTHER||Difference in least square means|0.75||||0.086|TWO_SIDED|95.0|-0.11|1.61||p-Value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|ANOVA|ANOVA=analysis of variance.|Model included treatment and age category.|||1.61|-0.11|0.086
70866426|NCT00319501|141219180|SUPERIORITY_OR_OTHER||Difference in least square means|0.79||||0.045|TWO_SIDED|95.0|0.02|1.56||p-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha=0.05.|ANOVA||Model included treatment and age category.|||1.56|0.02|0.045
70866427|NCT01696071|141219190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.018||||95.0|-0.038|0.034|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 QD - Tio R2.5 BID|No p-values are presented as no formal statistical hypothesis was tested.||0.034|-0.038|
70866428|NCT01696071|141219191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.021||||95.0|-0.032|0.052|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested.||0.052|-0.032|
70866429|NCT01696071|141219192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.018||||95.0|-0.05|0.022|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested||0.022|-0.050|
70866430|NCT01696071|141219193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.018||||95.0|-0.051|0.023|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested.||0.023|-0.051|
70866431|NCT01696071|141219194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.032||||95.0|-0.06|0.068|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested.||0.068|-0.060|
70866432|NCT01696071|141219195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.02||||95.0|-0.044|0.035|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested.||0.035|-0.044|
70866433|NCT01696071|141219196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.023||||95.0|-0.048|0.042|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested||0.042|-0.048|
70948741|NCT02701062|141398553|SUPERIORITY|||||||0.6603|||||||t-test, 2 sided|||||||0.6603
70948742|NCT02701062|141398553|SUPERIORITY|||||||0.0783|||||||t-test, 2 sided|||LOS (Post-Procedure)||||0.0783
70866434|NCT01696071|141219197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.02||||95.0|-0.047|0.034|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested||0.034|-0.047|
70866435|NCT01696071|141219198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.026||||95.0|-0.07|0.032|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested||0.032|-0.070|
70866436|NCT01696071|141219199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.041|STANDARD_ERROR_OF_MEAN|0.035||||95.0|-0.03|0.111|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested||0.111|-0.030|
70866437|NCT01696071|141219200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.389|STANDARD_ERROR_OF_MEAN|3.658||||95.0|-8.651|5.873|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested||5.873|-8.651|
70866438|NCT03572972|141219201|SUPERIORITY||Hazard Ratio (HR)|0.618|||||TWO_SIDED|95.0|0.541|0.707||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of hazard ratio (HR) at year 1 as an extended Cox model was used.||0.707|0.541|
70948743|NCT02701062|141398553|SUPERIORITY|||||||0.4282|||||||t-test, 2 sided|||Readmission LOS (per subject)||||0.4282
70948744|NCT02701062|141398554|SUPERIORITY|||||||0.5442|||||||Fisher Exact|||Reoperation||||0.5442
70948745|NCT02701062|141398554|SUPERIORITY|||||||0.2598|||||||Fisher Exact|||ED Visit||||0.2598
70948746|NCT02701062|141398554|SUPERIORITY|||||||0.5442|||||||Fisher Exact|||Neurologic Consult||||0.5442
70866439|NCT03572972|141219201|SUPERIORITY||Hazard Ratio (HR)|0.604|||||TWO_SIDED|95.0|0.53|0.687||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.687|0.530|
71140621|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|0.36||||0.1217|TWO_SIDED|95.0|0.1|1.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.31|0.10|0.1217
70866440|NCT03572972|141219201|SUPERIORITY||Hazard Ratio (HR)|0.705|||||TWO_SIDED|95.0|0.563|0.884|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.884|0.563|
70948747|NCT02701062|141398554|SUPERIORITY|||||||0.2921|||||||Fisher Exact|||Hospital Readmission (per subject)||||0.2921
70948748|NCT00781937|141398580|SUPERIORITY_OR_OTHER||Treatment Contrast|-6.06|||<|0.0001||95.0|-7.5|-4.62||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3) and the hypotheses of equality between liraglutide and placebo for each were tested in a hierarchical manner; i.e. a conclusion of liraglutide superiority for a given co-primary endpoint could be drawn only if all preceding hypotheses of equality in the hierarchy had been rejected.||-4.62|-7.50|<0.0001
71140622|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|0.36||||0.1027|TWO_SIDED|95.0|0.07|1.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.28|0.07|0.1027
71140623|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|0.18||||0.0428|TWO_SIDED|95.0|0.03|0.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||0.94|0.03|0.0428
70866441|NCT03572972|141219202|SUPERIORITY||Hazard Ratio (HR)|0.993|||||TWO_SIDED|95.0|0.87|1.134||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.134|0.870|
70866442|NCT03572972|141219202|SUPERIORITY||Hazard Ratio (HR)|0.949|||||TWO_SIDED|95.0|0.839|1.073||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.073|0.839|
70866443|NCT03572972|141219202|SUPERIORITY||Hazard Ratio (HR)|0.961|||||TWO_SIDED|95.0|0.854|1.082||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.082|0.854|
70866444|NCT03572972|141219203|SUPERIORITY||Hazard Ratio (HR)|0.583|||||TWO_SIDED|95.0|0.512|0.664||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.664|0.512|
70866445|NCT03572972|141219203|SUPERIORITY||Hazard Ratio (HR)|0.754|||||TWO_SIDED|95.0|0.597|0.953|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.953|0.597|
70866446|NCT03572972|141219203|SUPERIORITY||Hazard Ratio (HR)|0.844|||||TWO_SIDED|95.0|0.685|1.04|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.040|0.685|
70866447|NCT03572972|141219204|SUPERIORITY||Hazard Ratio (HR)|0.866|||||TWO_SIDED|95.0|0.761|0.985||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.985|0.761|
70866448|NCT03572972|141219204|SUPERIORITY||Hazard Ratio (HR)|0.768|||||TWO_SIDED|95.0|0.684|0.862||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.862|0.684|
71140624|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|0.72||||0.5943|TWO_SIDED|95.0|0.21|2.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.44|0.21|0.5943
71140625|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|0.94||||0.928|TWO_SIDED|95.0|0.27|3.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.28|0.27|0.9280
71140626|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|0.94||||0.916|TWO_SIDED|95.0|0.3|2.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.94|0.30|0.9160
71140627|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|0.43||||0.2262|TWO_SIDED|95.0|0.11|1.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.69|0.11|0.2262
71140628|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|0.48||||0.2682|TWO_SIDED|95.0|0.13|1.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.75|0.13|0.2682
71140629|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|0.4||||0.2344|TWO_SIDED|95.0|0.09|1.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.81|0.09|0.2344
71140630|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|0.22||||0.0835|TWO_SIDED|95.0|0.04|1.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.22|0.04|0.0835
71140631|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|0.72||||0.6322|TWO_SIDED|95.0|0.19|2.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.72|0.19|0.6322
70948749|NCT00781937|141398581|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.82|||<|0.0001||95.0|3.01|7.71||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3) and the hypotheses of equality between liraglutide and placebo for each were tested in a hierarchical manner; i.e. a conclusion of liraglutide superiority for a given co-primary endpoint could be drawn only if all preceding hypotheses of equality in the hierarchy had been rejected.||7.71|3.01|<0.0001
70948750|NCT00781937|141398582|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.86|||<|0.0001||95.0|2.44|6.09||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3) and the hypotheses of equality between liraglutide and placebo for each were tested in a hierarchical manner; i.e. a conclusion of liraglutide superiority for a given co-primary endpoint could be drawn only if all preceding hypotheses of equality in the hierarchy had been rejected.||6.09|2.44|<0.0001
70948751|NCT00781937|141398583|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.3|||<|0.0001||95.0|2.79|10.08||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.||||10.08|2.79|<0.0001
70948752|NCT00781937|141398584|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.09|||<|0.0001||95.0|0.03|0.26||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.||||0.26|0.03|<0.0001
71140632|NCT03192176|141778526|SUPERIORITY||Odds Ratio (OR)|0.65||||0.4845|TWO_SIDED|95.0|0.2|2.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.17|0.20|0.4845
71140633|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9587|TWO_SIDED|95.0|0.06|17.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||17.98|0.06|0.9587
71140634|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9895|TWO_SIDED|95.0|0.06|16.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.89|0.06|0.9895
71140635|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|7.24||||0.0736|TWO_SIDED|95.0|0.83|63.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||63.32|0.83|0.0736
71140636|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|7.08||||0.0767|TWO_SIDED|95.0|0.81|61.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||61.78|0.81|0.0767
71140637|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|3.51||||0.288|TWO_SIDED|95.0|0.35|35.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||35.49|0.35|0.2880
70948753|NCT00781937|141398586|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.86|||<|0.0001||95.0|3.12|10.98||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.||||10.98|3.12|<0.0001
70948754|NCT00781937|141398587|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.02|||<|0.0001||95.0|3.65|9.92||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.||||9.92|3.65|<0.0001
70948755|NCT00781937|141398588|SUPERIORITY_OR_OTHER||Treatment Contrast|-5.86|||<|0.0001||95.0|-7.3|-4.43||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-4.43|-7.30|<0.0001
70948756|NCT00781937|141398589|SUPERIORITY_OR_OTHER||Treatment Contrast|-4.23|||<|0.0001||95.0|-6.04|-2.43||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-2.43|-6.04|<0.0001
71140638|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|1.96||||0.5894|TWO_SIDED|95.0|0.17|22.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||22.47|0.17|0.5894
71140639|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|2.45||||0.3093|TWO_SIDED|95.0|0.44|13.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||13.78|0.44|0.3093
71140640|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|3.31||||0.1606|TWO_SIDED|95.0|0.62|17.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||17.58|0.62|0.1606
70948757|NCT00781937|141398590|SUPERIORITY_OR_OTHER||Treatment Contrast|-2.72||||0.0068||95.0|-4.69|-0.76||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||Analysis is of treatment contrast, change in systolic blood pressure.||-0.76|-4.69|0.0068
71140641|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|11.92||||0.0019|TWO_SIDED|95.0|2.5|56.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||56.87|2.50|0.0019
71140642|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|14.4||||0.0008|TWO_SIDED|95.0|3.02|68.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||68.73|3.02|0.0008
71140643|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|0.86||||0.8803|TWO_SIDED|95.0|0.11|6.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.55|0.11|0.8803
71140644|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|2.98||||0.2096|TWO_SIDED|95.0|0.54|16.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||16.46|0.54|0.2096
71140645|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|7.69||||0.011|TWO_SIDED|95.0|1.6|37.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||37.11|1.60|0.0110
71140646|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|3.09||||0.0845|TWO_SIDED|95.0|0.86|11.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||11.11|0.86|0.0845
71140647|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|2.83||||0.1094|TWO_SIDED|95.0|0.79|10.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.13|0.79|0.1094
71140648|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|8.97||||0.0004|TWO_SIDED|95.0|2.68|30.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||30.07|2.68|0.0004
71140649|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|7.11||||0.0016|TWO_SIDED|95.0|2.1|24.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||24.09|2.10|0.0016
71140650|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|1.71||||0.4375|TWO_SIDED|95.0|0.44|6.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.64|0.44|0.4375
71140651|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|3.02||||0.0898|TWO_SIDED|95.0|0.84|10.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.85|0.84|0.0898
71140652|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|6.32||||0.0027|TWO_SIDED|95.0|1.9|21.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||21.06|1.90|0.0027
71140653|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|2.44||||0.1242|TWO_SIDED|95.0|0.78|7.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.64|0.78|0.1242
71140654|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|2.66||||0.0815|TWO_SIDED|95.0|0.88|8.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.03|0.88|0.0815
71140655|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|6.21||||0.0009|TWO_SIDED|95.0|2.11|18.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||18.27|2.11|0.0009
71140656|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0027|TWO_SIDED|95.0|1.78|15.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||15.64|1.78|0.0027
70866449|NCT03572972|141219204|SUPERIORITY||Hazard Ratio (HR)|0.875|||||TWO_SIDED|95.0|0.786|0.975||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.975|0.786|
70866450|NCT03572972|141219205|SUPERIORITY||Hazard Ratio (HR)|0.673|||||TWO_SIDED|95.0|0.47|0.964||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.964|0.470|
70866451|NCT03572972|141219205|SUPERIORITY||Hazard Ratio (HR)|0.491|||||TWO_SIDED|95.0|0.337|0.715||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.715|0.337|
70866452|NCT03572972|141219205|SUPERIORITY||Hazard Ratio (HR)|0.747|||||TWO_SIDED|95.0|0.548|1.018||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.018|0.548|
70948758|NCT00781937|141398590|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.34||||0.6386||95.0|-1.74|1.07||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||Analysis is of treatment contrast, change in diastolic blood pressure.||1.07|-1.74|0.6386
70866453|NCT03572972|141219206|SUPERIORITY||Hazard Ratio (HR)|1.463|||||TWO_SIDED|95.0|0.998|2.145||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||2.145|0.998|
70866454|NCT03572972|141219206|SUPERIORITY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.647|1.225||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.225|0.647|
70948759|NCT00781937|141398591|SUPERIORITY_OR_OTHER||Treatment Contrast|0.97||||0.1968||95.0|-0.51|2.45||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||2.45|-0.51|0.1968
70948760|NCT00781937|141398592|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.11||||0.031||95.0|-0.2|-0.01||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-0.01|-0.20|0.0310
71140657|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|1.35||||0.6267|TWO_SIDED|95.0|0.41|4.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||4.46|0.41|0.6267
71140658|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|2.77||||0.0709|TWO_SIDED|95.0|0.92|8.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.38|0.92|0.0709
71140659|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|4.62||||0.0049|TWO_SIDED|95.0|1.59|13.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||13.59|1.59|0.0049
71140660|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|1.5||||0.5107|TWO_SIDED|95.0|0.45|4.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.98|0.45|0.5107
71140661|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|2.37||||0.1297|TWO_SIDED|95.0|0.78|7.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.22|0.78|0.1297
71140662|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|7.04||||0.0005|TWO_SIDED|95.0|2.34|21.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||21.22|2.34|0.0005
71140663|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|8.5||||0.0001|TWO_SIDED|95.0|2.82|25.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||25.63|2.82|0.0001
70866455|NCT03572972|141219206|SUPERIORITY||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.447|0.888||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.888|0.447|
70866456|NCT03572972|141219207|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.556|0.738||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.738|0.556|
70866457|NCT03572972|141219207|SUPERIORITY||Hazard Ratio (HR)|0.624|||||TWO_SIDED|95.0|0.544|0.715||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.715|0.544|
70866458|NCT03572972|141219207|SUPERIORITY||Hazard Ratio (HR)|0.749|||||TWO_SIDED|95.0|0.588|0.954|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.954|0.588|
70866459|NCT03572972|141219208|SUPERIORITY||Hazard Ratio (HR)|0.977|||||TWO_SIDED|95.0|0.85|1.122||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.122|0.850|
70866460|NCT03572972|141219208|SUPERIORITY||Hazard Ratio (HR)|0.966|||||TWO_SIDED|95.0|0.848|1.1||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.100|0.848|
70866461|NCT03572972|141219208|SUPERIORITY||Hazard Ratio (HR)|0.993|||||TWO_SIDED|95.0|0.877|1.125||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.125|0.877|
70866462|NCT03572972|141219209|SUPERIORITY||Hazard Ratio (HR)|0.25|||||TWO_SIDED|95.0|0.119|0.523||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.523|0.119|
70866463|NCT03572972|141219209|SUPERIORITY||Hazard Ratio (HR)|0.38|||||TWO_SIDED|95.0|0.203|0.711||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.711|0.203|
71140664|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|1.84||||0.299|TWO_SIDED|95.0|0.58|5.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.81|0.58|0.2990
71140665|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|2.38||||0.1355|TWO_SIDED|95.0|0.76|7.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.42|0.76|0.1355
71140666|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|5.17||||0.0028|TWO_SIDED|95.0|1.76|15.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||15.14|1.76|0.0028
71140667|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|1.2||||0.7422|TWO_SIDED|95.0|0.41|3.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.47|0.41|0.7422
71140668|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|2.44||||0.075|TWO_SIDED|95.0|0.91|6.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.52|0.91|0.0750
71140669|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|6.0||||0.0006|TWO_SIDED|95.0|2.16|16.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||16.67|2.16|0.0006
70948761|NCT00781937|141398593|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.09||||0.1098||95.0|-0.2|0.02||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||0.02|-0.20|0.1098
70948762|NCT00781937|141398594|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.11||||0.1149||95.0|-0.24|0.03||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||0.03|-0.24|0.1149
70948763|NCT00781937|141398595|SUPERIORITY_OR_OTHER||Treatment Contrast|-13.01||||0.0141||95.0|-23.4|-2.64||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-2.64|-23.40|0.0141
70866464|NCT03572972|141219209|SUPERIORITY||Hazard Ratio (HR)|0.422|||||TWO_SIDED|95.0|0.247|0.722||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.722|0.247|
70948764|NCT00781937|141398596|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.1199||95.0|0.36|1.12||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, and stratification factor(s) as fixed effects and metabolic status and weight at baseline as covariates.||||1.12|0.36|0.1199
70948765|NCT00781937|141398597|SUPERIORITY_OR_OTHER||Treatment Contrast|-3.5|||<|0.0001||95.0|-4.84|-2.15||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-2.15|-4.84|<0.0001
70948766|NCT00781937|141398598|SUPERIORITY_OR_OTHER||Treatment Contrast|-2.05|||<|0.0001||95.0|-2.53|-1.57||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-1.57|-2.53|<0.0001
70948767|NCT00781937|141398599|SUPERIORITY_OR_OTHER||Treatment Contrast|2.35||||0.3689||95.0|-2.79|7.49||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||7.49|-2.79|0.3689
70948768|NCT00781937|141398600|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.1||||0.0053||95.0|-0.16|-0.03||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-0.03|-0.16|0.0053
70948769|NCT00781937|141398601|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.38|||<|0.0001||95.0|-0.5|-0.26||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-0.26|-0.50|<0.0001
70948770|NCT00781937|141398602|SUPERIORITY_OR_OTHER||Treatment Contrast|-1.85||||0.0147||95.0|-3.34|-0.37||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-0.37|-3.34|0.0147
70948771|NCT00781937|141398603|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.27|||<|0.0001||95.0|-0.33|-0.21||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-0.21|-0.33|<0.0001
70948772|NCT01150045|141398607|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.12|TWO_SIDED|95.0|0.76|1.03|||Log Rank|||||1.03|0.76|0.12
70948773|NCT02489734|141398637|SUPERIORITY||Relative risk (RR)|3.4||||0.003|TWO_SIDED|95.0|1.4|8.1|||Chi-squared|||||8.1|1.4|0.003
70948774|NCT00420784|141398638|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.23|||<|0.001|TWO_SIDED|95.0|4.14|16.36|||Regression, Logistic|||||16.36|4.14|<0.001
70948775|NCT00420784|141398638|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.52|||<|0.001|TWO_SIDED|95.0|4.72|19.2|||Regression, Logistic|||||19.20|4.72|<0.001
70948776|NCT00420784|141398638|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.31||||0.024|TWO_SIDED|95.0|1.12|4.75|||Regression, Logistic|||||4.75|1.12|0.024
70948777|NCT00420784|141398640|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.64|||<|0.001|TWO_SIDED|95.0|3.41|12.96|||Regression, Logistic|||||12.96|3.41|<0.001
70948778|NCT00420784|141398640|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.72|||<|0.001|TWO_SIDED|95.0|2.91|11.27|||Regression, Logistic|||||11.27|2.91|<0.001
70948779|NCT00420784|141398640|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.95||||0.067|TWO_SIDED|95.0|0.95|4.0|||Regression, Logistic|||||4.00|0.95|0.067
70948780|NCT03603639|141398644|SUPERIORITY||LS Mean difference|1.38|||||TWO_SIDED|90.0|-0.72|3.48||||||The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||3.48|-0.72|
70948781|NCT03603639|141398644|SUPERIORITY||LS Mean difference|1.07|||||TWO_SIDED|90.0|-0.49|2.63||||||The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||2.63|-0.49|
70948782|NCT03603639|141398645|SUPERIORITY||LS Mean Difference|0.39|||||TWO_SIDED|90.0|-0.75|1.54||||||In eye closure condition. The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||1.54|-0.75|
70948783|NCT03603639|141398645|SUPERIORITY||LS Mean Difference|0.3|||||TWO_SIDED|90.0|-0.6|1.21||||||In eye closure condition. The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||1.21|-0.60|
70948784|NCT03603639|141398645|SUPERIORITY||LS Mean Difference|1.62|||||TWO_SIDED|90.0|-1.16|4.39||||||In eyes closed condition. The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||4.39|-1.16|
70948785|NCT03603639|141398645|SUPERIORITY||LS Mean Difference|1.05|||||TWO_SIDED|90.0|-0.89|2.98||||||In eyes closed condition. The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||2.98|-0.89|
70948786|NCT03603639|141398645|SUPERIORITY||LS Mean Difference|0.21|||||TWO_SIDED|90.0|-1.87|2.28||||||In eyes open condition. The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||2.28|-1.87|
70948787|NCT03603639|141398645|SUPERIORITY||LS Mean Difference|1.27|||||TWO_SIDED|90.0|-0.57|3.11||||||In eyes open condition. The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||3.11|-0.57|
70948788|NCT00607672|141398657|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||Mixed Models Analysis|||||||0.28
70948789|NCT00607672|141398658|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Mixed Models Analysis|||||||0.84
70948790|NCT00607672|141398659|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||Kruskal-Wallis|||||||0.67
70948791|NCT00607672|141398660|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Chi-squared|||||||0.73
70948792|NCT00607672|141398661|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||For plasma transfusion comparison. Ramipril and Candesartan versus placebo|Chi-squared|||||||0.04
70948793|NCT00607672|141398662|SUPERIORITY_OR_OTHER|||||||0.27||95.0||||Comparison for norepinephrine use|Chi-squared|||||||0.27
70948794|NCT00607672|141398663|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Chi-squared|||||||0.62
70948795|NCT00607672|141398664|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Chi-squared|||||||0.51
70948796|NCT00607672|141398665|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Chi-squared|||||||0.87
70948797|NCT00607672|141398666|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Kruskal-Wallis|||||||0.04
70948798|NCT00607672|141398667|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Mixed Models Analysis|||||||0.69
70948799|NCT00607672|141398668|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||Mixed Models Analysis|||||||0.97
70948800|NCT00607672|141398669|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||Mixed Models Analysis|||||||0.46
70948801|NCT04593823|141398685|SUPERIORITY||Win Ratio|1.11|||||TWO_SIDED|95.0|0.48|2.5|||||A win ratio parameter signifies the percentage of wins that a treatment group has achieved when compared against a comparator.|||2.50|0.48|
70948802|NCT04593823|141398686|SUPERIORITY||Mean Difference (Final Values)|2.9|||>|0.999|TWO_SIDED|95.0|-17.0|15.9|||Chi-squared|||||15.9|-17.0|>0.999
70948803|NCT04593823|141398687|SUPERIORITY||Median Difference (Final Values)|-8.8||||0.459|TWO_SIDED|95.0|-36.4|13.6|||Chi-squared|||||13.6|-36.4|0.459
70948804|NCT04593823|141398689|SUPERIORITY||Least Squares Mean Difference|8.887||||0.547|TWO_SIDED|95.0|-20.01|37.784|||ANOVA|Repeated measures analysis||||37.784|-20.010|0.547
70948805|NCT04593823|141398690|SUPERIORITY|||||||0.336|||||||Wilcoxon (Mann-Whitney)|||||||0.336
70948806|NCT00443209|141398713|SUPERIORITY_OR_OTHER||Treatment Difference|-6.2|||<|0.001|TWO_SIDED|95.0|-10.4|-2.6|||Miettenen and Nurminen method||Treatment Difference was compared using the Miettinen and Nurminen (MN) method.|||-2.6|-10.4|<0.001
70948807|NCT00443209|141398714|SUPERIORITY_OR_OTHER||Treatment Difference|-5.2|||||TWO_SIDED|95.0|-11.7|1.4|||||Treatment Difference was compared using the MN method.|||1.4|-11.7|
70948808|NCT00443209|141398715|SUPERIORITY_OR_OTHER||Treatment Difference|0.3|||||TWO_SIDED|95.0|-2.0|2.0|||||Treatment Difference was compared using the MN method.|||2.0|-2.0|
70948809|NCT00443209|141398717|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58|||||TWO_SIDED|95.0|0.45|0.75|||||Based on mixed logistic regression model with a fixed effect term for treatment, baseline pain severity and a random effect term for participant, with the random effect following a normal distribution. An odds ratio \>1 is in favor of telcagepant.|||0.75|0.45|
70948810|NCT01653210|141398725|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|||||||ANOVA|||||||0.023
70948811|NCT02781311|141398749|SUPERIORITY||Least-squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|4.45||0.9239|TWO_SIDED|95.0|-8.38|9.23||P-values were from analysis of covariance (ANCOVA) model including fixed effects of treatment, and covariates of age and baseline TAHC value, with the Type III sum of squares.|ANCOVA|||||9.23|-8.38|0.9239
70948812|NCT02781311|141398750|SUPERIORITY||Least-squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.9101|TWO_SIDED|95.0|-0.42|0.37||P-values were from analysis of covariance (ANCOVA) model including fixed effects of treatment, and covariates of age, with the Type III sum of squares.|ANCOVA|||||0.37|-0.42|0.9101
70948813|NCT01056263|141398751|SUPERIORITY_OR_OTHER||Five year survival probability|20.6|||||TWO_SIDED|95.0|10.94|32.38||||||Five year survival probability was the probability of survival at 5 year after the date of the start of the study treatment based on the Kaplan-Meier estimate.||32.38|10.94|
70948814|NCT01262092|141398752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2887||||0.035||95.0||||p values \<0.05 considered statistically significant|Mixed Models Analysis|Used proc GLIMMIX to model group by time (6 study visits)||"test null hypothesis that gbp and pla did not differ in terms of opioid-positive urines during the buprenorphine detox.~For the analysis, data from 2 participants in the GBP groups were excluded due to evidence of medication diversion (N=1) and not being maintained on the 1600 mg/day dose of GBP (N=1)."||||0.035
70948815|NCT03771638|141398753|SUPERIORITY|Minimum detectable effects: Under assumptions of the adherence of DBS TFV-DP levels \>=700 fmol/punch in the control condition as 60% and intraclass correlation of repeated binary measures of DBS TFV-DP of 0.69, and retention of 80% of participants at 24 weeks, we will have 80% power in 2-sided tests with a type-1 error rate of 5% to detect average between-group differences in adherence of 23 percentage points.|Risk Ratio (RR)|1.01||||0.94|TWO_SIDED|95.0|0.75|1.36||GEE poisson models with robust standard errors were used to assess DBS adherence rates, averaged across visits.|GEE Poisson models|||Null hypothesis: no difference in PrEP adherence levels between DOT Diary Intervention and Control arms||1.36|0.75|0.94
70948816|NCT03771638|141398754|OTHER||Kappa statistic|0.49|||||TWO_SIDED|95.0|0.36|0.62|||Kappa|||Kappa statistic to assess concordance between DBS measurement and self-reported PrEP use||0.62|0.36|
70948817|NCT03023423|141398760|SUPERIORITY||Odds Ratio (OR)|0.3|||||TWO_SIDED|95.0|0.03|1.92||||||||1.92|0.03|
70948818|NCT03512197|141398770|SUPERIORITY||Hazard Ratio (HR)|1.0239|||||TWO_SIDED|95.0|0.8|1.31||||||||1.31|0.8|
70948819|NCT03512197|141398771|SUPERIORITY||Hazard Ratio (HR)|0.8728|||||TWO_SIDED|95.0|0.59|1.29||||||||1.29|0.59|
70948820|NCT03512197|141398776|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.6|1.63||||||||1.63|0.60|
70948821|NCT03512197|141398777|SUPERIORITY||Hazard Ratio (HR)|1.5866|||||TWO_SIDED|95.0|0.88|2.87||||||||2.87|0.88|
70948822|NCT03512197|141398778|SUPERIORITY||Hazard Ratio (HR)|0.7937|||||TWO_SIDED|95.0|0.41|1.54||||||||1.54|0.41|
70948823|NCT03512197|141398780|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.75|1.16||||||partial neutrophil recovery||1.16|0.75|
70948824|NCT03512197|141398780|SUPERIORITY||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.72|1.14||||||full neutrophil recovery||1.14|0.72|
70948825|NCT03512197|141398781|SUPERIORITY||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.87|1.52||||||partial platelet recovery||1.52|0.87|
70948826|NCT03512197|141398781|SUPERIORITY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.67|1.0||||||full platelet recovery||1.00|0.67|
70948827|NCT01310699|141398809|SUPERIORITY|||||||0.21|||||||Chi-squared|||||||0.21
70948828|NCT01310699|141398810|SUPERIORITY|||||||0.18|||||||Chi-squared|||||||0.18
70948829|NCT02201901|141398819|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Binomial test|P-value is from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL 12 weeks (Group 1) over prespecified rate of 1% .||A sample size of 75 participants per treatment group would provide over 99% power to detect 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.0167.||||<0.001
70948830|NCT02201901|141398819|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Binomial test|P-value is from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL+RBV 12 weeks (Group 2) over prespecified rate of 1%.||A sample size of 75 participants per treatment group would provide over 99% power to detect 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.0167.||||<0.001
70948831|NCT02201901|141398819|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Binomial test|P-value is from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL 24 weeks (Group 3) over prespecified rate of 1%.||A sample size of 75 participants per treatment group would provide over 99% power to detect 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.0167.||||<0.001
70948832|NCT03358238|141398835|OTHER||Proportion|0.404|||||TWO_SIDED|95.0|0.264|0.557|||||Type of confidence interval = Clopper-Pearson|||0.557|0.264|
70948833|NCT03358238|141398836|SUPERIORITY||Difference in Average Proportions|0.0017||||0.99|TWO_SIDED|95.0|-0.1774|0.1807||Statistical significance was an alpha level of 0.05.|t-test, 2 sided|Two-sample t test. Degrees of freedom = 45.|Two-sample t confidence intervals|Null hypothesis was that the difference in average adherence rates of self-reporting between arms was zero.||0.1807|-0.1774|0.99
70866465|NCT03572972|141219210|SUPERIORITY||Hazard Ratio (HR)|0.745|||||TWO_SIDED|95.0|0.343|1.615||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.615|0.343|
70866466|NCT03572972|141219210|SUPERIORITY||Hazard Ratio (HR)|0.692|||||TWO_SIDED|95.0|0.342|1.402||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.402|0.342|
70866467|NCT03572972|141219210|SUPERIORITY||Hazard Ratio (HR)|0.932|||||TWO_SIDED|95.0|0.498|1.747||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.747|0.498|
70866468|NCT03572972|141219211|SUPERIORITY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.492|0.731||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.731|0.492|
70866469|NCT03572972|141219211|SUPERIORITY||Hazard Ratio (HR)|1.046|||||TWO_SIDED|95.0|0.719|1.522|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.522|0.719|
70866470|NCT03572972|141219211|SUPERIORITY||Hazard Ratio (HR)|1.295|||||TWO_SIDED|95.0|0.92|1.824|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.824|0.920|
70866471|NCT03572972|141219212|SUPERIORITY||Hazard Ratio (HR)|0.751|||||TWO_SIDED|95.0|0.62|0.91||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.91|0.62|
70866472|NCT03572972|141219212|SUPERIORITY||Hazard Ratio (HR)|0.697|||||TWO_SIDED|95.0|0.586|0.83||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.830|0.586|
70948834|NCT03358238|141398837|SUPERIORITY||Risk Difference (RD)|-0.0189||||0.85|TWO_SIDED|95.0|-0.2215|0.1837||Statistical significance was considered an alpha level of 0.05.|t-test, 2 sided|Two-sample t-test. Degrees of freedom = 45|Two-sample t confidence intervals|Null hypothesis was that the difference in average adherence rates to activity tracking between arms was zero.||0.1837|-0.2215|0.85
70866473|NCT03572972|141219212|SUPERIORITY||Hazard Ratio (HR)|0.936|||||TWO_SIDED|95.0|0.801|1.094||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.094|0.801|
70866474|NCT03572972|141219213|SUPERIORITY||Hazard Ratio (HR)|0.373|||||TWO_SIDED|95.0|0.212|0.658|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.658|0.212|
70866475|NCT03572972|141219213|SUPERIORITY||Hazard Ratio (HR)|0.538|||||TWO_SIDED|95.0|0.392|0.737||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.737|0.392|
70948835|NCT03358238|141398838|OTHER||Proportion|0.5385|||||TWO_SIDED|95.0|0.3718|0.6991|||||Type of confidence interval = Clopper-Pearson|Estimating proportion of individuals with higher adherence rates for self-report over activity tracking among individuals with unequal adherence rates||0.6991|0.3718|
70948836|NCT03358238|141398838|SUPERIORITY|||||||0.0828|||||||Chi-squared|Degrees of freedom = 1||Null hypothesis is that among individuals with unequal adherence rates, the proportion of individuals with greater adherence to self-report over activity tracking in the Review Arm is equal to the proportion of individuals with greater adherence to self-report over activity tracking in the No Review Arm.||||0.0828
70866476|NCT03572972|141219213|SUPERIORITY||Hazard Ratio (HR)|0.664|||||TWO_SIDED|95.0|0.507|0.87||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.870|0.507|
70866477|NCT03572972|141219214|SUPERIORITY||Hazard Ratio (HR)|1.204|||||TWO_SIDED|95.0|0.871|1.666||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.666|0.871|
70866478|NCT03572972|141219214|SUPERIORITY||Hazard Ratio (HR)|0.918|||||TWO_SIDED|95.0|0.691|1.218||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.218|0.691|
70866479|NCT03572972|141219214|SUPERIORITY||Hazard Ratio (HR)|0.771|||||TWO_SIDED|95.0|0.578|1.027||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.027|0.578|
70866480|NCT03572972|141219215|SUPERIORITY||Hazard Ratio (HR)|0.581|||||TWO_SIDED|95.0|0.481|0.701||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.701|0.481|
70866481|NCT03572972|141219215|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.534|0.766||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.766|0.534|
70866482|NCT03572972|141219215|SUPERIORITY||Hazard Ratio (HR)|0.838|||||TWO_SIDED|95.0|0.622|1.13|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.130|0.622|
70866483|NCT03572972|141219216|SUPERIORITY||Hazard Ratio (HR)|0.881|||||TWO_SIDED|95.0|0.732|1.061||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.061|0.732|
70866484|NCT03572972|141219216|SUPERIORITY||Hazard Ratio (HR)|0.802|||||TWO_SIDED|95.0|0.678|0.947||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.947|0.678|
70866485|NCT03572972|141219216|SUPERIORITY||Hazard Ratio (HR)|0.882|||||TWO_SIDED|95.0|0.754|1.032||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.032|0.754|
70872208|NCT01727297|141229672|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.65|TWO_SIDED|95.0|0.64|1.32||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having renal impairment on a patient's risk of developing AF.|The null hypothesis was that renal impairment did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.32|0.64|0.65
70948837|NCT03358238|141398839|OTHER||Mean Difference (Net)|0.79||||0.2|TWO_SIDED|95.0|-0.42|1.99||Statistical significance was considered an alpha level of 0.05.|t-test, 2 sided|One-sample t-test. Degrees of freedom = 46.|"One participant had a single item missing on the Young Mania Rating Scale administered at study start. A zero was imputed for the missing item to recover a total score.~One-sample t confidence intervals."|"One participant had a single item missing on the Young Mania Rating Scale administered at study start. A zero was imputed for the missing item to recover a total score.~Null hypothesis was that the average change in total scores was zero."||1.99|-0.42|0.20
70948838|NCT03358238|141398840|OTHER||Mean Difference (Net)|0.89||||0.32|TWO_SIDED|95.0|-0.91|2.7||Statistical significance was considered an alpha level of 0.05.|t-test, 2 sided|One-sample t test. Degrees of freedom = 46|One-sample t confidence intervals|Null hypothesis was that average change in scores on the structured interview guide for the Hamilton rating scale for depression is zero.||2.70|-0.91|0.32
70866486|NCT02569671|141219217|NON_INFERIORITY|"is less than the non-inferiority margin (indicating non-inferior bone gain).~The hypotheses associated with the primary analysis are defined as:~H0: µc - µs ≥ δ H1: µc - µs \< δ where µc is the mean change in crestal bone levels from implant loading to 12 months post-implant loading for the treatment group, µs is the mean change for the control group, and δ is the 0.5 mm non-inferiority margin. The hypotheses will be tested using a one-sided t-test with a 5% significance level."|Mean Difference (Final Values)|0.5|STANDARD_DEVIATION|0.5||0.95|ONE_SIDED|95.0||||SD for both test and control group is 0.5 mm, A difference between groups of ≥ 0.5 mm is considered clinically significant, The difference between the treatment groups is expected to be 0 mm, Statistical test will be one-sided 5% significance level.|t-test, 1 sided|The hypotheses will be tested using a one-sided t-test with a 5% significance level.|The hypotheses will be tested using a one-sided t-test with a 5% significance level.|The null hypothesis for the primary analysis is that the difference between the mean change in crestal bone levels for the treatment and control groups is at least the non-inferiority margin (indicating inferior bone gain). Rejection of the null hypothesis indicates the observed data supports the alternative hypothesis that the difference between the mean change in crestal bone levels for the treatment and control groups|The change in mean bone level from implant loading to 12-month follow-up was calculated. Change in crestal bone levels was calculated as the crestal bone level at 12-months post implant loading minus crestal bone level at implant loading.|||.950
70866487|NCT02569671|141219219|NON_INFERIORITY|Smaller bone dimensional thickness of the buccal plate measurements indicates less bone loss and better healing.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|0.3||0.022|ONE_SIDED|95.0|||||t-test, 1 sided|The hypotheses will be tested using a one-sided t-test with a 5% significance level.||All secondary effectiveness endpoints were planned to be summarized descriptively, and no hypothesis tests was planned.||||0.022
70866488|NCT01977794|141219250|SUPERIORITY_OR_OTHER||||||<|0.001||||||P value in both groups (Amlodipine failed and Bisoprolol failed) for comparison of SBP after 18 weeks versus baseline|Paired t test|||For each group (Amlodipine failed and Bisoprolol failed) SBP after 18 weeks compared to baseline (under monotherapy). Superiority was assessed between FDC and monotherapies.||||<0.001
70866489|NCT01895062|141219255|SUPERIORITY_OR_OTHER||||||<|0.022|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.022
70866490|NCT03228433|141219307|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with a fixed effect for regimen and random effect for participant. The least squares(LS) means and difference of least squares (LS) means for the log-transformed parameters were exponentiated to obtain the point estimates (Geometric LS means) of the food effect and 90% confidence intervals (CIs).|Least Squares (LS) Mean Difference|0.951|||||TWO_SIDED|90.0|0.823|1.099||||||||1.099|0.823|
70866491|NCT03228433|141219307|EQUIVALENCE|A linear regression model (power model), log (ln) (parameter) equal to (=) intercept plus (+) slope\*ln (dose), was fit to describe the relationship between each parameter and the corresponding dose levels. Dose Proportionality was declared if the 90% CI of the slope lied entirely within the critical region as defined by 1 - ln(0.8) per (/)l n(r) to 1 + ln(1.25)/ln(r), where r was the ratio of the highest and lowest dose in the study.|Slope|1.14|||||TWO_SIDED|90.0|1.04|1.25||||||||1.25|1.04|
70866492|NCT03228433|141219308|EQUIVALENCE|Bioequivalence interval of 627.51 to 659.59|LS Mean Difference|0.951|||||TWO_SIDED|90.0|0.825|1.097||||||||1.097|0.825|
70866493|NCT03228433|141219308|EQUIVALENCE|A linear regression model (power model), ln (parameter) = intercept + slope\*ln (dose), was fit to describe the relationship between each parameter and the corresponding dose levels. Dose Proportionality was declared if the 90% CI of the slope lied entirely within the critical region as defined by 1 - ln (0.8)/l n(r) to 1 + ln (1.25)/ln(r), where r was the ratio of the highest and lowest dose in the study.|Slope|1.11|||||TWO_SIDED|90.0|1.0|1.22||||||||1.22|1.00|
70866494|NCT03228433|141219309|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with a fixed effect for regimen and random effect for participant. The LS means and difference of LS means for the log-transformed parameters were exponentiated to obtain the point estimates (Geometric LS means) of the food effect and 90% confidence intervals CIs.|LS Mean Difference|0.58|||||TWO_SIDED|90.0|0.431|0.781||||||||0.781|0.431|
70866495|NCT03228433|141219309|EQUIVALENCE|A linear regression model (power model), ln (parameter) = intercept + slope\*ln (dose), was fit to describe the relationship between each parameter and the corresponding dose levels. Dose Proportionality was declared if the 90% CI of the slope lied entirely within the critical region as defined by 1 - ln (0.8)/l n(r) to 1 + ln (1.25)/ln(r), where r was the ratio of the highest and lowest dose in the study.|Slope|1.06||||||90.0|0.96|1.17||||||||1.17|0.96|
70866496|NCT01773733|141219312|OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
70948839|NCT01227616|141398841|NON_INFERIORITY|The study protocol defined the margin for non-inferiority as 0.5 g/dL meaning non-inferiority would be established in a TP if the lower limit of the 95% confidence limit for the difference between ferumoxytol and iron sucrose mean change was ≥0.5 g/dL.|Mean Difference (Final Values)|0.5|||<|0.05|TWO_SIDED||||||ANCOVA|Stats. of primary endpoint performed only for TP1 and TP2. 240 subjects retreated should yield 90% power to detect non-inferiority during TP2.||||||<0.05
70948840|NCT01431950|141398848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.077||||||95.0|-0.039|0.192||||||||0.192|-0.039|
70866497|NCT04424888|141219347|SUPERIORITY|||||||0.21875|||||||Wilcoxon (Mann-Whitney)|||||||0.21875
70866498|NCT04424888|141219348|SUPERIORITY|||||||0.90625|||||||Wilcoxon (Mann-Whitney)|||||||0.90625
71140670|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|7.63||||0.0001|TWO_SIDED|95.0|2.69|21.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||21.65|2.69|0.0001
71140671|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|1.12||||0.8405|TWO_SIDED|95.0|0.38|3.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.23|0.38|0.8405
71140672|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|1.3||||0.6257|TWO_SIDED|95.0|0.45|3.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.79|0.45|0.6257
70866499|NCT04424888|141219349|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||Paired t-test for the species Akkermansia Munciphilae.||||0.020
70866500|NCT04424888|141219349|SUPERIORITY|||||||0.078|||||||t-test, 1 sided|||Paired t-test for the species Bifidobacterium infantis.||||0.078
70866501|NCT04424888|141219349|SUPERIORITY|||||||||||||||||Paired t-test for the species Clostridium beijerinckii.|No statistical test was conducted since Clostridium beijerinckii was not detected in any sample.|||
70866502|NCT04424888|141219349|SUPERIORITY|||||||0.2|||||||t-test, 1 sided|||Paired t-test for the species Clostridium butyricum.||||0.20
70866503|NCT04424888|141219349|SUPERIORITY|||||||0.12|||||||t-test, 1 sided|||Paired t-test for the species Anaerobutyricum hallii.||||0.12
70866504|NCT04424888|141219350|OTHER||||||||||||||||||All participants had the same number of sensors (3) throughout the study, so no statistical analysis is conducted.|||
70866505|NCT04424888|141219351|SUPERIORITY|||||||0.41|||||||t-test, 1 sided|||We test whether the average number of daily photos is greater in period 1 than in period 2.||||0.41
70866506|NCT04424888|141219352|SUPERIORITY|||||||0.13|||||||t-test, 1 sided|||We test whether the average time between consecutive scans is smaller in period 1 than in period 2.||||0.13
70866507|NCT02390908|141219379|SUPERIORITY||Beta|0.22||||0.39|TWO_SIDED|95.0|-0.28|0.72||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 1 and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 1 on log-transformed Viral Load was estimated against the No-Treatment Control EMR Group.|||0.72|-0.28|0.39
70866508|NCT02390908|141219379|SUPERIORITY||Beta|-0.03||||0.94|TWO_SIDED|95.0|-0.84|0.79||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 2 and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 2 on log-transformed Viral Load was estimated against the No-Treatment Control EMR Group.|||0.79|-0.84|0.94
70866509|NCT02390908|141219379|SUPERIORITY||Beta|0.02||||0.95|TWO_SIDED|95.0|-0.69|0.74||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 3's Immediate Delivery Group and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 3 on log-transformed Viral Load was estimated against the No-Treatment Control EMR Group.|||0.74|-0.69|0.95
70866510|NCT02390908|141219379|SUPERIORITY||Beta|-0.32||||0.09|TWO_SIDED|95.0|-0.69|0.05||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 3 (the Waitlist condition) and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of being in the Waitlist condition (i.e., not receiving the PLUS intervention at Site 3) on log-transformed Viral Load was estimated against the No-Treatment Control EMR Group.|||0.05|-0.69|0.09
70866511|NCT02390908|141219379|SUPERIORITY||Slope|-0.03||||0.79|TWO_SIDED|95.0|-0.24|0.18||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in log VL across the 3-,6-,9- and 12-month follow-ups for Site 1 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.18|-0.24|0.79
70866512|NCT02390908|141219379|SUPERIORITY||Slope|-0.12||||0.57|TWO_SIDED|95.0|-0.53|0.36||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in log VL across the 3-,6-,9- and 12-month follow-ups for Site 2 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.36|-0.53|0.57
70866513|NCT02390908|141219379|SUPERIORITY||Slope|0.01||||0.97|TWO_SIDED|95.0|-0.35|0.36||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 here represents linear change in log VL across the 3-,6-,9- and 12-month follow-ups for Site 3 (Immediate) relative to the No-Treatment EMR Control.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.36|-0.35|0.97
70866514|NCT02390908|141219379|SUPERIORITY||Slope|0.07||||0.41|TWO_SIDED|95.0|-0.1|0.24||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in log VL across the 3-,6-,9- and 12-month follow-ups for Waitlist relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.24|-0.10|0.41
70866515|NCT02390908|141219379|SUPERIORITY||Slope|0.06||||0.82|TWO_SIDED|95.0|-0.41|0.52||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in log VL across the 12-,15-, and 18-month follow-ups for Site 1 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.52|-0.41|0.82
70866516|NCT02390908|141219379|SUPERIORITY||Slope|0.14||||0.49|TWO_SIDED|95.0|-0.26|0.53||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in log VL across the 12-,15-, and 18-month follow-ups for Site 2 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.53|-0.26|0.49
70866517|NCT02390908|141219379|SUPERIORITY||Slope|-0.33||||0.18|TWO_SIDED|95.0|-0.8|0.15||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in log VL across the 12-,15-, and 18-month follow-ups for Site 3 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.15|-0.80|0.18
70866518|NCT02390908|141219379|SUPERIORITY||Slope|0.02||||0.89|TWO_SIDED|95.0|-0.28|0.32||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in log VL across the 12-,15-, and 18-month follow-ups for Waitlist relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.32|-0.28|0.89
71140673|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|3.92||||0.006|TWO_SIDED|95.0|1.48|10.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||10.36|1.48|0.0060
70866519|NCT02390908|141219380|SUPERIORITY||Beta|1.92||||0.95|TWO_SIDED|95.0|-54.68|58.53||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 1 and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 1 on CD4 Count was estimated against the No-Treatment Control EMR Group.|||58.53|-54.68|0.95
70866520|NCT02390908|141219380|SUPERIORITY||Beta|23.99||||0.61|TWO_SIDED|95.0|-67.54|115.51||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 2 and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 2 on CD4 Count was estimated against the No-Treatment Control EMR Group.|||115.51|-67.54|0.61
70866521|NCT02390908|141219380|SUPERIORITY||Beta|-23.71||||0.48|TWO_SIDED|95.0|-88.82|41.4||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 3's Immediate Delivery Group and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 3 on CD4 Count was estimated against the No-Treatment Control EMR Group.|||41.40|-88.82|0.48
70866522|NCT02390908|141219380|SUPERIORITY||Beta|4.19||||0.88|TWO_SIDED|95.0|-49.76|58.14||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 3 (the Waitlist condition) and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of being in the Waitlist condition (i.e., not receiving the PLUS intervention at Site 3) on log-transformed Viral Load was estimated against the No-Treatment Control EMR Group.|||58.14|-49.76|0.88
70866523|NCT02390908|141219380|SUPERIORITY||Slope|7.67||||0.59|TWO_SIDED|95.0|-19.88|35.21||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in CD4 count across the 3-,6-,9- and 12-month follow-ups for Site 1 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||35.21|-19.88|0.59
71140674|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|1.74||||0.3556|TWO_SIDED|95.0|0.54|5.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.68|0.54|0.3556
71140675|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|3.67||||0.019|TWO_SIDED|95.0|1.24|10.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||10.90|1.24|0.0190
71140676|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|9.9|||<|0.0001|TWO_SIDED|95.0|3.2|30.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||30.68|3.20|<0.0001
71140677|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|14.81|||<|0.0001|TWO_SIDED|95.0|4.67|47.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||47.05|4.67|<0.0001
71140678|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|2.13||||0.1936|TWO_SIDED|95.0|0.68|6.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.67|0.68|0.1936
71140679|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|3.39||||0.0335|TWO_SIDED|95.0|1.1|10.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||10.47|1.10|0.0335
71140680|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|6.18||||0.0009|TWO_SIDED|95.0|2.1|18.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||18.17|2.10|0.0009
71140681|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|0.9||||0.833|TWO_SIDED|95.0|0.34|2.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||2.39|0.34|0.8330
71140682|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|1.56||||0.341|TWO_SIDED|95.0|0.62|3.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.91|0.62|0.3410
71140683|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|3.71||||0.0075|TWO_SIDED|95.0|1.42|9.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||9.69|1.42|0.0075
71140684|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|4.86||||0.002|TWO_SIDED|95.0|1.78|13.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||13.26|1.78|0.0020
71140685|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|0.78||||0.6216|TWO_SIDED|95.0|0.29|2.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||2.10|0.29|0.6216
71140686|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|1.43||||0.4615|TWO_SIDED|95.0|0.55|3.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.71|0.55|0.4615
71140687|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|2.84||||0.0281|TWO_SIDED|95.0|1.12|7.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.19|1.12|0.0281
71140688|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|0.88||||0.8028|TWO_SIDED|95.0|0.33|2.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||2.35|0.33|0.8028
71140689|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|1.21||||0.6846|TWO_SIDED|95.0|0.48|3.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.07|0.48|0.6846
71140690|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|3.31||||0.0149|TWO_SIDED|95.0|1.26|8.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.67|1.26|0.0149
71140691|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|5.64||||0.0009|TWO_SIDED|95.0|2.03|15.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||15.65|2.03|0.0009
71140692|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|0.79||||0.6434|TWO_SIDED|95.0|0.29|2.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||2.15|0.29|0.6434
71140693|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|1.41||||0.4784|TWO_SIDED|95.0|0.54|3.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.69|0.54|0.4784
71140694|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|2.2||||0.0955|TWO_SIDED|95.0|0.87|5.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.55|0.87|0.0955
71140695|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|1.06||||0.9082|TWO_SIDED|95.0|0.4|2.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||2.79|0.40|0.9082
71140696|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|1.25||||0.6478|TWO_SIDED|95.0|0.48|3.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.21|0.48|0.6478
71140697|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|3.65||||0.0104|TWO_SIDED|95.0|1.35|9.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||9.82|1.35|0.0104
71140698|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|6.66||||0.0004|TWO_SIDED|95.0|2.34|18.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||18.94|2.34|0.0004
71140699|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|0.91||||0.856|TWO_SIDED|95.0|0.34|2.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||2.45|0.34|0.8560
71140700|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|1.6||||0.3319|TWO_SIDED|95.0|0.62|4.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.17|0.62|0.3319
71140701|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|2.34||||0.0747|TWO_SIDED|95.0|0.92|5.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.95|0.92|0.0747
71140702|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8986|TWO_SIDED|95.0|0.41|2.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||2.76|0.41|0.8986
71140703|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9712|TWO_SIDED|95.0|0.38|2.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||2.53|0.38|0.9712
70866524|NCT02390908|141219380|SUPERIORITY||Slope|-24.95||||0.24|TWO_SIDED|95.0|-66.78|16.88||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in CD4 count across the 3-,6-,9- and 12-month follow-ups for Site 2 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||16.88|-66.78|0.24
71140704|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|3.31||||0.091|TWO_SIDED|95.0|1.22|8.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.98|1.22|0.0910
71140705|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|5.68||||0.0011|TWO_SIDED|95.0|2.01|16.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||16.06|2.01|0.0011
71140706|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|0.91||||0.8466|TWO_SIDED|95.0|0.35|2.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||2.39|0.35|0.8466
71140707|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|2.03||||0.1409|TWO_SIDED|95.0|0.79|5.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.21|0.79|0.1409
71140708|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1212|TWO_SIDED|95.0|0.82|5.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.25|0.82|0.1212
71140709|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|1.48||||0.4269|TWO_SIDED|95.0|0.56|3.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.88|0.56|0.4269
71140710|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|1.34||||0.5454|TWO_SIDED|95.0|0.52|3.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.49|0.52|0.5454
71140711|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0595|TWO_SIDED|95.0|0.96|7.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.15|0.96|0.0595
71140712|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|4.58||||0.0041|TWO_SIDED|95.0|1.62|12.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||12.98|1.62|0.0041
71140713|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|0.77||||0.6121|TWO_SIDED|95.0|0.28|2.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||2.13|0.28|0.6121
71140714|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|1.8||||0.2329|TWO_SIDED|95.0|0.68|4.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.75|0.68|0.2329
70866525|NCT02390908|141219380|SUPERIORITY||Slope|18.32||||0.15|TWO_SIDED|95.0|-6.63|43.27||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in CD4 count across the 3-,6-,9- and 12-month follow-ups for Site 3 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||43.27|-6.63|0.15
71140715|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|2.28||||0.0891|TWO_SIDED|95.0|0.88|5.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.90|0.88|0.0891
71140716|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|0.55||||0.6857|TWO_SIDED|95.0|0.03|9.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.97|0.03|0.6857
71140717|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|1.56||||0.7291|TWO_SIDED|95.0|0.12|19.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||19.71|0.12|0.7291
71140718|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|0.82||||0.8951|TWO_SIDED|95.0|0.05|14.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||14.41|0.05|0.8951
71140719|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|1.66||||0.6865|TWO_SIDED|95.0|0.14|19.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||19.74|0.14|0.6865
70866526|NCT02390908|141219380|SUPERIORITY||Slope|10.27||||0.33|TWO_SIDED|95.0|-10.2|30.74||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in CD4 count across the 3-,6-,9- and 12-month follow-ups for Waitlist relative to No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||30.74|-10.20|0.33
70866527|NCT02390908|141219380|SUPERIORITY||Slope|6.42||||0.8|TWO_SIDED|95.0|-44.24|57.09||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in CD4 count across the 12-,15-, and 18-month follow-ups for Site 1 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||57.09|-44.24|0.80
70866528|NCT02390908|141219380|SUPERIORITY||Slope|-5.43||||0.89|TWO_SIDED|95.0|-85.47|74.61||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in CD4 count across the 12-,15-, and 18-month follow-ups for Site 2 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||74.61|-85.47|0.89
70866529|NCT02390908|141219380|SUPERIORITY||Slope|1.16||||0.97|TWO_SIDED|95.0|-60.61|62.94||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in log VL across the 12-,15-, and 18-month follow-ups for Site 3 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||62.94|-60.61|0.97
70866530|NCT02390908|141219380|SUPERIORITY||Slope|-38.4||||0.07|TWO_SIDED|95.0|-79.51|2.72||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in log VL across the 12-,15-, and 18-month follow-ups for Waitlist relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||2.72|-79.51|0.07
70866531|NCT02390908|141219381|SUPERIORITY||Beta|-7.87||||0.22|TWO_SIDED|95.0|-20.52|4.78||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 1 and the Waitlist Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 1 on ART Medication Adherence was estimated against Site 3's Waitlist Control Group.|||4.78|-20.52|0.22
70866532|NCT02390908|141219381|SUPERIORITY||Beta|10.29||||0.22|TWO_SIDED|95.0|-6.25|26.82||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 2 and the Waitlist Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 2 on ART Medication Adherence was estimated against Site 3's Waitlist Control Group.|||26.82|-6.25|0.22
70948841|NCT01434680|141398899|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two-sided 95% CI for the ratio of the hSBA GMTs at 28 days following vaccination was within this equivalence interval for each of the two coprimary comparisons, MenC-CRM LIQ and MenC-CRM EMV would be declared equivalent with respect to the immune response to the vaccines.|hSBA GMT ratios|0.82|||<|0.05|TWO_SIDED|95.0|0.67|1.0|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log10 transformed titers and both the limits of 95% CIs||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing MenC-CRM LIQ to MenC-CRM EMV at 28 days after a single vaccination were both within the equivalence interval (0.5, 2.0).||1.00|0.67|<0.05
70948842|NCT01434680|141398899|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two-sided 95% CI for the ratio of the hSBA GMTs at 28 days following vaccination was within this equivalence interval for each of the two coprimary comparisons,MenC-CRM ROS and MenC-CRM EMV would be declared equivalent with respect to the immune response to the vaccines.|hSBA GMT ratios|1.14|||<|0.05|TWO_SIDED|95.0|0.92|1.41|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log10-transformed titers and both the limits of 95% CIs||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing MenC-CRM ROS to MenC-CRM EMV at 28 days after a single vaccination were both within the equivalence interval (0.5, 2.0).||1.41|0.92|<0.05
71140720|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|1.17||||0.9132|TWO_SIDED|95.0|0.07|20.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||20.24|0.07|0.9132
70866533|NCT02390908|141219381|SUPERIORITY||Beta|-0.27||||0.96|TWO_SIDED|95.0|-11.63|11.08||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 3's Immediate Delivery Group and the Waitlist Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.|The main effect of receiving the PLUS intervention immediately at Site 3 on ART Medication Adherence was estimated against Site 3's Waitlist Control Group.|||11.08|-11.63|0.96
70866534|NCT02390908|141219381|SUPERIORITY||Slope|6.34||||0.03|TWO_SIDED|95.0|0.72|11.97||A latent growth curve (LGC) with an intercept and linear slope was specified. The slope estimated here represents linear change in Medication Adherence across the 3-, 6-, 9- and 12-month follow-ups for Site 1 relative to Waitlist Control Group.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.||||11.97|0.72|0.03
70866535|NCT02390908|141219381|SUPERIORITY||Slope|3.35||||0.42|TWO_SIDED|95.0|-4.78|11.47||A latent growth curve (LGC) with an intercept and linear slope was specified. The slope estimated here represents linear change in Medication Adherence across the 3-, 6-, 9- and 12-month follow-ups for Site 2 relative to Waitlist Control Group.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.||||11.47|-4.78|0.42
70866536|NCT02390908|141219381|SUPERIORITY||Slope|0.34||||0.91|TWO_SIDED|95.0|-5.85|6.54||A latent growth curve (LGC) with an intercept and linear slope was specified. The slope estimated here represents linear change in Medication Adherence across 3-,6-,9- and 12-month follow-ups for Site 3 (Immediate) relative to Waitlist Control Group.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.||||6.54|-5.85|0.91
70866537|NCT02390908|141219382|SUPERIORITY||Beta|3.19||||0.02|TWO_SIDED|95.0|0.61|5.78||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 1 and the Waitlist Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 1 on Alcohol Use severity (AUDIT) was estimated against Site 3's Waitlist Control Group.|||5.78|0.61|0.02
70866538|NCT02390908|141219382|SUPERIORITY||Beta|-0.86||||0.63|TWO_SIDED|95.0|-4.33|2.61||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 2 and the Waitlist Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 2 on Alcohol Use severity (AUDIT) was estimated against Site 3's Waitlist Control Group.|||2.61|-4.33|0.63
70866539|NCT02390908|141219382|SUPERIORITY||Beta|4.17||||0.02|TWO_SIDED|95.0|0.8|7.54||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 3's Immediate Delivery Group and the Waitlist Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.|The main effect of receiving the PLUS intervention immediately at Site 3 on Alcohol Use severity (AUDIT) was estimated against Site 3's Waitlist Control Group.|||7.54|0.80|0.02
70866540|NCT02390908|141219382|SUPERIORITY||Slope|-0.4||||0.46|TWO_SIDED|95.0|-1.47|0.67||A latent growth curve (LGC) with an intercept and linear slope was specified. The slope estimated here represents linear change in AUDIT across the 3-, 6-, 9- and 12-month follow-ups for Site 1 relative to that for the Waitlist Control Group.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.||||0.67|-1.47|0.46
70866541|NCT02390908|141219382|SUPERIORITY||Slope|-0.29||||0.5|TWO_SIDED|95.0|-1.12|0.55||A latent growth curve (LGC) with an intercept and linear slope was specified. The slope estimated here represents linear change in AUDIT across the 3-, 6-, 9- and 12-month follow-ups for Site 2 relative to that for the Waitlist Control Group.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.||||0.55|-1.12|0.50
70866542|NCT02390908|141219382|SUPERIORITY||Slope|-0.35||||0.43|TWO_SIDED|95.0|-1.23|0.52||A latent growth curve (LGC) with an intercept and linear slope was specified. The slope estimated here represents linear change in AUDIT across the 3-, 6-, 9- and 12-month follow-ups for Site 3 (Immediate) relative to Waitlist Control Group.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.||||0.52|-1.23|0.43
70866543|NCT01781975|141219383|SUPERIORITY||ANCOVA|0.0616|STANDARD_ERROR_OF_MEAN|0.0364||0.048|TWO_SIDED|90.0|0.00176|0.121|||ANCOVA|||||0.121|0.00176|0.048
70866544|NCT03881670|141219419|OTHER|Friedman test||||||0.0023|||||||Friedman Test|||Change in ratings over time||||0.0023
70866545|NCT03881670|141219419|OTHER|Friedman test||||||0.4679|||||||Friedman Test|||change in ratings over time||||0.4679
70866546|NCT00914485|141219421|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||t-test, 1 sided|||Increase in mean, post-intervention versus baseline, across 18 providers and 369 patients.||||.03
70866547|NCT04889222|141219423|EQUIVALENCE|A TOST procedure using the Wilcoxon Rank Sum Test was used to test the hypothesis that the median biases of the INVSENSOR00050 sensor from two pigmentation subgroups (Light and Dark) were equivalent within ± 1 %SpO2. The TOST procedure provides a p-value indicating whether the two measures are equivalent if the p-value is less than 0.05.||||||0.00097||||||The a priori threshold for p-value was 0.05.|Two One Sided Tests (TOST)|||||||0.00097
70866548|NCT04889222|141219424|EQUIVALENCE|A TOST procedure using the Wilcoxon Rank Sum Test was used to test the hypothesis that the median biases of the RD SET SpO2 sensor from two pigmentation subgroups (Light and Dark) were equivalent within ± 1 %SpO2. The TOST procedure provides a p-value indicating whether the two measures are equivalent if the p-value is less than 0.05.||||||0||||||The a priori threshold for p-value was 0.05.|Two One-Sided Tests (TOST)|||||||0.00000
70866549|NCT00702689|141219435|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011|||||||Paired t-test|||||||.011
70866550|NCT00702689|141219437|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47|||||||t-test, 2 sided|||||||.47
70866551|NCT00702689|141219438|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||t-test, 2 sided|||||||.29
70866552|NCT01761175|141219468|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Chi-squared|||||||<0.01
70866553|NCT01761175|141219469|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Chi-squared|||||||<0.01
70866554|NCT01761175|141219470|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Log Rank|||||||<0.01
70866555|NCT01761175|141219471|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Log Rank|||||||<0.01
70866556|NCT01761175|141219472|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||||||0.02
70866557|NCT01761175|141219473|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71140721|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|1.38||||0.7982|TWO_SIDED|95.0|0.12|16.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||16.59|0.12|0.7982
71140722|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|1.17||||0.9029|TWO_SIDED|95.0|0.09|15.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||15.57|0.09|0.9029
71140723|NCT03192176|141778527|SUPERIORITY||Odds Ratio (OR)|0.69||||0.7971|TWO_SIDED|95.0|0.04|11.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||11.94|0.04|0.7971
71140724|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|0.67||||0.7899|TWO_SIDED|95.0|0.04|12.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||12.34|0.04|0.7899
71140725|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|0.86||||0.9186|TWO_SIDED|95.0|0.05|14.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||14.73|0.05|0.9186
70866558|NCT01761175|141219474|SUPERIORITY_OR_OTHER|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||||||0.34
70866559|NCT01903031|141219506|OTHER||||||<|0.001||||||No adjustments for multiple comparisons were made. Statistical significance was declared if p\<0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference in concentrations of Etonogestrel on day 21 between the control arm (NuvaRing and no ART) and NuvaRing with EFV plus ≥2 NRTIs.||||<0.001
70866560|NCT01903031|141219506|OTHER||||||<|0.001||||||No adjustments for multiple comparisons were made. Statistical significance was declared if p\<0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference in concentrations of Etonogestrel on day 21 between the control arm (NuvaRing and no ART) and NuvaRing with ATV/r plus TDF and ≥1 NRTIs.||||<0.001
70866561|NCT01903031|141219507|OTHER||||||<|0.001||||||No adjustments for multiple comparisons were made. Statistical significance was declared if p\<0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference in concentrations of Ethinyl Estradiol on day 21 between the control arm (NuvaRing and no ART) and NuvaRing with EFV plus ≥2 NRTIs.||||<0.001
70866562|NCT01903031|141219507|OTHER|||||||0.004||||||No adjustments for multiple comparisons were made. Statistical significance was declared if p\<0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference in concentrations of Ethinyl Estradiol on day 21 between the control arm (NuvaRing and no ART) and NuvaRing with ATV/r plus TDF and ≥1 NRTIs.||||0.004
70866563|NCT03540030|141219527|OTHER|||||||0.297|||||||Wilcoxon (Mann-Whitney)|||||||.297
70866564|NCT03540030|141219528|OTHER|||||||0.005||||||At the 6 hour time point|Wilcoxon (Mann-Whitney)|||||||0.005
70866565|NCT03540030|141219528|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||At the 12 hour time point||||0.005
70948843|NCT01434680|141398900|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two-sided 95% CI for the ratio of the hSBA GMTs at 28 days following vaccination was within this equivalence interval, the two vaccine groups would be declared equivalent with respect to the immune response to the vaccines.|hSBA GMT ratios|0.72|||<|0.05|TWO_SIDED|95.0|0.58|0.89|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log10-transformed titers and both the limits of 95% CIs||The secondary objective was to be assessed only if both primary objectives were met. Because of this, no adjustment for multiplicity was required. MenC-CRM liquid would be declared equivalent to MenC-CRM ROS if the two-sided 95% CI for the ratio of the hSBA GMTs at approximately 28 days following vaccination was within the equivalence interval (0.5, 2.0).||0.89|0.58|<0.05
70948844|NCT01952847|141398916|OTHER|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
70866566|NCT03540030|141219529|OTHER|||||||0.0801|||||||Fisher Exact|||||||0.0801
70866567|NCT03540030|141219530|OTHER|||||||0.0154|||||||Chi-squared|||||||0.0154
70948845|NCT01952847|141398917|OTHER|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
70866568|NCT03540030|141219531|OTHER|||||||0.2139|||||||Fisher Exact|||||||0.2139
70866569|NCT03540030|141219533|OTHER||||||>|0.99|||||||Fisher Exact|||||||>.99
70866570|NCT03540030|141219534|OTHER|||||||0.9669|||||||Wilcoxon (Mann-Whitney)|||||||0.9669
70866571|NCT03540030|141219535|OTHER|||||||0.9208|||||||Wilcoxon (Mann-Whitney)|||||||.9208
70866572|NCT03540030|141219536|OTHER|||||||0.6481|||||||Wilcoxon (Mann-Whitney)|||For PCS only||||0.6481
70866573|NCT03540030|141219536|OTHER|||||||0.3911|||||||Wilcoxon (Mann-Whitney)|||For MCS only||||0.3911
70866574|NCT03540030|141219537|OTHER||||||>|0.99|||||||Fisher Exact|||||||>.99
70866575|NCT03540030|141219538|OTHER|||||||0.3177|||||||Fisher Exact|||||||0.3177
70866576|NCT03540030|141219539|OTHER||||||>|0.99|||||||Fisher Exact|||||||>.99
70948846|NCT01952847|141398920|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
70948847|NCT01952847|141398921|SUPERIORITY|||||||0.59|||||||Fisher Exact|||||||0.59
70866577|NCT03540030|141219540|OTHER|||||||0.2349|||||||Fisher Exact|||||||0.2349
70866578|NCT03540030|141219541|OTHER|||||||0.7892|||||||Wilcoxon (Mann-Whitney)|||||||0.7892
70866579|NCT03540030|141219542|OTHER|||||||0.2023|||||||Wilcoxon (Mann-Whitney)|||For PCS only||||0.2023
70866580|NCT03540030|141219542|OTHER|||||||0.2486|||||||Wilcoxon (Mann-Whitney)|||For MCS only||||0.2486
70866581|NCT03329508|141219543|SUPERIORITY||Differences of Least Square Means|-2.66|STANDARD_ERROR_OF_MEAN|0.85||0.0018|TWO_SIDED|95.0|-4.33|-1.0|||MMRM|||||-1.0|-4.33|0.0018
70866582|NCT03329508|141219543|SUPERIORITY||Mean Difference (Net)|-3.3|STANDARD_ERROR_OF_MEAN|0.85||0.0001|TWO_SIDED|95.0|-4.96|-1.63|||MMRM|||||-1.63|-4.96|0.0001
70866583|NCT03329508|141219544|SUPERIORITY||Mean Difference (Net)|-2.66|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-3.5|-1.81|||MMRM|||||-1.81|-3.50|<0.0001
70866584|NCT03329508|141219544|SUPERIORITY||Mean Difference (Final Values)|-2.66|STANDARD_ERROR_OF_MEAN|0.43|<|0.05|TWO_SIDED|95.0|-3.5|-1.81|||MMRM|||||-1.81|-3.50|<0.05
70866585|NCT03329508|141219545|SUPERIORITY||Mean Difference (Net)|-1.52|STANDARD_ERROR_OF_MEAN|0.67||0.0231|TWO_SIDED|95.0|-2.84|-0.21|||MMRM|||||-0.21|-2.84|0.0231
70866586|NCT03329508|141219545|SUPERIORITY||Mean Difference (Net)|-1.75|STANDARD_ERROR_OF_MEAN|0.67||0.0092|TWO_SIDED|95.0|-3.06|-0.43|||MMRM|||||-0.43|-3.06|0.0092
70866587|NCT03329508|141219546|SUPERIORITY||Mean Difference (Net)|-1.17|STANDARD_ERROR_OF_MEAN|0.31||0.0001|TWO_SIDED|95.0|-1.77|-0.57|||MMRM|||||-0.57|-1.77|0.0001
70866588|NCT03329508|141219546|SUPERIORITY||Mean Difference (Net)|-1.52|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-2.13|-0.92|||MMRM|||||-0.92|-2.13|<0.0001
70866589|NCT03329508|141219547|SUPERIORITY||Mean Difference (Net)|-2.18|STANDARD_ERROR_OF_MEAN|1.54||0.1589|TWO_SIDED|95.0|-5.21|0.85|||MMRM|||||0.85|-5.21|0.1589
71140726|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|2.19||||0.5303|TWO_SIDED|95.0|0.19|25.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||25.46|0.19|0.5303
71140727|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|5.85||||0.1149|TWO_SIDED|95.0|0.65|52.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||52.66|0.65|0.1149
71140728|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|9.07||||0.0442|TWO_SIDED|95.0|1.06|77.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||77.71|1.06|0.0442
71140729|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|3.53||||0.2851|TWO_SIDED|95.0|0.35|35.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||35.68|0.35|0.2851
71140730|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|4.22||||0.2073|TWO_SIDED|95.0|0.45|39.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||39.48|0.45|0.2073
71140731|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|3.68||||0.27|TWO_SIDED|95.0|0.36|37.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||37.16|0.36|0.2700
71140732|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|3.41||||0.2982|TWO_SIDED|95.0|0.34|34.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||34.27|0.34|0.2982
71140733|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|12.3||||0.0204|TWO_SIDED|95.0|1.47|102.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||102.6|1.47|0.0204
71140734|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|11.1||||0.027|TWO_SIDED|95.0|1.31|93.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||93.74|1.31|0.0270
71140735|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|2.22||||0.5224|TWO_SIDED|95.0|0.19|25.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||25.68|0.19|0.5224
71140736|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|4.92||||0.1635|TWO_SIDED|95.0|0.52|46.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||46.35|0.52|0.1635
71140737|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|10.97||||0.0266|TWO_SIDED|95.0|1.32|91.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||91.15|1.32|0.0266
71140738|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|2.69||||0.4299|TWO_SIDED|95.0|0.23|31.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||31.21|0.23|0.4299
70866590|NCT00569270|141219552|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||a priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Peak FEV1 of tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.027
71140739|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|4.87||||0.1667|TWO_SIDED|95.0|0.52|45.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||45.84|0.52|0.1667
71140740|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|8.11||||0.0592|TWO_SIDED|95.0|0.92|71.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||71.35|0.92|0.0592
71140741|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|18.28||||0.007|TWO_SIDED|95.0|2.21|151.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||151.2|2.21|0.0070
71140742|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|3.79||||0.2594|TWO_SIDED|95.0|0.37|38.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||38.32|0.37|0.2594
70948848|NCT01952847|141398922|SUPERIORITY|||||||0.73|||||||Fisher Exact|||||||0.73
70948849|NCT01952847|141398923|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
70948850|NCT01952847|141398924|OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
70948851|NCT01952847|141398925|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
70948852|NCT01952847|141398926|SUPERIORITY|||||||0.57|||||||Log Rank|||||||0.57
70948853|NCT01952847|141398930|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||||||0.83
70948854|NCT01952847|141398931|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
70948855|NCT00121667|141398973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.92|-0.53||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-0.53|-0.92|<.0001
70948856|NCT00121667|141398973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-1.02|-0.63||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-0.63|-1.02|<.0001
70948857|NCT00121667|141398973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.91|-0.52||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF) .Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-0.52|-0.91|<.0001
70948858|NCT00121667|141398974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.55|STANDARD_ERROR_OF_MEAN|3.56|<|0.0001|TWO_SIDED|95.0|-22.55|-8.55||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-8.55|-22.55|<.0001
70948859|NCT00121667|141398974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.28|STANDARD_ERROR_OF_MEAN|3.57|<|0.0001|TWO_SIDED|95.0|-30.29|-16.27||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF) .Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-16.27|-30.29|<.0001
70948860|NCT00121667|141398974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.74|STANDARD_ERROR_OF_MEAN|3.6|<|0.0001|TWO_SIDED|95.0|-28.81|-14.68||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF) .Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-14.68|-28.81|<.0001
70948861|NCT00121667|141398975|SUPERIORITY_OR_OTHER||Difference in Proportions|20.5|||<|0.0001|TWO_SIDED|95.0|10.6|30.5||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.||||30.5|10.6|<.0001
70948862|NCT00121667|141398975|SUPERIORITY_OR_OTHER||Difference in Proportions|27.0|||<|0.0001|TWO_SIDED|95.0|17.0|36.7||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.||||36.7|17.0|<.0001
70948863|NCT00121667|141398975|SUPERIORITY_OR_OTHER||Difference in Proportions|27.9|||<|0.0001|TWO_SIDED|95.0|17.7|37.7||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.||||37.7|17.7|<.0001
70948864|NCT00121667|141398976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5599.0|STANDARD_ERROR_OF_MEAN|1168.2|<|0.0001|TWO_SIDED|95.0|-7894.0|-3305.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-3305|-7894|<.0001
70948865|NCT00121667|141398976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6294.0|STANDARD_ERROR_OF_MEAN|1176.8|<|0.0001|TWO_SIDED|95.0|-8606.0|-3983.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-3983|-8606|<.0001
70948866|NCT00121667|141398976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4845.0|STANDARD_ERROR_OF_MEAN|1175.1|<|0.0001|TWO_SIDED|95.0|-7153.0|-2537.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-2537|-7153|<.0001
70948867|NCT01453023|141399008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2|||||TWO_SIDED|95.0|-8.8|0.4|||||Day 1 HR. The estimated value represents the treatment difference: FF/VI 100/25 µg minus FF 100 µg.|||0.4|-8.8|
70948868|NCT01453023|141399008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7|||||TWO_SIDED|95.0|-1.1|8.5|||||Day 14 HR. The estimated value represents the treatment difference: FF/VI 100/25 µg minus FF 100 µg.|||8.5|-1.1|
71140743|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|8.14||||0.0589|TWO_SIDED|95.0|0.92|71.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||71.67|0.92|0.0589
71140744|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|10.08||||0.0338|TWO_SIDED|95.0|1.19|85.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||85.20|1.19|0.0338
71140745|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|0.76||||0.7756|TWO_SIDED|95.0|0.12|4.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.88|0.12|0.7756
71140746|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9246|TWO_SIDED|95.0|0.2|5.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.74|0.20|0.9246
71140747|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|5.42||||0.0177|TWO_SIDED|95.0|1.34|21.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||21.93|1.34|0.0177
71140748|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|5.38||||0.0178|TWO_SIDED|95.0|1.34|21.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||21.65|1.34|0.0178
71140749|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|1.17||||0.8564|TWO_SIDED|95.0|0.22|6.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.20|0.22|0.8564
71140750|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|2.52||||0.2202|TWO_SIDED|95.0|0.58|11.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||11.00|0.58|0.2202
71140751|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|2.37||||0.2498|TWO_SIDED|95.0|0.55|10.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||10.25|0.55|0.2498
71140752|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|8.22||||0.0576|TWO_SIDED|95.0|0.93|72.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||72.29|0.93|0.0576
71140753|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|3.34||||0.3065|TWO_SIDED|95.0|0.33|33.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||33.59|0.33|0.3065
71140754|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|19.9||||0.0056|TWO_SIDED|95.0|2.4|165.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||165.1|2.40|0.0056
71140755|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|25.05||||0.0027|TWO_SIDED|95.0|3.05|205.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||205.5|3.05|0.0027
70948869|NCT01453023|141399009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|-4.4|6.7|||||Day 1 QTcF. The estimated value represents the treatment difference: FF/VI 100/25 µg minus FF 100 µg.|||6.7|-4.4|
70948870|NCT01453023|141399009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-6.0|5.5|||||Day 14 QTcF. The estimated value represents the treatment difference: FF/VI 100/25 µg minus FF 100 µg.|||5.5|-6.0|
71140756|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|3.61||||0.2762|TWO_SIDED|95.0|0.36|36.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||36.51|0.36|0.2762
71140757|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|6.93||||0.0851|TWO_SIDED|95.0|0.77|62.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||62.69|0.77|0.0851
70948871|NCT01512797|141399057|OTHER|||||||0.028||||||P-value refers to paired t-test comparing pre-intervention and post-intervention timepoints in Sitagliptin group.|t-test, 2 sided|||Power analysis. Based on the effect of DPP-4 inhibitors in non-operated subjects with type 2 diabetes, showing a significant decrease in 120' post-prandial glucose by 1.67 mmol/L ± 0.98 mmol/L after a MMT, we estimated that a sample size of 16 subjects per group will show post-prandial glucose differences between placebo and sitagliptin group with α = 0.05 for a power \> 90%.||||0.028
70948872|NCT01080300|141399070|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|0.311||0.0003|TWO_SIDED|95.0|-2.31|-1.09||P-value for the test of difference of the least square mean change from baseline between Gabapentin ER 1800 mg and placebo group is based on the F-test of Type III analysis.|Based on Van Eltereen|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Frequency at Week 4:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate to severe hot flashes at Week 4."||-1.09|-2.31|0.0003
71140758|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|17.02||||0.0081|TWO_SIDED|95.0|2.09|138.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||138.7|2.09|0.0081
71140759|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|6.37||||0.0995|TWO_SIDED|95.0|0.7|57.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||57.62|0.70|0.0995
71140760|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|5.76||||0.1184|TWO_SIDED|95.0|0.64|51.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||51.80|0.64|0.1184
71140761|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|26.54||||0.0023|TWO_SIDED|95.0|3.23|218.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||218.3|3.23|0.0023
71140762|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|19.09||||0.0062|TWO_SIDED|95.0|2.31|157.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||157.9|2.31|0.0062
71140763|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|7.49||||0.0695|TWO_SIDED|95.0|0.85|65.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||65.87|0.85|0.0695
71140764|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|8.64||||0.052|TWO_SIDED|95.0|0.98|75.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||75.98|0.98|0.0520
71140765|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|22.3||||0.0036|TWO_SIDED|95.0|2.75|180.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||180.6|2.75|0.0036
71140766|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|4.66||||0.0676|TWO_SIDED|95.0|0.89|24.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||24.23|0.89|0.0676
71140767|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|4.14||||0.0903|TWO_SIDED|95.0|0.8|21.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||21.38|0.80|0.0903
71140768|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|15.46||||0.0007|TWO_SIDED|95.0|3.18|75.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||75.14|3.18|0.0007
71140769|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|10.94||||0.0032|TWO_SIDED|95.0|2.22|53.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||53.77|2.22|0.0032
71140770|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|3.04||||0.2031|TWO_SIDED|95.0|0.55|16.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||16.85|0.55|0.2031
70866591|NCT00569270|141219553|SUPERIORITY_OR_OTHER||Spearman rho|0.19||||0.96||95.0||||A priori threshold for statistical significance: p=0.05|Spearman rho|||Correlation between improved lung function after tiotropium and extent of lung CT scored emphysema with respect to ratio functional residual capacity divided by total lung capacity. Specifically, correlation of tiotropium induced bronchodilation and extent of lung ct scored emphysema; measure includes change in FEV1 post tiotropium||||0.96
71140771|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|4.13||||0.0972|TWO_SIDED|95.0|0.77|22.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||22.10|0.77|0.0972
70866592|NCT00569270|141219554|SUPERIORITY_OR_OTHER|||||||0.318||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Peak FRC in tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.318
71140772|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|11.04||||0.0027|TWO_SIDED|95.0|2.3|53.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||53.06|2.30|0.0027
71140773|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|3.06||||0.1306|TWO_SIDED|95.0|0.72|13.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.02|0.72|0.1306
71140774|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|4.83||||0.0248|TWO_SIDED|95.0|1.22|19.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||19.10|1.22|0.0248
71140775|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|7.14||||0.0054|TWO_SIDED|95.0|1.79|28.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||28.53|1.79|0.0054
71140776|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|10.01||||0.001|TWO_SIDED|95.0|2.55|39.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||39.36|2.55|0.0010
71140777|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|1.21||||0.8271|TWO_SIDED|95.0|0.23|6.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.45|0.23|0.8271
71140778|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|3.27||||0.1089|TWO_SIDED|95.0|0.77|13.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.95|0.77|0.1089
71140779|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|5.58||||0.0138|TWO_SIDED|95.0|1.42|21.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||21.93|1.42|0.0138
71140780|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|2.4||||0.1987|TWO_SIDED|95.0|0.63|9.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||9.15|0.63|0.1987
71140781|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|1.8||||0.3984|TWO_SIDED|95.0|0.46|7.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||7.02|0.46|0.3984
70948873|NCT01080300|141399070|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.14|STANDARD_ERROR_OF_MEAN|0.335||0.1|TWO_SIDED|95.0|-1.8|-0.48||P-value for the test of difference of the least square mean change from baseline between Gabapentin ER 1800 mg and placebo group is based on the F-test of Type III analysis.|Based on Van Elteren|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Frequency at Week 12:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate to severe hot flashes at Week 12."||-0.48|-1.80|0.1000
71140782|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|3.92||||0.0402|TWO_SIDED|95.0|1.06|14.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||14.45|1.06|0.0402
71140783|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|8.05||||0.001|TWO_SIDED|95.0|2.32|27.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||27.95|2.32|0.0010
71140784|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|0.84||||0.8287|TWO_SIDED|95.0|0.17|4.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.08|0.17|0.8287
71140785|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|2.93||||0.1083|TWO_SIDED|95.0|0.79|10.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.92|0.79|0.1083
71140786|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|6.03||||0.0043|TWO_SIDED|95.0|1.76|20.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||20.66|1.76|0.0043
71140787|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|3.23||||0.1126|TWO_SIDED|95.0|0.76|13.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||13.79|0.76|0.1126
71140788|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|2.9||||0.1479|TWO_SIDED|95.0|0.69|12.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||12.30|0.69|0.1479
71140789|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|10.49||||0.001|TWO_SIDED|95.0|2.59|42.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||42.46|2.59|0.0010
71140790|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|13.01||||0.0002|TWO_SIDED|95.0|3.31|51.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||51.14|3.31|0.0002
71140791|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|2.91||||0.1483|TWO_SIDED|95.0|0.68|12.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||12.41|0.68|0.1483
71140792|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|4.03||||0.0557|TWO_SIDED|95.0|0.97|16.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||16.84|0.97|0.0557
71140793|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|6.47||||0.0072|TWO_SIDED|95.0|1.66|25.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||25.28|1.66|0.0072
71140794|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9715|TWO_SIDED|95.0|0.32|3.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.24|0.32|0.9715
71140795|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|1.49||||0.472|TWO_SIDED|95.0|0.5|4.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.39|0.50|0.4720
70866593|NCT00569270|141219555|SUPERIORITY_OR_OTHER|||||||0.078||95.0||||Statistical significance was p \< 0.05|Mixed Models Analysis|||Mean difference of Peak FVC of tiotropium minus placebo.29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.078
70948874|NCT01080300|141399071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001|TWO_SIDED|95.0|-0.31|-0.1||P-value for the test of difference of the least square mean change from baseline between Gabapentin ER 1800 mg and placebo group is based on the F-test of Type III analysis.|Based on Van Elteren|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Severity Score at Week 4:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate to severe hot flashes at Week 4."||-0.10|-0.31|<0.0001
71140796|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|2.35||||0.1262|TWO_SIDED|95.0|0.79|7.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.05|0.79|0.1262
71140797|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|3.07||||0.0396|TWO_SIDED|95.0|1.05|8.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.92|1.05|0.0396
71140798|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|0.66||||0.5137|TWO_SIDED|95.0|0.19|2.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||2.29|0.19|0.5137
71140799|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|2.25||||0.137|TWO_SIDED|95.0|0.77|6.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.58|0.77|0.1370
71140800|NCT03192176|141778528|SUPERIORITY||Odds Ratio (OR)|1.39||||0.5526|TWO_SIDED|95.0|0.47|4.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.07|0.47|0.5526
71140801|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|5.75||||0.0012|TWO_SIDED|95.0|1.99|16.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.62|1.99|0.0012
71140802|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|8.86|||<|0.0001|TWO_SIDED|95.0|3.06|25.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||25.68|3.06|<0.0001
71140803|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|11.55|||<|0.0001|TWO_SIDED|95.0|3.94|33.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||33.85|3.94|<0.0001
71140804|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|13.55|||<|0.0001|TWO_SIDED|95.0|4.55|40.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||40.38|4.55|<0.0001
71140805|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0555|TWO_SIDED|95.0|0.98|8.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||8.61|0.98|0.0555
71140806|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|7.98||||0.0001|TWO_SIDED|95.0|2.75|23.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||23.18|2.75|0.0001
71140807|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|8.07||||0.0001|TWO_SIDED|95.0|2.81|23.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||23.19|2.81|0.0001
71140808|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|4.55||||0.0012|TWO_SIDED|95.0|1.82|11.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||11.39|1.82|0.0012
71140809|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|5.25||||0.0005|TWO_SIDED|95.0|2.06|13.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||13.43|2.06|0.0005
70948875|NCT01080300|141399071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.072||0.0004|TWO_SIDED|95.0|-0.33|-0.04||P-value for the test of difference of the least square mean change from baseline between Gabapentin ER 1800 mg and placebo group is based on the F-test of Type III analysis.|Based on Van Elteren|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Severity Score at Week 12:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate to severe hot flashes at Week 12."||-0.04|-0.33|0.0004
70948876|NCT01080300|141399072|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.08|STANDARD_ERROR_OF_MEAN|0.453||0.151|TWO_SIDED|95.0|-1.98|-0.19|||Based on Van Elteren|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Frequency at Week 24:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in observed average daily number of moderate to severe hot flashes at Week 24."||-0.19|-1.98|0.1510
71140810|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|5.62||||0.0003|TWO_SIDED|95.0|2.2|14.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||14.39|2.20|0.0003
71140811|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|8.42|||<|0.0001|TWO_SIDED|95.0|2.99|23.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||23.74|2.99|<0.0001
71140812|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|2.74||||0.0277|TWO_SIDED|95.0|1.12|6.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.70|1.12|0.0277
71140813|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|4.15||||0.0022|TWO_SIDED|95.0|1.66|10.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.32|1.66|0.0022
71140814|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|3.06||||0.0314|TWO_SIDED|95.0|1.26|7.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.41|1.26|0.0314
71140815|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|3.92||||0.0041|TWO_SIDED|95.0|1.54|9.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.97|1.54|0.0041
71140816|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|4.19||||0.0028|TWO_SIDED|95.0|1.64|10.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.74|1.64|0.0028
71140817|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|4.96||||0.0011|TWO_SIDED|95.0|1.9|12.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||12.98|1.90|0.0011
71140818|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|8.79||||0.0001|TWO_SIDED|95.0|2.86|26.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||26.99|2.86|0.0001
71140819|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|4.09||||0.0036|TWO_SIDED|95.0|1.59|10.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.57|1.59|0.0036
71140820|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|4.52||||0.0018|TWO_SIDED|95.0|1.75|11.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||11.67|1.75|0.0018
71140821|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|2.76||||0.0243|TWO_SIDED|95.0|1.14|6.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.68|1.14|0.0243
71140822|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|2.33||||0.077|TWO_SIDED|95.0|0.91|5.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.96|0.91|0.0770
71140823|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|2.61||||0.0451|TWO_SIDED|95.0|1.02|6.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.69|1.02|0.0451
71140824|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|3.36||||0.0165|TWO_SIDED|95.0|1.25|9.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||9.04|1.25|0.0165
70948877|NCT01080300|141399073|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.0004|TWO_SIDED|95.0|-0.44|0.0|||Van Elteren|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Severity Score at Week 24:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in observed average daily severity score of moderate to severe hot flashes at Week 24."||-0.00|-0.44|0.0004
70948878|NCT01080300|141399074|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|13.6||||0.0008|TWO_SIDED|95.0|5.7|21.6|||2-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|"Proportion of patients who were categorized as very much or much improved in PGIC at Week 12.~Null Hypotheses: no treatment differences, relative to placebo in the proportion of patients who were categorized as very much or much improved in the PGIC score at week 12.."||21.6|5.7|0.0008
71140825|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0037|TWO_SIDED|95.0|1.72|16.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||16.23|1.72|0.0037
71140826|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|2.29||||0.0812|TWO_SIDED|95.0|0.9|5.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.82|0.90|0.0812
71140827|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|2.46||||0.0577|TWO_SIDED|95.0|0.97|6.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.22|0.97|0.0577
71140828|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0706|TWO_SIDED|95.0|0.93|5.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.85|0.93|0.0706
71140829|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0404|TWO_SIDED|95.0|1.04|7.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.00|1.04|0.0404
71140830|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|4.3||||0.0054|TWO_SIDED|95.0|1.54|11.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||11.99|1.54|0.0054
70866594|NCT00569270|141219556|SUPERIORITY_OR_OTHER||Spearman rho|-0.26||||0.4||95.0|||||Spearman rho|||Correlation between improved lung function after tiotropium and extent of lung CT scored emphysema with respect to ratio functional residual capacity divided by total lung capacity. Specifically, correlation of tiotropium induced bronchodilation and extent of lung ct scored emphysema (19 patients); measures include change in IC at trough tiotropium.||||0.4
71140831|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|3.37||||0.0186|TWO_SIDED|95.0|1.22|9.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||9.27|1.22|0.0186
71140832|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|6.58||||0.0023|TWO_SIDED|95.0|1.96|22.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||22.14|1.96|0.0023
71140833|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|3.63||||0.0118|TWO_SIDED|95.0|1.33|9.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||9.93|1.33|0.0118
71140834|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|5.57||||0.002|TWO_SIDED|95.0|1.88|16.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||16.53|1.88|0.0020
71140835|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|2.71||||0.043|TWO_SIDED|95.0|1.03|7.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.14|1.03|0.0430
71140836|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|1.81||||0.2197|TWO_SIDED|95.0|0.7|4.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||4.66|0.70|0.2197
71140837|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1341|TWO_SIDED|95.0|0.8|5.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.42|0.80|0.1341
71140838|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|3.69||||0.0196|TWO_SIDED|95.0|1.23|11.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||11.05|1.23|0.0196
71140839|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|4.79||||0.0121|TWO_SIDED|95.0|1.41|16.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||16.26|1.41|0.0121
70948879|NCT01080300|141399074|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|13.4||||0.0009|TWO_SIDED|95.0|5.5|21.3|||2-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|"Proportion of patients who were categorized as very much or much improved in PGIC at Week 24."||21.3|5.5|0.0009
71140840|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|2.06||||0.1511|TWO_SIDED|95.0|0.77|5.56||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.56|0.77|0.1511
71140841|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|4.94||||0.0068|TWO_SIDED|95.0|1.55|15.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||15.68|1.55|0.0068
71140842|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|2.49||||0.0741|TWO_SIDED|95.0|0.91|6.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.79|0.91|0.0741
71140843|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|1.7||||0.2772|TWO_SIDED|95.0|0.65|4.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.43|0.65|0.2772
71140844|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|2.55||||0.0705|TWO_SIDED|95.0|0.92|7.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.02|0.92|0.0705
71140845|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|3.88||||0.022|TWO_SIDED|95.0|1.22|12.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||12.39|1.22|0.0220
71140846|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|4.33||||0.0196|TWO_SIDED|95.0|1.27|14.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||14.82|1.27|0.0196
71140847|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|3.09||||0.0433|TWO_SIDED|95.0|1.03|9.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.24|1.03|0.0433
71140848|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|3.15||||0.0355|TWO_SIDED|95.0|1.08|9.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.20|1.08|0.0355
71140849|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|1.63||||0.3238|TWO_SIDED|95.0|0.62|4.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.28|0.62|0.3238
71140850|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|1.68||||0.3208|TWO_SIDED|95.0|0.6|4.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.68|0.60|0.3208
71140851|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|1.9||||0.2281|TWO_SIDED|95.0|0.67|5.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.40|0.67|0.2281
71140852|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|3.18||||0.0566|TWO_SIDED|95.0|0.97|10.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||10.46|0.97|0.0566
71140853|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|2.39||||0.1491|TWO_SIDED|95.0|0.73|7.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.78|0.73|0.1491
71140854|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|2.32||||0.1477|TWO_SIDED|95.0|0.74|7.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.23|0.74|0.1477
71140855|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|3.24||||0.0532|TWO_SIDED|95.0|0.98|10.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||10.64|0.98|0.0532
71140856|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|2.22||||0.1616|TWO_SIDED|95.0|0.73|6.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.76|0.73|0.1616
70948880|NCT01080300|141399075|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|16.4|||<|0.0001|TWO_SIDED|95.0|8.4|24.3|||2-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|"Proportion of patients who were categorized as very much or much improved in CGIC at Week 12.~Null Hypotheses: no treatment differences, relative to placebo in the proportion of patients who were categorized as very much or much improved in the CGIC score at week 12."||24.3|8.4|<0.0001
70948881|NCT01080300|141399075|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.0||||0.007|TWO_SIDED|95.0|3.0|19.0|||2-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|Week 24||19.0|3.0|0.0070
71140857|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|1.5||||0.432|TWO_SIDED|95.0|0.55|4.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.11|0.55|0.4320
71140858|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|1.9||||0.2231|TWO_SIDED|95.0|0.68|5.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.35|0.68|0.2231
71140859|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|3.88||||0.0347|TWO_SIDED|95.0|1.1|13.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.64|1.10|0.0347
71140860|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|4.59||||0.0291|TWO_SIDED|95.0|1.17|18.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||18.07|1.17|0.0291
71140861|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|1.82||||0.2805|TWO_SIDED|95.0|0.61|5.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.38|0.61|0.2805
71140862|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|3.1||||0.0602|TWO_SIDED|95.0|0.95|10.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||10.11|0.95|0.0602
71140863|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|1.41||||0.5087|TWO_SIDED|95.0|0.51|3.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.88|0.51|0.5087
71140864|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|2.26||||0.1224|TWO_SIDED|95.0|0.8|6.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.38|0.80|0.1224
71140865|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|1.85||||0.228|TWO_SIDED|95.0|0.68|5.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.02|0.68|0.2280
71140866|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|2.07||||0.1835|TWO_SIDED|95.0|0.71|6.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.02|0.71|0.1835
70948882|NCT01080300|141399076|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|7.5||||0.0609|TWO_SIDED|95.0|-0.3|15.2|||two-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|Week 12||15.2|-0.3|0.0609
71140867|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|5.85||||0.0107|TWO_SIDED|95.0|1.51|22.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||22.69|1.51|0.0107
70866595|NCT00569270|141219557|SUPERIORITY_OR_OTHER|||||||0.067||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Peak IC of tiotropium minus placebo.29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.067
71140868|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|2.94||||0.0576|TWO_SIDED|95.0|0.97|8.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.96|0.97|0.0576
71140869|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|9.68||||0.0047|TWO_SIDED|95.0|2.0|46.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||46.77|2.00|0.0047
71140870|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|2.89||||0.0569|TWO_SIDED|95.0|0.97|8.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.64|0.97|0.0569
70866596|NCT00569270|141219558|SUPERIORITY_OR_OTHER|||||||0.615||95.0||||A priori threshold for statistical significance: p\<0.05|Regression, Logistic|||Mean difference of Peak FRC/TLC of tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.615
70866597|NCT00569270|141219559|SUPERIORITY_OR_OTHER|||||||0.325||95.0||||Statistical significance was p\<0.05|Mixed Models Analysis|||29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.325
70866598|NCT00569270|141219560|SUPERIORITY_OR_OTHER|||||||0.345||95.0|||||Mixed Models Analysis|||29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.345
71140871|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|2.35||||0.1078|TWO_SIDED|95.0|0.83|6.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.68|0.83|0.1078
71140872|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0772|TWO_SIDED|95.0|0.9|7.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.47|0.90|0.0772
71140873|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|2.36||||0.1311|TWO_SIDED|95.0|0.77|7.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.22|0.77|0.1311
71140874|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|5.64||||0.01255|TWO_SIDED|95.0|1.45|21.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||21.96|1.45|0.01255
71140875|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|4.97||||0.0128|TWO_SIDED|95.0|1.41|17.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||17.54|1.41|0.0128
71140876|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|6.32||||0.0079|TWO_SIDED|95.0|1.62|24.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||24.63|1.62|0.0079
71140877|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0572|TWO_SIDED|95.0|0.97|8.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.67|0.97|0.0572
71140878|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|3.33||||0.0284|TWO_SIDED|95.0|1.14|9.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||9.79|1.14|0.0284
70866599|NCT00569270|141219561|SUPERIORITY_OR_OTHER|||||||0.068||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Trough FRC(L) in tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.068
70866600|NCT00569270|141219562|SUPERIORITY_OR_OTHER|||||||0.589||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of trough FVC in tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.589
71140879|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|2.58||||0.0705|TWO_SIDED|95.0|0.92|7.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.22|0.92|0.0705
71140880|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|4.81||||0.0136|TWO_SIDED|95.0|1.38|16.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||16.77|1.38|0.0136
71140881|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|9.96||||0.0043|TWO_SIDED|95.0|2.06|48.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||48.29|2.06|0.0043
71140882|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|2.66||||0.076|TWO_SIDED|95.0|0.9|7.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.83|0.90|0.0760
71140883|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|5.75||||0.0059|TWO_SIDED|95.0|1.65|20.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||20.00|1.65|0.0059
71140884|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|4.22||||0.0143|TWO_SIDED|95.0|1.33|13.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||13.35|1.33|0.0143
70948883|NCT01080300|141399076|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|7.3||||0.072|TWO_SIDED|95.0|-0.7|15.3|||two-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|Week 24||15.3|-0.7|0.0720
70948884|NCT01080300|141399077|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|3.8||||0.1825|TWO_SIDED|95.0|-1.8|9.4|||two-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|Week 12||9.4|-1.8|0.1825
70948885|NCT01080300|141399077|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|4.4||||0.1662|TWO_SIDED|95.0|-1.8|10.7|||two-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|Week 24||10.7|-1.8|0.1662
70948886|NCT01080300|141399078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.36|STANDARD_ERROR_OF_MEAN|0.196|<|0.0001|TWO_SIDED|95.0|-1.75|-0.97||The P value (versus placebo) for the pairwise test of difference of the LS mean change from Baseline between the G-ER 1800-mg and placebo-treatment groups was based on the F test of type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 4: LOCF daily sleep interference rating.||-0.97|-1.75|<0.0001
70948887|NCT01080300|141399078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.92|STANDARD_ERROR_OF_MEAN|0.226|<|0.0001|TWO_SIDED|95.0|-1.36|-0.47||The P value (versus placebo) for the pairwise test of difference of the LS mean change from Baseline between the G-ER 1800-mg and placebo-treatment groups was based on the F test of type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 12: LOCF daily sleep interference rating.||-0.47|-1.36|<0.0001
70948888|NCT01080300|141399078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.95|STANDARD_ERROR_OF_MEAN|0.237|<|0.0001|TWO_SIDED|95.0|-1.42|-0.49||The P value (versus placebo) for the pairwise test of difference of the LS mean change from Baseline between the G-ER 1800-mg and placebo-treatment groups was based on the F test of type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 24: LOCF daily sleep interference rating.||-0.49|-1.42|<0.0001
70948889|NCT01080300|141399079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.62|STANDARD_ERROR_OF_MEAN|0.537|<|0.0001|TWO_SIDED|95.0|-3.67|-1.56||The P value (versus placebo) for the pairwise test of difference of the LS mean change from Baseline between the G-ER 1800-mg and placebo-treatment groups was based on the F test of type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 4: LOCF daily insomnia severity index (ISI) rating.||-1.56|-3.67|<0.0001
70948890|NCT01080300|141399079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.85|STANDARD_ERROR_OF_MEAN|0.543||0.0007|TWO_SIDED|95.0|-2.92|-0.78||The P value (versus placebo) for the pairwise test of difference of the LS mean change from Baseline between the G-ER 1800-mg and placebo-treatment groups was based on the F test of type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 12: LOCF daily insomnia severity index (ISI) rating.||-0.78|-2.92|0.0007
70948891|NCT01080300|141399079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.76|STANDARD_ERROR_OF_MEAN|0.548||0.0014|TWO_SIDED|95.0|-2.84|-0.69|||ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 24: LOCF daily insomnia severity index (ISI) rating.||-0.69|-2.84|0.0014
70948892|NCT01080300|141399080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.084||0.0137|TWO_SIDED|95.0|-0.37|-0.04||The p-value (vs. Placebo) for the test of difference of the LS mean change from baseline between Gabapentin ER 1800mg and placebo group is based on the F-test of Type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||MENQOL score at Week 4||-0.04|-0.37|0.0137
70948893|NCT01080300|141399080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.084||0.0872|TWO_SIDED|95.0|-0.31|0.02||The p-value (vs. Placebo) for the test of difference of the LS mean change from baseline between Gabapentin ER 1800mg and placebo group is based on the F-test of Type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||MENQOL score at Week 12||0.02|-0.31|0.0872
70948894|NCT01080300|141399080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.091||0.5607|TWO_SIDED|95.0|-0.23|0.13||The p-value (vs. Placebo) for the test of difference of the LS mean change from baseline between Gabapentin ER 1800mg and placebo group is based on the F-test of Type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||MENQOL score at Week 24||0.13|-0.23|0.5607
70948895|NCT01575873|141399111|NON_INFERIORITY|Non-inferiority was shown if the lower bound of the two-sided 95% CI for the difference between the least-squares means (denosumab minus risedronate) was higher than the prespecified non-inferiority margin of -1.1 percentage points for the glucocorticoid-initiating subpopulation.|LS Mean Difference|2.9|||<|0.001|TWO_SIDED|95.0|2.0|3.9||One-sided p-value based on the prespecified noninferiority margin for lumbar spine of -1.1%.|ANCOVA||Least Squares (LS) Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within the glucocorticoid-continuing and glucocorticoid-initiating subpopulations. A fixed-sequence testing procedure was used to control the experiment-wise type 1 error rate at a two-sided 5% significance level within each subpopulation.~The glucocorticoid-initiating subpopulation was analyzed using an ANCOVA model adjusting for treatment, baseline BMD, sex, machine type, and baseline BMD-by-machine type interaction."||3.9|2.0|< 0.001
70948896|NCT01575873|141399111|NON_INFERIORITY|Non-inferiority was shown if the lower bound of the two-sided 95% CI for the difference between the least-squares means (denosumab minus risedronate) was higher than the prespecified non-inferiority margin of -0.7 percentage points for the glucocorticoid-continuing subpopulation.|LS Mean Difference|2.2|||<|0.001|TWO_SIDED|95.0|1.4|3.0||One-sided p-value based on the prespecified noninferiority margins for lumbar spine of -0.7%.|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-continuing subpopulation was analyzed using an ANCOVA model adjusted for treatment, baseline BMD, sex, machine type, baseline BMD-by-machine type interaction, and duration of prior glucocorticoid use (\< 12 months vs ≥ 12 months)."||3.0|1.4|< 0.001
70948897|NCT01575873|141399112|SUPERIORITY||LS Mean Difference|2.9|||<|0.001|TWO_SIDED|95.0|2.0|3.9||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-initiating subpopulation was analyzed using an ANCOVA model adjusting for treatment, baseline BMD value, sex, machine type, and baseline BMD value-by-machine type interaction."||3.9|2.0|< 0.001
70948898|NCT01575873|141399112|SUPERIORITY||LS Mean Difference|2.2|||<|0.001|TWO_SIDED|95.0|1.4|3.0||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-continuing subpopulation was analyzed using an ANCOVA model adjusted for treatment, baseline BMD, sex, machine type, baseline BMD-by-machine type interaction, and duration of prior glucocorticoid use (\< 12 months vs ≥ 12 months)."||3.0|1.4|< 0.001
70948899|NCT01575873|141399113|SUPERIORITY||LS Mean Difference|1.5|||<|0.001|TWO_SIDED|95.0|0.8|2.1||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-initiating subpopulation was analyzed using an ANCOVA model adjusting for treatment, baseline BMD value, sex, machine type, and baseline BMD value-by-machine type interaction."||2.1|0.8|< 0.001
70948900|NCT01575873|141399113|SUPERIORITY||LS Mean Difference|1.5|||<|0.001|TWO_SIDED|95.0|1.0|2.1||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-continuing subpopulation was analyzed using an ANCOVA model adjusted for treatment, baseline BMD, sex, machine type, baseline BMD-by-machine type interaction, and duration of prior glucocorticoid use (\< 12 months vs ≥ 12 months)."||2.1|1.0|< 0.001
70948901|NCT01575873|141399114|SUPERIORITY||LS Mean Difference|4.5|||<|0.001|TWO_SIDED|95.0|3.2|5.8||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-initiating subpopulation was analyzed using an ANCOVA model adjusting for treatment, baseline BMD value, sex, machine type, and baseline BMD value-by-machine type interaction."||5.8|3.2|< 0.001
70948902|NCT01575873|141399114|SUPERIORITY||LS Mean Difference|3.2|||<|0.001|TWO_SIDED|95.0|2.0|4.3||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-continuing subpopulation was analyzed using an ANCOVA model adjusted for treatment, baseline BMD, sex, machine type, baseline BMD-by-machine type interaction, and duration of prior glucocorticoid use (\< 12 months vs ≥ 12 months)."||4.3|2.0|< 0.001
71140885|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|1.82||||0.2779|TWO_SIDED|95.0|0.62|5.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.35|0.62|0.2779
71140886|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|1.18||||0.7559|TWO_SIDED|95.0|0.41|3.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.41|0.41|0.7559
71140887|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|1.07||||0.905|TWO_SIDED|95.0|0.35|3.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.23|0.35|0.9050
71140888|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|2.05||||0.2163|TWO_SIDED|95.0|0.66|6.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.38|0.66|0.2163
70866601|NCT00569270|141219563|SUPERIORITY_OR_OTHER|||||||0.922||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Trough IC of tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.922
70866602|NCT00569270|141219564|SUPERIORITY_OR_OTHER|||||||-0.02||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Trough FRC/TLC of tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||-0.02
71140889|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|2.24||||0.1713|TWO_SIDED|95.0|0.7|7.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.14|0.70|0.1713
71140890|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|1.63||||0.3981|TWO_SIDED|95.0|0.52|5.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.09|0.52|0.3981
71140891|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9692|TWO_SIDED|95.0|0.35|2.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||2.96|0.35|0.9692
71140892|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|1.77||||0.2978|TWO_SIDED|95.0|0.6|5.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.22|0.60|0.2978
71140893|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8525|TWO_SIDED|95.0|0.38|3.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.18|0.38|0.8525
71140894|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|0.67||||0.5028|TWO_SIDED|95.0|0.21|2.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.13|0.21|0.5028
71140895|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|1.53||||0.4594|TWO_SIDED|95.0|0.5|4.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.73|0.50|0.4594
71140896|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|2.56||||0.1124|TWO_SIDED|95.0|0.8|8.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||8.17|0.80|0.1124
70866603|NCT00569270|141219565|SUPERIORITY_OR_OTHER|||||||-0.13||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Trough TLC (L) of tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||-0.13
71140897|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|1.75||||0.3415|TWO_SIDED|95.0|0.55|5.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.58|0.55|0.3415
71140898|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|1.65||||0.3635|TWO_SIDED|95.0|0.56|4.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.83|0.56|0.3635
71140899|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|0.73||||0.5716|TWO_SIDED|95.0|0.24|2.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.20|0.24|0.5716
71140900|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|0.69||||0.5028|TWO_SIDED|95.0|0.23|2.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.05|0.23|0.5028
71140901|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|0.6||||0.3982|TWO_SIDED|95.0|0.18|1.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.98|0.18|0.3982
70948903|NCT01575873|141399115|SUPERIORITY||LS Mean Difference|3.1|||<|0.001|TWO_SIDED|95.0|2.2|3.9||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-initiating subpopulation was analyzed using an ANCOVA model adjusting for treatment, baseline BMD value, sex, machine type, and baseline BMD value-by-machine type interaction."||3.9|2.2|< 0.001
70866604|NCT00569270|141219566|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Change in IC before and after dynamic hyperinflation. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.0001
70866605|NCT00569270|141219567|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Total lung capacity was similar in all groups and was not significant|Mixed Models Analysis|||29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||>0.05
70866606|NCT00569270|141219568|SUPERIORITY_OR_OTHER|||||||0.36||95.0||||A priori threshold for statistical significance: p= 0.05|Spearman rho|Spearman rho = -0.26||Correlation between improved lung function after tiotropium and extent of lung CT scored emphysema with respect to ratio functional residual capacity divided by total lung capacity. Specifically, correlation of tiotropium induced bronchodilation and extent of lung ct scored emphysema||||0.36
70948904|NCT01575873|141399115|SUPERIORITY||LS Mean Difference|2.5|||<|0.001|TWO_SIDED|95.0|1.7|3.2||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-continuing subpopulation was analyzed using an ANCOVA model adjusted for treatment, baseline BMD, sex, machine type, baseline BMD-by-machine type interaction, and duration of prior glucocorticoid use (\< 12 months vs ≥ 12 months)."||3.2|1.7|< 0.001
70948905|NCT00762476|141399120|SUPERIORITY_OR_OTHER||||||>|0.5|TWO_SIDED|95.0|||||Poisson regression|||||||>0.5000
70948906|NCT00762476|141399121|SUPERIORITY_OR_OTHER||||||>|0.5|TWO_SIDED|95.0|||||Poisson regression|||||||>0.5000
71140902|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|0.93||||0.93|TWO_SIDED|95.0|0.3|2.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.87|0.30|0.93
70948907|NCT00762476|141399122|SUPERIORITY_OR_OTHER|||||||0.3451|TWO_SIDED|95.0|||||Poisson regression|||||||0.3451
70948908|NCT00965497|141399131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|95.0||||0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||There were 13 people that completed so there truly was no power to detect true differences; therefore only trends can be discussed.||||0.01
70948909|NCT01827046|141399151|SUPERIORITY||Risk Difference (RD)|2.0||||0.73|TWO_SIDED|95.0|-6.8|10.7|||Chi-squared|||||10.7|-6.8|0.73
70866607|NCT03407625|141219602|SUPERIORITY||Risk Ratio (RR)|1.0||||0.86|TWO_SIDED|95.0|0.95|1.05|||log binomial regression||||We used generalized estimating equations for the log binomial regression with cluster entered as a random effect.|1.05|0.95|0.86
70948910|NCT01827046|141399151|SUPERIORITY||Risk Difference (RD)|4.0||||0.33|TWO_SIDED|95.0|-4.0|12.0|||Multivariate logit model|||Adjusted for age, GCS, stability ICH volume, stability IVH volume, ICH deep location||12|-4|0.33
70948911|NCT01827046|141399152|SUPERIORITY||Risk Difference (RD)|0.03||||0.55|TWO_SIDED|95.0|-0.06|0.11|||Chi-squared|||||0.11|-0.06|0.55
70948912|NCT01827046|141399152|SUPERIORITY||Risk Difference (RD)|1.26||||0.27|TWO_SIDED|95.0|0.82|1.97|||Multivariate logit model|Adjusted for age, GCS, stability ICH volume, stability IVH volume and ICH deep location||||1.97|0.82|0.27
70948913|NCT01827046|141399153|SUPERIORITY|||||||0.08|TWO_SIDED|95.0|||||Log Rank|||||||0.08
71140903|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|2.12||||0.2364|TWO_SIDED|95.0|0.61|7.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||7.32|0.61|0.2364
71140904|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|1.25||||0.7095|TWO_SIDED|95.0|0.39|4.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||4.04|0.39|0.7095
71140905|NCT03192176|141778529|SUPERIORITY||Odds Ratio (OR)|0.75||||0.6011|TWO_SIDED|95.0|0.26|2.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.20|0.26|0.6011
71140906|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|6.78||||0.0181|TWO_SIDED|95.0|1.39|33.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||33.10|1.39|0.0181
71140907|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|9.97||||0.0039|TWO_SIDED|95.0|2.1|47.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||47.48|2.10|0.0039
71140908|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|21.2||||0.0001|TWO_SIDED|95.0|4.51|99.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||99.65|4.51|0.0001
71140909|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|23.97|||<|0.0001|TWO_SIDED|95.0|5.09|112.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||112.9|5.09|<0.0001
71140910|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|3.17||||0.1766|TWO_SIDED|95.0|0.59|16.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.87|0.59|0.1766
70866608|NCT04154930|141219626|SUPERIORITY||Treatment difference|69.7|||<|0.001|TWO_SIDED|95.0|52.54|86.89|||Cochran-Mantel-Haenszel|||||86.89|52.54|<0.001
70866609|NCT04154930|141219627|SUPERIORITY||Treatment difference|72.5|||<|0.001|TWO_SIDED|95.0|60.67|84.28|||Cochran-Mantel-Haenszel|||Responder Rate Based on the Blinded Evaluator's live assessment of the GIHS at 6 Months After Baseline||84.28|60.67|<0.001
71140911|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|7.68||||0.0116|TWO_SIDED|95.0|1.58|37.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||37.43|1.58|0.0116
71140912|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|12.74||||0.0013|TWO_SIDED|95.0|2.71|59.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||59.81|2.71|0.0013
71140913|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|2.82||||0.0359|TWO_SIDED|95.0|1.07|7.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.43|1.07|0.0359
71140914|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|5.8||||0.0004|TWO_SIDED|95.0|2.2|15.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||15.33|2.20|0.0004
71140915|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|7.13|||<|0.0001|TWO_SIDED|95.0|2.68|18.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||18.98|2.68|<0.0001
71140916|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|6.84||||0.0001|TWO_SIDED|95.0|2.53|18.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||18.46|2.53|0.0001
71140917|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|2.04||||0.154|TWO_SIDED|95.0|0.76|5.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.47|0.76|0.1540
71140918|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|3.84||||0.0065|TWO_SIDED|95.0|1.46|10.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.12|1.46|0.0065
71140919|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|3.9||||0.0052|TWO_SIDED|95.0|1.5|10.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.14|1.50|0.0052
70866610|NCT04154930|141219627|SUPERIORITY||Treatment difference|66.4|||<|0.001|TWO_SIDED|95.0|54.97|77.92|||Cochran-Mantel-Haenszel|||Responder Rate Based on the Blinded Evaluator's live assessment of the GIHS at 9 Months After Baseline||77.92|54.97|<0.001
70866611|NCT04154930|141219627|SUPERIORITY||Treatment difference|52.4|||<|0.001|TWO_SIDED|95.0|40.57|64.26|||Cochran-Mantel-Haenszel|||Responder Rate Based on the Blinded Evaluator's live assessment of the GIHS at 12 Months After Baseline||64.26|40.57|<0.001
70866612|NCT00347360|141219633|SUPERIORITY_OR_OTHER||||||>|0.1||95.0|||||Hung AVE test, see comments|Hung AVE Test Statistic: -0.41499. Tests an average of the minimum gains (in response) for the 9 combination cells over corresponding monotherapies.||This is an omnibus test to investigate the existence of at least one combination dose that outperforms its components.||||>0.1
70948914|NCT01827046|141399153|SUPERIORITY||Cox Proportional Hazard|0.67||||0.037|TWO_SIDED|95.0|0.45|0.98|||Adjusted Cox proportional Hazard|Adjusted for age, GCS, Stability ICH volume, Stability IVH volume, ICH deep location, diabetes, cardiovascular disease and race.||||0.98|0.45|0.037
71140920|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|3.68||||0.0064|TWO_SIDED|95.0|1.44|9.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.39|1.44|0.0064
71140921|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|5.86||||0.0003|TWO_SIDED|95.0|2.26|15.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||15.21|2.26|0.0003
71140922|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|6.42||||0.0001|TWO_SIDED|95.0|2.47|16.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||16.69|2.47|0.0001
71140923|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|8.21|||<|0.0001|TWO_SIDED|95.0|3.01|22.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||22.42|3.01|<0.0001
71140924|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|3.12||||0.0171|TWO_SIDED|95.0|1.22|7.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.97|1.22|0.0171
71140925|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|4.38||||0.002|TWO_SIDED|95.0|1.71|11.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||11.18|1.71|0.0020
71140926|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|3.97||||0.0034|TWO_SIDED|95.0|1.58|9.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.99|1.58|0.0034
71140927|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|2.63||||0.0399|TWO_SIDED|95.0|1.05|6.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.59|1.05|0.0399
71140928|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|5.76||||0.0003|TWO_SIDED|95.0|2.23|14.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||14.84|2.23|0.0003
71140929|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|4.05||||0.0031|TWO_SIDED|95.0|1.6|10.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.23|1.60|0.0031
71140930|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|9.82|||<|0.0001|TWO_SIDED|95.0|3.41|28.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||28.28|3.41|<0.0001
70866613|NCT00347360|141219634|SUPERIORITY_OR_OTHER||||||>|0.1||95.0|||||Hung AVE test, see comments|Hung AVE Test Statistic: -0.00485. Tests an average of the minimum gains (in response) for the 9 combination cells over corresponding monotherapies.||This is an omnibus test to investigate the existence of at least one combination dose that outperforms its components.||||>0.1
70866614|NCT00806351|141219671|SUPERIORITY_OR_OTHER||Risk Difference|-27.3|||||TWO_SIDED|95.0|-80.9|40.3||||||The 95 percent confidence interval (95% CI) was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||40.3|-80.9|
70948915|NCT01827046|141399154|SUPERIORITY||Odds Ratio (OR)|0.7|||<|0.001|TWO_SIDED|95.0|0.62|0.8|||Logit model|||||0.80|0.62|<0.001
70948916|NCT01827046|141399154|SUPERIORITY||Odds Ratio (OR)|0.68|||<|0.001|TWO_SIDED|95.0|0.59|0.78|||Multivariate logit model|Adjusted for age, GCS, stability IVH volume, and ICH deep location||||0.78|0.59|<0.001
70948917|NCT01827046|141399155|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
71140931|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|3.96||||0.0036|TWO_SIDED|95.0|1.57|10.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.01|1.57|0.0036
71140932|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|4.79||||0.0009|TWO_SIDED|95.0|1.89|12.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||12.11|1.89|0.0009
71140933|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|3.33||||0.0091|TWO_SIDED|95.0|1.35|8.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.21|1.35|0.0091
71140934|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|1.78||||0.2043|TWO_SIDED|95.0|0.73|4.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.34|0.73|0.2043
71140935|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|4.7||||0.0012|TWO_SIDED|95.0|1.84|12.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||12.01|1.84|0.0012
71140936|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|3.77||||0.0058|TWO_SIDED|95.0|1.47|9.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||9.70|1.47|0.0058
71140937|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|8.07||||0.0002|TWO_SIDED|95.0|2.73|23.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||23.83|2.73|0.0002
71140938|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|2.88||||0.0221|TWO_SIDED|95.0|1.16|7.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.12|1.16|0.0221
71140939|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0034|TWO_SIDED|95.0|1.58|10.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||10.13|1.58|0.0034
71140940|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|3.22||||0.0123|TWO_SIDED|95.0|1.29|8.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.04|1.29|0.0123
71140941|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|1.56||||0.3291|TWO_SIDED|95.0|0.64|3.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.78|0.64|0.3291
71140942|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|3.27||||0.0118|TWO_SIDED|95.0|1.3|8.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||8.21|1.30|0.0118
71140943|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|3.93||||0.0058|TWO_SIDED|95.0|1.49|10.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||10.40|1.49|0.0058
71140944|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|5.98||||0.0012|TWO_SIDED|95.0|2.03|17.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||17.65|2.03|0.0012
71140945|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|2.13||||0.1043|TWO_SIDED|95.0|0.85|5.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.32|0.85|0.1043
71140946|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|5.01||||0.0015|TWO_SIDED|95.0|1.85|13.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||13.54|1.85|0.0015
70948918|NCT01827046|141399156|SUPERIORITY||Risk Difference (RD)|0.04||||0.34|TWO_SIDED|95.0|-0.04|0.11|||Chi-squared|||||0.11|-0.04|0.34
70948919|NCT01827046|141399157|SUPERIORITY||Risk Difference (RD)|-0.01||||0.76|TWO_SIDED|95.0|-0.1|0.07|||Chi-squared|||||0.07|-0.10|0.76
71140947|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0658|TWO_SIDED|95.0|0.95|5.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.73|0.95|0.0658
70948920|NCT01827046|141399157|SUPERIORITY||Odds Ratio (OR)|1.25||||0.31|TWO_SIDED|95.0|0.81|1.94|||Multivariate logit model|Adjusted for age, GCS, Stability ICH volume, Stability IVH volume, ICH deep location||||1.94|0.81|0.31
70948921|NCT01827046|141399158|SUPERIORITY||Risk Difference (RD)|0.01||||0.79|TWO_SIDED|95.0|-0.07|0.09|||Chi-squared|||||0.09|-0.07|0.79
70866615|NCT00806351|141219672|SUPERIORITY_OR_OTHER||Risk Difference|-27.3|||||TWO_SIDED|95.0|-80.9|40.3||||||The 95% CI was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||40.3|-80.9|
70948922|NCT01827046|141399158|SUPERIORITY||Odds Ratio (OR)|1.24||||0.35|TWO_SIDED|95.0|0.79|1.97|||Multivariate logit model|Adjusted for age, GCS, Stability ICH volume, Stability IVH volume, ICH deep location||||1.97|0.79|0.35
70948923|NCT01827046|141399159|SUPERIORITY|||||||0.46|||||||Median test|||||||0.46
70948924|NCT01827046|141399160|SUPERIORITY|||||||0.75|||||||Median test|||||||0.75
70948925|NCT01827046|141399161|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||0.66
70948926|NCT01827046|141399162|SUPERIORITY|||||||0.87|||||||Chi-squared|||||||0.87
70948927|NCT01827046|141399163|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||0.02
70948928|NCT01827046|141399164|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
70948929|NCT01827046|141399165|SUPERIORITY|||||||0.32|||||||Chi-squared|||||||0.32
70948930|NCT01827046|141399166|SUPERIORITY|||||||0.16|||||||Chi-squared|||||||0.16
70948931|NCT01827046|141399167|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
70948932|NCT02296892|141399205|SUPERIORITY||Difference in Rates|0.7588|||<|0.0001|TWO_SIDED|95.0|0.6903|0.8274|||Cochran-Mantel-Haenszel|||||0.8274|0.6903|<0.0001
70948933|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|2.39|||||TWO_SIDED|95.0|1.39|4.1|||ANOVA|||Day 1, Men A, Pairwise comparison of geometric mean titer||4.1|1.39|
70948934|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|0.71|||||TWO_SIDED|95.0|0.42|1.2|||ANOVA|||Day 1, Men A, Pairwise comparison of geometric mean titer||1.2|0.42|
70948935|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|1.68|||||TWO_SIDED|95.0|0.98|2.9|||ANOVA|||Day 1, Men A, Pairwise comparison of geometric mean titer||2.9|0.98|
70948936|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|1.31|||||TWO_SIDED|95.0|0.59|2.91|||ANOVA|||Day 8, Men A, Pairwise comparison of geometric mean titer||2.91|0.59|
70948937|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|24.0|||||TWO_SIDED|95.0|11.0|52.0|||ANOVA|||Day 8, Men A, Pairwise comparison of geometric mean titer||52|11|
70948938|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|31.0|||||TWO_SIDED|95.0|14.0|69.0|||ANOVA|||Day 8, Men A, Pairwise comparison of geometric mean titer||69|14|
70948939|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|1.3|||||TWO_SIDED|95.0|0.7|2.42|||ANOVA|||Day 29, Men A, Pairwise comparison of geometric mean titer||2.42|0.7|
70948940|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|5.56|||||TWO_SIDED|95.0|3.01|10.0|||ANOVA|||Day 29, Men A, Pairwise comparison of geometric mean titer||10|3.01|
70948941|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|7.22|||||TWO_SIDED|95.0|3.86|13.0|||ANOVA|||Day 29, Men A, Pairwise comparison of geometric mean titer||13|3.86|
70948942|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|2.64|||||TWO_SIDED|95.0|1.4|4.99|||ANOVA|||Day 1, Men C, Pairwise comparison of geometric mean titer||4.99|1.4|
70948943|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|1.05|||||TWO_SIDED|95.0|0.56|1.97|||ANOVA|||Day 1, Men C, Pairwise comparison of geometric mean titer||1.97|0.56|
70948944|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|2.78|||||TWO_SIDED|95.0|1.47|5.27|||ANOVA|||Day 1, Men C, Pairwise comparison of geometric mean titer||5.27|1.47|
70948945|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|0.52|||||TWO_SIDED|95.0|0.23|1.13|||ANOVA|||Day 8, Men C, Pairwise comparison of geometric mean titer||1.13|0.23|
70948946|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|45.0|||||TWO_SIDED|95.0|21.0|97.0|||ANOVA|||Day 8, Men C, Pairwise comparison of geometric mean titer||97|21|
70948947|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|23.0|||||TWO_SIDED|95.0|10.0|51.0|||ANOVA|||Day 8, Men C, Pairwise comparison of geometric mean titer||51|10|
70948948|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|0.4|||||TWO_SIDED|95.0|0.2|0.82|||ANOVA|||Day 29, Men C, Pairwise comparison of geometric mean titer||0.82|0.2|
70948949|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|24.0|||||TWO_SIDED|95.0|12.0|48.0|||ANOVA|||Day 29, Men C, Pairwise comparison of geometric mean titer||48|12|
70948950|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|9.61|||||TWO_SIDED|95.0|4.69|20.0|||ANOVA|||Day 29, Men C, Pairwise comparison of geometric mean titer||20|4.69|
70948951|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|1.11|||||TWO_SIDED|95.0|0.55|2.21|||ANOVA|||Day 1, Men W-135, Pairwise comparison of geometric mean titer||2.21|0.55|
70948952|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|2.51|||||TWO_SIDED|95.0|1.27|4.96|||ANOVA|||Day 1, Men W-135, Pairwise comparison of geometric mean titer||4.96|1.27|
70948953|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|2.77|||||TWO_SIDED|95.0|1.38|5.57|||ANOVA|||Day 1, Men W-135, Pairwise comparison of geometric mean titer||5.57|1.38|
70948954|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|0.54|||||TWO_SIDED|95.0|0.28|1.04|||ANOVA|||Day 8, Men W-135, Pairwise comparison of geometric mean titer||1.04|0.28|
70948955|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|50.0|||||TWO_SIDED|95.0|26.0|94.0|||ANOVA|||Day 8, Men W-135, Pairwise comparison of geometric mean titer||94|26|
70948956|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|27.0|||||TWO_SIDED|95.0|14.0|52.0|||ANOVA|||Day 8, Men W-135, Pairwise comparison of geometric mean titer||52|14|
70948957|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|0.6|||||TWO_SIDED|95.0|0.34|1.04|||ANOVA|||Day 29, Men W-135, Pairwise comparison of geometric mean titer||1.04|0.34|
70948958|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|35.0|||||TWO_SIDED|95.0|20.0|60.0|||ANOVA|||Day 29, Men W-135, Pairwise comparison of geometric mean titer||60|20|
70948959|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|21.0|||||TWO_SIDED|95.0|12.0|36.0|||ANOVA|||Day 29, Men W-135, Pairwise comparison of geometric mean titer||36|12|
70948960|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|0.9|||||TWO_SIDED|95.0|0.48|1.69|||ANOVA|||Day 1, Men Y, Pairwise comparison of geometric mean titer||1.69|0.48|
70948961|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|3.61|||||TWO_SIDED|95.0|1.94|6.74||||||Day 1, Men Y, Pairwise comparison of geometric mean titer||6.74|1.94|
70948962|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|3.24|||||TWO_SIDED|95.0|1.71|6.13|||ANOVA|||Day 1, Men Y, Pairwise comparison of geometric mean titer||6.13|1.71|
70948963|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|0.33|||||TWO_SIDED|95.0|0.16|0.66|||ANOVA|||Day 8, Men Y, Pairwise comparison of geometric mean titer||0.66|0.16|
70948964|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|121.0|||||TWO_SIDED|95.0|61.0|241.0|||ANOVA|||Day 8, Men Y, Pairwise comparison of geometric mean titer||241|61|
70948965|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|40.0|||||TWO_SIDED|95.0|20.0|80.0|||ANOVA|||Day 8, Men Y, Pairwise comparison of geometric mean titer||80|20|
70948966|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|0.58|||||TWO_SIDED|95.0|0.32|1.05|||ANOVA|||Day 29, Men Y, Pairwise comparison of geometric mean titer||1.05|0.32|
70948967|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|33.0|||||TWO_SIDED|95.0|18.0|60.0|||ANOVA|||Day 29, Men Y, Pairwise comparison of geometric mean titer||60|18|
70948968|NCT01018732|141399214|SUPERIORITY_OR_OTHER||ratio of titer|19.0|||||TWO_SIDED|95.0|10.0|35.0|||ANOVA|||Day 29, Men Y, Pairwise comparison of geometric mean titer||35|10|
70948969|NCT02165826|141399324|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.017|TWO_SIDED|95.0|0.47|0.93||Study treatment, country and baseline forced expiratory volume in the first second (FEV1) as explanatory variables.|Regression, Logistic|||Analyses were performed using a hierarchical testing procedure.||0.93|0.47|0.017
70948970|NCT02165826|141399324|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.68|||||TWO_SIDED|95.0|0.51|0.92|||||Cox proportional hazards model with study treatment and country as class effects, and baseline FEV1 as a continuous variable.|Analyses were performed using a hierarchical testing procedure.||0.92|0.51|
70948971|NCT02165826|141399324|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.114|TWO_SIDED|95.0|0.55|1.07||Study treatment, country and baseline forced expiratory volume in the first second (FEV1) as explanatory variables.|Regression, Logistic|||Analyses were performed using a hierarchical testing procedure.||1.07|0.55|0.114
70948972|NCT02165826|141399324|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.77|||||TWO_SIDED|95.0|0.58|1.02|||||Cox proportional hazards model with study treatment and country as class effects, and baseline FEV1 as a continuous variable.|Analyses were performed using a hierarchical testing procedure.||1.02|0.58|
70948973|NCT02165826|141399325|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63||||0.001|TWO_SIDED|95.0|0.47|0.83||Study treatment, country and baseline forced expiratory volume in the first second (FEV1) as explanatory variables.|Regression, Logistic|||Analyses were performed using a hierarchical testing procedure.||0.83|0.47|0.001
70948974|NCT02165826|141399325|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.091|TWO_SIDED|95.0|0.59|1.04||Study treatment, country and baseline forced expiratory volume in the first second (FEV1) as explanatory variables.|Regression, Logistic|||Analyses were performed using a hierarchical testing procedure.||1.04|0.59|0.091
70948975|NCT01936467|141399350|OTHER||Sensitivity|93.7|||||TWO_SIDED|||||||||||||
70948976|NCT01936467|141399350|OTHER||Specificity|100.0|||||TWO_SIDED|||||||||||||
71140948|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|2.02||||0.1253|TWO_SIDED|95.0|0.82|4.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.98|0.82|0.1253
70948977|NCT01936467|141399351|OTHER||Sensitivity|88.6|||||TWO_SIDED|||||||||||||
70948978|NCT01936467|141399351|OTHER||Specificity|100.0|||||TWO_SIDED|||||||||||||
70948979|NCT01936467|141399352|OTHER|||||||0.47|||||||Chi-squared|||||||0.47
70948980|NCT01936467|141399353|SUPERIORITY_OR_OTHER|||||||0.71|||||||Chi-squared|||||||0.71
70948981|NCT01936467|141399354|SUPERIORITY_OR_OTHER|||||||0.15|||||||Chi-squared|||||||0.15
70948982|NCT01936467|141399355|SUPERIORITY_OR_OTHER|||||||0.46|||||||Chi-squared|||||||0.46
70948983|NCT04547023|141399361|OTHER||Mean Difference (Final Values)|18.7||||0.002|TWO_SIDED|95.0|7.2|30.1|||Fisher Exact|||||30.1|7.2|0.002
71140949|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|5.01||||0.0013|TWO_SIDED|95.0|1.88|13.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||13.34|1.88|0.0013
71140950|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|3.66||||0.0096|TWO_SIDED|95.0|1.37|9.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.75|1.37|0.0096
70948984|NCT00250432|141399389|NON_INFERIORITY_OR_EQUIVALENCE|Safety with caspofungin 150 mg daily will be non-inferior to that of caspofungin 70/50 mg. Non-inferiority was defined as upper limit of the 2-sided, 95% confidence interval for the difference (150-mg group - 70/50-mg group) must be less than 0.15 (15 percentage points).|Rate Difference|1.1|STANDARD_ERROR_OF_MEAN|5.6||||95.0|-4.1|6.8|||||The confidence interval computation was based on the method by Miettinen and Nurminen.|A significant drug-related adverse event was defined as either a drug-related serious adverse event or a drug-related adverse event leading to discontinuation of caspofungin therapy. Comparison between the 2 caspofungin groups was based on upper bound of the 95% confidence interval for the difference.||6.8|-4.1|
70948985|NCT00250432|141399390|SUPERIORITY_OR_OTHER||Rate Difference|6.3|STANDARD_ERROR_OF_MEAN|12.1||||95.0|-5.9|18.4|||||The 95% confidence interval on the difference will be based on the method of Miettinen and Nurminen.|There was no formal hypothesis testing for efficacy in this study. The main efficacy analysis was the number (percentage) of patients with a favorable overall response at the end of caspofungin study therapy, together with the within treatment 95% exact binomial confidence intervals, and the estimated treatment difference, and its 95% confidence interval.||18.4|-5.9|
70948986|NCT01011868|141399391|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|97.5|-0.78|-0.33||Hypotheses were tested at significance level of 0.025, which is half of overall alpha of 0.05, split equally between 2 treatment comparisons. This maintained the overall type-I (alpha) at 5%. There was no a priori assumption on testing order.|ANCOVA|ANCOVA that included treatment group and geographic region as fixed effects along with baseline HbA1c as covariate.|The primary analysis consisted of the pair-wise comparisons between each dose of empagliflozin versus placebo using the adjusted means from the model.|"The null and alternative hypotheses to be tested:~* H0,1: No difference in change from baseline to Week 18 in HbA1c between empagliflozin 10 mg and placebo~* H1,1: A difference in change from baseline to Week 18 in HbA1c between empagliflozin 10 mg and placebo"||-0.33|-0.78|<0.0001
70948987|NCT01011868|141399391|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|97.5|-0.93|-0.47||Hypotheses were tested at significance level of 0.025, which is half of overall alpha of 0.05, split equally between 2 treatment comparisons. This maintained the overall type-I (alpha) at 5%. There was no a priori assumption on testing order.|ANCOVA|ANCOVA that included treatment group and geographic region as fixed effects along with baseline HbA1c as covariate.|The primary analysis consisted of the pair-wise comparisons between each dose of empagliflozin versus placebo using the adjusted means from the model.|"The null and alternative hypotheses to be tested:~* H0,2: No difference in change from baseline to Week 18 in HbA1c between empagliflozin 25 mg and placebo~* H1,2: A difference in change from baseline to Week 18 in HbA1c between empagliflozin 25 mg and placebo"||-0.47|-0.93|<0.0001
70948988|NCT01011868|141399392|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.518|||<|0.0001|TWO_SIDED|95.0|3.262|9.334|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c.||Empagliflozin 10 mg vs Placebo at 18 weeks||9.334|3.262|<0.0001
70948989|NCT01011868|141399392|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.883|||<|0.0001|TWO_SIDED|95.0|2.859|8.338|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 18 weeks||8.338|2.859|<0.0001
70948990|NCT01011868|141399392|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.471|||<|0.0001|TWO_SIDED|95.0|2.077|5.802|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 10 mg vs Placebo at 54 weeks||5.802|2.077|<0.0001
70948991|NCT01011868|141399392|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.825|||<|0.0001|TWO_SIDED|95.0|2.268|6.451|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 54 weeks||6.451|2.268|<0.0001
70948992|NCT01011868|141399392|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.802||||0.0002|TWO_SIDED|95.0|1.639|4.789|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 10 mg vs Placebo at 78 weeks||4.789|1.639|0.0002
70948993|NCT01011868|141399392|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.527|||<|0.0001|TWO_SIDED|95.0|2.051|6.066|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 78 weeks||6.066|2.051|<0.0001
70948994|NCT01011868|141399393|SUPERIORITY_OR_OTHER||Adjusted mean difference|-28.4|STANDARD_ERROR_OF_MEAN|4.65|<|0.0001|TWO_SIDED|95.0|-37.54|-19.27|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 18 - Empagliflozin 10 mg vs Placebo||-19.27|-37.54|<0.0001
70866616|NCT00806351|141219673|SUPERIORITY_OR_OTHER||Risk Difference|-40.0|||||TWO_SIDED|95.0|-97.5|63.9||||||The 95% CI was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||63.9|-97.5|
70948995|NCT01011868|141399393|SUPERIORITY_OR_OTHER||Adjusted mean difference|-34.21|STANDARD_ERROR_OF_MEAN|4.81|<|0.0001|TWO_SIDED|95.0|-43.67|-24.76|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 18 - Empagliflozin 25 mg vs Placebo at 18 weeks||-24.76|-43.67|<0.0001
70866617|NCT00806351|141219674|SUPERIORITY_OR_OTHER||Risk Difference|-50.0|||||TWO_SIDED|95.0|-97.5|55.0||||||The 95% CI was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||55.0|-97.5|
70948996|NCT01011868|141399393|SUPERIORITY_OR_OTHER||Adjusted mean difference|-10.75|STANDARD_ERROR_OF_MEAN|5.02||0.0328|TWO_SIDED|95.0|-20.62|-0.89|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 54 - Empagliflozin 10 mg vs Placebo at 18 weeks||-0.89|-20.62|0.0328
70948997|NCT01011868|141399393|SUPERIORITY_OR_OTHER||Adjusted mean difference|-19.16|STANDARD_ERROR_OF_MEAN|5.16||0.0002|TWO_SIDED|95.0|-29.31|-9.01|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 54 - Empagliflozin 25 mg vs Placebo||-9.01|-29.31|0.0002
70948998|NCT01011868|141399393|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.03|STANDARD_ERROR_OF_MEAN|5.07||0.3216|TWO_SIDED|95.0|-15.01|4.94|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 78 - Empagliflozin 10 mg vs Placebo||4.94|-15.01|0.3216
70948999|NCT01011868|141399393|SUPERIORITY_OR_OTHER||Adjusted mean difference|-11.95|STANDARD_ERROR_OF_MEAN|5.23||0.0229|TWO_SIDED|95.0|-22.24|-1.67|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 78 - Empagliflozin 25 mg vs Placebo||-1.67|-22.24|0.0229
70949000|NCT01011868|141399394|SUPERIORITY_OR_OTHER||Adjusted mean difference|-25.12|STANDARD_ERROR_OF_MEAN|5.22|<|0.0001|TWO_SIDED|95.0|-35.38|-14.86|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 18 - Empagliflozin 10 mg vs Placebo||-14.86|-35.38|<0.0001
70949001|NCT01011868|141399394|SUPERIORITY_OR_OTHER||Adjusted mean difference|-31.01|||<|0.0001|TWO_SIDED|95.0|-41.62|-20.39|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 18 - Empagliflozin 25 mg vs Placebo||-20.39|-41.62|<0.0001
70949002|NCT01011868|141399394|SUPERIORITY_OR_OTHER||Adjusted mean difference|-10.2|STANDARD_ERROR_OF_MEAN|5.15|<|0.0484|TWO_SIDED|95.0|-20.33|-0.07|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 54 - Empagliflozin 10 mg vs Placebo||-0.07|-20.33|<0.0484
70949003|NCT01011868|141399394|SUPERIORITY_OR_OTHER||Adjusted mean difference|-19.42|STANDARD_ERROR_OF_MEAN|5.3||0.0003|TWO_SIDED|95.0|-29.84|-8.99|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 54 - Empagliflozin 25 mg vs Placebo||-8.99|-29.84|0.0003
70949004|NCT01011868|141399394|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.73|STANDARD_ERROR_OF_MEAN|5.07||0.3517||95.0|-14.71|5.25|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 78 - Empagliflozin 10 mg vs Placebo||5.25|-14.71|0.3517
70949005|NCT01011868|141399394|SUPERIORITY_OR_OTHER||Adjusted mean difference|-12.39|STANDARD_ERROR_OF_MEAN|5.23||0.0185|TWO_SIDED|95.0|-22.69|-2.1|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 78 - Empagliflozin 25 mg vs Placebo||-2.10|-22.69|0.0185
70949006|NCT01011868|141399395|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.58|STANDARD_ERROR_OF_MEAN|2.4||0.0213|TWO_SIDED|95.0|-10.32|-0.84|||Mixed Models Analysis||Week 54 model includes, baseline basal insulin, baseline HbA1c as linear covariate(s), geographical region, treatment, visit and visit by treatment interaction as fixed effects.|Empagliflozin versus Placebo 10 mg at 54 weeks||-0.84|-10.32|0.0213
71140951|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|6.06||||0.0012|TWO_SIDED|95.0|2.04|17.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||17.96|2.04|0.0012
70949007|NCT01011868|141399395|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.69|STANDARD_ERROR_OF_MEAN|2.49||0.0237|TWO_SIDED|95.0|-10.62|-0.77|||Mixed Models Analysis||Week 54 model includes, baseline basal insulin, baseline HbA1c as linear covariate(s), geographical region, treatment, visit and visit by treatment interaction as fixed effect(s).|Empagliflozin versus Placebo 25 mg at 54 weeks||-0.77|-10.62|0.0237
70949008|NCT01011868|141399395|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.66|STANDARD_ERROR_OF_MEAN|2.18||0.0024|TWO_SIDED|97.5|-11.56|-1.77||Hierarchical testing approach was applied to Empagliflozin 10 mg vs Placebo. If null hypothesis is rejected for the primary endpoint, at 0.025 (2-sided), testing of the key secondary endpoints continued in a hierarchical fashion for the same dose.|ANCOVA|Model for Week 78 includes baseline basal insulin, baseline HbA1c as linear covariate(s) and geographical region, treatment as fixed effect(s)||"Empagliflozin versus Placebo 10 mg at 78 weeks~H0,1a: No difference in change from baseline to Week 78 in basal insulin dose between Empagliflozin 10 mg and placebo H1,1a: A difference in change from baseline to Week 78 in basal insulin dose between Empagliflozin 10 mg and placebo"||-1.77|-11.56|0.0024
70949009|NCT01011868|141399395|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.92|STANDARD_ERROR_OF_MEAN|2.25||0.009|TWO_SIDED|97.5|-11.0|-0.85||Hierarchical testing approach was applied to Empagliflozin 25 mg vs Placebo. If null hypothesis is rejected for the primary endpoint, at 0.025 (2-sided), testing of the key secondary endpoints continued in a hierarchical fashion for the same dose.|ANCOVA|Model for Week 78 includes baseline basal insulin, baseline HbA1c as linear covariate(s) and geographical region, treatment as fixed effect(s)||"Empagliflozin versus Placebo 25 mg at 78 weeks~H0,1a: No difference in change from baseline to Week 78 in basal insulin dose between Empagliflozin 25 mg and placebo H1,1a: A difference in change from baseline to Week 78 in basal insulin dose between Empagliflozin 25 mg and placebo"||-0.85|-11.00|0.0090
71140952|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|2.75||||0.0344|TWO_SIDED|95.0|1.08|7.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.02|1.08|0.0344
71140953|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|4.07||||0.0045|TWO_SIDED|95.0|1.55|10.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||10.72|1.55|0.0045
71140954|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|2.24||||0.081|TWO_SIDED|95.0|0.91|5.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.55|0.91|0.0810
70949010|NCT01011868|141399396|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.04|STANDARD_ERROR_OF_MEAN|0.95||0.032|TWO_SIDED|95.0|-3.9|-0.18|||Mixed Models Analysis||Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 18 - Empagliflozin 10 mg vs Placebo||-0.18|-3.90|0.0320
71140955|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|2.29||||0.0761|TWO_SIDED|95.0|0.92|5.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.70|0.92|0.0761
71140956|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|3.66||||0.0078|TWO_SIDED|95.0|1.41|9.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||9.51|1.41|0.0078
71140957|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|2.99||||0.0253|TWO_SIDED|95.0|1.15|7.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.82|1.15|0.0253
71140958|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|6.23||||0.0017|TWO_SIDED|95.0|1.99|19.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||19.55|1.99|0.0017
71140959|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|1.55||||0.3512|TWO_SIDED|95.0|0.62|3.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.87|0.62|0.3512
71140960|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|2.77||||0.0352|TWO_SIDED|95.0|1.07|7.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.13|1.07|0.0352
71140961|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|2.36||||0.0704|TWO_SIDED|95.0|0.93|5.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.97|0.93|0.0704
71140962|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|1.94||||0.1651|TWO_SIDED|95.0|0.76|4.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.93|0.76|0.1651
71140963|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|2.21||||0.0964|TWO_SIDED|95.0|0.87|5.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.62|0.87|0.0964
71140964|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|3.12||||0.0276|TWO_SIDED|95.0|1.13|8.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.59|1.13|0.0276
71140965|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|4.99||||0.006|TWO_SIDED|95.0|1.58|15.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||15.70|1.58|0.0060
71140966|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|2.03||||0.1556|TWO_SIDED|95.0|0.76|5.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.39|0.76|0.1556
71140967|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|3.33||||0.0202|TWO_SIDED|95.0|1.21|9.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||9.18|1.21|0.0202
70949011|NCT01011868|141399396|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.99||0.3818|TWO_SIDED|95.0|-2.81|1.08|||Mixed Models Analysis||Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 18 - Empagliflozin 25 mg vs Placebo||1.08|-2.81|0.3818
70949012|NCT01011868|141399396|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.97|STANDARD_ERROR_OF_MEAN|0.47|<|0.0001|TWO_SIDED|95.0|-2.89|-1.05|||Mixed Models Analysis||Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 54 - Empagliflozin 10 mg vs Placebo||-1.05|-2.89|<0.0001
70949013|NCT01011868|141399396|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.17|STANDARD_ERROR_OF_MEAN|0.49|<|0.0001|TWO_SIDED|95.0|-3.13|-1.22|||Mixed Models Analysis||Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 54 - Empagliflozin 25 mg vs Placebo||-1.22|-3.13|<0.0001
70949014|NCT01011868|141399396|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.63|STANDARD_ERROR_OF_MEAN|1.1||0.0012|TWO_SIDED|95.0|-5.81|-1.45|||Mixed Models Analysis||Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 78 - Empagliflozin 10 mg vs Placebo||-1.45|-5.81|0.0012
70949015|NCT01011868|141399396|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.12|STANDARD_ERROR_OF_MEAN|1.15||0.0073|TWO_SIDED|95.0|-5.39|-0.85|||Mixed Models Analysis|Model includes, baseline weight, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects|Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 78 - Empagliflozin 25 mg vs Placebo||-0.85|-5.39|0.0073
70949016|NCT01011868|141399398|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.68|-0.26|||Mixed Models Analysis||Model includes baseline HbA1c as linear covariate(s), geographical region, treatment, visit and visit by treatment interaction as fixed effect(s).|Change from BL at week 54 - Empagliflozin 10 mg vs Placebo||-0.26|-0.68|<0.0001
70949017|NCT01011868|141399398|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.74|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.95|-0.52|||Mixed Models Analysis||Model includes baseline HbA1c as linear covariate(s), geographical region, treatment, visit and visit by treatment interaction as fixed effect(s).|Change from BL at week 54 - Empagliflozin 25 mg vs Placebo||-0.52|-0.95|<0.0001
70949018|NCT01011868|141399398|NON_INFERIORITY_OR_EQUIVALENCE|"For non-inferiority, a one-sided test at the significance level of 0.0125 was performed using a chosen margin of 0.3% difference between each dose of empagliflozin and placebo.~If the non-inferiority of empagliflozin to placebo with respect to change from baseline in HbA1c after 78 weeks of treatment could be concluded for a specific dose, subsequent testing of superiority was performed at the significance level of 0.025 for the relevant empagliflozin dose versus placebo comparison."|Adjusted mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.12||0.0001|TWO_SIDED|97.5|-0.73|-0.19||Hierarchical testing approach was applied to Empagliflozin 10 mg vs Placebo. If null hypothesis is rejected for the primary endpoint, at 0.025 (2-sided), testing of the key secondary endpoints continued in a hierarchical fashion for the same dose.|ANCOVA||Model includes baseline HbA1c as linear covariate(s), geographical region, treatment as fixed effect(s).|"Change from BL at week 78 - Empagliflozin 10 mg vs Placebo~H0,1b: The change from baseline to Week 78 in HbA1c between empagliflozin 10 mg and placebo ≥0.3% H1,1b: The change from baseline to Week 78 in HbA1c between empagliflozin 10 mg and placebo \<0.3%"||-0.19|-0.73|0.0001
70949019|NCT01011868|141399398|NON_INFERIORITY_OR_EQUIVALENCE|"For non-inferiority, a one-sided test at the significance level of 0.0125 was performed using a chosen margin of 0.3% difference between each dose of empagliflozin and placebo.~If the non-inferiority of empagliflozin to placebo with respect to change from baseline in HbA1c after 78 weeks of treatment could be concluded for a specific dose, subsequent testing of superiority was performed at the significance level of 0.025 for the relevant empagliflozin dose versus placebo comparison."|Adjusted mean difference|-0.62|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|97.5|-0.9|-0.34||Hierarchical testing approach was applied to Empagliflozin 25 mg vs Placebo. If null hypothesis is rejected for the primary endpoint, at 0.025 (2-sided), testing of the key secondary endpoints continued in a hierarchical fashion for the same dose.|ANCOVA||Model includes baseline HbA1c as linear covariate(s), geographical region, treatment as fixed effect(s).|"Change from BL at week 78 - Empagliflozin 25 mg vs Placebo~H0,1b: The change from baseline to Week 78 in HbA1c between empagliflozin 25 mg and placebo ≥0.3% H1,1b: The change from baseline to Week 78 in HbA1c between empagliflozin 25 mg and placebo \<0.3%"||-0.34|-0.90|<0.0001
70949020|NCT01011868|141399400|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.096||||0.0005|TWO_SIDED|95.0|1.846|9.088|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 10 mg vs Placebo at 18 weeks||9.088|1.846|0.0005
70949021|NCT01011868|141399400|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.636||||0.0002|TWO_SIDED|95.0|2.083|10.321|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 18 weeks||10.321|2.083|0.0002
70866618|NCT00806351|141219679|SUPERIORITY_OR_OTHER||Risk Difference|-36.4|||||TWO_SIDED|95.0|-90.6|31.9||||||The 95% CI was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||31.9|-90.6|
70949022|NCT01011868|141399400|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.1248|TWO_SIDED|95.0|0.856|3.575|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 10 mg vs Placebo at 54 weeks||3.575|0.856|0.1248
70949023|NCT01011868|141399400|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.423||||0.0132|TWO_SIDED|95.0|1.203|4.879|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 54 weeks||4.879|1.203|0.0132
70949024|NCT01011868|141399400|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.939||||0.0986|TWO_SIDED|95.0|0.884|4.256|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 10 mg vs Placebo at 78 weeks||4.256|0.884|0.0986
70866619|NCT02187744|141219685|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis to be tested in this study is the percentage of participants with steady state (Cycle 5) Ctrough \>20 μg/mL of PF-05280014 is non-inferior to trastuzumab-EU using a margin of -12.5%.|Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-8.02|6.49|||||Stratified analysis was based on the normal approximation to the binomial distribution, adjusting for the randomization strata of primary tumor size, estrogen receptor status and by progesterone receptor status.|||6.49|-8.02|
70866620|NCT02187744|141219685|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis to be tested in this study is the percentage of participants with steady state (Cycle 5) Ctrough \>20 μg/mL of PF-05280014 is non-inferior to trastuzumab-EU using a margin of -12.5%.|Mean Difference (Final Values)|-1.18|STANDARD_ERROR_OF_MEAN|3.78|||TWO_SIDED|95.0|-8.59|6.23|||||Unstratified analysis.|||6.23|-8.59|
70949025|NCT01011868|141399400|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.239||||0.0024|TWO_SIDED|95.0|1.518|6.911|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 78 weeks||6.911|1.518|0.0024
70949026|NCT03784820|141399401|SUPERIORITY||Odds Ratio (OR)|0.35||||0.36|TWO_SIDED|95.0|0.04|3.27||Comparison of Patients at Post (T2) \[CBT-E is the reference\]|Mixed Models Analysis|||||3.27|0.04|0.36
70949027|NCT03784820|141399401|SUPERIORITY||Odds Ratio (OR)|0.29||||0.38|TWO_SIDED|95.0|0.02|4.6||Comparison of Patients at 3 Month Fup (T3) \[CBT-E is the reference\]|Mixed Models Analysis|||||4.60|0.02|0.38
70949028|NCT03784820|141399401|SUPERIORITY||Odds Ratio (OR)|2.2||||0.54|TWO_SIDED|95.0|0.18|27.39||Comparison of Patients at 6 Month Fup (T4) \[CBT-E is the reference\]|Mixed Models Analysis|||||27.39|0.18|0.54
70949029|NCT03784820|141399402|SUPERIORITY||LS mean difference|0.51||||0.52|TWO_SIDED|95.0|-1.06|2.09||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||2.09|-1.06|0.52
70949030|NCT03784820|141399402|SUPERIORITY||LS mean difference|0.04||||0.97|TWO_SIDED|95.0|-1.99|2.07||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||2.07|-1.99|0.97
70949031|NCT03784820|141399402|SUPERIORITY||LS mean difference|0.62||||0.59|TWO_SIDED|95.0|-1.66|2.89||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||2.89|-1.66|0.59
70949032|NCT03784820|141399403|SUPERIORITY||LS mean difference|0.05||||0.86|TWO_SIDED|95.0|-0.45|0.54||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||0.54|-0.45|0.86
71140968|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|1.83||||0.2063|TWO_SIDED|95.0|0.72|4.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.67|0.72|0.2063
71140969|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0383|TWO_SIDED|95.0|1.06|6.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.92|1.06|0.0383
70949033|NCT03784820|141399403|SUPERIORITY||LS mean difference|0.3||||0.44|TWO_SIDED|95.0|-0.46|1.06||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||1.06|-0.46|0.44
70949034|NCT03784820|141399403|SUPERIORITY||LS mean difference|0.31||||0.36|TWO_SIDED|95.0|-0.36|0.98||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||0.98|-0.36|0.36
70949035|NCT03784820|141399404|SUPERIORITY||LS mean difference|2.47||||0.33|TWO_SIDED|95.0|-2.54|7.49||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||7.49|-2.54|0.33
70949036|NCT03784820|141399404|SUPERIORITY||LS mean difference|2.18||||0.46|TWO_SIDED|95.0|-3.59|7.95||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||7.95|-3.59|0.46
70949037|NCT03784820|141399404|SUPERIORITY||LS mean difference|3.83||||0.27|TWO_SIDED|95.0|-2.94|10.6||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||10.60|-2.94|0.27
70949038|NCT03784820|141399405|SUPERIORITY||LS mean difference|1.06||||0.62|TWO_SIDED|95.0|-3.14|5.25||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||5.25|-3.14|0.62
71140970|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|3.46||||0.0118|TWO_SIDED|95.0|1.32|9.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||9.10|1.32|0.0118
70949039|NCT03784820|141399405|SUPERIORITY||LS mean difference|1.83||||0.54|TWO_SIDED|95.0|-4.07|7.73||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||7.73|-4.07|0.54
70949040|NCT03784820|141399406|SUPERIORITY||LS mean difference|4.8||||0.1|TWO_SIDED|95.0|-0.91|10.51||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||10.51|-0.91|0.10
70949041|NCT03784820|141399406|SUPERIORITY||LS mean difference|1.08||||0.76|TWO_SIDED|95.0|-5.97|8.13||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||8.13|-5.97|0.76
70949042|NCT03784820|141399406|SUPERIORITY||LS mean difference|3.26||||0.23|TWO_SIDED|95.0|-2.03|8.55||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||8.55|-2.03|0.23
70949043|NCT03784820|141399406|SUPERIORITY||LS mean difference|-0.25||||0.94|TWO_SIDED|95.0|-6.63|6.14||Comparison of Partners at Post (T2)|Mixed Models Analysis|||||6.14|-6.63|0.94
70949044|NCT03784820|141399406|SUPERIORITY||LS mean difference|-1.46||||0.68|TWO_SIDED|95.0|-8.38|5.46||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||5.46|-8.38|0.68
70949045|NCT03784820|141399406|SUPERIORITY||LS mean difference|-0.61||||0.89|TWO_SIDED|95.0|-9.06|7.84||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||7.84|-9.06|0.89
70949046|NCT03784820|141399407|SUPERIORITY||LS mean difference|-0.41||||0.91|TWO_SIDED|95.0|-7.61|6.79||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||6.79|-7.61|0.91
70949047|NCT03784820|141399407|SUPERIORITY||LS mean difference|4.72||||0.2|TWO_SIDED|95.0|-2.49|11.93||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||11.93|-2.49|0.20
70949048|NCT03784820|141399407|SUPERIORITY||LS mean difference|4.78||||0.14|TWO_SIDED|95.0|-1.63|11.2||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||11.20|-1.63|0.14
70949049|NCT03784820|141399407|SUPERIORITY||LS mean difference|3.86||||0.25|TWO_SIDED|95.0|-2.76|10.49||Comparison of Partners at Post (T2)|Mixed Models Analysis|||||10.49|-2.76|0.25
70949050|NCT03784820|141399407|SUPERIORITY||LS mean difference|4.22||||0.14|TWO_SIDED|95.0|-1.45|9.89||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||9.89|-1.45|0.14
70949051|NCT03784820|141399407|SUPERIORITY||LS mean difference|3.15||||0.28|TWO_SIDED|95.0|-2.58|8.87||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||8.87|-2.58|0.28
71140971|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|2.96||||0.0314|TWO_SIDED|95.0|1.1|7.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||7.97|1.10|0.0314
71140972|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|6.8||||0.001|TWO_SIDED|95.0|2.17|21.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||21.34|2.17|0.0010
71140973|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|2.24||||0.0956|TWO_SIDED|95.0|0.87|5.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.80|0.87|0.0956
71140974|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|4.8||||0.0027|TWO_SIDED|95.0|1.72|13.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||13.40|1.72|0.0027
71140975|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|2.41||||0.066|TWO_SIDED|95.0|0.94|6.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.14|0.94|0.0660
71140976|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|2.32||||0.0853|TWO_SIDED|95.0|0.89|6.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.05|0.89|0.0853
71140977|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|3.49||||0.0159|TWO_SIDED|95.0|1.26|9.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.62|1.26|0.0159
71140978|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|3.27||||0.0303|TWO_SIDED|95.0|1.12|9.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.53|1.12|0.0303
71140979|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|4.84||||0.0071|TWO_SIDED|95.0|1.54|15.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||15.28|1.54|0.0071
71140980|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0621|TWO_SIDED|95.0|0.95|7.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.09|0.95|0.0621
71140981|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|4.2||||0.0081|TWO_SIDED|95.0|1.45|12.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||12.15|1.45|0.0081
71140982|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0533|TWO_SIDED|95.0|0.99|7.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.09|0.99|0.0533
71140983|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|1.71||||0.2666|TWO_SIDED|95.0|0.66|4.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.42|0.66|0.2666
71140984|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|2.44||||0.0754|TWO_SIDED|95.0|0.91|6.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.52|0.91|0.0754
71140985|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|3.27||||0.0313|TWO_SIDED|95.0|1.11|9.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||9.64|1.11|0.0313
71140986|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|5.76||||0.0056|TWO_SIDED|95.0|1.67|19.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||19.88|1.67|0.0056
70949052|NCT03784820|141399408|SUPERIORITY||LS mean difference|1.73||||0.85|TWO_SIDED|95.0|-16.73|20.19||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||20.19|-16.73|0.85
70949053|NCT03784820|141399408|SUPERIORITY||LS mean difference|7.94||||0.47|TWO_SIDED|95.0|-13.59|29.48||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||29.48|-13.59|0.47
70949054|NCT03784820|141399408|SUPERIORITY||LS mean difference|9.79||||0.37|TWO_SIDED|95.0|-11.5|31.08||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||31.08|-11.50|0.37
70949055|NCT03784820|141399408|SUPERIORITY||LS mean difference|0.36||||0.97|TWO_SIDED|95.0|-19.31|20.03||Comparison of Partners at Post (T2)|Mixed Models Analysis|||||20.03|-19.31|0.97
70866621|NCT02187744|141219687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.81|STANDARD_ERROR_OF_MEAN|7.03|||TWO_SIDED|95.0|-16.58|10.96|||||Stratified analysis was based on the normal approximation to the binomial distribution, adjusting for the randomization strata of primary tumor size, estrogen receptor status and by progesterone receptor status.|||10.96|-16.58|
70866622|NCT02187744|141219687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|7.35|||TWO_SIDED|95.0|-17.4|11.4|||||Unstratified analysis.|||11.40|-17.40|
70866623|NCT02187744|141219688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.96|STANDARD_ERROR_OF_MEAN|5.09|||TWO_SIDED|95.0|-4.01|15.94|||||Stratified analysis was based on the normal approximation to the binomial distribution, adjusting for the randomization strata of primary tumor size, estrogen receptor status and by progesterone receptor status.|||15.94|-4.01|
70949056|NCT03784820|141399408|SUPERIORITY||LS mean difference|-5.88||||0.52|TWO_SIDED|95.0|-23.85|12.09||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||12.09|-23.85|0.52
70866624|NCT02187744|141219688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1|STANDARD_ERROR_OF_MEAN|5.19|||TWO_SIDED|95.0|-4.08|16.27|||||Unstratified analysis.|||16.27|-4.08|
70866625|NCT00134030|141219691|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.214|TWO_SIDED|95.0|0.61|1.12|||Log Rank|||||1.12|0.61|0.214
70866626|NCT00134030|141219691|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.86|TWO_SIDED|95.0|0.78|1.23|||Log Rank|||||1.23|0.78|0.86
70866627|NCT00134030|141219691|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.69|TWO_SIDED|95.0|-3.3|4.9|||Difference in RMST|||Secondary RMST analysis performed in poor response group, due to evidence of non-proportional hazards.||4.9|-3.3|0.69
70866628|NCT00134030|141219692|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.804|TWO_SIDED|95.0|0.69|1.33|||Log Rank|||||1.33|0.69|0.804
70866629|NCT00134030|141219692|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.674|TWO_SIDED|95.0|0.81|1.39|||Log Rank|||||1.39|0.81|0.674
70866630|NCT01435603|141219698|SUPERIORITY||Slope|-1.273||||0.017|TWO_SIDED||||||Regression, Linear|||||||0.017
70949057|NCT03784820|141399408|SUPERIORITY||LS mean difference|-3.55||||0.68|TWO_SIDED|95.0|-20.33|13.23||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||13.23|-20.33|0.68
71140987|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|2.58||||0.0736|TWO_SIDED|95.0|0.91|7.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.28|0.91|0.0736
71140988|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|3.51||||0.0184|TWO_SIDED|95.0|1.24|10.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||10.00|1.24|0.0184
71140989|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|2.18||||0.1187|TWO_SIDED|95.0|0.82|5.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.81|0.82|0.1187
71140990|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|3.8||||0.0299|TWO_SIDED|95.0|1.14|12.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||12.69|1.14|0.0299
71140991|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|1.4||||0.5989|TWO_SIDED|95.0|0.4|4.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||4.89|0.40|0.5989
70866631|NCT01999868|141219725|SUPERIORITY|||||||0.41||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 88. This interval corresponds to the time from randomization until the end of the study. This analysis is the primary analysis of the primary endpoint.||||0.41
70866632|NCT01999868|141219725|SUPERIORITY|||||||0.013||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.||||0.013
70866633|NCT01999868|141219725|SUPERIORITY|||||||0.5||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 28 to 88. This interval corresponds to the time from the last scheduled dose of ustekinumab or ustekinumab placebo until the end of the study.||||0.50
70949058|NCT03784820|141399409|SUPERIORITY||LS mean difference|-0.27||||0.91|TWO_SIDED|95.0|-5.02|4.47||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||4.47|-5.02|0.91
70949059|NCT03784820|141399409|SUPERIORITY||LS mean difference|4.73||||0.07|TWO_SIDED|95.0|-0.36|9.81||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||9.81|-0.36|0.07
70949060|NCT03784820|141399409|SUPERIORITY||LS mean difference|1.75||||0.65|TWO_SIDED|95.0|-5.73|9.23||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||9.23|-5.73|0.65
70949061|NCT03784820|141399409|SUPERIORITY||LS mean difference|-2.05||||0.52|TWO_SIDED|95.0|-8.21|4.12|||Mixed Models Analysis|||Comparison of Partners at Post (T2)||4.12|-8.21|0.52
70949062|NCT03784820|141399409|SUPERIORITY||LS mean difference|-6.62||||0.07|TWO_SIDED|95.0|-13.74|0.51||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||0.51|-13.74|0.07
70949063|NCT03784820|141399409|SUPERIORITY||LS mean difference|-6.64||||0.03|TWO_SIDED|95.0|-12.73|-0.56||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||-0.56|-12.73|0.03
71140992|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|2.61||||0.1337|TWO_SIDED|95.0|0.74|9.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.14|0.74|0.1337
70866634|NCT01999868|141219725|SUPERIORITY|||||||0.67||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 40 to 88. This interval corresponds to the time from the beginning of the blinded observation phase until the end of the study.||||0.67
70949064|NCT03784820|141399410|SUPERIORITY||LS mean difference|0.88||||0.9|TWO_SIDED|95.0|-13.43|15.19||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||15.19|-13.43|0.90
70949065|NCT03784820|141399410|SUPERIORITY||LS mean difference|-0.64||||0.95|TWO_SIDED|95.0|-18.95|17.66||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||17.66|-18.95|0.95
70949066|NCT03784820|141399410|SUPERIORITY||LS mean difference|1.37||||0.89|TWO_SIDED|95.0|-17.17|19.9||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||19.90|-17.17|0.89
70949067|NCT03784820|141399410|SUPERIORITY||LS mean difference|5.81||||0.39|TWO_SIDED|95.0|-7.37|18.98|||Mixed Models Analysis|||Comparison of Partners at Post (T2)||18.98|-7.37|0.39
70949068|NCT03784820|141399410|SUPERIORITY||LS mean difference|6.29||||0.36|TWO_SIDED|95.0|-7.26|19.84||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||19.84|-7.26|0.36
70949069|NCT03784820|141399410|SUPERIORITY||LS mean difference|-1.55||||0.87|TWO_SIDED|95.0|-20.0|16.91||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||16.91|-20.00|0.87
70949070|NCT03784820|141399411|SUPERIORITY||LS mean difference|0.27||||0.84|TWO_SIDED|95.0|-2.29|2.83||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||2.83|-2.29|0.84
70949071|NCT03784820|141399411|SUPERIORITY||LS mean difference|-0.82||||0.57|TWO_SIDED|95.0|-3.66|2.01||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||2.01|-3.66|0.57
70949072|NCT03784820|141399411|SUPERIORITY||LS mean difference|0.6||||0.67|TWO_SIDED|95.0|-2.15|3.35||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||3.35|-2.15|0.67
70949073|NCT03784820|141399411|SUPERIORITY||LS mean difference|0.46||||0.63|TWO_SIDED|95.0|-1.43|2.35||Comparison of Partners at Post (T2)|Mixed Models Analysis|||||2.35|-1.43|0.63
70949074|NCT03784820|141399411|SUPERIORITY||LS mean difference|1.44||||0.21|TWO_SIDED|95.0|-0.82|3.7||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||3.70|-0.82|0.21
71140993|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|1.62||||0.4605|TWO_SIDED|95.0|0.45|5.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.89|0.45|0.4605
71140994|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|4.48||||0.0188|TWO_SIDED|95.0|1.28|15.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||15.65|1.28|0.0188
71140995|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|1.44||||0.5854|TWO_SIDED|95.0|0.39|5.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.42|0.39|0.5854
71140996|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|2.32||||0.1768|TWO_SIDED|95.0|0.68|7.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.86|0.68|0.1768
71140997|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|0.89||||0.8426|TWO_SIDED|95.0|0.29|2.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.78|0.29|0.8426
71140998|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|0.54||||0.3017|TWO_SIDED|95.0|0.17|1.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.73|0.17|0.3017
71140999|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|0.72||||0.5958|TWO_SIDED|95.0|0.21|2.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.43|0.21|0.5958
70866635|NCT01999868|141219726|SUPERIORITY|||||||0.019||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 88. This interval corresponds to the time from randomization until the end of the study.||||0.019
71141000|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|0.23||||0.0515|TWO_SIDED|95.0|0.05|1.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.01|0.05|0.0515
71141001|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9734|TWO_SIDED|95.0|0.31|3.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.11|0.31|0.9734
71141002|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|0.85||||0.7969|TWO_SIDED|95.0|0.25|2.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.93|0.25|0.7969
71141003|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|0.78||||0.6637|TWO_SIDED|95.0|0.25|2.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.40|0.25|0.6637
71141004|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|1.53||||0.4921|TWO_SIDED|95.0|0.45|5.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.15|0.45|0.4921
71141005|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|1.09||||0.891|TWO_SIDED|95.0|0.33|3.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.64|0.33|0.8910
71141006|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|0.68||||0.5881|TWO_SIDED|95.0|0.16|2.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.78|0.16|0.5881
70949075|NCT03784820|141399411|SUPERIORITY||LS mean difference|1.07||||0.34|TWO_SIDED|95.0|-1.14|3.28||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||3.28|-1.14|0.34
70949076|NCT03784820|141399412|SUPERIORITY||LS mean difference|-3.42||||0.5|TWO_SIDED|95.0|-13.36|6.52||Demand/Withdraw score: Comparison of Patients at Post (T2)|Mixed Models Analysis|||||6.52|-13.36|0.50
71141007|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|0.11||||0.0523|TWO_SIDED|95.0|0.01|1.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.02|0.01|0.0523
70949077|NCT03784820|141399412|SUPERIORITY||LS mean difference|-0.47||||0.89|TWO_SIDED|95.0|-7.49|6.54||Demand/Withdraw Score: Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||6.54|-7.49|0.89
70866636|NCT01999868|141219726|SUPERIORITY|||||||0.001||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.||||0.001
70949078|NCT03784820|141399412|SUPERIORITY||LS mean difference|-0.63||||0.86|TWO_SIDED|95.0|-7.56|6.3||Demand/Withdraw Score: Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||6.30|-7.56|0.86
71141008|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|1.6||||0.4646|TWO_SIDED|95.0|0.46|5.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.61|0.46|0.4646
71141009|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|1.43||||0.5806|TWO_SIDED|95.0|0.4|5.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.14|0.40|0.5806
71141010|NCT03192176|141778530|SUPERIORITY||Odds Ratio (OR)|0.94||||0.922|TWO_SIDED|95.0|0.28|3.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.12|0.28|0.9220
71141011|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|4.45||||0.1933|TWO_SIDED|95.0|0.47|42.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||42.25|0.47|0.1933
71141012|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|5.61||||0.124|TWO_SIDED|95.0|0.62|50.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||50.44|0.62|0.1240
71141013|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|14.16||||0.014|TWO_SIDED|95.0|1.71|117.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||117.2|1.71|0.0140
71141014|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|17.5||||0.0075|TWO_SIDED|95.0|2.15|142.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||142.7|2.15|0.0075
71141015|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|1.98||||0.5853|TWO_SIDED|95.0|0.17|22.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||22.96|0.17|0.5853
71141016|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|5.0||||0.1596|TWO_SIDED|95.0|0.53|47.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||47.05|0.53|0.1596
71141017|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|6.48||||0.0908|TWO_SIDED|95.0|0.74|56.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||56.51|0.74|0.0908
71141018|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|2.97||||0.1318|TWO_SIDED|95.0|0.72|12.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.19|0.72|0.1318
71141019|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|5.99||||0.0093|TWO_SIDED|95.0|1.56|23.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||23.04|1.56|0.0093
71141020|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|10.13||||0.0006|TWO_SIDED|95.0|2.69|38.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||38.22|2.69|0.0006
71141021|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|15.63|||<|0.0001|TWO_SIDED|95.0|4.11|59.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||59.40|4.11|<0.0001
70949079|NCT03784820|141399412|SUPERIORITY||LS mean difference|2.55||||0.25|TWO_SIDED|95.0|-1.83|6.93||Constructive Communication Score: Comparison of Patients at Post (T2)|Mixed Models Analysis|||||6.93|-1.83|0.25
70949080|NCT03784820|141399412|SUPERIORITY||LS mean difference|2.05||||0.56|TWO_SIDED|95.0|-4.83|8.92||Constructive Communication Score: Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||8.92|-4.83|0.56
70949081|NCT03784820|141399412|SUPERIORITY||LS mean difference|3.13||||0.34|TWO_SIDED|95.0|-3.27|9.54||Constructive Communication Score: Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||9.54|-3.27|0.34
70949082|NCT03784820|141399412|SUPERIORITY||LS mean difference|-10.24||||0.02|TWO_SIDED|95.0|-19.05|-1.42||Demand/Withdraw score: Comparison of Partners at Post (T2)|Mixed Models Analysis|||||-1.42|-19.05|0.02
70949083|NCT03784820|141399412|SUPERIORITY||LS mean difference|-0.12||||0.98|TWO_SIDED|95.0|-8.18|7.95||Demand/Withdraw score: Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||7.95|-8.18|0.98
70949084|NCT03784820|141399412|SUPERIORITY||LS mean difference|-2.2||||0.59|TWO_SIDED|95.0|-10.1|5.7||Demand/Withdraw score: Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||5.70|-10.10|0.59
70949085|NCT03784820|141399412|SUPERIORITY||LS mean difference|2.41||||0.16|TWO_SIDED|95.0|-0.99|5.82||Constructive Communication Score: Comparison of Partners at Post (T2)|Mixed Models Analysis|||||5.82|-0.99|0.16
70949086|NCT03784820|141399412|SUPERIORITY||LS mean difference|3.94||||0.12|TWO_SIDED|95.0|-1.05|8.93||Constructive Communication Score: Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||8.93|-1.05|0.12
70949087|NCT03784820|141399412|SUPERIORITY||LS mean difference|2.26||||0.34|TWO_SIDED|95.0|-2.35|6.87||Constructive Communication Score: Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||6.87|-2.35|0.34
70949088|NCT03784820|141399413|SUPERIORITY||LS mean difference|0.09||||0.7|TWO_SIDED|95.0|-0.35|0.53||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||0.53|-0.35|0.70
70949089|NCT03784820|141399413|SUPERIORITY||LS mean difference|-0.03||||0.9|TWO_SIDED|95.0|-0.48|0.42||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||0.42|-0.48|0.90
70949090|NCT03784820|141399413|SUPERIORITY||LS mean difference|0.25||||0.38|TWO_SIDED|95.0|-0.31|0.82||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||0.82|-0.31|0.38
70949091|NCT03784820|141399414|SUPERIORITY||LS mean difference|-0.33||||0.89|TWO_SIDED|95.0|-5.1|4.43||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||4.43|-5.10|0.89
71141022|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|2.53||||0.2054|TWO_SIDED|95.0|0.6|10.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.64|0.60|0.2054
71141023|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|2.8||||0.1592|TWO_SIDED|95.0|0.67|11.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||11.72|0.67|0.1592
70949092|NCT03784820|141399414|SUPERIORITY||LS mean difference|0.45||||0.85|TWO_SIDED|95.0|-4.14|5.04||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||5.04|-4.14|0.85
70949093|NCT03784820|141399414|SUPERIORITY||LS mean difference|-0.85||||0.72|TWO_SIDED|95.0|-5.54|3.85||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||3.85|-5.54|0.72
70949094|NCT03784820|141399414|SUPERIORITY||LS mean difference|-3.05||||0.29|TWO_SIDED|95.0|-8.73|2.63||Comparison of Partners at Post (T2)|Mixed Models Analysis|||||2.63|-8.73|0.29
70949095|NCT03784820|141399414|SUPERIORITY||LS mean difference|-4.69||||0.08|TWO_SIDED|95.0|-9.9|0.51||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||0.51|-9.90|0.08
70949096|NCT03784820|141399414|SUPERIORITY||LS mean difference|-3.29||||0.19|TWO_SIDED|95.0|-8.23|1.65||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||1.65|-8.23|0.19
71141024|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|6.31||||0.007|TWO_SIDED|95.0|1.66|24.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||24.07|1.66|0.0070
70866637|NCT01999868|141219726|SUPERIORITY|||||||0.018||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 28 to 88. This interval corresponds to the time from the last scheduled dose of ustekinumab or ustekinumab placebo until the end of the study.||||0.018
70949097|NCT03784820|141399415|SUPERIORITY||LS mean difference|-1.2||||0.41|TWO_SIDED|95.0|-4.08|1.67||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||1.67|-4.08|0.41
70949098|NCT03784820|141399415|SUPERIORITY||LS mean difference|0.33||||0.84|TWO_SIDED|95.0|-2.87|3.54||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||3.54|-2.87|0.84
70949099|NCT03784820|141399415|SUPERIORITY||LS mean difference|-1.21||||0.5|TWO_SIDED|95.0|-4.76|2.34||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||2.34|-4.76|0.50
70949100|NCT03784820|141399415|SUPERIORITY||LS mean difference|-1.09||||0.52|TWO_SIDED|95.0|-4.43|2.24||Comparison of Partners at Post (T2)|Mixed Models Analysis|||||2.24|-4.43|0.52
70949101|NCT03784820|141399415|SUPERIORITY||LS mean difference|-1.38||||0.3|TWO_SIDED|95.0|-3.96|1.21||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||1.21|-3.96|0.30
70949102|NCT03784820|141399415|SUPERIORITY||LS mean difference|-2.52||||0.03|TWO_SIDED|95.0|-4.78|-0.25||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||-0.25|-4.78|0.03
70949103|NCT03784820|141399416|SUPERIORITY||Mean Difference (Final Values)|0.53||||0.79|TWO_SIDED|95.0|-3.66|4.72||Comparison of Patients at Post (T2)|t-test, 2 sided|||||4.72|-3.66|0.79
70949104|NCT00658606|141399421|SUPERIORITY_OR_OTHER|||||||0.032||95.0||||No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.032
70949105|NCT00658606|141399422|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||No adjustments were made to multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.037
70949106|NCT00658606|141399423|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||No adjustments were made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Statistical Analysis applies to 'Change from Baseline'||||0.001
70949107|NCT00658606|141399424|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||Results were adjusted for use of concomitant psoriasis treatment.|ANOVA|||Statistical Analysis applies to 'Change from Baseline'||||0.382
70949108|NCT00658606|141399425|SUPERIORITY_OR_OTHER|||||||0.052||95.0||||No adjustments were made for multiple comparisons.|Fisher Exact|||Statistical Analysis applies to 'Clear or Almost Clear = Yes'||||0.052
70949109|NCT00658606|141399426|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||No adjustments were made for multiple comparisons.|Fisher Exact|||Statistical Analysis applies to 'Clear or Almost Clear = Yes'||||0.026
70949110|NCT00658606|141399427|SUPERIORITY_OR_OTHER|||||||0.147||95.0||||No adjustments were made for multiple comparisons.|Fisher Exact|||Statistical Analysis applies to 'PASI 90 = Yes'||||0.147
70866638|NCT01999868|141219726|SUPERIORITY|||||||0.07||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 40 to 88. This interval corresponds to the time from the beginning of the blinded observation phase until the end of the study.||||0.07
70866639|NCT01999868|141219727|SUPERIORITY|||||||0.16||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 88. This interval corresponds to the time from randomization until the end of the study.||||0.16
70866640|NCT01999868|141219727|SUPERIORITY|||||||0.002||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.||||0.002
70866641|NCT01999868|141219727|SUPERIORITY|||||||0.23||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 28 to 88. This interval corresponds to the time from the last scheduled dose of ustekinumab or ustekinumab placebo until the end of the study.||||0.23
70866642|NCT01999868|141219727|SUPERIORITY|||||||0.43||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 40 to 88. This interval corresponds to the time from the beginning of the blinded observation phase until the end of the study.||||0.43
70866643|NCT01999868|141219728|SUPERIORITY|||||||0.06||||||Two-sided test.|Grouped survival analysis|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 88. This interval corresponds to the time from randomization until the end of the study.||||0.06
70866644|NCT01999868|141219728|SUPERIORITY|||||||0.008||||||Two-sided test.|Grouped survival analysis|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.||||0.008
70866645|NCT01999868|141219729|SUPERIORITY|||||||0.005||||||Two-sided test.|Grouped survival analysis|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 88. This interval corresponds to the time from randomization until the end of the study.||||0.005
70949111|NCT00658606|141399428|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||No adjustments were made for multiple comparisons.|Log Rank|||||||0.566
71141025|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|3.39||||0.0392|TWO_SIDED|95.0|1.06|10.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.85|1.06|0.0392
70866646|NCT01999868|141219729|SUPERIORITY|||||||0.001||||||Two-sided test.|Grouped survival analysis|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.||||0.001
70866647|NCT01999868|141219730|SUPERIORITY|||||||0.013||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 40||||0.013
70866648|NCT01999868|141219730|SUPERIORITY|||||||0.95|||||||Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 88||||0.95
70949112|NCT00658606|141399429|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||No adjustments were made for multiple comparisons.|Log Rank|||||||0.001
70866649|NCT01999868|141219731|SUPERIORITY|||||||0.18||||||Two-sided test.|ANCOVA|Randomization stratum (PASI score at week 0: 12-20 or \>20), baseline DLQI, and pre-screening disease duration, centered on the median, are covariates.||Week 12 to 40||||0.18
70949113|NCT00658606|141399430|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||No adjustments were made for multiple comparisons.|Log Rank|||||||0.007
70949114|NCT00658606|141399431|SUPERIORITY_OR_OTHER|||||||0.539||95.0||||Results were adjusted for use of concomitant psoriasis treatment.|ANOVA|||Statistical Analysis applies to 'Change from Baseline'||||0.539
70866650|NCT01999868|141219731|SUPERIORITY|||||||0.045||||||Two-sided test.|ANCOVA|Randomization (PASI score week 0:12-20 or \>20), DLQI score at baseline, duration of disease prior to screening, centered about median, are covariates||Week 12 to 88||||0.045
70866651|NCT00310401|141219736|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||Paired T Test|||Paired T Test was used to compare the change in PaO2/FiO2 ratio from enrollment to procurement between albuterol and saline treated donors||||0.98
70866652|NCT01682954|141219741|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||||||<0.0001
70866653|NCT01682954|141219742|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||||||<0.0001
70866654|NCT01757535|141219749|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0009|TWO_SIDED|95.0|0.55|0.86||The p-value is 2-sided from a log-rank test stratified by age, cytogenetic risk category, and received consolidation therapy or not.|Log Rank||The hazard ratio is from a Cox proportional hazards model stratified by age, cytogenetic risk category, and received consolidation therapy or not.||The confidence interval (CI) for the difference was derived using Kosorok's method.|0.86|0.55|0.0009
70949115|NCT06314438|141399433|EQUIVALENCE|paired samples t test with significance set at 0.05 p value||||||0.34|||||||t-test, 2 sided|||||||0.34
70949116|NCT06314438|141399434|EQUIVALENCE|paired samples t test with significance level at 0.05||||||0.05|||||||t-test, 2 sided|||||||0.05
70949117|NCT06314438|141399435|EQUIVALENCE|paired samples t test with significance set at 0.05 p value|||||<|0.01|||||||t-test, 2 sided|||||||<0.01
70949118|NCT03170518|141399443|SUPERIORITY|Imputed datasets were analyzed using analysis of covariance (ANCOVA) with terms for treatment, stratification factors (antihyperglycemic agent background and age group), and baseline HbA1c.|Least square mean difference|-0.76|||=|0.002|TWO_SIDED|95.0|-1.25|-0.27|||ANCOVA|||||-0.27|-1.25|= 0.002
70949119|NCT02559310|141399504|NON_INFERIORITY|Non-inferiority Margin = 12.5%.|Treatment Difference (Lef - Mox)|-2.9|||||TWO_SIDED|95.0|-8.5|2.8|||||Difference in percentage of Responders for ECR (Lefamulin - Moxifloxacin). CI computed using continuity-corrected Z-statistic.|||2.8|-8.5|
71141026|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|4.49||||0.0096|TWO_SIDED|95.0|1.44|13.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||13.96|1.44|0.0096
71141027|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|10.11|||<|0.0001|TWO_SIDED|95.0|3.28|31.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||31.16|3.28|<0.0001
71141028|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|11.76|||<|0.0001|TWO_SIDED|95.0|3.75|36.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||36.90|3.75|<0.0001
71141029|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|2.11||||0.2217|TWO_SIDED|95.0|0.64|7.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.03|0.64|0.2217
71141030|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|4.26||||0.0131|TWO_SIDED|95.0|1.36|13.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||13.38|1.36|0.0131
71141031|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|5.39||||0.0031|TWO_SIDED|95.0|1.76|16.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||16.46|1.76|0.0031
71141032|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|2.15||||0.1485|TWO_SIDED|95.0|0.76|6.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.10|0.76|0.1485
71141033|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|3.54||||0.0128|TWO_SIDED|95.0|1.31|9.56||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||9.56|1.31|0.0128
71141034|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|6.5||||0.0003|TWO_SIDED|95.0|2.37|17.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||17.81|2.37|0.0003
71141035|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|6.42||||0.0003|TWO_SIDED|95.0|2.32|17.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||17.77|2.32|0.0003
71141036|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|1.87||||0.2354|TWO_SIDED|95.0|0.67|5.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.26|0.67|0.2354
71141037|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0894|TWO_SIDED|95.0|0.87|6.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.65|0.87|0.0894
71141038|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|3.23||||0.0201|TWO_SIDED|95.0|1.2|8.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.67|1.20|0.0201
70949120|NCT02559310|141399505|NON_INFERIORITY|Non-inferiority Margin = 10%.|Treatment Difference (Lef - Mox)|-2.6|||||TWO_SIDED|95.0|-8.9|3.9|||||Difference in Percentage of Success for IACR at test of cure visit (Lefamulin - Moxifloxacin). CI computed via Miettinen-Nurminen method, adjusted for prior antibiotic use \[Y vs. N\] and PORT risk class \[III vs. IV/V\], using CMH stratum weights.|||3.9|-8.9|
70949121|NCT02559310|141399505|NON_INFERIORITY|Non-Inferiority Margin = 10%|Treatment Difference (Lef - Mox)|-2.6|||||TWO_SIDED|95.0|-9.2|4.1|||||Difference in percentage of Success for IACR at test of cure visit. CI computed using continuity-corrected Z-statistic.|||4.1|-9.2|
70949122|NCT02559310|141399506|NON_INFERIORITY|Non-Inferiority Margin = 10%.|Treatment Difference|-2.5|||||TWO_SIDED|95.0|-8.4|3.4|||||Difference in percentage of success for IACR at test of cure visit (Lefamulin - Moxifloxacin). CI computed via Miettinen-Nurminen method, adjusted for prior antibiotic use \[Y vs. N\] and PORT risk class \[III vs. IV/V\], using CMH stratum weights.|||3.4|-8.4|
70949123|NCT02559310|141399506|NON_INFERIORITY|Non-Inferiority Margin = 10%|Treatment Difference (Lef - Mox)|-2.5|||||TWO_SIDED|95.0|-8.7|3.7|||||Difference in Percentage of Success for IACR at test of cure visit (Lefamulin - Moxifloxacin). CI computed using continuity-corrected Z-statistic|||3.7|-8.7|
70949124|NCT02783573|141399545|SUPERIORITY||LS Mean Difference (Final Values)|2.51|STANDARD_ERROR_OF_MEAN|1.64||0.129|TWO_SIDED|95.0|-0.752|5.776|||Mixed Models Analysis|||||5.776|-0.752|0.129
70949125|NCT02783573|141399545|SUPERIORITY||LS Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|1.76||0.903|TWO_SIDED|95.0|-3.725|3.296|||Mixed Models Analysis|||||3.296|-3.725|0.903
71141039|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|2.1||||0.1614|TWO_SIDED|95.0|0.74|5.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.94|0.74|0.1614
70949126|NCT02783573|141399546|SUPERIORITY||LS Mean Difference (Final Values)|-2.95|STANDARD_ERROR_OF_MEAN|1.78||0.1|TWO_SIDED|95.0|-6.488|0.58|||Mixed Models Analysis|||||0.580|-6.488|0.100
70949127|NCT02783573|141399546|SUPERIORITY||LS Mean Difference (Final Values)|-3.18|STANDARD_ERROR_OF_MEAN|1.86||0.092|TWO_SIDED|95.0|-6.876|0.525|||Mixed Models Analysis|||||0.525|-6.876|0.092
70949128|NCT02783573|141399547|SUPERIORITY||LS Mean Difference (Final Values)|1.23|STANDARD_ERROR_OF_MEAN|1.14||0.285|TWO_SIDED|95.0|-1.045|3.499|||Mixed Models Analysis|||||3.499|-1.045|0.285
70949129|NCT02783573|141399547|SUPERIORITY||LS Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|1.19||0.661|TWO_SIDED|95.0|-2.889|1.843|||Mixed Models Analysis|||||1.843|-2.889|0.661
70949130|NCT02783573|141399548|SUPERIORITY||LS Mean Difference (Final Values)|-4.77|STANDARD_ERROR_OF_MEAN|2.69||0.079|TWO_SIDED|95.0|-10.103|0.56|||Mixed Models Analysis|||||0.56|-10.103|0.079
70949131|NCT02783573|141399548|SUPERIORITY||LS Mean Difference (Final Values)|-1.97|STANDARD_ERROR_OF_MEAN|2.82||0.486|TWO_SIDED|95.0|-7.573|3.62|||Mixed Models Analysis|||||3.62|-7.573|0.486
70949132|NCT02783573|141399549|SUPERIORITY||LS Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.57||0.663|TWO_SIDED|95.0|-0.89|1.391|||Mixed Models Analysis|||||1.391|-0.890|0.663
71141040|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|3.57||||0.0123|TWO_SIDED|95.0|1.32|9.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||9.66|1.32|0.0123
71141041|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|6.08||||0.0006|TWO_SIDED|95.0|2.17|17.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||17.03|2.17|0.0006
70949133|NCT02783573|141399549|SUPERIORITY||LS Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.6||0.717|TWO_SIDED|95.0|-1.423|0.983|||Mixed Models Analysis|||||0.983|-1.423|0.717
70949134|NCT02783573|141399551|SUPERIORITY||LS Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|2.34||0.899|TWO_SIDED|95.0|-4.297|4.889|||Mixed Models Analysis|||||4.889|-4.297|0.899
70949135|NCT02783573|141399551|SUPERIORITY||LS Mean Difference (Final Values)|-3.01|STANDARD_ERROR_OF_MEAN|2.16||0.164|TWO_SIDED|95.0|-7.267|1.238|||Mixed Models Analysis|||||1.238|-7.267|0.164
71141042|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|9.82|||<|0.0001|TWO_SIDED|95.0|3.4|28.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||28.36|3.40|<0.0001
71141043|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1609|TWO_SIDED|95.0|0.75|5.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.81|0.75|0.1609
70949136|NCT02783573|141399552|SUPERIORITY||LS Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|0.82||0.126|TWO_SIDED|95.0|-2.891|0.362|||Mixed Models Analysis|||||0.362|-2.891|0.126
70949137|NCT02783573|141399552|SUPERIORITY||LS Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.86||0.862|TWO_SIDED|95.0|-1.867|1.566|||Mixed Models Analysis|||||1.566|-1.867|0.862
70949138|NCT02783573|141399553|SUPERIORITY||LS Mean Difference (Final Values)|-37.55|STANDARD_ERROR_OF_MEAN|37.49||0.343|TWO_SIDED|95.0|-122.35|47.26|||ANCOVA|||||47.26|-122.35|0.343
70949139|NCT02783573|141399553|SUPERIORITY||LS Mean Difference (Final Values)|-40.72|STANDARD_ERROR_OF_MEAN|35.12||0.276|TWO_SIDED|95.0|-120.17|38.73|||ANCOVA|||||38.73|-120.17|0.276
71141044|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|2.42||||0.093|TWO_SIDED|95.0|0.86|6.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.79|0.86|0.0930
71141045|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|4.02||||0.0063|TWO_SIDED|95.0|1.48|10.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||10.91|1.48|0.0063
71141046|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|1.76||||0.2621|TWO_SIDED|95.0|0.65|4.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||4.74|0.65|0.2621
71141047|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|3.55||||0.0092|TWO_SIDED|95.0|1.37|9.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.21|1.37|0.0092
71141048|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|5.69||||0.0007|TWO_SIDED|95.0|2.09|15.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||15.48|2.09|0.0007
71141049|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|8.85|||<|0.0001|TWO_SIDED|95.0|3.08|25.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||25.43|3.08|<0.0001
71141050|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|1.5||||0.4259|TWO_SIDED|95.0|0.55|4.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||4.08|0.55|0.4259
71141051|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|2.13||||0.1334|TWO_SIDED|95.0|0.79|5.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.74|0.79|0.1334
71141052|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|3.39||||0.012|TWO_SIDED|95.0|1.31|8.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||8.77|1.31|0.0120
71141053|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|1.84||||0.2443|TWO_SIDED|95.0|0.66|5.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.10|0.66|0.2443
71141054|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|4.6||||0.0022|TWO_SIDED|95.0|1.73|12.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||12.25|1.73|0.0022
71141055|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|6.6||||0.0004|TWO_SIDED|95.0|2.35|18.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||18.58|2.35|0.0004
71141056|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|12.17|||<|0.0001|TWO_SIDED|95.0|4.05|36.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||36.63|4.05|<0.0001
71141057|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|1.7||||0.3101|TWO_SIDED|95.0|0.61|4.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.71|0.61|0.3101
71141058|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|3.65||||0.0116|TWO_SIDED|95.0|1.34|10.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||10.00|1.34|0.0116
71141059|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|4.15||||0.0045|TWO_SIDED|95.0|1.56|11.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||11.05|1.56|0.0045
71141060|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|1.55||||0.3505|TWO_SIDED|95.0|0.62|3.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.88|0.62|0.3505
71141061|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|2.28||||0.0739|TWO_SIDED|95.0|0.92|5.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.62|0.92|0.0739
71141062|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|3.19||||0.0163|TWO_SIDED|95.0|1.24|8.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||8.20|1.24|0.0163
70949140|NCT02783573|141399554|SUPERIORITY||LS Mean Difference (Final Values)|-61.94|STANDARD_ERROR_OF_MEAN|31.3||0.079|TWO_SIDED|95.0|-132.75|8.87|||ANCOVA|||||8.87|-132.75|0.079
71141063|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|8.49||||0.0001|TWO_SIDED|95.0|2.81|25.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||25.64|2.81|0.0001
71141064|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8358|TWO_SIDED|95.0|0.35|2.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||2.35|0.35|0.8358
71141065|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|2.18||||0.1006|TWO_SIDED|95.0|0.86|5.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.52|0.86|0.1006
70866655|NCT01757535|141219750|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.52|0.8||The p-value is 2-sided from a log-rank test stratified by age, cytogenetic risk category, and received consolidation therapy or not.|Log Rank||The hazard ratio is from a Cox proportional hazards model stratified by age, cytogenetic risk category, and received consolidation therapy or not.|||0.80|0.52|< 0.0001
70949141|NCT02783573|141399554|SUPERIORITY||LS Mean Difference (Final Values)|-34.15|STANDARD_ERROR_OF_MEAN|31.27||0.303|TWO_SIDED|95.0|-104.88|36.59|||ANCOVA|||||36.59|-104.88|0.303
71141066|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|2.53||||0.0484|TWO_SIDED|95.0|1.01|6.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.34|1.01|0.0484
71141067|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|1.24||||0.6492|TWO_SIDED|95.0|0.5|3.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.08|0.50|0.6492
71141068|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|1.74||||0.223|TWO_SIDED|95.0|0.71|4.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.27|0.71|0.2230
70866656|NCT01757535|141219756|SUPERIORITY||Hazard Ratio (HR)|0.9345||||0.7522|TWO_SIDED|95.0|0.6136|1.4231||Stratification factors: • Age (at induction therapy): 55 to 64 years and ≥ 65 years • Prior history of MDS: yes/no • Cytogenetic risk (at induction therapy): intermediate-risk/poor-risk • Received consolidation therapy following induction: yes/no|Regression, Cox|||||1.4231|0.6136|0.7522
70866657|NCT05147428|141219770|SUPERIORITY||Cox Proportional Hazard|0.99||||0.76|TWO_SIDED|95.0|0.94|1.04|||Log Rank|||For the primary analysis, we combined all three targeted medication classes (antipsychotics, sedative/hypnotics, or strong anticholinergics). We calculated Kaplan-Meier curves and performed log-rank testing, and estimated hazard ratios using Cox proportional hazards modeling, censoring at death or disenrollment from the health plan, or at the end of the 6-month study observation period, whichever came first. The index date for the survival analysis was the end of the 3-month blackout period.||1.04|0.94|0.76
70866658|NCT05147428|141219771|SUPERIORITY|||||||0.33|||||||Chi-squared|||Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.||||0.33
70866659|NCT05147428|141219772|SUPERIORITY|||||||0.55|||||||Chi-squared|||Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.||||0.55
70866660|NCT05147428|141219773|SUPERIORITY|||||||0.47|||||||Chi-squared|||Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.||||0.47
70866661|NCT05147428|141219774|SUPERIORITY|||||||0.66|||||||Log Rank|||||||0.66
70866662|NCT05147428|141219776|SUPERIORITY|||||||0.19|||||||Chi-squared|||Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.||||0.19
70949142|NCT02783573|141399555|SUPERIORITY||LS Mean Difference (Final Values)|16.32|STANDARD_ERROR_OF_MEAN|14.29||0.283|TWO_SIDED|95.0|-16.015|48.659|||ANCOVA|||||48.659|-16.015|0.283
70949143|NCT02783573|141399555|SUPERIORITY||LS Mean Difference (Final Values)|-13.05|STANDARD_ERROR_OF_MEAN|13.21||0.349|TWO_SIDED|95.0|-42.929|16.82|||ANCOVA|||||16.820|-42.929|0.349
71141069|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|3.43||||0.0126|TWO_SIDED|95.0|1.3|9.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||9.02|1.30|0.0126
70866663|NCT05147428|141219777|SUPERIORITY|||||||0.46|||||||Chi-squared|||Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.||||0.46
70949144|NCT02783573|141399556|SUPERIORITY||LS Mean Difference (Final Values)|1.59|STANDARD_ERROR_OF_MEAN|2.23||0.494|TWO_SIDED|95.0|-3.457|6.64|||ANCOVA|||||6.640|-3.457|0.494
70866664|NCT05147428|141219778|SUPERIORITY|||||||0.79|||||||Chi-squared|||Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.||||0.79
70866665|NCT04680052|141219780|SUPERIORITY||Hazard Ratio (HR)|0.434|||<|0.0001|TWO_SIDED|95.0|0.324|0.58|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.580|0.324|<0.0001
70866666|NCT04680052|141219782|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.383|0.653|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.653|0.383|<0.0001
70866667|NCT04680052|141219783|SUPERIORITY||Odds Ratio (OR)|1.5||||0.0286|TWO_SIDED|95.0|1.04|2.13|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||2.13|1.04|0.0286
70866668|NCT04680052|141219785|SUPERIORITY||Hazard Ratio (HR)|0.587||||0.1061|TWO_SIDED|95.0|0.306|1.128|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||1.128|0.306|0.1061
70949145|NCT02783573|141399556|SUPERIORITY||LS Mean Difference (Final Values)|-2.13|STANDARD_ERROR_OF_MEAN|2.04||0.323|TWO_SIDED|95.0|-6.743|2.481|||ANCOVA|||||2.481|-6.743|0.323
70949146|NCT02783573|141399557|SUPERIORITY||LS Mean Difference (Final Values)|2.22|STANDARD_ERROR_OF_MEAN|13.76||0.873|TWO_SIDED|95.0|-26.569|31.017|||ANCOVA|||||31.017|-26.569|0.873
70949147|NCT02783573|141399557|SUPERIORITY||LS Mean Difference (Final Values)|-15.2|STANDARD_ERROR_OF_MEAN|15.43||0.337|TWO_SIDED|95.0|-47.488|17.096|||ANCOVA|||||17.096|-47.488|0.337
70866669|NCT04680052|141219786|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|1.5||||0.0221|TWO_SIDED|95.0|1.06|2.03|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||2.03|1.06|0.0221
70866670|NCT04680052|141219787|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|1.4||||0.4093|TWO_SIDED|95.0|0.61|3.33|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||3.33|0.61|0.4093
70949148|NCT02783573|141399558|SUPERIORITY||LS Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.927|TWO_SIDED|95.0|-0.015|0.017|||ANCOVA|||||0.017|-0.015|0.927
70949149|NCT02783573|141399558|SUPERIORITY||LS Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.93|TWO_SIDED|95.0|-0.015|0.017|||ANCOVA|||||0.017|-0.015|0.930
70949150|NCT02783573|141399559|SUPERIORITY||LS Mean Difference (Final Values)|-1.62|STANDARD_ERROR_OF_MEAN|1.06||0.127|TWO_SIDED|95.0|-3.708|0.464|||ANCOVA|||||0.464|-3.708|0.127
70949151|NCT02783573|141399559|SUPERIORITY||LS Mean Difference (Final Values)|-3.08|STANDARD_ERROR_OF_MEAN|1.06||0.004|TWO_SIDED|95.0|-5.172|-0.991|||ANCOVA|||||-0.991|-5.172|0.004
70949152|NCT00159263|141399562|OTHER|Friedman ANOVA followed Dunn's pairwise comparisons||||||0.04|||||||ANOVA|||||||0.04
70949153|NCT00159263|141399563|OTHER|Friedman Anova||||||0.01|||||||ANOVA|||||||0.01
70949154|NCT00159263|141399564|OTHER|Friedman Anova||||||0.04|||||||ANOVA|||||||0.04
70949155|NCT01012245|141399565|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.2|STANDARD_DEVIATION|3.4||||95.0|17.2|17.3||||||IOP 1 year (n=11602)||17.3|17.2|
70949156|NCT01012245|141399565|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.9|STANDARD_DEVIATION|2.9||||95.0|16.8|17.0||||||IOP 1 year (n=4450)||17.0|16.8|
71141070|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|5.56||||0.0014|TWO_SIDED|95.0|1.94|15.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||15.98|1.94|0.0014
71141071|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|0.7||||0.4713|TWO_SIDED|95.0|0.27|1.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||1.83|0.27|0.4713
70866671|NCT04680052|141219788|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|1.5||||0.2874|TWO_SIDED|95.0|0.69|3.47|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||3.47|0.69|0.2874
70866672|NCT04680052|141219789|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|2.0||||0.0014|TWO_SIDED|95.0|1.3|3.02|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||3.02|1.30|0.0014
70866673|NCT04680052|141219790|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|1.9||||0.0009|TWO_SIDED|95.0|1.29|2.74|||Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||2.74|1.29|0.0009
70949157|NCT01012245|141399565|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.3|STANDARD_DEVIATION|2.2||||95.0|17.1|17.5||||||IOP 1 year (n=357)||17.5|17.1|
71141072|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|2.02||||0.1397|TWO_SIDED|95.0|0.79|5.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.12|0.79|0.1397
71141073|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|1.75||||0.2272|TWO_SIDED|95.0|0.71|4.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.34|0.71|0.2272
70949158|NCT01012245|141399565|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.9|STANDARD_DEVIATION|3.2||||95.0|16.4|17.3||||||IOP 1 year (n=220)||17.3|16.4|
70949159|NCT01012245|141399565|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.6|STANDARD_DEVIATION|4.1||||95.0|17.5|17.8||||||IOP 1 year (n=3277)||17.8|17.5|
70866674|NCT04680052|141219792|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|0.473|||<|0.0001|TWO_SIDED|95.0|0.33|0.678|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.678|0.330|<0.0001
70866675|NCT04680052|141219794|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|0.55||||0.0003|TWO_SIDED|95.0|0.397|0.763|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.763|0.397|0.0003
70949160|NCT01012245|141399565|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.0|STANDARD_DEVIATION|3.4||||95.0|17.0|17.1||||||IOP 2 years (n=8051)||17.1|17.0|
70949161|NCT01012245|141399565|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.8|STANDARD_DEVIATION|2.9||||95.0|16.7|16.9||||||IOP 2 years (n=2808)||16.9|16.7|
70949162|NCT01012245|141399565|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.2|STANDARD_DEVIATION|1.8||||95.0|17.0|17.5||||||IOP 2 years (n=175)||17.5|17.0|
70949163|NCT01012245|141399565|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.6|STANDARD_DEVIATION|2.8||||95.0|15.9|17.2||||||IOP 2 years (n=83)||17.2|15.9|
70949164|NCT01012245|141399565|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.1|STANDARD_DEVIATION|3.7||||95.0|16.9|17.2||||||IOP 2 years (n=2002)||17.2|16.9|
70949165|NCT01012245|141399565|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.0|STANDARD_DEVIATION|3.4||||95.0|16.9|17.1||||||IOP 3 years (n=5469)||17.1|16.9|
70866676|NCT04680052|141219796|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|0.85||||0.5837|TWO_SIDED|95.0|0.476|1.519|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||1.519|0.476|0.5837
70949166|NCT01012245|141399565|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.8|STANDARD_DEVIATION|3.2||||95.0|16.7|17.0||||||IOP 3 years (n=1932)||17.0|16.7|
70949167|NCT01012245|141399565|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.5|STANDARD_DEVIATION|2.5||||95.0|16.9|18.1||||||IOP 3 years (n=64)||18.1|16.9|
70949168|NCT01012245|141399565|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.5|STANDARD_DEVIATION|2.8||||95.0|15.7|17.4||||||IOP 3 years (n=44)||17.4|15.7|
70949169|NCT01012245|141399565|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.9|STANDARD_DEVIATION|3.6||||95.0|16.7|17.1||||||IOP 3 years (n=1251)||17.1|16.7|
70949170|NCT01012245|141399567|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.46|STANDARD_DEVIATION|0.25||||95.0|0.46|0.47||||||Vertical C/D ratio 1 year (n=11966)||0.47|0.46|
70949171|NCT01012245|141399567|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.44|STANDARD_DEVIATION|0.24||||95.0|0.43|0.44||||||Vertical C/D ratio 1 year (n=4944)||0.44|0.43|
70949172|NCT01012245|141399567|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.39|STANDARD_DEVIATION|0.19||||95.0|0.35|0.43||||||Vertical C/D ratio 1 year (n=88)||0.43|0.35|
70949173|NCT01012245|141399567|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.5|STANDARD_DEVIATION|0.24||||95.0|0.47|0.53||||||Vertical C/D ratio 1 year (n=241)||0.53|0.47|
71141074|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|1.83||||0.2024|TWO_SIDED|95.0|0.72|4.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.64|0.72|0.2024
70866677|NCT04680052|141219798|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|0.407|||<|0.0001|TWO_SIDED|95.0|0.294|0.563|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.563|0.294|<0.0001
70866678|NCT04680052|141219800|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|0.481|||<|0.0001|TWO_SIDED|95.0|0.357|0.647|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.647|0.357|<0.0001
70949174|NCT01012245|141399567|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.51|STANDARD_DEVIATION|0.27||||95.0|0.5|0.52||||||Vertical C/D ratio 1 year (n=2949)||0.52|0.50|
70949175|NCT01012245|141399567|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.46|STANDARD_DEVIATION|0.25||||95.0|0.46|0.47||||||Vertical C/D ratio 2 years (n=8783)||0.47|0.46|
70949176|NCT01012245|141399567|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.43|STANDARD_DEVIATION|0.23||||95.0|0.42|0.44||||||Vertical C/D ratio 2 years (n=3396)||0.44|0.42|
70949177|NCT01012245|141399567|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.39|STANDARD_DEVIATION|0.16||||95.0|0.33|0.45||||||Vertical C/D ratio 2 years (n=31)||0.45|0.33|
70949178|NCT01012245|141399567|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.49|STANDARD_DEVIATION|0.24||||95.0|0.44|0.54||||||Vertical C/D ratio 2 years (n=95)||0.54|0.44|
70949179|NCT01012245|141399567|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.51|STANDARD_DEVIATION|0.27||||95.0|0.5|0.53||||||Vertical C/D ratio 2 years (n=1934)||0.53|0.50|
70949180|NCT01012245|141399567|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.45|STANDARD_DEVIATION|0.24||||95.0|0.44|0.45||||||Vertical C/D ratio 3 years (n=6344)||0.45|0.44|
70949181|NCT01012245|141399567|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.42|STANDARD_DEVIATION|0.22||||95.0|0.41|0.43||||||Vertical C/D ratio 3 years (n=2372)||0.43|0.41|
70949182|NCT01012245|141399567|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.33|STANDARD_DEVIATION|0.14||||95.0|0.27|0.39||||||Vertical C/D ratio 3 years (n=25)||0.39|0.27|
70949183|NCT01012245|141399567|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.47|STANDARD_DEVIATION|0.18||||95.0|0.41|0.53||||||Vertical C/D ratio 3 years (n=36)||0.53|0.41|
71141075|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|1.9||||0.1716|TWO_SIDED|95.0|0.76|4.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.79|0.76|0.1716
70866679|NCT04680052|141219801|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|2.2||||0.0003|TWO_SIDED|95.0|1.43|3.43|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||3.43|1.43|0.0003
70949184|NCT01012245|141399567|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.49|STANDARD_DEVIATION|0.26||||95.0|0.48|0.51||||||Vertical C/D ratio 3 years (n=1283)||0.51|0.48|
70949185|NCT01012245|141399568|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.45|STANDARD_DEVIATION|0.25||||95.0|0.45|0.46||||||Horizontal C/D ratio 1 year (n=11433)||0.46|0.45|
70866680|NCT04680052|141219802|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|2.0||||0.0005|TWO_SIDED|95.0|1.33|2.86|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||2.86|1.33|0.0005
70949186|NCT01012245|141399568|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.42|STANDARD_DEVIATION|0.23||||95.0|0.42|0.43||||||Horizontal C/D ratio 1 year (n=4810)||0.43|0.42|
70949187|NCT01012245|141399568|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.37|STANDARD_DEVIATION|0.19||||95.0|0.33|0.42||||||Horizontal C/D ratio 1 year (n=87)||0.42|0.33|
70949188|NCT01012245|141399568|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.5|STANDARD_DEVIATION|0.25||||95.0|0.47|0.53||||||Horizontal C/D ratio 1 year (n=232)||0.53|0.47|
70949189|NCT01012245|141399568|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.51|STANDARD_DEVIATION|0.27||||95.0|0.5|0.52||||||Horizontal C/D ratio 1 year (n=2703)||0.52|0.50|
70949190|NCT01012245|141399568|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.45|STANDARD_DEVIATION|0.25||||95.0|0.44|0.45||||||Horizontal C/D ratio 2 years (n=8427)||0.45|0.44|
70949191|NCT01012245|141399568|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.41|STANDARD_DEVIATION|0.23||||95.0|0.4|0.42||||||Horizontal C/D ratio 2 years (n=3276)||0.42|0.40|
70949192|NCT01012245|141399568|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.38|STANDARD_DEVIATION|0.19||||95.0|0.31|0.45||||||Horizontal C/D ratio 2 years (n=31)||0.45|0.31|
70949193|NCT01012245|141399568|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.5|STANDARD_DEVIATION|0.25||||95.0|0.45|0.56||||||Horizontal C/D ratio 2 years (n=92)||0.56|0.45|
70949194|NCT01012245|141399568|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.51|STANDARD_DEVIATION|0.27||||95.0|0.49|0.52||||||Horizontal C/D ratio 2 years (n=1812)||0.52|0.49|
70866681|NCT04680052|141219804|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|0.461|||<|0.0001|TWO_SIDED|95.0|0.312|0.681|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.681|0.312|<0.0001
70949195|NCT01012245|141399568|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.43|STANDARD_DEVIATION|0.24||||95.0|0.43|0.44||||||Horizontal C/D ratio 3 years (n=6102)||0.44|0.43|
70949196|NCT01012245|141399568|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.4|STANDARD_DEVIATION|0.22||||95.0|0.39|0.41||||||Horizontal C/D ratio 3 years (n=2289)||0.41|0.39|
70949197|NCT01012245|141399568|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.31|STANDARD_DEVIATION|0.15||||95.0|0.25|0.38||||||Horizontal C/D ratio 3 years (n=25)||0.38|0.25|
70949198|NCT01012245|141399568|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.49|STANDARD_DEVIATION|0.21||||95.0|0.42|0.57||||||Horizontal C/D ratio 3 years (n=35)||0.57|0.42|
70949199|NCT01012245|141399568|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.48|STANDARD_DEVIATION|0.26||||95.0|0.47|0.5||||||Horizontal C/D ratio 3 years (n=1204)||0.50|0.47|
70949200|NCT01475305|141399611|SUPERIORITY_OR_OTHER||Relative Risk|0.0|||||TWO_SIDED|95.0|0.0|2.05|||||Relative risk was calculated as the proportion of participants with RSV infection in the MEDI-557 arm divided by the proportion of participants with RSV infection in the placebo arm.|||2.05|0.00|
70949201|NCT01475305|141399612|SUPERIORITY_OR_OTHER||Relative Risk|1.0|||||TWO_SIDED|95.0|0.16|6.24|||||Relative risk was calculated as the proportion of participants with RSV infection in the MEDI-557 arm divided by the proportion of participants with RSV infection in the placebo arm.|RSV infection by quantitative real-time RT-PCR||6.24|0.16|
71141076|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|3.2||||0.0199|TWO_SIDED|95.0|1.2|8.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.51|1.20|0.0199
71141077|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|8.45||||0.0002|TWO_SIDED|95.0|2.8|25.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||25.54|2.80|0.0002
70866682|NCT04680052|141219806|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|1.192||||0.7469|TWO_SIDED|95.0|0.409|3.475|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||3.475|0.409|0.7469
70866683|NCT03320057|141219820|OTHER|We conducted multivariable logistic regression analyses using Generalized Estimating Equation (GEE) models to assess whether study implementation was associated with pharmacists' overall medication abortion knowledge. Multivariable GEE analyses included time period (baseline and endline) as the primary independent variable, adjusted for gender and years of experience, and accounted for clustering by pharmacy site and individual pharmacist.|Beta Coefficient|0.14|||<|0.05|TWO_SIDED|95.0|0.11|0.17|||Regression, Linear||Coefficients in adjusted analyses examining overall medication abortion knowledge represent the difference in mean knowledge scores between baseline and endline.|Medication abortion knowledge scores were based on a set of 15 items. We first assessed the internal consistency reliability of the 15 knowledge items and considered a Cronbach's alpha coefficient above .70 to be acceptable to examine the items as a combined score.||0.17|0.11|<0.05
70866684|NCT00717093|141219832|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39|||<|0.0001|TWO_SIDED|95.0|1.59|3.58||p-values obtained from logistic regression model including main effects of treatment and center|Regression, Logistic|Missing salivary cotinine values imputed as negative|Odds ratio obtained from logistic regression model including main effects of treatment and center|||3.58|1.59|<0.0001
70866685|NCT00717093|141219833|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.0118|TWO_SIDED|95.0|1.12|2.58||p-value obtained from a logistic regression model including the main effects of treatment and center|Regression, Logistic|Missing salivary cotinine values were imputed as negative|Odds Ratio obtained from a logistic regression model including the main effects of treatment and center|Week 26||2.58|1.12|0.0118
70866686|NCT00717093|141219834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77||||0.0063|TWO_SIDED|95.0|1.17|2.67|||Regression, Logistic|Missing salivary cotinine values were imputed as negative.||||2.67|1.17|0.0063
70866687|NCT00717093|141219835|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.28|||<|0.0001|TWO_SIDED|95.0|1.52|3.41||p-value obtained from a logistic regression model including the main effects of treatment and center|Regression, Logistic|Missing salivary cotinine was imputed as negative|Odds ratio obtained from a logistic regression model including the main effects of treatment and center|Week 12||3.41|1.52|<0.0001
70866688|NCT00717093|141219835|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.0919|TWO_SIDED|95.0|0.94|2.13||p-value obtained from a logistic regression model including the main effects of treatment and center|Regression, Logistic|Missing salivary cotinine was imputed as negative|Odds ratio obtained from a logistic regression model including the main effects of treatment and center|Week 26||2.13|0.94|0.0919
70866689|NCT01650844|141219854|OTHER|We estimated the power to detect the smallest clinically significant difference in mean SFDs post intervention between the groups, accounting for repeated measures. A sample of 400 obtains greater than 90% power to detect a difference of 0.8 SFD per 2 weeks or greater. Analyses were multivariable modified intention to treat, including all participants with post intervention data. Generalized estimating equation (GEE) models were fitted with repeated asthma outcomes.|Mean Difference (Net)|0.8|STANDARD_DEVIATION|2.8|<|0.05|TWO_SIDED|||||Analyses were multivariable modified intention to treat, including all participants with post intervention data. Generalized estimating equation (GEE) models were fitted with repeated asthma outcomes.|Regression, Linear|||||||<0.05
71141078|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|1.47||||0.4243|TWO_SIDED|95.0|0.57|3.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.77|0.57|0.4243
70866690|NCT02468674|141219862|OTHER|||||||0.759|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: SPPB total score at Week 49||||0.759
71141079|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|1.99||||0.1507|TWO_SIDED|95.0|0.78|5.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.09|0.78|0.1507
70866691|NCT02468674|141219862|OTHER|||||||0.5|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: SPPB total score at Week 49||||0.500
70866692|NCT02468674|141219862|OTHER|||||||0.144|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: SPPB total score at Week 49||||0.144
70866693|NCT02468674|141219862|OTHER|||||||0.648|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: SPPB total score at Week 49||||0.648
70866694|NCT02468674|141219862|OTHER|||||||0.929|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: SPPB total score at Week 49||||0.929
70866695|NCT02468674|141219862|OTHER|||||||0.53|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: SPPB total score at Week 49||||0.530
70866696|NCT02468674|141219863|OTHER|||||||0.839|||||||ANCOVA|Difference in the least square means (SE)||Population II: SPPB total score at Week 49||||0.839
70866697|NCT02468674|141219864|OTHER|||||||0.669|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49||||0.669
70866698|NCT02468674|141219864|OTHER|||||||0.773|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49||||0.773
70866699|NCT02468674|141219864|OTHER|||||||0.29|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49||||0.290
70949202|NCT01475305|141399612|SUPERIORITY_OR_OTHER||Relative Risk|0.0|||||TWO_SIDED|95.0|0.0|2.05|||||Relative risk was calculated as the proportion of participants with RSV infection in the MEDI-557 arm divided by the proportion of participants with RSV infection in the placebo arm.|RSV infection by DFA||2.05|0.00|
70949203|NCT01475305|141399612|SUPERIORITY_OR_OTHER||Relative Risk|1.0|||||TWO_SIDED|95.0|0.16|6.24|||||Relative risk was calculated as the proportion of participants with RSV infection in the MEDI-557 arm divided by the proportion of participants with RSV infection in the placebo arm.|RSV infection by Any Method||6.24|0.16|
70949204|NCT00132678|141399635|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||<|0.001||95.0|0.27|0.59|||Log Rank|Adjusting for country|RISPERDAL CONSTA hazard in numerator, placebo hazard in denominator.|||0.59|0.27|<0.001
70949205|NCT00132678|141399636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|STANDARD_ERROR_OF_MEAN|1.09|<|0.001||95.0|-8.08|-3.79|||ANCOVA|ANCOVA model with factors for treatment and country and double-blind baseline value as covariate.|Change in RISPERDAL CONSTA arm minus change in placebo arm.|||-3.79|-8.08|<0.001
70949206|NCT00132678|141399637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.87||0.02||95.0|-3.75|-0.32|||ANCOVA|ANCOVA model with factors for treatment and country and double-blind baseline value as covariate.|Change in RISPERDAL CONSTA arm minus change in placebo arm.|||-0.32|-3.75|0.020
70949207|NCT00953147|141399638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|||<|0.0001|TWO_SIDED|95.0|0.35|1.04||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in iTNSS with a two-sided alpha level of 0.025.||1.04|0.35|<0.0001
70949208|NCT00953147|141399638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.54||||0.0005|TWO_SIDED|95.0|0.24|0.84||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in iTNSS with a two-sided alpha level of 0.025.||0.84|0.24|0.0005
70949209|NCT00953147|141399639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58||||0.0014|TWO_SIDED|95.0|0.25|0.92|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.92|0.25|0.0014
70949210|NCT00953147|141399639|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.42||||0.0122|TWO_SIDED|95.0|0.12|0.72|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.72|0.12|0.0122
70949211|NCT00078338|141399661|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.943||||0.643|TWO_SIDED|95.0|0.74|1.21|||Cox proportional hazards model|||||1.21|0.74|0.643
70949212|NCT05146206|141399676|OTHER||||||<|0.001|||||||ANOVA|||||||<.001
70949213|NCT05146206|141399677|OTHER||||||<|0.001|||||||MANOVA|||||||<0.001
70949214|NCT02577003|141399678|SUPERIORITY||Difference in least squares means|-0.77|||<|0.001|TWO_SIDED|95.0|-0.98|-0.57|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-0.57|-0.98|<0.001
70949215|NCT02577003|141399681|SUPERIORITY||Difference in least squares means|-28.1|||<|0.001|TWO_SIDED|95.0|-34.8|-21.5|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-21.5|-34.8|<0.001
70949216|NCT02577003|141399682|SUPERIORITY||Difference in least squares means|-48.5|||<|0.001|TWO_SIDED|95.0|-59.6|-37.5|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-37.5|-59.6|<0.001
70949217|NCT02577003|141399683|SUPERIORITY||Difference in least squares means|-84.6|||<|0.001|TWO_SIDED|95.0|-102.6|-66.6|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-66.6|-102.6|<0.001
71141080|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0449|TWO_SIDED|95.0|1.02|6.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.60|1.02|0.0449
70949218|NCT02577003|141399684|SUPERIORITY||Difference in least squares means|-1.8|||<|0.001|TWO_SIDED|95.0|-2.5|-1.1|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-1.1|-2.5|<0.001
70949219|NCT01677299|141399688|SUPERIORITY_OR_OTHER||LS mean diff (Day 5 - Baseline)|-22.5|||<|0.05|TWO_SIDED|95.0|-37.0|-8.0|||Mixed Models Analysis|Change in fasting plasma glucose from Baseline to Day 5 (end of treatment) for treatment A.||||-8|-37|<0.05
70949220|NCT01677299|141399688|SUPERIORITY_OR_OTHER||LS mean diff (Day 5 - Baseline)|-20.0|||<|0.05|TWO_SIDED|95.0|-30.0|-9.0|||Mixed Models Analysis|Change in fasting plasma glucose from Baseline to Day 5 (end of treatment) for treatment B.||||-9|-30|<0.05
70949221|NCT01677299|141399688|SUPERIORITY_OR_OTHER||LS mean diff (Day 5 - Baseline)|-16.0|||<|0.05|TWO_SIDED|95.0|-24.0|-8.0|||Mixed Models Analysis|Change in fasting plasma glucose from Baseline to Day 5 (end of treatment) for treatment C.||||-8|-24|<0.05
71141081|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|1.68||||0.2759|TWO_SIDED|95.0|0.66|4.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.24|0.66|0.2759
71141082|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|1.9||||0.17|TWO_SIDED|95.0|0.76|4.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.78|0.76|0.1700
71141083|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|3.47||||0.0153|TWO_SIDED|95.0|1.27|9.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.51|1.27|0.0153
70949222|NCT01677299|141399688|SUPERIORITY_OR_OTHER||LS mean diff (Day 5 - Baseline)|-21.0|||<|0.05|TWO_SIDED|95.0|-31.0|-11.0|||Mixed Models Analysis|Change in fasting plasma glucose from Baseline to Day 5 (end of treatment) for treatment D.||||-11|-31|<0.05
70949223|NCT01677299|141399689|SUPERIORITY_OR_OTHER||Geometric LS mean ration|1.6|||<|0.05|TWO_SIDED|95.0|1.4|1.9|||Mixed Models Analysis|||||1.9|1.4|<0.05
70949224|NCT01677299|141399689|SUPERIORITY_OR_OTHER||Geo LSmean ratio of (Day 5/Baseline)|1.9|||<|0.05|TWO_SIDED|95.0|1.5|2.3|||Mixed Models Analysis|||||2.3|1.5|<0.05
70949225|NCT01677299|141399689|SUPERIORITY_OR_OTHER||Geo LSmean ratio (Day 5/Baseline)|1.7|||<|0.05|TWO_SIDED|95.0|1.4|2.0|||Mixed Models Analysis|||||2.0|1.4|<0.05
70949226|NCT01677299|141399689|SUPERIORITY_OR_OTHER||Geo LSmean ratio (Day 5/Baseline)|1.9|||<|0.05|TWO_SIDED|95.0|1.5|2.3|||Mixed Models Analysis|||||2.3|1.5|<0.05
70949227|NCT01677299|141399690|SUPERIORITY_OR_OTHER||Geo LSmean ratio (Day 5/Baseline)|1.5|||<|0.05|TWO_SIDED|95.0|1.4|1.8|||Mixed Models Analysis|||||1.8|1.4|<0.05
70949228|NCT01677299|141399690|SUPERIORITY_OR_OTHER||Geo LSmean ratio (Day 5/Baseline)|1.4|||<|0.05|TWO_SIDED|95.0|1.2|1.6|||Mixed Models Analysis|||||1.6|1.2|<0.05
70949229|NCT01677299|141399690|SUPERIORITY_OR_OTHER||Geo LSmean ratio (Day 5/Baseline)|1.5|||<|0.05|TWO_SIDED|95.0|1.3|1.6|||Mixed Models Analysis|||||1.6|1.3|<0.05
70949230|NCT01677299|141399690|SUPERIORITY_OR_OTHER||Geo LSmean ratio (Day 5/Baseline)|1.5|||<|0.05|TWO_SIDED|95.0|1.4|1.6|||Mixed Models Analysis|||||1.6|1.4|<0.05
70949231|NCT00559377|141399695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.27||||0.42|TWO_SIDED||||||Regression, Cox|||This outcome is for comparing FMISO Hypoxic Volume to overall survival||||.42
70949232|NCT00559377|141399695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.87|TWO_SIDED||||||Regression, Cox|||This outcome is for comparing FMISO T:Bmax to overall survival||||.87
70949233|NCT00559377|141399696|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.58|TWO_SIDED||||||Regression, Cox|||This outcome is for comparison of FMISO Hypoxic Volume to disease-free survival||||.58
70949234|NCT00559377|141399696|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.98|TWO_SIDED||||||Regression, Cox|||This outcome is for comarison of FMISO T:Bmax to progression-free survival||||.98
70949235|NCT00559377|141399697|SUPERIORITY_OR_OTHER||Spearman Correlation|0.004|||<|0.05|TWO_SIDED||||||Spearman Correlation|||The correlation between IHC values and FMISO uptake were analyzed using Spearman correlation where p values less than 0.05 were considered significant.||||<0.05
70949236|NCT00940875|141399701|SUPERIORITY_OR_OTHER||Difference in Response Rates|-3.3|||||TWO_SIDED|95.0|-17.5|10.9|||||The 95% CI for the difference of 2 rates was estimated using the Hauck-Anderson method.|||10.9|-17.5|
70949237|NCT00940875|141399702|SUPERIORITY_OR_OTHER|||||||0.4798|TWO_SIDED||||||Log Rank|||Difference between treatment groups in PFS||||0.4798
70866700|NCT02468674|141219864|OTHER|||||||0.766|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49||||0.766
70949238|NCT00940875|141399702|SUPERIORITY_OR_OTHER||Hazard Ratio, log|1.3||||0.4805|TWO_SIDED|95.0|0.63|2.68|||Wald Test||The hazard ratio was estimated using the Cox regression model and stratified by Eastern Cooperative Oncology Group (ECOG) Performance Status (PS), disease stage, histology, and smoking status.|||2.68|0.63|0.4805
70949239|NCT00940875|141399703|SUPERIORITY_OR_OTHER||Difference in Response Rates|-11.54|||||TWO_SIDED|95.0|-40.3|17.2|||||The 95% CI for difference of 2 rates was determined using the Hauck-Anderson method.|Week 8||17.2|-40.3|
70949240|NCT00940875|141399703|SUPERIORITY_OR_OTHER||Difference in Response Rates|-13.46|||||TWO_SIDED|95.0|-36.0|9.0|||||The 95% CI for difference of 2 rates was determined using the Hauck-Anderson method.|Week 16||9.0|-36.0|
70949241|NCT00940875|141399705|SUPERIORITY_OR_OTHER|||||||0.5393|TWO_SIDED||||||Log Rank|||Difference between treatment groups in OS||||0.5393
70949242|NCT00940875|141399705|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.5399|TWO_SIDED|95.0|0.38|1.66|||Wald Test||The hazard ratio was estimated using the Cox regression model and stratified by ECOG PS, disease stage, histology, and smoking status.|||1.66|0.38|0.5399
70949243|NCT03334253|141399713|SUPERIORITY|"The following assumptions were used in the power calculation:~* 2:1 randomization~* treatment group difference of 0.50D~* standard deviation of 0.80D~* type 1 error of 5% (2-sided)~* up to 10% loss to follow up"|Adjusted mean difference|-0.02|||||TWO_SIDED|95.0|-0.19|0.15|||||Atropine - Placebo Adjusted mean difference, adjusting for baseline refractive error, age, iris color (brown vs. not brown), and race (East Asian vs. non-East Asian).|Null Hypothesis: no difference in mean change in SER from baseline to 24 months between the atropine and placebo groups||0.15|-0.19|
70949244|NCT03334253|141399714|SUPERIORITY|"The following assumptions were used in the power calculation:~* 2:1 randomization~* treatment group difference of 0.50D~* standard deviation of 0.80D~* type 1 error of 5% (2-sided)~* up to 10% loss to follow up"|Adjusted mean difference|-0.04|||||TWO_SIDED|95.0|-0.25|0.17|||||Atropine-Placebo Adjusted mean difference, adjusting for baseline refractive error, age, iris color (brown vs. not brown), and race (East Asian vs. non-East Asian).|Null Hypothesis: no difference in mean change in SER from baseline to 24 months between the atropine and placebo groups||0.17|-0.25|
70949245|NCT00203047|141399715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.11820976||0.8023|TWO_SIDED|95.0|-0.26|0.2|||ANCOVA|||||0.20|-0.26|0.8023
70949246|NCT00340704|141399741|SUPERIORITY_OR_OTHER||Slope|1.0039|STANDARD_ERROR_OF_MEAN|0.1725||||95.0|0.6499|1.3579|||||Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error (SE) of the mean is actually SE of the slope.|Dose proportionality for Cmax,ss was explored based on the regression model.||1.3579|0.6499|
70949247|NCT00340704|141399745|SUPERIORITY_OR_OTHER||Slope|0.98|STANDARD_ERROR_OF_MEAN|0.1884||||95.0|0.5934|1.3666|||||Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of the slope.|Dose proportionality for AUCτ,ss was explored based on the regression model.||1.3666|0.5934|
70949248|NCT01299480|141399783|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB80 \[A22\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
70949249|NCT01299480|141399783|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2001 \[A56\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
70949250|NCT01299480|141399783|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2948 \[B24\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
70949251|NCT01299480|141399783|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2707 \[B44\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
70949252|NCT01299480|141399783|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB80 \[A22\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
70949253|NCT01299480|141399783|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2001 \[A56\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
70949254|NCT01299480|141399783|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2948 \[B24\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
70949255|NCT01299480|141399783|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2707 \[B44\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
70949256|NCT01299480|141399785|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB80 \[A22\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
70949257|NCT01299480|141399785|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2001 \[A56\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
70949258|NCT01299480|141399785|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2948 \[B24\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
70949259|NCT01299480|141399785|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2707 \[B44\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
71141084|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|6.04||||0.0009|TWO_SIDED|95.0|2.08|17.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||17.53|2.08|0.0009
71141085|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|1.27||||0.6228|TWO_SIDED|95.0|0.5|3.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.23|0.50|0.6228
70949260|NCT01210651|141399815|SUPERIORITY_OR_OTHER|||||||0.034||||||Analysis performed via Stata v14.1. Alpha was 2-tailed. P-value was calculated, with p-value \< 0.05 required a priori to reject the null hypothesis.|Regression, Generalized Least Squares|||A random-effects, generalized least squares (GLS) regression model for depression severity was used to analyze participant BDI scores measured just before 1st assigned session at 0 wks, and just after assigned sessions at 2 wks, 4 wks, 6 wks and 8 wks. BDI Scores were modeled as correlated within participants but independent between participants. The GLS regression model tested the null hypothesis that no significant effects on BDI scores would be found by intervention and intervention-by-time.||||0.034
70949261|NCT01210651|141399816|SUPERIORITY_OR_OTHER|||||||0.02||||||Analysis performed via Stata v14.1, with P-value calculated using a t-distribution and assuming unequal variances in the two samples. Alpha was two-tailed. P-value \< 0.05 was required a priori to reject the null hypothesis.|t-test, 2 sided|||Statistical analysis examined Total Change Scores on BDI, using two sample t-test to evaluate the null hypothesis that the Total Change Score on BDI for each intervention group would be statistically comparable.||||0.02
70949262|NCT01210651|141399817|SUPERIORITY_OR_OTHER|||||||0.018||||||Analysis performed via Stata v14.1. Alpha was 2-tailed. P-value was calculated, with a p-value \< 0.05 required a priori to reject the null hypothesis.|Fisher Exact|||Fisher's Exact test evaluated null hypothesis that the proportion of study completers with remitted depression would be statistically comparable in the 2 intervention groups.||||0.018
70949263|NCT01210651|141399818|SUPERIORITY_OR_OTHER|||||||0.5||||||Analysis performed via Stata v14.1, with P-value calculated using a t-distribution and assuming unequal variances in the two samples. Alpha was two-tailed. P-value \< 0.05 was required a priori to reject the null hypothesis.|t-test, 2 sided|||Statistical analysis examined Total Change Scores on GSES, using an independent samples t-test to evaluate null hypothesis that Total Change Score on GSES for each intervention group would be statistically comparable.||||0.50
71141086|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|2.62||||0.046|TWO_SIDED|95.0|1.02|6.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.76|1.02|0.0460
71141087|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|2.07||||0.1215|TWO_SIDED|95.0|0.82|5.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.23|0.82|0.1215
70949264|NCT01210651|141399819|SUPERIORITY_OR_OTHER|||||||0.053||||||Analysis performed via Stata v14.1, with P-value calculated using a t-distribution and assuming unequal variances in the two samples. Alpha was two-tailed. P-value \< 0.05 was required a priori to reject the null hypothesis.|t-test, 2 sided|||Statistical analysis examined Total Change Scores on RSES, using an independent samples t-test to evaluate null hypothesis that Total Change Score on RSES for each intervention group would be statistically comparable.||||0.053
70949265|NCT04855734|141399851|SUPERIORITY||Mean ratio|0.962||||0.835|TWO_SIDED|95.0|0.661|1.396||Threshold for significance was \<0.05.|Mixed Models Analysis|||||1.396|0.661|0.835
70949266|NCT04855734|141399852|SUPERIORITY||Mean ratio|0.826||||0.032|TWO_SIDED|95.0|0.75|0.986||\<0.05 was threshold for significance level.|Mixed Models Analysis|||Meaning/Peace subscale which was a primary outcome.||0.986|0.75|0.032
70949267|NCT04855734|141399858|SUPERIORITY||Mean ratio|1.052||||0.284|TWO_SIDED|95.0|0.959|1.157||\<0.05 threshold for significance level.|Mixed Models Analysis|||Caregiver strain subscale scores at 3 months post-intervention comparing intervention to TAU, controlling for baseline levels.||1.157|0.959|0.284
70949268|NCT04855734|141399858|SUPERIORITY||Mean ratioj|0.931||||0.228|TWO_SIDED|95.0|0.827|1.048||\<0.05 threshold for significance level.|Mixed Models Analysis|||Caregiver distress subscale controlling for baseline levels.||1.048|0.827|0.228
70949269|NCT04855734|141399858|SUPERIORITY||Mean ratio|0.984||||0.504|TWO_SIDED|95.0|0.94|1.032||\<0.05 significance level.|Mixed Models Analysis|||Family well-being subscale controlling for baseline levels.||1.032|0.94|0.504
70949270|NCT04855734|141399858|SUPERIORITY||Mean ratio|0.995||||0.741|TWO_SIDED|95.0|0.967|1.024||\<0.05 significance level.|Mixed Models Analysis|||Positive Caregiving Appraisals subscale at 3 month follow up, controlling for baseline levels.||1.024|0.967|0.741
70949271|NCT04535544|141400108|SUPERIORITY||Difference of percentage|23.7||||0.011|TWO_SIDED|95.0|3.52|43.96|||Mantel-Haenszel|||Stratum-adjusted Mantel-Haenszel (MH) test was used to assess the difference of percentage based on stratification factor: HBeAg status at screening (positive vs negative).||43.96|3.52|0.011
71141088|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|1.75||||0.247|TWO_SIDED|95.0|0.68|4.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.48|0.68|0.2470
71141089|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|1.83||||0.2072|TWO_SIDED|95.0|0.72|4.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.66|0.72|0.2072
71141090|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|2.57||||0.0621|TWO_SIDED|95.0|0.95|6.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.94|0.95|0.0621
71141091|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|5.67||||0.0016|TWO_SIDED|95.0|1.93|16.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||16.69|1.93|0.0016
71141092|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|1.47||||0.4372|TWO_SIDED|95.0|0.56|3.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.84|0.56|0.4372
71141093|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|2.18||||0.11|TWO_SIDED|95.0|0.84|5.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.66|0.84|0.1100
71141094|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|2.55||||0.0533|TWO_SIDED|95.0|0.99|6.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.59|0.99|0.0533
71141095|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|4.68||||0.1769|TWO_SIDED|95.0|0.5|44.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||44.00|0.50|0.1769
71141096|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|2.26||||0.4942|TWO_SIDED|95.0|0.22|23.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||23.53|0.22|0.4942
71141097|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|12.82||||0.0214|TWO_SIDED|95.0|1.46|112.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||112.7|1.46|0.0214
71141098|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|1.93||||0.6013|TWO_SIDED|95.0|0.16|22.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||22.99|0.16|0.6013
71141099|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|8.6||||0.0537|TWO_SIDED|95.0|0.97|76.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||76.58|0.97|0.0537
71141100|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|3.8||||0.2662|TWO_SIDED|95.0|0.36|39.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||39.91|0.36|0.2662
71141101|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|1.51||||0.7431|TWO_SIDED|95.0|0.13|17.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||17.84|0.13|0.7431
71141102|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|3.53||||0.2829|TWO_SIDED|95.0|0.35|35.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||35.22|0.35|0.2829
71141103|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|2.12||||0.5311|TWO_SIDED|95.0|0.2|22.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||22.29|0.20|0.5311
71141104|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|4.71||||0.1857|TWO_SIDED|95.0|0.47|46.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||46.83|0.47|0.1857
70949272|NCT04535544|141400109|SUPERIORITY||Difference of percentage|26.8||||0.003|TWO_SIDED|95.0|7.38|46.21|||Mantel-Haenszel|||Stratum-adjusted MH test was used to assess the difference of percentage based on stratification factor: HBeAg status at screening (positive vs negative).||46.21|7.38|0.003
70949273|NCT05131477|141400114|SUPERIORITY||LS Mean Difference|-32.1|STANDARD_ERROR_OF_MEAN|6.01|<|0.0001|TWO_SIDED|95.0|-43.9|-20.3|||ANCOVA||LS Mean Difference|||-20.3|-43.9|<0.0001
70949274|NCT05131477|141400114|SUPERIORITY||LS Mean Difference|-27.3|STANDARD_ERROR_OF_MEAN|5.98|<|0.0001|TWO_SIDED|95.0|-39.1|-15.6|||ANCOVA||LS Mean Difference|||-15.6|-39.1|<0.0001
70949275|NCT05131477|141400114|SUPERIORITY||LS Mean Difference|-22.2|STANDARD_ERROR_OF_MEAN|6.01||0.0002|TWO_SIDED|95.0|-34.0|-10.4|||ANCOVA||LS Mean Difference|||-10.4|-34.0|0.0002
70949276|NCT05131477|141400114|SUPERIORITY||Mean Difference (Final Values)|-30.2|STANDARD_ERROR_OF_MEAN|5.95|<|0.0001|TWO_SIDED|95.0|-41.9|-18.5|||ANCOVA|||||-18.5|-41.9|<0.0001
70949277|NCT05131477|141400115|SUPERIORITY||LS Mean Difference|-36.8|STANDARD_ERROR_OF_MEAN|6.62|<|0.0001|TWO_SIDED|95.0|-49.8|-23.8|||ANCOVA||LS Mean Difference|||-23.8|-49.8|<0.0001
70949278|NCT05131477|141400115|SUPERIORITY||LS Mean Difference|-24.6|STANDARD_ERROR_OF_MEAN|6.67||0.0002|TWO_SIDED|95.0|-37.7|-11.6|||ANCOVA||LS Mean Difference|||-11.6|-37.7|0.0002
70949279|NCT05131477|141400115|SUPERIORITY||LS Mean Difference|-26.2|STANDARD_ERROR_OF_MEAN|6.65|<|0.0001|TWO_SIDED|95.0|-39.2|-13.1|||ANCOVA||LS Mean Difference|||-13.1|-39.2|<0.0001
71141105|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9879|TWO_SIDED|95.0|0.06|17.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||17.50|0.06|0.9879
71141106|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|4.57||||0.1853|TWO_SIDED|95.0|0.48|43.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||43.19|0.48|0.1853
71141107|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|4.43||||0.217|TWO_SIDED|95.0|0.42|46.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||46.93|0.42|0.2170
71141108|NCT03192176|141778531|SUPERIORITY||Odds Ratio (OR)|0.74||||0.8354|TWO_SIDED|95.0|0.04|12.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||12.62|0.04|0.8354
71141109|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|0.94||||0.9671|TWO_SIDED|95.0|0.06|16.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.04|0.06|0.9671
71141110|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|3.16||||0.3289|TWO_SIDED|95.0|0.31|31.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||31.87|0.31|0.3289
70949280|NCT05131477|141400115|SUPERIORITY||LS Mean Difference|-26.8|STANDARD_ERROR_OF_MEAN|6.58|<|0.0001|TWO_SIDED|95.0|-39.7|-13.9|||ANCOVA||LS Mean Difference|||-13.9|-39.7|<0.0001
71141111|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|3.26||||0.3157|TWO_SIDED|95.0|0.32|32.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||32.71|0.32|0.3157
71141112|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|1.0||||0.991|TWO_SIDED|95.0|0.06|16.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.83|0.06|0.991
70949281|NCT05131477|141400116|SUPERIORITY||Proportion Difference|0.29|||<|0.0001|TWO_SIDED|95.0|0.16|0.42|||Cochran-Mantel-Haenszel|||Week 16||0.42|0.16|< 0.0001
70949282|NCT05131477|141400116|SUPERIORITY||Proportion Difference|0.27|||<|0.0001|TWO_SIDED|95.0|0.14|0.4|||Cochran-Mantel-Haenszel|||Week 16||0.40|0.14|< 0.0001
70949283|NCT05131477|141400116|SUPERIORITY||Proportion Difference|0.31|||<|0.0001|TWO_SIDED|95.0|0.18|0.44|||Cochran-Mantel-Haenszel|||Week 16||0.44|0.18|<0.0001
70949284|NCT05131477|141400116|SUPERIORITY||Proportion Difference|0.29|||<|0.0001|TWO_SIDED|95.0|0.16|0.42|||Cochran-Mantel-Haenszel|||Week 16||0.42|0.16|<0.0001
70949285|NCT05131477|141400116|SUPERIORITY||Proportion Difference|0.36|||<|0.0001|TWO_SIDED|95.0|0.23|0.5|||Cochran-Mantel-Haenszel|||Week 24||0.5|0.23|<0.0001
70949286|NCT05131477|141400116|SUPERIORITY||Proportion Difference|0.21||||0.004|TWO_SIDED|95.0|0.07|0.34|||Cochran-Mantel-Haenszel|||Week 24||0.34|0.07|0.0040
70949287|NCT05131477|141400116|SUPERIORITY||Proportion Difference|0.31|||<|0.0001|TWO_SIDED|95.0|0.17|0.45|||Cochran-Mantel-Haenszel|||||0.45|0.17|<0.0001
70949288|NCT05131477|141400116|SUPERIORITY||Proportion Difference|0.23||||0.0016|TWO_SIDED|95.0|0.09|0.36|||Cochran-Mantel-Haenszel|||||0.36|0.09|0.0016
70949289|NCT05131477|141400117|SUPERIORITY||Proportion Difference|0.17||||0.0022|TWO_SIDED|95.0|0.06|0.27|||Cochran-Mantel-Haenszel|||Week 16||0.27|0.06|0.0022
71141113|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|2.26||||0.5139|TWO_SIDED|95.0|0.2|26.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||26.12|0.20|0.5139
70949290|NCT05131477|141400117|SUPERIORITY||Proportion Difference|0.09||||0.0562|TWO_SIDED|95.0|0.0|0.18|||Cochran-Mantel-Haenszel|||Week 16||0.18|0|0.0562
70949291|NCT05131477|141400117|SUPERIORITY||Proportion Difference|0.14||||0.0054|TWO_SIDED|95.0|0.04|0.24|||Cochran-Mantel-Haenszel|||Week 16||0.24|0.04|0.0054
70949292|NCT05131477|141400117|SUPERIORITY||Proportion Difference|0.2||||0.0003|TWO_SIDED|95.0|0.1|0.31|||Cochran-Mantel-Haenszel|||Week 16||0.31|0.1|0.0003
70949293|NCT05131477|141400117|SUPERIORITY||Proportion Difference|0.34|||<|0.0001|TWO_SIDED|95.0|0.21|0.47|||Cochran-Mantel-Haenszel|||Week 24||0.47|0.21|<0.0001
70949294|NCT05131477|141400117|SUPERIORITY||Proportion Difference|0.22||||0.0008|TWO_SIDED|95.0|0.1|0.34|||Cochran-Mantel-Haenszel|||Week 24||0.34|0.1|0.0008
70949295|NCT05131477|141400117|SUPERIORITY||Proportion Difference|0.29|||<|0.0001|TWO_SIDED|95.0|0.16|0.41|||Cochran-Mantel-Haenszel|||Week 24||0.41|0.16|<0.0001
70949296|NCT05131477|141400117|SUPERIORITY||Proportion Difference|0.18||||0.0046|TWO_SIDED|95.0|0.06|0.3|||Cochran-Mantel-Haenszel|||Week 24||0.3|0.06|0.0046
70949297|NCT05131477|141400118|SUPERIORITY||Proportion Difference|0.19||||0.0006|TWO_SIDED|95.0|0.09|0.3|||Cochran-Mantel-Haenszel|||Week 16||0.3|0.09|0.0006
70949298|NCT05131477|141400118|SUPERIORITY||Proportion Difference|0.14||||0.0057|TWO_SIDED|95.0|0.04|0.24|||Cochran-Mantel-Haenszel|||Week 16||0.24|0.04|0.0057
70949299|NCT05131477|141400118|SUPERIORITY||Proportion Difference|0.16||||0.0038|TWO_SIDED|95.0|0.05|0.26|||Cochran-Mantel-Haenszel|||Week 16||0.26|0.05|0.0038
70949300|NCT05131477|141400118|SUPERIORITY||Proportion Difference|0.18||||0.0011|TWO_SIDED|95.0|0.07|0.28|||Cochran-Mantel-Haenszel|||Week 16||0.28|0.07|0.0011
70866701|NCT02468674|141219864|OTHER|||||||0.885|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49||||0.885
70949301|NCT05131477|141400118|SUPERIORITY||Proportion Difference|0.23||||0.0002|TWO_SIDED|95.0|0.11|0.35|||Cochran-Mantel-Haenszel|||Week 24||0.35|0.11|0.0002
70949302|NCT05131477|141400118|SUPERIORITY||Proportion Difference|0.17||||0.0038|TWO_SIDED|95.0|0.06|0.28|||Cochran-Mantel-Haenszel|||Week 24||0.28|0.06|0.0038
70866702|NCT02468674|141219864|OTHER|||||||0.84|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49||||0.840
70949303|NCT05131477|141400118|SUPERIORITY||Proportion Difference|0.21||||0.0006|TWO_SIDED|95.0|0.09|0.32|||Cochran-Mantel-Haenszel|||Week 24||0.32|0.09|0.0006
70949304|NCT05131477|141400118|SUPERIORITY||Proportion Difference|20.0||||0.0008|TWO_SIDED|95.0|9.0|32.0|||Cochran-Mantel-Haenszel|||Week 24||32|9|0.0008
70949305|NCT01124838|141400175|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57||||0.004|TWO_SIDED|95.0|0.39|0.84|||Log Rank|||The primary analysis of the primary endpoint was performed on Main Study data, excluding the Japanese sub-study. The statistical test was performed at a 2-sided significance level of 0.05. The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment as factor.||0.84|0.39|0.004
70949306|NCT01124838|141400175|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.37|0.74|||Log Rank|||An additional analysis of the primary endpoint was performed using the Integrated Study data (Main Study + Japan sub-study). The statistical test was performed at a 2-sided significance level of 0.05. The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment and race (Japanese versus non-Japanese) as factors.||0.74|0.37|<0.001
70949307|NCT01124838|141400176|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.14||||0.218|TWO_SIDED|95.0|-0.37|0.08|||ANOVA|From ANOVA with treatment as factor adjusted for clustered observations (i.e., observations from each of the participant's eyes).|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||0.08|-0.37|0.218
70949308|NCT01124838|141400176|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.15||||0.164|TWO_SIDED|95.0|-0.36|0.06|||ANOVA|From ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||0.06|-0.36|0.164
70949309|NCT01124838|141400177|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.13||||0.07|TWO_SIDED|95.0|-0.28|0.01|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as factor|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||0.01|-0.28|0.070
70949310|NCT01124838|141400177|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.17||||0.016|TWO_SIDED|95.0|-0.31|-0.03|||ANOVA|From ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.03|-0.31|0.016
70949311|NCT01124838|141400178|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.04||||0.096|TWO_SIDED|95.0|-0.08|0.01|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as factor adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||0.01|-0.08|0.096
70949312|NCT01124838|141400178|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.04||||0.044|TWO_SIDED|95.0|-0.09|0.0|||ANOVA|From ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||0.00|-0.09|0.044
70866703|NCT02468674|141219865|OTHER|||||||0.367|||||||ANCOVA|Difference in the least square means (SE)||Population II: 6MWT at Week 49||||0.367
70866704|NCT02468674|141219866|OTHER|||||||0.875|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49||||0.875
70866705|NCT02468674|141219866|OTHER|||||||0.909|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49||||0.909
70866706|NCT02468674|141219866|OTHER|||||||0.168|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49||||0.168
70866707|NCT02468674|141219866|OTHER|||||||0.632|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49||||0.632
70866708|NCT02468674|141219866|OTHER|||||||0.31|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49||||0.310
70866709|NCT02468674|141219866|OTHER|||||||0.321|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49||||0.321
70866710|NCT02468674|141219867|OTHER|||||||0.395|||||||ANCOVA|Difference in the least square means (SE)||Population II: Gait speed at Week 49||||0.395
70866711|NCT02468674|141219868|OTHER|||||||0.12|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49||||0.120
70866712|NCT02468674|141219868|OTHER|||||||0.297|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49||||0.297
70866713|NCT02468674|141219868|OTHER|||||||0.074|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49||||0.074
70866714|NCT02468674|141219868|OTHER|||||||0.022|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49||||0.022
70866715|NCT02468674|141219868|OTHER|||||||0.106|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49||||0.106
70866716|NCT02468674|141219868|OTHER|||||||0.211|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49||||0.211
70866717|NCT02468674|141219869|OTHER|||||||1|||||||ANCOVA|Difference in the least square geometric means||Population II: ASMI at Week 49||||1.000
70866718|NCT02468674|141219870|OTHER|||||||0.084|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49||||0.084
70866719|NCT02468674|141219870|OTHER|||||||0.283|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49||||0.283
70866720|NCT02468674|141219870|OTHER|||||||0.323|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49||||0.323
70866721|NCT02468674|141219870|OTHER|||||||0.018|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49||||0.018
70866722|NCT02468674|141219870|OTHER|||||||0.179|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49||||0.179
70866723|NCT02468674|141219870|OTHER|||||||0.227|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49||||0.227
70866724|NCT02468674|141219871|OTHER|||||||1|||||||ANCOVA|Difference in the least square geometric means||Population II: LBM at Week 49||||1.000
70866725|NCT03689530|141219891|SUPERIORITY|||||||0.7436|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.7436
70866726|NCT03689530|141219892|SUPERIORITY|||||||0.1212|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.1212
70866727|NCT03689530|141219893|SUPERIORITY|||||||0.8839|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.8839
70866728|NCT03689530|141219894|SUPERIORITY|||||||0.1137|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.1137
70866729|NCT03689530|141219895|SUPERIORITY|||||||0.0162|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.0162
70866730|NCT03689530|141219897|SUPERIORITY|||||||0.2117|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.2117
70866731|NCT03689530|141219898|SUPERIORITY|||||||0.4169|||||||Mixed Models Analysis|||||||0.4169
70866732|NCT03689530|141219899|SUPERIORITY|||||||0.8785|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.8785
70866733|NCT03689530|141219900|SUPERIORITY|||||||0.1006|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.1006
70866734|NCT03689530|141219901|SUPERIORITY|||||||0.7168|||||||Mixed Models Analysis|||||||0.7168
70866735|NCT03689530|141219902|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.0001
70866736|NCT03689530|141219903|OTHER|Single group analysis for peer support group only|Mean|3.799|STANDARD_DEVIATION|0.885|||TWO_SIDED|||||||||||||
70866737|NCT03689530|141219904|OTHER|Single group analysis for peer support group only|Mean|3.732|STANDARD_DEVIATION|0.985|||TWO_SIDED|||||||||||||
70866738|NCT03689530|141219905|OTHER|Single group analysis for peer support group only|Mean|6.222|STANDARD_DEVIATION|1.083|||TWO_SIDED|||||||||||||
70866739|NCT03689530|141219906|OTHER|Single group analysis for peer support group only|Mean|6.179|STANDARD_DEVIATION|1.141|||TWO_SIDED|||||||||||||
70866740|NCT03689530|141219907|SUPERIORITY|||||||0.9126|||||||Mixed Models Analysis|||||||0.9126
70866741|NCT03689530|141219908|SUPERIORITY|||||||0.7405|||||||Mixed Models Analysis|||||||0.7405
70866742|NCT03689530|141219909|SUPERIORITY|||||||0.5956|||||||Mixed Models Analysis|||||||0.5956
70866743|NCT03689530|141219910|SUPERIORITY|||||||0.3341|||||||Mixed Models Analysis|||||||0.3341
70866744|NCT03689530|141219911|SUPERIORITY|||||||0.2049|||||||Mixed Models Analysis|||||||0.2049
70866745|NCT03689530|141219912|SUPERIORITY|||||||0.0335|||||||Mixed Models Analysis|||||||0.0335
70866746|NCT03689530|141219913|SUPERIORITY|||||||0.3219|||||||Mixed Models Analysis|||||||0.3219
70866747|NCT03689530|141219914|SUPERIORITY|||||||0.5223|||||||Mixed Models Analysis|||||||0.5223
70866748|NCT01392443|141219915|OTHER|||||||0.0007|||||||single-sample biniminal test|||||||0.0007
70866749|NCT03019575|141219924|OTHER|Linear Mixed Model|Geometric Mean Ratio|9.43|||||TWO_SIDED|95.0|7.44|11.97||||||||11.97|7.44|
70866750|NCT00533897|141219941|SUPERIORITY_OR_OTHER||estimate of difference|9.59||||0.119|TWO_SIDED|95.0|0.83|18.34||There was no adjustment made for multiple comparisons.|Chi-squared, Corrected|||A continuity corrected Chi-square test was used to compare percentage of positive antibody responses of SC placebo vs. SC abatacept (Period II treatment groups) on Day 169. P-value was evaluated at 0.05 significance level (2-sided). 95% confidence interval (CI) for difference (SC PLA - SC ABA) between ABA and PLA in the immunogenicity rates was also calculated. Point estimates of the immunogenicity rates within the two Period II treatment group and the corresponding 95% CIs were also provided.||18.34|0.83|0.119
70866751|NCT00533897|141219942|SUPERIORITY_OR_OTHER||Estimate of Difference|4.88|||||TWO_SIDED|95.0|-4.5|14.25||||||Immunogenicity rates of the Period II treatment groups on Day 253 were analyzed similarly as on Day 169. However, no statistical test was carried out and no p-value was provided. Provided were: point estimates of the immunogenicity rates within the Period II treatment groups and corresponding 95% CIs, and point estimate for the difference in immunogenicity rates between these groups and corresponding 95% CI. There was no adjustment made for multiple comparisons.||14.25|-4.50|
70866752|NCT00533897|141219946|SUPERIORITY_OR_OTHER||Estimate of Difference|0.11|||||TWO_SIDED|95.0|-8.21|8.43||||||Immunogenicity rates of the Period II treatment groups on Day 253 were analyzed similarly as on Day 169. However, no statistical test was carried out and no p-value was provided. Provided were: point estimates of the immunogenicity rates within the Period II treatment groups and corresponding 95% CIs, and point estimate for the difference in immunogenicity rates between these groups and corresponding 95% CI. There was no adjustment made for multiple comparisons.||8.43|-8.21|
70866753|NCT02555683|141220008|SUPERIORITY||rate ratio|1.04||||0.8|TWO_SIDED|95.0|0.77|1.41||adjusted p-value|negative binomial regression model|Adjusted p-values obtained from the closed testing procedure||||1.41|0.77|0.800
70866754|NCT02555683|141220008|SUPERIORITY||Rate Ratio|0.83||||0.51|TWO_SIDED|95.0|0.61|1.14||adjusted p-value|negative binomial regression model|Adjusted p-values are based on the closed testing procedure||||1.14|0.61|0.510
70866755|NCT02555683|141220009|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.095||0.819|TWO_SIDED|95.0|-0.11|0.26||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.26|-0.11|0.819
70866756|NCT02555683|141220009|SUPERIORITY||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.095||0.591|TWO_SIDED|95.0|-0.05|0.32||adjusted p-vale|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.32|-0.05|0.591
70866757|NCT02555683|141220010|SUPERIORITY||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.098||0.819|TWO_SIDED|95.0|-0.31|0.07||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.07|-0.31|0.819
70866758|NCT02555683|141220010|SUPERIORITY||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.098||0.591|TWO_SIDED|95.0|-0.37|0.02||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.02|-0.37|0.591
70866759|NCT02555683|141220011|SUPERIORITY||Mean Difference (Net)|0.067|STANDARD_ERROR_OF_MEAN|0.0365||0.8|TWO_SIDED|95.0|-0.005|0.139||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.139|-0.005|0.800
70866760|NCT02555683|141220011|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.0363||0.523|TWO_SIDED|95.0|-0.021|0.121||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.121|-0.021|0.523
70866761|NCT02555683|141220012|SUPERIORITY||rate ratio|0.96||||0.819|TWO_SIDED|95.0|0.75|1.22||adjusted p-value|negative binomial regression model|Adjusted p-values obtained from the closed testing procedure||||1.22|0.75|0.819
70866762|NCT02555683|141220012|SUPERIORITY||Rate Ratio|0.78||||0.51|TWO_SIDED|95.0|0.61|1.01||adjusted p-value|negative binomial regression model|Adjusted p-values are based on the closed testing procedure||||1.01|0.61|0.510
70866763|NCT02555683|141220013|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.076||0.819|TWO_SIDED|95.0|-0.07|0.23||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.23|-0.07|0.819
70866764|NCT02555683|141220013|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.076||0.591|TWO_SIDED|95.0|-0.03|0.27||adjusted p-vale|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.27|-0.03|0.591
71141114|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|3.32||||0.3079|TWO_SIDED|95.0|0.33|33.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||33.45|0.33|0.3079
70866765|NCT02555683|141220014|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.079||0.819|TWO_SIDED|95.0|-0.27|0.04||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.04|-0.27|0.819
70866766|NCT02555683|141220014|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.079||0.591|TWO_SIDED|95.0|-0.35|-0.04||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||-0.04|-0.35|0.591
70866767|NCT02555683|141220015|SUPERIORITY||Mean Difference (Net)|0.076|STANDARD_ERROR_OF_MEAN|0.0292||0.819|TWO_SIDED|95.0|0.019|0.134||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.134|0.019|0.819
70866768|NCT02555683|141220015|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.0292||0.591|TWO_SIDED|95.0|-0.017|0.097||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.097|-0.017|0.591
70866769|NCT03019185|141220040|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 12.|LS Mean change from baseline|13.37|STANDARD_ERROR_OF_MEAN|1.4111|<|0.0001|TWO_SIDED|95.0|10.48|16.27|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 12 were included. Missing data were not imputed.||||16.27|10.48|<0.0001
70866770|NCT03019185|141220041|SUPERIORITY||LS Mean difference (Net)|9.49|STANDARD_ERROR_OF_MEAN|1.813|<|0.0001|TWO_SIDED|97.5|5.38|13.6|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 48 were included. Missing data were not imputed.|Difference is bardoxolone methyl - placebo|||13.60|5.38|<0.0001
70866771|NCT03019185|141220042|SUPERIORITY||LS Mean difference (Net)|7.65|STANDARD_ERROR_OF_MEAN|2.144||0.0005|TWO_SIDED|95.0|3.41|11.89|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 100 (excluding Week 52) were included. Missing data were not imputed.|Difference is bardoxolone methyl - placebo|||11.89|3.41|0.0005
70949313|NCT01124838|141400179|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.491|TWO_SIDED|95.0|0.34|1.69|||Log Rank||The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment as factor.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||1.69|0.34|0.491
71141115|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|8.83||||0.0469|TWO_SIDED|95.0|1.03|75.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||75.68|1.03|0.0469
71141116|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|14.39||||0.0134|TWO_SIDED|95.0|1.74|119.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||119.1|1.74|0.0134
71141117|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|4.98||||0.1606|TWO_SIDED|95.0|0.53|46.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||46.90|0.53|0.1606
71141118|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|6.69||||0.0854|TWO_SIDED|95.0|0.77|58.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||58.35|0.77|0.0854
71141119|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|6.07||||0.1082|TWO_SIDED|95.0|0.67|54.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||54.72|0.67|0.1082
71141120|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|7.22||||0.0737|TWO_SIDED|95.0|0.83|63.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||63.04|0.83|0.0737
71141121|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|11.98||||0.0217|TWO_SIDED|95.0|1.44|99.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||99.74|1.44|0.0217
71141122|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|19.24||||0.0058|TWO_SIDED|95.0|2.36|157.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||157.1|2.36|0.0058
71141123|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|4.44||||0.1924|TWO_SIDED|95.0|0.47|41.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||41.87|0.47|0.1924
71141124|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|7.54||||0.068|TWO_SIDED|95.0|0.86|66.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||66.00|0.86|0.0680
71141125|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|15.95||||0.0095|TWO_SIDED|95.0|1.97|129.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||129.4|1.97|0.0095
71141126|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|3.68||||0.269|TWO_SIDED|95.0|0.36|37.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||37.21|0.36|0.2690
71141127|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|10.28||||0.0321|TWO_SIDED|95.0|1.22|86.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||86.53|1.22|0.0321
71141128|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|14.48||||0.0131|TWO_SIDED|95.0|1.75|119.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||119.7|1.75|0.0131
71141129|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|25.22||||0.0025|TWO_SIDED|95.0|3.11|204.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||204.6|3.11|0.0025
71141130|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|4.65||||0.1788|TWO_SIDED|95.0|0.49|43.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||43.72|0.49|0.1788
71141131|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|10.33||||0.032|TWO_SIDED|95.0|1.22|87.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||87.31|1.22|0.0320
71141132|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|11.24||||0.0251|TWO_SIDED|95.0|1.35|93.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||93.33|1.35|0.0251
71141133|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|1.43||||0.6154|TWO_SIDED|95.0|0.35|5.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.83|0.35|0.6154
71141134|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|2.37||||0.1906|TWO_SIDED|95.0|0.65|8.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.63|0.65|0.1906
71141135|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|3.67||||0.045|TWO_SIDED|95.0|1.03|13.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||13.07|1.03|0.0450
71141136|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|7.19||||0.0017|TWO_SIDED|95.0|2.1|24.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||24.66|2.10|0.0017
71141137|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|1.8||||0.3939|TWO_SIDED|95.0|0.47|6.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.97|0.47|0.3939
70866772|NCT03019185|141220043|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 48.|LS Mean change from baseline|7.4|STANDARD_ERROR_OF_MEAN|1.9451||0.0008|TWO_SIDED|95.0|3.4|11.39|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 48 were included. Missing data were not imputed.||||11.39|3.40|0.0008
70866773|NCT03019185|141220044|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 100.|LS Mean change from baseline|4.28|STANDARD_ERROR_OF_MEAN|1.7484||0.015|TWO_SIDED|95.0|0.84|7.72|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 100 (excluding Week 52) were included. Missing data were not imputed.||||7.72|0.84|0.0150
70866774|NCT03019185|141220045|SUPERIORITY||LS Mean difference (Net)|5.09|STANDARD_ERROR_OF_MEAN|1.656||0.0021|TWO_SIDED|97.5|1.37|8.8|||ANCOVA|Missing eGFR data were imputed using multiple imputation based on the treatment group to which the patient was assigned.|Difference is bardoxolone methyl - placebo|||8.80|1.37|0.0021
70949314|NCT01124838|141400179|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6||||0.185|TWO_SIDED|95.0|0.28|1.28|||Log Rank||The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment and race (Japanese versus non-Japanese) as factors.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||1.28|0.28|0.185
70949315|NCT01124838|141400180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-2.3||||0.451|TWO_SIDED|95.0|-8.5|3.8|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment and OCT machine as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||3.8|-8.5|0.451
70949316|NCT01124838|141400180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-3.9||||0.174|TWO_SIDED|95.0|-9.7|1.8|||ANOVA|From ANOVA with treatment, race (Japanese versus non-Japanese) and OCT machine as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||1.8|-9.7|0.174
70949317|NCT01124838|141400181|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|2.12||||0.16|TWO_SIDED|95.0|-0.84|5.08|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||5.08|-0.84|0.160
71141138|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|2.06||||0.2869|TWO_SIDED|95.0|0.55|7.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.74|0.55|0.2869
71141139|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|2.41||||0.1817|TWO_SIDED|95.0|0.66|8.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.80|0.66|0.1817
71141140|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|11.41||||0.0256|TWO_SIDED|95.0|1.35|96.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||96.77|1.35|0.0256
71141141|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|13.65||||0.0153|TWO_SIDED|95.0|1.65|112.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||112.8|1.65|0.0153
70866775|NCT03019185|141220046|SUPERIORITY||LS Mean difference (Net)|4.26|STANDARD_ERROR_OF_MEAN|1.876||0.0232|TWO_SIDED|95.0|0.58|7.94|||ANCOVA|Missing eGFR data were imputed using multiple imputation based on the treatment group to which the patient was assigned.|Difference is bardoxolone methyl - placebo|||7.94|0.58|0.0232
70866776|NCT00705289|141220068|SUPERIORITY_OR_OTHER||Pearson Product Moment Correlation|0.1402||||0.0003|||||||Test for non-zero correlation|||Relationship between baseline DAS28 and age (prior to infliximab therapy)||||0.0003
70949318|NCT01124838|141400181|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|1.77||||0.205|TWO_SIDED|95.0|-0.97|4.52|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||4.52|-0.97|0.205
70949319|NCT01124838|141400182|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|1.88||||0.401|TWO_SIDED|95.0|-2.53|6.29|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||6.29|-2.53|0.401
70949320|NCT01124838|141400182|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|2.36||||0.256|TWO_SIDED|95.0|-1.73|6.45|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||6.45|-1.73|0.256
70949321|NCT01124838|141400183|SUPERIORITY_OR_OTHER_LEGACY||Mena Difference|-0.1||||0.967|TWO_SIDED|95.0|-4.81|4.61|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||4.61|-4.81|0.967
70949322|NCT01124838|141400183|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.87||||0.714|TWO_SIDED|95.0|-5.53|3.79|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||3.79|-5.53|0.714
70949323|NCT01124838|141400184|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|0.56||||0.83|TWO_SIDED|95.0|-4.56|5.68|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||5.68|-4.56|0.830
70949324|NCT01124838|141400184|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.49||||0.842|TWO_SIDED|95.0|-5.32|4.34|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment and race (Japanese vs. non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||4.34|-5.32|0.842
70949325|NCT04297618|141400185|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71141142|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|21.76||||0.0042|TWO_SIDED|95.0|2.64|179.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||179.2|2.64|0.0042
70949326|NCT04297618|141400186|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
70949327|NCT02726945|141400212|SUPERIORITY|||||||0.023|||||||Wilcoxon (Mann-Whitney)|||"Data from the groups showed a strong non-normal distribution, thus non-parametric methods were used with a Bonferroni correction for multiple comparison .~Statistical significance was defined as either of the treatment groups to be superior to the placebo group."||||0.023
70949328|NCT02726945|141400212|SUPERIORITY|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||"Data from the groups showed a strong non-normal distribution, thus non-parametric methods were used with a Bonferroni correction for multiple comparison .~Statistical significance was defined as either of the treatment groups to be superior to the placebo group."||||0.043
70949329|NCT03728985|141400213|NON_INFERIORITY|Performance Goal 80%|Absolute Percentage with Success|77.5||||0.5908|TWO_SIDED|90.0|69.6|84.1|||Fisher Exact||The lower estimated confidence interval above the Performance Goal of 80% would be considered success.|||84.1|69.6|0.5908
70949330|NCT03728985|141400214|NON_INFERIORITY|Performance Goal 68%|Percentage with Success|70.6||||0.7017|TWO_SIDED|90.0|61.4|78.7|||Fisher Exact|||||78.7|61.4|0.7017
70949331|NCT01606319|141400282|SUPERIORITY_OR_OTHER||relative rate|0.94||||0.67|TWO_SIDED|95.0|0.69|1.28|||log-linear model|log-linear model in which the number of exacerbations was assumed to follow a negative binomial distribution|relative rate with acetaminophen in the numerator and ibuprofen in the denominator|||1.28|.69|0.67
71141143|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|35.75||||0.0008|TWO_SIDED|95.0|4.39|291.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||291.5|4.39|0.0008
70949332|NCT01606319|141400283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.5|TWO_SIDED|95.0|-0.039|0.0019|||ANCOVA|||||.0019|-0.039|0.5
70949333|NCT01606319|141400284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.69|TWO_SIDED|95.0|-0.9|0.6|||ANCOVA|||||0.6|-0.9|0.69
70949334|NCT01606319|141400285|SUPERIORITY_OR_OTHER||relative rate|0.99||||0.94|TWO_SIDED|95.0|0.72|1.37|||log-linear model|log-linear model in which the number of exacerbations was assumed to follow a negative binomial distribution|relative rate with acetaminophen in the numerator and ibuprofen in the denominator|||1.37|0.72|.94
70949335|NCT01124097|141400290|SUPERIORITY_OR_OTHER|||||||0.9321|||||||Dunnett's test|||||||0.9321
70949336|NCT01124097|141400290|SUPERIORITY_OR_OTHER|||||||0.261|||||||Dunnett's test|||||||0.2610
70949337|NCT01124097|141400290|SUPERIORITY_OR_OTHER|||||||0.4764|||||||Dunnett's test|||||||0.4764
70949338|NCT01304498|141400304|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.67|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.85|1.11|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 16||1.11|0.85|<0.001
70949339|NCT01304498|141400304|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.67|GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.91|1.29|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 18||1.29|0.91|<0.001
71141144|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|6.45||||0.0967|TWO_SIDED|95.0|0.71|58.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||58.21|0.71|0.0967
71141145|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|8.3||||0.0564|TWO_SIDED|95.0|0.94|72.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||72.95|0.94|0.0564
70866777|NCT00705289|141220069|SUPERIORITY_OR_OTHER||Pearson Product Moment Correlation|-0.01||||0.7991||95.0|||||Test for non-zero correlation|||Relationship between baseline DAS28 and time since diagnosis (prior to infliximab therapy)||||0.7991
70866778|NCT00705289|141220070|SUPERIORITY_OR_OTHER|||||||0.7152||95.0|||||ANOVA|The association between Baseline DAS28 and gender is based on a one-way Anova.||Relationship between baseline DAS28 and gender (prior to infliximab therapy)||||0.7152
70866779|NCT00705289|141220071|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|Relationship between DAS28 and Country of Residence was based on a 1-way ANOVA calculated as P-value.||Relationship between baseline DAS28 and country of residence (prior to infliximab therapy)||||<0.0001
71141146|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|23.63||||0.003|TWO_SIDED|95.0|2.93|190.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||190.5|2.93|0.0030
71141147|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|9.72||||0.0384|TWO_SIDED|95.0|1.13|83.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||83.68|1.13|0.0384
71141148|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|13.65||||0.0153|TWO_SIDED|95.0|1.65|112.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||112.9|1.65|0.0153
71141149|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|30.55||||0.0015|TWO_SIDED|95.0|3.72|250.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||250.6|3.72|0.0015
71141150|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|35.99||||0.0008|TWO_SIDED|95.0|4.41|293.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||293.5|4.41|0.0008
71141151|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|12.67||||0.0192|TWO_SIDED|95.0|1.51|106.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||106.1|1.51|0.0192
71141152|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|16.92||||0.0089|TWO_SIDED|95.0|2.03|141.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||141.0|2.03|0.0089
71141153|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|24.96||||0.0025|TWO_SIDED|95.0|3.09|201.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||201.6|3.09|0.0025
71141154|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|3.03||||0.091|TWO_SIDED|95.0|0.84|10.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||10.94|0.84|0.0910
71141155|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|3.96||||0.0296|TWO_SIDED|95.0|1.15|13.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||13.67|1.15|0.0296
71141156|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|8.23||||0.0009|TWO_SIDED|95.0|2.38|28.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||28.44|2.38|0.0009
71141157|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|8.54||||0.0007|TWO_SIDED|95.0|2.46|29.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||29.63|2.46|0.0007
71141158|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|1.76||||0.4152|TWO_SIDED|95.0|0.45|6.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.86|0.45|0.4152
71141159|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|3.29||||0.07|TWO_SIDED|95.0|0.91|11.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||11.93|0.91|0.0700
70866780|NCT00705289|141220072|SUPERIORITY_OR_OTHER||Mean Baseline DAS28 Raw Score|5.2|STANDARD_DEVIATION|1.15||||95.0|5.1|5.3||||||Relationship between Baseline DAS28 and previous anti-TNF therapy (all subjects, prior to infliximab therapy)||5.3|5.1|
71141160|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|5.83||||0.0048|TWO_SIDED|95.0|1.71|19.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||19.84|1.71|0.0048
71141161|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|2.44||||0.1497|TWO_SIDED|95.0|0.72|8.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.23|0.72|0.1497
71141162|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|3.05||||0.0608|TWO_SIDED|95.0|0.95|9.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||9.77|0.95|0.0608
71141163|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|5.99||||0.0028|TWO_SIDED|95.0|1.85|19.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||19.34|1.85|0.0028
71141164|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|7.84||||0.0005|TWO_SIDED|95.0|2.45|25.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||25.13|2.45|0.0005
71141165|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|1.15||||0.8393|TWO_SIDED|95.0|0.3|4.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.39|0.30|0.8393
71141166|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|4.01||||0.0215|TWO_SIDED|95.0|1.23|13.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.10|1.23|0.0215
71141167|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|4.42||||0.0112|TWO_SIDED|95.0|1.4|13.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.94|1.40|0.0112
71141168|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|1.71||||0.3498|TWO_SIDED|95.0|0.55|5.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.29|0.55|0.3498
71141169|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|2.05||||0.1981|TWO_SIDED|95.0|0.69|6.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.08|0.69|0.1981
71141170|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0029|TWO_SIDED|95.0|1.76|15.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||15.78|1.76|0.0029
71141171|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|5.95||||0.0011|TWO_SIDED|95.0|2.03|17.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||17.40|2.03|0.0011
71141172|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|0.96||||0.9511|TWO_SIDED|95.0|0.29|3.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.23|0.29|0.9511
71141173|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|1.76||||0.3241|TWO_SIDED|95.0|0.57|5.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.45|0.57|0.3241
71141174|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|3.9||||0.0111|TWO_SIDED|95.0|1.36|11.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||11.16|1.36|0.0111
71141175|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|2.51||||0.1375|TWO_SIDED|95.0|0.74|8.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.48|0.74|0.1375
71141176|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|3.02||||0.067|TWO_SIDED|95.0|0.93|9.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.83|0.93|0.0670
71141177|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|7.57||||0.0009|TWO_SIDED|95.0|2.29|25.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||25.04|2.29|0.0009
71141178|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|9.42||||0.0002|TWO_SIDED|95.0|2.91|30.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||30.49|2.91|0.0002
71141179|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|2.75||||0.0982|TWO_SIDED|95.0|0.83|9.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.14|0.83|0.0982
71141180|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|2.6||||0.1233|TWO_SIDED|95.0|0.77|8.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.80|0.77|0.1233
71141181|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|4.63||||0.0091|TWO_SIDED|95.0|1.46|14.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||14.64|1.46|0.0091
71141182|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|1.03||||0.962|TWO_SIDED|95.0|0.34|3.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.10|0.34|0.9620
71141183|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|1.63||||0.3527|TWO_SIDED|95.0|0.58|4.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.59|0.58|0.3527
71141184|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|3.04||||0.0394|TWO_SIDED|95.0|1.06|8.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.76|1.06|0.0394
71141185|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|3.36||||0.0224|TWO_SIDED|95.0|1.19|9.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||9.53|1.19|0.0224
71141186|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|1.16||||0.7891|TWO_SIDED|95.0|0.39|3.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.44|0.39|0.7891
71141187|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|2.48||||0.0851|TWO_SIDED|95.0|0.88|6.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.99|0.88|0.0851
71141188|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|1.74||||0.2885|TWO_SIDED|95.0|0.63|4.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.83|0.63|0.2885
71141189|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|0.78||||0.8611|TWO_SIDED|95.0|0.05|13.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||13.30|0.05|0.8611
71141190|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|1.48||||0.7549|TWO_SIDED|95.0|0.13|17.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||17.42|0.13|0.7549
71141191|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|2.07||||0.5658|TWO_SIDED|95.0|0.17|24.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||24.66|0.17|0.5658
71141192|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|1.83||||0.6319|TWO_SIDED|95.0|0.15|21.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||21.86|0.15|0.6319
71141193|NCT03192176|141778532|SUPERIORITY||Odds Ratio (OR)|1.09||||0.9526|TWO_SIDED|95.0|0.06|18.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||18.96|0.06|0.9526
71141194|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|1.74||||0.2251|TWO_SIDED|95.0|0.71|4.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||4.26|0.71|0.2251
71141195|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|3.57||||0.0084|TWO_SIDED|95.0|1.39|9.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||9.20|1.39|0.0084
71141196|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|5.71||||0.0007|TWO_SIDED|95.0|2.09|15.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||15.62|2.09|0.0007
71141197|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|5.11||||0.0015|TWO_SIDED|95.0|1.87|14.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||14.00|1.87|0.0015
71141198|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|1.2||||0.6976|TWO_SIDED|95.0|0.48|2.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||2.95|0.48|0.6976
71141199|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|4.57||||0.0021|TWO_SIDED|95.0|1.73|12.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||12.05|1.73|0.0021
71141200|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|3.06||||0.0171|TWO_SIDED|95.0|1.22|7.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||7.68|1.22|0.0171
71141201|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|1.86||||0.2224|TWO_SIDED|95.0|0.69|5.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.04|0.69|0.2224
71141202|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|1.74||||0.2716|TWO_SIDED|95.0|0.65|4.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||4.69|0.65|0.2716
71141203|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|4.49||||0.0112|TWO_SIDED|95.0|1.41|14.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||14.32|1.41|0.0112
71141204|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|3.08||||0.0461|TWO_SIDED|95.0|1.02|9.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||9.31|1.02|0.0461
71141205|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|1.63||||0.3463|TWO_SIDED|95.0|0.59|4.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||4.47|0.59|0.3463
71141206|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|3.05||||0.0419|TWO_SIDED|95.0|1.04|8.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.92|1.04|0.0419
71141207|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|1.68||||0.2977|TWO_SIDED|95.0|0.63|4.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||4.46|0.63|0.2977
71141208|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|1.87||||0.23|TWO_SIDED|95.0|0.67|5.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||5.21|0.67|0.2300
71141209|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|2.83||||0.0655|TWO_SIDED|95.0|0.94|8.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.58|0.94|0.0655
71141210|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|3.79||||0.0245|TWO_SIDED|95.0|1.19|12.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||12.11|1.19|0.0245
71141211|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|5.62||||0.0129|TWO_SIDED|95.0|1.44|21.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||21.93|1.44|0.0129
71141212|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|2.37||||0.1259|TWO_SIDED|95.0|0.79|7.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.15|0.79|0.1259
70949340|NCT01667549|141400318|OTHER|Repeated Measures ANOVA were done with type of cereal as within-subjects and experimental group as grouping factors. When significant, planned comparisons were carried out. ANOVAs with a priori contrasts specified determined whether 1-month exposure differed from the no-exposure control (timing hypothesis). ANOVAs with a priori contrasts specified determined whether 1-month differed from 3-months exposure and whether these groups differed from no-exposure control (duration hypothesis).||||||0.02||||||Bonferroni adjustment was made and only planned pairwise comparisons with calculated p values of 0.02 or lower significant.|planned comparison|Bonferroni adjustment was calculated and only planned pair-wise comparisons with calculated p value 0.02 or lower were considered significant.||Separate analyses of variance with a priori contrasts specified were conducted: 1) to determine whether the 1-month exposure groups (1M0.5, 1M1.5, and 1M2.5) differed from the no-exposure control group to test the hypothesis that the timing of exposure affected acceptance; and 2) to determine whether 1 month of exposure differed from 3 months (1M0.5, 3M0.5 groups) and whether these groups differed from the no-exposure control group (duration hypothesis).||||0.02
70949341|NCT01667549|141400319|OTHER||||||<|0.02|||||||ANOVA|||Repeated measures ANOVAs were conducted on maternal gLMS ratings with type of juice and time as the within-subject factors and experimental group as the grouping factor||||<0.02
71141213|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|2.4||||0.1015|TWO_SIDED|95.0|0.84|6.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.82|0.84|0.1015
71141214|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|4.48||||0.0167|TWO_SIDED|95.0|1.31|15.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||15.33|1.31|0.0167
71141215|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|1.4||||0.5232|TWO_SIDED|95.0|0.5|3.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||3.95|0.50|0.5232
71141216|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|2.0||||0.2055|TWO_SIDED|95.0|0.68|5.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.82|0.68|0.2055
71141217|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|3.0||||0.0658|TWO_SIDED|95.0|0.93|9.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||9.64|0.93|0.0658
71141218|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|7.34||||0.0136|TWO_SIDED|95.0|1.51|35.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||35.75|1.51|0.0136
71141219|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|1.71||||0.3238|TWO_SIDED|95.0|0.59|5.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.00|0.59|0.3238
71141220|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|5.86||||0.0118|TWO_SIDED|95.0|1.48|23.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||23.21|1.48|0.0118
71141221|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|5.29||||0.0163|TWO_SIDED|95.0|1.36|20.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||20.62|1.36|0.0163
71141222|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|1.32||||0.6363|TWO_SIDED|95.0|0.42|4.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.18|0.42|0.6363
71141223|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|3.68||||0.0722|TWO_SIDED|95.0|0.89|15.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||15.25|0.89|0.0722
71141224|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|2.35||||0.2019|TWO_SIDED|95.0|0.63|8.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.73|0.63|0.2019
71141225|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|10.15||||0.0337|TWO_SIDED|95.0|1.2|86.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||86.09|1.20|0.0337
71141226|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|2.25||||0.2207|TWO_SIDED|95.0|0.61|8.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.24|0.61|0.2207
71141227|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|3.5||||0.0849|TWO_SIDED|95.0|0.84|14.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||14.57|0.84|0.0849
71141228|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|3.47||||0.0844|TWO_SIDED|95.0|0.84|14.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||14.24|0.84|0.0844
71141229|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|2.15||||0.2383|TWO_SIDED|95.0|0.6|7.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.65|0.60|0.2383
71141230|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|2.55||||0.1653|TWO_SIDED|95.0|0.68|9.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.58|0.68|0.1653
71141231|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|2.48||||0.1836|TWO_SIDED|95.0|0.65|9.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.48|0.65|0.1836
71141232|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|8.3||||0.0529|TWO_SIDED|95.0|0.97|70.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||70.80|0.97|0.0529
71141233|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|1.95||||0.3197|TWO_SIDED|95.0|0.52|7.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.27|0.52|0.3197
71141234|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|5.88||||0.0376|TWO_SIDED|95.0|1.11|31.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||31.25|1.11|0.0376
71141235|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|10.08||||0.0343|TWO_SIDED|95.0|1.19|85.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||85.64|1.19|0.0343
71141236|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|1.58||||0.4435|TWO_SIDED|95.0|0.49|5.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.09|0.49|0.4435
71141237|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|2.34||||0.1805|TWO_SIDED|95.0|0.67|8.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||8.13|0.67|0.1805
71141238|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|3.54||||0.0857|TWO_SIDED|95.0|0.84|14.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||14.95|0.84|0.0857
71141239|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|10.5||||0.0316|TWO_SIDED|95.0|1.23|89.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||89.63|1.23|0.0316
71141240|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|1.81||||0.3471|TWO_SIDED|95.0|0.52|6.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.27|0.52|0.3471
71141241|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|6.15||||0.0313|TWO_SIDED|95.0|1.18|32.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||32.09|1.18|0.0313
71141242|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|12.49||||0.0208|TWO_SIDED|95.0|1.47|106.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||106.3|1.47|0.0208
71141243|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8669|TWO_SIDED|95.0|0.31|3.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.97|0.31|0.8669
71141244|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|1.34||||0.6592|TWO_SIDED|95.0|0.37|4.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.89|0.37|0.6592
71141245|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|2.23||||0.2923|TWO_SIDED|95.0|0.5|9.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||9.98|0.50|0.2923
71141246|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|5.78||||0.1145|TWO_SIDED|95.0|0.65|51.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||51.04|0.65|0.1145
71141247|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|1.77||||0.447|TWO_SIDED|95.0|0.4|7.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.78|0.40|0.4470
71141248|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|7.31||||0.0753|TWO_SIDED|95.0|0.82|65.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||65.41|0.82|0.0753
71141249|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|6.85||||0.0829|TWO_SIDED|95.0|0.78|60.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||60.24|0.78|0.0829
71141250|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9978|TWO_SIDED|95.0|0.28|3.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.59|0.28|0.9978
71141251|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|1.68||||0.4571|TWO_SIDED|95.0|0.43|6.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.65|0.43|0.4571
71141252|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|1.99||||0.3681|TWO_SIDED|95.0|0.44|8.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.94|0.44|0.3681
71141253|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|6.12||||0.1038|TWO_SIDED|95.0|0.69|54.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||54.38|0.69|0.1038
71141254|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|1.74||||0.4639|TWO_SIDED|95.0|0.39|7.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||7.72|0.39|0.4639
71141255|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|7.15||||0.077|TWO_SIDED|95.0|0.81|63.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||63.27|0.81|0.0770
70949342|NCT01667549|141400320|OTHER|Repeated Measures ANOVA were done with type of cereal as within-subjects and experimental group as grouping factors. When significant, planned comparisons were carried out. ANOVAs with a priori contrasts specified determined whether 1-month exposure differed from the no-exposure control (timing hypothesis). ANOVAs with a priori contrasts specified determined whether 1-month differed from 3-months exposure and whether these groups differed from no-exposure control (duration hypothesis).|||||<|0.02||||||Because three comparisons were made for each outcome measure, a Bonferroni adjustment was calculated and only planned comparison with P's\<0.02 were considered significant.|planned comparison|a Bonferroni adjustment was calculated and only planned comparison with P's\<0.02 were considered significant.||Separate analyses of variance with a priori contrasts specified were conducted: 1) to determine whether the 1-month exposure groups (1M0.5, 1M1.5, and 1M2.5) differed from the no-exposure control group to test the hypothesis that the timing of exposure affected acceptance; and 2) to determine whether 1 month of exposure differed from 3 months (1M0.5, 3M0.5 groups) and whether these groups differed from the no-exposure control group (duration hypothesis).||||<0.02
70949343|NCT01667549|141400321|OTHER||||||<|0.02||||||Because three comparisons were made for each outcome measure, a Bonferroni adjustment was calculated and only planned comparison with P\<0.02 were considered significant.|planned comparison|A Bonferroni adjustment was calculated and only planned comparison with P's\<0.02 were considered significant.||Separate analyses of variance with a priori contrasts specified 1) to determine whether the 1-month exposure groups (1M0.5, 1M1.5, and 1M2.5) differed from the no-exposure control group to test the hypothesis that the timing of exposure affected acceptance; and 2) to determine whether 1 month of exposure differed from 3 months (1M0.5, 3M0.5 groups) and whether these groups differed from the no-exposure control group (duration hypothesis).||||<0.02
70949344|NCT01667549|141400322|OTHER||||||<|0.05|||||||ANOVA|||General linear models were conducted on WLZ scores with time as the within-subjects factor and Group as the between-subjects factor to determine there were differences in growth of the infants over time. This was not done to test hypothesis but to monitor growth of infants during course of trial.||||<0.05
70949345|NCT02844777|141400332|OTHER|||||||0.9518|||||||ANCOVA|||||||0.9518
70949346|NCT02844777|141400332|OTHER|||||||0.2458|||||||ANCOVA|||||||0.2458
70949347|NCT02844777|141400333|OTHER|||||||0.6201|||||||Fisher Exact|||||||0.6201
70949348|NCT02844777|141400333|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
70949349|NCT02844777|141400334|OTHER|||||||0.2912|||||||ANCOVA|||||||0.2912
70949350|NCT02844777|141400334|OTHER|||||||0.4168|||||||ANCOVA|||||||0.4168
70949351|NCT02844777|141400335|OTHER|||||||0.6458|||||||ANCOVA|||||||0.6458
71141256|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9838|TWO_SIDED|95.0|0.26|4.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.01|0.26|0.9838
70949352|NCT02844777|141400335|OTHER|||||||0.0721|||||||ANCOVA|||||||0.0721
70949353|NCT02844777|141400336|OTHER|||||||0.42|||||||ANCOVA|||||||0.4200
70949354|NCT02844777|141400336|OTHER|||||||0.0241|||||||ANCOVA|||||||0.0241
71141257|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|0.77||||0.6995|TWO_SIDED|95.0|0.21|2.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||2.86|0.21|0.6995
71141258|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|1.12||||0.8808|TWO_SIDED|95.0|0.26|4.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.71|0.26|0.8808
70949355|NCT00150618|141400337|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0041||95.0|||||ANCOVA|||||||0.0041
70949356|NCT00150618|141400337|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0176||95.0|||||ANCOVA|||||||0.0176
70949357|NCT00150618|141400337|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0016||95.0|||||ANCOVA|||||||0.0016
70949358|NCT00150618|141400337|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006||95.0|||||ANCOVA|||||||0.0006
70949359|NCT00150618|141400338|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||ANCOVA|||||||0.0010
70949360|NCT00150618|141400338|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0468||95.0|||||ANCOVA|||||||0.0468
70949361|NCT00150618|141400338|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||95.0|||||ANCOVA|||||||0.0056
71141259|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|4.94||||0.157|TWO_SIDED|95.0|0.54|45.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||45.13|0.54|0.1570
70949362|NCT00150618|141400338|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0237||95.0|||||ANCOVA|||||||0.0237
70949363|NCT00150618|141400339|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0074||95.0|||||Cochran-Mantel-Haenszel|||||||0.0074
70949364|NCT00150618|141400339|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1404||95.0|||||Cochran-Mantel-Haenszel|||||||0.1404
70949365|NCT00150618|141400339|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0055||95.0|||||Cochran-Mantel-Haenszel|||||||0.0055
70949366|NCT00150618|141400339|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0041||95.0|||||Cochran-Mantel-Haenszel|||||||0.0041
70949367|NCT00150618|141400340|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0303||95.0|||||Cochran-Mantel-Haenszel|||||||0.0303
70949368|NCT00150618|141400340|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4982||95.0|||||Cochran-Mantel-Haenszel|||||||0.4982
70949369|NCT00150618|141400340|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017||95.0|||||Cochran-Mantel-Haenszel|||||||0.0017
70949370|NCT00150618|141400340|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0063||95.0|||||Cochran-Mantel-Haenszel|||||||0.0063
70949371|NCT00150618|141400341|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0383||95.0|||||ANCOVA|||Psychosocial category||||0.0383
70949372|NCT00150618|141400341|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5859||95.0|||||ANCOVA|||Psychosocial category||||0.5859
70949373|NCT00150618|141400341|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2136||95.0|||||ANCOVA|||Psychosocial category||||0.2136
70949374|NCT00150618|141400341|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1483||95.0|||||ANCOVA|||Psychosocial category||||0.1483
70949375|NCT00855413|141400378|OTHER|one sided ANOVA.|Mean Difference (Final Values)|4.23|STANDARD_DEVIATION|0.15||0.03|TWO_SIDED|||||The degrees of freedom (df) for the within factor (number of visits - 1) was 2, and the second df is the error df of 17.|ANOVA|||An overall summary score of neurocognitive functioning was created by averaging all tests. Best available demographically corrected normative data were utilized to create z scores and then deficit scores for impairment ratings.Change in neurocognitive functioning was analyzed using a one sided repeated measures ANOVA with neurocognitive performance as the dependent variable (total z score) and time (visit) as the independent variable. Degrees of freedom were 2,17.||||0.03
70949376|NCT00855413|141400380|OTHER|Spearman correlation|spearman correlation|-0.82|||<|0.005|TWO_SIDED|||||R = -0.82|Spearman correlation|||Correlation between time (days) to HIV RNA suppression \<200 copies/mL and total z score (mean) was assessed by Spearman correlation|Correlation between time (days) to HIV RNA suppression \<200 copies/mL and total z score (mean) was assessed by Spearman correlation|||<.005
71141260|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|2.19||||0.3742|TWO_SIDED|95.0|0.39|12.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||12.26|0.39|0.3742
71141261|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|5.24||||0.1436|TWO_SIDED|95.0|0.57|48.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||48.26|0.57|0.1436
71141262|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|5.57||||0.1277|TWO_SIDED|95.0|0.61|50.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||50.77|0.61|0.1277
71141263|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|0.75||||0.6689|TWO_SIDED|95.0|0.2|2.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||2.81|0.20|0.6689
71141264|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|1.2||||0.8019|TWO_SIDED|95.0|0.29|4.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.95|0.29|0.8019
71141265|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|0.96||||0.9591|TWO_SIDED|95.0|0.23|4.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.05|0.23|0.9591
71141266|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|2.33||||0.3364|TWO_SIDED|95.0|0.42|13.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||13.06|0.42|0.3364
71141267|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|2.2||||0.3698|TWO_SIDED|95.0|0.39|12.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||12.32|0.39|0.3698
71141268|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|4.92||||0.1587|TWO_SIDED|95.0|0.54|45.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||45.01|0.54|0.1587
71141269|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|5.5||||0.13|TWO_SIDED|95.0|0.61|50.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||50.06|0.61|0.1300
71141270|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|1.81||||0.4152|TWO_SIDED|95.0|0.43|7.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.53|0.43|0.4152
71141271|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9645|TWO_SIDED|95.0|0.27|3.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.50|0.27|0.9645
71141272|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|1.95||||0.3884|TWO_SIDED|95.0|0.43|8.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.96|0.43|0.3884
70949377|NCT00825305|141400382|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis states that the Zagreb schedule is inferior to the Essen schedule in terms of day 14 antibody titers assuming no difference between the two schedules and the equivalence limit of 1.5 titer levels (log2).|ratio of log2 mean|-0.2|||||TWO_SIDED|95.0|-0.81|0.4|||ANOVA||Ratio of log2 mean (Zagreb/Essen) on day 14|||0.4|-0.81|
70949378|NCT00825305|141400383|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis states that the Zagreb schedule is inferior to the Essen schedule in terms of day 7 antibody titers assuming no difference between the two schedules and the equivalence limit of 1.5 titer levels (log2).|ratio of log2 mean (day7)|-0.21|||||TWO_SIDED|95.0|-0.77|0.35|||ANOVA||Ratio of log2 means (Zagreb/Essen) on day 7|||0.35|-0.77|
70949379|NCT00825305|141400383|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis states that the Zagreb schedule is inferior to the Essen schedule in terms of day 42 antibody titers assuming no difference between the two schedules and the equivalence limit of 1.5 titer levels (log2).|ratio of log2 mean (day 42)|-0.07|||||TWO_SIDED|95.0|-0.72|0.58|||ANOVA||Ratio of log2 mean (Zagreb/(Essen) on day 42|||0.58|-0.72|
70949380|NCT03617289|141400391|SUPERIORITY|||||||0.771||||||Threshold for statistical significance set at p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.771
70949381|NCT03617289|141400392|SUPERIORITY||||||<|0.046||||||Threshold for statistical significance was set at p\<0.05|Chi-squared|||||||<0.046
70949382|NCT02493946|141400393|SUPERIORITY||Treatment difference|80.8|||<|0.0001|TWO_SIDED|95.0|73.7|88.0||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders.||88.0|73.7|<0.0001
70949383|NCT02493946|141400394|SUPERIORITY||Treatment difference|75.0|||<|0.0001|TWO_SIDED|95.0|67.1|82.8||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 8 Cycle 1.||82.8|67.1|<0.0001
71141273|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|2.62||||0.267|TWO_SIDED|95.0|0.48|14.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||14.41|0.48|0.2670
71141274|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|6.91||||0.0861|TWO_SIDED|95.0|0.76|62.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||62.90|0.76|0.0861
70949384|NCT02493946|141400394|SUPERIORITY||Treatment difference|74.1|||<|0.0001|TWO_SIDED|95.0|66.2|82.1||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 57 Cycle 1.||82.1|66.2|<0.0001
70949385|NCT02493946|141400394|SUPERIORITY||Treatment difference|53.6|||<|0.0001|TWO_SIDED|95.0|44.2|63.1||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 85 Cycle 1.||63.1|44.2|<0.0001
70949386|NCT02493946|141400396|SUPERIORITY||Treatment difference|58.0|||<|0.0001|TWO_SIDED|95.0|44.5|71.6||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 8 Cycle 1.||71.6|44.5|<0.0001
70949387|NCT02493946|141400396|SUPERIORITY||Treatment difference|56.8|||<|0.0001|TWO_SIDED|95.0|44.5|69.0||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 29 Cycle 1.||69.0|44.5|<0.0001
70949388|NCT02493946|141400396|SUPERIORITY||Treatment difference|62.5|||<|0.0001|TWO_SIDED|95.0|52.1|72.9||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 57 Cycle 1.||72.9|52.1|<0.0001
70949389|NCT02493946|141400396|SUPERIORITY||Treatment difference|42.6|||<|0.0001|TWO_SIDED|95.0|29.5|55.7||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 85 Cycle 1.||55.7|29.5|<0.0001
70949390|NCT02493946|141400397|SUPERIORITY||Treatment difference|61.1|||<|0.0001|TWO_SIDED|95.0|51.9|70.3||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 8 Cycle 1.||70.3|51.9|<0.0001
71141275|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|7.21||||0.0774|TWO_SIDED|95.0|0.8|64.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||64.66|0.80|0.0774
71141276|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|4.73||||0.0389|TWO_SIDED|95.0|1.08|20.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||20.65|1.08|0.0389
71141277|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|1.81||||0.3695|TWO_SIDED|95.0|0.5|6.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.57|0.50|0.3695
70949391|NCT02493946|141400397|SUPERIORITY||Treatment difference|65.8|||<|0.0001|TWO_SIDED|95.0|56.8|74.8||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 29 Cycle 1.||74.8|56.8|<0.0001
70949392|NCT02493946|141400397|SUPERIORITY||Treatment difference|70.5|||<|0.0001|TWO_SIDED|95.0|62.2|78.8||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 57 Cycle 1.||78.8|62.2|<0.0001
70949393|NCT02493946|141400397|SUPERIORITY||Treatment difference|33.0|||<|0.0001|TWO_SIDED|95.0|24.0|42.0||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 85 Cycle 1.||42.0|24.0|<0.0001
71141278|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|1.95||||0.3501|TWO_SIDED|95.0|0.48|7.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.89|0.48|0.3501
70866781|NCT00705289|141220072|SUPERIORITY_OR_OTHER||Mean Baseline DAS28 Raw Score|5.3|STANDARD_DEVIATION|1.16||||95.0|5.0|5.5||||||Relationship between Baseline DAS28 and previous anti-TNF therapy (subjects with early RA, not treated with anti-TNF; prior to infliximab therapy)||5.5|5.0|
70949394|NCT02493946|141400398|SUPERIORITY||Treatment difference|68.2|||<|0.0001|TWO_SIDED|95.0|58.2|78.3||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Linear|||Treatment difference against placebo in the adjusted percentage of responders at Day 8 Cycle 1.||78.3|58.2|<0.0001
70949395|NCT02493946|141400398|SUPERIORITY||Treatment difference|77.4|||<|0.0001|TWO_SIDED|95.0|68.6|86.2||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 29 Cycle 1.||86.2|68.6|<0.0001
70949396|NCT02493946|141400398|SUPERIORITY||Treatment difference|74.4|||<|0.0001|TWO_SIDED|95.0|65.7|83.1||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 57 Cycle 1.||83.1|65.7|<0.0001
71141279|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|2.49||||0.2021|TWO_SIDED|95.0|0.61|10.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||10.14|0.61|0.2021
70949397|NCT02493946|141400398|SUPERIORITY||Treatment difference|51.0|||<|0.0001|TWO_SIDED|95.0|42.0|59.9||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 85 Cycle 1.||59.9|42.0|<0.0001
70949398|NCT02493946|141400399|SUPERIORITY||Hazard Ratio (HR)|15.296|||<|0.0001|TWO_SIDED||||||Cox proportional hazard model|The cox proportional hazard model used centre, gender and ILA baseline severity score as covariates.||Treatment difference in median time to onset of treatment response.||||<0.0001
70949399|NCT02493946|141400400|SUPERIORITY||Treatment difference|8.6|||<|0.0001|TWO_SIDED|95.0|5.2|12.0||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariates.|General linear model|||Treatment difference ( BTX-A-HAC Solution - Placebo) at Day 8 Cycle 1.||12.0|5.2|<0.0001
70949400|NCT02493946|141400400|SUPERIORITY||Treatment difference|11.1|||<|0.0001|TWO_SIDED|95.0|7.4|14.8||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariates.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 29 Cycle 1.||14.8|7.4|<0.0001
70949401|NCT02493946|141400400|SUPERIORITY||Treatment difference|10.4|||<|0.0001|TWO_SIDED|95.0|6.8|14.0||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariates.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 57 Cycle 1.||14.0|6.8|<0.0001
70949402|NCT02493946|141400400|SUPERIORITY||Treatment difference|9.6|||<|0.0001|TWO_SIDED|95.0|5.9|13.3||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariates.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 85 Cycle 1.||13.3|5.9|<0.0001
70949403|NCT02493946|141400401|SUPERIORITY||Treatment difference|9.3|||<|0.0001|TWO_SIDED|95.0|5.0|13.6||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 8 Cycle 1.||13.6|5.0|<0.0001
70949404|NCT02493946|141400401|SUPERIORITY||Treatment difference|11.4|||<|0.0001|TWO_SIDED|95.0|6.7|16.0||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 29 Cycle 1.||16.0|6.7|<0.0001
70949405|NCT02493946|141400401|SUPERIORITY||Treatment difference|11.2|||<|0.0001|TWO_SIDED|95.0|6.4|15.9||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 57 Cycle 1.||15.9|6.4|<0.0001
70949406|NCT02493946|141400401|SUPERIORITY||Treatment difference|8.1||||0.0004|TWO_SIDED|95.0|3.7|12.6||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 85 Cycle 1.||12.6|3.7|0.0004
70949407|NCT02493946|141400402|SUPERIORITY||Treatment difference|-0.6||||0.0174|TWO_SIDED|95.0|-1.1|-0.1||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 8 Cycle 1.||-0.1|-1.1|0.0174
70949408|NCT02493946|141400402|SUPERIORITY||Treatment difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.6||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 29 Cycle 1.||-0.6|-1.7|<0.0001
70949409|NCT02493946|141400402|SUPERIORITY||Treatment difference|-1.4||||0.0001|TWO_SIDED|95.0|-2.0|-0.7||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 57 Cycle 1.||-0.7|-2.0|0.0001
71141280|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|1.42||||0.6201|TWO_SIDED|95.0|0.36|5.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.62|0.36|0.6201
71141281|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|13.71||||0.0235|TWO_SIDED|95.0|1.42|132.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||132.0|1.42|0.0235
71141282|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|3.43||||0.0929|TWO_SIDED|95.0|0.81|14.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||14.48|0.81|0.0929
71141283|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|0.99||||0.982|TWO_SIDED|95.0|0.29|3.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.33|0.29|0.9820
71141284|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|1.55||||0.4956|TWO_SIDED|95.0|0.44|5.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.41|0.44|0.4956
71141285|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|0.7||||0.5708|TWO_SIDED|95.0|0.2|2.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.44|0.20|0.5708
71141286|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|2.55||||0.1985|TWO_SIDED|95.0|0.61|10.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||10.61|0.61|0.1985
71141287|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|1.15||||0.8368|TWO_SIDED|95.0|0.31|4.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.32|0.31|0.8368
70866782|NCT00705289|141220072|SUPERIORITY_OR_OTHER||Mean Baseline DAS28 Raw Score|5.2|STANDARD_DEVIATION|1.14||||95.0|5.1|5.3||||||Relationship between Baseline DAS28 and previous anti-TNF therapy (subjects with established RA not treated with anti-TNF; prior to infliximab therapy)||5.3|5.1|
71141288|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|3.18||||0.1397|TWO_SIDED|95.0|0.68|14.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||14.76|0.68|0.1397
71141289|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|1.88||||0.0366|TWO_SIDED|95.0|0.52|6.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||6.85|0.52|0.0366
71141290|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|0.84||||0.7968|TWO_SIDED|95.0|0.23|3.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.05|0.23|0.7968
71141291|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9074|TWO_SIDED|95.0|0.3|3.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.81|0.30|0.9074
71141292|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|0.41||||0.1987|TWO_SIDED|95.0|0.1|1.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.60|0.10|0.1987
71141293|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|2.58||||0.204|TWO_SIDED|95.0|0.6|11.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||11.18|0.60|0.2040
71141294|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|0.51||||0.3318|TWO_SIDED|95.0|0.13|1.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.99|0.13|0.3318
71141295|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|1.26||||0.7437|TWO_SIDED|95.0|0.31|5.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.10|0.31|0.7437
71141296|NCT03192176|141778533|SUPERIORITY||Odds Ratio (OR)|1.3||||0.6848|TWO_SIDED|95.0|0.36|4.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||4.71|0.36|0.6848
71141297|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|2.12||||0.1114|TWO_SIDED|95.0|0.84|5.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||5.32|0.84|0.1114
71141298|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|4.69||||0.0013|TWO_SIDED|95.0|1.83|12.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||12.04|1.83|0.0013
70866783|NCT00705289|141220072|SUPERIORITY_OR_OTHER||Mean Baseline DAS28 Raw Score|5.3|STANDARD_DEVIATION|1.16||||95.0|5.1|5.5||||||Relationship between Baseline DAS28 and previous anti-TNF therapy (subjects with established RA who failed or did not tolerate another anti-TNF; prior to infliximab therapy)||5.5|5.1|
71141299|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|7.01|||<|0.0001|TWO_SIDED|95.0|2.65|18.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||18.54|2.65|<0.0001
71141300|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|4.96||||0.001|TWO_SIDED|95.0|1.91|12.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||12.89|1.91|0.0010
71141301|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|1.25||||0.6384|TWO_SIDED|95.0|0.49|3.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||3.22|0.49|0.6384
70866784|NCT02609828|141220089|SUPERIORITY||Differences in least square (LS) mean|-0.78|STANDARD_ERROR_OF_MEAN|0.37||0.0381|TWO_SIDED|95.0|-1.52|-0.04|||ANCOVA|||Change at Week 8: Analysis of covariance (ANCOVA) model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.04|-1.52|0.0381
71141302|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|5.77||||0.0003|TWO_SIDED|95.0|2.23|14.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||14.93|2.23|0.0003
70866785|NCT02609828|141220090|SUPERIORITY||Difference in LS mean|-0.36|STANDARD_ERROR_OF_MEAN|0.18||0.0497|TWO_SIDED|95.0|-0.72|0.0|||ANCOVA|||Change at Week 1: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.00|-0.72|0.0497
71141303|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|4.15||||0.0025|TWO_SIDED|95.0|1.65|10.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||10.45|1.65|0.0025
71141304|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|2.82||||0.0279|TWO_SIDED|95.0|1.12|7.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.12|1.12|0.0279
71141305|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|3.36||||0.0114|TWO_SIDED|95.0|1.31|8.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.61|1.31|0.0114
71141306|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|7.55||||0.0001|TWO_SIDED|95.0|2.66|21.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||21.45|2.66|0.0001
71141307|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|6.41||||0.0005|TWO_SIDED|95.0|2.25|18.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||18.26|2.25|0.0005
71141308|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|2.37||||0.0695|TWO_SIDED|95.0|0.93|6.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.02|0.93|0.0695
71141309|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|4.83||||0.0015|TWO_SIDED|95.0|1.83|12.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.77|1.83|0.0015
71141310|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|3.28||||0.012|TWO_SIDED|95.0|1.3|8.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.28|1.30|0.0120
71141311|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|2.49||||0.662|TWO_SIDED|95.0|0.94|6.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.57|0.94|0.662
71141312|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|2.22||||0.1019|TWO_SIDED|95.0|0.85|5.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||5.80|0.85|0.1019
71141313|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|5.44||||0.0023|TWO_SIDED|95.0|1.83|16.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||16.18|1.83|0.0023
71141314|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|7.33||||0.0015|TWO_SIDED|95.0|2.15|25.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||25.02|2.15|0.0015
71141315|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|1.78||||0.238|TWO_SIDED|95.0|0.68|4.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||4.66|0.68|0.2380
71141316|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|3.61||||0.012|TWO_SIDED|95.0|1.33|9.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.81|1.33|0.0120
71141317|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|2.25||||0.091|TWO_SIDED|95.0|0.88|5.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||5.77|0.88|0.0910
70949410|NCT02493946|141400402|SUPERIORITY||Treatment difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-2.1|-0.8||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 85 Cycle 1.||-0.8|-2.1|<0.0001
70866786|NCT02609828|141220090|SUPERIORITY||Difference in LS mean|-0.66|STANDARD_ERROR_OF_MEAN|0.25||0.0092|TWO_SIDED|95.0|-1.16|-0.17|||ANCOVA|||Change at Week 2: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.17|-1.16|0.0092
70866787|NCT02609828|141220090|SUPERIORITY||Difference in LS mean|-0.74|STANDARD_ERROR_OF_MEAN|0.32||0.0218|TWO_SIDED|95.0|-1.37|-0.11|||ANCOVA|||Change at Week 4: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.11|-1.37|0.0218
70866788|NCT02609828|141220090|SUPERIORITY||Difference in LS mean|-0.87|STANDARD_ERROR_OF_MEAN|0.36||0.0154|TWO_SIDED|95.0|-1.58|-0.17|||ANCOVA|||Change at Week 6: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.17|-1.58|0.0154
70866789|NCT02609828|141220090|SUPERIORITY||Difference in LS mean|-0.59|STANDARD_ERROR_OF_MEAN|0.39||0.1289|TWO_SIDED|95.0|-1.36|0.17|||ANCOVA|||Change at Week 12: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.17|-1.36|0.1289
70866790|NCT02609828|141220090|SUPERIORITY||Difference in LS mean|-0.55|STANDARD_ERROR_OF_MEAN|0.44||0.211|TWO_SIDED|95.0|-1.43|0.32|||ANCOVA|||Change at Week 16: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.32|-1.43|0.2110
70866791|NCT02609828|141220090|SUPERIORITY||Difference in LS mean|-0.58|STANDARD_ERROR_OF_MEAN|0.46||0.2049|TWO_SIDED|95.0|-1.49|0.32|||ANCOVA|||Change at Week 24: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.32|-1.49|0.2049
70866792|NCT02609828|141220091|SUPERIORITY||Difference in LS mean|-0.33|STANDARD_ERROR_OF_MEAN|0.2||0.1103|TWO_SIDED|95.0|-0.73|0.07|||ANCOVA|||Change at Week 1: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.07|-0.73|0.1103
70866793|NCT02609828|141220091|SUPERIORITY||Difference in LS mean|-0.73|STANDARD_ERROR_OF_MEAN|0.27||0.0084|TWO_SIDED|95.0|-1.26|-0.19|||ANCOVA|||Change at Week 2: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.19|-1.26|0.0084
70866794|NCT02609828|141220091|SUPERIORITY||Difference in LS mean|-0.75|STANDARD_ERROR_OF_MEAN|0.33||0.0236|TWO_SIDED|95.0|-1.39|-0.1|||ANCOVA|||Change at Week 4:ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.10|-1.39|0.0236
70866795|NCT02609828|141220091|SUPERIORITY||Difference in LS mean|-0.88|STANDARD_ERROR_OF_MEAN|0.36||0.0155|TWO_SIDED|95.0|-1.59|-0.17|||ANCOVA|||Change at Week 6: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.17|-1.59|0.0155
70866796|NCT02609828|141220091|SUPERIORITY||Difference in LS mean|-0.76|STANDARD_ERROR_OF_MEAN|0.38||0.0505|TWO_SIDED|95.0|-1.52|0.0|||ANCOVA|||Change at Week 8: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.00|-1.52|0.0505
70866797|NCT02609828|141220091|SUPERIORITY||Difference in LS mean|-0.72|STANDARD_ERROR_OF_MEAN|0.4||0.0761|TWO_SIDED|95.0|-1.52|0.08|||ANCOVA|||Change at Week 12: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.08|-1.52|0.0761
70949411|NCT03355209|141400411|SUPERIORITY||Median Difference (A-P)|-19.88||||0.0008|TWO_SIDED|95.0|-31.02|-8.74|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann (HL) method|||-8.74|-31.02|0.0008
70949412|NCT03355209|141400414|SUPERIORITY||Median Difference (A-P)|-10.5||||0.146|TWO_SIDED|95.0|-24.99|3.99|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann (HL) method|||3.99|-24.99|0.1460
70949413|NCT03355209|141400415|SUPERIORITY||Odds Ratio (OR)|3.3||||0.0051|TWO_SIDED|95.0|1.43|7.59|||Regression, Logistic|||||7.59|1.43|0.0051
70949414|NCT03355209|141400415|SUPERIORITY||Odds Ratio (OR)|2.87||||0.015|TWO_SIDED|95.0|1.23|6.7|||Regression, Logistic|||||6.70|1.23|0.0150
70949415|NCT03355209|141400416|SUPERIORITY||Odds Ratio (OR)|1.58||||0.1565|TWO_SIDED|95.0|0.84|2.97|||Cochran-Mantel-Haenszel|||Visit 12||2.97|0.84|0.1565
70949416|NCT03355209|141400416|SUPERIORITY||Odds Ratio (OR)|1.86||||0.0567|TWO_SIDED|95.0|0.98|3.52|||Cochran-Mantel-Haenszel|||Visit 12||3.52|0.98|0.0567
70949417|NCT01727505|141400464|SUPERIORITY_OR_OTHER|||||||0.44|||||||Wilcoxon signed rank test|||||||0.44
70949418|NCT01727505|141400465|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon signed rank test|||||||.75
70949419|NCT01727505|141400466|SUPERIORITY_OR_OTHER|||||||0.2|||||||Wilcoxon signed rank test|||||||0.2
70949420|NCT01727505|141400467|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon signed rank test|||||||0.02
70949421|NCT01727505|141400468|SUPERIORITY_OR_OTHER|||||||0.049|||||||Wilcoxon signed rank test|||||||.049
70949422|NCT01727505|141400469|SUPERIORITY_OR_OTHER|||||||0.006|||||||Paired t-test|||||||0.006
71141318|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|1.93||||0.1926|TWO_SIDED|95.0|0.72|5.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.18|0.72|0.1926
70949423|NCT00358644|141400493|SUPERIORITY_OR_OTHER||Percentage of Participants|23.6||||||95.0|13.2|37.0||||||||37.0|13.2|
70949424|NCT01637077|141400533|SUPERIORITY|||||||0.56|||||||Kruskal-Wallis|||||||0.56
70949425|NCT01637077|141400534|SUPERIORITY|||||||0.48|||||||Kruskal-Wallis|||||||0.48
70949426|NCT01637077|141400535|SUPERIORITY|||||||0.62|||||||Kruskal-Wallis|||Worst pain over the past 24 hours||||0.62
70949427|NCT01637077|141400535|SUPERIORITY|||||||0.22|||||||Kruskal-Wallis|||Average pain over the past 24 hours||||0.22
70949428|NCT01637077|141400535|SUPERIORITY|||||||0.07|||||||Kruskal-Wallis|||Least pain over the past 24 hours||||0.07
70949429|NCT01637077|141400537|SUPERIORITY|||||||0.87|||||||Chi-squared|||||||0.87
70949430|NCT01637077|141400538|SUPERIORITY|||||||0.84|||||||Chi-squared|||||||0.84
70949431|NCT01637077|141400539|SUPERIORITY|||||||0.03|||||||Chi-squared|||||||0.03
70949432|NCT01637077|141400540|SUPERIORITY|||||||0.12|||||||Kruskal-Wallis|||||||0.12
70949433|NCT01637077|141400541|SUPERIORITY|||||||0.78|||||||Chi-squared|||||||0.78
70949434|NCT01637077|141400542|SUPERIORITY|||||||0.16|||||||Chi-squared|||||||0.16
70949435|NCT01637077|141400543|SUPERIORITY|||||||0.46|||||||Kruskal-Wallis|||Sensory neuropathy||||0.46
70949436|NCT01637077|141400543|SUPERIORITY|||||||0.86|||||||Kruskal-Wallis|||Autonomic neuropathy||||0.86
70949437|NCT01637077|141400543|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||Motor neuropathy||||0.40
70949438|NCT03332784|141400579|SUPERIORITY||||||<|0.0001||||||The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group.|ANOVA|||||||<0.0001
70949439|NCT03332784|141400579|SUPERIORITY||||||<|0.0001||||||The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group.|ANOVA|||||||<0.0001
70949440|NCT03332784|141400579|SUPERIORITY|||||||0.0001||||||The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group.|ANOVA|||||||0.0001
70949441|NCT01814072|141400611|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
70949442|NCT01814072|141400612|SUPERIORITY||Estimated Change|0.1244||||0.567|TWO_SIDED|95.0|-0.3026|0.5513|||Mixed Models Analysis|||||.5513|-.3026|0.567
70949443|NCT01814072|141400612|SUPERIORITY||Estimated Change|-0.0226||||0.917|TWO_SIDED|95.0|-0.4495|0.4044|||Mixed Models Analysis|||||.4044|-.4495|0.917
70949444|NCT01814072|141400612|SUPERIORITY||Estimated Change|0.084||||0.699|TWO_SIDED|95.0|-0.3429|0.5109|||Mixed Models Analysis|||||.5109|-.3429|0.699
70949445|NCT01814072|141400612|SUPERIORITY||Estimated Change|0.1081||||0.619|TWO_SIDED|95.0|-0.3188|0.535|||Mixed Models Analysis|||||.5350|-.3188|0.619
70949446|NCT01814072|141400612|SUPERIORITY||Estimated Change|-0.4353||||0.046|TWO_SIDED|95.0|-0.8622|-0.0084|||Mixed Models Analysis|||||-.0084|-.8622|0.046
70949447|NCT01814072|141400613|OTHER||Estimated Change|0.424||||0.051|TWO_SIDED|95.0|-0.002|0.85|||Mixed Models Analysis|||Using the results from primary aim 1, an intervention with only active treatment components with the largest treatment effect that can be obtained for implementation costs of $500 or less was identified and built.||0.850|-0.002|0.051
70949448|NCT01782690|141400638|SUPERIORITY_OR_OTHER|||||||0.2361|||||||Log Rank|||Comparison of Rash=Yes versus Rash=No within Erlotinib plus Gemcitabine arm||||0.2361
70949449|NCT04121897|141400661|OTHER|||||||0.024|||||||t-test, 2 sided|||||||0.024
70949450|NCT01948076|141400678|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.11
70949451|NCT01948076|141400679|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED|95.0|||||McNemar|||||||0.043
70949452|NCT03732677|141400714|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0005|TWO_SIDED|95.0|1.227|2.084|||Regression, Logistic|Strata adjusted odds ratio by the logistic regression method adjusting for stratification factors: renal function , tumor stage and PDL1 status .||||2.084|1.227|0.0005
70949453|NCT03732677|141400715|SUPERIORITY||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|95.877|0.554|824.0||Stratified by renal function(adequate vs borderline),tumor stage(T2N0 vs \>T2N0), PDL1 status(high vs low/negative)|Log Rank||The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for renal function (adequate vs borderline), tumor stage (T2N0 vs \>T2N0) and PDL1 status (high vs low/negative)||95% CI for hazard ratio: 0.558 - 0.817|0824|0.554|<0.0001
71141319|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|2.29||||0.1017|TWO_SIDED|95.0|0.85|6.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.15|0.85|0.1017
71141320|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|3.85||||0.0153|TWO_SIDED|95.0|1.29|11.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||11.45|1.29|0.0153
70949454|NCT03732677|141400716|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0021|TWO_SIDED|95.0|0.62|0.9|||Chi-squared|P-value is based on a chi-squared test with one degree of freedom.|The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for renal function (adequate vs borderline), tumor stage (T2N0 vs \>T2N0) and PDL1 status (high vs low/negative)|||0.90|0.62|0.0021
71141321|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|7.52||||0.0034|TWO_SIDED|95.0|1.95|28.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||28.98|1.95|0.0034
71141322|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|1.44||||0.4539|TWO_SIDED|95.0|0.55|3.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||3.76|0.55|0.4539
71141323|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|3.03||||0.0327|TWO_SIDED|95.0|1.1|8.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.40|1.10|0.0327
71141324|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|2.67||||0.0555|TWO_SIDED|95.0|0.98|7.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.30|0.98|0.0555
71141325|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|1.64||||0.3505|TWO_SIDED|95.0|0.58|4.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.67|0.58|0.3505
71141326|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|3.92||||0.0265|TWO_SIDED|95.0|1.17|13.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||13.11|1.17|0.0265
71141327|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|4.77||||0.0174|TWO_SIDED|95.0|1.32|17.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||17.32|1.32|0.0174
71141328|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|8.95||||0.0075|TWO_SIDED|95.0|1.8|44.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||44.61|1.80|0.0075
71141329|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|2.46||||0.1228|TWO_SIDED|95.0|0.78|7.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.68|0.78|0.1228
71141330|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|3.28||||0.0431|TWO_SIDED|95.0|1.04|10.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||10.38|1.04|0.0431
71141331|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0851|TWO_SIDED|95.0|0.87|8.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.35|0.87|0.0851
71141332|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|1.45||||0.4726|TWO_SIDED|95.0|0.53|3.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.99|0.53|0.4726
71141333|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|2.29||||0.1289|TWO_SIDED|95.0|0.79|6.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.67|0.79|0.1289
71141334|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|3.39||||0.04|TWO_SIDED|95.0|1.06|10.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||10.84|1.06|0.0400
71141335|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|8.22||||0.0097|TWO_SIDED|95.0|1.67|40.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||40.55|1.67|0.0097
71141336|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|1.97||||0.226|TWO_SIDED|95.0|0.66|5.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.94|0.66|0.2260
70949455|NCT03732677|141400717|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0265|TWO_SIDED|95.0|1.047|2.095|||Regression, Logistic|Stratified by renal function(adequate vs borderline),tumor stage(T2N0 vs \>T2N0), PDL1 status(high vs low/negative)|Strata adjusted odds ratio by the logistic regression method. Stratified by adjusting for renal function (adequate vs borderline), tumor stage (T2N0 vs \>T2N0) and PDL1 status (high vs low/negative).|||2.095|1.047|0.0265
70949456|NCT03732677|141400718|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0106|TWO_SIDED|98.457|0.563|0.985|||Log Rank|Stratified by renal function (adequate vs borderline),tumor stage(T2N0vs \>T2N0), PDL1 status(high vs low/negative)|||95% CI: 0.594 to 0.934|0.985|0.563|0.0106
70949457|NCT03732677|141400719|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.0002|TWO_SIDED|95.0|0.541|0.826|||Log Rank|Stratified by renal function(adequate vs borderline),tumor stage(T2N0 vs \>T2N0), PDL1 status(high vs low/negative)|The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for renal function (adequate vs borderline), tumor stage (T2N0 vs \>T2N0) and PDL1 status (high vs low/negative)|||0.826|0.541|0.0002
70949458|NCT03732677|141400720|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0081|TWO_SIDED|95.0|0.516|0.907|||Log Rank|Stratified by renal function(adequate vs borderline),tumor stage(T2N0 vs \>T2N0), PDL1 status(high vs low/negative)|The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for renal function (adequate vs borderline), tumor stage (T2N0 vs \>T2N0) and PDL1 status (high vs low/negative)|||0.907|0.516|0.0081
70949459|NCT05101993|141400761|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
70949460|NCT02065882|141400789|OTHER|Confirmatory t-test testing of the MCF difference (1 h post-dose minus pre-dose)|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70949461|NCT03258723|141400847|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Within group change from baseline assessed on matched cases.||||<0.0001
70949462|NCT03258723|141400848|SUPERIORITY|||||||0.0005|||||||t-test, 2 sided|||Within group change from baseline assessed on matched cases.||||0.0005
70949463|NCT03258723|141400849|SUPERIORITY|||||||0.1809|||||||t-test, 2 sided|||Within group change from baseline assessed on matched cases.||||0.1809
70949464|NCT03258723|141400850|SUPERIORITY|||||||0.0973|||||||t-test, 2 sided|||Within group change from baseline assessed on matched cases.||||0.0973
70949465|NCT03258723|141400852|SUPERIORITY|||||||0.1992|||||||t-test, 2 sided|||Within subject change on matched cases.||||0.1992
70949466|NCT03258723|141400853|SUPERIORITY|||||||0.7017|||||||t-test, 2 sided|||Within subject change on matched cases.||||0.7017
71141337|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|8.63||||0.0031|TWO_SIDED|95.0|2.07|35.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||35.96|2.07|0.0031
70949467|NCT03258723|141400854|SUPERIORITY|||||||0.1573|||||||McNemar|||Within group change from baseline assessed on matched cases in low activity group at baseline.||||0.1573
70949468|NCT03258723|141400854|SUPERIORITY|||||||0.4328|||||||McNemar|||Within group change from baseline assessed on matched cases in medium activity group at baseline.||||0.4328
70949469|NCT03258723|141400854|SUPERIORITY|||||||0.6698|||||||McNemar|||Within group change from baseline assessed on matched cases in high activity group at baseline.||||0.6698
70949470|NCT03258723|141400855|SUPERIORITY|||||||0.5271|||||||t-test, 2 sided|||Within group change from baseline assessed on matched cases.||||0.5271
70949471|NCT03258723|141400856|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Within group change from baseline assessed on matched cases.||||<0.0001
70949472|NCT00592293|141400858|OTHER||Cumulative incidence|17.0|||||TWO_SIDED|95.0|9.1|27.6||||||||27.6|9.1|
70949473|NCT00592293|141400859|OTHER||Percent Survival, Local Control|87.1|||||TWO_SIDED|95.0|78.1|93.7||||||||93.7|78.1|
70949474|NCT04292470|141400864|SUPERIORITY|||||||0.41|||||||ANOVA|||||||0.41
70949475|NCT04292470|141400865|SUPERIORITY|||||||0.09|||||||ANOVA|||For statistical testing, we used a general linear model of change in GERD symptoms from baseline to 8 weeks adjusted for the natural log of the index value (of the ratio of the change in skin conductance between patient and physician at baseline) and randomization assignment.||||0.09
70949476|NCT02906020|141400877|SUPERIORITY||LS mean difference|2.58|STANDARD_ERROR_OF_MEAN|1.87|=|0.1679|TWO_SIDED|95.0|-1.1|6.27||The threshold for statistical significance was 0.05.|MMRM|||Least-squares (LS) mean, standard errors (SE) and p-value were estimated from mixed-effect model with repeated measures (MMRM) analysis which included fixed categorical effects of treatment group, randomization strata, time point, treatment-by-time point and strata-by-time point interaction and continuous fixed covariates Baseline value and Baseline value-by-time point interaction.||6.27|-1.10|=0.1679
70949477|NCT02906020|141400878|SUPERIORITY||LS mean difference|-0.97|STANDARD_ERROR_OF_MEAN|1.85|=|0.5996|TWO_SIDED|95.0|-4.63|2.68||The threshold for statistical significance was 0.05.|MMRM|||LS mean, SE and P-value were estimated from MMRM analysis which included fixed categorical effects of treatment group, randomization strata, time point, treatment-by-time point and strata-by-time point interaction and continuous fixed covariates Baseline value and Baseline value-by-time point interaction.||2.68|-4.63|=0.5996
70949478|NCT02906020|141400879|SUPERIORITY||LS mean difference|4.13|STANDARD_ERROR_OF_MEAN|2.13|=|0.0535|TWO_SIDED|95.0|-0.06|8.32||The threshold for statistical significance was 0.05.|MMRM|||LS mean, SE and P-value were estimated from MMRM analysis which included fixed categorical effects of treatment group, randomization strata, time point, treatment-by-time point and strata-by-time point interaction and continuous fixed covariates Baseline value and Baseline value-by-time-interaction||8.32|-0.06|=0.0535
70949479|NCT02906020|141400880|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.08|=|0.74|TWO_SIDED|95.0|-0.12|0.17||The threshold for statistical significance was 0.05.|MMRM|||LS mean, SE and P-value: estimated from MMRM analysis which included fixed categorical effects of treatment group, randomization strata, time point, treatment-by-time point and strata-by-time point interaction and continuous fixed covariates Baseline value and Baseline value-by-time-interaction.||0.17|-0.12|=0.7400
71141338|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|10.16||||0.0043|TWO_SIDED|95.0|2.07|49.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||49.90|2.07|0.0043
70866798|NCT02609828|141220091|SUPERIORITY||Difference in LS mean|-0.74|STANDARD_ERROR_OF_MEAN|0.48||0.1263|TWO_SIDED|95.0|-1.7|0.21|||ANCOVA|||Change at Week 16: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.21|-1.70|0.1263
70866799|NCT02609828|141220091|SUPERIORITY||Difference in LS mean|-0.79|STANDARD_ERROR_OF_MEAN|0.49||0.1051|TWO_SIDED|95.0|-1.76|0.17|||ANCOVA|||Change at Week 24: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.17|-1.76|0.1051
70866800|NCT02609828|141220092|SUPERIORITY||Difference in LS mean|-0.5|STANDARD_ERROR_OF_MEAN|0.48||0.3003|TWO_SIDED|95.0|-1.47|0.47|||ANCOVA|||Change at Week 1: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.47|-1.47|0.3003
70866801|NCT02609828|141220092|SUPERIORITY||Difference in LS mean|-0.84|STANDARD_ERROR_OF_MEAN|0.59||0.1603|TWO_SIDED|95.0|-2.03|0.35|||ANCOVA|||Change at Week 2: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.35|-2.03|0.1603
70866802|NCT02609828|141220092|SUPERIORITY||Difference in LS mean|-0.8|STANDARD_ERROR_OF_MEAN|0.66||0.2298|TWO_SIDED|95.0|-2.13|0.53|||ANCOVA|||Change at Week 4: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.53|-2.13|0.2298
70866803|NCT02609828|141220092|SUPERIORITY||Difference in LS mean|-0.48|STANDARD_ERROR_OF_MEAN|0.72||0.5054|TWO_SIDED|95.0|-1.93|0.97|||ANCOVA|||Change at Week 6: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.97|-1.93|0.5054
70866804|NCT02609828|141220092|SUPERIORITY||Difference in LS mean|-0.55|STANDARD_ERROR_OF_MEAN|-0.77||0.4793|TWO_SIDED|95.0|-2.1|1.01|||ANCOVA|||Change at Week 8: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||1.01|-2.10|0.4793
70866805|NCT02609828|141220092|SUPERIORITY||Difference in LS mean|-0.5|STANDARD_ERROR_OF_MEAN|0.66||0.4496|TWO_SIDED|95.0|-1.83|0.83|||ANCOVA|||Change at Week 12: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.83|-1.83|0.4496
70949480|NCT03994731|141400931|SUPERIORITY||Stratified difference in proportions|32.31|STANDARD_ERROR_OF_MEAN|8.157|<|0.0001|TWO_SIDED|95.0|16.3|48.3||The 2-sided p-value was calculated assuming the test statistic was distributed as a standard normal random variable.|Cochran-Mantel-Haenszel||Stratified difference (Pegloticase+MTX - Pegloticase+Placebo) is a weighted average of the difference within each stratum. Estimates from the 2 strata (tophi presence at baseline: yes, no) were combined with Cochran-Mantel-Haenszel (CMH) weights.|||48.3|16.3|< 0.0001
70949481|NCT03994731|141400932|SUPERIORITY||response rate difference|29.05|STANDARD_ERROR_OF_MEAN|8.084||0.0003|TWO_SIDED|95.0|13.2|44.9||The 2-sided p-value was calculated assuming the test statistic was distributed as a standard normal random variable.|Cochran-Mantel-Haenszel||response rate difference (Peg+MTX - Peg+Placebo)|||44.9|13.2|0.0003
70866806|NCT02609828|141220092|SUPERIORITY||Difference in least square LS mean|-1.21|STANDARD_ERROR_OF_MEAN|0.77||0.1263|TWO_SIDED|95.0|-2.77|0.36|||ANCOVA|||Change at Week 16: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.36|-2.77|0.1263
70866807|NCT02609828|141220092|SUPERIORITY||Difference in LS mean|-1.05|STANDARD_ERROR_OF_MEAN|0.73||0.162|TWO_SIDED|95.0|-2.54|0.44|||ANCOVA|||Change at Week 24: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.44|-2.54|0.1620
70949482|NCT03994731|141400933|SUPERIORITY||Difference|22.8||||0.0482|TWO_SIDED|95.0|1.2|44.4||The comparison of complete response between groups is performed using an unstratified chi-squared test.|Chi-squared||Difference (Pegloticase+MTX - Pegloticase+Placebo)|||44.4|1.2|0.0482
70949483|NCT03994731|141400934|SUPERIORITY||Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.084||0.6287|TWO_SIDED|95.0|-0.21|0.13||Based on mixed models repeated measures (MMRM) analysis of covariance (ANCOVA) model including the following terms: baseline value, tophi presence (Y/N), treatment group, visit, visit-by-treatment interaction, and visit-by-baseline value interaction.|MMRM ANCOVA||Difference (Pegloticase+MTX - Pegloticase+Placebo)|||0.13|-0.21|0.6287
70949484|NCT03994731|141400935|SUPERIORITY||Difference|-8.43|STANDARD_ERROR_OF_MEAN|3.766||0.0272|TWO_SIDED|95.0|-15.88|-0.97||Based on mixed models repeated measures (MMRM) analysis of covariance (ANCOVA) model including the following terms: baseline value, tophi presence (Y/N), treatment group, visit, visit-by-treatment interaction, and visit-by-baseline value interaction.|MMRM ANCOVA||Difference (Pegloticase+MTX - Pegloticase+Placebo)|||-0.97|-15.88|0.0272
70949485|NCT03994731|141400936|SUPERIORITY||Difference|-10.16|STANDARD_ERROR_OF_MEAN|2.531||0.0222|TWO_SIDED|95.0|-18.84|-1.48||Based on mixed models repeated measures (MMRM) analysis of covariance (ANCOVA) model including the following terms: baseline value, tophi presence (Y/N), treatment group, visit, visit-by-treatment interaction, and visit-by-baseline value interaction.|MMRM ANCOVA||Difference (Pegloticase+MTX - Pegloticase+Placebo)|||-1.48|-18.84|0.0222
70949486|NCT00609947|141400937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.2|STANDARD_DEVIATION|21.8|<|0.001|ONE_SIDED|95.0||||"The null and alternative hypotheses were:~H0: µSVS ≥µM H1: µSVS \< µM where µSVS was the mean in-segment 8-month percent diameter stenosis for the SVS study and µM was the mean in-segment 6-month percent diameter stenosis for Micro-Driver."|t-test, 2 sided|The sample size was not reduced below 158 evaluable subjects in order to support the analysis of the primary safety endpoint.||The 8-month in-segment percent diameter stenosis from Endeavor SVS subjects was compared to the 6-month in-segment percent diameter stenosis from Micro Driver subjects. This study assessed the superiority of SVS against the Micro-Driver regarding in-segment percent diameter stenosis at 8 months post procedure.||||<0.001
70949487|NCT00609947|141400938|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|13.5|STANDARD_ERROR_OF_MEAN|6.5||0.0041|ONE_SIDED|95.0||20.0|||t-test, 1 sided|||"The null and alternative hypotheses of interest are:~H0: xSVS \>= 20% vs. H1: xSVS \< 20%, where x is the true SVS 12-month MACE rate.~The assessment of the null hypothesis will be carried out at the one-sided 0.05 level of significance. Rejection of the null hypothesis indicates the SVS 12-month MACE rate is significantly below 20%."||20||0.0041
70949488|NCT04148989|141400945|SUPERIORITY||Mean Difference (Final Values)|-12.8|||<|0.001|TWO_SIDED|95.0|-18.6|-7.0|||Regression, gamma||Change in emergency department door-to-antibiotic time (minutes) associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable gamma regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||-7.0|-18.6|<0.001
70949489|NCT04148989|141400946|SUPERIORITY||Odds Ratio (OR)|0.89||||0.45|TWO_SIDED|95.0|0.68|1.19|||Regression, Logistic||Change in all-cause 30-day mortality risk associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||1.19|0.68|0.45
70949490|NCT04148989|141400947|SUPERIORITY||Odds Ratio (OR)|0.83||||0.1|TWO_SIDED|95.0|0.67|1.04|||Regression, Logistic||Change in all-cause 1-year mortality risk associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||1.04|0.67|0.10
70949491|NCT04148989|141400948|SUPERIORITY||Odds Ratio (OR)|0.77||||0.15|TWO_SIDED|95.0|0.53|1.1|||Regression, Logistic|||Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.|Change in all-cause in-hospital mortality risk associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|1.10|0.53|0.15
70949492|NCT04148989|141400949|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.71|TWO_SIDED|95.0|-1.4|2.1|||Regression, gamma||Change in hospital charges ($1000s) associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable gamma regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||2.1|-1.4|0.71
70949493|NCT04148989|141400950|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.19|TWO_SIDED|95.0|-0.4|0.1|||Regression, gamma||Change in hospital length of stay (days) associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable gamma regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||0.1|-0.4|0.19
71141339|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|1.38||||0.5571|TWO_SIDED|95.0|0.47|4.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.04|0.47|0.5571
71141340|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|2.13||||0.1911|TWO_SIDED|95.0|0.69|6.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.59|0.69|0.1911
71141341|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|2.74||||0.1101|TWO_SIDED|95.0|0.8|9.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.41|0.80|0.1101
71141342|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|6.86||||0.0199|TWO_SIDED|95.0|1.36|34.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||34.74|1.36|0.0199
70866808|NCT02609828|141220093|SUPERIORITY||Difference in LS mean|-1.07|STANDARD_ERROR_OF_MEAN|0.54||0.0575|TWO_SIDED|95.0|-2.17|0.04|||ANCOVA|||Change at Week 1: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||0.04|-2.17|0.0575
70866809|NCT02609828|141220093|SUPERIORITY||Difference in LS mean|-1.96|STANDARD_ERROR_OF_MEAN|0.62||0.0031|TWO_SIDED|95.0|-3.22|-0.7|||ANCOVA|||Change at Week 2: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||-0.70|-3.22|0.0031
70866810|NCT02609828|141220093|SUPERIORITY||Difference in LS mean|-1.44|STANDARD_ERROR_OF_MEAN|0.68||0.041|TWO_SIDED|95.0|-2.82|-0.06|||ANCOVA|||Change at Week 4: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||-0.06|-2.82|0.0410
70866811|NCT02609828|141220093|SUPERIORITY||Difference in LS mean|-0.88|STANDARD_ERROR_OF_MEAN|0.77||0.2598|TWO_SIDED|95.0|-2.44|0.68|||ANCOVA|||Change at Week 6: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||0.68|-2.44|0.2598
70866812|NCT02609828|141220093|SUPERIORITY||Difference in LS mean|-0.77|STANDARD_ERROR_OF_MEAN|0.8||0.3426|TWO_SIDED|95.0|-2.38|0.85|||ANCOVA|||Change at Week 8: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||0.85|-2.38|0.3426
70866813|NCT02609828|141220093|SUPERIORITY||Difference in LS mean|-1.2|STANDARD_ERROR_OF_MEAN|0.72||0.1034|TWO_SIDED|95.0|-2.65|0.26|||ANCOVA|||Change at Week 12: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||0.26|-2.65|0.1034
70866814|NCT02609828|141220093|SUPERIORITY||Difference in LS mean|-1.91|STANDARD_ERROR_OF_MEAN|0.84||0.029|TWO_SIDED|95.0|-3.6|-0.21|||ANCOVA|||Change at Week 16: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||-0.21|-3.60|0.0290
70866815|NCT02609828|141220093|SUPERIORITY||Difference in LS mean|-1.62|STANDARD_ERROR_OF_MEAN|0.83||0.06|TWO_SIDED|95.0|-3.31|0.07|||ANCOVA|||Change at Week 24: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||0.07|-3.31|0.0600
70866816|NCT02609828|141220096|SUPERIORITY||Odds Ratio (OR)|1.14||||0.8054|TWO_SIDED|95.0|0.41|3.18|||Regression, Logistic|||Week 1 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.18|0.41|0.8054
70866817|NCT02609828|141220096|SUPERIORITY||Odds Ratio (OR)|0.94||||0.9292|TWO_SIDED|95.0|0.22|3.98|||Regression, Logistic|||Week 1 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.98|0.22|0.9292
70866818|NCT02609828|141220096|SUPERIORITY|||||||0.9565|||||||Regression, Logistic|||Week 1 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9565
70866819|NCT02609828|141220096|SUPERIORITY||Odds Ratio (OR)|1.88||||0.1429|TWO_SIDED|95.0|0.81|4.36|||Regression, Logistic|||Week 2 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.36|0.81|0.1429
70866820|NCT02609828|141220096|SUPERIORITY||Odds Ratio (OR)|5.19||||0.014||95.0|1.4|19.31|||Regression, Logistic|||Week 2 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||19.31|1.40|0.0140
70866821|NCT02609828|141220096|SUPERIORITY|||||||0.945|||||||Regression, Logistic|||Week 2 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9450
70866822|NCT02609828|141220096|SUPERIORITY|||||||0.9489|||||||Regression, Logistic|||Week 2 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9489
70866823|NCT02609828|141220096|SUPERIORITY||Odds Ratio (OR)|1.63||||0.1932|TWO_SIDED|95.0|0.78|3.39|||Regression, Logistic|||Week 4 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.39|0.78|0.1932
70949494|NCT04148989|141400951|SUPERIORITY|Multiple imputation was employed to account for missing covariate data affecting 3.6% of eligible patients.|Odds Ratio (OR)|1.1||||0.005|TWO_SIDED|95.0|1.03|1.17||Model adjusted for age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.|Regression, Logistic||Change in antimicrobial treatment risk associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis.|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for prespecified covariates.||1.17|1.03|0.005
70949495|NCT04148989|141400952|SUPERIORITY||Odds Ratio (OR)|1.09||||0.73|TWO_SIDED|95.0|0.68|1.75|||Regression, Logistic||Change in risk for possible antimicrobial-associated adverse event associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||1.75|0.68|0.73
70949496|NCT04148989|141400953|SUPERIORITY|Multiple imputation was employed to account for missing covariate data affecting 3.6% of eligible patients.|Odds Ratio (OR)|1.02||||0.9|TWO_SIDED|95.0|0.78|1.33||Model adjusted for age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.|Regression, Logistic|||Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for prespecified covariates.|Change in risk for possible antimicrobial-associated adverse event associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis.|1.33|0.78|0.90
70949497|NCT04148989|141400954|SUPERIORITY||Odds Ratio (OR)|1.03||||0.94|TWO_SIDED|95.0|0.49|2.17|||Regression, Logistic||Change in new-onset Clostridium difficile colitis risk associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis.|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||2.17|0.49|0.94
70949498|NCT04148989|141400955|SUPERIORITY|Multiple imputation was employed to account for missing covariate data affecting 3.6% of eligible patients.|Odds Ratio (OR)|1.41||||0.1|TWO_SIDED|95.0|0.93|2.14|||Regression, Logistic||Change in new-onset Clostridium difficile colitis risk associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis.|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for prespecified covariates.||2.14|0.93|0.10
70949499|NCT04148989|141400956|SUPERIORITY|Multiple imputation was employed to account for missing covariate data affecting 3.1% of eligible patients.|Odds Ratio (OR)|1.15||||0.59|TWO_SIDED|95.0|0.69|1.93|||Regression, Logistic||Change in risk for antimicrobial administration in the ED associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for prespecified covariates.||1.93|0.69|0.59
70949500|NCT04148989|141400957|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.02|TWO_SIDED|95.0|0.06|0.58|||Regression, Linear||Change in total spectrum score of antibiotics administered within 24 hours of ED arrival associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable ??? regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||0.58|0.06|0.02
70949501|NCT04148989|141400958|SUPERIORITY|Multiple imputation was employed to account for missing covariate data affecting 2.0% of eligible patients.|Mean Difference (Final Values)|0.17||||0.02|TWO_SIDED|95.0|0.03|0.31|||Regression, Linear||Change in total spectrum score of antibiotics administered within 24 hours of ED arrival associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable linear regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for prespecified covariates.||0.31|0.03|0.02
70949502|NCT03812029|141400959|SUPERIORITY|||||||0.0015||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.0015
70949503|NCT03812029|141400959|SUPERIORITY|||||||0.0121||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.0121
70949504|NCT03812029|141400959|SUPERIORITY|||||||0.0371||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.0371
70949505|NCT03812029|141400960|SUPERIORITY|||||||0.003||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.003
70949506|NCT03812029|141400960|SUPERIORITY|||||||0.04||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.04
70866824|NCT02609828|141220096|SUPERIORITY||Odds Ratio (OR)|3.17||||0.0254|TWO_SIDED|95.0|1.15|8.74|||Regression, Logistic|||Week 4 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||8.74|1.15|0.0254
70949507|NCT03812029|141400961|SUPERIORITY|||||||0.0017||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.0017
70949508|NCT03812029|141400961|SUPERIORITY|||||||0.018||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.018
70949509|NCT03812029|141400961|SUPERIORITY|||||||0.13||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.13
70949510|NCT03812029|141400962|SUPERIORITY|||||||0.001||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.001
70866825|NCT02609828|141220096|SUPERIORITY||Odds Ratio (OR)|5.0||||0.0455|TWO_SIDED|95.0|1.03|24.16|||Regression, Logistic|||Week 4 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||24.16|1.03|0.0455
70866826|NCT02609828|141220096|SUPERIORITY|||||||0.9464|||||||Regression, Logistic|||Week 4 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9464
70866827|NCT02609828|141220096|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0969|TWO_SIDED|95.0|0.9|3.72|||Regression, Logistic|||Week 6 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.72|0.90|0.0969
70866828|NCT02609828|141220096|SUPERIORITY||Odds Ratio (OR)|4.31||||0.0043|TWO_SIDED|95.0|1.58|11.74|||Regression, Logistic|||Week 6 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||11.74|1.58|0.0043
70866829|NCT02609828|141220096|SUPERIORITY||Odds Ratio (OR)|5.49||||0.0352|TWO_SIDED|95.0|1.13|26.75|||Regression, Logistic|||Week 6 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||26.75|1.13|0.0352
70866830|NCT02609828|141220096|SUPERIORITY|||||||0.9464|||||||Regression, Logistic|||Week 6 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9464
70949511|NCT03812029|141400962|SUPERIORITY|||||||0.002||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.002
70949512|NCT03812029|141400962|SUPERIORITY|||||||0.018||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.018
70949513|NCT03812029|141400963|SUPERIORITY|||||||0.09||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.09
70866831|NCT02609828|141220096|SUPERIORITY||Odds Ratio (OR)|1.71||||0.1471|TWO_SIDED|95.0|0.83|3.52|||Regression, Logistic|||Week 8 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.52|0.83|0.1471
70866832|NCT02609828|141220096|SUPERIORITY||Odds Ratio (OR)|2.55||||0.0405|TWO_SIDED|95.0|1.04|6.22|||Regression, Logistic|||Week 8 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||6.22|1.04|0.0405
70949514|NCT03812029|141400963|SUPERIORITY|||||||0.47||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.47
70949515|NCT03812029|141400963|SUPERIORITY|||||||0.14||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.14
70949516|NCT03812029|141400964|SUPERIORITY||||||<|0.0001||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||<0.0001
70949517|NCT03812029|141400964|SUPERIORITY||||||<|0.0001||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||<0.0001
70866833|NCT02609828|141220096|SUPERIORITY||Odds Ratio (OR)|3.21||||0.0993|TWO_SIDED|95.0|0.8|12.83|||Regression, Logistic|||Week 8 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||12.83|0.80|0.0993
70949518|NCT03812029|141400964|SUPERIORITY|||||||0.0002||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.0002
70949519|NCT03812029|141400965|SUPERIORITY|||||||0.017||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.017
70949520|NCT03812029|141400965|SUPERIORITY|||||||0.0006||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.0006
70949521|NCT03812029|141400965|SUPERIORITY|||||||0.006||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.006
70949522|NCT03812029|141400966|SUPERIORITY|||||||0.16||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.16
70949523|NCT03812029|141400966|SUPERIORITY|||||||0.01||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.01
70949524|NCT03812029|141400966|SUPERIORITY|||||||0.57||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.57
70949525|NCT03812029|141400967|SUPERIORITY|||||||0.0017||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.0017
70949526|NCT03812029|141400967|SUPERIORITY|||||||0.0093||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.0093
70949527|NCT00790205|141400978|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Hazard Ratio of Sitagliptin/Placebo: the between-treatment difference in time to the first primary composite CV outcome measure was assessed by the hazard ratio between the sitagliptin and placebo groups. The confidence interval for the hazard ratio was computed and compared to 1.30, the non-inferiority margin.|Hazard Ratio (HR)|0.98|||<|0.001|TWO_SIDED|95.0|0.88|1.09|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||1.09|0.88|<0.001
70866834|NCT02609828|141220096|SUPERIORITY||Odds Ratio (OR)|4.71||||0.1726|TWO_SIDED|95.0|0.51|43.64|||Regression, Logistic|||Week 8 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||43.64|0.51|0.1726
70949528|NCT00790205|141400979|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Hazard Ratio of Sitagliptin/Placebo: the between-treatment difference in time to the first primary composite CV outcome measure was assessed by the hazard ratio between the sitagliptin and placebo groups. The confidence interval for the hazard ratio was computed and compared to 1.30, the non-inferiority margin.|Hazard Ratio (HR)|0.98|||<|0.001|TWO_SIDED|95.0|0.89|1.08|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||1.08|0.89|<0.001
70949529|NCT00790205|141400980|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Hazard Ratio of Sitagliptin/Placebo: the between-treatment difference in time to the first primary composite CV outcome measure was assessed by the hazard ratio between the sitagliptin and placebo groups. The confidence interval for the hazard ratio was computed and compared to 1.30, the non-inferiority margin.|Hazard Ratio (HR)|0.99|||<|0.001|TWO_SIDED|95.0|0.89|1.11|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||1.11|0.89|<0.001
70949530|NCT00790205|141400981|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Hazard Ratio of Sitagliptin/Placebo: the between-treatment difference in time to the first primary composite CV outcome measure was assessed by the hazard ratio between the sitagliptin and placebo groups. The confidence interval for the hazard ratio was computed and compared to 1.30, the non-inferiority margin.|Hazard Ratio (HR)|0.99|||<|0.001|TWO_SIDED|95.0|0.89|1.1|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||1.10|0.89|<0.001
71141343|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|1.96||||0.26|TWO_SIDED|95.0|0.61|6.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.33|0.61|0.2600
71141344|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|8.93||||0.009|TWO_SIDED|95.0|1.73|46.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||46.19|1.73|0.0090
71141345|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|17.22||||0.0089|TWO_SIDED|95.0|2.04|145.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||145.2|2.04|0.0089
71141346|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8966|TWO_SIDED|95.0|0.36|3.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.19|0.36|0.8966
71141347|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|1.47||||0.5031|TWO_SIDED|95.0|0.48|4.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.51|0.48|0.5031
71141348|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|2.03||||0.2603|TWO_SIDED|95.0|0.59|6.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.92|0.59|0.2603
71141349|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|2.16||||0.2447|TWO_SIDED|95.0|0.59|7.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.88|0.59|0.2447
71141350|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|1.64||||0.4239|TWO_SIDED|95.0|0.49|5.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.55|0.49|0.4239
71141351|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|11.72||||0.024|TWO_SIDED|95.0|1.38|99.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||99.35|1.38|0.0240
71141352|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|2.6||||0.1457|TWO_SIDED|95.0|0.72|9.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||9.41|0.72|0.1457
71141353|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9|TWO_SIDED|95.0|0.34|3.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.38|0.34|0.9000
71141354|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|1.19||||0.7644|TWO_SIDED|95.0|0.39|3.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.64|0.39|0.7644
71141355|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|2.29||||0.2245|TWO_SIDED|95.0|0.6|8.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.67|0.60|0.2245
71141356|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0475|TWO_SIDED|95.0|1.02|27.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||27.40|1.02|0.0475
71141357|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|2.15||||0.2569|TWO_SIDED|95.0|0.57|8.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.07|0.57|0.2569
71141358|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|9.32||||0.0412|TWO_SIDED|95.0|1.09|79.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||79.44|1.09|0.0412
70949531|NCT00790205|141400982|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.06||||0.435|TWO_SIDED|95.0|0.91|1.24|||Cox proportional hazards model|||Hazard Ratio of Sitagliptin/Placebo: The between-treatment difference in mortality due to all causes was assessed by the hazard ratio between the Sitagliptin and Placebo groups.||1.24|0.91|0.435
70949532|NCT00790205|141400983|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.875|TWO_SIDED|95.0|0.9|1.14|||Cox proportional hazards model|||Hazard Ratio of Sitagliptin/Placebo: The between-treatment difference in mortality due to all causes was assessed by the hazard ratio between the Sitagliptin and Placebo groups.||1.14|0.90|0.875
70949533|NCT00790205|141400984|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98||||0.858|TWO_SIDED|95.0|0.81|1.19|||Cox proportional hazards model|Model stratified by region with treatment group and history of CHF at baseline as explanatory variables.||Hazard Ratio of Sitagliptin/Placebo: The between-treatment difference in CHF cases requiring hospitalization was assessed by the hazard ratio between the Sitagliptin and Placebo groups.||1.19|0.81|0.858
70949534|NCT00790205|141400985|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0||||0.983|TWO_SIDED|95.0|0.83|1.2|||Cox proportional hazards model|Model stratified by region with treatment group and history of CHF at baseline as explanatory variables.||Hazard Ratio of Sitagliptin/Placebo: The between-treatment difference in CHF cases requiring hospitalization was assessed by the hazard ratio between the Sitagliptin and Placebo groups.||1.20|0.83|0.983
70949535|NCT00790205|141400992|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69|||<|0.001|TWO_SIDED|95.0|0.61|0.77|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||0.77|0.61|<0.001
70949536|NCT00790205|141400993|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||<|0.001|TWO_SIDED|95.0|0.63|0.79|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||0.79|0.63|<0.001
70949537|NCT00790205|141400994|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||<|0.001|TWO_SIDED|95.0|0.65|0.75|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||0.75|0.65|<0.001
71141359|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|2.84||||0.1201|TWO_SIDED|95.0|0.76|10.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||10.61|0.76|0.1201
71141360|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|1.67||||0.3814|TWO_SIDED|95.0|0.53|5.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.23|0.53|0.3814
70949538|NCT00790205|141400995|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72|||<|0.001|TWO_SIDED|95.0|0.68|0.77|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||0.77|0.68|<0.001
70949539|NCT04937920|141400996|OTHER||Mean Paired Change from Baseline|-29620.0||||0.2|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The analysis compared the differences at Day 5 between DBI-002 probiotic gel (active) and vehicle gel (active Cohort 4 only) in abundance of Malassezia based on molecular diagnostic qPCR using a 2-sided Wilcoxon sign rank test, alpha = 0.05, with a null hypothesis of median difference equal to zero.||||0.2
70949540|NCT04937920|141400996|OTHER||Mean Paired Change from Baseline|127195.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The analysis compared the differences at Day 14 between DBI-002 probiotic gel (active) and vehicle gel (active Cohort 4 only) in abundance of Malassezia based on molecular diagnostic qPCR using a 2-sided Wilcoxon sign rank test, alpha = 0.05, with a null hypothesis of median difference equal to zero.||||1.0
70949541|NCT04937920|141400996|OTHER||Mean Paired Change from Baseline|-41659.0||||0.6|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The analysis compared the differences at Day 5 between aqueous gel (control) and vehicle gel (active Cohort 4 only) in abundance of Malassezia based on molecular diagnostic qPCR using a 2-sided Wilcoxon sign rank test, alpha = 0.05, with a null hypothesis of median difference equal to zero.||||0.6
71141361|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8549|TWO_SIDED|95.0|0.38|3.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.23|0.38|0.8549
71141362|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|2.77||||0.1274|TWO_SIDED|95.0|0.75|10.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.24|0.75|0.1274
71141363|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|3.67||||0.0703|TWO_SIDED|95.0|0.9|15.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||15.01|0.90|0.0703
71141364|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|2.41||||0.1821|TWO_SIDED|95.0|0.66|8.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.76|0.66|0.1821
71141365|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|12.96||||0.0187|TWO_SIDED|95.0|1.53|109.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||109.5|1.53|0.0187
71141366|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|4.18||||0.0458|TWO_SIDED|95.0|1.03|17.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||17.00|1.03|0.0458
71141367|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|1.27||||0.6806|TWO_SIDED|95.0|0.41|3.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.89|0.41|0.6806
71141368|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|1.15||||0.809|TWO_SIDED|95.0|0.38|3.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.45|0.38|0.8090
71141369|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|2.22||||0.2352|TWO_SIDED|95.0|0.6|8.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.26|0.60|0.2352
71141370|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|3.04||||0.1231|TWO_SIDED|95.0|0.74|12.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||12.50|0.74|0.1231
71141371|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|2.86||||0.1445|TWO_SIDED|95.0|0.7|11.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||11.76|0.70|0.1445
71141372|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|12.03||||0.023|TWO_SIDED|95.0|1.41|102.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||102.7|1.41|0.0230
71141373|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|3.51||||0.0801|TWO_SIDED|95.0|0.86|14.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||14.36|0.86|0.0801
71141374|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|1.63||||0.4152|TWO_SIDED|95.0|0.5|5.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.32|0.50|0.4152
71141375|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|1.7||||0.3845|TWO_SIDED|95.0|0.51|5.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.65|0.51|0.3845
70949542|NCT04937920|141400996|OTHER||Mean Paired Change from Baseline|-483.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The analysis compared the differences at Day 14 between aqueous gel (control) and vehicle gel (active Cohort 4 only) in abundance of Malassezia based on molecular diagnostic qPCR using a 2-sided Wilcoxon sign rank test, alpha = 0.05, with a null hypothesis of median difference equal to zero.||||1.0
70949543|NCT04092452|141401017|SUPERIORITY||Risk Difference (RD)|0.7|STANDARD_ERROR_OF_MEAN|9.69||0.4696|TWO_SIDED|90.0|-15.2|16.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||The null hypothesis for primary efficacy analysis was that the percentage of participants achieving HiSCR response at Week 16 was the same for the active treatment (PF-06650833, PF-06700841 or PF-06826647) and placebo. The treatment was considered superior to control if the difference was statistically significant at the overall 1-sided 0.1 level.||16.7|-15.2|0.4696
70949544|NCT04092452|141401017|SUPERIORITY||Risk Difference (RD)|18.7|STANDARD_ERROR_OF_MEAN|9.71||0.0298|TWO_SIDED|90.0|2.7|34.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||The null hypothesis for primary efficacy analysis was that the percentage of participants achieving HiSCR response at Week 16 was the same for the active treatment (PF-06650833, PF-06700841 or PF-06826647) and placebo. The treatment was considered superior to control if the difference was statistically significant at the overall 1-sided 0.1 level.||34.6|2.7|0.0298
70949545|NCT04092452|141401017|SUPERIORITY||Risk Difference (RD)|3.5|STANDARD_ERROR_OF_MEAN|9.79||0.3606|TWO_SIDED|90.0|-12.6|19.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||The null hypothesis for primary efficacy analysis was that the percentage of participants achieving HiSCR response at Week 16 was the same for the active treatment (PF-06650833, PF-06700841 or PF-06826647) and placebo. The treatment was considered superior to control if the difference was statistically significant at the overall 1-sided 0.1 level.||19.6|-12.6|0.3606
70949546|NCT04092452|141401018|SUPERIORITY||Risk Difference (RD)|-3.8|STANDARD_ERROR_OF_MEAN|7.19|||TWO_SIDED|90.0|-15.6|8.0||||||Week 1||8.0|-15.6|
70949547|NCT04092452|141401018|SUPERIORITY||Risk Difference (RD)|-0.9|STANDARD_ERROR_OF_MEAN|7.28|||TWO_SIDED|90.0|-12.9|11.1||||||Week 1||11.1|-12.9|
70949548|NCT04092452|141401018|SUPERIORITY||Risk Difference (RD)|4.6|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|90.0|-8.5|17.8||||||Week 1||17.8|-8.5|
70949549|NCT04092452|141401018|SUPERIORITY||Risk Difference (RD)|7.9|STANDARD_ERROR_OF_MEAN|9.02|||TWO_SIDED|90.0|-6.9|22.8||||||Week 2||22.8|-6.9|
70949550|NCT04092452|141401018|SUPERIORITY||Risk Difference (RD)|7.5|STANDARD_ERROR_OF_MEAN|8.91|||TWO_SIDED|90.0|-7.1|22.2||||||Week 2||22.2|-7.1|
71141376|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|2.46||||0.1864|TWO_SIDED|95.0|0.65|9.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||9.39|0.65|0.1864
70949551|NCT04092452|141401018|SUPERIORITY||Risk Difference (RD)|3.5|STANDARD_ERROR_OF_MEAN|9.0|||TWO_SIDED|90.0|-11.3|18.3||||||Week 2||18.3|-11.3|
70949552|NCT04092452|141401018|SUPERIORITY||Risk Difference (RD)|9.0|STANDARD_ERROR_OF_MEAN|9.79|||TWO_SIDED|90.0|-7.1|25.1||||||Week 4||25.1|-7.1|
70949553|NCT04092452|141401018|SUPERIORITY||Risk Difference (RD)|7.7|STANDARD_ERROR_OF_MEAN|9.57|||TWO_SIDED|90.0|-8.0|23.5||||||Week 4||23.5|-8.0|
70949554|NCT04092452|141401018|SUPERIORITY||Risk Difference (RD)|-4.0|STANDARD_ERROR_OF_MEAN|9.37|||TWO_SIDED|90.0|-19.4|11.4||||||Week 4||11.4|-19.4|
70949555|NCT04092452|141401018|SUPERIORITY||Risk Difference (RD)|0.8|STANDARD_ERROR_OF_MEAN|9.96|||TWO_SIDED|90.0|-15.6|17.2||||||Week 6||17.2|-15.6|
70949556|NCT04092452|141401018|SUPERIORITY||Risk Difference (RD)|6.7|STANDARD_ERROR_OF_MEAN|9.81|||TWO_SIDED|90.0|-9.4|22.9||||||Week 6||22.9|-9.4|
70949557|NCT04092452|141401018|SUPERIORITY||Risk Difference (RD)|3.7|STANDARD_ERROR_OF_MEAN|10.05|||TWO_SIDED|90.0|-12.8|20.2||||||Week 6||20.2|-12.8|
70949558|NCT04092452|141401018|SUPERIORITY||Risk Difference (RD)|-7.8|STANDARD_ERROR_OF_MEAN|9.98||0.7798|TWO_SIDED|90.0|-24.2|8.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||8.7|-24.2|0.7798
70949559|NCT04092452|141401018|SUPERIORITY||Risk Difference (RD)|0.5|STANDARD_ERROR_OF_MEAN|9.92||0.4819|TWO_SIDED|90.0|-15.9|16.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||16.8|-15.9|0.4819
70949560|NCT04092452|141401018|SUPERIORITY||Risk Difference (RD)|-2.4|STANDARD_ERROR_OF_MEAN|10.19||0.5933|TWO_SIDED|90.0|-19.2|14.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||14.4|-19.2|0.5933
70949561|NCT04092452|141401018|SUPERIORITY||Risk Difference (RD)|-9.9|STANDARD_ERROR_OF_MEAN|9.81||0.8421|TWO_SIDED|90.0|-26.1|6.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||6.2|-26.1|0.8421
70949562|NCT04092452|141401018|SUPERIORITY||Risk Difference (RD)|8.0|STANDARD_ERROR_OF_MEAN|9.85||0.209|TWO_SIDED|90.0|-8.2|24.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||24.2|-8.2|0.2090
70949563|NCT04092452|141401018|SUPERIORITY||Risk Difference (RD)|-0.5|STANDARD_ERROR_OF_MEAN|10.12||0.5183|TWO_SIDED|90.0|-17.1|16.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||16.2|-17.1|0.5183
70949564|NCT04092452|141401019|SUPERIORITY||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|7.54||0.515|TWO_SIDED|90.0|-12.7|12.1||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Total AN Count of 0 or 1||12.1|-12.7|0.5150
71141377|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|3.06||||0.01268|TWO_SIDED|95.0|0.73|12.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||12.86|0.73|0.01268
70949565|NCT04092452|141401019|SUPERIORITY||Risk Difference (RD)|12.2|STANDARD_ERROR_OF_MEAN|8.28||0.0737|TWO_SIDED|90.0|-1.4|25.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Total AN Count of 0 or 1||25.8|-1.4|0.0737
70949566|NCT04092452|141401019|SUPERIORITY||Risk Difference (RD)|6.6|STANDARD_ERROR_OF_MEAN|8.11||0.2081|TWO_SIDED|90.0|-6.7|20.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Total AN Count of 0 or 1||20.0|-6.7|0.2081
70949567|NCT04092452|141401019|SUPERIORITY||Risk Difference (RD)|4.8|STANDARD_ERROR_OF_MEAN|8.9||0.2957|TWO_SIDED|90.0|-9.9|19.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Total AN Count of 0, 1 or 2||19.4|-9.9|0.2957
70949568|NCT04092452|141401019|SUPERIORITY||Risk Difference (RD)|15.6|STANDARD_ERROR_OF_MEAN|9.07||0.0456|TWO_SIDED|90.0|0.7|30.5||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Total AN Count of 0, 1 or 2||30.5|0.7|0.0456
70949569|NCT04092452|141401019|SUPERIORITY||Risk Difference (RD)|9.2|STANDARD_ERROR_OF_MEAN|9.05||0.1558|TWO_SIDED|90.0|-5.7|24.1||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Total AN Count of 0, 1 or 2||24.1|-5.7|0.1558
70949570|NCT04092452|141401020|SUPERIORITY||Risk Difference (RD)|-11.98|STANDARD_ERROR_OF_MEAN|8.622|||TWO_SIDED|90.0|-26.16|2.2||||||Week 1||2.20|-26.16|
70949571|NCT04092452|141401020|SUPERIORITY||Risk Difference (RD)|-15.07|STANDARD_ERROR_OF_MEAN|8.526|||TWO_SIDED|90.0|-29.09|-1.04||||||Week 1||-1.04|-29.09|
70949572|NCT04092452|141401020|SUPERIORITY||Risk Difference (RD)|-17.45|STANDARD_ERROR_OF_MEAN|8.758|||TWO_SIDED|90.0|-31.86|-3.05||||||Week 1||-3.05|-31.86|
70949573|NCT04092452|141401020|SUPERIORITY||Risk Difference (RD)|-12.52|STANDARD_ERROR_OF_MEAN|9.465|||TWO_SIDED|90.0|-28.09|3.05||||||Week 2||3.05|-28.09|
70949574|NCT04092452|141401020|SUPERIORITY||Risk Difference (RD)|-2.86|STANDARD_ERROR_OF_MEAN|9.338|||TWO_SIDED|90.0|-18.22|12.5||||||Week 2||12.50|-18.22|
70949575|NCT04092452|141401020|SUPERIORITY||Risk Difference (RD)|-5.5|STANDARD_ERROR_OF_MEAN|9.438|||TWO_SIDED|90.0|-21.02|10.03||||||Week 2||10.03|-21.02|
70949576|NCT04092452|141401020|SUPERIORITY||Risk Difference (RD)|-4.52|STANDARD_ERROR_OF_MEAN|11.214|||TWO_SIDED|90.0|-22.96|13.93||||||Week 4||13.93|-22.96|
70949577|NCT04092452|141401020|SUPERIORITY||Risk Difference (RD)|-17.54|STANDARD_ERROR_OF_MEAN|11.131|||TWO_SIDED|90.0|-35.84|0.77||||||Week 4||0.77|-35.84|
70949578|NCT04092452|141401020|SUPERIORITY||Risk Difference (RD)|-3.92|STANDARD_ERROR_OF_MEAN|11.507|||TWO_SIDED|90.0|-22.85|15.0||||||Week 4||15.00|-22.85|
70949579|NCT04092452|141401020|SUPERIORITY||Risk Difference (RD)|7.09|STANDARD_ERROR_OF_MEAN|13.452|||TWO_SIDED|90.0|-15.04|29.22||||||Week 6||29.22|-15.04|
70949580|NCT04092452|141401020|SUPERIORITY||Risk Difference (RD)|-14.57|STANDARD_ERROR_OF_MEAN|13.688|||TWO_SIDED|90.0|-37.08|7.95||||||Week 6||7.95|-37.08|
70949581|NCT04092452|141401020|SUPERIORITY||Risk Difference (RD)|-8.95|STANDARD_ERROR_OF_MEAN|13.808|||TWO_SIDED|90.0|-31.66|13.76||||||Week 6||13.76|-31.66|
70949582|NCT04092452|141401020|SUPERIORITY||Risk Difference (RD)|11.5|STANDARD_ERROR_OF_MEAN|13.057||0.8108|TWO_SIDED|90.0|-9.98|32.98||One-sided p-value|ANCOVA|||Week 8||32.98|-9.98|0.8108
70949583|NCT04092452|141401020|SUPERIORITY||Risk Difference (RD)|-16.15|STANDARD_ERROR_OF_MEAN|12.845||0.1043|TWO_SIDED|90.0|-37.28|4.98||One-sided p-value|ANCOVA|||Week 8||4.98|-37.28|0.1043
70949584|NCT04092452|141401020|SUPERIORITY||Risk Difference (RD)|-15.07|STANDARD_ERROR_OF_MEAN|13.355||0.1296|TWO_SIDED|90.0|-37.04|6.9||One-sided p-value|ANCOVA|||Week 8||6.90|-37.04|0.1296
70949585|NCT04092452|141401020|SUPERIORITY||Risk Difference (RD)|-6.54|STANDARD_ERROR_OF_MEAN|16.384||0.345|TWO_SIDED|90.0|-33.49|20.42||One-sided p-value|ANCOVA|||Week 12||20.42|-33.49|0.3450
70949586|NCT04092452|141401020|SUPERIORITY||Risk Difference (RD)|-17.18|STANDARD_ERROR_OF_MEAN|14.116||0.1119|TWO_SIDED|90.0|-40.4|6.04||One-sided p-value|ANCOVA|||Week 12||6.04|-40.40|0.1119
70949587|NCT04092452|141401020|SUPERIORITY||Risk Difference (RD)|-19.99|STANDARD_ERROR_OF_MEAN|14.806||0.0885|TWO_SIDED|90.0|-44.34|4.37||One-sided p-value|ANCOVA|||Week 12||4.37|-44.34|0.0885
70949588|NCT04092452|141401020|SUPERIORITY||Risk Difference (RD)|10.85|STANDARD_ERROR_OF_MEAN|20.14||0.705|TWO_SIDED|90.0|-22.28|43.98||One-sided p-value|ANCOVA|||Week 16||43.98|-22.28|0.7050
70949589|NCT04092452|141401020|SUPERIORITY||Risk Difference (RD)|-17.62|STANDARD_ERROR_OF_MEAN|19.519||0.1833|TWO_SIDED|90.0|-49.73|14.48||One-sided p-value|ANCOVA|||Week 16||14.48|-49.73|0.1833
70949590|NCT04092452|141401020|SUPERIORITY||Risk Difference (RD)|-9.41|STANDARD_ERROR_OF_MEAN|20.277||0.3213|TWO_SIDED|90.0|-42.76|23.94||One-sided p-value|ANCOVA|||Week 16||23.94|-42.76|0.3213
70949591|NCT04092452|141401021|SUPERIORITY||Risk Difference (RD)|-1.5|STANDARD_ERROR_OF_MEAN|2.67|||TWO_SIDED|90.0|-5.9|2.9||||||Week 1 - Statistical Analysis (MI) - Absolute Score||2.9|-5.9|
70949592|NCT04092452|141401021|SUPERIORITY||Risk Difference (RD)|-2.0|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|90.0|-6.3|2.2||||||Week 1 - Statistical Analysis (MI) - Absolute Score||2.2|-6.3|
70949593|NCT04092452|141401021|SUPERIORITY||Risk Difference (RD)|-1.5|STANDARD_ERROR_OF_MEAN|2.68|||TWO_SIDED|90.0|-5.9|2.9||||||Week 1 - Statistical Analysis (MI) - Absolute Score||2.9|-5.9|
70949594|NCT04092452|141401021|SUPERIORITY||Risk Difference (RD)|-0.9|STANDARD_ERROR_OF_MEAN|2.59|||TWO_SIDED|90.0|-5.2|3.3||||||Week 2 - Statistical Analysis (MI) - Absolute Score||3.3|-5.2|
70949595|NCT04092452|141401021|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|2.55|||TWO_SIDED|90.0|-4.3|4.1||||||Week 2 - Statistical Analysis (MI) - Absolute Score||4.1|-4.3|
70949596|NCT04092452|141401021|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|2.61|||TWO_SIDED|90.0|-4.3|4.3||||||Week 2 - Statistical Analysis (MI) - Absolute Score||4.3|-4.3|
70949597|NCT04092452|141401021|SUPERIORITY||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|2.51|||TWO_SIDED|90.0|-4.5|3.8||||||Week 4 - Statistical Analysis (MI) - Absolute Score||3.8|-4.5|
70949598|NCT04092452|141401021|SUPERIORITY||Risk Difference (RD)|-1.3|STANDARD_ERROR_OF_MEAN|2.48|||TWO_SIDED|90.0|-5.4|2.8||||||Week 4 - Statistical Analysis (MI) - Absolute Score||2.8|-5.4|
70949599|NCT04092452|141401021|SUPERIORITY||Risk Difference (RD)|-4.5|STANDARD_ERROR_OF_MEAN|2.58|||TWO_SIDED|90.0|-8.8|-0.3||||||Week 4 - Statistical Analysis (MI) - Absolute Score||-0.3|-8.8|
70949600|NCT04092452|141401021|SUPERIORITY||Risk Difference (RD)|-1.6|STANDARD_ERROR_OF_MEAN|2.99|||TWO_SIDED|90.0|-6.5|3.3||||||Week 6 - Statistical Analysis (MI) - Absolute Score||3.3|-6.5|
70949601|NCT04092452|141401021|SUPERIORITY||Risk Difference (RD)|-4.7|STANDARD_ERROR_OF_MEAN|2.91|||TWO_SIDED|90.0|-9.5|0.1||||||Week 6 - Statistical Analysis (MI) - Absolute Score||0.1|-9.5|
70949602|NCT04092452|141401021|SUPERIORITY||Risk Difference (RD)|-5.4|STANDARD_ERROR_OF_MEAN|3.08|||TWO_SIDED|90.0|-10.5|-0.4||||||Week 6 - Statistical Analysis (MI) - Absolute Score||-0.4|-10.5|
70949603|NCT04092452|141401021|SUPERIORITY||Risk Difference (RD)|1.0|STANDARD_ERROR_OF_MEAN|2.78||0.6393|TWO_SIDED|90.0|-3.6|5.6||One-sided p-value|ANCOVA|||Week 8 - Statistical Analysis (MI) - Absolute Score||5.6|-3.6|0.6393
70949604|NCT04092452|141401021|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|2.72||0.5178|TWO_SIDED|90.0|-4.4|4.6||One-sided p-value|ANCOVA|||Week 8 - Statistical Analysis (MI) - Absolute Score||4.6|-4.4|0.5178
70949605|NCT04092452|141401021|SUPERIORITY||Risk Difference (RD)|-3.8|STANDARD_ERROR_OF_MEAN|2.82||0.0864|TWO_SIDED|90.0|-8.5|0.8||One-sided p-value|ANCOVA|||Week 8 - Statistical Analysis (MI) - Absolute Score||0.8|-8.5|0.0864
70949606|NCT04092452|141401021|SUPERIORITY||Risk Difference (RD)|-1.2|STANDARD_ERROR_OF_MEAN|2.61||0.3172|TWO_SIDED|90.0|-5.5|3.1||One-sided p-value|ANCOVA|||Week 12 - Statistical Analysis (MI) - Absolute Score||3.1|-5.5|0.3172
70949607|NCT04092452|141401021|SUPERIORITY||Risk Difference (RD)|-2.7|STANDARD_ERROR_OF_MEAN|2.51||0.1384|TWO_SIDED|90.0|-6.8|1.4||One-sided p-value|ANCOVA|||Week 12 - Statistical Analysis (MI) - Absolute Score||1.4|-6.8|0.1384
70949608|NCT04092452|141401021|SUPERIORITY||Risk Difference (RD)|-2.8|STANDARD_ERROR_OF_MEAN|2.66||0.1427|TWO_SIDED|90.0|-7.2|1.5||One-sided p-value|ANCOVA|||Week 12 - Statistical Analysis (MI) - Absolute Score||1.5|-7.2|0.1427
70949609|NCT04092452|141401021|SUPERIORITY||Risk Difference (RD)|-2.5|STANDARD_ERROR_OF_MEAN|2.99||0.1975|TWO_SIDED|90.0|-7.5|2.4||One-sided p-value|ANCOVA|||Week 16 - Statistical Analysis (MI) - Absolute Score||2.4|-7.5|0.1975
71141378|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|2.8||||0.16|TWO_SIDED|95.0|0.67|11.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||11.76|0.67|0.1600
70949610|NCT04092452|141401021|SUPERIORITY||Risk Difference (RD)|-4.0|STANDARD_ERROR_OF_MEAN|2.76||0.0755|TWO_SIDED|90.0|-8.5|0.6||One-sided p-value|ANCOVA|||Week 16 - Statistical Analysis (MI) - Absolute Score||0.6|-8.5|0.0755
70949611|NCT04092452|141401021|SUPERIORITY||Risk Difference (RD)|-2.6|STANDARD_ERROR_OF_MEAN|2.89||0.1869|TWO_SIDED|90.0|-7.3|2.2||One-sided p-value|ANCOVA|||Week 16 - Statistical Analysis (MI) - Absolute Score||2.2|-7.3|0.1869
70949612|NCT04092452|141401022|SUPERIORITY||Risk Difference (RD)|-3.65|STANDARD_ERROR_OF_MEAN|8.659|||TWO_SIDED|90.0|-17.9|10.59||||||Week 1 - Statistical Analysis (MI) - Percent Change from Baseline||10.59|-17.90|
70949613|NCT04092452|141401022|SUPERIORITY||Risk Difference (RD)|-13.77|STANDARD_ERROR_OF_MEAN|8.749|||TWO_SIDED|90.0|-28.16|0.62||||||Week 1 - Statistical Analysis (MI) - Percent Change from Baseline||0.62|-28.16|
70949614|NCT04092452|141401022|SUPERIORITY||Risk Difference (RD)|-17.51|STANDARD_ERROR_OF_MEAN|8.752|||TWO_SIDED|90.0|-31.91|-3.12||||||Week 1 - Statistical Analysis (MI) - Percent Change from Baseline||-3.12|-31.91|
70949615|NCT04092452|141401022|SUPERIORITY||Risk Difference (RD)|-4.29|STANDARD_ERROR_OF_MEAN|10.103|||TWO_SIDED|90.0|-20.91|12.33||||||Week 2 - Statistical Analysis (MI) - Percent Change from Baseline||12.33|-20.91|
70949616|NCT04092452|141401022|SUPERIORITY||Risk Difference (RD)|-2.05|STANDARD_ERROR_OF_MEAN|9.904|||TWO_SIDED|90.0|-18.34|14.24||||||Week 2 - Statistical Analysis (MI) - Percent Change from Baseline||14.24|-18.34|
70949617|NCT04092452|141401022|SUPERIORITY||Risk Difference (RD)|0.17|STANDARD_ERROR_OF_MEAN|10.039|||TWO_SIDED|90.0|-16.34|16.68||||||Week 2 - Statistical Analysis (MI) - Percent Change from Baseline||16.68|-16.34|
70949618|NCT04092452|141401022|SUPERIORITY||Risk Difference (RD)|-0.46|STANDARD_ERROR_OF_MEAN|10.227|||TWO_SIDED|90.0|-17.29|16.36||||||Week 4 - Statistical Analysis (MI) - Percent Change from Baseline||16.36|-17.29|
70949619|NCT04092452|141401022|SUPERIORITY||Risk Difference (RD)|-8.07|STANDARD_ERROR_OF_MEAN|10.155|||TWO_SIDED|90.0|-24.77|8.63||||||Week 4 - Statistical Analysis (MI) - Percent Change from Baseline||8.63|-24.77|
70949620|NCT04092452|141401022|SUPERIORITY||Risk Difference (RD)|-6.06|STANDARD_ERROR_OF_MEAN|10.509|||TWO_SIDED|90.0|-23.35|11.22||||||Week 4 - Statistical Analysis (MI) - Percent Change from Baseline||11.22|-23.35|
70949621|NCT04092452|141401022|SUPERIORITY||Risk Difference (RD)|-3.54|STANDARD_ERROR_OF_MEAN|12.262|||TWO_SIDED|90.0|-23.71|16.63||||||Week 6 - Statistical Analysis (MI) - Percent Change from Baseline||16.63|-23.71|
70949622|NCT04092452|141401022|SUPERIORITY||Risk Difference (RD)|-16.26|STANDARD_ERROR_OF_MEAN|12.51|||TWO_SIDED|90.0|-36.84|4.32||||||Week 6 - Statistical Analysis (MI) - Percent Change from Baseline||4.32|-36.84|
70949623|NCT04092452|141401022|SUPERIORITY||Risk Difference (RD)|-12.52|STANDARD_ERROR_OF_MEAN|12.61|||TWO_SIDED|90.0|-33.27|8.22||||||Week 6 - Statistical Analysis (MI) - Percent Change from Baseline||8.22|-33.27|
70949624|NCT04092452|141401022|SUPERIORITY||Risk Difference (RD)|5.79|STANDARD_ERROR_OF_MEAN|11.045||0.7|TWO_SIDED|90.0|-12.38|23.96||One-sided p-value|ANCOVA|||Week 8 - Statistical Analysis (MI) - Percent Change from Baseline||23.96|-12.38|0.7000
70949625|NCT04092452|141401022|SUPERIORITY||Risk Difference (RD)|-5.81|STANDARD_ERROR_OF_MEAN|10.876||0.2965|TWO_SIDED|90.0|-23.7|12.08||One-sided p-value|ANCOVA|||Week 8 - Statistical Analysis (MI) - Percent Change from Baseline||12.08|-23.70|0.2965
71141379|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|6.13||||0.0317|TWO_SIDED|95.0|1.17|32.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||32.11|1.17|0.0317
71141380|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|3.73||||0.0709|TWO_SIDED|95.0|0.89|15.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||15.53|0.89|0.0709
70949626|NCT04092452|141401022|SUPERIORITY||Risk Difference (RD)|-11.33|STANDARD_ERROR_OF_MEAN|11.247||0.1568|TWO_SIDED|90.0|-29.83|7.17||One-sided p-value|ANCOVA|||Week 8 - Statistical Analysis (MI) - Percent Change from Baseline||7.17|-29.83|0.1568
70949627|NCT04092452|141401022|SUPERIORITY||Risk Difference (RD)|-6.78|STANDARD_ERROR_OF_MEAN|10.912||0.2672|TWO_SIDED|90.0|-24.73|11.17||One-sided p-value|ANCOVA|||Week 12 - Statistical Analysis (MI) - Percent Change from Baseline||11.17|-24.73|0.2672
70949628|NCT04092452|141401022|SUPERIORITY||Risk Difference (RD)|-16.57|STANDARD_ERROR_OF_MEAN|10.517||0.0576|TWO_SIDED|90.0|-33.87|0.73||One-sided p-value|ANCOVA|||Week 12 - Statistical Analysis (MI) - Percent Change from Baseline||0.73|-33.87|0.0576
70949629|NCT04092452|141401022|SUPERIORITY||Risk Difference (RD)|-13.65|STANDARD_ERROR_OF_MEAN|11.603||0.1197|TWO_SIDED|90.0|-32.74|5.44||One-sided p-value|ANCOVA|||Week 12 - Statistical Analysis (MI) - Percent Change from Baseline||5.44|-32.74|0.1197
70949630|NCT04092452|141401022|SUPERIORITY||Risk Difference (RD)|-5.63|STANDARD_ERROR_OF_MEAN|13.545||0.3388|TWO_SIDED|90.0|-27.91|16.65||One-sided p-value|ANCOVA|||Week 16 - Statistical Analysis (MI) - Percent Change from Baseline||16.65|-27.91|0.3388
70949631|NCT04092452|141401022|SUPERIORITY||Risk Difference (RD)|-14.8|STANDARD_ERROR_OF_MEAN|13.567||0.1376|TWO_SIDED|90.0|-37.12|7.51||One-sided p-value|ANCOVA|||Week 16 - Statistical Analysis (MI) - Percent Change from Baseline||7.51|-37.12|0.1376
70949632|NCT04092452|141401022|SUPERIORITY||Risk Difference (RD)|-8.32|STANDARD_ERROR_OF_MEAN|13.86||0.2741|TWO_SIDED|90.0|-31.12|14.48||One-sided p-value|ANCOVA|||Week 16||14.48|-31.12|0.2741
70949633|NCT04092452|141401023|SUPERIORITY||Risk Difference (RD)|-1.3|STANDARD_ERROR_OF_MEAN|7.06|||TWO_SIDED|90.0|-13.0|10.3||||||Week 4||10.3|-13.0|
70949634|NCT04092452|141401023|SUPERIORITY||Risk Difference (RD)|-8.5|STANDARD_ERROR_OF_MEAN|6.23|||TWO_SIDED|90.0|-18.7|1.8||||||Week 4||1.8|-18.7|
71141381|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|1.6||||0.4533|TWO_SIDED|95.0|0.47|5.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.41|0.47|0.4533
70949635|NCT04092452|141401023|SUPERIORITY||Risk Difference (RD)|1.7|STANDARD_ERROR_OF_MEAN|7.55|||TWO_SIDED|90.0|-10.7|14.1||||||Week 4||14.1|-10.7|
70949636|NCT04092452|141401023|SUPERIORITY||Risk Difference (RD)|6.6|STANDARD_ERROR_OF_MEAN|6.8||0.8372|TWO_SIDED|90.0|-4.6|17.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||17.7|-4.6|0.8372
70949637|NCT04092452|141401023|SUPERIORITY||Risk Difference (RD)|-6.4|STANDARD_ERROR_OF_MEAN|4.68||0.0819|TWO_SIDED|90.0|-14.1|1.3||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||1.3|-14.1|0.0819
70949638|NCT04092452|141401023|SUPERIORITY||Risk Difference (RD)|-8.0|STANDARD_ERROR_OF_MEAN|4.34||0.0242|TWO_SIDED|90.0|-15.2|-0.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||-0.9|-15.2|0.0242
70949639|NCT04092452|141401023|SUPERIORITY||Risk Difference (RD)|-12.7|STANDARD_ERROR_OF_MEAN|6.33||0.0264|TWO_SIDED|90.0|-23.1|-2.3||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||-2.3|-23.1|0.0264
70949640|NCT04092452|141401023|SUPERIORITY||Risk Difference (RD)|-14.5|STANDARD_ERROR_OF_MEAN|6.47||0.0127|TWO_SIDED|90.0|-25.1|-3.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||-3.9|-25.1|0.0127
70949641|NCT04092452|141401023|SUPERIORITY||Risk Difference (RD)|-16.6|STANDARD_ERROR_OF_MEAN|6.33||0.0059|TWO_SIDED|90.0|-27.0|-6.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||-6.2|-27.0|0.0059
70949642|NCT04092452|141401023|SUPERIORITY||Risk Difference (RD)|-9.6|STANDARD_ERROR_OF_MEAN|7.97||0.1185|TWO_SIDED|90.0|-22.7|3.5||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16||3.5|-22.7|0.1185
70949643|NCT04092452|141401023|SUPERIORITY||Risk Difference (RD)|-16.1|STANDARD_ERROR_OF_MEAN|6.39||0.004|TWO_SIDED|90.0|-26.6|-5.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16||-5.6|-26.6|0.0040
71141382|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|0.8||||0.7053|TWO_SIDED|95.0|0.24|2.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||2.60|0.24|0.7053
70949644|NCT04092452|141401023|SUPERIORITY||Risk Difference (RD)|-12.8|STANDARD_ERROR_OF_MEAN|7.09||0.0418|TWO_SIDED|90.0|-24.5|-1.1||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16||-1.1|-24.5|0.0418
70949645|NCT04092452|141401024|SUPERIORITY||Risk Difference (RD)|12.1|STANDARD_ERROR_OF_MEAN|7.75||0.0559|TWO_SIDED|90.0|-0.7|24.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 1 (Pain at its Worst)||24.8|-0.7|0.0559
70949646|NCT04092452|141401024|SUPERIORITY||Risk Difference (RD)|9.8|STANDARD_ERROR_OF_MEAN|7.09||0.0758|TWO_SIDED|90.0|-1.9|21.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 1 (Pain at its Worst)||21.4|-1.9|0.0758
70949647|NCT04092452|141401024|SUPERIORITY||Risk Difference (RD)|11.3|STANDARD_ERROR_OF_MEAN|7.21||0.0637|TWO_SIDED|90.0|-0.6|23.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 1 (Pain at its Worst)||23.2|-0.6|0.0637
70949648|NCT04092452|141401024|SUPERIORITY||Risk Difference (RD)|4.2|STANDARD_ERROR_OF_MEAN|8.84||0.3179|TWO_SIDED|90.0|-10.3|18.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 2 (Pain at its Worst)||18.8|-10.3|0.3179
70949649|NCT04092452|141401024|SUPERIORITY||Risk Difference (RD)|11.0|STANDARD_ERROR_OF_MEAN|8.82||0.1078|TWO_SIDED|90.0|-3.5|25.5||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 2 (Pain at its Worst)||25.5|-3.5|0.1078
70949650|NCT04092452|141401024|SUPERIORITY||Risk Difference (RD)|7.6|STANDARD_ERROR_OF_MEAN|8.86||0.1976|TWO_SIDED|90.0|-7.0|22.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 2 (Pain at its Worst)||22.2|-7.0|0.1976
70949651|NCT04092452|141401024|SUPERIORITY||Risk Difference (RD)|-18.9|STANDARD_ERROR_OF_MEAN|9.32||0.9738|TWO_SIDED|90.0|-34.3|-3.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 4 (Pain at its Worst)||-3.6|-34.3|0.9738
70949652|NCT04092452|141401024|SUPERIORITY||Risk Difference (RD)|5.8|STANDARD_ERROR_OF_MEAN|10.4||0.2925|TWO_SIDED|90.0|-11.3|22.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 4 (Pain at its Worst)||22.9|-11.3|0.2925
70949653|NCT04092452|141401024|SUPERIORITY||Risk Difference (RD)|-3.1|STANDARD_ERROR_OF_MEAN|10.18||0.6178|TWO_SIDED|90.0|-19.8|13.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 4 (Pain at its Worst)||13.7|-19.8|0.6178
70949654|NCT04092452|141401024|SUPERIORITY||Risk Difference (RD)|-20.9|STANDARD_ERROR_OF_MEAN|10.04||0.9769|TWO_SIDED|90.0|-37.4|-4.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 6 (Pain at its Worst)||-4.4|-37.4|0.9769
70949655|NCT04092452|141401024|SUPERIORITY||Risk Difference (RD)|-4.2|STANDARD_ERROR_OF_MEAN|10.57||0.6529|TWO_SIDED|90.0|-21.6|13.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 6 (Pain at its Worst)||13.2|-21.6|0.6529
70949656|NCT04092452|141401024|SUPERIORITY||Risk Difference (RD)|-12.8|STANDARD_ERROR_OF_MEAN|10.36||0.8878|TWO_SIDED|90.0|-29.8|4.3||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 6 (Pain at its Worst)||4.3|-29.8|0.8878
70949657|NCT04092452|141401024|SUPERIORITY||Risk Difference (RD)|-6.2|STANDARD_ERROR_OF_MEAN|10.11||0.7259|TWO_SIDED|90.0|-22.9|10.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8 (Pain at its Worst)||10.4|-22.9|0.7259
70949658|NCT04092452|141401024|SUPERIORITY||Risk Difference (RD)|14.8|STANDARD_ERROR_OF_MEAN|10.24||0.0826|TWO_SIDED|90.0|-2.1|31.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8 (Pain at its Worst)||31.6|-2.1|0.0826
70949659|NCT04092452|141401024|SUPERIORITY||Risk Difference (RD)|-8.0|STANDARD_ERROR_OF_MEAN|9.75||0.7884|TWO_SIDED|90.0|-24.1|8.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8 (Pain at its Worst)||8.0|-24.1|0.7884
70949660|NCT04092452|141401024|SUPERIORITY||Risk Difference (RD)|-16.1|STANDARD_ERROR_OF_MEAN|10.43||0.9326|TWO_SIDED|90.0|-33.2|1.1||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12 (Pain at its Worst)||1.1|-33.2|0.9326
71141383|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|1.84||||0.3677|TWO_SIDED|95.0|0.49|6.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.99|0.49|0.3677
70949661|NCT04092452|141401024|SUPERIORITY||Risk Difference (RD)|-4.9|STANDARD_ERROR_OF_MEAN|10.41||0.681|TWO_SIDED|90.0|-22.1|12.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12 (Pain at its Worst)||12.2|-22.1|0.6810
70949662|NCT04092452|141401024|SUPERIORITY||Risk Difference (RD)|-10.3|STANDARD_ERROR_OF_MEAN|10.52||0.8308|TWO_SIDED|90.0|-27.6|7.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12 (Pain at its Worst)||7.0|-27.6|0.8308
70949663|NCT04092452|141401024|SUPERIORITY||Risk Difference (RD)|-8.5|STANDARD_ERROR_OF_MEAN|9.71||0.8063|TWO_SIDED|90.0|-24.5|7.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16 (Pain at its Worst)||7.4|-24.5|0.8063
70949664|NCT04092452|141401024|SUPERIORITY||Risk Difference (RD)|6.5|STANDARD_ERROR_OF_MEAN|10.27||0.2649|TWO_SIDED|90.0|-10.4|23.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16 (Pain at its Worst)||23.4|-10.4|0.2649
70949665|NCT04092452|141401024|SUPERIORITY||Risk Difference (RD)|5.3|STANDARD_ERROR_OF_MEAN|10.35||0.3029|TWO_SIDED|90.0|-11.7|22.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16 (Pain at its Worst)||22.4|-11.7|0.3029
71141384|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|1.24||||0.735|TWO_SIDED|95.0|0.35|4.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||4.40|0.35|0.7350
70949666|NCT04092452|141401025|SUPERIORITY||Risk Difference (RD)|7.7|STANDARD_ERROR_OF_MEAN|8.2||0.1687|TWO_SIDED|90.0|-5.7|21.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 1 (Average Pain)||21.2|-5.7|0.1687
70949667|NCT04092452|141401025|SUPERIORITY||Risk Difference (RD)|13.8|STANDARD_ERROR_OF_MEAN|8.03||0.0376|TWO_SIDED|90.0|0.6|27.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 1 (Average Pain)||27.0|0.6|0.0376
70949668|NCT04092452|141401025|SUPERIORITY||Risk Difference (RD)|-1.5|STANDARD_ERROR_OF_MEAN|6.9||0.5883|TWO_SIDED|90.0|-12.9|9.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 1 (Average Pain)||9.8|-12.9|0.5883
70949669|NCT04092452|141401025|SUPERIORITY||Risk Difference (RD)|2.7|STANDARD_ERROR_OF_MEAN|9.07||0.3829|TWO_SIDED|90.0|-12.2|17.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 2 (Average Pain)||17.6|-12.2|0.3829
70949670|NCT04092452|141401025|SUPERIORITY||Risk Difference (RD)|18.2|STANDARD_ERROR_OF_MEAN|9.54||0.0316|TWO_SIDED|90.0|2.5|33.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 2 (Average Pain)||33.9|2.5|0.0316
70949671|NCT04092452|141401025|SUPERIORITY||Risk Difference (RD)|4.6|STANDARD_ERROR_OF_MEAN|9.17||0.3072|TWO_SIDED|90.0|-10.5|19.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 2 (Average Pain)||19.7|-10.5|0.3072
71141385|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|1.37||||0.6443|TWO_SIDED|95.0|0.36|5.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.15|0.36|0.6443
70949672|NCT04092452|141401025|SUPERIORITY||Risk Difference (RD)|-13.1|STANDARD_ERROR_OF_MEAN|10.18||0.8952|TWO_SIDED|90.0|-29.8|3.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 4 (Average Pain)||3.7|-29.8|0.8952
70949673|NCT04092452|141401025|SUPERIORITY||Risk Difference (RD)|13.1|STANDARD_ERROR_OF_MEAN|10.76||0.1157|TWO_SIDED|90.0|-4.6|30.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 4 (Average Pain)||30.8|-4.6|0.1157
70949674|NCT04092452|141401025|SUPERIORITY||Risk Difference (RD)|0.9|STANDARD_ERROR_OF_MEAN|10.93||0.4672|TWO_SIDED|90.0|-17.1|18.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 4 (Average Pain)||18.9|-17.1|0.4672
70949675|NCT04092452|141401025|SUPERIORITY||Risk Difference (RD)|-16.9|STANDARD_ERROR_OF_MEAN|11.29||0.9287|TWO_SIDED|90.0|-35.5|1.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 6 (Average Pain)||1.6|-35.5|0.9287
70949676|NCT04092452|141401025|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|10.85||0.4984|TWO_SIDED|90.0|-17.8|17.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 6 (Average Pain)||17.9|-17.8|0.4984
70949677|NCT04092452|141401025|SUPERIORITY||Risk Difference (RD)|-14.7|STANDARD_ERROR_OF_MEAN|11.27||0.9001|TWO_SIDED|90.0|-33.2|3.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 6 (Average Pain)||3.9|-33.2|0.9001
70949678|NCT04092452|141401025|SUPERIORITY||Risk Difference (RD)|-10.3|STANDARD_ERROR_OF_MEAN|10.53||0.8319|TWO_SIDED|90.0|-27.6|7.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8 (Average Pain)||7.0|-27.6|0.8319
70949679|NCT04092452|141401025|SUPERIORITY||Risk Difference (RD)|19.7|STANDARD_ERROR_OF_MEAN|10.55||0.034|TWO_SIDED|90.0|2.3|37.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8 (Average Pain)||37.0|2.3|0.0340
70949680|NCT04092452|141401025|SUPERIORITY||Risk Difference (RD)|-6.8|STANDARD_ERROR_OF_MEAN|10.7||0.7359|TWO_SIDED|90.0|-24.4|10.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8 (Average Pain)||10.8|-24.4|0.7359
70949681|NCT04092452|141401025|SUPERIORITY||Risk Difference (RD)|-16.0|STANDARD_ERROR_OF_MEAN|10.51||0.9291|TWO_SIDED|90.0|-33.3|1.3||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12 (Average Pain)||1.3|-33.3|0.9291
70949682|NCT04092452|141401025|SUPERIORITY||Risk Difference (RD)|-0.2|STANDARD_ERROR_OF_MEAN|10.44||0.5087|TWO_SIDED|90.0|-17.4|16.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12 (Average Pain)||16.9|-17.4|0.5087
70949683|NCT04092452|141401025|SUPERIORITY||Risk Difference (RD)|-9.5|STANDARD_ERROR_OF_MEAN|10.74||0.8098|TWO_SIDED|90.0|-27.2|8.1||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12 (Average Pain)||8.1|-27.2|0.8098
70949684|NCT04092452|141401025|SUPERIORITY||Risk Difference (RD)|-8.8|STANDARD_ERROR_OF_MEAN|9.76||0.8114|TWO_SIDED|90.0|-24.8|7.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16 (Average Pain)||7.2|-24.8|0.8114
71141386|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|1.58||||0.4865|TWO_SIDED|95.0|0.43|5.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.76|0.43|0.4865
70949685|NCT04092452|141401025|SUPERIORITY||Risk Difference (RD)|10.8|STANDARD_ERROR_OF_MEAN|10.44||0.1531|TWO_SIDED|90.0|-6.4|28.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16 (Average Pain)||28.0|-6.4|0.1531
70949686|NCT04092452|141401025|SUPERIORITY||Risk Difference (RD)|3.3|STANDARD_ERROR_OF_MEAN|10.58||0.3784|TWO_SIDED|90.0|-14.1|20.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16 (Average Pain)||20.7|-14.1|0.3784
70949687|NCT04092452|141401026|SUPERIORITY||Risk Difference (RD)|-7.44|STANDARD_ERROR_OF_MEAN|6.661||0.1321|TWO_SIDED|90.0|-18.39|3.52||One-sided p-value|ANCOVA|||Week 1 Pain at its Worst||3.52|-18.39|0.1321
70949688|NCT04092452|141401026|SUPERIORITY||Risk Difference (RD)|-10.52|STANDARD_ERROR_OF_MEAN|6.308||0.0477|TWO_SIDED|90.0|-20.9|-0.14||One-sided p-value|ANCOVA|||Week 1 Pain at its Worst||-0.14|-20.90|0.0477
70949689|NCT04092452|141401026|SUPERIORITY||Risk Difference (RD)|-14.13|STANDARD_ERROR_OF_MEAN|6.379||0.0134|TWO_SIDED|90.0|-24.62|-3.63||One-sided p-value|ANCOVA|||Week 1 Pain at its Worst||-3.63|-24.62|0.0134
70949690|NCT04092452|141401026|SUPERIORITY||Risk Difference (RD)|-5.66|STANDARD_ERROR_OF_MEAN|8.38||0.2496|TWO_SIDED|90.0|-19.45|8.12||One-sided p-value|ANCOVA|||Week 2 Pain at its Worst||8.12|-19.45|0.2496
70949691|NCT04092452|141401026|SUPERIORITY||Risk Difference (RD)|-11.92|STANDARD_ERROR_OF_MEAN|7.972||0.0675|TWO_SIDED|90.0|-25.03|1.2||One-sided p-value|ANCOVA|||Week 2 Pain at its Worst||1.20|-25.03|0.0675
71141387|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|2.52||||0.1628|TWO_SIDED|95.0|0.69|9.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.27|0.69|0.1628
71141388|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|0.79||||0.6935|TWO_SIDED|95.0|0.24|2.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.57|0.24|0.6935
70949692|NCT04092452|141401026|SUPERIORITY||Risk Difference (RD)|-11.71|STANDARD_ERROR_OF_MEAN|8.054||0.073|TWO_SIDED|90.0|-24.96|1.54||One-sided p-value|ANCOVA|||Week 2 Pain at its Worst||1.54|-24.96|0.0730
70949693|NCT04092452|141401026|SUPERIORITY||Risk Difference (RD)|3.25|STANDARD_ERROR_OF_MEAN|8.892||0.6426|TWO_SIDED|90.0|-11.38|17.88||One-sided p-value|ANCOVA|||Week 4 Pain at its Worst||17.88|-11.38|0.6426
70949694|NCT04092452|141401026|SUPERIORITY||Risk Difference (RD)|-7.82|STANDARD_ERROR_OF_MEAN|8.457||0.1776|TWO_SIDED|90.0|-21.73|6.09||One-sided p-value|ANCOVA|||Week 4 Pain at its Worst||6.09|-21.73|0.1776
70949695|NCT04092452|141401026|SUPERIORITY||Risk Difference (RD)|-1.17|STANDARD_ERROR_OF_MEAN|8.579||0.4458|TWO_SIDED|90.0|-15.28|12.94||One-sided p-value|ANCOVA|||Week 4 Pain at its Worst||12.94|-15.28|0.4458
70949696|NCT04092452|141401026|SUPERIORITY||Risk Difference (RD)|7.94|STANDARD_ERROR_OF_MEAN|9.566||0.7969|TWO_SIDED|90.0|-7.79|23.68||One-sided p-value|ANCOVA|||Week 6 Pain at its Worst||23.68|-7.79|0.7969
70949697|NCT04092452|141401026|SUPERIORITY||Risk Difference (RD)|-11.09|STANDARD_ERROR_OF_MEAN|9.12||0.112|TWO_SIDED|90.0|-26.09|3.91||One-sided p-value|ANCOVA|||Week 6 Pain at its Worst||3.91|-26.09|0.1120
70949698|NCT04092452|141401026|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|9.188||0.5021|TWO_SIDED|90.0|-15.06|15.16||One-sided p-value|ANCOVA|||Week 6 Pain at its Worst||15.16|-15.06|0.5021
70949699|NCT04092452|141401026|SUPERIORITY||Risk Difference (RD)|2.83|STANDARD_ERROR_OF_MEAN|9.296||0.6197|TWO_SIDED|90.0|-12.46|18.12||One-sided p-value|ANCOVA|||Week 8 Pain at its Worst||18.12|-12.46|0.6197
70949700|NCT04092452|141401026|SUPERIORITY||Risk Difference (RD)|-11.3|STANDARD_ERROR_OF_MEAN|8.825||0.1003|TWO_SIDED|90.0|-25.81|3.22||One-sided p-value|ANCOVA|||Week 8 Pain at its Worst||3.22|-25.81|0.1003
70949701|NCT04092452|141401026|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|8.908||0.507|TWO_SIDED|90.0|-14.5|14.81||One-sided p-value|ANCOVA|||Week 8 Pain at its Worst||14.81|-14.50|0.5070
70949702|NCT04092452|141401026|SUPERIORITY||Risk Difference (RD)|0.67|STANDARD_ERROR_OF_MEAN|9.368||0.5283|TWO_SIDED|90.0|-14.74|16.08||One-sided p-value|ANCOVA|||Week 12 Pain at its Worst||16.08|-14.74|0.5283
70949703|NCT04092452|141401026|SUPERIORITY||Risk Difference (RD)|-15.31|STANDARD_ERROR_OF_MEAN|8.921||0.0431|TWO_SIDED|90.0|-29.98|-0.63||One-sided p-value|ANCOVA|||Week 12 Pain at its Worst||-0.63|-29.98|0.0431
70949704|NCT04092452|141401026|SUPERIORITY||Risk Difference (RD)|-6.39|STANDARD_ERROR_OF_MEAN|9.02||0.2395|TWO_SIDED|90.0|-21.22|8.45||One-sided p-value|ANCOVA|||Week 12 Pain at its Worst||8.45|-21.22|0.2395
70949705|NCT04092452|141401026|SUPERIORITY||Risk Difference (RD)|2.57|STANDARD_ERROR_OF_MEAN|9.617||0.6054|TWO_SIDED|90.0|-13.25|18.39||One-sided p-value|ANCOVA|||Week 16 Pain at its Worst||18.39|-13.25|0.6054
71141389|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9753|TWO_SIDED|95.0|0.32|3.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.28|0.32|0.9753
71141390|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|0.81||||0.7407|TWO_SIDED|95.0|0.23|2.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.81|0.23|0.7407
71141391|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|1.55||||0.4929|TWO_SIDED|95.0|0.44|5.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.49|0.44|0.4929
71141392|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|0.88||||0.8496|TWO_SIDED|95.0|0.25|3.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.15|0.25|0.8496
71141393|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|1.92||||0.3248|TWO_SIDED|95.0|0.52|7.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||7.05|0.52|0.3248
71141394|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|2.03||||0.2589|TWO_SIDED|95.0|0.59|6.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||6.92|0.59|0.2589
71141395|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|0.54||||0.3318|TWO_SIDED|95.0|0.16|1.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.87|0.16|0.3318
71141396|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|0.89||||0.8536|TWO_SIDED|95.0|0.26|3.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.01|0.26|0.8536
70866835|NCT02609828|141220096|SUPERIORITY||Odds Ratio (OR)|1.84||||0.0918|TWO_SIDED|95.0|0.91|3.74|||Regression, Logistic|||Week 12 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.74|0.91|0.0918
70866836|NCT02609828|141220096|SUPERIORITY||Odds Ratio (OR)|2.13||||0.0704|TWO_SIDED|95.0|0.94|4.82|||Regression, Logistic|||Week 12 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.82|0.94|0.0704
71141397|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|0.48||||0.2817|TWO_SIDED|95.0|0.12|1.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.84|0.12|0.2817
71141398|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|0.59||||0.4091|TWO_SIDED|95.0|0.17|2.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.07|0.17|0.4091
71141399|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|0.5||||0.3147|TWO_SIDED|95.0|0.13|1.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.93|0.13|0.3147
71141400|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|0.89||||0.8547|TWO_SIDED|95.0|0.24|3.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.24|0.24|0.8547
71141401|NCT03192176|141778534|SUPERIORITY||Odds Ratio (OR)|0.66||||0.5023|TWO_SIDED|95.0|0.2|2.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.19|0.20|0.5023
71141402|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|3.99||||0.0093|TWO_SIDED|95.0|1.41|11.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||11.35|1.41|0.0093
70866837|NCT02609828|141220096|SUPERIORITY||Odds Ratio (OR)|1.67||||0.3569|TWO_SIDED|95.0|0.56|5.01|||Regression, Logistic|||Week 12 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.01|0.56|0.3569
70866838|NCT02609828|141220096|SUPERIORITY||Odds Ratio (OR)|2.46||||0.3062|TWO_SIDED|95.0|0.44|13.79|||Regression, Logistic|||Week 12 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||13.79|0.44|0.3062
70866839|NCT02609828|141220096|SUPERIORITY||Odds Ratio (OR)|1.84||||0.1058|TWO_SIDED|95.0|0.88|3.85|||Regression, Logistic|||Week 16 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.85|0.88|0.1058
70866840|NCT02609828|141220096|SUPERIORITY||Odds Ratio (OR)|1.81||||0.1571|TWO_SIDED|95.0|0.79|4.14|||Regression, Logistic|||Week 16 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.14|0.79|0.1571
70866841|NCT02609828|141220096|SUPERIORITY||Odds Ratio (OR)|1.85||||0.2454|TWO_SIDED|95.0|0.65|5.24|||Regression, Logistic|||Week 16 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.24|0.65|0.2454
71141403|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|4.66||||0.0035|TWO_SIDED|95.0|1.66|13.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||13.09|1.66|0.0035
71141404|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|8.48|||<|0.0001|TWO_SIDED|95.0|3.01|23.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||23.90|3.01|<0.0001
71141405|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|7.57||||0.0002|TWO_SIDED|95.0|2.65|21.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||21.59|2.65|0.0002
70866842|NCT02609828|141220096|SUPERIORITY||Odds Ratio (OR)|0.91||||0.8867|TWO_SIDED|95.0|0.24|3.46|||Regression, Logistic|||Week 16 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.46|0.24|0.8867
70866843|NCT02609828|141220096|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0689|TWO_SIDED|95.0|0.95|4.21|||Regression, Logistic|||Week 24 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.21|0.95|0.0689
70866844|NCT02609828|141220096|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0568|TWO_SIDED|95.0|0.98|5.44|||Regression, Logistic|||Week 24 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.44|0.98|0.0568
70866845|NCT02609828|141220096|SUPERIORITY||Odds Ratio (OR)|2.41||||0.1268|TWO_SIDED|95.0|0.78|7.46|||Regression, Logistic|||Week 24 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||7.46|0.78|0.1268
71141406|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|2.13||||0.1664|TWO_SIDED|95.0|0.73|6.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||6.22|0.73|0.1664
71141407|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|5.39||||0.0012|TWO_SIDED|95.0|1.94|14.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||14.96|1.94|0.0012
71141408|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|9.85|||<|0.0001|TWO_SIDED|95.0|3.49|27.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||27.86|3.49|<0.0001
71141409|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|2.73||||0.0334|TWO_SIDED|95.0|1.08|6.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.89|1.08|0.0334
71141410|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|4.12||||0.0034|TWO_SIDED|95.0|1.6|10.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.62|1.60|0.0034
70949706|NCT04092452|141401026|SUPERIORITY||Risk Difference (RD)|-21.54|STANDARD_ERROR_OF_MEAN|9.344||0.0106|TWO_SIDED|90.0|-36.91|-6.17||One-sided p-value|ANCOVA|||Week 16 Pain at its Worst||-6.17|-36.91|0.0106
71141411|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|6.55||||0.0002|TWO_SIDED|95.0|2.45|17.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||17.47|2.45|0.0002
70949707|NCT04092452|141401026|SUPERIORITY||Risk Difference (RD)|-12.54|STANDARD_ERROR_OF_MEAN|9.305||0.089|TWO_SIDED|90.0|-27.84|2.77||One-sided p-value|ANCOVA|||Week 16 Pain at its Worst||2.77|-27.84|0.0890
70949708|NCT04092452|141401027|SUPERIORITY||Risk Difference (RD)|-6.17|STANDARD_ERROR_OF_MEAN|5.963||0.1505|TWO_SIDED|90.0|-15.98|3.64||One-sided p-value|ANCOVA|||Week 1 Average Pain||3.64|-15.98|0.1505
70949709|NCT04092452|141401027|SUPERIORITY||Risk Difference (RD)|-11.06|STANDARD_ERROR_OF_MEAN|5.555||0.0233|TWO_SIDED|90.0|-20.19|-1.92||One-sided p-value|ANCOVA|||Week 1 Average Pain||-1.92|-20.19|0.0233
71141412|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|4.9||||0.0014|TWO_SIDED|95.0|1.85|12.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.98|1.85|0.0014
71141413|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|2.26||||0.0872|TWO_SIDED|95.0|0.89|5.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.74|0.89|0.0872
71141414|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|3.19||||0.0131|TWO_SIDED|95.0|1.28|7.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.98|1.28|0.0131
71141415|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0386|TWO_SIDED|95.0|1.05|6.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.43|1.05|0.0386
71141416|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|3.11||||0.0191|TWO_SIDED|95.0|1.2|8.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.05|1.20|0.0191
70866846|NCT02609828|141220096|SUPERIORITY||Odds Ratio (OR)|1.23||||0.7971|TWO_SIDED|95.0|0.25|6.0|||Regression, Logistic|||Week 24 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||6.00|0.25|0.7971
70866847|NCT02609828|141220097|SUPERIORITY||Odds Ratio (OR)|1.27||||0.6658|TWO_SIDED|95.0|0.43|3.7|||Regression, Logistic|||Week 1 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.70|0.43|0.6658
70866848|NCT02609828|141220097|SUPERIORITY||Odds Ratio (OR)|3.07||||0.3443|TWO_SIDED|95.0|0.3|31.35|||Regression, Logistic|||Week 1 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||31.35|0.30|0.3443
70949710|NCT04092452|141401027|SUPERIORITY||Risk Difference (RD)|-6.34|STANDARD_ERROR_OF_MEAN|5.926||0.1423|TWO_SIDED|90.0|-16.09|3.41||One-sided p-value|ANCOVA|||Week 1 Average Pain||3.41|-16.09|0.1423
71141417|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|2.84||||0.0291|TWO_SIDED|95.0|1.11|7.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.26|1.11|0.0291
70866849|NCT02609828|141220097|SUPERIORITY|||||||0.9527|||||||Regression, Logistic|||Week 1 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9527
71141418|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|6.09||||0.0004|TWO_SIDED|95.0|2.23|16.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||16.58|2.23|0.0004
70866850|NCT02609828|141220097|SUPERIORITY||Odds Ratio (OR)|2.25||||0.0757|TWO_SIDED|95.0|0.92|5.5|||Regression, Logistic|||Week 2 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.50|0.92|0.0757
70949711|NCT04092452|141401027|SUPERIORITY||Risk Difference (RD)|-2.15|STANDARD_ERROR_OF_MEAN|7.202||0.3827|TWO_SIDED|90.0|-14.0|9.7||One-sided p-value|ANCOVA|||Week 2 Average Pain||9.70|-14.00|0.3827
70949712|NCT04092452|141401027|SUPERIORITY||Risk Difference (RD)|-10.35|STANDARD_ERROR_OF_MEAN|6.741||0.0624|TWO_SIDED|90.0|-21.44|0.74||One-sided p-value|ANCOVA|||Week 2 Average Pain||0.74|-21.44|0.0624
70949713|NCT04092452|141401027|SUPERIORITY||Risk Difference (RD)|-2.25|STANDARD_ERROR_OF_MEAN|7.171||0.3771|TWO_SIDED|90.0|-14.04|9.55||One-sided p-value|ANCOVA|||Week 2 Average Pain||9.55|-14.04|0.3771
70949714|NCT04092452|141401027|SUPERIORITY||Risk Difference (RD)|8.04|STANDARD_ERROR_OF_MEAN|8.614||0.8247|TWO_SIDED|90.0|-6.13|22.21||One-sided p-value|ANCOVA|||Week 4 Average Pain||22.21|-6.13|0.8247
70949715|NCT04092452|141401027|SUPERIORITY||Risk Difference (RD)|-8.97|STANDARD_ERROR_OF_MEAN|8.09||0.1337|TWO_SIDED|90.0|-22.28|4.33||One-sided p-value|ANCOVA|||Week 4 Average Pain||4.33|-22.28|0.1337
70949716|NCT04092452|141401027|SUPERIORITY||Risk Difference (RD)|5.37|STANDARD_ERROR_OF_MEAN|8.523||0.7357|TWO_SIDED|90.0|-8.65|19.39||One-sided p-value|ANCOVA|||Week 4 Average Pain||19.39|-8.65|0.7357
70949717|NCT04092452|141401027|SUPERIORITY||Risk Difference (RD)|13.78|STANDARD_ERROR_OF_MEAN|8.977||0.9377|TWO_SIDED|90.0|-0.98|28.55||One-sided p-value|ANCOVA|||Week 6 Average Pain||28.55|-0.98|0.9377
70949718|NCT04092452|141401027|SUPERIORITY||Risk Difference (RD)|-9.39|STANDARD_ERROR_OF_MEAN|8.45||0.1332|TWO_SIDED|90.0|-23.29|4.51||One-sided p-value|ANCOVA|||Week 6 Average Pain||4.51|-23.29|0.1332
70949719|NCT04092452|141401027|SUPERIORITY||Risk Difference (RD)|6.05|STANDARD_ERROR_OF_MEAN|8.907||0.7514|TWO_SIDED|90.0|-8.6|20.7||One-sided p-value|ANCOVA|||Week 6 Average Pain||20.70|-8.60|0.7514
70949720|NCT04092452|141401027|SUPERIORITY||Risk Difference (RD)|8.97|STANDARD_ERROR_OF_MEAN|8.902||0.8433|TWO_SIDED|90.0|-5.67|23.62||One-sided p-value|ANCOVA|||Week 8 Average Pain||23.62|-5.67|0.8433
70866851|NCT02609828|141220097|SUPERIORITY||Odds Ratio (OR)|4.51||||0.0659|TWO_SIDED|95.0|0.91|22.42|||Regression, Logistic|||Week 2 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||22.42|0.91|0.0659
70949721|NCT04092452|141401027|SUPERIORITY||Risk Difference (RD)|-8.84|STANDARD_ERROR_OF_MEAN|8.392||0.1461|TWO_SIDED|90.0|-22.64|4.96||One-sided p-value|ANCOVA|||Week 8 Average Pain||4.96|-22.64|0.1461
71141419|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|7.24||||0.0003|TWO_SIDED|95.0|2.49|21.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||21.02|2.49|0.0003
70949722|NCT04092452|141401027|SUPERIORITY||Risk Difference (RD)|8.64|STANDARD_ERROR_OF_MEAN|8.818||0.8364|TWO_SIDED|90.0|-5.86|23.15||One-sided p-value|ANCOVA|||Week 8 Average Pain||23.15|-5.86|0.8364
70949723|NCT04092452|141401027|SUPERIORITY||Risk Difference (RD)|2.35|STANDARD_ERROR_OF_MEAN|8.527||0.6085|TWO_SIDED|90.0|-11.68|16.37||One-sided p-value|ANCOVA|||Week 12 Average Pain||16.37|-11.68|0.6085
70949724|NCT04092452|141401027|SUPERIORITY||Risk Difference (RD)|-14.38|STANDARD_ERROR_OF_MEAN|8.022||0.0365|TWO_SIDED|90.0|-27.58|-1.19||One-sided p-value|ANCOVA|||Week 12 Average Pain||-1.19|-27.58|0.0365
70949725|NCT04092452|141401027|SUPERIORITY||Risk Difference (RD)|0.43|STANDARD_ERROR_OF_MEAN|8.469||0.5201|TWO_SIDED|90.0|-13.5|14.36||One-sided p-value|ANCOVA|||Week 12 Average Pain||14.36|-13.50|0.5201
70949726|NCT04092452|141401027|SUPERIORITY||Risk Difference (RD)|4.04|STANDARD_ERROR_OF_MEAN|8.564||0.6813|TWO_SIDED|90.0|-10.05|18.12||One-sided p-value|ANCOVA|||Week 16 Average Pain||18.12|-10.05|0.6813
70949727|NCT04092452|141401027|SUPERIORITY||Risk Difference (RD)|-18.38|STANDARD_ERROR_OF_MEAN|8.23||0.0128|TWO_SIDED|90.0|-31.91|-4.84||One-sided p-value|ANCOVA|||Week 16 Average Pain||-4.84|-31.91|0.0128
70949728|NCT04092452|141401027|SUPERIORITY||Risk Difference (RD)|-4.09|STANDARD_ERROR_OF_MEAN|8.639||0.3181|TWO_SIDED|90.0|-18.3|10.12||One-sided p-value|ANCOVA|||Week 16 Average Pain||10.12|-18.30|0.3181
70949729|NCT04092452|141401028|SUPERIORITY||Risk Difference (RD)|-0.31|STANDARD_ERROR_OF_MEAN|0.301||0.1536|TWO_SIDED|90.0|-0.8|0.19||One-sided p-value|ANCOVA|||Week 1 Pain at its Worst||0.19|-0.80|0.1536
70949730|NCT04092452|141401028|SUPERIORITY||Risk Difference (RD)|-0.45|STANDARD_ERROR_OF_MEAN|0.289||0.0581|TWO_SIDED|90.0|-0.93|0.02||One-sided p-value|ANCOVA|||Week 1 Pain at its Worst||0.02|-0.93|0.0581
70949731|NCT04092452|141401028|SUPERIORITY||Risk Difference (RD)|-0.48|STANDARD_ERROR_OF_MEAN|0.3||0.0532|TWO_SIDED|90.0|-0.98|0.01||One-sided p-value|ANCOVA|||Week 1 Pain at its Worst||0.01|-0.98|0.0532
70949732|NCT04092452|141401028|SUPERIORITY||Risk Difference (RD)|-0.32|STANDARD_ERROR_OF_MEAN|0.383||0.2007|TWO_SIDED|90.0|-0.95|0.31||One-sided p-value|ANCOVA|||Week 2 Pain at its Worst||0.31|-0.95|0.2007
71141420|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|2.22||||0.0992|TWO_SIDED|95.0|0.86|5.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||5.72|0.86|0.0992
70866852|NCT02609828|141220097|SUPERIORITY|||||||0.938|||||||Regression, Logistic|||Week 2 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9380
70866853|NCT02609828|141220097|SUPERIORITY|||||||0.9493|||||||Regression, Logistic|||Week 2 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9493
70949733|NCT04092452|141401028|SUPERIORITY||Risk Difference (RD)|-0.55|STANDARD_ERROR_OF_MEAN|0.37||0.0694|TWO_SIDED|90.0|-1.16|0.06||One-sided p-value|ANCOVA|||Week 2 Pain at its Worst||0.06|-1.16|0.0694
70949734|NCT04092452|141401028|SUPERIORITY||Risk Difference (RD)|-0.39|STANDARD_ERROR_OF_MEAN|0.382||0.1509|TWO_SIDED|90.0|-1.02|0.23||One-sided p-value|ANCOVA|||Week 2 Pain at its Worst||0.23|-1.02|0.1509
70949735|NCT04092452|141401028|SUPERIORITY||Risk Difference (RD)|0.07|STANDARD_ERROR_OF_MEAN|0.431||0.5663|TWO_SIDED|90.0|-0.64|0.78||One-sided p-value|ANCOVA|||Week 4 Pain at its Worst||0.78|-0.64|0.5663
70866854|NCT02609828|141220097|SUPERIORITY||Odds Ratio (OR)|2.02||||0.0914|TWO_SIDED|95.0|0.89|4.59|||Regression, Logistic|||Week 4 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.59|0.89|0.0914
70866855|NCT02609828|141220097|SUPERIORITY||Odds Ratio (OR)|3.22||||0.0359|TWO_SIDED|95.0|1.08|9.61|||Regression, Logistic|||Week 4 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||9.61|1.08|0.0359
70949736|NCT04092452|141401028|SUPERIORITY||Risk Difference (RD)|-0.45|STANDARD_ERROR_OF_MEAN|0.416||0.1396|TWO_SIDED|90.0|-1.13|0.23||One-sided p-value|ANCOVA|||Week 4 Pain at its Worst||0.23|-1.13|0.1396
70866856|NCT02609828|141220097|SUPERIORITY|||||||0.9538|||||||Regression, Logistic|||Week 4 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9538
70949737|NCT04092452|141401028|SUPERIORITY||Risk Difference (RD)|0.02|STANDARD_ERROR_OF_MEAN|0.432||0.5227|TWO_SIDED|90.0|-0.69|0.74||One-sided p-value|ANCOVA|||Week 4 Pain at its Worst||0.74|-0.69|0.5227
70949738|NCT04092452|141401028|SUPERIORITY||Risk Difference (RD)|0.5|STANDARD_ERROR_OF_MEAN|0.45||0.8656|TWO_SIDED|90.0|-0.24|1.24||One-sided p-value|ANCOVA|||Week 6 Pain at its Worst||1.24|-0.24|0.8656
70949739|NCT04092452|141401028|SUPERIORITY||Risk Difference (RD)|-0.42|STANDARD_ERROR_OF_MEAN|0.434||0.1671|TWO_SIDED|90.0|-1.13|0.29||One-sided p-value|ANCOVA|||Week 6 Pain at its Worst||0.29|-1.13|0.1671
70949740|NCT04092452|141401028|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.45||0.6063|TWO_SIDED|90.0|-0.62|0.86||One-sided p-value|ANCOVA|||Week 6 Pain at its Worst||0.86|-0.62|0.6063
70949741|NCT04092452|141401028|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.458||0.6402|TWO_SIDED|90.0|-0.59|0.92||One-sided p-value|ANCOVA|||Week 8 Pain at its Worst||0.92|-0.59|0.6402
70949742|NCT04092452|141401028|SUPERIORITY||Risk Difference (RD)|-0.38|STANDARD_ERROR_OF_MEAN|0.441||0.1916|TWO_SIDED|90.0|-1.11|0.34||One-sided p-value|ANCOVA|||Week 8 Pain at its Worst||0.34|-1.11|0.1916
70866857|NCT02609828|141220097|SUPERIORITY|||||||0.9493|||||||Regression, Logistic|||Week 4 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9493
70866858|NCT02609828|141220097|SUPERIORITY||Odds Ratio (OR)|2.66||||0.0143|TWO_SIDED|95.0|1.22|5.8|||Regression, Logistic|||Week 6 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.80|1.22|0.0143
70866859|NCT02609828|141220097|SUPERIORITY||Odds Ratio (OR)|4.2||||0.0176|TWO_SIDED|95.0|1.28|13.74|||Regression, Logistic|||Week 6 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||13.74|1.28|0.0176
70866860|NCT02609828|141220097|SUPERIORITY||Odds Ratio (OR)|3.53||||0.1298|TWO_SIDED|95.0|0.69|18.06|||Regression, Logistic|||Week 6 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||18.06|0.69|0.1298
70866861|NCT02609828|141220097|SUPERIORITY|||||||0.9493|||||||Regression, Logistic|||Week 6 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9493
70866862|NCT02609828|141220097|SUPERIORITY||Odds Ratio (OR)|2.15||||0.0527|TWO_SIDED|95.0|0.99|4.67|||Regression, Logistic|||Week 8 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.67|0.99|0.0527
70866863|NCT02609828|141220097|SUPERIORITY||Odds Ratio (OR)|2.69||||0.0457|TWO_SIDED|95.0|1.02|7.12|||Regression, Logistic|||Week 8 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||7.12|1.02|0.0457
70866864|NCT02609828|141220097|SUPERIORITY||Odds Ratio (OR)|3.91||||0.0994|TWO_SIDED|95.0|0.77|19.76|||Regression, Logistic|||Week 8 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||19.76|0.77|0.0994
70866865|NCT02609828|141220097|SUPERIORITY||Odds Ratio (OR)|0.65||||0.6977|TWO_SIDED|95.0|0.07|5.86|||Regression, Logistic|||Week 8 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.86|0.07|0.6977
70949743|NCT04092452|141401028|SUPERIORITY||Risk Difference (RD)|0.13|STANDARD_ERROR_OF_MEAN|0.456||0.6119|TWO_SIDED|90.0|-0.62|0.88||One-sided p-value|ANCOVA|||Week 8 Pain at its Worst||0.88|-0.62|0.6119
70866866|NCT02609828|141220097|SUPERIORITY||Odds Ratio (OR)|1.76||||0.146|TWO_SIDED|95.0|0.82|3.75|||Regression, Logistic|||Week 12 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.75|0.82|0.1460
70866867|NCT02609828|141220097|SUPERIORITY||Odds Ratio (OR)|2.35||||0.0742|TWO_SIDED|95.0|0.92|6.01|||Regression, Logistic|||Week 12 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||6.01|0.92|0.0742
70949744|NCT04092452|141401028|SUPERIORITY||Risk Difference (RD)|0.06|STANDARD_ERROR_OF_MEAN|0.45||0.5568|TWO_SIDED|90.0|-0.68|0.8||One-sided p-value|ANCOVA|||Week 12 Pain at its Worst||0.80|-0.68|0.5568
70949745|NCT04092452|141401028|SUPERIORITY||Risk Difference (RD)|-0.56|STANDARD_ERROR_OF_MEAN|0.433||0.0976|TWO_SIDED|90.0|-1.27|0.15||One-sided p-value|ANCOVA|||Week 12 Pain at its Worst||0.15|-1.27|0.0976
70949746|NCT04092452|141401028|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|0.451||0.5001|TWO_SIDED|90.0|-0.74|0.74||One-sided p-value|ANCOVA|||Week 12 Pain at its Worst||0.74|-0.74|0.5001
70949747|NCT04092452|141401028|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.451||0.581|TWO_SIDED|90.0|-0.65|0.83||One-sided p-value|ANCOVA|||Week 16 Pain at its Worst||0.83|-0.65|0.5810
70949748|NCT04092452|141401028|SUPERIORITY||Risk Difference (RD)|-1.07|STANDARD_ERROR_OF_MEAN|0.442||0.0079|TWO_SIDED|90.0|-1.8|-0.34||One-sided p-value|ANCOVA|||Week 16 Pain at its Worst||-0.34|-1.80|0.0079
70949749|NCT04092452|141401028|SUPERIORITY||Risk Difference (RD)|-0.57|STANDARD_ERROR_OF_MEAN|0.455||0.1068|TWO_SIDED|90.0|-1.31|0.18||One-sided p-value|ANCOVA|||Week 16 Pain at its Worst||0.18|-1.31|0.1068
70949750|NCT04092452|141401029|SUPERIORITY||Risk Difference (RD)|-0.25|STANDARD_ERROR_OF_MEAN|0.284||0.1898|TWO_SIDED|90.0|-0.72|0.22||One-sided p-value|ANCOVA|||Week 1 Average Pain||0.22|-0.72|0.1898
70949751|NCT04092452|141401029|SUPERIORITY||Risk Difference (RD)|-0.43|STANDARD_ERROR_OF_MEAN|0.273||0.0562|TWO_SIDED|90.0|-0.88|0.02||One-sided p-value|ANCOVA|||Week 1 Average Pain||0.02|-0.88|0.0562
70949752|NCT04092452|141401029|SUPERIORITY||Risk Difference (RD)|-0.31|STANDARD_ERROR_OF_MEAN|0.284||0.1382|TWO_SIDED|90.0|-0.78|0.16||One-sided p-value|ANCOVA|||Week 1 Average Pain||0.16|-0.78|0.1382
70949753|NCT04092452|141401029|SUPERIORITY||Risk Difference (RD)|-0.28|STANDARD_ERROR_OF_MEAN|0.343||0.2039|TWO_SIDED|90.0|-0.85|0.28||One-sided p-value|ANCOVA|||Week 2 Average Pain||0.28|-0.85|0.2039
70949754|NCT04092452|141401029|SUPERIORITY||Risk Difference (RD)|-0.45|STANDARD_ERROR_OF_MEAN|0.332||0.0855|TWO_SIDED|90.0|-1.0|0.09||One-sided p-value|ANCOVA|||Week 2 Average Pain||0.09|-1.00|0.0855
70949755|NCT04092452|141401029|SUPERIORITY||Risk Difference (RD)|-0.17|STANDARD_ERROR_OF_MEAN|0.344||0.3089|TWO_SIDED|90.0|-0.74|0.39||One-sided p-value|ANCOVA|||Week 2 Average Pain||0.39|-0.74|0.3089
70949756|NCT04092452|141401029|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.407||0.6124|TWO_SIDED|90.0|-0.55|0.79||One-sided p-value|ANCOVA|||Week 4 Average Pain||0.79|-0.55|0.6124
71141421|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|5.66||||0.0006|TWO_SIDED|95.0|2.11|15.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||15.16|2.11|0.0006
71141422|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|3.74||||0.006|TWO_SIDED|95.0|1.46|9.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.59|1.46|0.0060
71141423|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|2.01||||0.1472|TWO_SIDED|95.0|0.78|5.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.14|0.78|0.1472
71141424|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|2.05||||0.1284|TWO_SIDED|95.0|0.81|5.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.15|0.81|0.1284
71141425|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|3.55||||0.0117|TWO_SIDED|95.0|1.32|9.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||9.50|1.32|0.0117
71141426|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|4.24||||0.0067|TWO_SIDED|95.0|1.49|12.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||12.03|1.49|0.0067
71141427|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|1.47||||0.4088|TWO_SIDED|95.0|0.59|3.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||3.71|0.59|0.4088
70949757|NCT04092452|141401029|SUPERIORITY||Risk Difference (RD)|-0.5|STANDARD_ERROR_OF_MEAN|0.395||0.1003|TWO_SIDED|90.0|-1.15|0.14||One-sided p-value|ANCOVA|||Week 4 Average Pain||0.14|-1.15|0.1003
71141428|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|3.09||||0.0194|TWO_SIDED|95.0|1.2|7.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.96|1.20|0.0194
71141429|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0423|TWO_SIDED|95.0|1.03|6.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.73|1.03|0.0423
71141430|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|1.86||||0.2151|TWO_SIDED|95.0|0.7|4.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.99|0.70|0.2151
71141431|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|2.71||||0.0531|TWO_SIDED|95.0|0.99|7.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.42|0.99|0.0531
71141432|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|4.11||||0.0118|TWO_SIDED|95.0|1.37|12.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||12.34|1.37|0.0118
71141433|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|16.28||||0.0006|TWO_SIDED|95.0|3.29|80.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||80.46|3.29|0.0006
71141434|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|1.57||||0.3698|TWO_SIDED|95.0|0.59|4.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.22|0.59|0.3698
71141435|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|4.58||||0.0059|TWO_SIDED|95.0|1.55|13.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||13.53|1.55|0.0059
70866868|NCT02609828|141220097|SUPERIORITY||Odds Ratio (OR)|1.44||||0.5565|TWO_SIDED|95.0|0.42|4.91|||Regression, Logistic|||Week 12 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.91|0.42|0.5565
70866869|NCT02609828|141220097|SUPERIORITY||Odds Ratio (OR)|1.7||||0.5623|TWO_SIDED|95.0|0.28|10.35|||Regression, Logistic|||Week 12 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||10.35|0.28|0.5623
70866870|NCT02609828|141220097|SUPERIORITY||Odds Ratio (OR)|2.86||||0.0116|TWO_SIDED|95.0|1.27|6.47|||Regression, Logistic|||Week 16 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||6.47|1.27|0.0116
70866871|NCT02609828|141220097|SUPERIORITY||Odds Ratio (OR)|2.34||||0.0615|TWO_SIDED|95.0|0.96|5.7|||Regression, Logistic|||Week 16 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.70|0.96|0.0615
70866872|NCT02609828|141220097|SUPERIORITY||Odds Ratio (OR)|1.68||||0.3316|TWO_SIDED|95.0|0.59|4.8|||Regression, Logistic|||Week 16 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.80|0.59|0.3316
70949758|NCT04092452|141401029|SUPERIORITY||Risk Difference (RD)|0.2|STANDARD_ERROR_OF_MEAN|0.408||0.6875|TWO_SIDED|90.0|-0.47|0.87||One-sided p-value|ANCOVA|||Week 4 Average Pain||0.87|-0.47|0.6875
70949759|NCT04092452|141401029|SUPERIORITY||Risk Difference (RD)|0.51|STANDARD_ERROR_OF_MEAN|0.427||0.8833|TWO_SIDED|90.0|-0.19|1.21||One-sided p-value|ANCOVA|||Week 6 Average Pain||1.21|-0.19|0.8833
70866873|NCT02609828|141220097|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9946|TWO_SIDED|95.0|0.19|5.33|||Regression, Logistic|||Week 16 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.33|0.19|0.9946
70866874|NCT02609828|141220097|SUPERIORITY||Odds Ratio (OR)|2.99||||0.0083|TWO_SIDED|95.0|1.33|6.76|||Regression, Logistic|||Week 24 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||6.76|1.33|0.0083
70866875|NCT02609828|141220097|SUPERIORITY||Odds Ratio (OR)|2.42||||0.0513|TWO_SIDED|95.0|1.0|5.88|||Regression, Logistic|||Week 24 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.88|1.00|0.0513
70949760|NCT04092452|141401029|SUPERIORITY||Risk Difference (RD)|-0.43|STANDARD_ERROR_OF_MEAN|0.413||0.1502|TWO_SIDED|90.0|-1.11|0.25||One-sided p-value|ANCOVA|||Week 6 Average Pain||0.25|-1.11|0.1502
70949761|NCT04092452|141401029|SUPERIORITY||Risk Difference (RD)|0.2|STANDARD_ERROR_OF_MEAN|0.428||0.6788|TWO_SIDED|90.0|-0.5|0.9||One-sided p-value|ANCOVA|||Week 6 Average Pain||0.90|-0.50|0.6788
71141436|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|3.32||||0.0241|TWO_SIDED|95.0|1.17|9.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||9.44|1.17|0.0241
71141437|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|1.38||||0.5308|TWO_SIDED|95.0|0.5|3.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.77|0.50|0.5308
71141438|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|1.09||||0.8603|TWO_SIDED|95.0|0.41|2.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||2.90|0.41|0.8603
71141439|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|3.73||||0.0264|TWO_SIDED|95.0|1.17|11.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||11.95|1.17|0.0264
71141440|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|4.6||||0.0188|TWO_SIDED|95.0|1.29|16.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||16.42|1.29|0.0188
71141441|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|1.17||||0.7642|TWO_SIDED|95.0|0.42|3.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.27|0.42|0.7642
70949762|NCT04092452|141401029|SUPERIORITY||Risk Difference (RD)|0.21|STANDARD_ERROR_OF_MEAN|0.441||0.6835|TWO_SIDED|90.0|-0.51|0.94||One-sided p-value|ANCOVA|||Week 8 Average Pain||0.94|-0.51|0.6835
70949763|NCT04092452|141401029|SUPERIORITY||Risk Difference (RD)|-0.32|STANDARD_ERROR_OF_MEAN|0.425||0.2237|TWO_SIDED|90.0|-1.02|0.38||One-sided p-value|ANCOVA|||Week 8 Average Pain||0.38|-1.02|0.2237
71141442|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|4.91||||0.0101|TWO_SIDED|95.0|1.46|16.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||16.53|1.46|0.0101
71141443|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|2.88||||0.0572|TWO_SIDED|95.0|0.97|8.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||8.55|0.97|0.0572
71141444|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|1.19||||0.7348|TWO_SIDED|95.0|0.44|3.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||3.20|0.44|0.7348
71141445|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|2.2||||0.1397|TWO_SIDED|95.0|0.77|6.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.25|0.77|0.1397
71141446|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|4.07||||0.0231|TWO_SIDED|95.0|1.21|13.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||13.64|1.21|0.0231
71141447|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|4.54||||0.0196|TWO_SIDED|95.0|1.27|16.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||16.15|1.27|0.0196
71141448|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|1.16||||0.7703|TWO_SIDED|95.0|0.42|3.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||3.24|0.42|0.7703
71141449|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|3.83||||0.0222|TWO_SIDED|95.0|1.21|12.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||12.12|1.21|0.0222
71141450|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|2.77||||0.0668|TWO_SIDED|95.0|0.93|8.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||8.21|0.93|0.0668
71141451|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|1.18||||0.7533|TWO_SIDED|95.0|0.43|3.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.22|0.43|0.7533
71141452|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|1.67||||0.3325|TWO_SIDED|95.0|0.59|4.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.73|0.59|0.3325
71141453|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|2.71||||0.0899|TWO_SIDED|95.0|0.86|8.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||8.57|0.86|0.0899
71141454|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|3.31||||0.0642|TWO_SIDED|95.0|0.93|11.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||11.79|0.93|0.0642
71141455|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|1.34||||0.5964|TWO_SIDED|95.0|0.46|3.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.89|0.46|0.5964
71141456|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|4.43||||0.0224|TWO_SIDED|95.0|1.23|15.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||15.91|1.23|0.0224
70866876|NCT02609828|141220097|SUPERIORITY||Odds Ratio (OR)|2.48||||0.1528|TWO_SIDED|95.0|0.71|8.58|||Regression, Logistic|||Week 24 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||8.58|0.71|0.1528
71141457|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|1.72||||0.3139|TWO_SIDED|95.0|0.6|4.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.96|0.60|0.3139
71141458|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|1.3||||0.6343|TWO_SIDED|95.0|0.45|3.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.76|0.45|0.6343
71141459|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|1.27||||0.6557|TWO_SIDED|95.0|0.45|3.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.61|0.45|0.6557
71141460|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|3.66||||0.0516|TWO_SIDED|95.0|0.99|13.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.51|0.99|0.0516
71141461|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|4.38||||0.04|TWO_SIDED|95.0|1.07|17.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||17.91|1.07|0.0400
71141462|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|1.37||||0.5825|TWO_SIDED|95.0|0.44|4.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.24|0.44|0.5825
71141463|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|7.46||||0.0152|TWO_SIDED|95.0|1.47|37.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||37.83|1.47|0.0152
71141464|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|2.3||||0.1565|TWO_SIDED|95.0|0.73|7.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||7.30|0.73|0.1565
70866877|NCT02609828|141220097|SUPERIORITY||Odds Ratio (OR)|1.41||||0.7251|TWO_SIDED|95.0|0.21|9.65|||Regression, Logistic|||Week 24 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||9.65|0.21|0.7251
70866878|NCT02609828|141220098|SUPERIORITY||Difference in LS mean|-0.04|STANDARD_ERROR_OF_MEAN|0.12||0.7045|TWO_SIDED|95.0|-0.28|0.19|||ANCOVA|||Change at Week 2: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.||0.19|-0.28|0.7045
70866879|NCT02609828|141220098|SUPERIORITY||Difference in LS mean|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0402|TWO_SIDED|95.0|-0.59|-0.01|||ANCOVA|||Change at Week 4: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.||-0.01|-0.59|0.0402
70866880|NCT02609828|141220098|SUPERIORITY||Difference in LS mean|-0.33|STANDARD_ERROR_OF_MEAN|0.17||0.0637|TWO_SIDED|95.0|-0.67|0.02|||ANCOVA|||Change at Week 8: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.||0.02|-0.67|0.0637
70866881|NCT02609828|141220098|SUPERIORITY||Difference in LS mean|-0.16|STANDARD_ERROR_OF_MEAN|0.18||0.3804|TWO_SIDED|95.0|-0.53|0.2|||ANCOVA|||Change at Week 16: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.||0.20|-0.53|0.3804
70866882|NCT02609828|141220098|SUPERIORITY||Difference in LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.5894|TWO_SIDED|95.0|-0.47|0.27|||ANCOVA|||Change at Week 24: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.||0.27|-0.47|0.5894
70866883|NCT02609828|141220099|SUPERIORITY||Odds Ratio (OR)|0.38||||0.2033|TWO_SIDED|95.0|0.09|1.69|||Regression, Logistic|||Week 2: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||1.69|0.09|0.2033
70866884|NCT02609828|141220099|SUPERIORITY||Odds Ratio (OR)|1.18||||0.7627|TWO_SIDED|95.0|0.41|3.41|||Regression, Logistic|||Week 4: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.41|0.41|0.7627
70866885|NCT02609828|141220099|SUPERIORITY||Odds Ratio (OR)|1.23||||0.6894|TWO_SIDED|95.0|0.44|3.43|||Regression, Logistic|||Week 8: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.43|0.44|0.6894
70866886|NCT02609828|141220099|SUPERIORITY||Odds Ratio (OR)|1.34||||0.5905|TWO_SIDED|95.0|0.47|3.83|||Regression, Logistic|||Week 16: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.83|0.47|0.5905
70866887|NCT02609828|141220099|SUPERIORITY||Odds Ratio (OR)|1.12||||0.8354|TWO_SIDED|95.0|0.38|3.35|||Regression, Logistic|||Week 24: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.35|0.38|0.8354
70866888|NCT02609828|141220102|SUPERIORITY||Difference in LS mean|-0.05|STANDARD_ERROR_OF_MEAN|0.22||0.8069|TWO_SIDED|95.0|-0.49|0.38|||Mixed Models Analysis|||Week 2 Frequency Composite Score: Mixed model for repeated measurements (MMRM) model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.38|-0.49|0.8069
70866889|NCT02609828|141220102|SUPERIORITY||Difference in LS mean|0.06|STANDARD_ERROR_OF_MEAN|0.17||0.7127|TWO_SIDED|95.0|-0.28|0.41|||Mixed Models Analysis|||Week 4 Frequency Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.41|-0.28|0.7127
70949764|NCT04092452|141401029|SUPERIORITY||Risk Difference (RD)|0.26|STANDARD_ERROR_OF_MEAN|0.439||0.7234|TWO_SIDED|90.0|-0.46|0.98||One-sided p-value|ANCOVA|||Week 8 Average Pain||0.98|-0.46|0.7234
70949765|NCT04092452|141401029|SUPERIORITY||Risk Difference (RD)|-0.02|STANDARD_ERROR_OF_MEAN|0.424||0.4773|TWO_SIDED|90.0|-0.72|0.67||One-sided p-value|ANCOVA|||Week 12 Average Pain||0.67|-0.72|0.4773
70866890|NCT02609828|141220102|SUPERIORITY||Difference in LS mean|-0.17|STANDARD_ERROR_OF_MEAN|0.2||0.3933|TWO_SIDED|95.0|-0.57|0.23|||Mixed Models Analysis|||Week 8 Frequency Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.23|-0.57|0.3933
70949766|NCT04092452|141401029|SUPERIORITY||Risk Difference (RD)|-0.57|STANDARD_ERROR_OF_MEAN|0.41||0.0818|TWO_SIDED|90.0|-1.25|0.1||One-sided p-value|ANCOVA|||Week 12 Average Pain||0.10|-1.25|0.0818
70949767|NCT04092452|141401029|SUPERIORITY||Risk Difference (RD)|0.15|STANDARD_ERROR_OF_MEAN|0.424||0.6397|TWO_SIDED|90.0|-0.55|0.85||One-sided p-value|ANCOVA|||Week 12 Average Pain||0.85|-0.55|0.6397
70866891|NCT02609828|141220102|SUPERIORITY||Difference in LS mean|-0.15|STANDARD_ERROR_OF_MEAN|0.28||0.5869|TWO_SIDED|95.0|-0.71|0.41|||Mixed Models Analysis|||Week 16 Frequency Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.41|-0.71|0.5869
70949768|NCT04092452|141401029|SUPERIORITY||Risk Difference (RD)|0.03|STANDARD_ERROR_OF_MEAN|0.428||0.5321|TWO_SIDED|90.0|-0.67|0.74||One-sided p-value|ANCOVA|||Week 16 Average Pain||0.74|-0.67|0.5321
70949769|NCT04092452|141401029|SUPERIORITY||Risk Difference (RD)|-0.89|STANDARD_ERROR_OF_MEAN|0.42||0.0167|TWO_SIDED|90.0|-1.59|-0.2||One-sided p-value|ANCOVA|||Week 16 Average Pain||-0.20|-1.59|0.0167
70949770|NCT04092452|141401029|SUPERIORITY||Risk Difference (RD)|-0.37|STANDARD_ERROR_OF_MEAN|0.434||0.1963|TWO_SIDED|90.0|-1.09|0.34||One-sided p-value|ANCOVA|||Week 16 Average Pain||0.34|-1.09|0.1963
70949771|NCT04092452|141401030|SUPERIORITY||Risk Difference (RD)|-2.2|STANDARD_ERROR_OF_MEAN|4.98|||TWO_SIDED|90.0|-10.3|6.0||||||Week 1||6.0|-10.3|
70949772|NCT04092452|141401030|SUPERIORITY||Risk Difference (RD)|2.0|STANDARD_ERROR_OF_MEAN|5.64|||TWO_SIDED|90.0|-7.3|11.3||||||Week 1||11.3|-7.3|
70949773|NCT04092452|141401030|SUPERIORITY||Risk Difference (RD)|6.8|STANDARD_ERROR_OF_MEAN|6.47|||TWO_SIDED|90.0|-3.9|17.4||||||Week 1||17.4|-3.9|
70949774|NCT04092452|141401030|SUPERIORITY||Risk Difference (RD)|10.7|STANDARD_ERROR_OF_MEAN|7.74|||TWO_SIDED|90.0|-2.0|23.4||||||Week 2||23.4|-2.0|
70949775|NCT04092452|141401030|SUPERIORITY||Risk Difference (RD)|7.6|STANDARD_ERROR_OF_MEAN|7.34|||TWO_SIDED|90.0|-4.5|19.7||||||Week 2||19.7|-4.5|
70949776|NCT04092452|141401030|SUPERIORITY||Risk Difference (RD)|7.5|STANDARD_ERROR_OF_MEAN|7.36|||TWO_SIDED|90.0|-4.6|19.6||||||Week 2||19.6|-4.6|
70949777|NCT04092452|141401030|SUPERIORITY||Risk Difference (RD)|7.4|STANDARD_ERROR_OF_MEAN|7.95|||TWO_SIDED|90.0|-5.7|20.5||||||Week 4||20.5|-5.7|
70949778|NCT04092452|141401030|SUPERIORITY||Risk Difference (RD)|15.1|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|90.0|1.4|28.7||||||Week 4||28.7|1.4|
70949779|NCT04092452|141401030|SUPERIORITY||Risk Difference (RD)|4.8|STANDARD_ERROR_OF_MEAN|7.74|||TWO_SIDED|90.0|-8.0|17.5||||||Week 4||17.5|-8.0|
71141465|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|1.45||||0.4932|TWO_SIDED|95.0|0.5|4.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.25|0.50|0.4932
71141466|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8504|TWO_SIDED|95.0|0.39|3.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.12|0.39|0.8504
71141467|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|3.07||||0.0759|TWO_SIDED|95.0|0.89|10.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.61|0.89|0.0759
71141468|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|3.69||||0.0477|TWO_SIDED|95.0|1.01|13.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||13.46|1.01|0.0477
71141469|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|2.47||||0.1448|TWO_SIDED|95.0|0.73|8.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.36|0.73|0.1448
71141470|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|5.54||||0.0173|TWO_SIDED|95.0|1.35|22.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||22.71|1.35|0.0173
71141471|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|2.57||||0.1101|TWO_SIDED|95.0|0.81|8.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.17|0.81|0.1101
70949780|NCT04092452|141401030|SUPERIORITY||Risk Difference (RD)|14.3|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|90.0|0.7|28.0||||||Week 6||28.0|0.7|
70949781|NCT04092452|141401030|SUPERIORITY||Risk Difference (RD)|10.9|STANDARD_ERROR_OF_MEAN|7.96|||TWO_SIDED|90.0|-2.2|24.0||||||Week 6||24.0|-2.2|
70949782|NCT04092452|141401030|SUPERIORITY||Risk Difference (RD)|10.6|STANDARD_ERROR_OF_MEAN|8.06|||TWO_SIDED|90.0|-2.6|23.9||||||Week 6||23.9|-2.6|
71141472|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|1.32||||0.6022|TWO_SIDED|95.0|0.46|3.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.78|0.46|0.6022
71141473|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|1.31||||0.6128|TWO_SIDED|95.0|0.46|3.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.73|0.46|0.6128
71141474|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|2.82||||0.1001|TWO_SIDED|95.0|0.82|9.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.68|0.82|0.1001
71141475|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|4.95||||0.0255|TWO_SIDED|95.0|1.22|20.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||20.12|1.22|0.0255
71141476|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|2.42||||0.1521|TWO_SIDED|95.0|0.72|8.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.10|0.72|0.1521
71141477|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|9.37||||0.0071|TWO_SIDED|95.0|1.84|47.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||47.69|1.84|0.0071
71141478|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|2.52||||0.115|TWO_SIDED|95.0|0.8|7.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.93|0.80|0.1150
71141479|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|1.14||||0.8101|TWO_SIDED|95.0|0.4|3.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.22|0.40|0.8101
70949783|NCT04092452|141401030|SUPERIORITY||Risk Difference (RD)|10.1|STANDARD_ERROR_OF_MEAN|8.38||0.1162|TWO_SIDED|90.0|-3.6|23.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||23.9|-3.6|0.1162
70949784|NCT04092452|141401030|SUPERIORITY||Risk Difference (RD)|13.1|STANDARD_ERROR_OF_MEAN|8.43||0.0642|TWO_SIDED|90.0|-0.8|27.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||27.0|-0.8|0.0642
70949785|NCT04092452|141401030|SUPERIORITY||Risk Difference (RD)|8.1|STANDARD_ERROR_OF_MEAN|8.36||0.1664|TWO_SIDED|90.0|-5.7|21.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||21.8|-5.7|0.1664
70949786|NCT04092452|141401030|SUPERIORITY||Risk Difference (RD)|7.2|STANDARD_ERROR_OF_MEAN|8.1||0.1882|TWO_SIDED|90.0|-6.1|20.5||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||20.5|-6.1|0.1882
70949787|NCT04092452|141401030|SUPERIORITY||Risk Difference (RD)|14.9|STANDARD_ERROR_OF_MEAN|8.43||0.0423|TWO_SIDED|90.0|1.1|28.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||28.8|1.1|0.0423
70949788|NCT04092452|141401030|SUPERIORITY||Risk Difference (RD)|3.3|STANDARD_ERROR_OF_MEAN|7.9||0.3396|TWO_SIDED|90.0|-9.7|16.3||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||16.3|-9.7|0.3396
70949789|NCT04092452|141401030|SUPERIORITY||Risk Difference (RD)|2.7|STANDARD_ERROR_OF_MEAN|7.35||0.3584|TWO_SIDED|90.0|-9.4|14.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16||14.8|-9.4|0.3584
70866892|NCT02609828|141220102|SUPERIORITY||Difference in LS mean|-0.42|STANDARD_ERROR_OF_MEAN|0.3||0.1814|TWO_SIDED|95.0|-1.05|0.21|||Mixed Models Analysis|||Week 24 Frequency Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.21|-1.05|0.1814
70866893|NCT02609828|141220102|SUPERIORITY||Difference in LS mean|0.16|STANDARD_ERROR_OF_MEAN|0.15||0.2822|TWO_SIDED|95.0|-0.14|0.46|||Mixed Models Analysis|||Week 2 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.46|-0.14|0.2822
70866894|NCT02609828|141220102|SUPERIORITY||Difference in LS mean|0.09|STANDARD_ERROR_OF_MEAN|0.16||0.5795|TWO_SIDED|95.0|-0.23|0.41|||Mixed Models Analysis|||Week 4 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.41|-0.23|0.5795
70866895|NCT02609828|141220102|SUPERIORITY||Difference in LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.16||0.5486|TWO_SIDED|95.0|-0.42|0.22|||Mixed Models Analysis|||Week 8 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.22|-0.42|0.5486
70866896|NCT02609828|141220102|SUPERIORITY||Difference in LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.22||0.3692|TWO_SIDED|95.0|-0.24|0.63|||Mixed Models Analysis|||Week 16 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.63|-0.24|0.3692
70866897|NCT02609828|141220102|SUPERIORITY||Difference in LS mean|0.17|STANDARD_ERROR_OF_MEAN|0.23||0.4724|TWO_SIDED|95.0|-0.3|0.63|||Mixed Models Analysis|||Week 24 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.63|-0.30|0.4724
70949790|NCT04092452|141401030|SUPERIORITY||Risk Difference (RD)|14.9|STANDARD_ERROR_OF_MEAN|8.17||0.0367|TWO_SIDED|90.0|1.5|28.3||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16||28.3|1.5|0.0367
71141480|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|1.49||||0.4663|TWO_SIDED|95.0|0.51|4.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.33|0.51|0.4663
71141481|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|3.8||||0.0453|TWO_SIDED|95.0|1.03|14.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||14.01|1.03|0.0453
71141482|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|3.36||||0.0659|TWO_SIDED|95.0|0.92|12.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||12.21|0.92|0.0659
71141483|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|1.83||||0.3117|TWO_SIDED|95.0|0.57|5.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.86|0.57|0.3117
71141484|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|6.02||||0.0129|TWO_SIDED|95.0|1.46|24.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||24.73|1.46|0.0129
71141485|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|4.12||||0.0303|TWO_SIDED|95.0|1.14|14.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||14.83|1.14|0.0303
71141486|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|1.94||||0.2772|TWO_SIDED|95.0|0.59|6.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.42|0.59|0.2772
71141487|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|0.96||||0.9432|TWO_SIDED|95.0|0.29|3.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.16|0.29|0.9432
71141488|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|2.08||||0.2577|TWO_SIDED|95.0|0.59|7.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.36|0.59|0.2577
71141489|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|2.55||||0.1496|TWO_SIDED|95.0|0.71|9.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.12|0.71|0.1496
70866898|NCT02609828|141220102|SUPERIORITY||Difference in LS mean|0.17|STANDARD_ERROR_OF_MEAN|0.23||0.477|TWO_SIDED|95.0|-0.3|0.64|||Mixed Models Analysis|||Week 2 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.64|-0.30|0.4770
70866899|NCT02609828|141220102|SUPERIORITY||Difference in LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.18||0.9791|TWO_SIDED|95.0|-0.38|0.37|||Mixed Models Analysis|||Week 4 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.37|-0.38|0.9791
70866900|NCT02609828|141220102|SUPERIORITY||Difference in LS mean|0.23|STANDARD_ERROR_OF_MEAN|0.25||0.3574|TWO_SIDED|95.0|-0.27|0.74|||Mixed Models Analysis|||Week 8 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.74|-0.27|0.3574
70866901|NCT02609828|141220102|SUPERIORITY||Difference in LS mean|0.17|STANDARD_ERROR_OF_MEAN|0.29||0.5607|TWO_SIDED|95.0|-0.77|0.42|||Mixed Models Analysis|||Week 16 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.42|-0.77|0.5607
70866902|NCT02609828|141220102|SUPERIORITY||Difference in LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.28||0.7143|TWO_SIDED|95.0|-0.68|0.47|||Mixed Models Analysis|||Week 24 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.47|-0.68|0.7143
70866903|NCT02609828|141220102|SUPERIORITY||Difference in LS mean|0.09|STANDARD_ERROR_OF_MEAN|0.18||0.6381|TWO_SIDED|95.0|-0.28|0.45|||Mixed Models Analysis|||Week 2 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.45|-0.28|0.6381
70949791|NCT04092452|141401030|SUPERIORITY||Risk Difference (RD)|5.2|STANDARD_ERROR_OF_MEAN|7.65||0.2486|TWO_SIDED|90.0|-7.4|17.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16||17.8|-7.4|0.2486
70949792|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.2|STANDARD_ERROR_OF_MEAN|0.295|||TWO_SIDED|90.0|-0.69|0.29||||||Week 1-HSS0101-Pain At It's Worst||0.29|-0.69|
70949793|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.48|STANDARD_ERROR_OF_MEAN|0.287|||TWO_SIDED|90.0|-0.96|-0.01||||||Week 1-HSS0101-Pain At It's Worst||-0.01|-0.96|
70949794|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.42|STANDARD_ERROR_OF_MEAN|0.295|||TWO_SIDED|90.0|-0.91|0.06||||||Week 1-HSS0101-Pain At It's Worst||0.06|-0.91|
70866904|NCT02609828|141220102|SUPERIORITY||Difference in LS mean|0.06|STANDARD_ERROR_OF_MEAN|0.15||0.7181|TWO_SIDED|95.0|-0.25|0.37|||Mixed Models Analysis|||Week 4 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.37|-0.25|0.7181
70866905|NCT02609828|141220102|SUPERIORITY||Difference in least square (LS) mean|-0.04|STANDARD_ERROR_OF_MEAN|0.17||0.8378|TWO_SIDED|95.0|-0.38|0.31|||Mixed Models Analysis|||Week 8 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.31|-0.38|0.8378
70866906|NCT02609828|141220102|SUPERIORITY||Difference in LS mean|-0.06|STANDARD_ERROR_OF_MEAN|0.23||0.795|TWO_SIDED|95.0|-0.52|0.4|||Mixed Models Analysis|||Week 16 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.40|-0.52|0.7950
70949795|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|0.392|||TWO_SIDED|90.0|-0.95|0.35||||||Week 2-HSS0101-Pain At It's Worst||0.35|-0.95|
70949796|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.71|STANDARD_ERROR_OF_MEAN|0.377|||TWO_SIDED|90.0|-1.33|-0.08||||||Week 2-HSS0101-Pain At It's Worst||-0.08|-1.33|
70949797|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.57|STANDARD_ERROR_OF_MEAN|0.391|||TWO_SIDED|90.0|-1.21|0.08||||||Week 2-HSS0101-Pain At It's Worst||0.08|-1.21|
70949798|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.26|STANDARD_ERROR_OF_MEAN|0.481|||TWO_SIDED|90.0|-0.54|1.05||||||Week 4-HSS0101-Pain At It's Worst||1.05|-0.54|
70949799|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.39|STANDARD_ERROR_OF_MEAN|0.458|||TWO_SIDED|90.0|-1.15|0.37||||||Week 4-HSS0101-Pain At It's Worst||0.37|-1.15|
70949800|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.06|STANDARD_ERROR_OF_MEAN|0.478|||TWO_SIDED|90.0|-0.85|0.73||||||Week 4-HSS0101-Pain At It's Worst||0.73|-0.85|
70949801|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.62|STANDARD_ERROR_OF_MEAN|0.524|||TWO_SIDED|90.0|-0.24|1.49||||||Week 6-HSS0101-Pain At It's Worst||1.49|-0.24|
70949802|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.19|STANDARD_ERROR_OF_MEAN|0.505|||TWO_SIDED|90.0|-1.03|0.64||||||Week 6-HSS0101-Pain At It's Worst||0.64|-1.03|
70949803|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.21|STANDARD_ERROR_OF_MEAN|0.526|||TWO_SIDED|90.0|-0.66|1.08||||||Week 6-HSS0101-Pain At It's Worst||1.08|-0.66|
70949804|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.24|STANDARD_ERROR_OF_MEAN|0.558|||TWO_SIDED|90.0|-0.69|1.16||||||Week 8-HSS0101-Pain At It's Worst||1.16|-0.69|
70866907|NCT02609828|141220102|SUPERIORITY||Difference in LS mean|-0.11|STANDARD_ERROR_OF_MEAN|0.25||0.6719|TWO_SIDED|95.0|-0.62|0.4|||Mixed Models Analysis|||Week 24 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.40|-0.62|0.6719
70866908|NCT03863197|141220134|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
70866909|NCT03863197|141220135|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
70866910|NCT03863197|141220136|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
70866911|NCT03863197|141220137|SUPERIORITY||||||<|0.01||||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
70866912|NCT03863197|141220138|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
70866913|NCT03863197|141220139|SUPERIORITY||||||<|0.01||||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
70866914|NCT03863197|141220143|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
70866915|NCT03863197|141220144|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
70866916|NCT05981391|141220145|SUPERIORITY|||||||0.01||||||Adjusted for multiple comparisons.|t-test, 2 sided|||||||0.01
70866917|NCT02498132|141220146|OTHER|A generalized estimating equation (GEE) model assuming a normal distribution, identity link function, and exchangeable correlation matrix was used to examine the interaction between time and treatment condition on BDI-II depressive symptoms adjusting for the main effects of baseline depressive symptoms, time, and treatment condition.|||||<|0.05|||||||Chi-squared|||||||<.05
70866918|NCT01065597|141220159|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||t-test, 2 sided|This was a paired t-test.||||||0.001
70866919|NCT01065597|141220160|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|This was a paired t-test.||||||>0.05
70866920|NCT01065597|141220162|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
70866921|NCT05280782|141220167|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Systolic Blood Pressure values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Systolic Blood Pressure values were normal.|||
70866922|NCT05280782|141220167|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Diastolic Blood Pressure values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Diastolic Blood Pressure values were normal.|||
70866923|NCT05280782|141220168|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Heart Rate values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Heart Rate values were normal.|||
70866924|NCT05280782|141220169|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Respiratory Rate values. The values were categorized as Normal or Abnormal.||||||0.016||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.016
70866925|NCT05280782|141220170|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Temperature values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Temperature values were normal.|||
70949805|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.32|STANDARD_ERROR_OF_MEAN|0.539|||TWO_SIDED|90.0|-1.21|0.57||||||Week 8-HSS0101-Pain At It's Worst||0.57|-1.21|
70949806|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.44|STANDARD_ERROR_OF_MEAN|0.565|||TWO_SIDED|90.0|-0.49|1.38||||||Week 8-HSS0101-Pain At It's Worst||1.38|-0.49|
70949807|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.578|||TWO_SIDED|90.0|-0.79|1.12||||||Week 12-HSS0101-Pain At It's Worst||1.12|-0.79|
70949808|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.68|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|90.0|-1.59|0.23||||||Week 12-HSS0101-Pain At It's Worst||0.23|-1.59|
70949809|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.08|STANDARD_ERROR_OF_MEAN|0.576|||TWO_SIDED|90.0|-0.88|1.03||||||Week 12-HSS0101-Pain At It's Worst||1.03|-0.88|
70949810|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.08|STANDARD_ERROR_OF_MEAN|0.631|||TWO_SIDED|90.0|-0.96|1.13||||||Week 16-HSS0101-Pain At It's Worst||1.13|-0.96|
70949811|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-1.25|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-2.24|-0.25||||||Week 16-HSS0101-Pain At It's Worst||-0.25|-2.24|
70949812|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.91|STANDARD_ERROR_OF_MEAN|0.628|||TWO_SIDED|90.0|-1.95|0.13||||||Week 16-HSS0101-Pain At It's Worst||0.13|-1.95|
70866926|NCT05280782|141220171|EQUIVALENCE|A McNemar test was performed between baseline and post-injection EKG. The outcomes were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the EKGs were normal.|||
70949813|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.01|STANDARD_ERROR_OF_MEAN|0.286|||TWO_SIDED|90.0|-0.47|0.48||||||Week 1-HSS0102-Tenderness At It's Worst||0.48|-0.47|
70949814|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.28|STANDARD_ERROR_OF_MEAN|0.278|||TWO_SIDED|90.0|-0.75|0.18||||||Week 1-HSS0102-Tenderness At It's Worst||0.18|-0.75|
70866927|NCT05280782|141220172|EQUIVALENCE|A McNemar test was performed between baseline and post-injection EKG. The outcomes were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the EKGs were normal.|||
71141490|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|2.05||||0.2874|TWO_SIDED|95.0|0.55|7.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.67|0.55|0.2874
71141491|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|2.26||||0.1981|TWO_SIDED|95.0|0.65|7.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.78|0.65|0.1981
71141492|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|3.35||||0.0531|TWO_SIDED|95.0|0.98|11.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||11.43|0.98|0.0531
70866928|NCT05280782|141220173|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Sodium values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Sodium values were normal.|||
71141493|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|0.72||||0.5858|TWO_SIDED|95.0|0.22|2.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.35|0.22|0.5858
71141494|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|0.68||||0.5122|TWO_SIDED|95.0|0.21|2.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.16|0.21|0.5122
71141495|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|0.55||||0.3415|TWO_SIDED|95.0|0.16|1.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.89|0.16|0.3415
71141496|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|0.87||||0.8263|TWO_SIDED|95.0|0.25|2.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.98|0.25|0.8263
71141497|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|0.86||||0.8085|TWO_SIDED|95.0|0.24|3.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.03|0.24|0.8085
71141498|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|1.3||||0.6745|TWO_SIDED|95.0|0.38|4.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.43|0.38|0.6745
71141499|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9019|TWO_SIDED|95.0|0.34|3.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.45|0.34|0.9019
71141500|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|0.62||||0.4425|TWO_SIDED|95.0|0.18|2.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.10|0.18|0.4425
71141501|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|0.54||||0.3106|TWO_SIDED|95.0|0.17|1.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.77|0.17|0.3106
71141502|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|0.32||||0.0912|TWO_SIDED|95.0|0.08|1.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.20|0.08|0.0912
71141503|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|0.7||||0.5681|TWO_SIDED|95.0|0.2|2.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.41|0.20|0.5681
70866929|NCT05280782|141220173|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Potassium values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Potassium values were normal.|||
70949815|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.31|STANDARD_ERROR_OF_MEAN|0.286|||TWO_SIDED|90.0|-0.78|0.17||||||Week 1-HSS0102-Tenderness At It's Worst||0.17|-0.78|
70949816|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.22|STANDARD_ERROR_OF_MEAN|0.361|||TWO_SIDED|90.0|-0.81|0.38||||||Week 2-HSS0102-Tenderness At It's Worst||0.38|-0.81|
70866930|NCT05280782|141220173|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Chloride values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Chloride values were normal.|||
70866931|NCT05280782|141220173|EQUIVALENCE|A McNemar test was performed between baseline and post-injection CO2 values. The values were categorized as Normal or Abnormal.||||||0.219||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.219
70866932|NCT05280782|141220174|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Glucose values. The values were categorized as Normal or Abnormal.||||||0.375||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.375
70866933|NCT05280782|141220174|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Calcium values. The values were categorized as Normal or Abnormal.||||||0.375||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.375
70866934|NCT05280782|141220174|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Creatinine values. The values were categorized as Normal or Abnormal.||||||0.453||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.453
70866935|NCT05280782|141220174|EQUIVALENCE|A McNemar test was performed between baseline and post-injection BUN values. The values were categorized as Normal or Abnormal.||||||0.125||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.125
70866936|NCT05280782|141220174|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Total Bilirubin values. The values were categorized as Normal or Abnormal.||||||0.219||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.219
70949817|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|0.347|||TWO_SIDED|90.0|-0.97|0.18||||||Week 2-HSS0102-Tenderness At It's Worst||0.18|-0.97|
70949818|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.46|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-1.05|0.14||||||Week 2-HSS0102-Tenderness At It's Worst||0.14|-1.05|
70949819|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.22|STANDARD_ERROR_OF_MEAN|0.471|||TWO_SIDED|90.0|-0.56|1.0||||||Week 4-HSS0102-Tenderness At It's Worst||1.00|-0.56|
70949820|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.25|STANDARD_ERROR_OF_MEAN|0.448|||TWO_SIDED|90.0|-0.99|0.49||||||Week 4-HSS0102-Tenderness At It's Worst||0.49|-0.99|
70949821|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.11|STANDARD_ERROR_OF_MEAN|0.468|||TWO_SIDED|90.0|-0.88|0.67||||||Week 4-HSS0102-Tenderness At It's Worst||0.67|-0.88|
70949822|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.48|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|90.0|-0.38|1.34||||||Week 6-HSS0102-Tenderness At It's Worst||1.34|-0.38|
70949823|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.23|STANDARD_ERROR_OF_MEAN|0.501|||TWO_SIDED|90.0|-1.06|0.6||||||Week 6-HSS0102-Tenderness At It's Worst||0.60|-1.06|
70949824|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.01|STANDARD_ERROR_OF_MEAN|0.523|||TWO_SIDED|90.0|-0.86|0.87||||||Week 6-HSS0102-Tenderness At It's Worst||0.87|-0.86|
70949825|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.542|||TWO_SIDED|90.0|-0.81|0.99||||||Week 8-HSS0102-Tenderness At It's Worst||0.99|-0.81|
70949826|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.25|STANDARD_ERROR_OF_MEAN|0.523|||TWO_SIDED|90.0|-1.11|0.62||||||Week 8-HSS0102-Tenderness At It's Worst||0.62|-1.11|
70949827|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.35|STANDARD_ERROR_OF_MEAN|0.549|||TWO_SIDED|90.0|-0.56|1.25||||||Week 8-HSS0102-Tenderness At It's Worst||1.25|-0.56|
70949828|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.554|||TWO_SIDED|90.0|-0.87|0.97||||||Week 12-HSS0102-Tenderness At It's Worst||0.97|-0.87|
70949829|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.49|STANDARD_ERROR_OF_MEAN|0.527|||TWO_SIDED|90.0|-1.36|0.38||||||Week 12-HSS0102-Tenderness At It's Worst||0.38|-1.36|
70949830|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.02|STANDARD_ERROR_OF_MEAN|0.552|||TWO_SIDED|90.0|-0.9|0.93||||||Week 12-HSS0102-Tenderness At It's Worst||0.93|-0.90|
70949831|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.04|STANDARD_ERROR_OF_MEAN|0.606|||TWO_SIDED|90.0|-0.96|1.04||||||Week 16-HSS0102-Tenderness At It's Worst||1.04|-0.96|
70949832|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-1.24|STANDARD_ERROR_OF_MEAN|0.577|||TWO_SIDED|90.0|-2.19|-0.29||||||Week 16-HSS0102-Tenderness At It's Worst||-0.29|-2.19|
70949833|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-1.11|STANDARD_ERROR_OF_MEAN|0.603|||TWO_SIDED|90.0|-2.11|-0.11||||||Week 16-HSS0102-Tenderness At It's Worst||-0.11|-2.11|
70949834|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.284|||TWO_SIDED|90.0|-0.57|0.37||||||Week 1-HSS0103-Swelling At It's Worst||0.37|-0.57|
70949835|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.23|STANDARD_ERROR_OF_MEAN|0.278|||TWO_SIDED|90.0|-0.69|0.22||||||Week 1-HSS0103-Swelling At It's Worst||0.22|-0.69|
70866937|NCT05280782|141220175|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Total Protein values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Total Protein values were normal.|||
70949836|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.47|STANDARD_ERROR_OF_MEAN|0.285|||TWO_SIDED|90.0|-0.94|0.01||||||Week 1-HSS0103-Swelling At It's Worst||0.01|-0.94|
70949837|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.24|STANDARD_ERROR_OF_MEAN|0.357|||TWO_SIDED|90.0|-0.83|0.35||||||Week 2-HSS0103-Swelling At It's Worst||0.35|-0.83|
70949838|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.46|STANDARD_ERROR_OF_MEAN|0.345|||TWO_SIDED|90.0|-1.03|0.11||||||Week 2-HSS0103-Swelling At It's Worst||0.11|-1.03|
70949839|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|0.357|||TWO_SIDED|90.0|-0.99|0.19||||||Week 2-HSS0103-Swelling At It's Worst||0.19|-0.99|
70949840|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.446|||TWO_SIDED|90.0|-0.58|0.9||||||Week 4-HSS0103-Swelling At It's Worst||0.90|-0.58|
70949841|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.17|STANDARD_ERROR_OF_MEAN|0.424|||TWO_SIDED|90.0|-0.87|0.53||||||Week 4-HSS0103-Swelling At It's Worst||0.53|-0.87|
70949842|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.443|||TWO_SIDED|90.0|-0.65|0.82||||||Week 4-HSS0103-Swelling At It's Worst||0.82|-0.65|
70949843|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.7|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|90.0|-0.15|1.54||||||Week 6-HSS0103-Swelling At It's Worst||1.54|-0.15|
70949844|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.02|STANDARD_ERROR_OF_MEAN|0.493|||TWO_SIDED|90.0|-0.83|0.8||||||Week 6-HSS0103-Swelling At It's Worst||0.80|-0.83|
70949845|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.23|STANDARD_ERROR_OF_MEAN|0.513|||TWO_SIDED|90.0|-0.62|1.08||||||Week 6-HSS0103-Swelling At It's Worst||1.08|-0.62|
70949846|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.29|STANDARD_ERROR_OF_MEAN|0.507|||TWO_SIDED|90.0|-0.55|1.13||||||Week 8-HSS0103-Swelling At It's Worst||1.13|-0.55|
70949847|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|0.489|||TWO_SIDED|90.0|-0.81|0.81||||||Week 8-HSS0103-Swelling At It's Worst||0.81|-0.81|
70949848|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.5|STANDARD_ERROR_OF_MEAN|0.514|||TWO_SIDED|90.0|-0.35|1.35||||||Week 8-HSS0103-Swelling At It's Worst||1.35|-0.35|
70949849|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.07|STANDARD_ERROR_OF_MEAN|0.532|||TWO_SIDED|90.0|-0.81|0.95||||||Week 12-HSS0103-Swelling At It's Worst||0.95|-0.81|
70949850|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.47|STANDARD_ERROR_OF_MEAN|0.505|||TWO_SIDED|90.0|-1.3|0.37||||||Week 12-HSS0103-Swelling At It's Worst||0.37|-1.30|
70949851|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.04|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-0.92|0.84||||||Week 12-HSS0103-Swelling At It's Worst||0.84|-0.92|
70949852|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.23|STANDARD_ERROR_OF_MEAN|0.589|||TWO_SIDED|90.0|-0.75|1.2||||||Week 16-HSS0103-Swelling At It's Worst||1.20|-0.75|
70949853|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-1.06|STANDARD_ERROR_OF_MEAN|0.561|||TWO_SIDED|90.0|-1.99|-0.13||||||Week 16-HSS0103-Swelling At It's Worst||-0.13|-1.99|
70949854|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-1.02|STANDARD_ERROR_OF_MEAN|0.586|||TWO_SIDED|90.0|-1.99|-0.05||||||Week 16-HSS0103-Swelling At It's Worst||-0.05|-1.99|
70949855|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.262|||TWO_SIDED|90.0|-0.27|0.59||||||Week 1-HSS0104-Tiredness At It's Worst||0.59|-0.27|
70949856|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.57|STANDARD_ERROR_OF_MEAN|0.255|||TWO_SIDED|90.0|-0.99|-0.15||||||Week 1-HSS0104-Tiredness At It's Worst||-0.15|-0.99|
70866938|NCT05280782|141220175|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Albumin values. The values were categorized as Normal or Abnormal.||||||0.219||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.219
70866939|NCT05280782|141220176|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Alkaline Phosphatase values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Alkaline Phosphatase values were normal.|||
70866940|NCT05280782|141220176|EQUIVALENCE|A McNemar test was performed between baseline and post-injection ALT values. The values were categorized as Normal or Abnormal.||||||0.219||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.219
70866941|NCT05280782|141220176|EQUIVALENCE|A McNemar test was performed between baseline and post-injection AST values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the AST values were normal.|||
70866942|NCT05280782|141220177|EQUIVALENCE|A McNemar test was performed between baseline and post-injection WBC values. The values were categorized as Normal or Abnormal.||||||0.687||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.687
70866943|NCT05280782|141220178|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Hemoglobin values. The values were categorized as Normal or Abnormal.||||||0.375||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.375
70949857|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.262|||TWO_SIDED|90.0|-0.35|0.52||||||Week 1-HSS0104-Tiredness At It's Worst||0.52|-0.35|
70866944|NCT05280782|141220179|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Hematocrit values. The values were categorized as Normal or Abnormal.||||||1||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||1.000
70866945|NCT05280782|141220180|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Platelets values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Platelets values were normal.|||
70866946|NCT05280782|141220181|EQUIVALENCE|A McNemar test was performed between baseline and post-injection RBC values. The values were categorized as Normal or Abnormal.||||||0.375||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.375
70866947|NCT05280782|141220182|EQUIVALENCE|A McNemar test was performed between baseline and post-injection MCV values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the MCV values were normal.|||
70866948|NCT02905149|141220195|SUPERIORITY||Median Difference (Final Values)|9.0|||<|0.05|TWO_SIDED|95.0|4.0|14.5||Not adjusted for multiple comparison|Wilcoxon (Mann-Whitney)||Generalized Hodges-Lehmann median difference is used. These are robust to the possibility that the population distributions in the two groups are different in ways other than location. It may not represent the raw median difference.|||14.5|4|< 0.05
70866949|NCT03285984|141220199|SUPERIORITY||Mean Difference (Net)|-0.21|||<|0.0001|TWO_SIDED|95.0|-0.27|-0.15||From ANCOVA model with factors for treatment group, period and subject (random effect), and subject-level baseline and period-level baseline|ANCOVA||Difference is first named treatment minus second-named treatment such that a negative difference favors the first named treatment|||-0.15|-0.27|<.0001
70866950|NCT02761733|141220203|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3652||||0.0679|TWO_SIDED|95.0|-6.9559|0.2255||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 173|||.2255|-6.9559|.0679
70866951|NCT02761733|141220203|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.882||||0.0999|TWO_SIDED|95.0|-6.2957|0.5317||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 165|||0.5317|-6.2957|.0999
70949858|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.06|STANDARD_ERROR_OF_MEAN|0.357|||TWO_SIDED|90.0|-0.54|0.65||||||Week 2-HSS0104-Tiredness At It's Worst||0.65|-0.54|
70866952|NCT02761733|141220203|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0139||||0.5588|TWO_SIDED|95.0|-4.4957|2.3779||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 148|||2.3779|-4.4957|.5588
70866953|NCT02761733|141220203|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2798||||0.8532|TWO_SIDED|95.0|-2.6771|3.2367||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 136|||3.2367|-2.6771|.8532
70866954|NCT02761733|141220204|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.4524||||0.0988|TWO_SIDED|95.0|-7.5302|0.6254||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 180|||0.6254|-7.5302|.0988
70866955|NCT02761733|141220204|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3087||||0.876|TWO_SIDED|95.0|-4.1799|3.5625||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 166|||3.5625|-4.1799|.8760
70866956|NCT02761733|141220204|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.541||||0.1878|TWO_SIDED|95.0|-1.2234|6.3054||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 153|||6.3054|-1.2234|.1878
70866957|NCT02761733|141220204|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6237||||0.333|TWO_SIDED|95.0|-4.9|1.6526||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 143|||1.6526|-4.9000|.3330
70866958|NCT02761733|141220205|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9284||||0.6588|TWO_SIDED|95.0|-10.4728|6.616||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 175|||6.6160|-10.4728|.6588
70949859|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.44|STANDARD_ERROR_OF_MEAN|0.344|||TWO_SIDED|90.0|-1.01|0.13||||||Week 2-HSS0104-Tiredness At It's Worst||0.13|-1.01|
70949860|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.26|STANDARD_ERROR_OF_MEAN|0.356|||TWO_SIDED|90.0|-0.33|0.85||||||Week 2-HSS0104-Tiredness At It's Worst||0.85|-0.33|
70949861|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.12|STANDARD_ERROR_OF_MEAN|0.434|||TWO_SIDED|90.0|-0.83|0.6||||||Week 4-HSS0104-Tiredness At It's Worst||0.60|-0.83|
70949862|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.81|STANDARD_ERROR_OF_MEAN|0.414|||TWO_SIDED|90.0|-1.49|-0.12||||||Week 4-HSS0104-Tiredness At It's Worst||-0.12|-1.49|
70949863|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.14|STANDARD_ERROR_OF_MEAN|0.431|||TWO_SIDED|90.0|-0.86|0.57||||||Week 4-HSS0104-Tiredness At It's Worst||0.57|-0.86|
70949864|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.04|STANDARD_ERROR_OF_MEAN|0.483|||TWO_SIDED|90.0|-0.76|0.84||||||Week 6-HSS0104-Tiredness At It's Worst||0.84|-0.76|
70949865|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.52|STANDARD_ERROR_OF_MEAN|0.466|||TWO_SIDED|90.0|-1.29|0.26||||||Week 6-HSS0104-Tiredness At It's Worst||0.26|-1.29|
70949866|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.485|||TWO_SIDED|90.0|-0.68|0.92||||||Week 6-HSS0104-Tiredness At It's Worst||0.92|-0.68|
71141504|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|0.58||||0.4261|TWO_SIDED|95.0|0.15|2.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.21|0.15|0.4261
71141505|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|0.82||||0.7514|TWO_SIDED|95.0|0.24|2.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.82|0.24|0.7514
71141506|NCT03192176|141778535|SUPERIORITY||Odds Ratio (OR)|0.52||||0.2712|TWO_SIDED|95.0|0.16|1.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.67|0.16|0.2712
71141507|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|4.89||||0.0103|TWO_SIDED|95.0|1.46|16.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.40|1.46|0.0103
71141508|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|7.19||||0.0011|TWO_SIDED|95.0|2.2|23.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||23.48|2.20|0.0011
70866959|NCT02761733|141220205|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.3959||||0.2633|TWO_SIDED|95.0|-2.2237|11.0155||Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Mixed Models Analysis|Satterthwaite adjusted df = 169||a priori test||11.0155|-2.2237|.2633
70866960|NCT02761733|141220205|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.9703||||0.0343|TWO_SIDED|95.0|-17.2107|-0.7299||Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Mixed Models Analysis|Satterthwaite adjusted df = 166|Satterthwaite adjusted df = 166|a priori test||-0.7299|-17.2107|.0343
70949867|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.17|STANDARD_ERROR_OF_MEAN|0.483|||TWO_SIDED|90.0|-0.96|0.63||||||Week 8-HSS0104-Tiredness At It's Worst||0.63|-0.96|
70949868|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.53|STANDARD_ERROR_OF_MEAN|0.466|||TWO_SIDED|90.0|-1.31|0.24||||||Week 8-HSS0104-Tiredness At It's Worst||0.24|-1.31|
70949869|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.11|STANDARD_ERROR_OF_MEAN|0.488|||TWO_SIDED|90.0|-0.69|0.92||||||Week 8-HSS0104-Tiredness At It's Worst||0.92|-0.69|
70949870|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.34|STANDARD_ERROR_OF_MEAN|0.527|||TWO_SIDED|90.0|-1.21|0.53||||||Week 12-HSS0104-Tiredness At It's Worst||0.53|-1.21|
70949871|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.81|STANDARD_ERROR_OF_MEAN|0.503|||TWO_SIDED|90.0|-1.64|0.02||||||Week 12-HSS0104-Tiredness At It's Worst||0.02|-1.64|
70949872|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.15|STANDARD_ERROR_OF_MEAN|0.527|||TWO_SIDED|90.0|-0.72|1.02||||||Week 12-HSS0104-Tiredness At It's Worst||1.02|-0.72|
71141509|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|11.06|||<|0.0001|TWO_SIDED|95.0|3.41|35.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||35.86|3.41|<0.0001
71141510|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|10.48||||0.0001|TWO_SIDED|95.0|3.18|34.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||34.55|3.18|0.0001
71141511|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|2.46||||0.1571|TWO_SIDED|95.0|0.71|8.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||8.55|0.71|0.1571
71141512|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|7.14||||0.001|TWO_SIDED|95.0|2.21|23.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||23.04|2.21|0.0010
71141513|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|7.35||||0.0008|TWO_SIDED|95.0|2.29|23.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||23.61|2.29|0.0008
71141514|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|2.78||||0.0342|TWO_SIDED|95.0|1.08|7.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.18|1.08|0.0342
71141515|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|2.98||||0.0231|TWO_SIDED|95.0|1.16|7.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.66|1.16|0.0231
70866961|NCT02761733|141220205|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.7297||||0.3126|TWO_SIDED|95.0|-3.4864|10.9458||Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Mixed Models Analysis||Satterthwaite adjusted df = 163|a priori test||10.9458|-3.4864|.3126
70866962|NCT02761733|141220206|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1241||||0.584|TWO_SIDED|95.0|-0.5675|0.3193||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 142|||.3193|-.5675|.5840
70866963|NCT02761733|141220206|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2642||||0.2404|TWO_SIDED|95.0|-0.1754|0.7038||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 184|||.7038|-.1754|.2404
70949873|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.22|STANDARD_ERROR_OF_MEAN|0.559|||TWO_SIDED|90.0|-0.7|1.15||||||Week 16-HSS0104-Tiredness At It's Worst||1.15|-0.70|
70866964|NCT02761733|141220206|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3192||||0.1074|TWO_SIDED|95.0|-0.0667|0.7051||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 129|||.7051|-.0667|.1074
70866965|NCT02761733|141220206|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0576||||0.7677|TWO_SIDED|95.0|-0.3238|0.439||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 131|||.4390|-.3238|.7677
70949874|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.56|STANDARD_ERROR_OF_MEAN|0.532|||TWO_SIDED|90.0|-1.44|0.32||||||Week 16-HSS0104-Tiredness At It's Worst||0.32|-1.44|
70949875|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.557|||TWO_SIDED|90.0|-0.83|1.01||||||Week 16-HSS0104-Tiredness At It's Worst||1.01|-0.83|
71141516|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|4.12||||0.0032|TWO_SIDED|95.0|1.6|10.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.55|1.60|0.0032
71141517|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|3.89||||0.0059|TWO_SIDED|95.0|1.48|10.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.22|1.48|0.0059
71141518|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|1.76||||0.2471|TWO_SIDED|95.0|0.68|4.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||4.59|0.68|0.2471
71141519|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|2.66||||0.0381|TWO_SIDED|95.0|1.05|6.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.70|1.05|0.0381
71141520|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|3.34||||0.0113|TWO_SIDED|95.0|1.31|8.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.48|1.31|0.0113
71141521|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|2.56||||0.0486|TWO_SIDED|95.0|1.01|6.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.52|1.01|0.0486
71141522|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|2.71||||0.035|TWO_SIDED|95.0|1.07|6.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.87|1.07|0.0350
71141523|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|4.24||||0.0027|TWO_SIDED|95.0|1.65|10.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.90|1.65|0.0027
71141524|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|4.68||||0.002|TWO_SIDED|95.0|1.76|12.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||12.47|1.76|0.0020
71141525|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0686|TWO_SIDED|95.0|0.94|6.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.19|0.94|0.0686
71141526|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|4.02||||0.0034|TWO_SIDED|95.0|1.58|10.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.21|1.58|0.0034
71141527|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0222|TWO_SIDED|95.0|1.16|7.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.22|1.16|0.0222
71141528|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|2.28||||0.0876|TWO_SIDED|95.0|0.89|5.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.84|0.89|0.0876
71141529|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|2.72||||0.0345|TWO_SIDED|95.0|1.08|6.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.88|1.08|0.0345
70949876|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.264|||TWO_SIDED|90.0|-0.39|0.49||||||Week 1-HSS0105-Bothered By Appearance HS Lesion||0.49|-0.39|
70866966|NCT02761733|141220207|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.026||||0.9046|TWO_SIDED|95.0|-0.4507|0.3987||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 182|||.3987|-.4507|.9046
70866967|NCT02761733|141220207|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2258||||0.2518|TWO_SIDED|95.0|-0.1591|0.6107||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 173|||.6107|-.1591|.2518
70949877|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.32|STANDARD_ERROR_OF_MEAN|0.257|||TWO_SIDED|90.0|-0.75|0.1||||||Week 1-HSS0105-Bothered By Appearance HS Lesion||0.10|-0.75|
71141530|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|2.76||||0.0319|TWO_SIDED|95.0|1.09|6.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.99|1.09|0.0319
70866968|NCT02761733|141220207|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.437||||0.0338|TWO_SIDED|95.0|-0.837|-0.037||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 165|||-.0370|-.8370|.0338
70866969|NCT02761733|141220207|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2564||||0.1555|TWO_SIDED|95.0|-0.6086|0.0958||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 157|||.0958|-.6086|.1555
70866970|NCT02761733|141220208|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2967||||0.0283|TWO_SIDED|95.0|-0.5599|-0.0335||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 213|||-.0335|-.5599|.0283
70866971|NCT02761733|141220208|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0401||||0.7407|TWO_SIDED|95.0|-0.1969|0.2771||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 194|||.2771|-.1969|.7407
70866972|NCT02761733|141220208|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2338||||0.0619|TWO_SIDED|95.0|-0.4778|0.0102||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 186|||.0102|-.4778|.0619
70866973|NCT02761733|141220208|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3793||||0.0009|TWO_SIDED|95.0|-0.599|-0.1596||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 172|||-.1596|-.5990|.0009
71141531|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|5.27||||0.0013|TWO_SIDED|95.0|1.92|14.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||14.47|1.92|0.0013
71141532|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|1.91||||0.1751|TWO_SIDED|95.0|0.75|4.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||4.87|0.75|0.1751
70866974|NCT03993132|141220244|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.91|1.11|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.11|0.91|
70866975|NCT03993132|141220245|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|1.01|1.13|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.13|1.01|
70866976|NCT03993132|141220246|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.84|1.08|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.08|0.84|
70866977|NCT03993132|141220247|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.96|1.11|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.11|0.96|
70866978|NCT03993132|141220248|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.61|0.83|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||0.83|0.61|
70866979|NCT03993132|141220249|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.76|0.91|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||0.91|0.76|
70866980|NCT03993132|141220250|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.88|0.96|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||0.96|0.88|
70866981|NCT03993132|141220251|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.91|0.96|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||0.96|0.91|
71141533|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|4.46||||0.0019|TWO_SIDED|95.0|1.73|11.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||11.50|1.73|0.0019
71141534|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|2.79||||0.0284|TWO_SIDED|95.0|1.11|6.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.97|1.11|0.0284
71141535|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|1.72||||0.265|TWO_SIDED|95.0|0.66|4.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.45|0.66|0.2650
71141536|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|2.1||||0.1238|TWO_SIDED|95.0|0.82|5.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.38|0.82|0.1238
71141537|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|3.22||||0.0219|TWO_SIDED|95.0|1.18|8.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.74|1.18|0.0219
71141538|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|5.46||||0.0022|TWO_SIDED|95.0|1.84|16.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||16.16|1.84|0.0022
71141539|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|1.82||||0.223|TWO_SIDED|95.0|0.69|4.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.77|0.69|0.2230
71141540|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|5.05||||0.0018|TWO_SIDED|95.0|1.83|13.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||13.97|1.83|0.0018
71141541|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|3.17||||0.0205|TWO_SIDED|95.0|1.19|8.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.42|1.19|0.0205
71141542|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|1.44||||0.4628|TWO_SIDED|95.0|0.54|3.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.81|0.54|0.4628
71141543|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|1.51||||0.4015|TWO_SIDED|95.0|0.58|3.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.92|0.58|0.4015
71141544|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|5.39||||0.0031|TWO_SIDED|95.0|1.76|16.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||16.47|1.76|0.0031
71141545|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|4.15||||0.0115|TWO_SIDED|95.0|1.38|12.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||12.50|1.38|0.0115
71141546|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|1.81||||0.2513|TWO_SIDED|95.0|0.66|4.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||4.98|0.66|0.2513
71141547|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|3.94||||0.0099|TWO_SIDED|95.0|1.39|11.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||11.14|1.39|0.0099
71141548|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|3.19||||0.0242|TWO_SIDED|95.0|1.16|8.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||8.74|1.16|0.0242
71141549|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|2.07||||0.1518|TWO_SIDED|95.0|0.77|5.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.60|0.77|0.1518
71141550|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|1.95||||0.1811|TWO_SIDED|95.0|0.73|5.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.17|0.73|0.1811
70949878|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.02|STANDARD_ERROR_OF_MEAN|0.266|||TWO_SIDED|90.0|-0.46|0.42||||||Week 1-HSS0105-Bothered By Appearance HS Lesion||0.42|-0.46|
70949879|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.333|||TWO_SIDED|90.0|-0.65|0.45||||||Week 2-HSS0105-Bothered By Appearance HS Lesion||0.45|-0.65|
70949880|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.8|STANDARD_ERROR_OF_MEAN|0.321|||TWO_SIDED|90.0|-1.33|-0.27||||||Week 2-HSS0105-Bothered By Appearance HS Lesion||-0.27|-1.33|
70949881|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.36|STANDARD_ERROR_OF_MEAN|0.333|||TWO_SIDED|90.0|-0.91|0.19||||||Week 2-HSS0105-Bothered By Appearance HS Lesion||0.19|-0.91|
70949882|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.32|STANDARD_ERROR_OF_MEAN|0.411|||TWO_SIDED|90.0|-0.36|1.0||||||Week 4-HSS0105-Bothered By Appearance HS Lesion||1.00|-0.36|
70949883|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.94|STANDARD_ERROR_OF_MEAN|0.393|||TWO_SIDED|90.0|-1.59|-0.29||||||Week 4-HSS0105-Bothered By Appearance HS Lesion||-0.29|-1.59|
70866982|NCT03993132|141220252|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.88|0.96|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||0.96|0.88|
70866983|NCT03993132|141220253|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.91|0.96|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||0.96|0.91|
70866984|NCT03993132|141220254|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.83|1.18|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.18|0.83|
70866985|NCT03993132|141220255|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.97|1.16|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.16|0.97|
70866986|NCT03993132|141220256|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.72|1.06|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.06|0.72|
70866987|NCT03993132|141220257|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.88|1.1|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.10|0.88|
70866988|NCT02805972|141220263|SUPERIORITY|"The null hypothesis is that there would be no difference across the Naloxone and placebo conditions.~The alternative hypothesis is that the cortisol value would be higher in the Naloxone condition than in the placebo condition."|Mean Difference (Final Values)|1.26||||0.067|TWO_SIDED|95.0|0.98|1.61||If the Winsorized value is excluded from analyses altogether, the P value is .012|t-test, 2 sided|Cortisol was log transformed for the statistical test, and the reported mean difference was exponentiated back to the original units of nmol/L below.||We compared cortisol values at 55 minutes, within person, across conditions. We Winsorized one participant's values for the placebo visit where values were between 2-4x above the 99th percentile value in the data and then log-transformed the data.||1.61|0.98|.067
70949884|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.29|STANDARD_ERROR_OF_MEAN|0.411|||TWO_SIDED|90.0|-0.97|0.39||||||Week 4-HSS0105-Bothered By Appearance HS Lesion||0.39|-0.97|
70949885|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.55|STANDARD_ERROR_OF_MEAN|0.454|||TWO_SIDED|90.0|-0.2|1.3||||||Week 6-HSS0105-Bothered By Appearance HS Lesion||1.30|-0.20|
70949886|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.69|STANDARD_ERROR_OF_MEAN|0.439|||TWO_SIDED|90.0|-1.41|0.04||||||Week 6-HSS0105-Bothered By Appearance HS Lesion||0.04|-1.41|
70949887|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.456|||TWO_SIDED|90.0|-0.85|0.66||||||Week 6-HSS0105-Bothered By Appearance HS Lesion||0.66|-0.85|
70866989|NCT03576495|141220319|SUPERIORITY|"We conducted a superiority statistical test to assess if residents' knowledge improved after exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum on resident knowledge, resident knowledge was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups."|Mean Difference (Final Values)|2.6||||0.2422|TWO_SIDED|||||This p-value compares the average scores (in percent) of the residents' knowledge assessment at time period 2 between the Early Intervention and Delayed Intervention groups.|t-test, 2 sided|||||||0.2422
70866990|NCT03576495|141220320|SUPERIORITY||Difference between percentage|0.0||||1|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if residents' preparation for caring for culturally diverse patients improved after exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum on resident preparedness assessed by the Cross-Cultural Care Survey, resident preparedness was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups."||||1.000
70866991|NCT03576495|141220321|SUPERIORITY||Percent difference|0.9||||0.6295|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if residents' self-assessed skills improved after exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum on resident skills, resident skills were compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups."||||0.6295
70949888|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.15|STANDARD_ERROR_OF_MEAN|0.491|||TWO_SIDED|90.0|-0.96|0.66||||||Week 8-HSS0105-Bothered By Appearance HS Lesion||0.66|-0.96|
70949889|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-1.11|STANDARD_ERROR_OF_MEAN|0.473|||TWO_SIDED|90.0|-1.89|-0.33||||||Week 8-HSS0105-Bothered By Appearance HS Lesion||-0.33|-1.89|
70949890|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|0.497|||TWO_SIDED|90.0|-1.13|0.52||||||Week 8-HSS0105-Bothered By Appearance HS Lesion||0.52|-1.13|
70949891|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.547|||TWO_SIDED|90.0|-0.86|0.95||||||Week 12-HSS0105-Bothered By Appearance HS Lesion||0.95|-0.86|
70949892|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.87|STANDARD_ERROR_OF_MEAN|0.523|||TWO_SIDED|90.0|-1.73|-0.01||||||Week 12-HSS0105-Bothered By Appearance HS Lesion||-0.01|-1.73|
70949893|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.547|||TWO_SIDED|90.0|-0.78|1.03||||||Week 12-HSS0105-Bothered By Appearance HS Lesion||1.03|-0.78|
70866992|NCT03576495|141220322|SUPERIORITY||Difference between percentage|2.5||||0.0199|TWO_SIDED||||||Fisher Exact|||"We conducted a superiority statistical test to assess if residents' beliefs improved after exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum on resident beliefs, beliefs were compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups."||||0.0199
70866993|NCT03576495|141220323|SUPERIORITY||difference in the percentage|2.2||||0.2665|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if residents' OSCE performance improved after exposure to the PACTS curriculum. OSCE performance was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in the percentage of residents designated mostly and a great deal on Limited English Proficiency and Informed Consent OSCE."||||0.2665
70949894|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|0.39|STANDARD_ERROR_OF_MEAN|0.602|||TWO_SIDED|90.0|-0.6|1.39||||||Week 16-HSS0105-Bothered By Appearance HS Lesion||1.39|-0.60|
70949895|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.95|STANDARD_ERROR_OF_MEAN|0.574|||TWO_SIDED|90.0|-1.9|0.0||||||Week 16-HSS0105-Bothered By Appearance HS Lesion||0.00|-1.90|
70866994|NCT03576495|141220323|SUPERIORITY||difference in the percentage|6.2||||0.0001|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if residents' OSCE performance improved after exposure to the PACTS curriculum. OSCE performance was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in the percentage of residents designated mostly and a great deal on Trust and Pain."||||0.0001
70866995|NCT03576495|141220324|SUPERIORITY||absolute difference between percentage|3.19||||0.5079|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if patient satisfaction improved after resident exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum, patient satisfaction was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in proportion of patients who reported agree and strongly agree for satisfaction as it relates to trust at time period 2."||||0.5079
70866996|NCT03576495|141220324|SUPERIORITY||absolute difference between percentage|1.92||||0.1571|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if patient satisfaction improved after resident exposure to the PACTS curriculum. For purposes of measuring an effect of the curriculum, patient satisfaction was compared at Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in proportion of patients who reported agree and strongly agree for satisfaction as it relates to limited English proficiency at period 2."||||0.1571
70866997|NCT03576495|141220324|SUPERIORITY||absolute difference between percentage|4.76||||0.0001|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if patient satisfaction improved after resident exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum, patient satisfaction was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in proportion of patients who reported agree and strongly agree for satisfaction as it relates to consent at time period 2."||||0.0001
70866998|NCT03576495|141220324|SUPERIORITY||absolute difference between percentage|0.19||||0.2956|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if patient satisfaction improved after resident exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum, patient satisfaction was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in proportion of patients who reported agree and strongly agree for satisfaction as it relates to pain at time period 2."||||0.2956
70949896|NCT04092452|141401036|SUPERIORITY||Risk Difference (RD)|-0.01|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-1.0|0.99||||||Week 16-HSS0105-Bothered By Appearance HS Lesion||0.99|-1.00|
70949897|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.2|STANDARD_ERROR_OF_MEAN|0.295|||TWO_SIDED|90.0|-0.69|0.29||||||Week 1-HSS0101-Pain At It's Worst||0.29|-0.69|
70949898|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.48|STANDARD_ERROR_OF_MEAN|0.287|||TWO_SIDED|90.0|-0.96|-0.01||||||Week 1-HSS0101-Pain At It's Worst||-0.01|-0.96|
70872209|NCT01727297|141229672|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.22|TWO_SIDED|95.0|0.45|1.2||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having COPD on a patient's risk of developing AF.|The null hypothesis was that Chronic obstructive pulmonary disease (COPD) did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.20|0.45|0.22
70949899|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.42|STANDARD_ERROR_OF_MEAN|0.295|||TWO_SIDED|90.0|-0.91|0.06||||||Week 1-HSS0101-Pain At It's Worst||0.06|-0.91|
70949900|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|0.392|||TWO_SIDED|90.0|-0.95|0.35||||||Week 2-HSS0101-Pain At It's Worst||0.35|-0.95|
70949901|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.71|STANDARD_ERROR_OF_MEAN|0.377|||TWO_SIDED|90.0|-1.33|-0.08||||||Week 2-HSS0101-Pain At It's Worst||-0.08|-1.33|
70949902|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.57|STANDARD_ERROR_OF_MEAN|0.391|||TWO_SIDED|90.0|-1.21|0.08||||||Week 2-HSS0101-Pain At It's Worst||0.08|-1.21|
70949903|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.26|STANDARD_ERROR_OF_MEAN|0.481|||TWO_SIDED|90.0|-0.54|1.05||||||Week 4-HSS0101-Pain At It's Worst||1.05|-0.54|
70949904|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.39|STANDARD_ERROR_OF_MEAN|0.458|||TWO_SIDED|90.0|-1.15|0.37||||||Week 4-HSS0101-Pain At It's Worst||0.37|-1.15|
70949905|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.06|STANDARD_ERROR_OF_MEAN|0.478|||TWO_SIDED|90.0|-0.85|0.73||||||Week 4-HSS0101-Pain At It's Worst||0.73|-0.85|
70949906|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.62|STANDARD_ERROR_OF_MEAN|0.524|||TWO_SIDED|90.0|-0.24|1.49||||||Week 6-HSS0101-Pain At It's Worst||1.49|-0.24|
70949907|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.19|STANDARD_ERROR_OF_MEAN|0.505|||TWO_SIDED|90.0|-1.03|0.64||||||Week 6-HSS0101-Pain At It's Worst||0.64|-1.03|
70949908|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.21|STANDARD_ERROR_OF_MEAN|0.526|||TWO_SIDED|90.0|-0.66|1.08||||||Week 6-HSS0101-Pain At It's Worst||1.08|-0.66|
70949909|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.24|STANDARD_ERROR_OF_MEAN|0.558|||TWO_SIDED|90.0|-0.69|1.16||||||Week 8-HSS0101-Pain At It's Worst||1.16|-0.69|
70949910|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.32|STANDARD_ERROR_OF_MEAN|0.539|||TWO_SIDED|90.0|-1.21|0.57||||||Week 8-HSS0101-Pain At It's Worst||0.57|-1.21|
70866999|NCT03576495|141220325|SUPERIORITY||Cox Proportional Hazard|5.31||||0.0028|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||We used Cox Proportional Hazard to assess time to discharge, with 5.31 days as the estimated value for the difference between the two groups.|"We conducted a superiority statistical test to assess if patients length of stay improved after resident exposure to the PACTS curriculum. Patient length of stay was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups to measure an effect of the PACTS intervention."||||0.0028
70867000|NCT02635776|141220327|SUPERIORITY||Risk Difference (RD)|63.2|||<|0.0001|TWO_SIDED|95.0|53.0|73.3|||Farrington-Manning test|||Treatment difference at 600 mg||73.3|53|<0.0001
70867001|NCT02635776|141220328|SUPERIORITY||Risk Difference (RD)|47.8|||<|0.0001|TWO_SIDED|95.0|38.0|57.7|||Farrington-Manning test|||Treatment difference at 1000 mg||57.7|38|<0.0001
70867002|NCT02635776|141220329|SUPERIORITY||Risk Difference (RD)|68.5|||<|0.0001|TWO_SIDED|95.0|58.6|78.5|||Farrington-Manning test|||Treatment difference at 300 mg||78.5|58.6|<0.0001
70867003|NCT02635776|141220330|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test (using equally spaced scores), stratified by region (North America, Europe)||Treatment difference in maximum severity||||<0.0001
70867004|NCT00788073|141220331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.05|||||||ANCOVA|||||||0.05
70867005|NCT00788073|141220332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.008||95.0|||||ANCOVA|||||||0.008
70867006|NCT00660673|141220349|OTHER||||||<|0.001|||||||One-sample t-test|||"Change from initial LCIG infusion to end of study in off time was assessed for significance using a 1-sample paired t test"||||<0.001
70867007|NCT00660673|141220349|OTHER|||||||0.433|||||||One-sample t-test|||"Change from Baseline to end of study in off time was assessed for significance using a 1-sample paired t-test."||||0.433
70949911|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.44|STANDARD_ERROR_OF_MEAN|0.565|||TWO_SIDED|90.0|-0.49|1.38||||||Week 8-HSS0101-Pain At It's Worst||1.38|-0.49|
70867008|NCT00660673|141220350|OTHER||||||<|0.001|||||||One-sample t-test|||"Change from initial LCIG infusion to end of study in on time without troublesome dyskinesia was assessed for significance using a 1-sample paired t-test."||||<0.001
70867009|NCT00660673|141220350|OTHER|||||||0.15|||||||One-sample t-test|||"Change from Baseline to end of study in on time without troublesome dyskinesia was assessed for significance using a 1-sample paired t test"||||0.150
70949912|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.578|||TWO_SIDED|90.0|-0.79|1.12||||||Week 12-HSS0101-Pain At It's Worst||1.12|-0.79|
70867010|NCT00660673|141220351|OTHER|||||||0.725|||||||One-sample t-test|||"Change from initial LCIG infusion to end of study in on time with troublesome dyskinesia was assessed for significance using a 1-sample paired t test"||||0.725
70867011|NCT00660673|141220351|OTHER|||||||0.019|||||||One-sample t-test|||"Change from Baseline to end of study in on time with troublesome dyskinesia was assessed for significance using a 1-sample paired t test"||||0.019
70949913|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.68|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|90.0|-1.59|0.23||||||Week 12-HSS0101-Pain At It's Worst||0.23|-1.59|
71141551|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|3.88||||0.015|TWO_SIDED|95.0|1.3|11.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||11.55|1.30|0.0150
70867012|NCT00579098|141220361|SUPERIORITY_OR_OTHER|||||||0.75||95.0||||A p-value of \< 0.05 was considered statistically significant.|Log Rank|||||||0.75
70867013|NCT00579098|141220362|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||A p-value of \< 0.05 was considered statistically significant.|Log Rank|||||||0.37
71141552|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0046|TWO_SIDED|95.0|1.67|16.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||16.68|1.67|0.0046
70949914|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.08|STANDARD_ERROR_OF_MEAN|0.576|||TWO_SIDED|90.0|-0.88|1.03||||||Week 12-HSS0101-Pain At It's Worst||1.03|-0.88|
70949915|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.08|STANDARD_ERROR_OF_MEAN|0.631|||TWO_SIDED|90.0|-0.96|1.13||||||Week 16-HSS0101-Pain At It's Worst||1.13|-0.96|
70949916|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-1.25|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-2.24|-0.25||||||Week 16-HSS0101-Pain At It's Worst||-0.25|-2.24|
70867014|NCT00579098|141220363|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||A p-value of \< 0.05 was considered statistically significant.|t-test, 2 sided|||||||0.11
70867015|NCT00579098|141220364|SUPERIORITY_OR_OTHER|||||||0.53||95.0||||Comparison between treatment groups. A p-value of \< 0.05 was considered statistically significant.|t-test, 2 sided|||||||0.53
70949917|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.91|STANDARD_ERROR_OF_MEAN|0.628|||TWO_SIDED|90.0|-1.95|0.13||||||Week 16-HSS0101-Pain At It's Worst||0.13|-1.95|
70949918|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.01|STANDARD_ERROR_OF_MEAN|0.286|||TWO_SIDED|90.0|-0.47|0.48||||||Week 1-HSS0102-Tenderness At It's Worst||0.48|-0.47|
70949919|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.28|STANDARD_ERROR_OF_MEAN|0.278|||TWO_SIDED|90.0|-0.75|0.18||||||Week 1-HSS0102-Tenderness At It's Worst||0.18|-0.75|
70949920|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.31|STANDARD_ERROR_OF_MEAN|0.286|||TWO_SIDED|90.0|-0.78|0.17||||||Week 1-HSS0102-Tenderness At It's Worst||0.17|-0.78|
70867016|NCT00579098|141220365|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A p-value of \< 0.05 was considered statistically significant.|t-test, 2 sided|||The change in total cholesterol was compared between treatment groups.||||<0.001
70867017|NCT00579098|141220365|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A p-value of \< 0.05 was considered statistically significant.|t-test, 2 sided|||The change in LDL cholesterol was compared between treatment groups.||||<0.001
70867018|NCT00579098|141220365|SUPERIORITY_OR_OTHER|||||||0.92||95.0||||A p-value of \< 0.05 was considered statistically significant.|t-test, 2 sided|||The change in HDL cholesterol was compared between treatment groups.||||0.92
70867019|NCT02197273|141220371|SUPERIORITY_OR_OTHER|||||||0.764|||||||Wilcoxon (Mann-Whitney)|||||||0.764
70949921|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.22|STANDARD_ERROR_OF_MEAN|0.361|||TWO_SIDED|90.0|-0.81|0.38||||||Week 2-HSS0102-Tenderness At It's Worst||0.38|-0.81|
70949922|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|0.347|||TWO_SIDED|90.0|-0.97|0.18||||||Week 2-HSS0102-Tenderness At It's Worst||0.18|-0.97|
70949923|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.46|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-1.05|0.14||||||Week 2-HSS0102-Tenderness At It's Worst||0.14|-1.05|
70949924|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.22|STANDARD_ERROR_OF_MEAN|0.471|||TWO_SIDED|90.0|-0.56|1.0||||||Week 4-HSS0102-Tenderness At It's Worst||1.00|-0.56|
70867020|NCT02197273|141220372|SUPERIORITY_OR_OTHER|||||||0.206|||||||Wilcoxon (Mann-Whitney)|||||||0.206
70867021|NCT02197273|141220373|SUPERIORITY_OR_OTHER||Fisher exact|0.486||||0.656|TWO_SIDED||||||Fisher Exact|||||||0.656
70867022|NCT03855228|141220402|SUPERIORITY|||||||0.36|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.36
70867023|NCT03855228|141220402|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
70949925|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.25|STANDARD_ERROR_OF_MEAN|0.448|||TWO_SIDED|90.0|-0.99|0.49||||||Week 4-HSS0102-Tenderness At It's Worst||0.49|-0.99|
70949926|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.11|STANDARD_ERROR_OF_MEAN|0.468|||TWO_SIDED|90.0|-0.88|0.67||||||Week 4-HSS0102-Tenderness At It's Worst||0.67|-0.88|
70867024|NCT03855228|141220402|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
70867025|NCT03855228|141220402|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
70867026|NCT03855228|141220402|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
70867027|NCT03855228|141220402|SUPERIORITY|||||||0.02|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.02
70867028|NCT03855228|141220403|SUPERIORITY|||||||0.35|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.35
70867029|NCT03855228|141220403|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
70867030|NCT03855228|141220403|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
70867031|NCT03855228|141220403|SUPERIORITY|||||||0.03|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.03
70949927|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.48|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|90.0|-0.38|1.34||||||Week 6-HSS0102-Tenderness At It's Worst||1.34|-0.38|
70949928|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.23|STANDARD_ERROR_OF_MEAN|0.501|||TWO_SIDED|90.0|-1.06|0.6||||||Week 6-HSS0102-Tenderness At It's Worst||0.60|-1.06|
70949929|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.01|STANDARD_ERROR_OF_MEAN|0.523|||TWO_SIDED|90.0|-0.86|0.87||||||Week 6-HSS0102-Tenderness At It's Worst||0.87|-0.86|
70949930|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.542|||TWO_SIDED|90.0|-0.81|0.99||||||Week 8-HSS0102-Tenderness At It's Worst||0.99|-0.81|
70949931|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.25|STANDARD_ERROR_OF_MEAN|0.523|||TWO_SIDED|90.0|-1.11|0.62||||||Week 8-HSS0102-Tenderness At It's Worst||0.62|-1.11|
70949932|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.35|STANDARD_ERROR_OF_MEAN|0.549|||TWO_SIDED|90.0|-0.56|1.25||||||Week 8-HSS0102-Tenderness At It's Worst||1.25|-0.56|
70949933|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.554|||TWO_SIDED|90.0|-0.87|0.97||||||Week 12-HSS0102-Tenderness At It's Worst||0.97|-0.87|
70949934|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.49|STANDARD_ERROR_OF_MEAN|0.527|||TWO_SIDED|90.0|-1.36|0.38||||||Week 12-HSS0102-Tenderness At It's Worst||0.38|-1.36|
70949935|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.02|STANDARD_ERROR_OF_MEAN|0.552|||TWO_SIDED|90.0|-0.9|0.93||||||Week 12-HSS0102-Tenderness At It's Worst||0.93|-0.90|
70949936|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.04|STANDARD_ERROR_OF_MEAN|0.606|||TWO_SIDED|90.0|-0.96|1.04||||||Week 16-HSS0102-Tenderness At It's Worst||1.04|-0.96|
70949937|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-1.24|STANDARD_ERROR_OF_MEAN|0.577|||TWO_SIDED|90.0|-2.19|-0.29||||||Week 16-HSS0102-Tenderness At It's Worst||-0.29|-2.19|
70949938|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-1.11|STANDARD_ERROR_OF_MEAN|0.603|||TWO_SIDED|90.0|-2.11|-0.11||||||Week 16-HSS0102-Tenderness At It's Worst||-0.11|-2.11|
70949939|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.284|||TWO_SIDED|90.0|-0.57|0.37||||||Week 1-HSS0103-Swelling At It's Worst||0.37|-0.57|
70867032|NCT03855228|141220403|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
70867033|NCT03855228|141220403|SUPERIORITY|||||||0.02|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.02
70867034|NCT03855228|141220404|SUPERIORITY|||||||0.77|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.77
70867035|NCT03855228|141220404|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
70867036|NCT03855228|141220404|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
70867037|NCT03855228|141220404|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
70949940|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.23|STANDARD_ERROR_OF_MEAN|0.278|||TWO_SIDED|90.0|-0.69|0.22||||||Week 1-HSS0103-Swelling At It's Worst||0.22|-0.69|
70867038|NCT03855228|141220404|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
70867039|NCT03855228|141220404|SUPERIORITY|||||||0.45|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.45
70867040|NCT03855228|141220405|SUPERIORITY|||||||0.99|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.99
70867041|NCT03855228|141220405|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
70867042|NCT03855228|141220405|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
70867043|NCT03855228|141220405|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
70949941|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.47|STANDARD_ERROR_OF_MEAN|0.285|||TWO_SIDED|90.0|-0.94|0.01||||||Week 1-HSS0103-Swelling At It's Worst||0.01|-0.94|
70949942|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.24|STANDARD_ERROR_OF_MEAN|0.357|||TWO_SIDED|90.0|-0.83|0.35||||||Week 2-HSS0103-Swelling At It's Worst||0.35|-0.83|
70867044|NCT03855228|141220405|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
70867045|NCT03855228|141220405|SUPERIORITY|||||||0.08|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.08
70867046|NCT03855228|141220406|SUPERIORITY|||||||0.85|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.85
70867047|NCT03855228|141220406|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
70867048|NCT03855228|141220406|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
71141553|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|1.58||||0.3788|TWO_SIDED|95.0|0.57|4.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.34|0.57|0.3788
71141554|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|2.82||||0.0424|TWO_SIDED|95.0|1.04|7.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.70|1.04|0.0424
71141555|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|3.69||||0.0139|TWO_SIDED|95.0|1.3|10.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||10.43|1.30|0.0139
71141556|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|1.67||||0.3057|TWO_SIDED|95.0|0.63|4.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.42|0.63|0.3057
71141557|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|1.55||||0.3717|TWO_SIDED|95.0|0.59|4.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.02|0.59|0.3717
71141558|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|3.32||||0.0252|TWO_SIDED|95.0|1.16|9.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||9.50|1.16|0.0252
71141559|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|3.56||||0.0235|TWO_SIDED|95.0|1.19|10.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||10.69|1.19|0.0235
71141560|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|1.25||||0.658|TWO_SIDED|95.0|0.46|3.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.39|0.46|0.6580
70949943|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.46|STANDARD_ERROR_OF_MEAN|0.345|||TWO_SIDED|90.0|-1.03|0.11||||||Week 2-HSS0103-Swelling At It's Worst||0.11|-1.03|
70949944|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|0.357|||TWO_SIDED|90.0|-0.99|0.19||||||Week 2-HSS0103-Swelling At It's Worst||0.19|-0.99|
70949945|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.446|||TWO_SIDED|90.0|-0.58|0.9||||||Week 4-HSS0103-Swelling At It's Worst||0.90|-0.58|
71141561|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|4.58||||0.0061|TWO_SIDED|95.0|1.54|13.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||13.62|1.54|0.0061
71141562|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|3.7||||0.0149|TWO_SIDED|95.0|1.29|10.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||10.61|1.29|0.0149
71141563|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|0.95||||0.9282|TWO_SIDED|95.0|0.35|2.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||2.62|0.35|0.9282
71141564|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|0.87||||0.7902|TWO_SIDED|95.0|0.33|2.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||2.35|0.33|0.7902
71141565|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|2.22||||0.1603|TWO_SIDED|95.0|0.73|6.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.74|0.73|0.1603
71141566|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|2.55||||0.1144|TWO_SIDED|95.0|0.8|8.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.14|0.80|0.1144
70949946|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.17|STANDARD_ERROR_OF_MEAN|0.424|||TWO_SIDED|90.0|-0.87|0.53||||||Week 4-HSS0103-Swelling At It's Worst||0.53|-0.87|
70949947|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.443|||TWO_SIDED|90.0|-0.65|0.82||||||Week 4-HSS0103-Swelling At It's Worst||0.82|-0.65|
70867049|NCT03855228|141220406|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
70867050|NCT03855228|141220406|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
70867051|NCT03855228|141220406|SUPERIORITY|||||||0.17|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.17
70867052|NCT03855228|141220407|SUPERIORITY|||||||0.88|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.88
70949948|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.7|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|90.0|-0.15|1.54||||||Week 6-HSS0103-Swelling At It's Worst||1.54|-0.15|
70949949|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.02|STANDARD_ERROR_OF_MEAN|0.493|||TWO_SIDED|90.0|-0.83|0.8||||||Week 6-HSS0103-Swelling At It's Worst||0.80|-0.83|
70949950|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.23|STANDARD_ERROR_OF_MEAN|0.513|||TWO_SIDED|90.0|-0.62|1.08||||||Week 6-HSS0103-Swelling At It's Worst||1.08|-0.62|
70949951|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.29|STANDARD_ERROR_OF_MEAN|0.507|||TWO_SIDED|90.0|-0.55|1.13||||||Week 8-HSS0103-Swelling At It's Worst||1.13|-0.55|
70949952|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|0.489|||TWO_SIDED|90.0|-0.81|0.81||||||Week 8-HSS0103-Swelling At It's Worst||0.81|-0.81|
70949953|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.5|STANDARD_ERROR_OF_MEAN|0.514|||TWO_SIDED|90.0|-0.35|1.35||||||Week 8-HSS0103-Swelling At It's Worst||1.35|-0.35|
70867053|NCT03855228|141220407|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
70867054|NCT03855228|141220407|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
70867055|NCT03855228|141220407|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
70949954|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.07|STANDARD_ERROR_OF_MEAN|0.532|||TWO_SIDED|90.0|-0.81|0.95||||||Week 12-HSS0103-Swelling At It's Worst||0.95|-0.81|
70949955|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.47|STANDARD_ERROR_OF_MEAN|0.505|||TWO_SIDED|90.0|-1.3|0.37||||||Week 12-HSS0103-Swelling At It's Worst||0.37|-1.30|
70949956|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.04|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-0.92|0.84||||||Week 12-HSS0103-Swelling At It's Worst||0.84|-0.92|
70949957|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.23|STANDARD_ERROR_OF_MEAN|0.589|||TWO_SIDED|90.0|-0.75|1.2||||||Week 16-HSS0103-Swelling At It's Worst||1.20|-0.75|
70949958|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-1.06|STANDARD_ERROR_OF_MEAN|0.561|||TWO_SIDED|90.0|-1.99|-0.13||||||Week 16-HSS0103-Swelling At It's Worst||-0.13|-1.99|
70949959|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-1.02|STANDARD_ERROR_OF_MEAN|0.586|||TWO_SIDED|90.0|-1.99|-0.05||||||Week 16-HSS0103-Swelling At It's Worst||-0.05|-1.99|
70949960|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.262|||TWO_SIDED|90.0|-0.27|0.59||||||Week 1-HSS0104-Tiredness At It's Worst||0.59|-0.27|
70949961|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.57|STANDARD_ERROR_OF_MEAN|0.255|||TWO_SIDED|90.0|-0.99|-0.15||||||Week 1-HSS0104-Tiredness At It's Worst||-0.15|-0.99|
70949962|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.262|||TWO_SIDED|90.0|-0.35|0.52||||||Week 1-HSS0104-Tiredness At It's Worst||0.52|-0.35|
70949963|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.06|STANDARD_ERROR_OF_MEAN|0.357|||TWO_SIDED|90.0|-0.54|0.65||||||Week 2-HSS0104-Tiredness At It's Worst||0.65|-0.54|
70949964|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.44|STANDARD_ERROR_OF_MEAN|0.344|||TWO_SIDED|90.0|-1.01|0.13||||||Week 2-HSS0104-Tiredness At It's Worst||0.13|-1.01|
70949965|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.26|STANDARD_ERROR_OF_MEAN|0.356|||TWO_SIDED|90.0|-0.33|0.85||||||Week 2-HSS0104-Tiredness At It's Worst||0.85|-0.33|
70949966|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.12|STANDARD_ERROR_OF_MEAN|0.434|||TWO_SIDED|90.0|-0.83|0.6||||||Week 4-HSS0104-Tiredness At It's Worst||0.60|-0.83|
71141567|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|0.75||||0.5903|TWO_SIDED|95.0|0.26|2.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||2.13|0.26|0.5903
70867056|NCT03855228|141220407|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
70867057|NCT03855228|141220407|SUPERIORITY|||||||0.22|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.22
70867058|NCT03855228|141220408|SUPERIORITY|||||||0.65|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.65
70867059|NCT03855228|141220408|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
71141568|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|3.89||||0.029|TWO_SIDED|95.0|1.15|13.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.16|1.15|0.0290
71141569|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|2.12||||0.1721|TWO_SIDED|95.0|0.72|6.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.26|0.72|0.1721
71141570|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|1.83||||0.2439|TWO_SIDED|95.0|0.66|5.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.09|0.66|0.2439
71141571|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|1.18||||0.7402|TWO_SIDED|95.0|0.44|3.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.19|0.44|0.7402
71141572|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|3.17||||0.0422|TWO_SIDED|95.0|1.04|9.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||9.63|1.04|0.0422
71141573|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|5.44||||0.0061|TWO_SIDED|95.0|1.62|18.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||18.27|1.62|0.0061
70867060|NCT03855228|141220408|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
70867061|NCT03855228|141220408|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
70867062|NCT03855228|141220408|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
71141574|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|1.71||||0.3191|TWO_SIDED|95.0|0.59|4.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.92|0.59|0.3191
71141575|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|5.91||||0.0037|TWO_SIDED|95.0|1.78|19.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||19.66|1.78|0.0037
71141576|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|4.02||||0.0139|TWO_SIDED|95.0|1.33|12.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||12.20|1.33|0.0139
71141577|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|1.59||||0.3757|TWO_SIDED|95.0|0.57|4.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.42|0.57|0.3757
71141578|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|1.21||||0.7087|TWO_SIDED|95.0|0.45|3.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.28|0.45|0.7087
71141579|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|2.53||||0.1083|TWO_SIDED|95.0|0.81|7.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.88|0.81|0.1083
70867063|NCT03855228|141220408|SUPERIORITY|||||||0.92|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.92
70867064|NCT03855228|141220409|SUPERIORITY|||||||0.95|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.95
70867065|NCT03855228|141220409|SUPERIORITY|||||||0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.01
70867066|NCT03855228|141220409|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
70867067|NCT03855228|141220409|SUPERIORITY|||||||0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.01
70867068|NCT03855228|141220409|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
70867069|NCT03855228|141220409|SUPERIORITY|||||||0.58|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.58
70867070|NCT03855228|141220410|SUPERIORITY|||||||0.29|||||||ANOVA|||||||0.29
70867071|NCT03855228|141220410|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
70867072|NCT03855228|141220410|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
70867073|NCT03855228|141220410|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
70867074|NCT03855228|141220410|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
70867075|NCT03855228|141220410|SUPERIORITY|||||||0.8|||||||ANOVA|||||||0.80
70867076|NCT03855228|141220411|SUPERIORITY|||||||0.41|||||||ANOVA|||||||0.41
70867077|NCT03855228|141220411|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
70867078|NCT03855228|141220411|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
70867079|NCT03855228|141220411|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
70867080|NCT03855228|141220411|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
70867081|NCT03855228|141220411|SUPERIORITY|||||||0.08|||||||ANOVA|||||||0.08
70867082|NCT01893203|141220414|SUPERIORITY_OR_OTHER|||||||0.375|||||||McNemar|||||||0.375
70867083|NCT03355365|141220446|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
70867084|NCT03355365|141220447|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||||||0.28
70867085|NCT03355365|141220448|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
70867086|NCT03355365|141220449|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
70867087|NCT03355365|141220450|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||.43
70867088|NCT03355365|141220451|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
70867089|NCT03355365|141220452|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
70867090|NCT03355365|141220453|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||||||.71
70867091|NCT03355365|141220454|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
70867092|NCT01952145|141220455|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of IDegLira versus IGlar was considered as confirmed, if the 95% confidence interval (CI) for the mean treatment difference was entirely below 0.30%.|Treatment contrast|-0.59|||<|0.001|TWO_SIDED|95.0|-0.74|-0.45|||ANCOVA|||This primary endpoint was analysed on the FAS using an ANCOVA model with treatment and region as fixed effects and baseline HbA1c value as covariate.||-0.45|-0.74|< 0.001
70867093|NCT05338216|141220466|SUPERIORITY||Mean Difference (Final Values)|19.63||||0.021||95.0|4.37|36.24||Threshold for significance: p \< 0.05. No correction for multiple comparisons performed due to only two tests conducted and exploratory nature of this pilot study.|Wilcoxon (Mann-Whitney)|||Hypothesis: Compliance would be significantly higher for micro-interaction based versus traditional EMA. Null hypothesis: No difference between conditions.||36.24|4.37|0.021
70867094|NCT05338216|141220467|SUPERIORITY||Mean Difference (Final Values)|17.34||||0.027||95.0|0.78|32.77||Threshold for significance: p \< 0.05. No correction for multiple comparisons performed due to only two tests conducted and exploratory nature of this pilot study.|Wilcoxon (Mann-Whitney)|||Hypothesis: Completion would be significantly higher for micro-interaction based versus traditional EMA. Null hypothesis: No difference between conditions.||32.77|0.78|0.027
70867095|NCT00413244|141220470|SUPERIORITY_OR_OTHER|||||||0.03|||||||log mean|||"Statistician used all the time points post-baseline together (Overall). The result gives the estimates and 95% CI of the treatment effect from longitudinal analyses (generalized estimating equation method) which basically pools data from all visits post-baseline."||||0.03
70867096|NCT00494299|141220515|SUPERIORITY_OR_OTHER||Log Rank|0.2520462|||||||||||||The comparison between the 2 groups is done using the log rank test stratified by the response of TACE (Responder group A versus Responder group B), ECOG performance status (PS) (0 versus 1) and the number of prior TACE (1 versus 2).|||||
70867097|NCT00494299|141220515|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8735||||||95.0|0.6972|1.0942|||||Hazard Ratio: Sorafenib/Placebo.|||1.0942|0.6972|
70867098|NCT01589978|141220567|NON_INFERIORITY_OR_EQUIVALENCE|Given the performance goal of 3.2%, with expected rate for PROMUS Element Plus of 2.2% and a one-sided 5% significance level, approximately 1,706 PLATINUM-like patients will provide at least 80% power to reject the null hypothesis if it is false.|||||<|0.0001|||||||Chi-squared|||One-sided, single binomial test will be performed to compare observed rate against performance goal, the normal approximation of the test statistic will be used. The performance goal is met if the one-sided upper 95% confidence bound for the observed binary rate is less than performance goal.||||<.0001
70867099|NCT01589978|141220587|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is calculated for one-sample chi-square test for a single proportion using nQuery AdvisorVersion 5.0. The expected annual increase in ST rate is estimated to be 0.4% based on the current data available from the pooled TAXUS Express and pooled TAXUS Liberté data and the PG is 1.0% using a delta of 0.6%. Given a one-sided 5% significance level, a minimum of 1,660 PLATINUM-like patients at 5-yrs will be required to provide 90% power to reject the null hypothesis if it is false.|||||<|0.0001|||||||Chi-squared|||The expected annual increase of stent thrombosis rate is assumed to be 0.4%, based on the observed increase in incidence rate of stent thrombosis of approximately 0.4% annually for PLATINUM-like patients in the pooled TAXUS SR Express and pooled TAXUS Liberté data. Using a delta of 0.6%, the performance goal is set to 1.0% (expected rate + delta = 0.4% + 0.6% = 1.0%).||||<.0001
70867100|NCT02925117|141220640|SUPERIORITY||Least Squares (LS) Mean Difference|-51.4|STANDARD_ERROR_OF_MEAN|7.65|<|0.001|TWO_SIDED|95.0|-66.5|-36.3|||ANCOVA|Analysis of covariance (ANCOVA) with stratum (geographic region), baseline value, and treatment in the model.||||-36.3|-66.5|< 0.001
70867101|NCT02925117|141220640|SUPERIORITY||LS Mean Difference|-38.7|STANDARD_ERROR_OF_MEAN|7.61|<|0.001|TWO_SIDED|95.0|-53.7|-23.6|||ANCOVA|Analysis of covariance (ANCOVA) with stratum (geographic region), baseline value, and treatment in the model.||||-23.6|-53.7|<0.001
70867102|NCT02925117|141220640|SUPERIORITY||LS Mean Difference|-16.4|STANDARD_ERROR_OF_MEAN|7.61||0.032|TWO_SIDED|95.0|-31.4|-1.4|||ANCOVA|Analysis of covariance (ANCOVA) with stratum (geographic region), baseline value, and treatment in the model.||||-1.4|-31.4|0.032
70867103|NCT02925117|141220641|SUPERIORITY||Adjusted Difference|58.7|||<|0.001|TWO_SIDED|95.0|42.5|74.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).||||74.8|42.5|< 0.001
70867104|NCT02925117|141220641|SUPERIORITY||Adjusted Difference|42.5|||<|0.001|TWO_SIDED|95.0|25.5|59.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).||||59.6|25.5|<0.001
70867105|NCT02925117|141220641|SUPERIORITY||Adjusted Difference|18.7||||0.022|TWO_SIDED|95.0|2.7|34.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).||||34.7|2.7|0.022
70867106|NCT02925117|141220642|SUPERIORITY||Adjusted Difference|46.9|||<|0.001|TWO_SIDED|95.0|31.1|62.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).||||62.7|31.1|<0.001
70867107|NCT02925117|141220642|SUPERIORITY||Adjusted Difference|28.6|||<|0.001|TWO_SIDED|95.0|13.8|43.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).||||43.4|13.8|<0.001
70867108|NCT02925117|141220642|SUPERIORITY||Adjusted Difference|11.9||||0.044|TWO_SIDED|95.0|0.3|23.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).||||23.5|0.3|0.044
70867109|NCT02925117|141220643|SUPERIORITY||LS Mean Difference|-59.3|STANDARD_ERROR_OF_MEAN|6.58|<|0.001|TWO_SIDED|95.0|-72.3|-46.3|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 2||-46.3|-72.3|<0.001
70867110|NCT02925117|141220643|SUPERIORITY||LS Mean Difference|-47.7|STANDARD_ERROR_OF_MEAN|6.78|<|0.001|TWO_SIDED|95.0|-61.1|-34.3|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 2||-34.3|-61.1|<0.001
70867111|NCT02925117|141220643|SUPERIORITY||LS Mean Difference|-31.1|STANDARD_ERROR_OF_MEAN|6.7|<|0.001|TWO_SIDED|95.0|-44.3|-17.8|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 2||-17.8|-44.3|<0.001
70867112|NCT02925117|141220643|SUPERIORITY||LS Mean Difference|-66.4|STANDARD_ERROR_OF_MEAN|8.85|<|0.001|TWO_SIDED|95.0|-83.9|-48.9|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 8||-48.9|-83.9|<0.001
70867113|NCT02925117|141220643|SUPERIORITY||LS Mean Difference|-38.4|STANDARD_ERROR_OF_MEAN|9.13|<|0.001|TWO_SIDED|95.0|-56.4|-20.4|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 8||-20.4|-56.4|<0.001
70867114|NCT02925117|141220643|SUPERIORITY||LS Mean Difference|-28.9|STANDARD_ERROR_OF_MEAN|8.96||0.002|TWO_SIDED|95.0|-46.6|-11.2|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 8||-11.2|-46.6|0.002
70867115|NCT02925117|141220643|SUPERIORITY||LS Mean Difference|-59.2|STANDARD_ERROR_OF_MEAN|9.78|<|0.001|TWO_SIDED|95.0|-78.6|-39.9|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 16||-39.9|-78.6|<0.001
70867116|NCT02925117|141220643|SUPERIORITY||LS Mean Difference|-38.3|STANDARD_ERROR_OF_MEAN|10.08|<|0.001|TWO_SIDED|95.0|-58.3|-18.4|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 16||-18.4|-58.3|<0.001
70867117|NCT02925117|141220643|SUPERIORITY||LS Mean Difference|-29.9|STANDARD_ERROR_OF_MEAN|9.9||0.003|TWO_SIDED|95.0|-49.4|-10.3|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 16||-10.3|-49.4|0.003
70867118|NCT02925117|141220644|SUPERIORITY||LS Mean Difference|-65.3|STANDARD_ERROR_OF_MEAN|7.46|<|0.001|TWO_SIDED|95.0|-80.0|-50.5|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||||-50.5|-80.0|<0.001
70867119|NCT02925117|141220644|SUPERIORITY||LS Mean Difference|-47.9|STANDARD_ERROR_OF_MEAN|7.42|<|0.001|TWO_SIDED|95.0|-62.6|-33.3|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||||-33.3|-62.6|<0.001
70867120|NCT02925117|141220644|SUPERIORITY||LS Mean Difference|-26.2|STANDARD_ERROR_OF_MEAN|7.42|<|0.001|TWO_SIDED|95.0|-40.8|-11.5|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||||-11.5|-40.8|<0.001
70867121|NCT02925117|141220645|SUPERIORITY||LS Mean Difference|-58.3|STANDARD_ERROR_OF_MEAN|6.78|<|0.001|TWO_SIDED|95.0|-71.7|-44.9|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in SCORAD at Week 8||-44.9|-71.7|<0.001
71141580|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|3.21||||0.0473|TWO_SIDED|95.0|1.01|10.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||10.14|1.01|0.0473
71141581|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|1.89||||0.2481|TWO_SIDED|95.0|0.64|5.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.60|0.64|0.2481
70867122|NCT02925117|141220645|SUPERIORITY||LS Mean Difference|-37.1|STANDARD_ERROR_OF_MEAN|6.94|<|0.001|TWO_SIDED|95.0|-50.8|-23.4|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in SCORAD at Week 8||-23.4|-50.8|<0.001
70867123|NCT02925117|141220645|SUPERIORITY||LS Mean Difference|-28.4|STANDARD_ERROR_OF_MEAN|6.81|<|0.001|TWO_SIDED|95.0|-41.9|-15.0|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in SCORAD at Week 8||-15.0|-41.9|<0.001
70867124|NCT02925117|141220645|SUPERIORITY||LS Mean Difference|-48.0|STANDARD_ERROR_OF_MEAN|6.93|<|0.001|TWO_SIDED|95.0|-61.7|-34.3|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in SCORAD at Week 16||-34.3|-61.7|<0.001
70867125|NCT02925117|141220645|SUPERIORITY||LS Mean Difference|-34.5|STANDARD_ERROR_OF_MEAN|7.1|<|0.001|TWO_SIDED|95.0|-48.5|-20.5|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in SCORAD at Week 16||-20.5|-48.5|<0.001
70867126|NCT02925117|141220645|SUPERIORITY||LS Mean Difference|-20.2|STANDARD_ERROR_OF_MEAN|6.96||0.004|TWO_SIDED|95.0|-33.9|-6.4|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in SCORAD at Week 16||-6.4|-33.9|0.004
70867127|NCT02925117|141220646|SUPERIORITY||Adjusted Difference|72.7|||<|0.001|TWO_SIDED|95.0|58.3|87.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||||87.1|58.3|<0.001
70867128|NCT02925117|141220646|SUPERIORITY||Adjusted Difference|44.9|||<|0.001|TWO_SIDED|95.0|27.9|61.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||||61.9|27.9|<0.001
70867129|NCT02925117|141220646|SUPERIORITY||Adjusted Difference|23.4||||0.004|TWO_SIDED|95.0|7.5|39.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||||39.4|7.5|0.004
70867130|NCT02925117|141220647|SUPERIORITY||Adjusted Difference|70.7|||<|0.001|TWO_SIDED|95.0|56.2|85.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 50 Response at Week 8||85.2|56.2|<0.001
71141582|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|5.84||||0.0066|TWO_SIDED|95.0|1.64|20.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||20.89|1.64|0.0066
71141583|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|3.06||||0.0466|TWO_SIDED|95.0|1.02|9.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.18|1.02|0.0466
70867131|NCT02925117|141220647|SUPERIORITY||Adjusted Difference|49.0|||<|0.001|TWO_SIDED|95.0|30.8|67.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 50 Response at Week 8||67.3|30.8|<0.001
70867132|NCT02925117|141220647|SUPERIORITY||Adjusted Difference|32.8|||<|0.001|TWO_SIDED|95.0|13.4|52.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 50 Response at Week 8||52.2|13.4|<0.001
70867133|NCT02925117|141220647|SUPERIORITY||Adjusted Difference|60.6|||<|0.001|TWO_SIDED|95.0|45.3|75.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 50 Response at Week 16||75.9|45.3|<0.001
70867134|NCT02925117|141220647|SUPERIORITY||Adjusted Difference|48.6|||<|0.001|TWO_SIDED|95.0|31.3|65.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 50 Response at Week 16||65.9|31.3|<0.001
70867135|NCT02925117|141220647|SUPERIORITY||Adjusted Difference|28.2||||0.003|TWO_SIDED|95.0|9.8|46.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 50 Response at Week 16||46.6|9.8|0.003
70867136|NCT02925117|141220648|SUPERIORITY||Adjusted Difference|43.8|||<|0.001|TWO_SIDED|95.0|29.1|58.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 90 Response at Week 8||58.5|29.1|<0.001
70949967|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.81|STANDARD_ERROR_OF_MEAN|0.414|||TWO_SIDED|90.0|-1.49|-0.12||||||Week 4-HSS0104-Tiredness At It's Worst||-0.12|-1.49|
70949968|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.14|STANDARD_ERROR_OF_MEAN|0.431|||TWO_SIDED|90.0|-0.86|0.57||||||Week 4-HSS0104-Tiredness At It's Worst||0.57|-0.86|
71141584|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|0.92||||0.8769|TWO_SIDED|95.0|0.34|2.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||2.53|0.34|0.8769
71141585|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|1.37||||0.5448|TWO_SIDED|95.0|0.49|3.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.82|0.49|0.5448
71141586|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|1.57||||0.4125|TWO_SIDED|95.0|0.53|4.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.64|0.53|0.4125
71141587|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|3.36||||0.05|TWO_SIDED|95.0|1.0|11.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||11.30|1.00|0.0500
70867137|NCT02925117|141220648|SUPERIORITY||Adjusted Difference|26.1|||<|0.001|TWO_SIDED|95.0|12.6|39.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 90 Response at Week 8||39.6|12.6|<0.001
70867138|NCT02925117|141220648|SUPERIORITY||Adjusted Difference|9.4||||0.051|TWO_SIDED|95.0|0.0|18.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 90 Response at Week 8||18.8|-0.0|0.051
70867139|NCT02925117|141220648|SUPERIORITY||Adjusted Difference|46.9|||<|0.001|TWO_SIDED|95.0|31.3|62.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 90 Response at Week 16||62.4|31.3|<0.001
70867140|NCT02925117|141220648|SUPERIORITY||Adjusted Difference|23.8||||0.001|TWO_SIDED|95.0|9.6|38.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 90 Response at Week 16||38.1|9.6|0.001
70867141|NCT02925117|141220648|SUPERIORITY||Adjusted Difference|11.8||||0.049|TWO_SIDED|95.0|0.1|23.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 90 Response at Week 16||23.6|0.1|0.049
70867142|NCT02925117|141220649|SUPERIORITY||Adjusted Difference|68.4|||<|0.001|TWO_SIDED|95.0|54.0|82.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 50 Response at Week 8||82.8|54.0|<0.001
70867143|NCT02925117|141220649|SUPERIORITY||Adjusted Difference|35.3|||<|0.001|TWO_SIDED|95.0|18.5|52.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 50 Response at Week 8||52.2|18.5|<0.001
70867144|NCT02925117|141220649|SUPERIORITY||Adjusted Difference|25.7||||0.002|TWO_SIDED|95.0|9.6|41.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 50 Response at Week 8||41.7|9.6|0.002
70949969|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.04|STANDARD_ERROR_OF_MEAN|0.483|||TWO_SIDED|90.0|-0.76|0.84||||||Week 6-HSS0104-Tiredness At It's Worst||0.84|-0.76|
70949970|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.52|STANDARD_ERROR_OF_MEAN|0.466|||TWO_SIDED|90.0|-1.29|0.26||||||Week 6-HSS0104-Tiredness At It's Worst||0.26|-1.29|
70949971|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.485|||TWO_SIDED|90.0|-0.68|0.92||||||Week 6-HSS0104-Tiredness At It's Worst||0.92|-0.68|
70949972|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.17|STANDARD_ERROR_OF_MEAN|0.483|||TWO_SIDED|90.0|-0.96|0.63||||||Week 8-HSS0104-Tiredness At It's Worst||0.63|-0.96|
71141588|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|1.32||||0.6167|TWO_SIDED|95.0|0.45|3.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.87|0.45|0.6167
71141589|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0233|TWO_SIDED|95.0|1.21|13.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||13.26|1.21|0.0233
70867145|NCT02925117|141220649|SUPERIORITY||Adjusted Difference|54.5|||<|0.001|TWO_SIDED|95.0|39.0|69.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 50 Response at Week 16||69.9|39.0|<0.001
70867146|NCT02925117|141220649|SUPERIORITY||Adjusted Difference|35.8|||<|0.001|TWO_SIDED|95.0|19.1|52.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 50 Response at Week 16||52.5|19.1|<0.001
70867147|NCT02925117|141220649|SUPERIORITY||Adjusted Difference|21.2||||0.008|TWO_SIDED|95.0|5.7|36.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 50 Response at Week 16||36.8|5.7|0.008
70867148|NCT02925117|141220650|SUPERIORITY||Adjusted Difference|30.4|||<|0.001|TWO_SIDED|95.0|16.2|44.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 75 Response at Week 8||44.6|16.2|<0.001
70867149|NCT02925117|141220650|SUPERIORITY||Adjusted Difference|9.4||||0.052|TWO_SIDED|95.0|-0.1|18.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 75 Response at Week 8||18.9|-0.1|0.052
70867150|NCT02925117|141220650|SUPERIORITY||Adjusted Difference|9.3||||0.048|TWO_SIDED|95.0|0.1|18.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 75 Response at Week 8||18.5|0.1|0.048
70867151|NCT02925117|141220650|SUPERIORITY||Adjusted Difference|37.7|||<|0.001|TWO_SIDED|95.0|22.2|53.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 75 Response at Week 16||53.3|22.2|<0.001
70867152|NCT02925117|141220650|SUPERIORITY||Adjusted Difference|19.0||||0.006|TWO_SIDED|95.0|5.6|32.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 75 Response at Week 16||32.5|5.6|0.006
70867153|NCT02925117|141220650|SUPERIORITY||Adjusted Difference|2.4||||0.581|TWO_SIDED|95.0|-6.0|10.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 75 Response at Week 16||10.8|-6.0|0.581
70949973|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.53|STANDARD_ERROR_OF_MEAN|0.466|||TWO_SIDED|90.0|-1.31|0.24||||||Week 8-HSS0104-Tiredness At It's Worst||0.24|-1.31|
70867154|NCT02925117|141220651|SUPERIORITY||Adjusted Difference|14.2||||0.012|TWO_SIDED|95.0|3.2|25.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 90 Response at Week 8||25.2|3.2|0.012
71141590|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|2.68||||0.0803|TWO_SIDED|95.0|0.89|8.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.09|0.89|0.0803
70867155|NCT02925117|141220651|SUPERIORITY||Adjusted Difference|2.3||||0.428|TWO_SIDED|95.0|-3.4|8.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 90 Response at Week 8||8.0|-3.4|0.428
70867156|NCT02925117|141220651|SUPERIORITY||Adjusted Difference|4.6||||0.206|TWO_SIDED|95.0|-2.5|11.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 90 Response at Week 8||11.8|-2.5|0.206
70867157|NCT02925117|141220651|SUPERIORITY||Adjusted Difference|23.3|||<|0.001|TWO_SIDED|95.0|10.4|36.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 90 Response at Week 16||36.2|10.4|<0.001
70867158|NCT02925117|141220651|SUPERIORITY||Adjusted Difference|9.4||||0.048|TWO_SIDED|95.0|0.1|18.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 90 Response at Week 16||18.8|0.1|0.048
70867159|NCT02925117|141220651|SUPERIORITY||Adjusted Difference|2.4||||0.426|TWO_SIDED|95.0|-3.4|8.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 90 Response at Week 16||8.1|-3.4|0.426
70867160|NCT02925117|141220657|SUPERIORITY||LS Mean Difference|-26.5|STANDARD_ERROR_OF_MEAN|4.25|<|0.001|TWO_SIDED|95.0|-34.9|-18.1|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||||-18.1|-34.9|<0.001
70867161|NCT02925117|141220657|SUPERIORITY||LS Mean Difference|-23.0|STANDARD_ERROR_OF_MEAN|4.27|<|0.001|TWO_SIDED|95.0|-31.4|-14.6|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||||-14.6|-31.4|<0.001
70867162|NCT02925117|141220657|SUPERIORITY||LS Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|4.25||0.075|TWO_SIDED|95.0|-16.0|0.8|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||||0.8|-16.0|0.075
70867163|NCT02925117|141220658|SUPERIORITY||Adjusted Difference|47.4|||<|0.001|TWO_SIDED|95.0|29.6|65.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||||65.2|29.6|<0.001
70867164|NCT02925117|141220658|SUPERIORITY||Adjusted Difference|53.4|||<|0.001|TWO_SIDED|95.0|35.5|71.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||||71.3|35.5|<0.001
70867165|NCT02925117|141220658|SUPERIORITY||Adjusted Difference|18.6||||0.021|TWO_SIDED|95.0|2.8|34.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||||34.3|2.8|0.021
70867166|NCT01972568|141220676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.1208|TWO_SIDED|95.0|0.89|2.72|||Logistic regression model|||||2.72|0.89|0.1208
70867167|NCT01972568|141220684|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.31||||0.0048|TWO_SIDED|95.0|1.44|7.61|||Logistic regression model|||||7.61|1.44|0.0048
70867168|NCT01972568|141220685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96||||0.0202|TWO_SIDED|95.0|1.11|3.46|||Logistic regression model|||||3.46|1.11|0.0202
70949974|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.11|STANDARD_ERROR_OF_MEAN|0.488|||TWO_SIDED|90.0|-0.69|0.92||||||Week 8-HSS0104-Tiredness At It's Worst||0.92|-0.69|
70949975|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.34|STANDARD_ERROR_OF_MEAN|0.527|||TWO_SIDED|90.0|-1.21|0.53||||||Week 12-HSS0104-Tiredness At It's Worst||0.53|-1.21|
71141591|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|2.64||||0.1274|TWO_SIDED|95.0|0.76|9.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.18|0.76|0.1274
70949976|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.81|STANDARD_ERROR_OF_MEAN|0.503|||TWO_SIDED|90.0|-1.64|0.02||||||Week 12-HSS0104-Tiredness At It's Worst||0.02|-1.64|
70949977|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.15|STANDARD_ERROR_OF_MEAN|0.527|||TWO_SIDED|90.0|-0.72|1.02||||||Week 12-HSS0104-Tiredness At It's Worst||1.02|-0.72|
70949978|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.22|STANDARD_ERROR_OF_MEAN|0.559|||TWO_SIDED|90.0|-0.7|1.15||||||Week 16-HSS0104-Tiredness At It's Worst||1.15|-0.70|
70949979|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.56|STANDARD_ERROR_OF_MEAN|0.532|||TWO_SIDED|90.0|-1.44|0.32||||||Week 16-HSS0104-Tiredness At It's Worst||0.32|-1.44|
70949980|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.557|||TWO_SIDED|90.0|-0.83|1.01||||||Week 16-HSS0104-Tiredness At It's Worst||1.01|-0.83|
70949981|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.264|||TWO_SIDED|90.0|-0.39|0.49||||||Week 1-HSS0105-Bothered By Appearance HS Lesion||0.49|-0.39|
70949982|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.32|STANDARD_ERROR_OF_MEAN|0.257|||TWO_SIDED|90.0|-0.75|0.1||||||Week 1-HSS0105-Bothered By Appearance HS Lesion||0.10|-0.75|
70949983|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.02|STANDARD_ERROR_OF_MEAN|0.266|||TWO_SIDED|90.0|-0.46|0.42||||||Week 1-HSS0105-Bothered By Appearance HS Lesion||0.42|-0.46|
70949984|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.333|||TWO_SIDED|90.0|-0.65|0.45||||||Week 2-HSS0105-Bothered By Appearance HS Lesion||0.45|-0.65|
71141592|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|1.05||||0.9445|TWO_SIDED|95.0|0.29|3.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.71|0.29|0.9445
70867169|NCT00306189|141220686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|||<|0.0001||95.0|5.76|8.24|||t-test, 2 sided|||||8.24|5.76|<0.0001
70867170|NCT00306189|141220686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.25|||<|0.0001||95.0|4.1|6.4|||t-test, 2 sided|||||6.4|4.1|<0.0001
70949985|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.8|STANDARD_ERROR_OF_MEAN|0.321|||TWO_SIDED|90.0|-1.33|-0.27||||||Week 2-HSS0105-Bothered By Appearance HS Lesion||-0.27|-1.33|
70949986|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.36|STANDARD_ERROR_OF_MEAN|0.333|||TWO_SIDED|90.0|-0.91|0.19||||||Week 2-HSS0105-Bothered By Appearance HS Lesion||0.19|-0.91|
70949987|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.32|STANDARD_ERROR_OF_MEAN|0.411|||TWO_SIDED|90.0|-0.36|1.0||||||Week 4-HSS0105-Bothered By Appearance HS Lesion||1.00|-0.36|
70949988|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.94|STANDARD_ERROR_OF_MEAN|0.393|||TWO_SIDED|90.0|-1.59|-0.29||||||Week 4-HSS0105-Bothered By Appearance HS Lesion||-0.29|-1.59|
70949989|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.29|STANDARD_ERROR_OF_MEAN|0.411|||TWO_SIDED|90.0|-0.97|0.39||||||Week 4-HSS0105-Bothered By Appearance HS Lesion||0.39|-0.97|
70949990|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.55|STANDARD_ERROR_OF_MEAN|0.454|||TWO_SIDED|90.0|-0.2|1.3||||||Week 6-HSS0105-Bothered By Appearance HS Lesion||1.30|-0.20|
70949991|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.69|STANDARD_ERROR_OF_MEAN|0.439|||TWO_SIDED|90.0|-1.41|0.04||||||Week 6-HSS0105-Bothered By Appearance HS Lesion||0.04|-1.41|
70949992|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.456|||TWO_SIDED|90.0|-0.85|0.66||||||Week 6-HSS0105-Bothered By Appearance HS Lesion||0.66|-0.85|
70949993|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.15|STANDARD_ERROR_OF_MEAN|0.491|||TWO_SIDED|90.0|-0.96|0.66||||||Week 8-HSS0105-Bothered By Appearance HS Lesion||0.66|-0.96|
70949994|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-1.11|STANDARD_ERROR_OF_MEAN|0.473|||TWO_SIDED|90.0|-1.89|-0.33||||||Week 8-HSS0105-Bothered By Appearance HS Lesion||-0.33|-1.89|
70949995|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|0.497|||TWO_SIDED|90.0|-1.13|0.52||||||Week 8-HSS0105-Bothered By Appearance HS Lesion||0.52|-1.13|
70949996|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.547|||TWO_SIDED|90.0|-0.86|0.95||||||Week 12-HSS0105-Bothered By Appearance HS Lesion||0.95|-0.86|
70949997|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.87|STANDARD_ERROR_OF_MEAN|0.523|||TWO_SIDED|90.0|-1.73|-0.01||||||Week 12-HSS0105-Bothered By Appearance HS Lesion||-0.01|-1.73|
70949998|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.547|||TWO_SIDED|90.0|-0.78|1.03||||||Week 12-HSS0105-Bothered By Appearance HS Lesion||1.03|-0.78|
70949999|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|0.39|STANDARD_ERROR_OF_MEAN|0.602|||TWO_SIDED|90.0|-0.6|1.39||||||Week 16-HSS0105-Bothered By Appearance HS Lesion||1.39|-0.60|
70950000|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.95|STANDARD_ERROR_OF_MEAN|0.574|||TWO_SIDED|90.0|-1.9|0.0||||||Week 16-HSS0105-Bothered By Appearance HS Lesion||0.00|-1.90|
71141593|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|1.69||||0.4204|TWO_SIDED|95.0|0.47|6.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.03|0.47|0.4204
70950001|NCT04092452|141401037|SUPERIORITY||Risk Difference (RD)|-0.01|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-1.0|0.99||||||Week 16-HSS0105-Bothered By Appearance HS Lesion||0.99|-1.00|
71141594|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|2.78||||0.1315|TWO_SIDED|95.0|0.74|10.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||10.49|0.74|0.1315
70867171|NCT00306189|141220686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.27|||<|0.0001||95.0|5.06|7.49|||t-test, 2 sided|||||7.49|5.06|<0.0001
71141595|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|3.24||||0.0944|TWO_SIDED|95.0|0.82|12.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||12.87|0.82|0.0944
71141596|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|1.99||||0.2801|TWO_SIDED|95.0|0.57|6.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.89|0.57|0.2801
71141597|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|2.44||||0.1524|TWO_SIDED|95.0|0.72|8.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||8.30|0.72|0.1524
71141598|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|1.38||||0.6129|TWO_SIDED|95.0|0.4|4.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.75|0.40|0.6129
71141599|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|0.63||||0.4617|TWO_SIDED|95.0|0.18|2.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.18|0.18|0.4617
70950002|NCT04092452|141401038|SUPERIORITY||Risk Difference (RD)|0.4|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|-1.7|2.6||||||Week 4||2.6|-1.7|
70950003|NCT04092452|141401038|SUPERIORITY||Risk Difference (RD)|-0.5|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|-2.7|1.7||||||Week 4||1.7|-2.7|
70950004|NCT04092452|141401038|SUPERIORITY||Risk Difference (RD)|0.9|STANDARD_ERROR_OF_MEAN|1.38|||TWO_SIDED|90.0|-1.4|3.2||||||Week 4||3.2|-1.4|
70950005|NCT04092452|141401038|SUPERIORITY||Risk Difference (RD)|-0.5|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|90.0|-2.7|1.6||||||Week 8||1.6|-2.7|
71141600|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|0.74||||0.6519|TWO_SIDED|95.0|0.2|2.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.70|0.20|0.6519
71141601|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|0.84||||0.8011|TWO_SIDED|95.0|0.22|3.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.18|0.22|0.8011
71141602|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|1.95||||0.3254|TWO_SIDED|95.0|0.51|7.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||7.41|0.51|0.3254
71141603|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|2.0||||0.273|TWO_SIDED|95.0|0.58|6.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||6.94|0.58|0.2730
71141604|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|1.31||||0.6601|TWO_SIDED|95.0|0.39|4.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.41|0.39|0.6601
71141605|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|0.74||||0.6588|TWO_SIDED|95.0|0.2|2.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.76|0.20|0.6588
70950006|NCT04092452|141401038|SUPERIORITY||Risk Difference (RD)|-1.1|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|90.0|-3.3|1.0||||||Week 8||1.0|-3.3|
70950007|NCT04092452|141401038|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|1.34|||TWO_SIDED|90.0|-2.2|2.2||||||Week 8||2.2|-2.2|
70950008|NCT04092452|141401038|SUPERIORITY||Risk Difference (RD)|-0.8|STANDARD_ERROR_OF_MEAN|1.44|||TWO_SIDED|90.0|-3.2|1.6||||||Week 12||1.6|-3.2|
70950009|NCT04092452|141401038|SUPERIORITY||Risk Difference (RD)|-2.0|STANDARD_ERROR_OF_MEAN|1.39|||TWO_SIDED|90.0|-4.3|0.3||||||Week 12||0.3|-4.3|
70950010|NCT04092452|141401038|SUPERIORITY||Risk Difference (RD)|-0.2|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|90.0|-2.6|2.2||||||Week 12||2.2|-2.6|
70950011|NCT04092452|141401038|SUPERIORITY||Risk Difference (RD)|1.7|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-0.7|4.2||||||Week 16||4.2|-0.7|
70950012|NCT04092452|141401038|SUPERIORITY||Risk Difference (RD)|-1.2|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|90.0|-3.6|1.2||||||Week 16||1.2|-3.6|
70950013|NCT04092452|141401038|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|1.51|||TWO_SIDED|90.0|-2.4|2.6||||||Week 16||2.6|-2.4|
70950014|NCT04092452|141401039|SUPERIORITY||Risk Difference (RD)|0.4|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|-1.7|2.6||||||Week 4||2.6|-1.7|
70950015|NCT04092452|141401039|SUPERIORITY||Risk Difference (RD)|-0.5|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|-2.7|1.7||||||Week 4||1.7|-2.7|
70950016|NCT04092452|141401039|SUPERIORITY||Risk Difference (RD)|0.9|STANDARD_ERROR_OF_MEAN|1.38|||TWO_SIDED|90.0|-1.4|3.2||||||Week 4||3.2|-1.4|
70950017|NCT04092452|141401039|SUPERIORITY||Risk Difference (RD)|-0.5|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|90.0|-2.7|1.6||||||Week 8||1.6|-2.7|
70950018|NCT04092452|141401039|SUPERIORITY||Risk Difference (RD)|-1.1|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|90.0|-3.3|1.0||||||Week 8||1.0|-3.3|
70950019|NCT04092452|141401039|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|1.34|||TWO_SIDED|90.0|-2.2|2.2||||||Week 8||2.2|-2.2|
70950020|NCT04092452|141401039|SUPERIORITY||Risk Difference (RD)|-0.8|STANDARD_ERROR_OF_MEAN|1.44|||TWO_SIDED|90.0|-3.2|1.6||||||Week 12||1.6|-3.2|
70950021|NCT04092452|141401039|SUPERIORITY||Risk Difference (RD)|-2.0|STANDARD_ERROR_OF_MEAN|1.39|||TWO_SIDED|90.0|-4.3|0.3||||||Week 12||0.3|-4.3|
70950022|NCT04092452|141401039|SUPERIORITY||Risk Difference (RD)|-0.2|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|90.0|-2.6|2.2||||||Week 12||2.2|-2.6|
70950023|NCT04092452|141401039|SUPERIORITY||Risk Difference (RD)|1.7|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-0.7|4.2||||||Week 16||4.2|-0.7|
70950024|NCT04092452|141401039|SUPERIORITY||Risk Difference (RD)|-1.2|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|90.0|-3.6|1.2||||||Week 16||1.2|-3.6|
70950025|NCT04092452|141401039|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|1.51|||TWO_SIDED|90.0|-2.4|2.6||||||Week 16||2.6|-2.4|
70950026|NCT04092452|141401040|SUPERIORITY||Risk Difference (RD)|0.2|STANDARD_ERROR_OF_MEAN|5.64|||TWO_SIDED|90.0|-9.1|9.5||||||Week 4||9.5|-9.1|
70950027|NCT04092452|141401040|SUPERIORITY||Risk Difference (RD)|1.2|STANDARD_ERROR_OF_MEAN|5.25|||TWO_SIDED|90.0|-7.4|9.8||||||Week 4||9.8|-7.4|
70950028|NCT04092452|141401040|SUPERIORITY||Risk Difference (RD)|-4.0|STANDARD_ERROR_OF_MEAN|4.52|||TWO_SIDED|90.0|-11.4|3.4||||||Week 4||3.4|-11.4|
70950029|NCT04092452|141401040|SUPERIORITY||Risk Difference (RD)|4.3|STANDARD_ERROR_OF_MEAN|4.57|||TWO_SIDED|90.0|-3.3|11.8||||||Week 8||11.8|-3.3|
70950030|NCT04092452|141401040|SUPERIORITY||Risk Difference (RD)|6.2|STANDARD_ERROR_OF_MEAN|4.87|||TWO_SIDED|90.0|-1.8|14.2||||||Week 8||14.2|-1.8|
70950031|NCT04092452|141401040|SUPERIORITY||Risk Difference (RD)|2.5|STANDARD_DEVIATION|4.42|||TWO_SIDED|90.0|-4.8|9.8||||||Week 8||9.8|-4.8|
70950032|NCT04092452|141401040|SUPERIORITY||Risk Difference (RD)|7.6|STANDARD_ERROR_OF_MEAN|5.43|||TWO_SIDED|90.0|-1.3|16.5||||||Week 12||16.5|-1.3|
70950033|NCT04092452|141401040|SUPERIORITY||Risk Difference (RD)|6.9|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|90.0|-2.0|15.7||||||Week 12||15.7|-2.0|
70950034|NCT04092452|141401040|SUPERIORITY||Risk Difference (RD)|2.9|STANDARD_ERROR_OF_MEAN|5.09|||TWO_SIDED|90.0|-5.5|11.3||||||Week 12||11.3|-5.5|
70950035|NCT04092452|141401040|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|3.88|||TWO_SIDED|90.0|-6.3|6.4||||||Week 16||6.4|-6.3|
70950036|NCT04092452|141401040|SUPERIORITY||Risk Difference (RD)|6.5|STANDARD_ERROR_OF_MEAN|5.63|||TWO_SIDED|90.0|-2.8|15.7||||||Week 16||15.7|-2.8|
70950037|NCT04092452|141401040|SUPERIORITY||Risk Difference (RD)|7.6|STANDARD_ERROR_OF_MEAN|5.64|||TWO_SIDED|90.0|-1.6|16.9||||||Week 16||16.9|-1.6|
70950038|NCT02127125|141401042|SUPERIORITY||||||<|0.025||||||p-value not adjusted for multiple comparison, a priori threshold for significance set at p\<0.025 for multiple comparisons.|Generalized Estimating Equation|||Null hypothesis is that Sevelamer treated Obese subjects with normal glucose tolerance will show no post-treatment change in insulin sensitivity compared to placebo treated subjects.||||<0.025
70950039|NCT02127125|141401042|SUPERIORITY||||||>|0.05||||||p-value not adjusted for multiple comparison, a priori threshold for significance set at p\<0.025 for multiple comparisons.|Generalized Estimating Equation|||Null hypothesis is that Synbiotic treated Obese subjects with normal glucose tolerance will show no post-treatment change in insulin sensitivity compared to placebo treated subjects.||||>0.05
70950040|NCT02127125|141401043|SUPERIORITY||||||>|0.05||||||p-value not adjusted for multiple comparison, a priori threshold for significance set at p\<0.025 for multiple comparisons.|Generalized Estimating Equation|||Null hypothesis is that Sevelamer treated Obese subjects with normal glucose tolerance will show no post-treatment change in insulin sensitivity compared to placebo treated subjects.||||>0.05
70950041|NCT02127125|141401043|SUPERIORITY||||||>|0.05||||||p-value not adjusted for multiple comparison, a priori threshold for significance set at p\<0.025 for multiple comparisons.|Generalized Estimating Equation|||Null hypothesis is that Synbiotic treated Obese subjects with normal glucose tolerance will show no post-treatment change in insulin sensitivity compared to placebo treated subjects.||||>0.05
70950042|NCT02127125|141401044|SUPERIORITY||||||>|0.05||||||p-value not adjusted for multiple comparison, a priori threshold for significance set at p\<0.025 for multiple comparisons.|Generalized Estimating Equation|||Null hypothesis is that Sevelamer treated Obese subjects with normal glucose tolerance will show no post-treatment change in Lactulose:Mannitol ratio compared to placebo treated subjects.||||>0.05
70950043|NCT02127125|141401044|SUPERIORITY||||||>|0.05||||||p-value not adjusted for multiple comparison, a priori threshold for significance set at p\<0.025 for multiple comparisons.|Generalized Estimating Equation|||Null hypothesis is that Synbiotic treated Obese subjects with normal glucose tolerance will show no post-treatment change in Lactulose:Mannitol ratio compared to placebo treated subjects.||||>0.05
71141606|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|0.52||||0.3257|TWO_SIDED|95.0|0.14|1.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.92|0.14|0.3257
70867172|NCT02572401|141220687|SUPERIORITY||Risk Ratio (RR)|0.84|||<|0.05|TWO_SIDED|95.0|0.59|1.21|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).|The numerator is the treatment.|The primary analysis tested the efficacy of the HIV risk reduction intervention by comparing the HIV Risk Reduction Only and HIV Risk Reduction and Text Messaging Arms to the Text Messaging Only and No-Intervention No Text Message Control Arms. This is a test of the main effect of the HIV risk reduction intervention.||1.21|.59|<.05
70867173|NCT02572401|141220687|SUPERIORITY||Risk Ratio (RR)|0.99|||<|0.05|TWO_SIDED|95.0|0.69|1.42|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).|The numerator is the treatment.|This analysis tested the efficacy of the text messaging intervention by comparing the HIV Risk Reduction and Text Messaging and Text Messaging Only Arms to the HIV Risk Reduction Only and No-Intervention No Text Message Control Arms. This is a test of the text messaging main effect.||1.42|0.69|<.05
70867174|NCT02572401|141220687|SUPERIORITY||Risk Ratio (RR)|0.72|||<|0.05|TWO_SIDED|95.0|0.35|1.49|||Poisson regression|Adjusted for baseline of the criterion, time of follow-up assessment (6 vs. 12 months), and the HIV x Time and Text Messaging x Time interactions.|The numerator is the treatment.|The analysis tested whether text messaging enhanced the effects of the HIV risk reduction intervention by comparing the HIV Risk Reduction and Text Messaging and No-Intervention No Text Message Arms to the Text Messaging Only and HIV Risk Reduction Only Arms. This is a test of the interaction between the two types of interventions.||1.49|.35|<.05
70867175|NCT02572401|141220688|SUPERIORITY||Risk Ratio (RR)|1.04|||<|0.05|TWO_SIDED|95.0|0.92|1.18|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).|The numerator is the treatment.|The primary analysis tested the efficacy of the HIV risk reduction intervention by comparing the HIV Risk Reduction Only and HIV Risk Reduction and Text Messaging Arms to the Text Messaging Only and No-Intervention No Text Message Control Arms. This is a test of the main effect of the HIV risk reduction intervention.||1.18|0.92|<.05
70867176|NCT02572401|141220688|SUPERIORITY||Risk Ratio (RR)|1.02|||<|0.05|TWO_SIDED|95.0|0.9|1.16|||Poisson regression|Adjusted for baseline of the criterion.|The numerator is the treatment.|This analysis tested the efficacy of the text messaging intervention by comparing the HIV Risk Reduction and Text Messaging and Text Messaging Only Arms to the HIV Risk Reduction Only and No-Intervention No Text Message Control Arms. This is a test of the text messaging main effect.||1.16|0.90|<.05
70867177|NCT02572401|141220688|SUPERIORITY||Risk Ratio (RR)|1.1|||<|0.05|TWO_SIDED|95.0|0.86|1.42|||Poisson regression|Adjusted for baseline of the criterion, time of follow-up assessment (6 vs. 12 months), and the HIV x Time and Text Messaging x Time interactions.|The numerator is the treatment.|The analysis tested whether text messaging enhanced the effects of the HIV risk reduction intervention by comparing the HIV Risk Reduction and Text Messaging and No-Intervention No Text Message Arms to the Text Messaging Only and HIV Risk Reduction Only Arms. This is a test of the interaction between the two types of interventions.||1.42|0.86|<.05
70867178|NCT02572401|141220689|SUPERIORITY||Risk Ratio (RR)|1.05|||<|0.05|TWO_SIDED|95.0|0.89|1.24|||Poisson regression|Adjusted for baseline of the criterion.|The numerator is the treatment.|The primary analysis tested the efficacy of the HIV risk reduction intervention by comparing the HIV Risk Reduction Only and HIV Risk Reduction and Text Messaging Arms to the Text Messaging Only and No-Intervention No Text Message Control Arms. This is a test of the main effect of the HIV risk reduction intervention.||1.24|0.89|<.05
70867179|NCT02572401|141220689|SUPERIORITY||Risk Ratio (RR)|1.1|||<|0.05|TWO_SIDED|95.0|0.94|1.3|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).||This analysis tested the efficacy of the text messaging intervention by comparing the HIV Risk Reduction and Text Messaging and Text Messaging Only Arms to the HIV Risk Reduction Only and No-Intervention No Text Message Control Arms. This is a test of the text messaging main effect.|The numerator is the treatment.|1.30|0.94|<.05
71141607|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|0.42||||0.2229|TWO_SIDED|95.0|0.1|1.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.69|0.10|0.2229
70950044|NCT00848484|141401050|SUPERIORITY_OR_OTHER|||||||0.277||95.0|||||constrained Longitudinal Data Analysis|The repeated measures model included the terms site and sequence \* time with a restriction of the same baseline mean across treatment sequences.||||||0.277
70950045|NCT00848484|141401051|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.1 was used to adjust p-Values among five secondary cognition endpoints.|constrained Longitudinal Data Analysis|The repeated measures model included the terms site and sequence \* time with a restriction of the same baseline mean across treatment sequences.||||||0.686
70950046|NCT00848484|141401052|SUPERIORITY_OR_OTHER|||||||0.933||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.1 was used to adjust p-Values among five secondary cognition endpoints.|constrained Longitudinal Data Analysis|The repeated measures model included the terms site and sequence \* time with a restriction of the same baseline mean across treatment sequences.||||||0.933
70950047|NCT00848484|141401053|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.1 was used to adjust p-Values among 5 secondary cognition endpoints.|constrained Longitudinal Data Analysis|The repeated measures model included the terms site and sequence \* time with a restriction of the same baseline mean across treatment sequences.||||||0.686
70950048|NCT00848484|141401054|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.1 was used to adjust p-Values among five secondary cognition endpoints.|Wilcoxon (Mann-Whitney)|The repeated measures model included the terms site and sequence \* time with a restriction of the same baseline mean across treatment sequences.||||||0.686
70950049|NCT00848484|141401055|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.1 was used to adjust p-Values among 5 secondary cognition endpoints.|constrained Longitudinal Data Analysis|The repeated measures model included the terms site and sequence \* time with a restriction of the same baseline mean across treatment sequences.||||||0.686
70950050|NCT02097303|141401069|OTHER||||||<|1e-05||||||Comparison of ALP levels before and after treatment|t-test, 2 sided|||||||<.00001
70950051|NCT02097303|141401069|OTHER|||||||0.487||||||Comparison of PSA levels before and after treatment|t-test, 2 sided|||||||0.4870
70950052|NCT02975102|141401088|NON_INFERIORITY|A sample size of 33 evaluable patients per treatment group was calculated to provide at least 90% power to demonstrate non-inferiority of CBL-101 to Vismed Multi. Assumptions included a non-inferiority margin of 2 grades and a standard deviation of 2.5|Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-1.2|0.3|||||Treatment difference : CBL-101 - Vismed Multi|||0.3|-1.2|
70950053|NCT02975102|141401089|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
70950054|NCT02975102|141401090|SUPERIORITY|||||||0.0002||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0002
70950055|NCT02975102|141401091|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
70950056|NCT02975102|141401092|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
70950057|NCT02975102|141401093|SUPERIORITY|||||||0.0186||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0186
70950058|NCT02975102|141401094|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
70950059|NCT02975102|141401095|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
70950060|NCT02975102|141401096|SUPERIORITY|||||||0.0011||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0011
70950061|NCT02975102|141401097|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
70950062|NCT02975102|141401098|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
70950063|NCT02975102|141401099|SUPERIORITY|||||||0.005||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.005
70950064|NCT02975102|141401100|SUPERIORITY|||||||0.0008||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0008
70950065|NCT02975102|141401101|SUPERIORITY|||||||0.0026||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0026
70950066|NCT02975102|141401102|SUPERIORITY|||||||0.077||||||Significance level of 0.05 . P-Value result provided only for Global Question|ANCOVA|Adjustment for baseline||||||0.077
70950067|NCT02975102|141401103|SUPERIORITY|||||||0.6097||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.6097
70950068|NCT02975102|141401104|SUPERIORITY|||||||0.231||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.231
70950069|NCT02975102|141401105|SUPERIORITY|||||||0.0135||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0135
70950070|NCT02975102|141401106|SUPERIORITY|||||||0.575||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.575
70950071|NCT04069585|141401107|NON_INFERIORITY|To achieve non-inferiority, the observed p-value must be \<= 0.5 taking into account of the non-inferiority margin (i.e., 10mm difference in Pain VAS between the two treatment groups).|||||<|0.0002||||||One-sided paired t-test|t-test, 1 sided|||||||<0.0002
70950072|NCT01441635|141401123|SUPERIORITY||LS Mean Difference|-205.9|STANDARD_ERROR_OF_MEAN|45.1|<|0.001|TWO_SIDED|95.0|-295.77|-116.01|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-116.01|-295.77|< 0.001
70950073|NCT01441635|141401123|SUPERIORITY||LS Mean Difference|-189.9|STANDARD_ERROR_OF_MEAN|44.36|<|0.001|TWO_SIDED|95.0|-278.33|-101.53|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-101.53|-278.33|< 0.001
70950074|NCT01441635|141401123|SUPERIORITY||LS Mean Difference|-138.0|STANDARD_ERROR_OF_MEAN|40.86||0.001|TWO_SIDED|95.0|-220.18|-55.76|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-55.76|-220.18|0.001
70950075|NCT01441635|141401123|SUPERIORITY||LS Mean Difference|-130.6|STANDARD_ERROR_OF_MEAN|37.68||0.001|TWO_SIDED|95.0|-206.7|-54.6|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-54.60|-206.70|0.001
70950076|NCT01441635|141401124|SUPERIORITY||LS Mean Difference|-75.6|STANDARD_ERROR_OF_MEAN|13.71|<|0.001|TWO_SIDED|95.0|-102.93|-48.28|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-48.28|-102.93|< 0.001
71141608|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|0.43||||0.2425|TWO_SIDED|95.0|0.1|1.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.77|0.10|0.2425
71141609|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9672|TWO_SIDED|95.0|0.23|4.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||4.11|0.23|0.9672
71141610|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|1.43||||0.5838|TWO_SIDED|95.0|0.4|5.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.09|0.40|0.5838
71141611|NCT03192176|141778536|SUPERIORITY||Odds Ratio (OR)|0.95||||0.9361|TWO_SIDED|95.0|0.28|3.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.24|0.28|0.9361
71141612|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0429|TWO_SIDED|95.0|1.03|6.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||6.55|1.03|0.0429
71141613|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|2.81||||0.0296|TWO_SIDED|95.0|1.11|7.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||7.12|1.11|0.0296
71141614|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|4.48||||0.0032|TWO_SIDED|95.0|1.65|12.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||12.13|1.65|0.0032
71141615|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|7.11||||0.0006|TWO_SIDED|95.0|2.31|21.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||21.90|2.31|0.0006
71141616|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|1.8||||0.2073|TWO_SIDED|95.0|0.72|4.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||4.47|0.72|0.2073
71141617|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|3.54||||0.0096|TWO_SIDED|95.0|1.36|9.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||9.20|1.36|0.0096
71141618|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|2.52||||0.0462|TWO_SIDED|95.0|1.02|6.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||6.27|1.02|0.0462
71141619|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|2.26||||0.1387|TWO_SIDED|95.0|0.77|6.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.63|0.77|0.1387
71141620|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|1.71||||0.313|TWO_SIDED|95.0|0.6|4.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||4.84|0.60|0.3130
71141621|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|3.32||||0.0392|TWO_SIDED|95.0|1.06|10.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.40|1.06|0.0392
71141622|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|5.7||||0.0135|TWO_SIDED|95.0|1.43|22.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||22.71|1.43|0.0135
71141623|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|2.85||||0.084|TWO_SIDED|95.0|0.87|9.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||9.36|0.87|0.0840
70867180|NCT02572401|141220689|SUPERIORITY||Risk Ratio (RR)|1.05|||<|0.05|TWO_SIDED|95.0|0.76|1.47|||Poisson regression|Adjusted for baseline of the criterion, time of follow-up assessment (6 vs. 12 months), and the HIV x Time and Text Messaging x Time interactions.|The numerator is the treatment.|The analysis tested whether text messaging enhanced the effects of the HIV risk reduction intervention by comparing the HIV Risk Reduction and Text Messaging and No-Intervention No Text Message Arms to the Text Messaging Only and HIV Risk Reduction Only Arms. This is a test of the interaction between the two types of interventions.||1.47|0.76|<.05
70950077|NCT01441635|141401124|SUPERIORITY||LS Mean Difference|-64.27|STANDARD_ERROR_OF_MEAN|13.48|<|0.001|TWO_SIDED|95.0|-91.14|-37.39|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-37.39|-91.14|< 0.001
70950078|NCT01441635|141401124|SUPERIORITY||LS Mean Difference|-67.67|STANDARD_ERROR_OF_MEAN|22.73||0.005|TWO_SIDED|95.0|-113.39|-21.96|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-21.96|-113.39|0.005
70950079|NCT01441635|141401124|SUPERIORITY||LS mean Difference|-56.84|STANDARD_ERROR_OF_MEAN|8.12|<|0.001|TWO_SIDED|95.0|-73.24|-40.45|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-40.45|-73.24|< 0.001
70950080|NCT01441635|141401125|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
70950081|NCT01441635|141401125|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
70950082|NCT01441635|141401125|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
70950083|NCT01441635|141401125|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71141624|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|4.47||||0.0163|TWO_SIDED|95.0|1.32|15.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||15.17|1.32|0.0163
70950084|NCT01441635|141401126|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
70950085|NCT01441635|141401126|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
70950086|NCT01441635|141401126|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
70950087|NCT01441635|141401126|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
70950088|NCT01441635|141401127|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
70950089|NCT01441635|141401127|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
70950090|NCT01441635|141401127|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
70950091|NCT01441635|141401127|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
70950092|NCT01441635|141401129|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|0.97|2.56|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||2.56|0.97|< 0.001
70950093|NCT01441635|141401129|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|1.0|2.56|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||2.56|1.00|< 0.001
70950094|NCT01441635|141401129|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.4||0.024|TWO_SIDED|95.0|0.13|1.75|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||1.75|0.13|0.024
70950095|NCT01441635|141401129|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.3||0.005|TWO_SIDED|95.0|0.28|1.51|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||1.51|0.28|0.005
70950096|NCT01441635|141401130|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.14||0.011|TWO_SIDED|95.0|-0.63|-0.08|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-0.08|-0.63|0.011
70950097|NCT01441635|141401130|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.14||0.03|TWO_SIDED|95.0|-0.59|-0.03|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-0.03|-0.59|0.030
70950098|NCT01441635|141401130|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.16||0.109|TWO_SIDED|95.0|-0.59|0.06|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||0.06|-0.59|0.109
70950099|NCT01441635|141401130|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.15||0.002|TWO_SIDED|95.0|-0.8|-0.19|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-0.19|-0.80|0.002
70950100|NCT01441635|141401131|SUPERIORITY||LS Mean Difference|-10.29|STANDARD_ERROR_OF_MEAN|4.32||0.02|TWO_SIDED|95.0|-18.9|-1.67|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-1.67|-18.90|0.020
71141625|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|1.41||||0.5056|TWO_SIDED|95.0|0.52|3.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||3.84|0.52|0.5056
70950101|NCT01441635|141401131|SUPERIORITY||LS Mean Difference|-7.62|STANDARD_ERROR_OF_MEAN|4.39||0.087|TWO_SIDED|95.0|-16.36|1.13|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||1.13|-16.36|0.087
70950102|NCT01441635|141401131|SUPERIORITY||LS Mean Difference|-8.81|STANDARD_ERROR_OF_MEAN|4.28||0.045|TWO_SIDED|95.0|-17.43|-0.19|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-0.19|-17.43|0.045
70950103|NCT01441635|141401131|SUPERIORITY||LS Mean Difference|-13.69|STANDARD_ERROR_OF_MEAN|4.14||0.002|TWO_SIDED|95.0|-22.06|-5.32|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-5.32|-22.06|0.002
70950104|NCT01441635|141401132|SUPERIORITY||LS Mean Difference|-5.51|STANDARD_ERROR_OF_MEAN|2.03||0.008|TWO_SIDED|95.0|-9.56|-1.47|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-1.47|-9.56|0.008
70950105|NCT01441635|141401132|SUPERIORITY||LS Mean Difference|-4.95|STANDARD_ERROR_OF_MEAN|2.08||0.02|TWO_SIDED|95.0|-9.11|-0.8|||ANCOVA|||||-0.80|-9.11|0.020
70950106|NCT01441635|141401132|SUPERIORITY||LS Mean Difference|-3.63|STANDARD_ERROR_OF_MEAN|2.75||0.194|TWO_SIDED|95.0|-9.18|1.91|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||1.91|-9.18|0.194
70950107|NCT01441635|141401132|SUPERIORITY||LS Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|2.04||0.001|TWO_SIDED|95.0|-11.33|-3.07|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-3.07|-11.33|0.001
70950108|NCT01441635|141401135|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||< 0.001
70950109|NCT01441635|141401135|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||< 0.001
70950110|NCT01441635|141401135|SUPERIORITY|||||||0.052|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||0.052
70950111|NCT01441635|141401135|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||< 0.001
70950112|NCT01441635|141401136|SUPERIORITY|||||||0.003|||||||Fisher Exact|||||||0.003
70950113|NCT01441635|141401136|SUPERIORITY|||||||0.016|||||||Fisher Exact|||||||0.016
70950114|NCT01441635|141401136|SUPERIORITY|||||||0.012|||||||Fisher Exact|||||||0.012
70950115|NCT01441635|141401136|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
70950116|NCT01441635|141401137|SUPERIORITY|||||||0.161|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor||||||0.161
70950117|NCT01441635|141401137|SUPERIORITY|||||||0.173|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||0.173
70950118|NCT01441635|141401137|SUPERIORITY|||||||0.072|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||0.072
70950119|NCT01441635|141401137|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||0.003
70950120|NCT01441635|141401138|SUPERIORITY|||||||0.203|||||||Fisher Exact|||||||0.203
70950121|NCT01441635|141401138|SUPERIORITY|||||||0.342|||||||Fisher Exact|||||||0.342
70950122|NCT01441635|141401138|SUPERIORITY|||||||0.038|||||||Fisher Exact|||||||0.038
70950123|NCT01441635|141401138|SUPERIORITY|||||||0.111|||||||Fisher Exact|||||||0.111
70950124|NCT01825577|141401143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.9||||0.55|TWO_SIDED||||||t-test, 2 sided|||||||.55
70950125|NCT01825577|141401144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.67|TWO_SIDED||||||t-test, 2 sided|||||||.67
70950126|NCT01055704|141401147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.048|STANDARD_ERROR_OF_MEAN|0.389||0.902|TWO_SIDED|95.0|-0.835|0.739|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.739|-0.835|0.902
70950127|NCT01055704|141401147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.351||0.709|TWO_SIDED|95.0|-0.578|0.841|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.841|-0.578|0.709
70950128|NCT01055704|141401148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.971|STANDARD_ERROR_OF_MEAN|4.669||0.675|TWO_SIDED|95.0|-11.415|7.472|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||7.472|-11.415|0.675
70950129|NCT01055704|141401148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.28|STANDARD_ERROR_OF_MEAN|4.208||0.591|TWO_SIDED|95.0|-10.792|6.233|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||6.233|-10.792|0.591
70950130|NCT01055704|141401149|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-34.425|STANDARD_ERROR_OF_MEAN|14.67||0.024|TWO_SIDED|95.0|-64.097|-4.753|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||-4.753|-64.097|0.024
70950131|NCT01055704|141401149|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.181|STANDARD_ERROR_OF_MEAN|13.24||0.989|TWO_SIDED|95.0|-26.962|26.598|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||26.598|-26.962|0.989
70950132|NCT01055704|141401150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.401|STANDARD_ERROR_OF_MEAN|0.211||0.064|TWO_SIDED|95.0|-0.827|0.025|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.025|-0.827|0.064
70950133|NCT01055704|141401150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.19||0.61|TWO_SIDED|95.0|-0.287|0.482|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.482|-0.287|0.610
70950134|NCT01055704|141401151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.728|STANDARD_ERROR_OF_MEAN|0.497||0.151|TWO_SIDED|95.0|-0.278|1.734|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||1.734|-0.278|0.151
70950135|NCT01055704|141401151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.448||0.806|TWO_SIDED|95.0|-0.795|1.017|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||1.017|-0.795|0.806
70867181|NCT02572401|141220690|SUPERIORITY||Risk Ratio (RR)|1.04|||<|0.05|TWO_SIDED|95.0|0.73|1.48|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).|The numerator is the treatment.|The primary analysis tested the efficacy of the HIV risk reduction intervention by comparing the HIV Risk Reduction Only and HIV Risk Reduction and Text Messaging Arms to the Text Messaging Only and No-Intervention No Text Message Control Arms. This is a test of the main effect of the HIV risk reduction intervention.||1.48|0.73|<.05
70867182|NCT02572401|141220690|SUPERIORITY||Risk Ratio (RR)|1.01|||<|0.05|TWO_SIDED|95.0|0.71|1.45|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).|The numerator is the treatment.|This analysis tested the efficacy of the text messaging intervention by comparing the HIV Risk Reduction and Text Messaging and Text Messaging Only Arms to the HIV Risk Reduction Only and No-Intervention No Text Message Control Arms. This is a test of the text messaging main effect.||1.45|0.71|<.05
70867183|NCT02572401|141220690|SUPERIORITY||Risk Ratio (RR)|1.02|||<|0.05|TWO_SIDED|95.0|0.5|2.08|||Poisson regression|Adjusted for baseline of the criterion, time of follow-up assessment (6 vs. 12 months), and the HIV x Time and Text Messaging x Time interactions.|The numerator is the treatment.|The analysis tested whether text messaging enhanced the effects of the HIV risk reduction intervention by comparing the HIV Risk Reduction and Text Messaging and No-Intervention No Text Message Arms to the Text Messaging Only and HIV Risk Reduction Only Arms. This is a test of the interaction between the two types of interventions.||2.08|.50|<.05
70867184|NCT02572401|141220691|SUPERIORITY||Mean Difference (Final Values)|0.001|||<|0.05|TWO_SIDED|95.0|-0.078|0.08|||Regression, Linear|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).||The primary analysis tested the efficacy of the HIV risk reduction intervention by comparing the HIV Risk Reduction Only and HIV Risk Reduction and Text Messaging Arms to the Text Messaging Only and No-Intervention No Text Message Control Arms. This is a test of the main effect of the HIV risk reduction intervention.||0.080|-0.078|<.05
70867185|NCT02572401|141220691|SUPERIORITY||Mean Difference (Final Values)|-0.003|||<|0.05|TWO_SIDED|95.0|-0.082|0.076|||Regression, Linear|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).||This analysis tested the efficacy of the text messaging intervention by comparing the HIV Risk Reduction and Text Messaging and Text Messaging Only Arms to the HIV Risk Reduction Only and No-Intervention No Text Message Control Arms. This is a test of the text messaging main effect.||0.076|-0.082|<.05
70867186|NCT02572401|141220691|SUPERIORITY||Mean Difference (Final Values)|-0.009|||<|0.05|TWO_SIDED|95.0|-0.167|0.149|||Regression, Linear|Adjusted for baseline of the criterion, time of follow-up assessment (6 vs. 12 months), and the HIV x Time and Text Messaging x Time interactions.||The analysis tested whether text messaging enhanced the effects of the HIV risk reduction intervention by comparing the HIV Risk Reduction and Text Messaging and No-Intervention No Text Message Arms to the Text Messaging Only and HIV Risk Reduction Only Arms. This is a test of the interaction between the two types of interventions.||0.149|-0.167|<.05
70867187|NCT00945893|141220696|NON_INFERIORITY_OR_EQUIVALENCE|The currently proposed study provided at least 99.9% power to rule out a rate increase of 10 percentage points assuming the true difference between the treatment groups is zero and the true fever rate is ≤ 3%. Power is also high if the true difference is slightly greater than zero and the true fever rate is ≤ 3%.|Rate difference|0.0|||||TWO_SIDED|95.0|-6.0|1.9|||Score|||The upper limit of the two-sided 95% CI was evaluated against the prespecified equivalence criterion of 10% which corresponded to the following hypotheses: H0 (null): Rate Difference ≥ 10%, HA (alternative): Rate Difference \< 10%||1.9|-6.0|
70867188|NCT00945893|141220697|SUPERIORITY_OR_OTHER||rate difference|2.5|||||TWO_SIDED|95.0|-8.8|7.7|||score|||The number of participants who experienced a post-dose seroresponse was compared based on the upper limit of the limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).||7.7|-8.8|
70867189|NCT00945893|141220698|SUPERIORITY_OR_OTHER||rate difference|6.1|||||TWO_SIDED|95.0|-5.6|12.6|||score|||The number of participants who experienced a post-dose seroresponse was compared based on the upper limit of the two-sided 95% exact CIs for the rate difference (Vaccine minus Placebo).||12.6|-5.6|
70867190|NCT00945893|141220699|SUPERIORITY_OR_OTHER||rate difference|9.3|||||TWO_SIDED|95.0|-0.8|16.3|||score|||The number of participants who experienced a post-dose seroresponse was compared based on the upper limit of the limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).||16.3|-0.8|
70867191|NCT00945893|141220700|NON_INFERIORITY_OR_EQUIVALENCE|Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% CIs (Chan and Zhang, 1999) on the rate difference (monovalent vaccine minus placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.|Rate difference|10.0|||||TWO_SIDED|95.0|-4.1|22.8|||Score|||||22.8|-4.1|
71141626|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|1.69||||0.3358|TWO_SIDED|95.0|0.58|4.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||4.90|0.58|0.3358
71141627|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|3.05||||0.0696|TWO_SIDED|95.0|0.91|10.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.18|0.91|0.0696
71141628|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|2.8||||0.0794|TWO_SIDED|95.0|0.89|8.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.82|0.89|0.0794
71141629|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|7.32||||0.0149|TWO_SIDED|95.0|1.48|36.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||36.28|1.48|0.0149
71141630|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|4.37||||0.0377|TWO_SIDED|95.0|1.09|17.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||17.59|1.09|0.0377
71141631|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|3.32||||0.0454|TWO_SIDED|95.0|1.03|10.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.77|1.03|0.0454
71141632|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|3.77||||0.039|TWO_SIDED|95.0|1.07|13.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||13.26|1.07|0.0390
71141633|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|2.12||||0.1947|TWO_SIDED|95.0|0.68|6.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.64|0.68|0.1947
70867192|NCT00945893|141220703|NON_INFERIORITY_OR_EQUIVALENCE|Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% CIs (Chan and Zhang, 1999) on the rate difference (monovalent vaccine minus placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.|Rate difference|0.4|||||TWO_SIDED|95.0|-13.9|14.5|||Score|||||14.5|-13.9|
71141634|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|1.79||||0.2913|TWO_SIDED|95.0|0.61|5.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.25|0.61|0.2913
71141635|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|2.21||||0.1665|TWO_SIDED|95.0|0.72|6.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.82|0.72|0.1665
71141636|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|13.41||||0.0157|TWO_SIDED|95.0|1.63|110.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||110.3|1.63|0.0157
71141637|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|3.01||||0.0846|TWO_SIDED|95.0|0.86|10.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.49|0.86|0.0846
71141638|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|5.42||||0.0171|TWO_SIDED|95.0|1.35|21.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||21.75|1.35|0.0171
71141639|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|4.71||||0.0262|TWO_SIDED|95.0|1.2|18.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||18.49|1.20|0.0262
71141640|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|1.88||||0.2858|TWO_SIDED|95.0|0.59|5.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.95|0.59|0.2858
71141641|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|7.65||||0.0155|TWO_SIDED|95.0|1.47|39.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||39.72|1.47|0.0155
71141642|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|2.66||||0.1249|TWO_SIDED|95.0|0.76|9.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||9.31|0.76|0.1249
70867193|NCT00945893|141220706|NON_INFERIORITY_OR_EQUIVALENCE|Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% CIs (Chan and Zhang, 1999) on the rate difference (monovalent vaccine minus placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.|Rate difference|-0.5|||||TWO_SIDED|95.0|-14.7|11.8|||Score|||||11.8|-14.7|
70867194|NCT00945893|141220709|NON_INFERIORITY_OR_EQUIVALENCE|Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% CIs (Chan and Zhang, 1999) on the rate difference (monovalent vaccine minus placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.|Rate difference|2.0|||||TWO_SIDED|95.0|-12.6|14.9|||Score|||||14.9|-12.6|
70867195|NCT00945893|141220718|SUPERIORITY_OR_OTHER||rate difference|5.8|||||TWO_SIDED|95.0|-7.7|13.8|||score|||The number of participants who achieved a post Dose 1 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).||13.8|-7.7|
70867196|NCT00945893|141220719|SUPERIORITY_OR_OTHER||rate difference|-6.0|||||TWO_SIDED|95.0|-23.5|5.3|||score|||The number of participants who achieved a post Dose 1 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).||5.3|-23.5|
70867197|NCT00945893|141220720|SUPERIORITY_OR_OTHER||rate difference|2.4|||||TWO_SIDED|95.0|-9.3|10.8|||score|||The number of participants who achieved a post Dose 2 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).||10.8|-9.3|
70867198|NCT01681472|141220725|SUPERIORITY|||||||0.0323|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0323
70867199|NCT01681472|141220725|SUPERIORITY|||||||0.1336|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1336
70867200|NCT01681472|141220725|SUPERIORITY|||||||0.8622|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.8622
70867201|NCT01681472|141220725|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
70867202|NCT01681472|141220725|SUPERIORITY|||||||0.0074|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0074
70867203|NCT01681472|141220725|SUPERIORITY|||||||0.1752|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1752
70867204|NCT01681472|141220726|SUPERIORITY|||||||0.148|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1480
70867205|NCT01681472|141220726|SUPERIORITY|||||||0.0034|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0034
70867206|NCT01681472|141220726|SUPERIORITY|||||||0.0177|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0177
70867207|NCT01681472|141220726|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||<0.0001
71141643|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|3.85||||0.0616|TWO_SIDED|95.0|0.94|15.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||15.82|0.94|0.0616
71141644|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|8.32||||0.0126|TWO_SIDED|95.0|1.58|43.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||43.90|1.58|0.0126
71141645|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|3.1||||0.0853|TWO_SIDED|95.0|0.85|11.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||11.23|0.85|0.0853
71141646|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|2.56||||0.1562|TWO_SIDED|95.0|0.7|9.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.35|0.70|0.1562
71141647|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|2.83||||0.1297|TWO_SIDED|95.0|0.74|10.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||10.91|0.74|0.1297
71141648|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|2.34||||0.2001|TWO_SIDED|95.0|0.64|8.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||8.55|0.64|0.2001
71141649|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|8.6||||0.0495|TWO_SIDED|95.0|1.0|73.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||73.70|1.00|0.0495
71141650|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|2.86||||0.1553|TWO_SIDED|95.0|0.67|12.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||12.20|0.67|0.1553
70867208|NCT01681472|141220726|SUPERIORITY|||||||0.0019|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0019
71141651|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|7.67||||0.0199|TWO_SIDED|95.0|1.38|42.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||42.67|1.38|0.0199
71141652|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0472|TWO_SIDED|95.0|1.02|27.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||27.34|1.02|0.0472
71141653|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|1.75||||0.3736|TWO_SIDED|95.0|0.51|5.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.98|0.51|0.3736
71141654|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|2.06||||0.2628|TWO_SIDED|95.0|0.58|7.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.26|0.58|0.2628
71141655|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|2.43||||0.1998|TWO_SIDED|95.0|0.63|9.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.39|0.63|0.1998
71141656|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|2.89||||0.1507|TWO_SIDED|95.0|0.68|12.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||12.28|0.68|0.1507
71141657|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|5.92||||0.0385|TWO_SIDED|95.0|1.1|31.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||31.94|1.10|0.0385
71141658|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|10.85||||0.0299|TWO_SIDED|95.0|1.26|93.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||93.28|1.26|0.0299
71141659|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|1.19||||0.8034|TWO_SIDED|95.0|0.3|4.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.74|0.30|0.8034
71141660|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|1.14||||0.8532|TWO_SIDED|95.0|0.29|4.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.42|0.29|0.8532
70950136|NCT01055704|141401152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.772|STANDARD_ERROR_OF_MEAN|12.583||0.889|TWO_SIDED|95.0|-23.678|27.223|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI as covariates||27.223|-23.678|0.889
70950137|NCT01055704|141401152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.607|STANDARD_ERROR_OF_MEAN|11.356||0.274|TWO_SIDED|95.0|-10.362|35.577|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||35.577|-10.362|0.274
70950138|NCT01055704|141401153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.214|STANDARD_ERROR_OF_MEAN|0.178||0.236|TWO_SIDED|95.0|-0.572|0.145|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.145|-0.572|0.236
70950139|NCT01055704|141401153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.028|STANDARD_ERROR_OF_MEAN|0.19||0.885|TWO_SIDED|95.0|-0.412|0.357|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.357|-0.412|0.885
70950140|NCT01055704|141401154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.497|STANDARD_ERROR_OF_MEAN|0.374||0.192|TWO_SIDED|95.0|-1.255|0.261|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.261|-1.255|0.192
70950141|NCT01055704|141401154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.063|STANDARD_ERROR_OF_MEAN|0.342||0.855|TWO_SIDED|95.0|-0.756|0.63|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.630|-0.756|0.855
70950142|NCT01430468|141401174|EQUIVALENCE|With use of previously established criteria for a malpositioned glenoid, deviations of greater than 10 degrees of version from the planned placement were considered relevant.||||||0.11||||||P-value was calculated. Threshold for statistical significance (p\<0.05)|t-test, 2 sided|||The absolute difference between the actual outcome and the planned outcome was compared between the standard surgical group and the glenoid positioning system group with use of a Student t test. Results were considered to be significant at p \< 0.05.||||0.11
70950143|NCT03518567|141401196|SUPERIORITY||Slope|0.78||||4e-08|TWO_SIDED||||||Regression, Linear|"hits purchased on the MPT predicting hits actually purchased and smoked in the laboratory.~covariate: baseline total individual income"||||||.00000004
70950144|NCT03518567|141401197|SUPERIORITY||Mean Difference (Final Values)|-0.75|STANDARD_DEVIATION|1.09||9e-09|TWO_SIDED||||||t-test, 2 sided|||||||.000000009
70950145|NCT03518567|141401198|SUPERIORITY||correlation|0.02||||0.87|TWO_SIDED||||||correlation|Correlation between puffs on the topography device and grams of cannabis used per week.||||||.87
71141661|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8823|TWO_SIDED|95.0|0.28|4.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.41|0.28|0.8823
70867209|NCT01681472|141220726|SUPERIORITY|||||||0.0118|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0118
70950146|NCT01151423|141401213|SUPERIORITY||Hazard Ratio (HR)|2.2|||=|0.005|TWO_SIDED|95.0|1.28|3.78||Caplacizumab was compared to placebo using a one-sided log-rank test in order to assess superiority at 2.5% significance level.|Stratified log-rank test||The HR was estimated from a Cox proportional Hazards regression model with presence (yes) / absence (no) of 1 PE session prior to randomization as covariate.|The primary analysis consisted of a Kaplan-Meier analysis with time-to-response as endpoint and treatment group as the independent variable and stratified for absence/presence of one PE session prior to randomization.||3.78|1.28|= 0.005
70867210|NCT01681472|141220727|SUPERIORITY|||||||0.1182|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1182
71141662|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|4.79||||0.1651|TWO_SIDED|95.0|0.52|43.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||43.76|0.52|0.1651
70950147|NCT00078377|141401266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8||||0.0024||95.0|1.02|4.61|||ANCOVA|The corresponding baseline value as a covariate.||Statistical data is for the Armodafinil Combined treatment (250 mg/day and 150 mg/day groups) compared to the placebo treatment group||4.61|1.02|0.0024
70950148|NCT00078377|141401267|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70950149|NCT00233480|141401268|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025|TWO_SIDED|95.0|||||paired t test|||||||0.025
70950150|NCT00581893|141401274|SUPERIORITY|||||||0.5|||||||McNemar|||||||0.50
70950151|NCT00790400|141401277|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Clopper-Pearson|||||||<0.0001
70950152|NCT02356705|141401298|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
70950153|NCT02356705|141401299|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
70950154|NCT02356705|141401300|SUPERIORITY|||||||0.88|||||||Kruskal-Wallis|||||||0.88
70950155|NCT02356705|141401302|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||||||0.01
70950156|NCT02356705|141401303|SUPERIORITY|||||||0.08|||||||Kruskal-Wallis|||||||0.08
71141663|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|6.36||||0.1048|TWO_SIDED|95.0|0.68|59.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||59.55|0.68|0.1048
70867211|NCT01681472|141220727|SUPERIORITY|||||||0.0538|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0538
70950157|NCT01107899|141401308|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for the overall effect of initial inhibition on the day to return to baseline platelet function.|Regression, Linear|||||||<0.001
70950158|NCT01107899|141401310|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|p-value was obtained from an analysis of covariance model with treatment as a fixed effect and the baseline value as a covariate.||||||<0.001
70950159|NCT01107899|141401310|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|p-value was obtained from an analysis of covariance model with treatment as a fixed effect and the baseline value as a covariate.||||||<0.001
70950160|NCT01107899|141401310|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||ANCOVA|p-value was obtained from an analysis of covariance model with treatment as a fixed effect and the baseline value as a covariate.||||||0.025
70950161|NCT01810939|141401369|SUPERIORITY_OR_OTHER_LEGACY||Proportion|0.76|||||TWO_SIDED|95.0|0.7|0.81||||||||0.81|0.7|
70950162|NCT01810939|141401370|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mantel Haenszel|||Test for difference between treatment groups in proportion with serum potassium ≥ 5.5 mEq/L||||<0.001
70950163|NCT01810939|141401371|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mantel Haenszel|||Test for difference between treatment groups in proportion with serum potassium ≥ 5.1 mEq/L||||<0.001
70950164|NCT01810939|141401372|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Longitudinal mixed models|Test that the mean change is significantly different from zero.||Estimation of mean change in serum potassium from Part A Baseline to Part A Week 4 and test mean change different from zero.||||<0.001
70950165|NCT01810939|141401373|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Test for difference between treatment groups in serum potassium change in Part B||||< 0.001
70950166|NCT02349152|141401380|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG\>180 mg/dl) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha= 0.05) between the groups. A total of 116 patients were recruited to allow for dropouts.|Risk Ratio (RR)|1.9||||0.001|TWO_SIDED|95.0|1.3|3.0|||Chi-squared|||The null hypothesis that there was no difference in the percentage of patients with two or more blood glucose values greater than 180mg/dl between the two groups. Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG\>180 mg/dl) to an absolute value of 20%.||3.0|1.3|0.001
70950167|NCT02349152|141401381|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.004|||||||t-test, 2 sided|||||||0.004
70950168|NCT02349152|141401382|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG\>180 mg/dl) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha= 0.05) between the groups. A total of 116 patients were recruited to allow for dropouts.||||||0.01|||||||Fisher Exact|||||||0.01
70950169|NCT02349152|141401383|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.0001|||||||t-test, 2 sided|||Mean Intraoperative Blood Glucose||||0.0001
70950170|NCT02349152|141401383|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.0003|||||||t-test, 2 sided|||Peak Intraoperative Blood Glucose||||0.0003
71141664|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|5.87||||0.1168|TWO_SIDED|95.0|0.64|53.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||53.53|0.64|0.1168
70950171|NCT02349152|141401383|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.98|||||||t-test, 2 sided|||Lowest Intraoperative Blood Glucose||||0.98
70950172|NCT02349152|141401384|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.14|||||||t-test, 2 sided|||Mean post-operative glucose||||0.14
70950173|NCT02349152|141401384|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.25|||||||t-test, 2 sided|||Peak Postoperative Blood Glucose||||0.25
70950174|NCT02349152|141401385|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.49|||||||t-test, 2 sided|||||||0.49
71141665|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|1.31||||0.6936|TWO_SIDED|95.0|0.35|4.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.95|0.35|0.6936
71141666|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|1.74||||0.4315|TWO_SIDED|95.0|0.44|6.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.90|0.44|0.4315
71141667|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|1.19||||0.7936|TWO_SIDED|95.0|0.31|4.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.53|0.31|0.7936
71141668|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|6.3||||0.099|TWO_SIDED|95.0|0.71|56.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||56.03|0.71|0.0990
70867212|NCT01681472|141220727|SUPERIORITY|||||||0.5244|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.5244
70950175|NCT02349152|141401387|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.401|||||||t-test, 2 sided|||Prebypass||||0.401
70950176|NCT02349152|141401387|NON_INFERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||30 minutes after the start of CPB||||<0.0001
70950177|NCT02349152|141401387|NON_INFERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||End of CPB||||<0.0001
71141669|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|5.86||||0.1128|TWO_SIDED|95.0|0.66|52.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||52.21|0.66|0.1128
71141670|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|7.36||||0.0732|TWO_SIDED|95.0|0.83|65.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||65.38|0.83|0.0732
71141671|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|1.39||||0.6559|TWO_SIDED|95.0|0.33|5.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.91|0.33|0.6559
71141672|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|0.8||||0.7333|TWO_SIDED|95.0|0.21|2.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||2.96|0.21|0.7333
71141673|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|0.94||||0.9266|TWO_SIDED|95.0|0.24|3.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.74|0.24|0.9266
71141674|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|5.04||||0.1518|TWO_SIDED|95.0|0.55|46.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||46.13|0.55|0.1518
71141675|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|4.69||||0.1714|TWO_SIDED|95.0|0.51|42.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||42.91|0.51|0.1714
71141676|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|5.6||||0.1299|TWO_SIDED|95.0|0.6|51.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||51.95|0.60|0.1299
71141677|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|2.75||||0.2495|TWO_SIDED|95.0|0.49|15.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||15.44|0.49|0.2495
71141678|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|1.32||||0.7065|TWO_SIDED|95.0|0.31|5.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.60|0.31|0.7065
71141679|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|1.26||||0.7504|TWO_SIDED|95.0|0.3|5.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.24|0.30|0.7504
71141680|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|0.83||||0.7862|TWO_SIDED|95.0|0.21|3.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.29|0.21|0.7862
71141681|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|4.98||||0.155|TWO_SIDED|95.0|0.54|45.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||45.59|0.54|0.1550
71141682|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|4.7||||0.1706|TWO_SIDED|95.0|0.51|42.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||42.96|0.51|0.1706
71141683|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|5.31||||0.1415|TWO_SIDED|95.0|0.57|49.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||49.11|0.57|0.1415
71141684|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|5.67||||0.1241|TWO_SIDED|95.0|0.62|51.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||51.74|0.62|0.1241
70867213|NCT01681472|141220727|SUPERIORITY|||||||0.0081|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0081
71141685|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|2.64||||0.2169|TWO_SIDED|95.0|0.57|12.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||12.29|0.57|0.2169
71141686|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9982|TWO_SIDED|95.0|0.28|3.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.60|0.28|0.9982
71141687|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|1.57||||0.5364|TWO_SIDED|95.0|0.38|6.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.54|0.38|0.5364
71141688|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|5.68||||0.121|TWO_SIDED|95.0|0.63|51.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||51.07|0.63|0.1210
71141689|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|7.65||||0.0726|TWO_SIDED|95.0|0.83|70.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||70.58|0.83|0.0726
71141690|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|7.34||||0.0749|TWO_SIDED|95.0|0.82|65.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||65.81|0.82|0.0749
70867214|NCT01681472|141220727|SUPERIORITY|||||||0.0313|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0313
70867215|NCT01681472|141220727|SUPERIORITY|||||||0.4777|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.4777
70867216|NCT01681472|141220728|SUPERIORITY|||||||0.2716|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.2716
70867217|NCT01681472|141220728|SUPERIORITY|||||||0.0124|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0124
70867218|NCT01681472|141220728|SUPERIORITY|||||||0.0728|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0728
70867219|NCT01681472|141220728|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||<0.0001
70867220|NCT01681472|141220728|SUPERIORITY|||||||0.0039|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0039
70867221|NCT01681472|141220728|SUPERIORITY|||||||0.0454|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0454
70867222|NCT01681472|141220729|SUPERIORITY|||||||0.0092|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0092
70867223|NCT01681472|141220729|SUPERIORITY|||||||0.8303|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.8303
70867224|NCT01681472|141220729|SUPERIORITY|||||||0.1182|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1182
70867225|NCT01681472|141220729|SUPERIORITY|||||||0.0081|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0081
70867226|NCT01681472|141220729|SUPERIORITY|||||||0.3184|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.3184
70867227|NCT01681472|141220729|SUPERIORITY|||||||0.1752|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1752
70867228|NCT01681472|141220730|SUPERIORITY|||||||0.0728|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0728
70867229|NCT01681472|141220730|SUPERIORITY|||||||0.2246|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.2246
70867230|NCT01681472|141220730|SUPERIORITY|||||||0.0428|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0428
70867231|NCT01681472|141220730|SUPERIORITY|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0003
70867232|NCT01681472|141220730|SUPERIORITY|||||||0.4309|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.4309
70867233|NCT01681472|141220730|SUPERIORITY|||||||0.0055|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0055
70867234|NCT01681472|141220731|SUPERIORITY|||||||0.0728|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0728
70867235|NCT01681472|141220731|SUPERIORITY|||||||0.0034|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0034
70867236|NCT01681472|141220731|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
70867237|NCT01681472|141220731|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
70867238|NCT01681472|141220731|SUPERIORITY|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0009
70867239|NCT01681472|141220731|SUPERIORITY|||||||0.0055|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0055
70867240|NCT01681472|141220732|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0240
70867241|NCT01681472|141220732|SUPERIORITY|||||||0.0058|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0058
70867242|NCT01681472|141220732|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
70867243|NCT01681472|141220732|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||<0.0001
70867244|NCT01681472|141220732|SUPERIORITY|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0014
70867245|NCT01681472|141220732|SUPERIORITY|||||||0.0338|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0338
70867246|NCT01681472|141220733|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867247|NCT01681472|141220733|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867248|NCT01681472|141220733|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867249|NCT01681472|141220733|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867250|NCT01681472|141220733|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
70867251|NCT01681472|141220733|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867252|NCT01681472|141220734|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
70867253|NCT01681472|141220734|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867254|NCT01681472|141220734|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
70867255|NCT01681472|141220734|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71141691|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|4.01||||0.053|TWO_SIDED|95.0|0.98|16.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||16.35|0.98|0.0530
70950178|NCT02349152|141401387|NON_INFERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||End of Surgery||||<0.0001
70867256|NCT01681472|141220734|SUPERIORITY|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0009
70867257|NCT01681472|141220734|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867258|NCT01681472|141220735|SUPERIORITY|||||||0.0728|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0728
70867259|NCT01681472|141220735|SUPERIORITY|||||||0.2246|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.2246
70867260|NCT01681472|141220735|SUPERIORITY|||||||0.0166|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0166
70867261|NCT01681472|141220735|SUPERIORITY|||||||0.1752|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1752
70867262|NCT01681472|141220735|SUPERIORITY|||||||0.9581|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.9581
70867263|NCT01681472|141220735|SUPERIORITY|||||||0.0118|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0118
70867264|NCT01681472|141220736|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867265|NCT01681472|141220736|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867266|NCT01681472|141220736|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70950179|NCT02349152|141401387|NON_INFERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.021|||||||t-test, 2 sided|||Postoperative (8 hours)||||0.021
70867267|NCT01681472|141220736|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867268|NCT01681472|141220736|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867269|NCT01681472|141220736|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
70867270|NCT01681472|141220737|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
70867271|NCT01681472|141220737|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867272|NCT01681472|141220737|SUPERIORITY|||||||0.0022|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0022
70867273|NCT01681472|141220737|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867274|NCT01681472|141220737|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
70867275|NCT01681472|141220737|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70950180|NCT02349152|141401388|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.58|||||||t-test, 2 sided|||Analyzing the IL-1b Pre bypass||||0.580
70950181|NCT02349152|141401388|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.815|||||||t-test, 2 sided|||Analyzing the IL-1b CPB-30||||0.815
70950182|NCT02349152|141401388|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.715|||||||t-test, 2 sided|||Analyzing the CPB-END||||0.715
70950183|NCT02349152|141401388|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.33|||||||t-test, 2 sided|||Analyzing the IL-1b post-bypass||||0.330
70950184|NCT02349152|141401388|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.651|||||||t-test, 2 sided|||Analyzing the IL-1b 8 HR||||0.651
70950185|NCT02349152|141401388|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.439|||||||t-test, 2 sided|||Analyzing the IL-6 Pre bypass||||0.439
70950186|NCT02349152|141401388|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.284|||||||t-test, 2 sided|||Analyzing the IL-6 CPB-30||||0.284
71141692|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|2.32||||0.2134|TWO_SIDED|95.0|0.62|8.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||8.72|0.62|0.2134
70950187|NCT02349152|141401388|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.779|||||||t-test, 2 sided|||Analyzing the CPB-END||||0.779
70950188|NCT02349152|141401388|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.274|||||||t-test, 2 sided|||Analyzing the IL-6 post-bypass||||0.274
70950189|NCT02349152|141401388|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.601|||||||t-test, 2 sided|||Analyzing the IL-6 8HR||||0.601
70950190|NCT02349152|141401388|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.315|||||||t-test, 2 sided|||Analyzing the TNFa Pre-bypass||||0.315
70950191|NCT02349152|141401388|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.062|||||||t-test, 2 sided|||Analyzing the TNFa CPB-30||||0.062
70950192|NCT02349152|141401388|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.09|||||||t-test, 2 sided|||Analyzing the TNFa CPB-END||||0.090
70950193|NCT02349152|141401388|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.004|||||||t-test, 2 sided|||Analyzing the TNFa- post-bypass||||0.004
70950194|NCT02349152|141401388|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.074|||||||t-test, 2 sided|||Analyzing the TNFa-8HR||||0.074
71141693|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|1.88||||0.3688|TWO_SIDED|95.0|0.48|7.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.41|0.48|0.3688
70950195|NCT02349152|141401389|NON_INFERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.74|||||||t-test, 2 sided|||Analyzing the ACTH Pre-bypass group||||0.740
70950196|NCT02349152|141401389|NON_INFERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||Analyzing the ACTH CPB-30 group.||||<0.0001
70950197|NCT02349152|141401389|NON_INFERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||Analyzing the ACTH CPB-END||||<0.0001
70950198|NCT02349152|141401389|NON_INFERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||Analyzing the ACTH post-bypass||||<0.0001
70950199|NCT02349152|141401389|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.014|||||||t-test, 2 sided|||Analyzing the ACTH 8-hr||||0.014
70950200|NCT02349152|141401389|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.1|||||||t-test, 2 sided|||Analyzing the GH- Pre-bypass||||0.100
70950201|NCT02349152|141401389|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||GH-CPB-30||||<0.0001
70950202|NCT02349152|141401389|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.009|||||||t-test, 2 sided|||Analyzing the GH-CPB-END||||0.009
70950203|NCT02349152|141401389|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.046|||||||t-test, 2 sided|||GH-Post-bypass||||0.046
70950204|NCT02349152|141401389|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.695|||||||t-test, 2 sided|||Analyzing the GH-8-hr||||0.695
70950205|NCT02349152|141401389|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.455|||||||t-test, 2 sided|||Analyzing the Glucagon Pre Bypass||||0.455
70950206|NCT02349152|141401389|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.059|||||||t-test, 2 sided|||Analyzing the Glucagon CPB-30||||0.059
70950207|NCT02349152|141401389|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.175|||||||t-test, 2 sided|||Analyzing the Glucagon CPB-END||||0.175
70950208|NCT02349152|141401389|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.062|||||||t-test, 2 sided|||Analyzing the Glucagon Post-bypass||||0.062
70950209|NCT02349152|141401389|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.261|||||||t-test, 2 sided|||Analyzing the Glucagon 8-hr||||0.261
70950210|NCT02349152|141401390|SUPERIORITY|||||||0.06|||||||Chi-squared|||30-day mortality||||0.06
70867276|NCT01681472|141220738|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
70950211|NCT02349152|141401390|SUPERIORITY|||||||0.03|||||||Chi-squared|||30-day readmission||||0.03
70950212|NCT02349152|141401390|SUPERIORITY|||||||0.24|||||||Chi-squared|||Cerebral Vascular Accident||||0.24
70950213|NCT02349152|141401390|SUPERIORITY|||||||0.93|||||||Chi-squared|||Prolonged Mechanical Ventilation||||0.93
70950214|NCT02349152|141401390|SUPERIORITY|||||||1|||||||Chi-squared|||Renal Failure||||1
70950215|NCT02349152|141401390|SUPERIORITY|||||||0.1|||||||Chi-squared|||Atrial Fibrillation||||0.10
70950216|NCT02349152|141401390|SUPERIORITY|||||||1|||||||Chi-squared|||cardiac arrest||||1
70950217|NCT02349152|141401391|SUPERIORITY|||||||0.205|||||||t-test, 2 sided|||Hrs 0-6||||0.205
70950218|NCT02349152|141401391|SUPERIORITY|||||||0.339|||||||t-test, 2 sided|||Hrs 7-12||||0.339
70950219|NCT02349152|141401391|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||Hrs 13-18||||0.006
70950220|NCT02349152|141401391|SUPERIORITY|||||||0.747|||||||t-test, 2 sided|||Hrs 19-24||||0.747
70950221|NCT02349152|141401391|SUPERIORITY|||||||0.568|||||||t-test, 2 sided|||Hrs 25-30||||0.568
70950222|NCT02349152|141401391|SUPERIORITY|||||||0.924|||||||t-test, 2 sided|||Hrs 31-36||||0.924
70950223|NCT02349152|141401391|SUPERIORITY|||||||0.501|||||||t-test, 2 sided|||Hrs 37-42||||0.501
70950224|NCT02349152|141401391|SUPERIORITY|||||||0.977|||||||t-test, 2 sided|||Hrs 43-48||||0.977
70950225|NCT02349152|141401395|SUPERIORITY|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.350
70950226|NCT01634269|141401397|SUPERIORITY_OR_OTHER_LEGACY||Proportion of IF implanted subjects|87.5||||0.002|TWO_SIDED|95.0|61.7|98.4|||Exact binomial|||||98.4|61.7|0.002
70950227|NCT01607879|141401464|SUPERIORITY|||||||0.1497|||||||t-test, 1 sided|||||||0.1497
70950228|NCT01607879|141401465|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
70950229|NCT01607879|141401466|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||||||0.75
70950230|NCT01607879|141401467|SUPERIORITY|||||||0.925|||||||Wilcoxon (Mann-Whitney)|||||||0.925
70950231|NCT01607879|141401468|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
70950232|NCT00706654|141401489|NON_INFERIORITY_OR_EQUIVALENCE|The test of non-inferiority of was performed using a 95% confidence interval (CI, 2-sided) for the difference in the estimated percentage of patients meeting exacerbation of psychotic symptoms/impending relapse criteria by the end of Week 26. Non-inferiority was considered confirmed if the upper bound of the 2-sided 95% CI was below the predefined margin, 11.5%.|Mean Difference (Final Values)|-0.64||||0.7871|TWO_SIDED|95.0|-5.26|3.99|||z-statistics||The 95% CI of the difference in proportions of subjects with impending relapse events between aripiprazole IM depot 300 or 400 mg mg and oral aripiprazole were provided using the pooled SE with assumption of normality of the estimated difference.|Sample sizes were estimated to achieve 93% power for the primary non-inferiority 2-sided comparison at 0.05 significance using large sample normal approximations for the distribution of the difference in binomial proportions. The assumed proportion of impending relapse at or before Week 26 for the oral aripiprazole 10-30 mg arm was 18% and the predefined non-inferiority margin was 11.5%. The sample size was projected to be 260 each for the IM depot 300 or 400 mg and oral 10-30 mg arms.||3.99|-5.26|0.7871
70950233|NCT00706654|141401489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.68||||0.0006|TWO_SIDED|95.0|-23.09|-6.27||Once non-inferiority was declared, superiority of depot 300/400 mg over depot 25/50 mg was tested by the difference between the proportion of subjects experiencing impending relapse by the end of Week 26 (2-sided 0.05 significance level z-statistic).|z-statistics|The same method was used to compare IM depot 300 or 400 mg with IM depot 25 or 50 mg in the estimated proportion of subjects with impending relapse.||For the superiority comparison (assay sensitivity analysis) of IM depot 300 or 400 mg to IM depot 25 or 50 mg, on a 2:1 randomization, sample sizes of 260 and 130, respectively, were calculated to provide about 95% power at the 0.05 significance level (2-sided). A superiority margin of 17% was assumed.||-6.27|-23.09|0.0006
70950234|NCT00706654|141401491|SUPERIORITY_OR_OTHER|||||||0.875||95.0|||||z-statistics|||||||0.8750
70950235|NCT00706654|141401491|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||z-statistics|||||||0.0001
70867277|NCT01681472|141220738|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867278|NCT01681472|141220738|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
70867279|NCT01681472|141220738|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867280|NCT01681472|141220738|SUPERIORITY|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0009
70867281|NCT01681472|141220738|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867282|NCT01681472|141220739|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0240
70950236|NCT00706654|141401492|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||z-statistics|||||||0.3700
71141694|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|4.61||||0.0563|TWO_SIDED|95.0|0.96|22.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||22.11|0.96|0.0563
71141695|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|3.94||||0.0935|TWO_SIDED|95.0|0.79|19.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||19.52|0.79|0.0935
71141696|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|3.71||||0.0901|TWO_SIDED|95.0|0.81|16.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||16.93|0.81|0.0901
71141697|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|2.84||||0.1366|TWO_SIDED|95.0|0.72|11.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||11.26|0.72|0.1366
71141698|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|1.19||||0.7876|TWO_SIDED|95.0|0.34|4.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.08|0.34|0.7876
71141699|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|1.59||||0.4658|TWO_SIDED|95.0|0.45|5.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.59|0.45|0.4658
71141700|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8707|TWO_SIDED|95.0|0.25|3.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.20|0.25|0.8707
71141701|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|1.89||||0.3584|TWO_SIDED|95.0|0.49|7.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||7.36|0.49|0.3584
71141702|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|3.13||||0.1455|TWO_SIDED|95.0|0.67|14.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||14.57|0.67|0.1455
71141703|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|5.07||||0.0661|TWO_SIDED|95.0|0.9|28.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||28.66|0.90|0.0661
71141704|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|1.97||||0.3034|TWO_SIDED|95.0|0.54|7.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||7.17|0.54|0.3034
70950237|NCT00706654|141401492|SUPERIORITY_OR_OTHER|||||||0.1097||95.0|||||z-statistics|||||||0.1097
71141705|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9901|TWO_SIDED|95.0|0.28|3.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.60|0.28|0.9901
71141706|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|1.55||||0.507|TWO_SIDED|95.0|0.42|5.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.68|0.42|0.5070
71141707|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|0.83||||0.7927|TWO_SIDED|95.0|0.21|3.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.26|0.21|0.7927
71141708|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|1.71||||0.4426|TWO_SIDED|95.0|0.44|6.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||6.69|0.44|0.4426
71141709|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|0.91||||0.8925|TWO_SIDED|95.0|0.23|3.56||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.56|0.23|0.8925
71141710|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|1.79||||0.4285|TWO_SIDED|95.0|0.42|7.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||7.52|0.42|0.4285
71141711|NCT03192176|141778537|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9|TWO_SIDED|95.0|0.31|3.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.72|0.31|0.9000
71141712|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0602|TWO_SIDED|95.0|0.96|6.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||6.06|0.96|0.0602
71141713|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|4.88||||0.001|TWO_SIDED|95.0|1.89|12.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||12.57|1.89|0.0010
71141714|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|5.24||||0.0006|TWO_SIDED|95.0|2.03|13.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||13.51|2.03|0.0006
71141715|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|9.07|||<|0.0001|TWO_SIDED|95.0|3.23|25.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||25.45|3.23|<0.0001
71141716|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|2.06||||0.1259|TWO_SIDED|95.0|0.82|5.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||5.22|0.82|0.1259
71141717|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|7.05|||<|0.0001|TWO_SIDED|95.0|2.65|18.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||18.71|2.65|<0.0001
71141718|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|3.51||||0.007|TWO_SIDED|95.0|1.41|8.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||8.76|1.41|0.0070
70950238|NCT00594022|141401494|SUPERIORITY_OR_OTHER|||||||0.1275|||||||t-test, 1 sided|||||||.1275
71141719|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|3.15||||0.0193|TWO_SIDED|95.0|1.2|8.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.23|1.20|0.0193
71141720|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|3.34||||0.0148|TWO_SIDED|95.0|1.27|8.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.81|1.27|0.0148
71141721|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|5.05||||0.0018|TWO_SIDED|95.0|1.83|13.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||13.94|1.83|0.0018
71141722|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|7.27||||0.0007|TWO_SIDED|95.0|2.32|22.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||22.78|2.32|0.0007
70867283|NCT01681472|141220739|SUPERIORITY|||||||0.1336|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1336
70867284|NCT01681472|141220739|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
70867285|NCT01681472|141220739|SUPERIORITY|||||||0.2725|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.2725
70867286|NCT01681472|141220739|SUPERIORITY|||||||0.1893|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1893
70867287|NCT01681472|141220739|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
70867288|NCT01681472|141220740|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867289|NCT01681472|141220740|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867290|NCT01681472|141220740|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867291|NCT01681472|141220740|SUPERIORITY|||||||0.0142|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0142
70950239|NCT01151215|141401519|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.485|TWO_SIDED|95.0|0.77|1.75||Statistical significance threshold at this interim analysis was 5%|Log Rank|The log rank test was stratified for the IVRS stratification factor of disease classification (locally advanced / metastatic disease)|The Hazard Ratio is for AZD8931 40mg + anastrozole 1mg / Placebo + anastrozole 1mg, ie a hazard ratio \<1 favours AZD8931 40mg + anastrozole 1mg|345 patients were to be randomised to observe at least 233 progression events, based on HR=0.60, 90% power, 2-sided 5% significant level and a median of 9 months for the placebo arm. An interim analysis with futility boundary was introduced based on an IDMC recommendation.||1.75|0.77|0.485
70950240|NCT01151215|141401519|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.37||||0.135|TWO_SIDED|95.0|0.91|2.06|||Log Rank|The log rank test was stratified for the IVRS stratification factor of disease classification (locally advanced / metastatic disease)|The Hazard ratio is for AZD8931 20mg + anastrozole 1mg / Placebo + anastrozole 1mg, ie a hazard ratio \< 1 favours AZD8931 20mg + anastrozole 1mg|345 patients were to be randomised to observe at least 233 progression events, based on HR=0.6, 90% power, 2-sided 5% significant level and a median of 9 months for the placebo arm. An interim analysis with futility boundary was introduced based on an IDMC recommendation.||2.06|0.91|0.135
70867292|NCT01681472|141220740|SUPERIORITY|||||||0.0085|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0085
70867293|NCT01681472|141220740|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
70867294|NCT01681472|141220741|SUPERIORITY|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0014
70867295|NCT01681472|141220741|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70950241|NCT01721954|141401521|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.43|TWO_SIDED|95.0|||||Log Rank|||The null hypothesis tested for the primary efficacy endpoint is overall survival (months) of SIRT/FOLFOX treatment versus FOLFOX is equal for both groups. The two-sided alternative hypothesis tested with 95% confidence is OS time for SIRT/FOLFOX treatment lower to that of FOLFOX.||||0.43
70950242|NCT01721954|141401522|SUPERIORITY||Hazard Ratio (HR)|0.75|||<|0.05|TWO_SIDED||||||Log Rank|||A sample size of at least 209 patients for the SIRFLOX study was estimated to be needed to detect an increase in the median PFS at any site from 9.4 months to 14.5 months with 80% power and 95% confidence. Taking into account the number of patients who might receive the alternative treatment or lack of imaging data, the sample size was increased to 209. The Null hypothesis is no difference between the treatment arms with respect to PFS.||||<0.05
70950243|NCT03274895|141401569|NON_INFERIORITY|Non-inferiority margin= 0.20|difference in proportion of resolution r|-0.036|||||TWO_SIDED|95.0|-0.154|0.081||||||||0.081|-0.154|
70867296|NCT01681472|141220741|SUPERIORITY|||||||0.0021|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0021
70867297|NCT01681472|141220741|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867298|NCT01681472|141220741|SUPERIORITY|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0014
71141723|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|3.11||||0.0246|TWO_SIDED|95.0|1.16|8.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.35|1.16|0.0246
70867299|NCT01681472|141220741|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867300|NCT01681472|141220742|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
70867301|NCT01681472|141220742|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867302|NCT01681472|141220742|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
70867303|NCT01681472|141220742|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867304|NCT01681472|141220742|SUPERIORITY|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0009
70867305|NCT01681472|141220742|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867306|NCT01681472|141220743|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0240
70867307|NCT01681472|141220743|SUPERIORITY|||||||0.1336|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1336
70867308|NCT01681472|141220743|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
70867309|NCT01681472|141220743|SUPERIORITY|||||||0.1551|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1551
70867310|NCT01681472|141220743|SUPERIORITY|||||||0.1563|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1563
70867311|NCT01681472|141220743|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
70867312|NCT01681472|141220744|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867313|NCT01681472|141220744|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867314|NCT01681472|141220744|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867315|NCT01681472|141220744|SUPERIORITY|||||||0.0142|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0142
70867316|NCT01681472|141220744|SUPERIORITY|||||||0.0085|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0085
70867317|NCT01681472|141220744|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
70867318|NCT01681472|141220745|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||1.0000
70867319|NCT01681472|141220745|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867320|NCT01681472|141220745|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0010
70950244|NCT03274895|141401570|OTHER|||||||0.042|||||||Log Rank|||||||0.042
70950245|NCT03274895|141401571|OTHER|||||||0.577|||||||ANCOVA|||||||0.577
71141724|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|5.22||||0.0016|TWO_SIDED|95.0|1.87|14.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||14.60|1.87|0.0016
70867321|NCT01681472|141220745|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867322|NCT01681472|141220745|SUPERIORITY|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0005
70867323|NCT01681472|141220745|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867324|NCT01681472|141220746|SUPERIORITY|||||||0.0056|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0056
70867325|NCT01681472|141220746|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867326|NCT01681472|141220746|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0010
70867327|NCT01681472|141220746|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867328|NCT01681472|141220746|SUPERIORITY|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0014
70867329|NCT01681472|141220746|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867330|NCT01681472|141220747|SUPERIORITY|||||||0.1796|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1796
70867331|NCT01681472|141220747|SUPERIORITY|||||||0.3243|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.3243
70867332|NCT01681472|141220747|SUPERIORITY|||||||0.0263|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0263
70867333|NCT01681472|141220747|SUPERIORITY|||||||0.0268|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0268
70867334|NCT01681472|141220747|SUPERIORITY|||||||0.2041|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.2041
71141725|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|2.25||||0.0825|TWO_SIDED|95.0|0.9|5.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.62|0.90|0.0825
70867335|NCT01681472|141220747|SUPERIORITY|||||||0.0061|||||||Wilcoxon (Mann-Whitney)|||||||0.0061
70867336|NCT01681472|141220748|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867337|NCT01681472|141220748|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867338|NCT01681472|141220748|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867339|NCT01681472|141220748|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867340|NCT01681472|141220748|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867341|NCT01681472|141220748|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70950246|NCT05672771|141401589|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.355|TWO_SIDED||||||ANOVA|||||||0.355
71141726|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|2.66||||0.0542|TWO_SIDED|95.0|0.98|7.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.20|0.98|0.0542
71141727|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|2.38||||0.0837|TWO_SIDED|95.0|0.89|6.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.33|0.89|0.0837
71141728|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|3.67||||0.0131|TWO_SIDED|95.0|1.31|10.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.26|1.31|0.0131
71141729|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|9.34||||0.0012|TWO_SIDED|95.0|2.41|36.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||36.19|2.41|0.0012
71141730|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|3.1||||0.0359|TWO_SIDED|95.0|1.08|8.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.93|1.08|0.0359
71141731|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|5.86||||0.0019|TWO_SIDED|95.0|1.91|17.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||17.92|1.91|0.0019
71141732|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0715|TWO_SIDED|95.0|0.93|6.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.38|0.93|0.0715
71141733|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|2.89||||0.0465|TWO_SIDED|95.0|1.02|8.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.20|1.02|0.0465
71141734|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0839|TWO_SIDED|95.0|0.89|6.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.53|0.89|0.0839
71141735|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|3.56||||0.0191|TWO_SIDED|95.0|1.23|10.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.28|1.23|0.0191
71141736|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|12.11||||0.0019|TWO_SIDED|95.0|2.52|58.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||58.22|2.52|0.0019
71141737|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|2.76||||0.0593|TWO_SIDED|95.0|0.96|7.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.90|0.96|0.0593
71141738|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|4.95||||0.0048|TWO_SIDED|95.0|1.63|15.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||15.04|1.63|0.0048
71141739|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|2.75||||0.0494|TWO_SIDED|95.0|1.0|7.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.57|1.00|0.0494
71141740|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|2.15||||0.1887|TWO_SIDED|95.0|0.69|6.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.70|0.69|0.1887
71141741|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|3.06||||0.0717|TWO_SIDED|95.0|0.91|10.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||10.7|0.91|0.0717
71141742|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|2.43||||0.1419|TWO_SIDED|95.0|0.74|7.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.92|0.74|0.1419
71141743|NCT03192176|141778538|SUPERIORITY|0.0141|Odds Ratio (OR)|14.37||||0.0141|TWO_SIDED|95.0|1.71|120.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||120.6|1.71|0.0141
71141744|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|3.19||||0.0775|TWO_SIDED|95.0|0.88|11.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||11.54|0.88|0.0775
71141745|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|4.35||||0.0283|TWO_SIDED|95.0|1.17|16.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||16.19|1.17|0.0283
71141746|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|2.21||||0.1767|TWO_SIDED|95.0|0.7|6.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.96|0.70|0.1767
71141747|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|2.2||||0.1675|TWO_SIDED|95.0|0.72|6.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.72|0.72|0.1675
71141748|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|1.84||||0.2717|TWO_SIDED|95.0|0.62|5.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.49|0.62|0.2717
71141749|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|2.4||||0.1367|TWO_SIDED|95.0|0.76|7.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.64|0.76|0.1367
71141750|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|13.53||||0.0162|TWO_SIDED|95.0|1.62|113.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||113.0|1.62|0.0162
71141751|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|3.23||||0.0765|TWO_SIDED|95.0|0.88|11.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||11.78|0.88|0.0765
71141752|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|7.8||||0.0061|TWO_SIDED|95.0|1.79|33.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||33.87|1.79|0.0061
71141753|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|5.4||||0.0181|TWO_SIDED|95.0|1.33|21.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||21.85|1.33|0.0181
71141754|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|1.63||||0.3925|TWO_SIDED|95.0|0.53|4.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.99|0.53|0.3925
71141755|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|1.66||||0.374|TWO_SIDED|95.0|0.54|5.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.12|0.54|0.3740
71141756|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|2.33||||0.1753|TWO_SIDED|95.0|0.69|7.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.93|0.69|0.1753
71141757|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|12.85||||0.0195|TWO_SIDED|95.0|1.51|109.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||109.5|1.51|0.0195
71141758|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|2.29||||0.1932|TWO_SIDED|95.0|0.66|8.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||8.02|0.66|0.1932
70950247|NCT05672771|141401590|SUPERIORITY||Mean Difference (Final Values)|0.56|||<|0.02|TWO_SIDED||||||ANOVA||This is the difference between the Different Mixed and Placebo Control conditions.|||||<.02
70867342|NCT01681472|141220749|SUPERIORITY|||||||0.0268|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0268
70867343|NCT01681472|141220749|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867344|NCT01681472|141220749|SUPERIORITY|||||||0.0227|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0227
70950248|NCT05672771|141401591|OTHER||||||<|0.05||||||for contrasts of DM, DS, and ST groups relative to the PC group.|Mixed Models Analysis|||||||<.05
70950249|NCT00760747|141401592|SUPERIORITY_OR_OTHER||Least square mean differences at week 10|-0.7|STANDARD_ERROR_OF_MEAN|1.7||0.692|TWO_SIDED|95.0|-4.0|2.6|||Mixed Models Analysis|||||2.6|-4.0|0.692
71141759|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|3.55||||0.0537|TWO_SIDED|95.0|0.98|12.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||12.86|0.98|0.0537
71141760|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|7.72||||0.0144|TWO_SIDED|95.0|1.5|39.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||39.66|1.50|0.0144
71141761|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|1.29||||0.666|TWO_SIDED|95.0|0.41|4.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.09|0.41|0.6660
71141762|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|1.16||||0.7923|TWO_SIDED|95.0|0.37|3.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.62|0.37|0.7923
71141763|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|1.73||||0.3796|TWO_SIDED|95.0|0.51|5.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.90|0.51|0.3796
71141764|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|4.2||||0.0874|TWO_SIDED|95.0|0.81|21.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||21.73|0.81|0.0874
71141765|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|2.6||||0.1925|TWO_SIDED|95.0|0.62|10.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||10.96|0.62|0.1925
71141766|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|3.99||||0.0651|TWO_SIDED|95.0|0.92|17.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||17.38|0.92|0.0651
71141767|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|1.46||||0.5361|TWO_SIDED|95.0|0.44|4.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.81|0.44|0.5361
71141768|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|1.33||||0.6258|TWO_SIDED|95.0|0.42|4.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.17|0.42|0.6258
71141769|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|1.32||||0.6275|TWO_SIDED|95.0|0.43|4.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.06|0.43|0.6275
71141770|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|2.21||||0.2212|TWO_SIDED|95.0|0.62|7.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||7.90|0.62|0.2212
71141771|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|11.13||||0.028|TWO_SIDED|95.0|1.3|95.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||95.49|1.30|0.0280
71141772|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|4.88||||0.0589|TWO_SIDED|95.0|0.94|25.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||25.32|0.94|0.0589
71141773|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|3.63||||0.0799|TWO_SIDED|95.0|0.86|15.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||15.39|0.86|0.0799
70950250|NCT00760747|141401593|SUPERIORITY_OR_OTHER||Least square mean differences at week 10|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.456|TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|||||0.7|-0.3|0.456
70950251|NCT00760747|141401594|SUPERIORITY_OR_OTHER||Least square mean differences at week 10|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.517|TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|||||0.7|-0.3|0.517
70950252|NCT00760747|141401595|SUPERIORITY_OR_OTHER||Least square mean differences at week 10|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.526|TWO_SIDED|95.0|-0.3|0.6|||Mixed Models Analysis|||||0.6|-0.3|0.526
71141774|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|2.91||||0.1112|TWO_SIDED|95.0|0.78|10.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||10.87|0.78|0.1112
71141775|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|2.76||||0.0959|TWO_SIDED|95.0|0.84|9.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||9.11|0.84|0.0959
71141776|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|1.62||||0.3886|TWO_SIDED|95.0|0.54|4.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.85|0.54|0.3886
71141777|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|3.0||||0.0864|TWO_SIDED|95.0|0.85|10.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.52|0.85|0.0864
71141778|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|14.22||||0.0145|TWO_SIDED|95.0|1.69|119.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||119.5|1.69|0.0145
71141779|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|13.08||||0.018|TWO_SIDED|95.0|1.56|110.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||110.0|1.56|0.0180
71141780|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|18.53||||0.008|TWO_SIDED|95.0|2.14|160.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||160.6|2.14|0.0080
71141781|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|5.07||||0.0236|TWO_SIDED|95.0|1.24|20.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||20.65|1.24|0.0236
71141782|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|1.59||||0.4303|TWO_SIDED|0.4303|0.5|5.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.07|0.50|0.4303
71141783|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|1.41||||0.5529|TWO_SIDED|95.0|0.45|4.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.39|0.45|0.5529
71141784|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|1.87||||0.3268|TWO_SIDED|95.0|0.53|6.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.55|0.53|0.3268
71141785|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|10.02||||0.0343|TWO_SIDED|95.0|1.19|84.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||84.66|1.19|0.0343
70950253|NCT00760747|141401596|SUPERIORITY_OR_OTHER||Least square mean differences at week 10|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.898|TWO_SIDED|95.0|-0.4|0.4|||Mixed Models Analysis|||||0.4|-0.4|0.898
71141786|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|9.45||||0.0391|TWO_SIDED|95.0|1.12|79.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||79.82|1.12|0.0391
70950254|NCT00760747|141401601|SUPERIORITY_OR_OTHER||Least square mean differences at week 2|-0.1|STANDARD_ERROR_OF_MEAN|1.4||0.927|TWO_SIDED|95.0|-2.9|2.6|||Mixed Models Analysis|||||2.6|-2.9|0.927
70950255|NCT03321253|141401612|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
70950256|NCT00455741|141401655|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||effect of age on estrogen negative feedback ( nadir LH as % of baseline LH)||||0.90
70950257|NCT00455741|141401655|SUPERIORITY||||||<|0.03||||||a priori threshold for significance is p\<0.05|ANOVA|||positive feedback||||<0.03
70950258|NCT00455741|141401656|SUPERIORITY||||||=|0.03||||||a priori significance level p\<0.05|ANOVA|||||||=0.03
70950259|NCT00455741|141401657|SUPERIORITY|||||||0.49||||||threshold for significance p\<0.05|t-test, 2 sided|||||||0.49
70867345|NCT01681472|141220749|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70950260|NCT00455741|141401658|SUPERIORITY||||||<|0.02||||||a priori threshold for significance p\<0.05|t-test, 2 sided|||||||<0.02
71141787|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|13.31||||0.0187|TWO_SIDED|95.0|1.54|115.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||115.1|1.54|0.0187
71141788|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|2.6||||0.1475|TWO_SIDED|95.0|0.71|9.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.47|0.71|0.1475
70867346|NCT01681472|141220749|SUPERIORITY|||||||0.0933|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0933
70867347|NCT01681472|141220749|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867348|NCT01681472|141220750|SUPERIORITY|||||||0.0177|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0177
70950261|NCT00455741|141401659|SUPERIORITY||||||<|0.03|||||||t-test, 2 sided|||||||<0.03
70950262|NCT00455741|141401660|SUPERIORITY|||||||0.07||||||a priori significance set at p\<0.05|t-test, 2 sided|||||||0.07
70950263|NCT00935532|141401705|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of exenatide QW to insulin glargine with respect to change in HbA1c was to be concluded if the upper limit of the 95% confidence interval (CI) for the treatment difference was less than 0.4%. Change in HbA1c from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, baseline HbA1c stratum (\<8.5%, \>=8.5%), background OAD, and presence/absence of pretreatment with SU as factors and baseline HbA1c as a covariate.|Least Squares Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.59|-0.26||No adjustments for multiplicity will be performed|ANCOVA|||The expected changes in HbA1c from baseline were considered to be the same between the groups, and the common standard deviation assumed to be 1.2%. Assuming a type I error of 0.025 (one-sided), a power of 0.9 and a noninferiority margin of 0.4%, 191 subjects per group would be necessary to confirm the noninferiority by the two-sample t-test. When the proportion of the subjects missing post-baseline data was assumed to be 10%, the target number of subjects were 420 in total (210 subjects/group).||-0.26|-0.59|<.001
70950264|NCT00935532|141401706|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Percentage of subjects achieving HbA1c\<=7% at endpoint were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which background OAD and presence/absence of pretreatment with SU served as the stratification factors.||||<.001
70950265|NCT00935532|141401707|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Percentage of subjects achieving HbA1c\<=6.5% at endpoint were compared between treatments using a CMH test, in which background OAD and presence/absence of pretreatment with SU served as the stratification factors.||||<.001
71141789|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|2.19||||0.2161|TWO_SIDED|95.0|0.63|7.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.55|0.63|0.2161
70950266|NCT00935532|141401708|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.28|STANDARD_ERROR_OF_MEAN|3.23||0.103|TWO_SIDED|95.0|-11.62|1.07|||ANCOVA|||Change in FSG from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline FSG as a covariate.||1.07|-11.62|0.103
71141790|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|1.79||||0.3478|TWO_SIDED|95.0|0.53|6.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.04|0.53|0.3478
70867349|NCT01681472|141220750|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71141791|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|2.22||||0.2269|TWO_SIDED|95.0|0.61|8.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.14|0.61|0.2269
71141792|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|4.66||||0.0683|TWO_SIDED|95.0|0.89|24.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||24.35|0.89|0.0683
71141793|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|7.11||||0.0228|TWO_SIDED|95.0|1.31|38.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||38.49|1.31|0.0228
71141794|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|3.95||||0.062|TWO_SIDED|95.0|0.93|16.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||16.72|0.93|0.0620
71141795|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|2.18||||0.2251|TWO_SIDED|95.0|0.62|7.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.67|0.62|0.2251
71141796|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|1.18||||0.7908|TWO_SIDED|95.0|0.35|3.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.99|0.35|0.7908
71141797|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|1.84||||0.3735|TWO_SIDED|95.0|0.48|7.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.06|0.48|0.3735
71141798|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|2.49||||0.1856|TWO_SIDED|95.0|0.64|9.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.64|0.64|0.1856
71141799|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|2.67||||0.01798|TWO_SIDED|95.0|0.64|11.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||11.20|0.64|0.01798
71141800|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|3.19||||0.1101|TWO_SIDED|95.0|0.77|13.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||13.22|0.77|0.1101
71141801|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|2.99||||0.106|TWO_SIDED|95.0|0.79|11.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||11.31|0.79|0.1060
71141802|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|1.47||||0.5258|TWO_SIDED|95.0|0.45|4.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.86|0.45|0.5258
71141803|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|1.1||||0.8746|TWO_SIDED|95.0|0.34|3.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.50|0.34|0.8746
71141804|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|0.82||||0.7434|TWO_SIDED|95.0|0.24|2.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.77|0.24|0.7434
71141805|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|1.9||||0.3211|TWO_SIDED|95.0|0.53|6.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||6.80|0.53|0.3211
71141806|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|1.51||||0.533|TWO_SIDED|95.0|0.41|5.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.48|0.41|0.5330
70867350|NCT01681472|141220750|SUPERIORITY|||||||0.0058|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0058
70867351|NCT01681472|141220750|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867352|NCT01681472|141220750|SUPERIORITY|||||||0.0043|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0043
70867353|NCT01681472|141220750|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867354|NCT01681472|141220751|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867355|NCT01681472|141220751|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867356|NCT01681472|141220751|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70950267|NCT00935532|141401709|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.01|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-2.46|-1.56|||ANCOVA|||Change in body weight from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline body weight as a covariate.||-1.56|-2.46|<.001
70950268|NCT00935532|141401710|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.89|STANDARD_ERROR_OF_MEAN|2.26|<|0.001|TWO_SIDED|95.0|-12.33|-3.45|||ANCOVA|||Change in total cholesterol from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline total cholesterol as a covariate.||-3.45|-12.33|<.001
71141807|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|3.0||||0.1119|TWO_SIDED|95.0|0.77|11.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||11.64|0.77|0.1119
71141808|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|1.76||||0.354|TWO_SIDED|95.0|0.53|5.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.85|0.53|0.3540
70867357|NCT01681472|141220751|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867358|NCT01681472|141220751|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867359|NCT01681472|141220751|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867360|NCT01681472|141220752|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867361|NCT01681472|141220752|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867362|NCT01681472|141220752|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867363|NCT01681472|141220752|SUPERIORITY|||||||0.0668|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0668
70867364|NCT01681472|141220752|SUPERIORITY|||||||0.0502|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0502
70867365|NCT01681472|141220752|SUPERIORITY|||||||0.0081|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0081
70867366|NCT01681472|141220753|SUPERIORITY|||||||0.0011|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0011
70950269|NCT00935532|141401711|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.69||0.689|TWO_SIDED|95.0|-1.64|1.09|||ANCOVA|||Change in HDL-C from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pre-treatment with SU as factors and baseline HDL-C as a covariate.||1.09|-1.64|0.689
70867367|NCT01681472|141220753|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867368|NCT01681472|141220753|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
70867369|NCT01681472|141220753|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867370|NCT01681472|141220753|SUPERIORITY|||||||0.6691|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.6691
70867371|NCT01681472|141220753|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867372|NCT01681472|141220754|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
70867373|NCT01681472|141220754|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867374|NCT01681472|141220754|SUPERIORITY|||||||0.064|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0640
70867375|NCT01681472|141220754|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867376|NCT01681472|141220754|SUPERIORITY|||||||0.1213|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1213
70867377|NCT01681472|141220754|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867378|NCT01681472|141220755|SUPERIORITY|||||||0.1791|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1791
70867379|NCT01681472|141220755|SUPERIORITY|||||||0.4945|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.4945
70867380|NCT01681472|141220755|SUPERIORITY|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0014
70867381|NCT01681472|141220755|SUPERIORITY|||||||0.599|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.5990
70867382|NCT01681472|141220755|SUPERIORITY|||||||0.0303|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0303
70867383|NCT01681472|141220755|SUPERIORITY|||||||0.0107|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0107
70950270|NCT00935532|141401712|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|1.0|STANDARD_ERROR_OF_MEAN|1.03||0.99|TWO_SIDED|95.0|0.94|1.06|||ANCOVA|||Triglycerides data were logarithm-transformed and the change at endpoint to baseline, expressed as the ratio, was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline triglycerides as a covariate.||1.06|0.94|0.990
71141809|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|0.65||||0.5076|TWO_SIDED|95.0|0.19|2.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.29|0.19|0.5076
71141810|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|0.71||||0.5801|TWO_SIDED|95.0|0.21|2.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.41|0.21|0.5801
70867384|NCT01681472|141220756|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867385|NCT01681472|141220756|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867386|NCT01681472|141220756|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
70867387|NCT01681472|141220756|SUPERIORITY|||||||0.0125|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0125
70867388|NCT01681472|141220756|SUPERIORITY|||||||0.0017|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0017
70867389|NCT01681472|141220756|SUPERIORITY|||||||0.5286|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.5286
70867390|NCT01681472|141220757|OTHER||Correlation factor|-0.21666||||0.6063|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in tumor||||0.6063
70867391|NCT01681472|141220757|OTHER||Correlation factor|0.54039||||0.2105|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in tumor||||0.2105
70867392|NCT01681472|141220757|OTHER||Correlation factor|0.27618||||0.5079|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.5079
70867393|NCT01681472|141220757|OTHER||Correlation factor|0.68223||||0.0913|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.0913
70867394|NCT01681472|141220758|OTHER||Correlation factor|0.38298||||0.3964|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in tumor||||0.3964
70867395|NCT01681472|141220758|OTHER||Correlation factor|0.27018||||0.5175|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in tumor||||0.5175
70867396|NCT01681472|141220758|OTHER||Correlation factor|-0.02188||||0.959|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in tumor||||0.9590
70867397|NCT01681472|141220758|OTHER||Correlation factor|0.45404||||0.3061|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.3061
70867398|NCT01681472|141220758|OTHER||Correlation factor|0.34905||||0.3967|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.3967
70867399|NCT01681472|141220758|OTHER||Correlation factor|0.07937||||0.8518|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.8518
70867400|NCT01681472|141220759|OTHER||Correlation factor|0.73743||||0.0586|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor||||0.0586
70867401|NCT01681472|141220759|OTHER||Correlation factor|0.44757||||0.2661|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor||||0.2661
70867402|NCT01681472|141220759|OTHER||Correlation factor|0.03292||||0.9506|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor||||0.9506
70867403|NCT01681472|141220759|OTHER||Correlation factor|0.09033||||0.8315|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor||||0.8315
70867404|NCT01681472|141220759|OTHER||Correlation factor|0.76502||||0.0451|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in adjacent mucosa||||0.0451
70867405|NCT01681472|141220759|OTHER||Correlation factor|0.34496||||0.4027|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.4027
70867406|NCT01681472|141220759|OTHER||Correlation factor|-0.66295||||0.1513|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.1513
70867407|NCT01681472|141220759|OTHER||Correlation factor|0.36854||||0.369|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.3690
70867408|NCT01681472|141220760|OTHER||Correlation factor|0.23512||||0.5751|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.5751
70867409|NCT01681472|141220760|OTHER||Correlation factor|0.02576||||0.9672|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.9672
70867410|NCT01681472|141220760|OTHER||Correlation factor|0.68778||||0.0594|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor||||0.0594
70867411|NCT01681472|141220760|OTHER||Correlation factor|0.11512||||0.8281|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor||||0.8281
70867412|NCT01681472|141220761|OTHER|||||||0.0451|||||||pearson|||||||0.0451
70867413|NCT01681472|141220762|OTHER||Correlation factor|0.42972||||0.3359|TWO_SIDED||||||Pearson Correlation|||Correlation for AMT gene expression||||0.3359
70867414|NCT01681472|141220762|OTHER||Correlation factor|0.75404||||0.0307|TWO_SIDED||||||Pearson Correlation|||Correlation for AMT gene expression||||0.0307
70867415|NCT01681472|141220762|OTHER||Correlation factor|-0.7073||||0.116|TWO_SIDED||||||Pearson Correlation|||Correlation for AMT gene expression||||0.1160
70867416|NCT01681472|141220762|OTHER||Correlation factor|-0.47193||||0.2377|TWO_SIDED||||||Pearson Correlation|||Correlation for AMT gene expression||||0.2377
70867417|NCT01681472|141220762|OTHER||Correlation factor|0.88128||||0.0087|TWO_SIDED||||||Pearson Correlation|||Correlation for PCFT gene expression||||0.0087
70867418|NCT01681472|141220762|OTHER||Correlation factor|0.58502||||0.1277|TWO_SIDED||||||Pearson Correlation|||Correlation for PCFT gene expression||||0.1277
70867419|NCT01681472|141220762|OTHER||Correlation factor|0.89976||||0.0146|TWO_SIDED||||||Pearson Correlation|||Correlation for PCFT gene expression||||0.0146
70867420|NCT01681472|141220762|OTHER||Correlation factor|0.11497||||0.7863|TWO_SIDED||||||Pearson Correlation|||Correlation for PCFT gene expression||||0.7863
70867421|NCT01681472|141220762|OTHER||Correlation factor|0.97624||||0.0002|TWO_SIDED||||||Pearson Correlation|||Correlation for FPGS gene expression||||0.0002
70867422|NCT01681472|141220762|OTHER||Correlation factor|0.88682||||0.0033|TWO_SIDED||||||Pearson Correlation|||Correlation for FPGS gene expression||||0.0033
70867423|NCT01681472|141220762|OTHER||Correlation factor|-0.64743||||0.1645|TWO_SIDED||||||Pearson Correlation|||Correlation for FPGS gene expression||||0.1645
70867424|NCT01681472|141220762|OTHER||Correlation factor|0.17664||||0.6756|TWO_SIDED||||||Pearson Correlation|||Correlation for FPGS gene expression||||0.6756
70867425|NCT01681472|141220762|OTHER||Correlation factor|0.94364||||0.0014|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFS gene expression||||0.0014
70867426|NCT01681472|141220762|OTHER||Correlation factor|0.43194||||0.2852|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFS gene expression||||0.2852
70867427|NCT01681472|141220762|OTHER||Correlation factor|0.58419||||0.2234|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFS gene expression||||0.2234
70867428|NCT01681472|141220762|OTHER||Correlation factor|0.9584||||0.0002|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFS gene expression||||0.0002
70867429|NCT01681472|141220762|OTHER||Correlation factor|-0.38987||||0.3873|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC3 gene expression||||0.3873
71141811|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|0.48||||0.2785|TWO_SIDED|95.0|0.13|1.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.82|0.13|0.2785
71141812|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|0.69||||0.5656|TWO_SIDED|95.0|0.19|2.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.45|0.19|0.5656
71141813|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|0.73||||0.6445|TWO_SIDED|95.0|0.19|2.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.81|0.19|0.6445
71141814|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|1.27||||0.7363|TWO_SIDED|95.0|0.32|4.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||4.99|0.32|0.7363
71141815|NCT03192176|141778538|SUPERIORITY||Odds Ratio (OR)|0.56||||0.3455|TWO_SIDED|95.0|0.17|1.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.86|0.17|0.3455
71141816|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|4.3||||0.0037|TWO_SIDED|95.0|1.6|11.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||11.54|1.60|0.0037
70867430|NCT01681472|141220762|OTHER||Correlation factor|-0.25891||||0.5358|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC3 gene expression||||0.5358
70867431|NCT01681472|141220762|OTHER||Correlation factor|0.777||||0.0691|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC3 gene expression||||0.0691
70867432|NCT01681472|141220762|OTHER||Correlation factor|0.00322||||0.994|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC3 gene expression||||0.9940
70867433|NCT01681472|141220762|OTHER||Correlation factor|0.93711||||0.0018|TWO_SIDED||||||Pearson Correlation|||Correlation for GGH gene expression||||0.0018
70867434|NCT01681472|141220762|OTHER||Correlation factor|0.46883||||0.2413|TWO_SIDED||||||Pearson Correlation|||Correlation for GGH gene expression||||0.2413
70867435|NCT01681472|141220762|OTHER||Correlation factor|-0.09737||||0.8544|TWO_SIDED||||||Pearson Correlation|||Correlation for GGH gene expression||||0.8544
70867436|NCT01681472|141220762|OTHER||Correlation factor|0.78928||||0.0199|TWO_SIDED||||||Pearson Correlation|||Correlation for GGH gene expression||||0.0199
70867437|NCT01681472|141220762|OTHER||Correlation factor|0.82963||||0.0209|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC1 gene expression||||0.0209
70867438|NCT01681472|141220762|OTHER||Correlation factor|-0.16724||||0.6922|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC1 gene expression||||0.6922
70867439|NCT01681472|141220762|OTHER||Correlation factor|0.14436||||0.785|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC1 gene expression||||0.7850
70867440|NCT01681472|141220762|OTHER||Correlation factor|0.74757||||0.033|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC1 gene expression||||0.0330
71141817|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|3.95||||0.0057|TWO_SIDED|95.0|1.49|10.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||10.48|1.49|0.0057
71141818|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|6.03||||0.0003|TWO_SIDED|95.0|2.26|16.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.13|2.26|0.0003
70867441|NCT01681472|141220762|OTHER||Correlation factor|0.32113||||0.4825|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFD1L gene expression||||0.4825
70867442|NCT01681472|141220762|OTHER||Correlation factor|0.3716||||0.3647|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFD1L gene expression||||0.3647
70867443|NCT01681472|141220762|OTHER||Correlation factor|0.20955||||0.6903|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFD1L gene expression||||0.6903
70867444|NCT01681472|141220762|OTHER||Correlation factor|0.74459||||0.0341|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFD1L gene expression||||0.0341
70867445|NCT01681472|141220762|OTHER||Correlation factor|0.50966||||0.2426|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT1 gene expression||||0.2426
70867446|NCT01681472|141220762|OTHER||Correlation factor|0.67853||||0.0643|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT1 gene expression||||0.0643
70867447|NCT01681472|141220762|OTHER||Correlation factor|0.05531||||0.9171|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT1 gene expression||||0.9171
70950271|NCT04954326|141401730|EQUIVALENCE|The 90% Confidence Interval of the geometric mean ratios of the Lyophilisate compared to the Liquid formulations for AUCinf should be completely contained within the predefined \[80.00%-125.00%\] equivalence interval.|Geometric Mean Ratio (%)|102.8||||0.05|TWO_SIDED|90.0|91.4|115.6|||ANOVA|||AUCinf was natural log-transformed and analyzed using an analysis of variance (ANOVA) with fixed effect for formulation. The two one-sided tests procedures were performed on the geometric mean ratio (GMR) between test (S95014 lyophilizate) and reference (S95014 liquid formulation) treatments. The 90% confidence interval for the ratio was obtained within the framework of the ANOVA.||115.6|91.4|0.05
70950272|NCT04954326|141401731|EQUIVALENCE|The 90% Confidence Interval of the geometric mean ratios of the Lyophilisate compared to the Liquid formulations for Cmax should be completely contained within the predefined \[80.00%-125.00%\] equivalence interval.|Geometric Mean Ratio (%)|93.5||||0.05|TWO_SIDED|90.0|82.9|105.5|||ANOVA|||Cmax was natural log-transformed and analyzed using an analysis of variance (ANOVA) with fixed effect for formulation. The two one-sided tests procedures were performed on the geometric mean ratio (GMR) between test (S95014 lyophilizate) and reference (S95014 liquid formulation) treatments. The 90% confidence interval for the ratio was obtained within the framework of the ANOVA.||105.5|82.9|0.05
70950273|NCT04954326|141401732|EQUIVALENCE|The 90% Confidence Interval of the geometric mean ratios of the Lyophilisate compared to the Liquid formulations for Cday14 should be completely contained within the predefined \[80.00%-125.00%\] equivalence interval.|Geometric Mean Ratio (%)|121.5||||0.05|TWO_SIDED|90.0|98.7|149.6|||ANOVA|||Cday14 was natural log-transformed and analyzed using an analysis of variance (ANOVA) with fixed effect for formulation. The two one-sided tests procedures were performed on the geometric mean ratio (GMR) between test (S95014 lyophilizate) and reference (S95014 liquid formulation) treatments. The 90% confidence interval for the ratio was obtained within the framework of the ANOVA.||149.6|98.7|0.05
70950274|NCT04982575|141401735|OTHER||Treatment difference|-0.3||||0.2284|TWO_SIDED|95.0|-0.79|0.19|||Mixed Models Analysis|||The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor as factors and baseline HbA1c as a covariate using retrieved participants multiple imputation of missing data regardless of treatment or stratification.||0.19|-0.79|0.2284
70950275|NCT00475228|141401745|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|||||||0.05
70867448|NCT01681472|141220762|OTHER||Correlation factor|0.59183||||0.1222|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT1 gene expression||||0.1222
70867449|NCT01681472|141220762|OTHER||Correlation factor|0.8104||||0.0271|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT2 gene expression||||0.0271
70867450|NCT01681472|141220762|OTHER||Correlation factor|0.86266||||0.0058|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT2 gene expression||||0.0058
70867451|NCT01681472|141220762|OTHER||Correlation factor|-0.71666||||0.109|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT2 gene expression||||0.1090
70867452|NCT01681472|141220762|OTHER||Correlation factor|0.55508||||0.1533|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT2 gene expression||||0.1533
70950276|NCT03931746|141401749|SUPERIORITY||Hodges-Lehmann median difference|-3.5||||0.04|TWO_SIDED|95.0|-8.0|-0.5|||Wilcoxon (Mann-Whitney)|An exact Wilcoxon two-sample test was performed owing to the small sample size and number of tied observations.|Median difference is for Porcine Xenograft group minus No Porcine Xenograft group.|||-0.5|-8.0|0.04
70950277|NCT03931746|141401750|SUPERIORITY||Hodges-Lehmann median difference|-2.5||||0.75|TWO_SIDED|95.0|-9.0|12.0|||Wilcoxon (Mann-Whitney)|An exact Wilcoxon two-sample test was performed owing to the small sample size and number of tied observations.|Median difference is for Porcine Xenograft minus No Porcine Xenograft.|||12|-9|0.75
70950278|NCT03931746|141401751|SUPERIORITY||Hodges-Lehmann median difference|1.0||||1|TWO_SIDED|95.0|-19.0|20.0|||Wilcoxon (Mann-Whitney)|An exact Wilcoxon two-sample test was performed owing to the small sample size and number of tied observations.|Median difference is for Porcine Xenograft group minus No Porcine Xenograft group.|||20.0|-19.0|1
70950279|NCT03931746|141401752|SUPERIORITY||Hodges-Lehmann median difference|0.01||||1|TWO_SIDED|95.0|-0.26|0.33|||Wilcoxon (Mann-Whitney)|An exact Wilcoxon two-sample test was performed owing to the small sample size and number of tied observations.|Median difference is for Porcine Xenograft vs. No Porcine Xenograft.|||0.33|-0.26|1
71141819|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|6.42||||0.0003|TWO_SIDED|95.0|2.37|17.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||17.39|2.37|0.0003
71141820|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.11||||0.141|TWO_SIDED|95.0|0.78|5.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||5.73|0.78|0.1410
71141821|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|5.85||||0.0004|TWO_SIDED|95.0|2.2|15.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||15.55|2.20|0.0004
71141822|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|5.5||||0.0006|TWO_SIDED|95.0|2.08|14.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||14.54|2.08|0.0006
71141823|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|4.09||||0.0037|TWO_SIDED|95.0|1.58|10.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.57|1.58|0.0037
71141824|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|4.31||||0.0026|TWO_SIDED|95.0|1.67|11.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||11.16|1.67|0.0026
70867453|NCT01681472|141220762|OTHER||Correlation factor|0.318||||0.487|TWO_SIDED||||||Pearson Correlation|||Correlation for RFC-1 gene expression||||0.4870
70867454|NCT01681472|141220762|OTHER||Correlation factor|0.23312||||0.5785|TWO_SIDED||||||Pearson Correlation|||Correlation for RFC-1 gene expression||||0.5785
70867455|NCT01681472|141220762|OTHER||Correlation factor|-0.0245||||0.9632|TWO_SIDED||||||Pearson Correlation|||Correlation for RFC-1 gene expression||||0.9632
70867456|NCT01681472|141220762|OTHER||Correlation factor|0.64565||||0.0838|TWO_SIDED||||||Pearson Correlation|||Correlation for RFC-1 gene expression||||0.0838
70867457|NCT00667875|141220768|SUPERIORITY|||||||0.49||||||The p value represents variation of the total 16 week trial over all three groups.|Mixed Models Analysis|||Analyzed as a mixed model, Group by time (4 time blocks) with an unstructured variance/covariance matrix. Baseline drinks per day was used as a covariate.||||0.49
70867458|NCT00667875|141220769|SUPERIORITY|||||||0.03||||||The p value represents variation of the total 16 week trial over all three groups.|Mixed Models Analysis|||Analyzed as a mixed model (SPSS linear mixed) with an unstructured variance/covariance and baseline percent heavy drinking days as a covariate||||0.03
70867459|NCT00667875|141220770|SUPERIORITY|Anova across all three treatment groups|||||<|0.05|||||||ANOVA|Naltrexone or naltrexone placebo pills taken F=3.9 df 2 Aripiprazole or aripiprazole placebo pills taken F=4.6 df 2||||||<.05
70867460|NCT00667875|141220771|SUPERIORITY||||||<|0.05|||||||ANOVA|f 3.2 df 2||Anova across three groups||||<.05
70867461|NCT00795145|141220778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.47||||||90.0|-0.7|3.64||||||Inferential analysis at 0.5 hour post-dose||3.64|-0.7|
70950280|NCT03931746|141401753|SUPERIORITY||Hodges-Lehmann median difference|0.0||||1|TWO_SIDED|95.0|-6.0|4.0|||Wilcoxon (Mann-Whitney)|An exact Wilcoxon two-sample test was performed owing to the small sample size and number of tied observations.|Median difference is for Porcine Xenograft group minus No Porcine Xenograft group.|||4|-6|1
70950281|NCT03931746|141401754|SUPERIORITY||Hodges-Lehmann median difference|0.5||||0.54|TWO_SIDED|95.0|-1.0|2.0|||Wilcoxon (Mann-Whitney)|An exact Wilcoxon two-sample test was performed owing to the small sample size and number of tied observations.|Median difference is for Porcine Xenograft group minus No Porcine Xenograft group.|||2|-1|0.54
70867462|NCT00795145|141220778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.96||||||90.0|-5.13|-0.79||||||Inferential analysis at 1 hour post-dose||-0.79|-5.13|
70867463|NCT00795145|141220778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.53||||||90.0|-7.7|-3.36||||||Inferential analysis at 2 hour post-dose||-3.36|-7.70|
70867464|NCT00795145|141220778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||||90.0|-1.77|2.57||||||Inferential analysis at 4 hour post-dose||2.57|-1.77|
70867465|NCT00795145|141220778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.37||||||90.0|-3.54|0.8||||||Inferential analysis at 8 hour post-dose||0.80|-3.54|
70867466|NCT00795145|141220778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01||||||90.0|-1.16|3.18||||||Inferential analysis at 12 hour post-dose||3.18|-1.16|
70867467|NCT00795145|141220778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||||90.0|-2.81|1.53||||||Inferential analysis at 24 hour post-dose||1.53|-2.81|
70867468|NCT00795145|141220778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.49||||||90.0|0.32|4.66||||||Inferential analysis at 0.5 hour post-dose||4.66|0.32|
70867469|NCT00795145|141220778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.78||||||90.0|-3.95|0.39||||||Inferential analysis at 1 hour post-dose||0.39|-3.95|
70867470|NCT00795145|141220778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.51||||||90.0|-9.68|-5.34||||||Inferential analysis at 2 hour post-dose||-5.34|-9.68|
70867471|NCT00795145|141220778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.47||||||90.0|1.3|5.64||||||Inferential analysis at 4 hour post-dose||5.64|1.30|
70867472|NCT00795145|141220778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.13||||||90.0|-1.04|3.3||||||Inferential analysis at 8 hour post-dose||3.30|-1.04|
70867473|NCT00795145|141220778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.47||||||90.0|-0.7|3.64||||||Inferential analysis at 12 hour post-dose||3.64|-0.70|
70950282|NCT03931746|141401755|SUPERIORITY||Odds Ratio (OR)|0.69||||1|TWO_SIDED|95.0|0.03|13.3|||Fisher Exact||"The No Porcine Xenograft group is the reference group."|||13.3|0.03|1
70950283|NCT03931746|141401756|SUPERIORITY||Risk Difference (RD)|-0.167||||0.43|TWO_SIDED|95.0|-0.564|0.185|||Fisher Exact||"The risk difference is calculated as the outcome risk in the Porcine Xenograft group minus the outcome risk in the No Porcine Xenograft group. The confidence interval for the risk difference was calculated using the Newcombe hybrid score method."|||0.185|-0.564|0.43
70867474|NCT00795145|141220778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||||90.0|-0.37|3.97||||||Inferential analysis at 24 hour post-dose||3.97|-0.37|
70867475|NCT00795145|141220779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.27||||||90.0|1.1|5.44||||||Inferential analysis at 0.5 hour post-dose||5.44|1.10|
70867476|NCT00795145|141220779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.83||||||90.0|4.66|9.0||||||Inferential analysis at 1 hour post-dose||9.00|4.66|
70867477|NCT00795145|141220779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.27||||||90.0|8.1|12.44||||||Inferential analysis at 2 hour post-dose||12.44|8.10|
70867478|NCT00795145|141220779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.84||||||90.0|7.67|12.01||||||Inferential analysis at 4 hour post-dose||12.01|7.67|
70867479|NCT00795145|141220779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.4||||||90.0|7.23|11.58||||||Inferential analysis at 8 hour post-dose||11.58|7.23|
70867480|NCT00795145|141220779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.05||||||90.0|4.87|9.22||||||Inferential analysis at 12 hour post-dose||9.22|4.87|
70867481|NCT00795145|141220779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.52||||||90.0|4.35|8.69||||||Inferential analysis at 24 hour post-dose||8.69|4.35|
70867482|NCT00795145|141220780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.49||||||90.0|-5.54|2.57||||||Inferential analysis at 0.5 hour post-dose||2.57|-5.54|
70867483|NCT00795145|141220780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.45||||||90.0|-11.51|-3.4||||||Inferential analysis at 1 hour post-dose||-3.40|-11.51|
70867484|NCT00795145|141220780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.75||||||90.0|-9.81|-1.7||||||Inferential analysis at 2 hour post-dose||-1.70|-9.81|
70867485|NCT00795145|141220780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||||90.0|-4.97|3.13||||||Inferential analysis at 4 hour post-dose||3.13|-4.97|
70950284|NCT03931746|141401757|SUPERIORITY||Odds Ratio (OR)|0.6||||1|TWO_SIDED|95.0|0.006|55.9|||Fisher Exact||"The No Porcine Xenograft group is the reference group."|||55.9|0.006|1
70950285|NCT02473965|141401764|SUPERIORITY||Odds Ratio (OR)|0.868|||=|1|TWO_SIDED|95.0|0.27|2.787||The statistical inference was tested as 2-sided with alpha=0.05.|Fisher Exact|||An unstratified analysis using Fisher's exact test was used for treatment comparison without adjustment for stratified baseline prednisone equivalent dose level due to the small cell size. The odds ratio and confidence intervals are calculated overall (i.e. all mITT subjects).||2.787|0.270|=1.00
70950286|NCT02473965|141401765|SUPERIORITY||LS mean difference|1.58|STANDARD_ERROR_OF_MEAN|12.536|=|0.9|TWO_SIDED|95.0|-23.52|26.68|||ANCOVA|||Treatment comparison of percent change in daily CS dose from baseline to Week 39. The Analysis of Covariance model included the percent change from baseline in daily CS dose as the dependent variable, treatment as a fixed effect and baseline daily CS dose as covariate.||26.68|-23.52|=0.900
70950287|NCT01183390|141401767|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.6|||||TWO_SIDED|90.0|95.1|102.28|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||102.28|95.10|
70950288|NCT01183390|141401768|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.4|||||TWO_SIDED|90.0|96.99|101.8|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.80|96.99|
71141825|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|6.26||||0.0002|TWO_SIDED|95.0|2.63|16.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||16.60|2.63|0.0002
70867486|NCT00795145|141220780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.64||||||90.0|-9.69|-1.58||||||Inferential analysis at 8 hour post-dose||-1.58|-9.69|
70867487|NCT00795145|141220780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.29||||||90.0|-6.34|1.77||||||Inferential analysis at 12 hour post-dose||1.77|-6.34|
70867488|NCT00795145|141220780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59||||||90.0|-4.64|3.47||||||Inferential analysis at 24 hour post-dose||3.47|-4.64|
70867489|NCT00795145|141220780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.49||||||90.0|-7.54|0.57||||||Inferential analysis at 0.5 hour post-dose||0.57|-7.54|
70867490|NCT00795145|141220780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.19||||||90.0|-16.24|-8.13||||||Inferential analysis at 1 hour post-dose||-8.13|-16.24|
70867491|NCT00795145|141220780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.39||||||90.0|-18.44|-10.33||||||Inferential analysis at 2 hour post-dose||-10.33|-18.44|
70867492|NCT00795145|141220780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.19||||||90.0|-6.24|1.87||||||Inferential analysis at 4 hour post-dose||1.87|-6.24|
70867493|NCT00795145|141220780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||||90.0|-2.95|5.15||||||Inferential analysis at 8 hour post-dose||5.15|-2.95|
70867494|NCT00795145|141220780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||||90.0|-3.94|4.17||||||Inferential analysis at 12 hour post-dose||4.17|-3.94|
70867495|NCT00795145|141220780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.68||||||90.0|-1.37|6.73||||||Inferential analysis at 24 hour post-dose||6.73|-1.37|
70950289|NCT01730950|141401794|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.46|TWO_SIDED|95.0|0.7|1.38|||Log Rank|Two-side significance level = 0.05|Reference level = Bevacizumab|Null hypothesis: median survival time for both arms is 9 months; alternative hypothesis: participants receiving radiation therapy plus bevacizumab will have an improvement in median survival time to 13 months. One hundred and sixty eligible participants provides 80% power to detect a 31% reduction in the hazard ratio to 0.69 at a one-sided significance level of 0.10. Analysis was planned to occur when 135 deaths were reported, expected to occur 16 to 21 months after trial closure.||1.38|0.70|0.46
70950290|NCT01730950|141401795|SUPERIORITY|||||||0.18|||||||Chi-squared|Two-sided significance level = 0.05||||||0.18
70950291|NCT01730950|141401796|SUPERIORITY|||||||0.001|||||||Chi-squared|Two-sided significance level = 0.05||||||0.001
70950292|NCT01730950|141401797|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.05|TWO_SIDED|95.0|0.53|1.0|||Log Rank|Two-sided significance level = 0.05|Reference level = Bevacizumab|||1.00|0.53|0.05
71141826|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|9.4|||<|0.0001|TWO_SIDED|95.0|3.23|27.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||27.34|3.23|<0.0001
70867496|NCT00144391|141220818|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
70867497|NCT06956170|141220856|OTHER||Hazard Ratio (HR)|0.53|||||TWO_SIDED|95.0|0.1|2.78|||||Hazard ratio was estimated using an unstratified Cox Proportional Hazard model with treatment arm as an explanatory variable.|||2.78|0.10|
70867498|NCT02280304|141220896|SUPERIORITY||||||>|0.05||||||A priori threshold = voxel p\<.001, cluster p\<.05, FDR whole brain correction. There is no correction for multiple seeds given small sample sizes and pre-post design. To report NS p-values and associated z-scores, uncorrected cluster ps were queried.|t-test, 1 sided|||Z-scores represent Fisher transformed correlation coefficients representing the correlations between hypothesized regions. Positive values represents positive connectivity between regions. Negative values represent anticorrelations, or negative relations, between hypothesized regions.||||>0.05
70867499|NCT02280304|141220897|OTHER||Mean Difference (Net)|1.8|||||TWO_SIDED|||||||||||||
70867500|NCT02280304|141220897|OTHER||Cohen's d|0.35|||||TWO_SIDED||||||||Cohen's d reflects Extent of Participation subscale of the CRIS, Post - Pre|||||
70867501|NCT02280304|141220897|OTHER||Median Difference (Net)|0.8|||||TWO_SIDED|||||||||||||
70867502|NCT02280304|141220897|OTHER||Cohen's d|0.14|||||TWO_SIDED||||||||Cohen's d reflects Extent of Participation Scale of the Cris pre- post|||||
70867503|NCT02280304|141220897|OTHER||Median Difference (Net)|0.8|||||TWO_SIDED|||||||||||||
70867504|NCT02280304|141220897|OTHER||Cohen's d|0.2|||||TWO_SIDED||||||||Cohens d reflects the Cris pre post Perceived Limitations scale|||||
70867505|NCT02280304|141220897|OTHER||Mean Difference (Net)|1.8|||||TWO_SIDED|||||||||||||
70867506|NCT02280304|141220897|OTHER||Cohens d|0.53|||||TWO_SIDED|||||||||||||
70867507|NCT02280304|141220897|OTHER||Mean Difference (Net)|1.3|||||TWO_SIDED|||||||||||||
70867508|NCT02280304|141220897|OTHER||Cohens d|0.29|||||TWO_SIDED|||||||||||||
71141827|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0431|TWO_SIDED|95.0|1.03|6.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.76|1.03|0.0431
70867509|NCT02280304|141220897|OTHER||Mean Difference (Net)|0.6|||||TWO_SIDED|||||||||||||
70867510|NCT02280304|141220897|OTHER||Cohens d|0.13|||||TWO_SIDED|||||||||||||
70867511|NCT02280304|141220898|OTHER||Cohens d|0.86|||||TWO_SIDED||||||||Cohen's d effect size (Cohen's d=.20 small, Cohen's d=.50 medium, Cohen's d=.80 large)|Cohen's d effect sizes are reported for changes over time (0 weeks vs. 12 weeks) in each group separately.||||
70867512|NCT02280304|141220898|OTHER||Cohens d|0.3|||||TWO_SIDED||||||||Cohen's d effect size (Cohen's d=.20 small, Cohen's d=.50 medium, Cohen's d=.80 large)|Cohen's d effect sizes are reported for changes over time (0 weeks vs. 12 weeks) in each group separately.||||
70867513|NCT02280304|141220899|OTHER||Cohens d|1.32|||||TWO_SIDED||||||||Cohen's d effect size change (Cohen's d =0.20 is a small effect; Cohen's d=0.50 is a medium effect; Cohen's d=0.80 is a large effect.)|Cohen's d effect sizes are reported for changes over time (0 weeks vs. 12 weeks) in each group separately.||||
70867514|NCT02280304|141220899|OTHER||Cohens d|0.27|||||TWO_SIDED||||||||Cohen's d effect size (Cohen's d =0.20 is a small effect; Cohen's d=0.50 is a medium effect; Cohen's d=0.80 is a large effect.)|Cohen's d effect sizes are reported for changes over time (0 weeks vs. 12 weeks) in each group separately.||||
70867515|NCT02280304|141220900|SUPERIORITY||||||<|0.0099||||||The p-value obtained for the L PHG seed/L IPL cluster is 0.0099. The critical p-value after Bonferroni correction for multiple seeds is p=.008.|t-test, 2 sided|Significance is determined when clusters reach voxel threshold p\<.001, cluster p\<.05 FDR corrected for multiple comparisons across the whole brain.||||||<.0099
70867516|NCT02280304|141220900|SUPERIORITY||||||<|0.02||||||The p-value obtained for the L anterior PGH seed/left VMPC cluster is 0.02. The critical p-value after Bonferroni correction for six seeds is p=.008.|t-test, 2 sided|Significance is determined when clusters reach voxel threshold p\<.001, cluster p\<.05 FDR corrected for multiple comparisons across the whole brain.||||||<0.02
70867517|NCT02280304|141220901|OTHER||Slope|0.02|||<|3.8e-05|TWO_SIDED|||||Cluster in MPFC p\<0.000038 FDR corrected for multiple comparisons across whole brain. Bonferroni correction for multiple seeds p=0.008.|Regression, Linear|Significance is determined when voxel (height) threshold p=.001, cluster threshold p=.05, FDR corrected for multiple tests across the whole brain.||The extent of community participation prior to therapy was correlated with the functional connectivity of the right hippocampus seed after therapy (post-pre).||||<.000038
70867518|NCT02280304|141220901|OTHER||Slope|0.02|||<|0.000149|TWO_SIDED|||||Cluster in the right cerebellum (crus 2) p\<0.000149 FDR corrected for multiple comparisons across the whole brain. Bonferroni for multiple seeds p=0.008.|Regression, Linear|Significance is determined when voxel (height) threshold p=.001, cluster threshold p=.05, FDR corrected for multiple tests across the whole brain.||The extent of community participation prior to therapy was correlated with the functional connectivity of the right hippocampus seed after therapy (post-pre).||||<0.000149
70867519|NCT03166735|141220922|OTHER||Predicted mean daily dose in mg|3.45|STANDARD_ERROR_OF_MEAN|0.1|||||||||non-linear regression||The model fit used power of mean variance estimates (POM) to account for heterogeneity.|D10: Estimated dose reaching \<=10% activity the first time.||||
70867520|NCT03166735|141220924|OTHER|The MMRM included fixed effects for 'base', 'treatment', 'time', 'base\*time' interaction, and 'treatment\*time' interaction. Estimates were used to test dose-response relationship using MCPMod.||||||0.0212||||||p\<0.05 is a significant test result (rejecting the null hypothesis of a flat dose-response curve) with alpha 0.05, one-sided.|MCPMod Sigmoidal Emax model fit.|30% of the maximum effect is achieved at 3 mg and 90% of the maximum effect is achieved at 7 mg of BI 1467335||||||0.0212
70867521|NCT03166735|141220925|OTHER|The MMRM included fixed effects for 'base', 'treatment', 'time', 'base\*time' interaction, and 'treatment\*time' interaction. Estimates were used to test dose-response relationship using MCPMod.||||||0.127||||||p\<0.05 is a significant test result (rejecting the null hypothesis of a flat dose-response curve) with alpha 0.05, one-sided.|MCPMod Sigmoidal Emax model fit.|30% of the maximum effect is achieved at 3 mg and 90% of the maximum effect is achieved at 7 mg of BI 1467335||||||0.1270
70867522|NCT03166735|141220926|OTHER|The MMRM included fixed effects for 'base', 'treatment', 'time', 'base\*time' interaction, and 'treatment\*time' interaction. Estimates were used to test dose-response relationship using MCPMod.||||||0.3324||||||p\<0.05 is a significant test result (rejecting the null hypothesis of a flat dose-response curve) with alpha 0.05, one-sided.|MCPMod exponential model fit.|90% of the maximum effect is achieved at 7 mg of BI 1467335||||||0.3324
70867523|NCT03166735|141220927|OTHER|The MMRM included fixed effects for 'base', 'treatment', 'time', 'base\*time' interaction, and 'treatment\*time' interaction. Estimates were used to test dose-response relationship using MCPMod.||||||0.129||||||p\<0.05 is a significant test result (rejecting the null hypothesis of a flat dose-response curve) with alpha 0.05, one-sided.|MCPMod exponential model fit.|90% of the maximum effect is achieved at 7 mg of BI 1467335||||||0.1290
70867524|NCT03166735|141220928|OTHER|The MMRM included fixed effects for 'base', 'treatment', 'time', 'base\*time' interaction, and 'treatment\*time' interaction. Estimates were used to test dose-response relationship using MCPMod.||||||0.0042||||||p\<0.05 is a significant test result (rejecting the null hypothesis of a flat dose-response curve) with alpha 0.05, one-sided.|MCPMod Sigmoidal Emax model fit.|30% of the maximum effect is achieved at 3 mg and 90% of the maximum effect is achieved at 7 mg of BI 1467335||||||0.0042
71141828|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|4.4||||0.002|TWO_SIDED|95.0|1.72|11.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||11.29|1.72|0.0020
71141829|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.76||||0.0291|TWO_SIDED|95.0|1.11|6.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.86|1.11|0.0291
71141830|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|3.96||||0.0063|TWO_SIDED|95.0|1.48|10.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.61|1.48|0.0063
71141831|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|3.11||||0.0202|TWO_SIDED|95.0|1.19|8.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.11|1.19|0.0202
71141832|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|4.1||||0.0044|TWO_SIDED|95.0|1.55|10.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.84|1.55|0.0044
71141833|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|9.21||||0.0002|TWO_SIDED|95.0|2.89|29.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||29.38|2.89|0.0002
71141834|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0706|TWO_SIDED|95.0|0.93|6.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.37|0.93|0.0706
71141835|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|8.2||||0.0001|TWO_SIDED|95.0|2.79|24.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||24.08|2.79|0.0001
71141836|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|3.24||||0.0146|TWO_SIDED|95.0|1.26|8.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.32|1.26|0.0146
71141837|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.37||||0.0816|TWO_SIDED|95.0|0.9|6.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.24|0.90|0.0816
71141838|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.25||||0.093|TWO_SIDED|95.0|0.87|5.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.81|0.87|0.0930
71141839|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.81||||0.365|TWO_SIDED|95.0|1.07|7.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.39|1.07|0.365
71141840|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|4.93||||0.0042|TWO_SIDED|95.0|1.65|14.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||14.73|1.65|0.0042
71141841|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.73||||0.0488|TWO_SIDED|95.0|1.01|7.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.41|1.01|0.0488
71141842|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|3.85||||0.0075|TWO_SIDED|95.0|1.43|10.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.36|1.43|0.0075
71141843|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.2||||0.0984|TWO_SIDED|95.0|0.86|5.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.59|0.86|0.0984
71141844|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|1.89||||0.2226|TWO_SIDED|95.0|0.68|5.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.29|0.68|0.2226
71141845|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.16||||0.1467|TWO_SIDED|95.0|0.76|6.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.08|0.76|0.1467
71141846|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.74||||0.0705|TWO_SIDED|95.0|0.92|8.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.19|0.92|0.0705
71141847|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|26.62||||0.0025|TWO_SIDED|95.0|3.16|223.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||223.9|3.16|0.0025
71141848|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.75||||0.0757|TWO_SIDED|95.0|0.9|8.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.40|0.90|0.0757
71141849|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|5.66||||0.0045|TWO_SIDED|95.0|1.71|18.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||18.74|1.71|0.0045
71141850|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.63||||0.0771|TWO_SIDED|95.0|0.9|7.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.67|0.90|0.0771
71141851|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.03||||0.1856|TWO_SIDED|95.0|0.71|5.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.81|0.71|0.1856
70950293|NCT00667459|141401800|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority margin is 0.1.|Risk Difference (RD)|0.032||||0.995|TWO_SIDED|95.0|-0.07|0.134||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P(p1 - p0 \> -d \| data) be at least 0.95, then the null noninferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.134|-0.070|0.995
70950294|NCT00667459|141401800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.736||95.0||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated. If the posterior probability is at least 0.95, a claim of superiority can be made.||||0.736
70950295|NCT00667459|141401801|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.048||||1|TWO_SIDED|95.0|-0.02|0.118||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the success rates of NDI in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P(p1 - p0 \> -d \| data) be at least 0.95, then the null noninferiority hypothesis will be rejected, and non-inferiority of the investigational group will be claimed for this endpoint."||0.118|-0.020|1.0
70950296|NCT00667459|141401801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.912||95.0||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||0.912
70950297|NCT00667459|141401802|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.099||||1|TWO_SIDED|95.0|0.038|0.161||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.161|0.038|1.0
70950298|NCT00667459|141401802|SUPERIORITY_OR_OTHER_LEGACY|||||||0.999||95.0||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||0.999
70950299|NCT00667459|141401803|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.034||||0.992|TWO_SIDED|95.0|-0.085|0.021||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.021|-0.085|0.992
71141852|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|1.31||||0.5973|TWO_SIDED|95.0|0.48|3.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.54|0.48|0.5973
71141853|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.57||||0.0935|TWO_SIDED|95.0|0.85|7.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.77|0.85|0.0935
71141854|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|5.52||||0.0157|TWO_SIDED|95.0|1.38|22.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||22.10|1.38|0.0157
71141855|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1963|TWO_SIDED|95.0|0.68|6.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.32|0.68|0.1963
70867525|NCT03166735|141220929|OTHER|The MMRM included fixed effects for 'base', 'treatment', 'time', 'base\*time' interaction, and 'treatment\*time' interaction. Estimates were used to test dose-response relationship using MCPMod.||||||0.0728||||||p\<0.05 is a significant test result (rejecting the null hypothesis of a flat dose-response curve) with alpha 0.05, one-sided.|MCPMod exponential model fit.|90% of the maximum effect is achieved at 7 mg of BI 1467335||||||0.0728
70867526|NCT01292746|141220932|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|2 sided t-test for correlated samples.||||||<0.05
71141856|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|5.31||||0.0085|TWO_SIDED|95.0|1.53|18.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||18.43|1.53|0.0085
71141857|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.21||||0.1433|TWO_SIDED|95.0|0.76|6.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.38|0.76|0.1433
71141858|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.17||||0.1577|TWO_SIDED|95.0|0.74|6.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.37|0.74|0.1577
71141859|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.16||||0.1608|TWO_SIDED|95.0|0.74|6.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.34|0.74|0.1608
71141860|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.96||||0.0693|TWO_SIDED|95.0|0.92|9.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.53|0.92|0.0693
71141861|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|9.57||||0.0063|TWO_SIDED|95.0|1.89|48.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||48.39|1.89|0.0063
71141862|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.25||||0.1637|TWO_SIDED|95.0|0.72|7.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.05|0.72|0.1637
71141863|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|3.57||||0.0326|TWO_SIDED|95.0|1.11|11.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||11.47|1.11|0.0326
71141864|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.24||||0.1455|TWO_SIDED|95.0|0.76|6.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.67|0.76|0.1455
71141865|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1951|TWO_SIDED|95.0|0.69|6.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.32|0.69|0.1951
71141866|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|1.56||||0.4097|TWO_SIDED|95.0|0.54|4.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.53|0.54|0.4097
71141867|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.29||||0.1554|TWO_SIDED|95.0|0.73|7.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.22|0.73|0.1554
71141868|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|4.22||||0.044|TWO_SIDED|95.0|1.04|17.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||17.14|1.04|0.0440
71141869|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.23||||0.1928|TWO_SIDED|95.0|0.67|7.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.47|0.67|0.1928
71141870|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|4.67||||0.0222|TWO_SIDED|95.0|1.25|17.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||17.47|1.25|0.0222
71141871|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|1.58||||0.4075|TWO_SIDED|95.0|0.54|4.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.65|0.54|0.4075
71141872|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|1.65||||0.3659|TWO_SIDED|95.0|0.56|4.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.93|0.56|0.3659
71141873|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|1.15||||0.7878|TWO_SIDED|95.0|0.41|3.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.24|0.41|0.7878
70950300|NCT00667459|141401803|SUPERIORITY_OR_OTHER_LEGACY|||||||0.097||||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||0.097
70950301|NCT00667459|141401804|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.01||||1|TWO_SIDED|95.0|-0.043|0.023||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.023|-0.043|1.0
70950302|NCT00667459|141401804|SUPERIORITY_OR_OTHER_LEGACY|||||||0.273||95.0||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||0.273
70872210|NCT01727297|141229672|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.53|TWO_SIDED|95.0|0.54|1.38||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having a prior stroke (more than one year pre-device implant) on a patient's risk of developing AF.|The null hypothesis was that prior stroke more than one year pre-device implant did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.38|0.54|0.53
71141874|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|3.26||||0.0635|TWO_SIDED|95.0|0.94|11.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||11.38|0.94|0.0635
71141875|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|14.62||||0.0137|TWO_SIDED|95.0|1.73|123.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||123.3|1.73|0.0137
71141876|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.91||||0.1069|TWO_SIDED|95.0|0.79|10.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||10.62|0.79|0.1069
71141877|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|5.6||||0.0186|TWO_SIDED|95.0|1.33|23.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||23.47|1.33|0.0186
71141878|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.37||||0.1434|TWO_SIDED|95.0|0.75|7.56||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||7.56|0.75|0.1434
71141879|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.2||||0.167|TWO_SIDED|95.0|0.72|6.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.75|0.72|0.1670
71141880|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|1.16||||0.781|TWO_SIDED|95.0|0.41|3.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.28|0.41|0.7810
71141881|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.27||||0.1682|TWO_SIDED|95.0|0.71|7.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||7.26|0.71|0.1682
71141882|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|5.22||||0.0215|TWO_SIDED|95.0|1.28|21.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||21.39|1.28|0.0215
71141883|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|4.75||||0.0306|TWO_SIDED|95.0|1.16|19.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||19.52|1.16|0.0306
71141884|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|10.1||||0.0059|TWO_SIDED|95.0|1.92|52.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||52.29|1.92|0.0059
71141885|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.64||||0.1004|TWO_SIDED|95.0|0.83|8.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.43|0.83|0.1004
70950303|NCT00667459|141401805|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.019||||1|TWO_SIDED|95.0|-0.018|0.058||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.058|-0.018|1.0
71141886|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.11||||0.1837|TWO_SIDED|95.0|0.7|6.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.36|0.70|0.1837
71141887|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|1.33||||0.5929|TWO_SIDED|95.0|0.47|3.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.75|0.47|0.5929
71141888|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|1.93||||0.2588|TWO_SIDED|95.0|0.62|6.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.07|0.62|0.2588
71141889|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|7.69||||0.0129|TWO_SIDED|95.0|1.54|38.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||38.41|1.54|0.0129
71141890|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|7.12||||0.0168|TWO_SIDED|95.0|1.42|35.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||35.61|1.42|0.0168
71141891|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|9.95||||0.0058|TWO_SIDED|95.0|1.94|50.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||50.97|1.94|0.0058
71141892|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1934|TWO_SIDED|95.0|0.69|6.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.26|0.69|0.1934
71141893|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.01||||0.2181|TWO_SIDED|95.0|0.66|6.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.12|0.66|0.2181
71141894|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|1.58||||0.4116|TWO_SIDED|95.0|0.53|4.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.71|0.53|0.4116
71141895|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.84||||0.0938|TWO_SIDED|95.0|0.84|9.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||9.66|0.84|0.0938
71141896|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|8.02||||0.0125|TWO_SIDED|95.0|1.57|41.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||41.08|1.57|0.0125
71141897|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|3.29||||0.0761|TWO_SIDED|95.0|0.88|12.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||12.23|0.88|0.0761
71141898|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|4.02||||0.0305|TWO_SIDED|95.0|1.14|14.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||14.16|1.14|0.0305
71141899|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|3.42||||0.0501|TWO_SIDED|95.0|1.0|11.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||11.68|1.00|0.0501
71141900|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.61||||0.1212|TWO_SIDED|95.0|0.78|8.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||8.77|0.78|0.1212
71141901|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|1.13||||0.8332|TWO_SIDED|95.0|0.35|3.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.68|0.35|0.8332
70867527|NCT00434954|141221065|NON_INFERIORITY_OR_EQUIVALENCE|The planned sample size of 366 patients treated with metformin only (assuming 25% dropouts) gave a power of 85% to detect non-inferiority of exenatide BID for change in HbA1c (non-inferiority margin 0.4%; assumed common standard deviation of 1.1%).|Mean Difference (Net)|0.14||||0.055|TWO_SIDED|95.0|-0.003|0.291||Non-inferiority: upper limit of 95% Confidence Interval (CI) to be \< 0.4%.|Mixed effect model repeat measures(MMRM)|95% CI of treatment group difference derived from MMRM (treatment, week, baseline HbA1c and interactions as fixed effects); p-value: superiority test||The hypothesis was tested hierarchically that 1) exenatide BID is non-inferior to insulin aspart 70/30 BID for glycemic control (change in HbA1c, outcome measure 1), and 2) superior regarding the incidence of hypoglycemia (outcome measure 2). This is the first part of the hierarchical test.||0.291|-0.003|0.055
70867528|NCT00434954|141221066|SUPERIORITY_OR_OTHER|||||||0.554||95.0|||||Chi square test (Pearson)|||||||0.554
70867529|NCT00434954|141221067|SUPERIORITY_OR_OTHER|||||||0.159||95.0|||||Chi square test (Pearson)|||||||0.159
70867530|NCT00434954|141221072|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Non overlapping 95% CI's: statistically significant difference p\<0.05.|Kaplan-Meier analysis|For each treatment group, the incidence of hypoglycemia at Week 26 and 95% CIs were derived from Kaplan-Meier analysis.||The hypothesis was tested hierarchically that 1) exenatide BID is non-inferior to insulin aspart BID for glycemic control (outcome measure 1), and 2) superior regarding the incidence of hypoglycemia (outcome measure 2).The planned sample size of 366 patients treated with metformin only (assumed dropout rate 25%) gave 96% power to detect superiority of exenatide BID for the risk of hypoglycemia, assuming incidences of 3.6% for exenatide BID and 17.5% for insulin aspart BID (alpha=0.05).||||<0.05
70867531|NCT00434954|141221073|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The MMRM model adjusted for baseline HbA1c stratum (HbA1c at baseline \>= 6.5% and \<= 8.0% vs. \> 8.0% and \<=10%).|Mixed effects model repeated measures|95% CI of treatment group difference derived from MMRM (treatment, week, baseline HbA1c and interactions as fixed effects)||||||<0.0001
70867532|NCT00434954|141221074|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The MMRM model adjusted for baseline HbA1c stratum (HbA1c at Visit 1 \>= 6.5% and \<= 8.0% vs. \> 8.0% and \<=10%).|Mixed effects model repeated measures|95% CI of treatment group difference derived from MMRM (treatment, week, baseline HbA1c and interactions as fixed effects)||||||<0.0001
70867533|NCT00944671|141221081|NON_INFERIORITY_OR_EQUIVALENCE|Given a 3-period crossover design, assuming a true within subject variance for natural log AUC of 0.029, 24 subjects completing the study, and alpha = 0.05, there is a 0.995 probability that the 90% confidence interval for the true geometric mean ratio of AUC for (famotidine antacid combination EZ Chew tablet without water/ famotidine antacid combination tablet with water) will be contained in (0.80, 1.25), given that the true ratio is one.|Geometric Mean Ratio|1.05||||||90.0|0.98|1.13||||||||1.13|0.98|
70867534|NCT00944671|141221082|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a true within subject variance for natural log Cmax of 0.017, there is a 0.999 probability that the 90% confidence interval for the true geometric mean ratio of Cmax for (famotidine antacid combination EZ Chew tablet without water/ famotidine antacid combination tablet with water) will be contained in (0.80, 1.25), given that the true ratio is one.|Geometric Mean Ratio|1.03||||||90.0|0.93|1.13||||||||1.13|0.93|
70867535|NCT00944671|141221083|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.05||||||90.0|0.98|1.13||||||||1.13|0.98|
70867536|NCT00944671|141221084|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.03||||||90.0|0.93|1.14||||||||1.14|0.93|
70867537|NCT00142935|141221092|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared, Corrected|||Outcome: engage in treatment post release, yes or no||||<0.001
70867538|NCT00142935|141221093|SUPERIORITY_OR_OTHER|||||||0.02|||||||Chi-squared, Corrected|||||||.02
70867539|NCT00142935|141221094|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Chi-squared, Corrected|||||||.09
70867540|NCT00142935|141221095|SUPERIORITY_OR_OTHER|||||||0.09|||||||Chi-squared, Corrected|||||||.09
70950304|NCT00667459|141401805|SUPERIORITY_OR_OTHER_LEGACY|||||||0.845||95.0||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||0.845
70867541|NCT00142935|141221097|SUPERIORITY_OR_OTHER|||||||0.8|||||||Chi-squared, Corrected|||||||0.8
70867542|NCT03055156|141221105|OTHER|||||||0.6|||||||t-test, 2 sided|||||||0.60
70867543|NCT03055156|141221106|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
70867544|NCT03055156|141221107|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
70867545|NCT03055156|141221108|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
70867546|NCT03055156|141221109|OTHER|||||||0.02|||||||t-test, 2 sided|||Analysis of Wake values||||0.02
71141902|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|1.66||||0.4285|TWO_SIDED|95.0|0.48|5.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.76|0.48|0.4285
70867547|NCT03055156|141221109|OTHER|||||||0.06|||||||t-test, 2 sided|||Analysis of REM values||||0.06
70867548|NCT03055156|141221109|OTHER|||||||0.83|||||||t-test, 2 sided|||Analysis of Non REM stage 1 values||||0.83
70867549|NCT03055156|141221109|OTHER|||||||0.87|||||||t-test, 2 sided|||Analysis of Non REM stage 2 values||||0.87
70867550|NCT03055156|141221109|OTHER|||||||0.97|||||||t-test, 2 sided|||Analysis of Non REM stage 3 values||||0.97
70867551|NCT03055156|141221110|OTHER|||||||0.38|||||||t-test, 2 sided|||||||0.38
70867552|NCT03055156|141221111|OTHER|||||||0.96|||||||t-test, 2 sided|||||||0.96
70867553|NCT03055156|141221113|OTHER|||||||0.55|||||||t-test, 2 sided|||||||0.55
70867554|NCT03055156|141221114|OTHER|||||||0.86|||||||t-test, 2 sided|||analysis of 0-90 minutes||||0.86
70867555|NCT03055156|141221114|OTHER|||||||0.29|||||||t-test, 2 sided|||analysis of 90-180 minutes||||0.29
70867556|NCT03055156|141221114|OTHER|||||||0.58|||||||t-test, 2 sided|||analysis of 180-270 minutes||||0.58
70867557|NCT03055156|141221114|OTHER|||||||0.62|||||||t-test, 2 sided|||analysis of 270-360 min||||0.62
70867558|NCT03055156|141221115|OTHER|||||||0.389|||||||ANOVA|||Implemented two-way mixed ANOVA with time as within-subject variable and topper type as between-subject variable. This is to compare the difference in core body temperature trend over time between the two study arms. Interaction between time and topper type on CBT was calculated.||||0.389
70867559|NCT03055156|141221115|OTHER|||||||0.01|||||||ANOVA|||Implemented two-way mixed ANOVA with time as within-subject variable and topper type as between-subject variable. This is to see the effect over time from both study arms on CBT. Main effect of time on CBT.||||0.01
70950305|NCT00667459|141401806|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.047||||0.936|TWO_SIDED|95.0|-0.113|0.021||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.021|-0.113|0.936
70950306|NCT00667459|141401807|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.105||||1|TWO_SIDED|95.0|0.02|0.19||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.190|0.020|1.0
70950307|NCT00667459|141401807|SUPERIORITY_OR_OTHER_LEGACY|||||||0.992||95.0||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||0.992
70950308|NCT00667459|141401809|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|||Superiority comparison of the operative time in two treatment groups was assessed.||||0.013
70950309|NCT00667459|141401810|SUPERIORITY_OR_OTHER_LEGACY|||||||0.769||||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|||Superiority comparison of the blood loss in two treatment groups was assessed.||||0.769
71141903|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.98||||0.0954|TWO_SIDED|95.0|0.83|10.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||10.74|0.83|0.0954
71141904|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.98||||0.111|TWO_SIDED|95.0|0.78|11.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||11.38|0.78|0.1110
71141905|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.44||||0.1642|TWO_SIDED|95.0|0.69|8.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||8.55|0.69|0.1642
71141906|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|2.19||||0.1976|TWO_SIDED|95.0|0.66|7.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.24|0.66|0.1976
71141907|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|1.4||||0.5761|TWO_SIDED|95.0|0.43|4.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.58|0.43|0.5761
71141908|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|0.64||||0.454|TWO_SIDED|95.0|0.2|2.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.04|0.20|0.4540
71141909|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|0.57||||0.3732|TWO_SIDED|95.0|0.17|1.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.96|0.17|0.3732
71141910|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|1.59||||0.4665|TWO_SIDED|95.0|0.46|5.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.50|0.46|0.4665
71141911|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|1.46||||0.5634|TWO_SIDED|95.0|0.41|5.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.25|0.41|0.5634
71141912|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|1.65||||0.4297|TWO_SIDED|95.0|0.48|5.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.70|0.48|0.4297
71141913|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9789|TWO_SIDED|95.0|0.31|3.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.14|0.31|0.9789
71141914|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|0.81||||0.7357|TWO_SIDED|95.0|0.24|2.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.70|0.24|0.7357
71141915|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|0.46||||0.1977|TWO_SIDED|95.0|0.14|1.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.50|0.14|0.1977
71141916|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|0.52||||0.3203|TWO_SIDED|95.0|0.14|1.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.88|0.14|0.3203
71141917|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9739|TWO_SIDED|95.0|0.3|3.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.44|0.30|0.9739
71141918|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|1.33||||0.6714|TWO_SIDED|95.0|0.36|4.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||4.97|0.36|0.6714
70950310|NCT00667459|141401811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.273||||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|||Superiority comparison of the hospital stay in two treatment groups was assessed.||||0.273
71141919|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|0.75||||0.6375|TWO_SIDED|95.0|0.22|2.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.52|0.22|0.6375
70867560|NCT03055156|141221115|OTHER|||||||0.642|||||||ANOVA|||Implemented two-way mixed ANOVA with time as within-subject variable and topper type as between-subject variable. This is to see the effect of the intervention on CBT including all time points. Main effect of topper type on CBT.||||0.642
70950311|NCT04546217|141401827|SUPERIORITY|Since this is a descriptive analysis, no power calculation was conducted.||||||||||||||||Considering the small sample size, a descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits.|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits. Changes in the scores obtained on all time points compared to pre-treatment were also identified.|||
70950312|NCT04546217|141401828|OTHER|Since this is a descriptive analysis, no power calculation was conducted.||||||||||||||||Considering the small sample size, a descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits.|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessment visits. Changes in the scores obtained on all time points compared to pre-treatment were also identified.|||
70950313|NCT04546217|141401829|OTHER|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits.||||||||||||||||Considering the small sample size, a descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits.|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessment visits. Changes in the scores obtained on all time points compared to pre-treatment were also identified.|||
70950314|NCT04546217|141401830|OTHER|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits. Changes in scores post-treatment vs. pre-treatment, and 3 and 6-month follow up vs. post-treatment were calculated.|||||||||||||||||A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessment visits. Changes in the scores obtained on all time points compared to pre-treatment were also identified.|||
70950315|NCT04546217|141401831|OTHER|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits. Changes in scores post-treatment vs. pre-treatment, and 3 and 6-month follow up vs. post-treatment were calculated.|||||||||||||||||A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessment visits. Changes in the scores obtained on all time points compared to pre-treatment were also identified.|||
70950316|NCT04546217|141401832|OTHER|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits. Changes in scores post-treatment vs. pre-treatment, and 3 and 6-month follow up vs. post-treatment were calculated.|||||||||||||||||A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessment visits. Changes in the scores obtained on all time points compared to pre-treatment were also identified.|||
70867561|NCT03055156|141221116|OTHER|||||||0.61|||||||t-test, 2 sided|||||||0.61
70867562|NCT03055156|141221117|OTHER|||||||0.71|||||||t-test, 2 sided|||||||0.71
71141920|NCT03192176|141778539|SUPERIORITY||Odds Ratio (OR)|0.54||||0.298|TWO_SIDED|95.0|0.17|1.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.71|0.17|0.2980
71141921|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|5.35||||0.0044|TWO_SIDED|95.0|1.69|16.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.96|1.69|0.0044
71141922|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|8.65||||0.0002|TWO_SIDED|95.0|2.79|26.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||26.83|2.79|0.0002
71141923|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|10.82|||<|0.0001|TWO_SIDED|95.0|3.49|33.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||33.54|3.49|<0.0001
71141924|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|10.01|||<|0.0001|TWO_SIDED|95.0|3.2|31.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||31.29|3.20|<0.0001
71141925|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.51||||0.1266|TWO_SIDED|95.0|0.77|8.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||8.15|0.77|0.1266
71141926|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|5.72||||0.0024|TWO_SIDED|95.0|1.85|17.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||17.66|1.85|0.0024
71141927|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|7.93||||0.0003|TWO_SIDED|95.0|2.59|24.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||24.26|2.59|0.0003
71141928|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|3.11||||0.0217|TWO_SIDED|95.0|1.18|8.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.17|1.18|0.0217
71141929|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|4.63||||0.0021|TWO_SIDED|95.0|1.75|12.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.25|1.75|0.0021
71141930|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|4.72||||0.0016|TWO_SIDED|95.0|1.8|12.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.37|1.80|0.0016
71141931|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|4.8||||0.0018|TWO_SIDED|95.0|1.79|12.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.86|1.79|0.0018
71141932|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.69||||0.0467|TWO_SIDED|95.0|1.01|7.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.14|1.01|0.0467
71141933|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|4.7||||0.0016|TWO_SIDED|95.0|1.8|12.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.28|1.80|0.0016
71141934|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.98||||0.0234|TWO_SIDED|95.0|1.16|7.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.65|1.16|0.0234
71141935|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.88||||0.0294|TWO_SIDED|95.0|1.11|7.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.46|1.11|0.0294
71141936|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|3.74||||0.0068|TWO_SIDED|95.0|1.44|9.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.73|1.44|0.0068
71141937|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|4.35||||0.0025|TWO_SIDED|95.0|1.68|11.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||11.29|1.68|0.0025
70867563|NCT03055156|141221118|OTHER|||||||1|||||||t-test, 2 sided|||||||1.00
70950317|NCT01888874|141401855|SUPERIORITY||Difference in percentage rates|11.9||||0.1236|TWO_SIDED|95.0|-3.1|26.9|||Regression, Logistic|P-value has been corrected for multiplicity according to Hommel's closed-testing method.||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||26.9|-3.1|0.1236
70950318|NCT01888874|141401855|SUPERIORITY||Difference in percentage rates|19.3||||0.0435|TWO_SIDED|95.0|4.7|34.0||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||34|4.7|0.0435
71141938|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|5.82||||0.0006|TWO_SIDED|95.0|2.13|15.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||15.92|2.13|0.0006
71141939|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.53||||0.0572|TWO_SIDED|95.0|0.97|6.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.61|0.97|0.0572
71141940|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|6.03||||0.0003|TWO_SIDED|95.0|2.28|15.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||15.97|2.28|0.0003
71141941|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.55||||0.046|TWO_SIDED|95.0|1.02|6.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.38|1.02|0.0460
71141942|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.03||||0.1406|TWO_SIDED|95.0|0.79|5.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.23|0.79|0.1406
71141943|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.97||||0.0234|TWO_SIDED|95.0|1.16|7.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.63|1.16|0.0234
71141944|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.82||||0.0302|TWO_SIDED|95.0|1.1|7.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.22|1.10|0.0302
71141945|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|5.23||||0.0016|TWO_SIDED|95.0|1.87|14.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||14.63|1.87|0.0016
71141946|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|1.82||||0.2105|TWO_SIDED|95.0|0.71|4.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||4.64|0.71|0.2105
71141947|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|4.17||||0.0033|TWO_SIDED|95.0|1.61|10.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.81|1.61|0.0033
71141948|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.1||||0.1087|TWO_SIDED|95.0|0.85|5.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.21|0.85|0.1087
71141949|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|1.56||||0.36|TWO_SIDED|95.0|0.6|4.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.03|0.60|0.3600
71141950|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.05||||0.1394|TWO_SIDED|95.0|0.79|5.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.32|0.79|0.1394
70950319|NCT01888874|141401855|SUPERIORITY||Difference in percentage rates|24.4||||0.0068|TWO_SIDED|95.0|10.1|38.8||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||38.8|10.1|0.0068
70950320|NCT01888874|141401855|SUPERIORITY||Difference in percentage rates|12.8||||0.1236|TWO_SIDED|95.0|-2.0|27.6||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||27.6|-2|0.1236
71141951|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0522|TWO_SIDED|95.0|0.99|7.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.36|0.99|0.0522
71141952|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|3.97||||0.0119|TWO_SIDED|95.0|1.63|11.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||11.61|1.63|0.0119
71141953|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.07||||0.1474|TWO_SIDED|95.0|0.77|5.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.53|0.77|0.1474
70950321|NCT01888874|141401855|SUPERIORITY||Difference in percentage rates|15.8||||0.1056|TWO_SIDED|95.0|1.0|30.6||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||30.6|1|0.1056
71141954|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|5.08||||0.0026|TWO_SIDED|95.0|1.76|14.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||14.67|1.76|0.0026
71141955|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.11||||0.1263|TWO_SIDED|95.0|0.81|5.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.51|0.81|0.1263
71141956|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|1.83||||0.2327|TWO_SIDED|95.0|0.68|4.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||4.95|0.68|0.2327
70867564|NCT01431989|141221125|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis. This is a bioequivalence study performed to support the register of Clamoxyl 500 mg/5 mL, according to the requirements of Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio Geometric mean T/R formulation|90.03|STANDARD_DEVIATION|7.53||0|TWO_SIDED|90.0|86.99|93.17|||ANOVA|ANOVA model: 1) Fixed effects: Sequence, Period, and Formulation; 2) Random effects: Volunteer (Sequence) and Residual|The ratio between the geometric means of the test (T) and reference (R) formulations was calculated. Standard deviation intra subject was obtained.|||93.17|86.99|0.0000
70867565|NCT01431989|141221126|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis. This is a bioequivalence study performed to support the register of Clamoxyl 500 mg/5 mL, according to the requirements of Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio Geometric mean T/R formulation|87.93|STANDARD_DEVIATION|13.83||0.0018|TWO_SIDED|90.0|82.55|93.65|||ANOVA|ANOVA model: 1) Fixed effects: Sequence, Period, and Formulation; 2) Random effects: Volunteer (Sequence) and Residual|The ratio between the geometric means of the test (T) and reference (R) formulations was calculated. Standard deviation intra subject was obtained.|||93.65|82.55|0.0018
70867566|NCT01431989|141221127|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis. This is a bioequivalence study performed to support the register of Clamoxyl 500 mg/5 mL, according to the requirements of Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio Geometric means T/R formulation|90.03|STANDARD_DEVIATION|7.51||0|TWO_SIDED|90.0|86.96|93.12|||ANOVA|ANOVA model: 1) Fixed effects: Sequence, Period, and Formulation; 2) Random effects: Volunteer (Sequence) and Residual|The ratio between the geometric means of the test (T) and reference (R) formulations was calculated. Standard deviation intra subject was obtained.|||93.12|86.96|0.0000
70867567|NCT01431989|141221128|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis. This is a bioequivalence study performed to support the register of Clamoxyl 500 mg/5 mL, according to the requirements of Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Median Difference (Final Values)|0.125||||0.339|TWO_SIDED|90.0|-0.125|0.375|||Wilcoxon (Mann-Whitney)|The non-parametric method included the following factors: Sequence, Formulation, Period, Formulation and Residual||||0.375|-0.125|0.3390
70867568|NCT03345914|141221150|SUPERIORITY||Percentage difference|18.1|||=|0.0004|TWO_SIDED|95.0|8.28|27.97||The Cochran-Mantel-Haenszel (CMH) test adjusted by randomization strata (baseline weight group (\< 30 kilograms (kg) or ≥ 30 kg) and region (North America or Europe) was used for the analysis of percentage of participants with IGA 0 or 1 at Week 16.|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||27.97|8.28|= 0.0004
70867569|NCT03345914|141221150|SUPERIORITY||Percentage difference|21.4|||<|0.0001|TWO_SIDED|95.0|11.36|31.45||The Cochran-Mantel-Haenszel (CMH) test adjusted by randomization strata (baseline weight group (\< 30 kg or ≥ 30 kg) and region (North America or Europe) was used for the analysis of percentage of participants with IGA 0 or 1 at Week 16.|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||31.45|11.36|< 0.0001
70867570|NCT03345914|141221151|SUPERIORITY||Percentage difference|40.4|||<|0.0001|TWO_SIDED|95.0|28.95|51.82||The Cochran-Mantel-Haenszel (CMH) test adjusted by randomization strata (baseline weight group (\< 30 kg or ≥ 30 kg) and region (North America or Europe) was used for the analysis of percentage of participants with EASI-75 at Week 16.|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||51.82|28.95|< 0.0001
70950322|NCT01888874|141401855|SUPERIORITY||Difference in percentage rates|34.4|||<|0.0001|TWO_SIDED|95.0|20.7|48.1||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||48.1|20.7|< 0.0001
70867571|NCT03345914|141221151|SUPERIORITY||Percentage difference|42.8|||<|0.0001|TWO_SIDED|95.0|31.54|54.15||The Cochran-Mantel-Haenszel (CMH) test adjusted by randomization strata (baseline weight group (\< 30 kg or ≥ 30 kg) and region (North America or Europe) was used for the analysis of percentage of participants with EASI-75 at Week 16.|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||54.15|31.54|< 0.0001
70867572|NCT03345914|141221152|SUPERIORITY||Least Square Mean Difference|-29.8|||<|0.0001|TWO_SIDED|95.0|-36.33|-23.24||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-23.24|-36.33|< 0.0001
70872211|NCT01727297|141229672|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.21|TWO_SIDED|95.0|0.53|1.15||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having coronary artery disease on a patient's risk of developing AF.|The null hypothesis was that coronary artery disease did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.15|0.53|0.21
70950323|NCT00475644|141401898|SUPERIORITY||Odds Ratio (OR)|0.031|||||TWO_SIDED|95.0|0.001|0.86||||||||0.860|0.001|
71141957|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.12||||0.1359|TWO_SIDED|95.0|0.79|5.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.70|0.79|0.1359
71141958|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|3.35||||0.0258|TWO_SIDED|95.0|1.16|9.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.69|1.16|0.0258
71141959|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|4.77||||0.0076|TWO_SIDED|95.0|1.51|15.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||15.04|1.51|0.0076
71141960|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.36||||0.1088|TWO_SIDED|95.0|0.83|6.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.75|0.83|0.1088
71141961|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|4.89||||0.0045|TWO_SIDED|95.0|1.64|14.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||14.62|1.64|0.0045
71141962|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.74||||0.0493|TWO_SIDED|95.0|1.0|7.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.50|1.00|0.0493
71141963|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.99||||0.0376|TWO_SIDED|95.0|1.06|8.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||8.41|1.06|0.0376
71141964|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.53||||0.0723|TWO_SIDED|95.0|0.92|6.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.94|0.92|0.0723
71141965|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|3.11||||0.0396|TWO_SIDED|95.0|1.06|9.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.17|1.06|0.0396
71141966|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|6.18||||0.0031|TWO_SIDED|95.0|1.85|20.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||20.67|1.85|0.0031
71141967|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.41||||0.1044|TWO_SIDED|95.0|0.83|6.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.96|0.83|0.1044
71141968|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|5.47||||0.0029|TWO_SIDED|95.0|1.78|16.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||16.75|1.78|0.0029
71141969|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|3.01||||0.0364|TWO_SIDED|95.0|1.07|8.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||8.45|1.07|0.0364
71141970|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|1.26||||0.6396|TWO_SIDED|95.0|0.47|3.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.37|0.47|0.6396
71141971|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|1.47||||0.4378|TWO_SIDED|95.0|0.55|3.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.91|0.55|0.4378
71141972|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|1.95||||0.2045|TWO_SIDED|95.0|0.7|5.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.44|0.70|0.2045
71141973|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.54||||0.0958|TWO_SIDED|95.0|0.85|7.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.62|0.85|0.0958
71141974|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|1.7||||0.321|TWO_SIDED|95.0|0.6|4.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.85|0.60|0.3210
71141975|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|3.75||||0.0199|TWO_SIDED|95.0|1.23|11.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||11.39|1.23|0.0199
70867573|NCT03345914|141221152|SUPERIORITY||Least Square Mean Difference|-33.4|||<|0.0001|TWO_SIDED|95.0|-40.06|-26.82||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-26.82|-40.06|< 0.0001
70867574|NCT03345914|141221153|SUPERIORITY||Least Square Mean Difference|-31.0|||<|0.0001|TWO_SIDED|95.0|-38.76|-23.26||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-23.26|-38.76|< 0.0001
70867575|NCT03345914|141221153|SUPERIORITY||Least Square Mean Difference|-28.6|||<|0.0001|TWO_SIDED|95.0|-36.47|-20.82||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-20.82|-36.47|< 0.0001
70867576|NCT03345914|141221154|SUPERIORITY||Percentage difference|46.4|||<|0.0001|TWO_SIDED|95.0|35.3|57.42||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||57.42|35.3|< 0.0001
70867577|NCT03345914|141221154|SUPERIORITY||Percentage difference|39.2|||<|0.0001|TWO_SIDED|95.0|27.88|50.51||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||50.51|27.88|< 0.0001
70867578|NCT03345914|141221155|SUPERIORITY||Percentage difference|46.0|||<|0.0001|TWO_SIDED|95.0|35.47|56.61||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||56.61|35.47|< 0.0001
70867579|NCT03345914|141221155|SUPERIORITY||Percentage difference|38.5|||<|0.0001|TWO_SIDED|95.0|27.86|49.21||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||49.21|27.86|< 0.0001
70867580|NCT03345914|141221156|SUPERIORITY||Percentage difference|39.7|||<|0.0001|TWO_SIDED|95.0|28.68|50.72||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||50.72|28.68|< 0.0001
70867581|NCT03345914|141221156|SUPERIORITY||Percentage difference|47.9|||<|0.0001|TWO_SIDED|95.0|37.77|58.01||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||58.01|37.77|< 0.0001
70867582|NCT03345914|141221157|SUPERIORITY||Percentage difference|23.0|||<|0.0001|TWO_SIDED|95.0|13.65|32.38||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||32.38|13.65|< 0.0001
70867583|NCT03345914|141221157|SUPERIORITY||Percentage difference|34.5|||<|0.0001|TWO_SIDED|95.0|24.6|44.37||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||44.37|24.6|< 0.0001
71141976|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.26||||0.1219|TWO_SIDED|95.0|0.8|6.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.36|0.80|0.1219
70867584|NCT03345914|141221158|SUPERIORITY||Hazard ratios|3.114|||<|0.0001|TWO_SIDED|95.0|2.097|4.624||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cox model|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||4.624|2.097|< 0.0001
71141977|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|1.72||||0.2975|TWO_SIDED|95.0|0.62|4.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.76|0.62|0.2975
70867585|NCT03345914|141221158|SUPERIORITY||Hazard ratios|2.921|||<|0.0001|TWO_SIDED|95.0|1.957|4.36||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cox model|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||4.36|1.957|< 0.0001
71141978|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|1.75||||0.2763|TWO_SIDED|95.0|0.64|4.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.80|0.64|0.2763
71141979|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.33||||0.1235|TWO_SIDED|95.0|0.79|6.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.82|0.79|0.1235
71141980|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|4.24||||0.019|TWO_SIDED|95.0|1.27|14.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||14.19|1.27|0.0190
71141981|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|1.98||||0.2213|TWO_SIDED|95.0|0.66|5.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.93|0.66|0.2213
71141982|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|5.88||||0.005|TWO_SIDED|95.0|1.71|20.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||20.25|1.71|0.0050
71141983|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.39||||0.1053|TWO_SIDED|95.0|0.83|6.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.85|0.83|0.1053
71141984|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.39||||0.0991|TWO_SIDED|95.0|0.85|6.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.72|0.85|0.0991
71141985|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|1.93||||0.2056|TWO_SIDED|95.0|0.7|5.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.32|0.70|0.2056
71141986|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|3.17||||0.0407|TWO_SIDED|95.0|1.05|9.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||9.57|1.05|0.0407
71141987|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|5.47||||0.0059|TWO_SIDED|95.0|1.63|18.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||18.30|1.63|0.0059
71141988|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|3.85||||0.023|TWO_SIDED|95.0|1.2|12.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||12.30|1.20|0.0230
71141989|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|7.36||||0.0015|TWO_SIDED|95.0|2.14|25.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||25.29|2.14|0.0015
71141990|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|3.45||||0.0248|TWO_SIDED|95.0|1.17|10.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.16|1.17|0.0248
71141991|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.37||||0.1091|TWO_SIDED|95.0|0.82|6.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.83|0.82|0.1091
70867586|NCT03345914|141221159|SUPERIORITY||Hazard ratios|2.278|||<|0.0001|TWO_SIDED|95.0|1.631|3.182||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cox model|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||3.182|1.631|< 0.0001
70867587|NCT03345914|141221159|SUPERIORITY||Hazard ratios|2.075|||<|0.0001|TWO_SIDED|95.0|1.481|2.908||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cox model|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||2.908|1.481|< 0.0001
70867588|NCT03345914|141221160|SUPERIORITY||Least Square Mean Difference|-17.72|||<|0.0001|TWO_SIDED|95.0|-22.272|-13.161||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-13.161|-22.272|< 0.0001
70867589|NCT03345914|141221160|SUPERIORITY||Least Square Mean Difference|-18.88|||<|0.0001|TWO_SIDED|95.0|-23.479|-14.289||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-14.289|-23.479|< 0.0001
70867590|NCT03345914|141221161|SUPERIORITY||Least Square Mean Difference|-30.4|||<|0.0001|TWO_SIDED|95.0|-36.3|-24.48||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-24.48|-36.3|< 0.0001
70867591|NCT03345914|141221161|SUPERIORITY||Least Square Mean Difference|-32.6|||<|0.0001|TWO_SIDED|95.0|-38.57|-26.59||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-26.59|-38.57|< 0.0001
70867592|NCT03345914|141221162|SUPERIORITY||Least Square Mean Difference|-4.3|||<|0.0001|TWO_SIDED|95.0|-5.62|-2.99||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-2.99|-5.62|< 0.0001
70867593|NCT03345914|141221162|SUPERIORITY||Least Square Mean Difference|-4.2|||<|0.0001|TWO_SIDED|95.0|-5.57|-2.89||The confidence interval (CI) with p-value was based on treatment difference (dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-2.89|-5.57|< 0.0001
70867594|NCT03345914|141221163|SUPERIORITY||Least Square Mean Difference|-8.1|||<|0.0001|TWO_SIDED|95.0|-9.96|-6.31||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-6.31|-9.96|< 0.0001
70867595|NCT03345914|141221163|SUPERIORITY||Least Square Mean Difference|-8.3|||<|0.0001|TWO_SIDED|95.0|-10.13|-6.43||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-6.43|-10.13|< 0.0001
70867596|NCT03345914|141221164|SUPERIORITY||Least Square Mean Difference|-2.41|||<|0.0001|TWO_SIDED|95.0|-2.984|-1.831||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-1.831|-2.984|< 0.0001
70867597|NCT03345914|141221164|SUPERIORITY||Least Square Mean Difference|-2.18|||<|0.0001|TWO_SIDED|95.0|-2.754|-1.599||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-1.599|-2.754|< 0.0001
70867598|NCT03345914|141221165|SUPERIORITY||Least Square Mean Difference|-4.11|||<|0.0001|TWO_SIDED|95.0|-5.434|-2.796||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-2.796|-5.434|< 0.0001
70867599|NCT03345914|141221165|SUPERIORITY||Least Square Mean Difference|-3.98|||<|0.0001|TWO_SIDED|95.0|-5.298|-2.657||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-2.657|-5.298|< 0.0001
70867600|NCT03345914|141221166|SUPERIORITY||Least Square Mean Difference|-3.37|||=|0.0061|TWO_SIDED|95.0|-5.779|-0.962||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-0.962|-5.779|= 0.0061
70867601|NCT03345914|141221166|SUPERIORITY||Least Square Mean Difference|-3.02|||=|0.0133|TWO_SIDED|95.0|-5.414|-0.629||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-0.629|-5.414|= 0.0133
70867602|NCT03345914|141221167|SUPERIORITY||Least Square Mean Difference|-4.5|||<|0.0001|TWO_SIDED|95.0|-6.734|-2.272||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-2.272|-6.734|< 0.0001
70867603|NCT03345914|141221167|SUPERIORITY||Least Square Mean Difference|-5.42|||<|0.0001|TWO_SIDED|95.0|-7.641|-3.207||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-3.207|-7.641|< 0.0001
70867604|NCT03345914|141221168|SUPERIORITY||Percentage Differenece|-4.8|||=|0.222|TWO_SIDED|95.0|-12.49|2.87||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||2.87|-12.49|= 0.222
70867605|NCT03345914|141221168|SUPERIORITY||Percentage Differenece|-7.3|||=|0.0508|TWO_SIDED|95.0|-14.51|-0.03||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-0.03|-14.51|= 0.0508
70867606|NCT03345914|141221171|SUPERIORITY||Least Square Mean Difference|-5.7|||=|0.003|TWO_SIDED|95.0|-9.49|-1.96||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANOVA model with the treatment, randomization strata as fixed factors.|ANOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level||-1.96|-9.49|= 0.003
70867607|NCT03345914|141221171|SUPERIORITY|A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level|Least Square Mean Difference|-5.1|||=|0.0082|TWO_SIDED|95.0|-8.8|-1.31||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANOVA model with the treatment, randomization strata as fixed factors.|ANOVA|||||-1.31|-8.8|= 0.0082
70950324|NCT01411241|141401899|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% Confidence Interval (CI) of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.48|1.4||||||Non-inferiority (Group 1 - Group 2); Anti-diphtheria. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||1.40|-1.48|
70950325|NCT01411241|141401899|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.37|||||TWO_SIDED|95.0|-1.14|2.07||||||Non-inferiority (Group 1 - Group 2); Anti-tetanus. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||2.07|-1.14|
71141992|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|1.71||||0.3054|TWO_SIDED|95.0|0.61|4.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.75|0.61|0.3054
71141993|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.48||||0.1129|TWO_SIDED|95.0|0.81|7.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.61|0.81|0.1129
71141994|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|3.28||||0.0432|TWO_SIDED|95.0|1.04|10.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||10.37|1.04|0.0432
71141995|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|3.77||||0.0315|TWO_SIDED|95.0|1.13|12.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||12.60|1.13|0.0315
71141996|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|4.26||||0.0147|TWO_SIDED|95.0|1.33|13.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||13.64|1.33|0.0147
71141997|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|3.18||||0.0405|TWO_SIDED|95.0|1.05|9.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.59|1.05|0.0405
71141998|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|1.4||||0.5238|TWO_SIDED|95.0|0.5|3.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.93|0.50|0.5238
71141999|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|1.73||||0.306|TWO_SIDED|95.0|0.6|4.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.97|0.60|0.3060
71142000|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|1.64||||0.3747|TWO_SIDED|95.0|0.55|4.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.86|0.55|0.3747
71142001|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|3.49||||0.0443|TWO_SIDED|95.0|1.03|11.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||11.80|1.03|0.0443
71142002|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.49||||0.1269|TWO_SIDED|95.0|0.77|8.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.06|0.77|0.1269
71142003|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|5.15||||0.0095|TWO_SIDED|95.0|1.49|17.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||17.13|1.49|0.0095
71142004|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.34||||0.1254|TWO_SIDED|95.0|0.79|6.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.94|0.79|0.1254
71142005|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|3.66||||0.0402|TWO_SIDED|95.0|1.06|12.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||12.63|1.06|0.0402
71142006|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|1.59||||0.4547|TWO_SIDED|95.0|0.47|5.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.42|0.47|0.4547
71142007|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|1.71||||0.4008|TWO_SIDED|95.0|0.49|5.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.99|0.49|0.4008
70950326|NCT01411241|141401899|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.37|||||TWO_SIDED|95.0|-1.14|2.08||||||Non-inferiority (Group 1 - Group 2); Anti-polio 1. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||2.08|-1.14|
70950327|NCT01411241|141401899|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.48|1.4||||||Non-inferiority (Group 1 - Group 2); Anti-polio 2. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||1.40|-1.48|
70950328|NCT01411241|141401899|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.37|||||TWO_SIDED|95.0|-1.15|2.09||||||Non-inferiority (Group 1 - Group 2); Anti-polio 3. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||2.09|-1.15|
70950329|NCT01411241|141401899|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.48|1.4||||||Non-inferiority (Group 1 - Group 2); Anti-PRP. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||1.40|-1.48|
70950330|NCT01411241|141401899|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|-0.56|||||TWO_SIDED|95.0|-3.93|2.69||||||Non-inferiority (Group 1 - Group 2); Anti-PT. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||2.69|-3.93|
70950331|NCT01411241|141401899|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|-0.36|||||TWO_SIDED|95.0|-4.87|4.06||||||Non-inferiority (Group 1 - Group 2); Anti-FHA. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||4.06|-4.87|
70950332|NCT00725270|141401909|SUPERIORITY_OR_OTHER|||||||0.812|||||||Mixed Models Analysis|||Repeated Measures ANOVA was run on the Positive Symptom Scale of the Brief Psychiatric Rating Scale, using Baseline and Day 9 ratings. Below is the medication \* time interaction.||||.812
70867608|NCT03758066|141221182|OTHER|||||||0.03||||||P-value reported for quality of life measured between baseline and 12-month follow-up with a statistical significance threshold of .05.|Sign test|||A two-tailed non-parametric one-sample paired sign test was used to determine whether to reject or fail to reject the null hypothesis that the mean difference of scores between any of the 2 of 3 timepoints is 0 (Baseline v. 6-month, 6-month v. 12-month, and Baseline v. 12-month).||||.03
70950333|NCT00725270|141401910|SUPERIORITY_OR_OTHER||eta sq|0.157||||0.203|TWO_SIDED||||||Mixed Models Analysis|||||||.203
70950334|NCT02980042|141401911|SUPERIORITY||Risk Ratio (RR)|0.6616||||0.1996|TWO_SIDED|95.0|0.3666|1.1942|||Generalized estimating equations|GEE was necessary because there are repeated measures on subjects.|This is comparing the Switching group to the Comparator group|||1.1942|.3666|0.1996
70950335|NCT02980042|141401912|SUPERIORITY||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|0.5299|1.8872|||Generalized estimating equations|GEE was used because there are repeated measures on subjects|Comparing Switching group Day 1 to combined Comparator group|||1.8872|.5299|1.0000
70950336|NCT02980042|141401912|SUPERIORITY||Risk Ratio (RR)|0.2857||||0.0053|TWO_SIDED|95.0|0.1006|0.8114|||Generalized estimating equations|GEE was used because there are repeated measures on subjects.|Switching group Day 15 was compared to combined Comparator group.|||.8114|.1006|0.0053
70950337|NCT02980042|141401912|SUPERIORITY||Risk Ratio (RR)|0.8571||||0.6474|TWO_SIDED|95.0|0.4385|1.6753|||Generalized estimating equations|GEE was used because there are repeated measures on subjects.||||1.6753|.4385|0.6474
70950338|NCT02980042|141401916|SUPERIORITY||Risk Ratio (RR)|0.2857||||0.0075|TWO_SIDED|95.0|0.1072|0.7613|||Generalized estimating equations|GEE was used because there are repeated measures on subjects.||||.7613|.1072|0.0075
70950339|NCT02980042|141401916|SUPERIORITY||Risk Ratio (RR)|0.8571||||0.593|TWO_SIDED|95.0|0.4868|1.5093|||Generalized estimating equations|GEE was used because there are repeated measures on subjects.||||1.5093|.4868|0.5930
70950340|NCT02980042|141401916|SUPERIORITY||Risk Ratio (RR)|3.0||||0.0209|TWO_SIDED|95.0|1.126|7.9932|||Generalized estimating equations|GEE was used because there are repeated measures on subjects.||||7.9932|1.1260|0.0209
70950341|NCT02980042|141401921|OTHER||Mean Difference (Net)|0.0||||0.005|TWO_SIDED|95.0|-27.05|-5.01||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-5.01|-27.05|0.005
70950342|NCT02980042|141401922|OTHER||Mean Difference (Net)|2.55|||<|0.0001|TWO_SIDED|95.0|1.54|3.56||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||3.56|1.54|<0.0001
70950343|NCT02980042|141401923|OTHER||Median Difference (Net)|8.58|||<|0.0001|TWO_SIDED|95.0|6.33|10.82||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||10.82|6.33|<0.0001
70950344|NCT02980042|141401924|OTHER||Mean Difference (Net)|-7.37|||<|0.0001|TWO_SIDED|95.0|-10.19|-4.55||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-4.55|-10.19|<0.0001
70950345|NCT02980042|141401925|OTHER||Mean Difference (Net)|44.32|||<|0.0001|TWO_SIDED|95.0|29.59|59.05||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||59.05|29.59|<0.0001
70950346|NCT02980042|141401926|OTHER||Mean Difference (Net)|353.35||||0.0002|TWO_SIDED|95.0|175.23|531.46||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||531.46|175.23|0.0002
71142008|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.55||||0.1535|TWO_SIDED|95.0|0.71|9.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.22|0.71|0.1535
70867609|NCT03758066|141221183|SUPERIORITY|||||||0.02||||||P-value reported for self-reported self-efficacy in chronic disease management between baseline and 12-month follow-up with a statistical significance threshold of .05.|Sign test|||A two-tailed non-parametric one-sample paired sign test was used to determine whether to reject or fail to reject the null hypothesis that the mean difference of scores between any of the 2 of 3 timepoints is 0 (Baseline v. 6-month, 6-month v. 12-month, and Baseline v. 12-month).||||.02
70867610|NCT03758066|141221183|OTHER|||||||0.02||||||P-value reported for self-reported self-efficacy in chronic disease management between 6- and 12-month follow-up with a statistical significance threshold of .05.|Sign test|||||||.02
70867611|NCT04138810|141221186|NON_INFERIORITY|We defined the non-inferiority margin to be 5 points which with a sample of size of 25 women per arm would mean we would have a type I error rate of 0.05 and a power of 0.80.|Mean Difference (Net)|0.46|||||TWO_SIDED|95.0|-1.95|1.03||||||||1.03|-1.95|
70950347|NCT02980042|141401927|OTHER||Mean Difference (Net)|176.9|||<|0.0001|TWO_SIDED|95.0|124.5|229.31||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||229.31|124.50|<0.0001
70950348|NCT02980042|141401928|OTHER||Mean Difference (Net)|0.19||||0.002|TWO_SIDED|95.0|0.07|0.32||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||0.32|0.07|0.0020
71142009|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|7.19||||0.0055|TWO_SIDED|95.0|1.79|28.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||28.95|1.79|0.0055
70867612|NCT01786668|141221187|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.8|||||TWO_SIDED|95.0|5.0|30.3|||Emax Model|||Emax model - 95% Confidence Interval represents 95% Credible Interval||30.3|5.0|
70867613|NCT01786668|141221187|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.9|||||TWO_SIDED|95.0|8.4|37.7|||Emax Model|||Emax model - 95% Confidence Interval represents 95% Credible Interval||37.7|8.4|
70867614|NCT01786668|141221187|SUPERIORITY_OR_OTHER||Risk Difference (RD)|27.3|||||TWO_SIDED|95.0|10.7|43.4|||Emax Model|||Emax model - 95% Confidence Interval represents 95% Credible Interval||43.4|10.7|
70867615|NCT01786668|141221188|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.75|STANDARD_ERROR_OF_MEAN|9.77||0.271|TWO_SIDED|95.0|-8.41|29.9|||Normal approximation for two proportions|||||29.90|-8.41|0.271
70867616|NCT01786668|141221188|SUPERIORITY_OR_OTHER||Risk Difference (RD)|39.59|STANDARD_ERROR_OF_MEAN|8.8|<|0.001|TWO_SIDED|95.0|22.35|56.83|||Normal approximation for two proportions|||||56.83|22.35|<0.001
70867617|NCT01786668|141221188|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.59|STANDARD_ERROR_OF_MEAN|9.74||0.134|TWO_SIDED|95.0|-4.5|33.69|||Normal approximation for two proportions|||||33.69|-4.50|0.134
70867618|NCT01786668|141221189|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.93|STANDARD_ERROR_OF_MEAN|9.24||0.162|TWO_SIDED|95.0|-5.17|31.04|||Normal approximation for two proportions|||Week 2||31.04|-5.17|0.162
70867619|NCT01786668|141221189|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.24|STANDARD_ERROR_OF_MEAN|9.02||0.561|TWO_SIDED|95.0|-12.44|22.92|||Normal approximation for two proportions|||Week 2||22.92|-12.44|0.561
70950349|NCT02980042|141401929|OTHER||Mean Difference (Net)|0.55|||<|0.0001|TWO_SIDED|95.0|0.32|0.77||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||0.77|0.32|<0.0001
71142010|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.19||||0.2116|TWO_SIDED|95.0|0.64|7.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.50|0.64|0.2116
70867620|NCT01786668|141221189|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.16|STANDARD_ERROR_OF_MEAN|9.09||0.43|TWO_SIDED|95.0|-10.65|24.97|||Normal approximation for two proportions|||Week 2||24.97|-10.65|0.430
70867621|NCT01786668|141221189|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.74|STANDARD_ERROR_OF_MEAN|9.57||0.123|TWO_SIDED|95.0|-4.01|33.5|||Normal approximation for two proportions|||Week 4||33.50|-4.01|0.123
70867622|NCT01786668|141221189|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.44|STANDARD_ERROR_OF_MEAN|9.54||0.019|TWO_SIDED|95.0|3.74|41.13|||Normal approximation for two proportions|||Week 4||41.13|3.74|0.019
70867623|NCT01786668|141221189|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.74|STANDARD_ERROR_OF_MEAN|9.57||0.123|TWO_SIDED|95.0|-4.01|33.5|||Normal approximation for two proportions|||Week 4||33.50|-4.01|0.123
70867624|NCT01786668|141221189|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.56|STANDARD_ERROR_OF_MEAN|9.75||0.135|TWO_SIDED|95.0|-4.55|33.66|||Normal approximation for two proportions|||Week 8||33.66|-4.55|0.135
70867625|NCT01786668|141221189|SUPERIORITY_OR_OTHER||Risk Difference (RD)|28.02|STANDARD_ERROR_OF_MEAN|9.36||0.003|TWO_SIDED|95.0|9.68|46.36|||Normal approximation for two proportions|||Week 8||46.36|9.68|0.003
70867626|NCT01786668|141221189|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.71|STANDARD_ERROR_OF_MEAN|9.79||0.274|TWO_SIDED|95.0|-8.48|29.9|||Normal approximation for two proportions|||Week 8||29.90|-8.48|0.274
70867627|NCT01786668|141221190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|STANDARD_ERROR_OF_MEAN|1.123||0.427|TWO_SIDED|95.0|-3.11|1.32|||ANCOVA|||||1.32|-3.11|0.427
70867628|NCT01786668|141221190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35|STANDARD_ERROR_OF_MEAN|1.13||0.039|TWO_SIDED|95.0|-4.58|-0.12|||ANCOVA|||||-0.12|-4.58|0.039
70867629|NCT01786668|141221190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.74|STANDARD_ERROR_OF_MEAN|1.131||0.016|TWO_SIDED|95.0|-4.97|-0.51|||ANCOVA|||||-0.51|-4.97|0.016
70867630|NCT01786668|141221191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|1.517||0.05|TWO_SIDED|95.0|-5.99|0.0|||ANCOVA|||||-0.00|-5.99|0.050
70867631|NCT01786668|141221191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.42|STANDARD_ERROR_OF_MEAN|1.52|<|0.001|TWO_SIDED|95.0|-8.42|-2.42|||ANCOVA|||||-2.42|-8.42|<0.001
70867632|NCT01786668|141221191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.47|STANDARD_ERROR_OF_MEAN|1.525|<|0.001|TWO_SIDED|95.0|-9.48|-3.46|||ANCOVA|||||-3.46|-9.48|<0.001
70867633|NCT01786668|141221192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.52||0.221|TWO_SIDED|95.0|-1.66|0.39|||ANCOVA|||||0.39|-1.66|0.221
70867634|NCT01786668|141221192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|-2.83|-0.78|||ANCOVA|||||-0.78|-2.83|<0.001
70867635|NCT01786668|141221192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71|STANDARD_ERROR_OF_MEAN|0.523||0.001|TWO_SIDED|95.0|-2.75|-0.68|||ANCOVA|||||-0.68|-2.75|0.001
70867636|NCT01786668|141221193|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.22|STANDARD_ERROR_OF_MEAN|6.95||0.749|TWO_SIDED|95.0|-15.85|11.4|||Normal approximation for two proportions|||Week 2||11.40|-15.85|0.749
70867637|NCT01786668|141221193|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.22|STANDARD_ERROR_OF_MEAN|6.95||0.749|TWO_SIDED|95.0|-15.85|11.4|||Normal approximation for two proportions|||Week 2||11.40|-15.85|0.749
70867638|NCT01786668|141221193|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.62|STANDARD_ERROR_OF_MEAN|7.31||0.824|TWO_SIDED|95.0|-12.71|15.95|||Normal approximation for two proportions|||Week 2||15.95|-12.71|0.824
70867639|NCT01786668|141221193|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.16|STANDARD_ERROR_OF_MEAN|8.09||0.104|TWO_SIDED|95.0|-2.69|29.01|||Normal approximation for two proportions|||Week 4||29.01|-2.69|0.104
70867640|NCT01786668|141221193|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.01|STANDARD_ERROR_OF_MEAN|8.26||0.04|TWO_SIDED|95.0|0.81|33.2|||Normal approximation for two proportions|||Week 4||33.20|0.81|0.040
70950350|NCT02980042|141401930|OTHER||Mean Difference (Net)|-46.16||||0.0091|TWO_SIDED|95.0|-80.61|-11.72||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-11.72|-80.61|0.0091
70950351|NCT02980042|141401931|OTHER||Mean Difference (Net)|55.26||||0.0002|TWO_SIDED|95.0|27.0|83.52||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||83.52|27.00|0.0002
70950352|NCT02980042|141401932|OTHER||Mean Difference (Net)|-17.24||||0.0044|TWO_SIDED|95.0|-28.96|-5.51||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-5.51|-28.96|0.0044
70950353|NCT02980042|141401933|OTHER||Mean Difference (Net)|16.01|||<|0.0001|TWO_SIDED|95.0|9.75|22.28||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||22.28|9.75|<0.0001
70950354|NCT02980042|141401934|OTHER||Mean Difference (Net)|429.08|||<|0.0001|TWO_SIDED|95.0|296.07|562.1||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||562.10|296.07|<0.0001
70950355|NCT02980042|141401935|OTHER||Mean Difference (Net)|1.23||||0.0101|TWO_SIDED|95.0|0.3|2.16||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||2.16|0.30|0.0101
70950356|NCT02980042|141401936|OTHER||Mean Difference (Net)|8.69|||<|0.0001|TWO_SIDED|95.0|4.87|12.52||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||12.52|4.87|<0.0001
71142011|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.34||||0.1668|TWO_SIDED|95.0|0.7|7.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.83|0.70|0.1668
71142012|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.32||||0.1824|TWO_SIDED|95.0|0.67|7.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||7.98|0.67|0.1824
71142013|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|0.85||||0.797|TWO_SIDED|95.0|0.25|2.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.90|0.25|0.7970
70950357|NCT02980042|141401937|OTHER||Mean Difference (Net)|1.53|||<|0.0001|TWO_SIDED|95.0|1.04|2.03||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||2.03|1.04|<0.0001
70950358|NCT02980042|141401938|OTHER||Mean Difference (Net)|-33.17|||<|0.0001|TWO_SIDED|95.0|-38.91|-27.44||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-27.44|-38.91|<0.0001
70950359|NCT02980042|141401939|OTHER||Mean Difference (Net)|-0.62||||0.0008|TWO_SIDED|95.0|-0.98|-0.26||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-0.26|-0.98|0.0008
70950360|NCT02980042|141401940|OTHER||Mean Difference (Net)|2.01|||<|0.0001|TWO_SIDED|95.0|1.23|2.79||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||2.79|1.23|<0.0001
71142014|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|0.78||||0.7065|TWO_SIDED|95.0|0.21|2.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.85|0.21|0.7065
70950361|NCT02980042|141401941|OTHER||Mean Difference (Net)|-7.84|||<|0.0001|TWO_SIDED|95.0|-9.87|-5.81||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-5.81|-9.87|<0.0001
70950362|NCT02980042|141401942|OTHER||Mean Difference (Net)|-14.2||||0.0022|TWO_SIDED|95.0|-23.15|-5.25||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-5.25|-23.15|0.0022
70950363|NCT02980042|141401943|OTHER||Mean Difference (Net)|0.3|||<|0.0001|TWO_SIDED|95.0|0.17|0.43||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||0.43|0.17|<0.0001
71142015|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9126|TWO_SIDED|95.0|0.29|3.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.93|0.29|0.9126
71142016|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.82||||0.1282|TWO_SIDED|95.0|0.74|10.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||10.70|0.74|0.1282
71142017|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.03||||0.2661|TWO_SIDED|95.0|0.58|7.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||7.04|0.58|0.2661
71142018|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|1.22||||0.7457|TWO_SIDED|95.0|0.36|4.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.09|0.36|0.7457
71142019|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|1.73||||0.4095|TWO_SIDED|95.0|0.47|6.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||6.41|0.47|0.4095
71142020|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|1.04||||0.9571|TWO_SIDED|95.0|0.28|3.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.77|0.28|0.9571
71142021|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8827|TWO_SIDED|95.0|0.23|3.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.59|0.23|0.8827
71142022|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|0.69||||0.5944|TWO_SIDED|95.0|0.17|2.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.74|0.17|0.5944
71142023|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.74||||0.1647|TWO_SIDED|95.0|0.66|11.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||11.39|0.66|0.1647
71142024|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|2.07||||0.2684|TWO_SIDED|95.0|0.57|7.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||7.48|0.57|0.2684
71142025|NCT03192176|141778540|SUPERIORITY||Odds Ratio (OR)|1.48||||0.5338|TWO_SIDED|95.0|0.43|5.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.07|0.43|0.5338
71142026|NCT03192176|141778541|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.45||0.0179|TWO_SIDED|95.0|-1.95|-0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|Mixed model repeated measures (MMRM)|||Week 4||-0.18|-1.95|0.0179
71142027|NCT03192176|141778541|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.45||0.0027|TWO_SIDED|95.0|-2.25|-0.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.47|-2.25|0.0027
71142028|NCT03192176|141778541|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.45||0.0004|TWO_SIDED|95.0|-2.5|-0.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.73|-2.50|0.0004
71142029|NCT03192176|141778541|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.46||0.0009|TWO_SIDED|95.0|-2.43|-0.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.64|-2.43|0.0009
71142030|NCT03192176|141778541|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.45||0.5806|TWO_SIDED|95.0|-1.14|0.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||0.64|-1.14|0.5806
70867641|NCT01786668|141221193|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.47|STANDARD_ERROR_OF_MEAN|7.62||0.473|TWO_SIDED|95.0|-9.46|20.4|||Normal approximation for two proportions|||Week 4||20.40|-9.46|0.473
70867642|NCT01786668|141221193|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.4|STANDARD_ERROR_OF_MEAN|8.86||0.875|TWO_SIDED|95.0|-15.97|18.76|||Normal approximation for two proportions|||Week 8||18.76|-15.97|0.875
71142031|NCT03192176|141778541|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.45||0.0105|TWO_SIDED|95.0|-2.03|-0.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.27|-2.03|0.0105
71142032|NCT03192176|141778541|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.45||0.0048|TWO_SIDED|95.0|-2.16|-0.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.39|-2.16|0.0048
71142033|NCT03192176|141778541|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.46||0.1801|TWO_SIDED|95.0|-1.52|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.29|-1.52|0.1801
71142034|NCT03192176|141778541|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.46||0.0609|TWO_SIDED|95.0|-1.76|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.04|-1.76|0.0609
71142035|NCT03192176|141778541|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.47||0.0028|TWO_SIDED|95.0|-2.33|-0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.49|-2.33|0.0028
71142036|NCT03192176|141778541|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.47||0.0018|TWO_SIDED|95.0|-2.4|-0.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.55|-2.40|0.0018
71142037|NCT03192176|141778541|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.46||0.5519|TWO_SIDED|95.0|-1.19|0.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.64|-1.19|0.5519
70950364|NCT02980042|141401944|OTHER||Mean Difference (Net)|0.41|||<|0.0001|TWO_SIDED|95.0|0.22|0.61||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||0.61|0.22|<0.0001
70867643|NCT01786668|141221193|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.16|STANDARD_ERROR_OF_MEAN|9.09||0.43|TWO_SIDED|95.0|-10.65|24.97|||Normal approximation for two proportions|||Week 8||24.97|-10.65|0.430
70867644|NCT01786668|141221193|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.09|STANDARD_ERROR_OF_MEAN|9.15||0.32|TWO_SIDED|95.0|-8.84|27.01|||Normal approximation for two proportions|||Week 8||27.01|-8.84|0.320
70867645|NCT01786668|141221193|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.7|STANDARD_ERROR_OF_MEAN|8.82||0.01|TWO_SIDED|95.0|5.41|39.99|||Normal approximation for two proportions|||Week 12||39.99|5.41|0.010
70867646|NCT01786668|141221193|SUPERIORITY_OR_OTHER||Risk Difference (RD)|26.55|STANDARD_ERROR_OF_MEAN|8.87||0.003|TWO_SIDED|95.0|9.16|43.93|||Normal approximation for two proportions|||Week 12||43.93|9.16|0.003
70867647|NCT01786668|141221193|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.85|STANDARD_ERROR_OF_MEAN|8.74||0.031|TWO_SIDED|95.0|1.72|35.99|||Normal approximation for two proportions|||Week 12||35.99|1.72|0.031
70867648|NCT01786668|141221194|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.23|STANDARD_ERROR_OF_MEAN|6.95||0.028|TWO_SIDED|95.0|1.61|28.86|||Normal approximation for two proportions|||Week 2||28.86|1.61|0.028
70950365|NCT02980042|141401945|OTHER||Mean Difference (Net)|-0.72|||<|0.0001|TWO_SIDED|95.0|-0.95|-0.5||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-0.50|-0.95|<0.0001
70950366|NCT02980042|141401946|OTHER||Mean Difference (Net)|-19.31|||<|0.0001|TWO_SIDED|95.0|-22.64|-15.98||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-15.98|-22.64|<0.0001
70867649|NCT01786668|141221194|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.62|STANDARD_ERROR_OF_MEAN|6.05||0.353|TWO_SIDED|95.0|-6.23|17.47|||Normal approximation for two proportions|||Week 2||17.47|-6.23|0.353
70867650|NCT01786668|141221194|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.31|STANDARD_ERROR_OF_MEAN|6.8||0.05|TWO_SIDED|95.0|-0.02|26.64|||Normal approximation for two proportions|||Week 2||26.64|-0.02|0.050
70867651|NCT01786668|141221194|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.39|STANDARD_ERROR_OF_MEAN|6.64||0.086|TWO_SIDED|95.0|-1.62|24.39|||Normal approximation for two proportions|||Week 4||24.39|-1.62|0.086
70867652|NCT01786668|141221194|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.93|STANDARD_ERROR_OF_MEAN|7.43||0.002|TWO_SIDED|95.0|8.37|37.48|||Normal approximation for two proportions|||Week 4||37.48|8.37|0.002
70867653|NCT01786668|141221194|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.0|STANDARD_ERROR_OF_MEAN|7.32||0.004|TWO_SIDED|95.0|6.65|35.36|||Normal approximation for two proportions|||Week 4||35.36|6.65|0.004
70867654|NCT01786668|141221194|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.35|STANDARD_ERROR_OF_MEAN|7.03||0.106|TWO_SIDED|95.0|-2.43|25.13|||Normal approximation for two proportions|||Week 8||25.13|-2.43|0.106
70867655|NCT01786668|141221194|SUPERIORITY_OR_OTHER||Risk Difference (RD)|32.5|STANDARD_ERROR_OF_MEAN|8.02|<|0.001|TWO_SIDED|95.0|16.79|48.22|||Normal approximation for two proportions|||Week 8||48.22|16.79|<0.001
70867656|NCT01786668|141221194|SUPERIORITY_OR_OTHER||Risk Difference (RD)|19.04|STANDARD_ERROR_OF_MEAN|7.54||0.012|TWO_SIDED|95.0|4.27|33.81|||Normal approximation for two proportions|||Week 8||33.81|4.27|0.012
70867657|NCT01786668|141221194|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.54|STANDARD_ERROR_OF_MEAN|7.47||0.635|TWO_SIDED|95.0|-11.1|18.19|||Normal approximation for two proportions|||Week 12||18.19|-11.10|0.635
70867658|NCT01786668|141221194|SUPERIORITY_OR_OTHER||Risk Difference (RD)|34.31|STANDARD_ERROR_OF_MEAN|8.6|<|0.001|TWO_SIDED|95.0|17.45|51.18|||Normal approximation for two proportions|||Week 12||51.18|17.45|<0.001
70867659|NCT01786668|141221194|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.78|STANDARD_ERROR_OF_MEAN|8.45||0.007|TWO_SIDED|95.0|6.21|39.34|||Normal approximation for two proportions|||Week 12||39.34|6.21|0.007
70867660|NCT01786668|141221195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.136||0.175|TWO_SIDED|95.0|-0.46|0.08|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.08|-0.46|0.175
70867661|NCT01786668|141221195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.136|<|0.001|TWO_SIDED|95.0|-0.77|-0.24|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||-0.24|-0.77|<0.001
70867662|NCT01786668|141221195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.136|<|0.001|TWO_SIDED|95.0|-0.74|-0.2|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||-0.20|-0.74|<0.001
70867663|NCT01786668|141221195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.141||0.003|TWO_SIDED|95.0|-0.7|-0.15|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||-0.15|-0.70|0.003
70867664|NCT01786668|141221195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.141|<|0.001|TWO_SIDED|95.0|-0.9|-0.34|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||-0.34|-0.90|<0.001
70867665|NCT01786668|141221195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.141|<|0.001|TWO_SIDED|95.0|-0.86|-0.31|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||-0.31|-0.86|<0.001
70950367|NCT02980042|141401947|OTHER||Mean Difference (Net)|-6.96|||<|0.0001|TWO_SIDED|95.0|-9.85|-4.08||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-4.08|-9.85|<0.0001
70950368|NCT02980042|141401948|OTHER||Mean Difference (Net)|-23.22||||0.0061|TWO_SIDED|95.0|-39.66|-6.78||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-6.78|-39.66|0.0061
70950369|NCT02980042|141401949|OTHER||Mean Difference (Net)|-5.69|||<|0.0001|TWO_SIDED|95.0|-7.24|-4.14||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-4.14|-7.24|<0.0001
70950370|NCT02980042|141401950|OTHER||Mean Difference (Net)|-0.84||||0.0077|TWO_SIDED|95.0|-1.45|-0.23||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-0.23|-1.45|0.0077
71142038|NCT03192176|141778541|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.46||0.1922|TWO_SIDED|95.0|-1.51|0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.31|-1.51|0.1922
70950371|NCT02980042|141401951|OTHER||Mean Difference (Net)|-0.32|||<|0.0001|TWO_SIDED|95.0|-0.37|-0.27||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-0.27|-0.37|<0.0001
71142039|NCT03192176|141778541|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.46||0.0463|TWO_SIDED|95.0|-1.82|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.02|-1.82|0.0463
71142040|NCT03192176|141778541|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.44||0.1288|TWO_SIDED|95.0|-1.53|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.19|-1.53|0.1288
70950372|NCT01483144|141401960|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.121|TWO_SIDED|95.0|0.4|1.3||The threshold for statistical significance is p=0.05|stratified Cox proportional (Score)||Eflornithine plus sulindac is the numerator and sulindac plus eflornithine placebo is the denominator.|Intent to treat population with all FAP-related events||1.3|0.4|0.1210
70950373|NCT01483144|141401960|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.1076|TWO_SIDED|95.0|0.4|1.2||The threshold for statistical significance is p=0.05|stratified Cox proportional (Score)||Eflornithine plus sulindac is the numerator and eflornithine plus sulindac placebo is the denominator.|Intent to treat population with all FAP-related events||1.2|0.4|0.1076
71142041|NCT03192176|141778541|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.44||0.0577|TWO_SIDED|95.0|-1.72|0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.03|-1.72|0.0577
71142042|NCT03192176|141778541|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.45||0.0027|TWO_SIDED|95.0|-2.26|-0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.48|-2.26|0.0027
71142043|NCT03192176|141778541|SUPERIORITY||-1.3|-1.3|STANDARD_ERROR_OF_MEAN|0.45||0.0043|TWO_SIDED|95.0|-2.2|-0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.41|-2.20|0.0043
71142044|NCT03192176|141778541|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.45||0.4089|TWO_SIDED|95.0|-1.27|0.52||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.52|-1.27|0.4089
71142045|NCT03192176|141778541|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.44||0.205|TWO_SIDED|95.0|-1.44|0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.31|-1.44|0.2050
70950374|NCT01483144|141401960|SUPERIORITY||Hazard Ratio (HR)|0.2||||0.0201|TWO_SIDED|95.0|0.0|0.8||Threshold for statistical significance was p=0.05|stratified Cox proportional (Score)||Eflornithine and sulindac is the numerator and sulindac and eflornithine placebo is the denominator. Reduction in relative risk for FAP-related events with the combination.|Lower GI population||0.8|0.0|0.0201
70867666|NCT01786668|141221195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.158||0.026|TWO_SIDED|95.0|-0.66|-0.04|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||-0.04|-0.66|0.026
70950375|NCT01483144|141401960|SUPERIORITY||Hazard Ratio (HR)|0.17||||0.0101|TWO_SIDED|95.0|0.0|0.7||Threshold of significance was p=0.05|stratified Cox proportional (Score)||Eflornithine and sulindac is the numerator and eflornithine and sulindac placebo is the denominator.|Lower GI population||0.7|0|0.0101
70950376|NCT01483144|141401961|SUPERIORITY|||||||0.8127||||||The threshold of significance was p=0.05|Mantel Haenszel|||||||0.8127
70950377|NCT01483144|141401961|SUPERIORITY|||||||0.8133||||||The threshold for significance was p=0.05|Mantel Haenszel|||||||0.8133
70867667|NCT01786668|141221195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.157|<|0.001|TWO_SIDED|95.0|-0.94|-0.32|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||-0.32|-0.94|<0.001
70867668|NCT01786668|141221195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.159|<|0.001|TWO_SIDED|95.0|-0.9|-0.27|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||-0.27|-0.90|<0.001
70867669|NCT01786668|141221195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.171||0.002|TWO_SIDED|95.0|-0.89|-0.21|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.21|-0.89|0.002
70867670|NCT01786668|141221195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.171|<|0.001|TWO_SIDED|95.0|-1.07|-0.39|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.39|-1.07|<0.001
70867671|NCT01786668|141221195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.172|<|0.001|TWO_SIDED|95.0|-1.03|-0.35|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.35|-1.03|<0.001
70867672|NCT01786668|141221196|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.24|STANDARD_ERROR_OF_MEAN|7.99||0.159|TWO_SIDED|95.0|-4.41|26.89|||Normal approximation for two proportions|||Week 2||26.89|-4.41|0.159
70867673|NCT01786668|141221196|SUPERIORITY_OR_OTHER||Risk Difference (RD)|32.39|STANDARD_ERROR_OF_MEAN|8.6|<|0.001|TWO_SIDED|95.0|15.54|49.24|||Normal approximation for two proportions|||Week 2||49.24|15.54|<0.001
70867674|NCT01786668|141221196|SUPERIORITY_OR_OTHER||Risk Difference (RD)|24.7|STANDARD_ERROR_OF_MEAN|8.5||0.004|TWO_SIDED|95.0|8.04|41.36|||Normal approximation for two proportions|||Week 2||41.36|8.04|0.004
70867675|NCT01786668|141221196|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.7|STANDARD_ERROR_OF_MEAN|8.82||0.01|TWO_SIDED|95.0|5.41|39.99|||Normal approximation for two proportions|||Week 4||39.99|5.41|0.010
70867676|NCT01786668|141221196|SUPERIORITY_OR_OTHER||Risk Difference (RD)|38.08|STANDARD_ERROR_OF_MEAN|8.82|<|0.001|TWO_SIDED|95.0|20.79|55.38|||Normal approximation for two proportions|||Week 4||55.38|20.79|<0.001
70867677|NCT01786668|141221196|SUPERIORITY_OR_OTHER||Risk Difference (RD)|32.32|STANDARD_ERROR_OF_MEAN|8.88|<|0.001|TWO_SIDED|95.0|14.9|49.73|||Normal approximation for two proportions|||Week 4||49.73|14.90|<0.001
70867678|NCT01786668|141221196|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.82|STANDARD_ERROR_OF_MEAN|9.39||0.114|TWO_SIDED|95.0|-3.58|33.22|||Normal approximation for two proportions|||Week 8||33.22|-3.58|0.114
70867679|NCT01786668|141221196|SUPERIORITY_OR_OTHER||Risk Difference (RD)|30.2|STANDARD_ERROR_OF_MEAN|9.33||0.001|TWO_SIDED|95.0|11.92|48.49|||Normal approximation for two proportions|||Week 8||48.49|11.92|0.001
70867680|NCT01786668|141221196|SUPERIORITY_OR_OTHER||Risk Difference (RD)|30.2|STANDARD_ERROR_OF_MEAN|9.33||0.001|TWO_SIDED|95.0|11.92|48.49|||Normal approximation for two proportions|||Week 8||48.49|11.92|0.001
70867681|NCT01786668|141221196|SUPERIORITY_OR_OTHER||Risk Difference (RD)|24.47|STANDARD_ERROR_OF_MEAN|9.33||0.009|TWO_SIDED|95.0|6.18|42.76|||Normal approximation for two proportions|||Week 12||42.76|6.18|0.009
70867682|NCT01786668|141221196|SUPERIORITY_OR_OTHER||Risk Difference (RD)|36.01|STANDARD_ERROR_OF_MEAN|9.15|<|0.001|TWO_SIDED|95.0|18.09|53.94|||Normal approximation for two proportions|||Week 12||53.94|18.09|<0.001
70867683|NCT01786668|141221196|SUPERIORITY_OR_OTHER||Risk Difference (RD)|28.32|STANDARD_ERROR_OF_MEAN|9.3||0.002|TWO_SIDED|95.0|10.09|46.55|||Normal approximation for two proportions|||Week 12||46.55|10.09|0.002
70867684|NCT01786668|141221197|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.73|STANDARD_ERROR_OF_MEAN|4.17||0.17|TWO_SIDED|95.0|-2.45|13.91|||Normal approximation for two proportions|||Week 2||13.91|-2.45|0.170
71142046|NCT03192176|141778541|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.44||0.0265|TWO_SIDED|95.0|-1.84|-0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.11|-1.84|0.0265
70867685|NCT01786668|141221197|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.73|STANDARD_ERROR_OF_MEAN|4.17||0.17|TWO_SIDED|95.0|-2.45|13.91|||Normal approximation for two proportions|||Week 2||13.91|-2.45|0.170
70867686|NCT01786668|141221197|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.73|STANDARD_ERROR_OF_MEAN|4.17||0.17|TWO_SIDED|95.0|-2.45|13.91|||Normal approximation for two proportions|||Week 2||13.91|-2.45|0.170
70867687|NCT01786668|141221197|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.66|STANDARD_ERROR_OF_MEAN|5.52||0.306|TWO_SIDED|95.0|-5.17|16.48|||Normal approximation for two proportions|||Week 4||16.48|-5.17|0.306
70867688|NCT01786668|141221197|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.66|STANDARD_ERROR_OF_MEAN|5.52||0.306|TWO_SIDED|95.0|-5.17|16.48|||Normal approximation for two proportions|||Week 4||16.48|-5.17|0.306
70867689|NCT01786668|141221197|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.5|STANDARD_ERROR_OF_MEAN|5.99||0.113|TWO_SIDED|95.0|-2.24|21.24|||Normal approximation for two proportions|||Week 4||21.24|-2.24|0.113
70867690|NCT01786668|141221197|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.73|STANDARD_ERROR_OF_MEAN|6.08||0.775|TWO_SIDED|95.0|-10.18|13.65|||Normal approximation for two proportions|||Week 8||13.65|-10.18|0.775
70867691|NCT01786668|141221197|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.12|STANDARD_ERROR_OF_MEAN|7.43||0.021|TWO_SIDED|95.0|2.56|31.68|||Normal approximation for two proportions|||Week 8||31.68|2.56|0.021
70867692|NCT01786668|141221197|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.27|STANDARD_ERROR_OF_MEAN|7.17||0.064|TWO_SIDED|95.0|-0.79|27.34|||Normal approximation for two proportions|||Week 8||27.34|-0.79|0.064
70867693|NCT01786668|141221197|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.47|STANDARD_ERROR_OF_MEAN|7.09||0.292|TWO_SIDED|95.0|-6.42|21.36|||Normal approximation for two proportions|||Week 12||21.36|-6.42|0.292
70950378|NCT01483144|141401962|SUPERIORITY|||||||0.999||||||The threshold for significance was p=0.05|Mantel Haenszel|||||||0.999
70950379|NCT01483144|141401962|SUPERIORITY|||||||0.2152||||||The threshold for significance was p=0.05|Mantel Haenszel|||||||0.2152
70950380|NCT01189110|141401999|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81|STANDARD_ERROR_OF_MEAN|0.42||0.74|TWO_SIDED|95.0|0.23|2.83|||Chi-squared|||A two-proportion z-test was used to compare the proportion of self-reported abstinence at 3 weeks between groups.||2.83|0.23|0.74
70867694|NCT01786668|141221197|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.31|STANDARD_ERROR_OF_MEAN|7.38||0.125|TWO_SIDED|95.0|-3.16|25.78|||Normal approximation for two proportions|||Week 12||25.78|-3.16|0.125
70867695|NCT01786668|141221197|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.24|STANDARD_ERROR_OF_MEAN|7.51||0.078|TWO_SIDED|95.0|-1.49|27.96|||Normal approximation for two proportions|||Week 12||27.96|-1.49|0.078
70867696|NCT01786668|141221198|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.92|STANDARD_ERROR_OF_MEAN|1.9||0.313|TWO_SIDED|95.0|-1.81|5.66|||Normal approximation for two proportions|||Week 2||5.66|-1.81|0.313
71142047|NCT03192176|141778541|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.53||0.7617|TWO_SIDED|95.0|-1.2|0.88||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.88|-1.20|0.7617
71142048|NCT03192176|141778541|SUPERIORITY||LSMean difference|0.3|STANDARD_ERROR_OF_MEAN|0.53||0.6061|TWO_SIDED|95.0|-0.77|1.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.32|-0.77|0.6061
71142049|NCT03192176|141778541|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.54||0.7997|TWO_SIDED|95.0|-0.93|1.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.21|-0.93|0.7997
71142050|NCT03192176|141778541|SUPERIORITY||LSMean difference|0.5|STANDARD_ERROR_OF_MEAN|0.55||0.3391|TWO_SIDED|95.0|-0.55|1.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.60|-0.55|0.3391
71142051|NCT03192176|141778541|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.55||0.3934|TWO_SIDED|95.0|-1.55|0.61||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.61|-1.55|0.3934
71142052|NCT03192176|141778541|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.54||0.975|TWO_SIDED|95.0|-1.08|1.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.04|-1.08|0.9750
71142053|NCT03192176|141778541|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.53||0.883|TWO_SIDED|95.0|-1.13|0.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.97|-1.13|0.8830
71142054|NCT03192176|141778542|SUPERIORITY||LSMean difference|2.3|STANDARD_ERROR_OF_MEAN|4.27||0.5872|TWO_SIDED|95.0|-6.09|10.73||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||10.73|-6.09|0.5872
71142055|NCT03192176|141778542|SUPERIORITY||LSMean difference|3.8|STANDARD_ERROR_OF_MEAN|4.33||0.3779|TWO_SIDED|95.0|-4.7|12.35||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||12.35|-4.70|0.3779
71142056|NCT03192176|141778542|SUPERIORITY||LSMean difference|-4.1|STANDARD_ERROR_OF_MEAN|4.34||0.3506|TWO_SIDED|95.0|-12.61|4.49||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||4.49|-12.61|0.3506
71142057|NCT03192176|141778542|SUPERIORITY||LSMean difference|1.0|STANDARD_ERROR_OF_MEAN|4.39||0.8236|TWO_SIDED|95.0|-7.66|9.62||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||9.62|-7.66|0.8236
70950381|NCT01732549|141402002|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.0315||||||Log-rank test adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). Two-sided p-value.|Log Rank|||Stratified\[a\]||||=0.0315
70950382|NCT01732549|141402002|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.0344|||||||Log Rank|||Unstratified\[b\]||||=0.0344
70950383|NCT01732549|141402003|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.443|||||||Log Rank|Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value||Stratified\[a\]||||=0.4430
70867697|NCT01786668|141221198|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.92|STANDARD_ERROR_OF_MEAN|1.9||0.313|TWO_SIDED|95.0|-1.81|5.66|||Normal approximation for two proportions|||Week 2||5.66|-1.81|0.313
70950384|NCT01732549|141402004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5219|||||||Log Rank|Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value||Stratified\[a\]||||0.5219
70950385|NCT01732549|141402005|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.5442|||||||Log Rank|Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value||Stratified\[a\]||||=0.5442
70950386|NCT01732549|141402006|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.112|||||||Log Rank|Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value||Stratified\[a\]||||=0.1120
70950387|NCT01732549|141402007|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.2491|||||||Log Rank|Adjusting for presence (or absence) of visceral metastases, opioid analgesic use (or not) \& region (Eastern Europe, Western Europe). One-sided p-value||Stratified\[a\]||||=0.2491
70950388|NCT01516749|141402010|SUPERIORITY_OR_OTHER|||||||0.024||||||significance was accepted at p\<0.05|t-test, 2 sided|||Significance of decrease in modified Sartorius score from Baseline to 8 weeks||||0.024
70950389|NCT01516749|141402011|SUPERIORITY_OR_OTHER|||||||0.006||||||Significance was accepted at p\<0.05|t-test, 2 sided|||Significance of reductions in Physican Global Assessment mean values between baseline and 8 weeks of therapy||||0.006
70950390|NCT01516749|141402011|SUPERIORITY_OR_OTHER|||||||0.019||||||Significance was accepted at p\<0.05|t-test, 2 sided|||Significance of reductions in Patient Global Assessment mean values between baseline and 8 weeks of therapy||||0.019
71142058|NCT03192176|141778542|SUPERIORITY||LSMean difference|2.3|STANDARD_ERROR_OF_MEAN|4.35||0.5949|TWO_SIDED|95.0|-6.24|10.87||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||10.87|-6.24|0.5949
71142059|NCT03192176|141778542|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|4.19||0.9237|TWO_SIDED|95.0|-8.65|7.85||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||7.85|-8.65|0.9237
71142060|NCT03192176|141778542|SUPERIORITY||LSMean difference|4.0|STANDARD_ERROR_OF_MEAN|4.32||0.3599|TWO_SIDED|95.0|-4.54|12.46||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||12.46|-4.54|0.3599
71142061|NCT03192176|141778542|SUPERIORITY||LSMean difference|1.7|STANDARD_ERROR_OF_MEAN|5.08||0.7422|TWO_SIDED|95.0|-8.33|11.68||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||11.68|-8.33|0.7422
71142062|NCT03192176|141778542|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|5.09||0.603|TWO_SIDED|95.0|-12.67|7.37||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||7.37|-12.67|0.6030
71142063|NCT03192176|141778542|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|5.14||0.2478|TWO_SIDED|95.0|-16.07|4.17||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||4.17|-16.07|0.2478
71142064|NCT03192176|141778542|SUPERIORITY||LSMean difference|3.3|STANDARD_ERROR_OF_MEAN|5.18||0.5295|TWO_SIDED|95.0|-6.94|13.47||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||13.47|-6.94|0.5295
71142065|NCT03192176|141778542|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|5.16||0.6938|TWO_SIDED|95.0|-12.2|8.13||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||8.13|-12.20|0.6938
71142066|NCT03192176|141778542|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|4.97||0.9765|TWO_SIDED|95.0|-9.93|9.63||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||9.63|-9.93|0.9765
71142067|NCT03192176|141778542|SUPERIORITY||LSMean difference|3.7|STANDARD_ERROR_OF_MEAN|5.13||0.4771|TWO_SIDED|95.0|-6.45|13.76||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||13.76|-6.45|0.4771
71142068|NCT03192176|141778542|SUPERIORITY||LSMean difference|3.5|STANDARD_ERROR_OF_MEAN|4.44||0.4256|TWO_SIDED|95.0|-5.19|12.27||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||12.27|-5.19|0.4256
70950391|NCT00584077|141402023|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||ANOVA|||Each subject served as their own control as a comparison of the airway innervated (contralateral native lung) with the denervated airway (allograft)||||<0.01
70950392|NCT00584077|141402024|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value was adjusted for multiple comparisons using Bonferroni test|ANOVA|||For the cross-sectional and longitudinal groups, a comparison of cough frequency after airway irritation of the main carina, and the proximal and distal anastomotic sites was performed using one-way analysis of variance with Bonferroni test. In the longitudinal cohort, a comparison of the cough frequencies at different airway sites at 1.5 and 12 months was performed using one-way analysis of variance with Bonferroni test.||||<0.01
70867698|NCT01786668|141221198|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.92|STANDARD_ERROR_OF_MEAN|1.9||0.313|TWO_SIDED|95.0|-1.81|5.66|||Normal approximation for two proportions|||Week 2||5.66|-1.81|0.313
70950393|NCT03054337|141402070|SUPERIORITY||Least squares mean difference|0.9|STANDARD_ERROR_OF_MEAN|0.301||0.0045|TWO_SIDED|95.0|0.29|1.51|||ANCOVA|The analysis of covariance (ANCOVA) model included treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||||1.51|0.29|0.0045
70867699|NCT01786668|141221198|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.04|STANDARD_ERROR_OF_MEAN|2.72||0.989|TWO_SIDED|95.0|-5.37|5.29|||Normal approximation for two proportions|||Week 4||5.29|-5.37|0.989
70867700|NCT01786668|141221198|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.81|STANDARD_ERROR_OF_MEAN|3.77||0.313|TWO_SIDED|95.0|-3.58|11.2|||Normal approximation for two proportions|||Week 4||11.20|-3.58|0.313
70867701|NCT01786668|141221198|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.73|STANDARD_ERROR_OF_MEAN|4.17||0.17|TWO_SIDED|95.0|-2.45|13.91|||Normal approximation for two proportions|||Week 4||13.91|-2.45|0.170
70867702|NCT01786668|141221198|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.81|STANDARD_ERROR_OF_MEAN|3.77||0.313|TWO_SIDED|95.0|-3.58|11.2|||Normal approximation for two proportions|||Week 8||11.20|-3.58|0.313
70950394|NCT03054337|141402070|SUPERIORITY||Least squares mean difference|1.59|STANDARD_ERROR_OF_MEAN|0.306|<|0.0001|TWO_SIDED|95.0|0.98|2.21|||ANCOVA|The ANCOVA model included treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||||2.21|0.98|<0.0001
70950395|NCT03054337|141402070|SUPERIORITY||Least squares mean difference|2.09|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|1.49|2.7|||ANCOVA|The ANCOVA model included treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||||2.70|1.49|<0.0001
70950396|NCT03054337|141402076|SUPERIORITY||Least squares mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.103||0.0018|TWO_SIDED|95.0|0.13|0.55|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||RBC Count||0.55|0.13|0.0018
70950397|NCT03054337|141402076|SUPERIORITY||Least squares mean difference|0.51|STANDARD_ERROR_OF_MEAN|0.103|<|0.0001|TWO_SIDED|95.0|0.3|0.72|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||RBC Count||0.72|0.30|<0.0001
70867703|NCT01786668|141221198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|2.72||0.989|TWO_SIDED|95.0|-5.37|5.29|||Normal approximation for two proportions|||Week 8||5.29|-5.37|0.989
70867704|NCT01786668|141221198|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.65|STANDARD_ERROR_OF_MEAN|4.53||0.091|TWO_SIDED|95.0|-1.22|16.52|||Normal approximation for two proportions|||Week 8||16.52|-1.22|0.091
70867705|NCT01786668|141221198|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.62|STANDARD_ERROR_OF_MEAN|6.05||0.353|TWO_SIDED|95.0|-6.23|17.47|||Normal approximation for two proportions|||Week 12||17.47|-6.23|0.353
70867706|NCT01786668|141221198|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.62|STANDARD_ERROR_OF_MEAN|6.05||0.353|TWO_SIDED|95.0|-6.23|17.47|||Normal approximation for two proportions|||Week 12||17.47|-6.23|0.353
70867707|NCT01786668|141221198|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.54|STANDARD_ERROR_OF_MEAN|6.26||0.228|TWO_SIDED|95.0|-4.73|19.81|||Normal approximation for two proportions|||Week 12||19.81|-4.73|0.228
70867708|NCT01786668|141221199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.31||0.926|TWO_SIDED|95.0|-0.64|0.58|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.58|-0.64|0.926
71142069|NCT03192176|141778542|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|4.45||0.9559|TWO_SIDED|95.0|-8.52|9.01||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||9.01|-8.52|0.9559
70867709|NCT01786668|141221199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.308||0.718|TWO_SIDED|95.0|-0.72|0.5|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.50|-0.72|0.718
70867710|NCT01786668|141221199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.31||0.57|TWO_SIDED|95.0|-0.43|0.79|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.79|-0.43|0.570
70867711|NCT01786668|141221199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.343||0.384|TWO_SIDED|95.0|-0.97|0.38|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.38|-0.97|0.384
70867712|NCT01786668|141221199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.341||0.334|TWO_SIDED|95.0|-1.0|0.34|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.34|-1.00|0.334
70867713|NCT01786668|141221199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.343||0.474|TWO_SIDED|95.0|-0.92|0.43|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.43|-0.92|0.474
70867714|NCT01786668|141221199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.381||0.445|TWO_SIDED|95.0|-1.04|0.46|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.46|-1.04|0.445
70867715|NCT01786668|141221199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.38||0.174|TWO_SIDED|95.0|-1.27|0.23|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.23|-1.27|0.174
70867716|NCT01786668|141221199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.383||0.217|TWO_SIDED|95.0|-1.23|0.28|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.28|-1.23|0.217
70867717|NCT01786668|141221199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.396||0.024|TWO_SIDED|95.0|-1.69|-0.12|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.12|-1.69|0.024
70867718|NCT01786668|141221199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|0.396||0.01|TWO_SIDED|95.0|-1.81|-0.24|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.24|-1.81|0.010
70867719|NCT01786668|141221199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.399||0.038|TWO_SIDED|95.0|-1.62|-0.04|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.04|-1.62|0.038
70867720|NCT01786668|141221200|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.15|STANDARD_ERROR_OF_MEAN|6.75||0.539|TWO_SIDED|95.0|-17.38|9.08|||Normal approximation for two proportions|||Week 2||9.08|-17.38|0.539
70867721|NCT01786668|141221200|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.47|STANDARD_ERROR_OF_MEAN|7.62||0.473|TWO_SIDED|95.0|-9.46|20.4|||Normal approximation for two proportions|||Week 2||20.40|-9.46|0.473
70867722|NCT01786668|141221200|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.22|STANDARD_ERROR_OF_MEAN|6.95||0.749|TWO_SIDED|95.0|-15.85|11.4|||Normal approximation for two proportions|||Week 2||11.40|-15.85|0.749
70867723|NCT01786668|141221200|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.28|STANDARD_ERROR_OF_MEAN|8.52||0.393|TWO_SIDED|95.0|-9.43|23.98|||Normal approximation for two proportions|||Week 4||23.98|-9.43|0.393
70867724|NCT01786668|141221200|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.51|STANDARD_ERROR_OF_MEAN|8.2||0.854|TWO_SIDED|95.0|-14.57|17.59|||Normal approximation for two proportions|||Week 4||17.59|-14.57|0.854
70867725|NCT01786668|141221200|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.28|STANDARD_ERROR_OF_MEAN|8.52||0.393|TWO_SIDED|95.0|-9.43|23.98|||Normal approximation for two proportions|||Week 4||23.98|-9.43|0.393
70867726|NCT01786668|141221200|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.16|STANDARD_ERROR_OF_MEAN|9.09||0.43|TWO_SIDED|95.0|-10.65|24.97|||Normal approximation for two proportions|||Week 8||24.97|-10.65|0.430
70867727|NCT01786668|141221200|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.24|STANDARD_ERROR_OF_MEAN|9.02||0.561|TWO_SIDED|95.0|-12.44|22.92|||Normal approximation for two proportions|||Week 8||22.92|-12.44|0.561
70867728|NCT01786668|141221200|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.93|STANDARD_ERROR_OF_MEAN|9.24||0.162|TWO_SIDED|95.0|-5.17|31.04|||Normal approximation for two proportions|||Week 8||31.04|-5.17|0.162
70867729|NCT01786668|141221200|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.62|STANDARD_ERROR_OF_MEAN|9.11||0.013|TWO_SIDED|95.0|4.76|40.49|||Normal approximation for two proportions|||Week 12||40.49|4.76|0.013
70867730|NCT01786668|141221200|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.78|STANDARD_ERROR_OF_MEAN|9.07||0.038|TWO_SIDED|95.0|1.01|36.55|||Normal approximation for two proportions|||Week 12||36.55|1.01|0.038
70867731|NCT01786668|141221200|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.78|STANDARD_ERROR_OF_MEAN|9.07||0.038|TWO_SIDED|95.0|1.01|36.55|||Normal approximation for two proportions|||Week 12||36.55|1.01|0.038
70867732|NCT01786668|141221201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.272||0.164|TWO_SIDED|95.0|-0.92|0.16|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.16|-0.92|0.164
70867733|NCT01786668|141221201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.271||0.129|TWO_SIDED|95.0|-0.95|0.12|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.12|-0.95|0.129
70867734|NCT01786668|141221201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.272||0.66|TWO_SIDED|95.0|-0.66|0.42|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.42|-0.66|0.660
70867735|NCT01786668|141221201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.297||0.256|TWO_SIDED|95.0|-0.92|0.25|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.25|-0.92|0.256
70867736|NCT01786668|141221201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.296||0.048|TWO_SIDED|95.0|-1.17|0.0|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||-0.00|-1.17|0.048
70867737|NCT01786668|141221201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.297||0.318|TWO_SIDED|95.0|-0.88|0.29|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.29|-0.88|0.318
70867738|NCT01786668|141221201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.35||0.522|TWO_SIDED|95.0|-0.92|0.47|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.47|-0.92|0.522
70867739|NCT01786668|141221201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.35||0.05|TWO_SIDED|95.0|-1.38|0.0|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.00|-1.38|0.050
70867740|NCT01786668|141221201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.352||0.337|TWO_SIDED|95.0|-1.03|0.36|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.36|-1.03|0.337
70867741|NCT01786668|141221201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.373||0.214|TWO_SIDED|95.0|-1.2|0.27|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.27|-1.20|0.214
70867742|NCT01786668|141221201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|0.372||0.011|TWO_SIDED|95.0|-1.69|-0.22|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.22|-1.69|0.011
70867743|NCT01786668|141221201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.375||0.031|TWO_SIDED|95.0|-1.55|-0.08|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.08|-1.55|0.031
70867744|NCT01786668|141221202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.106||0.982|TWO_SIDED|95.0|-0.21|0.21|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.21|-0.21|0.982
70867745|NCT01786668|141221202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.106||0.151|TWO_SIDED|95.0|-0.36|0.06|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.06|-0.36|0.151
70867746|NCT01786668|141221202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.106||0.205|TWO_SIDED|95.0|-0.34|0.07|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.07|-0.34|0.205
70867747|NCT01786668|141221202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.118||0.898|TWO_SIDED|95.0|-0.25|0.22|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.22|-0.25|0.898
70867748|NCT01786668|141221202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.118||0.37|TWO_SIDED|95.0|-0.34|0.13|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.13|-0.34|0.370
70867749|NCT01786668|141221202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.119||0.288|TWO_SIDED|95.0|-0.36|0.11|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.11|-0.36|0.288
70867750|NCT01786668|141221202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.135||0.242|TWO_SIDED|95.0|-0.42|0.11|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.11|-0.42|0.242
70867751|NCT01786668|141221202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.135||0.12|TWO_SIDED|95.0|-0.48|0.06|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.06|-0.48|0.120
70950398|NCT03054337|141402076|SUPERIORITY||Least squares mean difference|0.66|STANDARD_ERROR_OF_MEAN|0.102|<|0.0001|TWO_SIDED|95.0|0.45|0.86|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||RBC Count||0.86|0.45|<0.0001
70950399|NCT03054337|141402076|SUPERIORITY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.005||0.7804|TWO_SIDED|95.0|-0.01|0.01|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Absolute Reticulocyte Count||0.01|-0.01|0.7804
70950400|NCT03054337|141402076|SUPERIORITY||Least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.005||0.0986|TWO_SIDED|95.0|0.0|0.02|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Absolute Reticulocyte Count||0.02|-0.00|0.0986
70950401|NCT03054337|141402076|SUPERIORITY||Least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.005||0.1661|TWO_SIDED|95.0|0.0|0.02|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Absolute Reticulocyte Count||0.02|-0.00|0.1661
70950402|NCT03054337|141402078|SUPERIORITY||Least squares mean difference|3.3|STANDARD_ERROR_OF_MEAN|0.942||0.001|TWO_SIDED|95.0|1.4|5.2|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Hematocrit||5.20|1.40|0.0010
70867752|NCT01786668|141221202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.136||0.031|TWO_SIDED|95.0|-0.56|-0.03|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||-0.03|-0.56|0.031
70950403|NCT03054337|141402078|SUPERIORITY||Least squares mean difference|5.3|STANDARD_ERROR_OF_MEAN|0.953|<|0.0001|TWO_SIDED|95.0|3.38|7.22|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Hematocrit||7.22|3.38|<0.0001
70950404|NCT03054337|141402078|SUPERIORITY||Least squares mean difference|7.24|STANDARD_ERROR_OF_MEAN|0.93|<|0.0001|TWO_SIDED|95.0|5.37|9.11|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Hematocrit||9.11|5.37|<0.0001
70950405|NCT03054337|141402078|SUPERIORITY||Least squares mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.152||0.5889|TWO_SIDED|95.0|-0.39|0.22|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Reticulocytes||0.22|-0.39|0.5889
70950406|NCT03054337|141402078|SUPERIORITY||Least squares mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.151||0.8074|TWO_SIDED|95.0|-0.27|0.34|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Reticulocytes||0.34|-0.27|0.8074
70950407|NCT03054337|141402078|SUPERIORITY||Least squares mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.148||0.6952|TWO_SIDED|95.0|-0.36|0.24|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Reticulocytes||0.24|-0.36|0.6952
70950408|NCT03054337|141402080|SUPERIORITY|||||||0.3702|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Iron||||0.3702
70950409|NCT03054337|141402080|SUPERIORITY|||||||0.5524|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Iron||||0.5524
70950410|NCT03054337|141402080|SUPERIORITY|||||||0.1589|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Iron||||0.1589
70950411|NCT03054337|141402080|SUPERIORITY|||||||0.0092|||||||ANCOVA|test of treatment group difference based on ANCOVA model||TIBC||||0.0092
70950412|NCT03054337|141402080|SUPERIORITY||||||<|0.0001|||||||ANCOVA|test of treatment group difference based on ANCOVA model||TIBC||||<0.0001
70950413|NCT03054337|141402080|SUPERIORITY||||||<|0.0001|||||||ANCOVA|test of treatment group difference based on ANCOVA model||TIBC||||<0.0001
70950414|NCT03054337|141402082|SUPERIORITY|||||||0.9092|||||||ANCOVA|test of treatment group difference based on ANCOVA model||||||0.9092
70867753|NCT01786668|141221202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.157||0.28|TWO_SIDED|95.0|-0.48|0.14|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.14|-0.48|0.280
70867754|NCT01786668|141221202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.157||0.099|TWO_SIDED|95.0|-0.57|0.05|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.05|-0.57|0.099
70867755|NCT01786668|141221202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.158||0.014|TWO_SIDED|95.0|-0.7|-0.08|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.08|-0.70|0.014
70867756|NCT01786668|141221203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.387||0.895|TWO_SIDED|95.0|-0.81|0.71|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.71|-0.81|0.895
70867757|NCT01786668|141221203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.386||0.033|TWO_SIDED|95.0|-1.59|-0.07|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||-0.07|-1.59|0.033
70867758|NCT01786668|141221203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.388||0.044|TWO_SIDED|95.0|-1.55|-0.02|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||-0.02|-1.55|0.044
70867759|NCT01786668|141221203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.411||0.53|TWO_SIDED|95.0|-1.07|0.55|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.55|-1.07|0.530
70950415|NCT03054337|141402082|SUPERIORITY|||||||0.1484|||||||ANCOVA|test of treatment group difference based on ANCOVA model||||||0.1484
70867760|NCT01786668|141221203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.411||0.114|TWO_SIDED|95.0|-1.46|0.16|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.16|-1.46|0.114
70867761|NCT01786668|141221203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.415||0.297|TWO_SIDED|95.0|-1.25|0.38|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.38|-1.25|0.297
70867762|NCT01786668|141221203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.37||0.377|TWO_SIDED|95.0|-1.06|0.4|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.40|-1.06|0.377
70867763|NCT01786668|141221203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.37||0.006|TWO_SIDED|95.0|-1.77|-0.31|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.31|-1.77|0.006
70867764|NCT01786668|141221203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.373||0.017|TWO_SIDED|95.0|-1.64|-0.17|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.17|-1.64|0.017
70867765|NCT01786668|141221205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.414||0.8|TWO_SIDED|95.0|-0.92|0.71|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.71|-0.92|0.800
70867766|NCT01786668|141221205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.413||0.113|TWO_SIDED|95.0|-0.16|1.47|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||1.47|-0.16|0.113
70867767|NCT01786668|141221205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|0.414||0.064|TWO_SIDED|95.0|-1.59|0.05|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.05|-1.59|0.064
70867768|NCT01786668|141221205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.368||0.972|TWO_SIDED|95.0|-0.74|0.71|||Mixed Models Analysis|||Week 4||0.71|-0.74|0.972
70867769|NCT01786668|141221205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.368||0.44|TWO_SIDED|95.0|-0.44|1.01|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||1.01|-0.44|0.440
70867770|NCT01786668|141221205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.369||0.311|TWO_SIDED|95.0|-1.1|0.35|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.35|-1.10|0.311
70950416|NCT03054337|141402082|SUPERIORITY|||||||0.1313|||||||ANCOVA|test of treatment group difference based on ANCOVA model||||||0.1313
70950417|NCT03054337|141402084|SUPERIORITY|||||||0.108|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Ferritin||||0.1080
70950418|NCT03054337|141402084|SUPERIORITY|||||||0.0002|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Ferritin||||0.0002
70950419|NCT03054337|141402084|SUPERIORITY||||||<|0.0001|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Ferritin||||<0.0001
70950420|NCT03054337|141402084|SUPERIORITY|||||||0.0672|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Hepcidin||||0.0672
70950421|NCT03054337|141402084|SUPERIORITY|||||||0.0004|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Hepcidin||||0.0004
70950422|NCT03054337|141402084|SUPERIORITY||||||<|0.0001|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Hepcidin||||<0.0001
70867771|NCT01786668|141221205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.629||0.501|TWO_SIDED|95.0|-1.66|0.82|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.82|-1.66|0.501
70867772|NCT01786668|141221205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.629||0.543|TWO_SIDED|95.0|-1.63|0.86|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.86|-1.63|0.543
70867773|NCT01786668|141221205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.636||0.287|TWO_SIDED|95.0|-1.93|0.57|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.57|-1.93|0.287
70867774|NCT01786668|141221205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.519||0.82|TWO_SIDED|95.0|-0.91|1.14|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||1.14|-0.91|0.820
70867775|NCT01786668|141221205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.52||0.711|TWO_SIDED|95.0|-0.83|1.22|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||1.22|-0.83|0.711
70867776|NCT01786668|141221205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.524||0.424|TWO_SIDED|95.0|-1.45|0.61|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.61|-1.45|0.424
70867777|NCT01786668|141221206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.203||0.785|TWO_SIDED|95.0|-0.34|0.46|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.46|-0.34|0.785
70867778|NCT01786668|141221206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.203||0.605|TWO_SIDED|95.0|-0.3|0.51|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.51|-0.30|0.605
70867779|NCT01786668|141221206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.204||0.175|TWO_SIDED|95.0|-0.68|0.12|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.12|-0.68|0.175
70867780|NCT01786668|141221206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.232||0.482|TWO_SIDED|95.0|-0.29|0.62|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.62|-0.29|0.482
70867781|NCT01786668|141221206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.231||0.288|TWO_SIDED|95.0|-0.7|0.21|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.21|-0.70|0.288
70867782|NCT01786668|141221206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.233||0.278|TWO_SIDED|95.0|-0.71|0.21|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.21|-0.71|0.278
70950423|NCT03054337|141402091|SUPERIORITY|||||||0.0895|||||||Fisher Exact|||||||0.0895
70950424|NCT03054337|141402091|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
70950425|NCT03054337|141402091|SUPERIORITY|||||||0.3845|||||||Fisher Exact|||||||0.3845
70950426|NCT01150461|141402096|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||Mann-Whitney-Wilcoxon test||||0.02
70950427|NCT01150461|141402097|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Wilcoxon (Mann-Whitney)|||Mann-Whitney-Wilcoxon test||||0.06
70867783|NCT01786668|141221206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.254||0.134|TWO_SIDED|95.0|-0.12|0.88|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.88|-0.12|0.134
71142070|NCT03192176|141778542|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|4.49||0.2003|TWO_SIDED|95.0|-14.6|3.07||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||3.07|-14.60|0.2003
71142071|NCT03192176|141778542|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|4.53||0.6692|TWO_SIDED|95.0|-10.86|6.98||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||6.98|-10.86|0.6692
70867784|NCT01786668|141221206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.254||0.397|TWO_SIDED|95.0|-0.29|0.72|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.72|-0.29|0.397
70867785|NCT01786668|141221206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.257||0.964|TWO_SIDED|95.0|-0.5|0.52|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.52|-0.50|0.964
71142072|NCT03192176|141778542|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|4.51||0.6894|TWO_SIDED|95.0|-10.68|7.08||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||7.08|-10.68|0.6894
71142073|NCT03192176|141778542|SUPERIORITY||LSMean difference|-6.1|STANDARD_ERROR_OF_MEAN|4.35||0.1627|TWO_SIDED|95.0|-14.66|2.48||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||2.48|-14.66|0.1627
70867786|NCT01786668|141221206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.269||0.155|TWO_SIDED|95.0|-0.15|0.91|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.91|-0.15|0.155
70950428|NCT01681992|141402098|NON_INFERIORITY|The lower limit of the 2-sided 97.5% confidence interval (CI) on the group difference (Inv\_MMR\_Min minus Com\_MMR) in seroresponse rate should be ≥ -5% for antibodies to measles virus when tested with ELISA.|Difference in seroresponse rate|-5.48|||||TWO_SIDED|97.5|-7.65|-3.43|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Min vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to measles virus at Day 42.||-3.43|-7.65|
70950429|NCT01681992|141402098|NON_INFERIORITY|The lower limit of the 2-sided 97.5% confidence interval (CI) on the group difference (Inv\_MMR\_Med minus Com\_MMR) in seroresponse rate should be ≥ -5% for antibodies to measles virus when tested with ELISA.|Difference in seroresponse rate|-2.08|||||TWO_SIDED|97.5|-3.96|-0.27|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Med vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to measles virus at Day 42.||-0.27|-3.96|
70950430|NCT01681992|141402099|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group difference (Inv\_MMR\_Min minus Com\_MMR) in seroresponse rate should be ≥ -5% for antibodies to mumps virus when tested with ELISA.|Difference in seroresponse rate|-0.42|||||TWO_SIDED|97.5|-1.91|1.04|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Min vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.||1.04|-1.91|
70950431|NCT01681992|141402099|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group difference (Inv\_MMR\_Med minus Com\_MMR) in seroresponse rate should be ≥ -5% for antibodies to mumps virus when tested with ELISA.|Difference in seroresponse rate|-0.58|||||TWO_SIDED|97.5|-2.11|0.91|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Med vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.||0.91|-2.11|
71142074|NCT03192176|141778542|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|4.48||0.9371|TWO_SIDED|95.0|-9.18|8.47||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||8.47|-9.18|0.9371
71142075|NCT03192176|141778542|SUPERIORITY||LSMean difference|0.8|STANDARD_ERROR_OF_MEAN|4.53||0.8521|TWO_SIDED|95.0|-8.07|9.77||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||9.77|-8.07|0.8521
71142076|NCT03192176|141778542|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|4.56||0.9367|TWO_SIDED|95.0|-8.62|9.35||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||9.35|-8.62|0.9367
70950432|NCT01681992|141402100|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group difference (Inv\_MMR\_Min minus Com\_MMR) in seroresponse rate should be ≥ -10% for antibodies to mumps virus when tested with PRNT.|Difference in seroresponse rate|-9.41|||||TWO_SIDED|97.5|-13.2|-5.62|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Min vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.||-5.62|-13.20|
70950433|NCT01681992|141402100|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group difference (Inv\_MMR\_Med minus Com\_MMR) in seroresponse rate should be ≥ -10% for antibodies to mumps virus when tested with PRNT.|Difference in seroresponse rate|-7.22|||||TWO_SIDED|97.5|-10.94|-3.49|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Med vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.||-3.49|-10.94|
71142077|NCT03192176|141778542|SUPERIORITY||LSMean difference|-8.8|STANDARD_ERROR_OF_MEAN|4.57||0.0551|TWO_SIDED|95.0|-17.82|0.19||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||0.19|-17.82|0.0551
70950434|NCT01681992|141402101|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group difference (Inv\_MMR\_Min minus Com\_MMR) in seroresponse rate should be ≥ -5% for antibodies to rubella virus when tested with ELISA.|Difference in seroresponse rate|-1.71|||||TWO_SIDED|97.5|-3.11|-0.42|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Min vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to rubella virus at Day 42.||-0.42|-3.11|
71142078|NCT03192176|141778542|SUPERIORITY||LSMean differencce|-3.2|STANDARD_ERROR_OF_MEAN|4.64||0.4936|TWO_SIDED|95.0|-12.32|5.96||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||5.96|-12.32|0.4936
70950435|NCT01681992|141402101|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group difference (Inv\_MMR\_Med minus Com\_MMR) in seroresponse rate should be ≥ -5% for antibodies to rubella virus when tested with ELISA.|Difference in seroresponse rate|-1.18|||||TWO_SIDED|97.5|-2.5|0.05|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Med vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to rubella virus at Day 42.||0.05|-2.50|
70867787|NCT01786668|141221206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.269||0.491|TWO_SIDED|95.0|-0.34|0.72|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.72|-0.34|0.491
70867788|NCT01786668|141221206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.271||0.515|TWO_SIDED|95.0|-0.71|0.36|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.36|-0.71|0.515
70867789|NCT01786668|141221207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.65|STANDARD_ERROR_OF_MEAN|1.312||0.006|TWO_SIDED|95.0|1.06|6.24|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Physical Health Score||6.24|1.06|0.006
70867790|NCT01786668|141221207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8|STANDARD_ERROR_OF_MEAN|1.305||0.004|TWO_SIDED|95.0|1.23|6.37|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Physical Health Score||6.37|1.23|0.004
70867791|NCT01786668|141221207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.36|STANDARD_ERROR_OF_MEAN|1.328||0.001|TWO_SIDED|95.0|1.74|6.98|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Physical Health Score||6.98|1.74|0.001
70867792|NCT01786668|141221207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|1.857||0.857|TWO_SIDED|95.0|-4.0|3.33|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Mental Health Score||3.33|-4.00|0.857
70867793|NCT01786668|141221207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.73|STANDARD_ERROR_OF_MEAN|1.848||0.35|TWO_SIDED|95.0|-1.91|5.37|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Mental Health Score||5.37|-1.91|0.350
70867794|NCT01786668|141221207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|1.876||0.49|TWO_SIDED|95.0|-2.4|5.0|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Mental Health Score||5.00|-2.40|0.490
70867795|NCT01786668|141221208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.048||0.125|TWO_SIDED|95.0|-0.02|0.17|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||||0.17|-0.02|0.125
70867796|NCT01786668|141221208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.048||0.207|TWO_SIDED|95.0|-0.03|0.16|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||||0.16|-0.03|0.207
70867797|NCT01786668|141221208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.049||0.013|TWO_SIDED|95.0|0.03|0.22|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||||0.22|0.03|0.013
70867798|NCT01786668|141221209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.72|STANDARD_ERROR_OF_MEAN|1.232||0.163|TWO_SIDED|95.0|-0.71|4.15|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||4.15|-0.71|0.163
70950436|NCT01681992|141402102|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Min over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to measles virus when tested with ELISA.|Adjusted GMC ratio|0.79|||||TWO_SIDED|97.5|0.72|0.88|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Min vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-measles antibodies at Day 42.||0.88|0.72|
70867799|NCT01786668|141221209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|1.232||0.955|TWO_SIDED|95.0|-2.36|2.5|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||2.50|-2.36|0.955
70867800|NCT01786668|141221209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|1.237||0.826|TWO_SIDED|95.0|-2.17|2.71|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||2.71|-2.17|0.826
70867801|NCT01786668|141221209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.54|STANDARD_ERROR_OF_MEAN|1.322||0.246|TWO_SIDED|95.0|-1.07|4.14|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||4.14|-1.07|0.246
70867802|NCT01786668|141221209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|1.318||0.467|TWO_SIDED|95.0|-1.64|3.56|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||3.56|-1.64|0.467
70867803|NCT01786668|141221209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|1.328||0.948|TWO_SIDED|95.0|-2.53|2.7|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||2.70|-2.53|0.948
70867804|NCT01786668|141221209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.69|STANDARD_ERROR_OF_MEAN|1.479||0.255|TWO_SIDED|95.0|-1.23|4.61|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||4.61|-1.23|0.255
70867805|NCT01786668|141221209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.96|STANDARD_ERROR_OF_MEAN|1.479||0.187|TWO_SIDED|95.0|-0.96|4.87|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||4.87|-0.96|0.187
70867806|NCT01786668|141221209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|1.497||0.373|TWO_SIDED|95.0|-1.62|4.29|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||4.29|-1.62|0.373
70867807|NCT01786668|141221209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.66|STANDARD_ERROR_OF_MEAN|1.643||0.313|TWO_SIDED|95.0|-1.58|4.9|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||4.90|-1.58|0.313
71142079|NCT03192176|141778542|SUPERIORITY||LSMean difference|2.1|STANDARD_ERROR_OF_MEAN|4.59||0.6404|TWO_SIDED|95.0|-6.89|11.17||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||11.17|-6.89|0.6404
71142080|NCT03192176|141778542|SUPERIORITY||LSMean difference|0.6|STANDARD_ERROR_OF_MEAN|4.45||0.8955|TWO_SIDED|95.0|-8.17|9.34||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||9.34|-8.17|0.8955
70950437|NCT01681992|141402102|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Med over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to measles virus when tested with ELISA.|Adjusted GMC ratio|0.91|||||TWO_SIDED|97.5|0.83|1.01|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Med vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-measles antibodies at Day 42.||1.01|0.83|
71142081|NCT03192176|141778542|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|4.59||0.9776|TWO_SIDED|95.0|-8.91|9.17||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||9.17|-8.91|0.9776
71142082|NCT03192176|141778542|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|4.14||0.7852|TWO_SIDED|95.0|-9.27|7.01||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||7.01|-9.27|0.7852
71142083|NCT03192176|141778542|SUPERIORITY||LSMean difference|1.2|STANDARD_ERROR_OF_MEAN|4.15||0.7812|TWO_SIDED|95.0|-7.02|9.33||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||9.33|-7.02|0.7812
70867808|NCT01786668|141221209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.95|STANDARD_ERROR_OF_MEAN|1.642||0.017|TWO_SIDED|95.0|0.71|7.19|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||7.19|0.71|0.017
70867809|NCT01786668|141221209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.51|STANDARD_ERROR_OF_MEAN|1.66||0.007|TWO_SIDED|95.0|1.23|7.78|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||7.78|1.23|0.007
70867810|NCT00762385|141221210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03164|STANDARD_ERROR_OF_MEAN|0.1247||||98.3|-0.2346|0.03164|||Mixed Models Analysis||Mean difference is galyfilcon A minus comfilcon A.|Results is overall lens effect with time as a covariate.||0.03164|-0.2346|
70867811|NCT00762385|141221211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.00556|STANDARD_ERROR_OF_MEAN|0.02287||||98.3|-0.04297|0.00556|||Mixed Models Analysis||Mean difference is galyfilcon A minus comfilcon A.|Results is overall lens effect with time as a covariate.||0.005560|-0.04297|
70950438|NCT01681992|141402103|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Min over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with ELISA.|Adjusted GMC ratio|0.82|||||TWO_SIDED|97.5|0.76|0.89|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Min vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.||0.89|0.76|
70950439|NCT01681992|141402103|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Med over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with ELISA.|Adjusted GMC ratio|0.84|||||TWO_SIDED|97.5|0.78|0.91|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Med vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.||0.91|0.78|
70950440|NCT01681992|141402104|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Min over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with PRNT.|Adjusted GMT ratio|0.6|||||TWO_SIDED|97.5|0.53|0.68|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed titers with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Min vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.||0.68|0.53|
70950441|NCT01681992|141402104|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Med over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with PRNT.|Adjusted GMT ratio|0.65|||||TWO_SIDED|97.5|0.57|0.74|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed titers with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Med vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.||0.74|0.57|
71142084|NCT03192176|141778542|SUPERIORITY||LSMean difference|-4.7|STANDARD_ERROR_OF_MEAN|4.23||0.2648|TWO_SIDED|95.0|-13.07|3.61||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||3.61|-13.07|0.2648
71142085|NCT03192176|141778542|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|4.25||0.6312|TWO_SIDED|95.0|-10.41|6.32||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||6.32|-10.41|0.6312
71142086|NCT03192176|141778542|SUPERIORITY||LSMean difference|1.4|STANDARD_ERROR_OF_MEAN|4.2||0.7416|TWO_SIDED|95.0|-6.89|9.67||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||9.67|-6.89|0.7416
71142087|NCT03192176|141778542|SUPERIORITY||LSMean difference|3.3|STANDARD_ERROR_OF_MEAN|4.12||0.4254|TWO_SIDED|95.0|-4.83|11.41||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||11.41|-4.83|0.4254
71142088|NCT03192176|141778542|SUPERIORITY||LSMean difference|3.4|STANDARD_ERROR_OF_MEAN|4.11||0.4038|TWO_SIDED|95.0|-4.66|11.54||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||11.54|-4.66|0.4038
71142089|NCT03192176|141778542|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|4.91||0.327|TWO_SIDED|95.0|-14.49|4.85||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||4.85|-14.49|0.3270
71142090|NCT03192176|141778542|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|4.85||0.7333|TWO_SIDED|95.0|-11.21|7.9||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||7.90|-11.21|0.7333
71142091|NCT03192176|141778542|SUPERIORITY||LSMean difference|-7.5|STANDARD_ERROR_OF_MEAN|4.99||0.1319|TWO_SIDED|95.0|-17.36|2.28||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||2.28|-17.36|0.1319
71142092|NCT03192176|141778542|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|5.0||0.6132|TWO_SIDED|95.0|-12.38|7.32||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||7.32|-12.38|0.6132
71142093|NCT03192176|141778542|SUPERIORITY||LSMean difference|-4.2|STANDARD_ERROR_OF_MEAN|4.98||0.4024|TWO_SIDED|95.0|-13.98|5.63||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||5.63|-13.98|0.4024
71142094|NCT03192176|141778542|SUPERIORITY||LSMean difference|-3.4|STANDARD_ERROR_OF_MEAN|4.88||0.4904|TWO_SIDED|95.0|-12.97|6.23||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||6.23|-12.97|0.4904
71142095|NCT03192176|141778542|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|4.87||0.5521|TWO_SIDED|95.0|-12.48|6.69||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||6.69|-12.48|0.5521
71142096|NCT03192176|141778542|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|4.5||0.737|TWO_SIDED|95.0|-10.38|7.35||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||7.35|-10.38|0.7370
71142097|NCT03192176|141778542|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|4.46||0.5269|TWO_SIDED|95.0|-11.62|5.96||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||5.96|-11.62|0.5269
70950442|NCT01681992|141402105|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Min over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to rubella virus when tested with ELISA.|Adjusted GMC ratio|0.89|||||TWO_SIDED|97.5|0.83|0.95|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Min vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-rubella antibodies at Day 42.||0.95|0.83|
70950443|NCT01681992|141402105|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Med over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to rubella virus when tested with ELISA.|Adjusted GMC ratio|0.88|||||TWO_SIDED|97.5|0.83|0.95|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Med vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-rubella antibodies at Day 42.||0.95|0.83|
70950444|NCT02838979|141402132|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.34||0.15|TWO_SIDED|||||P-value for the interaction of treatment and sequence|ANOVA|Two-way ANOVA was used to assess differences between the groups||||||0.15
70950445|NCT02838979|141402133|SUPERIORITY||Mean Difference (Final Values)|-7.39|STANDARD_DEVIATION|22.18||0.86|TWO_SIDED|||||P-value for the interaction of treatment and sequence|ANOVA|Two-way ANOVA was used to assess differences between the groups||||||0.86
71142098|NCT03192176|141778542|SUPERIORITY||LSMean difference|-3.9|STANDARD_ERROR_OF_MEAN|4.58||0.3937|TWO_SIDED|95.0|-12.93|5.11||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||5.11|-12.93|0.3937
71142099|NCT03192176|141778542|SUPERIORITY||LSMean difference|0.9|STANDARD_ERROR_OF_MEAN|4.59||0.846|TWO_SIDED|95.0|-8.15|9.94||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||9.94|-8.15|0.8460
70867812|NCT00762385|141221212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2726|STANDARD_ERROR_OF_MEAN|0.1064||||98.3|0.04553|0.2726|||Mixed Models Analysis||Mean difference is galyfilcon A minus comfilcon A.|Results is overall lens effect with time as a covariate.||0.2726|0.04553|
70950446|NCT02838979|141402134|SUPERIORITY||Median Difference (Final Values)|-0.1|STANDARD_DEVIATION|1.04||0.44|TWO_SIDED|||||P-value for the interaction of treatment and sequence|ANOVA|Two-way ANOVA was used to assess differences between the groups||||||0.44
70950447|NCT02838979|141402135|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_DEVIATION|0.21||0.36|TWO_SIDED|||||P-value for the interaction of treatment and sequence|ANOVA|Two-way ANOVA was used to assess differences between the groups||||||0.36
70950448|NCT02838979|141402136|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_DEVIATION|7.87||0.6|TWO_SIDED|||||P-value for the interaction of treatment and sequence|ANOVA|Two-way ANOVA was used to assess differences between the groups||||||0.60
70950449|NCT01762904|141402138|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
70950450|NCT01762904|141402139|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
71142100|NCT03192176|141778542|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|4.57||0.5673|TWO_SIDED|95.0|-11.62|6.38||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||6.38|-11.62|0.5673
70950451|NCT01762904|141402140|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
70950452|NCT01028677|141402143|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED|||||Not adjusted for multiple comparisons|t-test, 1 sided|||Analysis of fear emotion||||.61
70950453|NCT01028677|141402144|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||Positive Symptoms||||0.008
70950454|NCT01028677|141402144|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||Negative Symptoms||||0.002
70950455|NCT01028677|141402144|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||General Symptoms||||0.04
70950456|NCT01028677|141402144|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||Positive Symptoms||||0.05
70950457|NCT01028677|141402144|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||Negative Symptoms||||0.08
70950458|NCT01028677|141402144|SUPERIORITY|||||||0.025|||||||t-test, 2 sided|||General Symptoms||||0.025
70950459|NCT01028677|141402146|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||Not adjusted for multiple comparisons|t-test, 2 sided|||||||.03
70950460|NCT01028677|141402148|SUPERIORITY_OR_OTHER|||||||0.784|TWO_SIDED|||||Not adjusted for multiple comparisons|t-test, 2 sided|||IRI-total||||.784
70950461|NCT01028677|141402148|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||Distress analysis||||1.00
70950462|NCT01028677|141402148|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 2 sided|||Perspective-Taking||||.03
70950463|NCT01028677|141402148|SUPERIORITY_OR_OTHER|||||||0.135|||||||t-test, 2 sided|||Emotional empathy analysis||||.135
70867813|NCT02130570|141221222|SUPERIORITY||Incidence rate ratio|0.52||||0.02|TWO_SIDED|95.0|0.3|0.91||This is the P-value for the adjusted IRR.|Regression poissant|"Please see the Other Statistical Analysis field for adjustments."|||Adjusted for study month, Elixhauser comorbidity score, patient age, sex, language, race/ethnicity, cognitive status, health literacy, functional status one month prior to admission, caregiver status, median income by zip code, ED visits in the previous 6 months, HOSPITAL readmission risk score, inpatient unit, and primary care practice. IRR: incidence rate ratio|0.91|0.30|0.02
70950464|NCT01028677|141402148|SUPERIORITY_OR_OTHER|||||||0.681|TWO_SIDED||||||t-test, 2 sided|||Fantasy Analysis||||.681
70950465|NCT01028677|141402148|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||t-test, 2 sided|||Distress analysis||||1.00
70950466|NCT04079634|141402205|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
70950467|NCT03392168|141402251|SUPERIORITY||Least squares mean difference|-28.5||||0.0007|TWO_SIDED|95.0|-44.6|-12.4|||Mixed Models Analysis|||LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-12.4|-44.6|0.0007
70950468|NCT03392168|141402251|SUPERIORITY||Least squares mean difference|-27.8||||0.0011|TWO_SIDED|95.0|-44.2|-11.5|||Mixed Models Analysis|||LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-11.5|-44.2|0.0011
70950469|NCT03392168|141402252|SUPERIORITY||Least squares mean difference|-3.2||||0.5493|TWO_SIDED|95.0|-13.7|7.3|||Mixed Models Analysis|||At Week 1; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||7.3|-13.7|0.5493
71142101|NCT03192176|141778542|SUPERIORITY||LSMean difference|4.0|STANDARD_ERROR_OF_MEAN|4.49||0.3791|TWO_SIDED|95.0|-4.88|12.79||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||12.79|-4.88|0.3791
71142102|NCT03192176|141778542|SUPERIORITY||LSMean difference|0.9|STANDARD_ERROR_OF_MEAN|4.47||0.834|TWO_SIDED|95.0|-7.86|9.73||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||9.73|-7.86|0.8340
71142103|NCT03192176|141778542|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|4.67||0.9457|TWO_SIDED|95.0|-9.51|8.88||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||8.88|-9.51|0.9457
71142104|NCT03192176|141778542|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|4.65||0.657|TWO_SIDED|95.0|-11.22|7.09||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||7.09|-11.22|0.6570
71142105|NCT03192176|141778542|SUPERIORITY||LSMean difference|-5.7|STANDARD_ERROR_OF_MEAN|4.73||0.231|TWO_SIDED|95.0|-15.0|3.64||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||3.64|-15.00|0.2310
71142106|NCT03192176|141778542|SUPERIORITY||LSMean difference|0.6|STANDARD_ERROR_OF_MEAN|4.77||0.9066|TWO_SIDED|95.0|-8.84|9.96||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||9.96|-8.84|0.9066
71142107|NCT03192176|141778542|SUPERIORITY||LSMean differnce|-5.0|STANDARD_ERROR_OF_MEAN|4.71||0.2914|TWO_SIDED|95.0|-14.26|4.3||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||4.30|-14.26|0.2914
71142108|NCT03192176|141778542|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|4.64||0.9277|TWO_SIDED|95.0|-8.73|9.57||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||9.57|-8.73|0.9277
71142109|NCT03192176|141778542|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|4.64||0.9367|TWO_SIDED|95.0|-9.51|8.77||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||8.77|-9.51|0.9367
71142110|NCT03192176|141778542|SUPERIORITY||LSMean difference|5.1|STANDARD_ERROR_OF_MEAN|4.35||0.2407|TWO_SIDED|95.0|-3.46|13.69||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||13.69|-3.46|0.2407
71142111|NCT03192176|141778542|SUPERIORITY||LSMean difference|6.9|STANDARD_ERROR_OF_MEAN|4.55||0.1305|TWO_SIDED|95.0|-2.06|15.89||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||15.89|-2.06|0.1305
70950470|NCT03392168|141402252|SUPERIORITY||Least squares mean difference|-4.9||||0.365|TWO_SIDED|95.0|-15.7|5.9|||Mixed Models Analysis|||At week 1; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||5.9|-15.7|0.3650
71142112|NCT03192176|141778542|SUPERIORITY||LSMean difference|5.7|STANDARD_ERROR_OF_MEAN|4.59||0.2152|TWO_SIDED|95.0|-3.34|14.75||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||14.75|-3.34|0.2152
71142113|NCT03192176|141778542|SUPERIORITY||LSMean difference|7.6|STANDARD_ERROR_OF_MEAN|4.72||0.1099|TWO_SIDED|95.0|-1.73|16.89||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||16.89|-1.73|0.1099
71142114|NCT03192176|141778542|SUPERIORITY||LSMean difference|7.4|STANDARD_ERROR_OF_MEAN|4.75||0.1219|TWO_SIDED|95.0|-1.99|16.75||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||16.75|-1.99|0.1219
70867814|NCT02130570|141221223|SUPERIORITY||Incidence rate ratio|0.78||||0.01|TWO_SIDED|95.0|0.64|0.95||This is the p-value for the adjusted rate|Regression poissant|"For adjustments, please see the Other Statistical Analysis field below."|||Adjusted for study month, Elixhauser comorbidity score, patient age, sex, language, race/ethnicity, cognitive status, health literacy, functional status one month prior to admission, caregiver status, median income by zip code, ED visits in the previous 6 months, HOSPITAL readmission risk score, inpatient unit, and primary care practice. IRR: incidence rate ratio|0.95|0.64|0.01
70867815|NCT02130570|141221224|SUPERIORITY||Odds Ratio (OR)|1.08||||0.77|TWO_SIDED|95.0|0.64|1.85||This is the P-value for the adjusted Odds Ratio|Regression, Logistic|"For adjustments, please see the Other Statistical Analysis field below."|||Adjusted for study month, Elixhauser comorbidity score, patient age, sex, language, race/ethnicity, cognitive status, health literacy, functional status one month prior to admission, caregiver status, median income by zip code, ED visits in the previous 6 months, HOSPITAL readmission risk score; clustered by inpatient unit; primary care practice as a random effect . OR: odds ratio|1.85|0.64|0.77
70867816|NCT02130570|141221225|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.91|TWO_SIDED|||||This is the P-value for the adjusted difference.|Regression, Linear|"Please see the Other Statistical Analysis field for adjustments."|||Adjusted for study month, Elixhauser comorbidity score, patient age, sex, language, race/ethnicity, cognitive status, health literacy, functional status one month prior to admission, caregiver status, median income by zip code, ED visits in the previous 6 months, HOSPITAL readmission risk score; clustered by inpatient unit; primary care practice as a random effect.|||0.91
70867817|NCT02130570|141221226|SUPERIORITY||Odds Ratio, log|0.85||||0.57|TWO_SIDED|95.0|0.47|1.51||"Please see the Other Statistical Analysis field for adjustments and the P-value computed for each survey question."|Regression, Logistic||"Please see the Other Statistical Analysis field for a list of the estimated value and 95% CI for each survey question."||"Please see the Other Statistical Analysis field for adjustments."|1.51|0.47|0.57
70867818|NCT01776840|141221232|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.011|TWO_SIDED|95.0|0.59|0.96|||Log Rank|||||0.96|0.59|0.011
70867819|NCT02653872|141221279|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of Cmax for AZD7986 administered with verapamil over Cmax for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|153.4|||||TWO_SIDED|90.0|136.16|172.83|||ANOVA|||The study was designed based on a test for bioequivalence. Using an estimated standard deviation for Cmax of AZD7986 of less than or equal to 0.202, 12 evaluable subjects were deemed needed to achieve a power of 90%, at an assumed ratio of 0.95, to show that a two-sided 90% confidence interval for the ratio of Cmax between 2 treatments (AZD7986 and AZD7986+ Verapamil/Itraconazole) would be contained within the (0.8;1.25) equivalence limit. 3 extra subjects were added to compensate for dropout.||172.83|136.16|
70872212|NCT01727297|141229672|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.19|TWO_SIDED|95.0|0.45|1.17||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having sleep apnea on a patient's risk of developing AF.|The null hypothesis was that sleep apnea did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.17|0.45|0.19
70950471|NCT03392168|141402252|SUPERIORITY||Least squares mean difference|-18.3||||0.0064|TWO_SIDED|95.0|-31.3|-5.3|||Mixed Models Analysis|||At Week 2; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-5.3|-31.3|0.0064
70950472|NCT03392168|141402252|SUPERIORITY||Least squares mean difference|-19.8||||0.0039|TWO_SIDED|95.0|-33.0|-6.5|||Mixed Models Analysis|||At Week 2; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-6.5|-33.0|0.0039
70950473|NCT03392168|141402252|SUPERIORITY||Least squares mean difference|-28.9||||0.0001|TWO_SIDED|95.0|-42.9|-14.8|||Mixed Models Analysis|||At Week 3; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-14.8|-42.9|0.0001
71142115|NCT03192176|141778542|SUPERIORITY||LSMean difference|9.6|STANDARD_ERROR_OF_MEAN|4.44||0.0316|TWO_SIDED|95.0|0.85|18.36||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||18.36|0.85|0.0316
71142116|NCT03192176|141778542|SUPERIORITY||LSMean difference|6.4|STANDARD_ERROR_OF_MEAN|4.47||0.1557|TWO_SIDED|95.0|-2.44|15.16||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||15.16|-2.44|0.1557
71142117|NCT03192176|141778542|SUPERIORITY||LSMean difference|0.9|STANDARD_ERROR_OF_MEAN|4.97||0.8592|TWO_SIDED|95.0|-8.91|10.67||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||10.67|-8.91|0.8592
71142118|NCT03192176|141778542|SUPERIORITY||LSMean difference|2.1|STANDARD_ERROR_OF_MEAN|5.15||0.6891|TWO_SIDED|95.0|-8.08|12.2||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||12.20|-8.08|0.6891
71142119|NCT03192176|141778542|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|5.2||0.9481|TWO_SIDED|95.0|-10.59|9.92||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||9.92|-10.59|0.9481
71142120|NCT03192176|141778542|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|5.36||0.7246|TWO_SIDED|95.0|-12.46|8.68||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||8.68|-12.46|0.7246
71142121|NCT03192176|141778542|SUPERIORITY||LSMean difference|0.8|STANDARD_ERROR_OF_MEAN|5.45||0.8842|TWO_SIDED|95.0|-9.94|11.53||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||11.53|-9.94|0.8842
71142122|NCT03192176|141778542|SUPERIORITY||LSMean difference|1.2|STANDARD_ERROR_OF_MEAN|5.05||0.8103|TWO_SIDED|95.0|-8.74|11.17||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||11.17|-8.74|0.8103
71142123|NCT03192176|141778542|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|5.1||0.9631|TWO_SIDED|95.0|-9.81|10.28||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||10.28|-9.81|0.9631
71142124|NCT03192176|141778542|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|4.87||0.9788|TWO_SIDED|95.0|-9.73|9.47||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||9.47|-9.73|0.9788
71142125|NCT03192176|141778542|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|5.02||0.7875|TWO_SIDED|95.0|-11.26|8.54||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||8.54|-11.26|0.7875
71142126|NCT03192176|141778542|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|5.08||0.9746|TWO_SIDED|95.0|-9.85|10.17||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||10.17|-9.85|0.9746
71142127|NCT03192176|141778542|SUPERIORITY||LSMean difference|0.6|STANDARD_ERROR_OF_MEAN|5.21||0.9092|TWO_SIDED|95.0|-9.67|10.86||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||10.86|-9.67|0.9092
71142128|NCT03192176|141778542|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|5.27||0.9745|TWO_SIDED|95.0|-10.55|10.21||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||10.21|-10.55|0.9745
71142129|NCT03192176|141778542|SUPERIORITY||LSMean difference|4.7|STANDARD_ERROR_OF_MEAN|4.95||0.3458|TWO_SIDED|95.0|-5.08|14.44||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||14.44|-5.08|0.3458
71142130|NCT03192176|141778542|SUPERIORITY||LSMean differnce|3.6|STANDARD_ERROR_OF_MEAN|4.98||0.4657|TWO_SIDED|95.0|-6.17|13.45||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||13.45|-6.17|0.4657
70950474|NCT03392168|141402252|SUPERIORITY||Least squares mean difference|-23.0||||0.0019|TWO_SIDED|95.0|-37.3|-8.7|||Mixed Models Analysis|||At Week 3; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-8.7|-37.3|0.0019
70950475|NCT03392168|141402253|SUPERIORITY||Least squares mean difference|-4.3||||0.3626|TWO_SIDED|95.0|-13.6|5.0|||Mixed Models Analysis|||At Week 1; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||5.0|-13.6|0.3626
70950476|NCT03392168|141402253|SUPERIORITY||Least squares mean difference|-8.1||||0.1011|TWO_SIDED|95.0|-17.8|1.6|||Mixed Models Analysis|||At Week 1; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||1.6|-17.8|0.1011
70950477|NCT03392168|141402253|SUPERIORITY||Least squares mean difference|-15.5||||0.0017|TWO_SIDED|95.0|-25.1|-6.0|||Mixed Models Analysis|||At Week 2; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-6.0|-25.1|0.0017
71142131|NCT03192176|141778542|SUPERIORITY||LSMean difference|2.8|STANDARD_ERROR_OF_MEAN|5.07||0.5838|TWO_SIDED|95.0|-7.2|12.76||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||12.76|-7.20|0.5838
71142132|NCT03192176|141778542|SUPERIORITY||LSMean difference|1.1|STANDARD_ERROR_OF_MEAN|5.22||0.8322|TWO_SIDED|95.0|-9.18|11.39||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||11.39|-9.18|0.8322
71142133|NCT03192176|141778542|SUPERIORITY||LSMean difference|1.8|STANDARD_ERROR_OF_MEAN|5.26||0.7366|TWO_SIDED|95.0|-8.59|12.13||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||12.13|-8.59|0.7366
71142134|NCT03192176|141778542|SUPERIORITY||LSMean difference|5.6|STANDARD_ERROR_OF_MEAN|5.4||0.2971|TWO_SIDED|95.0|-4.99|16.28||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||16.28|-4.99|0.2971
71142135|NCT03192176|141778542|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|5.41||0.9562|TWO_SIDED|95.0|-10.96|10.37||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||10.37|-10.96|0.9562
71142136|NCT03192176|141778542|SUPERIORITY||0.28|8.7|STANDARD_ERROR_OF_MEAN|5.13||0.0926|TWO_SIDED|95.0|-1.44|18.76||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||18.76|-1.44|0.0926
71142137|NCT03192176|141778542|SUPERIORITY||LSMean difference|3.5|STANDARD_ERROR_OF_MEAN|5.18||0.4996|TWO_SIDED|95.0|-6.7|13.7||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||13.70|-6.70|0.4996
71142138|NCT03192176|141778542|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|4.76||0.896|TWO_SIDED|95.0|-9.99|8.75||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||8.75|-9.99|0.8960
71142139|NCT03192176|141778542|SUPERIORITY||LSMean difference|2.9|STANDARD_ERROR_OF_MEAN|4.89||0.5471|TWO_SIDED|95.0|-6.68|12.58||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||12.58|-6.68|0.5471
71142140|NCT03192176|141778542|SUPERIORITY||LSMean difference|1.7|STANDARD_ERROR_OF_MEAN|4.93||0.738|TWO_SIDED|95.0|-8.06|11.36||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||11.36|-8.06|0.7380
71142141|NCT03192176|141778542|SUPERIORITY||LSMean difference|9.6|STANDARD_ERROR_OF_MEAN|5.14||0.0644|TWO_SIDED|95.0|-0.58|19.69||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||19.69|-0.58|0.0644
71142142|NCT03192176|141778542|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|5.04||0.8475|TWO_SIDED|95.0|-10.9|8.96||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||8.96|-10.90|0.8475
70867820|NCT02653872|141221279|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of Cmax for AZD7986 administered with itraconazole over Cmax for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|60.66|||||TWO_SIDED|90.0|53.84|68.34|||ANOVA|||The study was designed based on a test for bioequivalence. Using an estimated standard deviation for Cmax of AZD7986 of less than or equal to 0.202, 12 evaluable subjects were deemed needed to achieve a power of 90%, at an assumed ratio of 0.95, to show that a two-sided 90% confidence interval for the ratio of Cmax between 2 treatments (AZD7986 and AZD7986+ Verapamil/Itraconazole) would be contained within the (0.8;1.25) equivalence limit. 3 extra subjects were added to compensate for dropout.||68.34|53.84|
70867821|NCT02653872|141221280|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of AUC for AZD7986 administered with verapamil over AUC for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|132.25|||||TWO_SIDED|90.0|121.78|143.64|||ANOVA|||The study was sized for Cmax primarily and not AUC. A two-sided 90% confidence interval for the ratio of AUC between the two treatments groups was used to determine equivalence.||143.64|121.78|
70867822|NCT02653872|141221280|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of AUC for AZD7986 administered with itraconazole over AUC for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|113.7|||||TWO_SIDED|90.0|104.69|123.49|||ANOVA|||The study was sized for Cmax primarily and not AUC. A two-sided 90% confidence interval for the ratio of AUC between the two treatments groups was used to determine equivalence.||123.49|104.69|
70867823|NCT02653872|141221281|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of AUC (0-t) for AZD7986 administered with verapamil over AUC (0-t) for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|133.51|||||TWO_SIDED|90.0|122.7|145.29|||ANOVA|||The study was sized for Cmax primarily and not AUC (0-t). A two-sided 90% confidence interval for the ratio of AUC (0-t) between the two treatments groups was used to determine equivalence.||145.29|122.70|
70867824|NCT02653872|141221281|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of AUC (0-t) for AZD7986 administered with itraconazole over AUC (0-t) for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|112.45|||||TWO_SIDED|90.0|103.34|122.37|||ANOVA|||The study was sized for Cmax primarily and not AUC (0-t). A two-sided 90% confidence interval for the ratio of AUC (0-t) between the two treatments groups was used to determine equivalence.||122.37|103.34|
70867825|NCT04545060|141221301|SUPERIORITY||adjusted relative risk ratio|0.21|||<|0.001|TWO_SIDED|95.0|0.09|0.5||two-sided, alpha=0.05|poisson regression model|||||0.50|0.09|<0.001
70867826|NCT04545060|141221319|SUPERIORITY||relative risk ratio|0.34|||<|0.001|TWO_SIDED|95.0|0.19|0.63||two-sided, alpha=0.05|poisson regression model|||||0.63|0.19|<0.001
70867827|NCT04545060|141221320|SUPERIORITY||Least squares mean difference|-1.07|||<|0.001|TWO_SIDED|95.0|-1.38|-0.76||two-sided, alpha=0.05|ANCOVA|||||-0.76|-1.38|<0.001
70867828|NCT04545060|141221322|SUPERIORITY||Least squares mean difference|-0.232||||0.007|TWO_SIDED|95.0|-0.399|-0.065||two-sided, alpha=0.05|Mixed model repeated measures|||||-0.065|-0.399|0.007
70867829|NCT04545060|141221326|SUPERIORITY||relative risk ratio|0.26||||0.002|TWO_SIDED|95.0|0.12|0.59||two-sided, alpha=0.05|poisson regression model|||||0.59|0.12|0.002
70867830|NCT02319837|141221339|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.424|||<|0.0001|TWO_SIDED|95.0|0.296|0.607||Statistical significance can be declared if p-value \<0.05.|Log Rank|||||0.607|0.296|<0.0001
70867831|NCT02319837|141221340|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|0.631||||0.0049|TWO_SIDED|95.0|0.456|0.871||Statistical significance can be declared if p-value \<0.03.|Log Rank|||||0.871|0.456|0.0049
70867832|NCT02319837|141221341|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.068|||<|0.0001|TWO_SIDED|95.0|0.033|0.141||Statistical significance can be declared if p-value \<0.02.|Log Rank|||||0.141|0.033|<0.0001
70867833|NCT02319837|141221341|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|0.331|||<|0.0001|TWO_SIDED|95.0|0.226|0.486||Statistical significance can be declared if p-value \<0.03.|Log Rank|||||0.486|0.226|<0.0001
70867834|NCT02319837|141221342|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.358|||<|0.0001|TWO_SIDED|95.0|0.263|0.488||Statistical significance can be declared if p-value \<0.02.|Log Rank|||||0.488|0.263|<0.0001
70867835|NCT02319837|141221342|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.411|0.709||Statistical significance can be declared if p-value \<0.03.|Log Rank|||||0.709|0.411|<0.0001
70867836|NCT02319837|141221344|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.443||||0.0002|TWO_SIDED|95.0|0.284|0.69|||Log Rank|||||0.690|0.284|0.0002
70867837|NCT02319837|141221344|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|0.614||||0.0171|TWO_SIDED|95.0|0.409|0.92|||Log Rank|||||0.920|0.409|0.0171
70867838|NCT02319837|141221345|OTHER||difference of percentage of participants|25.9|||<|0.0001|TWO_SIDED|95.0|20.7|31.0||P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.|Cochran-Mantel-Haenszel|||||31.0|20.7|<0.0001
70867839|NCT02319837|141221345|OTHER||difference of percentage of participants|18.8|||<|0.0001|TWO_SIDED|95.0|13.0|24.6||P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.|Cochran-Mantel-Haenszel|||||24.6|13.0|<0.0001
70950478|NCT03392168|141402253|SUPERIORITY||Least squares mean difference|-19.3||||0.0002|TWO_SIDED|95.0|-29.1|-9.4|||Mixed Models Analysis|||At Week 2; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-9.4|-29.1|0.0002
70950479|NCT03392168|141402253|SUPERIORITY||Least squares mean difference|-21.3||||0.0003|TWO_SIDED|95.0|-32.4|-10.2|||Mixed Models Analysis|||At Week 3; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-10.2|-32.4|0.0003
70950480|NCT03392168|141402253|SUPERIORITY||Least squares mean difference|-21.8||||0.0003|TWO_SIDED|95.0|-33.2|-10.4|||Mixed Models Analysis|||At Week 3; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-10.4|-33.2|0.0003
70950481|NCT03392168|141402253|SUPERIORITY||Least squares mean difference|-18.7||||0.001|TWO_SIDED|95.0|-29.5|-7.8|||Mixed Models Analysis|||At Week 4; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-7.8|-29.5|0.0010
70950482|NCT03392168|141402253|SUPERIORITY||Least squares mean difference|-21.8||||0.0002|TWO_SIDED|95.0|-32.9|-10.6|||Mixed Models Analysis|||At Week 4; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-10.6|-32.9|0.0002
70950483|NCT03392168|141402254|SUPERIORITY||Least squares mean difference|2.67||||0.3209|TWO_SIDED|95.0|-2.65|7.99|||Mixed Models Analysis|||At Week 1; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||7.99|-2.65|0.3209
71142143|NCT03192176|141778542|SUPERIORITY||LSMean difference|5.0|STANDARD_ERROR_OF_MEAN|4.86||0.3044|TWO_SIDED|95.0|-4.57|14.59||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||14.59|-4.57|0.3044
71142144|NCT03192176|141778542|SUPERIORITY||LSMean difference|4.2|STANDARD_ERROR_OF_MEAN|4.89||0.3895|TWO_SIDED|95.0|-5.42|13.86||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||13.86|-5.42|0.3895
70867840|NCT02319837|141221346|OTHER||difference of percentage of participants|7.5||||0.0439|TWO_SIDED|95.0|-0.2|15.2||P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.|Cochran-Mantel-Haenszel|||||15.2|-0.2|0.0439
70950484|NCT03392168|141402254|SUPERIORITY||Least squares mean difference|3.6||||0.1947|TWO_SIDED|95.0|-1.88|9.08|||Mixed Models Analysis|||At Week 1; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||9.08|-1.88|0.1947
70950485|NCT03392168|141402254|SUPERIORITY||Least squares mean difference|-4.58||||0.3561|TWO_SIDED|95.0|-14.4|5.24|||Mixed Models Analysis|||At Week 2; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||5.24|-14.40|0.3561
70950486|NCT03392168|141402254|SUPERIORITY||Least squares mean difference|-5.82||||0.249|TWO_SIDED|95.0|-15.79|4.16|||Mixed Models Analysis|||At Week 2; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||4.16|-15.79|0.2490
71142145|NCT03192176|141778542|SUPERIORITY||LSMean difference|-4.5|STANDARD_ERROR_OF_MEAN|6.07||0.4551|TWO_SIDED|95.0|-16.5|7.42||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||7.42|-16.50|0.4551
70867841|NCT02319837|141221346|OTHER||difference of percentage of participants|-12.9||||0.0004|TWO_SIDED|95.0|-19.8|-6.1||P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.|Cochran-Mantel-Haenszel|||||-6.1|-19.8|0.0004
70950487|NCT03392168|141402254|SUPERIORITY||Least squares mean difference|-12.68||||0.0276|TWO_SIDED|95.0|-23.992|-1.44|||Mixed Models Analysis|||At Week 3; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-1.44|-23.992|0.0276
70950488|NCT03392168|141402254|SUPERIORITY||Least squares mean difference|-7.04||||0.2223|TWO_SIDED|95.0|-18.44|4.36|||Mixed Models Analysis|||At Week 3; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||4.36|-18.44|0.2223
70867842|NCT02319837|141221347|OTHER||difference of percentage of participants|7.2||||0.0089|TWO_SIDED|95.0|1.7|12.8||P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.|Cochran-Mantel-Haenszel|||||12.8|1.7|0.0089
70867843|NCT02319837|141221347|OTHER||difference of percentage of participants|-5.0||||0.0326|TWO_SIDED|95.0|-9.4|-0.6||P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.|Cochran-Mantel-Haenszel|||||-0.6|-9.4|0.0326
70867844|NCT02319837|141221348|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.693|||<|0.0001|TWO_SIDED|95.0|0.577|0.834|||Log Rank|||||0.834|0.577|<0.0001
70867845|NCT02319837|141221348|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|1.655|||<|0.0001|TWO_SIDED|95.0|1.381|1.984|||Log Rank|||||1.984|1.381|<0.0001
70867846|NCT02319837|141221349|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.09|||<|0.0001|TWO_SIDED|95.0|0.051|0.157|||Log Rank|||||0.157|0.051|<0.0001
70867847|NCT02319837|141221350|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.546|||<|0.0001|TWO_SIDED|95.0|0.427|0.699|||Log Rank|||||0.699|0.427|<0.0001
70867848|NCT02319837|141221350|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|0.619|||<|0.0001|TWO_SIDED|95.0|0.488|0.785|||Log Rank|||||0.785|0.488|<0.0001
70867849|NCT02319837|141221351|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.261||||0.0001|TWO_SIDED|95.0|0.125|0.548|||Log Rank|||||0.548|0.125|0.0001
70950489|NCT03392168|141402254|SUPERIORITY||Least squares mean difference|-20.27||||0.0108|TWO_SIDED|95.0|-35.72|-4.82|||Mixed Models Analysis|||At Week 4; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-4.82|-35.72|0.0108
71142146|NCT03192176|141778542|SUPERIORITY||LSMean differencce|-2.2|STANDARD_ERROR_OF_MEAN|6.1||0.7182|TWO_SIDED|95.0|-14.21|9.81||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||9.81|-14.21|0.7182
70867850|NCT02319837|141221351|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|0.423||||0.0057|TWO_SIDED|95.0|0.226|0.794|||Log Rank|||||0.794|0.226|0.0057
70867851|NCT02319837|141221352|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|1.078||||0.4321|TWO_SIDED|95.0|0.894|1.301|||Log Rank|||||1.301|0.894|0.4321
70867852|NCT02319837|141221352|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|1.09||||0.3702|TWO_SIDED|95.0|0.904|1.314|||Log Rank|||||1.314|0.904|0.3702
70867853|NCT02319837|141221353|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|1.138||||0.1567|TWO_SIDED|95.0|0.954|1.357|||Log Rank|||||1.357|0.954|0.1567
70950490|NCT03392168|141402254|SUPERIORITY||Least squares mean difference|-16.67||||0.0372|TWO_SIDED|95.0|-32.34|-1.01|||Mixed Models Analysis|||At Week 4; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-1.01|-32.34|0.0372
70950491|NCT00401258|141402255|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
70950492|NCT00401258|141402256|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Average pain severity statistical analysis||||<.001
71142147|NCT03192176|141778542|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|6.21||0.6259|TWO_SIDED|95.0|-15.26|9.2||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||9.20|-15.26|0.6259
70950493|NCT00401258|141402256|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Average pain interference statistical analysis||||<.001
70950494|NCT00401258|141402257|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||||||.001
70950495|NCT00401258|141402258|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70950496|NCT00401258|141402260|SUPERIORITY_OR_OTHER|||||||0.031|||||||Mixed Models Analysis|||||||0.031
70950497|NCT00401258|141402261|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70950498|NCT00401258|141402262|SUPERIORITY_OR_OTHER|||||||0.004||||||Refers to work/school sub-scale|Mixed Models Analysis|||||||0.004
71142148|NCT03192176|141778542|SUPERIORITY||LSMean difference|6.6|STANDARD_ERROR_OF_MEAN|6.5||0.312|TWO_SIDED|95.0|-6.22|19.4||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||19.40|-6.22|0.3120
71142149|NCT03192176|141778542|SUPERIORITY||LSMean difference|-6.3|STANDARD_ERROR_OF_MEAN|6.41||0.3297|TWO_SIDED|95.0|-18.89|6.37||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||6.37|-18.89|0.3297
70950499|NCT00401258|141402262|SUPERIORITY_OR_OTHER|||||||0.087||||||Refers to social sub scale|Mixed Models Analysis|||||||0.087
70950500|NCT00401258|141402262|SUPERIORITY_OR_OTHER|||||||0.006||||||Refers to family sub scale|Mixed Models Analysis|||||||0.006
70950501|NCT00664534|141402291|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin is defined as 0.4%. If the upper 95%CI for difference in LSMeans is below 0.4% then MIX arm will be declared noninferior to GLAR arm|Least squares mean difference|-0.14|||||TWO_SIDED|95.0|-0.42|0.13|||||Least squares mean difference = (Premix insulin Lispro -Glargine)|||0.13|-0.42|
70950502|NCT00664534|141402293|SUPERIORITY_OR_OTHER||Least squares mean difference|0.05|||||TWO_SIDED|95.0|-0.18|0.29|||||Least squares mean difference = (Premix insulin Lispro - Glargine). 16 weeks|||0.29|-0.18|
70950503|NCT00664534|141402293|SUPERIORITY_OR_OTHER||Least squares mean difference|0.04|||||TWO_SIDED|95.0|-0.22|0.29|||||Least squares mean difference = (Premix insulin Lispro - Glargine). 32 weeks|||0.29|-0.22|
71142150|NCT03192176|141778542|SUPERIORITY||LSMean difference|3.1|STANDARD_ERROR_OF_MEAN|6.16||0.613|TWO_SIDED|95.0|-9.02|15.26||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||15.26|-9.02|0.6130
70950504|NCT00664534|141402293|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.08|||||TWO_SIDED|95.0|-0.33|0.18|||||Least squares mean difference = (Premix insulin Lispro - Glargine). 48 weeks|||0.18|-0.33|
70950505|NCT00664534|141402294|SUPERIORITY_OR_OTHER|||||||0.2127||95.0||||P-value is for Week 16 HbA1c \<=7.0%.|Chi-squared|||||||0.2127
70950506|NCT00664534|141402294|SUPERIORITY_OR_OTHER|||||||0.3281||95.0||||P-value is for Week 16 HbA1c \<=6.5%|Chi-squared|||||||0.3281
70950507|NCT00664534|141402294|SUPERIORITY_OR_OTHER|||||||0.2812||95.0||||P-value is for Week 32 HbA1c \<=7.0%|Chi-squared|||||||0.2812
70950508|NCT00664534|141402294|SUPERIORITY_OR_OTHER|||||||0.6963||95.0||||P-value is for Week 32 HbA1c \<=6.5%|Chi-squared|||||||0.6963
70950509|NCT00664534|141402294|SUPERIORITY_OR_OTHER|||||||0.0643||95.0||||P-value is for Week 48 HbA1c \<=7.0%|Chi-squared|||||||0.0643
70950510|NCT00664534|141402294|SUPERIORITY_OR_OTHER|||||||0.2524||95.0||||P-value is for Week 48 HbA1c \<=6.5%|Chi-squared|||||||0.2524
70950511|NCT00664534|141402296|SUPERIORITY_OR_OTHER|||||||0.6615||95.0||||P-value for Baseline|Wilcoxon (Mann-Whitney)|||||||0.6615
70950512|NCT00664534|141402296|SUPERIORITY_OR_OTHER|||||||0.9798||95.0||||P-value is for Week 16|Wilcoxon (Mann-Whitney)|||||||0.9798
70950513|NCT00664534|141402296|SUPERIORITY_OR_OTHER|||||||0.6169||95.0||||P-value for Week 32|Wilcoxon (Mann-Whitney)|||||||0.6169
70950514|NCT00664534|141402296|SUPERIORITY_OR_OTHER|||||||0.7834||95.0||||P-value for Week 48|Wilcoxon (Mann-Whitney)|||||||0.7834
70950515|NCT00664534|141402298|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-0.89|0.7|||||Least Squares Mean Difference = Premix Insulin Lispro minus Glargine.|||0.70|-0.89|
70950516|NCT00664534|141402299|SUPERIORITY_OR_OTHER|||||||0.4935||95.0|||||Fisher Exact|||||||0.4935
70950517|NCT03041792|141402302|SUPERIORITY||Least Square Mean Difference|-235.75|STANDARD_ERROR_OF_MEAN|43.13||0|TWO_SIDED|95.0|-322.25|-149.25||The p-value was calculated and was rounded to 4th decimal presenting as 0.0000, which was smaller than the required threshold of \<0.05.|Mixed Models Analysis|||Visit 4||-149.25|-322.25|0.0000
70950518|NCT03041792|141402302|SUPERIORITY||Least Square Mean Difference|-243.63|STANDARD_ERROR_OF_MEAN|47.6||0|TWO_SIDED|95.0|-339.1|-148.15||The p-value was calculated and was rounded to 4th decimal presenting as 0.0000, which was smaller than the required threshold of \<0.05.|Mixed Models Analysis|||Visit 5||-148.15|-339.10|0.0000
70950519|NCT03041792|141402307|SUPERIORITY||Least Square Mean Difference|-859.58|STANDARD_ERROR_OF_MEAN|167.76||0|TWO_SIDED|95.0|-1196.1|-523.1||The p-value was calculated and was rounded to 4th decimal presenting as 0.0000, which was smaller than the required threshold of \<0.05.|Mixed Models Analysis|||Visit 4||-523.10|-1196.1|0.0000
70950520|NCT03041792|141402307|SUPERIORITY||Least Square Mean Difference|-928.56|STANDARD_ERROR_OF_MEAN|193.8||0|TWO_SIDED|95.0|-1317.3|-539.86||The p-value was calculated and was rounded to 4th decimal presenting as 0.0000, which was smaller than the required threshold of \<0.05.|Mixed Models Analysis|||Visit 5||-539.86|-1317.3|0.0000
70950521|NCT03041792|141402308|SUPERIORITY||Least Square Mean Difference|4.95|STANDARD_ERROR_OF_MEAN|2.16||0.0263|TWO_SIDED|95.0|0.61|9.29|||Mixed Models Analysis|||Visit 4||9.29|0.61|0.0263
70950522|NCT03041792|141402308|SUPERIORITY||Least Square Mean Difference|5.35|STANDARD_ERROR_OF_MEAN|2.06||0.0121|TWO_SIDED|95.0|1.22|9.48|||Mixed Models Analysis|||Visit 5||9.48|1.22|0.0121
71142151|NCT03192176|141778542|SUPERIORITY||LSMean difference|2.2|STANDARD_ERROR_OF_MEAN|6.22||0.7292|TWO_SIDED|95.0|-10.09|14.4||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||14.40|-10.09|0.7292
71142152|NCT03192176|141778542|SUPERIORITY||LSMean difference|0.9|STANDARD_ERROR_OF_MEAN|5.6||0.8695|TWO_SIDED|95.0|-1.11|11.96||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||11.96|-1.11|0.8695
71142153|NCT03192176|141778542|SUPERIORITY||LSMean difference|3.1|STANDARD_ERROR_OF_MEAN|5.64||0.58|TWO_SIDED|95.0|-7.99|14.25||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||14.25|-7.99|0.5800
71142154|NCT03192176|141778542|SUPERIORITY||LSMean difference|2.2|STANDARD_ERROR_OF_MEAN|5.74||0.7024|TWO_SIDED|95.0|-9.11|13.5||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||13.50|-9.11|0.7024
71142155|NCT03192176|141778542|SUPERIORITY||LSMean difference|11.4|STANDARD_ERROR_OF_MEAN|5.99||0.0572|TWO_SIDED|95.0|-0.35|23.23||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||23.23|-0.35|0.0572
71142156|NCT03192176|141778542|SUPERIORITY||LSMean difference|1.6|STANDARD_ERROR_OF_MEAN|5.93||0.783|TWO_SIDED|95.0|-10.04|13.31||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||13.31|-10.04|0.7830
71142157|NCT03192176|141778542|SUPERIORITY||0.1|15.4|STANDARD_ERROR_OF_MEAN|5.71||0.0074|TWO_SIDED|95.0|4.19|26.67||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||26.67|4.19|0.0074
71142158|NCT03192176|141778542|SUPERIORITY||LSMean difference|11.0|STANDARD_ERROR_OF_MEAN|5.73||0.0551|TWO_SIDED|95.0|-0.24|22.32||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||22.32|-0.24|0.0551
71142159|NCT03192176|141778542|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|5.51||0.2959|TWO_SIDED|95.0|-16.63|5.08||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||5.08|-16.63|0.2959
70867854|NCT02319837|141221353|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|1.168||||0.0855|TWO_SIDED|95.0|0.981|1.391|||Log Rank|||||1.391|0.981|0.0855
70950523|NCT03041792|141402309|SUPERIORITY||Least Square Mean Difference|3.98|STANDARD_ERROR_OF_MEAN|2.91||0.1768|TWO_SIDED|95.0|-1.85|9.82|||Mixed Models Analysis|||Satiety (Visit 4)||9.82|-1.85|0.1768
71142160|NCT03192176|141778542|SUPERIORITY||LSMean difference|5.8|STANDARD_ERROR_OF_MEAN|5.55||0.2976|TWO_SIDED|95.0|-5.14|16.74||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||16.74|-5.14|0.2976
71142161|NCT03192176|141778542|SUPERIORITY||LSMean difference|2.0|STANDARD_ERROR_OF_MEAN|5.62||0.7236|TWO_SIDED|95.0|-9.07|13.05||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||13.05|-9.07|0.7236
71142162|NCT03192176|141778542|SUPERIORITY||LSMean difference|10.1|STANDARD_ERROR_OF_MEAN|5.88||0.0884|TWO_SIDED|95.0|-1.52|21.63||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||21.63|-1.52|0.0884
71142163|NCT03192176|141778542|SUPERIORITY||LSMean difference|-5.0|STANDARD_ERROR_OF_MEAN|5.77||0.3887|TWO_SIDED|95.0|-16.35|6.38||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||6.38|-16.35|0.3887
70950524|NCT03041792|141402309|SUPERIORITY||Least Square Mean Difference|3.43|STANDARD_ERROR_OF_MEAN|2.13||0.1137|TWO_SIDED|95.0|-0.85|7.7|||Mixed Models Analysis|||Satiety (Visit 5)||7.70|-0.85|0.1137
70950525|NCT03041792|141402309|SUPERIORITY||Least Square Mean Difference|2.85|STANDARD_ERROR_OF_MEAN|2.12||0.1858|TWO_SIDED|95.0|-1.41|7.11|||Mixed Models Analysis|||Fullness (Visit 4)||7.11|-1.41|0.1858
70950526|NCT03041792|141402309|SUPERIORITY||Least Square Mean Difference|1.41|STANDARD_ERROR_OF_MEAN|2.22||0.5288|TWO_SIDED|95.0|-3.05|5.86|||Mixed Models Analysis|||Fullness (Visit 5)||5.86|-3.05|0.5288
70950527|NCT03041792|141402309|SUPERIORITY||Least Square Mean Difference|-8.46|STANDARD_ERROR_OF_MEAN|2.91||0.0054|TWO_SIDED|95.0|-14.3|-2.61|||Mixed Models Analysis|||Prospective food consumption (Visit 4)||-2.61|-14.30|0.0054
70950528|NCT03041792|141402309|SUPERIORITY||Least Square Mean Difference|-9.78|STANDARD_ERROR_OF_MEAN|3.75||0.0117|TWO_SIDED|95.0|-17.29|-2.27|||Mixed Models Analysis|||Prospective food consumption (Visit 5)||-2.27|-17.29|0.0117
70950529|NCT03041792|141402309|SUPERIORITY||Least Square Mean Difference|-6.58|STANDARD_ERROR_OF_MEAN|2.44||0.0093|TWO_SIDED|95.0|-11.48|-1.69|||Mixed Models Analysis|||Hunger (Visit 4)||-1.69|-11.48|0.0093
70950530|NCT03041792|141402309|SUPERIORITY||Least Square Mean Difference|-6.39|STANDARD_ERROR_OF_MEAN|2.86||0.0296|TWO_SIDED|95.0|-12.12|-0.66|||Mixed Models Analysis|||Hunger (Visit 5)||-0.66|-12.12|0.0296
70950531|NCT03041792|141402310|SUPERIORITY||Least Square Mean Difference|35.56|STANDARD_ERROR_OF_MEAN|52.46||0.5008|TWO_SIDED|95.0|-69.64|140.76|||Mixed Models Analysis|||AUC0-60min (Visit 4)||140.76|-69.64|0.5008
70950532|NCT03041792|141402310|SUPERIORITY||Least Square Mean Difference|106.15|STANDARD_ERROR_OF_MEAN|48.95||0.0348|TWO_SIDED|95.0|7.86|204.44|||Mixed Models Analysis|||AUC0-60min (Visit 5)||204.44|7.86|0.0348
70950533|NCT03041792|141402310|SUPERIORITY||Least Square Mean Difference|214.24|STANDARD_ERROR_OF_MEAN|129.48||0.104|TWO_SIDED|95.0|-45.59|474.07|||Mixed Models Analysis|||AUC0-300min (Visit 4)||474.07|-45.59|0.1040
70950534|NCT03041792|141402310|SUPERIORITY||Least Square Mean Difference|348.43|STANDARD_ERROR_OF_MEAN|138.29||0.0152|TWO_SIDED|95.0|70.2|626.66|||Mixed Models Analysis|||AUC0-300min (Visit 5)||626.66|70.20|0.0152
70950535|NCT02358668|141402385|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.46||||0.57|TWO_SIDED|95.0|-6.28|11.2||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||11.20|-6.28|0.57
70867855|NCT00578383|141221370|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.11|STANDARD_ERROR_OF_MEAN|1.17||0.009|TWO_SIDED|95.0|0.5|5.8||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.025 for significance (correction factor 2).|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression and those with major depressive disorder as assessed by the 17-item Hamilton Depression Rating Scale.||5.8|0.5|0.009
70867856|NCT00578383|141221371|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.06|STANDARD_ERROR_OF_MEAN|0.38||0.006|TWO_SIDED|95.0|0.2|1.9||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.025 for significance (correction factor 2)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression and those with major depressive disorder as assessed by a visual analog scale.||1.9|0.2|0.006
70867857|NCT00578383|141221372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.1|STANDARD_ERROR_OF_MEAN|1.24||0.001|TWO_SIDED|95.0|1.3|6.9||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.025 for significance (correction factor 2).|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression and those with major depressive disorder as assessed by the PANAS (POSITIVE SCALE).||6.9|1.3|0.001
70867858|NCT00578383|141221373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|STANDARD_ERROR_OF_MEAN|1.39||0.15|TWO_SIDED|95.0|-1.1|5.1||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.025 for significance (correction factor 2).|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression and those with major depressive disorder as assessed by the PANAS (negative scale)||5.1|-1.1|0.15
70867859|NCT00578383|141221374|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5|STANDARD_ERROR_OF_MEAN|1.47||0.09|TWO_SIDED|95.0|-1.2|6.2||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression as assessed by the 17-item Hamilton Depression Rating Scale.||6.2|-1.2|0.09
70950536|NCT02358668|141402385|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.57||||0.72|TWO_SIDED|95.0|-10.3|7.11||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||7.11|-10.3|0.72
70950537|NCT02358668|141402386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25||||0.66|TWO_SIDED|95.0|-0.91|1.42||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.42|-0.91|0.66
70950538|NCT02358668|141402386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.9|TWO_SIDED|95.0|-1.03|1.18||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.18|-1.03|0.90
70950539|NCT02358668|141402387|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.86|TWO_SIDED|95.0|-0.5|0.59||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.59|-0.50|0.86
70950540|NCT02358668|141402387|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.59|TWO_SIDED|95.0|-0.66|0.38||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.38|-0.66|0.59
70950541|NCT02358668|141402388|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15||||0.62|TWO_SIDED|95.0|-0.44|0.73||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.73|-0.44|0.62
70950542|NCT02358668|141402388|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.97|TWO_SIDED|95.0|-0.52|0.55||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.55|-0.52|0.97
70950543|NCT02358668|141402389|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15||||0.4|TWO_SIDED|95.0|-0.2|0.51||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.51|-0.20|0.40
70950544|NCT02358668|141402389|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.49|TWO_SIDED|95.0|-0.21|0.44||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.44|-0.21|0.49
70950545|NCT02358668|141402390|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.84||||0.41|TWO_SIDED|95.0|-2.88|1.21||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.21|-2.88|0.41
70950546|NCT02358668|141402390|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.34||||0.15|TWO_SIDED|95.0|-3.18|0.51||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.51|-3.18|0.15
70950547|NCT02358668|141402391|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.64|TWO_SIDED|95.0|-0.29|0.18||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.18|-0.29|0.64
71142164|NCT03192176|141778542|SUPERIORITY||LSMean difference|6.2|STANDARD_ERROR_OF_MEAN|5.59||0.2671|TWO_SIDED|95.0|-4.8|17.24||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||17.24|-4.80|0.2671
71142165|NCT03192176|141778542|SUPERIORITY||LSMean difference|2.9|STANDARD_ERROR_OF_MEAN|5.63||0.6076|TWO_SIDED|95.0|-8.2|13.99||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||13.99|-8.20|0.6076
71142166|NCT03192176|141778543|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.91||0.2159|TWO_SIDED|95.0|-2.93|0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||0.67|-2.93|0.2159
71142167|NCT03192176|141778543|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.92||0.0405|TWO_SIDED|95.0|-3.7|-0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||-0.08|-3.70|0.0405
71142168|NCT03192176|141778543|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.93||0.0115|TWO_SIDED|95.0|-4.18|-0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||-0.53|-4.18|0.0115
71142169|NCT03192176|141778543|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.93||0.0553|TWO_SIDED|95.0|-3.62|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||0.04|-3.62|0.0553
71142170|NCT03192176|141778543|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.92||0.2753|TWO_SIDED|95.0|-2.82|0.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||0.80|-2.82|0.2753
71142171|NCT03192176|141778543|SUPERIORITY||LSMean difference|0.6|STANDARD_ERROR_OF_MEAN|0.91||0.514|TWO_SIDED|95.0|-1.2|2.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||2.40|-1.20|0.5140
71142172|NCT03192176|141778543|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.93||0.0178|TWO_SIDED|95.0|-4.03|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||-0.38|-4.03|0.0178
71142173|NCT03192176|141778543|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.51||0.9675|TWO_SIDED|95.0|-1.02|0.98||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||0.98|-1.02|0.9675
71142174|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.51||0.3122|TWO_SIDED|95.0|-1.52|0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||0.49|-1.52|0.3122
71142175|NCT03192176|141778543|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.51||0.9977|TWO_SIDED|95.0|-1.0|1.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||1.00|-1.00|0.9977
71142176|NCT03192176|141778543|SUPERIORITY||LSMean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.51||0.9312|TWO_SIDED|95.0|-1.05|0.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||0.97|-1.05|0.9312
71142177|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.51||0.6005|TWO_SIDED|95.0|-1.27|0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||0.74|-1.27|0.6005
70867860|NCT00578383|141221375|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.2|STANDARD_ERROR_OF_MEAN|2.11||0.19|TWO_SIDED|95.0|-3.3|9.6||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with major depressive disorder as assessed by the 17-item Hamilton Depression Rating Scale.||9.6|-3.3|0.19
70867861|NCT00578383|141221376|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.76|STANDARD_ERROR_OF_MEAN|0.51||0.15|TWO_SIDED|95.0|-0.6|2.1||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression as assessed by a visual analog scale.||2.1|-0.6|0.15
70867862|NCT00578383|141221377|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.58|STANDARD_ERROR_OF_MEAN|0.67||0.04|TWO_SIDED|95.0|-0.4|3.6||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with major depressive disorder as assessed by a visual analog scale.||3.6|-0.4|0.04
70867863|NCT00578383|141221378|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|1.67||0.004|TWO_SIDED|95.0|0.8|9.2||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression as assessed by the PANAS (positive scale)||9.2|0.8|0.004
70950548|NCT02358668|141402391|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.41|TWO_SIDED|95.0|-0.3|0.12||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.12|-0.30|0.41
71142178|NCT03192176|141778543|SUPERIORITY||LSMean difference|0.3|STANDARD_ERROR_OF_MEAN|0.51||0.5284|TWO_SIDED|95.0|-0.68|1.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||1.32|-0.68|0.5284
71142179|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.51||0.1111|TWO_SIDED|95.0|-1.82|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||0.19|-1.82|0.1111
71142180|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.35||0.1764|TWO_SIDED|95.0|-1.16|0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms Score||0.21|-1.16|0.1764
71142181|NCT03192176|141778543|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.35||0.0037|TWO_SIDED|95.0|-1.73|-0.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms||-0.34|-1.73|0.0037
71142182|NCT03192176|141778543|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.3|-0.92||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms Score||-0.92|-2.30|<0.0001
71142183|NCT03192176|141778543|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.21|-0.81||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms Score||-0.81|-2.21|<0.0001
71142184|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.35||0.1444|TWO_SIDED|95.0|-1.21|0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms Score||0.18|-1.21|0.1444
71142185|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.35||0.0088|TWO_SIDED|95.0|-1.6|-0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms Score||-0.23|-1.60|0.0088
71142186|NCT03192176|141778543|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.35||0.0005|TWO_SIDED|95.0|-1.93|-0.54||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms Score||-0.54|-1.93|0.0005
71142187|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0416|TWO_SIDED|95.0|-0.69|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||-0.01|-0.69|0.0416
70950549|NCT02358668|141402392|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.19||||0.46|TWO_SIDED|95.0|-4.43|2.05||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||2.05|-4.43|0.46
70950550|NCT02358668|141402392|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.75||||0.24|TWO_SIDED|95.0|-4.72|1.21||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.21|-4.72|0.24
70950551|NCT02358668|141402393|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.83|TWO_SIDED|95.0|-0.13|0.1||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.10|-0.13|0.83
71142188|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0353|TWO_SIDED|95.0|-0.71|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||-0.03|-0.71|0.0353
71142189|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.004|TWO_SIDED|95.0|-0.84|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||-0.16|-0.84|0.0040
71142190|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.0495|TWO_SIDED|95.0|-0.69|0.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||-0.00|-0.69|0.0495
71142191|NCT03192176|141778543|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.8665|TWO_SIDED|95.0|-0.31|0.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||0.37|-0.31|0.8665
71142192|NCT03192176|141778543|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.9303|TWO_SIDED|95.0|-0.35|0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||0.32|-0.35|0.9303
71142193|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.1039|TWO_SIDED|95.0|-0.62|0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||0.06|-0.62|0.1039
71142194|NCT03192176|141778543|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|1.54||0.2547|TWO_SIDED|95.0|-4.78|1.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||1.27|-4.78|0.2547
70950552|NCT02358668|141402393|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.48|TWO_SIDED|95.0|-0.16|0.08||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.08|-0.16|0.48
70950553|NCT02358668|141402394|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.14||||0.83|TWO_SIDED|95.0|-9.17|11.45||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||11.45|-9.17|0.83
70950554|NCT02358668|141402394|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.92||||0.86|TWO_SIDED|95.0|-11.1|9.27||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||9.27|-11.1|0.86
70950555|NCT02358668|141402395|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.6||||0.75|TWO_SIDED|95.0|-99.6|72.3||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||72.3|-99.6|0.75
70950556|NCT02358668|141402395|SUPERIORITY_OR_OTHER||Mean Difference (Net)|40.0||||0.34|TWO_SIDED|95.0|-43.9|123.9||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||123.9|-43.9|0.34
70950557|NCT02358668|141402396|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-980.0||||0.23|TWO_SIDED|95.0|-2604.0|643.8||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||643.8|-2604|0.23
71142195|NCT03192176|141778543|SUPERIORITY||LSMean difference|-3.6|STANDARD_ERROR_OF_MEAN|1.55||0.0225|TWO_SIDED|95.0|-6.6|-0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||-0.50|-6.60|0.0225
71142196|NCT03192176|141778543|SUPERIORITY||LSMean differencce|-4.3|STANDARD_ERROR_OF_MEAN|1.55||0.0058|TWO_SIDED|95.0|-7.38|-1.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||-1.26|-7.38|0.0058
71142197|NCT03192176|141778543|SUPERIORITY||LSMean difference|-3.4|STANDARD_ERROR_OF_MEAN|1.56||0.0301|TWO_SIDED|95.0|-6.48|-0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||-0.33|-6.48|0.0301
70867864|NCT00578383|141221379|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.7|STANDARD_ERROR_OF_MEAN|1.58||0.3|TWO_SIDED|95.0|1.3|5.8||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with major depressive disorder as assessed by the PANAS (positive scale)||5.8|1.3|0.30
70867865|NCT00578383|141221380|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|2.01||0.52|TWO_SIDED|95.0|-4.1|6.8||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression as assessed by the PANAS (negative scale)||6.8|-4.1|0.52
70867866|NCT00578383|141221381|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2|STANDARD_ERROR_OF_MEAN|1.43||0.1||95.0|-1.3|5.8||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with major depressive disorder as assessed by the PANAS (negative scale)||5.8|-1.3|0.10
70867867|NCT00181155|141221414|SUPERIORITY_OR_OTHER||||||<|0.007||95.0||||vs. baseline|Two-sided paired t tests|||||||<0.007
70867868|NCT00181155|141221415|SUPERIORITY_OR_OTHER||||||<|0.02||95.0||||vs. baseline|Two-sided paired t tests|||||||<0.02
70867869|NCT02012283|141221450|OTHER|paired t-test|Mean Difference (Final Values)|78.4||||0.001|TWO_SIDED|95.0||||p\<0.05 is defined as significant|t-test, 2 sided|||Difference between plain and spiced broccoli intake was compared.||||0.001
70867870|NCT02012283|141221451|OTHER|paired t-test|Mean Difference (Final Values)|101.3||||0.031|TWO_SIDED|||||p\<0.05 is defined as significant.|t-test, 2 sided|||Comparison was made to the broccoli intake with and without spices among low restraint eaters vs. the change among high restraint eaters.||||0.031
70867871|NCT00289783|141221456|EQUIVALENCE|Criteria for lot-to-lot consistency (1 month after primary vaccination): For each pair of lots and for the immune response to anti-PRP measured by Enzyme Linked Immunosorbent Assay (ELISA) the two-sided 95% confidence interval (CI) on the geometric mean concentrations (GMCs) ratio between lots is within the \[0.5; 2.0\] interval.|GMC ratio|1.12|||||TWO_SIDED|95.0|0.89|1.42||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for polyribosylribitol phosphate (PRP) as measured by ELISA.||1.42|0.89|
70867872|NCT00289783|141221456|EQUIVALENCE|Criteria for lot-to-lot consistency (1 month after primary vaccination): For each pair of lots and for the immune response to anti-PRP measured by ELISA the two-sided 95% confidence interval (CI) on the geometric mean concentrations (GMCs) ratio between lots is within the \[0.5; 2.0\] interval.|GMC ratio|1.12|||||TWO_SIDED|95.0|0.89|1.42||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for polyribosylribitol phosphate (PRP) as measured by ELISA.||1.42|0.89|
70950558|NCT02358668|141402396|SUPERIORITY_OR_OTHER||Mean Difference (Net)|323.9||||0.68|TWO_SIDED|95.0|-1269.0|1916.6||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1916.6|-1269|0.68
70950559|NCT02358668|141402397|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.0||||0.79|TWO_SIDED|95.0|-99.6|129.6||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||129.6|-99.6|0.79
70867873|NCT00289783|141221456|EQUIVALENCE|Criteria for lot-to-lot consistency (1 month after primary vaccination): For each pair of lots and for the immune response to anti-PRP measured by ELISA the two-sided 95% confidence interval (CI) on the geometric mean concentrations (GMCs) ratio between lots is within the \[0.5; 2.0\] interval.|GMC ratio|1.0|||||TWO_SIDED|95.0|0.8|1.26||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for polyribosylribitol phosphate (PRP) as measured by ELISA.||1.26|0.8|
70950560|NCT02358668|141402397|SUPERIORITY_OR_OTHER||Mean Difference (Net)|60.1||||0.29|TWO_SIDED|95.0|-52.5|172.6||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||172.6|-52.5|0.29
70950561|NCT02358668|141402398|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-120.2||||0.37|TWO_SIDED|95.0|-385.3|144.9||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||144.9|-385.3|0.37
70950562|NCT02358668|141402398|SUPERIORITY_OR_OTHER||Mean Difference (Net)|49.0||||0.69|TWO_SIDED|95.0|-198.1|296.2||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||296.2|-198.1|0.69
70950563|NCT02358668|141402400|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2||||0.57|TWO_SIDED|95.0|-9.8|5.5||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||5.5|-9.8|0.57
70867874|NCT00289783|141221457|EQUIVALENCE|For each pair of lots and for the immune response to hSBA-MenC, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the \[0.5; 2.0\] interval.|GMT ratio|1.23|||||TWO_SIDED|95.0|0.93|1.62||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup C (MenC) as measured by a serum bactericidal assay using human complement (hSBA).||1.62|0.93|
70950564|NCT02358668|141402400|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0||||0.79|TWO_SIDED|95.0|-6.6|8.6||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||8.6|-6.6|0.79
70950565|NCT02358668|141402401|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.54|TWO_SIDED|95.0|-3.4|1.8||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.8|-3.4|0.54
70950566|NCT02358668|141402401|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5||||0.68|TWO_SIDED|95.0|-2.0|3.1||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||3.1|-2.0|0.68
71142198|NCT03192176|141778543|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|1.55||0.322|TWO_SIDED|95.0|-4.59|1.51||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||1.51|-4.59|0.3220
71142199|NCT03192176|141778543|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|1.54||0.8782|TWO_SIDED|95.0|-2.8|3.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||3.27|-2.80|0.8782
71142200|NCT03192176|141778543|SUPERIORITY||LSMean difference|-4.2|STANDARD_ERROR_OF_MEAN|1.55||0.0069|TWO_SIDED|95.0|-7.27|-1.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||-1.17|-7.27|0.0069
71142201|NCT03192176|141778543|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.95||0.089|TWO_SIDED|95.0|-3.49|0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||0.25|-3.49|0.0890
71142202|NCT03192176|141778543|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.95||0.1444|TWO_SIDED|95.0|-3.25|0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||0.48|-3.25|0.1444
71142203|NCT03192176|141778543|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.97||0.1022|TWO_SIDED|95.0|-3.51|0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||0.32|-3.51|0.1022
71142204|NCT03192176|141778543|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.97||0.2342|TWO_SIDED|95.0|-3.07|0.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||0.75|-3.07|0.2342
70872213|NCT01727297|141229672|SUPERIORITY||Hazard Ratio (HR)|1.97||||0.16|TWO_SIDED|95.0|0.76|5.14||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having a family history of AF on a patient's risk of developing AF.|The null hypothesis was that family history of AF did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||5.14|0.76|0.16
70950567|NCT02358668|141402402|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.03|TWO_SIDED|95.0|-3.2|-0.1||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||-0.1|-3.2|0.03
70950568|NCT02358668|141402402|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.86|TWO_SIDED|95.0|-1.7|1.4||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.4|-1.7|0.86
70950569|NCT02358668|141402403|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.9|TWO_SIDED|95.0|-0.39|0.44||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.44|-0.39|0.90
71142205|NCT03192176|141778543|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.96||0.9906|TWO_SIDED|95.0|-1.89|1.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||1.87|-1.89|0.9906
71142206|NCT03192176|141778543|SUPERIORITY||LSMean difference|0.5|STANDARD_ERROR_OF_MEAN|0.95||0.577|TWO_SIDED|95.0|-1.34|2.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||2.40|-1.34|0.5770
70867875|NCT00289783|141221457|EQUIVALENCE|For each pair of lots and for the immune response to hSBA-MenC, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the \[0.5; 2.0\] interval.|GMT ratio|0.97|||||TWO_SIDED|95.0|0.74|1.29||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup C (MenC) as measured by a serum bactericidal assay using human complement (hSBA).||1.29|0.74|
70867876|NCT00289783|141221457|EQUIVALENCE|For each pair of lots and for the immune response to hSBA-MenC, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the \[0.5; 2.0\] interval.|GMT ratio|0.79|||||TWO_SIDED|95.0|0.6|1.04||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup C (MenC) as measured by a serum bactericidal assay using human complement (hSBA).||1.04|0.6|
70867877|NCT00289783|141221458|EQUIVALENCE|For each pair of lots and for the immune response to hSBA-MenY, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the \[0.5; 2.0\] interval.|GMT ratio|1.61|||||TWO_SIDED|95.0|1.14|2.27||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup Y (MenY) as measured by a serum bactericidal assay using human complement (hSBA).||2.27|1.14|
70867878|NCT00289783|141221458|EQUIVALENCE|For each pair of lots and for the immune response to hSBA-MenY, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the \[0.5; 2.0\] interval.|GMT ratio|1.4|||||TWO_SIDED|95.0|0.99|1.97||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup Y (MenY) as measured by a serum bactericidal assay using human complement (hSBA).||1.97|0.99|
70867879|NCT00289783|141221458|EQUIVALENCE|For each pair of lots and for the immune response to hSBA-MenY, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the \[0.5; 2.0\] interval.|GMT ratio|0.87|||||TWO_SIDED|95.0|0.62|1.21||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup Y (MenY) as measured by a serum bactericidal assay using human complement (hSBA).||1.21|0.62|
70867880|NCT00289783|141221459|NON_INFERIORITY|Criteria for immunogenicity of MenC (42 days after the fourth dose): Lower limit of the asymptotic 95% CI for the geometric mean of individual ratio of post-dose 4/pre-dose 4 is ≥ 2.|GMT ratio|12.0|||||TWO_SIDED|95.0|10.4|13.8||||||To evaluate the specific effect of a fourth dose of Menhibrix vaccine co-administered with M-M-R II and Varivax vaccines at 12 to 15 months of age in terms of a fourth dose vaccine response as measured by hSBA-MenC.||13.8|10.4|
70867881|NCT00289783|141221459|NON_INFERIORITY|Point estimate = Lower limit (LL) = Upper limit (UL) as LL and UL values were not available due to the departure from lognormal distribution (large number of imputed values)|GMT ratio|1.4|||||TWO_SIDED|95.0|1.4|1.4||||||To evaluate the specific effect of a fourth dose of Menhibrix vaccine co-administered with M-M-R II and Varivax vaccines at 12 to 15 months of age in terms of a fourth dose vaccine response as measured by hSBA-MenC.||1.4|1.4|
70867882|NCT00289783|141221460|NON_INFERIORITY|Criteria for immunogenicity of MenY (42 days after the fourth dose): Lower limit of the asymptotic 95% CI for the geometric mean of individual ratio of post-dose 4/pre-dose 4 is ≥ 2.|GMT ratio|11.8|||||TWO_SIDED|95.0|10.2|13.8||||||To evaluate the specific effect of a fourth dose of Menhibrix vaccine co-administered with M-M-R II and Varivax vaccines at 12 to 15 months of age in terms of a fourth dose vaccine response as measured by hSBA-MenY.||13.8|10.2|
70950570|NCT02358668|141402403|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.3|TWO_SIDED|95.0|-0.63|0.2||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.20|-0.63|0.30
70867883|NCT00289783|141221460|NON_INFERIORITY|Point estimate = Lower limit (LL) = Upper limit (UL) as LL and UL values were not available due to the departure from lognormal distribution (large number of imputed values).|GMT ratio|21.1|||||TWO_SIDED|95.0|21.1|21.1||||||To evaluate the specific effect of a fourth dose of Menhibrix vaccine co-administered with M-M-R II and Varivax vaccines at 12 to 15 months of age in terms of a fourth dose vaccine response as measured by hSBA-MenY.||21.1|21.1|
70867884|NCT00289783|141221464|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% CI for the difference (Menhibrix vaccine fourth dose group minus ActHIB fourth dose group) in the percentage of subjects with seroconversion ≥ 150 mIU/mL, in initially seronegative subjects (\<150 mIU/mL), for anti-measles antibody is ≥-5% (clinical limit for non-inferiority).|Difference in percentage|-0.15|||||TWO_SIDED|95.0|-2.56|3.06||||||To demonstrate the non-inferiority of M-M-R II vaccine when co-administered with a fourth dose of Menhibrix vaccine compared to M-M-R II vaccine co-administered with a fourth dose of PedvaxHIB vaccine, each co-administered with Varivax vaccine.||3.06|-2.56|
70867885|NCT00289783|141221465|NON_INFERIORITY|Criteria for non-inferiority (42 days after the fourth dose): Lower limit of the two-sided standardized asymptotic 95% CI on the difference (Menhibrix vaccine fourth dose group minus ActHIB fourth dose group) in the percentage of subjects with anti-PRP concentration ≥ 1.0 µg/mL is ≥ -10% (clinical limit for non-inferiority)|Difference in percentage|-0.04|||||TWO_SIDED|95.0|-1.78|3.57||||||To demonstrate that, following a fourth dose, the immune response to Hib polysaccharide (PRP) in the group that received 3 primary vaccine doses of Menhibrix vaccine and a fourth dose of Menhibrix vaccine coadministered with M-M-R II and Varivax vaccines was non-inferior to the corresponding immune response in the group that received 3 primary vaccine doses of ActHIB vaccine and a fourth dose of PedvaxHIB vaccine co-administered with M-M-R II and Varivax vaccines.||3.57|-1.78|
70950571|NCT02358668|141402404|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.62||||0.52|TWO_SIDED|95.0|-1.32|2.57||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||2.57|-1.32|0.52
70950572|NCT02358668|141402404|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.13||||0.24|TWO_SIDED|95.0|-0.75|3.05||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||3.05|-0.75|0.24
70950573|NCT02358668|141402405|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.002||||0.93|TWO_SIDED|95.0|-0.035|0.038||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.038|-0.035|0.93
70950574|NCT02358668|141402405|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.015||||0.4|TWO_SIDED|95.0|-0.021|0.051||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.051|-0.021|0.40
70950575|NCT02358668|141402406|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.36|TWO_SIDED|95.0|-1.2|0.5||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.5|-1.2|0.36
70950576|NCT02358668|141402406|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.36|TWO_SIDED|95.0|-0.4|1.2||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.2|-0.4|0.36
70950577|NCT02358668|141402407|SUPERIORITY_OR_OTHER|||||||0.09||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.09
70950578|NCT02358668|141402407|SUPERIORITY_OR_OTHER|||||||0.82||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.82
70950579|NCT02358668|141402408|SUPERIORITY_OR_OTHER|||||||0.68||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.68
70950580|NCT02358668|141402408|SUPERIORITY_OR_OTHER|||||||0.26||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.26
70950581|NCT02358668|141402409|SUPERIORITY_OR_OTHER|||||||0.67||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.67
70950582|NCT02358668|141402409|SUPERIORITY_OR_OTHER|||||||0.3||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.30
70950583|NCT02358668|141402410|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|||<|0.01|TWO_SIDED|95.0|-0.48|-0.11||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.11|-0.48|<0.01
70950584|NCT02358668|141402410|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.13|TWO_SIDED|95.0|-0.32|0.04||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.04|-0.32|0.13
70950585|NCT02358668|141402411|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59||||0.01|TWO_SIDED|95.0|-1.01|-0.18||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.18|-1.01|0.01
70950586|NCT02358668|141402411|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.42|TWO_SIDED|95.0|-0.57|0.24||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.24|-0.57|0.42
70950587|NCT02358668|141402412|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74||||0.02|TWO_SIDED|95.0|-1.35|-0.14||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.14|-1.35|0.02
70950588|NCT02358668|141402412|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.57|TWO_SIDED|95.0|-0.75|0.42||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.42|-0.75|0.57
70950589|NCT02358668|141402413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32|||<|0.01|TWO_SIDED|95.0|-0.52|-0.12||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.12|-0.52|<0.01
71142207|NCT03192176|141778543|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.95||0.1865|TWO_SIDED|95.0|-3.14|0.61||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||0.61|-3.14|0.1865
71142208|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.53||0.4575|TWO_SIDED|95.0|-1.45|0.65||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||0.65|-1.45|0.4575
71142209|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.53||0.6016|TWO_SIDED|95.0|-1.33|0.77||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||0.77|-1.33|0.6016
71142210|NCT03192176|141778543|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.54||0.7026|TWO_SIDED|95.0|-0.86|1.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||1.28|-0.86|0.7026
71142211|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.54||0.2971|TWO_SIDED|95.0|-1.64|0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||0.50|-1.64|0.2971
71142212|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.54||0.5491|TWO_SIDED|95.0|-1.38|0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||0.74|-1.38|0.5491
71142213|NCT03192176|141778543|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.54||0.7142|TWO_SIDED|95.0|-0.86|1.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||1.25|-0.86|0.7142
71142214|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.53||0.1157|TWO_SIDED|95.0|-1.89|0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||0.21|-1.89|0.1157
71142215|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.36||0.1114|TWO_SIDED|95.0|-1.3|0.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Symptoms Score||0.14|-1.30|0.1114
71142216|NCT03192176|141778543|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.36||0.0025|TWO_SIDED|95.0|-1.83|-0.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Symptoms Score||-0.40|-1.83|0.0025
71142217|NCT03192176|141778543|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.37|<|0.0001|TWO_SIDED|95.0|-2.2|-0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Symptoms Scre||-0.74|-2.20|<0.0001
71142218|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.37||0.5093|TWO_SIDED|95.0|-0.96|0.48|||MMRM|||Week 8: Vasomotor Symptoms Score||0.48|-0.96|0.5093
71142219|NCT03192176|141778543|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.37|<|0.0001|TWO_SIDED|95.0|-2.33|-0.86||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Symptoms Score||-0.86|-2.33|<0.0001
71142220|NCT03192176|141778543|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.36||0.009|TWO_SIDED|95.0|-1.67|-0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Symptoms Score||-0.24|-1.67|0.0090
71142221|NCT03192176|141778543|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.37||0.0024|TWO_SIDED|95.0|-1.84|-0.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|LSMean difference|||Week 4: Vasomotor Symptoms Score||-0.40|-1.84|0.0024
71142222|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.5497|TWO_SIDED|95.0|-0.47|0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Dysfunction Score||0.25|-0.47|0.5497
71142223|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0276|TWO_SIDED|95.0|-0.76|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Dysfunction Score||-0.04|-0.76|0.0276
71142224|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.1274|TWO_SIDED|95.0|-0.65|0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Dysfunction Score||0.08|-0.65|0.1274
71142225|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.1865|TWO_SIDED|95.0|-0.61|0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|LSMean difference|||Week 8: Sexual Dysfunction Score||0.12|-0.61|0.1865
71142226|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.1857|TWO_SIDED|95.0|-0.61|0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Dysfunction Score||0.12|-0.61|0.1857
71142227|NCT03192176|141778543|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.18||0.8631|TWO_SIDED|95.0|-0.33|0.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Dysfunction Score||0.39|-0.33|0.8631
71142228|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0304|TWO_SIDED|95.0|-0.75|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Dysfunction Score||-0.04|-0.75|0.0304
70950590|NCT02358668|141402413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.14|TWO_SIDED|95.0|-0.34|0.05||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.05|-0.34|0.14
70950591|NCT02358668|141402414|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31|||<|0.01|TWO_SIDED|95.0|-0.52|-0.1||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.10|-0.52|<0.01
70950592|NCT02358668|141402414|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.38|TWO_SIDED|95.0|-0.3|0.12||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.12|-0.30|0.38
70950593|NCT02358668|141402415|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.01|TWO_SIDED|95.0|-0.48|-0.07||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.07|-0.48|0.01
70950594|NCT02358668|141402415|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.41|TWO_SIDED|95.0|-0.28|0.11||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.11|-0.28|0.41
70950595|NCT02358668|141402416|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19||||0.08|TWO_SIDED|95.0|-0.4|0.03||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.03|-0.40|0.08
71142229|NCT03192176|141778543|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|1.63||0.1246|TWO_SIDED|95.0|-5.71|0.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||0.70|-5.71|0.1246
70867886|NCT00289783|141221466|NON_INFERIORITY|Criterion for non-inferiority (42 days after fourth dose vaccination): Lower limit of the standardized asymptotic 95% CI for the difference (Menhibrix vaccine fourth dose group minus ActHIB fourth dose group) in the percentage of subjects with a seroconversion ≥28 ED50, in subjects with initial anti-mumps antibody \< 28 ED50, for anti-mumps antibody is ≥ -5% (clinical limit for non-inferiority).|Difference in percentage|-1.0|||||TWO_SIDED|95.0|-2.16|0.98||||||To demonstrate the non-inferiority of M-M-R II vaccine when co-administered with a fourth dose of Menhibrix vaccine compared to M--M-R II vaccine co-administered with a fourth dose of PedvaxHIB vaccine, each co-administered with Varivax vaccine.||0.98|-2.16|
70872214|NCT01727297|141229672|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.63|TWO_SIDED|95.0|0.56|1.43||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having vascular disease on a patient's risk of developing AF.|The null hypothesis was that vascular disease did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.43|0.56|0.63
70950596|NCT02358668|141402416|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.1|TWO_SIDED|95.0|-0.38|0.03||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.03|-0.38|0.10
70950597|NCT02358668|141402417|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||0.01|TWO_SIDED|95.0|-0.67|-0.12||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.12|-0.67|0.01
71142230|NCT03192176|141778543|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|1.63||0.068|TWO_SIDED|95.0|-6.19|0.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||0.22|-6.19|0.0680
70950598|NCT02358668|141402417|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.54|TWO_SIDED|95.0|-0.35|0.18||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.18|-0.35|0.54
70950599|NCT02358668|141402418|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42||||0.03|TWO_SIDED|95.0|-0.81|-0.03||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.03|-0.81|0.03
70950600|NCT02358668|141402418|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.63|TWO_SIDED|95.0|-0.48|0.29||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.29|-0.48|0.63
70950601|NCT02358668|141402419|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.18|TWO_SIDED|95.0|-0.13|0.02||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.02|-0.13|0.18
70950602|NCT02358668|141402419|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.73|TWO_SIDED|95.0|-0.06|0.09||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.09|-0.06|0.73
70950603|NCT02358668|141402420|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.06|TWO_SIDED|95.0|-0.15|0.0||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.00|-0.15|0.06
71142231|NCT03192176|141778543|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|1.67||0.0729|TWO_SIDED|95.0|-6.28|0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||0.28|-6.28|0.0729
70950604|NCT02358668|141402420|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.46|TWO_SIDED|95.0|-0.05|0.1||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.10|-0.05|0.46
70872215|NCT02042183|141229674|OTHER|||||||0.1609||||||Cochran-Mantel-Haenszel (CMH) test stratified by baseline spontaneous bowel movement (SBM) frequency (\<1.5 or ≥1.5)|Cochran-Mantel-Haenszel|||||||0.1609
70950605|NCT02358668|141402421|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.06|TWO_SIDED|95.0|-0.15|0.0||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.00|-0.15|0.06
70950606|NCT02358668|141402421|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.46|TWO_SIDED|95.0|-0.05|0.1||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.10|-0.05|0.46
70950607|NCT02358668|141402422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16||||0.03|TWO_SIDED|95.0|-0.31|-0.02||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.02|-0.31|0.03
70950608|NCT02358668|141402422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.87|TWO_SIDED|95.0|-0.13|0.15||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.15|-0.13|0.87
70950609|NCT02358668|141402423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48||||0.34|TWO_SIDED|95.0|-1.46|0.5||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.50|-1.46|0.34
70950610|NCT02358668|141402423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22||||0.64|TWO_SIDED|95.0|-0.73|1.18||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||1.18|-0.73|0.64
70950611|NCT02358668|141402424|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.62||||0.17|TWO_SIDED|95.0|-1.5|0.26||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.26|-1.50|0.17
70872216|NCT01192516|141229678|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED||||||Mixed Models Analysis|Adjusted for age, gender, pain level, and body mass index at baseline.||||||.85
70950612|NCT02358668|141402424|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.37|TWO_SIDED|95.0|-0.46|1.24||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||1.24|-0.46|0.37
70950613|NCT02358668|141402425|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.65||||0.18|TWO_SIDED|95.0|-1.62|0.31||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.31|-1.62|0.18
70950614|NCT02358668|141402425|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.42||||0.37|TWO_SIDED|95.0|-0.51|1.36||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||1.36|-0.51|0.37
70950615|NCT02358668|141402426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.14||||0.06|TWO_SIDED|95.0|-4.36|0.09||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.09|-4.36|0.06
70950616|NCT02358668|141402426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.43||||0.69|TWO_SIDED|95.0|-1.71|2.58||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||2.58|-1.71|0.69
70950617|NCT02358668|141402427|SUPERIORITY_OR_OTHER|||||||0.29||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.29
70950618|NCT02358668|141402427|SUPERIORITY_OR_OTHER|||||||0.22||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.22
70950619|NCT02358668|141402428|SUPERIORITY_OR_OTHER|||||||0.41||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.41
70872217|NCT01192516|141229681|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Mixed Models Analysis|Adjusted for age, gender, and body mass index.||||||.06
70950620|NCT02358668|141402428|SUPERIORITY_OR_OTHER|||||||0.48||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.48
70950621|NCT02358668|141402429|SUPERIORITY_OR_OTHER|||||||0.61||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.61
70950622|NCT02358668|141402429|SUPERIORITY_OR_OTHER|||||||0.89||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.89
70950623|NCT04057573|141402430|SUPERIORITY||Odds Ratio (OR)|3.45||||0.0004|TWO_SIDED|95.0|1.737|6.835||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||6.835|1.737|0.0004
70950624|NCT04057573|141402431|SUPERIORITY||Odds Ratio (OR)|3.99|||<|0.0001|TWO_SIDED|95.0|2.296|6.949||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||6.949|2.296|< 0.0001
70950625|NCT04057573|141402432|SUPERIORITY||Odds Ratio (OR)|15.29||||0.0065|TWO_SIDED|95.0|2.15|108.739||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||108.739|2.150|0.0065
70950626|NCT04057573|141402433|SUPERIORITY||Odds Ratio (OR)|4.29||||0.0006|TWO_SIDED|95.0|1.865|9.853||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||9.853|1.865|0.0006
70867887|NCT00289783|141221467|NON_INFERIORITY|Criterion for non-inferiority (42 days after fourth dose vaccination): Lower limit of the standardized asymptotic 95% CI for the difference (Menhibrix vaccine fourth dose group minus ActHIB fourth dose group) in the percentage of subjects with seroresponse ≥10 IU/ml, in initially seronegative subjects (\< 4 IU/ml), for anti-rubella antibody is ≥ -5% (clinical limit for non-inferiority).|Difference in percentage|0.12|||||TWO_SIDED|95.0|-0.57|1.73||||||To demonstrate the non-inferiority of M-M-R II vaccine when co-administered with a fourth dose of Menhibrix vaccine compared to M-M-R II vaccine co-administered with a fourth dose of PedvaxHIB vaccine, each co-administered with Varivax vaccine.||1.73|-0.57|
70867888|NCT00289783|141221468|NON_INFERIORITY|Criterion for non-inferiority (42 days after the fourth dose vaccination): Lower limit of the standardized asymptotic 95% CI for the difference (Menhibrix vaccine fourth dose group minus ActHIB fourth dose group) in the percentage of subjects with seroconversion ≥ 1:5 dilution, in initially seronegative subjects (\< 1:5), for anti-varicella antibody is ≥ -10% (clinical limit for non-inferiority).|Difference in percentage|-0.14|||||TWO_SIDED|95.0|-0.78|1.56||||||To demonstrate the non-inferiority of Varivax vaccine co-administered with a fourth dose of Menhibrix vaccine compared to Varivax vaccine co-administered with a fourth dose of PedvaxHIB vaccine, each co-administered with M-M-R II vaccine in terms of immunogenicity to varicella as measured by fluorescent antibody to membrane antigen (FAMA).||1.56|-0.78|
70872218|NCT01192516|141229684|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED|||||Adjusted for age, gender, body mass index, and pain at baseline.|Mixed Models Analysis|||||||.36
70950627|NCT04057573|141402434|SUPERIORITY||Odds Ratio (OR)|4.86||||0.0013|TWO_SIDED|95.0|1.851|12.755||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||12.755|1.851|0.0013
70950628|NCT04057573|141402435|SUPERIORITY||Least squares mean difference|-19.5|STANDARD_ERROR_OF_MEAN|4.59|<|0.0001|TWO_SIDED|95.0|-28.46|-10.45||Response Variable = Treatment + Stratification Factors (Skin Type Fitzpatrick scale Type I, II versus Type III, IV, V, and VI, Region North America/Europe) + Baseline|ANCOVA|||||-10.45|-28.46|< 0.0001
71142232|NCT03192176|141778543|SUPERIORITY||LSMean difference|-3.2|STANDARD_ERROR_OF_MEAN|1.66||0.0541|TWO_SIDED|95.0|-6.49|0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||0.06|-6.49|0.0541
71142233|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|1.64||0.696|TWO_SIDED|95.0|-3.87|2.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||2.59|-3.87|0.6960
71142234|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|1.63||0.9725|TWO_SIDED|95.0|-3.27|3.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||3.15|-3.27|0.9725
71142235|NCT03192176|141778543|SUPERIORITY||LSMean difference|-3.3|STANDARD_ERROR_OF_MEAN|1.63||0.0419|TWO_SIDED|95.0|-6.53|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||-0.12|-6.53|0.0419
71142236|NCT03192176|141778543|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.96||0.0794|TWO_SIDED|95.0|-3.57|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||0.20|-3.57|0.0794
71142237|NCT03192176|141778543|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.98||0.1153|TWO_SIDED|95.0|-3.47|0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||0.38|-3.47|0.1153
71142238|NCT03192176|141778543|SUPERIORITY||-1.5|-1.5|STANDARD_ERROR_OF_MEAN|1.0||0.1334|TWO_SIDED|95.0|-3.47|0.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||0.46|-3.47|0.1334
71142239|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|1.0||0.3457|TWO_SIDED|95.0|-2.93|1.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||1.03|-2.93|0.3457
71142240|NCT03192176|141778543|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.99||0.2607|TWO_SIDED|95.0|-3.07|0.83||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||0.83|-3.07|0.2607
71142241|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.97||0.7816|TWO_SIDED|95.0|-2.18|1.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||1.64|-2.18|0.7816
71142242|NCT03192176|141778543|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.97||0.0955|TWO_SIDED|95.0|-3.54|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||0.29|-3.54|0.0955
71142243|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.5||0.2582|TWO_SIDED|95.0|-1.57|0.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||0.42|-1.57|0.2582
71142244|NCT03192176|141778543|SUPERIORITY||LSMean difference|0.5|STANDARD_ERROR_OF_MEAN|0.52||0.3448|TWO_SIDED|95.0|-0.53|1.52||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||1.52|-0.53|0.3448
71142245|NCT03192176|141778543|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.53||0.6587|TWO_SIDED|95.0|-0.81|1.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||1.28|-0.81|0.6587
71142246|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.53||0.8299|TWO_SIDED|95.0|-1.16|0.93||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||0.93|-1.16|0.8299
71142247|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.53||0.8129|TWO_SIDED|95.0|-1.17|0.92||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||0.92|-1.17|0.8129
71142248|NCT03192176|141778543|SUPERIORITY||LSMean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.52||0.213|TWO_SIDED|95.0|-0.37|1.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||1.66|-0.37|0.2130
70867889|NCT02400333|141221578|SUPERIORITY_OR_OTHER||Geometric mean ratio|84.85|||||TWO_SIDED|90.0|76.77|93.78||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.||93.78|76.77|
70867890|NCT02400333|141221578|SUPERIORITY_OR_OTHER||Geometric mean ratio|96.61|||||TWO_SIDED|95.0|88.22|105.79||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.||105.79|88.22|
70867891|NCT02400333|141221578|SUPERIORITY_OR_OTHER||Geometric mean ratio|92.16|||||TWO_SIDED|95.0|85.59|99.25||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.||99.25|85.59|
71142249|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.51||0.4131|TWO_SIDED|95.0|-1.42|0.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||0.59|-1.42|0.4131
71142250|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.34||0.1273|TWO_SIDED|95.0|-1.2|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||0.15|-1.20|0.1273
71142251|NCT03192176|141778543|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.35||0.0046|TWO_SIDED|95.0|-1.69|-0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||-0.31|-1.69|0.0046
71142252|NCT03192176|141778543|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.19|-0.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||-0.80|-2.19|<0.0001
71142253|NCT03192176|141778543|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.19|-0.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||-0.78|-2.19|<0.0001
71142254|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.35||0.0333|TWO_SIDED|95.0|-1.45|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||-0.06|-1.45|0.0333
71142255|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.35||0.0423|TWO_SIDED|95.0|-1.39|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||-0.02|-1.39|0.0423
71142256|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.35||0.0208|TWO_SIDED|95.0|-1.49|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||-0.12|-1.49|0.0208
71142257|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.3435|TWO_SIDED|95.0|-0.55|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||0.19|-0.55|0.3435
71142258|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.19||0.0021|TWO_SIDED|95.0|-0.98|-0.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||-0.22|-0.98|0.0021
71142259|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0408|TWO_SIDED|95.0|-0.79|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||-0.02|-0.79|0.0408
71142260|NCT03192176|141778543|SUPERIORITY||LSMean differencce|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.0911|TWO_SIDED|95.0|-0.73|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||0.05|-0.73|0.0911
71142261|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.7891|TWO_SIDED|95.0|-0.44|0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||0.33|-0.44|0.7891
71142262|NCT03192176|141778543|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.19||0.9973|TWO_SIDED|95.0|-0.38|0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||0.38|-0.38|0.9973
71142263|NCT03192176|141778543|SUPERIORITY||-0.1|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.6377|TWO_SIDED|95.0|-0.47|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||0.29|-0.47|0.6377
71142264|NCT03192176|141778543|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|1.61||0.0862|TWO_SIDED|95.0|-5.95|0.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||0.40|-5.95|0.0862
71142265|NCT03192176|141778543|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|1.65||0.1305|TWO_SIDED|95.0|-5.74|0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||0.74|-5.74|0.1305
71142266|NCT03192176|141778543|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|1.68||0.0707|TWO_SIDED|95.0|-6.34|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||0.26|-6.34|0.0707
71142267|NCT03192176|141778543|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|1.68||0.1232|TWO_SIDED|95.0|-5.92|0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||0.71|-5.92|0.1232
71142268|NCT03192176|141778543|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|1.66||0.253|TWO_SIDED|95.0|-5.18|1.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||1.37|-5.18|0.2530
71142269|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|1.64||0.9133|TWO_SIDED|95.0|-3.4|3.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||3.04|-3.40|0.9133
71142270|NCT03192176|141778543|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|1.63||0.1078|TWO_SIDED|95.0|-5.85|0.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||0.58|-5.85|0.1078
71142271|NCT03192176|141778543|SUPERIORITY||LSMean differencce|-1.9|STANDARD_ERROR_OF_MEAN|1.08||0.0719|TWO_SIDED|95.0|-4.07|0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||0.18|-4.07|0.0719
71142272|NCT03192176|141778543|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|1.09||0.1298|TWO_SIDED|95.0|-3.8|0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||0.49|-3.80|0.1298
71142273|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|1.11||0.9532|TWO_SIDED|95.0|-2.26|2.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||2.13|-2.26|0.9532
71142274|NCT03192176|141778543|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|1.12||0.751|TWO_SIDED|95.0|-1.84|2.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||2.55|-1.84|0.7510
71142275|NCT03192176|141778543|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|1.11||0.112|TWO_SIDED|95.0|-3.95|0.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||0.42|-3.95|0.1120
71142276|NCT03192176|141778543|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|1.1||0.9781|TWO_SIDED|95.0|-2.13|2.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||2.19|-2.13|0.9781
71142277|NCT03192176|141778543|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|1.1||0.206|TWO_SIDED|95.0|-3.57|0.77||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||0.77|-3.57|0.2060
70872219|NCT00378378|141229700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.258||95.0|||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for the change from basline||||0.258
71142278|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.56||0.5332|TWO_SIDED|95.0|-1.46|0.76||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||0.76|-1.46|0.5332
71142279|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.57||0.4599|TWO_SIDED|95.0|-1.54|0.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||0.70|-1.54|0.4599
71142280|NCT03192176|141778543|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|0.58||0.4752|TWO_SIDED|95.0|-0.72|1.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||1.55|-0.72|0.4752
70867892|NCT02400333|141221578|SUPERIORITY_OR_OTHER||Geometric mean ratio|89.84|||||TWO_SIDED|95.0|82.03|98.39||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.||98.39|82.03|
70867893|NCT02400333|141221578|SUPERIORITY_OR_OTHER||Geometric mean ratio|97.45|||||TWO_SIDED|95.0|90.53|104.9||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.||104.90|90.53|
70867894|NCT02400333|141221578|SUPERIORITY_OR_OTHER||Geometric mean ratio|97.07|||||TWO_SIDED|95.0|90.83|103.74||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.||103.74|90.83|
70867895|NCT02400333|141221579|SUPERIORITY_OR_OTHER||Geometric mean ratio|95.04|||||TWO_SIDED|95.0|90.33|99.99||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.||99.99|90.33|
70867896|NCT02400333|141221579|SUPERIORITY_OR_OTHER||Geometric mean ratio|95.41|||||TWO_SIDED|95.0|89.94|101.21||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.||101.21|89.94|
71142281|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.58||0.9051|TWO_SIDED|95.0|-1.21|1.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||1.07|-1.21|0.9051
70867897|NCT02400333|141221579|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.66|||||TWO_SIDED|95.0|90.53|98.98||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.||98.98|90.53|
70950629|NCT04057573|141402438|SUPERIORITY||Odds Ratio (OR)|3.76|||<|0.0001|TWO_SIDED|95.0|2.267|6.246||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||6.246|2.267|< 0.0001
70950630|NCT04057573|141402440|SUPERIORITY||Least squares mean difference|-28.59|STANDARD_ERROR_OF_MEAN|4.94|<|0.0001|TWO_SIDED|95.0|-38.33|-18.86|||mixed-effect model; repeated measurement|||||-18.86|-38.33|<0.0001
71142282|NCT03192176|141778543|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.58||0.9937|TWO_SIDED|95.0|-1.14|1.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||1.15|-1.14|0.9937
71142283|NCT03192176|141778543|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.57||0.6956|TWO_SIDED|95.0|-0.91|1.35||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||1.35|-0.91|0.6956
70867898|NCT02400333|141221579|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.67|||||TWO_SIDED|95.0|90.94|98.56||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.||98.56|90.94|
70867899|NCT02400333|141221579|SUPERIORITY_OR_OTHER||Geometric mean ratio|96.0|||||TWO_SIDED|95.0|91.87|100.33||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.||100.33|91.87|
70867900|NCT02400333|141221579|SUPERIORITY_OR_OTHER||Geometric mean ratio|96.56|||||TWO_SIDED|95.0|93.08|100.17||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.||100.17|93.08|
70867901|NCT02400333|141221580|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.96|||||TWO_SIDED|95.0|90.27|99.89||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.||99.89|90.27|
70867902|NCT02400333|141221580|SUPERIORITY_OR_OTHER||Geometric mean ratio|95.24|||||TWO_SIDED|95.0|89.81|100.99||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.||100.99|89.81|
70867903|NCT02400333|141221580|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.4|||||TWO_SIDED|95.0|90.26|98.73||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.||98.73|90.26|
70867904|NCT02400333|141221580|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.82|||||TWO_SIDED|95.0|91.36|98.42||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.||98.42|91.36|
70872220|NCT00378378|141229700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.735||95.0|||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for the change from baseline.||||0.735
70950631|NCT04057573|141402443|SUPERIORITY||least squares mean difference|-19.85|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-26.55|-13.16|||mixed-effect model; repeated measurement|||||-13.16|-26.55|<0.0001
71142284|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.57||0.2302|TWO_SIDED|95.0|-1.81|0.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||0.44|-1.81|0.2302
71142285|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.46||0.1544|TWO_SIDED|95.0|-1.55|0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.25|-1.55|0.1544
71142286|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.46||0.6847|TWO_SIDED|95.0|-1.1|0.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.72|-1.10|0.6847
71142287|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.47||0.552|TWO_SIDED|95.0|-1.2|0.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.64|-1.20|0.5520
71142288|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.47||0.3632|TWO_SIDED|95.0|-1.36|0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.50|-1.36|0.3632
71142289|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.47||0.2828|TWO_SIDED|95.0|-1.43|0.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.42|-1.43|0.2828
71142290|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.47||0.4702|TWO_SIDED|95.0|-1.24|0.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.58|-1.24|0.4702
71142291|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.47||0.8262|TWO_SIDED|95.0|-1.02|0.81||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.81|-1.02|0.8262
71142292|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3152|TWO_SIDED|95.0|-0.6|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.19|-0.60|0.3152
71142293|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4399|TWO_SIDED|95.0|-0.56|0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.24|-0.56|0.4399
71142294|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1898|TWO_SIDED|95.0|-0.67|0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.13|-0.67|0.1898
70867905|NCT02400333|141221580|SUPERIORITY_OR_OTHER||Geometric mean ratio|95.71|||||TWO_SIDED|95.0|91.78|99.82||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.||99.82|91.78|
71142295|NCT03192176|141778543|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.21||0.9791|TWO_SIDED|95.0|-0.4|0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.41|-0.40|0.9791
71142296|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.3178|TWO_SIDED|95.0|-0.61|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.20|-0.61|0.3178
71142297|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4174|TWO_SIDED|95.0|-0.57|0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.24|-0.57|0.4174
71142298|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.249|TWO_SIDED|95.0|-0.63|0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.16|-0.63|0.2490
71142299|NCT03192176|141778543|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|1.87||0.1233|TWO_SIDED|95.0|-6.57|0.79||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||0.79|-6.57|0.1233
70950632|NCT04057573|141402445|SUPERIORITY||least squares mean difference|-11.95|STANDARD_ERROR_OF_MEAN|2.68|<|0.0001|TWO_SIDED|95.0|-17.23|-6.67|||mixed-effect model; repeated measurement|||||-6.67|-17.23|<0.0001
70867906|NCT02400333|141221580|SUPERIORITY_OR_OTHER||Geometric mean ratio|96.5|||||TWO_SIDED|95.0|93.26|99.87||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.||99.87|93.26|
70867907|NCT01332500|141221603|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Triptan tablets|paired t-test 2-sided|||||||<0.001
70867908|NCT01332500|141221603|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Non-steroidal anti-inflammatory drug tablets|paired t-test 2-sided|||||||<0.001
70867909|NCT01332500|141221603|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Opioid tablets|paired t-test 2-sided|||||||0.005
70867910|NCT01332500|141221603|SUPERIORITY_OR_OTHER|||||||0.336||95.0||||Ergot tablets|paired t-test 2-sided|||||||0.336
70950633|NCT04057573|141402447|SUPERIORITY||Odds Ratio (OR)|3.75|||<|0.0001|TWO_SIDED|95.0|2.121|6.63||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||T-VASI25||6.630|2.121|< 0.0001
70950634|NCT04057573|141402447|SUPERIORITY||Odds Ratio (OR)|4.59||||0.0436|TWO_SIDED|95.0|1.045|20.192||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||T-VASI75||20.192|1.045|0.0436
70867911|NCT01332500|141221603|SUPERIORITY_OR_OTHER|||||||0.162||95.0||||Other tablets|paired t-test 2-sided|||||||0.162
70867912|NCT01332500|141221604|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Triptan health plan costs|paired t-test 2-sided|||||||<0.001
70867913|NCT01332500|141221604|SUPERIORITY_OR_OTHER|||||||0.349||95.0||||Non-steroidal anti-inflammatory drug health plan costs|paired t-test 2-sided|||||||0.349
70867914|NCT01332500|141221604|SUPERIORITY_OR_OTHER|||||||0.208||95.0||||Opioid health plan costs|paired t-test 2-sided|||||||0.208
70867915|NCT01332500|141221604|SUPERIORITY_OR_OTHER|||||||0.239||95.0||||Ergot health plan costs|paired t-test 2-sided|||||||0.239
70950635|NCT04057573|141402447|SUPERIORITY||Odds Ratio (OR)|1.35||||||||||The p value was not evaluable because the response rate in the vehicle group was too low.||||T-VASI90||||
70867916|NCT01332500|141221604|SUPERIORITY_OR_OTHER|||||||0.583||95.0||||Other health plan costs|paired t-test 2-sided|||||||0.583
70867917|NCT01332500|141221604|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total heath plan costs|paired t-test 2-sided|||||||<0.001
70867918|NCT01332500|141221605|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Triptan health plus copay costs|paired t-test 2-sided|||||||<0.001
70867919|NCT01332500|141221605|SUPERIORITY_OR_OTHER|||||||0.177||95.0||||Non-steroidal, anti-inflammatory drug health plus copay costs|paired t-test 2-sided|||||||0.177
70867920|NCT01332500|141221605|SUPERIORITY_OR_OTHER|||||||0.173||95.0||||Opioid health plus copay costs|paired t-test 2-sided|||||||0.173
70867921|NCT01332500|141221605|SUPERIORITY_OR_OTHER|||||||0.191||95.0||||Ergot health plus copay costs|paired t-test 2-sided|||||||0.191
70867922|NCT01332500|141221605|SUPERIORITY_OR_OTHER|||||||0.254||95.0||||Other health plus copay costs|paired t-test 2-sided|||||||0.254
70867923|NCT01332500|141221605|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total health plus copay costs|paired t-test 2-sided|||||||<0.001
70867924|NCT01332500|141221606|SUPERIORITY_OR_OTHER|||||||0.866||95.0||||Triptan tablets|paired t-test 2-sided|||||||0.866
70867925|NCT01332500|141221606|SUPERIORITY_OR_OTHER|||||||0.094||95.0||||Non-steroidal anti-inflammatory drug tablets|paired t-test 2-sided|||||||0.094
70867926|NCT01332500|141221606|SUPERIORITY_OR_OTHER|||||||0.832||95.0||||Opioid tablets|paired t-test 2-sided|||||||0.832
70867927|NCT01332500|141221606|SUPERIORITY_OR_OTHER|||||||0.392||95.0||||Ergot tablets|paired t-test 2-sided|||||||0.392
70867928|NCT01332500|141221606|SUPERIORITY_OR_OTHER|||||||0.752||95.0||||Other tablets|paired t-test 2-sided|||||||0.752
70867929|NCT01332500|141221607|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Triptan health plan costs|paired t-test 2-sided|||||||<0.001
70867930|NCT01332500|141221607|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||Non-steroidal anti-inflammatory drug health plan costs|paired t-test 2-sided|||||||0.054
70867931|NCT01332500|141221607|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||Opioid health plan costs|paired t-test 2-sided|||||||0.590
70867932|NCT01332500|141221607|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||Ergot health plan costs|paired t-test 2-sided|||||||0.382
70867933|NCT01332500|141221607|SUPERIORITY_OR_OTHER|||||||0.343||95.0||||Other health plan costs|paired t-test 2-sided|||||||0.343
70867934|NCT01332500|141221607|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total health plan costs|paired t-test 2-sided|||||||<0.001
70867935|NCT01332500|141221608|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Triptan health plus copay costs|paired t-test 2-sided|||||||<0.001
70867936|NCT01332500|141221608|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||Non-steroidal anti-inflammatory drug health plus copay costs|paired t-test 2-sided|||||||0.146
70867937|NCT01332500|141221608|SUPERIORITY_OR_OTHER|||||||0.826||95.0||||Opioid health plus copay costs|paired t-test 2-sided|||||||0.826
70867938|NCT01332500|141221608|SUPERIORITY_OR_OTHER|||||||0.354||95.0||||Ergot health plus copay costs|paired t-test 2-sided|||||||0.354
70867939|NCT01332500|141221608|SUPERIORITY_OR_OTHER|||||||0.514||95.0||||Other health plus copay costs|paired t-test 2-sided|||||||0.514
70867940|NCT01332500|141221608|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Total health plus copay costs|paired t-test 2-sided|||||||0.001
70867941|NCT01034631|141221612|OTHER|||||||0.6625|||||||Chi-squared|||||||.6625
70867942|NCT01890473|141221637|SUPERIORITY_OR_OTHER||ratio of geometric mean|0.908|||||TWO_SIDED|90.0|0.815|1.01||||||The PK comparability of the two devices was assessed via a linear model for each key PK parameter in log scale (using log (Cmax) without a formal test.||1.01|0.815|
70867943|NCT01890473|141221638|SUPERIORITY_OR_OTHER||ratio of geometric mean|0.941|||||TWO_SIDED|90.0|0.843|1.05||||||The PK comparability of the two devices was assessed via a linear model for each key PK parameter in log scale, using log (AUC (0-T) without a formal test.||1.05|0.843|
70867944|NCT01890473|141221639|SUPERIORITY_OR_OTHER||ratio of geometric mean|0.976|||||TWO_SIDED|90.0|0.888|1.07||||||The PK comparability of the two devices was assessed via a linear model for each key PK parameter in log scale, using log AUC(INF) without a formal test.||1.07|0.888|
70867945|NCT00934089|141221673|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.07||||0.533|TWO_SIDED|90.0|-1.82|3.95|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on analysis of covariance (ANCOVA) using statistical analysis system (SAS) mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||3.95|-1.82|0.5330
70867946|NCT00934089|141221673|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14||||0.9532|TWO_SIDED|90.0|-4.13|3.85|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||3.85|-4.13|0.9532
70867947|NCT00934089|141221673|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.53||||0.2493|TWO_SIDED|90.0|-1.11|6.18|||ANCOVA|||Change at Day 14 12 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||6.18|-1.11|0.2493
70867948|NCT00934089|141221673|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.99||||0.2801|TWO_SIDED|90.0|-7.59|1.6|||ANCOVA|||Change at Day 14 2 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||1.60|-7.59|0.2801
70867949|NCT00934089|141221673|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19||||0.9288|TWO_SIDED|90.0|-3.77|3.39|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||3.39|-3.77|0.9288
70867950|NCT00934089|141221673|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.98||||0.6459|TWO_SIDED|90.0|-2.62|4.58|||ANCOVA|||Change at Day 14 6 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||4.58|-2.62|0.6459
70867951|NCT00934089|141221673|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.06||||0.0527|TWO_SIDED|90.0|0.63|7.48|||ANCOVA|||Change at Day 14 8 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||7.48|0.63|0.0527
70872221|NCT00378378|141229700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.194||95.0|||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for the change from baseline.||||0.194
71142300|NCT03192176|141778543|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|1.9||0.2858|TWO_SIDED|95.0|-5.76|1.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||1.70|-5.76|0.2858
71142301|NCT03192176|141778543|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|1.93||0.9716|TWO_SIDED|95.0|-3.87|3.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||3.73|-3.87|0.9716
71142302|NCT03192176|141778543|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|1.93||0.9072|TWO_SIDED|95.0|-3.58|4.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||4.03|-3.58|0.9072
71142303|NCT03192176|141778543|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|1.92||0.2334|TWO_SIDED|95.0|-6.07|1.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||1.49|-6.07|0.2334
71142304|NCT03192176|141778543|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|1.91||0.9859|TWO_SIDED|95.0|-3.79|3.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||3.72|-3.79|0.9859
71142305|NCT03192176|141778543|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|1.9||0.287|TWO_SIDED|95.0|-5.77|1.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||1.72|-5.77|0.2870
71142306|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.42||0.1632|TWO_SIDED|95.0|-1.41|0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||0.24|-1.41|0.1632
71142307|NCT03192176|141778544|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.42||0.0045|TWO_SIDED|95.0|-2.03|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||-0.38|-2.03|0.0045
71142308|NCT03192176|141778544|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.42||0.0002|TWO_SIDED|95.0|-2.43|-0.77||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||-0.77|-2.43|0.0002
71142309|NCT03192176|141778544|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-2.7|-1.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||-1.02|-2.70|<0.0001
71142310|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.42||0.8569|TWO_SIDED|95.0|-0.91|0.76||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||0.76|-0.91|0.8569
71142311|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.42||0.111|TWO_SIDED|95.0|-1.49|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||0.15|-1.49|0.1110
71142312|NCT03192176|141778544|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.42||0.0187|TWO_SIDED|95.0|-1.83|-0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||-0.17|-1.83|0.0187
71142313|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.4972|TWO_SIDED|95.0|-0.73|0.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.36|-0.73|0.4972
70872222|NCT00378378|141229701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.361||95.0|||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for baseline to endpoint||||0.361
70950636|NCT04057573|141402450|SUPERIORITY||least squares mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.51||0.235|TWO_SIDED|95.0|-1.6|0.39|||mixed-effect model; repeated measurement|||||0.39|-1.60|0.2350
70950637|NCT02271984|141402467|SUPERIORITY_OR_OTHER||Ratio (%)|39.9|||||TWO_SIDED|90.0|34.7|46.0|||||Percentage of Geometric Least Squares (LS) Mean Ratio (Treatment A/Treatment B) is reported.|||46.0|34.7|
70950638|NCT02271984|141402467|SUPERIORITY_OR_OTHER||Ratio (%)|27.3|||||TWO_SIDED|90.0|22.5|33.2|||||Percentage of Geometric LS Mean Ratio (Treatment C1/Treatment A) is reported.|||33.2|22.5|
70950639|NCT02271984|141402467|SUPERIORITY_OR_OTHER||Ratio (%)|260.2|||||TWO_SIDED|90.0|214.0|316.4|||||Percentage of Geometric LS Mean Ratio (Treatment C2/Treatment A) is reported.|||316.4|214.0|
70950640|NCT02271984|141402467|SUPERIORITY_OR_OTHER||Ratio (%)|167.1|||||TWO_SIDED|90.0|143.9|194.0|||||Percentage of Geometric LS Mean Ratio (Treatment A/Treatment D) is reported.|||194.0|143.9|
71142314|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.28||0.2568|TWO_SIDED|95.0|-0.86|0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.23|-0.86|0.2568
71142315|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.28||0.2609|TWO_SIDED|95.0|-0.86|0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.23|-0.86|0.2609
71142316|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.4148|TWO_SIDED|95.0|-0.78|0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.32|-0.78|0.4148
70950641|NCT02271984|141402467|SUPERIORITY_OR_OTHER||Ratio (%)|115.7|||||TWO_SIDED|90.0|99.8|134.1|||||Percentage of Geometric LS Mean Ratio (Treatment E/Treatment A) is reported.|||134.1|99.8|
70950642|NCT01020877|141402481|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test\[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|110.0|||||TWO_SIDED|90.0|103.0|117.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||117|103|
70950643|NCT01020877|141402482|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.0|||||TWO_SIDED|90.0|98.2|115.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||115|98.2|
70950644|NCT01020877|141402483|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.0|||||TWO_SIDED|90.0|97.6|115.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||115|97.6|
70950645|NCT04307940|141402487|SUPERIORITY||LS Mean Difference|14.81||||0.001|TWO_SIDED|95.0|6.1|23.51||All p-values were presented using two-sided test with alpha 0.05 and were considered statistically significant.|ANCOVA|||||23.51|6.10|0.001
70950646|NCT04307940|141402487|SUPERIORITY||LS Mean Difference|39.63|||<|0.001|TWO_SIDED|95.0|29.08|50.18||All p-values were presented using two-sided test with alpha 0.05 and were considered statistically significant.|ANCOVA|||||50.18|29.08|<0.001
70950647|NCT04307940|141402487|SUPERIORITY||LS Mean Difference|24.82|||<|0.001|TWO_SIDED|95.0|14.26|35.39||All p-values were presented using two-sided test with alpha 0.05 and were considered statistically significant.|ANCOVA|||||35.39|14.26|<0.001
70950648|NCT04624243|141402496|SUPERIORITY|It was hypothesized that MK-8189 16 mg is superior to placebo in reducing Week 6 PANSS change from baseline|LS Mean Difference|-2.8||||0.241|TWO_SIDED|97.5|-8.3|2.6|||ANCOVA|||||2.6|-8.3|0.241
70950649|NCT04624243|141402496|SUPERIORITY|It was hypothesized that MK-8189 24 mg is superior to placebo in reducing Week 6 PANSS change from baseline|LS Mean Difference|-0.7||||0.784|TWO_SIDED|97.5|-6.3|4.9|||ANCOVA|||||4.9|-6.3|0.784
71142317|NCT03192176|141778544|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.28||0.5575|TWO_SIDED|95.0|-0.38|0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.71|-0.38|0.5575
70867952|NCT00934089|141221673|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.29||||0.1998|TWO_SIDED|90.0|-0.95|7.52|||ANCOVA|||Change at Day 14 10 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||7.52|-0.95|0.1998
70867953|NCT00934089|141221673|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85||||0.6765|TWO_SIDED|90.0|-4.22|2.53|||ANCOVA|||Change at Day 15 12 AM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||2.53|-4.22|0.6765
70867954|NCT00934089|141221673|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.99||||0.6221|TWO_SIDED|90.0|-2.35|4.33|||ANCOVA|||Change at Day 15 4 AM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||4.33|-2.35|0.6221
70867955|NCT00934089|141221673|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.81||||0.3|TWO_SIDED|90.0|-1.11|4.74|||ANCOVA|||Change at Day 15 6 AM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||4.74|-1.11|0.3000
70867956|NCT00934089|141221673|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24||||0.9103|TWO_SIDED|90.0|-3.85|3.37|||ANCOVA|||Change at Day 15 8 AM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||3.37|-3.85|0.9103
70867957|NCT00934089|141221675|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|59.2|||<|0.001|TWO_SIDED|95.0|38.69|79.7|||Fisher Exact|||Photophobia: p-value was calculated using fisher exact test.||79.70|38.69|<0.001
70867958|NCT00934089|141221675|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-3.56||||0.612|TWO_SIDED|95.0|-14.8|7.68|||Fisher Exact|||Iritis: p-value was calculated using fisher exact test.||7.68|-14.80|0.612
71142318|NCT03192176|141778544|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|0.28||0.1671|TWO_SIDED|95.0|-0.16|0.92||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.92|-0.16|0.1671
71142319|NCT03192176|141778544|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.28||0.9462|TWO_SIDED|95.0|-0.57|0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.53|-0.57|0.9462
70867959|NCT00934089|141221677|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-52.42||||0.245|TWO_SIDED|90.0|-127.05|22.22|||ANCOVA|||Change at Day 13 8 AM study eye: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||22.22|-127.05|0.2450
70867960|NCT00934089|141221677|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|34.51||||0.3068|TWO_SIDED|90.0|-21.89|90.91|||ANCOVA|||Change at Day 13 8 AM fellow eye: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||90.91|-21.89|0.3068
70867961|NCT00934089|141221677|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|40.99||||0.2632|TWO_SIDED|90.0|-19.69|101.67|||ANCOVA|||Change at Day 35 8 AM study eye: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||101.67|-19.69|0.2632
70867962|NCT00934089|141221677|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.6||||0.8373|TWO_SIDED|90.0|-60.84|47.64|||ANCOVA|||Change at Day 35 8 AM fellow eye: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||47.64|-60.84|0.8373
70867963|NCT00680017|141221695|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||"P values were based on 2 sided tests. Tests resulting in P values less than or equal to 0.050 (when rounded) were reported as statistically significant. No adjustments made for multiple comparisons since only 1 primary efficacy endpoint comparison."|Wilcoxon rank-sum test|||The null hypothesis was that percent change in triglycerides (TG) from baseline to Week 8 in the ABT-335 45 mg plus rosuvastatin 5 mg treatment group is equal to percent change in TG from baseline to Week 8 in the rosuvastatin 5 mg plus placebo treatment group. A sample size of 140 participants per treatment group was used to provide 98% power to detect a difference between the combination therapy arm and the rosuvastatin monotherapy arm in the percent change from Baseline to Week 8 in TG.||||<0.001
70867964|NCT00680017|141221696|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||"P values were based on 2 sided tests. Tests resulting in P values less than or equal to 0.050 (when rounded) were reported as statistically significant. No adjustments made for multiple comparisons since only 1 secondary endpoint comparison."|ANCOVA|P-value obtained from an ANCOVA with corresponding baseline value as the covariate and an effect for treatment group.||The null hypothesis was that percent change in HDL-C from baseline to Week 8 in the ABT-335 45 mg plus rosuvastatin 5 mg treatment group is equal to percent change in HDL-C from baseline to Week 8 in the rosuvastatin 5 mg plus placebo treatment group. A sample size of 140 participants per treatment group was used to provide 82% power to detect a difference between the combination therapy arm and the rosuvastatin monotherapy arm in the percent change from Baseline to Week 8 in HDL-C.||||<0.001
70867965|NCT04572633|141221719|OTHER||Wilson Score|95.5|||||TWO_SIDED|95.0|83.72|100.0|||||Bootstrap sampling with replacement method to account for potential within-subject lesion correlations. Subject is the bootstrap sampling unit, 1,000,000 iterations for bootstrap resampling, and the bias-corrected and accelerated method was used.|||100|83.72|
70867966|NCT04572633|141221720|OTHER||Wilson Score|6.8|||||TWO_SIDED|95.0|2.35|18.23||||||||18.23|2.35|
71142320|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.0699|TWO_SIDED|95.0|-0.91|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||0.04|-0.91|0.0699
70867967|NCT03570697|141221802|SUPERIORITY||Treatment difference|21.2|STANDARD_ERROR_OF_MEAN|7.9||0.015|TWO_SIDED|95.0|4.7|37.7|||ANCOVA|||||37.7|4.7|0.015
70867968|NCT03570697|141221803|SUPERIORITY||Treatment difference|37.47|STANDARD_ERROR_OF_MEAN|17.04||0.041|TWO_SIDED|95.0|1.63|73.31|||ANCOVA|||||73.31|1.63|0.041
70867969|NCT03570697|141221804|SUPERIORITY||Treatment difference|32.51|STANDARD_ERROR_OF_MEAN|9.52||0.003|TWO_SIDED|95.0|12.67|52.35|||ANCOVA|||||52.35|12.67|0.003
70867970|NCT03570697|141221805|SUPERIORITY||Treatment difference|-26.0|STANDARD_ERROR_OF_MEAN|11.4||0.032|TWO_SIDED|95.0|-49.6|-2.4|||ANCOVA|||||-2.4|-49.6|0.032
70950650|NCT04624243|141402498|SUPERIORITY|It was hypothesized that MK-8189 16 mg is superior to placebo in reducing Week 6 PANSS PSS change from baseline|LS Mean Difference|-1.3||||0.096|TWO_SIDED|97.5|-3.1|0.5|||ANCOVA|||||0.5|-3.1|0.096
70867971|NCT03570697|141221806|SUPERIORITY||Treatment difference|16.0|STANDARD_ERROR_OF_MEAN|7.5||0.036|TWO_SIDED|95.0|1.1|31.0|||ANCOVA|||||31.0|1.1|0.036
70950651|NCT04624243|141402498|SUPERIORITY|It was hypothesized that MK-8189 24 mg is superior to placebo in reducing Week 6 PANSS PSS change from baseline|LS Mean Difference|-1.4||||0.094|TWO_SIDED|97.5|-3.2|0.5|||ANCOVA|||||0.5|-3.2|0.094
70950652|NCT04624243|141402499|SUPERIORITY|It was hypothesized that MK-8189 16 mg is superior to placebo in reducing Week 6 CGI-S change from baseline|LS Mean Difference|-0.2||||0.254|TWO_SIDED|97.5|-0.5|0.1|||ANCOVA|||||0.1|-0.5|0.254
70867972|NCT03570697|141221807|SUPERIORITY||Treatment difference|-30.0|STANDARD_ERROR_OF_MEAN|10.4||0.005|TWO_SIDED|95.0|-50.5|-9.5|||ANCOVA|||||-9.5|-50.5|0.005
70867973|NCT03570697|141221808|SUPERIORITY||Treatment difference|-2.43|STANDARD_ERROR_OF_MEAN|0.81||0.003|TWO_SIDED|95.0|-4.04|-0.82|||ANCOVA|||||-0.82|-4.04|0.003
70867974|NCT03948581|141221809|EQUIVALENCE|Geometric least-squares means (LSMs) were calculated by exponentiating the LSMs derived from analysis of variance (ANCOVA) with group, treatment, and injection site as fixed effects and weight as a continuous covariate. Confidence intervals (CIs) were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|0.9807|||||TWO_SIDED|90.0|0.9011|1.0675||||||||1.0675|0.9011|
70867975|NCT03948581|141221810|EQUIVALENCE|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with group, treatment, and injection site as fixed effects and weight as a continuous covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|0.9981|||||TWO_SIDED|90.0|0.9223|1.0801||||||||1.0801|0.9223|
70867976|NCT03948581|141221811|EQUIVALENCE|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with group, treatment, and injection site as fixed effects and weight as a continuous covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|1.0038|||||TWO_SIDED|90.0|0.9401|1.0719||||||||1.0719|0.9401|
70867977|NCT03068455|141221812|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.78|1.04|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab + Ipilimumab over Nivolumab|||1.04|0.78|
71142321|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.24||0.0056|TWO_SIDED|95.0|-1.15|-0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||-0.20|-1.15|0.0056
70950653|NCT04624243|141402499|SUPERIORITY|It was hypothesized that MK-8189 24 mg is superior to placebo in reducing Week 6 CGI-S change from baseline|LS Mean Difference|0.0||||0.959|TWO_SIDED|97.5|-0.3|0.3|||ANCOVA|||||0.3|-0.3|0.959
71142322|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.1117|TWO_SIDED|95.0|-0.86|0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||0.09|-0.86|0.1117
71142323|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.0265|TWO_SIDED|95.0|-1.02|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||-0.06|-1.02|0.0265
71142324|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.1119|TWO_SIDED|95.0|-0.86|0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||0.09|-0.86|0.1119
70867978|NCT03068455|141221813|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.75|1.14|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab + Ipilimumab over Nivolumab|||1.14|0.75|
71142325|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.7607|TWO_SIDED|95.0|-0.54|0.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||0.40|-0.54|0.7607
71142326|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.0437|TWO_SIDED|95.0|-0.97|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||-0.01|-0.97|0.0437
71142327|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.35||0.0211|TWO_SIDED|95.0|-1.51|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||-0.12|-1.51|0.0211
71142328|NCT03192176|141778544|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.35||0.0017|TWO_SIDED|95.0|-1.82|-0.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||-0.42|-1.82|0.0017
71142329|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.35||0.0598|TWO_SIDED|95.0|-1.37|0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||0.03|-1.37|0.0598
71142330|NCT03192176|141778544|SUPERIORITY||LSMean differencce|-0.5|STANDARD_ERROR_OF_MEAN|0.36||0.1573|TWO_SIDED|95.0|-1.21|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||0.20|-1.21|0.1573
71142331|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.36||0.7257|TWO_SIDED|95.0|-0.83|0.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||0.58|-0.83|0.7257
71142332|NCT03192176|141778544|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.35||0.9324|TWO_SIDED|95.0|-0.72|0.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||0.66|-0.72|0.9324
71142333|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.35||0.2172|TWO_SIDED|95.0|-1.14|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||0.26|-1.14|0.2172
71142334|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.23||0.0742|TWO_SIDED|95.0|-0.88|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Mean Score||0.04|-0.88|0.0742
71142335|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.24||0.0035|TWO_SIDED|95.0|-1.16|-0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Score||-0.23|-1.16|0.0035
71142336|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.0266|TWO_SIDED|95.0|-0.99|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Mean Score||-0.06|-0.99|0.0266
71142337|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.24||0.0124|TWO_SIDED|95.0|-1.06|-0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Mean Score||-0.13|-1.06|0.0124
71142338|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.4367|TWO_SIDED|95.0|-0.65|0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Mean Score||0.28|-0.65|0.4367
70867979|NCT03068455|141221814|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.8|1.32|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab + Ipilimumab over Nivolumab.|||1.32|0.80|
70867980|NCT03068455|141221815|SUPERIORITY||Hazard Ratio (HR)|1.22|||||TWO_SIDED|95.0|0.85|1.73|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab + Ipilimumab over Nivolumab.|||1.73|0.85|
71142339|NCT03192176|141778544|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.23||0.9318|TWO_SIDED|95.0|-0.48|0.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Mean Score||0.44|-0.48|0.9318
71142340|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.0714|TWO_SIDED|95.0|-0.89|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Mean Score||0.04|-0.89|0.0714
71142341|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.42||0.2027|TWO_SIDED|95.0|-1.35|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||0.29|-1.35|0.2027
71142342|NCT03192176|141778544|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.41||0.0013|TWO_SIDED|95.0|-2.16|-0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||-0.53|-2.16|0.0013
71142343|NCT03192176|141778544|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-2.53|-0.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||-0.87|-2.53|<0.0001
70867981|NCT03068455|141221816|SUPERIORITY|\< 1% Tumor PD-L1 Expression|Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.73|1.14|||||Unstratisfied HR, Nivolumab over Ipilimumab|||1.14|0.73|
70867982|NCT03068455|141221816|SUPERIORITY|\>= 1% Tumor PD-L1 Expression|Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.76|1.18|||||Unstratisfied HR, Nivolumab over ipilimumab|||1.18|0.76|
70950654|NCT04624243|141402503|SUPERIORITY|Estimated Treatment Difference vs Risperidone|LS Mean Difference|-8.5|||<|0.001|TWO_SIDED|97.5|-10.4|-6.5|||ANCOVA|Covariates were treatment, stratum (US Black, US-Non-Black, Other), gender (male, female), and with baseline value, the duration of illness and age||||-6.5|-10.4|<0.001
70867983|NCT03068455|141221816|SUPERIORITY|\>= 5% Tumor PD-L1 Expression|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.71|1.34|||||Unstratisfied HR, Nivolumab over ipilimumab|||1.34|0.71|
70867984|NCT03068455|141221816|SUPERIORITY|\< 5% Tumor PD-L1 Expression|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.77|1.1|||||Unstratisfied HR, Nivolumab over ipilimumab|||1.10|0.77|
70867985|NCT03068455|141221816|SUPERIORITY|Non-quantifiable Tumor PD-L1 Expression|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.38|1.51|||||Unstratisfied HR, Nivolumab over ipilimumab|||1.51|0.38|
70867986|NCT04472429|141221838|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0006|TWO_SIDED|95.0|0.47|0.84||tested at the 1-sided 2.5% level|stratified log-rank test||A stratified Cox regression with Efron's method for tie handling was used to estimate the hazard ratio.|||0.84|0.47|0.0006
70867987|NCT01172522|141221851|SUPERIORITY_OR_OTHER||Other|0.0|||=|1|TWO_SIDED||||||Chi-squared||P values above 0.05 is considered statistically insignificant in this study.|||||=1
70867988|NCT03344796|141221945|SUPERIORITY||||||<|0.01|||||||Chi-squared|||||||<0.01
70867989|NCT03344796|141221946|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||||||<0.001
70867990|NCT03344796|141221947|SUPERIORITY||||||<|0.01|||||||Chi-squared|||||||<0.01
70867991|NCT03344796|141221948|SUPERIORITY||||||<|0.1|||||||Chi-squared|||Knowledge of sun protection score at baseline compared with score after completion of the arm. The hypothesis is that the focus group, usability test and structured interviews arms will not have significant change in knowledge. It is expected that cohort studies 1 and 2 will have significant change in knowledge of sun protection.||||< 0.1
70867992|NCT04547712|141221963|SUPERIORITY||Proportion expressed as a percentage|78.9|||||ONE_SIDED|97.5|59.4||||||The confidence interval lower limit was above the performance goal of 50%, the primary objective was met.|"Null Hypothesis: The proportion of subjects with On time without troublesome dyskinesia during aDBS single threshold mode Evaluation Period exceeding threshold \<= 50%; Alternative Hypothesis: The proportion of subjects with On time without troublesome dyskinesia during aDBS single threshold mode Evaluation Period exceeding threshold \> 50%"|||59.4|
70867993|NCT04547712|141221963|SUPERIORITY||Proportion expressed as a percentage|91.0|||||ONE_SIDED|97.5|75.6||||||The confidence interval lower limit was above the performance goal of 50%, the primary objective was met.|"Null Hypothesis: The proportion of subjects with On time without troublesome dyskinesia during aDBS dual threshold mode Evaluation Period exceeding threshold \<= 50%; Alternative Hypothesis: The proportion of subjects with On time without troublesome dyskinesia during aDBS dual threshold mode Evaluation Period exceeding threshold \> 50%"|||75.6|
70867994|NCT04547712|141221964|SUPERIORITY|||||||0.012||||||Nominal p-value is provided.|t-test, 2 sided|||Null Hypothesis: Mean Difference between aDBS single threshold (Evaluation Phase) minus cDBS (Baseline Phase) for TEED \>= 0; Alternative Hypothesis: Mean Difference between aDBS single threshold (Evaluation Phase) minus cDBS (Baseline Phase) for TEED \< 0||||0.0120
70867995|NCT04547712|141221964|SUPERIORITY|||||||0.0491||||||Nominal p-value is provided.|t-test, 2 sided|||Null Hypothesis: Mean Difference between aDBS dual threshold (Evaluation Phase) minus cDBS (Baseline Phase) for TEED \>= 0; Alternative Hypothesis: Mean Difference between aDBS dual threshold (Evaluation Phase) minus cDBS (Baseline Phase) for TEED \< 0||||0.0491
70867996|NCT00594659|141221966|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||accelerated bootstrapping|||Pairwise comparison; non-parametric tests performed because of non-normal distribution||||<0.05
70867997|NCT00594659|141221966|SUPERIORITY_OR_OTHER||||||<|0.05|||||||accelerated bootstrapping|||pairwise comparison; non-parametric analysis||||< .05
70867998|NCT00594659|141221966|SUPERIORITY_OR_OTHER||||||>|0.05|||||||accelerated bootstrapping|||nonparametric pairwise comparison; non-normal distribution||||> 0.05
70950655|NCT04624243|141402503|SUPERIORITY|Estimated Treatment Difference vs Risperidone|LS Mean Difference|-7.3|||<|0.001|TWO_SIDED|97.5|-9.3|-5.2|||ANCOVA|Covariates were treatment, stratum (US Black, US-Non-Black, Other), gender (male, female), and with baseline value, the duration of illness and age||||-5.2|-9.3|<0.001
70867999|NCT00594659|141221967|SUPERIORITY_OR_OTHER||Slope|3.11|STANDARD_ERROR_OF_MEAN|0.69|<|0.05|TWO_SIDED||||||piecewise mixed model with logit link an|Performed across all assessments.|Slope and p-value above are for group 1: baseline to ETX. Group 3 vs. Group 1 baseline to ETX slope, p \< 0.05. All other pairwise comparisons p \> 0.05.|pairwise comparisons among groups across 4 follow-up timepoints||||< 0.05
71142344|NCT03192176|141778544|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-2.83|-1.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||-1.16|-2.83|<0.0001
70950656|NCT04624243|141402504|SUPERIORITY|Estimated Treatment Difference vs Risperidone|LS Mean Difference|-6.0|||<|0.001|TWO_SIDED|97.5|-7.4|-4.6|||ANCOVA|Covariates were treatment, stratum (US Black, US-Non-Black, Other), gender (male, female), and with baseline value, the duration of illness and age||||-4.6|-7.4|<0.001
71142345|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.42||0.3791|TWO_SIDED|95.0|-1.19|0.45||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||0.45|-1.19|0.3791
71142346|NCT03192176|141778544|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.42||0.0211|TWO_SIDED|95.0|-1.78|-0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||-0.15|-1.78|0.0211
71142347|NCT03192176|141778544|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.42||0.0021|TWO_SIDED|95.0|-2.1|-0.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||-0.47|-2.10|0.0021
71142348|NCT03192176|141778544|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.889|TWO_SIDED|95.0|-0.55|0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 8: Psychological Mean Score||0.48|-0.55|0.8890
71142349|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.26||0.5568|TWO_SIDED|95.0|-0.67|0.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Mean Score||0.36|-0.67|0.5568
71142350|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.27||0.3989|TWO_SIDED|95.0|-0.75|0.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Mean Score||0.30|-0.75|0.3989
71142351|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.27||0.6094|TWO_SIDED|95.0|-0.66|0.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Mean Score||0.39|-0.66|0.6094
71142352|NCT03192176|141778544|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.26||0.5229|TWO_SIDED|95.0|-0.35|0.69||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Mean Score||0.69|-0.35|0.5229
71142353|NCT03192176|141778544|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.26||0.4409|TWO_SIDED|95.0|-0.31|0.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Mean Score||0.72|-0.31|0.4409
71142354|NCT03192176|141778544|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.26||0.8062|TWO_SIDED|95.0|-0.45|0.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Mean Score||0.58|-0.45|0.8062
71142355|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.25||0.3663|TWO_SIDED|95.0|-0.71|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Mean Score||0.26|-0.71|0.3663
71142356|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.25||0.0424|TWO_SIDED|95.0|-0.99|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Mean Score||-0.02|-0.99|0.0424
71142357|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.25||0.1597|TWO_SIDED|95.0|-0.85|0.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Mean Score||0.14|-0.85|0.1597
71142358|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.25||0.0595|TWO_SIDED|95.0|-0.97|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Mean Score||0.02|-0.97|0.0595
71142359|NCT03192176|141778544|SUPERIORITY||LSMean differnce|-0.3|STANDARD_ERROR_OF_MEAN|0.25||0.2162|TWO_SIDED|95.0|-0.8|0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||0.18|-0.80|0.2162
71142360|NCT03192176|141778544|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.9833|TWO_SIDED|95.0|-0.49|0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Mean Score||0.48|-0.49|0.9833
71142361|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.25||0.2034|TWO_SIDED|95.0|-0.81|0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Mean Score||0.17|-0.81|0.2034
71142362|NCT03192176|141778544|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.35||0.9576|TWO_SIDED|95.0|-0.7|0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||0.67|-0.70|0.9576
71142363|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.35||0.041|TWO_SIDED|95.0|-1.4|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||-0.03|-1.40|0.0410
71142364|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.35||0.3961|TWO_SIDED|95.0|-1.0|0.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||0.40|-1.00|0.3961
71142365|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.36||0.5012|TWO_SIDED|95.0|-0.94|0.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||0.46|-0.94|0.5012
71142366|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.35||0.2592|TWO_SIDED|95.0|-1.1|0.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||0.30|-1.10|0.2592
71142367|NCT03192176|141778544|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.35||0.6141|TWO_SIDED|95.0|-0.51|0.86||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||0.86|-0.51|0.6141
71142368|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.35||0.439|TWO_SIDED|95.0|-0.95|0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||0.41|-0.95|0.4390
71142369|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.23||0.4521|TWO_SIDED|95.0|-0.64|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Overall Mean Score||0.29|-0.64|0.4521
71142370|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.23||0.0257|TWO_SIDED|95.0|-0.99|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Overall Mean Score||-0.06|-0.99|0.0257
71142371|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.0564|TWO_SIDED|95.0|-0.93|0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Overall Mean Score||0.01|-0.93|0.0564
70872223|NCT00378378|141229701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.603||95.0|||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for baseline to endpoint.||||0.603
71142372|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.0293|TWO_SIDED|95.0|-0.99|-0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 8: Overall Mean Score||-0.05|-0.99|0.0293
71142373|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.3742|TWO_SIDED|95.0|-0.68|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Overall Mean Score||0.26|-0.68|0.3742
71142374|NCT03192176|141778544|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.23||0.9106|TWO_SIDED|95.0|-0.49|0.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Overall Mean Score||0.44|-0.49|0.9106
71142375|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.23||0.1844|TWO_SIDED|95.0|-0.78|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Overall Mean SCore||0.15|-0.78|0.1844
71142376|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.41||0.0287|TWO_SIDED|95.0|-1.69|-0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||-0.09|-1.69|0.0287
71142377|NCT03192176|141778544|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.41||0.0028|TWO_SIDED|95.0|-2.05|-0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||-0.43|-2.05|0.0028
71142378|NCT03192176|141778544|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.42||0.0004|TWO_SIDED|95.0|-2.32|-0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||-0.67|-2.32|0.0004
71142379|NCT03192176|141778544|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-2.87|-1.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||-1.22|-2.87|<0.0001
71142380|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.42||0.1826|TWO_SIDED|95.0|-1.38|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||0.26|-1.38|0.1826
71142381|NCT03192176|141778544|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.41||0.0178|TWO_SIDED|95.0|-1.79|-0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||-0.17|-1.79|0.0178
71142382|NCT03192176|141778544|SUPERIORITY||LSMean differnce|-1.2|STANDARD_ERROR_OF_MEAN|0.41||0.0025|TWO_SIDED|95.0|-2.06|-0.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||-0.44|-2.06|0.0025
71142383|NCT03192176|141778544|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.27||0.9163|TWO_SIDED|95.0|-0.55|0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.50|-0.55|0.9163
70868034|NCT04997304|141222080|OTHER|Test of paired differences||||||0.0019|||||||t-test, 2 sided|Paired t-test||This analysis applies only to comparison of baseline and exacerbation for AirDuo||||0.0019
70868035|NCT04997304|141222080|OTHER|Test of paired differences||||||0.002|||||||t-test, 2 sided|Paired t-test||This analysis applies only to comparison of baseline and exacerbation for ProAir||||0.0020
70868036|NCT04997304|141222081|OTHER|Test of paired differences||||||0.0008|||||||t-test, 2 sided|Paired t-test||This analysis applies only to comparison of baseline and exacerbation for AirDuo||||0.0008
70868037|NCT04997304|141222081|OTHER|Test of paired differences||||||0.0003|||||||t-test, 2 sided|Paired t-test||This analysis applies only to comparison of baseline and exacerbation for ProAir||||0.0003
70868038|NCT04997304|141222082|OTHER|Test of paired differences||||||0.04|||||||t-test, 2 sided|Paired t-test||This analysis applies only to comparison of baseline and exacerbation for AirDuo||||0.04
70868039|NCT04997304|141222082|OTHER|Test of paired differences||||||0.0965|||||||t-test, 2 sided|Paired t-test||This analysis applies only to comparison of baseline and exacerbation for ProAir||||0.0965
70868040|NCT06934993|141222095|SUPERIORITY||||||<|0.001||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||<0.001
70872224|NCT00378378|141229701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.193||95.0|||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for baseline to endpoint.||||0.193
70868041|NCT06934993|141222096|SUPERIORITY|||||||0.001||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In all cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.001
70868042|NCT06934993|141222096|SUPERIORITY|||||||0.096||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.096
70872225|NCT00407797|141229702|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Percent change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||<.0001
70868043|NCT06934993|141222096|SUPERIORITY||||||<|0.001||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||<0.001
70868044|NCT06934993|141222097|SUPERIORITY|||||||0.001||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.001
70868045|NCT06934993|141222097|SUPERIORITY|||||||0.096||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.096
70868046|NCT06934993|141222098|SUPERIORITY|||||||0.04||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.04
70868047|NCT06934993|141222098|SUPERIORITY|||||||0.679||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.679
70868048|NCT06934993|141222098|SUPERIORITY|||||||0.011||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.011
70868049|NCT04092582|141222099|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.6835|TWO_SIDED|95.0|0.55|1.47|||Regression, Cox|||||1.47|0.55|0.6835
70868050|NCT04092582|141222100|SUPERIORITY||Rate Ratio|1.0989||||0.7648|TWO_SIDED|95.0|0.5925|2.0381|||Poisson regression|||||2.0381|0.5925|0.7648
70868051|NCT04092582|141222101|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.5248|TWO_SIDED|95.0|0.43|1.54|||Regression, Cox|||||1.54|0.43|0.5248
70868052|NCT04092582|141222102|SUPERIORITY|||||||0.125|||||||Mixed model for repeated measures (MMRM)|||||||0.1250
70868053|NCT04092582|141222103|SUPERIORITY|||||||0.2249|||||||Mixed model for repeated measures (MMRM)|||||||0.2249
70868054|NCT04092582|141222104|SUPERIORITY|||||||0.9693|||||||Mixed model for repeated measures (MMRM)|||||||0.9693
70868055|NCT04092582|141222105|SUPERIORITY|||||||0.9855|||||||Mixed model for repeated measures (MMRM)|||||||0.9855
70868056|NCT00283400|141222152|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.05|||<|0.05|TWO_SIDED|95.0|0.65|14.1|||Mixed Models Analysis|Post-hoc comparison of outcomes in dosage tier 1 vs dosage tier 2.||||14.1|0.65|<0.05
70868057|NCT01948947|141222173|OTHER||||||<|0.0001|||||||ANOVA|||Change from Baseline to 1-Week Post-Treatment||||<0.0001
70868058|NCT01948947|141222173|OTHER||||||<|0.001|||||||ANOVA|||Change from Baseline to 1-Month Post-Treatment||||<0.001
70868059|NCT01948947|141222174|OTHER||||||<|0.001||||||Change from Baseline to 1-Week post-treatment|ANOVA|||||||<0.001
70868060|NCT01948947|141222174|OTHER||||||<|0.01||||||Change from Baseline to 1-Month post-treatment|ANOVA|||||||<0.01
70868061|NCT01948947|141222175|OTHER|||||||0.009|||||||ANOVA|||||||0.009
70868062|NCT01948947|141222175|OTHER||||||<|0.01||||||Change in Baseline to 1-month post-treatment|ANOVA|||||||<0.01
70868063|NCT01948947|141222176|OTHER||||||=|0.033|||||||ANOVA|||||||=0.033
70868064|NCT05096221|141222177|SUPERIORITY||Least squares mean change difference|0.65|STANDARD_ERROR_OF_MEAN|0.55||0.2441|TWO_SIDED|95.0|-0.45|1.74|||Mixed model of repeated measures|||||1.74|-0.45|0.2441
70868065|NCT05096221|141222178|OTHER||||||<|0.0001|||||||Re-randomization test|||||||< 0.0001
70868066|NCT05096221|141222179|SUPERIORITY||Least squares mean change difference|-0.64|STANDARD_ERROR_OF_MEAN|0.21||0.0025|TWO_SIDED|95.0|-1.06|-0.23|||Mixed model of repeated measures|||||-0.23|-1.06|0.0025
70868067|NCT05096221|141222180|SUPERIORITY||Least squares mean change difference|-0.42|STANDARD_ERROR_OF_MEAN|0.15||0.0048|TWO_SIDED|95.0|-0.71|-0.13|||Mixed model of repeated measures|||||-0.13|-0.71|0.0048
70868068|NCT05096221|141222181|SUPERIORITY||Least squares mean change difference|-3.29|STANDARD_ERROR_OF_MEAN|2.52||0.1942|TWO_SIDED|95.0|-8.28|1.7|||Mixed model of repeated measures|||||1.70|-8.28|0.1942
70868069|NCT05096221|141222182|SUPERIORITY||Least squares mean change difference|-0.36|STANDARD_ERROR_OF_MEAN|0.18||0.0412|TWO_SIDED|95.0|-0.71|-0.01|||Mixed model of repeated measures|||||-0.01|-0.71|0.0412
70868070|NCT05096221|141222183|SUPERIORITY||Least squares mean change difference|0.1|STANDARD_ERROR_OF_MEAN|0.05||0.0402|TWO_SIDED|95.0|0.0|0.19|||Mixed model of repeated measures|||||0.19|0.00|0.0402
70868071|NCT05096221|141222184|SUPERIORITY||Least squares mean change difference|0.05|STANDARD_ERROR_OF_MEAN|0.07||0.4272|TWO_SIDED|95.0|-0.08|0.19|||Mixed model of repeated measures|||||0.19|-0.08|0.4272
70868072|NCT05096221|141222185|SUPERIORITY||Least squares mean change difference|-0.04|STANDARD_ERROR_OF_MEAN|0.1||0.7324|TWO_SIDED|95.0|-0.24|0.17|||Mixed model of repeated measures|||||0.17|-0.24|0.7324
70868073|NCT05096221|141222186|SUPERIORITY||Least squares mean change difference|0.19|STANDARD_ERROR_OF_MEAN|0.44||0.6554|TWO_SIDED|95.0|-0.67|1.06|||Mixed model of repeated measures|||||1.06|-0.67|0.6554
70868074|NCT03719612|141222212|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.38|STANDARD_DEVIATION|4.947||0.358|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.358
70868075|NCT03719612|141222212|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.12|STANDARD_DEVIATION|5.699||0.804|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.804
70868076|NCT03719612|141222212|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.33|STANDARD_DEVIATION|4.412||0.371|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.371
70872226|NCT00407797|141229703|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<.0001
71142384|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.27||0.1597|TWO_SIDED|95.0|-0.92|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.15|-0.92|0.1597
71142385|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.4871|TWO_SIDED|95.0|-0.74|0.35||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.35|-0.74|0.4871
71142386|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.5401|TWO_SIDED|95.0|-0.72|0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.38|-0.72|0.5401
71142387|NCT03192176|141778544|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.28||0.3788|TWO_SIDED|95.0|-0.3|0.79||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.79|-0.30|0.3788
71142388|NCT03192176|141778544|SUPERIORITY||0.28|0.2|STANDARD_ERROR_OF_MEAN|0.27||0.4541|TWO_SIDED|95.0|-0.33|0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.74|-0.33|0.4541
71142389|NCT03192176|141778544|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.27||0.9233|TWO_SIDED|95.0|-0.51|0.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.56|-0.51|0.9233
71142390|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.6043|TWO_SIDED|95.0|-0.61|0.35||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.35|-0.61|0.6043
71142391|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.25||0.1781|TWO_SIDED|95.0|-0.82|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.15|-0.82|0.1781
71142392|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.25||0.5221|TWO_SIDED|95.0|-0.66|0.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.34|-0.66|0.5221
71142393|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.25||0.4744|TWO_SIDED|95.0|-0.68|0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.32|-0.68|0.4744
71142394|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.25||0.5167|TWO_SIDED|95.0|-0.66|0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.33|-0.66|0.5167
71142395|NCT03192176|141778544|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.25||0.3441|TWO_SIDED|95.0|-0.25|0.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.72|-0.25|0.3441
71142396|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.25||0.5362|TWO_SIDED|95.0|-0.64|0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.33|-0.64|0.5362
71142397|NCT03192176|141778544|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.38||0.9349|TWO_SIDED|95.0|-0.78|0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||0.71|-0.78|0.9349
71142398|NCT03192176|141778544|SUPERIORITY||LSMean differencce|-1.0|STANDARD_ERROR_OF_MEAN|0.39||0.0084|TWO_SIDED|95.0|-1.78|-0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||-0.26|-1.78|0.0084
71142399|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.39||0.1212|TWO_SIDED|95.0|-1.38|0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||0.16|-1.38|0.1212
71142400|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.39||0.7709|TWO_SIDED|95.0|-0.89|0.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||0.66|-0.89|0.7709
70868077|NCT03719612|141222213|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-1.28|STANDARD_DEVIATION|3.952||0.03|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.030
70868078|NCT03719612|141222213|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.66|STANDARD_DEVIATION|4.466||0.312|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.312
70868079|NCT03719612|141222213|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.65|STANDARD_DEVIATION|4.725||0.347|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.347
70868080|NCT03719612|141222214|OTHER||Intra-class Correlation Coefficient|0.984|||||TWO_SIDED|95.0|0.977|0.988||||||Inter-Reader Variability Echo Enhanced||0.988|0.977|
70868081|NCT03719612|141222214|OTHER||Intra-class Correlation Coefficient|0.953|||||TWO_SIDED|95.0|0.936|0.966||||||Inter-Reader Variability Echo Unenhanced||0.966|0.936|
70868082|NCT03719612|141222214|OTHER||Intra-class Correlation Coefficient|0.97|||||TWO_SIDED|95.0|0.958|0.978||||||Inter-Reader Variability Echo Enhanced||0.978|0.958|
70950657|NCT04624243|141402504|SUPERIORITY|Estimated Treatment Difference vs Risperidone|LS Mean Difference|-5.6|||<|0.001|TWO_SIDED|97.5|-7.0|-4.2|||ANCOVA|Covariates were treatment, stratum (US Black, US-Non-Black, Other), gender (male, female), and with baseline value, the duration of illness and age||||-4.2|-7.0|<0.001
70868083|NCT03719612|141222214|OTHER||Intra-class Correlation Coefficient|0.944|||||TWO_SIDED|95.0|0.923|0.959||||||Inter-Reader Variability Echo Unenhanced||0.959|0.923|
70868084|NCT03719612|141222214|OTHER||Intra-class Correlation Coefficient|0.961|||||TWO_SIDED|95.0|0.947|0.972||||||Inter-Reader Variability Echo Enhanced||0.972|0.947|
70868085|NCT03719612|141222214|OTHER||Intra-class Correlation Coefficient|0.942|||||TWO_SIDED|95.0|0.92|0.958||||||Inter-Reader Variability Echo Unenhanced||0.958|0.920|
70868086|NCT03719612|141222215|OTHER||Intra-class Correlation Coefficient|0.984|||||TWO_SIDED|95.0|0.978|0.988||||||Inter-Reader Variability End Diastolic Echo Enhanced||0.988|0.978|
70868087|NCT03719612|141222215|OTHER||Intra-class Correlation Coefficient|0.976|||||TWO_SIDED|95.0|0.967|0.983||||||Inter-Reader Variability End Diastolic Echo Unenhanced||0.983|0.967|
70868088|NCT03719612|141222215|OTHER||Intra-class Correlation Coefficient|0.973|||||TWO_SIDED|95.0|0.963|0.981||||||Inter-Reader Variability End Diastolic Echo Enhanced||0.981|0.963|
70868089|NCT03719612|141222215|OTHER||Intra-class Correlation Coefficient|0.935|||||TWO_SIDED|95.0|0.91|0.952||||||Inter-Reader Variability End Diastolic Echo Unenhanced||0.952|0.910|
70868090|NCT03719612|141222215|OTHER||Intra-class Correlation Coefficient|0.973|||||TWO_SIDED|95.0|0.962|0.98||||||Inter-Reader Variability End Diastolic Echo Enhanced||0.980|0.962|
70868091|NCT03719612|141222215|OTHER||Intra-class Correlation Coefficient|0.924|||||TWO_SIDED|95.0|0.896|0.945||||||Inter-Reader Variability End Diastolic Echo Unenhanced||0.945|0.896|
70868092|NCT03719612|141222215|OTHER||Intra-class Correlation Coefficient|0.989|||||TWO_SIDED|95.0|0.984|0.992||||||Inter-Reader Variability End Systolic Echo Enhanced||0.992|0.984|
70868093|NCT03719612|141222215|OTHER||Intra-class Correlation Coefficient|0.983|||||TWO_SIDED|95.0|0.977|0.988||||||Inter-Reader Variability End Systolic Echo Unenhanced||0.988|0.977|
70868094|NCT03719612|141222215|OTHER||Intra-class Correlation Coefficient|0.984|||||TWO_SIDED|95.0|0.978|0.989||||||Inter-Reader Variability End Systolic Echo Enhanced||0.989|0.978|
70868095|NCT03719612|141222215|OTHER||Intra-class Correlation Coefficient|0.948|||||TWO_SIDED|95.0|0.928|0.962||||||Inter-Reader Variability End Systolic Echo Unenhanced||0.962|0.928|
70868096|NCT03719612|141222215|OTHER||Intra-class Correlation Coefficient|0.978|||||TWO_SIDED|95.0|0.969|0.984||||||Inter-Reader Variability End Systolic Echo Enhanced||0.984|0.969|
70868097|NCT03719612|141222215|OTHER||Intra-class Correlation Coefficient|0.942|||||TWO_SIDED|95.0|0.92|0.958||||||Inter-Reader Variability End Systolic Echo Unenhanced||0.958|0.920|
70868098|NCT03719612|141222216|OTHER||Intra-class Correlation Coefficient|0.975|||||TWO_SIDED|95.0|0.956|0.986||||||Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms||0.986|0.956|
70868099|NCT03719612|141222216|OTHER||Intra-class Correlation Coefficient|0.936|||||TWO_SIDED|95.0|0.888|0.963||||||Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms||0.963|0.888|
70868100|NCT03719612|141222216|OTHER||Intra-class Correlation Coefficient|0.961|||||TWO_SIDED|95.0|0.931|0.978||||||Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms||0.978|0.931|
70868101|NCT03719612|141222216|OTHER||Intra-class Correlation Coefficient|0.921|||||TWO_SIDED|95.0|0.864|0.955||||||Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms||0.955|0.864|
70868102|NCT03719612|141222216|OTHER||Intra-class Correlation Coefficient|0.947|||||TWO_SIDED|95.0|0.907|0.97||||||Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms||0.970|0.907|
70868103|NCT03719612|141222216|OTHER||Intra-class Correlation Coefficient|0.903|||||TWO_SIDED|95.0|0.834|0.945||||||Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms||0.945|0.834|
70868104|NCT03719612|141222217|OTHER||Intra-class Correlation Coefficient|0.984|||||TWO_SIDED|95.0|0.971|0.991||||||Inter-Reader Variability End Diastolic Echo Enhanced Sub-Optimal Echocardiograms||0.991|0.971|
70868105|NCT03719612|141222217|OTHER||Intra-class Correlation Coefficient|0.975|||||TWO_SIDED|95.0|0.956|0.986||||||Inter-Reader Variability End Diastolic Echo Unenhanced Sub-Optimal Echocardiograms||0.986|0.956|
70868106|NCT03719612|141222217|OTHER||Intra-class Correlation Coefficient|0.977|||||TWO_SIDED|95.0|0.959|0.987||||||Inter-Reader Variability End Diastolic Echo Enhanced Sub-Optimal Echocardiograms||0.987|0.959|
70868107|NCT03719612|141222217|OTHER||Intra-class Correlation Coefficient|0.94|||||TWO_SIDED|95.0|0.896|0.966||||||Inter-Reader Variability End Diastolic Echo Unenhanced Sub-Optimal Echocardiograms||0.966|0.896|
70868108|NCT03719612|141222217|OTHER||Intra-class Correlation Coefficient|0.977|||||TWO_SIDED|95.0|0.959|0.987||||||Inter-Reader Variability End Diastolic Echo Enhanced Sub-Optimal Echocardiograms||0.987|0.959|
70868109|NCT03719612|141222217|OTHER||Intra-class Correlation Coefficient|0.923|||||TWO_SIDED|95.0|0.866|0.956||||||Inter-Reader Variability End Diastolic Echo Unenhanced Sub-Optimal Echocardiograms||0.956|0.866|
70868110|NCT03719612|141222217|OTHER||Intra-class Correlation Coefficient|0.99|||||TWO_SIDED|95.0|0.982|0.994||||||Inter-Reader Variability End Systolic Echo Enhanced Sub-Optimal Echocardiograms||0.994|0.982|
70868111|NCT03719612|141222217|OTHER||Intra-class Correlation Coefficient|0.976|||||TWO_SIDED|95.0|0.957|0.986||||||Inter-Reader Variability End Systolic Echo Unenhanced Sub-Optimal Echocardiograms||0.986|0.957|
70868112|NCT03719612|141222217|OTHER||Intra-class Correlation Coefficient|0.985|||||TWO_SIDED|95.0|0.973|0.991||||||Inter-Reader Variability End Systolic Echo Enhanced Sub-Optimal Echocardiograms||0.991|0.973|
70950658|NCT04896008|141402526|SUPERIORITY||Hazard Ratio (HR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.13|0.43||One-sided p-value based on log-rank test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Log Rank||HR and associated 95% confidence interval were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||0.43|0.13|<0.0001
70950659|NCT04896008|141402527|SUPERIORITY||Hazard Ratio (HR)|0.42||||0.0313|TWO_SIDED|95.0|0.17|1.07||One-sided p-value based on log-rank test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||1.07|0.17|0.0313
71142401|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.1667|TWO_SIDED|95.0|-1.33|0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||0.23|-1.33|0.1667
70950660|NCT04896008|141402528|SUPERIORITY||Hazard Ratio (HR)|0.34||||0.0039|TWO_SIDED|95.0|0.15|0.78||One-sided p-value based on log-rank test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||0.78|0.15|0.0039
71142402|NCT03192176|141778544|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.38||0.9213|TWO_SIDED|95.0|-0.72|0.79||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||0.79|-0.72|0.9213
71142403|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.38||0.2315|TWO_SIDED|95.0|-1.21|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||0.29|-1.21|0.2315
71142404|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.23||0.4731|TWO_SIDED|95.0|-0.63|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||0.29|-0.63|0.4731
71142405|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.031|TWO_SIDED|95.0|-0.98|-0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||-0.05|-0.98|0.0310
71142406|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.132|TWO_SIDED|95.0|-0.84|0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||0.11|-0.84|0.1320
71142407|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.1212|TWO_SIDED|95.0|-0.85|0.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||0.10|-0.85|0.1212
71142408|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.5689|TWO_SIDED|95.0|-0.62|0.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||0.34|-0.62|0.5689
71142409|NCT03192176|141778544|SUPERIORITY||0.1|0.1|STANDARD_ERROR_OF_MEAN|0.24||0.734|TWO_SIDED|95.0|-0.39|0.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||0.55|-0.39|0.7340
71142410|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.24||0.2704|TWO_SIDED|95.0|-0.73|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||0.20|-0.73|0.2704
71142411|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.48||0.561|TWO_SIDED|95.0|-1.24|0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Mean Score||0.67|-1.24|0.5610
71142412|NCT03192176|141778544|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.49||0.7966|TWO_SIDED|95.0|-0.83|1.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Mean Score||1.09|-0.83|0.7966
71142413|NCT03192176|141778544|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|0.5||0.3965|TWO_SIDED|95.0|-0.56|1.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Mean Score||1.40|-0.56|0.3965
71142414|NCT03192176|141778544|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.5||0.8189|TWO_SIDED|95.0|-0.87|1.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Mean Score||1.10|-0.87|0.8189
71142415|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.5||0.5693|TWO_SIDED|95.0|-1.27|0.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||0.70|-1.27|0.5693
70868113|NCT03719612|141222217|OTHER||Intra-class Correlation Coefficient|0.929|||||TWO_SIDED|95.0|0.876|0.959||||||Inter-Reader Variability End Systolic Echo Unenhanced Sub-Optimal Echocardiograms||0.959|0.876|
71142416|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.49||0.5217|TWO_SIDED|95.0|-1.29|0.65||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Mean Score||0.65|-1.29|0.5217
71142417|NCT03192176|141778544|SUPERIORITY||LSMean difference|0.5|STANDARD_ERROR_OF_MEAN|0.49||0.2988|TWO_SIDED|95.0|-0.46|1.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Mean Score||1.48|-0.46|0.2988
71142418|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.31||0.7957|TWO_SIDED|95.0|-0.69|0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.53|-0.69|0.7957
71142419|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.31||0.254|TWO_SIDED|95.0|-0.97|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.26|-0.97|0.2540
71142420|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.32||0.6956|TWO_SIDED|95.0|-0.75|0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.50|-0.75|0.6956
71142421|NCT03192176|141778544|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.32||0.8694|TWO_SIDED|95.0|-0.57|0.68||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.68|-0.57|0.8694
71142422|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.32||0.5047|TWO_SIDED|95.0|-0.84|0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.41|-0.84|0.5047
71142423|NCT03192176|141778544|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.31||0.7515|TWO_SIDED|95.0|-0.52|0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.71|-0.52|0.7515
71142424|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.31||0.7818|TWO_SIDED|95.0|-0.7|0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.53|-0.70|0.7818
71142425|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.577|TWO_SIDED|95.0|-0.65|0.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.36|-0.65|0.5770
71142426|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.26||0.1893|TWO_SIDED|95.0|-0.85|0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.17|-0.85|0.1893
71142427|NCT03192176|141778544|SUPERIORITY||LSMean difference|0.3|STANDARD_ERROR_OF_MEAN|0.26||0.2997|TWO_SIDED|95.0|-0.25|0.79||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.79|-0.25|0.2997
71142428|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.7529|TWO_SIDED|95.0|-0.6|0.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.44|-0.60|0.7529
71142429|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.26||0.4173|TWO_SIDED|95.0|-0.73|0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.31|-0.73|0.4173
71142430|NCT03192176|141778544|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.26||0.4944|TWO_SIDED|95.0|-0.34|0.69||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.69|-0.34|0.4944
71142431|NCT03192176|141778544|SUPERIORITY||LSMean differencce|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.9231|TWO_SIDED|95.0|-0.54|0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.49|-0.54|0.9231
70868114|NCT03719612|141222217|OTHER||Intra-class Correlation Coefficient|0.981|||||TWO_SIDED|95.0|0.966|0.989||||||Inter-Reader Variability End Systolic Echo Enhanced Sub-Optimal Echocardiograms||0.989|0.966|
70868115|NCT03719612|141222217|OTHER||Intra-class Correlation Coefficient|0.916|||||TWO_SIDED|95.0|0.855|0.952||||||Inter-Reader Variability End Systolic Echo Unenhanced Sub-Optimal Echocardiograms||0.952|0.855|
70868116|NCT02284516|141222257|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|7.16|STANDARD_ERROR_OF_MEAN|2.096|=|0.0007|TWO_SIDED|95.0|3.04|11.28||The primary analysis was performed using a stratified 2-sample t-test (that is, analysis of variance \[ANOVA\]).|ANOVA|||||11.28|3.04|=0.0007
70868117|NCT02284516|141222258|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|7.85|STANDARD_ERROR_OF_MEAN|1.792|<|0.0001|TWO_SIDED|95.0|4.33|11.37||The primary analysis was performed using a stratified 2-sample t-test (that is, analysis of variance \[ANOVA\]).|ANOVA|||Baseline and Day 14||11.37|4.33|<0.0001
70868118|NCT02284516|141222258|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|9.32|STANDARD_ERROR_OF_MEAN|1.976|<|0.0001|TWO_SIDED|95.0|5.44|13.2||The primary analysis was performed using a stratified 2-sample t-test (that is, analysis of variance \[ANOVA\]).|ANOVA|||Baseline and Day 42||13.20|5.44|<0.0001
70868119|NCT01323959|141222289|SUPERIORITY_OR_OTHER||Percentage of subjects seroprotected|96.8|||||TWO_SIDED|95.0|89.0|99.6|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result \<0.1 IU/mL) subjects was above 80%.|"The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, 1 month after the booster dose, in at least 80% of the subjects against diphtheria.~Samples were analysed both with ELISA (enzyme-linked immunosorbent assay), and VERO-cell (African green monkey kidney cell) neutralisation testing."||99.6|89|
70868120|NCT01323959|141222289|SUPERIORITY_OR_OTHER||Percentage of subjects seroprotected|95.7|||||TWO_SIDED|95.0|87.8|99.1|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result \<0.1 IU/mL) subjects was above 80%.|The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, one month after the booster dose, in at least 80% of the subjects against diphtheria.||99.1|87.8|
70868121|NCT01323959|141222289|SUPERIORITY_OR_OTHER||Percentage of subjects seroprotected|100.0|||||TWO_SIDED|95.0|94.8|100.0|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result \<0.1 IU/mL) subjects was above 80%.|The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, one month after the booster dose, in at least 80% of the subjects against diphtheria.||100|94.8|
70868122|NCT01323959|141222291|SUPERIORITY_OR_OTHER||Percentage of subjects seroprotected|92.1|||||TWO_SIDED|95.0|82.4|97.4|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result \<0.1 IU/mL) subjects was above 80%.|The objective of the analysis was to dose in study NCT01277705. Samples were analysed both with ELISA (enzyme-linked immunosorbent assay), and VERO-cell (African green monkey kidney cell) neutralisation testing.||97.4|82.4|
70868123|NCT01323959|141222291|SUPERIORITY_OR_OTHER||Percentage of subjects seroprotected|79.4|||||TWO_SIDED|95.0|67.9|88.3|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result \<0.1 IU/mL) subjects was above 80%.|The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, one month after the booster dose, in at least 80% of the subjects against diphtheria.||88.3|67.9|
70868124|NCT01323959|141222291|SUPERIORITY_OR_OTHER||Percentage of subjects seroprotected|84.1|||||TWO_SIDED|95.0|73.3|91.8|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result \<0.1 IU/mL) subjects was above 80%.|The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, one month after the booster dose, in at least 80% of the subjects against diphtheria.||91.8|73.3|
70868125|NCT02993757|141222306|OTHER||GMT ratio|0.982|||||TWO_SIDED|95.0|0.664|1.45||||||Antigen HPV-6||1.45|0.664|
70868126|NCT02993757|141222306|OTHER||GMT ratio|0.804|||||TWO_SIDED|95.0|0.626|1.03||||||Antigen HPV-11||1.03|0.626|
70868127|NCT02993757|141222306|OTHER||GMT ratio|0.815|||||TWO_SIDED|95.0|0.608|1.09||||||Antigen HPV-16||1.09|0.608|
70868128|NCT02993757|141222306|OTHER||GMT ratio|0.795|||||TWO_SIDED|95.0|0.603|1.05||||||Antigen HPV-18||1.05|0.603|
70868129|NCT02993757|141222307|OTHER||GMT ratio|0.987|||||TWO_SIDED|95.0|0.574|1.7||||||Serotype 1||1.70|0.574|
70868130|NCT02993757|141222307|OTHER||GMT ratio|0.783|||||TWO_SIDED|95.0|0.5|1.22||||||Serotype 2||1.22|0.500|
70868131|NCT02993757|141222307|OTHER||GMT ratio|0.836|||||TWO_SIDED|95.0|0.568|1.23||||||Serotype 3||1.23|0.568|
70868132|NCT02993757|141222307|OTHER||GMT ratio|1.07|||||TWO_SIDED|95.0|0.813|1.4||||||Serotype 4||1.40|0.813|
70872227|NCT00407797|141229704|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Percent change evaluated by a one-sample two-sided t-test comparing the difference to zero.||||<.0001
70868133|NCT02762578|141222320|NON_INFERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 1: Primary analysis: Non-inferiority with respect to change from baseline in HbA1c (%) to week 26 for IDegAsp vs. BIAsp 30.~Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.4%."|Treatment contrast|-0.08||||0.243|TWO_SIDED|95.0|-0.2|0.05||Two-sided p-value for testing difference|ANCOVA|||Change from baseline in HbA1c after 26 weeks of treatments was analysed using an ANCOVA method with treatment, anti-diabetic therapy at screening and sex as fixed factors, and age and baseline HbA1c as covariates.||0.05|-0.20|0.2430
70868134|NCT02762578|141222320|SUPERIORITY|"If non-inferiority was confirmed, the superiority of the IDegAsp group over the BIAsp 30 group was to be investigated.~Superiority was considered confirmed if the upper bound of the two-sided 95% confidence interval, which was calculated using the FAS, was below 0%."|Treatment contrast|-0.08||||0.243|TWO_SIDED|95.0|-0.2|0.05||Two-sided p-value for testing difference|ANCOVA|||Change from baseline in HbA1c after 26 weeks of treatments was analysed using an ANCOVA method with treatment, anti-diabetic therapy at screening and sex as fixed factors, and age and baseline HbA1c as covariates.||0.05|-0.20|0.2430
70868135|NCT02762578|141222321|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 2: Superiority with respect to change from baseline in FPG to week 26 for IDegAsp vs. BIAsp 30 (Provided that non-inferiority was confirmed for the primary endpoint)~Superiority was considered confirmed if the 95% CI for the treatment difference (IDegAsp group-BIAsp 30 group) was entirely below zero."|Treatment Contrast|-1.42|||<|0.0001|TWO_SIDED|95.0|-1.74|-1.1||Two-sided p-value for testing difference|ANCOVA|||Change from baseline in FPG after 26 weeks of treatment was analysed using an ANCOVA method with treatment, anti-diabetic therapy at screening and sex as fixed factors, and age and baseline FPG as covariates.||-1.10|-1.74|<0.0001
70868136|NCT02762578|141222322|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 3: Superiority with respect to nocturnal confirmed hypoglycaemic episodes for IDegAsp vs. BIAsp 30 (provided that superiority with respect to change from baseline in FPG to week 26 was confirmed for IDegAsp vs. BIAsp 30).~Superiority was considered confirmed if the 95% CI for the rate ratio (IDegAsp group/BIAsp 30 group) was entirely below one."|Treatment Ratio|0.53||||0.0112|TWO_SIDED|95.0|0.33|0.87|||Negative binomial regression model|||The number of events was analysed using a Negative Binomial Model with a log-link function and the logarithm of the exposure time (100 years) for which a hypoglycaemic episode is considered treatment emergent as offset. The model included treatment, anti-diabetic therapy at screening and sex as fixed factors, and age as covariate.||0.87|0.33|0.0112
70868137|NCT02762578|141222323|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 4: Superiority with respect to confirmed hypoglycaemic episodes for IDegAsp vs. BIAsp 30 (provided that superiority with respect to nocturnal confirmed hypoglycaemic episodes for IDegAsp vs. BIAsp 30 was confirmed).~Superiority was considered confirmed if the 95% CI for the rate ratio (IDegAsp group/BIAsp 30 group) was entirely below one."|Treatment Ratio|0.57||||0.0002|TWO_SIDED|95.0|0.42|0.77|||Negative binomial regression model|||The number of events was analysed using a Negative Binomial Model with a log-link function and the logarithm of the exposure time (100 years) for which a hypoglycaemic episode is considered treatment emergent as offset. The model included treatment, anti-diabetic therapy at screening and sex as fixed factors, and age as covariate||0.77|0.42|0.0002
70868138|NCT02762578|141222324|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 5: Superiority with respect to change from baseline in body weight for IDegAsp vs. BIAsp 30 (provided that Superiority with respect to confirmed hypoglycaemic episodes for IDegAsp vs. BIAsp 30 was confirmed).~Superiority was considered confirmed if the 95% CI for the treatment difference (IDegAsp group-BIAsp 30 group) was entirely below zero"|Treatment contrast|0.61||||0.0092|TWO_SIDED|95.0|0.15|1.08|||ANCOVA|Two-sided p-value for testing difference||The response and change from baseline in response after 26 weeks were analysed using an ANCOVA model with treatment, anti-diabetic therapy at screening and sex as fixed factors, age and baseline response as covariate.||1.08|0.15|0.0092
70868139|NCT02762578|141222325|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 6: Superiority with respect to subjects achieving HbA1c \< 7% at end of trial without confirmed hypoglycaemia for IDegAsp vs. BIAsp 30 (provided that superiority with respect to change from baseline in body weight was confirmed).~Superiority was considered confirmed if the 95% CI for the odds ratio (IDegAsp group/BIAsp 30 group) was entirely above one."|Treatment Ratio|2.22||||0.0002|TWO_SIDED|95.0|1.47|3.35||Two-sided p-value for testing difference|Regression, Logistic|||The endpoint was analysed in a logistic regression model using a logit link, including treatment, sex and anti-diabetic treatment at screening as fixed effects, and age and HbA1c as covariates.||3.35|1.47|0.0002
71142432|NCT03192176|141778544|SUPERIORITY||LSMean differencce|-0.3|STANDARD_ERROR_OF_MEAN|0.4||0.5112|TWO_SIDED|95.0|-1.04|0.52||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||0.52|-1.04|0.5112
70868140|NCT01090492|141222399|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.11||||0.6513|TWO_SIDED|80.0|-0.21|0.44|||ANCOVA|||PRP: Adjusted mean difference analysis was based on Analysis of Covariance (ANCOVA) model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||0.44|-0.21|0.6513
70868141|NCT01090492|141222399|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.69||||0.0057|TWO_SIDED|80.0|-0.99|-0.38|||ANCOVA|||PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||-0.38|-0.99|0.0057
70872228|NCT00407797|141229705|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Participants with \<= 6 seizures during Baseline period.||||<.0001
71142433|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.4||0.03|TWO_SIDED|95.0|-1.66|-0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||-0.09|-1.66|0.0300
70950661|NCT04896008|141402529|SUPERIORITY||Treatment Difference|-7.29||||0.135|TWO_SIDED|95.0|-17.65|2.41||Two-sided p-value is calculated based on Cochran-Mantel-Haenszel method stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Cochran-Mantel-Haenszel||Based on Miettinen and Nurminen method stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype)|||2.41|-17.65|0.135
70950662|NCT04896008|141402530|SUPERIORITY||Treatment Difference|-3.1|||<|0.001|TWO_SIDED|95.0|-4.25|-1.88||Two-sided p-value is provided using aligned rank stratified Wilcoxon test stratified by a randomization stratification factor (PAH subtype).|Aligned Rank Stratified Wilcoxon||Hodges-Lehmann location shift estimate with 95% CI is provided using aligned rank stratified Wilcoxon test stratified by a randomization stratification factor (PAH subtype).|||-1.88|-4.25|<0.001
70950663|NCT04896008|141402531|SUPERIORITY||Treatment Difference|33.05|||<|0.001|TWO_SIDED|95.0|18.41|46.98||Two-sided p-value is calculated based on Cochran-Mantel-Haenszel method stratified by a randomization stratification factor (PAH subtype).|Cochran-Mantel-Haenszel||Based on Miettinen and Nurminen method stratified by a randomization stratification factors (PAH subtype).|||46.98|18.41|<0.001
70950664|NCT04896008|141402532|SUPERIORITY||Treatment Difference|-2339.1|||<|0.001|TWO_SIDED|95.0|-3378.74|-1299.44||Two-sided p-value is provided using aligned rank stratified Wilcoxon test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Aligned Rank Stratified Wilcoxon||Hodges-Lehmann location shift estimate with 95% CI is provided using aligned rank stratified Wilcoxon test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||-1299.44|-3378.74|<0.001
71142434|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.41||0.0634|TWO_SIDED|95.0|-1.57|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||0.04|-1.57|0.0634
70868142|NCT01090492|141222399|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.44||||0.1157|TWO_SIDED|80.0|-0.8|-0.08|||ANCOVA|||SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||-0.08|-0.80|0.1157
70868143|NCT01090492|141222399|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.15||||0.6286|TWO_SIDED|80.0|-0.56|0.25|||ANCOVA|||SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||0.25|-0.56|0.6286
70868144|NCT01090492|141222400|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12||||0.9504|TWO_SIDED|80.0|-2.43|2.68|||ANCOVA|||At Week 4 - PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||2.68|-2.43|0.9504
70868145|NCT01090492|141222400|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.35||||0.4651|TWO_SIDED|80.0|-3.74|1.03|||ANCOVA|||At Week 4 - PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||1.03|-3.74|0.4651
70868146|NCT01090492|141222400|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.59||||0.7423|TWO_SIDED|80.0|-2.92|1.73|||ANCOVA|||At Week 4 - SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||1.73|-2.92|0.7423
70950665|NCT04896008|141402533|SUPERIORITY||Treatment Difference|-21.2|||<|0.001|TWO_SIDED|95.0|-27.78|-14.59||Two-sided p-value is provided using aligned rank stratified Wilcoxon test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Aligned Rank Stratified Wilcoxon||Hodges-Lehmann location shift estimate with 95% CI is provided using aligned rank stratified Wilcoxon test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||-14.59|-27.78|<0.001
70950666|NCT04896008|141402534|SUPERIORITY||Treatment Difference|-339.6|||<|0.001|TWO_SIDED|95.0|-511.09|-168.06||Two-sided p-value is provided using aligned rank stratified Wilcoxon test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Aligned Rank Stratified Wilcoxon||Hodges-Lehmann location shift estimate with 95% CI is provided using aligned rank stratified Wilcoxon test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||-168.06|-511.09|<0.001
70950667|NCT04896008|141402535|SUPERIORITY||Treatment Difference|27.41|||<|0.001|TWO_SIDED|95.0|12.85|40.98||Two-sided p-value is calculated based on Cochran-Mantel-Haenszel method stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Cochran-Mantel-Haenszel||Based on Miettinen and Nurminen method stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||40.98|12.85|<0.001
71142435|NCT03192176|141778544|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.41||0.9406|TWO_SIDED|95.0|-0.78|0.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||0.84|-0.78|0.9406
71142436|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.41||0.1168|TWO_SIDED|95.0|-1.46|0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||0.16|-1.46|0.1168
70872229|NCT00407797|141229705|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Participants with \> 6 seizures during Baseline Period.||||<.0001
71142437|NCT03192176|141778544|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.4||0.9937|TWO_SIDED|95.0|-0.79|0.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||0.80|-0.79|0.9937
70950668|NCT04896008|141402536|SUPERIORITY||Treatment Difference|63.0|||<|0.001|TWO_SIDED|95.0|23.22|102.73||Two-sided p-value is provided using aligned rank stratified Wilcoxon test stratified by randomization stratification factor (REVEAL Lite 2.0 risk score and PAH subtype).|Aligned Rank Stratified Wilcoxon||Hodges-Lehmann location shift estimate with 95% CI is provided using aligned rank stratified Wilcoxon test stratified by randomization stratification factor (REVEAL Lite 2.0 risk score and PAH subtype).|||102.73|23.22|<0.001
70950669|NCT04896008|141402537|SUPERIORITY||Treatment Difference|0.5||||0.119|TWO_SIDED|95.0|-0.18|1.16||Two-sided p-value is provided using aligned rank stratified Wilcoxon test stratified by randomization stratification factor (REVEAL Lite 2.0 risk score and PAH subtype)|Aligned Rank Stratified Wilcoxon||Hodges-Lehmann location shift estimate with 95% CI is provided using aligned rank stratified Wilcoxon test stratified by randomization stratification factor (REVEAL Lite 2.0 risk score and PAH subtype).|||1.16|-0.18|0.119
70950670|NCT01270828|141402548|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Log Rank|||Kaplan-Meier method was used for the analysis.||||<0.0001
70950671|NCT01270828|141402549|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Log Rank|||Kaplan-Meier method was used for the analysis.||||<0.0001
70950672|NCT01270828|141402550|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Chi-squared|||Chi-square test was used for analysis.||||<0.0001
70950673|NCT01270828|141402551|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Chi-squared|||Chi-square test was used for analysis.||||<0.0001
70868147|NCT01090492|141222400|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.91||||0.3524|TWO_SIDED|80.0|-4.55|0.73|||ANCOVA|||At Week 4 - SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||0.73|-4.55|0.3524
70950674|NCT01270828|141402552|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.26|-0.62|||ANCOVA|||This ANCOVA model analysis is for SB Baseline to Week 19. Estimates and p-values are from an ANCOVA main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.||-0.62|-1.26|<0.0001
70950675|NCT01270828|141402552|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.21|-0.61|||ANCOVA|||This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an ANCOVA main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.||-0.61|-1.21|<0.0001
70950676|NCT01270828|141402553|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.47|-0.75|||ANCOVA|||This ANCOVA model analysis is for SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.75|-1.47|<0.0001
70950677|NCT01270828|141402553|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.34|-0.65|||ANCOVA|||This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.65|-1.34|<0.0001
70950678|NCT01270828|141402554|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2||||0.0324|TWO_SIDED|95.0|-6.1|-0.3|||ANCOVA|||This ANCOVA model analysis is for Sleep Problem Index I-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.3|-6.1|0.0324
70950679|NCT01270828|141402554|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3||||0.0223|TWO_SIDED|95.0|-6.1|-0.5|||ANCOVA|||This ANCOVA model analysis is for Sleep Problem Index I-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.5|-6.1|0.0223
70950680|NCT01270828|141402554|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8||||0.0098|TWO_SIDED|95.0|-6.6|-0.9|||ANCOVA|||"This ANCOVA model analysis is for Sleep Problem Index II-SB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||-0.9|-6.6|0.0098
70950681|NCT01270828|141402554|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.0||||0.0033|TWO_SIDED|95.0|-6.7|-1.4|||ANCOVA|||"This ANCOVA model analysis is for Sleep Problem Index II-DB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||-1.4|-6.7|0.0033
70950682|NCT01270828|141402554|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.3||||0.0002|TWO_SIDED|95.0|-11.1|-3.5|||ANCOVA|||This ANCOVA model analysis is for Sleep Disturbance-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-3.5|-11.1|0.0002
70950683|NCT01270828|141402554|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.7|||<|0.0001|TWO_SIDED|95.0|-12.2|-5.2|||ANCOVA|||This ANCOVA model analysis is for Sleep Disturbance-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-5.2|-12.2|<0.0001
70950684|NCT01270828|141402554|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4||||0.5264|TWO_SIDED|95.0|-2.8|5.6|||ANCOVA|||This ANCOVA model analysis is for Snoring-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||5.6|-2.8|0.5264
70950685|NCT01270828|141402554|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.452|TWO_SIDED|95.0|-5.2|2.3|||ANCOVA|||This ANCOVA model analysis is for Snoring-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||2.3|-5.2|0.4520
70950686|NCT01270828|141402554|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5||||0.3714|TWO_SIDED|95.0|-4.7|1.8|||ANCOVA|||"This ANCOVA model analysis is for Awaken Short of Breath or with a Headache-SB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||1.8|-4.7|0.3714
70950687|NCT01270828|141402554|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.5639|TWO_SIDED|95.0|-4.2|2.3|||ANCOVA|||"This ANCOVA model analysis is for Awaken Short of Breath or with a Headache-DB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||2.3|-4.2|0.5639
70950688|NCT01270828|141402554|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5||||0.3223|TWO_SIDED|95.0|-2.4|7.3|||ANCOVA|||This ANCOVA model analysis is for Sleep adequacy-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||7.3|-2.4|0.3223
70950689|NCT01270828|141402554|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.7||||0.2742|TWO_SIDED|95.0|-2.2|7.6|||ANCOVA|||This ANCOVA model analysis is for Sleep adequacy-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||7.6|-2.2|0.2742
70950690|NCT01270828|141402554|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9816|TWO_SIDED|95.0|-3.2|3.1|||ANCOVA|||This ANCOVA model analysis is for Somnolence-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||3.1|-3.2|0.9816
71142438|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.1858|TWO_SIDED|95.0|-1.32|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||0.26|-1.32|0.1858
71142439|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.5765|TWO_SIDED|95.0|-0.65|0.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.36|-0.65|0.5765
71142440|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.26||0.1848|TWO_SIDED|95.0|-0.86|0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.17|-0.86|0.1848
70950691|NCT01270828|141402554|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.9282|TWO_SIDED|95.0|-2.9|3.2|||ANCOVA|||This ANCOVA model analysis is for Somnolence-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||3.2|-2.9|0.9282
70950692|NCT01270828|141402555|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.1635|TWO_SIDED|95.0|-0.1|0.4|||ANCOVA|||This ANCOVA model analysis is for SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||0.4|-0.1|0.1635
70950693|NCT01270828|141402555|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.0363||95.0|0.0|0.5|||ANCOVA|||This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||0.5|0.0|0.0363
70950694|NCT01270828|141402556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.432|||||||Chi-squared|||This analysis is for Week 6||||0.432
70950695|NCT01270828|141402556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.987|||||||Chi-squared|||This analysis is for Week 19||||0.987
70950696|NCT01270828|141402557|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.85||||0.0007|TWO_SIDED|95.0|1.3|2.65|||Regression, Logistic||"Odds ratio is the probability of the event occurring in Pregabalin DB relative to the event occurring in Placebo DB.~Odds ratio \> 1 is in favor of Pregabalin DB."|This analysis is for the original score. Proportional odds Logistic regression with a term for treatment in the model.||2.65|1.30|0.0007
70950697|NCT01270828|141402557|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.32||||0.0009|TWO_SIDED|95.0|1.41|3.81|||Regression, Logistic||"Odds ratio is the probability of the event occurring in Pregabalin DB relative to the event occurring in Placebo DB.~Odds ratio \> 1 is in favor of Pregabalin DB."|This analysis is for the categorized score. Proportional odds Logistic regression with a term for treatment in the model.||3.81|1.41|0.0009
70950698|NCT01270828|141402558|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.4||||0.0003|TWO_SIDED|95.0|3.4|11.5|||ANCOVA|||This ANCOVA model analysis is for Bodily pain-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||11.5|3.4|0.0003
70950699|NCT01270828|141402558|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.7|||<|0.0001|TWO_SIDED|95.0|4.0|11.3|||ANCOVA|||This ANCOVA model analysis is for Bodily pain-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||11.3|4.0|<0.0001
70950700|NCT01270828|141402558|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.2||||0.0275|TWO_SIDED|95.0|0.4|6.0|||ANCOVA|||"This ANCOVA model analysis is for General Health Perceptions-SB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||6.0|0.4|0.0275
71142441|NCT03192176|141778544|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.26||0.7299|TWO_SIDED|95.0|-0.43|0.61||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.61|-0.43|0.7299
70950701|NCT01270828|141402558|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.4|||<|0.0001|TWO_SIDED|95.0|2.8|8.0|||ANCOVA|||"This ANCOVA model analysis is for General Health Perceptions-DB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||8.0|2.8|<0.0001
70950702|NCT01270828|141402558|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.0||||0.0735|TWO_SIDED|95.0|-0.3|6.4|||ANCOVA|||This ANCOVA model analysis is for Vitality-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||6.4|-0.3|0.0735
70950703|NCT01270828|141402558|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.0||||0.0684|TWO_SIDED|95.0|-0.2|6.2|||ANCOVA|||This ANCOVA model analysis is for Vitality-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||6.2|-0.2|0.0684
70950704|NCT01270828|141402558|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.8||||0.1197|TWO_SIDED|95.0|-0.7|6.4|||ANCOVA|||This ANCOVA model analysis is for Social Functioning-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||6.4|-0.7|0.1197
70950705|NCT01270828|141402558|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.1||||0.221|TWO_SIDED|95.0|-1.3|5.5|||ANCOVA|||This ANCOVA model analysis is for Social Functioning-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||5.5|-1.3|0.2210
70950706|NCT01270828|141402558|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.3||||0.0847|TWO_SIDED|95.0|-0.5|7.1|||ANCOVA|||This ANCOVA model analysis is for Role-Emotional-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||7.1|-0.5|0.0847
70868148|NCT01090492|141222401|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.21||||0.79|TWO_SIDED|80.0|-4.61|7.03|||ANCOVA|||PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||7.03|-4.61|0.7900
70950707|NCT01270828|141402558|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.0||||0.0365|TWO_SIDED|95.0|0.3|7.8|||ANCOVA|||This ANCOVA model analysis is for Role-Emotional-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||7.8|0.3|0.0365
70950708|NCT01270828|141402558|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6||||0.2749|TWO_SIDED|95.0|-1.2|4.3|||ANCOVA|||This ANCOVA model analysis is for Mental Health-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||4.3|-1.2|0.2749
70950709|NCT01270828|141402558|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5||||0.0806|TWO_SIDED|95.0|-0.3|5.2|||ANCOVA|||This ANCOVA model analysis is for Mental Health-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||5.2|-0.3|0.0806
70950710|NCT01270828|141402558|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.0||||0.0082|TWO_SIDED|95.0|0.5|3.4|||ANCOVA|||This ANCOVA model analysis is for Physical component-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||3.4|0.5|0.0082
70950711|NCT01270828|141402558|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.3||||0.0008|TWO_SIDED|95.0|1.0|3.7|||ANCOVA|||This ANCOVA model analysis is for Physical component-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||3.7|1.0|0.0008
70950712|NCT01270828|141402558|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.2097|TWO_SIDED|95.0|-0.8|2.5|||ANCOVA|||This ANCOVA model analysis is for Mental component-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||2.5|-0.8|0.2097
70950713|NCT01270828|141402558|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.2||||0.1669|TWO_SIDED|95.0|-0.5|2.8|||ANCOVA|||This ANCOVA model analysis is for Mental component-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||2.8|-0.5|0.1669
70950714|NCT01270828|141402558|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.8||||0.1466|TWO_SIDED|95.0|-1.0|6.7|||ANCOVA|||This ANCOVA model analysis is for Physical functioning-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||6.7|-1.0|0.1466
70950715|NCT01270828|141402558|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.4||||0.0439|TWO_SIDED|95.0|0.1|6.7|||ANCOVA|||This ANCOVA model analysis is for Physical functioning-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||6.7|0.1|0.0439
70950716|NCT01270828|141402558|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.9||||0.025|TWO_SIDED|95.0|0.6|9.3|||ANCOVA|||This ANCOVA model analysis is for Role Physical-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||9.3|0.6|0.0250
71142442|NCT03192176|141778544|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.9415|TWO_SIDED|95.0|-0.54|0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.50|-0.54|0.9415
71142443|NCT03192176|141778544|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.27||0.2742|TWO_SIDED|95.0|-0.82|0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.23|-0.82|0.2742
70950717|NCT01270828|141402558|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.4||||0.0107|TWO_SIDED|95.0|1.3|9.5|||ANCOVA|||This ANCOVA model analysis is for Role Physical-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||9.5|1.3|0.0107
70950718|NCT01270828|141402559|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.23|-0.64|||ANCOVA|||This ANCOVA model analysis is for SB Baseline to Week 19.Estimates and p-values are from an analysis of covariance main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.||-0.64|-1.23|<0.0001
70950719|NCT01270828|141402559|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.12|-0.58|||ANCOVA|||This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.||-0.58|-1.12|<0.0001
70950720|NCT01270828|141402560|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.0154|TWO_SIDED|95.0|-1.2|-0.1|||ANCOVA|||This ANCOVA model analysis is for HADS-Anxiety-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.1|-1.2|0.0154
70950721|NCT01270828|141402560|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.0027|TWO_SIDED|95.0|-1.3|-0.3|||ANCOVA|||This ANCOVA model analysis is for HADS-Anxiety-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.3|-1.3|0.0027
70950722|NCT01270828|141402560|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.0166|TWO_SIDED|95.0|-1.2|-0.1|||ANCOVA|||This ANCOVA model analysis is for HADS-Depression-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.1|-1.2|0.0166
70950723|NCT01270828|141402560|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.0217|TWO_SIDED|95.0|-1.1|-0.1|||ANCOVA|||This ANCOVA model analysis is for HADS-Depression-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.1|-1.1|0.0217
70950724|NCT01270828|141402561|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.2|||<|0.0001|TWO_SIDED|95.0|-5.5|-3.0|||ANCOVA|||This ANCOVA model analysis is for Pain Severity Index-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-3.0|-5.5|<0.0001
70950725|NCT01270828|141402561|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8|||<|0.0001|TWO_SIDED|95.0|-5.0|-2.7|||ANCOVA|||This ANCOVA model analysis is for Pain Severity Index-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-2.7|-5.0|<0.0001
71142444|NCT03192176|141778544|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.26||0.6946|TWO_SIDED|95.0|-0.41|0.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.62|-0.41|0.6946
71142445|NCT03192176|141778544|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.9442|TWO_SIDED|95.0|-0.53|0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.50|-0.53|0.9442
70868149|NCT01090492|141222401|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.17||||0.1463|TWO_SIDED|80.0|-11.61|-0.73|||ANCOVA|||PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||-0.73|-11.61|0.1463
70950726|NCT01270828|141402561|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6|||<|0.0001|TWO_SIDED|95.0|-6.5|-2.7|||ANCOVA|||"This ANCOVA model analysis is for Pain Interference Index-SB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||-2.7|-6.5|<0.0001
70950727|NCT01270828|141402561|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.2|||<|0.0001|TWO_SIDED|95.0|-6.0|-2.4|||ANCOVA|||"This ANCOVA model analysis is for Pain Interference Index-DB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||-2.4|-6.0|<0.0001
70950728|NCT01270828|141402562|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.77||||0.0161|TWO_SIDED|95.0|1.34|17.0|||Regression, Logistic||Odds ratio was the probability of the event occurring in pregabalin CR DB relative to the event occurring in placebo DB. Odds ratio \> 1 was in favor of pregabalin CR.|This analysis is for 'Benefit from treatment'. Proportional odds logistic regression was used with a term for treatment in the model.||17.00|1.34|0.0161
70950729|NCT01270828|141402562|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.48||||0.0378|TWO_SIDED|95.0|1.05|5.85|||Regression, Logistic||Odds ratio was the probability of the event occurring in pregabalin CR DB relative to the event occurring in placebo DB. Odds ratio \> 1 was in favor of pregabalin CR.|This analysis is for 'Satisfaction with treatment'. Proportional odds logistic regression was used with a term for treatment in the model.||5.85|1.05|0.0378
70950730|NCT01270828|141402562|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.61||||0.0901|TWO_SIDED|95.0|0.93|2.81|||Regression, Logistic||Odds ratio was the probability of the event occurring in pregabalin CR DB relative to the event occurring in placebo DB. Odds ratio \> 1 was in favor of pregabalin CR.|This analysis is for 'Willingness to continue treatment'. Proportional odds logistic regression was used with a term for treatment in the model.||2.81|0.93|0.0901
70950731|NCT00709228|141402578|SUPERIORITY_OR_OTHER||simple proportion|0.097|||||TWO_SIDED|95.0|0.06|0.15||||||||0.15|0.06|
71142446|NCT04244253|141778555|SUPERIORITY||Difference of score|-1.1||||0.288|TWO_SIDED|95.0|-3.3|1.0|||Mixed-model repeated measures|MMRM included treatment, visit, treatment-by-visit interaction, baseline, and baseline-by-visit interaction using an unstructured covariance matrix.||The statistical analysis was performed at Week 6 to compare the OPC-64005 20-mg group and placebo group.||1.0|-3.3|0.288
70950732|NCT02870972|141402584|SUPERIORITY||Difference in Least Square Means|-0.458|||<|0.001|TWO_SIDED|95.0|-0.703|-0.214|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.214|-0.703|<0.001
70950733|NCT02870972|141402584|SUPERIORITY||Difference in Least Square Means|-0.433||||0.006|TWO_SIDED|95.0|-0.74|-0.127|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.127|-0.740|0.006
70950734|NCT02870972|141402584|SUPERIORITY||Difference in Least Square Means|-0.425||||0.012|TWO_SIDED|95.0|-0.755|-0.095|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.095|-0.755|0.012
70950735|NCT02870972|141402584|SUPERIORITY||Difference in Least Square Means|-0.703|||<|0.001|TWO_SIDED|95.0|-1.033|0.373|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.373|-1.033|<0.001
70950736|NCT02870972|141402584|SUPERIORITY||Difference in Least Square Means|-0.1||||0.639|TWO_SIDED|95.0|-0.52|0.32|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.32|-0.52|0.639
70950737|NCT02870972|141402585|SUPERIORITY||Difference vs placebo (%)|17.7||||0.155|TWO_SIDED|95.0|-3.4|38.8|||Fisher Exact|||||38.8|-3.4|0.155
70950738|NCT02870972|141402585|SUPERIORITY||Difference vs placebo (%)|16.9||||0.277|TWO_SIDED|95.0|-6.3|40.1|||Fisher Exact|||||40.1|-6.3|0.277
70950739|NCT02870972|141402585|SUPERIORITY||Difference vs placebo (%)|24.0||||0.064|TWO_SIDED|95.0|-1.2|49.2|||Fisher Exact|||||49.2|-1.2|0.064
71142447|NCT04244253|141778556|OTHER||Difference in response rate|5.6||||0.329|TWO_SIDED|95.0|-5.6|16.8|||χ2 test|The MADRS response rate in the OPC-64005 20-mg group and the placebo group were compared using the χ2 test in the LOCF dataset.||The statistical analysis was performed at Week 6 to compare the OPC-64005 20-mg group and placebo group.||16.8|-5.6|0.329
70950740|NCT02870972|141402585|SUPERIORITY||Difference vs placebo (%)|-4.5||||1|TWO_SIDED|95.0|-13.2|4.2|||Fisher Exact|||||4.2|-13.2|1.000
70950741|NCT02870972|141402585|SUPERIORITY||Difference vs placebo (%)|-16.2||||0.097|TWO_SIDED|95.0|-30.2|-2.2|||Fisher Exact|||||-2.2|-30.2|0.097
70950742|NCT02870972|141402586|SUPERIORITY||Difference in Least Square Means|-0.061||||0.439|TWO_SIDED|95.0|-0.216|0.094|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.094|-0.216|0.439
70950743|NCT02870972|141402586|SUPERIORITY||Difference in Least Square Means|-0.004||||0.968|TWO_SIDED|95.0|-0.198|0.19|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.190|-0.198|0.968
70950744|NCT02870972|141402586|SUPERIORITY||Difference in Least Square Means|-0.045||||0.667|TWO_SIDED|95.0|-0.254|0.164|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.164|-0.254|0.667
70950745|NCT02870972|141402586|SUPERIORITY||Difference in Least Square Means|-0.197||||0.065|TWO_SIDED|95.0|-0.406|0.012|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.012|-0.406|0.065
70950746|NCT02870972|141402586|SUPERIORITY||Difference in Least Square Means|0.035||||0.797|TWO_SIDED|95.0|-0.232|0.301|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.301|-0.232|0.797
70950747|NCT02870972|141402587|SUPERIORITY||Difference in Least Square Means|-0.364|||<|0.001|TWO_SIDED|95.0|-0.547|-0.181|||ANOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.181|-0.547|<0.001
70950748|NCT02870972|141402587|SUPERIORITY||Difference in Least Square Means|-0.384||||0.001|TWO_SIDED|95.0|-0.613|-0.154|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.154|-0.613|0.001
70950749|NCT02870972|141402587|SUPERIORITY||Difference in Least Square Means|-0.401||||0.002|TWO_SIDED|95.0|-0.647|-0.154|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.154|-0.647|0.002
70950750|NCT02870972|141402587|SUPERIORITY||Difference in Least Square Means|-0.445|||<|0.001|TWO_SIDED|95.0|-0.692|-0.198|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.198|-0.692|<0.001
70950751|NCT02870972|141402587|SUPERIORITY||Difference in Least Square Means|-0.08||||0.614|TWO_SIDED|95.0|-0.394|0.234|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.234|-0.394|0.614
70950752|NCT02870972|141402588|SUPERIORITY||Difference in Least Square Means|-0.326||||0.006|TWO_SIDED|95.0|-0.557|-0.095|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-0.095|-0.557|0.006
70950753|NCT02870972|141402588|SUPERIORITY||Difference in Least Square Means|-0.293||||0.047|TWO_SIDED|95.0|-0.582|0.004|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||0.004|-0.582|0.047
71142448|NCT04244253|141778557|OTHER||Difference of Proportion|1.5||||0.731|TWO_SIDED|95.0|-7.2|10.3|||χ2 test|The MADRS remission rate in the OPC-64005 20-mg group and placebo group were compared using the χ2 test in the LOCF dataset.||The statistical analysis was performed at Week 6 to compare the OPC-64005 20-mg group and placebo group.||10.3|-7.2|0.731
71142449|NCT04663321|141778558|SUPERIORITY|Difference in LS Means|LS Mean Difference|3.3||||0.168|TWO_SIDED|95.0|-1.4|8.0|||ANCOVA|||||8.0|-1.4|0.168
71142450|NCT04663321|141778558|SUPERIORITY|Difference in LS Means|LS Mean Difference|-1.1||||0.697|TWO_SIDED|95.0|-6.9|4.7|||ANCOVA|||||4.7|-6.9|0.697
71142451|NCT04663321|141778559|SUPERIORITY|Difference in LS Means|LS Mean Difference|2.9||||0.124|TWO_SIDED|95.0|-0.8|6.6|||ANCOVA|||||6.6|-0.8|0.124
70950754|NCT02870972|141402588|SUPERIORITY||Difference in Least Square Means|-0.327||||0.04|TWO_SIDED|95.0|-0.638|-0.016|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-0.016|-0.638|0.040
70950755|NCT02870972|141402588|SUPERIORITY||Difference in Least Square Means|-0.558|||<|0.001|TWO_SIDED|95.0|-0.87|-0.247|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-0.247|-0.870|<0.001
70950756|NCT02870972|141402588|SUPERIORITY||Difference in Least Square Means|0.057||||0.775|TWO_SIDED|95.0|-0.339|0.454|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||0.454|-0.339|0.775
70950757|NCT02870972|141402589|SUPERIORITY||Difference in Least Square Means|-4.449||||0.209|TWO_SIDED|95.0|-11.453|2.555|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||2.555|-11.453|0.209
70950758|NCT02870972|141402589|SUPERIORITY||Difference in Least Square Means|-9.103||||0.019|TWO_SIDED|95.0|-16.639|-1.567|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-1.567|-16.639|0.019
71142452|NCT04663321|141778559|SUPERIORITY|Difference in LS Means|LS Mean Difference|1.9||||0.417|TWO_SIDED|95.0|-2.7|6.4|||ANCOVA|||||6.4|-2.7|0.417
70868150|NCT01090492|141222401|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.37||||0.1446|TWO_SIDED|80.0|-4.44|-0.29|||ANCOVA|||SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||-0.29|-4.44|0.1446
70872230|NCT00407797|141229711|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0552|TWO_SIDED|95.0|||||t-test, 2 sided|||Week 21: Sleep Disturbance. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0552
70950759|NCT02870972|141402589|SUPERIORITY||Difference in Least Square Means|-11.263||||0.004|TWO_SIDED|95.0|-18.808|-3.718|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-3.718|-18.808|0.004
70950760|NCT02870972|141402589|SUPERIORITY||Difference in Least Square Means|4.04||||0.405|TWO_SIDED|95.0|-5.586|13.665|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||13.665|-5.586|0.405
70950761|NCT02870972|141402590|SUPERIORITY||Difference in Least Square Means|-8.12||||0.135|TWO_SIDED|95.0|-18.826|2.584|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||2.584|-18.826|0.135
70950762|NCT02870972|141402590|SUPERIORITY||Difference in Least Square Means|-8.92||||0.121|TWO_SIDED|95.0|-20.26|2.41|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||2.410|-20.260|0.121
70950763|NCT02870972|141402590|SUPERIORITY||Difference in Least Square Means|-24.49|||<|0.001|TWO_SIDED|95.0|-35.834|-13.137|||ANOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-13.137|-35.834|<0.001
70950764|NCT02870972|141402590|SUPERIORITY||Difference in Least Square Means|-7.84||||0.284|TWO_SIDED|95.0|-22.316|6.64|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||6.640|-22.316|0.284
70950765|NCT02870972|141402591|SUPERIORITY||Difference in Least Square Means|-8.27||||0.067|TWO_SIDED|95.0|-17.132|0.592|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||0.592|-17.132|0.067
70950766|NCT02870972|141402591|SUPERIORITY||Difference in Least Square Means|-7.073||||0.136|TWO_SIDED|95.0|-16.432|2.287|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||2.287|-16.432|0.136
71142453|NCT04663321|141778562|SUPERIORITY|Difference in LS Means|LS Mean Difference|2.0||||0.187|TWO_SIDED|95.0|-1.0|5.1|||ANCOVA|||||5.1|-1.0|0.187
71142454|NCT04663321|141778562|SUPERIORITY|Difference in LS Means|LS Mean Difference|-0.6||||0.738|TWO_SIDED|95.0|-4.3|3.1|||ANCOVA|||||3.1|-4.3|0.738
71142455|NCT04663321|141778563|SUPERIORITY|Difference in LS means|LS Mean Difference|1.7||||0.182|TWO_SIDED|95.0|-0.8|4.3|||ANCOVA|||||4.3|-0.8|0.182
71142456|NCT04663321|141778564|SUPERIORITY|Difference in LS Means|LS Mean Difference|0.1||||0.63|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||||0.7|-0.4|0.630
71142457|NCT04663321|141778564|SUPERIORITY|Difference in LS Means|LS Mean Difference|-0.2||||0.549|TWO_SIDED|95.0|-0.9|0.5|||ANCOVA|||||0.5|-0.9|0.549
70950767|NCT02870972|141402591|SUPERIORITY||Difference in Least Square Means|-11.484||||0.015|TWO_SIDED|95.0|-20.642|-2.325|||ANOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-2.325|-20.642|0.015
70950768|NCT02870972|141402591|SUPERIORITY||Difference in Least Square Means|-9.785||||0.114|TWO_SIDED|95.0|-22.001|2.431|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||2.431|-22.001|0.114
70950769|NCT02179177|141402606|OTHER||Mean Difference (Net)|1.0||||0.11|TWO_SIDED||||||t-test, 2 sided|||||||0.11
70950770|NCT03322540|141402610|SUPERIORITY||Difference in Percentages|-6.5||||0.8|TWO_SIDED|95.0|-21.5|8.7|||Stratified Miettinen and Nurminen method|One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Point estimate was assessed based on Miettinen \& Nurminen method stratified by predominant tumor histology (squamous vs non-squamous).|||8.7|-21.5|0.8000
70950771|NCT04052425|141402616|SUPERIORITY||Odds Ratio (OR)|5.28|||<|0.0001|TWO_SIDED|95.0|2.341|11.903||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||11.903|2.341|< 0.0001
70950772|NCT04052425|141402617|SUPERIORITY||Odds Ratio (OR)|5.18|||<|0.0001|TWO_SIDED|95.0|2.831|9.482||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||9.482|2.831|< 0.0001
70950773|NCT04052425|141402618|SUPERIORITY||Odds Ratio (OR)|8.49||||0.0038|TWO_SIDED|95.0|1.997|36.048||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||36.048|1.997|0.0038
70950774|NCT04052425|141402619|SUPERIORITY||Odds Ratio (OR)|4.93||||0.002|TWO_SIDED|95.0|1.795|13.566||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||13.566|1.795|0.0020
70950775|NCT04052425|141402620|SUPERIORITY||Odds Ratio (OR)|9.53||||0.0002|TWO_SIDED|95.0|2.9|31.29||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||31.290|2.900|0.0002
70950776|NCT04052425|141402621|SUPERIORITY||least squares mean difference|-19.3|STANDARD_ERROR_OF_MEAN|3.93|<|0.0001|TWO_SIDED|95.0|-27.05|-11.64||Response Variable = Treatment + Stratification Factors (Skin Type Fitzpatrick scale Type I, II versus Type III, IV, V, and VI, Region North America/Europe) + Baseline|ANCOVA|||||-11.64|-27.05|< 0.0001
71142458|NCT04663321|141778565|SUPERIORITY|Difference in LS Means|LS Mean Difference|0.4||||0.062|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||||0.8|-0.0|0.062
70950777|NCT04052425|141402624|SUPERIORITY||Odds Ratio (OR)|5.56|||<|0.0001|TWO_SIDED|95.0|3.226|9.578||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||9.578|3.226|< 0.0001
70950778|NCT04052425|141402626|SUPERIORITY||least squares mean difference|-30.61|STANDARD_ERROR_OF_MEAN|4.28|<|0.0001|TWO_SIDED|95.0|-39.03|-22.19|||mixed-effect model; repeated measurement|||||-22.19|-39.03|<0.0001
70950779|NCT04052425|141402629|SUPERIORITY||least squares mean difference|-16.98|STANDARD_ERROR_OF_MEAN|3.2|<|0.0001|TWO_SIDED|95.0|-23.28|-10.68|||mixed-effect model; repeated measurement|||||-10.68|-23.28|<0.0001
70950780|NCT04052425|141402631|SUPERIORITY||least squares mean difference|-9.07|STANDARD_ERROR_OF_MEAN|2.49||0.0003|TWO_SIDED|95.0|-13.96|-4.18|||mixed-effect model; repeated measurement|||||-4.18|-13.96|0.0003
70950781|NCT04052425|141402633|SUPERIORITY||Odds Ratio (OR)|3.04|||<|0.0001|TWO_SIDED|95.0|1.746|5.307||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||T-VASI25||5.307|1.746|< 0.0001
70950782|NCT04052425|141402633|SUPERIORITY||Odds Ratio (OR)|2.3||||0.2921|TWO_SIDED|95.0|0.489|10.823||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||T-VASI75||10.823|0.489|0.2921
70950783|NCT04052425|141402633|SUPERIORITY||Odds Ratio (OR)|0.49||||||||||The p value was not evaluable because the response rate in the vehicle group was too low.||||T-VASI90||||
70950784|NCT04052425|141402636|SUPERIORITY||least squares mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.48||0.497|TWO_SIDED|95.0|-1.26|0.62|||mixed-effect model; repeated measurement|||||0.62|-1.26|0.4970
70950785|NCT02330094|141402651|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.7
70950786|NCT02330094|141402652|SUPERIORITY|||||||0.79|||||||ANOVA|||||||0.79
70950787|NCT02330094|141402653|SUPERIORITY|||||||0.66|||||||ANOVA|||||||0.66
70950788|NCT03445533|141402654|SUPERIORITY|||||||0.9394||||||p-value was calculated for percentage difference (B-A) using a Cochran-Mantel-Haenszel (CMH) test stratified by metastasis stage and BRAF mutation.|Cochran-Mantel-Haenszel|ORR and OS comprise a primary endpoint family; both have a priori hypotheses and were tested for statistical significance.||The ORR was defined as a percentage of subjects meeting criteria of CR and PR to calculate the p-value.||||0.9394
70950789|NCT03445533|141402655|SUPERIORITY||Cox Proportional Hazard|0.955||||0.6775|TWO_SIDED|95.0|0.77|1.186||The p-value was calculated using the log rank test stratified by metastasis stage and BRAF mutation.|Log Rank|ORR and OS comprise a primary endpoint family; both have a priori hypotheses. ORR will be tested first followed by OS.|Hazard ratio and 95% CI (B/A) are estimated using a Cox proportional hazards model stratified by metastasis stage and BRAF mutation.|||1.186|0.770|0.6775
71142459|NCT04663321|141778565|SUPERIORITY|Difference in LS Means|LS Mean Difference|0.0||||0.878|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||||0.5|-0.5|0.878
71142460|NCT05108246|141778567|SUPERIORITY|||||||0.001||||||P-value is calculated.|Wilcoxon (Mann-Whitney)|||Change in balance was assessed by calculating a change score between pre-test and end point scores for balance. Change scores were then compared using Mann-Whitney U test and reported as Median (Interquartile range).||||.001
71142461|NCT05108246|141778567|SUPERIORITY|||||||0.003||||||P-value is calculated.|Wilcoxon (Mann-Whitney)|||Change in balance was assessed by calculating a change score between pre-test and end point scores for balance. Change scores were then compared using Mann-Whitney U test and reported as Median (Interquartile range).||||.003
71142462|NCT00117637|141778602|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.5|TWO_SIDED|95.0|0.61|1.27||The log rank test is stratified by region (western Europe, Eastern Europe, USA) and by Motzer risk category (low, intermediate).|Log Rank|||The study was planned to show a 80% improvement in PFS for the group treated with Sorafenib compared to the group treated with Interferon, with a 80% power and a 2-sided type I error of 5%||1.27|0.61|0.50
70950790|NCT00945672|141402713|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|3.959||0.9779|TWO_SIDED|90.0|-6.49|6.71|||Mixed Models Analysis|||Month 3: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||6.71|-6.49|0.9779
70950791|NCT00945672|141402713|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|3.815||0.8801|TWO_SIDED|90.0|-5.79|6.94|||Mixed Models Analysis|||Month 6: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||6.94|-5.79|0.8801
70950792|NCT00945672|141402713|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|3.845||0.9412|TWO_SIDED|90.0|-6.13|6.7|||Mixed Models Analysis|||Month 9: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||6.70|-6.13|0.9412
70950793|NCT00945672|141402713|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.36|STANDARD_ERROR_OF_MEAN|4.223||0.7486|TWO_SIDED|90.0|-8.38|5.66|||Mixed Models Analysis|||Month 13: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||5.66|-8.38|0.7486
70950794|NCT00945672|141402713|SUPERIORITY_OR_OTHER_LEGACY||L S Mean Difference|8.18|STANDARD_ERROR_OF_MEAN|4.171||0.0534|TWO_SIDED|90.0|1.24|15.12|||Mixed Models Analysis|||Month 18: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||15.12|1.24|0.0534
70950795|NCT00945672|141402713|SUPERIORITY_OR_OTHER_LEGACY||L S Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|3.776||0.998|TWO_SIDED|90.0|-6.29|6.31|||Mixed Models Analysis|||Month 3: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||6.31|-6.29|0.9980
70950796|NCT00945672|141402713|SUPERIORITY_OR_OTHER_LEGACY||L S Mean Difference|3.35|STANDARD_ERROR_OF_MEAN|3.958||0.4004|TWO_SIDED|90.0|-3.25|9.94|||Mixed Models Analysis|||Month 6: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||9.94|-3.25|0.4004
70950797|NCT00945672|141402713|SUPERIORITY_OR_OTHER_LEGACY||L S Mean Difference|1.81|STANDARD_ERROR_OF_MEAN|4.214||0.6685|TWO_SIDED|90.0|-5.2|8.82|||Mixed Models Analysis|||Month 9: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||8.82|-5.20|0.6685
71142463|NCT00117637|141778603|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.882||||0.469|TWO_SIDED|95.0|0.628|1.239||The log rank test is stratified by region (western Europe, Eastern Europe, USA) and by Motzer risk category (low, intermediate).|Log Rank|||The study was planned to show a 80% improvement in PFS for the group treated with Sorafenib compared to the group treated with Interferon, with a 80% power and a 2-sided type I error of 5%||1.239|0.628|0.469
70950798|NCT00945672|141402713|SUPERIORITY_OR_OTHER_LEGACY||L S Mean Difference|4.74|STANDARD_ERROR_OF_MEAN|4.522||0.2968|TWO_SIDED|90.0|-2.77|12.25|||Mixed Models Analysis|||Month 13: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||12.25|-2.77|0.2968
70950799|NCT00945672|141402713|SUPERIORITY_OR_OTHER_LEGACY||L S Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|4.494||0.772|TWO_SIDED|90.0|-8.77|6.16|||Mixed Models Analysis|||Month 18: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||6.16|-8.77|0.7720
70950800|NCT00945672|141402714|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|8.789||0.8205|TWO_SIDED|90.0|-12.68|16.69|||Mixed Models Analysis|||Month 6: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||16.69|-12.68|0.8205
70950801|NCT00945672|141402714|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.37|STANDARD_ERROR_OF_MEAN|8.789||0.2007|TWO_SIDED|90.0|-3.31|26.06|||Mixed Models Analysis|||Month 13: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||26.06|-3.31|0.2007
70950802|NCT00945672|141402714|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|8.9|STANDARD_ERROR_OF_MEAN|0.8789||0.3152|TWO_SIDED|90.0|-5.78|23.59|||Mixed Models Analysis|||Month 18: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||23.59|-5.78|0.3152
70950803|NCT00945672|141402714|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|8.964||0.8071|TWO_SIDED|90.0|-17.18|12.79|||Mixed Models Analysis|||Month 6: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||12.79|-17.18|0.8071
70950804|NCT00945672|141402714|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|9.354||0.9918|TWO_SIDED|90.0|-15.72|15.52|||Mixed Models Analysis|||Month 13: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||15.52|-15.72|0.9918
70950805|NCT00945672|141402714|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.01|STANDARD_ERROR_OF_MEAN|9.415||0.7498|TWO_SIDED|90.0|-18.73|12.7|||Mixed Models Analysis|||Month 18: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||12.70|-18.73|0.7498
70950806|NCT00945672|141402715|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.35|STANDARD_ERROR_OF_MEAN|1.91||0.4855|TWO_SIDED|90.0|-1.9|4.6|||ANCOVA|||Month 13: Analysis of covariance (ANCOVA) with cohort by treatment interaction as fixed effect and baseline scores as covariate.||4.60|-1.90|0.4855
70950807|NCT00945672|141402715|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.45|STANDARD_ERROR_OF_MEAN|2.185||0.5132|TWO_SIDED|90.0|-2.27|5.16|||ANCOVA|||Month 13: Analysis of covariance (ANCOVA) with cohort by treatment interaction as fixed effect and baseline scores as covariate.||5.16|-2.27|0.5132
70950808|NCT03926195|141402759|OTHER||Difference in Percentage|5.8|||||TWO_SIDED|95.0|-7.5|19.2|||||Difference in percentage and 95% confidence interval (CI) was based on a stratified Mantel-Haenszel test.|||19.2|-7.5|
71142464|NCT00117637|141778604|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||The Cochran-Mantel-Haenszel statistics was stratified by region and Motzer risk category.|Cochran-Mantel-Haenszel|||||||0.006
71142465|NCT00117637|141778605|SUPERIORITY_OR_OTHER|||||||0.0004||95.0||||the Cochran-Mantel-Haenszel statistics was stratified by region and Motzer risk category.|Cochran-Mantel-Haenszel|||||||0.0004
70872231|NCT00407797|141229711|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035|TWO_SIDED|95.0|||||t-test, 2 sided|||LOCF: Sleep Disturbance. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0350
70950809|NCT03926195|141402761|OTHER||Median Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-6.4|3.5|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||3.5|-6.4|
70950810|NCT03926195|141402763|OTHER||Median Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-37.1|36.8|||||Difference in medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||36.8|-37.1|
70950811|NCT03926195|141402765|OTHER||Median Difference (Final Values)|7.4|||||TWO_SIDED|95.0|-6.0|20.8|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||20.8|-6.0|
70950812|NCT03926195|141402767|OTHER||Median Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-0.6|0.1|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||0.1|-0.6|
70950813|NCT03926195|141402769|OTHER||Median Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-3.0|1.0|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||1|-3|
70950814|NCT00447590|141402804|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||2-sided Exact Binomial Test|||p-Value is from a 2-sided exact binomial test to test the null hypothesis that 30% of subjects have at least 30% EWL.||||<0.0001
70950815|NCT00479882|141402832|NON_INFERIORITY_OR_EQUIVALENCE|Clinical equivalence LDL-C reduction was established if the 95% CI for the difference between these two treatments in percent change from baseline in LDL-C fell within ±3%.|Difference in Least squares mean|2.4|||||TWO_SIDED|95.0|1.3|3.4|||ANOVA|Factors for sequence, participant within sequence, period and treatment||||3.4|1.3|
70950816|NCT00479882|141402832|NON_INFERIORITY_OR_EQUIVALENCE|Clinical equivalence LDL-C reduction was established if the 95% CI for the difference between these two treatments in percent change from baseline in LDL-C fell within ±3%.|Difference in Least Squares Mean|1.4|||||TWO_SIDED|95.0|0.4|2.4|||ANOVA|Factors for sequence, participant within sequence, period and treatment||||2.4|0.4|
70950817|NCT00479882|141402833|NON_INFERIORITY_OR_EQUIVALENCE|Clinical equivalence HDL-C reduction was established if the 95% CI for the difference between these two treatments in percent change from baseline in LDL-C fell within ±4%.|Difference in Least Squares Mean|-0.2|||||TWO_SIDED|95.0|-1.4|1.0|||ANOVA|Factors for sequence, participant within sequence, period and treatment||||1.0|-1.4|
70950818|NCT00479882|141402833|NON_INFERIORITY_OR_EQUIVALENCE|Clinical equivalence HDL-C reduction was established if the 95% CI for the difference between these two treatments in percent change from baseline in LDL-C fell within ±4%.|Difference in Least Squares Mean|-0.8|||||TWO_SIDED|95.0|-1.9|0.2|||ANOVA|Factors for sequence, participant within sequence, period and treatment||||0.2|-1.9|
70950819|NCT00479882|141402834|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.2||||0.685|TWO_SIDED|95.0|-1.2|0.8|||Fisher Exact||Wilson's Method|Periods I/II||0.8|-1.2|0.685
70950820|NCT00479882|141402834|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.3|||||TWO_SIDED|95.0|-1.8|1.1|||||Wilson's Method|Period III||1.1|-1.8|
70950821|NCT00479882|141402834|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.3||||0.753|TWO_SIDED|95.0|-1.6|0.9|||Fisher Exact||Wilson's Method|Periods I/II||0.9|-1.6|0.753
70868151|NCT01090492|141222401|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.09||||0.5497|TWO_SIDED|80.0|-3.45|1.26|||ANCOVA|||SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||1.26|-3.45|0.5497
70950822|NCT00479882|141402834|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2|||||TWO_SIDED|95.0|-0.8|1.4|||||Wilson's Method|Period III||1.4|-0.8|
70950823|NCT00479882|141402835|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.7|0.6|||Fisher Exact||Wilson's Method|Periods I/II||0.6|-0.7|
70950824|NCT00479882|141402835|SUPERIORITY_OR_OTHER||Difference in Percentage|0.4|||||TWO_SIDED|95.0|-0.5|1.5|||||Wilson's Method|Period III||1.5|-0.5|
70950825|NCT00479882|141402835|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2||||0.617|TWO_SIDED|95.0|-0.6|1.1|||Fisher Exact||Wilson's Method|Periods I/II||1.1|-0.6|0.617
70950826|NCT00479882|141402835|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.8|0.9|||||Wilson's Method|Period III||0.9|-0.8|
70950827|NCT00479882|141402836|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.7|0.6|||Fisher Exact||Wilson's Method|Periods I/II||0.6|-0.7|
70950828|NCT00479882|141402836|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.9|0.8|||||Wilson's Method|Period III||0.8|-0.9|
70950829|NCT00479882|141402836|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.6|0.7|||Fisher Exact||Wilson's Method|Periods I/II||0.7|-0.6|
70950830|NCT00479882|141402836|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.8|0.9|||||Wilson's Method|Period III||0.9|-0.8|
70950831|NCT00479882|141402837|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.7|0.6|||Fisher Exact||Wilson's Method|Periods I/II||0.6|-0.7|
70950832|NCT00479882|141402837|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.9|0.8|||||Wilson's Method|Period III||0.8|-0.9|
70950833|NCT00479882|141402837|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.6|0.7|||Fisher Exact||Wilson's Method|Periods I/II||0.7|-0.6|
70950834|NCT00479882|141402837|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.8|0.9|||||Wilson's Method|Period III||0.9|-0.8|
70950835|NCT00479882|141402838|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.2||||0.497|TWO_SIDED|95.0|-0.9|0.5|||Fisher Exact|||Periods I/II||0.5|-0.9|0.497
70950836|NCT00479882|141402839|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.3||||0.449|TWO_SIDED|95.0|-1.4|0.6|||Fisher Exact||Wilson's Method|Periods I/II||0.6|-1.4|0.449
70950837|NCT00479882|141402839|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.3|||||TWO_SIDED|95.0|-1.6|0.9|||||Wilson's Method|Period III||0.9|-1.6|
70950838|NCT00479882|141402839|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2||||0.685|TWO_SIDED|95.0|-0.8|1.2|||Fisher Exact||Wilson's Method|Period I/II||1.2|-0.8|0.685
70950839|NCT00479882|141402839|SUPERIORITY_OR_OTHER||Difference in Percentage|0.3|||||TWO_SIDED|95.0|-1.0|1.6|||||Wilson's Method|Period III||1.6|-1.0|
70868152|NCT01090492|141222402|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.15||||0.5909|TWO_SIDED|80.0|-0.21|0.52|||ANCOVA|||Week 4 (PRP): Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||0.52|-0.21|0.5909
70950840|NCT00479882|141402840|SUPERIORITY_OR_OTHER||Difference in Percentage|-1.2||||0.02|TWO_SIDED|95.0|-2.4|-0.2|||Fisher Exact||Wilson's Method|Periods I/II||-0.2|-2.4|0.020
70950841|NCT00479882|141402840|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.3|||||TWO_SIDED|95.0|-1.6|0.9|||||Wilson's Method|Period III||0.9|-1.6|
70950842|NCT00479882|141402840|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.5||||0.452|TWO_SIDED|95.0|-1.6|0.5|||Fisher Exact||Wilson's Method|Periods I/II||0.5|-1.6|0.452
70950843|NCT00479882|141402840|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.4|||||TWO_SIDED|95.0|-1.9|1.0|||||Wilson's Method|Period III||1.0|-1.9|
70950844|NCT00479882|141402841|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.6|0.6|||||Wilson's Method|Periods I/II||0.6|-0.6|
70950845|NCT00479882|141402841|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2|||||TWO_SIDED|95.0|-0.7|1.2|||||Wilson's Method|Period III||1.2|-0.7|
70950846|NCT00479882|141402841|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2|||||TWO_SIDED|95.0|-0.5|0.9|||||Wilson's Method|Periods I/II||0.9|-0.5|
70950847|NCT00479882|141402841|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2|||||TWO_SIDED|95.0|-0.6|1.3|||||Wilson's Method|Period III||1.3|-0.6|
70950848|NCT00479882|141402842|SUPERIORITY_OR_OTHER||Difference in Percentage|-1.4|||||TWO_SIDED|95.0|-6.6|3.8|||||Wilson's Score Method|Periods I/II||3.8|-6.6|
70950849|NCT00479882|141402842|SUPERIORITY_OR_OTHER||Difference in Percentage|-1.9|||||TWO_SIDED|95.0|-8.1|4.3|||||Wilson's Score Method|Period III||4.3|-8.1|
71142466|NCT00117637|141778607|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline) and using the baseline respiratory score as covariate.||||0.022
70868153|NCT01090492|141222402|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.77||||0.0053|TWO_SIDED|80.0|-1.12|-0.43|||ANCOVA|||Week 4 (PRP): Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||-0.43|-1.12|0.0053
70868154|NCT01090492|141222402|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.28||||0.3462|TWO_SIDED|80.0|-0.67|0.1|||ANCOVA|||Week 4 (SRP): Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||0.10|-0.67|0.3462
70868155|NCT01090492|141222402|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.44||||0.194|TWO_SIDED|80.0|-0.88|-0.01|||ANCOVA|||Week 4 (SRP): Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||-0.01|-0.88|0.1940
70950850|NCT00479882|141402842|SUPERIORITY_OR_OTHER||Difference in Percentage|0.1|||||TWO_SIDED|95.0|-5.2|5.3|||||Wilson's Score Method|Periods I/II||5.3|-5.2|
70950851|NCT00479882|141402842|SUPERIORITY_OR_OTHER||Difference in Percentage|-2.8|||||TWO_SIDED|95.0|-8.9|3.4|||||Wilson's Score Method|Period III||3.4|-8.9|
70950852|NCT00479882|141402843|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.2|||||TWO_SIDED|95.0|-2.5|2.1|||||Wilson's Score Method|Periods I/II||2.1|-2.5|
70950853|NCT00479882|141402843|SUPERIORITY_OR_OTHER||Difference in Percentage|2.3|||||TWO_SIDED|95.0|-0.5|5.2|||||Wilson's Score Method|Period III||5.2|-0.5|
70950854|NCT00479882|141402843|SUPERIORITY_OR_OTHER||Difference in Percentage|1.6|||||TWO_SIDED|95.0|-1.0|4.2|||||Wilson's Score Method|Periods I/II||4.2|-1.0|
70950855|NCT00479882|141402843|SUPERIORITY_OR_OTHER||Difference in Percentage|2.0|||||TWO_SIDED|95.0|-0.8|5.0|||||Wilson's Score Method|Period III||5.0|-0.8|
70950856|NCT00479882|141402846|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2|||||TWO_SIDED|95.0|-0.5|0.9|||||Wilson's Score Method|Periods I/II||0.9|-0.5|
70950857|NCT00479882|141402846|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.2|||||TWO_SIDED|95.0|-0.9|0.5|||||Wilson's Score Method|Periods I/II||0.5|-0.9|
70950858|NCT00479882|141402847|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.0||||0.341|TWO_SIDED|95.0|-1.1|3.1|||ANOVA|Factors for treatment, country and gender||||3.1|-1.1|0.341
70950859|NCT00479882|141402847|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|3.7||||0.004|TWO_SIDED|95.0|1.2|6.1|||ANOVA|Factors for treatment, country and gender.||||6.1|1.2|0.004
70950860|NCT00479882|141402848|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.4||||0.69|TWO_SIDED|95.0|-2.3|1.5|||ANOVA|Factors for treatment, country and gender||||1.5|-2.3|0.690
70950861|NCT00479882|141402848|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.2||||0.879|TWO_SIDED|95.0|-1.9|2.3|||ANOVA|Factors for treatment, country and gender||||2.3|-1.9|0.879
70950862|NCT03738475|141402849|SUPERIORITY|||||||0.0056||||||Based on Wilcoxon Rank Sum test for the change from baseline between treatment groups.|Wilcoxon Rank Sum test|||||||0.0056
70950863|NCT03738475|141402853|SUPERIORITY|||||||0.0799||||||Based on Wilcoxon Rank Sum test for the change from baseline between treatment groups.|Wilcoxon Rank Sum test|||||||0.0799
70950864|NCT03738475|141402855|SUPERIORITY|||||||0.289||||||Based on Wilcoxon Rank Sum test for the change from baseline between treatment groups.|Wilcoxon Rank Sum test|||||||0.2890
70950865|NCT01993849|141402904|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.69|TWO_SIDED|95.0|-3.81|2.59||The p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|t-test, 2 sided|||||2.59|-3.81|0.69
71142467|NCT00117637|141778609|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline) and using the baseline respiratory score as covariate.||||0.015
71142468|NCT00117637|141778611|SUPERIORITY_OR_OTHER|||||||0.073||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline).||||0.073
71142469|NCT00117637|141778613|SUPERIORITY_OR_OTHER|||||||0.067||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline).||||0.067
71142470|NCT00117637|141778614|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline).||||0.005
70950866|NCT03443414|141402905|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.139|||<|0.001|TWO_SIDED|95.0|0.069|0.21|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 6.0 mg - Placebo).||0.210|0.069|<0.001
71142471|NCT00117637|141778615|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline).||||0.001
70868156|NCT01768286|141222408|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||A 2-sided 1-sample binomial test was used to compare over the historical SVR12 rate of 25%. To control the family-wise type I error rate at 0.05, the Hochberg procedure was applied, from which the adjusted p-values were obtained.|Binomial test|||||||<0.001
71142472|NCT00117637|141778616|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline).||||0.019
71142473|NCT00117637|141778625|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Log Rank|||||||0.014
71142474|NCT00702468|141778657|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.335||||0.013|TWO_SIDED|90.0|0.162|0.691|||Chi-squared|||||0.691|0.162|0.013
71142475|NCT00702468|141778658|SUPERIORITY_OR_OTHER_LEGACY||Estimated treatment difference|-0.21||||0.72|TWO_SIDED|90.0|-1.22|0.79|||ANCOVA||Negative difference indicates the comparison is in favour of Sativex|||0.79|-1.22|0.720
70868157|NCT01768286|141222408|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||A 2-sided 1-sample binomial test was used to compare over the historical SVR12 rate of 25%. To control the family-wise type I error rate at 0.05, the Hochberg procedure was applied, from which the adjusted p-values were obtained.|Binomial test|||||||<0.001
71142476|NCT00702468|141778659|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|0.53||||0.86|TWO_SIDED|90.0|-4.68|5.74|||ANCOVA|||||5.74|-4.68|0.86
71142477|NCT00702468|141778661|SUPERIORITY_OR_OTHER_LEGACY||Slope|-1.78||||0.81|TWO_SIDED|90.0|-14.52|10.96|||ANCOVA||Negative difference indicates the comparison is in favour of Sativex|It is important to emphasise that only four placebo subjects were included in the analysis and 11 of the Sativex subjects - this sample size is too small for a meaningful comparison between treatments. The reason for not including some of the data in this analysis is that a number of the subjects who withdrew early from the study restarted their own Sativex before the assessment was done.||10.96|-14.52|0.81
71142478|NCT00702468|141778662|SUPERIORITY_OR_OTHER_LEGACY||treatment difference|-0.64||||0.271|TWO_SIDED|90.0|-1.6|0.33|||ANCOVA||A negative difference indicates the comparison is in favour of Sativex|||0.33|-1.60|0.271
71142479|NCT00702468|141778663|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.562||||0.017|TWO_SIDED|90.0|1.585|13.997|||Regression, Logistic|||||13.997|1.585|0.017
71142480|NCT00702468|141778664|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|18.55||||0.0011|TWO_SIDED|90.0|3.942|118.773|||Regression, Logistic|||||118.773|3.942|0.0011
71142481|NCT00702468|141778665|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.444||||0.1151|TWO_SIDED|90.0|0.948|13.718|||Regression, Logistic|||||13.718|0.948|0.1151
71142482|NCT04864249|141778695|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||||||0.54
71142483|NCT04864249|141778696|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
71142484|NCT04864249|141778697|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||||||0.89
71142485|NCT04864249|141778698|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
71142486|NCT04864249|141778699|SUPERIORITY|||||||0.15|||||||Chi-squared|||||||0.15
71142487|NCT04864249|141778700|SUPERIORITY|||||||0.84|||||||Chi-squared|||||||0.84
71142488|NCT04864249|141778701|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||0.51
71142489|NCT04864249|141778702|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
71142490|NCT04864249|141778703|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
71142491|NCT04864249|141778704|SUPERIORITY|||||||0.62|||||||t-test, 2 sided|||||||0.62
71142492|NCT04864249|141778705|SUPERIORITY|||||||0.19|||||||Chi-squared|||||||0.19
71142493|NCT04864249|141778706|SUPERIORITY|||||||0.66|||||||Chi-squared|||||||0.66
71142494|NCT04864249|141778707|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
71142495|NCT04864249|141778708|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
71142496|NCT04864249|141778709|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||||||0.56
71142497|NCT04864249|141778710|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.80
71142498|NCT04864249|141778711|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||||||0.48
71142499|NCT04864249|141778712|SUPERIORITY|||||||0.62|||||||Chi-squared|||||||0.62
71142500|NCT04864249|141778713|SUPERIORITY|||||||0.21|||||||Chi-squared|||||||0.21
71142501|NCT04864249|141778714|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
71142502|NCT04864249|141778715|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
71142503|NCT04864249|141778716|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.51
71142504|NCT04864249|141778717|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
71142505|NCT04864249|141778718|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||0.68
71142506|NCT04864249|141778719|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
71142507|NCT04864249|141778720|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||||||0.94
71142508|NCT04864249|141778721|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
71142509|NCT04864249|141778722|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
71142510|NCT04864249|141778723|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||||||0.52
71142511|NCT04864249|141778724|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
71142512|NCT04864249|141778725|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
71142513|NCT04864249|141778726|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
70868158|NCT01768286|141222408|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||A 2-sided 1-sample binomial test was used to compare over the historical SVR12 rate of 25%. To control the family-wise type I error rate at 0.05, the Hochberg procedure was applied, from which the adjusted p-values were obtained.|Binomial test|||||||<0.001
70868159|NCT01768286|141222408|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||A 2-sided 1-sample binomial test was used to compare over the historical SVR12 rate of 25%. To control the family-wise type I error rate at 0.05, the Hochberg procedure was applied, from which the adjusted p-values were obtained.|Binomial test|||||||<0.001
70868160|NCT01611155|141222423|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||||||0.87
70868161|NCT01611155|141222424|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||Motor subscale||||0.53
70868162|NCT01611155|141222424|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||autonomic subscale||||0.89
70868163|NCT02168361|141222460|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||Null hypothesis is no difference between two regimens in SVR-12.||||.02
70868164|NCT00453063|141222464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||ANCOVA|||||||0.001
70868165|NCT00453063|141222465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.304||95.0|||||ANCOVA|||||||0.304
70950867|NCT03443414|141402905|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.2|||<|0.001|TWO_SIDED|95.0|0.131|0.27|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 3.0 mg - Placebo).||0.270|0.131|<0.001
70950868|NCT03443414|141402905|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.153|||<|0.001|TWO_SIDED|95.0|0.083|0.222|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 1.5 mg - Placebo).||0.222|0.083|<0.001
70950869|NCT03443414|141402905|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.146|||<|0.001|TWO_SIDED|95.0|0.075|0.216|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 0.75 mg - Placebo).||0.216|0.075|<0.001
70950870|NCT03443414|141402906|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.002|||=|0.953|TWO_SIDED|95.0|-0.061|0.065|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 6.0 mg - Placebo).||0.065|-0.061|=0.953
70950871|NCT03443414|141402906|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.068|||=|0.032|TWO_SIDED|95.0|0.006|0.13|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 3.0 mg - Placebo).||0.130|0.006|=0.032
70950872|NCT03443414|141402906|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.009|||=|0.773|TWO_SIDED|95.0|-0.053|0.072|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 1.5 mg - Placebo).||0.072|-0.053|=0.773
70950873|NCT03443414|141402906|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.035|||=|0.272|TWO_SIDED|95.0|-0.028|0.099|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 0.75 mg - Placebo).||0.099|-0.028|=0.272
70950874|NCT03443414|141402907|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.087|||<|0.001|TWO_SIDED|95.0|0.045|0.129|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 6.0 mg - Placebo) at Day 1.||0.129|0.045|<0.001
70950875|NCT03443414|141402907|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.095|||<|0.001|TWO_SIDED|95.0|0.053|0.137|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 3.0 mg - Placebo) at Day 1.||0.137|0.053|<0.001
70950876|NCT03443414|141402907|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.07|||=|0.001|TWO_SIDED|95.0|0.028|0.112|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 1.5 mg - Placebo) at Day 1.||0.112|0.028|=0.001
70950877|NCT03443414|141402907|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.08|||<|0.001|TWO_SIDED|95.0|0.038|0.122|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 0.75 mg - Placebo) at Day 1.||0.122|0.038|<0.001
70950878|NCT03443414|141402907|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.065|||=|0.048|TWO_SIDED|95.0|0.001|0.129|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 6.0 mg - Placebo) at Week 4.||0.129|0.001|=0.048
70950879|NCT03443414|141402907|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.119|||<|0.001|TWO_SIDED|95.0|0.055|0.183|||LS mean difference|||Placebo-corrected treatment effect: LS mean difference (RPL554 3.0 mg - Placebo) at Week 4.||0.183|0.055|<0.001
70868166|NCT00453063|141222466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0|||||ANCOVA|||||||0.004
70868167|NCT00453063|141222467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.063||95.0|||||ANCOVA|||||||0.063
70868168|NCT00453063|141222468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.356||95.0|||||ANCOVA|||||||0.356
70950880|NCT03443414|141402907|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.085|||=|0.008|TWO_SIDED|95.0|0.022|0.149|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 1.5 mg - Placebo) at Week 4.||0.149|0.022|=0.008
70950881|NCT03443414|141402907|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.072|||=|0.028|TWO_SIDED|95.0|0.008|0.137|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 0.75 mg - Placebo) at Week 4.||0.137|0.008|=0.028
70950882|NCT02103114|141402924|EQUIVALENCE|T1 (Baseline)||||||0.982|||||||t-test, 2 sided|||||||0.982
70950883|NCT02103114|141402924|EQUIVALENCE|T2 (30 minutes after study drug)|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70950884|NCT02103114|141402924|EQUIVALENCE|T3 (30 minutes on CPB)||||||0.001|||||||t-test, 2 sided|||||||0.001
70950885|NCT02103114|141402924|EQUIVALENCE|T5 (Arrival in ICU)||||||0.003|||||||t-test, 2 sided|||||||0.003
70950886|NCT02103114|141402924|EQUIVALENCE|T6 (POD 2)||||||0.84|||||||t-test, 2 sided|||||||0.840
70950887|NCT02103114|141402924|EQUIVALENCE|T7 (POD 4)||||||0.475|||||||t-test, 2 sided|||||||0.475
70950888|NCT02103114|141402925|EQUIVALENCE|T4 (just prior to coming off of CPB)||||||0.048|||||||Wilcoxon (Mann-Whitney)|||||||0.048
70950889|NCT02103114|141402926|EQUIVALENCE|T1 (Baseline)||||||0.855|||||||Wilcoxon (Mann-Whitney)|||||||0.855
70950890|NCT02103114|141402926|EQUIVALENCE|T5 (Arrival in ICU)||||||0.225|||||||Wilcoxon (Mann-Whitney)|||||||0.225
70950891|NCT02103114|141402926|EQUIVALENCE|T6 (POD 2)||||||0.313|||||||Wilcoxon (Mann-Whitney)|||||||0.313
70950892|NCT02103114|141402926|EQUIVALENCE|T7 (POD 4)||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
71142514|NCT04864249|141778727|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
70950893|NCT02103114|141402929|EQUIVALENCE|T1 (Baseline) to T5 (Arrival in ICU)||||||0.056|||||||Wilcoxon (Mann-Whitney)|||||||0.056
70950894|NCT02103114|141402930|EQUIVALENCE|T1 (Baseline) to T5 (Arrival in ICU)||||||0.545|||||||Wilcoxon (Mann-Whitney)|||||||0.545
70950895|NCT02103114|141402932|EQUIVALENCE|Baseline (intraoperatively) (Time 1) to before termination of bypass (Time 4)||||||0.757|||||||Wilcoxon (Mann-Whitney)|||||||0.757
70950896|NCT02103114|141402935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2741|||||||t-test, 2 sided|24 hour postop Fresh Frozen Plasma exposures||||||0.2741
70868169|NCT04560998|141222546|SUPERIORITY||The Hodges-Lehmann estimate|1.13||||0.0004|TWO_SIDED|95.0|1.056|1.211|||Wilcoxon (Mann-Whitney)|||||1.211|1.056|0.0004
70950897|NCT02103114|141402935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0351|||||||t-test, 2 sided|24 hour postop Platelet exposures||||||0.0351
70950898|NCT02103114|141402935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073|||||||t-test, 2 sided|24 hour postop Cryoprecipitate exposures||||||0.073
70950899|NCT02103114|141402935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0196|||||||t-test, 2 sided|24 hour postop Red Blood Cell exposures||||||0.0196
70950900|NCT02103114|141402936|EQUIVALENCE|protamine time plus 24 hours||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
70950901|NCT02103114|141402938|EQUIVALENCE|24 Hours Post-Operatively||||||0.0004|||||||Fisher Exact|||||||0.0004
70950902|NCT02103114|141402939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.927|||||||t-test, 2 sided|||||||0.927
70950903|NCT02103114|141402940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.738|||||||t-test, 2 sided|||||||0.738
70950904|NCT02103114|141402941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.231|||||||Fisher Exact|||||||0.231
70950905|NCT02103114|141402942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.661|||||||Fisher Exact|||||||0.661
70950906|NCT02103114|141402944|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||||||1.0
70950907|NCT02103114|141402945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.342|||||||Fisher Exact|||||||0.342
70950908|NCT02103114|141402946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.961|||||||t-test, 2 sided|||||||0.961
70950909|NCT03933462|141402947|SUPERIORITY|"Categorical preference endpoints that answered at the final visit (e.g., Which device do you prefer?) were analyzed with a One-sample Binomial Test that compared the observed proportion to a 50/50 split."|||||<|0.001|||||||One Sample Binomial|||||||<0.001
70950910|NCT04692467|141402956|SUPERIORITY||Mean Difference (Final Values)|-5.88|||<|0.0001|TWO_SIDED|95.0|-8.77|-3.01|||Mixed Models Analysis||The mean difference reflects the difference in mean change (i.e., mean change = 12 months minus baseline for each arm) between the intervention arm and SOC arm (direction = intervention arm minus SOC arm).|||-3.01|-8.77|<0.0001
70950911|NCT00422734|141402975|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. Statistical significance at 0.05 level was required for this variable|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.||||<0.001
71142515|NCT04864249|141778728|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||||||0.09
71142516|NCT04864249|141778729|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
71142517|NCT04864249|141778730|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
71142518|NCT00300755|141778731|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group analysis of final week change from baseline.||||<0.001
71142519|NCT00300755|141778731|SUPERIORITY_OR_OTHER|||||||0.063|||||||t-test, 2 sided|||Within group analysis of final week change from baseline.||||0.063
71142520|NCT00300755|141778731|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group analysis of final week change from baseline.||||< 0.001
71142521|NCT00300755|141778731|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANCOVA|Analysis with treatment group and baseline age as fixed effects, and baseline GERD symptom score and baseline antacid use as covariates||Between group analysis of final week change from baseline.||||0.004
71142522|NCT00300755|141778731|SUPERIORITY_OR_OTHER|||||||0.082|||||||ANCOVA|Analysis with treatment group and baseline age as fixed effects, and baseline GERD symptom score and baseline antacid use as covariates||Between group analysis of final week change from baseline.||||0.082
71142523|NCT00300755|141778731|SUPERIORITY_OR_OTHER|||||||0.217|||||||ANCOVA|Analysis with treatment group and baseline age as fixed effects, and baseline GERD symptom score and baseline antacid use as covariates||Between group analysis of final week change from baseline.||||0.217
70950912|NCT00422734|141402976|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Subject. Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. To adjust for multiplicity, statistical significance at 0.025 level was required for this variable.|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.||||<0.001
70950913|NCT00422734|141402976|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Partner. Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. To adjust for multiplicity, statistical significance at 0.025 level was required for this variable.|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.||||<0.001
70950914|NCT00422734|141402977|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
71142524|NCT00300755|141778732|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Vomiting/regurgitation.||||0.002
71142525|NCT00300755|141778732|SUPERIORITY_OR_OTHER|||||||0.033|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Vomiting/regurgitation.||||0.033
71142526|NCT00300755|141778732|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Choking/gagging.||||<0.001
71142527|NCT00300755|141778732|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Choking/gagging.||||0.002
71142528|NCT00300755|141778732|SUPERIORITY_OR_OTHER|||||||0.009|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Refusal to eat.||||0.009
71142529|NCT00300755|141778732|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Difficulty swallowing.||||0.004
71142530|NCT00300755|141778732|SUPERIORITY_OR_OTHER|||||||0.044|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Difficulty swallowing.||||0.044
70868170|NCT04560998|141222547|SUPERIORITY||The Hodges-Lehmann estimate|1.08||||0.038|TWO_SIDED|95.0|1.004|1.156|||Wilcoxon (Mann-Whitney)|||||1.156|1.004|0.0380
70868171|NCT04560998|141222548|SUPERIORITY||The Hodges-Lehmann estimate|1.0||||0.0108|TWO_SIDED|95.0|0.478|1.518|||Wilcoxon (Mann-Whitney)|||||1.518|0.478|0.0108
71142531|NCT00300755|141778732|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Abdominal/belly pain.||||0.002
71142532|NCT00300755|141778732|SUPERIORITY_OR_OTHER|||||||0.026|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Abdominal/belly pain.||||0.026
71142533|NCT00300755|141778732|SUPERIORITY_OR_OTHER|||||||0.026|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Abdominal/belly pain.||||0.026
71142534|NCT00300755|141778733|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for Cough without cold.||||0.004
71142535|NCT00300755|141778733|SUPERIORITY_OR_OTHER|||||||0.047|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for Noisy breathing.||||0.047
71142536|NCT03192826|141778735|EQUIVALENCE|The SPSS statistical package version 23.0 (Statistical Package for the Social Sciences, version 23.0, SSPS Inc. Chicago, IL, USA) was used for statistical analysis.|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||ANOVA|Repeated measures ANOVA was used to compare parametric values with Bonferroni post hoc test for within group comparisons.|the reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|||||<0.05
71142537|NCT03192826|141778736|EQUIVALENCE|The SPSS statistical package version 23.0 (Statistical Package for the Social Sciences, version 23.0, SSPS Inc. Chicago, IL, USA) was used for statistical analysis.|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||ANOVA|Repeated measures ANOVA was used to compare parametric values with Bonferroni post hoc test for within group comparisons.|the reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|||||<0.05
71142538|NCT03192826|141778737|EQUIVALENCE|The SPSS statistical package version 23.0 (Statistical Package for the Social Sciences, version 23.0, SSPS Inc. Chicago, IL, USA) was used for statistical analysis.|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||ANOVA|Repeated measures ANOVA was used to compare parametric values with Bonferroni post hoc test for within group comparisons.|the reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|||||<0.05
71142539|NCT03192826|141778738|EQUIVALENCE|The SPSS statistical package version 23.0 (Statistical Package for the Social Sciences, version 23.0, SSPS Inc. Chicago, IL, USA) was used for statistical analysis.|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||ANOVA|Repeated measures ANOVA was used to compare parametric values with Bonferroni post hoc test for within group comparisons.|the reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|||||<0.05
71142540|NCT02694744|141778739|OTHER||||||||||||||||||If the 95% confidence interval for the w/out food Arm overlapped the confidence interval for the w/ food Arm, the study will conclude that there is no evidence of a statistically significant difference between treatment arms.|||
71142541|NCT02694744|141778740|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.7893|TWO_SIDED|95.0|-0.17|0.22|||ANCOVA|||Estimation of mean change in serum potassium from Baseline to week 4.||0.22|-0.17|0.7893
71142542|NCT02374164|141778806|SUPERIORITY_OR_OTHER||Point Estimate|0.72|||||TWO_SIDED|90.0|0.612|0.847|||||Ratio Fed/Fasted. Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural logarithm-transformed data. Bioequivalence was reached if the value was 0.80 to 1.25.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in the fasted and fed (high-fat meal) states.||0.847|0.612|
71142543|NCT04678115|141778829|OTHER|Power Calculation: Sample size was estimated based on the treatment condition (three-level factor) effect size on the spontaneous blink IPF measurements (0.55) after eight participants had completed the crossover using one-way analysis of variance power calculation. This led to a sample size of 12 participants with power of 0.80 and type II error of alpha 0.05. To account for possible attrition, 16 were enrolled, with 15 completing the crossover.|||||<|0.001||||||a priori threshold for statistical significance was p\<0.05|Mixed Models Analysis|||Linear mixed-effects regression was used to determine the effect of treatment condition on the spontaneous blink and resting state open IPF, with participant as random intercept. Covariates of age, gender, blink sequence, and crossover order were investigated alone, and significant (P \< 0.05) covariates were included in the final model, from which the estimated marginal means and their 95% confidence interval were reported. Hypothesis: MLP allows a more complete spontaneous blink.||||<0.001
70868172|NCT04560998|141222549|SUPERIORITY||The Hodges-Lehmann Estimate|1.11||||0.0046|TWO_SIDED|95.0|1.033|1.197|||Wilcoxon (Mann-Whitney)|||||1.197|1.033|0.0046
70950915|NCT00422734|141402978|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
70868173|NCT00739674|141222581|SUPERIORITY_OR_OTHER_LEGACY|||||||0.118||95.0|||||Fisher Exact|||||||0.118
70868174|NCT00739674|141222582|SUPERIORITY_OR_OTHER_LEGACY|||||||0.092||95.0|||||Fisher Exact|||||||0.092
70868175|NCT00739674|141222583|SUPERIORITY_OR_OTHER_LEGACY|||||||0.122||95.0|||||Fisher Exact|||||||0.122
70868176|NCT00739674|141222584|SUPERIORITY_OR_OTHER_LEGACY|||||||0.434||95.0|||||Fisher Exact|||||||0.434
70868177|NCT00739674|141222585|SUPERIORITY_OR_OTHER_LEGACY|||||||0.507||95.0|||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.||||||0.507
70868178|NCT00739674|141222586|SUPERIORITY_OR_OTHER_LEGACY|||||||0.058||95.0|||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.||||||0.058
70868179|NCT00739674|141222587|SUPERIORITY_OR_OTHER_LEGACY|||||||0.158||95.0|||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.||||||0.158
70868180|NCT00739674|141222588|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064||95.0|||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.||||||0.064
70868181|NCT00739674|141222589|SUPERIORITY_OR_OTHER_LEGACY|||||||0.262||95.0|||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.||||||0.262
70868182|NCT00739674|141222590|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026||95.0|||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.||||||0.026
70868183|NCT00739674|141222591|SUPERIORITY_OR_OTHER_LEGACY|||||||0.212||95.0|||||Log Rank|||||||0.212
70868184|NCT01594281|141222592|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-2.8||||0.0344|TWO_SIDED|95.0|-5.4|-0.2|||ANCOVA|||||-0.2|-5.4|0.0344
70868185|NCT01594281|141222592|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-1.2||||0.3809|TWO_SIDED|95.0|-3.8|1.5|||ANCOVA|||||1.5|-3.8|0.3809
70868186|NCT01594281|141222592|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|1.7||||0.2113|TWO_SIDED|95.0|-1.0|4.3|||ANCOVA|||||4.3|-1.0|0.2113
71142544|NCT04678115|141778830|OTHER|||||||0.001|||||||Mixed Models Analysis|||Hypothesis was that both devices (MLP and KFTS) would open the eye equally well, and that both would be better than sham treatment.||||0.001
70868187|NCT01594281|141222593|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-2.4||||0.0081|TWO_SIDED|95.0|-4.2|-0.6|||ANCOVA|||||-0.6|-4.2|0.0081
70872232|NCT00407797|141229711|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6743|TWO_SIDED||||||t-test, 2 sided|||Week 21: Snoring. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.6743
71142545|NCT04678115|141778831|OTHER|||||||0.001|||||||test of proportionality|||A test of proportionality was performed to determine the effect of the three treatments on the probability of the eyelid not fully closing.||||0.001
71142546|NCT01168349|141778835|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.55|||||TWO_SIDED|95.0|0.42|0.71||||||||0.71|0.42|
71142547|NCT01168349|141778838|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
71142548|NCT00988884|141778886|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.97|||<|0.001|TWO_SIDED|95.0|0.88|1.08|||ANOVA|||Anti-HPV 6||1.08|0.88|<0.001
71142549|NCT00988884|141778886|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.97|||<|0.001|TWO_SIDED|95.0|0.87|1.07|||ANOVA|||Anti-HPV 11||1.07|0.87|<0.001
71142550|NCT00988884|141778886|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.98|||<|0.001|TWO_SIDED|95.0|0.89|1.09|||ANOVA|||Anti-HPV 16||1.09|0.89|<0.001
71142551|NCT00988884|141778886|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.99|||<|0.001|TWO_SIDED|95.0|0.88|1.12|||ANOVA|||Anti-HPV 18||1.12|0.88|<0.001
71142552|NCT00988884|141778886|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|1.04|||<|0.001|TWO_SIDED|95.0|0.93|1.17|||ANOVA|||Anti-HPV 31||1.17|0.93|<0.001
71142553|NCT00988884|141778886|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.99|||<|0.001|TWO_SIDED|95.0|0.89|1.11|||ANOVA|||Anti-HPV 33||1.11|0.89|<0.001
71142554|NCT00988884|141778886|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|1.1|||<|0.001|TWO_SIDED|95.0|0.97|1.25|||ANOVA|||Anti-HPV 45||1.25|0.97|<0.001
71142555|NCT00988884|141778886|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.98|||<|0.001|TWO_SIDED|95.0|0.88|1.1|||ANOVA|||Anti-HPV 52||1.10|0.88|<0.001
71142556|NCT00988884|141778886|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.99|||<|0.001|TWO_SIDED|95.0|0.88|1.1|||ANOVA|||Anti-HPV 58||1.10|0.88|<0.001
71142557|NCT00988884|141778887|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|3.8|||<|0.001|TWO_SIDED|97.5|-1.7|9.3|||Miettinen and Nurminen|||Serogroup A||9.3|-1.7|<0.001
71142558|NCT00988884|141778887|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|-2.1|||<|0.001|TWO_SIDED|97.5|-5.4|1.1|||Miettinen and Nurminen|||Serogroup C||1.1|-5.4|<0.001
70868188|NCT01594281|141222593|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-0.3||||0.7494|TWO_SIDED|95.0|-2.0|1.5|||ANCOVA|||||1.5|-2.0|0.7494
70868189|NCT01594281|141222593|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|2.1||||0.0175|TWO_SIDED|95.0|0.4|3.9|||ANCOVA|||||3.9|0.4|0.0175
70868190|NCT01594281|141222594|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|5.5||||0.0495|TWO_SIDED|95.0|0.0|11.0|||ANCOVA|||||11.0|0.0|0.0495
70868191|NCT01594281|141222594|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|3.0||||0.2767|TWO_SIDED|95.0|-2.5|8.5|||ANCOVA|||||8.5|-2.5|0.2767
70868192|NCT01594281|141222594|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-2.5||||0.3641|TWO_SIDED|95.0|-7.9|2.9|||ANCOVA|||||2.9|-7.9|0.3641
70868193|NCT01594281|141222595|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.47||||0.4019|TWO_SIDED|95.0|0.08|2.749|||Regression, Logistic|||≥10 letters gain||2.749|0.080|0.4019
70868194|NCT01594281|141222595|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.833||||0.2772|TWO_SIDED|95.0|0.614|5.471|||Regression, Logistic|||≥5 letters gain||5.471|0.614|0.2772
70868195|NCT01594281|141222595|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.412||||0.4731|TWO_SIDED|95.0|0.55|3.622|||Regression, Logistic|||No clinically relevant change||3.622|0.55|0.4731
70868196|NCT01594281|141222595|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.35||||0.065|TWO_SIDED|95.0|0.155|1.068|||Regression, Logistic|||≥5 letters loss||1.068|0.155|0.065
70868197|NCT01594281|141222595|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.229|4.361|||Regression, Logistic|||≥10 letters loss||4.361|0.229|1.000
70868198|NCT01594281|141222595|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.314||||0.3261|TWO_SIDED|95.0|0.031|3.173|||Regression, Logistic|||≥15 letters loss||3.173|0.031|0.3261
70868199|NCT01594281|141222595|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.667||||0.668|TWO_SIDED|95.0|0.104|4.253|||Regression, Logistic|||≥10 letters gain||4.253|0.104|0.6680
70868200|NCT01594281|141222595|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|2.842||||0.0838|TWO_SIDED|95.0|0.87|9.283|||Regression, Logistic|||≥5 letters gain||9.283|0.870|0.0838
70868201|NCT01594281|141222595|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.674||||0.4116|TWO_SIDED|95.0|0.263|1.729|||Regression, Logistic|||No clinically relevant change||1.729|0.263|0.4116
70868202|NCT01594281|141222595|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.621||||0.4197|TWO_SIDED|95.0|0.195|1.977|||Regression, Logistic|||≥5 letters loss||1.977|0.195|0.4197
70868203|NCT01594281|141222595|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.419||||0.6632|TWO_SIDED|95.0|0.294|6.856|||Regression, Logistic|||≥10 letters loss||6.856|0.294|0.6632
70868204|NCT01594281|141222595|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.029||||0.9839|TWO_SIDED|95.0|0.062|17.127|||Regression, Logistic|||≥15 letters loss||17.127|0.062|0.9839
70868205|NCT01594281|141222595|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.419||||0.663|TWO_SIDED|95.0|0.294|6.858|||Regression, Logistic|||≥10 letters gain||6.858|0.294|0.6630
70868206|NCT01594281|141222595|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.55||||0.4941|TWO_SIDED|95.0|0.441|5.444||P-value was calculated as a point estimate.|Regression, Logistic|||≥5 letters gain||5.444|0.441|0.4941
70868207|NCT01594281|141222595|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.477||||0.1259|TWO_SIDED|95.0|0.185|1.231|||Regression, Logistic|||No clinically relevant change||1.231|0.185|0.1259
70868208|NCT01594281|141222595|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.773||||0.271|TWO_SIDED|95.0|0.64|4.913|||Regression, Logistic|||≥5 letters loss||4.913|0.640|0.2710
70868209|NCT01594281|141222595|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.419||||0.6632|TWO_SIDED|95.0|0.294|6.856|||Regression, Logistic|||≥10 letters loss||6.856|0.294|0.6632
70950916|NCT00422734|141402979|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for subject scores|ANCOVA|ANCOVA included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p\<0.10||||||<0.001
71142559|NCT00988884|141778887|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|2.1|||<|0.001|TWO_SIDED|97.5|-1.8|6.1|||Miettinen and Nurminen|||Serogroup Y||6.1|-1.8|<0.001
70868210|NCT01594281|141222595|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|3.282||||0.314|TWO_SIDED|95.0|0.325|33.171|||Regression, Logistic|||≥15 letters loss||33.171|0.325|0.3140
70868211|NCT01594281|141222596|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.994||||0.9918|TWO_SIDED|95.0|0.327|3.026|||Regression, Logistic|||≥ 1 class improvement from Baseline at EOCS||3.026|0.327|0.9918
70868212|NCT01594281|141222596|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.607||||0.3595|TWO_SIDED|95.0|0.209|1.765|||Regression, Logistic|||≥ 1 class improvement from Baseline at EOCS||1.765|0.209|0.3595
70868213|NCT01594281|141222596|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.611||||0.3787|TWO_SIDED|95.0|0.204|1.83|||Regression, Logistic|||≥ 1 class improvement from Baseline at EOCS||1.830|0.204|0.3787
70868214|NCT01594281|141222596|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.889||||0.9097|TWO_SIDED|95.0|0.116|6.806|||Regression, Logistic|||≥ 2 class improvement from Baseline at EOCS||6.806|0.116|0.9097
70868215|NCT01594281|141222596|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.341||||0.223|TWO_SIDED|95.0|0.06|1.925|||Regression, Logistic|||≥ 2 class improvement from Baseline at EOCS||1.925|0.060|0.2230
71142560|NCT00988884|141778887|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|-2.1|||<|0.001|TWO_SIDED|97.5|-4.7|0.3|||Miettinen and Nurminen|||Serogroup W-135||0.3|-4.7|<0.001
70868216|NCT01594281|141222596|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.383||||0.2792|TWO_SIDED|95.0|0.068|2.177|||Regression, Logistic|||≥ 2 class improvement from Baseline at EOCS||2.177|0.068|0.2792
70868217|NCT01594281|141222597|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-40.7||||0.0003|TWO_SIDED|95.0|-62.1|-19.3|||ANCOVA|||||-19.3|-62.1|0.0003
70868218|NCT01594281|141222597|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-22.9||||0.0357|TWO_SIDED|95.0|-44.2|-1.6|||ANCOVA|||||-1.6|-44.2|0.0357
70868219|NCT01594281|141222597|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|17.8||||0.1034|TWO_SIDED|95.0|-3.7|39.3|||ANCOVA|||||39.3|-3.7|0.1034
70868220|NCT01594281|141222598|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-51.7||||0.0007|TWO_SIDED|95.0|-81.1|-22.3|||ANCOVA|||||-22.3|-81.1|0.0007
70868221|NCT01594281|141222598|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-28.9||||0.0542|TWO_SIDED|95.0|-58.4|0.5|||ANCOVA|||||0.5|-58.4|0.0542
70868222|NCT01594281|141222598|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|22.8||||0.1288|TWO_SIDED|95.0|-6.7|52.3|||ANCOVA|||||52.3|-6.7|0.1288
70950917|NCT00422734|141402979|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for partner scores|ANCOVA|ANCOVA included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p\<0.10||||||<0.001
70868223|NCT01543958|141222616|SUPERIORITY_OR_OTHER|||||||0.87||||||not adjusted for multiple comparisons|Sign test|no other adjustment||||||0.87
70868224|NCT01543958|141222617|SUPERIORITY_OR_OTHER|||||||0.62||||||Not adjusted for multiple comparisons|Sign test|no other adjustment||||||0.62
70868225|NCT01945281|141222666|OTHER|Miettinen \& Nurminen method stratified by stratum (Weight category based on weight at study entry) with Cochran Mantel-Haenszel's weights.|Difference in Percentage|-0.9|||||TWO_SIDED|95.0|-24.3|27.7|||||Caspofungin minus Amphotericin|||27.7|-24.3|
70868226|NCT01945281|141222667|OTHER|Miettinen \& Nurminen method stratified by stratum (Weight category based on weight at study entry) with Cochran Mantel-Haenszel's weights.|Difference in Percentage|-6.3|||||TWO_SIDED|95.0|-30.2|22.6|||||Caspofungin minus Amphotericin|||22.6|-30.2|
70868227|NCT01519271|141222687|SUPERIORITY||Cohen's D|0.35|||||TWO_SIDED|||||||||||||
70868228|NCT02165215|141222713|SUPERIORITY||Adjusted difference in response rates|7.7||||0.1942|TWO_SIDED|95.0|-4.2|19.2|||Cochran-Mantel-Haenszel|||||19.2|-4.2|0.1942
71142561|NCT00988884|141778888|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|97.5|-0.8|0.9|||Miettinen and Nurminen|||Anti-diphtheria titer \>=0.1 IU/mL||0.9|-0.8|<0.001
71142562|NCT00988884|141778888|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|-0.2|||<|0.001|TWO_SIDED|97.5|-1.2|0.7|||Miettinen and Nurminen|||Anti-tetanus titer \>=0.1 IU/mL||0.7|-1.2|<0.001
70868229|NCT02165215|141222714|SUPERIORITY||Adjusted difference in remission rates|14.6||||0.1524|TWO_SIDED|95.0|-5.55|33.15||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||33.15|-5.55|0.1524
71142563|NCT00988884|141778889|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the fold difference is \>0.67|Fold difference in GMT|0.8||||0.003|TWO_SIDED|97.5|0.69|0.92|||ANOVA|||Anti-PT||0.92|0.69|0.003
70868230|NCT02165215|141222715|SUPERIORITY||Adjusted difference in remission rates|8.7||||0.1466|TWO_SIDED|95.0|-3.26|20.21||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||20.21|-3.26|0.1466
70868231|NCT02165215|141222716|SUPERIORITY||Adjusted difference in remission rates|10.9||||0.3083||95.0|-9.72|30.49||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||30.49|-9.72|0.3083
70868232|NCT02165215|141222717|SUPERIORITY||Adjusted difference in response rates|14.4||||0.0235|TWO_SIDED|95.0|1.84|26.28||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||26.28|1.84|0.0235
70868233|NCT02165215|141222718|SUPERIORITY||Adjusted difference in remission rates|12.8||||0.0293||95.0|1.13|23.89||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||23.89|1.13|0.0293
70868234|NCT02165215|141222719|SUPERIORITY||Adjusted difference in remission rates|19.8||||0.0075|TWO_SIDED|95.0|5.16|33.11||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||33.11|5.16|0.0075
70868235|NCT02165215|141222720|SUPERIORITY||Adjusted difference in remission rates|9.9||||0.1415||95.0|-4.47|23.13||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||23.13|-4.47|0.1415
71142564|NCT00988884|141778889|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the fold difference is \>0.67|Fold difference in GMT|0.91|||<|0.001|TWO_SIDED|97.5|0.83|1.01|||ANOVA|||Anti-FHA||1.01|0.83|<0.001
70950918|NCT00422734|141402980|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for SEP Question 2. Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. Statistical significance at 0.05 level was required for this variable.|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.||||<0.001
70950919|NCT00422734|141402980|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for SEP Question 3. Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. Statistical significance at 0.05 level was required for this variable.|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.||||<0.001
70950920|NCT00422734|141402981|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value for SEP Question 4|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
70950921|NCT00422734|141402981|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value for SEP Question 5|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
70950922|NCT00422734|141402982|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
70950923|NCT00422734|141402983|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
70950924|NCT00422734|141402984|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for GAQ Question 1|Regression, Logistic|Model included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p\<0.10||||||<0.001
70950925|NCT00422734|141402984|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for GAQ Question 2|Regression, Logistic|Model included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p\<0.10||||||<0.001
70950926|NCT00422734|141402985|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for GAQ Question 1|Regression, Logistic|Model included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p\<0.10||||||<0.001
70950927|NCT00422734|141402985|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for GAQ Question 2|Regression, Logistic|Model included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p\<0.10||||||<0.001
70950928|NCT00422734|141402986|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEP Question 1|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
70950929|NCT00422734|141402986|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEP Question 2|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
70950930|NCT00422734|141402987|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEAR Total Score|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
70950931|NCT00422734|141402987|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEAR Sexual Relationship|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
71142565|NCT00988884|141778889|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the fold difference is \>0.67|Fold difference in GMT|0.95|||<|0.001|TWO_SIDED|97.5|0.84|1.08|||ANOVA|||Anti-PRN||1.08|0.84|<0.001
70950932|NCT00422734|141402987|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEAR Confidence|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
70950933|NCT00422734|141402988|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEAR Self-Esteem|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
70950934|NCT00422734|141402988|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEAR Overall Relationship|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
70950935|NCT02078492|141403004|NON_INFERIORITY_OR_EQUIVALENCE|We assumed a minimal clinically significant difference (MCSD) of 1.3 between the three ketorolac groups at the 30-minute pain assessment and a standard deviation of 3.0. A power analysis determined that a sample of 78 subjects per group provided at least 80% power to detect an MCSD of at least 1.3 at 30 minutes with α=0.05.||||||0.783|||||||ANOVA|2 degrees of freedom||The main hypothesis was that there would be equivalence of dose effect across the three groups at every time point, and the primary comparison consisted of the pain assessment at 30 minutes.||||.783
70950936|NCT00305344|141403109|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Fisher Exact|||Null hypothesis: there will be no difference between AUC C-peptide at baseline and 1 or 2 years post cord blood infusion||||>0.05
70950937|NCT02209181|141403128|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|16.38|STANDARD_ERROR_OF_MEAN|2.522|<|0.001|TWO_SIDED|95.0|11.42|21.35||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||21.35|11.42|<0.001
70868236|NCT02165215|141222721|SUPERIORITY||Adjusted difference in remission rates|9.9||||0.1415||95.0|-4.47|23.13||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||23.13|-4.47|0.1415
70868237|NCT02165215|141222722|SUPERIORITY||Difference in Least Square Means|-2.8||||0.0266|TWO_SIDED|95.0|-5.3|-0.4||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||-0.4|-5.3|0.0266
70868238|NCT02165215|141222723|SUPERIORITY||Difference in Least Square Means|-1.2||||0.0175|TWO_SIDED|95.0|-2.2|-0.2||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||-0.2|-2.2|0.0175
70868239|NCT02165215|141222724|SUPERIORITY||Difference in Adjusted Mean|2.1||||0.6331|TWO_SIDED|95.0|-6.6|10.8||p-value has not been adjusted for multiplicity|ANCOVA|||||10.8|-6.6|0.6331
70868240|NCT04678661|141222735|SUPERIORITY|||||||0.207||||||Propensity score matching was used to form pairs of intervention and control participants. Specifically, a greedy matching procedure with a matching caliper of 0.2 of the standard deviation of the logit of the propensity score was used.|Regression, Linear|Model adjusted for covariates of age, race, baseline BMI, and baseline hemoglobin A1c.||||||.207
70868241|NCT04678661|141222736|OTHER|||||||0.011|||||||t-test, 2 sided|||Independent t-test||||.011
70868242|NCT04678661|141222737|OTHER|||||||0.024|||||||t-test, 2 sided|||||||.024
70868243|NCT04678661|141222738|OTHER|||||||0.579|||||||t-test, 2 sided|||||||.579
70868244|NCT04678661|141222739|OTHER||||||<|0.001||||||Reported p-value was calculated.|t-test, 2 sided|||||||<.001
70868245|NCT04678661|141222740|OTHER|||||||0.269|||||||t-test, 2 sided|||||||.269
70868246|NCT04678661|141222743|OTHER||||||<|0.001||||||Reported p-value was calculated.|t-test, 2 sided|||||||<.001
70868247|NCT04678661|141222744|OTHER||||||<|0.001||||||Reported p-value was calculated.|t-test, 2 sided|||||||<.001
70868248|NCT04678661|141222745|OTHER|||||||0.647|||||||t-test, 2 sided|||||||.647
70868249|NCT01397890|141222755|SUPERIORITY_OR_OTHER||Ratio|1.044||||0.0004|TWO_SIDED|95.0|1.019|1.069|||ANCOVA|multiplicative ANCOVA model with treatment and country as fixed factors and baseline value as a (log-transformed) covariate||||1.069|1.019|0.0004
70868250|NCT01397890|141222756|SUPERIORITY_OR_OTHER||Ratio|1.079|||<|0.0001|TWO_SIDED|95.0|1.057|1.102|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.102|1.057|<0.0001
70868251|NCT01397890|141222757|SUPERIORITY_OR_OTHER||Ratio|1.086|||<|0.0001|TWO_SIDED|95.0|1.062|1.111|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.111|1.062|<0.0001
70868252|NCT01397890|141222758|SUPERIORITY_OR_OTHER||Ratio|1.018||||0.057|TWO_SIDED|95.0|0.999|1.037|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.037|0.999|0.0570
70868253|NCT01397890|141222759|SUPERIORITY_OR_OTHER||Ratio|1.05|||<|0.0001|TWO_SIDED|95.0|1.033|1.067|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.067|1.033|<0.0001
70868254|NCT01397890|141222760|SUPERIORITY_OR_OTHER||Ratio|1.054|||<|0.0001|TWO_SIDED|95.0|1.036|1.073|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.073|1.036|<0.0001
70868255|NCT01397890|141222761|SUPERIORITY_OR_OTHER||Ratio|1.02||||0.1956|TWO_SIDED|95.0|0.99|1.05|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.050|0.990|0.1956
70868256|NCT01397890|141222762|SUPERIORITY_OR_OTHER||Ratio|1.062|||<|0.0001|TWO_SIDED|95.0|1.035|1.091|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.091|1.035|<0.0001
70868257|NCT01397890|141222763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.303||||0.0001|TWO_SIDED|95.0|9.904|30.702|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||30.702|9.904|0.0001
70868258|NCT01397890|141222764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.587|||<|0.0001|TWO_SIDED|95.0|7.407|19.766|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||19.766|7.407|<0.0001
70868259|NCT01397890|141222765|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.469|||<|0.0001|TWO_SIDED|95.0|10.147|24.791|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||24.791|10.147|<0.0001
70868260|NCT01397890|141222766|SUPERIORITY_OR_OTHER||Mean Difference (Net)|26.428||||0.0001|TWO_SIDED|95.0|13.463|39.393|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||39.393|13.463|0.0001
70868261|NCT01397890|141222767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.192||||0.0006|TWO_SIDED|95.0|7.491|26.894|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||26.894|7.491|0.0006
70868262|NCT01397890|141222768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.472|||<|0.0001|TWO_SIDED|95.0|10.347|26.596|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||26.596|10.347|<0.0001
70868263|NCT01397890|141222769|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.668|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.437|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.437|-0.900|<0.0001
70868264|NCT01397890|141222770|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.375|||<|0.0001|TWO_SIDED|95.0|-0.552|-0.198|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.198|-0.552|<0.0001
70868265|NCT01397890|141222771|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.551|||<|0.0001|TWO_SIDED|95.0|-0.741|-0.361|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.361|-0.741|<0.0001
70868266|NCT01397890|141222772|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.236||||0.0028|TWO_SIDED|95.0|-0.391|-0.082|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.082|-0.391|0.0028
70868267|NCT01397890|141222773|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.124||||0.0372|TWO_SIDED|95.0|-0.24|-0.007|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.007|-0.240|0.0372
70868268|NCT01397890|141222774|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.231||||0.0001|TWO_SIDED|95.0|-0.35|-0.113|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.113|-0.350|0.0001
70868269|NCT01397890|141222775|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.262|||<|0.0001|TWO_SIDED|95.0|-0.364|-0.159|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.159|-0.364|<0.0001
70868270|NCT01397890|141222776|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.143||||0.0067|TWO_SIDED|95.0|-0.246|-0.04|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.040|-0.246|0.0067
70868271|NCT01397890|141222777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.122||||0.0171|TWO_SIDED|95.0|-0.222|-0.022|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.022|-0.222|0.0171
70868272|NCT01397890|141222778|SUPERIORITY_OR_OTHER||Rate ratio|0.593||||0.0032|TWO_SIDED|95.0|0.419|0.839|||Poisson regression|Poisson regression model with treatment as a factor and the duration time in study as an offset variable morning PEF as a covariate||||0.839|0.419|0.0032
70868273|NCT01397890|141222778|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.614||||0.0167|TWO_SIDED|95.0|0.412|0.916|||Regression, Cox|Time to the first COPD exacerbation||||0.916|0.412|0.0167
70868274|NCT01397890|141222778|SUPERIORITY_OR_OTHER|||||||0.0196|||||||Log Rank|||||||0.0196
70868275|NCT04645953|141222782|SUPERIORITY|||||||0.7024|||||||ANOVA|||Null hypothesis is there was no difference between groups treated with AZ-010 (1 mg or 3 mg) and the placebo group in the mean number of vomiting/retching events in the 2 hours following. treatment. Baseline, body weight, height, body mass index, age as covariates, and the treatment group and study site as factors. All statistical tests were 2-sided with a significance value of ≤ 0.05.||||0.7024
70868276|NCT04645953|141222782|SUPERIORITY|Null hypothesis is there was no difference between groups treated with AZ-010 (1 mg or 3 mg) and the placebo group in the mean number of vomiting/retching events in the 2 hours following. treatment. Baseline, body weight, height, body mass index, age as covariates, and the treatment group and study site as factors. Patients summarized by actual treatment received. Formal statistical tests (ANOVA, when performed) were 2-sided t-tests with a significance value of 0.05.||||||0.2051|||||||ANOVA|||||||0.2051
70868277|NCT04645953|141222783|SUPERIORITY|||||||0.0504|||||||Mixed Models Analysis|||Participants were asked to rate their anxiety/panic on scale of 0-100 at each time point. The higher the number, the more intense the symptom.||||0.0504
70868278|NCT04645953|141222783|SUPERIORITY|Participants were asked to rate their anxiety/panic on scale of 0-100 at each time point. The higher the number, the more intense the symptom.||||||0.8246|||||||Mixed Models Analysis|||||||0.8246
70868279|NCT04645953|141222784|SUPERIORITY|||||||0.8299||||||Prior Episode Duration 1mg AZ-010|Mixed Models Analysis|||||||0.8299
70868280|NCT04645953|141222784|SUPERIORITY|||||||0.2346||||||Prior Episode Duration 3 mg AZ-010|Mixed Models Analysis|||||||0.2346
70868281|NCT04645953|141222784|SUPERIORITY|||||||0.3997||||||Prior Episode intensity 1mg AZ-010|Mixed Models Analysis|||||||0.3997
70868282|NCT04645953|141222784|SUPERIORITY|||||||0.3997||||||Prior Episode intensity 3mg AZ-010|Mixed Models Analysis|||||||0.3997
70868283|NCT04645953|141222785|SUPERIORITY|||||||0.3847|||||||Mantel Haenszel|||||||0.3847
70868284|NCT04645953|141222785|SUPERIORITY|||||||0.1785|||||||Mantel Haenszel|||||||0.1785
70868285|NCT04645953|141222786|SUPERIORITY|||||||0.9732|||||||Mantel Haenszel|||||||0.9732
70868286|NCT04645953|141222786|SUPERIORITY|||||||0.1471|||||||Mantel Haenszel|||||||0.1471
70868287|NCT04645953|141222787|SUPERIORITY|||||||0.1337|||||||ANOVA|||The RINVR is an 8-part questionnaire with each item scored from 0-4, for a total scoring range of 0-32. A lower score indicates less distress related to nausea, vomiting, and retching. The data shown is collected within the first 24 hours after the first at-home dose.||||0.1337
70868288|NCT04645953|141222787|SUPERIORITY|||||||0.7224|||||||ANOVA|||||||0.7224
70868289|NCT04645953|141222788|SUPERIORITY|||||||0.0504|||||||Mixed Models Analysis|||Participants were asked to rate their abdominal pain, nausea, and anxiety/panic on scale of 0-100 at each time point. The higher the number, the more intense the symptom.||||0.0504
70868290|NCT04645953|141222788|SUPERIORITY|||||||0.8246|||||||Mixed Models Analysis|||||||0.8246
70868291|NCT04645953|141222789|SUPERIORITY|||||||0.9664|||||||Mixed Models Analysis|||||||0.9664
70868292|NCT04645953|141222789|SUPERIORITY|||||||0.7919|||||||Mixed Models Analysis|||||||0.7919
70950938|NCT02209181|141403128|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.58|STANDARD_ERROR_OF_MEAN|2.503||0.068|TWO_SIDED|95.0|-0.35|9.51||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||9.51|-0.35|0.068
70950939|NCT02209181|141403128|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|16.2|STANDARD_ERROR_OF_MEAN|2.531|<|0.001|TWO_SIDED|95.0|11.21|21.18||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||21.18|11.21|<0.001
70950940|NCT02209181|141403128|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-11.81|STANDARD_ERROR_OF_MEAN|2.503|<|0.001|TWO_SIDED|95.0|-16.73|-6.88||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-6.88|-16.73|<0.001
70950941|NCT02209181|141403128|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|2.531||0.941|TWO_SIDED|95.0|-5.17|4.8||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.80|-5.17|0.941
70950942|NCT02209181|141403129|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.15||0.448|TWO_SIDED|95.0|-0.19|0.42||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.42|-0.19|0.448
71142566|NCT00988884|141778889|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the fold difference is \>0.67|Fold difference in GMT|0.96|||<|0.001|TWO_SIDED|97.5|0.76|1.21|||ANOVA|||Anti-FIM 2/3||1.21|0.76|<0.001
71142567|NCT00988884|141778892|SUPERIORITY_OR_OTHER||Difference in percentage|-0.4||||0.806|TWO_SIDED|95.0|-3.5|2.7|||Miettinen and Nurminen|||||2.7|-3.5|0.806
70950943|NCT02209181|141403129|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.15||0.618|TWO_SIDED|95.0|-0.38|0.22||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.22|-0.38|0.618
71142568|NCT00647296|141778923|SUPERIORITY||Slope|-0.606|STANDARD_ERROR_OF_MEAN|0.408||0.1385|TWO_SIDED|95.0|-1.41|0.19|||Mixed Models Analysis||placebo minus active treatment arm, positive direction represents better outcome.|||0.19|-1.41|0.1385
71142569|NCT00647296|141778923|SUPERIORITY||Slope|0.113|STANDARD_ERROR_OF_MEAN|0.39||0.7718|TWO_SIDED|95.0|-0.65|0.88|||Mixed Models Analysis||placebo minus active treatment arm, positive direction represents better outcome.|||0.88|-0.65|0.7718
71142570|NCT00647296|141778923|SUPERIORITY||Slope|0.401|STANDARD_ERROR_OF_MEAN|0.397||0.3146|TWO_SIDED|95.0|-0.38|1.18|||Mixed Models Analysis||placebo minus active treatment arm, positive direction represents better outcome.|||1.18|-0.38|0.3146
70950944|NCT02209181|141403129|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.15||0.621|TWO_SIDED|95.0|-0.23|0.38||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.38|-0.23|0.621
70950945|NCT02209181|141403129|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.15||0.207|TWO_SIDED|95.0|-0.49|0.11||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.11|-0.49|0.207
70950946|NCT02209181|141403129|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.15||0.794|TWO_SIDED|95.0|-0.34|0.26||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.26|-0.34|0.794
70950947|NCT02209181|141403130|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.34|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|0.82|1.86||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.86|0.82|<0.001
70950948|NCT02209181|141403130|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.26||0.42|TWO_SIDED|95.0|-0.3|0.72||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.72|-0.30|0.420
71142571|NCT00647296|141778924|SUPERIORITY||Slope|0.395|STANDARD_ERROR_OF_MEAN|1.536||0.7973|TWO_SIDED|95.0|-2.61|3.4|||Mixed Models Analysis||placebo minus active treatment arm, positive direction represents a better outcome.|||3.40|-2.61|0.7973
71142572|NCT00647296|141778924|SUPERIORITY||Slope|2.009|STANDARD_ERROR_OF_MEAN|1.47||0.1732|TWO_SIDED|95.0|-0.87|4.89|||Mixed Models Analysis||placebo minus active treatment arm, positive direction represents better outcome.|||4.89|-0.87|0.1732
71142573|NCT00647296|141778924|SUPERIORITY||Slope|0.451|STANDARD_ERROR_OF_MEAN|1.497||0.7635|TWO_SIDED|95.0|-2.48|3.39|||Mixed Models Analysis||placebo minus active treatment arm, positive direction represents a better outcome.|||3.39|-2.48|0.7635
71142574|NCT00647296|141778935|SUPERIORITY||Slope|0.263|STANDARD_ERROR_OF_MEAN|0.19||0.1772|TWO_SIDED|95.0|-0.12|0.64|||Mixed Models Analysis||50 mg/day minus 150 mg/day arm, negative direction represents worse outcome.|||0.64|-0.12|0.1772
71142575|NCT00647296|141778936|SUPERIORITY||Slope|-0.615|STANDARD_ERROR_OF_MEAN|0.73||0.4025|TWO_SIDED|95.0|-2.06|0.83|||Mixed Models Analysis||50 mg/day minus 300 mg/day treatment arm, negative direction represents worse outcome.|||0.83|-2.06|0.4025
71142576|NCT01787461|141778937|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.14||||0.358|TWO_SIDED|95.0|-0.16|0.44|||ANOVA|||Change at Week 24: Analysis was performed using an analysis of variance (ANOVA) model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.44|-0.16|0.358
70950949|NCT02209181|141403130|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.26||0.083|TWO_SIDED|95.0|-0.06|0.97||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.97|-0.06|0.083
70950950|NCT02209181|141403130|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.64|-0.62||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.62|-1.64|<0.001
70950951|NCT02209181|141403130|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.4|-0.37||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.37|-1.40|<0.001
70950952|NCT02209181|141403131|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.93|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|95.0|2.28|3.59||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.59|2.28|<0.001
70950953|NCT02209181|141403131|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.33||0.058|TWO_SIDED|95.0|-0.02|1.29||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.29|-0.02|0.058
70950954|NCT02209181|141403131|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.23|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|0.57|1.89||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.89|0.57|<0.001
71142577|NCT01787461|141778938|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.037||||0.568|TWO_SIDED|95.0|-0.19|0.27|||Cochran-Mantel-Haenszel|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for Glogau classification of photoaging and site.||0.27|-0.19|0.568
71142578|NCT01787461|141778939|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04||||0.797|TWO_SIDED|95.0|-0.25|0.33|||ANOVA|||Change at Week 12: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.33|-0.25|0.797
70950955|NCT02209181|141403131|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|95.0|-2.96|-1.65||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.65|-2.96|<0.001
70950956|NCT02209181|141403131|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.71|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-2.37|-1.04||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.04|-2.37|<0.001
71142579|NCT01787461|141778940|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01||||0.965|TWO_SIDED|95.0|-0.29|0.3|||ANOVA|||Change at Week 12, Fine lines/wrinkles (Periocular area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.30|-0.29|0.965
71142580|NCT01787461|141778940|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05||||0.674|TWO_SIDED|95.0|-0.2|0.3|||ANOVA|||Change at Week 12, Fine lines/wrinkles (Perioral area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.30|-0.20|0.674
71142581|NCT01787461|141778940|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.916|TWO_SIDED|95.0|-0.35|0.32|||ANOVA|||Change at Week 12, Under eye dark circles or bags: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.32|-0.35|0.916
71142582|NCT01787461|141778940|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.915|TWO_SIDED|95.0|-0.39|0.35|||ANOVA|||Change at Week 12, Mottled hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.35|-0.39|0.915
71142583|NCT01787461|141778940|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.672|TWO_SIDED|95.0|-0.4|0.26|||ANOVA|||Change at Week 12, Sallowness/yellowing: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.26|-0.40|0.672
71142584|NCT01787461|141778940|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08||||0.655|TWO_SIDED|95.0|-0.27|0.43|||ANOVA|||Change at Week 12, Roughness/texture: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.43|-0.27|0.655
70868293|NCT00002651|141222790|NON_INFERIORITY_OR_EQUIVALENCE|The overall type I error rate used is 0.05. The type II error rate is 0.10 (power = 0.9). The trial planned for a one-sided test of the hypothesis that the hazard ratio of intermittent CAD to continuous CAD is 1.2. A hazard ratio of 1.0 was used as the specific alternative in the trial size computations. Thus, rejection of the hypothesis will be evidence against the possibility that the intermittent CAD hazard ratio is larger than the continuous CAD hazard ratio by 20% or more.|Hazard Ratio (HR)|1.1||||0.15|TWO_SIDED|90.0|0.99|1.23|||Regression, Cox|||||1.23|0.99|0.15
70950957|NCT02209181|141403132|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.73|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|3.01|4.46||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.46|3.01|<0.001
70950958|NCT02209181|141403132|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|0.36||0.035|TWO_SIDED|95.0|0.06|1.49||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.49|0.06|0.035
70868294|NCT00002651|141222791|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.83||||0.09|TWO_SIDED|95.0|-0.31|3.97||The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).|t-test, 2 sided|||||3.97|-0.31|0.09
70868295|NCT00002651|141222792|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.88||||0.003|TWO_SIDED|95.0|1.0|4.76||The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).|t-test, 2 sided|||||4.76|1.00|0.003
70868296|NCT00002651|141222793|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.0|||<|0.001|TWO_SIDED|95.0|-14.0|-5.0||The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).|t-test, 2 sided|||||-5|-14|<0.001
70868297|NCT00002651|141222794|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.0||||0.04|TWO_SIDED|95.0|1.0|36.0||The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).|t-test, 2 sided|||||36|1|0.04
70868298|NCT00002651|141222795|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.32||||0.23|TWO_SIDED|95.0|-0.83|3.46||The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).|t-test, 2 sided|||||3.46|-0.83|0.23
70950959|NCT02209181|141403132|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.94|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|1.21|2.67||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.67|1.21|<0.001
70868299|NCT00304746|141222808|SUPERIORITY_OR_OTHER|||||||0.71||95.0||||For a complete presentation of the above analysis, please see the published paper presenting the full results of this study.|mixed effects linear regression analysis|||Our primary analysis of efficacy was a mixed effects linear regression analysis comparing the rate of change of score on the HAM-D during the blinded treatment phase between groups. Our model for the mean of the outcome variable included terms for treatment, time (modeled as a continuous variable), and treatment-by-time. The measure of effect was the treatment-by-time interaction, which can be interpreted as the difference in slope with respect to time, of the outcome measure.||||0.71
70868300|NCT02527161|141222825|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70950960|NCT02209181|141403132|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.96|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-3.68|-2.24||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-2.24|-3.68|<0.001
70950961|NCT02209181|141403132|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.79|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.52|-1.07||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.07|-2.52|<0.001
70868301|NCT02527161|141222826|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks KOOS Pain||||<0.0001
70868302|NCT02527161|141222826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0013|||||||ANOVA|||Change from 6 weeks to 3 months KOOS Pain||||0.0013
70868303|NCT02527161|141222826|SUPERIORITY|||||||0.3316|||||||ANOVA|||Change from 3 months to 6 months KOOS Pain||||0.3316
70868304|NCT02527161|141222826|SUPERIORITY|||||||0.3366|||||||ANOVA|||Change from 6 months to 1 year KOOS Pain||||0.3366
70868305|NCT02527161|141222826|SUPERIORITY|||||||0.9826|||||||ANOVA|||Change from 1 year to 2 year KOOS Pain||||0.9826
70868306|NCT02527161|141222826|SUPERIORITY|||||||0.9276|||||||ANOVA|||Change from 2 year to 5 year KOOS Pain||||0.9276
70868307|NCT02527161|141222827|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks KOOS Symptoms||||<0.0001
70868308|NCT02527161|141222827|SUPERIORITY|||||||0.0736|||||||ANOVA|||Change from 6 weeks to 3 months KOOS Symptoms||||0.0736
70868309|NCT02527161|141222827|SUPERIORITY|||||||0.4675|||||||ANOVA|||Change from 3 months to 6 months KOOS Symptoms||||0.4675
70868310|NCT02527161|141222827|SUPERIORITY|||||||0.0229|||||||ANOVA|||Change from 6 months to 1 year KOOS Symptoms||||0.0229
70868311|NCT02527161|141222827|SUPERIORITY|||||||0.9968|||||||ANOVA|||Change from 1 year to 2 year KOOS Symptoms||||0.9968
70868312|NCT02527161|141222827|SUPERIORITY|||||||0.7761|||||||ANOVA|||Change from 2 year to 5 year KOOS Symptoms||||0.7761
70868313|NCT02527161|141222828|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks KOOS ADL||||<0.0001
70868314|NCT02527161|141222828|SUPERIORITY|||||||0.0212|||||||ANOVA|||Change from 6 weeks to 3 months KOOS ADL||||0.0212
70868315|NCT02527161|141222828|SUPERIORITY|||||||0.7173|||||||ANOVA|||Change from 3 months to 6 months KOOS ADL||||0.7173
70868316|NCT02527161|141222828|SUPERIORITY|||||||0.1834|||||||ANOVA|||Change from 6 months to 1 year KOOS ADL||||0.1834
70868317|NCT02527161|141222828|SUPERIORITY|||||||0.9957|||||||ANOVA|||Change from 1 year to 2 year KOOS ADL||||0.9957
70868318|NCT02527161|141222828|SUPERIORITY|||||||0.9999|||||||ANOVA|||Change from 6 months to 1 year KOOS ADL||||0.9999
70868319|NCT02527161|141222829|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks KOOS S\&R||||<0.0001
70868320|NCT02527161|141222829|SUPERIORITY|||||||0.0522|||||||ANOVA|||Change from 6 weeks to 3 months KOOS S\&R||||0.0522
70868321|NCT02527161|141222829|SUPERIORITY|||||||0.1696|||||||ANOVA|||Change from 3 months to 6 months KOOS S\&R||||0.1696
70868322|NCT02527161|141222829|SUPERIORITY|||||||0.6942|||||||ANOVA|||Change from 6 months to 1 year KOOS S\&R||||0.6942
70868323|NCT02527161|141222829|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 1 year to 2 year KOOS S\&R||||>0.9999
70868324|NCT02527161|141222829|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 2 year to 5 year KOOS S\&R||||>0.9999
70868325|NCT02527161|141222830|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks KOOS QoL||||<0.0001
70868326|NCT02527161|141222830|SUPERIORITY|||||||0.0135|||||||ANOVA|||Change from 6 weeks to 3 months KOOS QoL||||0.0135
70868327|NCT02527161|141222830|SUPERIORITY|||||||0.0829|||||||ANOVA|||Change from 3 months to 6 months KOOS QoL||||0.0829
70868328|NCT02527161|141222830|SUPERIORITY|||||||0.1729|||||||ANOVA|||Change from 6 months to 1 year KOOS QoL||||0.1729
70868329|NCT02527161|141222830|SUPERIORITY|||||||0.9687|||||||ANOVA|||Change from 1 year to 2 year KOOS QoL||||0.9687
70868330|NCT02527161|141222830|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 2 year to 5 year KOOS QoL||||>0.9999
70868331|NCT02527161|141222831|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks SF-12 PCS||||<0.0001
70868332|NCT02527161|141222831|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from 6 weeks to 3 months SF-12 PCS||||<0.0001
70868333|NCT02527161|141222831|SUPERIORITY|||||||0.8189|||||||ANOVA|||Change from 3 months to 6 months SF-12 PCS||||0.8189
70868334|NCT02527161|141222831|SUPERIORITY|||||||0.9845|||||||ANOVA|||Change from 6 months to 1 year SF-12 PCS||||0.9845
70868335|NCT02527161|141222831|SUPERIORITY|||||||0.75|||||||ANOVA|||Change from 1 year to 2 year SF-12 PCS||||0.7500
71142585|NCT01787461|141778940|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.561|TWO_SIDED|95.0|-0.23|0.43|||ANOVA|||Change at Week 24, Fine lines/wrinkles(Periocular area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.43|-0.23|0.561
70868336|NCT02527161|141222831|SUPERIORITY|||||||0.1376|||||||ANOVA|||Change from 2 year to 5 year SF-12 PCS||||0.1376
70868337|NCT02527161|141222832|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 week VAS Rest||||<0.0001
70868338|NCT02527161|141222832|SUPERIORITY|||||||0.0031|||||||ANOVA|||Change from 6 weeks to 3 months VAS Rest||||0.0031
70868339|NCT02527161|141222832|SUPERIORITY|||||||0.299|||||||ANOVA|||Change from 3 months to 6 months VAS Rest||||0.2990
70868340|NCT02527161|141222832|SUPERIORITY|||||||0.9832|||||||ANOVA|||Change from 6 months to 1 year VAS Rest||||0.9832
70868341|NCT02527161|141222832|SUPERIORITY|||||||0.9991|||||||ANOVA|||Change from 1 year to 2 year VAS Rest||||0.9991
70868342|NCT02527161|141222832|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 2 year to 5 year VAS Rest||||>0.9999
70868343|NCT02527161|141222833|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks VAS Mob||||<0.0001
70868344|NCT02527161|141222833|SUPERIORITY|||||||0.0062|||||||ANOVA|||Change from 6 weeks to 3 months VAS Mob||||0.0062
70868345|NCT02527161|141222833|SUPERIORITY|||||||0.373|||||||ANOVA|||Change from 3 months to 6 months VAS Mob||||0.3730
71142586|NCT01787461|141778940|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.356|TWO_SIDED|95.0|-0.14|0.4|||ANOVA|||Change at Week 24, Fine lines/wrinkles(Perioral area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.40|-0.14|0.356
70868346|NCT02527161|141222833|SUPERIORITY|||||||0.8499|||||||ANOVA|||Change from 6 months to 1 year VAS Mob||||0.8499
70868347|NCT02527161|141222833|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 1 year to 2 year VAS Mob||||>0.9999
70868348|NCT02527161|141222833|SUPERIORITY|||||||0.9958|||||||ANOVA|||Change from 2 year to 5 year VAS Mob||||0.9958
70868349|NCT02527161|141222834|SUPERIORITY|||||||0.3493|||||||ANOVA|||Change from preoperative to 6 weeks SF-12 MCS||||0.3493
70868350|NCT02527161|141222834|SUPERIORITY|||||||0.48|||||||ANOVA|||Change from 6 weeks to 3 months SF-12 MCS||||0.4800
70868351|NCT02527161|141222834|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 3 months to 6 months SF-12 MCS||||>0.9999
70868352|NCT02527161|141222834|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 6 months to 1 year SF-12 MCS||||>0.9999
70868353|NCT02527161|141222834|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 1 year to 2 year SF-12 MCS||||>0.9999
70868354|NCT02527161|141222834|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 2 year to 5 year SF-12 MCS||||>0.9999
71142587|NCT01787461|141778940|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08||||0.669|TWO_SIDED|95.0|-0.28|0.43|||ANOVA|||Change at Week 24, Under eye dark circles or bags: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.43|-0.28|0.669
70868355|NCT02527161|141222835|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks KSS Pain||||<0.0001
70868356|NCT02527161|141222835|SUPERIORITY|||||||0.9465|||||||ANOVA|||Change from 3 months to 6 months KSS Pain||||0.9465
70868357|NCT02527161|141222835|SUPERIORITY|||||||0.1215|||||||ANOVA|||Change from 6 months to 1 year KSS Pain||||0.1215
70868358|NCT02527161|141222835|SUPERIORITY|||||||0.9912|||||||ANOVA|||Change from 1 year to 2 years KSS Pain||||0.9912
70868359|NCT02527161|141222835|SUPERIORITY|||||||0.8952|||||||ANOVA|||Change from 2 year to 5 year KSS Pain||||0.8952
70868360|NCT02527161|141222836|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 3 months KSS Function||||<0.0001
70868361|NCT02527161|141222836|SUPERIORITY|||||||0.0266|||||||ANOVA|||Change from 3 months to 6 months KSS Function||||0.0266
70868362|NCT02527161|141222836|SUPERIORITY|||||||0.988|||||||ANOVA|||Change from 6 months to 1 year KSS Function||||0.9880
70868363|NCT02527161|141222836|SUPERIORITY|||||||0.9699|||||||ANOVA|||Change from 1 year to 2 years KSS Function||||0.9699
70868364|NCT02527161|141222836|SUPERIORITY|||||||0.8575|||||||ANOVA|||Change from 2 year to 5 years KSS Function||||0.8575
70868365|NCT02527161|141222837|SUPERIORITY|||||||0.8581|||||||ANOVA|||Change from preoperative to 3 months KSS Range of Motion||||0.8581
70868366|NCT02527161|141222837|SUPERIORITY|||||||0.7664|||||||ANOVA|||Change from 3 months to 6 months KSS Range of Motion||||0.7664
70868367|NCT02527161|141222837|SUPERIORITY|||||||0.7022|||||||ANOVA|||Change from 6 months to 1 year KSS Range of Motion||||0.7022
70868368|NCT02527161|141222837|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 1 year to 2 year KSS Range of Motion||||>0.9999
70868369|NCT02527161|141222837|SUPERIORITY|||||||0.2943|||||||ANOVA|||Change from 2 year to 5 year KSS Range of Motion||||0.2943
70868370|NCT02527161|141222838|SUPERIORITY|||||||0.0161|||||||ANOVA|||Change from 1 year to 2 year Forgotten Joint Score||||0.0161
70868371|NCT02527161|141222838|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from 2 year to 5 year Forgotten Joint Score||||<0.0001
70868372|NCT02100514|141222852|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-49.9|STANDARD_ERROR_OF_MEAN|2.09|<|0.001|TWO_SIDED|95.0|-54.0|-45.8|||MMRM|||Least square (LS) mean difference and associated 95% confidence interval (CI), and p-value were derived from an mixed effect model repeat measurement (MMRM) model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-45.8|-54.0|<0.001
71142588|NCT01787461|141778940|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01||||0.954|TWO_SIDED|95.0|-0.32|0.34|||ANOVA|||Change at Week 24, Mottled hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.34|-0.32|0.954
71142589|NCT01787461|141778940|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06||||0.684|TWO_SIDED|95.0|-0.34|0.22|||ANOVA|||Change at Week 24, Sallowness/yellowing: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.22|-0.34|0.684
70868373|NCT02100514|141222853|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-33.2|STANDARD_ERROR_OF_MEAN|1.48|<|0.001|TWO_SIDED|95.0|-36.1|-30.2|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-30.2|-36.1|<0.001
70868374|NCT02100514|141222853|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-29.6|STANDARD_ERROR_OF_MEAN|1.66|||TWO_SIDED|95.0|-32.8|-26.3||||||Week 24: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-26.3|-32.8|
70868375|NCT02100514|141222853|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-23.8|STANDARD_ERROR_OF_MEAN|1.65|||TWO_SIDED|95.0|-27.0|-20.5||||||Week 52: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-20.5|-27.0|
70868376|NCT02100514|141222854|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-45.7|STANDARD_ERROR_OF_MEAN|2.04|<|0.001|TWO_SIDED|95.0|-49.7|-41.7|||MMRM|||Week 12: LS mean difference and associated 95% CI, and p-value were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-41.7|-49.7|<0.001
70868377|NCT02100514|141222854|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-40.9|STANDARD_ERROR_OF_MEAN|2.26|||TWO_SIDED|95.0|-45.3|-36.5||||||Week 24: LS mean difference and associated 95% CI, were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-36.5|-45.3|
70868378|NCT02100514|141222854|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-32.5|STANDARD_ERROR_OF_MEAN|2.17|||TWO_SIDED|95.0|-36.7|-28.2||||||Week 52: LS mean difference and associated 95% CI, were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-28.2|-36.7|
70868379|NCT02100514|141222855|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-45.0|STANDARD_ERROR_OF_MEAN|1.99|<|0.001|TWO_SIDED|95.0|-48.9|-41.1|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-41.1|-48.9|<0.001
70872233|NCT00407797|141229711|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4736|TWO_SIDED||||||t-test, 2 sided|||LOCF: Snoring. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.4736
71142590|NCT01787461|141778940|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.886|TWO_SIDED|95.0|-0.35|0.3|||ANOVA|||Change at Week 24, Roughness/texture: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.30|-0.35|0.886
71142591|NCT01787461|141778941|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.901|TWO_SIDED|95.0|-0.33|0.37|||ANOVA|||Change at Week 12, Decolletage-Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.37|-0.33|0.901
71142592|NCT01787461|141778941|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14||||0.399|TWO_SIDED|95.0|-0.19|0.47|||ANOVA|||Change at Week 12, Decolletage-Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.47|-0.19|0.399
70950962|NCT02209181|141403133|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.99|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|3.21|4.77||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.77|3.21|<0.001
70950963|NCT02209181|141403133|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.86|STANDARD_ERROR_OF_MEAN|0.39||0.028|TWO_SIDED|95.0|0.09|1.64||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.64|0.09|0.028
70950964|NCT02209181|141403133|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.48|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|1.7|3.26||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.26|1.70|<0.001
70950965|NCT02209181|141403133|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.12|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-3.9|-2.35||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-2.35|-3.90|<0.001
70950966|NCT02209181|141403133|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.51|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.29|-0.73||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.73|-2.29|<0.001
70950967|NCT02209181|141403134|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.78|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED|95.0|2.92|4.65||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.65|2.92|<0.001
70950968|NCT02209181|141403134|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.02|STANDARD_ERROR_OF_MEAN|0.44||0.021|TWO_SIDED|95.0|0.16|1.88||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.88|0.16|0.021
70950969|NCT02209181|141403134|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.06|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED|95.0|2.19|3.93||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.93|2.19|<0.001
70950970|NCT02209181|141403134|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.77|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED|95.0|-3.63|-1.91||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.91|-3.63|<0.001
71142593|NCT01787461|141778941|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.875|TWO_SIDED|95.0|-0.38|0.32|||ANOVA|||Change at Week 12, Back of Hands-Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.32|-0.38|0.875
70950971|NCT02209181|141403134|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.44||0.104|TWO_SIDED|95.0|-1.59|0.15||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.15|-1.59|0.104
70950972|NCT02209181|141403135|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.13|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|2.18|4.07||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.07|2.18|<0.001
70950973|NCT02209181|141403135|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.98|STANDARD_ERROR_OF_MEAN|0.48||0.041|TWO_SIDED|95.0|0.04|1.92||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.92|0.04|0.041
71142594|NCT01787461|141778941|SUPERIORITY_OR_OTHER||LS Mean Difference|0.43||||0.005|TWO_SIDED|95.0|0.13|0.73|||ANOVA|||Change at Week 12, Back of Hands-Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.73|0.13|0.005
71142595|NCT01787461|141778941|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.876|TWO_SIDED|95.0|-0.33|0.38|||ANOVA|||Change at Week 24, Decolletage-Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.38|-0.33|0.876
71142596|NCT01787461|141778941|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05||||0.789|TWO_SIDED|95.0|-0.29|0.38|||ANOVA|||Change at Week 24, Decolletage-Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.38|-0.29|0.789
71142597|NCT01787461|141778941|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04||||0.901|TWO_SIDED|95.0|-0.31|0.38|||ANOVA|||Change at Week 24, Back of Hands- Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.38|-0.31|0.901
71142598|NCT01787461|141778941|SUPERIORITY_OR_OTHER||LS Mean Difference|0.38||||0.027|TWO_SIDED|95.0|0.04|0.72|||ANOVA|||Change at Week 24, Back of Hands - Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.72|0.04|0.027
71142599|NCT01787461|141778942|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.083||||0.688|TWO_SIDED|95.0|-0.1|0.27|||Cochran-Mantel-Haenszel|||Improvement Week 12, Overall appearance of facial skin: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.27|-0.10|0.688
70950974|NCT02209181|141403135|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.14|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|2.19|4.09||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.09|2.19|<0.001
70950975|NCT02209181|141403135|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.15|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|-3.09|-1.21||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.21|-3.09|<0.001
70950976|NCT02209181|141403135|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.48||0.973|TWO_SIDED|95.0|-0.93|0.97||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.97|-0.93|0.973
70950977|NCT02209181|141403136|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.87|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.87|3.87||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.87|1.87|<0.001
70950978|NCT02209181|141403136|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.89|STANDARD_ERROR_OF_MEAN|0.5||0.079|TWO_SIDED|95.0|-0.1|1.88||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.88|-0.10|0.079
70950979|NCT02209181|141403136|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.27|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|2.27|4.27||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.27|2.27|<0.001
70950980|NCT02209181|141403136|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.99|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-2.98|-1.0||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.00|-2.98|<0.001
70950981|NCT02209181|141403136|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.51||0.44|TWO_SIDED|95.0|-0.61|1.4||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.40|-0.61|0.440
70950982|NCT02209181|141403137|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.55|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|1.52|3.57||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.57|1.52|<0.001
70950983|NCT02209181|141403137|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.81|STANDARD_ERROR_OF_MEAN|0.52||0.118|TWO_SIDED|95.0|-0.21|1.83||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.83|-0.21|0.118
70950984|NCT02209181|141403137|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.13|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|2.1|4.16||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.16|2.10|<0.001
70950985|NCT02209181|141403137|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.73|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|-2.75|-0.71||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.71|-2.75|<0.001
70950986|NCT02209181|141403137|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.52||0.262|TWO_SIDED|95.0|-0.44|1.62||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.62|-0.44|0.262
70950987|NCT02209181|141403138|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.92|STANDARD_ERROR_OF_MEAN|0.53|<|0.001|TWO_SIDED|95.0|0.88|2.96||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.96|0.88|<0.001
70950988|NCT02209181|141403138|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.52||0.271|TWO_SIDED|95.0|-0.45|1.61||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.61|-0.45|0.271
71142600|NCT01787461|141778942|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.121||||0.445|TWO_SIDED|95.0|-0.08|0.33|||Cochran-Mantel-Haenszel|||Improvement Week 12, Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.33|-0.08|0.445
71142601|NCT01787461|141778942|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.205||||0.318|TWO_SIDED|95.0|0.01|0.4|||Cochran-Mantel-Haenszel|||Improvement Week 12, Under eye dark circles or bags: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.40|0.01|0.318
71142602|NCT01787461|141778942|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.012||||0.633|TWO_SIDED|95.0|-0.15|0.12|||Cochran-Mantel-Haenszel|||Improvement Week 12, Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.12|-0.15|0.633
71142603|NCT01787461|141778942|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.018||||0.996|TWO_SIDED|95.0|-0.23|0.19|||Cochran-Mantel-Haenszel|||Improvement Week 12, Complexion/Glow: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.19|-0.23|0.996
70950989|NCT02209181|141403138|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.95|STANDARD_ERROR_OF_MEAN|0.53|<|0.001|TWO_SIDED|95.0|1.91|3.99||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.99|1.91|<0.001
70950990|NCT02209181|141403138|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.52||0.011|TWO_SIDED|95.0|-2.37|-0.32||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.32|-2.37|0.011
70950991|NCT02209181|141403138|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.03|STANDARD_ERROR_OF_MEAN|0.53||0.052|TWO_SIDED|95.0|-0.01|2.07||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.07|-0.01|0.052
70950992|NCT02209181|141403139|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.25|STANDARD_ERROR_OF_MEAN|0.53||0.018|TWO_SIDED|95.0|0.21|2.29||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.29|0.21|0.018
70950993|NCT02209181|141403139|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.52||0.31|TWO_SIDED|95.0|-0.5|1.56||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.56|-0.50|0.310
70950994|NCT02209181|141403139|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|0.53|<|0.001|TWO_SIDED|95.0|1.76|3.85||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.85|1.76|<0.001
71142604|NCT01787461|141778942|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.059||||0.432|TWO_SIDED|95.0|-0.13|0.25|||Cochran-Mantel-Haenszel|||Improvement Week 12, Smoothness: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.25|-0.13|0.432
71142605|NCT01787461|141778942|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.03||||0.833|TWO_SIDED|95.0|-0.13|0.19|||Cochran-Mantel-Haenszel|||Improvement Week 24, Overall appearance of facial skin: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.19|-0.13|0.833
70950995|NCT02209181|141403139|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.52||0.172|TWO_SIDED|95.0|-1.75|0.31||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.31|-1.75|0.172
71142606|NCT01787461|141778942|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.226||||0.171|TWO_SIDED|95.0|0.06|0.39|||Cochran-Mantel-Haenszel|||Improvement Week 24, Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.39|0.06|0.171
71142607|NCT01787461|141778942|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.02||||0.796|TWO_SIDED|95.0|-0.16|0.12|||Cochran-Mantel-Haenszel|||Improvement Week 24, Under eye dark circles or bags: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.12|-0.16|0.796
70950996|NCT02209181|141403139|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.55|STANDARD_ERROR_OF_MEAN|0.53||0.004|TWO_SIDED|95.0|0.51|2.6||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.60|0.51|0.004
71142608|NCT01787461|141778942|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.033||||0.942|TWO_SIDED|95.0|-0.23|0.16|||Cochran-Mantel-Haenszel|||Improvement Week 24, Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.16|-0.23|0.942
71142609|NCT01787461|141778942|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.118||||0.405|TWO_SIDED|95.0|-0.05|0.28|||Cochran-Mantel-Haenszel|||Improvement Week 24, Complexion/Glow: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.28|-0.05|0.405
71142610|NCT01787461|141778942|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.061||||0.687|TWO_SIDED|95.0|-0.14|0.26|||Cochran-Mantel-Haenszel|||Improvement Week 24, Smoothness: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.26|-0.14|0.687
70950997|NCT02209181|141403140|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.84|STANDARD_ERROR_OF_MEAN|0.51||0.102|TWO_SIDED|95.0|-0.17|1.84||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.84|-0.17|0.102
71142611|NCT01787461|141778943|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.384||||0.017|TWO_SIDED|95.0|0.23|0.54|||Cochran-Mantel-Haenszel|||Improvement Week 12, Decolletage-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.54|0.23|0.017
71142612|NCT01787461|141778943|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.248||||0.073|TWO_SIDED|95.0|0.09|0.4|||Cochran-Mantel-Haenszel|||Improvement Week 12, Decolletage-Wrinkling/crinkling: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.40|0.09|0.073
71142613|NCT01787461|141778943|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.057||||0.117|TWO_SIDED|95.0|-0.11|0.22|||Cochran-Mantel-Haenszel|||Improvement Week 12, Decolletage-Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.22|-0.11|0.117
71142614|NCT01787461|141778943|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.096||||0.662|TWO_SIDED|95.0|-0.31|0.12|||Cochran-Mantel-Haenszel|||Improvement Week 12, Back of Hands-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.12|-0.31|0.662
71142615|NCT01787461|141778943|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.1||||0.373|TWO_SIDED|95.0|-0.05|0.25|||Cochran-Mantel-Haenszel|||Improvement Week 12, Back of Hands - Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.25|-0.05|0.373
71142616|NCT01787461|141778943|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.031||||0.294|TWO_SIDED|95.0|-0.19|0.12|||Cochran-Mantel-Haenszel|||Improvement Week 12, Back of Hands - Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.12|-0.19|0.294
70868380|NCT02100514|141222855|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-40.5|STANDARD_ERROR_OF_MEAN|2.21|||TWO_SIDED|95.0|-44.8|-36.1||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-36.1|-44.8|
71142617|NCT01787461|141778943|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.035||||0.857|TWO_SIDED|95.0|-0.2|0.13|||Cochran-Mantel-Haenszel|||Improvement Week 12, Body - Dryness Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.13|-0.20|0.857
71142618|NCT01787461|141778943|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.206||||0.088|TWO_SIDED|95.0|0.02|0.39|||Cochran-Mantel-Haenszel|||Improvement Week 24, Decolletage-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.39|0.02|0.088
71142619|NCT01787461|141778943|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.193||||0.11|TWO_SIDED|95.0|-0.02|0.41|||Cochran-Mantel-Haenszel|||Improvement Week 24, Decolletage-Wrinkling/crinkling: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.41|-0.02|0.110
71142620|NCT01787461|141778943|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.205||||0.112|TWO_SIDED|95.0|0.07|0.34|||Cochran-Mantel-Haenszel|||Improvement Week 24, Decolletage-Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.34|0.07|0.112
70950998|NCT02209181|141403140|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.51||0.479|TWO_SIDED|95.0|-0.64|1.35||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.35|-0.64|0.479
70950999|NCT02209181|141403140|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.85|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.85|3.86||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.86|1.85|<0.001
70951000|NCT02209181|141403140|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.51||0.345|TWO_SIDED|95.0|-1.47|0.52||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.52|-1.47|0.345
70951001|NCT02209181|141403140|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.01|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.01|3.02||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.02|1.01|<0.001
70951002|NCT02209181|141403141|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|0.51||0.338|TWO_SIDED|95.0|-0.52|1.51||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.51|-0.52|0.338
70951003|NCT02209181|141403141|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.51||0.299|TWO_SIDED|95.0|-0.47|1.54||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.54|-0.47|0.299
70951004|NCT02209181|141403141|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.72|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|1.7|3.73||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.73|1.70|<0.001
70951005|NCT02209181|141403141|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.51||0.942|TWO_SIDED|95.0|-0.97|1.04||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.04|-0.97|0.942
70951006|NCT02209181|141403141|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.22|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|1.21|3.24||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.24|1.21|<0.001
70951007|NCT02209181|141403142|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.51||0.306|TWO_SIDED|95.0|-0.48|1.53||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.53|-0.48|0.306
70951008|NCT02209181|141403142|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|0.51||0.335|TWO_SIDED|95.0|-0.51|1.49||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.49|-0.51|0.335
70951009|NCT02209181|141403142|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.79|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.78|3.8||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.80|1.78|<0.001
70951010|NCT02209181|141403142|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.51||0.946|TWO_SIDED|95.0|-1.03|0.97||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.97|-1.03|0.946
70872234|NCT00407797|141229711|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8173|TWO_SIDED||||||t-test, 2 sided|||Week 21: Awaken Short of Breath. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.8173
70951011|NCT02209181|141403142|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.27|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.25|3.28||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.28|1.25|<0.001
70951012|NCT02209181|141403143|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.51||0.279|TWO_SIDED|95.0|-0.45|1.56||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.56|-0.45|0.279
70951013|NCT02209181|141403143|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.54|STANDARD_ERROR_OF_MEAN|0.51||0.292|TWO_SIDED|95.0|-0.46|1.53||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.53|-0.46|0.292
70951014|NCT02209181|141403143|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.67|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.66|3.68||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.68|1.66|<0.001
71142621|NCT01787461|141778943|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.003||||0.614|TWO_SIDED|95.0|-0.13|0.13|||Cochran-Mantel-Haenszel|||Improvement Week 24, Back of Hands-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.13|-0.13|0.614
70868381|NCT02100514|141222855|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-32.7|STANDARD_ERROR_OF_MEAN|2.2|||TWO_SIDED|95.0|-37.0|-28.4||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-28.4|-37.0|
70868382|NCT02100514|141222856|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-51.6|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|-56.7|-46.6|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-46.6|-56.7|<0.001
71142622|NCT01787461|141778943|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.011||||0.693|TWO_SIDED|95.0|-0.18|0.16|||Cochran-Mantel-Haenszel|||Improvement Week 24, Back of Hands - Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.16|-0.18|0.693
70868383|NCT02100514|141222856|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-46.4|STANDARD_ERROR_OF_MEAN|2.94|||TWO_SIDED|95.0|-52.2|-40.6||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-40.6|-52.2|
70868384|NCT02100514|141222856|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-37.4|STANDARD_ERROR_OF_MEAN|3.03|||TWO_SIDED|95.0|-43.3|-31.4||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-31.4|-43.3|
70872235|NCT00407797|141229711|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9092|TWO_SIDED||||||t-test, 2 sided|||LOCF: Awaken Short of Breath. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.9092
71142623|NCT01787461|141778943|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.079||||0.762|TWO_SIDED|95.0|-0.06|0.22|||Cochran-Mantel-Haenszel|||Improvement Week 24, Back of Hands - Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.22|-0.06|0.762
71142624|NCT01787461|141778943|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.013||||0.662|TWO_SIDED|95.0|-0.16|0.13|||Cochran-Mantel-Haenszel|||Improvement Week 24, Body - Dryness Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.13|-0.16|0.662
71142625|NCT01787461|141778944|SUPERIORITY_OR_OTHER||LS Mean Difference|3.93||||0.587|TWO_SIDED|95.0|-10.32|18.18|||ANOVA|||Change at Week 6, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||18.18|-10.32|0.587
71142626|NCT01787461|141778944|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.08||||0.814|TWO_SIDED|95.0|-14.49|12.32|||ANOVA|||Change at Week 12, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||12.32|-14.49|0.814
70951015|NCT02209181|141403143|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.51||0.971|TWO_SIDED|95.0|-1.02|0.98||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.98|-1.02|0.971
70951016|NCT02209181|141403143|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.11|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.11|3.12||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.12|1.11|<0.001
70951017|NCT02209181|141403144|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.51||0.329|TWO_SIDED|95.0|-0.5|1.5||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.50|-0.50|0.329
70951018|NCT02209181|141403144|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.5||0.531|TWO_SIDED|95.0|-0.68|1.31||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.31|-0.68|0.531
70951019|NCT02209181|141403144|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.53|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.53|3.54||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.54|1.53|<0.001
70951020|NCT02209181|141403144|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.5||0.722|TWO_SIDED|95.0|-1.17|0.81||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.81|-1.17|0.722
71142627|NCT01787461|141778944|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.57||||0.453|TWO_SIDED|95.0|-16.14|8.99|||ANOVA|||Change at Week 18, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||8.99|-16.14|0.453
71142628|NCT01787461|141778944|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.16||||0.191|TWO_SIDED|95.0|-22.92|4.61|||ANOVA|||Change at Week 24, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||4.61|-22.92|0.191
71142629|NCT01787461|141778944|SUPERIORITY_OR_OTHER||LS Mean Difference|2.61||||0.685|TWO_SIDED|95.0|-10.07|15.28|||ANOVA|||Change at Week 6, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||15.28|-10.07|0.685
71142630|NCT01787461|141778944|SUPERIORITY_OR_OTHER||LS Mean Difference|5.74||||0.48|TWO_SIDED|95.0|-11.67|23.15|||ANOVA|||Change at Week 12, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||23.15|-11.67|0.480
71142631|NCT01787461|141778944|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.98||||0.299|TWO_SIDED|95.0|-17.29|5.34|||ANOVA|||Change at Week 18, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||5.34|-17.29|0.299
71142632|NCT01787461|141778944|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.07||||0.107|TWO_SIDED|95.0|-20.04|1.9|||ANOVA|||Change at Week 24, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||1.90|-20.04|0.107
71142633|NCT01787461|141778944|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.82||||0.776|TWO_SIDED|95.0|-14.39|10.76|||ANOVA|||Change at Week 6, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||10.76|-14.39|0.776
70872236|NCT00407797|141229711|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1091|TWO_SIDED||||||t-test, 2 sided|||Week 21: Sleep Adequacy. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.1091
70951021|NCT02209181|141403144|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.04|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.03|3.04||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.04|1.03|<0.001
71142634|NCT01787461|141778944|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.33||||0.603|TWO_SIDED|95.0|-15.96|9.29|||ANOVA|||Change at Week 12, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||9.29|-15.96|0.603
71142635|NCT01787461|141778944|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.82||||0.51|TWO_SIDED|95.0|-15.23|7.6|||ANOVA|||Change at Week 18, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||7.60|-15.23|0.510
71142636|NCT01787461|141778944|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.75||||0.225|TWO_SIDED|95.0|-17.7|4.2|||ANOVA|||Change at Week 24, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||4.20|-17.70|0.225
70951022|NCT02209181|141403145|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.5||0.38|TWO_SIDED|95.0|-0.54|1.42||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.42|-0.54|0.380
70951023|NCT02209181|141403145|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.49||0.767|TWO_SIDED|95.0|-0.83|1.12||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.12|-0.83|0.767
70868385|NCT02100514|141222857|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-46.6|STANDARD_ERROR_OF_MEAN|3.59|<|0.001||95.0|-53.7|-39.5|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-39.5|-53.7|<0.001
70868386|NCT02100514|141222857|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-39.7|STANDARD_ERROR_OF_MEAN|4.12||||95.0|-47.9|-31.6||||||Week 24: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-31.6|-47.9|
70868387|NCT02100514|141222857|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-33.4|STANDARD_ERROR_OF_MEAN|4.02||||95.0|-41.3|-25.5||||||Week 52: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-25.5|-41.3|
70868388|NCT02100514|141222858|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-30.8|STANDARD_ERROR_OF_MEAN|3.14|<|0.001||95.0|-36.9|-24.6|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-24.6|-36.9|<0.001
70868389|NCT02100514|141222858|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-27.5|STANDARD_ERROR_OF_MEAN|3.23||||95.0|-33.9|-21.2||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-21.2|-33.9|
70868390|NCT02100514|141222858|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-49.4|STANDARD_ERROR_OF_MEAN|18.27|||TWO_SIDED|95.0|-85.2|-13.5||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-13.5|-85.2|
70951024|NCT02209181|141403145|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|1.52|3.49||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.49|1.52|<0.001
70951025|NCT02209181|141403145|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.49||0.557|TWO_SIDED|95.0|-1.27|0.68||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.68|-1.27|0.557
71142637|NCT01787461|141778945|SUPERIORITY_OR_OTHER||LS Mean Difference|0.78||||0.214|TWO_SIDED|95.0|-0.46|2.02|||ANOVA|||Change at Week 6, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||2.02|-0.46|0.214
70868391|NCT02100514|141222859|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|5.5|STANDARD_ERROR_OF_MEAN|1.06|<|0.001|TWO_SIDED|95.0|3.4|7.6|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||7.6|3.4|<0.001
70868392|NCT02100514|141222859|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|5.4|STANDARD_ERROR_OF_MEAN|1.14||||95.0|3.2|7.6||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||7.6|3.2|
70868393|NCT02100514|141222859|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|6.0|STANDARD_ERROR_OF_MEAN|1.2||||95.0|3.6|8.3||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||8.3|3.6|
70868394|NCT02100514|141222860|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-44.2|STANDARD_ERROR_OF_MEAN|2.39||||95.0|-48.8|-39.5||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-39.5|-48.8|
70868395|NCT02100514|141222860|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-36.2|STANDARD_ERROR_OF_MEAN|2.42|||TWO_SIDED|95.0|-40.9|-31.4||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-31.4|-40.9|
70868396|NCT02100514|141222861|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-10.1|STANDARD_ERROR_OF_MEAN|2.55||||95.0|-15.1|-5.1||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-5.1|-15.1|
70868397|NCT02100514|141222861|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-9.0|STANDARD_ERROR_OF_MEAN|4.5||||95.0|-17.9|-0.2||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.2|-17.9|
70951026|NCT02209181|141403145|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.06|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|1.08|3.05||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.05|1.08|<0.001
70951027|NCT02209181|141403146|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.55||0.64|TWO_SIDED|95.0|-0.83|1.35||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.35|-0.83|0.640
70951028|NCT02209181|141403146|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.55||0.798|TWO_SIDED|95.0|-0.94|1.22||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.22|-0.94|0.798
70951029|NCT02209181|141403146|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.32|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|1.23|3.42||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.42|1.23|<0.001
70951030|NCT02209181|141403146|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.55||0.829|TWO_SIDED|95.0|-1.2|0.96||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.96|-1.20|0.829
70951031|NCT02209181|141403146|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.06|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|0.97|3.16||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.16|0.97|<0.001
70951032|NCT02209181|141403147|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.16||0.117|TWO_SIDED|95.0|-0.06|0.57||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.57|-0.06|0.117
70951033|NCT02209181|141403147|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.687|TWO_SIDED|95.0|-0.25|0.38||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.38|-0.25|0.687
70951034|NCT02209181|141403147|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.16||0.497|TWO_SIDED|95.0|-0.21|0.43||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.43|-0.21|0.497
70951035|NCT02209181|141403147|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.16||0.239|TWO_SIDED|95.0|-0.51|0.13||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.13|-0.51|0.239
70951036|NCT02209181|141403147|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.16||0.376|TWO_SIDED|95.0|-0.46|0.18||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.18|-0.46|0.376
70951037|NCT02209181|141403148|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.78|STANDARD_ERROR_OF_MEAN|0.32|<|0.001|TWO_SIDED|95.0|1.14|2.42||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.42|1.14|<0.001
70951038|NCT02209181|141403148|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.32||0.35|TWO_SIDED|95.0|-0.33|0.94||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.94|-0.33|0.350
70951039|NCT02209181|141403148|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.33||0.183|TWO_SIDED|95.0|-0.21|1.08||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.08|-0.21|0.183
70951040|NCT02209181|141403148|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.48|STANDARD_ERROR_OF_MEAN|0.32|<|0.001|TWO_SIDED|95.0|-2.11|-0.84||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.84|-2.11|<0.001
70951041|NCT02209181|141403148|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|95.0|-1.98|-0.7||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.70|-1.98|<0.001
70951042|NCT02209181|141403149|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.78|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|2.94|4.61||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.61|2.94|<0.001
70951043|NCT02209181|141403149|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.88|STANDARD_ERROR_OF_MEAN|0.42||0.037|TWO_SIDED|95.0|0.05|1.71||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.71|0.05|0.037
70868398|NCT02100514|141222861|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-8.2|STANDARD_ERROR_OF_MEAN|3.04||||95.0|-14.1|-2.2||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-2.2|-14.1|
70868399|NCT02100514|141222862|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|4.1|STANDARD_ERROR_OF_MEAN|0.85||||95.0|2.5|5.8||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||5.8|2.5|
70868400|NCT02100514|141222862|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|3.8|STANDARD_ERROR_OF_MEAN|0.86||||95.0|2.2|5.5||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||5.5|2.2|
70868401|NCT02100514|141222862|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|4.3|STANDARD_ERROR_OF_MEAN|0.97||||95.0|2.4|6.2||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||6.2|2.4|
70868402|NCT02100514|141222863|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|1.1|STANDARD_ERROR_OF_MEAN|0.9||||95.0|-0.7|2.8||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||2.8|-0.7|
70951044|NCT02209181|141403149|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.47|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|0.63|2.3||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.30|0.63|<0.001
70951045|NCT02209181|141403149|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-3.73|-2.07||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-2.07|-3.73|<0.001
71142638|NCT01787461|141778945|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1||||0.027|TWO_SIDED|95.0|0.12|2.09|||ANOVA|||Change at Week 12, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||2.09|0.12|0.027
70868403|NCT02100514|141222863|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|0.9|STANDARD_ERROR_OF_MEAN|1.04||||95.0|-1.1|3.0||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||3.0|-1.1|
70868404|NCT02100514|141222863|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|0.8|STANDARD_ERROR_OF_MEAN|0.95||||95.0|-1.0|2.7||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||2.7|-1.0|
70868405|NCT02100514|141222864|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-10.1|STANDARD_ERROR_OF_MEAN|2.55||||95.0|-15.1|-5.1||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-5.1|-15.1|
70868406|NCT02100514|141222864|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-9.0|STANDARD_ERROR_OF_MEAN|4.5||||95.0|-17.9|-0.2||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.2|-17.9|
70951046|NCT02209181|141403149|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.31|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.15|-1.47||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.47|-3.15|<0.001
70868407|NCT02100514|141222864|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-8.2|STANDARD_ERROR_OF_MEAN|3.04||||95.0|-14.1|-2.2||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-2.2|-14.1|
70868408|NCT02100514|141222865|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-66.8|STANDARD_ERROR_OF_MEAN|3.18||||95.0|-73.0|-60.5||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-60.5|-73.0|
70868409|NCT02100514|141222866|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-66.1|STANDARD_ERROR_OF_MEAN|5.4||||95.0|-76.7|-55.4||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-55.4|-76.7|
71142639|NCT01787461|141778945|SUPERIORITY_OR_OTHER||LS Mean Difference|0.99||||0.049|TWO_SIDED|95.0|0.01|1.96|||ANOVA|||Change at Week 18, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||1.96|0.01|0.049
71142640|NCT01787461|141778945|SUPERIORITY_OR_OTHER||LS Mean Difference|1.17||||0.019|TWO_SIDED|95.0|0.2|2.14|||ANOVA|||Change at Week 24, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||2.14|0.20|0.019
71142641|NCT01787461|141778945|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.449|TWO_SIDED|95.0|-0.36|0.8|||ANOVA|||Change at Week 6, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.80|-0.36|0.449
71142642|NCT01787461|141778945|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.105|TWO_SIDED|95.0|-0.07|0.8|||ANOVA|||Change at Week 12, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.80|-0.07|0.105
71142643|NCT01787461|141778945|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27||||0.205|TWO_SIDED|95.0|-0.14|0.68|||ANOVA|||Change at Week 18, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.68|-0.14|0.205
71142644|NCT01787461|141778945|SUPERIORITY_OR_OTHER||LS Mean Difference|0.35||||0.1|TWO_SIDED|95.0|-0.06|0.77|||ANOVA|||Change at Week 24, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.77|-0.06|0.100
71142645|NCT01787461|141778945|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.244|TWO_SIDED|95.0|-0.17|0.66|||ANOVA|||Change at Week 6, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.66|-0.17|0.244
71142646|NCT01787461|141778945|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12||||0.594|TWO_SIDED|95.0|-0.32|0.56|||ANOVA|||Change at Week 12, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.56|-0.32|0.594
71142647|NCT01787461|141778945|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.317|TWO_SIDED|95.0|-0.2|0.63|||ANOVA|||Change at Week 18, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.63|-0.20|0.317
71142648|NCT01787461|141778945|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24||||0.264|TWO_SIDED|95.0|-0.17|0.64|||ANOVA|||Change at Week 24, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.64|-0.17|0.264
71142649|NCT01787461|141778946|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.16||||0.266|TWO_SIDED|95.0|-69.63|19.31|||ANOVA|||Change at Week 6, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||19.31|-69.63|0.266
71142650|NCT01787461|141778946|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.79||||0.21|TWO_SIDED|95.0|-73.99|16.41|||ANOVA|||Change at Week 12, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||16.41|-73.99|0.210
71142651|NCT01787461|141778946|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.78||||0.753|TWO_SIDED|95.0|-56.55|40.99|||ANOVA|||Change at Week 18, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||40.99|-56.55|0.753
71142652|NCT01787461|141778946|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.9||||0.632|TWO_SIDED|95.0|-76.32|46.51|||ANOVA|||Change at Week 24, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||46.51|-76.32|0.632
71142653|NCT01787461|141778946|SUPERIORITY_OR_OTHER||LS Mean Difference|4.54||||0.715|TWO_SIDED|95.0|-19.94|29.01|||ANOVA|||Change at Week 6, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||29.01|-19.94|0.715
71142654|NCT01787461|141778946|SUPERIORITY_OR_OTHER||LS Mean Difference|6.35||||0.648|TWO_SIDED|95.0|-21.04|33.75|||ANOVA|||Change at Week 12, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||33.75|-21.04|0.648
70872237|NCT00407797|141229711|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0944|TWO_SIDED||||||t-test, 2 sided|||LOCF: Sleep Adequacy. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0944
70872238|NCT00407797|141229711|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8928|TWO_SIDED||||||t-test, 2 sided|||Week 21: Somnolence. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.8928
71142655|NCT01787461|141778946|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.49||||0.315|TWO_SIDED|95.0|-48.81|15.83|||ANOVA|||Change at Week 18, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||15.83|-48.81|0.315
71142656|NCT01787461|141778946|SUPERIORITY_OR_OTHER||LS Mean Difference|14.42||||0.402|TWO_SIDED|95.0|-19.5|48.34|||ANOVA|||Change at Week 24, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||48.34|-19.50|0.402
71142657|NCT01787461|141778946|SUPERIORITY_OR_OTHER||LS Mean Difference|12.43||||0.381|TWO_SIDED|95.0|-15.49|40.35|||ANOVA|||Change at Week 6, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||40.35|-15.49|0.381
70951047|NCT02209181|141403150|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.34|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|3.43|5.25||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||5.25|3.43|<0.001
70951048|NCT02209181|141403150|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.85|STANDARD_ERROR_OF_MEAN|0.46||0.067|TWO_SIDED|95.0|-0.06|1.75||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.75|-0.06|0.067
71142658|NCT01787461|141778946|SUPERIORITY_OR_OTHER||LS Mean Difference|1.49||||0.916|TWO_SIDED|95.0|-26.44|29.43|||ANOVA|||Change at Week 12, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||29.43|-26.44|0.916
71142659|NCT01787461|141778946|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.88||||0.566|TWO_SIDED|95.0|-43.81|24.05|||ANOVA|||Change at Week 18, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||24.05|-43.81|0.566
71142660|NCT01787461|141778946|SUPERIORITY_OR_OTHER||LS Mean Difference|8.58||||0.667|TWO_SIDED|95.0|-30.78|47.94|||ANOVA|||Change at Week 24, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||47.94|-30.78|0.667
70868410|NCT02100514|141222867|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-66.5|STANDARD_ERROR_OF_MEAN|2.77||||95.0|-72.0|-61.1||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-61.1|-72.0|
71142661|NCT01787461|141778947|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.458|TWO_SIDED|95.0|-2.21|1.0|||ANOVA|||Change at Week 6, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||1.00|-2.21|0.458
71142662|NCT01787461|141778947|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.53||||0.497|TWO_SIDED|95.0|-2.07|1.01|||ANOVA|||Change at Week 12, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||1.01|-2.07|0.497
71142663|NCT01787461|141778947|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.36||||0.113|TWO_SIDED|95.0|-3.05|0.33|||ANOVA|||Change at Week 18, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.33|-3.05|0.113
71142664|NCT01787461|141778947|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34||||0.708|TWO_SIDED|95.0|-2.11|1.44|||ANOVA|||Change at Week 24, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||1.44|-2.11|0.708
71142665|NCT01787461|141778947|SUPERIORITY_OR_OTHER||LS Mean Difference|1.24||||0.495|TWO_SIDED|95.0|-2.34|4.82|||ANOVA|||Change at Week 6, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||4.82|-2.34|0.495
71142666|NCT01787461|141778947|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.85||||0.243|TWO_SIDED|95.0|-4.96|1.27|||ANOVA|||Change at Week 12, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||1.27|-4.96|0.243
71142667|NCT01787461|141778947|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.36||||0.453|TWO_SIDED|95.0|-4.96|2.23|||ANOVA|||Change at Week 18, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||2.23|-4.96|0.453
71142668|NCT01787461|141778947|SUPERIORITY_OR_OTHER||LS Mean Difference|0.55||||0.745|TWO_SIDED|95.0|-2.79|3.89|||ANOVA|||Change at Week 24, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||3.89|-2.79|0.745
71142669|NCT01787461|141778947|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.987|TWO_SIDED|95.0|-2.44|2.48|||ANOVA|||Change at Week 6, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||2.48|-2.44|0.987
70951049|NCT02209181|141403150|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.26|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|1.34|3.17||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.17|1.34|<0.001
71142670|NCT01787461|141778947|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.42||||0.218|TWO_SIDED|95.0|-3.69|0.85|||ANOVA|||Change at Week 12, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.85|-3.69|0.218
71142671|NCT01787461|141778947|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.67||||0.63|TWO_SIDED|95.0|-3.41|2.08|||ANOVA|||Change at Week 18, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||2.08|-3.41|0.630
70951050|NCT02209181|141403150|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.49|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|-4.4|-2.59||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-2.59|-4.40|<0.001
70951051|NCT02209181|141403150|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.08|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|-3.0|-1.17||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.17|-3.00|<0.001
70951052|NCT02209181|141403151|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.87|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|3.9|5.84||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||5.84|3.90|<0.001
70951053|NCT02209181|141403151|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.13|STANDARD_ERROR_OF_MEAN|0.49||0.023|TWO_SIDED|95.0|0.16|2.09||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.09|0.16|0.023
70951054|NCT02209181|141403151|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.96|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|1.98|3.93||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.93|1.98|<0.001
70951055|NCT02209181|141403151|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.75|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|-4.71|-2.78||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-2.78|-4.71|<0.001
70951056|NCT02209181|141403151|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.91|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-2.89|-0.94||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.94|-2.89|<0.001
70951057|NCT02209181|141403152|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.71|STANDARD_ERROR_OF_MEAN|0.54|<|0.001|TWO_SIDED|95.0|3.64|5.78||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||5.78|3.64|<0.001
70951058|NCT02209181|141403152|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.36|STANDARD_ERROR_OF_MEAN|0.54||0.012|TWO_SIDED|95.0|0.3|2.42||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.42|0.30|0.012
70951059|NCT02209181|141403152|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.73|STANDARD_ERROR_OF_MEAN|0.54|<|0.001|TWO_SIDED|95.0|2.66|4.81||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.81|2.66|<0.001
70951060|NCT02209181|141403152|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.35|STANDARD_ERROR_OF_MEAN|0.54|<|0.001|TWO_SIDED|95.0|-4.41|-2.29||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-2.29|-4.41|<0.001
70951061|NCT02209181|141403152|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.54||0.074|TWO_SIDED|95.0|-2.05|0.09||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.09|-2.05|0.074
70951062|NCT02209181|141403153|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|2.63|4.97||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.97|2.63|<0.001
70951063|NCT02209181|141403153|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.32|STANDARD_ERROR_OF_MEAN|0.59||0.026|TWO_SIDED|95.0|0.16|2.48||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.48|0.16|0.026
70951064|NCT02209181|141403153|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.82|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|2.64|4.99||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.99|2.64|<0.001
70951065|NCT02209181|141403153|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.48|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|-3.64|-1.32||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.32|-3.64|<0.001
71142672|NCT01787461|141778947|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81||||0.576|TWO_SIDED|95.0|-2.06|3.68|||ANOVA|||Change at Week 24, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||3.68|-2.06|0.576
71142673|NCT00383552|141778968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
71142674|NCT00383552|141778969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
71142675|NCT00383552|141778971|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
71142676|NCT00383552|141778972|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
71142677|NCT00383552|141778973|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073|||||||Longitudinal Model|||||||0.073
70951066|NCT02209181|141403153|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.6||0.978|TWO_SIDED|95.0|-1.16|1.19||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.19|-1.16|0.978
70868411|NCT02100514|141222868|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-69.1|STANDARD_ERROR_OF_MEAN|3.08||||95.0|-75.2|-63.1||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-63.1|-75.2|
70868412|NCT02100514|141222869|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-71.3|STANDARD_ERROR_OF_MEAN|3.14||||95.0|-77.5|-65.1||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-65.1|-77.5|
70868413|NCT02100514|141222870|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-47.7|STANDARD_ERROR_OF_MEAN|2.12||||95.0|-51.9|-43.6||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-43.6|-51.9|
70868414|NCT02100514|141222871|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-10.4|STANDARD_ERROR_OF_MEAN|1.06||||95.0|-12.5|-8.3||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-8.3|-12.5|
70868415|NCT02100514|141222872|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|2.6|STANDARD_ERROR_OF_MEAN|0.52||||95.0|1.6|3.6||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||3.6|1.6|
70868416|NCT02100514|141222873|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-1.6|STANDARD_ERROR_OF_MEAN|0.08||||95.0|-1.8|-1.5||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-1.5|-1.8|
70951067|NCT02209181|141403154|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|2.18|4.62||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.62|2.18|<0.001
71142678|NCT00383552|141778974|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||||||BMI 25 to \<30|ANCOVA|||||||0.015
70951068|NCT02209181|141403154|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.07|STANDARD_ERROR_OF_MEAN|0.61||0.081|TWO_SIDED|95.0|-0.13|2.28||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.28|-0.13|0.081
71142679|NCT00383552|141778974|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||BMI less than 25 and for BMI 30 or more|ANCOVA|||||||<0.001
71142680|NCT03096834|141778976|SUPERIORITY||Odds Ratio (OR)|2.73||||0.002|TWO_SIDED|95.0|1.43|5.19|||Cochran-Mantel-Haenszel|Adjusted for stratification factor (4-7 vs. 8-14) migraine days at Baseline after missing data are imputed as non-response (NRI).||||5.19|1.43|0.002
71142681|NCT03096834|141778977|SUPERIORITY||Mean Difference (Final Values)|-1.59|STANDARD_ERROR_OF_MEAN|0.55||0.004|TWO_SIDED|95.0|-2.67|-0.51|||Mixed Models Analysis|||Month 3||-0.51|-2.67|0.004
71142682|NCT03096834|141778978|SUPERIORITY||Mean Difference (Final Values)|-3.46|STANDARD_ERROR_OF_MEAN|1.13||0.003|TWO_SIDED|95.0|-5.7|-1.23|||Mixed Models Analysis|||Physical impairment domain||-1.23|-5.70|0.003
71142683|NCT03096834|141778978|SUPERIORITY||Mean Difference (Final Values)|-3.91|STANDARD_ERROR_OF_MEAN|1.12|<|0.001|TWO_SIDED|95.0|-6.12|-1.7|||Mixed Models Analysis|||Everyday activities domain||-1.70|-6.12|<0.001
71142684|NCT03096834|141778979|SUPERIORITY||Mean Difference (Final Values)|-1.71|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-2.43|-0.99|||Mixed Models Analysis|||||-0.99|-2.43|<0.001
70868417|NCT02100514|141222873|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-1.4|STANDARD_ERROR_OF_MEAN|0.1||||95.0|-1.6|-1.3||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-1.3|-1.6|
70868418|NCT02100514|141222873|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-1.4|STANDARD_ERROR_OF_MEAN|0.12||||95.0|-1.6|-1.2||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-1.2|-1.6|
70868419|NCT02100514|141222874|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-0.4|STANDARD_ERROR_OF_MEAN|0.02||||95.0|-0.4|-0.3||||||Week 12: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.3|-0.4|
70868420|NCT02100514|141222874|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-0.3|STANDARD_ERROR_OF_MEAN|0.02||||95.0|-0.3|-0.3||||||Week 24: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.3|-0.3|
70872239|NCT00407797|141229711|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7669|TWO_SIDED||||||t-test, 2 sided|||LOCF: Somnolence. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.7669
70868421|NCT02100514|141222874|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-0.3|STANDARD_ERROR_OF_MEAN|0.04||||95.0|-0.4|-0.2||||||Week 52: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.2|-0.4|
70868422|NCT02100514|141222875|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|53.9||||||95.0|32.08|90.59||||||Week 12: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||90.59|32.08|
70868423|NCT02100514|141222875|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.0||||||95.0|11.15|26.07||||||Week 24: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||26.07|11.15|
70868424|NCT02100514|141222875|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.1||||||95.0|6.18|13.48||||||Week 52: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||13.48|6.18|
70868425|NCT02100514|141222876|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|156.4||||||95.0|48.84|501.11||||||Week 12: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||501.11|48.84|
70868426|NCT02100514|141222876|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|110.8||||||95.0|39.77|308.46||||||Week 24: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||308.46|39.77|
71142685|NCT03096834|141778980|SUPERIORITY||Odds Ratio (OR)|3.16||||0.025|TWO_SIDED|95.0|1.11|9.01|||Cochran-Mantel-Haenszel|Adjusted for stratification factor (4-7 vs. 8-14) migraine days at Baseline after missing data are imputed as non-response||||9.01|1.11|0.025
71142686|NCT01405768|141779002|SUPERIORITY_OR_OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||.13
70868427|NCT02100514|141222876|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|43.3||||||95.0|19.52|96.13||||||Week 52: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||96.13|19.52|
70868428|NCT00724932|141222883|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Final Values)|3.4|||<|0.0001|TWO_SIDED|95.0|2.8|4.1||Testing was performed using a two-sided test at the 0.05 significance level. There was only one primary comparison, therefore no adjustment for multiplicity was required.|ANOVA||Sugammadex is the numerator and neostigmine the denominator. The estimated value for the geometric mean ratio presents how many times the geometric mean time to recovery of the T4/T1 ratio to 0.9 was faster with sugammadex compared to neostigmine.|To evaluate the efficacy of sugammadex compared to neostigmine, the ratio of the geometric means of time to recovery of the T4/T1 ratio to 0.9 was calculated using a two-way analysis of variance (ANOVA) model adjusted for treatment group and trial site.||4.1|2.8|<0.0001
70868429|NCT00724932|141222884|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Final Values)|2.5|||<|0.0001|TWO_SIDED|95.0|2.1|2.8||The p-value is not adjusted for multiplicity.|ANOVA||Sugammadex is the numerator and neostigmine the denominator. The estimated value for the geometric mean ratio presents how many times the geometric mean time to recovery of the T4/T1 ratio to 0.7 was faster with sugammadex compared to neostigmine.|To evaluate the efficacy of sugammadex compared to neostigmine, the ratio of the geometric means of time to recovery of the T4/T1 ratio to 0.7 was calculated using a two-way ANOVA model adjusted for treatment group and trial site.||2.8|2.1|<0.0001
71142687|NCT01405768|141779004|SUPERIORITY_OR_OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||.13
71142688|NCT03692208|141779006|OTHER|Quantitative outcomes from chart and survey data were summarized by basic descriptive statistics.|||||<|0.01||||||P-values were calculated. Only P values of \<0.05 were considered statistically significant.|Chi-squared|Chi-squared tests, Fisher's Exact tests, two-sample t-tests, and paired two-sample t-tests were utilized to assess the outcomes between study arms.||||||<0.01
71142689|NCT01690052|141779010|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|The p-value is calculated from the ANOVA||||||0.05
71142690|NCT00599872|141779018|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.418|||<|0.05|TWO_SIDED|95.0|-1.15|0.48|||ANCOVA|||||0.48|-1.15|<0.05
71142691|NCT00599872|141779019|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.36|||<|0.05|TWO_SIDED|95.0|-1.72|0.63|||ANCOVA|||||0.63|-1.72|<0.05
70868430|NCT00724932|141222892|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Final Values)|2.9|||<|0.0001|TWO_SIDED|95.0|2.5|3.4||The p-value is not adjusted for multiplicity.|ANOVA||Sugammadex is the numerator and neostigmine the denominator. The estimated value for the geometric mean ratio presents how many times the geometric mean time to recovery of the T4/T1 ratio to 0.8 was faster with sugammadex compared to neostigmine.|To evaluate the efficacy of sugammadex compared to neostigmine, the ratio of the geometric means of time to recovery of the T4/T1 ratio to 0.8 was calculated using a two-way ANOVA model adjusted for treatment group and trial site.||3.4|2.5|<0.0001
70868431|NCT02218320|141222922|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
70868432|NCT02096731|141222925|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.92|1.37|||||"HR adjusted for 10 year age groups, sex, calendar year of cohort entry, the decile of propensity score, ipratropium use prior to cohort entry and time since entry into base cohort.~Ratio calculated as combination therapy divided by monotherapy."|||1.37|0.92|
70868433|NCT02096731|141222926|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.69|1.1|||||"HR adjusted for 10 year age groups, sex, calendar year of cohort entry, the decile of propensity score, ipratropium use prior to cohort entry and time since entry into base cohort.~Ratio calculated as combination therapy divided by monotherapy."|||1.10|0.69|
70868434|NCT02096731|141222927|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|1.03|1.3|||||"HR adjusted for 10 year age groups, sex, calendar year of cohort entry, the decile of propensity score, ipratropium use prior to cohort entry and time since entry into base cohort.~Ratio calculated as combination therapy divided by monotherapy."|||1.30|1.03|
70868435|NCT02096731|141222928|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.81|1.36|||||"HR adjusted for 10 year age groups, sex, calendar year of cohort entry, the decile of propensity score, ipratropium use prior to cohort entry and time since entry into base cohort.~Ratio calculated as combination therapy divided by monotherapy."|||1.36|0.81|
70951069|NCT02209181|141403154|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.91|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|2.69|5.14||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||5.14|2.69|<0.001
71142692|NCT01693029|141779031|EQUIVALENCE|"Equivalence margin (-0.5, 0.5) g/dL. Results from ANCOVA with factors treatment group and covariates mean baseline Hb and mean weekly dose during the evaluation period (Week 21-28)"|Mean Difference (Final Values)|-0.0926|||||TWO_SIDED|90.0|-0.2264|0.0413|||||||95% confidence interval for the difference is (-0.2522, 0.0670).|0.0413|-0.2264|
71142693|NCT04233008|141779101|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
71142694|NCT04233008|141779102|SUPERIORITY|||||||0.14|||||||Chi-squared|||||||0.14
71142695|NCT04233008|141779103|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71142696|NCT04233008|141779104|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
71142697|NCT04233008|141779105|SUPERIORITY||||||<|0.01|||||||Chi-squared|||||||<0.01
71142698|NCT04233008|141779107|SUPERIORITY|||||||0.8|||||||Chi-squared|||||||0.8
71142699|NCT00435409|141779129|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2239||||0.9409|TWO_SIDED|95.0|0.9487|1.5789||Stratification factors included metastatic organ sites (2 or less versus \[vs\] more than \[\>\] 2 sites), hormone receptor status (HER2-/ER-/PR-) vs all others), and prior chemotherapy regimens (1 vs \>1), from interactive voice response system (IVRS).|Log Rank|||A stratified log-rank test (1-sided, α=0.025) based on randomization stratification factors||1.5789|0.9487|0.9409
71142700|NCT00435409|141779129|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1084||||0.812|TWO_SIDED|95.0|0.8817|1.3935||Stratification factors include metastatic organ sites (2 or less versus \[vs\] 2 or more sites), hormone receptor status (HER2-/ER-/PR-) vs all others), and prior chemotherapy regimens (1 vs more than 1), from IVRS.|Log Rank|||A stratified log-rank test (1-sided, α=0.025) based on randomization stratification factors||1.3935|0.8817|0.8120
71142701|NCT00435409|141779130|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.3143|TWO_SIDED|95.0|0.69|1.97||A stratified CMH test stratified by randomization stratification factors was used to compare objective response rate (ORR) between two treatment arms.|Cochran-Mantel-Haenszel|||Independent radiology assessment||1.97|0.69|0.3143
71142702|NCT00435409|141779130|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.1269|TWO_SIDED|95.0|0.83|2.13||A stratified CMH test stratified by randomization stratification factors was used to compare ORR between two treatment arms.|Cochran-Mantel-Haenszel|||Investigator's assessment||2.13|0.83|0.1269
71142703|NCT00435409|141779132|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0372||||0.6275|TWO_SIDED|95.0|0.8322|1.2927||Stratification factors (all from IVRS) included number of metastatic organ sites (\<=2 vs \>2 sites), hormone receptor status (HER2-/ER-/PR- vs all others), and prior chemotherapy regimens (1 vs \>1).|Log Rank||Hazard ratio for sunitinib + capecitabine versus capecitabine.|||1.2927|0.8322|0.6275
71142704|NCT00883779|141779175|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.46|0.7|||Log Rank|||||0.70|0.46|<0.0001
71142705|NCT00883779|141779177|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.39|0.64|||Log Rank|||PFS in adenocarcinoma subgroup||0.64|0.39|<0.0001
71142706|NCT00883779|141779177|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|||=|0.579|TWO_SIDED|95.0|0.6|1.33|||Log Rank|||PFS in non-adenocarcinoma subgroup||1.33|0.60|=0.579
71142707|NCT00883779|141779177|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39|||<|0.0001|TWO_SIDED|95.0|0.28|0.53|||Log Rank|||PFS in never smoked subgroup||0.53|0.28|<0.0001
71142708|NCT00883779|141779177|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84|||=|0.2067|TWO_SIDED|95.0|0.64|1.1|||Log Rank|||PFS in former/current smoker subgroup||1.10|0.64|=0.2067
71142709|NCT00883779|141779177|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.12|0.35|||Log Rank|||PFS in subgroup EGFR mutation||0.35|0.12|<0.0001
71142710|NCT00883779|141779177|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95|||=|0.7511|TWO_SIDED|95.0|0.67|1.34|||Log Rank|||PFS in subgroup EGFR wild-type||1.34|0.67|=0.7511
70868436|NCT02096731|141222929|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.35|||||TWO_SIDED|95.0|1.23|1.5|||||"HR adjusted for 10 year age groups, sex, calendar year of cohort entry, the decile of propensity score, ipratropium use prior to cohort entry and time since entry into base cohort.~Ratio calculated as combination therapy divided by monotherapy."|||1.50|1.23|
71142711|NCT00883779|141779177|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||=|0.3169|TWO_SIDED|95.0|0.25|1.58|||Log Rank|||PFS in subgroup KRAS mutation||1.58|0.25|=0.3169
71142712|NCT00883779|141779177|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.37|0.7|||Log Rank|||PFS in subgroup KRAS wild-type||0.70|0.37|<0.0001
71142713|NCT00883779|141779177|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.51|||=|0.0091|TWO_SIDED|95.0|0.31|0.86|||Log Rank|||PFS in subgroup EGFR IHC positive||0.86|0.31|=0.0091
71142714|NCT00883779|141779177|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||=|0.0179|TWO_SIDED|95.0|0.18|0.88|||Log Rank|||PFS in subgroup EGFR IHC negative||0.88|0.18|=0.0179
71142715|NCT00883779|141779177|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26|||=|0.0017|TWO_SIDED|95.0|0.11|0.64|||Log Rank|||PFS in subgroup EGFR FISH positive||0.64|0.11|=0.0017
71142716|NCT00883779|141779177|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67|||=|0.188|TWO_SIDED|95.0|0.37|1.22|||Log Rank|||PFS in subgroup EGFR FISH negative||1.22|0.37|=0.1880
71142717|NCT00883779|141779178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85|||=|0.1213|TWO_SIDED|95.0|0.7|1.04|||Log Rank|||OS in overall participants (FAS population)||1.04|0.70|=0.1213
71142718|NCT00883779|141779178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78|||=|0.0356|TWO_SIDED|95.0|0.62|0.98|||Log Rank|||OS in subgroup adenocarcinoma||0.98|0.62|=0.0356
71142719|NCT00883779|141779178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.37|||=|0.1157|TWO_SIDED|95.0|0.92|2.03|||Log Rank|||OS in subgroup non-adenocarcinoma||2.03|0.92|=0.1157
70868437|NCT00885846|141222944|NON_INFERIORITY_OR_EQUIVALENCE|Regression analysis performed for equal variance at baseline.||||||0.664||95.0|||||Repeated ANOVA|degrees of freedom = 2||Power analysis suggested 27 participants, 9 in each group.||||0.664
70868438|NCT01081678|141222946|OTHER|||||||0.1983|||||||F-test|The p-value is based on F-test of multi-linear contrasts at Week 6 through Week 20.||The primary analysis was based on a test for linear trend in dose response at weeks 6, 12, 16, and 20. To account for multiple comparisons over time points, the primary analysis used a size α = 0.05 F-test with 4 degrees of freedom for the contrasts at Weeks 6, 12, 16, and 20.||||0.1983
70868439|NCT01496248|141222961|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
70868440|NCT01496248|141222962|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
70868441|NCT01496248|141222963|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
70868442|NCT01496248|141222964|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
70868443|NCT01496248|141222965|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
70951070|NCT02209181|141403154|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.32|STANDARD_ERROR_OF_MEAN|0.61|<|0.001|TWO_SIDED|95.0|-3.53|-1.11||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.11|-3.53|<0.001
70868444|NCT01496248|141222966|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
70951071|NCT02209181|141403154|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.62||0.407|TWO_SIDED|95.0|-0.71|1.74||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.74|-0.71|0.407
71142720|NCT00883779|141779178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66|||=|0.0056|TWO_SIDED|95.0|0.49|0.89|||Log Rank|||OS in subgroup never smoked||0.89|0.49|=0.0056
71142721|NCT00883779|141779178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14|||=|0.3473|TWO_SIDED|95.0|0.87|1.5|||Log Rank|||OS in subgroup current/former smoker||1.50|0.87|=0.3473
70868445|NCT01496248|141222967|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
70868446|NCT01496248|141222968|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
70868447|NCT02983825|141222984|SUPERIORITY|Wilcoxon signed-rank test for nonparametric matched-pairs||||||0.02|||||||Sign test|||"Within subject repeat analysis; V/Q mismatch (measured as degree of right shift in kPa) baseline vs best CPAP"||||0.02
70868448|NCT01702805|141222986|SUPERIORITY||Risk Ratio (RR)|1.0||||0.93|TWO_SIDED|95.0|0.92|1.1|||Robust Poisson Regression|The relative risk was adjusted for birth-weight and center stratum.||Null hypothesis: A higher hemoglobin threshold for red-cell transfusions, as compared with a lower threshold, will not reduce nor increase the incidence of death or neurodevelopmental impairment in infants at 22 to 26 months of age corrected for prematurity.||1.10|0.92|0.93
70868449|NCT02499783|141223016|SUPERIORITY||Adjusted Risk Difference|30.4|||<|0.001|TWO_SIDED|95.0|19.2|41.7|||Cochran-Mantel-Haenszel|Stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Risk difference = (adalimumab 160/80 mg - placebo). Stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|||41.7|19.2|<0.001
70868450|NCT02499783|141223017|SUPERIORITY||Risk Difference Compared to 30%|34.6|||<|0.001|TWO_SIDED|95.0|26.2|42.4|||One Sample Exact Test|The one sample Exact test was performed by comparing it to the clinically meaningful remission rate of 30%.||||42.4|26.2|< 0.001
70868451|NCT02499783|141223018|SUPERIORITY||Adjusted Risk Difference|33.4|||<|0.001|TWO_SIDED|95.0|23.2|43.6||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|||43.6|23.2|< 0.001
70868452|NCT02499783|141223022|SUPERIORITY||Adjusted Risk Difference|40.4|||<|0.001|TWO_SIDED|95.0|26.7|54.2||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|||54.2|26.7|< 0.001
70868453|NCT02499783|141223023|SUPERIORITY||Adjusted Risk Difference|50.2|||<|0.001|TWO_SIDED|95.0|36.9|63.5||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|||63.5|36.9|< 0.001
70868454|NCT02499783|141223024|SUPERIORITY||Adjusted Risk Difference|27.6|||<|0.001|TWO_SIDED|95.0|18.2|37.0||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|||37.0|18.2|< 0.001
70868455|NCT02499783|141223026|SUPERIORITY||Adjusted Risk Difference|19.6||||0.002|TWO_SIDED|95.0|7.1|32.1||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|||32.1|7.1|0.002
70868456|NCT02499783|141223028|SUPERIORITY||Least Squares Mean Difference|-385.2|||<|0.001|TWO_SIDED|95.0|-598.81|-171.5||P-value for test of difference between adalimumab and placebo for mean change from Baseline using ANCOVA with Treatment, Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline, and Baseline value as covariate.|ANCOVA|||||-171.50|-598.81|< 0.001
70872240|NCT00407797|141229711|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1698|TWO_SIDED||||||t-test, 2 sided|||Week 21: 9-Item Overall Sleep Problems Index. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.1698
71142722|NCT00883779|141779178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|||=|0.1614|TWO_SIDED|95.0|0.45|1.14|||Log Rank|||OS in subgroup EGFR mutation||1.14|0.45|=0.1614
71142723|NCT00883779|141779178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78|||=|0.1691|TWO_SIDED|95.0|0.55|1.11|||Log Rank|||OS in subgroup EGFR wild-type||1.11|0.55|=0.1691
71142724|NCT00883779|141779178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||=|0.1415|TWO_SIDED|95.0|0.19|1.28|||Log Rank|||OS in subgroup KRAS mutation||1.28|0.19|=0.1415
71142725|NCT00883779|141779178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||=|0.1447|TWO_SIDED|95.0|0.59|1.08|||Log Rank|||OS in subgroup KRAS wild-type||1.08|0.59|=0.1447
71142726|NCT00883779|141779178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||=|0.031|TWO_SIDED|95.0|0.35|0.96|||Log Rank|||OS in EGFR IHC positive||0.96|0.35|=0.0310
71142727|NCT00883779|141779178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46|||=|0.0581|TWO_SIDED|95.0|0.21|1.05|||Log Rank|||OS in subgroup EGFR IHC negative||1.05|0.21|=0.0581
71142728|NCT00883779|141779178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.32|||=|0.0063|TWO_SIDED|95.0|0.14|0.75|||Log Rank|||OS of subgroup EGFR FISH positive||0.75|0.14|=0.0063
71142729|NCT00883779|141779178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||=|0.3268|TWO_SIDED|95.0|0.4|1.36|||Log Rank|||OS of subgroup EGFR FISH negative||1.36|0.40|=0.3268
71142730|NCT00883779|141779180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.81|||=|0.5289|TWO_SIDED|95.0|-6.2|11.8|||Chi-squared|||Difference in non-progression response rates||11.8|-6.2|=0.5289
71142731|NCT00883779|141779181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.14|||<|0.0001|TWO_SIDED|95.0|16.7|33.5|||Chi-squared|||Difference in objective response rates||33.5|16.7|<0.0001
71142732|NCT00883779|141779182|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.32|||<|0.0001|TWO_SIDED|95.0|0.21|0.5|||Log Rank|||||0.50|0.21|<0.0001
71142733|NCT00883779|141779183|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55|||<|0.0001|TWO_SIDED|95.0|0.45|0.69|||Log Rank|||||0.69|0.45|<0.0001
71142734|NCT00883779|141779185|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79|||=|0.0364|TWO_SIDED|95.0|0.63|0.99|||Log Rank|||||0.99|0.63|=0.0364
71142735|NCT00883779|141779187|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77|||=|0.0181|TWO_SIDED|95.0|0.61|0.96|||Log Rank|||||0.96|0.61|=0.0181
71142736|NCT00883779|141779189|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.73|||=|0.0035|TWO_SIDED|95.0|0.59|0.9|||Log Rank|||||0.90|0.59|=0.0035
71142737|NCT00883779|141779190|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.913|TWO_SIDED|95.0|0.6|1.59|||Log Rank|||||1.59|0.60|0.9130
71142738|NCT02174731|141779192|NON_INFERIORITY|Non-inferiority of roxadustat versus epoetin alfa was declared if the lower bound of the 95% confidence interval (CI) of the difference between roxadustat and epoetin alfa exceeded -0.75. Non-inferiority p-value is 1-sided.|Least Square Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.044|<|0.001|TWO_SIDED|95.0|0.01|0.18|||ANCOVA||Difference between groups (roxadustat minus Epoetin alfa) in LS mean changes.|||0.18|0.01|<0.001
71142739|NCT02174731|141779193|NON_INFERIORITY|Non-inferiority of roxadustat versus epoetin alfa was declared if the lower bound of the 95% CI of the difference between roxadustat and epoetin alfa exceeded -0.75. Non-inferiority p-value is 1-sided.|Least Square Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.056|<|0.001|TWO_SIDED|95.0|0.03|0.25|||MMRM||Difference between groups (roxadustat minus Epoetin alfa) in LS mean change.|||0.25|0.03|<0.001
71142740|NCT02174731|141779194|NON_INFERIORITY|Non-inferiority of roxadustat versus epoetin alfa was declared if the lower bound of the 95% CI of the difference between roxadustat and epoetin alfa exceeded -0.15. Non-inferiority p-value is 1-sided.|Least Square Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.013|<|0.001|TWO_SIDED|95.0|0.0|0.05|||ANCOVA||Difference between groups (roxadustat minus Epoetin alfa) in LS mean.|||0.05|0.00|<0.001
71142741|NCT02174731|141779195|NON_INFERIORITY|Non-inferiority of roxadustat versus epoetin alfa was declared if the lower bound of the 95% CI of the difference between roxadustat and epoetin alfa exceeded -0.15. Non-inferiority p-value is 1-sided.|Least Square Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.014|<|0.001|TWO_SIDED|95.0|-0.01|0.05|||ANCOVA||Difference between groups (roxadustat minus Epoetin alfa) in LS mean.|||0.05|-0.01|<0.001
71142742|NCT02174731|141779196|SUPERIORITY|Superiority was also declared as the lower bound of the 95% CI exceeded 0 and p-value was lower than 0.05.|Least Square Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|-0.39|-0.27|||ANCOVA||Difference between groups (roxadustat minus Epoetin alfa) in LS mean.|||-0.27|-0.39|<0.001
71142743|NCT02174731|141779197|NON_INFERIORITY|Non-inferiority of roxadustat versus epoetin alfa was declared if the lower bound of the 95% CI of the difference between roxadustat and epoetin alfa exceeded -0.75. Non-inferiority p-value is 1-sided.|Least Square Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.081|<|0.001|TWO_SIDED|95.0|0.04|0.36|||ANCOVA|MAR-based multiple imputation.|Difference between groups (roxadustat minus Epoetin alfa) in LS mean.|||0.36|0.04|<0.001
71142744|NCT02174731|141779198|SUPERIORITY||||||<|0.0001|||||||Wilcoxon Rank Sum Test|||||||<0.0001
71142745|NCT02174731|141779199|NON_INFERIORITY|Non-inferiority of roxadustat versus epoetin alfa was declared if the upper bound of the HR 95% CI of the difference between roxadustat and epoetin alfa was less than or equal to 1.8. Non-inferiority p-value is 1-sided. The CIs were from Wald and ties were calculated using the Efron method.|Hazard Ratio (HR)|0.83|||<|0.001|TWO_SIDED|95.0|0.64|1.07|||Regression, Cox|||||1.07|0.64|<0.001
71142746|NCT00079040|141779202|SUPERIORITY_OR_OTHER||Percentage|63.5|||||TWO_SIDED|90.0|52.4|73.6||||||||73.6|52.4|
71142747|NCT00467740|141779256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.045||0.0754||95.0|-0.008|0.167|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.167|-0.008|0.0754
71142748|NCT00467740|141779256|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.045||0.0571||95.0|-0.003|0.174|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.174|-0.003|0.0571
71142749|NCT00467740|141779256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.076|STANDARD_ERROR_OF_MEAN|0.045||0.0906||95.0|-0.012|0.164|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.164|-0.012|0.0906
71142750|NCT00467740|141779256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.044||0.0011||95.0|0.059|0.234|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.234|0.059|0.0011
71142751|NCT00467740|141779257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.238|STANDARD_ERROR_OF_MEAN|7.843||0.0393||95.0|0.801|31.675|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||31.675|0.801|0.0393
71142752|NCT00467740|141779257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.878|STANDARD_ERROR_OF_MEAN|7.875||0.0005||95.0|12.379|43.378|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||43.378|12.379|0.0005
71142753|NCT00467740|141779257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.072|STANDARD_ERROR_OF_MEAN|7.906|<|0.0001||95.0|20.512|51.633|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||51.633|20.512|<0.0001
71142754|NCT00467740|141779257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.943|STANDARD_ERROR_OF_MEAN|7.848|<|0.0001||95.0|27.498|58.389|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||58.389|27.498|<0.0001
71142755|NCT00467740|141779258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.067|STANDARD_ERROR_OF_MEAN|0.044||0.1264||95.0|-0.019|0.154|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.154|-0.019|0.1264
71142756|NCT00467740|141779258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.044||0.0232||95.0|0.014|0.188|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.188|0.014|0.0232
71142757|NCT00467740|141779258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.044||0.0106||95.0|0.027|0.2|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.200|0.027|0.0106
71142758|NCT00467740|141779258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.044||0.0001||95.0|0.087|0.26|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.260|0.087|0.0001
71142759|NCT00467740|141779259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.048||0.0329||95.0|0.008|0.198|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.198|0.008|0.0329
71142760|NCT00467740|141779259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.048||0.0666||95.0|-0.006|0.184|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.184|-0.006|0.0666
71142761|NCT00467740|141779259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.043|STANDARD_ERROR_OF_MEAN|0.048||0.3738||95.0|-0.052|0.137|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.137|-0.052|0.3738
71142762|NCT00467740|141779259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.048||0.0037||95.0|0.046|0.234|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.234|0.046|0.0037
71142763|NCT00467740|141779260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.051|STANDARD_ERROR_OF_MEAN|0.046||0.2646||95.0|-0.039|0.142|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.142|-0.039|0.2646
71142764|NCT00467740|141779260|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.043|STANDARD_ERROR_OF_MEAN|0.046||0.3527||95.0|-0.048|0.135|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.135|-0.048|0.3527
71142765|NCT00467740|141779260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.046||0.1369||95.0|-0.022|0.16|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.160|-0.022|0.1369
71142766|NCT00467740|141779260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.046||0.0051||95.0|0.039|0.221|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.221|0.039|0.0051
71142767|NCT00467740|141779261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.053||0.017||95.0|0.023|0.232|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.232|0.023|0.0170
71142768|NCT00467740|141779261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.053||0.0646||95.0|-0.006|0.204|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.204|-0.006|0.0646
71142769|NCT00467740|141779261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028|STANDARD_ERROR_OF_MEAN|0.053||0.602||95.0|-0.077|0.132|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.132|-0.077|0.6020
71142770|NCT00467740|141779261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.053||0.0147||95.0|0.026|0.233|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.233|0.026|0.0147
70868457|NCT02499783|141223029|SUPERIORITY||Adjusted Risk Difference|9.8||||0.001|TWO_SIDED|95.0|3.9|15.8||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|||15.8|3.9|0.001
70868458|NCT02499783|141223031|SUPERIORITY||Adjusted Risk Difference|18.4|||<|0.001|TWO_SIDED|95.0|8.2|28.6||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Clinical Remission at Week 2||28.6|8.2|< 0.001
70868459|NCT02499783|141223031|SUPERIORITY||Adjusted Risk Difference|30.4|||<|0.001|TWO_SIDED|95.0|19.2|41.7||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Clinical Remission at Week 4||41.7|19.2|< 0.001
70868460|NCT02499783|141223033|SUPERIORITY||Adjusted Risk Difference|21.4|||<|0.001|TWO_SIDED|95.0|12.6|30.2||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Clinical Remission (CDAI \< 150) Plus A Reduction in HS-CRP of at Least 50% From Baseline at Week 2||30.2|12.6|< 0.001
70868461|NCT02499783|141223033|SUPERIORITY||Adjusted Risk Difference|33.4|||<|0.001|TWO_SIDED|95.0|23.2|43.6||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Clinical Remission (CDAI \< 150) Plus A Reduction in HS-CRP of at Least 50% From Baseline at Week 4||43.6|23.2|< 0.001
70868462|NCT02499783|141223035|SUPERIORITY||Adjusted Risk Difference|21.7||||0.001|TWO_SIDED|95.0|8.7|34.6||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 2||34.6|8.7|0.001
70868463|NCT02499783|141223035|SUPERIORITY||Adjusted Risk Difference|40.4|||<|0.001|TWO_SIDED|95.0|26.7|54.2||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 4||54.2|26.7|< 0.001
70868464|NCT02499783|141223037|SUPERIORITY||Adjusted Risk Difference|31.4|||<|0.001|TWO_SIDED|95.0|19.6|43.2||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Decrease in CDAI ≥ 70 Points From Baseline Plus a Reduction in Hs-CRP of at Least 30% From Baseline at Week 2||43.2|19.6|< 0.001
70868465|NCT02499783|141223037|SUPERIORITY||Adjusted Risk Difference|50.2|||<|0.001|TWO_SIDED|95.0|36.9|63.5||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Decrease in CDAI ≥ 70 Points From Baseline Plus a Reduction in Hs-CRP of at Least 30% From Baseline at Week 4||63.5|36.9|< 0.001
70868466|NCT02499783|141223039|SUPERIORITY||Least Squares Mean Difference|-43.34|||<|0.001|TWO_SIDED|95.0|-59.39|-27.3||P-value for test of difference between adalimumab and placebo for mean change from Baseline using ANCOVA with Treatment, Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline, and Baseline value as covariate.|ANCOVA|||Change From Baseline in CDAI at Week 2||-27.30|-59.39|< 0.001
70868467|NCT02499783|141223039|SUPERIORITY||Least Squares Mean Difference|-66.63|||<|0.001|TWO_SIDED|95.0|-84.2|-49.06||P-value for test of difference between adalimumab and placebo for mean change from Baseline using ANCOVA with Treatment, Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline, and Baseline value as covariate.|ANCOVA|||Change From Baseline in CDAI at Week 4||-49.06|-84.20|< 0.001
70868468|NCT02499783|141223041|SUPERIORITY||Least Squares Mean Difference|-13.921|||<|0.001|TWO_SIDED|95.0|-19.183|-8.659||P-value for test of difference between adalimumab and placebo for mean change from Baseline using ANCOVA with Treatment, Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline, and Baseline value as covariate.|ANCOVA|||Change From Baseline in hs-CRP Level at Week 2||-8.659|-19.183|< 0.001
70868469|NCT02499783|141223041|SUPERIORITY||Least Squares Mean Difference|-16.844|||<|0.001|TWO_SIDED|95.0|-21.206|-12.483||P-value for test of difference between adalimumab and placebo for mean change from Baseline using ANCOVA with Treatment, Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline, and Baseline value as covariate.|ANCOVA|||Change From Baseline in hs-CRP Level at Week 4||-12.483|-21.206|< 0.001
71142771|NCT00467740|141779262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|STANDARD_ERROR_OF_MEAN|0.053||0.4902||95.0|-0.068|0.142|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.142|-0.068|0.4902
70868470|NCT04457336|141223052|OTHER|Assessment of dose response for change from baseline in log 17-OHP after 12 weeks on double-blind, placebo-controlled treatment (Week 18). Results were obtained by using a repeated measures random coefficient mixed-effects model and are reported as the -2loglikelihood results for both the full (including interaction terms) and reduced (excluding interaction terms) models.||||||0.8051||||||Dose response p-value|Mixed Models Analysis|The result for the -2loglikelihood full model was -580.2550766 log(ng/dL) and -583.2846546 log(ng/dL) for the reduced model.||||||0.8051
70868471|NCT04203498|141223120|SUPERIORITY||Difference in least squares means|-0.73|STANDARD_ERROR_OF_MEAN|0.914|=|0.4263|TWO_SIDED|95.0|-2.54|1.08|||Linear mixed model repeated measures|||Week 9 to 12 (primary outcome statistics)||1.08|-2.54|=0.4263
70868472|NCT02935842|141223160|OTHER|||||||||||||||||First Reliable Change (RC), Reliable Change Index (RCI) were calculated on every individual score. Further, ANOVAs and t-tests were administered in order to verify differences between groups or interventions. Significance levels were set at p \< .05.|Reliable Change / Reliable Change Index according to Jacobson \& Truax (1991). There, on the basis of every individual score, the change in performance (i.e. BL-4Weeks/ BL-6Months) has been calculated and is reported with level of significance as well as effect size.|||
70868473|NCT02935842|141223160|OTHER|||||||0.05|||||||ANOVA|||||||.05
70868474|NCT02935842|141223164|OTHER|||||||0.05|||||||ANOVA|||||||.05
70868475|NCT02935842|141223166|OTHER|||||||0.05|||||||ANOVA|||||||.05
70868476|NCT04545385|141223168|OTHER||Odds Ratio (OR)|1.49||||0.7817|TWO_SIDED|95.0|0.545|4.071|||Regression, Logistic|||Analysis was performed using logistic regression with fixed effects for treatment, baseline FEV1, weight, age group, and gender.||4.071|0.545|0.7817
70868477|NCT00191139|141223190|SUPERIORITY_OR_OTHER||survival rate|40.6||||||95.0|23.8|56.8|||normal approximation|Count the number of surviving participants at each time interval to get survival rates.||||56.8|23.8|
70868478|NCT00191139|141223190|SUPERIORITY_OR_OTHER||survival rate|55.7||||||95.0|36.8|70.9|||normal approximation|Count the number of surviving participants at each time interval to get survival rates.||||70.9|36.8|
70868479|NCT00191139|141223191|SUPERIORITY_OR_OTHER||Response Rate|75.0||||||95.0|56.6|88.5|||normal approximation|||||88.5|56.6|
70868480|NCT00191139|141223191|SUPERIORITY_OR_OTHER||Response rate|84.4||||||95.0|67.2|94.7|||Normal approximation|||||94.7|67.2|
70868481|NCT00191139|141223192|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Log Rank|||||||0.08
70868482|NCT00191139|141223193|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||Log Rank|||||||0.38
70868483|NCT00758836|141223195|SUPERIORITY_OR_OTHER||Proportion difference|24.5|||<|0.001|TWO_SIDED|90.0|16.7|32.2|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomial distribution stratified by baseline severity.||||32.2|16.7|<0.001
70868484|NCT00758836|141223195|SUPERIORITY_OR_OTHER||Proportion difference|27.7|||<|0.001|TWO_SIDED|90.0|19.6|35.8|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||35.8|19.6|<0.001
70868485|NCT00758836|141223195|SUPERIORITY_OR_OTHER||Proportion difference|20.4|||<|0.001|TWO_SIDED|90.0|12.6|28.2|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||28.2|12.6|<0.001
70868486|NCT00758836|141223195|SUPERIORITY_OR_OTHER||Proportion differenece|4.2||||0.449|TWO_SIDED|90.0|-5.0|13.3|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||13.3|-5.0|0.449
70868487|NCT00758836|141223195|SUPERIORITY_OR_OTHER||Proportion difference|7.7||||0.182|TWO_SIDED|90.0|-1.8|17.1|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||17.1|-1.8|0.182
70868488|NCT00758836|141223196|SUPERIORITY_OR_OTHER||Proportion difference|40.8|||<|0.001|TWO_SIDED|90.0|31.9|49.0|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||49.0|31.9|<0.001
70868489|NCT00758836|141223196|SUPERIORITY_OR_OTHER||Proportion difference|39.9|||<|0.001|TWO_SIDED|90.0|30.5|48.5|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||48.5|30.5|<0.001
70868490|NCT00758836|141223196|SUPERIORITY_OR_OTHER||Proportion difference|6.1||||0.265|TWO_SIDED|90.0|-2.9|14.9|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||14.9|-2.9|0.265
70868491|NCT00758836|141223196|SUPERIORITY_OR_OTHER||Proportion difference|5.2||||0.362|TWO_SIDED|90.0|-4.2|14.5|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||14.5|-4.2|0.362
70868492|NCT00758836|141223196|SUPERIORITY_OR_OTHER||Proportion difference|34.7|||<|0.001|TWO_SIDED|90.0|25.3|43.4|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||43.4|25.3|<0.001
70868493|NCT03128411|141223213|SUPERIORITY||||||<|0.0001|||||||z-test, 1-sided|||With a sample size of 60 participants, study was powered at \>82% to test null hypothesis: true MMR rate at 12 months (48 weeks) is 25% versus alternative hypothesis: true MMR rate is 40% with one-sided alpha of 5%.||||<0.0001
70868494|NCT01633853|141223266|SUPERIORITY_OR_OTHER|||||||0.117|TWO_SIDED||||||t-test, 2 sided|||The blood levels of calcium at the 24th month of following up were compared to the levels of the baseline both in group Vitamin D2.||||0.117
70868495|NCT01633853|141223266|SUPERIORITY_OR_OTHER|||||||0.309|TWO_SIDED||||||t-test, 2 sided|||The blood levels of calcium at the 24th month of following up were compared to the levels of the baseline in group 1,25(OH)2 Vitamin D3.||||0.309
70868496|NCT01633853|141223266|SUPERIORITY_OR_OTHER|||||||0.554|TWO_SIDED|||||t=-0.593|t-test, 2 sided|||The levels of blood calcium at the 24th month of following up were compared between two groups.||||0.554
70868497|NCT01633853|141223267|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||The levels of blood 25(OH)Vitamin D were compared between the 24th month and the baseline in group Vitamin D2.||||<0.001
70868498|NCT01633853|141223267|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||The levels of blood 25(OH)Vitamin D were compared between the 24th month and the baseline in group 1,25(OH)2 Vitamin D3.||||<0.001
70868499|NCT01633853|141223267|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P\<0.001, t=-14.982.|t-test, 2 sided|||The levels of blood 25(OH) Vitamin D at the 24th month of following up were compared between two groups.||||<0.001
70868500|NCT01633853|141223268|SUPERIORITY_OR_OTHER|||||||0.753|TWO_SIDED|||||Chi-square value=0.099|Chi-squared|||||||0.753
70868501|NCT01633853|141223269|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||The levels of blood phosphorus were compared between the 24th month of following up and the baseline in group Vitamin D2.||||<0.001
70868502|NCT01633853|141223269|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||The levels of blood phosphorus were compared between the 24th month of following up and the baseline in group 1,25(OH)2 Vitamin D3, respectively.||||<0.001
70868503|NCT01633853|141223269|SUPERIORITY_OR_OTHER|||||||0.694|TWO_SIDED|||||t=0.394|t-test, 2 sided|||The levels of blood phosphorus at the 24th month of following up were compared between two groups.||||0.694
70868504|NCT01633853|141223270|SUPERIORITY_OR_OTHER|||||||0.179|TWO_SIDED||||||t-test, 2 sided|||The levels of blood iPTH were compared between the 24th month and the baseline in group Vitamin D2.||||0.179
70868505|NCT01633853|141223270|SUPERIORITY_OR_OTHER|||||||0.106|TWO_SIDED||||||t-test, 2 sided|||The levels of blood iPTH were compared between the 24th month and the baseline group 1,25(OH)2 Vitamin D3, respectively.||||0.106
70868506|NCT01633853|141223270|SUPERIORITY_OR_OTHER|||||||0.463|TWO_SIDED|||||t=-0.736|t-test, 2 sided|||The levels of blood iPTH at the 24th month of following up were compared between two groups.||||0.463
70868507|NCT02785432|141223271|SUPERIORITY|||||||0.55||||||Between group comparison at 8 weeks|Wilcoxon (Mann-Whitney)|||||||0.55
70868508|NCT02785432|141223272|SUPERIORITY|||||||0.66||||||Between group comparison at 8 weeks|Wilcoxon (Mann-Whitney)|||||||0.66
70868509|NCT02785432|141223273|SUPERIORITY|||||||0.51||||||Between group comparison at 8 weeks|Wilcoxon (Mann-Whitney)|||||||0.51
70868510|NCT02785432|141223274|SUPERIORITY|||||||0.96||||||Between group comparison at 8 weeks|Wilcoxon (Mann-Whitney)|||||||0.96
70868511|NCT01673867|141223309|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0015|TWO_SIDED|95.92|0.59|0.89|||Log Rank||HR = Nivolumab over docetaxel|||0.89|0.59|0.0015
70868512|NCT02195583|141223332|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|Calculated from Analysis of Variance (ANOVA) model using treatment and study period as fixed factors and participant as random effect.||Linear contrasts were fitted in order to establish whether there was a dose-response relationship. Linear contrasts were for experimental dentifrice: non-zinc treatments.||||<0.0001
70868513|NCT02195583|141223332|SUPERIORITY_OR_OTHER|||||||0.2274||95.0|||||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.||Quadratic contrasts were fitted in order to establish whether there was a dose-response relationship. Quadratic contrasts are for experimental dentifrice: non-zinc treatments.||||0.2274
70868514|NCT02195583|141223332|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.68||||0.595|TWO_SIDED|95.0|-1.84|3.2|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1426 ppm) minus Sodium fluoride (1150 ppm) such that a positive difference favors Sodium fluoride (1426 ppm).|||3.20|-1.84|0.5950
70868515|NCT02195583|141223332|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.93||||0.0002|TWO_SIDED|95.0|2.38|7.48|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1426 ppm) minus Sodium fluoride (250 ppm) such that a positive difference favors Sodium fluoride (1426 ppm).|||7.48|2.38|0.0002
70868516|NCT02195583|141223332|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.25||||0.0013|TWO_SIDED|95.0|1.68|6.82|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1150 ppm) minus Sodium fluoride (250 ppm) such that a positive difference favors Sodium fluoride (1150 ppm).|||6.82|1.68|0.0013
70868517|NCT02195583|141223332|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.71|||<|0.0001|TWO_SIDED|95.0|5.2|10.21|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1426 ppm) minus Sodium fluoride (0 ppm) such that a positive difference favors Sodium fluoride (1426 ppm).|||10.21|5.20|<0.0001
70868518|NCT02195583|141223332|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.03|||<|0.0001|TWO_SIDED|95.0|4.51|9.55|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1150 ppm) minus Sodium fluoride (0 ppm) such that a positive difference favors Sodium fluoride (1150 ppm).|||9.55|4.51|<0.0001
70868519|NCT02195583|141223332|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.78||||0.0325|TWO_SIDED|95.0|0.23|5.32|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (250 ppm) minus Sodium fluoride (0 ppm) such that a positive difference favors Sodium fluoride (250 ppm).|||5.32|0.23|0.0325
70868520|NCT02195583|141223332|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.16||||0.092|TWO_SIDED|95.0|-4.67|0.35|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as 'Sodium fluoride (1426 ppm) + zinc base A' minus Sodium fluoride (0 ppm) such that a positive difference favors 'Sodium fluoride (1426 ppm) + zinc base A'.|||0.35|-4.67|0.0920
70951072|NCT02209181|141403155|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.83|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|1.56|4.1||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.10|1.56|<0.001
70868521|NCT02195583|141223332|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.56||||0.2185|TWO_SIDED|95.0|-4.04|0.93|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as 'Sodium fluoride (1426 ppm) + zinc base B' minus Sodium fluoride (0 ppm) such that a positive difference favors 'Sodium fluoride (1426 ppm) + zinc base B'.|||0.93|-4.04|0.2185
70868522|NCT02195583|141223332|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.87|||<|0.0001|TWO_SIDED|95.0|7.36|12.37|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1426 ppm) minus 'Sodium fluoride (1426 ppm) + zinc base A' such that a positive difference favors Sodium fluoride (1426 ppm).|||12.37|7.36|<0.0001
70868523|NCT02195583|141223332|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.26|||<|0.0001|TWO_SIDED|95.0|6.77|11.75|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1426 ppm) minus 'Sodium fluoride (1426ppm) + zinc base B' such that a positive difference favors Sodium fluoride (1426 ppm).|||11.75|6.77|<0.0001
71142772|NCT00467740|141779262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.054||0.2832||95.0|-0.048|0.164|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.164|-0.048|0.2832
71142773|NCT00467740|141779262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.054||0.6516||95.0|-0.081|0.13|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.130|-0.081|0.6516
71142774|NCT00467740|141779262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.053||0.006||95.0|0.042|0.252|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.252|0.042|0.0060
71142775|NCT00467740|141779263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.05||0.0005||95.0|0.079|0.277|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.277|0.079|0.0005
71142776|NCT00467740|141779263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.051||0.007||95.0|0.038|0.237|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.237|0.038|0.0070
71142777|NCT00467740|141779263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.05||0.0512||95.0|-0.001|0.198|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.198|-0.001|0.0512
71142778|NCT00467740|141779263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.133|0.331|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.331|0.133|<0.0001
71142779|NCT00467740|141779264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.061||0.1811||95.0|-0.039|0.203|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.203|-0.039|0.1811
71142780|NCT00467740|141779264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.062||0.2118||95.0|-0.044|0.199|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.199|-0.044|0.2118
71142781|NCT00467740|141779264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|STANDARD_ERROR_OF_MEAN|0.062||0.5504||95.0|-0.085|0.158|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.158|-0.085|0.5504
71142782|NCT00467740|141779264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.191|STANDARD_ERROR_OF_MEAN|0.062||0.0022||95.0|0.069|0.312|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.312|0.069|0.0022
71142783|NCT00467740|141779265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.102|0.255|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.255|0.102|<0.0001
71142784|NCT00467740|141779265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.106|0.26|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.260|0.106|<0.0001
71142785|NCT00467740|141779265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.096|0.25|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.250|0.096|<0.0001
71142786|NCT00467740|141779265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.291|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.214|0.367|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.367|0.214|<0.0001
70868524|NCT01709513|141223336|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-30.4|||<|0.0001|TWO_SIDED|95.0|-36.6|-24.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Alirocumab group was compared to the corresponding active control group using an appropriate contrast statement.||-24.2|-36.6|<0.0001
71142787|NCT00467740|141779266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001||95.0|0.101|0.279|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.279|0.101|<0.0001
71142788|NCT00467740|141779266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.196|STANDARD_ERROR_OF_MEAN|0.046|<|0.0001||95.0|0.107|0.286|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.286|0.107|<0.0001
70872241|NCT00407797|141229711|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0898|TWO_SIDED||||||t-test, 2 sided|||LOCF: 9-Item Overall Sleep Problem Index. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0898
70868525|NCT01709513|141223337|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-35.1|||<|0.0001|TWO_SIDED|95.0|-40.7|-29.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 5% level.||-29.5|-40.7|<0.0001
71142789|NCT00467740|141779266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157|STANDARD_ERROR_OF_MEAN|0.045||0.0007||95.0|0.067|0.246|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.246|0.067|0.0007
71142790|NCT00467740|141779266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.263|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001||95.0|0.174|0.352|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.352|0.174|<0.0001
71142791|NCT00467740|141779267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.214|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.115|0.313|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.313|0.115|<0.0001
71142792|NCT00467740|141779267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.05||0.0021||95.0|0.057|0.255|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.255|0.057|0.0021
71142793|NCT00467740|141779267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.05||0.0795||95.0|-0.01|0.187|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.187|-0.010|0.0795
71142794|NCT00467740|141779267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.227|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.129|0.326|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.326|0.129|<0.0001
71142795|NCT00467740|141779268|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.179|STANDARD_ERROR_OF_MEAN|0.049||0.0003||95.0|0.082|0.276|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.276|0.082|0.0003
71142796|NCT00467740|141779268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.049||0.0077||95.0|0.035|0.229|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.229|0.035|0.0077
71142797|NCT00467740|141779268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.049||0.0427||95.0|0.003|0.197|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.197|0.003|0.0427
71142798|NCT00467740|141779268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001||95.0|0.143|0.336|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.336|0.143|<0.0001
71142799|NCT00467740|141779269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.048||0.0005||95.0|0.074|0.263|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.263|0.074|0.0005
71142800|NCT00467740|141779269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.048||0.0003||95.0|0.08|0.269|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.269|0.080|0.0003
71142801|NCT00467740|141779269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.048||0.0004||95.0|0.078|0.268|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.268|0.078|0.0004
71142802|NCT00467740|141779269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.296|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001||95.0|0.202|0.39|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.390|0.202|<0.0001
70951073|NCT02209181|141403155|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.88|STANDARD_ERROR_OF_MEAN|0.64||0.17|TWO_SIDED|95.0|-0.38|2.14||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.14|-0.38|0.170
70951074|NCT02209181|141403155|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.6|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|2.33|4.87||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.87|2.33|<0.001
70951075|NCT02209181|141403155|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.95|STANDARD_ERROR_OF_MEAN|0.64||0.002|TWO_SIDED|95.0|-3.21|-0.69||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.69|-3.21|0.002
70951076|NCT02209181|141403155|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.77|STANDARD_ERROR_OF_MEAN|0.65||0.235|TWO_SIDED|95.0|-0.5|2.04||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.04|-0.50|0.235
70951077|NCT02209181|141403156|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|0.65||0.001|TWO_SIDED|95.0|0.82|3.39||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.39|0.82|0.001
70951078|NCT02209181|141403156|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.65||0.355|TWO_SIDED|95.0|-0.68|1.87||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.87|-0.68|0.355
71142803|NCT00467740|141779270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.048||0.0004||95.0|0.078|0.268|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.268|0.078|0.0004
71142804|NCT00467740|141779270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.048||0.0002||95.0|0.09|0.281|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.281|0.090|0.0002
71142805|NCT00467740|141779270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.048||0.0047||95.0|0.043|0.233|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.233|0.043|0.0047
71142806|NCT00467740|141779270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.237|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001||95.0|0.142|0.332|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.332|0.142|<0.0001
70951079|NCT02209181|141403156|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.36|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|2.07|4.65||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.65|2.07|<0.001
70951080|NCT02209181|141403156|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.65||0.021|TWO_SIDED|95.0|-2.78|-0.23||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.23|-2.78|0.021
70951081|NCT02209181|141403156|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.26|STANDARD_ERROR_OF_MEAN|0.65||0.056|TWO_SIDED|95.0|-0.03|2.55||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.55|-0.03|0.056
70951082|NCT02209181|141403157|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.21|STANDARD_ERROR_OF_MEAN|0.66||0.067|TWO_SIDED|95.0|-0.09|2.5||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.50|-0.09|0.067
70951083|NCT02209181|141403157|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.65||0.547|TWO_SIDED|95.0|-0.89|1.68||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.68|-0.89|0.547
70951084|NCT02209181|141403157|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.16|STANDARD_ERROR_OF_MEAN|0.66|<|0.001|TWO_SIDED|95.0|1.86|4.46||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.46|1.86|<0.001
70951085|NCT02209181|141403157|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.65||0.214|TWO_SIDED|95.0|-2.1|0.47||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.47|-2.10|0.214
71142807|NCT00467740|141779271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.055||0.0002||95.0|0.096|0.312|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.312|0.096|0.0002
71142808|NCT00467740|141779271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.153|STANDARD_ERROR_OF_MEAN|0.055||0.0057||95.0|0.045|0.261|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.261|0.045|0.0057
70951086|NCT02209181|141403157|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.96|STANDARD_ERROR_OF_MEAN|0.66||0.003|TWO_SIDED|95.0|0.66|3.26||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.26|0.66|0.003
70951087|NCT02209181|141403158|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.64||0.281|TWO_SIDED|95.0|-0.57|1.95||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.95|-0.57|0.281
70951088|NCT02209181|141403158|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.63||0.729|TWO_SIDED|95.0|-1.03|1.47||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.47|-1.03|0.729
70951089|NCT02209181|141403158|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.21|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|1.95|4.47||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.47|1.95|<0.001
70951090|NCT02209181|141403158|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.63||0.459|TWO_SIDED|95.0|-1.72|0.78||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.78|-1.72|0.459
70951091|NCT02209181|141403158|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.52|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|1.26|3.78||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.78|1.26|<0.001
71142809|NCT00467740|141779271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.055||0.1513||95.0|-0.029|0.186|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.186|-0.029|0.1513
71142810|NCT00467740|141779271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.221|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001||95.0|0.114|0.328|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.328|0.114|<0.0001
71142811|NCT00467740|141779272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.054||0.0022||95.0|0.06|0.271|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.271|0.060|0.0022
70951092|NCT02209181|141403159|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.65||0.674|TWO_SIDED|95.0|-1.0|1.55||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.55|-1.00|0.674
70951093|NCT02209181|141403159|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.64||0.417|TWO_SIDED|95.0|-0.74|1.79||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.79|-0.74|0.417
70951094|NCT02209181|141403159|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.05|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|1.77|4.33||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.33|1.77|<0.001
70951095|NCT02209181|141403159|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.64||0.698|TWO_SIDED|95.0|-1.02|1.52||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.52|-1.02|0.698
70951096|NCT02209181|141403159|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.77|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|1.49|4.05||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.05|1.49|<0.001
70951097|NCT02209181|141403160|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.64||0.541|TWO_SIDED|95.0|-0.87|1.66||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.66|-0.87|0.541
70951098|NCT02209181|141403160|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.64||0.409|TWO_SIDED|95.0|-0.73|1.79||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.79|-0.73|0.409
71142812|NCT00467740|141779272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.054||0.0307||95.0|0.011|0.223|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.223|0.011|0.0307
71142813|NCT00467740|141779272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.054||0.132||95.0|-0.025|0.187|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.187|-0.025|0.1320
71142814|NCT00467740|141779272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.054|<|0.0001||95.0|0.127|0.337|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.337|0.127|<0.0001
71142815|NCT00467740|141779273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.056||0.1585||95.0|-0.031|0.188|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.188|-0.031|0.1585
70868526|NCT01709513|141223338|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-31.5|||<|0.0001|TWO_SIDED|95.0|-36.9|-26.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-26.1|-36.9|<0.0001
71142816|NCT00467740|141779273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.056||0.0848||95.0|-0.013|0.207|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.207|-0.013|0.0848
71142817|NCT00467740|141779273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.056||0.0838||95.0|-0.013|0.207|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.207|-0.013|0.0838
71142818|NCT00467740|141779273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.056||0.0014||95.0|0.07|0.289|||Mixed Models Analysis||Olo 20 mcg qd minus Placebo|||0.289|0.070|0.0014
71142819|NCT00467740|141779274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.059||0.0959||95.0|-0.018|0.216|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.216|-0.018|0.0959
71142820|NCT00467740|141779274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.06||0.047||95.0|0.002|0.237|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.237|0.002|0.0470
71142821|NCT00467740|141779274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.06||0.196||95.0|-0.04|0.195|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.195|-0.040|0.1960
71142822|NCT00467740|141779274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.059||0.002||95.0|0.068|0.302|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.302|0.068|0.0020
71142823|NCT00467740|141779275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.064||0.027||95.0|0.016|0.269|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.269|0.016|0.0270
71142824|NCT00467740|141779275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.065||0.1031||95.0|-0.021|0.233|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.233|-0.021|0.1031
71142825|NCT00467740|141779275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.064||0.4378||95.0|-0.077|0.177|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.177|-0.077|0.4378
71142826|NCT00467740|141779275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.064||0.0064||95.0|0.05|0.303|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.303|0.050|0.0064
71142827|NCT00467740|141779276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|0.069||0.2781||95.0|-0.061|0.21|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.210|-0.061|0.2781
71142828|NCT00467740|141779276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.069||0.3284||95.0|-0.068|0.204|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.204|-0.068|0.3284
71142829|NCT00467740|141779276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036|STANDARD_ERROR_OF_MEAN|0.069||0.602||95.0|-0.1|0.171|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.171|-0.100|0.6020
71142830|NCT00467740|141779276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.069||0.0006||95.0|0.104|0.375|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.375|0.104|0.0006
71142831|NCT00467740|141779277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|STANDARD_ERROR_OF_MEAN|0.067||0.4331|TWO_SIDED|95.0|-0.079|0.184|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.184|-0.079|0.4331
71142832|NCT00467740|141779277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.068||0.515|TWO_SIDED|95.0|-0.089|0.178|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.178|-0.089|0.5150
70868527|NCT01709513|141223339|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-33.1|||<|0.0001|TWO_SIDED|95.0|-38.0|-28.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-28.2|-38.0|<0.0001
71142833|NCT00467740|141779277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038|STANDARD_ERROR_OF_MEAN|0.068||0.5714|TWO_SIDED|95.0|-0.095|0.171|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.171|-0.095|0.5714
70951099|NCT02209181|141403160|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.12|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|1.85|4.39||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.39|1.85|<0.001
71142834|NCT00467740|141779277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.068||0.0177|TWO_SIDED|95.0|0.028|0.296|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.296|0.028|0.0177
70951100|NCT02209181|141403160|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.64||0.834|TWO_SIDED|95.0|-1.12|1.39||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.39|-1.12|0.834
70951101|NCT02209181|141403160|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.73|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|1.45|4.0||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.00|1.45|<0.001
71142835|NCT00467740|141779278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.97|STANDARD_ERROR_OF_MEAN|7.665||0.003|TWO_SIDED|95.0|7.883|38.057|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||38.057|7.883|0.0030
71142836|NCT00467740|141779278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.6|STANDARD_ERROR_OF_MEAN|7.7||0.0016|TWO_SIDED|95.0|9.446|39.754|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||39.754|9.446|0.0016
71142837|NCT00467740|141779278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.806|STANDARD_ERROR_OF_MEAN|7.727|<|0.0001|TWO_SIDED|95.0|21.598|52.015|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||52.015|21.598|<.0001
71142838|NCT00467740|141779278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.505|STANDARD_ERROR_OF_MEAN|7.675|<|0.0001|TWO_SIDED|95.0|27.399|57.611|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||57.611|27.399|<.0001
71142839|NCT00467740|141779279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.118|STANDARD_ERROR_OF_MEAN|1.055||0.2898|TWO_SIDED|95.0|-3.194|0.957|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.957|-3.194|0.2898
71142840|NCT00467740|141779279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.351|STANDARD_ERROR_OF_MEAN|1.057||0.027|TWO_SIDED|95.0|-4.432|-0.269|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||-0.269|-4.432|0.0270
71142841|NCT00467740|141779279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.045|STANDARD_ERROR_OF_MEAN|1.063||0.0045|TWO_SIDED|95.0|-5.138|-0.952|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||-0.952|-5.138|0.0045
71142842|NCT00467740|141779279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.937|STANDARD_ERROR_OF_MEAN|1.053||0.0056|TWO_SIDED|95.0|-5.01|-0.865|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||-0.865|-5.010|0.0056
71142843|NCT00467740|141779280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.287|STANDARD_ERROR_OF_MEAN|0.257||0.2645|TWO_SIDED|95.0|-0.793|0.218|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.218|-0.793|0.2645
71142844|NCT00467740|141779280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.526|STANDARD_ERROR_OF_MEAN|0.258||0.0423|TWO_SIDED|95.0|-1.034|-0.018|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||-0.018|-1.034|0.0423
71142845|NCT00467740|141779280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.332|STANDARD_ERROR_OF_MEAN|0.259||0.2008|TWO_SIDED|95.0|-0.842|0.178|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.178|-0.842|0.2008
71142846|NCT00467740|141779280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.593|STANDARD_ERROR_OF_MEAN|0.257||0.0218|TWO_SIDED|95.0|-1.098|-0.087|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||-0.087|-1.098|0.0218
71142847|NCT00467740|141779289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.142|STANDARD_ERROR_OF_MEAN|0.114||0.2156||95.0|-0.368|0.083|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.083|-0.368|0.2156
71142848|NCT00467740|141779289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.197|STANDARD_ERROR_OF_MEAN|0.114||0.0869||95.0|-0.422|0.029|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.029|-0.422|0.0869
70868528|NCT01709513|141223340|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.1|||<|0.0001|TWO_SIDED|95.0|-29.8|-20.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-20.4|-29.8|<0.0001
71142849|NCT00467740|141779289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.328|STANDARD_ERROR_OF_MEAN|0.114||0.0044||95.0|-0.552|-0.103|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||-0.103|-0.552|0.0044
71142850|NCT00467740|141779289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.276|STANDARD_ERROR_OF_MEAN|0.113||0.0158||95.0|-0.499|-0.052|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||-0.052|-0.499|0.0158
70951102|NCT02209181|141403161|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.64||0.573|TWO_SIDED|95.0|-0.9|1.63||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.63|-0.90|0.573
71142851|NCT03535974|141779292|OTHER||Mean Difference (Final Values)|10.57|STANDARD_ERROR_OF_MEAN|5.122||0.047|TWO_SIDED||||||t-test, 2 sided|||||||0.047
71142852|NCT04999839|141779318|SUPERIORITY||Odds Ratio (OR)|3.727|||=|0.052|TWO_SIDED|95.0|0.933|14.885||P-value was calculated using a Cochran-Mantel-Haenszel (CMH) test, with prior treatment with biologics included as a stratification factor, comparing the percentage of participants in each dose of NDI-034858 vs placebo.|Cochran-Mantel-Haenszel||Odds ratio for achievement of PASI-75 was calculated using the Mantel-Haenszel (MH) method.|||14.885|0.933|=0.052
71142853|NCT04999839|141779318|SUPERIORITY||Odds Ratio (OR)|12.733|||<|0.001|TWO_SIDED|95.0|3.525|45.994||P-value was calculated using a CMH test, with prior treatment with biologics included as a stratification factor, comparing the percentage of participants in each dose of NDI-034858 vs placebo.|Cochran-Mantel-Haenszel||Odds ratio for achievement of PASI-75 was calculated using the MH method.|||45.994|3.525|<0.001
71142854|NCT04999839|141779318|SUPERIORITY||Odds Ratio (OR)|29.014|||<|0.001|TWO_SIDED|95.0|8.526|98.735||P-value was calculated using a CMH test, with prior treatment with biologics included as a stratification factor, comparing the percentage of participants in each dose of NDI-034858 vs placebo.|Cochran-Mantel-Haenszel||Odds ratio for achievement of PASI-75 was calculated using the MH method.|||98.735|8.526|<0.001
71142855|NCT04999839|141779318|SUPERIORITY||Odds Ratio (OR)|40.111|||<|0.001|TWO_SIDED|95.0|10.277|156.548||P-value was calculated using a CMH test, with prior treatment with biologics included as a stratification factor, comparing the percentage of participants in each dose of NDI-034858 vs placebo.|Cochran-Mantel-Haenszel||Odds ratio for achievement of PASI-75 was calculated using the MH method.|||156.548|10.277|<0.001
71142856|NCT00539981|141779357|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot A vs. B falls within 0.67 to 1.5.|GMT ratio|1.07||||0.009|TWO_SIDED|95.0|0.85|1.36||Threshold for significance of p value was 0.05.|ANOVA|||A/Solomon Islands (H1N1): FluBlok: Lot A versus FluBlok: Lot B||1.36|0.85|0.009
71142857|NCT00539981|141779357|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot A vs. C falls within 0.67 to 1.5.|GMT ratio|0.91||||0.009|TWO_SIDED|0.91|0.71|1.15||Threshold for significance of p value was 0.05.|ANOVA|||A/Solomon Islands (H1N1): FluBlok: Lot A versus FluBlok: Lot C||1.15|0.71|0.009
71142858|NCT00539981|141779357|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot B vs. C falls within 0.67 to 1.5.|GMT ratio|0.85||||0.009|TWO_SIDED|95.0|0.67|1.07|||ANOVA|Threshold for significance of p value was 0.05.||A/Solomon Islands (H1N1): FluBlok: Lot B versus FluBlok: Lot C||1.07|0.67|0.009
71142859|NCT00539981|141779357|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot A vs. B falls within 0.67 to 1.5.|GMT ratio|2.03||||0.065|TWO_SIDED|95.0|1.56|2.64||Threshold of significance for p value was 0.05.|ANOVA|||A/Wisconsin (H3N2): FluBlok: Lot A versus FluBlok: Lot B||2.64|1.56|0.065
71142860|NCT00539981|141779357|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot A vs. C falls within 0.67 to 1.5.|GMT ratio|1.63||||0.065|TWO_SIDED|95.0|1.26|2.11|||ANOVA|Threshold of significance for p value was 0.05.||A/Wisconsin (H3N2): FluBlok: Lot A versus FluBlok: Lot C||2.11|1.26|0.065
71142861|NCT00539981|141779357|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot B vs. C falls within 0.67 to 1.5.|GMT ratio|0.8||||0.065|TWO_SIDED|95.0|0.62|1.04|||ANOVA|Threshold of significance for p value was 0.05.||A/Wisconsin (H3N2): FluBlok: Lot B versus FluBlok: Lot C||1.04|0.62|0.065
71142862|NCT00539981|141779357|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot A vs. B falls within 0.67 to 1.5.|GMT ratio|0.88||||0.011|TWO_SIDED|95.0|0.69|1.13|||ANOVA|Threshold of significance for p value was 0.05.||B/Malaysia: FluBlok: Lot A versus FluBlok: Lot B||1.13|0.69|0.011
71142863|NCT00539981|141779357|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot A vs. C falls within 0.67 to 1.5.|GMT ratio|0.85||||0.011|TWO_SIDED|95.0|0.65|1.09|||ANOVA|Threshold of significance for p value was 0.05.||B/Malaysia: FluBlok: Lot A versus FluBlok: Lot C||1.09|0.65|0.011
71142864|NCT00539981|141779357|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot B vs. C falls within 0.67 to 1.5.|GMT ratio|0.96||||0.011|TWO_SIDED|95.0|0.75|1.23|||ANOVA|Threshold of significance for p value was 0.05.||B/Malaysia: FluBlok: Lot B versus FluBlok: Lot C||1.23|0.75|0.011
71142865|NCT00539981|141779358|SUPERIORITY|Relative protective efficacy is equivalent to absolute efficacy which is defined as the reduction in the influenza rate for Flublok relative to placebo.|Relative protective efficacy|75.4|||||TWO_SIDED|95.0|-148.0|99.5||||||FluBlok versus Placebo||99.5|-148.0|
71142866|NCT02675907|141779361|SUPERIORITY|||||||0.0034|||||||t-test, 2 sided|||||||0.0034
71142867|NCT02675907|141779362|SUPERIORITY||||||<|0.05||||||Row 1 (SPID6)|t-test, 2 sided|||||||<0.05
71142868|NCT02675907|141779362|SUPERIORITY||||||<|0.01||||||Row 2 (SPID12)|t-test, 2 sided|||||||<0.01
71142869|NCT02675907|141779362|SUPERIORITY||||||<|0.01||||||Row 3 (SPID24)|t-test, 2 sided|||||||<0.01
71142870|NCT02675907|141779362|SUPERIORITY||||||<|0.01||||||Row 4 (SPID12-48)|t-test, 2 sided|||||||<0.01
71142871|NCT02675907|141779362|SUPERIORITY||||||<|0.01||||||Row 5 (SPID24-48)|t-test, 2 sided|||||||<0.01
71142872|NCT02675907|141779363|SUPERIORITY|||||||0.0076|||||||Log Rank|||||||0.0076
71142873|NCT02675907|141779364|SUPERIORITY||||||<|0.001||||||Row 1 (Hour 0-24)|Cochran-Mantel-Haenszel|||||||<0.001
71142874|NCT02675907|141779364|SUPERIORITY||||||<|0.01||||||Row 2 (Hour 24-48)|Cochran-Mantel-Haenszel|||||||<0.01
71142875|NCT02675907|141779364|SUPERIORITY||||||<|0.01||||||Row 3 (Hour 0-48)|Cochran-Mantel-Haenszel|||||||<0.01
71142876|NCT02675907|141779365|SUPERIORITY||||||<|0.05||||||Row 1 (Hour 0-24)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site||||||<0.05
70951103|NCT02209181|141403161|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|0.64||0.448|TWO_SIDED|95.0|-0.77|1.74||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.74|-0.77|0.448
70951104|NCT02209181|141403161|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.98|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|1.71|4.25||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.25|1.71|<0.001
70951105|NCT02209181|141403161|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.64||0.848|TWO_SIDED|95.0|-1.13|1.38||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.38|-1.13|0.848
70951106|NCT02209181|141403161|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.62|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|1.35|3.89||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.89|1.35|<0.001
70951107|NCT02209181|141403162|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.64||0.72|TWO_SIDED|95.0|-1.04|1.5||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.50|-1.04|0.720
70951108|NCT02209181|141403162|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.64||0.763|TWO_SIDED|95.0|-1.07|1.45||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.45|-1.07|0.763
71142877|NCT02675907|141779365|SUPERIORITY||||||<|0.05||||||Row 2 (Hour 24-48)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site||||||<0.05
70868529|NCT01709513|141223341|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.2|||<|0.0001|TWO_SIDED|95.0|-32.1|-24.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-24.4|-32.1|<0.0001
70868530|NCT01709513|141223342|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.6|||<|0.0001|TWO_SIDED|95.0|-30.4|-20.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-20.8|-30.4|<0.0001
70951109|NCT02209181|141403162|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.82|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|1.55|4.09||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.09|1.55|<0.001
70951110|NCT02209181|141403162|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.64||0.952|TWO_SIDED|95.0|-1.3|1.22||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.22|-1.30|0.952
70951111|NCT02209181|141403162|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.59|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|1.31|3.86||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.86|1.31|<0.001
70951112|NCT02209181|141403163|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.63||0.821|TWO_SIDED|95.0|-1.1|1.39||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.39|-1.10|0.821
71142878|NCT02675907|141779365|SUPERIORITY||||||<|0.05||||||Row 3 (Hour 0-48)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site||||||<0.05
71142879|NCT02675907|141779366|SUPERIORITY|||||||0.1228|||||||Log Rank|||||||0.1228
71142880|NCT02675907|141779367|SUPERIORITY|||||||0.1048|||||||Log Rank|||||||0.1048
71142881|NCT02675907|141779368|SUPERIORITY|||||||0.0451|||||||Cochran-Mantel-Haenszel|||||||0.0451
70951113|NCT02209181|141403163|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.63||0.978|TWO_SIDED|95.0|-1.25|1.22||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.22|-1.25|0.978
70951114|NCT02209181|141403163|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.88|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|1.63|4.13||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.13|1.63|<0.001
71142882|NCT02675907|141779369|SUPERIORITY|||||||0.0107|||||||Cochran-Mantel-Haenszel|||||||0.0107
71142883|NCT02675907|141779370|SUPERIORITY|||||||0.0781|||||||Cochran-Mantel-Haenszel|||||||0.0781
71142884|NCT02675907|141779371|SUPERIORITY|||||||0.043|||||||Cochran-Mantel-Haenszel|||||||0.0430
71142885|NCT02675907|141779372|SUPERIORITY|||||||0.107|||||||Cochran-Mantel-Haenszel|P-value was derived from comparisons between N1539 and Placebo via General Association of CMH Test controlling for investigational site||||||0.1070
71142886|NCT02675907|141779373|SUPERIORITY|||||||0.0046|||||||Cochran-Mantel-Haenszel|P-value was derived from comparisons between N1539 and Placebo via General Association of CMH Test controlling for investigational site||||||0.0046
71142887|NCT01611792|141779374|SUPERIORITY||Mean Difference (Net)|-10.0|STANDARD_DEVIATION|9.02|<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<.0001
71142888|NCT01611792|141779375|SUPERIORITY||Mean Difference (Net)|-6.67|STANDARD_DEVIATION|11.86||0.0038|TWO_SIDED||||||Mixed Models Analysis|||||||0.0038
70951115|NCT02209181|141403163|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.63||0.799|TWO_SIDED|95.0|-1.39|1.07||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.07|-1.39|0.799
70951116|NCT02209181|141403163|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.73|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|1.49|3.98||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.98|1.49|<0.001
71142889|NCT01611792|141779376|SUPERIORITY||Mean Difference (Net)|2.0|STANDARD_DEVIATION|5.36||0.36|TWO_SIDED||||||Mixed Models Analysis|||||||0.36
70951117|NCT02209181|141403164|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.7||0.726|TWO_SIDED|95.0|-1.62|1.13||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.13|-1.62|0.726
70951118|NCT02209181|141403164|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.69||0.869|TWO_SIDED|95.0|-1.48|1.25||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.25|-1.48|0.869
71142890|NCT01611792|141779377|SUPERIORITY||Mean Difference (Net)|-1.31|STANDARD_DEVIATION|1.98||0.0018|TWO_SIDED||||||Mixed Models Analysis|||||||0.0018
71142891|NCT01611792|141779378|SUPERIORITY||Mean Difference (Net)|0.69|STANDARD_DEVIATION|2.12||0.19|TWO_SIDED||||||Mixed Models Analysis|||||||0.19
71142892|NCT01611792|141779379|SUPERIORITY||Mean Difference (Net)|0.69|STANDARD_DEVIATION|2.12||0.19|TWO_SIDED||||||Mixed Models Analysis|||||||0.19
71142893|NCT02898454|141779396|SUPERIORITY||LS mean difference|-0.87|||<|0.0001|TWO_SIDED|95.0|-1.03|-0.71|||ANCOVA|||Data was analyzed using a hybrid method of the worst-observation carried forward (WOCF) and multiple imputation (MI). The imputed completed data were analyzed by fitting ANCOVA model with the corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-0.71|-1.03|<0.0001
71142894|NCT02898454|141779397|SUPERIORITY||LS mean difference|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.1|-1.51|||ANCOVA|||Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-1.51|-2.10|<0.0001
71142895|NCT02898454|141779398|SUPERIORITY|Hierarchical testing procedure was used to control type I error. For regions outside of Japan, this first secondary endpoint was not tested unless both co-primary endpoints were significant at the 0.05 level. Hierarchical testing continued only when previous endpoint was statistically significant. For Japan submission, LMK was instead a co-primary endpoint which also had to be met before secondary endpoints were tested in the hierarchy. Last endpoint in hierarchy is Week 52 SNOT-22.|LS mean difference|-5.13|||<|0.0001|TWO_SIDED|95.0|-5.8|-4.46||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-4.46|-5.80|<0.0001
71142896|NCT02898454|141779399|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-2.44|||<|0.0001|TWO_SIDED|95.0|-2.87|-2.02||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-2.02|-2.87|<0.0001
71142897|NCT02898454|141779400|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|10.52|||<|0.0001|TWO_SIDED|95.0|8.98|12.07||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||12.07|8.98|<0.0001
71142898|NCT02898454|141779401|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.15|-0.81||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-0.81|-1.15|<0.0001
70951119|NCT02209181|141403164|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.52|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|1.13|3.9||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.90|1.13|<0.001
70951120|NCT02209181|141403164|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.69||0.851|TWO_SIDED|95.0|-1.24|1.5||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.50|-1.24|0.851
71142899|NCT02898454|141779402|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-17.36|||<|0.0001|TWO_SIDED|95.0|-20.87|-13.85||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-13.85|-20.87|<0.0001
71142900|NCT02898454|141779403|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-2.21|||<|0.0001|TWO_SIDED|95.0|-2.59|-1.83||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w then q4w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-1.83|-2.59|<0.0001
71142901|NCT02898454|141779403|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-2.41|||<|0.0001|TWO_SIDED|95.0|-2.78|-2.03||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-2.03|-2.78|<0.0001
71142902|NCT02898454|141779404|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-1.11|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.92||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w then q4w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-0.92|-1.30|<0.0001
71142903|NCT02898454|141779404|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-0.99|||<|0.0001|TWO_SIDED|95.0|-1.18|-0.8||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-0.80|-1.18|<0.0001
71142904|NCT02898454|141779405|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-21.36|||<|0.0001|TWO_SIDED|95.0|-25.45|-17.27||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w then q4w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-17.27|-25.45|<0.0001
71142905|NCT02898454|141779405|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-20.73|||<|0.0001|TWO_SIDED|95.0|-24.81|-16.65||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-16.65|-24.81|<0.0001
71142906|NCT01601535|141779448|OTHER|||||||0.14||||||MYCN Amplified vs. MYCN not Amplified|Fisher Exact|||||||0.14
71142907|NCT01601535|141779448|OTHER|||||||0.21|||||||Fisher Exact|MYCN Amplified or Myc Positive vs. MYCN Non-amplified and Myc Negative||||||0.21
71142908|NCT01601535|141779448|OTHER|||||||1|||||||Fisher Exact|Aurora A protein Positive vs. Aurora A protein Negative||||||1.0
71142909|NCT01601535|141779449|OTHER|||||||0.094||||||UGT1A1 6\\6 vs. UGT1A1 6\\7 vs. UGT1A1 7\\7|Fisher Exact|||||||0.094
71142910|NCT01601535|141779449|OTHER|||||||0.63||||||UGT1A1 6\\6 vs. UGT1A1 6\\7 vs. UGT1A1 7\\7|Fisher Exact|||||||0.63
71142911|NCT01601535|141779450|OTHER|||||||0.9||||||AurkA Codon 31 Summary H vs. AurkA Codon 31 Summary V vs. AurkA Codon 31 Summary W|Fisher Exact|||||||0.90
71142912|NCT01601535|141779450|OTHER|||||||1||||||AurkA Codon 57 Summary H vs. AurkA Codon 57 Summary W|Fisher Exact|||||||1.0
71142913|NCT00795704|141779460|SUPERIORITY_OR_OTHER|||||||0.079|||||||t-test, 2 sided|||||||0.079
71142914|NCT00795704|141779462|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71142915|NCT03980730|141779463|SUPERIORITY|||||||0.2057|||||||Mixed Models Analysis|||||||0.2057
71142916|NCT03125226|141779473|OTHER|Single group mean and standard deviation||||||||||||||||Coordinates in x/y/z planes were assigned to each hydrogel marker on the planning CT and daily CBCT to calculate interfraction motion.|Single group mean and standard deviation|||
71142917|NCT03125226|141779478|OTHER|The Van Herk (VH) margin equation for the planning target volume margin, as a function of systemic and random errors, was calculated such that the CTV receives at least 95%-prescription dose in 90% of patients.|||||||||||||||||The Van Herk (VH) margin equation for the planning target volume margin, as a function of systemic and random errors, was calculated such that the CTV receives at least 95%-prescription dose in 90% of patients.|||
71142918|NCT03883581|141779479|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
71142919|NCT03883581|141779480|SUPERIORITY|||||||0.647|||||||Paired t test|||||||0.647
71142920|NCT03883581|141779481|SUPERIORITY|||||||0.103|||||||Paired t test|||||||0.103
71142921|NCT03883581|141779482|SUPERIORITY|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|||||||0.0004
71142922|NCT03883581|141779483|SUPERIORITY|||||||0.103|||||||Paired t test|||||||0.103
71142923|NCT04612725|141779484|SUPERIORITY||LS mean difference|-1.01||||0.3824|TWO_SIDED|95.0|-3.28|1.26||Change from baseline in ISS7 at Week 12= Treatment + baseline ISS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.26|-3.28|0.3824
71142924|NCT04612725|141779484|SUPERIORITY||LS mean difference|-1.79||||0.1244|TWO_SIDED|95.0|-4.09|0.5||Change from baseline in ISS7 at Week 12= Treatment + baseline ISS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||0.50|-4.09|0.1244
71142925|NCT04612725|141779485|SUPERIORITY||LS mean difference|-2.07||||0.4016|TWO_SIDED|95.0|-6.95|2.8||Change from baseline in UAS7 at Week 12= Treatment + baseline UAS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||2.80|-6.95|0.4016
71142926|NCT04612725|141779485|SUPERIORITY||LS mean difference|-4.36||||0.0819|TWO_SIDED|95.0|-9.28|0.56||Change from baseline in UAS7 at Week 12= Treatment + baseline UAS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||0.56|-9.28|0.0819
70868531|NCT01709513|141223343|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-29.8|||<|0.0001|TWO_SIDED|95.0|-33.9|-25.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-25.8|-33.9|<0.0001
71142927|NCT04612725|141779485|SUPERIORITY||LS mean difference|-2.56||||0.3314|TWO_SIDED|95.0|-7.74|2.63||Change from baseline in UAS7 at Week 24= Treatment + baseline UAS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||2.63|-7.74|0.3314
71142928|NCT04612725|141779485|SUPERIORITY||LS mean difference|-3.74||||0.1582|TWO_SIDED|95.0|-8.95|1.47||Change from baseline in UAS7 at Week 24= Treatment + baseline UAS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.47|-8.95|0.1582
71142929|NCT04612725|141779486|SUPERIORITY||LS mean difference|-1.62||||0.1995|TWO_SIDED|95.0|-4.1|0.86||Change from baseline in ISS7 at Week 24= Treatment + baseline ISS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||0.86|-4.10|0.1995
71142930|NCT04612725|141779486|SUPERIORITY||LS mean difference|-1.76||||0.1654|TWO_SIDED|95.0|-4.25|0.73||Change from baseline in ISS7 at Week 24= Treatment + baseline ISS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||0.73|-4.25|0.1654
71142931|NCT04612725|141779487|SUPERIORITY||percentage difference|11.72||||0.1373|TWO_SIDED|95.0|-2.37|25.82||Week 12: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||25.82|-2.37|0.1373
71142932|NCT04612725|141779487|SUPERIORITY||percentage difference|10.73||||0.1697|TWO_SIDED|95.0|-3.42|24.88||Week 12: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||24.88|-3.42|0.1697
71142933|NCT04612725|141779487|SUPERIORITY||percentage difference|1.03||||0.9105|TWO_SIDED|95.0|-16.9|18.96||Week 24: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||18.96|-16.90|0.9105
71142934|NCT04612725|141779487|SUPERIORITY||percentage difference|9.27||||0.3389|TWO_SIDED|95.0|-9.37|27.9||Week 24: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||27.90|-9.37|0.3389
71142935|NCT04612725|141779488|SUPERIORITY||LS mean difference|-1.16||||0.4203|TWO_SIDED|95.0|-4.0|1.68||Change from baseline in HSS7 at Week 12= Treatment + baseline HSS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.68|-4.00|0.4203
71142936|NCT04612725|141779488|SUPERIORITY||LS mean difference|-2.6||||0.0754|TWO_SIDED|95.0|-5.46|0.27||Change from baseline in HSS7 at Week 12= Treatment + baseline HSS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||0.27|-5.46|0.0754
71142937|NCT04612725|141779488|SUPERIORITY||LS mean difference|-1.06||||0.4772|TWO_SIDED|95.0|-4.01|1.89||Change from baseline in HSS7 at Week 24= Treatment + baseline HSS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.89|-4.01|0.4772
71142938|NCT04612725|141779488|SUPERIORITY||LS mean difference|-2.0||||0.1851|TWO_SIDED|95.0|-4.96|0.97||Change from baseline in HSS7 at Week 24= Treatment + baseline HSS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||0.97|-4.96|0.1851
71142939|NCT04612725|141779490|SUPERIORITY|||||||0.9678||||||Week 12: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||||0.9678
71142940|NCT04612725|141779490|SUPERIORITY|||||||0.3689||||||Week 12: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||||0.3689
71142941|NCT04612725|141779490|SUPERIORITY||percentage difference|-3.43||||0.6624|TWO_SIDED|95.0|-18.96|12.11||Week 24: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||12.11|-18.96|0.6624
71142942|NCT04612725|141779490|SUPERIORITY||percentage difference|0.28||||0.9726|TWO_SIDED|95.0|-15.84|16.4||Week 24: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||16.40|-15.84|0.9726
71142943|NCT04612725|141779492|SUPERIORITY||LS mean difference|-0.29||||0.7256|TWO_SIDED|95.0|-1.9|1.32||Change from baseline in UCT at Week 12= Treatment + baseline UCT + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.32|-1.90|0.7256
71142944|NCT04612725|141779492|SUPERIORITY||LS mean difference|1.09||||0.189|TWO_SIDED|95.0|-0.54|2.72||Change from baseline in UCT at Week 12= Treatment + baseline UCT + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||2.72|-0.54|0.1890
71142945|NCT04612725|141779492|SUPERIORITY||LS mean difference|-0.63||||0.5048|TWO_SIDED|95.0|-2.51|1.24||Change from baseline in UCT at Week 24= Treatment + baseline UCT + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.24|-2.51|0.5048
70951121|NCT02209181|141403164|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.76|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|1.38|4.15||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.15|1.38|<0.001
70951122|NCT02209181|141403165|SUPERIORITY_OR_OTHER|||||||0.042||||||The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.||||0.042
70951123|NCT02209181|141403165|SUPERIORITY_OR_OTHER|||||||0.779||||||The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.||||0.779
70951124|NCT02209181|141403165|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.||||<0.001
70951125|NCT02209181|141403165|SUPERIORITY_OR_OTHER|||||||0.196||||||The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.||||0.196
70951126|NCT02209181|141403165|SUPERIORITY_OR_OTHER|||||||0.006||||||The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.||||0.006
70951127|NCT02209181|141403166|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|1.1|1.9||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.9|1.1|<0.001
70951128|NCT02209181|141403166|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.21||0.077|TWO_SIDED|95.0|0.0|0.8||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.8|-0.0|0.077
70951129|NCT02209181|141403166|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|0.8|1.6||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.6|0.8|<0.001
70951130|NCT02209181|141403166|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|-1.6|-0.7||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.7|-1.6|<0.001
70951131|NCT02209181|141403166|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.148|TWO_SIDED|95.0|-0.7|0.1||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.1|-0.7|0.148
70868532|NCT01709513|141223344|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.8|||<|0.0001|TWO_SIDED|95.0|-24.7|-17.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-17.0|-24.7|<0.0001
70951132|NCT05239598|141403286|SUPERIORITY||Mean Difference (Net)|4.5||||0.287|TWO_SIDED|95.0|-4.0|13.0|||t-test, 2 sided|||||13.0|-4.0|0.287
71142946|NCT04612725|141779492|SUPERIORITY||LS mean difference|0.99||||0.2991|TWO_SIDED|95.0|-0.89|2.88||Change from baseline in UCT at Week 24= Treatment + baseline UCT + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||2.88|-0.89|0.2991
71142947|NCT04612725|141779493|SUPERIORITY||LS mean difference|1.63||||0.5704|TWO_SIDED|95.0|-4.05|7.32||Change from baseline in CU-Q2oL at Week 12= Treatment + baseline CU-Q2oL + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||7.32|-4.05|0.5704
71142948|NCT04612725|141779493|SUPERIORITY||LS mean difference|-2.24||||0.4416|TWO_SIDED|95.0|-7.98|3.5||Change from baseline in CU-Q2oL at Week 12= Treatment + baseline CU-Q2oL + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||3.50|-7.98|0.4416
70951133|NCT05239598|141403287|SUPERIORITY||Mean Difference (Net)|1.7||||0.625|TWO_SIDED|95.0|-5.2|8.6|||t-test, 2 sided|||5 minutes post intervention||8.6|-5.2|0.625
70951134|NCT05239598|141403287|SUPERIORITY||Mean Difference (Net)|2.5||||0.526|TWO_SIDED|95.0|-5.5|10.5|||t-test, 2 sided|||30 minutes post intervention||10.5|-5.5|0.526
70951135|NCT05239598|141403288|SUPERIORITY||Median Difference (Net)|0.04||||0.511|TWO_SIDED|95.0|-4.2|8.1|||Signed Rank|||Povidone-iodine: 5 minutes Post-Intervention||8.1|-4.2|0.511
70868533|NCT01709513|141223345|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-24.5|||<|0.0001|TWO_SIDED|95.0|-28.7|-20.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-20.4|-28.7|<0.0001
70951136|NCT05239598|141403288|SUPERIORITY||Median Difference (Net)|5.4||||0.408|TWO_SIDED|95.0|-10.7|18.6|||Signed Rank|||Povidone-iodine: 30 minutes post-intervention||18.6|-10.7|0.408
71142949|NCT04612725|141779493|SUPERIORITY||LS mean difference|1.47||||0.6591|TWO_SIDED|95.0|-5.09|8.02||Change from baseline in CU-Q2oL at Week 24= Treatment + baseline CU-Q2oL + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||8.02|-5.09|0.6591
71142950|NCT04612725|141779493|SUPERIORITY||LS mean difference|-3.04||||0.3624|TWO_SIDED|95.0|-9.62|3.54||Change from baseline in CU-Q2oL at Week 24= Treatment + baseline CU-Q2oL + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||3.54|-9.62|0.3624
71142951|NCT04612725|141779494|SUPERIORITY||LS mean difference|0.48||||0.7037|TWO_SIDED|95.0|-2.02|2.98||Change from baseline in DLQI at Week 12= Treatment + baseline DLQI + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||2.98|-2.02|0.7037
71142952|NCT04612725|141779494|SUPERIORITY||LS mean difference|-1.25||||0.332|TWO_SIDED|95.0|-3.78|1.29||Change from baseline in DLQI at Week 12= Treatment + baseline DLQI + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.29|-3.78|0.3320
71142953|NCT04612725|141779494|SUPERIORITY||LS mean difference|1.24||||0.359|TWO_SIDED|95.0|-1.42|3.9||Change from baseline in DLQI at Week 24= Treatment + baseline DLQI + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||3.90|-1.42|0.3590
71142954|NCT04612725|141779494|SUPERIORITY||LS mean difference|-0.88||||0.5175|TWO_SIDED|95.0|-3.56|1.8||Change from baseline in DLQI at Week 24= Treatment + baseline DLQI + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.80|-3.56|0.5175
71142955|NCT02354235|141779497|SUPERIORITY||Least Squares Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.15|-0.6|||ANCOVA|||||-0.60|-1.15|<0.001
70872242|NCT00407797|141229711|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0465|TWO_SIDED||||||t-test, 2 sided|||Week 21: Quantity of Sleep. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0465
70951137|NCT05239598|141403288|SUPERIORITY||Median Difference (Net)|-4.9||||0.907|TWO_SIDED|95.0|-15.2|17.5|||Signed Rank|||Povidone-iodine: 60 minutes post-intervention||17.5|-15.2|0.907
71142956|NCT02354235|141779498|SUPERIORITY||Least Squares Mean Difference|-38.8|STANDARD_ERROR_OF_MEAN|4.9|<|0.001|TWO_SIDED|95.0|-48.5|-29.2|||ANCOVA|||||-29.2|-48.5|<0.001
71142957|NCT02354235|141779499|SUPERIORITY||Least Squares Mean Difference|-2.33|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED|95.0|-3.2|-1.45|||ANCOVA|||||-1.45|-3.20|<0.001
71142958|NCT02354235|141779500|SUPERIORITY||Least Squares Mean Difference|-100.3|STANDARD_ERROR_OF_MEAN|11.1|<|0.001|TWO_SIDED|95.0|-122.2|-78.4|||ANCOVA|||||-78.4|-122.2|<0.001
71142959|NCT02354235|141779501|SUPERIORITY||Least Squares Mean Difference|-50.9|STANDARD_ERROR_OF_MEAN|7.1|<|0.001|TWO_SIDED|95.0|-64.9|-36.9|||ANCOVA|||||-36.9|-64.9|<0.001
71142960|NCT00718510|141779583|OTHER||||||<|0.05||||||General Psychopathology Subscale Score|ANOVA|F(1,11)=5.03||Null hypothesis is that there was no difference in change of PANSS between L-arginine and Placebo. A two-factor ANOVA was used across all subjects with the within-subject factor being the treatment phase (L-arginine first/Placebo second or Placebo first/L-arginine second) and the between-subject factor being the day of treatment (time). A sample size of 14 patients was needed to give 90% power to detect a 4 point difference on the PANSS. This included a drop-out rate of about 10%.||||<0.05
71142961|NCT00718510|141779584|OTHER|||||||0.46|||||||ANOVA|||Null hypothesis is that there was no difference in change of CGI ratings between L-arginine and Placebo. A two-factor ANOVA was used across all subjects with the within-subject factor being the treatment phase (L-arginine first/Placebo second or Placebo first/L-arginine second) and the between-subject factor being the day of treatment (time).||||0.46
70951138|NCT05239598|141403288|SUPERIORITY||Median Difference (Net)|-2.4||||0.008|TWO_SIDED|95.0|-6.5|-0.9|||Signed Rank|||Placebo: 5 minutes post intervention||-0.9|-6.5|0.008
70951139|NCT05239598|141403288|SUPERIORITY||Median Difference (Net)|-6.6||||0.08|TWO_SIDED|95.0|-10.1|-2.2|||Signed Rank|||Placebo: 30 minutes post-intervention||-2.2|-10.1|0.080
70951140|NCT05239598|141403288|SUPERIORITY||Median Difference (Net)|-8.6||||0.001|TWO_SIDED|95.0|-22.3|-3.9|||Signed Rank|||Placebo: 60 minutes post-intervention||-3.9|-22.3|0.001
70951141|NCT05239598|141403289|SUPERIORITY||Median Difference (Net)|3.1||||0.212|TWO_SIDED|95.0|-2.2|5.8|||Signed Rank|||Povidone-iodine 5 minutes post-intervention||5.8|-2.2|0.212
70951142|NCT05239598|141403289|SUPERIORITY||Median Difference (Net)|1.8||||0.334|TWO_SIDED|95.0|-2.3|6.9|||Signed Rank|||Povidone-iodine 30 minutes post-intervention||6.9|-2.3|0.334
70951143|NCT05239598|141403289|SUPERIORITY||Median Difference (Net)|1.5||||0.269|TWO_SIDED|95.0|-3.1|6.8|||Signed Rank|||Povidone-iodine 60 minutes post-intervention||6.8|-3.1|0.269
70951144|NCT05239598|141403289|SUPERIORITY||Median Difference (Net)|-4.1||||0.026|TWO_SIDED|95.0|-7.1|-0.7|||Signed Rank|||Placebo 5 minutes post-intervention||-0.7|-7.1|0.026
70951145|NCT05239598|141403289|SUPERIORITY||Median Difference (Net)|-0.7||||0.182|TWO_SIDED|95.0|-9.4|2.0|||Signed Rank|||Placebo 30 minutes post-intervention||2.0|-9.4|0.182
70951146|NCT05239598|141403289|SUPERIORITY||Median Difference (Net)|-3.6||||0.353|TWO_SIDED|95.0|-7.7|4.0|||Signed Rank|||Placebo 60 minutes post-intervention||4.0|-7.7|0.353
70951147|NCT01381575|141403304|NON_INFERIORITY|Non-inferiority with respect to seroconversion was demonstrated if, 1 month after the last dose, for both anti-HPV-16 and anti-HPV-18, the upper limit of the 95% Confidence Interval (CI) for the difference (Cervarix 2 Group minus Cervarix 1 Group) was below 5%.|Difference in SCR|0.0|||||TWO_SIDED|95.0|-1.08|0.78||||||Immune response to anti-HPV-16 in terms of seroconversion (SCR) rates: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule of 0,6 months in 9-14 year old females was non-inferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females, 1 month after the last dose of study vaccine, in initially seronegative subjects.||0.78|-1.08|
70951148|NCT01381575|141403304|NON_INFERIORITY|Non-inferiority with respect to seroconversion was demonstrated if, 1 month after the last dose, for both anti-HPV-16 and anti-HPV-18, the upper limit of the 95% Confidence Interval (CI) for the difference (Cervarix 2 Group minus Cervarix 1 Group) was below 5%.|Difference in SCR|0.0|||||TWO_SIDED|95.0|-1.0|0.77||||||Immune response to anti-HPV-18 in terms of seroconversion (SCR) rates: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule of 0,6 months in 9-14 year old females was non-inferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females, 1 month after the last dose of study vaccine, in initially seronegative subjects.||0.77|-1.00|
70951149|NCT01381575|141403305|NON_INFERIORITY|Non-inferiority with respect to Geometric Mean Concentrations (GMCs) was demonstrated if, 1 month after the last dose, for both anti-HPV-16 and anti-HPV-18, the upper limit of 95% CI for the GMT ratio (Cervarix 2 Group divided by Cervarix 1 Group) was below 2.|Geometric mean ratio|1.09|||||TWO_SIDED|95.0|0.97|1.22||||||Immune response to anti-HPV-16 in terms of Geometric Mean Concentrations (GMCs): To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months in 9-14 year old females was non-inferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females, 1 month after the last dose of study vaccine, in initially seronegative subjects.||1.22|0.97|
70951150|NCT01381575|141403305|NON_INFERIORITY|Non-inferiority with respect to Geometric Mean Concentrations (GMCs) was demonstrated if, 1 month after the last dose, for both anti-HPV-16 and anti-HPV-18, the upper limit of 95% CI for the GMT ratio (Cervarix 2 Group divided by Cervarix 1 Group) was below 2.|Geometric mean ratio|0.85|||||TWO_SIDED|95.0|0.76|0.95||||||Immune response to anti-HPV-18 in terms of Geometric Mean Concentrations (GMCs): To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months in 9-14 year old females was non-inferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females, 1 month after the last dose of study vaccine, in initially seronegative subjects.||0.95|0.76|
70951151|NCT01443403|141403342|SUPERIORITY_OR_OTHER||LS Mean Difference|2.22|STANDARD_ERROR_OF_MEAN|0.605||0.0003|TWO_SIDED|95.0|1.02|3.41|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment group as a term and baseline value as a covariate.||||3.41|1.02|0.0003
70951152|NCT01443403|141403342|SUPERIORITY_OR_OTHER||LS Mean Difference|1.95|STANDARD_ERROR_OF_MEAN|0.604||0.0014|TWO_SIDED|95.0|0.76|3.14|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||3.14|0.76|0.0014
70951153|NCT01443403|141403342|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56|STANDARD_ERROR_OF_MEAN|0.599||0.3504|TWO_SIDED|95.0|-0.62|1.74|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.74|-0.62|0.3504
70951154|NCT01443403|141403344|SUPERIORITY_OR_OTHER||LS Mean Difference|1.93|STANDARD_ERROR_OF_MEAN|0.568||0.0008|TWO_SIDED|95.0|0.81|3.05|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||3.05|0.81|0.0008
70951155|NCT01443403|141403344|SUPERIORITY_OR_OTHER||LS Mean Difference|1.91|STANDARD_ERROR_OF_MEAN|0.569||0.0009|TWO_SIDED|95.0|0.79|3.04|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||3.04|0.79|0.0009
70951156|NCT01443403|141403344|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.558||0.2572|TWO_SIDED|95.0|-0.47|1.73|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.73|-0.47|0.2572
70872243|NCT00407797|141229711|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0316|TWO_SIDED||||||t-test, 2 sided|||LOCF: Quantity of Sleep. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0316
70951157|NCT01443403|141403346|SUPERIORITY_OR_OTHER||LS Mean Difference|1.33|STANDARD_ERROR_OF_MEAN|0.484||0.0065|TWO_SIDED|95.0|0.38|2.28|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.28|0.38|0.0065
70951158|NCT01443403|141403346|SUPERIORITY_OR_OTHER||LS Mean Difference|1.64|STANDARD_ERROR_OF_MEAN|0.482||0.0008|TWO_SIDED|95.0|0.69|2.58|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.58|0.69|0.0008
70951159|NCT01443403|141403346|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.476||0.2921|TWO_SIDED|95.0|-0.43|1.44|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.44|-0.43|0.2921
70951160|NCT01443403|141403348|SUPERIORITY_OR_OTHER||LS Mean Difference|1.44|STANDARD_ERROR_OF_MEAN|0.495||0.0039|TWO_SIDED|95.0|0.47|2.42|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.42|0.47|0.0039
70951161|NCT01443403|141403348|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.492||0.0007|TWO_SIDED|95.0|0.73|2.67|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.67|0.73|0.0007
70951162|NCT01443403|141403348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.488||0.3077|TWO_SIDED|95.0|-0.46|1.46|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.46|-0.46|0.3077
70868534|NCT01709513|141223346|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.7|||<|0.0001|TWO_SIDED|95.0|-29.9|-21.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-21.5|-29.9|<0.0001
70951163|NCT01443403|141403350|SUPERIORITY_OR_OTHER||Difference|27.3||||0.003|TWO_SIDED|95.0|10.0|44.6|||Chi-squared|||||44.6|10.0|0.0030
70951164|NCT01443403|141403350|SUPERIORITY_OR_OTHER||Difference|31.8||||0.0005|TWO_SIDED|95.0|15.0|48.7|||Chi-squared|||||48.7|15.0|0.0005
70951165|NCT01443403|141403350|SUPERIORITY_OR_OTHER||Difference|13.1||||0.1461|TWO_SIDED|95.0|-4.4|30.6|||Chi-squared|||||30.6|-4.4|0.1461
70951166|NCT01443403|141403352|SUPERIORITY_OR_OTHER||Difference|24.3||||0.005|TWO_SIDED|95.0|7.8|40.8|||Chi-squared|||||40.8|7.8|0.0050
70868535|NCT01709513|141223347|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-21.1|||<|0.0001|TWO_SIDED|95.0|-24.5|-17.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-17.7|-24.5|<0.0001
70951167|NCT01443403|141403352|SUPERIORITY_OR_OTHER||Difference|24.5||||0.0045|TWO_SIDED|95.0|8.1|40.8|||Chi-squared|||||40.8|8.1|0.0045
70951168|NCT01443403|141403352|SUPERIORITY_OR_OTHER||Difference|8.2||||0.2984|TWO_SIDED|95.0|-7.2|23.6|||Chi-squared|||||23.6|-7.2|0.2984
70951169|NCT01443403|141403354|SUPERIORITY_OR_OTHER||LS Mean Difference|1.54|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|0.9|2.17|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.17|0.90|<0.0001
70951170|NCT01443403|141403354|SUPERIORITY_OR_OTHER||LS Mean Difference|1.22|STANDARD_ERROR_OF_MEAN|0.32||0.0002|TWO_SIDED|95.0|0.59|1.85|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.85|0.59|0.0002
70951171|NCT01443403|141403354|SUPERIORITY_OR_OTHER||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.317||0.0698|TWO_SIDED|95.0|-0.05|1.2|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.20|-0.05|0.0698
70951172|NCT01443403|141403356|SUPERIORITY_OR_OTHER||LS Mean Difference|1.19|STANDARD_ERROR_OF_MEAN|0.307||0.0001|TWO_SIDED|95.0|0.58|1.79|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.79|0.58|0.0001
70951173|NCT01443403|141403356|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.305||0.0004|TWO_SIDED|95.0|0.49|1.7|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.70|0.49|0.0004
71142962|NCT00718510|141779585|OTHER|||||||0.55|||||||ANOVA|||Null hypothesis is that there was no difference in change of CDSS ratings between L-arginine and Placebo. A two-factor ANOVA was used across all subjects with the within-subject factor being the treatment phase (L-arginine first/Placebo second or Placebo first/L-arginine second) and the between-subject factor being the day of treatment (time).||||0.55
70872244|NCT00407797|141229712|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2187|TWO_SIDED|95.0|||||t-test, 2 sided|||Week 21; change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.2187
70951174|NCT01443403|141403356|SUPERIORITY_OR_OTHER||LS Mean Difference|0.42|STANDARD_ERROR_OF_MEAN|0.302||0.1648|TWO_SIDED|95.0|-0.17|1.02|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.02|-0.17|0.1648
70951175|NCT01443403|141403358|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0004
70951176|NCT01443403|141403358|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
70951177|NCT01443403|141403358|SUPERIORITY_OR_OTHER|||||||0.0118||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0118
70951178|NCT01443403|141403359|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
70951179|NCT01443403|141403359|SUPERIORITY_OR_OTHER|||||||0.0011||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0011
70951180|NCT01443403|141403359|SUPERIORITY_OR_OTHER|||||||0.0079||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0079
70951181|NCT01443403|141403362|SUPERIORITY_OR_OTHER||LS Mean Difference|1.33|STANDARD_ERROR_OF_MEAN|0.358||0.0003|TWO_SIDED|95.0|0.62|2.03|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.03|0.62|0.0003
70951182|NCT01443403|141403362|SUPERIORITY_OR_OTHER||LS Mean Difference|1.51|STANDARD_ERROR_OF_MEAN|0.359|<|0.0001|TWO_SIDED|95.0|0.8|2.22|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.22|0.80|<0.0001
70951183|NCT01443403|141403362|SUPERIORITY_OR_OTHER||LS Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.352||0.1211|TWO_SIDED|95.0|-0.15|1.24|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.24|-0.15|0.1211
70951184|NCT01443403|141403364|SUPERIORITY_OR_OTHER||LS Mean Difference|2.36|STANDARD_ERROR_OF_MEAN|0.551|<|0.0001|TWO_SIDED|95.0|1.28|3.45|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||3.45|1.28|<0.0001
70951185|NCT01443403|141403364|SUPERIORITY_OR_OTHER||LS Mean Difference|2.07|STANDARD_ERROR_OF_MEAN|0.549||0.0002|TWO_SIDED|95.0|0.99|3.15|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||3.15|0.99|0.0002
70868536|NCT01709513|141223348|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|19.5|||<|0.0001|TWO_SIDED|95.0|6.9|55.2||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||55.2|6.9|<0.0001
70868537|NCT01709513|141223349|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|24.9|||<|0.0001|TWO_SIDED|95.0|8.6|71.9||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||71.9|8.6|<0.0001
70868538|NCT01709513|141223350|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|71.5|||<|0.0001|TWO_SIDED|95.0|11.1|3022.1||Threshold for significance ≤ 0.05.|Regression, Exact Conditional Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a last observation carried forward (LOCF) approach followed by Exact conditional logistic regression model.||3022.1|11.1|<0.0001
71142963|NCT00844376|141779594|SUPERIORITY_OR_OTHER_LEGACY||ratio of adjusted geometric means|95.77||||||90.0|85.82|106.88|||Mixed Models Analysis|The mixed effects model was implemented using SAS Proc Mixed, with REML estimation method and Kenward-Roger degrees of freedom algorithm.|Natural log transformed AUC48 was analyzed using a mixed effect model with sequence, period and treatment as a fixed effect and subject within sequence as a random effect.|Ratio of adjusted means (test/reference), and 90% CI for ratio--for AUC48; restricted (residual) maximum likelihood (REML) method of estimation.||106.88|85.82|
71142964|NCT00844376|141779595|SUPERIORITY_OR_OTHER_LEGACY||ratio of adjusted geometric means|95.04||||||90.0|84.99|106.27|||Mixed Models Analysis|The mixed effects model was implemented using SAS Proc Mixed, with REML estimation method and Kenward-Roger degrees of freedom algorithm.|Natural log transformed AUCinf was analyzed using a mixed effect model with sequence, period and treatment as a fixed effect and subject within sequence as a random effect.|Ratio of adjusted means (test/reference), and 90% CI for ratio--for AUCinf||106.27|84.99|
71142965|NCT00844376|141779596|SUPERIORITY_OR_OTHER_LEGACY||ratio of adjusted geometric means|94.86||||||90.0|83.86|107.29|||Mixed Models Analysis|The mixed effects model was implemented using SAS Proc Mixed, with REML estimation method and Kenward-Roger degrees of freedom algorithm.|Natural log transformed AUClast was analyzed using a mixed effect model with sequence, period and treatment as a fixed effect and subject within sequence as a random effect.|Ratio of adjusted means (test/reference), and 90% CI for ratio--for AUClast||107.29|83.86|
71142966|NCT00844376|141779597|SUPERIORITY_OR_OTHER_LEGACY||ratio of adjusted geometric means|117.9||||||90.0|98.22|141.53|||Mixed Models Analysis|The mixed effects model was implemented using SAS Proc Mixed, with REML estimation method and Kenward-Roger degrees of freedom algorithm.|Natural log transformed Cmax was analyzed using a mixed effect model with sequence, period and treatment as a fixed effect and subject within sequence as a random effect.|Ratio of adjusted means (test/reference), and 90% CI for ratio--for Cmax||141.53|98.22|
71142967|NCT00549640|141779603|SUPERIORITY_OR_OTHER|||||||0.973||95.0|||||Fisher Exact|1-tailed||||||0.973
71142968|NCT00549640|141779604|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Fisher Exact|1 tailed test||||||0.500
71142969|NCT00549640|141779605|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||t-test, 2 sided|For each subject, the average daily withdrawal score for the 14 days following target quit date was calculated and expressed as a change from baseline||||||0.65
71142970|NCT00549640|141779605|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Mixed Models Analysis|analysis performed using daily scores||||||0.79
71142971|NCT00660192|141779606|SUPERIORITY_OR_OTHER|||||||0.0347|TWO_SIDED||||||t-test, 2 sided|||||||0.0347
71142972|NCT00660192|141779607|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Fisher Exact|||||||0.0300
71142973|NCT02734693|141779608|SUPERIORITY||Mean Difference (Final Values)|-5.18|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-7.565|-2.802|||ANCOVA|||Least squares means, SEs, effect sizes, 95% CIs, and p-values were generated using an ANCOVA model, with treatment (dasotraline/placebo), mean SKAMP-CS at baseline, and site as fixed effects. The dasotraline 6 mg/day treatment arm was discontinued in Version 3.00 of the protocol.||-2.802|-7.565|<0.001
70951186|NCT01443403|141403364|SUPERIORITY_OR_OTHER||LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.542||0.2022|TWO_SIDED|95.0|-0.37|1.76|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.76|-0.37|0.2022
70951187|NCT01443403|141403367|SUPERIORITY_OR_OTHER|||||||0.0272||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0272
70951188|NCT01443403|141403367|SUPERIORITY_OR_OTHER|||||||0.1355||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1355
70951189|NCT01443403|141403367|SUPERIORITY_OR_OTHER|||||||0.3689||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3689
70951190|NCT01443403|141403369|SUPERIORITY_OR_OTHER|||||||0.2126||95.0|||||Welch's t-test|||||||0.2126
70951191|NCT01443403|141403369|SUPERIORITY_OR_OTHER|||||||0.2799||95.0|||||Welch's t-test|||||||0.2799
70951192|NCT01443403|141403369|SUPERIORITY_OR_OTHER|||||||0.6466||95.0|||||Welch's t-test|||||||0.6466
70951193|NCT01443403|141403371|SUPERIORITY_OR_OTHER|||||||0.9826||95.0|||||Welch's t-test|||||||0.9826
70951194|NCT01443403|141403371|SUPERIORITY_OR_OTHER|||||||0.5188||95.0|||||Welch's t-test|||||||0.5188
70951195|NCT01443403|141403371|SUPERIORITY_OR_OTHER|||||||0.5029||95.0|||||Welch's t-test|||||||0.5029
70951196|NCT01681277|141403380|SUPERIORITY_OR_OTHER||Slope|1.2208|STANDARD_ERROR_OF_MEAN|0.1386|||TWO_SIDED|95.0|0.9354|1.5062|||||"Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1.~PK endpoints on the log-transformed scale. Standard Error of the mean is actually the Standard Error of the slope"|This was non confirmatory testing (Single dose). Dose proportionality of BI 113608 for Cmax,ss was analysed.||1.5062|0.9354|
70951197|NCT01681277|141403382|SUPERIORITY_OR_OTHER||Slope|1.3135|STANDARD_ERROR_OF_MEAN|0.1206|||TWO_SIDED|95.0|1.0652|1.5618|||||"Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1.~PK endpoints on the log-transformed scale. Standard Error of the mean is actually the Standard Error of the slope"|This was non confirmatory testing (Single dose). Dose proportionality of BI 113608 for AUCt,ss was analysed.||1.5618|1.0652|
70951198|NCT00474526|141403389|SUPERIORITY_OR_OTHER||Ratio of GMTs|4.53|||||TWO_SIDED|95.0|3.04|6.74|||ANOVA||A (Post-vaccination GMT; group ratio US1A:US2)|Using the MenACWY GMTs, immunogenicity of the fourth dose at 1 month after the 12-month vaccination in those subjects receiving MenACWY at 2, 4, and 6 months was considered superior to the immune response of a single dose given at 12-months of age if the lower limit of the two-sided 95% CI of the ratio of the two GMTs was \>= 2.0.||6.74|3.04|
70951199|NCT00474526|141403389|SUPERIORITY_OR_OTHER||Ratio of GMTs|6.39|||||TWO_SIDED|95.0|4.16|9.79|||ANOVA||C (Post-vaccination GMT; group ratio US1A:US2)|Using the MenACWY GMTs, immunogenicity of the fourth dose at 1 month after the 12-month vaccination in those subjects receiving MenACWY at 2, 4, and 6 months was considered superior to the immune response of a single dose given at 12-months of age if the lower limit of the two-sided 95% CI of the ratio of the two GMTs was \>= 2.0.||9.79|4.16|
70951200|NCT00474526|141403389|SUPERIORITY_OR_OTHER||Ratio of GMTs|37.0|||||TWO_SIDED|95.0|24.0|58.0|||ANOVA||W (Post-vaccination GMT; group ratio US1A:US2)|Using the MenACWY GMTs, immunogenicity of the fourth dose at 1 month after the 12-month vaccination in those subjects receiving MenACWY at 2, 4, and 6 months was considered superior to the immune response of a single dose given at 12-months of age if the lower limit of the two-sided 95% CI of the ratio of the two GMTs was \>= 2.0.||58|24|
70951201|NCT00474526|141403389|SUPERIORITY_OR_OTHER||Ratio of GMTs|38.0|||||TWO_SIDED|95.0|24.0|60.0|||ANOVA||Y (Post-vaccination GMT; group ratio US1A:US2)|"Using the MenACWY GMTs, immunogenicity of the fourth dose at 1 month after the 12-month vaccination in those subjects receiving MenACWY at 2, 4, and 6 months was considered superior to the immune response of a single dose given at 12-months of age if the lower limit of the two-sided 95% CI of the ratio of the two GMTs was \>= 2.0.~Ratio of GMTs"||60|24|
70951202|NCT00474526|141403398|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the ratio of GMTs between the 2 dose and the 3 dose schedule (GMTLA1/GMTLA3) must be \> 0.5.|Ratio of GMT|0.73|||||TWO_SIDED|95.0|0.55|0.95|||ANOVA|||Serogroup A (Post-vaccination GMT; group ratio LA1:LA3)||0.95|0.55|
70951203|NCT00474526|141403398|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the ratio of GMTs between the 2 dose and the 3 dose schedule (GMTLA1/GMTLA3) must be \> 0.5.|Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.81|1.31|||ANOVA|||Serogroup C (Post-vaccination GMT; group ratio LA1:LA3)||1.31|0.81|
70951204|NCT00474526|141403398|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the ratio of GMTs between the 2 dose and the 3 dose schedule (GMTLA1/GMTLA3) must be \> 0.5.|Ratio of GMTs|1.42|||||TWO_SIDED|95.0|1.18|1.72|||ANOVA|||Serogroup W (Post-vaccination GMT; group ratio LA1:LA3)||1.72|1.18|
70951205|NCT00474526|141403398|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the ratio of GMTs between the 2 dose and the 3 dose schedule (GMTLA1/GMTLA3) must be \> 0.5.|Ratio of GMTs|1.27|||||TWO_SIDED|95.0|1.02|1.58|||ANOVA|||Serogroup Y (Post-vaccination GMT; group ratio LA1:LA3)||1.58|1.02|
70951206|NCT00474526|141403401|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA ≥ 1:8 and ≥1:4 between the 2 dose and the 3 dose schedule (PLA1 - PLA3) must be greater than -10%.|Percentage (hSBA titers >=8) difference|-15.0|||||TWO_SIDED|95.0|-21.2|-8.5|||ANOVA|||Serogroup A (post-vaccination percentage of subjects with hSBA titer \>=8, group difference (PLA1 - PLA3))||-8.5|-21.2|
70951207|NCT00474526|141403401|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA ≥ 1:8 and ≥1:4 between the 2 dose and the 3 dose schedule (PLA1 - PLA3) must be greater than -10%.|Percentage (hSBA titers >=8) difference|-3.0|||||TWO_SIDED|95.0|-7.0|0.3|||ANOVA|||Serogroup C (post-vaccination percentage of subjects with hSBA titer \>=8, group difference (PLA1 - PLA3))||0.3|-7|
70951208|NCT00474526|141403401|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA ≥ 1:8 and ≥1:4 between the 2 dose and the 3 dose schedule (PLA1 - PLA3) must be greater than -10%.|Percentage (hSBA titers >=8) difference|1.0|||||TWO_SIDED|95.0|-1.3|3.1|||ANOVA|||Serogroup W (post-vaccination percentage of subjects with hSBA titer \>=8, group difference (PLA1 - PLA3))||3.1|-1.3|
70951209|NCT00474526|141403401|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA ≥ 1:8 and ≥1:4 between the 2 dose and the 3 dose schedule (PLA1 - PLA3) must be greater than -10%.|Percentage (hSBA titers >=8) difference|-1.0|||||TWO_SIDED|95.0|-4.0|1.7|||ANOVA|||Serogroup Y (post-vaccination percentage of subjects with hSBA titer \>=8, group difference (PLA1 - PLA3))||1.7|-4|
70951210|NCT00474526|141403403|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.87|||||TWO_SIDED|95.0|0.74|1.04|||ANOVA|||Diphtheria (Post-vaccination GMT; group ratio US1:US2)||1.04|0.74|
70951211|NCT00474526|141403403|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.08|||||TWO_SIDED|95.0|0.92|1.28|||ANOVA|||Tetanus (Post-vaccination GMT; group ratio US1:US2)||1.28|0.92|
70951212|NCT00474526|141403403|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.79|1.26|||ANOVA|||PT (Post-vaccination GMT; group ratio US1:US2)||1.26|0.79|
70872245|NCT00407797|141229712|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1905|TWO_SIDED|95.0|||||t-test, 2 sided|||LOCF; change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.1905
70951213|NCT00474526|141403403|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.85|1.25||||||FHA (Post-vaccination GMT; group ratio US1:US2)||1.25|0.85|
70868539|NCT01709513|141223351|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|109.8|||<|0.0001|TWO_SIDED|95.0|16.5|4759.3||Threshold for significance ≤ 0.05.|Regression, Exact Conditional Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a LOCF approach followed by Exact conditional logistic regression model.||4759.3|16.5|<0.0001
71142974|NCT02734693|141779611|SUPERIORITY||Mean Difference (Final Values)|23.67|STANDARD_ERROR_OF_MEAN|7.395||0.002|TWO_SIDED|95.0|8.987|38.346|||ANCOVA|||Least squares means, SEs, effect sizes, 95% CIs, and p-values were generated using an ANCOVA model, with treatment (dasotraline/placebo), PERMP at baseline, and site as fixed effects. The dasotraline 6 mg/day treatment arm was discontinued in Version 3.00 of the protocol||38.346|8.987|0.002
71142975|NCT02734693|141779611|SUPERIORITY||Mean Difference (Net)|24.05|STANDARD_ERROR_OF_MEAN|7.389||0.002|TWO_SIDED|95.0|9.381|38.714|||ANCOVA|||Least squares means, SEs, effect sizes, 95% CIs, and p-values were generated using an ANCOVA model, with treatment (dasotraline/placebo), PERMP at baseline, and site as fixed effects. The dasotraline 6 mg/day treatment arm was discontinued in Version 3.00 of the protocol||38.714|9.381|0.002
71142976|NCT01069484|141779628|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation was based on the study by Mørkved and Bø (1997), showing 67% prevalence reduction of UI in the PFMT group and 34% reduction in the control group. Assuming a similar effect, two-sided significance of \<0.05, and a power of 0.90, required a total of 62 women. Stratified analysis on major levator ani (LA) muscle defects was planned, but the effect of PFMT in women with such defects was unknown. The statistical advice was to aim for 80 women with- and 80 women without such defects.|Risk Ratio (RR)|0.89||||0.57|TWO_SIDED|95.0|0.6|1.32||P-values \< 0.05 were considered significant.|Mantel Haenszel||"Pelvic floor muscle training arm represents the numerator for relative risk and usual care arm represents the denominator for relative risk"|"Intention to treat was the principal analysis. Missing values for categorical data (self-reported UI) the approach of last observation carried forward was used."||1.32|0.60|0.57
71142977|NCT01069484|141779629|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84||||0.51|TWO_SIDED|95.0|0.49|1.42||P-values \< 0.05 were considered significant.|Mantel Haenszel||"Pelvic floor muscle training arm represents the numerator for relative risk and usual care arm represents the denominator for relative risk"|"Intention to treat was the principal analysis. Missing values for categorical data (self-reported UI) the approach of last observation carried forward was used."||1.42|0.49|0.51
71142978|NCT00771914|141779660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0|TWO_SIDED|95.0||||The analyses were not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The Wilcoxon Signed-Rank Test was used to determine significant differences between the closure time effect (clotting)in seconds from baseline compared to four hours after placebo.||||0.00
71142979|NCT00771914|141779660|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|12.0||||0.31|TWO_SIDED|95.0||||The analyses were not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The Wilcoxon Signed-Rank Test was used to determine significant differences between the closure time effect (clotting)in seconds from Aspirin compared to Placebo.||||0.31
71142980|NCT00771914|141779660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.0||||0.49|TWO_SIDED|95.0||||The analyses were not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The Wilcoxon Signed-Rank Test was used to determine significant differences between the closure time effect (clotting)in seconds from Lovaza compared to Placebo.||||0.49
71142981|NCT00771914|141779660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.0||||0.03|TWO_SIDED|95.0||||The analyses were not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The Wilcoxon Signed-Rank Test was used to determine significant differences between the closure time effect (clotting)in seconds from both Aspirin and Lovaza compared to Placebo.||||0.03
71142982|NCT03111875|141779680|SUPERIORITY|common effect|Risk Ratio (RR)|1.04||||0.69|TWO_SIDED|95.6|0.87|1.24|||Mixed Models Analysis|||||1.24|0.87|0.69
71142983|NCT03111875|141779680|SUPERIORITY|average relative effect|Risk Ratio (RR)|0.68||||0.1|TWO_SIDED|95.6|0.43|1.08|||Mixed Models Analysis|||||1.08|0.43|0.10
71142984|NCT03111875|141779681|SUPERIORITY||Risk Ratio (RR)|1.13||||0.25|TWO_SIDED|98.75|0.87|1.47|||log-binomial models|The relative risk was estimated using a GEE model to adjust for within-patient correlation across components and log link (to estimate relative risk).||||1.47|0.87|0.25
71142985|NCT03111875|141779682|SUPERIORITY||Risk Ratio (RR)|1.07||||0.41|TWO_SIDED|98.75|0.87|1.33|||log-binomial models|The relative risk was estimated using a GEE model to adjust for within-patient correlation across components and log link (to estimate relative risk)||||1.33|0.87|0.41
71142986|NCT00960375|141779720|SUPERIORITY_OR_OTHER|||||||0.489|TWO_SIDED||||||ANOVA|||Smoking reduction outcomes were examined in the randomized sample using data from baseline and post-treatment assessments. The variable examined was self-reported number of cigarettes smoked per day during the last 7 days. This variable was skewed so a natural log transformation was applied before linear mixed model analysis.||||0.489
71142987|NCT00960375|141779721|SUPERIORITY_OR_OTHER|||||||0.685|TWO_SIDED||||||ANOVA|||This outcome was examined in the randomized sample. Abstinence was defined as self-reported no smoking in the last 7 days + expired CO ≤ 10 PPM. To assess difference in change between conditions, we tested the significance of the condition-by-time interaction using repeated measured mixed models with a random participant effect. Time was binary: post-treatment versus baseline. We used a logistic model for binary outcomes.||||0.685
71142988|NCT00591006|141779722|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||||||<0.01
71142989|NCT00591006|141779722|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Mixed Models Analysis|||||||.12
71142990|NCT00591006|141779722|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Mixed Models Analysis|||||||.15
71142991|NCT00591006|141779722|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Mixed Models Analysis|||||||.10
71142992|NCT00591006|141779723|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Mixed Models Analysis|||||||.08
71142993|NCT00591006|141779723|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||||||<.01
71142994|NCT00591006|141779723|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||||||<.01
71142995|NCT00591006|141779723|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|||||||.02
70951214|NCT00474526|141403403|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.04|||||TWO_SIDED|95.0|0.83|1.32|||ANOVA|||Pertactin (Post-vaccination GMT; group ratio US1:US2||1.32|0.83|
70951215|NCT00474526|141403403|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.96|||||TWO_SIDED|95.0|0.75|1.23|||ANOVA|||Polio Type 1 (Post-vaccination GMT; group ratio US1:US2)||1.23|0.75|
70951216|NCT00474526|141403403|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.2|||||TWO_SIDED|95.0|0.93|1.55|||ANOVA|||Polio Type 2 (Post-vaccination GMT; group ratio US1:US2)||1.55|0.93|
70951217|NCT00474526|141403403|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.15|||||TWO_SIDED|95.0|0.85|1.56|||ANOVA|||Polio Type 3 (Post-vaccination GMT; group ratio US1:US2)||1.56|0.85|
70951218|NCT00474526|141403403|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.88||||||95.0|0.65|1.2|||ANOVA|||Hepatitis B (Post-vaccination GMT; group ratio US1:US2)||1.2|0.65|
70951219|NCT00474526|141403403|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.31|||||TWO_SIDED|95.0|0.97|1.77|||ANOVA|||HIb (Post-vaccination GMT; group ratio US1:US2)||1.77|0.97|
70951220|NCT00474526|141403403|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.84|||||TWO_SIDED|95.0|0.7|1.0|||ANOVA|||PnC 4 (Post-vaccination GMT; group ratio US1:US2)||1|0.7|
70951221|NCT00474526|141403403|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.76|||||TWO_SIDED|95.0|0.56|1.03|||ANOVA|||PnC 6B (Post-vaccination GMT; group ratio US1:US2)||1.03|0.56|
70951222|NCT00474526|141403403|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.85||||||95.0|0.7|1.04|||ANOVA|||PnC 9V (Post-vaccination GMT; group ratio US1:US2)||1.04|0.7|
70951223|NCT00474526|141403403|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.84|1.26|||ANOVA|||PnC 14 (Post-vaccination GMT; group ratio US1:US2)||1.26|0.84|
70951224|NCT00474526|141403403|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.77|||||TWO_SIDED|95.0|0.64|0.93|||ANOVA|||PnC 18C (Post-vaccination GMT; group ratio US1:US2)||0.93|0.64|
70951225|NCT00474526|141403403|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.82|||||TWO_SIDED|95.0|0.69|0.97|||ANOVA|||PnC 19F (Post-vaccination GMT; group ratio US1:US2)||0.97|0.69|
71142996|NCT00591006|141779724|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Mixed Models Analysis|||||||.08
71142997|NCT00591006|141779724|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||||||<.01
71142998|NCT00591006|141779724|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Mixed Models Analysis|||||||.11
71142999|NCT00591006|141779724|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Mixed Models Analysis|||||||.06
70951226|NCT00474526|141403403|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.79|||||TWO_SIDED|95.0|0.62|1.02|||ANOVA|||PnC 23F (Post-vaccination GMT; group ratio US1:US2)||1.02|0.62|
71143000|NCT03174184|141779737|EQUIVALENCE|Equivalence tests will be conducted to examine whether the EBA0-14CFU of Arm A is different from the EBA0-14CFU of Arm B. A similar comparison will be done comparing Arm C to Arm D, Arm A to Arm C, Arm D to Arm E, Arm D to Arm F, and Arm E to Arm F.|||||<|0.001|||||||Regression, Linear|||||||<0.001
71143001|NCT00525512|141779755|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.13||||0.1062||95.0|0.97|1.32||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.32|0.97|0.1062
71143002|NCT00525512|141779756|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.12||||0.008||95.0|1.03|1.23||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.23|1.03|0.008
71143003|NCT00525512|141779757|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.1||||0.0597||95.0|1.0|1.21||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.21|1.00|0.0597
71143004|NCT00525512|141779758|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.15||||0.0131||95.0|1.03|1.29||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.29|1.03|0.0131
70872246|NCT00407797|141229713|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Anxiety: Week 21. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||<.0001
70951227|NCT00474526|141403404|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0|||ANOVA|||Diphtheria (Seroconversion percentage difference (PUS1 - PUS2))||3|-3|
70951228|NCT00474526|141403404|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|4.0|||ANOVA|||Tetanus (Seroconversion percentage difference (PUS1 - PUS2))||4|-2|
70951229|NCT00474526|141403404|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|2.0|||||TWO_SIDED|95.0|-7.0|12.0|||ANOVA|||PT (Seroconversion percentage difference (PUS1 - PUS2))||12|-7|
70951230|NCT00474526|141403404|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|6.0|||||TWO_SIDED|95.0|-4.0|17.0|||ANOVA|||FHA(Seroconversion percentage difference (PUS1 - PUS2))||17|-4|
70951231|NCT00474526|141403404|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-12.0|10.0|||ANOVA|||Pertactin (Seroconversion percentage difference (PUS1 - PUS2))||10|-12|
70951232|NCT00474526|141403404|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.0|3.0|||ANOVA|||Polio Type 1 (Seroconversion percentage difference (PUS1 - PUS2))||3|-3|
70951233|NCT00474526|141403404|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|4.0|||ANOVA|||Polio Type 2 (Seroconversion percentage difference (PUS1 - PUS2))||4|-2|
70951234|NCT00474526|141403404|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.0|3.0|||ANOVA|||Polio Type 3 (Seroconversion percentage difference (PUS1 - PUS2))||3|-3|
70951235|NCT00474526|141403404|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-4.0|3.0|||ANOVA|||Hepatitis B(Seroconversion percentage difference (PUS1 - PUS2))||3|-4|
71143005|NCT00525512|141779759|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.18||||0.0041||95.0|1.05|1.32||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.32|1.05|0.0041
71143006|NCT00525512|141779760|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.11||||0.0945||95.0|0.98|1.26||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.26|0.98|0.0945
70951236|NCT00474526|141403404|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.0|3.0|||ANOVA|||Hib (≥ 0.15 μg/mL)(Seroconversion percentage difference (PUS1 - PUS2))||3|-3|
70951237|NCT00474526|141403404|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|5.0|||||TWO_SIDED|95.0|-3.0|14.0|||ANOVA|||Hib (≥1.0 μg/mL)(Seroconversion percentage difference (PUS1 - PUS2))||14|-3|
71143007|NCT00525512|141779761|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.12||||0.0899||95.0|0.98|1.28||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.28|0.98|0.0899
70868540|NCT01709513|141223352|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-18.7|||<|0.0001|TWO_SIDED|95.0|-25.5|-11.8||Threshold for significance ≤ 0.05.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-11.8|-25.5|<0.0001
70951238|NCT00474526|141403404|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-5.0|2.0|||ANOVA|||PnC 4(Seroconversion percentage difference (PUS1 - PUS2))||2|-5|
70951239|NCT00474526|141403404|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|(Seroconversion percentage difference (P|-8.0|||||TWO_SIDED|95.0|-14.0|-1.0|||ANOVA|||PnC 6B(Seroconversion percentage difference (PUS1 - PUS2))||-1|-14|
70951240|NCT00474526|141403404|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-4.0|5.0|||ANOVA|||PnC 9V (Seroconversion percentage difference (PUS1 - PUS2))||5|-4|
70951241|NCT00474526|141403404|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Diphtheria (Seroconversion percentage di|1.0|||||TWO_SIDED|95.0|-1.0|5.0|||ANOVA|||PnC 14 (Seroconversion percentage difference (PUS1 - PUS2))||5|-1|
71143008|NCT00525512|141779762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.116|||<|0.0001||95.0|0.073|0.16||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.160|0.073|<0.0001
71143009|NCT00525512|141779763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082||||0.0005||95.0|0.036|0.128||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.128|0.036|0.0005
70951242|NCT00474526|141403404|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-3.0|||||TWO_SIDED|95.0|-6.0|1.0|||ANOVA|||PnC 18C (Seroconversion percentage difference (PUS1 - PUS2))||1|-6|
70951243|NCT00474526|141403404|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|(Seroconversion percentage difference (P|-1.0|||||TWO_SIDED|95.0|-4.0|3.0|||ANOVA|||PnC 19F (Seroconversion percentage difference (PUS1 - PUS2))||3|-4|
70951244|NCT00474526|141403404|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-8.0|5.0|||ANOVA|||PnC 23F (Seroconversion percentage difference (PUS1 - PUS2))||5|-8|
70951245|NCT00474526|141403405|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.16|||||TWO_SIDED|95.0|0.96|1.4|||ANOVA|||Diphtheria (Post-vaccination GMC; group ratio LA1:LA2)||1.4|0.96|
70951246|NCT00474526|141403405|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.1|||||TWO_SIDED|95.0|0.96|1.27|||ANOVA|||Tetanus (Post-vaccination GMC; group ratio LA1:LA2)||1.27|0.96|
70951247|NCT00474526|141403405|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.04|||||TWO_SIDED|95.0|0.87|1.25|||ANOVA|||PT (Post-vaccination GMC; group ratio LA1:LA2)||1.25|0.87|
71143010|NCT00525512|141779764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089||||0.0003||95.0|0.041|0.137||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.137|0.041|0.0003
70951248|NCT00474526|141403405|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.05|||||TWO_SIDED|95.0|0.89|1.23|||ANOVA|||FHA (Post-vaccination GMC; group ratio LA1:LA2)||1.23|0.89|
70951249|NCT00474526|141403405|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.99|||||TWO_SIDED|95.0|0.81|1.21|||ANOVA|||Pertactin (Post-vaccination GMC; group ratio LA1:LA2)||1.21|0.81|
70951250|NCT00474526|141403405|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMTs|0.9|||||TWO_SIDED|95.0|0.68|1.17|||ANOVA|||Polio Type 1 (Post-vaccination GMT; group ratio LA1:LA2)||1.17|0.68|
71143011|NCT00525512|141779765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105|||<|0.0001||95.0|0.058|0.153||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.153|0.058|<0.0001
70951251|NCT00474526|141403405|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMTs|0.97|||||TWO_SIDED|95.0|0.73|1.28|||ANOVA|||Polio Type 2 (Post-vaccination GMT; group ratio LA1:LA2)||1.28|0.73|
70951252|NCT00474526|141403405|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMTs|0.95||||||95.0|0.69|1.31|||ANOVA|||Polio Type 3 (Post-vaccination GMT; group ratio LA1:LA2)||1.31|0.69|
70951253|NCT00474526|141403405|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.11|||||TWO_SIDED|95.0|0.88|1.4|||ANOVA|||Hepatitis B (Post-vaccination GMC; group ratio LA1:LA2)||1.4|0.88|
70951254|NCT00474526|141403405|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.27|||||TWO_SIDED|95.0|0.98|1.65|||ANOVA|||HIb (Post-vaccination GMC; group ratio LA1:LA2)||1.65|0.98|
71143012|NCT00525512|141779766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.0005||95.0|0.04|0.141||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.141|0.040|0.0005
71143013|NCT00525512|141779767|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.094||||0.0002||95.0|0.045|0.144||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.144|0.045|0.0002
71143014|NCT00525512|141779768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075||||0.0059||95.0|0.022|0.128||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.128|0.022|0.0059
71143015|NCT00525512|141779769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|||<|0.0001||95.0|0.11|0.198||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.198|0.110|<0.0001
71143016|NCT00525512|141779770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|||<|0.0001||95.0|0.117|0.208||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.208|0.117|<0.0001
70872247|NCT00407797|141229713|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Anxiety: LOCF. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||<.0001
70951255|NCT00474526|141403405|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.92|||||TWO_SIDED|95.0|0.78|1.09|||ANOVA|||PnC 4 (Post-vaccination GMC; group ratio LA1:LA2)||1.09|0.78|
70951256|NCT00474526|141403405|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.97|||||TWO_SIDED|95.0|0.74|1.27|||ANOVA|||PnC 6B (Post-vaccination GMC; group ratio LA1:LA2)||1.27|0.74|
70951257|NCT00474526|141403405|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.86|||||TWO_SIDED|95.0|0.71|1.04|||ANOVA|||PnC 9V (Post-vaccination GMC; group ratio LA1:LA2)||1.04|0.71|
70951258|NCT00474526|141403405|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.91|||||TWO_SIDED|95.0|0.72|1.14|||ANOVA|||PnC 14 (Post-vaccination GMC; group ratio LA1:LA2)||1.14|0.72|
70951259|NCT00474526|141403405|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.89|||||TWO_SIDED|95.0|0.74|1.08|||ANOVA|||PnC 18C (Post-vaccination GMC; group ratio LA1:LA2)||1.08|0.74|
70951260|NCT00474526|141403405|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.9|||||TWO_SIDED|95.0|0.74|1.1|||ANOVA|||PnC 19F (Post-vaccination GMC; group ratio LA1:LA2)||1.1|0.74|
70951261|NCT00474526|141403405|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.77|||||TWO_SIDED|95.0|0.6|0.99|||ANOVA|||PnC 23F (Post-vaccination GMC; group ratio LA1:LA2)||0.99|0.6|
70951262|NCT00474526|141403405|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.82|||||TWO_SIDED|95.0|0.69|0.99|||ANOVA|||Diphtheria (Post-vaccination GMC; group ratio LA3:LA4)||0.99|0.69|
70951263|NCT00474526|141403405|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.95|||||TWO_SIDED|95.0|0.83|1.09|||ANOVA|||Tetanus (Post-vaccination GMC; group ratio LA3:LA4)||1.09|0.83|
70951264|NCT00474526|141403405|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.93||||||95.0|0.78|1.1|||ANOVA|||PT (Post-vaccination GMC; group ratio LA3:LA4)||1.1|0.78|
71143017|NCT00525512|141779771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|||<|0.0001||95.0|0.099|0.192||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.192|0.099|<0.0001
71143018|NCT00525512|141779772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|||<|0.0001||95.0|0.077|0.176||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.176|0.077|<0.0001
70951265|NCT00474526|141403405|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.88|||||TWO_SIDED|95.0|0.75|1.03|||ANOVA|||FHA (Post-vaccination GMC; group ratio LA3:LA4)||1.03|0.75|
71143019|NCT00525512|141779773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|||<|0.0001||95.0|0.083|0.185||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.185|0.083|<0.0001
70951266|NCT00474526|141403405|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.8|||||TWO_SIDED|95.0|0.66|0.97|||ANOVA|||Pertactin (Post-vaccination GMC; group ratio LA3:LA4||0.97|0.66|
70951267|NCT00474526|141403405|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMTs|0.78|||||TWO_SIDED|95.0|0.6|1.02|||ANOVA|||Polio Type 1 (Post-vaccination GMT; group ratio LA3:LA4)||1.02|0.6|
71143020|NCT00525512|141779774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.149|||<|0.0001||95.0|0.097|0.202||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.202|0.097|<0.0001
71143021|NCT00525512|141779775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|||<|0.0001||95.0|0.077|0.183||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.183|0.077|<0.0001
71143022|NCT00525512|141779776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.217|||<|0.0001||95.0|0.127|0.307||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.307|0.127|<0.0001
71143023|NCT00525512|141779777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157||||0.0019||95.0|0.058|0.255||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.255|0.058|0.0019
70951268|NCT00474526|141403405|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMTs|0.83|||||TWO_SIDED|95.0|0.63|1.09|||ANOVA|||Polio Type 2 (Post-vaccination GMT; group ratio LA3:LA4)||1.09|0.63|
70951269|NCT00474526|141403405|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMTs|0.81|||||TWO_SIDED|95.0|0.59|1.11|||ANOVA|||Polio Type 3 (Post-vaccination GMT; group ratio LA3:LA4)||1.11|0.59|
70951270|NCT00474526|141403405|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMTs|0.95|||||TWO_SIDED|95.0|0.76|1.19|||ANOVA|||Hepatitis B (Post-vaccination GMT; group ratio LA3:LA4)||1.19|0.76|
70951271|NCT00474526|141403405|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|1.07|||||TWO_SIDED|95.0|0.83|1.37|||ANOVA|||HIb (Post-vaccination GMC; group ratio LA3:LA4)||1.37|0.83|
70951272|NCT00474526|141403405|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMTs|0.8|||||TWO_SIDED|95.0|0.68|0.95|||ANOVA|||PnC 4 (Post-vaccination GMT; group ratio LA3:LA4)||0.95|0.68|
70951273|NCT00474526|141403405|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.87|||||TWO_SIDED|95.0|0.67|1.14|||ANOVA|||PnC 6B (Post-vaccination GMC; group ratio LA3:LA4)||1.14|0.67|
70951274|NCT00474526|141403405|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.83|||||TWO_SIDED|95.0|0.69|1.0|||ANOVA|||PnC 9V (Post-vaccination GMC; group ratio LA3:LA4)||1|0.69|
70951275|NCT00474526|141403405|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.84||||||95.0|0.67|1.05|||ANOVA|||PnC 14 (Post-vaccination GMC; group ratio LA3:LA4)||1.05|0.67|
70951276|NCT00474526|141403405|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.75|||||TWO_SIDED|95.0|0.62|0.9|||ANOVA|||PnC 18C (Post-vaccination GMC; group ratio LA3:LA4)||0.9|0.62|
70951277|NCT00474526|141403405|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.91|||||TWO_SIDED|95.0|0.75|1.1|||ANOVA|||PnC 19F (Post-vaccination GMC; group ratio LA3:LA4)||1.1|0.75|
70951278|NCT00474526|141403405|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.88|||||TWO_SIDED|95.0|0.69|1.12|||ANOVA|||PnC 23F (Post-vaccination GMC; group ratio LA3:LA4)||1.12|0.69|
71143024|NCT00525512|141779778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182||||0.0006||95.0|0.078|0.286||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.286|0.078|0.0006
71143025|NCT00525512|141779779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.234|||<|0.0001||95.0|0.13|0.339||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.339|0.130|<0.0001
71143026|NCT00525512|141779780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161||||0.009||95.0|0.04|0.281||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.281|0.040|0.009
70868541|NCT01709513|141223353|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.9|||=|0.6997|TWO_SIDED|95.0|-3.8|5.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||5.6|-3.8|=0.6997
70868542|NCT00926328|141223362|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71143027|NCT00525512|141779781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.212||||0.0002||95.0|0.102|0.322||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.322|0.102|0.0002
71143028|NCT00525512|141779782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.241|||<|0.0001||95.0|0.128|0.355||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.355|0.128|<0.0001
70868543|NCT00926328|141223363|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70872248|NCT00407797|141229713|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0799|TWO_SIDED||||||t-test, 2 sided|||Depression: Week 21. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0799
71143029|NCT00525512|141779783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.277|||<|0.0001||95.0|0.179|0.375||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.375|0.179|<0.0001
71143030|NCT00525512|141779784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.325|||<|0.0001||95.0|0.226|0.425||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.425|0.226|<0.0001
71143031|NCT00525512|141779785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.353|||<|0.0001||95.0|0.245|0.461||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.461|0.245|<0.0001
70868544|NCT01227434|141223373|SUPERIORITY_OR_OTHER||Exact binomial distribution|0.1||||0.1|TWO_SIDED||||||Exact binomial distribution|||Compared to historical estimates of PFS-6 months. With 30 patients, there would be 90% power to detect an improvement in the PFS-6 months rate from 10% (historical estimate) to 30% based on a one-sided exact test with alpha=0.1.||||0.10
71143032|NCT00525512|141779786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.259|||<|0.0001||95.0|0.154|0.365||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.365|0.154|<0.0001
71143033|NCT00525512|141779787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||<|0.0001||95.0|0.194|0.406||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.406|0.194|<0.0001
71143034|NCT00525512|141779788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.254|||<|0.0001||95.0|0.144|0.364||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.364|0.144|<0.0001
71143035|NCT00525512|141779789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.333|||<|0.0001||95.0|0.209|0.456||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.456|0.209|<0.0001
71143036|NCT00525512|141779790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.1131||95.0|-0.72|0.08||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.08|-0.72|0.1131
71143037|NCT00525512|141779791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.9071||95.0|-0.38|0.33||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.33|-0.38|0.9071
71143038|NCT00525512|141779792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.6878||95.0|-0.35|0.53||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.53|-0.35|0.6878
71143039|NCT00525512|141779793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.36||||||95.0|-2.39|3.11||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.11|-2.39|
71143040|NCT00525512|141779794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||||95.0|-2.66|3.31||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.31|-2.66|
71143041|NCT00525512|141779795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||||95.0|-2.91|3.58||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.58|-2.91|
71143042|NCT00525512|141779796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||||95.0|-2.97|3.43||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.43|-2.97|
71143043|NCT00525512|141779797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||||95.0|-3.02|3.46||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.46|-3.02|
71143044|NCT00525512|141779798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||||95.0|-3.1|3.41||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.41|-3.10|
71143045|NCT00525512|141779799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||||95.0|-3.22|3.55||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.55|-3.22|
71143046|NCT00525512|141779800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||||95.0|-2.78|3.52||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.52|-2.78|
70951279|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-2.2|4.4|||ANOVA|||Diphtheria (Seroconversion percentage difference (PLA1 - PLA2))||4.4|-2.2|
70951280|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-1.9|2.6|||ANOVA|||Tetanus (Seroconversion percentage difference (PLA1 - PLA2))||2.6|-1.9|
70951281|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-7.7|7.1|||ANOVA|||PT (Seroconversion percentage difference (PLA1 - PLA2))||7.1|-7.7|
70951282|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-9.2|5.8|||ANOVA|||FHA(Seroconversion percentage difference (PLA1 - PLA2))||5.8|-9.2|
70951283|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-6.0||||||95.0|-12.9|2.2|||ANOVA|||Pertactin (Seroconversion percentage difference (PLA1 - PLA2))||2.2|-12.9|
70951284|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-4.8|1.0|||ANOVA|||Polio Type 1 (Seroconversion percentage difference (PLA1 - PLA2))||1.0|-4.8|
70951285|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-4.6|2.3|||ANOVA|||Polio Type 2 (Seroconversion percentage difference (PLA1 - PLA2))||2.3|-4.6|
71143047|NCT00525512|141779801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||||95.0|-3.05|3.51||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.51|-3.05|
71143048|NCT00525512|141779802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||||95.0|-3.4|3.55||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.55|-3.40|
70868545|NCT04613375|141223376|OTHER||Adjusted VE|16.91||||0.3685|TWO_SIDED|95.0|-24.43|44.52|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with respiratory syncytial virus (RSV) infection.|||44.52|-24.43|0.3685
70951286|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-3.2|5.1|||ANOVA|||Polio Type 3 (Seroconversion percentage difference (PLA1 - PLA2))||5.1|-3.2|
70951287|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-1.5|3.5|||ANOVA|||Hepatitis B (Seroconversion percentage difference (PLA1 - PLA2))||3.5|-1.5|
71143049|NCT00525512|141779803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||||95.0|-3.61|3.92||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.92|-3.61|
71143050|NCT00525512|141779804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||||95.0|-3.53|3.9||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.90|-3.53|
71143051|NCT00525512|141779805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||||95.0|-3.36|3.71||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.71|-3.36|
70951288|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|1.0|||||TWO_SIDED|95.0|-1.1|5.0|||ANOVA|||Hib (≥ 0.15 μg/mL)(Seroconversion percentage difference (PLA1 - PLA2))||5|-1.1|
70951289|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|2.0||||||95.0|-2.8|7.7|||ANOVA|||Hib (≥1.0 μg/mL)(Seroconversion percentage difference (PLA1 - PLA2))||7.7|-2.8|
71143052|NCT00525512|141779806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||||95.0|-3.82|3.96||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.96|-3.82|
71143053|NCT00525512|141779807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.03||||0.0072||95.0|-6.97|-1.1||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||-1.10|-6.97|0.0072
71143054|NCT00525512|141779808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33||||0.2029||95.0|-5.91|1.26||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.26|-5.91|0.2029
71143055|NCT00525512|141779809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.58||||0.0313||95.0|-6.84|-0.32||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||-0.32|-6.84|0.0313
70951290|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.0|3.3|||ANOVA|||PnC 4(Seroconversion percentage difference (PLA1 - PLA2))||3.3|-3|
70951291|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|4.0|||||TWO_SIDED|95.0|-2.2|12.3|||ANOVA|||PnC 6B(Seroconversion percentage difference (PLA1 - PLA2))||12.3|-2.2|
70951292|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.9|3.6|||ANOVA|||PnC 9V (Seroconversion percentage difference (PLA1 - PLA2))||3.6|-3.9|
70951293|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|1.0|||||TWO_SIDED|95.0|-1.1|6.2|||ANOVA|||PnC 14 (Seroconversion percentage difference (PLA1 - PLA2))||6.2|-1.1|
70951294|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-4.8|2.9|||ANOVA|||PnC 18C (Seroconversion percentage difference (PLA1 - PLA2))||2.9|-4.8|
70951295|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-4.8|2.9|||ANOVA|||PnC 19F (Seroconversion percentage difference (PLA1 - PLA2))||2.9|-4.8|
70951296|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-4.0|||||TWO_SIDED|95.0|-8.0|1.9|||ANOVA|||PnC 23F (Seroconversion percentage difference (PLA1 - PLA2))||1.9|-8|
70951297|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-2.3|3.8|||ANOVA|||Diphtheria (Seroconversion percentage difference (PLA3 - PLA4))||3.8|-2.3|
71143056|NCT00525512|141779810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.94||||0.0001||95.0|-13.37|-4.52||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||-4.52|-13.37|0.0001
71143057|NCT00525512|141779811|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.94||||0.6541||95.0|0.719|1.23||Based on a MMRM analysis with terms for treatment, centre and baseline.|Regression, Cox|||||1.230|0.719|0.6541
71143058|NCT00525512|141779812|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.06||||0.4443||95.0|0.91|1.25||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||1.25|0.91|0.4443
70951298|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0||||||95.0|-1.3|2.7|||ANOVA|||Tetanus (Seroconversion percentage difference (PLA3 - PLA4))||2.7|-1.3|
70951299|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|2.0|||||TWO_SIDED|95.0|-4.8|10.7|||Seroconversion Percentage difference|||PT (Seroconversion percentage difference (PLA3 - PLA4))||10.7|-4.8|
71143059|NCT00525512|141779813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.8644||95.0|-0.05|0.06||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||0.06|-0.05|0.8644
71143060|NCT00525512|141779814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.4277||95.0|-0.07|0.17||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||0.17|-0.07|0.4277
71143061|NCT00525512|141779815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.7071||95.0|-3.81|2.59||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||2.59|-3.81|0.7071
70951300|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-7.1|8.8|||ANOVA|||FHA(Seroconversion percentage difference (PLA3 - PLA4))||8.8|-7.1|
71143062|NCT00525512|141779816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.6556||95.0|-3.03|4.81||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||4.81|-3.03|0.6556
71143063|NCT00525512|141779817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.9896||95.0|-3.44|3.48||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||3.48|-3.44|0.9896
71143064|NCT00525512|141779818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.33||||0.0807||95.0|-9.19|0.53||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||0.53|-9.19|0.0807
71143065|NCT00402168|141779865|SUPERIORITY_OR_OTHER||Difference in Percentage|7.1|||||TWO_SIDED|95.0|2.1|14.9||||||At Month 6, difference in percentage of participants with acute rejection (number with acute rejection/number randomized) using exact method.||14.9|2.1|
71143066|NCT00402168|141779865|SUPERIORITY_OR_OTHER||Difference in Percentage|7.1|||||TWO_SIDED|95.0|2.1|14.9||||||At Month 12, difference in percentage of participants with acute rejection using exact method.||14.9|2.1|
71143067|NCT00402168|141779866|SUPERIORITY_OR_OTHER||Percent Difference|1.1|||||TWO_SIDED|95.0|-3.3|6.1||||||Participants surviving with a functioning graft by Month 6: For 95% Confidence Interval (CI) of difference, exact method was used.||6.1|-3.3|
70951301|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-8.0|5.7|||ANOVA|||Pertactin (Seroconversion percentage difference (PLA3 - PLA4))||5.7|-8|
70951302|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|4.7|||ANOVA|||Polio Type 1 (Seroconversion percentage difference (PLA3 - PLA4))||4.7|-2|
70951303|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-3.0|4.8|||ANOVA|||Polio Type 2 (Seroconversion percentage difference (PLA3 - PLA4))||4.8|-3|
70951304|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-4.4|4.5|||ANOVA|||Polio Type 3 (Seroconversion percentage difference (PLA3 - PLA4))||4.5|-4.4|
70951305|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-2.3|2.7|||ANOVA|||Hepatitis B (Seroconversion percentage difference (PLA3 - PLA4))||2.7|-2.3|
70951306|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-5.3|1.0|||ANOVA|||Hib (≥ 0.15 μg/mL)(Seroconversion percentage difference (PLA3 - PLA4))||1|-5.3|
70951307|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0||||||95.0|-6.6|3.0|||ANOVA|||Hib (≥1.0 μg/mL)(Seroconversion percentage difference (PLA3 - PLA4))||3|-6.6|
70951308|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-4.2|3.0|||ANOVA|||PnC 4 (Seroconversion percentage difference (PLA3 - PLA4))||3|-4.2|
71143068|NCT00402168|141779866|SUPERIORITY_OR_OTHER||Percent Difference|1.1|||||TWO_SIDED|95.0|-3.3|6.1||||||Participants surviving with a functioning graft by Month 12: For 95% CI of difference, exact method was used.||6.1|-3.3|
71143069|NCT00402168|141779869|SUPERIORITY_OR_OTHER||Difference|6.0|||||TWO_SIDED|95.0|-0.1|13.8||||||||13.8|-0.1|
70951309|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|2.0|||||TWO_SIDED|95.0|-4.0|9.0|||ANOVA|||PnC 6B (Seroconversion percentage difference (PLA3 - PLA4))||9|-4|
70951310|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|1.0|||||TWO_SIDED|95.0|-2.8|6.0|||ANOVA|||PnC 9V (Seroconversion percentage difference (PLA3 - PLA4))||6|-2.8|
70951311|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.7|3.4|||ANOVA|||PnC 14 (Seroconversion percentage difference (PLA3 - PLA4))||3.4|-3.7|
70951312|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-3.0|||||TWO_SIDED|95.0|-7.2|0.8|||ANOVA|||PnC 18C (Seroconversion percentage difference (PLA3 - PLA4))||0.8|-7.2|
71143070|NCT00402168|141779874|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1||||0.4491|TWO_SIDED|95.0|-1.7|3.9|||ANCOVA|||Mental Component Scales (MCS)||3.9|-1.7|0.4491
70868546|NCT04613375|141223377|OTHER||Adjusted VE|49.27||||0.0817|TWO_SIDED|95.0|-8.9|76.37|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|\<2 years||76.37|-8.9|0.0817
70951313|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|2.0|||||TWO_SIDED|95.0|-0.8|7.5|||ANOVA|||PnC 19F (Seroconversion percentage difference (PLA3 - PLA4))||7.5|-0.8|
70951314|NCT00474526|141403406|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|1.0||||||95.0|-3.7|7.0|||ANOVA|||PnC 23F (Seroconversion percentage difference (PLA3 - PLA4))||7|-3.7|
71143071|NCT00402168|141779874|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.7892|TWO_SIDED|95.0|-2.5|1.9|||ANCOVA|||Physical Component Scales (PCS)||1.9|-2.5|0.7892
71143072|NCT00402168|141779876|SUPERIORITY_OR_OTHER||Estimated Difference|0.0076|||||TWO_SIDED|95.0|-0.01|0.0252||||||Difference in Symptom Occurrence between treatment groups.||.0252|-.010|
71143073|NCT00402168|141779876|SUPERIORITY_OR_OTHER||Estimated Difference|0.0148|||||TWO_SIDED|95.0|-0.002|0.0321||||||Difference in Symptom Distress between treatment groups.||.0321|-.002|
70951315|NCT00474526|141403421|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|0.9|||||TWO_SIDED|95.0|0.67|1.2|||ANOVA|||PnC 4 (Post-vaccination GMC; group ratio US1A:US1B)||1.2|0.67|
70951316|NCT00474526|141403421|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|0.8|||||TWO_SIDED|95.0|0.62|1.02|||ANOVA|||PnC 6B (Post-vaccination GMC; group ratio US1A:US1B)||1.02|0.62|
70951317|NCT00474526|141403421|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|0.89|||||TWO_SIDED|95.0|0.67|1.2|||ANOVA|||PnC 9V (Post-vaccination GMC; group ratio US1A:US1B)||1.2|0.67|
70951318|NCT00474526|141403421|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|0.8|||||TWO_SIDED|95.0|0.63|1.03|||ANOVA|||PnC 14 (Post-vaccination GMC; group ratio US1A:US1B)||1.03|0.63|
70951319|NCT00474526|141403421|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|1.02|||||TWO_SIDED|95.0|0.78|1.34|||ANOVA|||PnC 18C (Post-vaccination GMC; group ratio US1A:US1B)||1.34|0.78|
71143074|NCT00395746|141779896|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.27|||<|0.0001||95.0|-1.51|1.02||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and HbA1C at baseline as a covariate. Two null hypotheses were statistically tested:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively. When the test of comparison between 0.9 mg+SU and SU mono was significant, the test of comparison between 0.6 mg+SU and SU mono was performed."||1.02|-1.51|<0.0001
71143075|NCT00395746|141779896|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.0|||<|0.0001||95.0|-1.24|-0.75|||ANOVA|A significance level of a two-sided 5% was used for statistical hypothesis testing.||"ANOVA model included treatment group and pre-trial SU as fixed effects and HbA1C at baseline as a covariate. Two null hypotheses were statistically tested:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively. When the test of comparison between 0.9 mg+SU and SU mono was significant, the test of comparison between 0.6 mg+SU and SU mono was performed."||-0.75|-1.24|<0.0001
70951320|NCT00474526|141403421|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|1.04||||||95.0|0.81|1.34|||ANOVA|||PnC 19F (Post-vaccination GMC; group ratio US1A:US1B)||1.34|0.81|
70951321|NCT00474526|141403421|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|0.94|||||TWO_SIDED|95.0|0.69|1.29|||ANOVA|||PnC 23F (Post-vaccination GMC; group ratio US1A:US1B)||1.29|0.69|
70951322|NCT00474526|141403422|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|1.0|||||TWO_SIDED|95.0|-8.0|10.0|||ANOVA|||PnC 4 (percentage difference (US1A - US1B))||10|-8|
70951323|NCT00474526|141403422|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|4.0|||||TWO_SIDED|95.0|0.0|10.0|||ANOVA|||PnC 6B (percentage difference (US1A - US1B))||10|0|
70951324|NCT00474526|141403422|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|-4.0|||||TWO_SIDED|95.0|-13.0|5.0|||ANOVA|||PnC 9V (percentage difference (US1A - US1B))||5|-13|
70951325|NCT00474526|141403422|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|-1.0|||||TWO_SIDED|95.0|-6.0|3.0|||ANOVA|||PnC 14 (percentage difference (US1A - US1B))||3|-6|
70951326|NCT00474526|141403422|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|-6.0|||||TWO_SIDED|95.0|-15.0|3.0|||ANOVA|||PnC 18C (percentage difference (US1A:US1B))||3|-15|
70951327|NCT00474526|141403422|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|4.0|||||TWO_SIDED|95.0|-4.0|11.0|||ANOVA|||PnC 19F (percentage difference (US1A:US1B))||11|-4|
70951328|NCT00474526|141403422|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|-2.0|||||TWO_SIDED|95.0|-10.0|5.0|||ANOVA|||PnC 239F (percentage difference (US1A:US1B))||5|-10|
70951329|NCT00474526|141403423|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.79|||||TWO_SIDED|95.0|0.61|1.02|||ANOVA|||PnC 4 (Post-vaccination GMC; group ratio LA1A:LA1B)||1.02|0.61|
70951330|NCT00474526|141403423|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.81|||||TWO_SIDED|95.0|0.54|1.2|||ANOVA|||PnC 6B (Post-vaccination GMC; group ratio LA1A:LA1B)||1.2|0.54|
70951331|NCT00474526|141403423|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.74|||||TWO_SIDED|95.0|0.58|0.94|||ANOVA|||PnC 9V (Post-vaccination GMC; group ratio LA1A:LA1B)||0.94|0.58|
70951332|NCT00474526|141403423|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.65|||||TWO_SIDED|95.0|0.51|0.82|||ANOVA|||PnC 14 (Post-vaccination GMC; group ratio LA1A:LA1B)||0.82|0.51|
70951333|NCT00474526|141403423|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.78|||||TWO_SIDED|95.0|0.6|1.01|||ANOVA|||PnC 18C (Post-vaccination GMC; group ratio LA1A:LA1B)||1.01|0.6|
70951334|NCT00474526|141403423|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.77|||||TWO_SIDED|95.0|0.56|1.04|||ANOVA|||PnC 19F (Post-vaccination GMC; group ratio LA1A:LA1B)||1.04|0.56|
70951335|NCT00474526|141403423|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.74|||||TWO_SIDED|95.0|0.54|1.01|||ANOVA|||PnC 23F (Post-vaccination GMC; group ratio LA1A:LA1B)||1.01|0.54|
70951336|NCT00474526|141403424|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|-2.0|||||TWO_SIDED|95.0|-9.6|5.2|||ANOVA|||PnC 4 (percentage difference (LA1A - LA1B))||5.2|-9.6|
71143076|NCT00395746|141779897|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.33||||||95.0|-1.62|-1.04|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-1.04|-1.62|
70951337|NCT00474526|141403424|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|-2.0|||||TWO_SIDED|95.0|-11.9|7.3|||ANOVA|||PnC 6B (percentage difference (LA1A - LA1B))||7.3|-11.9|
70951338|NCT00474526|141403424|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|-3.0|||||TWO_SIDED|95.0|-10.9|4.3|||ANOVA|||PnC 9V (percentage difference (LA1A - LA1B))||4.3|-10.9|
70951339|NCT00474526|141403424|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|-1.0|||||TWO_SIDED|95.0|-5.6|2.7|||ANOVA|||PnC 14 (percentage difference (LA1A - LA1B))||2.7|-5.6|
70951340|NCT00474526|141403424|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|-14.0|||||TWO_SIDED|95.0|-24.1|-5.6|||ANOVA|||PnC 18C (percentage difference (LA1A - LA1B))||-5.6|-24.1|
71143077|NCT00395746|141779897|SUPERIORITY_OR_OTHER||Least Squares Mean|-0.96||||||95.0|-1.25|-0.67|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-0.67|-1.25|
71143078|NCT00395746|141779898|SUPERIORITY_OR_OTHER||Least Squares Mean|-32.4|||<|0.0001||95.0|-40.5|-24.2||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%: H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively.||-24.2|-40.5|<0.0001
70951341|NCT00474526|141403424|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|-3.0|||||TWO_SIDED|95.0|-11.6|5.2|||ANOVA|||PnC 19F (percentage difference (LA1A - LA1B))||5.2|-11.6|
70951342|NCT00474526|141403424|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|0.0|||||TWO_SIDED|95.0|-7.0|7.0|||ANOVA|||PnC 23F (percentage difference (LA1A - LA1B))||7|-7|
70951343|NCT00474526|141403425|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A/GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|1.05|||||TWO_SIDED|95.0|0.86|1.27|||ANOVA|||Diphtheria (Post-vaccination GMC; group ratio LA3A:LA3B)||1.27|0.86|
70951344|NCT00474526|141403425|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|0.94|||||TWO_SIDED|95.0|0.75|1.18|||ANOVA|||Tetanus (Post-vaccination GMC; group ratio LA3A:LA3B)||1.18|0.75|
70951345|NCT00474526|141403425|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|1.11|||||TWO_SIDED|95.0|0.88|1.4|||ANOVA|||PT (Post-vaccination GMC; group ratio LA3A:LA3B)||1.4|0.88|
70951346|NCT00474526|141403425|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|1.14|||||TWO_SIDED|95.0|0.9|1.44|||ANOVA|||FHA (Post-vaccination GMC; group ratio LA3A:LA3B)||1.44|0.9|
70951347|NCT00474526|141403425|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|1.21|||||TWO_SIDED|95.0|0.92|1.59|||ANOVA|||Pertactin (Post-vaccination GMC; group ratio LA3A:LA3B||1.59|0.92|
70951348|NCT00474526|141403425|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|0.86|||||TWO_SIDED|95.0|0.63|1.16|||ANOVA|||Hib (Post-vaccination GMC; group ratio LA3A:LA3B)||1.16|0.63|
70951349|NCT00474526|141403426|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|0.0||||||95.0|-4.2|5.4|||ANOVA|||Diphtheria (percentage difference (LA3A - LA3B))||5.4|-4.2|
70951350|NCT00474526|141403426|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|0.0|||||TWO_SIDED|95.0|-4.2|5.4|||ANOVA|||Tetanus (percentage difference (LA3A - LA3B))||5.4|-4.2|
70951351|NCT00474526|141403426|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|6.0||||||95.0|-3.6|15.2|||ANOVA|||PT (percentage difference (LA3A - LA3B))||15.2|-3.6|
70951352|NCT00474526|141403426|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|-1.0|||||TWO_SIDED|95.0|-10.2|8.2|||ANOVA|||FHA (percentage difference (LA3A - LA3B))||8.2|-10.2|
70951353|NCT00474526|141403426|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|2.0|||||TWO_SIDED|95.0|-7.2|10.6|||ANOVA|||Pertactin (percentage difference (LA3A - LA3B))||10.6|-7.2|
70951354|NCT00474526|141403426|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|0.0|||||TWO_SIDED|95.0|-3.1|3.6|||ANOVA|||Hib (≥ 0.15 μg/mL) (percentage difference (LA3A - LA3B))||3.6|-3.1|
70951355|NCT00474526|141403426|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|1.0|||||TWO_SIDED|95.0|-2.2|5.3|||ANOVA|||Hib (≥1.0 μg/mL) (percentage difference (LA3A - LA3B))||5.3|-2.2|
70951356|NCT01251770|141403435|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||t-test, 2 sided|||Serum Sodium difference at the beginning||||0.030
70951357|NCT01251770|141403435|SUPERIORITY_OR_OTHER|||||||0.871||95.0|||||t-test, 2 sided|||Serum Sodium at the end of the study||||0.871
70951358|NCT01251770|141403436|SUPERIORITY_OR_OTHER|||||||0.895|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.895
70951359|NCT04024462|141403453|NON_INFERIORITY|The null hypothesis could be rejected and non-inferiority concluded if the lower bound of the 90% confidence interval of the geometric mean ratio was ≥0.8.|Geometric Mean Ratio|1.07|||||TWO_SIDED|90.0|0.99|1.15|||||The CtroughSC/CtroughIV geometric mean ratio was calculated as the SC dose of pertuzumab (Arm B) relative to the pertuzumab IV dose (Arm A).|The null hypothesis was that the pertuzumab Arm B SC dose is inferior to the pertuzumab Arm A IV dose (i.e., the CtroughSC/CtroughIV geometric mean ratio of the SC dose of pertuzumab relative to the IV dose is not greater than 0.8).||1.15|0.99|
70951360|NCT04024462|141403454|NON_INFERIORITY|The null hypothesis could be rejected and non-inferiority concluded if the lower bound of the 90% confidence interval of the geometric mean ratio was ≥0.8. Non-inferiority was tested in hierarchical order after the primary outcome measure, to adjust for multiple statistical testing and control the type I error at one sided 5% significance level.|Geometric Mean Ratio|1.55|||||TWO_SIDED|90.0|1.44|1.67|||||The CtroughSC/CtroughIV geometric mean ratio was calculated as the SC dose of trastuzumab (Arm B) relative to the trastuzumab IV dose (Arm A).|The null hypothesis was that the trastuzumab Arm B SC dose is inferior to the Arm A trastuzumab IV dose (i.e., the CtroughSC/CtroughIV geometric mean ratio of the SC dose of trastuzumab relative to the IV dose is not greater than 0.8).||1.67|1.44|
70951361|NCT04024462|141403455|OTHER|Descriptive analysis only. tpCR was analyzed outside of a hypothesis-testing framework and according to the methodology outlined in the outcome measure description.|Difference in tpCR Rate|-0.88|||||TWO_SIDED|95.0|-15.21|13.45|||||Difference in tpCR rate was calculated as Arm B: PH FDC SC minus Arm A: P+H IV.|||13.45|-15.21|
70951362|NCT00789360|141403467|OTHER||Maximum LS mean change difference|0.0917|||||TWO_SIDED|90.0|-0.028|0.212|||||Maximum difference occurred at 10 hours|The largest treatment difference (Loxapine - Placebo) in change in FEV1 from baseline by spirometry||0.212|-0.028|
70951363|NCT00789360|141403468|OTHER||Maximum LS mean change difference|-0.154|||||TWO_SIDED|90.0|-0.29|-0.019|||||Greatest difference occurred at 9 hours after Dose 1|||-0.019|-0.290|
70868547|NCT04613375|141223377|OTHER||Adjusted VE|4.72||||0.8367|TWO_SIDED|95.0|-50.96|39.87|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|2 years to \<5 years||39.87|-50.96|0.8367
70868548|NCT04613375|141223377|OTHER||Adjusted VE|12.02||||0.7469|TWO_SIDED|95.0|-91.53|59.59|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|\>=5 years||59.59|-91.53|0.7469
70868549|NCT04613375|141223383|OTHER||Adjusted VE|25.96||||0.1827|TWO_SIDED|95.0|-15.21|52.42|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|||52.42|-15.21|0.1827
70868550|NCT04613375|141223384|OTHER||Adjusted VE|68.86||||0.028|TWO_SIDED|95.0|11.86|89.0|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|\<2 years||89|11.86|0.028
70868551|NCT04613375|141223384|OTHER||Adjusted VE|7.97||||0.738|TWO_SIDED|95.0|-49.73|43.43|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|2 years to \<5 years||43.43|-49.73|0.738
70868552|NCT04613375|141223384|OTHER||Adjusted VE|30.06||||0.4327|TWO_SIDED|95.0|-70.86|71.37|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|\>=5 years||71.37|-70.86|0.4327
71143079|NCT00395746|141779898|SUPERIORITY_OR_OTHER||Least Squares Mean|-26.4|||<|0.0001||95.0|-34.5|-18.2||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%: H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively.||-18.2|-34.5|<0.0001
71143080|NCT00395746|141779899|SUPERIORITY_OR_OTHER||Least Squares Mean|-30.2||||||95.0|-39.6|-20.7|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-20.7|-39.6|
71143081|NCT00395746|141779899|SUPERIORITY_OR_OTHER||Least Squares Mean|-24.4||||||95.0|-33.8|-14.9|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-14.9|-33.8|
71143082|NCT00395746|141779900|SUPERIORITY_OR_OTHER||Least Squares Mean|-150.22|||<|0.0001||95.0|-186.32|-114.12||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||-114.12|-186.32|<0.0001
71143083|NCT00395746|141779900|SUPERIORITY_OR_OTHER||Least Squares Mean|-111.15|||<|0.0001||95.0|-147.61|-74.68||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||-74.68|-147.61|<0.0001
71143084|NCT00395746|141779901|SUPERIORITY_OR_OTHER||Least Squares Mean|-127.57||||||95.0|-166.91|-88.24|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-88.24|-166.91|
71143085|NCT00395746|141779901|SUPERIORITY_OR_OTHER||Least Squares Mean|-68.68||||||95.0|-108.91|-28.45|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-28.45|-108.91|
71143086|NCT00395746|141779902|SUPERIORITY_OR_OTHER||Least Squares Mean|-44.45|||<|0.0001||95.0|-55.02|-33.89||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||-33.89|-55.02|<0.0001
70868553|NCT00621582|141223405|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Chi-squared|||comparing results of post-treatment global assessment by patient with that of pre-treatment||||0.01
70868554|NCT00963937|141223412|SUPERIORITY_OR_OTHER||Percent Difference|-7.49||||0.345|TWO_SIDED|95.0|-23.02|8.04||Multiplicity was not considered because the primary analysis included a single statistical comparison.|Chi-squared||Percent difference = sumatriptan pooled group minus the placebo group|||8.04|-23.02|0.345
70868555|NCT00939640|141223423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17|TWO_SIDED||||||Wilcoxon matched-pairs|||||||.17
70868556|NCT00939640|141223424|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||Wilcoxon matched-pairs tests|||||||.02
70868557|NCT00939640|141223429|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||.006
70868558|NCT00939640|141223430|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||.02
70951364|NCT03559062|141403494|OTHER||||||<|0.0001|||||||Mixed-effects model for repeated measure|||||||<0.0001
70951365|NCT03559062|141403495|OTHER||||||<|0.0001|||||||Mixed-effects model for repeated measure|||||||<0.0001
70951366|NCT03559062|141403496|OTHER|||||||0.0546|||||||Mixed-effects model for repeated measure|||||||0.0546
70951367|NCT00955708|141403531|OTHER|Primary endpoint was estimated using the Kaplan-Meier method. In addition, Greenwood's formula was used to calculate the lower one-sided 95% confidence bound.|Kaplan-Meier Rate|95.3|||||ONE_SIDED|95.0|94.0||||||The lower one-sided 95% confidence bound was pre-specified to be greater than 92.5%.|The endpoint data reflected here is a modified primary endpoint analysis requested by the Food and Drug Administration early in the registry to include data that is related to the left ventricular lead function in a chronic setting.|||94.0|
70951368|NCT00955708|141403531|OTHER|Primary endpoint was estimated using the Kaplan-Meier method. In addition, Greenwood's formula was used to calculate the lower one-sided 95% confidence bound.|Kaplan-Meier Rate|100.0|||||ONE_SIDED|95.0|100.0|||||||The non-modified primary endpoint analysis initially included confirmed chronic LV lead related complications that result in permanent loss of therapy, invasive intervention, injury or death, and are deemed attributable to a structural lead failure by an independent Clinical Events Committee (CEC). These results are represented here.|||100|
70951369|NCT01016262|141403532|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0047||||||Statistical significance was assessed at the two-sided 5% level. As there was only a single pre-specified primary analysis, there was no adjustment for multiplicity.|Cochran-Mantel-Haenszel|||The comparison between MAX-002 and placebo during the DB phase with respect to the primary outcome measure was the single pre-specified primary analysis, and the null hypothesis was that the percentages were equal between the two groups.||||0.0047
70951370|NCT01016262|141403532|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0346||||||Statistical significance was assessed at the two-sided 5% level. As there was only a single pre-specified primary analysis, there was no adjustment for multiplicity.|Cochran-Mantel-Haenszel|||The comparison between Canasa® and placebo during the DB phase with respect to the primary outcome measure was a pre-specified tertiary analysis only.||||0.0346
70951371|NCT01370655|141403550|NON_INFERIORITY_OR_EQUIVALENCE|"Hypothesis supported if the upper bound of the two-sided 80% confidence interval (CI; equivalent to a one-sided upper 90% CI) is~≤0 mmHg"|Difference in Least square (LS) means|-7.4|||||TWO_SIDED|80.0|-10.6|-4.1|||||MK-7145 6 mg LS mean minus Placebo LS mean|Type I error rate of alpha=0.10 (1-sided) is specified for testing of the hypothesis.||-4.1|-10.6|
70951372|NCT01370655|141403550|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis supported if the upper bound of the two-sided 90% CI (equivalent to a one-sided upper 95% CI) for the difference ≤ 3.8 mmHg.|Difference in LS means|-5.4|||||TWO_SIDED|90.0|-9.2|-1.6|||||MK-7145 6 mg LS mean minus HCTZ 25 mg LS mean|Type I error rate of alpha=0.05 (1-sided) is specified for testing of the hypothesis.||-1.6|-9.2|
70951373|NCT01370655|141403550|SUPERIORITY_OR_OTHER||Difference in LS means|-4.8|||||TWO_SIDED|90.0|-9.0|-0.5|||||MK-7145 3 mg LS mean minus HCTZ 25 mg LS mean|||-0.5|-9.0|
70951374|NCT01370655|141403550|SUPERIORITY_OR_OTHER||Difference in LS Means|-6.7|||||TWO_SIDED|90.0|-11.2|-2.2|||||MK-7145 3 mg LS mean minus Placebo LS mean|||-2.2|-11.2|
70951375|NCT01370655|141403550|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.9|||||TWO_SIDED|90.0|-6.2|2.3|||||HCTZ 25 mg LS mean minus Placebo LS mean|||2.3|-6.2|
70951376|NCT01370655|141403551|SUPERIORITY_OR_OTHER||Difference in LS means|-3.2|||||TWO_SIDED|90.0|-6.1|-0.3|||||MK-7145 6 mg LS mean minus Placebo LS mean|||-0.3|-6.1|
70951377|NCT01370655|141403551|SUPERIORITY_OR_OTHER||Difference in LS means|-2.9|||||TWO_SIDED|90.0|-5.5|-0.2|||||MK-7145 6 mg LS mean minus HCTZ 25 mg LS mean|||-0.2|-5.5|
70951378|NCT01370655|141403551|SUPERIORITY_OR_OTHER||Difference in LS means|-3.0|||||TWO_SIDED|90.0|-6.0|-0.1|||||MK-7145 3 mg LS mean minus HCTZ 25 mg LS mean|||-0.1|-6.0|
71143087|NCT00395746|141779902|SUPERIORITY_OR_OTHER||Least Squares Mean|-34.3|||<|0.0001||95.0|-45.06|-23.54||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||-23.54|-45.06|<0.0001
70951379|NCT01370655|141403551|SUPERIORITY_OR_OTHER||Difference in LS means|-3.4|||||TWO_SIDED|90.0|-6.5|-0.2|||||MK-7145 3 mg LS mean minus Placebo LS mean|||-0.2|-6.5|
70951380|NCT01370655|141403551|SUPERIORITY_OR_OTHER||Difference in LS means|-0.3|||||TWO_SIDED|90.0|-3.3|2.7|||||HCTZ 25 mg LS mean minus Placebo LS mean|||2.7|-3.3|
70951381|NCT01370655|141403552|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis supported if the lower bound of the two-sided 80% CI (equivalent to a one-sided lower 90% CI) is \> 89.0 mmol/day.|Difference in LS means|76.5|||||TWO_SIDED|80.0|49.2|103.8|||||MK-7145 6 mg LS mean minus Placebo LS mean|Type I error rate of alpha=0.10 (1-sided) is specified for testing of the hypothesis.||103.8|49.2|
70951382|NCT01370655|141403552|SUPERIORITY_OR_OTHER||Difference in LS means|-63.7|||||TWO_SIDED|90.0|-100.8|-26.7|||||MK-7145 3 mg LS mean minus HCTZ 25 mg LS mean|||-26.7|-100.8|
70951383|NCT01370655|141403552|SUPERIORITY_OR_OTHER||Difference in LS means|-18.1|||||TWO_SIDED|90.0|-49.1|12.9|||||MK-7145 6 mg LS mean minus HCTZ 25 mg LS mean|||12.9|-49.1|
70951384|NCT01370655|141403552|SUPERIORITY_OR_OTHER||Difference in LS means|30.9|||||TWO_SIDED|90.0|-7.0|68.7|||||MK-7145 3 mg LS mean minus Placebo LS mean|||68.7|-7.0|
70951385|NCT01370655|141403552|SUPERIORITY_OR_OTHER||Difference in LS means|94.6|||||TWO_SIDED|90.0|58.8|130.4|||||HCTZ 25 mg LS mean minus Placebo LS mean|||130.4|58.8|
71143088|NCT00395746|141779903|SUPERIORITY_OR_OTHER||Least Squares Mean|-34.49||||||95.0|-46.77|-22.22|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-22.22|-46.77|
71143089|NCT00395746|141779903|SUPERIORITY_OR_OTHER||Least Squares Mean|-46.34||||||95.0|-58.49|-34.18|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-34.18|-58.49|
71143090|NCT00395746|141779904|SUPERIORITY_OR_OTHER||Least Squares Mean|-11.37||||0.0433||95.0|-22.4|-0.34||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||-0.34|-22.40|0.0433
70868559|NCT04010695|141223442|OTHER||||||<|0.001|||||||K-sample test|The p-value was calculated using a nonparametric k-sample test on the equality of medians.||Comparison of SD Biosensor POC G6PD test results for capillary and venous samples||||<0.001
70868560|NCT01235689|141223443|SUPERIORITY|||||||0.01|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by Screening smoking status (yes or no) and weight (\< 70 kg or ≥ 70 kg).||||||0.010
70868561|NCT01235689|141223444|SUPERIORITY|||||||0.014|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (\< 70 kg, ≥ 70 kg).||||||0.014
71143091|NCT00395746|141779904|SUPERIORITY_OR_OTHER||Least Squares Mean|6.67||||0.2359||95.0|-4.39|17.73||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||17.73|-4.39|0.2359
71143092|NCT00395746|141779905|SUPERIORITY_OR_OTHER||Least Squares Mean|-13.3||||||95.0|-24.69|-1.9|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-1.90|-24.69|
71143093|NCT00395746|141779905|SUPERIORITY_OR_OTHER||Least Squares Mean|-7.11||||||95.0|-18.42|4.21|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||4.21|-18.42|
71143094|NCT00395746|141779906|SUPERIORITY_OR_OTHER||Least Squares Mean|0.75||||0.0071||95.0|0.21|1.3||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||1.30|0.21|0.0071
71143095|NCT00395746|141779906|SUPERIORITY_OR_OTHER||Least Squares Mean|1.18|||<|0.0001||95.0|0.63|1.73||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||1.73|0.63|<0.0001
71143096|NCT00395746|141779907|SUPERIORITY_OR_OTHER||Least Squares Mean|1.04||||||95.0|0.42|1.66|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||1.66|0.42|
71143097|NCT00395746|141779907|SUPERIORITY_OR_OTHER||Least Squares Mean|1.13||||||95.0|0.51|1.75|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed||1.75|0.51|
71143098|NCT00395746|141779908|SUPERIORITY_OR_OTHER||Rate ratio|1.59||||||95.0|0.86|2.96|||Negative binomial regression|||The relative risk for 'All hypoglycaemic episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||2.96|0.86|
70868562|NCT01235689|141223445|SUPERIORITY|||||||0.006|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (\< 70 kg, ≥ 70 kg).||||||0.006
71143099|NCT00395746|141779908|SUPERIORITY_OR_OTHER||Rate ratio|1.18||||||95.0|0.56|2.47|||Negative binomial regression model|||The relative risk for 'Minor episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||2.47|0.56|
70868563|NCT01235689|141223446|SUPERIORITY|||||||0.01|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (\< 70 kg, ≥ 70 kg).||||||0.010
70868564|NCT01235689|141223447|SUPERIORITY|||||||0.299|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (\< 70 kg, ≥ 70 kg).||||||0.299
70868565|NCT01235689|141223448|SUPERIORITY|||||||0.728|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (\< 70 kg, ≥ 70 kg).||||||0.728
70868566|NCT01235689|141223449|SUPERIORITY|||||||0.067|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (\< 70 kg, ≥ 70 kg).||||||0.067
71143100|NCT00395746|141779908|SUPERIORITY_OR_OTHER||Rate ratio|1.8||||||95.0|0.92|3.54|||Negative binomial regression model|||The relative risk for 'Symptoms only' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||3.54|0.92|
71143101|NCT00395746|141779908|SUPERIORITY_OR_OTHER||Rate ratio|1.62||||||95.0|0.85|3.07|||Negative binomial regression model|||The relative risk for 'All hypoglycaemic episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||3.07|0.85|
71143102|NCT00395746|141779908|SUPERIORITY_OR_OTHER||Rate ratio|1.48||||||95.0|0.69|3.17|||Negative binomial regression model|||The relative risk for 'Minor episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||3.17|0.69|
71143103|NCT00395746|141779908|SUPERIORITY_OR_OTHER||Rate ratio|1.45||||||95.0|0.72|2.91|||Negative binomial regression model|||The relative risk for 'Symptoms only episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||2.91|0.72|
70868567|NCT01235689|141223450|SUPERIORITY||LS Mean Difference|-1.4||||0.116|TWO_SIDED|95.0|-3.2|0.4|||ANCOVA|Model included factors for treatment group, screening smoking status (yes or no), and weight (\< 70 kg, ≥ 70 kg), and Baseline values as covariate.||||0.4|-3.2|0.116
70868568|NCT01235689|141223452|SUPERIORITY||Cox Proportional Hazard|0.442||||0.012|TWO_SIDED|95.0|0.2|0.8|||Regression, Cox|||||0.8|0.2|0.012
70868569|NCT01235689|141223453|SUPERIORITY||Cox Proportional Hazard|1.45||||0.008|TWO_SIDED|95.0|1.1|1.9|||Regression, Cox|||||1.9|1.1|0.008
71143104|NCT03137992|141779913|EQUIVALENCE|Bioequivalence was declared if the 90% CI was entirely contained within the bioequivalence interval, 0.80 to 1.25.|Least Squared Mean Ratio|0.9369|||||TWO_SIDED|90.0|0.834|1.047|||||Fieller's formula was applied to calculate the 90% confidence interval (CI) for the Lupin Tiotropium and Spiriva Handihaler LS mean ratio.|A blinded interim analysis was performed after 241 subjects had been randomized with measurable AUC data, which estimated 238 patients would be needed to demonstrate BE with 90% power. Therefore, it was planned that approximately 378 patients would be randomized to allow for a potential 30% loss/withdrawal from the PP population.||1.047|0.834|
70868570|NCT01235689|141223454|SUPERIORITY||Cox Proportional Hazard|1.337||||0.052|TWO_SIDED|95.0|1.0|1.8|||Regression, Cox|||||1.8|1.0|0.052
70868571|NCT01235689|141223457|SUPERIORITY||Cox Proportional Hazard|0.823||||0.501|TWO_SIDED|95.0|0.5|1.5|||Regression, Cox|||||1.5|0.5|0.501
70868572|NCT01235689|141223458|SUPERIORITY||Cox Proportional Hazard|0.785||||0.459|TWO_SIDED|95.0|0.4|1.5|||Regression, Cox|||||1.5|0.4|0.459
70868573|NCT01235689|141223465|SUPERIORITY||Cox Proportional Hazard|0.423||||0.212|TWO_SIDED|95.0|0.1|1.6|||Regression, Cox|||||1.6|0.1|0.212
70868574|NCT00389597|141223476|NON_INFERIORITY_OR_EQUIVALENCE|The 95% one-sided confidence bound for testing non-inferiority using two proportion test with 10% non-inferiority margin.||||||0.0021|||||||Farrington Manning|||1 Level: Ho: pm-pc \<=-0.1 (inferiority) Alternative hypothesis: Ha: pm - pc \> -0.1 Where pm = the proportion of success in the Mobi-C group and the Pc = the proportion of success in the ACDF group.||||0.0021
70868575|NCT00389597|141223476|NON_INFERIORITY_OR_EQUIVALENCE|The 95% one-sided confidence bound for testing non-inferiority using two proportioned test with a 10% non-inferiority margin.|||||<|0.0001|||||||Farrington-Manning|||"2 Level: Ho: pm-pc \<=-0.1 (inferiority) Alternative hypothesis: Ha: pm - pc \> -0.1 Where pm = the proportion of success in the Mobi-C group and the Pc = the proportion of success in the ACDF group.~2 Level: Ho: pm-pc \<= 0 (not superior) Alternative hypothesis: Ha: pm-pc \>0 Where pm = the proportion of success in the Mobi-C group and the Pc = the proportion of success in the ACDF group."||||<0.0001
71143105|NCT03137992|141779914|SUPERIORITY||Least Squared Mean Difference|3.29|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|2.9386|3.646||Efficacy of the Test (T) product was demonstrated if the T was shown to be statistically superior to Placebo (p\<0.05 \[two-tailed\]).Outcome variable was Difference in Baseline adjusted FEV1 AUC0-24h.|Mixed Models Analysis|Mixed model repeated measures analysis consisted of effects of treatment, period, and sequence.||||3.646|2.9386|<0.001
71143106|NCT03137992|141779914|SUPERIORITY||Least Squared Mean Difference|3.43|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|3.0718|3.7797||Study sensitivity was demonstrated if the Reference (R) product was shown to be statistically superior to Placebo (P) (p \<0.05 \[two-tailed\]). Outcome variable was Difference in Baseline adjusted FEV1 AUC0-24h.|Mixed Models Analysis|Mixed model repeated measures analysis consisted of effects of treatment, period, and sequence.||||3.7797|3.0718|<0.001
71143107|NCT02392806|141779934|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71143108|NCT00301808|141779936|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier product limit|0.66|STANDARD_ERROR_OF_MEAN|0.1423|||TWO_SIDED|95.0|0.48|0.84||||||||0.84|0.48|
71143109|NCT05893862|141779948|OTHER|LS Mean Difference 1 Hr|LS Mean Difference|9.22|||<|0.0001|TWO_SIDED|90.0|7.4|11.04|||t-test, 1 sided|||||11.04|7.40|<0.0001
71143110|NCT05893862|141779948|OTHER|LS Mean Difference 2 Hr|LS Mean Difference|8.44||||0.0141|TWO_SIDED|90.0|6.31|10.56|||t-test, 1 sided|||||10.56|6.31|0.0141
71143111|NCT05893862|141779948|OTHER|LS Mean Difference 3 Hr|LS Mean Difference|10.8|||<|0.0001|TWO_SIDED|90.0|8.85|12.74|||t-test, 1 sided|||||12.74|8.85|<0.0001
71143112|NCT05893862|141779948|OTHER|LS Mean Difference Week 4 Hr|LS Mean Difference|6.43||||0.1045|TWO_SIDED|90.0|3.96|8.91|||t-test, 1 sided|||||8.91|3.96|0.1045
71143113|NCT05893862|141779948|OTHER|LS Mean Difference 8 Hr|LS Mean Difference|6.52|||||TWO_SIDED|90.0|4.66|8.38||||||||8.38|4.66|
71143114|NCT05893862|141779948|OTHER|LS Mean Difference 11 Hr|LS Mean Difference|7.33||||||90.0|4.74|9.93||||||||9.93|4.74|
71143115|NCT05893862|141779948|OTHER|LS Mean Difference 14 Hr|LS Mean Difference|6.42|||||TWO_SIDED|90.0|3.95|8.88||||||||8.88|3.95|
71143116|NCT05893862|141779948|OTHER|LS Mean Difference 24 Hr|LS Mean Difference|2.79|||||TWO_SIDED|90.0|0.81|4.76||||||||4.76|0.81|
71143117|NCT05893862|141779951|OTHER|LS Mean Difference 0.5 Hr|LS Mean Difference|0.52|||||TWO_SIDED|90.0|-1.11|2.14||||||||2.14|-1.11|
71143118|NCT05893862|141779951|OTHER|LS Mean Difference 1 Hr|LS Mean Difference|0.36|||||TWO_SIDED|90.0|-1.26|1.98||||||||1.98|-1.26|
70872249|NCT00407797|141229713|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0846|TWO_SIDED||||||t-test, 2 sided|||Depression: LOCF. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0846
71143119|NCT05893862|141779951|OTHER|LS Mean Difference 2 Hr|LS Mean Difference|1.31|||||TWO_SIDED|90.0|-1.04|3.66||||||||3.66|-1.04|
71143120|NCT05893862|141779951|OTHER|LS Mean Difference 3 hr|LS Mean Difference|4.27|||||TWO_SIDED|90.0|1.9|6.64||||||||6.64|1.90|
71143121|NCT05893862|141779951|OTHER|LS Mean Difference 4 Hr|LS Mean Difference|7.0|||||TWO_SIDED|90.0|4.35|9.64||||||||9.64|4.35|
71143122|NCT05893862|141779951|OTHER|LS Mean Difference 6 Hr|LS Mean Difference|7.85|||||TWO_SIDED|90.0|4.35|9.64||||||||9.64|4.35|
71143123|NCT05893862|141779951|OTHER|LS Mean Difference 8 Hr|LS Mean Difference|9.25|||||TWO_SIDED|90.0|6.71|11.8||||||||11.80|6.71|
71143124|NCT05893862|141779951|OTHER|LS Mean Difference 12 Hr|LS Mean Difference|4.81|||||TWO_SIDED|90.0|2.27|7.35||||||||7.35|2.27|
71143125|NCT05893862|141779951|OTHER|LS Mean Difference 14 Hr|LS Mean Difference|3.57|||||TWO_SIDED|90.0|0.91|6.23||||||||6.23|0.91|
71143126|NCT05893862|141779951|OTHER|LS Mean Difference 24 Hr|LS Mean Difference|5.01|||||TWO_SIDED|90.0|3.18|6.85||||||||6.85|3.18|
71143127|NCT05893862|141779951|OTHER|LS Mean Difference 1 Hr|LS Mean Difference|3.95|||||TWO_SIDED|90.0|1.56|6.34||||||||6.34|1.56|
71143128|NCT05893862|141779951|OTHER|LS Mean Difference 2 Hr|LS Mean Difference|3.92|||||TWO_SIDED|90.0|1.49|6.35||||||||6.35|1.49|
71143129|NCT05893862|141779951|OTHER|LS Mean Difference 3 Hr|LS Mean Difference|4.68|||||TWO_SIDED|90.0|2.33|7.03||||||||7.03|2.33|
71143130|NCT05893862|141779951|OTHER|LS Mean Difference 4 Hr|LS Mean Difference|4.79|||||TWO_SIDED|90.0|2.45|7.12||||||||7.12|2.45|
71143131|NCT05893862|141779951|OTHER|LS Mean Difference 8 Hr|LS Mean Difference|4.82|||||TWO_SIDED|90.0|1.93|7.71||||||||7.71|1.93|
71143132|NCT05893862|141779951|OTHER|LS Mean Difference 11 Hr|LS Mean Difference|5.3|||||TWO_SIDED|90.0|2.51|8.09||||||||8.09|2.51|
71143133|NCT05893862|141779951|OTHER|LS Mean Difference 14 Hr|LS Mean Difference|5.85|||||TWO_SIDED|90.0|2.97|8.74||||||||8.74|2.97|
71143134|NCT05893862|141779951|OTHER|LS Mean Difference 16 Hr|LS Mean Difference|4.12|||||TWO_SIDED|90.0|1.79|6.45||||||||6.45|1.79|
71143135|NCT05893862|141779951|OTHER|LS Mean Difference 24 Hr|LS Mean Difference|0.78|||||TWO_SIDED|90.0|-1.69|3.26||||||||3.26|-1.69|
71143136|NCT01908426|141779962|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0049|TWO_SIDED|95.0|0.63|0.92|||Log Rank|The Log-Rank Test was stratified by etiology of disease, geo. region, presence of extrahepatic spread of disease and/or macrovascular invasion.||||0.92|0.63|0.0049
71143137|NCT01908426|141779963|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.36|0.52|||Log Rank|The Log Rank Test was stratified by etiology of disease, geographic region, presence of extrahepatic spread of disease and/or macrovascular invasion.||||0.52|0.36|< 0.0001
71143138|NCT01908426|141779964|SUPERIORITY|||||||0.0086|||||||Cochran-Mantel-Haenszel|||||||0.0086
71143139|NCT03346434|141779974|SUPERIORITY||Percentage difference|23.8|||<|0.0001|TWO_SIDED|95.0|13.27|34.37||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||34.37|13.27|< 0.0001
71143140|NCT03346434|141779975|SUPERIORITY||Percentage difference|42.3|||<|0.0001|TWO_SIDED|95.0|29.47|55.16||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||55.16|29.47|< 0.0001
70868576|NCT00005044|141223477|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.45|TWO_SIDED|95.0|0.48|1.39|||Log Rank||Reference level = TAS x 8 weeks|Assuming 40% of deaths in the 8-wk arm from prostate cancer (PC) and that 8-yr DSS would be 79%, 270 PC deaths were required to detect a 33% hazard reduction in the 28-wk arm with 90% power using the log-rank test with a 2-sided significance level of 0.05. Under assumed failure rates, 1,540 patients accrued over 4 years and observed for an additional 6 years were expected to provide the requisite events. This sample accounted for a 10% ineligible/lack-of-data rate and 3 interim analyses.||1.39|0.48|0.45
71143141|NCT03346434|141779984|SUPERIORITY||Least Square (LS) Mean Difference|-50.4|||<|0.0001|TWO_SIDED|95.0|-62.38|-38.4||Threshold for significance at 0.05 level.|ANCOVA|||||-38.40|-62.38|< 0.0001
71143142|NCT03346434|141779985|SUPERIORITY||LS Mean Difference|-47.1|||<|0.0001|TWO_SIDED|95.0|-59.47|-34.79||Threshold for significance at 0.05 level.|ANCOVA|||||-34.79|-59.47|< 0.0001
71143143|NCT03346434|141779986|SUPERIORITY||Percentage difference|39.2|||<|0.0001|TWO_SIDED|95.0|26.18|52.27||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||52.27|26.18|< 0.0001
71143144|NCT03346434|141779987|SUPERIORITY||Percentage difference|43.3|||<|0.0001|TWO_SIDED|95.0|30.03|56.67||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||56.67|30.03|< 0.0001
71143145|NCT03346434|141779988|SUPERIORITY||Percentage difference|48.5|||<|0.0001|TWO_SIDED|95.0|35.03|62.0||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||62.00|35.03|< 0.0001
71143146|NCT03346434|141779989|SUPERIORITY||Percentage difference|22.5|||=|0.0001|TWO_SIDED|95.0|12.37|32.6||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||32.60|12.37|= 0.0001
70868577|NCT00005044|141223478|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.62|TWO_SIDED|95.0|0.79|1.15|||Log Rank|2-sided significance level of 0.05|Reference level = TAS x 8 weeks|With 1540 patients accrued over 4 years and observed for an additional 6 years, determined for the primary endpoint, there would be 90% power to detect a 22% reduction in the hazard of all cause deaths in the 28-week arm, with 2-sided significance level of 0.05. This sample accounted for a 10% ineligible/lack-of-data rate.||1.15|0.79|0.62
70868578|NCT00005044|141223479|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.47|TWO_SIDED|95.0|0.85|1.08|||Log Rank|Significance level = 0.05|Reference level = TAS x 8 weeks|||1.08|0.85|0.47
70868579|NCT00005044|141223480|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.07|TWO_SIDED|95.0|0.4|1.05|||Gray's test|2-sided significance level = 0.05|Reference level = TAS x 8 weeks|Locoregional progression||1.05|0.40|0.07
70868580|NCT00005044|141223480|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.8|TWO_SIDED|95.0|0.68|1.66|||Gray's test|2-sided significance level = 0.05|Reference level = TAS x 8 weeks|Distant metastasis||1.66|0.68|0.80
70868581|NCT00005044|141223481|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.74|TWO_SIDED|95.0|0.89|1.17|||Gray's test|2-sided significance level = 0.05|Reference level = TAS x 8 weeks|Protocol definition||1.17|0.89|0.74
70868582|NCT00005044|141223481|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.77|TWO_SIDED|95.0|0.79|1.19|||Gray's test|2-sided significance level = 0.05|Reference level = TAS x 8 weeks|Phoenix definition||1.19|0.79|0.77
70868583|NCT00005044|141223482|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.62|TWO_SIDED|95.0|0.64|1.3|||Log Rank|2-sided significance level = 0.05|Reference level = TAS x 8 weeks|||1.30|0.64|0.62
70868584|NCT02774954|141223554|SUPERIORITY|||||||0.35|||||||ANOVA|||||||0.35
71143147|NCT03346434|141779990|SUPERIORITY||LS Mean Difference|-24.27|||<|0.0001|TWO_SIDED|95.0|-31.204|-17.329||Threshold for significance at 0.05 level.|ANCOVA|||||-17.329|-31.204|< 0.0001
70868585|NCT02774954|141223555|SUPERIORITY|||||||0.35|||||||ANOVA|||||||0.35
70868586|NCT02229383|141223559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.101|<|0.001|TWO_SIDED|95.0|-0.94|-0.54|||Mixed Models Analysis|Treatment, region, baseline HbA1c (\< or ≥ 9.0%), baseline SU-use, week, treatment by week interaction as fixed factors; baseline value as covariate.||||-0.54|-0.94|<0.001
70868587|NCT02229383|141223560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.52|STANDARD_ERROR_OF_MEAN|0.341|<|0.001|TWO_SIDED|95.0|-2.19|-0.85|||Mixed Models Analysis|Treatment, region, baseline HbA1c (\< or ≥ 9.0%), baseline SU-use, week, treatment by week interaction as fixed factors; baseline value as covariate.||||-0.85|-2.19|<0.001
70868588|NCT02229383|141223561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.76|STANDARD_ERROR_OF_MEAN|5.754|<|0.001|TWO_SIDED|95.0|-39.07|-16.45|||ANCOVA|Treatment, region, baseline HbA1c (\< or ≥ 9.0%), baseline SU-use (yes vs. no) as fixed factors; baseline value as covariate.||||-16.45|-39.07|<0.001
70868589|NCT02229383|141223562|SUPERIORITY_OR_OTHER||Difference in percentages|25.6|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (\<9.0% or ≥9.0%) and baseline SU-use (yes vs. no).||||||<0.001
70868590|NCT02229383|141223563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|1.08||0.074|TWO_SIDED|95.0|-4.1|0.2|||Mixed Models Analysis|Treatment, region, baseline HbA1c (\< or ≥ 9.0%), baseline SU-use, week, treatment by week interaction as fixed factors; baseline value as covariate.||||0.2|-4.1|0.074
70868591|NCT02229383|141223564|SUPERIORITY_OR_OTHER||Difference in percentages|20.0|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (\<9.0% or ≥9.0%) and baseline SU-use (yes vs. no).||||||<0.001
70868592|NCT02229383|141223565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|1.13||0.11|TWO_SIDED|95.0|-4.0|0.4|||Mixed Models Analysis|Treatment, region, baseline HbA1c (\< or ≥ 9.0%), baseline SU-use, week, treatment by week interaction as fixed factors; baseline value as covariate.||||0.4|-4.0|0.110
70868593|NCT03137537|141223612|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70868594|NCT03137537|141223613|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
70868595|NCT03386448|141223616|SUPERIORITY|Student test was performed|Mean Difference (Final Values)|9.0||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
70868596|NCT01817530|141223629|SUPERIORITY||Odds Ratio (OR)|32.51|||<|0.001|TWO_SIDED|95.0|11.12|95.05||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||95.05|11.12|< 0.001
70868597|NCT01817530|141223629|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
70868598|NCT01817530|141223629|SUPERIORITY||Odds Ratio (OR)|16.66|||<|0.001|TWO_SIDED|95.0|6.72|41.3||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||41.3|6.72|< 0.001
70868599|NCT01817530|141223629|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
70868600|NCT01817530|141223629|SUPERIORITY||Odds Ratio (OR)|11.13|||<|0.001|TWO_SIDED|95.0|4.79|25.84||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||25.84|4.79|< 0.001
70868601|NCT01817530|141223629|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
70868602|NCT01817530|141223629|SUPERIORITY||Odds Ratio (OR)|19.62|||<|0.001|TWO_SIDED|95.0|7.81|49.27||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||49.27|7.81|< 0.001
71143148|NCT03346434|141779991|SUPERIORITY||LS Mean Difference|-9.1|||<|0.0001|TWO_SIDED|95.0|-11.26|-6.89||Threshold for significance at 0.05 level.|ANCOVA|||||-6.89|-11.26|< 0.0001
71143149|NCT03346434|141779992|SUPERIORITY||LS Mean Difference|-38.4|||<|0.0001|TWO_SIDED|95.0|-46.65|-30.21||Threshold for significance at 0.05 level.|ANCOVA|||||-30.21|-46.65|< 0.0001
71143150|NCT03346434|141779993|SUPERIORITY||LS Mean Difference|1.7|||<|0.0001|TWO_SIDED|95.0|1.093|2.317||Threshold significance was at 0.05 level.|ANCOVA|||||2.317|1.093|< 0.0001
70951386|NCT01370655|141403556|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the two-sided 80% CI (equivalent to a one-sided upper 90% CI) for the difference is \<13 mmol/day the hypothesis will be supported for the 3-mg dose and testing will continue with construction of a two-sided 80% CI for the 6-mg dose (6 mg MK-7145 - placebo). The hypothesis will be supported if one or both doses meet the test criterion.|Difference in LS means|7.9|||||TWO_SIDED|80.0|-2.3|18.2|||||MK-7145 3 mg LS mean minus Placebo LS mean|||18.2|-2.3|
70951387|NCT01370655|141403556|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the two-sided 80% CI (equivalent to a one-sided upper 90% CI) for the difference is \<13 mmol/day the hypothesis will be supported for the 3-mg dose and testing will continue with construction of a two-sided 80% CI for the 6-mg dose (6 mg MK-7145 - placebo). The hypothesis will be supported if one or both doses meet the test criterion.|Difference in LS means|1.1|||||TWO_SIDED|80.0|-8.5|10.7|||||MK-7145 6 mg LS mean minus Placebo LS mean|||10.7|-8.5|
70868603|NCT01817530|141223629|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
70868604|NCT01817530|141223629|SUPERIORITY||Odds Ratio (OR)|6.02|||<|0.001|TWO_SIDED|95.0|2.95|12.3||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||12.3|2.95|< 0.001
70868605|NCT01817530|141223629|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
70868606|NCT01817530|141223629|SUPERIORITY||Odds Ratio (OR)|10.34|||<|0.001|TWO_SIDED|95.0|4.79|22.34||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||22.34|4.79|< 0.001
70868607|NCT01817530|141223629|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
70868608|NCT01817530|141223630|SUPERIORITY||Odds Ratio (OR)|156.17|||<|0.001|TWO_SIDED|95.0|38.04|641.22||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||641.22|38.04|< 0.001
70868609|NCT01817530|141223630|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
70868610|NCT01817530|141223630|SUPERIORITY||Odds Ratio (OR)|66.07|||<|0.001|TWO_SIDED|95.0|21.1|206.88||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||206.88|21.1|< 0.001
70868611|NCT01817530|141223630|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
70868612|NCT01817530|141223630|SUPERIORITY||Odds Ratio (OR)|52.15|||<|0.001|TWO_SIDED|95.0|17.42|156.09||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||156.09|17.42|< 0.001
70868613|NCT01817530|141223630|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
70868614|NCT01817530|141223630|SUPERIORITY||Odds Ratio (OR)|25.45|||<|0.001|TWO_SIDED|95.0|10.45|61.96||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||61.96|10.45|< 0.001
70868615|NCT01817530|141223630|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
70951388|NCT01370655|141403556|SUPERIORITY_OR_OTHER||Difference in LS means|3.0|||||TWO_SIDED|90.0|-9.6|15.6|||||MK-7145 3 mg LS mean minus HCTZ 25 mg LS mean|||15.6|-9.6|
70951389|NCT01370655|141403556|SUPERIORITY_OR_OTHER||Difference in LS means|-3.9|||||TWO_SIDED|90.0|-15.0|7.2|||||MK-7145 6 mg LS mean minus HCTZ 25 mg LS mean|||7.2|-15.0|
70951390|NCT01370655|141403556|SUPERIORITY_OR_OTHER||Difference in LS means|5.0|||||TWO_SIDED|90.0|-7.7|17.6|||||HCTZ 25 mg LS mean minus Placebo LS mean|||17.6|-7.7|
70868616|NCT01817530|141223630|SUPERIORITY||Odds Ratio (OR)|9.65|||<|0.001|TWO_SIDED|95.0|4.38|21.25||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||21.25|4.38|< 0.001
70868617|NCT01817530|141223630|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
70868618|NCT01817530|141223630|SUPERIORITY||Odds Ratio (OR)|16.17|||<|0.001|TWO_SIDED|95.0|7.13|36.67||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||36.67|7.13|< 0.001
70868619|NCT01817530|141223630|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
70868620|NCT01817530|141223631|SUPERIORITY||Odds Ratio (OR)|123.14|||<|0.001|TWO_SIDED|95.0|25.93|584.85||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||584.85|25.93|< 0.001
70868621|NCT01817530|141223631|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
70868622|NCT01817530|141223631|SUPERIORITY||Odds Ratio (OR)|40.56|||<|0.001|TWO_SIDED|95.0|13.59|121.03||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||121.03|13.59|< 0.001
70868623|NCT01817530|141223631|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
70951391|NCT02069366|141403558|SUPERIORITY|||||||0.049||||||Applies to all rows in the Brain Measures outcome. ANOVA compared BOLD values across 6 groups for all regions (amygdala, hippocampus, vmPFC) and sessions (extinction, recall, renewal). Significance set at p \< 0.05 with Bonferroni correction.|ANOVA|||||||0.049
70868624|NCT01817530|141223631|SUPERIORITY||Odds Ratio (OR)|19.01|||<|0.001|TWO_SIDED|95.0|7.44|48.58||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||48.58|7.44|< 0.001
70951392|NCT02069366|141403559|SUPERIORITY|||||||0.049||||||"Chi-square test applied to all rows in Expectancy Ratings. Compared frequencies of Yes, No, and I don't know responses across six groups during Acquisition, Extinction, Recall, and Renewal. p \< 0.05 considered significant."|Chi-squared|||||||0.049
70868625|NCT01817530|141223631|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
70868626|NCT01817530|141223631|SUPERIORITY||Odds Ratio (OR)|22.77|||<|0.001|TWO_SIDED|95.0|9.29|55.77||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||55.77|9.29|< 0.001
70868627|NCT01817530|141223631|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
70868628|NCT01817530|141223631|SUPERIORITY||Odds Ratio (OR)|10.89|||<|0.001|TWO_SIDED|95.0|4.88|24.27||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||24.27|4.88|< 0.001
70868629|NCT01817530|141223631|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
70868630|NCT01817530|141223631|SUPERIORITY||Odds Ratio (OR)|9.72|||<|0.001|TWO_SIDED|95.0|4.46|21.22||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||21.22|4.46|< 0.001
70868631|NCT01817530|141223631|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
70868632|NCT01817530|141223632|SUPERIORITY||Odds Ratio (OR)|24.73|||<|0.001|TWO_SIDED|95.0|8.57|71.32||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||71.32|8.57|< 0.001
70868633|NCT01817530|141223632|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
70868634|NCT01817530|141223632|SUPERIORITY||Odds Ratio (OR)|17.21|||<|0.001|TWO_SIDED|95.0|6.57|45.05||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||45.05|6.57|< 0.001
70868635|NCT01817530|141223632|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
70951393|NCT02069366|141403560|SUPERIORITY|||||||0.049||||||ANOVA compared mean SUDS ratings across groups at each timepoint during extinction, recall, and renewal phases. p \< 0.05 threshold used. Exact p-values not shown due to multiple comparisons across visits and timepoints.|ANOVA|||||||0.049
70951394|NCT03119233|141403561|OTHER||Lower 97.5% Exact Confidence Limit|68.1|||||ONE_SIDED|97.5|60.9|||||||"The primary effectiveness endpoint is defined as primary patency at 12 months as evidenced by a peak systolic velocity ratio (PSVR)~≤2.5 from DUS and no clinically-driven re-intervention within the stented segment. The primary effectiveness endpoint hypotheses are:~* H0: 12-month success rate of the PQ Bypass System ≤60.4%~* HA: 12-month success rate of the PQ Bypass System \>60.4%"|||60.9|
71143151|NCT03346434|141779994|SUPERIORITY||LS Mean Difference|-3.31|||<|0.0001|TWO_SIDED|95.0|-4.029|-2.6||Threshold significance at 0.05 level.|ANCOVA|||||-2.600|-4.029|< 0.0001
70951395|NCT03119233|141403562|OTHER|The rate of freedom from 30-day MAE is expected to be no less than 92%. Based on a PG of 84% and an estimated 30-day freedom from MAE rate of 92% for the PQ Bypass System, a sample size of 169 evaluable subjects provides 88% power to test the primary safety hypothesis at the one-sided alpha level of 0.025. The Exact Test Method and Commercial software PASS14 was used to determine the sample size.|Lower 97.5% Exact Confidence Limit|93.0|||||ONE_SIDED|97.5|88.5|||||||"The primary safety endpoint hypotheses are:~* H0: 30-day Freedom from MAE rate of the PQ Bypass System~  ≤84%~* HA: 30-day Freedom from MAE rate of the PQ Bypass System \>84%"|||88.5|
70951396|NCT02057575|141403566|SUPERIORITY||||||<|0.0001||||||PG324 0.01% vs netarsudil|t-test, 2 sided|||||||<0.0001
70951397|NCT02057575|141403566|SUPERIORITY||||||<|0.0001||||||PG324 0.02% vs. netarsudil|t-test, 2 sided|||||||<0.0001
70951398|NCT02057575|141403566|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|PG324 0.01% vs. latanoprost||||||<0.0001
70951399|NCT02057575|141403566|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|PG324 0.02% vs. latanoprost||||||<0.0001
70951400|NCT01735175|141403573|EQUIVALENCE|The testing procedure was set up in a hierarchical structure, where first equivalence between LA-EP2006 and Neulasta® was assessed (margin ±1 day) and only if this was successfully established, non-inferiority between the two products was tested using a tighter margin of -0.6 days.|Mean Difference (Net)|0.07||||0.05|TWO_SIDED|95.0|-0.12|0.26|||ANCOVA|The primary endpoints was analyzed with analysis of covariance (ANCOVA).|The difference between LA-EP2006 and reference pegfilgrastim was 0.07 days (95% CI \[-0.12, 0.26\]). 95% CIs were within the predefined margin of ±1 day confirming equivalence.|"The hierarchical test procedure aimed to show that~1. LA-EP2006 and Neulasta® are equivalent with respect to DSN duration in Cycle 1 (margin±1 day), and, if so~2. LA-EP2006 is non-inferior to Neulasta® with respect to DSN duration in Cycle 1 (margin of -0.6 days)."||0.26|-0.12|0.05
70951401|NCT01735175|141403573|NON_INFERIORITY|The testing procedure was set up in a hierarchical structure, where first equivalence between LA-EP2006 and Neulasta was assessed (margin ±1 day) and only if this was successfully established, non-inferiority between the two products was tested using a tighter margin of -0.6 days.|Mean Difference (Net)|0.07||||0.05|TWO_SIDED|95.0|-0.12|0.26|||ANCOVA|The primary endpoints was analyzed with analysis of covariance (ANCOVA).|LA-EP2006 is non-inferior to Neulasta® because the lower bound of the 95% CI is entirely above the non-inferiority margin of -0.6 days.|"The hierarchical test procedure aimed to show that~1. LA-EP2006 and Neulasta® are equivalent with respect to DSN duration in Cycle 1 (margin±1 day), and, if so~2. LA-EP2006 is non-inferior to Neulasta® with respect to DSN duration in Cycle 1 (margin of -0.6 days)."||0.26|-0.12|0.05
70951402|NCT00755417|141403617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|0.38||0.0117|TWO_SIDED|97.5|-1.81|-0.11||Based on F test of type III analysis for pairwise comparison at 0.025 level.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at stable dosing Week 4||-0.11|-1.81|0.0117
70951403|NCT00755417|141403617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|0.38|<|0.0001|TWO_SIDED|97.5|-2.35|-0.66||Based on F test of type III analysis|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at stable dosing Week 4.||-0.66|-2.35|<0.0001
70951404|NCT00755417|141403618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.42||0.183|TWO_SIDED|97.5|-1.49|0.38||Based on F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at stable dosing Week 12||0.38|-1.49|0.1830
70951405|NCT00755417|141403618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.41||0.1975|TWO_SIDED|97.5|-1.46|0.4||Based on F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at stable dosing Week 12.||0.40|-1.46|0.1975
70951406|NCT00755417|141403619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.08||0.0016|TWO_SIDED|97.5|-0.44|-0.08||Based on F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dosing Week 4.||-0.08|-0.44|0.0016
70951407|NCT00755417|141403619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|97.5|-0.51|-0.14||Based on the F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dosing Week 4.||-0.14|-0.51|<0.0001
70951408|NCT00755417|141403620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0433|TWO_SIDED|97.5|-0.43|0.02||Based on the F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dosing Week 12.||0.02|-0.43|0.0433
71143152|NCT03346434|141779995|SUPERIORITY||LS Mean Difference|-7.8|||<|0.0001|TWO_SIDED|95.0|-9.789|-5.814||Threshold significance at 0.05 level.|ANCOVA|||||-5.814|-9.789|< 0.0001
71143153|NCT03346434|141779996|SUPERIORITY||LS Mean Difference|-7.5|||<|0.0001|TWO_SIDED|95.0|-10.29|-4.75||Threshold significance at 0.05 level.|ANCOVA|||||-4.75|-10.29|< 0.0001
71143154|NCT03346434|141779997|SUPERIORITY||LS Mean Difference|-8.96|||<|0.0001|TWO_SIDED|95.0|-11.711|-6.202||Threshold significance at 0.05 level.|ANCOVA|||||-6.202|-11.711|< 0.0001
71143155|NCT03346434|141779998|SUPERIORITY||||||=|0.0015||||||Threshold significance is at 0.05 level.|ANCOVA|||||||= 0.0015
71143156|NCT03346434|141779999|SUPERIORITY||LS Mean Difference|-2.9|||=|0.0997|TWO_SIDED|95.0|-6.35|0.56||Threshold significance at 0.05 level.|ANCOVA|||||0.56|-6.35|= 0.0997
71143157|NCT01782898|141780009|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.82
70868636|NCT01817530|141223632|SUPERIORITY||Odds Ratio (OR)|8.69|||<|0.001|TWO_SIDED|95.0|3.79|19.92||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||19.92|3.79|< 0.001
70868637|NCT01817530|141223632|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
70868638|NCT01817530|141223632|SUPERIORITY||Odds Ratio (OR)|18.67|||<|0.001|TWO_SIDED|95.0|7.11|49.02||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||49.02|7.11|< 0.001
70868639|NCT01817530|141223632|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
71143158|NCT01782898|141780010|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.05
71143159|NCT01782898|141780011|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.14
71143160|NCT01183689|141780014|SUPERIORITY||Mean Difference (Net)|0.82|STANDARD_ERROR_OF_MEAN|0.3|<|0.05|TWO_SIDED|95.0|0.23|1.41||No interim analyses were conducted. Pairwise differences among the three arms were assessed with a 2 degree of freedom Wald Test.|Mixed Models Analysis||Above is provided the mean difference between Arms 1 and 2.|Mean changes from random effects model applied to repeated measures to compute the average differences among groups over time.||1.41|0.23|<0.05
71143161|NCT01183689|141780014|SUPERIORITY||Mean Difference (Net)|2.64|||<|0.05|TWO_SIDED|95.0|2.05|3.22|||Mixed Models Analysis|This was fitted with Proc Mixed in SAS.|95% confidence interval excludes 0|Mean changes from a random effects model applied to repeated measures to compute the average differences between groups over time. This entry is for the comparison between groups 1 and 3.||3.22|2.05|<0.05
71143162|NCT01183689|141780015|OTHER|Generalized Estimating Equations|Odds Ratio (OR)|1.41|||<|0.05|TWO_SIDED|95.0|1.02|1.9|||Generalized Estimating Equations|||Generalized estimating equations were used to compare the average percent of weight gainers over time among the three groups. The null hypothesis was that there was no difference in these average percentages. Participants were assigned values of 0 or 1 at each visit depending on their weight gain status. The percentages were summarized with odds ratios for weight gain over time.||1.90|1.02|<0.05
71143163|NCT01183689|141780015|SUPERIORITY||Odds Ratio (OR)|2.28|||<|0.05|TWO_SIDED|95.0|1.64|3.19|||generalized estimating equations|||This is a parallel analysis, comparing groups 1 and 3, using generalized estimating equations to summarize the odds ratio for weight gain in group 1 versus group 3,||3.19|1.64|<0.05
71143164|NCT01183689|141780016|SUPERIORITY||Mean Difference (Net)|1.31|STANDARD_ERROR_OF_MEAN|0.47|<|0.05|TWO_SIDED|95.0|0.39|2.24|||Mixed Models Analysis|The p-value is based on a 2 degree of freedom Wald test within the mixed effect model to test for pairwise differences among the 3 arms.|Listed above is the mean difference between arms 1 and 2|Mean differences at 2 years are calculated from a linear contrast within a mixed effects model. Note that this comparison is between Groups 1 and 2.||2.24|0.39|<0.05
71143165|NCT01183689|141780016|SUPERIORITY||Median Difference (Net)|2.04|||<|0.05|TWO_SIDED|95.0|1.11|2.98|||Mixed Models Analysis|A linear contrast was used to compare groups 1 and 3 at 24 months.||A linear contrast from a mixed effects model was used to compare mean differences at 24 months between groups 1 and 3.||2.98|1.11|<0.05
71143166|NCT01183689|141780017|SUPERIORITY||Mean Difference (Net)|1.99||||0.13|TWO_SIDED|95.0|0.06|3.92||The p-value is from a 2 degree of freedom test for pairwise difference among the 3 arms within an analysis of variance.|ANOVA|||Analysis of variance to assess mean differences in changes from baseline in systolic blood pressure. This analysis compares groups 1 and 2.||3.92|0.06|0.13
71143167|NCT01183689|141780017|SUPERIORITY||Mean Difference (Net)|0.93||||0.13|TWO_SIDED|95.0|-0.98|2.84|||ANOVA|||Mean differences in systolic blood pressure between groups 1 and 3 over time.||2.84|-0.98|0.13
70868640|NCT01817530|141223632|SUPERIORITY||Odds Ratio (OR)|4.94|||<|0.001|TWO_SIDED|95.0|2.43|10.04||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||10.04|2.43|< 0.001
70868641|NCT01817530|141223632|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
70868642|NCT01817530|141223632|SUPERIORITY||Odds Ratio (OR)|11.76|||<|0.001|TWO_SIDED|95.0|5.17|26.79|||Regression, Logistic|P value is from a logistic regression model including treatment as the main effect and baseline value as a covariate.||||26.79|5.17|< 0.001
70868643|NCT01817530|141223632|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
70868644|NCT01817530|141223633|SUPERIORITY||Odds Ratio (OR)|31.48|||<|0.001|TWO_SIDED|95.0|10.02|98.83||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||98.83|10.02|< 0.001
70868645|NCT01817530|141223633|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
71143168|NCT01183689|141780018|SUPERIORITY||Mean Difference (Net)|1.73||||0.06|TWO_SIDED|95.0|0.32|3.14||The p-value is from a 2 degree of freedom F-test from an analysis of variance to compare mean differences among the 3 arms.|ANOVA|||Mean differences from baseline to 2 years were compared among the 3 arms using analysis of variance.||3.14|0.32|0.06
71143169|NCT01183689|141780018|SUPERIORITY||Mean Difference (Net)|0.92||||0.06|TWO_SIDED|95.0|-0.49|2.33||This p-value is from a 2 degree of freedom omnibus test for differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean changes from baseline to 2 years in diastolic blood pressure.||2.33|-0.49|0.06
71143170|NCT01183689|141780019|SUPERIORITY||Mean Difference (Net)|-1.3||||0.73|TWO_SIDED|95.0|-6.12|3.52||The p-value results from a 2 degree of freedom F-test.|ANOVA|||Mean changes from baseline to 2 years were compared between Groups 1 and 2.||3.52|-6.12|0.73
71143171|NCT01183689|141780019|SUPERIORITY||Mean Difference (Net)|-1.89||||0.73|TWO_SIDED|95.0|-4.36|0.58||This p-value is from a 2 degree of freedom test for differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean differences in total cholesterol changes from baseline among groups.||0.58|-4.36|0.73
71143172|NCT01183689|141780020|SUPERIORITY||Odds Ratio (OR)|2.36|||<|0.001|TWO_SIDED|95.0|1.23|4.52||The p-value is a 2 degree of freedom test from the generalized estimating equations analysis applied to the longitudinal binary data among the 3 study arms.|generalized estimating equations|||The average percentage of participants who were obese across follow-up were compared among the 3 arms using a generalized estimating equations approach for repeated binary measures. Participants were assigned values of 0 or 1 depending on their obesity status at each exam. Differences were summarized with odds ratios.||4.52|1.23|<0.001
71143173|NCT01183689|141780020|SUPERIORITY||Odds Ratio (OR)|2.13||||0.008|TWO_SIDED|95.0|1.12|4.1||This p-value is from a 2 degree of freedom test for differences among the 3 groups.|generalized estimating equations|||Generalized estimating equations were used. Differences were summarized with odds ratios.||4.10|1.12|0.008
70868646|NCT01817530|141223633|SUPERIORITY||Odds Ratio (OR)|14.39|||<|0.001|TWO_SIDED|95.0|5.77|35.91||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||35.91|5.77|< 0.001
70868647|NCT01817530|141223633|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
71143174|NCT01183689|141780021|SUPERIORITY||Mean Difference (Net)|-0.08||||0.002|TWO_SIDED|95.0|-0.61|0.45||the p-value results from a 2 degree of freedom F-test to assess pairwise differences among the 3 groups|ANOVA|the p-value results from a 2 degree of freedom F-test to assess pairwise differences among the 3 groups||Mean changes from baseline to 2 years among the 3 groups were assessed using a 2 degree of freedom F-test||0.45|-0.61|0.002
71143175|NCT01183689|141780021|SUPERIORITY||Mean Difference (Net)|0.55||||0.002|TWO_SIDED|95.0|0.02|1.08||This p-value is from a 2 degree of freedom test for differences among all 3 groups|ANOVA|||Differences among the 3 groups were based on analyses of variance.||1.08|0.02|0.002
71143176|NCT01183689|141780022|SUPERIORITY|A 2 degree of freedom F-test from ANOVA was used to compare mean differences in changes among the 3 arms of the study.|Mean Difference (Net)|-0.85|||<|0.001|TWO_SIDED|95.0|-1.32|-0.38||The p-value is from a 2 degree of freedom F test to assess differences among the 3 arms of the study.|ANOVA|The p-value is from a 2 degree of freedom F test to assess differences among the 3 arms of the study.||Changes in units of the scale from baseline to 2 years||-0.38|-1.32|<0.001
71143177|NCT01183689|141780022|SUPERIORITY||Mean Difference (Net)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.57|0.37||This p-value is from a 2 degree of freedom test to compare differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean changes from baseline to 2 years among the 3 groups.||0.37|-0.57|<0.001
71143178|NCT01183689|141780023|SUPERIORITY|2 degree of freedom F-test from analysis of variance to compare 2 year differences from baseline among the 3 arms of the study|Mean Difference (Net)|0.2|||<|0.001|TWO_SIDED|95.0|-0.31|0.71||2 degree of freedom F-test from analysis of variance to compare 2 year differences from baseline among the 3 arms of the study, not adjusted for multiple comparisons among endpoints|ANOVA|2 degree of freedom F-test from analysis of variance to compare 2 year differences from baseline among the 3 arms of the study||2 degree of freedom F-test from analysis of variance to compare 2 year differences from baseline among the 3 arms of the study||0.71|-0.31|<0.001
71143179|NCT01183689|141780023|SUPERIORITY||Mean Difference (Net)|0.88||||0.002|TWO_SIDED|95.0|0.37|1.39||This p-value is from a 2 degree freedom test of differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean changes from baseline to year 2 among the 3 groups.||1.39|0.37|0.002
71143180|NCT01183689|141780024|SUPERIORITY||Mean Difference (Net)|-0.13|||<|0.001|TWO_SIDED|95.0|-0.71|0.45||2 degree of freedom F-test from analysis of variance|ANOVA|2 degree of freedom F-test from analysis of variance to compare mean differences among arms||2 degree F-test from analysis of variance applied to 2 year changes in scores from baseline||0.45|-0.71|<0.001
71143181|NCT01183689|141780024|SUPERIORITY||Median Difference (Net)|1.4|||<|0.001|TWO_SIDED|95.0|0.82|1.98||This p-value is from the omnibus 2 degree of freedom test for mean differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean changes from baseline to 2 years among the 3 groups.||1.98|0.82|<0.001
71143182|NCT01183689|141780025|SUPERIORITY||Mean Difference (Net)|-0.08||||0.24|TWO_SIDED|95.0|-0.24|0.09||This p-value is from a 2 degree of freedom test for differences among the 3 arms.|ANOVA|2 degree of freedom test from analysis of variance to assess mean differences among the 3 arms||2 degree of freedom F-test from analysis of variance to compare 2 year differences in general health index values among the 3 arms||0.09|-0.24|0.24
71143183|NCT01183689|141780025|SUPERIORITY||Mean Difference (Net)|-0.15||||0.24|TWO_SIDED|95.0|-0.32|0.02||This p-value is from the 2 degree of freedom test of differences among the 3 arms.|ANOVA|||Analysis of variance was used to compare differences in changes from baseline to 2 years among the three arms.||0.02|-0.32|0.24
71143184|NCT01183689|141780026|SUPERIORITY||Mean Difference (Net)|1.52||||0.16|TWO_SIDED|95.0|-0.77|3.81||This p-value is from a 2 degree of freedom F-test to compare the 3 arms using analysis of variance.|ANOVA|||Mean differences between baseline and year 2 were compared among the 3 arms using analysis of variance.||3.81|-0.77|0.16
71143185|NCT01183689|141780026|SUPERIORITY||Mean Difference (Net)|2.21||||0.16|TWO_SIDED|95.0|-0.09|4.51||This p-value is from a 2 degree of freedom F test.|ANOVA|||Analysis of variance was used to compared mean differences among the 3 groups.||4.51|-0.09|0.16
71143186|NCT01183689|141780027|SUPERIORITY||Mean Difference (Net)|0.17||||0.75|TWO_SIDED|95.0|-3.89|4.23||This p-value is from a 2 degree of freedom F-test from analysis of variance.|ANOVA|||Mean changes from baseline to year 2 among the 3 arms were compared using analysis of variance.||4.23|-3.89|0.75
71143187|NCT01183689|141780027|SUPERIORITY||Mean Difference (Net)|1.44||||0.75|TWO_SIDED|95.0|-2.61|5.49||This p-value is from a 2 degree of freedom test.|ANOVA||No significant differences between groups 1 and 3.|Analysis of variance was used to compare mean changes among the 3 groups.||5.49|-2.61|0.75
70868648|NCT01817530|141223633|SUPERIORITY||Odds Ratio (OR)|9.82|||<|0.001|TWO_SIDED|95.0|4.23|22.8||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||22.8|4.23|< 0.001
71143188|NCT01183689|141780028|SUPERIORITY||Mean Difference (Net)|-1.08||||0.05|TWO_SIDED|95.0|-2.44|0.28||This p-value is from a 2 degree of freedom F-test to compare the 3 arms within an analysis of variance.|ANOVA||No significant difference between groups 1 and 2.|Mean changes from baseline to year 2 among the 3 arms were compared using analysis of variance.||0.28|-2.44|0.05
71143189|NCT01183689|141780028|SUPERIORITY||Mean Difference (Net)|-1.66||||0.05|TWO_SIDED|95.0|-3.0|-0.32||This p-value is from an F-test to compare differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean differences in changes from baseline to 2 years among the 3 groups.||-0.32|-3.00|0.05
71143190|NCT01183689|141780029|SUPERIORITY||Mean Difference (Net)|-0.46||||0.03|TWO_SIDED|95.0|-1.37|0.45||This p-value is from a 2 degree of freedom F-test from an analysis of variance to assess differences among the 3 arms.|ANOVA|||Mean changes between baseline and year 2 were compared among the 3 arms using analysis of variance.||0.45|-1.37|0.03
71143191|NCT01183689|141780029|SUPERIORITY||Mean Difference (Net)|-1.21||||0.03|TWO_SIDED|95.0|-2.11|-0.3||This p-value is from a 2 degree of freedom F-test to compare differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean differences from baseline to 2 years among the 3 groups.||-0.30|-2.11|0.03
71143192|NCT01183689|141780030|SUPERIORITY||Mean Difference (Net)|1.08||||0.2|TWO_SIDED|95.0|-0.84|3.0||This p-value is from a 2 degree of freedom F-test from an analysis of variance to assess mean differences among the 3 arms.|ANOVA||The 95% confidence interval for differences between groups 1 and 2 includes 0.|Mean differences from baseline to year 2 among the 3 arms were assessed using analysis of variance.||3.00|-0.84|0.20
71143193|NCT01183689|141780030|SUPERIORITY||Mean Difference (Net)|-0.05||||0.2|TWO_SIDED|95.0|-1.45|1.35||This p-value is from an analysis of variance comparing all 3 groups.|ANOVA||The 95% confidence interval for differences between groups 1 and 3 includes 0.|Analysis of variance was used to compare differences among the 3 groups.||1.35|-1.45|0.20
71143194|NCT01183689|141780031|SUPERIORITY||Mean Difference (Net)|-0.12||||0.02|TWO_SIDED|95.0|-0.34|0.1||2 degree of freedom F-test from analysis of variance, with no adjustment for multiple outcomes|ANOVA|||2 degree of freedom F-test to compare mean 2 year differences among 3 arms||0.10|-0.34|0.02
71143195|NCT01183689|141780031|SUPERIORITY||Mean Difference (Net)|-0.3||||0.02|TWO_SIDED|95.0|-0.52|-0.08||This p-value is from a 2 degree of freedom test for differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean differences in changes from baseline to 2 years among the 3 groups.||-0.08|-0.52|0.02
71143196|NCT01183689|141780032|SUPERIORITY||Mean Difference (Net)|-52.0||||0.58|TWO_SIDED|95.0|-164.0|60.0||2 degree of freedom F-test to compare 3 arms with respect to 2-year changes in kilocalories|ANOVA|||2 degree of freedom F-test to compare mean differences among 3 arms in changes in kilocalories from baseline to year 2||60|-164|0.58
71143197|NCT01183689|141780032|SUPERIORITY||Mean Difference (Net)|-50.0||||0.58|TWO_SIDED|95.0|-162.0|61.0||This p-value is from a 2 degree of freedom F-test to compare differences among the 3 groups|ANOVA|||Analysis of variance was used to assess mean differences in 2 year changes in kilocalories intake among the 3 groups.||61|-162|0.58
71143198|NCT01183689|141780033|SUPERIORITY||Mean Difference (Net)|-1.27||||0.001|TWO_SIDED|95.0|-2.55|0.02||2 degree of freedom F-test from analysis of variance to compare changes in waist circumference from baseline among the three arms|ANOVA|No adjustment to degrees of freedom|Difference between groups 1 and 2: 95% confidence interval includes 0|2 degree of freedom F-test from ANOVA to compare differences among 3 arms||0.02|-2.55|0.001
71143199|NCT01183689|141780033|SUPERIORITY||Mean Difference (Net)|-2.42||||0.001|TWO_SIDED|95.0|-3.69|-1.14||The p-value is from a 2 degree of freedom F-test for differences among the 3 arms|ANOVA||The 95% confidence interval for differences between groups 1 and 3 does not include 0.|Mean change in waist girth from baseline to year 2||-1.14|-3.69|0.001
71143200|NCT01183689|141780034|SUPERIORITY|Chi-squared test to compare the percentage of participants reporting self-weighing more than once per week among the 3 arms.|Odds Ratio (OR)|1.77||||0.004|TWO_SIDED|95.0|1.04|3.02||This is based on a 2 degree of freedom likelihood ratio test to compare differences among the 3 arms.|Regression, Logistic||The 95% confidence interval for the odds ratio comparing the rates of self-weighing at year 2 between groups 1 and 2 excludes 0.|Logistic regression to compare differences among the 3 groups||3.02|1.04|0.004
71143201|NCT01183689|141780034|SUPERIORITY||Odds Ratio (OR)|2.35||||0.004|TWO_SIDED|95.0|1.4|3.94||2 degree of freedom likelihood ratio statistic to compare differences among the 3 arms|Regression, Logistic|No adjustments|The 95% confidence interval for the odds ratio comparing groups 1 and 3 excludes 0.|Logistic regression analysis was used to compare the rates of daily self-weighing at 2 years among the 3 groups.||3.94|1.40|0.004
71143202|NCT01419236|141780036|SUPERIORITY_OR_OTHER||LS Mean Difference|0.66||||0.38|TWO_SIDED|90.0|-0.59|1.91|||Mixed Models Repeated Measure Analysis|||||1.91|-0.59|0.380
71143203|NCT01419236|141780037|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.44||||0.164|TWO_SIDED|90.0|-0.96|0.08|||Mixed Models Repeated Measures Analysis|||||0.08|-0.96|0.164
71143204|NCT01419236|141780038|SUPERIORITY_OR_OTHER||LS Mean Difference|0.42||||0.342|TWO_SIDED|90.0|-0.31|1.15|||Mixed Models Repeated Measure Analysis|||||1.15|-0.31|0.342
71143205|NCT01419236|141780039|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81||||0.079|TWO_SIDED|90.0|0.05|1.57|||Mixed Models Repeated Measure Analysis|||||1.57|0.05|0.079
71143206|NCT01419236|141780040|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.535|TWO_SIDED|90.0|-0.5|1.1|||Mixed Models Repeated Measure Analysis|||||1.10|-0.50|0.535
71143207|NCT01419236|141780041|SUPERIORITY_OR_OTHER||LS Mean Difference|1.03||||0.172|TWO_SIDED|90.0|-0.22|2.27|||ANCOVA|||||2.27|-0.22|0.172
71143208|NCT01419236|141780042|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.473|TWO_SIDED|90.0|-0.41|1.04|||Mixed Models Repeated Measure Analysis|||||1.04|-0.41|0.473
71143209|NCT01419236|141780043|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.885|TWO_SIDED|90.0|-1.03|0.87|||Mixed Models Repeated Measure Analysis|||||0.87|-1.03|0.885
71143210|NCT01419236|141780044|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.938|TWO_SIDED|90.0|-0.61|0.55|||Mixed Models Repeated Measure Analysis|||||0.55|-0.61|0.938
70868649|NCT01817530|141223633|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
70868650|NCT01817530|141223633|SUPERIORITY||Odds Ratio (OR)|16.58|||<|0.001|TWO_SIDED|95.0|6.66|41.26||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||41.26|6.66|< 0.001
70868651|NCT01817530|141223633|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
70868652|NCT01817530|141223633|SUPERIORITY||Odds Ratio (OR)|7.02|||<|0.001|TWO_SIDED|95.0|3.36|14.68||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||14.68|3.36|< 0.001
70868653|NCT01817530|141223633|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
70951409|NCT00755417|141403620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0468|TWO_SIDED|97.5|-0.42|0.03||Based on the F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dosing Week 12.||0.03|-0.42|0.0468
70951410|NCT02362503|141403621|SUPERIORITY||Mean Difference (Net)|-0.625|||<|0.0001|TWO_SIDED|95.0|-0.81|-0.441||Hypothesis test:µfostemsavir=µPlacebo where µ is a common intercept.|ANCOVA||Difference in covariate-adjusted least squares means between treatment groups (Fostemsavir 600 mg BID-Placebo) is presented.|||-0.441|-0.810|<0.0001
70951411|NCT02362503|141403622|OTHER||Mean Difference (Net)|45.69|||||TWO_SIDED|95.0|32.95|55.45|||||Difference between treatment groups (fostemsavir 600 mg BID-Placebo) and 95% confidence interval using Newcombe method is presented for \>0.5 log10 c/mL.|||55.45|32.95|
70951412|NCT02362503|141403622|OTHER||Mean Difference (Net)|35.67|||||TWO_SIDED|95.0|24.16|44.25|||||Difference between treatment groups (fostemsavir 600 mg BID-Placebo) and 95% confidence interval using Newcombe method is presented for \>1.0 log10 c/mL.|||44.25|24.16|
70951413|NCT02362503|141403628|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-16.8|16.0|||||Difference in covariate-adjusted least squares means between treatment groups (Fostemsavir 600 mg BID-Placebo) is presented.|||16.0|-16.8|
71143211|NCT02849418|141780045|OTHER||Mean Difference (Net)|-3.02|||||TWO_SIDED|95.0|-5.85|-0.19|||||The analysis method was mixed-model for repeated measures (MMRM) with treatment, visit, treatment-by-visit interaction, Baseline value, Baseline-by-visit interaction as fixed effects.|||-0.19|-5.85|
71143212|NCT00762359|141780125|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.0989|||<|0.0001|TWO_SIDED|95.0|0.0425|0.23|||Log Rank|||||0.2300|0.0425|<0.0001
70951414|NCT02362503|141403629|OTHER||Mean Difference (Net)|0.617|||||TWO_SIDED|95.0|0.082|1.151|||||Difference in covariate-adjusted least squares means between treatment groups (Fostemsavir 600 mg BID-Placebo) is presented.|||1.151|0.082|
70951415|NCT03325777|141403653|SUPERIORITY||Slope|0.71|STANDARD_ERROR_OF_MEAN|0.29|=|0.014|TWO_SIDED|95.0|0.14|1.27||a priori threshold is p\<.05|Mixed Models Analysis|Generalized Linear Mixed Models||||1.27|.14|=.014
70868654|NCT01817530|141223633|SUPERIORITY||Odds Ratio (OR)|10.73|||<|0.001|TWO_SIDED|95.0|4.85|23.76||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||23.76|4.85|< 0.001
70868655|NCT01817530|141223633|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
70868656|NCT01817530|141223634|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
70868657|NCT01817530|141223634|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
70868658|NCT01817530|141223634|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
70868659|NCT01817530|141223634|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
70868660|NCT01817530|141223634|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
70868661|NCT01817530|141223634|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
70868662|NCT01817530|141223635|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
70868663|NCT01817530|141223635|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
70868664|NCT01817530|141223635|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
70868665|NCT01817530|141223635|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
70868666|NCT01817530|141223635|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
70868667|NCT01817530|141223635|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
70868668|NCT01817530|141223636|SUPERIORITY||difference in LS mean change|-3.7|STANDARD_ERROR_OF_MEAN|1.32||0.007|TWO_SIDED|95.0|-6.28|-1.03||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||-1.03|-6.28|0.007
70951416|NCT03325777|141403654|SUPERIORITY||Mean Difference (Final Values)|172.0|STANDARD_ERROR_OF_MEAN|33.2|<|0.001|TWO_SIDED|95.0|106.0|238.0||a priori threshold for significance was p\<.05|Mixed Models Analysis|||||238|106|<.001
70951417|NCT02567708|141403674|OTHER||Posterior median difference.|0.007|STANDARD_DEVIATION|0.0468||0.57|TWO_SIDED|95.0|-0.083|0.102||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.102|-0.083|0.57
71143213|NCT00762359|141780126|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71143214|NCT00762359|141780127|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71143215|NCT00762359|141780128|SUPERIORITY_OR_OTHER|||||||0.0079||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0079
71143216|NCT00762359|141780129|SUPERIORITY_OR_OTHER|||||||0.0433||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0433
71143217|NCT00762359|141780131|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71143218|NCT00762359|141780132|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0006
70951418|NCT02567708|141403675|OTHER||Posterior median difference.|0.013|STANDARD_DEVIATION|0.0501||0.61|TWO_SIDED|95.0|-0.084|0.113||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.113|-0.084|0.61
70868669|NCT01817530|141223636|SUPERIORITY||difference in LS mean change|-1.5|STANDARD_ERROR_OF_MEAN|0.98||0.132|TWO_SIDED|95.0|-3.44|0.46||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||0.46|-3.44|0.132
70868670|NCT01817530|141223636|SUPERIORITY||difference in LS mean change|0.1|STANDARD_ERROR_OF_MEAN|0.94||0.876|TWO_SIDED|95.0|-1.71|2.0||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||2.00|-1.71|0.876
70868671|NCT01817530|141223636|SUPERIORITY||difference in LS mean change|-1.9|STANDARD_ERROR_OF_MEAN|1.0||0.055|TWO_SIDED|95.0|-3.92|0.04||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||0.04|-3.92|0.055
70868672|NCT01817530|141223636|SUPERIORITY||difference in LS mean change|0.1|STANDARD_ERROR_OF_MEAN|0.82||0.898|TWO_SIDED|95.0|-1.52|1.74||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.74|-1.52|0.898
70868673|NCT01817530|141223636|SUPERIORITY||difference in LS mean change|-0.4|STANDARD_ERROR_OF_MEAN|0.81||0.59|TWO_SIDED|95.0|-2.05|1.17||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.17|-2.05|0.59
70868674|NCT01817530|141223637|SUPERIORITY||difference in LS mean change|-1.0|STANDARD_ERROR_OF_MEAN|0.31||0.001|TWO_SIDED|95.0|-1.64|-0.42||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||-0.42|-1.64|0.001
70868675|NCT01817530|141223637|SUPERIORITY||difference in LS mean change|-1.0|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.42|-0.48||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||-0.48|-1.42|< 0.001
70868676|NCT01817530|141223637|SUPERIORITY||difference in LS mean change|-0.7|STANDARD_ERROR_OF_MEAN|0.22||0.002|TWO_SIDED|95.0|-1.12|-0.25||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||-0.25|-1.12|0.002
71143219|NCT00762359|141780133|SUPERIORITY_OR_OTHER|||||||0.0025||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0025
70868677|NCT01817530|141223637|SUPERIORITY||difference in LS mean change|-0.5|STANDARD_ERROR_OF_MEAN|0.29||0.118|TWO_SIDED|95.0|-1.04|0.12||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||0.12|-1.04|0.118
70868678|NCT01817530|141223637|SUPERIORITY||difference in LS mean change|-0.7|STANDARD_ERROR_OF_MEAN|0.24||0.004|TWO_SIDED|95.0|-1.16|-0.22||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||-0.22|-1.16|0.004
70868679|NCT01817530|141223637|SUPERIORITY||difference in LS mean change|-1.0|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.51|-0.59||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||-0.59|-1.51|< 0.001
70868680|NCT01817530|141223638|SUPERIORITY||difference in LS mean change|-0.5|STANDARD_ERROR_OF_MEAN|0.16||0.004|TWO_SIDED|95.0|-0.79|-0.15||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||||-0.15|-0.79|0.004
70868681|NCT01817530|141223638|SUPERIORITY||difference in LS mean change|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.314|TWO_SIDED|95.0|-0.4|0.13||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||||0.13|-0.4|0.314
70868682|NCT01817530|141223638|SUPERIORITY||difference in LS mean change|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.307|TWO_SIDED|95.0|-0.12|0.39||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||||0.39|-0.12|0.307
70868683|NCT01817530|141223638|SUPERIORITY||difference in LS mean change|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.106|TWO_SIDED|95.0|-0.58|0.06||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||||0.06|-0.58|0.106
70868684|NCT01817530|141223638|SUPERIORITY||difference in LS mean change|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.424|TWO_SIDED|95.0|-0.36|0.15||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||||0.15|-0.36|0.424
70951419|NCT02567708|141403676|OTHER|The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Posterior median difference|0.05|STANDARD_DEVIATION|0.0818||0.731|TWO_SIDED|95.0|-0.111|0.21|||Bayesian model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.210|-0.111|0.731
71143220|NCT00762359|141780134|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0010
71143221|NCT00762359|141780136|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||||||<0.0001
71143222|NCT00762359|141780137|SUPERIORITY_OR_OTHER|||||||0.6148||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6148
71143223|NCT00762359|141780138|SUPERIORITY_OR_OTHER|||||||0.805||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8050
70868685|NCT01817530|141223638|SUPERIORITY||difference in LS mean change|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.528|TWO_SIDED|95.0|-0.18|0.35||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||||0.35|-0.18|0.528
70868686|NCT01817530|141223639|SUPERIORITY||difference in LS means|1.3|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|0.8|1.74||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.74|0.80|< 0.001
70868687|NCT01817530|141223639|SUPERIORITY||difference in LS means|1.3|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|0.78|1.72||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.72|0.78|< 0.001
70868688|NCT01817530|141223639|SUPERIORITY||difference in LS means|0.8|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|0.33|1.27||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.27|0.33|< 0.001
70868689|NCT01817530|141223639|SUPERIORITY||difference in LS means|1.1|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|0.65|1.52||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.52|0.65|< 0.001
70868690|NCT01817530|141223639|SUPERIORITY||difference in LS means|0.7|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|0.29|1.16||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.16|0.29|< 0.001
70868691|NCT01817530|141223639|SUPERIORITY||difference in LS means|0.8|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|0.4|1.26||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.26|0.4|< 0.001
70868692|NCT01817530|141223640|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
70868693|NCT01817530|141223640|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
70868694|NCT01817530|141223640|SUPERIORITY|||||||0.018||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||0.018
70868695|NCT01817530|141223640|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
71143224|NCT00762359|141780139|SUPERIORITY_OR_OTHER|||||||0.8678||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8678
70868696|NCT01817530|141223640|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
70868697|NCT01817530|141223640|SUPERIORITY|||||||0.021||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||0.021
70868698|NCT01817530|141223640|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
71143225|NCT00762359|141780140|SUPERIORITY_OR_OTHER|||||||0.2688||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2688
70868699|NCT01817530|141223640|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
70868700|NCT01817530|141223640|SUPERIORITY|||||||0.032||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||0.032
70868701|NCT01817530|141223640|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
70868702|NCT01817530|141223640|SUPERIORITY|||||||0.007||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||0.007
70868703|NCT01817530|141223640|SUPERIORITY|||||||0.495||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||0.495
70868704|NCT01817530|141223640|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
70868705|NCT01817530|141223640|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
70868706|NCT01817530|141223640|SUPERIORITY|||||||0.015||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||0.015
71143226|NCT00762359|141780142|SUPERIORITY_OR_OTHER|||||||0.7054||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7054
71143227|NCT00762359|141780143|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3400
71143228|NCT00762359|141780144|SUPERIORITY_OR_OTHER|||||||0.8813||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8813
71143229|NCT00762359|141780145|SUPERIORITY_OR_OTHER|||||||0.1862||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1862
71143230|NCT00762359|141780147|SUPERIORITY_OR_OTHER|||||||0.8604||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8604
71143231|NCT00762359|141780148|SUPERIORITY_OR_OTHER|||||||0.5485||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5485
71143232|NCT00762359|141780149|SUPERIORITY_OR_OTHER|||||||0.7382||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7382
70951420|NCT02567708|141403677|OTHER||Posterior median difference|-0.009|STANDARD_DEVIATION|0.0712||0.44|TWO_SIDED|95.0|-0.151|0.131||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 7. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.131|-0.151|0.44
70951421|NCT02567708|141403677|OTHER||Posterior median difference|0.024|STANDARD_DEVIATION|0.057||0.66|TWO_SIDED|95.0|-0.087|0.137||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 14. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.137|-0.087|0.66
70951422|NCT02567708|141403678|OTHER||Posterior median difference|-0.021|STANDARD_DEVIATION|0.0609||0.35|TWO_SIDED|95.0|-0.14|0.099||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 7. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.099|-0.140|0.35
70951423|NCT02567708|141403678|OTHER||Posterior median difference|0.04|STANDARD_DEVIATION|0.0578||0.76|TWO_SIDED|95.0|-0.071|0.156||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 14. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.156|-0.071|0.76
71143233|NCT00762359|141780150|SUPERIORITY_OR_OTHER|||||||0.7619||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7619
71143234|NCT00762359|141780152|SUPERIORITY_OR_OTHER|||||||0.0204||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0204
70951424|NCT02567708|141403678|OTHER||Posterior median difference|0.038|STANDARD_DEVIATION|0.0559||0.76|TWO_SIDED|95.0|-0.073|0.148||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 28. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.148|-0.073|0.76
70951425|NCT02567708|141403679|OTHER||Posterior median difference|0.083|STANDARD_DEVIATION|0.6175||0.56|TWO_SIDED|95.0|-1.102|1.346||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 7. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||1.346|-1.102|0.56
71143235|NCT00762359|141780153|SUPERIORITY_OR_OTHER|||||||0.0046||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0046
71143236|NCT00762359|141780154|SUPERIORITY_OR_OTHER|||||||0.0059||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0059
70951426|NCT02567708|141403679|OTHER||Posterior median difference|0.014|STANDARD_DEVIATION|0.6672||0.51|TWO_SIDED|95.0|-1.271|1.341||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 14. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||1.341|-1.271|0.51
70951427|NCT02567708|141403679|OTHER||Posterior median difference|-0.113|STANDARD_DEVIATION|0.5148||0.41|TWO_SIDED|95.0|-1.125|0.908||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 28. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo..|||0.908|-1.125|0.41
70951428|NCT02567708|141403680|OTHER||Posterior median difference|0.5|STANDARD_DEVIATION|0.59||0.81|TWO_SIDED|95.0|-0.6|1.7||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||1.7|-0.6|0.81
71143237|NCT00762359|141780155|SUPERIORITY_OR_OTHER|||||||0.1229||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1229
71143238|NCT00762359|141780157|SUPERIORITY_OR_OTHER|||||||0.2694||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2694
71143239|NCT00762359|141780158|SUPERIORITY_OR_OTHER|||||||0.0141||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0141
71143240|NCT00762359|141780159|SUPERIORITY_OR_OTHER|||||||0.3128||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3128
71143241|NCT00762359|141780160|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1450
71143242|NCT00762359|141780162|SUPERIORITY_OR_OTHER|||||||0.6175||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6175
71143243|NCT00762359|141780163|SUPERIORITY_OR_OTHER|||||||0.4496||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4496
71143244|NCT00762359|141780164|SUPERIORITY_OR_OTHER|||||||0.4718||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4718
71143245|NCT00762359|141780165|SUPERIORITY_OR_OTHER|||||||0.4484||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4484
71143246|NCT00762359|141780167|SUPERIORITY_OR_OTHER|||||||0.2604||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2604
71143247|NCT00762359|141780168|SUPERIORITY_OR_OTHER|||||||0.6818||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6818
71143248|NCT00762359|141780169|SUPERIORITY_OR_OTHER|||||||0.9015||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.9015
71143249|NCT00762359|141780170|SUPERIORITY_OR_OTHER|||||||0.4497||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4497
71143250|NCT03287791|141780209|SUPERIORITY||Mean Difference (Final Values)|-11.27|||<|0.0001|TWO_SIDED|95.0|-16.8|-5.73|||ANOVA|||Analyses was performed using an Analysis of Variance (ANOVA) model with percent change from baseline to Week 12 in the lesion count as outcome and treatment, center and treatment-by-center interaction as factors.||-5.73|-16.80|<.0001
70868707|NCT01817530|141223640|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
70868708|NCT01817530|141223640|SUPERIORITY|||||||0.002||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||0.002
70868709|NCT01817530|141223640|SUPERIORITY|||||||0.329||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||0.329
70868710|NCT01817530|141223641|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
70868711|NCT01817530|141223641|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
70868712|NCT01817530|141223641|SUPERIORITY|||||||0.036||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||0.036
70868713|NCT01817530|141223641|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
70868714|NCT01817530|141223641|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
70868715|NCT01817530|141223641|SUPERIORITY|||||||0.04||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||||||0.040
70868716|NCT01817530|141223641|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
70868717|NCT01817530|141223641|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||||||< 0.001
71143251|NCT03287791|141780209|SUPERIORITY||Median Difference (Final Values)|-9.71||||0.0007|TWO_SIDED|95.0|-15.28|-4.14|||ANOVA|||Analyses was performed using an ANOVA model with percent change from baseline to Week 12 in the lesion count as outcome and treatment, center and treatment-by-center interaction as factors.||-4.14|-15.28|0.0007
71143252|NCT05482308|141780216|OTHER||Mean differences(Test-Reference)|98.35|||||TWO_SIDED|90.0|92.92|104.1|||Mixed effect model|"Mixed effect model was fitted to obtain:~1.Adjusted mean differences 2.90% Confidence intervals(CI)"||||104.10|92.92|
70868718|NCT01817530|141223641|SUPERIORITY|||||||0.098||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||0.098
71143253|NCT05482308|141780217|OTHER||Mean difference (Test-Reference)|91.58|||||TWO_SIDED|90.0|81.5|102.9|||Mixed effect model|"Mixed effect model was fitted to obtain:~1.Adjusted mean differences 2.90% Confidence intervals(CI)"||||102.90|81.50|
70868719|NCT01817530|141223641|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
70868720|NCT01817530|141223641|SUPERIORITY|||||||0.014||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||0.014
70868721|NCT01817530|141223641|SUPERIORITY|||||||0.409||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||0.409
70868722|NCT01817530|141223641|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
70868723|NCT01817530|141223641|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
70868724|NCT01817530|141223641|SUPERIORITY|||||||0.094||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||0.094
70868725|NCT01817530|141223641|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
70868726|NCT01817530|141223641|SUPERIORITY|||||||0.002||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||0.002
70868727|NCT01817530|141223641|SUPERIORITY|||||||0.393||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||0.393
70868728|NCT01817530|141223642|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
70868729|NCT01817530|141223642|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
70868730|NCT01817530|141223642|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
70951429|NCT02567708|141403683|OTHER||Posterior median ratio|0.89|STANDARD_DEVIATION|0.063||0.97|TWO_SIDED|95.0|0.78|1.0||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 7. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median ratio is calculated as GSK2269557 1000 μg/ Placebo.|||1.00|0.78|0.97
70951430|NCT02567708|141403683|OTHER||Posterior median ratio|0.95|STANDARD_DEVIATION|0.071||0.76|TWO_SIDED|95.0|0.83|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 14. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median ratio is calculated as GSK2269557 1000 μg/ Placebo.|||1.09|0.83|0.76
70951431|NCT02567708|141403683|OTHER||Posterior median ratio|1.0|STANDARD_DEVIATION|0.085||0.51|TWO_SIDED|95.0|0.84|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than one.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 28. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median ratio is calculated as GSK2269557 1000 μg/ Placebo.|||1.18|0.84|0.51
70951432|NCT01154140|141403705|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.454|||<|0.0001|TWO_SIDED|95.0|0.346|0.596||P-value was obtained from 1-sided log rank test, stratified by eastern cooperative oncology group performance status (ECOG PS),race,brain metastases. 1-sided log-rank test at 0.0247 level of significance was used to compare PFS between the 2 arms.|Log Rank|||||0.596|0.346|<0.0001
70951433|NCT01154140|141403706|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.0489|TWO_SIDED|95.0|0.548|1.053||P-value was obtained from 1-sided log rank test, stratified by ECOG PS, race group and brain metastases.|Log Rank||HR was calculated based on the Cox Proportional hazards model stratified by ECOG PS, race group, and brain metastases. Assuming proportional hazards, a hazard ratio (less than)\<1 indicates a reduction in hazard rate in favor of crizotinib.|||1.053|0.548|0.0489
70951434|NCT01154140|141403708|SUPERIORITY_OR_OTHER||Difference in Percentage|29.4|||<|0.0001|TWO_SIDED|95.0|19.5|39.3||P-value was obtained from a Pearson chi-square test.|Pearson chi-square test||95% CI was calculated based on normal distribution.|If the PFS endpoint was significant, ORR was to be considered significant if the 2-sided p-value from Pearson chi-square test was (less than or equal to)\<= 0.0494.||39.3|19.5|<0.0001
70951435|NCT01154140|141403711|SUPERIORITY_OR_OTHER||Difference in Percentage|10.067||||0.0381|TWO_SIDED|95.0|0.8|19.4|||Pearson chi-square test|||The confidence interval for the difference in percentage was based on normal distribution.||19.4|0.8|0.0381
70951436|NCT01154140|141403712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.441|||<|0.0001|TWO_SIDED|95.0|0.335|0.582||P-value was obtained from 1-sided unstratified log-rank test.|Log Rank|||Analysis was based on the Cox Proportional hazards model assuming proportional hazards, a HR \<1 indicated a reduction in hazard rate in favor of Crizotinib.||0.582|0.335|<0.0001
70951437|NCT01154140|141403713|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.595||||0.0347|TWO_SIDED|95.0|0.338|1.048||P-value was obtained from 1-sided unstratified log-rank test.|Log Rank|||Analysis was based on the Cox Proportional hazards model assuming proportional hazards, a HR less than 1 indicated a reduction in hazard rate in favor of Crizotinib.||1.048|0.338|0.0347
70951438|NCT01154140|141403714|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.387|||<|0.0001|TWO_SIDED|95.0|0.286|0.524||P-value was obtained from 1-sided unstratified log-rank test.|Log Rank|||Analysis was based on the Cox Proportional hazards model assuming proportional hazards, a HR less than 1 indicated a reduction in hazard rate in favor of Crizotinib.||0.524|0.286|<0.0001
70951439|NCT01154140|141403721|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.591||||0.0002|TWO_SIDED|95.0|0.452|0.773||Two-sided p-value from the unstratified log rank test was used.|Log Rank|||HR was calculated based on the Cox Proportional hazards model. Assuming proportional hazards, a HR less than 1 indicated a reduction in hazard rate in favor of crizotinib.||0.773|0.452|0.0002
70951440|NCT01154140|141403722|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.8303|||<|0.0001|TWO_SIDED|95.0|10.74|16.92|||Mixed Models Analysis|||QLQ-C30 Global QoL: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||16.92|10.74|<0.0001
70951441|NCT01154140|141403722|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.3532||||0.017|TWO_SIDED|95.0|0.6|6.11|||Mixed Models Analysis|||QLQ-C30 cognitive functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||6.11|0.60|0.0170
70951442|NCT01154140|141403722|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.5165|||<|0.0001|TWO_SIDED|95.0|4.57|10.46|||Mixed Models Analysis|||QLQ-C30 emotional functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||10.46|4.57|<0.0001
70951443|NCT01154140|141403722|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.4035|||<|0.0001|TWO_SIDED|95.0|7.48|13.32|||Mixed Models Analysis|||QLQ-C30 physical functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||13.32|7.48|<0.0001
70951444|NCT01154140|141403722|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.5513|||<|0.0001|TWO_SIDED|95.0|11.29|19.81|||Mixed Models Analysis|||QLQ-C30 role functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||19.81|11.29|<0.0001
70951445|NCT01154140|141403722|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.7641|||<|0.0001|TWO_SIDED|95.0|4.69|12.84|||Mixed Models Analysis|||QLQ-C30 social functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||12.84|4.69|<0.0001
70951446|NCT01154140|141403723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.4976|||<|0.0001|TWO_SIDED|95.0|-18.03|-8.97|||Mixed Models Analysis|||QLQ-C30 appetite loss: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||-8.97|-18.03|<0.0001
70951447|NCT01154140|141403723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.4336||||0.057|TWO_SIDED|95.0|-9.0|0.13|||Mixed Models Analysis|||QLQ-C30 constipation: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||0.13|-9.00|0.0570
70951448|NCT01154140|141403723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.4906|||<|0.0001|TWO_SIDED|95.0|8.98|16.0|||Mixed Models Analysis|||QLQ-C30 diarrhea: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||16.00|8.98|<0.0001
70951449|NCT01154140|141403723|SUPERIORITY_OR_OTHER||Median Difference (Net)|-13.4622|||<|0.0001|TWO_SIDED|95.0|-17.2|-9.73|||Mixed Models Analysis|||QLQ-C30 dysponea: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||-9.73|-17.20|<0.0001
70951450|NCT01154140|141403723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.9987|||<|0.0001|TWO_SIDED|95.0|-18.52|-11.48|||Mixed Models Analysis|||QLQ-C30 fatigue: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||-11.48|-18.52|<0.0001
70951451|NCT01154140|141403723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8186||||0.6681|TWO_SIDED|95.0|-4.56|2.92|||Mixed Models Analysis|||QLQ-C30 financial difficulties: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||2.92|-4.56|0.6681
70951452|NCT01154140|141403723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.043|||<|0.0001|TWO_SIDED|95.0|-14.22|-5.87|||Mixed Models Analysis|||QLQ-C30 insomnia: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||-5.87|-14.22|<0.0001
70951453|NCT01154140|141403723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.4446||||0.0468|TWO_SIDED|95.0|-6.84|-0.05|||Mixed Models Analysis|||QLQ-C30 nausea and vomiting: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||-0.05|-6.84|0.0468
71143259|NCT02250326|141780260|SUPERIORITY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.9|1.94||||Based on stratification factors of ECOG Performance Status (0 or 1), sex (male or female), and current smoker status (yes or no).||Based on stratified Cox proportional hazards regression model.||1.94|0.90|
70951454|NCT01154140|141403723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.9277|||<|0.0001|TWO_SIDED|95.0|-13.23|-6.62|||Mixed Models Analysis|||QLQ-C30 pain: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||-6.62|-13.23|<0.0001
70951455|NCT01154140|141403724|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.8149||||0.0108|TWO_SIDED|95.0|-8.52|-1.11|||Mixed Models Analysis|||QLQ-LC13 alopecia: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||-1.11|-8.52|0.0108
70951456|NCT01154140|141403724|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.3926|||<|0.0001|TWO_SIDED|95.0|-12.06|-4.72|||Mixed Models Analysis|||QLQ-LC13 coughing: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||-4.72|-12.06|<0.0001
71143260|NCT02250326|141780261|SUPERIORITY||Disease Control Rate Ratio|0.97|||||TWO_SIDED|95.0|0.778|1.207|||||95% CI was calculated using Clopper-Pearson method.||Direction of Disease Control Rate Ratio is DCR of Nab-Paclitaxel + CC-486 Combination Arm over DCR of Nab-Paclitaxel Alone|1.207|0.778|
70868731|NCT01817530|141223642|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
70951457|NCT01154140|141403724|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6651||||0.5938|TWO_SIDED|95.0|-1.78|3.11|||Mixed Models Analysis|||QLQ-LC13 dysphagia: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||3.11|-1.78|0.5938
70951458|NCT01154140|141403724|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.008|||<|0.0001|TWO_SIDED|95.0|-11.96|-6.06|||Mixed Models Analysis|||QLQ-LC13 dyspnoea: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||-6.06|-11.96|<0.0001
70951459|NCT01154140|141403724|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8828||||0.0656|TWO_SIDED|95.0|-1.82|0.06|||Mixed Models Analysis|||QLQ-LC13 haemoptysis: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||0.06|-1.82|0.0656
70951460|NCT01154140|141403724|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.0475||||0.0002|TWO_SIDED|95.0|-9.22|-2.88|||Mixed Models Analysis|||QLQ-LC13 pain in arm or shoulder: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||-2.88|-9.22|0.0002
70951461|NCT01154140|141403724|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.0959|||<|0.0001|TWO_SIDED|95.0|-11.35|-4.84|||Mixed Models Analysis|||QLQ-LC13 pain in chest: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||-4.84|-11.35|<0.0001
70951462|NCT01154140|141403724|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.7717||||0.0001|TWO_SIDED|95.0|-10.24|-3.31|||Mixed Models Analysis|||QLQ-LC13 pain in other parts: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||-3.31|-10.24|0.0001
70951463|NCT01154140|141403724|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.3521||||0.0427|TWO_SIDED|95.0|0.11|6.59|||Mixed Models Analysis|||QLQ-LC13 peripheral neuropathy: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||6.59|0.11|0.0427
70951464|NCT01154140|141403724|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.1521||||0.1382|TWO_SIDED|95.0|-5.0|0.69|||Mixed Models Analysis|||QLQ-LC13 sore mouth: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||0.69|-5.00|0.1382
70951465|NCT01154140|141403725|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.9908||||0.0139|TWO_SIDED|95.0|0.81|7.17|||Mixed Models Analysis|||Analysis was based on a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EQ-5D VAS subscale baseline score (intercept and time from first dose were included as random effects).||7.17|0.81|0.0139
70951466|NCT00478192|141403729|SUPERIORITY_OR_OTHER|||||||0.028||95.0||||P-Values are not adjusted on the basis of multiple comparrisons|ANCOVA|||"Statistical Analysis applies to Change from Baseline."||||0.028
71143261|NCT02250326|141780262|SUPERIORITY||Overall Response Rate Ratio|0.84|||||TWO_SIDED|95.0|0.398|1.754|||||95% CI was calculated using Clopper-Pearson method.||Direction of Overall Response Rate Ratio is ORR of Nab-Paclitaxel + CC-486 Combination Arm over ORR of nab-Paclitaxel Alone.|1.754|0.398|
70868732|NCT01817530|141223642|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
71143262|NCT02250326|141780263|SUPERIORITY||Hazard Ratio (HR)|1.7|||||TWO_SIDED|95.0|1.08|2.57||||Based on stratification factors of ECOG performance status (0 or 1), sex (male or female), and current smoker status (yes or no).||Based on stratified Cox proportional hazards regression model.||2.57|1.08|
70868733|NCT01817530|141223642|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
70951467|NCT00478192|141403729|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-Values are not adjusted on the basis of multiple comparrisons|ANCOVA|||"Statistical Analysis applies to Change from Baseline."||||0.019
70951468|NCT00478192|141403729|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Values are not adjusted on the basis of multiple comparrisons|ANCOVA|||"Statistical Analysis applies to Change from Baseline."||||<0.001
70951469|NCT00478192|141403734|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||ANCOVA|||||||0.079
70951470|NCT00477490|141403742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9303|TWO_SIDED|95.0|-0.221|0.242||The a priori statistically significant difference versus placebo is p≤0.05.|ANCOVA|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||||0.242|-0.221|0.9303
70951471|NCT00477490|141403742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.3104|TWO_SIDED|95.0|-0.353|0.112||The a priori statistically significant difference versus placebo is p≤0.05.|ANCOVA|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||||0.112|-0.353|0.3104
70951472|NCT00477490|141403742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.277||||0.0207|TWO_SIDED|95.0|-0.511|-0.042||The a priori statistically significant difference versus placebo is p≤0.05.|ANCOVA|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||The trial was to be declared positive only if in the 100 μg group, a statistically significant positive effect as compared to placebo on both co-primaries was demonstrated. And only then, the next higher dose group (i.e., 50 μg) could be claimed superior to placebo, if it showed a statistically significant improvement over placebo on both co-primaries.||-0.042|-0.511|0.0207
70951473|NCT00477490|141403742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.613|||<|0.0001|TWO_SIDED|95.0|-0.848|-0.378||The a priori statistically significant difference versus placebo is p≤0.05.|ANCOVA|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||The trial was to be declared positive only if in the 100 μg group, a statistically significant positive effect as compared to placebo on both co-primaries was demonstrated. And only then, the next higher dose group (i.e., 50 μg) could be claimed superior to placebo, if it showed a statistically significant improvement over placebo on both co-primaries.||-0.378|-0.848|<0.0001
70951474|NCT00477490|141403743|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.017||||0.942|TWO_SIDED|95.0|0.647|1.598||The a priori statistically significant difference versus placebo is p≤0.05.|Regression, Logistic|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids||||1.598|0.647|0.9420
70951475|NCT00477490|141403743|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.147||||0.5527|TWO_SIDED|95.0|0.729|1.807||The a priori statistically significant difference versus placebo is p≤0.05.|Regression, Logistic|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||||1.807|0.729|0.5527
70951476|NCT00477490|141403743|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.296||||0.2662|TWO_SIDED|95.0|0.821|2.05||The a priori statistically significant difference versus placebo is p≤0.05.|Regression, Logistic|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||The trial was to be declared positive only if in the 100 μg group, a statistically significant positive effect as compared to placebo on both co-primaries was demonstrated. And only then, the next higher dose group (i.e., 50 μg) could be claimed superior to placebo, if it showed a statistically significant improvement over placebo on both co-primaries.||2.050|0.821|0.2662
70951477|NCT00477490|141403743|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.893|||<|0.0001|TWO_SIDED|95.0|1.795|4.715||The a priori statistically significant difference versus placebo is p≤0.05.|Regression, Logistic|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||The trial was to be declared positive only if in the 100 μg group, a statistically significant positive effect as compared to placebo on both co-primaries was demonstrated. And only then, the next higher dose group (i.e., 50 μg) could be claimed superior to placebo, if it showed a statistically significant improvement over placebo on both co-primaries.||4.715|1.795|<0.0001
70951478|NCT01646177|141403754|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
70951479|NCT01646177|141403754|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
70951480|NCT01646177|141403754|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
70951481|NCT01646177|141403755|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
70951482|NCT01646177|141403755|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
70951483|NCT01646177|141403755|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
70951484|NCT01646177|141403756|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
70951485|NCT01646177|141403756|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
70951486|NCT01646177|141403756|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
70951487|NCT01646177|141403757|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
70951488|NCT01646177|141403757|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
70951489|NCT01646177|141403757|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
70951490|NCT01646177|141403758|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
70951491|NCT01646177|141403758|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
70951492|NCT01646177|141403758|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
70951493|NCT01646177|141403759|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
70951494|NCT01646177|141403759|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
70951495|NCT01646177|141403759|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
70951496|NCT01646177|141403760|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
70951497|NCT01646177|141403760|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
70951498|NCT01646177|141403760|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
70951499|NCT01646177|141403761|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
70951500|NCT01646177|141403761|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
70951501|NCT01646177|141403761|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
70951502|NCT01646177|141403762|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
70951503|NCT01646177|141403762|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
70951504|NCT01646177|141403762|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
70951505|NCT01646177|141403763|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
70951506|NCT01646177|141403763|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
70951507|NCT01646177|141403763|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
70951508|NCT01646177|141403764|SUPERIORITY_OR_OTHER_LEGACY|||||||0.473|TWO_SIDED||||||ANCOVA|||||||0.473
70951509|NCT01646177|141403764|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015|TWO_SIDED||||||ANCOVA|||||||0.015
70951510|NCT01646177|141403764|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
70951511|NCT01646177|141403765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|TWO_SIDED||||||ANCOVA|||Includes analysis only from Absenteeism Score.||||0.006
70951512|NCT01646177|141403765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.045|TWO_SIDED||||||ANCOVA|||Includes analysis only from Absenteeism Score.||||0.045
70951513|NCT01646177|141403765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|TWO_SIDED||||||ANCOVA|||Includes analysis only from Absenteeism Score.||||0.012
70951514|NCT01646177|141403765|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Activity Impairment Score.||||<0.001
70951515|NCT01646177|141403765|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Activity Impairment Score.||||<0.001
70951516|NCT01646177|141403765|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Activity Impairment Score.||||<0.001
70951517|NCT01646177|141403765|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Presenteeism Score.||||<0.001
70951518|NCT01646177|141403765|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Presenteeism Score.||||<0.001
70951519|NCT01646177|141403765|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Presenteeism Score.||||<0.001
71143263|NCT00416624|141780270|NON_INFERIORITY_OR_EQUIVALENCE|If the hematopoietic response rate in the standard therapy group is far from 50% (\<25% or \>75%), the\> above sample size will provide an 80% power to detect a difference as small as\> 25%.|||||>|0.41|TWO_SIDED||||||Fisher Exact|||With 80 patients per treatment arm, there will be\> about 80% power to detect a difference through Fisher's exact test across two\> treatment arms of 25% in the true percentage of patients that experience a\> hematopoietic response as defined previously, if that percentage is at least 30% in\> the superior group, again with a 1.7% type I error rate.||||>0.41
71143264|NCT00416624|141780272|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 80 patients per arm will provide\> 80% power to detect differences between average hemoglobin levels in the\> reference arm and another treatment of 50% of the standard deviation. Note that\> typically one would expect the estimates for the standard deviation at a single time\> point to differ from the standard deviation for the difference from baseline.|||||>|0.13|TWO_SIDED||||||Fisher Exact|||||||>0.13
70868734|NCT01817530|141223642|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
70951520|NCT01646177|141403765|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Work Productively Loss Score.||||<0.001
70951521|NCT01646177|141403765|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Work Productively Loss Score.||||<0.001
70868735|NCT01817530|141223642|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
70868736|NCT01817530|141223642|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
70951522|NCT01646177|141403765|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Work Productively Loss Score.||||<0.001
70951523|NCT01646177|141403766|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from PCS.||||<0.001
70951524|NCT01646177|141403766|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from PCS.||||<0.001
70951525|NCT01646177|141403766|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from PCS.||||<0.001
70951526|NCT01646177|141403766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.031|TWO_SIDED||||||ANCOVA|||Includes analysis only from MCS.||||0.031
70951527|NCT01646177|141403766|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from MCS.||||<0.001
70951528|NCT01646177|141403766|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from MCS.||||<0.001
70951529|NCT01646177|141403767|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
70951530|NCT01646177|141403767|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
70951531|NCT01646177|141403767|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
70951532|NCT01646177|141403768|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
70951533|NCT01646177|141403768|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
70951534|NCT01646177|141403768|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
70951535|NCT01646177|141403769|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
70951536|NCT01646177|141403769|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
70951537|NCT01646177|141403769|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
70951538|NCT01646177|141403770|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
70951539|NCT01646177|141403770|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
70951540|NCT01646177|141403770|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
70951541|NCT00402051|141403793|SUPERIORITY_OR_OTHER||6-Month PFS Rate|52.8|||||TWO_SIDED|95.0|40.3|65.3||||||Hypothesis testing was done independently for each treatment arm (no direct treatment group comparison).||65.3|40.3|
70951542|NCT00402051|141403793|SUPERIORITY_OR_OTHER||6-Month PFS Rate|39.3|||||TWO_SIDED|95.0|27.8|50.8||||||Hypothesis testing was done independently for each treatment arm (no direct treatment group comparison).||50.8|27.8|
70951543|NCT00402051|141403795|SUPERIORITY_OR_OTHER||Best Overall Response Rate (%)|32.3||||||95.0|21.2|45.1||||||Response rates were evaluated separately for each treatment arm||45.1|21.2|
70951544|NCT00402051|141403795|SUPERIORITY_OR_OTHER||Best Overall Response Rate (%)|20.0||||||95.0|11.1|31.8||||||Response rates were evaluated separately for each treatment arm||31.8|11.1|
70951545|NCT01791972|141403808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2|STANDARD_ERROR_OF_MEAN|1.982|<|0.0001|TWO_SIDED|95.0|-20.19|-12.14||Significance level is 0.05.|mixed-effect analysis of covariance|Fixed effects of sequence, trt group, period, and center, within period baseline FEV1 as a covariate, and random effect for patient within sequence.||||-12.14|-20.19|<0.0001
70951546|NCT01791972|141403809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|0.53|0.84||Terms for treatment and period, computed with the generalized estimating equations (GEE) algorithm, which adjusts for potential correlation between measurements on the same patient. Significance level of 0.05.|Regression, Logistic|||||0.84|0.53|<0.0001
70951547|NCT00630734|141403814|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||Threshold of significance was P\<0.05.|ANOVA|||Relative change data were compared between SLCO1B1 diplotype groups using one-way ANOVA (with post-hoc Bonferroni tests).||||0.43
70951548|NCT00630734|141403815|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||ANOVA|||||||0.28
70951549|NCT00630734|141403816|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||ANOVA|||||||0.66
70951550|NCT00630734|141403817|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANOVA|||||||0.85
70951551|NCT00630734|141403818|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANOVA|||||||0.11
70951552|NCT00630734|141403819|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||ANOVA|||||||0.15
70951553|NCT00630734|141403820|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANOVA|||||||0.22
70951554|NCT00630734|141403821|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||ANOVA|||||||0.67
70951555|NCT00630734|141403822|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANOVA|||||||0.006
71143265|NCT00416624|141780274|NON_INFERIORITY_OR_EQUIVALENCE|If the hematopoietic response rate in the standard therapy group is far from 50% (\<25% or \>75%), the\> above sample size will provide an 80% power to detect a difference as small as\> 25%.|||||>|0.49|TWO_SIDED||||||Fisher Exact|||With 80 patients per treatment arm, there will be\> about 80% power to detect a difference through Fisher's exact test across two\> treatment arms of 25% in the true percentage of patients that experience a\> hematopoietic response as defined previously, if that percentage is at least 30% in\> the superior group, again with a 1.7% type I error rate.||||>0.49
70951556|NCT00630734|141403823|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANOVA|||||||0.08
70951557|NCT06152224|141403844|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.|Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|4.0||0.918|TWO_SIDED|||||a priori threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline||||0.918
70951558|NCT06152224|141403849|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.801||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline||||0.801
70951559|NCT06152224|141403849|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.317||||||a priori threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline||||0.317
70951560|NCT06152224|141403850|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.|||||<|0.001||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline Brink Score: Pressure||||<0.001
70951561|NCT06152224|141403850|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.|||||<|0.001||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline in Brink Score: Pressure||||<0.001
70951562|NCT06152224|141403851|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.|||||<|0.001||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||Change from baseline in Brink Score: Vertical Displacement||||<0.001
70951563|NCT06152224|141403851|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.|||||<|0.001||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline in Brink Score: Vertical Displacement||||<0.001
71143266|NCT00416624|141780277|NON_INFERIORITY_OR_EQUIVALENCE|If the hematopoietic response rate in the standard therapy group is far from 50% (\<25% or \>75%), the above sample size will provide an 80% power to detect a difference as small as 25%.|||||>|0.56|TWO_SIDED||||||Fisher Exact|||With 80 patients per treatment arm, there will be about 80% power to detect a difference through Fisher's exact test across two treatment arms of 25% in the true percentage of patients that experience a hematopoietic response as defined previously, if that percentage is at least 30% in the superior group, again with a 1.7% type I error rate.||||>0.56
70951564|NCT06152224|141403852|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.|||||<|0.001||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline in Brink Score: Duration Contraction||||<0.001
70951565|NCT06152224|141403852|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.|||||<|0.001||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline in Brink Score: Duration Contraction||||<0.001
70951566|NCT06152224|141403862|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.035||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||Q1. The app was easy to use||||0.035
70951567|NCT06152224|141403862|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.063||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||Q2. It was easy for me to learn to use the app||||0.063
70951568|NCT06152224|141403862|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.587||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||Q11. I would use this app again||||0.587
70951569|NCT06152224|141403862|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.107||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||Q12. Overall, I am satisfied with this app||||0.107
70951570|NCT06152224|141403862|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.486||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||Q15. The app helped me manage my health effectively||||0.486
70951571|NCT02755129|141403875|OTHER||||||||||||||||||"To assess the similarity between the Reveal LINQ measures and those from the reference system, correlation coefficients were used.~The correlation coefficient was calculated over windows of 4 seconds and averaged for each exercise. Then, the average correlation coefficient over all patients and exercise was calculated."|||
70951572|NCT04991753|141403893|SUPERIORITY||Least square mean difference|-0.45|||=|0.224|TWO_SIDED|95.0|-1.17|0.28|||ANCOVA|||||0.28|-1.17|=0.224
70951573|NCT03299049|141403909|NON_INFERIORITY|Non-inferiority was concluded if the upper bound of the two-sided 95% confidence interval (CI) for the Cochran-Mantel Haenzel (CMH) adjusted treatment difference (Q8W minus Q4W) is less than 4%.|Adjusted difference|0.8|||||TWO_SIDED|95.0|-0.6|2.2|||||Adjusted CMH estimate of the difference in the percentage of participants with Plasma HIV-1 \>=50 c/mL between each treatment group (Q8W - Q4W) and corresponding 95% CI is presented.|||2.2|-0.6|
70951574|NCT03299049|141403910|NON_INFERIORITY|Non-inferiority was concluded if the upper bound of the two-sided 95% CI for the CMH adjusted treatment difference (Q8W minus Q4W) is greater than -10%|Adjusted difference|0.8|||||TWO_SIDED|95.0|-2.1|3.7|||||Adjusted CMH estimate of the difference in the percentage of participants with Plasma HIV-1 \<50 c/mL between each treatment group (Q8W-Q4W) and corresponding 95% CI is presented.|||3.7|-2.1|
70951575|NCT01901419|141403957|SUPERIORITY|||||||0.618|||||||t-test, 2 sided|||||||0.618
70951576|NCT01901419|141403958|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.410
70951577|NCT01901419|141403959|SUPERIORITY|||||||0.088|||||||t-test, 2 sided|||||||0.088
70951578|NCT01901419|141403960|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||||||0.320
70868737|NCT01817530|141223642|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
70951579|NCT01901419|141403961|SUPERIORITY|||||||0.512|||||||t-test, 2 sided|||||||0.512
70951580|NCT01901419|141403962|SUPERIORITY|||||||0.144|||||||t-test, 2 sided|||||||0.144
70951581|NCT01901419|141403963|SUPERIORITY|||||||0.338|||||||t-test, 2 sided|||||||0.338
70951582|NCT01901419|141403964|SUPERIORITY|||||||0.356|||||||t-test, 2 sided|||||||0.356
70951583|NCT01901419|141403965|SUPERIORITY|||||||0.478|||||||t-test, 2 sided|||||||0.478
70951584|NCT01901419|141403966|SUPERIORITY|||||||0.515|||||||t-test, 2 sided|||||||0.515
70951585|NCT01901419|141403967|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
70951586|NCT01901419|141403968|SUPERIORITY|||||||0.227|||||||t-test, 2 sided|||||||0.227
70951587|NCT01901419|141403969|SUPERIORITY|||||||0.141|||||||t-test, 2 sided|||||||0.141
70951588|NCT01901419|141403970|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||||||0.046
70951589|NCT01901419|141403971|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.800
70951590|NCT01901419|141403972|SUPERIORITY|||||||0.948|||||||t-test, 2 sided|||||||0.948
70951591|NCT01901419|141403973|SUPERIORITY|||||||0.682|||||||t-test, 2 sided|||||||0.682
70951592|NCT01901419|141403974|SUPERIORITY|||||||0.928|||||||t-test, 2 sided|||||||0.928
70951593|NCT01901419|141403975|SUPERIORITY|||||||0.672|||||||t-test, 2 sided|||||||0.672
70951594|NCT01901419|141403976|SUPERIORITY|||||||0.894|||||||t-test, 2 sided|||||||0.894
70951595|NCT01901419|141403977|SUPERIORITY|||||||0.135|||||||t-test, 2 sided|||||||0.135
70951596|NCT01901419|141403978|SUPERIORITY|||||||0.038|||||||t-test, 2 sided|||||||0.038
70951597|NCT01901419|141403979|SUPERIORITY|||||||0.852|||||||t-test, 2 sided|||||||0.852
70951598|NCT01901419|141403980|SUPERIORITY|||||||0.454|||||||t-test, 2 sided|||||||0.454
70951599|NCT01901419|141403981|SUPERIORITY|||||||0.663|||||||t-test, 2 sided|||||||0.663
70951600|NCT01901419|141403982|SUPERIORITY|||||||0.872|||||||t-test, 2 sided|||||||0.872
70951601|NCT01901419|141403983|SUPERIORITY|||||||0.318|||||||t-test, 2 sided|||||||0.318
70951602|NCT01901419|141403984|SUPERIORITY|||||||0.365|||||||t-test, 2 sided|||||||0.365
70951603|NCT01901419|141403985|SUPERIORITY|||||||0.077|||||||t-test, 2 sided|||||||0.077
70951604|NCT01901419|141403986|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||||||0.640
70951605|NCT04486625|141403991|OTHER|Analysis of variance (ANOVA) was used to compare the natural log transformed AUC0-24,ss between the normal renal function group (Reference) and the severe renal impairment group (Test). The geometric least squares mean point estimate and the associated 90% confidence intervals (CIs) for the difference of each comparison was estimated.|Ratio (%) of adjusted geometric means|79.48|||||TWO_SIDED|90.0|66.52|94.96||||||||94.96|66.52|
70951606|NCT04486625|141403992|OTHER|ANOVA was used to compare the natural log transformed Cmax between the normal renal function group (Reference) and the severe renal impairment group (Test). The geometric least squares mean point estimate and the associated 90% CIs for the difference of each comparison was estimated.|Ratio (%) of adjusted geometric means|75.58|||||TWO_SIDED|90.0|66.1|86.43||||||||86.43|66.10|
70868738|NCT01817530|141223642|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
70868739|NCT01817530|141223642|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
70868740|NCT01817530|141223642|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
70951607|NCT04486625|141403993|OTHER|ANOVA was used to compare the natural log transformed AUC0-24,ss between the normal renal function group (Reference) and the severe renal impairment group (Test). The geometric least squares mean point estimate and the associated 90% CIs for the difference of each comparison was estimated.|Ratio (%) of of adjusted geometric means|124.19|||||TWO_SIDED|90.0|100.18|153.97||||||||153.97|100.18|
70951608|NCT04486625|141403994|OTHER|ANOVA was used to compare the natural log transformed Cmax between the normal renal function group (Reference) and the severe renal impairment group (Test). The geometric least squares mean point estimate and the associated 90% CIs for the difference of each comparison was estimated.|Ratio (%) of adjusted geometric means|102.42|||||TWO_SIDED|90.0|87.55|119.83||||||||119.83|87.55|
70951609|NCT01088984|141404023|SUPERIORITY_OR_OTHER|||||||1||||||1-sided p-value is calculated against the null hypothesis of a response rate of 5%.|binomial parameter exact method|||||||1.0000
70951610|NCT02412735|141404056|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.2072.|||
70951611|NCT02412735|141404056|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.6427.|||
70951612|NCT02412735|141404057|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.2754.|||
70951613|NCT02412735|141404057|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.9087.|||
70951614|NCT02412735|141404058|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.2835.|||
70951615|NCT02412735|141404058|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.4739.|||
70951616|NCT02412735|141404059|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.2650.|||
70951617|NCT02412735|141404059|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.7004.|||
70951618|NCT02412735|141404060|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.1945.|||
70951619|NCT02412735|141404060|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.8093.|||
70868741|NCT01817530|141223642|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
70951620|NCT02412735|141404061|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.7842|TWO_SIDED|95.0|0.5|2.46|||Regression, Cox|P-value was calculated from a Cox regression model with treatment, pooled site, and opioid/non opioid use at Baseline as covariates.|Hazard ratio and 95% confidence interval (CI) were calculated from a Cox regression model with treatment, pooled site, and opioid/non opioid use at Baseline as covariates.|||2.46|0.50|0.7842
70951621|NCT02412735|141404061|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.8754|TWO_SIDED|95.0|0.41|2.14|||Regression, Cox|P-value was calculated from a Cox regression model with treatment, pooled site, and opioid/non opioid use at Baseline as covariates.|Hazard ratio and 95% CI were calculated from a Cox regression model with treatment, pooled site, and opioid/non opioid use at Baseline as covariates.|||2.14|0.41|0.8754
70951622|NCT02412735|141404062|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.2309.|||
70951623|NCT02412735|141404062|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.1241.|||
70951624|NCT02412735|141404063|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|3.08||0.9072|TWO_SIDED|95.0|-5.71|6.43|||Mixed Model for Repeated Measures (MMRM)|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 1||6.43|-5.71|0.9072
70951625|NCT02412735|141404063|SUPERIORITY||Least Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|3.14||0.2883|TWO_SIDED|95.0|-9.51|2.83|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 1||2.83|-9.51|0.2883
70951626|NCT02412735|141404063|SUPERIORITY||Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|3.23||0.6314|TWO_SIDED|95.0|-7.9|4.8|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 3||4.80|-7.90|0.6314
70951627|NCT02412735|141404063|SUPERIORITY||Least Squares Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|3.29||0.1366|TWO_SIDED|95.0|-11.37|1.56|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 3||1.56|-11.37|0.1366
71143267|NCT04673214|141780288|SUPERIORITY|The null hypothesis for the modification in the clinical evolution of the conjunctivitis sign in patients diagnosed with COVID-19 under early intervention treatment with Azithromycin / Ribaroxaban / Paracetamol for 14 days followed by video call is rejected.||||||0.05||||||Presence of a p \<0.05 as significant in the comparison of treatment with clinical symptoms|Chi-squared|||Null Hypothesis: There will be no modification in the clinical evolution ≥ 25% of patients diagnosed with COVID-19 under an early intervention treatment with Azithromycin / Ivermectin / Ribaroxaban / Paracetamol vs. Azithromycin / Ribaroxaban / Paracetamol for 14 days followed by video call from U.M.F 13 and U.M.F 20 from I.M.S.S., during the period of December 2020- February 2021, with a power of 90%, type I error rate 1% and loss to follow-up 20%.||||0.05
70951628|NCT02412735|141404063|SUPERIORITY||Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|3.34||0.2497|TWO_SIDED|95.0|-10.43|2.72|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 6||2.72|-10.43|0.2497
71143268|NCT04673214|141780288|SUPERIORITY|The null hypothesis is rejected with a difference of 2 days in the modification of the clinical evolution (symptoms of fever, cough, headache, myalgia, odynophagia, anosmia, rhinorrhea, arthralgia, chest pain, dyspnea, conjunctivitis) of patients diagnosed with COVID -19 in early intervention treatment. vs. therapeutic failure, for 14 days followed by video call, with a power of 90%, a type I error rate of 1% and a loss to follow-up of 20%||||||0.05|||||||t-test, 2 sided|||Assuming a difference of 2 days in the modification of the clinical course (symptoms of fever, cough, headache, myalgia, odynophagia, anosmia, rhinorrhea, arthralgia, chest pain, dyspnea, conjunctivitis) of patients diagnosed with COVID-19 in early intervention treatment vs. therapeutic failure, for 14 days followed by video call, with a power of 90%, a type I error rate of 1% and a loss to follow-up of the twenty%||||0.05
71143269|NCT04673214|141780289|SUPERIORITY|Assuming a difference in the percentage of effectiveness in the clinical modification and therapeutic failure of patients diagnosed with the outcome of improvement in the Modification of the clinical evolution of the symptoms of patients with COVID-19 using double therapy was reported 95.7% (n = 44) Vs. triple therapy 90.8% (n = 59) and therapeutic failure 4.3% (n = 2) vs. 9.2% (n = 6), respectively.||||||0.05||||||Presence of a p \<0.05 as significant in the comparison of treatment with clinical symptoms the clinical modification and therapeutic failure of patients diagnosed with COVID-19|Chi-squared|||Assuming a difference in the percentage of effectiveness in the clinical modification and therapeutic failure of patients diagnosed with COVID-19 under treatment with Azithromycin / Ivermectin / Ribaroxaban / Paracetamol vs. Azithromycin / Ribaroxaban / Paracetamol followed for 14 days followed by video call, with a power of 90%, a type I error rate of 1% and a loss to follow-up of 20%||||0.05
71143270|NCT04673214|141780290|SUPERIORITY|The null hypothesis is rejected with a mean duration of 2 days with clinical symptoms of COVID-19 in early intervention treatment as a result of improving the modification of the clinical evolution of symptoms vs therapeutic failure.||||||0.05|||||||t-test, 2 sided|||Assuming a difference in days of effectiveness in clinical modification and therapeutic failure of patients diagnosed with COVID-19 in treatment with Azithromycin / Ivermectin / Ribaroxaban / Paracetamol vs. Azithromycin / Ribaroxaban / Paracetamol followed for 14 days followed by video call, with a potency 90%, a Type I error rate of 1%, and a loss to follow-up of 20%||||0.05
71143271|NCT04673214|141780291|SUPERIORITY|A total of 62 patients was calculated, however due to the availability of medication, it was recalculated to 111 patients, that is, 65 cases in the triple therapy group and 46 in the double therapy group would be necessary for the analysis.||||||0.05|||||||Wilcoxon (Gehan) statistical test|||Assuming a 25% efficacy in modifying the clinical course (COVID-19 mild phase symptoms) of patients with COVID-19 under a comparative treatment for 14 days followed by video call, with a power of 90%, type I error rate 1% and loss to follow-up 20%||||0.05
71143272|NCT00141453|141780292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.79||95.0|0.75|1.24|||Regression, Cox|The covariates were urinary albumin:creatinine ratio and serum creatinine at baseline \& regions (Japan/Hong Kong) for the renal composite event rate.||We planned to collect 400 patients to detect 35% risk reduction for renal outcome in olmesartan group with 80% power at 2-sided .05 alpha level. The Cox regression model was applied to estimate the hazard ratios (HR)between treatment groups with 95% confidence intervals for the renal and cardiovascular composite event rate.||1.24|0.75|0.79
71143273|NCT00141453|141780293|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.039||95.0|0.43|0.98|||Regression, Cox|Covariates baseline urinary albumin:creatinine ratio, age and history of cardiovascular disease for cardiovascular composite event rate.||||0.98|0.43|0.039
71143274|NCT03585660|141780319|SUPERIORITY|||||||0.02|||||||bootstrap z-test|The standard error of the difference in accuracy was estimated using nonparametric bootstrap, with B=9999 resamples.||The null hypothesis is that the accuracy of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the accuracy of HM-MRI is greater than the accuracy of mp-MRI.||||0.02
71143275|NCT03585660|141780320|SUPERIORITY|||||||0.08|||||||bootstrap z-test|The standard error of the difference of AUCs was estimated using nonparametric bootstrap, with B=9999 resamples.||The null hypothesis is that the AUCs of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the AUC of HM-MRI is greater than the AUC of mp-MRI.||||0.08
71143276|NCT03585660|141780321|SUPERIORITY|||||||0.97|||||||bootstrap z-test|||The null hypothesis is that the sensitivity of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the sensitivity of HM-MRI is greater than the sensitivity of mp-MRI.||||0.97
71143277|NCT03585660|141780322|SUPERIORITY||||||<|0.01|||||||bootstrap z-test|||The null hypothesis is that the specificity of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the specificity of HM-MRI is greater than the specificity of mp-MRI.||||<0.01
71143278|NCT03585660|141780323|SUPERIORITY|The null hypothesis is that the PPV of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the PPV of HM-MRI is greater than the PPV of mp-MRI.||||||0.06|||||||bootstrap z-test|||||||0.06
71143279|NCT03585660|141780324|SUPERIORITY|The null hypothesis is that the NPV of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the NPV of HM-MRI is greater than the NPV of mp-MRI.||||||0.97|||||||bootstrap z-test|||||||0.97
71143280|NCT05635461|141780327|OTHER||Geometric Mean Ratio|60.13|||||TWO_SIDED|90.0|56.12|64.42|||||Geometric mean ratio was obtained by multiplying 100 with ratio of test (CVN424 tablet fasted) and reference (CVN424 suspension fasted).|||64.42|56.12|
71143281|NCT05635461|141780328|OTHER||Geometric Mean Ratio|60.12|||||TWO_SIDED|90.0|56.12|64.42|||||Geometric mean ratio was obtained by multiplying 100 with ratio of test (CVN424 tablet fasted) and reference (CVN424 suspension fasted).|||64.42|56.12|
71143282|NCT05635461|141780329|OTHER||Geometric Mean Ratio|27.94|||||TWO_SIDED|90.0|25.09|31.13|||||Geometric mean ratio was obtained by multiplying 100 with ratio of test (CVN424 tablet fasted) and reference (CVN424 suspension fasted).|||31.13|25.09|
71143283|NCT05635461|141780330|OTHER||Median Difference (Final Values)|1.04|||<|0.0001|TWO_SIDED|90.0|0.9265|2.247|||ANOVA|||||2.2470|0.9265|<0.0001
71143284|NCT05635461|141780330|OTHER||Median Difference (Final Values)|2.78|||<|0.0001|TWO_SIDED|90.0|2.4475|3.0035|||ANOVA|||||3.0035|2.4475|<0.0001
71143285|NCT05635461|141780331|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0||||||||0.000|0.000|
71143286|NCT05635461|141780331|OTHER||Median Difference (Final Values)|0.25||||0.001|TWO_SIDED|90.0|0.0|0.251|||ANOVA|||||0.2510|0.0000|0.0010
71143287|NCT05635461|141780332|OTHER||Geometric Mean Ratio|161.57|||||TWO_SIDED|90.0|150.96|172.92|||||Geometric mean ratio was obtained by multiplying 100 with ratio of test (CVN424 tablet Fed) and reference (CVN424 tablet fasted).|||172.92|150.96|
71143288|NCT05635461|141780333|OTHER||Geometric Mean Ratio|161.59|||||TWO_SIDED|90.0|150.98|172.95|||||Geometric mean ratio was obtained by multiplying 100 with ratio of test (CVN424 tablet Fed) and reference (CVN424 tablet fasted).|||172.95|150.98|
71143289|NCT05635461|141780334|OTHER||Geometric Mean Ratio|304.19|||||TWO_SIDED|90.0|273.51|338.31|||||Geometric mean ratio was obtained by multiplying 100 with ratio of test (CVN424 tablet Fed) and reference (CVN424 tablet fasted).|||338.31|273.51|
71143290|NCT05635461|141780335|OTHER||Median Difference (Final Values)|0.99||||0.0662|TWO_SIDED|90.0|0.006|1.537|||ANOVA|||||1.5370|0.0060|0.0662
71143291|NCT05635461|141780336|OTHER||Median Difference (Final Values)|0.25||||0.0039|TWO_SIDED|90.0|0.0|0.251|||ANOVA|||||0.2510|0.0000|0.0039
71143292|NCT03137654|141780454|SUPERIORITY|||||||0.0078|||||||Linear Mixed Model|||||||.0078
71143293|NCT03137654|141780458|SUPERIORITY|||||||0.393|||||||ANOVA|||||||0.393
71143294|NCT03137654|141780460|SUPERIORITY|||||||0.0344|||||||ANOVA|||||||.0344
71143295|NCT03137654|141780461|SUPERIORITY|||||||0.0344|||||||ANOVA|||||||.0344
71143296|NCT03137654|141780462|SUPERIORITY|||||||0.0365|||||||ANOVA|||||||0.0365
71143297|NCT03137654|141780463|SUPERIORITY|||||||0.212|||||||ANOVA|||||||.212
71143298|NCT03137654|141780464|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
71143299|NCT03137654|141780465|SUPERIORITY|||||||0.445|||||||ANOVA|||||||.445
71143300|NCT03137654|141780466|SUPERIORITY|||||||0.245|||||||ANOVA|||||||.245
71143301|NCT04890652|141780467|OTHER|single group. The power-related information was estimated by calculating the effect size, specifically partial eta squared.|||||<|0.001|||||||General Linear Model|||||||<0.001
71143302|NCT04890652|141780468|OTHER|Single group. The power-related information was estimated by calculating the effect size, specifically partial eta squared.|||||<|0.001|||||||General Linear Model|||||||<0.001
71143303|NCT00474123|141780476|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Wilcoxon (Mann-Whitney)|||The sample size was determined as 78 patients. Continuous data were presented as means ± SD, or median (interquartile range) when the distribution was non-normal. For qualitative variables, we presented counts and relative frequencies. For between-group comparison we used multiple regression with adjustment for baseline values of the outcome variable (ANCOVA), or Wilcoxon rank-sum test when the variable had a non-normal distribution.||||0.3
71143304|NCT00474123|141780477|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||ANCOVA|||The sample size was determined as 78 patients. Continuous data were presented as means ± SD, or median (interquartile range) when the distribution was non-normal. For qualitative variables, we presented counts and relative frequencies. For between-group comparison we used multiple regression with adjustment for baseline values of the outcome variable (ANCOVA), or Wilcoxon rank-sum test when the variable had a non-normal distribution.||||0.65
71143305|NCT00474123|141780478|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANCOVA|||The sample size was determined as 78 patients. Continuous data were presented as means ± SD, or median (interquartile range) when the distribution was non-normal. For qualitative variables, we presented counts and relative frequencies. For between-group comparison we used multiple regression with adjustment for baseline values of the outcome variable (ANCOVA), or Wilcoxon rank-sum test when the variable had a non-normal distribution.||||0.02
71143306|NCT00474123|141780479|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANCOVA|||The sample size was determined as 78 patients. Continuous data were presented as means ± SD, or median (interquartile range) when the distribution was non-normal. For qualitative variables, we presented counts and relative frequencies. For between-group comparison we used multiple regression with adjustment for baseline values of the outcome variable (ANCOVA), or Wilcoxon rank-sum test when the variable had a non-normal distribution.||||0.85
71143307|NCT00659061|141780507|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||at baseline|Chi-squared|||||||0.32
71143308|NCT00659061|141780507|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||at endline|Chi-squared|||||||<0.001
71143309|NCT00659061|141780509|SUPERIORITY_OR_OTHER||||||<|0||95.0|||||ANOVA|adjusted for baseline, child age, sex, number of sprinkles sachets consumed, number of mths between enrollment and endline Hb measurement)||||||<0.000
71143310|NCT00659061|141780510|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||baseline|Chi-squared|||||||0.34
71143311|NCT00659061|141780510|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||endline|Chi-squared|||||||<0.001
71143312|NCT00659061|141780511|SUPERIORITY_OR_OTHER|||||||0||95.0||||endline|ANOVA|adjusted for baseline child age, sex, # of sprinkle sachet consumed, # of mths between enrollment and endline Hb measurement||||||0.000
71143313|NCT00659061|141780512|SUPERIORITY_OR_OTHER|||||||0.7||95.0||||baseline|Chi-squared|||||||0.7
71143314|NCT00659061|141780512|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||endline|Chi-squared|||||||0.02
71143315|NCT00659061|141780513|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||baseline|Chi-squared|||||||0.62
71143316|NCT00659061|141780513|SUPERIORITY_OR_OTHER|||||||0.89||95.0||||endline|Chi-squared|||||||0.89
71143317|NCT00659061|141780514|SUPERIORITY_OR_OTHER|||||||0.93||95.0||||baseline|Chi-squared|||||||0.93
71143318|NCT00659061|141780514|SUPERIORITY_OR_OTHER|||||||0.49||95.0||||endline|Chi-squared|||||||0.49
70868742|NCT01817530|141223642|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
70868743|NCT01817530|141223642|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
70868744|NCT01817530|141223642|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
70868745|NCT01817530|141223643|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
70868746|NCT01817530|141223643|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
71143319|NCT03748823|141780535|NON_INFERIORITY|Noninferiority was determined based on the 90% Confidence interval calculated from the combination z-score that accounts for the interim analysis.|Ratio of Geometric Least Squares Mean|1.257|||<|0.0001|TWO_SIDED|90.0|1.16|1.361||Analysis of variance (ANOVA) was performed on log-transformed Ctrough and included treatment and stratified weight group as fixed effects.|ANOVA||Geometric least squares mean are the least squares mean from the mixed model after back transformation to the original scale. The 90% confidence interval is presented after back transformation to the original scale.|||1.361|1.160|<0.0001
70868747|NCT01817530|141223643|SUPERIORITY|||||||0.02||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.020
70951629|NCT02412735|141404063|SUPERIORITY||Least Squares Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|3.42||0.0666|TWO_SIDED|95.0|-13.0|0.43|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 6||0.43|-13.00|0.0666
70951630|NCT02412735|141404063|SUPERIORITY||Least Squares Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|3.4||0.2147|TWO_SIDED|95.0|-10.91|2.46|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 12||2.46|-10.91|0.2147
70951631|NCT02412735|141404063|SUPERIORITY||Least Squares Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|3.47||0.0162|TWO_SIDED|95.0|-15.19|-1.55|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 12||-1.55|-15.19|0.0162
71143320|NCT01650558|141780566|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.27|||<=|0.05|TWO_SIDED|95.0|0.89|1.82||P-Value is not adjusted for multiple comparisons.|Poisson|Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.||||1.82|0.89|<=0.05
71143321|NCT01650558|141780566|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.28|||<=|0.05|TWO_SIDED|95.0|0.89|1.83||P-Value is not adjusted for multiple comparisons.|Poisson|Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.||||1.83|0.89|<=0.05
71143322|NCT01650558|141780567|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.38|||<=|0.05|TWO_SIDED|95.0|0.83|2.3||No adjustment for multiple comparisons was made.|Fisher Exact|||||2.30|0.83|<=0.05
71143323|NCT01650558|141780567|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.51|||<=|0.05|TWO_SIDED|95.0|0.91|2.49||No adjustment for multiple comparisons was made.|Fisher Exact|||||2.49|0.91|<=0.05
71143324|NCT01650558|141780568|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.13|||<=|0.05|TWO_SIDED|95.0|0.66|1.93||No adjustments for multiple comparisons were made.|Fisher Exact|||||1.93|0.66|<=0.05
71143325|NCT01650558|141780568|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|0.96|||<=|0.05|TWO_SIDED|95.0|0.55|1.68||No adjustments for multiple comparisons were made.|Fisher Exact|||||1.68|0.55|<=0.05
71143326|NCT01650558|141780569|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.47|||<=|0.05|TWO_SIDED|95.0|1.07|2.0||No adjustments for multiple comparisons were made.|Poisson|Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.||||2.00|1.07|<=0.05
71143327|NCT01650558|141780569|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.43|||<=|0.05|TWO_SIDED|95.0|1.04|1.96||No adjustments for multiple comparisons were made.|Poisson|Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.||||1.96|1.04|<=0.05
70951632|NCT02412735|141404063|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|3.67||0.223|TWO_SIDED|95.0|-11.69|2.74|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 18||2.74|-11.69|0.2230
71143328|NCT01650558|141780570|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.31|||<=|0.05|TWO_SIDED|95.0|1.11|1.55||No adjustments for multiple comparisons were made.|Poisson|Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.||||1.55|1.11|<=0.05
71143329|NCT01650558|141780570|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.34|||<=|0.05|TWO_SIDED|95.0|1.14|1.58||No adjustments for multiple comparisons were made.|Poisson|Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.||||1.58|1.14|<=0.05
71143330|NCT02732600|141780574|SUPERIORITY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.59||0.39|TWO_SIDED|95.0|-0.66|1.68|||t-test, 2 sided|||Analysis 1 is Comparison Across Conditions at BASELINE Analysis 2 is Comparison Across Conditions at 6 Months Analysis 3 is Comparison Across Conditions at 1 year||1.68|-0.66|0.39
71143331|NCT02732600|141780574|SUPERIORITY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.71||0.35|TWO_SIDED|95.0|-0.75|2.06|||t-test, 2 sided|||Analysis 1 is Comparison Across Conditions at BASELINE Analysis 2 is Comparison Across Conditions at 6 Months Analysis 3 is Comparison Across Conditions at 1 year||2.06|-0.75|0.35
71143332|NCT02732600|141780574|SUPERIORITY||Mean Difference (Final Values)|1.01|STANDARD_ERROR_OF_MEAN|0.81||0.21|TWO_SIDED|95.0|-0.57|2.6|||t-test, 2 sided|||Analysis 1 is Comparison Across Conditions at BASELINE Analysis 2 is Comparison Across Conditions at 6 Months Analysis 3 is Comparison Across Conditions at 1 year||2.60|-0.57|0.21
71143333|NCT02732600|141780575|SUPERIORITY||Mean Difference (Final Values)|5.61|STANDARD_ERROR_OF_MEAN|3.6||0.156|TWO_SIDED|95.0|-2.2|13.48|||t-test, 2 sided|||t-test used to compare group differences in Cohesiveness at BASELINE||13.48|-2.2|0.156
71143334|NCT02732600|141780575|SUPERIORITY||Mean Difference (Final Values)|7.97|STANDARD_ERROR_OF_MEAN|5.89||0.182|TWO_SIDED|95.0|-3.85|19.8|||t-test, 2 sided|||t-test to compare group means on Communication at BASELINE||19.8|-3.85|0.182
71143335|NCT02732600|141780575|SUPERIORITY||Mean Difference (Final Values)|8.41|STANDARD_ERROR_OF_MEAN|6.31||0.234|TWO_SIDED|95.0|-5.74|22.57|||t-test, 2 sided|||t-test to compare group differences on Role Clarity at BASELINE||22.57|-5.74|0.234
71143336|NCT02732600|141780575|SUPERIORITY||Mean Difference (Final Values)|14.14|STANDARD_ERROR_OF_MEAN|9.63||0.149|TWO_SIDED|95.0|-5.22|33.5|||t-test, 2 sided|||t-test to compare group values on Goals at Baseline||33.5|-5.22|0.149
71143337|NCT02732600|141780575|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|7.1||0.947|TWO_SIDED|95.0|-14.7|13.8|||t-test, 2 sided|||t-test of differences between groups on Cohesiveness at 6-Months||13.8|-14.7|0.947
71143338|NCT02732600|141780575|SUPERIORITY||Mean Difference (Final Values)|1.38|STANDARD_ERROR_OF_MEAN|8.4||0.87|TWO_SIDED|95.0|-15.6|18.4|||t-test, 2 sided|||t-test of groups differences on Communication at 6 Months||18.4|-15.6|0.870
71143339|NCT02732600|141780575|SUPERIORITY||Mean Difference (Final Values)|6.18|STANDARD_ERROR_OF_MEAN|8.62||0.478|TWO_SIDED|95.0|-11.26|23.63|||t-test, 2 sided|||t-test of group differences on Role Clarity at 6 months||23.63|-11.26|0.478
71143340|NCT02732600|141780575|SUPERIORITY||Mean Difference (Final Values)|2.23|STANDARD_ERROR_OF_MEAN|7.71||0.773|TWO_SIDED|95.0|-13.35|17.83|||t-test, 2 sided|||t-test of group differences on Goals at 6 Months||17.83|-13.35|0.773
71143341|NCT02732600|141780575|SUPERIORITY||Mean Difference (Final Values)|9.09|STANDARD_ERROR_OF_MEAN|9.8||0.498|TWO_SIDED|95.0|-20.4|38.6|||t-test, 2 sided|||t-test of group differences on Cohesiveness at 1year||38.6|-20.4|0.498
71143342|NCT02732600|141780575|SUPERIORITY||Mean Difference (Final Values)|3.21|STANDARD_ERROR_OF_MEAN|11.4||0.78|TWO_SIDED|95.0|-20.3|26.7|||t-test, 2 sided|||t-test of group differences on Communication at 1 year||26.7|-20.3|0.780
71143343|NCT02732600|141780575|SUPERIORITY||Mean Difference (Final Values)|11.46|STANDARD_ERROR_OF_MEAN|12.54||0.474|TWO_SIDED|95.0|-23.19|46.11|||t-test, 2 sided|||t-test of group differences on Role Clarity at 1 year||46.11|-23.19|0.474
71143344|NCT02732600|141780575|SUPERIORITY||Mean Difference (Final Values)|10.0|STANDARD_ERROR_OF_MEAN|8.78||0.267|TWO_SIDED|95.0|-8.21|28.21|||t-test, 2 sided|||t-test of group differences on Goals at 1 year||28.21|-8.21|0.267
71143345|NCT02732600|141780576|SUPERIORITY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.38||0.098|TWO_SIDED|95.0|-0.09|1.0|||t-test, 2 sided|||t test comparison across groups on CORE PEER at 6 months||1.00|-0.09|0.098
71143346|NCT02732600|141780576|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|1.1||0.282|TWO_SIDED|95.0|-0.43|1.43|||t-test, 2 sided|||t-test comparison across groups on COLLABORATION at 6 months||1.43|-0.43|0.282
71143347|NCT02732600|141780576|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|0.56||0.06|TWO_SIDED|95.0|-0.05|2.29|||t-test, 2 sided|||t-test comparison across groups on PEER SPECIALIST AS LIAISON at 6 months||2.29|-0.05|0.06
71143348|NCT02732600|141780576|SUPERIORITY||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.86||0.34|TWO_SIDED|95.0|0.07|1.59|||t-test, 2 sided|||t-test comparison across groups on PROVIDES INFO ON SERVICES at 6 months||1.59|0.07|0.34
71143349|NCT02732600|141780576|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.34|TWO_SIDED|95.0|-0.94|2.62|||t-test, 2 sided|||t-test comparison across groups on Symptoms and Medication at 6-months||2.62|-0.94|0.34
71143350|NCT02732600|141780576|SUPERIORITY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.64||0.66|TWO_SIDED|95.0|-1.03|1.5|||t-test, 2 sided|||t-test comparison across groups on Training and Preparation at 6-months||1.50|-1.03|0.66
70868748|NCT01817530|141223643|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
70868749|NCT01817530|141223643|SUPERIORITY|||||||0.002||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.002
70951633|NCT02412735|141404063|SUPERIORITY||Least Squares Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|3.74||0.1152|TWO_SIDED|95.0|-13.27|1.45|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 18||1.45|-13.27|0.1152
71143351|NCT02732600|141780576|SUPERIORITY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.61||0.15|TWO_SIDED|95.0|-0.36|2.16|||t-test, 2 sided|||t-test comparison across groups on Team Integration and Relationships at 6 Months||2.16|-0.36|0.15
71143352|NCT02732600|141780576|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.39||0.59|TWO_SIDED|95.0|-1.01|0.59|||t-test, 2 sided|||t-test comparison across groups on Leadership at 6-months||0.59|-1.01|0.59
71143353|NCT02732600|141780576|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.84||0.95|TWO_SIDED|95.0|-1.77|1.68|||t-test, 2 sided|||t-test comparison across groups on Fits to Experience at 6 months||1.68|-1.77|0.95
71143354|NCT02732600|141780576|SUPERIORITY||Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|0.55||0.32|TWO_SIDED|95.0|-0.58|1.68|||t-test, 2 sided|||t-test comparison across groups on Role Clarity at 6 months||1.68|-0.58|0.32
71143355|NCT02732600|141780576|SUPERIORITY||Mean Difference (Final Values)|0.72|STANDARD_ERROR_OF_MEAN|0.64||0.27|TWO_SIDED|95.0|-0.6|2.04|||t-test, 2 sided|||t-test comparison across both groups on Resources at 6 months||2.04|-0.60|0.27
71143356|NCT02732600|141780576|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.86||0.93|TWO_SIDED|95.0|-1.71|1.85|||t-test, 2 sided|||t-test comparison across groups on Performance Reviews at 6 months||1.85|-1.71|0.93
71143357|NCT02732600|141780576|SUPERIORITY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.32||0.15|TWO_SIDED|95.0|-1.45|-0.005|||t-test, 2 sided|||t-test comparison across groups on CORE PEER at 1 year||-0.005|-1.45|0.15
71143358|NCT02732600|141780576|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.45||0.04|TWO_SIDED|95.0|-1.7|0.32|||t-test, 2 sided|||t-test comparison across groups on Collaboration at 1 year||0.32|-1.7|0.04
71143359|NCT02732600|141780576|SUPERIORITY||Hazard Ratio, log|-0.95|STANDARD_ERROR_OF_MEAN|0.5||0.08|TWO_SIDED|95.0|-2.07|0.17|||t-test, 2 sided|||t-test comparison across groups on Peer Specialists as Liaison at 1 year||0.17|-2.07|0.08
71143360|NCT02732600|141780576|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.39||0.26|TWO_SIDED|95.0|-0.58|0.18|||t-test, 2 sided|||t-test comparison across groups on Provides Info on Services at 1 year||0.18|-0.58|0.26
71143361|NCT02732600|141780576|SUPERIORITY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|1.65||0.61|TWO_SIDED|95.0|-4.53|2.83|||t-test, 2 sided|||t-test comparison between groups on Symptoms and Medication at 1 year||2.83|-4.53|0.61
71143362|NCT02732600|141780576|SUPERIORITY||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.87||0.3|TWO_SIDED|95.0|-2.87|1.01|||t-test, 2 sided|||t-test comparison across groups on Training and Preparation at 1 year||1.01|-2.87|0.30
71143363|NCT02732600|141780576|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.35||0.004|TWO_SIDED|95.0|-2.08|-0.52|||t-test, 2 sided|||t-test comparison across groups on Team Integration and Relationships at 1 year||-0.52|-2.08|0.004
71143364|NCT02732600|141780576|SUPERIORITY||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|0.81||0.01|TWO_SIDED|95.0|-4.2|-0.6|||t-test, 2 sided|||t-test comparison across groups on Leadership at 1 year||-0.60|-4.20|0.01
71143365|NCT02732600|141780576|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.9||0.9|TWO_SIDED|95.0|-24.1|23.5|||t-test, 2 sided|||t-test comparison across groups on Fits to Experience at 1 year||23.5|-24.1|0.90
71143366|NCT02732600|141780576|SUPERIORITY||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|0.7||0.06|TWO_SIDED|95.0|-3.02|0.12|||t-test, 2 sided|||t-test comparison across groups on Role Clarity at 1 year||0.12|-3.02|0.06
71143367|NCT02732600|141780576|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.53||0.71|TWO_SIDED|95.0|-0.97|1.37|||t-test, 2 sided|||t-test comparison across groups on Resources at 1 year||1.37|-0.97|0.71
71143368|NCT02732600|141780576|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.63||0.41|TWO_SIDED|95.0|-5.03|2.23|||t-test, 2 sided|||t-test comparison on Performance Reviews at 1 year||2.23|-5.03|0.41
71143369|NCT02732600|141780577|SUPERIORITY||Mean Difference (Final Values)|3.59|STANDARD_ERROR_OF_MEAN|1.17||0.002|TWO_SIDED|95.0|1.29|5.88||not adjusted for multiple comparisons|t-test, 2 sided|||Group Comparison at Baseline||5.88|1.29|0.002
71143370|NCT02732600|141780577|SUPERIORITY||Mean Difference (Final Values)|2.62|STANDARD_ERROR_OF_MEAN|1.6||0.1|TWO_SIDED|95.0|-0.54|5.78|||t-test, 2 sided|||Group Comparison at 6 Months||5.78|-0.54|0.10
71143371|NCT02732600|141780577|SUPERIORITY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|1.83||0.77|TWO_SIDED|95.0|-3.06|4.14|||t-test, 2 sided|||Group Comparison at 1 year||4.14|-3.06|0.77
71143372|NCT02732600|141780578|SUPERIORITY||Mean Difference (Final Values)|3.47|STANDARD_ERROR_OF_MEAN|1.56||0.02|TWO_SIDED|95.0|0.56|6.38||p value for 1st year only|t-test, 2 sided|||||6.38|0.56|0.02
71143373|NCT02732600|141780578|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|2.39||0.93|TWO_SIDED|95.0|-4.67|5.04|||t-test, 2 sided|||||5.04|-4.67|0.93
71143374|NCT02732600|141780579|SUPERIORITY||Mean Difference (Final Values)|1.02|STANDARD_ERROR_OF_MEAN|0.2||0.0001|TWO_SIDED|95.0|0.68|1.37|||t-test, 2 sided|p value for 1st year||||1.37|0.68|0.0001
71143375|NCT02732600|141780580|SUPERIORITY||Mean Difference (Final Values)|5.7|STANDARD_ERROR_OF_MEAN|2.26||0.02|TWO_SIDED|95.0|1.46|9.96|||t-test, 2 sided|||||9.96|1.46|0.02
71143376|NCT02732600|141780580|SUPERIORITY||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|2.92||0.38|TWO_SIDED|95.0|-3.14|8.54|||t-test, 2 sided|||||8.54|-3.14|0.38
71143377|NCT02732600|141780581|SUPERIORITY||Mean Difference (Final Values)|-99.4|STANDARD_ERROR_OF_MEAN|41.73||0.027|TWO_SIDED|95.0|-186.2|-12.66|||t-test, 2 sided|||||-12.66|-186.2|0.027
70868750|NCT01817530|141223643|SUPERIORITY|||||||0.061||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.061
70868751|NCT01817530|141223643|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
70868752|NCT01817530|141223643|SUPERIORITY|||||||0.004||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.004
70868753|NCT01817530|141223643|SUPERIORITY|||||||0.085||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.085
70868754|NCT01817530|141223643|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
70868755|NCT01817530|141223643|SUPERIORITY|||||||0.012||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.012
70868756|NCT01817530|141223643|SUPERIORITY|||||||0.049||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.049
70951634|NCT02412735|141404063|SUPERIORITY||Least Squares Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|3.66||0.4884|TWO_SIDED|95.0|-9.75|4.67|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 24||4.67|-9.75|0.4884
71143378|NCT02732600|141780582|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.18||0.001|TWO_SIDED|95.0|0.28|0.92|||t-test, 2 sided|||||0.92|0.28|0.001
70868757|NCT01817530|141223643|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
70868758|NCT01817530|141223643|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
70868759|NCT01817530|141223643|SUPERIORITY|||||||0.056||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.056
70868760|NCT01817530|141223643|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
70868761|NCT01817530|141223643|SUPERIORITY|||||||0.005||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.005
70868762|NCT01817530|141223643|SUPERIORITY|||||||0.088||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.088
70868763|NCT01817530|141223644|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
70868764|NCT01817530|141223644|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
70868765|NCT01817530|141223644|SUPERIORITY|||||||0.188||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.188
70868766|NCT01817530|141223644|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
70868767|NCT01817530|141223644|SUPERIORITY|||||||0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.001
70868768|NCT01817530|141223644|SUPERIORITY|||||||0.104||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.104
70868769|NCT01817530|141223644|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
70868770|NCT01817530|141223644|SUPERIORITY|||||||0.021||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.021
70868771|NCT01817530|141223644|SUPERIORITY|||||||0.859||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.859
70868772|NCT01817530|141223644|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
70868773|NCT01817530|141223644|SUPERIORITY|||||||0.006||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.006
70951635|NCT02412735|141404063|SUPERIORITY||Least Squares Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|3.74||0.0426|TWO_SIDED|95.0|-14.98|-0.25|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 24||-0.25|-14.98|0.0426
70951636|NCT02412735|141404063|SUPERIORITY||Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|3.77||0.3056|TWO_SIDED|95.0|-11.27|3.54|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 36||3.54|-11.27|0.3056
70951637|NCT02412735|141404063|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|3.85||0.1184|TWO_SIDED|95.0|-13.59|1.54|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 36||1.54|-13.59|0.1184
70951638|NCT01757197|141404068|OTHER|Not evaluable.|Other|0.0|||||TWO_SIDED|||||Not evaluable.||||Not evaluable.|Not evaluable.|||
70951639|NCT00874731|141404124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48|||||TWO_SIDED|90.0|-2.8|3.76|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|3.76|-2.80|
70951640|NCT00874731|141404127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||||TWO_SIDED|95.0|-3.83|2.74|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|2.74|-3.83|
71143379|NCT00528957|141780583|NON_INFERIORITY_OR_EQUIVALENCE|In the randomized phase, it was assumed that the respective proportions of participants maintaining HIV-1 RNA \< 400 copies/mL was 92% for participants switching to tenofovir DF and 90% for participants continuing stavudine or zidovudine, as estimated from previous GSI studies. The equivalence limit was set at -15% for the lower boundary of a two-sided 95% confidence interval (CI) on the difference in proportions of participants maintaining HIV-1 RNA \< 400 copies/mL at Week 48.|Difference in percentages between groups|-8.5|||||TWO_SIDED|95.0|-21.5|4.5|||Normal approximation|The difference between the two proportions and its CI were based on normal approximation methods.|Difference is for tenofovir DF minus stavudine or zidovudine (randomized phase)|"The statistical hypotheses for the primary endpoint was as follows:~* Null Hypothesis: tenofovir DF group is more than 15% worse than the stavudine or zidovudine group with respect to the proportion of participants maintaining HIV-1 RNA concentrations \< 400 copies/mL at Week 48.~* Alternate Hypothesis: tenofovir DF group is no more than 15% worse than the stavudine or zidovudine group with respect to the proportion of participants maintaining HIV-1 RNA \< 400 copies/mL at Week 48."||4.5|-21.5|
70868774|NCT01817530|141223644|SUPERIORITY|||||||0.015||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.015
70951641|NCT00874731|141404128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18|||||TWO_SIDED|95.0|-4.5|2.14|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|2.14|-4.50|
70868775|NCT01817530|141223644|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
70868776|NCT01817530|141223644|SUPERIORITY|||||||0.007||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.007
71143380|NCT00528957|141780584|NON_INFERIORITY|In the randomized phase, it was assumed that the respective proportions of participants maintaining HIV-1 RNA \< 400 copies/mL was 92% for subjects switching to tenofovir DF and 90% for subjects continuing stavudine or zidovudine, as estimated from previous GSI studies. The equivalence limit was set at -15% for the lower boundary of a two-sided 95% confidence interval (CI) on the difference in proportions of participants maintaining HIV-1 RNA \< 400 copies/mL at Week 48.|Difference in percentages between groups|-0.9|||||TWO_SIDED|95.0|-13.7|11.8|||||The difference between the two proportions and its CI were based on normal approximation methods.|||11.8|-13.7|
70868777|NCT01817530|141223644|SUPERIORITY|||||||0.722||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.722
70868778|NCT01817530|141223644|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
70868779|NCT01817530|141223644|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
70868780|NCT01817530|141223644|SUPERIORITY|||||||0.032||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.032
70868781|NCT01817530|141223645|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
70868782|NCT01817530|141223645|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
71143381|NCT03284710|141780655|OTHER|||||||0.358||||||The threshold for statistical significance was p = 0.05.|Barnard's test|||IgGAb binding to 1086C\_D7gp120.avi/293F in Group 1 versus Group 2||||0.358
71143382|NCT03284710|141780655|OTHER|||||||1||||||The threshold for statistical significance was p = 0.05.|Barnard's test|||IgGAb binding to 96ZM651.D11gp120.avi in Group 1 versus Group 2||||1.000
71143383|NCT03284710|141780655|OTHER|||||||0.361||||||The threshold for statistical significance was p = 0.05.|Barnard's test|||IgGAb binding to TV1c8\_D11gp120.avi/293F in Group 1 versus Group 2||||0.361
71143384|NCT03284710|141780656|OTHER|||||||0.238||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||IgGAb binding to 1086C\_D7gp120.avi/293F in Group 1 versus Group 2||||0.238
71143385|NCT03284710|141780656|OTHER|||||||0.893||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||IgGAb binding to 96ZM651.D11gp120.avi in Group 1 versus Group 2||||0.893
71143386|NCT03284710|141780656|OTHER|||||||0.411||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||IgGAb binding to TV1c8\_D11gp120.avi/293F in Group 1 versus Group 2||||0.411
71143387|NCT03284710|141780657|OTHER|||||||1||||||The threshold for statistical significance was p = 0.05.|Barnard's test|||IgAAb binding to 1086C\_D7gp120.avi/293F in Group 1 versus Group 3||||1.000
71143388|NCT03284710|141780657|OTHER|||||||0.044||||||The threshold for statistical significance was p = 0.05.|Barnard's test|||IgAAb binding to 96ZM651.D11gp120.avi in Group 1 versus Group 3||||0.044
71143389|NCT03284710|141780657|OTHER|||||||0.045||||||The threshold for statistical significance was p = 0.05.|Barnard's test|||IgAAb binding to TV1c8\_D11gp120.avi/293F in Group 1 versus Group 3||||0.045
71143390|NCT03284710|141780658|OTHER|||||||0.215||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||IgAAb binding to 1086C\_D7gp120.avi/293F in Group 1 versus Group 3||||0.215
71143391|NCT03284710|141780658|OTHER|||||||0.683||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||IgAAb binding to 96ZM651.D11gp120.avi in Group 1 versus Group 3||||0.683
71143392|NCT03284710|141780658|OTHER|||||||0.322||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||IgAAb binding to TV1c8\_D11gp120.avi/293F in Group 1 versus Group 3||||0.322
71143393|NCT01706458|141780740|OTHER|||||||0.906|||||||Log Rank|||||||0.9060
71143394|NCT00072462|141780750|SUPERIORITY||Hazard Ratio (HR)|0.88|STANDARD_DEVIATION|0.12||0.33|TWO_SIDED|95.0|0.67|1.14|||Regression, Cox|Univariate||||1.14|0.67|0.33
71143395|NCT00072462|141780750|SUPERIORITY||Hazard Ratio (HR)|0.87|STANDARD_DEVIATION|0.12||0.33|TWO_SIDED|95.0|0.66|1.15|||Regression, Cox|Covariates included in model: Hormone Replacement Therapy use, Age, BMI, Use of radiotherapy, Extent of margins, Grade(categorical: low, medium, high)||||1.15|0.66|0.33
71143396|NCT00072462|141780751|SUPERIORITY||Hazard Ratio (HR)|0.72|STANDARD_DEVIATION|0.12||0.06|TWO_SIDED|95.0|0.52|1.01|||Regression, Cox|Univariate||||1.01|0.52|0.06
71143397|NCT00072462|141780751|SUPERIORITY||Hazard Ratio (HR)|0.74|STANDARD_DEVIATION|0.13||0.09|TWO_SIDED|95.0|0.52|1.05|||Regression, Cox|Covariates included in model: Hormone Replacement Therapy use, Age, BMI, Use of radiotherapy, Extent of margins, Grade(categorical: low, medium, high)||||1.05|0.52|0.09
71143398|NCT00072462|141780752|SUPERIORITY||Hazard Ratio (HR)|1.64|STANDARD_DEVIATION|0.54||0.13|TWO_SIDED|95.0|0.75|2.84|||Regression, Cox|Univariate||||2.84|0.75|0.13
71143399|NCT00072462|141780752|SUPERIORITY||Hazard Ratio (HR)|1.46|STANDARD_DEVIATION|0.5||0.26|TWO_SIDED|95.0|0.75|2.84|||Regression, Cox|Covariates included in model: Hormone Replacement Therapy use, Age, BMI, Use of radiotherapy, Extent of margins, Grade(categorical: low, medium, high)||||2.84|0.75|0.26
71143400|NCT00072462|141780753|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.97|TWO_SIDED|95.0|0.21|5.11|||Regression, Cox|Univariate||||5.11|0.21|0.97
70868783|NCT01817530|141223645|SUPERIORITY|||||||0.041||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.041
70868784|NCT01817530|141223645|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
70868785|NCT01817530|141223645|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
70868786|NCT01817530|141223645|SUPERIORITY|||||||0.008||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.008
70868787|NCT01817530|141223645|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
70868788|NCT01817530|141223645|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
70868789|NCT01817530|141223645|SUPERIORITY|||||||0.003||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.003
70868790|NCT01817530|141223645|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
70868791|NCT01817530|141223645|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
70868792|NCT01817530|141223645|SUPERIORITY|||||||0.003||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.003
71143401|NCT00072462|141780753|SUPERIORITY||Hazard Ratio (HR)|1.08|STANDARD_DEVIATION|0.88||0.93|TWO_SIDED|95.0|0.22|5.36|||Regression, Cox|Covariates included in model: Hormone Replacement Therapy use, Age, BMI, Use of radiotherapy, Extent of margins, Grade(categorical: low, medium, high)||||5.36|0.22|0.93
70868793|NCT01817530|141223645|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
70868794|NCT01817530|141223645|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
70868795|NCT01817530|141223645|SUPERIORITY|||||||0.004||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.004
70868796|NCT01817530|141223645|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
70868797|NCT01817530|141223645|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
70868798|NCT01817530|141223645|SUPERIORITY|||||||0.002||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.002
71143402|NCT00072462|141780754|SUPERIORITY||Hazard Ratio (HR)|0.93|STANDARD_DEVIATION|0.17||0.67|TWO_SIDED|95.0|0.65|1.32|||Regression, Cox|Univariate||||1.32|0.65|0.67
71143403|NCT00072462|141780754|SUPERIORITY||Hazard Ratio (HR)|0.85|STANDARD_DEVIATION|0.16||0.38|TWO_SIDED|95.0|0.59|1.22|||Regression, Cox|Covariates included in model: Hormone Replacement Therapy use, Age, BMI, Use of radiotherapy, Extent of margins, Grade(categorical: low, medium, high)||||1.22|0.59|0.38
71143404|NCT02927301|141780761|SUPERIORITY||Other/Percentage|20.3|||<|0.0001|ONE_SIDED|95.0|14.9||||binomial test||||||14.900|<.0001
71143405|NCT02927301|141780762|SUPERIORITY||Risk Difference (RD)|11.41||||0.0358|ONE_SIDED|80.0|5.279||||Fisher Exact||||||5.279|0.0358
71143406|NCT02927301|141780763|SUPERIORITY||Risk Difference (RD)|16.363||||0.0395|ONE_SIDED|80.0|6.509||||Chi-squared||||||6.509|0.0395
71143407|NCT03562195|141780790|SUPERIORITY||Posterior probablity|0.9999|||||||||||Bayesian Dynamic Borrowing|A BDB approach was used in the estimation of primary endpoint in the Chinese participants of this study, with information borrowed from MEA115588.|"Pr (rate ratio \<1 \| data)\>0.999. The 'positive result' is defined as if the posterior probability that the rate ratio is less than 1 is at least 0.95"|||||
71143408|NCT03562195|141780790|SUPERIORITY|The null hypothesis is defined as the rate ratio of events between Mepolizumab 100mg SC versus placebo is less than 1.|Rate Ratio|0.35|||<|0.001|TWO_SIDED|95.0|0.24|0.5|||Negative binomial model|||||0.50|0.24|<0.001
71143409|NCT02646826|141780812|SUPERIORITY|||||||0.0017|||||||ANOVA|||||||0.0017
71143410|NCT02646826|141780813|SUPERIORITY||||||<|0.44|||||||ANOVA|||||||<.44
70868799|NCT01817530|141223646|SUPERIORITY||difference in LS means|-1.5|STANDARD_ERROR_OF_MEAN|2.58||0.556|TWO_SIDED|95.0|-6.65|3.59||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.|ANCOVA|||Final Month||3.59|-6.65|0.556
70868800|NCT01817530|141223646|SUPERIORITY||difference in LS means|-1.1|STANDARD_ERROR_OF_MEAN|2.63||0.672|TWO_SIDED|95.0|-6.33|4.09||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.|ANCOVA|||Final Month||4.09|-6.33|0.672
70868801|NCT01817530|141223646|SUPERIORITY||difference in LS means|3.0|STANDARD_ERROR_OF_MEAN|2.71||0.274|TWO_SIDED|95.0|-2.39|8.36||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.|ANCOVA|||Final Month||8.36|-2.39|0.274
70868802|NCT01817530|141223646|SUPERIORITY||difference in LS means|-2.0|STANDARD_ERROR_OF_MEAN|1.65||0.223|TWO_SIDED|95.0|-5.26|1.23||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.|ANCOVA|||Final Month||1.23|-5.26|0.223
70951642|NCT00874731|141404129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47|||||TWO_SIDED|95.0|-2.85|3.79|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|3.79|-2.85|
71143411|NCT00614575|141780827|SUPERIORITY_OR_OTHER||Mean change from baseline|-7.2|STANDARD_DEVIATION|9.0|<|0.0001|||||||Paired t-test|||||||<0.0001
71143412|NCT00614575|141780828|SUPERIORITY_OR_OTHER||Mean change from baseline|-4.8|STANDARD_DEVIATION|7.8|<|0.0001|||||||Paired t-test|||||||<0.0001
70868803|NCT01817530|141223646|SUPERIORITY||difference in LS means|-2.1|STANDARD_ERROR_OF_MEAN|1.68||0.215|TWO_SIDED|95.0|-5.38|1.22||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.|ANCOVA|||Final Month||1.22|-5.38|0.215
70868804|NCT01817530|141223646|SUPERIORITY||difference in LS means|-1.4|STANDARD_ERROR_OF_MEAN|1.68||0.392|TWO_SIDED|95.0|-4.75|1.87||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.|ANCOVA|||Final Month||1.87|-4.75|0.392
70868805|NCT03846804|141223650|OTHER|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
70868806|NCT00345839|141223663|SUPERIORITY_OR_OTHER_LEGACY|||||||0.112||||||p-value\<0.044 considered significant|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.112
71143413|NCT00614575|141780829|SUPERIORITY_OR_OTHER||Mean change from baseline|-0.7|STANDARD_DEVIATION|0.9|<|0.0001|||||||paired t-test|||||||<0.0001
71143414|NCT00614575|141780830|SUPERIORITY_OR_OTHER||mean change from baseline|-0.3|STANDARD_DEVIATION|0.6|<|0.0001|||||||paired t-test|||||||<0.0001
71143415|NCT04664153|141780835|SUPERIORITY||Mean Difference (Final Values)|-39.4|STANDARD_ERROR_OF_MEAN|11.74||0.0004|TWO_SIDED|90.0|-58.76|-20.12|||t-test, 1 sided|||||-20.12|-58.76|0.0004
71143416|NCT04664153|141780836|SUPERIORITY||Mean Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|1.29|<|0.0001|TWO_SIDED|90.0|-7.02|-2.77|||t-test, 1 sided|||||-2.77|-7.02|<0.0001
71143417|NCT00097500|141780865|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANCOVA|||||||0.0001
71143418|NCT00097500|141780866|SUPERIORITY_OR_OTHER|||||||0.4185||95.0|||||ANCOVA|||||||0.4185
70951643|NCT00874731|141404130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.18|||||TWO_SIDED|95.0|-2.1|4.47|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|4.47|-2.10|
71143419|NCT00097500|141780867|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Statistical analysis at week 52.||||<0.0001
70868807|NCT00345839|141223663|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.85|1.02|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.02|0.85|
71143420|NCT00097500|141780867|SUPERIORITY_OR_OTHER|||||||0.1188||95.0|||||ANCOVA|||Statistical analysis at week 56.||||0.1188
71143421|NCT00097500|141780868|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Statistical analysis at week 52.||||<0.0001
71143422|NCT00097500|141780868|SUPERIORITY_OR_OTHER|||||||0.1996||95.0|||||ANCOVA|||Statistical analysis at week 56.||||0.1996
71143423|NCT00097500|141780869|SUPERIORITY_OR_OTHER|||||||0.5522||95.0|||||ANCOVA|||||||0.5522
71143424|NCT00097500|141780870|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71143425|NCT00097500|141780872|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
70868808|NCT00345839|141223664|SUPERIORITY_OR_OTHER_LEGACY|||||||0.249||||||No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.249
70868809|NCT00345839|141223664|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.85|1.04|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.04|0.85|
70868810|NCT00345839|141223665|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8||||||No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.800
70868811|NCT00345839|141223665|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.79|1.19|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.19|0.79|
70868812|NCT00345839|141223666|SUPERIORITY_OR_OTHER_LEGACY|||||||0.283||||||No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.283
70868813|NCT00345839|141223666|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.58|1.18|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.18|0.58|
70868814|NCT00345839|141223667|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034||||||No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.034
70868815|NCT00345839|141223667|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.68|0.99|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||0.99|0.68|
71143426|NCT00189098|141780890|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-25.0|||||TWO_SIDED|95.0|-44.0|-6.0|||risk differences (RD)||Risk difference and 95% confidence intervals reported for 6 weeks follow-up.|"Assuming a spontaneous recovery of 25% and a treatment effect of TMP-SMX of 50% (based on a retrospective study of children treated with TMP-SMX for COM at our hospital), and taking α=0.05 and a power of 0.80, we calculated that each group should consist of 50 children.~Rate differences with 95% confidence intervals were calculated at the three control visits to compare both groups for the outcome measures."||-6|-44|
71143427|NCT00189098|141780890|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-15.0|||||TWO_SIDED|95.0|-34.0|4.0|||risk difference (RD)||Risk difference and confidence interval reported for 12 week follow-up|"Assuming a spontaneous recovery of 25% and a treatment effect of TMP-SMX of 50% (based on a retrospective study of children treated with TMP-SMX for COM at our hospital), and taking α=0.05 and a power of 0.80, we calculated that each group should consist of 50 children.~Rate differences with 95% confidence intervals were calculated at the three control visits to compare both groups for the outcome measures."||4|-34|
71143428|NCT00189098|141780890|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|-12.0|22.0|||risk difference (RD)||Risk difference and confidence interval reported for 1 year follow-up.|"Assuming a spontaneous recovery of 25% and a treatment effect of TMP-SMX of 50% (based on a retrospective study of children treated with TMP-SMX for COM at our hospital), and taking α=0.05 and a power of 0.80, we calculated that each group should consist of 50 children.~Rate differences with 95% confidence intervals were calculated at the three control visits to compare both groups for the outcome measures."||22|-12|
71143429|NCT00189098|141780891|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-12.0|||||TWO_SIDED|95.0|-34.0|10.0|||rate differences (95%CI intervals)||Risk difference and confidence interval reported for eardrop usage between 6 and 12 weeks follow-up.|||10|-34|
71143430|NCT00189098|141780892|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0|||||TWO_SIDED|95.0|-22.0|14.0|||rate difference (RD)||Risk difference and confidence interval reported for eardrop usage between 12 weeks and 1 year follow-up.|||14|-22|
71143431|NCT00189098|141780893|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-7.0|||||TWO_SIDED|95.0|-23.0|9.0|||Rate differences (95%CI interval)||Risk difference and confidence interval reported for the use of additional systemic antibiotics other than the study medication between 6 to 12 weeks follow-up.|||9|-23|
71143432|NCT00189098|141780894|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.0|||||TWO_SIDED|95.0|-7.0|37.0|||Rate difference (RD)||Risk difference and confidence interval reported for the use of additional systemic antibiotics other than the study medication between 12 weeks and 1 year follow-up.|||37|-7|
71143433|NCT00189098|141780895|SUPERIORITY_OR_OTHER||Risk Difference (RD)|6.0|||||TWO_SIDED|95.0|-12.0|24.0|||Rate differences (95%CI intervals)||Risk difference and confidence interval reported for participants who underwent Ear Nose and Throat Surgery between 12 weeks and 1 year follow-up.|||24|-12|
71143434|NCT01009060|141780918|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.049||||0.7239|TWO_SIDED|90.0|-0.288|0.19|||Mixed Model Repeated Measure|||Week 1||0.190|-0.288|0.7239
71143435|NCT01009060|141780918|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.018||||0.8351|TWO_SIDED|90.0|-0.127|0.163|||Mixed Model Repeated Measure|||Week 2||0.163|-0.127|0.8351
71143436|NCT01009060|141780918|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.088||||0.4541|TWO_SIDED|90.0|-0.287|0.11|||Mixed Model Repeated Measure|||Week 3||0.110|-0.287|0.4541
71143437|NCT01009060|141780918|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.089||||0.4148|TWO_SIDED|90.0|-0.272|0.093|||Mixed Model Repeated Measure|||Week 4||0.093|-0.272|0.4148
71143438|NCT01009060|141780918|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.086||||0.3887|TWO_SIDED|90.0|-0.082|0.254|||Mixed Model Repeated Measure|||Week 5||0.254|-0.082|0.3887
71143439|NCT01009060|141780918|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.195||||0.2594|TWO_SIDED|90.0|-0.093|0.484|||Mixed Model Repeated Measure|||Week 6||0.484|-0.093|0.2594
71143440|NCT01009060|141780918|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.103||||0.4778|TWO_SIDED|90.0|-0.139|0.344|||Mixed Model Repeated Measure|||Week 7||0.344|-0.139|0.4778
71143441|NCT01009060|141780919|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.737||||0.6947|TWO_SIDED|90.0|-3.884|2.409|||ANCOVA|||||2.409|-3.884|0.6947
71143442|NCT01009060|141780920|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.252||||0.1399|TWO_SIDED|90.0|-0.535|0.03|||Mixed Model Repeated Measure||For Speed of Processing/Simple Reaction Time|||0.030|-0.535|0.1399
71143443|NCT01009060|141780920|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.179||||0.3992|TWO_SIDED|90.0|-0.176|0.534|||Mixed Model Repeated Measure||For Attention/Vigilance|||0.534|-0.176|0.3992
71143444|NCT01009060|141780920|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.391||||0.1547|TWO_SIDED|90.0|-0.063|0.845|||Mixed Model Repeated Measure||For Working Memory|||0.845|-0.063|0.1547
71143445|NCT01009060|141780920|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.279||||0.2531|TWO_SIDED|90.0|-0.127|0.685|||Mixed Model Repeated Measure||For Visual Learning|||0.685|-0.127|0.2531
71143446|NCT01009060|141780920|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.398||||0.2417|TWO_SIDED|90.0|-0.167|0.963|||Mixed Model Repeated Measure||For Verbal Learning|||0.963|-0.167|0.2417
71143447|NCT01009060|141780920|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.177||||0.2069|TWO_SIDED|90.0|-0.055|0.409|||Mixed Model Repeated Measure||For Reasoning/Problem Solving|||0.409|-0.055|0.2069
71143448|NCT01009060|141780920|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.8645|TWO_SIDED|90.0|-0.262|0.322|||Mixed Model Repeated Measure||For Social Cognition|||0.322|-0.262|0.8645
71143449|NCT01009060|141780920|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.069||||0.7873|TWO_SIDED|90.0|-0.364|0.503|||Mixed Model Repeated Measure||For Working Memory (Two-Back Memory)|||0.503|-0.364|0.7873
71143450|NCT01009060|141780921|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.024||||0.0225|TWO_SIDED|90.0|-6.872|-1.175|||ANCOVA||For Speed of Processing|||-1.175|-6.872|0.0225
71143451|NCT01009060|141780921|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.24||||0.3317|TWO_SIDED|95.0|-6.085|1.605|||ANCOVA||For Attention/Vigilance|||1.605|-6.085|0.3317
71143452|NCT01009060|141780921|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.038||||0.3243|TWO_SIDED|90.0|-5.482|1.406|||ANCOVA||For Working Memory|||1.406|-5.482|0.3243
71143453|NCT01009060|141780921|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.746||||0.7497|TWO_SIDED|90.0|-4.667|3.175|||ANCOVA||For Visual Learning|||3.175|-4.667|0.7497
71143454|NCT01009060|141780921|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.112||||0.1585|TWO_SIDED|90.0|-0.537|6.761|||ANCOVA||For Verbal Learning|||6.761|-0.537|0.1585
71143455|NCT01009060|141780921|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.972||||0.6582|TWO_SIDED|90.0|-2.709|4.654|||ANCOVA||For Reasoning and Problem Solving|||4.654|-2.709|0.6582
71143456|NCT01009060|141780921|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.338||||0.9092|TWO_SIDED|90.0|-5.316|4.639|||ANCOVA||For Social Cognition|||4.639|-5.316|0.9092
71143457|NCT01009060|141780922|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.024||||0.4406|TWO_SIDED|90.0|-3.237|1.19|||Mixed Model Repeated Measure|||||1.190|-3.237|0.4406
71143458|NCT01009060|141780923|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.876||||0.5197|TWO_SIDED|90.0|-6.743|2.99|||Mixed Model Repeated Measure|||||2.990|-6.743|0.5197
71143459|NCT01009060|141780924|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.824||||0.4637|TWO_SIDED|90.0|-2.334|5.982|||Mixed Model Repeated Measure|||||5.982|-2.334|0.4637
71143460|NCT00119847|141780936|SUPERIORITY||Mean Difference (Net)|-0.04||||0.34|TWO_SIDED|95.0|-0.12|0.04||p\<0.05 required for statistical significance|t-test, 2 sided|||The planned sample size of 300 subjects was chosen to provide 80% power to detect a clinically relevant difference of 0.1 in the change in α1 from baseline to 1 year between the 2 treatment groups on the basis of data from prior studies that indicated that baseline levels of α1 would be 1.0 with a common SD of 0.2.||0.04|-0.12|0.34
71143461|NCT00119847|141780937|SUPERIORITY||Mean Difference (Net)|3.0||||0.45|TWO_SIDED|95.0|-4.8|10.7||p\<0.01 required for statistical significance|t-test, 2 sided|||||10.7|-4.8|0.45
71143462|NCT00119847|141780938|SUPERIORITY||Mean Difference (Net)|2.2||||0.23|TWO_SIDED|95.0|-1.4|5.9||p\<0.01 required for statistical significance|t-test, 2 sided|||||5.9|-1.4|0.23
71143463|NCT00286442|141780944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||<|0.001|TWO_SIDED|95.0|-0.68|-0.32||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Analysis of covariance (ANCOVA) with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at wk 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=500 participants had 95% power to detect a treatment difference as small as 0.4% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level and \>=80% of participants meeting per protocol criteria.||-0.32|-0.68|<0.001
71143464|NCT00286442|141780944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|||<|0.001|TWO_SIDED|95.0|-0.67|-0.3||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at week 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=500 participants had 95% power to detect a treatment difference as small as 0.4% in the per protocol analysis set assuming SD=0.8%, 2-sided test at 0.05 significance level and \>=80% of participants meeting per protocol criteria.||-0.30|-0.67|<0.001
71143465|NCT00286442|141780945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|||<|0.001|TWO_SIDED|95.0|-0.37|-0.16||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.16|-0.37|<0.001
70868816|NCT00345839|141223668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19||||||No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.190
71143466|NCT00286442|141780945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||<|0.001|TWO_SIDED|95.0|-0.4|-0.19||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.19|-0.40|<0.001
70868817|NCT00345839|141223668|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.72|1.07|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.07|0.72|
70868818|NCT00345839|141223669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.277||||||No adjustments for multiple comparisons were made for this endpoint.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.277
70868819|NCT00345839|141223669|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.8|1.07|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.07|0.80|
71143467|NCT00286442|141780946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|||<|0.001|TWO_SIDED|95.0|-0.52|-0.24||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.24|-0.52|<0.001
71143468|NCT00286442|141780946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|||<|0.001|TWO_SIDED|95.0|-0.52|-0.24||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.24|-0.52|<0.001
71143469|NCT00286442|141780947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||<|0.001|TWO_SIDED|95.0|-0.66|-0.34||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.34|-0.66|<0.001
71143470|NCT00286442|141780947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||<|0.001|TWO_SIDED|95.0|-0.66|-0.34||No multiplicity adjustments|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.34|-0.66|<0.001
71143471|NCT00286442|141780948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|||<|0.001|TWO_SIDED|95.0|-0.7|-0.36||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.36|-0.70|<0.001
71143472|NCT00286442|141780948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|||<|0.001|TWO_SIDED|95.0|-0.69|-0.34||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.34|-0.69|<0.001
71143473|NCT00286442|141780949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|||<|0.001|TWO_SIDED|95.0|-0.69|-0.34||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.34|-0.69|<0.001
71143474|NCT00286442|141780949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|||<|0.001|TWO_SIDED|95.0|-0.69|-0.34||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.34|-0.69|<0.001
71143475|NCT00286442|141780950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||<|0.001|TWO_SIDED|95.0|-20.7|-6.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates. Missing data imputed with LOCF.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the metformin arm.|||-6.8|-20.7|<0.001
71143476|NCT00286442|141780950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.9|||<|0.001|TWO_SIDED|95.0|-18.9|-4.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates. Missing data imputed with LOCF.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the metformin arm.|||-4.9|-18.9|<0.001
71143477|NCT00286442|141780951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.7|||<|0.001|TWO_SIDED|95.0|-23.9|-9.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates. Missing data imputed with LOCF.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.5|-23.9|<0.001
70868820|NCT00345839|141223670|SUPERIORITY_OR_OTHER_LEGACY|||||||0.607||||||No adjustments for multiple comparisons were made for this endpoint.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.607
70868821|NCT00345839|141223670|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.82|1.4|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.40|0.82|
70868822|NCT00345839|141223671|SUPERIORITY_OR_OTHER_LEGACY|||||||0.218||||||No adjustments for multiple comparisons were made for this endpoint.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.218
70868823|NCT00345839|141223671|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.75|1.07|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.07|0.75|
70868824|NCT00345839|141223672|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||No adjustments for multiple comparisons were made for this endpoint.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||<0.001
71143478|NCT00286442|141780951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|||<|0.001|TWO_SIDED|95.0|-24.1|-9.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates. Missing data imputed with LOCF.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.6|-24.1|<0.001
71143479|NCT00286442|141780952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.8|||<|0.001|TWO_SIDED|95.0|-24.6|-11.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-11.0|-24.6|<0.001
71143480|NCT00286442|141780952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.5|||<|0.001|TWO_SIDED|95.0|-24.3|-10.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.6|-24.3|<0.001
71143481|NCT00286442|141780953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.1|||<|0.001|TWO_SIDED|95.0|-28.0|-12.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-12.2|-28.0|<0.001
71143482|NCT00286442|141780953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.6|||<|0.001|TWO_SIDED|95.0|-25.6|-9.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.7|-25.6|<0.001
71143483|NCT00286442|141780954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.2|||<|0.001|TWO_SIDED|95.0|-25.6|-8.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.9|-25.6|<0.001
71143484|NCT00286442|141780954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.0|||<|0.001|TWO_SIDED|95.0|-25.4|-8.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.6|-25.4|<0.001
71143485|NCT00286442|141780955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.1|||<|0.001|TWO_SIDED|95.0|-27.4|-10.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.8|-27.4|<0.001
71143486|NCT00286442|141780955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.7|||<|0.001|TWO_SIDED|95.0|-25.0|-8.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.3|-25.0|<0.001
71143487|NCT00286442|141780956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.1|||<|0.001|TWO_SIDED|95.0|-26.7|-9.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.4|-26.7|<0.001
71143488|NCT00286442|141780956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.5|||<|0.001|TWO_SIDED|95.0|-24.2|-6.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-6.8|-24.2|<0.001
71143489|NCT00286442|141780957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.7|||<|0.001|TWO_SIDED|95.0|-27.3|-10.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.2|-27.3|<0.001
71143490|NCT00286442|141780957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.4|||<|0.001|TWO_SIDED|95.0|-25.9|-8.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.8|-25.9|<0.001
71143491|NCT00286442|141780958|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.372|||<|0.001|TWO_SIDED|95.0|0.213|0.65||no multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.650|0.213|<0.001
70868825|NCT00345839|141223672|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.36|0.54|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||0.54|0.36|
70868826|NCT01960400|141223673|SUPERIORITY_OR_OTHER|||||||0.065||||||"The statistical signifiance level : p\<0.05. After treatment (T1) Pain severity p=0.065~Sub-scale:~* Present pain p=0.046\*~* Average pain p=0.381~* Most intense pain p=0.064~* Least intense pain p=0.142"|ANOVA|To assess the effectiveness of interventions (inter-group differences), a mixed-model ANOVA (time X group interaction) was used.||For the severity of pain, the calculations have revealed that only this pain now had an acceptable statistical power, of 77.1% after treatment (T1).||||0.065
70868827|NCT01960400|141223674|SUPERIORITY_OR_OTHER|||||||0.049||||||interaction group X time|ANOVA|||||||0.049
70868828|NCT01960400|141223675|SUPERIORITY_OR_OTHER|||||||0.035||||||interaction group X time|ANOVA|||||||0.035
70868829|NCT01960400|141223676|SUPERIORITY_OR_OTHER|||||||0.046||||||interaction group X time|ANOVA|||||||0.046
70868830|NCT03298867|141223677|SUPERIORITY||Stratified difference in percentages|73.45|STANDARD_ERROR_OF_MEAN|7.43|<|0.001|TWO_SIDED|95.0|58.89|88.01||Two-sided p-value calculated assuming the test statistic was distributed as a standard normal random variable.|Cochran-Mantel-Haenszel||Stratified difference (teprotumumab - placebo) is a weighted average of the difference within each stratum. Estimates from the 2 strata (tobacco user, tobacco non-user) were combined with Cochran-Mantel-Haenszel (CMH) weights.|||88.01|58.89|<0.001
70868831|NCT03298867|141223678|SUPERIORITY||Stratified difference in percentages|70.82|STANDARD_ERROR_OF_MEAN|7.62|<|0.001|TWO_SIDED|95.0|55.89|85.75||Two-sided p-value calculated assuming the test statistic was distributed as a standard normal random variable.|Cochran-Mantel-Haenszel||Stratified difference (teprotumumab - placebo) is a weighted average of the difference within each stratum. Estimates from the 2 strata (tobacco user, tobacco non-user) were combined with CMH weights.|||85.75|55.89|<0.001
70868832|NCT03298867|141223679|SUPERIORITY||Stratified difference in percentages|36.03|STANDARD_ERROR_OF_MEAN|9.51|<|0.001|TWO_SIDED|95.0|17.39|54.67||Two-sided p-value calculated assuming the test statistic was distributed as a standard normal random variable.|Cochran-Mantel-Haenszel||Stratified difference (teprotumumab - placebo) is a weighted average of the difference within each stratum. Estimates from the 2 strata (tobacco user, tobacco non-user) were combined with CMH weights.|||54.67|17.39|<0.001
70868833|NCT03298867|141223680|SUPERIORITY||LS mean difference|-2.28|STANDARD_ERROR_OF_MEAN|0.244|<|0.001|TWO_SIDED|95.0|-2.77|-1.8||Results obtained from an MMRM with an unstructured covariance matrix including the following terms: Baseline value, tobacco use status, treatment group, visit, visit-by-treatment interaction and visit-by-Baseline-value interaction.|mixed model for repeated measures (MMRM)|||||-1.80|-2.77|<0.001
70868834|NCT03298867|141223681|SUPERIORITY||Stratified difference in percentages|39.29|STANDARD_ERROR_OF_MEAN|12.11||0.001|TWO_SIDED|95.0|15.55|63.02||Two-sided p-value calculated assuming the test statistic was distributed as a standard normal random variable.|Cochran-Mantel-Haenszel||Stratified difference is a weighted average of the difference within each stratum. Estimates from the 2 strata (tobacco user, tobacco non-user) were combined with CMH weights.|||63.02|15.55|0.001
70868835|NCT03298867|141223682|SUPERIORITY||Difference in LS mean|9.36|STANDARD_ERROR_OF_MEAN|2.651|<|0.001|TWO_SIDED|95.0|4.08|14.64||Results obtained from an MMRM with an unstructured covariance matrix including the following terms: Baseline value, tobacco use status, treatment group, visit, visit-by-treatment interaction and visit-by-Baseline-value interaction.|mixed model for repeated measures (MMRM)|||||14.64|4.08|<0.001
70868836|NCT00743483|141223683|SUPERIORITY_OR_OTHER|||||||0.2179|TWO_SIDED||||||t-test, 2 sided|||||||0.2179
70868837|NCT01466153|141223684|SUPERIORITY_OR_OTHER|||||||0.4475|||||||Cochran-Mantel-Haenszel|||||||0.4475
70868838|NCT01466153|141223688|SUPERIORITY_OR_OTHER|||||||0.3206|||||||Cochran-Mantel-Haenszel|||||||0.3206
70868839|NCT01466153|141223689|SUPERIORITY_OR_OTHER|||||||0.313|||||||Cochran-Mantel-Haenszel|||||||0.3130
70868840|NCT01466153|141223691|SUPERIORITY_OR_OTHER|||||||0.9527|||||||Log Rank|||||||0.9527
70868841|NCT05263895|141223706|OTHER||Ratio of Adjusted Geometric means|90.54|||||TWO_SIDED|90.0|79.85|102.65||||||Test: Nirmatrelvir (slower dissolution tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||102.65|79.85|
70868842|NCT05263895|141223706|OTHER||Ratio of Adjusted Geometric Means|102.78|||||TWO_SIDED|90.0|90.65|116.53||||||Test: Nirmatrelvir (large particle size tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||116.53|90.65|
70868843|NCT05263895|141223706|OTHER||Ratio of Adjusted Geometric Means|138.15|||||TWO_SIDED|90.0|118.03|161.69||||||Test: Nirmatrelvir (SDD suspension)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||161.69|118.03|
70868844|NCT05263895|141223706|OTHER||Ratio of Adjusted Geometric Means|30.8|||||TWO_SIDED|90.0|25.7|35.2||||||Test: Nirmatrelvir (SDD suspension) 300 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||35.20|25.70|
70868845|NCT05263895|141223707|OTHER||Ratio of Adjusted Geometric Means|91.26|||||TWO_SIDED|90.0|80.46|103.51||||||Test: Nirmatrelvir (slower dissolution tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||103.51|80.46|
70868846|NCT05263895|141223707|OTHER||Ratio of Adjusted Geometric Means|102.49|||||TWO_SIDED|90.0|90.36|116.26||||||Test: Nirmatrelvir (large particle size tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||116.26|90.36|
70868847|NCT05263895|141223707|OTHER||Ratio of Adjusted Geometric Means|136.99|||||TWO_SIDED|90.0|117.09|160.27||||||Test: Nirmatrelvir (SDD suspension)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||160.27|117.09|
70868848|NCT05263895|141223707|OTHER||Ratio of Adjusted Geometric Means|29.77|||||TWO_SIDED|90.0|25.45|34.83||||||Test: Nirmatrelvir (SDD suspension) 300 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||34.83|25.45|
70868849|NCT05263895|141223708|OTHER||Ratio of Adjusted Geometric Means|94.28|||||TWO_SIDED|90.0|80.77|110.05||||||Test: Nirmatrelvir (slower dissolution tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||110.05|80.77|
70868850|NCT05263895|141223708|OTHER||Ratio of Adjusted Geometric Means|108.6|||||TWO_SIDED|90.0|93.04|126.76||||||Test: Nirmatrelvir (large particle size tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||126.76|93.04|
70868851|NCT05263895|141223708|OTHER||Ratio of Adjusted Geometric Means|264.12|||||TWO_SIDED|90.0|232.32|300.27||||||Test: Nirmatrelvir (SDD suspension)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||300.27|232.32|
70868852|NCT05263895|141223708|OTHER||Ratio of Adjusted Geometric Means|145.53|||||TWO_SIDED|90.0|128.01|165.45||||||Test: Nirmatrelvir (SDD suspension) 300 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||165.45|128.01|
70868853|NCT03281577|141223723|SUPERIORITY||Least Squares Mean Differences|-25.81||||0.0012|TWO_SIDED|95.0|-41.757|-9.858||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% confidence interval (CI) are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as covariate.|||-9.858|-41.757|0.0012
70868854|NCT03281577|141223723|SUPERIORITY||Least Squares Mean Differences|-27.52||||0.0018|TWO_SIDED|95.0|-45.224|-9.813||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||-9.813|-45.224|0.0018
70868855|NCT03281577|141223723|SUPERIORITY||Least Squares Mean Differences|-41.76|||<|0.0001|TWO_SIDED|95.0|-59.616|-23.902||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||-23.902|-59.616|<.0001
70951644|NCT00874731|141404131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.49|||||TWO_SIDED|95.0|-0.79|5.78|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|5.78|-0.79|
70868856|NCT03281577|141223724|SUPERIORITY||Least Squares Mean Differences|0.72||||0.259|TWO_SIDED|95.0|-0.364|1.795||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 4 Hours, Day 2||1.795|-0.364|0.2590
71143492|NCT00286442|141780958|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.405||||0.002|TWO_SIDED|95.0|0.231|0.708||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.708|0.231|0.002
71143493|NCT00286442|141780959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.302||||0.002|TWO_SIDED|95.0|0.143|0.635||no multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.635|0.143|0.002
71143494|NCT00286442|141780959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.236|||<|0.001|TWO_SIDED|95.0|0.109|0.51|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.510|0.109|<0.001
71143495|NCT00286442|141780960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.634|TWO_SIDED|95.0|-7.4|4.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.5|-7.4|0.634
71143496|NCT00286442|141780960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5||||0.136|TWO_SIDED|95.0|-10.5|1.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.4|-10.5|0.136
71143497|NCT00286442|141780961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.274|TWO_SIDED|95.0|-6.9|2.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.0|-6.9|0.274
71143498|NCT00286442|141780961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6||||0.046|TWO_SIDED|95.0|-9.1|-0.1||No multiplicity adjustments.|ANCOVA||Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.1|-9.1|0.046
71143499|NCT00286442|141780962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.655|TWO_SIDED|95.0|-7.4|4.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.6|-7.4|0.655
71143500|NCT00286442|141780962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.645|TWO_SIDED|95.0|-7.4|4.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.6|-7.4|0.645
71143501|NCT00286442|141780963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.748|TWO_SIDED|95.0|-6.3|4.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.6|-6.3|0.748
71143502|NCT00286442|141780963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.432|TWO_SIDED|95.0|-7.7|3.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.3|-7.7|0.432
71143503|NCT00286442|141780964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.427|TWO_SIDED|95.0|-7.8|3.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.3|-7.8|0.427
71143504|NCT00286442|141780964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.746|TWO_SIDED|95.0|-4.6|6.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.5|-4.6|0.746
71143505|NCT00286442|141780965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.727|TWO_SIDED|95.0|-5.0|7.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.2|-5.0|0.727
71143506|NCT00286442|141780965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.601||||1.6|TWO_SIDED|95.0|-4.5|7.8||No multiplicity adjustments|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.8|-4.5|1.6
71143507|NCT00286442|141780966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.19||||0.066|TWO_SIDED|95.0|-0.15|4.52||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.52|-0.15|0.066
71143508|NCT00286442|141780966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.18|TWO_SIDED|95.0|-0.74|3.93||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.93|-0.74|0.180
71143509|NCT00286442|141780967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.944|TWO_SIDED|95.0|-5.02|4.68||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.68|-5.02|0.944
71143510|NCT00286442|141780967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.316|TWO_SIDED|95.0|-7.4|2.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.40|-7.40|0.316
71143511|NCT00286442|141780968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.901|TWO_SIDED|95.0|-5.42|4.77||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.77|-5.42|0.901
71143512|NCT00286442|141780968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.45||||0.578|TWO_SIDED|95.0|-6.59|3.68||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.68|-6.59|0.578
71143513|NCT00286442|141780969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.708|TWO_SIDED|95.0|-2.67|3.93||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.93|-2.67|0.708
71143514|NCT00286442|141780969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.601|TWO_SIDED|95.0|-2.44|4.21||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.21|-2.44|0.601
71143515|NCT00286442|141780970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12||||0.398|TWO_SIDED|95.0|-1.48|3.72||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.72|-1.48|0.398
71143516|NCT00286442|141780970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07||||0.425|TWO_SIDED|95.0|-1.56|3.69||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.69|-1.56|0.425
71143517|NCT00286442|141780971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.87||||0.018|TWO_SIDED|95.0|0.5|5.23||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.23|0.50|0.018
71143518|NCT00286442|141780971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22||||0.067|TWO_SIDED|95.0|-0.15|4.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.60|-0.15|0.067
71143519|NCT00286442|141780972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.036||||0.011|TWO_SIDED|95.0|-0.064|-0.009||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.009|-0.064|0.011
71143520|NCT00286442|141780972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.047|||<|0.001|TWO_SIDED|95.0|-0.075|-0.019||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.019|-0.075|<0.001
70951645|NCT00874731|141404132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.48|||||TWO_SIDED|95.0|-0.8|5.76|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|5.76|-0.80|
70951646|NCT00874731|141404133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.89|||||TWO_SIDED|95.0|0.6|7.17|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|7.17|0.60|
71143521|NCT00286442|141780973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|||<|0.001|TWO_SIDED|95.0|-0.07|-0.021||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.021|-0.070|<0.001
71143522|NCT00286442|141780973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.037||||0.004|TWO_SIDED|95.0|-0.062|-0.012||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.012|-0.062|0.004
71143523|NCT00286442|141780974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039||||0.007|TWO_SIDED|95.0|-0.068|-0.011||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm|||-0.011|-0.068|0.007
71143524|NCT00286442|141780974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.037||||0.011|TWO_SIDED|95.0|-0.066|-0.008||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm|||-0.008|-0.066|0.011
70868857|NCT03281577|141223724|SUPERIORITY||Least Squares Mean Differences|1.27||||0.028|TWO_SIDED|95.0|0.119|2.418||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 4 Hours, Day 2||2.418|0.119|0.0280
70868858|NCT03281577|141223724|SUPERIORITY||Least Squares Mean Differences|0.45||||0.6882|TWO_SIDED|95.0|-0.757|1.66||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 4 Hours, Day 2||1.660|-0.757|0.6882
70868859|NCT03281577|141223724|SUPERIORITY||Least Squares Mean Differences|1.87||||0.0062|TWO_SIDED|95.0|0.493|3.25||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 24 Hours, Day 2||3.250|0.493|0.0062
70868860|NCT03281577|141223724|SUPERIORITY||Least Squares Mean Differences|1.19||||0.149|TWO_SIDED|95.0|-0.327|2.717||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 24 Hours, Day 2||2.717|-0.327|0.1490
70868861|NCT03281577|141223724|SUPERIORITY||Least Squares Mean Differences|0.63||||0.6285|TWO_SIDED|95.0|-0.931|2.2||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 24 Hours, Day 2||2.200|-0.931|0.6285
70868862|NCT03281577|141223724|SUPERIORITY||Least Squares Mean Differences|1.29||||0.0358|TWO_SIDED|95.0|0.073|2.501||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 48 Hours, Day 2||2.501|0.073|0.0358
70868863|NCT03281577|141223724|SUPERIORITY||Least Squares Mean Differences|1.33||||0.043|TWO_SIDED|95.0|0.035|2.621||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 48 Hours, Day 2||2.621|0.035|0.0430
71143525|NCT00286442|141780975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.052|||<|0.001|TWO_SIDED|95.0|-0.08|-0.024||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.024|-0.080|<0.001
70868864|NCT03281577|141223724|SUPERIORITY||Least Squares Mean Differences|0.25||||0.9419|TWO_SIDED|95.0|-1.107|1.611||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 48 Hours, Day 2||1.611|-1.107|0.9419
70868865|NCT03281577|141223725|SUPERIORITY||Least Squares Mean Differences|33.12||||0.0436|TWO_SIDED|95.0|0.799|65.439||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||65.439|0.799|0.0436
70868866|NCT03281577|141223725|SUPERIORITY||Least Squares Mean Differences|57.98||||0.0007|TWO_SIDED|95.0|23.555|92.396||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||92.396|23.555|0.0007
71143526|NCT00286442|141780975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044||||0.003|TWO_SIDED|95.0|-0.072|-0.015||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.015|-0.072|0.003
71143527|NCT00286442|141780976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.046||||0.078|TWO_SIDED|95.0|-0.097|0.005||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.005|-0.097|0.078
71143528|NCT00286442|141780976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005||||0.86|TWO_SIDED|95.0|-0.056|0.047||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.047|-0.056|0.860
70868867|NCT03281577|141223725|SUPERIORITY||Least Squares Mean Differences|44.44||||0.0134|TWO_SIDED|95.0|8.249|80.629||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||80.629|8.249|0.0134
70868868|NCT03281577|141223726|SUPERIORITY||Least Squares Mean Differences|-10.27||||0.0789|TWO_SIDED|95.0|-21.507|0.96||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||0.960|-21.507|0.0789
70868869|NCT03281577|141223726|SUPERIORITY||Least Squares Mean Differences|-13.28||||0.027|TWO_SIDED|95.0|-25.242|-1.314||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||-1.314|-25.242|0.0270
71143529|NCT00286442|141780977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.053||||0.048|TWO_SIDED|95.0|-0.106|-0.001||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.001|-0.106|0.048
71143530|NCT00286442|141780977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004||||0.889|TWO_SIDED|95.0|-0.057|0.05||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.050|-0.057|0.889
71143531|NCT00286442|141780978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.336||||0.031|TWO_SIDED|95.0|0.03|0.642||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.642|0.030|0.031
71143532|NCT00286442|141780978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.304||||0.051|TWO_SIDED|95.0|-0.002|0.611||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.611|-0.002|0.051
71143533|NCT00286442|141780979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088||||0.563|TWO_SIDED|95.0|-0.209|0.384||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.384|-0.209|0.563
71143534|NCT00286442|141780979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111||||0.467|TWO_SIDED|95.0|-0.188|0.41||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.410|-0.188|0.467
71143535|NCT00286442|141780980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.187||||0.243|TWO_SIDED|95.0|-0.127|0.501||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.501|-0.127|0.243
71143536|NCT00286442|141780980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.279||||0.083|TWO_SIDED|95.0|-0.037|0.595||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.595|-0.037|0.083
71143537|NCT00286442|141780981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155||||0.321|TWO_SIDED|95.0|-0.152|0.463||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.463|-0.152|0.321
71143538|NCT00286442|141780981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.268||||0.089|TWO_SIDED|95.0|-0.041|0.577||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.577|-0.041|0.089
71143539|NCT00286442|141780982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144||||0.305|TWO_SIDED|95.0|-0.132|0.42||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.420|-0.132|0.305
70868870|NCT03281577|141223726|SUPERIORITY||Least Squares Mean Differences|-11.63||||0.075|TWO_SIDED|95.0|-24.206|0.952||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||0.952|-24.206|0.0750
71143540|NCT00286442|141780982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.191||||0.177|TWO_SIDED|95.0|-0.086|0.468||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.468|-0.086|0.177
70872250|NCT03782792|141229718|OTHER||Risk Difference (RD)|0.487||||0.0004|TWO_SIDED|95.0|0.215|0.672||One-sided P Value.|Suissa-Shuster Z-pooled test||Risk difference=Response rate of spesolimab - response rate of placebo.|The Suissa-Shuster Z-pooled test was implemented to test the treatment effect on the primary endpoint on the RS (estimand EN) at a 1-sided, alpha level of 0.025. Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.672|0.215|0.0004
70951647|NCT00874731|141404134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-4.85|1.86|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|1.86|-4.85|
70951648|NCT00186017|141404135|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||.08
70951649|NCT00186017|141404136|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Wilcoxon (Mann-Whitney)|||||||>.1
70951650|NCT00186017|141404137|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Wilcoxon (Mann-Whitney)|||||||>.1
71143541|NCT00286442|141780983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.394||||0.007|TWO_SIDED|95.0|0.107|0.68||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.680|0.107|0.007
71143542|NCT00286442|141780983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.263||||0.074|TWO_SIDED|95.0|-0.025|0.55||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.550|-0.025|0.074
71143543|NCT00286442|141780984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.15|||<|0.001|TWO_SIDED|95.0|2.117|17.864||no multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||17.864|2.117|<0.001
71143544|NCT00286442|141780984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.322||||0.002|TWO_SIDED|95.0|1.82|15.564||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||15.564|1.820|0.002
71143545|NCT00286442|141780985|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.092|||<|0.001|TWO_SIDED|95.0|3.271|11.345||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||11.345|3.271|<0.001
71143546|NCT00286442|141780985|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.451|||<|0.001|TWO_SIDED|95.0|2.388|8.296||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||8.296|2.388|<0.001
71143547|NCT00286442|141780986|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.238|||<|0.001|TWO_SIDED|95.0|2.327|7.717||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||7.717|2.327|<0.001
71143548|NCT00286442|141780986|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.293|||<|0.001|TWO_SIDED|95.0|1.814|5.979|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||5.979|1.814|<0.001
71143549|NCT00286442|141780987|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.103|||<|0.001|TWO_SIDED|95.0|2.428|6.934||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||6.934|2.428|<0.001
71143550|NCT00286442|141780987|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.314|||<|0.001|TWO_SIDED|95.0|2.545|7.312||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||7.312|2.545|<0.001
70951651|NCT03004404|141404277|OTHER||Slope|0.748|STANDARD_ERROR_OF_MEAN|0.0743|||TWO_SIDED|95.0|0.5959|0.9001|||||Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|In the SRD part of the trial, dose proportionality for AUC0-inf was assessed in the 25 mg to 400 mg dose groups (BI 730357 tablets administered under fasted conditions) using a power model (regression model applied to log-transformed data).||0.9001|0.5959|
71143551|NCT00286442|141780988|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.601|||<|0.001|TWO_SIDED|95.0|2.554|12.282||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||12.282|2.554|<0.001
71143552|NCT00286442|141780988|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.793|||<|0.001|TWO_SIDED|95.0|2.645|12.684||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||12.684|2.645|<0.001
71143553|NCT00286442|141780989|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.449||||0.085|TWO_SIDED|95.0|0.883|6.797||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||6.797|0.883|0.085
70951652|NCT03004404|141404277|OTHER||Ratio T/R|118.71|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|90.0|94.57|149.03|||||Standard error of the mean is the geometric standard error of the mean. The geometric mean ratio was calculated as: tablet 400mg fed1 (T)/400mg fed2(R), T/R.|Relative bioavailability of AUC0-inf for the SRD part was performed to test the effect of food intake on the PK of 400 mg BI 730357 tablets. The intra-individual comparison of fed conditions was done using an Analysis of Variance (ANOVA) model on the logarithmic scale.||149.03|94.57|
70951653|NCT03004404|141404277|OTHER||Geometric mean ratio T1/R (%)|124.79|STANDARD_ERROR_OF_MEAN|1.036|||TWO_SIDED|90.0|116.858|133.255|||||Standard error of the mean is actually geometric standard error of the mean. The geometric mean ratio was calculated as: oral solution in fasted state (test treatment T1)/tablet in fasted state (reference treatment R), T1/R.|Estimation of relative bioavailability of AUC0-inf was based on ANOVA model on the logarithmic scale, included effects: 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random|Relative bioavailability of BI 730357 for Oral solution (PfOS) fasted (T1) vs. tablet fasted (R) was assessed by the point estimators (geometric means) of the intra-subject ratio of Auc0-inf and their two-sided 90% confidence intervals . No hypothesis was tested.|133.255|116.858|
70951654|NCT03004404|141404277|OTHER||Geometric mean ratio T2/R (%)|125.17|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|90.0|112.89|138.8|||||Standard error of the mean is actually geometric standard error of the mean. The geometric mean ratio was calculated as: tablet in fed state (test treatment T2)/tablet in fasted state (reference treatment R), T2/R.|Estimation of relative bioavailability of AUC0-inf was based on ANOVA model on the logarithmic scale, included effects: 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random|Relative bioavailability of BI 730357 for tablet fed (T2) vs. tablet fasted (R) was assessed by the point estimators (geometric means) of the intra-subject ratio of AUC0-inf and their two-sided 90% confidence intervals . No hypothesis was tested.|138.80|112.89|
70951655|NCT03004404|141404278|OTHER||Slope|0.7065|STANDARD_ERROR_OF_MEAN|0.0587|||TWO_SIDED|95.0|0.5863|0.8267|||||Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1|In the SRD part of the trial, dose proportionality for Cmax was assessed in the 25 mg to 400 mg dose groups (BI 730357 tablets administered under fasted conditions) using a power model (regression model applied to log-transformed data).||0.8267|0.5863|
70951656|NCT03004404|141404278|OTHER||Ratio T/R|151.22|STANDARD_ERROR_OF_MEAN|1.107|||TWO_SIDED|90.0|122.781|186.248|||||Standard error of the mean is the geometric standard error of the mean. The geometric mean ratio was calculated as: tablet 400mg fed1 (T)/400mg fed2(R), T/R.|Relative bioavailability of the Cmax for the SRD part was performed to test the effect of food intake on the PK of 400 mg BI 730357 tablets. The intra-individual comparison of fed conditions was done using an ANOVA model on the logarithmic scale.||186.248|122.781|
70951657|NCT03004404|141404278|OTHER||Geometric mean ratio T1/R (%)|293.21|STANDARD_ERROR_OF_MEAN|1.069|||TWO_SIDED|90.0|259.044|331.891|||||Standard error of the mean is the geometric standard error of the mean. The geometric mean ratio was calculated as: oral solution in fasted state (test treatment T1)/tablet in fasted state (reference treatment R), T1/R.|Estimation of relative bioavailability of Cmax based on ANOVA model on the logarithmic scale, included effects: 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random|Relative bioavailability of BI 730357 for Oral solution (PfOS) fasted (T1) vs. tablet fasted (R) was assessed by the point estimators (geometric means) of the intra-subject ratio of Cmax and their two-sided 90% confidence intervals . No hypothesis was tested.|331.891|259.044|
70951658|NCT03004404|141404278|OTHER||Geometric mean ratio T2/R (%)|180.53|STANDARD_ERROR_OF_MEAN|1.059|||TWO_SIDED|90.0|162.369|200.732|||||Standard error of the mean is the geometric standard error of the mean. The geometric mean ratio was calculated as: tablet in fed state (test treatment T2)/tablet in fasted state (reference treatment R), T2/R.|Estimation of relative bioavailability of Cmax was based on ANOVA model on the logarithmic scale, included effects: 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random|Relative bioavailability of BI 730357 for tablet fasted (T2) vs. tablet fasted (R) was assessed by the point estimators (geometric means) of the intra-subject ratio of Cmax and their two-sided 90% confidence intervals . No hypothesis was tested.|200.732|162.369|
70951659|NCT01937975|141404279|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.97|||||TWO_SIDED|90.0|0.87|1.09|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.09|0.87|
70951660|NCT01937975|141404279|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.85|||||TWO_SIDED|90.0|0.58|1.25|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.25|0.58|
70951661|NCT01937975|141404279|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.83|||||TWO_SIDED|90.0|0.56|1.22|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.22|0.56|
70951662|NCT01937975|141404279|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.65|||||TWO_SIDED|90.0|1.09|2.49|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||2.49|1.09|
70951663|NCT01937975|141404280|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.98|||||TWO_SIDED|90.0|0.81|1.19|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.19|0.81|
70951664|NCT01937975|141404280|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.79|||||TWO_SIDED|90.0|0.54|1.16|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.16|0.54|
70951665|NCT01937975|141404280|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.78|||||TWO_SIDED|90.0|0.53|1.14|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.14|0.53|
70951666|NCT01937975|141404280|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.6|||||TWO_SIDED|90.0|1.06|2.42|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||2.42|1.06|
71143554|NCT00286442|141780989|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.958||||0.034|TWO_SIDED|95.0|1.087|8.046||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||8.046|1.087|0.034
71143555|NCT00286442|141780990|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.404||||0.639|TWO_SIDED|95.0|0.34|5.803||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||5.803|0.340|0.639
71143556|NCT00286442|141780990|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.959||||0.956|TWO_SIDED|95.0|0.218|4.223||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||4.223|0.218|0.956
70951667|NCT01937975|141404281|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.96|||||TWO_SIDED|90.0|0.75|1.22|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.22|0.75|
70951668|NCT01937975|141404281|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.92|||||TWO_SIDED|90.0|0.57|1.48|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.48|0.57|
71143557|NCT00286442|141780991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.439|TWO_SIDED|95.0|-0.63|0.27||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.27|-0.63|0.439
71143558|NCT00286442|141780991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.075|TWO_SIDED|95.0|-0.86|0.04||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.04|-0.86|0.075
71143559|NCT00286442|141780992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.305|TWO_SIDED|95.0|-0.26|0.83||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.83|-0.26|0.305
70872251|NCT03782792|141229719|OTHER||Risk Difference (RD)|0.317||||0.0118|TWO_SIDED|95.0|0.022|0.527||One-sided P Value.|Suissa-Shuster Z-pooled test||Risk difference=Response rate of spesolimab - response rate of placebo.|The Suissa-Shuster Z-pooled test was implemented to test the treatment effect on the RS (estimand EN) at a 1-sided, alpha level of 0.025. Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.527|0.022|0.0118
70872252|NCT03782792|141229720|OTHER||Risk Difference (RD)|0.346||||0.0081|TWO_SIDED|95.0|0.058|0.554||One-sided P Value.|Suissa-Shuster Z-pooled test||Risk difference=Response rate of spesolimab - response rate of placebo.|The Suissa-Shuster Z-pooled test was implemented to test the treatment effect on the RS (estimand EN) at a 1-sided, alpha level of 0.025. Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.554|0.058|0.0081
70951669|NCT01937975|141404281|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.88|||||TWO_SIDED|90.0|0.54|1.42|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.42|0.54|
70951670|NCT01937975|141404281|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.66|||||TWO_SIDED|90.0|0.99|2.77|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||2.77|0.99|
70951671|NCT01937975|141404284|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|0.92|1.15|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.15|0.92|
70951672|NCT01937975|141404284|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.18|||||TWO_SIDED|90.0|0.8|1.73|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.73|0.80|
71143560|NCT00286442|141780992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.788|TWO_SIDED|95.0|-0.63|0.47||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.47|-0.63|0.788
70951673|NCT01937975|141404284|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.21|||||TWO_SIDED|90.0|0.82|1.78|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.78|0.82|
70951674|NCT01937975|141404284|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.61|||||TWO_SIDED|90.0|0.4|0.92|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||0.92|0.40|
70951675|NCT01937975|141404285|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.63|1.42|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|||1.42|0.63|
70951676|NCT01937975|141404285|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.61|||||TWO_SIDED|90.0|0.39|0.94|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|||0.94|0.39|
71143561|NCT00286442|141780993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.93|TWO_SIDED|95.0|-0.58|0.63||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.63|-0.58|0.930
71143562|NCT00286442|141780993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.559|TWO_SIDED|95.0|-0.79|0.43||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.43|-0.79|0.559
71143563|NCT00286442|141780994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.996|TWO_SIDED|95.0|-0.66|0.66||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.66|-0.66|0.996
71143564|NCT00286442|141780994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.407|TWO_SIDED|95.0|-0.94|0.38||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.38|-0.94|0.407
71143565|NCT02542865|141781041|SUPERIORITY||Mean Difference (Net)|-6.0|STANDARD_ERROR_OF_MEAN|1.56||0.0628|TWO_SIDED|95.0|-12.7|0.8|||ANCOVA|Analysis of variance(ANCOVA):cluster/school=random effect,product group and gender=fixed effects,baseline Individual Dietary Diversity Score=covariate|Difference is difference in back-transformed adjusted means for Test Group (fortified malt based food plus dietary counselling) minus Control Group (dietary counselling only).|||0.8|-12.7|0.0628
71143566|NCT02542865|141781041|SUPERIORITY||Mean Difference (Net)|-4.9||||0.039|||||||ANCOVA|ANCOVA:cluster/school=random effect,product group and gender=fixed effects,baseline Individual Dietary Diversity Score=covariate|Difference is difference in back-transformed adjusted means for Test Group minus Control Group. The corresponding CI is not presented as there is no direct back-transformation.|Since the distribution of the data was found to be more skewed with more zero counts than was anticipated at the time the trial was designed, an additional analysis of log (+1)-transformed data was performed.||||0.0390
71143567|NCT04571944|141781074|SUPERIORITY||Difference in % vs Placebo|-8.7||||0.129|TWO_SIDED|95.0|-20.1|2.6|||Miettinen and Nurminen method|Analysis was stratified by hospitalization reason (acute disease, elective surgery) and age category (\<75 years, ≥75 years).||||2.6|-20.1|0.129
70951677|NCT01937975|141404286|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.14|||||TWO_SIDED|90.0|1.08|1.21|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.21|1.08|
70951678|NCT01937975|141404286|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.86|||||TWO_SIDED|90.0|0.65|1.14|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.14|0.65|
70951679|NCT01937975|141404286|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.75|1.3|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.30|0.75|
70951680|NCT01937975|141404286|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.86|||||TWO_SIDED|90.0|1.38|2.51|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||2.51|1.38|
70951681|NCT01937975|141404287|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.24|||||TWO_SIDED|90.0|1.17|1.32|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.32|1.17|
71143568|NCT04571944|141781075|OTHER||Difference in % vs. Placebo|0.8|||||TWO_SIDED|95.0|-9.3|11.0||||||||11.0|-9.3|
71143569|NCT04571944|141781076|OTHER||Difference in % vs. Placebo|0.0|||||TWO_SIDED|95.0|-5.1|5.2||||||||5.2|-5.1|
71143570|NCT04571944|141781077|SUPERIORITY||Difference vs. Placebo|-0.5||||0.485|TWO_SIDED|95.0|-2.0|1.0||Based on aligned rank test.|Hodges-Lehmann method|||||1.0|-2.0|0.485
71143571|NCT04571944|141781078|SUPERIORITY||Difference in % vs. Placebo|-8.6||||0.136|TWO_SIDED|95.0|-20.2|2.8|||Miettinen and Nurminen method|Analysis was stratified by hospitalization reason (acute disease, elective surgery) and age category (\<75 years, ≥75 years).||||2.8|-20.2|0.136
70951682|NCT01937975|141404287|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.77|||||TWO_SIDED|90.0|0.56|1.06|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.06|0.56|
70872253|NCT03782792|141229721|OTHER|||||||0.0012||||||One-sided P Value.|Wilcoxon (Mann-Whitney)|||The effect of spesolimab was evaluated by a Wilcoxon rank test using the RS. Any assessments after death, the use of escape medication (before or after Day 8), open label spesolimab on Day 8, or rescue medication with spesolimab after Day 8 were assigned worst ranks for the testing. Missing data at Week 4 were imputed and handled via assessment of ranks.|The difference between treatments, based on the RS, using a modified Hodges-Lehmann (HL) estimate of the median difference and 95% Confidence Intervals could not be calculated due to lack of valid data.|||0.0012
70951683|NCT01937975|141404287|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.95|||||TWO_SIDED|90.0|0.69|1.32|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.32|0.69|
70951684|NCT01937975|141404287|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|2.07|||||TWO_SIDED|90.0|1.46|2.93|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||2.93|1.46|
70951685|NCT01937975|141404288|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.12|||||TWO_SIDED|90.0|1.0|1.26|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.26|1.00|
70951686|NCT01937975|141404288|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.84|||||TWO_SIDED|90.0|0.62|1.13|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.13|0.62|
70868871|NCT01663532|141223752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9||||0.0005|TWO_SIDED|95.0|-6.1|-1.7||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 1.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.||-1.7|-6.1|0.0005
70951687|NCT01937975|141404288|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.7|1.27|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.27|0.70|
70951688|NCT01937975|141404288|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.66|||||TWO_SIDED|90.0|1.21|2.28|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||2.28|1.21|
70951689|NCT01937975|141404291|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.88|||||TWO_SIDED|90.0|0.83|0.92|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||0.92|0.83|
70951690|NCT01937975|141404291|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.16|||||TWO_SIDED|90.0|0.88|1.53|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.53|0.88|
70951691|NCT01937975|141404291|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.01|||||TWO_SIDED|90.0|0.77|1.34|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.34|0.77|
70951692|NCT01937975|141404291|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.54|||||TWO_SIDED|90.0|0.4|0.72|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||0.72|0.40|
70951693|NCT01937975|141404292|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.95|||||TWO_SIDED|90.0|0.7|1.3|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|||1.30|0.70|
70868872|NCT01663532|141223752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.0|||<|0.0001|TWO_SIDED|95.0|-10.0|-4.0||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 2.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.||-4.0|-10.0|<.0001
70868873|NCT01663532|141223752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2|||<|0.0001|TWO_SIDED|95.0|-12.8|-5.6||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at week 4.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.||-5.6|-12.8|<.0001
70868874|NCT01663532|141223752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.1|||<|0.0001|TWO_SIDED|95.0|-15.0|-7.3||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 6.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.||-7.3|-15.0|<.0001
70868875|NCT01663532|141223752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.0|||<|0.0001|TWO_SIDED|95.0|-18.4|-9.6||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 8.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.||-9.6|-18.4|<.0001
70868876|NCT01663532|141223752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.1|||<|0.0001|TWO_SIDED|95.0|-19.4|-10.8||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 10.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.||-10.8|-19.4|<.0001
70868877|NCT01663532|141223753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.0001|TWO_SIDED|95.0|-0.4|-0.1||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 1.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.1|-0.4|0.0001
70868878|NCT01663532|141223753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.2||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 2.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.2|-0.6|<.0001
70868879|NCT01663532|141223753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.4||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 4.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.4|-0.7|<.0001
70951694|NCT01937975|141404292|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.63|||||TWO_SIDED|90.0|0.45|0.89|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|||0.89|0.45|
70951695|NCT01266161|141404299|SUPERIORITY||Mean Difference (Final Values)|23.76|||<|0.001|TWO_SIDED|95.0|16.45|31.07||p-Value from analysis of variance (ANOVA) model, with treatment, baseline PSR, gender terms. To protect type I error at 5% significance, 2 primary parameters tested sequentially: SPRID 8-12 not declared significant unless SPRID 0-12 was significant.|ANOVA|||||31.07|16.45|<0.001
71143572|NCT04913610|141781082|OTHER||||||=|0.036|||||||Mann-Whitney U test|The p-value is for the pairwise comparison of Arm A to Arm E using the Mann-Whitney U test for the percentage per participant.||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.036
70951696|NCT01266161|141404300|SUPERIORITY||Mean Difference (Final Values)|8.42|||<|0.001|TWO_SIDED|95.0|4.13|12.71||p-Value from ANOVA model, with treatment, baseline PSR, and gender terms. To protect type I error at 5% significance, 2 primary parameters tested sequentially: SPRID 8-12 not declared significant unless SPRID 0-12 was significant.|ANOVA|||||12.71|4.13|<0.001
70951697|NCT01266161|141404301|SUPERIORITY||Least-squares means|8.95|||<|0.001|TWO_SIDED|95.0|5.94|11.95||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 0-12.||11.95|5.94|<0.001
70951698|NCT01266161|141404301|SUPERIORITY||Least-squares means|3.15|||<|0.001|TWO_SIDED|95.0|1.45|4.85||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 8-12.||4.85|1.45|<0.001
70951699|NCT01266161|141404301|SUPERIORITY||Least-squares means|6.56|||<|0.001|TWO_SIDED|95.0|2.84|10.27||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 12-24.||10.27|2.84|<0.001
71143573|NCT04913610|141781082|OTHER||||||=|0.53||||||The p-value is for the pairwise comparison of Arm B to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.530
71143574|NCT04913610|141781082|OTHER||||||=|0.852||||||The p-value is for the pairwise comparison of Arm C to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.852
71143575|NCT04913610|141781082|OTHER||||||=|0.366||||||The p-value is for the pairwise comparison of Arm D to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.366
71143576|NCT04913610|141781083|OTHER||||||=|0.869||||||The p-value is for the pairwise comparison of Arm A to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.869
71143577|NCT04913610|141781083|OTHER||||||=|0.973||||||The p-value is for the pairwise comparison of Arm B to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.973
71143578|NCT04913610|141781083|OTHER||||||=|0.744||||||The p-value is for the pairwise comparison of Arm C to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.744
71143579|NCT04913610|141781083|OTHER||||||=|0.794||||||The p-value is for the pairwise comparison of Arm D to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.794
71143580|NCT04913610|141781084|OTHER||||||=|0.559||||||The p-value is for the pairwise comparison of Arm A to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.559
71143581|NCT04913610|141781084|OTHER||||||=|0.786||||||The p-value is for the pairwise comparison of Arm B to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.786
71143582|NCT04913610|141781084|OTHER||||||=|0.423||||||The p-value is for the pairwise comparison of Arm C to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.423
70868880|NCT01663532|141223753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 6.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.5|-0.9|<.0001
70951700|NCT01266161|141404301|SUPERIORITY||Least-squares means|2.02||||0.091|TWO_SIDED|95.0|-0.33|4.37||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 20-24.||4.37|-0.33|0.091
70951701|NCT01266161|141404301|SUPERIORITY||Least-squares means|14.95|||<|0.001|TWO_SIDED|95.0|9.12|20.79||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 0-24.||20.79|9.12|<0.001
70951702|NCT01266161|141404301|SUPERIORITY||Least-squares means|5.87||||0.01|TWO_SIDED|95.0|1.42|10.33||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 24-36.||10.33|1.42|0.010
70951703|NCT01266161|141404301|SUPERIORITY||Least-squares means|3.48||||0.004|TWO_SIDED|95.0|1.13|5.83||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 32-36.||5.83|1.13|0.004
70951704|NCT01266161|141404301|SUPERIORITY||Least-squares means|6.09||||0.006|TWO_SIDED|95.0|1.82|10.36||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 36-48.||10.36|1.82|0.006
70868881|NCT01663532|141223753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 8.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.5|-0.9|<.0001
70951705|NCT01266161|141404301|SUPERIORITY||Least-squares means|2.41||||0.042|TWO_SIDED|95.0|0.09|4.73||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 44-48.||4.73|0.09|0.042
70951706|NCT01266161|141404301|SUPERIORITY||Least-squares means|10.97||||0.004|TWO_SIDED|95.0|3.49|18.45||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 24-48.||18.45|3.49|0.004
70951707|NCT01266161|141404302|SUPERIORITY||Hazard Ratio (HR)|0.18|||<|0.001||95.0|0.1|0.34|||proportional hazards model|||||0.34|0.10|<0.001
70951708|NCT01266161|141404303|SUPERIORITY||Treatment Difference|-48.01|||<|0.001||95.0|-64.46|-31.56||p-Values from the Cochran-Mantel-Haenszel (CMH) test, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||During the first dosing interval (0 to 12 hours).||-31.56|-64.46|<0.001
70951709|NCT01266161|141404303|SUPERIORITY||Treatment Difference|-25.53|||<|0.001||95.0|-39.78|-11.28||p-Values from the CMH test, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||During the second dosing interval (12 to 24 hours).||-11.28|-39.78|<0.001
71143583|NCT04913610|141781084|OTHER||||||=|0.92||||||The p-value is for the pairwise comparison of Arm D to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.920
70951710|NCT01266161|141404303|SUPERIORITY||Treatment Difference|-24.05||||0.002||95.0|-38.93|-9.18||p-Values from the CMH test, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||During the third dosing interval (24 to 36 hours).||-9.18|-38.93|0.002
70951711|NCT01266161|141404303|SUPERIORITY||Treatment Difference|-13.6||||0.035||95.0|-26.41|-0.79||p-Values from the CMH test, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||During the fourth dosing interval (36 to 48 hours).||-0.79|-26.41|0.035
71143584|NCT04913610|141781085|OTHER||||||=|0.981||||||The p-value is for the pairwise comparison of Arm A to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.981
71143585|NCT04913610|141781085|OTHER||||||=|0.981||||||The p-value is for the pairwise comparison of Arm B to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.981
71143586|NCT04913610|141781085|OTHER||||||=|0.96||||||The p-value is for the pairwise comparison of Arm C to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.960
71143587|NCT04913610|141781085|OTHER||||||=|0.96||||||The p-value is for the pairwise comparison of Arm D to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.960
71143588|NCT04913610|141781086|OTHER||||||=|0.157||||||The p-value is for the pairwise comparison of Arm A to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.157
71143589|NCT04913610|141781086|OTHER||||||=|0.15||||||The p-value is for the pairwise comparison of Arm B to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.150
71143590|NCT04913610|141781086|OTHER||||||=|0.15||||||The p-value is for the pairwise comparison of Arm C to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.150
71143591|NCT04913610|141781086|OTHER||||||=|0.173||||||The p-value is for the pairwise comparison of Arm D to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.173
71143592|NCT04913610|141781087|OTHER||||||=|0.619||||||The p-value is for the pairwise comparison of Arm A to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.619
71143593|NCT04913610|141781087|OTHER||||||=|0.194||||||The p-value is for the pairwise comparison of Arm B to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.194
71143594|NCT04913610|141781087|OTHER||||||=|0.518||||||The p-value is for the pairwise comparison of Arm C to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.518
70951712|NCT01266161|141404303|SUPERIORITY||Treatment Difference|-48.01|||<|0.001||95.0|-64.42|-31.6||p-Values from the CMH test, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||During the study overall (0 to 48 hours).||-31.60|-64.42|<0.001
71143595|NCT04913610|141781087|OTHER||||||=|0.652||||||The p-value is for the pairwise comparison of Arm D to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.652
71143596|NCT04913610|141781088|OTHER||||||=|0.386||||||The p-value is for the pairwise comparison of Arm A to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.386
71143597|NCT04913610|141781088|OTHER||||||=|0.279||||||The p-value is for the pairwise comparison of Arm B to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.279
70951713|NCT01266161|141404303|SUPERIORITY||Cox proportional hazard models|0.086||||0.011|TWO_SIDED|95.0|0.01|0.57|||Andersen-Gill (AG)|||Time to First Dose Rescue Medication Over Entire Study Period (0-48 Hours)||0.57|0.01|0.011
70951714|NCT01266161|141404304|SUPERIORITY||Least squares means|0.84|||<|0.001||95.0|0.5|1.19||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 0.5 hours.||1.19|0.50|<0.001
70951715|NCT01266161|141404304|SUPERIORITY||Least squares means|1.53|||<|0.001||95.0|1.11|1.94||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1 hour.||1.94|1.11|<0.001
70951716|NCT01266161|141404304|SUPERIORITY||Least squares means|2.0|||<|0.001||95.0|1.56|2.44||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1.5 hours.||2.44|1.56|<0.001
70951717|NCT01266161|141404304|SUPERIORITY||Least squares means|2.29|||<|0.001||95.0|1.86|2.73||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 2 hours.||2.73|1.86|<0.001
70951718|NCT01266161|141404304|SUPERIORITY||Least squares means|2.18|||<|0.001||95.0|1.69|2.68||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 4 hours.||2.68|1.69|<0.001
70951719|NCT01266161|141404304|SUPERIORITY||Least squares means|0.92|||<|0.001||95.0|0.46|1.38||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA||Treatment difference (ibuprofen minus placebo) and corresponding 95% CI were calculated based on least-squares means from the ANOVA model.|Ibuprofen versus placebo at 6 hours.||1.38|0.46|<0.001
70951720|NCT01266161|141404304|SUPERIORITY||Least squares means|1.04|||<|0.001||95.0|0.54|1.54||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 8 hours.||1.54|0.54|<0.001
70951721|NCT01266161|141404304|SUPERIORITY||Least squares means|1.1|||<|0.001||95.0|0.59|1.6||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 10 hours.||1.60|0.59|<0.001
70951722|NCT01266161|141404304|SUPERIORITY||Least squares means|0.5||||0.052||95.0|0.0|1.01||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 12 hours.||1.01|-0.00|0.052
70951723|NCT01266161|141404305|SUPERIORITY||Least squares means|0.37|||<|0.001||95.0|0.16|0.59||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 0.5 hours.||0.59|0.16|<0.001
70951724|NCT01266161|141404305|SUPERIORITY||Least squares means|0.9|||<|0.001||95.0|0.63|1.18||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1 hour.||1.18|0.63|<0.001
70951725|NCT01266161|141404305|SUPERIORITY||Least squares means|1.22|||<|0.001||95.0|0.91|1.52||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1.5 hours.||1.52|0.91|<0.001
70951726|NCT01266161|141404305|SUPERIORITY||Least squares means|1.4|||<|0.001||95.0|1.1|1.71||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 2 hours.||1.71|1.10|<0.001
70951727|NCT01266161|141404305|SUPERIORITY||Least squares means|1.32|||<|0.001||95.0|0.97|1.67||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 4 hours.||1.67|0.97|<0.001
70951728|NCT01266161|141404305|SUPERIORITY||Least squares means|0.61|||<|0.001||95.0|0.3|0.91||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 6 hours.||0.91|0.30|<0.001
71143598|NCT04913610|141781088|OTHER||||||=|0.385||||||The p-value is for the pairwise comparison of Arm C to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.385
70868882|NCT01663532|141223753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.6||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 10.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.6|-1.1|<.0001
70868883|NCT01663532|141223754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.0006|TWO_SIDED|95.0|-2.1|-0.6|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 1.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.6|-2.1|0.0006
70951729|NCT01266161|141404305|SUPERIORITY||Least squares means|0.64|||<|0.001||95.0|0.31|0.97||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 8 hours.||0.97|0.31|<0.001
70951730|NCT01266161|141404305|SUPERIORITY||Least squares means|0.66|||<|0.001||95.0|0.36|0.97||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 10 hours.||0.97|0.36|<0.001
70951731|NCT01266161|141404305|SUPERIORITY||Least squares means|0.27||||0.089||95.0|-0.04|0.59||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 12 hours.||0.59|-0.04|0.089
70951732|NCT01266161|141404305|SUPERIORITY||Least squares means|1.0|||<|0.001||95.0|0.7|1.29||Ibuprofen versus placebo at 0.5 hours.|ANOVA|||Ibuprofen versus placebo at 16 hours.||1.29|0.70|<0.001
70951733|NCT01266161|141404305|SUPERIORITY||Least squares means|0.47||||0.004||95.0|0.15|0.78||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 20 hours.||0.78|0.15|0.004
70951734|NCT01266161|141404305|SUPERIORITY||Least squares means|0.04||||0.821||95.0|-0.28|0.35||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 24 hours.||0.35|-0.28|0.821
70951735|NCT01266161|141404305|SUPERIORITY||Least squares means|0.56||||0.001||95.0|0.23|0.9||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 28 hours.||0.90|0.23|0.001
70951736|NCT01266161|141404305|SUPERIORITY||Least squares means|0.62|||<|0.001||95.0|0.3|0.94||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 32 hours.||0.94|0.30|<0.001
70951737|NCT01266161|141404305|SUPERIORITY||Least squares means|0.25||||0.127||95.0|-0.07|0.57||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 36 hours.||0.57|-0.07|0.127
70951738|NCT01266161|141404305|SUPERIORITY||Least squares means|0.67|||<|0.001||95.0|0.35|1.0||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 40 hours.||1.00|0.35|<0.001
71143599|NCT04913610|141781088|OTHER||||||=|0.755||||||The p-value is for the pairwise comparison of Arm D to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.755
71143600|NCT01210716|141781090|NON_INFERIORITY_OR_EQUIVALENCE|If the lower 97.5% confidence limit on the mean of the paired differences is greater than -15% of the Control group mean (i.e., p-value \<=0.05), then the Test group will be considered non-inferior in the primary efficacy parameter to Control at the margin of 15%.|Mean Difference (Final Values)|6.69|STANDARD_DEVIATION|6.97|<|0.001|ONE_SIDED|95.0|4.0||||paired t-test|||A one-sample t-test on the mean of paired differences was used to evaluate the primary objective. Sample size was determined using historical data and the 95% chi-square upper confidence limit on the observed standard deviation of the paired differences. A minimum sample of 27 pairs was required to demonstrate the AMICUS procedure to be non-inferior to Spectra with a mean efficiency of plasma removal with a non-inferiority margin of 15% with at least 97.5% (one-sided) confidence and 90% power.|||4.0|<0.001
70951739|NCT01266161|141404305|SUPERIORITY||Least squares means|0.34||||0.036||95.0|0.02|0.67||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 44 hours.||0.67|0.02|0.036
70951740|NCT01266161|141404305|SUPERIORITY||Least squares means|0.26||||0.091||95.0|-0.04|0.56||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 48 hours.||0.56|-0.04|0.091
70868884|NCT01663532|141223754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.3|-1.3|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 2.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-1.3|-3.3|<.0001
70868885|NCT01663532|141223754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|||<|0.0001|TWO_SIDED|95.0|-4.3|-2.0|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 4.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-2.0|-4.3|<.0001
70868886|NCT01663532|141223754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8|||<|0.0001|TWO_SIDED|95.0|-5.1|-2.6|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 6.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-2.6|-5.1|<.0001
70868887|NCT01663532|141223754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|||<|0.0001|TWO_SIDED|95.0|-6.2|-3.4|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 8.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-3.4|-6.2|<.0001
70868888|NCT01663532|141223754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1|||<|0.0001|TWO_SIDED|95.0|-6.4|-3.7|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 10.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-3.7|-6.4|<.0001
70868889|NCT01663532|141223755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.0023|TWO_SIDED|95.0|-1.6|-0.3|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 1.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.3|-1.6|0.0023
70868890|NCT01663532|141223755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.0032|TWO_SIDED|95.0|-2.0|-0.4|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 2.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.4|-2.0|0.0032
70868891|NCT01663532|141223755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.0003|TWO_SIDED|95.0|-2.7|-0.8|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 4.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.8|-2.7|0.0003
70868892|NCT01663532|141223755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.3|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 6.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-1.3|-3.2|<.0001
70868893|NCT01663532|141223755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.7|-1.4|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 8.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-1.4|-3.7|<.0001
70868894|NCT01663532|141223755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8|||<|0.0001|TWO_SIDED|95.0|-4.1|-1.6|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 10.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-1.6|-4.1|<.0001
70868895|NCT01663532|141223756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|||<|0.0001|TWO_SIDED|95.0|4.1|10.1|||ANCOVA|ANCOVA model with treatment and pooled centers as factors and Baseline value as covariate for the comparison at other visits.|Difference in least square mean of change were derived from ANCOVA model.|Statistical analysis for Week 10.||10.1|4.1|<.0001
70868896|NCT01663532|141223757|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|CMH raw mean scores differ test (Van Elteren test) controlling for pooled centers.||Statistical analysis for Week 10. LOCF method were used in imputation of missing data.||||<.0001
70951741|NCT01266161|141404306|SUPERIORITY||Least squares means|1.22|||<|0.001||95.0|0.69|1.74||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 0.5 hours.||1.74|0.69|<0.001
70868897|NCT01663532|141223758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.7|||<|0.0001|TWO_SIDED|95.0|12.9|32.4|||Cochran-Mantel-Haenszel|CMH test controlling by region (pooled sites).||Statistical analysis for Week 10. LOCF method were used in imputation of missing data.||32.4|12.9|<.0001
70868898|NCT01513343|141223762|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|Multinomial logistic regression examined program effects on child BMI categories, controlling for child sex, age (months), \& BMI z-score at pretest.||||||<0.05
70868899|NCT01513343|141223763|SUPERIORITY||||||<|0.05||||||To control for type I errors, the critical P values for each assessment were determined with the unweighted Bonferroni method, dividing the critical value of P \< 0.05 by the number of comparisons conducted for a given assessment.|Mixed Models Analysis|||||||<0.05
70868900|NCT01749137|141223764|SUPERIORITY|P-value from a mixed-effects analysis of covariance model with treatment, visit and visit-by-treatment interaction as factors, baseline weight as a covariate, and participant as the random effect.|Treatment Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.58||0.059|TWO_SIDED|95.0|-2.27|0.04|||Mixed Model Repeated Measures (MMRM)|||||0.04|-2.27|0.059
70868901|NCT01749137|141223765|SUPERIORITY|P-value from a mixed-effects analysis of covariance model with treatment, visit and visit-by-treatment interaction as factors, baseline weight as a covariate, and participant as the random effect.|Treatment Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.66||0.079|TWO_SIDED|95.0|-2.48|0.14|||MMRM|||||0.14|-2.48|0.079
70868902|NCT01749137|141223766|SUPERIORITY|||||||0.513||||||P-values from a Cochran-Mantel-Haenszel (CMH) test, controlling for site and the stratification factor severely obese (yes/no).|Cochran-Mantel-Haenszel|||||||0.513
70868903|NCT01749137|141223774|SUPERIORITY|P-value from a mixed-effects analysis of covariance model with treatment, visit and visit-by-treatment interaction as factors, baseline weight as a covariate, and participant as the random effect.|Treatment Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.87||0.387|TWO_SIDED|95.0|-2.5|0.98|||MMRM|||||0.98|-2.50|0.387
70868904|NCT01749137|141223775|SUPERIORITY|||||||1||||||P-values from a Cochran-Mantel-Haenszel (CMH) test, controlling for site.|Cochran-Mantel-Haenszel|||||||1.000
70868905|NCT01153347|141223779|SUPERIORITY_OR_OTHER||LS mean|-0.9|STANDARD_ERROR_OF_MEAN|1.07||1|TWO_SIDED|95.0|-2.96|1.24||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.24|-2.96|1.000
70868906|NCT01153347|141223779|SUPERIORITY_OR_OTHER||LS mean|-0.6|STANDARD_ERROR_OF_MEAN|1.08||1|TWO_SIDED|95.0|-2.67|1.57|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.57|-2.67|1.000
70868907|NCT01153347|141223779|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|1.09||1|TWO_SIDED|95.0|-2.26|2.04|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.04|-2.26|1.000
70868908|NCT01153347|141223780|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01|STANDARD_ERROR_OF_MEAN|0.24||0.967|TWO_SIDED|95.0|0.64|1.6|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.60|0.64|0.967
70868909|NCT01153347|141223780|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.21||0.67|TWO_SIDED|95.0|0.57|1.43|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.43|0.57|0.670
70868910|NCT01153347|141223780|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87|STANDARD_ERROR_OF_MEAN|0.21||0.544|TWO_SIDED|95.0|0.54|1.38|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.38|0.54|0.544
70868911|NCT01153347|141223781|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91|STANDARD_ERROR_OF_MEAN|0.24||0.73|TWO_SIDED|95.0|0.55|1.53|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.53|0.55|0.730
70868912|NCT01153347|141223781|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89|STANDARD_ERROR_OF_MEAN|0.23||0.671|TWO_SIDED|95.0|0.53|1.5|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.50|0.53|0.671
70868913|NCT01153347|141223781|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76|STANDARD_ERROR_OF_MEAN|0.2||0.308|TWO_SIDED|95.0|0.45|1.29|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.29|0.45|0.308
70951742|NCT01266161|141404306|SUPERIORITY||Least squares means|2.43|||<|0.001||95.0|1.77|3.09||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1 hour.||3.09|1.77|<0.001
70868914|NCT01153347|141223782|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95|STANDARD_ERROR_OF_MEAN|0.4||0.905|TWO_SIDED|95.0|0.42|2.15|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.15|0.42|0.905
70868915|NCT01153347|141223782|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93|STANDARD_ERROR_OF_MEAN|0.39||0.864|TWO_SIDED|95.0|0.41|2.14|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.14|0.41|0.864
70868916|NCT01153347|141223782|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98|STANDARD_ERROR_OF_MEAN|0.42||0.958|TWO_SIDED|95.0|0.43|2.25|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.25|0.43|0.958
70868917|NCT01153347|141223783|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91|STANDARD_ERROR_OF_MEAN|0.3||0.778|TWO_SIDED|95.0|0.48|1.73|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.73|0.48|0.778
70868918|NCT01153347|141223783|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22|STANDARD_ERROR_OF_MEAN|0.38||0.532|TWO_SIDED|95.0|0.66|2.24|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.24|0.66|0.532
70868919|NCT01153347|141223783|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85|STANDARD_ERROR_OF_MEAN|0.29||0.633|TWO_SIDED|95.0|0.44|1.64|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.64|0.44|0.633
70868920|NCT01153347|141223784|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03|STANDARD_ERROR_OF_MEAN|0.42||0.949|TWO_SIDED|95.0|0.46|2.31|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.31|0.46|0.949
70868921|NCT01153347|141223784|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57|STANDARD_ERROR_OF_MEAN|0.62||0.253|TWO_SIDED|95.0|0.72|3.4|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||3.40|0.72|0.253
70868922|NCT01153347|141223784|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88|STANDARD_ERROR_OF_MEAN|0.39||0.763|TWO_SIDED|95.0|0.37|2.08|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.08|0.37|0.763
70868923|NCT01153347|141223785|SUPERIORITY_OR_OTHER||LS mean|-1.0|STANDARD_ERROR_OF_MEAN|0.78||0.207|TWO_SIDED|95.0|-2.51|0.55|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.55|-2.51|0.207
70868924|NCT01153347|141223785|SUPERIORITY_OR_OTHER||LS mean|-0.6|STANDARD_ERROR_OF_MEAN|0.78||0.427|TWO_SIDED|95.0|-2.16|0.91|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.91|-2.16|0.427
70868925|NCT01153347|141223785|SUPERIORITY_OR_OTHER||LS mean|-0.4|STANDARD_ERROR_OF_MEAN|0.78||0.591|TWO_SIDED|95.0|-1.96|1.12|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.12|-1.96|0.591
70868926|NCT01153347|141223786|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.551||95.0|-0.34|0.18|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.18|-0.34|0.551
70868927|NCT01153347|141223786|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.487|TWO_SIDED|95.0|-0.36|0.17|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.17|-0.36|0.487
70868928|NCT01153347|141223786|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.78|TWO_SIDED|95.0|-0.23|0.31|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.31|-0.23|0.780
70951743|NCT01266161|141404306|SUPERIORITY||Least squares means|3.22|||<|0.001||95.0|2.49|3.95||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1.5 hours.||3.95|2.49|<0.001
70951744|NCT01266161|141404306|SUPERIORITY||Least squares means|3.7|||<|0.001||95.0|2.98|4.42||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 2 hours.||4.42|2.98|<0.001
70868929|NCT01153347|141223787|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97|STANDARD_ERROR_OF_MEAN|0.23||0.908|TWO_SIDED|95.0|0.62|1.53|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||1.53|0.62|0.908
70868930|NCT01153347|141223787|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06|STANDARD_ERROR_OF_MEAN|0.24||0.803|TWO_SIDED|95.0|0.67|1.67|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||1.67|0.67|0.803
70868931|NCT01153347|141223787|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65|STANDARD_ERROR_OF_MEAN|0.15||0.066|TWO_SIDED|95.0|0.41|1.03|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||1.03|0.41|0.066
70868932|NCT01153347|141223788|SUPERIORITY_OR_OTHER||LS mean|-0.82|STANDARD_ERROR_OF_MEAN|0.645||0.202|TWO_SIDED|95.0|-2.091|0.442|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.442|-2.091|0.202
70868933|NCT01153347|141223788|SUPERIORITY_OR_OTHER||LS mean|-0.22|STANDARD_ERROR_OF_MEAN|0.647||0.738|TWO_SIDED|95.0|-1.487|1.055|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.055|-1.487|0.738
70868934|NCT01153347|141223788|SUPERIORITY_OR_OTHER||LS mean|-0.51|STANDARD_ERROR_OF_MEAN|0.65||0.433|TWO_SIDED|95.0|-1.787|0.767|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.767|-1.787|0.433
70868935|NCT01153347|141223789|SUPERIORITY_OR_OTHER||LS mean|1.0|STANDARD_ERROR_OF_MEAN|0.61||0.097|TWO_SIDED|95.0|-0.18|2.22|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.22|-0.18|0.097
70868936|NCT01153347|141223789|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.61||0.882|TWO_SIDED|95.0|-1.29|1.11|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.11|-1.29|0.882
70868937|NCT01153347|141223789|SUPERIORITY_OR_OTHER||LS mean|1.0|STANDARD_ERROR_OF_MEAN|0.62||0.1|TWO_SIDED|95.0|-0.19|2.23|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.23|-0.19|0.100
70868938|NCT01153347|141223790|SUPERIORITY_OR_OTHER||LS mean|0.8|STANDARD_ERROR_OF_MEAN|0.74||0.303|TWO_SIDED|95.0|-0.69|2.22|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.22|-0.69|0.303
70868939|NCT01153347|141223790|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.74||0.793|TWO_SIDED|95.0|-1.26|1.65|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.65|-1.26|0.793
70868940|NCT01153347|141223790|SUPERIORITY_OR_OTHER||LS mean|-0.2|STANDARD_ERROR_OF_MEAN|0.75||0.762|TWO_SIDED|95.0|-1.7|1.25|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.25|-1.70|0.762
70951745|NCT01266161|141404306|SUPERIORITY||Least squares means|3.5|||<|0.001||95.0|2.67|4.33||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 4 hours.||4.33|2.67|<0.001
70951746|NCT01266161|141404306|SUPERIORITY||Least squares means|1.53|||<|0.001||95.0|0.79|2.27||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 6 hours.||2.27|0.79|<0.001
70951747|NCT01266161|141404306|SUPERIORITY||Least squares means|1.67|||<|0.001||95.0|0.87|2.48||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 8 hours.||2.48|0.87|<0.001
70868941|NCT01153347|141223791|SUPERIORITY_OR_OTHER||LS mean|-0.9|STANDARD_ERROR_OF_MEAN|0.91||0.339|TWO_SIDED|95.0|-2.65|0.92|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.92|-2.65|0.339
70868942|NCT01153347|141223791|SUPERIORITY_OR_OTHER||LS mean|-0.9|STANDARD_ERROR_OF_MEAN|0.91||0.321|TWO_SIDED|95.0|-2.7|0.89|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.89|-2.70|0.321
70868943|NCT01153347|141223791|SUPERIORITY_OR_OTHER||LS mean|-0.4|STANDARD_ERROR_OF_MEAN|0.92||0.68|TWO_SIDED|95.0|-2.2|1.43|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.43|-2.20|0.680
70868944|NCT01153347|141223792|SUPERIORITY_OR_OTHER||LS mean|-0.3|STANDARD_ERROR_OF_MEAN|0.97||0.737|TWO_SIDED|95.0|-2.23|1.58|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects the model; pooled center is a random effect.||1.58|-2.23|0.737
70868945|NCT01153347|141223792|SUPERIORITY_OR_OTHER||LS mean|-0.6|STANDARD_ERROR_OF_MEAN|0.98||0.547|TWO_SIDED|95.0|-2.52|1.33|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.33|-2.52|0.547
70868946|NCT01153347|141223792|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.99||0.953|TWO_SIDED|95.0|-1.89|2.01|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.01|-1.89|0.953
70868947|NCT01153347|141223793|SUPERIORITY_OR_OTHER||LS mean|-0.6|STANDARD_ERROR_OF_MEAN|0.746||1|TWO_SIDED|95.0|-2.069|0.864||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.864|-2.069|1.000
70868948|NCT01153347|141223793|SUPERIORITY_OR_OTHER||LS mean|-0.52|STANDARD_ERROR_OF_MEAN|0.755||1|TWO_SIDED|95.0|-2.004|0.96||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.960|-2.004|1.000
70868949|NCT01153347|141223793|SUPERIORITY_OR_OTHER||LS mean|0.4|STANDARD_ERROR_OF_MEAN|0.761||1|TWO_SIDED|95.0|-1.095|1.896||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.896|-1.095|1.000
70868950|NCT01153347|141223794|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.29||0.953|TWO_SIDED|95.0|-0.56|0.59|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.59|-0.56|0.953
70868951|NCT01153347|141223794|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.868|TWO_SIDED|95.0|-0.64|0.54|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.54|-0.64|0.868
70868952|NCT01153347|141223794|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.792|TWO_SIDED|95.0|-0.5|0.66|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.66|-0.50|0.792
70868953|NCT01153347|141223795|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.915|TWO_SIDED|95.0|-0.54|0.48|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.48|-0.54|0.915
70868954|NCT01153347|141223795|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.972|TWO_SIDED|95.0|-0.51|0.53|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.53|-0.51|0.972
70868955|NCT01153347|141223795|SUPERIORITY_OR_OTHER||LS mean|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.237|TWO_SIDED|95.0|-0.21|0.84|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.84|-0.21|0.237
70951748|NCT01266161|141404306|SUPERIORITY||Least squares means|1.76|||<|0.001||95.0|0.97|2.54||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 10 hours.||2.54|0.97|<0.001
70868956|NCT01153347|141223796|SUPERIORITY_OR_OTHER||LS mean|-0.3|STANDARD_ERROR_OF_MEAN|0.27||0.213|TWO_SIDED|95.0|-0.87|0.19|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.19|-0.87|0.213
70868957|NCT01153347|141223796|SUPERIORITY_OR_OTHER||LS mean|-0.3|STANDARD_ERROR_OF_MEAN|0.27||0.343|TWO_SIDED|95.0|-0.8|0.28|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.28|-0.80|0.343
70868958|NCT01153347|141223796|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.28||0.971|TWO_SIDED|95.0|-0.55|0.53|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.53|-0.55|0.971
70868959|NCT01153347|141223797|SUPERIORITY_OR_OTHER||LS mean|2.1|STANDARD_ERROR_OF_MEAN|1.694||0.215|TWO_SIDED|95.0|-1.224|5.431|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||5.431|-1.224|0.215
70868960|NCT01153347|141223797|SUPERIORITY_OR_OTHER||LS mean|0.72|STANDARD_ERROR_OF_MEAN|1.702||0.673|TWO_SIDED|95.0|-2.624|4.062|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||4.062|-2.624|0.673
70868961|NCT01153347|141223797|SUPERIORITY_OR_OTHER||LS mean|-1.88|STANDARD_ERROR_OF_MEAN|1.716||0.275|TWO_SIDED|95.0|-5.248|1.494|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.494|-5.248|0.275
70868962|NCT01153347|141223798|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.412|TWO_SIDED|95.0|-0.28|0.11|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.11|-0.28|0.412
70868963|NCT01153347|141223798|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.928|TWO_SIDED|95.0|-0.19|0.21|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.21|-0.19|0.928
70868964|NCT01153347|141223798|SUPERIORITY_OR_OTHER||LS mean|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.033|TWO_SIDED|95.0|-0.42|-0.02|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||-0.02|-0.42|0.033
70868965|NCT01153347|141223799|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.353|TWO_SIDED|95.0|-0.1|0.28|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.28|-0.10|0.353
70868966|NCT01153347|141223799|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.721|TWO_SIDED|95.0|-0.16|0.23|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.23|-0.16|0.721
70868967|NCT01153347|141223799|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.666|TWO_SIDED|95.0|-0.24|0.15|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.15|-0.24|0.666
70868968|NCT01153347|141223800|SUPERIORITY_OR_OTHER||LS mean|-0.006|STANDARD_ERROR_OF_MEAN|0.0201||0.747|TWO_SIDED|95.0|-0.0459|0.0329||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0329|-0.0459|0.747
70868969|NCT01153347|141223800|SUPERIORITY_OR_OTHER||LS mean|-0.013|STANDARD_ERROR_OF_MEAN|0.0203||0.524|TWO_SIDED|95.0|-0.0529|0.027||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0270|-0.0529|0.524
70868970|NCT01153347|141223800|SUPERIORITY_OR_OTHER||LS mean|-0.014|STANDARD_ERROR_OF_MEAN|0.0206||0.502|TWO_SIDED|95.0|-0.0543|0.0267||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0267|-0.0543|0.502
70868971|NCT01153347|141223800|SUPERIORITY_OR_OTHER||LS mean|1.9|STANDARD_ERROR_OF_MEAN|2.06||0.345|TWO_SIDED|95.0|-2.1|6.0||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||6.00|-2.10|0.345
70951749|NCT01266161|141404306|SUPERIORITY||Least squares means|0.78||||0.056||95.0|-0.02|1.58||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 12 hours.||1.58|-0.02|0.056
70951750|NCT01266161|141404307|SUPERIORITY||Least squares means|14.82|||<|0.001|TWO_SIDED|95.0|10.38|19.25||p-Value from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 0 to 12 hours.||19.25|10.38|<0.001
70951751|NCT01266161|141404307|SUPERIORITY||Least squares means|5.27|||<|0.001|TWO_SIDED|95.0|2.57|7.98||p-Value from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo from 8 to 12 hours.||7.98|2.57|<0.001
70951752|NCT01266161|141404308|SUPERIORITY||CMH-adjusted proportion|-0.73|||<|0.001|TWO_SIDED|95.0|-0.91|-0.55||p-Values from the CMH test with modified ridit scores, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||For the first dosing interval.||-0.55|-0.91|<0.001
70951753|NCT01266161|141404308|SUPERIORITY||CMH-adjusted proportions|-0.72|||<|0.001|TWO_SIDED|95.0|-1.05|-0.4||Treatment difference (ibuprofen minus placebo) and corresponding 95% CI were calculated based on CMH-adjusted proportions and corresponding standard errors.|Cochran-Mantel-Haenszel|||For the second dosing interval.||-0.40|-1.05|<0.001
70951754|NCT01266161|141404308|SUPERIORITY||CMH-adjusted proportions|-0.48||||0.002|TWO_SIDED|95.0|-0.9|-0.06||p-Values from the CMH test with modified ridit scores, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||For the third dosing interval.||-0.06|-0.90|0.002
70951755|NCT01266161|141404308|SUPERIORITY||CMH-adjusted proportion|-0.68||||0.021|TWO_SIDED|95.0|-1.02|-0.35||p-Values from the CMH test with modified ridit scores, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||For the fourth dosing interval.||-0.35|-1.02|0.021
71143601|NCT02051764|141781108|OTHER|||||||0.2837||||||Not adjusted for multiple comparisons. No a priori threshold was selected.|ANCOVA|Adjustments included baseline tau deposition, age, time (in years) between imaging, and included an interaction of time and enrolling diagnosis.||Overall change from baseline between groups. Test compared slopes of cognitively impaired (CI) vs healthy volunteers (HV). As the time between scans varied across subjects, an ANCOVA model was used to estimate slopes in each diagnosis group and test whether they were the different at 1 year. The flortaucipir change from baseline was used as the dependent variable in the model.||||0.2837
71143602|NCT02051764|141781108|OTHER|||||||0.9276||||||Not adjusted for multiple comparisons. No a priori threshold was selected.|ANCOVA|Adjustments included baseline tau deposition, age, time (in years) between imaging, and included an interaction of time and enrolling diagnosis.||Change from baseline between groups for amyloid negative only. Test compared slopes of CI vs HV. As the time between scans varied across subjects, an ANCOVA model was used to estimate slopes in each diagnosis group and test whether they were different at 1 year. The flortaucipir change from baseline was used as the dependent variable in the model.||||0.9276
71143603|NCT02051764|141781108|OTHER|||||||0.6324||||||Not adjusted for multiple comparisons. No a priori threshold was selected.|ANCOVA|Adjustments included baseline tau deposition, age, time (in years) between imaging, and included an interaction of time and enrolling diagnosis.||Change from baseline between groups for amyloid positive only. Test compared slopes of CI vs HV. As the time between scans varied across subjects, an ANCOVA model was used to estimate slopes in each diagnosis group and test whether they were different at 1 year. The flortaucipir change from baseline was used as the dependent variable in the model.||||0.6324
71143604|NCT03155724|141781114|SUPERIORITY||||||<|0.0001|||||||Exact, binomial, one-sided|||The primary endpoint 1 hypothesis was evaluated by performing an exact, binomial test comparing the binomial proportion of 'improved' patients to 3.0% with power of 80% and type 1 error (alpha) of 0.0224. A pre-planned interim analysis at 45 patients required a type 1 error (alpha) of 0.0026 to demonstrate significance.||||<0.0001
71143605|NCT00321789|141781125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3||||0.44|TWO_SIDED|95.0|-3.6|8.3|||Mixed Models Analysis|Model was adjusted for a priori race and cardiovascular disease risk level strata.||||8.3|-3.6|0.44
71143606|NCT00321789|141781126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.03|TWO_SIDED|95.0|-0.23|-0.01|||Mixed Models Analysis|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.||||-0.01|-0.23|0.03
71143607|NCT00321789|141781127|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16||||0.02|TWO_SIDED|95.0|-0.29|-0.02|||Mixed Models Analysis|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.||||-0.02|-0.29|0.02
71143608|NCT00321789|141781128|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16||||0.02|TWO_SIDED|95.0|-0.29|-0.03|||Mixed Models Analysis|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.||||-0.03|-0.29|0.02
71143609|NCT00321789|141781129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.11|TWO_SIDED|95.0|-0.3|0.03|||Mixed Models Analysis|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.||||0.03|-0.30|0.11
71143610|NCT00321789|141781130|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.26|TWO_SIDED|95.0|-0.06|0.2|||Mixed Models Analysis|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.||||0.20|-0.06|0.26
71143611|NCT00321789|141781131|SUPERIORITY_OR_OTHER||incident rate ratio|1.2||||0.06|TWO_SIDED|95.0|1.0|1.5|||generalized estimating equations|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.||||1.5|1.0|0.06
71143612|NCT00321789|141781132|SUPERIORITY_OR_OTHER||incident rate ratio|1.1||||0.37|TWO_SIDED|95.0|0.9|1.4|||generalized estimating equations|Model adjusted for a priori race and cardiovascular disease risk category.||||1.4|0.9|0.37
71143613|NCT00321789|141781133|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.11||||0.04|TWO_SIDED|95.0|-4.13|-0.09|||Mixed Models Analysis|Model adjusted for a priori race and cardiovascular disease risk category.||||-0.09|-4.13|0.04
71143614|NCT00321789|141781134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64||||0.09|TWO_SIDED|95.0|-1.38|0.1|||Mixed Models Analysis|Model adjusted for a priori race and cardiovascular disease risk category.||||0.10|-1.38|0.09
71143615|NCT00321789|141781135|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.87|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|Model adjusted for a priori race and cardiovascular disease risk category.||||1.7|0.6|0.87
70951756|NCT01266161|141404308|SUPERIORITY||CMH-adjusted proportion|-0.7|||<|0.001|TWO_SIDED|95.0|-0.89|-0.51||p-Values from the CMH test with modified ridit scores, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||For the overall study duration.||-0.51|-0.89|<0.001
71143616|NCT02588599|141781138|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|t=8.0; df=53||||||<0.0001
71143617|NCT03309020|141781140|OTHER|||||||0.802||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment and gender (male or female) were included as covariates in the model||Null hypothesis is no difference in grade between survivor statuses one month after cataract surgery||||0.802
71143618|NCT03309020|141781141|OTHER|||||||0.713||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment and gender (male or female) were included as covariates in the model||Null hypothesis is no difference in grade between survivor statuses three months after cataract surgery||||.713
71143619|NCT03309020|141781142|OTHER||Odds Ratio (OR)|0.1|||||TWO_SIDED|95.0|0.01|0.69|||||Odds of eye with at least 20/40 best corrected visual acuity (BCVA) 12 months after cataract surgery for controls vs. EVD survivors|Null hypothesis is no difference in the proportion of participants with at least 20/40 best corrected visual acuity (BCVA) between survivor statuses||0.69|0.01|
71143620|NCT03309020|141781143|OTHER|||||||0.832||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment and gender (male or female) were included as covariates in the model||||||.832
71143621|NCT03309020|141781144|OTHER|||||||0.995||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment and gender (male or female) were included as covariates in the model||||||.995
71143622|NCT03309020|141781145|OTHER|||||||0.441||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment and gender (male or female) were included as covariates in the model||||||0.441
71143623|NCT03309020|141781146|OTHER|||||||0.892||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment, survivor status (EVD survivor/control) included as covariates; within-subject measurement of distinct eyes treated as independent||||||.892
71143624|NCT03309020|141781147|OTHER|||||||0.913||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment, survivor status (EVD survivor/control) included as covariates; within-subject measurement of distinct eyes treated as independent||||||.913
71143625|NCT03309020|141781148|OTHER|||||||0.106||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Gender (male/female), survivor status (EVD survivor/control) as covariates; within-subject measurement of distinct eyes treated as independent||||||.106
71143626|NCT03309020|141781149|OTHER|||||||0.09||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Gender (male/female), survivor status (EVD survivor/control) as covariates; within-subject measurement of distinct eyes treated as independent||||||0.09
71143627|NCT02919761|141781155|OTHER||||||=|0.242||||||At Week 4|One-sample binomial test|||||||=0.242
71143628|NCT02919761|141781155|OTHER||||||<|0.0001||||||At Week 8|One-sample binomial test|||||||<0.0001
71143629|NCT02919761|141781155|OTHER||||||<|0.0001|||||||One-sample binomial test|||||||<0.0001
71143630|NCT02919761|141781156|OTHER||||||=|0.313||||||Comparison at Week 12|Pearson's Chi-square test|||||||=0.313
71143631|NCT02919761|141781156|OTHER||||||=|0.439||||||Comparison at Week 16|Pearson's Chi-square test|||||||=0.439
71143632|NCT02919761|141781156|OTHER||||||=|0.028||||||Comparison at Week 20|Pearson's Chi-square test|||||||=0.028
71143633|NCT02919761|141781156|OTHER||||||=|0.019||||||Comparison at Week 24|Pearson's Chi-square test|||||||=0.019
71143634|NCT03349723|141781173|OTHER||Slope|0.9806|STANDARD_ERROR_OF_MEAN|0.0322|||TWO_SIDED|95.0|0.9155|1.0457|||||Based on the estimate for the slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|The model consisted of a regression model applied to log-transformed data. The corresponding ANCOVA model included the logarithm of the dose as a covariate.||1.0457|0.9155|
71143635|NCT03349723|141781174|OTHER||Slope|0.9892|STANDARD_ERROR_OF_MEAN|0.0339|||TWO_SIDED|95.0|0.9207|1.0577|||||Based on the estimate for the slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|The model consisted of a regression model applied to log-transformed data. The corresponding ANCOVA model included the logarithm of the dose as a covariate.||1.0577|0.9207|
71143636|NCT03409796|141781179|OTHER|||||||0.385|||||||t-test, 1 sided|||Gluten 3 gram: Baseline versus Day 15. Change in Vh:Cd follows a normal distribution. A 1-sided paired t-test was used to compare Baseline and follow-up Vh:Cd measures. The normality assumption was checked using the Shapiro-Wilk test. If the data was not normal at alpha=0.05, a 1-sided Wilcoxon signed-rank test was used instead to compare Vh:CdBaseline (B) and Vh:Cd15.||||0.385
71143637|NCT03409796|141781179|OTHER|||||||0.003|||||||t-test, 1 sided|||Gluten 10 gram: Baseline versus Day 15. Change in Vh:Cd follows a normal distribution. A 1-sided paired t-test was used to compare Baseline and follow-up Vh:Cd measures. The normality assumption was checked using the Shapiro-Wilk test. If the data was not normal at alpha=0.05, a 1-sided Wilcoxon signed-rank test was used instead to compare Vh:CdB and Vh:Cd15.||||0.003
71143638|NCT03409796|141781180|OTHER|||||||0.01|||||||Poisson distribution|||Gluten 3 gram: Baseline versus Day 15. The Poisson distribution assumption was checked using Kolmogorov-Smirnov test. Poisson generalized linear mixed models (GLMM) was fitted to data, where IEL measurements were grouped by participant (the random effect) and the change in IEL counts was the fixed effect. If the data was found to not be Poisson at alpha=0.05, a 1-sided Wilcoxon signed-rank test was used instead to compare IELB and IEL15.||||0.010
70868972|NCT01153347|141223800|SUPERIORITY_OR_OTHER||LS mean|1.5|STANDARD_ERROR_OF_MEAN|2.09||0.486|TWO_SIDED|95.0|-2.65|5.56||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||5.56|-2.65|0.486
70868973|NCT01153347|141223800|SUPERIORITY_OR_OTHER||LS mean|-1.2|STANDARD_ERROR_OF_MEAN|2.12||0.564|TWO_SIDED|95.0|-5.39|2.94||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.94|-5.39|0.564
71143639|NCT03409796|141781180|OTHER|||||||0.006|||||||Poisson distribution|||Gluten 10 gram: Baseline versus Day 15. The Poisson distribution assumption was checked using Kolmogorov-Smirnov test. Poisson GLMM was fitted to data, where IEL measurements were grouped by participant (the random effect) and the change in IEL counts was the fixed effect. If the data was found to not be Poisson at alpha=0.05, a 1-sided Wilcoxon signed-rank test was used instead to compare IELB and IEL15.||||0.006
71143640|NCT01602224|141781196|SUPERIORITY||Odds Ratio (OR)|1.98||||0.401|TWO_SIDED||||||Regression, Logistic|||100 mg Tabalumab+Dexamethasone+Bortezomib compared with Placebo Comparator: Placebo + Dexamethasone + Bortezombib, only tabalumab odds ratio compared to placebo.||||0.401
71143641|NCT01602224|141781196|SUPERIORITY||Odds Ratio (OR)|1.84||||0.455|TWO_SIDED||||||Regression, Logistic|||300 mg Tabalumab+Dexamethasone+Bortezomib compared with Placebo Comparator: Placebo + Dexamethasone + Bortezombib, only tabalumab odds ratio compared to placebo.||||0.455
71143642|NCT01602224|141781196|SUPERIORITY||Odds Ratio (OR)|1.9||||0.419|TWO_SIDED||||||Regression, Logistic|||100 mg Tabalumab+Dexamethasone+Bortezomib and 300 mg Tabalumab+Dexamethasone+Bortezomib compared with Placebo Comparator: Placebo + Dexamethasone + Bortezombib, only compared to placebo.||||0.419
71143643|NCT01352117|141781198|SUPERIORITY|||||||0.911||||||The critical value for the final analysis was adjusted for the three interim analyses conducted for the Data and Safety Monitoring Board (DSMB) review using the Haybittle-Peto guidelines, at the p-value cutoff of 0.0487.|Wilcoxon (Mann-Whitney)|Stratified Wilcoxon-Mann-Whitney test (asymptotic method) known as van Elteren test, stratification by screening CD4 (\<200 vs. \>=200 cells/mm\^3).||||||0.911
71143644|NCT00770653|141781237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.267||||0.0018|TWO_SIDED|95.0|1.2264|5.3076|||ANCOVA|||Null hypothesis (H0) = mean increase of HDL after 24 weeks of treatment of Pio/Met group ≤ the mean increase in the Gli/Met group. Alternate hypothesis (H1) = mean increase of HDL after 24 weeks of treatment of Pio/Met group \> the mean increase in the Gli/Met group. The relevant clinical effect size to detect with adequate power was 0.35. With this assumption, a one sided t-test with a type I error rate had 80% power to reject the H0 for the H1 when the sample size was 130 patients per group.||5.3076|1.2264|0.0018
71143645|NCT00770653|141781238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.267||||0.0018|TWO_SIDED|95.0|1.2264|5.3076|||ANCOVA||Deviation from the normal distribution assumption was detected for original and rank-transformed data for all time-points due to p-value of Shapiro-Wilk test, indicating the normal distribution assumption might be distrusted for HDL-cholesterol data.|||5.3076|1.2264|0.0018
71143646|NCT00770653|141781239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1311||||0.1167|TWO_SIDED|95.0|-0.2951|0.0329|||ANCOVA|||||0.0329|-0.2951|0.1167
71143647|NCT00770653|141781240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.9479||||0.1012|TWO_SIDED|95.0|-39.4331|3.5373|||ANCOVA|||||3.5373|-39.4331|0.1012
71143648|NCT00770653|141781241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1292||||0.7486|TWO_SIDED|95.0|-17.0109|23.2693|||ANCOVA|||||23.2693|-17.0109|0.7486
71143649|NCT00770653|141781242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2355||||0.9464|TWO_SIDED|95.0|-7.1253|6.6543|||ANCOVA|||||6.6543|-7.1253|0.9464
71143650|NCT00770653|141781243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1574||||0.0807|TWO_SIDED|95.0|-0.0193|0.3341|||ANCOVA|||||0.3341|-0.0193|0.0807
71143651|NCT00770653|141781244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5039|||<|0.0001|TWO_SIDED|95.0|-6.4222|-2.5855|||ANCOVA|||||-2.5855|-6.4222|<.0001
71143652|NCT00770653|141781245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0707||||0.7799|TWO_SIDED|95.0|-6.4665|8.6079|||ANCOVA|||||8.6079|-6.4665|0.7799
71143653|NCT00770653|141781246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3161|||<|0.0001|TWO_SIDED|95.0|5.0994|7.5329|||ANCOVA|||||7.5329|5.0994|<.0001
71143654|NCT00770653|141781247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8323||||0.4131|TWO_SIDED|95.0|-2.8312|1.1665|||ANCOVA|||||1.1665|-2.8312|0.4131
71143655|NCT00770653|141781248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8847|||<|0.0001|TWO_SIDED|95.0|-1.3067|-0.4627|||ANCOVA|||||-0.4627|-1.3067|<.0001
71143656|NCT00770653|141781249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4903||||0.0929|TWO_SIDED|95.0|-5.3979|0.4172|||ANCOVA|||||0.4172|-5.3979|0.0929
71143657|NCT00770653|141781250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8832||||0.3279|TWO_SIDED|95.0|-2.6571|0.8906|||ANCOVA|||||0.8906|-2.6571|0.3279
71143658|NCT00770653|141781251|SUPERIORITY_OR_OTHER||Fisher Exact|-3.33||||0.2895|TWO_SIDED|95.0|-14.83|8.39|||Fisher Exact|||The number and percentage of participants with a calculated compliance \>80% and \<120% are presented for both treatment groups. In addition, the p-values of Fisher's exact test, the two-sided 95% confidence intervals for the percentage of patients per treatment group and for the difference between the treatment groups are provided.||8.39|-14.83|0.2895
71143659|NCT00770653|141781252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.9516||||0.3517|TWO_SIDED|95.0|-94.1999|34.2967|||ANCOVA|||||34.2967|-94.1999|0.3517
71143660|NCT00770653|141781253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-151.4477||||0.1979|TWO_SIDED|95.0|-386.2256|83.3302|||ANCOVA|||||83.3302|-386.2256|0.1979
71143661|NCT00770653|141781254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.8589||||0.7186|TWO_SIDED|95.0|-163.3229|113.6052|||ANCOVA|||||113.6052|-163.3229|0.7186
71143662|NCT00770653|141781255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.9728||||0.5058|TWO_SIDED|95.0|-39.9915|20.0459|||ANCOVA|||||20.0459|-39.9915|0.5058
71143663|NCT00770653|141781256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.3988||||0.523|TWO_SIDED|95.0|-60.7193|117.5169|||ANCOVA|||||117.5169|-60.7193|0.5230
71143664|NCT00770653|141781257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-367.2639||||0.2203|TWO_SIDED|95.0|-964.3923|229.8646|||ANCOVA|||||229.8646|-964.3923|0.2203
70951757|NCT01266161|141404311|SUPERIORITY||Gamma statistic|0.85|||<|0.001|TWO_SIDED|95.0|0.74|0.95||p-Value from the CMH test with modified ridit scores, controlling for baseline PSR score and gender.|Cochran-Mantel-Haenszel|||Ibuprofen versus placebo at 24 hours||0.95|0.74|<0.001
70868974|NCT01153347|141223801|SUPERIORITY_OR_OTHER||LS mean|-1.4|STANDARD_ERROR_OF_MEAN|1.55||0.35|TWO_SIDED|95.0|-4.48|1.59|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SIS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.59|-4.48|0.350
70868975|NCT01153347|141223801|SUPERIORITY_OR_OTHER||LS mean|-1.3|STANDARD_ERROR_OF_MEAN|1.56||0.393|TWO_SIDED|95.0|-4.41|1.73|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SIS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.73|-4.41|0.393
70951758|NCT01266161|141404311|SUPERIORITY||Gamma statistic|0.79|||<|0.001|TWO_SIDED|95.0|0.66|0.92|||Cochran-Mantel-Haenszel|p-Value from the CMH test with modified ridit scores, controlling for baseline PSR score and gender.||Ibuprofen versus placebo at 48 hours||0.92|0.66|<0.001
70951759|NCT01602510|141404360|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.86|||=|0.438|TWO_SIDED|95.0|0.59|1.25|||Regression, Cox||p value with Treatment Group as covariate|||1.25|0.59|=0.438
70951760|NCT01602510|141404360|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.86|||=|0.212|TWO_SIDED|95.0|0.59|1.25|||Regression, Cox||p value with Site as covariate|||1.25|0.59|=0.212
71143665|NCT00770653|141781258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.0794||||0.585|TWO_SIDED|95.0|-95.6468|151.8057|||ANCOVA|||||151.8057|-95.6468|0.5850
71143666|NCT00770653|141781259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4205||||0.0138|TWO_SIDED|95.0|-4.3207|-0.5202|||ANCOVA|||||-0.5202|-4.3207|0.0138
71143667|NCT00770653|141781260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0009||||0.0817|TWO_SIDED|95.0|-30.1139|1.8578|||ANCOVA|||||1.8578|-30.1139|0.0817
71143668|NCT00770653|141781261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9935||||0.1761|TWO_SIDED|95.0|-0.4843|2.4712|||ANCOVA|||||2.4712|-0.4843|0.1761
71143669|NCT00770653|141781262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5263||||0.0002|TWO_SIDED|95.0|1.3832|3.6695|||ANCOVA|||||3.6695|1.3832|0.0002
71143670|NCT00770653|141781263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2345||||0.0055|TWO_SIDED|95.0|1.0675|5.4016|||ANCOVA|||||5.4016|1.0675|0.0055
71143671|NCT00770653|141781264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9712||||0.0264|TWO_SIDED|95.0|0.3863|5.5562|||ANCOVA|||||5.5562|0.3863|0.0264
71143672|NCT00770653|141781265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5394||||0.0509|TWO_SIDED|95.0|-0.0114|5.0901|||ANCOVA|||||5.0901|-0.0114|0.0509
71143673|NCT00770653|141781266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1718||||0.1013|TWO_SIDED|95.0|-0.466|4.8097|||ANCOVA|||||4.8097|-0.4660|0.1013
71143674|NCT00770653|141781267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1346||||0.1363|TWO_SIDED|95.0|-0.7338|5.0031|||ANCOVA|||||5.0031|-0.7338|0.1363
71143675|NCT00770653|141781268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4181||||0.1165|TWO_SIDED|95.0|-0.6561|5.4922|||ANCOVA|||||5.4922|-0.6561|0.1165
71143676|NCT04906499|141781274|OTHER||Cohen's d effect size|0.13|||||TWO_SIDED|95.0|-0.68|0.93||||||||0.93|-0.68|
71143677|NCT04906499|141781276|OTHER||Cohen's d effect size|0.42|||||TWO_SIDED|95.0|-0.44|1.24||||||||1.24|-0.44|
71143678|NCT04906499|141781278|OTHER||Cohen's d effect size|0.85|||||TWO_SIDED|95.0|-0.13|1.77||||||||1.77|-0.13|
71143679|NCT04906499|141781280|OTHER||Cohen's d effect size|0.97|||||TWO_SIDED|95.0|-0.05|1.93||||||||1.93|-0.05|
71143680|NCT04906499|141781282|OTHER||Pearson's r Correlation Coefficient|0.32|||||TWO_SIDED|95.0|-0.67|0.9||||||||0.90|-0.67|
71143681|NCT04906499|141781283|OTHER||Pearson's r Correlation Coefficient|0.55|||||TWO_SIDED|95.0|-0.48|0.94||||||||0.94|-0.48|
71143682|NCT04906499|141781284|OTHER||Pearson's r Correlation Coefficient|0.23|||||TWO_SIDED|95.0|-0.88|0.71||||||||0.71|-0.88|
71143683|NCT04906499|141781285|OTHER||Pearson's r Correlation Coefficient|-0.19|||||TWO_SIDED|95.0|-0.87|0.73||||||||0.73|-0.87|
71143684|NCT04906499|141781287|OTHER||Cohen's d effect size|-0.42|||||TWO_SIDED|95.0|-1.24|0.44||||||||0.44|-1.24|
71143685|NCT02722564|141781291|OTHER||||||<|0.001||||||p value associated with the change between estimated and actual BrAC when the participants BrAC was ascending to 0.1.|t-test, 2 sided|||||||<0.001
71143686|NCT02722564|141781291|OTHER||||||<|0.0001||||||p value associated with change between estimated and actual BrAC as participants BrAC descended to 0.08.|t-test, 2 sided|||||||<0.0001
71143687|NCT03525444|141781295|SUPERIORITY||Least Squares (LS) Mean Difference|13.8|||<|0.0001|TWO_SIDED|95.0|12.1|15.4|||Mixed-effects model for repeated measure|||The data presented for Primary endpoint was based on interim analysis at Week 4.||15.4|12.1|<0.0001
71143688|NCT03525444|141781296|SUPERIORITY||LS Mean Difference|14.3|||<|0.0001|TWO_SIDED|95.0|12.7|15.8|||Mixed-effects model for repeated measure|||||15.8|12.7|<0.0001
71143689|NCT03525444|141781297|SUPERIORITY||Rate ratio|0.37|||<|0.0001|TWO_SIDED|95.0|0.25|0.55|||Negative binomial regression model|||||0.55|0.25|<0.0001
71143690|NCT03525444|141781298|SUPERIORITY||LS Mean Difference|-41.8|||<|0.0001|TWO_SIDED|95.0|-44.4|-39.3|||Mixed-effects model for repeated measure|||||-39.3|-44.4|<0.0001
71143691|NCT03525444|141781299|SUPERIORITY||LS Mean Difference|20.2|||<|0.0001|TWO_SIDED|95.0|17.5|23.0|||Mixed-effects model for repeated measure|||||23.0|17.5|<0.0001
71143692|NCT03525444|141781300|SUPERIORITY||LS Mean Difference|1.04|||<|0.0001|TWO_SIDED|95.0|0.85|1.23|||Mixed-effects model for repeated measure|||||1.23|0.85|<0.0001
71143693|NCT03525444|141781301|SUPERIORITY||LS Mean Difference|-41.2|||<|0.0001|TWO_SIDED|95.0|-44.0|-38.5|||Mixed-effects model for repeated measure|||||-38.5|-44.0|<0.0001
71143694|NCT03525444|141781302|SUPERIORITY||LS Mean Difference|20.1|||<|0.0001|TWO_SIDED|95.0|16.9|23.2|||Mixed-effects model for repeated measure|||||23.2|16.9|<0.0001
71143695|NCT03525444|141781304|SUPERIORITY||LS Mean Difference|0.3|||||TWO_SIDED|95.0|0.17|0.43||||||||0.43|0.17|
71143696|NCT03525444|141781305|SUPERIORITY||LS Mean Difference|2.9|||||TWO_SIDED|95.0|2.3|3.4||||||||3.4|2.3|
71143697|NCT01959503|141781340|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank-Sum Test|||||||<0.0001
71143698|NCT01959503|141781341|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.0|||<|0.0001|TWO_SIDED|95.0|4.07|19.89|||Regression, Logistic|||||19.89|4.07|<0.0001
71143699|NCT01959503|141781342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.69|||<|0.0001|TWO_SIDED|95.0|3.27|18.11|||Regression, Logistic|||||18.11|3.27|<0.0001
71143700|NCT01600326|141781348|OTHER|Pair-wise comparison at Time point 1 compared to baseline|||||<|0.0001||||||One way repeated measure analysis of variance for outcome of total pain score over time adjusted for treatment with post hoc Tukey correction to adjust for multiple comparison|Tukey|See comments on P value||||||<0.0001
70951761|NCT01602510|141404360|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.86|||=|0.724|TWO_SIDED|95.0|0.59|1.25|||Regression, Cox||p value with CGI-S Baseline Score as covariate|||1.25|0.59|=0.724
70951762|NCT01602510|141404361|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.95|||=|0.869|TWO_SIDED|95.0|0.55|1.66|||Regression, Cox||p value with Treatment Group as covariate|||1.66|0.55|=0.869
70951763|NCT01602510|141404361|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.95|||=|0.061|TWO_SIDED|95.0|0.55|1.66|||Regression, Cox||p value with Site as covariate|||1.66|0.55|=0.061
70951764|NCT01602510|141404361|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.95|||=|0.505|TWO_SIDED|95.0|0.55|1.66|||Regression, Cox||p value with CGI-S Baseline Score as covariate|||1.66|0.55|=0.505
70951765|NCT01602510|141404362|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.79|||=|0.369|TWO_SIDED|95.0|0.48|1.32|||Regression, Cox||p value with Treatment Group as covariate|||1.32|0.48|=0.369
70951766|NCT01602510|141404362|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.79|||=|0.955|TWO_SIDED|95.0|0.48|1.32|||Regression, Cox||p value with Site as covariate|||1.32|0.48|=0.955
70951767|NCT01602510|141404362|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.79|||=|0.874|TWO_SIDED|95.0|0.48|1.32|||Regression, Cox||p value with CGI-S Baseline Score as covariate|||1.32|0.48|=0.874
70951768|NCT01602510|141404363|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|1.02|||=|0.927|TWO_SIDED|95.0|0.73|1.4|||Regression, Cox||p value with Treatment Group as covariate|||1.40|0.73|=0.927
70951769|NCT01602510|141404363|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|1.02|||=|0.036|TWO_SIDED|95.0|0.73|1.4|||Regression, Cox||p value with Site as covariate|||1.40|0.73|=0.036
70951770|NCT01602510|141404363|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|1.02|||=|0.509|TWO_SIDED|95.0|0.73|1.4|||Regression, Cox||p value with CGI-S Baseline Score as covariate|||1.40|0.73|=0.509
70951771|NCT01602510|141404364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||=|0.833|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||||0.5|-0.4|=0.833
70951772|NCT01602510|141404365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||=|0.245|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|=0.245
70951773|NCT01602510|141404366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|||=|0.155|TWO_SIDED|95.0|-3.0|0.5|||ANCOVA|||||0.5|-3.0|=0.155
70951774|NCT01602510|141404367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||=|0.661|TWO_SIDED|95.0|-1.4|2.2|||ANCOVA|||||2.2|-1.4|= 0.661
71143701|NCT01600326|141781348|SUPERIORITY||||||<|0.0001||||||One way repeated measure analysis of variance for outcome of total pain score over time adjusted for treatment with post hoc Tukey correction to adjust for multiple comparison|Tukey|||One way repeated measure analysis of variance for outcome of total pain score over time adjusted for treatment with post hoc Tukey correction to adjust for multiple comparison||||<0.0001
70951775|NCT01602510|141404368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||=|0.945|TWO_SIDED|95.0|-3.7|3.5|||ANCOVA|||||3.5|-3.7|= 0.945
70951776|NCT01602510|141404369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|||=|0.047|TWO_SIDED|95.0|-1.66|-0.01|||ANCOVA|||||-0.01|-1.66|=0.047
70951777|NCT05262751|141404370|OTHER||gMean Ratio|16.69|||||TWO_SIDED|90.0|7.28|38.24|||||gMean Ratio: MR1-1/R. Intra-individual Geometric coefficient of variation \[%\] = 34.1|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||38.24|7.28|
70951778|NCT05262751|141404370|OTHER||gMean Ratio|13.54|||||TWO_SIDED|90.0|8.1|22.64|||||gMean Ratio: MR1-2/R. Intra-individual Geometric coefficient of variation \[%\] = 34.1|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||22.64|8.10|
70951779|NCT05262751|141404370|OTHER||gMean Ratio|41.8|||||TWO_SIDED|90.0|34.24|51.04|||||gMean Ratio: MR2-1/R. Intra-individual Geometric coefficient of variation \[%\] = 28.4|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||51.04|34.24|
70951780|NCT05262751|141404370|OTHER||gMean Ratio|42.91|||||TWO_SIDED|90.0|34.9|52.76|||||gMean Ratio: MR2-2/R. Intra-individual Geometric coefficient of variation \[%\] = 28.4|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||52.76|34.90|
70951781|NCT05262751|141404371|OTHER||gMean Ratio|9.36|||||TWO_SIDED|90.0|5.91|14.8|||||gMean Ratio: MR1-1/R. Intra-individual Geometric coefficient of variation \[%\] = 44.8|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||14.80|5.91|
70951782|NCT05262751|141404371|OTHER||gMean Ratio|12.41|||||TWO_SIDED|90.0|7.93|19.43|||||gMean Ratio: MR1-2/R. Intra-individual Geometric coefficient of variation \[%\] = 44.8|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||19.43|7.93|
70951783|NCT05262751|141404371|OTHER||gMean Ratio|37.9|||||TWO_SIDED|90.0|29.25|49.11|||||gMean Ratio: MR2-1/R. Intra-individual Geometric coefficient of variation \[%\] = 40.4|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||49.11|29.25|
70951784|NCT05262751|141404371|OTHER||gMean Ratio|35.89|||||TWO_SIDED|90.0|27.66|46.55|||||gMean ratio: MR2-2/R. Intra-individual Geometric coefficient of variation \[%\] = 40.4|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||46.55|27.66|
70951785|NCT05262751|141404372|OTHER||gMean Ratio|12.09|||||TWO_SIDED|90.0|6.73|21.71|||||gMean Ratio: MR1-1/R. Intra-individual Geometric coefficient of variation \[%\] = 58.8|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||21.71|6.73|
71143702|NCT01600326|141781349|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>.99
71143703|NCT03224130|141781357|SUPERIORITY|||||||0.21|||||||Regression, Logistic|||||||0.21
71143704|NCT03224130|141781358|SUPERIORITY|||||||0.31|||||||Regression, Linear|||||||0.31
71143705|NCT03224130|141781359|SUPERIORITY|||||||0.24|||||||censored Poisson model|||||||0.24
71143706|NCT03224130|141781360|SUPERIORITY||||||<|0.01|||||||Poisson model|||||||<0.01
71143707|NCT03224130|141781361|SUPERIORITY|||||||0.5|||||||Regression, Logistic|||||||0.50
71143708|NCT03224130|141781362|SUPERIORITY|||||||0.998|||||||Regression, Logistic|||||||0.998
71143709|NCT03224130|141781363|SUPERIORITY|||||||0.92|||||||Regression, Logistic|||||||0.92
71143710|NCT01751061|141781390|SUPERIORITY|To test the primary hypothesis, we used a general linear model fit with generalized estimating equations, a linear link, and an exchangeable correlation (PROC GENMOD). Model parameters included indictor variables for intervention, Interview 2, the interaction between intervention and Interview 2, and a 4-level site variable. The mean CSCS between-groups difference, corresponding 95% confidence interval (CI), and p value were derived from the intervention-by-Interview 2 interaction term.|||||<|0.05||||||P values were calculated. A two-sided type-I error rate of 0.05 was set for all tests; there were no adjustments for multiple comparisons. All participants were included in analyses as per their group randomization.|GEE|||We estimated that 210 patients (315 surrogates, assuming \~1.5 per patient) would provide a power of 80% to detect a between-groups mean CSCS score difference of 9 percentage points between Interviews 1 and 2, assuming a baseline mean of 50, SD=24, a type-I error=5%, a correlation between interviews of 0.5, an expectation that 50% of patients would have multiple surrogates, an intraclass correlation coefficient of 0.8 for multiple surrogates for a patient, and 5% dropout before Interview 2.||||<0.05
71143711|NCT01751061|141781391|SUPERIORITY||||||<|0.05||||||P values were calculated.|generalized linear model|||Generalized linear model.||||<0.05
71143712|NCT01751061|141781392|SUPERIORITY||||||<|0.05||||||P values were calculated.|generalized linear model|||||||<0.05
71143713|NCT01751061|141781393|SUPERIORITY||||||<|0.05||||||P values were calculated.|generalized linear models|||||||<0.05
71143714|NCT01751061|141781394|SUPERIORITY||||||<|0.05||||||P values were calculated.|generalized linear models|||||||<0.05
71143715|NCT01751061|141781395|SUPERIORITY||||||<|0.05||||||P values were calculated.|generalized linear models|||||||<0.05
71143716|NCT01751061|141781396|SUPERIORITY||||||<|0.05||||||P values were calculated.|GEE|||To test the hypothesis, we used a general linear model fit with generalized estimating equations, a linear link, and an exchangeable correlation (PROC GENMOD). Model parameters included indictor variables for intervention, Interview 2, the interaction between intervention and Interview 2, and a 4-level site variable. The mean CSCS between-groups difference, corresponding 95% confidence interval (CI), and p value were derived from the intervention-by-Interview 2 interaction term.||||<0.05
71143717|NCT01194830|141781399|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.16||0.0005||95.0|-0.91|-0.26|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and number of other Oral Antidiabetic Drugs||||-0.26|-0.91|0.0005
71143718|NCT01194830|141781400|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.62|-0.22|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and number of other Oral Antidiabetic Drugs||||-0.22|-0.62|<0.0001
71143719|NCT01194830|141781401|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.15||0.0002||95.0|-0.84|-0.26|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and number of other Oral Antidiabetic Drugs||||-0.26|-0.84|0.0002
71143720|NCT01194830|141781402|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.15||0.0003||95.0|-0.85|-0.26|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and number of other Oral Antidiabetic Drugs||||-0.26|-0.85|0.0003
71143721|NCT01194830|141781403|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.063||||0.001|TWO_SIDED|95.0|1.764|9.358|||Regression, Logistic|||||9.358|1.764|0.0010
71143722|NCT01194830|141781404|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.433||||0.0352|TWO_SIDED|95.0|1.124|26.26|||Regression, Logistic|||||26.260|1.124|0.0352
71143723|NCT01194830|141781405|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.951||||0.0003|TWO_SIDED|95.0|1.651|5.274|||Regression, Logistic|||||5.274|1.651|0.0003
71143724|NCT01194830|141781406|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|7.2||0.0972||95.0|-26.1|2.2|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline FPG, and number of other Oral Antidiabetic Drugs||||2.2|-26.1|0.0972
71143725|NCT01194830|141781407|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.97|STANDARD_ERROR_OF_MEAN|24.45||0.9368||95.0|-53.8|49.86|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline 2-hour PPG, and number of other Oral Antidiabetic Drugs||||49.86|-53.80|0.9368
71143726|NCT00910104|141781471|SUPERIORITY||Hazard Ratio (HR)|8.6|||=|0.001|TWO_SIDED|95.0|2.0|37.3||All P-values were 2-sided. Analyses were performed in SAS 9.1 (SAS Institute, USA) and S-plus 8 (Insightful, USA). P\<0.05 was established as an a priori threshold for statistical significance.|Regression, Cox|||The primary efficacy end-point was time to reversal of cholestasis (direct bilirubin \[DB\]\<=2 mg/dL). Crude (unadjusted) hazard ratios were estimated using proportional hazard regression. Subjects who died, were transplanted, or still on PN at the end of follow-up were censored (Ref: PMID 19661785).||37.3|2.0|=0.001
71143727|NCT00910104|141781471|SUPERIORITY||Hazard Ratio (HR)|17.4||||0.001|TWO_SIDED|95.0|3.7|83.0||All P-values were 2-sided. Analyses were performed in SAS 9.1 (SAS Institute, USA) and S-plus 8 (Insightful, USA). P\<0.05 was established as an a priori threshold for statistical significance.|Regression, Cox|||The primary efficacy end-point was time to reversal of cholestasis (direct bilirubin \[DB\]\<=2 mg/dL). Adjusted hazard ratios were estimated using proportional hazard regression adjusted for baseline covariates (including duration of parenteral nutrition (PN) and baseline DB). Subjects who died, were transplanted, or still on PN at the end of follow-up were censored (Ref: PMID 19661785).||83|3.7|0.001
71143728|NCT00910104|141781471|OTHER||||||<|0.0001|||||||Fisher Exact|||Comparison of proportion with reversal of cholestasis (direct bilirubin \<=2.0 mg/dL).||||<0.0001
71143729|NCT04739982|141781500|SUPERIORITY||Cohen's D|0.03|STANDARD_ERROR_OF_MEAN|1.36||0.41|TWO_SIDED|95.0|-0.21|0.27||An independent samples t-test was conducted to compare the change in baseline and follow-up scores of treatment and treatment as usual participants.|t-test, 1 sided|Degrees of freedom=274 Significance level=.05||||.27|-.21|.41
71143730|NCT04739982|141781501|SUPERIORITY||Cohen's D|0.153|STANDARD_ERROR_OF_MEAN|1.45||0.095|TWO_SIDED|95.0|-0.08|0.39|||t-test, 1 sided|||||.39|-.08|.095
71143731|NCT04739982|141781503|SUPERIORITY||Cohen's D|0.19|STANDARD_ERROR_OF_MEAN|0.55||0.09|TWO_SIDED|95.0|-0.09|0.47|||t-test, 1 sided|||||.47|-.09|.09
71143732|NCT02913482|141781560|SUPERIORITY|Result compared to a performance criterion of 5% derived from natural history data.|||||<|0.0001|||||||One-sided Exact Binomial Test|||||||<0.0001
71143733|NCT02913482|141781561|SUPERIORITY|Result compared to a performance criterion of 17% derived from natural history data.|||||<|0.0001|||||||One-sided Exact Binomial Test|||||||<0.0001
71143734|NCT02913482|141781562|SUPERIORITY|Result compared to a performance criterion of 17% derived from natural history data. Statistical analysis was only performed for Month 12 data.|||||<|0.0001|||||||One-sided Exact Binomial Test|||||||<0.0001
71143735|NCT02913482|141781568|SUPERIORITY|Result compared to a performance criterion of 12% derived from natural history data. Statistical analysis was only performed for Month 12 data.|||||<|0.0001|||||||One-sided Exact Binomial Test|||||||<0.0001
71143736|NCT02913482|141781570|SUPERIORITY|Result compared to a performance criterion of 5% derived from natural history data.|||||<|0.0001|||||||One-sided Exact Binomial Test|||||||<0.0001
71143737|NCT02913482|141781571|SUPERIORITY|Result compared to a performance criterion of 5% derived from natural history data.|||||<|0.0001|||||||One-sided Exact Binomial Test|||||||<0.0001
71143738|NCT02913482|141781572|SUPERIORITY|Result compared to a performance criterion of 5% derived from natural history data.||||||1|||||||One-sided Exact Binomial Test|||||||1.0000
71143739|NCT02913482|141781573|SUPERIORITY|Result compared to a performance criterion of 5% derived from natural history data.||||||1|||||||One-sided Exact Binomial Test|||||||1.0000
71143740|NCT02913482|141781577|SUPERIORITY|Result compared to a performance criterion of 42% derived from natural history data. Statistical analysis was only performed for Month 12 data.|||||<|0.0001|||||||One-sided Z-test|||||||<0.0001
71143741|NCT02913482|141781578|SUPERIORITY|Result compared to a performance criterion of 60% derived from natural history data. Statistical analysis was only performed for Month 12 data.||||||0.0005|||||||One-sided Z-test|||||||0.0005
71143742|NCT02913482|141781579|SUPERIORITY|Result compared to a performance criterion of 89% derived from natural history data. Statistical analysis was only performed for Month 12 data.||||||0.2595|||||||One-sided Z-test|||||||0.2595
71143743|NCT01983228|141781592|SUPERIORITY||Odds Ratio (OR)|1.61||||0.09|TWO_SIDED|95.0|0.94|2.77||Multiple logistic regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Logistic|||measured change as a responder yes/no (30% or greater improvement from baseline).||2.77|0.94|0.09
71143744|NCT01983228|141781593|SUPERIORITY||Median Difference (Final Values)|-0.2||||0.34|TWO_SIDED|95.0|-0.62|0.21||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.21|-0.62|0.34
71143745|NCT01983228|141781594|SUPERIORITY||Mean Difference (Final Values)|-0.52||||0.38|TWO_SIDED|95.0|-1.69|0.65||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.65|-1.69|0.38
71143746|NCT01983228|141781595|SUPERIORITY||Mean Difference (Final Values)|-0.59||||0.28|TWO_SIDED|95.0|-1.68|0.49||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.49|-1.68|0.28
71143747|NCT01983228|141781596|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.05|TWO_SIDED|95.0|0.0|0.77||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.77|-0.00|0.05
71143748|NCT01983228|141781597|SUPERIORITY|Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Mean Difference (Final Values)|193.9||||0.56|TWO_SIDED|95.0|-454.93|842.73||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||842.73|-454.93|0.56
71143749|NCT01983228|141781598|SUPERIORITY||Odds Ratio (OR)|1.49||||0.16|TWO_SIDED|95.0|0.85|2.62||Multiple logistic regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Logistic|||measured change as a responder yes/no (30% or greater improvement from baseline).||2.62|0.85|0.16
71143750|NCT01983228|141781599|SUPERIORITY||Mean Difference (Final Values)|-0.61||||0.002|TWO_SIDED|95.0|-0.99|-0.23||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||-0.23|-0.99|0.002
71143751|NCT01983228|141781600|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.54|TWO_SIDED|95.0|-0.79|1.51||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||1.51|-0.79|0.54
71143752|NCT01983228|141781601|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.41|TWO_SIDED|95.0|-0.66|1.62||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||1.62|-0.66|0.41
71143753|NCT01983228|141781602|SUPERIORITY||Mean Difference (Final Values)|-0.72|||<|0.0001|TWO_SIDED|95.0|-1.07|-0.38||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||-0.38|-1.07|<0.0001
71143754|NCT01983228|141781603|SUPERIORITY||Mean Difference (Final Values)|540.78||||0.06|TWO_SIDED|95.0|-28.77|1110.33||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||1110.33|-28.77|0.06
71143755|NCT01983228|141781604|SUPERIORITY||Mean Difference (Final Values)|2.93||||0.05|TWO_SIDED|95.0|-0.01|5.86||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||5.86|-0.01|0.05
71143756|NCT01983228|141781605|SUPERIORITY||Mean Difference (Final Values)|0.76||||0.01|TWO_SIDED|95.0|0.15|1.36||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||1.36|0.15|0.01
71143757|NCT01983228|141781606|SUPERIORITY||Mean Difference (Final Values)|-1.07||||0.15|TWO_SIDED|95.0|-2.53|0.39||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.39|-2.53|0.15
70868976|NCT01153347|141223801|SUPERIORITY_OR_OTHER||LS mean|0.5|STANDARD_ERROR_OF_MEAN|1.58||0.745|TWO_SIDED|95.0|-2.59|3.62|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SIS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||3.62|-2.59|0.745
70951786|NCT05262751|141404372|OTHER||gMean Ratio|23.94|||||TWO_SIDED|90.0|13.51|42.42|||||gMean Ratio: MR1-2/R. Intra-individual Geometric coefficient of variation \[%\] = 58.8|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||42.42|13.51|
70951787|NCT05262751|141404372|OTHER||gMean Ratio|68.55|||||TWO_SIDED|90.0|50.07|93.86|||||gMean ratio: MR2-1/R. Intra-individual Geometric coefficient of variation \[%\] = 50.0|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||93.86|50.07|
70951788|NCT05262751|141404372|OTHER||gMean Ratio|66.85|||||TWO_SIDED|90.0|48.77|91.64|||||gMean ratio: MR2-2/R. Intra-individual Geometric coefficient of variation \[%\] = 50.0|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||91.64|48.77|
70951789|NCT05262751|141404373|OTHER||gMean Ratio|11.96|||||TWO_SIDED|90.0|8.88|16.11|||||gMean ratio: MR1-1/R. Intra-individual Geometric coefficient of variation \[%\] = 23.5|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||16.11|8.88|
70951790|NCT05262751|141404373|OTHER||gMean Ratio|13.98|||||TWO_SIDED|90.0|10.59|18.46|||||gMean ratio: MR1-2/R. Intra-individual Geometric coefficient of variation \[%\] = 23.5|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||18.46|10.59|
70951791|NCT05262751|141404373|OTHER||gMean Ratio|32.13|||||TWO_SIDED|90.0|26.46|39.01|||||gMean ratio: MR2-1/R. Intra-individual Geometric coefficient of variation \[%\] = 29.3.|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||39.01|26.46|
71143758|NCT01983228|141781607|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.56|TWO_SIDED|95.0|-0.8|1.47||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||1.47|-0.80|0.56
71143759|NCT01983228|141781608|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.38|TWO_SIDED|95.0|-0.17|0.46||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.46|-0.17|0.38
70951792|NCT05262751|141404373|OTHER||gMean Ratio|31.38|||||TWO_SIDED|90.0|25.71|38.3|||||gMean ratio: MR2-2/R. Intra-individual Geometric coefficient of variation \[%\] = 29.3.|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||38.30|25.71|
70951793|NCT03519204|141404374|SUPERIORITY||Responder Rate Difference|84.7|||<|0.0001|TWO_SIDED|95.0|68.2|94.2||P-value was based on 2-sided Fisher's exact test comparing responder rate between treatment group and no-treated control group.|Fisher Exact|||||94.2|68.2|<0.0001
70951794|NCT03519204|141404376|SUPERIORITY||Median Difference|0.558|STANDARD_ERROR_OF_MEAN|0.109492|<|0.0001|TWO_SIDED|95.0|0.3447|0.7739||P-value was computed using Wilcoxon test with normal approximation.|Wilcoxon Rank-sum Test||The median difference (the location shift) and its 95% CI were computed using Hodges-Lehmann estimation associated with Wilcoxon statistics.|||0.77390|0.34470|<0.0001
70951795|NCT03519204|141404377|SUPERIORITY||Median Difference|13.04|STANDARD_ERROR_OF_MEAN|2.122|<|0.0001|TWO_SIDED|95.0|8.861|17.18||P-value was computed using Wilcoxon test with normal approximation.|Wilcoxon Rank-sum Test||The median difference (the location shift) and its 95% CI were computed using Hodges-Lehmann estimation associated with Wilcoxon statistics.|||17.180|8.861|<0.0001
70951796|NCT02627118|141404381|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
71143760|NCT01983228|141781609|SUPERIORITY||Odds Ratio (OR)|1.2||||0.56|TWO_SIDED|95.0|0.66|2.19||Logistic regression modeling the odds of yes to using opioids for pain treatment adjusting for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Logistic|||||2.19|0.66|0.56
71143761|NCT01983228|141781610|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.21|TWO_SIDED|95.0|-0.18|0.84||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.84|-0.18|0.21
70951797|NCT01572740|141404382|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-1.3|||<|0.0001||95.0|-1.47|-1.13|||ANCOVA|||||-1.13|-1.47|<0.0001
70951798|NCT01572740|141404383|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.81|||<|0.0001||95.0|-0.99|-0.63|||ANCOVA|||||-0.63|-0.99|<0.0001
70951799|NCT01572740|141404384|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.83|||<|0.0006||95.0|-1.3|-0.36|||ANCOVA|||||-0.36|-1.30|<0.0006
70951800|NCT01572740|141404385|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.26||||0.2511||95.0|-0.7|0.18|||ANCOVA|||||0.18|-0.70|0.2511
70951801|NCT01572740|141404386|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-1.87|||<|0.0001||95.0|-2.37|-1.38|||ANCOVA|||||-1.38|-2.37|<0.0001
70951802|NCT01572740|141404387|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-1.28|||<|0.0001||95.0|-1.73|-0.83|||ANCOVA|||||-0.83|-1.73|<0.0001
70951803|NCT01572740|141404388|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.73||||0.0023||95.0|-1.2|-0.26|||ANCOVA|||||-0.26|-1.20|0.0023
70951804|NCT01572740|141404389|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.39||||0.1787||95.0|-0.97|0.18|||ANCOVA|||||0.18|-0.97|0.1787
70951805|NCT01572740|141404390|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.14||||0.4806||95.0|-0.54|0.25|||ANCOVA|||||0.25|-0.54|0.4806
71143762|NCT02005016|141781614|OTHER|This was a single-group study. A t-test was administered comparing pre- and post-treatment PNT scores (range: 1-175; higher scores are better).|||||<|0.005|||||||t-test, 1 sided|||||||<0.005
70951806|NCT01572740|141404391|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.35||||0.2074||95.0|-0.91|0.2|||ANCOVA|||||0.20|-0.91|0.2074
70951807|NCT00137969|141404396|SUPERIORITY_OR_OTHER|||||||0.4875||||||One-sided p-value.|Wilcoxon (Mann-Whitney)|||Stratified by randomization factors (race and initial prednisone dose)||||0.4875
71143763|NCT02005016|141781615|OTHER|This was a single-group study. A t-test was administered comparing pre- and post-treatment CAT modality mean T-scores (range: 30-70, mean: 50; higher scores are better).|||||<|0.001|||||||t-test, 1 sided|||||||<0.001
70951808|NCT00137969|141404397|SUPERIORITY_OR_OTHER|||||||0.823|||||||Wilcoxon (Mann-Whitney)|||Stratified by randomization factors (race and initial prednisone dose)||||0.8230
70951809|NCT00137969|141404398|SUPERIORITY_OR_OTHER|||||||0.4318|||||||Cochran-Mantel-Haenszel|||Stratified by randomization factors (race and initial prednisone dose)||||0.4318
70951810|NCT00137969|141404399|SUPERIORITY_OR_OTHER|||||||0.9069|||||||Cochran-Mantel-Haenszel|||Stratified by randomization factors (race and initial prednisone dose)||||0.9069
70951811|NCT00137969|141404400|SUPERIORITY_OR_OTHER|||||||0.5602|||||||Cochran-Mantel-Haenszel|||Stratified by randomization factors (race and initial prednisone dose)||||0.5602
70951812|NCT00137969|141404401|SUPERIORITY_OR_OTHER|||||||0.8979|||||||Log Rank|||Stratified by randomization factors (race and initial prednisone dose)||||0.8979
70951813|NCT00137969|141404402|SUPERIORITY_OR_OTHER|||||||0.1277|||||||ANCOVA|||Stratified by randomization factors (race and initial prednisone dose)||||0.1277
70951814|NCT00137969|141404403|SUPERIORITY_OR_OTHER|||||||0.6202|||||||Cochran-Mantel-Haenszel|||Stratified by randomization factors (race and initial prednisone dose)||||0.6202
70951815|NCT02269423|141404419|OTHER||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||<0.001
70951816|NCT02269423|141404419|OTHER||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||<0.001
70951817|NCT02269423|141404419|OTHER||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||<0.001
70951818|NCT02269423|141404419|OTHER|||||||0.161||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||0.161
70951819|NCT02269423|141404419|OTHER|||||||0.008||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||0.008
70951820|NCT02269423|141404419|OTHER|||||||0.173||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||0.173
70951821|NCT02269423|141404420|OTHER||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||<0.001
70951822|NCT02269423|141404420|OTHER||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||<0.001
70951823|NCT02269423|141404420|OTHER||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||<0.001
70951824|NCT02269423|141404420|OTHER|||||||0.102||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||0.102
71143764|NCT01323582|141781633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.6|STANDARD_ERROR_OF_MEAN|11.7||0.76|TWO_SIDED|95.0|-21.5|28.6|||t-test, 2 sided|Satterthwaite corrected t-test was used|A positive (negative) value would suggest AZI values would tend to be larger (smaller) than EZ values.|Study planned to accrue 50 subjects, but due to difficult recruitment was not able to meet its objective.||28.6|-21.5|0.76
71143765|NCT01323582|141781634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|2.8||0.65||95.0|-4.8|7.5|||t-test, 2 sided|Satterthwaite Correction used|A positive (negative) value would suggest AZI values would tend to be larger (smaller) than EZ values.|Study planned to accrue 50 subjects, but due to difficult recruitment was not able to meet its objective.||7.5|-4.8|0.65
71143766|NCT01323582|141781635|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|2.3||0.88|TWO_SIDED|95.0|-4.58|5.19|||t-test, 2 sided|Satterthwaite correction for unequal standard deviations was used|A positive (negative) value would suggest AZI values would tend to be larger (smaller) than EZ values.|Half of the period 2 minus period 1 differences were used, since the difference between these two derived means is an unbiased estimate of the effect size.||5.19|-4.58|0.88
71143767|NCT01323582|141781636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.49|STANDARD_ERROR_OF_MEAN|5.7||0.8|TWO_SIDED|95.0|-13.9|10.9|||t-test, 2 sided|Satterthwaite Corrected t-test|A positive (negative) value would suggest AZI values would tend to be larger (smaller) than EZ values.|||10.9|-13.9|0.80
71143768|NCT01323582|141781637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.8|STANDARD_ERROR_OF_MEAN|9.1||0.21|TWO_SIDED|95.0|-30.9|7.3|||t-test, 2 sided||Negative values suggest shorter emptying time post-treatment.|||7.3|-30.9|0.21
71143769|NCT01323582|141781638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.0|STANDARD_ERROR_OF_MEAN|6.61||0.034|TWO_SIDED|95.0|-28.7|-1.26|||t-test, 2 sided||Negative values suggest shorter emptying time post-treatment.|||-1.26|-28.7|0.034
71143770|NCT01323582|141781639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.32|STANDARD_ERROR_OF_MEAN|1.98||0.015|TWO_SIDED|95.0|-9.48|-1.16|||t-test, 2 sided||Lower scores are favorable.|||-1.16|-9.48|0.015
71143771|NCT01323582|141781640|SUPERIORITY_OR_OTHER||Median Difference (Net)|-6.4|STANDARD_ERROR_OF_MEAN|2.2||0.0083|TWO_SIDED|95.0|-10.97|-1.83|||t-test, 2 sided||Lower scores are favorable.|||-1.83|-10.97|0.0083
71143772|NCT00083889|141781641|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5268|||<|0.0001|TWO_SIDED|95.0|0.4316|0.643||p-value from 2-sided, unstratified test.|Log Rank||Assuming proportional hazards, a hazard ratio les than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in favor of IFN-a.|Unstratified analysis: Hazard Ratio (SU011248 vs IFN-α). Progression-free survival (PFS) was assessed in each treatment arm using the Kaplan-Meier method.||0.6430|0.4316|<0.0001
71143773|NCT00083889|141781641|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5136|||<|1e-05|TWO_SIDED|95.0|0.4196|0.6288||p-value is from 2-sided, stratified test. Stratification factors were: Lactic Dehydrogenase (LDH) \> or \<= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248: a hazard ratio greater than 1 indicates a reduction in favor of IFN-a.|Stratified analysis: Hazard Ratio (SU011248 vs IFN-a).||0.6288|0.4196|<.00001
71143774|NCT00083889|141781642|SUPERIORITY_OR_OTHER||treatment difference|30.93|||<|0.001|TWO_SIDED|95.0|25.31|36.56|||Chi-squared||95% confidence interval was calculated based on a normal distribution.|||36.56|25.31|<0.001
71143775|NCT00083889|141781643|SUPERIORITY_OR_OTHER||treatment difference|33.66|||<|0.001|TWO_SIDED|95.0|27.62|39.69|||Chi-squared||95% confidence interval was calculated based on a normal distribution.|||39.69|27.62|<0.001
71143776|NCT00083889|141781644|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8209||||0.051|TWO_SIDED|95.0|0.673|1.0013||p-value is from 2-sided, unstratified tests.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a|Unstratified analysis: Hazard Ratio (SU011248 vs IFN-α).||1.0013|0.6730|0.0510
71143777|NCT00083889|141781644|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8209||||0.0128|TWO_SIDED|95.0|0.673|1.0013||p-value is from 2-sided, unstratified tests.|Wilcoxon (Mann-Whitney)||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a.|Unstratified analysis: Hazard Ratio (SU011248 vs IFN-α).||1.0013|0.6730|0.0128
71143778|NCT00083889|141781644|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8179||||0.049|TWO_SIDED|95.0|0.6692|0.9995||p-value is from 2-sided, stratified tests. Stratification factors were: Lactic Dehydrogenase (LDH) \> or \<= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a.|Stratified analysis: Hazard Ratio (SU011248 vs IFN-α).||0.9995|0.6692|0.0490
71143779|NCT00083889|141781645|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5332|||<|0.0001|TWO_SIDED|95.0|0.4345|0.6544||p-value is from 2-sided, unstratified test.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a|Unstratified Analysis: Hazard Ratio (SU011248 vs IFN-a)||0.6544|0.4345|<0.0001
71143780|NCT00083889|141781645|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.516|||<|1e-05|TWO_SIDED|95.0|0.4191|0.6352||p-value is from 2-sided, stratified test. Stratification factors are: Lactic Dehydrogenase (LDH) \> or \<= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a.|Stratified Analysis: Hazard Ratio (SU011248 vs IFN-a)||0.6352|0.4191|<.00001
71143781|NCT00083889|141781646|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5454|||<|0.0001|TWO_SIDED|95.0|0.4558|0.6526||p-value is from 2-sided, unstratified test.|Log Rank||Assuming proportional hazards, a hazard ratio \< 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio \> 1 indicates a reduction in hazard rate in favor of IFN-a.|Unstratified Analysis: Hazard Ratio (SU011248 vs IFN-α)||0.6526|0.4558|<0.0001
70868977|NCT01751178|141223810|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.061|||<|0.0001|TWO_SIDED|95.0|-0.081|-0.041||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline GSI as a covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis stated that there was no difference between the two groups.||-0.041|-0.081|<0.0001
70951825|NCT02269423|141404420|OTHER|||||||0.124||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||0.124
70951826|NCT02269423|141404420|OTHER|||||||0.918||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||0.918
70951827|NCT01006980|141404454|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.26|0.55|||Log Rank||The hazard ratio for death for vemurafenib relative to dacarbazine and the associated 95% confidence interval were computed using an unstratified Cox regression model.|The trial had a power of 80% to detect a hazard ratio of 0.65 for overall survival with an alpha level of 0.045 (an increase in median survival from 8 months for dacarbazine to 12.3 months for vemurafenib), one interim analysis for overall survival at 50% information.||0.55|0.26|<0.0001
70951828|NCT01006980|141404455|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26|||<|0.0001|TWO_SIDED|95.0|0.2|0.33|||Log Rank||Hazard ratios for treatment with vemurafenib, as compared with dacarbazine, were estimated with the use of unstratified Cox regression.|The trial had a power of 90% to detect a hazard ratio of 0.55 for progression-free survival with an alpha level of 0.005 (an increase in median survival from 2.5 months for dacarbazine to 4.5 months for vemurafenib).||0.33|0.20|<.0001
70951829|NCT01182441|141404501|SUPERIORITY|Success for this endpoint was achieved if the probability of experiencing an event was statistically less than the performance goal, defined as 2.67%, with an upper bound of the one-sided 95% credible interval less than the performance goal.|probability of experiencing an event|2.2|||||ONE_SIDED|95.0||2.652||||||Bayesian calculations were used to incorporate the data from PROTECT AF CAP Registry through a conjugate beta-binomial model. A one-sided upper 95% credible interval for the event rate was calculated based off this posterior distribution.||2.652||
70951830|NCT01182441|141404502|NON_INFERIORITY|This endpoint is met if the 95% Credible Interval for the rate ratio of WATCHMAN versus Warfarin is entirely less than 1.75.|Risk Ratio (RR)|1.07|||||TWO_SIDED|95.0|0.57|1.89||||||A Bayesian piecewise exponential model was used to model the 18-month event rates. Historical priors for each interval model were based on PROTECT AF. Hazards were modeled for 0-7 day, 7-60 day, 60-182 day, and 182+ day intervals. Event rates were estimated separately by treatment group and event type. The posterior distribution for the 18-month event rate ratio (WATCHMAN vs. Warfarin), and the corresponding equitailed 95% credible interval, were determined via Monte Carlo simulations.||1.89|0.57|
70951831|NCT01182441|141404503|NON_INFERIORITY|This endpoint is met if either the 95% Credible Interval for the risk ratio \< 2.0 or the 95% Credible Interval for the risk difference is \< 0.0275.|Risk Difference (RD)|0.0053|||||TWO_SIDED|95.0|-0.019|0.0273||||||A Bayesian piecewise exponential model was used to model the 18-month event rates. Historical priors for each interval were based on PROTECT AF. Hazards were modeled for 0-7 day, 7-60 day, 60-182 day, and 182+ day intervals. Event rates were estimated separately for the WATCHMAN and Warfarin groups. The posterior distribution for the 18-month event rate ratio (WATCHMAN vs. Warfarin), and the corresponding equitailed 95% credible interval, were determined via Monte Carlo simulations.||0.0273|-0.0190|
70951832|NCT01182441|141404503|NON_INFERIORITY|This endpoint is met if either the 95% Credible Interval for the risk ratio \< 2.0 or the 95% Credible Interval for the risk difference is \< 0.0275.|Risk Ratio (RR)|1.6|||||TWO_SIDED|95.0|0.5|4.2||||||A Bayesian piecewise exponential model was used to model the 18-month event rates. Historical priors for each interval were based on PROTECT AF. Hazards were modeled for 0-7 day, 7-60 day, 60-182 day, and 182+ day intervals. Event rates were estimated separately for the WATCHMAN and Warfarin groups. The posterior distribution for the 18-month event rate ratio (WATCHMAN vs. Warfarin), and the corresponding equitailed 95% credible interval, were determined via Monte Carlo simulations.||4.2|0.5|
70951833|NCT05504954|141404522|SUPERIORITY||Odds Ratio (OR)|0.26||||0.15|TWO_SIDED|95.0|0.04|1.59|||Regression, Logistic|||||1.59|0.04|0.15
70951834|NCT05504954|141404524|SUPERIORITY||Odds Ratio (OR)|2.83||||0.1|TWO_SIDED|95.0|0.81|9.89|||Regression, Logistic|||||9.89|0.81|0.10
70951835|NCT05504954|141404525|SUPERIORITY||beta coefficient|5.0||||0.65|TWO_SIDED|95.0|-17.78|27.78|||Regression, Linear|||||27.78|-17.78|0.65
70951836|NCT05504954|141404526|SUPERIORITY|||||||0.7|||||||Fisher Exact|||||||0.70
70951837|NCT05504954|141404527|SUPERIORITY|||||||0.7|||||||Fisher Exact|||||||.70
70951838|NCT05504954|141404528|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
70951839|NCT05504954|141404529|SUPERIORITY|||||||0.64|||||||Fisher Exact|||||||0.64
70951840|NCT00659880|141404550|SUPERIORITY_OR_OTHER|||||||0.06|||||||Friedman|||||||0.06
70951841|NCT01465763|141404572|SUPERIORITY_OR_OTHER||Percent Difference|10.3||||0.007|TWO_SIDED|95.0|4.3|16.3|||CMH Chi-square test|||P-value based on Cochran-Mantel-Haenszel (CMH) chi-square test stratified by prior treatment with anti-tumor necrosis factor (TNF), steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using Non-responder imputation (NRI).||16.3|4.3|0.0070
70951842|NCT01465763|141404573|SUPERIORITY_OR_OTHER||Percent Difference|15.7||||0.0005|TWO_SIDED|95.0|8.1|23.4|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||23.4|8.1|0.0005
70951843|NCT01465763|141404574|SUPERIORITY_OR_OTHER||Percent Difference|27.1|||<|0.0001|TWO_SIDED|95.0|17.7|36.5|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||36.5|17.7|<0.0001
70951844|NCT01465763|141404575|SUPERIORITY_OR_OTHER||Percent Difference|5.1||||0.0345|TWO_SIDED|95.0|1.9|8.3|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||8.3|1.9|0.0345
70951845|NCT01465763|141404576|SUPERIORITY_OR_OTHER||Percent Difference|10.3||||0.007|TWO_SIDED|95.0|4.3|16.3|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||16.3|4.3|0.0070
70951846|NCT01465763|141404577|SUPERIORITY_OR_OTHER||Percent Difference|6.0||||0.0601|TWO_SIDED|95.0|1.0|11.1|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||11.1|1.0|0.0601
70951847|NCT01465763|141404578|SUPERIORITY_OR_OTHER||Percent Difference|6.5||||0.0043|TWO_SIDED|95.0|4.3|8.7|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||8.7|4.3|0.0043
70951848|NCT01465763|141404580|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||Mixed-Effects Model|||At Week 2: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and participants as a random effect.||-0.5|-1.3|<0.0001
70868978|NCT01751178|141223810|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|||<|0.0001|TWO_SIDED|95.0|-0.09|-0.05||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline GSI as a covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis stated that there was no difference between the two treatment groups.||-0.050|-0.090|<0.0001
70868979|NCT01751178|141223811|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.08|||<|0.0001|TWO_SIDED|95.0|-0.1|-0.05||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline GI as a covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis that there was no difference between the two treatment groups.||-0.05|-0.10|<0.0001
70951849|NCT01465763|141404580|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.5|-0.7|||Mixed-Effects Model|||At Week 4: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and participants as a random effect.||-0.7|-1.5|<0.0001
70951850|NCT01465763|141404580|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.9|-1.1|||Mixed-Effects Model|||At Week 8: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and participants as a random effect.||-1.1|-1.9|<0.0001
70951851|NCT01465763|141404581|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.5|-1.4|||ANCOVA|||The change from Baseline at Week 8 was analyzed using an analysis of covariance (ANCOVA) model with treatment group, prior treatment with anti-TNF, steroid use at baseline and geographic region as factors and baseline as a covariate based on the observed-case data.||-1.4|-2.5|<0.0001
70951852|NCT01711853|141404600|SUPERIORITY_OR_OTHER|||||||0.5186|TWO_SIDED||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||"Patients were classified into groups for renal function based on the median values for renal function (1: ≤ median GFR (Glomerular filtration rate), 2: \> median GFR).~Median is calculated based on trial data of treated set"||||0.5186
70951853|NCT01711853|141404600|SUPERIORITY_OR_OTHER|||||||0.9883|TWO_SIDED||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||"Patients were classified into groups for renal function based on the median values for renal function (1: ≤ median age, 2: \> median age).~Median is calculated based on trial data of treated set"||||0.9883
70951854|NCT01711853|141404600|SUPERIORITY_OR_OTHER|||||||0.7853|TWO_SIDED||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||Patients were classified based on the gender distribution.||||0.7853
70951855|NCT01711853|141404601|SUPERIORITY_OR_OTHER|||||||0.4692|TWO_SIDED||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||"Patients were classified into groups for renal function based on the median values for renal function (1: ≤ median GFR, 2: \> median GFR).~Median is calculated based on trial data of treated set"||||0.4692
70951856|NCT01711853|141404601|SUPERIORITY_OR_OTHER|||||||0.9734|TWO_SIDED||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||"Patients were classified into groups for renal function based on the median values for renal function (1: ≤ median age, 2: \> median age).~Median is calculated based on trial data of treated set"||||0.9734
70951857|NCT01711853|141404601|SUPERIORITY_OR_OTHER|||||||0.9201|TWO_SIDED||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||Patients were classified based on the gender distribution.||||0.9201
70951858|NCT02992691|141404611|OTHER||Mean Difference (Net)|-0.01||||0.6674|TWO_SIDED|95.0|-0.06|0.04||From ANCOVA analysis for change from pre-brushing with treatment and period as fixed effect, participant as random effect, participant-level baseline and period level minus participant-level baseline as covariates.|ANCOVA|||This comparison was tested under a null hypothesis of no difference against alternative hypothesis of a difference between treatments||0.04|-0.06|0.6674
70951859|NCT00392925|141404667|SUPERIORITY_OR_OTHER|||||||0.0004|||||||ANCOVA|||Based on an Analysis of Covariance model including factors for treatment group, sex, enrollment body mass index (BMI) category, lead-in body weight loss category, and baseline (Day 1) weight as a covariate. The p-value is for testing the null hypothesis of no difference between treatments. Analysis performed two-sided at a 5% significance level to compare treatment groups.||||0.0004
71143782|NCT00083889|141781646|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5417|||<|1e-05|TWO_SIDED|95.0|0.4519|0.6492||p-value is from 2-sided, stratified test. Stratification factors were: Lactic Dehydrogenase (LDH) \> or \<= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a.|Stratified Analysis: Hazard Ratio (SU011248 vs IFN-α)||0.6492|0.4519|<.00001
71143783|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.913|||<|0.0001|TWO_SIDED|95.0|1.376|2.45|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) baseline score (intercept and time since randomization are included as random effects).||2.450|1.376|<.0001
70868980|NCT01751178|141223811|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.08|||<|0.0001|TWO_SIDED|95.0|-0.11|-0.06||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline GI as a covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis stated that there was no difference between the two treatment groups.||-0.06|-0.11|<0.0001
70951860|NCT01281839|141404694|SUPERIORITY_OR_OTHER||Difference in proportions of SVR12|43.8|||<|0.001|TWO_SIDED|95.0|34.6|53.0|||Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference in proportions of SVR12 between the treatment groups.||53.0|34.6|<0.001
70951861|NCT01281839|141404695|SUPERIORITY_OR_OTHER||Difference in proportions of SVR72|43.3|||<|0.001|TWO_SIDED|95.0|34.1|52.5|||Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference in proportions of SVR72 between the treatment groups.||52.5|34.1|<0.001
70951862|NCT01281839|141404696|SUPERIORITY_OR_OTHER||Difference in proportions of SVR24|44.1|||<|0.001|TWO_SIDED|95.0|34.9|53.2|||Cochran-Mantel-Haenszel|||There is no difference in proportions of SVR24 between the treatment groups.||53.2|34.9|<0.001
70951863|NCT01281839|141404697|SUPERIORITY_OR_OTHER||Difference in proportions of SVR4|41.0|||<|0.001|TWO_SIDED|95.0|32.1|49.9|||Cochran-Mantel-Haenszel|||There is no difference in proportions of SVR24 between the treatment groups.||49.9|32.1|<0.001
70951864|NCT03168542|141404752|SUPERIORITY|Superiority was concluded if the lower 95% of the confidence limit of the proportion of subjects who require no more than one modification was greater than 50%.|Proportion|0.952|||||TWO_SIDED|95.0|0.756|1.0|||Agresti-Coull confidence interval|Agresti-Coull method was used to estimate the confidence interval of the binomial proportions.||||1.000|0.756|
70951865|NCT02514551|141404763|SUPERIORITY||Hazard Ratio (HR)|0.617|||||TWO_SIDED|95.0|0.447|0.853|||||Unstratified cox proportional hazards model comparing Ramucirumab I4T-MC-JVCZ and I4T-IE-JVBE (NCT01170663)|"This analysis were comparison of PFS for participants treated with ramucirumab 12 mg/kg plus paclitaxel in Study I4T-MC-JVCZ versus placebo plus paclitaxel in I4T-IE-JVBE (NCT01170663) using meta-analysis.~Placebo + 80 mg/m² Paclitaxel in I4T-IE-JVBE Number of participants: 335, Median (95% CI), months: 2.86 (2.79 to 3.02)"||0.853|0.447|
70951866|NCT02514551|141404764|SUPERIORITY||Hazard Ratio (HR)|0.963|||||TWO_SIDED|95.0|0.727|1.274|||||Unstratified cox proportional hazards model.|||1.274|0.727|
70951867|NCT00672737|141404769|SUPERIORITY_OR_OTHER||Slope|0.0025|||<|0.05|TWO_SIDED|95.0|0.0009|0.0041|||Regression, Linear|Adjusted for body mass index, age of the volunteers, and a binary variable indicating the type (home-based vs. in-laboratory).|Mixed linear regression|Beta for IGFBP-1: for every 1-pg/mL increase in its serum level the cold pain threshold will additionally increase by 0.0025 seconds for every 1-mcg/mL increase in the plasma level of remifentanil.||0.0041|0.0009|<0.05
70951868|NCT00672737|141404769|SUPERIORITY_OR_OTHER||Slope|-0.9694||||0.05|TWO_SIDED|95.0|-1.9127|-0.0261|||Regression, Linear|Adjusted for body mass index, age of the volunteers, and a binary variable indicating the type (home-based vs. in-laboratory).|Mixed linear regression|Beta for SaO2: for every 1-%-absolute decrease in the nadir SaO2 the cold pain threshold will additionally increase by 0.9694 seconds for every 1-mcg/mL increase in the plasma level of remifentanil.||-0.0261|-1.9127|0.05
70951869|NCT00672737|141404770|SUPERIORITY_OR_OTHER||Slope|-0.0001|||<|0.05|TWO_SIDED|95.0|-0.0001|-0.0001|||Regression, Linear|Adjusted for body mass index, age of the volunteers, and a binary variable indicating the type (home-based vs. in-laboratory).|Mixed linear regression|Beta for IGFBP-1: for every 1-pg/mL increase in its serum level, the heat pain threshold will additionally decrease by 0.0001 'C for every 1-mcg/mL increase in the plasma level of remifentanil.||-0.0001|-0.0001|<0.05
71143784|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.935|||<|0.0001|TWO_SIDED|95.0|1.421|2.449|||Mixed Models Analysis|||Cycle 1 Day 28: Difference in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.449|1.421|<.0001
70951870|NCT00672737|141404770|SUPERIORITY_OR_OTHER||Slope|-0.0172|||<|0.05|TWO_SIDED|95.0|-0.018|0.0556|||Regression, Linear|Adjusted for body mass index, age of the volunteers, and a binary variable indicating the type (home-based vs. in-laboratory).|Mixed linear regression|Beta for SaO2: for every 1-%-absolute decrease in the nadir SaO2, the heat pain threshold will additionally increase by 0.0172 'C for every 1-mcg/mL increase in the plasma level of remifentanil.||0.0556|-0.018|<0.05
71143785|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.948|||<|0.0001|TWO_SIDED|95.0|1.443|2.452|||Mixed Models Analysis|||Cycle 2 Day 1: Difference in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.452|1.443|<.0001
71143786|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.97|||<|0.0001|TWO_SIDED|95.0|1.476|2.464|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.464|1.476|<.0001
71143787|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.983|||<|0.0001|TWO_SIDED|95.0|1.491|2.475|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.475|1.491|<.0001
71143788|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.005|||<|0.0001|TWO_SIDED|95.0|1.51|2.501|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.501|1.510|<.0001
71143789|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.018|||<|0.0001|TWO_SIDED|95.0|1.517|2.519|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.519|1.517|<.0001
71143790|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.04|||<|0.0001|TWO_SIDED|95.0|1.522|2.559|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.559|1.522|<.0001
70868981|NCT01751178|141223812|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-0.98|-0.62||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline Plaque as a covariate|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis stated that there was no difference between the two treatment groups in Overall Plaque scores.||-0.62|-0.98|<0.0001
70868982|NCT01751178|141223812|SUPERIORITY_OR_OTHER||Adusted Mean Difference|-0.86|||<|0.0001|TWO_SIDED|95.0|-1.04|-0.68||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline Plaque as a covariate|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis stated that there was no difference between the two treatment groups in Overall Plaque Scores.||-0.68|-1.04|<0.0001
70868983|NCT01751178|141223813|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.88|||<|0.0001|TWO_SIDED|95.0|-1.07|-0.69||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline Plaque as a covariate|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypotheses stated that there was no difference between the two treatments.||-0.69|-1.07|<0.0001
70868984|NCT01751178|141223813|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.97|||<|0.0001|TWO_SIDED|95.0|-1.16|-0.78||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline Plaque as a covariate|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypotheses stated that there was no difference between the two groups.||-0.78|-1.16|<0.0001
70868985|NCT00289991|141223814|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a true success rate of 50% in voriconazole (Vori) treatment (Tx) group and 45% in itraconazole (Itra) Tx group, sample size of 232 subjects per group=90% power to demonstrate non-inferiority of Vori to Itra using pre-specified non-inferiority margin of -10%. Sample has at least 80% power to demonstrate superiority of Vori over Itra if true success rates for Vori and Itra are 57% and 44% respectively. Based on this, up to 500 subjects were to be enrolled to obtain 464 eligible subjects.|percent difference adjusted proportions|16.4|||||TWO_SIDED|95.0|7.7|25.1|||Difference in adjusted responder rates|Difference in adjusted responder rates using Fleiss method|Overall treatment difference in adjusted proportions (expressed as percentages) calculated using Fleiss method.|"Non-inferiority inferred if lower limit of the 2-sided 95 percent (%) confidence interval (CI) for the difference between the voriconazole and itraconazole treatment groups in the adjusted proportion of subjects classified as Success at Day 180 after transplant is above -10%. Superiority achieved if 2-sided 95% CI for difference between these treatment groups in the adjusted proportion of subjects classified as Success at Day 180 after transplant does not include zero and is positive."||25.1|7.7|
70951871|NCT01460225|141404773|EQUIVALENCE|Based on the results of Camilleri et al, this should be adequate to detect up to a 30% difference in gastric emptying scan times with a p-value of 0.05 and 80% power.||||||0.003|||||||t-test, 2 sided|||Comparison of meal retention between pre-treatment and post treatment at 2 hours post meal||||0.003
70951872|NCT01460225|141404773|EQUIVALENCE|Based on the results of Camilleri et al, this should be adequate to detect up to a 30% difference in gastric emptying scan times with a p-value of 0.05 and 80% power.||||||0.122|||||||t-test, 2 sided|||Comparison of meal retention between pre-treatment and post treatment at 4 hours post meal||||0.122
70951873|NCT05472740|141404793|SUPERIORITY|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
70951874|NCT03832595|141404803|EQUIVALENCE|We determined that 1,653 patients provide 80% power to detect a hazard ratio of 0.64, or a 5% absolute risk reduction in intervention arm, assuming a primary end-point rate of 15% in the usual care group at 24 months, 20% loss to follow-up, α = 0.05, and within-practice intra-class correlation of 0.01|Hazard Ratio (HR)|0.96||||0.82|TWO_SIDED|95.0|0.67|1.38|||Mixed Models Analysis|||||1.38|0.67|0.82
70951875|NCT03832595|141404804|EQUIVALENCE|α = 0.05|Slope difference|0.011|||||TWO_SIDED|95.0|-0.008|0.029||||||||0.029|-0.008|
70951876|NCT03832595|141404805|EQUIVALENCE|α = 0.05|Rate ratio|1.21|||||TWO_SIDED|95.0|1.02|1.43||||||||1.43|1.02|
70951877|NCT03832595|141404806|EQUIVALENCE|α = 0.05|Rate ratio|0.8|||||TWO_SIDED|95.0|0.51|1.25||||||||1.25|0.51|
70951878|NCT03832595|141404807|EQUIVALENCE|α = 0.05|Rate ratio|1.18|||||TWO_SIDED|95.0|0.03|53.78||||||||53.78|0.03|
70951879|NCT03832595|141404808|EQUIVALENCE|α = 0.05|Rate ratio|1.12|||||TWO_SIDED|95.0|0.12|9.96||||||||9.96|0.12|
71143791|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.053|||<|0.0001|TWO_SIDED|95.0|1.522|2.584|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.584|1.522|<.0001
71143792|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.075|||<|0.0001|TWO_SIDED|95.0|1.515|2.635|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.635|1.515|<.0001
71143793|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.088|||<|0.0001|TWO_SIDED|95.0|1.509|2.667|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.667|1.509|<.0001
71143794|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.11|||<|0.0001|TWO_SIDED|95.0|1.494|2.727|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.727|1.494|<.0001
71143795|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.123|||<|0.0001|TWO_SIDED|95.0|1.483|2.763|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.763|1.483|<.0001
71143796|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.146|||<|0.0001|TWO_SIDED|95.0|1.461|2.83|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.830|1.461|<.0001
71143797|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.158|||<|0.0001|TWO_SIDED|95.0|1.447|2.869|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.869|1.447|<.0001
71143798|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.181|||<|0.0001|TWO_SIDED|95.0|1.42|2.941|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.941|1.420|<.0001
71143799|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.193|||<|0.0001|TWO_SIDED|95.0|1.404|2.983|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.983|1.404|<.0001
71143800|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.216|||<|0.0001|TWO_SIDED|95.0|1.373|3.059|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.059|1.373|<.0001
71143801|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.228|||<|0.0001|TWO_SIDED|95.0|1.355|3.102|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.102|1.355|<.0001
71143802|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.251|||<|0.0001|TWO_SIDED|95.0|1.321|3.18|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.180|1.321|<.0001
71143803|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.263|||<|0.0001|TWO_SIDED|95.0|1.302|3.225|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.225|1.302|<.0001
70868986|NCT00289991|141223815|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority inferred if lower limit of the 2-sided 95% confidence interval (CI) for the difference between the voriconazole and itraconazole treatment groups in the adjusted proportion of subjects classified as Success at Day 100 after transplant is above -10%. Superiority achieved if 2-sided 95% CI for difference between these treatment groups in the adjusted proportion of subjects classified as Success at Day 100 after transplant does not include zero and is positive."|percent difference adjusted proportions|15.4|||||TWO_SIDED|95.0|6.6|24.2|||Difference in adjusted responder rates|Difference in adjusted responder rates using the Fleiss method.|Overall treatment difference in adjusted proportions (expressed as percentages) calculated using Fleiss method.|||24.2|6.6|
70868987|NCT00289991|141223817|SUPERIORITY_OR_OTHER||difference in proportions: percent|-0.4||||0.7114|TWO_SIDED|95.0|-2.2|1.5|||Difference in proportions|Difference in proportions (approximate result)|Approximate 2-sided 95 percent (%) confidence interval for the difference in proportions.|Day 100; difference in proportions (expressed as percentages), voriconazole relative to itraconazole.||1.5|-2.2|0.7114
70868988|NCT00289991|141223817|SUPERIORITY_OR_OTHER||difference in proportion: percent|-0.3||||0.7759|TWO_SIDED|95.0|-2.5|1.9|||Difference in proportions|Difference in proportions (approximate result).|Approximate 2-sided 95 percent (%) confidence interval for the difference in proportions.|Day 180; difference in proportions (expressed as percentages), voriconazole relative to itraconazole.||1.9|-2.5|0.7759
70868989|NCT00289991|141223818|SUPERIORITY_OR_OTHER||difference in proportions: percent|0.3|||||TWO_SIDED|95.0|-6.3|6.9|||Difference in proportions|Difference in proportions (approximate result)|Approximate 2-sided 95% confidence interval for the difference in proportions.|Day 180; difference in proportions (expressed as a percentage), voriconazole relative to itraconazole.||6.9|-6.3|
70868990|NCT00289991|141223819|SUPERIORITY_OR_OTHER|||||||0.0026||95.0|||||Wilcoxon (Mann-Whitney)|2-sided Wilcoxon (Mann-Whitney)||Mann-Whitney test used to investigate the null hypothesis that the times to discontinuation of study medication in each treatment group come from the same distribution.||||0.0026
71143804|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.286|||<|0.0001|TWO_SIDED|95.0|1.266|3.305|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.305|1.266|<.0001
70868991|NCT00289991|141223820|SUPERIORITY_OR_OTHER||difference in proportions: percent|-4.8||||0.2487|TWO_SIDED|95.0|-13.0|3.4|||Difference in proportions|Difference in proportions (approximate result)|Approximate 2-sided 95 percent % confidence interval for the difference in proportions.|Day 365; difference in proportions (expressed as a percentage), voriconazole relative to itraconazole.||3.4|-13.0|0.2487
71143805|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.298|||<|0.0001|TWO_SIDED|95.0|1.246|3.351|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.351|1.246|<.0001
70868992|NCT00289991|141223822|SUPERIORITY_OR_OTHER||difference in proportions: percent|-8.8||||0.057|TWO_SIDED|95.0|-17.8|0.3|||Difference in proportions|Difference in proportions (approximate result)|Approximate 2-sided 95% confidence interval for the difference in proportions.|Difference in proportions (expressed as a percentage), voriconazole relative to itraconazole.||0.3|-17.8|0.0570
70951880|NCT03238963|141404855|OTHER||Risk Difference (RD)|0.057|STANDARD_ERROR_OF_MEAN|0.039|||TWO_SIDED|95.0|-0.053|0.192|||Chan and Zhang method|95% confidence interval was calculating using the Chan and Zhang method.|Risk difference of BI 1467335 10 milligram (mg) group minus Placebo group.|||0.192|-0.053|
70868993|NCT01606007|141223830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.1112|<|0.0001|TWO_SIDED|95.0|-0.81|-0.37||Primary endpoint was tested at alpha=0.05; significance was claimed only if Saxagliptin+Dapagliflozin+Metformin was superior to both Saxagliptin+Metformin and Dapagliflozin+Metformin.|Mixed Models Analysis|||||-0.37|-0.81|<0.0001
70868994|NCT01606007|141223830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.1108||0.0166|TWO_SIDED|95.0|-0.48|-0.05||Primary endpoint was tested at alpha=0.05; significance was claimed only if Saxagliptin+Dapagliflozin+Metformin was superior to both Saxagliptin+Metformin and Dapagliflozin+Metformin.|Mixed Models Analysis|||||-0.05|-0.48|0.0166
70951881|NCT01424813|141404860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.128|<|0.0001|TWO_SIDED|95.0|0.57|1.08||Significance at the 0.05 level.|mixed-model repeated-measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.08|0.57|<0.0001
71143806|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.321|||<|0.0001|TWO_SIDED|95.0|1.209|3.433|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.433|1.209|<.0001
71143807|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.333|||<|0.0001|TWO_SIDED|95.0|1.188|3.479|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.479|1.188|<.0001
71143808|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.356||||0.0001|TWO_SIDED|95.0|1.15|3.562|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.562|1.150|0.0001
70951882|NCT01424813|141404861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07|STANDARD_ERROR_OF_MEAN|0.198|<|0.0001|TWO_SIDED|95.0|0.68|1.46||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially \[day 1, then day 8, then day 85\] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.46|0.68|<0.0001
71143809|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.369||||0.0002|TWO_SIDED|95.0|1.128|3.609|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.609|1.128|0.0002
71143810|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.391||||0.0003|TWO_SIDED|95.0|1.089|3.693|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.693|1.089|0.0003
71143811|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.404||||0.0004|TWO_SIDED|95.0|1.067|3.74|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.740|1.067|0.0004
71143812|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.426||||0.0007|TWO_SIDED|95.0|1.027|3.825|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.825|1.027|0.0007
70951883|NCT01424813|141404876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73|STANDARD_ERROR_OF_MEAN|0.164|<|0.0001|TWO_SIDED|95.0|0.41|1.06||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially \[day 1, then day 8, then day 85\] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.06|0.41|<0.0001
70951884|NCT01424813|141404877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|0.154|<|0.0001|TWO_SIDED|95.0|0.38|0.99||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially \[day 1, then day 8, then day 85\] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||0.99|0.38|<0.0001
70951885|NCT02614183|141404882|SUPERIORITY||Mean Difference (Final Values)|-1.92|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.48|-1.37|||Mixed Models Analysis|||||-1.37|-2.48|<.001
70951886|NCT02614183|141404882|SUPERIORITY||Mean Difference (Final Values)|-1.76|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.31|-1.2|||Mixed Models Analysis|||||-1.20|-2.31|<.001
70951887|NCT02614183|141404883|SUPERIORITY||Odds Ratio (OR)|2.63|||||TWO_SIDED|95.0|2.05|3.37||||||Reduction from Baseline ≥50%||3.37|2.05|
70951888|NCT02614183|141404883|SUPERIORITY||Odds Ratio (OR)|2.48|||||TWO_SIDED|95.0|1.94|3.18||||||Reduction from Baseline ≥50%||3.18|1.94|
70951889|NCT02614183|141404883|SUPERIORITY||Odds Ratio (OR)|2.65|||||TWO_SIDED|95.0|2.04|3.45||||||Reduction from Baseline ≥75%||3.45|2.04|
70951890|NCT02614183|141404883|SUPERIORITY||Odds Ratio (OR)|2.62|||||TWO_SIDED|95.0|2.01|3.41||||||Reduction from Baseline ≥75%||3.41|2.01|
70951891|NCT02614183|141404883|SUPERIORITY||Odds Ratio (OR)|2.8|||||TWO_SIDED|95.0|1.96|4.01||||||Reduction from Baseline = 100%||4.01|1.96|
70951892|NCT02614183|141404883|SUPERIORITY||Odds Ratio (OR)|2.61|||||TWO_SIDED|95.0|1.81|3.75||||||Reduction from Baseline = 100%||3.75|1.81|
70951893|NCT02614183|141404884|SUPERIORITY||Mean Difference (Final Values)|7.74|STANDARD_ERROR_OF_MEAN|1.29|<|0.001|TWO_SIDED|95.0|5.2|10.28|||Mixed Models Analysis|||||10.28|5.20|<.001
70951894|NCT02614183|141404884|SUPERIORITY||Mean Difference (Final Values)|7.4|STANDARD_ERROR_OF_MEAN|1.31|<|0.001|TWO_SIDED|95.0|4.83|9.97|||Mixed Models Analysis|||||9.97|4.83|<.001
70951895|NCT02614183|141404885|SUPERIORITY||Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.28|-1.33|||Mixed Models Analysis|||||-1.33|-2.28|<.001
70951896|NCT02614183|141404885|SUPERIORITY||Odds Ratio (OR)|-1.61|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.09|-1.14|||Mixed Models Analysis|||||-1.14|-2.09|<.001
70951897|NCT02614183|141404886|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.52|-0.12|||Mixed Models Analysis|||||-0.12|-0.52|<.001
70951898|NCT02614183|141404886|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.48|-0.07|||Mixed Models Analysis|||||-0.07|-0.48|<.001
70951899|NCT02614183|141404887|SUPERIORITY||Mean Difference (Final Values)|-13.98|STANDARD_ERROR_OF_MEAN|2.55|<|0.001|TWO_SIDED|95.0|-18.99|-8.97|||Mixed Models Analysis|||||-8.97|-18.99|<.001
71143813|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.439||||0.0009||95.0|1.005|3.872|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.872|1.005|0.0009
71143814|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.461||||0.0013|TWO_SIDED|95.0|0.964|3.958|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.958|0.964|0.0013
71143815|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.474||||0.0016|TWO_SIDED|95.0|0.942|4.006|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.006|0.942|0.0016
70951900|NCT02614183|141404887|SUPERIORITY||Mean Difference (Final Values)|-13.64|STANDARD_ERROR_OF_MEAN|2.57|<|0.001|TWO_SIDED|95.0|-18.68|-8.6|||Mixed Models Analysis|||||-8.60|-18.68|<.001
70951901|NCT02614183|141404888|SUPERIORITY||Mean Difference (Final Values)|-6.29|STANDARD_ERROR_OF_MEAN|1.61|<|0.001|TWO_SIDED|95.0|-9.45|-3.13|||Mixed Models Analysis|||||-3.13|-9.45|<.001
70951902|NCT02614183|141404888|SUPERIORITY||Mean Difference (Final Values)|-5.19|STANDARD_ERROR_OF_MEAN|1.63|<|0.001|TWO_SIDED|95.0|-8.39|-1.98|||Mixed Models Analysis|||||-1.98|-8.39|<.001
70951903|NCT02614183|141404889|SUPERIORITY||||||<|0.16|||||||Fisher Exact|||TE ADA Positive.||||<.160
70951904|NCT02614183|141404889|SUPERIORITY|||||||0.02|||||||Fisher Exact|||TE ADA Positive.||||.020
70951905|NCT02614183|141404889|SUPERIORITY|||||||0.131|||||||Fisher Exact|||Neutralizing Antibodies.||||.131
70951906|NCT02614183|141404889|SUPERIORITY|||||||0.009|||||||Fisher Exact|||Neutralizing Antibodies.||||.009
70951907|NCT03838731|141404892|SUPERIORITY||Hazard Ratio (HR)|0.36|||=|0.0083|TWO_SIDED|95.0|0.17|0.77|||Cox Proportional Hazard|||||0.77|0.17|= 0.0083
70951908|NCT03838731|141404893|SUPERIORITY||Hazard Ratio (HR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.12|0.48|||Cox Hazard Model|||Day 29||0.48|0.12|< 0.0001
70951909|NCT03838731|141404893|SUPERIORITY||Hazard Ratio (HR)|0.45|||=|0.0222||95.0|0.22|0.89|||Cox Hazard Model|||Day 57||0.89|0.22|= 0.0222
70951910|NCT03838731|141404893|SUPERIORITY||Hazard Ratio (HR)|0.27|||=|0.0003||95.0|0.13|0.56|||Cox Hazard Model|||Day 85||0.56|0.13|= 0.0003
70951911|NCT03838731|141404894|SUPERIORITY|Day 8|LS Mean Difference|13.56|STANDARD_ERROR_OF_MEAN|3.59|<|0.001|TWO_SIDED|95.0|6.35|20.77|||MMRM|||||20.77|6.35|<0.001
70951912|NCT03838731|141404894|SUPERIORITY|Day 29|LS Mean Difference|16.21|STANDARD_ERROR_OF_MEAN|4.97|=|0.002|TWO_SIDED|95.0|6.18|26.24|||MMRM|||||26.24|6.18|= 0.002
70951913|NCT03838731|141404894|SUPERIORITY|Day 57|LS Mean Difference|12.3|STANDARD_ERROR_OF_MEAN|4.94|=|0.016|TWO_SIDED|95.0|2.4|22.2|||MMRM|||||22.20|2.40|= 0.016
70951914|NCT03838731|141404894|SUPERIORITY|Day 85|LS Mean Difference|12.54|STANDARD_ERROR_OF_MEAN|4.54|=|0.008|TWO_SIDED|95.0|3.43|21.65|||MMRM|||||21.65|3.43|= 0.008
70951915|NCT03838731|141404895|SUPERIORITY||LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|0.21|0.53|||MMRM|||Day 8||0.53|0.21|< 0.001
70951916|NCT03838731|141404895|SUPERIORITY||LS Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|0.23|0.68|||MMRM|||Day 29||0.68|0.23|<0.001
70951917|NCT03838731|141404895|SUPERIORITY||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.11|=|0.002|TWO_SIDED|95.0|0.13|0.55|||MMRM|||Day 57||0.55|0.13|= 0.002
70951918|NCT03838731|141404895|SUPERIORITY||LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.11|=|0.002|TWO_SIDED|95.0|0.15|0.47|||MMRM|||Day 85||0.47|0.15|= 0.002
70951919|NCT03838731|141404896|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.53|=|0.675|TWO_SIDED|95.0|-0.85|1.29|||MMRM|||Day 8||1.29|-0.85|= 0.675
70951920|NCT03838731|141404896|SUPERIORITY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.51|=|0.182|TWO_SIDED|95.0|-1.7|0.33|||MMRM|||Day 29||0.33|-1.70|= 0.182
70951921|NCT03838731|141404896|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.61|=|0.866|TWO_SIDED|95.0|-1.12|1.32|||MMRM|||Day 57||1.32|-1.12|= 0.866
70868995|NCT01606007|141223831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.0|STANDARD_ERROR_OF_MEAN|4.914|<|0.0001|TWO_SIDED|95.0|-53.7|-34.3||Each secondary endpoint was tested at alpha=0.05; significance was claimed only if Saxagliptin+Dapagliflozin+Metformin was superior to both Saxagliptin+Metformin and Dapagliflozin+Metformin.|ANCOVA|||LOCF||-34.3|-53.7|<0.0001
71143816|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.496||||0.0022|TWO_SIDED|95.0|0.901|4.092|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.092|0.901|0.0022
71143817|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.509||||0.0026|TWO_SIDED|95.0|0.878|4.14|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.140|0.878|0.0026
71143818|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.531||||0.0034|TWO_SIDED|95.0|0.836|4.226|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.226|0.836|0.0034
71143819|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.544||||0.004|TWO_SIDED|95.0|0.813|4.274|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.274|0.813|0.0040
71143820|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.566||||0.0051|TWO_SIDED|95.0|0.772|4.361|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.361|0.772|0.0051
71143821|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.579||||0.0058|TWO_SIDED|95.0|0.748|4.41|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.410|0.748|0.0058
71143822|NCT00083889|141781649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.602||||0.0071|TWO_SIDED|95.0|0.706|4.497|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.497|0.706|0.0071
71143823|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.165|||<|0.0001|TWO_SIDED|95.0|2.234|4.095|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.095|2.234|<.0001
70951922|NCT03838731|141404896|SUPERIORITY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.6|=|0.146|TWO_SIDED|95.0|-2.08|0.32|||MMRM|||Day 85||0.32|-2.08|= 0.146
70951923|NCT03838731|141404897|SUPERIORITY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.24|=|0.572|TWO_SIDED|95.0|-0.35|0.63|||MMRM|||Day 8||0.63|-0.35|= 0.572
70951924|NCT03838731|141404897|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2|=|0.997|TWO_SIDED|95.0|-0.41|0.41|||MMRM|||Day 29||0.41|-0.41|= 0.997
70951925|NCT03838731|141404897|SUPERIORITY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.21|=|0.756|TWO_SIDED|95.0|-0.36|0.49|||MMRM|||Day 57||0.49|-0.36|= 0.756
71143824|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.205|||<|0.0001|TWO_SIDED|95.0|2.318|4.092|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.092|2.318|<.0001
70951926|NCT03838731|141404897|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.15|=|0.333|TWO_SIDED|95.0|-0.46|0.16|||MMRM|||Day 85||0.16|-0.46|= 0.333
70951927|NCT03838731|141404898|SUPERIORITY||LS Mean Difference|39.5|STANDARD_ERROR_OF_MEAN|12.5|=|0.003|TWO_SIDED|95.0|14.36|64.65|||MMRM|||Day 8||64.65|14.36|= 0.003
70951928|NCT03838731|141404898|SUPERIORITY||LS Mean Difference|54.07|STANDARD_ERROR_OF_MEAN|11.97|<|0.001|TWO_SIDED|95.0|30.01|78.12|||MMRM|||Day 29||78.12|30.01|< 0.001
70951929|NCT03838731|141404898|SUPERIORITY||LS Mean Difference|33.44|STANDARD_ERROR_OF_MEAN|14.28|=|0.023|TWO_SIDED|95.0|4.79|62.08|||MMRM|||Day 57||62.08|4.79|= 0.023
70868996|NCT01606007|141223831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.1|STANDARD_ERROR_OF_MEAN|4.923||0.0639|TWO_SIDED|95.0|-18.8|0.5||Each secondary endpoint was tested at alpha=0.05; significance testing stops at the endpoint where p-value\>0.05.|ANCOVA|||LOCF||0.5|-18.8|0.0639
70951930|NCT03838731|141404898|SUPERIORITY||LS Mean Difference|41.1|STANDARD_ERROR_OF_MEAN|12.92|=|0.003|TWO_SIDED|95.0|15.1|67.09|||MMRM|||Day 85||67.09|15.10|= 0.003
70951931|NCT03838731|141404899|SUPERIORITY||LS Mean Difference|205.43|STANDARD_ERROR_OF_MEAN|102.09|=|0.049|TWO_SIDED|95.0|0.69|410.17|||MMRM|||Day 8||410.17|0.69|= 0.049
70951932|NCT03838731|141404899|SUPERIORITY||LS Mean Difference|244.6|STANDARD_ERROR_OF_MEAN|99.05|=|0.017|TWO_SIDED|95.0|45.6|443.59|||MMRM|||Day 29||443.59|45.60|= 0.017
70951933|NCT03838731|141404899|SUPERIORITY||LS Mean Difference|183.03|STANDARD_ERROR_OF_MEAN|96.91|=|0.064|TWO_SIDED|95.0|-11.29|377.35|||MMRM|||Day 57||377.35|-11.29|= 0.064
70951934|NCT03838731|141404899|SUPERIORITY||LS Mean Difference|241.01|STANDARD_ERROR_OF_MEAN|114.0|=|0.039|TWO_SIDED|95.0|12.44|469.57|||MMRM|||Day 85||469.57|12.44|= 0.039
70951935|NCT02304705|141404960|SUPERIORITY|||||||0.052|||||||t-test, 2 sided|||||||.052
70951936|NCT00770029|141404974|SUPERIORITY_OR_OTHER||Difference response rate|0.6|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001|TWO_SIDED|95.0|0.52|0.68|||Fisher Exact|||The efficacy of the treatment was confirmed if H0 was rejected at a given α of 5%, that means if the two sided p-value was ≤0.05. Power of 90%||0.68|0.52|<0.0001
70951937|NCT01174446|141404985|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence will be established if 90% C.I. of ratio is contained completely in the margins of equivalence of 0.8 to 1.25.|Ratio of Geometric Means|1.063|||||TWO_SIDED|90.0|1.03|1.09||||||||1.09|1.03|
70951938|NCT01174446|141405012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.779||95.0|||||Paired t-test|||||||0.7790
70868997|NCT01606007|141223832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.8|STANDARD_ERROR_OF_MEAN|3.988|||TWO_SIDED|95.0|-31.6|-15.9|||||ANCOVA was applied for comparison, but p-value was not reported because at least one prior test in the hierarchical testing procedure yielded p-value\>0.05.|||-15.9|-31.6|
70951939|NCT01174446|141405012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8999||95.0|||||Paired t-test|||||||0.8999
70951940|NCT01174446|141405013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||95.0|||||Paired t-test|||||||0.0056
70951941|NCT01174446|141405013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.413||95.0|||||Paired t-test|||||||0.4130
70951942|NCT01174446|141405014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9059||95.0|||||Paired t-test|||||||0.9059
70951943|NCT01174446|141405014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4098||95.0|||||Paired t-test|||||||0.4098
70951944|NCT01174446|141405015|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0189||95.0|||||Paired t-test|||||||0.0189
70951945|NCT01174446|141405015|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2974||95.0|||||Paired t-test|||||||0.2974
70951946|NCT01174446|141405016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2009||95.0|||||Paired t-test|||||||0.2009
70951947|NCT01174446|141405016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3552||95.0|||||Paired t-test|||||||0.3552
70951948|NCT01174446|141405017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5143||95.0|||||Paired t-test|||||||0.5143
70951949|NCT01174446|141405017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9223||95.0|||||Paired t-test|||||||0.9223
70951950|NCT01174446|141405018|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0162||95.0|||||Paired t-test|||||||0.0162
70951951|NCT01174446|141405018|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3176||95.0|||||Paired t-test|||||||0.3176
70951952|NCT01174446|141405019|SUPERIORITY_OR_OTHER_LEGACY|||||||0.821||95.0|||||Paired t-test|||||||0.8210
70951953|NCT01174446|141405019|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5565||95.0|||||Paired t-test|||||||0.5565
70951954|NCT01174446|141405020|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0146||95.0|||||Paired t-test|||||||0.0146
70951955|NCT01174446|141405020|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4048||95.0|||||Paired t-test|||||||0.4048
70868998|NCT01606007|141223832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|3.957|||TWO_SIDED|95.0|-13.8|1.7|||||ANCOVA was applied for comparison, but p-value was not reported because at least one prior test in the hierarchical testing procedure yielded p-value\>0.05.|||1.7|-13.8|
70868999|NCT01606007|141223833|SUPERIORITY_OR_OTHER||Mean difference in percentages|23.1|STANDARD_ERROR_OF_MEAN|4.282|||TWO_SIDED|95.0|14.7|31.5|||||Modified Logistic Regression was applied for comparison, but p-value was not reported because at least one prior test in the hierarchical testing procedure yielded p-value\>0.05.|||31.5|14.7|
70869000|NCT01606007|141223833|SUPERIORITY_OR_OTHER||Mean difference in percentages|19.1|STANDARD_ERROR_OF_MEAN|4.587|||TWO_SIDED|95.0|10.1|28.1|||||Modified Logistic Regression was applied for comparison, but p-value was not reported because at least one prior test in the hierarchical testing procedure yielded p-value\>0.05.|||28.1|10.1|
70869001|NCT01606007|141223834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05|STANDARD_ERROR_OF_MEAN|0.3451|||TWO_SIDED|95.0|-2.73|-1.37|||||ANCOVA was applied for comparison, but p-value was not reported because at least one prior test in the hierarchical testing procedure yielded p-value\>0.05.|||-1.37|-2.73|
70869002|NCT01517711|141223835|SUPERIORITY_OR_OTHER_LEGACY|||||||0.286||||||P value is for overall post-randomization CAPS score|ANOVA|||Women were excluded from analysis because of the small sample size and unequal distribution across groups.||||0.286
70869003|NCT01517711|141223836|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.1|||||||ANOVA|||||||<0.10
70869004|NCT01517711|141223837|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.03|||||||ANOVA|||Analysis is for sleep only (men)||||=0.03
70869005|NCT00555971|141223842|EQUIVALENCE|This was a statistical analysis to address the null hypothesis that there was no difference between treatment and placebo groups.||||||0.036|||||||Fisher Exact|||||||0.036
70869006|NCT02571777|141223856|SUPERIORITY||LS Mean|0.065|STANDARD_ERROR_OF_MEAN|0.0176|<|0.001|TWO_SIDED|95.0|0.031|0.099|||Mixed Model for Repeated Measures (MMRM)|||||0.099|0.031|<0.001
70869007|NCT02571777|141223856|SUPERIORITY||LS Mean|0.076|STANDARD_ERROR_OF_MEAN|0.0176|<|0.001|TWO_SIDED|95.0|0.041|0.111|||MMRM|||||0.111|0.041|<0.001
70869008|NCT02571777|141223857|SUPERIORITY||LS Mean|0.014|STANDARD_ERROR_OF_MEAN|0.0406||0.729|TWO_SIDED|95.0|-0.066|0.094|||MMRM|||Week 26||0.094|-0.066|0.729
70951956|NCT01174446|141405021|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1258||95.0|||||Paired t-test|||||||0.1258
70951957|NCT01174446|141405021|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2567||95.0|||||Paired t-test|||||||0.2567
70951958|NCT01174446|141405022|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1048||95.0|||||Paired t-test|||||||0.1048
70951959|NCT01174446|141405022|SUPERIORITY_OR_OTHER_LEGACY|||||||0.641||95.0|||||Paired t-test|||||||0.6410
70869009|NCT02571777|141223857|SUPERIORITY||LS Mean|-0.086|STANDARD_ERROR_OF_MEAN|0.0404||0.034|TWO_SIDED|95.0|-0.165|-0.006|||MMRM|||Week 26||-0.006|-0.165|0.034
70869010|NCT02571777|141223857|SUPERIORITY||LS Mean|-0.071|STANDARD_ERROR_OF_MEAN|0.0409||0.085|TWO_SIDED|95.0|-0.151|0.01|||MMRM|||Week 26||0.010|-0.151|0.085
70869011|NCT02571777|141223857|SUPERIORITY||LS Mean|-0.084|STANDARD_ERROR_OF_MEAN|0.0406||0.038|TWO_SIDED|95.0|-0.164|-0.005|||MMRM|||Week 26||-0.005|-0.164|0.038
70869012|NCT02571777|141223857|SUPERIORITY||LS Mean|-0.059|STANDARD_ERROR_OF_MEAN|0.0415||0.157|TWO_SIDED|95.0|-0.14|0.023|||MMRM|||Week 52||0.023|-0.140|0.157
70869013|NCT02571777|141223857|SUPERIORITY||LS Mean|-0.121|STANDARD_ERROR_OF_MEAN|0.0414||0.003|TWO_SIDED|95.0|-0.202|-0.04|||MMRM|||Week 52||-0.040|-0.202|0.003
70869014|NCT02571777|141223857|SUPERIORITY||LS Mean|-0.01|STANDARD_ERROR_OF_MEAN|0.042||0.814|TWO_SIDED|95.0|-0.092|0.072|||MMRM|||Week 52||0.072|-0.092|0.814
70869015|NCT02571777|141223857|SUPERIORITY||LS Mean|0.008|STANDARD_ERROR_OF_MEAN|0.0416||0.845|TWO_SIDED|95.0|-0.073|0.09|||MMRM|||Week 52||0.090|-0.073|0.845
70869016|NCT02571777|141223858|SUPERIORITY||LS Mean|0.119|STANDARD_ERROR_OF_MEAN|0.0177|<|0.001|TWO_SIDED|95.0|0.085|0.154|||MMRM|||||0.154|0.085|<0.001
70869017|NCT02571777|141223858|SUPERIORITY||LS Mean|0.099|STANDARD_ERROR_OF_MEAN|0.0177|<|0.001|TWO_SIDED|95.0|0.064|0.133|||MMRM|||||0.133|0.064|<0.001
70869018|NCT02571777|141223859|SUPERIORITY||LS Mean|0.086|STANDARD_ERROR_OF_MEAN|0.0176|<|0.001|TWO_SIDED|95.0|0.051|0.12|||MMRM|||||0.120|0.051|<0.001
70869019|NCT02571777|141223859|SUPERIORITY||LS Mean|0.145|STANDARD_ERROR_OF_MEAN|0.0178|<|0.001|TWO_SIDED|95.0|0.111|0.18|||MMRM|||||0.180|0.111|<0.001
70869020|NCT02571777|141223859|SUPERIORITY||LS Mean|0.062|STANDARD_ERROR_OF_MEAN|0.0178|<|0.001|TWO_SIDED|95.0|0.027|0.096|||MMRM|||||0.096|0.027|<0.001
70869021|NCT02571777|141223859|SUPERIORITY||LS Mean|0.087|STANDARD_ERROR_OF_MEAN|0.0179|<|0.001|TWO_SIDED|95.0|0.052|0.122|||MMRM|||||0.122|0.052|<0.001
70869022|NCT02571777|141223860|SUPERIORITY||LS Mean|0.073|STANDARD_ERROR_OF_MEAN|0.0218|<|0.001|TWO_SIDED|95.0|0.03|0.116|||MMRM|||Week 4||0.116|0.030|<0.001
70869023|NCT02571777|141223860|SUPERIORITY||LS Mean|0.139|STANDARD_ERROR_OF_MEAN|0.0217|<|0.001|TWO_SIDED|95.0|0.096|0.181|||MMRM|||Week 4||0.181|0.096|<0.001
70869024|NCT02571777|141223860|SUPERIORITY||LS Mean|0.039|STANDARD_ERROR_OF_MEAN|0.022||0.074|TWO_SIDED|95.0|-0.004|0.082|||MMRM|||Week 4||0.082|-0.004|0.074
70869025|NCT02571777|141223860|SUPERIORITY||LS Mean|0.108|STANDARD_ERROR_OF_MEAN|0.0219|<|0.001|TWO_SIDED|95.0|0.065|0.15|||MMRM|||Week 4||0.150|0.065|<0.001
70869026|NCT02571777|141223860|SUPERIORITY||LS Mean|0.056|STANDARD_ERROR_OF_MEAN|0.0219||0.01|TWO_SIDED|95.0|0.014|0.099|||MMRM|||Week 12||0.099|0.014|0.010
70869027|NCT02571777|141223860|SUPERIORITY||LS Mean|0.102|STANDARD_ERROR_OF_MEAN|0.0218|<|0.001|TWO_SIDED|95.0|0.059|0.145|||MMRM|||Week 12||0.145|0.059|<0.001
70869028|NCT02571777|141223860|SUPERIORITY||LS Mean|0.05|STANDARD_ERROR_OF_MEAN|0.0221||0.022|TWO_SIDED|95.0|0.007|0.094|||MMRM|||Week 12||0.094|0.007|0.022
70869029|NCT02571777|141223860|SUPERIORITY||LS Mean|0.099|STANDARD_ERROR_OF_MEAN|0.022|<|0.001|TWO_SIDED|95.0|0.056|0.142|||MMRM|||Week 12||0.142|0.056|<0.001
70869030|NCT02571777|141223861|SUPERIORITY||LS Mean|0.095|STANDARD_ERROR_OF_MEAN|0.0254|<|0.001|TWO_SIDED|95.0|0.045|0.145|||MMRM|||||0.145|0.045|<0.001
70869031|NCT02571777|141223861|SUPERIORITY||LS Mean|0.147|STANDARD_ERROR_OF_MEAN|0.0256|<|0.001|TWO_SIDED|95.0|0.097|0.198|||MMRM|||||0.198|0.097|<0.001
70869032|NCT02571777|141223861|SUPERIORITY||LS Mean|0.049|STANDARD_ERROR_OF_MEAN|0.0256||0.057|TWO_SIDED|95.0|-0.001|0.099|||MMRM|||||0.099|-0.001|0.057
70951960|NCT01174446|141405023|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0663||95.0|||||Paired t-test|||||||0.0663
70951961|NCT01174446|141405023|SUPERIORITY_OR_OTHER_LEGACY|||||||0.489||95.0|||||Paired t-test|||||||0.4890
70951962|NCT01174446|141405024|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0562||95.0|||||Paired t-test|||||||0.0562
70951963|NCT01174446|141405024|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3864||95.0|||||Paired t-test|||||||0.3864
70951964|NCT01174446|141405025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5792||95.0|||||Paired t-test|||||||0.5792
70951965|NCT01174446|141405026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4208||95.0|||||Paired t-test|||||||0.4208
70951966|NCT01174446|141405027|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0|||||Paired t-test|||||||0.5000
70951967|NCT01174446|141405028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0633||95.0|||||Paired t-test|||||||0.0633
71143825|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.228|||<|0.0001|TWO_SIDED|95.0|2.358|4.097|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects)||4.097|2.358|<.0001
71143826|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.268|||<|0.0001|TWO_SIDED|95.0|2.418|4.119|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.119|2.418|<.0001
70951968|NCT01174446|141405028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9363||95.0|||||Paired t-test|||||||0.9363
70951969|NCT00847626|141405036|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.0|||<|0.001|TWO_SIDED|95.0|-15.8|-9.5||Tested at 5% significance level.|ANCOVA|||Analysis of covariance model (ANCOVA) using treatment as a fixed effect and baseline as a covariate was performed. Results for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD pool were obtained using contrast with coefficients of 0.5 for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and 0.5 for Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD from the ANCOVA model.||-9.5|-15.8|<0.001
70951970|NCT00847626|141405036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.8|||<|0.001|TWO_SIDED|95.0|-16.7|-10.9||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed. Results for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD pool were obtained using contrast with coefficients of 0.5 for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and 0.5 for Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD from the ANCOVA model.||-10.9|-16.7|<0.001
70951971|NCT00847626|141405037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.7|||<|0.001|TWO_SIDED|95.0|-16.2|-9.2||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-9.2|-16.2|<0.001
70951972|NCT00847626|141405037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.9|||<|0.001|TWO_SIDED|95.0|-13.4|-6.4||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-6.4|-13.4|<0.001
70951973|NCT00847626|141405037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.7|||<|0.001|TWO_SIDED|95.0|-19.2|-12.1||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-12.1|-19.2|<0.001
70951974|NCT00847626|141405037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4|||<|0.001|TWO_SIDED|95.0|-15.8|-8.9||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-8.9|-15.8|<0.001
70951975|NCT00847626|141405037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.8|||<|0.001|TWO_SIDED|95.0|-19.3|-12.3||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-12.3|-19.3|<0.001
70951976|NCT00847626|141405037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.0|||<|0.001|TWO_SIDED|95.0|-16.5|-9.5||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-9.5|-16.5|<0.001
70951977|NCT00847626|141405037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.0|||<|0.001|TWO_SIDED|95.0|-17.5|-10.5||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-10.5|-17.5|<0.001
70951978|NCT00847626|141405037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.2|||<|0.001|TWO_SIDED|95.0|-20.6|-13.7||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-13.7|-20.6|<0.001
70951979|NCT00847626|141405037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.5|||<|0.001|TWO_SIDED|95.0|-17.0|-9.9||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-9.9|-17.0|<0.001
70951980|NCT00847626|141405037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2|||<|0.001|TWO_SIDED|95.0|-19.7|-12.7||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-12.7|-19.7|<0.001
70951981|NCT00847626|141405037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.8|||<|0.001|TWO_SIDED|95.0|-16.3|-9.3||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-9.3|-16.3|<0.001
70951982|NCT00847626|141405037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.0|||<|0.001|TWO_SIDED|95.0|-19.4|-12.6||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-12.6|-19.4|<0.001
70951983|NCT00847626|141405038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8||||0.255|TWO_SIDED|95.0|-13.0|3.5||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed. Results for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and Azilsartan Medoxomil 80mg/Chlorthalidone 25 mg QD pool were obtained using contrast with coefficients of 0.5 for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and 0.5 for Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD from the ANCOVA model.||3.5|-13.0|0.255
70951984|NCT00847626|141405038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.2|||<|0.001|TWO_SIDED|95.0|-25.9|-10.6||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed. Results for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and Azilsartan Medoxomil 80mg/Chlorthalidone 25 mg QD pool were obtained using contrast with coefficients of 0.5 for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and 0.5 for Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD from the ANCOVA model.||-10.6|-25.9|<0.001
70951985|NCT00847626|141405051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.3|||<|0.001|TWO_SIDED|95.0|-13.6|-7.0||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-7.0|-13.6|< 0.001
70951986|NCT00847626|141405051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4|||<|0.001|TWO_SIDED|95.0|-13.7|-7.0||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-7.0|-13.7|<0.001
70951987|NCT00847626|141405051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.8|||<|0.001|TWO_SIDED|95.0|-15.1|-8.4||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-8.4|-15.1|<0.001
71143827|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.291|||<|0.0001|TWO_SIDED|95.0|2.443|4.139|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.139|2.443|<.0001
71143828|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.331|||<|0.0001|TWO_SIDED|95.0|2.474|4.189|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.189|2.474|<.0001
71143829|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.354|||<|0.0001||95.0|2.484|4.224|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.224|2.484|<.0001
71143830|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.395|||<|0.0001|TWO_SIDED|95.0|2.489|4.3|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.300|2.489|<.0001
70951988|NCT00847626|141405051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.9|||<|0.001|TWO_SIDED|95.0|-17.3|-10.6||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-10.6|-17.3|<0.001
70869033|NCT02571777|141223861|SUPERIORITY||LS Mean|0.056|STANDARD_ERROR_OF_MEAN|0.0258||0.029|TWO_SIDED|95.0|0.006|0.107|||MMRM|||||0.107|0.006|0.029
70951989|NCT00847626|141405051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||<|0.001|TWO_SIDED|95.0|-17.1|-10.3||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-10.3|-17.1|<0.001
70869034|NCT02571777|141223862|SUPERIORITY||LS Mean|18.2|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|13.2|23.3|||Linear Mixed Model (LMM)|||Week 26 - Mean morning PEF||23.3|13.2|<0.001
70951990|NCT00847626|141405051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.0|||<|0.001|TWO_SIDED|95.0|-15.4|-8.7||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-8.7|-15.4|<0.001
70951991|NCT00847626|141405051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9|||<|0.001|TWO_SIDED|95.0|-14.2|-7.6||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-7.6|-14.2|<0.001
70951992|NCT00847626|141405051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.2|||<|0.001|TWO_SIDED|95.0|-17.6|-10.9||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-10.9|-17.6|<0.001
70951993|NCT00847626|141405051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6|||<|0.001|TWO_SIDED|95.0|-15.0|-8.3||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-8.3|-15.0|<0.001
70951994|NCT00847626|141405051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.0|||<|0.001|TWO_SIDED|95.0|-20.4|-13.6||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-13.6|-20.4|<0.001
70951995|NCT00847626|141405051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.2|||<|0.001|TWO_SIDED|95.0|-14.7|-7.8||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-7.8|-14.7|<0.001
70951996|NCT00847626|141405051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.8|||<|0.001|TWO_SIDED|95.0|-16.2|-9.4||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-9.4|-16.2|<0.001
70951997|NCT01294397|141405085|SUPERIORITY_OR_OTHER||Least Squares Mean Ratio of Day 22/Day 1|0.96|||||TWO_SIDED|90.0|0.85|1.08|||||Two one-sided tests|Log-transformed AUC0-168 was analyzed with a mixed-effects model with treatment as the fixed effect and subject as the random effect. The mean difference between day 22 and day 1 was expressed as a percentage of the reference (day 1). The mean differences and the 90% CIs were back transformed to produce the ratio (day 22 vs. day 1) of the geometric means and the 90% CIs. If the CI for the ratio was within the standard acceptance range of 0.80 to 1.25, absence of an interaction was concluded.||1.08|0.85|
70951998|NCT01294397|141405086|SUPERIORITY_OR_OTHER||Least Squares Mean Ratio of Day 22/Day 1|0.92|||||TWO_SIDED|90.0|0.81|1.05|||||Two one-sided tests|Log-transformed Cmax was analyzed with a mixed-effects model with treatment as the fixed effect and subject as the random effect. The mean difference between day 22 and day 1 was expressed as a percentage of the reference (day 1). The mean differences and the 90% CIs were back transformed to produce the ratio (day 22 vs. day 1) of the geometric means and the 90% CIs. If the CI for the ratio was within the standard acceptance range of 0.80 to 1.25, absence of an interaction was concluded.||1.05|0.81|
70951999|NCT04421950|141405161|OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
70952000|NCT01725126|141405208|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|0.19|||||TWO_SIDED|95.0|-1.38|1.75|||ANCOVA|Repeated measures analysis of variance was used with terms for treatment, visit, treatment by visit interaction and Baseline.|Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B-Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in body weight.||1.75|-1.38|
70952001|NCT01725126|141405208|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|1.08|||||TWO_SIDED|95.0|-0.2|2.36|||ANCOVA|Repeated measures analysis of variance was used with terms for treatment, visit, treatment by visit interaction and Baseline.|Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in body weight.||2.36|-0.20|
70952002|NCT01725126|141405209|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-1.64|1.87|||ANCOVA|Repeated measures analysis of variance was used with terms for treatment, visit, treatment by visit interaction and Baseline.|Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B-Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 percent change from Baseline in body weight.||1.87|-1.64|
70952003|NCT01725126|141405209|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|1.26|||||TWO_SIDED|95.0|-0.24|2.75|||ANCOVA|Repeated measures analysis of variance was used with terms for treatment, visit, treatment by visit interaction and Baseline.|Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 percent change from Baseline in body weight.||2.75|-0.24|
70952004|NCT01725126|141405210|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.182|||||TWO_SIDED|95.0|-1.694|1.331|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B-Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in AUC (0-4 hour) weighted mean glucose.||1.331|-1.694|
70952005|NCT01725126|141405210|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.356|||||TWO_SIDED|95.0|-1.409|0.698|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B-Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in AUC (0-24 hour) weighted mean glucose.||0.698|-1.409|
70952006|NCT01725126|141405210|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.853|||||TWO_SIDED|95.0|-2.232|0.526|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in AUC (0-4 hour) weighted mean glucose.||0.526|-2.232|
70952007|NCT01725126|141405210|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-1.219|||||TWO_SIDED|95.0|-2.447|0.009|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in AUC (0-24 hour) weighted mean glucose.||0.009|-2.447|
70952008|NCT01725126|141405211|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|0.155|||||TWO_SIDED|95.0|-1.277|1.587|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B -Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in fasting glucose.||1.587|-1.277|
70869035|NCT02571777|141223862|SUPERIORITY||LS Mean|35.3|STANDARD_ERROR_OF_MEAN|2.58|<|0.001|TWO_SIDED|95.0|30.2|40.3|||LMM|||Week 26 - Mean morning PEF||40.3|30.2|<0.001
70869036|NCT02571777|141223862|SUPERIORITY||LS Mean|14.9|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|9.8|20.0|||LMM|||Week 26 - Mean morning PEF||20.0|9.8|<0.001
70869037|NCT02571777|141223862|SUPERIORITY||LS Mean|28.0|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|22.9|33.1|||LMM|||Week 26 - Mean morning PEF||33.1|22.9|<0.001
70869038|NCT02571777|141223862|SUPERIORITY||LS Mean|16.8|STANDARD_ERROR_OF_MEAN|2.53|<|0.001|TWO_SIDED|95.0|11.8|21.7|||LMM|||Week 26 - Mean evening PEF||21.7|11.8|<0.001
70869039|NCT02571777|141223862|SUPERIORITY||LS Mean|29.1|STANDARD_ERROR_OF_MEAN|2.53|<|0.001|TWO_SIDED|95.0|24.2|34.1|||LMM|||Week 26 - Mean evening PEF||34.1|24.2|<0.001
71143831|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.417|||<|0.0001|TWO_SIDED|95.0|2.486|4.348|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.348|2.486|<.0001
71143832|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.458|||<|0.0001|TWO_SIDED|95.0|2.469|4.446|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.446|2.469|<.0001
71143833|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.48|||<|0.0001|TWO_SIDED|95.0|2.455|4.505|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.505|2.455|<.0001
71143834|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.521|||<|0.0001|TWO_SIDED|95.0|2.422|4.62|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.620|2.422|<.0001
71143835|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.543|||<|0.0001|TWO_SIDED|95.0|2.399|4.687|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.687|2.399|<.0001
71143836|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.584|||<|0.0001||95.0|2.354|4.814|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects)||4.814|2.354|<.0001
71143837|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.606|||<|0.0001|TWO_SIDED|95.0|2.326|4.887|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.887|2.326|<.0001
71143838|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.647|||<|0.0001|TWO_SIDED|95.0|2.272|5.022|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.022|2.272|<.0001
71143839|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.669|||<|0.0001|TWO_SIDED|95.0|2.24|5.099|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.099|2.240|<.0001
71143840|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.71|||<|0.0001|TWO_SIDED|95.0|2.18|5.24|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.240|2.180|<.0001
71143841|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.733|||<|0.0001|TWO_SIDED|95.0|2.145|5.32|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.320|2.145|<.0001
71143842|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.773|||<|0.0001|TWO_SIDED|95.0|2.08|5.466|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.466|2.080|<.0001
70869040|NCT02571777|141223862|SUPERIORITY||LS Mean|14.1|STANDARD_ERROR_OF_MEAN|2.55|<|0.001|TWO_SIDED|95.0|9.1|19.1|||LMM|||Week 26 - Mean evening PEF||19.1|9.1|<0.001
70869041|NCT02571777|141223862|SUPERIORITY||LS Mean|24.3|STANDARD_ERROR_OF_MEAN|2.54|<|0.001|TWO_SIDED|95.0|19.3|29.3|||LMM|||Week 26 - Mean evening PEF||29.3|19.3|<0.001
70869042|NCT02571777|141223862|SUPERIORITY||LS Mean|18.7|STANDARD_ERROR_OF_MEAN|2.72|<|0.001|TWO_SIDED|95.0|13.4|24.1|||LMM|||Week 52 - Mean morning PEF||24.1|13.4|<0.001
70869043|NCT02571777|141223862|SUPERIORITY||LS Mean|34.8|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|29.5|40.1|||LMM|||Week 52 - Mean morning PEF||40.1|29.5|<0.001
70869044|NCT02571777|141223862|SUPERIORITY||LS Mean|15.6|STANDARD_ERROR_OF_MEAN|2.74|<|0.001|TWO_SIDED|95.0|10.2|20.9|||LMM|||Week 52 - Mean morning PEF||20.9|10.2|<0.001
70869045|NCT02571777|141223862|SUPERIORITY||LS Mean|28.5|STANDARD_ERROR_OF_MEAN|2.72|<|0.001|TWO_SIDED|95.0|23.2|33.8|||LMM|||Week 52 - Mean morning PEF||33.8|23.2|<0.001
70869046|NCT02571777|141223862|SUPERIORITY||LS Mean|17.5|STANDARD_ERROR_OF_MEAN|2.66|<|0.001|TWO_SIDED|95.0|12.3|22.8|||LMM|||Week 52 - Mean evening PEF||22.8|12.3|<0.001
70869047|NCT02571777|141223862|SUPERIORITY||LS Mean|29.5|STANDARD_ERROR_OF_MEAN|2.66|<|0.001|TWO_SIDED|95.0|24.2|34.7|||LMM|||Week 52 - Mean evening PEF||34.7|24.2|<0.001
71143843|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.796|||<|0.0001|TWO_SIDED|95.0|2.043|5.548|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.548|2.043|<.0001
71143844|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.836|||<|0.0001|TWO_SIDED|95.0|1.975|5.698|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.698|1.975|<.0001
71143845|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.859|||<|0.0001|TWO_SIDED|95.0|1.936|5.781|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.781|1.936|<.0001
70869048|NCT02571777|141223862|SUPERIORITY||LS Mean|15.0|STANDARD_ERROR_OF_MEAN|2.69|<|0.001|TWO_SIDED|95.0|9.7|20.2|||LMM|||Week 52 - Mean evening PEF||20.2|9.7|<0.001
70869049|NCT02571777|141223862|SUPERIORITY||LS Mean|25.8|STANDARD_ERROR_OF_MEAN|2.68|<|0.001|TWO_SIDED|95.0|20.5|31.0|||LMM|||Week 52 - Mean evening PEF||31.0|20.5|<0.001
70869050|NCT02571777|141223863|SUPERIORITY||LS Mean|0.2|STANDARD_ERROR_OF_MEAN|1.81||0.907|TWO_SIDED|95.0|-3.3|3.8|||LMM|||||3.8|-3.3|0.907
70869051|NCT02571777|141223863|SUPERIORITY||LS Mean|3.5|STANDARD_ERROR_OF_MEAN|1.81||0.055|TWO_SIDED|95.0|-0.1|7.0|||LMM|||||7.0|-0.1|0.055
70869052|NCT02571777|141223863|SUPERIORITY||LS Mean|0.0|STANDARD_ERROR_OF_MEAN|1.83||0.997|TWO_SIDED|95.0|-3.6|3.6|||LMM|||||3.6|-3.6|0.997
70869053|NCT02571777|141223863|SUPERIORITY||LS Mean|-0.9|STANDARD_ERROR_OF_MEAN|1.82||0.606|TWO_SIDED|95.0|-4.5|2.6|||LMM|||||2.6|-4.5|0.606
70869054|NCT02571777|141223864|SUPERIORITY||LS Mean|0.7|STANDARD_ERROR_OF_MEAN|1.78||0.712|TWO_SIDED|95.0|-2.8|4.2|||LMM|||||4.2|-2.8|0.712
70869055|NCT02571777|141223864|SUPERIORITY||LS Mean|3.7|STANDARD_ERROR_OF_MEAN|1.78||0.038|TWO_SIDED|95.0|0.2|7.2|||LMM|||||7.2|0.2|0.038
70869056|NCT02571777|141223864|SUPERIORITY||LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|1.8||0.943|TWO_SIDED|95.0|-3.7|3.4|||LMM|||||3.4|-3.7|0.943
70869057|NCT02571777|141223864|SUPERIORITY||LS Mean|-0.9|STANDARD_ERROR_OF_MEAN|1.79||0.612|TWO_SIDED|95.0|-4.4|2.6|||LMM|||||2.6|-4.4|0.612
70869058|NCT02571777|141223865|SUPERIORITY||LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|1.51||0.809|TWO_SIDED|95.0|-3.3|2.6|||LMM|||||2.6|-3.3|0.809
70869059|NCT02571777|141223865|SUPERIORITY||LS Mean|1.1|STANDARD_ERROR_OF_MEAN|1.5||0.467|TWO_SIDED|95.0|-1.9|4.0|||LMM|||||4.0|-1.9|0.467
70869060|NCT02571777|141223865|SUPERIORITY||LS Mean|1.5|STANDARD_ERROR_OF_MEAN|1.52||0.318|TWO_SIDED|95.0|-1.5|4.5|||LMM|||||4.5|-1.5|0.318
70869061|NCT02571777|141223865|SUPERIORITY||LS Mean|0.7|STANDARD_ERROR_OF_MEAN|1.51||0.64|TWO_SIDED|95.0|-2.3|3.7|||LMM|||||3.7|-2.3|0.640
70869062|NCT02571777|141223866|SUPERIORITY||LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|1.83||0.814|TWO_SIDED|95.0|-4.0|3.2|||LMM|||||3.2|-4.0|0.814
70869063|NCT02571777|141223866|SUPERIORITY||LS Mean|3.8|STANDARD_ERROR_OF_MEAN|1.83||0.036|TWO_SIDED|95.0|0.2|7.4|||LMM|||||7.4|0.2|0.036
70869064|NCT02571777|141223866|SUPERIORITY||LS Mean|3.1|STANDARD_ERROR_OF_MEAN|1.84||0.098|TWO_SIDED|95.0|-0.6|6.7|||LMM|||||6.7|-0.6|0.098
70869065|NCT02571777|141223866|SUPERIORITY||LS Mean|2.9|STANDARD_ERROR_OF_MEAN|1.84||0.118|TWO_SIDED|95.0|-0.7|6.5|||LMM|||||6.5|-0.7|0.118
70869066|NCT02571777|141223867|SUPERIORITY||LS Mean|-0.8|STANDARD_ERROR_OF_MEAN|1.74||0.645|TWO_SIDED|95.0|-4.2|2.6|||LMM|||Week 26||2.6|-4.2|0.645
70869067|NCT02571777|141223867|SUPERIORITY||LS Mean|2.9|STANDARD_ERROR_OF_MEAN|1.73||0.095|TWO_SIDED|95.0|-0.5|6.3|||LMM|||Week 26||6.3|-0.5|0.095
70869068|NCT02571777|141223867|SUPERIORITY||LS Mean|1.3|STANDARD_ERROR_OF_MEAN|1.75||0.46|TWO_SIDED|95.0|-2.1|4.7|||LMM|||Week 26||4.7|-2.1|0.460
70869069|NCT02571777|141223867|SUPERIORITY||LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|1.75||0.971|TWO_SIDED|95.0|-3.5|3.4|||LMM|||Week 26||3.4|-3.5|0.971
70869070|NCT02571777|141223867|SUPERIORITY||LS Mean|0.1|STANDARD_ERROR_OF_MEAN|1.78||0.963|TWO_SIDED|95.0|-3.4|3.6|||LMM|||Week 52||3.6|-3.4|0.963
70869071|NCT02571777|141223867|SUPERIORITY||LS Mean|3.2|STANDARD_ERROR_OF_MEAN|1.77||0.075|TWO_SIDED|95.0|-0.3|6.6|||LMM|||Week 52||6.6|-0.3|0.075
70869072|NCT02571777|141223867|SUPERIORITY||LS Mean|1.2|STANDARD_ERROR_OF_MEAN|1.79||0.517|TWO_SIDED|95.0|-2.3|4.7|||LMM|||Week 52||4.7|-2.3|0.517
70869073|NCT02571777|141223867|SUPERIORITY||LS Mean|0.1|STANDARD_ERROR_OF_MEAN|1.78||0.956|TWO_SIDED|95.0|-3.4|3.6|||LMM|||Week 52||3.6|-3.4|0.956
70952009|NCT01725126|141405211|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.524|||||TWO_SIDED|95.0|-1.939|0.892|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in fasting glucose.||0.892|-1.939|
70952010|NCT01725126|141405213|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.065|||||TWO_SIDED|95.0|-0.495|0.365|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B-Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in HbA1c.||0.365|-0.495|
70952011|NCT01725126|141405213|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.219|||||TWO_SIDED|95.0|-0.91|0.472|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in HbA1c.||0.472|-0.910|
70952012|NCT01725126|141405217|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|1.046|||||TWO_SIDED|90.0|0.729|1.5008|||Mixed Models Analysis|The PK parameter was log-transformed prior to analysis.|The difference in least squares means and corresponding confidence interval were back-transformed to form ratio of geometric least squares means (Day 42/ Day -1) and confidence interval.|Comparison of Day 42 to Day -1 in GSK2890457+Liraglutide treated participants in the Liraglutide PK Population.||1.5008|0.7290|
70952013|NCT01725126|141405218|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|1.0334|||||TWO_SIDED|90.0|0.781|1.3673|||Mixed Models Analysis|The PK parameter was log-transformed prior to analysis.|The difference in least squares means and corresponding confidence interval were back-transformed to form ratio of geometric least squares means (Day 42/ Day -1) and confidence interval.|Comparison of Day 42 to Day -1 in GSK2890457+Liraglutide treated participants in the Liraglutide PK Population.||1.3673|0.7810|
70952014|NCT01725126|141405220|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|0.675|||||TWO_SIDED|90.0|0.585|0.779|||Mixed Models Analysis|The PK parameter was log-transformed prior to analysis.|The difference in least squares means and corresponding confidence interval were back-transformed to form ratio of geometric least squares means (Day 42/ Day 1) and confidence interval.|Comparison of Day 42 to Day 1 in GSK2890457 treated participants in the PK Population.||0.779|0.585|
70952015|NCT01725126|141405221|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|0.662|||||TWO_SIDED|90.0|0.578|0.757|||Mixed Models Analysis|The PK parameter was log-transformed prior to analysis.|The difference in least squares means and corresponding confidence interval were back-transformed to form ratio of geometric least squares means (Day 42/ Day 1) and confidence interval.|Comparison of Day 42 to Day 1 in GSK2890457 treated participants in the PK Population.||0.757|0.578|
70952016|NCT01128270|141405226|SUPERIORITY_OR_OTHER||Mean of one group (2A)|1.64|STANDARD_DEVIATION|0.4|||TWO_SIDED|95.0|1.31|1.97||||Analysis applies only to Arm 2A. (Period 3)|Only arm 2A is relevant to this variable. There is no intended statistical comparison, but the point estimate for the mean level and 95% confidence interval are provided.|No comparison is relevant. The statistical method is how we obtained the point estimate and confidence interval. No test was intended.||1.97|1.31|
70952017|NCT01128270|141405227|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2432.0|STANDARD_DEVIATION|1403.0||0.0017|TWO_SIDED|95.0|1260.0|3606.0|||t-test, 2 sided|||Only relevant to Arm 2B.||3606|1260|0.0017
70952018|NCT01128270|141405228|SUPERIORITY_OR_OTHER||Mean|0.38|STANDARD_DEVIATION|0.17|||TWO_SIDED|95.0|0.24|0.51||||||Only relevant for arm 2B||0.51|0.24|
70952019|NCT03296800|141405230|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate (%)|118.66|||||TWO_SIDED|90.0|111.12|126.72|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.|Geometric LS Mean was used as PK parameters||126.72|111.12|
70952020|NCT03296800|141405230|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate (%)|119.62|||||TWO_SIDED|90.0|94.39|151.59||||||Geometric LS Mean was used as PK parameters|Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.|151.59|94.39|
70952021|NCT03296800|141405230|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate (%)|106.05|||||TWO_SIDED|90.0|88.81|126.65||||||Geometric LS Mean was used as PK parameters|Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.|126.65|88.81|
70952022|NCT03296800|141405233|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate (%)|140.98|||||TWO_SIDED|90.0|131.39|151.26|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.|Geometric LS Mean was used as PK parameters||151.26|131.39|
70952023|NCT03296800|141405233|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate (%)|86.12|||||TWO_SIDED|90.0|70.24|105.59|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.|Geometric LS Mean was used as PK parameters||105.59|70.24|
70952024|NCT03296800|141405233|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate (%)|97.93|||||TWO_SIDED|90.0|90.26|106.26|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.|Geometric LS Mean was used as PK parameters||106.26|90.26|
70869074|NCT02571777|141223868|SUPERIORITY||Odds Ratio (OR)|0.92||||0.535|TWO_SIDED|95.0|0.7|1.2|||Logistic regression model|||Week 26||1.20|0.70|0.535
70869075|NCT02571777|141223868|SUPERIORITY||Odds Ratio (OR)|1.21||||0.151|TWO_SIDED|95.0|0.93|1.57|||Logistic regression model|||Week 26||1.57|0.93|0.151
70869076|NCT02571777|141223868|SUPERIORITY||Odds Ratio (OR)|1.13||||0.38|TWO_SIDED|95.0|0.86|1.48|||Logistic regression model|||Week 26||1.48|0.86|0.380
70869077|NCT02571777|141223868|SUPERIORITY||Odds Ratio (OR)|1.2||||0.172|TWO_SIDED|95.0|0.92|1.57|||Logistic regression model|||Week 26||1.57|0.92|0.172
70869078|NCT02571777|141223868|SUPERIORITY||Odds Ratio (OR)|1.1||||0.51|TWO_SIDED|95.0|0.83|1.47|||Logistic regression model|||Week 52||1.47|0.83|0.510
70869079|NCT02571777|141223868|SUPERIORITY||Odds Ratio (OR)|1.41||||0.017|TWO_SIDED|95.0|1.06|1.86|||Logistic regression model|||Week 52||1.86|1.06|0.017
70869080|NCT02571777|141223868|SUPERIORITY||Odds Ratio (OR)|1.05||||0.744|TWO_SIDED|95.0|0.79|1.38|||Logistic regression model|||Week 52||1.38|0.79|0.744
70869081|NCT02571777|141223868|SUPERIORITY||Odds Ratio (OR)|0.99||||0.922|TWO_SIDED|95.0|0.75|1.29|||Logistic regression model|||Week 52||1.29|0.75|0.922
70869082|NCT02571777|141223869|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.371|TWO_SIDED|95.0|0.27|1.63|||Regression, Cox|||||1.63|0.27|0.371
70869083|NCT02571777|141223869|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.996|TWO_SIDED|95.0|0.37|2.66|||Regression, Cox|||||2.66|0.37|0.996
70869084|NCT02571777|141223869|SUPERIORITY||Hazard Ratio (HR)|1.89||||0.145|TWO_SIDED|95.0|0.8|4.47|||Regression, Cox|||||4.47|0.80|0.145
70869085|NCT02571777|141223869|SUPERIORITY||Hazard Ratio (HR)|1.88||||0.15|TWO_SIDED|95.0|0.8|4.43|||Regression, Cox|||||4.43|0.80|0.150
70869086|NCT02571777|141223870|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.523|TWO_SIDED|95.0|0.77|1.15|||Regression, Cox|||Moderate or severe asthma exacerbation||1.15|0.77|0.523
70869087|NCT02571777|141223870|SUPERIORITY||Hazard Ratio (HR)|0.7|||<|0.001|TWO_SIDED|95.0|0.58|0.84|||Regression, Cox|||Moderate or severe asthma exacerbation||0.84|0.58|<0.001
70869088|NCT02571777|141223870|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.164|TWO_SIDED|95.0|0.72|1.06|||Regression, Cox|||Moderate or severe asthma exacerbation||1.06|0.72|0.164
70952025|NCT00895895|141405323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.424|TWO_SIDED|95.0|-1.0|2.3|||Mixed Models Analysis|Mixed Model with repeated measures: change=Mini Mental State Examination (MMSE) Japan baseline baseline times(\*)visit visit treatment treatment\*visit.||Analysis of adjusted difference in change from baseline.||2.3|-1.0|0.424
70869089|NCT02571777|141223870|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.005|TWO_SIDED|95.0|0.63|0.92|||Regression, Cox|||Moderate or severe asthma exacerbation||0.92|0.63|0.005
70869090|NCT02571777|141223870|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.476|TWO_SIDED|95.0|0.72|1.16|||Regression, Cox|||Severe asthma exacerbation||1.16|0.72|0.476
70869091|NCT02571777|141223870|SUPERIORITY||Hazard Ratio (HR)|0.68|||<|0.001|TWO_SIDED|95.0|0.54|0.85|||Regression, Cox|||Severe asthma exacerbation||0.85|0.54|<0.001
70869092|NCT02571777|141223870|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.243|TWO_SIDED|95.0|0.7|1.09|||Regression, Cox|||Severe asthma exacerbation||1.09|0.70|0.243
70869093|NCT02571777|141223870|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.027|TWO_SIDED|95.0|0.63|0.97|||Regression, Cox|||Severe asthma exacerbation||0.97|0.63|0.027
70869094|NCT02571777|141223870|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.497|TWO_SIDED|95.0|0.79|1.12|||Regression, Cox|||All (mild, moderate, severe) asthma exacerbation||1.12|0.79|0.497
70869095|NCT02571777|141223870|SUPERIORITY||Hazard Ratio (HR)|0.71|||<|0.001|TWO_SIDED|95.0|0.6|0.84|||Regression, Cox|||All (mild, moderate, severe) asthma exacerbation||0.84|0.60|<0.001
70869096|NCT02571777|141223870|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.126|TWO_SIDED|95.0|0.73|1.04|||Regression, Cox|||All (mild, moderate, severe) asthma exacerbation||1.04|0.73|0.126
70869097|NCT02571777|141223870|SUPERIORITY||Hazard Ratio (HR)|0.72|||<|0.001|TWO_SIDED|95.0|0.61|0.85|||Regression, Cox|||All (mild, moderate, severe) asthma exacerbation||0.85|0.61|<0.001
70869098|NCT02571777|141223871|SUPERIORITY||Rate ratio|0.85||||0.12|TWO_SIDED|95.0|0.68|1.04|||Generalized linear model|||Moderate or severe asthma exacerbation||1.04|0.68|0.120
70869099|NCT02571777|141223871|SUPERIORITY||Rate ratio|0.64|||<|0.001|TWO_SIDED|95.0|0.52|0.78|||Generalized linear model|||Moderate or severe asthma exacerbation||0.78|0.52|<0.001
70869100|NCT02571777|141223871|SUPERIORITY||Rate ratio|0.87||||0.17|TWO_SIDED|95.0|0.71|1.06|||Generalized linear modeñ|||Moderate or severe asthma exacerbation||1.06|0.71|0.170
70869101|NCT02571777|141223871|SUPERIORITY||Rate ratio|0.81||||0.041|TWO_SIDED|95.0|0.66|0.99|||Generalized linear model|||Moderate or severe asthma exacerbation||0.99|0.66|0.041
70869102|NCT02571777|141223871|SUPERIORITY||Rate ratio|0.78||||0.05|TWO_SIDED|95.0|0.61|1.0|||Generalized linear model|||Severe asthma exacerbation||1.00|0.61|0.050
70869103|NCT02571777|141223871|SUPERIORITY||Rate ratio|0.58|||<|0.001|TWO_SIDED|95.0|0.45|0.73|||Generalized linear model|||Severe asthma exacerbation||0.73|0.45|<0.001
70869104|NCT02571777|141223871|SUPERIORITY||Rate ratio|0.93||||0.531|TWO_SIDED|95.0|0.74|1.17|||Generalized linear model|||Severe asthma exacerbation||1.17|0.74|0.531
70869105|NCT02571777|141223871|SUPERIORITY||Rate ratio|0.84||||0.117|TWO_SIDED|95.0|0.67|1.05|||Linear generalized model|||Severe asthma exacerbation||1.05|0.67|0.117
70869106|NCT02571777|141223871|SUPERIORITY||Rate ratio|0.79||||0.016|TWO_SIDED|95.0|0.66|0.96|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||0.96|0.66|0.016
70869107|NCT02571777|141223871|SUPERIORITY||Rate ratio|0.6|||<|0.001|TWO_SIDED|95.0|0.5|0.72|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||0.72|0.50|<0.001
70869108|NCT02571777|141223871|SUPERIORITY||Rate ratio|0.87||||0.161|TWO_SIDED|95.0|0.72|1.06|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||1.06|0.72|0.161
70869109|NCT02571777|141223871|SUPERIORITY||Rate ratio|0.7|||<|0.001|TWO_SIDED|95.0|0.58|0.84|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||0.84|0.58|<0.001
70869110|NCT02571777|141223872|SUPERIORITY|||||||0.183|||||||van Elteren test|||Moderate or severe asthma exacerbation||||0.183
70869111|NCT02571777|141223872|SUPERIORITY||||||<|0.001|||||||van Elteren test|||Moderate or severe asthma exacerbation||||<0.001
70869112|NCT02571777|141223872|SUPERIORITY|||||||0.155|||||||van Elteren test|||Moderate or severe asthma exacerbation||||0.155
70869113|NCT02571777|141223872|SUPERIORITY|||||||0.007|||||||van Elteren test|||Moderate or severe asthma exacerbation||||0.007
70869114|NCT02571777|141223872|SUPERIORITY|||||||0.172|||||||van Elteren test|||Severe asthma exacerbation||||0.172
70869115|NCT02571777|141223872|SUPERIORITY||||||<|0.001|||||||van Elteren test|||Severe asthma exacerbation||||<0.001
70869116|NCT02571777|141223872|SUPERIORITY|||||||0.241|||||||van Elteren test|||Severe asthma exacerbation||||0.241
70869117|NCT02571777|141223872|SUPERIORITY|||||||0.033|||||||van Elteren test|||Severe asthma exacerbation||||0.033
70869118|NCT02571777|141223872|SUPERIORITY|||||||0.095|||||||van Elteren test|||All (mild, moderate, severe) asthma exacerbation||||0.095
70869119|NCT02571777|141223872|SUPERIORITY||||||<|0.001|||||||van Elteren test|||All (mild, moderate, severe) asthma exacerbation||||<0.001
70952026|NCT00895895|141405323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.849|TWO_SIDED|95.0|-1.8|1.5|||Mixed Models Analysis|Mixed Model with repeated measures: change equals (=) MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.5|-1.8|0.849
70869120|NCT02571777|141223872|SUPERIORITY|||||||0.09|||||||van Elteren test|||All (mild, moderate, severe) asthma exacerbation||||0.090
70869121|NCT02571777|141223872|SUPERIORITY||||||<|0.001|||||||van Elteren test|||All (mild, moderate, severe) asthma exacerbation||||<0.001
70869122|NCT02571777|141223874|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.314|TWO_SIDED|95.0|0.12|1.96|||Regression, Cox|||||1.96|0.12|0.314
70869123|NCT02571777|141223874|SUPERIORITY||Hazard Ratio (HR)|0.28||||0.055|TWO_SIDED|95.0|0.08|1.03|||Regression, Cox|||||1.03|0.08|0.055
70869124|NCT02571777|141223874|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.306|TWO_SIDED|95.0|0.25|1.54|||Regression, Cox|||||1.54|0.25|0.306
70869125|NCT02571777|141223874|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.566|TWO_SIDED|95.0|0.3|1.94|||Regression, Cox|||||1.94|0.30|0.566
70869126|NCT02571777|141223876|SUPERIORITY||LS Mean|-0.8|STANDARD_ERROR_OF_MEAN|1.74||0.645|TWO_SIDED|95.0|-4.2|2.6|||LMM|||Week 26||2.6|-4.2|0.645
71143846|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.899||||0.0002|TWO_SIDED|95.0|1.866|5.933|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.933|1.866|0.0002
71143847|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.922||||0.0002|TWO_SIDED|95.0|1.826|6.018|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.018|1.826|0.0002
71143848|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.962||||0.0004|TWO_SIDED|95.0|1.753|6.172|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.172|1.753|0.0004
71143849|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.985||||0.0006||95.0|1.712|6.258|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.258|1.712|0.0006
71143850|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.026||||0.001|TWO_SIDED|95.0|1.638|6.413|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.413|1.638|0.0010
71143851|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.048||||0.0012|TWO_SIDED|95.0|1.597|6.5|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.500|1.597|0.0012
71143852|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.089||||0.0018|TWO_SIDED|95.0|1.521|6.656|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.656|1.521|0.0018
71143853|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.111||||0.0022|TWO_SIDED|95.0|1.479|6.743|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.743|1.479|0.0022
71143854|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.152||||0.0031|TWO_SIDED|95.0|1.403|6.901|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.901|1.403|0.0031
71143855|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.174||||0.0037||95.0|1.36|6.988|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.988|1.360|0.0037
71143856|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.215||||0.0048|TWO_SIDED|95.0|1.283|7.147|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.147|1.283|0.0048
71143857|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.237||||0.0056|TWO_SIDED|95.0|1.24|7.235|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.235|1.240|0.0056
71143858|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.278||||0.0071|TWO_SIDED|95.0|1.162|7.394|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.394|1.162|0.0071
70869127|NCT02571777|141223876|SUPERIORITY||LS Mean|2.9|STANDARD_ERROR_OF_MEAN|1.73||0.095|TWO_SIDED|95.0|-0.5|6.3|||LMM|||Week 26||6.3|-0.5|0.095
70869128|NCT02571777|141223876|SUPERIORITY||LMM|1.3|STANDARD_ERROR_OF_MEAN|1.75||0.46|TWO_SIDED|95.0|-2.1|4.7|||LMM|||Week 26||4.7|-2.1|0.460
70869129|NCT02571777|141223876|SUPERIORITY||LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|1.75||0.971|TWO_SIDED|95.0|-3.5|3.4|||LMM|||Week 26||3.4|-3.5|0.971
70952027|NCT00895895|141405323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.52|TWO_SIDED|95.0|-2.2|1.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.1|-2.2|0.520
70869130|NCT02571777|141223876|SUPERIORITY||LMM|0.1|STANDARD_ERROR_OF_MEAN|1.78||0.963|TWO_SIDED|95.0|-3.4|3.6|||LMM|||Week 52||3.6|-3.4|0.963
70869131|NCT02571777|141223876|SUPERIORITY||LS Mean|3.2|STANDARD_ERROR_OF_MEAN|1.77||0.075|TWO_SIDED|95.0|-0.3|6.6|||LMM|||Week 52||6.6|-0.3|0.075
70869132|NCT02571777|141223876|SUPERIORITY||LS Mean|1.2|STANDARD_ERROR_OF_MEAN|1.79||0.517|TWO_SIDED|95.0|-2.3|4.7|||LMM|||Week 52||4.7|-2.3|0.517
70869133|NCT02571777|141223876|SUPERIORITY||LS Mean|0.1|STANDARD_ERROR_OF_MEAN|1.78||0.956|TWO_SIDED|95.0|-3.4|3.6|||LMM|||Week 52||3.6|-3.4|0.956
70869134|NCT02571777|141223877|SUPERIORITY||LS Mean|0.02|STANDARD_ERROR_OF_MEAN|0.0502||0.69|TWO_SIDED|95.0|-0.078|0.118|||MMRM|||||0.118|-0.078|0.690
70869135|NCT02571777|141223877|SUPERIORITY||LS Mean|0.06|STANDARD_ERROR_OF_MEAN|0.0502||0.232|TWO_SIDED|95.0|-0.038|0.159|||MMRM|||||0.159|-0.038|0.232
70869136|NCT02571777|141223877|SUPERIORITY||LS Mean|-0.054|STANDARD_ERROR_OF_MEAN|0.0506||0.285|TWO_SIDED|95.0|-0.153|0.045|||MMRM|||||0.045|-0.153|0.285
70869137|NCT02571777|141223877|SUPERIORITY||LS Mean|-0.05|STANDARD_ERROR_OF_MEAN|0.0505||0.319|TWO_SIDED|95.0|-0.15|0.049|||MMRM|||||0.049|-0.150|0.319
70869138|NCT02571777|141223878|SUPERIORITY||LS Mean|0.068|STANDARD_ERROR_OF_MEAN|0.0166|<|0.001|TWO_SIDED|95.0|0.036|0.101|||MMRM|||Week 4||0.101|0.036|<0.001
70869139|NCT02571777|141223878|SUPERIORITY||LS Mean|0.145|STANDARD_ERROR_OF_MEAN|0.0165|<|0.001|TWO_SIDED|95.0|0.113|0.177|||MMRM|||Week 4||0.177|0.113|<0.001
70869140|NCT02571777|141223878|SUPERIORITY||LS Mean|0.033|STANDARD_ERROR_OF_MEAN|0.0167||0.049|TWO_SIDED|95.0|0.0|0.066|||MMRM|||Week 4||0.066|0.000|0.049
70869141|NCT02571777|141223878|SUPERIORITY||LS Mean|0.096|STANDARD_ERROR_OF_MEAN|0.0166|<|0.001|TWO_SIDED|95.0|0.064|0.129|||MMRM|||Week 4||0.129|0.064|<0.001
70869142|NCT02571777|141223878|SUPERIORITY||LS Mean|0.058|STANDARD_ERROR_OF_MEAN|0.0184||0.002|TWO_SIDED|95.0|0.022|0.094|||MMRM|||Week 12||0.094|0.022|0.002
70869143|NCT02571777|141223878|SUPERIORITY||LS Mean|0.117|STANDARD_ERROR_OF_MEAN|0.0183|<|0.001|TWO_SIDED|95.0|0.081|0.153|||MMRM|||Week 12||0.153|0.081|<0.001
70869144|NCT02571777|141223878|SUPERIORITY||LS Mean|0.05|STANDARD_ERROR_OF_MEAN|0.0185||0.007|TWO_SIDED|95.0|0.013|0.086|||MMRM|||Week 12||0.086|0.013|0.007
70869145|NCT02571777|141223878|SUPERIORITY||MMRM|0.087|STANDARD_ERROR_OF_MEAN|0.0184|<|0.001|TWO_SIDED|95.0|0.051|0.123|||MMRM|||Week 12||0.123|0.051|<0.001
70869146|NCT00801632|141223880|SUPERIORITY_OR_OTHER||Percentage of Participants|60.0|||||TWO_SIDED|95.0|14.7|94.7|||||Clopper-Pearson used to derive confidence interval|||94.7|14.7|
70869147|NCT00801632|141223882|SUPERIORITY_OR_OTHER|||||||0.215|TWO_SIDED|||||P-value based on a paired t-test comparing baseline creatinine level with the level at study completion/participant termination.|t-test, 2 sided|The test describes whether the average of the difference is different from zero.||||||0.215
70952028|NCT00895895|141405323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.258|TWO_SIDED|95.0|-2.6|0.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.7|-2.6|0.258
70869148|NCT01350492|141223892|SUPERIORITY||Wilks' Lambda|0.939||||0.68|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Multivariate regression|A Generalized Linear Model was employed with repeated measurements of pain ratings as the multivariate dependent variables and group as covariate.||General multivariate regression models were used to estimate the time averaged difference in pain ratings and other symptom scores (continuous measurements) between the treatment and the control group. In order to achieve 90% power, at alpha equal to .05, with an effect size of .6 (minimum effect size of clinical importance) and with a correlation of .6 between measurements from each individual, we estimated the necessary sample size at 34 subjects per group.||||0.680
70869149|NCT01350492|141223893|SUPERIORITY||Wilks' Lambda|0.96||||0.854|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mulitvariate regression|A Generalized Linear Model was employed with repeated measurements of pain ratings as the multivariate dependent variables and group as covariate.||General multivariate regression models were used to estimate the time averaged difference in pain ratings and other symptom scores (continuous measurements) between the treatment and the control group. In order to achieve 90% power, at alpha equal to .05, with an effect size of .6 (minimum effect size of clinical importance) and with a correlation of .6 between measurements from each individual, we estimated the necessary sample size at 34 subjects per group.||||0.854
70869150|NCT01350492|141223894|SUPERIORITY|||||||0.0002||||||The threshold for statistical significance was p = 0.05.|Multivariate regression|A Generalized Linear Model was employed with repeated measurements of pain ratings as the multivariate dependent variables and group as covariate.||General multivariate regression models were used to estimate the time averaged difference in pain ratings and other symptom scores (continuous measurements) between the treatment and the control group. In order to achieve 90% power, at alpha equal to .05, with an effect size of .6 (minimum effect size of clinical importance) and with a correlation of .6 between measurements from each individual, we estimated the necessary sample size at 34 subjects per group.||||0.0002
70869151|NCT01350492|141223895|SUPERIORITY||Wilks' Lambda|0.857||||0.41|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Multivariate regression|A Generalized Linear Model was employed with repeated measurements of pain ratings as the multivariate dependent variables and group as covariate.||General multivariate regression models were used to estimate the time averaged difference in pain ratings and other symptom scores (continuous measurements) between the treatment and the control group. In order to achieve 90% power, at alpha equal to .05, with an effect size of .6 (minimum effect size of clinical importance) and with a correlation of .6 between measurements from each individual, we estimated the necessary sample size at 34 subjects per group.||||0.41
70952029|NCT00895895|141405324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.367|TWO_SIDED|95.0|-5.2|1.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.9|-5.2|0.367
70952030|NCT00895895|141405324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.91|TWO_SIDED|95.0|-3.3|3.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||3.7|-3.3|0.910
70952031|NCT00895895|141405324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.16|TWO_SIDED|95.0|-1.0|6.0|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||6.0|-1.0|0.160
70869152|NCT01350492|141223896|SUPERIORITY||Wilks' Lambda|0.828||||0.16|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Multivariate regression|A Generalized Linear Model was employed with repeated measurements of pain ratings as the multivariate dependent variables and group as covariate.||General multivariate regression models were used to estimate the time averaged difference in pain ratings and other symptom scores (continuous measurements) between the treatment and the control group. In order to achieve 90% power, at alpha equal to .05, with an effect size of .6 (minimum effect size of clinical importance) and with a correlation of .6 between measurements from each individual, we estimated the necessary sample size at 34 subjects per group.||||0.16
70869153|NCT01350492|141223897|SUPERIORITY||Wilks' Lambda|0.919||||0.66|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Multivariate regression|A Generalized Linear Model was employed with repeated measurements of pain ratings as the multivariate dependent variables and group as covariate.||General multivariate regression models were used to estimate the time averaged difference in pain ratings and other symptom scores (continuous measurements) between the treatment and the control group. In order to achieve 90% power, at alpha equal to .05, with an effect size of .6 (minimum effect size of clinical importance) and with a correlation of .6 between measurements from each individual, we estimated the necessary sample size at 34 subjects per group.||||0.66
70869154|NCT01146834|141223907|SUPERIORITY||Risk Difference (RD)|-0.02||||0.9|TWO_SIDED|95.0|-0.32|0.28|||Chi-squared|||Arm B was initially closed due to low accrual, and Arms D and E were also closed due to no accrual. Arms A and C also had very low accrual. Therefore, the comparison of the primary outcome between Arms A and C is for exploratory purposes only.||0.28|-0.32|0.90
70869155|NCT01146834|141223909|SUPERIORITY||Risk Difference (RD)|-0.25||||0.25|TWO_SIDED|95.0|-0.68|0.18|||Fisher Exact|||||0.18|-0.68|0.25
70869156|NCT00282984|141223917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.05|||<|0.0001||95.0|4.13|8.86||To preserve type I family-wise error rate of 0.05, used step-down procedure to analyze primary \& 2 key secondary endpoints. Hierarchy of comparisons: 1) 4-week CQR for Weeks 9 thru 12, 2) CA at Week 52, 3) the Long Term Quit Rate (LTQR) thru Week 52.|Regression, Logistic|Logistic regression model fitted to primary endpoint \& key secondary endpoints; included main effects of trtmt group and center as independent var.||Estimates for expected \& clinically meaningful var \& pbo 4-week CQR for Week 9 - 12 of trtmt based on response rates \& corresponding 95% OR confidence interval (CI) from A30510285 \& A30510366 study results. Total n=700 randomized var or pbo 1:1 should have provided at least 99% power to detect difference in primary endpoint (endpt) between (b/w) var \& pbo, assuming true 4-week CQR of 0.18 for pbo \& 0.40 for var (OR of at least 3.04), and 84% power for 2 key secondary endpts.||8.86|4.13|<0.0001
70869157|NCT00282984|141223918|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.19|||<|0.0001||95.0|1.97|5.18||To preserve type I family-wise error rate of 0.05, a step-down procedure was used for the analysis of primary \& 2 key secondary endpts. Hierarchy of comparisons: 1) 4-week CQR for Weeks 9 through 12, 2) CA at Week 52, 3) LTQR through Week 52.|Regression, Logistic|Logistic regression model fitted to primary endpoint \& key secondary endpoints; included main effects of treatment group \& center as independent var.||Estimates for expected and clinically meaningful var \& pbo 4-week CQR for Weeks 9 - 12 of trtmt were based on response rates \& corresponding 95% odds ratio CI from A30510285 and A30510366 study results. Total n=700 randomized var or pbo 1:1 should have provided at least 99% power to detect difference in primary endpt b/w var \& pbo, assuming true 4-week CQR of 0.18 for pbo \& 0.40 for var (odds ratio of at least 3.04) \& a power of 84% for the 2 key secondary endpts.||5.18|1.97|<0.0001
70952032|NCT00895895|141405324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4||||0.06|TWO_SIDED|95.0|-0.1|6.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||6.9|-0.1|0.060
70952033|NCT00895895|141405325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.931|TWO_SIDED|95.0|-2.8|3.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||3.1|-2.8|0.931
70952034|NCT00895895|141405325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9||||0.054|TWO_SIDED|95.0|-5.8|0.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.1|-5.8|0.054
70952035|NCT00895895|141405325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.246|TWO_SIDED|95.0|-4.6|1.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.2|-4.6|0.246
70952036|NCT00895895|141405325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.426|TWO_SIDED|95.0|-4.1|1.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.7|-4.1|0.426
71143859|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3||||0.0081|TWO_SIDED|95.0|1.119|7.482|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.482|1.119|0.0081
71143860|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.341||||0.0099|TWO_SIDED|95.0|1.041|7.642|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.642|1.041|0.0099
71143861|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.364||||0.0111|TWO_SIDED|95.0|0.997|7.73|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.730|0.997|0.0111
71143862|NCT00083889|141781650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.404||||0.0133|TWO_SIDED|95.0|0.918|7.89|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.890|0.918|0.0133
71143863|NCT00083889|141781651|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5404|||<|0.0001|TWO_SIDED|95.0|0.4532|0.6444||p-value is from 2-sided, unstratified test.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248: a hazard ratio greater than 1 indicates a reduction in favor of IFN-a.|Unstratified analysis: Hazard Ratio (SU011248 vs IFN-α).||0.6444|0.4532|<0.0001
71143864|NCT00083889|141781651|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5418|||<|1e-05|TWO_SIDED|95.0|0.4536|0.6473||p-value is from 2-sided, stratified test. Stratification factors are: Lactic Dehydrogenase (LDH) \> or \<= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248: a hazard ratio greater than 1 indicates a reduction in favor of IFN-a.|Stratified analysis: Hazard Ratio (SU011248 vs IFN-α).||0.6473|0.4536|<.00001
71143865|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.486|||<|0.0001|TWO_SIDED|95.0|3.852|7.119|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) baseline score (intercept and time since randomization are included as random effects).||7.119|3.852|<.0001
71143866|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.535|||<|0.0001|TWO_SIDED|95.0|3.955|7.115|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.115|3.955|<.0001
71143867|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.562|||<|0.0001|TWO_SIDED|95.0|4.0|7.124|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.124|4.000|<.0001
71143868|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.611|||<|0.0001|TWO_SIDED|95.0|4.061|7.162|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.162|4.061|<.0001
71143869|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.639|||<|0.0001|TWO_SIDED|95.0|4.083|7.195|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.195|4.083|<.0001
71143870|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.688|||<|0.0001|TWO_SIDED|95.0|4.1|7.276|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.276|4.100|<.0001
71143871|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.715|||<|0.0001|TWO_SIDED|95.0|4.098|7.333|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.333|4.098|<.0001
70869158|NCT00282984|141223919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.82|||<|0.0001||95.0|1.82|4.38||To preserve type I family-wise error rate of 0.05, a step-down procedure was used for the analysis of primary \& 2 key secondary endpoints. Hierarchy of comparisons: 1) 4-week CQR for Weeks 9 through 12, 2) CA at Week 52, 3) the LTQR through Week 52.|Regression, Logistic|Logistic regression model fitted to primary endpoint \& key secondary endpoints; included main effects of trtmt group and center as independent var.||Estimates for expected and clinically meaningful varenicline (var) \& pbo 4-week CQR for Weeks 9 - 12 of treatment were based on response rates \& corresponding 95% odds ratio CI from A30510285 and A30510366 study results. Total n=700 randomized var or pbo 1:1 should have provided at least 99% power to detect difference in primary endpt b/w varenicline \& pbo, assuming true 4-week CQR of 0.18 for pbo \& 0.40 for var (odds ratio of at least 3.04), and a power of 84% for the 2 key secondary endpts.||4.38|1.82|<0.0001
70869159|NCT00282984|141223920|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.97|||<|0.0001||95.0|4.17|8.56|||Regression, Logistic|||Week 12 analysis||8.56|4.17|<0.0001
70869160|NCT00282984|141223921|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.93|||<|0.0001||95.0|2.03|4.23|||Regression, Logistic|||24 Week analysis||4.23|2.03|<0.0001
70869161|NCT00282984|141223922|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93||||0.0003||95.0|1.34|2.77|||Regression, Logistic|||52 Week analysis||2.77|1.34|0.0003
70869162|NCT00282984|141223923|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05||||0.0001||95.0|1.41|2.97|||Regression, Logistic|||||2.97|1.41|0.0001
70869163|NCT00282984|141223924|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.86|||<|0.0001||95.0|2.51|5.93|||Regression, Logistic|||||5.93|2.51|<0.0001
70869164|NCT00282984|141223926|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.85|||<|0.0001||95.0|2.58|5.75|||Regression, Logistic|||||5.75|2.58|<0.0001
70869165|NCT02015754|141223958|OTHER|||||||0.004||||||Differences of p-value \< 0.05 considered statistically significant.|Regression, Cox|||Multivariate Cox-regression analysis to identify independent prognostic factors for overall survival from baseline characteristics. Relative risk with 95% confidence intervals calculated as measure of association.||||0.004
70952037|NCT00895895|141405326|SUPERIORITY_OR_OTHER|||||||0.265|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.265
70869166|NCT02015754|141223965|OTHER|VEGF immediately post treatment||||||0.6257|||||||one-sample Wilcoxon signed rank test|||||||0.6257
70869167|NCT02015754|141223965|OTHER|VEGF at 24 hours post treatment.||||||0.4143|||||||one-sample Wilcoxon signed rank test|||||||0.4143
70869168|NCT02015754|141223965|OTHER|VEGFR1 immediately post treatment.||||||0.583|||||||one-sample Wilcoxon signed rank test|||||||0.583
70869169|NCT02015754|141223965|OTHER|VEGFR1 at 24 hours post treatment.||||||0.0012|||||||one-sample Wilcoxon signed rank test|||||||.0012
70869170|NCT02015754|141223965|OTHER|VEGFR2 immediately post treatment.||||||0.1353|||||||one-sample Wilcoxon signed rank test|||||||0.1353
70952038|NCT00895895|141405326|SUPERIORITY_OR_OTHER|||||||0.682|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.682
70869171|NCT02015754|141223965|OTHER|VEGFR2 at 24 hours post treatment.||||||0.2163|||||||one-sample Wilcoxon signed rank test|||||||0.2163
70869172|NCT00668707|141224006|SUPERIORITY||Risk Ratio (RR)|1.01||||0.94|TWO_SIDED|95.0|0.83|1.22|||Regression, Logistic|||Analysis conducted was an adjusted logistic regression (adjuvant chemotherapy, adjuvant radiation, smoking history). Results were presented as a relative risk. Based on an estimated 30% outcome rate of recurrence or mortality in the control arm, 294 participants per arm provided 80% power to detect a relative risk of one third at an alpha of 0.05. We inflated this sample size to 346 per arm to account for 15% lost to follow-up.||1.22|0.83|0.94
70869173|NCT00668707|141224007|SUPERIORITY||Mean Difference (Net)|1.2||||0.36|TWO_SIDED|95.0|-1.3|3.7|||Mixed Models Analysis|Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.||Analysis for the LC-13 scale.||3.7|-1.3|0.36
70869174|NCT00668707|141224007|SUPERIORITY||Mean Difference (Net)|0.4||||0.8|TWO_SIDED|95.0|-2.5|3.3||Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.|Mixed Models Analysis|||Analysis for Symptom Scale.||3.3|-2.5|0.80
70869175|NCT00668707|141224007|SUPERIORITY||Mean Difference (Net)|-0.7||||0.69|TWO_SIDED|95.0|-4.1|2.7||Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.|Mixed Models Analysis|||Analysis for Functional Scale.||2.7|-4.1|0.69
70869176|NCT00668707|141224007|SUPERIORITY||Mean Difference (Net)|-3.8||||0.11|TWO_SIDED|95.0|-8.5|0.9||Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.|Mixed Models Analysis|||Analysis for Global Scale.||0.9|-8.5|0.11
70869177|NCT00668707|141224008|SUPERIORITY||Mean Difference (Net)|-3.1||||0.13|TWO_SIDED|95.0|-7.2|0.9|||Mixed Models Analysis|||Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.||0.9|-7.2|0.13
70869178|NCT00668707|141224009|SUPERIORITY||Mean Difference (Net)|-4.1||||0.18|TWO_SIDED|95.0|-10.0|1.9|||Mixed Models Analysis|Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.||Sleep Adequacy Analysis.||1.9|-10.0|0.18
70869179|NCT00668707|141224009|SUPERIORITY||Mean Difference (Net)|1.4||||0.41|TWO_SIDED|95.0|-2.0|4.8|||Mixed Models Analysis|Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.||Sleep problems index II analysis.||4.8|-2.0|0.41
70869180|NCT00668707|141224013|SUPERIORITY|||||||0.62|||||||Chi-squared|||||||0.62
70869181|NCT00668707|141224014|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.41|TWO_SIDED|95.0|0.85|1.07|||Log Rank|||DFS up to five years post-surgery was compared using Kaplan-Meier curves and the log rank test, followed by a hazard ratio calculated using the Cox proportional hazard model adjusting for adjuvant chemotherapy, adjuvant radiation, and smoking history.||1.07|0.85|0.41
70952039|NCT00895895|141405326|SUPERIORITY_OR_OTHER|||||||0.532|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.532
70952040|NCT00895895|141405326|SUPERIORITY_OR_OTHER|||||||0.087|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.087
70952041|NCT00895895|141405326|SUPERIORITY_OR_OTHER|||||||0.751|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.751
70952042|NCT00895895|141405327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.553|TWO_SIDED|95.0|-3.9|7.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||7.3|-3.9|0.553
70952043|NCT00895895|141405327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.886|TWO_SIDED|95.0|-6.0|5.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||5.2|-6.0|0.886
70869182|NCT00668707|141224014|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.66|TWO_SIDED|95.0|0.85|1.11|||Log Rank|||This analysis included only those with stage I or II cancer (pathologic stage). DFS up to five years post-surgery was compared using Kaplan-Meier curves and the log rank test, followed by a hazard ratio calculated using the Cox proportional hazard model adjusting for adjuvant chemotherapy, adjuvant radiation, and smoking history.||1.11|0.85|0.66
71143872|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.764|||<|0.0001|TWO_SIDED|95.0|4.075|7.454|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.454|4.075|<.0001
71143873|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.792|||<|0.0001|TWO_SIDED|95.0|4.053|7.531|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.531|4.053|<.0001
71143874|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.841|||<|0.0001|TWO_SIDED|95.0|3.998|7.684|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.684|3.998|<.0001
71143875|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.868|||<|0.0001|TWO_SIDED|95.0|3.96|7.777|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.777|3.960|<.0001
71143876|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.917|||<|0.0001|TWO_SIDED|95.0|3.88|7.955|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.955|3.880|<.0001
71143877|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.945|||<|0.0001|TWO_SIDED|95.0|3.83|8.06|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||8.060|3.830|<.0001
71143878|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.994|||<|0.0001|TWO_SIDED|95.0|3.731|8.257|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||8.257|3.731|<.0001
71143879|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.021|||<|0.0001|TWO_SIDED|95.0|3.672|8.37|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||8.370|3.672|<.0001
71143880|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.071|||<|0.0001|TWO_SIDED|95.0|3.56|8.581|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||8.581|3.560|<.0001
71143881|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.098|||<|0.0001|TWO_SIDED|95.0|3.495|8.701|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||8.701|3.495|<.0001
71143882|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.147|||<|0.0001|TWO_SIDED|95.0|3.373|8.921|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||8.921|3.373|<.0001
71143883|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.174|||<|0.0001|TWO_SIDED|95.0|3.303|9.045|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||9.045|3.303|<.0001
71143884|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.224|||<|0.0001|TWO_SIDED|95.0|3.174|9.273|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||9.273|3.174|<.0001
71143885|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.251||||0.0001|TWO_SIDED|95.0|3.101|9.401|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||9.401|3.101|0.0001
70952044|NCT00895895|141405327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.712|TWO_SIDED|95.0|-6.6|4.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||4.5|-6.6|0.712
70952045|NCT00895895|141405327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.785|TWO_SIDED|95.0|-4.8|6.4|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||6.4|-4.8|0.785
70952046|NCT00895895|141405328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.251|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.1|-0.5|0.251
70952047|NCT00895895|141405328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.993|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.3|-0.3|0.993
70952048|NCT00895895|141405328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.553|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.2|-0.4|0.553
70869183|NCT00668707|141224014|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.004|TWO_SIDED|95.0|0.61|0.92|||Log Rank|||This analysis included only those participants who had stage III or IV cancer (pathologic stage). DFS up to five years post-surgery was compared using Kaplan-Meier curves and the log rank test, followed by a hazard ratio calculated using the Cox proportional hazard model adjusting for adjuvant chemotherapy, adjuvant radiation, and smoking history.||0.92|0.61|0.004
70869184|NCT00668707|141224015|SUPERIORITY||Mean Difference (Final Values)|-0.67||||0.95|TWO_SIDED|95.0|-3.21|4.56|||Wilcoxon (Mann-Whitney)|||Analysis of melatonin changes||4.56|-3.21|0.95
70869185|NCT00668707|141224015|SUPERIORITY||Mean Difference (Final Values)|3.63||||0.02|TWO_SIDED|95.0|-0.15|7.42|||Wilcoxon (Mann-Whitney)|||Analysis of placebo changes||7.42|-0.15|0.02
70869186|NCT00668707|141224016|SUPERIORITY|||||||0.37|||||||Chi-squared|||||||0.37
70869187|NCT00668707|141224017|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||This analysis compares the mean ratios of 6 month cytotoxicity and baseline cytotoxicity between arms.||||0.34
70869188|NCT03338010|141224034|NON_INFERIORITY|0.40% noninferiority margin was used.|LS Mean Difference|-0.05||||0.545|TWO_SIDED|95.0|-0.19|0.1|||Mixed Models Analysis|||||0.10|-0.19|0.545
70869189|NCT03338010|141224035|NON_INFERIORITY|0.40% noninferiority margin was used.|LS Mean Difference|-0.05||||0.545|TWO_SIDED|95.0|-0.19|0.1|||Mixed Models Analysis|||||0.10|-0.19|0.545
70869190|NCT03338010|141224036|SUPERIORITY||LS Mean Difference|1.0||||0.602|TWO_SIDED|95.0|-2.8|4.8|||Mixed Models Analysis|||Before Morning Meal Glucose||4.8|-2.8|0.602
70869191|NCT03338010|141224036|SUPERIORITY||LS Mean Difference|-3.7||||0.373|TWO_SIDED|95.0|-11.8|4.4|||Mixed Models Analysis|||2 Hours After Morning Meal Glucose||4.4|-11.8|0.373
70869192|NCT03338010|141224036|SUPERIORITY||LS Mean Difference|-3.3||||0.351|TWO_SIDED|95.0|-10.3|3.7|||Mixed Models Analysis|||Before Mid-Day Meal Glucose||3.7|-10.3|0.351
70869193|NCT03338010|141224036|SUPERIORITY||LS Mean Difference|4.9||||0.23|TWO_SIDED|95.0|-3.1|12.8|||Mixed Models Analysis|||2 Hours After Mid-Day Meal Glucose||12.8|-3.1|0.230
70869194|NCT03338010|141224036|SUPERIORITY||LS Mean Difference|0.9||||0.819|TWO_SIDED|95.0|-6.7|8.5|||Mixed Models Analysis|||Before Evening Meal Glucose||8.5|-6.7|0.819
70869195|NCT03338010|141224036|SUPERIORITY||LS Mean Difference|2.3||||0.588|TWO_SIDED|95.0|-6.2|10.9|||Mixed Models Analysis|||2 Hours After Evening Meal Glucose||10.9|-6.2|0.588
70869196|NCT03338010|141224036|SUPERIORITY||LS Mean Difference|1.4||||0.732|TWO_SIDED|95.0|-6.7|9.5|||Mixed Models Analysis|||Bedtime Glucose||9.5|-6.7|0.732
70869197|NCT03338010|141224037|SUPERIORITY|||||||0.846|||||||Fisher Exact|||||||0.846
70869198|NCT03338010|141224038|SUPERIORITY|||||||0.098|||||||Fisher Exact|||||||0.098
70869199|NCT03338010|141224039|SUPERIORITY||LS Mean Difference|0.32||||0.767|TWO_SIDED|95.0|-1.78|2.42|||Mixed Models Analysis|||Morning Pre-meal Standard Deviation||2.42|-1.78|0.767
70869200|NCT03338010|141224039|SUPERIORITY||LS Mean Difference|0.4||||0.781|TWO_SIDED|95.0|-2.5|3.3|||Mixed Models Analysis|||Daily Mean Standard Deviation||3.3|-2.5|0.781
70869201|NCT03338010|141224040|SUPERIORITY||LS Mean Difference|0.2||||0.75|TWO_SIDED|95.0|-1.2|1.7|||Mixed Models Analysis|||||1.7|-1.2|0.750
70869202|NCT03338010|141224041|SUPERIORITY||LS Mean Difference|0.2||||0.75|TWO_SIDED|95.0|-1.2|1.7|||Mixed Models Analysis|||||1.7|-1.2|0.750
70869203|NCT03338010|141224042|SUPERIORITY||LS Mean Difference|-0.1|||<|0.001|TWO_SIDED|95.0|-0.6|0.3|||Mixed Models Analysis|||||0.3|-0.6|<0.001
70869204|NCT03338010|141224043|SUPERIORITY||LS Mean Difference|-0.95||||0.5|TWO_SIDED|95.0|-3.72|1.82|||Mixed Models Analysis|||Inconvenience of Regimen Transformed Score||1.82|-3.72|0.500
70869205|NCT03338010|141224043|SUPERIORITY||LS Mean Difference|-3.99||||0.031|TWO_SIDED|95.0|-7.62|-0.36|||Mixed Models Analysis|||Lifestyle Flexibility Transformed Score||-0.36|-7.62|0.031
70869206|NCT03338010|141224043|SUPERIORITY||LS Mean Difference|-1.79||||0.2|TWO_SIDED|95.0|-4.53|0.95|||Mixed Models Analysis|||Hypoglycemic Control Transformed Score||0.95|-4.53|0.200
70869207|NCT03338010|141224043|SUPERIORITY||LS Mean Difference|-0.02||||0.988|TWO_SIDED|95.0|-2.92|2.88|||Mixed Models Analysis|||Glycemic Control Transformed Score||2.88|-2.92|0.988
70869208|NCT03338010|141224043|SUPERIORITY||LS Mean Difference|-1.45||||0.337|TWO_SIDED|95.0|-4.41|1.51|||Mixed Models Analysis|||Insulin Delivery Device Satisfaction Transformed Score||1.51|-4.41|0.337
70869209|NCT03338010|141224043|SUPERIORITY||LS Mean Difference|-1.67||||0.205|TWO_SIDED|95.0|-4.26|0.92|||Mixed Models Analysis|||ITSQ Overall Total||0.92|-4.26|0.205
70869210|NCT03338010|141224044|SUPERIORITY|||||||0.639|||||||Fisher Exact|||||||0.639
70869211|NCT03338010|141224045|SUPERIORITY||Relative Ratio|1.19||||0.143|TWO_SIDED|95.0|0.74|1.92|||Wilcoxon (Mann-Whitney)|||||1.92|0.74|0.143
70869212|NCT03338010|141224045|SUPERIORITY||Relative Ratio|1.22||||0.945|TWO_SIDED|95.0|0.67|2.23|||Wilcoxon (Mann-Whitney)|||||2.23|0.67|0.945
70869213|NCT01211730|141224046|SUPERIORITY_OR_OTHER|||||||0.709|||||||Chi-squared, Corrected|||||||0.709
70869214|NCT01211730|141224047|SUPERIORITY_OR_OTHER|||||||0.003|||||||Chi-squared, Corrected|||||||0.003
70869215|NCT01211730|141224048|SUPERIORITY_OR_OTHER|||||||0.0046|||||||Chi-squared, Corrected|||||||0.0046
70869216|NCT01211730|141224049|SUPERIORITY_OR_OTHER|||||||0.75|||||||Chi-squared, Corrected|||||||0.75
70869217|NCT01211730|141224050|SUPERIORITY_OR_OTHER|||||||0.56|||||||Chi-squared, Corrected|||||||0.56
70869218|NCT01211730|141224051|SUPERIORITY_OR_OTHER|||||||0.77|||||||Chi-squared, Corrected|||||||0.77
70869219|NCT02465515|141224052|NON_INFERIORITY|Non-inferiority was determined by testing the hypothesis that the observed hazard ratio is significantly different from the null margin of 1.3 (a one-sided p \<0.025 for such a test with result in appropriate direction being equivalent to the upper 95% confidence limit for the hazard ratio being less than 1.3)|Hazard Ratio (HR)|0.78|||<|0.0001|TWO_SIDED|95.0|0.68|0.9||One-sided p-value based on Wald test of hazard ratio (HR) \>=1.3 versus HR \<1.3.|Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate|||0.90|0.68|<0.0001
70869220|NCT02465515|141224052|SUPERIORITY||||||<|0.001||||||Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1|Wald test|||||||<0.001
70869221|NCT02465515|141224053|OTHER||Hazard Ratio (HR)|0.78|||<|0.001|TWO_SIDED|95.0|0.69|0.9||Two-sided p-value based on the Wald statistic.|Wald statistic||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||0.90|0.69|<0.001
70952049|NCT00895895|141405328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.611|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.2|-0.4|0.611
70952050|NCT00895895|141405329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.34|TWO_SIDED|95.0|-1.5|0.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.5|-1.5|0.340
70952051|NCT00895895|141405329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.63|TWO_SIDED|95.0|-0.8|1.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.2|-0.8|0.630
70952052|NCT00895895|141405329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.678|TWO_SIDED|95.0|-0.8|1.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.2|-0.8|0.678
70952053|NCT00895895|141405329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.518|TWO_SIDED|95.0|-1.3|0.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.7|-1.3|0.518
70952054|NCT00895895|141405330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.953|TWO_SIDED|95.0|-0.7|0.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.7|-0.7|0.953
70952055|NCT00895895|141405330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.956|TWO_SIDED|95.0|-0.7|0.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.6|-0.7|0.956
70952056|NCT00895895|141405330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.216|TWO_SIDED|95.0|-1.1|0.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.2|-1.1|0.216
70952057|NCT00895895|141405330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.665|TWO_SIDED|95.0|-0.8|0.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.5|-0.8|0.665
70952058|NCT00895895|141405331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.373|TWO_SIDED|95.0|-0.6|1.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.7|-0.6|0.373
70952059|NCT00895895|141405331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.781|TWO_SIDED|95.0|-1.0|1.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.3|-1.0|0.781
70952060|NCT00895895|141405331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.417|TWO_SIDED|95.0|-0.7|1.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.6|-0.7|0.417
70952061|NCT00895895|141405331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.853|TWO_SIDED|95.0|-1.3|1.0|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.0|-1.3|0.853
70952062|NCT00895895|141405332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.428|TWO_SIDED|95.0|-2.6|1.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.1|-2.6|0.428
70952063|NCT00895895|141405332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.763|TWO_SIDED|95.0|-2.1|1.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.5|-2.1|0.763
70952064|NCT00895895|141405332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.312|TWO_SIDED|95.0|-2.7|0.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.9|-2.7|0.312
70952065|NCT00895895|141405332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.215|TWO_SIDED|95.0|-3.0|0.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.7|-3.0|0.215
70952066|NCT00895895|141405333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.956|TWO_SIDED|95.0|-2.7|2.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||2.5|-2.7|0.956
70952067|NCT00895895|141405333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.988|TWO_SIDED|95.0|-2.6|2.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||2.5|-2.6|0.988
70869222|NCT02465515|141224054|OTHER||Hazard Ratio (HR)|0.93||||0.578|TWO_SIDED|95.0|0.73|1.19||Two-sided p-value based on the Wald statistic|Wald statistic||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate|||1.19|0.73|0.578
70869223|NCT02465515|141224055|OTHER||Hazard Ratio (HR)|0.75||||0.003|TWO_SIDED|95.0|0.61|0.9||Two-sided p-value based on the Wald statistic.|Wald statistic||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||0.90|0.61|0.003
70869224|NCT02465515|141224056|OTHER||Hazard Ratio (HR)|0.86||||0.3|TWO_SIDED|95.0|0.66|1.14||Two-sided p-value based on the Wald statistic.|Wald statistic||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||1.14|0.66|0.300
70869225|NCT02465515|141224057|OTHER||Hazard Ratio (HR)|0.85||||0.113|TWO_SIDED|95.0|0.7|1.04||Two-sided p-value based on the Wald statistic.|Wald statistic||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||1.04|0.70|0.113
70869226|NCT02465515|141224058|SUPERIORITY||Hazard Ratio (HR)|0.42|||<|0.001|TWO_SIDED|95.0|0.33|0.53||Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1.|Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||0.53|0.33|<0.001
70869227|NCT02465515|141224059|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.043|TWO_SIDED|95.0|0.51|0.99||Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1.|Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||0.99|0.51|0.043
70869228|NCT02465515|141224060|OTHER||||||<|0.001||||||P-value based on the covariate-adjusted extended Mantel-Haenszel test. Covariates include Baseline HbA1c (\<8.0% versus \>= 8.0%) and Baseline diabetes therapy (diet and exercise alone versus all other therapies).|Mantel Haenszel|Month 8||||||<0.001
70869229|NCT02465515|141224060|OTHER||||||<|0.001||||||P-value based on the covariate-adjusted extended Mantel-Haenszel test. Covariates include Baseline HbA1c (\<8.0% versus \>= 8.0%) and Baseline diabetes therapy (diet and exercise alone versus all other therapies).|Mantel Haenszel|Month 16||||||<0.001
70952068|NCT00895895|141405333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.89|TWO_SIDED|95.0|-2.7|2.4|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||2.4|-2.7|0.890
70952069|NCT00895895|141405333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.28|TWO_SIDED|95.0|-4.0|1.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.2|-4.0|0.280
70869230|NCT02465515|141224060|OTHER||||||<|0.001||||||P-value based on the covariate-adjusted extended Mantel-Haenszel test. Covariates include Baseline HbA1c (\<8.0% versus \>= 8.0%) and Baseline diabetes therapy (diet and exercise alone versus all other therapies).|Mantel Haenszel|Month 24||||||<0.001
70952070|NCT00895895|141405334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.154|TWO_SIDED|95.0|-1.5|0.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.2|-1.5|0.154
70952071|NCT00895895|141405334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.74|TWO_SIDED|95.0|-1.0|0.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.7|-1.0|0.740
70952072|NCT00895895|141405334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.179|TWO_SIDED|95.0|-1.4|0.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.3|-1.4|0.179
70952073|NCT00895895|141405334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.543|TWO_SIDED|95.0|-0.6|1.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.1|-0.6|0.543
70869231|NCT02465515|141224060|OTHER||||||<|0.001||||||P-value based on the covariate-adjusted extended Mantel-Haenszel test. Covariates include Baseline HbA1c (\<8.0% versus \>= 8.0%) and Baseline diabetes therapy (diet and exercise alone versus all other therapies).|Mantel Haenszel|Final assessment||||||<0.001
70869232|NCT02465515|141224061|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.055|TWO_SIDED|95.0|0.43|1.01||Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1|Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||1.01|0.43|0.055
70869233|NCT02465515|141224062|OTHER||Mean Difference (Net)|-0.63|||<|0.001|TWO_SIDED|95.0|-0.69|-0.58||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline HbA1c+Treatment+Visit+Treatment-by-Visit Interaction+Baseline HbA1c-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8|||-0.58|-0.69|<0.001
70869234|NCT02465515|141224062|OTHER||Mean Difference (Net)|-0.52|||<|0.001|TWO_SIDED|95.0|-0.58|-0.45||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline HbA1c+Treatment+Visit+Treatment-by-Visit Interaction+Baseline HbA1c-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 16|||-0.45|-0.58|<0.001
70869235|NCT02465515|141224063|OTHER||Mean Difference (Net)|-0.66|||<|0.001|TWO_SIDED|95.0|-0.83|-0.49||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline Body Weight+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Body Weight-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8|||-0.49|-0.83|<0.001
70869236|NCT02465515|141224063|OTHER||Mean Difference (Net)|-0.83|||<|0.001|TWO_SIDED|95.0|-1.06|-0.6||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline Body Weight+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Body weight-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 16|||-0.60|-1.06|<0.001
70869237|NCT02465515|141224064|OTHER||Mean Difference (Net)|2.39|||<|0.001|TWO_SIDED|95.0|1.85|2.93||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero.|t-test, 2 sided||Based on MMRM model: Change=Baseline Total Score+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Total Score-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8|||2.93|1.85|<0.001
70869238|NCT02465515|141224064|OTHER||Mean Difference (Net)|2.33|||<|0.001|TWO_SIDED|95.0|1.66|3.01||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline Total Score+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Total Score-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 16|||3.01|1.66|<0.001
70869239|NCT02465515|141224065|OTHER||Mean Difference (Net)|1.47|||<|0.001|TWO_SIDED|95.0|0.87|2.07||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero.|t-test, 2 sided||Based on MMRM model: Change=Baseline Score+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Score-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8.|||2.07|0.87|<0.001
70869240|NCT02465515|141224065|OTHER||Mean Difference (Net)|0.52||||0.192|TWO_SIDED|95.0|-0.26|1.31||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline Score+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Score-by-Visit Interaction. Difference of least squares means (Albiglutide - Placebo) is from MMRM model for Month 16|||1.31|-0.26|0.192
70869241|NCT02465515|141224066|OTHER||Hazard Ratio (HR)|0.95||||0.644|TWO_SIDED|95.0|0.79|1.16||Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1.|Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||1.16|0.79|0.644
70869242|NCT02465515|141224070|OTHER||Mean Difference (Net)|-1.11||||0.003|TWO_SIDED|95.0|-1.84|-0.39||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero.|t-test, 2 sided||Based on MMRM model: Change=Baseline eGFR+Treatment+Visit+Treatment-by-Visit Interaction+Baseline eGFR-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8.|||-0.39|-1.84|0.003
70869243|NCT02465515|141224070|OTHER||Mean Difference (Net)|-0.43||||0.315|TWO_SIDED|95.0|-1.26|0.41||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline eGFR+Treatment+Visit+Treatment-by-Visit Interaction+Baseline eGFR-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 16.|||0.41|-1.26|0.315
70869244|NCT00293033|141224076|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.74|STANDARD_ERROR_OF_MEAN|3.28||0.004|TWO_SIDED|95.0|3.31|16.18|||Mixed Models Analysis|The SPID was analyzed using a mixed model of repeated measures with fixed effects for treatment, pooled site, and a random effect for subjects.|Onsolis minus placebo|||16.18|3.31|0.004
70869245|NCT00293033|141224077|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.33||0.44|TWO_SIDED|95.0|-0.4|0.91|||Wilcoxon (Mann-Whitney)|||||0.91|-0.40|0.440
70869246|NCT00293033|141224078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.94|STANDARD_ERROR_OF_MEAN|0.7||0.179|TWO_SIDED|95.0|-0.44|2.33|||Mixed Models Analysis|||||2.33|-0.44|0.179
70952074|NCT00895895|141405335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-60.4||||0.861|TWO_SIDED|95.0|-739.7|618.8|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||618.8|-739.7|0.861
70952075|NCT00895895|141405335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-926.6||||0.007|TWO_SIDED|95.0|-1596.9|-256.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||-256.3|-1596.9|0.007
70952076|NCT00895895|141405335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|141.3||||0.676|TWO_SIDED|95.0|-522.1|804.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||804.6|-522.1|0.676
70869247|NCT00293033|141224079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.32|STANDARD_ERROR_OF_MEAN|1.16||0.047|TWO_SIDED|95.0|0.04|4.61|||Mixed Models Analysis|||||4.61|0.04|0.047
70869248|NCT00293033|141224080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.68|STANDARD_ERROR_OF_MEAN|5.7|<|0.001|TWO_SIDED|95.0|8.5|30.86|||Mixed Models Analysis|||||30.86|8.50|<0.001
70869249|NCT00293033|141224081|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|31.98|STANDARD_ERROR_OF_MEAN|8.23|<|0.001|TWO_SIDED|95.0|15.85|48.12|||Mixed Models Analysis|||||48.12|15.85|<0.001
70869250|NCT00293033|141224082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.517|||||||Wilcoxon (Mann-Whitney)|||||||0.517
70869251|NCT00293033|141224083|SUPERIORITY_OR_OTHER_LEGACY|||||||0.458|||||||Wilcoxon (Mann-Whitney)|||||||0.458
70869252|NCT00293033|141224084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.223|||||||Wilcoxon (Mann-Whitney)|||||||0.223
70869253|NCT00293033|141224085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||||||0.015
70869254|NCT00293033|141224086|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
70869255|NCT00293033|141224087|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70869256|NCT00293033|141224088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.193|||||||Wilcoxon (Mann-Whitney)|||||||0.193
70869257|NCT00293033|141224089|SUPERIORITY_OR_OTHER_LEGACY|||||||0.113|||||||Wilcoxon (Mann-Whitney)|||||||0.113
70869258|NCT00293033|141224090|SUPERIORITY_OR_OTHER_LEGACY|||||||0.192|||||||Wilcoxon (Mann-Whitney)|||||||0.192
70869259|NCT00293033|141224091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
70869260|NCT00293033|141224092|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
70869261|NCT00293033|141224093|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70869262|NCT00293033|141224094|SUPERIORITY_OR_OTHER_LEGACY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
70869263|NCT00293033|141224095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.278|||||||Wilcoxon (Mann-Whitney)|||||||0.278
70952077|NCT00895895|141405335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|230.6||||0.505|TWO_SIDED|95.0|-449.7|910.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||910.9|-449.7|0.505
71143886|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3||||0.0002|TWO_SIDED|95.0|2.966|9.634|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||9.634|2.966|0.0002
71143887|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.327||||0.0003|TWO_SIDED|95.0|2.89|9.765|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||9.765|2.890|0.0003
71143888|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.377||||0.0006|TWO_SIDED|95.0|2.751|10.002|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||10.002|2.751|0.0006
71143889|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.404||||0.0008|TWO_SIDED|95.0|2.673|10.135|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||10.135|2.673|0.0008
71143890|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.453||||0.0013|TWO_SIDED|95.0|2.53|10.376|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||10.376|2.530|0.0013
71143891|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.48||||0.0016|TWO_SIDED|95.0|2.451|10.51|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||10.510|2.451|0.0016
71143892|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.53||||0.0025|TWO_SIDED|95.0|2.306|10.754|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||10.754|2.306|0.0025
71143893|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.557||||0.003|TWO_SIDED|95.0|2.224|10.889|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||10.889|2.224|0.0030
70952078|NCT00895895|141405336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8||||0.267|TWO_SIDED|95.0|-2.2|7.8|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||7.8|-2.2|0.267
71143894|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.606||||0.0043|TWO_SIDED|95.0|2.077|11.135|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||11.135|2.077|0.0043
71143895|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.634||||0.0051|TWO_SIDED|95.0|1.995|11.272|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||11.272|1.995|0.0051
71143896|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.683||||0.0068|TWO_SIDED|95.0|1.847|11.519|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||11.519|1.847|0.0068
70869264|NCT00293033|141224096|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062|||||||Wilcoxon (Mann-Whitney)|||||||0.062
70952079|NCT00895895|141405336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6||||0.145|TWO_SIDED|95.0|-1.3|8.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||8.6|-1.3|0.145
70869265|NCT00293033|141224097|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
70869266|NCT00293033|141224098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
70952080|NCT00895895|141405336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7||||0.139|TWO_SIDED|95.0|-1.2|8.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||8.6|-1.2|0.139
70952081|NCT00895895|141405336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2||||0.386|TWO_SIDED|95.0|-2.8|7.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||7.2|-2.8|0.386
70952082|NCT00895895|141405337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.032|TWO_SIDED|95.0|-2.3|-0.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||-0.1|-2.3|0.032
70952083|NCT00895895|141405337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.264|TWO_SIDED|95.0|-0.5|1.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.7|-0.5|0.264
70952084|NCT00895895|141405337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.893|TWO_SIDED|95.0|-1.0|1.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.1|-1.0|0.893
70952085|NCT00895895|141405337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.525|TWO_SIDED|95.0|-0.7|1.4|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.4|-0.7|0.525
70952086|NCT00895895|141405338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|60.9||||0.056|TWO_SIDED|95.0|-1.6|123.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||123.5|-1.6|0.056
70952087|NCT00895895|141405338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.8||||0.488|TWO_SIDED|95.0|-40.0|83.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||83.5|-40.0|0.488
70952088|NCT00895895|141405338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6||||0.783|TWO_SIDED|95.0|-52.6|69.8|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||69.8|-52.6|0.783
70952089|NCT00895895|141405338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.6||||0.578|TWO_SIDED|95.0|-44.6|79.8|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||79.8|-44.6|0.578
70952090|NCT00895895|141405339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.1||||0.175|TWO_SIDED|95.0|-13.9|76.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||76.1|-13.9|0.175
70952091|NCT00895895|141405339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.0||||0.352|TWO_SIDED|95.0|-23.3|65.4|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||65.4|-23.3|0.352
70952092|NCT00895895|141405339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.7||||0.797|TWO_SIDED|95.0|-38.1|49.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||49.6|-38.1|0.797
70952093|NCT00895895|141405339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9||||0.633|TWO_SIDED|95.0|-55.6|33.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||33.9|-55.6|0.633
70952094|NCT00895895|141405340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|71.2||||0.066|TWO_SIDED|95.0|-4.7|147.0|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||147.0|-4.7|0.066
70952095|NCT00895895|141405340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.0||||0.598|TWO_SIDED|95.0|-54.6|94.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||94.7|-54.6|0.598
70952096|NCT00895895|141405340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.2||||0.766|TWO_SIDED|95.0|-62.9|85.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||85.3|-62.9|0.766
70952097|NCT00895895|141405340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.8||||0.378|TWO_SIDED|95.0|-41.5|109.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||109.1|-41.5|0.378
70869267|NCT00293033|141224099|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
70952098|NCT00895895|141405341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.5||||0.481|TWO_SIDED|95.0|-40.2|85.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||85.2|-40.2|0.481
70869268|NCT00293033|141224100|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70952099|NCT00895895|141405341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2||||0.894|TWO_SIDED|95.0|-57.5|65.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||65.9|-57.5|0.894
71143897|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.71||||0.0079|TWO_SIDED|95.0|1.764|11.657|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||11.657|1.764|0.0079
71143898|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.759||||0.01|TWO_SIDED|95.0|1.613|11.905|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||11.905|1.613|0.0100
71143899|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.787||||0.0114|TWO_SIDED|95.0|1.53|12.043|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||12.043|1.530|0.0114
71143900|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.836||||0.0141|TWO_SIDED|95.0|1.378|12.293|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||12.293|1.378|0.0141
71143901|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.863||||0.0157|TWO_SIDED|95.0|1.294|12.432|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||12.432|1.294|0.0157
70869269|NCT00293033|141224101|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
70869270|NCT00293033|141224102|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
70869271|NCT00293033|141224103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.563|||||||Wilcoxon (Mann-Whitney)|||||||0.563
70869272|NCT00293033|141224104|SUPERIORITY_OR_OTHER_LEGACY|||||||0.498|||||||Wilcoxon (Mann-Whitney)|||||||0.498
70869273|NCT00293033|141224105|SUPERIORITY_OR_OTHER_LEGACY|||||||0.077|||||||Wilcoxon (Mann-Whitney)|||||||0.077
70869274|NCT00293033|141224106|SUPERIORITY_OR_OTHER_LEGACY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||||||0.031
70869275|NCT00293033|141224107|SUPERIORITY_OR_OTHER_LEGACY|||||||0.963|||||||Wilcoxon (Mann-Whitney)|||||||0.963
70869276|NCT00293033|141224108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
70869277|NCT00293033|141224109|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
70869278|NCT00293033|141224110|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
70869279|NCT00293033|141224111|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||0.100
70869280|NCT00293033|141224112|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
70869281|NCT00293033|141224113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
70869282|NCT00293033|141224114|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70869283|NCT00293033|141224115|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
70869284|NCT00293033|141224116|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
70869285|NCT00293033|141224117|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.750
70869286|NCT00293033|141224118|SUPERIORITY_OR_OTHER_LEGACY|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
70869287|NCT00293033|141224119|SUPERIORITY_OR_OTHER_LEGACY|||||||0.131|||||||Wilcoxon (Mann-Whitney)|||||||0.131
70869288|NCT00293033|141224120|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
70869289|NCT00293033|141224121|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
70952100|NCT00895895|141405341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.991|TWO_SIDED|95.0|-61.5|60.8|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||60.8|-61.5|0.991
70869290|NCT00293033|141224122|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.96|STANDARD_ERROR_OF_MEAN|2.57||0.023|TWO_SIDED|95.0|0.92|11.01|||Mixed Models Analysis|||||11.01|0.92|0.023
70869291|NCT00293033|141224123|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.84|STANDARD_ERROR_OF_MEAN|7.25||0.009|TWO_SIDED|95.0|5.63|34.04|||Mixed Models Analysis|||||34.04|5.63|0.009
70952101|NCT00895895|141405341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.5||||0.422|TWO_SIDED|95.0|-87.9|36.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||36.9|-87.9|0.422
70952102|NCT00895895|141405342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.581|TWO_SIDED|95.0|0.24|2.22|||Regression, Logistic|||||2.22|0.24|0.581
70869292|NCT00293033|141224124|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|33.26|STANDARD_ERROR_OF_MEAN|12.72||0.012|TWO_SIDED|95.0|8.32|58.2|||Mixed Models Analysis|||||58.20|8.32|0.012
70869293|NCT00293033|141224125|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|46.88|STANDARD_ERROR_OF_MEAN|18.46||0.015|TWO_SIDED|95.0|10.69|83.08|||Mixed Models Analysis|||||83.08|10.69|0.015
70869294|NCT03583697|141224127|SUPERIORITY||Least Square Mean Difference (Net)|0.25|||||TWO_SIDED|95.0|-0.02|0.53||||||"Z-Scores were derived using age-sex specific reference data (means and SDs) for average stature children per the Centers for Disease Control and Prevention.~Participants aged \< 24 months, body length takes precedence over standing height. Participants aged \< 24 months at baseline and \>= 24 months at Week 52, body length takes precedence.~Difference in least squares (LS) means were obtained from an analysis of covariance model."||0.53|-0.02|
70869295|NCT03583697|141224127|SUPERIORITY||Least Square Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|0.07|0.54||||||"Z-Scores were derived using age-sex specific reference data (means and SDs) for average stature children per the Centers for Disease Control and Prevention.~Participants aged \< 24 months, body length takes precedence over standing height. Participants aged \< 24 months at baseline and \>= 24 months at Week 52, body length takes precedence.~Difference in LS means were obtained from an analysis of covariance model."||0.54|0.07|
70869296|NCT03583697|141224128|SUPERIORITY||Least Square Mean Difference (Net)|0.77|||||TWO_SIDED|95.0|-0.02|1.56||||||Difference in LS means were obtained from an analysis of covariance model.||1.56|-0.02|
70869297|NCT03583697|141224128|SUPERIORITY||Least Square Mean Difference (Net)|0.96|||||TWO_SIDED|95.0|0.26|1.66||||||Difference in LS means were obtained from an analysis of covariance model.||1.66|0.26|
70869298|NCT03583697|141224129|SUPERIORITY||Least Square Mean Difference (Net)|0.78|||||TWO_SIDED|95.0|0.02|1.54||||||||1.54|0.02|
70869299|NCT03583697|141224129|SUPERIORITY||Least Square Mean Difference (Net)|0.92|||||TWO_SIDED|95.0|0.24|1.59||||||Difference in LS means were obtained from an analysis of covariance model.||1.59|0.24|
70869300|NCT03583697|141224130|SUPERIORITY||Least Square Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-0.17|0.04||||||Difference in LS means were obtained from an analysis of covariance model.||0.04|-0.17|
70869301|NCT03583697|141224130|SUPERIORITY||Least Square Mean Difference (Net)|-0.06|||||TWO_SIDED|95.0|-0.15|0.03||||||Difference in LS means were obtained from an analysis of covariance model.||0.03|-0.15|
70869302|NCT00114530|141224183|SUPERIORITY|||||||0.013||||||A Data and Safety Monitoring Board reviewed 4 pre-specified futility analyses that included an ability to stop for efficacy with p\<0.0001, leaving alpha equal to 0.0496 for the primary ITT analysis of the GRCS at 54 months post-randomization.|Wilcoxon (Mann-Whitney)|||||||0.013
70869303|NCT00114530|141224184|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
70869304|NCT00114530|141224185|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
70869305|NCT00114530|141224186|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
70869306|NCT00114530|141224187|SUPERIORITY|||||||0.059|||||||Fisher Exact|||Treatment arm comparisons of EFS at Month 54.||||0.059
70869307|NCT00114530|141224187|SUPERIORITY|||||||0.06|||||||Log Rank|||Treatment arm comparisons of Kaplan-Meier curves for EFS through Month 72||||0.06
70869308|NCT00114530|141224188|SUPERIORITY|||||||0.021|||||||Fisher Exact|||Treatment arm comparisons of EFS at Month 54.||||0.021
70869309|NCT00114530|141224188|SUPERIORITY|||||||0.03|||||||Log Rank|||Treatment arm comparisons of Kaplan-Meier curves for EFS through Month 72||||0.03
70869310|NCT00114530|141224189|SUPERIORITY|||||||0.059|||||||Fisher Exact|||||||0.059
70869311|NCT00114530|141224190|SUPERIORITY|||||||0.021|||||||Fisher Exact|||||||0.021
70869312|NCT00114530|141224191|SUPERIORITY|||||||0.48|||||||Fisher Exact|||||||0.48
70952103|NCT00895895|141405342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.77|TWO_SIDED|95.0|0.42|3.19|||Regression, Logistic|||||3.19|0.42|0.770
70952104|NCT00895895|141405342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.216|TWO_SIDED|95.0|0.71|4.55|||Regression, Logistic|||||4.55|0.71|0.216
70952105|NCT00895895|141405342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.61||||0.037|TWO_SIDED|95.0|1.06|6.42|||Regression, Logistic|||||6.42|1.06|0.037
70952106|NCT00504777|141405344|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70869313|NCT00114530|141224192|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
70869314|NCT00114530|141224193|SUPERIORITY|||||||0.48|||||||Fisher Exact|||||||0.48
70869315|NCT00114530|141224194|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
70869316|NCT00114530|141224195|SUPERIORITY|||||||0.28|||||||Fisher Exact|||Treatment arm comparisons of overall survival at Month 54.||||0.28
70869317|NCT00114530|141224195|SUPERIORITY|||||||0.05|||||||Log Rank|||Treatment arm comparisons of Kaplan-Meier curves for overall survival through Month 72.||||0.05
70869318|NCT00114530|141224196|SUPERIORITY|||||||0.19|||||||Fisher Exact|||Treatment arm comparisons of overall survival at Month 54.||||0.19
70869319|NCT00114530|141224196|SUPERIORITY|||||||0.02|||||||Log Rank|||Treatment arm comparisons of Kaplan-Meier curves for overall survival through Month 72.||||0.02
70869320|NCT00114530|141224197|SUPERIORITY|||||||0.28|||||||Fisher Exact|||||||0.28
70869321|NCT00114530|141224198|SUPERIORITY|||||||0.19|||||||Fisher Exact|||||||0.19
70869322|NCT00114530|141224199|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||<0.001
70869323|NCT00114530|141224199|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.01
70952107|NCT00504777|141405347|SUPERIORITY_OR_OTHER|||||||0.0054|||||||t-test, 2 sided|||||||0.0054
70869324|NCT00114530|141224200|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||<0.001
70869325|NCT00114530|141224200|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.002
70952108|NCT01621776|141405352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|145.1|STANDARD_DEVIATION|78.04||0.971||95.0|129.73|160.47|||ANOVA||This is a three arm study that is not seeking to engage in comparison between individual arms, therefore the mean difference across the study arms is reported.|||160.47|129.73|.971
70869326|NCT00114530|141224201|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||Physical Component Score. This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.001
70869327|NCT00114530|141224201|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||Physical Component Score. This analysis is stratified by EFS status.||||0.02
70869328|NCT00114530|141224201|SUPERIORITY|||||||0.05|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||Mental Component Score. This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.05
70869329|NCT00114530|141224201|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||Mental Component Score. This analysis is stratified by EFS status.||||0.1
70869330|NCT00114530|141224202|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||Physical Component Score. This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||<0.001
70869331|NCT00114530|141224202|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||Physical Component Score. This analysis is stratified by EFS status.||||0.003
70869332|NCT00114530|141224202|SUPERIORITY|||||||0.02|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||Mental Component Score. This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.02
70869333|NCT00114530|141224202|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||Mental Component Score. This analysis is stratified by EFS status.||||0.07
70869334|NCT00114530|141224203|SUPERIORITY|||||||0.08|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.08
70869335|NCT00114530|141224203|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.9
70869336|NCT00114530|141224204|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.1
70869337|NCT00114530|141224204|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.6
70869338|NCT00114530|141224205|SUPERIORITY|||||||0.02|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.02
70869339|NCT00114530|141224205|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.3
70869340|NCT00114530|141224206|SUPERIORITY|||||||0.03|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.03
70869341|NCT00114530|141224206|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.5
70869342|NCT00114530|141224207|SUPERIORITY|||||||0.002|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.002
70869343|NCT00114530|141224207|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.05
70952109|NCT01621776|141405353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|161.09|STANDARD_DEVIATION|62.67||0.698|TWO_SIDED|95.0|144.91|177.28|||ANOVA||This is a three arm study that is not seeking to engage in comparison between individual arms, therefore the mean difference across the study arms is reported.|||177.28|144.91|.698
70952110|NCT01621776|141405354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|220.46|STANDARD_DEVIATION|89.97||0.806|TWO_SIDED|95.0|197.22|243.71|||ANOVA||This is a three arm study that is not seeking to engage in comparison between individual arms, therefore the mean difference across the study arms is reported.|||243.71|197.22|.806
70952111|NCT00755105|141405359|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||< 0.05
70952112|NCT03995316|141405360|SUPERIORITY||Slope|-0.76|STANDARD_ERROR_OF_MEAN|0.25||0.003|TWO_SIDED||||||t-test, 2 sided||The slope value reflects the mean difference between conditions in the linear slope from the pretest to posttest assessment.|||||.003
70952113|NCT03995316|141405361|SUPERIORITY||Slope|-0.18|STANDARD_ERROR_OF_MEAN|0.17||0.283|TWO_SIDED||||||t-test, 2 sided||The slope value reflects the mean difference between conditions in the linear slope from the pretest to posttest assessment.|||||.283
70869344|NCT00114530|141224208|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||<0.001
70869345|NCT00114530|141224208|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.01
70952114|NCT03995316|141405362|SUPERIORITY||Slope|-0.51|STANDARD_ERROR_OF_MEAN|0.22||0.019|TWO_SIDED||||||t-test, 2 sided||The slope value reflects the mean difference between conditions in the linear slope from the pretest to posttest assessment.|||||.019
71143902|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.912||||0.0189|TWO_SIDED|95.0|1.142|12.683|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||12.683|1.142|0.0189
71143903|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.94||||0.0208|TWO_SIDED|95.0|1.057|12.822|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||12.822|1.057|0.0208
71143904|NCT00083889|141781652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.989||||0.0244|TWO_SIDED|95.0|0.904|13.074|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||13.074|0.904|0.0244
71143905|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.459|||<|0.0001|TWO_SIDED|95.0|0.805|2.114|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) Physical Well Being (PWB) subscale baseline score (intercept and time since randomization are included as random effects).||2.114|0.805|<.0001
71143906|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.453|||<|0.0001|TWO_SIDED|95.0|0.827|2.079|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.079|0.827|<.0001
71143907|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.45|||<|0.0001|TWO_SIDED|95.0|0.837|2.063|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.063|0.837|<.0001
71143908|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.444|||<|0.0001|TWO_SIDED|95.0|0.847|2.041|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.041|0.847|<.0001
71143909|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44|||<|0.0001|TWO_SIDED|95.0|0.848|2.032|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.032|0.848|<.0001
71143910|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.434|||<|0.0001|TWO_SIDED|95.0|0.844|2.024|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.024|0.844|<.0001
71143911|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.431|||<|0.0001|TWO_SIDED|95.0|0.838|2.023|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.023|0.838|<.0001
70869346|NCT00114530|141224209|SUPERIORITY|||||||0.42|||||||Chi-squared|||Development of new or worsening arrhythmias||||0.42
70869347|NCT00114530|141224209|SUPERIORITY|||||||0.048|||||||Chi-squared|||CHF requiring clinical treatment||||0.048
70869348|NCT00114530|141224209|SUPERIORITY|||||||0.51|||||||Chi-squared|||Clinically significant pericardial effusion||||0.51
70952115|NCT03995316|141405363|SUPERIORITY||Slope|0.34|STANDARD_ERROR_OF_MEAN|0.44||0.44|TWO_SIDED||||||t-test, 2 sided||The slope value reflects the mean difference between conditions in the linear slope from the pretest to posttest assessment.|||||.440
70952116|NCT03995316|141405364|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.03||0.055|TWO_SIDED||||||t-test, 2 sided||The slope value reflects the mean difference between conditions in the linear slope from the pretest to posttest assessment.|||||.055
70952117|NCT03995316|141405365|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.04||0.041|TWO_SIDED||||||t-test, 2 sided||The slope value reflects the mean difference between conditions in the linear slope from the pretest to posttest assessment.|||||.041
70952118|NCT00203268|141405378|SUPERIORITY_OR_OTHER|||||||0.3025|||||||clustered survival analysis|||||||.3025
70869349|NCT00114530|141224210|SUPERIORITY|||||||0.46|||||||Chi-squared|||Development of new or worsening arrhythmias||||0.46
70869350|NCT00114530|141224210|SUPERIORITY|||||||0.042|||||||Chi-squared|||CHF requiring clinical treatment||||0.042
70952119|NCT03852719|141405419|OTHER||Difference in percentages|46.0|||<|0.0001|TWO_SIDED|96.0|30.5|61.4||Fisher's exact test was used for comparison of bulevirtide 10 mg versus Delayed Treatment using a significance level of 0.04 at Week 48.|Fisher Exact|||||61.4|30.5|<0.0001
70952120|NCT03852719|141405419|OTHER||Difference in percentages|42.9|||<|0.0001|TWO_SIDED|96.0|27.0|58.5||Fisher's exact test was used for comparison of bulevirtide 2 mg versus Delayed Treatment using a significance level of 0.04 at Week 48.|Fisher Exact|||||58.5|27.0|<0.0001
71143912|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.424|||<|0.0001|TWO_SIDED|95.0|0.819|2.029|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.029|0.819|<.0001
71143913|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.421|||<|0.0001|TWO_SIDED|95.0|0.805|2.037|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.037|0.805|<.0001
71143914|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.415|||<|0.0001|TWO_SIDED|95.0|0.774|2.056|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.056|0.774|<.0001
71143915|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.411|||<|0.0001|TWO_SIDED|95.0|0.753|2.069|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.069|0.753|<.0001
71143916|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.405|||<|0.0001|TWO_SIDED|95.0|0.711|2.099|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.099|0.711|<.0001
71143917|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.402||||0.0001|TWO_SIDED|95.0|0.685|2.119|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.119|0.685|0.0001
71143918|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.396||||0.0003|TWO_SIDED|95.0|0.634|2.157|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.157|0.634|0.0003
71143919|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.392||||0.0005|TWO_SIDED|95.0|0.604|2.18|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.180|0.604|0.0005
71143920|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.386||||0.0012|TWO_SIDED|95.0|0.547|2.225|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.225|0.547|0.0012
71143921|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.383||||0.0018|TWO_SIDED|95.0|0.514|2.252|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.252|0.514|0.0018
71143922|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.376||||0.0035|TWO_SIDED|95.0|0.451|2.301|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.301|0.451|0.0035
71143923|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.373||||0.0049|TWO_SIDED|95.0|0.416|2.33|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.330|0.416|0.0049
71143924|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.367||||0.0084|TWO_SIDED|95.0|0.35|2.383|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.383|0.350|0.0084
70869351|NCT00114530|141224210|SUPERIORITY|||||||0.15|||||||Chi-squared|||Clinically significant pericardial effusion||||0.15
70869352|NCT00114530|141224211|SUPERIORITY|||||||0.026|||||||Chi-squared|||||||0.026
70869353|NCT00114530|141224212|SUPERIORITY|||||||0.022|||||||Chi-squared|||||||0.022
70869354|NCT00114530|141224213|SUPERIORITY|||||||0.71|||||||Chi-squared|||||||0.71
70869355|NCT00114530|141224214|SUPERIORITY|||||||0.32|||||||Chi-squared|||||||0.32
70869356|NCT00114530|141224215|SUPERIORITY|||||||0.3|||||||Chi-squared|||||||0.30
70869357|NCT00114530|141224216|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||0.31
70869358|NCT00114530|141224217|SUPERIORITY|||||||0.002|||||||Chi-squared|||||||0.002
70869359|NCT00114530|141224218|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
70869360|NCT00114530|141224219|SUPERIORITY||||||<|0.001|||||||Regression, Linear|P-value comes from a Poisson regression comparing the person-year adjusted event rates between the two treatment groups.||||||<0.001
70952121|NCT03852719|141405420|OTHER||Difference in percentages|7.8||||0.4139|TWO_SIDED|96.0|-8.5|24.3||Fisher's exact test was used for the comparison of bulevirtide 10 mg versus bulevirtide 2 mg using a significance level of 0.04 at Week 48.|Fisher Exact|||||24.3|-8.5|0.4139
70869361|NCT00114530|141224219|SUPERIORITY||Person-Time (Years)|174.4|||||TWO_SIDED||||||||The Person-Time (P-T) rates (events/P-T) are as follows: Possibly related = 0.61, Probably related = 0.57, Definitely related = 0.52|||||
70869362|NCT00114530|141224219|SUPERIORITY||Person-Time (Years)|141.3|||||TWO_SIDED||||||||The Person-Time (P-T) rates (events/P-T) are as follows: Possibly related = 0.17, Probably related = 0.09, Definitely related = 0.04|||||
70869363|NCT00114530|141224221|SUPERIORITY|||||||0.7|||||||Regression, Linear|P-value comes from a Poisson regression comparing the person-year adjusted event rates between the two treatment groups.||||||0.7
70869364|NCT00114530|141224221|SUPERIORITY||Person-Time (Years)|174.4|||||TWO_SIDED||||||||The Person-Time (P-T) rate (events/P-T) is 0.76|||||
70869365|NCT00114530|141224221|SUPERIORITY||Person-Time (Years)|141.3|||||TWO_SIDED||||||||The Person-Time (P-T) rate (events/P-T) is 0.80|||||
70869366|NCT00365508|141224225|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||a priori threshold for statistical significance|Chi-squared|||Chi-square was used to examine the relationship between treatment arm and 24-hour point prevalence abstinence at 6-months.||||.05
70869367|NCT01064310|141224228|SUPERIORITY_OR_OTHER||Percentage of participants|49.26|||<|0.001|TWO_SIDED|90.0|37.0|61.5||The p value indicates the difference in preference for pazopanib versus sunitinib treatment|Prescotts test||The estimated value indicates the difference in the percentage of participants who preferred pazopanib versus sunitinib. This difference is adjusted for sequence.|||61.5|37.0|<0.001
70869368|NCT00679432|141224239|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|5.8||||0.1393|TWO_SIDED|95.0|-1.8|13.4|||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|All p-values were based on the Chi-square test; comparisons of budesonide MMX and placebo were conducted at the α = 0.025 level of significance and the comparison of Asacol and placebo were conducted at the α = 0.05 level of significance. The study was not powered to show statistical significance for Asacol versus budesonide MMX.||13.4|-1.8|0.1393
70869369|NCT00679432|141224239|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|10.4||||0.0143|TWO_SIDED|95.0|2.2|18.7|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||18.7|2.2|0.0143
70869370|NCT00679432|141224239|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|4.7||||0.22|TWO_SIDED|95.0|-2.7|12.1|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||12.1|-2.7|0.2200
70869371|NCT00679432|141224240|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|5.8||||0.3146|TWO_SIDED|95.0|-5.5|17.0|||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|Clinical improvement and endoscopic improvement were analyzed hierarchically. If at least one primary endpoint comparison was statistically significant, clinical improvement was to be compared between each budesonide MMX group and placebo at the α = 0.025 level of significance. If at least one comparison of clinical improvement was statistically significant, endoscopic improvement was to be compared between each budesonide MMX dose group and placebo at the α = 0.025 level of significance.||17.0|-5.5|0.3146
70952122|NCT03852719|141405421|OTHER||Difference in percentages|39.3|||<|0.0001|TWO_SIDED|95.0|20.0|55.8||Fisher's exact test was used for comparison of bulevirtide 2 mg versus Delayed treatment using a significance level of 0.05.|Fisher Exact|||||55.8|20.0|<0.0001
70869372|NCT00679432|141224240|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|8.5||||0.142|TWO_SIDED|95.0|-2.8|19.9|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||19.9|-2.8|0.1420
70869373|NCT00679432|141224240|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|9.1||||0.1189|TWO_SIDED|95.0|-2.3|20.4|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||20.4|-2.3|0.1189
70869374|NCT00679432|141224241|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|0.0||||0.9991|TWO_SIDED|95.0|-11.8|11.8|||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|As per the hierarchical testing procedure for secondary endpoints, because clinical improvement was not statistically significant in the ITT population, formal statistical comparisons for endoscopic improvement between the 2 budesonide MMX groups and placebo were not conducted. The statistical comparison between the Asacol and placebo groups is shown here.||11.8|-11.8|0.9991
70869375|NCT00873912|141224290|NON_INFERIORITY_OR_EQUIVALENCE|Based on similar fever rate with 300 evaluable subjects (240 vaccine and 60 placebo recipients), the study would provide at least 98% power to rule out a rate increase of 5 percentage points assuming the true difference between the treatment groups is zero and the true fever rate is ≤ 1.0%. Power would be lower if the true difference was different from zero.|rate difference|-1.3|||||TWO_SIDED|95.0|-7.9|1.3|||score statistic|||The percentage of subjects with fever was compared between the two treatment groups based on the upper limit of the two-sided 95% CIs for rate difference (monovalent vaccine minus placebo). The upper limit of the two-sided 95% CI was evaluated against the pre-specified equivalence criterion of 5 percentage points which corresponded to the following hypotheses: - H0 (null): rate difference ≥ 5 percentage points, - HA (alternative): rate difference \< 5 percentage points.||1.3|-7.9|
70869376|NCT01980940|141224302|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|5.09|||||TWO_SIDED|90.0|4.03|6.42|||ANOVA|||The geometric least squares mean ratio (GLSMR) and 90% confidence interval was calculated for Cmax after log transformation for the formulation comparison (ETOR 75 DMSO/ETOR 75 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. Cmax with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||6.42|4.03|
70869377|NCT01980940|141224302|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|7.3|||||TWO_SIDED|90.0|6.05|8.81|||ANOVA|||The GLSMR and 90% confidence interval was calculated for Cmax after log transformation for the formulation comparison (ETOR 150 DMSO/ETOR 150 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. Cmax with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||8.81|6.05|
70869378|NCT01980940|141224302|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|0.45|||||TWO_SIDED|90.0|0.38|0.55|||ANOVA|||The GLSMR and 90% confidence interval was calculated for Cmax after log transformation for the dose comparison (ETOR 75 DMSO/ETOR 150 DMSO) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. Cmax with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||0.55|0.38|
70869379|NCT01980940|141224302|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|0.65|||||TWO_SIDED|90.0|0.51|0.83|||ANOVA|||The GLSMR and 90% confidence interval was calculated for Cmax after log transformation for the dose comparison (ETOR 75 PG/ETOR 150 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. Cmax with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||0.83|0.51|
70869380|NCT01980940|141224304|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|9.32|||||TWO_SIDED|90.0|4.77|18.18|||ANOVA|||The GLSMR and 90% confidence interval was calculated for AUC0-last after log transformation for the formulation comparison (ETOR 75 DMSO/ETOR 75 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. AUC with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||18.18|4.77|
70869381|NCT01980940|141224304|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|8.12|||||TWO_SIDED|90.0|6.39|10.32|||ANOVA|||The GLSMR and 90% confidence interval was calculated for AUC0-last after log transformation for the formulation comparison (ETOR 150 DMSO/ETOR 150 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. AUC with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||10.32|6.39|
70869382|NCT01980940|141224304|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|0.47|||||TWO_SIDED|90.0|0.39|0.57|||ANOVA|||The GLSMR and 90% confidence interval was calculated for AUC0-last after log transformation for the dose comparison (ETOR 75 DMSO/ETOR 150 DMSO) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. AUC with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||0.57|0.39|
70869383|NCT01980940|141224304|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|0.41|||||TWO_SIDED|90.0|0.21|0.79|||ANOVA|||The GLSMR and 90% confidence interval was calculated for AUC0-last after log transformation for the dose comparison (ETOR 75 PG/ETOR 150 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. AUC with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||0.79|0.21|
70869384|NCT01980940|141224305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-27.3|STANDARD_ERROR_OF_MEAN|21.57||0.2113|TWO_SIDED|90.0|-63.6|8.9|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 2 in the WOMAC VA 3.1 pain subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 2 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||8.9|-63.6|0.2113
70869385|NCT01980940|141224305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.7|STANDARD_ERROR_OF_MEAN|19.66||0.2548|TWO_SIDED|90.0|-55.7|10.3|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 4 in the WOMAC VA 3.1 pain subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 4 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||10.3|-55.7|0.2548
70952123|NCT03852719|141405421|OTHER||Difference in percentage|44.2|||<|0.0001|TWO_SIDED|95.0|25.8|59.9||Fisher's exact test was used for comparison of bulevirtide 10 mg versus Delayed treatment using a significance level of 0.05.|Fisher Exact|||||59.9|25.8|<0.0001
70952124|NCT03852719|141405422|OTHER||Difference in LS Mean|-4.02||||0.001|TWO_SIDED|95.0|-6.39|-1.65|||ANCOVA|||||-1.65|-6.39|0.0010
70869386|NCT01980940|141224305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-21.4|STANDARD_ERROR_OF_MEAN|19.94||0.288|TWO_SIDED|90.0|-54.9|12.0|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 7 in the WOMAC VA 3.1 pain subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 7 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||12.0|-54.9|0.2880
70869387|NCT01980940|141224305|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-17.6|STANDARD_ERROR_OF_MEAN|19.52||0.3709|TWO_SIDED|90.0|-50.4|15.1|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 11 in the WOMAC VA 3.1 pain subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 11 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||15.1|-50.4|0.3709
70869388|NCT01980940|141224305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.3|STANDARD_ERROR_OF_MEAN|19.81||0.3883|TWO_SIDED|90.0|-50.5|16.0|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 14 in the WOMAC VA 3.1 pain subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 14 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||16.0|-50.5|0.3883
70869389|NCT01980940|141224306|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.1|STANDARD_ERROR_OF_MEAN|9.32||0.1383|TWO_SIDED|90.0|-29.7|1.6|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 2 in the WOMAC VA 3.1 stiffness subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 2 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||1.6|-29.7|0.1383
70869390|NCT01980940|141224306|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|8.66||0.238|TWO_SIDED|90.0|-24.9|4.2|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 4 in the WOMAC VA 3.1 stiffness subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 4 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||4.2|-24.9|0.2380
70869391|NCT01980940|141224306|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.5|STANDARD_ERROR_OF_MEAN|8.53||0.2691|TWO_SIDED|90.0|-23.9|4.8|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 7 in the WOMAC VA 3.1 stiffness subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 7 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||4.8|-23.9|0.2691
70869392|NCT01980940|141224306|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.1|STANDARD_ERROR_OF_MEAN|8.15||0.3246|TWO_SIDED|90.0|-21.8|5.6|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 11 in the WOMAC VA 3.1 stiffness subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 11 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||5.6|-21.8|0.3246
70869393|NCT01980940|141224306|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.1|STANDARD_ERROR_OF_MEAN|8.19||0.3881|TWO_SIDED|90.0|-20.9|6.6|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 14 in the WOMAC VA 3.1 stiffness subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 14 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||6.6|-20.9|0.3881
70869394|NCT01980940|141224307|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-52.3|STANDARD_ERROR_OF_MEAN|68.25||0.4477|TWO_SIDED|90.0|-166.8|62.3|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 2 in the WOMAC VA 3.1 physical function subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 2 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||62.3|-166.8|0.4477
70869395|NCT01980940|141224307|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-33.7|STANDARD_ERROR_OF_MEAN|65.42||0.6084|TWO_SIDED|90.0|-143.6|76.1|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 4 in the WOMAC VA 3.1 physical function subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 4 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||76.1|-143.6|0.6084
70952125|NCT03852719|141405422|OTHER||Difference in LS Mean|-3.93||||0.0009|TWO_SIDED|95.0|-6.23|-1.63|||ANCOVA|||||-1.63|-6.23|0.0009
70952126|NCT03852719|141405423|OTHER||Difference in Least Square (LS) Mean|0.57||||0.5156|TWO_SIDED|95.0|-1.16|2.3|||MMRM|||||2.30|-1.16|0.5156
70952127|NCT03852719|141405424|OTHER||Difference in Least Square (LS) Mean|-1.21||||0.2977|TWO_SIDED|95.0|-3.5|1.08|||MMRM|||||1.08|-3.50|0.2977
70952128|NCT03852719|141405425|SUPERIORITY||LS-Mean of Diffrence|-0.04||||0.9719|TWO_SIDED|95.0|-2.23|2.15||P-value was based on the mixed-effects model for repeated measurements (MMRM) model.|MMRM||Least squares (LS) means, standard errors (SE), 95% CIs and p-values were based on the mixed-effects model for repeated measurements (MMRM) model for change from baseline.|||2.15|-2.23|0.9719
70952129|NCT03852719|141405426|SUPERIORITY|P-value was based on the mixed-effects model for repeated measurements (MMRM) model.|LS-Mean of Difference|2.11||||0.2369|TWO_SIDED|95.0|-1.41|5.63|||MMRM||Least squares (LS) means, standard errors (SE), 95% CIs and p-values were based on the mixed-effects model for repeated measurements (MMRM) model for change from baseline.|||5.63|-1.41|0.2369
70952130|NCT03852719|141405427|SUPERIORITY||Response Rate Difference|7.6||||0.4695|TWO_SIDED|95.0|-9.6|24.4||P-value was based on Fisher's Exact Test.|Fisher Exact||For response rate difference, the 95% exact unconditional confidence interval (CI) based on the score statistic was presented.|||24.4|-9.6|0.4695
71143925|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.363||||0.011|TWO_SIDED|95.0|0.313|2.414|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.414|0.313|0.0110
71143926|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.357||||0.0168|TWO_SIDED|95.0|0.245|2.47|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.470|0.245|0.0168
71143927|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.354||||0.0208|TWO_SIDED|95.0|0.206|2.501|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.501|0.206|0.0208
71143928|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.348||||0.0293|TWO_SIDED|95.0|0.136|2.559|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.559|0.136|0.0293
71143929|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.344||||0.0348|TWO_SIDED|95.0|0.096|2.592|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.592|0.096|0.0348
71143930|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.338||||0.0459|TWO_SIDED|95.0|0.024|2.652|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.652|0.024|0.0459
71143931|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.335||||0.0528|TWO_SIDED|95.0|-0.016|2.685|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.685|-0.016|0.0528
71143932|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.328||||0.0663|TWO_SIDED|95.0|-0.09|2.746|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.746|-0.090|0.0663
71143933|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.325||||0.0744|TWO_SIDED|95.0|-0.131|2.78|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.780|-0.131|0.0744
71143934|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.319||||0.0898|TWO_SIDED|95.0|-0.205|2.842|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.842|-0.205|0.0898
70869396|NCT01980940|141224307|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-35.2|STANDARD_ERROR_OF_MEAN|65.25||0.5926|TWO_SIDED|90.0|-144.7|74.4|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 7 in the WOMAC VA 3.1 physical function subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 7 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||74.4|-144.7|0.5926
71143935|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.315||||0.0988|TWO_SIDED|95.0|-0.246|2.877|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.877|-0.246|0.0988
71143936|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.309||||0.1156|TWO_SIDED|95.0|-0.321|2.94|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.940|-0.321|0.1156
70952131|NCT03852719|141405427|SUPERIORITY||Response Rate Difference|-0.4||||1|TWO_SIDED|95.0|-16.3|15.5||P-value was based on Fisher's Exact Test.|Fisher Exact||For response rate difference, the 95% exact unconditional confidence interval (CI) based on the score statistic was presented|||15.5|-16.3|1.0000
71143937|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.306||||0.1252|TWO_SIDED|95.0|-0.363|2.975|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.975|-0.363|0.1252
70952132|NCT03852719|141405428|SUPERIORITY||Response Rate Difference|7.7||||0.4539|TWO_SIDED|95.0|-8.8|24.0||P-value was based on Fisher's Exact Test.|Fisher Exact||For response rate difference, the 95% exact unconditional confidence interval (CI) based on the score statistic was presented|||24.0|-8.8|0.4539
70952133|NCT03852719|141405428|SUPERIORITY||Response Rate Difference|-0.3||||1|TWO_SIDED|95.0|-15.6|15.5||P-value was based on Fisher's Exact Test.|Fisher Exact||For response rate difference, the 95% exact unconditional confidence interval (CI) based on the score statistic was presented.|||15.5|-15.6|1.0000
71143938|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.1429|TWO_SIDED|95.0|-0.439|3.038|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.038|-0.439|0.1429
70869397|NCT01980940|141224307|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-42.3|STANDARD_ERROR_OF_MEAN|62.49||0.5022|TWO_SIDED|90.0|-147.2|62.6|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 11 in the WOMAC VA 3.1 physical function subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 11 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||62.6|-147.2|0.5022
70952134|NCT02819024|141405430|OTHER|||||||0.087|||||||t-test, 2 sided|||||||0.087
71143939|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.296||||0.1529|TWO_SIDED|95.0|-0.481|3.074|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.074|-0.481|0.1529
71143940|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29||||0.1711|TWO_SIDED|95.0|-0.558|3.138|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.138|-0.558|0.1711
71143941|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.287||||0.1813|TWO_SIDED|95.0|-0.6|3.173|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.173|-0.600|0.1813
71143942|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.28||||0.1998|TWO_SIDED|95.0|-0.677|3.238|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.238|-0.677|0.1998
71143943|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.277||||0.21|TWO_SIDED|95.0|-0.72|3.273|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.273|-0.720|0.2100
71143944|NCT00083889|141781653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.271||||0.2283|TWO_SIDED|95.0|-0.797|3.338|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.338|-0.797|0.2283
71143945|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.214|||<|0.0001|TWO_SIDED|95.0|0.719|1.708|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) Social/Family Well Being (SWB) subscale baseline score (intercept and time since randomization are included as random effects).||1.708|0.719|<.0001
71143946|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.216|||<|0.0001|TWO_SIDED|95.0|0.729|1.703|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.703|0.729|<.0001
71143947|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.217|||<|0.0001|TWO_SIDED|95.0|0.731|1.704|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.704|0.731|<.0001
71143948|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.22|||<|0.0001|TWO_SIDED|95.0|0.73|1.71|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.710|0.730|<.0001
70952135|NCT04944290|141405439|EQUIVALENCE|8AM Day 14|Mean Difference (Net)|-0.14|||||TWO_SIDED|95.0|-0.71|0.51||||||||0.51|-0.71|
70952136|NCT04944290|141405439|EQUIVALENCE|10AM Day 14|Mean Difference (Net)|-0.35|||||TWO_SIDED|95.0|-0.86|0.26||||||10AM Day 14||0.26|-0.86|
70952137|NCT04944290|141405439|EQUIVALENCE|8AM Day 42|Mean Difference (Net)|-0.04|||||TWO_SIDED|95.0|-0.58|0.58||||||||0.58|-0.58|
70952138|NCT04944290|141405439|EQUIVALENCE|10AM Day 42|Mean Difference (Net)|-0.16|||||TWO_SIDED|95.0|-0.7|0.47||||||||0.47|-0.70|
70869398|NCT01980940|141224307|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-42.0|STANDARD_ERROR_OF_MEAN|63.7||0.5125|TWO_SIDED|90.0|-149.0|64.9|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 14 in the WOMAC VA 3.1 physical function subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 14 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||64.9|-149.0|0.5125
70869399|NCT01980940|141224308|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2632|||||||Jonckheere-Terpstra test|||Treatment comparison of Day 2 PGART frequencies (ETOR 50 DMSO vs Placebo \[Pt 2\]) was performed using a two-sided Jonckheere-Terpstra test.||||0.2632
70869400|NCT01980940|141224308|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4703|||||||Jonckheere-Terpstra test|||Treatment comparison of Day 4 PGART frequencies (ETOR 50 DMSO vs Placebo \[Pt 2\]) was performed using a two-sided Jonckheere-Terpstra test.||||0.4703
70952139|NCT02224703|141405476|SUPERIORITY||Treatment Ratio|0.743||||0.0299|TWO_SIDED|95.0|0.568|0.971|||Negative binomial regression|||Model includes total number of seizures as a response variable and age group, time (baseline and treatment period), treatment, and treatment by time interaction as fixed effects, and participant as a random effect. Log-transformed number of days in which seizures were reported by period is included as an offset. Null hypothesis was that the ratio of GWP42003-P to placebo would be 1.||0.971|0.568|0.0299
70952140|NCT02224703|141405476|SUPERIORITY||Treatment Ratio|0.702||||0.0095|TWO_SIDED|95.0|0.538|0.916|||Negative binomial regression|||Model includes total number of seizures as a response variable and age group, time (baseline and treatment period), treatment, and treatment by time interaction as fixed effects, and participant as a random effect. Log-transformed number of days in which seizures were reported by period is included as an offset. Null hypothesis was that the ratio of GWP42003-P to placebo would be 1.||0.916|0.538|0.0095
70952141|NCT02224703|141405477|SUPERIORITY||Treatment Ratio|0.749||||0.0255|TWO_SIDED|95.0|0.581|0.965|||Negative binomial regression|||Model includes total number of seizures as a response variable and age group, time (baseline and treatment period), treatment, and treatment by time interaction as fixed effects, and participant as a random effect. Log-transformed number of days in which seizures were reported by period is included as an offset.||0.965|0.581|0.0255
70952142|NCT02224703|141405477|SUPERIORITY||Treatment Ratio|0.62||||0.0003|TWO_SIDED|95.0|0.481|0.799|||Negative binomial regression|||Model includes total number of seizures as a response variable and age group, time (baseline and treatment period), treatment, and treatment by time interaction as fixed effects, and participant as a random effect. Log-transformed number of days in which seizures were reported by period is included as an offset.||0.799|0.481|0.0003
70952143|NCT02224703|141405478|SUPERIORITY||Odds Ratio (OR)|2.74||||0.0069|TWO_SIDED|95.0|1.32|5.7|||Cochran-Mantel-Haenszel|P-value calculated from a Cochran-Mantel-Haenszel test stratified by age group (2-5, 6-12, and 13-18 years).||||5.70|1.32|0.0069
70952144|NCT02224703|141405478|SUPERIORITY||Odds Ratio (OR)|2.21||||0.0332|TWO_SIDED|95.0|1.06|4.62|||Cochran-Mantel-Haenszel|P-value calculated from a Cochran-Mantel-Haenszel test stratified by age group (2-5, 6-12, and 13-18 years).||||4.62|1.06|0.0332
70952145|NCT02224703|141405479|SUPERIORITY||Odds Ratio (OR)|2.02||||0.0279|TWO_SIDED|95.0|1.08|3.78|||Regression, Logistic||Proportional odds modelling was carried out by including treatment group as a fixed factor. The estimated OR tested the null hypothesis that OR was equal to 1.|||3.78|1.08|0.0279
71143949|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.221|||<|0.0001|TWO_SIDED|95.0|0.727|1.716|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.716|0.727|<.0001
71143950|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.224|||<|0.0001|TWO_SIDED|95.0|0.716|1.732|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.732|0.716|<.0001
70952146|NCT02224703|141405479|SUPERIORITY||Odds Ratio (OR)|2.93||||0.0009|TWO_SIDED|95.0|1.56|5.53|||Regression, Logistic||Proportional odds modelling was carried out by including treatment group as a fixed factor. The estimated OR tested the null hypothesis that OR was equal to 1.|||5.53|1.56|0.0009
70952147|NCT03031496|141405508|EQUIVALENCE|Bioequivalence of hydrochlorothiazide and amiloride hydrochloride was determined.|Least square mean ratio|91.52|||||TWO_SIDED|90.0|87.77|95.43|||||Comparison of AUC (0-t) of hydrochlorothiazide for test and reference product has been presented.|||95.43|87.77|
71143951|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.225|||<|0.0001|TWO_SIDED|95.0|0.707|1.744|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.744|0.707|<.0001
70952148|NCT03031496|141405508|EQUIVALENCE|Bioequivalence of hydrochlorothiazide and amiloride hydrochloride was determined.|Least square mean ratio|102.42|||||TWO_SIDED|90.0|98.12|106.91|||||Comparison of AUC (0-t) of amiloride for test and reference product has been presented.|||106.91|98.12|
70952149|NCT03031496|141405509|EQUIVALENCE|Bioequivalence of hydrochlorothiazide and amiloride hydrochloride was determined.|Least square mean ratio|82.86|||||TWO_SIDED|90.0|77.37|88.74|||||Comparison of Cmax of hydrochlorothiazide for test and reference product has been presented.|||88.74|77.37|
70952150|NCT03031496|141405509|EQUIVALENCE|Bioequivalence of hydrochlorothiazide and amiloride hydrochloride was determined.|Least square mean ratio|103.92|||||TWO_SIDED|90.0|97.42|110.86|||||Comparison of Cmax of amiloride for test and reference product has been presented.|||110.86|97.42|
70952151|NCT03031496|141405510|EQUIVALENCE|Bioequivalence of hydrochlorothiazide and amiloride hydrochloride was determined.|Least square mean ratio|92.37|||||TWO_SIDED|90.0|88.75|96.12|||||Comparison of Tmax of hydrochlorothiazide for test and reference product has been presented.|||96.12|88.75|
70952152|NCT03031496|141405510|OTHER||Least square mean ratio|101.47|||||TWO_SIDED|90.0|97.84|105.23|||||Comparison of Tmax of amiloride for test and reference product has been presented.|||105.23|97.84|
70952153|NCT01254552|141405524|OTHER||rate|0.071|||||TWO_SIDED|95.0|0.043|0.1||||||||0.100|0.043|
70952154|NCT02579135|141405527|SUPERIORITY|Before the onset of the study, we conducted a power calculation to determine the appropriate sample size. We designed the study to have 80% power at a .05 significance level to detect differences in primary outcomes, assuming an effect size of 0.5 and a correlation of 0.4 between assessments. Final enrollment (n= 222) exceeded our target sample size (n= 150).|beta|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.32|TWO_SIDED||||||Regression, Linear|||Third, to assess the effectiveness of the HEART intervention from pretest to immediate posttest, we used linear regression analyses to compute adjusted means and mean differences between intervention and control groups. We included an indicator for school to adjust for clustering by school. For each outcome, the corresponding pretest measure was included as a covariate.||||.32
70869401|NCT01980940|141224308|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5507|||||||Jonckheere-Terpstra test|||Treatment comparison of Day 7 PGART frequencies (ETOR 50 DMSO vs Placebo \[Pt 2\]) was performed using a two-sided Jonckheere-Terpstra test.||||0.5507
70869402|NCT01980940|141224308|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3992|||||||Jonckheere-Terpstra test|||Treatment comparison of Day 11 PGART frequencies (ETOR 50 DMSO vs Placebo \[Pt 2\]) was performed using a two-sided Jonckheere-Terpstra test.||||0.3992
70869403|NCT01980940|141224308|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6626|||||||Jonckheere-Terpstra test|||Treatment comparison of Day 14 PGART frequencies (ETOR 50 DMSO vs Placebo \[Pt 2\]) was performed using a two-sided Jonckheere-Terpstra test.||||0.6626
70869404|NCT01980940|141224308|SUPERIORITY_OR_OTHER_LEGACY|||||||0.315|||||||Jonckheere-Terpstra test|||Treatment comparison of post-trial PGART frequencies (ETOR 50 DMSO vs Placebo \[Pt 2\]) was performed using a two-sided Jonckheere-Terpstra test.||||0.3150
70869405|NCT01637935|141224320|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.1||||||95.0|0.92|1.31||||||Fully adjusted refers to inclusion of all potential confounders in the statistical model from the 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder cancer, renal insufficiency, HbA1c and the interaction with new diagnosis of diabetes, duration of diabetes, and year of cohort entry.||1.31|0.92|
70869406|NCT01637935|141224320|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.06||||||95.0|0.89|1.26||||||Fully adjusted adding the proteinuria testing variable.||1.26|0.89|
70869407|NCT01637935|141224321|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||||95.0|0.71|1.12||||||Time since starting pioglitazone \<4.5 years vs unexposed group. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.12|0.71|
70869408|NCT01637935|141224321|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||||95.0|0.93|1.59||||||Time since starting pioglitazone 4.5-8 years vs unexposed group. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.59|0.93|
70869409|NCT01637935|141224321|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||||95.0|0.83|1.75||||||Time since starting pioglitazone \>8 years vs unexposed group. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.75|0.83|
70952155|NCT02579135|141405528|SUPERIORITY|Before the onset of the study, we conducted a power calculation to determine the appropriate sample size. We designed the study to have 80% power at a .05 significance level to detect differences in primary outcomes, assuming an effect size of 0.5 and a correlation of 0.4 between assessments. Final enrollment (n= 222) exceeded our target sample size (n= 150).|beta|8.31|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED||||||Regression, Linear|||We used linear regression analyses to compute adjusted means and mean differences between intervention and control groups. We included an indicator for school to adjust for clustering by school. For each outcome, the corresponding pretest measure was included as a covariate.||||<.001
70869410|NCT01637935|141224322|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||||95.0|0.68|1.16||||||Duration of therapy \<1.5 years. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.16|0.68|
70869411|NCT01637935|141224322|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||||95.0|0.8|1.33||||||Duration of therapy 1.5-4 years. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.33|0.80|
70952156|NCT01146600|141405529|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||ANOVA|ANOVA, comparing baseline, clarithromycin, and placebo||||||0.47
70869412|NCT01637935|141224322|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||||95.0|0.87|1.54||||||Duration of therapy \>4 years. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.54|0.87|
70869413|NCT01637935|141224323|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||||95.0|0.69|1.16||||||Cumulative dose 1-14000 mg. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.16|0.69|
70952157|NCT01146600|141405530|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo||||||0.63
70952158|NCT01146600|141405531|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo||||||0.64
70952159|NCT01146600|141405532|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo||||||0.002
70952160|NCT01146600|141405533|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo||||||0.002
70952161|NCT01146600|141405534|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo||||||0.01
70952162|NCT01146600|141405535|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo||||||0.76
70952163|NCT03596762|141405539|SUPERIORITY||Difference in LS means|-1.52|||=|0.1946|TWO_SIDED|95.0|-3.83|0.78|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||0.78|-3.83|= 0.1946
70869414|NCT01637935|141224323|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||||95.0|0.85|1.42||||||Cumulative dose 14001-40000 mg. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.42|0.85|
70869415|NCT01637935|141224323|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||||95.0|0.79|1.44||||||Cumulative dose \>40000 mg. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.44|0.79|
70869416|NCT00709761|141224326|SUPERIORITY_OR_OTHER||percentage of participants|53.0||||||95.0|40.7|66.0|||||The estimation parameter represents the percentage of participants experiencing either a CR or a PR.|||66.0|40.7|
70869417|NCT03311724|141224333|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.5|-1.4|||Mixed Models Analysis|||||-1.4|-2.5|<0.001
70869418|NCT03311724|141224333|SUPERIORITY||Mean Difference (Final Values)|-2.2|||<|0.001|TWO_SIDED|95.0|-2.8|-1.7|||Mixed Models Analysis|||||-1.7|-2.8|<0.001
70869419|NCT03311724|141224333|SUPERIORITY||Mean Difference (Final Values)|-2.0|||<|0.001|TWO_SIDED|95.0|-2.5|-1.4|||Mixed Models Analysis|||||-1.4|-2.5|<0.001
71143952|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.228|||<|0.0001|TWO_SIDED|95.0|0.687|1.769|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.769|0.687|<.0001
71143953|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.229|||<|0.0001|TWO_SIDED|95.0|0.673|1.785|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.785|0.673|<.0001
70869420|NCT03311724|141224334|SUPERIORITY||Odds Ratio (OR)|56.54|||<|0.001|TWO_SIDED|95.0|9.43|338.97|||Regression, Logistic|||||338.97|9.43|<0.001
70869421|NCT03311724|141224334|SUPERIORITY||Odds Ratio (OR)|183.48|||<|0.001|TWO_SIDED|95.0|22.0|999.0|||Regression, Logistic||"Maximum confidential interval is \>999"|||999|22.0|<0.001
70869422|NCT03311724|141224334|SUPERIORITY||Odds Ratio (OR)|157.54|||<|0.001|TWO_SIDED|95.0|21.63|999.0|||Regression, Logistic||"Maximum confidential interval is \>999"|||999|21.63|<0.001
70869423|NCT03311724|141224335|SUPERIORITY||Mean Difference (Final Values)|-48.5|||<|0.001|TWO_SIDED|95.0|-70.6|-26.3|||Mixed Models Analysis|||||-26.3|-70.6|<0.001
70869424|NCT03311724|141224335|SUPERIORITY||Mean Difference (Final Values)|-58.0|||<|0.001|TWO_SIDED|95.0|-80.7|-35.2|||Mixed Models Analysis|||||-35.2|-80.7|<0.001
70869425|NCT03311724|141224335|SUPERIORITY||Mean Difference (Final Values)|-61.9|||<|0.001|TWO_SIDED|95.0|-84.6|-39.2|||Mixed Models Analysis|||||-39.2|-84.6|<0.001
70869426|NCT03311724|141224336|SUPERIORITY||Mean Difference (Final Values)|-4.8|||<|0.001|TWO_SIDED|95.0|-7.1|-2.6|||Mixed Models Analysis|||||-2.6|-7.1|<0.001
70869427|NCT03311724|141224336|SUPERIORITY||Mean Difference (Final Values)|-5.0|||<|0.001|TWO_SIDED|95.0|-7.2|-2.7|||Mixed Models Analysis|||||-2.7|-7.2|<0.001
70869428|NCT03311724|141224336|SUPERIORITY||Mean Difference (Final Values)|-5.2|||<|0.001|TWO_SIDED|95.0|-7.5|-2.9|||Mixed Models Analysis|||||-2.9|-7.5|<0.001
70869429|NCT03311724|141224337|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.075|TWO_SIDED|95.0|-4.7|0.2|||Mixed Models Analysis|||||0.2|-4.7|0.075
70869430|NCT03311724|141224337|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.065|TWO_SIDED|95.0|-4.9|0.1|||Mixed Models Analysis|||||0.1|-4.9|0.065
70869431|NCT03311724|141224337|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.065|TWO_SIDED|95.0|-4.9|0.2|||Mixed Models Analysis|||||0.2|-4.9|0.065
70869432|NCT00844831|141224401|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||||||0.75
70869433|NCT00844831|141224403|OTHER|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||.9
70869434|NCT02957305|141224404|NON_INFERIORITY|400µg of misoprostol yields a 96% cervical dilation \> 8 mm. We considered 86% of the 200 µg misoprostol group as the minimal acceptable percentage. The non-inferiority margin was determined by 24.46.|treatment difference|25.0||||0.025|ONE_SIDED|95.0||97.5||The null hypothesis: percentage of dilation with 400µg ≥ percentage of dilation with 200µg + 25% Alternative hypothesis: percentage of dilation with 400µg - 25% \< percentage of dilation with 200µg|difference between proportions|difference between percentages and 95% confidence interval||If there is a true difference in favour of the standard treatment of 10% (96% vs 86%), then 184 patients are required to be 95% sure that the upper limit of a one-sided 97.5% confidence interval (or equivalently a 95% two-sided confidence interval) will exclude a difference in favour of the standard group of more than 25%||97.5||0.025
70952164|NCT03596762|141405539|SUPERIORITY||Difference in LS means|1.29|||=|0.3682|TWO_SIDED|95.0|-4.11|1.53|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||1.53|-4.11|= 0.3682
70952165|NCT03596762|141405539|SUPERIORITY||Difference in LS means|-3.93|||=|0.0002|TWO_SIDED|95.0|-5.94|-1.92|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||-1.92|-5.94|= 0.0002
71143954|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.232|||<|0.0001|TWO_SIDED|95.0|0.646|1.818|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.818|0.646|<.0001
71143955|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.233|||<|0.0001|TWO_SIDED|95.0|0.629|1.838|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.838|0.629|<.0001
70869435|NCT02957305|141224404|NON_INFERIORITY|The non-inferiority margin was determined by ⅓ of the difference between the 400µg effect (96.7%), compared to the 200 µg dose (23.3%), i.e. 73.4 / 3 = 24.46%|Difference between proportions|0.1146||||0.004|TWO_SIDED|95.0|0.037|0.192|||Chi-squared||The difference between both groups was 11.5% (95%CI = 3.7% to 19.2%)|||0.192|0.037|0.004
70869436|NCT02957305|141224406|SUPERIORITY||Median Difference (Final Values)|0.0||||0.9|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.9
70952166|NCT03596762|141405539|SUPERIORITY||Difference in LS means|-2.63|||=|0.0115|TWO_SIDED|95.0|-4.66|-0.6|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||-0.6|-4.66|= 0.0115
70952167|NCT03596762|141405540|SUPERIORITY||Difference in LS means|-1.67|||=|0.2097|TWO_SIDED|95.0|-4.28|-0.95|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||-0.95|-4.28|= 0.2097
70952168|NCT03596762|141405540|SUPERIORITY||Difference in LS means|-0.77|||=|0.6369|TWO_SIDED|95.0|-3.97|2.44|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||2.44|-3.97|= 0.6369
71143956|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.236||||0.0002|TWO_SIDED|95.0|0.595|1.876|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.876|0.595|0.0002
71143957|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.237||||0.0003|TWO_SIDED|95.0|0.575|1.899|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.899|0.575|0.0003
71143958|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24||||0.0005|TWO_SIDED|95.0|0.537|1.942|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.942|0.537|0.0005
71143959|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.241||||0.0008|TWO_SIDED|95.0|0.515|1.967|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.967|0.515|0.0008
71143960|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.244||||0.0015|TWO_SIDED|95.0|0.474|2.013|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.013|0.474|0.0015
71143961|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.245||||0.0021|TWO_SIDED|95.0|0.45|2.04|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.040|0.450|0.0021
71143962|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.248||||0.0037|TWO_SIDED|95.0|0.406|2.089|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.089|0.406|0.0037
71143963|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.249||||0.0048|TWO_SIDED|95.0|0.382|2.116|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.116|0.382|0.0048
71143964|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.251||||0.0074|TWO_SIDED|95.0|0.336|2.167|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.167|0.336|0.0074
71143965|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.253||||0.0092|TWO_SIDED|95.0|0.31|2.196|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.196|0.310|0.0092
70869437|NCT03486223|141224442|SUPERIORITY|||||||0.71||||||Wilcoxon signed-rank test was used for the within-subject comparison of GSK2256294 versus placebo.|Wilcoxon (Mann-Whitney)|||A sample size of 16 per group was estimated to have 86% power to detect a within-subject difference of 3.76 (80% of the above difference) or larger (with an SD for the within-subject difference of 4.6) in insulin sensitivity.||||0.71
70869438|NCT01758432|141224459|SUPERIORITY||Least Squares Means (Difference)|-95.74|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
70869439|NCT01758432|141224459|SUPERIORITY||Least Squares Means (Difference)|-130.5|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
70869440|NCT01758432|141224459|SUPERIORITY||Least Squares Means (Difference)|-129.86|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
70952169|NCT03596762|141405540|SUPERIORITY||Difference in LS means|-2.95|||=|0.0116|TWO_SIDED|95.0|-5.22|-0.67|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||-0.67|-5.22|= 0.0116
71143966|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.255||||0.0132|TWO_SIDED|95.0|0.262|2.248|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.248|0.262|0.0132
71143967|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.257||||0.0159|TWO_SIDED|95.0|0.236|2.278|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.278|0.236|0.0159
71143968|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.259||||0.0213|TWO_SIDED|95.0|0.187|2.332|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.332|0.187|0.0213
71143969|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.261||||0.0248|TWO_SIDED|95.0|0.16|2.362|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.362|0.160|0.0248
71143970|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.263||||0.0318|TWO_SIDED|95.0|0.11|2.416|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.416|0.110|0.0318
71143971|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.265||||0.036|TWO_SIDED|95.0|0.083|2.447|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.447|0.083|0.0360
71143972|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.267||||0.0443|TWO_SIDED|95.0|0.032|2.502|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.502|0.032|0.0443
71143973|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.269||||0.0493|TWO_SIDED|95.0|0.004|2.533|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.533|0.004|0.0493
71143974|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.271||||0.0587|TWO_SIDED|95.0|-0.047|2.589|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.589|-0.047|0.0587
70869441|NCT01758432|141224459|SUPERIORITY||Least Squares Means (Difference)|-165.91|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
70869442|NCT01758432|141224459|SUPERIORITY||Least Squares Means (Difference)|-167.94|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
70869443|NCT01758432|141224459|SUPERIORITY||Least Squares Means (Difference)|-135.91|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
70869444|NCT01758432|141224460|SUPERIORITY||Least Squares Means (Difference)|85559.49||||0.0004|TWO_SIDED|95.0|||||ANCOVA|||||||0.0004
70869445|NCT01758432|141224460|SUPERIORITY||Least Squares Means (Difference)|105508.3|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
70869446|NCT01758432|141224460|SUPERIORITY||Least Squares Means (Difference)|182753.2|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
70869447|NCT01758432|141224460|SUPERIORITY||Least Squares Means (Difference)|193684.5|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
70869448|NCT01758432|141224460|SUPERIORITY||Least Squares Means (Difference)|178055.0|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
70869449|NCT01758432|141224460|SUPERIORITY||Least Squares Means (Difference)|169709.9|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
70869450|NCT01758432|141224461|SUPERIORITY||Least Squares Means (Difference)|-4.58|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
70952170|NCT03596762|141405540|SUPERIORITY||Difference in LS means|-1.78|||=|0.1346|TWO_SIDED|95.0|-4.12|0.56|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||0.56|-4.12|= 0.1346
70952171|NCT03596762|141405541|SUPERIORITY||Difference in LS means|-0.05|||=|0.7033|TWO_SIDED|95.0|-0.3|0.2|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||0.2|-0.3|= 0.7033
71143975|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.273||||0.0642|TWO_SIDED|95.0|-0.075|2.62|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.620|-0.075|0.0642
70869451|NCT01758432|141224461|SUPERIORITY||Least Squares Means (Difference)|-4.29|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
70869452|NCT01758432|141224461|SUPERIORITY||Least Squares Means (Difference)|-6.15|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
70869453|NCT01758432|141224461|SUPERIORITY||Least Squares Means (Difference)|-6.79|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
70869454|NCT01758432|141224461|SUPERIORITY||Least Squares Means (Difference)|-7.49|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
71143976|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.275||||0.0746|TWO_SIDED|95.0|-0.127|2.677|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.677|-0.127|0.0746
71143977|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.276||||0.0806|TWO_SIDED|95.0|-0.155|2.708|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.708|-0.155|0.0806
71143978|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.279||||0.0917|TWO_SIDED|95.0|-0.207|2.765|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.765|-0.207|0.0917
71143979|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.28||||0.098|TWO_SIDED|95.0|-0.236|2.797|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.797|-0.236|0.0980
71143980|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.283||||0.1095|TWO_SIDED|95.0|-0.288|2.854|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.854|-0.288|0.1095
71143981|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.284||||0.1161|TWO_SIDED|95.0|-0.318|2.886|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.886|-0.318|0.1161
71143982|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.287||||0.128|TWO_SIDED|95.0|-0.37|2.944|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.944|-0.370|0.1280
70869455|NCT01758432|141224461|SUPERIORITY||Least Squares Means (Difference)|-6.71|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
70869456|NCT02417831|141224473|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence range of 80% to 125%.|Ratio|105.76|STANDARD_DEVIATION|14.18|||TWO_SIDED|90.0|99.81|112.08|||||The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation. Ratio calculated as test divided by reference.|||112.08|99.81|
70869457|NCT02417831|141224474|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence range of 80% to 125%.|Ratio|101.4|STANDARD_DEVIATION|9.05|||TWO_SIDED|90.0|97.71|105.23|||||The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation. Ratio calculated as test divided by reference.|||105.23|97.71|
71143983|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.288||||0.1346|TWO_SIDED|95.0|-0.399|2.976|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.976|-0.399|0.1346
71143984|NCT00083889|141781654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.291||||0.1466|TWO_SIDED|95.0|-0.452|3.034|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||3.034|-0.452|0.1466
71143985|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.929||||0.0001|TWO_SIDED|95.0|0.46|1.398|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) Emotional Well Being (EWB) subscale baseline score (intercept and time since randomization are included as random effects).||1.398|0.460|0.0001
71143986|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.922|||<|0.0001||95.0|0.469|1.375|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.375|0.469|<.0001
71143987|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.918|||<|0.0001||95.0|0.471|1.365|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.365|0.471|<.0001
71143988|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.911|||<|0.0001||95.0|0.469|1.352|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.352|0.469|<.0001
71143989|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.907|||<|0.0001||95.0|0.466|1.348|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.348|0.466|<.0001
71143990|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.899|||<|0.0001||95.0|0.453|1.345|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.345|0.453|<.0001
71143991|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.895||||0.0001||95.0|0.444|1.347|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.347|0.444|0.0001
71143992|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.888||||0.0002||95.0|0.421|1.355|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.355|0.421|0.0002
71143993|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.884||||0.0003||95.0|0.406|1.362|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.362|0.406|0.0003
71143994|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.877||||0.0006||95.0|0.375|1.379|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.379|0.375|0.0006
71143995|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.873||||0.0009||95.0|0.356|1.39|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.390|0.356|0.0009
71143996|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.866||||0.002||95.0|0.318|1.414|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.414|0.318|0.0020
70869458|NCT02417831|141224475|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence range of 80% to 125%.|Ratio|101.42|STANDARD_DEVIATION|8.85|||TWO_SIDED|90.0|97.81|105.17|||||The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation. Ratio calculated as test divided by reference.|||105.17|97.81|
70869459|NCT01144286|141224479|SUPERIORITY_OR_OTHER||response rate (%)|80.0||||0.063|TWO_SIDED|95.0||||Significance level was set to α of 0.05 if the primary endpoint was significant, hierarchical testing was to be performed on the primary endpoint (each active dose X placebo). No other adjustment was made for testing multiple secondary outcomes.|Regression, Logistic|||"Primary analysis is the dose response at TOC based on the global therapeutic cure. Dose response will be tested using a logistic regression using linear coefficient for the treatment effect(Wald chi-square).~Assuming that the response rate is 80% for 600 mg, 75% for the 300 mg, 65% for 150 mg and 50% for the placebo group, a sample size of 45 subjects in each group will have 90% power to detect a linear dose response using a 0.05 two-sided test of trend based on the logistic model."||||0.0630
70869460|NCT03130257|141224482|EQUIVALENCE|The study planned for a sample size of 510 and 80% protocol completion, resulting in sample size 136 per group. With this sample size, the least detectable difference (LDD) is 4.1 mmHg systolic BP (SBP) and 2.8 mmHg diastolic BP (DBP) between any two groups (assuming Standard Deviation 12.1 and 8.3 for SBP and DBP respectively). Actual sample sizes completing protocol were 142, 149, and 111 for Clinic, Home, and Kiosk groups respectively, resulting in LDD of at least 4.3 for SBP and 3.0 for DBP.|||||<|0.05|||||||Regression, Linear|||We used linear regression models to estimate the mean difference in BP between diagnostic measurement and daytime average 24-hr BP for each randomization group. Models were estimated using generalized estimating equations with robust standard errors, and adjusted for age, sex, BMI, education, and baseline systolic and diastolic BP. Separate models estimated mean differences (diagnostic protocol - 24-hr BP) between groups for systolic and diastolic BP.||||<0.05
70869461|NCT04377620|141224490|SUPERIORITY||Odds Ratio (OR)|0.46||||0.0292|TWO_SIDED|95.0|0.201|1.028|||Mixed Models Analysis|logistic regression mixed model includes treatment group and ARDS severity as fixed covariates and investigational site as a random effect.||||1.028|0.201|0.0292
70869462|NCT04377620|141224490|SUPERIORITY||Odds Ratio (OR)|0.42||||0.028|TWO_SIDED|95.0|0.171|1.023|||Mixed Models Analysis|logistic regression mixed model includes treatment group and ARDS severity as fixed covariates and investigational site as a random effect.||||1.023|0.171|0.0280
70869463|NCT00332163|141224525|SUPERIORITY_OR_OTHER||Difference|-33.0|||||TWO_SIDED|95.0|-51.0|-14.0|||||Difference = Pre-emptive - Reactive|||-14|-51|
70869464|NCT00332163|141224526|SUPERIORITY_OR_OTHER||Difference|-22.0|||||TWO_SIDED|95.0|-42.0|-3.0|||||Difference = Pre-emptive - Reactive|||-3|-42|
70869465|NCT00332163|141224527|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.2|0.7|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with an indicator for treatment (pre-emptive vs. reactive), stratified by chemotherapy stratum (Q2W vs Q3W).|||0.7|0.2|
70869466|NCT00332163|141224529|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.2|0.7|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with an indicator for treatment (Pre-emptive vs. Reactive) stratified by chemotherapy stratum (Q2W vs Q3W).|||0.7|0.2|
70869467|NCT00332163|141224530|SUPERIORITY_OR_OTHER||Difference|-4.0|||||TWO_SIDED|95.0|-16.0|7.0|||||Difference = Pre-emptive - Reactive|||7|-16|
70869468|NCT00332163|141224531|SUPERIORITY_OR_OTHER||Difference|0.0|||||TWO_SIDED|95.0|-10.0|10.0|||||Difference = Pre-emptive - Reactive|||10|-10|
70869469|NCT00332163|141224532|SUPERIORITY_OR_OTHER||Difference|4.0|||||TWO_SIDED|95.0|-9.0|17.0|||||Rate difference = Pre-emptive - Reactive|||17|-9|
70869470|NCT00332163|141224533|SUPERIORITY_OR_OTHER||Difference|-1.0|||||TWO_SIDED|95.0|-21.0|18.0|||||Rate difference = Pre-emptive - Reactive|||18|-21|
70869471|NCT00332163|141224534|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.9|2.0|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with an indicator for treatment (Pre-emptive vs. Reactive) stratified by chemotherapy stratum (Q2W vs Q3W).|||2.0|0.9|
70869472|NCT00332163|141224535|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.6|1.5|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with an indicator for treatment (Pre-emptive vs. Reactive) stratified by chemotherapy stratum (Q2W vs Q3W).|||1.5|0.6|
70869473|NCT00332163|141224536|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.7|2.1|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with an indicator for treatment (Pre-emptive vs. Reactive) stratified by chemotherapy stratum (Q2W vs Q3W).|||2.1|0.7|
70869474|NCT00332163|141224537|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.6|1.6|||||Hazard ratio is estimated from a Cox Proportional Hazards regression model with an indicator for treatment (Pre-emptive vs. Reactive) stratified by chemotherapy stratum (Q2W vs Q3W).|||1.6|0.6|
70869475|NCT02621060|141224539|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.05|STANDARD_DEVIATION|2.0||0.004|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.004
70869476|NCT02621060|141224540|SUPERIORITY_OR_OTHER|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||||||0.084
70869477|NCT02621060|141224541|SUPERIORITY_OR_OTHER|||||||0.755|||||||Wilcoxon (Mann-Whitney)|||||||0.755
70869478|NCT02621060|141224542|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
70869479|NCT02621060|141224543|SUPERIORITY_OR_OTHER|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||||||0.084
70869480|NCT02621060|141224544|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
70869481|NCT02621060|141224546|SUPERIORITY_OR_OTHER|||||||0.074|||||||Wilcoxon (Mann-Whitney)|||||||0.074
70869482|NCT02621060|141224547|SUPERIORITY_OR_OTHER|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||||||0.022
70869483|NCT02621060|141224548|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.022|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.022
70869484|NCT02621060|141224549|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.022|TWO_SIDED|5.0|||||Wilcoxon (Mann-Whitney)|||||||0.022
70869485|NCT02621060|141224550|SUPERIORITY_OR_OTHER|||||||0.594|||||||Wilcoxon (Mann-Whitney)|||||||0.594
70869486|NCT02621060|141224551|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
70869487|NCT02621060|141224552|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
70869488|NCT02621060|141224553|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
70869489|NCT02621060|141224554|SUPERIORITY_OR_OTHER|||||||0.059|||||||Wilcoxon (Mann-Whitney)|||||||0.059
70869490|NCT02621060|141224555|SUPERIORITY_OR_OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|||||||0.049
70869491|NCT02621060|141224556|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
70952172|NCT03596762|141405541|SUPERIORITY||Difference in LS means|-0.14|||=|0.3724|TWO_SIDED|95.0|-0.45|0.17|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||0.17|-0.45|= 0.3724
71143997|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.862||||0.0029||95.0|0.295|1.428|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.428|0.295|0.0029
71143998|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.854||||0.0055||95.0|0.251|1.457|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.457|0.251|0.0055
71143999|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.0076||95.0|0.226|1.475|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.475|0.226|0.0076
71144000|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.843||||0.0129||95.0|0.179|1.508|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.508|0.179|0.0129
71144001|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.839||||0.0168||95.0|0.151|1.527|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.527|0.151|0.0168
71144002|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.832||||0.0257||95.0|0.101|1.563|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.563|0.101|0.0257
71144003|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.828||||0.0318||95.0|0.072|1.583|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.583|0.072|0.0318
71144004|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.821||||0.0447||95.0|0.019|1.622|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.622|0.019|0.0447
71144005|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.817||||0.0529||95.0|-0.01|1.643|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.643|-0.010|0.0529
71144006|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.809||||0.0696||95.0|-0.065|1.683|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.683|-0.065|0.0696
71144007|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.805||||0.0797||95.0|-0.095|1.706|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.706|-0.095|0.0797
71144008|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.798||||0.0994||95.0|-0.151|1.747|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.747|-0.151|0.0994
70869492|NCT02621060|141224557|SUPERIORITY_OR_OTHER|||||||0.376|||||||Wilcoxon (Mann-Whitney)|||||||0.376
70869493|NCT02621060|141224558|SUPERIORITY_OR_OTHER|||||||0.472|||||||Wilcoxon (Mann-Whitney)|||||||0.472
70869494|NCT02621060|141224559|SUPERIORITY_OR_OTHER|||||||0.774|||||||Wilcoxon (Mann-Whitney)|||||||0.774
70952173|NCT03596762|141405541|SUPERIORITY||Difference in LS means|-0.19|||=|0.0896|TWO_SIDED|95.0|-0.41|0.03|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||0.03|-0.41|= 0.0896
70952174|NCT03596762|141405541|SUPERIORITY||Difference in LS means|-0.19|||=|0.09|TWO_SIDED|95.0|-0.41|0.03|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||0.03|-0.41|= 0.09
70869495|NCT02621060|141224560|SUPERIORITY_OR_OTHER|||||||0.637|||||||Wilcoxon (Mann-Whitney)|||||||0.637
70869496|NCT03733470|141224561|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70869497|NCT01010061|141224562|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.16|0.28||Type I error controlled through closed test procedure.|Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.28|0.16|<0.0001
70869498|NCT01010061|141224564|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.19|||<|0.0001|TWO_SIDED|95.0|0.14|0.27|||Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.27|0.14|<0.0001
70869499|NCT01010061|141224567|SUPERIORITY||Difference in Response Rates|45.1|||<|0.0001|TWO_SIDED|95.0|34.7|55.5|||Chi-squared|||Includes subjects with best overall response: CR, CRi, PR or nPR.||55.5|34.7|< 0.0001
70869500|NCT01010061|141224568|SUPERIORITY||Hazard Ratio (HR)|0.19|||<|0.0001|TWO_SIDED|95.0|0.15|0.26|||Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.26|0.15|<0.0001
71144009|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.794||||0.111||95.0|-0.182|1.77|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.770|-0.182|0.1110
71144010|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.787||||0.1328||95.0|-0.239|1.813|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.813|-0.239|0.1328
71144011|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.783||||0.1454||95.0|-0.271|1.836|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.836|-0.271|0.1454
70869501|NCT01010061|141224569|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0196|TWO_SIDED|95.0|0.49|0.94|||Log Rank, Stratified|||||0.94|0.49|0.0196
70869502|NCT01010061|141224570|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.19|||<|0.0001|TWO_SIDED|95.0|0.13|0.28|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.28|0.13|<0.0001
70869503|NCT01010061|141224572|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.25|||<|0.0001|TWO_SIDED|95.0|0.19|0.35|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.35|0.19|<0.0001
70869504|NCT00864383|141224582|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was defined as a between-group difference of less than 6 percentage points in the upper boundary of the two-sided 97.5% Wald confidence interval for the difference in proportion of patients with an unfavorable outcome.|Adjusted difference in proportions|6.1|||||TWO_SIDED|97.5|1.7|10.5|||||Adjusted difference from control in proportion of unfavorable outcome - percentage points|||10.5|1.7|
70869505|NCT00864383|141224582|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was defined as a between-group difference of less than 6 percentage points in the upper boundary of the two-sided 97.5% Wald confidence interval for the proportion of patients with an unfavorable outcome.|Adjusted difference from control|11.4|||||TWO_SIDED|97.5|6.7|16.1|||||Adjusted difference from control in rate of unfavorable outcome- percentage points|||16.1|6.7|
70869506|NCT02021773|141224619|SUPERIORITY||Mean Difference (Final Values)|-22.74|STANDARD_ERROR_OF_MEAN|10.937||0.0386|TWO_SIDED|95.0|-44.28|-1.21||The threshold for statistical significance was p = .05.|Mixed Models Analysis|||||-1.21|-44.28|0.0386
70869507|NCT02021773|141224619|SUPERIORITY||Mean Difference (Final Values)|-30.41|STANDARD_ERROR_OF_MEAN|10.9||0.0057|TWO_SIDED|95.0|-51.88|-8.95||The threshold for statistical significance was p = .05.|Mixed Models Analysis|||||-8.95|-51.88|0.0057
70869508|NCT00087607|141224629|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.978|TWO_SIDED|95.0|-0.35|0.36|||t-test, 2 sided|||Mean treatment difference was tested using a two-sided t-test.||0.36|-0.35|0.978
70869509|NCT00087607|141224630|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27||||0.08|TWO_SIDED|95.0|-0.03|0.58|||t-test, 2 sided|||At Week 4: Mean treatment difference was tested using a two-sided t-test.||0.58|-0.03|0.080
70869510|NCT00087607|141224630|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.688|TWO_SIDED|95.0|-0.27|0.41|||t-test, 2 sided|||At Week 8: Mean treatment difference was tested using a two-sided t-test.||0.41|-0.27|0.688
70869511|NCT00087607|141224634|SUPERIORITY_OR_OTHER|||||||0.304|TWO_SIDED||||||ANOVA|||The treatment groups were compared using an analysis of variance (ANOVA) with treatment as the only factor in the model.||||0.304
70869512|NCT00087607|141224636|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-3.1||||0.2814|TWO_SIDED|95.0|-8.6|2.5|||Chi-squared|||Week 1: Treatment groups were compared using the Chi-Square Test.||2.5|-8.6|0.2814
70869513|NCT00087607|141224636|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-10.3||||0.0214|TWO_SIDED|95.0|-18.9|-1.6|||Chi-squared|||Week 2: Treatment groups were compared using the Chi-Square Test.||-1.6|-18.9|0.0214
70869514|NCT00087607|141224636|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-10.7||||0.0315|TWO_SIDED|95.0|-20.3|-1.0|||Chi-squared|||Week 3: Treatment groups were compared using the Chi-Square Test.||-1.0|-20.3|0.0315
70869515|NCT00087607|141224636|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-7.4||||0.1467|TWO_SIDED|95.0|-17.4|2.6|||Chi-squared|||Week 4: Treatment groups were compared using the Chi-Square Test.||2.6|-17.4|0.1467
70869516|NCT00087607|141224636|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-6.8||||0.1823|TWO_SIDED|95.0|-16.9|3.2|||Chi-squared|||Week 5: Treatment groups were compared using the Chi-Square Test.||3.2|-16.9|0.1823
70869517|NCT00087607|141224636|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-2.1||||0.6871|TWO_SIDED|95.0|-12.1|8.0|||Chi-squared|||Week 6: Treatment groups were compared using the Chi-Square Test.||8.0|-12.1|0.6871
70869518|NCT00087607|141224636|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-0.4||||0.9295|TWO_SIDED|95.0|-10.4|9.5|||Chi-squared|||Week 7: Treatment groups were compared using the Chi-Square Test.||9.5|-10.4|0.9295
70869519|NCT00087607|141224636|SUPERIORITY_OR_OTHER||Difference in proportion of participants|2.2||||0.6593|TWO_SIDED|95.0|-7.6|12.1|||Chi-squared|||Week 8: Treatment groups were compared using the Chi-Square Test.||12.1|-7.6|0.6593
70869520|NCT00087607|141224636|SUPERIORITY_OR_OTHER||Difference in proportion of participants|2.2||||0.6637|TWO_SIDED|95.0|-7.7|12.1|||Chi-squared|||Week 9: Treatment groups were compared using the Chi-Square Test.||12.1|-7.7|0.6637
70869521|NCT00087607|141224636|SUPERIORITY_OR_OTHER||Difference in proportion of participants|5.4||||0.276|TWO_SIDED|95.0|-4.3|15.1|||Chi-squared|||Week 10: Treatment groups were compared using the Chi-Square Test.||15.1|-4.3|0.2760
70869522|NCT00087607|141224636|SUPERIORITY_OR_OTHER||Difference in proportion of participants|5.4||||0.2779|TWO_SIDED|95.0|-4.3|15.1|||Chi-squared|||Week 11: Treatment groups were compared using the Chi-Square Test.||15.1|-4.3|0.2779
70869523|NCT00087607|141224636|SUPERIORITY_OR_OTHER||Difference in proportion of participants|2.8||||0.5697|TWO_SIDED|95.0|-6.8|12.4|||Chi-squared|||Week 12: Treatment groups were compared using the Chi-Square Test.||12.4|-6.8|0.5697
70869524|NCT00087607|141224637|SUPERIORITY_OR_OTHER||Difference in proportion of participants|0.0||||0.994|TWO_SIDED|95.0|-1.4|1.5|||Chi-squared|||Week 1: Treatment groups were compared using the Chi-Square Test.||1.5|-1.4|0.9940
70869525|NCT00087607|141224637|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-0.5||||0.7133|TWO_SIDED|95.0|-3.2|2.2|||Chi-squared|||Week 2: Treatment groups were compared using the Chi-Square Test.||2.2|-3.2|0.7133
70869526|NCT00087607|141224637|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-3.6||||0.0864|TWO_SIDED|95.0|-7.8|0.5|||Chi-squared|||Week 3: Treatment groups were compared using the Chi-Square Test.||0.5|-7.8|0.0864
70869527|NCT00087607|141224637|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-4.1||||0.1713|TWO_SIDED|95.0|-10.0|1.8|||Chi-squared|||Week 4: Treatment groups were compared using the Chi-Square Test.||1.8|-10.0|0.1713
70869528|NCT00087607|141224637|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-4.6||||0.1888|TWO_SIDED|95.0|-11.4|2.2|||Chi-squared|||Week 5: Treatment groups were compared using the Chi-Square Test.||2.2|-11.4|0.1888
70869529|NCT00087607|141224637|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-6.6||||0.108|TWO_SIDED|95.0|-14.7|1.4|||Chi-squared|||Week 6: Treatment groups were compared using the Chi-Square Test.||1.4|-14.7|0.1080
70869530|NCT00087607|141224637|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-4.5||||0.3099|TWO_SIDED|95.0|-13.1|4.2|||Chi-squared|||Week 7: Treatment groups were compared using the Chi-Square Test.||4.2|-13.1|0.3099
70869531|NCT00087607|141224637|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-3.4||||0.4595|TWO_SIDED|95.0|-12.4|5.6|||Chi-squared|||Week 8: Treatment groups were compared using the Chi-Square Test.||5.6|-12.4|0.4595
70869532|NCT00087607|141224637|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-6.0||||0.2144|TWO_SIDED|95.0|-15.4|3.4|||Chi-squared|||Week 9: Treatment groups were compared using the Chi-Square Test.||3.4|-15.4|0.2144
71144012|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.776||||0.1686||95.0|-0.329|1.88|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.880|-0.329|0.1686
70869533|NCT00087607|141224637|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-5.4||||0.2779|TWO_SIDED|95.0|-15.1|4.3|||Chi-squared|||Week 10: Treatment groups were compared using the Chi-Square Test.||4.3|-15.1|0.2779
70869534|NCT00087607|141224637|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-2.7||||0.5876|TWO_SIDED|95.0|-12.6|7.1|||Chi-squared|||Week 11: Treatment groups were compared using the Chi-Square Test.||7.1|-12.6|0.5876
70869535|NCT00087607|141224637|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-4.8||||0.3399|TWO_SIDED|95.0|-14.7|5.1|||Chi-squared|||Week 12: Treatment groups were compared using the Chi-Square Test.||5.1|-14.7|0.3399
70869536|NCT00087607|141224642|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED||||||Repeated measures analysis|The P-value is determined from a repeated measures analysis with terms for treatment group, baseline, week, and the week-by-treatment interaction.||Week 1: The treatment groups were compared using repeated measures analysis||||0.024
70869537|NCT00087607|141224642|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Repeated measures analysis|||Week 8: The treatment groups were compared using Repeated measures analysis||||<0.001
70869538|NCT02516046|141224724|OTHER||Fleiss' kappa|0.8|||||TWO_SIDED|95.0|0.74|0.86||||||Inter-reader agreement analysis using Fleiss' kappa. The hypothesis tested was that the observed kappa values were ≥0.64 and the lower bound of the 2-sided 95% CIs were ≥0.55 for the inter-reader agreement among readers.||0.86|0.74|
70869539|NCT05248867|141224745|SUPERIORITY||Rate Difference|59.3|||<|0.0001|TWO_SIDED|95.0|54.7|63.9||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||63.9|54.7|<0.0001
70869540|NCT05248867|141224746|SUPERIORITY||Rate Difference|60.2|||<|0.0001|TWO_SIDED|95.0|54.9|65.4||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||65.4|54.9|<0.0001
70869541|NCT05248867|141224747|SUPERIORITY||Rate Difference|71.4|||<|0.0001|TWO_SIDED|95.0|66.5|76.2||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||76.2|66.5|<0.0001
70952175|NCT03596762|141405542|SUPERIORITY||Difference in LS means|-0.09|||=|0.5511|TWO_SIDED|95.0|-0.39|0.21|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||0.21|-0.39|= 0.5511
70869542|NCT05248867|141224752|SUPERIORITY||Rate Difference|72.5|||<|0.0001|TWO_SIDED|95.0|67.4|77.6||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||77.6|67.4|<0.0001
70869543|NCT05248867|141224753|SUPERIORITY||Rate Difference|41.9|||<|0.0001|TWO_SIDED|95.0|34.5|49.3||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||49.3|34.5|<0.0001
70869544|NCT05248867|141224754|SUPERIORITY||Rate Difference|69.5|||<|0.0001|TWO_SIDED|95.0|63.7|75.3||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||75.3|63.7|<0.0001
70869545|NCT05248867|141224755|SUPERIORITY||Rate Difference|58.2|||<|0.0001|TWO_SIDED|95.0|51.3|65.0||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||65.0|51.3|<0.0001
70869546|NCT05248867|141224756|SUPERIORITY||Rate Difference|30.1|||<|0.0001|TWO_SIDED|95.0|25.2|35.1||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||35.1|25.2|<0.0001
70869547|NCT05248867|141224757|SUPERIORITY||Rate Difference|35.7|||<|0.0001|TWO_SIDED|95.0|30.5|40.9||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||40.9|30.5|<0.0001
70869548|NCT05248867|141224758|SUPERIORITY||Rate Difference|52.6|||<|0.0001|TWO_SIDED|95.0|45.2|60.0||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||60.0|45.2|<0.0001
70869549|NCT05248867|141224759|SUPERIORITY||Rate Difference|58.6|||<|0.0001|TWO_SIDED|95.0|51.1|66.1||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||66.1|51.1|<0.0001
70869550|NCT05248867|141224760|SUPERIORITY||Rate Difference|42.5|||<|0.0001|TWO_SIDED|95.0|34.4|50.6||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||50.6|34.4|<0.0001
71144013|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.771||||0.1817||95.0|-0.361|1.904|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.904|-0.361|0.1817
71144014|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.764||||0.2055||95.0|-0.419|1.948|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.948|-0.419|0.2055
71144015|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.76||||0.2188||95.0|-0.452|1.972|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.972|-0.452|0.2188
71144016|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.753||||0.2427||95.0|-0.51|2.016|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.016|-0.510|0.2427
71144017|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.749||||0.2559||95.0|-0.543|2.041|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.041|-0.543|0.2559
71144018|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.742||||0.2794||95.0|-0.602|2.086|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.086|-0.602|0.2794
71144019|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.738||||0.2923||95.0|-0.635|2.111|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.111|-0.635|0.2923
71144020|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73||||0.3152||95.0|-0.695|2.156|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.156|-0.695|0.3152
71144021|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.726||||0.3276||95.0|-0.728|2.181|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.181|-0.728|0.3276
71144022|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.719||||0.3497||95.0|-0.788|2.227|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.227|-0.788|0.3497
71144023|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.715||||0.3616||95.0|-0.822|2.252|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.252|-0.822|0.3616
71144024|NCT00083889|141781655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.708||||0.3827||95.0|-0.882|2.298|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.298|-0.882|0.3827
71144025|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.897|||<|0.0001|TWO_SIDED|95.0|1.261|2.533|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) Functional Well Being (FWB) subscale baseline score (intercept and time since randomization are included as random effects).||2.533|1.261|<.0001
71144026|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.924|||<|0.0001||95.0|1.309|2.539|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.539|1.309|<.0001
71144027|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.939|||<|0.0001||95.0|1.331|2.546|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.546|1.331|<.0001
71144028|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.965|||<|0.0001||95.0|1.363|2.568|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.568|1.363|<.0001
71144029|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.98|||<|0.0001||95.0|1.376|2.584|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.584|1.376|<.0001
71144030|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.007|||<|0.0001||95.0|1.392|2.622|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.622|1.392|<.0001
71144031|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.022|||<|0.0001||95.0|1.396|2.647|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.647|1.396|<.0001
71144032|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.048|||<|0.0001||95.0|1.397|2.7|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.700|1.397|<.0001
71144033|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.063|||<|0.0001||95.0|1.394|2.732|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.732|1.394|<.0001
71144034|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.09|||<|0.0001||95.0|1.383|2.797|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.797|1.383|<.0001
70869551|NCT05248867|141224761|SUPERIORITY||Rate Difference|70.0|||<|0.0001|TWO_SIDED|95.0|63.7|76.3||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||76.3|63.7|<0.0001
70869552|NCT05248867|141224769|SUPERIORITY||Rate Difference|48.8|||<|0.0001|TWO_SIDED|95.0|42.2|55.4||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||55.4|42.2|<0.0001
70952176|NCT03596762|141405542|SUPERIORITY||Difference in LS means|0.16|||=|0.3822|TWO_SIDED|95.0|-0.2|0.52|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||0.52|-0.2|= 0.3822
71144035|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.105|||<|0.0001||95.0|1.374|2.836|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.836|1.374|<.0001
70869553|NCT05248867|141224770|SUPERIORITY||Rate Difference|44.2|||<|0.0001|TWO_SIDED|95.0|38.0|50.4||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||50.4|38.0|<0.0001
71144036|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.132|||<|0.0001||95.0|1.353|2.91|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.910|1.353|<.0001
71144037|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.146|||<|0.0001||95.0|1.339|2.954|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.954|1.339|<.0001
71144038|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.173|||<|0.0001||95.0|1.311|3.036|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.036|1.311|<.0001
71144039|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.188|||<|0.0001||95.0|1.294|3.082|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.082|1.294|<.0001
71144040|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.215|||<|0.0001||95.0|1.26|3.169|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.169|1.260|<.0001
71144041|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.23|||<|0.0001||95.0|1.241|3.219|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.219|1.241|<.0001
71144042|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.256|||<|0.0001||95.0|1.203|3.309|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.309|1.203|<.0001
71144043|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.271|||<|0.0001||95.0|1.182|3.361|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.361|1.182|<.0001
71144044|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.298|||<|0.0001||95.0|1.142|3.454|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.454|1.142|<.0001
71144045|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.313||||0.0001||95.0|1.119|3.507|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.507|1.119|0.0001
71144046|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.34||||0.0003||95.0|1.076|3.603|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.603|1.076|0.0003
71144047|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.354||||0.0004||95.0|1.052|3.657|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.657|1.052|0.0004
70869554|NCT05544734|141224772|SUPERIORITY||Median Difference (Final Values)|-0.3||||0.69|TWO_SIDED|95.0|-1.85|1.25|||t-test, 2 sided||Direction = Hydrocodone group mean change (i.e., change = baseline to postoperative day 2) minus Non-Hydrocodone group mean change (i.e., change = baseline to postoperative day 2).|||1.25|-1.85|0.69
71144048|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.381||||0.0007||95.0|1.008|3.754|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.754|1.008|0.0007
70869555|NCT05544734|141224773|SUPERIORITY||Median Difference (Final Values)|2.3||||0.62|TWO_SIDED|95.0|-7.25|11.85|||t-test, 2 sided||Direction = Hydrocodone group mean change (i.e., change = postoperative day 3 to postoperative day 6) minus Non-Hydrocodone group mean change (i.e., change = postoperative day 3 to postoperative day 6).|||11.85|-7.25|0.62
71144049|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.396||||0.0009||95.0|0.983|3.809|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.809|0.983|0.0009
71144050|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.423||||0.0014||95.0|0.938|3.908|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.908|0.938|0.0014
71144051|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.438||||0.0017||95.0|0.912|3.963|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.963|0.912|0.0017
71144052|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.464||||0.0025||95.0|0.866|4.063|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.063|0.866|0.0025
71144053|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.479||||0.003||95.0|0.84|4.119|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.119|0.840|0.0030
71144054|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.506||||0.0042||95.0|0.792|4.219|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.219|0.792|0.0042
71144055|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.521||||0.0049||95.0|0.766|4.275|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.275|0.766|0.0049
71144056|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.547||||0.0064||95.0|0.718|4.377|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.377|0.718|0.0064
71144057|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.562||||0.0073||95.0|0.691|4.433|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.433|0.691|0.0073
71144058|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.589||||0.0091||95.0|0.643|4.535|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.535|0.643|0.0091
71144059|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.604||||0.0103||95.0|0.616|4.592|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.592|0.616|0.0103
71144060|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.631||||0.0125||95.0|0.567|4.695|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.695|0.567|0.0125
71144061|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.645||||0.0138||95.0|0.539|4.752|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.752|0.539|0.0138
70869556|NCT02513394|141224824|OTHER||Hazard Ratio (HR)|0.96||||0.65|TWO_SIDED|95.0|0.81|1.14|||Log Rank||This two sided p value was stratified by (neo)adjuvant chemotherapy (yes vs no) and age (\<=50 vs \>50).|||1.14|0.81|0.65
70869557|NCT02513394|141224825|OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.82|1.19||||||||1.19|0.82|
70869558|NCT02513394|141224826|OTHER||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.87|1.28||||||||1.28|0.87|
70869559|NCT02513394|141224827|OTHER||Hazard Ratio (HR)|1.32|||||TWO_SIDED|95.0|0.98|1.78||||||||1.78|0.98|
70869560|NCT02513394|141224828|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.57|1.23||||||||1.23|0.57|
70869561|NCT01218113|141224846|NON_INFERIORITY|Crierion for non-inferiority evaluation: The upper limit (UL) of the two-sided 97.5% confidence interval (CI) for the difference in change between the two arms (3D\_HIV Group - Control Group) is below 0.|Geometric Mean Ratio|0.801|||||TWO_SIDED|97.5|0.553|1.162|||Repeated-measures mixed model|||To show the difference in change from baseline of HIV-1 VL at week 48 between persons who received 3 doses of the HIV vaccine 732462 and persons who received placebo alone.||1.162|0.553|
70869562|NCT01218113|141224846|NON_INFERIORITY|Crierion for non-inferiority evaluation: The upper limit (UL) of the two-sided 97.5% confidence interval (CI) for the difference in change between the two arms (2D\_HIV Group - Control Group) is below 0.|Geometric Mean Ratio|1.184|||||TWO_SIDED|97.5|0.816|1.717|||Repeated-measures mixed model|||To show the difference in change from baseline of HIV-1 VL at week 48 between persons who received 2 doses of the HIV Vaccine 732462 and persons who received placebo alone.||1.717|0.816|
70869563|NCT01218113|141224847|NON_INFERIORITY|Criterion for non-inferiority evaluation: The upper limit (UL) of the two-sided 97.5% confidence interval (CI) for the difference in change between the two arms (3D\_HIV Group - Control Group) is below 0.|Mean Difference|-0.096|||||TWO_SIDED|97.5|-0.257|0.065|||Repeated-measures mixed model|||To show the difference in change from baseline of HIV-1 VL (log10-transformed values) at week 48 between persons who received 3 doses of the HIV Vaccine 732462 and persons who received placebo alone.||0.065|-0.257|
70869564|NCT01218113|141224847|NON_INFERIORITY|Criterion for non-inferiority evaluation: The upper limit (UL) of the two-sided 97.5% confidence interval (CI) for the difference in change between the two arms (2D\_HIV Group - Control Group) is below 0.|Mean Difference|0.073|||||TWO_SIDED|97.5|-0.088|0.235|||Repeated-measures mixed model|||To show the difference in change from baseline of HIV-1 VL (log10-transformed values) at week 48 between persons who received 2 doses of the HIV Vaccine 732462 and persons who received placebo alone.||0.235|-0.088|
70869565|NCT00967668|141224912|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Regression, Linear|Linear mixed-effects model with baseline, 3- and 12-month outcome values modeled as dependent variables||All participants were included in outcomes analyses using intention-to-treat principles. A linear mixed-effects model with baseline, 3- and 12-month outcome values modeled as dependent variables was used.This statistical approach allows the use of data from all participants as long as the dependent variable is available for at least one time point. Each subject was included as a random intercept to adjust for within-person correlations.||||<0.05
70869566|NCT02200211|141224923|NON_INFERIORITY|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior Pediatric Eye Disease Investigator Group (PEDIG) studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.31|||||ONE_SIDED|95.0||0.53|||||A 1-sided upper 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary outcome measure was change in amblyopic-eye VA from baseline to 16 weeks (14 to \<20 week window). The upper limit of a 1-sided 95% confidence interval (CI) was computed on the treatment group difference, using an analysis of covariance (ANCOVA) model, adjusted for baseline age and VA, including only participants completing the 16-week outcome in a modified intent-to-treat analysis. There was no imputation for missing data.||0.53||
70869567|NCT02200211|141224923|NON_INFERIORITY|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.3|||||ONE_SIDED|95.0||0.53|||||A 1-sided upper 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye VA from baseline to 16 weeks, adjusting for baseline covariates of age and visual acuity. For this sensitivity analysis, the primary analysis repeated but excluded data from participants (n=35) who completed the 16-week visit outside of the pre-defined protocol window (16 +/- 1 week).||0.53||
70869568|NCT02200211|141224923|NON_INFERIORITY|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.31|||||ONE_SIDED|95.0||0.54|||||A 1-sided 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye from baseline to 16 weeks, adjusting for baseline covariates of age and visual acuity. For this sensitivity analysis, multiple imputation was used to impute 16-week visual acuity scores for participants who missed the exam (n=15) or completed the 16-week exam outside of the pre-specified analysis window (n=7).||0.54||
70952177|NCT03596762|141405542|SUPERIORITY||Difference in LS means|-0.15|||=|0.2606|TWO_SIDED|95.0|-0.41|0.11|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||0.11|-0.41|= 0.2606
70952178|NCT03596762|141405542|SUPERIORITY||Difference in LS means|-0.27|||=|0.0479|TWO_SIDED|95.0|-0.53|0.0|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||0|-0.53|= 0.0479
70952179|NCT01038427|141405677|EQUIVALENCE|If the 90% confidence intervals were contained within the interval 80.0% to 125.0%, then the two products were considered to be therapeutically equivalent.|Ratio Test/Ref. Least Squares (LS) Means|106.644|||||TWO_SIDED|90.0|91.86|123.997||||||||123.997|91.860|
70952180|NCT01038427|141405678|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70952181|NCT01038427|141405678|SUPERIORITY|||||||0.0001|||||||ANCOVA|||||||0.0001
70952182|NCT01038427|141405679|EQUIVALENCE|90% confidence intervals within the interval 80.0% to 125.0%.|Ratio Test/Ref. LS Means|109.716|||||TWO_SIDED|90.0|93.316|129.159||||||||129.159|93.316|
70872254|NCT03782792|141229722|OTHER|||||||0.0044||||||One-sided P Value.|Wilcoxon (Mann-Whitney)|||The effect of spesolimab was evaluated by a Wilcoxon rank test using the RS. Any assessments after death, the use of escape medication (before or after Day 8), open label spesolimab on Day 8, or rescue medication with spesolimab after Day 8 were assigned worst ranks for the testing. Missing data at Week 4 were imputed and handled via assessment of ranks.|The difference between treatments, based on the RS, using a modified Hodges-Lehmann (HL) estimate of the median difference and 95% Confidence Intervals could not be calculated due to lack of valid data.|||0.0044
71144062|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.672||||0.0164||95.0|0.49|4.855|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.855|0.490|0.0164
71144063|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.687||||0.0179||95.0|0.462|4.912|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.912|0.462|0.0179
71144064|NCT00083889|141781656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.714||||0.0208||95.0|0.413|5.015|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||5.015|0.413|0.0208
71144065|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.049||||0.0004|TWO_SIDED|95.0|0.022|0.076|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EuroQoL Five Dimension (EQ-5D): Health state index baseline score (intercept and time since randomization are included as random effects).||0.076|0.022|0.0004
71144066|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048||||0.0003||95.0|0.022|0.075|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.075|0.022|0.0003
71144067|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048||||0.0003||95.0|0.022|0.074|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.074|0.022|0.0003
71144068|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047||||0.0003||95.0|0.021|0.072|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.072|0.021|0.0003
71144069|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046||||0.0004||95.0|0.021|0.072|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.072|0.021|0.0004
71144070|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045||||0.0005||95.0|0.02|0.071|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.071|0.020|0.0005
71144071|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045||||0.0007||95.0|0.019|0.07|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.070|0.019|0.0007
71144072|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044||||0.0011||95.0|0.017|0.07|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.070|0.017|0.0011
71144073|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.043||||0.0016||95.0|0.016|0.07|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.070|0.016|0.0016
71144074|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042||||0.0029||95.0|0.014|0.07|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.070|0.014|0.0029
70952183|NCT01038427|141405680|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70952184|NCT01038427|141405680|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70869569|NCT02200211|141224923|NON_INFERIORITY|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.33|||||ONE_SIDED|95.0||0.56|||||A 1-sided upper 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye VA from baseline to 16 weeks, adjusting for baseline covariates for age and visual acuity. For this post hoc sensitivity analysis, all participants with 16-week exams were included in the analysis regardless of whether or not the exam was completed within the pre-specified analysis window (14 to \<20 weeks after randomization).||0.56||
70869570|NCT02200211|141224923|NON_INFERIORITY|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.3|||||ONE_SIDED|95.0||0.53|||||A 1-sided upper 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye VA from baseline to 16-weeks, adjusting for baseline covariates of age and visual acuity. For this sensitivity analysis, we excluded 16-week outcomes from enrolled participants who were subsequently found to be ineligible for the study (n=7).||0.53||
70869571|NCT02200211|141224923|NON_INFERIORITY|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.33|||||ONE_SIDED|95.0||0.55|||||A 1-sided 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye visual acuity from baseline to 16 week, adjusting for baseline covariates of age and visual acuity. For this sensitivity analysis, we excluded 16-week outcomes from participants who received alternative treatment for at least 1 week during study follow-up (n=4).||0.55||
70869572|NCT02200211|141224923|SUPERIORITY||Mean Difference (Final Values)|0.31|||||TWO_SIDED|95.0|0.04|0.58|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive estimate values favor the patching treatment group.|Analysis of covariance included baseline age and visual acuity as adjustment covariates. The primary outcome measure was change in amblyopic-eye VA from baseline to 16 weeks (14 to \<20 week window). For this post hoc analysis, a 2-sided 95% confidence interval (CI) was computed on the treatment group difference, using an analysis of covariance (ANCOVA) model, adjusted for baseline age and VA, including only participants completing the 16-week outcome in a modified intent-to-treat analysis.||0.58|0.04|
70869573|NCT02200211|141224925|SUPERIORITY||Mean Difference (Final Values)|-2.7||||0.082|TWO_SIDED|95.0|-5.7|0.3||a priori threshold for statistical significance: 2-sided type I error rate of 5%|ANCOVA|Adjusted for baseline amblyopic-eye visual acuity.|A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|A modified intent-to-treat analysis was performed using an ANCOVA model to compare the effectiveness of two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. The primary outcome measure was change in amblyopic-eye VA from baseline to 16 weeks (14 to \<20 week window). A 2-sided 95% confidence interval (CI) was computed on the adjusted treatment group difference at 16 weeks. There was no imputation for missing data.||0.3|-5.7|0.082
70869574|NCT02200211|141224925|SUPERIORITY||Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-5.9|0.5|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|A modified intent-to-treat analysis was performed using an ANCOVA model to compare the change in amblyopic-eye visual acuity from baseline to 16 weeks for two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. For this sensitivity analyses, the primary analysis was repeated but excluded data from participants who completed the 16-week visit outside of the pre-specified 16 +/- 1 week protocol window (n=10 participants).||0.5|-5.9|
70869575|NCT02200211|141224925|SUPERIORITY||Mean Difference (Final Values)|-2.8|||||TWO_SIDED|95.0|-5.9|0.3|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|A modified intent-to-treat analysis was performed using an ANCOVA model to compare the change in amblyopic-eye visual acuity from baseline to 16 weeks (14 to \<20 week window) for two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. For this sensitivity analyses, the primary analysis was repeated but excluded data from participants later found to be ineligible for the study (n=2).||0.3|-5.9|
70952185|NCT01038427|141405681|SUPERIORITY|||||||0.2655|||||||Cochran-Mantel-Haenszel|||||||0.2655
70952186|NCT01038427|141405681|SUPERIORITY|||||||0.0009|||||||Cochran-Mantel-Haenszel|||||||0.0009
70952187|NCT01038427|141405681|SUPERIORITY|||||||0.1093|||||||Cochran-Mantel-Haenszel|||||||0.1093
71144075|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042||||0.0041||95.0|0.013|0.07|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.070|0.013|0.0041
71144076|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.041||||0.0076||95.0|0.011|0.071|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.071|0.011|0.0076
70952188|NCT01038427|141405682|SUPERIORITY|||||||0.9915|||||||Cochran-Mantel-Haenszel|||||||0.9915
70952189|NCT01038427|141405682|SUPERIORITY|||||||0.0312|||||||Cochran-Mantel-Haenszel|||||||0.0312
70952190|NCT01038427|141405682|SUPERIORITY|||||||0.0487|||||||Cochran-Mantel-Haenszel|||||||0.0487
70952191|NCT00588692|141405686|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||For 25-49% Ejection Fraction Subgroup||||<0.05
70952192|NCT00588692|141405686|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||35-49% Ejection Fraction Subgroup||||<0.05
70952193|NCT00588692|141405688|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANOVA|||||||0.06
70952194|NCT00588692|141405689|SUPERIORITY_OR_OTHER|||||||0.5|||||||ANOVA|||||||0.5
70952195|NCT00588692|141405689|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
70952196|NCT00588692|141405689|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
70952197|NCT00588692|141405690|SUPERIORITY_OR_OTHER|||||||0.26|||||||ANOVA|||||||0.26
70952198|NCT00588692|141405690|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
70952199|NCT00588692|141405690|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
70952200|NCT00588692|141405691|SUPERIORITY_OR_OTHER|||||||0.4|||||||ANOVA|||||||0.4
70952201|NCT00588692|141405692|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.9
70952202|NCT00588692|141405692|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
70952203|NCT00588692|141405692|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
70952204|NCT00588692|141405693|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.9
70952205|NCT00588692|141405694|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.9
70952206|NCT00588692|141405695|SUPERIORITY_OR_OTHER|||||||0.3|||||||ANOVA|||||||0.3
70952207|NCT00588692|141405696|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.9
70952208|NCT00588692|141405696|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
70952209|NCT00588692|141405696|SUPERIORITY_OR_OTHER|||||||0.24|||||||t-test, 2 sided|||||||0.24
70952210|NCT00588692|141405697|SUPERIORITY_OR_OTHER|||||||0.6|||||||ANOVA|||||||0.6
70952211|NCT00588692|141405698|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.9
70952212|NCT00588692|141405698|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
70952213|NCT00588692|141405698|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
70952214|NCT00588692|141405699|SUPERIORITY_OR_OTHER|||||||0.11|||||||ANOVA|||||||0.11
70952215|NCT00588692|141405699|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
70952216|NCT00588692|141405699|SUPERIORITY_OR_OTHER|||||||0.16|||||||t-test, 2 sided|||||||0.16
70952217|NCT00588692|141405700|SUPERIORITY_OR_OTHER|||||||0.4|||||||ANOVA|||||||0.4
70952218|NCT00588692|141405700|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
70952219|NCT00588692|141405700|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
70952220|NCT00588692|141405701|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.9
70952221|NCT00588692|141405701|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
70952222|NCT00588692|141405701|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
70952223|NCT03197766|141405764|SUPERIORITY||||||<|0.0001||||||Confirmatory statistical testing controlling for the Type I error rate was performed on the primary analysis for the primary endpoint.|ANCOVA|Two subjects in the BMN 111 group discontinued from the study before Week 52. The values for these 2 subjects were imputed for this analysis.||||||< 0.0001
70952224|NCT03197766|141405765|SUPERIORITY||||||<|0.0001||||||Confirmatory statistical testing controlling for the Type I error rate was performed on the primary analyses for the two key secondary endpoints.|ANCOVA|Missing assessments at Week 52 were imputed||||||< 0.0001
70952225|NCT03197766|141405766|SUPERIORITY||||||=|0.506||||||Confirmatory statistical testing controlling for the Type I error rate was performed on the primary analyses for the two key secondary endpoints.|ANCOVA|Missing assessments at Week 52 were imputed||||||= 0.506
70952226|NCT01647542|141405792|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.03|STANDARD_ERROR_OF_MEAN|0.126|<|0.001|TWO_SIDED|95.0|-1.27|-0.78||Stepwise Comparison: 1) TAK-875 50 mg versus (vs.) placebo, 2) TAK-875 25 mg vs. placebo. Step 2 was performed only if p-value at step 1 was \<=0.050.|Mixed Model Repeated Measures|Treatment, country, visit, and visit-by-treatment interaction as fixed factors, baseline value as covariate.||Assuming a standard deviation of 0.9% in change from baseline in HbA1c to Week 24 and a dropout rate of 15%, 210 participants per group provided at least 95% power to detect a treatment difference of 0.5% between treatment arms at a 2-sided significance level of 0.05.||-0.78|-1.27|<0.001
70952227|NCT01647542|141405792|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.126|<|0.001|TWO_SIDED|95.0|-1.07|-0.57||Stepwise Comparison: 1) TAK-875 50 mg versus (vs.) placebo, 2) TAK-875 25 mg vs. placebo. Step 2 was performed only if p-value at step 1 was \<=0.050.|Mixed Model Repeated Measures|Treatment, country, visit, and visit-by-treatment interaction as fixed factors, baseline value as covariate.||Assuming a standard deviation of 0.9% in change from baseline in HbA1c to Week 24 and a dropout rate of 15%, 210 participants per group provided at least 95% power to detect a treatment difference of 0.5% between treatment arms at a 2-sided significance level of 0.05.||-0.57|-1.07|<0.001
70952228|NCT01647542|141405793|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.66|||<|0.001|TWO_SIDED|95.0|2.99|10.72||No multiplicity adjustment.|Regression, Logistic|Treatment and baseline HbA1c as explanatory variables.||||10.72|2.99|<0.001
70952229|NCT01647542|141405793|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.42|||<|0.001|TWO_SIDED|95.0|1.81|6.49||No multiplicity adjustment.|Regression, Logistic|Treatment and baseline HbA1c as explanatory variables.||||6.49|1.81|<0.001
70952230|NCT01647542|141405794|SUPERIORITY_OR_OTHER||Least squares mean difference|-35.6|STANDARD_ERROR_OF_MEAN|4.36|<|0.001|TWO_SIDED|95.0|-44.2|-26.9||No multiplicity adjustment.|Mixed Model Repeated Measures|Treatment, country, visit, and visit-by-treatment interaction as fixed factors, baseline value covariate.||||-26.9|-44.2|<0.001
70952231|NCT01647542|141405794|SUPERIORITY_OR_OTHER||Least Squares mean Difference|-35.7|STANDARD_ERROR_OF_MEAN|4.36|<|0.001|TWO_SIDED|95.0|-44.3|-27.1||No multiplicity adjustment.|Mixed Model Repeated Measures|Treatment, country, visit, and visit-by-treatment interaction as fixed factors, baseline value as covariate.||||-27.1|-44.3|<0.001
70952232|NCT01647542|141405795|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|29.72||0.846|TWO_SIDED|95.0|-57.9|69.6||No multiplicity adjustments.|ANCOVA|Treatment and country as fixed factors and baseline value as covariate.||||69.6|-57.9|0.846
70952233|NCT01647542|141405795|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-24.9|STANDARD_ERROR_OF_MEAN|30.4||0.427|TWO_SIDED|95.0|-90.1|40.3||No multiplicity adjustments.|ANCOVA|Treatment and country as fixed factors and baseline value as covariate.||||40.3|-90.1|0.427
70952234|NCT03086655|141405796|SUPERIORITY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.9|1.93|||||This is the 'inflation part' of the zero inflated negative binomial model. We used cluster robust standard errors due to the multiple observations over time being nested within participant. Result shows odds of intervention group relative to control.|"We used zero inflated negative binomial regression due to the count variable being overdispersed and containing a large number of 0. The analysis aggregated over multiple time points per participant. It simultaneously tests the odds of having 0 openings and the difference in the rate of openings between the 2 intervention groups. These 2 results are reported separately.~Null hypothesis 1: the odds of having 0 openings is lower in intervention than control group."||1.93|0.90|
70952235|NCT03086655|141405796|SUPERIORITY||incidence rate ratio (IRR)|0.77|||||TWO_SIDED|95.0|0.61|0.98|||||This is the negative binomial part of the model. We used cluster robust standard errors due to the multiple observations being nested within participant. Result shows intervention group had lower rate of openings relative to control.|"We used zero inflated negative binomial regression due to the count variable being overdispersed and containing many 0s. The analysis aggregated over multiple time points per participant. It simultaneously tests the odds of having 0 openings and the difference in the rate of openings between the 2 intervention groups. These 2 results are reported separately.~Null hypothesis 2: the incidence rate ratio for # days with box opening is \>1, i.e. more openings in intervention than control group."||0.98|0.61|
70952236|NCT03086655|141405797|SUPERIORITY|||||||0.08|||||||Chi-squared|overall Wald chi2 (2 d.f.), simultaneously testing if parameters for both 6 mo. by intervention and 12 mo. by intervention are different from 0.||"statistical analyses is a GEE model with logit link function and binomial distribution with odds of undetectable VL as outcome and as predictors: intervention, time and time\*intervention. We hypothesize that over time, the odds of undetectable VL will be higher for the intervention than the control group, which would be reflected in a significant interaction effect time\*intervention.~H0: no significant interaction effect time\*intervention"||||0.08
70952237|NCT03086655|141405798|SUPERIORITY||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.13|<|0.05|TWO_SIDED|95.0|-0.11|0.43||a priori threshold for statistical significance was p=0.05.|t-test, 2 sided|(equal variances assumed)|Difference = control group - treatment group|||0.43|-0.11|<0.05
70869576|NCT02200211|141224925|SUPERIORITY||Mean Difference (Final Values)|-1.9|||||TWO_SIDED|95.0|-5.0|1.2|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye from baseline to 16 weeks, adjusting for baseline visual acuity. For this sensitivity analysis, multiple imputation was used to impute 16-week visual acuity scores for participants who missed the exam (n=3) or completed the 16-week exam outside of the pre-specified analysis window (n=2).||1.2|-5.0|
70869577|NCT02200211|141224925|SUPERIORITY||Mean Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-5.5|0.5|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|An ANCOVA model was fit to compare the change in amblyopic-eye visual acuity from baseline to 16 weeks (14 to \<20 week window) for two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. For this post hoc sensitivity analyses, the primary analysis was repeated but included data from participants who completed the 16-week visit outside the analysis window (n=2, range:14 to 28 weeks post randomization).||0.5|-5.5|
70869578|NCT02200211|141224925|SUPERIORITY||Mean Difference (Final Values)|-2.6|||||TWO_SIDED|95.0|-5.7|0.4|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|An ANCOVA model was fit to compare the change in amblyopic-eye visual acuity from baseline to 16 weeks (14 to \<20 week window) for two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. For this sensitivity analyses, the primary analysis was repeated but included prior amblyopia treatment as an adjustment covariate (in addition to baseline visual acuity) in the model.||0.4|-5.7|
70869579|NCT02200211|141224929|SUPERIORITY||Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|-4.0|13.0|||||Binomial regression was used to compare the group proportions (patching - binocular treatment) of participants classified as improving 2 or more logMAR lines from baseline at the 16-week visit.|Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 16-week visit, adjusting for baseline age group (5 to \<7, 7 to \<13 years) and baseline visual acuity (treated as a continuous covariate).||13|-4|
70869580|NCT02200211|141224929|SUPERIORITY||Risk Difference (RD)|-15.0|||||TWO_SIDED|95.0|-31.0|2.0|||||Binomial regression was used to compare the group proportions (binocular treatment - patching) of participants classified as improving 2 or more logMAR lines (≥ 10 letters) from baseline at the 16-week visit.|Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 16-week visit, adjusting for baseline visual acuity.||2|-31|
70952238|NCT03086655|141405799|SUPERIORITY|||||||0.08|||||||Chi-squared|overall Wald chi2 (4 d.f.), simultaneously testing if parameters for all follow-ups by intervention are different from 0.||"statistical analyses is a GEE model with logit link function and binomial distribution with odds of optimal adherence as outcome and as predictors: intervention, time and time\*intervention. We hypothesize that over time, the odds of optimal adherence will be higher for the intervention than the control group, which would be reflected in a significant interaction effect time\*intervention.~H0: no significant interaction effect time\*intervention"||||0.08
70952239|NCT03008005|141405801|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||< 0.05
70869581|NCT02200211|141224930|SUPERIORITY||Risk Difference (RD)|2.0|||||TWO_SIDED|95.0|-1.0|5.0|||||Binomial regression was used to compare the group proportions (patching - binocular treatment) of participants classified as having amblyopia resolution at the 16-week visit.|Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 16-week visit, adjusting for baseline age group (5 to \<7, 7 to \<13 years) and baseline visual acuity (20/40, 20/50 or worse).||5|-1|
70869582|NCT02200211|141224931|SUPERIORITY|||||||0.83||||||For testing the interaction term, the a priori threshold for statistical significance was 0.05.|ANCOVA|Previously described above in the Statistical Analysis Overview section.||A linear mixed model was used to compare the rate of amblyopic-eye visual acuity improvement between the treatment groups. The ANCOVA model included an interaction term with treatment group and time to compare the change in visual acuity over follow-up by treatment group, adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity. If the interaction term was not statistically significant (p\>0.05), no further comparisons would be performed.||||0.83
70869583|NCT02200211|141224932|SUPERIORITY|||||||0.83||||||The a priori threshold for statistical significance of the interaction term (gender and treatment group) was 0.05.|ANCOVA|Previously described in the Statistical Analysis Overview.||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and gender, adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.||||0.83
70869584|NCT02200211|141224932|SUPERIORITY|||||||0.54||||||The a priori threshold for statistical significance of the interaction term (race/ethnicity status and treatment group) was 0.05.|ANCOVA|Four participants (1 binocular treatment group, 3 patching group) were excluded from the analysis due to unknown/not reported race/ethnicity status.||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and race/ethnicity status (White/non-Hispanic, Non-White or Hispanic), adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.||||0.54
70869585|NCT02200211|141224932|SUPERIORITY|||||||0.8||||||The a priori threshold for statistical significance of the interaction term (age and treatment group) was 0.05.|ANCOVA|||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and age at baseline (treated as a continuous factor in the model), adjusting for the main effects of the interaction term and baseline visual acuity.||||0.80
70869586|NCT02200211|141224932|SUPERIORITY|||||||0.99||||||The a priori threshold for statistical significance of the interaction term (baseline amblyopic-eye visual acuity and treatment group) was 0.05.|ANCOVA|||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and baseline amblyopic-eye visual acuity (treated as a continuous factor in the model), adjusting for the main effects of the interaction term and baseline age.||||0.99
70869587|NCT02200211|141224932|SUPERIORITY|||||||0.87||||||The a priori threshold for statistical significance of the interaction term (prior amblyopia treatment and treatment group) was 0.05|ANCOVA|||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and prior amblyopia treatment (Yes/No), adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.||||0.87
70869588|NCT02200211|141224932|SUPERIORITY|||||||0.33||||||The a priori threshold for statistical significance of the interaction term (baseline stereoacuity and treatment group) was 0.05.|ANCOVA|||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and baseline stereoacuity (nil, better than nil), adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.||||0.33
70869589|NCT02200211|141224932|SUPERIORITY|||||||0.23||||||The a priori threshold for statistical significance of the interaction term (presence of a near heterotropia at baseline and treatment group) was 0.05.|ANCOVA|||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and presence of a near heterotropia (measured by SPCT) at baseline (Yes/No), adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.||||0.23
70869590|NCT02200211|141224937|SUPERIORITY|||||||0.66||||||The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||The Wilcoxon rank-sum test was used to compare the distribution of change in stereoacuity levels from baseline to 16 weeks by treatment group.||||0.66
70952240|NCT03008005|141405802|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||< 0.05
70952241|NCT01040169|141405830|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71144077|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.0105||95.0|0.009|0.071|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.071|0.009|0.0105
70869591|NCT02200211|141224937|SUPERIORITY|||||||0.83||||||A priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|||The Wilcoxon rank-sum test was used to compare the distribution of change in stereoacuity levels from baseline to 16 weeks by treatment group.||||0.83
70869592|NCT02200211|141224938|SUPERIORITY|||||||0.19||||||The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||The Wilcoxon rank-sum test was used to compare the distribution of change in stereoacuity levels from baseline to 16 weeks by treatment group.||||0.19
70952242|NCT01040169|141405831|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70952243|NCT00558792|141405832|SUPERIORITY_OR_OTHER|||||||0.0099||95.0|||||Chi-squared|||||||0.0099
70952244|NCT00558792|141405833|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
70952245|NCT00558792|141405834|SUPERIORITY_OR_OTHER|||||||0.1212||95.0|||||Chi-squared|||||||0.1212
70952246|NCT00558792|141405836|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|||||||0.0200
70952247|NCT00558792|141405837|SUPERIORITY_OR_OTHER|||||||0.0044||95.0|||||ANOVA|||||||0.0044
70952248|NCT00558792|141405838|SUPERIORITY_OR_OTHER|||||||0.0371||95.0|||||ANOVA|||||||0.0371
70952249|NCT00558792|141405839|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|14.1||||0.2758|TWO_SIDED|95.0|-11.4|39.6||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||39.6|-11.4|0.2758
70952250|NCT00558792|141405839|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|12.3||||0.3102|TWO_SIDED|95.0|-11.1|35.6||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||35.6|-11.1|0.3102
70952251|NCT00558792|141405839|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|1.9||||0.8893|TWO_SIDED|95.0|-24.6|28.4||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||28.4|-24.6|0.8893
70952252|NCT00558792|141405840|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-1.7||||0.2511|TWO_SIDED|95.0|-4.7|1.3||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||1.3|-4.7|0.2511
70952253|NCT00558792|141405840|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|1.3||||0.4985|TWO_SIDED|95.0|-2.6|5.3||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||5.3|-2.6|0.4985
71144078|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039||||0.0179||95.0|0.007|0.072|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.072|0.007|0.0179
70952254|NCT00558792|141405840|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-3.1||||0.0693|TWO_SIDED|95.0|-6.5|0.4||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||0.4|-6.5|0.0693
71144079|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039||||0.0236||95.0|0.005|0.072|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.072|0.005|0.0236
71144080|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038||||0.037||95.0|0.002|0.073|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.073|0.002|0.0370
71144081|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037||||0.0464||95.0|0.001|0.074|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.074|0.001|0.0464
70952255|NCT00558792|141405841|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|-1.5||||0.9104|TWO_SIDED|95.0|-27.9|24.8||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||24.8|-27.9|0.9104
70952256|NCT00558792|141405841|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|-12.6||||0.2857|TWO_SIDED|95.0|-35.7|10.5||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||10.5|-35.7|0.2857
70952257|NCT00558792|141405841|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|11.1||||0.3664|TWO_SIDED|95.0|-13.3|35.5||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||35.5|-13.3|0.3664
70952258|NCT00558792|141405842|SUPERIORITY_OR_OTHER||Difference in Specifcity between Doses|-3.7||||0.1322|TWO_SIDED|95.0|-8.7|1.2||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||1.2|-8.7|0.1322
70952259|NCT00558792|141405842|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-1.3||||0.6381|TWO_SIDED|95.0|-6.9|4.2||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||4.2|-6.9|0.6381
70952260|NCT00558792|141405842|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-2.4||||0.3217|TWO_SIDED|95.0|-7.2|2.4||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||2.4|-7.2|0.3217
70952261|NCT00558792|141405843|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|7.6||||0.5843|TWO_SIDED|95.0|-19.6|34.7||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||34.7|-19.6|0.5843
70952262|NCT00558792|141405843|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|4.6||||0.7197|TWO_SIDED|95.0|-20.5|29.7||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||29.7|-20.5|0.7197
70952263|NCT00558792|141405843|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|3.0||||0.8292|TWO_SIDED|95.0|-24.1|30.1||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||30.1|-24.1|0.8292
70952264|NCT00558792|141405844|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-4.2||||0.0888|TWO_SIDED|95.0|-9.0|0.7||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||0.7|-9.0|0.0888
71144082|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036||||0.0667||95.0|-0.002|0.075|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.075|-0.002|0.0667
71144083|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036||||0.08||95.0|-0.004|0.076|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.076|-0.004|0.0800
71144084|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035||||0.107||95.0|-0.007|0.077|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.077|-0.007|0.1070
71144085|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.034||||0.1237||95.0|-0.009|0.078|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.078|-0.009|0.1237
71144086|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033||||0.1561||95.0|-0.013|0.079|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.079|-0.013|0.1561
71144087|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033||||0.1752||95.0|-0.015|0.08|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.080|-0.015|0.1752
71144088|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.2112||95.0|-0.018|0.081|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.081|-0.018|0.2112
71144089|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031||||0.2319||95.0|-0.02|0.082|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.082|-0.020|0.2319
71144090|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.2698||95.0|-0.023|0.084|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.084|-0.023|0.2698
71144091|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.291||95.0|-0.025|0.085|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.085|-0.025|0.2910
71144092|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.029||||0.3293||95.0|-0.029|0.086|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.086|-0.029|0.3293
71144093|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028||||0.3504||95.0|-0.031|0.087|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.087|-0.031|0.3504
71144094|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.027||||0.3881||95.0|-0.034|0.089|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.089|-0.034|0.3881
71144095|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.027||||0.4086||95.0|-0.036|0.09|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.090|-0.036|0.4086
70869593|NCT02200211|141224938|SUPERIORITY|||||||0.69||||||A priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||The Wilcoxon rank-sum test was used to compare the distribution of change in stereoacuity levels from baseline to 16 weeks by treatment group.||||0.69
70869594|NCT02200211|141224944|SUPERIORITY||Mean Difference (Final Values)|0.16|||||TWO_SIDED|95.0|0.02|0.3|||||A 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) in mean change in fellow-eye visual acuity from baseline to 16 weeks. Positive values favor the binocular treatment group.|The treatment group difference in the change in fellow-eye visual acuity from baseline to 16 weeks (logMAR lines) was evaluated in an analysis of covariance model, adjusted for baseline fellow-eye visual acuity.||0.30|0.02|
71144096|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026||||0.4449||95.0|-0.04|0.091|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.091|-0.040|0.4449
71144097|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.025||||0.4646||95.0|-0.042|0.092|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.092|-0.042|0.4646
71144098|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024||||0.499||95.0|-0.046|0.094|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.094|-0.046|0.4990
71144099|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024||||0.5176||95.0|-0.048|0.095|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.095|-0.048|0.5176
71144100|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023||||0.5501||95.0|-0.051|0.097|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.097|-0.051|0.5501
71144101|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022||||0.5675||95.0|-0.054|0.098|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.098|-0.054|0.5675
71144102|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.021||||0.5979||95.0|-0.057|0.099|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.099|-0.057|0.5979
71144103|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.021||||0.6141||95.0|-0.059|0.1|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.100|-0.059|0.6141
71144104|NCT00083889|141781657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.6424||95.0|-0.063|0.102|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.102|-0.063|0.6424
71144105|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.026|||<|0.0001|TWO_SIDED|95.0|2.088|5.965|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Euro-QoL Visual Analog Scale (EQ-VAS) baseline score (intercept and time since randomization are included as random effects).||5.965|2.088|<.0001
71144106|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.165|||<|0.0001||95.0|2.269|6.061|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.061|2.269|<.0001
71144107|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.243|||<|0.0001||95.0|2.358|6.128|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.128|2.358|<.0001
71144108|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.382|||<|0.0001||95.0|2.494|6.269|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.269|2.494|<.0001
71144109|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.459|||<|0.0001||95.0|2.558|6.361|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.361|2.558|<.0001
70952265|NCT00558792|141405844|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-0.8||||0.7796|TWO_SIDED|95.0|-6.4|4.8||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||4.8|-6.4|0.7796
70952266|NCT00558792|141405844|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-3.4||||0.1662|TWO_SIDED|95.0|-8.2|1.5||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||1.5|-8.2|0.1662
70952267|NCT02284009|141405885|SUPERIORITY||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|0.0|0.24|||||Analysis was performed using a Bayesian model incorporating historical placebo data using a robust mixture prior. Values above are 95% credible intervals. Probability of treatment difference (Albiglutide - Placebo) \>= 0.2 nmol/L = 0.097.|||0.24|0.00|
70952268|NCT04092530|141405969|OTHER||Risk Ratio (RR)|0.82||||0.12|TWO_SIDED|95.0|0.64|1.05|||Mixed Models Analysis|Adjusted for time; clustering by clinical site accounted for with random intercept||Please note that there were only 7 units (community health clinics) analyzed at Level 2 of this multilevel study, but due to the crossover design of the study, they were each observed under both the Control and Intervention conditions. Therefore, the Units Analyzed entered above reflect the 7 clinics under both conditions and should not be summed to 14.||1.05|0.64|0.12
70952269|NCT04092530|141405970|OTHER||Risk Ratio (RR)|0.89||||0.33|TWO_SIDED|95.0|0.7|1.13|||Mixed Models Analysis|Adjusted for time; random intercept for clinical site||||1.13|0.70|0.33
70952270|NCT04092530|141405971|OTHER||Risk Ratio (RR)|1.1||||0.88|TWO_SIDED|95.0|0.33|3.73|||Mixed Models Analysis|Adjusted for time; random intercept for clinical site||||3.73|0.33|0.88
70952271|NCT03301155|141405975|SUPERIORITY|||||||0.001|||||||Regression, Logistic|Comparison performed on the regression parameters scale. Estimates for mean time obtained under assumption of exponentially distributed time-to-event.||||||0.001
70952272|NCT03301155|141405975|SUPERIORITY|superiority margin for hazard ratio was prespecified as 0.846. Lower hazard is better thus the upper confidence limit of HR expected to be lesser than margin|Hazard Ratio (HR)|0.645||||0.0218|TWO_SIDED|95.0|0.496|0.839|||Regression, Cox||Lower HR is better|||0.839|0.496|0.0218
70952273|NCT03301155|141405976|SUPERIORITY|||||||0.0003||||||Adjusted with Holm method for multiple comparrisons|Fisher Exact|||Comparison between groups on week 4||||0.0003
70952274|NCT03301155|141405976|SUPERIORITY|Adjusted with Holm method for multiple comparrisons||||||0.0003|||||||Fisher Exact|||Comparison between groups on week 8||||0.0003
70952275|NCT03301155|141405976|SUPERIORITY|||||||0.0021|||||||Fisher Exact|||Comparison between groups on week 12||||0.0021
70952276|NCT03301155|141405977|SUPERIORITY|||||||0.1372|||||||Fisher Exact|||||||0.1372
70952277|NCT03301155|141405978|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
70952278|NCT03301155|141405979|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
70952279|NCT00384189|141405985|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|9.8|STANDARD_ERROR_OF_MEAN|4.3||0.0116|TWO_SIDED|95.0|1.4|18.3|||ANCOVA|Baseline value and age as covariates. One-sided p-value, significance level 2.5%.||||18.3|1.4|0.0116
70952280|NCT00384189|141405985|SUPERIORITY_OR_OTHER||Least Square Means Difference|9.4|STANDARD_ERROR_OF_MEAN|4.3||0.0148|TWO_SIDED|95.0|0.9|17.8|||ANCOVA|Baseline value and age as covariates. One-sided p-value, significance level 2.5%.||||17.8|0.9|0.0148
70952281|NCT00384189|141405985|SUPERIORITY_OR_OTHER||Least Squares Means Difference|12.0|STANDARD_ERROR_OF_MEAN|4.3||0.0028|TWO_SIDED|95.0|3.5|20.4|||ANCOVA|Baseline value and age as covariates. One-sided p-value, significance level 2.5%.||||20.4|3.5|0.0028
70952282|NCT00384189|141405986|SUPERIORITY_OR_OTHER|||||||0.1362||||||Two-sided p-value, significance level 5%.|Log Rank|||||||0.1362
70952283|NCT00384189|141405986|SUPERIORITY_OR_OTHER|||||||0.0891||||||Two-sided p-value, significance level 5%.|Log Rank|||||||0.0891
70952284|NCT00384189|141405986|SUPERIORITY_OR_OTHER|||||||0.1574||||||Two-sided p-value, significance level 5%.|Log Rank|||||||0.1574
70952285|NCT00384189|141405987|SUPERIORITY_OR_OTHER|||||||0.001||||||One-sided p-value for superiority, significance level 2.5%.|Wilcoxon (Mann-Whitney)|||||||0.0010
70952286|NCT00384189|141405987|SUPERIORITY_OR_OTHER|||||||0.0006||||||One-sided p-value for superiority, significance level 2.5%.|Wilcoxon (Mann-Whitney)|||||||0.0006
70952287|NCT00384189|141405987|SUPERIORITY_OR_OTHER|||||||0.0002||||||One-sided p-value for superiority, significance level 2.5%.|Wilcoxon (Mann-Whitney)|||||||0.0002
70952288|NCT04546425|141406017|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference :|-13.5|||||TWO_SIDED|95.0|-18.3|-8.7|||||2-Sided 95% CIs were calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.|Serotype 1||-8.7|-18.3|
70952289|NCT04546425|141406017|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-17.9|||||TWO_SIDED|95.0|-23.2|-12.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 3||-12.4|-23.2|
70952290|NCT04546425|141406017|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-11.0|||||TWO_SIDED|95.0|-16.0|-5.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 4||-5.9|-16.0|
70952291|NCT04546425|141406017|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-12.6|||||TWO_SIDED|95.0|-17.8|-7.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 5||-7.2|-17.8|
70952292|NCT04546425|141406017|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-14.1|||||TWO_SIDED|95.0|-19.5|-8.6|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 6A||-8.6|-19.5|
70952293|NCT04546425|141406017|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-15.8|||||TWO_SIDED|95.0|-21.0|-10.6|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 6B||-10.6|-21.0|
70952294|NCT04546425|141406017|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-2.6|||||TWO_SIDED|95.0|-6.3|1.1|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 7F||1.1|-6.3|
70952295|NCT04546425|141406017|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-14.3|||||TWO_SIDED|95.0|-19.7|-8.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 9V||-8.9|-19.7|
70952296|NCT04546425|141406017|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-3.3|||||TWO_SIDED|95.0|-7.9|1.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 14||1.4|-7.9|
70952297|NCT04546425|141406017|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-5.5|||||TWO_SIDED|95.0|-10.6|-0.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 18C||-0.4|-10.6|
70952298|NCT04546425|141406017|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-1.7|||||TWO_SIDED|95.0|-4.8|1.3|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 19A||1.3|-4.8|
70952299|NCT04546425|141406017|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-1.4|||||TWO_SIDED|95.0|-4.0|1.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 19F||1.2|-4.0|
70952300|NCT04546425|141406017|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-18.3|||||TWO_SIDED|95.0|-23.6|-12.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 23F||-12.9|-23.6|
70952301|NCT04546425|141406017|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|59.9|||||TWO_SIDED|95.0|55.6|64.1|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 8||64.1|55.6|
70869595|NCT02200211|141224945|SUPERIORITY||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-1.1|1.3|||||A 95% confidence interval was computed on the treatment group difference (binocular treatment - patching) of the adjusted mean change in fellow-eye visual acuity from baseline to 16 weeks.|An analysis of covariance (ANCOVA) model was used to compute the treatment group difference in the mean change in fellow-eye visual acuity (letters) from baseline to 16 weeks, adjusting for baseline visual acuity. A 2-sided 95% confidence interval was computed on the adjusted treatment group difference.||1.3|-1.1|
70952302|NCT04546425|141406017|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|-7.6|||||TWO_SIDED|95.0|-13.1|-2.1|||||2-Sided 95% CI based on the Percent difference for the difference in proportions expressed as a percentage.|Serotype 10A||-2.1|-13.1|
70952303|NCT04546425|141406017|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|57.6|||||TWO_SIDED|95.0|53.1|61.9|||||2-Sided 95% CI based on the Percent difference for the difference in proportions expressed as a percentage.|Serotype 11A||61.9|53.1|
71144110|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.598|||<|0.0001||95.0|2.65|6.547|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.547|2.650|<.0001
71144111|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.676|||<|0.0001||95.0|2.689|6.662|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.662|2.689|<.0001
70952304|NCT04546425|141406017|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|-6.2|||||TWO_SIDED|95.0|-11.7|-0.7|||||2-Sided 95% CI based on the Percent difference for the difference in proportions expressed as a percentage.|Serotype 12F||-0.7|-11.7|
70952305|NCT04546425|141406017|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|57.8|||||TWO_SIDED|95.0|53.3|62.1|||||2-Sided 95% CI based on the Percent difference for the difference in proportions expressed as a percentage.|Serotype 15B||62.1|53.3|
70952306|NCT04546425|141406017|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|57.8|||||TWO_SIDED|95.0|53.3|62.1|||||2-Sided 95% CI based on the Percent difference for the difference in proportions expressed as a percentage.|Serotype 22F||62.1|53.3|
71144112|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.815|||<|0.0001||95.0|2.741|6.889|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.889|2.741|<.0001
71144113|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.892|||<|0.0001||95.0|2.76|7.024|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||7.024|2.760|<.0001
70869596|NCT02200211|141224946|SUPERIORITY|||||||0.32|||||||Fisher Exact|||Fisher's exact test was used to perform the treatment group comparison of the proportion of participants who developed a new ocular deviation and/or worsening of a pre-existing ocular deviation by 10 prism diopters at the 16-week visit.||||0.32
71144114|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.031|||<|0.0001||95.0|2.78|7.283|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||7.283|2.780|<.0001
70869597|NCT02200211|141224946|SUPERIORITY|||||||0.68|||||||Fisher Exact|||Fisher's exact test was used to perform the treatment group comparison of the proportion of participants who developed a new ocular deviation and/or worsening of a pre-existing ocular deviation by 10 prism diopters at the 16-week visit.||||0.68
70869598|NCT02200211|141224947|SUPERIORITY|||||||0.17|||||||Fisher Exact|||The Fisher exact test was used to compare the percentage of parents who reported that their child had experienced diplopia (yes/no) at the 16-week visit by treatment group.||||0.17
71144115|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.109|||<|0.0001||95.0|2.783|7.435|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||7.435|2.783|<.0001
71144116|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.248|||<|0.0001||95.0|2.776|7.72|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||7.720|2.776|<.0001
70869599|NCT02200211|141224947|SUPERIORITY|||||||0.48|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||0.48
70869600|NCT02200211|141224947|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||The Fisher exact test was used to compare the percentage of parents who reported that their child had experienced diplopia (yes/no) at the 16-week visit by treatment group.||||>0.99
70869601|NCT02200211|141224947|SUPERIORITY||||||>|0.99|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||>0.99
70869602|NCT02200211|141224948|SUPERIORITY|||||||0.05|||||||Fisher Exact|||The Fisher exact test was used to compare the percentage of participants who reported diplopia (yes/no) at the 16-week visit by treatment group.||||0.05
71144117|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.325|||<|0.0001||95.0|2.767|7.884|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||7.884|2.767|<.0001
71144118|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.464|||<|0.0001||95.0|2.741|8.188|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||8.188|2.741|<.0001
71144119|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.542||||0.0001||95.0|2.723|8.361|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||8.361|2.723|0.0001
71144120|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.681||||0.0002||95.0|2.683|8.679|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||8.679|2.683|0.0002
71144121|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.758||||0.0003||95.0|2.657|8.859|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||8.859|2.657|0.0003
71144122|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.898||||0.0004||95.0|2.607|9.188|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||9.188|2.607|0.0004
71144123|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.975||||0.0006||95.0|2.576|9.374|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||9.374|2.576|0.0006
71144124|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.114||||0.0009||95.0|2.517|9.711|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||9.711|2.517|0.0009
71144125|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.191||||0.0011||95.0|2.482|9.9|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||9.900|2.482|0.0011
71144126|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.331||||0.0015||95.0|2.417|10.244|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||10.244|2.417|0.0015
71144127|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.408||||0.0018||95.0|2.379|10.436|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||10.436|2.379|0.0018
71144128|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.547||||0.0025||95.0|2.309|10.785|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||10.785|2.309|0.0025
71144129|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.624||||0.0029||95.0|2.269|10.98|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||10.980|2.269|0.0029
71144130|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.764||||0.0037||95.0|2.195|11.332|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||11.332|2.195|0.0037
71144131|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.841||||0.0042||95.0|2.153|11.529|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||11.529|2.153|0.0042
70869603|NCT02200211|141224948|SUPERIORITY|||||||0.02|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||0.02
70869604|NCT02200211|141224948|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||The Fisher exact test was used to compare the percentage of participants who reported diplopia (yes/no) at the 16-week visit by treatment group.||||>0.99
70869605|NCT02200211|141224948|SUPERIORITY||||||>|0.99|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||>0.99
70869606|NCT01918774|141224951|OTHER|Pre-post analysis comparing weeks worked in the 6 months preceding baseline and the 6 month study follow-up.|||||<|0.001||||||A priori threshold of significance was p\<.05|within groups t-test|||||||<.001
70869607|NCT00042289|141224964|SUPERIORITY||Geometric mean ratio|0.62||||0.055|TWO_SIDED|90.0|0.44|0.88||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.88|0.44|0.055
70869608|NCT00042289|141224964|SUPERIORITY||Geometric mean ratio|0.64|||<|0.001|TWO_SIDED|90.0|0.55|0.73||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.73|0.55|<0.001
70869609|NCT00042289|141224964|SUPERIORITY||Geometric mean ratio|0.68||||0.22|TWO_SIDED|90.0|0.44|1.04||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.04|0.44|0.22
70869610|NCT00042289|141224964|SUPERIORITY||Geometric mean ratio|0.6|||<|0.001|TWO_SIDED|90.0|0.49|0.72||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.72|0.49|<0.001
70869611|NCT00042289|141224964|SUPERIORITY||Geometric mean ratio|0.76|||<|0.05|TWO_SIDED|90.0|0.64|0.89||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.89|0.64|<0.05
70869612|NCT00042289|141224964|SUPERIORITY||Geometric mean ratio|0.71|||<|0.05|TWO_SIDED|90.0|0.57|0.88||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.88|0.57|<0.05
70869613|NCT00042289|141224964|SUPERIORITY||Geometric mean ratio|0.98||||0.78|TWO_SIDED|90.0|0.71|1.35||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.35|0.71|0.78
71144132|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.98||||0.0053||95.0|2.076|11.884|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||11.884|2.076|0.0053
71144133|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.057||||0.0059||95.0|2.032|12.083|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||12.083|2.032|0.0059
71144134|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.197||||0.0072||95.0|1.953|12.441|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||12.441|1.953|0.0072
71144135|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.274||||0.0079||95.0|1.908|12.64|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||12.640|1.908|0.0079
71144136|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.413||||0.0093||95.0|1.826|13.0|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||13.000|1.826|0.0093
71144137|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.491||||0.0101||95.0|1.78|13.201|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||13.201|1.780|0.0101
71144138|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.63||||0.0117||95.0|1.697|13.562|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||13.562|1.697|0.0117
71144139|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.707||||0.0126||95.0|1.65|13.764|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||13.764|1.650|0.0126
71144140|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.846||||0.0144||95.0|1.565|14.127|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||14.127|1.565|0.0144
71144141|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.924||||0.0153||95.0|1.518|14.329|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||14.329|1.518|0.0153
71144142|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.063||||0.0172||95.0|1.432|14.693|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||14.693|1.432|0.0172
70869614|NCT00042289|141224965|SUPERIORITY||Geometric mean ratio|0.51|||<|0.05|TWO_SIDED|90.0|0.42|0.63||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.63|0.42|<0.05
71144143|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.14||||0.0182||95.0|1.384|14.896|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||14.896|1.384|0.0182
71144144|NCT00083889|141781658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.279||||0.0201||95.0|1.297|15.261|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||15.261|1.297|0.0201
71144145|NCT01283555|141781708|SUPERIORITY_OR_OTHER|||||||0.487||95.0||||The p-value presented here represents a comparison of the total number of non-iatrogenic findings at baseline and after one week of product use.|Fisher Exact|||Fishers exact test was used to compare the frequency of non-iatrogenic colposcopic findings at baseline and follow-up visits (after one week of twice-daily product use).||||0.4870
70869615|NCT00042289|141224965|SUPERIORITY||Geometric mean ratio|0.73|||<|0.05|TWO_SIDED|90.0|0.63|0.84||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.84|0.63|<0.05
70869616|NCT00042289|141224965|SUPERIORITY||Geometric mean ratio|0.58||||0.03|TWO_SIDED|90.0|0.34|0.98||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.98|0.34|0.03
70869617|NCT00042289|141224965|SUPERIORITY||Geometric mean ratio|0.67||||0.001|TWO_SIDED|90.0|0.51|0.89||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.89|0.51|0.001
70869618|NCT00042289|141224965|SUPERIORITY||Geometric mean ratio|1.34||||0.0684|TWO_SIDED|||||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||||0.0684
70869619|NCT00042289|141224965|SUPERIORITY||Geometric mean ratio|0.58|||<|0.05|TWO_SIDED|90.0|0.49|0.68||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.68|0.49|<0.05
70869620|NCT00042289|141224965|SUPERIORITY||Geometric mean ratio|0.6|||<|0.05|TWO_SIDED|90.0|0.53|0.68||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.68|0.53|<0.05
70869621|NCT00042289|141224966|SUPERIORITY||Geometric mean ratio|0.72||||0.008|TWO_SIDED|90.0|0.6|0.88||3rd Trimester vs. Postpartum|t-test, 2 sided|Paired sample t-test on natural log-transformed PK parameter||||0.88|0.60|0.008
70869622|NCT00042289|141224967|SUPERIORITY||Geometric mean ratio|0.63||||0.002|TWO_SIDED|90.0|0.52|0.75||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.75|0.52|0.002
70869623|NCT00042289|141224967|SUPERIORITY||Geometric mean ratio|0.71||||0.0003|TWO_SIDED|90.0|0.63|0.81||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.81|0.63|0.0003
70869624|NCT00042289|141224967|SUPERIORITY||Geometric mean ratio|0.57||||0.09|TWO_SIDED|90.0|0.34|0.98||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.98|0.34|0.09
70869625|NCT00042289|141224967|SUPERIORITY||Geometric mean ratio|0.67||||0.004|TWO_SIDED|90.0|0.54|0.82||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.82|0.54|0.004
70869626|NCT00042289|141224967|SUPERIORITY||Geometric mean ratio|0.79||||0.27|TWO_SIDED|90.0|0.5|1.27||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.27|0.50|0.27
70869627|NCT00042289|141224967|SUPERIORITY||Geometric mean ratio|0.86||||0.7|TWO_SIDED|90.0|0.66|1.12||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.12|0.66|0.70
70869628|NCT00042289|141224967|SUPERIORITY||Geometric mean ratio|0.62||||0.46|TWO_SIDED|90.0|0.29|1.34||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.34|0.29|0.46
70869629|NCT00042289|141224967|SUPERIORITY||Geometric mean ratio|0.94||||0.5|TWO_SIDED|90.0|0.63|1.39||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.39|0.63|0.50
70869630|NCT00042289|141224967|SUPERIORITY||Geometric mean ratio|0.76|||<|0.1|TWO_SIDED|90.0|0.57|1.0||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.0|0.57|<0.10
70869631|NCT00042289|141224967|SUPERIORITY||Geometric mean ratio|0.56|||<|0.1|TWO_SIDED|90.0|0.42|0.73||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.73|0.42|<0.10
70869632|NCT00042289|141224967|SUPERIORITY||Geometric mean ratio|0.47|||<|0.1|TWO_SIDED|90.0|0.33|0.68||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.68|0.33|<0.10
70869633|NCT00042289|141224967|SUPERIORITY||Geometric mean ratio|0.44|||<|0.1|TWO_SIDED|90.0|0.36|0.54||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.54|0.36|<0.10
70869634|NCT00042289|141224967|SUPERIORITY||Geometric mean ratio|0.74||||0.1875|TWO_SIDED|90.0|0.53|1.04||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.04|0.53|0.1875
70869635|NCT00042289|141224967|SUPERIORITY||Geometric mean ratio|0.46||||0.1563|TWO_SIDED|90.0|0.19|1.11||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.11|0.19|0.1563
70869636|NCT00042289|141224967|SUPERIORITY||Geometric mean ratio|0.94||||0.241|TWO_SIDED|90.0|0.85|1.03||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.03|0.85|0.241
70869637|NCT00042289|141224967|SUPERIORITY||Geometric mean ratio|1.09||||0.837|TWO_SIDED|90.0|0.9|1.32||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.32|0.90|0.837
70869638|NCT00042289|141224967|SUPERIORITY||Geometric mean ratio|0.7|||<|0.05|TWO_SIDED|90.0|0.55|0.88||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||0.88|0.55|<0.05
70869639|NCT00042289|141224967|SUPERIORITY||Geometric mean ratio|0.8||||0.0046|TWO_SIDED|90.0|0.72|0.89||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||0.89|0.72|0.0046
70869640|NCT00042289|141224967|SUPERIORITY||Geometric mean ratio|0.66|||<|0.05|TWO_SIDED|90.0|0.52|0.85||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||0.85|0.52|<0.05
70869641|NCT00042289|141224967|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
70869642|NCT00042289|141224967|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
70869643|NCT00042289|141224967|SUPERIORITY||||||>|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||>0.05
70869644|NCT00042289|141224967|SUPERIORITY||||||>|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||>0.05
70869645|NCT00042289|141224967|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
70869646|NCT00042289|141224967|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
70869647|NCT00042289|141224968|SUPERIORITY||Geometric mean ratio|0.97||||0.07|TWO_SIDED|90.0|0.83|1.13||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.13|0.83|0.07
70869648|NCT00042289|141224968|SUPERIORITY||Geometric mean ratio|0.77|||<|0.05|TWO_SIDED|90.0|0.61|0.96||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.96|0.61|<0.05
71144146|NCT00537394|141781712|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin defined as 15 percentage points. If the confidence interval for the difference in regimen failure between omitting versus adding NRTIs was fully below 15 percentage points, then omitting NRTIs would be concluded to be not inferior to adding NRTIs for this outcome.|Risk Difference (RD)|3.2|||||TWO_SIDED|95.0|-6.1|12.5|||||Endpoint rates with standard errors calculated from Kaplan-Meier curves for each treatment group and stratum. Differences in week 48 failure proportions by treatment calculated weighted by the inverse of the variance in each stratum.|Null Hypothesis was that omitting NRTIs is inferior to adding NRTIs for the outcome of regimen failure through 48 weeks.||12.5|-6.1|
71144147|NCT04267380|141781727|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||||||0.73
71144148|NCT04267380|141781728|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
71144149|NCT04267380|141781729|SUPERIORITY|||||||0.26|||||||Chi-squared|||||||0.26
71144150|NCT04267380|141781730|SUPERIORITY|||||||0.23|||||||Chi-squared|||||||0.23
71144151|NCT04267380|141781731|SUPERIORITY|||||||0.33|||||||Chi-squared|||||||0.33
71144152|NCT04267380|141781732|SUPERIORITY|||||||0.07|||||||Chi-squared|||||||0.07
71144153|NCT04267380|141781733|SUPERIORITY|||||||0.68|||||||Chi-squared|||||||0.68
71144154|NCT04267380|141781734|SUPERIORITY|||||||0.68|||||||Chi-squared|||||||0.68
71144155|NCT04267380|141781736|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||0.45
70869649|NCT00042289|141224968|SUPERIORITY||Geometric mean ratio|0.8|||<|0.05|TWO_SIDED|90.0|0.62|1.03||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.03|0.62|<0.05
71144156|NCT04267380|141781737|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||||||0.53
71144157|NCT04267380|141781738|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|||||||0.86
71144158|NCT04267380|141781739|SUPERIORITY|||||||0.83|||||||t-test, 2 sided|||||||0.83
71144159|NCT04267380|141781740|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
71144160|NCT04267380|141781741|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|||||||0.86
71144161|NCT04267380|141781742|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||||||0.78
71144162|NCT04267380|141781743|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||||||0.99
71144163|NCT04267380|141781744|SUPERIORITY|||||||0.11|||||||Chi-squared|||||||0.11
71144164|NCT04267380|141781745|SUPERIORITY|||||||0.63|||||||Chi-squared|||||||0.63
71144165|NCT04267380|141781746|SUPERIORITY|||||||0.25|||||||Chi-squared|||||||0.25
71144166|NCT00534365|141781793|NON_INFERIORITY_OR_EQUIVALENCE|We chose a non-inferiority margin of 12% based on previously published multicenter trial of mid-urethral slings. Assuming subjective cure rate for TVT of 82%, 127 individuals in each group will provide 80% to reject the null hypothesis that the true difference in cure rates between the two procedures is less than or equal to 2% using a two group large sample normal approximation test of proportions with a one sided 0.05 significance level.||||||0.43|||||||Regression, Logistic|||||||0.43
70869650|NCT00042289|141224969|SUPERIORITY||Geometric mean of ratio|0.81||||0.148|TWO_SIDED|90.0|0.64|1.01||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.01|0.64|0.148
71144167|NCT00534365|141781796|SUPERIORITY_OR_OTHER|||||||0.64|||||||t-test, 2 sided|||||||0.64
71144168|NCT00534365|141781797|SUPERIORITY_OR_OTHER|||||||0.015|||||||t-test, 2 sided|||||||0.015
71144169|NCT04886154|141781815|SUPERIORITY|Superiority was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of samples with bactericidal serum activity is above 5% between the ABCWY low dose\_06 group compared to the Control group at 1 month after the last vaccination.|Difference in percentage|4.67|||||TWO_SIDED|97.5|3.38|5.97|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the superiority of the effectiveness of the MenABCWY-2Gen vaccine (low dose) when administered at 0,6-months schedule, compared to the MenB vaccine administered at 0,6-months schedule.||5.97|3.38|
71144170|NCT04886154|141781815|SUPERIORITY|Superiority was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of samples with bactericidal serum activity is above 5% between the ABCWY low dose\_02 group compared to the Control group at 1 month after the last vaccination.|Difference in percentage|-0.17|||||TWO_SIDED|97.5|-1.65|1.3|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the superiority of the effectiveness of the MenABCWY-2Gen vaccine (low dose) when administered at 0,2- months schedule, compared to the MenB vaccine administered at 0,6-months schedule.||1.30|-1.65|
71144171|NCT04886154|141781815|SUPERIORITY|Superiority was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of samples with bactericidal serum activity is above 5% between the ABCWY high dose\_06 group compared to the Control group at 1 month after the last vaccination.|Difference in percentage|4.6|||||TWO_SIDED|97.5|3.33|5.89|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the superiority of the effectiveness of the MenABCWY-2Gen vaccine (high dose) when administered at 0,6- months schedule, compared to the MenB vaccine administered at 0,6-months schedule.||5.89|3.33|
71144172|NCT04886154|141781815|SUPERIORITY|Superiority was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of samples with bactericidal serum activity is above 5% between the ABCWY high dose\_02 group compared to the Control group at 1 month after the last vaccination.|Difference in percentage|2.01|||||TWO_SIDED|97.5|0.6|3.42|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the superiority of the effectiveness of the MenABCWY-2Gen vaccine (high dose) when administered at 0,2- months schedule, compared to the MenB vaccine administered at 0,6-months schedule.||3.42|0.60|
70869651|NCT00042289|141224969|SUPERIORITY||Geometric mean of ratio|0.71|||<|0.001|TWO_SIDED|90.0|0.62|0.81||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.81|0.62|<0.001
70869652|NCT00042289|141224969|SUPERIORITY||Geometric mean of ratio|0.74||||0.0098|TWO_SIDED|90.0|0.61|0.89||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.89|0.61|0.0098
70869653|NCT00042289|141224969|SUPERIORITY||Geometric mean of ratio|0.75||||0.0025|TWO_SIDED|90.0|0.64|0.88||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.88|0.64|0.0025
70869654|NCT00042289|141224969|SUPERIORITY||Geometric mean of ratio|0.54|||<|0.0001|TWO_SIDED|90.0|0.46|0.64||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.64|0.46|<0.0001
70869655|NCT00042289|141224969|SUPERIORITY||Geometric mean of ratio|0.56||||0.0024|TWO_SIDED|90.0|0.41|0.76||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.76|0.41|0.0024
70869656|NCT00042289|141224969|SUPERIORITY||Geometric mean of ratio|0.795||||0.438|TWO_SIDED|90.0|0.499|1.269||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.269|0.499|0.438
70869657|NCT00042289|141224969|SUPERIORITY||Geometric mean of ratio|0.531||||0.219|TWO_SIDED|90.0|0.186|1.512||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.512|0.186|0.219
70869658|NCT00042289|141224969|SUPERIORITY||Geometric mean of ratio|1.05||||0.296|TWO_SIDED|90.0|0.94|1.18||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.18|0.94|0.296
70869659|NCT00042289|141224969|SUPERIORITY||Geometric mean of ratio|1.26||||0.007|TWO_SIDED|90.0|1.01|1.56||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.56|1.01|0.007
70869660|NCT00042289|141224969|SUPERIORITY||Geometric mean of ratio|0.83||||0.16|TWO_SIDED|90.0|0.56|1.22||2nd Trimester vs Postpartum|Wilcoxon signed rank test|||FPV was analyzed as the form of amprenavir (APV). FPV is the prodrug of APV.||1.22|0.56|0.16
70869661|NCT00042289|141224969|SUPERIORITY||Geometric mean of ratio|0.74||||0.03|TWO_SIDED|90.0|0.58|0.93|||Wilcoxson signed rank test|||FPV was analyzed in the form of amprenavir (APV). FPV is the prodrug of APV.||0.93|0.58|0.03
70869662|NCT00042289|141224969|SUPERIORITY||Geometric mean of ratio|0.86|||>|0.05|TWO_SIDED|90.0|0.68|1.08||3rd Trimester vs. Postpartum (No comparison was done for 2nd Trimester vs. Postpartum since the sample size for 2nd trimester was 1)|Wilcoxon signed rank test|||This analysis was for ATV.||1.08|0.68|>0.05
70952307|NCT04546425|141406017|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|10.3|||||TWO_SIDED|95.0|4.5|16.0|||||2-Sided 95% CI based on the Percent difference for the difference in proportions expressed as a percentage.|Serotype 33F||16.0|4.5|
70869663|NCT00042289|141224969|SUPERIORITY||Geometric mean of ratio|0.89||||0.1636|TWO_SIDED|90.0|0.79|1.01||Third Trimester vs. Postpartum (No comparison was done for Second Trimester vs. Postpartum since only 4 participants had Second Trimester data)|Wilcoxon signed rank test|||||1.01|0.79|0.1636
70869664|NCT00042289|141224969|SUPERIORITY||Geometric mean of ratio|0.69|||<|0.05|TWO_SIDED|90.0|0.53|0.91||3rd Trimester vs Postpartum (No comparison was done for Second Trimester vs. Postpartum since only 4 participants had Second Trimester data)|Wilcoxon signed rank test|||This analysis was for ATV.||0.91|0.53|<0.05
70869665|NCT00042289|141224969|SUPERIORITY||Geometric mean of ratio|1.11||||0.16|TWO_SIDED|90.0|0.99|1.24||3rd Trimester vs. Postpartum (No comparison was done for Second Trimester vs. Postpartum since there was no Second Trimester data available)|Wilcoxon signed rank test|||||1.24|0.99|0.16
70869666|NCT00042289|141224969|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
70869667|NCT00042289|141224969|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
70869668|NCT00042289|141224969|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
70869669|NCT00042289|141224969|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
70869670|NCT00042289|141224969|SUPERIORITY||||||>|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||>0.05
70869671|NCT00042289|141224969|SUPERIORITY||||||>|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||>0.05
70869672|NCT00042289|141224969|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
70869673|NCT00042289|141224969|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
70869674|NCT00042289|141224969|SUPERIORITY||Geometric mean of ratio|1.06||||0.67|TWO_SIDED|90.0|0.85|1.34||3rd Trimester vs. Postpartum (No comparison was done for Second Trimester vs. Postpartum since only 2 participants had Second Trimester data)|Wilcoxon signed-rank test|||||1.34|0.85|0.67
71144173|NCT04886154|141781816|NON_INFERIORITY|Non-inferiority (NI) was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|3.03|||||TWO_SIDED|97.5|-4.21|10.17|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men A).||10.17|-4.21|
70869675|NCT00042289|141224969|SUPERIORITY||Geometric mean of ratio|0.73||||0.08|TWO_SIDED|90.0|0.59|0.91||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.91|0.59|0.08
70869676|NCT00042289|141224969|SUPERIORITY||Geometric mean of ratio|0.63|||<|0.01|TWO_SIDED|90.0|0.55|0.72||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.72|0.55|<0.01
71144174|NCT04886154|141781816|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|4.66|||||TWO_SIDED|97.5|-2.71|11.64|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men A).||11.64|-2.71|
71144175|NCT04886154|141781816|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|5.48|||||TWO_SIDED|97.5|-0.71|12.25|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men A).||12.25|-0.71|
71144176|NCT04886154|141781816|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|3.87|||||TWO_SIDED|97.5|-3.7|10.97|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men A).||10.97|-3.70|
71144177|NCT04886154|141781816|NON_INFERIORITY|Non-inferiority (NI) was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|35.03|||||TWO_SIDED|97.5|25.22|44.75|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men C).||44.75|25.22|
71144178|NCT04886154|141781816|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|34.16|||||TWO_SIDED|97.5|23.76|44.1|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men C).||44.10|23.76|
71144179|NCT04886154|141781816|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|29.88|||||TWO_SIDED|97.5|19.26|40.19|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men C).||40.19|19.26|
70869677|NCT00042289|141224970|SUPERIORITY||Geometric mean of ratio|0.57|||<|0.05|TWO_SIDED|90.0|0.48|0.68||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.68|0.48|<0.05
70869678|NCT00042289|141224970|SUPERIORITY||Geometric mean of ratio|0.73|||<|0.05|TWO_SIDED|90.0|0.62|0.85||3rd Trimester vs.Postpartum|Wilcoxon signed rank test|||||0.85|0.62|<0.05
70869679|NCT00042289|141224970|SUPERIORITY|||||||0.09||||||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||||0.09
70869680|NCT00042289|141224970|SUPERIORITY|||||||0.003||||||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||||0.003
71144180|NCT04886154|141781816|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|33.54|||||TWO_SIDED|97.5|23.09|43.54|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men C).||43.54|23.09|
71144181|NCT04886154|141781816|NON_INFERIORITY|Non-inferiority (NI) was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|30.88|||||TWO_SIDED|97.5|21.61|40.32|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men W).||40.32|21.61|
71144182|NCT04886154|141781816|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the MenABCWY-2Gen MenACWY vaccination in the ABCWY low dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|29.35|||||TWO_SIDED|97.5|19.31|39.08|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men W).||39.08|19.31|
71144183|NCT04886154|141781816|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|29.02|||||TWO_SIDED|97.5|19.42|38.67|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men W).||38.67|19.42|
71144184|NCT04886154|141781816|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|25.13|||||TWO_SIDED|97.5|14.2|35.45|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men W).||35.45|14.20|
71144185|NCT04886154|141781816|NON_INFERIORITY|Non-inferiority (NI) was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|33.38|||||TWO_SIDED|97.5|23.08|43.26|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men Y).||43.26|23.08|
71144186|NCT04886154|141781816|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|28.18|||||TWO_SIDED|97.5|16.61|38.86|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men Y).||38.86|16.61|
71144187|NCT04886154|141781816|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|29.37|||||TWO_SIDED|97.5|18.67|39.63|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men Y).||39.63|18.67|
71144188|NCT04886154|141781816|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|27.21|||||TWO_SIDED|97.5|15.46|38.02|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men Y).||38.02|15.46|
71144189|NCT02099864|141781853|OTHER||Odds Ratio (OR)|10.0||||0.055|TWO_SIDED|95.0|0.9|108.8|||Fisher Exact|Due to sample size, Fisher's exact test was used rather than simple logistic regression.||||108.8|0.9|0.055
71144190|NCT02099864|141781854|OTHER||Odds Ratio (OR)|0.7||||1|TWO_SIDED|95.0|0.1|5.3|||Fisher Exact|Due to sample size, Fisher's exact was used rather than regression.||||5.3|0.1|1.000
70869681|NCT00042289|141224970|SUPERIORITY||Geometric mean of ratio|1.34||||0.036|TWO_SIDED|||||3rd Trimester vs. Postpartum (No comparison was done for Second Trimester vs. Postpartum since only 5 participants had Second Trimester data)|Wilcoxon signed rank test|||||||0.036
70952308|NCT04546425|141406018|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.61|||||TWO_SIDED|95.0|0.54|0.69|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 1||0.69|0.54|
71144191|NCT02099864|141781855|OTHER||Odds Ratio (OR)|0.7||||1|TWO_SIDED|95.0|0.0|17.0|||Fisher Exact|||||17.0|0.0|1.000
71144192|NCT02099864|141781856|OTHER||Median Difference (Final Values)|23.2||||0.84|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Difference is the median for responders minus the median for non-responders.|||||0.84
70869682|NCT00042289|141224970|SUPERIORITY||Geometric mean of ratio|0.84|||>|0.05|TWO_SIDED|90.0|0.69|1.02||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.02|0.69|>0.05
70869683|NCT00042289|141224970|SUPERIORITY||Geometric mean of ratio|0.83|||>|0.05|TWO_SIDED|90.0|0.68|1.01||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.01|0.68|>0.05
71144193|NCT02099864|141781857|OTHER||Median Difference (Final Values)|-1.9||||0.14|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Difference is the median for responders minus the median for non-responders.|||||0.14
71144194|NCT02099864|141781858|OTHER||Odds Ratio (OR)|2.7||||1|TWO_SIDED|95.0|0.1|60.2|||Fisher Exact|||||60.2|0.1|1.00
71144195|NCT02099864|141781860|OTHER||Median Difference (Final Values)|4.8||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Difference is the median for the responders minus the median for the non-responders.|||||0.01
71144196|NCT02099864|141781863|OTHER||Hazard Ratio (HR)|0.18|||<|0.001|TWO_SIDED|95.0|0.07|0.45|||Regression, Cox|||||0.45|0.07|<0.001
71144197|NCT02099864|141781864|OTHER||Hazard Ratio (HR)|0.22||||0.002|TWO_SIDED|95.0|0.08|0.56|||Regression, Cox|||||0.56|0.08|0.002
70869684|NCT00042289|141224971|SUPERIORITY||Geometric mean of ratio|0.61||||0.14|TWO_SIDED|90.0|0.34|1.09||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.09|0.34|0.14
70869685|NCT00042289|141224971|SUPERIORITY||Geometric mean of ratio|0.64||||0.002|TWO_SIDED|90.0|0.5|0.81||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.81|0.50|0.002
70869686|NCT00042289|141224971|SUPERIORITY||Geometric mean of ratio|0.77||||0.24|TWO_SIDED|90.0|0.49|1.23||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.23|0.49|0.24
70952309|NCT04546425|141406018|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.71|||||TWO_SIDED|95.0|0.64|0.79|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 3||0.79|0.64|
70952310|NCT04546425|141406018|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.6|||||TWO_SIDED|95.0|0.52|0.69|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 4||0.69|0.52|
71144198|NCT02099864|141781865|OTHER||Hazard Ratio (HR)|0.23||||0.23|TWO_SIDED|95.0|0.02|0.59|||Regression, Cox|||||0.59|0.02|0.23
71144199|NCT02099864|141781866|OTHER||Hazard Ratio (HR)|0.18|||<|0.001|TWO_SIDED|95.0|0.07|0.45|||Regression, Cox|||||0.45|0.07|<0.001
71144200|NCT02099864|141781871|OTHER||Hazard Ratio (HR)|4.9|||<|0.001|TWO_SIDED|95.0|2.03|11.82|||Regression, Cox|||||11.82|2.03|<0.001
71144201|NCT00179621|141781906|SUPERIORITY_OR_OTHER||||||<|0.001||||||To compare the response rates of Lenalidomide 5 mg QD vs. placebo, the Hochberg procedure was used to control the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Stratified by International Prognostic Scoring System (IPSS) score (IPSS combined score =0 versus \>0) to compare lenalidomide treatment with placebo.||||||<0.001
71144202|NCT00179621|141781906|SUPERIORITY_OR_OTHER||||||<|0.001||||||To compare the response rates of Lenalidomide 10 mg QD vs. placebo, the Hochberg procedure was used to control the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Stratified by International Prognostic Scoring System (IPSS) score (IPSS combined score =0 versus \>0) to compare lenalidomide treatment with placebo.||||||<0.001
71144203|NCT00179621|141781907|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by International Prognostic Scoring System (IPSS) score (IPSS combined score =0 versus \>0) to compare lenalidomide treatment with placebo.||||||<0.001
71144204|NCT00179621|141781907|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by International Prognostic Scoring System (IPSS) score (IPSS combined score =0 versus \>0) to compare lenalidomide treatment with placebo.||||||<0.001
71144205|NCT00179621|141781917|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
71144206|NCT00179621|141781917|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
71144207|NCT00179621|141781918|SUPERIORITY_OR_OTHER|||||||0.054||95.0|||||ANOVA|||||||0.054
71144208|NCT00179621|141781918|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANOVA|||||||0.080
71144209|NCT00179621|141781919|SUPERIORITY_OR_OTHER|||||||0.062||95.0|||||ANOVA|||||||0.062
71144210|NCT00179621|141781919|SUPERIORITY_OR_OTHER|||||||0.113||95.0|||||ANOVA|||||||0.113
71144211|NCT02973100|141781933|SUPERIORITY||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.07|-0.53|||Mixed Models Analysis|||||-0.53|-1.07|<.001
71144212|NCT02973100|141781933|SUPERIORITY||Mean Difference (Final Values)|-0.87|||<|0.001|TWO_SIDED|95.0|-1.14|-0.6|||Mixed Models Analysis|||||-0.60|-1.14|<0.001
71144213|NCT02973100|141781933|SUPERIORITY||Mean Difference (Final Values)|-0.96|||<|0.001|TWO_SIDED|95.0|-1.24|-0.69|||Mixed Models Analysis|||||-0.69|-1.24|<.001
71144214|NCT02973100|141781934|SUPERIORITY||Odds Ratio (OR)|24.489|||<|0.001|TWO_SIDED|95.0|8.368|71.667|||Regression, Logistic|||||71.667|8.368|<.001
71144215|NCT02973100|141781934|SUPERIORITY||Odds Ratio (OR)|27.906|||<|0.001|TWO_SIDED|95.0|9.238|84.3|||Regression, Logistic|||||84.300|9.238|<.001
71144216|NCT02973100|141781934|SUPERIORITY||Odds Ratio (OR)|21.852|||<|0.001|TWO_SIDED|95.0|7.672|62.242|||Regression, Logistic|||||62.242|7.672|<.001
71144217|NCT02973100|141781935|SUPERIORITY||Mean Difference (Final Values)|-1.32|||<|0.001|TWO_SIDED|95.0|-2.02|-0.62|||Mixed Models Analysis|||||-0.62|-2.02|<0.001
70869687|NCT00042289|141224971|SUPERIORITY||Geometric mean of ratio|0.84||||0.53|TWO_SIDED|90.0|0.6|1.17||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.17|0.60|0.53
71144218|NCT02973100|141781935|SUPERIORITY||Mean Difference (Final Values)|-1.23|||<|0.001|TWO_SIDED|95.0|-1.91|-0.54|||Mixed Models Analysis|||||-0.54|-1.91|<0.001
71144219|NCT02973100|141781935|SUPERIORITY||Mean Difference (Final Values)|-1.42|||<|0.001|TWO_SIDED|95.0|-2.12|-0.72|||Mixed Models Analysis|||||-0.72|-2.12|<0.001
71144220|NCT02973100|141781936|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.025|TWO_SIDED|95.0|-2.3|-0.2|||Mixed Models Analysis|||||-0.2|-2.3|0.025
71144221|NCT02973100|141781936|SUPERIORITY||Mean Difference (Final Values)|-2.4|||<|0.001|TWO_SIDED|95.0|-3.4|-1.3|||Mixed Models Analysis|||||-1.3|-3.4|<0.001
71144222|NCT02973100|141781936|SUPERIORITY||Mean Difference (Final Values)|-2.6|||<|0.001|TWO_SIDED|95.0|-3.7|-1.5|||Mixed Models Analysis|||||-1.5|-3.7|<0.001
71144223|NCT00960622|141781941|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_DEVIATION|8.5|<|0.05|TWO_SIDED|95.0|-6.3|11.3|||t-test, 2 sided|||"Paired t-tests for inter-group differences between baseline and end-of-study measurements.Regression analysis, physiological correlates of statistically significant between-group changes.~P\<0.05 chosen for statistical significance"||11.3|-6.3|<0.05
71144224|NCT01841281|141781949|OTHER|||||||0.78||||||The p-value is for the interaction term|testing for interaction term|||||||0.78
71144225|NCT01841281|141781950|OTHER|||||||0.09||||||The p-value is for the interaction term|testing for interaction term|||The treatment effect was tested as an interaction term between treatment and FeNO. The null hypothesis is the effect of treatment is stratified by the FeNO status. We used a regression model instead of t-test or Wilcoxon signed-rank test in order to control period and carry-over effect which is common in a cross-over study design||||0.09
70869688|NCT00042289|141224971|SUPERIORITY||Geometric mean of ratio|0.58||||0.2|TWO_SIDED|90.0|0.3|1.11||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.11|0.30|0.2
70869689|NCT00042289|141224971|SUPERIORITY||Geometric mean of ratio|0.95||||0.12|TWO_SIDED|90.0|0.58|1.55||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.55|0.58|0.12
70869690|NCT00042289|141224971|SUPERIORITY||Geometric mean of ratio|0.92||||0.358|TWO_SIDED|90.0|0.71|1.2||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.2|0.71|0.358
71144226|NCT04516746|141781953|SUPERIORITY||Vaccine efficacy|73.98|||<|0.001|TWO_SIDED|95.0|65.34|80.47|||Poisson regression with robust variance|||The 95% confidence interval (CI) and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor \[age group at informed consent\] as covariates, and log of the follow up time as an offset).||80.47|65.34|<0.001
71144227|NCT04516746|141781957|SUPERIORITY||Vaccine efficacy|64.32|||<|0.001|TWO_SIDED|95.0|56.05|71.03|||Poisson regression with robust variance|||The 95% CI and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor \[age group at informed consent\] as covariates, and log of the follow up time as an offset).||71.03|56.05|<0.001
71144228|NCT04516746|141781958|SUPERIORITY||Vaccine efficacy|69.65|||<|0.001|TWO_SIDED|95.0|60.68|76.57|||Poisson regression with robust variance|||The 95% CI and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor \[age group at informed consent\] as covariates, and log of the follow up time as an offset).||76.57|60.68|<0.001
71144229|NCT04516746|141781959|SUPERIORITY||Vaccine efficacy|70.7|||<|0.001|TWO_SIDED|95.0|61.62|77.64|||Poisson regression with robust variance|||The 95% CI and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor \[age group at informed consent\] as covariates, and log of the follow up time as an offset).||77.64|61.62|<0.001
71144230|NCT04516746|141781960|SUPERIORITY||Vaccine efficacy|73.68|||<|0.001|TWO_SIDED|95.0|65.13|80.13|||Poisson regression with robust variance|||The 95% CI and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor \[age group at informed consent\] as covariates, and log of the follow up time as an offset).||80.13|65.13|<0.001
71144231|NCT04516746|141781961|SUPERIORITY||Vaccine efficacy|100.0|||<|0.001|ONE_SIDED|97.5|71.62||||Poisson regression exact conditional|||The exact 1-sided 97.5% CI and p-value were estimated based on stratified Poisson regression with exact conditional method (including study arm and stratification factor \[age group at informed consent\] as strata factor and log of total number of participants for each combination of study arm and strata as an offset).|||71.62|<0.001
71144232|NCT04516746|141781962|SUPERIORITY||Vaccine efficacy|84.97|||<|0.001|TWO_SIDED|95.0|58.97|94.5|||Poisson regression with robust variance|||The 95% CI were estimated based on Poisson regression with robust variance (including study arm and age group at screening (18-65 years, ≥ 65 years) as covariates and log of the follow-up time as an offset).||94.50|58.97|<0.001
71144233|NCT04516746|141781963|SUPERIORITY||Vaccine efficacy|94.8||||0.005|TWO_SIDED|95.0|58.98|99.34|||Poisson regression with robust variance|||The 95% CI and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor \[age group at informed consent\] as covariates, and log of the follow up time as an offset).||99.34|58.98|0.005
71144234|NCT04516746|141781970|SUPERIORITY||Vaccine efficacy|54.47|||||TWO_SIDED|95.0|46.48|61.26||||||The 95% CI were estimated based on Poisson regression with robust variance (including study arm and age group at screening (18-65 years, ≥ 65 years) as covariates and log of the follow-up time as an offset).||61.26|46.48|
71144235|NCT04231669|141781995|SUPERIORITY|||||||0.05|||||||Linear Mixed-effects regression|||||||0.05
71144236|NCT05543265|141782010|SUPERIORITY||Mean Difference (Final Values)|22.0|||<|0.001|TWO_SIDED|95.0|6.4|28.8|||Chi-squared|||||28.8|6.4|<0.001
71144237|NCT05316597|141782038|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.914|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.914
71144238|NCT05316597|141782039|SUPERIORITY||Mean Difference (Final Values)|1.13||||0.554|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||.554
71144239|NCT05316597|141782040|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.905|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|||||||0.905
71144240|NCT05316597|141782041|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.076|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.076
71144241|NCT05316597|141782041|SUPERIORITY|||||||0.02||||||Threshold of P \< 0.05 for significance. ANCOVA results of comparing reduced vs. full model over time.|ANOVA|||Exploratory ANOVA results comparing full and reduced models to test the effect of terpene exposure on pattern of outcome over time.||||0.02
71144242|NCT05316597|141782042|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.21|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.210
71144243|NCT05316597|141782042|SUPERIORITY|||||||0.57||||||Threshold of P \< 0.05 for significance. ANCOVA results of comparing reduced vs. full model over time.|ANOVA|||Exploratory ANOVA results comparing full and reduced models to test the effect of terpene exposure on pattern of outcome over time.||||0.57
71144244|NCT05316597|141782043|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.921|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.921
71144245|NCT05316597|141782043|SUPERIORITY|||||||0.82||||||Threshold of P \< 0.05 for significance. ANCOVA results of comparing reduced vs. full model over time.|ANOVA|||||||0.82
71144246|NCT05316597|141782044|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.265|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.265
71144247|NCT05316597|141782044|SUPERIORITY|||||||0.63||||||Threshold of P \< 0.05 for significance. ANCOVA results of comparing reduced vs. full model over time.|ANOVA|||||||0.63
71144248|NCT05316597|141782045|SUPERIORITY||Median Difference (Final Values)|-0.34||||0.724|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.724
70952311|NCT04546425|141406018|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.6|||||TWO_SIDED|95.0|0.52|0.7|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 5||0.70|0.52|
70952312|NCT04546425|141406018|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.54|||||TWO_SIDED|95.0|0.45|0.65|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 6A||0.65|0.45|
70952313|NCT04546425|141406018|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.51|||||TWO_SIDED|95.0|0.43|0.61|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 6B||0.61|0.43|
70952314|NCT04546425|141406018|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.72|||||TWO_SIDED|95.0|0.64|0.8|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 7F||0.80|0.64|
70952315|NCT04546425|141406018|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.59|||||TWO_SIDED|95.0|0.5|0.69|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 9V||0.69|0.50|
70869691|NCT00042289|141224971|SUPERIORITY||Geometric mean of ratio|0.72||||0.0156|TWO_SIDED|90.0|0.55|0.93||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.93|0.55|0.0156
70952316|NCT04546425|141406018|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.82|||||TWO_SIDED|95.0|0.7|0.96|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 14||0.96|0.70|
70869692|NCT00042289|141224972|SUPERIORITY||Geometric mean of ratio|0.7||||0.007|TWO_SIDED|90.0|0.58|0.85||3rd Trimester vs. Postpartum (No comparison was done for Second Trimester vs. Postpartum since no Second Trimester data was available)|Wilcoxon signed rank test|||||0.85|0.58|0.007
70869693|NCT00042289|141224973|SUPERIORITY||Geometric mean ratio|0.66||||0.109|TWO_SIDED|90.0|0.39|1.12||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.12|0.39|0.109
70952317|NCT04546425|141406018|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.79|||||TWO_SIDED|95.0|0.67|0.92|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 18C||0.92|0.67|
70952318|NCT04546425|141406018|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.59|||||TWO_SIDED|95.0|0.51|0.69|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 19A||0.69|0.51|
70869694|NCT00042289|141224973|SUPERIORITY||Geometric mean ratio|0.58|||<|0.001|TWO_SIDED|90.0|0.49|0.69||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.69|0.49|<0.001
70952319|NCT04546425|141406018|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.72|||||TWO_SIDED|95.0|0.64|0.82|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 19F||0.82|0.64|
70952320|NCT04546425|141406018|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.52|||||TWO_SIDED|95.0|0.44|0.62|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 23F||0.62|0.44|
70952321|NCT04546425|141406018|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|26.55|||||TWO_SIDED|95.0|22.98|30.67|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 8||30.67|22.98|
70952322|NCT04546425|141406018|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|2.67|||||TWO_SIDED|95.0|2.25|3.17|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 10A||3.17|2.25|
70952323|NCT04546425|141406018|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|26.6|||||TWO_SIDED|95.0|22.95|30.82|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 11A||30.82|22.95|
70952324|NCT04546425|141406018|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|2.48|||||TWO_SIDED|95.0|2.08|2.97|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 12F||2.97|2.08|
70952325|NCT04546425|141406018|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|54.6|||||TWO_SIDED|95.0|46.35|64.3|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 15B||64.30|46.35|
70952326|NCT04546425|141406018|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|36.8|||||TWO_SIDED|95.0|31.57|42.89|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 22F||42.89|31.57|
70952327|NCT04546425|141406018|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|5.03|||||TWO_SIDED|95.0|4.27|5.92|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 33F||5.92|4.27|
70952328|NCT04546425|141406019|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.67|||||TWO_SIDED|95.0|0.6|0.75|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 1||0.75|0.60|
70952329|NCT04546425|141406019|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.66|||||TWO_SIDED|95.0|0.59|0.73|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 3||0.73|0.59|
70952330|NCT04546425|141406019|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.77|||||TWO_SIDED|95.0|0.68|0.87|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 4||0.87|0.68|
70952331|NCT04546425|141406019|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.72|||||TWO_SIDED|95.0|0.64|0.81|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 5||0.81|0.64|
70952332|NCT04546425|141406019|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.66|||||TWO_SIDED|95.0|0.57|0.75|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 6A||0.75|0.57|
70952333|NCT04546425|141406019|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.57|||||TWO_SIDED|95.0|0.48|0.67|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 6B||0.67|0.48|
70952334|NCT04546425|141406019|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.73|||||TWO_SIDED|95.0|0.67|0.8|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 7F||0.80|0.67|
70952335|NCT04546425|141406019|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.73|||||TWO_SIDED|95.0|0.66|0.81|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 9V||0.81|0.66|
70952336|NCT04546425|141406019|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.8|||||TWO_SIDED|95.0|0.69|0.92|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 14||0.92|0.69|
70952337|NCT04546425|141406019|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.75|||||TWO_SIDED|95.0|0.67|0.84|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 18C||0.84|0.67|
70952338|NCT04546425|141406019|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.82|||||TWO_SIDED|95.0|0.72|0.93|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 19A||0.93|0.72|
71144249|NCT05316597|141782046|SUPERIORITY||Mean Difference (Final Values)|-2.85||||0.716|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.716
71144250|NCT05316597|141782047|SUPERIORITY||Mean Difference (Final Values)|-0.53||||0.852|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.852
71144251|NCT05316597|141782048|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.166|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.166
71144252|NCT05316597|141782049|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.046|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.046
71144253|NCT05526716|141782066|NON_INFERIORITY|Serotype 3|Geometric Mean Titers Ratio (GMT Ratio)|0.84|||||TWO_SIDED|95.0|0.72|0.97||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.97|0.72|
70952339|NCT04546425|141406019|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.77|||||TWO_SIDED|95.0|0.68|0.87|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 19F||0.87|0.68|
71144254|NCT05526716|141782066|NON_INFERIORITY|Serotype 6A|GMT Ratio|0.79|||||TWO_SIDED|95.0|0.66|0.94||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.94|0.66|
71144255|NCT05526716|141782066|NON_INFERIORITY|Serotype 7F|GMT Ratio|0.73|||||TWO_SIDED|95.0|0.63|0.85||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.85|0.63|
71144256|NCT05526716|141782066|NON_INFERIORITY|Serotype 8|GMT Ratio|0.71|||||TWO_SIDED|95.0|0.61|0.82||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.82|0.61|
71144257|NCT05526716|141782066|NON_INFERIORITY|Serotype 9N|GMT Ratio|0.67|||||TWO_SIDED|95.0|0.57|0.79||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.79|0.57|
71144258|NCT05526716|141782066|NON_INFERIORITY|Serotype 10A|GMT Ratio|0.76|||||TWO_SIDED|95.0|0.65|0.91||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.91|0.65|
71144259|NCT05526716|141782066|NON_INFERIORITY|Serotype 11A|GMT Ratio|0.64|||||TWO_SIDED|95.0|0.54|0.75||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.75|0.54|
71144260|NCT05526716|141782066|NON_INFERIORITY|Serotype 12F|GMT Ratio|0.76|||||TWO_SIDED|95.0|0.62|0.94||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.94|0.62|
71144261|NCT05526716|141782066|NON_INFERIORITY|Serotype 15A|GMT Ratio|0.71|||||TWO_SIDED|95.0|0.6|0.85||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.85|0.60|
71144262|NCT05526716|141782066|NON_INFERIORITY|Serotype 15C|GMT Ratio|0.71|||||TWO_SIDED|95.0|0.58|0.87||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.87|0.58|
71144263|NCT05526716|141782066|NON_INFERIORITY|Serotype 16F|GMT Ratio|0.69|||||TWO_SIDED|95.0|0.59|0.81||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.81|0.59|
71144264|NCT05526716|141782066|NON_INFERIORITY|Serotype 17F|GMT Ratio|0.73|||||TWO_SIDED|95.0|0.62|0.86||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.86|0.62|
71144265|NCT05526716|141782066|NON_INFERIORITY|Serotype 19A|GMT Ratio|0.75|||||TWO_SIDED|95.0|0.65|0.85||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.85|0.65|
71144266|NCT05526716|141782066|NON_INFERIORITY|Serotype 20A|GMT Ratio|0.74|||||TWO_SIDED|95.0|0.63|0.87||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.87|0.63|
71144267|NCT05526716|141782066|NON_INFERIORITY|Serotype 22F|GMT Ratio|0.77|||||TWO_SIDED|95.0|0.65|0.91||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.91|0.65|
71144268|NCT05526716|141782066|NON_INFERIORITY|Serotype 23A|GMT Ratio|0.78|||||TWO_SIDED|95.0|0.63|0.96||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.96|0.63|
71144269|NCT05526716|141782066|NON_INFERIORITY|Serotype 23B|GMT Ratio|0.56|||||TWO_SIDED|95.0|0.44|0.72||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.72|0.44|
71144270|NCT05526716|141782066|NON_INFERIORITY|Serotype 24F|GMT Ratio|0.72|||||TWO_SIDED|95.0|0.61|0.86||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.86|0.61|
71144271|NCT05526716|141782066|NON_INFERIORITY|Serotype 31|GMT Ratio|0.68|||||TWO_SIDED|95.0|0.56|0.83||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.83|0.56|
71144272|NCT05526716|141782066|NON_INFERIORITY|Serotype 33F|GMT Ratio|0.84|||||TWO_SIDED|95.0|0.7|1.01||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||1.01|0.70|
71144273|NCT05526716|141782066|NON_INFERIORITY|Serotype 35B|GMT Ratio|0.77|||||TWO_SIDED|95.0|0.67|0.89||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of serotypes is \>0.50.||0.89|0.67|
71144274|NCT05526716|141782067|NON_INFERIORITY|A/H1N1|GMT Ratio|0.83|||||TWO_SIDED|95.0|0.7|0.97||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the HAI GMT ratio (GMTcon/GMTseq) for each of the strains is \>0.67.||0.97|0.70|
71144275|NCT05526716|141782067|NON_INFERIORITY|A/H3N2|GMT Ratio|0.79|||||TWO_SIDED|95.0|0.67|0.93||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the HAI GMT ratio (GMTcon/GMTseq) for each of the strains is \>0.67.||0.93|0.67|
70952340|NCT04546425|141406019|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.6|||||TWO_SIDED|95.0|0.52|0.69|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 23F||0.69|0.52|
70952341|NCT04546425|141406019|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.48|||||TWO_SIDED|95.0|1.32|1.66|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 8||1.66|1.32|
70952342|NCT04546425|141406019|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|2.02|||||TWO_SIDED|95.0|1.77|2.3|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 10A||2.30|1.77|
70952343|NCT04546425|141406019|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.55|||||TWO_SIDED|95.0|1.37|1.75|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 11A||1.75|1.37|
70952344|NCT04546425|141406019|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.77|||||TWO_SIDED|95.0|0.68|0.87|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 12F||0.87|0.68|
70952345|NCT04546425|141406019|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|5.42|||||TWO_SIDED|95.0|4.82|6.1|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 15B||6.10|4.82|
70952346|NCT04546425|141406019|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|3.84|||||TWO_SIDED|95.0|3.4|4.34|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 22F||4.34|3.40|
70952347|NCT04546425|141406019|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|2.64|||||TWO_SIDED|95.0|2.33|2.99|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 33F||2.99|2.33|
70952348|NCT04546425|141406020|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC -13vPnC) was greater than -10%.|Percent difference|-0.2|||||TWO_SIDED|95.0|-1.3|0.8|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Diphtheria||0.8|-1.3|
70952349|NCT04546425|141406020|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|-0.6|||||TWO_SIDED|95.0|-1.8|0.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Tetanus||0.2|-1.8|
70952350|NCT04546425|141406020|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|-2.3|||||TWO_SIDED|95.0|-5.3|0.7|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|PT||0.7|-5.3|
70952351|NCT04546425|141406020|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|0.2|||||TWO_SIDED|95.0|-2.6|2.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|FHA||2.9|-2.6|
70952352|NCT04546425|141406020|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|1.6|||||TWO_SIDED|95.0|-0.9|4.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|PRN||4.2|-0.9|
70952353|NCT04546425|141406020|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|1.1|||||TWO_SIDED|95.0|-1.1|4.0|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Hepatitis B||4.0|-1.1|
70952354|NCT04546425|141406020|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC -13vPnC) was greater than -10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-4.6|4.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Poliovirus Type 1||4.2|-4.6|
70952355|NCT04546425|141406020|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-4.6|4.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Poliovirus Type 2||4.2|-4.6|
70952356|NCT04546425|141406020|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-4.6|4.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Poliovirus Type 3||4.2|-4.6|
70952357|NCT04546425|141406020|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.0|2.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Hib||2.2|-2.0|
70952358|NCT04546425|141406021|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.05|||||TWO_SIDED|95.0|0.79|1.42|||||GMR and 2-sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the concentrations (20vPnC - 13vPnC) and the corresponding CIs (based on the Student's t distribution).|Measles||1.42|0.79|
70952359|NCT04546425|141406022|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.04|||||TWO_SIDED|95.0|0.76|1.44|||||GMR and 2-sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the concentrations (20vPnC - 13vPnC) and the corresponding CIs (based on the Student's t distribution).|Mumps||1.44|0.76|
70952360|NCT04546425|141406023|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.83|||||TWO_SIDED|95.0|0.63|1.1|||||GMR and 2-sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the concentrations (20vPnC - 13vPnC) and the corresponding CIs (based on the Student's t distribution).|Rubella||1.10|0.63|
70952361|NCT04546425|141406024|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.24|||||TWO_SIDED|95.0|0.98|1.57|||||GMR and 2-sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the concentrations (20vPnC - 13vPnC) and the corresponding CIs (based on the Student's t distribution).|Varicella||1.57|0.98|
70952362|NCT04546425|141406038|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|-1.0|||||TWO_SIDED|95.0|-3.1|0.9|||||2-Sided 95% CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.|Serotype 1 \\||0.9|-3.1|
70952363|NCT04546425|141406038|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|-10.6|||||TWO_SIDED|95.0|-14.7|-6.7|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 3||-6.7|-14.7|
70952364|NCT04546425|141406038|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.4|1.3|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 4||1.3|-1.4|
70952365|NCT04546425|141406038|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.4|||||TWO_SIDED|95.0|-1.4|2.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 5||2.2|-1.4|
70952366|NCT04546425|141406038|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.6|1.5|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 6A||1.5|-1.6|
70952367|NCT04546425|141406038|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.8|||||TWO_SIDED|95.0|-1.1|2.7|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 6B||2.7|-1.1|
70952368|NCT04546425|141406038|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|-0.4|||||TWO_SIDED|95.0|-1.5|0.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 7F||0.4|-1.5|
70952369|NCT04546425|141406038|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.4|||||TWO_SIDED|95.0|-1.0|1.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 9V||1.9|-1.0|
70952370|NCT04546425|141406038|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|-1.5|||||TWO_SIDED|95.0|-3.7|0.6|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 14||0.6|-3.7|
70952371|NCT04546425|141406038|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|1.0|||||TWO_SIDED|95.0|-0.5|2.7|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 18C||2.7|-0.5|
70952372|NCT04546425|141406038|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 19A||1.1|-1.1|
70952373|NCT04546425|141406038|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.2|||||TWO_SIDED|95.0|-0.9|1.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 19F||1.4|-0.9|
70952374|NCT04546425|141406038|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|-0.9|||||TWO_SIDED|95.0|-3.2|1.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 23F||1.4|-3.2|
70869695|NCT00042289|141224973|SUPERIORITY||Geometric mean ratio|0.48||||0.44|TWO_SIDED|90.0|0.14|1.65||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.65|0.14|0.44
70952375|NCT04546425|141406038|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F(13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|2.0|||||TWO_SIDED|95.0|0.4|3.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 8||3.9|0.4|
70952376|NCT04546425|141406038|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F(13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|0.6|||||TWO_SIDED|95.0|-1.5|2.7|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 10A||2.7|-1.5|
70952377|NCT04546425|141406038|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|1.2|||||TWO_SIDED|95.0|-0.7|3.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 11A||3.2|-0.7|
70952378|NCT04546425|141406038|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|-0.6|||||TWO_SIDED|95.0|-2.9|1.6|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 12F||1.6|-2.9|
70869696|NCT00042289|141224973|SUPERIORITY||Geometric mean ratio|0.56|||<|0.001|TWO_SIDED|90.0|0.43|0.72||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.72|0.43|<0.001
70869697|NCT00042289|141224973|SUPERIORITY||Geometric mean ratio|0.83||||0.43|TWO_SIDED|90.0|0.63|1.1||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.10|0.63|0.43
70869698|NCT00042289|141224973|SUPERIORITY||Geometric mean ratio|1.0||||0.31|TWO_SIDED|90.0|0.69|1.44||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.44|0.69|0.31
71144276|NCT05526716|141782067|NON_INFERIORITY|B/Victoria|GMT Ratio|0.82|||||TWO_SIDED|95.0|0.7|0.95||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the HAI GMT ratio (GMTcon/GMTseq) for each of the strains is \>0.67.||0.95|0.70|
71144277|NCT05526716|141782067|NON_INFERIORITY|B/Yamagata|GMT Ratio|0.89|||||TWO_SIDED|95.0|0.78|1.0||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the HAI GMT ratio (GMTcon/GMTseq) for each of the strains is \>0.67.||1.00|0.78|
71144278|NCT05526716|141782068|OTHER|Serotype 3|GMC Ratio|0.9|||||TWO_SIDED|95.0|0.8|1.02||||||||1.02|0.80|
71144279|NCT05526716|141782068|OTHER|Serotype 6A|GMC Ratio|0.93|||||TWO_SIDED|95.0|0.79|1.11||||||||1.11|0.79|
71144280|NCT05526716|141782068|OTHER|Serotype 7F|GMC Ratio|0.78|||||TWO_SIDED|95.0|0.67|0.9||||||||0.90|0.67|
71144281|NCT05526716|141782068|OTHER|Serotype 8|GMC Ratio|0.82|||||TWO_SIDED|95.0|0.7|0.95||||||||0.95|0.70|
71144282|NCT05526716|141782068|OTHER|Serotype 9N|GMC Ratio|0.88|||||TWO_SIDED|95.0|0.75|1.05||||||||1.05|0.75|
71144283|NCT05526716|141782068|OTHER|Serotype 10A|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.67|0.94||||||||0.94|0.67|
71144284|NCT05526716|141782068|OTHER|Serotype 11A|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.72|0.96||||||||0.96|0.72|
71144285|NCT05526716|141782068|OTHER|Serotype 12F|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.69|1.01||||||||1.01|0.69|
71144286|NCT05526716|141782068|OTHER|Serotype 15A|GMC Ratio|0.75|||||TWO_SIDED|95.0|0.63|0.9||||||||0.90|0.63|
71144287|NCT05526716|141782068|OTHER|Serotype 15C|GMC Ratio|0.85|||||TWO_SIDED|95.0|0.71|1.02||||||||1.02|0.71|
71144288|NCT05526716|141782068|OTHER|Serotype 16F|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.7|0.99||||||||0.99|0.70|
71144289|NCT05526716|141782068|OTHER|Serotype 17F|GMC Ratio|0.85|||||TWO_SIDED|95.0|0.72|0.99||||||||0.99|0.72|
71144290|NCT05526716|141782068|OTHER|Serotype 19A|GMC Ratio|0.81|||||TWO_SIDED|95.0|0.71|0.93||||||||0.93|0.71|
71144291|NCT05526716|141782068|OTHER|Serotype 20A|GMC Ratio|0.82|||||TWO_SIDED|95.0|0.7|0.97||||||||0.97|0.70|
71144292|NCT05526716|141782068|OTHER|Serotype 22F|GMC Ratio|0.94|||||TWO_SIDED|95.0|0.8|1.1||||||||1.10|0.80|
71144293|NCT05526716|141782068|OTHER|Serotype 23A|GMC Ratio|0.85|||||TWO_SIDED|95.0|0.7|1.03||||||||1.03|0.70|
71144294|NCT05526716|141782068|OTHER|Serotype 23B|GMC Ratio|0.86|||||TWO_SIDED|95.0|0.72|1.02||||||||1.02|0.72|
71144295|NCT05526716|141782068|OTHER|Serotype 24F|GMC Ratio|0.85|||||TWO_SIDED|95.0|0.69|1.05||||||||1.05|0.69|
71144296|NCT05526716|141782068|OTHER|Serotype 31|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.72|0.99||||||||0.99|0.72|
71144297|NCT05526716|141782068|OTHER|Serotype 33F|GMC Ratio|0.81|||||TWO_SIDED|95.0|0.69|0.94||||||||0.94|0.69|
71144298|NCT05526716|141782068|OTHER|Serotype 35B|GMC Ratio|0.85|||||TWO_SIDED|95.0|0.72|0.99||||||||0.99|0.72|
71144299|NCT03547518|141782091|SUPERIORITY|||||||0.111|||||||t-test, 2 sided|||||||0.111
71144300|NCT03547518|141782092|SUPERIORITY|||||||0.487|||||||t-test, 2 sided|||||||0.487
71144301|NCT03547518|141782093|SUPERIORITY|||||||0.0393|||||||t-test, 2 sided|||||||0.0393
71144302|NCT03547518|141782094|SUPERIORITY|||||||0.242|||||||t-test, 2 sided|||||||0.242
71144303|NCT03547518|141782095|SUPERIORITY|||||||0.855|||||||t-test, 2 sided|||||||0.855
71144304|NCT04742556|141782103|OTHER||Probability of true DLT rate in [0.33-1]|0.0051||||||||||||||Probability of true DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
71144305|NCT04742556|141782103|OTHER||Probability of true DLT rate in [0.33-1]|0.03105||||||||||||||Probability of true DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
71144306|NCT04742556|141782103|OTHER||Probability of true DLT rate in [0.33-1]|0.27405||||||||||||||Probability of true DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
71144307|NCT02201524|141782124|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-5.08|STANDARD_ERROR_OF_MEAN|2.42|||TWO_SIDED|90.0|-9.15|-1.01||||||PF-04965842 200 mg vs Placebo: Longitudinal analysis of covariance (LANCOVA) model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-1.01|-9.15|
71144308|NCT02201524|141782124|SUPERIORITY_OR_OTHER||LS mean difference|-5.61|STANDARD_ERROR_OF_MEAN|2.375|||TWO_SIDED|90.0|-9.61|-1.62||||||PF-04965842 400 mg vs Placebo: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-1.62|-9.61|
71144309|NCT02201524|141782124|SUPERIORITY_OR_OTHER||LS mean difference|-9.98|STANDARD_ERROR_OF_MEAN|2.506|||TWO_SIDED|90.0|-14.19|-5.77||||||PF-04965842 200 mg vs Placebo: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-5.77|-14.19|
71144310|NCT02201524|141782125|SUPERIORITY_OR_OTHER||LS mean difference|-9.32|STANDARD_ERROR_OF_MEAN|8.291|||TWO_SIDED|90.0|-23.19|4.56||||||PF-04965842 200 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||4.56|-23.19|
71144311|NCT02201524|141782125|SUPERIORITY_OR_OTHER||LS mean difference|-11.19|STANDARD_ERROR_OF_MEAN|8.177|||TWO_SIDED|90.0|-24.87|2.5||||||PF-04965842 400 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||2.50|-24.87|
71144312|NCT02201524|141782125|SUPERIORITY_OR_OTHER||LS mean difference|-19.22|STANDARD_ERROR_OF_MEAN|8.504|||TWO_SIDED|90.0|-33.45|-4.99||||||PF-04965842 200 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-4.99|-33.45|
71144313|NCT02201524|141782125|SUPERIORITY_OR_OTHER||LS mean difference|-4.3|STANDARD_ERROR_OF_MEAN|10.387|||TWO_SIDED|90.0|-21.71|13.11||||||PF-04965842 200 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||13.11|-21.71|
71144314|NCT02201524|141782125|SUPERIORITY_OR_OTHER||LS mean difference|-18.04|STANDARD_ERROR_OF_MEAN|10.273|||TWO_SIDED|90.0|-35.25|-0.82||||||PF-04965842 400 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-0.82|-35.25|
71144315|NCT02201524|141782125|SUPERIORITY_OR_OTHER||LS mean difference|-27.07|STANDARD_ERROR_OF_MEAN|10.646|||TWO_SIDED|90.0|-44.9|-9.23||||||PF-04965842 200 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-9.23|-44.90|
70952379|NCT04546425|141406038|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|2.2|||||TWO_SIDED|95.0|0.7|4.1|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 15B||4.1|0.7|
70952380|NCT04546425|141406038|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F(13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|2.0|||||TWO_SIDED|95.0|0.4|3.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 22F||3.9|0.4|
70952381|NCT04546425|141406038|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|1.4|||||TWO_SIDED|95.0|-0.4|3.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 33F||3.4|-0.4|
70952382|NCT04546425|141406042|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-4.5|||||TWO_SIDED|95.0|-11.2|2.1|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|Diphtheria||2.1|-11.2|
70952383|NCT04546425|141406042|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-3.0|||||TWO_SIDED|95.0|-7.0|0.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|Tetanus||0.4|-7.0|
70952384|NCT04546425|141406042|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-0.5|||||TWO_SIDED|95.0|-5.2|4.1|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|PT||4.1|-5.2|
70952385|NCT04546425|141406042|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-1.5|||||TWO_SIDED|95.0|-6.4|3.3|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|FHA||3.3|-6.4|
70952386|NCT04546425|141406042|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-1.5|||||TWO_SIDED|95.0|-6.4|3.3|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|PRN||3.3|-6.4|
70952387|NCT04546425|141406042|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-3.3|||||TWO_SIDED|95.0|-10.0|2.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|Poliovirus Type 1||2.2|-10.0|
70952388|NCT04546425|141406042|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-2.8|||||TWO_SIDED|95.0|-11.8|5.8|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|Poliovirus Type 2||5.8|-11.8|
70952389|NCT04546425|141406042|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-4.2|||||TWO_SIDED|95.0|-10.2|-0.5|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|Poliovirus Type 3||-0.5|-10.2|
70952390|NCT04546425|141406042|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|0.0|||||TWO_SIDED|95.0|-1.8|2.0|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|Hib||2.0|-1.8|
70952391|NCT01399697|141406095|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||ANCOVA|||||||0.700
70952392|NCT01399697|141406096|SUPERIORITY_OR_OTHER|||||||0.328|TWO_SIDED||||||Chi-squared|||||||0.328
70952393|NCT01399697|141406097|SUPERIORITY_OR_OTHER|||||||0.518|TWO_SIDED||||||Chi-squared|||||||0.518
70952394|NCT01399697|141406098|SUPERIORITY_OR_OTHER|||||||0.358|TWO_SIDED||||||Chi-squared|||||||0.358
70952395|NCT01399697|141406099|SUPERIORITY_OR_OTHER||Difference in Least Square (LS) Mean|0.032||||0.674|TWO_SIDED|95.0|-0.119|0.184|||ANCOVA||Analysis of covariance (ANCOVA) model with treatment as factor and DAS28 value at Week 16 as covariate.|||0.184|-0.119|0.674
70952396|NCT01399697|141406100|SUPERIORITY_OR_OTHER||Difference in LS Mean|-1.873||||0.204|TWO_SIDED|95.0|-4.775|1.03|||ANCOVA||ANCOVA model with treatment as factor and mental component score (MCS) as covariate.|||1.030|-4.775|0.204
70952397|NCT01399697|141406101|SUPERIORITY_OR_OTHER||Difference in LS Mean|3.376||||0.015|TWO_SIDED|95.0|0.676|6.076|||ANCOVA||ANCOVA model with treatment as factor and physical component score (PCS) as covariate.|||6.076|0.676|0.015
70952398|NCT01399697|141406102|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.969||||0.769|TWO_SIDED|95.0|-5.526|7.464|||ANCOVA||ANCOVA model with treatment as factor and VAS performed by the participant at Week 16 as a covariate.|||7.464|-5.526|0.769
70952399|NCT01399697|141406103|SUPERIORITY_OR_OTHER||Difference in LS Mean|-1.216||||0.655|TWO_SIDED|95.0|-6.573|4.141|||ANCOVA||ANCOVA model with treatment as factor and VAS performed by the investigator at Week 16 as covariate.|||4.141|-6.573|0.655
70952400|NCT03617835|141406134|OTHER|Relative bioavailability|Ratio of the geometric means (T1/R) [%]|93.67|||||TWO_SIDED|90.0|78.48|111.8|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 26.0.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||111.80|78.48|
71144316|NCT02201524|141782125|SUPERIORITY_OR_OTHER||LS mean difference|-10.07|STANDARD_ERROR_OF_MEAN|11.013|||TWO_SIDED|90.0|-28.53|8.39||||||PF-04965842 200 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||8.39|-28.53|
70869699|NCT00042289|141224973|SUPERIORITY||Geometric mean ratio|0.9||||0.49|TWO_SIDED|90.0|0.71|1.16||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.16|0.71|0.49
70869700|NCT00042289|141224974|SUPERIORITY||Geometric mean ratio|0.45|||<|0.05|TWO_SIDED|90.0|0.32|0.63||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.63|0.32|<0.05
70869701|NCT00042289|141224974|SUPERIORITY||Geometric mean ratio|0.72|||<|0.05|TWO_SIDED|90.0|0.58|0.88||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.88|0.58|<0.05
70869702|NCT00042289|141224974|SUPERIORITY||Geometric mean ratio|0.42||||0.02|TWO_SIDED|90.0|0.23|0.78||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.78|0.23|0.02
70869703|NCT00042289|141224974|SUPERIORITY||Geometric mean ratio|0.78||||0.3|TWO_SIDED|90.0|0.56|1.08||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.08|0.56|0.3
70869704|NCT00042289|141224974|SUPERIORITY||Geometric mean ratio|1.41||||0.036|TWO_SIDED|||||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||||0.036
70869705|NCT00042289|141224974|SUPERIORITY||Geometric mean ratio|0.41|||<|0.05|TWO_SIDED|90.0|0.32|0.52||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.52|0.32|<0.05
70869706|NCT00042289|141224974|SUPERIORITY||Geometric mean ratio|0.48|||<|0.05|TWO_SIDED|90.0|0.41|0.57||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.57|0.41|<0.05
70869707|NCT00042289|141224975|SUPERIORITY||Geometric mean ratio|0.85||||0.1|TWO_SIDED|90.0|0.72|1.01||3rd Trimester vs. Postpartum|t-test, 2 sided|Paired sample t-test on natural log-transformed PK parameter||||1.01|0.72|0.10
70869708|NCT00042289|141224976|SUPERIORITY||Geometric mean ratio|0.49||||0.0039|TWO_SIDED|90.0|0.35|0.68||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.68|0.35|0.0039
70869709|NCT00042289|141224976|SUPERIORITY||Geometric mean ratio|0.66||||0.0062|TWO_SIDED|90.0|0.52|0.84||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.84|0.52|0.0062
70869710|NCT00042289|141224976|SUPERIORITY||||||<|0.1||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.10
70869711|NCT00042289|141224976|SUPERIORITY||||||<|0.1||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.10
70869712|NCT00042289|141224976|SUPERIORITY||Geometric mean ratio|0.15|||<|0.1|TWO_SIDED|90.0|0.08|0.3||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.30|0.08|<0.10
70869713|NCT00042289|141224976|SUPERIORITY||Geometric mean ratio|0.21|||<|0.1|TWO_SIDED|90.0|0.12|0.36||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.36|0.12|<0.10
70869714|NCT00042289|141224976|SUPERIORITY||Geometric mean ratio|0.32|||<|0.1|TWO_SIDED|90.0|0.2|0.51||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.51|0.20|<0.10
70869715|NCT00042289|141224976|SUPERIORITY||Geometric mean ratio|0.32|||>|0.1|TWO_SIDED|90.0|0.11|0.94||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.94|0.11|>0.10
70869716|NCT00042289|141224976|OTHER||Geometric mean ratio|0.87||||0.079|TWO_SIDED|90.0|0.78|0.97||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.97|0.78|0.079
70869717|NCT00042289|141224976|SUPERIORITY||Geometric mean ratio|0.92||||0.01|TWO_SIDED|90.0|0.77|1.09||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.09|0.77|0.01
70869718|NCT00042289|141224976|SUPERIORITY||Geometric mean ratio|0.51|||<|0.05|TWO_SIDED|90.0|0.37|0.72||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||0.72|0.37|<0.05
70869719|NCT00042289|141224976|SUPERIORITY||Geometric mean ratio|0.82||||0.0325|TWO_SIDED|90.0|0.71|0.96||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||0.96|0.71|0.0325
70869720|NCT00042289|141224976|SUPERIORITY||Geometric mean ratio|0.65|||<|0.05|TWO_SIDED|90.0|0.54|0.77||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||0.77|0.54|<0.05
70869721|NCT00042289|141224976|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
70869722|NCT00042289|141224976|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
70869723|NCT00042289|141224976|SUPERIORITY||||||>|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||>0.05
70869724|NCT00042289|141224976|SUPERIORITY||||||>|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||>0.05
70869725|NCT00042289|141224976|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
70869726|NCT00042289|141224976|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
70869727|NCT00042289|141224977|SUPERIORITY||Geometric mean ratio|0.88|||<|0.05|TWO_SIDED|90.0|0.73|1.06||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.06|0.73|<0.05
70869728|NCT00042289|141224977|SUPERIORITY||Geometric mean ratio|0.7|||<|0.05|TWO_SIDED|90.0|0.55|0.9||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.90|0.55|<0.05
70869729|NCT00042289|141224977|SUPERIORITY||Geometric mean ratio|0.84|||<|0.05|TWO_SIDED|90.0|0.57|1.23||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.23|0.57|<0.05
70869730|NCT00042289|141224981|SUPERIORITY||Geometric mean of ratio|1.24||||0.114|TWO_SIDED|90.0|0.97|1.59||Before ENG initiation vs. after ENG initiation|Wilcoxon signed rank test|||The statistical analysis is for LPV PK.||1.59|0.97|0.114
70869731|NCT00042289|141224982|SUPERIORITY||Geometric mean of ratio|1.1||||0.367|TWO_SIDED|90.0|0.84|1.44||Before ENG initiation vs. after ENG initiation|Wilcoxon signed rank test|||The statistical test is for ATV PK.||1.44|0.84|0.367
70869732|NCT00042289|141224982|SUPERIORITY||Geometric mean of ratio|1.02||||0.561|TWO_SIDED|90.0|0.92|1.13|||Wilcoxon signed rank test|Before ENG initiation vs. after ENG initiation||The statistical test is for EFV PK.||1.13|0.92|0.561
70869733|NCT00745823|141225007|NON_INFERIORITY_OR_EQUIVALENCE|The 800 mg q.d. dosage was considered non-inferior to 400 mg b.i.d. if the lower bound of the 2-sided exact 95% CI for difference in response rate remained above -10%.|Mean Difference (Final Values)|-5.7||||0.044|TWO_SIDED|95.0|-10.7|-0.83|||Miettinen and Nurminen|||||-0.83|-10.7|0.044
70869734|NCT00745823|141225008|NON_INFERIORITY_OR_EQUIVALENCE|The 800 mg q.d. dosage was considered non-inferior to 400 mg b.i.d. if the lower bound of the 2-sided exact 95% CI for difference in response rate remained above -10%.|Mean Difference (Final Values)|-5.1||||0.011|TWO_SIDED|95.0|-9.29|-1.06|||Miettinen and Nurminen|||||-1.06|-9.29|0.011
70869735|NCT00745823|141225009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-5.0|4.6|||Miettinen and Nurminen|||||4.6|-5.0|
70952401|NCT03617835|141406134|OTHER|Relative bioavailability|Ratio of the geometric means (T2/R) [%]|139.95|||||TWO_SIDED|90.0|117.26|167.03|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 26.0.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||167.03|117.26|
70952402|NCT03617835|141406135|OTHER|Relative bioavailability|Ratio of the geometric means (T3/R) [%]|121.84|||||TWO_SIDED|90.0|102.08|145.41|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 26.0.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||145.41|102.08|
70952403|NCT03617835|141406136|OTHER|Relative bioavailability|Ratio of the geometric means (T1/R) [%]|99.17|||||TWO_SIDED|90.0|83.77|117.39|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 24.8.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||117.39|83.77|
70952404|NCT03617835|141406136|OTHER|Relative bioavailability|Ratio of the geometric means (T2/R) [%]|156.2|||||TWO_SIDED|90.0|131.95|184.9|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 24.8.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||184.90|131.95|
70952405|NCT03617835|141406137|OTHER|Relative bioavailability|Ratio of the geometric means (T3/R) [%]|138.34|||||TWO_SIDED|90.0|116.87|163.77|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 24.8.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||163.77|116.87|
70952406|NCT03617835|141406138|OTHER|Relative bioavailability|Ratio of the geometric means (T1/R) [%]|93.58|||||TWO_SIDED|90.0|78.11|112.11|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 26.6.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||112.11|78.11|
71144317|NCT02201524|141782125|SUPERIORITY_OR_OTHER||LS mean difference|-29.23|STANDARD_ERROR_OF_MEAN|10.793|||TWO_SIDED|90.0|-47.33|-11.13||||||PF-04965842 400 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-11.13|-47.33|
71144318|NCT02201524|141782125|SUPERIORITY_OR_OTHER||LS mean difference|-49.99|STANDARD_ERROR_OF_MEAN|11.299|||TWO_SIDED|90.0|-68.92|-31.05||||||PF-04965842 200 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-31.05|-68.92|
71144319|NCT02201524|141782125|SUPERIORITY_OR_OTHER||LS mean difference|-24.25|STANDARD_ERROR_OF_MEAN|11.33|||TWO_SIDED|90.0|-43.26|-5.24||||||PF-04965842 200 mg vs Placebo at Week 4: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-5.24|-43.26|
71144320|NCT02201524|141782125|SUPERIORITY_OR_OTHER||LS mean difference|-27.47|STANDARD_ERROR_OF_MEAN|11.155|||TWO_SIDED|90.0|-46.18|-8.75||||||PF-04965842 400 mg vs Placebo at Week 4: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-8.75|-46.18|
71144321|NCT02201524|141782125|SUPERIORITY_OR_OTHER||LS mean difference|-52.63|STANDARD_ERROR_OF_MEAN|11.697|||TWO_SIDED|90.0|-72.24|-33.02||||||PF-04965842 200 mg vs Placebo at Week 4: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-33.02|-72.24|
71144322|NCT02201524|141782125|SUPERIORITY_OR_OTHER||LS mean difference|-17.98|STANDARD_ERROR_OF_MEAN|10.605|||TWO_SIDED|90.0|-35.8|-0.15|||LANCOVA|||PF-04965842 200 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-0.15|-35.80|
71144323|NCT02201524|141782125|SUPERIORITY_OR_OTHER||LS mean difference|-14.78|STANDARD_ERROR_OF_MEAN|10.513|||TWO_SIDED|90.0|-32.44|2.88||||||PF-04965842 400 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||2.88|-32.44|
71144324|NCT02201524|141782125|SUPERIORITY_OR_OTHER||LS mean difference|-47.94|STANDARD_ERROR_OF_MEAN|11.125|||TWO_SIDED|90.0|-66.61|-29.27||||||PF-04965842 200 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-29.27|-66.61|
71144325|NCT02201524|141782125|SUPERIORITY_OR_OTHER||LS mean|-21.75|STANDARD_ERROR_OF_MEAN|11.459|||TWO_SIDED|90.0|-41.0|-2.49||||||PF-04965842 200 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-2.49|-41.00|
71144326|NCT02201524|141782125|SUPERIORITY_OR_OTHER||LS mean difference|-17.75|STANDARD_ERROR_OF_MEAN|11.416|||TWO_SIDED|90.0|-36.92|1.42||||||PF-04965842 400 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||1.42|-36.92|
71144327|NCT02201524|141782125|SUPERIORITY_OR_OTHER||LS mean difference|-35.88|STANDARD_ERROR_OF_MEAN|11.893|||TWO_SIDED|90.0|-55.85|-15.9||||||PF-04965842 200 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-15.90|-55.85|
71144328|NCT02201524|141782125|SUPERIORITY_OR_OTHER||LS mean difference|-10.75|STANDARD_ERROR_OF_MEAN|12.985|||TWO_SIDED|90.0|-32.57|11.07||||||PF-04965842 200 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||11.07|-32.57|
71144329|NCT02201524|141782125|SUPERIORITY_OR_OTHER||LS mean difference|-13.03|STANDARD_ERROR_OF_MEAN|12.902|||TWO_SIDED|90.0|-34.71|8.64||||||PF-04965842 400 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||8.64|-34.71|
71144330|NCT02201524|141782125|SUPERIORITY_OR_OTHER||LS mean difference|-34.46|STANDARD_ERROR_OF_MEAN|13.69|||TWO_SIDED|90.0|-57.44|-11.48||||||PF-04965842 200 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-11.48|-57.44|
71144331|NCT02201524|141782126|SUPERIORITY_OR_OTHER||LS mean difference|-2.01|STANDARD_ERROR_OF_MEAN|1.626|||TWO_SIDED|90.0|-4.73|0.72||||||PF-04965842 200 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||0.72|-4.73|
71144332|NCT02201524|141782126|SUPERIORITY_OR_OTHER||LS mean difference|-2.31|STANDARD_ERROR_OF_MEAN|1.603|||TWO_SIDED|90.0|-4.99|0.38||||||PF-04965842 400 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||0.38|-4.99|
71144333|NCT02201524|141782126|SUPERIORITY_OR_OTHER||LS mean difference|-3.65|STANDARD_ERROR_OF_MEAN|1.668|||TWO_SIDED|90.0|-6.45|-0.86||||||PF-04965842 200 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-0.86|-6.45|
71144334|NCT02201524|141782126|SUPERIORITY_OR_OTHER||LS mean difference|-1.08|STANDARD_ERROR_OF_MEAN|2.032|||TWO_SIDED|90.0|-4.49|2.32||||||PF-04965842 200 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||2.32|-4.49|
71144335|NCT02201524|141782126|SUPERIORITY_OR_OTHER||LS mean difference|-3.86|STANDARD_ERROR_OF_MEAN|2.011|||TWO_SIDED|90.0|-7.23|-0.49||||||PF-04965842 400 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-0.49|-7.23|
71144336|NCT02201524|141782126|SUPERIORITY_OR_OTHER||LS mean difference|-5.16|STANDARD_ERROR_OF_MEAN|2.084|||TWO_SIDED|90.0|-8.65|-1.67||||||PF-04965842 200 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-1.67|-8.65|
71144337|NCT02201524|141782126|SUPERIORITY_OR_OTHER||LS mean difference|-2.34|STANDARD_ERROR_OF_MEAN|2.224|||TWO_SIDED|90.0|-6.07|1.39||||||PF-04965842 200 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||1.39|-6.07|
71144338|NCT02201524|141782126|SUPERIORITY_OR_OTHER||LS mean difference|-6.12|STANDARD_ERROR_OF_MEAN|2.177|||TWO_SIDED|90.0|-9.78|-2.47||||||PF-04965842 400 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-2.47|-9.78|
70869736|NCT00745823|141225010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-1.3|2.0||||||||2.0|-1.3|
70869737|NCT00745823|141225011|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.56|||||TWO_SIDED|95.0|-7.29|34.4|||t-test, 2 sided|||||34.40|-7.29|
71144339|NCT02201524|141782126|SUPERIORITY_OR_OTHER||LS mean difference|-9.39|STANDARD_ERROR_OF_MEAN|2.286|||TWO_SIDED|90.0|-13.22|-5.56||||||PF-04965842 200 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-5.56|-13.22|
71144340|NCT02201524|141782126|SUPERIORITY_OR_OTHER||LS mean difference|-3.25|STANDARD_ERROR_OF_MEAN|2.054|||TWO_SIDED|90.0|-6.71|0.21||||||PF-04965842 200 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||0.21|-6.71|
71144341|NCT02201524|141782126|SUPERIORITY_OR_OTHER||LS mean difference|-2.98|STANDARD_ERROR_OF_MEAN|2.035|||TWO_SIDED|90.0|-6.4|0.45||||||PF-04965842 400 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||0.45|-6.40|
71144342|NCT02201524|141782126|SUPERIORITY_OR_OTHER||LS mean difference|-8.59|STANDARD_ERROR_OF_MEAN|2.167|||TWO_SIDED|90.0|-12.24|-4.95||||||PF-04965842 200 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-4.95|-12.24|
71144343|NCT02201524|141782126|SUPERIORITY_OR_OTHER||LS mean difference|-3.98|STANDARD_ERROR_OF_MEAN|2.321|||TWO_SIDED|90.0|-7.89|-0.08||||||PF-04965842 200 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-0.08|-7.89|
71144344|NCT02201524|141782126|SUPERIORITY_OR_OTHER||LS mean difference|-3.8|STANDARD_ERROR_OF_MEAN|2.304|||TWO_SIDED|90.0|-7.68|0.07||||||PF-04965842 400 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||0.07|-7.68|
71144345|NCT02201524|141782126|SUPERIORITY_OR_OTHER||LS mean difference|-6.94|STANDARD_ERROR_OF_MEAN|2.412|||TWO_SIDED|90.0|-11.0|-2.89||||||PF-04965842 200 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-2.89|-11.00|
71144346|NCT02201524|141782126|SUPERIORITY_OR_OTHER||LS mean difference|-1.27|STANDARD_ERROR_OF_MEAN|2.607|||TWO_SIDED|90.0|-5.65|3.11||||||PF-04965842 200 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||3.11|-5.65|
71144347|NCT02201524|141782126|SUPERIORITY_OR_OTHER||LS mean difference|-2.83|STANDARD_ERROR_OF_MEAN|2.586|||TWO_SIDED|90.0|-7.18|1.51||||||PF-04965842 400 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||1.51|-7.18|
71144348|NCT02201524|141782126|SUPERIORITY_OR_OTHER||LS mean difference|-6.52|STANDARD_ERROR_OF_MEAN|2.758|||TWO_SIDED|90.0|-11.15|-1.89||||||PF-04965842 200 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-1.89|-11.15|
71144349|NCT02201524|141782127|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.5|||||TWO_SIDED|90.0|-21.5|19.6||||||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||19.6|-21.5|
71144350|NCT02201524|141782127|SUPERIORITY_OR_OTHER||Difference in Percentage|17.9|||||TWO_SIDED|90.0|-5.9|40.3||||||PF-04965842 400 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||40.3|-5.9|
71144351|NCT02201524|141782127|SUPERIORITY_OR_OTHER||Difference in Percentage|14.3|||||TWO_SIDED|90.0|-9.3|38.0|||Difference in Percentage Analysed using|||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||38.0|-9.3|
71144352|NCT02201524|141782127|SUPERIORITY_OR_OTHER||Difference in Percentage|-14.3|||||TWO_SIDED|90.0|-38.0|9.3||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||9.3|-38.0|
71144353|NCT02201524|141782127|SUPERIORITY_OR_OTHER||Difference in Percentage|1.6|||||TWO_SIDED|90.0|-25.4|29.1||||||PF-04965842 400 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||29.1|-25.4|
71144354|NCT02201524|141782127|SUPERIORITY_OR_OTHER||Difference in Percentage|20.2|||||TWO_SIDED|90.0|-10.2|48.3||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||48.3|-10.2|
71144355|NCT02201524|141782127|SUPERIORITY_OR_OTHER||Difference in Percentage|1.9|||||TWO_SIDED|90.0|-26.7|31.0||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||31.0|-26.7|
71144356|NCT02201524|141782127|SUPERIORITY_OR_OTHER||Difference in Percentage|23.6|||||TWO_SIDED|90.0|-6.9|49.8||||||PF-04965842 400 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||49.8|-6.9|
71144357|NCT02201524|141782127|SUPERIORITY_OR_OTHER||Difference in Percentage|67.8|||||TWO_SIDED|90.0|36.4|85.3||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||85.3|36.4|
71144358|NCT02201524|141782127|SUPERIORITY_OR_OTHER||Difference in Percentage|41.7|||||TWO_SIDED|90.0|7.6|67.1||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||67.1|7.6|
71144359|NCT02201524|141782127|SUPERIORITY_OR_OTHER||Difference in Percentage|41.7|||||TWO_SIDED|90.0|7.6|67.1||||||PF-04965842 400 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||67.1|7.6|
71144360|NCT02201524|141782127|SUPERIORITY_OR_OTHER||Difference in Percentage|55.0|||||TWO_SIDED|90.0|19.7|77.6||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||77.6|19.7|
71144361|NCT02201524|141782127|SUPERIORITY_OR_OTHER||Difference in Percentage|12.1|||||TWO_SIDED|90.0|-21.4|43.4||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||43.4|-21.4|
71144362|NCT02201524|141782127|SUPERIORITY_OR_OTHER||Difference in Percentage|3.8|||||TWO_SIDED|90.0|-29.4|36.4||||||PF-04965842 400 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||36.4|-29.4|
71144363|NCT02201524|141782127|SUPERIORITY_OR_OTHER||Difference in Percentage|45.5|||||TWO_SIDED|90.0|17.1|69.0||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||69.0|17.1|
71144364|NCT02201524|141782127|SUPERIORITY_OR_OTHER||Difference in Percentage|36.4|||||TWO_SIDED|90.0|1.9|63.4||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||63.4|1.9|
71144365|NCT02201524|141782127|SUPERIORITY_OR_OTHER||Difference in Percentage|14.5|||||TWO_SIDED|90.0|-21.4|47.0||||||PF-04965842 400 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||47.0|-21.4|
70869738|NCT01687998|141225017|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.006||||0.9054|TWO_SIDED|95.0|0.911|1.111|||Regression, Cox|||Primary Endpoint: Time to First Occurrence of the Composite Primary Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Coronary Revascularization, or Hospitalization for Unstable Angina (UA)||1.111|0.911|0.9054
71144366|NCT02201524|141782127|SUPERIORITY_OR_OTHER||Difference in Percentage|24.5|||||TWO_SIDED|90.0|-11.8|54.9||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||54.9|-11.8|
70869739|NCT01687998|141225018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-37.11|||<|0.0001|TWO_SIDED|95.0|-38.15|-36.08|||ANOVA|||LDL-C||-36.08|-38.15|<0.0001
70869740|NCT01687998|141225018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|131.55|||<|0.0001|TWO_SIDED|95.0|130.01|133.09|||ANOVA|||HDL-C||133.09|130.01|<0.0001
71144367|NCT02201524|141782127|SUPERIORITY_OR_OTHER||Difference in Percentage|-4.5|||||TWO_SIDED|90.0|-40.4|32.3||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||32.3|-40.4|
71144368|NCT02201524|141782127|SUPERIORITY_OR_OTHER||Difference in Percentage|13.6|||||TWO_SIDED|90.0|-23.7|48.2||||||PF-04965842 400 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||48.2|-23.7|
71144369|NCT02201524|141782127|SUPERIORITY_OR_OTHER||Difference in Percentage|12.5|||||TWO_SIDED|90.0|-28.0|49.3||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||49.3|-28.0|
71144370|NCT02201524|141782128|SUPERIORITY_OR_OTHER||Difference in Percentage|7.1|||||TWO_SIDED|90.0|-10.2|27.0||||||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||27.0|-10.2|
71144371|NCT02201524|141782128|SUPERIORITY_OR_OTHER||Difference in Percentage|-7.1|||||TWO_SIDED|90.0|-27.0|10.2||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||10.2|-27.0|
71144372|NCT02201524|141782128|SUPERIORITY_OR_OTHER||Difference in Percentage|8.2|||||TWO_SIDED|90.0|-14.4|32.2||||||PF-04965842 400 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||32.2|-14.4|
71144373|NCT02201524|141782128|SUPERIORITY_OR_OTHER||Difference in Percentage|17.9|||||TWO_SIDED|90.0|-6.7|43.6||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||43.6|-6.7|
71144374|NCT02201524|141782128|SUPERIORITY_OR_OTHER||Difference in Percentage|-7.7|||||TWO_SIDED|90.0|-28.8|12.1||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||12.1|-28.8|
71144375|NCT02201524|141782128|SUPERIORITY_OR_OTHER||Difference in Percentage|32.3|||||TWO_SIDED|90.0|5.4|55.4||||||PF-04965842 400 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||55.4|5.4|
71144376|NCT02201524|141782128|SUPERIORITY_OR_OTHER||Difference in Percentage|28.7|||||TWO_SIDED|90.0|0.8|55.3||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||55.3|0.8|
71144377|NCT02201524|141782128|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|90.0|-27.3|27.3||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||27.3|-27.3|
71144378|NCT02201524|141782128|SUPERIORITY_OR_OTHER||Difference in Percentage|33.3|||||TWO_SIDED|90.0|1.0|59.8||||||PF-04965842 400 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||59.8|1.0|
71144379|NCT02201524|141782128|SUPERIORITY_OR_OTHER||Difference in Percentage|43.3|||||TWO_SIDED|90.0|8.8|69.3||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||69.3|8.8|
71144380|NCT02201524|141782128|SUPERIORITY_OR_OTHER||Difference in Percentage|25.0|||||TWO_SIDED|90.0|2.1|49.3||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||49.3|2.1|
71144381|NCT02201524|141782128|SUPERIORITY_OR_OTHER||Difference in Percentage|50.0|||||TWO_SIDED|90.0|25.4|71.8||||||PF-04965842 400 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||71.8|25.4|
71144382|NCT02201524|141782128|SUPERIORITY_OR_OTHER||Difference in Percentage|66.7|||||TWO_SIDED|90.0|39.2|86.1||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||86.1|39.2|
71144383|NCT02201524|141782128|SUPERIORITY_OR_OTHER||Difference in Percentage|-9.1|||||TWO_SIDED|90.0|-36.3|18.3||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||18.3|-36.3|
71144384|NCT02201524|141782128|SUPERIORITY_OR_OTHER||Difference in Percentage|41.8|||||TWO_SIDED|90.0|6.2|68.5||||||PF-04965842 400 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||68.5|6.2|
71144385|NCT02201524|141782128|SUPERIORITY_OR_OTHER||Difference in Percentage|31.8|||||TWO_SIDED|90.0|-2.9|60.5||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||60.5|-2.9|
71144386|NCT02201524|141782128|SUPERIORITY_OR_OTHER||Difference in Percentage|-15.9|||||TWO_SIDED|90.0|-47.8|13.7||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||13.7|-47.8|
71144387|NCT02201524|141782128|SUPERIORITY_OR_OTHER||Difference in Percentage|-6.8|||||TWO_SIDED|90.0|-40.6|24.8||||||PF-04965842 400 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||24.8|-40.6|
71144388|NCT02201524|141782128|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|90.0|-36.4|36.4||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||36.4|-36.4|
71144389|NCT02201524|141782129|SUPERIORITY_OR_OTHER||Difference in Percentage|7.1|||||TWO_SIDED|90.0|-10.2|27.0||||||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||27.0|-10.2|
71144390|NCT02201524|141782129|SUPERIORITY_OR_OTHER||Difference in Percentage|-7.1|||||TWO_SIDED|90.0|-27.0|10.2||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||10.2|-27.0|
71144391|NCT02201524|141782129|SUPERIORITY_OR_OTHER||Difference in Percentage|0.5|||||TWO_SIDED|90.0|-20.7|22.8||||||PF-04965842 400 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||22.8|-20.7|
71144392|NCT02201524|141782129|SUPERIORITY_OR_OTHER||Difference in Percentage|1.2|||||TWO_SIDED|90.0|-20.3|24.8||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||24.8|-20.3|
71144393|NCT02201524|141782129|SUPERIORITY_OR_OTHER||Difference in Percentage|13.3|||||TWO_SIDED|90.0|-5.6|33.8||||||PF-04965842 400 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||33.8|-5.6|
71144394|NCT02201524|141782129|SUPERIORITY_OR_OTHER||Difference in Percentage|36.4|||||TWO_SIDED|90.0|15.3|61.1||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||61.1|15.3|
71144395|NCT02201524|141782129|SUPERIORITY_OR_OTHER||Difference in Percentage|33.3|||||TWO_SIDED|90.0|11.3|57.3||||||PF-04965842 400 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||57.3|11.3|
70869741|NCT01687998|141225019|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.991||||0.8463|TWO_SIDED|95.0|0.901|1.089|||Regression, Cox|||Time to First Occurrence of the Composite Endpoint of All-Cause Mortality, MI, Stroke, Coronary Revascularization, or Hospitalization for UA||1.089|0.901|0.8463
70869742|NCT01687998|141225020|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.001||||0.9874|TWO_SIDED|95.0|0.901|1.112|||Regression, Cox|||Time to First Occurrence of the Composite Endpoint of CV Death, MI, or Coronary Revascularization||1.112|0.901|0.9874
71144396|NCT02201524|141782129|SUPERIORITY_OR_OTHER||Difference in Percentage|60.0|||||TWO_SIDED|90.0|34.7|80.9||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||80.9|34.7|
70869743|NCT01687998|141225021|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.003||||0.9574|TWO_SIDED|95.0|0.893|1.127|||Regression, Cox|||Time to First Occurrence of the Composite Endpoint of CV Death, MI, Stroke, or Hospitalization for UA||1.127|0.893|0.9574
70869744|NCT01687998|141225022|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.965||||0.5917|TWO_SIDED|95.0|0.846|1.1|||Regression, Cox|||Time to First Occurrence of Triple Composite Endpoint of CV Death, MI, or Stroke||1.100|0.846|0.5917
71144397|NCT02201524|141782129|SUPERIORITY_OR_OTHER||Difference in Percentage|25.0|||||TWO_SIDED|90.0|2.1|49.3||||||PF-04965842 400 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||49.3|2.1|
71144398|NCT02201524|141782129|SUPERIORITY_OR_OTHER||Difference in Percentage|44.4|||||TWO_SIDED|90.0|19.4|70.2||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||70.2|19.4|
71144399|NCT02201524|141782129|SUPERIORITY_OR_OTHER||Difference in Percentage|20.0|||||TWO_SIDED|90.0|-2.7|46.6||||||PF-04965842 400 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||46.6|-2.7|
71144400|NCT02201524|141782129|SUPERIORITY_OR_OTHER||Difference in Percentage|30.0|||||TWO_SIDED|90.0|6.4|56.4||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||56.4|6.4|
71144401|NCT02201524|141782129|SUPERIORITY_OR_OTHER||Difference in Percentage|25.0|||||TWO_SIDED|90.0|-4.9|54.9||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||54.9|-4.9|
71144402|NCT02201524|141782130|SUPERIORITY_OR_OTHER||Difference in Percentage|13.3|||||TWO_SIDED|90.0|-4.4|33.8||||||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||33.8|-4.4|
71144403|NCT02201524|141782130|SUPERIORITY_OR_OTHER||Difference in Percentage|12.5|||||TWO_SIDED|90.0|-5.2|32.0||||||PF-04965842 400 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||32.0|-5.2|
71144404|NCT02201524|141782130|SUPERIORITY_OR_OTHER||Difference in Percentage|7.1|||||TWO_SIDED|90.0|-10.2|27.0||||||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||27.0|-10.2|
71144405|NCT02201524|141782130|SUPERIORITY_OR_OTHER||Difference in Percentage|21.4|||||TWO_SIDED|90.0|-3.2|45.5||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||45.5|-3.2|
71144406|NCT02201524|141782130|SUPERIORITY_OR_OTHER||Difference in Percentage|15.9|||||TWO_SIDED|90.0|-8.1|40.7||||||PF-04965842 400 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||40.7|-8.1|
71144407|NCT02201524|141782130|SUPERIORITY_OR_OTHER||Difference in Percentage|34.5|||||TWO_SIDED|90.0|7.3|59.4||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||59.4|7.3|
71144408|NCT02201524|141782130|SUPERIORITY_OR_OTHER||Difference in Percentage|17.9|||||TWO_SIDED|90.0|-11.2|45.5||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||45.5|-11.2|
71144409|NCT02201524|141782130|SUPERIORITY_OR_OTHER||Difference in Percentage|31.3|||||TWO_SIDED|90.0|1.7|55.7||||||PF-04965842 400 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||55.7|1.7|
71144410|NCT02201524|141782130|SUPERIORITY_OR_OTHER||Difference in Percentage|30.1|||||TWO_SIDED|90.0|-1.2|57.4|||Difference in Percentage Analysed using|||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||57.4|-1.2|
71144411|NCT02201524|141782130|SUPERIORITY_OR_OTHER||Difference in Percentage|25.0|||||TWO_SIDED|90.0|-6.4|52.5||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||52.5|-6.4|
71144412|NCT02201524|141782130|SUPERIORITY_OR_OTHER||Difference in Percentage|41.7|||||TWO_SIDED|90.0|8.7|66.7||||||PF-04965842 400 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||66.7|8.7|
71144413|NCT02201524|141782130|SUPERIORITY_OR_OTHER||Difference in Percentage|53.3|||||TWO_SIDED|90.0|18.5|76.6||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||76.6|18.5|
71144414|NCT02201524|141782130|SUPERIORITY_OR_OTHER||Difference in Percentage|6.1|||||TWO_SIDED|90.0|-26.1|36.6||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||36.6|-26.1|
71144415|NCT02201524|141782130|SUPERIORITY_OR_OTHER||Difference in Percentage|14.4|||||TWO_SIDED|90.0|-18.9|44.5||||||PF-04965842 400 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||44.5|-18.9|
71144416|NCT02201524|141782130|SUPERIORITY_OR_OTHER||Difference in Percentage|50.5|||||TWO_SIDED|90.0|12.9|75.3||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||75.3|12.9|
71144417|NCT02201524|141782130|SUPERIORITY_OR_OTHER||Difference in Percentage|9.1|||||TWO_SIDED|90.0|-25.2|41.4||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||41.4|-25.2|
71144418|NCT02201524|141782130|SUPERIORITY_OR_OTHER||Difference in Percentage|3.6|||||TWO_SIDED|90.0|-30.5|37.3||||||PF-04965842 400 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||37.3|-30.5|
71144419|NCT02201524|141782130|SUPERIORITY_OR_OTHER||Difference in Percentage|13.6|||||TWO_SIDED|90.0|-21.9|46.2||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||46.2|-21.9|
71144420|NCT02201524|141782130|SUPERIORITY_OR_OTHER||Difference in Percentage|2.3|||||TWO_SIDED|90.0|-33.2|34.6||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||34.6|-33.2|
71144421|NCT02201524|141782130|SUPERIORITY_OR_OTHER||Difference in Percentage|20.5|||||TWO_SIDED|90.0|-17.6|51.9||||||PF-04965842 400 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||51.9|-17.6|
70869745|NCT01135420|141225031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||<|0.05|TWO_SIDED||||||ANCOVA|||||||<.05
70869746|NCT00717197|141225032|SUPERIORITY_OR_OTHER||Percentage|21.7|STANDARD_ERROR_OF_MEAN|7.27|||TWO_SIDED|95.0|7.46|43.7||||||||43.7|7.46|
70869747|NCT02955602|141225063|OTHER||||||=|0.2242|||||||ANCOVA|||The analyses will assess the change from baseline in each treatment group and will assess the hypothesis that there are no differences in the percent change in ALP serum level between seladelpar 2 mg and 5 mg treatment groups after 8 weeks of treatment.||||= 0.2242
70952407|NCT03617835|141406138|OTHER|Relative bioavailability|Ratio of the geometric means (T2/R) [%]|139.73|||||TWO_SIDED|90.0|116.64|167.4|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 26.6.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||167.40|116.64|
70952408|NCT03617835|141406139|OTHER|Relative bioavailability|Ratio of the geometric means (T3/R) [%]|121.34|||||TWO_SIDED|90.0|101.28|145.37|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 26.6.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||145.37|101.28|
70952409|NCT02833077|141406166|SUPERIORITY||Responder Rate Difference|28.85||||0.0019|TWO_SIDED|95.0|11.16|45.6||If the 2-sided p-value is \< 0.05, the responder rate is greater for treatment than for control group, and point estimate of the responder rater for treatment group is greater than 50%, then treatment will be considered superior to control group.|Fisher's exact test|||Superiority of treatment group was established if responder rate at month 6 was statistically greater than that for the control group at month 6 and the observed responder rate at month 6 for the treatment group was greater than 50%.||45.60|11.16|0.0019
70952410|NCT02833077|141406167|OTHER||||||<|0.0001||||||P-value is based on a 2-sided paired t-test at the 5% level to demonstrate that the mean overall satisfaction score at month 6 visit is statistically greater than that at the baseline for the treatment group.|Two sided paired t-test|||||||<.0001
70952411|NCT00972322|141406170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.34|STANDARD_ERROR_OF_MEAN|8.7||0.083|TWO_SIDED|90.0|-29.87|-0.82|||Least Squares Means Difference||Placebo - MK-8245 on Day 28|||-0.82|-29.87|0.083
70952412|NCT01077518|141406173|SUPERIORITY||Stratified Cox propor.hazards regression|0.82||||0.139|TWO_SIDED|95.0|0.62|1.07|||Stratified Log-Rank|||||1.07|0.62|0.1390
70952413|NCT01077518|141406174|OTHER||Stratified Cox propor.hazards regression|0.76||||0.1076|TWO_SIDED|95.0|0.55|1.06|||Stratified Log-Rank|||||1.06|0.55|0.1076
70952414|NCT01077518|141406175|OTHER|||||||0.8003|||||||Cochran-Mantel-Haenszel|adjusted for stratum||for All participants||||0.8003
70952415|NCT01077518|141406176|OTHER|||||||0.613|||||||Cochran-Mantel-Haenszel|adjusted for stratum||for Follicular Lymphoma (FL) participants||||0.6130
70869748|NCT02955602|141225063|OTHER||||||=|0.0021|||||||ANCOVA|||The analyses will assess the change from baseline in each treatment group and will assess the hypothesis that there are no differences in the percent change in ALP serum level between seladelpar 2 mg and 10 mg treatment groups after 8 weeks of treatment||||= 0.0021
70869749|NCT02955602|141225063|OTHER||||||=|0.0024|||||||ANCOVA|||The analyses will assess the change from baseline in each treatment group and will assess the hypothesis that there are no differences in the percent change in ALP serum level between seladelpar 5 mg and 10 mg treatment groups after 8 weeks of treatment||||= 0.0024
70952416|NCT01077518|141406177|OTHER||Hazard Ratio (HR)|0.87||||0.4046|TWO_SIDED|95.0|0.62|1.21|||Stratified Log Rank|||for All patients||1.21|0.62|0.4046
70952417|NCT01077518|141406178|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.3768|TWO_SIDED|95.0|0.55|1.25|||Stratified Log Rank|||for FL participants||1.25|0.55|0.3768
70952418|NCT01495598|141406202|OTHER|Other = Kaplan Meier||||||0.43|||||||Log Rank|||||||0.43
70952419|NCT01495598|141406212|OTHER|\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.19||||||The reported p-value is representative of the changes in levels of IFNƴ among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.19
70952420|NCT01495598|141406212|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.72||||||The reported p-value is representative of the changes in levels of IFNƴ among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.72
70952421|NCT01495598|141406212|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.03||||||The reported p-value is representative of the changes in levels of IFNƴ among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.03
70952422|NCT01495598|141406212|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.|||||<|0.0001||||||The reported p-value is representative of the changes in levels of IL4 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||<0.0001
70869750|NCT01258582|141225082|SUPERIORITY_OR_OTHER||difference in the acceptance rates|-0.022||||0.34|TWO_SIDED|95.0|-0.067|0.023|||Chi-squared|The difference in the acceptance rates was estimated along with 95% confidence intervals and tested using the chi-square test.||Sample size was chosen to detect a 10% difference in acceptance rates between two testing modality arms (90% power, 0.05 level of significance).||0.023|-0.067|0.34
70952423|NCT01495598|141406212|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.|||||<|0.0001||||||The reported p-value is representative of the changes in levels of IL4 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||<0.0001
70869751|NCT03156543|141225154|SUPERIORITY|||||||0.004|||||||Fisher Exact|||Analysis was based on the participants who were positive for C. acnes.||||0.004
70869752|NCT00674700|141225156|SUPERIORITY_OR_OTHER|||||||0.0066||||||main effects = treatment and pools of study centers, Covariates = age, gender, asthma status, sensitization status and baseline ARTSS|ANCOVA|||||||0.0066
70952424|NCT01495598|141406212|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.|||||<|0.0001||||||The reported p-value is representative of the changes in levels of IL4 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||<0.0001
70952425|NCT01495598|141406212|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.005||||||The reported p-value is representative of the changes in levels of IL6 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.005
70869753|NCT00674700|141225156|SUPERIORITY_OR_OTHER|||||||0.015||||||main effects= treatment and pools of study centers, Covariates = age, gender, asthma status, sensitization status and baseline ARTSS|ANCOVA|||||||0.015
70869754|NCT00674700|141225157|SUPERIORITY_OR_OTHER|||||||0.0086|||||||ANCOVA|||||||0.0086
70869755|NCT00674700|141225157|SUPERIORITY_OR_OTHER|||||||0.0095|||||||ANCOVA|||||||0.0095
70869756|NCT01509950|141225193|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.60
70869757|NCT04115839|141225214|SUPERIORITY||Difference in response rates|26.9||||0.022|TWO_SIDED|95.0|4.3|49.6||The stratification factors (Geographic Region, Concurrent Use of conventional synthetic (cs) DMARD(s) and/or Apremilast at Randomization, Prior Use of biologic (bio)DMARD(s)) and treatment groups were included in the imputation model as covariates.|Multiple imputation method|||||49.6|4.3|0.022
70869758|NCT04115839|141225214|SUPERIORITY||Difference in response rates|2.2||||0.89|TWO_SIDED|95.0|-20.5|25.0||The stratification factors (Geographic Region, Concurrent Use of csDMARD(s) and/or Apremilast at Randomization, Prior Use of bioDMARD(s)) and treatment groups were included in the imputation model as covariates.|Multiple imputation method|||||25.0|-20.5|0.89
70869759|NCT04115839|141225217|SUPERIORITY||Difference in response rates|-5.9||||0.39|TWO_SIDED|95.0|-21.6|9.9||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||9.9|-21.6|0.39
70869760|NCT04115839|141225217|SUPERIORITY||Difference in response rates|-2.6||||0.65|TWO_SIDED|95.0|-19.7|14.5||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||14.5|-19.7|0.65
70869761|NCT04115839|141225217|SUPERIORITY||Difference in response rates|0.9||||0.86|TWO_SIDED|-19.4|-19.4|21.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||21.3|-19.4|0.86
70869762|NCT04115839|141225217|SUPERIORITY||Difference in response rates|-2.9||||0.7|TWO_SIDED|95.0|-22.0|16.1||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||16.1|-22.0|0.70
70952426|NCT01495598|141406212|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.06||||||The reported p-value is representative of the changes in levels of IL6 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.06
70952427|NCT01495598|141406212|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.007||||||The reported p-value is representative of the changes in levels of IL6 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.007
70952428|NCT01495598|141406212|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.0003||||||The reported p-value is representative of the changes in levels of IL8 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.0003
70952429|NCT01495598|141406212|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.0002||||||The reported p-value is representative of the changes in levels of IL8 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.0002
70952430|NCT01495598|141406212|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.01||||||The reported p-value is representative of the changes in levels of IL8 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.01
70952431|NCT01495598|141406212|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.03||||||The reported p-value is representative of the changes in levels of IL6 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.03
70952432|NCT01495598|141406212|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.91||||||The reported p-value is representative of the changes in levels of IL10 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.91
70869763|NCT04115839|141225217|SUPERIORITY||Difference in response rates|12.4||||0.15|TWO_SIDED|95.0|-7.5|32.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||32.3|-7.5|0.15
70869764|NCT04115839|141225217|SUPERIORITY||Difference in response rates|8.8||||0.3|TWO_SIDED|95.0|-10.1|27.7||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||27.7|-10.1|0.30
70952433|NCT01495598|141406212|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.64||||||The reported p-value is representative of the changes in levels of IL10 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.64
70952434|NCT01495598|141406212|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.7||||||The reported p-value is representative of the changes in levels of IL12 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.70
70952435|NCT01495598|141406212|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.59||||||The reported p-value is representative of the changes in levels of IL12 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.59
70952436|NCT01495598|141406212|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.26||||||The reported p-value is representative of the changes in levels of IL12 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.26
70952437|NCT01495598|141406212|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.0008||||||The reported p-value is representative of the changes in levels of IL13 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.0008
70952438|NCT01495598|141406212|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.|||||<|0.0001||||||The reported p-value is representative of the changes in levels of IL13 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||<0.0001
70952439|NCT01495598|141406212|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.007||||||The reported p-value is representative of the changes in levels of IL13 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.007
70952440|NCT01495598|141406212|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.005||||||The reported p-value is representative of the changes in levels of TNFα among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.005
70952441|NCT01495598|141406212|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.007||||||The reported p-value is representative of the changes in levels of TNFα among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.007
71144422|NCT02201524|141782130|SUPERIORITY_OR_OTHER||Difference in Percentage|12.5|||||TWO_SIDED|90.0|-26.4|48.1||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||48.1|-26.4|
71144423|NCT01018030|141782170|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.386||||0.008|TWO_SIDED|95.0|-0.67|-0.1|||ANCOVA||The estimation for least squares mean was adjusted for baseline value, country, allergic rhinitis status, age, and gender.|||-0.10|-0.67|0.008
70952442|NCT01495598|141406212|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.007||||||The reported p-value is representative of the changes in levels of TNFα among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.007
70952443|NCT01495598|141406212|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.42||||||The reported p-value is representative of the changes in levels of IP-10 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.42
70952444|NCT01495598|141406212|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.85||||||The reported p-value is representative of the changes in levels of IP-10 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.85
70952445|NCT01495598|141406212|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.16||||||The reported p-value is representative of the changes in levels of IP-10 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.16
70952446|NCT01495598|141406213|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.07||||||The reported p-value is representative of the changes in levels of CD4+ cells/µL among all participants.|Wilcoxon signed rank test|||||||0.07
70952447|NCT01495598|141406213|NON_INFERIORITY|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.13||||||The reported p-value is representative of the changes in levels of CD4+cells/µL among all participants.|Wilcoxon signed rank test|||||||0.13
70952448|NCT01495598|141406213|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.15||||||The reported p-value is representative of the changes in levels of CD4+cells/µL among all participants.|Wilcoxon signed rank test|||||||0.15
70952449|NCT01495598|141406213|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.03||||||The reported p-value is representative of the changes in levels of CD4+cells/µL among HIV+ participants.|Wilcoxon signed rank test|||||||0.03
70952450|NCT01495598|141406213|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.06||||||The reported p-value is representative of the changes in levels of CD4+cells/µL among HIV+ participants.|Wilcoxon signed rank test|||||||0.06
70952451|NCT01495598|141406213|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.79||||||The reported p-value is representative of the changes in levels of CD4+cells/µL among HIV+ participants.|Wilcoxon rank sum test|||||||0.79
71144424|NCT01018030|141782170|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.357||||0.014|TWO_SIDED|95.0|-0.64|-0.07|||ANCOVA||The estimation for least squares mean was adjusted for baseline value, country, allergic rhinitis status, age, and gender.|||-0.07|-0.64|0.014
70869765|NCT04115839|141225217|SUPERIORITY||Difference in response rates|22.3||||0.035|TWO_SIDED|95.0|-0.7|45.2||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||45.2|-0.7|0.035
70952452|NCT01495598|141406213|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.03||||||The reported p-value is representative of the changes in levels of CD8+ cells/µL among all participants.|Wilcoxon signed rank test|||||||0.03
70952453|NCT01495598|141406213|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.008||||||The reported p-value is representative of the changes in levels of CD8+ cells/µL among all participants.|Wilcoxon signed rank test|||||||0.008
70869766|NCT04115839|141225217|SUPERIORITY||Difference in response rates|12.1||||0.22|TWO_SIDED|95.0|-9.3|33.5||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||33.5|-9.3|0.22
71144425|NCT03164668|141782222|SUPERIORITY||Estimated mean ratio|0.31|||||TWO_SIDED|95.0|0.13|0.72|||||Baseline adjusted model estimated mean ratio in cigarettes smoked per day of those randomized conditions in which menthol cigarettes are avoided relative to conditions in which participants can continue smoking usual cigarettes|Comparison of those assigned to conditions in which menthol cigarettes are avoided relative to conditions in which can continue smoking usual cigarettes||0.72|0.13|
71144426|NCT03164668|141782222|SUPERIORITY||Estimated mean ratio|0.98|||||TWO_SIDED|95.0|0.78|1.22|||||Baseline adjusted model estimated mean ratio in cigarettes smoked per day among those in conditions in which they receive tobacco flavored e-cigarettes relative to conditions in which they receive menthol flavored e-cigarettes|Comparison of those assigned to conditions in which they receive tobacco flavored e-cigarettes relative to conditions in which they receive menthol flavored e-cigarettes||1.22|0.78|
71144427|NCT03164668|141782223|SUPERIORITY||Estimated mean ratio|3.03|||||TWO_SIDED|95.0|1.39|6.61|||||Model estimated mean ratio in puffs of e-cigarettes used per day among those randomized to conditions in which menthol cigarettes are avoided relative to conditions in which participants can continue smoking usual cigarettes|Comparison of those assigned to conditions in which menthol cigarettes are avoided relative to conditions in which can continue smoking usual cigarettes||6.61|1.39|
71144428|NCT03164668|141782223|SUPERIORITY||Estimated mean ratio|0.74|||||TWO_SIDED|95.0|0.59|0.92|||||Estimated mean ratio of number of puffs of e-cigarettes used per day among those in conditions in which they receive tobacco flavored e-cigarettes relative to conditions in which they receive menthol flavored e-cigarettes|Comparison of those assigned to conditions in which they receive tobacco flavored e-cigarettes relative to conditions in which they receive menthol flavored e-cigarettes||0.92|0.59|
71144429|NCT00168844|141782247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry,centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|||||<0.0001
71144430|NCT00168844|141782247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry,centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|||||<0.0001
71144431|NCT00168844|141782248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.269|STANDARD_ERROR_OF_MEAN|0.996||0.0011||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|||||0.0011
71144432|NCT00168844|141782248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.242|STANDARD_ERROR_OF_MEAN|0.999|<|0.0001||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|||||<0.0001
71144433|NCT00168844|141782249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.053|STANDARD_ERROR_OF_MEAN|0.165|<|0.0001|TWO_SIDED|95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|||||<0.0001
71144434|NCT00168844|141782249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.075|STANDARD_ERROR_OF_MEAN|0.166|<|0.0001||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.||||||<0.0001
71144435|NCT00168844|141782250|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.782||||0.0002|TWO_SIDED|95.0|0.687|0.89|||Poisson regression||Tiotropium Respimat 5mcg - Placebo|||0.890|0.687|0.0002
71144436|NCT00168844|141782250|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.725|||<|0.0001|TWO_SIDED|95.0|0.635|0.828|||Poisson regression||Tiotropium Respimat 10mcg - Placebo|||0.828|0.635|<0.0001
71144437|NCT00168844|141782294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry,centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
71144438|NCT00168844|141782294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.323|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry,centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
71144439|NCT00168844|141782295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
71144440|NCT00168844|141782295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.234|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
71144441|NCT00168844|141782296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
71144442|NCT00168844|141782296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.419|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
71144443|NCT00168844|141782297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.5|STANDARD_ERROR_OF_MEAN|5.3|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
71144444|NCT00168844|141782297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.1|STANDARD_ERROR_OF_MEAN|5.3|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
71144445|NCT00168844|141782298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.5|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
71144446|NCT00168844|141782298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.5|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
71144447|NCT00168844|141782299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
70869767|NCT04115839|141225219|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-2.8|2.8|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 4||2.8|-2.8|
71144448|NCT00168844|141782299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
71144449|NCT00988832|141782305|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
71144450|NCT00988832|141782306|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||ANOVA|||||||0.0004
70869768|NCT04115839|141225219|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-2.9|2.9|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 4||2.9|-2.9|
70869769|NCT04115839|141225219|SUPERIORITY||Difference in response rates|3.1|||||TWO_SIDED|95.0|-5.9|12.2|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 8||12.2|-5.9|
70869770|NCT04115839|141225219|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-2.9|2.9|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 8||2.9|-2.9|
70869771|NCT04115839|141225219|SUPERIORITY||Difference in response rates|3.0|||||TWO_SIDED|95.0|-5.8|11.9|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 12||11.9|-5.8|
71144451|NCT00988832|141782307|SUPERIORITY_OR_OTHER|||||||0.0041||95.0|||||ANOVA|||||||0.0041
70952454|NCT01495598|141406213|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.12||||||The reported p-value is representative of the changes in levels of CD8+ cells/µL among all participants.|Wilcoxon signed rank test|||||||0.12
70952455|NCT01495598|141406213|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.02||||||The reported p-value is representative of the changes in levels of CD8+ cells/µL among HIV+ participants.|Wilcoxon signed rank test|||||||0.02
70952456|NCT01495598|141406213|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.02||||||The reported p-value is representative of the changes in levels of CD8+ cells/µL among HIV+ participants.|Wilcoxon signed rank test|||||||0.02
70952457|NCT01495598|141406213|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.36||||||The reported p-value is representative of the changes in levels of CD8+ cells/µL among HIV+ participants.|Wilcoxon signed rank test|||||||0.36
70952458|NCT01495598|141406213|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.002||||||The reported p-value is representative of the changes in levels of CD19+ cells/µL among all participants.|Wilcoxon signed rank test|||||||0.002
70952459|NCT01495598|141406213|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.0002||||||The reported p-value is representative of the changes in levels of CD19+ cells/µL among all participants.|Wilcoxon signed rank test|||||||0.0002
70952460|NCT01495598|141406213|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.|||||<|0.0001||||||The reported p-value is representative of the changes in levels of CD19+ cells/µL among all participants.|Wilcoxon signed rank test|||||||<0.0001
71144452|NCT00988832|141782308|SUPERIORITY_OR_OTHER|||||||0.0423||95.0|||||ANOVA|||||||0.0423
71144453|NCT00988832|141782309|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANOVA|||||||0.0006
71144454|NCT00988832|141782310|SUPERIORITY_OR_OTHER|||||||0.0014||95.0|||||ANOVA|||||||0.0014
71144455|NCT00988832|141782312|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
70952461|NCT01495598|141406214|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.13|||||||Wilcoxon signed rank test|||||||0.13
70952462|NCT01495598|141406214|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.65|||||||Wilcoxon signed rank test|||||||0.65
70952463|NCT01495598|141406214|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.32|||||||Wilcoxon signed rank test|||||||0.32
70952464|NCT01495598|141406214|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.06|||||||Wilcoxon signed rank test|||||||0.06
70952465|NCT01495598|141406214|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.007|||||||Wilcoxon signed rank test|||||||0.007
71144456|NCT01377584|141782316|OTHER||Effect size|-0.51|||||TWO_SIDED|||||||||||||
71144457|NCT01377584|141782316|OTHER||Effect size|-0.42|||||TWO_SIDED|||||||||||||
71144458|NCT01377584|141782316|OTHER||Effect size|-0.82|||||TWO_SIDED|||||||||||||
71144459|NCT01377584|141782316|OTHER||Effect size|-1.31|||||TWO_SIDED|||||||||||||
71144460|NCT01377584|141782316|OTHER||Effect size|-0.08|||||TWO_SIDED|||||||||||||
71144461|NCT01377584|141782316|OTHER||Effect size|-0.77|||||TWO_SIDED|||||||||||||
71144462|NCT01377584|141782317|OTHER||Effect size|0.51|||||TWO_SIDED|||||||||||||
70952466|NCT01495598|141406215|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.56|||||||Wilcoxon signed rank test|||||||0.56
70952467|NCT01495598|141406215|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.65|||||||Wilcoxon signed rank test|||||||0.65
70952468|NCT01495598|141406215|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.56|||||||Wilcoxon signed rank test|||||||0.56
70952469|NCT05140915|141406244|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||||||.77
70952470|NCT03746392|141406268|SUPERIORITY|||||||0.036|||||||Fisher Exact|||||||0.036
70952471|NCT04777864|141406281|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Parent group only||||0.18
70952472|NCT04777864|141406281|SUPERIORITY|||||||0.91|||||||t-test, 2 sided|||Adolescent group only||||0.91
70952473|NCT04777864|141406282|SUPERIORITY|||||||0.975|||||||Regression, Linear|||Parent: Post-Index Visit||||0.975
70952474|NCT04777864|141406282|SUPERIORITY|||||||0.854|||||||Regression, Linear|||Adolescent: Post-Index Visit||||0.854
70952475|NCT04777864|141406285|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Post-Index Visit||||0.03
70952476|NCT04777864|141406285|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||3 months after initial clinic visit||||0.21
70952477|NCT04777864|141406286|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||Baseline||||0.76
70952478|NCT04777864|141406286|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||Post-Index Visit||||0.96
70952479|NCT04777864|141406286|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||3 months after initial clinic visit||||0.96
71144463|NCT01377584|141782317|OTHER||Effect size|0.41|||||TWO_SIDED|||||||||||||
71144464|NCT01377584|141782317|OTHER||Effect size|0.57|||||TWO_SIDED|||||||||||||
71144465|NCT01377584|141782317|OTHER||Effect size|1.54|||||TWO_SIDED|||||||||||||
71144466|NCT01377584|141782317|OTHER||Effect size|0.0|||||TWO_SIDED|||||||||||||
71144467|NCT01377584|141782317|OTHER||Effect size|0.65|||||TWO_SIDED|||||||||||||
71144468|NCT01377584|141782318|OTHER||Effect size|-1.01|||||TWO_SIDED|||||||||||||
71144469|NCT01377584|141782318|OTHER||Effect size|-0.94|||||TWO_SIDED|||||||||||||
71144470|NCT01377584|141782318|OTHER||Effect size|-0.4|||||TWO_SIDED|||||||||||||
71144471|NCT01377584|141782318|OTHER||Effect size|-0.31|||||TWO_SIDED|||||||||||||
71144472|NCT01377584|141782318|OTHER||Effect size|-0.65|||||TWO_SIDED|||||||||||||
71144473|NCT01377584|141782318|OTHER||Effect size|-0.77|||||TWO_SIDED|||||||||||||
71144474|NCT01377584|141782319|OTHER||Effect size|0.52|||||TWO_SIDED||||||||Comparing 1 week to 1 month|||||
71144475|NCT01377584|141782319|OTHER||Effect size|-0.63|||||TWO_SIDED||||||||Comparing 1 month and 3 months|||||
71144476|NCT01377584|141782319|OTHER||Effect size|0.5|||||TWO_SIDED||||||||Comparing 1 week to 1 month|||||
71144477|NCT01377584|141782319|OTHER||Effect size|-0.63|||||TWO_SIDED||||||||Comparing 1 month to 3 months|||||
70952480|NCT05576662|141406287|OTHER||Pooled treatment coefficient|0.026||||0.903|TWO_SIDED|||||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Nonparametric permutation test||Weighted average of treatment coefficients. A pooled treatment coefficient \< 0 favors nirmatrelvir plus ritonavir; a pooled treatment coefficient \> 0 favors placebo plus ritonavir.|A proportional odds logistic regression model was fit for severity of each core symptom at week 10, adjusting for baseline severity of the corresponding symptom and fit using only those who experienced the symptom at baseline. A test statistic for overall efficacy was calculated as the weighted average of the treatment coefficient in the proportional odds model for each symptom with inverse variance weighting. The p-value was obtained by a nonparametric permutation test.||||0.903
71144478|NCT01377584|141782319|OTHER||Effect size|-0.92|||||TWO_SIDED||||||||Comparing 1 week to 1 month|||||
70952481|NCT05576662|141406288|OTHER||Odds Ratio (OR)|1.55||||0.174|TWO_SIDED|95.0|0.82|2.94||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of fatigue score at day 15||2.94|0.82|0.174
70952482|NCT05576662|141406288|OTHER||Odds Ratio (OR)|1.21||||0.548|TWO_SIDED|95.0|0.65|2.25||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of brain fog score at day 15||2.25|0.65|0.548
70952483|NCT05576662|141406288|OTHER||Odds Ratio (OR)|0.62||||0.134|TWO_SIDED|95.0|0.33|1.16||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of dyspnea score at day 15||1.16|0.33|0.134
70952484|NCT05576662|141406288|OTHER||Odds Ratio (OR)|1.45||||0.241|TWO_SIDED|95.0|0.78|2.69||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of body aches score at day 15||2.69|0.78|0.241
70952485|NCT05576662|141406288|OTHER||Odds Ratio (OR)|1.03||||0.922|TWO_SIDED|95.0|0.55|1.92||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of gastrointestinal symptoms score at day 15||1.92|0.55|0.922
71144479|NCT01377584|141782319|OTHER||Effect size|-0.26|||||TWO_SIDED||||||||Comparing 1 month to 3 months|||||
71144480|NCT00844844|141782391|SUPERIORITY_OR_OTHER||LS mean change from baseline|65.18|||<|0.0001|TWO_SIDED|95.0|37.01|93.36|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||With at least 12 patients enrolled and assuming a null hypothesis of no post-dose change from baseline in mean platelet count, the study had approximately 88% power to detect as statistically significant an effect size (mean change from baseline/standard deviation) of at least 1 when using a one sample t-test with a two-sided α=0.05. All analyses were based on the pooled data from the two protocols:C08-002A (adult) and C08-002B (Adolescent), a similar protocol, for patients \<18 years with aHUS.||93.36|37.01|<0.0001
70952486|NCT05576662|141406288|OTHER||Odds Ratio (OR)|0.5||||0.032|TWO_SIDED|95.0|0.26|0.94||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of cardiovascular symptoms score at day 15||0.94|0.26|0.032
70952487|NCT05576662|141406289|OTHER||Odds Ratio (OR)|0.55||||0.09|TWO_SIDED|95.0|0.27|1.09||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|||1.09|0.27|0.09
71144481|NCT00844844|141782392|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|82.0|||||TWO_SIDED|95.0|57.0|96.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||96|57|
71144482|NCT00844844|141782393|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|76.0|||||TWO_SIDED|95.0|50.0|93.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||93|50|
71144483|NCT00844844|141782394|SUPERIORITY_OR_OTHER||Percent of complete TMA response|65.0|||||TWO_SIDED|95.0|38.0|86.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||86|38|
71144484|NCT00844844|141782395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||||<0.0001
71144485|NCT00844844|141782396|SUPERIORITY_OR_OTHER||LS mean change from baseline|111.62|||<|0.0001|TWO_SIDED|95.0|98.12|125.13|||ANOVA|Change from baseline was analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||125.13|98.12|<0.0001
71144486|NCT00844844|141782397|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|88.0|||||TWO_SIDED|95.0|64.0|99.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||99|64|
71144487|NCT00844844|141782398|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|88.0|||||TWO_SIDED|95.0|64.0|99.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||99|64|
70952488|NCT05576662|141406290|OTHER||Odds Ratio (OR)|0.72||||0.6|TWO_SIDED|95.0|0.21|2.44||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|||2.44|0.21|.60
70952489|NCT05576662|141406291|OTHER||Odds Ratio (OR)|1.62||||0.156|TWO_SIDED|95.0|0.83|3.15||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of severity at week 5||3.15|0.83|0.156
70952490|NCT05576662|141406291|OTHER||Odds Ratio (OR)|1.99||||0.03|TWO_SIDED|95.0|1.06|3.72||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of severity at week 10||3.72|1.06|0.03
70952491|NCT05576662|141406291|OTHER||Odds Ratio (OR)|2.42||||0.01|TWO_SIDED|95.0|1.27|4.6||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of severity at week 15||4.60|1.27|0.01
70952492|NCT05576662|141406292|OTHER||Hazard Ratio (HR)|0.9||||0.744|TWO_SIDED|95.0|0.45|1.77||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test||A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.|"Analysis of data for Time to relief - fatigue"||1.77|0.45|0.744
70952493|NCT05576662|141406292|OTHER||Hazard Ratio (HR)|0.67||||0.259|TWO_SIDED|95.0|0.32|1.37||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test||A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.|"Analysis of data for Time to relief - brain fog"||1.37|0.32|0.259
71144488|NCT00844844|141782399|SUPERIORITY_OR_OTHER||Percent of complete TMA response|76.0|||||TWO_SIDED|95.0|50.0|93.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||93|50|
71144489|NCT00844844|141782400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||||<0.0001
71144490|NCT03593044|141782423|OTHER|||||||0.002|||||||t-test, 2 sided|||Photopic pupil size||||0.002
71144491|NCT03593044|141782423|OTHER|||||||0.66|||||||t-test, 2 sided|||Mesopic pupil size||||0.66
71144492|NCT03593044|141782424|OTHER|||||||0.96|||||||t-test, 2 sided|||High contrast distance visual acuity||||0.96
71144493|NCT03593044|141782424|OTHER|||||||0.77|||||||t-test, 2 sided|||High contrast near visual acuity||||0.77
71144494|NCT03593044|141782424|OTHER|||||||0.82|||||||t-test, 2 sided|||Low contrast distance visual acuity||||0.82
71144495|NCT03593044|141782425|OTHER|||||||0.1|||||||t-test, 2 sided|||Accommodative amplitude||||0.10
71144496|NCT03593044|141782425|OTHER|||||||0.66|||||||t-test, 2 sided|||Accommodative lag||||0.66
71144497|NCT03593044|141782425|OTHER|||||||0.24|||||||t-test, 2 sided|||Accommodative facility||||0.24
71144498|NCT03593044|141782426|OTHER|||||||0.3|||||||t-test, 2 sided|||Glare||||0.3
70952494|NCT05576662|141406292|OTHER||Hazard Ratio (HR)|1.61||||0.286|TWO_SIDED|95.0|0.65|3.99||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test||A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.|"Analysis of data for Time to relief - body aches"||3.99|0.65|0.286
70952495|NCT05576662|141406292|OTHER||Hazard Ratio (HR)|0.92||||0.846|TWO_SIDED|95.0|0.38|2.24||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test||A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.|"Analysis of data for Time to relief - cardiovascular symptoms"||2.24|0.38|0.846
70952496|NCT05576662|141406292|OTHER||Hazard Ratio (HR)|1.56||||0.41|TWO_SIDED|95.0|0.51|4.73||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test|A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.||"Analysis of data for Time to relief - shortness of breath"||4.73|0.51|0.410
70952497|NCT05576662|141406292|OTHER||Hazard Ratio (HR)|0.94||||0.88|TWO_SIDED|95.0|0.42|2.11||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test||A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.|"Analysis of data for Time to relief - gastrointestinal symptoms"||2.11|0.42|0.880
71144499|NCT03593044|141782426|OTHER|||||||0.5|||||||t-test, 2 sided|||Ghost images||||0.5
71144500|NCT03593044|141782426|OTHER|||||||0.9|||||||t-test, 2 sided|||Strain/tiredness||||0.9
71144501|NCT03593044|141782426|OTHER|||||||0.9|||||||t-test, 2 sided|||Changing vision||||0.9
71144502|NCT03593044|141782426|OTHER|||||||0.3|||||||t-test, 2 sided|||Headache frequency||||0.3
71144503|NCT03593044|141782426|OTHER|||||||0.7|||||||t-test, 2 sided|||Distance clarity||||0.7
70952498|NCT05576662|141406293|OTHER||Hazard Ratio (HR)|0.74||||0.33|TWO_SIDED|95.0|0.4|1.38||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test||A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.|||1.38|0.40|0.33
70952499|NCT05576662|141406294|OTHER||Mean Difference (Net)|0.57||||0.66|TWO_SIDED|95.0|-1.96|3.1||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors placebo plus ritonavir; a mean difference \> 0 favors nirmatrelvir plus ritonavir.|||3.10|-1.96|.66
70952500|NCT05576662|141406295|OTHER||Mean Difference (Net)|0.38||||0.79|TWO_SIDED|95.0|-2.4|3.15||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|||3.15|-2.40|0.79
70952501|NCT05576662|141406296|OTHER||Mean Difference (Net)|0.6||||0.7|TWO_SIDED|95.0|-2.55|3.75||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|||3.75|-2.55|.70
70952502|NCT05576662|141406297|OTHER||Mean Difference (Net)|0.03||||0.98|TWO_SIDED|95.0|-3.21|3.28||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors placebo plus ritonavir; a mean difference \> 0 favors nirmatrelvir plus ritonavir.|||3.28|-3.21|.98
70952503|NCT05576662|141406298|OTHER||Mean Difference (Net)|1.73||||0.555|TWO_SIDED|95.0|-4.06|7.53||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of data for change of systolic blood pressure||7.53|-4.06|0.555
70952504|NCT05576662|141406298|OTHER||Mean Difference (Net)|-0.68||||0.764|TWO_SIDED|95.0|-5.15|3.79||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of data for change of diastolic blood pressure||3.79|-5.15|0.764
70952505|NCT05576662|141406299|OTHER||Mean Difference (Net)|-0.51||||0.856|TWO_SIDED|95.0|-6.15|5.12||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|||5.12|-6.15|0.856
70952506|NCT05576662|141406300|OTHER||Mean Difference (Net)|-0.41||||0.833|TWO_SIDED|95.0|-4.24|3.42||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors placebo plus ritonavir; a mean difference \> 0 favors nirmatrelvir plus ritonavir.|||3.42|-4.24|0.833
70952507|NCT05576662|141406301|OTHER||Mean Difference (Final Values)|0.32||||0.096|TWO_SIDED|95.0|-0.06|0.7||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of day 15 data||0.70|-0.06|0.096
70952508|NCT05576662|141406301|OTHER||Mean Difference (Final Values)|0.22||||0.293|TWO_SIDED|95.0|-0.2|0.64||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 5 data||0.64|-0.20|0.293
70952509|NCT05576662|141406301|OTHER||Mean Difference (Final Values)|0.19||||0.396|TWO_SIDED|95.0|-0.25|0.62||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 10 data||0.62|-0.25|0.396
70952510|NCT05576662|141406301|OTHER||Mean Difference (Final Values)|0.37||||0.064|TWO_SIDED|95.0|-0.02|0.77||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 15 data||0.77|-0.02|0.064
70952511|NCT05576662|141406302|OTHER||Mean Difference (Final Values)|0.19||||0.444|TWO_SIDED|95.0|-0.3|0.67||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of day 15 data||0.67|-0.30|0.444
70952512|NCT05576662|141406302|OTHER||Mean Difference (Final Values)|-0.25||||0.346|TWO_SIDED|95.0|-0.78|0.28||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 5 data||0.28|-0.78|0.346
70952513|NCT05576662|141406302|OTHER||Mean Difference (Final Values)|0.1||||0.738|TWO_SIDED|95.0|-0.48|0.67||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 10 data||0.67|-0.48|0.738
70952514|NCT05576662|141406302|OTHER||Mean Difference (Final Values)|0.17||||0.578|TWO_SIDED|95.0|-0.43|0.76||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 15 data||0.76|-0.43|0.578
71144504|NCT03593044|141782426|OTHER|||||||0.3|||||||t-test, 2 sided|||Computer clarity||||0.3
71144505|NCT03593044|141782426|OTHER|||||||0.1|||||||t-test, 2 sided|||Small print clarity||||0.1
71144506|NCT03593044|141782426|OTHER|||||||1|||||||t-test, 2 sided|||Vision during sports/hobbies||||1.0
71144507|NCT03593044|141782426|OTHER|||||||0.2|||||||t-test, 2 sided|||Overall vision||||0.2
70952515|NCT05576662|141406303|OTHER||Mean Difference (Final Values)|-0.19||||0.758|TWO_SIDED|95.0|-1.41|1.03||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 5 data||1.03|-1.41|0.758
70952516|NCT05576662|141406303|OTHER||Mean Difference (Final Values)|-0.24||||0.693|TWO_SIDED|95.0|-1.46|0.97||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 10 data||0.97|-1.46|0.693
70952517|NCT05576662|141406303|OTHER||Mean Difference (Final Values)|0.37||||0.558|TWO_SIDED|95.0|-0.87|1.61||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 15 data||1.61|-0.87|0.558
70952518|NCT05576662|141406304|OTHER||Odds Ratio (OR)|0.55||||0.02|TWO_SIDED|95.0|0.33|0.92||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|Post-hoc analysis of fatigue data||0.92|0.33|0.02
70952519|NCT05576662|141406304|OTHER||Odds Ratio (OR)|0.5||||0.01|TWO_SIDED|95.0|0.31|0.82||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|Post-hoc analysis of brain fog data||0.82|0.31|0.01
70952520|NCT05576662|141406304|OTHER||Odds Ratio (OR)|1.32||||0.34|TWO_SIDED|95.0|0.74|2.33||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|Post-hoc analysis of body aches data||2.33|0.74|0.34
70952521|NCT05576662|141406304|OTHER||Odds Ratio (OR)|1.37||||0.29|TWO_SIDED|95.0|0.76|2.48||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|Post-hoc analysis of cardiovascular symptoms data||2.48|0.76|0.29
70952522|NCT05576662|141406304|OTHER||Odds Ratio (OR)|1.32||||0.35|TWO_SIDED|95.0|0.73|2.38||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|Post-hoc analysis of shortness of breath data||2.38|0.73|0.35
70952523|NCT05576662|141406304|OTHER||Odds Ratio (OR)|1.4||||0.25|TWO_SIDED|95.0|0.79|2.47||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|Post-hoc analysis of gastrointestinal symptoms data||2.47|0.79|0.25
70952524|NCT03841526|141406374|OTHER|Parameters that did not meet normality criterion were analyzed non-parametrically. Overall treatment effect was assessed using Friedman's test.||||||0.0002|||||||ANOVA|||The primary efficacy analysis was analyzed by analysis of variance (ANOVA) comparing the mean incidence rates among the 3 treatment groups in the Outpatient Phase. If the performed Friedman's test yielded an overall p-value less than 0.05, post-hoc analysis of groups means were conducted to statistically determine which group means differed.||||0.0002
70952525|NCT03841526|141406374|OTHER||||||<|0.0001|||||||Tukey Test/Kruskal-Wallis Test|Tukey Test (if the difference between 2 treatments was normally distributed) or Kruskal-Wallis Test (if not normally distributed).||If the overall treatment effect was significant, pairwise treatment comparisons were assessed using: If a difference between 2 treatments was normally distributed, the Tukey Test was used or if not normally distributed and the distribution was highly skewed, the sign test/Kruskal-Allis test was used.||||<0.0001
70952526|NCT03841526|141406374|OTHER|||||||0.0032|||||||Tukey Test/Kruskal-Wallis Test|Tukey Test (if the difference between 2 treatments was normally distributed) or Kruskal-Wallis Test (if not normally distributed).||If the overall treatment effect was significant, pairwise treatment comparisons were assessed using: If a difference between 2 treatments was normally distributed, the Tukey Test was used or if not normally distributed and the distribution was highly skewed, the sign test/Kruskal-Allis test was used.||||0.0032
71144508|NCT03593044|141782426|OTHER|||||||0.7|||||||t-test, 2 sided|||Light sensitivity||||0.7
71144509|NCT03593044|141782426|OTHER|||||||0.002|||||||t-test, 2 sided|||Discomfort during bright light||||0.002
71144510|NCT03593044|141782427|OTHER|||||||0.001|||||||t-test, 2 sided|||Right eye intraocular pressure||||0.001
71144511|NCT03593044|141782427|OTHER|||||||0.05|||||||t-test, 2 sided|||Left eye intraocular pressure||||0.05
71144512|NCT02891174|141782442|EQUIVALENCE|margin=10 mmHg|Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-3.7|5.7|||||The adjusted mean difference between ibuprofen and acetaminophen is presented here. The adjusted mean difference was calculated using a linear mixed model adjusting for time period by intention-to-treat principles.|||5.7|-3.7|
71144513|NCT02891174|141782443|SUPERIORITY|||||||0.59||||||Abdominal pain|t-test, 2 sided|||Change in abdominal pain||||0.59
71144514|NCT02891174|141782443|SUPERIORITY|||||||0.91||||||Perineal pain|t-test, 2 sided|||Change in perineal pain||||0.91
71144515|NCT02891174|141782443|SUPERIORITY|||||||0.88||||||Overall pain|t-test, 2 sided|||Change in overall pain||||0.88
70869772|NCT04115839|141225219|SUPERIORITY||Difference in response rates|5.9|||||TWO_SIDED|95.0|-5.0|16.7|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 12||16.7|-5.0|
71144516|NCT02891174|141782444|OTHER|||||||0.76|||||||t-test, 2 sided|||||||0.76
71144517|NCT02891174|141782445|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||First intervention (24 hours)||||0.02
71144518|NCT02891174|141782445|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Second intervention (24 hours)||||0.06
71144519|NCT02891174|141782445|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Overall satisfaction with pain control during study period||||0.04
70869773|NCT04115839|141225219|SUPERIORITY||Difference in response rates|0.1|||||TWO_SIDED|95.0|-11.4|11.6|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 16||11.6|-11.4|
70869774|NCT04115839|141225219|SUPERIORITY||Difference in response rates|3.0|||||TWO_SIDED|95.0|-10.0|16.1|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 16||16.1|-10.0|
70869775|NCT04115839|141225227|SUPERIORITY||LS Mean Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.4||0.24|TWO_SIDED|95.0|-1.0|0.0||P-value was provided from mixed-effects model for repeated measures (MMRM) having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||0|-1|0.24
70869776|NCT04115839|141225227|SUPERIORITY||LS Mean Treatment Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.22|TWO_SIDED|95.0|-1.0|0.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||0|-1|0.22
70869777|NCT04115839|141225227|SUPERIORITY||LS Mean Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.43|TWO_SIDED|95.0|-1.0|1.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 8||1|-1|0.43
70869778|NCT04115839|141225227|SUPERIORITY||LS Mean Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.7|TWO_SIDED|95.0|-1.0|1.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 8||1|-1|0.70
70952527|NCT03841526|141406374|OTHER|||||||0.2072|||||||Tukey Test/Kruskal-Wallis Test|Tukey Test (if the difference between 2 treatments was normally distributed) or Kruskal-Wallis Test (if not normally distributed).||If the overall treatment effect was significant, pairwise treatment comparisons were assessed using: If a difference between 2 treatments was normally distributed, the Tukey Test was used or if not normally distributed and the distribution was highly skewed, the sign test/Kruskal-Allis test was used.||||0.2072
70952528|NCT03841526|141406377|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71144520|NCT02177695|141782460|SUPERIORITY||Odds Ratio (OR)|2.63||||0.1|TWO_SIDED|95.0|0.82|8.36|||Regression, Logistic|||To determine the relationship of GC COXEN scores to pT0, GC COXEN score (dichotomous, favorable vs. unfavorable) was tested in a logistic regression model predicting the outcome of pT0 within the GC treatment group.||8.36|0.82|0.1
71144521|NCT02177695|141782460|SUPERIORITY||Odds Ratio (OR)|1.12||||0.82|TWO_SIDED|95.0|0.42|2.95|||Regression, Logistic|||To determine the relationship of ddMVAC COXEN scores to pT0, ddMVAC COXEN score (dichotomous, favorable vs. unfavorable) was tested in a logistic regression model predicting the outcome of pT0 within the ddMVAC treatment group.||2.95|0.42|0.82
71144522|NCT02177695|141782461|SUPERIORITY||Odds Ratio (OR)|2.33||||0.02|TWO_SIDED|95.0|1.11|4.89|||Regression, Logistic|||To determine the relationship of GC COXEN scores to \<= pT1, GC COXEN score (dichotomous, favorable vs. unfavorable) was tested in a logistic regression model predicting the outcome of pT1 or better within the GC treatment group.||4.89|1.11|0.02
71144523|NCT02177695|141782461|SUPERIORITY||Odds Ratio (OR)|0.9||||0.76|TWO_SIDED|95.0|0.46|1.75|||Regression, Logistic|||To determine the relationship of ddMVAC COXEN scores to \<=pT1, ddMVAC COXEN score (dichotomous, favorable vs. unfavorable) was tested in a logistic regression model predicting the outcome of pT1 or better within the ddMVAC treatment group.||1.75|0.46|0.76
70869779|NCT04115839|141225227|SUPERIORITY||LS Mean Treatment Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.5||0.1|TWO_SIDED|95.0|-2.0|0.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 12||0|-2|0.10
70869780|NCT04115839|141225227|SUPERIORITY||LS Mean Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.9|TWO_SIDED|95.0|-1.0|1.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 12||1|-1|0.90
70869781|NCT04115839|141225227|SUPERIORITY||LS Mean Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.88|TWO_SIDED|95.0|-1.0|1.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||1|-1|0.88
70869782|NCT04115839|141225227|SUPERIORITY||LS Mean Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.89|TWO_SIDED|95.0|-1.0|1.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||1|-1|0.89
70869783|NCT04115839|141225231|SUPERIORITY||Difference in response rates|0.3|||||TWO_SIDED|95.0|-15.9|16.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||16.5|-15.9|
70869784|NCT04115839|141225231|SUPERIORITY||Difference in response rates|12.6|||||TWO_SIDED|95.0|-7.1|32.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||32.3|-7.1|
70869785|NCT04115839|141225231|SUPERIORITY||Difference in response rates|26.6|||||TWO_SIDED|95.0|3.0|50.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||50.2|3.0|
70869786|NCT04115839|141225231|SUPERIORITY||Difference in response rates|18.2|||||TWO_SIDED|95.0|-4.1|40.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||40.4|-4.1|
70869787|NCT04115839|141225233|SUPERIORITY||Difference in response rates|2.9|||||TWO_SIDED|95.0|-5.6|11.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||11.5|-5.6|
70869788|NCT04115839|141225233|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-2.9|2.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||2.9|-2.9|
70869789|NCT04115839|141225233|SUPERIORITY||Difference in response rates|12.9|||||TWO_SIDED|95.0|-2.0|27.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||27.8|-2.0|
70869790|NCT04115839|141225233|SUPERIORITY||Difference in response rates|9.1|||||TWO_SIDED|95.0|-3.7|21.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||21.9|-3.7|
70952529|NCT03841526|141406378|OTHER|||||||0.859|||||||Chi-squared|||||||0.8590
71144524|NCT03583099|141782485|SUPERIORITY||Difference in proportion|4.0||||0.47|TWO_SIDED|95.0|-6.9|15.0|||generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||15.0|-6.9|0.47
71144525|NCT03583099|141782486|SUPERIORITY||Difference in proportion|10.4||||0.05|TWO_SIDED|95.0|0.1|20.7|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||20.7|0.1|0.05
71144526|NCT03583099|141782487|SUPERIORITY||Difference in proportion|1.3||||0.75|TWO_SIDED|95.0|-6.7|9.2|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||9.2|-6.7|0.75
71144527|NCT03583099|141782488|SUPERIORITY||Difference in proportion|-2.7||||0.54|TWO_SIDED|95.0|-11.5|6.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||6.1|-11.5|0.54
70869791|NCT04115839|141225235|SUPERIORITY||Difference in response rates|15.4||||0.098|TWO_SIDED|95.0|-5.5|36.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||36.3|-5.5|0.098
70869792|NCT04115839|141225235|SUPERIORITY||Difference in response rates|-5.1||||0.4|TWO_SIDED|95.0|-21.1|11.0||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||11.0|-21.1|0.40
70869793|NCT04115839|141225235|SUPERIORITY||Difference in response rates|10.8||||0.26|TWO_SIDED|95.0|-12.6|34.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||34.3|-12.6|0.26
70869794|NCT04115839|141225235|SUPERIORITY||Difference in response rates|8.8||||0.39|TWO_SIDED|95.0|-14.6|32.2||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||32.2|-14.6|0.39
70869795|NCT04115839|141225235|SUPERIORITY||Difference in response rates|20.0||||0.088|TWO_SIDED|95.0|-6.9|46.9||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||46.9|-6.9|0.088
71144528|NCT03583099|141782489|SUPERIORITY||Difference in proportion|5.1||||0.16|TWO_SIDED|95.0|-2.1|12.3|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.3|-2.1|0.16
71144529|NCT03583099|141782490|SUPERIORITY||Difference in proportion|-0.6||||0.82|TWO_SIDED|95.0|-6.4|5.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||5.1|-6.4|0.82
70869796|NCT04115839|141225235|SUPERIORITY||Difference in response rates|-7.0||||0.49|TWO_SIDED|95.0|-32.9|18.9||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||18.9|-32.9|0.49
70869797|NCT04115839|141225235|SUPERIORITY||Difference in response rates|28.3||||0.019|TWO_SIDED|95.0|2.4|54.2||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||54.2|2.4|0.019
70952530|NCT03317990|141406462|SUPERIORITY||Mean Difference (Final Values)|3.18|||<|0.0001|TWO_SIDED|95.0|1.62|4.75|||Regression, Linear|||Normal linear regression model adjusted for recruitment site, participant's age, and IIEF-5 at baseline, in participants with available data||4.75|1.62|<0.0001
70952531|NCT03317990|141406463|SUPERIORITY||Mean Difference (Final Values)|-1.41||||0.006|TWO_SIDED|95.0|-2.42|-0.41|||Regression, Linear|||||-0.41|-2.42|0.006
70952532|NCT04833127|141406482|EQUIVALENCE|Null hypothesis: no difference between the groups|Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.56|1.8||generalized linear models (GLM) and generalized estimating equations (GEE) for clustering within recruitment chain|GLM (logit link) with GEE|||||1.80|0.56|1.0
70952533|NCT04833127|141406482|EQUIVALENCE|Null H: No difference between the groups|Odds Ratio (OR)|1.13||||0.69|TWO_SIDED|95.0|0.62|2.07||GLM with GEE to account for clustering by recruitment chain.|GLM (logit link) with GEE|Adjusted for age, education, if has a main male partner, which differed between the two groups at baseline.||||2.07|0.62|0.69
70952534|NCT04833127|141406483|EQUIVALENCE|Null hypothesis: No difference between the groups.|Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.35|2.85|||GLM with GEE|GLM with GEE accounting for clustering by recruitment chain||||2.85|0.35|1.00
70952535|NCT04833127|141406483|EQUIVALENCE|Null H: No difference between the 2 groups|Odds Ratio (OR)|0.95||||0.927|TWO_SIDED|95.0|0.31|2.9||GLM (logit link) with GEE to account for clustering by recruitment chain|GLM (logit link) with GEE|adjusted for baseline differences in age, educational status, and whether has a primary male partner.||||2.90|0.31|0.927
70952536|NCT04833127|141406484|EQUIVALENCE|Null Hypothesis: No difference between the groups|Odds Ratio (OR)|1.72||||0.215|TWO_SIDED|95.0|0.73|4.04|||GLM (logit link) with GEE|Used GEE to account for clustering by recruitment chain.||||4.04|0.73|0.215
70952537|NCT04833127|141406484|EQUIVALENCE|Null hypothesis: No difference between the groups|Odds Ratio (OR)|1.64||||0.295|TWO_SIDED|95.0|0.65|4.13|||GLM (logit link) with GEE|GEE used to account for clustering by recruitment chain|adjusted for baseline differences in age, education, and whether has a main male partner.|||4.13|0.65|0.295
70952538|NCT04552899|141406489|SUPERIORITY||Difference in Change from Baseline|-20.83|STANDARD_ERROR_OF_MEAN|34.11||0.54|TWO_SIDED|95.0|-87.94|46.29|||RCRM|Random Coefficient Regression Model (RCRM)||||46.29|-87.94|0.54
70952539|NCT04552899|141406492|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.2512|TWO_SIDED|95.0|0.91|1.47|||Log Rank|||||1.47|0.91|0.2512
70952540|NCT04552899|141406493|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9833|TWO_SIDED|95.0|0.51|1.97|||Log Rank|||||1.97|0.51|0.9833
70952541|NCT04552899|141406496|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.7005|TWO_SIDED|95.0|0.4|1.86|||Log Rank|||||1.86|0.40|0.7005
70952542|NCT00731133|141406562|SUPERIORITY_OR_OTHER||Slope|2.6466|STANDARD_ERROR_OF_MEAN|0.9016||0.05|TWO_SIDED|95.0|0.7858|4.5073|||Mixed Models Analysis|7,24||Open-label study testing for change in side-effects ratings over time (i.e., slope).||4.5073|.7858|0.05
70952543|NCT00731133|141406563|SUPERIORITY_OR_OTHER||Slope|-0.373|STANDARD_ERROR_OF_MEAN|0.2196||0.05|TWO_SIDED|95.0|-0.8075|0.0615|||Mixed Models Analysis|7,24||Open label study testing changes in amphetamine use over time (i.e., slope).||0.06150|-0.8075|0.05
70952544|NCT03098563|141406585|SUPERIORITY|||||||0.021|||||||ANOVA|||||||.021
70952545|NCT02964325|141406591|NON_INFERIORITY|An NI analysis was carried out to assess the primary efficacy endpoint with the null hypothesis being the MIRASOL group is inferior to the CONTROL group and the alternative hypothesis being the MIRASOL group is non-inferior to the CONTROL group. In this study, the NI margin was 1.6.|Relative Rate|2.79|||||TWO_SIDED|95.0|1.67|4.67|||||The MIRASOL group represents the numerator and the CONTROL group represents the denominator for the relative rate. For days during off-protocol intervals, bleeding data were simulated using an estimate of the individual-specific bleeding rate.|The MIRASOL and CONTROL groups were compared with respect to the number of days of WHO ≥ Grade 2 bleeding. This was carried out by fitting a negative binomial regression model with an offset defined as the natural logarithm (LN) of the number of days that bleeding was assessed in order to account for the fact that subjects had different numbers of bleeding assessment days.||4.67|1.67|
70952546|NCT02964325|141406593|NON_INFERIORITY|A non-inferiority margin of 1.2 was used to evaluated this endpoint.|Relative Risk|1.32||||0.7274|TWO_SIDED|95.0|0.97|1.81|||Wald Non-inferiority Test||The MIRASOL group represents the numerator and the CONTROL group represents the denominator for the relative risk.|The null hypothesis was H0: pt/pc \> 1.2 (ie, MIRASOL had more than a 20% higher probability of a patient experiencing at least one WHO ≥ Grade 2 bleed compared to CONTROL).||1.81|0.97|0.7274
70952547|NCT02964325|141406594|OTHER|||||||0.07|||||||Log-rank test|||||||0.07
70952548|NCT02964325|141406595|OTHER|||||||0.1649|||||||Fisher Exact|||||||0.1649
70952549|NCT02964325|141406596|OTHER||Risk Ratio (RR)|2.15||||0.0015|TWO_SIDED|95.0|1.32|3.49|||Fisher Exact|||||3.49|1.32|0.0015
70952550|NCT02551653|141406628|OTHER||Mean Ratio|0.832|||||TWO_SIDED|95.0|0.682|0.979|||||||Volume of Distribution - Heart, Left Ventricular Wall: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.|0.979|0.682|
70952551|NCT02551653|141406628|OTHER||Mean Ratio|1.472|||||TWO_SIDED|95.0|1.113|1.891|||||||Volume of Distribution - Heart, Right Ventricular Wall: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.|1.891|1.113|
70952552|NCT02551653|141406628|OTHER||Mean Ratio|0.958|||||TWO_SIDED|95.0|0.692|1.241|||||||Volume of Distribution - Lung: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.|1.241|0.692|
70952553|NCT02551653|141406629|OTHER||Mean Ratio|1.013|||||TWO_SIDED|95.0|0.846|1.189|||||||Mean Standardized Uptake Values - Heart, Left Ventricular Wall: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.|1.189|0.846|
70952554|NCT02551653|141406629|OTHER||Mean Ratio|1.056|||||TWO_SIDED|95.0|0.853|1.269|||||||Mean Standardized Uptake Values - Heart, Right Ventricular Wall: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.|1.269|0.853|
70952555|NCT02551653|141406629|OTHER||Mean Ratio|1.047|||||TWO_SIDED|95.0|0.786|1.34|||||||Mean Standardized Uptake Values - Lung: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.|1.340|0.786|
70952556|NCT04145700|141406669|SUPERIORITY||Posterior Mean Hazard Ratio|2.62||||0.051|TWO_SIDED|80.0|1.19|4.46|||Bayesian hierarchical model|||To conclude success for the intervention, the Bayesian analysis must yield a minimum of 99% posterior probability for PFS Hazard ratio less than 1 \[i.e., Pr(HR \< 1) \> 99%\]. The Bayesian analyses below include posterior mean of Hazard ratio, posterior probabilities instead of p-values, and credible intervals instead of confidence intervals.||4.46|1.19|0.051
70952557|NCT04978493|141406681|OTHER||Difference of adjusted means|1.92|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|95.0|-0.99|4.84|||||(Adjusted mean BI 706321 and ustekinumab) - (adjusted mean Placebo and ustekinumab)|The analysis was a restricted maximum likelihood (REML) based analysis of covariance (ANCOVA). For the ANCOVA model, absolute change in SES-CD score was the dependent variable, treatment group and baseline corticosteroid use (yes/no) were fixed effects and baseline SES-CD score was a continuous covariate.||4.84|-0.99|
70952558|NCT04978493|141406682|OTHER||Difference of adjusted means|13.34|STANDARD_ERROR_OF_MEAN|11.32|||TWO_SIDED|95.0|-9.46|36.14|||||(Adjusted mean BI 706321 and ustekinumab) - (adjusted mean Placebo and ustekinumab)|The analysis was a restricted maximum likelihood (REML) based analysis of covariance (ANCOVA). For the ANCOVA model, absolute change in SES-CD score was the dependent variable, treatment group and baseline corticosteroid use (yes/no) were fixed effects and baseline SES-CD score was a continuous covariate.||36.14|-9.46|
70952559|NCT04978493|141406683|OTHER||Unadjusted risk difference|-27.5|||||TWO_SIDED|95.0|-48.42|-2.64|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||-2.64|-48.42|
70952560|NCT04978493|141406684|OTHER||Unadjusted risk difference|0.67|||||TWO_SIDED|95.0|-20.49|22.12|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||22.12|-20.49|
70952561|NCT04978493|141406685|OTHER||Unadjusted risk difference|-3.83|||||TWO_SIDED|95.0|-21.14|13.25|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||13.25|-21.14|
70952562|NCT04978493|141406686|OTHER||Unadjusted risk difference|0.33|||||TWO_SIDED|95.0|-17.67|18.78|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||18.78|-17.67|
70952563|NCT04978493|141406687|OTHER||Unadjusted risk difference|-3.33|||||TWO_SIDED|95.0|-24.91|18.85|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||18.85|-24.91|
70952564|NCT04978493|141406688|OTHER||Unadjusted risk difference|-3.5|||||TWO_SIDED|95.0|-23.86|17.34|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||17.34|-23.86|
70952565|NCT04978493|141406689|OTHER||Unadjusted risk difference|-18.5|||||TWO_SIDED|95.0|-42.32|8.89|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||8.89|-42.32|
70952566|NCT04978493|141406690|OTHER||Unadjusted risk difference|0.83|||||TWO_SIDED|95.0|-21.53|23.41|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||23.41|-21.53|
70952567|NCT04978493|141406691|OTHER||Unadjusted risk difference|-22.17|||||TWO_SIDED|95.0|-45.42|5.19|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||5.19|-45.42|
70952568|NCT01327846|141406693|SUPERIORITY|A HR \< 1 favors Canakinumab|Cox Proportional Hazard|0.86||||0.0648|TWO_SIDED|95.0|0.75|0.99||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank||MACE|H11: The hazard rate of first adjudication committee confirmed MACE in the canakinumab 300 mg dose group is greater than or equal to the hazard rate of the placebo group||0.99|0.75|0.0648
70952569|NCT01327846|141406693|SUPERIORITY|A HR \< 1 favors Canakinumab|Cox Proportional Hazard|0.85||||0.0241|TWO_SIDED|95.0|0.74|0.98||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank||MACE|H21: The hazard rate of first adjudication committee confirmed MACE in the canakinumab 150 mg dose group is greater than or equal to the hazard rate of the placebo group||0.98|0.74|0.0241
70952570|NCT01327846|141406693|SUPERIORITY|A HR \< 1 favors Canakinumab|Cox Proportional Hazard|0.93||||0.1895|TWO_SIDED|95.0|0.8|1.07||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank||MACE|H31: The hazard rate of first adjudication committee confirmed MACE in the canakinumab 50 mg dose group is greater than or equal to the hazard rate of the placebo group.||1.07|0.80|0.1895
70952571|NCT01327846|141406693|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.94||||0.572|TWO_SIDED|95.0|0.77|1.16||2-sided unadjusted p-value|Regression, Cox||CV death|||1.16|0.77|0.572
70952572|NCT01327846|141406693|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.9||||0.296|TWO_SIDED|95.0|0.73|1.1||2-sided unadjusted p-value|Regression, Cox||CV death|||1.10|0.73|0.296
70952573|NCT01327846|141406693|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.91||||0.369|TWO_SIDED|95.0|0.73|1.12||2-sided unadjusted p-value|Regression, Cox||CV death|||1.12|0.73|0.369
70952574|NCT01327846|141406693|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.84||||0.067|TWO_SIDED|95.0|0.69|1.01||2-sided unadjusted p-value|Regression, Cox||MI (fatal and non-fatal)|||1.01|0.69|0.067
70952575|NCT01327846|141406693|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.76||||0.006|TWO_SIDED|95.0|0.63|0.92||2-sided unadjusted p-value|Regression, Cox||MI (fatal and non-fatal)|||0.92|0.63|0.006
70952576|NCT01327846|141406693|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.94||||0.542|TWO_SIDED|95.0|0.78|1.14||2-sided unadjusted p-value|Regression, Cox||MI (fatal and non-fatal)|||1.14|0.78|0.542
70952577|NCT01327846|141406693|OTHER|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.68|1.0|||||MI (non-fatal)|||1.00|0.68|
70952578|NCT01327846|141406693|OTHER|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.62|0.92|||||MI (non-fatal)|||0.92|0.62|
70952579|NCT01327846|141406693|OTHER|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.78|1.14|||||MI (non-fatal)|||1.14|0.78|
70952580|NCT01327846|141406693|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.8||||0.19|TWO_SIDED|95.0|0.56|1.12||2-sided unadjusted p-value|Regression, Cox||Stroke (fatal and non-fatal)|||1.12|0.56|0.190
70952581|NCT01327846|141406693|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.98||||0.912|TWO_SIDED|95.0|0.71|1.35||2-sided unadjusted p-value|Regression, Cox||Stroke (fatal and non-fatal)|||1.35|0.71|0.912
70952582|NCT01327846|141406693|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|1.03||||0.871|TWO_SIDED|95.0|0.74|1.43||2-sided unadjusted p-value|Regression, Cox||Stroke (fatal and non-fatal)|||1.43|0.74|0.871
71144530|NCT03583099|141782491|SUPERIORITY||Difference in proportion|-6.3||||0.06|TWO_SIDED|95.0|-13.0|0.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||0.4|-13.0|0.06
70952583|NCT01327846|141406693|OTHER|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.57|1.13|||||Stroke (nonfatal)|||1.13|0.57|
71144531|NCT03583099|141782492|SUPERIORITY||Difference in proportion|-2.5||||0.68|TWO_SIDED|95.0|-14.5|9.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||9.5|-14.5|0.68
71144532|NCT03583099|141782493|SUPERIORITY||Difference in proportion|13.3||||0.19|TWO_SIDED|95.0|-6.72|33.38|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||33.38|-6.72|0.19
70952584|NCT01327846|141406693|OTHER|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.72|1.37|||||Stroke (nonfatal)|||1.37|0.72|
71144533|NCT03583099|141782494|SUPERIORITY||Difference in proportion|0.85||||0.93|TWO_SIDED|95.0|-17.82|19.52|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||19.52|-17.82|0.93
71144534|NCT03583099|141782495|SUPERIORITY||Difference in proportion|6.83||||0.45|TWO_SIDED|95.0|-10.84|24.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||24.50|-10.84|0.45
71144535|NCT03583099|141782496|SUPERIORITY||Difference in proportion|7.6||||0.41|TWO_SIDED|95.0|-10.58|25.78|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||25.78|-10.58|0.41
70952585|NCT01327846|141406693|OTHER|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.75|1.45|||||Stroke (nonfatal)|||1.45|0.75|
71144536|NCT03583099|141782497|SUPERIORITY||Difference in proportion|1.85||||0.81|TWO_SIDED|95.0|-13.17|16.88|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||16.88|-13.17|0.81
70952586|NCT01327846|141406696|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.82||||0.0648|TWO_SIDED|95.0|0.72|0.94||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank||MACE or unstable angina|||0.94|0.72|0.0648
70952587|NCT01327846|141406696|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.83||||0.0241|TWO_SIDED|95.0|0.73|0.95||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank||MACE or unstable angina|||0.95|0.73|0.0241
70952588|NCT01327846|141406696|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.9||||0.1895|TWO_SIDED|95.0|0.79|1.03||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank||MACE or unstable angina|||1.03|0.79|0.1895
70952589|NCT01327846|141406696|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.58||||0.007|TWO_SIDED|95.0|0.39|0.86||2-sided unadjusted p-value|Regression, Cox||unstable angina|||0.86|0.39|0.007
71144537|NCT03583099|141782498|SUPERIORITY||Difference in proportion|8.01||||0.51|TWO_SIDED|95.0|-15.38|31.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||31.40|-15.38|0.51
71144538|NCT03583099|141782499|SUPERIORITY||Difference in proportion|-10.34||||0.41|TWO_SIDED|95.0|-34.78|14.09|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||14.09|-34.78|0.41
71144539|NCT03583099|141782500|SUPERIORITY||Difference in proportion|-3.94||||0.76|TWO_SIDED|95.0|-31.03|23.16|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||23.16|-31.03|0.76
71144540|NCT03583099|141782501|SUPERIORITY||Difference in proportion|-0.76||||0.95|TWO_SIDED|95.0|-25.36|23.83|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||23.83|-25.36|0.95
71144541|NCT03583099|141782502|SUPERIORITY||Difference in means|-0.32||||0.55|TWO_SIDED|95.0|-2.01|1.36||The p-value is adjusted for baseline CAT score.|Mixed Models Analysis||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||1.36|-2.01|0.55
71144542|NCT03583099|141782503|SUPERIORITY||Difference in proportion|8.7||||0.05|TWO_SIDED|95.0|-0.1|17.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||17.4|-0.1|0.05
71144543|NCT03583099|141782504|SUPERIORITY||Difference in proportion|1.81||||0.88|TWO_SIDED|95.0|-21.47|25.08|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||25.08|-21.47|0.88
71144544|NCT03583099|141782505|SUPERIORITY||Difference in proportion|-5.62||||0.53|TWO_SIDED|95.0|-23.21|11.97|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||11.97|-23.21|0.53
71144545|NCT03583099|141782506|SUPERIORITY||Difference in proportion|10.68||||0.24|TWO_SIDED|95.0|-7.27|28.63|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||28.63|-7.27|0.24
71144546|NCT03583099|141782507|SUPERIORITY||Difference in proportion|-13.55||||0.19|TWO_SIDED|95.0|-33.65|6.55|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.55|-33.65|0.19
71144547|NCT03583099|141782508|SUPERIORITY||Difference in proportion|0.38||||0.95|TWO_SIDED|95.0|-12.5|13.27|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.27|-12.50|0.95
71144548|NCT03583099|141782509|SUPERIORITY||Difference in proportion|-6.97||||0.14|TWO_SIDED|95.0|-16.12|2.17|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||2.17|-16.12|0.14
71144549|NCT03583099|141782510|SUPERIORITY||Difference in proportion|-1.06||||0.87|TWO_SIDED|95.0|-13.39|11.27|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||11.27|-13.39|0.87
71144550|NCT03583099|141782511|SUPERIORITY||Difference in proportion|-1.8||||0.81|TWO_SIDED|95.0|-15.9|12.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.4|-15.9|0.81
71144551|NCT03583099|141782512|SUPERIORITY||Difference in proportion|2.3||||0.63|TWO_SIDED|95.0|-7.2|11.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||11.8|-7.2|0.63
71144552|NCT03583099|141782513|SUPERIORITY||Difference in proportion|5.8||||0.17|TWO_SIDED|95.0|-2.5|14.2|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||14.2|-2.5|0.17
70952590|NCT01327846|141406696|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.64||||0.022|TWO_SIDED|95.0|0.44|0.94||2-sided unadjusted p-value|Regression, Cox||unstable angina|||0.94|0.44|0.022
70952591|NCT01327846|141406696|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.71||||0.086|TWO_SIDED|95.0|0.48|1.05||2-sided unadjusted p-value|Regression, Cox||unstable angina|||1.05|0.48|0.086
70952592|NCT01327846|141406697|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|1.01||||0.8456|TWO_SIDED|95.0|0.83|1.23||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank|||||1.23|0.83|0.8456
70952593|NCT01327846|141406697|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|1.06||||0.8456|TWO_SIDED|95.0|0.87|1.29||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank|||||1.29|0.87|0.8456
70952594|NCT01327846|141406697|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.98||||0.6541|TWO_SIDED|95.0|0.8|1.2||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank|||||1.20|0.80|0.6541
70952595|NCT01327846|141406698|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.028|TWO_SIDED|95.0|0.77|0.99||2-sided unadjusted p-value|Regression, Cox||All-cause mortality or MI or Stroke|||0.99|0.77|0.028
70952596|NCT01327846|141406698|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.011|TWO_SIDED|95.0|0.75|0.96||2-sided unadjusted p-value|Regression, Cox||All-cause mortality or MI or Stroke|||0.96|0.75|0.011
70952597|NCT01327846|141406698|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.377|TWO_SIDED|95.0|0.83|1.07||2-sided unadjusted p-value|Regression, Cox||All-cause mortality or MI or Stroke|||1.07|0.83|0.377
70952598|NCT01327846|141406699|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.93||||0.406|TWO_SIDED|95.0|0.79|1.1||2-sided unadjusted p-value|Regression, Cox||All-cause mortality|||1.10|0.79|0.406
70952599|NCT01327846|141406699|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.92||||0.329|TWO_SIDED|95.0|0.78|1.09||2-sided unadjusted p-value|Regression, Cox||All-cause mortality|||1.09|0.78|0.329
70952600|NCT01327846|141406699|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.96||||0.597|TWO_SIDED|95.0|0.81|1.13||2-sided unadjusted p-value|Regression, Cox||All-cause mortality|||1.13|0.81|0.597
70952601|NCT04608773|141406775|SUPERIORITY||||||<|0.501|||||||ANCOVA|||Null hypothesis is that there was no difference in change of Dry mouth score between Refresh and Biotene. ANCOVA model was performed by regressing the difference in after-treatment measurement between Refresh and Biotene over the difference of baseline between Refresh and Biotene. The test was performed with a significance level of 0.05 (two- sided)||||<0.501
70869798|NCT04115839|141225235|SUPERIORITY||Difference in response rates|2.9||||0.85|TWO_SIDED|95.0|-22.5|28.4||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||28.4|-22.5|0.85
70952602|NCT04608773|141406776|SUPERIORITY|||||||0.109|||||||ANCOVA|||||||.109
70952603|NCT04608773|141406777|SUPERIORITY|||||||0.107|||||||ANCOVA|||||||.107
70952604|NCT04608773|141406778|SUPERIORITY|||||||0.489|||||||ANCOVA|||||||.489
70952605|NCT04608773|141406779|SUPERIORITY|||||||0.213|||||||ANCOVA|||||||.213
70952606|NCT04608773|141406780|SUPERIORITY|||||||0.486|||||||ANCOVA|||||||.486
70952607|NCT02387970|141406782|SUPERIORITY|||||||0.088|||||||t-test, 2 sided|||||||0.088
70952608|NCT02387970|141406783|SUPERIORITY|||||||0.235|||||||t-test, 2 sided|||||||0.235
70952609|NCT02387970|141406784|SUPERIORITY|||||||0.165|||||||t-test, 2 sided|||||||0.165
70952610|NCT02387970|141406785|SUPERIORITY|||||||0.297|||||||t-test, 2 sided|||||||0.297
70952611|NCT02387970|141406786|SUPERIORITY|||||||0.121|||||||t-test, 2 sided|||||||0.121
70952612|NCT02387970|141406787|SUPERIORITY|||||||0.248|||||||t-test, 2 sided|||||||0.248
70952613|NCT02387970|141406788|SUPERIORITY|||||||0.854|||||||t-test, 2 sided|||||||0.854
70952614|NCT01310231|141406789|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.71|TWO_SIDED|95.0|0.63|2.31||One-sided p-value for group-effect obtained from Cox model. The prespecified threshold was 0.20 (one-sided).|Regression, Cox|Cox model for PFS with metf/plac and the two randomization stratification variables line of chemotherapy and hormone receptor status.|Ratio of hazard of progression in the Metformin group relative to hazard in the Placebo group|Power: Final study plan called for 40 progression events, giving 80% power to detect a hazard ratio (HR) of 0.58 for PFS with a one-sided type I error of 20%, where the relatively high type I error reflects the Phase II status of the trial||2.31|0.63|0.71
70952615|NCT01310231|141406790|SUPERIORITY||Odds Ratio (OR)|1.77||||0.41|TWO_SIDED|95.0|0.45|6.99||Two-side p-value from a logistic regression model.|Regression, Logistic|Logistic regression model included metf/plac and the two stratification variables line of chemotherapy and hormone receptor status.||||6.99|0.45|0.41
70952616|NCT04662060|141406799|OTHER||Hazard Ratio (HR)|0.6||||0.07|TWO_SIDED|95.0|0.34|1.04||A p-value of \<0.05 would be considered statistically significant.|Cox proportional hazards model|Two-sided Cox proportional hazards model adjusted for age, sex, and receipt of baseline receipt of monoclonal antibodies.||A two-sided log rank test at the 0.04999 level of significance for the final analysis required 78 events (i.e., sustained symptom resolution) to provide 80% power to detect a hazard ratio of 1.91. Based on previous outpatient COVID-19 trials at Stanford, assumed placebo and treatment arm median time to symptom resolution of 10 and 5 days, respectively, for a total sample size of 120 patients. Participants with missing data lasting through Day 28 were censored on Day 28.||1.04|0.34|0.07
70952617|NCT04662060|141406800|OTHER|||||||0.2||||||A p-value of \<0.05 would be considered statistically significant.|Linear mixed-effects regression model|||A generalized linear mixed effects model with parameterization was utilized to capture the difference in change in viral shedding at day 10 between treatment arms. SARS-CoV2 viral RNA CT values were transformed using a standard Reference curve.||||0.20
70952618|NCT04662060|141406802|OTHER||Hazard Ratio (HR)|0.62||||0.05|TWO_SIDED|95.0|0.38|1.01|||Linear mixed-effects regression model|||||1.01|0.38|0.05
70952619|NCT04662060|141406803|OTHER||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.34|1.01||||||||1.01|0.34|
70952620|NCT04662060|141406804|OTHER|||||||0.21||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||Difference in incidence of ED visits||||0.21
70952621|NCT00316017|141406809|SUPERIORITY_OR_OTHER|||||||0.91||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who survived to day 28 day between the three groups.||||0.91
70952622|NCT00316017|141406810|SUPERIORITY_OR_OTHER|||||||0.94||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in ARDS-free survival through day 28 between the three groups.||||0.94
70952623|NCT00316017|141406811|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in average Worst Multiple Organ Dysfunction Scores (MODS) through day 28 between the three groups.||||0.73
70952624|NCT00316017|141406812|SUPERIORITY_OR_OTHER|||||||0.8||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients with the Presence of Nosocomial Infection through day 28 between the three groups.||||0.8
70952625|NCT00316017|141406813|SUPERIORITY_OR_OTHER|||||||0.69||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in the average number of PRBC units given within the first 24 hours between the three groups.||||0.69
70952626|NCT00316017|141406814|SUPERIORITY_OR_OTHER|||||||0.57||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in the average amount of Total fluids given within the first 24 hours between the three groups.||||0.57
70952627|NCT00316017|141406815|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in the average number of Ventilator-free days through day 28 between the three groups.||||0.66
70952628|NCT00316017|141406816|SUPERIORITY_OR_OTHER|||||||0.82||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in the average number of Days alive out of the ICU through day 28 between the three groups.||||0.82
70952629|NCT00316017|141406817|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in the average number of Days alive out of the hospital through day 28 between the three groups.||||0.98
70952630|NCT00316017|141406818|SUPERIORITY_OR_OTHER|||||||0.85||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who survived to hospital discharge between the three groups.||||0.85
70952631|NCT00316017|141406819|SUPERIORITY_OR_OTHER|||||||0.48||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who received zero units of PRBC in the first 24 hours between the three groups.||||0.48
70952632|NCT00316017|141406820|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died in field or ED between the three groups among the patients who received zero units of PRBC.||||<0.01
70952633|NCT00316017|141406821|SUPERIORITY_OR_OTHER||||||<|0.02||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in percent of patients who died within 6 hours of admission to the hospital between the three groups among patients who received zero units of PRBC.||||<0.02
70952634|NCT00316017|141406822|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died within 28 days from the time of the 911 call between the three groups among the patients who received zero units of PRBC.||||<0.01
70952635|NCT00316017|141406823|SUPERIORITY_OR_OTHER|||||||0.51||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who received 1-9 units PRBC in the first 24 hours between the three groups.||||0.51
70952636|NCT00316017|141406824|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died in Field or ED between the three groups among the patients who received 1-9 units of PRBC.||||0.73
71144553|NCT03583099|141782514|SUPERIORITY||Difference in proportion|-2.9||||0.58|TWO_SIDED|95.0|-13.0|7.3|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.3|-13.0|0.58
71144554|NCT03583099|141782515|SUPERIORITY||Difference in proportion|-0.6||||0.89|TWO_SIDED|95.0|-8.3|7.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.1|-8.3|0.89
71144555|NCT03583099|141782516|SUPERIORITY||Difference in proportion|-3.9||||0.16|TWO_SIDED|95.0|-9.2|1.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||1.5|-9.2|0.16
71144556|NCT03583099|141782517|SUPERIORITY||Difference in proportion|-2.2||||0.62|TWO_SIDED|95.0|-10.9|6.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.5|-10.9|0.62
71144557|NCT03583099|141782518|SUPERIORITY||Difference in proportion|-1.64||||0.84|TWO_SIDED|95.0|-17.27|13.99|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.99|-17.27|0.84
71144558|NCT03583099|141782519|SUPERIORITY||Difference in proportion|6.09||||0.27|TWO_SIDED|95.0|-4.63|16.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||16.80|-4.63|0.27
71144559|NCT03583099|141782520|SUPERIORITY||Difference in proportion|2.91||||0.55|TWO_SIDED|95.0|-6.59|12.41|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.41|-6.59|0.55
71144560|NCT03583099|141782521|SUPERIORITY||Difference in proportion|2.37||||0.69|TWO_SIDED|95.0|-9.09|13.83|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.83|-9.09|0.69
71144561|NCT03583099|141782522|SUPERIORITY||Difference in proportion|0.36||||0.93|TWO_SIDED|95.0|-8.13|8.85|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||8.85|-8.13|0.93
71144562|NCT03583099|141782523|SUPERIORITY||Difference in proportion|-4.01||||0.26|TWO_SIDED|95.0|-10.97|2.95|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||2.95|-10.97|0.26
70869799|NCT04115839|141225235|SUPERIORITY||Difference in response rates|25.9||||0.036|TWO_SIDED|95.0|-0.4|52.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||52.3|-0.4|0.036
71144563|NCT03583099|141782524|SUPERIORITY||Difference in proportion|-2.04||||0.74|TWO_SIDED|95.0|-14.28|10.21|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||10.21|-14.28|0.74
71144564|NCT03583099|141782525|SUPERIORITY||Difference in proportion|0.1||||0.98|TWO_SIDED|95.0|-7.9|8.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||8.1|-7.9|0.98
71144565|NCT03583099|141782526|SUPERIORITY||Difference in proportion|2.6||||0.46|TWO_SIDED|95.0|-4.3|9.6|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||9.6|-4.3|0.46
71144566|NCT03583099|141782527|SUPERIORITY||Difference in proportion|1.5||||0.5|TWO_SIDED|95.0|-3.0|6.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.1|-3.0|0.50
71144567|NCT03583099|141782528|SUPERIORITY||Difference in proportion|-0.2||||0.96|TWO_SIDED|95.0|-6.8|6.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.5|-6.8|0.96
71144568|NCT03583099|141782529|SUPERIORITY||Difference in proportion|2.2||||0.4|TWO_SIDED|95.0|-3.0|7.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.5|-3.0|0.40
70869800|NCT04115839|141225235|SUPERIORITY||Difference in response rates|6.1||||0.6|TWO_SIDED|95.0|-19.7|31.8||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||31.8|-19.7|0.60
71144569|NCT03583099|141782530|SUPERIORITY||Difference in proportion|-0.1||||0.96|TWO_SIDED|95.0|-4.3|4.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||4.0|-4.3|0.96
71144570|NCT03583099|141782531|SUPERIORITY||Difference in proportion|0.1||||0.98|TWO_SIDED|95.0|-7.9|8.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||8.1|-7.9|0.98
71144571|NCT03583099|141782532|SUPERIORITY||Difference in proportion|-4.2||||0.46|TWO_SIDED|95.0|-15.2|6.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.8|-15.2|0.46
71144572|NCT03583099|141782533|SUPERIORITY||Difference in proportion|3.9||||0.37|TWO_SIDED|95.0|-4.7|12.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.4|-4.7|0.37
71144573|NCT03583099|141782534|SUPERIORITY||Difference in proportion|-0.8||||0.75|TWO_SIDED|95.0|-6.0|4.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||4.4|-6.0|0.75
70869801|NCT04115839|141225237|SUPERIORITY||Difference in response rates|6.0||||0.31|TWO_SIDED|95.0|-7.8|19.8||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||19.8|-7.8|0.31
71144574|NCT03583099|141782535|SUPERIORITY||Difference in proportion|-8.7||||0.08|TWO_SIDED|95.0|-18.3|0.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||0.9|-18.3|0.08
71144575|NCT03583099|141782536|SUPERIORITY||Difference in proportion|-4.8||||0.11|TWO_SIDED|95.0|-10.6|1.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||1.1|-10.6|0.11
71144576|NCT03583099|141782537|SUPERIORITY||Difference in proportion|0.4||||0.89|TWO_SIDED|95.0|-5.1|5.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||5.9|-5.1|0.89
71144577|NCT03583099|141782538|SUPERIORITY||Difference in proportion|-8.8||||0.05|TWO_SIDED|95.0|-17.5|0.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||-0.0|-17.5|0.05
71144578|NCT03583099|141782539|SUPERIORITY||Difference in proportion|16.76||||0.09|TWO_SIDED|95.0|-2.89|36.42|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||36.42|-2.89|0.09
71144579|NCT03583099|141782540|SUPERIORITY||Difference in proportion|3.7||||0.56|TWO_SIDED|95.0|-8.6|15.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||15.9|-8.6|0.56
71144580|NCT03583099|141782541|SUPERIORITY||Difference in proportion|10.41||||0.49|TWO_SIDED|95.0|-19.39|40.2|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||40.20|-19.39|0.49
71144581|NCT03583099|141782542|SUPERIORITY||Difference in proportion|10.8||||0.06|TWO_SIDED|95.0|-0.5|22.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||22.1|-0.5|0.06
71144582|NCT03583099|141782543|SUPERIORITY||Difference in proportion|0.41||||0.94|TWO_SIDED|95.0|-10.97|11.79|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||11.79|-10.97|0.94
71144583|NCT03583099|141782544|SUPERIORITY||Difference in proportion|2.7||||0.57|TWO_SIDED|95.0|-6.5|11.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||11.8|-6.5|0.57
70952637|NCT00316017|141406825|SUPERIORITY_OR_OTHER|||||||0.83||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died within 6 hours of admission to the hospital between the three groups among the patients who received 1-9 units of PRBC.||||0.83
70952638|NCT00316017|141406826|SUPERIORITY_OR_OTHER|||||||0.31||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died within 28 days from the time of the 911 call between the three groups among the patients who received 1-9 units of PRBC.||||0.31
71144584|NCT03583099|141782545|SUPERIORITY||Difference in proportion|1.36||||0.89|TWO_SIDED|95.0|-18.01|20.73|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||20.73|-18.01|0.89
71144585|NCT03583099|141782546|SUPERIORITY||Difference in proportion|-2.2||||0.65|TWO_SIDED|95.0|-12.1|7.6|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.6|-12.1|0.65
71144586|NCT03583099|141782547|SUPERIORITY||Difference in proportion|12.48||||0.16|TWO_SIDED|95.0|-5.0|29.96|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||29.96|-5.00|0.16
71144587|NCT03583099|141782548|SUPERIORITY||Difference in proportion|4.3||||0.29|TWO_SIDED|95.0|-3.6|12.2|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.2|-3.6|0.29
71144588|NCT03583099|141782549|SUPERIORITY||Difference in proportion|5.28||||0.44|TWO_SIDED|95.0|-8.07|18.62|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||18.62|-8.07|0.44
70952639|NCT00316017|141406827|SUPERIORITY_OR_OTHER|||||||0.97||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who received greater than 10 units of PRBC in first 24 hours between the three groups.||||0.97
71144589|NCT03583099|141782550|SUPERIORITY||Difference in proportion|-1.5||||0.62|TWO_SIDED|95.0|-7.6|4.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||4.5|-7.6|0.62
70952640|NCT00316017|141406829|SUPERIORITY_OR_OTHER|||||||0.35||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died within 6 hours of admission to the hospital between the three groups among the patients who received greater than 10 units of PRBC.||||0.35
70952641|NCT00316017|141406830|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died within 28 days from the time of the 911 call between the three groups among the patients who received greater than 10 units of PRBC.||||0.34
71144590|NCT03583099|141782551|SUPERIORITY||Difference in proportion|-7.1||||0.39|TWO_SIDED|95.0|-23.18|9.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||9.0|-23.18|0.39
71144591|NCT03583099|141782552|SUPERIORITY||Difference in proportion|-6.6||||0.08|TWO_SIDED|95.0|-13.9|0.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||0.8|-13.9|0.08
71144592|NCT03583099|141782553|SUPERIORITY||Difference in proportion|-11.3||||0.23|TWO_SIDED|95.0|-29.06|7.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.00|-29.06|0.23
70952642|NCT04531982|141406835|SUPERIORITY|||||||0.4825||||||Two-sided p-value for treatment difference at Week 26 from MMRM analysis.|Mixed Models Analysis|||Difference between LSM changes for adjunctive pimavanserin and adjunctive placebo (pimavanserin - placebo) at the specified visit from MMRM analysis.||||0.4825
70952643|NCT04531982|141406836|SUPERIORITY|||||||0.8872||||||Two-sided p-value for treatment difference at Week 26 from MMRM analysis.|Mixed Models Analysis|||||||0.8872
70952644|NCT04266795|141406841|SUPERIORITY||Hazard Ratio (HR)|0.99|||=|0.477|TWO_SIDED|95.0|0.61|1.6|||Log Rank|P-value was comparison of EFS between treatment groups and was based on the 1-sided stratified log-rank test statistic.|Hazard ratio was based on an unadjusted stratified Cox proportional hazard regression model with stratification factors (randomization strata of age and AML subtype) and treatment as a factor in the model.|||1.60|0.61|=0.477
70952645|NCT03570892|141406853|SUPERIORITY||Unadjusted stratified cox model hazard r|1.07|||=|0.694|TWO_SIDED|95.0|0.82|1.4|||Stratified log-rank test one-sided|||||1.40|0.82|= 0.694
70952646|NCT04854850|141406869|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70952647|NCT01123070|141406911|EQUIVALENCE|Bioequivalence declared if the back transformed 90% CI of geometric mean ratio is within the predefined limits of 0.75 to 1.33|Geometric mean ratio|0.93||||0.4265|TWO_SIDED|90.0|0.797|1.084|||ANCOVA|PK parameters were calculated using a logarithmic transformation. Covariates included body weight at screening, gender and treatment.|TL011 arm is the numerator and MabThera arm is the denominator|||1.084|0.797|0.4265
70952648|NCT01123070|141406912|EQUIVALENCE|Bioequivalence declared if the back transformed 90% CI of geometric mean ratio is within the predefined limits of 0.75 to 1.33|Geometric mean ratio|0.862||||0.0368|TWO_SIDED|90.0|0.768|0.968|||ANCOVA|PK parameters were calculated using a logarithmic transformation. Covariates included body weight at screening, gender and treatment.|TL011 arm is the numerator, MabThera arm is the denominator|||0.968|0.768|0.0368
71144593|NCT03583099|141782554|SUPERIORITY||Difference in means|-1.14||||0.97|TWO_SIDED|95.0|-6.42|4.13||The p-value adjusts for baseline CAT score.|Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||4.13|-6.42|0.97
71144594|NCT03583099|141782555|SUPERIORITY||Difference in means|-0.003||||0.47|TWO_SIDED|95.0|-1.86|1.85|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||1.85|-1.86|0.47
70952649|NCT01123070|141406914|EQUIVALENCE|Bioequivalence declared if the 90% CI of geometric mean ratio is within the predefined limits of 0.75 to 1.33|Geometric mean ratio|0.909||||0.1484|TWO_SIDED|90.0|0.814|1.014|||ANCOVA|PK parameters were calculated using a logarithmic transformation. Covariates included body weight at screening, gender and treatment.|TL011/MabThera|Cmax1||1.014|0.814|0.1484
70952650|NCT01123070|141406914|EQUIVALENCE|Bioequivalence declared if the 90% CI of geometric mean ratio is within the predefined limits of 0.75 to 1.33|Geometric mean ratio|0.766||||0.0241|TWO_SIDED|90.0|0.633|0.927|||ANCOVA|PK parameters were calculated using a logarithmic transformation. Covariates included body weight at screening, gender and treatment.|TL011/MabThera|Cmax2||0.927|0.633|0.0241
70952651|NCT01123070|141406915|EQUIVALENCE|Bioequivalence declared if the 90% CI of geometric mean ratio is within the predefined limits of 0.75 to 1.33|Geometric mean ratio|0.969||||0.652|TWO_SIDED|90.0|0.863|1.088|||ANCOVA|PK parameters were calculated using a logarithmic transformation. Covariates included body weight at screening, gender and treatment.|TL011 arm is the numerator, MabThera arm is the denominator|AUC1||1.088|0.863|0.6520
70952652|NCT01123070|141406915|EQUIVALENCE|Bioequivalence declared if the 90% CI of geometric mean ratio is within the predefined limits of 0.75 to 1.33|Geometric mean ratio|0.961||||0.7835|TWO_SIDED|90.0|0.757|1.222|||ANCOVA|PK parameters were calculated using a logarithmic transformation. Covariates included body weight at screening, gender and treatment.|TL011/MabThera|AUC2||1.222|0.757|0.7835
70952653|NCT00461981|141406955|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-60.6||||||95.0|-79.7|-31.7||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||-31.7|-79.7|
70952654|NCT00461981|141406956|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-60.9||||||95.0|-83.8|-26.0||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||-26.0|-83.8|
70952655|NCT00461981|141406957|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|44.2||||||95.0|12.0|67.8||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||67.8|12.0|
71144595|NCT03583099|141782556|SUPERIORITY||Difference in proportion|17.84||||0.02|TWO_SIDED|95.0|2.34|33.34|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||33.34|2.34|0.02
71144596|NCT03583099|141782557|SUPERIORITY||Difference in proportion|7.8||||0.12|TWO_SIDED|95.0|-2.0|17.6|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||17.6|-2.0|0.12
71144597|NCT03583099|141782558|SUPERIORITY|||||||1|||||||Fisher Exact|The p-value is calculated from a two-sided Fisher's exact test. This test is appropriate since only one outcome per practice was seen.||||||1.0
70952656|NCT00461981|141406958|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|16.2||||||95.0|-17.6|45.4||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||45.4|-17.6|
71144598|NCT03583099|141782559|SUPERIORITY||Difference in proportion|2.06||||0.87|TWO_SIDED|95.0|-22.67|26.79|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||26.79|-22.67|0.87
71144599|NCT03583099|141782560|SUPERIORITY|||||||1|||||||Fisher Exact|The p-value is calculated from a two-sided Fisher's exact test.||||||1.0
71144600|NCT03583099|141782561|SUPERIORITY||Difference in proportion|-5.53||||0.56|TWO_SIDED|95.0|-24.33|13.28|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.28|-24.33|0.56
71144601|NCT03583099|141782562|SUPERIORITY|||||||1|||||||Fisher Exact|The p-value is calculated from a two-sided Fisher's exact test.||||||1.0
71144602|NCT03583099|141782563|SUPERIORITY||Difference in proportion|12.66||||0.21|TWO_SIDED|95.0|-7.05|32.37|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||32.37|-7.05|0.21
71144603|NCT03583099|141782564|SUPERIORITY|||||||1|||||||Fisher Exact|The p-value is calculated from a two-sided Fisher's exact test.||||||1.0
71144604|NCT03583099|141782565|SUPERIORITY||Difference in proportion|-18.29||||0.08|TWO_SIDED|95.0|-38.66|2.08|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||2.08|-38.66|0.08
71144605|NCT03583099|141782566|SUPERIORITY|||||||1|||||||Fisher Exact|The p-value is calculated from a two-sided Fisher's exact test.||||||1.0
71144606|NCT03583099|141782567|SUPERIORITY||Difference in proportion|-0.67||||0.92|TWO_SIDED|95.0|-14.06|12.71|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.71|-14.06|0.92
71144607|NCT03583099|141782569|SUPERIORITY||Difference in proportion|-5.47||||0.29|TWO_SIDED|95.0|-15.72|4.77|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||4.77|-15.72|0.29
71144608|NCT03583099|141782571|SUPERIORITY||Difference in proportion|-2.87||||0.69|TWO_SIDED|95.0|-17.14|11.39|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||11.39|-17.14|0.69
71144609|NCT03583099|141782572|SUPERIORITY||Difference in proportion|-13.15||||0.32|TWO_SIDED|95.0|-39.06|12.76|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.76|-39.06|0.32
71144610|NCT03583099|141782573|SUPERIORITY||Difference in proportion|-0.2||||0.98|TWO_SIDED|95.0|-15.5|15.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||15.0|-15.5|0.98
71144611|NCT03583099|141782575|SUPERIORITY||Difference in proportion|3.1||||0.55|TWO_SIDED|95.0|-7.0|13.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.1|-7.0|0.55
71144612|NCT03583099|141782576|SUPERIORITY||Difference in proportion|-8.61||||0.43|TWO_SIDED|95.0|-30.19|12.97|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.97|-30.19|0.43
71144613|NCT03583099|141782577|SUPERIORITY||Difference in proportion|7.6||||0.1|TWO_SIDED|95.0|-1.4|16.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||16.5|-1.4|0.10
70952657|NCT00461981|141406959|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-18.2||||||95.0|-40.0|4.9||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||4.9|-40.0|
70952658|NCT00461981|141406960|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-5.6||||||95.0|-27.4|13.3||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||13.3|-27.4|
70952659|NCT00461981|141406961|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|35.7||||||95.0|9.5|57.1||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||57.1|9.5|
70952660|NCT00461981|141406962|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-5.0||||||95.0|-27.7|16.0||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||16.0|-27.7|
70952661|NCT00461981|141406963|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|14.7||||||95.0|-6.5|38.4||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||38.4|-6.5|
70952662|NCT00461981|141406964|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|38.1||||||95.0|0.9|65.9||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||65.9|0.9|
71144614|NCT03583099|141782578|SUPERIORITY||Difference in proportion|0.82||||0.94|TWO_SIDED|95.0|-20.92|21.92|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||21.92|-20.92|0.94
71144615|NCT03583099|141782579|SUPERIORITY||Difference in proportion|-3.4||||0.55|TWO_SIDED|95.0|-14.4|7.6|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.6|-14.4|0.55
71144616|NCT03583099|141782581|SUPERIORITY||Difference in proportion|-1.1||||0.8|TWO_SIDED|95.0|-9.3|7.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.1|-9.3|0.80
71144617|NCT03583099|141782583|SUPERIORITY||Difference in proportion|-3.9||||0.18|TWO_SIDED|95.0|-9.7|1.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||1.8|-9.7|0.18
71144618|NCT03583099|141782584|SUPERIORITY||Difference in proportion|-0.17||||0.99|TWO_SIDED|95.0|-26.06|25.72|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||25.72|-26.06|0.99
70952663|NCT00461981|141406965|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|11.7||||||95.0|-13.0|34.9||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||34.9|-13.0|
71144619|NCT03583099|141782585|SUPERIORITY||Difference in proportion|-2.6||||0.59|TWO_SIDED|95.0|-12.0|6.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.8|-12.0|0.59
71144620|NCT03583099|141782587|SUPERIORITY||Difference in proportion|1.9||||0.82|TWO_SIDED|95.0|-14.5|18.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||18.4|-14.5|0.82
71144621|NCT03583099|141782589|SUPERIORITY||Difference in proportion|7.6||||0.2|TWO_SIDED|95.0|-4.1|19.3|||Wilcoxon (Mann-Whitney)||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||19.3|-4.1|0.20
71144622|NCT03583099|141782591|SUPERIORITY||Difference in proportion|4.9||||0.36|TWO_SIDED|95.0|-5.5|15.3|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||15.3|-5.5|0.36
70869802|NCT04115839|141225237|SUPERIORITY||Difference in response rates|-2.8||||0.48|TWO_SIDED|95.0|-11.1|5.5||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||5.5|-11.1|0.48
70869803|NCT04115839|141225237|SUPERIORITY||Difference in response rates|2.5||||0.7|TWO_SIDED|95.0|-14.1|19.2||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||19.2|-14.1|0.70
70869804|NCT04115839|141225237|SUPERIORITY||Difference in response rates|-8.6||||0.17|TWO_SIDED|95.0|-20.7|3.6||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||3.6|-20.7|0.17
70869805|NCT04115839|141225237|SUPERIORITY||Difference in response rates|6.5||||0.34|TWO_SIDED|95.0|-12.5|25.6||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||25.6|-12.5|0.34
70869806|NCT04115839|141225237|SUPERIORITY||Difference in response rates|-0.3||||0.98|TWO_SIDED|95.0|-16.9|16.4||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||16.4|-16.9|0.98
70869807|NCT04115839|141225237|SUPERIORITY||Difference in response rates|18.7||||0.071|TWO_SIDED|95.0|-5.1|42.5||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||42.5|-5.1|0.071
70869808|NCT04115839|141225237|SUPERIORITY||Difference in response rates|-8.8||||0.27|TWO_SIDED|95.0|-27.7|10.1||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||10.1|-27.7|0.27
70869809|NCT04115839|141225237|SUPERIORITY||Difference in response rates|40.7||||0.002|TWO_SIDED|95.0|19.5|62.0||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||62.0|19.5|0.002
70869810|NCT04115839|141225237|SUPERIORITY||Difference in response rates|15.2||||0.082|TWO_SIDED|95.0|-2.3|32.6||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||32.6|-2.3|0.082
70952664|NCT00461981|141406966|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-15.8||||||95.0|-40.7|8.0||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||8.0|-40.7|
70869811|NCT04115839|141225239|SUPERIORITY||Difference in response rates|2.9|||||TWO_SIDED|95.0|-5.6|11.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||11.5|-5.6|
70869812|NCT04115839|141225239|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-2.9|2.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||2.9|-2.9|
70869813|NCT04115839|141225239|SUPERIORITY||Difference in response rates|2.8|||||TWO_SIDED|95.0|-5.4|11.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||11.0|-5.4|
70952665|NCT00461981|141406967|SUPERIORITY_OR_OTHER_LEGACY||GMT ratio|0.43||||||95.0|0.24|0.87||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||0.87|0.24|
70869814|NCT04115839|141225239|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-2.9|2.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||2.9|-2.9|
70869815|NCT04115839|141225239|SUPERIORITY||Difference in response rates|12.7|||||TWO_SIDED|95.0|-4.2|29.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||29.5|-4.2|
70869816|NCT04115839|141225239|SUPERIORITY||Difference in response rates|-2.9|||||TWO_SIDED|95.0|-11.6|5.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||5.7|-11.6|
70869817|NCT04115839|141225239|SUPERIORITY||Difference in response rates|18.3|||||TWO_SIDED|95.0|0.2|36.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||36.3|0.2|
70869818|NCT04115839|141225239|SUPERIORITY||Difference in response rates|2.9|||||TWO_SIDED|95.0|-9.7|15.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||15.6|-9.7|
70869819|NCT04115839|141225239|SUPERIORITY||Difference in response rates|12.5|||||TWO_SIDED|95.0|-2.0|27.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||27.0|-2.0|
70869820|NCT04115839|141225239|SUPERIORITY||Difference in response rates|9.1|||||TWO_SIDED|95.0|-3.7|21.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||21.9|-3.7|
70869821|NCT04115839|141225255|SUPERIORITY||Difference in response rates|9.5|||||TWO_SIDED|95.0|-10.4|29.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||29.4|-10.4|
70869822|NCT04115839|141225255|SUPERIORITY||Difference in response rates|7.1|||||TWO_SIDED|95.0|-12.5|26.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||26.7|-12.5|
70869823|NCT04115839|141225255|SUPERIORITY||Difference in response rates|20.0|||||TWO_SIDED|95.0|-3.8|43.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||43.8|-3.8|
70869824|NCT04115839|141225255|SUPERIORITY||Difference in response rates|6.5|||||TWO_SIDED|95.0|-16.3|29.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||29.3|-16.3|
70869825|NCT04115839|141225255|SUPERIORITY||Difference in response rates|17.8|||||TWO_SIDED|95.0|-8.8|44.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||44.5|-8.8|
70869826|NCT04115839|141225255|SUPERIORITY||Difference in response rates|2.9|||||TWO_SIDED|95.0|-22.9|28.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||28.8|-22.9|
71144623|NCT03583099|141782593|SUPERIORITY||Difference in proportion|4.6||||0.47|TWO_SIDED|95.0|-7.9|17.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||17.1|-7.9|0.47
70869827|NCT04115839|141225255|SUPERIORITY||Difference in response rates|25.0|||||TWO_SIDED|95.0|-0.5|50.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||50.6|-0.5|
70869828|NCT04115839|141225255|SUPERIORITY||Difference in response rates|14.7|||||TWO_SIDED|95.0|-10.5|39.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||39.9|-10.5|
70952666|NCT00461981|141406968|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.2||||||95.0|0.09|0.48||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||0.48|0.09|
70869829|NCT04115839|141225255|SUPERIORITY||Difference in response rates|18.5|||||TWO_SIDED|95.0|-8.7|45.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||45.6|-8.7|
71144624|NCT03583099|141782595|SUPERIORITY||Difference in proportion|0.6||||0.88|TWO_SIDED|95.0|-7.8|9.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||9.0|-7.8|0.88
70869830|NCT04115839|141225255|SUPERIORITY||Difference in response rates|6.1|||||TWO_SIDED|95.0|-20.5|32.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||32.6|-20.5|
70869831|NCT04115839|141225257|SUPERIORITY||Difference in response rates|9.0|||||TWO_SIDED|95.0|-6.0|23.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||23.9|-6.0|
70869832|NCT04115839|141225257|SUPERIORITY||Difference in response rates|3.3|||||TWO_SIDED|95.0|-9.4|15.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||15.9|-9.4|
70869833|NCT04115839|141225257|SUPERIORITY||Difference in response rates|5.7|||||TWO_SIDED|95.0|-14.7|26.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||26.2|-14.7|
70869834|NCT04115839|141225257|SUPERIORITY||Difference in response rates|-5.5|||||TWO_SIDED|95.0|-23.4|12.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||12.4|-23.4|
70869835|NCT04115839|141225257|SUPERIORITY||Difference in response rates|1.3|||||TWO_SIDED|95.0|-21.5|24.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||24.1|-21.5|
70869836|NCT04115839|141225257|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-22.2|22.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||22.2|-22.2|
70869837|NCT04115839|141225257|SUPERIORITY||Difference in response rates|21.6|||||TWO_SIDED|95.0|-0.8|43.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||43.9|-0.8|
70869838|NCT04115839|141225257|SUPERIORITY||Difference in response rates|20.6|||||TWO_SIDED|95.0|-1.4|42.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||42.6|-1.4|
70869839|NCT04115839|141225257|SUPERIORITY||Difference in response rates|17.5|||||TWO_SIDED|95.0|-7.7|42.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||42.7|-7.7|
70869840|NCT04115839|141225257|SUPERIORITY||Difference in response rates|3.0|||||TWO_SIDED|95.0|-20.2|26.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||26.3|-20.2|
70869841|NCT04115839|141225260|SUPERIORITY||Difference in response rates|9.3|||||TWO_SIDED|95.0|-9.2|27.8||||||Week 2||27.8|-9.2|
70869842|NCT04115839|141225260|SUPERIORITY||Difference in response rates|3.8|||||TWO_SIDED|95.0|-13.5|21.0||||||Week 2||21.0|-13.5|
70869843|NCT04115839|141225260|SUPERIORITY||Difference in response rates|5.7|||||TWO_SIDED|95.0|-16.8|28.2||||||Week 4||28.2|-16.8|
70869844|NCT04115839|141225260|SUPERIORITY||Difference in response rates|-2.4|||||TWO_SIDED|95.0|-23.7|19.0||||||Week 4||19.0|-23.7|
70869845|NCT04115839|141225260|SUPERIORITY||Difference in response rates|5.3|||||TWO_SIDED|95.0|-21.1|31.8||||||Week 8||31.8|-21.1|
70869846|NCT04115839|141225260|SUPERIORITY||Difference in response rates|-5.9|||||TWO_SIDED|95.0|-31.0|19.3||||||Week 8||19.3|-31.0|
70869847|NCT04115839|141225260|SUPERIORITY||Difference in response rates|19.2|||||TWO_SIDED|95.0|-7.0|45.3||||||Week 12||45.3|-7.0|
70869848|NCT04115839|141225260|SUPERIORITY||Difference in response rates|8.8|||||TWO_SIDED|95.0|-16.9|34.6||||||Week 12||34.6|-16.9|
70869849|NCT04115839|141225260|SUPERIORITY||Difference in response rates|18.5|||||TWO_SIDED|95.0|-8.7|45.6||||||Week 16||45.6|-8.7|
70869850|NCT04115839|141225260|SUPERIORITY||Difference in response rates|3.0|||||TWO_SIDED|95.0|-23.4|29.5||||||Week 16||29.5|-23.4|
70869851|NCT04115839|141225262|SUPERIORITY||Difference in response rates|-2.8|||||TWO_SIDED|95.0|-11.0|5.4||||||Week 2||5.4|-11.0|
70869852|NCT04115839|141225262|SUPERIORITY||Difference in response rates|0.3|||||TWO_SIDED|95.0|-10.6|11.1||||||Week 2||11.1|-10.6|
70869853|NCT04115839|141225262|SUPERIORITY||Difference in response rates|-2.9|||||TWO_SIDED|95.0|-15.2|9.5||||||Week 4||9.5|-15.2|
70869854|NCT04115839|141225262|SUPERIORITY||Difference in response rates|-5.7|||||TWO_SIDED|95.0|-16.3|4.9||||||Week 4||4.9|-16.3|
70869855|NCT04115839|141225262|SUPERIORITY||Difference in response rates|0.6|||||TWO_SIDED|95.0|-16.4|17.5||||||Week 8||17.5|-16.4|
70869856|NCT04115839|141225262|SUPERIORITY||Difference in response rates|-5.9|||||TWO_SIDED|95.0|-19.9|8.2||||||Week 8||8.2|-19.9|
70869857|NCT04115839|141225262|SUPERIORITY||Difference in response rates|12.2|||||TWO_SIDED|95.0|-4.3|28.7||||||Week 12||28.7|-4.3|
70869858|NCT04115839|141225262|SUPERIORITY||Difference in response rates|2.9|||||TWO_SIDED|95.0|-9.7|15.6||||||Week 12||15.6|-9.7|
70869859|NCT04115839|141225262|SUPERIORITY||Difference in response rates|13.1|||||TWO_SIDED|95.0|-4.2|30.4||||||Week 16||30.4|-4.2|
70869860|NCT04115839|141225262|SUPERIORITY||Difference in response rates|12.1|||||TWO_SIDED|95.0|-4.5|28.7||||||Week 16||28.7|-4.5|
70869861|NCT04115839|141225265|SUPERIORITY||Difference in response rates|18.5|||||TWO_SIDED|95.0|-3.8|40.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||40.7|-3.8|
70869862|NCT04115839|141225265|SUPERIORITY||Difference in response rates|7.3|||||TWO_SIDED|95.0|-13.5|28.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||28.2|-13.5|
70869863|NCT04115839|141225265|SUPERIORITY||Difference in response rates|16.0|||||TWO_SIDED|95.0|-8.5|40.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||40.4|-8.5|
70869864|NCT04115839|141225265|SUPERIORITY||Difference in response rates|15.5|||||TWO_SIDED|95.0|-9.4|40.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||40.3|-9.4|
70869865|NCT04115839|141225265|SUPERIORITY||Difference in response rates|18.8|||||TWO_SIDED|95.0|-7.5|45.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||45.0|-7.5|
70869866|NCT04115839|141225265|SUPERIORITY||Difference in response rates|-5.9|||||TWO_SIDED|95.0|-32.5|20.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||20.7|-32.5|
70869867|NCT04115839|141225265|SUPERIORITY||Difference in response rates|40.5|||||TWO_SIDED|95.0|15.8|65.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||65.2|15.8|
70869868|NCT04115839|141225265|SUPERIORITY||Difference in response rates|23.5|||||TWO_SIDED|95.0|-2.5|49.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||49.5|-2.5|
70869869|NCT04115839|141225265|SUPERIORITY||Difference in response rates|20.1|||||TWO_SIDED|95.0|-6.8|46.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||46.9|-6.8|
70869870|NCT04115839|141225265|SUPERIORITY||Difference in response rates|6.1|||||TWO_SIDED|95.0|-21.0|33.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||33.1|-21.0|
70869871|NCT04115839|141225269|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-31.0|31.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||31.0|-31.0|
70952667|NCT00461981|141406969|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|3.36||||||95.0|1.54|7.13||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||7.13|1.54|
71144625|NCT03583099|141782597|SUPERIORITY||Difference in proportion|-4.3||||0.27|TWO_SIDED|95.0|-12.0|3.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||3.4|-12.0|0.27
71144626|NCT03583099|141782598|SUPERIORITY||Difference in proportion|-4.94||||0.82|TWO_SIDED|95.0|-47.92|38.04|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||38.04|-47.92|0.82
71144627|NCT03583099|141782599|SUPERIORITY||Difference in proportion|-1.1||||0.87|TWO_SIDED|95.0|-14.5|12.2|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.2|-14.5|0.87
71144628|NCT03583099|141782600|SUPERIORITY||Difference in proportion|-37.6||||0.03|TWO_SIDED|95.0|-71.8|-3.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||-3.5|-71.8|0.03
71144629|NCT03583099|141782601|SUPERIORITY||Difference in proportion|2.3||||0.56|TWO_SIDED|95.0|-5.6|10.3|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||10.3|-5.6|0.56
71144630|NCT03583099|141782602|SUPERIORITY||Difference in proportion|-23.07||||0.06|TWO_SIDED|95.0|-47.4|1.27|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||1.27|-47.40|0.06
71144631|NCT03583099|141782603|SUPERIORITY||Difference in proportion|3.2||||0.39|TWO_SIDED|95.0|-4.0|10.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||10.4|-4.0|0.39
71144632|NCT03583099|141782604|SUPERIORITY||Difference in proportion|-1.72||||0.84|TWO_SIDED|95.0|-18.24|14.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||14.80|-18.24|0.84
71144633|NCT03583099|141782605|SUPERIORITY||Difference in proportion|2.0||||0.42|TWO_SIDED|95.0|-2.9|6.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.9|-2.9|0.42
71144634|NCT03583099|141782606|SUPERIORITY||Difference in proportion|-42.09||||0.01|TWO_SIDED|95.0|-74.27|-9.92|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||-9.92|-74.27|0.01
71144635|NCT03583099|141782607|SUPERIORITY||Difference in proportion|2.4||||0.47|TWO_SIDED|95.0|-4.2|9.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||9.1|-4.2|0.47
71144636|NCT03583099|141782608|SUPERIORITY||Difference in proportion|-12.27||||0.34|TWO_SIDED|95.0|-37.72|13.18|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.18|-37.72|0.34
71144637|NCT03583099|141782609|SUPERIORITY||Difference in proportion|2.4||||0.39|TWO_SIDED|95.0|-3.1|7.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.9|-3.1|0.39
71144638|NCT03583099|141782611|SUPERIORITY||Difference in proportion|-1.2||||0.59|TWO_SIDED|95.0|-5.5|3.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||3.1|-5.5|0.59
71144639|NCT03583099|141782613|SUPERIORITY||Difference in proportion|0.3||||0.94|TWO_SIDED|95.0|-8.2|8.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||8.8|-8.2|0.94
71144640|NCT03583099|141782614|SUPERIORITY||Difference in proportion|0.6||||0.93|TWO_SIDED|95.0|-12.2|13.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.4|-12.2|0.93
71144641|NCT03583099|141782615|SUPERIORITY||Difference in proportion|-8.2||||0.25|TWO_SIDED|95.0|-22.0|5.7|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||5.7|-22.0|0.25
71144642|NCT03583099|141782616|SUPERIORITY||Difference in proportion|-3.4||||0.48|TWO_SIDED|95.0|-12.7|6.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.0|-12.7|0.48
70952668|NCT00461981|141406970|SUPERIORITY_OR_OTHER_LEGACY||GMT ratio|3.26||||||95.0|1.44|7.19||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||7.19|1.44|
70952669|NCT00461981|141406971|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|1.06||||||95.0|0.56|1.96||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.96|0.56|
70952670|NCT00461981|141406972|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.58||||||95.0|0.31|1.12||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.12|0.31|
71144643|NCT03583099|141782617|SUPERIORITY||Difference in proportion|3.9||||0.45|TWO_SIDED|95.0|-6.3|14.2|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||14.2|-6.3|0.45
71144644|NCT03583099|141782619|SUPERIORITY||Difference in proportion|-2.2||||0.48|TWO_SIDED|95.0|-8.4|3.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||3.9|-8.4|0.48
71144645|NCT03583099|141782620|SUPERIORITY||Difference in proportion|-0.4||||0.97|TWO_SIDED|95.0|-20.4|19.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||19.5|-20.4|0.97
71144646|NCT03583099|141782621|SUPERIORITY||Difference in proportion|-12.1||||0.04|TWO_SIDED|95.0|-23.5|-0.6|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||-0.6|-23.5|0.04
71144647|NCT03583099|141782622|SUPERIORITY||Difference in proportion|-1.8||||0.39|TWO_SIDED|95.0|-5.8|2.3|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||2.3|-5.8|0.39
71144648|NCT03583099|141782623|SUPERIORITY||Difference in proportion|-7.3||||0.06|TWO_SIDED|95.0|-14.9|0.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||0.4|-14.9|0.06
71144649|NCT03583099|141782624|SUPERIORITY||Difference in proportion|-0.9||||0.82|TWO_SIDED|95.0|-8.8|7.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.0|-8.8|0.82
70869872|NCT04115839|141225269|SUPERIORITY||Difference in response rates|22.0|||||TWO_SIDED|95.0|-12.8|56.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||56.7|-12.8|
70869873|NCT04115839|141225269|SUPERIORITY||Difference in response rates|4.3|||||TWO_SIDED|95.0|-37.9|46.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||46.5|-37.9|
70869874|NCT04115839|141225269|SUPERIORITY||Difference in response rates|5.5|||||TWO_SIDED|95.0|-35.4|46.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||46.3|-35.4|
70869875|NCT04115839|141225269|SUPERIORITY||Difference in response rates|17.1|||||TWO_SIDED|95.0|-25.6|59.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||59.9|-25.6|
70869876|NCT04115839|141225269|SUPERIORITY||Difference in response rates|-13.4|||||TWO_SIDED|95.0|-53.7|26.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||26.8|-53.7|
70869877|NCT04115839|141225269|SUPERIORITY||Difference in response rates|28.6|||||TWO_SIDED|95.0|-14.1|71.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||71.2|-14.1|
70869878|NCT04115839|141225269|SUPERIORITY||Difference in response rates|-0.4|||||TWO_SIDED|95.0|-40.8|39.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||39.9|-40.8|
70869879|NCT04115839|141225271|SUPERIORITY||Difference in response rates|6.7||||0.55|TWO_SIDED|95.0|-21.3|34.7||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||34.7|-21.3|0.55
70869880|NCT04115839|141225271|SUPERIORITY||Difference in response rates|11.0||||0.24|TWO_SIDED|95.0|-17.4|39.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||39.3|-17.4|0.24
70869881|NCT04115839|141225271|SUPERIORITY||Difference in response rates|6.2||||0.47|TWO_SIDED|95.0|-22.6|35.0||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||35.0|-22.6|0.47
70869882|NCT04115839|141225271|SUPERIORITY||Difference in response rates|10.5||||0.25|TWO_SIDED|95.0|-18.6|39.6||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||39.6|-18.6|0.25
70869883|NCT04115839|141225271|SUPERIORITY||Difference in response rates|18.6||||0.44|TWO_SIDED|95.0|-21.1|58.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||58.3|-21.1|0.44
70869884|NCT04115839|141225271|SUPERIORITY||Difference in response rates|-3.8||||0.68|TWO_SIDED|95.0|-38.4|30.8||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||30.8|-38.4|0.68
70869885|NCT04115839|141225271|SUPERIORITY||Difference in response rates|21.4||||0.33|TWO_SIDED|95.0|-19.4|62.2||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||62.2|-19.4|0.33
70952671|NCT00461981|141406973|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|2.4||||||95.0|1.48|3.97||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||3.97|1.48|
70869886|NCT04115839|141225271|SUPERIORITY||Difference in response rates|2.1||||0.98|TWO_SIDED|95.0|-33.9|38.1||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||38.1|-33.9|0.98
70869887|NCT04115839|141225273|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-24.5|24.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||24.5|-24.5|
70869888|NCT04115839|141225273|SUPERIORITY||Difference in response rates|-0.8|||||TWO_SIDED|95.0|-23.9|22.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||22.4|-23.9|
70869889|NCT04115839|141225273|SUPERIORITY||Difference in response rates|13.3|||||TWO_SIDED|95.0|-10.8|37.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||37.4|-10.8|
70869890|NCT04115839|141225273|SUPERIORITY||Difference in response rates|5.9|||||TWO_SIDED|95.0|-11.8|23.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||23.6|-11.8|
70869891|NCT04115839|141225273|SUPERIORITY||Difference in response rates|-14.8|||||TWO_SIDED|95.0|-46.6|17.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||17.1|-46.6|
70869892|NCT04115839|141225273|SUPERIORITY||Difference in response rates|-15.5|||||TWO_SIDED|95.0|-46.3|15.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||15.2|-46.3|
70952672|NCT00461981|141406974|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.48||||||95.0|0.27|0.87||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||0.87|0.27|
70952673|NCT00461981|141406975|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|1.45||||||95.0|0.8|2.66||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||2.66|0.80|
71144650|NCT03583099|141782625|SUPERIORITY||Difference in proportion|0.6||||0.86|TWO_SIDED|95.0|-6.6|7.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.9|-6.6|0.86
71144651|NCT03583099|141782626|SUPERIORITY||Difference in proportion|-7.4||||0.14|TWO_SIDED|95.0|-17.3|2.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||2.5|-17.3|0.14
71144652|NCT03583099|141782628|SUPERIORITY||Difference in proportion|-14.66||||0.21|TWO_SIDED|95.0|-37.54|8.22|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||8.22|-37.54|0.21
71144653|NCT03583099|141782629|SUPERIORITY||Difference in proportion|0.4||||0.76|TWO_SIDED|95.0|-2.0|2.7|||Generalized estimating equation contrast|||||2.7|-2.0|0.76
71144654|NCT03583099|141782632|SUPERIORITY||Difference in proportion|0.6||||0.66|TWO_SIDED|95.0|-2.1|3.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||3.4|-2.1|0.66
71144655|NCT03631940|141782664|SUPERIORITY||Least squares mean difference|-0.49||||0.87|TWO_SIDED|95.0|-6.36|5.37|||Hierarchical generalized linear mixed mo|Hierarchical generalized linear mixed models||||5.37|-6.36|.87
71144656|NCT00836589|141782677|NON_INFERIORITY|"Estimated SAEFR at 5 years is 92.5% with a 5% non-inferiority margin (87.5%).~Type I error (alpha) is 0.05 (one-sided for non-inferiority).~Statistical power is 80%."||||||0.002|||||||Binomial Proportion|||||||0.0020
71144657|NCT01890343|141782698|SUPERIORITY_OR_OTHER|||||||0.002|||||||Kruskal-Wallis|||The effect of diagnostic group on mean cortical florbetapir binding relative to cerebellar cortex was determined.||||0.002
70869893|NCT04115839|141225273|SUPERIORITY||Difference in response rates|21.4|||||TWO_SIDED|95.0|-13.0|55.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||55.8|-13.0|
71144658|NCT00772538|141782723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.034||0.011||95.0|0.02|0.152||Step-wise testing for co-primary endpoints, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.152|0.020|0.0110
71144659|NCT00772538|141782724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.031||0.005||95.0|0.027|0.149||Step-wise testing for co-primary endpoints, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.149|0.027|0.0050
71144660|NCT00772538|141782725|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0343||||||Confirmatory only if previous hypotheses for each of the 2 twin studies had been successful, significance level of alpha=0.05 (2-sided). A pre-specified interim analysis was performed. Cui et al (Biometrics,1999) was used to calculate the p-value.|Regression, Cox|Parameter estimates of Cox proportional hazard model regression regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|||||0.0343
71144661|NCT00772538|141782726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.043||0.0362||95.0|0.006|0.173||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.173|0.006|0.0362
71144662|NCT00772538|141782727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.04||0.0007||95.0|0.058|0.214||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.214|0.058|0.0007
71144663|NCT00772538|141782728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.032||0.0067||95.0|0.024|0.149||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.149|0.024|0.0067
71144664|NCT00772538|141782729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.04||0.0139||95.0|0.02|0.176||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.176|0.020|0.0139
71144665|NCT00772538|141782730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.034||0.0347||95.0|0.005|0.14||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.140|0.005|0.0347
70869894|NCT04115839|141225273|SUPERIORITY||Difference in response rates|4.6|||||TWO_SIDED|95.0|-22.3|31.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||31.5|-22.3|
70952674|NCT00461981|141406976|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|1.75||||||95.0|0.88|3.39||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||3.39|0.88|
70952675|NCT00461981|141406977|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|1.49||||||95.0|0.8|2.69||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||2.69|0.80|
70952676|NCT00461981|141406978|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.62||||||95.0|0.33|1.16||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.16|0.33|
70952677|NCT00461981|141406979|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-45.9||||||95.0|-71.7|-11.6||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||-11.6|-71.7|
70952678|NCT00461981|141406980|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-25.0||||||95.0|-57.2|4.8||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||4.8|-57.2|
70952679|NCT00461981|141406981|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|65.0||||||95.0|34.4|85.3||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||85.3|34.4|
70952680|NCT00461981|141406982|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-0.6||||||95.0|-30.4|30.3||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||30.3|-30.4|
70952681|NCT00461981|141406983|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-37.0||||||95.0|-57.8|-17.5||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||-17.5|-57.8|
70952682|NCT00461981|141406984|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-8.3||||||95.0|-38.5|14.5||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||14.5|-38.5|
70952683|NCT00461981|141406985|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|21.9||||||95.0|-6.7|48.1||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||48.1|-6.7|
70869895|NCT04115839|141225275|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-6.7|6.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||6.7|-6.7|
70952684|NCT00461981|141406986|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-22.4||||||95.0|-54.4|12.2||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||12.2|-54.4|
70952685|NCT00461981|141406987|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|33.3||||||95.0|-81.1|90.6||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||90.6|-81.1|
70952686|NCT00461981|141406988|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|0.0||||||95.0|-97.5|84.2||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||84.2|-97.5|
71144666|NCT00772538|141782731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.032||0.1896||95.0|-0.021|0.104||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.104|-0.021|0.1896
70869896|NCT04115839|141225275|SUPERIORITY||Difference in response rates|5.9|||||TWO_SIDED|95.0|-11.6|23.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||23.3|-11.6|
71144667|NCT00772538|141782732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.032||0.0247||95.0|0.009|0.136||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.136|0.009|0.0247
71144668|NCT00772538|141782733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.043||0.0039||95.0|0.04|0.21||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.210|0.040|0.0039
71144669|NCT00772538|141782734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.04||0.0063||95.0|0.031|0.19||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.190|0.031|0.0063
71144670|NCT00772538|141782735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.122|STANDARD_ERROR_OF_MEAN|0.041||0.0027||95.0|0.042|0.201||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.201|0.042|0.0027
71144671|NCT00772538|141782736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.293|STANDARD_ERROR_OF_MEAN|4.584|<|0.0001||95.0|13.279|31.308||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||31.308|13.279|<0.0001
70952687|NCT00461981|141406989|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-9.5||||||95.0|-65.2|58.8||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||58.8|-65.2|
71144672|NCT00772538|141782737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.267|STANDARD_ERROR_OF_MEAN|4.699|<|0.0001||95.0|14.027|32.507||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||32.507|14.027|<0.0001
71144673|NCT00772538|141782738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.061|0.173||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.173|0.061|<0.0001
71144674|NCT00772538|141782739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.124|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.068|0.181||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.181|0.068|<0.0001
70869897|NCT04115839|141225275|SUPERIORITY||Difference in response rates|6.7|||||TWO_SIDED|95.0|-12.9|26.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||26.2|-12.9|
71144675|NCT00772538|141782740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.283|STANDARD_ERROR_OF_MEAN|0.736||0.7012||95.0|-1.165|1.731||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||1.731|-1.165|0.7012
70869898|NCT04115839|141225275|SUPERIORITY||Difference in response rates|5.9|||||TWO_SIDED|95.0|-11.8|23.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||23.6|-11.8|
71144676|NCT00772538|141782741|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.0499||95.0|0.49|1.0||Significance level of alpha=0.05 (two-sided).|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|||1.00|0.49|0.0499
70952688|NCT00461981|141406990|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-20.0||||||95.0|-71.6|33.9||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||33.9|-71.6|
70952689|NCT00461981|141406991|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.23||||||95.0|0.15|0.35||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||0.35|0.15|
71144677|NCT00772538|141782742|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.71|STANDARD_ERROR_OF_MEAN|0.09||0.0102||95.0|0.55|0.92||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo|||0.92|0.55|0.0102
71144678|NCT00772538|141782743|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.64|STANDARD_ERROR_OF_MEAN|0.1||0.0062||95.0|0.46|0.88||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo|||0.88|0.46|0.0062
71144679|NCT00772538|141782744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.0065||95.0|0.4|0.88||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo|||0.88|0.40|0.0065
71144680|NCT00772538|141782745|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.0561||95.0|0.42|1.01||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo|||1.01|0.42|0.0561
71144681|NCT00772538|141782746|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.5604||95.0|0.3|1.92||Significance level of alpha=0.05 (two-sided).|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium|||1.92|0.30|0.5604
71144682|NCT00772538|141782747|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.87|STANDARD_ERROR_OF_MEAN|0.21||0.5538||95.0|0.54|1.39||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo|||1.39|0.54|0.5538
71144683|NCT00772538|141782748|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.633||95.0|0.25|2.13||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo|||2.13|0.25|0.6330
71144684|NCT00772538|141782749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.074||0.5714||95.0|-0.103|0.186||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.186|-0.103|0.5714
71144685|NCT00772538|141782750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038|STANDARD_ERROR_OF_MEAN|0.075||0.6099||95.0|-0.109|0.185||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.185|-0.109|0.6099
71144686|NCT00772538|141782751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.126|STANDARD_ERROR_OF_MEAN|0.066||0.0586||95.0|-0.256|0.005||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.005|-0.256|0.0586
71144687|NCT00772538|141782752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.121|STANDARD_ERROR_OF_MEAN|0.067||0.0727||95.0|-0.253|0.011||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.011|-0.253|0.0727
71144688|NCT00772538|141782753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.024||0.9807||95.0|-0.048|0.047||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.047|-0.048|0.9807
71144689|NCT00772538|141782754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.092|STANDARD_ERROR_OF_MEAN|0.172||0.5927||95.0|-0.43|0.246||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.246|-0.430|0.5927
71144690|NCT00772538|141782755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.0427|TWO_SIDED|95.0|1.01|1.73||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|Comparison at 24 weeks||1.73|1.01|0.0427
71144691|NCT00772538|141782755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.0001|TWO_SIDED|95.0|1.28|2.21||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|Comparison at 48 weeks||2.21|1.28|0.0001
71144692|NCT00189540|141782756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||95.0|||||ANCOVA|||Comparison made is the difference from baseline at Month 3.||||0.35
71144693|NCT00189540|141782756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||95.0|||||ANCOVA|||Comparison made is the difference from baseline at Month 6.||||0.17
71144694|NCT00189540|141782757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0|||||Fisher Exact|||The comparison of groups at Month 3||||0.55
70869899|NCT04115839|141225275|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-6.9|6.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||6.9|-6.9|
71144695|NCT00189540|141782757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28||95.0|||||Fisher Exact|||The comparison of groups at Month 6.||||0.28
71144696|NCT00189540|141782758|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||95.0|||||ANCOVA|||Comparison between groups at Month 3||||0.2
71144697|NCT00189540|141782758|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04||95.0|||||ANCOVA|||Comparison between groups at Month 6||||0.04
71144698|NCT00189540|141782759|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Fisher Exact|||||||1.00
71144699|NCT00189540|141782760|SUPERIORITY_OR_OTHER_LEGACY|||||||0.77||95.0|||||ANCOVA|||Comparison at Month 3||||0.77
71144700|NCT00189540|141782760|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45||95.0|||||ANCOVA|||Comparison at Month 6||||0.45
71144701|NCT00189540|141782761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06||95.0|||||ANCOVA|||Comparison between groups for mean TBI at Month 3 versus baseline.||||0.06
71144702|NCT00189540|141782761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0|||||ANCOVA|||Comparison between groups for mean TBI at Month 6 versus baseline.||||0.05
71144703|NCT00713609|141782762|SUPERIORITY_OR_OTHER|||||||0.692||||||For ILC|ANCOVA|||||||0.692
71144704|NCT00713609|141782762|SUPERIORITY_OR_OTHER|||||||0.467||||||For ILC|ANCOVA|||||||0.467
71144705|NCT00713609|141782762|SUPERIORITY_OR_OTHER|||||||0.281||||||For ILC|ANCOVA|||||||0.281
71144706|NCT00713609|141782762|SUPERIORITY_OR_OTHER|||||||0.075||||||For ILC|ANCOVA|||||||0.075
71144707|NCT00713609|141782762|SUPERIORITY_OR_OTHER||||||<|0.001||||||For ILC|ANCOVA|||||||<0.001
71144708|NCT00713609|141782762|SUPERIORITY_OR_OTHER||||||<|0.001||||||For NILC|ANCOVA|||||||<0.001
71144709|NCT00713609|141782762|SUPERIORITY_OR_OTHER|||||||0.803||||||For NILC|ANCOVA|||||||0.803
71144710|NCT00713609|141782762|SUPERIORITY_OR_OTHER|||||||0.175||||||For NILC|ANCOVA|||||||0.175
71144711|NCT00713609|141782762|SUPERIORITY_OR_OTHER|||||||0.552||||||For NILC|ANCOVA|||||||0.552
71144712|NCT00713609|141782762|SUPERIORITY_OR_OTHER||||||<|0.001||||||For NILC|ANCOVA|||||||<0.001
71144713|NCT00713609|141782762|SUPERIORITY_OR_OTHER|||||||0.006||||||For TC|ANCOVA|||||||0.006
71144714|NCT00713609|141782762|SUPERIORITY_OR_OTHER|||||||0.618||||||For TC|ANCOVA|||||||0.618
71144715|NCT00713609|141782762|SUPERIORITY_OR_OTHER|||||||0.149||||||For TC|ANCOVA|||||||0.149
71144716|NCT00713609|141782762|SUPERIORITY_OR_OTHER|||||||0.255||||||For TC|ANCOVA|||||||0.255
71144717|NCT00713609|141782762|SUPERIORITY_OR_OTHER||||||<|0.001||||||For TC|ANCOVA|||||||<0.001
71144718|NCT00713609|141782763|SUPERIORITY_OR_OTHER|||||||0.922|||||||Cochran-Mantel-Haenszel|||||||0.922
71144719|NCT00713609|141782763|SUPERIORITY_OR_OTHER|||||||0.132|||||||Cochran-Mantel-Haenszel|||||||0.132
71144720|NCT00713609|141782763|SUPERIORITY_OR_OTHER|||||||0.02|||||||Cochran-Mantel-Haenszel|||||||0.020
71144721|NCT00713609|141782763|SUPERIORITY_OR_OTHER|||||||0.706|||||||Cochran-Mantel-Haenszel|||||||0.706
71144722|NCT00713609|141782763|SUPERIORITY_OR_OTHER|||||||0.009|||||||Cochran-Mantel-Haenszel|||||||0.009
71144723|NCT00713609|141782764|SUPERIORITY_OR_OTHER|||||||0.504||||||For ILC|ANCOVA|||||||0.504
71144724|NCT00713609|141782764|SUPERIORITY_OR_OTHER|||||||0.504||||||For ILC|ANCOVA|||||||0.504
71144725|NCT00713609|141782764|SUPERIORITY_OR_OTHER|||||||0.177||||||For ILC|ANCOVA|||||||0.177
71144726|NCT00713609|141782764|SUPERIORITY_OR_OTHER|||||||0.084||||||For ILC|ANCOVA|||||||0.084
71144727|NCT00713609|141782764|SUPERIORITY_OR_OTHER||||||<|0.001||||||For ILC|ANCOVA|||||||<0.001
71144728|NCT00713609|141782764|SUPERIORITY_OR_OTHER||||||<|0.001||||||For NILC|ANCOVA|||||||<0.001
71144729|NCT00713609|141782764|SUPERIORITY_OR_OTHER|||||||0.776||||||For NILC|ANCOVA|||||||0.776
71144730|NCT00713609|141782764|SUPERIORITY_OR_OTHER|||||||0.465||||||For NILC|ANCOVA|||||||0.465
71144731|NCT00713609|141782764|SUPERIORITY_OR_OTHER|||||||0.288||||||For NILC|ANCOVA|||||||0.288
71144732|NCT00713609|141782764|SUPERIORITY_OR_OTHER||||||<|0.001||||||For NILC|ANCOVA|||||||<0.001
71144733|NCT00713609|141782764|SUPERIORITY_OR_OTHER|||||||0.006||||||For TC|ANCOVA|||||||0.006
71144734|NCT00713609|141782764|SUPERIORITY_OR_OTHER|||||||0.62||||||For TC|ANCOVA|||||||0.620
71144735|NCT00713609|141782764|SUPERIORITY_OR_OTHER|||||||0.291||||||For TC|ANCOVA|||||||0.291
71144736|NCT00713609|141782764|SUPERIORITY_OR_OTHER|||||||0.085||||||For TC|ANCOVA|||||||0.085
71144737|NCT00713609|141782764|SUPERIORITY_OR_OTHER||||||<|0.001||||||For TC|ANCOVA|||||||<0.001
71144738|NCT00713609|141782765|SUPERIORITY_OR_OTHER|||||||0.652|||||||Cochran-Mantel-Haenszel|||||||0.652
71144739|NCT00713609|141782765|SUPERIORITY_OR_OTHER|||||||0.279|||||||Cochran-Mantel-Haenszel|||||||0.279
71144740|NCT00713609|141782765|SUPERIORITY_OR_OTHER|||||||0.312|||||||Cochran-Mantel-Haenszel|||||||0.312
71144741|NCT00713609|141782765|SUPERIORITY_OR_OTHER|||||||0.063|||||||Cochran-Mantel-Haenszel|||||||0.063
71144742|NCT00713609|141782765|SUPERIORITY_OR_OTHER|||||||0.005|||||||Cochran-Mantel-Haenszel|||||||0.005
71144743|NCT01903356|141782766|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis.||Comparison of % of HbA1c before and 24 weeks after administration of TrajentaDuo® Tablet treatment.|The difference considered in the analysis is HbA1c values after drug administration minus HbA1c values before drug administration|||<0.0001
70869900|NCT04115839|141225275|SUPERIORITY||Difference in response rates|5.9|||||TWO_SIDED|95.0|-11.8|23.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||23.6|-11.8|
70869901|NCT04115839|141225275|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-7.1|7.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||7.1|-7.1|
70869902|NCT04115839|141225275|SUPERIORITY||Difference in response rates|5.9|||||TWO_SIDED|95.0|-11.8|23.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||23.6|-11.8|
70869903|NCT04115839|141225283|SUPERIORITY||LS Mean Treatment Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.066||0.19|TWO_SIDED|95.0|-0.22|0.04||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 2||0.04|-0.22|0.19
70869904|NCT04115839|141225283|SUPERIORITY||LS Mean Treatment Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.067||0.84|TWO_SIDED|95.0|-0.15|0.12||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 2||0.12|-0.15|0.84
70869905|NCT04115839|141225283|SUPERIORITY||LS Mean Treatment Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.073||0.3|TWO_SIDED|95.0|-0.22|0.07||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||0.07|-0.22|0.30
70869906|NCT04115839|141225283|SUPERIORITY||LS Mean Treatment Difference|0.01|STANDARD_ERROR_OF_MEAN|0.074||0.89|TWO_SIDED|95.0|-0.14|0.16||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||0.16|-0.14|0.89
70869907|NCT04115839|141225283|SUPERIORITY||LS Mean Treatment Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.096||0.064|TWO_SIDED|95.0|-0.37|0.01||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 8||0.01|-0.37|0.064
70869908|NCT04115839|141225283|SUPERIORITY||LS Mean Treatment Difference|0.01|STANDARD_ERROR_OF_MEAN|0.096||0.88|TWO_SIDED|95.0|-0.17|0.2||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 8||0.20|-0.17|0.88
70869909|NCT04115839|141225283|SUPERIORITY||LS Mean Treatment Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.099||0.023|TWO_SIDED|95.0|-0.43|-0.03||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 12||-0.03|-0.43|0.023
70869910|NCT04115839|141225283|SUPERIORITY||LS Mean Treatment Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.099||0.75|TWO_SIDED|95.0|-0.23|0.17||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 12||0.17|-0.23|0.75
70869911|NCT04115839|141225283|SUPERIORITY||LS Mean Treatment Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.106||0.005|TWO_SIDED|95.0|-0.51|-0.1||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||-0.10|-0.51|0.005
70952690|NCT00461981|141406992|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.11||||||95.0|0.05|0.22||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||0.22|0.05|
70869912|NCT04115839|141225283|SUPERIORITY||LS Mean Treatment Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.105||0.54|TWO_SIDED|95.0|-0.27|0.14||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||0.14|-0.27|0.54
70869913|NCT04115839|141225285|SUPERIORITY||LS Mean Treatment Difference|1.3|STANDARD_ERROR_OF_MEAN|1.64||0.43|TWO_SIDED|95.0|-1.9|4.5||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||4.5|-1.9|0.43
70869914|NCT04115839|141225285|SUPERIORITY||LS Mean Treatment Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.64||0.81|TWO_SIDED|95.0|-3.6|2.9||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||2.9|-3.6|0.81
70869915|NCT04115839|141225285|SUPERIORITY||LS Mean Treatment Difference|5.1|STANDARD_ERROR_OF_MEAN|2.43||0.04|TWO_SIDED|95.0|0.2|9.9||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||9.9|0.2|0.040
70869916|NCT04115839|141225285|SUPERIORITY||LS Mean Treatment Difference|1.4|STANDARD_ERROR_OF_MEAN|2.41||0.58|TWO_SIDED|95.0|-3.4|6.1||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||6.1|-3.4|0.58
70869917|NCT04115839|141225289|SUPERIORITY||LS Mean Treatment Difference|0.9|STANDARD_ERROR_OF_MEAN|1.09||0.4|TWO_SIDED|95.0|-1.2|3.1||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||3.1|-1.2|0.40
70869918|NCT04115839|141225289|SUPERIORITY||LS Mean Treatment Difference|1.2|STANDARD_ERROR_OF_MEAN|1.1||0.28|TWO_SIDED|95.0|-1.0|3.4||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||3.4|-1.0|0.28
70869919|NCT04115839|141225289|SUPERIORITY||LS Mean Treatment Difference|3.8|STANDARD_ERROR_OF_MEAN|1.46||0.011|TWO_SIDED|95.0|0.9|6.7||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||6.7|0.9|0.011
71144744|NCT01903356|141782769|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis.||Comparison of FPG before and 24 weeks after administration of TrajentaDuo® Tablet treatment|The difference considered in the analysis is FPG values after drug administration minus FPG values before drug administration|||<0.0001
70952691|NCT00461981|141406993|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|4.85||||||95.0|2.51|9.22||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||9.22|2.51|
71144745|NCT04529083|141782771|OTHER||Mean Difference (Net)|-0.625||||0.011|TWO_SIDED|95.0|-1.06|-0.19|||t-test, 2 sided|||||-0.19|-1.06|0.011
71144746|NCT04529083|141782773|SUPERIORITY||Mean Difference (Net)|1.94||||0.006|TWO_SIDED|95.0|0.63|3.26|||t-test, 2 sided|||||3.26|0.63|0.006
71144747|NCT03305666|141782774|NON_INFERIORITY|Statistical analyses were conduced using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.12|||||||ANOVA|||||||0.12
71144748|NCT03305666|141782775|NON_INFERIORITY|Statistical analyses were conducted using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.41|||||||ANOVA|||This is the P-Value for between groups comparison of Postoperative Day #1.||||0.41
71144749|NCT03305666|141782775|NON_INFERIORITY|Statistical analyses were conducted using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.25|||||||ANOVA|||This is the P-Value for between groups comparison of Postoperative Day #2.||||0.25
71144750|NCT03305666|141782775|NON_INFERIORITY|Statistical analyses were conducted using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.12|||||||ANOVA|||This is the P-Value for between groups comparison of Postoperative Day #3.||||0.12
71144751|NCT03305666|141782775|NON_INFERIORITY|Statistical analyses were conducted using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.04|||||||ANOVA|||This is the P-Value for between groups comparison of Postoperative Day #4.||||0.04
71144752|NCT03305666|141782775|NON_INFERIORITY|Statistical analyses were conducted using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.32|||||||ANOVA|||This is the P-Value for between groups comparison of Postoperative Day #5.||||0.32
71144753|NCT03305666|141782776|NON_INFERIORITY|Statistical analyses were conduced using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.23|||||||ANOVA|||||||0.23
71144754|NCT04196686|141782780|OTHER||Hazard Ratio (HR)|0.36|||<|0.001|TWO_SIDED|95.0|0.25|0.51|||Cox mixed effects model|||||0.51|0.25|<0.001
71144755|NCT04196686|141782781|OTHER||Mean Difference (Net)|0.455||||0.2|TWO_SIDED|95.0|0.32|0.59|||Linear mixed effects model|||Analysis was controlled for dominant hand treatment assignment, dominant hand order, and gender. Overall mean difference calculated from regression model.||0.59|0.32|0.200
71144756|NCT04196686|141782782|OTHER||Mean Difference (Net)|0.002||||0.047|TWO_SIDED|95.0|0.00007|0.00368|||Linear mixed effects model|||The variables in the physiologic model were SCRD change over time and the SCRD change between groups, defined as those with and without VR.||0.00368|0.00007|0.047
71144757|NCT02587221|141782789|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of RT-PCR confirmed due to any strain.~An ILI was defined as presence of ≥1 respiratory symptom (e.g. sore throat, cough, sputum production, wheezing, or difficulty breathing) concurrently with ≥1 systemic symptom (temp \>37.2°C/99°F, chills, tiredness, headache, or myalgia) (protocol defined ILI definition)."|Vaccine efficacy (VE)|19.8|||||TWO_SIDED|97.45|-5.27|38.91|||Regression, Cox|Adjusted for covariates||The efficacy of aQIV would be demonstrated if the LL of the two-sided multiplicity adjusted 95%CI for the vaccine efficacy is \>40%||38.91|-5.27|
71144758|NCT02587221|141782794|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of RT-PCR confirmed due to any strain.~An ILI was defined as the presence of fever (temperature \>37.2°C) with cough or sore throat (modified CDC ILI definition)."|Vaccine efficacy (VE)|32.12|||||TWO_SIDED|95.0|10.23|48.67|||Regression, Cox|Adjusted for covariates||||48.67|10.23|
71144759|NCT02587221|141782795|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza antigenically matched to the vaccine strains.~An ILI was defined as the presence of ≥1 respiratory symptom (eg. sore throat, cough, sputum production, wheezing, or difficulty breathing) concurrently with ≥1 systemic symptom (temp \>37.2°C/99°F, chills, tiredness, headache, or myalgia) (protocol defined ILI definition)."|Vaccine efficacy (VE)|49.94|||||TWO_SIDED|95.0|-24.03|79.79|||Regression, Cox|Adjusted for covariates||The efficacy of aQIV would be demonstrated if the LL of the two-sided multiplicity adjusted 95%CI for the vaccine efficacy is \>40%||79.79|-24.03|
71144760|NCT02587221|141782796|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza antigenically matched to the strains selected for the seasonal vaccine.~An ILI was defined as presence of fever (temperature \>37.2°C) with cough or sore throat (modified CDC ILI definition)."|Vaccine efficacy (VE)|61.5|||||TWO_SIDED|95.0|-7.98|86.28|||Regression, Cox|Adjusted for covariates||||86.28|-7.98|
70952692|NCT00461981|141406994|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|3.31||||||95.0|1.46|7.54||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||7.54|1.46|
71144761|NCT02587221|141782797|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any vaccine strain regardless of antigenic match.~An ILI was defined as the presence of ≥1 respiratory symptom (e.g. sore throat, cough, sputum production, wheezing, or difficulty breathing) concurrently with ≥1 systemic symptom (temp \>37.2°C/99°F, chills, tiredness, headache, or myalgia) (protocol defined ILI definition)."|Vaccine efficacy (VE)|28.66|||||TWO_SIDED|95.0|0.05|49.08|||Regression, Cox|Adjusted for covariates||||49.08|0.05|
71144762|NCT02587221|141782798|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza regardless of antigenic match~An ILI was defined as presence of fever (temperature \>37.2°C) with cough or sore throat (modified CDC ILI definition)."|Vaccine efficacy (VE)|33.47|||||TWO_SIDED|95.0|2.56|54.57|||Regression, Cox|Adjusted for covariates||||54.57|2.56|
71144763|NCT02587221|141782799|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza antigenically unmatched to the vaccine strains.~An ILI is the presence of ≥1 respiratory symptom (e.g. sore throat, cough, sputum production, wheezing, or difficulty breathing) concurrently with ≥1 systemic symptom (temp \>37.2°C/99°F, chills, tiredness, headache, or myalgia) (protocol defined ILI definition)."|Vaccine efficacy (VE)|23.79|||||TWO_SIDED|95.0|-9.69|47.05|||Regression, Cox|Adjusted for covariates||||47.05|-9.69|
71144764|NCT02587221|141782800|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza antigenically unmatched to the strains selected for the seasonal vaccine.~An ILI was defined as presence of fever (temperature \>37.2°C) with cough or sore throat (modified CDC ILI definition)."|Vaccine efficacy (VE)|26.11|||||TWO_SIDED|95.0|-11.71|51.13|||Regression, Cox|Adjusted for covariates||||51.13|-11.71|
71144765|NCT02587221|141782805|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of RT-PCR confirmed due to any strain.~An ILI was defined as presence of fever (temperature ≥38°C) with cough (WHO ILI definition)."|Vaccine efficacy (VE)|51.08|||||TWO_SIDED|95.0|28.21|66.67|||Regression, Cox|Adjusted for covariates||||66.67|28.21|
70869920|NCT04115839|141225289|SUPERIORITY||LS Mean Treatment Difference|2.1|STANDARD_ERROR_OF_MEAN|1.45||0.14|TWO_SIDED|95.0|-0.7|5.0||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||5.0|-0.7|0.14
70869921|NCT02577510|141225302|OTHER|||||||0.05|||||||t-test, 1 sided|||Statistical analysis was performed using SPSS Version 21 statistical software (IBM, Armonk, New York). For continuous data, normality was fi rst assessed with the Lilliefors test and then analyzed using a paired t test. Data that did not have a normal distribution, as well as ordinal data, was analyzed using Wilcoxon's signed ranks or McNemar's test. All P values presented were 2-sided and values inferior to 0.05 were considered signifi cant||||0.05
70869922|NCT03535844|141225309|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|independent t-test of change values||||||0.49
71144766|NCT02587221|141782806|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza antigenically matched to the strains selected for the seasonal vaccine.~An ILI was defined as presence of fever (temperature ≥38°C) with cough (WHO ILI definition)"|Vaccine efficacy (VE)|74.96|||||TWO_SIDED|95.0|-17.93|94.68|||Regression, Cox|Adjusted for covariates||||94.68|-17.93|
71144767|NCT02587221|141782807|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza regardless of antigenic match.~An ILI was defined as presence of fever (temperature ≥38°C) with cough (WHO ILI definition)."|Vaccine efficacy (VE)|60.17|||||TWO_SIDED|95.0|31.19|76.94|||Regression, Cox|Adjusted for covariates||||76.94|31.19|
71144768|NCT02587221|141782808|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza antigenically unmatched to the strains selected for the seasonal vaccine.~An ILI was defined as presence of fever (temperature ≥38°C) with cough (WHO ILI definition)."|Vaccine efficacy (VE)|57.02|||||TWO_SIDED|95.0|22.73|76.09|||Regression, Cox|Adjusted for covariates||||76.09|22.73|
70869923|NCT03535844|141225309|SUPERIORITY|||||||0.5672|||||||t-test, 1 sided|Paired t-test (Week 0 and Week 16)||||||0.5672
70869924|NCT03535844|141225309|SUPERIORITY|||||||0.788|||||||t-test, 2 sided|Paired t-test of change values||||||0.788
71144769|NCT02546609|141782809|OTHER|||||||0.0572|||||||ANCOVA|||Analysis of variance (ANOVA) model: with treatment group as the factor. Placebo is used as the reference group.||||0.0572
70869925|NCT03535844|141225310|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|independent t-test of change values||||||0.67
70869926|NCT03535844|141225310|SUPERIORITY|||||||0.8203|||||||t-test, 2 sided|Paired t-test of change values||||||0.8203
71144770|NCT02546609|141782809|OTHER|||||||0.377|||||||ANCOVA|||Analysis of variance (ANOVA) model: with treatment group as the factor. Placebo is used as the reference group.||||0.3770
71144771|NCT02546609|141782810|OTHER|||||||0.3811|||||||Mixed Effect Model Repeat Measurement|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.3811
71144772|NCT02546609|141782810|OTHER|||||||0.8479|||||||Mixed Effect Model Repeat Measurement|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.8479
71144773|NCT02546609|141782811|OTHER|||||||0.7742|||||||Mixed effect Model Repeat Measurement|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.7742
71144774|NCT02546609|141782811|OTHER|||||||0.6666|||||||Mixed effect Model Repeat Measurement|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.6666
71144775|NCT02546609|141782812|OTHER|||||||0.002|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.0020
71144776|NCT02546609|141782812|OTHER|||||||0.0164|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.0164
71144777|NCT02546609|141782813|OTHER|||||||0.4099|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.4099
71144778|NCT02546609|141782813|OTHER|||||||0.1455|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.1455
71144779|NCT02546609|141782814|OTHER|||||||0.2559|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.2559
71144780|NCT02546609|141782814|OTHER|||||||0.9776|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.9776
71144781|NCT02546609|141782815|OTHER|||||||0.2265|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.2265
71144782|NCT02546609|141782815|OTHER|||||||0.8366|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.8366
71144783|NCT02546609|141782816|OTHER|||||||0.347|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.3470
71144784|NCT02546609|141782816|OTHER|||||||0.6221|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.6221
71144785|NCT02546609|141782817|OTHER|||||||0.347|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.3470
71144786|NCT02546609|141782817|OTHER|||||||0.6221|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.6221
71144787|NCT02546609|141782818|OTHER|||||||0.0129|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.0129
71144788|NCT02546609|141782818|OTHER|||||||0.4316|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.4316
71144789|NCT02546609|141782819|OTHER|MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||||0.1946|||||||MMRM|||||||0.1946
70869927|NCT03535844|141225310|SUPERIORITY|||||||0.3882|||||||t-test, 2 sided|Paired t-test of change values||||||0.3882
70869928|NCT03535844|141225311|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|independent t-test of change values||||||0.08
70869929|NCT03535844|141225312|SUPERIORITY|||||||0.7162|||||||t-test, 2 sided|independent t-test of change values||||||0.7162
70869930|NCT03535844|141225312|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|Paired t-test of Week 0 and Week 16 nitric oxide values||||||0.07
70869931|NCT03535844|141225312|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|Paired t-test of Week 0 and Week 16 nitric oxide values||||||<0.05
70869932|NCT03535844|141225313|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|Independent t-test of change values||||||<0.05
70952693|NCT00461981|141406995|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|1.35||||||95.0|0.58|3.04||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||3.04|0.58|
70869933|NCT03535844|141225314|SUPERIORITY|||||||0.4855|||||||t-test, 2 sided|Independent t-test of change triglyceride values||||||0.4855
70869934|NCT03535844|141225314|SUPERIORITY|||||||0.1393|||||||t-test, 2 sided|Independent t-test of change total cholesterol values||||||0.1393
70952694|NCT00461981|141406996|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.44||||||95.0|0.16|1.07||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.07|0.16|
70869935|NCT03535844|141225314|SUPERIORITY|||||||0.2221|||||||t-test, 2 sided|Independent t-test of change LDL cholesterol values||||||0.2221
70869936|NCT03535844|141225314|SUPERIORITY|||||||0.078|||||||t-test, 2 sided|Independent t-test of change HDL cholesterol values||||||0.078
70869937|NCT03535844|141225314|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|Paired t-test of Week 0 and Week 16 HDL cholesterol values||||||<0.05
70869938|NCT03535844|141225314|SUPERIORITY|||||||0.7261|||||||t-test, 2 sided|Paired t-test of Week 0 and Week 16 HDL cholesterol values||||||0.7261
70869939|NCT03535844|141225315|SUPERIORITY|||||||0.1951|||||||t-test, 2 sided|Independent t-test of systolic blood pressure change values||||||0.1951
70952695|NCT00461981|141406997|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|2.46||||||95.0|1.26|5.06||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||5.06|1.26|
70952696|NCT00461981|141406998|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.89||||||95.0|0.7|1.0||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.00|0.70|
70952697|NCT00461981|141406999|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.51||||||95.0|0.23|1.22||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.22|0.23|
70952698|NCT00461981|141407000|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|4.0||||||95.0|4.0|4.0||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||4.00|4.00|
70952699|NCT00461981|141407001|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.8||||||95.0|0.22|3.63||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||3.63|0.22|
70952700|NCT00461981|141407002|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.66||||||95.0|0.25|1.73||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.73|0.25|
70952701|NCT00461981|141407007|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence|||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||< 0.001
70952702|NCT02383940|141407008|SUPERIORITY||Least squares mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.207||0.1|TWO_SIDED|95.0|-0.76|0.06||Threshold for significance = 0.05|MMRM||Difference is sotagliflozin - placebo|Between-group comparison was based on MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week-4 A1C (\<=10%, \>10%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C-by-time interaction as a covariate.||0.06|-0.76|0.10
70952703|NCT02672852|141407025|OTHER||Adjusted percentage difference|70.8|||<|0.001|TWO_SIDED|95.0|65.7|76.0|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the Cochran-Mantel-Haenszel (CMH) test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||76.0|65.7|< 0.001
70952704|NCT02672852|141407026|OTHER||Adjusted percentage difference|76.5|||<|0.001|TWO_SIDED|95.0|70.4|82.5|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||82.5|70.4|< 0.001
70952705|NCT02672852|141407027|OTHER||Adjusted percentage difference|25.9|||<|0.001|TWO_SIDED|95.0|17.3|34.6|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||34.6|17.3|< 0.001
70952706|NCT02672852|141407028|OTHER||Adjusted percentage difference|80.6|||<|0.001|TWO_SIDED|95.0|74.5|86.6|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||86.6|74.5|< 0.001
70952707|NCT02672852|141407029|OTHER||Adjusted percentage difference|45.5|||<|0.001|TWO_SIDED|95.0|40.3|50.8|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||50.8|40.3|< 0.001
70869940|NCT03535844|141225315|SUPERIORITY|||||||0.916|||||||t-test, 2 sided|Independent t-test of diastolic blood pressure change values||||||0.916
70869941|NCT03535844|141225316|SUPERIORITY|||||||0.9882|||||||t-test, 2 sided|independent t-test of malondialdehyde change values||||||0.9882
70952708|NCT02672852|141407030|OTHER||Adjusted percentage difference|44.8|||<|0.001|TWO_SIDED|95.0|39.5|50.0|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||50.0|39.5|< 0.001
70869942|NCT03535844|141225317|SUPERIORITY|||||||0.4408|||||||t-test, 2 sided|Independent t-test of body fat % change values||||||0.4408
70869943|NCT03535844|141225318|SUPERIORITY|||||||0.1487|||||||t-test, 2 sided|Independent t-test of change values||||||0.1487
70869944|NCT03535844|141225319|SUPERIORITY|||||||0.9135|||||||t-test, 2 sided|Independent t-test of change values||||||0.9135
70869945|NCT03535844|141225320|SUPERIORITY|||||||0.5859|||||||t-test, 2 sided|Independent t-test of change values||||||0.5859
70869946|NCT03535844|141225321|SUPERIORITY|||||||0.9379|||||||t-test, 2 sided|Independent t-test of change values||||||0.9379
70869947|NCT03535844|141225322|SUPERIORITY|||||||0.9717|||||||t-test, 2 sided|t-test of change values||||||0.9717
70869948|NCT03535844|141225325|SUPERIORITY|||||||0.7052|||||||t-test, 2 sided|Independent t-test of change values||||||0.7052
70869949|NCT03535844|141225325|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|Paired t-test between Week 0 and Week 16 endothelin-1 concentrations||||||0.07
70869950|NCT03535844|141225325|SUPERIORITY|||||||0.005||||||Paired t-test between Week 0 and Week 16 endothelin-1 concentrations|t-test, 2 sided|||||||0.005
70869951|NCT03535844|141225326|SUPERIORITY|||||||0.9426||||||Independent t-test of change values|t-test, 2 sided|||||||0.9426
70869952|NCT01803204|141225327|SUPERIORITY_OR_OTHER||GEE|1.0||||1|TWO_SIDED|99.0|||||GEE|||||||1.00
70869953|NCT01803204|141225328|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|99.0|||||Mist Effects Model|||||||<0.01
70869954|NCT01803204|141225329|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED|99.0|||||Mist Effect Model|||||||0.81
70869955|NCT01867424|141225380|OTHER||Median of Differences|0.43||||0.0008|TWO_SIDED|||||Median of difference in CER: All cases.|Wilcoxon Test||The relative difference between groups is based on the change from baseline values to the values collected at each of the three time points.|Null Hypothesis: There is no significant difference in contrast enhancement ratio (CER) in prostate cancers upon injection of Eovist. Subgroup analysis of CER in (i) Advanced Disease and (ii) Localized Disease||||0.0008
70952709|NCT02672852|141407031|OTHER||Adjusted percentage difference|62.1|||<|0.001|TWO_SIDED|95.0|56.4|67.9|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||67.9|56.4|< 0.001
70952710|NCT02672852|141407032|OTHER||Adjusted percentage difference|73.9|||<|0.001|TWO_SIDED|95.0|66.0|81.9|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||81.9|66.0|< 0.001
71144790|NCT02546609|141782819|OTHER|||||||0.4697|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.4697
70869956|NCT01867424|141225380|OTHER||Median of Differences|0.42||||0.0039|TWO_SIDED|||||Median of difference in CER: Advanced Disease Cases.|Wilcoxon Test|||||||0.0039
70869957|NCT01867424|141225380|OTHER||Median of Differences|0.475||||0.084|TWO_SIDED|||||Median of difference in CER: Local Disease Cases.|Wilcoxon Test|||||||0.084
70869958|NCT01867424|141225380|OTHER||Median Difference CER|0.17||||0.25|TWO_SIDED||||||Wilcoxon Test|||Analysis of CER from baseline to 40 minutes after Eovist injection.||||0.25
71144791|NCT02546609|141782820|OTHER|||||||0.3474|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.3474
71144792|NCT02546609|141782820|OTHER|||||||0.8832|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.8832
71144793|NCT01292486|141782884|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 2 days.|Median Difference (Final Values)|0.0|||<|0.025|TWO_SIDED|95.0|0.0|0.0|||Hodges-Lehman estimation|||The null hypothesis was that the median day to neutrophil recovery in this study was more than two days longer than historical controls.||0.0|0.0|<0.025
70869959|NCT01867424|141225380|OTHER||Median Difference CER|0.27||||0.1602|TWO_SIDED||||||Wilcoxon Test|||Analysis of CER from baseline to 60 minutes after Eovist injection.||||0.1602
70869960|NCT01867424|141225380|OTHER||Median Difference CER|0.29||||0.0078|TWO_SIDED||||||Wilcoxon Test|||Analysis of CER from baseline to 40 minutes after Eovist injection.||||0.0078
70869961|NCT01867424|141225380|OTHER||Median Difference CER|0.34||||0.0039|TWO_SIDED||||||Wilcoxon Test|||Analysis of CER from baseline to 60 minutes after Eovist injection.||||0.0039
70869962|NCT01867424|141225380|OTHER||Median Difference CER|0.27||||0.0046|TWO_SIDED||||||Wilcoxon Test|||Analysis of CER from baseline to 40 minutes after Eovist injection; Total cases.||||0.0046
70869963|NCT01867424|141225380|OTHER||Median Difference CER|0.33||||0.0017|TWO_SIDED||||||Wilcoxon Test|||Analysis of CER from baseline to 60 minutes after Eovist injection; Total cases.||||0.0017
70869964|NCT01867424|141225382|OTHER||Spearman r|-0.137||||0.5761|TWO_SIDED|95.0|-0.5665|0.3511|||Nonparametric Spearman correlation|The calculation of Spearman correlation is between baseline PSA and CER at 20 minutes post Eovist injection.||Null Hypothesis: There is no significant difference in contrast enhancement ratio (CER) with Eovist injection based on baseline Prostate-specific antigen (PSA) levels at 20-minute timepoint.||0.3511|-0.5665|0.5761
70869965|NCT01867424|141225382|OTHER||Spearman r|-0.257||||0.3033|TWO_SIDED|95.0|-0.6549|0.2526|||nonparametric Spearman correlation|||Analyses include calculation of Spearman correlation between baseline Prostate-specific antigen (PSA) and CER at 40 minutes post Eovist injection.||0.2526|-0.6549|0.3033
70869966|NCT01867424|141225382|OTHER||Spearman r|-0.2861||||0.2351|TWO_SIDED|95.0|-0.6634|0.2071|||nonparametric Spearman correlation|||Analyses include calculation of Spearman correlation between baseline Prostate-specific antigen (PSA) and CER at 60 minutes post Eovist injection.||0.2071|-0.6634|0.2351
70869967|NCT01867424|141225382|OTHER||Median Difference (actual)|-0.47||||0.111|TWO_SIDED||||||Mann Whitney|||Analyses include analysis of CER at 20 minutes after Eovist injection based on baseline Prostate-specific antigen (PSA) stratifying by PSA \< or \>/= 20ng/ml.||||0.111
70869968|NCT01867424|141225382|OTHER||Median Difference (actual)|-0.775||||0.7738|TWO_SIDED||||||Mann Whitney|||Analyses include analysis of CER at 20 minutes after Eovist injection based on baseline Prostate-specific antigen (PSA) stratifying by PSA \< or \>/= 20ng/ml.||||0.7738
70869969|NCT01056653|141225384|SUPERIORITY_OR_OTHER||||||=|0.03|||||||ANCOVA|F(2,107)=3.48, partial n2=0.061, observed power=0.639||ANCOVA - Group Comparison of Parent Total Score on PCITS at 8 months, controlling for scores at baseline (4 months). Group entered as as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||=0.03
70869970|NCT01056653|141225384|SUPERIORITY_OR_OTHER|||||||0.03||||||Bonferroni adjustments for multiple comparisons used|ANOVA|||Pairwise Group Comparison based on estimated marginal means - Parent Total Scores||||0.03
70869971|NCT01056653|141225384|SUPERIORITY_OR_OTHER|||||||0.534||||||Bonferroni adjustment for multiple comparisons used|ANCOVA|||Pairwise Group Comparison based on estimated marginal means - Parent Total Scores||||0.534
70869972|NCT01056653|141225384|SUPERIORITY_OR_OTHER|||||||0.047|||||||ANCOVA|F(2,107)=3.145, partial n2=0.056, observed power=0.593.||ANCOVA - Group Comparison of Cognitive Growth Fostering Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.047
70869973|NCT01056653|141225384|SUPERIORITY_OR_OTHER|||||||0.056||||||Bonferroni adjustments for multiple comparisons used|ANCOVA|||Pairwise Group Comparison based on estimated marginal means - Cognitive Growth Fostering Subscale||||0.056
70869974|NCT01056653|141225384|SUPERIORITY_OR_OTHER|||||||0.267||||||Bonferroni adjustments for multiple comparisons used|ANCOVA|||Pairwise Group Comparison based on estimated marginal means - Cognitive Growth Fostering Subscale||||0.267
70869975|NCT01056653|141225384|SUPERIORITY_OR_OTHER|||||||0.036|||||||ANCOVA|F(2,107)=3.440, partial n2=0.060, observed power=0.634||ANCOVA - Group Comparison of Socio-Emotional Growth Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.036
70869976|NCT01056653|141225384|SUPERIORITY_OR_OTHER|||||||0.036||||||Bonferroni adjustments for multiple comparisons used|ANCOVA|||Pairwise Group Comparison based on estimated marginal means - Socio-Emotional Growth Fostering Subscale||||0.036
70869977|NCT01056653|141225384|SUPERIORITY_OR_OTHER|||||||1||||||Bonferroni adjustments for multiple comparisons used|ANCOVA|||Pairwise Group Comparison based on estimated marginal means - Socio-Emotional Growth Fostering Subscale||||1.00
70869978|NCT01056653|141225384|SUPERIORITY_OR_OTHER|||||||0.665|||||||ANCOVA|F(2,107)=0.409||ANCOVA - Group Comparison of Sensitivity to Cues Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.665
70869979|NCT01056653|141225384|SUPERIORITY_OR_OTHER|||||||0.732|||||||ANCOVA|F(2,107)=0.313||ANCOVA - Group Comparison of Response to Distress Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.732
70869980|NCT01056653|141225385|SUPERIORITY_OR_OTHER|||||||0.61|||||||ANCOVA|F(2,107)=0.49||ANCOVA - Group Comparison of Parent Domain scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.61
70869981|NCT01056653|141225385|SUPERIORITY_OR_OTHER|||||||0.38|||||||ANCOVA|F(2,107)=0.96||ANCOVA - Group Comparison of Child Domain scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.38
70869982|NCT01056653|141225386|SUPERIORITY_OR_OTHER|||||||0.11|||||||ANCOVA|F(2,106)=2.24.||ANCOVA - Group Comparison of WPL-R scores - Evaluation Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.11
70869983|NCT01056653|141225386|SUPERIORITY_OR_OTHER|||||||0.686|||||||ANCOVA|F(2,106)=0.379||ANCOVA - Group Comparison of WPL-R scores - Centrality Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.686
70952711|NCT02672852|141407033|OTHER||Adjusted percentage difference|21.2|||<|0.001|TWO_SIDED|95.0|13.7|28.7|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||28.7|13.7|< 0.001
70952712|NCT02672852|141407034|OTHER||Adjusted percentage difference|33.1|||<|0.001|TWO_SIDED|95.0|24.0|42.2|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||42.2|24.0|< 0.001
70952713|NCT02672852|141407035|OTHER||Adjusted percentage difference|33.7|||<|0.001|TWO_SIDED|95.0|23.2|44.2|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||44.2|23.2|< 0.001
70869984|NCT01056653|141225386|SUPERIORITY_OR_OTHER|||||||0.121|||||||ANCOVA|F(2,106)=2.158||ANCOVA - Group Comparison of WPL-R scores - Life Change Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.121
70869985|NCT01847274|141225396|SUPERIORITY||Hazard Ratio (HR)|0.27|||<|0.0001|TWO_SIDED|95.0|0.173|0.41||Two-sided P-value. PFS was independently evaluated in gBRCAmut cohort and non-gBRCAmut cohort.|Log Rank|Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.|Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.|||0.410|0.173|<0.0001
70869986|NCT01847274|141225397|SUPERIORITY||Hazard Ratio (HR)|0.38|||<|0.0001|TWO_SIDED|95.0|0.243|0.586||Two-sided P-value. PFS was independently evaluated in gBRCAmut cohort and non-gBRCAmut cohort. Hierarchical testing: HRD+ subset tested first. If HRD+ subset demonstrated statistical significance, overall non-gBRCA cohort was then tested|Log Rank|Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.|Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.|||0.586|0.243|<0.0001
70869987|NCT01847274|141225398|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.338|0.607||Two-sided P-value. PFS was independently evaluated in gBRCAmut cohort and non-gBRCAmut cohort. Hierarchical testing: HRD+ subset tested first. If HRD+ subset demonstrated statistical significance, overall non-gBRCA cohort was then tested.|Log Rank|Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.|Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.|||0.607|0.338|<0.0001
70869988|NCT01847274|141225399|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.0005|TWO_SIDED|95.0|0.412|0.783||Two-sided p-value|Log Rank|||||0.783|0.412|0.0005
70869989|NCT01847274|141225400|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.454|0.74||Two-sided P-value.|Log Rank|||||0.740|0.454|<0.0001
70869990|NCT01847274|141225401|SUPERIORITY||Hazard Ratio (HR)|0.39|||<|0.0001|TWO_SIDED|95.0|0.268|0.561||Two-sided P-value.|Log Rank|||||0.561|0.268|<0.0001
70869991|NCT01847274|141225402|SUPERIORITY||Hazard Ratio (HR)|0.56|||<|0.0001|TWO_SIDED|95.0|0.428|0.727||Two-sided P-value.|Log Rank|||||0.727|0.428|<0.0001
70869992|NCT01847274|141225403|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0302|TWO_SIDED|95.0|0.5|0.968||Two-sided P-value.|Log Rank|||||0.968|0.500|0.0302
70869993|NCT01847274|141225404|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0748|TWO_SIDED|95.0|0.627|1.022||Two-sided P-value.|Log Rank|||||1.022|0.627|0.0748
70869994|NCT01847274|141225405|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.358|TWO_SIDED|95.0|0.606|1.198||Two-sided P-value.|Log Rank|||||1.198|0.606|0.3580
70869995|NCT01847274|141225406|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.6868|TWO_SIDED|95.0|0.813|1.369||Two-sided P-value.|Log Rank|||||1.369|0.813|0.6868
71144794|NCT04369404|141782891|SUPERIORITY|We hypothesize that participants who received the decision aid will have higher knowledge. This is pilot study, thus we did not have a power calculation.|Mean Difference (Final Values)|12.0||||0.06|TWO_SIDED|95.0|0.7|24.6|||t-test, 2 sided|||||24.6|0.7|0.06
71144795|NCT04369404|141782892|OTHER||Pearson Chi-Square|2.97||||0.085|TWO_SIDED||||||Chi-squared|||"a chisquare test was conducted to determine if the proportion of treatment unsure responses were different between the usual care and intervention arms."||||0.085
71144796|NCT04369404|141782893|OTHER||Pearson Chi-Square|1.524||||0.47|TWO_SIDED||||||Chi-squared|||||||0.47
71144797|NCT00265564|141782903|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Mixed Models Analysis|||We investigated treatment condition differences in change of drug and alcohol use over four time-points using generalized linear mixed modeling analyses. A trajectory for each participant was modeled yielding estimates of baseline scores (intercept), slope, and error. Four between-person parameters were estimated: average baseline score for all participants, average slope over time in TAU condition, effect of being in SS on average intercept, effect of being in SS on average slope.||||> .05
71144798|NCT00265564|141782904|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
71144799|NCT00265564|141782905|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Mixed Models Analysis|||Generalized linear mixed modeling analysis||||>.05
71144800|NCT01553084|141782906|SUPERIORITY||Odds Ratio (OR)|1.2||||0.3623|TWO_SIDED|95.0|0.8|1.7|||Regression, Logistic|||Combination NRT will be compared statististically versus Nicotine patch only (the reference or control group).||1.7|0.8|.3623
71144801|NCT01553084|141782906|SUPERIORITY||Odds Ratio (OR)|0.9||||0.1947|TWO_SIDED|95.0|0.6|1.2|||Regression, Logistic|||Varenicline will be compared statististically versus Nicotine patch only (the reference or control group).||1.2|0.6|.1947
71144802|NCT01553084|141782907|SUPERIORITY||Hazard Ratio (HR)|0.915||||0.3613|TWO_SIDED|95.0|0.756|1.107|||Regression, Cox|||||1.107|.756|.3613
71144803|NCT01553084|141782907|SUPERIORITY||Hazard Ratio (HR)|0.943||||0.5503|TWO_SIDED|95.0|0.779|1.142|||Regression, Cox|||||1.142|.779|.5503
71144804|NCT01553084|141782908|SUPERIORITY||Odds Ratio (OR)|1.5||||0.03|TWO_SIDED|95.0|1.1|2.2|||Regression, Logistic|||||2.2|1.1|.03
71144805|NCT01553084|141782908|SUPERIORITY||Odds Ratio (OR)|0.8||||0.19|TWO_SIDED|95.0|0.6|1.1|||Regression, Logistic|||||1.1|0.6|.19
71144806|NCT01553084|141782909|SUPERIORITY||Mean Difference (Final Values)|-0.00612|STANDARD_ERROR_OF_MEAN|0.00625||0.3282|TWO_SIDED||||||t-test, 2 sided|df=710||||||.3282
71144807|NCT03988400|141782910|SUPERIORITY|||||||1||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||1
71144808|NCT03988400|141782911|SUPERIORITY|||||||0.017||||||The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||||||0.017
71144809|NCT03988400|141782912|SUPERIORITY|||||||1||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||1
71144810|NCT03988400|141782913|SUPERIORITY|||||||0.72||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.72
71144811|NCT03988400|141782914|SUPERIORITY|||||||0.001||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.001
71144812|NCT03988400|141782915|SUPERIORITY|||||||0.68||||||The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||||||0.68
71144813|NCT03988400|141782916|SUPERIORITY|||||||0.25||||||The a priori threshold for statistical significance was 0.05|t-test, 2 sided|||||||0.25
71144814|NCT03988400|141782917|SUPERIORITY|||||||0.69||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.69
71144815|NCT03988400|141782918|SUPERIORITY|||||||0.2||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.20
71144816|NCT03988400|141782919|SUPERIORITY|||||||0.62||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.62
71144817|NCT04201431|141782921|OTHER|Comparison of pooled data from Groups 1 and 2 volunteers who completed primary CHMI with pooled data of infectivity controls undergoing primary CHMI from VAC069 study running in parallel (NCT03797989).||||||0.01||||||Two tailed p value reported for Mann-Whitney test comparing infectivity controls with vaccinees|Wilcoxon (Mann-Whitney)|||Comparison of parasite multiplication rate in vaccinated subjects compared to infectivity controls in a blood-stage controlled human malaria infection model||||0.01
71144818|NCT01791244|141782959|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.48||||0.9148|TWO_SIDED|95.0|-8.3|9.25|||linear mixed model|||Linear mixed model, with baseline value, time, Expanded Disability Status Score (EDSS) at baseline and sex as fixed factors was used for the analysis.||9.25|-8.30|0.9148
71144819|NCT02893293|141783076|OTHER|||||||0.002||||||A p-value less than the a priori threshold of 0.05 was considered statistically significant.|Mixed Models Analysis|Mixed effects model including a random effect term accounting for correlation among the measures with a same patient.||||||0.002
71144820|NCT02893293|141783077|OTHER|||||||0.02||||||A p-value less than the a priori threshold of 0.05 was considered statistically significant.|Mixed Models Analysis|Mixed effects model including a random effect term accounting for correlation among the measures with a same patient.||||||0.02
71144821|NCT02960217|141783108|SUPERIORITY||Hodges-Lehmann estimate (Median Diff.)|1.46||||0.2684|TWO_SIDED|95.0|-1.12|4.36||Hodges-Lehmann estimate of the location shift with 95% confidence interval (CI) and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Participants completing both UX007 treatment period and placebo period (n=42). Per protocol, when the normality assumption is not met (p value for Wilk-Shapiro test \< 0.05), Wilcoxon rank-sum test will be considered as the primary analysis to assess treatment difference in movement disorder event frequency.||4.36|-1.12|0.2684
70869996|NCT01847274|141225407|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0061|TWO_SIDED|95.0|0.451|0.878||Two-sided P-value.|Log Rank|||||0.878|0.451|0.0061
70869997|NCT01847274|141225408|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.1674|TWO_SIDED|95.0|0.654|1.077||Two-sided P-value.|Log Rank|||||1.077|0.654|0.1674
70869998|NCT01847274|141225425|SUPERIORITY|||||||0.7969|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.7969
70869999|NCT01847274|141225425|SUPERIORITY|||||||0.8794|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.8794
70870000|NCT01847274|141225426|SUPERIORITY|||||||0.2399|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.2399
70870001|NCT01847274|141225426|SUPERIORITY|||||||0.4584|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.4584
70870002|NCT01847274|141225427|SUPERIORITY|||||||0.8566|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.8566
70952714|NCT04308590|141407037|EQUIVALENCE|The primary analysis will determine whether there is a difference between treatment groups in terms of change from Baseline to Week 22 in 24-hour average SBP. This was performed using a linear mixed-model-for-repeated-measures (MMRM) analysis using a placebo wash-out multiple imputation for treatment discontinuation and for patients that use rescue medication.|Least squares mean difference|-2.67||||0.416|TWO_SIDED|95.0|-9.096|3.766|||Mixed Models Analysis|||||3.766|-9.096|0.4160
70952715|NCT02175641|141407130|OTHER|Generalized linear mixed-effects models with a logistic link|Odds Ratio (OR)|1.07|||>|0.05|TWO_SIDED|95.0|0.62|1.84|||Regression, Logistic|||||1.84|0.62|>0.05
70952716|NCT02175641|141407131|OTHER|Mixed effect models controlling for study site.|Time by treatment interaction coefficien|0.15|STANDARD_ERROR_OF_MEAN|0.59||0.804|TWO_SIDED||||||Mixed Models Analysis|||||||0.804
70952717|NCT02175641|141407132|OTHER||Time*treatment interaction coefficient|0.05|STANDARD_ERROR_OF_MEAN|0.09||0.91|TWO_SIDED||||||Mixed Models Analysis|||||||0.91
70952718|NCT02175641|141407133|OTHER|Mixed effect models controlling for study site.|time*treatment interaction coefficient|-0.34|STANDARD_ERROR_OF_MEAN|0.74||0.64|TWO_SIDED||||||Mixed Models Analysis|||||||0.64
70870003|NCT01847274|141225427|SUPERIORITY|||||||0.4705|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.4705
70870004|NCT01847274|141225428|SUPERIORITY|||||||0.8521|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.8521
70870005|NCT01847274|141225428|SUPERIORITY|||||||0.9923|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.9923
70870006|NCT01847274|141225429|SUPERIORITY|||||||0.9997|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.9997
70870007|NCT01847274|141225429|SUPERIORITY|||||||0.3518|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.3518
70870008|NCT01847274|141225430|SUPERIORITY|||||||0.9367|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.9367
70870009|NCT01847274|141225430|SUPERIORITY|||||||0.2502|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.2502
70870010|NCT01847274|141225431|SUPERIORITY|||||||0.5037|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.5037
70870011|NCT01847274|141225431|SUPERIORITY|||||||0.164|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.1640
70870012|NCT01847274|141225432|SUPERIORITY|||||||0.9599|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.9599
70870013|NCT01847274|141225432|SUPERIORITY|||||||0.247|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.2470
70870014|NCT01847274|141225433|SUPERIORITY|||||||0.5921|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.5921
70870015|NCT01847274|141225433|SUPERIORITY|||||||0.7459|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.7459
70870016|NCT01847274|141225434|SUPERIORITY|||||||0.0259|||||||Pearson's Chi-squared test|||||||0.0259
70870017|NCT01847274|141225434|SUPERIORITY|||||||0.2798|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.2798
70870018|NCT01847274|141225441|SUPERIORITY||Ratio of Least square mean|1.1|||||TWO_SIDED|90.0|0.997|1.216||||||||1.216|0.997|
70870019|NCT01847274|141225442|SUPERIORITY||Ratio of Least square mean|1.068|||||TWO_SIDED|90.0|0.978|1.166||||||||1.166|0.978|
70870020|NCT01847274|141225443|SUPERIORITY||Ratio of Least square mean|0.785|||||TWO_SIDED|90.0|0.695|0.886||||||||0.886|0.695|
70870021|NCT03727230|141225447|OTHER||||||<|0.001|||||||Chi-squared|||In this study, a single-arm clinical trial was conducted. The summarized alloanti-D rate (203/720, 28.2%; 95% CI, 19%-32%) in truly RhD-negative patients with similar mixed diseases after RhD+ RBC transfusion reported in the meta-analysis (Ji YL, et al. Vox Sang 2022; 117: 633-40) was used as the control for comparison with alloanti-D rate identified in Asian-type DEL patients after RhD+ RBC transfusion in the clinical trial.||||< 0.001
70870022|NCT03470441|141225461|OTHER||||||||||||||descriptive||||As little data exists on the incidence of arrhythmias that occur over an extended period of time following AMI, descriptive analysis of the primary endpoints (Arrhythmias of Interest at 48 hours and 14 days for overall and anterior infarcts) was appropriate in this study due to the absence of an externally validated benchmark which would normally serve as the basis for hypothesis testing of FDY-5301's effect on arrhythmias.|||
70870023|NCT03470441|141225466|SUPERIORITY||Median Difference (Final Values)|-3.2||||0.32|TWO_SIDED|95.15|-10.8|3.1|||Wilcoxon (Mann-Whitney)|||Wilcoxon Mann-Whitney Test comparing placebo to FDY-5301 treated subjects (combined low dose, intermediate dose, and high dose).||3.1|-10.8|0.32
70952719|NCT02175641|141407134|OTHER|Mixed effect models controlling for study site.|Time*treatment interaction coefficient|0.08|STANDARD_ERROR_OF_MEAN|0.09||0.38|TWO_SIDED||||||Mixed Models Analysis|||||||0.38
70952720|NCT02175641|141407135|OTHER|Mixed effect models controlling for study site.|Time*treatment interaction coefficient|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.39|TWO_SIDED||||||Mixed Models Analysis|||||||0.39
70952721|NCT02175641|141407136|OTHER|Mixed effect models controlling for study site.|Time*treatment interaction coefficient|0.23|STANDARD_ERROR_OF_MEAN|0.37||0.52|TWO_SIDED||||||Mixed Models Analysis|||||||0.52
70952722|NCT02175641|141407137|OTHER|Mixed effect models controlling for study site.|Time*treatment interaction coefficient|3.83|STANDARD_ERROR_OF_MEAN|3.28||0.24|TWO_SIDED||||||Mixed Models Analysis|||||||0.24
71144822|NCT02960217|141783108|SUPERIORITY||||||<|0.0001|||||||Wilk-Shapiro test for normality|||||||< 0.0001
70870024|NCT03470441|141225468|SUPERIORITY||Median Difference (Final Values)|-4.4||||0.46|TWO_SIDED|95.16|-20.2|12.1|||Wilcoxon (Mann-Whitney)|||Wilcoxon Mann-Whitney Test Comparing placebo to anterior infarcts FDY-5301 treated subjects (low, intermediate, and high) combined into one group.||12.10|-20.2|0.46
70870025|NCT03470441|141225474|SUPERIORITY||Median Difference (Final Values)|3.7||||0.25|TWO_SIDED|95.11|-3.6|10.6|||Wilcoxon (Mann-Whitney)|||Wilcoxon Mann-Whitney Test comparing placebo to FDY-5301 treated subjects (combined low dose, intermediate dose, and high dose).||10.6|-3.6|0.25
70870026|NCT03470441|141225476|SUPERIORITY||Median Difference (Final Values)|4.9||||0.31|TWO_SIDED|95.16|-7.0|16.9|||Wilcoxon (Mann-Whitney)|||Wilcoxon Mann-Whitney Test comparing placebo to anterior infarcts FDY-5301 treated subjects (combined low dose, intermediate dose, and high dose).||16.9|-7|0.31
70870027|NCT03768414|141225480|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.41|TWO_SIDED|95.0|0.72|1.14|||Log Rank|||||1.14|0.72|0.41
70870028|NCT03187197|141225510|OTHER|||||||0.0001|||||||Paired t-test|||Within group comparison of Baseline convenience with that of Visit 2.||||0.0001
70870029|NCT03187197|141225510|OTHER|||||||0.0001|||||||Paired t-test|||Within group comparison of Baseline convenience with that of Visit 3.||||0.0001
70952723|NCT03921723|141407141|EQUIVALENCE|Bioequivalence is established when the 90 percent (%) confidence interval of the ratio for AUC (0 to t) between treatment formulations (Prototype A versus DTG Reference Treatment) are within the range of 0.80 to 1.25|Ratio|0.97|||||TWO_SIDED|90.0|0.91|1.03||||||||1.03|0.91|
71144823|NCT02960217|141783111|SUPERIORITY||Hodges-Lehmann estimate (Median Diff.)|25.0||||0.6419|TWO_SIDED|95.0|-62.5|91.5||Hodges-Lehmann estimate of the location shift with 95% CI and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Number of participants in this analysis completed both UX007 treatment period and placebo treatment period (n=34).||91.5|-62.5|0.6419
71144824|NCT02960217|141783111|SUPERIORITY|||||||0.0005|||||||Wilk-Shapiro Test for Normality|||||||0.0005
71144825|NCT02960217|141783112|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.91||0.9513|TWO_SIDED|95.0|-2.0|1.9||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||1.9|-2.0|0.9513
71144826|NCT02960217|141783112|SUPERIORITY|||||||0.8214|||||||Wilk-Shapiro Test for Normality|||||||0.8214
71144827|NCT02960217|141783113|SUPERIORITY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.32||0.1572|TWO_SIDED|95.0|-0.8|4.7||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||4.7|-0.8|0.1572
70870030|NCT03187197|141225510|OTHER|||||||0.0031|||||||Paired t-test|||Within group comparison of Baseline satisfaction with that of Visit 2.||||0.0031
70870031|NCT03187197|141225510|OTHER|||||||0.0001|||||||Paired t-test|||Within group comparison of Baseline satisfaction with that of Visit 3.||||0.0001
71144828|NCT02960217|141783113|SUPERIORITY|||||||0.8451|||||||Wilk-Shapiro Test for Normality|||||||0.8451
71144829|NCT02960217|141783114|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.66||0.8345|TWO_SIDED|95.0|-3.8|3.1||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||3.1|-3.8|0.8345
71144830|NCT02960217|141783114|SUPERIORITY|||||||0.2894|||||||Wilk-Shapiro Test for Normality|||||||0.2894
71144831|NCT02960217|141783115|SUPERIORITY|||||||0.0005|||||||Wilk-Shapiro Test for Normality|||||||0.0005
71144832|NCT02960217|141783115|SUPERIORITY||Hodges-Lehmann estimate (Median Diff.)|0.2||||0.4898|TWO_SIDED|95.0|-5.4|5.8||Hodges-Lehmann estimate of the location shift with 95% CI and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Number of participants in this analysis completed both UX007 treatment period and placebo treatment period (n=21).||5.8|-5.4|0.4898
71144833|NCT02960217|141783116|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|1.42||0.5853|TWO_SIDED|95.0|-2.2|3.8||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||3.8|-2.2|0.5853
71144834|NCT02960217|141783116|SUPERIORITY|||||||0.1066|||||||Wilk-Shapiro Test for Normality|||||||0.1066
71144835|NCT02960217|141783117|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|1.33||0.1875|TWO_SIDED|95.0|-4.6|1.0||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||1.0|-4.6|0.1875
71144836|NCT02960217|141783117|SUPERIORITY|||||||0.2034|||||||Wilk-Shapiro Test for Normality|||||||0.2034
71144837|NCT02960217|141783118|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.56||0.1138|TWO_SIDED|95.0|-0.7|5.9||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||5.9|-0.7|0.1138
71144838|NCT02960217|141783118|SUPERIORITY|||||||0.1478|||||||Wilk-Shapiro Test for Normality|||||||0.1478
70870032|NCT03187197|141225511|OTHER|||||||0.7879|||||||t-test, 2 sided|||Between group comparison of Visit 2 treatment convenience before PSM.||||0.7879
70870033|NCT03187197|141225511|OTHER|||||||0.611|||||||t-test, 2 sided|||Between group comparison of Visit 3 treatment convenience before PSM.||||0.6110
70870034|NCT03187197|141225511|OTHER|||||||0.0832|||||||t-test, 2 sided|||Between group comparison of Visit 2 treatment satisfaction before PSM.||||0.0832
70870035|NCT03187197|141225511|OTHER|||||||0.6488|||||||t-test, 2 sided|||Between group comparison of Visit 3 treatment satisfaction before PSM.||||0.6488
70870036|NCT03187197|141225511|OTHER|||||||0.1301|||||||Two sample T test|||Between group comparison of Visit 2 treatment convenience after PSM.||||0.1301
70870037|NCT03187197|141225511|OTHER|||||||0.1257|||||||Two sample T test|||Between group comparison of Visit 2 treatment satisfaction after PSM.||||0.1257
70870038|NCT00621985|141225560|SUPERIORITY_OR_OTHER||Percent Difference|-19.0||||0.09||95.0|||||t-test, 2 sided|||"A t-test was performed comparing the mean long transformed area under the curve of 17-hydroxyprogesterone between the dexamethasone and hydrocortisone arms. The percent difference in mean log AUC was calculated as:~(Mean log AUC on dexamethasone - Mean log AUC on hydrocortisone)/Mean log AUC on hydrocortisone"||||0.09
70870039|NCT00706823|141225582|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||||||0.02
70870040|NCT00706823|141225583|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Fisher Exact|||||||0.22
70870041|NCT00706823|141225585|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||t-test, 2 sided|||||||0.22
70870042|NCT00706823|141225587|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.11||||0.03|TWO_SIDED|95.0|1.1|58.6|||Regression, Logistic|||||58.6|1.1|0.03
70870043|NCT00590720|141225603|SUPERIORITY_OR_OTHER|||||||0.4|||||||Two-sample t-test|||||||0.40
70870044|NCT00590720|141225604|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Two-sample t-test|||||||<0.01
70870045|NCT00590720|141225605|SUPERIORITY_OR_OTHER|||||||0.53|||||||Two-sample t-test|||||||0.53
70870046|NCT00590720|141225606|SUPERIORITY_OR_OTHER|||||||0.22|||||||Two-sample t-test|||||||0.22
70870047|NCT00590720|141225607|SUPERIORITY_OR_OTHER|||||||0.16|||||||Two-sample t-test|||||||0.16
70870048|NCT00590720|141225608|SUPERIORITY_OR_OTHER|||||||0.52|||||||Two-sample t-test|||||||0.52
70952724|NCT03921723|141407141|EQUIVALENCE|Bioequivalence is established when the 90% confidence interval of the ratio for AUC (0 to t) between treatment formulations (Prototype B versus DTG Reference Treatment) are within the range of 0.80 to 1.25|Ratio|1.12|||||TWO_SIDED|90.0|1.05|1.2||||||||1.20|1.05|
71144839|NCT02960217|141783119|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.62||0.5505|TWO_SIDED|95.0|-4.6|2.6||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||2.6|-4.6|0.5505
71144840|NCT02960217|141783119|SUPERIORITY|||||||0.4459|||||||Wilk-Shapiro Test for Normality|||||||0.4459
71144841|NCT02960217|141783120|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|2.84||0.5544|TWO_SIDED|95.0|-8.1|4.6||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||4.6|-8.1|0.5544
71144842|NCT02960217|141783120|SUPERIORITY|||||||0.1104|||||||Wilk-Shapiro Test for Normality|||||||0.1104
71144843|NCT02960217|141783121|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|3.27||0.7145|TWO_SIDED|95.0|-8.5|6.1|||ANCOVA|||||6.1|-8.5|0.7145
71144844|NCT02960217|141783121|SUPERIORITY|||||||0.8255|||||||Wilk-Shapiro Test for Normality|||||||0.8255
71144845|NCT02960217|141783122|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.82||0.4176|TWO_SIDED|95.0|-2.5|5.6||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||5.6|-2.5|0.4176
71144846|NCT02960217|141783122|SUPERIORITY|||||||0.6557|||||||Wilk-Shapiro Test for Normality|||||||0.6557
71144847|NCT02960217|141783123|SUPERIORITY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.09||0.0935|TWO_SIDED|95.0|-0.4|4.5||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||4.5|-0.4|0.0935
71144848|NCT02960217|141783123|SUPERIORITY|||||||0.7267|||||||Wilk-Shapiro Test for Normality|||||||0.7267
71144849|NCT02960217|141783124|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.28||0.8329|TWO_SIDED|95.0|-0.6|0.5||Based on an ANCOVA model including covariate for study baseline CGI-S score, fixed effects for treatment sequence, treatment group, period, and a random effect for subject within the sequence.|ANCOVA|||||0.5|-0.6|0.8329
71144850|NCT02960217|141783124|SUPERIORITY|||||||0.2348|||||||Wilk-Shapiro Test for Normality|||||||0.2348
71144851|NCT02960217|141783126|SUPERIORITY|||||||0.0315|||||||Wilk-Shapiro Test for Normality|||||||0.0315
71144852|NCT02960217|141783126|SUPERIORITY||Hodges-Lehmann estimate (Median Diff.)|-0.5||||0.2425|TWO_SIDED|95.0|-1.5|0.5||Hodges-Lehmann estimate of the location shift with 95% CI and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Number of participants in this analysis completed both UX007 treatment period and placebo treatment period (n=13).||0.5|-1.5|0.2425
71144853|NCT02960217|141783127|SUPERIORITY|||||||0.0072|||||||Wilk-Shapiro Test for Normality|||||||0.0072
71144854|NCT02960217|141783127|SUPERIORITY||Hodges-Lehmann estimate (Median Diff.)|0.0||||1|TWO_SIDED|95.0|-14.5|13.5||Hodges-Lehmann estimate of the location shift with 95% CI and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Number of participants in this analysis completed both UX007 treatment period and placebo treatment period (n=12).||13.5|-14.5|1.0000
71144855|NCT02960217|141783128|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.54||0.1076|TWO_SIDED|95.0|-0.3|2.2||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for subject within the sequence.|ANCOVA|||||2.2|-0.3|0.1076
71144856|NCT02960217|141783128|SUPERIORITY|||||||0.7698|||||||Wilk-Shapiro Test for Normality|||||||0.7698
71144857|NCT02960217|141783129|SUPERIORITY|||||||0.0138|||||||Wilk-Shapiro Test for Normality|||||||0.0138
71144858|NCT02960217|141783129|SUPERIORITY||Hodges-Lehmann estimate (Median Diff.)|2.0||||0.3907|TWO_SIDED|95.0|-3.5|20.5||Hodges-Lehmann estimate of the location shift with 95% CI and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Number of participants in this analysis completed both UX007 treatment period and placebo treatment period (n=13).||20.5|-3.5|0.3907
71144859|NCT02960217|141783130|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.51||0.5233|TWO_SIDED|95.0|-4.4|2.4||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for subject within the sequence.|ANCOVA|||||2.4|-4.4|0.5233
71144860|NCT02960217|141783130|SUPERIORITY|||||||0.6918|||||||Wilk-Shapiro Test for Normality|||||||0.6918
71144861|NCT00214045|141783131|SUPERIORITY_OR_OTHER|Results were analyzed using Wilcoxon rank sums and Fisher exact tests with Statistical Analysis System (SAS) statistical software version 9.||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||.39
71144862|NCT00214045|141783131|NON_INFERIORITY_OR_EQUIVALENCE|Results were analyzed using Wilcoxon rank sums and Fisher exact tests with Statistical Analysis System (SAS) statistical software version 9.||||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.37
71144863|NCT01766050|141783146|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.991|||||TWO_SIDED|90.0|0.898|1.093||||||||1.093|0.898|
71144864|NCT01766050|141783146|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.911|||||TWO_SIDED|90.0|0.83|1.0||||||||1.000|0.830|
71144865|NCT01766050|141783146|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.994|||||TWO_SIDED|90.0|0.885|1.116||||||||1.116|0.885|
71144866|NCT01766050|141783164|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.05|||||TWO_SIDED|90.0|0.976|1.13||||||AUC (0-T)||1.130|0.976|
70870049|NCT01001377|141225619|SUPERIORITY_OR_OTHER_LEGACY||Stratified Cox proportional hazard ratio|0.966|||||TWO_SIDED|95.0|0.839|1.113|||||Hazard ratio is presented as panitumumab : cetuximab. A value \< 1.0 indicates a lower average event rate and longer time to event for panitumumab relative to cetuximab.|Cox proportional hazards model stratified by geographic region (North America, western Europe and Australia vs rest of world) and ECOG performance status (0 or 1 vs 2).||1.113|0.839|
71144867|NCT01766050|141783164|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.966|||||TWO_SIDED|90.0|0.889|1.049||||||AUC (0-T)||1.049|0.889|
70870050|NCT01001377|141225619|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The overall survival non-inferiority hypothesis based on an asymptotic normal score was tested at a 1-sided 2.5% significance level. A value \< -1.96 indicates non-inferiority at a significance level of 1-sided 0.025.|Normal score|-3.19||||0.0007||||||A synthesis approach with an asymptotic standard normal test statistic|Asymptotic standard normal test|||A synthesis approach with an asymptotic standard normal test statistic based on the logarithm of the hazard ratio was used to test the hypothesis that panitumumab is non-inferior to cetuximab for overall survival (ie, that panitumumab retains at least 50% of the overall survival benefit of cetuximab relative to best supportive care).||||0.0007
70870051|NCT01001377|141225621|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.83|1.58|||||Common treatment odds ratio stratified by geographic region (North America, western Europe and Australia vs rest of world) and ECOG performance status (0 or 1 vs 2).|||1.58|0.83|
70870052|NCT01001377|141225625|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0126|||||TWO_SIDED|95.0|-0.0353|0.0605|||||A positive difference between the treatment groups favors the panitumumab group.|Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.||0.0605|-0.0353|
71144868|NCT01766050|141783164|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.033|||||TWO_SIDED|90.0|0.95|1.123||||||AUC (0-T)||1.123|0.950|
71144869|NCT01766050|141783164|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.049|||||TWO_SIDED|90.0|0.975|1.127||||||AUC (INF)||1.127|0.975|
71144870|NCT01766050|141783164|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.968|||||TWO_SIDED|90.0|0.892|1.049||||||AUC (INF)||1.049|0.892|
71144871|NCT01766050|141783164|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.031|||||TWO_SIDED|90.0|0.948|1.121||||||AUC(INF)||1.121|0.948|
71144872|NCT01766050|141783165|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.991|||||TWO_SIDED|90.0|0.898|1.093||||||||1.093|0.898|
71144873|NCT01766050|141783165|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.911|||||TWO_SIDED|90.0|0.83|1.0||||||||1.000|0.830|
71144874|NCT01766050|141783165|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.994|||||TWO_SIDED|90.0|0.885|1.116||||||||1.116|0.885|
71144875|NCT01766050|141783166|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.013|||||TWO_SIDED|90.0|0.944|1.088||||||AUC (0-T)||1.088|0.944|
71144876|NCT01766050|141783166|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.016|||||TWO_SIDED|90.0|0.936|1.103||||||AUC (0-T)||1.103|0.936|
71144877|NCT01766050|141783166|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.001|||||TWO_SIDED|90.0|0.893|1.121||||||AUC (0-T)||1.121|0.893|
71144878|NCT01766050|141783166|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.011|||||TWO_SIDED|90.0|0.942|1.085||||||AUC (INF)||1.085|0.942|
71144879|NCT01766050|141783166|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.016|||||TWO_SIDED|90.0|0.938|1.101||||||AUC (INF)||1.101|0.938|
71144880|NCT01766050|141783166|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.002|||||TWO_SIDED|90.0|0.896|1.121||||||AUC (INF)||1.121|0.896|
71144881|NCT01766050|141783167|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.26|||||TWO_SIDED|90.0|1.118|1.421||||||||1.421|1.118|
71144882|NCT01766050|141783167|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.292|||||TWO_SIDED|90.0|1.09|1.531||||||||1.531|1.090|
71144883|NCT01766050|141783167|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.178|||||TWO_SIDED|90.0|0.971|1.429||||||||1.429|0.971|
71144884|NCT01766050|141783168|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.159|||||TWO_SIDED|90.0|1.056|1.272||||||AUC (0-T)||1.272|1.056|
71144885|NCT01766050|141783168|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.228|||||TWO_SIDED|90.0|1.092|1.381||||||AUC (0-T)||1.381|1.092|
71144886|NCT01766050|141783168|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.215|||||TWO_SIDED|90.0|1.047|1.41||||||AUC (0-T)||1.410|1.047|
71144887|NCT01766050|141783168|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.193|||||TWO_SIDED|90.0|1.091|1.304||||||AUC (INF)||1.304|1.091|
71144888|NCT01766050|141783168|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.227|||||TWO_SIDED|90.0|1.093|1.379||||||AUC (INF)||1.379|1.093|
71144889|NCT01766050|141783168|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.3|||||TWO_SIDED|90.0|1.141|1.482||||||AUC (INF)||1.482|1.141|
71144890|NCT01766050|141783169|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.863|||||TWO_SIDED|90.0|0.746|0.997||||||||0.997|0.746|
71144891|NCT01766050|141783169|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.922|||||TWO_SIDED|90.0|0.793|1.071||||||||1.071|0.793|
71144892|NCT01766050|141783169|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.856|||||TWO_SIDED|90.0|0.709|1.034||||||||1.034|0.709|
71144893|NCT01766050|141783170|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.915|||||TWO_SIDED|90.0|0.817|1.024||||||AUC (0-T)||1.024|0.817|
71144894|NCT01766050|141783170|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.003|||||TWO_SIDED|90.0|0.856|1.175||||||AUC (0-T)||1.175|0.856|
71144895|NCT01766050|141783170|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.963|||||TWO_SIDED|90.0|0.821|1.13||||||AUC (0-T)||1.130|0.821|
71144896|NCT01766050|141783170|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.877|||||TWO_SIDED|90.0|0.783|0.982||||||AUC (INF)||0.982|0.783|
71144897|NCT01766050|141783170|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.031|||||TWO_SIDED|90.0|0.885|1.2||||||AUC (INF)||1.200|0.885|
71144898|NCT01766050|141783170|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.022|||||TWO_SIDED|90.0|0.839|1.245||||||AUC (INF)||1.245|0.839|
71144899|NCT01766050|141783171|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.948|||||TWO_SIDED|90.0|0.88|1.021||||||||1.021|0.880|
71144900|NCT01766050|141783171|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.922|||||TWO_SIDED|90.0|0.857|0.993||||||||0.993|0.857|
71144901|NCT01766050|141783171|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.954|||||TWO_SIDED|90.0|0.885|1.028||||||||1.028|0.885|
71144902|NCT01766050|141783172|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.941|||||TWO_SIDED|90.0|0.874|1.013||||||AUC (0-T)||1.013|0.874|
71144903|NCT01766050|141783172|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.986|||||TWO_SIDED|90.0|0.902|1.076||||||AUC (0-T)||1.076|0.902|
70870053|NCT01001377|141225626|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.6745|||||TWO_SIDED|95.0|-4.9331|1.5841|||||A positive difference between the treatment groups favors the panitumumab group.|Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.||1.5841|-4.9331|
70870054|NCT01001377|141225627|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.0372|||||TWO_SIDED|95.0|-2.3267|4.401|||||A positive difference between the treatment groups favors the panitumumab group.|Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.||4.4010|-2.3267|
70870055|NCT01001377|141225628|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.5836|||||TWO_SIDED|95.0|-3.0269|4.1941|||||A positive difference between the treatment groups favors the panitumumab group.|Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.||4.1941|-3.0269|
70870056|NCT01001377|141225629|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1998|||||TWO_SIDED|95.0|-6.0093|5.6098|||||A positive difference between the treatment groups favors the panitumumab group.|Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.||5.6098|-6.0093|
70870057|NCT03600818|141225654|SUPERIORITY||Difference in percentage|18.0|||=|0.0193|TWO_SIDED|95.0|4.15|31.82||Threshold for significance at 0.05 level.|Fisher Exact|||||31.82|4.15|=0.0193
70870058|NCT03600818|141225655|SUPERIORITY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Wilcoxon rank-sum test|||A hierarchical testing procedure was used to control the overall type I error. If the primary endpoint reaches statistical significance then the secondary endpoint for total cumulative CS dose was tested next.||||<0.0001
70870059|NCT03416946|141225677|SUPERIORITY|||||||0.79||||||Post-op HKA angle|t-test, 2 sided|||||||0.790
70870060|NCT01112865|141225728|SUPERIORITY_OR_OTHER|||||||0.6858|TWO_SIDED|||||Binomial test against the null hypothesis|binomial test|||Null hypothesis: percentage of participants preferring Genotropin Mark VII injection pen = 50%||||0.6858
70870061|NCT00740831|141225731|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority analysis based on the use of one-sided confidence intervals, using 2.5% level of statistical significance.|Difference in proportions|1.2|||||ONE_SIDED|97.5|-9.3||||||Newcombe-Wilson method for CI. Percentage in A minus percentage in C needed to be greater than non-inferiority margin of -20%.|As comparison involved two doses of PGL4001 vs GnRH-agonist, Bonferroni correction used to adjust confidence intervals.|||-9.3|
70870062|NCT00740831|141225731|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority analysis based on the use of one-sided confidence intervals, using 2.5% level of statistical significance.|Difference in proportions|8.8|||||ONE_SIDED|97.5|0.4||||||Newcombe-Wilson method for CI. Percentage in B minus percentage in C needed to be greater than non-inferiority margin of -20%.|As comparison involved two doses of PGL4001 vs GnRH-agonist, Bonferroni correction used to adjust confidence intervals.|||0.4|
70870063|NCT00740831|141225732|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Mean Difference (Final Values)|0.089|||||TWO_SIDED|95.0|-0.003|0.181||No p-values generated|ANCOVA|Analysis of covariance after log transformation of the data|As comparison of 2 doses of PGL4001 vs GnRH-agonist, Bonneferroni correction used to adjust confidence intervals|||0.181|-0.003|
70870064|NCT00740831|141225732|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Mean Difference (Final Values)|0.049|||||TWO_SIDED|95.0|-0.043|0.14||No p-values generated|ANCOVA|Analysis of covariance after log transformation of the data|As comparison of 2 doses of PGL4001 vs GnRH-agonist, Bonneferroni correction used to adjust confidence intervals|||0.14|-0.043|
70870065|NCT00740831|141225733|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.3|||<|0.001|TWO_SIDED|95.0|-40.6|-14.6||Since comparisons of 2 doses of ulipristal acetate vs GnRH-agonist, Bonferroni correction was used, p values were doubled (p-value threshold was 0.05) and CI adjusted|Cochran-Mantel-Haenszel|Analysed via Cochran-Mantel-Haenszel test, controlling for strata||||-14.6|-40.6|<0.001
70870066|NCT00740831|141225733|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.9|||<|0.001|TWO_SIDED|95.0|-42.0|-16.6||Since comparisons of 2 doses of ulipristal acetate vs GnRH-agonist, Bonferroni correction was used, p values were doubled (p-value threshold was 0.05) and CI adjusted|Cochran-Mantel-Haenszel|Analysed via Cochran-Mantel-Haenszel test, controlling for strata||||-16.6|-42.0|<0.001
70870067|NCT00740831|141225734|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.3|||<|0.001|TWO_SIDED|95.0|-40.6|-14.6||Since planned analyses involved comparisons of 2 doses of PGL4001 vs GnRH-agonist, a Bonferroni correction was used and p values were doubled (p-value threshold was 0.05) and confidence intervals were similarly adjusted|Cochran-Mantel-Haenszel|Analysed via a Cochran-Mantel-Haenszel test, controlling for strata||||-14.6|-40.6|<0.001
70870068|NCT00740831|141225734|SUPERIORITY_OR_OTHER||Median Difference (Net)|-29.9|||<|0.001|TWO_SIDED|95.0|-42.0|-16.6||Since planned analyses involved comparisons of 2 doses of PGL4001 vs GnRH-agonist, a Bonferroni correction was used and p values were doubled (p-value threshold was 0.05) and confidence intervals were similarly adjusted|Cochran-Mantel-Haenszel|Analysed via a Cochran-Mantel-Haenszel test, controlling for strata||||-16.6|-42.0|<0.001
70870069|NCT03982368|141225740|SUPERIORITY||least square mean difference|0.93||||0.078|TWO_SIDED|95.0|-1.47|3.32|||ANOVA|||The primary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.||3.32|-1.47|0.078
70870070|NCT03982368|141225740|SUPERIORITY||least square mean difference|2.31||||0.066|TWO_SIDED|95.0|-0.08|4.7|||ANOVA|||The primary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.||4.70|-0.08|0.066
70870071|NCT03982368|141225741|SUPERIORITY||Least square mean difference|1.71||||0.032|TWO_SIDED|95.0|-0.7|4.12|||ANOVA|||||4.12|-0.70|0.032
70870072|NCT03982368|141225741|SUPERIORITY||Least square mean difference|2.44||||0.029|TWO_SIDED|95.0|0.02|4.86|||ANOVA|||||4.86|0.02|0.029
70870073|NCT03982368|141225742|SUPERIORITY|||||||0.534|||||||t-test, 2 sided|||||||0.534
70870074|NCT03982368|141225742|SUPERIORITY|||||||0.611|||||||t-test, 2 sided|||||||0.611
70870075|NCT03982368|141225743|SUPERIORITY|||||||0.486|||||||t-test, 2 sided|||||||0.486
70952725|NCT03921723|141407160|EQUIVALENCE|Bioequivalence is established when the 90% confidence interval of the ratio for AUC (0 to inf) between treatment formulations (Prototype A versus DTG Reference Treatment) are within the range of 0.80 to 1.25|Ratio|0.96|||||TWO_SIDED|90.0|0.91|1.03||||||||1.03|0.91|
70952726|NCT03921723|141407160|EQUIVALENCE|Bioequivalence is established when the 90% confidence interval of the ratio for AUC (0 to inf) between treatment formulations (Prototype B versus DTG Reference Treatment) are within the range of 0.80 to 1.25|Ratio|1.13||||||90.0|1.06|1.2||||||||1.20|1.06|
71144904|NCT01766050|141783172|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.027|||||TWO_SIDED|90.0|0.942|1.12||||||AUC (0-T)||1.120|0.942|
71144905|NCT01766050|141783172|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.939|||||TWO_SIDED|90.0|0.868|1.017||||||AUC (INF)||1.017|0.868|
71144906|NCT01766050|141783172|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.002|||||TWO_SIDED|90.0|0.914|1.098||||||||1.098|0.914|
71144907|NCT01766050|141783172|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.036|||||TWO_SIDED|90.0|0.94|1.142||||||AUC (INF)||1.142|0.940|
71144908|NCT03577275|141783182|OTHER|||||||||||||||||"The primary analysis was based on concentration-QTc modeling of the relationship between icosabutate and delta delta QTcF, with the intent to exclude an effect \> 10 msec at clinically relevant icosabutate plasma concentrations.~Assay sensitivity was evaluated by concentration-QTc analysis of the effect on delta delta QTcF of moxifloxacin using a similar model as for the primary analysis."|The primary analysis was based on concentration-QTc modeling of the relationship between icosabutate and delta delta QTcF, with the intent to exclude an effect \> 10 msec at clinically relevant icosabutate plasma concentrations.|||
71144909|NCT03270436|141783213|SUPERIORITY|||||||0.3599||||||The p-value above reflects results of between-arms analysis of change in mean weight from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.3599
71144910|NCT03270436|141783213|SUPERIORITY|||||||0.3207||||||The p-value above reflects results of between-arms analysis of change in mean weight from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.3207
71144911|NCT03270436|141783214|SUPERIORITY|||||||0.5698||||||The p-value above reflects results of between-arms analysis of mean change in HbA1c from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.5698
70952727|NCT03921723|141407161|EQUIVALENCE|Bioequivalence is established when the 90% confidence interval of the ratio for Cmax between treatment formulations (Prototype A versus DTG Reference Treatment) are within the range of 0.80 to 1.25|Ratio|1.09|||||TWO_SIDED|90.0|1.01|1.19||||||||1.19|1.01|
71144912|NCT03270436|141783214|SUPERIORITY|||||||0.4106||||||The p-value above reflects results of between-arms analysis of mean change in HbA1c from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.4106
71144913|NCT03270436|141783215|SUPERIORITY|||||||0.0293||||||The p-value above reflects results of between-arms analysis of mean change in systolic blood pressure from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.0293
71144914|NCT03270436|141783215|SUPERIORITY|||||||0.4686||||||The p-value above reflects results of between-arms analysis of mean change in systolic blood pressure from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.4686
71144915|NCT03270436|141783216|SUPERIORITY|||||||0.0068||||||The p-value above reflects results of between-arms analysis of mean change in diastolic blood pressure from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.0068
71144916|NCT03270436|141783216|SUPERIORITY|||||||0.9181||||||The p-value above reflects results of between-arms analysis of mean change in diastolic blood pressure from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.9181
71144917|NCT03270436|141783217|SUPERIORITY|||||||0.5984||||||The p-value above reflects results of between-arms analysis of mean change in sugar-sweetened beverages consumed per day from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.5984
71144918|NCT03270436|141783217|SUPERIORITY|||||||0.3376||||||The p-value above reflects results of between-arms analysis of mean change in sugar-sweetened beverages consumed per day from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.3376
70870076|NCT03982368|141225743|SUPERIORITY|||||||0.564|||||||t-test, 2 sided|||||||0.564
70952728|NCT03921723|141407161|EQUIVALENCE|Bioequivalence is established when the 90% confidence interval of the ratio for Cmax between treatment formulations (Prototype B versus DTG Reference Treatment) are within the range of 0.80 to 1.25|Ratio|1.22|||||TWO_SIDED|90.0|1.13|1.33||||||||1.33|1.13|
70952729|NCT02683785|141407171|OTHER||Mean Difference (Net)|-0.36||||0.442|TWO_SIDED|95.0|-1.31|0.58||MMRM model with fixed effects of Baseline Value,Treatment Group,Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used.p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 6 is presented.|||0.58|-1.31|0.442
70952730|NCT02683785|141407172|OTHER||Mean Difference (Net)|-0.46||||0.046|TWO_SIDED|95.0|-0.9|-0.01||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 1 is presented|||-0.01|-0.90|0.046
70952731|NCT02683785|141407172|OTHER||Mean Difference (Net)|-0.38||||0.257|TWO_SIDED|95.0|-1.05|0.29||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented|||0.29|-1.05|0.257
70952732|NCT02683785|141407172|OTHER||Mean Difference (Net)|-0.5||||0.22|TWO_SIDED|95.0|-1.31|0.31||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 3 is presented|||0.31|-1.31|0.220
70952733|NCT02683785|141407172|OTHER||Mean Difference (Net)|-0.74||||0.085|TWO_SIDED|95.0|-1.59|0.11||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented|||0.11|-1.59|0.085
70952734|NCT02683785|141407172|OTHER||Mean Difference (Net)|-0.36||||0.442|TWO_SIDED|95.0|-1.31|0.58||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 6 is presented|||0.58|-1.31|0.442
70952735|NCT02683785|141407172|OTHER||Mean Difference (Net)|-0.83||||0.139|TWO_SIDED|95.0|-1.93|0.28||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented|||0.28|-1.93|0.139
71144919|NCT03270436|141783218|SUPERIORITY|||||||0.296||||||The p-value above reflects results of between-arms analysis of mean change in fruit \& vegetable consumption scores from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.2960
71144920|NCT03270436|141783218|SUPERIORITY|||||||0.1519||||||The p-value above reflects results of between-arms analysis of mean change in fruit \& vegetable consumption scores from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.1519
70952736|NCT02683785|141407172|OTHER||Mean Difference (Net)|-0.9||||0.103|TWO_SIDED|95.0|-2.0|0.19||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 10 is presented|||0.19|-2.00|0.103
70952737|NCT02683785|141407172|OTHER||Mean Difference (Net)|-0.89||||0.132|TWO_SIDED|95.0|-2.06|0.28||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented.|||0.28|-2.06|0.132
70952738|NCT02683785|141407173|OTHER||Mean Difference (Net)|-0.45||||0.082|TWO_SIDED|95.0|-0.97|0.06||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 1 is presented.|||0.06|-0.97|0.082
70952739|NCT02683785|141407173|OTHER||Mean Difference (Net)|-0.27||||0.426|TWO_SIDED|95.0|-0.96|0.41||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented|||0.41|-0.96|0.426
70952740|NCT02683785|141407173|OTHER||Mean Difference (Net)|-0.6||||0.129|TWO_SIDED|95.0|-1.38|0.18||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 3 is presented|||0.18|-1.38|0.129
71144921|NCT03270436|141783219|SUPERIORITY|||||||0.2824||||||The p-value above reflects results of between-arms analysis of change from baseline to immediate post-intervention. Analyses do not include imputed values.|Mantel Haenszel|The model includes only the study arm and time interaction.||Adjusted repeated measures generalized estimating equations (GEE) model.||||0.2824
70870077|NCT03982368|141225745|SUPERIORITY|||||||0.81|||||||t-test, 2 sided|||||||0.810
70870078|NCT03982368|141225745|SUPERIORITY|||||||0.733|||||||t-test, 2 sided|||||||0.733
70870079|NCT03982368|141225746|SUPERIORITY||Least square mean difference|1.97||||0.025|TWO_SIDED|95.0|-0.19|4.13|||ANOVA|||The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.||4.13|-0.19|0.025
70870080|NCT03982368|141225746|SUPERIORITY||Least square mean difference|0.68||||0.243|TWO_SIDED|95.0|-1.48|2.83|||ANOVA|||The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.||2.83|-1.48|0.243
70870081|NCT03982368|141225747|SUPERIORITY||Least square mean difference|2.41||||0.007|TWO_SIDED|95.0|0.28|4.54|||ANOVA|||||4.54|0.28|0.007
70870082|NCT03982368|141225747|SUPERIORITY||Least square mean difference|0.71||||0.23|TWO_SIDED|95.0|-1.43|2.85|||ANOVA|||||2.85|-1.43|0.230
70870083|NCT03982368|141225748|SUPERIORITY||Least square mean difference|-1.16||||0.799|TWO_SIDED|95.0|-3.11|0.8|||ANOVA|Last Observation Carried Forward (LOCF) was used for imputing missing data in the Full analysis set at Week 4.||"The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.~p value for total corneal ancd conjunctival score is reported."||0.80|-3.11|0.799
70870084|NCT03982368|141225748|SUPERIORITY||Least square mean difference|-0.36||||0.715|TWO_SIDED|95.0|-2.3|1.59|||ANOVA|||The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.||1.59|-2.30|0.715
70870085|NCT03982368|141225749|SUPERIORITY||Least square mean difference|-1.54||||0.831|TWO_SIDED|95.0|-3.4|0.31|||ANOVA|||"The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.~p value for total corneal ancd conjunctival score is reported."||0.31|-3.40|0.831
70870086|NCT03982368|141225749|SUPERIORITY||Least square mean difference|-0.21||||0.75|TWO_SIDED|95.0|-2.07|1.66|||ANOVA|||"The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.~p value for total corneal ancd conjunctival score is reported."||1.66|-2.07|0.750
70870087|NCT03982368|141225750|SUPERIORITY||Least square mean difference|0.96||||0.004|TWO_SIDED|95.0|0.17|1.75|||ANOVA|||||1.75|0.17|0.004
70870088|NCT03982368|141225750|SUPERIORITY||Least square mean difference|0.28||||0.217|TWO_SIDED|95.0|-0.51|1.07|||ANOVA|||||1.07|-0.51|0.217
71144922|NCT03270436|141783219|SUPERIORITY|||||||0.7547||||||The p-value above reflects results of between-arms analysis of change from baseline to 6 months post-intervention. Analyses do not include imputed values.|Mantel Haenszel|The model includes only the study arm and time interaction.||Adjusted repeated measures generalized estimating equations (GEE) model.||||0.7547
70870089|NCT03982368|141225751|SUPERIORITY||Least square mean difference|0.92||||0.007|TWO_SIDED|95.0|0.1|1.74|||ANOVA|||||1.74|0.10|0.007
70870090|NCT03982368|141225751|SUPERIORITY||Least square mean difference|0.28||||0.225|TWO_SIDED|95.0|-0.54|1.1|||ANOVA|||||1.10|-0.54|0.225
70870091|NCT03982368|141225752|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||0.680
70870092|NCT03982368|141225752|SUPERIORITY|||||||0.066|||||||t-test, 2 sided|||||||0.066
70870093|NCT03982368|141225753|SUPERIORITY|||||||0.097|||||||Chi-squared|||||||0.097
70870094|NCT03982368|141225753|SUPERIORITY|||||||0.076|||||||Chi-squared|||||||0.076
70870095|NCT03982368|141225754|SUPERIORITY||Least square mean difference|16.4||||0.289|TWO_SIDED|95.0|12.0|20.8|||ANOVA|||Daily Activity Limitations - change from baseline to week 4||20.8|12.0|0.289
70870096|NCT03982368|141225754|SUPERIORITY||Least square mean difference|19.7||||0.032|TWO_SIDED|95.0|15.4|24.0|||ANOVA|||Daily Activity Limitations - change from baseline to week 4||24.0|15.4|0.032
70870097|NCT03982368|141225754|SUPERIORITY||Least square mean difference|16.4||||0.095|TWO_SIDED|95.0|11.9|20.8|||ANOVA|||Daily Activity Limitations - change to baseline to week 8||20.8|11.9|0.095
70870098|NCT03982368|141225754|SUPERIORITY||Least square mean difference|14.5||||0.282|TWO_SIDED|95.0|10.1|18.8|||ANOVA|||Daily Activity Limitations - change from baseline to week 8||18.8|10.1|0.282
70870099|NCT03982368|141225754|SUPERIORITY||Least square mean difference|15.0||||0.169|TWO_SIDED|95.0|10.6|19.4|||ANOVA|||Daily Activity Limitations - change from baseline to week 12||19.4|10.6|0.169
70870100|NCT03982368|141225754|SUPERIORITY||Least square mean difference|15.4||||0.129|TWO_SIDED|95.0|11.1|19.7|||ANOVA|||Daily Activity Limitations - change from baseline to week 12||19.7|11.1|0.129
70870101|NCT03982368|141225754|SUPERIORITY||Least square mean difference|14.0||||0.111|TWO_SIDED|95.0|9.7|18.4|||ANOVA|||Daily Activity Limitations - change from baseline to week 16||18.4|9.7|0.111
70870102|NCT03982368|141225754|SUPERIORITY||Least square mean difference|14.0||||0.107|TWO_SIDED|95.0|9.7|18.3|||ANOVA|||Daily Activity Limitations - change from baseline to week 16||18.3|9.7|0.107
70870103|NCT03982368|141225754|SUPERIORITY||Least square mean difference|14.3||||0.827|TWO_SIDED|95.0|9.7|18.9|||ANOVA|||Emotional Well-Being - change from baseline to week 4||18.9|9.7|0.827
70870104|NCT03982368|141225754|SUPERIORITY||Least square mean difference|16.3||||0.688|TWO_SIDED|95.0|11.8|20.8|||ANOVA|||Emotional Well-Being - change from baseline to week 4||20.8|11.8|0.688
70870105|NCT03982368|141225754|SUPERIORITY||Least square mean difference|15.7||||0.324|TWO_SIDED|95.0|11.4|20.0|||ANOVA|||Emotional Well-Being - change from baseline to week 8||20.0|11.4|0.324
70870106|NCT03982368|141225754|SUPERIORITY||Least square mean difference|12.9||||0.949|TWO_SIDED|95.0|8.7|17.1|||ANOVA|||Emotional Well-Being - change from baseline to week 8||17.1|8.7|0.949
70870107|NCT03982368|141225754|SUPERIORITY||Least square mean difference|15.7||||0.927|TWO_SIDED|95.0|11.4|20.1|||ANOVA|||Emotional Well-Being - change from baseline to week 12||20.1|11.4|0.927
70870108|NCT03982368|141225754|SUPERIORITY||Least square mean difference|14.8||||0.776|TWO_SIDED|95.0|10.8|18.8|||ANOVA|||Emotional Well-Being - change from baseline to week 12||18.8|10.8|0.776
70870109|NCT03982368|141225754|SUPERIORITY||Least square mean difference|15.7||||0.418|TWO_SIDED|95.0|11.4|20.1|||ANOVA|||Emotional Well-Being - change from baseline to week 16||20.1|11.4|0.418
70870110|NCT03982368|141225754|SUPERIORITY||Least square mean difference|14.8||||0.613|TWO_SIDED|95.0|10.6|19.0|||ANOVA|||Emotional Well-Being - change from baseline to week 16||19.0|10.6|0.613
70870111|NCT03982368|141225754|SUPERIORITY||Least square mean difference|15.8||||0.721|TWO_SIDED|95.0|8.3|23.2|||ANOVA|||Work Limitations - change from baseline to week 4||23.2|8.3|0.721
70952741|NCT02683785|141407173|OTHER||Mean Difference (Net)|-0.78||||0.067|TWO_SIDED|95.0|-1.63|0.06||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented.|||0.06|-1.63|0.067
70952742|NCT02683785|141407173|OTHER||Mean Difference (Net)|-0.33||||0.494|TWO_SIDED|95.0|-1.28|0.63||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 6 is presented|||0.63|-1.28|0.494
70952743|NCT02683785|141407173|OTHER||Mean Difference (Net)|-0.94||||0.107|TWO_SIDED|95.0|-2.08|0.21||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented.|||0.21|-2.08|0.107
70952744|NCT02683785|141407173|OTHER||Mean Difference (Net)|-0.98||||0.092|TWO_SIDED|95.0|-2.13|0.17||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 10 is presented.|||0.17|-2.13|0.092
70952745|NCT02683785|141407173|OTHER||Mean Difference (Net)|-1.01||||0.098|TWO_SIDED|95.0|-2.22|0.2||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented.|||0.20|-2.22|0.098
70952746|NCT02683785|141407178|OTHER||Mean Difference (Net)|-2.8||||0.061|TWO_SIDED|95.0|-5.6|0.1||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component, Week 1|||0.1|-5.6|0.061
70952747|NCT02683785|141407178|OTHER||Mean Difference (Net)|-2.0||||0.282|TWO_SIDED|95.0|-5.6|1.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Pain component, Week 2|||1.7|-5.6|0.282
70952748|NCT02683785|141407178|OTHER||Mean Difference (Net)|-3.7||||0.113|TWO_SIDED|95.0|-8.4|0.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component Week 4|||0.9|-8.4|0.113
70952749|NCT02683785|141407178|OTHER||Mean Difference (Net)|-1.0||||0.695|TWO_SIDED|95.0|-5.9|4.0||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component, Week 6|||4.0|-5.9|0.695
70952750|NCT02683785|141407178|OTHER||Mean Difference (Net)|-3.8||||0.176|TWO_SIDED|95.0|-9.4|1.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component, Week 8|||1.8|-9.4|0.176
70952751|NCT02683785|141407178|OTHER||Mean Difference (Net)|-5.5||||0.041|TWO_SIDED|95.0|-10.8|-0.2||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component, Week 10|||-0.2|-10.8|0.041
70952752|NCT02683785|141407178|OTHER||Mean Difference (Net)|-4.7||||0.082|TWO_SIDED|95.0|-10.1|0.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component, Week 12|||0.6|-10.1|0.082
70952753|NCT02683785|141407178|OTHER||Mean Difference (Net)|-0.2||||0.587|TWO_SIDED|95.0|-1.1|0.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 1|||0.6|-1.1|0.587
70952754|NCT02683785|141407178|OTHER||Mean Difference (Net)|-0.4||||0.457|TWO_SIDED|95.0|-1.3|0.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 2|||0.6|-1.3|0.457
70952755|NCT02683785|141407178|OTHER||Mean Difference (Net)|-0.6||||0.298|TWO_SIDED|95.0|-1.8|0.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 4|||0.6|-1.8|0.298
70952756|NCT02683785|141407178|OTHER||Mean Difference (Net)|-0.2||||0.726|TWO_SIDED|95.0|-1.3|0.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 6|||0.9|-1.3|0.726
70952757|NCT02683785|141407178|OTHER||Mean Difference (Net)|-0.7||||0.213|TWO_SIDED|95.0|-1.9|0.4||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 8|||0.4|-1.9|0.213
70870112|NCT03982368|141225754|SUPERIORITY||Least square mean difference|20.6||||0.558|TWO_SIDED|95.0|13.1|28.0|||ANOVA|||Work Limitations - change from baseline to week 4||28.0|13.1|0.558
70870113|NCT03982368|141225754|SUPERIORITY||Least square mean difference|18.4||||0.809|TWO_SIDED|95.0|11.5|25.3|||ANOVA|||Work Limitations - change from baseline to week 8||25.3|11.5|0.809
70870114|NCT03982368|141225754|SUPERIORITY||Least square mean difference|19.4||||0.651|TWO_SIDED|95.0|12.4|26.4|||ANOVA|||Work Limitations - change from baseline to week 8||26.4|12.4|0.651
70870115|NCT03982368|141225754|SUPERIORITY||Least square mean difference|16.4||||0.769|TWO_SIDED|95.0|9.5|23.3|||ANOVA|||Work Limitations - change from baseline to week 12||23.3|9.5|0.769
70870116|NCT03982368|141225754|SUPERIORITY||Least square mean difference|21.3||||0.454|TWO_SIDED|95.0|14.3|28.3|||ANOVA|||Work Limitations - change from baseline to week 12||28.3|14.3|0.454
70870117|NCT03982368|141225754|SUPERIORITY||Least square mean difference|18.3||||0.564|TWO_SIDED|95.0|11.6|25.0|||ANOVA|||Work Limitations - change from baseline to week 16||25.0|11.6|0.564
70870118|NCT03982368|141225754|SUPERIORITY||Least square mean difference|21.0||||0.25|TWO_SIDED|95.0|14.1|27.8|||ANOVA|||Work Limitations - change from baseline to week 16||27.8|14.1|0.250
70870119|NCT03982368|141225754|SUPERIORITY||Least square mean difference|23.9||||0.853|TWO_SIDED|95.0|15.6|32.2|||ANOVA|||Treatment Satisfaction - change from baseline to week 4||32.2|15.6|0.853
70870120|NCT03982368|141225754|SUPERIORITY||Least square mean difference|20.0||||0.393|TWO_SIDED|95.0|11.9|28.0|||ANOVA|||Treatment Satisfaction - change from baseline to week 4||28.0|11.9|0.393
70870121|NCT03982368|141225754|SUPERIORITY||Least square mean difference|27.9||||0.01|TWO_SIDED|95.0|20.2|35.6|||ANOVA|||Treatment Satisfaction - change from baseline to week 8||35.6|20.2|0.010
70870122|NCT03982368|141225754|SUPERIORITY||Least square mean difference|18.3||||0.395|TWO_SIDED|95.0|11.1|25.4|||ANOVA|||Treatment Satisfaction - change from baseline to week 8||25.4|11.1|0.395
70870123|NCT03982368|141225754|SUPERIORITY||Least square mean difference|24.8||||0.068|TWO_SIDED|95.0|17.1|32.4|||ANOVA|||Treatment Satisfaction - change from baseline to week 12||32.4|17.1|0.068
70870124|NCT03982368|141225754|SUPERIORITY||Least square mean difference|19.3||||0.4|TWO_SIDED|95.0|12.2|26.4|||ANOVA|||Treatment Satisfaction - change from baseline to week 12||26.4|12.2|0.400
70870125|NCT03982368|141225754|SUPERIORITY||Least square mean difference|25.5||||0.021|TWO_SIDED|95.0|18.1|33.0|||ANOVA|||Treatment Satisfaction - change from baseline to week 16||33.0|18.1|0.021
70870126|NCT03982368|141225754|SUPERIORITY||Least square mean difference|23.1||||0.056|TWO_SIDED|95.0|16.1|30.0|||ANOVA|||Treatment Satisfaction - change from baseline to week 16||30.0|16.1|0.056
70870127|NCT03982368|141225754|SUPERIORITY||Least square mean difference|14.2||||0.981|TWO_SIDED|95.0|7.6|20.7|||ANOVA|||Treatment-Related Bother - change from baseline to week 4||20.7|7.6|0.981
70870128|NCT03982368|141225754|SUPERIORITY||Least square mean difference|17.0||||0.525|TWO_SIDED|95.0|11.1|22.9|||ANOVA|||Treatment-Related Bother - change from baseline to week 4||22.9|11.1|0.525
70870129|NCT03982368|141225754|SUPERIORITY||Least square mean difference|9.5||||0.356|TWO_SIDED|95.0|2.9|16.0|||ANOVA|||Treatment-Related Bother - change from baseline to week 8||16.0|2.9|0.356
70870130|NCT03982368|141225754|SUPERIORITY||Least square mean difference|6.5||||0.771|TWO_SIDED|95.0|0.7|12.4|||ANOVA|||Treatment-Related Bother - change from baseline to week 8||12.4|0.7|0.771
70870131|NCT03982368|141225754|SUPERIORITY||Least square mean difference|8.7||||0.926|TWO_SIDED|95.0|2.0|15.5|||ANOVA|||Treatment-Related Bother - change from baseline to week 12||15.5|2.0|0.926
70870132|NCT03982368|141225754|SUPERIORITY||Least square mean difference|7.9||||0.778|TWO_SIDED|95.0|1.9|13.9|||ANOVA|||Treatment-Related Bother - change from baseline to week 12||13.9|1.9|0.778
70870133|NCT03982368|141225754|SUPERIORITY||Least square mean difference|10.0||||0.984|TWO_SIDED||||||ANOVA|||Treatment-Related Bother - change from baseline to week 16||||0.984
70870134|NCT03982368|141225754|SUPERIORITY||Least square mean difference|7.4||||0.514|TWO_SIDED|95.0|1.6|13.1|||ANOVA|||Treatment-Related Bother - change from baseline to week 16||13.1|1.6|0.514
70870135|NCT03982368|141225754|SUPERIORITY||Least square mean difference|-16.6||||0.985|TWO_SIDED|95.0|-20.4|-12.8|||ANOVA|||Symptom Bother - change from baseline to week 4||-12.8|-20.4|0.985
70870136|NCT03982368|141225754|SUPERIORITY||Least square mean difference|-17.8||||0.646|TWO_SIDED|95.0|-21.5|-14.0|||ANOVA|||Symptom Bother - change from baseline to week 4||-14.0|-21.5|0.646
70870137|NCT03982368|141225754|SUPERIORITY||Least square mean difference|-20.7||||0.007|TWO_SIDED|95.0|-24.5|-16.9|||ANOVA|||Symptom Bother - change from baseline to week 8||-16.9|-24.5|0.007
70870138|NCT03982368|141225754|SUPERIORITY||Least square mean difference|-16.2||||0.305|TWO_SIDED|95.0|-19.9|-12.5|||ANOVA|||Symptom Bother - change from baseline to week 8||-12.5|-19.9|0.305
70870139|NCT03982368|141225754|SUPERIORITY||Least square mean difference|-19.0||||0.015|TWO_SIDED|95.0|-22.7|-15.4|||ANOVA|||Symptom Bother - change from baseline to week 12||-15.4|-22.7|0.015
70870140|NCT03982368|141225754|SUPERIORITY||Least square mean difference|-18.0||||0.039|TWO_SIDED|95.0|-21.5|-14.4|||ANOVA|||Symptom Bother - change from baseline to week 12||-14.4|-21.5|0.039
70870141|NCT03982368|141225754|SUPERIORITY||Least square mean difference|-19.7||||0.001|TWO_SIDED|95.0|-23.3|-16.0|||ANOVA|||||-16.0|-23.3|0.001
70870142|NCT03982368|141225754|SUPERIORITY||Least square mean difference|-18.9||||0.002|TWO_SIDED|95.0|-22.4|-15.3|||ANOVA|||Symptom Bother - change from baseline to week 16||-15.3|-22.4|0.002
70870143|NCT03982368|141225755|SUPERIORITY||Least square mean difference|16.8||||0.241|TWO_SIDED|95.0|12.2|21.4|||ANOVA|||Daily Activity Limitations - change from baseline to week 4||21.4|12.2|0.241
70870144|NCT03982368|141225755|SUPERIORITY||Least square mean difference|19.7||||0.04|TWO_SIDED|95.0|15.1|24.4|||ANOVA|||Daily Activity Limitations - change from baseline to week 4||24.4|15.1|0.040
70870145|NCT03982368|141225755|SUPERIORITY||Least square mean difference|16.8||||0.097|TWO_SIDED|95.0|12.3|21.4|||ANOVA|||Daily Activity Limitations - change from baseline to week 8||21.4|12.3|0.097
70870146|NCT03982368|141225755|SUPERIORITY||Least square mean difference|15.3||||0.238|TWO_SIDED|95.0|10.7|19.9|||ANOVA|||Daily Activity Limitations - change from baseline to week 8||19.9|10.7|0.238
70870147|NCT03982368|141225755|SUPERIORITY||Least square mean difference|16.5||||0.07|TWO_SIDED|95.0|12.0|20.9|||ANOVA|||Daily Activity Limitations - change from baseline to week 12||20.9|12.0|0.070
70870148|NCT03982368|141225755|SUPERIORITY||Least square mean difference|16.7||||0.058|TWO_SIDED|95.0|12.3|21.1|||ANOVA|||Daily Activity Limitations - change from baseline to week 12||21.1|12.3|0.058
70870149|NCT03982368|141225755|SUPERIORITY||Least square mean difference|13.7||||0.128|TWO_SIDED|95.0|9.3|18.1|||ANOVA|||Daily Activity Limitations - change from baseline to week 16||18.1|9.3|0.128
70870150|NCT03982368|141225755|SUPERIORITY||Least square mean difference|16.0||||0.024|TWO_SIDED|95.0|11.6|20.3|||ANOVA|||Daily Activity Limitations - change from baseline to week 16||20.3|11.6|0.024
70870151|NCT03982368|141225755|SUPERIORITY||Least square mean difference|15.2||||0.865|TWO_SIDED|95.0|10.4|20.1|||ANOVA|||Emotional Well-Being - change from baseline to week 4||20.1|10.4|0.865
70870152|NCT03982368|141225755|SUPERIORITY||Least square mean difference|17.3||||0.662|TWO_SIDED|95.0|12.4|22.2|||ANOVA|||Emotional Well-Being - change from baseline to week 4||22.2|12.4|0.662
70870153|NCT03982368|141225755|SUPERIORITY||Least square mean difference|16.7||||0.266|TWO_SIDED|95.0|12.2|21.1|||ANOVA|||Emotional Well-Being - change from baseline to week 8||21.1|12.2|0.266
70870154|NCT03982368|141225755|SUPERIORITY||Least square mean difference|13.9||||0.824|TWO_SIDED|95.0|9.4|18.3|||ANOVA|||Emotional Well-Being - change from baseline to week 8||18.3|9.4|0.824
70870155|NCT03982368|141225755|SUPERIORITY||Least square mean difference|14.8||||0.883|TWO_SIDED|95.0|10.6|19.0|||ANOVA|||Emotional Well-Being - change from baseline to week 12||19.0|10.6|0.883
70870156|NCT03982368|141225755|SUPERIORITY||Least square mean difference|16.3||||0.516|TWO_SIDED|95.0|12.1|20.4|||ANOVA|||Emotional Well-Being - change from baseline to week 12||20.4|12.1|0.516
70870157|NCT03982368|141225755|SUPERIORITY|Emotional Well-Being - change from baseline to week 16|Least square mean difference|16.5||||0.407|TWO_SIDED|95.0|12.1|21.0|||ANOVA|||Emotional Well-Being - change from baseline to week 16||21.0|12.1|0.407
70870158|NCT03982368|141225755|SUPERIORITY||Least square mean difference|16.4||||0.422|TWO_SIDED|95.0|12.0|20.9|||ANOVA|||Emotional Well-Being - change from baseline to week 16||20.9|12.0|0.422
70870159|NCT03982368|141225755|SUPERIORITY||Least square mean difference|15.9||||0.615|TWO_SIDED|95.0|8.1|23.8|||ANOVA|||Work Limitations - change from baseline to week 4||23.8|8.1|0.615
70952758|NCT02683785|141407178|OTHER||Mean Difference (Net)|-0.6||||0.331|TWO_SIDED|95.0|-1.9|0.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 10|||0.7|-1.9|0.331
70952759|NCT02683785|141407178|OTHER||Mean Difference (Net)|-0.8||||0.248|TWO_SIDED|95.0|-2.1|0.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 12|||0.6|-2.1|0.248
70870160|NCT03982368|141225755|SUPERIORITY||Least square mean difference|21.3||||0.626|TWO_SIDED|95.0|13.3|29.2|||ANOVA|||Work Limitations - change from baseline to week 4||29.2|13.3|0.626
70870161|NCT03982368|141225755|SUPERIORITY||Least square mean difference|18.3||||0.968|TWO_SIDED|95.0|11.1|25.6|||ANOVA|||Work Limitations - change from baseline to week 8||25.6|11.1|0.968
70870162|NCT03982368|141225755|SUPERIORITY||Least square mean difference|20.1||||0.689|TWO_SIDED|95.0|12.8|27.4|||ANOVA|||||27.4|12.8|0.689
70870163|NCT03982368|141225755|SUPERIORITY||Least square mean difference|15.6||||0.528|TWO_SIDED|95.0|8.5|22.7|||ANOVA|||Work Limitations - change from baseline to week 12||22.7|8.5|0.528
70870164|NCT03982368|141225755|SUPERIORITY||Least square mean difference|23.0||||0.368|TWO_SIDED|95.0|15.8|30.1|||ANOVA|||Work Limitations - change from baseline to week 12||30.1|15.8|0.368
70870165|NCT03982368|141225755|SUPERIORITY||Least square mean difference|17.7||||0.764|TWO_SIDED|95.0|10.7|24.7|||ANOVA|||Work Limitations - change from baseline to week 16||24.7|10.7|0.764
70870166|NCT03982368|141225755|SUPERIORITY||Least square mean difference|22.6||||0.184|TWO_SIDED|95.0|15.5|29.6|||ANOVA|||Work Limitations - change from baseline to week 16||29.6|15.5|0.184
70870167|NCT03982368|141225755|SUPERIORITY||Least square mean difference|25.4||||0.909|TWO_SIDED|95.0|16.5|34.2|||ANOVA|||Treatment Satisfaction - change from baseline to week 4||34.2|16.5|0.909
70870168|NCT03982368|141225755|SUPERIORITY||Least square mean difference|21.1||||0.428|TWO_SIDED|95.0|12.2|30.0|||ANOVA|||Treatment Satisfaction - change from baseline to week 4||30.0|12.2|0.428
70870169|NCT03982368|141225755|SUPERIORITY||Least square mean difference|29.8||||0.008|TWO_SIDED|95.0|21.6|37.9|||ANOVA|||Treatment Satisfaction - change from baseline to week 8||37.9|21.6|0.008
70870170|NCT03982368|141225755|SUPERIORITY||Least square mean difference|21.3||||0.222|TWO_SIDED|95.0|13.5|29.2|||ANOVA|||Treatment Satisfaction - change from baseline to week 8||29.2|13.5|0.222
70870171|NCT03982368|141225755|SUPERIORITY||Least square mean difference|25.3||||0.082|TWO_SIDED|95.0|17.2|33.4|||ANOVA|||Treatment Satisfaction - change from baseline to week 12||33.4|17.2|0.082
70870172|NCT03982368|141225755|SUPERIORITY||Least square mean difference|23.3||||0.154|TWO_SIDED|95.0|15.6|31.1|||ANOVA|||Treatment Satisfaction - change from baseline to week 12||31.1|15.6|0.154
70870173|NCT03982368|141225755|SUPERIORITY||Least square mean difference|25.8||||0.03|TWO_SIDED|95.0|18.0|33.6|||ANOVA|||Treatment Satisfaction - change from baseline to week 16||33.6|18.0|0.030
70870174|NCT03982368|141225755|SUPERIORITY||Least square mean difference|24.6||||0.046|TWO_SIDED|95.0|17.1|32.1|||ANOVA|||Treatment Satisfaction - change from baseline to week 16||32.1|17.1|0.046
70870175|NCT03982368|141225755|SUPERIORITY||Least square mean difference|15.4||||0.861|TWO_SIDED|95.0|8.6|22.2|||ANOVA|||Treatment-Related Bother - change from baseline to week 4||22.2|8.6|0.861
70870176|NCT03982368|141225755|SUPERIORITY||Least square mean difference|15.3||||0.865|TWO_SIDED|95.0|9.0|21.7|||ANOVA|||Treatment-Related Bother - change from baseline to week 4||21.7|9.0|0.865
70870177|NCT03982368|141225755|SUPERIORITY||Least square mean difference|10.5||||0.278|TWO_SIDED|95.0|3.6|17.3|||ANOVA|||Treatment-Related Bother - change from baseline to week 8||17.3|3.6|0.278
70870178|NCT03982368|141225755|SUPERIORITY||Least square mean difference|7.2||||0.689|TWO_SIDED|95.0|0.9|13.5|||ANOVA|||Treatment-Related Bother - change from baseline to week 8||13.5|0.9|0.689
70870179|NCT03982368|141225755|SUPERIORITY||Least square mean difference|9.1||||0.993|TWO_SIDED|95.0|2.1|16.2|||ANOVA|||Treatment-Related Bother - change from baseline to week 12||16.2|2.1|0.993
70870180|NCT03982368|141225755|SUPERIORITY||Least square mean difference|9.2||||0.989|TWO_SIDED|95.0|2.8|15.7|||ANOVA|||Treatment-Related Bother - change from baseline to week 12||15.7|2.8|0.989
70870181|NCT03982368|141225755|SUPERIORITY||Least square mean difference|10.4||||0.976|TWO_SIDED|95.0|3.7|17.0|||ANOVA|||Treatment-Related Bother - change from baseline to week 16||17.0|3.7|0.976
70870182|NCT03982368|141225755|SUPERIORITY||Least square mean difference|9.0||||0.778|TWO_SIDED|95.0|2.9|15.1|||ANOVA|||Treatment-Related Bother - change from baseline to week 16||15.1|2.9|0.778
70870183|NCT03982368|141225755|SUPERIORITY||Least square mean difference|-17.3||||0.964|TWO_SIDED|95.0|-21.2|-13.3|||ANOVA|||Symptom Bother - change from baseline to week 4||-13.3|-21.2|0.964
70870184|NCT03982368|141225755|SUPERIORITY||Least square mean difference|-18.7||||0.581|TWO_SIDED|95.0|-22.7|-14.7|||ANOVA|||Symptom Bother - change from baseline to week 4||-14.7|-22.7|0.581
70870185|NCT03982368|141225755|SUPERIORITY||Least square mean difference|-21.4||||0.006|TWO_SIDED|95.0|-25.2|-17.5|||ANOVA|||Symptom Bother - change from baseline to week 8||-17.5|-25.2|0.006
70870186|NCT03982368|141225755|SUPERIORITY||Least square mean difference|-17.6||||0.175|TWO_SIDED|95.0|-21.4|-13.7|||ANOVA|||Symptom Bother - change from baseline to week 8||-13.7|-21.4|0.175
70870187|NCT03982368|141225755|SUPERIORITY||Least square mean difference|-19.4||||0.016|TWO_SIDED|95.0|-23.1|-15.6|||ANOVA|||Symptom Bother - change from baseline to week 12||-15.6|-23.1|0.016
70870188|NCT03982368|141225755|SUPERIORITY||Least square mean difference|-19.8||||0.01|TWO_SIDED|95.0|-23.5|-16.1|||ANOVA|||Symptom Bother - change from baseline to week 12||-16.1|-23.5|0.010
70870189|NCT03982368|141225755|SUPERIORITY||Least square mean difference|-20.5||||0|TWO_SIDED|95.0|-24.3|-16.8|||ANOVA|||Symptom Bother - change from baseline to week 16||-16.8|-24.3|0.000
70870190|NCT03982368|141225755|SUPERIORITY||Least square mean difference|-20.8||||0|TWO_SIDED|95.0|-24.6|-17.1|||ANOVA|||Symptom Bother - change from baseline to week 16||-17.1|-24.6|0.000
70870191|NCT03982368|141225756|SUPERIORITY|||||||0.302|||||||Wilcoxon (Mann-Whitney)|||at week 4||||0.302
70870192|NCT03982368|141225756|SUPERIORITY|||||||0.224|||||||Wilcoxon (Mann-Whitney)|||at week 4||||0.224
70870193|NCT03982368|141225756|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||at week 8 (FUP)||||0.000
70870194|NCT03982368|141225756|SUPERIORITY|||||||0.885|||||||Wilcoxon (Mann-Whitney)|||at week 8 (FUP)||||0.885
70870195|NCT03982368|141225756|SUPERIORITY|||||||0.035|||||||Wilcoxon (Mann-Whitney)|||At week 12 (FUP)||||0.035
70870196|NCT03982368|141225756|SUPERIORITY|||||||0.698|||||||Wilcoxon (Mann-Whitney)|||At week 12 (FUP)||||0.698
70870197|NCT03982368|141225756|SUPERIORITY|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||At week 16 (FUP)||||0.016
70870198|NCT03982368|141225756|SUPERIORITY|||||||0.706|||||||Wilcoxon (Mann-Whitney)|||At week 16 (FUP)||||0.706
70870199|NCT03982368|141225757|SUPERIORITY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||at week 4||||0.210
70870200|NCT03982368|141225757|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||at weeek 4||||0.260
70870201|NCT03982368|141225757|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||At week 8 (FUP)||||0.000
70870202|NCT03982368|141225757|SUPERIORITY|||||||0.734|||||||Wilcoxon (Mann-Whitney)|||at week 8 (FUP)||||0.734
70870203|NCT03982368|141225757|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||at week 12 (FUP)||||0.050
70870204|NCT03982368|141225757|SUPERIORITY|||||||0.985|||||||Wilcoxon (Mann-Whitney)|||at week 12 (FUP)||||0.985
70870205|NCT03982368|141225757|SUPERIORITY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||at week 16 (FUP)||||0.018
70870206|NCT03982368|141225757|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||at week 16 (FUP)||||0.580
70870207|NCT03982368|141225758|SUPERIORITY||Least square mean difference|1.2||||0.282|TWO_SIDED|95.0|-1.0|3.3|||ANOVA|||statistical analysis at week 4||3.3|-1.0|0.282
71144923|NCT03270436|141783220|SUPERIORITY|||||||0.6928||||||The p-value above reflects results of between-arms analysis of mean change in eating self-efficacy scores from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.6928
71144924|NCT03270436|141783220|SUPERIORITY|||||||0.4947||||||The p-value above reflects results of between-arms analysis of mean change in eating self-efficacy scores from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.4947
71144925|NCT03270436|141783221|SUPERIORITY|||||||0.1539||||||The p-value above reflects results of between-arms analysis of mean change in physical activity self-efficacy scores from baseline to immediate post-intervention. Analyses do not include imputed values|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.1539
71144926|NCT03270436|141783221|SUPERIORITY|||||||0.1878||||||The p-value above reflects results of between-arms analysis of mean change in physical activity self-efficacy scores from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.1878
71144927|NCT03270436|141783222|SUPERIORITY|||||||0.4322||||||The p-value above reflects results of between-arms analysis of mean change in family support scale scores from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.4322
71144928|NCT03270436|141783222|SUPERIORITY|||||||0.9529||||||The p-value above reflects results of between-arms analysis of mean change in family support scale scores from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.9529
71144929|NCT02535481|141783297|SUPERIORITY|||||||0.366||||||At 6 weeks|Fisher Exact|||||||0.366
71144930|NCT02535481|141783297|SUPERIORITY|||||||0.24||||||At 3 months|Fisher Exact|||||||0.24
71144931|NCT02535481|141783298|SUPERIORITY||||||<|0.0001|||||||Log Rank|Kaplan-Meier analysis of cumulative wound healing followed by a log rank test||||||<0.0001
70870208|NCT03982368|141225758|SUPERIORITY||Least square mean difference|3.9||||0.497|TWO_SIDED|95.0|1.7|6.0|||ANOVA|||statistical analysis at week 4||6.0|1.7|0.497
71144932|NCT02535481|141783299|SUPERIORITY|||||||0.12|||||||Log Rank|||||||0.12
71144933|NCT02535481|141783300|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
71144934|NCT02535481|141783301|SUPERIORITY|||||||0.001||||||At 6 weeks|Wilcoxon (Mann-Whitney)|||||||0.001
71144935|NCT02535481|141783301|SUPERIORITY|||||||0.001||||||At 3 months|Wilcoxon (Mann-Whitney)|||||||0.001
71144936|NCT00904943|141783336|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (test/ref x 100)|104.27|||||TWO_SIDED||||||||Bioequivalence is established when Ratio of the Mean falls within 80-125.|||||
71144937|NCT00904943|141783337|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (test/ref x 100)|102.35|||||TWO_SIDED||||||||Bioequivalence is established when Ratio of the Least Squares Mean falls within 80-125.|||||
71144938|NCT00904943|141783338|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (test/ref x 100)|103.66|||||TWO_SIDED||||||||Bioequivalence is established when Ratio of the Least Squares Mean falls within 80-125.|||||
71144939|NCT05546476|141783339|SUPERIORITY||Difference in Posterior Median|1.33|||||TWO_SIDED|90.0|0.49|2.34||||||Bayesian Emax model was used for statistical calculation. The posterior medians and 90% credible intervals (5th and 95th percentiles of the relevant posterior distribution) were reported for differences relative to placebo). No adjustments were made for multiplicity.||2.34|0.49|
71144940|NCT05546476|141783339|SUPERIORITY||Difference in Posterior Median|2.08|||||TWO_SIDED|90.0|1.08|3.15||||||Bayesian Emax model was used for statistical calculation. The posterior medians and 90% credible intervals (5th and 95th percentiles of the relevant posterior distribution) were reported for differences relative to placebo). No adjustments were made for multiplicity.||3.15|1.08|
71144941|NCT05546476|141783339|SUPERIORITY||Difference in Posterior Median|3.0|||||TWO_SIDED|90.0|1.68|4.34||||||Bayesian Emax model was used for statistical calculation. The posterior medians and 90% credible intervals (5th and 95th percentiles of the relevant posterior distribution) were reported for differences relative to placebo). No adjustments were made for multiplicity.||4.34|1.68|
71144942|NCT05546476|141783340|SUPERIORITY||Difference in LS Mean|53.36|||=|0.826|TWO_SIDED|90.0|-40.89|147.6|||MMRM analysis; 1-sided|||Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||147.60|-40.89|=0.8260
70870209|NCT03982368|141225758|SUPERIORITY||Least square mean difference|2.6||||0.734|TWO_SIDED|95.0|0.5|4.8|||ANOVA|||statistical analysis at week 8||4.8|0.5|0.734
70870210|NCT03982368|141225758|SUPERIORITY||Least square mean difference|2.2||||0.963|TWO_SIDED|95.0|0.1|4.3|||ANOVA|||statistical analysis at week 8||4.3|0.1|0.963
70870211|NCT03982368|141225758|SUPERIORITY||Least square mean difference|2.7||||0.854|TWO_SIDED|95.0|0.7|4.8|||ANOVA|||statistical analysis at week 12||4.8|0.7|0.854
70870212|NCT03982368|141225758|SUPERIORITY||Least square mean difference|2.8||||0.881|TWO_SIDED|95.0|0.8|4.8|||ANOVA|||statistical analysis at week 12||4.8|0.8|0.881
70870213|NCT03982368|141225758|SUPERIORITY||Least square mean difference|3.0||||0.632|TWO_SIDED|95.0|0.3|5.7|||ANOVA|||statistical analysis at week 16||5.7|0.3|0.632
70870214|NCT03982368|141225758|SUPERIORITY||Least square mean difference|4.4||||0.22|TWO_SIDED|95.0|1.7|7.0|||ANOVA|||statistical analysis at week 16||7.0|1.7|0.220
70870215|NCT03982368|141225759|SUPERIORITY||Least square mean difference|1.2||||0.296|TWO_SIDED|95.0|-0.9|3.3|||ANOVA|||statistical analysis at week 4||3.3|-0.9|0.296
70870216|NCT03982368|141225759|SUPERIORITY||Least square mean difference|3.6||||0.57|TWO_SIDED|95.0|1.5|5.7|||ANOVA|||statistical analysis at week 4||5.7|1.5|0.570
70870217|NCT03982368|141225759|SUPERIORITY||Least square mean difference|2.7||||0.754|TWO_SIDED|95.0|0.5|4.9|||ANOVA|||statistical analysis at week 8||4.9|0.5|0.754
70870218|NCT03982368|141225759|SUPERIORITY||Least square mean difference|2.3||||0.972|TWO_SIDED|95.0|0.0|4.5|||ANOVA|||statistical analysis at week 8||4.5|0.0|0.972
70870219|NCT03982368|141225759|SUPERIORITY||Least square mean difference|3.4||||0.793|TWO_SIDED|95.0|1.4|5.3|||ANOVA|||statistical analysis at week 12||5.3|1.4|0.793
70870220|NCT03982368|141225759|SUPERIORITY||Least square mean difference|3.4||||0.766|TWO_SIDED|95.0|1.5|5.3|||ANOVA|||statistical analysis at week 12||5.3|1.5|0.766
70870221|NCT03982368|141225759|SUPERIORITY||Least square mean difference|3.3||||0.458|TWO_SIDED|95.0|0.6|6.0|||ANOVA|||statistical analysis at week 16||6.0|0.6|0.458
70952760|NCT02683785|141407178|OTHER||Mean Difference (Net)|-2.9||||0.35|TWO_SIDED|95.0|-9.0|3.3||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 1|||3.3|-9.0|0.350
70870222|NCT03982368|141225759|SUPERIORITY||Least square mean difference|4.6||||0.147|TWO_SIDED|95.0|2.0|7.3|||ANOVA|||statistical analysis at week 16||7.3|2.0|0.147
70870223|NCT03706079|141225760|SUPERIORITY||Rate Ratio|0.42|||||TWO_SIDED|95.0|0.35|0.51||||||||0.51|0.35|
70870224|NCT03706079|141225760|SUPERIORITY||Rate Ratio|0.61|||||TWO_SIDED|95.0|0.38|0.96||||||||0.96|0.38|
70870225|NCT00329238|141225763|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons between treatment groups were performed using a Cox regression analysis with treatment and baseline stratification factor in the model.|Hazard Ratio (HR)|1.44||||0.0137||95.0|0.78|2.64||p-value for non-inferiority. The non-inferiority margin for the hazard ratio was chosen to be 2.85.|Regression, Cox|HR within cohort estimated by Cox regr. with treatment and baseline stratific. factor. Overall HR calc. by pooling with inverse variance weighting.|HR for time to first recurrent VTE or VTE death.|||2.64|0.78|0.0137
70870226|NCT00329238|141225763|SUPERIORITY_OR_OTHER|||||||0.2424||||||p-value for superiority. If non-inferiority could be established for HR and for the risk difference, the upper bound of the 95% CI for the hazard ratio was then compared with 1 to evaluate the superiority claim of dabigatran over warfarin.|Regression, Cox|||||||0.2424
70870227|NCT00329238|141225764|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons between treatment groups were performed using a Cox regression analysis with treatment and baseline stratification factor in the model.|Risk Difference (RD)|0.38|||<|0.0001||95.0|-0.5|1.25||p-value for non-inferiority. The non-inferiority margin for the risk difference was chosen to be 2.80.|Regression, Cox|Risk difference for time to first recurrent VTE/VTE death is calculated based on weighted KM estimates across the cohorts via meta-analysis approach.||||1.25|-0.50|<0.0001
70870228|NCT00329238|141225764|SUPERIORITY_OR_OTHER|||||||0.4013||||||p-value for superiority. If non-inferiority could be established for HR and for the risk difference, the upper bound of the 95% CI for the risk difference was then compared with 0 to evaluate the superiority claim of dabigatran over warfarin.|Kaplan-Meier|||||||0.4013
70870229|NCT00329238|141225765|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.4732||95.0|0.75|1.84|||Regression, Cox|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.|HR for time to first centrally adjudicated recurrent VTE or all cause death.|||1.84|0.75|0.4732
70870230|NCT00329238|141225766|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.09||||0.8876||95.0|-1.11|1.28|||Kaplan-Meier|Risk difference for the time to first centrally adjudicated recurrent VTE or all cause death at month 18.||Dabigatran versus Warfarin||1.28|-1.11|0.8876
70870231|NCT00329238|141225767|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.4548||95.0|0.64|2.71|||Regression, Cox|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.|HR for time to first centrally adjudicated recurrent symptomatic DVT|Dabigatran versus Warfarin||2.71|0.64|0.4548
70870232|NCT00329238|141225768|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.19||||0.6563||95.0|-0.63|1.0|||Kaplan-Meier|Risk difference for the time to first centrally adjudicated recurrent symptomatic DVT at Month 18.||Dabigatran versus Warfarin||1.00|-0.63|0.6563
70870233|NCT00329238|141225769|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.04||||0.1925||95.0|0.7|5.98|||Regression, Cox|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.|Hazard ratio for time to first centrally adjudicated recurrent symptomatic PE.|Dabigatran versus Warfarin||5.98|0.70|0.1925
70870234|NCT00329238|141225770|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.26||||0.3723||95.0|-0.32|0.84|||Kaplan-Meier||Risk difference for the time to first centrally adjudicated recurrent symptomatic PE at Month 18|Dabigatran versus Warfarin||0.84|-0.32|0.3723
70870235|NCT00329238|141225771|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9921||95.0|0.06|16.22|||Regression, Cox|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.|Hazard ratio for time to deaths related to VTE.|Dabigatran versus Warfarin||16.22|0.06|0.9921
70952761|NCT02683785|141407178|OTHER||Mean Difference (Net)|-3.0||||0.383|TWO_SIDED|95.0|-9.8|3.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 2|||3.8|-9.8|0.383
70870236|NCT00329238|141225772|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.01||||0.9204||95.0|-0.2|0.23|||Kaplan-Meier|Risk difference for the time to deaths related to VTE at Month 18.||Dabigatran versus Warfarin||0.23|-0.20|0.9204
70870237|NCT00329238|141225773|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.7405||95.0|0.47|1.72|||Regression, Cox|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.|Hazard ratio for time to all deaths|Dabigatran versus Warfarin||1.72|0.47|0.7405
70870238|NCT00329238|141225774|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.02||||0.9622||95.0|-0.89|0.84|||Kaplan-Meier|Risk difference for the time to all deaths at Month 18.||Dabigatran versus Warfarin||0.84|-0.89|0.9622
70870239|NCT00329238|141225775|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.52||||0.0577||95.0|0.27|1.02|||Regression, Cox||This is the analysis of the time to the first MBE.|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors (including active cancer at baseline and symptomatic PE as qualifying event) and their interaction.||1.02|0.27|0.0577
70870240|NCT00329238|141225775|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.61|0.83|||Regression, Cox||This is the analysis of the time to the first occurrence of any bleeding event.|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors (including active cancer at baseline and symptomatic PE as qualifying event) and their interaction.||0.83|0.61|<0.0001
70870241|NCT03652012|141225779|SUPERIORITY||Mean Difference (Final Values)|54.2||||0.044|TWO_SIDED|95.0|1.54|106.85||As multiple parameters were assessed from the stimulus-response curve, a Bonferroni-adjusted alpha threshold of α = 0.0125 was applied to account for multiple comparisons when assessing this outcome measure.|ANOVA||Mean difference (Healthy Controls - MCI).|"We conducted a two-way factorial ANOVA (Group x Condition). Group has two levels: MCI and Healthy controls. Condition has two levels: active muscle contraction and rest.~As multiple parameters were assessed from the stimulus-response curve, a Bonferroni-adjusted alpha threshold of α = 0.0125 was applied to account for multiple comparisons when assessing this outcome measure."||106.85|1.54|0.044
70870242|NCT03652012|141225779|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.912|TWO_SIDED|95.0|-51.87|57.47||As multiple parameters were assessed from the stimulus-response curve, a Bonferroni-adjusted alpha threshold of α = 0.0125 was applied to account for multiple comparisons when assessing this outcome measure.|ANOVA||Mean difference in slope of the stimulus-response curve by muscle contraction condition (Active - Rest).|"We conducted a two-way factorial ANOVA (Group x Condition). Group has two levels: MCI and Healthy controls. Condition has two levels: active muscle contraction and rest.~As multiple parameters were assessed from the stimulus-response curve, a Bonferroni-adjusted alpha threshold of α = 0.0125 was applied to account for multiple comparisons when assessing this outcome measure.~The results presented here reflect the main effect of Condition on the slope of the stimulus-response curve."||57.47|-51.87|0.912
70870243|NCT03652012|141225780|SUPERIORITY||Mean Difference (Final Values)|20.6||||0.1021|TWO_SIDED|95.0|-4.33|45.54|||t-test, 2 sided|No adjustment for multiple comparisons.|Mean cortical silent period (CSP; units = milliseconds) in the CN group minus mean CSP in the MCI group. Positive values indicate a longer cortical silent period in the control group.|||45.54|-4.33|0.1021
70870244|NCT03652012|141225781|SUPERIORITY||Mean Difference (Final Values)|0.208||||0.19|TWO_SIDED|95.0|-0.113|0.529|||t-test, 2 sided|||||0.529|-0.113|0.19
70870245|NCT03652012|141225782|SUPERIORITY||Mean Difference (Net)|0.0078||||0.97|TWO_SIDED|95.0|-0.51|0.5|||t-test, 2 sided|||||0.50|-0.51|0.97
70870246|NCT01302834|141225799|NON_INFERIORITY|The non-inferiority margin was set at 1.45 (hazard ratio scale; IMRT + Cetuximab / IMRT + Cisplatin). If the upper limit of the 95% confidence interval was \<1.45, non-inferiority would be concluded. Design was based on a group sequential design with 3 interim analyses, one-sided 0.05, and 80% power.|Hazard Ratio (HR)|1.45|||||ONE_SIDED|95.0||1.94|||||Reference level = IMRT + Cisplatin|||1.94||
70870247|NCT01302834|141225800|SUPERIORITY||Hazard Ratio (HR)|1.72||||0.0002|TWO_SIDED|95.0|1.29|2.29|||Log Rank|Two-sided significance level = 0.05|Reference level = IMRT + Cisplatin|||2.29|1.29|0.0002
70952762|NCT02683785|141407178|OTHER||Mean Difference (Net)|-4.8||||0.271|TWO_SIDED|95.0|-13.5|3.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 4|||3.9|-13.5|0.271
70870248|NCT01302834|141225801|SUPERIORITY||Hazard Ratio (HR)|2.05||||0.0005|TWO_SIDED|95.0|1.35|3.1|||Log Rank|Two-sided significance level = 0.05|Reference level = IMRT + Cisplatin|||3.10|1.35|0.0005
71144943|NCT05546476|141783340|SUPERIORITY||Difference in LS Mean|-37.9|||=|0.254|TWO_SIDED|90.0|-132.94|57.14|||MMRM analysis; 1-sided|||Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||57.14|-132.94|=0.2540
70870249|NCT01302834|141225802|SUPERIORITY||Hazard Ratio (HR)|1.49||||0.09|TWO_SIDED|95.0|0.94|2.36||Two-sided significance level = 0.05|Log Rank||Reference level = IMRT + Cisplatin|||2.36|0.94|0.09
70870250|NCT01302834|141225803|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.95|TWO_SIDED|95.0|0.61|1.58||Two-sided significance level = 0.05|Log Rank||Reference level = IMRT + Cisplatin|||1.58|0.61|0.95
70870251|NCT01302834|141225805|SUPERIORITY|||||||1||||||Two-sided significance level = 0.05|Fisher Exact|||||||1.0
70870252|NCT01302834|141225813|SUPERIORITY|||||||0.79||||||Two-sided significance level = 0.05|Fisher Exact|||||||0.79
70870253|NCT01302834|141225816|SUPERIORITY|||||||0.5438||||||One-sided significance level = 0.05|t-test, 1 sided|||||||0.5438
71144944|NCT05546476|141783340|SUPERIORITY||Difference in LS Mean|-1.95|||=|0.487|TWO_SIDED|90.0|-101.63|97.73|||MMRM analysis; 1-sided|||Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||97.73|-101.63|=0.4870
70870254|NCT01302834|141225820|SUPERIORITY|||||||0.7108||||||One-sided significance level = 0.05|t-test, 1 sided|||||||0.7108
70870255|NCT00769392|141225851|OTHER|||||||0.28|||||||single factor analysis of variance|||A comparison of injection discomfort using mean pain scores for all 4 anesthesia intervention agents used in this study.||||0.28
70870256|NCT00769392|141225852|OTHER|||||||0.17|||||||single factor analysis of variance|||A comparison of discomfort of all 4 anesthesia intervention agents used in this study using mean pain scores.||||0.17
70870257|NCT02296320|141225857|SUPERIORITY||Relative risk reduction|31.9||||0.166|TWO_SIDED|90.0|-7.5|56.8|||Poisson regression with robust variance|||The key efficacy analyses were based on 5000 mg MEDI4893 and placebo. Participants who received 2000 mg MEDI4893 were summarized descriptively.||56.8|-7.5|0.166
70870258|NCT01203098|141225880|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|-1.3|||||TWO_SIDED|95.0|-7.2|4.6||||||Primary analyses were performed on proportion of subjects who experienced thromboembolic events defined as primary efficacy endpoint (incidence of thromboembolic events); incidence of thromboembolic events and its 95% confidence interval (CI) were calculated by treatment group, and difference between DU-176b 15 mg and 30 mg groups and its 95% CI were also calculated. For reference, difference between enoxaparin group and each DU-176b group and its 95% CI of each were calculated.||4.6|-7.2|
70870259|NCT01203098|141225880|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.1|||||TWO_SIDED|95.0|-4.6|6.8||||||Primary analyses were performed on proportion of subjects who experienced thromboembolic events defined as primary efficacy endpoint (incidence of thromboembolic events); incidence of thromboembolic events and its 95% confidence interval (CI) were calculated by treatment group, and difference between DU-176b 15 mg and 30 mg groups and its 95% CI were also calculated. For reference, difference between enoxaparin group and each DU-176b group and its 95% CI of each were calculated.||6.8|-4.6|
70870260|NCT00730405|141225882|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70870261|NCT00730405|141225882|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70870262|NCT00730405|141225882|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70870263|NCT00730405|141225882|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70870264|NCT00730405|141225883|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70870265|NCT00730405|141225883|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70870266|NCT00730405|141225883|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70870267|NCT00730405|141225883|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70870268|NCT00730405|141225884|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70870269|NCT00730405|141225884|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70870270|NCT00730405|141225884|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70870271|NCT00730405|141225884|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70870272|NCT00730405|141225885|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70870273|NCT00730405|141225885|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70870274|NCT00730405|141225885|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70870275|NCT00730405|141225885|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70870276|NCT00730405|141225886|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.1|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|||||||ANOVA|||||||<0.001
70870277|NCT00730405|141225886|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.71|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|||||||ANOVA|||||||<0.001
70870278|NCT00730405|141225886|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.44|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|||||||ANOVA|||||||<0.001
70870279|NCT00730405|141225886|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.22|STANDARD_ERROR_OF_MEAN|0.58|<|0.001|||||||ANOVA|||||||<0.001
70870280|NCT00730405|141225887|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70870281|NCT00730405|141225887|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70870282|NCT00730405|141225887|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70870283|NCT00730405|141225887|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70870284|NCT03851705|141225891|SUPERIORITY||Mean Difference (Final Values)|-1.68||||0.9047|TWO_SIDED|95.0|-29.19|25.83||The a priori threshold for statistical significance was \<0.05 (two-sided)|ANCOVA|||||25.83|-29.19|0.9047
70870285|NCT03851705|141225892|SUPERIORITY||Mean Difference (Final Values)|6.47||||0.8685|TWO_SIDED|95.0|-70.11|83.05||The a priori threshold for statistical significance was \<0.05 (two-sided)|ANCOVA|||||83.05|-70.11|0.8685
70870286|NCT03851705|141225893|SUPERIORITY||Mean Difference (Final Values)|-12.1||||0.2347|TWO_SIDED|95.0|-32.2|8.1||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||8.1|-32.2|0.2347
70870287|NCT03851705|141225893|SUPERIORITY||Mean Difference (Final Values)|4.6||||0.7058|TWO_SIDED|95.0|-19.9|29.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||29.2|-19.9|0.7058
70870288|NCT03851705|141225893|SUPERIORITY||Mean Difference (Final Values)|-5.7||||0.5653|TWO_SIDED|95.0|-25.5|14.1||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||14.1|-25.5|0.5653
70870289|NCT03851705|141225895|SUPERIORITY||Mean Difference (Final Values)|-19.9||||0.4589|TWO_SIDED|95.0|-73.3|33.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||33.6|-73.3|0.4589
70870290|NCT03851705|141225895|SUPERIORITY||Mean Difference (Final Values)|17.7||||0.5956|TWO_SIDED|95.0|-48.8|84.3||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||84.3|-48.8|0.5956
70870291|NCT03851705|141225895|SUPERIORITY||Mean Difference (Final Values)|-7.5||||0.7861|TWO_SIDED|95.0|-62.7|47.7||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||47.7|-62.7|0.7861
70870292|NCT03851705|141225897|SUPERIORITY||Mean Difference (Final Values)|-62.6|||<|0.0001|TWO_SIDED|95.0|-80.1|-45.1||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||-45.1|-80.1|<.0001
70870293|NCT03851705|141225897|SUPERIORITY||Mean Difference (Final Values)|-60.6|||<|0.0001|TWO_SIDED|95.0|-83.5|-37.8||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||-37.8|-83.5|<.0001
70870294|NCT03851705|141225897|SUPERIORITY||Mean Difference (Final Values)|-92.3|||<|0.0001|TWO_SIDED|95.0|-120.4|-64.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||-64.2|-120.4|<.0001
70870295|NCT03851705|141225899|SUPERIORITY||Mean Difference (Final Values)|-316.6|||<|0.0001|TWO_SIDED|95.0|-420.7|-212.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||-212.6|-420.7|<.0001
70870296|NCT03851705|141225899|SUPERIORITY||Mean Difference (Final Values)|-304.4|||<|0.0001|TWO_SIDED|95.0|-408.0|-200.8||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||-200.8|-408.0|<.0001
71144945|NCT05546476|141783340|SUPERIORITY||Difference in LS Mean|37.76|||=|0.0497|TWO_SIDED|90.0|0.07|75.46|||MMRM analysis; 1-sided|||Non-Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||75.46|0.07|=0.0497
71144946|NCT05546476|141783340|SUPERIORITY||Difference in LS Mean|-4.36|||=|0.5745|TWO_SIDED|90.0|-42.94|34.22|||MMRM analysis; 1-sided|||Non-Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||34.22|-42.94|=0.5745
70952763|NCT02683785|141407178|OTHER||Mean Difference (Net)|-2.7||||0.565|TWO_SIDED|95.0|-12.1|6.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 6|||6.7|-12.1|0.565
70952764|NCT02683785|141407178|OTHER||Mean Difference (Net)|-4.9||||0.343|TWO_SIDED|95.0|-15.2|5.4||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 8|||5.4|-15.2|0.343
70952765|NCT02683785|141407178|OTHER||Mean Difference (Net)|-6.2||||0.266|TWO_SIDED|95.0|-17.3|4.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 10|||4.9|-17.3|0.266
70952766|NCT02683785|141407178|OTHER||Mean Difference (Net)|-8.2||||0.136|TWO_SIDED|95.0|-19.1|2.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 12|||2.7|-19.1|0.136
70952767|NCT02683785|141407178|OTHER||Mean Difference (Net)|-5.5||||0.23|TWO_SIDED|95.0|-14.5|3.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 1|||3.6|-14.5|0.230
70952768|NCT02683785|141407178|OTHER||Mean Difference (Net)|-4.6||||0.381|TWO_SIDED|95.0|-15.2|5.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 2|||5.9|-15.2|0.381
70952769|NCT02683785|141407178|OTHER||Mean Difference (Net)|-8.7||||0.207|TWO_SIDED|95.0|-22.4|5.0||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 4|||5.0|-22.4|0.207
70952770|NCT02683785|141407178|OTHER||Mean Difference (Net)|-3.4||||0.648|TWO_SIDED|95.0|-18.4|11.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 6|||11.6|-18.4|0.648
70952771|NCT02683785|141407178|OTHER||Mean Difference (Net)|-9.0||||0.278|TWO_SIDED|95.0|-25.4|7.5||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 8|||7.5|-25.4|0.278
70952772|NCT02683785|141407178|OTHER||Mean Difference (Net)|-12.1||||0.16|TWO_SIDED|95.0|-29.1|5.0||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 10|||5.0|-29.1|0.160
70952773|NCT02683785|141407178|OTHER||Mean Difference (Net)|-13.3||||0.127|TWO_SIDED|95.0|-30.5|3.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 12|||3.9|-30.5|0.127
70952774|NCT02683785|141407179|OTHER||Mean Difference (Net)|0.0||||0.957|TWO_SIDED|95.0|-1.9|1.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 1 is presented|||1.8|-1.9|0.957
70952775|NCT02683785|141407179|OTHER||Mean Difference (Net)|0.3||||0.775|TWO_SIDED|95.0|-2.1|2.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented|||2.8|-2.1|0.775
70952776|NCT02683785|141407179|OTHER||Mean Difference (Net)|-0.5||||0.624|TWO_SIDED|95.0|-2.7|1.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented|||1.7|-2.7|0.624
70870297|NCT03851705|141225899|SUPERIORITY||Mean Difference (Final Values)|-390.4|||<|0.0001|TWO_SIDED|95.0|-504.5|-276.3||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||-276.3|-504.5|<.0001
70870298|NCT03851705|141225901|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.3299|TWO_SIDED|95.0|-23.9|8.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||8.2|-23.9|0.3299
70870299|NCT03851705|141225901|SUPERIORITY||Mean Difference (Final Values)|2.7||||0.7778|TWO_SIDED|95.0|-16.7|22.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||22.2|-16.7|0.7778
70870300|NCT03851705|141225901|SUPERIORITY||Mean Difference (Final Values)|-3.5||||0.6613|TWO_SIDED|95.0|-19.2|12.3||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||12.3|-19.2|0.6613
70870301|NCT03851705|141225902|SUPERIORITY||Mean Difference (Final Values)|-19.0||||0.4911|TWO_SIDED|95.0|-74.0|36.0||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||36.0|-74.0|0.4911
70870302|NCT03851705|141225902|SUPERIORITY||Mean Difference (Final Values)|11.1||||0.7461|TWO_SIDED|95.0|-57.2|79.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||79.4|-57.2|0.7461
70870303|NCT03851705|141225902|SUPERIORITY||Mean Difference (Final Values)|-5.9||||0.837|TWO_SIDED|95.0|-62.8|51.1||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||51.1|-62.8|0.8370
70870304|NCT03851705|141225905|SUPERIORITY||Mean Difference (Final Values)|-12.7||||0.1371|TWO_SIDED|95.0|-29.5|4.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||4.2|-29.5|0.1371
70870305|NCT03851705|141225905|SUPERIORITY||Mean Difference (Final Values)|-3.5||||0.71|TWO_SIDED|95.0|-22.6|15.5||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||15.5|-22.6|0.7100
70952777|NCT02683785|141407179|OTHER||Mean Difference (Net)|1.4||||0.243|TWO_SIDED|95.0|-1.0|3.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 6 is presented|||3.8|-1.0|0.243
70952778|NCT02683785|141407179|OTHER||Mean Difference (Net)|0.2||||0.875|TWO_SIDED|95.0|-2.5|2.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented|||2.9|-2.5|0.875
70952779|NCT02683785|141407179|OTHER||Mean Difference (Net)|-0.3||||0.848|TWO_SIDED|95.0|-3.4|2.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 10 is presented|||2.8|-3.4|0.848
70870306|NCT03851705|141225905|SUPERIORITY||Mean Difference (Final Values)|-10.3||||0.2278|TWO_SIDED|95.0|-27.2|6.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||6.6|-27.2|0.2278
70870307|NCT03851705|141225907|SUPERIORITY||Mean Difference (Final Values)|-19.4||||0.2044|TWO_SIDED|95.0|-49.7|10.9||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||10.9|-49.7|0.2044
70870308|NCT03851705|141225907|SUPERIORITY||Mean Difference (Final Values)|-4.8||||0.7875|TWO_SIDED|95.0|-39.9|30.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||30.4|-39.9|0.7875
70952780|NCT02683785|141407179|OTHER||Mean Difference (Net)|-0.2||||0.883|TWO_SIDED|95.0|-2.8|2.4||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented|||2.4|-2.8|0.883
70952781|NCT02683785|141407180|OTHER||Mean Difference (Net)|-1.2||||0.463|TWO_SIDED|95.0|-4.4|2.0||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 1 is presented|||2.0|-4.4|0.463
70952782|NCT02683785|141407180|OTHER||Mean Difference (Net)|-0.4||||0.809|TWO_SIDED|95.0|-3.7|2.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented|||2.9|-3.7|0.809
70952783|NCT02683785|141407180|OTHER||Mean Difference (Net)|-1.9||||0.324|TWO_SIDED|95.0|-5.8|2.0||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented|||2.0|-5.8|0.324
70870309|NCT03851705|141225907|SUPERIORITY||Mean Difference (Final Values)|-15.8||||0.3193|TWO_SIDED|95.0|-47.3|15.7||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||15.7|-47.3|0.3193
70870310|NCT03851705|141225909|SUPERIORITY||Mean Difference (Final Values)|-10.1||||0.2877|TWO_SIDED|95.0|-29.0|8.8||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||8.8|-29.0|0.2877
70870311|NCT03851705|141225909|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.7944|TWO_SIDED|95.0|-19.7|25.7||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||25.7|-19.7|0.7944
70870312|NCT03851705|141225909|SUPERIORITY||Mean Difference (Final Values)|-5.1||||0.5803|TWO_SIDED|95.0|-23.4|13.3||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||13.3|-23.4|0.5803
70870313|NCT03851705|141225911|SUPERIORITY||Mean Difference (Final Values)|-19.1||||0.4848|TWO_SIDED|95.0|-73.6|35.3||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||35.3|-73.6|0.4848
70870314|NCT03851705|141225911|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.722|TWO_SIDED|95.0|-56.0|80.3||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||80.3|-56.0|0.7220
70870315|NCT03851705|141225911|SUPERIORITY||Mean Difference (Final Values)|-7.0||||0.8036|TWO_SIDED|95.0|-63.6|49.5||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||49.5|-63.6|0.8036
70870316|NCT03851705|141225919|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.6028|TWO_SIDED|95.0|-6.8|11.7||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||11.7|-6.8|0.6028
70870317|NCT03851705|141225919|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.8428|TWO_SIDED|95.0|-11.5|14.0||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||14.0|-11.5|0.8428
70870318|NCT03851705|141225919|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.4946|TWO_SIDED|95.0|-6.6|13.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||13.4|-6.6|0.4946
70870319|NCT03851705|141225921|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.9237|TWO_SIDED|95.0|-4.0|4.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||4.4|-4.0|0.9237
70870320|NCT03851705|141225921|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.7177|TWO_SIDED|95.0|-6.5|4.5||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||4.5|-6.5|0.7177
70870321|NCT03851705|141225921|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.5416|TWO_SIDED|95.0|-2.9|5.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||5.4|-2.9|0.5416
70870322|NCT03851705|141225923|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.6497|TWO_SIDED|95.0|-3.2|5.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||5.2|-3.2|0.6497
70952784|NCT02683785|141407180|OTHER||Mean Difference (Net)|-0.5||||0.783|TWO_SIDED|95.0|-4.2|3.2||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 6 is presented|||3.2|-4.2|0.783
70952785|NCT02683785|141407180|OTHER||Mean Difference (Net)|-1.4||||0.464|TWO_SIDED|95.0|-5.4|2.5||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented|||2.5|-5.4|0.464
70952786|NCT02683785|141407180|OTHER||Mean Difference (Net)|-0.7||||0.736|TWO_SIDED|95.0|-4.9|3.5||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 10 is presented|||3.5|-4.9|0.736
70870323|NCT03851705|141225923|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.3209|TWO_SIDED|95.0|-7.9|2.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||2.6|-7.9|0.3209
70870324|NCT03851705|141225923|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.9294|TWO_SIDED|95.0|-6.3|5.7||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||5.7|-6.3|0.9294
70870325|NCT03851705|141225925|SUPERIORITY||Mean Difference (Final Values)|11.3||||0.3105|TWO_SIDED|95.0|-10.8|33.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||33.4|-10.8|0.3105
70870326|NCT03851705|141225925|SUPERIORITY||Mean Difference (Final Values)|-11.4||||0.3018|TWO_SIDED|95.0|-33.3|10.5||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||10.5|-33.3|0.3018
70870327|NCT03851705|141225925|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.8755|TWO_SIDED|95.0|-27.0|31.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||31.6|-27.0|0.8755
70870328|NCT03851705|141225927|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.6848|TWO_SIDED|95.0|-11.5|7.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||7.6|-11.5|0.6848
70870329|NCT03851705|141225927|SUPERIORITY||Mean Difference (Final Values)|-5.4||||0.4075|TWO_SIDED|95.0|-18.5|7.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||7.6|-18.5|0.4075
70870330|NCT03851705|141225927|SUPERIORITY||Mean Difference (Final Values)|-2.8||||0.5998|TWO_SIDED|95.0|-13.4|7.8||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||7.8|-13.4|0.5998
70870331|NCT03851705|141225929|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.7958|TWO_SIDED|95.0|-8.4|6.5||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||6.5|-8.4|0.7958
70870332|NCT03851705|141225929|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.6003|TWO_SIDED|95.0|-12.7|7.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||7.4|-12.7|0.6003
70870333|NCT03851705|141225929|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.5352|TWO_SIDED|95.0|-11.0|5.8||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||5.8|-11.0|0.5352
70870334|NCT03851705|141225931|SUPERIORITY||Mean Difference (Final Values)|-8.9||||0.1716|TWO_SIDED|95.0|-21.8|4.0||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||4.0|-21.8|0.1716
70952787|NCT02683785|141407180|OTHER||Mean Difference (Net)|-0.5||||0.806|TWO_SIDED|95.0|-4.8|3.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented|||3.7|-4.8|0.806
70952788|NCT02683785|141407181|OTHER||Mean Difference (Net)|0.3||||0.586|TWO_SIDED|95.0|-0.9|1.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented|||1.6|-0.9|0.586
70870335|NCT03851705|141225931|SUPERIORITY||Mean Difference (Final Values)|-19.0||||0.1671|TWO_SIDED|95.0|-46.2|8.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||8.2|-46.2|0.1671
70870336|NCT03851705|141225931|SUPERIORITY||Mean Difference (Final Values)|-9.7||||0.1808|TWO_SIDED|95.0|-24.2|4.7||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||4.7|-24.2|0.1808
70870337|NCT03851705|141225933|SUPERIORITY||Mean Difference (Final Values)|-9.6||||0.3077|TWO_SIDED|95.0|-28.3|9.1||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||9.1|-28.3|0.3077
70870338|NCT03851705|141225933|SUPERIORITY||Mean Difference (Final Values)|-9.4||||0.3628|TWO_SIDED|95.0|-30.1|11.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||11.2|-30.1|0.3628
70870339|NCT03851705|141225933|SUPERIORITY||Mean Difference (Final Values)|-6.2||||0.4669|TWO_SIDED|95.0|-23.2|10.8||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||10.8|-23.2|0.4669
70870340|NCT03851705|141225939|SUPERIORITY||Mean Difference (Final Values)|-4.31||||0.6814|TWO_SIDED|95.0|-24.88|16.27|||ANCOVA|||||16.27|-24.88|0.6814
70870341|NCT03851705|141225940|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.8725|TWO_SIDED|95.0|-27.7|23.51|||ANCOVA|||||23.51|-27.70|0.8725
70870342|NCT03851705|141225941|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.9425|TWO_SIDED|95.0|-22.3|20.72|||ANCOVA|||||20.72|-22.30|0.9425
70952789|NCT02683785|141407181|OTHER||Mean Difference (Net)|-0.5||||0.416|TWO_SIDED|95.0|-1.9|0.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented|||0.8|-1.9|0.416
70952790|NCT02683785|141407181|OTHER||Mean Difference (Net)|-1.2||||0.12|TWO_SIDED|95.0|-2.8|0.3||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented|||0.3|-2.8|0.120
70870343|NCT03851705|141225942|SUPERIORITY||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.2|5.2|||Regression, Logistic|||||5.2|0.2|
70870344|NCT00959764|141225953|NON_INFERIORITY_OR_EQUIVALENCE|"Assumed placebo-adjusted effect for both active treatment groups (% increase in BMD)was 1.56% and that the placebo adjusted effect for the rsCT tablets must be at least 0.5 times the placebo adjusted effect for the calcitonin nasal spray (active control treatment group). The null hypothesis to be tested was:~\[Mean(oral) - Mean(placebo)\] - 0.5 x \[Mean(nasal) - Mean(placebo)\] \< 0. Reference Pigeot, et al. 2003"|Mean Difference (Net)|0.77|STANDARD_DEVIATION|2.5||0.002|TWO_SIDED|95.0|0.08|1.45||The P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was \<0.05|ANCOVA|||The overall analysis across groups was an Analysis of Covariance where the study was powered to 80% with an assumption of a standard deviation of 2.5% and a two-sided 5% level of significance. For each treatment group, the BMD at 48 weeks was compared with the BMD at baseline and a % increase was calculated (baseline = 0%). This difference was subjected to the t-test. Two-sided P-value is less than or equal to 0.05 and was not adjusted as multiple comparisons were not done.||1.45|0.08|0.002
70870345|NCT00959764|141225954|NON_INFERIORITY_OR_EQUIVALENCE|Same as for Primary Outcome|Mean Difference (Net)|-21.84|STANDARD_DEVIATION|41.99||0.0006||||||P-value not adjusted for multiple comparisons; a priori threshold for significance was 0.05|ANCOVA|95% confidence interval not calculated||Same as for Primary Outcome||||0.0006
70870346|NCT00959764|141225955|NON_INFERIORITY_OR_EQUIVALENCE|Same as Primary Outcome|Mean Difference (Net)|-18.09|STANDARD_DEVIATION|47.53||0.0012||||||p-value not adjusted for multiple comparisons; a priori threshold for statistical significance was set at 0.05.|ANCOVA||oral calcitonin vs placebo|Same as Primary Outcome||||0.0012
70870347|NCT00692341|141225956|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|88.61|||||TWO_SIDED|90.0|49.2|159.56||||||For mild hepatic impairment, analysis of variance (ANOVA) was used to compare natural log transformed Cmax of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and confidence intervals (CIs) on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||159.56|49.20|
70870348|NCT00692341|141225956|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|127.67|||||TWO_SIDED|90.0|70.9|229.91||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed Cmax of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||229.91|70.90|
70870349|NCT00692341|141225957|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|78.34|||||TWO_SIDED|90.0|39.92|153.75||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed AUC (0 - ∞) of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||153.75|39.92|
70952791|NCT02683785|141407181|OTHER||Mean Difference (Net)|-0.3||||0.687|TWO_SIDED|95.0|-2.1|1.4||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented|||1.4|-2.1|0.687
70952792|NCT02683785|141407182|OTHER||Mean Difference (Net)|-0.2||||0.651|TWO_SIDED|95.0|-1.3|0.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented.|||0.8|-1.3|0.651
70870350|NCT00692341|141225957|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|195.25|||||TWO_SIDED|90.0|99.49|383.18||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed AUC (0 - ∞) of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||383.18|99.49|
70870351|NCT00692341|141225958|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|78.14|||||TWO_SIDED|90.0|38.68|157.82||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed AUClast of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||157.82|38.68|
70870352|NCT00692341|141225958|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|198.9|||||TWO_SIDED|90.0|98.47|401.74||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed AUClast of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||401.74|98.47|
70870353|NCT00692341|141225963|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|73.78|||||TWO_SIDED|90.0|37.4|145.56||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed fu of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||145.56|37.40|
70870354|NCT00692341|141225963|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|100.86|||||TWO_SIDED|90.0|55.58|183.02||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed fu of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||183.02|55.58|
70870355|NCT00692341|141225964|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|91.43|||||TWO_SIDED|90.0|44.75|186.79||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed CLu/F of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||186.79|44.75|
71144947|NCT05546476|141783340|SUPERIORITY||Difference in LS Mean|49.85|||=|0.0189|TWO_SIDED|90.0|10.62|89.08|||MMRM analysis; 1-sided|||Non-Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||89.08|10.62|=0.0189
70870356|NCT00692341|141225964|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|50.78|||||TWO_SIDED|90.0|27.14|95.03||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed CLu/F of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||95.03|27.14|
70870357|NCT00692341|141225965|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|103.09|||||TWO_SIDED|90.0|51.53|206.22||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed Vzu/F of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||206.22|51.53|
70870358|NCT00692341|141225965|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|76.06|||||TWO_SIDED|90.0|41.41|139.73||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed Vzu/F of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||139.73|41.41|
70870359|NCT00692341|141225966|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|109.38|||||TWO_SIDED|90.0|53.54|223.47||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed AUC (0 - ∞)u of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||223.47|53.54|
70870360|NCT00692341|141225966|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|196.92|||||TWO_SIDED|90.0|105.23|368.49||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed AUC (0 - ∞)u of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||368.49|105.23|
70870361|NCT00692341|141225967|SUPERIORITY_OR_OTHER||Adjusted ratio of geometric means|111.65|||||TWO_SIDED|90.0|54.35|229.37||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed AUClastu of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||229.37|54.35|
70952793|NCT02683785|141407182|OTHER||Mean Difference (Net)|-0.7||||0.271|TWO_SIDED|95.0|-1.9|0.5||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented|||0.5|-1.9|0.271
70870362|NCT00692341|141225967|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|200.6|||||TWO_SIDED|90.0|106.68|377.2||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed AUClastu of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||377.20|106.68|
70870363|NCT00692341|141225968|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|106.82|||||TWO_SIDED|90.0|58.22|195.99||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed Cmaxu of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||195.99|58.22|
70870364|NCT00692341|141225968|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|128.76|||||TWO_SIDED|90.0|75.62|219.25||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed Cmaxu of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||219.25|75.62|
70870365|NCT03087643|141226032|OTHER|||||||0.0492|||||||Mixed Models Analysis|||||||0.0492
70870366|NCT03087643|141226033|OTHER|||||||0.0283|||||||Mixed Models Analysis|||||||0.0283
70870367|NCT03087643|141226034|OTHER|||||||0.0321|||||||Mixed Models Analysis|||||||0.0321
70870368|NCT03087643|141226035|OTHER|||||||0.0451|||||||Mixed Models Analysis|||||||0.0451
70870369|NCT03087643|141226036|OTHER|||||||0.0476|||||||Mixed Models Analysis|||||||0.0476
70870370|NCT00113022|141226037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22|STANDARD_ERROR_OF_MEAN|18.867||0.919|TWO_SIDED|95.0|-46.565|51.006||The test reported here examines the main effect for placebo versus drug.|Mixed Models Analysis||A positive value indicates greater depression in the active treatment group compared to placebo.|Per protocol, a linear mixed model with a first order autoregressive covariance structure was used. Baseline was included as a covariate. Drug and visit were main effects with an interaction between them included.||51.006|-46.565|.919
70870371|NCT02083783|141226038|SUPERIORITY||Mean Difference (Final Values)|-14.68|||<|0.0001|TWO_SIDED|95.0|-17.9|11.6|||ANCOVA|||Treatment difference in SKAMP-C scores from baseline to 4 hours postdose.||11.6|-17.9|<0.0001
70870372|NCT02083783|141226039|SUPERIORITY||Mean Difference (Final Values)|38.9|||<|0.0001|TWO_SIDED|95.0|27.3|50.6|||ANCOVA|||p-value for comparison between change from baseline in placebo vs active treatment||50.6|27.3|<0.0001
70870373|NCT00824720|141226065|SUPERIORITY_OR_OTHER||least square mean difference|-0.22|STANDARD_DEVIATION|2.3||0.9737|||||||ANCOVA||Mean difference was calculated as high dose minus placebo.|The alternative hypothesis was that the high dose was different from the placebo.||||0.9737
70870374|NCT00824720|141226065|SUPERIORITY_OR_OTHER||least square mean difference|-1.11|STANDARD_DEVIATION|3.5||0.4711|||||||ANCOVA||The mean difference was calculated as low dose minus placebo.|The alternative hypothesis is that the low dose was different from placebo.||||0.4711
70870375|NCT02849678|141226133|NON_INFERIORITY|A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups.||||||0.148|||||||t-test, 1 sided|||||||0.148
70870376|NCT02849678|141226135|NON_INFERIORITY|A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups.||||||0.636|||||||t-test, 1 sided|||||||.636
70870377|NCT02849678|141226137|NON_INFERIORITY|A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups.||||||0.193||||||Hydromorphone consumption (mg) in Post-Anesthesia Care Unit (PACU)|t-test, 2 sided|||||||0.193
70870378|NCT02849678|141226137|NON_INFERIORITY|A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups.||||||0.635||||||Hydromorphone consumption (mg) in PACU versus at 24 hours versus 48 hours|ANOVA|||||||0.635
70870379|NCT02849678|141226138|NON_INFERIORITY|A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups.||||||0.063|||||||ANOVA|Local Anesthetic Consumption through para-vertebral catheters in PACU vs. at 24 hours vs. 48 hours||||||0.063
70870380|NCT02899793|141226157|SUPERIORITY|||||||0.024|||||||Fisher Exact|||Subgroup difference in ORRs||||0.024
70870381|NCT03310021|141226161|SUPERIORITY||Hodges lehman Location shift|-65.5||||0.0275|TWO_SIDED|95.0|-78.0|-58.0|||2-sided Wilcoxon Rank Sum|||||-58.00|-78.00|0.0275
70870382|NCT03310021|141226161|SUPERIORITY||Hodges lehman Location shift|-61.0||||0.025|TWO_SIDED|95.0|-65.0|-44.0|||2-sided Wilcoxon Rank Sum|||||-44.00|-65.00|0.025
70870383|NCT03310021|141226161|SUPERIORITY||Hodges lehman Location shift|-32.5||||0.0136|TWO_SIDED|95.0|-47.0|-9.0|||2-sided Wilcoxon Rank Sum|||||-9.00|-47.00|0.0136
70870384|NCT03310021|141226161|SUPERIORITY||Hodges lehman Location shift|-36.5||||0.0136|TWO_SIDED|95.0|-62.0|-9.0|||2-sided Wilcoxon Rank Sum|||||-9.00|-62.00|0.0136
70870385|NCT03310021|141226161|SUPERIORITY||Hodges lehman Location shift|-59.0||||0.025|TWO_SIDED|95.0|-70.0|-38.0|||2-sided Wilcoxon Rank Sum|||||-38.00|-70.00|0.025
70870386|NCT03310021|141226161|SUPERIORITY||Hodges lehman Location shift|-66.0||||0.0119|TWO_SIDED|95.0|-68.0|-61.0|||2-sided Wilcoxon Rank Sum|||||-61.00|-68.00|0.0119
70870387|NCT03310021|141226161|SUPERIORITY||Hodges lehman Location shift|-15.5||||0.2667|TWO_SIDED|95.0|-38.0|17.0|||2-sided Wilcoxon Rank Sum|||||17.00|-38.00|0.2667
70870388|NCT03310021|141226161|SUPERIORITY||Hodges lehman Location shift|-68.0||||0.0238|TWO_SIDED|95.0|-74.0|-59.0|||2-sided Wilcoxon Rank Sum|||||-59.00|-74.00|0.0238
70870389|NCT03310021|141226161|SUPERIORITY||Hodges lehman Location shift|-56.5||||0.0007|TWO_SIDED|95.0|-65.0|-39.0|||2-sided Wilcoxon Rank Sum|||||-39.00|-65.00|0.0007
70870390|NCT03310021|141226161|SUPERIORITY||Hodges lehman Location shift|-35.0||||0.0121|TWO_SIDED|95.0|-53.0|-24.0|||2-sided Wilcoxon Rank Sum|||||-24.00|-53.00|0.0121
70870391|NCT03310021|141226162|SUPERIORITY||Hodges lehman Location shift|-80.0||||0.0256|TWO_SIDED|95.0|-83.0|-77.0|||2-sided Wilcoxon Rank Sum|||||-77.00|-83.00|0.0256
70870392|NCT03310021|141226162|SUPERIORITY||Hodges lehman Location shift|-79.5||||0.025|TWO_SIDED|95.0|-97.0|-67.0|||2-sided Wilcoxon Rank Sum|||||-67.00|-97.00|0.025
70870393|NCT03310021|141226162|SUPERIORITY||Hodges lehman Location shift|-37.0||||0.074|TWO_SIDED|95.0|-66.0|5.0|||2-sided Wilcoxon Rank Sum|||||5.00|-66.00|0.074
70870394|NCT03310021|141226162|SUPERIORITY||Hodges lehman Location shift|-10.5||||0.1066|TWO_SIDED|95.0|-59.0|10.0|||2-sided Wilcoxon Rank Sum|||||10.00|-59.00|0.1066
70870395|NCT03310021|141226162|SUPERIORITY||Hodges lehman Location shift|-84.0||||0.0219|TWO_SIDED|95.0|-87.0|-71.0|||2-sided Wilcoxon Rank Sum|||||-71.00|-87.00|0.0219
70870396|NCT03310021|141226162|SUPERIORITY||Hodges lehman Location shift|-78.0||||0.0262|TWO_SIDED|95.0|-83.0|-74.0|||2-sided Wilcoxon Rank Sum|||||-74.0|-83.00|0.0262
70870397|NCT03310021|141226162|SUPERIORITY||Hodges lehman Location shift|-50.0||||0.0412|TWO_SIDED|95.0|-65.0|0.0|||2-sided Wilcoxon Rank Sum|||||0.00|-65.00|0.0412
70870398|NCT03310021|141226162|SUPERIORITY||Hodges lehman Location shift|-89.5||||0.0269|TWO_SIDED|95.0|-93.0|-77.0|||2-sided Wilcoxon Rank Sum|||||-77.00|-93.00|0.0269
70870399|NCT03310021|141226162|SUPERIORITY||Hodges lehman Location shift|-84.0||||0.0026|TWO_SIDED|95.0|-86.0|-69.0|||2-sided Wilcoxon Rank Sum|||||-69.00|-86.00|0.0026
70870400|NCT03310021|141226162|SUPERIORITY||Hodges lehman Location shift|-65.0||||0.0181|TWO_SIDED|95.0|-76.0|-57.0|||2-sided Wilcoxon Rank Sum|||||-57.00|-76.00|0.0181
70870401|NCT03310021|141226163|SUPERIORITY||Hodges lehman Location shift|-81.06||||0.0282|TWO_SIDED|95.0|-92.99|-71.96|||2-sided Wilcoxon Rank Sum|||||-71.96|-92.99|0.0282
70870402|NCT03310021|141226163|SUPERIORITY||Hodges lehman Location shift|-69.15||||0.0282|TWO_SIDED|95.0|-96.91|-48.64|||2-sided Wilcoxon Rank Sum|||||-48.64|-96.91|0.0282
70870403|NCT03310021|141226163|SUPERIORITY||Hodges lehman Location shift|-57.39||||0.0085|TWO_SIDED|95.0|-72.07|-40.03|||2-sided Wilcoxon Rank Sum|||||-40.03|-72.07|0.0085
70870404|NCT03310021|141226163|SUPERIORITY||Hodges lehman Location shift|-54.96||||0.0085|TWO_SIDED|95.0|-80.42|-25.5|||2-sided Wilcoxon Rank Sum|||||-25.50|-80.42|0.0085
70870405|NCT03310021|141226163|SUPERIORITY||Hodges lehman Location shift|-100.25||||0.0282|TWO_SIDED|95.0|-133.08|-84.48|||2-sided Wilcoxon Rank Sum|||||-84.48|-133.08|0.0282
70870406|NCT03310021|141226163|SUPERIORITY||Hodges lehman Location shift|-79.87||||0.0282|TWO_SIDED|95.0|-86.36|-65.74|||2-sided Wilcoxon Rank Sum|||||-65.74|-86.36|0.0282
70870407|NCT03310021|141226163|SUPERIORITY||Hodges lehman Location shift|-65.02||||0.0085|TWO_SIDED|95.0|-89.54|-39.17|||2-sided Wilcoxon Rank Sum|||||-39.17|-89.54|0.0085
70870408|NCT03310021|141226163|SUPERIORITY||Hodges lehman Location shift|-91.29||||0.0282|TWO_SIDED|95.0|-128.88|-60.83|||2-sided Wilcoxon Rank Sum|||||-60.83|-128.88|0.0282
70870409|NCT03310021|141226163|SUPERIORITY||Hodges lehman Location shift|-81.49||||0.0034|TWO_SIDED|95.0|-91.05|-65.96|||2-sided Wilcoxon Rank Sum|||||-65.96|-91.05|0.0034
70870410|NCT03310021|141226163|SUPERIORITY||Hodges lehman Location shift|-58.47||||0.0189|TWO_SIDED|95.0|-110.86|-46.12|||2-sided Wilcoxon Rank Sum|||||-46.12|-110.86|0.0189
70870411|NCT03310021|141226164|SUPERIORITY||Hodges lehman Location shift|-59.39||||0.0282|TWO_SIDED|95.0|-66.48|-52.62|||2-sided Wilcoxon Rank Sum|||||-52.62|-66.48|0.0282
70870412|NCT03310021|141226164|SUPERIORITY||Hodges lehman Location shift|-59.26||||0.0282|TWO_SIDED|95.0|-70.34|-26.94|||2-sided Wilcoxon Rank Sum|||||-26.94|-70.34|0.0282
70870413|NCT03310021|141226164|SUPERIORITY||Hodges lehman Location shift|-36.76||||0.0085|TWO_SIDED|95.0|-46.14|-29.76|||2-sided Wilcoxon Rank Sum|||||-29.76|-46.14|0.0085
70870414|NCT03310021|141226164|SUPERIORITY||Hodges lehman Location shift|-36.82||||0.0085|TWO_SIDED|95.0|-55.81|-20.46|||2-sided Wilcoxon Rank Sum|||||-20.46|-55.81|0.0085
70870415|NCT03310021|141226164|SUPERIORITY||Hodges lehman Location shift|-61.67||||0.0282|TWO_SIDED|95.0|-75.82|-43.78|||2-sided Wilcoxon Rank Sum|||||-43.78|-75.82|0.0282
70870416|NCT03310021|141226164|SUPERIORITY||Hodges lehman Location shift|-67.63||||0.0282|TWO_SIDED|95.0|-77.4|-61.99|||2-sided Wilcoxon Rank Sum|||||-61.99|-77.40|0.0282
70870417|NCT03310021|141226164|SUPERIORITY||Hodges lehman Location shift|-40.33||||0.0085|TWO_SIDED|95.0|-59.77|-11.17|||2-sided Wilcoxon Rank Sum|||||-11.17|-59.77|0.0085
70870418|NCT03310021|141226164|SUPERIORITY||Hodges lehman Location shift|-59.18||||0.0282|TWO_SIDED|95.0|-101.02|-48.14|||2-sided Wilcoxon Rank Sum|||||-48.14|-101.02|0.0282
70870419|NCT03310021|141226164|SUPERIORITY||Hodges lehman Location shift|-54.63||||0.0027|TWO_SIDED|95.0|-59.14|-41.19|||2-sided Wilcoxon Rank Sum|||||-41.19|-59.14|0.0027
70870420|NCT03310021|141226164|SUPERIORITY||Hodges lehman Location shift|-38.14||||0.0189|TWO_SIDED|95.0|-65.78|-15.37|||2-sided Wilcoxon Rank Sum|||||-15.37|-65.78|0.0189
70870421|NCT03310021|141226165|SUPERIORITY||Hodges lehman Location shift|965.09||||0.0282|TWO_SIDED|95.0|474.48|1377.35|||2-sided Wilcoxon Rank Sum|||||1377.35|474.48|0.0282
70870422|NCT03310021|141226165|SUPERIORITY||Hodges lehman Location shift|1127.29||||0.0282|TWO_SIDED|95.0|769.46|1575.02|||2-sided Wilcoxon Rank Sum|||||1575.02|769.46|0.0282
70870423|NCT03310021|141226165|SUPERIORITY||Hodges lehman Location shift|574.89||||0.0085|TWO_SIDED|95.0|307.65|1175.28|||2-sided Wilcoxon Rank Sum|||||1175.28|307.65|0.0085
70870424|NCT03310021|141226165|SUPERIORITY||Hodges lehman Location shift|715.34||||0.0085|TWO_SIDED|95.0|535.38|836.4|||2-sided Wilcoxon Rank Sum|||||836.40|535.38|0.0085
70870425|NCT03310021|141226165|SUPERIORITY||Hodges lehman Location shift|1141.17||||0.0282|TWO_SIDED|95.0|964.03|1736.78|||2-sided Wilcoxon Rank Sum|||||1736.78|964.03|0.0282
70870426|NCT03310021|141226165|SUPERIORITY||Hodges lehman Location shift|1198.83||||0.0282|TWO_SIDED|95.0|988.82|1670.3|||2-sided Wilcoxon Rank Sum|||||1670.30|988.82|0.0282
70870427|NCT03310021|141226165|SUPERIORITY||Hodges lehman Location shift|721.21||||0.0085|TWO_SIDED|95.0|585.92|1108.92|||2-sided Wilcoxon Rank Sum|||||1108.92|585.92|0.0085
70870428|NCT03310021|141226165|SUPERIORITY||Hodges lehman Location shift|1204.62||||0.0282|TWO_SIDED|95.0|1001.72|1471.45|||2-sided Wilcoxon Rank Sum|||||1471.45|1001.72|0.0282
70870429|NCT03310021|141226165|SUPERIORITY||Hodges lehman Location shift|1180.5||||0.0027|TWO_SIDED|95.0|857.21|1296.02|||2-sided Wilcoxon Rank Sum|||||1296.02|857.21|0.0027
70870430|NCT03310021|141226165|SUPERIORITY||Hodges lehman Location shift|976.59||||0.0189|TWO_SIDED|95.0|585.99|1498.37|||2-sided Wilcoxon Rank Sum|||||1498.37|585.99|0.0189
70870431|NCT03310021|141226166|SUPERIORITY||Hodges lehman Location shift|826.9||||0.0282|TWO_SIDED|95.0|505.4|1362.11|||2-sided Wilcoxon Rank Sum|||||1362.11|505.40|0.0282
70870432|NCT03310021|141226166|SUPERIORITY||Hodges lehman Location shift|1125.7||||0.0282|TWO_SIDED|95.0|873.87|1552.77|||2-sided Wilcoxon Rank Sum|||||1552.77|873.87|0.0282
70870433|NCT03310021|141226166|SUPERIORITY||Hodges lehman Location shift|538.84||||0.0085|TWO_SIDED|95.0|291.2|1077.46|||2-sided Wilcoxon Rank Sum|||||1077.46|291.20|0.0085
70870434|NCT03310021|141226166|SUPERIORITY||Hodges lehman Location shift|687.57||||0.0085|TWO_SIDED|95.0|500.92|902.73|||2-sided Wilcoxon Rank Sum|||||902.73|500.92|0.0085
70870435|NCT03310021|141226166|SUPERIORITY||Hodges lehman Location shift|1012.45||||0.0282|TWO_SIDED|95.0|859.08|1352.05|||2-sided Wilcoxon Rank Sum|||||1352.05|859.08|0.0282
70870436|NCT03310021|141226166|SUPERIORITY||Hodges lehman Location shift|1057.27||||0.0282|TWO_SIDED|95.0|818.96|1634.3|||2-sided Wilcoxon Rank Sum|||||1634.30|818.96|0.0282
70870437|NCT03310021|141226166|SUPERIORITY||Hodges lehman Location shift|630.81||||0.0085|TWO_SIDED|95.0|421.78|1124.28|||2-sided Wilcoxon Rank Sum|||||1124.28|421.78|0.0085
70870438|NCT03310021|141226166|SUPERIORITY||Hodges lehman Location shift|925.84||||0.0282|TWO_SIDED|95.0|663.74|1216.28|||2-sided Wilcoxon Rank Sum|||||1216.28|663.74|0.0282
70870439|NCT03310021|141226166|SUPERIORITY||Hodges lehman Location shift|871.11||||0.0027|TWO_SIDED|95.0|631.67|1051.06|||2-sided Wilcoxon Rank Sum|||||1051.06|631.67|0.0027
70870440|NCT03310021|141226166|SUPERIORITY||Hodges lehman Location shift|874.44||||0.0189|TWO_SIDED|95.0|637.25|1412.21|||2-sided Wilcoxon Rank Sum|||||1412.21|637.25|0.0189
70870441|NCT02002091|141226184|OTHER|||||||0.706|||||||Chi-squared|||||||0.706
70870442|NCT02002091|141226185|OTHER|||||||0.346|||||||Chi-squared|||||||0.346
70870443|NCT02002091|141226186|OTHER|||||||0.123|||||||Mantel Haenszel|||||||0.123
70870444|NCT02002091|141226187|OTHER|||||||0.968|||||||Chi-squared, Corrected|||||||0.968
70870445|NCT02002091|141226188|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||||||The threshold for statistical significance for P-Value is \<0.05|Fisher Exact|||||||0.004
70870446|NCT02002091|141226189|SUPERIORITY_OR_OTHER_LEGACY|||||||0.988|||||||Fisher Exact|||||||0.988
70870447|NCT02002091|141226190|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038|||||||Fisher Exact|||||||0.038
70870448|NCT02002091|141226192|SUPERIORITY_OR_OTHER_LEGACY|||||||0.917|||||||Chi-squared, Corrected|||||||0.917
70870449|NCT02002091|141226193|SUPERIORITY_OR_OTHER_LEGACY|||||||0.816|||||||Chi-squared, Corrected|||||||0.816
70870450|NCT02002091|141226194|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||||||Statistical significance : p\< 0.05|Fisher Exact|||||||0.008
70870451|NCT02002091|141226196|OTHER|||||||0.025||||||The threshold of statistical difference is P-value \< 0.05|Chi-squared, Corrected|||||||0.025
70870452|NCT02002091|141226199|OTHER|||||||0.059||||||the threshold for statistical significance used is P-value \<0.05|Fisher Exact|||||||0.059
70870453|NCT03385564|141226231|OTHER|Percentage of patients with CRR at Week 52 without renal flare were analysed using a logistic regression model. Factors in the model included treatment and the covariates: race (Asian versus (vs.) non-Asian) and proteinuria \<3 gram (g)/day vs. ≥3 g/day (or Urine protein (UP)/ Urine creatinine (UC) \<3 vs. UP/UC ≥3) at screening.|Difference|-5.68||||0.7957|TWO_SIDED|80.0|-34.192|22.825|||Regression, Logistic||The difference was calculated as value from BI 120 milligrams group minus value from Placebo group. Confidence intervals calculated using the delta method.|||22.825|-34.192|0.7957
70870454|NCT03385564|141226231|OTHER|Percentage of patients with CRR at Week 52 without renal flare were analysed using a logistic regression model. Factors in the model included treatment and the covariates: race (Asian versus (vs.) non-Asian) and proteinuria \<3 gram (g)/day vs. ≥3 g/day (or Urine protein (UP)/ Urine creatinine (UC) \<3 vs. UP/UC ≥3) at screening.|Difference|-9.37||||0.5811|TWO_SIDED|80.0|-31.178|12.44|||Regression, Logistic||The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the delta method.|||12.440|-31.178|0.5811
70870455|NCT03385564|141226231|OTHER|Percentage of patients with CRR at Week 52 without renal flare were analysed using a logistic regression model. Factors in the model included treatment and the covariates: race (Asian versus (vs.) non-Asian) and proteinuria \<3 gram (g)/day vs. ≥3 g/day (or Urine protein (UP)/ Urine creatinine (UC) \<3 vs. UP/UC ≥3) at screening.|Difference|1.97||||0.8972|TWO_SIDED|80.0|-17.534|21.48|||Regression, Logistic||The difference was calculated as value from BI 240 milligrams group minus value from Placebo group. Confidence intervals calculated using the delta method.|||21.480|-17.534|0.8972
70870456|NCT03385564|141226232|OTHER||Difference|-9.14||||0.825|TWO_SIDED|80.0|-32.83|17.02|||Barnard test||The difference was calculated as value from BI 120 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||17.02|-32.83|0.8250
70870457|NCT03385564|141226232|OTHER||Difference|-21.23||||0.2562|TWO_SIDED|80.0|-39.44|0.51|||Barnard test||The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||0.51|-39.44|0.2562
70870458|NCT03385564|141226232|OTHER||Difference|-2.0||||0.9632|TWO_SIDED|80.0|-20.45|16.62|||Barnard test||The difference was calculated as value from BI 240 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||16.62|-20.45|0.9632
70870459|NCT03385564|141226233|OTHER||Difference|-2.86||||0.9275|TWO_SIDED|80.0|-28.58|21.1|||Barnard test||The difference was calculated as value from BI 120 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||21.10|-28.58|0.9275
70870460|NCT03385564|141226233|OTHER||Difference|-10.0||||0.6064|TWO_SIDED|80.0|-29.9|10.64|||Barnard test||The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||10.64|-29.90|0.6064
70870461|NCT03385564|141226233|OTHER||Difference|0.0|||||TWO_SIDED|80.0|-18.37|18.07|||||The difference was calculated as value from BI 240 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||18.07|-18.37|
70870462|NCT03385564|141226234|OTHER||Difference|3.73||||0.9119|TWO_SIDED|80.0|-20.53|29.6|||Barnard test||The difference was calculated as value from BI 120 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||29.60|-20.53|0.9119
70870463|NCT03385564|141226234|OTHER||Difference|3.73||||0.851|TWO_SIDED|80.0|-16.58|24.31|||Barnard test||The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||24.31|-16.58|0.8510
70952794|NCT02683785|141407182|OTHER||Mean Difference (Net)|-0.9||||0.186|TWO_SIDED|95.0|-2.2|0.4||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented|||0.4|-2.2|0.186
70952795|NCT02683785|141407182|OTHER||Mean Difference (Net)|-1.1||||0.109|TWO_SIDED|95.0|-2.4|0.2||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented|||0.2|-2.4|0.109
70952796|NCT01346072|141407203|SUPERIORITY|||||||0.853|||||||Wilcoxon Two-Sample Test|Wilcoxon Two Sample Test was used with Exact Test two sided p value reported||||||0.853
70952797|NCT01346072|141407204|SUPERIORITY|||||||0.035|||||||Wilcoxon Two-Sample Test|Wilcoxon Two Sample Test was used with Exact Test two sided p value reported||||||0.035
70952798|NCT02233803|141407205|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority (NI) is demonstrated as the lower limit of CI for the difference is greater than the pre-specified NI margin of -1.25ML. The lower limit of the 95% CI for the treatment difference (NEUMOTEROL 400 -Symbicort Forte) was greater than the pre-specified non-inferiority margin of -1.25 mL.|Difference of LS means|0.044|||||TWO_SIDED|95.0|-0.008|0.096||||||Sample size calculations are based on the primary efficacy endpoint (change from baseline in trough FEV1 at day 29). Assuming a within-subject standard deviation of 210 mL, 168 completed subjects are required to demonstrate the non-inferiority of BFF 400/12 mcg SINGLE CAPSULE INHALER and BFF 320/9 mcg TURBUHALER BID, assuming a true difference of -50 mL with 90% power and a 2.5% one-sided significance level. The pre-specified NI margin is set at -1.25mL.||0.096|-0.008|
70870464|NCT03385564|141226234|OTHER||Difference|16.43||||0.3498|TWO_SIDED|80.0|-3.53|34.73|||Barnard test||The difference was calculated as value from BI 240 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||34.73|-3.53|0.3498
70870465|NCT03385564|141226235|OTHER||Difference|5.43||||0.7921|TWO_SIDED|80.0|-10.19|23.57|||Barnard test||The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||23.57|-10.19|0.7921
70870466|NCT03385564|141226237|OTHER||Difference|32.0||||0.1016|TWO_SIDED|80.0|10.28|44.74|||Barnard test||The difference was calculated as value from BI 120 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||44.74|10.28|0.1016
70870467|NCT03385564|141226237|OTHER||Difference|-3.71||||0.8323|TWO_SIDED|80.0|-23.79|15.29|||Barnard test||The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||15.29|-23.79|0.8323
70870468|NCT03385564|141226237|OTHER||Difference|7.0||||0.6247|TWO_SIDED|80.0|-10.5|23.31|||Barnard test||The difference was calculated as value from BI 240 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||23.31|-10.50|0.6247
70952799|NCT02233803|141407206|SUPERIORITY_OR_OTHER||Difference of LS means|0.98|||||TWO_SIDED|95.0|0.576|1.384||||||||1.384|0.576|
70870469|NCT00622284|141226268|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis of non-inferiority is rejected if the upper bound of the two-sided 97.5% confidence interval is less than 0.35%. Superiority testing was not part of the pre-specified Week 52 confirmatory analysis.|Least Squares Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.04||0.0005||97.5|0.13|0.31||Due to multiple testing of the primary endpoints at weeks 52 and 104 a Bonferroni correction was applied and 97.5% confidence intervals produced. This 1-sided p-value for non-inferiority should be compared to the 1-sided threshold of 0.0125.|ANCOVA|||Linagliptin versus Glimepiride||0.31|0.13|0.0005
70870470|NCT00622284|141226269|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis of non-inferiority is rejected if the upper bound of the two-sided 97.5% confidence interval is less than 0.35%. However, superiority testing is only applicable if the Linagliptin decrease is greater than that in Glimepiride.|Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.05||0.0004||97.5|0.09|0.3||This 1-sided p-value should be compared to the 1-sided threshold of 0.0125 for non-inferiority. Due to the pre-specified hierarchial approach, further confirmatory analysis on the Week24 endpoints is only applicable if superiority is already met.|ANCOVA|||Linagliptin versus Glimepiride||0.30|0.09|0.0004
70870471|NCT00622284|141226270|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001||97.5|-2.91|-2.09||This Week52 key secondary endpoint was only to be tested (2-sided threshold of 0.025 to allow for multiple testing within a visit) if the Week52 primary hypothesis was rejected.|ANCOVA|||Linagliptin versus Glimepiride||-2.09|-2.91|<0.0001
70870472|NCT00622284|141226271|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.68|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001||97.5|-3.17|-2.19||Due to testing of multiple endpoints within a visit a sequential testing strategy (at 2-sided threshold of 0.025) was applied to the key secondary endpoints.|ANCOVA|||Linagliptin versus Glimepiride||-2.19|-3.17|<0.0001
70870473|NCT00622284|141226272|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||This key secondary endpoint was only to be tested (comparing to a 2-sided threshold of 0.025) if the Week52 body weight change from baseline was confirmatory.|Cochran-Mantel-Haenszel|||Linagliptin versus Glimepiride||||<0.0001
70952800|NCT02233803|141407207|SUPERIORITY_OR_OTHER||Difference of LS means|0.6|||||TWO_SIDED|95.0|0.1|1.1||||||||1.1|0.1|
70952801|NCT03635099|141407208|OTHER||Risk Difference (RD)|5.0||||0.3091|TWO_SIDED|95.0|-1.8|11.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||11.8|-1.8|0.3091
70952802|NCT03635099|141407208|OTHER||Risk Difference (RD)|7.7||||0.203|TWO_SIDED|95.0|-0.7|16.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||16.1|-0.7|0.2030
70952803|NCT03635099|141407208|OTHER||Risk Difference (RD)|10.3||||0.138|TWO_SIDED|95.0|0.7|19.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||19.8|0.7|0.1380
70952804|NCT03635099|141407208|OTHER||Risk Difference (RD)|30.0||||0.0062|TWO_SIDED|95.0|15.8|44.2|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||44.2|15.8|0.0062
70870474|NCT00622284|141226273|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Due to testing of multiple endpoints within a visit a sequential testing strategy (at 2-sided threshold of 0.025) was applied to the key secondary endpoints.|Cochran-Mantel-Haenszel|||Linagliptin versus Glimepiride||||<0.0001
70870475|NCT00622284|141226274|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.84|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001||95.0|3.51|10.16|||ANCOVA|||Linagliptin versus Glimepiride||10.16|3.51|<0.0001
70870476|NCT00622284|141226275|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.38|STANDARD_ERROR_OF_MEAN|1.97||0.0012||95.0|2.51|10.25|||ANCOVA|||Linagliptin versus Glimepiride||10.25|2.51|0.0012
70870477|NCT00622284|141226276|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.625||||0.0004||95.0|0.482|0.811|||Regression, Logistic|The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.||Linagliptin versus Glimepiride||0.811|0.482|0.0004
70870478|NCT00622284|141226277|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.654||||0.003||95.0|0.494|0.866|||Regression, Logistic|The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.||Linagliptin versus Glimepiride||0.866|0.494|0.0030
70870479|NCT00622284|141226278|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.648||||0.0025||95.0|0.489|0.859|||Regression, Logistic|The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.||Linagliptin versus Glimepiride||0.859|0.489|0.0025
70870480|NCT00622284|141226279|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.689||||0.024||95.0|0.498|0.952|||Regression, Logistic|The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.||Linagliptin versus Glimepiride||0.952|0.498|0.0240
70870481|NCT00622284|141226280|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.0018||95.0|0.56|0.875|||Regression, Logistic|The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.||Linagliptin versus Glimepiride||0.875|0.560|0.0018
70952805|NCT03635099|141407208|OTHER||Risk Difference (RD)|25.6|||||TWO_SIDED|95.0|12.5|38.6|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||38.6|12.5|
70952806|NCT03635099|141407208|OTHER||Risk Difference (RD)|23.8|||||TWO_SIDED|95.0|10.9|36.7|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||36.7|10.9|
71144948|NCT05546476|141783340|SUPERIORITY||Difference in LS Mean|8.51|||=|0.1302|TWO_SIDED|90.0|-4.0|21.03|||MMRM analysis; 1-sided|||Moderate to Vigorous Physical Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||21.03|-4.00|=0.1302
70952807|NCT03635099|141407208|OTHER|First the response rate of PASI 75 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline PASI score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0004||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Linear model fit.|||||||0.0004
71144949|NCT05546476|141783340|SUPERIORITY||Difference in LS Mean|4.49|||=|0.278|TWO_SIDED|90.0|-8.18|17.16|||MMRM analysis; 1-sided|||Moderate to Vigorous Physical Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||17.16|-8.18|=0.2780
70870482|NCT00622284|141226281|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-9.47|STANDARD_ERROR_OF_MEAN|5.77||0.0918||95.0|-21.07|1.59|||ANCOVA|||Linagliptin versus Glimepiride||1.59|-21.07|0.0918
70870483|NCT00457301|141226319|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.1||0.05||95.0|||||ANCOVA|||Sample size was calculated based on the EQ-5D index score. To compare two independent means for a parallel trial design, 100 patients in each group were needed to detect a clinically important difference (CID) in EQ-5D index score (CID = 0.10, SD = 0.25) with a 5% probability of Type I error and 80% power.||||0.05
70870484|NCT00457301|141226320|SUPERIORITY_OR_OTHER_LEGACY|||||||0.34||95.0|||||ANCOVA|||ANCOVA adjuusting for baseline HADS anxiety scores||||0.34
70870485|NCT00457301|141226320|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0|||||ANCOVA|||ANCOVA adjusting for baseline HADS depression scores.||||0.55
70870486|NCT00457301|141226321|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.79|STANDARD_ERROR_OF_MEAN|0.23||0.001||95.0|||||ANCOVA|||||||0.001
70870487|NCT00457301|141226322|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.46||95.0|||||ANCOVA|||Sample size was calculated based on the EQ-5D index score. To compare two independent means for a parallel trial design, 100 patients in each group were needed to detect a clinically important difference (CID) in EQ-5D index score (CID = 0.10, SD = 0.25) with a 5% probability of Type I error and 80% power.||||0.46
70870488|NCT01217801|141226347|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|93.77||||0.05|TWO_SIDED|90.0|89.15|98.63|||Regression, Linear|||Linear mixed effect model, log transformed AUC, LSMeans for treatment Film and Tablet, the difference between the LSMeans and 90%CI calculated and transformed to geometric means, ratio estimates and 90%CI||98.63|89.15|0.05
70870489|NCT00291577|141226394|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|98.89||||||90.0|80.34|121.73|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|SU011248 C1D2 vs C2D3. Due to the exploratory nature of the study, no statistical hypothesis testing was done since the primary purpose was to assess the tolerability of the combination of SU011248 with docetaxel.||121.73|80.34|
70870490|NCT00291577|141226394|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|81.96||||||90.0|59.76|112.41|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|SU012662 C1D2 vs C2D3||112.41|59.76|
70870491|NCT00291577|141226394|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|97.81||||||90.0|80.44|118.94|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|Total drug C1D2 vs C2D3||118.94|80.44|
70870492|NCT00291577|141226395|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|101.23||||||90.0|82.75|123.83|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|SU011248 C1D2 vs C2D3||123.83|82.75|
70870493|NCT00291577|141226395|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|81.72||||||90.0|62.4|107.04|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|SU012662 C1D2 vs C2D3||107.04|62.40|
70870494|NCT00291577|141226395|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|100.0||||||90.0|82.95|120.56|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|Total drug C1D2 vs C2D3||120.56|82.95|
70870495|NCT00291577|141226399|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|99.18||||||90.0|78.73|124.95|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|C1D1 vs C2D1||124.95|78.73|
70870496|NCT00291577|141226400|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|94.98||||||90.0|78.73|114.58|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|C1D1 vs C2D1||114.58|78.73|
70870497|NCT00291577|141226402|SUPERIORITY_OR_OTHER||rate (percent)|73.7||||||95.0|48.8|90.9|||||Two-sided Confidence Interval (CI) (%) from exact method based on F distribution.|Overall confirmed objective response rate (CR + PR)||90.9|48.8|
70870498|NCT00291577|141226403|SUPERIORITY_OR_OTHER||rate (percent)|89.5||||||95.0|66.9|98.7|||||Two-sided CI (%) from exact method based on F distribution.|Clinical Benefit Rate (CR + PR + SD \> = 24 weeks)||98.7|66.9|
70952808|NCT03635099|141407208|OTHER|First the response rate of PASI 75 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline PASI score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0012||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Logistic model fit.|Model assumption: 10% of the maximum effect is achieved at 25 mg and 80% of the maximum effect is achieved at 100 mg.||||||0.0012
70870499|NCT00291577|141226405|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|95.57||||||90.0|79.9|114.32|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|C1D1 vs C2D1||114.32|79.90|
70870500|NCT00291577|141226406|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|112.39||||||90.0|81.05|155.85|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|C1D1 vs C2D1||155.85|81.05|
70870501|NCT00291577|141226407|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|95.79||||||90.0|79.82|114.96|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|C1D1 vs C2D1||114.96|79.82|
70870502|NCT04967443|141226409|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|102.1|||||TWO_SIDED|90.0|96.14|108.43|||Mixed Models Analysis|||Test: Prazosin HCL 1x2 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)||108.43|96.14|
70870503|NCT04967443|141226409|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|104.87|||||TWO_SIDED|90.0|98.68|111.44|||Mixed Models Analysis|||Test: Prazosin HCL 2x1 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)||111.44|98.68|
70870504|NCT04967443|141226409|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|104.45|||||TWO_SIDED|90.0|99.58|109.55|||Mixed Models Analysis|||Test: Prazosin HCL 1x5 mg (Ascoli); Reference: Prazosin HCL 1x5 mg (Barceloneta)||109.55|99.58|
70870505|NCT04967443|141226410|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|113.96|||||TWO_SIDED|90.0|102.79|126.34|||Mixed Models Analysis|||Test: Prazosin HCL 1x2 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)||126.34|102.79|
70870506|NCT04967443|141226410|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|126.83|||||TWO_SIDED|90.0|114.32|140.7|||Mixed Models Analysis|||Test: Prazosin HCL 2x1 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)||140.70|114.32|
70870507|NCT04967443|141226410|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|118.07|||||TWO_SIDED|90.0|106.46|130.94|||Mixed Models Analysis|||Test: Prazosin HCL 1x5 mg (Ascoli); Reference: Prazosin HCL 1x5 mg (Barceloneta)||130.94|106.46|
70870508|NCT04967443|141226411|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|100.91|||||TWO_SIDED|90.0|94.92|107.27|||Mixed Models Analysis|||Test: Prazosin HCL 1x2 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)||107.27|94.92|
70870509|NCT04967443|141226411|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|102.08|||||TWO_SIDED|90.0|95.97|108.57|||Mixed Models Analysis|||Test: Prazosin HCL 2x1 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)||108.57|95.97|
70870510|NCT04967443|141226411|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|104.04|||||TWO_SIDED|90.0|99.09|109.23|||Mixed Models Analysis|||Test: Prazosin HCL 1x5 mg (Ascoli); Reference: Prazosin HCL 1x5 mg (Barceloneta)||109.23|99.09|
70870511|NCT04502693|141226416|OTHER|Effectiveness of rMenB+OMV NZ vaccine is demonstrated if the LL of the 2-sided 97.5% CI for Vaccine Effectiveness (VE) against the selected strain panel between the MenB\_0\_2\_6 and the ACWY groups is above 65%. VE is defined as 1- Risk Ratio (RR) = (1- percentage of samples without bactericidal serum activity at 1:4 dilution in MenB group / percentage of samples without bactericidal serum activity at 1:4 dilution in the ACWY group) x100 percentage.|VE (Vaccine Effectiveness)|83.2|||||TWO_SIDED|97.5|81.9|84.4||||||To demonstrate the effectiveness of the rMenB+OMV NZ vaccine against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains as measured by bactericidal activity using enc-hSBA at 1 month after the 3-dose (0,2,6-months) schedule in MenB\_0\_2\_6 group when compared to 1 month after the MenACWY dose in the ACWY group.||84.4|81.9|
70870512|NCT04502693|141226416|OTHER|"Effectiveness of rMenB+OMV NZ vaccine is demonstrated if the LL of the 2-sided 97.5% CI for VE against the selected strain panel between the MenB\_0\_ 6 and the ACWY groups is above 65%.~VE is defined as 1- RR = (1- percentage of samples without bactericidal serum activity at 1:4 dilution in MenB group / percentage of samples without bactericidal serum activity at 1:4 dilution in the ACWY group) x100 percentage."|VE|81.8|||||TWO_SIDED|97.5|80.4|83.1||||||To demonstrate the effectiveness of the rMenB+OMV NZ vaccine against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains as measured by bactericidal activity using enc-hSBA at 1 month after the 2-dose (0,6-M) schedule in MenB\_0\_6 group when compared to 1 month after the MenACWY dose in the ACWY group.||83.1|80.4|
70870513|NCT04502693|141226417|OTHER|Effectiveness of rMenB+OMV NZ vaccine is demonstrated if the LL of the 2-sided 97.5% CI for VE against the selected strain panel between the MenB\_0\_2\_6 and the ACWY groups is above 65%. VE is defined as 1- RR = (1- percentage of samples without bactericidal serum activity at 1:4 dilution in MenB group / percentage of samples without bactericidal serum activity at 1:4 dilution in the ACWY group) x100 percentage.|VE|78.7|||||TWO_SIDED|97.5|77.2|80.1||||||To demonstrate the effectiveness of the rMenB+OMV NZ vaccine against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains as measured by bactericidal activity using enc-hSBA at 1 month after the 2-dose (0,2-M) schedule in MenB\_0\_2\_6 group when compared to 1 month after the MenACWY dose in the ACWY group.||80.1|77.2|
70870514|NCT04502693|141226420|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y are within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.96|||||TWO_SIDED|95.0|0.84|1.1||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-2 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup A at 1 month after last vaccination (Day 211).||1.10|0.84|
70870515|NCT04502693|141226420|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.86|||||TWO_SIDED|95.0|0.75|0.98||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup A at 1 month after last vaccination (Day 211).||0.98|0.75|
70870516|NCT04502693|141226420|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.9|||||TWO_SIDED|95.0|0.78|1.02||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-2 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup A at 1 month after last vaccination (Day 211).||1.02|0.78|
70870517|NCT04502693|141226420|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y are within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.92|||||TWO_SIDED|95.0|0.76|1.11||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-2 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup C at 1 month after last vaccination (Day 211).||1.11|0.76|
70870518|NCT04502693|141226420|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|1.17|||||TWO_SIDED|95.0|0.97|1.41||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup C at 1 month after last vaccination (Day 211).||1.41|0.97|
70870519|NCT04502693|141226420|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|1.27|||||TWO_SIDED|95.0|1.05|1.54||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-2 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup C at 1 month after last vaccination (Day 211).||1.54|1.05|
70870520|NCT04502693|141226420|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y are within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.89|||||TWO_SIDED|95.0|0.77|1.02||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-2 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup W at 1 month after last vaccination (Day 211).||1.02|0.77|
70870521|NCT04502693|141226420|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.88|||||TWO_SIDED|95.0|0.77|1.02||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup W at 1 month after last vaccination (Day 211).||1.02|0.77|
70952809|NCT03635099|141407208|OTHER|First the response rate of PASI 75 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline PASI score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0008||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Emax1 model fit.|Model assumption: 30% of the maximum effect is achieved at 50 mg.||||||0.0008
70952810|NCT03635099|141407208|OTHER|First the response rate of PASI 75 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline PASI score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0217||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Emax2 model fit.|Model assumption: 80% of the maximum effect is achieved at 50 mg.||||||0.0217
70952811|NCT03635099|141407208|OTHER|First the response rate of PASI 75 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline PASI score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0004||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Exponential model fit.|Model assumption: 5% of the maximum effect is achieved at 25 mg.||||||0.0004
70952812|NCT03635099|141407209|OTHER||Risk Difference (RD)|2.5||||0.4758|TWO_SIDED|95.0|-2.3|7.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.3|-2.3|0.4758
70952813|NCT03635099|141407209|OTHER||Risk Difference (RD)|7.7||||0.203|TWO_SIDED|95.0|-0.7|16.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||16.1|-0.7|0.2030
70952814|NCT03635099|141407209|OTHER||Risk Difference (RD)|5.1||||0.3028|TWO_SIDED|95.0|-1.8|12.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||12.1|-1.8|0.3028
70952815|NCT03635099|141407209|OTHER||Risk Difference (RD)|27.5||||0.0095|TWO_SIDED|95.0|13.7|41.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||41.3|13.7|0.0095
70952816|NCT03635099|141407209|OTHER|First the response rate of sPGA 0/1 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline sPGA score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0007||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Linear model fit.|||||||0.0007
70952817|NCT03635099|141407209|OTHER|First the response rate of sPGA 0/1 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline sPGA score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0023||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Logistic model fit.|Model assumption: 10% of the maximum effect is achieved at 25 mg and 80% of the maximum effect is achieved at 100 mg.||||||0.0023
70952818|NCT03635099|141407209|OTHER|First the response rate of sPGA 0/1 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline sPGA score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0018||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Emax1 model fit.|Model assumption: 30% of the maximum effect is achieved at 50 mg.||||||0.0018
70952819|NCT03635099|141407209|OTHER|First the response rate of sPGA 0/1 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline sPGA score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0386||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Emax2 model fit.|Model assumption: 80% of the maximum effect is achieved at 50 mg.||||||0.0386
70952820|NCT03635099|141407209|OTHER|First the response rate of sPGA 0/1 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline sPGA score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0004||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Exponential model fit.|Model assumption: 5% of the maximum effect is achieved at 25 mg.||||||0.0004
70952821|NCT03635099|141407210|OTHER||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-11.7|11.7|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||11.7|-11.7|1.0000
70952822|NCT03635099|141407210|OTHER||Risk Difference (RD)|20.6||||0.054|TWO_SIDED|95.0|3.9|37.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||37.3|3.9|0.0540
70952823|NCT03635099|141407210|OTHER||Risk Difference (RD)|15.5||||0.1167|TWO_SIDED|95.0|-0.4|31.4|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||31.4|-0.4|0.1167
70952824|NCT03635099|141407210|OTHER||Risk Difference (RD)|45.0||||0.0006|TWO_SIDED|95.0|26.8|63.2|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||63.2|26.8|0.0006
70870522|NCT04502693|141226420|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.99|||||TWO_SIDED|95.0|0.86|1.14||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-2 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup W at 1 month after last vaccination (Day 211).||1.14|0.86|
70870523|NCT04502693|141226420|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y are within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.86|||||TWO_SIDED|95.0|0.73|1.01||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-2 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup Y at 1 month after last vaccination (Day 211).||1.01|0.73|
70870524|NCT04502693|141226420|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.83|||||TWO_SIDED|95.0|0.71|0.98||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup Y at 1 month after last vaccination (Day 211).||0.98|0.71|
70870525|NCT04502693|141226420|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.97|||||TWO_SIDED|95.0|0.82|1.14||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-2 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup Y at 1 month after last vaccination (Day 211).||1.14|0.82|
70870526|NCT04502693|141226421|NON_INFERIORITY|Non-inferiority of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for the difference in percentage of participants with 4-fold rise between the 2 groups is above -10%.|Difference in percentage of participants|11.29|||||TWO_SIDED|95.0|5.88|19.01|||Difference in percentage of participants|||To demonstrate the immunological non-inferiority of the MenABCWY vaccine compared to the MenACWY vaccine in participants without a previous MenACWY vaccination (unprimed) as measured by the percentages of participants, achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup A at 1 month after the last MenABCWY vaccination (Day 211) and 1 month after the MenACWY vaccination.||19.01|5.88|
70872255|NCT03782792|141229723|OTHER|||||||0.0012||||||One-sided P Value.|Wilcoxon (Mann-Whitney)|||The effect of spesolimab was evaluated by a Wilcoxon rank test using the RS. Any assessments after death, the use of escape medication (before or after Day 8), open label spesolimab on Day 8, or rescue medication with spesolimab after Day 8 were assigned worst ranks for the testing. Missing data at Week 4 were imputed and handled via assessment of ranks.|The difference between treatments, based on the RS, using a modified Hodges-Lehmann (HL) estimate of the median difference and 95% Confidence Intervals could not be calculated due to lack of valid data.|||0.0012
70872256|NCT03782792|141229724|OTHER||Risk Difference (RD)|0.375|||||TWO_SIDED|95.0|0.058|0.581|||||Risk difference=Response rate of spesolimab - response rate of placebo.|Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.581|0.058|
70952825|NCT03635099|141407210|OTHER||Risk Difference (RD)|45.8|||||TWO_SIDED|95.0|22.0|69.6|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||69.6|22.0|
70952826|NCT03635099|141407210|OTHER||Risk Difference (RD)|35.2|||||TWO_SIDED|95.0|11.3|59.2|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||59.2|11.3|
70952827|NCT03635099|141407211|OTHER||Risk Difference (RD)|5.1||||0.3028|TWO_SIDED|95.0|-1.8|12.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||12.1|-1.8|0.3028
70952828|NCT03635099|141407211|OTHER||Risk Difference (RD)|2.6||||0.4701|TWO_SIDED|95.0|-2.4|7.5|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.5|-2.4|0.4701
70952829|NCT03635099|141407211|OTHER||Risk Difference (RD)|17.5||||0.0465|TWO_SIDED|95.0|5.7|29.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||29.3|5.7|0.0465
70952830|NCT03635099|141407211|OTHER||Risk Difference (RD)|9.3|||||TWO_SIDED|95.0|0.6|18.0|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||18.0|0.6|
70952831|NCT03635099|141407211|OTHER||Risk Difference (RD)|4.8|||||TWO_SIDED|95.0|-1.7|11.2|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||11.2|-1.7|
70952832|NCT03635099|141407212|OTHER||Risk Difference (RD)|2.6||||0.4701|TWO_SIDED|95.0|-2.4|7.5|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.5|-2.4|0.4701
70952833|NCT03635099|141407212|OTHER||Risk Difference (RD)|5.0||||0.3091|TWO_SIDED|95.0|-1.8|11.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||11.8|-1.8|0.3091
70952834|NCT03635099|141407212|OTHER||Risk Difference (RD)|2.3|||||TWO_SIDED|95.0|-2.2|6.8|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||6.8|-2.2|
70952835|NCT03635099|141407212|OTHER||Risk Difference (RD)|2.4|||||TWO_SIDED|95.0|-2.2|7.0|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||7.0|-2.2|
71144950|NCT05546476|141783340|SUPERIORITY||Difference in LS Mean|8.11|||=|0.1529|TWO_SIDED|90.0|-5.01|21.23|||MMRM analysis; 1-sided|||Moderate to Vigorous Physical Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||21.23|-5.01|=0.1529
71144951|NCT05546476|141783341|SUPERIORITY||Difference in LS Mean|-130.27|||=|0.5762|TWO_SIDED|90.0|-1257.31|996.77|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||996.77|-1257.31|=0.5762
70952836|NCT03635099|141407213|OTHER||Risk Difference (RD)|2.5||||0.4758|TWO_SIDED|95.0|-2.3|7.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.3|-2.3|0.4758
70952837|NCT03635099|141407213|OTHER||Risk Difference (RD)|2.6||||0.4701|TWO_SIDED|95.0|-2.4|7.5|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.5|-2.4|0.4701
70952838|NCT03635099|141407213|OTHER||Risk Difference (RD)|12.8||||0.0942|TWO_SIDED|95.0|2.3|23.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||23.3|2.3|0.0942
70952839|NCT03635099|141407213|OTHER||Risk Difference (RD)|27.5||||0.0095|TWO_SIDED|95.0|13.7|41.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||41.3|13.7|0.0095
70952840|NCT03635099|141407213|OTHER||Risk Difference (RD)|5.0||||0.3091|TWO_SIDED|95.0|-1.8|11.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||11.8|-1.8|0.3091
70952841|NCT03635099|141407213|OTHER||Risk Difference (RD)|7.7||||0.203|TWO_SIDED|95.0|-0.7|16.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||16.1|-0.7|0.2030
71144952|NCT05546476|141783341|SUPERIORITY||Difference in LS Mean|724.14|||=|0.1486|TWO_SIDED|90.0|-425.81|1874.09|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1874.09|-425.81|=0.1486
70870527|NCT04502693|141226421|NON_INFERIORITY|Non-inferiority of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for the difference in percentage of participants with 4-fold rise between the 2 groups is above -10%.|Difference in percentage of participants|47.22|||||TWO_SIDED|95.0|38.14|56.3||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine compared to the MenACWY vaccine in participants without a previous MenACWY vaccination (unprimed) as measured by the percentages of participants, achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup C at 1 month after the last MenABCWY vaccination (Day 211) and 1 month after the MenACWY vaccination.||56.30|38.14|
71144953|NCT05546476|141783341|SUPERIORITY||Difference in LS Mean|185.62|||=|0.3972|TWO_SIDED|90.0|-997.94|1369.18|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1369.18|-997.94|=0.3972
71144954|NCT05546476|141783342|SUPERIORITY||Difference in LS Mean|1587.26|||=|0.0985|TWO_SIDED|90.0|-443.79|3618.31|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||3618.31|-443.79|=0.0985
71144955|NCT05546476|141783342|SUPERIORITY||Difference in LS Mean|-98.54|||=|0.5315|TWO_SIDED|90.0|-2169.67|1972.58|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1972.58|-2169.67|=0.5315
71144956|NCT05546476|141783342|SUPERIORITY||Difference in LS Mean|2203.18|||=|0.0437|TWO_SIDED|90.0|84.51|4321.85|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||4321.85|84.51|=0.0437
71144957|NCT05546476|141783343|SUPERIORITY||Difference in LS Mean|0.0|||=|0.5052|TWO_SIDED|90.0|-0.046|0.045|||MMRM analysis; 1-sided|||Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.045|-0.046|=0.5052
71144958|NCT05546476|141783343|SUPERIORITY||Difference in LS Mean|-0.004|||=|0.5599|TWO_SIDED|90.0|-0.05|0.042|||MMRM analysis; 1-sided|||Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.042|-0.050|=0.5599
71144959|NCT05546476|141783343|SUPERIORITY||Difference in LS Mean|0.017|||=|0.277|TWO_SIDED|90.0|-0.03|0.064|||MMRM analysis; 1-sided|||Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.064|-0.030|=0.2770
71144960|NCT05546476|141783343|SUPERIORITY||Difference in LS Mean|0.0|||=|0.5047|TWO_SIDED|90.0|-0.071|0.07|||MMRM analysis; 1-sided|||95th Percentile of Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.070|-0.071|=0.5047
71144961|NCT05546476|141783343|SUPERIORITY||Difference in LS Mean|-0.026|||=|0.7316|TWO_SIDED|90.0|-0.097|0.045|||MMRM analysis; 1-sided|||95th Percentile of Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.045|-0.097|=0.7316
70952842|NCT03635099|141407213|OTHER||Risk Difference (RD)|10.3||||0.138|TWO_SIDED|95.0|0.7|19.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||19.8|0.7|0.1380
70952843|NCT03635099|141407213|OTHER||Risk Difference (RD)|32.5||||0.004|TWO_SIDED|95.0|18.0|47.0|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||47.0|18.0|0.0040
70952844|NCT03635099|141407213|OTHER||Risk Difference (RD)|10.3||||0.138|TWO_SIDED|95.0|0.7|19.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||19.8|0.7|0.1380
70952845|NCT03635099|141407213|OTHER||Risk Difference (RD)|35.0||||0.0025|TWO_SIDED|95.0|20.2|49.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||49.8|20.2|0.0025
70952846|NCT03635099|141407214|OTHER||Risk Difference (RD)|2.6||||0.4701|TWO_SIDED|95.0|-2.4|7.5|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.5|-2.4|0.4701
70952847|NCT03635099|141407214|OTHER||Risk Difference (RD)|5.0||||0.3091|TWO_SIDED|95.0|-1.8|11.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||11.8|-1.8|0.3091
70952848|NCT03635099|141407215|OTHER||Risk Difference (RD)|2.5||||0.4758|TWO_SIDED|95.0|-2.3|7.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.3|-2.3|0.4758
70952849|NCT03635099|141407215|OTHER||Risk Difference (RD)|5.1||||0.3028|TWO_SIDED|95.0|-1.8|12.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||12.1|-1.8|0.3028
70952850|NCT03635099|141407215|OTHER||Risk Difference (RD)|7.7||||0.203|TWO_SIDED|95.0|-0.7|16.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||16.1|-0.7|0.2030
70952851|NCT03635099|141407215|OTHER||Risk Difference (RD)|30.0||||0.0062|TWO_SIDED|95.0|15.8|44.2|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||44.2|15.8|0.0062
70952852|NCT03635099|141407215|OTHER||Risk Difference (RD)|10.3||||0.138|TWO_SIDED|95.0|0.7|19.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||19.8|0.7|0.1380
70952853|NCT03635099|141407215|OTHER||Risk Difference (RD)|5.1||||0.3028|TWO_SIDED|95.0|-1.8|12.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||12.1|-1.8|0.3028
71144962|NCT05546476|141783343|SUPERIORITY||Difference in LS Mean|0.01|||=|0.4145|TWO_SIDED|90.0|-0.063|0.082|||MMRM analysis; 1-sided|||95th Percentile of Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.082|-0.063|=0.4145
70952854|NCT03635099|141407215|OTHER||Risk Difference (RD)|25.0||||0.0143|TWO_SIDED|95.0|11.6|38.4|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||38.4|11.6|0.0143
70952855|NCT03635099|141407215|OTHER||Risk Difference (RD)|7.7||||0.203|TWO_SIDED|95.0|-0.7|16.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||16.1|-0.7|0.2030
70952856|NCT03635099|141407215|OTHER||Risk Difference (RD)|10.3||||0.138|TWO_SIDED|95.0|0.7|19.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||19.8|0.7|0.1380
70952857|NCT03635099|141407215|OTHER||Risk Difference (RD)|32.5||||0.004|TWO_SIDED|95.0|18.0|47.0|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||47.0|18.0|0.0040
70952858|NCT03635099|141407216|OTHER||Adjusted mean|0.5|STANDARD_ERROR_OF_MEAN|1.2||0.7008|TWO_SIDED|95.0|-1.9|2.8|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.|||2.8|-1.9|0.7008
70952859|NCT03635099|141407216|OTHER||Adjusted mean|0.6|STANDARD_ERROR_OF_MEAN|1.2||0.6268|TWO_SIDED|95.0|-1.8|3.0|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.|||3.0|-1.8|0.6268
70952860|NCT03635099|141407216|OTHER||Adjusted mean|2.7|STANDARD_ERROR_OF_MEAN|1.2||0.0266|TWO_SIDED|95.0|0.3|5.1|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.|||5.1|0.3|0.0266
70952861|NCT03635099|141407216|OTHER||Adjusted mean|4.0|STANDARD_ERROR_OF_MEAN|1.2||0.0009|TWO_SIDED|95.0|1.7|6.3|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.|||6.3|1.7|0.0009
70952862|NCT03635099|141407216|OTHER||Adjusted mean|3.1|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|0.4|5.8|||||MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.|||5.8|0.4|
70952863|NCT03635099|141407216|OTHER||Adjusted mean|3.1|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|0.4|5.8|||||MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.|||5.8|0.4|
70952864|NCT03635099|141407217|OTHER||Risk Difference (RD)|2.5||||0.7144|TWO_SIDED|95.0|-10.1|15.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||15.1|-10.1|0.7144
70870528|NCT04502693|141226421|NON_INFERIORITY|Non-inferiority of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for the difference in percentage of participants with 4-fold rise between the 2 groups is above -10%.|Difference in percentage of participants|35.31|||||TWO_SIDED|95.0|26.88|44.49||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine compared to the MenACWY vaccine in participants without a previous MenACWY vaccination (unprimed) as measured by the percentages of participants, achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup W at 1 month after the last MenABCWY vaccination (Day 211) and 1 month after the MenACWY vaccination.||44.49|26.88|
70870529|NCT04502693|141226421|NON_INFERIORITY|Non-inferiority of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for the difference in percentage of participants with 4-fold rise between the 2 groups is above -10%.|Difference in percentage of participants|26.99|||||TWO_SIDED|95.0|19.38|35.81||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine compared to the MenACWY vaccine in participants without a previous MenACWY vaccination (unprimed) as measured by the percentages of participants, achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup Y at 1 month after the last MenABCWY vaccination (Day 211) and 1 month after the MenACWY vaccination.||35.81|19.38|
70870530|NCT04502693|141226422|OTHER|Effectiveness of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for VE against the selected strain panel between the ABCWY and the ACWY groups is above 65%. VE is defined as 1- RR = (1- percentage of samples without bactericidal serum activity at 1:4 dilution in ABCWY\_Pooled group / percentage of samples without bactericidal serum activity at 1:4 dilution in the ACWY group) x100 percentage.|VE|77.9|||||TWO_SIDED|95.0|76.6|79.2||||||To demonstrate the effectiveness of the MenABCWY vaccine against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains as measured by enc-hSBA at 1 month after the last MenABCWY vaccination (Day 211) when compared to 1 month after the MenACWY vaccination.||79.2|76.6|
70870531|NCT04502693|141226423|NON_INFERIORITY|Non-inferiority of MenABCWY to rMenB+OMV NZ is demonstrated if LL of the 2-sided 95% CI for the difference in percentages of samples with bactericidal serum activity at 1:4 dilution is above -5%.|Difference in percentage of participants|-0.61|||||TWO_SIDED|95.0|-1.25|0.03||||||To demonstrate the non-inferiority of the effectiveness of the MenABCWY vaccine (0,6-months schedule) compared to the rMenB+OMV NZ vaccine (0,2-months) in terms of percentage of samples with bactericidal serum activity using enc-hSBA against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains.||0.03|-1.25|
70870532|NCT01552694|141226453|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||A priori threshold for statistical significance was p\<0.05. Unadjusted p-value compares the change (week 8 - baseline) for plasma hsCRP between the 2 groups.|t-test, 2 sided|||||||0.006
70870533|NCT01552694|141226454|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED|||||A priori threshold for statistical significance was p\<0.05. Unadjusted analysis.|t-test, 2 sided|||||||0.24
70870534|NCT01552694|141226455|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED|||||A priori threshold for statistical significance was p\<0.05. Unadjusted analysis|t-test, 2 sided|||||||0.78
70870535|NCT00418457|141226478|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.84|TWO_SIDED|95.0|0.74|1.28|||Regression, Cox|||||1.28|0.74|0.84
70870536|NCT00418457|141226479|SUPERIORITY||Odds Ratio (OR)|1.0||||0.7|TWO_SIDED|95.0|0.85|1.17|||GEE|||||1.17|0.85|0.70
70870537|NCT00418457|141226480|SUPERIORITY||Odds Ratio (OR)|0.98||||0.81|TWO_SIDED|95.0|0.75|1.28|||GEE|||||1.28|0.75|0.81
70870538|NCT00418457|141226481|SUPERIORITY||Mean Difference (Final Values)|-0.014||||0.96|TWO_SIDED|95.0|-0.63|0.6|||Mixed Models Analysis|||||0.60|-0.63|0.96
70952865|NCT03635099|141407217|OTHER||Risk Difference (RD)|2.7||||0.697|TWO_SIDED|95.0|-10.0|15.4|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||15.4|-10.0|0.6970
70870539|NCT00418457|141226482|SUPERIORITY||Mean Difference (Final Values)|0.75||||0.043|TWO_SIDED|95.0|0.02|1.48|||Mixed Models Analysis|||||1.48|0.02|0.043
70870540|NCT02610725|141226526|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_DEVIATION|0.81||0.013|TWO_SIDED|95.0|-3.73|-0.46|||t-test, 2 sided|51 degrees of freedom.|Means were analyzed in (pre-post) format. A negative mean here indicates an increase in positive affect.|Paired-samples t-tests were used to analyze change in affect after participating in the yoga class. Analyses were conducted to measure changes in both positive affect and negative affect. This entry describes positive affect analysis.||-0.46|-3.73|0.013
70952866|NCT03635099|141407217|OTHER||Risk Difference (RD)|2.7||||0.697|TWO_SIDED|95.0|-10.0|15.4|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||15.4|-10.0|0.6970
70870541|NCT02610725|141226526|SUPERIORITY||Mean Difference (Final Values)|6.06|STANDARD_ERROR_OF_MEAN|0.98|<|0.001|TWO_SIDED|95.0|4.1|8.02|||t-test, 2 sided|51 degrees of freedom|Means were analyzed in a (pre-post) format. A positive mean indicates a decrease in negative affect.|Paired-samples t-tests were used to analyze change in affect after participating in the yoga class. Analyses were conducted to measure changes in both positive affect and negative affect. This entry describes negative affect analysis.||8.02|4.10|<0.001
70870542|NCT00826943|141226533|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||The threshold for significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||.03
70870543|NCT00826943|141226533|SUPERIORITY_OR_OTHER|||||||0.11||||||The threshold for significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||.11
70870544|NCT00826943|141226533|SUPERIORITY_OR_OTHER|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||||||.45
70952867|NCT03635099|141407217|OTHER||Risk Difference (RD)|15.0||||0.125|TWO_SIDED|95.0|-0.6|30.6|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||30.6|-0.6|0.1250
70952868|NCT03635099|141407217|OTHER||Risk Difference (RD)|7.9|||||TWO_SIDED|95.0|-20.3|36.1|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||36.1|-20.3|
70870545|NCT00826943|141226534|SUPERIORITY_OR_OTHER|||||||0.27||95.0||||The threshold for significance was p \< .05.|Wilcoxon (Mann-Whitney)|||||||.27
70870546|NCT00826943|141226534|SUPERIORITY_OR_OTHER|||||||0.8||||||The threshold for significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||.8
70870547|NCT00826943|141226534|SUPERIORITY_OR_OTHER|||||||0.52||||||The threshold for significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||.52
70870548|NCT00826943|141226535|SUPERIORITY_OR_OTHER|||||||0.14||95.0||||The threshold for significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||.14
70870549|NCT00826943|141226535|SUPERIORITY_OR_OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||.54
70870550|NCT00826943|141226535|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||.42
70870551|NCT01703039|141226562|SUPERIORITY|||||||0.06|||||||ANOVA|||||||0.06
70870552|NCT01703039|141226563|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||0.31
70870553|NCT01703039|141226564|SUPERIORITY|||||||0.34|||||||Chi-squared|||||||0.34
70870554|NCT01703039|141226565|SUPERIORITY|||||||0.27|||||||ANOVA|||||||0.27
70870555|NCT01703039|141226566|SUPERIORITY|||||||0.04|||||||ANOVA|||||||0.04
70870556|NCT00147446|141226575|SUPERIORITY_OR_OTHER||Wilcoxon two smaple test statistics|2.09||||0.04||95.0|||||Wilcoxon (Mann-Whitney)|||It was hypothesized that treatment with stress management produced a significant reduction in cumulative Gd+ lesions compared to the control condition during the treatment period||||0.04
70952869|NCT03635099|141407217|OTHER||Risk Difference (RD)|6.2|||||TWO_SIDED|95.0|-21.9|34.3|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||34.3|-21.9|
70952870|NCT01840410|141407258|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.94|STANDARD_ERROR_OF_MEAN|1.502|<|0.001|TWO_SIDED|95.0|6.97|12.91|||Mixed Models Analysis|||||12.91|6.97|<0.001
70870557|NCT00147446|141226575|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.77||||0.02|TWO_SIDED|95.0|1.17|6.55|||Logistic Regression|||It was hypothesized that significantly greater numbers of participants receiving stress management remained free of Gd+ lesions during the treatment, compared to those receiving the control condition.||6.55|1.17|0.02
70870558|NCT00147446|141226576|SUPERIORITY_OR_OTHER||Wilcoxon two sample test statistics|2.84||||0.005||95.0|||||Wilcoxon (Mann-Whitney)|||It was hypothesized that participants receiving SMT-MS showed a significant reduction in cumulative new T2 lesions, compared to those receiving the control condition during the treatment period.||||0.005
70870559|NCT00147446|141226576|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.07||||0.006|TWO_SIDED|95.0|1.38|6.81|||Logistic Regression|||It was hypothesized that significantly greater numbers of participants receiving SMT-MS remained free of new T2 lesions during the treatment, compared to control condition participants.||6.81|1.38|0.006
70870560|NCT02302807|141226587|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.4134|TWO_SIDED|95.0|0.63|1.21|||Log Rank|||||1.21|0.63|0.4134
70870561|NCT02302807|141226587|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.71|1.05||||||||1.05|0.71|
70870562|NCT02302807|141226587|SUPERIORITY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.73|0.99||||||||0.99|0.73|
70952871|NCT02671500|141407290|SUPERIORITY||||||<|0.001|||||||2-sided 1 sample exact binomial test|||A sample size of 260 participants in Region 1 would provide more than 80% power to detect an improvement of at least 6 percentage points in SVR12 rate from the performance goal of 85% by using a two-sided exact one-sample binomial test at the significance level of 0.05.||||<0.001
70870563|NCT03329573|141226598|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% confidence interval of AUC(0-infinity) for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|1.059|||||TWO_SIDED|90.0|1.006|1.115||||||||1.115|1.006|
70870564|NCT03329573|141226599|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% confidence interval of AUC(0-infinity) for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|0.996|||||TWO_SIDED|90.0|0.947|1.047||||||||1.047|0.947|
70870565|NCT03329573|141226600|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% confidence interval of AUC(0-t) for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|1.064|||||TWO_SIDED|90.0|1.01|1.12||||||||1.120|1.010|
70870566|NCT03329573|141226601|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% confidence interval of AUC(0-t) for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|0.996|||||TWO_SIDED|90.0|0.949|1.044||||||||1.044|0.949|
70870567|NCT03329573|141226602|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% confidence interval of Cmax for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|1.024|||||TWO_SIDED|90.0|0.952|1.101||||||||1.101|0.952|
70870568|NCT03329573|141226603|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% confidence interval of Cmax for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|1.02|||||TWO_SIDED|90.0|0.968|1.074||||||||1.074|0.968|
70870569|NCT00650260|141226628|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||Fisher Exact|||||||0.027
70870570|NCT00650260|141226629|SUPERIORITY_OR_OTHER|||||||0.078||95.0|||||t-test, 1 sided|||||||0.078
70870571|NCT00650260|141226632|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
70870572|NCT03307967|141226636|OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Signed Rank Sum||||||.07
70870573|NCT03307967|141226637|OTHER|||||||0.98|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Signed Rank Sum Test||||||.98
70870574|NCT02166905|141226653|OTHER||Hazard Ratio (HR)|0.4||||0.177|TWO_SIDED|90.0|0.1|1.2|||Log Rank||Reference=arm 1|||1.2|0.1|0.177
70870575|NCT02617628|141226659|EQUIVALENCE|The odds ratio for relapse versus non-relapse for the AR group relative to the BR group was analyzed, as well as the corresponding odds ratio for unknown relative to non-relapse.|Odds Ratio (OR)|1.56||||0.38|TWO_SIDED|95.0|0.57|4.27|||Regression, Logistic||Threshold for significance was set at p\<.05|Based on Lee et al. we estimated a 23-33% group difference in relapse by month 3. Power estimates calculated this estimate with a 2-sided alpha of .05 and a baseline sample size of 100 per group resulted in 80% power to detect a difference of approximately 20% (OR = 2.4) between groups assuming a rate of 50% in the control condition and 10% and 20% attrition by 3- and 6-month follow-ups. For the 86 participants randomized and released, with 80% power; and odds ratio of 3.5.||4.27|0.57|0.38
70870576|NCT02617628|141226660|SUPERIORITY||Cox Proportional Hazard|-0.74486||||0.01|TWO_SIDED|95.0|||||Regression, Cox|||We used Cox proportional hazards regression model to compare the groups on time to reincarceration.||||0.01
70870577|NCT02065375|141226661|SUPERIORITY||Difference in proportion of patients|-1.2||||0.4543|TWO_SIDED|95.0|-21.3|18.9|||Chi-squared|p values from Pearson chi-squared statistical test between the Omaveloxolone Ophthalmic suspension 1.0% and placebo were one sided.||||18.9|-21.3|0.4543
70870578|NCT02065375|141226661|SUPERIORITY||Difference in proportion of patients|8.2||||0.2297|TWO_SIDED|95.0|-13.5|29.8|||Chi-squared|p values from Pearson chi-squared statistical test between the Omaveloxolone Ophthalmic suspension 0.5% and placebo were one sided.||||29.8|-13.5|0.2297
70870579|NCT02065375|141226662|SUPERIORITY||Difference in proportion of patients|-21.6||||0.028|TWO_SIDED|95.0|-43.1|0.0|||Chi-squared|p values from Pearson chi-squared statistical test between the Omaveloxolone Ophthalmic suspension 1.0% and placebo were one sided.||||0.00|-43.1|.0280
70870580|NCT02065375|141226662|SUPERIORITY||Difference in proportion of patients|-24.0||||0.0192|TWO_SIDED|95.0|-45.8|-2.2|||Chi-squared|p values from Pearson chi-squared statistical test between the Omaveloxolone Ophthalmic suspension 0.5% and placebo were one sided.||||-2.2|-45.8|0.0192
70870581|NCT04518306|141226679|SUPERIORITY||LS Means Difference|-7.33|STANDARD_ERROR_OF_MEAN|1.451|<|0.0001|TWO_SIDED|95.0|-10.176|-4.486||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MIANALYZE procedure|||The analysis was performed using a mixed model for repeated measures (MMRM) for estimating the difference between Triple ¼ GMRx2 and placebo at Week 4||-4.486|-10.176|<0.0001
70870582|NCT04518306|141226679|SUPERIORITY||LS Means Difference|-8.23|STANDARD_ERROR_OF_MEAN|1.57|<|0.0001|TWO_SIDED|95.0|-11.305|-5.151||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MIANALYZE procedure|||The analysis was performed using a mixed model for repeated measures (MMRM) for estimating the difference between Triple ½ GMRx2 and placebo at Week 4||-5.151|-11.305|<0.0001
70870583|NCT04518306|141226680|SUPERIORITY||LS Means Difference|-7.98|STANDARD_ERROR_OF_MEAN|1.649|<|0.0001|TWO_SIDED|95.0|-11.281|-4.681||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||||-4.681|-11.281|<0.0001
70870584|NCT04518306|141226680|SUPERIORITY||LS Means Difference|-9.52|STANDARD_ERROR_OF_MEAN|2.034|<|0.0001|TWO_SIDED|95.0|-13.588|5.449||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||||5.449|-13.588|<0.0001
70870585|NCT04518306|141226681|SUPERIORITY||LS Means Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.204||0.0015|TWO_SIDED|95.0|-6.413|-1.597||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||||-1.597|-6.413|0.0015
70870586|NCT04518306|141226681|SUPERIORITY||LS Means Difference|-4.86|STANDARD_ERROR_OF_MEAN|1.133|<|0.0001|TWO_SIDED|95.0|-7.13|-2.595||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||||-2.595|-7.130|<0.0001
70870587|NCT04518306|141226682|SUPERIORITY||Risk Difference (RD)|28.09||||0.0002|TWO_SIDED|95.0|11.811|42.45|||Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method|||42.450|11.811|0.0002
70870588|NCT04518306|141226682|SUPERIORITY||Risk Difference (RD)|33.24|||<|0.0001|TWO_SIDED|95.0|17.199|47.186|||Wald test||95% confidence intervals for risk difference utilize Newcombe estimation method|||47.186|17.199|<0.0001
70870589|NCT04518306|141226683|SUPERIORITY||Risk Difference (RD)|17.18|||<|0.0001|TWO_SIDED|95.0|6.07|26.385||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo.|Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method.|Percentages were calculated from the total number of participants within the randomized set.||26.385|6.070|<0.0001
70870590|NCT04518306|141226683|SUPERIORITY||Risk Difference (RD)|27.08|||<|0.0001|TWO_SIDED|95.0|15.237|36.646||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method|Percentages were calculated from the total number of participants within the randomized set||36.646|15.237|<0.0001
70870591|NCT04518306|141226684|SUPERIORITY||LS Means Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.991||0.0002|TWO_SIDED|95.0|-5.978|-2.013||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||||-2.013|-5.978|0.0002
70870592|NCT04518306|141226684|SUPERIORITY||LS Means Difference|-5.51|STANDARD_ERROR_OF_MEAN|0.908|<|0.0001|TWO_SIDED|95.0|-7.328|-3.694||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||||-3.694|-7.328|<0.0001
70870593|NCT04518306|141226685|SUPERIORITY||LS Means Difference|-6.79|STANDARD_ERROR_OF_MEAN|1.752||0.0003|TWO_SIDED|95.0|-10.3|-3.287||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||The difference between Triple ¼ GMRx2 Dose and placebo at Week 4 was estimated using MMRM||-3.287|-10.300|0.0003
70870594|NCT04518306|141226685|SUPERIORITY||LS Means Difference|-8.74|STANDARD_ERROR_OF_MEAN|1.829|<|0.0001|TWO_SIDED|95.0|-12.403|-5.082||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||The difference between Triple ½ GMRx2 Dose and placebo at Week 4 was estimated using MMRM||-5.082|-12.403|<0.0001
70870595|NCT04518306|141226686|SUPERIORITY||LS Means Difference|-3.86|STANDARD_ERROR_OF_MEAN|1.004||0.0003|TWO_SIDED|95.0|-5.865|-1.847||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||The difference between Triple ¼ GMRx2 Dose and placebo at Week 4 was estimated using MMRM||-1.847|-5.865|0.0003
70870596|NCT04518306|141226686|SUPERIORITY||LS Means Difference|-5.42|STANDARD_ERROR_OF_MEAN|1.245|<|0.0001|TWO_SIDED|95.0|-7.915|-2.932||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||The difference between Triple ½ GMRx2 Dose and placebo at Week 4 was estimated using MMRM||-2.932|-7.915|<0.0001
70870597|NCT04518306|141226687|SUPERIORITY||Risk Difference (RD)|35.48|||<|0.0001|TWO_SIDED|95.0|19.541|48.549||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method|||48.549|19.541|<0.0001
70870598|NCT04518306|141226687|SUPERIORITY||Risk Difference (RD)|29.97|||<|0.0001|TWO_SIDED|95.0|14.218|43.093||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method|||43.093|14.218|<0.0001
70870599|NCT04518306|141226688|SUPERIORITY||Risk Difference (RD)|17.21||||0.003|TWO_SIDED|95.0|3.637|28.424||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method|||28.424|3.637|0.0030
70870600|NCT04518306|141226688|SUPERIORITY||Risk Difference (RD)|22.5|||<|0.0001|TWO_SIDED|95.0|8.72|33.665||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method|||33.665|8.720|<0.0001
70870601|NCT04518306|141226689|SUPERIORITY||Risk Difference (RD)|-1.61|||||TWO_SIDED|95.0|-9.83|2.76|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||2.760|-9.830|
70870602|NCT04518306|141226689|SUPERIORITY||Risk Difference (RD)|3.47|||||TWO_SIDED|95.0|-5.276|9.774|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||9.774|-5.276|
70870603|NCT04518306|141226690|SUPERIORITY||Risk Difference (RD)|-3.23|||||TWO_SIDED|95.0|-12.171|1.662|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||1.662|-12.171|
70870604|NCT04518306|141226690|SUPERIORITY||Risk Difference (RD)|-1.53|||||TWO_SIDED|95.0|-10.585|4.049||||||||4.049|-10.585|
70870605|NCT04518306|141226691|SUPERIORITY||Risk Difference (RD)|3.54|||||TWO_SIDED|95.0|-4.115|9.352|||||95% confidence intervals for risk difference utilize Newcombe estimation method|||9.352|-4.115|
70870606|NCT04518306|141226691|SUPERIORITY||Risk Difference (RD)|5.08|||||TWO_SIDED|95.0|-2.779|11.2||||||||11.200|-2.779|
70870607|NCT04518306|141226692|SUPERIORITY||Risk Difference (RD)|3.54|||||TWO_SIDED|95.0|-4.012|9.35|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||9.350|-4.012|
70952872|NCT00798434|141407333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|-2.12|-0.97|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline urgency episodes.||Based on a 2-sided t-test (5% significance). Null hypothesis: no difference in mean change in mean micturition-related urgency episodes per 24 hours at Week 12 for the 2 groups. Last observation carried forward (LOCF) method used for statistical analyses of the FAS (change from baseline to Week 12).||-0.97|-2.12|<0.0001
70952873|NCT00798434|141407334|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-14.44|||<|0.0001|TWO_SIDED|95.0|-14.67|-14.25|||2-sided Van Elteren's test||Hodges-Lehman estimate of median treatment difference and confidence interval (CI)|Week 12 LOCF||-14.25|-14.67|<0.0001
70952874|NCT00798434|141407335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.22||0.0001|TWO_SIDED|95.0|-1.28|-0.42|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline severe urgency episodes||Week 12 LOCF||-0.42|-1.28|0.0001
70870608|NCT04518306|141226692|SUPERIORITY||Risk Difference (RD)|0.84|||||TWO_SIDED|95.0|-6.364|5.278|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||5.278|-6.364|
70870609|NCT04518306|141226693|SUPERIORITY||Risk Difference (RD)|-1.22|||||TWO_SIDED|95.0|-10.928|5.573|||||95% confidence intervals for risk difference utilize Newcombe estimation method|||5.573|-10.928|
70952875|NCT00798434|141407336|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0005|TWO_SIDED|95.0|0.0|0.0|||2-sided Van Elteren's test||Hodges-Lehman estimate of median treatment difference and CI|Week 12 LOCF||0.00|0.00|0.0005
70870610|NCT04518306|141226693|SUPERIORITY||Risk Difference (RD)|4.27|||||TWO_SIDED|95.0|1.38|9.53|||||95% confidence intervals for risk difference utilize Newcombe estimation method|||9.53|1.38|
70870611|NCT04518306|141226694|SUPERIORITY||Risk Difference (RD)|1.95|||||TWO_SIDED|95.0|-6.492|7.954|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||7.954|-6.492|
70870612|NCT04518306|141226694|SUPERIORITY||Risk Difference (RD)|3.45|||||TWO_SIDED|95.0|-5.171|9.704|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||9.704|-5.171|
70870613|NCT04518306|141226695|SUPERIORITY||Risk Difference (RD)|0.88|||||TWO_SIDED|95.0|-6.324|5.548|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||5.548|-6.324|
70952876|NCT00798434|141407337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.33|-0.64|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline number of micturitions||Week 12 LOCF||-0.64|-1.33|<0.0001
70952877|NCT00798434|141407338|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-7.31|||<|0.0001|TWO_SIDED|95.0|-7.4|-7.19|||2-sided Van Elteren's test|||Week 12 LOCF||-7.19|-7.40|<0.0001
70870614|NCT04518306|141226695|SUPERIORITY||number of participants at 95% CI|0.0|||||TWO_SIDED|95.0|0.0|3.05|||||For this particular parameter we have used number of participants at 95% CI computed from Clopper-Pearson method as no risk difference was found between the Triple ½ (GMRx2) vs placebo|||3.05|0.00|
70870615|NCT04518306|141226696|SUPERIORITY||Risk Difference (RD)|-1.59|||||TWO_SIDED|95.0|-9.684|2.778|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||2.778|-9.684|
70870616|NCT04518306|141226696|SUPERIORITY||Risk Difference (RD)|-1.59|||||TWO_SIDED|95.0|-9.684|2.59|||||95% confidence intervals for risk difference utilized Newcombe estimation method.|||2.590|-9.684|
70870617|NCT04518306|141226697|SUPERIORITY||Risk Difference (RD)|4.27|||||TWO_SIDED|95.0|-6.722|12.959|||||95% confidence intervals for risk difference utilized Newcombe estimation method.|||12.959|-6.722|
70870618|NCT04518306|141226697|SUPERIORITY||Risk Difference (RD)|3.73|||||TWO_SIDED|95.0|-7.158|12.133|||||95% confidence intervals for risk difference utilized Newcombe estimation method.|||12.133|-7.158|
70870619|NCT04518306|141226698|SUPERIORITY||Risk Difference (RD)|1.43|||||TWO_SIDED|95.0|-8.585|8.916||||||||8.916|-8.585|
70870620|NCT04518306|141226698|SUPERIORITY||Risk Difference (RD)|-1.4|||||TWO_SIDED|95.0|-11.077|5.161||||||||5.161|-11.077|
70870621|NCT04518306|141226699|SUPERIORITY||Risk Difference (RD)|-3.82|||<|0.0001|TWO_SIDED|95.0|-17.664|8.366|||GEE procedure|||||8.366|-17.664|<0.0001
70870622|NCT04518306|141226699|SUPERIORITY||LS Means|5.42|||<|0.0001|TWO_SIDED|95.0|-9.04|17.981|||GEE procedure|||||17.981|-9.040|<0.0001
70870623|NCT02801331|141226730|EQUIVALENCE|A test of equivalence was conducted for unadjusted comparisons. A chi squared test of proportions was used for unadjusted comparisons.||||||0.6||||||Unadjusted|Chi-squared|||||||.60
70870624|NCT02801331|141226731|EQUIVALENCE|A statistical test comparing cumulative morphine dose was performed for the cohort that was treated with morphine (n=60)||||||0.62|||||||t-test, 2 sided|degrees of freedom =58 for cohort analyzed that received morphine treatment.||||||.62
70870625|NCT02801331|141226732|EQUIVALENCE|A statistical test comparing day of life discharged among untreated infants who completed hospitalization at study site (n=181).||||||0.29|||||||t-test, 2 sided|df = 179 based on number of infants who completed hospitalization at study site.||||||0.29
70870626|NCT02801331|141226733|EQUIVALENCE|A statistical test comparing day of life discharged among untreated infants (n=121)||||||0.55|||||||t-test, 2 sided|df = 119 based on number of infants who did not receive morphine treatment.||||||0.55
70870627|NCT02801331|141226734|EQUIVALENCE|A statistical test comparing day of life discharged among treated infants, n=60||||||0.36|||||||t-test, 2 sided|df = 58 based on number of infants who received morphine treatment.||||||0.36
70870628|NCT02801331|141226735|EQUIVALENCE|A test of equivalence was conducted for unadjusted comparisons. A t test of means was used for unadjusted comparisons.||||||0.56|||||||t-test, 2 sided|df = 58 based on number of infants who received morphine treatment.||||||0.56
70870629|NCT02801331|141226736|EQUIVALENCE|A statistical test comparing day of life infant started treatment as performed for the cohort that was treated with morphine (n=60)||||||0.25|||||||t-test, 2 sided|df = 58 based on number of infants who received morphine treatment.||||||0.25
70870630|NCT05438888|141226754|OTHER||Hazard Ratio (HR)|0.753|||<|0.001|TWO_SIDED|95.0|0.711|0.798|||Log Rank|||||0.798|0.711|<0.001
70870631|NCT05438888|141226755|OTHER||Hazard Ratio (HR)|0.687|||<|0.001|TWO_SIDED|95.0|0.622|0.76|||Log Rank|||||0.760|0.622|<0.001
70870632|NCT05438888|141226756|OTHER||Hazard Ratio (HR)|0.638|||<|0.001|TWO_SIDED|95.0|0.57|0.714|||Log Rank|||||0.714|0.570|<0.001
70870633|NCT05438888|141226757|OTHER||Hazard Ratio (HR)|0.854|||<|0.001|TWO_SIDED|95.0|0.791|0.922|||Log Rank|||||0.922|0.791|<0.001
70952878|NCT00798434|141407339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.08||0.0026|TWO_SIDED|95.0|-0.4|-0.09|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline number of night-time micturitions||Week 12 LOCF||-0.09|-0.40|0.0026
70870634|NCT05438888|141226758|OTHER||Hazard Ratio (HR)|0.638|||<|0.001|TWO_SIDED|95.0|0.57|0.715|||Log Rank|||||0.715|0.570|<0.001
70870635|NCT05438888|141226759|OTHER||Hazard Ratio (HR)|0.868|||<|0.001|TWO_SIDED|95.0|0.807|0.934|||Log Rank|||||0.934|0.807|<0.001
70870636|NCT05438888|141226760|OTHER||Hazard Ratio (HR)|0.646|||<|0.001|TWO_SIDED|95.0|0.503|0.83|||Log Rank|||||0.830|0.503|<0.001
70870637|NCT02761252|141226761|SUPERIORITY||Mean Difference (Final Values)|-0.194|STANDARD_ERROR_OF_MEAN|0.3429||0.5721|TWO_SIDED|95.0|-0.8693|0.4813|||ANCOVA|||||0.4813|-0.8693|0.5721
70870638|NCT02761252|141226762|SUPERIORITY||Mean Difference (Final Values)|-1.1552|STANDARD_ERROR_OF_MEAN|0.4489||0.0105|TWO_SIDED|95.0|-2.0379|-0.2725|||ANCOVA|||||-0.2725|-2.0379|0.0105
70870639|NCT02761252|141226763|SUPERIORITY||Mean Difference (Final Values)|-0.1393|STANDARD_ERROR_OF_MEAN|0.2009||0.4885|TWO_SIDED|95.0|-0.5342|0.2557|||ANCOVA|||||0.2557|-0.5342|0.4885
70870640|NCT02761252|141226764|SUPERIORITY||Mean Difference (Final Values)|-0.03615|STANDARD_ERROR_OF_MEAN|0.1504||0.81032|TWO_SIDED|95.0|-0.3319|0.2596|||ANCOVA|||||0.2596|-0.3319|0.81032
71144963|NCT05546476|141783344|SUPERIORITY||Difference in LS Mean|4.24|||=|0.0114|TWO_SIDED|90.0|1.19|7.28|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||7.28|1.19|=0.0114
71144964|NCT05546476|141783344|SUPERIORITY||Difference in LS Mean|0.64|||=|0.36|TWO_SIDED|90.0|-2.3|3.57|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||3.57|-2.30|=0.3600
70870641|NCT02761252|141226765|OTHER||Mean Difference (Final Values)|0.8359|STANDARD_ERROR_OF_MEAN|0.9322||0.3704|TWO_SIDED|95.0|-0.9969|2.6688|||ANOVA|||||2.6688|-0.9969|0.3704
71144965|NCT05546476|141783344|SUPERIORITY||Difference in LS Mean|4.11|||=|0.0138|TWO_SIDED|90.0|1.06|7.17|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||7.17|1.06|=0.0138
71144966|NCT05546476|141783345|SUPERIORITY||Difference in LS Mean|2.35|||=|0.009|TWO_SIDED|90.0|0.72|3.97|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||3.97|0.72|=0.0090
71144967|NCT05546476|141783345|SUPERIORITY||Difference in LS Mean|0.0|||=|0.4987|TWO_SIDED|90.0|-1.55|1.56|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.56|-1.55|=0.4987
71144968|NCT05546476|141783345|SUPERIORITY||Difference in LS Mean|2.3|||=|0.01|TWO_SIDED|90.0|0.68|3.92|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||3.92|0.68|=0.0100
71144969|NCT05546476|141783346|SUPERIORITY||Difference in LS Mean|0.43|||=|0.1912|TWO_SIDED|90.0|-0.38|1.24|||MMRM analysis; 1-sided|||Appetite: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.24|-0.38|=0.1912
71144970|NCT05546476|141783346|SUPERIORITY||Difference in LS Mean|0.46|||=|0.1866|TWO_SIDED|90.0|-0.39|1.3|||MMRM analysis; 1-sided|||Appetite: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.30|-0.39|=0.1866
71144971|NCT05546476|141783346|SUPERIORITY||Difference in LS Mean|0.92|||=|0.0349|TWO_SIDED|90.0|0.09|1.75|||MMRM analysis; 1-sided|||Appetite: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.75|0.09|=0.0349
71144972|NCT05546476|141783346|SUPERIORITY||Difference in LS Mean|0.47|||=|0.8754|TWO_SIDED|90.0|-0.2|1.14|||MMRM analysis; 1-sided|||Nausea: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.14|-0.20|=0.8754
71144973|NCT05546476|141783346|SUPERIORITY||Difference in LS Mean|0.38|||=|0.8205|TWO_SIDED|90.0|-0.31|1.08|||MMRM analysis; 1-sided|||Nausea: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.08|-0.31|=0.8205
71144974|NCT05546476|141783346|SUPERIORITY||Difference in LS Mean|-0.17|||=|0.3375|TWO_SIDED|90.0|-0.86|0.51|||MMRM analysis; 1-sided|||Nausea: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.51|-0.86|=0.3375
71144975|NCT05546476|141783346|SUPERIORITY||Difference in LS Mean|0.66|||=|0.9138|TWO_SIDED|90.0|-0.14|1.45|||MMRM analysis; 1-sided|||Physical Fatigue: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.45|-0.14|=0.9138
71144976|NCT05546476|141783346|SUPERIORITY||Difference in LS Mean|0.64|||=|0.9011|TWO_SIDED|90.0|-0.18|1.46|||MMRM analysis; 1-sided|||Physical Fatigue: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.46|-0.18|=0.9011
70870642|NCT02761252|141226766|SUPERIORITY||Median Difference (Final Values)|-0.837|STANDARD_ERROR_OF_MEAN|2.5735||0.7452|TWO_SIDED|95.0|-5.8968|4.2228|||ANOVA|||||4.2228|-5.8968|0.7452
70870643|NCT00381485|141226826|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
70870644|NCT00381485|141226826|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
70870645|NCT01206660|141226830|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70870646|NCT01206660|141226831|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70870647|NCT01206660|141226832|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70870648|NCT04249583|141226899|SUPERIORITY|||||||0.05|||||||Cochran-Mantel-Haenszel|||||||0.05
70870649|NCT03000439|141226901|OTHER||Hazard Ratio (HR)|0.633|||=|0.1171|TWO_SIDED|95.0|0.296|1.354||1-sided p-value is provided.|Unstratified log-rank test||Hazard ratio and 95% CI was based on Cox proportional hazards model with treatment group as covariate. Hazard ratio \< 1 indicates a reduction in hazard ratio in favor of Tofacitinib 5 mg BID to Placebo.|||1.354|0.296|= 0.1171
70870650|NCT03000439|141226902|OTHER||Difference in percentage|0.7|||||TWO_SIDED|95.0|-12.2|13.6|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 4||13.6|-12.2|
70870651|NCT03000439|141226902|OTHER||Difference in percentage|-8.3|||||TWO_SIDED|95.0|-27.9|11.3|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 8||11.3|-27.9|
70870652|NCT03000439|141226902|OTHER||Difference in percentage|-10.8|||||TWO_SIDED|95.0|-33.2|11.6|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 12||11.6|-33.2|
70870653|NCT03000439|141226902|OTHER||Difference in percentage|-13.7|||||TWO_SIDED|95.0|-37.2|9.8|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 16||9.8|-37.2|
70870654|NCT03000439|141226902|OTHER||Difference in percentage|-13.2|||||TWO_SIDED|95.0|-37.9|11.5|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 20||11.5|-37.9|
70952879|NCT00798434|141407340|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-9.52||||0.0012|TWO_SIDED|95.0|-9.52|-9.09|||2-sided Van Elteren's test|||Week 12 LOCF||-9.09|-9.52|0.0012
70870655|NCT03000439|141226902|OTHER||Difference in percentage|-13.2|||||TWO_SIDED|95.0|-37.9|11.5|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 24||11.5|-37.9|
70870656|NCT03000439|141226902|OTHER||Difference in percentage|-9.4|||||TWO_SIDED|95.0|-34.5|15.6|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 28||15.6|-34.5|
70870657|NCT03000439|141226902|OTHER||Difference in percentage|-14.0|||||TWO_SIDED|95.0|-39.5|11.5|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 32||11.5|-39.5|
70870658|NCT03000439|141226902|OTHER||Difference in percentage|-9.4|||||TWO_SIDED|95.0|-35.5|16.7|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 36||16.7|-35.5|
70870659|NCT03000439|141226902|OTHER||Difference in percentage|-9.4|||||TWO_SIDED|95.0|-35.5|16.7|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 40||16.7|-35.5|
70870660|NCT03000439|141226902|OTHER||Difference in percentage|-15.0|||||TWO_SIDED|95.0|-41.8|11.8|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 44||11.8|-41.8|
70870661|NCT03000439|141226902|OTHER||Difference in percentage|-15.0|||||TWO_SIDED|95.0|-41.8|11.8|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 48||11.8|-41.8|
70952880|NCT00798434|141407341|SUPERIORITY_OR_OTHER||Hodges-Lehman estimate|0.0||||0.1005|TWO_SIDED|95.0|0.0|0.0||The protocol-defined analysis (ANOVA, parametric) not presented because normality assumptions were not met, instead an alternative analysis (Van-Elteren'ts test, non-parametric) as defined in the statistical analysis plan presented.|Van-Elteren's Test||Hodges-Lehman estimate of median treatment difference and CI|Week 12 LOCF||0.00|0.00|0.1005
70870662|NCT03000439|141226902|OTHER||Difference in percentage|-15.0|||||TWO_SIDED|95.0|-41.8|11.8|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 52||11.8|-41.8|
70870663|NCT03000439|141226905|OTHER||Difference in percentage|-11.41|||||TWO_SIDED|95.0|-28.02|5.21|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 4||5.21|-28.02|
70870664|NCT03000439|141226905|OTHER||Difference in percentage|1.5|||||TWO_SIDED|95.0|-18.37|21.36|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 8||21.36|-18.37|
70870665|NCT03000439|141226905|OTHER||Difference in percentage|0.46|||||TWO_SIDED|95.0|-22.68|23.6|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 12||23.60|-22.68|
70870666|NCT03000439|141226905|OTHER||Difference in percentage|10.14|||||TWO_SIDED|95.0|-13.82|34.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 16||34.10|-13.82|
70870667|NCT03000439|141226905|OTHER||Difference in percentage|16.24|||||TWO_SIDED|95.0|-8.43|40.92|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 20||40.92|-8.43|
70870668|NCT03000439|141226905|OTHER||Difference in percentage|9.45|||||TWO_SIDED|95.0|-15.49|34.39|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 24||34.39|-15.49|
70870669|NCT03000439|141226905|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 28||34.33|-16.13|
70870670|NCT03000439|141226905|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 32||34.33|-16.13|
70870671|NCT03000439|141226905|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 36||34.33|-16.13|
70870672|NCT03000439|141226905|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 40||34.33|-16.13|
70870673|NCT03000439|141226905|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 44||34.33|-16.13|
70870674|NCT03000439|141226905|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 48||37.56|-12.91|
70870675|NCT03000439|141226905|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 52||37.56|-12.91|
70870676|NCT03000439|141226905|OTHER||Difference in percentage|-11.41|||||TWO_SIDED|95.0|-28.02|5.21|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 4||5.21|-28.02|
70870677|NCT03000439|141226905|OTHER||Difference in percentage|4.72|||||TWO_SIDED|95.0|-15.72|25.17|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 8||25.17|-15.72|
70870678|NCT03000439|141226905|OTHER||Difference in percentage|0.46|||||TWO_SIDED|95.0|-22.68|23.6|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 12||23.60|-22.68|
70870679|NCT03000439|141226905|OTHER||Difference in percentage|13.36|||||TWO_SIDED|95.0|-10.76|37.48|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 16||37.48|-10.76|
70870680|NCT03000439|141226905|OTHER||Difference in percentage|19.47|||||TWO_SIDED|95.0|-5.2|44.14|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 20||44.14|-5.20|
70870681|NCT03000439|141226905|OTHER||Difference in percentage|9.45|||||TWO_SIDED|95.0|-15.49|34.39|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 24||34.39|-15.49|
70870682|NCT03000439|141226905|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 28||34.33|-16.13|
70870683|NCT03000439|141226905|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 32||34.33|-16.13|
70870684|NCT03000439|141226905|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 36||34.33|-16.13|
70870685|NCT03000439|141226905|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 40||34.33|-16.13|
70870686|NCT03000439|141226905|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 44||37.56|-12.91|
70870687|NCT03000439|141226905|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 48||37.56|-12.91|
70870688|NCT03000439|141226905|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 52||37.56|-12.91|
70870689|NCT03000439|141226905|OTHER||Difference in percentage|-13.82|||||TWO_SIDED|95.0|-38.14|10.49|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 4||10.49|-38.14|
70870690|NCT03000439|141226905|OTHER||Difference in percentage|-9.56|||||TWO_SIDED|95.0|-32.28|13.15|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 8||13.15|-32.28|
70870691|NCT03000439|141226905|OTHER||Difference in percentage|-0.23|||||TWO_SIDED|95.0|-24.7|24.24|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 12||24.24|-24.70|
70870692|NCT03000439|141226905|OTHER||Difference in percentage|5.88|||||TWO_SIDED|95.0|-19.31|31.06|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 16||31.06|-19.31|
70870693|NCT03000439|141226905|OTHER||Difference in percentage|19.12|||||TWO_SIDED|95.0|-5.81|44.06|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 20||44.06|-5.81|
70870694|NCT03000439|141226905|OTHER||Difference in percentage|1.96|||||TWO_SIDED|95.0|-23.55|27.47|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 24||27.47|-23.55|
70870695|NCT03000439|141226905|OTHER|The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|Difference in percentage|15.21|||||TWO_SIDED|95.0|-10.05|40.46|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 28||40.46|-10.05|
70870696|NCT03000439|141226905|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 32||37.56|-12.91|
70870697|NCT03000439|141226905|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 36||34.33|-16.13|
70870698|NCT03000439|141226905|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 40||37.56|-12.91|
70870699|NCT03000439|141226905|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 44||37.56|-12.91|
70952881|NCT00798434|141407342|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0218|TWO_SIDED|95.0|0.0|0.0|||2-sided Van Elteren's test|||Week 12 LOCF||0.00|0.00|0.0218
70952882|NCT00798434|141407343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-6.3|-3.1|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and daily sum rating of USS at baseline||Week 12 LOCF||-3.10|-6.30|<0.0001
70952883|NCT00798434|141407344|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.515||||0.1113|TWO_SIDED|95.0|0.909|2.528||Logistic regression determined the odds of improvement versus no improvement in dryness, where improvement was defined as dry at both weeks 8 and 12 relative to baseline incontinence.|Regression, Logistic|Covariates were treatment, study center, dosing time, and age category||LOCF||2.528|0.909|0.1113
70952884|NCT00798434|141407345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.11||0.023|TWO_SIDED|95.0|-0.47|-0.04|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline number of pads per 24 hours||Incontinence pads at Week 12 LOCF||-0.04|-0.47|0.0230
70952885|NCT00798434|141407345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.03||0.0909|TWO_SIDED|95.0|-0.12|0.01|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline number of creams per 24 hours||Creams at Week 12 LOCF||0.01|-0.12|0.0909
70952886|NCT00798434|141407345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.2039|TWO_SIDED|95.0|-0.08|0.02|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline number of powders per 24 hours||Powder at Week 12 LOCF||0.02|-0.08|0.2039
70952887|NCT00798434|141407346|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.096|||<|0.0001|TWO_SIDED|95.0|2.181|4.395|||Regression, Logistic|Covariates were treatment, study center, dosing time, and age category||Week 12 LOCF||4.395|2.181|<0.0001
70952888|NCT00798434|141407349|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.506|||<|0.0001|TWO_SIDED|95.0|1.767|3.556||Logistic regression determined the odds of improvement versus no improvement in PPBC score, where improvement was defined as a negative change from baseline.|Regression, Logistic|Covariates were treatment, study center, dosing time, age category, and baseline PPBC category||Week 12 LOCF||3.556|1.767|<0.0001
70952889|NCT00798434|141407353|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.916||||0.0009|TWO_SIDED|95.0|1.305|2.811||Logistic regression determined the odds of improvement versus no improvement in PPBC score, where improvement was defined as an increase of 1 or more points in difference of scores relative to baseline.|Regression, Logistic|Covariates were treatment, study center, dosing time, age category, and baseline PPUS category||LOCF||2.811|1.305|0.0009
70952890|NCT00798434|141407355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.12|STANDARD_ERROR_OF_MEAN|1.29|<|0.0001|TWO_SIDED|95.0|-9.65|-4.59|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline symptom/bother score||Week 12 LOCF||-4.59|-9.65|<0.0001
70952891|NCT00798434|141407356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.48|STANDARD_ERROR_OF_MEAN|1.14|<|0.0001|TWO_SIDED|95.0|2.24|6.73|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total health-related quality of life (HRQL) score.||Week 12 LOCF||6.73|2.24|<0.0001
70952892|NCT00798434|141407357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.39|STANDARD_ERROR_OF_MEAN|1.44||0.0002|TWO_SIDED|95.0|2.57|8.22|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline HRQL subscale score||Coping Subscale at Week 12; LOCF||8.22|2.57|0.0002
71144977|NCT05546476|141783346|SUPERIORITY||Difference in LS Mean|0.21|||=|0.6618|TWO_SIDED|90.0|-0.61|1.02|||MMRM analysis; 1-sided|||Physical Fatigue: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.02|-0.61|=0.6618
70952893|NCT00798434|141407357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.39|STANDARD_ERROR_OF_MEAN|1.29|<|0.0001|TWO_SIDED|95.0|2.84|7.93|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline HRQL subscale score||Concern Subscale at Week 12; LOCF||7.93|2.84|<0.0001
70870700|NCT03000439|141226905|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 48||37.56|-12.91|
70952894|NCT00798434|141407357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.09|STANDARD_ERROR_OF_MEAN|1.38||0.0032|TWO_SIDED|95.0|1.38|6.81|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline HRQL subscale score||Sleep Subscale at Week 12; LOCF||6.81|1.38|0.0032
70952895|NCT00798434|141407357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.51|STANDARD_ERROR_OF_MEAN|1.03||0.0152|TWO_SIDED|95.0|0.49|4.53|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline HRQL subscale score||Social Subscale at Week 12; LOCF||4.53|0.49|0.0152
71144978|NCT00807911|141783354|OTHER||Hazard Ratio (HR)|0.657||||0.047|TWO_SIDED|95.0|0.434|0.994|||t-test, 1 sided|||||0.994|0.434|0.047
71144979|NCT00807911|141783355|OTHER||Hazard Ratio (HR)|0.602||||0.04|TWO_SIDED|95.0|0.371|0.977|||t-test, 1 sided|||||0.977|0.371|0.040
71144980|NCT00807911|141783356|OTHER||Hazard Ratio (HR)|0.744||||0.47|TWO_SIDED|95.0|0.334|1.657|||t-test, 1 sided|||||1.657|0.334|0.47
71144981|NCT00807911|141783357|OTHER||Hazard Ratio (HR)|0.456||||0.036|TWO_SIDED|95.0|0.215|0.97|||t-test, 1 sided|||||0.970|0.215|0.036
71144982|NCT02135861|141783369|OTHER||Mean Difference (Final Values)|0.16||||0.0029|TWO_SIDED|95.0|0.06|0.26||estimates of total lung|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2600|0.0600|0.0029
71144983|NCT02135861|141783369|OTHER||Mean Difference (Final Values)|0.1825||||0.0007|TWO_SIDED|95.0|0.0855|0.2795||estimates of left lung|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2795|0.0855|0.0007
71144984|NCT02135861|141783369|OTHER||Mean Difference (Final Values)|0.1565||||0.0093|TWO_SIDED|95.0|0.0419|0.2711||estimates of right lung|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2711|0.0419|0.0093
71144985|NCT02135861|141783369|OTHER||Mean Difference (Final Values)|0.1764||||0.0007|TWO_SIDED|95.0|0.0823|0.2704||estimates of left lung apical|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2704|0.0823|0.0007
70870701|NCT03000439|141226905|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 52||37.56|-12.91|
71144986|NCT02135861|141783369|OTHER||Mean Difference (Final Values)|0.1999||||0.001|TWO_SIDED|95.0|0.0894|0.3103||estimates of left lung basal|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.3103|0.0894|0.0010
71144987|NCT02135861|141783369|OTHER||Mean Difference (Final Values)|0.136||||0.0159|TWO_SIDED|95.0|0.0276|0.2443||estimates of right lung apical|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2443|0.0276|0.0159
71144988|NCT02135861|141783369|OTHER||Mean Difference (Final Values)|0.1748||||0.0064|TWO_SIDED|95.0|0.0535|0.2961||estimates of right lung basal|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2961|0.0535|0.0064
71144989|NCT02135861|141783370|OTHER||Mean Difference (Final Values)|-0.0137||||0.7381|TWO_SIDED|95.0|-0.0968|0.0695||estimates of total lung|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0695|-0.0968|0.7381
71144990|NCT02135861|141783370|OTHER||Mean Difference (Final Values)|0.0136||||0.6992|TWO_SIDED|95.0|-0.058|0.0852||estimates of left lung|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0852|-0.0580|0.6992
71144991|NCT02135861|141783370|OTHER||Mean Difference (Final Values)|-0.0258||||0.5778|TWO_SIDED|95.0|-0.1201|0.0684||estimates of right lung|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0684|-0.1201|0.5778
71144992|NCT02135861|141783370|OTHER||Mean Difference (Final Values)|0.0005||||0.9899|TWO_SIDED|95.0|-0.0738|0.0747||estimates of left lung apical|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0747|-0.0738|0.9899
71144993|NCT02135861|141783370|OTHER||Mean Difference (Final Values)|0.0396||||0.2912|TWO_SIDED|95.0|-0.036|0.1153||estimates of left lung basal|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.1153|-0.0360|0.2912
71144994|NCT02135861|141783370|OTHER||Mean Difference (Final Values)|-0.0362||||0.4592|TWO_SIDED|95.0|-0.1355|0.0631||estimates of right lung apical|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0631|-0.1355|0.4592
71144995|NCT02135861|141783370|OTHER||Mean Difference (Final Values)|-0.0118||||0.7936|TWO_SIDED|95.0|-0.1036|0.08||estimates of right lung basal|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0800|-0.1036|0.7936
71144996|NCT02135861|141783371|OTHER||Mean Difference (Final Values)|0.1148||||0.0156|TWO_SIDED|95.0|0.0236|0.2061||estimates of total lung- Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2061|0.0236|0.0156
71144997|NCT02135861|141783371|OTHER||Mean Difference (Final Values)|0.1366||||0.0026|TWO_SIDED|95.0|0.0523|0.2209||estimates of left lung- Pre-exercise|ANOVA|estimates of left lung- Pre-exercise|||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2209|0.0523|0.0026
71144998|NCT02135861|141783371|OTHER||Mean Difference (Final Values)|0.1067||||0.0328|TWO_SIDED|95.0|0.0094|0.204||estimates of right lung- Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2040|0.0094|0.0328
71144999|NCT02135861|141783371|OTHER||Mean Difference (Final Values)|0.1145||||0.0158|TWO_SIDED|95.0|0.0235|0.2056||estimates of left lung apical-Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2056|0.0235|0.0158
71145000|NCT02135861|141783371|OTHER||Mean Difference (Final Values)|0.1776||||0.0002|TWO_SIDED|95.0|0.0917|0.2635||estimates of left lung basal-Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2635|0.0917|0.0002
71145001|NCT02135861|141783371|OTHER||Mean Difference (Final Values)|0.0956||||0.0658|TWO_SIDED|95.0|-0.0067|0.1979||estimates of right lung apical-Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.1979|-0.0067|0.0658
70870702|NCT03000439|141226905|OTHER||Difference in percentage|-19.82|||||TWO_SIDED|95.0|-44.09|4.46|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 4||4.46|-44.09|
70870703|NCT03000439|141226905|OTHER||Difference in percentage|-17.28|||||TWO_SIDED|95.0|-40.19|5.63|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 8||5.63|-40.19|
70870704|NCT03000439|141226905|OTHER||Difference in percentage|-7.6|||||TWO_SIDED|95.0|-29.66|14.45|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 20||14.45|-29.66|
70870705|NCT03000439|141226905|OTHER||Difference in percentage|-13.71|||||TWO_SIDED|95.0|-37.19|9.77|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 12||9.77|-37.19|
70870706|NCT03000439|141226905|OTHER||Difference in percentage|-4.03|||||TWO_SIDED|95.0|-26.67|18.61|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 16||18.61|-26.67|
70870707|NCT03000439|141226905|OTHER||Difference in percentage|-14.75|||||TWO_SIDED|95.0|-35.32|5.83|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 32||5.83|-35.32|
70870708|NCT03000439|141226905|OTHER||Difference in percentage|-4.38|||||TWO_SIDED|95.0|-26.02|17.26|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 24||17.26|-26.02|
70870709|NCT03000439|141226905|OTHER||Difference in percentage|-7.95|||||TWO_SIDED|95.0|-28.89|12.99|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 28||12.99|-28.89|
70870710|NCT03000439|141226905|OTHER||Difference in percentage|-6.91|||||TWO_SIDED|95.0|-30.65|16.83|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 36||16.83|-30.65|
70870711|NCT03000439|141226905|OTHER||Difference in percentage|-3.69|||||TWO_SIDED|95.0|-27.16|19.78|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 40||19.78|-27.16|
70870712|NCT03000439|141226905|OTHER||Difference in percentage|-0.46|||||TWO_SIDED|95.0|-23.6|22.68|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 44||22.68|-23.60|
70870713|NCT03000439|141226905|OTHER||Difference in percentage|-0.46|||||TWO_SIDED|95.0|-23.6|22.68|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 48||22.68|-23.60|
70870714|NCT03000439|141226905|OTHER||Difference in percentage|-0.46|||||TWO_SIDED|95.0|-23.6|22.68|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 52||22.68|-23.60|
70870715|NCT03000439|141226905|OTHER||Difference in percentage|-21.2|||||TWO_SIDED|95.0|-42.45|0.05|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 4||0.05|-42.45|
70870716|NCT03000439|141226905|OTHER||Difference in percentage|-18.32|||||TWO_SIDED|95.0|-37.98|1.34|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 8||1.34|-37.98|
70870717|NCT03000439|141226905|OTHER||Difference in percentage|-11.52|||||TWO_SIDED|95.0|-31.65|8.61|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 12||8.61|-31.65|
70870718|NCT03000439|141226905|OTHER||Difference in percentage|-7.95|||||TWO_SIDED|95.0|-28.89|12.99|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 16||12.99|-28.89|
70870719|NCT03000439|141226905|OTHER||Difference in percentage|1.38|||||TWO_SIDED|95.0|-16.15|18.91|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 20||18.91|-16.15|
70870720|NCT03000439|141226905|OTHER||Difference in percentage|-1.5|||||TWO_SIDED|95.0|-21.36|18.37|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 24||18.37|-21.36|
70870721|NCT03000439|141226905|OTHER||Difference in percentage|-8.29|||||TWO_SIDED|95.0|-27.91|11.32|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 28||11.32|-27.91|
70870722|NCT03000439|141226905|OTHER||Difference in percentage|-15.09|||||TWO_SIDED|95.0|-34.29|4.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 32||4.10|-34.29|
70870723|NCT03000439|141226905|OTHER||Difference in percentage|-11.52|||||TWO_SIDED|95.0|-31.65|8.61|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 36||8.61|-31.65|
70870724|NCT03000439|141226905|OTHER||Difference in percentage|-7.6|||||TWO_SIDED|95.0|-29.66|14.45|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 40||14.45|-29.66|
70870725|NCT03000439|141226905|OTHER||Difference in percentage|-4.38|||||TWO_SIDED|95.0|-26.02|17.26|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 44||17.26|-26.02|
70870726|NCT03000439|141226905|OTHER||Difference in percentage|-0.81|||||TWO_SIDED|95.0|-23.04|21.43|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 48||21.43|-23.04|
70870727|NCT03000439|141226905|OTHER||Difference in percentage|-0.81|||||TWO_SIDED|95.0|-23.04|21.43|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 52||21.43|-23.04|
70870728|NCT03000439|141226913|OTHER||Difference in percentage|-7.83|||||TWO_SIDED|95.0|-23.42|7.75|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 4||7.75|-23.42|
70870729|NCT03000439|141226913|OTHER||Difference in percentage|5.07|||||TWO_SIDED|95.0|-13.94|24.08|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 8||24.08|-13.94|
71145002|NCT02135861|141783371|OTHER||Mean Difference (Final Values)|0.1194||||0.015|TWO_SIDED|95.0|0.0251|0.2137||estimates of right lung basal-Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2137|0.0251|0.0150
70870730|NCT03000439|141226913|OTHER||Difference in percentage|0.81|||||TWO_SIDED|95.0|-21.43|23.04|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 12||23.04|-21.43|
70870731|NCT03000439|141226913|OTHER||Difference in percentage|10.14|||||TWO_SIDED|95.0|-13.82|34.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 16||34.10|-13.82|
71145003|NCT02135861|141783371|OTHER||Mean Difference (Final Values)|0.1428||||0.0015|TWO_SIDED|95.0|0.0598|0.2259||estimates of total lung-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2259|0.0598|0.0015
71145004|NCT02135861|141783371|OTHER||Mean Difference (Final Values)|0.1776|||<|0.0001|TWO_SIDED|95.0|0.1057|0.2496||estimates of left lung-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2496|0.1057|<.0001
71145005|NCT02135861|141783371|OTHER||Mean Difference (Final Values)|0.126||||0.0114|TWO_SIDED|95.0|0.0308|0.2212||estimates of right lung-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2212|0.0308|0.0114
71145006|NCT02135861|141783371|OTHER||Mean Difference (Final Values)|0.1464||||0.0002|TWO_SIDED|95.0|0.0774|0.2153||estimates of left lung apical-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2153|0.0774|0.0002
71145007|NCT02135861|141783371|OTHER||Mean Difference (Final Values)|0.2137|||<|0.0001|TWO_SIDED|95.0|0.1266|0.3008||estimates of left lung basal-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.3008|0.1266|<.0001
71145008|NCT02135861|141783371|OTHER||Mean Difference (Final Values)|0.1111||||0.025|TWO_SIDED|95.0|0.0151|0.2071||estimates of right lung apical-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2071|0.0151|0.0250
71145009|NCT02135861|141783371|OTHER||Mean Difference (Final Values)|0.1458||||0.0052||95.0|0.0475|0.2442||estimates of right lung basal-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2442|0.0475|0.0052
71145010|NCT02135861|141783372|OTHER||Mean Difference (Final Values)|-0.0524||||0.173|TWO_SIDED|95.0|-0.1292|0.0244||estimates of total lung-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0244|-0.1292|0.1730
71145011|NCT02135861|141783372|OTHER||Mean Difference (Final Values)|-0.0423||||0.2704|TWO_SIDED|95.0|-0.1196|0.0349||estimates of left lung-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0349|-0.1196|0.2704
71145012|NCT02135861|141783372|OTHER||Mean Difference (Final Values)|-0.0515||||0.2072|TWO_SIDED|95.0|-0.1334|0.0303||estimates of right lung-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0303|-0.1334|0.2072
71145013|NCT02135861|141783372|OTHER||Mean Difference (Final Values)|-0.0603||||0.1307|TWO_SIDED|95.0|-0.1398|0.0191||estimates of left lung apical-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0191|-0.1398|0.1307
71145014|NCT02135861|141783372|OTHER||Mean Difference (Final Values)|-0.0078||||0.8427|TWO_SIDED|95.0|-0.0879|0.0722||estimates of left lung basal-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0722|-0.0879|0.8427
71145015|NCT02135861|141783372|OTHER||Mean Difference (Final Values)|-0.0506||||0.1848|TWO_SIDED|95.0|-0.1269|0.0257||estimates of right lung apical-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0257|-0.1269|0.1848
71145016|NCT02135861|141783372|OTHER||Mean Difference (Final Values)|-0.0413||||0.3408|TWO_SIDED|95.0|-0.1286|0.0461||estimates of right lung basal-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0461|-0.1286|0.3408
71145017|NCT02135861|141783372|OTHER||Mean Difference (Final Values)|-0.0267||||0.3682|TWO_SIDED|95.0|-0.0866|0.0332||estimates of total lung-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0332|-0.0866|0.3682
70870732|NCT03000439|141226913|OTHER||Difference in percentage|16.24|||||TWO_SIDED|95.0|-8.43|40.92|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 20||40.92|-8.43|
70870733|NCT03000439|141226913|OTHER||Difference in percentage|9.45|||||TWO_SIDED|95.0|-15.49|34.39|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 24||34.39|-15.49|
70870734|NCT03000439|141226913|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 28||34.33|-16.13|
70870735|NCT03000439|141226913|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 32||34.33|-16.13|
70870736|NCT03000439|141226913|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 36||34.33|-16.13|
70870737|NCT03000439|141226913|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 40||34.33|-16.13|
70870738|NCT03000439|141226913|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 44||34.33|-16.13|
70870739|NCT03000439|141226913|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 48||37.56|-12.91|
70870740|NCT03000439|141226913|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 52||37.56|-12.91|
70870741|NCT03000439|141226919|OTHER||Difference in LS Mean|-0.01|||||TWO_SIDED|95.0|-2.4|2.38||||||DB Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.38|-2.40|
70870742|NCT03000439|141226919|OTHER||Difference in LS Mean|0.94|||||TWO_SIDED|95.0|-2.25|4.12||||||DB Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.12|-2.25|
70870743|NCT03000439|141226919|OTHER||Difference in LS Mean|-0.24|||||TWO_SIDED|95.0|-4.54|4.06||||||DB Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.06|-4.54|
70870744|NCT03000439|141226919|OTHER||Difference in LS Mean|-0.86|||||TWO_SIDED|95.0|-3.99|2.28||||||DB Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.28|-3.99|
70870745|NCT03000439|141226919|OTHER||Difference in LS Mean|-1.09|||||TWO_SIDED|95.0|-3.12|0.94||||||DB Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.94|-3.12|
70870746|NCT03000439|141226919|OTHER||Difference in LS Mean|0.3|||||TWO_SIDED|95.0|-1.46|2.06||||||DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.06|-1.46|
70870747|NCT03000439|141226919|OTHER||Difference in LS Mean|-1.28|||||TWO_SIDED|95.0|-7.85|5.29||||||DB Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||5.29|-7.85|
70870748|NCT03000439|141226919|OTHER||Difference in LS Mean|0.48|||||TWO_SIDED|95.0|-1.98|2.93||||||DB Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.93|-1.98|
70870749|NCT03000439|141226919|OTHER||Difference in LS Mean|-0.26|||||TWO_SIDED|95.0|-1.86|1.35||||||DB Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.35|-1.86|
70870750|NCT03000439|141226919|OTHER||Difference in LS Mean|0.73|||||TWO_SIDED|95.0|-2.18|3.63||||||DB Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||3.63|-2.18|
70870751|NCT03000439|141226919|OTHER||Difference in LS Mean|-0.83|||||TWO_SIDED|95.0|-3.22|1.56||||||DB Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.56|-3.22|
70870752|NCT03000439|141226919|OTHER||Difference in LS Mean|-0.23|||||TWO_SIDED|95.0|-1.76|1.3||||||DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.30|-1.76|
70870753|NCT03000439|141226919|OTHER||Difference in LS Mean|-0.75|||||TWO_SIDED|95.0|-3.43|1.93||||||DB Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.93|-3.43|
70870754|NCT03000439|141226920|OTHER||Difference in LS Mean|0.9|||||TWO_SIDED|95.0|-1.8|3.61||||||DB Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||3.61|-1.80|
70870755|NCT03000439|141226920|OTHER||Difference in LS Mean|2.11|||||TWO_SIDED|95.0|-0.64|4.86||||||DB Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.86|-0.64|
70870756|NCT03000439|141226920|OTHER||Difference in LS Mean|-0.02|||||TWO_SIDED|95.0|-4.25|4.21||||||DB Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.21|-4.25|
70952896|NCT00798434|141407358|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.537|||<|0.001|TWO_SIDED|95.0|2.281|5.484||Analysis determined the odds of responding on the OAB-S scale (satisfaction with OAB control) for Fesoterodine versus placebo, where a responder was defined as a response of 'satisfied' or better on all 7 questions at week 12.|Regression, Logistic|Covariates were treatment, study center, dosing time and age category||LOCF||5.484|2.281|<0.001
70952897|NCT00798434|141407359|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.881|||<|0.0001|TWO_SIDED|95.0|2.045|4.058||Analysis determined the odds of responding on the OAB-S scale (OAB medication expectation) for Fesoterodine versus placebo, where a responder was defined as a response of 'satisfied' or better on all 7 questions at week 12.|Regression, Logistic|Covariates were treatment, study center, dosing time and age category||LOCF||4.058|2.045|<0.0001
70952898|NCT00798434|141407360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.18|STANDARD_ERROR_OF_MEAN|4.12||0.3163|TWO_SIDED|95.0|-4.13|12.49|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||General Health Perception; LOCF||12.49|-4.13|0.3163
70952899|NCT00798434|141407360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.29|STANDARD_ERROR_OF_MEAN|8.63||0.4698|TWO_SIDED|95.0|-23.7|11.11|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Incontinence Impact; LOCF||11.11|-23.70|0.4698
70952900|NCT00798434|141407360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.85|STANDARD_ERROR_OF_MEAN|9.28||0.5321|TWO_SIDED|95.0|-24.58|12.88|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Role Limitations; LOCF||12.88|-24.58|0.5321
70952901|NCT00798434|141407360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.81|STANDARD_ERROR_OF_MEAN|8.39||0.6523|TWO_SIDED|95.0|-20.74|13.12|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Physical Limitations; LOCF||13.12|-20.74|0.6523
70952902|NCT00798434|141407360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.26|STANDARD_ERROR_OF_MEAN|6.8||0.6344|TWO_SIDED|95.0|-10.47|16.99|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Social Limitations; LOCF||16.99|-10.47|0.6344
70952903|NCT00798434|141407360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.11|STANDARD_ERROR_OF_MEAN|8.38||0.2013|TWO_SIDED|95.0|-28.71|6.49|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Personal Relationships; LOCF||6.49|-28.71|0.2013
71145018|NCT02135861|141783372|OTHER||Mean Difference (Net)|-0.0201||||0.4531|TWO_SIDED|95.0|-0.0744|0.0342||estimates of left lung-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0342|-0.0744|0.4531
71145019|NCT02135861|141783372|OTHER||Mean Difference (Final Values)|-0.0188||||0.597|TWO_SIDED|95.0|-0.0909|0.0533||estimates of right lung-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0533|-0.0909|0.5970
70952904|NCT00798434|141407360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.07|STANDARD_ERROR_OF_MEAN|6.88||0.3831|TWO_SIDED|95.0|-19.96|7.83|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Emotions; LOCF||7.83|-19.96|0.3831
70952905|NCT00798434|141407360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.46|STANDARD_ERROR_OF_MEAN|6.82||0.5167|TWO_SIDED|95.0|-9.3|18.23|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Sleep/Energy; LOCF||18.23|-9.30|0.5167
70952906|NCT00798434|141407360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.19|STANDARD_ERROR_OF_MEAN|5.12||0.0532|TWO_SIDED|95.0|-20.53|0.15|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Severity of Urinary Symptoms; LOCF||0.15|-20.53|0.0532
70952907|NCT00798434|141407361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0016|STANDARD_ERROR_OF_MEAN|0.0125||0.8959|TWO_SIDED|95.0|-0.0229|0.0262|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline single utility score||||0.0262|-0.0229|0.8959
71145020|NCT02135861|141783372|OTHER||Mean Difference (Final Values)|-0.0159||||0.5472|TWO_SIDED|95.0|-0.0693|0.0375||estimates of left lung apical-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0375|-0.0693|0.5472
70952908|NCT05292586|141407370|SUPERIORITY||Adjusted mean difference|0.104|||<|0.001|TWO_SIDED|95.0|0.061|0.148|||ANCOVA|||"1\_Change from baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.148|0.061|<0.001
71145021|NCT02135861|141783372|OTHER||Mean Difference (Final Values)|-0.0125||||0.6793|TWO_SIDED|95.0|-0.0742|0.0491||estimates of left lung basal-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0491|-0.0742|0.6793
70870757|NCT03000439|141226920|OTHER||Difference in LS Mean|-1.12|||||TWO_SIDED|95.0|-4.32|2.09||||||DB Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.09|-4.32|
70952909|NCT05292586|141407371|SUPERIORITY||Adjusted mean difference|0.124|||<|0.001|TWO_SIDED|95.0|0.076|0.173|||ANCOVA|||"1\_Change from baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.173|0.076|<0.001
70952910|NCT05292586|141407372|SUPERIORITY||Adjusted mean difference|0.101|||<|0.001|TWO_SIDED|95.0|0.063|0.139|||ANCOVA|||"1\_Change from baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.139|0.063|<0.001
70952911|NCT05292586|141407373|SUPERIORITY||Adjusted mean difference|0.113|||<|0.001|TWO_SIDED|95.0|0.071|0.154|||ANCOVA|||"1\_Change from baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.154|0.071|<0.001
71145022|NCT02135861|141783372|OTHER||Mean Difference (Final Values)|-0.0249||||0.4806|TWO_SIDED|95.0|-0.0964|0.0466||estimates of right lung apical-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0466|-0.0964|0.4806
71145023|NCT02135861|141783372|OTHER||Mean Difference (Final Values)|-0.0029||||0.9379|TWO_SIDED|95.0|-0.0789|0.0731||estimates of right lung basal-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0731|-0.0789|0.9379
71145024|NCT00333775|141783414|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0318|TWO_SIDED|95.0|0.63|0.98|||Log Rank|||||0.98|0.63|0.0318
71145025|NCT00333775|141783414|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.72||||0.0036|TWO_SIDED|95.0|0.57|0.9|||Log Rank|||||0.90|0.57|0.0036
70870758|NCT03000439|141226920|OTHER||Difference in LS Mean|-0.53|||||TWO_SIDED|95.0|-3.04|1.98||||||DB Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.98|-3.04|
70952912|NCT05292586|141407374|SUPERIORITY||Adjusted mean difference|0.069||||0.003|TWO_SIDED|95.0|0.023|0.115|||ANCOVA|||"1\_Change from baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.115|0.023|0.003
70952913|NCT05292586|141407375|SUPERIORITY||Adjusted mean difference|0.044||||0.05|TWO_SIDED|95.0|0.0|0.088|||ANCOVA|||"1\_Change from baseline -- Week 4~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.088|0.000|0.050
70952914|NCT05292586|141407375|SUPERIORITY||Adjusted mean difference|0.041||||0.098|TWO_SIDED|95.0|-0.007|0.089|||ANCOVA|||"2\_Change from baseline -- Week 8~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.089|-0.007|0.098
70952915|NCT05292586|141407375|SUPERIORITY||Adjusted mean difference|0.043||||0.056|TWO_SIDED|95.0|-0.001|0.086|||ANCOVA|||"3\_Change from baseline -- Week 12~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.086|-0.001|0.056
70952916|NCT05292586|141407376|SUPERIORITY||Odds Ratio (OR)|1.327||||0.098|TWO_SIDED|95.0|0.949|1.855|||Logistic regression model|||1\_Responders at Week 4||1.855|0.949|0.098
71145026|NCT00333775|141783417|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.1105|TWO_SIDED|95.0|0.69|1.04|||Log Rank|||||1.04|0.69|0.1105
71145027|NCT00333775|141783417|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0241|TWO_SIDED|95.0|0.65|0.97|||Log Rank|||||0.97|0.65|0.0241
71145028|NCT00333775|141783418|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.6962|TWO_SIDED|95.0|0.62|1.37|||Log Rank|||||1.37|0.62|0.6962
71145029|NCT00333775|141783418|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0765|TWO_SIDED|95.0|0.45|1.04|||Log Rank|||||1.04|0.45|0.0765
70870759|NCT03000439|141226920|OTHER||Difference in LS Mean|1.84|||||TWO_SIDED|95.0|-1.29|4.97||||||DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.97|-1.29|
70870760|NCT03000439|141226920|OTHER||Difference in LS Mean|-0.08|||||TWO_SIDED|95.0|-5.89|5.72||||||DB Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||5.72|-5.89|
71145030|NCT01856270|141783467|SUPERIORITY|The data from this study was compared with the data from the Natural History of Headache after Mild TBI which was previously published (Lucas, Hoffman, Bell, Dikmen. (2014), A prospective study of prevalence and characterization of headache following mild traumatic brain injury. Cephalalgia (34) 93-102).|Difference of proportions|0.114||||0.101|ONE_SIDED|95.0|-0.017|||A priori significance threshold α=.05|Fisher Exact||Confidence interval estimation method from Wallenstein (1997). 71 of 205 participants (at 3 Mo post) in the Natural History study endorsed having a headache more than once per week.|A positive difference of proportions would indicate an improvement in the Amitriptyline sample, while a negative difference would indicate a worsening.|||-0.017|.101
70952917|NCT05292586|141407376|SUPERIORITY||Odds Ratio (OR)|1.262||||0.18|TWO_SIDED|95.0|0.898|1.772|||Logistic regression model|||2\_Responders at Week 8||1.772|0.898|0.180
70952918|NCT05292586|141407376|SUPERIORITY||Odds Ratio (OR)|1.568||||0.009|TWO_SIDED|95.0|1.117|2.203|||Logistic regression model|||3\_Responders at Week 12||2.203|1.117|0.009
70952919|NCT05292586|141407377|SUPERIORITY||Odds Ratio (OR)|1.822|||<|0.001|TWO_SIDED|95.0|1.284|2.587|||Logistic regression model|||1\_Responders at Week 12||2.587|1.284|<0.001
70952920|NCT05292586|141407378|SUPERIORITY||Adjusted mean difference|8.78||||0.002|TWO_SIDED|95.0|3.3|14.27|||ANCOVA|||"1\_Change From Baseline; Week 0 -- Week 12~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||14.27|3.30|0.002
70952921|NCT05292586|141407379|SUPERIORITY||Adjusted mean difference|8.73||||0.002|TWO_SIDED|95.0|3.32|14.14|||ANCOVA|||"1\_Change From Baseline; Week 0 -- Week 12~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||14.14|3.32|0.002
70952922|NCT05292586|141407380|SUPERIORITY||Adjusted mean difference|-0.112||||0.026|TWO_SIDED|95.0|-0.211|-0.013|||ANCOVA|||"1\_Change From Baseline in ACQ-7 at Week 12~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||-0.013|-0.211|0.026
71145031|NCT01856270|141783468|SUPERIORITY|The data from this study was compared with the data from the Natural History of Headache after Mild TBI which was previously published (Lucas, Hoffman, Bell, Dikmen. (2014), A prospective study of prevalence and characterization of headache following mild traumatic brain injury. Cephalalgia (34) 93-102).|Difference of proportions|0.194||||0.017|ONE_SIDED|95.0|0.057|||A priori significance threshold α=.05|Fisher Exact||Confidence interval estimation method from Wallenstein (1997). 56 of 148 participants (at 3 mo post) in the Natural History study reported pain \>=6.|A positive difference of proportions would indicate an improvement in the Amitriptyline sample, while a negative difference would indicate a worsening|||.057|.017
70952923|NCT05292586|141407380|SUPERIORITY||Adjusted mean difference|0.02||||0.686|TWO_SIDED|95.0|-0.077|0.118|||ANCOVA|||"2\_Change from baseline in ACQ-5 at Week 12~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.118|-0.077|0.686
70952924|NCT05292586|141407381|SUPERIORITY||Adjusted mean difference|3.82||||0.033|TWO_SIDED|95.0|0.31|7.33|||ANCOVA|||"1\_Change From Baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||7.330|0.310|0.033
70952925|NCT05292586|141407382|SUPERIORITY||Adjusted mean difference|3.78||||0.078|TWO_SIDED|95.0|-0.425|7.985|||ANCOVA|||"1\_Change From Baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||7.985|-0.425|0.078
70952926|NCT00515671|141407431|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8868|TWO_SIDED||||||Mixed Models Analysis|||||||.8868
70952927|NCT00515671|141407432|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3328|TWO_SIDED||||||Mixed Models Analysis|||||||.3328
70872257|NCT03782792|141229725|OTHER||Risk Difference (RD)|0.403|||||TWO_SIDED|95.0|0.096|0.607|||||Risk difference=Response rate of spesolimab - response rate of placebo.|Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.607|0.096|
70952928|NCT00288639|141407434|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-22.72|STANDARD_DEVIATION|55.232||||95.0|-34.16|-11.28|||||Response ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-11.28|-34.16|
70952929|NCT00288639|141407435|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-17.26|STANDARD_DEVIATION|48.797||||95.0|-27.36|-7.15|||||Response ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-7.15|-27.36|
70952930|NCT00288639|141407436|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-22.43|STANDARD_DEVIATION|56.615||||95.0|-34.16|-10.71|||||1-28 Days. Response ratio = 100 x \[(t - b)/(t + b)\] where t= 4 wk interval seizure frequency and b=baseline seizure frequency.|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts.Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%.Allowing for dropouts assume 85% pts analyzed.||-10.71|-34.16|
70952931|NCT00288639|141407436|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-22.83|STANDARD_DEVIATION|57.543||||95.0|-34.74|-10.91|||||29-56 Days. Response ratio = 100 x \[(t - b)/(t + b)\] where t= 4 wk interval seizure frequency and b=baseline seizure frequency.|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power,true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-10.91|-34.74|
70952932|NCT00288639|141407436|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-27.18|STANDARD_DEVIATION|59.323||||95.0|-39.9|-14.46|||||57-84 Days. Response ratio = 100 x \[(t - b)/(t + b)\] where t= 4 wk interval seizure frequency and b=baseline seizure frequency. .|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-14.46|-39.90|
70952933|NCT00288639|141407436|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-30.75|STANDARD_DEVIATION|58.11||||95.0|-43.44|-18.06|||||85-112 Days. Response ratio=100 x \[(t - b)/(t + b)\] where t= 4 wk interval seizure frequency and b=baseline seizure frequency.|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%.Allowing for dropouts assume 85% pts analyzed.||-18.06|-43.44|
70952934|NCT00288639|141407436|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-38.75|STANDARD_DEVIATION|59.368||||95.0|-51.79|-25.7|||||113-140 Days. Response ratio=100 x \[(t - b)/(t + b)\] where t= 4 wk interval seizure frequency and b=baseline seizure frequency.|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%.Allowing for dropouts assume 85% pts analyzed.||-25.70|-51.79|
70952935|NCT00288639|141407436|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-44.24|STANDARD_DEVIATION|62.703||||95.0|-58.47|-30.01|||||\>140 Days. Response ratio= 100 x \[(t - b)/(t + b)\] where t= 4 wk interval seizure frequency and b=baseline seizure frequency.|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power,true change from baseline approximately 25%.Allowing for dropouts assume 85% pts analyzed.||-30.01|-58.47|
70952936|NCT00288639|141407437|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|7.19|STANDARD_DEVIATION|84.425||||95.0|-17.6|31.98|||||Simple Partial Seizures. Response ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||31.98|-17.60|
70952937|NCT00288639|141407437|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-22.24|STANDARD_DEVIATION|68.058||||95.0|-37.8|-6.69|||||Complex Partial Seizures. Response ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-6.69|-37.80|
70952938|NCT00288639|141407437|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-23.85|STANDARD_DEVIATION|84.313||||95.0|-55.33|7.64|||||Evolved to Generalized. Response ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||7.64|-55.33|
70952939|NCT00288639|141407441|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-24.93|STANDARD_DEVIATION|60.867||||95.0|-43.66|-6.2|||||Seizure freq. ≤3 / 28 d. Resp. ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-6.20|-43.66|
70952940|NCT00288639|141407441|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-20.78|STANDARD_DEVIATION|50.334||||95.0|-35.24|-6.33|||||Seizure freq. \>3 / 28 d. Resp. ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-6.33|-35.24|
70952941|NCT02385240|141407461|EQUIVALENCE|provides 85% power of success|Equivalence ratio|1.034|||||TWO_SIDED|90.0|-7.52|10.72|||Wald's method|||||10.72|-7.52|
70952942|NCT02385240|141407462|EQUIVALENCE|provides 85% power of success|Equivalence ratio|1.05|||||TWO_SIDED|90.0|-6.94|11.33|||Wald's method|||||11.33|-6.94|
70952943|NCT02385240|141407463|EQUIVALENCE|provides 85% power of success|Equivalence ratio|1.26|||||TWO_SIDED|90.0|-1.77|15.46|||Wald's method|||||15.46|-1.77|
70952944|NCT01014208|141407464|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12||||0.333|TWO_SIDED|95.0|0.89|1.42||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-rank test||The Pike estimator was the statistical method used to estimate the hazard ratio.|||1.42|0.89|0.333
70872258|NCT03782792|141229726|OTHER||Risk Difference (RD)|0.432|||||TWO_SIDED|95.0|0.096|0.636|||||Risk difference=Response rate of spesolimab - response rate of placebo.|Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.636|0.096|
70952945|NCT01014208|141407465|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.4053|TWO_SIDED|95.0|0.56|1.24||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel||For Category title- Independent reviewer-assessed OR|||1.24|0.56|0.4053
71145032|NCT01856270|141783469|SUPERIORITY||Difference of proportions|0.093||||0.456|TWO_SIDED|95.0|-0.106|0.286||A priori significance threshold α=.05|Fisher Exact||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed). Confidence interval estimation method from Wallenstein (1997).|||.286|-.106|.456
70870761|NCT03000439|141226920|OTHER||Difference in LS Mean|-0.69|||||TWO_SIDED|95.0|-3.79|2.41||||||DB Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.41|-3.79|
70952946|NCT01014208|141407465|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.1167|TWO_SIDED|95.0|0.39|1.1||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel||For Category title- Independent reviewer-assessed CR|||1.10|0.39|0.1167
70952947|NCT01014208|141407466|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.8209|TWO_SIDED|95.0|0.55|2.43||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel||For Category title- Independent reviewer-assessed OR|||2.43|0.55|0.8209
70870762|NCT03000439|141226920|OTHER||Difference in LS Mean|-0.35|||||TWO_SIDED|95.0|-1.89|1.19||||||DB Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.19|-1.89|
70952948|NCT01014208|141407466|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.6313|TWO_SIDED|95.0|0.62|2.43||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel||For Category title- Independent reviewer-assessed CR|||2.43|0.62|0.6313
71145033|NCT01856270|141783470|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.684|TWO_SIDED|95.0|-5.1|3.4||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)|||3.4|-5.1|.684
71145034|NCT01856270|141783471|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.306|TWO_SIDED|95.0|-1.0|2.9||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)|||2.9|-1.0|.306
71145035|NCT01856270|141783472|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.583|TWO_SIDED|95.0|-0.9|1.6||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)|||1.6|-0.9|.583
71145036|NCT01856270|141783473|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.444|TWO_SIDED|95.0|-4.0|8.8||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)|||8.8|-4.0|.444
71145037|NCT01856270|141783474|SUPERIORITY||Mean Difference (Final Values)|27.3||||0.041|TWO_SIDED|95.0|1.2|53.3||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)|||53.3|1.2|.041
71145038|NCT01856270|141783475|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.089|TWO_SIDED|95.0|-3.8|0.3||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)|||0.3|-3.8|.089
71145039|NCT01743469|141783520|SUPERIORITY_OR_OTHER|||||||0.142||||||One-sided alpha of 0.1.|Exact binomial test|||The PFS rate was compared with the prespecified threshold (\>20%).||||0.142
71145040|NCT01743469|141783520|SUPERIORITY_OR_OTHER|||||||1||||||One-sided alpha of 0.1.|Exact binomial test|||The PFS rate was compared with the prespecified threshold (\>35%).||||1.000
71145041|NCT01743469|141783520|SUPERIORITY_OR_OTHER|||||||0.8||||||One-sided alpha of 0.1|Exact binomial test|||The PFS rate was compared with the prespecified threshold (\>20%).||||0.800
71145042|NCT01743469|141783520|SUPERIORITY_OR_OTHER|||||||0.63||||||One-sided alpha of 0.1|Exact binomial test|||The PFS rate was compared with the prespecified threshold (\>15%).||||0.630
71145043|NCT01743469|141783521|SUPERIORITY_OR_OTHER|||||||0.5||||||One-sided alpha of 0.1.|Exact binomial test|||The PFS rate was compared with a prespecified threshold (\>20%).||||0.500
71145044|NCT01451606|141783531|SUPERIORITY|||||||0.52||||||Note that sample size was well below our target, making this test very low power.|Wilcoxon (Mann-Whitney)|||||||0.52
71145045|NCT01451606|141783532|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
71145046|NCT01446159|141783571|SUPERIORITY||Hazard Ratio (HR)|0.991||||0.86|TWO_SIDED|95.0|0.689|1.429|||Log Rank|||||1.429|0.689|0.86
71145047|NCT03668873|141783591|SUPERIORITY||Difference of Least Squares Means|-1.85|||<|0.001|TWO_SIDED|95.0|-2.88|-0.81||Threshold for significance was p=0.05.|Mixed Models Analysis|Mixed models with repeated measures with fixed effects for baseline CSI, treatment, week as a categorical variable, and treatment-week interaction.|Treatment difference = SPT minus SPE.|The null hypothesis was that the SPE and SPT groups did not differ on change in CSI score at 10 weeks. Assuming a standard deviation of 2.5 units and an attrition rate of 10%, an enrollment target of 90 participants would provide 90% power to detect a difference of 1.85 points or greater with a type I error rate of 0.05 using a two-tailed two-sample t-test.||-0.81|-2.88|<0.001
71145048|NCT03668873|141783592|SUPERIORITY||Absolute percent difference|24.0||||0.037|TWO_SIDED|95.0|2.0|46.0||Threshold for significance was 0.05|Chi-squared||Difference = SPT minus SPE.|The null hypothesis was that the SPE and SPT groups did not differ on the rate of positive response to CGI-I at 10 weeks. Assuming a 25%-40% positive response rate at 10 weeks in the SPE group and 45 patients per group, power was 90% to detect a 32% or greater difference in positive response rate (57%-72% in SPT group, respectively), with a type I error rate of 0.05 using a Chi-square test.||46|2|0.037
71145049|NCT03668873|141783593|SUPERIORITY|||||||0.81||||||threshold for significant 0.05|Mixed Models Analysis|||||||0.81
71145050|NCT03668873|141783594|SUPERIORITY|||||||0.77||||||Threshold for significance was 0.05|Mixed Models Analysis|||||||0.77
71145051|NCT03668873|141783595|SUPERIORITY|||||||0.003||||||Threshold for significance was 0.05|Mixed Models Analysis|||||||0.003
71145052|NCT02183675|141783597|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|108.39|STANDARD_ERROR_OF_MEAN|1.094|||TWO_SIDED|90.0|93.081|126.225|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-H12.5|||126.225|93.081|
70870763|NCT03000439|141226920|OTHER||Difference in LS Mean|-0.03|||||TWO_SIDED|95.0|-3.63|3.58||||||DB Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||3.58|-3.63|
70870764|NCT03000439|141226920|OTHER||Difference in LS Mean|-2.59|||||TWO_SIDED|95.0|-5.67|0.49||||||DB Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.49|-5.67|
70870765|NCT03000439|141226920|OTHER||Difference in LS Mean|-0.82|||||TWO_SIDED|95.0|-2.82|1.19||||||DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.19|-2.82|
70870766|NCT03000439|141226920|OTHER||Difference in LS Mean|-0.46|||||TWO_SIDED|95.0|-3.27|2.36||||||DB Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.36|-3.27|
70870767|NCT03000439|141226933|OTHER||Difference in LS Mean|0.86|||||TWO_SIDED|95.0|-0.08|1.79||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.79|-0.08|
70870768|NCT03000439|141226933|OTHER||Difference in LS Mean|1.32|||||TWO_SIDED|95.0|0.25|2.4||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||2.40|0.25|
70870769|NCT03000439|141226933|OTHER||Difference in LS Mean|1.43|||||TWO_SIDED|95.0|-0.79|3.66||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||3.66|-0.79|
70870770|NCT03000439|141226933|OTHER||Difference in LS Mean|0.02|||||TWO_SIDED|95.0|-0.7|0.74||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.74|-0.70|
71145053|NCT02183675|141783597|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|114.86|STANDARD_ERROR_OF_MEAN|1.097|||TWO_SIDED|90.0|98.216|134.326|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-A5|||134.326|98.216|
70870771|NCT03000439|141226933|OTHER||Difference in LS Mean|0.11|||||TWO_SIDED|95.0|-0.43|0.64||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.64|-0.43|
70952949|NCT01014208|141407467|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.346|TWO_SIDED|95.0|0.9|1.36||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified log-rank test||Confidence Interval estimated using the Brookmeyer-Crowley method. HR are estimated using Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.|||1.36|0.90|0.346
70870772|NCT03000439|141226933|OTHER||Difference in LS Mean|0.44|||||TWO_SIDED|95.0|0.06|0.81||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.81|0.06|
70870773|NCT03000439|141226933|OTHER||Difference in LS Mean|0.21|||||TWO_SIDED|95.0|-1.64|2.06||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||2.06|-1.64|
70870774|NCT03000439|141226933|OTHER||Difference in LS Mean|0.49|||||TWO_SIDED|95.0|-0.04|1.03||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.03|-0.04|
70870775|NCT03000439|141226933|OTHER||Difference in LS Mean|0.35|||||TWO_SIDED|95.0|-0.09|0.79||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.79|-0.09|
70870776|NCT03000439|141226933|OTHER||Difference in LS Mean|0.52|||||TWO_SIDED|95.0|-0.23|1.28||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.28|-0.23|
70870777|NCT03000439|141226933|OTHER||Difference in LS Mean|-0.19|||||TWO_SIDED|95.0|-1.2|0.83||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.83|-1.20|
70870778|NCT03000439|141226933|OTHER||Difference in LS Mean|0.21|||||TWO_SIDED|95.0|-0.49|0.91||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.91|-0.49|
70870779|NCT03000439|141226933|OTHER||Difference in LS Mean|0.06|||||TWO_SIDED|95.0|-0.8|0.92||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.92|-0.80|
70870780|NCT03000439|141226934|OTHER||Difference in LS Mean|0.29|||||TWO_SIDED|95.0|-0.43|1.0||||||DB Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.00|-0.43|
70870781|NCT03000439|141226934|OTHER||Difference in LS Mean|1.01|||||TWO_SIDED|95.0|-0.06|2.08||||||DB Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.08|-0.06|
70870782|NCT03000439|141226934|OTHER||Difference in LS Mean|1.25|||||TWO_SIDED|95.0|-1.13|3.64||||||DB Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||3.64|-1.13|
70952950|NCT01014208|141407468|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.377|TWO_SIDED|95.0|0.7|1.15||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified log-rank test||Confidence Interval estimated using the Brookmeyer-Crowley method. HR are estimated using Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.|||1.15|0.70|0.377
70952951|NCT01014208|141407469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.57||||0.1161|TWO_SIDED|95.0|0.83|9.5||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel|||||9.50|0.83|0.1161
70952952|NCT01014208|141407470|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.4481|TWO_SIDED|95.0|0.56|1.27||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel||Statistics are presented for Completion rate|||1.27|0.56|0.4481
70952953|NCT01014208|141407471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.978|TWO_SIDED|95.0|-2.11|2.17|||ANCOVA|||||2.170|-2.110|0.978
70952954|NCT01014208|141407472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.129||||0.387|TWO_SIDED|95.0|-1.434|3.691|||ANCOVA|||||3.691|-1.434|0.387
70952955|NCT01014208|141407473|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.479|TWO_SIDED|95.0|0.74|1.16||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Neutrophils, Cycle 1. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.||1.16|0.74|0.479
70952956|NCT01014208|141407473|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.059|TWO_SIDED|95.0|0.64|1.02||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Neutrophils, Cycle 2. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.||1.02|0.64|0.059
70952957|NCT01014208|141407473|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.451|TWO_SIDED|95.0|0.83|1.48||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Neutrophils, Cycle 3. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.||1.48|0.83|0.451
70952958|NCT01014208|141407473|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.597|TWO_SIDED|95.0|0.86|1.29||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Platelets, Cycle 1. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.||1.29|0.86|0.597
70952959|NCT01014208|141407473|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.199|TWO_SIDED|95.0|0.7|1.1||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Platelets, Cycle 2. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.||1.10|0.70|0.199
70952960|NCT01014208|141407473|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||0.102|TWO_SIDED|95.0|0.93|1.59||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Platelets, Cycle 3. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.||1.59|0.93|0.102
70952961|NCT01014208|141407474|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.035|TWO_SIDED|95.0|0.36|1.0||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank||Confidence Interval estimated using the Brookmeyer-Crowley method. HR are estimated using Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.|||1.00|0.36|0.035
70952962|NCT00225017|141407486|NON_INFERIORITY_OR_EQUIVALENCE|25 subjects per arm will have 80% power to detect a difference between groups in mean FMD change of 2.9%, and 90% power to detect a mean FMD change of 3.4%|Mean Difference (Net)|-0.384|STANDARD_DEVIATION|1.0||0.601|TWO_SIDED|95.0|-2.08|1.312|||Wilcoxon (Mann-Whitney)|||||1.312|-2.080|0.601
70952963|NCT00225017|141407487|SUPERIORITY_OR_OTHER||||||<|0.009||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.009
70952964|NCT00225017|141407488|SUPERIORITY_OR_OTHER|||||||0.141||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.141
70952965|NCT01498887|141407523|SUPERIORITY_OR_OTHER|||||||0.3118|||||||Wilcoxon (Mann-Whitney)|||||||0.3118
70952966|NCT03079297|141407530|SUPERIORITY||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|2.5||0.4128|TWO_SIDED|95.0|-3.56|7.56|||t-test, 2 sided|||||7.56|-3.56|0.4128
70952967|NCT03079297|141407531|SUPERIORITY|||||||0.4286|||||||Fisher Exact|||||||0.4286
70952968|NCT03079297|141407532|SUPERIORITY|||||||0.999|||||||Fisher Exact|||||||.999
70952969|NCT03079297|141407533|SUPERIORITY|||||||0.9932||||||P-value for Adverse effect burden 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.9932
70952970|NCT03079297|141407533|SUPERIORITY|||||||0.9932||||||P-value for Adverse effect burden 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.9932
70952971|NCT03079297|141407533|SUPERIORITY|||||||0.2242||||||P-value for Adverse effect burden 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.2242
70952972|NCT03079297|141407534|SUPERIORITY|||||||0.7282||||||P-value for General fatigue 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.7282
70952973|NCT03079297|141407534|SUPERIORITY|||||||0.8781||||||P-value for General fatigue 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.8781
70952974|NCT03079297|141407534|SUPERIORITY|||||||0.226||||||P-value for General fatigue 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.226
70952975|NCT03079297|141407534|SUPERIORITY|||||||0.2158||||||P-value for Mental fatigue 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.2158
70952976|NCT03079297|141407534|SUPERIORITY|||||||0.0081||||||P-value for Mental fatigue 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0081
70952977|NCT03079297|141407534|SUPERIORITY|||||||0.6768||||||P-value for Mental fatigue 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.6768
70952978|NCT03079297|141407534|SUPERIORITY|||||||0.0076||||||P-value for Physical fatigue 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0076
70952979|NCT03079297|141407534|SUPERIORITY|||||||0.0858||||||P-value for Physical fatigue 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0858
70952980|NCT03079297|141407534|SUPERIORITY|||||||0.2065||||||P-value for Physical fatigue 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.2065
70952981|NCT03079297|141407534|SUPERIORITY|||||||0.9712||||||P-value for Reduced motivation 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.9712
70952982|NCT03079297|141407534|SUPERIORITY|||||||0.7572||||||P-value for Reduced motivation 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.7572
70952983|NCT03079297|141407534|SUPERIORITY|||||||0.0588||||||P-value for Reduced motivation 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0588
70952984|NCT03079297|141407534|SUPERIORITY|||||||0.1857||||||P-value for Reduced activity 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.1857
70952985|NCT03079297|141407534|SUPERIORITY|||||||0.9225||||||P-value for Reduced activity 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.9225
70952986|NCT03079297|141407534|SUPERIORITY|||||||0.0414||||||P-value for Reduced activity 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0414
70952987|NCT03079297|141407535|SUPERIORITY|||||||0.4603||||||P-value for Psychosocial function 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.4603
70952988|NCT03079297|141407535|SUPERIORITY|||||||0.2521||||||P-value for Psychosocial function 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.2521
70952989|NCT03079297|141407535|SUPERIORITY|||||||0.6635||||||P-value for Psychosocial function 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.6635
70952990|NCT03079297|141407536|SUPERIORITY|||||||0.7839||||||P-value for Anhedonia 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.7839
70952991|NCT03079297|141407536|SUPERIORITY|||||||0.0248||||||P-value for Anhedonia function 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0248
70952992|NCT03079297|141407536|SUPERIORITY|||||||0.0199||||||P-value for Anhedonia 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0199
70952993|NCT02993406|141407539|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.004|TWO_SIDED|95.0|0.79|0.96|||Log Rank|||||0.96|0.79|0.004
70952994|NCT02993406|141407540|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0058|TWO_SIDED|95.0|0.76|0.96|||Log Rank|||||0.96|0.76|0.0058
70952995|NCT02993406|141407541|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0016|TWO_SIDED|95.0|0.66|0.91|||Log Rank|||||0.91|0.66|0.0016
70952996|NCT02993406|141407542|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0013|TWO_SIDED|95.0|0.72|0.92|||Log Rank|||||0.92|0.72|0.0013
70952997|NCT02993406|141407543|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.1593|TWO_SIDED|95.0|0.67|1.07|||Log Rank|||||1.07|0.67|0.1593
70952998|NCT02993406|141407544|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.6227|TWO_SIDED|95.0|0.88|1.24|||Log Rank|||||1.24|0.88|0.6227
70952999|NCT02993406|141407545|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.6608|TWO_SIDED|95.0|0.9|1.18|||Log Rank|||||1.18|0.90|0.6608
70953000|NCT05262517|141407562|OTHER||Least square (LS) mean difference|-0.15|||||TWO_SIDED|95.0|-1.78|1.48||||||LS means and CIs were estimated by an analysis of covariance (ANCOVA) model, using restricted maximum likelihood (REML) with baseline NRS value as a covariate and treatment group and stratification factor (use of daily medications/ oral devices to reduce the intensity of TMD symptoms) as the main effects.||1.48|-1.78|
70953001|NCT05262517|141407563|OTHER||LS mean difference|5.12|||||TWO_SIDED|95.0|-21.35|31.59||||||LS means and CIs were estimated by an analysis of covariance model using REML with baseline NRS value as a covariate and treatment group and stratification factor (use of daily medications/ oral devices to reduce the intensity of TMD symptoms) as the main effects.||31.59|-21.35|
70953002|NCT05262517|141407564|OTHER||LS mean difference|0.21|||||TWO_SIDED|95.0|-0.99|1.41||||||LS means, and CIs were based on a generalized linear mixed effect model (GLMEM) that included the baseline value as a covariate and fixed effects for treatment group, stratification factor (use of daily medications/ oral devices to reduce the intensity of TMD symptoms; yes or no), scheduled time point, and time point by-treatment group interaction.||1.41|-0.99|
70953003|NCT05262517|141407565|OTHER||Difference in percentage|-5.2|||||TWO_SIDED|95.0|-21.3|10.9||||||Stratified by use of daily medications/ oral devices to reduce the intensity of TMD symptoms at randomization with Mantel-Haenzsel weighting.||10.9|-21.3|
70953004|NCT05262517|141407568|OTHER||Difference in percentage|4.0|||||TWO_SIDED|95.0|-8.7|16.6||||||Stratified by use of daily medications/oral devices to reduce the intensity of TMD symptoms at randomization with Mantel-Haenszel weighting.||16.6|-8.7|
70953005|NCT04325282|141407569|OTHER|||||||0.04||||||The a priori threshold for statistical significance was \<0.05.|Wilcoxon signed rank test|||Within-group analysis of change after active rTMS (post-rTMS compared to pre-rTMS).||||0.04
70953006|NCT04325282|141407569|OTHER|||||||0.46||||||The a priori threshold for statistical significance was \<0.05.|Wilcoxon signed rank test|||Within-group analysis of change after sham rTMS (post-rTMS compared to pre-rTMS).||||0.46
70953007|NCT04325282|141407569|OTHER|||||||0.12||||||The a priori threshold for statistical significance was \<0.05.|Wilcoxon signed rank test|||Between-group analysis of change induced by active rTMS versus sham rTMS||||0.12
70953008|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.|||||<|0.0001||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed-rank test|||Within-group analysis of change in cF-iT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||<0.0001
70870783|NCT03000439|141226934|OTHER||Difference in LS Mean|0.1|||||TWO_SIDED|95.0|-0.68|0.88||||||DB Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.88|-0.68|
70870784|NCT03000439|141226934|OTHER||Difference in LS Mean|-0.13|||||TWO_SIDED|95.0|-0.58|0.33||||||DB Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.33|-0.58|
70870785|NCT03000439|141226934|OTHER||Difference in LS Mean|0.32|||||TWO_SIDED|95.0|-0.03|0.68||||||DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.68|-0.03|
70870786|NCT03000439|141226934|OTHER||Difference in LS Mean|-0.17|||||TWO_SIDED|95.0|-2.42|2.08||||||DB Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.08|-2.42|
70870787|NCT03000439|141226934|OTHER||Difference in LS Mean|0.42|||||TWO_SIDED|95.0|-0.14|0.97||||||DB Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.97|-0.14|
70870788|NCT03000439|141226934|OTHER||Difference in LS Mean|0.32|||||TWO_SIDED|95.0|-0.15|0.79||||||DB Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.79|-0.15|
70870789|NCT03000439|141226934|OTHER||Difference in LS Mean|0.68|||||TWO_SIDED|95.0|-0.14|1.49||||||DB Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.49|-0.14|
70870790|NCT03000439|141226934|OTHER||Difference in LS Mean|-0.16|||||TWO_SIDED|95.0|-1.28|0.96||||||DB Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.96|-1.28|
70870791|NCT03000439|141226934|OTHER||Difference in LS Mean|0.37|||||TWO_SIDED|95.0|-0.43|1.16||||||DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.16|-0.43|
70870792|NCT03000439|141226934|OTHER||Difference in LS Mean|0.24|||||TWO_SIDED|95.0|-0.82|1.3||||||DB Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.30|-0.82|
71145054|NCT02183675|141783598|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|97.53|STANDARD_ERROR_OF_MEAN|1.05|||TWO_SIDED|90.0|90.43|105.19|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-H12.5|||105.19|90.43|
70870793|NCT03000439|141226935|OTHER||Difference in LS Mean|0.21|||||TWO_SIDED|95.0|-0.07|0.5||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.50|-0.07|
70870794|NCT03000439|141226935|OTHER||Difference in LS Mean|0.09|||||TWO_SIDED|95.0|-0.15|0.32||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.32|-0.15|
70870795|NCT03000439|141226935|OTHER||Difference in LS Mean|0.05|||||TWO_SIDED|95.0|-0.17|0.28||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.28|-0.17|
70870796|NCT03000439|141226935|OTHER||Difference in LS Mean|0.1|||||TWO_SIDED|95.0|-0.16|0.36||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.36|-0.16|
70870797|NCT03000439|141226935|OTHER||Difference in LS Mean|0.19|||||TWO_SIDED|95.0|-0.01|0.38||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.38|-0.01|
70870798|NCT03000439|141226935|OTHER||Difference in LS Mean|0.12|||||TWO_SIDED|95.0|-0.12|0.35||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.35|-0.12|
70870799|NCT03000439|141226935|OTHER||Difference in LS Mean|0.07|||||TWO_SIDED|95.0|-0.18|0.31||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.31|-0.18|
70870800|NCT03000439|141226935|OTHER||Difference in LS Mean|0.15|||||TWO_SIDED|95.0|-0.06|0.37||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.37|-0.06|
70870801|NCT03000439|141226935|OTHER||Difference in LS Mean|0.11|||||TWO_SIDED|95.0|-0.14|0.36||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.36|-0.14|
70870802|NCT03000439|141226935|OTHER||Difference in LS Mean|0.16|||||TWO_SIDED|95.0|-0.06|0.38||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.38|-0.06|
70870803|NCT03000439|141226935|OTHER||Difference in LS Mean|0.04|||||TWO_SIDED|95.0|-0.22|0.3||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.30|-0.22|
70870804|NCT03000439|141226935|OTHER||Difference in LS Mean|0.09|||||TWO_SIDED|95.0|-0.2|0.38||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.38|-0.20|
70870805|NCT03000439|141226935|OTHER||Difference in LS Mean|0.09|||||TWO_SIDED|95.0|-0.24|0.42||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.42|-0.24|
70870806|NCT03000439|141226936|OTHER||Difference in LS Mean|0.07|||||TWO_SIDED|95.0|-0.1|0.24||||||DB Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.24|-0.10|
70870807|NCT03000439|141226936|OTHER||Difference in LS Mean|-0.02|||||TWO_SIDED|95.0|-0.19|0.15||||||DB Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.15|-0.19|
70870808|NCT03000439|141226936|OTHER||Difference in LS Mean|-0.01|||||TWO_SIDED|95.0|-0.19|0.16||||||DB Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.16|-0.19|
70870809|NCT03000439|141226936|OTHER||Difference in LS Mean|0.01|||||TWO_SIDED|95.0|-0.2|0.23||||||DB Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.23|-0.20|
70870810|NCT03000439|141226936|OTHER||Difference in LS Mean|0.15|||||TWO_SIDED|95.0|-0.02|0.32||||||DB Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.32|-0.02|
70870811|NCT03000439|141226936|OTHER||Difference in LS Mean|0.15|||||TWO_SIDED|95.0|-0.09|0.4||||||DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.40|-0.09|
70870812|NCT03000439|141226936|OTHER||Difference in LS Mean|0.09|||||TWO_SIDED|95.0|-0.16|0.34||||||DB Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.34|-0.16|
70870813|NCT03000439|141226936|OTHER||Difference in LS Mean|0.15|||||TWO_SIDED|95.0|-0.05|0.36||||||DB Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.36|-0.05|
70870814|NCT03000439|141226936|OTHER||Difference in LS Mean|0.16|||||TWO_SIDED|95.0|-0.1|0.43||||||DB Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.43|-0.10|
70870815|NCT03000439|141226936|OTHER||Difference in LS Mean|0.17|||||TWO_SIDED|95.0|-0.06|0.39||||||DB Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.39|-0.06|
70870816|NCT03000439|141226936|OTHER||Difference in LS Mean|0.04|||||TWO_SIDED|95.0|-0.22|0.3||||||DB Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.30|-0.22|
70870817|NCT03000439|141226936|OTHER||Difference in LS Mean|0.15|||||TWO_SIDED|95.0|-0.18|0.49||||||DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.49|-0.18|
70870818|NCT03000439|141226936|OTHER||Difference in LS Mean|0.16|||||TWO_SIDED|95.0|-0.23|0.55||||||DB Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.55|-0.23|
70953009|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.69||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cF-iT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.69
70870819|NCT03000439|141226937|OTHER||Difference in LS Mean|0.21|||||TWO_SIDED|95.0|-0.97|1.4||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.40|-0.97|
70870820|NCT03000439|141226937|OTHER||Difference in LS Mean|0.58|||||TWO_SIDED|95.0|-0.68|1.84||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.84|-0.68|
70870821|NCT03000439|141226937|OTHER||Difference in LS Mean|1.2|||||TWO_SIDED|95.0|-0.77|3.16||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||3.16|-0.77|
70870822|NCT03000439|141226937|OTHER||Difference in LS Mean|-0.06|||||TWO_SIDED|95.0|-1.3|1.18||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.18|-1.30|
70870823|NCT03000439|141226937|OTHER||Difference in LS Mean|0.26|||||TWO_SIDED|95.0|-0.29|0.82||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||0.82|-0.29|
70870824|NCT03000439|141226937|OTHER||Difference in LS Mean|0.09|||||TWO_SIDED|95.0|-0.46|0.64||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||0.64|-0.46|
70870825|NCT03000439|141226937|OTHER||Difference in LS Mean|-0.46|||||TWO_SIDED|95.0|-2.05|1.13||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.13|-2.05|
70870826|NCT03000439|141226937|OTHER||Difference in LS Mean|0.35|||||TWO_SIDED|95.0|-0.18|0.88||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||0.88|-0.18|
70870827|NCT03000439|141226937|OTHER||Difference in LS Mean|0.31|||||TWO_SIDED|95.0|-0.26|0.88||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||0.88|-0.26|
70870828|NCT03000439|141226937|OTHER||Difference in LS Mean|0.28|||||TWO_SIDED|95.0|-0.43|0.99||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||0.99|-0.43|
70870829|NCT03000439|141226937|OTHER||Difference in LS Mean|0.29|||||TWO_SIDED|95.0|-0.45|1.03||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.03|-0.45|
70870830|NCT03000439|141226937|OTHER||Difference in LS Mean|0.22|||||TWO_SIDED|95.0|-0.63|1.08||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.08|-0.63|
70870831|NCT03000439|141226937|OTHER||Difference in LS Mean|0.45|||||TWO_SIDED|95.0|-0.66|1.57||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.57|-0.66|
70870832|NCT03000439|141226938|OTHER||Difference in LS Mean|-0.13|||||TWO_SIDED|95.0|-0.73|0.47||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.47|-0.73|
70953010|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.|||||<|0.0001||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in cF-iT connectivity induced by active versus sham rTMS.||||<0.0001
71145055|NCT02183675|141783598|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|102.04|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|96.94|107.4|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-A5|||107.40|96.94|
71145056|NCT02183675|141783599|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|104.8|STANDARD_ERROR_OF_MEAN|1.016|||TWO_SIDED|90.0|101.949|107.734|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-H12.5|||107.734|101.949|
70870833|NCT03000439|141226938|OTHER||Difference in LS Mean|0.39|||||TWO_SIDED|95.0|-0.81|1.59||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.59|-0.81|
70870834|NCT03000439|141226938|OTHER||Difference in LS Mean|0.7|||||TWO_SIDED|95.0|-0.54|1.95||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.95|-0.54|
70870835|NCT03000439|141226938|OTHER||Difference in LS Mean|-0.4|||||TWO_SIDED|95.0|-0.9|0.1||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.10|-0.90|
70870836|NCT03000439|141226938|OTHER||Difference in LS Mean|-0.16|||||TWO_SIDED|95.0|-0.46|0.13||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.13|-0.46|
70870837|NCT03000439|141226938|OTHER||Difference in LS Mean|-0.32|||||TWO_SIDED|95.0|-0.63|-0.01||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||-0.01|-0.63|
70870838|NCT03000439|141226938|OTHER||Difference in LS Mean|-1.09|||||TWO_SIDED|95.0|-2.34|0.15||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.15|-2.34|
70870839|NCT03000439|141226938|OTHER||Difference in LS Mean|0.07|||||TWO_SIDED|95.0|-0.26|0.4||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.40|-0.26|
70870840|NCT03000439|141226938|OTHER||Difference in LS Mean|-0.02|||||TWO_SIDED|95.0|-0.3|0.26||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.26|-0.30|
70870841|NCT03000439|141226938|OTHER||Difference in LS Mean|-0.05|||||TWO_SIDED|95.0|-0.53|0.43||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.43|-0.53|
70870842|NCT03000439|141226938|OTHER||Difference in LS Mean|-0.05|||||TWO_SIDED|95.0|-0.56|0.46||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.46|-0.56|
70870843|NCT03000439|141226938|OTHER||Difference in LS Mean|-0.03|||||TWO_SIDED|95.0|-0.74|0.69||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.69|-0.74|
70870844|NCT03000439|141226938|OTHER||Difference in LS Mean|0.2|||||TWO_SIDED|95.0|-0.91|1.32||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.32|-0.91|
70870845|NCT03000439|141226939|OTHER||Difference in LS Mean|1.01|||||TWO_SIDED|95.0|0.09|1.92||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.92|0.09|
71145057|NCT02183675|141783600|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|103.95|STANDARD_ERROR_OF_MEAN|1.017|||TWO_SIDED|90.0|101.023|106.964|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-A5|||106.964|101.023|
71145058|NCT02183675|141783601|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|102.49|STANDARD_ERROR_OF_MEAN|1.014|||TWO_SIDED|90.0|100.167|104.867|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-A5|||104.867|100.167|
71145059|NCT02183675|141783602|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|105.35|STANDARD_ERROR_OF_MEAN|1.036|||TWO_SIDED|90.0|99.23|111.847|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-H12.5|||111.847|99.230|
71145060|NCT02183675|141783603|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|103.39|STANDARD_ERROR_OF_MEAN|1.028|||TWO_SIDED|90.0|98.73|108.28|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-H12.5|||108.280|98.730|
70870846|NCT03000439|141226939|OTHER||Difference in LS Mean|1.31|||||TWO_SIDED|95.0|0.4|2.22||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||2.22|0.40|
71145061|NCT00795535|141783634|SUPERIORITY_OR_OTHER||||||<|0.15|TWO_SIDED|||||To avoid overfitting the models, only predictors with p\<0.15 were included in the final models.|Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum tests were used to compare continuous predictors, whereas chi-square tests were used to compare dichotomized predictors between those with and without serious injury. Test characteristics (specificity and positive/negative predictive values) of continuous predictors were reported based on threshold values chosen for a minimum of 80% of sensitivity. Multiple logistic regression models were used to examine the marginal effect of each predictor.||||< 0.15
71145062|NCT04576988|141783635|OTHER||Treatment difference|40.8|||<|0.001|TWO_SIDED|95.0|27.53|54.14||A 2-sided p-value was calculated using ARSW test with WHO FC II/III and background PAH therapy as strata.|Aligned Rank Stratified Wilcoxon (ARSW)|Participants who died were assigned the worst rank and who had missing data due to non-fatal clinical worsening event were assigned next worst-rank.|Hodges-Lehmann location-shift estimate of the overall treatment difference with 95% confidence interval (CI) was reported.|||54.14|27.53|<0.001
71145063|NCT04576988|141783638|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|A 2-sided p-value was calculated using Cochran-Mantel-Haenszel (CMH) method with WHO FC II/III and background PAH therapy as strata.||||||<0.001
71145064|NCT04576988|141783639|OTHER||Treatment difference|-234.6|||<|0.001|TWO_SIDED|95.0|-288.37|-180.75||A 2-sided p-value was calculated using ARSW test with WHO FC II/III and background PAH therapy as strata.|ARSW test|Participants who died were assigned the worst rank and who had missing data due to non-fatal clinical worsening event were assigned next worst-rank.|Hodges-Lehmann location-shift estimate of the overall treatment difference with 95% CI was reported.|||-180.75|-288.37|<0.001
71145065|NCT04576988|141783640|OTHER||Treatment difference|-441.6|||<|0.001|TWO_SIDED|95.0|-573.54|-309.61||A 2-sided p-value was calculated using ARSW test with WHO FC II/III and background PAH therapy as strata.|ARSW test|Participants who died were assigned the worst rank and who had missing data due to non-fatal clinical worsening event were assigned next worst-rank.|Hodges-Lehmann location-shift estimate of the overall treatment difference with 95% CI was reported.|||-309.61|-573.54|<.001
71145066|NCT04576988|141783641|OTHER|A 2-sided p-value was calculated using CMH method with WHO FC II/III and background PAH therapy as strata.|||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71145067|NCT04576988|141783642|OTHER|A 2-sided p-value was calculated using Log rank test with WHO FC II/III and background PAH therapy as strata.|Hazard Ratio (HR)|0.163|||<|0.001|TWO_SIDED|95.0|0.076|0.347|||Log Rank||Cox proportional hazard model was used to generate hazard ratio (HR) and 95% CI was reported with treatment group as the covariate stratified by the WHO FC II/III and background PAH therapy.|||0.347|0.076|<0.001
71145068|NCT04576988|141783643|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|A 2-sided p-value was calculated using Cochran-Mantel-Haenszel (CMH) method with WHO FC II/III and background PAH therapy as strata.||||||<0.001
71145069|NCT04576988|141783644|OTHER||Treatment difference|-0.26||||0.01|TWO_SIDED|95.0|-0.49|-0.04||A 2-sided p-value was calculated using ARSW test with WHO FC II/III and background PAH therapy as strata.|ARSW test|Participants who died were assigned the worst rank and who had missing data due to non-fatal clinical worsening event were assigned next worst-rank.|Hodges-Lehmann location-shift estimate of the overall treatment difference with 95% CI was reported.|||-0.040|-0.490|0.010
71145070|NCT04576988|141783645|OTHER||Treatment difference|-0.13||||0.028|TWO_SIDED|95.0|-0.256|-0.014||A 2-sided p-value was calculated using ARSW test with WHO FC II/III and background PAH therapy as strata.|ARSW test|Participants who died were assigned the worst rank and who had missing data due to non-fatal clinical worsening event were assigned next worst-rank.|Hodges-Lehmann location-shift estimate of the overall treatment difference with 95% CI was reported.|||-0.014|-0.256|0.028
71145071|NCT04576988|141783646|OTHER||Treatment difference|-0.16||||0.156|TWO_SIDED|95.0|-0.399|0.084||A 2-sided p-value was calculated using ARSW test with WHO FC II/III and background PAH therapy as strata.|ARSW test|Participants who died were assigned the worst rank and who had missing data due to non-fatal clinical worsening event were assigned next worst-rank.|Hodges-Lehmann location-shift estimate of the overall treatment difference with 95% CI was reported.|||0.084|-0.399|0.156
71145072|NCT00617734|141783647|SUPERIORITY_OR_OTHER|||||||0.0667|||||||Log Rank|||||||0.0667
71145073|NCT00617734|141783648|SUPERIORITY_OR_OTHER|||||||0.1935|||||||Fisher Exact|||||||0.1935
71145074|NCT00617734|141783650|SUPERIORITY_OR_OTHER|||||||0.7455|||||||Log Rank|||||||0.7455
70953011|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.|||||<|0.0001||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cM-iT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||<0.0001
70953012|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.43||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cM-iT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.43
70953013|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.|||||<|0.0001||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in cM-iT connectivity induced by active versus sham rTMS.||||<0.0001
70953014|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.002||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-cM connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.002
70953015|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.54||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-cM connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.54
71145075|NCT02485691|141783697|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.|Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.4|0.73||P-value from 2-sided stratified log-rank test, stratified for ECOG performance status, time from AR- targeted agent initiation progression, timing of AR targeted agent as specified at the time of randomization. Significance threshold was at 0.05.|Log Rank||Cabazitaxel vs Abiraterone Acetate or Enzalutamide|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was stratified by ECOG performance status, time from AR- targeted agent initiation progression, timing of AR targeted agent as specified at the time of randomization.||0.73|0.40|<0.0001
70870847|NCT03000439|141226939|OTHER||Difference in LS Mean|0.53|||||TWO_SIDED|95.0|-0.47|1.53||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.53|-0.47|
70870848|NCT03000439|141226939|OTHER||Difference in LS Mean|0.26|||||TWO_SIDED|95.0|-0.63|1.16||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.16|-0.63|
70870849|NCT03000439|141226939|OTHER||Difference in LS Mean|0.32|||||TWO_SIDED|95.0|-0.33|0.97||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||0.97|-0.33|
70870850|NCT03000439|141226939|OTHER||Difference in LS Mean|0.55|||||TWO_SIDED|95.0|-0.1|1.2||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.20|-0.10|
70870851|NCT03000439|141226939|OTHER||Difference in LS Mean|0.2|||||TWO_SIDED|95.0|-0.93|1.33||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.33|-0.93|
70870852|NCT03000439|141226939|OTHER||Difference in LS Mean|0.62|||||TWO_SIDED|95.0|-0.17|1.42||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.42|-0.17|
70870853|NCT03000439|141226939|OTHER||Difference in LS Mean|0.48|||||TWO_SIDED|95.0|-0.02|0.98||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||0.98|-0.02|
70870854|NCT03000439|141226939|OTHER||Difference in LS Mean|0.64|||||TWO_SIDED|95.0|-0.3|1.58||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.58|-0.30|
70870855|NCT03000439|141226939|OTHER||Difference in LS Mean|0.23|||||TWO_SIDED|95.0|-0.4|0.85||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||0.85|-0.40|
70870856|NCT03000439|141226939|OTHER||Difference in LS Mean|0.26|||||TWO_SIDED|95.0|-0.36|0.88||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||0.88|-0.36|
70870857|NCT03000439|141226939|OTHER||Difference in LS Mean|0.11|||||TWO_SIDED|95.0|-0.87|1.09||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.09|-0.87|
70870858|NCT03000439|141226940|OTHER||Difference in LS Mean|-0.05|||||TWO_SIDED|95.0|-0.77|0.67||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.67|-0.77|
70870859|NCT03000439|141226940|OTHER||Difference in LS Mean|0.58|||||TWO_SIDED|95.0|-0.37|1.53||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.53|-0.37|
71145076|NCT02485691|141783698|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.|Hazard Ratio (HR)|0.64||||0.0078|TWO_SIDED|95.0|0.46|0.89||P-value from two-sided stratified log-rank test, stratified for ECOG performance status, time from AR-targeted agent initiation to progression, timing of AR-targeted agent as specified at the time of randomization. Significance threshold = 0.05.|Log Rank||Cabazitaxel vs Abiraterone Acetate or Enzalutamide|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was stratified by ECOG performance status, time from AR- targeted agent initiation progression, timing of AR targeted agent as specified at the time of randomization.||0.89|0.46|0.0078
71145077|NCT02485691|141783699|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.|Hazard Ratio (HR)|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.68||P-value from two-sided stratified log-rank test, stratified for ECOG performance status, time from AR-targeted agent initiation to progression, timing of AR-targeted agent as specified at the time of randomization. Significance threshold = 0.05.|Log Rank||Cabazitaxel vs Abiraterone Acetate or Enzalutamide|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was stratified by ECOG performance status, time from AR- targeted agent initiation progression, timing of AR targeted agent as specified at the time of randomization.||0.68|0.40|<0.0001
71145078|NCT02485691|141783700|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.||||||0.0003||||||Cochran-Mantel-Haenszel test stratified by ECOG performance status, time from AR-targeted agent initiation to progression, timing of AR-targeted agent as specified at the time of randomization. Significance threshold = 0.05.|Cochran-Mantel-Haenszel|||||||0.0003
71145079|NCT02485691|141783701|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.||||||0.0004||||||Cochran-Mantel-Haenszel test stratified by ECOG performance status, time from AR-targeted agent initiation to progression, timing of AR-targeted agent as specified at the time of randomization. Significance threshold = 0.05.|Cochran-Mantel-Haenszel|||||||0.0004
71145080|NCT00310765|141783741|SUPERIORITY_OR_OTHER_LEGACY|The group-by-time interaction result from repeated-measure analysis of variance modeling was used to evaluate whether the two study groups differed regarding the pain score change that occurred across each of the two study phases (weeks 0-7 and weeks 7-10). To conform to the analysis of variance assumption of distributional normality, the pain scores were square root transformed before the analysis.|Mean Difference (Net)|2.0|STANDARD_DEVIATION|1.5|<|0.05|TWO_SIDED|95.0|0.0|4.0|||ANOVA|||The number of patients required per treatment group to achieve a \>80% power with an alpha=0.05 were based on exact rates from reference articles cited in the paper. Patients were randomly assigned to active drug (pregabalin) or look alike placebo.||4.0|0.0|<0.05
71145081|NCT00310765|141783742|SUPERIORITY_OR_OTHER_LEGACY|The group-by-time interaction result from repeated-measures analysis of variance modeling was used to evaluate whether the two study groups differed regarding the sleep score change that occurred during the two study phases (weeks 0-7 and weeks 7-11. to conform to the analysis of variance assumption of distributional normality the sleep scores were square root transformed before the analysis.|Mean Difference (Net)|2.0|STANDARD_DEVIATION|1.5|<|0.05|TWO_SIDED|95.0|0.0|4.0|||ANOVA|||The number of patients required per treatment group to achieve a \>80% power with an alpha=0.05 were based on the exact rates from the reference articles cited in the paper.||4.0|0.0|<0.05
71145082|NCT01247324|141783744|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|0.536|||<|0.0001|TWO_SIDED|95.0|0.4|0.719|||Negative Binomial Model||Rate ratio was calculated as Ocrelizumab ARR/Interferon beta-1a 44 mcg SC ARR.|Adjusted by Geographical Region (US vs. Rest of World) and baseline EDSS (\<4.0 vs. \>=4.0).||0.719|0.4|<0.0001
71145083|NCT01247324|141783745|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57|||=|0.0139|TWO_SIDED|95.0|0.37|0.9|||Log Rank|||Time to onset CDP at week 12||0.90|0.37|= 0.0139
71145084|NCT01247324|141783746|SUPERIORITY_OR_OTHER_LEGACY||Adjusted rate ratio|0.058|||<|0.0001||95.0|0.032|0.104|||Negative Binomial Model||Adjusted by baseline T1 Gd lesion (present or not), baseline EDSS (\<4.0 vs. \>=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.|||0.104|0.032|< 0.0001
71145085|NCT01247324|141783747|SUPERIORITY_OR_OTHER_LEGACY||Adjusted rate ratio|0.229|||<|0.0001||95.0|0.174|0.3|||Negative Binomial Model||Adjusted by baseline T2 lesion (present or not), baseline EDSS (\<4.0 vs. \>=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.|||0.300|0.174|< 0.0001
71145086|NCT01247324|141783748|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (stratified)|1.61|||=|0.0106|TWO_SIDED|95.0|1.11|2.33|||CMH Chi-Squared test (stratified)|CMH (Cochran-Mantel-Haenszel) Chi-Squared test Stratified by Geographical Region (US vs. Rest of World) and Baseline EDSS (\<4.0 vs. \>=4.0)||||2.33|1.11|= 0.0106
71145087|NCT01247324|141783749|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57|||=|0.0278|TWO_SIDED|95.0|0.34|0.95|||Log Rank|||Time to onset CDP at week 24||0.95|0.34|= 0.0278
70870860|NCT03000439|141226940|OTHER||Difference in LS Mean|0.12|||||TWO_SIDED|95.0|-1.06|1.3||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.30|-1.06|
70870861|NCT03000439|141226940|OTHER||Difference in LS Mean|-0.26|||||TWO_SIDED|95.0|-1.27|0.74||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.74|-1.27|
70870862|NCT03000439|141226940|OTHER||Difference in LS Mean|-0.16|||||TWO_SIDED|95.0|-0.83|0.52||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.52|-0.83|
70870863|NCT03000439|141226940|OTHER||Difference in LS Mean|0.05|||||TWO_SIDED|95.0|-0.61|0.71||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.71|-0.61|
70870864|NCT03000439|141226940|OTHER||Difference in LS Mean|-0.1|||||TWO_SIDED|95.0|-1.45|1.25||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.25|-1.45|
70953016|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.007||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iF-cM connectivity induced by active versus sham rTMS.||||0.007
70953017|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.002||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-iT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.002
70953018|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.32||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-iT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.32
70870865|NCT03000439|141226940|OTHER||Difference in LS Mean|0.31|||||TWO_SIDED|95.0|-0.61|1.23||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.23|-0.61|
70870866|NCT03000439|141226940|OTHER||Difference in LS Mean|0.18|||||TWO_SIDED|95.0|-0.34|0.71||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.71|-0.34|
71145088|NCT01247324|141783750|SUPERIORITY_OR_OTHER_LEGACY||Adjusted rate ratio|0.428|||<|0.0001||95.0|0.328|0.557|||Negative Binomial Model||Adjusted by baseline T1-hypointense lesion count, baseline EDSS (\<4.0 vs. \>=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.|||0.557|0.328|< 0.0001
70870867|NCT03000439|141226940|OTHER||Difference in LS Mean|0.36|||||TWO_SIDED|95.0|-0.74|1.46||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.46|-0.74|
70870868|NCT03000439|141226940|OTHER||Difference in LS Mean|-0.09|||||TWO_SIDED|95.0|-0.75|0.56||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.56|-0.75|
70870869|NCT03000439|141226940|OTHER||Difference in LS Mean|0.06|||||TWO_SIDED|95.0|-0.68|0.81||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.81|-0.68|
70870870|NCT03000439|141226940|OTHER||Difference in LS Mean|-0.08|||||TWO_SIDED|95.0|-1.1|0.94||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.94|-1.10|
70870871|NCT03000439|141226941|OTHER||Difference in LS Mean|-1.46|||||TWO_SIDED|95.0|-14.59|11.66||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||11.66|-14.59|
70870872|NCT03000439|141226941|OTHER||Difference in LS Mean|-7.22|||||TWO_SIDED|95.0|-19.62|5.17||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||5.17|-19.62|
70870873|NCT03000439|141226941|OTHER||Difference in LS Mean|-6.61|||||TWO_SIDED|95.0|-19.36|6.14||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||6.14|-19.36|
70870874|NCT03000439|141226941|OTHER||Difference in LS Mean|-8.5|||||TWO_SIDED|95.0|-20.28|3.27||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||3.27|-20.28|
70870875|NCT03000439|141226941|OTHER||Difference in LS Mean|-3.95|||||TWO_SIDED|95.0|-10.53|2.62||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||2.62|-10.53|
70870876|NCT03000439|141226941|OTHER||Difference in LS Mean|-1.44|||||TWO_SIDED|95.0|-8.09|5.21||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||5.21|-8.09|
70870877|NCT03000439|141226941|OTHER||Difference in LS Mean|-4.32|||||TWO_SIDED|95.0|-16.67|8.03||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||8.03|-16.67|
70870878|NCT03000439|141226941|OTHER||Difference in LS Mean|-2.86|||||TWO_SIDED|95.0|-13.97|8.25||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||8.25|-13.97|
70870879|NCT03000439|141226941|OTHER||Difference in LS Mean|-10.95|||||TWO_SIDED|95.0|-24.63|2.73||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||2.73|-24.63|
70870880|NCT03000439|141226941|OTHER||Difference in LS Mean|-4.28|||||TWO_SIDED|95.0|-16.74|8.18||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||8.18|-16.74|
70870881|NCT03000439|141226941|OTHER||Difference in LS Mean|-8.32|||||TWO_SIDED|95.0|-15.2|-1.43||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||-1.43|-15.20|
70870882|NCT03000439|141226941|OTHER||Difference in LS Mean|-4.84|||||TWO_SIDED|95.0|-12.6|2.92||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||2.92|-12.60|
70870883|NCT03000439|141226941|OTHER||Difference in LS Mean|-1.34|||||TWO_SIDED|95.0|-5.16|2.48||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||2.48|-5.16|
70870884|NCT03000439|141226942|OTHER||Difference in LS Mean|-6.05|||||TWO_SIDED|95.0|-16.3|4.19||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.19|-16.30|
70870885|NCT03000439|141226942|OTHER||Difference in LS Mean|-10.46|||||TWO_SIDED|95.0|-21.68|0.77||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.77|-21.68|
70870886|NCT03000439|141226942|OTHER||Difference in LS Mean|-10.86|||||TWO_SIDED|95.0|-23.75|2.03||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.03|-23.75|
70870887|NCT03000439|141226942|OTHER||Difference in LS Mean|-13.15|||||TWO_SIDED|95.0|-25.83|-0.46||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||-0.46|-25.83|
70870888|NCT03000439|141226942|OTHER||Difference in LS Mean|-7.02|||||TWO_SIDED|95.0|-13.56|-0.47||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||-0.47|-13.56|
70870889|NCT03000439|141226942|OTHER||Difference in LS Mean|-4.53|||||TWO_SIDED|95.0|-11.0|1.95||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.95|-11.00|
70870890|NCT03000439|141226942|OTHER||Difference in LS Mean|-9.35|||||TWO_SIDED|95.0|-22.24|3.54||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||3.54|-22.24|
70870891|NCT03000439|141226942|OTHER||Difference in LS Mean|-6.75|||||TWO_SIDED|95.0|-18.34|4.83||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.83|-18.34|
70870892|NCT03000439|141226942|OTHER||Difference in LS Mean|-15.49|||||TWO_SIDED|95.0|-30.36|-0.63||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||-0.63|-30.36|
70870893|NCT03000439|141226942|OTHER||Difference in LS Mean|-7.99|||||TWO_SIDED|95.0|-21.0|5.03||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||5.03|-21.00|
70870894|NCT03000439|141226942|OTHER||Difference in LS Mean|-10.49|||||TWO_SIDED|95.0|-17.67|-3.31||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||-3.31|-17.67|
70870895|NCT03000439|141226942|OTHER||Difference in LS Mean|-5.93|||||TWO_SIDED|95.0|-13.53|1.67||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.67|-13.53|
70870896|NCT03000439|141226942|OTHER||Difference in LS Mean|-2.57|||||TWO_SIDED|95.0|-6.37|1.24||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.24|-6.37|
70870897|NCT03000439|141226943|OTHER||Difference in LS Mean|0.51|||||TWO_SIDED|95.0|0.2|2.22||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||2.22|0.20|
70870898|NCT03000439|141226943|OTHER||Difference in LS Mean|0.82|||||TWO_SIDED|95.0|-0.2|1.85||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.85|-0.20|
70870899|NCT03000439|141226943|OTHER||Difference in LS Mean|0.31|||||TWO_SIDED|95.0|-0.65|1.27||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.27|-0.65|
70870900|NCT03000439|141226943|OTHER||Difference in LS Mean|0.57|||||TWO_SIDED|95.0|-0.26|1.41||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.41|-0.26|
70870901|NCT03000439|141226943|OTHER||Difference in LS Mean|0.16|||||TWO_SIDED|95.0|-0.78|1.1||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.10|-0.78|
70870902|NCT03000439|141226943|OTHER||Difference in LS Mean|0.66|||||TWO_SIDED|95.0|-0.18|1.49||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.49|-0.18|
70870903|NCT03000439|141226943|OTHER||Difference in LS Mean|-0.08|||||TWO_SIDED|95.0|-1.43|1.27||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.27|-1.43|
70870904|NCT03000439|141226943|OTHER||Difference in LS Mean|-0.07|||||TWO_SIDED|95.0|-0.65|0.5||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.50|-0.65|
70870905|NCT03000439|141226943|OTHER||Difference in LS Mean|0.06|||||TWO_SIDED|95.0|-0.51|0.63||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.63|-0.51|
70870906|NCT03000439|141226943|OTHER||Difference in LS Mean|-0.04|||||TWO_SIDED|95.0|-0.55|0.47||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.47|-0.55|
70870907|NCT03000439|141226943|OTHER||Difference in LS Mean|-0.16|||||TWO_SIDED|95.0|-0.82|0.5||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.50|-0.82|
70870908|NCT03000439|141226943|OTHER||Difference in LS Mean|-0.14|||||TWO_SIDED|95.0|-1.51|1.22||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.22|-1.51|
70870909|NCT03000439|141226943|OTHER||Difference in LS Mean|-0.08|||||TWO_SIDED|95.0|-1.05|0.88||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.88|-1.05|
70870910|NCT03000439|141226944|OTHER||Difference in LS Mean|0.49|||||TWO_SIDED|95.0|-0.32|1.3||||||DB at Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.30|-0.32|
70953019|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.01||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iF-iT connectivity induced by active versus sham rTMS.||||0.01
70870911|NCT03000439|141226944|OTHER||Difference in LS Mean|0.48|||||TWO_SIDED|95.0|-0.64|1.61||||||DB at Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.61|-0.64|
70870912|NCT03000439|141226944|OTHER||Difference in LS Mean|0.03|||||TWO_SIDED|95.0|-1.02|1.07||||||DB at Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.07|-1.02|
70870913|NCT03000439|141226944|OTHER||Difference in LS Mean|0.23|||||TWO_SIDED|95.0|-0.69|1.14||||||DB at Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.14|-0.69|
70870914|NCT03000439|141226944|OTHER||Difference in LS Mean|0.09|||||TWO_SIDED|95.0|-1.05|1.22||||||DB at Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.22|-1.05|
70870915|NCT03000439|141226944|OTHER||Difference in LS Mean|0.28|||||TWO_SIDED|95.0|-0.6|1.16||||||DB at Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.16|-0.60|
70870916|NCT03000439|141226944|OTHER||Difference in LS Mean|0.02|||||TWO_SIDED|95.0|-1.6|1.64||||||DB at Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.64|-1.60|
70870917|NCT03000439|141226944|OTHER||Difference in LS Mean|0.02|||||TWO_SIDED|95.0|-1.6|1.64||||||DB at Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.64|-1.60|
70870918|NCT03000439|141226944|OTHER||Difference in LS Mean|0.07|||||TWO_SIDED|95.0|-0.58|0.73||||||DB at Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.73|-0.58|
70870919|NCT03000439|141226944|OTHER||Difference in LS Mean|0.06|||||TWO_SIDED|95.0|-0.53|0.65||||||DB at Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.65|-0.53|
70870920|NCT03000439|141226944|OTHER||Difference in LS Mean|-0.12|||||TWO_SIDED|95.0|-0.87|0.64||||||DB at Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.64|-0.87|
70872259|NCT03782792|141229728|OTHER||Risk Difference (RD)|0.151|||||TWO_SIDED|95.0|-0.138|0.401|||||Risk difference=Response rate of spesolimab - response rate of placebo.|Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.401|-0.138|
71145089|NCT01247324|141783751|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|0.039|STANDARD_ERROR_OF_MEAN|0.039|=|0.3261|TWO_SIDED|95.0|-0.039|0.116|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix.|Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.|||0.116|-0.039|= 0.3261
70870921|NCT03000439|141226944|OTHER||Difference in LS Mean|0.21|||||TWO_SIDED|95.0|-1.13|1.54||||||DB at Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.54|-1.13|
70870922|NCT03000439|141226944|OTHER||Difference in LS Mean|0.05|||||TWO_SIDED|95.0|-1.0|1.11||||||DB at Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.11|-1.00|
70870923|NCT03000439|141226947|OTHER||Difference in LS Mean|6.0|||||TWO_SIDED|95.0|-8.35|20.36||||||CHQ01-Global Health Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||20.36|-8.35|
70870924|NCT03000439|141226947|OTHER||Difference in LS Mean|2.85|||||TWO_SIDED|95.0|-12.43|18.14||||||CHQ01-Global Health Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||18.14|-12.43|
70870925|NCT03000439|141226947|OTHER||Difference in LS Mean|-4.19|||||TWO_SIDED|95.0|-15.78|7.4||||||CHQ01-Physical Functioning Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||7.40|-15.78|
70870926|NCT03000439|141226947|OTHER||Difference in LS Mean|2.31|||||TWO_SIDED|95.0|-37.06|41.68||||||CHQ01-Physical Functioning Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||41.68|-37.06|
70870927|NCT03000439|141226947|OTHER||Difference in LS Mean|-5.47|||||TWO_SIDED|95.0|-17.37|6.43||||||CHQ01-Social Limitations: Emotional Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||6.43|-17.37|
70870928|NCT03000439|141226947|OTHER||Difference in LS Mean|6.82|||||TWO_SIDED|95.0|-20.92|34.57||||||CHQ01-Social Limitations: Emotional Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||34.57|-20.92|
70870929|NCT03000439|141226947|OTHER||Difference in LS Mean|-6.22|||||TWO_SIDED|95.0|-18.95|6.5||||||CHQ01-Social Limitations: Physical Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||6.50|-18.95|
70870930|NCT03000439|141226947|OTHER||Difference in LS Mean|11.09|||||TWO_SIDED|95.0|-46.24|68.42||||||CHQ01-Social Limitations: Physical Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||68.42|-46.24|
70870931|NCT03000439|141226947|OTHER||Difference in LS Mean|-1.45|||||TWO_SIDED|95.0|-13.97|11.06||||||CHQ01-Bodily Pain Subscale Standardized Score: DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||11.06|-13.97|
70870932|NCT03000439|141226947|OTHER||Difference in LS Mean|17.2|||||TWO_SIDED|95.0|-28.01|62.41||||||CHQ01-Bodily Pain Subscale Standardized Score: DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||62.41|-28.01|
70870933|NCT03000439|141226947|OTHER||Difference in LS Mean|-5.15|||||TWO_SIDED|95.0|-13.24|2.93||||||CHQ01-Behavior Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.93|-13.24|
70870934|NCT03000439|141226947|OTHER||Difference in LS Mean|-15.03|||||TWO_SIDED|95.0|-33.12|3.06||||||CHQ01-Behavior Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||3.06|-33.12|
70870935|NCT03000439|141226947|OTHER||Difference in LS Mean|-5.32|||||TWO_SIDED|95.0|-16.92|6.29||||||CHQ01-Global Behavior Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||6.29|-16.92|
70870936|NCT03000439|141226947|OTHER||Difference in LS Mean|-7.24|||||TWO_SIDED|95.0|-20.35|5.87||||||CHQ01-Global Behavior Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||5.87|-20.35|
70870937|NCT03000439|141226947|OTHER||Difference in LS Mean|4.44|||||TWO_SIDED|95.0|-6.18|15.07||||||CHQ01-Mental Health Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||15.07|-6.18|
70870938|NCT03000439|141226947|OTHER||Difference in LS Mean|-7.46|||||TWO_SIDED|95.0|-24.37|9.45||||||CHQ01-Mental Health Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||9.45|-24.37|
70870939|NCT03000439|141226947|OTHER||Difference in LS Mean|-0.01|||||TWO_SIDED|95.0|-9.14|9.13||||||CHQ01-Self Esteem Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||9.13|-9.14|
70953020|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.003||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-cF connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.003
70953021|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.29||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-cF connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.29
71145090|NCT01247324|141783752|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|0.168|STANDARD_ERROR_OF_MEAN|0.058|=|0.0042|TWO_SIDED|95.0|0.053|0.283|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix.|Difference in the rate of brain volume loss: 22.8%. Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.|||0.283|0.053|= 0.0042
71145091|NCT01247324|141783753|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|0.693|STANDARD_ERROR_OF_MEAN|0.564|=|0.2193|TWO_SIDED|95.0|-0.414|1.8|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures using unstructured covariance matrix.|Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.|||1.800|-0.414|= 0.2193
71145092|NCT01247324|141783754|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (stratified)|1.74|||<|0.0001|TWO_SIDED|95.0|1.39|2.17|||CMH Chi-Squared test (stratified)|Analyzed using CMH test, stratified by Geographical Region (US vs. rest-of-world) and baseline EDSS (\<4.0 vs. \>=4.0).||||2.17|1.39|< 0.0001
71145093|NCT02764385|141783775|SUPERIORITY||Odds Ratio (OR)|1.87|||||TWO_SIDED|95.0|1.73|2.01||||||||2.01|1.73|
71145094|NCT02764385|141783775|SUPERIORITY||Odds Ratio (OR)|0.68||||0.05|TWO_SIDED|95.0|0.45|1.02|||Regression, Logistic|We adjust for clustering of visit within clinician and clinical site and the stepped wedge study design using generalized estimating equation methods.||||1.02|.45|.05
71145095|NCT02764385|141783776|SUPERIORITY||Odds Ratio (OR)|1.87|||||TWO_SIDED|95.0|1.73|2.1||||||||2.10|1.73|
71145096|NCT04607668|141783801|OTHER||Mean Difference (Final Values)|-1.2|||<|0.001|TWO_SIDED|95.0|-1.7|-0.6||Two-sided p-value for treatment effect was generated from a nonparametric ANCOVA controlling for stratification factors of Region and Prior chemotherapy with study baseline ANC value as a covariate.|ANCOVA|||||-0.6|-1.7|<0.001
71145097|NCT04607668|141783802|OTHER||aRR|0.04|STANDARD_ERROR_OF_MEAN|0.032|<|0.001|TWO_SIDED|95.0|0.01|0.19|||modified Poisson model|||||0.19|0.01|<0.001
71145098|NCT01488045|141783816|EQUIVALENCE|We compared patient satisfaction for those receiving the 2 sedation regimens using the Schuirmann 2 one-sided t test procedure.15 The groups were declared to be equivalent in terms of patient satisfaction if the 90% CI for the difference in mean satisfaction had outer boundaries indicating \<5% difference on the 100-point VAS. Nonequivalence was declared if the lower 90% CI boundary for the difference was less than -5.0, or if the upper 90% CI boundary for the difference was \>5.0.|Mean Difference (Final Values)|-14.0741|STANDARD_DEVIATION|22.2|||TWO_SIDED|95.0|-18.5|-9.6||||||To calculate the required sample size for this study, the equivalence limit was set at 5 units difference on the VAS, with an expected mean difference of 0. The common SD of 16.2 was estimated based on the range of expected scores for the VAS from Ulmer et al. Using these inputs, a total sample size of 262 patients was estimated to have 80% power to reject the null hypothesis that the test and standard were not equivalent and conclude that they were equivalent.||-9.6|-18.5|
71145099|NCT00989911|141783822|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
71145100|NCT02212015|141783829|OTHER||Rate|0.46|||||TWO_SIDED|||||||||Question is, if 6 months progression free survival rate (PFS-R) denoted by pPFS is higher than 35%. Test hypothesis is thus formulated as: H0: pPFS ≤0.35 versus H1: pPFS ≥0.35. This hypothesis is tested at the one-side significance level of 0.05. A 6 months PFS-R of 0.55 of cases or more is considered as clinically relevant success rate. The design is chosen such that rates of 0.55 or higher can be detected with a power of at least 0.8.||||
71145101|NCT02212015|141783830|SUPERIORITY||Rate difference|0.486|||||TWO_SIDED|||||||||||||
71145102|NCT02212015|141783831|SUPERIORITY||Rate difference|0.0|||||TWO_SIDED|||||||||||||
71145103|NCT02212015|141783832|OTHER||Median|21.6|||||TWO_SIDED|||||||||"The analysis of secondary endpoints is of descriptive nature and generally consists of summary statistics and interval estimation.~Overall survival (OS) was defined as the time of start of treatment until death (event status=1) or last contact (censoring, event status=0). OS was analyzed using Kaplan-Meier curves. Median survival time is provided alonsgside two-sided 95% confidence interval (CI), if possible."||||
71145104|NCT02212015|141783833|SUPERIORITY|||||||0.752|||||||Log Rank|||"The analysis of secondary endpoints is of descriptive nature and generally consists of summary statistics and interval estimation.~Overall survival (OS) for subgroup 1 was defined as the time of start of treatment until death (event status=1) or last contact (censoring, event status=0). OS was analyzed using Kaplan-Meier curves. Median survival time is provided alonsgside two-sided 95% confidence interval (CI), if possible."||||0.752
71145105|NCT02212015|141783834|SUPERIORITY|||||||0.621|||||||Log Rank|||"The analysis of secondary endpoints is of descriptive nature and generally consists of summary statistics and interval estimation.~Overall survival (OS) for subgroup 2 was defined as the time of start of treatment until death (event status=1) or last contact (censoring, event status=0). OS was analyzed using Kaplan-Meier curves. Median survival time is provided alonsgside two-sided 95% confidence interval (CI), if possible."||||0.621
71145106|NCT02212015|141783835|OTHER||||||||||||||||||Frequency of each category is given|||
71145107|NCT02212015|141783836|SUPERIORITY|||||||0.349|||||||Chi squared test, exact|||Response Rate (RR) is given as Best Overall Response (BOR) and given be absolute and relative frequencies. Categories of BOR are CR, PR, SD, PD and NE)|Response Rate (RR) is given as Best Overall Response (BOR) and given be absolute and relative frequencies applied to the total of 26 enrolled subjects.. Categories of BOR are CR, PR, SD, PD and NE).|||0.349
71145108|NCT02212015|141783837|SUPERIORITY|||||||0.385|||||||Chi squared test, exact|||||||0.385
70953022|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.02||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iF-cF connectivity induced by active versus sham rTMS.||||0.02
71145109|NCT03448406|141783853|SUPERIORITY||Median difference (HL-estimate)|4.0||||0.366|TWO_SIDED|95.0|-5.0|13.0|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodge-Lehman (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of Placebo and the effect of empagliflozin.||13.0|-5.0|0.3660
71145110|NCT03448406|141783854|SUPERIORITY||Median difference (HL-estimate)|2.08||||0.2783|TWO_SIDED|95.0|-2.08|6.25|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodges-Lehmann estimate for the median difference was calculated.|H0: There is no difference between the effect of Placebo and the effect of empagliflozin.||6.25|-2.08|0.2783
70953023|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.003||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iM-cT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.003
70953024|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.66||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iM-cT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.66
70953025|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.008||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iM-cT connectivity induced by active versus sham rTMS.||||0.008
70870940|NCT03000439|141226947|OTHER||Difference in LS Mean|-7.59|||||TWO_SIDED|95.0|-33.87|18.7||||||CHQ01-Self Esteem Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||18.70|-33.87|
70870941|NCT03000439|141226947|OTHER||Difference in LS Mean|4.98|||||TWO_SIDED|95.0|-4.81|14.77||||||CHQ01-General Health Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||14.77|-4.81|
70870942|NCT03000439|141226947|OTHER||Difference in LS Mean|-1.02|||||TWO_SIDED|95.0|-20.31|18.28||||||CHQ01-General Health Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||18.28|-20.31|
70870943|NCT03000439|141226947|OTHER||Difference in LS Mean|-0.03|||||TWO_SIDED|95.0|-0.4|0.33||||||CHQ01-Change in Health Subscale Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.33|-0.40|
70870944|NCT03000439|141226947|OTHER||Difference in LS Mean|0.48|||||TWO_SIDED|95.0|-0.68|1.65||||||CHQ01-Change in Health Subscale Score; DB Week48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.65|-0.68|
70870945|NCT03000439|141226947|OTHER||Difference in LS Mean|2.25|||||TWO_SIDED|95.0|-10.59|15.1||||||CHQ01-Emotional Impact on Parent Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||15.10|-10.59|
70870946|NCT03000439|141226947|OTHER||Difference in LS Mean|-25.07|||||TWO_SIDED|95.0|-60.96|10.82||||||CHQ01-Emotional Impact on Parent Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||10.82|-60.96|
70870947|NCT03000439|141226947|OTHER||Difference in LS Mean|1.87|||||TWO_SIDED|95.0|-13.55|17.29||||||CHQ01-Time Impact on Parent Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||17.29|-13.55|
70870948|NCT03000439|141226947|OTHER||Difference in LS Mean|-9.19|||||TWO_SIDED|95.0|-48.91|30.53||||||CHQ01-Time Impact on Parent Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||30.53|-48.91|
70870949|NCT03000439|141226947|OTHER||Difference in LS Mean|-3.97|||||TWO_SIDED|95.0|-12.84|4.9||||||CHQ01-Family Activities Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.90|-12.84|
70870950|NCT03000439|141226947|OTHER||Difference in LS Mean|-9.3|||||TWO_SIDED|95.0|-32.35|13.75||||||CHQ01-Family Activities Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||13.75|-32.35|
70870951|NCT03000439|141226947|OTHER||Difference in LS Mean|-3.52|||||TWO_SIDED|95.0|-14.84|7.81||||||CHQ01-Family Cohesion Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||7.81|-14.84|
70870952|NCT03000439|141226947|OTHER||Difference in LS Mean|-20.42|||||TWO_SIDED|95.0|-79.03|38.18||||||CHQ01-Family Cohesion Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||38.18|-79.03|
70870953|NCT03000439|141226950|OTHER||Difference in LS Mean|-0.24|||||TWO_SIDED|95.0|-1.02|0.54||||||CHAQ-Discomfort Index at Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.54|-1.02|
70953026|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.005||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-cT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.005
70953027|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.87||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-cT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.87
71145111|NCT03448406|141783855|SUPERIORITY||Median difference (HL-estimate)|-0.07||||0.5512|TWO_SIDED|95.0|-0.35|0.2|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodges-Lehmann (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of Placebo and the effect of empagliflozin.||0.20|-0.35|0.5512
70870954|NCT03000439|141226950|OTHER||Difference in LS Mean|0.54|||||TWO_SIDED|95.0|-0.49|1.57||||||CHAQ-Discomfort Index at Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.57|-0.49|
71145112|NCT03448406|141783856|SUPERIORITY||Median Difference (HL-estimate)|3.0||||0.3657|TWO_SIDED|95.0|-4.0|11.0|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodges-Lehmann (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of Placebo and the effect of empagliflozin.||11.0|-4.0|0.3657
71145113|NCT03448406|141783857|OTHER||Difference of adjusted mean|-0.09|STANDARD_DEVIATION|0.11||0.444|TWO_SIDED|95.0|-0.31|0.14|||Mixed Model Repeated Measure (MMRM)|Covariates: visit-by-treatment interaction, baseline-by-visit interaction. Unstructured covariance structure was used to model within-patient errors.||||0.14|-0.31|0.4440
71145114|NCT03448406|141783858|OTHER|||||||0.3924|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.3924
71145115|NCT03448406|141783859|OTHER|||||||0.4435|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.4435
71145116|NCT03448406|141783860|OTHER|||||||0.5124|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.5124
71145117|NCT03448406|141783861|OTHER|||||||0.5713|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.5713
71145118|NCT03448406|141783862|OTHER||Adjusted geometric mean ratio|0.95||||0.4032|TWO_SIDED|95.0|0.85|1.07|||Mixed model repeated Measure (MMRM)|Covariates: Visit-by-treatment interaction and baseline-by-visit interaction. Unstructured covariance structure to model within-patient errors.|Adjusted geometric mean ratio \[Empagliflozin/Placebo\] of relative change to baseline.|||1.07|0.85|0.4032
71145119|NCT03405792|141783863|OTHER|||||||||||||||||We will use one-sample log-rank test to compare PFS between the triple combination arm relative to the historical control arm.|We took a look at median survival time and CI of our population and we compared it to the median PFS and CI of the historical control descriptively. There is no yielded P value.|||
71145120|NCT03405792|141783864|OTHER||||||||||||||||||Every participant (26/26; 100%) experienced an adverse event.|||
71145121|NCT03882021|141783876|OTHER||Kaplan Meier Survival Estimate|57.2|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|51.2|62.8|||||Kaplan-Meier estimate of freedom from recurrence after removal from AAD at one year.|||62.8|51.2|
71145122|NCT03882021|141783877|OTHER|Kaplan Meier Estimate of freedom from symptomatic recurrence.|Kaplan-Meier Survival Estimate|61.7|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|55.8|67.1|||||Kaplan-Meier estimate of freedom from symptomatic AF/AFL/AT recurrence after removal from AAD|||67.1|55.8|
71145123|NCT03882021|141783878|OTHER|Kaplan Meier estimate of single procedure clinical success.|Kaplan-Meier Survival Estimate|79.4|STANDARD_ERROR_OF_MEAN|2.4|||TWO_SIDED|95.0|74.2|83.6|||||Kaplan-Meier estimate of freedom from symptomatic AF/AFL/AT without new or increased dose of Class I/III AAD at one year.|||83.6|74.2|
71145124|NCT03882021|141783879|OTHER|Kaplan Meier estimate of freedom from AF/AFL/AT|Kaplan Meier Survival Estimate|75.5|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|95.0|69.9|80.1|||||Kaplan Meier estimate of freedom from AF/AFL/AT at 12 months.|||80.1|69.9|
71145125|NCT03186209|141783885|SUPERIORITY||Rate Ratio|0.26|||<|0.0001|TWO_SIDED|95.0|0.19|0.36||Multiplicity protected by hierarchy testing procedure. First in line hypothesis testing, requiring p-value \<0.05.|Negative binomial|Model with covariates: treatment group, region (China/Non-China), number of exacerbations in previous year, use of maintenance oral corticosteroids||||0.36|0.19|<0.0001
71145126|NCT03186209|141783886|SUPERIORITY||Mean Difference (Final Values)|0.25|||<|0.0001|TWO_SIDED|95.0|0.17|0.34||Test after significant primary endpoint. Two secondary endpoints (change in FEV1 and total asthma symptom score) using Holm's procedure; smaller p-value to be \<0.025, and larger p-value to be \<0.05.|Mixed Models Analysis|Model includes Treatment, baseline pre-bronchodilator FEV1, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||0.34|0.17|<0.0001
71145127|NCT03186209|141783887|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.0126|TWO_SIDED|95.0|-0.45|-0.05||Test after significant primary endpoint. Two secondary endpoints (change in FEV1 and total asthma symptom score) using Holm's procedure; smaller p-value to be \<0.025, and larger p-value to be \<0.05.|Mixed Models Analysis|Model includes Treatment, baseline total asthma symptom score, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||-0.05|-0.45|0.0126
71145128|NCT03186209|141783888|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.1835|TWO_SIDED|95.0|-0.42|0.08||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline total asthma rescue medication use, region, use of maintenance oral corticosteroids, visit, treatment\*visit||||0.08|-0.42|0.1835
71145129|NCT03186209|141783889|SUPERIORITY||Mean Difference (Final Values)|38.66|||<|0.0001|TWO_SIDED|95.0|24.24|53.07||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline morning PEF, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||53.07|24.24|<0.0001
71145130|NCT03186209|141783890|SUPERIORITY||Mean Difference (Final Values)|35.85|||<|0.0001|TWO_SIDED|95.0|21.52|50.18||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline evening PEF, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||50.18|21.52|<0.0001
70953028|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.11||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iF-cT connectivity induced by active versus sham rTMS.||||0.11
70953029|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.012||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-iM connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.012
70953030|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.46||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-iM connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.46
70953031|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.02||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iF-iM connectivity induced by active versus sham rTMS.||||0.02
70953032|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.01||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iT-cT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.01
70953033|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.99||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iT-cT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.99
70953034|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.04||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iT-cT connectivity induced by active versus sham rTMS.||||0.04
70953035|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.01||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cF-cT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.01
70953036|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.31||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cF-cT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.31
71145131|NCT03186209|141783891|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.3385|TWO_SIDED|95.0|-0.03|0.01||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline proportion of nights awakening, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||0.01|-0.03|0.3385
70953037|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.05||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in cF-cT connectivity induced by active versus sham rTMS.||||0.05
70953038|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.03|||||||Wilcoxon signed rank test|The threshold for statistical significance was p \< 0.0076.||Within-group analysis of change in cF-cM connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.03
71145132|NCT03186209|141783892|SUPERIORITY||Mean Difference (Final Values)|-0.43|||<|0.0001|TWO_SIDED|95.0|-0.58|-0.28||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline ACQ-6 score, use of maintenance oral corticosteroids, visit, and treatment by visit||||-0.28|-0.58|<0.0001
71145133|NCT03186209|141783893|SUPERIORITY||Hazard Ratio (HR)|0.32|||<|0.0001|TWO_SIDED|95.0|0.23|0.43||Nominal p-value. Not multiplicity protected by testing procedure.|Regression, Cox|model including covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||0.43|0.23|<0.0001
70870955|NCT03000439|141226950|OTHER||Difference in LS Mean|0.47|||||TWO_SIDED|95.0|-1.01|0.9||||||CHAQ-Discomfort Index at Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.90|-1.01|
70870956|NCT03000439|141226950|OTHER||Difference in LS Mean|0.55|||||TWO_SIDED|95.0|-0.49|1.58||||||CHAQ-Discomfort Index at Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.58|-0.49|
70870957|NCT03000439|141226950|OTHER||Difference in LS Mean|0.23|||||TWO_SIDED|95.0|-0.98|1.45||||||CHAQ-Discomfort Index at Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.45|-0.98|
70870958|NCT03000439|141226950|OTHER||Difference in LS Mean|0.32|||||TWO_SIDED|95.0|-0.51|1.14||||||CHAQ-Discomfort Index at Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.14|-0.51|
70870959|NCT03000439|141226950|OTHER||Difference in LS Mean|-0.42|||||TWO_SIDED|95.0|-1.87|1.03||||||CHAQ-Discomfort Index at Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.03|-1.87|
70870960|NCT03000439|141226950|OTHER||Difference in LS Mean|-0.33|||||TWO_SIDED|95.0|-1.53|0.88||||||CHAQ-Discomfort Index at Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.88|-1.53|
70953039|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.2||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cF-cM connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.20
70870961|NCT03000439|141226950|OTHER||Difference in LS Mean|-0.31|||||TWO_SIDED|95.0|-1.36|0.74||||||CHAQ-Discomfort Index at Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.74|-1.36|
70870962|NCT03000439|141226950|OTHER||Difference in LS Mean|0.07|||||TWO_SIDED|95.0|-0.55|0.69||||||CHAQ-Discomfort Index at Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.69|-0.55|
70870963|NCT03000439|141226950|OTHER||Difference in LS Mean|-0.31|||||TWO_SIDED|95.0|-1.01|0.39||||||CHAQ-Discomfort Index at Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.39|-1.01|
70870964|NCT03000439|141226950|OTHER||Difference in LS Mean|0.23|||||TWO_SIDED|95.0|-1.45|1.92||||||CHAQ-Discomfort Index at Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.92|-1.45|
70870965|NCT03000439|141226950|OTHER||Difference in LS Mean|-0.09|||||TWO_SIDED|95.0|-0.87|0.69||||||CHAQ-Discomfort Index at Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.69|-0.87|
71145134|NCT03186209|141783894|SUPERIORITY||Odds Ratio (OR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.19|0.42||Nominal p-value. Not multiplicity protected by testing procedure.|Cochran-Mantel-Haenszel|Controlling for region, number of exacerbations in the previous year (2, \>=3), use of OCS||||0.42|0.19|<0.0001
71145135|NCT03186209|141783895|SUPERIORITY||Mean Difference (Final Values)|-9.19|||<|0.0001|TWO_SIDED|95.0|-12.79|-5.6||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model with covariates: treatment group, baseline SGRQ total score, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||-5.60|-12.79|<0.0001
71145136|NCT03186209|141783896|SUPERIORITY||Rate ratio|0.46||||0.0222|TWO_SIDED|95.0|0.24|0.9||Nominal p-value. Not multiplicity protected by testing procedure.|Negative binomial|Model includes Treatment, use of maintenance oral corticosteroids, categorical variable of ER/UC or hospitalization exacerbations during previous year||||0.90|0.24|0.0222
70870966|NCT03000439|141226959|OTHER||Difference in percentage|-30.18|||||TWO_SIDED|95.0|-53.43|-6.94|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 4||-6.94|-53.43|
70870967|NCT03000439|141226959|OTHER||Difference in percentage|-23.39|||||TWO_SIDED|95.0|-47.19|0.42|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 8||0.42|-47.19|
71145137|NCT03186209|141783900|SUPERIORITY||Mean Difference (Final Values)|-119.31|||<|0.0001|TWO_SIDED|95.0|-169.78|-68.84||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|model includes treatment , baseline eosinophil count, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||-68.84|-169.78|<0.0001
71145138|NCT03186209|141783901|SUPERIORITY||Rate Ratio|0.83||||0.4519|TWO_SIDED|95.0|0.51|1.35||Nominal p-value. Not multiplicity protected by testing procedure.|Negative binomial|Model with covariates: treatment group, region (China/Non-China), number of exacerbations in previous year, use of maintenance oral corticosteroids||||1.35|0.51|0.4519
71145139|NCT03186209|141783902|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.0214|TWO_SIDED|95.0|0.02|0.22||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline pre-bronchodilator FEV1, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||0.22|0.02|0.0214
70870968|NCT03000439|141226959|OTHER||Difference in percentage|-0.12|||||TWO_SIDED|95.0|-23.99|23.76|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 12||23.76|-23.99|
70870969|NCT03000439|141226959|OTHER||Difference in percentage|6.68|||||TWO_SIDED|95.0|-17.2|30.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 16||30.56|-17.20|
70870970|NCT03000439|141226959|OTHER||Difference in percentage|13.13|||||TWO_SIDED|95.0|-9.92|36.19|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 20||36.19|-9.92|
70870971|NCT03000439|141226959|OTHER||Difference in percentage|0.23|||||TWO_SIDED|95.0|-24.24|24.7|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 24||24.70|-24.24|
70870972|NCT03000439|141226959|OTHER||Difference in percentage|3.46|||||TWO_SIDED|95.0|-20.75|27.66|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 28||27.66|-20.75|
70870973|NCT03000439|141226959|OTHER||Difference in percentage|5.99|||||TWO_SIDED|95.0|-16.29|28.28|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 32||28.28|-16.29|
71145140|NCT03186209|141783903|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.1589|TWO_SIDED|95.0|-0.51|0.08||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline total asthma symptom score, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||0.08|-0.51|0.1589
71145141|NCT02559622|141783909|SUPERIORITY||Least Square (LS) mean difference|1.17||||0.223|TWO_SIDED|95.0|-0.72|3.06|||ANCOVA|||||3.06|-0.72|0.2230
71145142|NCT02163538|141783927|SUPERIORITY|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||||||0.0001
71145143|NCT02163538|141783928|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.00
71145144|NCT02163538|141783929|SUPERIORITY|||||||0.582|||||||Chi-squared|||||||0.582
71145145|NCT02163538|141783930|SUPERIORITY|||||||0.0031|||||||Chi-squared|||||||0.0031
71145146|NCT02163538|141783931|SUPERIORITY|||||||0.0281|||||||Wilcoxon (Mann-Whitney)|||||||0.0281
71145147|NCT02163538|141783932|SUPERIORITY|||||||0.0821|||||||Wilcoxon (Mann-Whitney)|||||||.0821
71145148|NCT00627393|141783954|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.73|TWO_SIDED|95.0|0.44|3.2|||Regression, Logistic|Ordinary multiple logistic regression including treatment arm, infection strata, underlying disease, zubrod score, respiratory symptoms, and age.|Control group is the reference group. Model adjusted for infection strata, underlying disease, zubrod score, respiratory symptoms, and age.|||3.20|0.44|0.73
71145149|NCT00627393|141783957|SUPERIORITY_OR_OTHER||Log Rank P-Value|0.43||||0.43|TWO_SIDED|||||Competing risks analysis for time to GVHD for subjects with allogeneic HST. The sample size was very small (n=7 in the granulocyte group, and n=8 in the control group).|Competing Risks|||||||0.43
71145150|NCT00627393|141783962|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.293|STANDARD_ERROR_OF_MEAN|0.25885||0.35|TWO_SIDED|95.0|0.778|2.147|||Log Rank|Log-rank test to compare survival distributions between the control group and treatment group.|The control group is considered the reference group.|||2.147|0.778|0.35
71145151|NCT02761330|141784015|OTHER|||||||0.016||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the recovery rate of Psychomotor Vigilance Task (PVT) reaction time.||||0.016
71145152|NCT02761330|141784015|OTHER|||||||0.012||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Psychomotor Vigilance Task (PVT) reaction time.||||0.012
71145153|NCT02761330|141784015|OTHER|||||||0.031||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the recovery rate of Digital Symbol Substitution Task (DSST) reaction time.||||0.031
71145154|NCT02761330|141784015|OTHER|||||||0.203||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Digital Symbol Substitution Task (DSST) reaction time.||||0.203
71145155|NCT02761330|141784015|OTHER|||||||0.008||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the recovery rate of Motor Praxis Task (MP) reaction time.||||0.008
71145156|NCT02761330|141784015|OTHER|||||||0.496||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Motor Praxis Task (MP) reaction time.||||0.496
71145157|NCT02761330|141784015|OTHER|||||||0.844||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the recovery rate of Visual Object Learning Task (VOLT) reaction time.||||0.844
71145158|NCT02761330|141784015|OTHER|||||||0.016||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Visual Object Learning Task (VOLT) reaction time.||||0.016
71145159|NCT02761330|141784015|OTHER|||||||0.062||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the recovery rate of Abstract Matching task (AM) reaction time.||||0.062
71145160|NCT02761330|141784015|OTHER|||||||0.039||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Abstract Matching task (AM) reaction time.||||0.039
71145161|NCT02761330|141784016|OTHER|||||||0.016||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the initial decrement of Psychomotor Vigilance Task (PVT) reaction time.||||0.016
70953040|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.04||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in cF-cM connectivity induced by active versus sham rTMS.||||0.04
70870974|NCT03000439|141226959|OTHER||Difference in percentage|3.8|||||TWO_SIDED|95.0|-20.92|28.52|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 36||28.52|-20.92|
70953041|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.05||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cF-iM connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.05
70870975|NCT03000439|141226959|OTHER||Difference in percentage|10.25|||||TWO_SIDED|95.0|-13.88|34.39|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 40||34.39|-13.88|
70870976|NCT03000439|141226959|OTHER||Difference in percentage|20.62|||||TWO_SIDED|95.0|-3.43|44.67|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 44||44.67|-3.43|
70870977|NCT03000439|141226959|OTHER||Difference in percentage|20.62|||||TWO_SIDED|95.0|-3.43|44.67|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 48||44.67|-3.43|
70953042|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.59||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cF-iM connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.59
70870978|NCT03000439|141226959|OTHER||Difference in percentage|17.4|||||TWO_SIDED|95.0|-7.03|41.82|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 52||41.82|-7.03|
70870979|NCT03000439|141226960|OTHER||Difference in percentage|-26.61|||||TWO_SIDED|95.0|-50.42|-2.81|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 4||-2.81|-50.42|
70870980|NCT03000439|141226960|OTHER||Difference in percentage|-20.16|||||TWO_SIDED|95.0|-43.91|3.59|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 8||3.59|-43.91|
70870981|NCT03000439|141226960|OTHER||Difference in percentage|-9.79|||||TWO_SIDED|95.0|-34.31|14.72|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 12||14.72|-34.31|
70870982|NCT03000439|141226960|OTHER||Difference in percentage|0.23|||||TWO_SIDED|95.0|-24.24|24.7|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 16||24.70|-24.24|
70870983|NCT03000439|141226960|OTHER||Difference in percentage|10.25|||||TWO_SIDED|95.0|-13.88|34.39|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 20||34.39|-13.88|
70870984|NCT03000439|141226960|OTHER||Difference in percentage|-3.0|||||TWO_SIDED|95.0|-27.67|21.68|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 24||21.68|-27.67|
70870985|NCT03000439|141226960|OTHER||Difference in percentage|-3.0|||||TWO_SIDED|95.0|-27.67|21.68|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 28||21.68|-27.67|
70870986|NCT03000439|141226960|OTHER||Difference in percentage|-6.91|||||TWO_SIDED|95.0|-30.65|16.83|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 32||16.83|-30.65|
70870987|NCT03000439|141226960|OTHER||Difference in percentage|3.8|||||TWO_SIDED|95.0|-20.92|28.52|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 36||28.52|-20.92|
70953043|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.12||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in cF-iM connectivity induced by active versus sham rTMS.||||0.12
70953044|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.1||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iM-iT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.10
70953045|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.57||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iM-iT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.57
70953046|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.06||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iM-iT connectivity induced by active versus sham rTMS.||||0.06
70953047|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.12||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cM-cT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.12
70953048|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.69||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cM-cT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.69
70953049|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.14||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in cM-cT connectivity induced by active versus sham rTMS.||||0.14
70953050|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.12||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iM-cM connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.12
70953051|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.6||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iM-cM connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.60
70953052|NCT04325282|141407570|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.04||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iM-cM connectivity induced by active versus sham rTMS.||||0.04
70953053|NCT00527787|141407573|SUPERIORITY_OR_OTHER||proportions|4.1||||0.001|TWO_SIDED|95.0|1.9|7.7|||Cochran-Mantel-Haenszel|CMH test stratified by use of low-dose aspirin (Yes/No) at randomization.||The primary efficacy endpoint was the proportion of subjetcs developing gastric ulcers throughout 6 months of study treatment. A summary, including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of gastric ulcers at 6 months. The cumulative proportion of subjects developing gastric ulcers at 6 months was analyzed using the CMH test stratified by use of low-dose aspirin (Yes/No) at randomization.||7.7|1.9|0.001
70953054|NCT00527787|141407574|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
70953055|NCT00527787|141407575|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
70953056|NCT00527787|141407576|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Cochran-Mantel-Haenszel|||||||0.003
70953057|NCT00527787|141407577|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
70953058|NCT02783027|141407623|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|Two sample t-test on the change in sleep quality from baseline to 4 months.||||||0.76
70953059|NCT02783027|141407624|SUPERIORITY||||||<|0.0001||||||Test for group\*time interaction.|Mixed Models Analysis|||||||<0.0001
70953060|NCT02783027|141407625|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Test for group\*time interaction.||||||<0.0001
70953061|NCT02783027|141407626|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Test for group\*time interaction.||||||<0.0001
70870988|NCT03000439|141226960|OTHER||Difference in percentage|7.03|||||TWO_SIDED|95.0|-17.43|31.48|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 40||31.48|-17.43|
70870989|NCT03000439|141226960|OTHER||Difference in percentage|17.74|||||TWO_SIDED|95.0|-7.03|42.52|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 44||42.52|-7.03|
70870990|NCT03000439|141226960|OTHER||Difference in percentage|14.52|||||TWO_SIDED|95.0|-10.52|39.55|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 48||39.55|-10.52|
70870991|NCT03000439|141226960|OTHER||Difference in percentage|17.74|||||TWO_SIDED|95.0|-7.03|42.52|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 52||42.52|-7.03|
70870992|NCT03000439|141226961|OTHER||Difference in percentage|-15.09|||||TWO_SIDED|95.0|-34.29|4.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 4||4.10|-34.29|
70870993|NCT03000439|141226961|OTHER||Difference in percentage|-12.21|||||TWO_SIDED|95.0|-29.08|4.65|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 8||4.65|-29.08|
70870994|NCT03000439|141226961|OTHER||Difference in percentage|-8.99|||||TWO_SIDED|95.0|-25.07|7.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 12||7.10|-25.07|
70870995|NCT03000439|141226961|OTHER||Difference in percentage|4.61|||||TWO_SIDED|95.0|-12.01|21.23|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 16||21.23|-12.01|
70870996|NCT03000439|141226961|OTHER||Difference in percentage|4.61|||||TWO_SIDED|95.0|-12.01|21.23|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 20||21.23|-12.01|
70870997|NCT03000439|141226961|OTHER||Difference in percentage|-8.99|||||TWO_SIDED|95.0|-25.07|7.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 24||7.10|-25.07|
70870998|NCT03000439|141226961|OTHER||Difference in percentage|-11.87|||||TWO_SIDED|95.0|-30.52|6.79|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 28||6.79|-30.52|
70870999|NCT03000439|141226961|OTHER||Difference in percentage|-5.07|||||TWO_SIDED|95.0|-24.08|13.94|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 32||13.94|-24.08|
70871000|NCT03000439|141226961|OTHER||Difference in percentage|-5.41|||||TWO_SIDED|95.0|-22.7|11.87|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 36||11.87|-22.70|
70871001|NCT03000439|141226961|OTHER||Difference in percentage|-11.52|||||TWO_SIDED|95.0|-31.65|8.61|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 40||8.61|-31.65|
70953062|NCT02783027|141407627|SUPERIORITY|||||||0.91|||||||t-test, 2 sided|Two sample t-test for change in Occupational Fatigue Exhaustion Recovery (OFER) inter-shift recovery between groups||||||0.91
70953063|NCT03898167|141407629|OTHER||Relative Participation|2.36|||||TWO_SIDED|95.0|1.99|2.8||95% CIs were calculated.||||Bivariable tables, Pearson chi-square and Kruskal-Wallis nonparametric tests were used to compare demographic/health care characteristics by study group. Log binomial regression was used to calculate screening proportion, participation difference, and relative participation (calculated as relative risk), with 95% CIs. Overall participation difference and relative participation for SC and SC with patient navigation vs TR were calculated by combining numerators and denominators from each group.||2.80|1.99|
70871002|NCT03000439|141226961|OTHER||Difference in percentage|-1.84|||||TWO_SIDED|95.0|-20.16|16.48|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 44||16.48|-20.16|
70871003|NCT03000439|141226961|OTHER||Difference in percentage|-8.64|||||TWO_SIDED|95.0|-26.66|9.38|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 48||9.38|-26.66|
70871004|NCT03000439|141226961|OTHER||Difference in percentage|-5.07|||||TWO_SIDED|95.0|-24.08|13.94|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 52||13.94|-24.08|
70871005|NCT03000439|141226962|OTHER||Difference in percentage|-12.21|||||TWO_SIDED|95.0|-29.08|4.65|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 4||4.65|-29.08|
70871006|NCT03000439|141226962|OTHER||Difference in percentage|-14.75|||||TWO_SIDED|95.0|-35.32|5.83|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 8||5.83|-35.32|
70871007|NCT03000439|141226962|OTHER||Difference in percentage|-8.29|||||TWO_SIDED|95.0|-27.91|11.32|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 12||11.32|-27.91|
70871008|NCT03000439|141226962|OTHER||Difference in percentage|1.73|||||TWO_SIDED|95.0|-17.48|20.93|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 16||20.93|-17.48|
70871009|NCT03000439|141226962|OTHER||Difference in percentage|1.38|||||TWO_SIDED|95.0|-16.15|18.91|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 20||18.91|-16.15|
70871010|NCT03000439|141226962|OTHER||Difference in percentage|-5.41|||||TWO_SIDED|95.0|-22.7|11.87|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 24||11.87|-22.70|
70871011|NCT03000439|141226962|OTHER||Difference in percentage|-11.87|||||TWO_SIDED|95.0|-30.52|6.79|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 28||6.79|-30.52|
70953064|NCT05177354|141407632|SUPERIORITY||Proportion|89.3|||<|0.001|ONE_SIDED|97.5|71.8|||"It is hypothesized that the proportion of low-back and leg pain subjects with a reduction in overstimulation sensation during Closed Loop On compared to Closed Loop Off period exceeds a performance goal of 50%.~H0: p ≤ 50% HA: p \> 50%"|Binomial Exact Test||||||71.8|<0.001
70871012|NCT03000439|141226962|OTHER||Difference in percentage|-5.07|||||TWO_SIDED|95.0|-24.08|13.94|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 32||13.94|-24.08|
70871013|NCT03000439|141226962|OTHER||Difference in percentage|-8.64|||||TWO_SIDED|95.0|-26.66|9.38|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 36||9.38|-26.66|
70871014|NCT03000439|141226962|OTHER||Difference in percentage|-11.52|||||TWO_SIDED|95.0|-31.65|8.61|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 40||8.61|-31.65|
70871015|NCT03000439|141226962|OTHER||Difference in percentage|-8.29|||||TWO_SIDED|95.0|-27.91|11.32|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 44||11.32|-27.91|
70871016|NCT03000439|141226962|OTHER||Difference in percentage|-8.29|||||TWO_SIDED|95.0|-27.91|11.32|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 48||11.32|-27.91|
70871017|NCT03000439|141226962|OTHER||Difference in percentage|-5.07|||||TWO_SIDED|95.0|-24.08|13.94|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 52||13.94|-24.08|
70871018|NCT03000439|141226965|OTHER||Difference in percentage|-8.99|||||TWO_SIDED|95.0|-25.07|7.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 4||7.10|-25.07|
70871019|NCT03000439|141226965|OTHER||Difference in percentage|-19.01|||||TWO_SIDED|95.0|-35.25|-2.76|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 8||-2.76|-35.25|
70871020|NCT03000439|141226965|OTHER||Difference in percentage|-15.44|||||TWO_SIDED|95.0|-32.98|2.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 12||2.10|-32.98|
70871021|NCT03000439|141226965|OTHER||Difference in percentage|-12.56|||||TWO_SIDED|95.0|-27.22|2.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 16||2.10|-27.22|
70953065|NCT03548220|141407641|SUPERIORITY||||||<|0.0001||||||2-sided p-value|Exact Cochran-Mantel-Haenszel|||||||<0.0001
70953066|NCT03548220|141407642|SUPERIORITY||LS Mean Difference|18.21|||<|0.0001|TWO_SIDED|95.0|12.41|24.01|||Mixed-effect Model Repeated Measure||Standard error = 2.913|||24.01|12.41|<0.0001
70871022|NCT03000439|141226965|OTHER||Difference in percentage|-8.99|||||TWO_SIDED|95.0|-25.07|7.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 20||7.10|-25.07|
70871023|NCT03000439|141226965|OTHER||Difference in percentage|-12.21|||||TWO_SIDED|95.0|-29.08|4.65|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 24||4.65|-29.08|
70871024|NCT03000439|141226965|OTHER||Difference in percentage|-8.64|||||TWO_SIDED|95.0|-26.66|9.38|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 28||9.38|-26.66|
70871025|NCT03000439|141226965|OTHER||Difference in percentage|-8.64|||||TWO_SIDED|95.0|-26.66|9.38|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 32||9.38|-26.66|
70871026|NCT03000439|141226965|OTHER||Difference in percentage|-1.84|||||TWO_SIDED|95.0|-20.16|16.48|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 36||16.48|-20.16|
70871027|NCT03000439|141226965|OTHER||Difference in percentage|-4.72|||||TWO_SIDED|95.0|-25.17|15.72|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 40||15.72|-25.17|
70871028|NCT03000439|141226965|OTHER||Difference in percentage|-8.29|||||TWO_SIDED|95.0|-27.91|11.32|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 44||11.32|-27.91|
70871029|NCT03000439|141226965|OTHER||Difference in percentage|-4.72|||||TWO_SIDED|95.0|-25.17|15.72|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 48||15.72|-25.17|
70871030|NCT03000439|141226965|OTHER||Difference in percentage|2.07|||||TWO_SIDED|95.0|-18.53|22.68|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 52||22.68|-18.53|
70871031|NCT03292588|141226971|SUPERIORITY|Negative binomial model for the rate of exacerbations in the first year. The model included an offset term to account for differential follow-up among participants. To account for adaptive randomization, the model was also adjusted for study site, number of exacerbations in year prior to study (2 or 3+), peripheral blood eosinophils (\< or ≥400 cells/μl), BMI (\< or ≥95th percentile for age), total serum IgE (\< or ≥540 kUA/L) and treatment dose (40 mg or 100 mg).|Risk Ratio (RR)|0.73||||0.027|TWO_SIDED|95.0|0.56|0.96|||Regression, Negative Binomial|Adjusted relative rate of exacerbations in the first year.||||0.96|0.56|0.027
70871032|NCT03292588|141226972|SUPERIORITY||Least Square Mean Difference|-0.28||||0.29|TWO_SIDED|95.0|-0.81|0.24|||Mixed Models Analysis|The difference in least square mean of CASI scores for week 12.||Week 12||0.24|-0.81|0.290
70871033|NCT03292588|141226972|SUPERIORITY||Least Square Mean Difference|-0.07||||0.82|TWO_SIDED|95.0|-0.69|0.55|||Mixed Models Analysis|The difference in least square mean of CASI scores for week 24.||Week 24||0.55|-0.69|0.820
70871034|NCT03292588|141226972|SUPERIORITY||Least Square Mean Difference|-0.51||||0.096|TWO_SIDED|95.0|-1.11|0.09|||Mixed Models Analysis|The difference in least square mean of CASI scores for week 36.||Week 36||0.09|-1.11|0.096
70953067|NCT03548220|141407645|SUPERIORITY||LS Mean Difference|-26.26|||<|0.0001|TWO_SIDED|95.0|-37.82|-14.7|||Mixed-effect Model Repeated Measure||Standard error = 5.788|||-14.70|-37.82|<0.0001
70953068|NCT03548220|141407646|SUPERIORITY||LS Mean Difference|-70.81||||0.0027|TWO_SIDED|95.0|-115.88|-25.74|||Mixed-effect Model Repeated Measure||Standard error = 22.488|||-25.74|-115.88|0.0027
70953069|NCT03548220|141407647|SUPERIORITY||LS Mean Difference|0.158||||0.0079|TWO_SIDED|95.0|0.043|0.273|||Mixed-effect Model Repeated Measure||Standard error = 0.0578|||0.273|0.043|0.0079
70953070|NCT03548220|141407648|SUPERIORITY||LS Mean Difference|-0.1011|||<|0.0001|TWO_SIDED|95.0|-0.1391|-0.0632|||Mixed-effect Model Repeated Measure||Standard error = 0.01904|||-0.0632|-0.1391|<0.0001
70953071|NCT03548220|141407649|SUPERIORITY||LS Mean Difference|-3.11||||0.0247|TWO_SIDED|95.0|-5.8|-0.41|||Mixed-effect Model Repeated Measure||Standard error = 1.352|||-0.41|-5.80|0.0247
70953072|NCT03548220|141407650|SUPERIORITY||LS Mean Difference|-3.25||||0.0421|TWO_SIDED|95.0|-6.39|-0.12|||Mixed-effect Model Repeated Measure||Standard error = 1.574|||-0.12|-6.39|0.0421
70953073|NCT01253135|141407760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_DEVIATION|4.7||0.3393|TWO_SIDED|95.0|-3.08|0.84|||Prentice-Wilcoxon test||The Confidence Interval was based on a t-distribution|||0.84|-3.08|.3393
70953074|NCT01253135|141407761|SUPERIORITY_OR_OTHER|||||||0.4771|TWO_SIDED||||||Log Rank|Testing was by a Log Rank test with significance being at P \< 0.05||||||.4771
70953075|NCT00379288|141407798|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with TEAEs|77.4||||||95.0||||||||||||
70953076|NCT00379288|141407798|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with related AEs|28.4||||||95.0||||||||||||
70953077|NCT00379288|141407798|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with severe AEs|5.7||||||95.0||||||||||||
70953078|NCT00379288|141407798|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with serious AEs|4.9||||||95.0||||||||||||
71145162|NCT02761330|141784016|OTHER|||||||0.039||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Psychomotor Vigilance Task (PVT) reaction time.||||0.039
70953079|NCT00379288|141407798|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with TEAEs|79.2||||||95.0||||||||||||
70953080|NCT00379288|141407798|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with related AEs|23.1||||||95.0||||||||||||
70953081|NCT00379288|141407798|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with severe AEs|3.8||||||95.0||||||||||||
70953082|NCT00379288|141407798|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with serious AEs|6.1||||||95.0||||||||||||
70953083|NCT00379288|141407798|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with TEAEs|82.4||||||95.0||||||||||||
70953084|NCT00379288|141407798|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with related AEs|23.5||||||95.0||||||||||||
70953085|NCT00379288|141407798|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with severe AEs|5.9||||||95.0||||||||||||
70953086|NCT00379288|141407798|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with serious AEs|5.8||||||95.0||||||||||||
70953087|NCT00379288|141407798|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with TEAEs|76.9||||||95.0||||||||||||
70953088|NCT00379288|141407798|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with related AEs|20.0||||||95.0||||||||||||
70953089|NCT00379288|141407798|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with severe AEs|6.2||||||95.0||||||||||||
70953090|NCT00379288|141407798|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with serious AEs|3.1||||||95.0||||||||||||
70953091|NCT00918879|141407799|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.46|STANDARD_ERROR_OF_MEAN|0.139||0.0011||95.0|-0.73|-0.18|||ANCOVA|\* adjusted for baseline HbA1c||||-0.18|-0.73|0.0011
70953092|NCT00918879|141407800|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.19|STANDARD_ERROR_OF_MEAN|5.438||0.0623||95.0|-20.91|0.53|||ANCOVA|\* Adjusted for baseline FPG||||0.53|-20.91|0.0623
70953093|NCT00918879|141407801|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|0.302||0.0623||95.0|-1.17|0.02|||ANCOVA|\* Adjusted for baseline FPG||||0.02|-1.17|0.0623
70953094|NCT00918879|141407802|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.8||||||95.0|-1.7|19.3|||Fisher Exact|||||19.3|-1.7|
70953095|NCT05602727|141407821|SUPERIORITY|Difference in LS Means (MK-1942 - Placebo)|LS Mean Difference|2.1||||0.186|TWO_SIDED|97.5|-1.6|5.8|||Longitudinal ANCOVA|||||5.8|-1.6|0.186
70953096|NCT05602727|141407821|SUPERIORITY|Difference in LS Means (MK-1942 - Placebo)|LS Mean Difference|-1.4||||0.4|TWO_SIDED|97.5|-5.2|2.4|||Longitudinal ANCOVA|||||2.4|-5.2|0.400
70953097|NCT05602727|141407825|SUPERIORITY|Difference in LS Means|LS Mean Difference|-2.9||||0.196|TWO_SIDED|97.5|-8.0|2.2|||Longitudinal ANCOVA|||||2.2|-8.0|0.196
70953098|NCT05602727|141407825|SUPERIORITY|Difference in LS Means|LS Mean Difference|-4.2||||0.081|TWO_SIDED|97.5|-9.6|1.3|||Longitudinal ANCOVA|||||1.3|-9.6|0.081
70953099|NCT04020185|141407853|OTHER||maximum tolerated dose (monotherapy)|1200.0|||||TWO_SIDED|||||||||||||
70953100|NCT03433677|141407860|SUPERIORITY||Median Difference (Final Values)|0.0||||0.375|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon signed-rank test|||||0.00|0.00|0.375
70953101|NCT03433677|141407861|SUPERIORITY|||||||0.468|||||||Prescott's Exact test|||||||0.468
70953102|NCT03433677|141407862|SUPERIORITY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
70953103|NCT03433677|141407863|SUPERIORITY||LSMean Difference|-1.8||||0.304|TWO_SIDED|95.0|-5.3|1.7|||Mixed Models Analysis|||||1.7|-5.3|0.304
70953104|NCT03433677|141407864|SUPERIORITY||LSMean Difference|-2.4||||0.057|TWO_SIDED|95.0|-4.8|0.1|||Mixed Models Analysis|||||0.1|-4.8|0.057
70953105|NCT03433677|141407865|SUPERIORITY||LSMeans|0.11||||0.177|TWO_SIDED|95.0|-0.05|0.27|||Mixed Models Analysis||LSMean Difference|||0.27|-0.05|0.177
70953106|NCT03733314|141407953|SUPERIORITY||Difference|10.3|||||TWO_SIDED|95.0|-24.9|45.4|||||The difference of percentage was calculated as E6011 minus placebo.|||45.4|-24.9|
70953107|NCT03733314|141407958|SUPERIORITY||Difference|-7.1|||||TWO_SIDED|95.0|-32.1|18.0|||||The difference of percentage was calculated as E6011 minus placebo.|||18.0|-32.1|
70953108|NCT03733314|141407959|SUPERIORITY||Difference|8.3|||||TWO_SIDED|95.0|-7.3|24.0|||||The difference of percentage was calculated as E6011 minus placebo.|||24.0|-7.3|
70953109|NCT01240915|141407970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.223||0.96|TWO_SIDED|80.0|0.12|0.69||1-sided p-value|ANCOVA|||Pooled MultiStem versus Pooled Placebo||0.69|0.12|0.96
70953110|NCT01240915|141407971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.161||0.54|TWO_SIDED|80.0|-0.19|0.22||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 8||Pooled MultiStem versus Pooled Placebo (Week 4)||0.22|-0.19|0.54
70953111|NCT01240915|141407972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.174||0.67|TWO_SIDED|80.0|-0.15|0.3||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 8||Pooled MultiStem versus Pooled Placebo (Week 8)||0.30|-0.15|0.67
71145163|NCT02761330|141784016|OTHER|||||||0.031||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the initial decrement of Digital Symbol Substitution Task (DSST) reaction time.||||0.031
70953112|NCT01240915|141407979|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.02||||0.53|TWO_SIDED|80.0|0.73|1.42||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 4)||1.42|0.73|0.53
70871035|NCT03292588|141226972|SUPERIORITY||Least Square Mean Difference|-0.06||||0.831|TWO_SIDED|95.0|-0.65|0.52|||Mixed Models Analysis|The difference in least square mean of CASI scores for week 48.||Week 48||0.52|-0.65|0.831
70871036|NCT03292588|141226972|SUPERIORITY||Least Square Mean Difference|0.02||||0.947|TWO_SIDED|95.0|-0.6|0.64|||Mixed Models Analysis|The difference in least square mean of CASI scores for week 52.||Week 52||0.64|-0.60|0.947
70871037|NCT03292588|141226973|SUPERIORITY|A generalized logit model was used to analyze Physician Global Assessment Tool at Visit 14. The model included treatment arm as fixed effect as primary exposure but was also adjusted for study site, # of exacerbations in year prior to study (2 or 3+), peripheral blood eosinophils ((\< or ≥400 cells/μl), BMI (\< or ≥95th percentile for age) \& total serum IgE (\< or ≥540 kUA/L). No imputation of missing data was used for participants who weren't assessed for quality of life measurements at Visit 14.|Odds Ratio (OR)|1.01||||0.974|TWO_SIDED|95.0|0.62|1.64|||Regression, Logistic|||Physician Global Assessment Tool||1.64|0.62|0.974
70871038|NCT03292588|141226974|SUPERIORITY|A generalized logit model was used to analyze the Patient Global Assessment Tool at Visit 14. The model included treatment arm as fixed effect as the primary exposure but was adjusted for study site, # of exacerbations in year prior to study (2 or 3+), peripheral blood eosinophils ((\< or ≥400 cells/μl), BMI (\< or ≥95th percentile for age) \& total serum IgE (\< or ≥540 kUA/L). No imputation of missing data was used for participants who weren't assessed for quality of life measurements at Visit 14.|Odds Ratio (OR)|0.72||||0.238|TWO_SIDED|95.0|0.42|1.24|||Regression, Logistic|||Patient Global Assessment Tool||1.24|0.42|0.238
70871039|NCT03292588|141226975|SUPERIORITY|A generalized mixed model as described in section 8.3.1 was used to analyze each spirometry and impulse oscillometry parameter, separately, at each visit where the lung function was collected.|Least Square Mean Difference|-0.005||||0.591|TWO_SIDED|95.0|-0.023|0.013|||Mixed Models Analysis|||FEV1/FVC Week 12||0.013|-0.023|0.591
70871040|NCT03292588|141226975|SUPERIORITY||Least Square Mean Difference|-0.011||||0.265|TWO_SIDED|95.0|-0.031|0.008|||Mixed Models Analysis|||FEV1/FVC Week 24||0.008|-0.031|0.265
70871041|NCT03292588|141226975|SUPERIORITY||Least Square Mean Difference|0.011||||0.345|TWO_SIDED|95.0|-0.012|0.033|||Mixed Models Analysis|||FEV1/FVC Week 36||0.033|-0.012|0.345
70871042|NCT03292588|141226975|SUPERIORITY||Least Square Mean Difference|0.013||||0.248|TWO_SIDED|95.0|-0.009|0.036|||Mixed Models Analysis|||FEV1/FVC Week 48||0.036|-0.009|0.248
70871043|NCT03292588|141226975|SUPERIORITY||Least Square Mean Difference|-0.002||||0.864|TWO_SIDED|95.0|-0.023|0.02|||Mixed Models Analysis|||FEV1/FVC Week 52||0.020|-0.023|0.864
70871044|NCT03292588|141226976|SUPERIORITY||Least Square Mean Difference|-0.4||||0.816|TWO_SIDED|95.0|-3.8|3.0|||Mixed Models Analysis|||FEV1PP Week 12||3.0|-3.8|0.816
70871045|NCT03292588|141226976|SUPERIORITY||Least Square Mean Difference|-3.4||||0.095|TWO_SIDED|95.0|-7.4|0.6|||Mixed Models Analysis|||FEV1PP Week 24||0.6|-7.4|0.095
70871046|NCT03292588|141226976|SUPERIORITY||Least Square Mean Difference|1.5||||0.444|TWO_SIDED|95.0|-2.4|5.5|||Mixed Models Analysis|||FEV1PP Week 36||5.5|-2.4|0.444
70871047|NCT03292588|141226976|SUPERIORITY||Least Square Mean Difference|0.6||||0.751|TWO_SIDED|95.0|-3.3|4.6|||Mixed Models Analysis|||FEV1PP Week 48||4.6|-3.3|0.751
70871048|NCT03292588|141226976|SUPERIORITY||Least Square Mean Difference|-2.6||||0.184|TWO_SIDED|95.0|-6.5|1.3|||Mixed Models Analysis|||FEV1PP Week 52||1.3|-6.5|0.184
70871049|NCT03292588|141226977|SUPERIORITY|Negative binomial model for the rate of exacerbations (per year. The model included an offset term to account for differential follow-up among participants. To account for adaptive randomization, the model was also adjusted for study site, number of exacerbations in year prior to study (2 or 3+), peripheral blood eosinophils (\< or ≥400 cells/μl), BMI (\< or ≥95th percentile for age), total serum IgE (\< or ≥540 kUA/L) and treatment dose (40 mg or 100 mg).|Risk Ratio (RR)|0.85||||0.458|TWO_SIDED|95.0|0.55|1.31|||Mixed Models Analysis|||Did not meet FDA-approved dosing||1.31|0.55|0.458
70871050|NCT03292588|141226978|SUPERIORITY|Negative binomial model for the rate of exacerbations (per year. The model included an offset term to account for differential follow-up among participants. To account for adaptive randomization, the model was also adjusted for study site, number of exacerbations in year prior to study (2 or 3+), peripheral blood eosinophils (\< or ≥400 cells/μl), BMI (\< or ≥95th percentile for age), total serum IgE (\< or ≥540 kUA/L) and treatment dose (40 mg or 100 mg).|Risk Ratio (RR)|0.67||||0.025|TWO_SIDED|95.0|0.47|0.95|||Regression, Negative Binomial|||Fit FDA-approved dosing||0.95|0.47|0.025
70871051|NCT03292588|141226979|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.3587|TWO_SIDED|95.0|0.63|1.18|||Regression, Cox|||||1.18|0.63|0.3587
70953113|NCT01240915|141407979|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.48||||0.91|TWO_SIDED|80.0|1.02|2.14||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 8)||2.14|1.02|0.91
70953114|NCT01240915|141407979|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.38||||0.81|TWO_SIDED|80.0|0.86|2.23||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 12)||2.23|0.86|0.81
70953115|NCT01240915|141407979|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.94||||0.44|TWO_SIDED|80.0|0.59|1.51||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 12)||1.51|0.59|0.44
70953116|NCT01240915|141407979|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.18||||0.67|TWO_SIDED|80.0|0.72|1.94||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 12)||1.94|0.72|0.67
70953117|NCT01240915|141407979|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.12||||0.62|TWO_SIDED|80.0|0.68|1.84||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 16)||1.84|0.68|0.62
70953118|NCT01240915|141407979|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.95||||0.95|TWO_SIDED|80.0|0.58|1.57||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 16)||1.57|0.58|0.95
70953119|NCT01240915|141407979|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.81||||0.3|TWO_SIDED|80.0|0.49|1.36||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 16)||1.36|0.49|0.30
70953120|NCT01240915|141407980|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.17||||0.79|TWO_SIDED|80.0|0.91|1.51||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 4)||1.51|0.91|0.79
70953121|NCT01240915|141407980|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.21||||0.8|TWO_SIDED|80.0|0.9|1.63||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 8)||1.63|0.90|0.80
70953122|NCT01240915|141407980|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|2.75||||0.99|TWO_SIDED|80.0|1.63|4.64||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 12)||4.64|1.63|0.99
70953123|NCT01240915|141407980|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.96||||0.96|TWO_SIDED|80.0|1.19|3.25||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 12)||3.25|1.19|0.96
70953124|NCT01240915|141407980|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.98||||0.95|TWO_SIDED|80.0|1.15|3.41||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 12)||3.41|1.15|0.95
70953125|NCT01240915|141407980|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|2.3||||0.99|TWO_SIDED|80.0|1.52|3.48||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 16)||3.48|1.52|0.99
70953126|NCT01240915|141407980|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.1||||0.62|TWO_SIDED|80.0|0.74|1.63||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 16)||1.63|0.74|0.62
70953127|NCT01240915|141407980|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.51||||0.89|TWO_SIDED|80.0|0.98|2.32||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 16)||2.32|0.98|0.89
70953128|NCT01240915|141407981|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.34|TWO_SIDED|80.0|0.66|2.19||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo (Week 4)||2.19|0.66|0.34
70953129|NCT01240915|141407981|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.33|TWO_SIDED|80.0|0.68|2.23||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo (Week 8)||2.23|0.68|0.33
70953130|NCT01240915|141407981|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.37||||0.1|TWO_SIDED|80.0|0.99|5.67||1-sided p-value|Regression, Logistic|||Cohort 3 MM versus Cohort 3 PP (Week 12)||5.67|0.99|0.10
70953131|NCT01240915|141407981|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.74|TWO_SIDED|80.0|0.28|1.55||1-sided p-value|Regression, Logistic|||Cohort 3 MP versus Cohort 3 PP (Week 12)||1.55|0.28|0.74
70953132|NCT01240915|141407981|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.48|TWO_SIDED|80.0|0.41|2.64||1-sided p-value|Regression, Logistic|||Cohort 3 PM versus Cohort 3 PP (Week 12)||2.64|0.41|0.48
70953133|NCT01240915|141407981|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.58|TWO_SIDED|80.0|0.38|2.03||1-sided p-value|Regression, Logistic|||Cohort 3 MM versus Cohort 3 PP (Week 16)||2.03|0.38|0.58
70953134|NCT01240915|141407981|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.68|TWO_SIDED|80.0|0.33|1.66||1-sided p-value|Regression, Logistic|||Cohort 3 MP versus Cohort 3 PP (Week 16)||1.66|0.33|0.68
70953135|NCT01240915|141407981|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.51||||0.84|TWO_SIDED|80.0|0.21|1.23||1-sided p-value|Regression, Logistic|||Cohort 3 PM versus Cohort 3 PP (Week 16)||1.23|0.21|0.84
70953136|NCT01240915|141407982|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.57|TWO_SIDED|80.0|0.22|3.07||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo||3.07|0.22|0.57
70871052|NCT00869349|141226996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.04|TWO_SIDED|95.0|-1.1|0.0||a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Treatment effects are reported as mean between-group differences from baseline to 21 months using t-tests to determine the differential effect of the intervention versus the education group.||0.0|-1.1|0.04
70871053|NCT00869349|141226997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2||||0.01|TWO_SIDED|95.0|-5.6|-0.8||a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Treatment effects are reported as mean between-group differences from baseline to 21 months using t-tests to determine the differential effect of the intervention versus the education group.||-0.8|-5.6|0.01
70871054|NCT00869349|141226998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8||||0.01|TWO_SIDED|95.0|0.5|3.1||a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Treatment effects are reported as mean between-group differences from baseline to 21 months using t-tests to determine the differential effect of the intervention versus the education group.||3.1|0.5|0.01
70953137|NCT01240915|141407983|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.39||||0.85|TWO_SIDED|80.0|0.12|1.23||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo||1.23|0.12|0.85
70953138|NCT01240915|141407984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.27||||0.05|TWO_SIDED|80.0|1.21|4.24||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo (Week 4)||4.24|1.21|0.05
70953139|NCT01240915|141407984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.43|TWO_SIDED|80.0|0.61|1.95||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo (Week 8)||1.95|0.61|0.43
70953140|NCT01240915|141407984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.44|TWO_SIDED|80.0|0.45|2.76||1-sided p-value|Regression, Logistic|||Cohort 3 MM versus Cohort 3 PP (Week 12)||2.76|0.45|0.44
70953141|NCT01240915|141407984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.38|TWO_SIDED|80.0|0.5|3.04||1-sided p-value|Regression, Logistic|||Cohort 3 MP versus Cohort 3 PP (Week 12)||3.04|0.50|0.38
70953142|NCT01240915|141407984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.38||||0.89|TWO_SIDED|80.0|0.14|1.04||1-sided p-value|Regression, Logistic|||Cohort 3 PM versus Cohort 3 PP (Week 12)||1.04|0.14|0.89
70953143|NCT01240915|141407984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.47|TWO_SIDED|80.0|0.45|2.42||1-sided p-value|Regression, Logistic|||Cohort 3 MM versus Cohort 3 PP (Week 16)||2.42|0.45|0.47
71145164|NCT02761330|141784016|OTHER|||||||1||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the initial decrement of Digital Symbol Substitution Task (DSST) reaction time.||||1.0
71145165|NCT02761330|141784016|OTHER|||||||0.195||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the initial decrement of Motor Praxis task (MP) reaction time.||||0.195
70953144|NCT01240915|141407984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.24|TWO_SIDED|80.0|0.7|3.57||1-sided p-value|Regression, Logistic|||Cohort 3 MP versus Cohort 3 PP (Week 16)||3.57|0.70|0.24
70953145|NCT01240915|141407984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53||||0.81|TWO_SIDED|80.0|0.22|1.32||1-sided p-value|Regression, Logistic|||Cohort 3 PM versus Cohort 3 PP (Week 16)||1.32|0.22|0.81
70953146|NCT01240915|141407985|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.84|TWO_SIDED|80.0|0.2|1.24||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo||1.24|0.20|0.84
70953147|NCT01240915|141407986|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3||||0.96|TWO_SIDED|80.0|0.12|0.73||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo||0.73|0.12|0.96
70953148|NCT01240915|141407987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.513||0.87|TWO_SIDED|80.0|-0.08|1.24||1-sided p-value|ANCOVA|||Pooled MultiStem versus Pooled Placebo||1.24|-0.08|0.87
70953149|NCT01240915|141407988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.345||0.8|TWO_SIDED|80.0|-0.15|0.74||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 4)||0.74|-0.15|0.80
70953150|NCT01240915|141407988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.418||0.77|TWO_SIDED|80.0|-0.23|0.84||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 8)||0.84|-0.23|0.77
70953151|NCT01240915|141407988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.666||0.74|TWO_SIDED|80.0|-0.42|1.3||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 12)||1.30|-0.42|0.74
70953152|NCT01240915|141407988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.645||0.88|TWO_SIDED|80.0|-0.08|1.59||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 12)||1.59|-0.08|0.88
70953153|NCT01240915|141407988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.705||0.72|TWO_SIDED|80.0|-0.5|1.33||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 12)||1.33|-0.50|0.72
70953154|NCT01240915|141407988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21|STANDARD_ERROR_OF_MEAN|0.656||0.97|TWO_SIDED|80.0|0.37|2.06||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 16)||2.06|0.37|0.97
70953155|NCT01240915|141407988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.635||0.75|TWO_SIDED|80.0|-0.39|1.25||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 16)||1.25|-0.39|0.75
70953156|NCT01240915|141407988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73|STANDARD_ERROR_OF_MEAN|0.692||0.85|TWO_SIDED|80.0|-0.16|1.63||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 16)||1.63|-0.16|0.85
71145166|NCT02761330|141784016|OTHER|||||||0.57||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the initial decrement of Motor Praxis task (MP) reaction time.||||0.570
71145167|NCT02761330|141784016|OTHER|||||||0.031||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the initial decrement of Visual Object Learning Task (VOLT) reaction time.||||0.031
71145168|NCT02761330|141784016|OTHER|||||||0.016||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the initial decrement of Visual Object Learning Task (VOLT) reaction time.||||0.016
70953157|NCT01240915|141407989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.753||0.75|TWO_SIDED|80.0|-0.46|1.49||1-sided p-value|ANCOVA|||Pooled MultiStem versus Pooled Placebo||1.49|-0.46|0.75
70871055|NCT03633695|141226999|SUPERIORITY||Mean Difference (Final Values)|-0.177|||<|0.0001|TWO_SIDED|95.0|-0.214|-0.14||The threshold for statistical significance was p=0.05.|t-test, 2 sided||Acuity Difference = IC-8 Group - Control Group|The null hypothesis was that the mean acuity for the IC-8 Group was greater (i.e. worse) than or equal to that for the Control Group. The alternative hypothesis was that the mean for the IC-8 Group less (i.e., better) than that for the Control Group.||-0.140|-0.214|<.0001
70953158|NCT01240915|141407990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.144||0.51|TWO_SIDED|80.0|-0.18|0.19||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 4)||0.19|-0.18|0.51
71145169|NCT02761330|141784016|OTHER|||||||1||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the initial decrement of Abstract Matching (AM) task reaction time.||||1.00
71145170|NCT02761330|141784016|OTHER|||||||0.109||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the initial decrement of Abstract Matching (AM) task reaction time.||||0.109
71145171|NCT02761330|141784024|OTHER|||||||0.301|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the delta band at baseline compared to T0 following return of responsiveness.||||0.301
71145172|NCT02761330|141784024|OTHER|||||||0.301|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the delta band at baseline compared to T0 following return of responsiveness.||||0.301
71145173|NCT02761330|141784024|OTHER|||||||0.557|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the delta band at baseline compared to T0 following return of responsiveness.||||0.557
71145174|NCT02761330|141784025|OTHER|||||||0.91|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the theta band at baseline compared to T0 following return of responsiveness.||||0.910
71145175|NCT02761330|141784025|OTHER|||||||0.734|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the theta band at baseline compared to T0 following return of responsiveness.||||0.734
71145176|NCT02761330|141784025|OTHER|||||||0.322|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the theta band at baseline compared to T0 following return of responsiveness.||||0.322
71145177|NCT02761330|141784026|OTHER|||||||0.164|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the alpha band at baseline compared to T0 following return of responsiveness.||||0.164
71145178|NCT02761330|141784026|OTHER|||||||0.039|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the alpha band at baseline compared to T0 following return of responsiveness.||||0.039
71145179|NCT02761330|141784026|OTHER|||||||0.375|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the alpha band at baseline compared to T0 following return of responsiveness.||||0.375
71145180|NCT02761330|141784027|OTHER|||||||0.91|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the beta band at baseline compared to T0 following return of responsiveness.||||0.910
71145181|NCT02761330|141784027|OTHER|||||||0.91|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the beta band at baseline compared to T0 following return of responsiveness.||||0.910
71145182|NCT02761330|141784027|OTHER|||||||0.625|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the beta band at baseline compared to T0 following return of responsiveness.||||0.625
71145183|NCT02761330|141784028|OTHER|||||||0.129|||||||Wilcoxon signed-rank paired test|||Comparison of anterior-posterior functional connectivity (coherence) at baseline compared to T0 following return of responsiveness.||||0.129
71145184|NCT02761330|141784028|OTHER|||||||0.91|||||||Wilcoxon signed-rank paired test|||Comparison of anterior-posterior functional connectivity (coherence) at baseline compared to T0 following return of responsiveness.||||0.910
71145185|NCT02761330|141784028|OTHER|||||||0.625|||||||Wilcoxon signed-rank paired test|||Comparison of anterior-posterior functional connectivity (coherence) at baseline compared to T0 following return of responsiveness.||||0.625
71145186|NCT02761330|141784029|OTHER|||||||1|||||||Wilcoxon signed-rank paired test|||Comparison of anterior-posterior phase-lag (PLI) at baseline compared to T0 following return of responsiveness.||||1.000
71145187|NCT02761330|141784029|OTHER|||||||0.496|||||||Wilcoxon signed-rank paired test|||Comparison of anterior-posterior phase-lag (PLI) at baseline compared to T0 following return of responsiveness.||||0.496
71145188|NCT02761330|141784029|OTHER|||||||0.16|||||||Wilcoxon signed-rank paired test|||Comparison of anterior-posterior phase-lag (PLI) at baseline compared to T0 following return of responsiveness.||||0.160
71145189|NCT02761330|141784030|OTHER|||||||0.008|||||||Wilcoxon Signed-Ranked Test|||Comparison of EEG Entropy using Permutation Entropy (PE) measures at baseline compared to T0 following return of responsiveness.||||0.008
71145190|NCT02761330|141784030|OTHER|||||||0.359|||||||Wilcoxon Signed-Ranked Test|||Comparison of EEG Entropy using Permutation Entropy (PE) measures at baseline compared to T0 following return of responsiveness.||||0.359
71145191|NCT02761330|141784030|OTHER|||||||0.375|||||||Wilcoxon Signed-Ranked Test|||Comparison of EEG Entropy using Permutation Entropy (PE) measures at baseline compared to T0 following return of responsiveness.||||0.375
71145192|NCT00980954|141784049|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.56|TWO_SIDED|90.0|0.65|1.68||One-sided significance level = 0.05.|Log Rank||Reference level = Arm I|Sample size calculations are based on the primary hypothesis that 4 additional cycles of carboplatin and paclitaxel following concurrent radiation and weekly cisplatin will increase 4-year DFS from 80% to 90% for patients with cervical carcinoma with positive nodes and/or positive margins after a radical hysterectomy. One-sided alpha=0.05, statistical power=80%, 5.5 years of accrual with 4 years of follow-up, 2 interim significance tests. 50 DFS events are required to trigger this analysis.||1.68|0.65|0.56
71145193|NCT00980954|141784050|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.4|TWO_SIDED|90.0|0.49|1.69||One-sided significance level = 0.05.|Log Rank|||The 4-year overall survival rate for the control arm is expected to be approximately 85%. The overall survival will be compared between the two arms. The final targeted sample size of 235 patients with the longer accrual time, will provide 64% and 78% power to detect an increase in overall survival to 92% and 93% respectively, with a 1- sided alpha of 0.05.||1.69|0.49|0.40
71145194|NCT01576341|141784088|OTHER||Incidence rate|0.019|||||TWO_SIDED||||||||Incidence rate is based on duration of treatment period (years)|||||
71145195|NCT03413891|141784168|SUPERIORITY||Risk Ratio (RR)|0.93|||=|0.72|TWO_SIDED|95.0|0.6|1.42|||Chi-squared|||||1.42|0.60|=0.72
70871056|NCT03633695|141227000|SUPERIORITY||Mean Difference (Final Values)|-0.191|||<|0.0001|TWO_SIDED|95.0|-0.223|-0.158||The threshold for statistical significance was p=0.05.|t-test, 2 sided||Acuity Difference = IC-8 Group - Control Group|The null hypothesis was that the mean acuity for the IC-8 Group was greater (i.e. worse) than or equal to that for the Control Group. The alternative hypothesis was that the mean for the IC-8 Group less (i.e., better) than that for the Control Group.||-0.158|-0.223|<.0001
71145196|NCT03413891|141784170|SUPERIORITY||Rate Ratio|0.76|||=|0.36|TWO_SIDED|95.0|0.42|1.37|||negative-binomial regression|||||1.37|0.42|=0.36
71145197|NCT03413891|141784171|SUPERIORITY||Rate Ratio|0.32|||=|0.03|TWO_SIDED|95.0|0.12|0.89|||negative-binomial regression|||||0.89|0.12|=0.03
71145198|NCT03413891|141784172|SUPERIORITY||Rate Ratio|0.6|||=|0.11|TWO_SIDED|95.0|0.32|1.12|||negative-binomial regression|||||1.12|0.32|=0.11
71145199|NCT03413891|141784173|SUPERIORITY||Rate Ratio|0.42|||=|0.15|TWO_SIDED|95.0|0.13|1.38|||negative-binomial regression|||||1.38|0.13|=0.15
71145200|NCT03413891|141784175|SUPERIORITY||Rate Ratio|0.57|||=|0.37|TWO_SIDED|95.0|0.17|1.91|||negative-binomial regression|||||1.91|0.17|=0.37
71145201|NCT03413891|141784176|SUPERIORITY||Risk Ratio (RR)|0.7|||=|0.66|TWO_SIDED|95.0|0.26|1.91|||Chi-squared|||||1.91|0.26|=0.66
70871057|NCT03633695|141227001|NON_INFERIORITY|Non-inferiority margin was 0.1 logMAR.|Mean Difference (Final Values)|-0.012|||<|0.0001|ONE_SIDED|95.0||0.007||The threshold for statistical significance was p=0.05.|t-test, 1 sided||Acuity Difference = IC-8 IOL Group - Control Group|The null hypothesis was that the mean acuity for the IC-8 IOL Group is inferior to the Control Group by 0.1 logMAR or more. The alternative hypothesis was that the mean acuity for the IC-8 IOL group is inferior to the Control Group by less than 0.1 logMAR.||0.007||<.0001
71145202|NCT03413891|141784177|SUPERIORITY||Rate Ratio|0.4|||=|0.04|TWO_SIDED|95.0|0.16|0.98|||negative-binomial regression|||||0.98|0.16|=0.04
71145203|NCT03413891|141784178|SUPERIORITY||Rate Ratio|0.37|||<|0.01|TWO_SIDED|95.0|0.18|0.78|||negative-binomial regression|||||0.78|0.18|<0.01
71145204|NCT04905134|141784205|OTHER|||||||0.04|||||||Fisher Exact|||Flexible scope compared with the SOC scope||||0.04
71145205|NCT02234843|141784266|OTHER||Hazard Ratio (HR)|0.4||||0.1509|TWO_SIDED|95.0|0.11|1.41|||Expl. Cox Proportional Hazards Model|||||1.41|0.11|0.1509
71145206|NCT03905096|141784301|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|92.63|STANDARD_DEVIATION|12.4|||TWO_SIDED|90.0|85.34|100.53|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||100.53|85.34|
71145207|NCT03905096|141784302|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|98.64|STANDARD_DEVIATION|6.9|||TWO_SIDED|90.0|93.21|104.39|||ANOVA|"The statistical model was ANOVA on the logarithmic scale considering the effect subjects as random and the effect treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||104.39|93.21|
71145208|NCT03905096|141784303|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|98.48|STANDARD_DEVIATION|12.4|||TWO_SIDED|90.0|90.74|106.88|||ANOVA|"The statistical model was ANOVA on the logarithmic scale considering the effect subjects as random and the effect treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||106.88|90.74|
71145209|NCT03905096|141784304|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|100.15|STANDARD_DEVIATION|14.4|||TWO_SIDED|90.0|89.01|112.68|||ANOVA|"The statistical model was ANOVA on the logarithmic scale considering the effect subjects as random and the effect treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||112.68|89.01|
71145210|NCT03905096|141784305|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|94.77|STANDARD_DEVIATION|10.6|||TWO_SIDED|90.0|88.36|101.64|||ANOVA|"The statistical model was ANOVA on the logarithmic scale considering the effect subjects as random and the effect treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||101.64|88.36|
71145211|NCT03905096|141784306|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|100.06|STANDARD_DEVIATION|6.9|||TWO_SIDED|90.0|94.56|105.87|||ANOVA|"The statistical model was ANOVA on the logarithmic scale considering the effect subjects as random and the effect treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||105.87|94.56|
71145212|NCT02016781|141784307|SUPERIORITY|||||||0.0001||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Wald test|Wald test of difference in adjusted OS estimates.||The null hypothesis is that the rates of three-year OS are the same for both treatments. The results posted are from the interim analysis per protocol study design.||||0.0001
71145213|NCT02016781|141784307|SUPERIORITY|||||||0.3345||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|Overall Wald test of interaction terms between response to hypomethylating therapy and treatment assignment in regression model.||This subgroup analysis investigated the differential impact of response to hypomethylating therapy (No Response to Hypomethylation vs. Any Response or Hematologic Improvement to Hypomethylation vs. No Prior Hypomethylation) on the treatment effect for OS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.3345
70953159|NCT01240915|141407990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.158||0.62|TWO_SIDED|80.0|-0.16|0.25||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 8)||0.25|-0.16|0.62
70953160|NCT01240915|141407990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.213||0.29|TWO_SIDED|80.0|-0.39|0.16||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 12)||0.16|-0.39|0.29
70953161|NCT01240915|141407990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.209||0.74|TWO_SIDED|80.0|-0.14|0.4||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 12)||0.40|-0.14|0.74
70953162|NCT01240915|141407990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.226||0.36|TWO_SIDED|80.0|-0.37|0.21||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 12)||0.21|-0.37|0.36
71145214|NCT02016781|141784307|SUPERIORITY|||||||0.7328||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|Overall Wald test of interaction terms between patient age and treatment assignment in regression model.||This subgroup analysis investigated the differential impact of patient age (\< vs. \>= 65) on the treatment effect for OS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.7328
71145215|NCT02016781|141784307|SUPERIORITY|||||||0.6261||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|Overall Wald test of interaction terms between disease duration and treatment assignment in regression model.||This subgroup analysis investigated the differential impact of disease duration (less than vs. 3 months or more) on the treatment effect for OS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.6261
71145216|NCT02016781|141784307|SUPERIORITY|||||||0.4134||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|Overall Wald test of interaction terms between IPSS score and treatment assignment in regression model.||This subgroup analysis investigated the differential impact of IPSS score (Intermediate-2 vs. High) on the treatment effect for OS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.4134
71145217|NCT02016781|141784307|SUPERIORITY|||||||0.3147||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|Overall Wald test of interaction terms between IPSS-R score and treatment assignment in regression model.||Statistical Analysis 6: This subgroup analysis investigated the differential impact of IPSS-R score (Very Low, Low, or Intermediate vs. High vs. Very High) on the treatment effect for OS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.3147
71145218|NCT02016781|141784308|SUPERIORITY|||||||0.003||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Wald test|||The null hypothesis is that the rates of three-year LFS are the same for both treatments.||||0.0030
71145219|NCT02016781|141784308|SUPERIORITY|||||||0.9908||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|||This subgroup analysis investigated the differential impact of response to hypomethylating therapy on the treatment effect for LFS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.9908
71145220|NCT02016781|141784308|SUPERIORITY|||||||0.8981||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|||This subgroup analysis investigated the differential impact of patient age (\< or \>= 65) on the treatment effect for LFS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.8981
71145221|NCT02016781|141784308|SUPERIORITY|||||||0.1465||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|||This subgroup analysis investigated the differential impact of disease duration (less than vs. 3 months or more) on the treatment effect for LFS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.1465
71145222|NCT02016781|141784308|SUPERIORITY|Statistical significance was determined using a pre-specified threshold of 0.05.||||||0.4991|||||||pseudo-value regression models|||This subgroup analysis investigated the differential impact of IPSS score (Intermediate-2 vs. High) on the treatment effect for LFS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.4991
70953163|NCT01240915|141407990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.234||0.56|TWO_SIDED|80.0|-0.26|0.34||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 16)||0.34|-0.26|0.56
70953164|NCT01240915|141407990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.231||0.18|TWO_SIDED|80.0|-0.51|0.09||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 16)||0.09|-0.51|0.18
70953165|NCT01240915|141407990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.25||0.31|TWO_SIDED|80.0|-0.45|0.2||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 16)||0.20|-0.45|0.31
70953166|NCT02574845|141407993|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T1/REF (%)|101.95|||||TWO_SIDED|90.0|89.49|116.15|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 10 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||116.15|89.49|
70953167|NCT02574845|141407993|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T2/REF (%)|106.09|||||TWO_SIDED|90.0|96.12|117.11|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 50 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||117.11|96.12|
70953168|NCT02574845|141407993|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T3/REF (%)|152.18|||||TWO_SIDED|90.0|135.12|171.41|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 500 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||171.41|135.12|
70953169|NCT02574845|141407993|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T4/REF (%)|106.97|||||TWO_SIDED|90.0|94.34|121.3|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 1 mg furosemide on the primary outcome measure of the REF treatment.||121.30|94.34|
70953170|NCT02574845|141407993|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T5/REF (%)|115.92|||||TWO_SIDED|90.0|101.93|131.82|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 5 mg furosemide on the primary outcome measure of the REF treatment.||131.82|101.93|
71145223|NCT02016781|141784308|SUPERIORITY|||||||0.4953||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|||This subgroup analysis investigated the differential impact of IPSS-R score on the treatment effect for LFS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.4953
70871058|NCT03633695|141227002|SUPERIORITY||Mean Difference (Final Values)|-0.18|||<|0.0001|TWO_SIDED|95.0|-0.198|-0.163||The threshold for statistical significance was p=0.05.|t-test, 2 sided||Acuity Difference = IC-8 IOL Eye (IC-8 IOL Group) - Fellow Eye (IC-8 IOL Group)|The null hypothesis was that the mean acuity for the IC-8 IOL eyes is greater (i.e., worse) than or equal to that for the fellow eyes. The alternative hypothesis was that the mean for the IC-8 IOL eyes is less (i.e., better) than that for the fellow eyes.||-0.163|-0.198|<.0001
70871059|NCT03633695|141227003|OTHER||Difference in depth of focus|0.91|||||TWO_SIDED||||||||Difference in depth of focus \[IC-8™ IOL Eyes (IC-8™ IOL Group) - Fellow Eyes (IC-8™ IOL Group)\]|||||
70953171|NCT02574845|141407994|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T1/REF (%)|102.47|||||TWO_SIDED|90.0|87.19|120.42|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 10 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||120.42|87.19|
70953172|NCT02574845|141407994|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T2/REF (%)|106.98|||||TWO_SIDED|90.0|92.54|123.69|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 50 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||123.69|92.54|
70953173|NCT02574845|141407994|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T3/REF (%)|154.07|||||TWO_SIDED|90.0|131.7|180.24|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 500 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||180.24|131.70|
70953174|NCT02574845|141407994|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T4/REF (%)|106.81|||||TWO_SIDED|90.0|91.78|124.3|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 1 mg furosemide on the primary outcome measure of the REF treatment.||124.30|91.78|
71145224|NCT02016781|141784309|SUPERIORITY|||||||0.2777||||||Statistical significance was determined using a pre-specified threshold of 0.05.|t-test, 2 sided|||The null hypothesis is that the FACT-G scores are the same at Enrollment for both treatments.||||0.2777
70871060|NCT03633695|141227004|NON_INFERIORITY|The non-inferiority margin was 0.1 logMAR.|Mean Difference (Final Values)|0.068|||<|0.0001|ONE_SIDED|95.0||0.082||The threshold for statistical significance was p=0.05.|t-test, 1 sided||Acuity Difference = IC-8 IOL Eyes (IC-8 Group) - Fellow Eyes (IC-8 Group)|The null hypothesis was that the mean acuity for the IC-8 IOL eyes was inferior to the fellow eyes by 0.1 logMAR or more. The alternative hypothesis was that the mean acuity for the IC-8 eyes was inferior to the fellow eyes by less than 0.1 logMAR.||0.082||<.0001
70953175|NCT02574845|141407994|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T5/REF (%)|117.98|||||TWO_SIDED|90.0|98.27|141.65|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 5 mg furosemide on the primary outcome measure of the REF treatment.||141.65|98.27|
70953176|NCT02574845|141407995|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T1/REF (%)|101.22|||||TWO_SIDED|90.0|89.23|114.82|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 10 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||114.82|89.23|
70953177|NCT02574845|141407995|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T2/REF (%)|107.26|||||TWO_SIDED|90.0|97.65|117.81|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 50 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||117.81|97.65|
70953178|NCT02574845|141407995|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T3/REF (%)|146.45|||||TWO_SIDED|90.0|135.21|158.62|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 500 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||158.62|135.21|
70953179|NCT02574845|141407995|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T4/REF (%)|105.63|||||TWO_SIDED|90.0|92.2|121.0|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 1 mg furosemide on the primary outcome measure of the REF treatment.||121.00|92.20|
70953180|NCT02574845|141407995|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T5/REF (%)|118.1|||||TWO_SIDED|90.0|106.75|130.67|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 5 mg furosemide on the primary outcome measure of the REF treatment.||130.67|106.75|
70871061|NCT03633695|141227012|NON_INFERIORITY|Non-inferiority margin was 0.12 logMAR.|Mean Difference (Final Values)|0.023|||<|0.0001|TWO_SIDED|95.0||||The threshold for statistical significance was p=0.05.|t-test, 1 sided|||The null hypothesis was that the mean acuity in Astigmatism Group 2 was inferior to the Astigmatism Group 1 by 0.12 logMAR or more. The alternative hypothesis was that the mean acuity in Astigmatism Group 2 was inferior to Astigmatism Group 1 by less than 0.12 logMAR.||||<.0001
70871062|NCT02728050|141227023|SUPERIORITY|||||||0.48|||||||Fisher Exact|||"Participants on study receiving CLAGM-S were compared to a historical cohort of newly diagnosed AML/high-risk MDS patients treated with CLAG-M alone, matched for mitoxantrone dose, age, and TRM score.~Number of participants in historical cohort = 71. Number of participants in historical cohort who achieved MRD-negative CR = 55 (77.46%)"||||0.48
70871063|NCT05275400|141227037|NON_INFERIORITY|Noninferiority margin (NIM) was 0.4%|LS Mean Difference|-0.089|||||TWO_SIDED|95.0|-0.191|0.013||||||||0.013|-0.191|
70871064|NCT05275400|141227038|SUPERIORITY||LS Mean Difference|-0.089||||0.088|TWO_SIDED|95.0|-0.191|0.013|||ANCOVA|||||0.013|-0.191|0.088
70871065|NCT05275400|141227039|SUPERIORITY||Relative rate|1.03||||0.897|TWO_SIDED|95.0|0.62|1.74|||Negative binomial model|||||1.74|0.62|0.897
70871066|NCT05275400|141227040|SUPERIORITY||LS Mean Difference|0.42||||0.722|TWO_SIDED|95.0|-1.88|2.72|||ANCOVA|||||2.72|-1.88|0.722
70871067|NCT05275400|141227041|SUPERIORITY||LS Mean Difference|-0.84||||0.605|TWO_SIDED|95.0|-4.01|2.33|||ANCOVA|||||2.33|-4.01|0.605
70871068|NCT05275400|141227042|SUPERIORITY||LS Mean Difference|-30.0||||0.003|TWO_SIDED|95.0|-50.1|-9.97|||Mixed Models Analysis|||||-9.97|-50.10|0.003
70871069|NCT05275400|141227043|SUPERIORITY||Relative rate|1.14||||0.43|TWO_SIDED|95.0|0.83|1.56|||Negative binomial model|||||1.56|0.83|0.430
70871070|NCT05275400|141227044|SUPERIORITY||LS Mean Difference|0.071||||0.756|TWO_SIDED|95.0|-0.38|0.52|||Mixed Models Analysis|||||0.52|-0.38|0.756
70871071|NCT05275400|141227045|SUPERIORITY||LS Mean Difference|0.14||||0.021|TWO_SIDED|95.0|0.02|0.27|||ANCOVA|||||0.27|0.02|0.021
70871072|NCT05275400|141227046|SUPERIORITY||LS Mean Difference|-0.99||||0.417|TWO_SIDED|95.0|-3.37|1.4|||ANCOVA|||||1.40|-3.37|0.417
70871073|NCT05275400|141227047|SUPERIORITY||LS Mean Difference|3.15|||<|0.001|TWO_SIDED|95.0|1.71|4.59|||Mixed Models Analysis|||Week 26||4.59|1.71|<0.001
70871074|NCT05275400|141227047|SUPERIORITY||LS Mean Difference|3.56|||<|0.001|TWO_SIDED|95.0|2.05|5.07|||Mixed Models Analysis|||Week 52||5.07|2.05|<0.001
70871075|NCT05275400|141227047|SUPERIORITY||LS Mean Difference|3.35|||<|0.001|TWO_SIDED|95.0|1.75|4.94|||Mixed Models Analysis|||Week 78||4.94|1.75|<0.001
70871076|NCT02197247|141227128|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|No effect on the PK of AZD9291 after co-administration of rifampicin was concluded if the lower bound of the 90% confidence intervals (CIs) for the ratios (Period 2 versus Period 1) of AZD9291 AUCtau and Css,max were both above 50%. The experiment-wide power for the ratios being above 50% was 90% (95% power for each parameter).|Geometric least-squares (LS) mean ratio|27.16|||||TWO_SIDED|90.0|24.36|30.29|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1).|Natural log-transformed Css,max values were compared between periods using a mixed effects analysis of variance (ANOVA) with period as fixed effect and patient as random effect. It was assumed the within-patient coefficient of variation for AZD9291 in both area under the plasma concentration-time curve during the dosing interval (AUCtau) and Cmax was 34%. A 33% decrease in exposure for AZD9291 when given with rifampicin was also assumed.||30.29|24.36|
70871077|NCT02197247|141227129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|No effect on the PK of AZD9291 after co-administration of rifampicin was concluded if the lower bound of the 90% CIs for the ratios (Period 2 versus Period 1) of AZD9291 AUCtau and Css,max were both above 50%. The experiment-wide power for the ratios being above 50% was 90% (95% power for each parameter).|Geometric LS Mean Ratio|21.55|||||TWO_SIDED|90.0|19.5|23.83|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1).|Natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as fixed effect and patient as random effect. It was assumed the within-patient coefficient of variation for AZD9291 in both AUCtau and Cmax was 34%. A 33% decrease in exposure for AZD9291 when given with rifampicin was also assumed.||23.83|19.50|
70953181|NCT04091061|141408007|OTHER|90% Confidence Intervals (CIs) for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|156.99|||||TWO_SIDED|90.0|83.14|296.44|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference.|||296.44|83.14|
70953182|NCT04091061|141408007|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|125.58|||||TWO_SIDED|90.0|66.51|237.13|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||237.13|66.51|
70953183|NCT04091061|141408007|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|123.75|||||TWO_SIDED|90.0|65.54|233.68|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||233.68|65.54|
70953184|NCT04091061|141408008|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|156.25|||||TWO_SIDED|90.0|81.07|301.16|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||301.16|81.07|
70953185|NCT04091061|141408008|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|165.66|||||TWO_SIDED|90.0|85.95|319.29|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||319.29|85.95|
70953186|NCT04091061|141408008|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|152.18|||||TWO_SIDED|90.0|78.96|293.32|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||293.32|78.96|
70953187|NCT04091061|141408009|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|156.0|||||TWO_SIDED|90.0|80.95|300.6|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||300.60|80.95|
70953188|NCT04091061|141408009|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|165.38|||||TWO_SIDED|90.0|85.82|318.67|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||318.67|85.82|
70953189|NCT04091061|141408009|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|152.2|||||TWO_SIDED|90.0|78.99|293.29|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||293.29|78.99|
70953190|NCT00821587|141408014|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|95.0||||We hypothesize that subjects on CsA are more likely to achieve undetectable viral level in patients receiving antiviral therapy for recurrent HCV after Liver Transplant|Chi-squared|||We hypothesize that subjects on CsA are more likely to achieve undetectable viral levels after liver transplant. Comparisons between the two groups (Undetectable viral level vs. Detectable viral level) were performed with Pearson Chi-square tests or Fisher's exact test for categorical variables, and Mann-Whitney U test for continuous variables.||||<0.05
70953191|NCT01712061|141408019|SUPERIORITY_OR_OTHER||Ratio of geometric mean changes|0.92|||||TWO_SIDED|95.0|0.75|1.09|||ANCOVA|Bayesian ANCOVA with covariates for baseline UACR and systolic blood pressure (SBP).||||1.09|0.75|
70953192|NCT03846453|141408057|SUPERIORITY||Least Squares (LS) Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.064||0.1871|TWO_SIDED|95.0|-0.04|0.21||P-value calculated using a model with treatment, baseline score, and site as covariates.|ANCOVA|||||0.21|-0.04|0.1871
70871078|NCT02197247|141227130|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|95.53|||||TWO_SIDED|90.0|85.27|107.03|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for AZD9291 alone in separate periods, but analysed for consistency with AZD9291+rifampicin / AZD9291 alone analysis (primary outcome measure).|Natural log-transformed Css,max values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||107.03|85.27|
70953193|NCT03846453|141408058|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.09||0.5549|TWO_SIDED|95.0|-0.12|0.23|||ANCOVA|P-value calculated using a model with treatment, baseline score, and site as covariates.||||0.23|-0.12|0.5549
70871079|NCT02197247|141227131|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|21.72|||||TWO_SIDED|90.0|19.08|24.72|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ5104 (metabolite), natural log-transformed Css,max values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||24.72|19.08|
70953194|NCT02145468|141408120|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.238|TWO_SIDED|95.0|0.91|1.47|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|||1.47|0.91|0.238
70953195|NCT02145468|141408121|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.329|TWO_SIDED|95.0|0.9|1.38|||Log Rank||"Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk.~with the treatment compared with placebo."|||1.38|0.90|0.329
70953196|NCT02145468|141408122|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.338|TWO_SIDED|95.0|0.88|1.47|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|CV death or MI, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.47|0.88|0.338
71145225|NCT02016781|141784309|SUPERIORITY|||||||0.225||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in FACT-G scores from enrollment are the same at 6 Months for both treatments.||||0.2250
70953197|NCT02145468|141408122|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.41|TWO_SIDED|95.0|0.88|1.38|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|CV death or MI, Placebo Vs Losmapimod 7.5 mg BID at Week 24||1.38|0.88|0.410
70953198|NCT02145468|141408123|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.472|TWO_SIDED|95.0|0.86|1.38|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|CV death, MI or hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.38|0.86|0.472
70953199|NCT02145468|141408124|SUPERIORITY||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.91|1.44|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of arterial CV events (CV death, MI, SRI-UR or stroke), Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.44|0.91|
70953200|NCT02145468|141408125|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.505|TWO_SIDED|95.0|0.86|1.36|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of coronary events (CHD death, MI, SRI-UR or any unplanned coronary artery revascularization), Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.36|0.86|0.505
70953201|NCT02145468|141408126|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.536|TWO_SIDED|95.0|0.64|1.26|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death or hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.26|0.64|0.536
70953202|NCT02145468|141408126|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.6|TWO_SIDED|95.0|0.69|1.24|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death or hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 24||1.24|0.69|0.6
70953203|NCT02145468|141408127|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.356|TWO_SIDED|95.0|0.88|1.43|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death, MI or stroke, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.43|0.88|0.356
70953204|NCT02145468|141408128|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.329|TWO_SIDED|95.0|0.9|1.39|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death, MI, SRI-UR, stroke or hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.39|0.9|0.329
70953205|NCT02145468|141408129|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.285|TWO_SIDED|95.0|0.89|1.47|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CHD death, MI or SRI-UR, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.47|0.89|0.285
70953206|NCT02145468|141408130|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.401|TWO_SIDED|95.0|0.86|1.46|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CHD death or MI, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.46|0.86|0.401
70953207|NCT02145468|141408131|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.295|TWO_SIDED|95.0|0.89|1.44|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of all-cause death, MI or SRI-UR,Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.44|0.89|0.295
71145226|NCT02016781|141784309|SUPERIORITY|||||||0.1048||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in FACT-G scores from enrollment are the same at 12 Months for both treatments.||||0.1048
70953208|NCT02145468|141408132|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.412|TWO_SIDED|95.0|0.86|1.43|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of all-cause death or MI, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.43|0.86|0.412
70953209|NCT02145468|141408133|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.469|TWO_SIDED|95.0|0.83|1.49|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death, type I (spontaneous) MI or SRI-UR, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.49|0.83|0.469
71145227|NCT02016781|141784309|SUPERIORITY|||||||0.0888||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in FACT-G scores from enrollment are the same at 18 Months for both treatments.||||0.0888
71145228|NCT02016781|141784309|SUPERIORITY|||||||0.5844||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in FACT-G scores from enrollment are the same at 24 Months for both treatments.||||0.5844
70953210|NCT02145468|141408134|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.664|TWO_SIDED|95.0|0.78|1.48|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death or type I (spontaneous) MI, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.48|0.78|0.664
70953211|NCT02145468|141408135|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.13|TWO_SIDED|95.0|0.27|1.19|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Participants with first occurrence of definite or probable stent thrombosis, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.19|0.27|0.130
70953212|NCT02145468|141408136|SUPERIORITY||Odds Ratio (OR)|1.03||||0.744|TWO_SIDED|95.0|0.84|1.27|||Wald chi-squared||Odds ratio is estimated using a logistic regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. An odds ratio \<1 indicates a lower risk with the treatment compared with placebo.|||1.27|0.84|0.744
70953213|NCT02145468|141408137|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.309|TWO_SIDED|95.0|0.53|1.22|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Participants with all-cause mortality, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.22|0.53|0.309
70953214|NCT02145468|141408138|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.398|TWO_SIDED|95.0|0.53|1.28|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|CV death events, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.28|0.53|0.398
70953215|NCT02145468|141408138|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.264|TWO_SIDED|95.0|0.55|1.18|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|CV death events, Placebo Vs Losmapimod 7.5 mg BID at Week 24||1.18|0.55|0.264
70953216|NCT02145468|141408139|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.251|TWO_SIDED|95.0|0.47|1.22|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|CHD death events, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.22|0.47|0.251
70953217|NCT02145468|141408140|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.182|TWO_SIDED|95.0|0.91|1.67|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Myocardial infarction (fatal and non-fatal) events, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.67|0.91|0.182
70953218|NCT02145468|141408140|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.158|TWO_SIDED|95.0|0.93|1.58|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Myocardial infarction (fatal and non-fatal) events, Placebo Vs Losmapimod 7.5 mg BID at Week 24||1.58|0.93|0.158
70953219|NCT02145468|141408141|SUPERIORITY||Hazard Ratio (HR)|1.34||||0.21|TWO_SIDED|95.0|0.85|2.12|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Type I (spontaneous) MI events, Placebo Vs Losmapimod 7.5 mg BID at Week 12||2.12|0.85|0.21
70953220|NCT02145468|141408142|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.697|TWO_SIDED|95.0|0.58|2.24|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|SRI-UR events, Placebo Vs Losmapimod 7.5 mg BID at Week 12||2.24|0.58|0.697
70953221|NCT02145468|141408143|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.883|TWO_SIDED|95.0|0.46|1.96|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Stroke (fatal and non-fatal) events, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.96|0.46|0.883
70953222|NCT02145468|141408144|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.457|TWO_SIDED|95.0|0.54|1.32|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.32|0.54|0.457
70953223|NCT02145468|141408144|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.736|TWO_SIDED|95.0|0.63|1.38|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 24||1.38|0.63|0.736
70953224|NCT02145468|141408145|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.581|TWO_SIDED|95.0|0.77|1.59|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Any unplanned coronary revascularization, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.59|0.77|0.581
70871080|NCT02197247|141227131|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|88.31|||||TWO_SIDED|90.0|77.17|101.07|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ5104 (metabolite), natural log-transformed Css,max values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||101.07|77.17|
70953225|NCT04655027|141408167|OTHER|Treatment effect|Difference in Estimate (LSM)|19.5|STANDARD_ERROR_OF_MEAN|15.62||0.212|TWO_SIDED|95.0|-11.155|50.15|||ANCOVA|||||50.150|-11.155|0.212
70953226|NCT04655027|141408168|OTHER|Baseline hepcidin by treatment effect|Difference in Estimate|-0.13|STANDARD_ERROR_OF_MEAN|0.17||0.441|TWO_SIDED|95.0|-0.477|0.208|||ANCOVA|||||0.208|-0.477|0.441
70953227|NCT04655027|141408168|OTHER|Baseline hs CRP by treatment effect|Difference in Estimates|-2.34|STANDARD_ERROR_OF_MEAN|3.76||0.532|TWO_SIDED|95.0|-9.707|5.017|||ANCOVA|||||5.017|-9.707|0.532
70953228|NCT04655027|141408169|OTHER|Treatment effect|Ratio of Estimates|1.09|STANDARD_ERROR_OF_MEAN|1.23||0.688|TWO_SIDED|95.0|0.723|1.635|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||1.635|0.723|0.688
70953229|NCT04655027|141408169|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|0.43|STANDARD_ERROR_OF_MEAN|0.2||0.029|TWO_SIDED|95.0|0.045|0.822|||ANCOVA|||||0.822|0.045|0.029
70953230|NCT04655027|141408169|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|0.08|STANDARD_ERROR_OF_MEAN|0.14||0.568|TWO_SIDED|95.0|-0.201|0.366|||ANCOVA|||||0.366|-0.201|0.568
70953231|NCT04655027|141408170|OTHER|Treatment effect|Ratio of Estimates|0.84|STANDARD_ERROR_OF_MEAN|1.11||0.096|TWO_SIDED|95.0|0.687|1.031|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||1.031|0.687|0.096
70953232|NCT04655027|141408170|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|-0.06|STANDARD_ERROR_OF_MEAN|0.12||0.63|TWO_SIDED|95.0|-0.282|0.171|||ANCOVA|||||0.171|-0.282|0.630
70953233|NCT04655027|141408170|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|0.19|STANDARD_ERROR_OF_MEAN|0.08||0.015|TWO_SIDED|95.0|0.037|0.342|||ANCOVA|||||0.342|0.037|0.015
70953234|NCT04655027|141408171|OTHER|Treatment effect|Ratio of Estimates|1.23|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED|95.0|1.123|1.354|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||1.354|1.123|< 0.001
70953235|NCT04655027|141408171|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|0.06|STANDARD_ERROR_OF_MEAN|0.04||0.171|TWO_SIDED|95.0|-0.027|0.149|||ANCOVA|||||0.149|-0.027|0.171
70953236|NCT04655027|141408171|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|0.03|STANDARD_ERROR_OF_MEAN|0.04||0.387|TWO_SIDED|95.0|-0.039|0.101|||ANCOVA|||||0.101|-0.039|0.387
71145229|NCT02016781|141784309|SUPERIORITY|||||||0.0344||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in FACT-G scores from enrollment are the same at 36 Months for both treatments.||||0.0344
70871081|NCT02197247|141227132|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|139.32|||||TWO_SIDED|90.0|127.74|151.96|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ7550 (metabolite), natural log-transformed Css,max values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||151.96|127.74|
70953237|NCT04655027|141408172|OTHER|Treatment effect|Ratio of Estimates|0.89|STANDARD_ERROR_OF_MEAN|1.22||0.561|TWO_SIDED|95.0|0.606|1.312|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||1.312|0.606|0.561
70953238|NCT04655027|141408172|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|0.38|STANDARD_ERROR_OF_MEAN|0.19||0.043|TWO_SIDED|95.0|0.013|0.75|||ANCOVA|||||0.750|0.013|0.043
70953239|NCT04655027|141408172|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|0.04|STANDARD_ERROR_OF_MEAN|0.13||0.766|TWO_SIDED|95.0|-0.222|0.302|||ANCOVA|||||0.302|-0.222|0.766
70953240|NCT04655027|141408173|OTHER|Treatment effect|Ratio of Estimates|1.23|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED|95.0|1.108|1.369|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||1.369|1.108|< 0.001
70953241|NCT04655027|141408173|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.351|TWO_SIDED|95.0|-0.059|0.159|||ANCOVA|||||0.159|-0.059|0.351
70953242|NCT04655027|141408173|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|0.04|STANDARD_ERROR_OF_MEAN|0.03||0.248|TWO_SIDED|95.0|-0.031|0.114|||ANCOVA|||||0.114|-0.031|0.248
70953243|NCT04655027|141408174|OTHER|Treatment effect|Ratio of Estimates|1.29|STANDARD_ERROR_OF_MEAN|1.11||0.021|TWO_SIDED|95.0|1.043|1.598|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||1.598|1.043|0.021
70953244|NCT04655027|141408174|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|-0.03|STANDARD_ERROR_OF_MEAN|0.12||0.826|TWO_SIDED|95.0|-0.276|0.223|||ANCOVA|||||0.223|-0.276|0.826
70953245|NCT04655027|141408174|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.634|TWO_SIDED|95.0|-0.212|0.132|||ANCOVA|||||0.132|-0.212|0.634
70953246|NCT04655027|141408175|OTHER|Treatment effect|Ratio of Estimates|0.45|STANDARD_ERROR_OF_MEAN|1.31||0.007|TWO_SIDED|95.0|0.257|0.786|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||0.786|0.257|0.007
70953247|NCT04655027|141408175|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|-0.16|STANDARD_ERROR_OF_MEAN|0.31||0.61|TWO_SIDED|95.0|-0.798|0.48|||ANCOVA|||||0.480|-0.798|0.610
70953248|NCT04655027|141408175|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|0.07|STANDARD_ERROR_OF_MEAN|0.22||0.74|TWO_SIDED|95.0|-0.387|0.536|||ANCOVA|||||0.536|-0.387|0.740
71145230|NCT02016781|141784310|SUPERIORITY|||||||0.5583||||||Statistical significance was determined using a pre-specified threshold of 0.05.|t-test, 2 sided|||The null hypothesis is that the MOS SF-36 PCS scores are the same at Enrollment for both treatments.||||0.5583
70953249|NCT03578887|141408252|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
70953250|NCT03578887|141408253|SUPERIORITY|||||||0.85|||||||ANOVA|||||||0.85
70953251|NCT01531673|141408273|SUPERIORITY||Least Squares (LS) Mean Difference|4.77||||0.0647|TWO_SIDED|95.0|-0.3|9.84|||Mixed-effect repeated measure (MMRM)|||||9.84|-0.3|0.0647
70953252|NCT01531673|141408273|SUPERIORITY||LS Mean Difference|-3.91||||0.1686|TWO_SIDED|95.0|-9.5|1.68|||MMRM|||||1.68|-9.5|0.1686
70953253|NCT01531673|141408273|SUPERIORITY||LS Mean Difference|-4.2||||0.0348|TWO_SIDED|95.0|-8.1|-0.31|||MMRM|||||-0.31|-8.1|0.0348
70953254|NCT01531673|141408273|SUPERIORITY||LS Mean Difference|-19.58|||<|0.0001|TWO_SIDED|95.0|-24.57|-14.59|||MMRM|||||-14.59|-24.57|<0.0001
70953255|NCT01531673|141408273|SUPERIORITY||LS Mean Difference|-5.14||||0.0101|TWO_SIDED|95.0|-9.03|-1.25|||MMRM|||||-1.25|-9.03|0.0101
70953256|NCT01531673|141408273|SUPERIORITY||LS Mean Difference|-5.19||||0.011|TWO_SIDED|95.0|-9.16|-1.21|||MMRM|||||-1.21|-9.16|0.011
70953257|NCT01531673|141408273|SUPERIORITY||LS Mean Difference|-9.6||||0.0001|TWO_SIDED|95.0|-14.38|-4.82|||MMRM|||||-4.82|-14.38|0.0001
70953258|NCT01531673|141408273|SUPERIORITY||LS Mean Difference|-1.77||||0.3745|TWO_SIDED|95.0|-5.71|2.17|||MMRM|||||2.17|-5.71|0.3745
70953259|NCT01531673|141408274|SUPERIORITY||LS Mean Difference|-6.7||||0.0357|TWO_SIDED|95.0|-12.94|-0.46|||MMRM|||||-0.46|-12.94|0.0357
70953260|NCT01531673|141408275|SUPERIORITY||LS Mean Difference|-17.2||||0.0238|TWO_SIDED|95.0|-31.75|-2.65|||MMRM|||||-2.65|-31.75|0.0238
70953261|NCT02187159|141408290|SUPERIORITY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.183||0.0008|TWO_SIDED|95.0|-0.97|-0.25|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||-0.25|-0.97|0.0008
70953262|NCT02187159|141408290|SUPERIORITY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.183||0.0392|TWO_SIDED|95.0|-0.74|-0.02|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||-0.02|-0.74|0.0392
70953263|NCT02187159|141408290|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.183||0.2192|TWO_SIDED|95.0|-0.58|0.13|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||0.13|-0.58|0.2192
70953264|NCT02187159|141408290|SUPERIORITY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.184||0.2095|TWO_SIDED|95.0|-0.13|0.59|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||0.59|-0.13|0.2095
70953265|NCT02187159|141408290|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.185||0.0381|TWO_SIDED|95.0|0.02|0.75|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||0.75|0.02|0.0381
70953266|NCT02187159|141408292|SUPERIORITY||Mean Difference (Final Values)|-7.67|STANDARD_ERROR_OF_MEAN|1.598|<|0.0001|TWO_SIDED|95.0|-10.71|-4.44|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||-4.44|-10.71|<0.0001
70953267|NCT02187159|141408292|SUPERIORITY||Mean Difference (Final Values)|-3.52|STANDARD_ERROR_OF_MEAN|1.613||0.0289|TWO_SIDED|95.0|-6.68|-0.36|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||-0.36|-6.68|0.0289
70953268|NCT02187159|141408292|SUPERIORITY||Mean Difference (Final Values)|-2.56|STANDARD_ERROR_OF_MEAN|1.625||0.1148|TWO_SIDED|95.0|-5.75|0.62|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||0.62|-5.75|0.1148
70953269|NCT02187159|141408292|SUPERIORITY||Mean Difference (Final Values)|4.05|STANDARD_ERROR_OF_MEAN|1.621||0.0125|TWO_SIDED|95.0|0.87|7.23|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||7.23|0.87|0.0125
70953270|NCT02187159|141408292|SUPERIORITY||Mean Difference (Final Values)|5.01|STANDARD_ERROR_OF_MEAN|1.647||0.0023|TWO_SIDED|95.0|1.78|8.24|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||8.24|1.78|0.0023
70953271|NCT02187159|141408294|SUPERIORITY||Difference in least squares means|-1.2|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|-1.8|-0.7|||ANCOVA|||||-0.7|-1.8|<0.0001
70953272|NCT02187159|141408294|SUPERIORITY||Difference in least squares means|-0.6|STANDARD_ERROR_OF_MEAN|0.29||0.0247|TWO_SIDED|95.0|-1.2|-0.1|||ANCOVA|||||-0.1|-1.2|0.0247
70953273|NCT02187159|141408294|SUPERIORITY||Difference in least squares means|-0.6|STANDARD_ERROR_OF_MEAN|0.29||0.0411|TWO_SIDED|95.0|-1.1|0.0|||ANCOVA|||||-0.0|-1.1|0.0411
70953274|NCT02187159|141408294|SUPERIORITY||Difference in least squares means|0.6|STANDARD_ERROR_OF_MEAN|0.29||0.0352|TWO_SIDED|95.0|0.0|1.2|||ANCOVA|||||1.2|0.0|0.0352
70953275|NCT02187159|141408294|SUPERIORITY||Difference in least squares means|0.7|STANDARD_ERROR_OF_MEAN|0.29||0.0214|TWO_SIDED|95.0|0.1|1.2|||ANCOVA|||||1.2|0.1|0.0214
70953276|NCT02187159|141408295|SUPERIORITY||Difference of least squares means|-0.9|STANDARD_ERROR_OF_MEAN|0.26||0.0003|TWO_SIDED|95.0|-1.5|-0.4|||ANCOVA|||Anxiety: Placebo vs Pregabalin 150 mg BID||-0.4|-1.5|0.0003
70953277|NCT02187159|141408295|SUPERIORITY||Difference of least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.26||0.5066|TWO_SIDED|95.0|-0.7|0.3|||ANCOVA|||Anxiety: Placebo vs DS-5565 15 mg QD||0.3|-0.7|0.5066
70953278|NCT02187159|141408295|SUPERIORITY||Difference of least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.26||0.1462|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||Anxiety: Placebo vs DS-5565 15 mg BID||0.1|-0.9|0.1462
70953279|NCT02187159|141408295|SUPERIORITY||Difference of least squares means|0.8|STANDARD_ERROR_OF_MEAN|0.26||0.0035|TWO_SIDED|95.0|0.3|1.3|||ANCOVA|||Anxiety: Pregabalin 150 mg BID vs DS-5565 15 mg QD||1.3|0.3|0.0035
70953280|NCT02187159|141408295|SUPERIORITY||Difference in least squares means|0.6|STANDARD_ERROR_OF_MEAN|0.26||0.0338|TWO_SIDED|95.0|0.0|1.1|||ANCOVA|||Anxiety: Pregabalin 150 mg BID vs DS-5565 15 mg BID||1.1|0.0|0.0338
70953281|NCT02187159|141408295|SUPERIORITY||Difference in least squares means|-0.7|STANDARD_ERROR_OF_MEAN|0.28||0.0116|TWO_SIDED|95.0|-1.3|-0.2|||ANCOVA|||Depression: Placebo vs Pregabalin 150 mg BID||-0.2|-1.3|0.0116
70953282|NCT02187159|141408295|SUPERIORITY||Difference of least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.28||0.7085|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||Depression: Placebo vs DS-5565 15 mg QD||0.4|-0.7|0.7085
70953283|NCT02187159|141408295|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.28||0.9392|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||Depression: Placebo vs DS-5565 15 mg BID||0.6|-0.5|0.9392
70953284|NCT02187159|141408295|SUPERIORITY||Difference in least squares means|0.6|STANDARD_ERROR_OF_MEAN|0.28||0.0311|TWO_SIDED|95.0|0.1|1.2|||ANCOVA|||Depression: Pregabalin 150 mg BID vs DS-5565 15 mg QD||1.2|0.1|0.0311
70953285|NCT02187159|141408295|SUPERIORITY||Difference in least squares means|0.7|STANDARD_ERROR_OF_MEAN|0.28||0.0094|TWO_SIDED|95.0|0.2|1.3|||ANCOVA|||Depression: Pregabalin 150 mg BID vs DS-5565 15 mg BID||1.3|0.2|0.0094
70953286|NCT02187159|141408296|SUPERIORITY||Difference in least squares means|1.256|STANDARD_ERROR_OF_MEAN|0.6027||0.0373|TWO_SIDED|95.0|0.074|2.439|||ANCOVA|||Physical Component: Placebo vs Pregabalin||2.439|0.074|0.0373
70953287|NCT02187159|141408296|SUPERIORITY||Difference of least squares means|0.364|STANDARD_ERROR_OF_MEAN|0.602||0.5458|TWO_SIDED|95.0|-0.817|1.545|||ANCOVA|||Physical Component: Placebo vs DS-5565 15 mg QD||1.545|-0.817|0.5458
70953288|NCT02187159|141408296|SUPERIORITY||Difference in least squares means|0.235|STANDARD_ERROR_OF_MEAN|0.6038||0.6968|TWO_SIDED|95.0|-0.949|1.42|||ANCOVA|||Physical Component: Placebo vs DS-5565 15 mg BID||1.420|-0.949|0.6968
70953289|NCT02187159|141408296|SUPERIORITY||Difference in least squares means|-0.893|STANDARD_ERROR_OF_MEAN|0.6014||0.1379|TWO_SIDED|95.0|-2.073|0.287|||ANCOVA|||Physical Component: Pregabalin vs DS-5565 15 mg QD||0.287|-2.073|0.1379
70953290|NCT02187159|141408296|SUPERIORITY||Difference in least squares means|-1.021|STANDARD_ERROR_OF_MEAN|0.6033||0.0908|TWO_SIDED|95.0|-2.205|0.163|||ANCOVA|||Physical Component: Pregabalin vs DS-5565 15 mg BID||0.163|-2.205|0.0908
70953291|NCT02187159|141408296|SUPERIORITY||Difference in least squares means|1.89|STANDARD_ERROR_OF_MEAN|0.6965||0.0068|TWO_SIDED|95.0|0.523|3.256|||ANCOVA|||Mental Component: Placebo vs Pregabalin||3.256|0.523|0.0068
71145231|NCT02016781|141784310|SUPERIORITY|||||||0.669||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 PCS scores from enrollment are the same at 6 Months for both treatments.||||0.6690
71145232|NCT02016781|141784310|SUPERIORITY|||||||0.2089||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 PCS scores from enrollment are the same at 12 Months for both treatments.||||0.2089
71145233|NCT02016781|141784310|SUPERIORITY|||||||0.4343||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 PCS scores from enrollment are the same at 18 Months for both treatments.||||0.4343
70871082|NCT02197247|141227132|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|100.75|||||TWO_SIDED|90.0|92.04|110.29|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ7550 (metabolite), natural log-transformed Css,max values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||110.29|92.04|
70871083|NCT02197247|141227134|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|95.89|||||TWO_SIDED|90.0|86.37|106.45|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for AZD9291 alone in separate periods, but analysed for consistency with AZD9291+rifampicin / AZD9291 alone analysis (primary outcome measure).|Natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||106.45|86.37|
70953292|NCT02187159|141408296|SUPERIORITY||Difference in least squares means|0.406|STANDARD_ERROR_OF_MEAN|0.6956||0.5594|TWO_SIDED|95.0|-0.959|1.771|||ANCOVA|||Mental Component: Placebo vs DS-5565 15 mg QD||1.771|-0.959|0.5594
70953293|NCT02187159|141408296|SUPERIORITY||Difference in least squares means|0.023|STANDARD_ERROR_OF_MEAN|0.6979||0.9736|TWO_SIDED|95.0|-1.346|1.392|||ANCOVA|||Mental Component: Placebo vs DS-5565 15 mg BID||1.392|-1.346|0.9736
70953294|NCT02187159|141408296|SUPERIORITY||Difference in least squares means|-1.484|STANDARD_ERROR_OF_MEAN|0.6953||0.0331|TWO_SIDED|95.0|-2.848|-0.119|||ANCOVA|||Mental Component: Pregabalin vs DS-5565 15 mg QD||-0.119|-2.848|0.0331
70953295|NCT02187159|141408296|SUPERIORITY||Difference in least squares means|-1.867|STANDARD_ERROR_OF_MEAN|0.6976||0.0076|TWO_SIDED|95.0|-3.235|-0.498|||ANCOVA|||Mental Component: Pregabalin vs DS-5565 15 mg BID||-0.498|-3.235|0.0076
70953296|NCT02187159|141408297|SUPERIORITY||Difference in least squares means|0.0309|STANDARD_ERROR_OF_MEAN|0.01328||0.0201|TWO_SIDED|95.0|0.0048|0.057|||ANCOVA|||||0.0570|0.0048|0.0201
70953297|NCT02187159|141408297|SUPERIORITY||Difference of least squares means|0.0178|STANDARD_ERROR_OF_MEAN|0.01324||0.1798|TWO_SIDED|95.0|-0.0082|0.0438|||ANCOVA|||||0.0438|-0.0082|0.1798
70953298|NCT02187159|141408297|SUPERIORITY||Difference of least squares means|0.0071|STANDARD_ERROR_OF_MEAN|0.01329||0.5922|TWO_SIDED|95.0|-0.0189|0.0332|||ANCOVA|||||0.0332|-0.0189|0.5922
70953299|NCT02187159|141408297|SUPERIORITY||Difference in least squares means|-0.0131|STANDARD_ERROR_OF_MEAN|0.01326||0.3221|TWO_SIDED|95.0|-0.0392|0.0129|||ANCOVA|||||0.0129|-0.0392|0.3221
70953300|NCT02187159|141408297|SUPERIORITY||Difference in least squares means|-0.0238|STANDARD_ERROR_OF_MEAN|0.0133||0.0739|TWO_SIDED|95.0|-0.0499|0.0023|||ANCOVA|||||0.0023|-0.0499|0.0739
70953301|NCT02187159|141408298|SUPERIORITY||Difference in least squares means|-0.49|STANDARD_ERROR_OF_MEAN|0.153||0.0015|TWO_SIDED|95.0|-0.79|-0.19|||Mixed Models Analysis|||||-0.19|-0.79|0.0015
70953302|NCT02187159|141408298|SUPERIORITY||Difference in least squares means|-0.56|STANDARD_ERROR_OF_MEAN|0.153||0.0003|TWO_SIDED|95.0|-0.86|-0.26|||Mixed Models Analysis|||||-0.26|-0.86|0.0003
70953303|NCT02187159|141408298|SUPERIORITY||Difference in least squares means|-0.51|STANDARD_ERROR_OF_MEAN|0.153||0.0008|TWO_SIDED|95.0|-0.81|-0.21|||Mixed Models Analysis|||||-0.21|-0.81|0.0008
70953304|NCT02187159|141408298|SUPERIORITY||Difference in least squares means|-0.07|STANDARD_ERROR_OF_MEAN|0.154||0.6464|TWO_SIDED|95.0|-0.37|0.23|||Mixed Models Analysis|||||0.23|-0.37|0.6464
70953305|NCT02187159|141408298|SUPERIORITY||Difference in least squares means|-0.03|STANDARD_ERROR_OF_MEAN|0.154||0.8543|TWO_SIDED|95.0|-0.33|0.27|||Mixed Models Analysis|||||0.27|-0.33|0.8543
70953306|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-0.6|STANDARD_ERROR_OF_MEAN|0.19||0.0014|TWO_SIDED|95.0|-1.0|0.2|||ANCOVA|||Worst pain: Placebo vs Pregabalin 150 mg BID||0.2|-1.0|0.0014
70953307|NCT02187159|141408300|SUPERIORITY||Difference of least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.1285|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Worst pain: Placebo vs DS-5565 15 mg QD||0.1|-0.7|0.1285
70953308|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.6595|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Worst pain: Placebo vs DS-5565 15 mg BID||0.3|-0.5|0.6595
70871084|NCT02197247|141227135|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|18.76|||||TWO_SIDED|90.0|16.61|21.19|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ5104 (metabolite), natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||21.19|16.61|
70871085|NCT02197247|141227135|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|90.08|||||TWO_SIDED|90.0|79.34|102.27|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ5104 (metabolite), natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||102.27|79.34|
70871086|NCT02197247|141227136|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|129.81|||||TWO_SIDED|90.0|119.14|141.44|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ7550 (metabolite), natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||141.44|119.14|
70871087|NCT02197247|141227136|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|100.76|||||TWO_SIDED|90.0|92.15|110.19|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ7550 (metabolite), natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||110.19|92.15|
70871088|NCT05673889|141227163|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|192.2|||||TWO_SIDED|90.0|166.56|221.79|||||The ratios (and 90% CIs) are expressed as percentages.|Dabigatran etexilate administered alone as Reference, ARV-471 coadministered with dabigatran etexilate as Test. Natural log transformed Cmax was analyzed using a mixed effect model with treatment as fixed effects and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||221.79|166.56|
70871089|NCT05673889|141227164|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|197.81|||||TWO_SIDED|90.0|177.32|220.66|||||The ratios (and 90% CIs) are expressed as percentages.|Dabigatran etexilate administered alone as Reference, ARV-471 coadministered with dabigatran etexilate as Test. Natural log transformed Cmax was analyzed using a mixed effect model with treatment as fixed effects and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||220.66|177.32|
70871090|NCT02228460|141227176|OTHER|||||||0.3173||||||Threshold for significance at 0.05 level.|McNemar Test|||A McNemar test was used to test the treatment effect based on paired pre-treatment and post-treatment (Week 26) frequencies of skin GL-3 score grouped into the categories (0 to \<2; 2 to 3).||||0.3173
70871091|NCT02228460|141227177|OTHER|||||||0.625||||||Threshold for significance at 0.05 level.|Wilcoxon signed rank test|||Wilcoxon signed rank test was used to assess the mean change from Baseline to Week 26 in skin GL-3 score.||||0.625
70871092|NCT03066804|141227207|SUPERIORITY||Geometric Mean Ratio|0.8362|||<|0.0001|TWO_SIDED|95.0|0.7987|0.8754|||Mixed Models Analysis|||Week 12||0.8754|0.7987|<0.0001
70871093|NCT03066804|141227208|SUPERIORITY||Mean Difference (Net)|-2.4985||||0.4164|TWO_SIDED|95.0|-8.5267|3.52297|||Mixed Models Analysis|||||3.52297|-8.5267|0.4164
70871094|NCT03066804|141227209|SUPERIORITY||Mean Difference (Net)|0.5231||||0.4791|TWO_SIDED|95.0|-0.9258|1.972|||Mixed Models Analysis|||||1.9720|-0.9258|0.4791
70871095|NCT03066804|141227210|SUPERIORITY||Odds Ratio (OR)|0.8993||||0.5294|TWO_SIDED|95.0|0.6461|1.2518|||longitudinal binary logistic regression|||||1.2518|0.6461|0.5294
70871096|NCT03066804|141227211|SUPERIORITY||Odds Ratio (OR)|1.106||||0.4938|TWO_SIDED|95.0|0.8287|1.476|||longitudinal binary logistic regression|||||1.4760|0.8287|0.4938
70871097|NCT03066804|141227212|SUPERIORITY||Odds Ratio (OR)|0.9798||||0.8314|TWO_SIDED|95.0|0.8122|1.182|||Proportional cumulative odds model|||||1.1820|0.8122|0.8314
70871098|NCT03066804|141227213|SUPERIORITY||Mean Difference (Net)|-0.157||||0.637||95.0|-0.8093|0.4953|||Mixed Models Analysis|||||0.4953|-0.8093|0.6370
70871099|NCT01930123|141227255|OTHER||Mean Difference (Final Values)|6.26|STANDARD_DEVIATION|9.98||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.01
70871100|NCT01930123|141227256|OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||Mild fibrosis vs. advanced fibrosis||||0.006
70871101|NCT01930123|141227257|OTHER||Median Difference (Final Values)|56.7|STANDARD_DEVIATION|2.6||0.09|TWO_SIDED||||||t-test, 1 sided|||||||0.09
70871102|NCT01447433|141227264|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.439|STANDARD_ERROR_OF_MEAN|0.56||0.441|TWO_SIDED|95.0|-0.7|1.58|||t-test, 2 sided|||||1.58|-0.70|0.441
70871103|NCT01447433|141227265|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.88|STANDARD_ERROR_OF_MEAN|0.41||0.038|TWO_SIDED|95.0|0.05|1.7|||t-test, 2 sided|||Body Fat Mass||1.70|0.05|0.038
70871104|NCT01447433|141227265|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.28||0.082|TWO_SIDED|95.0|-1.06|0.07|||t-test, 2 sided|||Body Lean Mass||0.07|-1.06|0.082
70871105|NCT01447433|141227265|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.07||0.018|TWO_SIDED|95.0|0.03|0.32|||t-test, 2 sided|||Visceral Fat Mass||0.32|0.03|0.018
70871106|NCT01447433|141227266|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|0.49||0.031|TWO_SIDED|95.0|0.1|2.09|||t-test, 2 sided|||||2.09|0.10|0.031
70871107|NCT01447433|141227267|SUPERIORITY_OR_OTHER||Median Difference (Net)|5.72|STANDARD_ERROR_OF_MEAN|2.25||0.016|TWO_SIDED|95.0|1.15|10.29|||t-test, 2 sided|||||10.29|1.15|0.016
70871108|NCT01447433|141227268|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.14|STANDARD_ERROR_OF_MEAN|1.7||0.508|TWO_SIDED|95.0|-2.31|4.58|||t-test, 2 sided|||Waist Circumference||4.58|-2.31|0.508
70871109|NCT01447433|141227268|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.22|STANDARD_ERROR_OF_MEAN|2.07||0.56|TWO_SIDED|95.0|-5.42|2.98|||t-test, 2 sided|||Abdominal Circumference||2.98|-5.42|0.560
70871110|NCT01447433|141227268|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.98|STANDARD_ERROR_OF_MEAN|0.85||0.255|TWO_SIDED|95.0|-0.74|2.7|||t-test, 2 sided|||Hip Circumference||2.70|-0.74|0.255
70953309|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.19||0.0938|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Worst pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.7|-0.1|0.0938
70953310|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0061|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Worst pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.9|0.1|0.0061
70953311|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0235|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|||Least pain: Placebo vs Pregabalin 150 mg BID||-0.1|-0.8|0.0235
70953312|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.3652|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Least pain: Placebo vs DS-5565 15 mg QD||0.2|-0.5|0.3652
70953313|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.6885|TWO_SIDED|95.0|-0.4|0.3|||ANCOVA|||Least pain: Placebo vs DS-5565 15 mg BID||0.3|-0.4|0.6885
70953314|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.18||0.1726|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Least pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.6|-0.1|0.1726
70953315|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.18||0.0627|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Least pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|-0.0|0.0627
70953316|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.16||0.0026|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|||Average pain: Placebo vs Pregabalin 150 mg BID||-0.2|-0.8|0.0026
70953317|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.1362|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||Average pain: Placebo vs DS-5565 15 mg QD||0.1|-0.6|0.1362
70953318|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.16||0.4344|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||Average pain: Placebo vs DS-5565 15 mg BID||0.2|-0.4|0.4344
70953319|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.16||0.1264|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Average pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.6|-0.1|0.1264
70871111|NCT01447433|141227269|SUPERIORITY_OR_OTHER||Median Difference (Net)|-3.8|STANDARD_ERROR_OF_MEAN|4.5||0.404|TWO_SIDED|95.0|-12.9|5.3|||t-test, 2 sided|||Systolic Blood Pressure||5.3|-12.9|0.404
70871112|NCT01447433|141227269|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.94|STANDARD_ERROR_OF_MEAN|3.18||0.768|TWO_SIDED|95.0|-5.52|7.41|||t-test, 2 sided|||Diastolic Blood Pressure||7.41|-5.52|0.768
70953320|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.16||0.026|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Average pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|0.0|0.0260
70953321|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0002|TWO_SIDED|95.0|-1.1|-0.4|||ANCOVA|||Pain right now: Placebo vs Pregabalin 150 mg BID||-0.4|-1.1|0.0002
70953322|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0597|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||Pain right now: Placebo vs DS-5565 15 mg QD||0.0|-0.8|0.0597
70953323|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1198|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Pain right now: Placebo vs DS-5565 15 mg BID||0.1|-0.7|0.1198
70953324|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-0.563|STANDARD_ERROR_OF_MEAN|0.1644||0.0006|TWO_SIDED|95.0|-0.885|-0.24|||ANCOVA|||Severity score: Placebo vs Pregabalin 150 mg BID||-0.240|-0.885|0.0006
70953325|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-0.261|STANDARD_ERROR_OF_MEAN|0.164||0.1118|TWO_SIDED|95.0|-0.583|0.061|||ANCOVA|||Severity score: Placebo vs DS-5565 15 mg QD||0.061|-0.583|0.1118
70953326|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-0.142|STANDARD_ERROR_OF_MEAN|0.1646||0.387|TWO_SIDED|95.0|-0.465|0.18|||ANCOVA|||Severity score: Placebo vs DS-5565 15 mg BID||0.180|-0.465|0.3870
70953327|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|0.302|STANDARD_ERROR_OF_MEAN|0.1642||0.0633|TWO_SIDED|95.0|-0.02|0.624|||ANCOVA|||Severity score: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.624|-0.020|0.0633
70953328|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|0.42|STANDARD_ERROR_OF_MEAN|0.1647||0.0108|TWO_SIDED|95.0|0.097|0.744|||ANCOVA|||Severity score: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.744|0.097|0.0108
70953329|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|7.5|STANDARD_ERROR_OF_MEAN|2.41||0.002|TWO_SIDED|95.0|2.7|12.2|||ANCOVA|||Relief by treatment of pain: Placebo vs Pregabalin 150 mg BID||12.2|2.7|0.0020
70953330|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|3.0|STANDARD_ERROR_OF_MEAN|2.41||0.2188|TWO_SIDED|95.0|-1.8|7.7|||ANCOVA|||Relief by treatment of pain: Placebo vs DS-5565 15 mg QD||7.7|-1.8|0.2188
70953331|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|4.0|STANDARD_ERROR_OF_MEAN|2.41||0.0991|TWO_SIDED|95.0|-0.8|8.7|||ANCOVA|||Relief by treatment of pain: Placebo vs DS-5565 15 mg BID||8.7|-0.8|0.0991
70953332|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-4.5|STANDARD_ERROR_OF_MEAN|2.41||0.0611|TWO_SIDED|95.0|-9.2|0.2|||ANCOVA|||Relief by treatment of pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.2|-9.2|0.0611
70953333|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-3.5|STANDARD_ERROR_OF_MEAN|2.41||0.1489|TWO_SIDED|95.0|-8.2|1.2|||ANCOVA|||Relief by treatment of pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||1.2|-8.2|0.1489
70953334|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-6.04|STANDARD_ERROR_OF_MEAN|1.751||0.0006|TWO_SIDED|95.0|-9.47|-2.6|||ANCOVA|||Interference: Placebo vs Pregabalin 150 mg BID||-2.60|-9.47|0.0006
70953335|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-4.09|STANDARD_ERROR_OF_MEAN|1.747||0.0193|TWO_SIDED|95.0|-7.52|-0.67|||ANCOVA|||Interference: Placebo vs DS-5565 15 mg QD||-0.67|-7.52|0.0193
70953336|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-1.64|STANDARD_ERROR_OF_MEAN|1.752||0.3506|TWO_SIDED|95.0|-5.07|1.8|||ANCOVA|||Interference: Placebo vs DS-5565 15 mg BID||1.80|-5.07|0.3506
70953337|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|1.94|STANDARD_ERROR_OF_MEAN|1.748||0.266|TWO_SIDED|95.0|-1.48|5.37|||ANCOVA|||Interference: Pregabalin 150 mg BID vs DS-5565 15 mg QD||5.37|-1.48|0.2660
70953338|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|4.4|STANDARD_ERROR_OF_MEAN|1.754||0.0122|TWO_SIDED|95.0|0.96|7.84|||ANCOVA|||Interference: Pregabalin 150 mg BID vs DS-5565 15 mg BID||7.84|0.96|0.0122
70953339|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.0119|TWO_SIDED|95.0|-0.9|-0.1|||ANCOVA|||General activity: Placebo vs Pregabalin 150 mg BID||-0.1|-0.9|0.0119
70953340|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0659|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||General activity: Placebo vs DS-5565 15 mg QD||0.0|-0.8|0.0659
70953341|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.5104|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||General activity: Placebo vs DS-5565 15 mg BID||0.3|-0.5|0.5104
70953342|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.4934|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||General activity: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.5|-0.3|0.4934
70953343|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0634|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||General activity: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.8|-0.0|0.0634
70953344|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-0.7|STANDARD_ERROR_OF_MEAN|0.21||0.0007|TWO_SIDED|95.0|-1.1|-0.3|||ANCOVA|||Mood: Placebo vs Pregabalin 150 mg BID||-0.3|-1.1|0.0007
70953345|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0837|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||Mood: Placebo vs DS-5565 15 mg QD||0.0|-0.8|0.0837
70953346|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.2379|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||Mood: Placebo vs DS-5565 15 mg BID||0.2|-0.7|0.2379
70953347|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.098|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Mood: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|-0.1|0.0980
71145234|NCT02016781|141784310|SUPERIORITY|||||||0.5942||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 PCS scores from enrollment are the same at 24 Months for both treatments.||||0.5942
70871113|NCT01447433|141227270|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.565|TWO_SIDED|95.0|-0.36|0.2|||t-test, 2 sided|||TC||0.20|-0.36|0.565
70953348|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0283|TWO_SIDED|95.0|0.0|0.9|||ANCOVA|||Mood: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.9|0.0|0.0283
70953349|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.2179|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||Walking ability: Placebo vs Pregabalin 150 mg BID||0.2|-0.7|0.2179
70953350|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.6683|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Walking ability: Placebo vs DS-5565 15 mg QD||0.3|-0.5|0.6683
70953351|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.2247|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Walking ability: Placebo vs DS-5565 15 mg BID||0.7|-0.2|0.2247
70953352|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.21||0.4198|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Walking ability: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.6|-0.2|0.4198
70953353|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0146|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Walking ability: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.9|0.1|0.0146
70953354|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0662|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||Normal work: Placebo vs Pregabalin 150 mg BID||0.0|-0.8|0.0662
70953355|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.2282|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||Normal work: Placebo vs DS-5565 15 mg QD||0.2|-0.7|0.2282
70953356|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.7336|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Normal work: Placebo vs DS-5565 15 mg BID||0.3|-0.5|0.7336
70953357|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.21||0.524|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Normal work: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.5|-0.3|0.5240
70953358|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1349|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Normal work: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|-0.1|0.1349
70953359|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0464|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||Relations with other people: Placebo vs Pregabalin 150 mg BID||-0.0|-0.8|0.0464
70953360|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.0975|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Relations with other people: Placebo vs DS-5565 15 mg QD||0.1|-0.7|0.0975
71145235|NCT02016781|141784310|SUPERIORITY|||||||0.1615||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 PCS scores from enrollment are the same at 36 Months for both treatments.||||0.1615
70953361|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.21||0.6088|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Relations with other people: Placebo vs DS-5565 15 mg BID||0.5|-0.3|0.6088
70953362|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.21||0.7341|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Relations with other people: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.5|-0.3|0.7341
70953363|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0125|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Relations with other people: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.9|0.1|0.0125
70953364|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-1.0|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.4|-0.5|||ANCOVA|||Sleep: Placebo vs Pregabalin 150 mg BID||-0.5|-1.4|<0.0001
70953365|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.23||0.0003|TWO_SIDED|95.0|-1.3|-0.4|||ANCOVA|||Sleep: Placebo vs DS-5565 15 mg QD||-0.4|-1.3|0.0003
70871114|NCT01447433|141227270|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.15||0.636|TWO_SIDED|95.0|-0.24|0.39|||t-test, 2 sided|||TG||0.39|-0.24|0.636
70871115|NCT01447433|141227270|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.16||0.112|TWO_SIDED|95.0|-0.58|0.06|||t-test, 2 sided|||HDL||0.06|-0.58|0.112
70871116|NCT01447433|141227270|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.15||0.647|TWO_SIDED|95.0|-0.11|0.05|||t-test, 2 sided|||LDL||0.05|-0.11|0.647
70871117|NCT01447433|141227271|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.11||0.26|TWO_SIDED|95.0|-0.1|0.35|||t-test, 2 sided|||||0.35|-0.10|0.260
70871118|NCT01447433|141227272|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.87|STANDARD_ERROR_OF_MEAN|1.63||0.598|TWO_SIDED|95.0|-2.44|4.17|||t-test, 2 sided|||||4.17|-2.44|0.598
70871119|NCT01447433|141227273|SUPERIORITY_OR_OTHER||Mean Difference (Net)|98.5|STANDARD_ERROR_OF_MEAN|89.0||0.275|TWO_SIDED|95.0|-81.6|278.7|||t-test, 2 sided|||||278.7|-81.6|0.275
70871120|NCT00036270|141227274|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.118|TWO_SIDED|95.0|0.77|1.03|||Log Rank|Log rank (Mantel-Cox). Adjusted for overall stratification factor; 1 degree of freedom.|A hazard ratio less than 1 favors the test treatment (exemestane only arm).|"Analysis at 2.75 years post-randomization. Null hypothesis: no difference in DFS between the two treatments for the first 2.75 years.~To maintain overall alpha of 0.05, 2 adjustments made: first, a nominal alpha of 0.0302 was used for the primary endpoint. Second, level of significant was 0.0012 for interim analysis."||1.03|0.77|0.118
70871121|NCT00036270|141227275|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.604|TWO_SIDED|95.0|0.88|1.08|||Log Rank|Log rank (Mantel-Cox). Adjusted for overall stratification factor; 1 degree of freedom.|A hazard ratio less than 1 favors the test treatment (exemestane only arm).|"Analysis at 5 years post-randomization. Null hypothesis: no difference in DFS between the two treatments for the first 5 years.~To maintain overall alpha of 0.05, a nominal alpha of 0.0302 was used."||1.08|0.88|0.604
70871122|NCT00036270|141227276|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.951|TWO_SIDED|95.0|0.89|1.14|||Log Rank|Log rank (Mantel-Cox). Adjusted for overall stratification factor; 1 degree of freedom.|A hazard ratio less than 1 favors the test treatment (exemestane only arm).|Analysis at 5 years post-randomization. Null hypothesis: no difference in OS between the two treatments for the first 5 years. Overall alpha of 0.05 was maintained.||1.14|0.89|0.951
70871123|NCT00036270|141227278|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.293|TWO_SIDED|95.0|0.83|1.06|||Log Rank|Log rank (Mantel-Cox). Adjusted for overall stratification factor; 1 degree of freedom.|A hazard ratio less than 1 favors the test treatment (exemestane only arm).|Analysis at 5 years post-randomization. Null hypothesis: no difference in time to relapse between the two treatments for the first 5 years. Overall alpha of 0.05 was maintained.||1.06|0.83|0.293
70871124|NCT01964430|141227282|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1824|TWO_SIDED|95.0|0.729|1.063|||Log Rank|Stratified by resection status (R0 versus R1) and nodal status (LN+ versus LN).|Estimated using stratified Cox proportional hazards model adjusting for strata of resection status (R0 versus R1) and nodal status (LN+ versus LN-).|||1.063|0.729|0.1824
70871125|NCT01964430|141227283|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0128|TWO_SIDED|95.0|0.691|0.957|||Log Rank|Stratified by resection status (R0 versus. R1) and nodal status (LN+ versus. LN-)|Estimated using stratified Cox proportional hazards model adjusting for strata of resection status (R0 versus R1) and nodal status (LN+ versus|||0.957|0.691|0.0128
70871126|NCT02446483|141227291|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established when 90% Confidence Interval falls within 80-125%.|Point Estimate Percent|101.32|||||TWO_SIDED|90.0|95.81|107.15||||||||107.15|95.81|
70871127|NCT02446483|141227292|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Point Estimate Percent|98.71|||||TWO_SIDED|90.0|92.54|105.28||||||Comparison of T- rabeprazole 20 mg and R- rabeprazole 20 mg for AUC0-t.||105.28|92.54|
70871128|NCT02446483|141227292|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Point Estimate Percent|98.05|||||TWO_SIDED|90.0|91.81|104.71||||||Comparison of Treatment A- rabeprazole 20 mg and Treatment B- rabeprazole 20 mg for AUC0-infinity.||104.71|91.81|
70871129|NCT02446483|141227293|SUPERIORITY_OR_OTHER|||||||0.0029||95.0|||||Wilcoxon's Signed-Rank Test|||||||0.0029
70871130|NCT00602797|141227328|OTHER|An interim analysis was conducted after 10 patients were accrued. Since response rate seen at the first interim analysis was superior to that seen with standard of care, a new monitoring rule was approved. Toxicity monitoring would occur after 19 patients. If 6/19 patients had ≥grade 4 non-hematological toxicity, accrual will be terminated. This will provide 84% power to detect 40% toxicity.|Proportion|6.0|||||TWO_SIDED||||||||If 6/19 patients had ≥grade 4 non-hematological toxicity, accrual will be terminated.|Adverse events will be graded using the NCI Common Toxicity Criteria (version 3.0).||||
70871131|NCT03473977|141227330|OTHER|||||||0.0001|||||||Fisher Exact|||||||0.0001
70871132|NCT03473977|141227331|OTHER|||||||0.75|||||||Kruskal-Wallis|||||||0.75
70871133|NCT03473977|141227332|OTHER|||||||0.006|||||||Kruskal-Wallis|||||||0.006
70871134|NCT03473977|141227333|OTHER|||||||0.004|||||||Kruskal-Wallis|||||||0.004
70871135|NCT03473977|141227334|OTHER|||||||0.0058|||||||t-test, 2 sided|||||||0.0058
70871136|NCT03473977|141227335|OTHER|||||||0.014|||||||Kruskal-Wallis|||||||0.014
70871137|NCT03473977|141227336|OTHER|||||||0.78|||||||Kruskal-Wallis|||Pain Score Comparison||||0.78
70871138|NCT03473977|141227336|OTHER|||||||0.34|||||||Kruskal-Wallis|||Non-pain score comparison||||0.34
70871139|NCT03473977|141227336|OTHER|||||||0.66|||||||Kruskal-Wallis|||Satisfaction score comparison||||0.66
70871140|NCT01558271|141227381|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.57|||<|0.001|TWO_SIDED|95.0|-1.79|-1.35|||Mixed Models Analysis|||Approximately 490 participants were to be randomized in a 4:1:2 ratio to LY2189265, placebo, or Liraglutide, respectively. This sample size would provide greater than 99% power to demonstrate superiority of LY2189265 to placebo. This computation assumed a true mean difference in HbA1c change from baseline between LY2189265 and placebo being 0.8%, a common standard deviation of 1.1%, a 1-sided significance level of 0.025, and a 9% drop-out rate between randomization and Week 26.||-1.35|-1.79|<0.001
70872260|NCT03782792|141229729|OTHER||Median Difference (Final Values)|-16.88|||||TWO_SIDED|95.0|-67.32|12.76|||||Median difference was calculated by modified Hodges-Lehmann method.|Any assessments after death, the use of escape medication (before or after Day 8), open label spesolimab on Day 8, or rescue medication with spesolimab after Day 8 and assigned with the worst possible outcomes in rank analysis. Missing data at Week 4 were imputed and handled via assessment of ranks.||12.76|-67.32|
71145236|NCT02016781|141784310|SUPERIORITY|||||||0.5659||||||Statistical significance was determined using a pre-specified threshold of 0.05.|t-test, 2 sided|||The null hypothesis is that the MOS SF-36 MCS scores are the same at Enrollment for both treatments.||||0.5659
70871141|NCT01558271|141227381|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 95% Confidence Interval (CI) was \<0.4%, then LY2189265 was declared non-inferior to Liraglutide. If the upper limit of the 95% CI was \<0.0%, then LY2189265 was declared superior to liraglutide.|LS Mean Difference|-0.1||||0.248|TWO_SIDED|95.0|-0.27|0.07|||Mixed Models Analysis|||Approximately 490 participants were to be randomized in a 4:1:2 ratio to LY2189265, placebo, or Liraglutide, respectively. This sample size would provide \>90% power to confirm non-inferiority of LY2189265 to liraglutide by a margin of 0.4%. This computation assumed a true mean difference in HbA1c change from baseline between LY2189265 and Liraglutide being 0%, a common standard deviation of 1.1%, a 1-sided significance level of 0.025, and a 9% drop-out rate between randomization and Week 26.||0.07|-0.27|0.248
70871142|NCT01558271|141227382|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.04|TWO_SIDED|95.0|-0.39|-0.01|||Mixed Models Analysis|||||-0.01|-0.39|0.040
70871143|NCT01558271|141227383|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Treatment comparison for HbA1c \<7% at 26 weeks between LY2189265 and placebo.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (\<25 / \>=25 kg/m\^2), and baseline HbA1c group.||||||<0.001
70871144|NCT01558271|141227383|SUPERIORITY_OR_OTHER|||||||0.608|TWO_SIDED|||||Treatment comparison for HbA1c \<7% at 26 weeks between LY2189265 and Liraglutide.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (\<25 / \>=25 kg/m\^2), and baseline HbA1c group.||||||0.608
70871145|NCT01558271|141227383|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Treatment comparison for HbA1c \<=6.5% at 26 weeks between LY2189265 and placebo.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (\<25 / \>=25 kg/m\^2), and baseline HbA1c group.||||||<0.001
70871146|NCT01558271|141227383|SUPERIORITY_OR_OTHER|||||||0.844|TWO_SIDED|||||Treatment comparison for HbA1c \<=6.5% at 26 weeks between LY2189265 and Liraglutide.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (\<25 / \>=25 kg/m\^2), and baseline HbA1c group.||||||0.844
70871147|NCT01558271|141227383|SUPERIORITY_OR_OTHER|||||||0.112|TWO_SIDED|||||Treatment comparison for HbA1c \<7% at 52 weeks between LY2189265 and Liraglutide.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (\<25 / \>=25 kg/m\^2), and baseline HbA1c group.||||||0.112
70871148|NCT01558271|141227383|SUPERIORITY_OR_OTHER|||||||0.103|TWO_SIDED|||||Treatment comparison for HbA1c \<=6.5% at 52 weeks between LY2189265 and Liraglutide.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (\<25 / \>=25 kg/m\^2), and baseline HbA1c group.||||||0.103
70871149|NCT01558271|141227384|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.21|||<|0.001|TWO_SIDED|95.0|-47.31|-33.11||Treatment comparison for FBG at 26 weeks between LY2189265 and placebo.|Mixed Models Analysis|||||-33.11|-47.31|<0.001
71145237|NCT02016781|141784310|SUPERIORITY|||||||0.8555||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 MCS scores from enrollment are the same at 6 Months for both treatments.||||0.8555
70871150|NCT01558271|141227384|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.835|TWO_SIDED|95.0|-4.82|5.96|||Mixed Models Analysis|Treatment comparison for FBG at 26 weeks between LY2189265 and Liraglutide.||||5.96|-4.82|0.835
70871151|NCT01558271|141227384|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.77||||0.553|TWO_SIDED|95.0|-7.65|4.1||Treatment comparison for FBG at 52 weeks between LY2189265 and Liraglutide.|Mixed Models Analysis|||||4.10|-7.65|0.553
70871152|NCT01558271|141227386|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61||||0.057|TWO_SIDED|95.0|-0.02|1.23|||Mixed Models Analysis|Treatment comparison for body weight at 26 weeks between LY2189265 and placebo.||||1.23|-0.02|0.057
70871153|NCT01558271|141227386|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34||||0.168|TWO_SIDED|95.0|-0.14|0.82||Treatment comparison for body weight at 26 weeks between LY2189265 and Liraglutide.|Mixed Models Analysis|||||0.82|-0.14|0.168
70871154|NCT01558271|141227386|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.911|TWO_SIDED|95.0|-0.64|0.57||Treatment comparison for body weight at 52 weeks between LY2189265 and Liraglutide.|Mixed Models Analysis|||||0.57|-0.64|0.911
70871155|NCT01558271|141227387|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.86||||0.723|TWO_SIDED|95.0|-12.2|8.48||Treatment comparison for HOMA2-%S based on fasting insulin at 26 weeks between LY2189265 and placebo.|ANCOVA|||||8.48|-12.20|0.723
70871156|NCT01558271|141227387|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01||||0.998|TWO_SIDED|95.0|-7.92|7.91||Treatment comparison for HOMA2-%S based on fasting insulin at 26 weeks between LY2189265 and Liraglutide.|ANCOVA|||||7.91|-7.92|0.998
70871157|NCT01558271|141227387|SUPERIORITY_OR_OTHER||LS Mean Difference|0.83||||0.848|TWO_SIDED|95.0|-7.72|9.38||Treatment comparison for HOMA2-%S based on fasting C-peptide at 26 weeks between LY2189265 and placebo.|ANCOVA|||||9.38|-7.72|0.848
70871158|NCT01558271|141227387|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.03||||0.357|TWO_SIDED|95.0|-9.48|3.42||Treatment comparison for HOMA2-%S based on fasting C-peptide at 26 weeks between LY2189265 and Liraglutide.|ANCOVA|||||3.42|-9.48|0.357
70871159|NCT01558271|141227387|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.49||||0.533|TWO_SIDED|95.0|-10.35|5.36||Treatment comparison for HOMA2-%S based on fasting insulin at 52 weeks between LY2189265 and Liraglutide.|ANCOVA|||||5.36|-10.35|0.533
70871160|NCT01558271|141227387|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.03||||0.747|TWO_SIDED|95.0|-7.32|5.25||Treatment comparison for HOMA2-%S based on fasting C-peptide at 52 weeks between LY2189265 and Liraglutide.|ANCOVA|||||5.25|-7.32|0.747
70871161|NCT01558271|141227388|SUPERIORITY_OR_OTHER||LS Mean Difference|28.35|||<|0.001|TWO_SIDED|95.0|21.63|35.07||Treatment comparison for HOMA2-%B based on fasting insulin at 26 weeks between LY2189265 and placebo.|ANCOVA|||||35.07|21.63|<0.001
70953366|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-0.7|STANDARD_ERROR_OF_MEAN|0.23||0.004|TWO_SIDED|95.0|-1.1|-0.2|||ANCOVA|||Sleep: Placebo vs DS-5565 15 mg BID||-0.2|-1.1|0.0040
70953367|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.23||0.5801|TWO_SIDED|95.0|-0.3|0.6|||ANCOVA|||Sleep: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.6|-0.3|0.5801
70953368|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.23||0.1869|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Sleep: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|-0.1|0.1869
70953369|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.22||0.0002|TWO_SIDED|95.0|-1.3|-0.4|||ANCOVA|||Enjoyment of life: Placebo vs Pregabalin 150 mg BID||-0.4|-1.3|0.0002
70953370|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0271|TWO_SIDED|95.0|-0.9|-0.1|||ANCOVA|||Enjoyment of life: Placebo vs DS-5565 15 mg QD||-0.1|-0.9|0.0271
70953371|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.1123|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||Enjoyment of life: Placebo vs DS-5565 15 mg BID||0.1|-0.8|0.1123
71145238|NCT02016781|141784310|SUPERIORITY|||||||0.8995||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 MCS scores from enrollment are the same at 12 Months for both treatments.||||0.8995
71145239|NCT02016781|141784310|SUPERIORITY|||||||0.0105||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 MCS scores from enrollment are the same at 18 Months for both treatments.||||0.0105
70871162|NCT01558271|141227388|SUPERIORITY_OR_OTHER||LS Mean Difference|3.08||||0.242|TWO_SIDED|95.0|-2.09|8.24||Treatment comparison for HOMA2-%B based on fasting insulin at 26 weeks between LY2189265 and Liraglutide.|ANCOVA|||||8.24|-2.09|0.242
70953372|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1183|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Enjoyment of life: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|-0.1|0.1183
70953373|NCT02187159|141408300|SUPERIORITY||Difference in least squares means|0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0299|TWO_SIDED|95.0|0.0|0.9|||ANCOVA|||Enjoyment of life: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.9|0.0|0.0299
70953374|NCT02187159|141408301|SUPERIORITY||Difference in least squares means|-0.015|STANDARD_ERROR_OF_MEAN|0.0249||0.5578|TWO_SIDED|95.0|-0.063|0.034|||ANCOVA|||||0.034|-0.063|0.5578
70953375|NCT02187159|141408301|SUPERIORITY||Difference in least squares means|-0.009|STANDARD_ERROR_OF_MEAN|0.0248||0.7034|TWO_SIDED|95.0|-0.058|0.039|||ANCOVA|||||0.039|-0.058|0.7034
70871163|NCT01558271|141227388|SUPERIORITY_OR_OTHER||LS Mean Difference|24.82|||<|0.001|TWO_SIDED|95.0|19.25|30.4||Treatment comparison for HOMA2-%B based on fasting C-peptide at 26 weeks between LY2189265 and placebo.|ANCOVA|||||30.40|19.25|<0.001
70953376|NCT02187159|141408301|SUPERIORITY||Difference in least squares means|-0.02|STANDARD_ERROR_OF_MEAN|0.0249||0.4143|TWO_SIDED|95.0|-0.069|0.028|||ANCOVA|||||0.028|-0.069|0.4143
70953377|NCT02187159|141408301|SUPERIORITY||Difference in least squares means|0.005|STANDARD_ERROR_OF_MEAN|0.0249||0.8365|TWO_SIDED|95.0|-0.044|0.054|||ANCOVA|||||0.054|-0.044|0.8365
70953378|NCT02187159|141408301|SUPERIORITY||Difference in least squares means|-0.006|STANDARD_ERROR_OF_MEAN|0.0249||0.8189|TWO_SIDED|95.0|-0.055|0.043|||ANCOVA|||||0.043|-0.055|0.8189
70953379|NCT00567567|141408302|SUPERIORITY_OR_OTHER_LEGACY||Log Rank Test Statistic|6.9883||||0.0082|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients randomized to Regimen A - Single HST (CEM) and randomized to Regimen B - Tandem HST (CEM) were compared using the log-rank test.||||0.0082
70953380|NCT00567567|141408303|SUPERIORITY_OR_OTHER_LEGACY||Chi-squared test statistic|8.5751||||0.0034|TWO_SIDED|95.0|||||Chi-squared|||Chi-square test of proportions in all patients to compare the proportion of responders (complete response \[CR\]+ very good partial response \[VGPR\]) at the end of induction therapy in this study to an analogous cohort of responders in A3973.||||0.0034
70953381|NCT00567567|141408304|SUPERIORITY_OR_OTHER_LEGACY||Gray's test statistic|0.33709||||0.5615|TWO_SIDED|95.0|||||Gray's test for competing risks|||The cumulative incidence rates of local recurrence between patients from ANBL0532 randomized or assigned to receive single CEM transplant and boost radiation and A3973 patients who were transplanted and received boost radiation were compared using Gray's test.||||0.5615
70953382|NCT00567567|141408305|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.0557||||0.0939|TWO_SIDED|95.0|||||Regression, Logistic|||||||0.0939
70953383|NCT00567567|141408306|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.0543||||0.3277|TWO_SIDED|95.0|||||Regression, Logistic|||||||0.3277
70953384|NCT00567567|141408307|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.4328||||0.7598|TWO_SIDED|95.0|0.4105|5.001|||Fisher Exact|Fisher's exact test was used instead of chi-square test due to small expected cell counts.||Null Hypothesis: The response rate after two cycles of induction therapy and the presence of a polymorphism are independent in the study population||5.001|0.4105|0.7598
71145240|NCT02016781|141784310|SUPERIORITY|||||||0.2596||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 MCS scores from enrollment are the same at 24 Months for both treatments.||||0.2596
71145241|NCT02016781|141784310|SUPERIORITY|||||||0.5022||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 MCS scores from enrollment are the same at 36 Months for both treatments.||||0.5022
71145242|NCT02016781|141784311|SUPERIORITY|||||||0.1768||||||Statistical significance was determined using a pre-specified threshold of 0.05.|t-test, 2 sided|||The null hypothesis is that the EQ-5D scores are the same at Enrollment for both treatments.||||0.1768
70953385|NCT00567567|141408311|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.015||||0.6853|TWO_SIDED|95.0|||||Regression, Cox|||The relationship between the peak serum isotretinoin concentration level with event-free survival was explored with a Cox proportional hazards model. Eligible patients treated with isotretinoin on A3973, ANBL0032, ANBL0532, or ANBL0931 with peak serum concentration level data were included in the analysis.||||0.6853
70953386|NCT02278484|141408350|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70953387|NCT01401153|141408352|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation based on parallel group design --\> revealed that 68 children are needed to detect a difference of 45ms in the mean reaction time between the groups, with α=.05 and a power of 0.8.||||||0.79|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||Power calculation had been performed.||||0.79
70953388|NCT01401153|141408353|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.07|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.07
70871164|NCT01558271|141227388|SUPERIORITY_OR_OTHER||LS Mean Difference|1.91||||0.376|TWO_SIDED|95.0|-2.32|6.13||Treatment comparison for HOMA2-%B based on fasting C-peptide at 26 weeks between LY2189265 and Liraglutide.|ANCOVA|||||6.13|-2.32|0.376
70953389|NCT01401153|141408354|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.61|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.61
70953390|NCT01401153|141408355|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been perfomed based on this measure||||||0.03|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.03
71145243|NCT02016781|141784311|SUPERIORITY|||||||0.8318||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in EQ-5D scores from enrollment are the same at 6 Months for both treatments.||||0.8318
71145244|NCT02016781|141784311|SUPERIORITY|||||||0.4752||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in EQ-5D scores from enrollment are the same at 12 Months for both treatments.||||0.4752
71145245|NCT02016781|141784311|SUPERIORITY|||||||0.5671||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in EQ-5D scores from enrollment are the same at 18 Months for both treatments.||||0.5671
70953391|NCT01401153|141408356|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.25|||||||Generalized linear models|The fixed statement considered treatment, test day and the interaction between treatment and test day||||||0.25
70871165|NCT01558271|141227388|SUPERIORITY_OR_OTHER||LS Mean Difference|1.91||||0.417|TWO_SIDED|95.0|-2.72|6.54||Treatment comparison for HOMA2-%B based on fasting insulin at 52 weeks between LY2189265 and Liraglutide.|ANCOVA|||||6.54|-2.72|0.417
70871166|NCT01558271|141227388|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73||||0.753|TWO_SIDED|95.0|-3.83|5.29||Treatment comparison for HOMA2-%B based on fasting C-peptide at 52 weeks between LY2189265 and Liraglutide.|ANCOVA|||||5.29|-3.83|0.753
70953392|NCT01401153|141408357|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.7|||||||Generalized linear models|||||||0.70
71145246|NCT02016781|141784311|SUPERIORITY|||||||0.3009||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in EQ-5D scores from enrollment are the same at 24 Months for both treatments.||||0.3009
71145247|NCT02016781|141784311|SUPERIORITY|||||||0.3403||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in EQ-5D scores from enrollment are the same at 36 Months for both treatments.||||0.3403
71145248|NCT02016781|141784312|SUPERIORITY||||||<|0.0001||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Wald test|||The null hypothesis is that the rates of three-year OS are the same for both treatments in treated population.||||< 0.0001
70871167|NCT01558271|141227389|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED|||||Treatment comparison at 26 weeks between LY2189265 and placebo.|Fisher Exact|||||||>0.999
70871168|NCT01558271|141227389|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED|||||Treatment comparison at 26 weeks between LY2189265 and Liraglutide.|Fisher Exact|||||||>0.999
70871169|NCT01558271|141227389|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED|||||Treatment comparison at 52 weeks between LY2189265 and Liraglutide.|Fisher Exact|||||||>0.999
70871170|NCT03547583|141227403|OTHER||Difference of LS-means|-0.52|||=|0.8008|TWO_SIDED|97.5|-5.17|4.13|||Mixed model repeated-measures|||The analysis of each imputed dataset will be performed using mixed-effects model for repeated measures (MMRM), including treatment, region, heart rhythm, study visit as fixed effects, interaction between study visit and treatment group, and adjustment for the baseline PLS values as covariates.||4.13|-5.17|= 0.8008
70871171|NCT03547583|141227403|OTHER||Difference of LS-means|-1.46|||=|0.4722|TWO_SIDED|97.5|-6.02|3.1|||Mixed model repeated-measures|||The analysis of each imputed dataset will be performed using mixed-effects model for repeated measures (MMRM), including treatment, region, heart rhythm, study visit as fixed effects, interaction between study visit and treatment group, and adjustment for the baseline PLS values as covariates.||3.10|-6.02|= 0.4722
70871172|NCT03547583|141227404|OTHER||Difference of LS-means|-1.81|||=|0.8054|TWO_SIDED|97.5|-18.3|14.67|||Mixed model repeated-measures|||The analysis of each imputed dataset will be performed using mixed-effects model for repeated measures (MMRM), including treatment, region, heart rhythm, study visit as fixed effects, interaction between study visit and treatment group, and adjustment for the baseline 6MWT values as covariates.||14.67|-18.30|= 0.8054
70871173|NCT03547583|141227404|OTHER||Difference of LS-means|-5.49|||=|0.4502|TWO_SIDED|97.5|-21.77|10.8|||mixed model repeated measures|||The analysis of each imputed dataset will be performed using mixed-effects model for repeated measures (MMRM), including treatment, region, heart rhythm, study visit as fixed effects, interaction between study visit and treatment group, and adjustment for the baseline 6MWT values as covariates.||10.80|-21.77|= 0.4502
70871174|NCT02657915|141227406|SUPERIORITY||Mean Difference (Final Values)|-6.0|||=|0.165|TWO_SIDED|95.0|-14.56|2.57|||ANCOVA|||||2.57|-14.56|=0.165
70871175|NCT03003390|141227433|SUPERIORITY||Posterior probabilities|0.09|||||TWO_SIDED||||||||||Using informative priors of B(1, 1) on the enoxaparin arm and B(18, 82) on the usual care arm, the risks of CADVT were 0.32 (95% CrI: 0.16, 0.51) in the enoxaparin arm and 0.25 (95% CrI: 0.18, 0.33) in the usual care arm. The posterior probability that the absolute difference in the risk of CADVT was lower by 0.06 in the enoxaparin arm was 9.1%. Using minimally informative priors, the risk ratio of CADVT with enoxaparin was 0.55 (95% CrI: 0.24, 1.11).|||
70871176|NCT03003390|141227434|SUPERIORITY|||||||0.22|||||||Linear mixed effects model|||||||0.22
70953393|NCT01401153|141408358|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.33|||||||Generalized linear models|||||||0.33
70953394|NCT01401153|141408359|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.63|||||||Generalized linear models|||||||0.63
70871177|NCT03003390|141227435|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
70871178|NCT03003390|141227436|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
70871179|NCT03003390|141227437|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||||||0.58
70871180|NCT03003390|141227438|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
70871181|NCT03003390|141227440|SUPERIORITY|||||||0.43|||||||Fisher Exact|||||||0.43
70871182|NCT02370160|141227469|OTHER||||||||||||||||||In Phase I: There were 9 subjects treated on dose level 1 (60 µg/kg/dose). There were 6 subjects treated on Dose level 2 (80 µg/kg/dose). There were four DLT events happened in Phase I. One was treated on dose level 1 and the other three were treated on dose level 2. Therefore the MTD was dose level 1.|||
70871183|NCT04487730|141227476|SUPERIORITY||Mean Difference (Final Values)|0.4727||||0.6249|TWO_SIDED||||||Mixed Models Analysis|||Functional connectivity within the orbital prefrontal cortex (OFC; specifically between lateral and medial OFC), significantly changed over time.||||0.6249
70871184|NCT04487730|141227477|SUPERIORITY||Mean Difference (Final Values)|3.8176||||0.525|TWO_SIDED||||||Mixed Models Analysis|||"Mixed effects model with a fixed effect for treatment and time, as well as time by treatment interaction, and a random effect for subject level.~F value for time by treatment interaction."||||.525
70871185|NCT04487730|141227478|SUPERIORITY||Mean Difference (Final Values)|0.6503||||0.844|TWO_SIDED||||||Mixed Models Analysis|||"Mixed effects model with a fixed effect for treatment and time, as well as time by treatment interaction, and a random effect for subject level.~F value for time by treatment interaction."||||.844
70871186|NCT01581931|141227479|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin: the 90% confidence intervall has to be within the intervall (80%, 125%)|Adjusted geometric mean ratio|97.69|STANDARD_DEVIATION|9.7|||TWO_SIDED|95.0|93.63|101.94|||ANOVA||Numerator: FDC tablet; denominator: single tablets of linagliptin and metformin; The dispersion parameter is actually the geometric coefficient of variation.|||101.94|93.63|
70871187|NCT01581931|141227482|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin: the 90% confidence intervall has to be within the intervall (80%, 125%)|Adjusted geometric mean ratio|97.76|STANDARD_DEVIATION|9.8|||TWO_SIDED|90.0|93.64|102.07|||ANOVA||Numerator: FDC tablet; denominator: single tablets of linagliptin and metformin; The dispersion parameter is actually the geometric coefficient of variation.|||102.07|93.64|
70871188|NCT01581931|141227483|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin: the 90% confidence intervall has to be within the intervall (80%, 125%)|Adjusted geometric mean ratio|98.79|STANDARD_DEVIATION|10.0|||TWO_SIDED|90.0|94.55|103.21|||ANOVA||Numerator: FDC tablet; denominator: single tablets of linagliptin and metformin; The dispersion parameter is actually the geometric coefficient of variation.|||103.21|94.55|
70871189|NCT03291808|141227496|OTHER|||||||0.35|||||||Kruskal-Wallis|||||||.35
70871190|NCT04666051|141227518|SUPERIORITY|Data from both groups has been collected compared to verify significant statistical difference||||||0.022|||||||Chi-squared|||||||0.022
70953395|NCT01401153|141408360|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.62|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.62
70953396|NCT01401153|141408361|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.11|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.11
70953397|NCT01401153|141408362|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.45|||||||t-test, 2 sided|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.45
70953398|NCT01401153|141408363|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.13|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.13
71145249|NCT02016781|141784313|SUPERIORITY||||||<|0.0001||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Wald test|||The null hypothesis is that the rates of three-year LFS are the same for both treatments in treated population.||||< 0.0001
70871191|NCT01651195|141227519|SUPERIORITY|We estimated that, with a power of 85% and at a significance level of 0.05 (Power 0.85, ß=0.14990 and α=0.05), we needed 467 conscripts per group to show a 17% difference between the groups. Each conscript was randomly allocated to the probiotic or the control group according to a computer generated, 8-blocked randomization list.|||||<|0.05|||||||Fisher Exact||||"Result variables were analyzed according to intention to treat (ITT) principle. Missing data was handled by statistic modeling. Data on symptom diaries were calculated as follows: the incidence and duration of individual infection symptoms and respiratory episodes were analyzed between the intervention groups using time to event analysis (cox model for hazard) and duration analysis (gamma regression model). The results are expressed as a hazard ratio (incidence rate ratio) of symptoms and the mean duration of symptoms (days) with 95% confidence intervals or standard deviations. The sums of respiratory and gastrointestinal symptoms were calculated with gamma regression analysis."|||< 0.05
70871192|NCT01651195|141227520|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||< 0.05
70871193|NCT01651195|141227521|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||< 0.05
70871194|NCT01651195|141227522|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||< 0.05
70871195|NCT01397084|141227556|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilocoxon signed-rank test|||Wilcoxon signed-rank test was used to check whether the change in the frequency of heartburn during the 7-day period prior to the 8 week visit (Visit 3) compared to the frequency of heartburn during the 7-day period prior to baseline (Visit 1) was statistically significant or not.||||<0.001
70871196|NCT02139228|141227560|SUPERIORITY_OR_OTHER||Vaccine Group Ratios|0.53|||||TWO_SIDED|95.0|0.36|0.76|||ANOVA|||||0.76|0.36|
70871197|NCT02139228|141227561|SUPERIORITY_OR_OTHER||Vaccine Group Differences|-11.0|||||TWO_SIDED|95.0|-18.6|-4.2|||Clopper-Pearson|||||-4.2|-18.6|
70871198|NCT00618072|141227562|SUPERIORITY_OR_OTHER|||||||0.181|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.181
70871199|NCT00618072|141227562|SUPERIORITY_OR_OTHER|||||||0.026|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.026
70871200|NCT00618072|141227562|SUPERIORITY_OR_OTHER|||||||0.063|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.063
70871201|NCT00618072|141227563|SUPERIORITY_OR_OTHER|||||||0.049|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.049
70871202|NCT00618072|141227563|SUPERIORITY_OR_OTHER|||||||0.002|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.002
70871203|NCT00618072|141227563|SUPERIORITY_OR_OTHER|||||||0.032|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.032
70871204|NCT00618072|141227564|SUPERIORITY_OR_OTHER|||||||0.142|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.142
70871205|NCT00618072|141227564|SUPERIORITY_OR_OTHER|||||||0.054|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.054
70871206|NCT00618072|141227564|SUPERIORITY_OR_OTHER|||||||0.013|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.013
70871207|NCT00618072|141227565|SUPERIORITY_OR_OTHER|||||||0.052|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.052
70871208|NCT00618072|141227565|SUPERIORITY_OR_OTHER|||||||0.143|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.143
70871209|NCT00618072|141227565|SUPERIORITY_OR_OTHER|||||||0.005|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.005
70871210|NCT00618072|141227566|SUPERIORITY_OR_OTHER|||||||0.265|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.265
70871211|NCT00618072|141227566|SUPERIORITY_OR_OTHER|||||||0.001|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.001
70871212|NCT00618072|141227566|SUPERIORITY_OR_OTHER|||||||0.389|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.389
70871213|NCT00618072|141227567|SUPERIORITY_OR_OTHER|||||||0.025|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.025
70871214|NCT00618072|141227567|SUPERIORITY_OR_OTHER|||||||0.162|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.162
70871215|NCT00618072|141227567|SUPERIORITY_OR_OTHER|||||||0.562|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.562
71145250|NCT03563209|141784331|OTHER||||||<|0.001||||||p-value was adjusted for multiple comparisons. A priori threshold for statistical significance was set to 0.05/3 (0.0167)|Friedman|||Null hypothesis: no difference between dynamic components of elbow flexor spasticity (spasticity angle) in three different forearm positions. (Comparison groups were Spasticity angle in pronation, Spasticity angle in neutral position and Spasticity angle in supination)||||<0.001
70953399|NCT01401153|141408364|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.68|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.68
70953400|NCT01401153|141408365|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.67|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.67
71145251|NCT02443688|141784386|OTHER|Single Group Difference from Placebo Mean Change from Baseline with 95% confidence interval (CI)|Mean Difference (Final Values)|1.39|STANDARD_ERROR_OF_MEAN|1.38|||TWO_SIDED|95.0|-1.34|4.12|||ANOVA|||||4.12|-1.34|
71145252|NCT02443688|141784386|OTHER|Single Group Difference from Placebo Mean Change from Baseline with 95% CI|Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|95.0|-3.78|1.64|||ANOVA|||||1.64|-3.78|
71145253|NCT02443688|141784386|SUPERIORITY|Difference from placebo of pooled arms (100mg CTX-4430 and 50mg CTX-4430) in change from baseline in ppFEV1 at Week 48.|Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|1.2||0.45|TWO_SIDED|95.0|-2.2|2.5||0.1 alpha level (2-sided) prespecified|ANOVA|||||2.50|-2.20|0.45
71145254|NCT02443688|141784387|OTHER|Single Group Rate with 95% CI|see Estimation Comment below|1.57|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|1.22|2.02|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||2.02|1.22|
71145255|NCT02443688|141784387|OTHER|Single Group Rate with 95% CI|see Estimation Comment below|1.46|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|1.13|1.89|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||1.89|1.13|
70953401|NCT00403767|141408376|NON_INFERIORITY_OR_EQUIVALENCE|Alternative hypothesis of non-inferiority (NI) by a NI margin of 1.46 in hazard ratio (HR) based on on-treatment data from the per protocol population. The required number of primary efficacy endpoint events was determined based on the following assumptions: NI margin of 1.46, 1-sided alpha of 0.025, power of \>95% when true HR is 1, and exponential distributions. The margin was selected based on clinical appropriateness and quantitative analysis of relevant studies in Hart et al.|Hazard Ratio (HR)|0.79|||<|0.001|TWO_SIDED|95.0|0.66|0.96||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.025 (1-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||||0.96|0.66|<0.001
70953402|NCT00403767|141408377|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.015|TWO_SIDED|95.0|0.65|0.95||The p-value Is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||0.95|0.65|0.015
70953403|NCT00403767|141408378|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.442|TWO_SIDED|95.0|0.96|1.11||The p-value is not adjusted for mulitple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as a covariate||Alternate hypothesis of superiority based on on-treatment data from the safety population.||1.11|0.96|0.442
70953404|NCT00403767|141408379|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.034|TWO_SIDED|95.0|0.74|0.99||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||0.99|0.74|0.034
70953405|NCT00403767|141408380|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.01|TWO_SIDED|95.0|0.74|0.96||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||0.96|0.74|0.010
70953406|NCT00403767|141408381|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.092|TWO_SIDED|95.0|0.7|1.03||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as a covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||1.03|0.70|0.092
70953407|NCT00403767|141408382|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.23||||0.003|TWO_SIDED|95.0|0.09|0.61||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||0.61|0.09|0.003
70953408|NCT00403767|141408383|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.121|TWO_SIDED|95.0|0.63|1.06||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as a covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||1.06|0.63|0.121
70953409|NCT00403767|141408384|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.289|TWO_SIDED|95.0|0.73|1.1||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as a covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||1.10|0.73|0.289
70953410|NCT00403767|141408385|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.073|TWO_SIDED|95.0|0.7|1.02||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||1.02|0.70|0.073
70953411|NCT00368927|141408433|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Fisher Exact|||With a sample size of 60 evaluable participants per intervention arm, we would have 90% power to detect a bronchial dysplasia response rate of 54% and 82% power to detect a bronchial dysplasia response rate of\> 51% among participants assigned to receive active sulindac (2-sided chi-square test with continuity correction; alpha=0.05).||||0.85
70953412|NCT00368927|141408434|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||t-test, 2 sided|||A sample size of 60 participants per intervention arm would provide 90% power and 80% power to detect effect sizes of 60% and 52%, respectively, using a two-sample t-test(alpha=0.05).||||0.63
70953413|NCT02229851|141408465|SUPERIORITY||Treatment difference|-1.53|||=|0.009|TWO_SIDED|95.0|-2.68|-0.38|||ANCOVA||Somapacitan-Placebo|Changes in truncal fat percentage from baseline to the 34 week's measurements was analysed using an analysis of covariance model with treatment, growth hormone deficiency (GHD) onset type, sex, region, diabetes mellitus (DM) and sex by region by DM interaction as factors and baseline as a covariate. The analysis was conducted using a multiple imputation technique where trajectory after a withdrawn subjects last observation was imputed based on data from the placebo arm.||-0.38|-2.68|=0.0090
70953414|NCT02206061|141408604|OTHER|Repeated measure analyses testing the overall treatment effect were performed by fitting the Generalized Estimating Equation (GEE) with SFD at the three follow-up time points (3, 5, 7 months) as the dependent variable and treatment as independent variable. Normal error and identity link was specified and standard error was calculated using Sandwich estimator. Baseline SFDs, poverty level, and the presence of smokers in the home were controlled in the regression model.|Mean Difference (Net)|0.9|STANDARD_DEVIATION|2.6|<|0.05|TWO_SIDED||||||Regression, Linear|||||||<.05
70871216|NCT00618072|141227568|SUPERIORITY_OR_OTHER|||||||0.016|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.016
70953415|NCT01607476|141408606|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70953416|NCT01607476|141408606|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71145256|NCT02443688|141784387|OTHER|Single Group Rate with 95% CI|see Estimation Comment below|1.56|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|1.21|2.01|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||2.01|1.21|
70953417|NCT01607476|141408606|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70953418|NCT01607476|141408607|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70953419|NCT01607476|141408607|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70953420|NCT01607476|141408607|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70953421|NCT02193490|141408624|OTHER|||||||0.001|||||||Kruskal-Wallis|||||||0.001
70953422|NCT02193490|141408625|OTHER|||||||0.078|||||||Kruskal-Wallis|||||||0.078
70953423|NCT02193490|141408626|OTHER||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
70953424|NCT02299414|141408627|SUPERIORITY||Risk Ratio (RR)|0.82|||<|0.001|TWO_SIDED|95.0|0.73|0.92|||Chi-squared|||||.92|.73|<0.001
70953425|NCT02299414|141408627|SUPERIORITY||Risk Ratio (RR)|0.8|||||TWO_SIDED|95.0|0.7|0.9||||||||.90|.70|
70953426|NCT02299414|141408627|SUPERIORITY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.6|0.89||||||||.89|.60|
70953427|NCT02299414|141408627|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.49|1.64||||||||1.64|.49|
70953428|NCT02299414|141408627|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.54|1.21||||||||1.21|.54|
70953429|NCT02299414|141408628|SUPERIORITY||Risk Ratio (RR)|1.07||||0.56|TWO_SIDED|95.0|0.85|1.36|||Chi-squared|||||1.36|0.85|0.56
70953430|NCT02299414|141408629|SUPERIORITY||Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.45|1.26||||||||1.26|.45|
70953431|NCT02299414|141408630|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.77|0.91||||||||0.91|0.77|
70953432|NCT02299414|141408631|SUPERIORITY||Risk Ratio (RR)|0.87|||||TWO_SIDED|95.0|0.77|0.99||||||||.99|.77|
70953433|NCT02299414|141408632|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.45|1.3||||||||1.3|.45|
70953434|NCT02299414|141408633|SUPERIORITY||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.98|1.18||||||||1.18|.98|
70953435|NCT02299414|141408634|SUPERIORITY||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.69|0.89||||||||.89|.69|
70953436|NCT02299414|141408635|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.68|1.04||||||||1.04|0.68|
70953437|NCT02299414|141408636|SUPERIORITY||Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.74|0.9||||||||.90|.74|
70953438|NCT02299414|141408637|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.93|1.1||||||||1.10|.93|
70953439|NCT02299414|141408638|SUPERIORITY||Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.59|1.27||||||||1.27|.59|
70953440|NCT02299414|141408639|SUPERIORITY||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.81|1.02||||||||1.02|.81|
70953441|NCT02299414|141408640|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.71|0.97||||||||.97|.71|
70953442|NCT02299414|141408641|SUPERIORITY||Mean Difference (Final Values)|0.16|||||TWO_SIDED|95.0|-0.11|0.43||||||||0.43|-0.11|
70953443|NCT02299414|141408642|SUPERIORITY||Mean Difference (Final Values)|0.31|||||TWO_SIDED|95.0|0.05|0.56||||||||0.56|0.05|
70953444|NCT02299414|141408643|SUPERIORITY||Mean Difference (Final Values)|1.7|||||TWO_SIDED|95.0|-17.6|20.9||||||||20.9|-17.6|
70953445|NCT02299414|141408644|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.81|1.17||||||||1.17|.81|
70953446|NCT02299414|141408645|SUPERIORITY||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.55|1.42||||||||1.42|.55|
70953447|NCT02299414|141408646|SUPERIORITY||Risk Ratio (RR)|0.43|||||TWO_SIDED|95.0|0.18|1.05||||||||1.05|.18|
70953448|NCT02299414|141408647|SUPERIORITY||Risk Ratio (RR)|0.87|||||TWO_SIDED|95.0|0.71|1.06||||||||1.06|.71|
70953449|NCT02299414|141408648|SUPERIORITY||Risk Ratio (RR)|0.57|||||TWO_SIDED|95.0|0.24|1.35||||||||1.35|.24|
70953450|NCT02299414|141408649|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.85|1.12||||||||1.12|.85|
70953451|NCT02299414|141408650|SUPERIORITY||Risk Ratio (RR)|0.64|||||TWO_SIDED|95.0|0.3|1.37||||||||1.37|0.30|
70953452|NCT02299414|141408651|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.14|7.06||||||||7.06|.14|
70953453|NCT02299414|141408652|SUPERIORITY||Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.81|1.08||||||||1.08|.81|
70953454|NCT02299414|141408653|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.62|1.16||||||||1.16|0.62|
70953455|NCT02299414|141408654|SUPERIORITY||Risk Ratio (RR)|0.61|||||TWO_SIDED|95.0|0.36|1.05||||||||1.05|.36|
70953456|NCT02299414|141408655|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.2|0.03||||||||0.03|-0.2|
70953457|NCT02299414|141408656|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.1|0.1||||||||0.1|-0.1|
70953458|NCT02299414|141408657|SUPERIORITY||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|95.0|-0.12|0.002||||||||0.002|-0.12|
70953459|NCT02299414|141408658|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.02|0.04||||||||0.04|-0.02|
70953460|NCT02299414|141408659|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.9|1.06||||||||1.06|0.90|
70953461|NCT02628028|141408679|SUPERIORITY|||||||0.473|||||||Regression, Logistic|||||||0.473
70953462|NCT02628028|141408679|SUPERIORITY|||||||0.67|||||||Regression, Logistic|||||||0.670
70953463|NCT02628028|141408679|SUPERIORITY|||||||0.823|||||||Regression, Logistic|||||||0.823
70953464|NCT02628028|141408680|SUPERIORITY|||||||0.743|||||||Regression, Logistic|||||||0.743
70953465|NCT02628028|141408680|SUPERIORITY|||||||0.124|||||||Regression, Logistic|||||||0.124
70953466|NCT02628028|141408680|SUPERIORITY|||||||0.858|||||||Regression, Logistic|||||||0.858
70953467|NCT02628028|141408681|SUPERIORITY|||||||0.199|||||||Regression, Logistic|||||||0.199
70953468|NCT02628028|141408681|SUPERIORITY|||||||0.028|||||||Regression, Logistic|||||||0.028
70953469|NCT02628028|141408681|SUPERIORITY|||||||0.863|||||||Regression, Logistic|||||||0.863
70953470|NCT02628028|141408682|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.25||0.863|TWO_SIDED|95.0|-0.53|0.44|||Mixed-effects Model for Repeated Measure|||||0.44|-0.53|0.863
70953471|NCT02628028|141408682|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.25||0.503|TWO_SIDED|95.0|-0.32|0.65|||Mixed-effects Model for Repeated Measure|||||0.65|-0.32|0.503
70953472|NCT02628028|141408682|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.25||0.289|TWO_SIDED|95.0|-0.77|0.23|||Mixed-effects Model for Repeated Measure|||||0.23|-0.77|0.289
70953473|NCT02628028|141408683|SUPERIORITY|||||||0.626|||||||Regression, Logistic|||||||0.626
70953474|NCT02628028|141408683|SUPERIORITY|||||||0.418|||||||Regression, Logistic|||||||0.418
70953475|NCT02628028|141408683|SUPERIORITY|||||||0.951|||||||Regression, Logistic|||||||0.951
70953476|NCT02628028|141408684|SUPERIORITY|||||||0.905|||||||Regression, Logistic|||||||0.905
70953477|NCT02628028|141408684|SUPERIORITY|||||||0.069|||||||Regression, Logistic|||||||0.069
70953478|NCT02628028|141408684|SUPERIORITY|||||||0.547|||||||Regression, Logistic|||||||0.547
70953479|NCT04157400|141408686|OTHER||||||<|0.01|||||||Kruskal-Wallis|||||||<0.01
70953480|NCT04157400|141408687|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
70953481|NCT04157400|141408688|OTHER||||||||||||||||||Segments of EMG recorded during walking at self-selected walking speed were used to investigate complexity of muscle synergies using a nonnegative matrix factorization (NNMF) algorithm (MATLAB®, Mathworks, Natick, MA). The approach involves calculation of an mxt matrix of the original EMG data (EMG0), where m represents the number of muscles being measured and t represents a time base normalized to percentage of gait cycle. The algorithm also calculates two surrogate matrices, mxn and nxt, where n is the amplitude of muscle activation. The product of the surrogate matrices are considered a reconstruction of EMG (EMGr). EMGr for each module is then compared to EMG0 by finding the variability accounted for (VAF). A threshold necessary for module classification was chosen to be 90% for all conditions (8 muscles + 6 phases of gait) based on similar studies in the literature. Classifications were not increased unless the higher module VAF was at least 5% higher than the preceding module.|||
70953482|NCT00186888|141408701|SUPERIORITY_OR_OTHER_LEGACY||Binomial Proportion|88.9|||||TWO_SIDED|95.0|71.3|96.9||||||||96.9|71.3|
70953483|NCT00186888|141408702|SUPERIORITY_OR_OTHER_LEGACY||Binomial Proportion|91.7|||||TWO_SIDED|95.0|65.1|99.6||||||||99.6|65.1|
70953484|NCT00186888|141408703|SUPERIORITY_OR_OTHER_LEGACY|||||||0.452||95.0|||||ANOVA|||CYP3A4\*1B: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.452
70953485|NCT00186888|141408703|SUPERIORITY_OR_OTHER_LEGACY|||||||0.106||95.0|||||ANOVA|||CYP3A5\*3: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.106
70953486|NCT00186888|141408704|SUPERIORITY_OR_OTHER_LEGACY|||||||0.245||95.0|||||ANOVA|||BCRP 1143: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.245
70953487|NCT00186888|141408704|SUPERIORITY_OR_OTHER_LEGACY|||||||0.297||95.0|||||ANOVA|||BCRP 15622: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.297
70953488|NCT00186888|141408704|SUPERIORITY_OR_OTHER_LEGACY|||||||0.372||95.0|||||ANOVA|||BCRP Exon 2: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.372
70953489|NCT00186888|141408704|SUPERIORITY_OR_OTHER_LEGACY|||||||0.844||95.0|||||ANOVA|||BCRP Exon 5: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.844
70953490|NCT00186888|141408704|SUPERIORITY_OR_OTHER_LEGACY|||||||0.616||95.0|||||ANOVA|||Pgp Exon 21: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.616
70953491|NCT00186888|141408704|SUPERIORITY_OR_OTHER_LEGACY|||||||0.424||95.0|||||ANOVA|||Pgp Exon 26: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.424
70953492|NCT04711837|141408755|NON_INFERIORITY|Non-inferiority margin equals to -8%|Risk Difference (RD)|-0.0057|STANDARD_ERROR_OF_MEAN|0.0246|||TWO_SIDED|95.0|-0.054|0.042||Non-inferiority margin equals to -8%: 95% CI; (-5.4%, 4.2%)|Farrington-Manning method|||||0.042|-0.054|
70953493|NCT02344290|141408763|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.48|0.84|||||Hazard ratio is shown as pitavastatin/placebo. Two-sided 95% repeated confidence interval that adjusts for interim looks according to the realized Lan and DeMets implementation of the O'Brien-Fleming sequential stopping boundary is presented.|||0.84|0.48|
71145257|NCT02443688|141784387|OTHER|Pooled Group Rate with 95% CI|see Estimation Comment below|1.51|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|1.26|1.81|||||Estimated using negative binomial distribution unadjusted for multiple comparisons.|||1.81|1.26|
70953494|NCT02344290|141408764|SUPERIORITY||Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.36|0.87|||||Hazard ratio is shown as pitavastatin/placebo.|||0.87|0.36|
70953495|NCT02344290|141408765|SUPERIORITY||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.4|0.97|||||Hazard ratio is shown as pitavastatin/placebo.|||0.97|0.40|
70953496|NCT02344290|141408766|SUPERIORITY||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.11|4.02|||||Hazard ratio is shown as pitavastatin/placebo.|||4.02|0.11|
70953497|NCT02344290|141408767|SUPERIORITY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.35|1.38|||||Hazard ratio is shown as pitavastatin/placebo.|||1.38|0.35|
70953498|NCT02344290|141408768|SUPERIORITY||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.44|1.03|||||Hazard ratio is shown as pitavastatin/placebo.|||1.03|0.44|
71145258|NCT02443688|141784388|OTHER|95% 2-sided confidence interval for the Hazard Ratio relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.88|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|0.58|1.34|||Regression, Cox|||||1.34|0.58|
71145259|NCT02443688|141784388|OTHER|95% 2-sided confidence interval for the Hazard Ratio relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.86|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|0.56|1.31|||Regression, Cox|||||1.31|0.56|
70953499|NCT02344290|141408769|SUPERIORITY||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.36|1.05|||||||Hazard ratio is shown as pitavastatin/placebo.|1.05|0.36|
70953500|NCT02344290|141408771|SUPERIORITY||Hazard Ratio (HR)|0.0|||||TWO_SIDED|95.0|0.0|0.54|||||||Hazard ratio is shown as pitavastatin/placebo. Estimation of the confidence interval used a Bayes analysis with a non-informative prior using adaptive rejection Metropolis sampling. In this case, the interval shown is a 95% highest posterior density (HPD) interval.|0.54|0.00|
70953501|NCT02344290|141408772|SUPERIORITY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.64|0.94|||||Hazard ratio is shown as pitavastatin/placebo.|||0.94|0.64|
70953502|NCT02344290|141408773|SUPERIORITY||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.7|1.12|||||Hazard ratio is shown as pitavastatin/placebo.|||1.12|0.70|
70953503|NCT02344290|141408774|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.76|1.13|||||Hazard ratio is shown as pitavastatin/placebo.|||1.13|0.76|
70953504|NCT02344290|141408775|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.71|1.2|||||Hazard ratio is shown as pitavastatin/placebo.|||1.20|0.71|
70953505|NCT02344290|141408776|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.68|1.31|||||Hazard ratio is shown as pitavastatin/placebo.|||1.31|0.68|
70953506|NCT02344290|141408777|SUPERIORITY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.14|2.51|||||Hazard ratio is shown as pitavastatin/placebo.|||2.51|0.14|
70953507|NCT02344290|141408778|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.42|2.02|||||Hazard ratio is shown as pitavastatin/placebo.|||2.02|0.42|
70953508|NCT02344290|141408779|SUPERIORITY||Incidence rate ratio|1.0|||||TWO_SIDED|95.0|0.9|1.1|||||Incidence rate ratio is shown as pitavastatin/placebo.|||1.10|0.90|
70953509|NCT02344290|141408780|SUPERIORITY||Incidence rate ratio|1.29|||||TWO_SIDED|95.0|1.07|1.57|||||Incidence rate ratio is shown as pitavastatin/placebo.|||1.57|1.07|
70953510|NCT02344290|141408781|SUPERIORITY||Incidence rate ratio|1.58|||||TWO_SIDED|95.0|1.14|2.19|||||Incidence rate ratio is shown as pitavastatin/placebo.|||2.19|1.14|
70953511|NCT02344290|141408782|SUPERIORITY||Incidence rate ratio|0.75|||||TWO_SIDED|95.0|0.17|3.37|||||Incidence rate ratio is shown as pitavastatin/placebo.|||3.37|0.17|
70953512|NCT02344290|141408783|SUPERIORITY||Incidence rate ratio|1.34|||||TWO_SIDED|95.0|0.56|3.18|||||Incidence rate ratio is shown as pitavastatin/placebo.|||3.18|0.56|
70953513|NCT02344290|141408784|SUPERIORITY||Incidence rate ratio|1.04|||||TWO_SIDED|95.0|0.97|1.12|||||Incidence rate ratio is shown as pitavastatin/placebo.|||1.12|0.97|
70953514|NCT02344290|141408787|SUPERIORITY||Incidence rate ratio|0.75|||||TWO_SIDED|95.0|0.52|1.08|||||Incidence rate ratio is shown as pitavastatin/placebo.|||1.08|0.52|
70953515|NCT02344290|141408788|SUPERIORITY||Incidence rate ratio|1.05|||||TWO_SIDED|95.0|0.96|1.16|||||Incidence rate ratio is shown as pitavastatin/placebo.|||1.16|0.96|
70953516|NCT02344290|141408789|SUPERIORITY||Mean Difference (Net)|-4.3||||0.04|TWO_SIDED|95.0|-8.6|-0.1|||Regression, Linear||Treatment group difference was estimated as baseline-adjusted mean difference in change at year 2, using linear regression.|||-0.1|-8.6|0.04
70953517|NCT02344290|141408790|SUPERIORITY||Risk Ratio (RR)|0.67||||0.003|TWO_SIDED|95.0|0.52|0.88|||Chi-squared||Treatment effect was estimated as relative risk (pitavastatin/placebo), adjusted for presence of NCP at entry.|||0.88|0.52|0.003
70953518|NCT02344290|141408791|SUPERIORITY||Mean Difference (Net)|-4.3|||||TWO_SIDED|95.0|-9.2|0.62|||||Treatment group difference was estimated as baseline-adjusted difference in mean change at year 2, using linear regression.|||0.62|-9.2|
70953519|NCT02344290|141408792|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of LpPla2 Levels at Month 24||||<0.001
70953520|NCT02344290|141408793|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of Change in LpPla2 from Baseline at Month 24||||<0.001
70953521|NCT02344290|141408794|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Comparison of hsCRP Levels at Month 24||||0.02
70953522|NCT02344290|141408795|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Comparison of Change in hsCRP from Baseline at Month 24||||0.09
70953523|NCT02344290|141408796|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||Comparison of soluble CD163 Levels at Month 24.||||0.65
70953524|NCT02344290|141408797|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Comparison of Change in soluble CD163 from Baseline at Month 24||||0.88
70953525|NCT02344290|141408798|SUPERIORITY|||||||0.98|||||||Regression, Cox|Treatment effect modification by sex was evaluated via interaction of treatment and sex in the Cox proportional hazards regression model.||Evaluation of treatment effect modification by sex (i.e. pitavastatin effect differing in females compared to males).||||0.98
70953526|NCT02344290|141408798|SUPERIORITY||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.39|1.04|||||Hazard ratio is shown as pitavastatin/placebo among females.|Evaluation of pitavastatin effect among females.||1.04|0.39|
70953527|NCT02344290|141408798|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.48|0.86|||||Hazard ratio is shown as pitavastatin/placebo among males.|Evaluation of pitavastatin effect among males.||0.86|0.48|
71145260|NCT02443688|141784388|OTHER|95% 2-sided confidence interval for the Hazard Ratio Relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.87|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|0.61|1.25|||Regression, Cox|||||1.25|0.61|
70953528|NCT02344290|141408799|SUPERIORITY|||||||0.14|||||||Regression, Cox|Treatment effect modification by race was evaluated via interaction of treatment and race in the Cox proportional hazards regression model.||Evaluation of treatment effect modification by race (i.e. pitavastatin effect differing between races).||||0.14
70953529|NCT02344290|141408799|SUPERIORITY||Hazard Ratio (HR)|0.22|||||TWO_SIDED|95.0|0.09|0.59||||||Pitavastatin effect among Asians from subgroup analysis by race.|Hazard ratio is shown as pitavastatin/placebo among Asians.|0.59|0.09|
70953530|NCT02344290|141408799|SUPERIORITY||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.46|0.96|||||Hazard ratio is shown as pitavastatin/placebo among Blacks.|Pitavastatin effect among Blacks from subgroup analysis by race.||0.96|0.46|
70953531|NCT02344290|141408799|SUPERIORITY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.49|1.13|||||Hazard ratio is shown as pitavastatin/placebo among Whites.|Pitavastatin effect among Whites from subgroup analysis by race.||1.13|0.49|
70953532|NCT02344290|141408799|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.36|2.1||||||Pitavastatin effect among Other race from subgroup analysis by race.|Hazard ratio is shown as pitavastatin/placebo among Other race.|2.10|0.36|
70953533|NCT03826030|141408822|SUPERIORITY|||||||0.39|||||||Mixed Models Analysis|||The null hypothesis was no overall difference in FM-UE scale change between the three groups on day 15. The change in FM-UE was modelled using a linear mixed-effects repeated measures model adjusted for visit (ie, day 15, day 45, and day 105), treatment group, treatment group by visit interaction, baseline FM-UE, time from stroke (30-90 vs. 91-180 days), and enrolment site. An AR(1) autocorrelation structure was used for visit, and variance components structure for sites.||||0.39
70953534|NCT05014568|141408826|SUPERIORITY||Risk Ratio, log|2.6|||<|0.0001|TWO_SIDED|95.0|1.66|4.09|||Cochran-Mantel-Haenszel|Stratified by Baseline vIGA-AD Score and Age Group|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|H0: The proportion of subjects who achieve a vIGA-AD score of clear (0) or almost clear (1) and at least a 2-grade reduction from Baseline at Week 8 is equal between tapinarof cream, 1% and vehicle cream; H1: The proportion of subjects who achieve a vIGA-AD score of clear (0) or almost clear (1) and at least a 2-grade reduction from Baseline at Week 8 is different between the tapinarof cream, 1% and vehicle cream.||4.09|1.66|<0.0001
70953535|NCT05014568|141408827|SUPERIORITY||Risk Ratio, log|2.17|||<|0.0001|TWO_SIDED|95.0|1.57|3.0|||Cochran-Mantel-Haenszel|Stratified by vIGA-AD score at Baseline (vIGA-AD scores of 3 or 4) and age group (2-6 yrs, 7-11 yrs, 12-17 yrs, 18+ yrs)|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|||3.00|1.57|<0.0001
70953536|NCT05014568|141408828|SUPERIORITY||Least squares mean difference|-6.17|STANDARD_ERROR_OF_MEAN|0.657|<|0.0001|TWO_SIDED|95.0|-7.69|-4.66|||ANCOVA|age\*vIGA cohort and treatment as categorical covariates, and baseline %BSA as a continuous covariate||||-4.66|-7.69|<0.0001
71145261|NCT02443688|141784394|OTHER|Single Group Rate with 95% CI|see Estimation Comment below|0.84|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|0.49|1.44|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||1.44|0.49|
71145262|NCT02443688|141784394|OTHER|Single Group Rate with 95% CI|see Estimation Comment below|1.28|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|95.0|0.84|1.96|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||1.96|0.84|
71145263|NCT02443688|141784394|OTHER|Single Group Rate with 95% CI|see Estimation Comment below|1.61|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|1.07|2.42|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||2.42|1.07|
71145264|NCT02443688|141784394|OTHER|Group Rate with 95% CI|see Estimation Comment below|1.04|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|0.74|1.46|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||1.46|0.74|
71145265|NCT02443688|141784395|OTHER|95% 2-sided confidence interval for the Hazard Ratio Relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.52|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|0.25|1.1|||Regression, Cox|||||1.10|0.25|
71145266|NCT02443688|141784395|OTHER|95% 2-sided confidence interval for the Hazard Ratio Relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.62|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|0.3|1.27|||Regression, Cox|||||1.27|0.30|
71145267|NCT02443688|141784395|OTHER|95% 2-sided confidence interval for the Hazard Ratio Relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.57|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|0.31|1.05|||Regression, Cox|||||1.05|0.31|
70871217|NCT00618072|141227568|SUPERIORITY_OR_OTHER|||||||0.03|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.03
70871218|NCT00618072|141227568|SUPERIORITY_OR_OTHER|||||||0.15|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.150
70871219|NCT00618072|141227569|SUPERIORITY_OR_OTHER|||||||0.648|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.648
70871220|NCT00618072|141227569|SUPERIORITY_OR_OTHER|||||||0.094|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.094
70871221|NCT00618072|141227569|SUPERIORITY_OR_OTHER|||||||0.054|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.054
71145268|NCT03182374|141784401|SUPERIORITY||||||<|0.0001||||||ITT Population|t-test, 2 sided|||||||<0.0001
71145269|NCT03182374|141784402|SUPERIORITY||||||<|0.0001||||||PP Population|t-test, 2 sided|||||||<0.0001
71145270|NCT03182374|141784403|SUPERIORITY|||||||0.6655||||||PP Population|t-test, 2 sided|||||||0.6655
71145271|NCT03182374|141784404|SUPERIORITY||||||<|0.0001||||||PP Population|t-test, 2 sided|||||||<0.0001
71145272|NCT03182374|141784405|SUPERIORITY||||||<|0.05||||||PP population|t-test, 2 sided|||||||<0.05
71145273|NCT03182374|141784406|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71145274|NCT03402217|141784434|SUPERIORITY|||||||0.383|||||||Wilcoxon (Mann-Whitney)|||Pre and post-score paired comparison.||||.383
71145275|NCT03402217|141784435|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Information pre-post paired comparison||||.001
71145276|NCT03402217|141784435|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Motivation pre- and post-paired comparison.||||.07
71145277|NCT03402217|141784435|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Behavior pre and post paired comparison||||.230
71145278|NCT03486912|141784471|SUPERIORITY||Odds Ratio (OR)|0.88||||0.773|TWO_SIDED|95.0|0.3|2.62|||Cochran-Mantel-Haenszel|||||2.62|0.30|0.773
71145279|NCT03486912|141784471|SUPERIORITY||Odds Ratio (OR)|0.72||||0.544|TWO_SIDED|95.0|0.23|2.23|||Cochran-Mantel-Haenszel|||||2.23|0.23|0.544
71145280|NCT03486912|141784471|SUPERIORITY||Odds Ratio (OR)|0.88||||0.811|TWO_SIDED|95.0|0.3|2.62|||Cochran-Mantel-Haenszel|||||2.62|0.30|0.811
71145281|NCT03486912|141784472|SUPERIORITY||Odds Ratio (OR)|1.12||||0.836|TWO_SIDED|95.0|0.4|3.09|||Cochran-Mantel-Haenszel|||||3.09|0.40|0.836
71145282|NCT03486912|141784472|SUPERIORITY||Odds Ratio (OR)|0.86||||0.763|TWO_SIDED|95.0|0.3|2.46|||Cochran-Mantel-Haenszel|||||2.46|0.30|0.763
71145283|NCT03486912|141784472|SUPERIORITY||Odds Ratio (OR)|0.89||||0.821|TWO_SIDED|95.0|0.32|2.51|||Cochran-Mantel-Haenszel|||||2.51|0.32|0.821
71145284|NCT03486912|141784473|SUPERIORITY||Odds Ratio (OR)|1.13||||0.837|TWO_SIDED|95.0|0.39|3.25|||Cochran-Mantel-Haenszel|||||3.25|0.39|0.837
71145285|NCT03486912|141784473|SUPERIORITY||Odds Ratio (OR)|1.53||||0.359|TWO_SIDED|95.0|0.54|4.4|||Cochran-Mantel-Haenszel|||||4.40|0.54|0.359
71145286|NCT03486912|141784473|SUPERIORITY||Odds Ratio (OR)|1.26||||0.627|TWO_SIDED|95.0|0.44|3.61|||Cochran-Mantel-Haenszel|||||3.61|0.44|0.627
71145287|NCT03486912|141784474|SUPERIORITY||Odds Ratio (OR)|1.12||||0.864|TWO_SIDED|95.0|0.4|3.16|||Cochran-Mantel-Haenszel|||||3.16|0.40|0.864
71145288|NCT03486912|141784474|SUPERIORITY||Odds Ratio (OR)|0.85||||0.743|TWO_SIDED|95.0|0.29|2.49|||Cochran-Mantel-Haenszel|||||2.49|0.29|0.743
71145289|NCT03486912|141784474|SUPERIORITY||Odds Ratio (OR)|0.79||||0.63|TWO_SIDED|95.0|0.27|2.29|||Cochran-Mantel-Haenszel|||||2.29|0.27|0.630
71145290|NCT03486912|141784475|SUPERIORITY||Odds Ratio (OR)|1.43||||0.477|TWO_SIDED|95.0|0.48|4.25|||Cochran-Mantel-Haenszel|||||4.25|0.48|0.477
71145291|NCT03486912|141784475|SUPERIORITY||Odds Ratio (OR)|1.04||||0.814|TWO_SIDED|95.0|0.32|3.44|||Cochran-Mantel-Haenszel|||||3.44|0.32|0.814
71145292|NCT03486912|141784475|SUPERIORITY||Odds Ratio (OR)|0.64||||0.367|TWO_SIDED|95.0|0.21|1.93|||Cochran-Mantel-Haenszel|||||1.93|0.21|0.367
71145293|NCT03486912|141784476|SUPERIORITY|||||||0.309|||||||Cochran-Mantel-Haenszel|||||||0.309
71145294|NCT03486912|141784476|SUPERIORITY|||||||0.146|||||||Cochran-Mantel-Haenszel|||||||0.146
71145295|NCT03486912|141784476|SUPERIORITY|||||||0.317|||||||Cochran-Mantel-Haenszel|||||||0.317
71145296|NCT03486912|141784477|SUPERIORITY||Odds Ratio (OR)|6.91||||0.054|TWO_SIDED|95.0|0.76|325.97|||Cochran-Mantel-Haenszel|||||325.97|0.76|0.054
71145297|NCT03486912|141784477|SUPERIORITY||Odds Ratio (OR)|12.21||||0.004|TWO_SIDED|95.0|1.5|549.08|||Cochran-Mantel-Haenszel|||||549.08|1.50|0.004
71145298|NCT03486912|141784477|SUPERIORITY||Odds Ratio (OR)|5.59||||0.087|TWO_SIDED|95.0|0.57|271.11|||Cochran-Mantel-Haenszel|||||271.11|0.57|0.087
70871222|NCT00618072|141227570|SUPERIORITY_OR_OTHER|||||||0.092|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.092
70871223|NCT00618072|141227570|SUPERIORITY_OR_OTHER|||||||0.73|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.730
70953537|NCT05014568|141408829|SUPERIORITY||Risk Ratio, log|3.74|||<|0.0001|TWO_SIDED|95.0|1.98|7.09|||Cochran-Mantel-Haenszel|Stratified by Baseline vIGA-AD Score and Age Group|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|||7.09|1.98|<0.0001
70953538|NCT05014568|141408830|SUPERIORITY||Risk Ratio, log|1.54||||0.0366|TWO_SIDED|95.0|1.03|2.31|||Cochran-Mantel-Haenszel|Stratified by Baseline vIGA-AD Score and Age Group|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|||2.31|1.03|0.0366
70953539|NCT04893460|141408831|SUPERIORITY|This model is a paired t-test that tests for change in cognitive dissonance from baseline to after the Cost activity|Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|0.33||0.003|TWO_SIDED||||||t-test, 2 sided|||||||.003
70953540|NCT04893460|141408831|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED||||||t-test, 2 sided|||This model is a paired t-test that tests for change in cognitive dissonance from baseline to after the Quit Letter activity||||<.001
70953541|NCT04893460|141408831|SUPERIORITY||Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|0.41||0.004|TWO_SIDED||||||t-test, 2 sided|||This model is a paired t-test that tests for change in cognitive dissonance from baseline to after the Pitfalls activity||||.004
70953542|NCT04893460|141408831|SUPERIORITY||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.48||0.098|TWO_SIDED||||||t-test, 2 sided|||This model is a paired t-test that tests for change in cognitive dissonance from baseline to after the Smoke Free activity||||.098
71145299|NCT02491684|141784478|SUPERIORITY_OR_OTHER||Ratio of proportions|1.29||||0.645|TWO_SIDED|95.0|0.43|3.85|||log-binomial regression model|The ratio of proportions was calculated by back-transforming the estimated treatment effect.|AZD9412 versus Placebo|Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.||3.85|0.43|0.645
70953543|NCT04893460|141408831|SUPERIORITY||Mean Difference (Final Values)|-1.46|STANDARD_ERROR_OF_MEAN|0.68||0.042|TWO_SIDED||||||t-test, 2 sided|||This model is a paired t-test that tests for change in cognitive dissonance from baseline to after the Letter to Youth activity||||.042
70953544|NCT04893460|141408831|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.22||0.364|TWO_SIDED||||||t-test, 2 sided|||This model is a paired t-test that tests for change in cognitive dissonance from baseline to 6 weeks post baseline.||||.364
70953545|NCT04893460|141408832|SUPERIORITY||median pairwise average|17.67|||<|0.001|TWO_SIDED||||||Wilcoxson Signed Rank Test|||The non-parametric Wilcoxon signed-rank test was used to evaluate whether participants were smoking fewer cigarettes per day.||||<.001
70953546|NCT04893460|141408833|SUPERIORITY|This model is a paired t-test that tests for change in readiness to quit smoking from baseline to after the Cost activity|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.42||0.776|TWO_SIDED||||||t-test, 2 sided|||||||.776
71145300|NCT02491684|141784479|SUPERIORITY_OR_OTHER||Ratio of proportions|1.97||||0.411|TWO_SIDED|95.0|0.39|9.89|||log-binomial regression model|The ratio of proportions was calculated by back-transforming the estimated treatment effect.|AZD9412 versus Placebo for Days 1 - 7|Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.||9.89|0.39|0.411
70871224|NCT00618072|141227570|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||<0.001
70953547|NCT04893460|141408833|SUPERIORITY|This model is a paired t-test that tests for change in readiness to quit smoking from baseline to after the Quit Latter activity|Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.45||0.219|TWO_SIDED||||||t-test, 2 sided|||||||.219
70953548|NCT04893460|141408833|SUPERIORITY|This model is a paired t-test that tests for change in readiness to quit smoking from baseline to after the Pitfalls activity|Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|0.55||0.043|TWO_SIDED||||||t-test, 2 sided|||||||.043
70953549|NCT04893460|141408833|SUPERIORITY|This model is a paired t-test that tests for change in readiness to quit smoking from baseline to after the Smoke Free activity|Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.67||0.219|TWO_SIDED||||||t-test, 2 sided|||||||.219
70953550|NCT04893460|141408833|SUPERIORITY|This model is a paired t-test that tests for change in readiness to quit smoking from baseline to after the Letter to Youth activity|Mean Difference (Final Values)|-1.41|STANDARD_ERROR_OF_MEAN|0.54||0.11|TWO_SIDED||||||t-test, 2 sided|||||||.110
70953551|NCT04893460|141408833|SUPERIORITY|This model is a paired t-test that tests for change in readiness to quit smoking from baseline to 6 week post baseline assessment|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.26||0.868|TWO_SIDED||||||t-test, 2 sided|||||||.868
70953552|NCT05718466|141408857|SUPERIORITY|||||||0.11|||||||Log Rank|||||||0.11
70953553|NCT05718466|141408858|SUPERIORITY|||||||0.001|||||||Log Rank|||||||0.001
70953554|NCT01325311|141408881|SUPERIORITY_OR_OTHER|||||||0.922|TWO_SIDED||||||t-test, 2 sided|||Using the Student t-test. If the normality assumption is tenuous, an appropriate transformation of the data such as logarithm will be considered for Student t-test or a nonparametric test such as Wilcoxon rank-sum test will be used for comparison.||||0.922
70953555|NCT00568178|141408896|SUPERIORITY_OR_OTHER_LEGACY||Ratio in Geometric Mean|0.63||||0.001|TWO_SIDED|95.0|0.54|0.74|||Mixed Models Analysis|||||0.74|0.54|0.001
71145301|NCT02491684|141784479|SUPERIORITY_OR_OTHER||Ratio of proportions|1.25||||0.659|TWO_SIDED|95.0|0.46|3.41|||log-binomial regression model|The ratio of proportions was calculated by back-transforming the estimated treatment effect.|AZD9412 versus Placebo for Days 1 - 30|Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.||3.41|0.46|0.659
70953556|NCT00568178|141408897|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.4||||||95.0|-9.9|-1.0|||Mixed Models Analysis|||||-1.0|-9.9|
70953557|NCT00568178|141408898|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6||||||95.0|-9.2|-0.1|||Mixed Models Analysis|||||-0.1|-9.2|
70953558|NCT00568178|141408899|SUPERIORITY_OR_OTHER_LEGACY||Geometric Mean Ratio|1.18|||||TWO_SIDED|95.0|0.86|1.6||No P Value was calculated for this outcome.|Mixed Models Analysis|An unstructured variance-covariance was used.||||1.60|0.86|
70953559|NCT00568178|141408900|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean|-3.8||||||95.0|-15.2|7.6||A P-Value was not calculated for this outcome.|Mixed Models Analysis|||||7.6|-15.2|
70953560|NCT01008553|141408901|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Log Rank|||||||0.0003
70953561|NCT03268603|141408943|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
70953562|NCT04514510|141408949|SUPERIORITY|||||||0.64|||||||ANCOVA with Multiple Imputation|||||||0.64
70953563|NCT04514510|141408955|SUPERIORITY|||||||0.149|||||||Wilcoxon (Mann-Whitney)|||||||0.149
70953564|NCT00406692|141408959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|1.5|<|0.0003|TWO_SIDED|95.0||||Null Hypothesis: No difference in the mean daily standard drinks consumed for the baseline period and the zonisamide treatment weeks|Mixed Models Analysis|||Null Hypothesis: No difference in the mean daily standard drinks consumed between the baseline period and the zonisamide treatment weeks.||||<0.0003
70953565|NCT00406692|141408960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.7|STANDARD_ERROR_OF_MEAN|3.9|<|0.22|TWO_SIDED|95.0|||||Mixed Models Analysis|||Null Hypothesis: No significant change in the mean number of words produced during phonetic portion of the Controlled Word Association Test between the baseline period and the treatment weeks.||||<0.22
70953566|NCT00406692|141408961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|4.0|<|0.55|TWO_SIDED|95.0|||||Mixed Models Analysis|||Null Hypothesis: No significant difference for mean scores obtained for baseline, week 4 and week 12.||||< 0.55
70953567|NCT01145898|141408971|SUPERIORITY_OR_OTHER|||||||0.6261||95.0|||||ANCOVA|||There will be (as shown) differences in the number of subjects based upon the time of analysis due to patient loss, data of insufficient quality at visit, or change in the drug use during period of study (patient switched off treatment by their doctor) so the number of data points varies throughout the analysis by availability.||||.6261
70953568|NCT01145898|141408972|SUPERIORITY_OR_OTHER|||||||0.6081||95.0|||||ANCOVA|||||||.6081
70953569|NCT01145898|141408973|SUPERIORITY_OR_OTHER|||||||0.1822||95.0|||||ANCOVA|||||||.1822
70953570|NCT01145898|141408974|SUPERIORITY_OR_OTHER|||||||0.2383||95.0|||||ANCOVA|||||||.2383
70953571|NCT01145898|141408975|SUPERIORITY_OR_OTHER|||||||0.2383||95.0|||||ANCOVA|||||||.2383
70953572|NCT01145898|141408976|SUPERIORITY_OR_OTHER|||||||0.1564||95.0|||||ANCOVA|||||||.1564
70953573|NCT01145898|141408977|SUPERIORITY_OR_OTHER|||||||0.2265||95.0|||||ANCOVA|||||||.2265
70953574|NCT01145898|141408978|SUPERIORITY_OR_OTHER|||||||0.4645||95.0|||||ANCOVA|||||||.4645
70953575|NCT01145898|141408979|SUPERIORITY_OR_OTHER|||||||0.5998||95.0|||||ANCOVA|||||||.5998
70953576|NCT01145898|141408980|SUPERIORITY_OR_OTHER|||||||0.8119||95.0|||||ANCOVA|||||||.8119
70953577|NCT01145898|141408981|SUPERIORITY_OR_OTHER|||||||0.1319||95.0|||||ANCOVA|||||||.1319
70953578|NCT01145898|141408982|SUPERIORITY_OR_OTHER|||||||0.0199||95.0|||||ANCOVA|||||||.0199
70953579|NCT01145898|141408983|SUPERIORITY_OR_OTHER|||||||0.7597||95.0|||||ANCOVA|||||||.7597
70953580|NCT01145898|141408984|SUPERIORITY_OR_OTHER|||||||0.2528||95.0|||||ANCOVA|||||||.2528
70953581|NCT01167452|141409010|SUPERIORITY_OR_OTHER||Slope|-0.74|STANDARD_DEVIATION|0.19||0.0004|TWO_SIDED||||||Regression, Linear|Multivariate adaptive regression spline (MARS) analysis||We conducted a linear regression analysis of the log transformed elimination rate constant vs. the log transformed weight for each participant.||||0.0004
70953582|NCT01167452|141409010|SUPERIORITY_OR_OTHER||Slope|-0.56|STANDARD_DEVIATION|0.2|<|0.0001|TWO_SIDED||||||Regression, Linear|Multiple Adaptive Regression Spline (MARS)||We conducted a linear regression analysis of the log transformed elimination rate constant vs. the log transformed body mass index for each participant.||||<0.0001
70953583|NCT01417104|141409072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.16|||<|0.031|TWO_SIDED|95.0|0.85|9.47|||t-test, 2 sided|||||9.47|0.85|<0.031
70953584|NCT01417104|141409073|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.4||||0.041|TWO_SIDED|95.0|0.44|4.36|||t-test, 2 sided|||||4.36|0.44|0.041
70953585|NCT03101462|141409075|OTHER|ANOVA||||||0.89|||||||t-test, 2 sided|||A/H1N1 Day 0||||0.89
70953586|NCT03101462|141409075|OTHER|||||||0.00082||||||This is the calculated p-value.|t-test, 2 sided|||A/H1N1 Day 7||||0.00082
70953587|NCT03101462|141409075|OTHER|||||||7.6e-05||||||This is the calculated p-value|t-test, 2 sided|||A/H1N1 Day 45||||0.000076
70953588|NCT03101462|141409075|OTHER|||||||0.63|||||||t-test, 2 sided|||A/H3N2 Day 0||||0.63
70953589|NCT03101462|141409075|OTHER|||||||0.0186||||||This is the calculated p-value|t-test, 2 sided|||A/H3N2 Day 7||||0.0186
70953590|NCT03101462|141409075|OTHER|||||||0.0052||||||This is the calculated p-value|t-test, 2 sided|||A/H3N2 Day 45||||0.0052
70953591|NCT03101462|141409075|OTHER|||||||0.25|||||||t-test, 2 sided|||Influenza B Day 0||||0.25
70953592|NCT03101462|141409075|OTHER|||||||0.061|||||||t-test, 2 sided|||Influenza B Day 7||||0.061
70953593|NCT03101462|141409075|OTHER|||||||0.0025|||||||t-test, 2 sided|||Influenza B Day 45||||0.0025
70953594|NCT03101462|141409076|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and 2, Day 0 and Day 7||||0.24
70953595|NCT03101462|141409076|OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and 2, Day 0 and Day 45||||0.76
70953596|NCT03101462|141409076|OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Live H3N2, Day 0 and Day 7||||0.06
70953597|NCT03101462|141409076|OTHER|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||Live H3N2, Day 0 and Day 45||||0.56
70953598|NCT03101462|141409076|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Flumist, Day 0 and Day 7||||0.04
70953599|NCT03101462|141409076|OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Flumist, Day 0 and Day 45||||0.16
70953600|NCT03101462|141409076|OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and 2, Day 0 and Day 7||||0.02
70953601|NCT03101462|141409076|OTHER|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and 2, Day 0 and Day 45||||0.94
70953602|NCT03101462|141409076|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Live H3N2, Day 0 and Day 7||||0.002
70953603|NCT03101462|141409076|OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Live H3N2, Day 0 and Day 45||||0.16
70953604|NCT03101462|141409076|OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Flumist, Day 0 and Day 7||||0.02
70953605|NCT03101462|141409076|OTHER|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||Flumist, Day 0 and Day 45||||0.98
70953606|NCT03101462|141409077|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.04
70953607|NCT03101462|141409077|OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.02
70953608|NCT03101462|141409077|OTHER|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.95
71145302|NCT02491684|141784480|SUPERIORITY_OR_OTHER||Ratio of proportions|1.1||||0.944|TWO_SIDED|95.0|0.08|15.79|||log-binomial regression model|The ratio of proportions was calculated by back-transforming the estimated treatment effect.|AZD9412 versus Placebo for Days 1 - 14|Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.||15.79|0.08|0.944
71145303|NCT02491684|141784480|SUPERIORITY_OR_OTHER||Ratio of proportions|1.1||||0.944|TWO_SIDED|95.0|0.08|15.79|||log-binomial regression model|The ratio of proportions was calculated by back-transforming the estimated treatment effect.|AZD9412 versus Placebo for Days 1 - 30|Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.||15.79|0.08|0.944
71145304|NCT02491684|141784481|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.634|TWO_SIDED|95.0|0.45|3.77|||Regression, Cox|Hazard ratio was calculated adjusting for treatment group and region.|AZD9412 versus Placebo|Analysis of time to first severe exacerbation within 30 days of treatment start.||3.77|0.45|0.634
71145305|NCT02491684|141784482|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.973|TWO_SIDED|95.0|0.07|16.78|||Regression, Cox|Hazard ratio was calculated adjusting for treatment group and region.|AZD9412 versus Placebo|Analysis of time to first moderate exacerbation within 30 days of treatment start.||16.78|0.07|0.973
71145306|NCT02491684|141784484|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean difference|0.09||||0.495|TWO_SIDED|95.0|-0.17|0.35|||ANCOVA|Change from baseline is analysed using an Analysis of Covariance (ANCOVA) model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo for change from baseline in total score at Visit 4.|Analysis of change from baseline in total score at Visit 4.||0.35|-0.17|0.495
71145307|NCT02491684|141784484|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.715|TWO_SIDED|95.0|-0.26|0.38|||ANCOVA|Change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of change from baseline in total score at Visit 6.||0.38|-0.26|0.715
71145308|NCT02491684|141784484|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.687|TWO_SIDED|95.0|-0.42|0.28|||ANCOVA|Change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of change from baseline in total score at Visit 8.||0.28|-0.42|0.687
71145309|NCT02491684|141784485|SUPERIORITY_OR_OTHER||LS Mean difference|0.11||||0.516|TWO_SIDED|95.0|-0.23|0.45|||ANCOVA|AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of AUC for change from baseline in total score over Days 1-14.||0.45|-0.23|0.516
71145310|NCT02491684|141784485|SUPERIORITY_OR_OTHER||LS mean difference|0.11||||0.417|TWO_SIDED|95.0|-0.16|0.37|||ANCOVA|AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of AUC for change from baseline in total score over Days 1-7.||0.37|-0.16|0.417
70953609|NCT03101462|141409077|OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.17
71145311|NCT02491684|141784485|SUPERIORITY_OR_OTHER||LS mean difference|0.01||||0.954|TWO_SIDED|95.0|-0.34|0.36|||ANCOVA|AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of AUC for change from baseline in total score over Days 8-14.||0.36|-0.34|0.954
71145312|NCT02491684|141784485|SUPERIORITY_OR_OTHER||LS Mean difference|0.0||||0.985|TWO_SIDED|95.0|-0.35|0.35|||ANCOVA|AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of AUC for change from baseline in total score over Days 15-30.||0.35|-0.35|0.985
71145313|NCT02491684|141784487|SUPERIORITY_OR_OTHER||LS Mean difference|-0.07||||0.66|TWO_SIDED|95.0|-0.38|0.24|||ANCOVA|Change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of change from baseline in overall score at Visit 6.||0.24|-0.38|0.660
71145314|NCT02491684|141784487|SUPERIORITY_OR_OTHER||LS Mean difference|-0.09||||0.624|TWO_SIDED|95.0|-0.48|0.29|||ANCOVA|Change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of change from baseline in overall score at Visit 8.||0.29|-0.48|0.624
71145315|NCT02491684|141784488|SUPERIORITY_OR_OTHER||LS Mean difference|0.54||||0.309|TWO_SIDED|95.0|-0.51|1.59|||ANCOVA|AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-14.||1.59|-0.51|0.309
71145316|NCT02491684|141784489|SUPERIORITY_OR_OTHER||LS Mean difference|16.98||||0.059|TWO_SIDED|95.0|-0.63|34.6|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-14.||34.60|-0.63|0.059
71145317|NCT02491684|141784489|SUPERIORITY_OR_OTHER||LS Mean difference|19.35||||0.01|TWO_SIDED|95.0|4.66|34.05|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-7.||34.05|4.66|0.010
71145318|NCT02491684|141784489|SUPERIORITY_OR_OTHER||LS Mean difference|14.38||||0.153|TWO_SIDED|95.0|-5.44|34.2|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 8-14.||34.20|-5.44|0.153
71145319|NCT02491684|141784489|SUPERIORITY_OR_OTHER||LS Mean difference|19.26||||0.096|TWO_SIDED|95.0|-3.44|41.97|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 15-30.||41.97|-3.44|0.096
70953610|NCT03101462|141409077|OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.06
70953611|NCT03101462|141409077|OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.14
70953612|NCT03101462|141409077|OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Live H3N2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.02
70953613|NCT03101462|141409077|OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Live H3N2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.09
70871225|NCT00592384|141227571|SUPERIORITY_OR_OTHER||||||<|0.025||||||Bonferroni corrected for two primary comparisons|Mixed Models Analysis|see above||Primary analyses included observations at baseline, 1, 3, 6, 8, 10, and 12 weeks. Random effects were included for participants' intercepts. Fixed effects were time (linear), treatment (VFN vs. PBO), interaction of time with treatment, stratification factors and potential confounders and variables to improve sensitivity. The primary indicator of treatment effect was the interaction of time by treatment.||||<.025
70871226|NCT00592384|141227584|SUPERIORITY_OR_OTHER||||||<|0.025||||||Bonferroni corrected for two primary outcomes|Mixed Models Analysis|||Primary analyses included observations at baseline, 1, 3, 6, 8, 10, and 12 weeks. Random effects were included for participants' intercepts. Fixed effects were time (linear), treatment (VFN vs. PBO), interaction of time with treatment, stratification factors and potential confounders and variables to improve sensitivity. The primary indicator of treatment effect was the interaction of time by treatment.||||<.025
70871227|NCT00133952|141227627|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63||||0.724|TWO_SIDED|95.0|0.15|2.67|||Fisher Exact|||||2.67|0.15|0.724
70871228|NCT00133952|141227628|SUPERIORITY_OR_OTHER||LS Mean difference|-3.3||||0.616|TWO_SIDED|95.0|-16.5|9.8|||Mixed models repeated measures|||||9.8|-16.5|0.616
70871229|NCT00133952|141227629|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.971|TWO_SIDED|95.0|0.68|1.44|||Cochran-Mantel-Haenszel|||||1.44|0.68|0.971
70871230|NCT00133952|141227631|SUPERIORITY_OR_OTHER||LS Mean difference|0.5||||0.344|TWO_SIDED|95.0|-0.6|1.6|||Mixed models repeated measures|||||1.6|-0.6|0.344
70871231|NCT00133952|141227632|SUPERIORITY_OR_OTHER|||||||0.663||95.0|||||ANCOVA|||||||0.663
70871232|NCT00133952|141227633|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||0.203|TWO_SIDED|95.0|0.37|1.23|||Cochran-Mantel-Haenszel|||||1.23|0.37|0.203
70953614|NCT03101462|141409077|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Flumist CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.01
70871233|NCT00133952|141227635|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.749|TWO_SIDED|95.0|0.46|2.92|||Cochran-Mantel-Haenszel|||||2.92|0.46|0.749
70871234|NCT01976338|141227639|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70871235|NCT00777608|141227649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.231|TWO_SIDED|90.0|-0.2|0.08|||ANOVA|||||0.08|-0.2|0.231
70871236|NCT00777608|141227650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09||0.041|TWO_SIDED|90.0|-0.3|-0.008|||ANOVA||Statistical analysis for Week 2|||-0.008|-0.3|0.041
70871237|NCT00777608|141227650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.143|TWO_SIDED|90.0|-0.3|0.06|||ANOVA||Statistical analysis for Week 8|||0.06|-0.3|0.143
70871238|NCT00777608|141227650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.1||0.226|TWO_SIDED|90.0|-0.2|0.09|||ANOVA||Statistical analysis for Week 12|||0.09|-0.2|0.226
70871239|NCT00777608|141227651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|1.0||0.324|TWO_SIDED|90.0|-1.2|2.2|||ANOVA||Statistical analysis for Week 4|||2.2|-1.2|0.324
70871240|NCT00777608|141227651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|1.4||0.285|TWO_SIDED|90.0|-1.5|3.1|||ANOVA|||||3.1|-1.5|0.285
70871241|NCT00777608|141227651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|1.3||0.401|TWO_SIDED|90.0|-2.6|1.9|||ANOVA||Statistical analysis for Week 12|||1.9|-2.6|0.401
70871242|NCT03766581|141227660|SUPERIORITY||Relative Risk (RR)|0.99|||||TWO_SIDED|95.0|0.87|1.1|||MCP-MOD|Multiple Comparison Procedures, MODel|95% confidence interval (CI) for composite event based on bootstrap (10000 samples)|Milvexian 25 mg QD over Placebo||1.10|0.87|
70871243|NCT03766581|141227660|SUPERIORITY||Relative Risk (RR)|0.99|||||TWO_SIDED|95.0|0.83|1.15|||MCP-MOD|Multiple Comparison Procedures, MODel|95% confidence interval (CI) for composite event based on bootstrap (10000 samples)|Milvexian 25 mg BID over Placebo||1.15|0.83|
70871244|NCT03766581|141227660|SUPERIORITY||Relative Risk (RR)|0.93|||||TWO_SIDED|95.0|0.76|1.16|||MCP-MOD|Multiple Comparison Procedures, MODel|95% confidence interval (CI) for composite event based on bootstrap (10000 samples)|Milvexian 50 mg BID over Placebo||1.16|0.76|
70871245|NCT03766581|141227660|SUPERIORITY||Relative Risk (RR)|0.92|||||TWO_SIDED|95.0|0.73|1.18|||MCP-MOD|Multiple Comparison Procedures, MODel|95% confidence interval (CI) for composite event based on bootstrap (10000 samples)|Milvexian 100 mg BID over Placebo||1.18|0.73|
70871246|NCT03766581|141227660|SUPERIORITY||Relative Risk (RR)|0.91|||||TWO_SIDED|95.0|0.69|1.31|||MCP-MOD|Multiple Comparison Procedures, MODel|95% confidence interval (CI) for composite event based on bootstrap (10000 samples)|Milvexian 200 mg BID over Placebo||1.31|0.69|
70871247|NCT03766581|141227682|SUPERIORITY||Relative Risk (RR)|0.83|||||TWO_SIDED|95.0|0.46|1.49|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 25 mg QD over Placebo||1.49|0.46|
70871248|NCT03766581|141227682|SUPERIORITY||Relative Risk (RR)|0.69|||||TWO_SIDED|95.0|0.36|1.3|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 25 mg BID over Placebo||1.30|0.36|
70871249|NCT03766581|141227682|SUPERIORITY||Relative Risk (RR)|0.72|||||TWO_SIDED|95.0|0.39|1.33|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 50 mg BID over Placebo||1.33|0.39|
70871250|NCT03766581|141227682|SUPERIORITY||Relative Risk (RR)|0.65|||||TWO_SIDED|95.0|0.33|1.25|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 100 mg BID over Placebo||1.25|0.33|
70871251|NCT03766581|141227682|SUPERIORITY||Relative Risk (RR)|1.4|||||TWO_SIDED|95.0|0.87|2.25|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 200 mg BID||2.25|0.87|
70953615|NCT03101462|141409077|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Flumist CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.08
70953616|NCT03101462|141409077|OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.16
70953617|NCT03101462|141409077|OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.76
70953618|NCT03101462|141409077|OTHER|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.84
70953619|NCT03101462|141409077|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.04
70953620|NCT03101462|141409077|OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.07
70953621|NCT03101462|141409077|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.27
70953622|NCT03101462|141409077|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Live H3N2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.11
70953623|NCT03101462|141409077|OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||Live H3N2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.46
70953624|NCT03101462|141409077|OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||Flumist CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.006
70953625|NCT03101462|141409077|OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Flumist CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.41
70953626|NCT03101462|141409078|OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Influenza A/H1N1 HA, Day 0 and Day 45||||0.72
70953627|NCT03101462|141409078|OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Influenza A/H3N2 HA, Day 0 and 45||||0.06
70953628|NCT03101462|141409078|OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Influenza B HA, Day 0 and Day 45||||0.75
70953629|NCT03101462|141409078|OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Influenza A/H1N1 HA, Day 0 and Day 45||||0.05
71145320|NCT02491684|141784490|SUPERIORITY_OR_OTHER||LS Mean difference|0.07||||0.161|TWO_SIDED|95.0|-0.03|0.17|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-14.||0.17|-0.03|0.161
70953630|NCT03101462|141409078|OTHER|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|||Influenza A/H3N2 HA, Day 0 and Day 45||||0.0004
70953631|NCT03101462|141409078|OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Influenza B HA, Day 0 and Day 45||||0.02
70953632|NCT03101462|141409079|OTHER|||||||0.02|||||||Fisher Exact|||Fold increase IgA anti-H1N1 HA, Day 7||||0.02
70953633|NCT03101462|141409079|OTHER|||||||0.67|||||||Fisher Exact|||Fold increase IgA anti-H3N2, Day 7||||0.67
70953634|NCT03101462|141409079|OTHER|||||||0.3|||||||Fisher Exact|||Fold increase IgA anti-influenza B HA, Day 7||||0.30
70953635|NCT01696955|141409116|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
70953636|NCT01696955|141409119|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||||||0.47
70953637|NCT01696955|141409120|SUPERIORITY|||||||0.99|||||||Log Rank|||||||0.99
70953638|NCT01696955|141409121|SUPERIORITY|||||||0.58|||||||Log Rank|||||||0.58
70953639|NCT03192475|141409125|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
70953640|NCT03192475|141409126|SUPERIORITY|||||||0.15|||||||Mixed Models Analysis|||||||0.15
70953641|NCT03192475|141409127|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||0.25
70953642|NCT03192475|141409128|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||||||0.11
70953643|NCT03192475|141409129|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
70953644|NCT03192475|141409130|SUPERIORITY|||||||0.53|||||||Mixed Models Analysis|||||||0.53
70953645|NCT03192475|141409131|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||||||0.21
70953646|NCT03192475|141409132|SUPERIORITY|||||||0.6|||||||Mixed Models Analysis|||||||0.60
70953647|NCT03192475|141409133|SUPERIORITY|||||||0.15|||||||Mixed Models Analysis|||||||0.15
70953648|NCT03192475|141409134|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||||||0.96
70953649|NCT03192475|141409135|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||||||0.96
70953650|NCT03192475|141409136|SUPERIORITY|||||||0.0009|||||||Mantel Haenszel|||||||0.0009
70953651|NCT03192475|141409137|SUPERIORITY|||||||0.18|||||||Mixed Models Analysis|||||||0.18
70953652|NCT03192475|141409138|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|||||||0.34
70953653|NCT03192475|141409139|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||||||0.82
70953654|NCT00573859|141409156|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||A 2 (ADHD medication versus Placebo) repeated measure ANOVA||||<0.05
70953655|NCT00573859|141409157|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||Four-way repeated measure ANOVA||||<0.05
70953656|NCT00573859|141409158|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||Friedman's two analysis of ranks|||Friedman's two-way analysis of variance by ranks.||||<0.05
70953657|NCT05319912|141409159|OTHER||Geometric Mean Ratio (%)|75.81|||||TWO_SIDED|90.0|52.23|110.02||||||Analysis was performed using analysis of variance (ANOVA).||110.02|52.23|
70953658|NCT05319912|141409159|OTHER||Geometric Mean Ratio (%)|25.2|||||TWO_SIDED|90.0|17.21|36.89||||||Analysis was performed using ANOVA.||36.89|17.21|
70953659|NCT05319912|141409160|OTHER||Geometric Mean Ratio (%)|82.65|||||TWO_SIDED|90.0|63.91|106.9||||||Analysis was performed using ANOVA.||106.90|63.91|
70953660|NCT05319912|141409160|OTHER||Geometric Mean Ratio (%)|40.49|||||TWO_SIDED|90.0|31.12|52.68||||||Analysis was performed using ANOVA.||52.68|31.12|
70953661|NCT01276379|141409186|SUPERIORITY||Hazard Ratio (HR)|2.01||||0.004|TWO_SIDED|95.0|1.23|3.29|||Log Rank|||||3.29|1.23|0.004
70953662|NCT01276379|141409187|SUPERIORITY||Hazard Ratio (HR)|2.29|||<|0.0001|TWO_SIDED|95.0|1.33|3.96|||Log Rank|||||3.96|1.33|<0.0001
70953663|NCT00864253|141409192|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.792||||0.044|TWO_SIDED|95.1|0.631|0.992||An interim safety review was performed by DMC. An alpha spending function was utilized to preserve the overall Type 1 error at 0.050. The spending function allocated alpha of 0.001 and 0.049 to the interim and final analyses of PFS, respectively.|Log Rank|The treatment difference was tested using the stratified log-rank test, stratified by metastatic stage, region, and baseline LDH.||Two hundred fifty-seven (257) patients were to be randomized to each treatment group for a total of 514 patients. This sample size was chosen to provide at least 80% power for the final analysis (with a two-sided type I error of 0.049) to reject the null hypothesis that the ABI 007/dacarbazine hazard ratio (HR) for PFS is equal to 1.0. This sample size calculation was based on estimates of HR = 0.750. Proportional hazards were assumed.||0.992|0.631|0.044
71145321|NCT02491684|141784490|SUPERIORITY_OR_OTHER||LS Mean difference|0.08||||0.087|TWO_SIDED|95.0|-0.01|0.17|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-7.||0.17|-0.01|0.087
70953664|NCT00864253|141409193|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.831||||0.094|TWO_SIDED|99.9|0.578|1.196||At the time of the final PFS analysis, an interim analysis of survival was reported. The spending function allocated an alpha of 0.001 and 0.049 for the interim and final analysis, respectively, to preserve the overall Type I error at 0.050.|Log Rank|The treatment difference was tested using the stratified log-rank test, stratified by metastatic stage, region, and baseline LDH.||For the participant survival, at the time at least 417 events are recorded, this sample size provides at least 80% power with a two-sided Type 1 error of 0.049 to reject the null hypothesis that the ABI-007/dacarbazine hazard ratio is equal to 1.0. This was based on a HR = 0.760. Proportional hazards were assumed.||1.196|0.578|0.094
70953665|NCT00864253|141409194|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.845||||0.086|TWO_SIDED|95.0|0.696|1.025|||Log Rank|The treatment difference was tested using the stratified log-rank test, stratified by metastatic stage, region, and baseline LDH.||||1.025|0.696|0.086
71145322|NCT02491684|141784490|SUPERIORITY_OR_OTHER||LS Mean difference|0.06||||0.28|TWO_SIDED|95.0|-0.05|0.16|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 8-14.||0.16|-0.05|0.280
71145323|NCT02491684|141784490|SUPERIORITY_OR_OTHER||LS Mean difference|0.11||||0.086|TWO_SIDED|95.0|-0.02|0.24|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 15-30.||0.24|-0.02|0.086
71145324|NCT02491684|141784491|SUPERIORITY_OR_OTHER||LS Mean difference|11.69||||0.211|TWO_SIDED|95.0|-6.76|30.14|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-14.||30.14|-6.76|0.211
71145325|NCT02491684|141784491|SUPERIORITY_OR_OTHER||LS Mean difference|11.19||||0.125|TWO_SIDED|95.0|-3.18|25.56|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-7.||25.56|-3.18|0.125
71145326|NCT02491684|141784491|SUPERIORITY_OR_OTHER||LS Mean difference|11.14||||0.277|TWO_SIDED|95.0|-9.08|31.36|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 8-14.||31.36|-9.08|0.277
71145327|NCT02491684|141784491|SUPERIORITY_OR_OTHER||LS Mean difference|17.13||||0.161|TWO_SIDED|95.0|-6.92|41.18|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 15-30.||41.18|-6.92|0.161
71145328|NCT02491684|141784492|SUPERIORITY_OR_OTHER||LS Mean difference|0.06||||0.287|TWO_SIDED|95.0|-0.05|0.16|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-14.||0.16|-0.05|0.287
71145329|NCT02491684|141784492|SUPERIORITY_OR_OTHER||LS Mean difference|0.04||||0.457|TWO_SIDED|95.0|-0.06|0.14|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-7.||0.14|-0.06|0.457
70953666|NCT00864253|141409195|SUPERIORITY_OR_OTHER_LEGACY||Response Rate Ratio|1.305||||0.239|TWO_SIDED|95.0|0.837|2.035|||Chi-squared|||||2.035|0.837|0.239
71145330|NCT02491684|141784492|SUPERIORITY_OR_OTHER||LS Mean difference|0.05||||0.315|TWO_SIDED|95.0|-0.05|0.16|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 8-14.||0.16|-0.05|0.315
71145331|NCT02491684|141784492|SUPERIORITY_OR_OTHER||LS Mean difference|0.09||||0.134|TWO_SIDED|95.0|-0.03|0.22|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 15-30.||0.22|-0.03|0.134
71145332|NCT02242942|141784503|SUPERIORITY||Hazard Ratio (HR)|0.33|||<|0.0001|TWO_SIDED|95.0|0.22|0.51|||Log Rank||Hazard ratios were estimated by Cox regression model. Stratification factors: Binet and Geographic region.|||0.51|0.22|<0.0001
71145333|NCT02242942|141784504|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.0001|TWO_SIDED|95.0|0.23|0.53|||Log Rank||Hazard Ratios were estimated by Cox regression model. Stratification factors: Binet and Geographic region.|||0.53|0.23|<0.0001
71145334|NCT02242942|141784505|SUPERIORITY||Difference in Response Rates|13.43||||0.0007|TWO_SIDED|95.0|5.47|21.38||P-value was assessed using Cochran-Mantel-Haenszel (CMH) test stratified by the IvRS randomization stratification factors.|Cochran-Mantel-Haenszel||95% Confidence Interval (CI) for difference in rates were constructed using Anderson-Hauck method.|||21.38|5.47|0.0007
71145335|NCT02242942|141784506|SUPERIORITY||Difference in Response Rates|26.39|||<|0.0001|TWO_SIDED|95.0|17.41|35.36||P-value was assessed using CMH test stratified by the IvRS randomization stratification factors.|Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|||35.36|17.41|<0.0001
71145336|NCT02242942|141784507|SUPERIORITY||Difference in MRD Negative Rates|40.28|||<|0.0001|TWO_SIDED|95.0|31.45|49.1|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|||49.10|31.45|<0.0001
71145337|NCT02242942|141784508|SUPERIORITY||Difference in MRD Negative Rates|39.81|||<|0.0001|TWO_SIDED|95.0|31.27|48.36|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|||48.36|31.27|<0.0001
71145338|NCT02242942|141784510|SUPERIORITY||Difference in MRD Negative Rates|32.87|||<|0.0001|TWO_SIDED|95.0|23.76|41.98|||Chi-squared||95% CI for difference in rates were constructed using Anderson-Hauck method.|||41.98|23.76|<0.0001
71145339|NCT02242942|141784511|SUPERIORITY||Difference in MRD Negative Rates|38.43|||<|0.0001|TWO_SIDED|95.0|30.15|46.71|||Chi-squared||95% CI for difference in rates were constructed using Anderson-Hauck method.|||46.71|30.15|<0.0001
71145340|NCT02242942|141784512|SUPERIORITY||Difference in Response Rates|1.85||||0.5612|TWO_SIDED|95.0|-4.63|8.33||P-value was assessed using Cochran-Mantel-Haenszel (CMH) test stratified by the IvRS randomization stratification factors.|Cochran-Mantel-Haenszel||95% Confidence Interval (CI) for difference in rates were constructed using Anderson-Hauck method.|||8.33|-4.63|0.5612
70953667|NCT00864253|141409196|SUPERIORITY_OR_OTHER_LEGACY||Response Rate Ratio|1.442||||0.004|TWO_SIDED|95.0|1.123|1.582|||Chi-squared|||||1.582|1.123|0.004
70953668|NCT00864253|141409197|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.201||||0.057|TWO_SIDED|95.0|0.959|5.053|||Log Rank|||||5.053|0.959|0.057
70953669|NCT01743989|141409272|SUPERIORITY|||||||0.383|||||||Chi-squared|||||||0.383
71145341|NCT02242942|141784514|SUPERIORITY||Difference in Response Rates|0.93||||0.7169|TWO_SIDED|95.0|-4.66|6.51|||Cochran-Mantel-Haenszel|P-value was assessed using CMH test stratified by the IvRS randomization stratification factors.|95% CI for difference in rates were constructed using Anderson-Hauck method.|||6.51|-4.66|0.7169
71145342|NCT00468169|141784600|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1225||||||Log-rank test comparing PFS between two treatment arms|Log Rank|||||||0.1225
71145343|NCT01283139|141784610|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.057|TWO_SIDED|90.0|1.03|2.71|||Regression, Logistic|||||2.71|1.03|0.057
71145344|NCT01283139|141784610|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.094|TWO_SIDED|90.0|1.01|2.54|||Regression, Logistic|||||2.54|1.01|0.094
70953670|NCT01732822|141409380|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.65|TWO_SIDED|95.0|0.92|1.13||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.13|0.92|0.650
71145345|NCT01283139|141784610|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.031|TWO_SIDED|90.0|1.16|2.94|||Regression, Logistic|||||2.94|1.16|0.031
71145346|NCT01283139|141784611|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88||||0.042|TWO_SIDED|90.0|1.13|3.14|||Regression, Logistic|||||3.14|1.13|0.042
71145347|NCT01283139|141784611|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.264|TWO_SIDED|90.0|0.85|2.35|||Regression, Logistic|||||2.35|0.85|0.264
71145348|NCT01283139|141784611|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.038|TWO_SIDED|90.0|1.14|3.19|||Regression, Logistic|||||3.19|1.14|0.038
71145349|NCT01283139|141784612|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.808|TWO_SIDED|90.0|0.37|3.81|||Regression, Logistic|||||3.81|0.37|0.808
70871252|NCT03766581|141227682|SUPERIORITY||Relative Risk (RR)|2.48|||||TWO_SIDED|95.0|0.83|7.42|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 50 mg QD over Placebo||7.42|0.83|
70871253|NCT03766581|141227682|SUPERIORITY||Relative Risk (RR)|1.01|||||TWO_SIDED|95.0|0.15|6.96|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 100 mg QD over Placebo||6.96|0.15|
70871254|NCT00964860|141227697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.05||0.001|ONE_SIDED|95.0||||a priori threshold for statistical significance = 0.05|ANCOVA||All treatment comparisons were 1-sided with the significance level set at 5%. Units on the MGI Scale.|||||0.001
70871255|NCT00964860|141227698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.05||0.004|ONE_SIDED|95.0||||a priori threshold for statistical significance = 0.05|ANCOVA||All treatment comparisons were 1-sided with the significance level set at 5%|||||0.004
70871256|NCT03716024|141227699|SUPERIORITY||Mean Difference (Final Values)|13.6|||||TWO_SIDED|95.0|1.3|26.0|||||omadacycline minus linezolid|||26.0|1.3|
70871257|NCT03716024|141227700|SUPERIORITY||Mean Difference (Final Values)|4.8|||||TWO_SIDED|95.0|-1.7|11.4|||||omadacycline minus linezolid|||11.4|-1.7|
70871258|NCT03716024|141227701|SUPERIORITY||Mean Difference (Final Values)|13.8|||||TWO_SIDED|95.0|0.9|26.7|||||omadacycline minus linezolid|||26.7|0.9|
70871259|NCT03716024|141227702|SUPERIORITY||Mean Difference (Final Values)|4.3|||||TWO_SIDED|95.0|-5.3|14.0||||||||14.0|-5.3|
70871260|NCT02585960|141227731|SUPERIORITY||Gaussian Statistic estimate|1.96||||0.0545|TWO_SIDED|95.0|-0.038|3.958|||Chi-squared||Approximately Gaussian Statistic is obtained by taking the square root of the Chi-squared test with continuity adjustment.|The proportion of participants with an ABR of 0 during the second 6-month period on BAX 855 prophylaxis, was compared between the 2 prophylaxis arms using a chi-square test with continuity correction at a 2-sided 5% level of significance.||3.958|-0.038|0.0545
70871261|NCT00299104|141227782|SUPERIORITY_OR_OTHER|||||||0.0016||95.0||||The Closure Principle was used to adjust for multiple comparisons.|Kruskal-Wallis|||Comparing all three treatment groups||||0.0016
70871262|NCT00299104|141227782|SUPERIORITY_OR_OTHER|||||||0.1824||95.0||||The Closure Principle was used to adjust for multiple comparisons.|Van-Elteren|||Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline rheumatoid factor (RF) status||||0.1824
70871263|NCT00299104|141227782|SUPERIORITY_OR_OTHER|||||||0.0004||95.0||||The Closure Principle was used to adjust for multiple comparisons.|Van-Elteren|||Rituximab 2 x 1.0 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||||0.0004
70871264|NCT00299104|141227783|SUPERIORITY_OR_OTHER|||||||0.0004||95.0||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Kruskal-Wallis|||Comparing all three treatment groups||||0.0004
71145350|NCT01283139|141784612|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.598|TWO_SIDED|90.0|0.45|4.66|||Regression, Logistic|||||4.66|0.45|0.598
71145351|NCT01283139|141784612|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.884|TWO_SIDED|90.0|0.27|3.02|||Regression, Logistic|||||3.02|0.27|0.884
71145352|NCT01283139|141784613|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.92||||0.044|TWO_SIDED|90.0|1.22|7.01|||Regression, Logistic|||||7.01|1.22|0.044
71145353|NCT01283139|141784613|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.498|TWO_SIDED|90.0|0.62|3.19|||Regression, Logistic|||||3.19|0.62|0.498
71145354|NCT01283139|141784613|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03||||0.049|TWO_SIDED|90.0|1.2|7.68|||Regression, Logistic|||||7.68|1.20|0.049
71145355|NCT01283139|141784614|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.27|TWO_SIDED|90.0|0.85|2.25|||Regression, Logistic|||||2.25|0.85|0.270
71145356|NCT01283139|141784614|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.69||||0.077|TWO_SIDED|90.0|1.04|2.74|||Regression, Logistic|||||2.74|1.04|0.077
71145357|NCT01283139|141784614|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.453|TWO_SIDED|90.0|0.76|2.05|||Regression, Logistic|||||2.05|0.76|0.453
71145358|NCT01075243|141784621|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.71||||0.0009|TWO_SIDED|95.0|1.53|5.89|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID\^6h between Paracetamol 1000 mg caplet and Paracetamol 650 mg caplet.||5.89|1.53|0.0009
71145359|NCT01075243|141784621|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|11.33|||<|0.0001|TWO_SIDED|95.0|8.66|14.0|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID\^6h between Paracetamol 1000 mg caplet and placebo caplet.||14.00|8.66|<0.0001
71145360|NCT01075243|141784621|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.63|||<|0.0001||95.0|4.94|10.31|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID\^6h between Paracetamol 650 mg caplet and placebo caplet.||10.31|4.94|<0.0001
70953671|NCT01732822|141409381|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.738|TWO_SIDED|95.0|0.92|1.12||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.12|0.92|0.738
70953672|NCT01732822|141409382|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.4|TWO_SIDED|95.0|0.92|1.23||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.23|0.92|0.400
70953673|NCT01732822|141409383|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.482|TWO_SIDED|95.0|0.91|1.23||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.23|0.91|0.482
70953674|NCT01732822|141409384|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.913|TWO_SIDED|95.0|0.89|1.11||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.11|0.89|0.913
70953675|NCT01732822|141409385|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.724|TWO_SIDED|95.0|0.92|1.13||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.13|0.92|0.724
70953676|NCT01732822|141409386|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.846|TWO_SIDED|95.0|0.79|1.33||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.33|0.79|0.846
70953677|NCT01732822|141409387|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.298|TWO_SIDED|95.0|0.87|1.05||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.05|0.87|0.298
70953678|NCT01732822|141409388|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.462|TWO_SIDED|95.0|0.9|1.05||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.05|0.90|0.462
70953679|NCT01732822|141409389|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.793|TWO_SIDED|95.0|0.92|1.12|||Regression, Cox|||||1.12|0.92|0.793
70953680|NCT01732822|141409390|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||1|TWO_SIDED|95.0|0.92|1.09|||Regression, Cox|||||1.09|0.92|1.000
70953681|NCT01732822|141409391|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.829|TWO_SIDED|95.0|0.91|1.08|||Regression, Cox|||||1.08|0.91|0.829
70953682|NCT01732822|141409392|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.949|TWO_SIDED|95.0|0.92|1.08|||Regression, Cox|||||1.08|0.92|0.949
70953683|NCT01732822|141409393|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.377|TWO_SIDED|95.0|0.78|1.1|||Regression, Cox|||||1.10|0.78|0.377
70953684|NCT01732822|141409397|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.164|TWO_SIDED|95.0|0.71|1.06|||Regression, Cox|||||1.06|0.71|0.164
70953685|NCT01732822|141409398|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.306|TWO_SIDED|95.0|0.67|1.14|||Regression, Cox|||||1.14|0.67|0.306
70953686|NCT01732822|141409399|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.887|TWO_SIDED|95.0|0.93|1.09|||Regression, Cox|||||1.09|0.93|0.887
70953687|NCT01732822|141409400|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.489|TWO_SIDED|95.0|0.84|1.43|||Regression, Cox|||||1.43|0.84|0.489
70953688|NCT01732822|141409401|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.138|TWO_SIDED|95.0|0.95|1.43|||Regression, Cox|||||1.43|0.95|0.138
70953689|NCT01732822|141409402|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.139|TWO_SIDED|95.0|0.95|1.41|||Regression, Cox|||||1.41|0.95|0.139
70953690|NCT01732822|141409403|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.58|||<|0.001|TWO_SIDED|95.0|1.24|2.0|||Regression, Cox|||||2.00|1.24|<0.001
70953691|NCT02314780|141409404|OTHER||||||=|0.001|||||||ANOVA|||||||=0.001
70953692|NCT02314780|141409405|OTHER||||||=|0.002|||||||ANOVA|||||||=0.002
70953693|NCT02314780|141409406|OTHER||||||=|0.002|||||||ANOVA|||||||=0.002
70953694|NCT02314780|141409407|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
70953695|NCT02314780|141409408|OTHER||||||=|0.138|||||||ANOVA|||||||=0.138
70953696|NCT02314780|141409409|OTHER||||||=|0.696|||||||ANOVA|||||||=0.696
70953697|NCT00215137|141409420|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||A Wilcoxon Signed Rank test was performed on the difference between the open label endpoint and baseline YBOCS scores.||||0.0002
70953698|NCT00215137|141409420|SUPERIORITY_OR_OTHER|||||||0.0417|TWO_SIDED|95.0|||||Wilcoxon Rank Sum Test|||A Wilcoxon Rank Sum Test was performed on the difference in the pre and post randomization YBOCS scores, using grouping to either escitalopram or placebo as a grouping variable.||||.0417
70953699|NCT00384774|141409435|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Headache Response||||1.0000
70953700|NCT00384774|141409435|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0991|||||||Fisher Exact|||Headache Response||||0.0991
70953701|NCT00384774|141409435|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4851|||||||Chi-squared|||Headache Response||||0.4851
71145361|NCT00784563|141784640|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for analysis.|Regression, Linear|||Sample size was estimated using 80% power to detect an effect size of 0.66 SD in VO2max (estimated improvement=10% /estimated SD of change=15%) within each arm at alpha=0.05 and an attrition rate of 25%.||||<0.001
71145362|NCT00784563|141784641|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Regression, Linear|||||||<0.001
71145363|NCT00784563|141784642|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Regression, Linear|||||||0.029
71145364|NCT00784563|141784643|SUPERIORITY_OR_OTHER|||||||0.271|TWO_SIDED||||||Regression, Linear|||||||0.271
71145365|NCT00784563|141784644|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||unadjusted p-value=0.009|Regression, Linear|||||||0.070
71145366|NCT00784563|141784645|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Regression, Linear|||||||<0.001
71145367|NCT00784563|141784646|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Regression, Linear|||||||0.006
71145368|NCT00784563|141784647|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Regression, Linear|||||||0.002
70953702|NCT00384774|141409435|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1178|||||||Chi-squared|||Headache Response||||0.1178
71145369|NCT00784563|141784648|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Regression, Linear|Adjusted for change in total daily equivalent levodopa dose||||||0.003
71145370|NCT00784563|141784649|SUPERIORITY_OR_OTHER||||||=|0.146|TWO_SIDED||||||t-test, 2 sided|||||||=0.146
71145371|NCT00784563|141784650|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||Regression, Linear|||||||0.037
71145372|NCT00784563|141784651|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.057
71145373|NCT01614249|141784652|SUPERIORITY_OR_OTHER||Slope|1.01|STANDARD_ERROR_OF_MEAN|0.8||0.21|TWO_SIDED|95.0|-0.58|2.6||The p-value was adjusted for baseline variations in the analysis of covariance (ANCOVA) regression model. The significance level was set at p-value less than 0.05.|ANCOVA|In ANCOVA, fish oil group was main effect, participant baseline variables were covariates and presence of interaction between covariates was tested.||Null hypothesis: There is no difference in the magnitude of change in BDI-II scores between HIV-seropositive pregnant women on fish oil omega-3 EPA-rich supplements and the control group on soybean oil soft gels. A sample size of 91 women per arm gave an 85% power to detect as statistically significant at 5% level, a true difference of 4 scores in the mean depressive symptom scores between the two arms assuming a within group standard deviation of nine in depressive symptom scores.||2.60|-0.58|0.21
71145374|NCT02787564|141784780|OTHER||||||<|0.001||||||Comparison of difference of fruit and vegetable variety between intervention group and control group.|Wilcoxon (Mann-Whitney)|||||||<0.001
71145375|NCT02787564|141784781|OTHER|||||||0.038||||||Comparison of difference of fruit and vegetable amount between intervention group and control group.|Wilcoxon (Mann-Whitney)|||||||0.038
71145376|NCT02787564|141784782|OTHER|||||||0.026||||||Comparison of difference of fruit and vegetable variety between intervention group and control group.|Wilcoxon (Mann-Whitney)|||||||0.026
71145377|NCT02787564|141784783|OTHER|||||||0.443||||||Comparison of difference of fruit and vegetable amount between intervention group and control group.|Wilcoxon (Mann-Whitney)|||||||0.443
71145378|NCT02787564|141784784|OTHER|||||||0.006||||||Comparison of difference of fruit and vegetable variety between intervention group and control group.|Wilcoxon (Mann-Whitney)|||||||0.006
71145379|NCT02787564|141784785|OTHER|||||||0.029||||||Comparison of difference of fruit and vegetable amount between intervention group and control group.|Wilcoxon (Mann-Whitney)|||||||0.029
71145380|NCT03474588|141784786|SUPERIORITY|||||||0.3||||||Presented is the p value for the interaction between time and treatment.|Regression, Linear|Random Effects Regression Models (RERM), time was log transformed to account for expectation of greater change closer to baseline||||||0.30
71145381|NCT03474588|141784787|SUPERIORITY||Mean Difference (Net)|1.39|STANDARD_ERROR_OF_MEAN|0.94||0.14|TWO_SIDED|95.0|-0.46|3.24||presented is the p value for the interaction of treatment and time in the model.|Regression, Linear|||Random Effects Regression Model (RERM), included in the model were treatment, time and the interaction of time and treatment.||3.24|-0.46|0.14
71145382|NCT03474588|141784788|SUPERIORITY|||||||0.097|||||||ANOVA|||||||0.097
71145383|NCT03474588|141784789|SUPERIORITY|||||||0.802|||||||Chi-squared|||||||0.802
71145384|NCT01607957|141784804|SUPERIORITY||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|95.0|0.58|0.81|||Stratified log-rank test|||||0.81|0.58|<0.0001
71145385|NCT01607957|141784805|SUPERIORITY||Hazard Ratio (HR)|0.48|||<|0.0001|TWO_SIDED|95.0|0.41|0.57|||Stratified log-rank test|||||0.57|0.41|<0.0001
71145386|NCT00498940|141784812|SUPERIORITY_OR_OTHER|||||||0.14||||||Differences in cardiac index between groups were assessed by an independent 2-sample t test.|t-test, 2 sided|||||||.14
71145387|NCT03589859|141784818|OTHER|This was a physiology study, not a treatment trial. The test was for a change in VOR gain.|||||<|0.001|||||||Mixed Models Analysis|||A linear mixed effects model was used to compare pre- and post-training VOR gains||||<0.001
71145388|NCT04966013|141784821|SUPERIORITY||Hazard Ratio (HR)|1.005||||0.9784|TWO_SIDED|95.0|0.717|1.408|||Regression, Cox|||Log Rank Test and Cox PH Regression analyses were performed unstratified||1.408|0.717|0.9784
71145389|NCT04966013|141784822|SUPERIORITY||Hazard Ratio (HR)|1.388||||0.1512|TWO_SIDED|95.0|0.887|2.172||Log Rank Test and Cox PH Regression analyses were performed unstratified|Regression, Cox|||||2.172|0.887|0.1512
71145390|NCT05010707|141784833|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|||Time x treatment (month 0, and 1 month)||||0.005
70953703|NCT00384774|141409435|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1093|||||||Chi-squared|||Headache Response||||0.1093
71145391|NCT05010707|141784833|SUPERIORITY||Mean Difference (Final Values)|-225.3||||0.02|TWO_SIDED|95.0|-421.71|-28.79|||Mixed Models Analysis|||||-28.79|-421.71|0.02
71145392|NCT05010707|141784833|SUPERIORITY||Mean Difference (Final Values)|-250.6||||0.009|TWO_SIDED|95.0|-447.1|-54.19|||Mixed Models Analysis|||||-54.19|-447.10|0.009
71145393|NCT05010707|141784834|SUPERIORITY|||||||0.951|||||||Mixed Models Analysis|||Time x treatment (month 0 and month 1)||||0.951
71145394|NCT05010707|141784834|SUPERIORITY||Mean Difference (Final Values)|-1.6||||1|TWO_SIDED|95.0|-29.6|26.4|||Mixed Models Analysis||The mean difference is computed using the model based estimates rather than from the raw data.|||26.4|-29.6|1
71145395|NCT05010707|141784834|SUPERIORITY||Mean Difference (Final Values)|-7.1||||1|TWO_SIDED|95.0|-35.1|20.8|||Mixed Models Analysis||The mean difference is computed using the model based estimates rather than from the raw data.|||20.8|-35.1|1
71145396|NCT05010707|141784835|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||Time x treatment (month 0 and month 1)||||0.004
71145397|NCT05010707|141784835|SUPERIORITY||Mean Difference (Final Values)|-280.4||||0.005|TWO_SIDED|95.0|-487.3|-73.5|||Mixed Models Analysis|||||-73.5|-487.3|0.005
71145398|NCT05010707|141784835|SUPERIORITY||Mean Difference (Final Values)|-204.1||||0.054|TWO_SIDED|95.0|-411.1|2.8|||Mixed Models Analysis|||||2.8|-411.1|0.054
71145399|NCT03518086|141784836|SUPERIORITY||Risk Difference (RD)|11.1||||6e-05|TWO_SIDED|99.875|3.2|19.1|||Cochran-Mantel-Haenszel|||||19.1|3.2|0.00006
71145400|NCT03518086|141784837|SUPERIORITY||Risk Difference (RD)|21.4|||<|1e-05|TWO_SIDED|99.875|10.8|32.0|||Cochran-Mantel-Haenszel|||||32.0|10.8|<0.00001
71145401|NCT03518086|141784838|SUPERIORITY||Risk Difference (RD)|15.4|||<|1e-05|TWO_SIDED|99.875|6.3|24.5|||Cochran-Mantel-Haenszel|||||24.5|6.3|<0.00001
71145402|NCT03518086|141784839|SUPERIORITY||Risk Difference (RD)|17.5|||<|0.001|TWO_SIDED|99.875|11.4|23.6|||Cochran-Mantel-Haenszel|||||23.6|11.4|<0.001
71145403|NCT03518086|141784840|SUPERIORITY||Risk Difference (RD)|20.2|||<|0.001|TWO_SIDED|95.0|13.8|26.6|||Cochran-Mantel-Haenszel|||||26.6|13.8|<0.001
71145404|NCT03518086|141784841|SUPERIORITY||Risk Difference (RD)|13.7|||<|0.001|TWO_SIDED|95.0|8.6|18.7|||Cochran-Mantel-Haenszel|||||18.7|8.6|<0.001
71145405|NCT03518086|141784842|SUPERIORITY||Risk Difference (RD)|19.5|||<|1e-05|TWO_SIDED|95.0|13.2|25.8|||Cochran-Mantel-Haenszel|||||25.8|13.2|<0.00001
71145406|NCT03518086|141784843|SUPERIORITY||Mean Difference (Net)|-0.95|STANDARD_ERROR_OF_MEAN|0.159|<|1e-05|TWO_SIDED|99.875|-1.47|-0.44|||Mixed Models Analysis||The confidence interval of 99.875 % was chosen to match the significance level.|||-0.44|-1.47|<0.00001
70953704|NCT00384774|141409435|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3364|||||||Fisher Exact|||Headache Response||||0.3364
70953705|NCT00264303|141409450|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25||||0.005||95.0|0.08|0.43|||ANCOVA|ANCOVA with treatment and pooled center as factors and baseline CIU composite score as covariate.||||0.43|0.08|0.005
71145407|NCT03518086|141784844|SUPERIORITY||Mean Difference (Net)|13.21|STANDARD_ERROR_OF_MEAN|2.005|<|0.001|TWO_SIDED|95.0|9.28|17.15|||ANCOVA|||||17.15|9.28|<0.001
71145408|NCT03518086|141784845|SUPERIORITY||Mean Difference (Net)|-935.6|STANDARD_ERROR_OF_MEAN|218.09|<|0.001|TWO_SIDED|95.0|-1363.64|-507.55|||Mixed Models Analysis|||||-507.55|-1363.64|<0.001
71145409|NCT00626106|141784870|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.542|TWO_SIDED|95.0|-0.11|0.07|||ANCOVA|||||0.07|-0.11|0.542
71145410|NCT01428258|141784893|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-147.0|STANDARD_ERROR_OF_MEAN|39.0||0.0008|TWO_SIDED||||||ANCOVA|||||||0.0008
71145411|NCT01428258|141784893|OTHER|||||||0.136|||||||ANCOVA|||||||0.136
71145412|NCT01428258|141784893|OTHER|||||||0.044|||||||ANCOVA|||||||0.044
71145413|NCT01428258|141784894|OTHER|||||||0.576|||||||ANOVA|||||||0.576
71145414|NCT01428258|141784895|OTHER|||||||0.902|||||||t-test, 2 sided|||||||0.902
71145415|NCT01428258|141784896|OTHER|||||||0.797|||||||t-test, 2 sided|||||||0.797
71145416|NCT01428258|141784897|OTHER|||||||0.0001|||||||ANOVA|||||||0.0001
71145417|NCT00248625|141784901|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Log Rank|||||||0.19
71145418|NCT00248625|141784902|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Log Rank|||||||0.03
71145419|NCT00248625|141784903|SUPERIORITY_OR_OTHER|||||||0.21|||||||Pepe and Mori test of CIF difference|||||||0.21
71145420|NCT00248625|141784904|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED||||||Kruskal-Wallis|||||||0.053
71145421|NCT00248625|141784905|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Cochran-Armitage trend|||||||0.29
71145422|NCT00248625|141784906|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||Cochran-Armitage trend|||||||0.74
71145423|NCT00248625|141784907|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||Cochran-Armitage tren|||||||0.54
71145424|NCT00248625|141784908|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Chi-squared|||||||0.86
71145425|NCT03085095|141784909|NON_INFERIORITY|The lower bound of the 95% CI for the difference in the cumulative probability of sustained profound castration rate between the 2 treatment groups was calculated with a noninferiority margin of -10%.|Treatment difference|7.9|||||TWO_SIDED|95.0|4.1|11.8|||||Treatment difference= Relugolix - Leuprolide acetate|Following statistical analysis of the lower bound of the 95% CI ≥ 90% for the relugolix group, secondary statistical analysis of non-inferiority was conducted.||11.8|4.1|
71145426|NCT03085095|141784909|SUPERIORITY|If non-inferiority was demonstrated, superiority could be claimed if the lower bound of the 95% CI for the difference in the cumulative probability of sustained profound castration rate between the 2 treatment groups also excluded 0%. The p value was calculated post hoc.|||||<|0.0001|||||||t-test, 2 sided|Two-sided type I error of 0.05.||Following statistical analysis of the lower bound of the 95% CI ≥ 90% for the relugolix group, secondary statistical analysis of superiority was conducted.||||< 0.0001
71145427|NCT03085095|141784910|SUPERIORITY||||||<|0.0001||||||Statistically significance was met if p-value \< 0.05.|t-test, 2 sided|Two-sided type I error rate of 0.05.||Alpha-protected statistical analysis.||||< 0.0001
70953706|NCT00264303|141409451|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.041||95.0|0.01|0.34|||ANCOVA|ANCOVA with treatment and pooled center as factors and baseline CIU composite score as covariate||||0.34|0.01|0.041
70871265|NCT00299104|141227783|SUPERIORITY_OR_OTHER|||||||0.1194||95.0||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Van-Elteren|||Rituximab 2 x 0.5 g + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status||||0.1194
70953707|NCT00264303|141409452|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13||||0.004||95.0|0.04|0.22|||ANCOVA|ANCOVA with treatment and pooled center as factors and baseline pruritus severity score as covariate.||||0.22|0.04|0.004
70953708|NCT00264303|141409453|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.002||95.0|0.06|0.26|||ANCOVA|ANCOVA with treatment and pooled center as factors and baseline pruritus duration as covariate.||||0.26|0.06|0.002
70953709|NCT00264303|141409454|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12||||0.009||95.0|0.03|0.22|||ANCOVA|ANCOVA with treatment and pooled centers as factors and baseline pruritus duration score as covariate.||||0.22|0.03|0.009
70953710|NCT00264303|141409455|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|||<|0.001||95.0|0.07|0.26|||ANCOVA|ANCOVA with treatment and pooled center as factors and baseline severity as covariate.||The primary hypothesis to be tested in this study was that the clinical efficacy of Levocetirizine 5 mg is superior to that of Desloratidine 5 mg||0.26|0.07|<0.001
70953711|NCT02815579|141409456|SUPERIORITY||Difference in log odds|-0.08||||0.86|TWO_SIDED|95.0|-1.0|0.84|||Mixed Models Analysis|||The investigators produced a difference-in-difference estimate between baseline and year 2 using multi-level logistic regression. Units are in log odds.||0.84|-1.0|0.86
70953712|NCT02815579|141409457|SUPERIORITY||Difference in log odds|0.32||||0.23|TWO_SIDED|95.0|-0.28|0.92|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2 using multi-level logistic regression. Units are in log odds.||0.92|-0.28|0.23
70953713|NCT02815579|141409458|SUPERIORITY||Mean Difference (Net)|1.39||||0.26|TWO_SIDED|95.0|-1.01|3.78|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2.||3.78|-1.01|0.26
70953714|NCT02815579|141409459|SUPERIORITY||Difference in log odds|0.84||||0.31|TWO_SIDED|95.0|-0.79|2.47|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2 using multi-level logistic regression. Units are in log odds.||2.47|-0.79|0.31
70953715|NCT02815579|141409460|SUPERIORITY||Difference in log odds|-0.34||||0.44|TWO_SIDED|95.0|-1.22|0.53|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2 using multi-level logistic regression. Units are in log odds.||0.53|-1.22|0.44
70953716|NCT02815579|141409461|SUPERIORITY||Mean Difference (Net)|-3.54|||<|0.001|TWO_SIDED|95.0|-4.16|-2.92|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2.||-2.92|-4.16|<0.001
70871266|NCT00299104|141227783|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Van-Elteren|||Rituximab 2 x 1.0 g + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status||||0.0001
70953717|NCT02815579|141409462|SUPERIORITY||Mean Difference (Net)|-0.21||||0.02|TWO_SIDED|95.0|-0.39|-0.04|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2.||-0.04|-0.39|0.02
70953718|NCT02815579|141409463|SUPERIORITY||Mean Difference (Net)|0.01||||0.98|TWO_SIDED|95.0|-0.82|0.84|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2.||0.84|-0.82|0.98
70953719|NCT02815579|141409464|SUPERIORITY||Mean Difference (Net)|-0.37||||0.001|TWO_SIDED|95.0|-0.59|-0.15|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2.||-0.15|-0.59|0.001
70953720|NCT02815579|141409465|SUPERIORITY||Difference in log odds|-0.83||||0.001|TWO_SIDED|95.0|-1.45|-0.2|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2 using multi-level logistic regression. Units are in log odds.||-0.20|-1.45|0.001
70953721|NCT02815579|141409466|SUPERIORITY||Mean Difference (Net)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.52|-0.31|||Mixed Models Analysis|||||-0.31|-0.52|<0.001
70953722|NCT02389452|141409467|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||||||<0.0001
70953723|NCT02311673|141409485|OTHER||Least Squares (LS) Mean Difference|-0.3||||0.42|TWO_SIDED|95.0|-3.1|2.5||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.5|-3.1|0.420
70953724|NCT02311673|141409485|OTHER||LS Mean Difference|-0.4||||0.348|TWO_SIDED|95.0|-2.3|1.6|||Longitudinal mixed analysis of variance|One sided p-value.|A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||1.6|-2.3|0.348
70953725|NCT02311673|141409485|OTHER||LS Mean Difference|0.8||||0.779|TWO_SIDED|95.0|-1.3|2.9||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.9|-1.3|0.779
70953726|NCT02311673|141409487|OTHER||LS Mean Difference|21.5||||0.901|TWO_SIDED|95.0|-11.8|54.8||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||54.8|-11.8|0.901
70953727|NCT02311673|141409487|OTHER||LS Mean Difference|-3.9||||0.362|TWO_SIDED|95.0|-26.3|18.5||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||18.5|-26.3|0.362
70953728|NCT02311673|141409487|OTHER||LS Mean Difference|-3.7||||0.378|TWO_SIDED|95.0|-28.0|20.5||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||20.5|-28.0|0.378
71145428|NCT03085095|141784911|SUPERIORITY||||||<|0.0001||||||Statistically significance was met if p-value \< 0.05.|t-test, 2 sided|Two-sided type I error rate of 0.05.||Alpha-protected statistical analysis.||||< 0.0001
70871267|NCT00299104|141227784|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.3803||95.0|-0.05|0.13||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||0.13|-0.05|0.3803
70953729|NCT02311673|141409488|OTHER||LS Mean Difference|20.6||||0.84|TWO_SIDED|95.0|-20.9|62.2||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||62.2|-20.9|0.840
70953730|NCT02311673|141409488|OTHER||LS Mean Difference|-10.2||||0.236|TWO_SIDED|95.0|-38.7|18.4||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||18.4|-38.7|0.236
70953731|NCT02311673|141409488|OTHER||LS Mean Difference|-13.4||||0.191|TWO_SIDED|95.0|-44.2|17.4|||Longitudinal mixed analysis of variance|One sided p-value.||||17.4|-44.2|0.191
70953732|NCT02311673|141409489|OTHER||LS Mean Difference|19.5||||0.812|TWO_SIDED|95.0|-24.8|63.8||One sided p-value.|Longitudinal mixed analysis of variance||||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|63.8|-24.8|0.812
70953733|NCT02311673|141409489|OTHER||LS Mean Difference|-1.3||||0.464|TWO_SIDED|95.0|-29.9|27.4||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||27.4|-29.9|0.464
70953734|NCT02311673|141409489|OTHER||LS Mean Difference|-2.6||||0.432|TWO_SIDED|95.0|-33.6|28.4||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||28.4|-33.6|0.432
70953735|NCT02311673|141409490|OTHER||LS Mean Difference|49.9||||0.988|TWO_SIDED|95.0|6.7|93.2||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||93.2|6.7|0.988
70953736|NCT02311673|141409490|OTHER||LS Mean Difference|16.0||||0.859|TWO_SIDED|95.0|-13.7|45.6||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||45.6|-13.7|0.859
70953737|NCT02311673|141409490|OTHER||LS Mean Difference|22.2||||0.916|TWO_SIDED|95.0|-9.8|54.3||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||54.3|-9.8|0.916
71145429|NCT03085095|141784912|SUPERIORITY||||||<|0.0001||||||Statistically significance was met if p-value \< 0.05.|Cochran-Mantel-Haenszel|||Alpha-protected statistical analysis.||||< 0.0001
70953738|NCT02311673|141409491|OTHER||LS Mean Difference|32.7||||0.943|TWO_SIDED|95.0|-8.4|73.8||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||73.8|-8.4|0.943
70953739|NCT02311673|141409491|OTHER||LS Mean Difference|-4.2||||0.339|TWO_SIDED|95.0|-24.4|16.1||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||16.1|-24.4|0.339
70953740|NCT02311673|141409491|OTHER||LS Mean Difference|1.1||||0.533|TWO_SIDED|95.0|-25.0|27.2||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||27.2|-25.0|0.533
71145430|NCT03085095|141784913|SUPERIORITY||Treatment difference|77.41|||<|0.0001|TWO_SIDED|95.0|73.98|80.83||Statistically significance was met if p-value \< 0.05.|t-test, 2 sided|Two-sided type I error rate of 0.05.|Treatment difference= Relugolix - Leuprolide acetate|Alpha-protected statistical analysis.||80.83|73.98|< 0.0001
71145431|NCT03085095|141784914|SUPERIORITY||||||<|0.0001||||||Statistically significance was met if p-value \< 0.05.|t-test, 2 sided|Two-sided type I error rate of 0.05.||Alpha-protected statistical analysis.||||< 0.0001
71145432|NCT03085095|141784918|OTHER||Treatment difference|13.0|||||TWO_SIDED|95.0|6.9|19.1|||||Treatment difference= Relugolix - Leuprolide acetate|||19.1|6.9|
70953741|NCT02311673|141409499|OTHER||LS Mean Difference|-0.2||||0.439|TWO_SIDED|95.0|-3.0|2.6||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.6|-3.0|0.439
70953742|NCT02311673|141409499|OTHER||LS Mean Difference|-0.3||||0.366|TWO_SIDED|95.0|-2.3|1.6||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||1.6|-2.3|0.366
71145433|NCT03085095|141784920|OTHER||Treatment difference|-2.9|||||TWO_SIDED|95.0|-7.8|2.0|||||Treatment difference= Relugolix - Leuprolide acetate|||2.0|-7.8|
71145434|NCT00408317|141784936|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.74|||<|0.0001|||||||Mixed Models Analysis|||P-values are from a semi-parametric mixed model on ranked CFA% values including sequence, period, and treatment group as fixed effects; participant identification (ID) as random effect.||||<0.0001
71145435|NCT00408317|141784937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.68|||<|0.0001|||||||Mixed Models Analysis|||P-values are from a semi-parametric mixed model on ranked CNA% values including sequence, period, and treatment group as fixed effects, and participant ID as random effect.||||<0.0001
70871268|NCT00299104|141227784|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.0309||95.0|0.01|0.18||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab 2 x 1.0 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||0.18|0.01|0.0309
70871269|NCT00299104|141227785|SUPERIORITY_OR_OTHER|||||||0.3752||95.0||||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab (0.5 g x 2) + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status.||||0.3752
70871270|NCT00299104|141227785|SUPERIORITY_OR_OTHER|||||||0.0081||95.0||||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab (1.0 g x 2) + Methotrexate verus Placebo + Methotrexate, stratified for region and Baseline RF status.||||0.0081
70871271|NCT00299104|141227786|SUPERIORITY_OR_OTHER|||||||0.5939||95.0||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Kruskal-Wallis|||Comparing all three treatment groups.||||0.5939
70953743|NCT02311673|141409499|OTHER||LS Mean Difference|0.7||||0.744|TWO_SIDED|95.0|-1.4|2.8||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.8|-1.4|0.744
70953744|NCT02311673|141409500|OTHER||LS Mean Difference|1.0||||0.883|TWO_SIDED|95.0|-0.7|2.8||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.8|-0.7|0.883
70953745|NCT02311673|141409500|OTHER||LS Mean Difference|-0.2||||0.338|TWO_SIDED|95.0|-1.3|0.9||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||0.9|-1.3|0.338
70953746|NCT02311673|141409500|OTHER||LS Mean Difference|-0.2||||0.381|TWO_SIDED|95.0|-1.6|1.2||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||1.2|-1.6|0.381
70953747|NCT02311673|141409502|OTHER||LS Mean Difference|1.3||||0.679|TWO_SIDED|95.0|-4.5|7.0||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|Statistical analysis is provided for percent change from baseline at Day 56.||7.0|-4.5|0.679
70953748|NCT02311673|141409502|OTHER||LS Mean Difference|0.7||||0.641|TWO_SIDED|95.0|-3.3|4.7||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|Statistical analysis is provided for percent change from baseline at Day 56.||4.7|-3.3|0.641
70953749|NCT02311673|141409502|OTHER||LS Mean Difference|1.9||||0.809|TWO_SIDED|95.0|-2.6|6.4||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|Statistical analysis is provided for percent change from baseline at Day 56.||6.4|-2.6|0.809
70871272|NCT00299104|141227786|SUPERIORITY_OR_OTHER|||||||0.5478||95.0||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Van-Elteren|||Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||||0.5478
70871273|NCT00299104|141227786|SUPERIORITY_OR_OTHER|||||||0.3096||95.0||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Van-Elteren|||Rituximab 2 x 1.0 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||||0.3096
70871274|NCT00299104|141227791|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||||<0.0001
70871275|NCT00299104|141227791|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab 2 x 1.0 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||||<0.0001
70871276|NCT00299104|141227801|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Secondary endpoint in hierarchical testing structure.|ANOVA|||Rituximab (0.5 g x 2) + Methotrexate versus Placebo + Methotrexate stratified for region and RF status.||||<0.0001
70871277|NCT00299104|141227801|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Secondary endpoint in hierarchical testing structure.|ANOVA|||Rituximab (1.0 g x 2) + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status.||||<0.0001
70953750|NCT02311673|141409503|OTHER||LS Mean Difference|0.5||||0.633|TWO_SIDED|95.0|-2.6|3.6||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||3.6|-2.6|0.633
70953751|NCT02311673|141409503|OTHER||LS Mean Difference|0.1||||0.528|TWO_SIDED|95.0|-2.1|2.3||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.3|-2.1|0.528
70953752|NCT02311673|141409503|OTHER||LS Mean Difference|0.5||||0.648|TWO_SIDED|95.0|-2.0|2.9||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.9|-2.0|0.648
70953753|NCT02311673|141409505|OTHER||LS Mean Difference|0.7||||0.712|TWO_SIDED|95.0|-1.8|3.1||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||3.1|-1.8|0.712
70953754|NCT02311673|141409505|OTHER||LS Mean Difference|-0.2||||0.414|TWO_SIDED|95.0|-1.9|1.5||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||1.5|-1.9|0.414
70953755|NCT02311673|141409505|OTHER||LS Mean Difference|0.6||||0.732|TWO_SIDED|95.0|-1.3|2.5||One sided p-value|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.5|-1.3|0.732
70871278|NCT00299104|141227807|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||This was a secondary endpoint in a hierarchical testing structure.|Van-Elteren|||Week 104: Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline rheumatoid factor (RF) status.||||<0.0001
70871279|NCT00299104|141227811|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Secondary endpoint in hierarchical testing structure.|ANOVA|||Rituximab (0.5 g x 2) + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status.||||<0.0001
70871280|NCT00299104|141227811|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Secondary endpoint in hierarchical testing structure.|ANOVA|||Rituximab (1.0 g x 2) + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status.||||<0.0001
70871281|NCT00044083|141227818|OTHER||||||<|0.0001||||||Diagnosis effect on placebo|ANOVA|||||||<0.0001
70871282|NCT00044083|141227818|OTHER|||||||0.0034||||||Drug Effect on Patients|ANOVA|||||||0.0034
70871283|NCT00044083|141227819|OTHER||||||<|0.0001||||||Diagnosis Effect on Placebo in right DLPFC|ANOVA|||||||<0.0001
70871284|NCT00044083|141227819|OTHER|||||||0.014||||||Diagnosis Effect of Placebo in left DLPFC|ANOVA|||||||0.014
70871285|NCT00044083|141227820|OTHER|||||||0.05||||||Drug Effect across both groups in left DLPFC|ANOVA|||||||0.05
70871286|NCT00044083|141227820|OTHER|||||||0.32||||||Drug Effect across both groups in right DLPFC|ANOVA|||||||0.32
70871287|NCT00044083|141227821|OTHER|||||||0.05||||||The Effect of Drug on Patients with Schizophrenia in right DLPFC|t-test, 1 sided|||||||0.05
70871288|NCT00044083|141227821|OTHER|||||||0.078||||||Effect of Drug on Patients with Schizophrenia in left DLPFC|t-test, 1 sided|||||||0.078
70871289|NCT00044083|141227822|OTHER|||||||0.05||||||Drug Effect on Healthy Volunteers in left DLPFC|t-test, 1 sided|||||||0.05
70871290|NCT00044083|141227822|OTHER|||||||0.73||||||Drug Effect on Healthy Volunteers in right DLPFC|t-test, 1 sided|||||||0.73
70871291|NCT00044083|141227823|OTHER||||||<|0.0001|||||||ANOVA|Main Effect of Genotype across both Placebo and Tolcapone in right DLPFC||||||<0.0001
70871292|NCT00044083|141227823|OTHER|||||||0.167|||||||ANOVA|Main Effect of Genotype across both Placebo and Tolcapone in left DLPFC||||||0.167
70871293|NCT00044083|141227824|OTHER|||||||0.189||||||Drug by Genotype Effect in left DLPFC|ANOVA|||||||0.189
70871294|NCT00044083|141227824|OTHER|||||||0.041||||||Drug Effect on Val/Val Genotype in left DLPFC|t-test, 1 sided|||||||0.041
70871295|NCT00044083|141227824|OTHER|||||||0.718||||||Drug Effect on Val/Met Genotype in left DLPFC|t-test, 1 sided|||||||0.718
70871296|NCT00044083|141227824|OTHER|||||||0.469||||||Drug Effect of Met/Met Genotype in left DLPFC|t-test, 1 sided|||||||0.469
70871297|NCT00044083|141227825|OTHER|||||||0.7||||||Drug Effect on Positive Syndrome for Patients|t-test, 1 sided|||||||0.7
70871298|NCT00044083|141227825|OTHER|||||||0.4||||||Drug Effect on Negative Syndrome for Patients|t-test, 1 sided|||||||0.4
70871299|NCT00044083|141227825|OTHER|||||||0.12||||||Drug Effect on General Pathology for Patients|t-test, 1 sided|||||||0.12
70871300|NCT01619423|141227826|SUPERIORITY||Odds Ratio (OR)|0.78||||0.31|ONE_SIDED|10.0||1.5|||Cochran-Mantel-Haenszel|||||1.5||0.31
70871301|NCT01619423|141227826|SUPERIORITY||Odds Ratio (OR)|0.55||||0.15|ONE_SIDED|10.0||1.16|||Cochran-Mantel-Haenszel|||||1.16||0.15
70871302|NCT01619423|141227826|SUPERIORITY||Odds Ratio (OR)|0.62||||0.16|ONE_SIDED|10.0||1.14|||Cochran-Mantel-Haenszel|||||1.14||0.16
70871303|NCT02340975|141227833|OTHER|Comparison|Mean Difference (Net)|11.1||||0.2376|TWO_SIDED|95.0|-0.7|23.0|||Fisher Exact|||||23.0|-0.7|0.2376
70871304|NCT02340975|141227833|OTHER|Comparison|Median Difference (Net)|2.8||||1|TWO_SIDED|95.0|-16.8|22.4|||Fisher Exact|||||22.4|-16.8|1.0000
70871305|NCT00601458|141227866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.7||||0.005||97.8|-73.6|-8.0||1-sided alpha = 0.045 Hochberg closed testing procedure|ANOVA||The natural log scale treatment difference (pregabalin - placebo) and 97.8% CI for the treatment difference were exponentiated and reported as a percentage reduction in 24-h cumulative hydromorphone consumption.|||-8.0|-73.6|0.005
70953756|NCT00414908|141409517|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Non parametric ANCOVA|||The following null hypothesis was tested (μ0 and μ1 denote the treatment group means respectively in the placebo and pancrelipase delayed release capsules group): H0: μ0 = μ1 (i.e., placebo and pancrelipase delayed release capsules are equal). The hypothesis corresponded to the primary objective to show superior efficacy of pancrelipase delayed release capsules over placebo. A non-parametric ANCOVA was used because the necessary assumptions were not met for the parametric ANCOVA.||||<0.0001
70871306|NCT00601458|141227866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-65.4||||0.0001||97.8|-81.7|-34.6||1-sided alpha = 0.045 Hochberg closed testing procedure|ANOVA||The natural log scale treatment difference (naproxen - placebo) and 97.8% CI for the treatment difference were exponentiated and reported as a percentage reduction in 24-h cumulative hydromorphone consumption.|||-34.6|-81.7|0.0001
70871307|NCT00601458|141227867|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.46||||0.004||95.0|0.183|2.95||1-sided alpha = 0.045 Hochberg closed testing procedure|Log Rank||Hodges-Lehmann procedure was used to obtain an estimate of the difference in medians and an exact CI for the difference in medians|||2.95|0.183|0.004
70871308|NCT00601458|141227867|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.7|||<|0.001||95.0|1.77|6.72||1-sided alpha = 0.045 Hochberg closed testing procedure|Log Rank||Hodges-Lehmann procedure was used to obtain an estimate of the difference in medians and an exact CI for the difference in medians|||6.72|1.77|<0.001
70871309|NCT01288235|141227868|OTHER||3-Year Cumulative incidence|14.5|||||TWO_SIDED|95.0|8.3|22.3||||||||22.3|8.3|
70871310|NCT01288235|141227868|OTHER||5-Year Cumulative incidence|20.2|||||TWO_SIDED|95.0|12.7|28.9||||||||28.9|12.7|
70871311|NCT01288235|141227869|OTHER||Mean Difference (Net)|1.1||||0.543|TWO_SIDED|95.0|-2.6|4.9|||t-test, 2 sided|Paired t test||||4.9|-2.6|0.543
70871312|NCT01288235|141227870|OTHER||3-Year Local Disease Control Probability|89.9|||||TWO_SIDED|95.0|83.1|94.9||||||||94.9|83.1|
70871313|NCT01288235|141227870|OTHER||5-Year Local Disease Control Probability|85.9|||||TWO_SIDED|95.0|78.2|91.9||||||||91.9|78.2|
70871314|NCT01288235|141227870|OTHER||3-Year Distant Disease Control|97.0|||||TWO_SIDED|95.0|92.1|99.2||||||||99.2|92.1|
70871315|NCT01288235|141227870|OTHER||5-Year Distant Disease Control|95.0|||||TWO_SIDED|95.0|89.4|98.1||||||||98.1|89.4|
70871316|NCT01288235|141227871|OTHER||3-Year Cumulative incidence of grade 3+|12.2|||||TWO_SIDED|95.0|6.6|19.5||||||||19.5|6.6|
70871317|NCT01288235|141227871|OTHER||5-Year Cumulative incidence of grade 3+|16.3|||||TWO_SIDED|95.0|9.8|24.3||||||||24.3|9.8|
70871318|NCT01288235|141227872|OTHER||3-Year Cumulative inc. of hearing loss|12.5|||||TWO_SIDED|95.0|2.9|29.5||||||||29.5|2.9|
70871319|NCT01288235|141227872|OTHER||5-Year Cumulative inc. of hearing loss|12.5|||||TWO_SIDED|95.0|2.9|29.5||||||||29.5|2.9|
70871320|NCT01697566|141227873|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||Body Weight||||0.006
70871321|NCT01697566|141227873|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Fat Mass||||<0.001
70871322|NCT01697566|141227875|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||||||0.019
70871323|NCT02197130|141227923|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.52|STANDARD_ERROR_OF_MEAN|1.192||0.2033|TWO_SIDED|90.0|-0.45|3.49|||MMRM|MMRM: A linear mixed-effect repeated measures model||||3.49|-0.45|0.2033
70871324|NCT02197130|141227923|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35|STANDARD_ERROR_OF_MEAN|1.118||0.7549|TWO_SIDED|90.0|-2.2|1.5|||MMRM|||||1.50|-2.20|0.7549
70871325|NCT02197130|141227935|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.54|STANDARD_ERROR_OF_MEAN|0.515||0.003|TWO_SIDED|90.0|0.69|2.39|||MMRM|||Week 13||2.39|0.69|0.0030
70871326|NCT02197130|141227935|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.36|STANDARD_ERROR_OF_MEAN|0.491||0.4656|TWO_SIDED|90.0|-0.45|1.17|||MMRM|||Week 13||1.17|-0.45|0.4656
70871327|NCT02197130|141227935|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.21|STANDARD_ERROR_OF_MEAN|0.492||0.0149|TWO_SIDED|90.0|0.39|2.02|||MMRM|||Week 26||2.02|0.39|0.0149
70871328|NCT02197130|141227935|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.46||0.8233|TWO_SIDED|90.0|-0.66|0.86|||MMRM|||Week 26||0.86|-0.66|0.8233
70871329|NCT02197130|141227937|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.148||0.0181|TWO_SIDED|90.0|0.11|0.6|||MMRM|||Week 13||0.60|0.11|0.0181
70871330|NCT02197130|141227937|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.7133|TWO_SIDED|90.0|-0.18|0.28|||MMRM|||Week 13||0.28|-0.18|0.7133
70871331|NCT02197130|141227937|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.163||0.4657|TWO_SIDED|90.0|-0.15|0.39|||MMRM|||Week 26||0.39|-0.15|0.4657
70871332|NCT02197130|141227937|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.15||0.8339|TWO_SIDED|90.0|-0.22|0.28|||MMRM|||Week 26||0.28|-0.22|0.8339
70871333|NCT00980057|141228059|NON_INFERIORITY|The non-inferiority margin was 12%.||||||0.0002|||||||Farrington-Manning test of two ind. prop|||||||0.0002
70871334|NCT00980057|141228060|SUPERIORITY|The pre-specified minimum objective performance criteria was 0.82|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
70871335|NCT00980057|141228062|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70871336|NCT00980057|141228063|NON_INFERIORITY|The non-inferiority margin is 15|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
70871337|NCT00980057|141228064|NON_INFERIORITY|The non-inferiority margin is 2.5||||||0.0009|||||||t-test, 1 sided|||||||0.0009
70871338|NCT00980057|141228065|NON_INFERIORITY|The non-inferiority margin is 0.3|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
70871339|NCT00980057|141228066|NON_INFERIORITY|The non-inferiority margin is 30||||||0.0002|||||||t-test, 1 sided|||||||0.0002
70871340|NCT00980057|141228067|NON_INFERIORITY|The non-inferiority margin is 5.1||||||0.002|||||||t-test, 1 sided|||||||0.002
70871341|NCT02820753|141228076|SUPERIORITY||Mean Difference (Net)|0.26||||0.04|TWO_SIDED|95.0|0.01|0.51||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis||Treatment difference = (Text or Portal) - Enhanced Usual Care|||0.51|0.01|0.04
70871342|NCT02820753|141228077|SUPERIORITY||Mean Difference (Net)|0.04||||0.53|TWO_SIDED|95.0|-0.08|0.15||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis||Treatment Difference = (Text or Portal - Enhanced Usual Care|||0.15|-0.08|0.53
70871343|NCT02820753|141228078|SUPERIORITY||Mean Difference (Net)|-0.34||||0.41|TWO_SIDED|95.0|-1.16|0.48||The threshold for significance is p \< 0.05|Mixed Models Analysis||Treatment Difference = (Text or Portal) - Enhanced Usual Care|||0.48|-1.16|0.41
70871344|NCT02820753|141228079|SUPERIORITY||Mean Difference (Net)|1.83||||0.27|TWO_SIDED|95.0|-1.39|5.06||The threshold for significance is p \< 0.05|Mixed Models Analysis||Treatment difference = (Text or Portal ) - Enhanced Usual Care|||5.06|-1.39|0.27
70953757|NCT00414908|141409518|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Non parametric ANCOVA|||The following null hypothesis was tested (μ0 and μ1 denote the treatment group means respectively in the placebo and pancrelipase delayed release capsules group): H0: μ0 = μ1 (i.e., placebo and pancrelipase delayed release capsules are equal). The hypothesis corresponded to the primary objective to show superior efficacy of pancrelipase delayed release capsules over placebo. A non-parametric ANCOVA was used because the necessary assumptions were not met for the parametric ANCOVA.||||0.0002
70871345|NCT02820753|141228080|SUPERIORITY||Mean Difference (Net)|-0.23||||0.33|TWO_SIDED|95.0|-0.68|0.23||The threshold for significance is p \< 0.05|Mixed Models Analysis||Treatment Difference = (Text or Portal) - Enhanced Usual Care|||0.23|-0.68|0.33
70871346|NCT02128113|141228108|SUPERIORITY||LS Mean difference (Net)|26.95||||0.4529|TWO_SIDED||||||ANCOVA|Missing data were imputed.|Difference is Omaveloxolone Ophthalmic Suspension (pooled) - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension pooled (0.5% and 1.0%) versus Vehicle Ophthalmic Solution||||0.4529
70871347|NCT02128113|141228108|SUPERIORITY||LS Mean difference (Net)|64.31||||0.1276|TWO_SIDED||||||ANCOVA|Missing data were imputed.|Difference is Omaveloxolone Ophthalmic Suspension 0.5% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 0.5% versus Vehicle Ophthalmic Solution||||0.1276
70871348|NCT02128113|141228108|SUPERIORITY||LS Mean difference (Net)|-11.08||||0.7996|TWO_SIDED||||||ANCOVA|Missing data were imputed.|Difference is Omaveloxolone Ophthalmic Suspension 1.0% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 1.0% versus Vehicle Ophthalmic Solution||||0.7996
70871349|NCT02128113|141228109|SUPERIORITY||Difference in proportion of patients|-13.55||||0.0647|TWO_SIDED|95.0|-26.75|-0.36|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 0.5% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 0.5% versus Vehicle Ophthalmic Solution||-0.36|-26.75|0.0647
70871350|NCT02128113|141228109|SUPERIORITY||Difference in proportion of patients|-15.15||||0.0517|TWO_SIDED|95.0|-28.34|-1.96|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 1.0% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 1.0% versus Vehicle Ophthalmic Solution||-1.96|-28.34|0.0517
70871351|NCT02128113|141228110|SUPERIORITY||Difference in proportion of patients|-0.11||||0.9258|TWO_SIDED|95.0|-8.91|8.68|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 0.5% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 0.5% versus Vehicle Ophthalmic Solution||8.68|-8.91|0.9258
70871352|NCT02128113|141228110|SUPERIORITY||Difference in proportion of patients|-3.03||||0.6547|TWO_SIDED|95.0|-12.27|6.21|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 1.0% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 1.0% versus Vehicle Ophthalmic Solution||6.21|-12.27|0.6547
70871353|NCT02128113|141228111|SUPERIORITY||Difference in proportion of patients|-13.56||||0.0657|TWO_SIDED|95.0|-26.84|-0.28|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 0.5% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 0.5% versus Vehicle Ophthalmic Solution||-0.28|-26.84|0.0657
70871354|NCT02128113|141228111|SUPERIORITY|Comparison of Omaveloxolone Ophthalmic Suspension 1.0% versus Vehicle Ophthalmic Solution|Difference in proportion of patients|-15.15||||0.0526|TWO_SIDED|95.0|-28.42|-1.88|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 1.0% - Vehicle Ophthalmic Solution|||-1.88|-28.42|0.0526
70871355|NCT02128113|141228112|SUPERIORITY||Difference in proportion of patients|0.0||||0.8771|TWO_SIDED|95.0|-10.87|10.87|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 0.5% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 0.5% versus Vehicle Ophthalmic Solution||10.87|-10.87|0.8771
70871356|NCT02128113|141228112|SUPERIORITY||Difference in proportion of patients|1.35||||0.8248|TWO_SIDED|95.0|-9.32|12.02|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 1.0% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 1.0% versus Vehicle Ophthalmic Solution||12.02|-9.32|0.8248
70871357|NCT02128113|141228113|SUPERIORITY||LS Mean difference (Net)|27.21||||0.4686|TWO_SIDED||||||ANCOVA|Missing data were imputed.||Comparison of Omaveloxolone Ophthalmic Suspension pooled (0.5% and 1.0%) versus Vehicle Ophthalmic Solution||||0.4686
70871358|NCT02128113|141228113|SUPERIORITY||LS Mean difference (Net)|49.99||||0.2636|TWO_SIDED||||||ANCOVA|Missing data were imputed.||Comparison of Omaveloxolone Ophthalmic Suspension 0.5% versus Vehicle Ophthalmic Solution||||0.2636
70871359|NCT02128113|141228113|SUPERIORITY||LS Mean difference (Net)|-1.74||||0.9691|TWO_SIDED||||||ANCOVA|Missing data were imputed.||Comparison of Omaveloxolone Ophthalmic Suspension 1.0% versus Vehicle Ophthalmic Solution||||0.9691
70871360|NCT00370032|141228133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1||||0.131||95.0|-18.4|2.157|||paired t-test Hommel-Simes|||||2.157|-18.4|0.131
70871361|NCT00370032|141228133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.11||||0.131||95.0|-21.2|2.997|||paired t-test Hommel-Simes|||||2.997|-21.2|0.131
70871362|NCT02557555|141228155|OTHER|P-values corresponding to a test of equal proportions (yes/no- 50%/50%)|||||<|0.0001||||||Researched options for labor pain|Test of equal proportion (50/50)|||||||<0.0001
70871363|NCT02557555|141228155|OTHER|P-values corresponding to a test of equal proportions (yes/no- 50%/50%)|||||<|0.0001||||||Pamphlet better explained options for pain|Test of equal proportion (50/50)|||||||<0.0001
70871364|NCT02557555|141228155|OTHER||||||<|0.0001||||||Pamphlet should be given before onset labor pain|Test of equal proportion (50/50)|||||||<0.0001
70871365|NCT02557555|141228155|OTHER||||||<|0.0001||||||Pamphlet information helped to reduce anxiety|Test of equal proportion (50/50)|||||||<0.0001
70871366|NCT02557555|141228155|OTHER|||||||0.0002||||||Information corrected any misconception|Test of equal proportion (50/50)|||||||0.0002
70871367|NCT02557555|141228155|OTHER||||||<|0.0001||||||Written information should always be available|Test of equal proportion (50/50)|||||||<0.0001
70871368|NCT03129100|141228162|SUPERIORITY||Odds Ratio (OR)|4.35|||<|0.001|TWO_SIDED|95.0|2.03|9.35|||Regression, Logistic|||||9.35|2.03|<0.001
70871369|NCT03129100|141228163|SUPERIORITY||Odds Ratio (OR)|4.28||||0.003|TWO_SIDED|95.0|1.66|11.03|||Regression, Logistic|||||11.03|1.66|0.003
70871370|NCT03129100|141228163|SUPERIORITY||Odds Ratio (OR)|4.42||||0.001|TWO_SIDED|95.0|1.77|11.02|||Regression, Logistic|||||11.02|1.77|0.001
70871371|NCT03129100|141228165|SUPERIORITY||Odds Ratio (OR)|4.51||||0.001|TWO_SIDED|95.0|1.78|11.41|||Regression, Logistic|||||11.41|1.78|0.001
70871372|NCT03129100|141228165|SUPERIORITY||Odds Ratio (OR)|4.61|||<|0.001|TWO_SIDED|95.0|1.88|11.31|||Regression, Logistic|||||11.31|1.88|<0.001
70953758|NCT00414908|141409519|SUPERIORITY_OR_OTHER||LS Means difference|-112.45|||<|0.0001||95.0|-147.04|-77.87|||ANCOVA|||"The following null hypothesis was tested (μ0 and μ1 denote the treatment group means in the placebo and pancrelipase delayed release capsules group): H0: μ0 = μ1 (i.e., placebo and pancrelipase capsules are equal).~The hypothesis was to show superior efficacy of pancrelipase delayed release capsules over placebo.~For this secondary efficacy variable, an analysis of covariance (ANCOVA) model was assumed with the treatment group as a fixed factor and the Stool fat at baseline as a covariate."||-77.87|-147.04|<0.0001
70953759|NCT00414908|141409520|SUPERIORITY_OR_OTHER||LS Means difference|-11.68|||<|0.0001||95.0|-17.3|-6.06|||ANCOVA|||"The following null hypothesis was tested (μ0 and μ1 denote the treatment group means in the placebo and pancrelipase delayed release capsules group): H0: μ0 = μ1 (i.e., placebo and pancrelipase capsules are equal).~The hypothesis was to show superior efficacy of pancrelipase delayed release capsules over placebo. For this secondary efficacy variable, an analysis of covariance (ANCOVA) model was assumed with the treatment group as a fixed factor and the Stool nitrogen at baseline as a covariate."||-6.06|-17.30|<0.0001
70953760|NCT00414908|141409521|SUPERIORITY_OR_OTHER||LS Means difference|-0.76||||0.005||95.0|-1.27|-0.24|||ANCOVA|||"The following null hypothesis was tested (μ0 and μ1 denote the treatment group means in the placebo and pancrelipase delayed release capsules group): H0: μ0 = μ1 (i.e., placebo and pancrelipase capsules are equal). The hypothesis was to show superior efficacy of pancrelipase capsules over placebo.~For this secondary efficacy variable, an analysis of covariance (ANCOVA) model was assumed with the treatment group as a fixed factor and the Stool frequency at baseline as a covariate."||-0.24|-1.27|0.005
70953761|NCT00414908|141409525|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Paired t-test|Mean difference based on all subjects combined using the paired t-test between baseline and visit 8 or early termination||||||<0.001
70871373|NCT03129100|141228166|SUPERIORITY||Odds Ratio (OR)|5.17|||<|0.001|TWO_SIDED|95.0|2.11|12.69|||Regression, Logistic|||||12.69|2.11|<0.001
70871374|NCT03129100|141228166|SUPERIORITY||Odds Ratio (OR)|5.23|||<|0.001|TWO_SIDED|95.0|2.2|12.47|||Regression, Logistic|||||12.47|2.20|<0.001
70871375|NCT03129100|141228167|SUPERIORITY||Odds Ratio (OR)|4.6|||<|0.001|TWO_SIDED|95.0|1.9|11.17|||Regression, Logistic|||||11.17|1.90|<0.001
70871376|NCT03129100|141228167|SUPERIORITY||Odds Ratio (OR)|3.55||||0.003|TWO_SIDED|95.0|1.56|8.09|||Regression, Logistic|||||8.09|1.56|0.003
70871377|NCT03129100|141228168|SUPERIORITY||Odds Ratio (OR)|4.92|||<|0.001|TWO_SIDED|95.0|2.07|11.72|||Regression, Logistic|||||11.72|2.07|<0.001
70953762|NCT00921687|141409555|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.04|TWO_SIDED|95.0|1.01|2.3|||Generalized Estimating Equation||Intervention clinic (vs control clinic)|||2.30|1.01|0.04
70871378|NCT03129100|141228168|SUPERIORITY||Odds Ratio (OR)|3.61||||0.003|TWO_SIDED|95.0|1.57|8.32|||Regression, Logistic|||||8.32|1.57|0.003
70871379|NCT03129100|141228169|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|-3.1|-1.1|||ANCOVA|||Patient Global||-1.1|-3.1|<0.001
70871380|NCT03129100|141228169|SUPERIORITY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|-2.9|-1.0|||ANCOVA|||Patient Global||-1.0|-2.9|<0.001
70871381|NCT03129100|141228169|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|-3.1|-1.0|||ANCOVA|||Spinal Pain||-1.0|-3.1|<0.001
70871382|NCT03129100|141228169|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|-2.8|-0.8|||ANCOVA|||Spinal Pain||-0.8|-2.8|<0.001
70871383|NCT03129100|141228169|SUPERIORITY||LS Mean Difference|-1.55|STANDARD_ERROR_OF_MEAN|0.421|<|0.001|TWO_SIDED|95.0|-2.39|-0.72|||ANCOVA|||BASFI||-0.72|-2.39|<0.001
70871384|NCT03129100|141228169|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.409|<|0.001|TWO_SIDED|95.0|-2.2|-0.59|||ANCOVA|||BASFI||-0.59|-2.20|<0.001
70871385|NCT03129100|141228169|SUPERIORITY||LS Mean Difference|-2.17|STANDARD_ERROR_OF_MEAN|0.448|<|0.001|TWO_SIDED|95.0|-3.05|-1.28|||ANCOVA|||Inflammation||-1.28|-3.05|<0.001
70871386|NCT03129100|141228169|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.433|<|0.001|TWO_SIDED|95.0|-2.66|-0.95|||ANCOVA|||Inflammation||-0.95|-2.66|<0.001
70871387|NCT03129100|141228170|SUPERIORITY||Odds Ratio (OR)|5.34|||<|0.001|TWO_SIDED|95.0|2.13|13.35|||Regression, Logistic|||||13.35|2.13|<0.001
70871388|NCT03129100|141228170|SUPERIORITY||Odds Ratio (OR)|4.07||||0.001|TWO_SIDED|95.0|1.75|9.45|||Regression, Logistic|||||9.45|1.75|0.001
70871389|NCT03129100|141228171|SUPERIORITY||LS Mean Difference|-7.858|STANDARD_ERROR_OF_MEAN|1.9586|<|0.001|TWO_SIDED|95.0|-11.729|-3.987|||ANCOVA|||||-3.987|-11.729|<0.001
70871390|NCT03129100|141228171|SUPERIORITY||LS Mean Difference|-5.979|STANDARD_ERROR_OF_MEAN|1.86||0.002|TWO_SIDED|95.0|-9.655|-2.304|||ANCOVA|||||-2.304|-9.655|0.002
70871391|NCT03129100|141228172|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.104||0.062|TWO_SIDED|95.0|-0.4|0.01|||ANCOVA|||||0.01|-0.40|0.062
70871392|NCT03129100|141228172|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.099||0.018|TWO_SIDED|95.0|-0.43|-0.04|||ANCOVA|||||-0.04|-0.43|0.018
70871393|NCT03129100|141228173|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.335||0.757|TWO_SIDED|95.0|-0.56|0.77|||ANCOVA|||||0.77|-0.56|0.757
70871394|NCT03129100|141228173|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.322||0.67|TWO_SIDED|95.0|-0.77|0.5|||ANCOVA|||||0.50|-0.77|0.670
70871395|NCT03129100|141228174|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.338||0.236|TWO_SIDED|95.0|-1.07|0.27|||ANCOVA|||||0.27|-1.07|0.236
70953763|NCT00921687|141409556|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.44||95.0|0.84|1.49|||Generalized Estimating Equation||Intervention clinic (vs control clinic)|||1.49|0.84|0.44
70953764|NCT00316602|141409557|NON_INFERIORITY|The non-inferiority margin to show that Group 2 (Atopic Dermatitis Participants) is non-inferior to Group 1 (Healthy Participants) in terms of seroconversion rate at Week 6 was predefined as -5% for the difference in seroconversion rates.|Difference in seroconversion rates (%)|-1.2|||||ONE_SIDED|97.5|-4.3||||||||||-4.3|
70953765|NCT00626990|141409569|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.76|TWO_SIDED|99.1|0.73|1.28|||Regression, Cox|||||1.28|0.73|0.76
70953766|NCT00626990|141409569|SUPERIORITY||Hazard Ratio (HR)|0.64|||<|0.0001|TWO_SIDED|95.0|0.52|0.79|||Regression, Cox|||||0.79|0.52|<0.0001
70953767|NCT00626990|141409570|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.11|TWO_SIDED|95.0|0.72|1.03|||Regression, Cox|||||1.03|0.72|0.11
70953768|NCT00626990|141409570|SUPERIORITY||Hazard Ratio (HR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.49|0.7|||Regression, Cox|||||0.70|0.49|<0.0001
70953769|NCT01008410|141409603|SUPERIORITY|||||||0.0324||||||Threshold for significance at 0.05 level.|Regression, Logistic|||The logistic regression test was used to test for a difference in the percentages between the 2 treatment arms after adjusting for analysis center (country).||||0.0324
70953770|NCT00297427|141409619|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||||||0.02
70953771|NCT00297427|141409620|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||t-test, 2 sided|||||||0.32
70871396|NCT03129100|141228174|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.319||0.373|TWO_SIDED|95.0|-0.92|0.35|||ANCOVA|||||0.35|-0.92|0.373
70871397|NCT03129100|141228175|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.459||0.885|TWO_SIDED|95.0|-0.98|0.85|||ANCOVA|||||0.85|-0.98|0.885
70871398|NCT03129100|141228175|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.41||0.735|TWO_SIDED|95.0|-0.95|0.68|||ANCOVA|||||0.68|-0.95|0.735
70871399|NCT03129100|141228176|SUPERIORITY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.501||0.294|TWO_SIDED|95.0|-1.53|0.47|||ANCOVA|||||0.47|-1.53|0.294
70871400|NCT03129100|141228176|SUPERIORITY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.453||0.164|TWO_SIDED|95.0|-1.54|0.27|||ANCOVA|||||0.27|-1.54|0.164
70871401|NCT03129100|141228177|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|1.1||0.063|TWO_SIDED|95.0|-4.3|0.1|||ANCOVA|||||0.1|-4.3|0.063
70871402|NCT03129100|141228177|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|1.02||0.211|TWO_SIDED|95.0|-3.3|0.7|||ANCOVA|||||0.7|-3.3|0.211
70953772|NCT00297427|141409621|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.16
70953773|NCT00297427|141409622|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.18
70953774|NCT00297427|141409624|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.04
70953775|NCT00297427|141409625|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.38
70953776|NCT00297427|141409626|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.43
70953777|NCT00297427|141409628|SUPERIORITY_OR_OTHER|||||||0.04|||||||Repeated measures using GEE|||||||0.04
70953778|NCT00297427|141409629|SUPERIORITY_OR_OTHER|||||||0.01|||||||Repeated measures using GEE|||||||0.01
70953779|NCT00297427|141409630|SUPERIORITY_OR_OTHER|||||||0.41|||||||Repeated measures using GEE|||||||0.41
70953780|NCT00297427|141409631|SUPERIORITY_OR_OTHER|||||||0.04||||||Bivariate (unadjusted) analysis|t-test, 2 sided|||||||0.04
70953781|NCT00297427|141409631|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.208||||0.014|TWO_SIDED|95.0|1.039|1.405|||Regression, Logistic||These are the adjusted results of a multivariate logistic regression.|||1.405|1.039|0.014
70953782|NCT00297427|141409632|SUPERIORITY_OR_OTHER|||||||0.023||||||This is the result from the bivariate (unadjusted) analysis.|t-test, 2 sided|||||||0.023
70953783|NCT00297427|141409632|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.936||||0.03|TWO_SIDED|95.0|0.881|0.994|||Regression, Logistic||These are the adjusted results from a multivariate logistic regression analysis.|||0.994|0.881|0.030
70871403|NCT03129100|141228178|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.9||0.334|TWO_SIDED|95.0|-2.7|0.9|||ANCOVA|||||0.9|-2.7|0.334
70871404|NCT03129100|141228178|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.88||0.168|TWO_SIDED|95.0|-3.0|0.5|||ANCOVA|||||0.5|-3.0|0.168
70953784|NCT00297427|141409633|SUPERIORITY_OR_OTHER|||||||0.64|||||||t-test, 2 sided|||||||0.64
70953785|NCT00297427|141409634|SUPERIORITY_OR_OTHER|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
70953786|NCT00297427|141409636|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<.001
70953787|NCT00297427|141409637|SUPERIORITY_OR_OTHER|||||||0.48|||||||t-test, 2 sided|||||||0.48
70953788|NCT00297427|141409638|SUPERIORITY_OR_OTHER|||||||0.86|||||||t-test, 2 sided|||||||0.86
70953789|NCT03248882|141409645|SUPERIORITY||Mean Difference (Net)|-10.7|||||TWO_SIDED|80.0|-19.4|-1.1||||||||-1.1|-19.4|
70953790|NCT03248882|141409645|SUPERIORITY||Mean Difference (Net)|-46.0|||||TWO_SIDED|80.0|-51.3|-40.1||||||||-40.1|-51.3|
70953791|NCT03248882|141409645|SUPERIORITY||Mean Difference (Net)|-52.4|||||TWO_SIDED|80.0|-57.2|-47.1||||||||-47.1|-57.2|
70953792|NCT03248882|141409645|SUPERIORITY||Mean Difference (Net)|-62.1|||||TWO_SIDED|80.0|-66.0|-57.8||||||||-57.8|-66.0|
70953793|NCT03248882|141409646|SUPERIORITY||Mean Difference (Net)|-4.4|||||TWO_SIDED|80.0|-14.0|6.3||||||||6.3|-14.0|
70953794|NCT03248882|141409646|SUPERIORITY||Mean Difference (Net)|-21.0|||||TWO_SIDED|80.0|-29.0|-12.2||||||||-12.2|-29.0|
70953795|NCT03248882|141409646|SUPERIORITY||Mean Difference (Net)|-25.0|||||TWO_SIDED|80.0|-32.8|-16.1||||||||-16.1|-32.8|
70871405|NCT03129100|141228180|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.4||0.1|TWO_SIDED|95.0|-1.5|0.1|||ANCOVA|||||0.1|-1.5|0.100
70871406|NCT03129100|141228180|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.38||0.047|TWO_SIDED|95.0|-1.5|0.0|||ANCOVA|||||-0.0|-1.5|0.047
70871407|NCT03129100|141228181|SUPERIORITY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.479||0.068|TWO_SIDED|95.0|-1.83|0.06|||ANCOVA|||||0.06|-1.83|0.068
70871408|NCT03129100|141228181|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.465||0.307|TWO_SIDED|95.0|-1.4|0.44|||ANCOVA|||||0.44|-1.40|0.307
70871409|NCT03129100|141228182|SUPERIORITY||LS Mean Difference|2.6021|STANDARD_ERROR_OF_MEAN|1.4684||0.079|TWO_SIDED|95.0|-0.3011|5.5053|||ANCOVA|||||5.5053|-0.3011|0.079
70871410|NCT03129100|141228182|SUPERIORITY||LS Mean Difference|2.4096|STANDARD_ERROR_OF_MEAN|1.3978||0.087|TWO_SIDED|95.0|-0.3541|5.1734|||ANCOVA|||||5.1734|-0.3541|0.087
71145436|NCT00286468|141784940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||<|0.001|TWO_SIDED|95.0|-0.59|-0.19||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for glycosylated hemoglobin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at week 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=500 subjects had 94% power to detect a treatment difference as small as 0.4% in the supportive per-protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level, and \>=80% of subjects meeting per protocol criteria.||-0.19|-0.59|<0.001
71145437|NCT00286468|141784940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|||<|0.001|TWO_SIDED|95.0|-0.73|-0.33||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at week 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=500 subjects had 94% power to detect a treatment difference as small as 0.4% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level and \>=80% of subjects meeting per-protocol criteria.||-0.33|-0.73|<0.001
71145438|NCT00286468|141784941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|||<|0.001|TWO_SIDED|95.0|-0.33|-0.13||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.13|-0.33|<0.001
71145439|NCT00286468|141784941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|||<|0.001|TWO_SIDED|95.0|-0.38|-0.18||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.18|-0.38|<0.001
71145440|NCT00286468|141784942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||<|0.001|TWO_SIDED|95.0|-0.53|-0.26||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.26|-0.53|<0.001
71145441|NCT00286468|141784942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||<|0.001|TWO_SIDED|95.0|-0.61|-0.33||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.33|-0.61|<0.001
71145442|NCT00286468|141784943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|||<|0.001|TWO_SIDED|95.0|-0.57|-0.25||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.25|-0.57|<0.001
71145443|NCT00286468|141784943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|||<|0.001|TWO_SIDED|95.0|-0.68|-0.36||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.36|-0.68|<0.001
71145444|NCT00286468|141784944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|||<|0.001|TWO_SIDED|95.0|-0.54|-0.19||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.19|-0.54|<0.001
71145445|NCT00286468|141784944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||<|0.001|TWO_SIDED|95.0|-0.68|-0.33||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.33|-0.68|<0.001
70953796|NCT03248882|141409646|SUPERIORITY||Mean Difference (Net)|-41.8|||||TWO_SIDED|80.0|-47.9|-35.0||||||||-35.0|-47.9|
70953797|NCT01305408|141409734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.2717|TWO_SIDED|95.0|-3.76|1.06||Statistical tests were 2-tailed at the 0.05 level of significance.|mixed-model repeated measures (MMRM)|Treatment, visit, treatment-by-visit interaction, concurrent mood-stabilizing medication, and region of the world used as fixed factors.||||1.06|-3.76|0.2717
70953798|NCT00799981|141409796|OTHER|||||||0.8762|||||||Wilcoxon (Mann-Whitney)|||The hypothesis that a 10 cm catheter provides equal emptying of the bladder as a 7 cm catheter was tested.||||0.8762
70953799|NCT00799981|141409797|OTHER|||||||0.7905|||||||McNemar|||||||0.7905
70953800|NCT00799981|141409798|OTHER|||||||1|||||||McNemar|||||||1.00
70953801|NCT00799981|141409801|OTHER|||||||0.0273|||||||Wilcoxon (Mann-Whitney)|||In the table 0=No and 1=Yes.||||0.0273
70953802|NCT03653208|141409809|OTHER||Slope|1.01||||0.1075|TWO_SIDED|90.0|||||Kruskal-Wallis|||||||0.1075
70953803|NCT03653208|141409810|OTHER||Slope|1.2||||0.0548|TWO_SIDED|90.0|||||Kruskal-Wallis|||||||0.0548
70953804|NCT03752970|141409878|OTHER||Risk Difference (RD)|-0.609|||||TWO_SIDED|95.0|-0.88|-0.186||||||||-0.186|-0.880|
70953805|NCT03752970|141409879|OTHER||Risk Difference (RD)|-0.509|||||TWO_SIDED|95.0|-0.816|-0.087||||||||-0.087|-0.816|
70953806|NCT03752970|141409880|OTHER||Risk Difference (RD)|-0.509|||||TWO_SIDED|95.0|-0.816|-0.087||||||||-0.087|-0.816|
71145446|NCT00286468|141784945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|||<|0.001|TWO_SIDED|95.0|-0.54|-0.17||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.17|-0.54|<0.001
71145447|NCT00286468|141784945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|||<|0.001|TWO_SIDED|95.0|-0.71|-0.34||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.34|-0.71|<0.001
71145448|NCT00286468|141784946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.1||||0.006|TWO_SIDED|95.0|-20.8|-3.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-3.4|-20.8|0.006
71145449|NCT00286468|141784946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.3|||<|0.001|TWO_SIDED|95.0|-28.0|-10.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.6|-28.0|<0.001
71145450|NCT00286468|141784947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9|||<|0.001|TWO_SIDED|95.0|-22.5|-7.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-7.2|-22.5|<0.001
71145451|NCT00286468|141784947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.0|||<|0.001|TWO_SIDED|95.0|-27.7|-12.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-12.4|-27.7|<0.001
71145452|NCT00286468|141784948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9||||0.01|TWO_SIDED|95.0|-19.3|-2.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-2.6|-19.3|0.010
71145453|NCT00286468|141784948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.4|||<|0.001|TWO_SIDED|95.0|-25.8|-9.1||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.1|-25.8|<0.001
71145454|NCT00286468|141784949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.7|||<|0.001|TWO_SIDED|95.0|-25.2|-8.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.2|-25.2|<0.001
71145455|NCT00286468|141784949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.4|||<|0.001|TWO_SIDED|95.0|-23.9|-6.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-6.9|-23.9|<0.001
71145456|NCT00286468|141784950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.1||||0.03|TWO_SIDED|95.0|-19.2|-1.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-1.0|-19.2|0.030
71145457|NCT00286468|141784950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.7||||0.012|TWO_SIDED|95.0|-20.8|-2.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-2.5|-20.8|0.012
71145458|NCT00286468|141784951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.701|TWO_SIDED|95.0|-11.6|7.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.8|-11.6|0.701
71145459|NCT00286468|141784951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0||||0.228|TWO_SIDED|95.0|-15.7|3.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.7|-15.7|0.228
70953807|NCT01669577|141409901|SUPERIORITY_OR_OTHER||GEE(Generalyzed Estimation Equation)|0.989214|||<|0.001|TWO_SIDED|95.0|0.982855|0.995613||arterial hemoglobin Oxygen saturation|ANOVA|Non parametric(NPar) ANOVA|GEE model (dichotomous response variable)with logit link function. The NPar ANOVA (p\<0.1 for death) was the test used for inclusion in the model variables for the final models - backward method, with alpha equal to 0.05.|"significance level of 0.05, power of 0.80, moderate correlation of 0.5 between time periods and assumption that the variability is equal within each factor (non-sphericity). Due to the effect size between 0.1 and 0.5, there was no need for samples larger than 140 patients. A total of 200 patients was defined conservatively, with a margin for possible deaths. The software G\*Power 3.1.7 was used for sample size calculation.~Fischer's test, Mann-Whitney, t-test; Non parametric ANOVA and GEE"||0.995613|0.982855|< 0.001
70953808|NCT01669577|141409901|SUPERIORITY_OR_OTHER||GEE|0.99728|||<|0.001|TWO_SIDED|95.0|0.995791|0.998772|||ANOVA|||diastolic arterial blood pressure||0.998772|0.995791|< 0.001
70953809|NCT01669577|141409901|SUPERIORITY_OR_OTHER||GEE|1.046961|||<|0.004|TWO_SIDED|95.0|1.012521|1.082572|||ANOVA|||lactate||1.082572|1.012521|< 0.004
70953810|NCT01669577|141409901|SUPERIORITY_OR_OTHER||GEE|0.973987|||<|0.001|TWO_SIDED|95.0|0.965308|0.982744|||ANOVA|||Glasgow coma score||0.982744|0.965308|<0.001
71145460|NCT00286468|141784952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0||||0.097|TWO_SIDED|95.0|-19.6|1.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.6|-19.6|0.097
71145461|NCT00286468|141784952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.3||||0.014|TWO_SIDED|95.0|-23.9|-2.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-2.7|-23.9|0.014
71145462|NCT00286468|141784953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.8||||0.241|TWO_SIDED|95.0|-18.3|4.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.6|-18.3|0.241
71145463|NCT00286468|141784953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.5||||0.072|TWO_SIDED|95.0|-22.0|0.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.9|-22.0|0.072
71145464|NCT00286468|141784954|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.775||||0.338|TWO_SIDED|95.0|0.46|1.306||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||1.306|0.460|0.338
71145465|NCT00286468|141784954|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.521||||0.016|TWO_SIDED|95.0|0.306|0.887||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.887|0.306|0.016
71145466|NCT00286468|141784955|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.374||||0.003|TWO_SIDED|95.0|0.194|0.72||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.720|0.194|0.003
71145467|NCT00286468|141784955|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.372||||0.003|TWO_SIDED|95.0|0.193|0.718||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.718|0.193|0.003
71145468|NCT00286468|141784956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.923|TWO_SIDED|95.0|-6.1|6.7||No multiplicity adjustments.|Regression, Logistic|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.7|-6.1|0.923
71145469|NCT00286468|141784956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7||||0.259|TWO_SIDED|95.0|-2.7|10.1||No multiplicity adjustments.|Regression, Logistic|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||10.1|-2.7|0.259
71145470|NCT00286468|141784957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.916|TWO_SIDED|95.0|-6.6|5.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.9|-6.6|0.916
71145471|NCT00286468|141784957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3||||0.305|TWO_SIDED|95.0|-3.0|9.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||9.5|-3.0|0.305
71145472|NCT00286468|141784958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.953|TWO_SIDED|95.0|-6.1|5.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.8|-6.1|0.953
71145473|NCT00286468|141784958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.957|TWO_SIDED|95.0|-6.1|5.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.8|-6.1|0.957
71145474|NCT00286468|141784959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.908|TWO_SIDED|95.0|-5.9|6.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.6|-5.9|0.908
71145475|NCT00286468|141784959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.826|TWO_SIDED|95.0|-5.6|7.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.0|-5.6|0.826
71145476|NCT00286468|141784960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.894|TWO_SIDED|95.0|-5.9|6.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.8|-5.9|0.894
71145477|NCT00286468|141784960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.432|TWO_SIDED|95.0|-3.8|8.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||8.9|-3.8|0.432
71145478|NCT00286468|141784961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.548|TWO_SIDED|95.0|-8.1|4.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.3|-8.1|0.548
71145479|NCT00286468|141784961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.986|TWO_SIDED|95.0|-6.3|6.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.2|-6.3|0.986
71145480|NCT00286468|141784962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26||||0.415|TWO_SIDED|95.0|-1.78|4.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.30|-1.78|0.415
71145481|NCT00286468|141784962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51||||0.332|TWO_SIDED|95.0|-1.54|4.55||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.55|-1.54|0.332
71145482|NCT00286468|141784963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.89|TWO_SIDED|95.0|-2.47|2.85||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.85|-2.47|0.890
71145483|NCT00286468|141784963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.19||||0.38|TWO_SIDED|95.0|-1.48|3.86||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.86|-1.48|0.380
71145484|NCT00286468|141784964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.35||||0.448|TWO_SIDED|95.0|-2.14|4.85||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.85|-2.14|0.448
71145485|NCT00286468|141784964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02||||0.568|TWO_SIDED|95.0|-2.48|4.52||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.52|-2.48|0.568
71145486|NCT00286468|141784965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.95||||0.077|TWO_SIDED|95.0|-0.32|6.22||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.22|-0.32|0.077
70871411|NCT03129100|141228183|SUPERIORITY||LS Mean Difference|0.837|STANDARD_ERROR_OF_MEAN|1.1752||0.477|TWO_SIDED|95.0|-1.4864|3.1605|||ANCOVA|||||3.1605|-1.4864|0.477
70871412|NCT03129100|141228183|SUPERIORITY||LS Mean Difference|2.3009|STANDARD_ERROR_OF_MEAN|1.1192||0.042|TWO_SIDED|95.0|0.088|4.5138|||ANCOVA|||||4.5138|0.0880|0.042
71145487|NCT00286468|141784965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.72||||0.303|TWO_SIDED|95.0|-1.55|4.99||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.99|-1.55|0.303
70871413|NCT03129100|141228184|SUPERIORITY||LS Mean Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.52||0.058|TWO_SIDED|95.0|-2.02|0.04|||ANCOVA|||||0.04|-2.02|0.058
70871414|NCT03129100|141228184|SUPERIORITY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.497||0.147|TWO_SIDED|95.0|-1.71|0.26|||ANCOVA|||||0.26|-1.71|0.147
70871415|NCT03129100|141228185|SUPERIORITY||LS Mean Difference|0.0418|STANDARD_ERROR_OF_MEAN|0.0334||0.213|TWO_SIDED|95.0|-0.0329|0.1164|||ANCOVA|||||0.1164|-0.0329|0.213
70871416|NCT03129100|141228185|SUPERIORITY||LS Mean Difference|0.0388|STANDARD_ERROR_OF_MEAN|0.0319||0.225|TWO_SIDED|95.0|-0.0324|0.1101|||ANCOVA|||||0.1101|-0.0324|0.225
70871417|NCT03129100|141228186|SUPERIORITY||LS Mean Difference|-10.62|STANDARD_ERROR_OF_MEAN|4.383||0.017|TWO_SIDED|95.0|-19.28|-1.95|||ANCOVA|||Percentage of Activity Impairment||-1.95|-19.28|0.017
70871418|NCT03129100|141228186|SUPERIORITY||LS Mean Difference|-7.14|STANDARD_ERROR_OF_MEAN|4.199||0.091|TWO_SIDED|95.0|-15.44|1.16|||ANCOVA|||Percentage of Activity Impairment||1.16|-15.44|0.091
70871419|NCT03129100|141228187|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.66||0.531|TWO_SIDED|95.0|-1.7|0.9|||ANCOVA|||||0.9|-1.7|0.531
70871420|NCT03129100|141228187|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.62||0.743|TWO_SIDED|95.0|-1.4|1.0|||ANCOVA|||||1.0|-1.4|0.743
70871421|NCT03845985|141228190|SUPERIORITY|||||||0.838||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.838
70871422|NCT03845985|141228191|SUPERIORITY|||||||0.62||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.620
70871423|NCT03845985|141228192|SUPERIORITY|||||||0.713||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.713
70871424|NCT03845985|141228193|SUPERIORITY|||||||0.509||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.509
70871425|NCT03845985|141228194|SUPERIORITY|||||||0.491||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.491
70871426|NCT03845985|141228195|SUPERIORITY|||||||0.715||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.715
71145488|NCT00286468|141784966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25||||0.461|TWO_SIDED|95.0|-2.08|4.57||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.57|-2.08|0.461
70871427|NCT03845985|141228196|SUPERIORITY|||||||0.665||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.665
70871428|NCT03845985|141228197|SUPERIORITY|||||||0.875||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.875
70871429|NCT03845985|141228198|SUPERIORITY|||||||0.61||||||Analysis was significantly underpowered.|t-test, 2 sided|||Comparison of the Risk and Aggression/Liquid Courage/Sociability Subscale||||.610
70871430|NCT03845985|141228198|SUPERIORITY|||||||0.658||||||Analysis was significantly underpowered.|t-test, 2 sided|||Comparison of the Self-Perception/Cognitive and Behavioral Impairment Subscale||||.658
70871431|NCT03845985|141228198|SUPERIORITY|||||||1||||||Analysis was significantly underpowered.|t-test, 2 sided|||Comparison of the Sexuality Subscale||||1.000
70871432|NCT03845985|141228198|SUPERIORITY|||||||0.007||||||Analysis was significantly underpowered.|t-test, 2 sided|||Comparison of the Tension Reduction Subscale||||.007
70871433|NCT03845985|141228199|SUPERIORITY|||||||0.407||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.407
70871434|NCT03845985|141228200|SUPERIORITY|||||||0.893||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.893
70871435|NCT03845985|141228201|SUPERIORITY|||||||0.709||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.709
70871436|NCT03334539|141228207|SUPERIORITY||Least Squares (LS) Mean Difference|0.11||||0.3378|TWO_SIDED|95.0|-0.12|0.34||P-value was calculated using a model with treatment, baseline score, and site as covariates.|ANCOVA|||||0.34|-0.12|0.3378
70871437|NCT03334539|141228207|SUPERIORITY||LS Mean Difference|0.12||||0.2883|TWO_SIDED|95.0|-0.1|0.35||P-value was calculated using a model with treatment, baseline score, and site as covariates.|ANCOVA|||||0.35|-0.10|0.2883
70871438|NCT03334539|141228207|OTHER||LS Mean Difference|0.01||||0.9293|TWO_SIDED|95.0|-0.22|0.24||P-value calculated using a model with treatment, baseline score, and site as covariates|ANCOVA|||||0.24|-0.22|0.9293
70871439|NCT03334539|141228208|SUPERIORITY||LS Mean Difference|-0.3||||0.1473|TWO_SIDED|95.0|-0.7|0.1||P-value calculated using a model with treatment, baseline score, and site as covariates.|ANCOVA|||||0.1|-0.7|0.1473
70871440|NCT03334539|141228208|SUPERIORITY||LS Mean Difference|-0.3||||0.2321|TWO_SIDED|95.0|-0.7|0.2||P-value calculated using a model with treatment, baseline score, and site as covariates.|ANCOVA|||||0.2|-0.7|0.2321
70871441|NCT03334539|141228208|OTHER||LS Mean Difference|0.0||||0.8217|TWO_SIDED|95.0|-0.4|0.5||P-value calculated using a model with treatment, baseline score, and site as covariates.|ANCOVA|||||0.5|-0.4|0.8217
70871442|NCT03736447|141228251|SUPERIORITY||Risk Difference (RD)|67.2|||<|0.0001|TWO_SIDED|95.0|50.0|84.5|||Farrington-Manning test|||||84.5|50.0|<0.0001
70871443|NCT03736447|141228252|SUPERIORITY||Risk Difference (RD)|64.2|||<|0.0001|TWO_SIDED|95.0|47.0|81.4|||Farrington-Manning test|||||81.4|47.0|<0.0001
70871444|NCT03736447|141228253|SUPERIORITY||Risk Difference (RD)|56.7|||<|0.0001|TWO_SIDED|95.0|39.8|73.5|||Farrington-Manning test|||||73.5|39.8|<0.0001
70871445|NCT04974697|141228287|SUPERIORITY|The superiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold 40 points for myope.|Least-square Mean|58.1|STANDARD_ERROR_OF_MEAN|3.37|||TWO_SIDED|95.0|50.9|65.4|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||It was calculated using a 2-sided one sample means t-test with a family wise type I error rate of 5% and at least 80% statistical power, that 22 subjects were required to test superiority for myope.||65.4|50.9|
70871446|NCT04974697|141228287|SUPERIORITY|The superiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold 32 points for hyperope.|Least-square Mean|55.0|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|47.2|62.8|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||It was calculated using a 2-sided one sample means t-test with a family wise type I error rate of 5% and at least 80% statistical power, that 18 subjects were required to test superiority for hyperope.||62.8|47.2|
70953811|NCT01669577|141409901|SUPERIORITY_OR_OTHER||GEE|1.000013|||<|0.023|TWO_SIDED|95.0|1.0|1.000025|||ANOVA|||amount of Infused crystalloids||1.000025|1.000000|<0.023
71145489|NCT00286468|141784966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99||||0.559|TWO_SIDED|95.0|-2.34|4.32||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.32|-2.34|0.559
70871447|NCT04974697|141228288|SUPERIORITY|The superiority of the Test lens was concluded if the upper credible limit of the mean was below the pre-defined threshold 0.00 logMAR for Distance.|Least-square Mean|-0.129|STANDARD_ERROR_OF_MEAN|0.0166|||TWO_SIDED|95.0|-0.167|-0.091|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||It was calculated by using a 2-sided one sample mean t-test with a family wise type I error rate of 5% and at least 80% statistical power , 42 subjects were required to test superiority for distance (4m).||-0.091|-0.167|
71145490|NCT00286468|141784967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04||||0.43|TWO_SIDED|95.0|-1.54|3.62||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.62|-1.54|0.430
70953812|NCT02045875|141409923|SUPERIORITY|||||||0.046||||||Effect of interaction of time and treatment group|ANOVA|||||||0.046
71145491|NCT00286468|141784967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03||||0.124|TWO_SIDED|95.0|-0.56|4.61||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.61|-0.56|0.124
71145492|NCT00286468|141784968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.056||||0.011|TWO_SIDED|95.0|-0.099|-0.013||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.013|-0.099|0.011
71145493|NCT00286468|141784968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.035||||0.116|TWO_SIDED|95.0|-0.078|0.009||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.009|-0.078|0.116
71145494|NCT00286468|141784969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044||||0.024|TWO_SIDED|95.0|-0.081|-0.006||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.006|-0.081|0.024
71145495|NCT00286468|141784969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.037||||0.059|TWO_SIDED|95.0|-0.074|0.001||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.001|-0.074|0.059
71145496|NCT00286468|141784970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.028||||0.159|TWO_SIDED|95.0|-0.067|0.011||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.011|-0.067|0.159
71145497|NCT00286468|141784970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.038||||0.055|TWO_SIDED|95.0|-0.077|0.001||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.001|-0.077|0.055
71145498|NCT00286468|141784971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039||||0.062|TWO_SIDED|95.0|-0.08|0.002||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.002|-0.080|0.062
71145499|NCT00286468|141784971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.043||||0.041|TWO_SIDED|95.0|-0.084|-0.002||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.002|-0.084|0.041
71145500|NCT00286468|141784972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.148|TWO_SIDED|95.0|-0.069|0.01||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.010|-0.069|0.148
71145501|NCT00286468|141784972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.031||||0.135|TWO_SIDED|95.0|-0.071|0.009||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.009|-0.071|0.135
70953813|NCT02045875|141409924|OTHER||correlation coefficient|-0.508|||||TWO_SIDED||||||||correlation of asthma control and adherence|||||
70871448|NCT04974697|141228288|SUPERIORITY|The superiority of the Test lens was concluded if the upper credible limit of the mean was below the pre-defined threshold +0.17 logMAR for Intermediate.|Least-square Mean|-0.046|STANDARD_ERROR_OF_MEAN|0.0166|||TWO_SIDED|95.0|-0.084|-0.008|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||It was calculated by using a 2-sided one sample mean t-test with a family wise type I error rate of 5% and at least 80% statistical power , 7 subjects were required to test superiority for intermediate (64 cm).||-0.008|-0.084|
71145502|NCT00286468|141784973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.026||||0.177|TWO_SIDED|95.0|-0.065|0.012||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.012|-0.065|0.177
71145503|NCT00286468|141784973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.026||||0.177|TWO_SIDED|95.0|-0.065|0.012||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.012|-0.065|0.177
71145504|NCT00286468|141784974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162||||0.324|TWO_SIDED|95.0|-0.161|0.486||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.486|-0.161|0.324
71145505|NCT00286468|141784974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176||||0.284|TWO_SIDED|95.0|-0.147|0.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.500|-0.147|0.284
71145506|NCT00286468|141784975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.268||||0.053|TWO_SIDED|95.0|-0.004|0.54||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.540|-0.004|0.053
71145507|NCT00286468|141784975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.349||||0.012|TWO_SIDED|95.0|0.077|0.621||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.621|0.077|0.012
71145508|NCT00286468|141784976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182||||0.196|TWO_SIDED|95.0|-0.094|0.458||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.458|-0.094|0.196
71145509|NCT00286468|141784976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226||||0.11|TWO_SIDED|95.0|-0.051|0.502||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.502|-0.051|0.110
71145510|NCT00286468|141784977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.228||||0.121|TWO_SIDED|95.0|-0.06|0.517||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.517|-0.060|0.121
71145511|NCT00286468|141784977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159||||0.28|TWO_SIDED|95.0|-0.13|0.448||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.448|-0.130|0.280
71145512|NCT00286468|141784978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.015||||0.924|TWO_SIDED|95.0|-0.29|0.32||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.320|-0.290|0.924
71145513|NCT00286468|141784978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138||||0.376|TWO_SIDED|95.0|-0.168|0.444||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.444|-0.168|0.376
70871449|NCT04974697|141228288|SUPERIORITY|The superiority of the Test lens was concluded if the upper credible limit of the mean was below the pre-defined threshold +0.17 logMAR for Near.|Least-square Mean|0.067|STANDARD_ERROR_OF_MEAN|0.0166|||TWO_SIDED|95.0|0.029|0.105|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||It was calculated by using a 2-sided one sample mean t-test with a family wise type I error rate of 5% and at least 80% statistical power , 36 subjects were required to test superiority for near (40 cm).||0.105|0.029|
71145514|NCT00286468|141784979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075||||0.642|TWO_SIDED|95.0|-0.242|0.393||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.393|-0.242|0.642
71145515|NCT00286468|141784979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.063||||0.698|TWO_SIDED|95.0|-0.255|0.381||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.381|-0.255|0.698
71145516|NCT00286468|141784980|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.596|TWO_SIDED|95.0|0.503|3.306||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||3.306|0.503|0.596
71145517|NCT00286468|141784980|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96||||0.148|TWO_SIDED|95.0|0.787|4.885||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||4.885|0.787|0.148
71145518|NCT00286468|141784981|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.925||||0.046|TWO_SIDED|95.0|1.011|3.666||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||3.666|1.011|0.046
71145519|NCT00286468|141784981|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.505||||0.005|TWO_SIDED|95.0|1.313|4.78||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||4.780|1.313|0.005
71145520|NCT00286468|141784982|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.955||||0.025|TWO_SIDED|95.0|1.086|3.519||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||3.519|1.086|0.025
71145521|NCT00286468|141784982|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.707|||<|0.001|TWO_SIDED|95.0|2.012|6.831||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||6.831|2.012|<0.001
71145522|NCT00286468|141784983|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.994|||<|0.001|TWO_SIDED|95.0|1.72|5.213||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||5.213|1.720|<0.001
71145523|NCT00286468|141784983|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.401|||<|0.001|TWO_SIDED|95.0|1.95|5.933||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||5.933|1.950|<0.001
71145524|NCT00286468|141784984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.776||||0.115|TWO_SIDED|95.0|0.87|3.627||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||3.627|0.870|0.115
71145525|NCT00286468|141784984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.416|||<|0.001|TWO_SIDED|95.0|1.703|6.851||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||6.851|1.703|<0.001
71145526|NCT00286468|141784985|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.991||||0.986|TWO_SIDED|95.0|0.365|2.689||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||2.689|0.365|0.986
71145527|NCT00286468|141784985|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05||||0.131|TWO_SIDED|95.0|0.808|5.203||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||5.203|0.808|0.131
71145528|NCT00286468|141784986|SUPERIORITY_OR_OTHER|||||||0.626||95.0||||no multiplicity adjustments|Mantel Haenszel|OR and 95% CI not estimable using logistic regression model. Tested using extended Mantel-Haenszel test.||||||0.626
71145529|NCT00286468|141784986|SUPERIORITY_OR_OTHER|||||||0.178||||||no multiplicity adjustments|Mantel Haenszel|OR and 95% CI not estimable using logistic regression model. Tested using extended Mantel-Haenszel test.||||||0.178
71145530|NCT00286468|141784987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|||<|0.001|TWO_SIDED|95.0|0.32|1.16||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.16|0.32|<0.001
71145531|NCT00286468|141784987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.006|TWO_SIDED|95.0|0.17|1.02||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.02|0.17|0.006
71145532|NCT00286468|141784988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69||||0.006|TWO_SIDED|95.0|0.2|1.18||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.18|0.20|0.006
71145533|NCT00286468|141784988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.04|TWO_SIDED|95.0|0.02|1.01||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.01|0.02|0.040
71145534|NCT00286468|141784989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|||<|0.001|TWO_SIDED|95.0|0.47|1.73||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.73|0.47|<0.001
71145535|NCT00286468|141784989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91||||0.005|TWO_SIDED|95.0|0.28|1.55||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.55|0.28|0.005
71145536|NCT00286468|141784990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.018|TWO_SIDED|95.0|0.14|1.46||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.46|0.14|0.018
71145537|NCT00286468|141784990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.88||||0.01|TWO_SIDED|95.0|0.21|1.54||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.54|0.21|0.010
71145538|NCT02923726|141784991|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.005|TWO_SIDED|95.9|0.57|0.92|||Log Rank||Shock only was the reference group. Confidence interval adjusted for interim analyses.|||0.92|0.57|0.005
71145539|NCT02923726|141784992|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.284|TWO_SIDED|95.0|0.78|1.07|||Log Rank||Shock Only was the reference group.|||1.07|0.78|0.284
70871450|NCT04974697|141228289|NON_INFERIORITY|The non-inferiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold -5 points for myope.|Least-square Mean|8.4|STANDARD_ERROR_OF_MEAN|2.66|||TWO_SIDED|95.0|3.1|13.7|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||The study was only powered for the primary endpoint.||13.7|3.1|
71145540|NCT02923726|141784993|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.02|TWO_SIDED|95.0|0.56|0.95|||Log Rank||Shock Only arm is reference group.|||0.95|0.56|0.020
71145541|NCT02923726|141784994|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.033|TWO_SIDED|95.0|0.44|0.97|||Log Rank||Shock Only is the reference group.|||0.97|0.44|0.033
71145542|NCT02923726|141784995|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.184|TWO_SIDED|95.0|0.94|1.41|||Log Rank||Shock Only is the reference group.|||1.41|0.94|0.184
71145543|NCT03324607|141784996|OTHER|||||||0.006|||||||Paired t-test|||||||0.006
71145544|NCT00129402|141785029|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||95.0|||||ANOVA|||||||<0.01
71145545|NCT00129402|141785030|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||95.0|||||ANOVA|||||||<0.01
71145546|NCT00129402|141785031|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||95.0|||||ANOVA|||||||<0.01
71145547|NCT00129402|141785032|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48||95.0|||||non-parametric model|||||||.48
71145548|NCT00129402|141785033|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||95.0|||||ANOVA|||||||<0.01
71145549|NCT00129402|141785034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.95||95.0|||||ANOVA|||||||.95
71145550|NCT02992288|141785065|SUPERIORITY|||||||0.2297||||||Linear dose-response shape: The multiple comparison procedures (MCP) approach was applied to calculate the adjusted one-sided one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.2297
71145551|NCT02992288|141785065|SUPERIORITY|||||||0.4409||||||Sigmoidal Emax 1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.4409
71145552|NCT02992288|141785065|SUPERIORITY|||||||0.2842||||||Sigmoidal Emax 2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.2842
71145553|NCT02992288|141785065|SUPERIORITY|||||||0.2534||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.2534
71145554|NCT02992288|141785065|SUPERIORITY|||||||0.3842||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.3842
71145555|NCT02992288|141785066|SUPERIORITY|||||||0.8966||||||Linear dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.8966
71145556|NCT02992288|141785066|SUPERIORITY|||||||0.9233||||||Sigmoidal Emax 1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9233
71145557|NCT02992288|141785066|SUPERIORITY|||||||0.9296||||||Sigmoidal Emax 2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9296
71145558|NCT02992288|141785066|SUPERIORITY|||||||0.7357||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.7357
70953814|NCT01204710|141409940|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.29||||0.2201|TWO_SIDED|95.0|0.87|1.9||Analysis was stratified by the randomization stratification factor: best overall response to prior docetaxel-based chemotherapy.|Log Rank||Hazard ratio is expressed as IMC-3G3 + Mitoxantrone / Mitoxantrone and estimated from Cox model.|||1.90|0.87|0.2201
70953815|NCT01204710|141409941|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.08||||0.7291|TWO_SIDED|95.0|0.72|1.61||Analysis was stratified by the randomization stratification factor: best overall response to prior docetaxel-based chemotherapy.|Log Rank||Hazard ratio is expressed as Olaratumab + Mitoxantrone / Mitoxantrone and estimated from Cox model.|||1.61|0.72|0.7291
70953816|NCT01204710|141409942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3465|TWO_SIDED||||||Fisher Exact|||||||0.3465
70953817|NCT01204710|141409943|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6571|TWO_SIDED||||||Fisher Exact|||||||0.6571
70953818|NCT01204710|141409944|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4986|TWO_SIDED||||||Fisher Exact|||||||0.4986
70953819|NCT02001064|141409999|SUPERIORITY||Odds Ratio (OR)|2.3||||0.32|TWO_SIDED||||||t-test, 1 sided|||||||0.32
71145559|NCT02992288|141785066|SUPERIORITY|||||||0.9083||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9083
71145560|NCT02992288|141785067|SUPERIORITY|||||||0.4596||||||Linear dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.4596
70953820|NCT02001064|141410000|SUPERIORITY|||||||0.073||||||Cohen's d (ranks) = -.049|Wilcoxon (Mann-Whitney)|||||||0.073
70953821|NCT02001064|141410001|SUPERIORITY|||||||0.24||||||Cohen's d=0.31|Wilcoxon (Mann-Whitney)|||||||0.24
70953822|NCT00515723|141410028|SUPERIORITY|||||||0.002||||||The a priori threshold for statistical significance in this planned primary test was p\<0.05.|Mixed Models Analysis|||Primary analysis for change in DEXA total fat used a likelihood-based mixed-effects model using time (0, 6, and 12 weeks) as the independent variable, with Toeplitz covariance structure specified, based on Akaike Information Criterion-Corrected (AIC-C). The null hypothesis was that there was no difference in the outcome over time (main effect of time).||||0.002
70953823|NCT00515723|141410028|SUPERIORITY|||||||0.002||||||The a priori threshold for statistical significance in this planned primary test was p\<0.05.|Mixed Models Analysis|||Primary analysis for change in DEXA total fat used a likelihood-based mixed-effects model using time (0, 6, and 12 weeks) and treatment group as independent variables, with Toeplitz covariance structure specified, based on Akaike Information Criterion-Corrected (AIC-C). The null hypothesis was that there were no differences between groups in the change over time (time by treatment condition).||||0.002
71145561|NCT02992288|141785067|SUPERIORITY|||||||0.7859||||||Sigmoidal Emax1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.7859
71145562|NCT02992288|141785067|SUPERIORITY|||||||0.5562||||||Sigmoidal Emax2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.5562
71145563|NCT02992288|141785067|SUPERIORITY|||||||0.5338||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.5338
70953824|NCT00515723|141410029|SUPERIORITY|||||||0.05||||||The a priori threshold for statistical significance in this planned primary test was p\<0.05.|Mixed Models Analysis|||Primary analysis for change in insulin sensitivity used a likelihood-based mixed-effects model using time (0 and 12 weeks) as the independent variable, with an unstructured covariance structure specified, based on the Akaike Information Criterion-Corrected (AIC-C). The null hypothesis was that there was no difference in the outcome over time (main effect of time).||||0.05
70953825|NCT00515723|141410029|SUPERIORITY|||||||0.22||||||The a priori threshold for statistical significance in this planned primary test was p\<0.05.|Mixed Models Analysis|||Primary analysis for change in insulin sensitivity used a likelihood-based mixed-effects model using time (0 and 12 weeks) and treatment group as the independent variables, with an unstructured covariance structure specified, based on the Akaike Information Criterion-Corrected (AIC-C). The null hypothesis was that there were no differences between groups in the change over time (time by treatment condition).||||0.22
70953826|NCT02626455|141410031|SUPERIORITY|Comparison of PFS|Hazard Ratio (HR)|1.125|||=|0.827974|TWO_SIDED|95.0|0.881|1.437||Significance level is 0.025.|Log Rank|PFS was evaluated with a one-sided stratified log- rank test. HR and 95% CI are based on the stratified Cox regression model.||||1.437|0.881|= 0.827974
70953827|NCT02626455|141410034|SUPERIORITY|ORR of Copa+R-B/R-CHOP minus ORR of Pbo+R-B/R-CHOP|Difference|-1.25|||=|0.658652|TWO_SIDED|95.0|-7.25|4.75||Significance level is 0.025. P-values are descriptive (nominal) due to multiplicity testing.|Cochran-Mantel-Haenszel|Point estimate and 95% CI are based on Mantel-Haenszel weighted treatment difference.||||4.75|-7.25|= 0.658652
70953828|NCT02626455|141410035|SUPERIORITY|ORR of Copa+R-B/R-CHOP minus ORR of Pbo+R-B/R-CHOP|Difference|-0.8|||=|0.605183|TWO_SIDED|95.0|-6.64|5.05||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Cochran-Mantel-Haenszel|Point estimate and 95% CI are based on Mantel-Haenszel weighted treatment difference.||||5.05|-6.64|=0.605183
71145564|NCT02992288|141785067|SUPERIORITY|||||||0.7303||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.7303
70953829|NCT02626455|141410036|SUPERIORITY|Comparison of DOR|Hazard Ratio (HR)|1.145|||=|0.846204|TWO_SIDED|95.0|0.883|1.484||Significance level is 0.025, P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|DOR was evaluated with a one-sided stratified log-rank test. HR and its 95% CI were based on the stratified Cox regression model.||||1.484|0.883|= 0.846204
70953830|NCT02626455|141410037|SUPERIORITY|Comparison of DOR|Hazard Ratio (HR)|1.117|||=|0.801735|TWO_SIDED|95.0|0.865|1.443||Significance level is 0.025, P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|DOR was evaluated with a one-sided stratified log-rank test. HR and its 95% CI were based on the stratified Cox regression model.||||1.443|0.865|= 0.801735
70953831|NCT02626455|141410038|SUPERIORITY|CRR of Copa+R-B/R-CHOP minus CRR of Pbo+R-B/R-CHOP|Difference|-2.74|||=|0.741153|TWO_SIDED|95.0|-11.06|5.57||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Cochran-Mantel-Haenszel|Point estimate and 95% CI are based on Mantel-Haenszel weighted treatment difference.||||5.57|-11.06|= 0.741153
70953832|NCT02626455|141410039|SUPERIORITY|CRR of Copa+R-B/R-CHOP minus CRR of Pbo+R-B/R-CHOP|Difference|-2.21|||=|0.696482|TWO_SIDED|95.0|-10.62|6.2||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Cochran-Mantel-Haenszel|Point estimate and 95% CI are based on Mantel-Haenszel weighted treatment difference.||||6.20|-10.62|= 0.696482
71145565|NCT02992288|141785068|SUPERIORITY|||||||0.5703||||||Linear dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.5703
70953833|NCT02626455|141410040|SUPERIORITY|DCR of Copa+R-B/R-CHOP minus DCR of Pbo+R-B/R-CHOP|Difference|-3.95|||=|0.936009|TWO_SIDED|95.0|-9.04|1.14||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Cochran-Mantel-Haenszel|Point estimate and 95% CI are based on Mantel-Haenszel weighted treatment difference||||1.14|-9.04|= 0.936009
70953834|NCT02626455|141410041|SUPERIORITY|DCR of Copa+R-B/R-CHOP minus DCR of Pbo+R-B/R-CHOP|Difference|-3.89|||=|0.944242|TWO_SIDED|95.0|-8.68|0.9||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Cochran-Mantel-Haenszel|Point estimate and 95% CI are based on Mantel-Haenszel weighted treatment difference||||0.90|-8.68|= 0.944242
70953835|NCT02626455|141410042|SUPERIORITY|Comparison of TTP|Hazard Ratio (HR)|1.006|||=|0.517849|TWO_SIDED|95.0|0.777|1.303||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|TTP was evaluated with a one-sided stratified log-rank test. HR and its 95% CI are based on the stratified Cox regression model.||||1.303|0.777|= 0.517849
70953836|NCT02626455|141410043|SUPERIORITY|Comparison of TTP|Hazard Ratio (HR)|0.971|||=|0.411398|TWO_SIDED|95.0|0.75|1.257||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|TTP was evaluated with a one-sided stratified log-rank test. HR and its 95% CI are based on the stratified Cox regression model.||||1.257|0.750|= 0.411398
70953837|NCT02626455|141410044|SUPERIORITY|Comparison of TTNT|Hazard Ratio (HR)|1.289|||=|0.955865|TWO_SIDED|95.0|0.962|1.728||Significance level IS 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|TTNT was evaluated with a one-sided stratified log-rank test. HR and its 95% CI are based on the stratified Cox regression model.||||1.728|0.962|= 0.955865
70953838|NCT02626455|141410045|SUPERIORITY|Comparison of OS|Hazard Ratio (HR)|1.132|||=|0.758563|TWO_SIDED|95.0|0.8|1.603||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|OS was evaluated with a one-sided stratified log-rank test. HR and 95% CI are based on the stratified Cox regression model.||||1.603|0.800|= 0.758563
70953839|NCT02626455|141410046|SUPERIORITY|Comparison of time to deterioration in DRS-P|Hazard Ratio (HR)|1.394|||=|0.999695|TWO_SIDED|95.0|1.149|1.691||Significance level IS 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|Time to deterioration in DRS-P was evaluated with one-sided stratified log-rank test.HR and its 95% CI are based on stratified Cox regression model.||||1.691|1.149|= 0.999695
70953840|NCT02626455|141410047|SUPERIORITY|Comparison of time to improvement in DRS-P|Hazard Ratio (HR)|0.81|||=|0.965639|TWO_SIDED|95.0|0.642|1.02||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|Time to improvement in DRS-P was evaluated with one-sided stratified log-rank test.HR and its 95% CI are based on the stratified Cox regression model.||||1.020|0.642|= 0.965639
70953841|NCT01882543|141410051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.061|TWO_SIDED|95.0|-2.1|0.0|||ANCOVA|||A sample size of 28 subjects per group had 80% power to detect a 1.5-point difference in the change from baseline pain score between AQX-1125 and placebo assuming a between-subject SD of 2.0 and a 2-sided 5% significance level. Average daily pain scores were calculated using an average of up to the last 7 recordings within 9 days before each visit. Missing data, including premature discontinuation, was imputed using the LOCF approach for the primary efficacy end point of average daily pain score||0.0|-2.1|0.061
70953842|NCT01882543|141410052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.03|TWO_SIDED|95.0|-2.5|-0.1|||ANCOVA|||E-diary maximum daily pain scores were calculated using an average of up to the last 7 recordings within 9 days before each visit. Missing data, including premature discontinuation, was imputed using the LOCF approach for the secondary efficacy variable of maximum daily pain score||-0.1|-2.5|0.030
70953843|NCT01882543|141410053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.008|TWO_SIDED|95.0|-2.8|-0.5|||ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||-0.5|-2.8|0.008
70953844|NCT01882543|141410054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.028|TWO_SIDED|95.0|-3.0|-0.2|||ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||-0.2|-3.0|0.028
70953845|NCT01882543|141410055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.4||||0.011|TWO_SIDED|95.0|-9.5|-1.3|||ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||-1.3|-9.5|0.011
70953846|NCT01882543|141410056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1||||0.007|TWO_SIDED|95.0|-8.8|-1.4||ICSI/PI|ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||-1.4|-8.8|0.007
70953847|NCT01882543|141410056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.005|TWO_SIDED|95.0|-4.6|-0.9||ICSI|ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||-0.9|-4.6|0.005
70953848|NCT01882543|141410056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.014|TWO_SIDED|95.0|-4.5|-0.5||ICPI|ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||-0.5|-4.5|0.014
70953849|NCT01882543|141410057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.592|TWO_SIDED|95.0|-6.3|3.6||Mental Component|ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||3.6|-6.3|0.592
70953850|NCT01882543|141410057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.221|TWO_SIDED|95.0|-1.6|6.7||Physical Component|ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||6.7|-1.6|0.221
70953851|NCT01882543|141410058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.04|TWO_SIDED|95.0|-5.5|-0.1|||ANOVA|||Analyses of the secondary variable was based on observed data without imputation.||-0.1|-5.5|0.040
70953852|NCT00926497|141410072|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Fisher Exact|||The trial was designed to obtain a power of 90% to detect a 30% difference between the two groups in the duration of antibiotic therapy with an estimated standard deviation of 50%.||||0.002
70953853|NCT00926497|141410073|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||t-test, 2 sided|||||||0.012
70953854|NCT00926497|141410073|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.004
70953855|NCT00128102|141410082|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.858|TWO_SIDED|95.0|0.83|1.17|||Log Rank|||||1.17|0.83|0.858
70953856|NCT00128102|141410086|SUPERIORITY||Hazard Ratio (HR)|0.75|||<|0.001|TWO_SIDED|95.0|0.63|0.88|||Likelihood Based Score Test|||||0.88|0.63|<0.001
70953857|NCT00128102|141410087|SUPERIORITY||Difference in Percentage|0.3||||0.621|TWO_SIDED|95.0|-1.18|1.97|||Fisher Exact|||||1.97|-1.18|0.621
70953858|NCT00128102|141410088|SUPERIORITY||Difference in Percent Change|-52.4||||0.259|TWO_SIDED|95.0|-143.5|38.6|||Longitudinal Model|||||38.6|-143.5|0.259
70953859|NCT00128102|141410089|SUPERIORITY||Difference in Percentage|-1.3||||0.736|TWO_SIDED|95.0|-7.2|4.53|||Fisher Exact|||||4.53|-7.20|0.736
70953860|NCT00128102|141410090|SUPERIORITY||Difference in Percent Change|-0.06||||0.979|TWO_SIDED|95.0|-4.61|4.49|||Longitudinal Model|||||4.49|-4.61|0.979
70953861|NCT00128102|141410091|SUPERIORITY||Difference in Percentage|3.1||||0.488|TWO_SIDED|95.0|-4.97|11.17|||Fisher Exact|||||11.17|-4.97|0.488
70953862|NCT01006252|141410175|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.121||95.0||||Statistical significance was assessed at an alpha level of 0.05.|Stratified log rank|||||||0.121
70953863|NCT01006252|141410176|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.048||95.0||||Statistical significance was assessed at an alpha level of 0.05.|Stratified log rank|Analysis adjusted for Baseline Lactate Dehydrogenase (LDH); Disease Stage; Sex; Previous Single Agent Immunotherapy Treatment; Age Group||||||0.048
70953864|NCT01006252|141410177|SUPERIORITY_OR_OTHER|||||||0.396||95.0||||Statistical significance was assessed at an alpha level of 0.05.|Unadjusted normal distribution|Unadjusted normal-distribution approximation for the difference in rates||||||0.396
70953865|NCT01006252|141410179|SUPERIORITY_OR_OTHER|||||||0.483||95.0||||Statistical significance was assessed at an alpha level of 0.05.|Unadjusted normal distribution|Unadjusted normal-distribution approximation for the difference in rates.||||||0.483
70953866|NCT01006252|141410180|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.505||95.0||||Statistical significance was assessed at an alpha level of 0.05.|Stratified log rank|||||||0.505
70953867|NCT01006252|141410181|SUPERIORITY_OR_OTHER|||||||0.902||95.0||||P-value given for Overall Main Treatment Effect from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.902
70953868|NCT01006252|141410181|SUPERIORITY_OR_OTHER|||||||0.97||95.0||||P-value given for Treatment-By-Cycle Interaction from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.970
70953869|NCT01006252|141410183|SUPERIORITY_OR_OTHER|||||||0.902||95.0||||P-value given for Overall Main Treatment Effect from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.902
70953870|NCT01006252|141410183|SUPERIORITY_OR_OTHER|||||||0.97||95.0||||P-value given for Overall Treatment-By-Cycle Interaction from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.970
70953871|NCT01006252|141410184|SUPERIORITY_OR_OTHER|||||||0.547||95.0||||P-value given for Main Treatment Effect from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.547
70953872|NCT01006252|141410184|SUPERIORITY_OR_OTHER|||||||0.414||95.0||||P-value given for Treatment-By-Cycle Interaction from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.414
70953873|NCT01006252|141410186|SUPERIORITY_OR_OTHER|||||||0.547||95.0||||P-value given for Main Treatment Effect from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.547
70953874|NCT01006252|141410186|SUPERIORITY_OR_OTHER|||||||0.414||95.0||||P-value given for Treatment-By-Cycle Interaction from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.414
70953875|NCT02683772|141410211|NON_INFERIORITY|The method proposed for this analysis was a one-sided paired t-test using a significance level of 0.05 and a non-inferiority margin of 2 events/hour|Mean Difference (Final Values)|-4.45|STANDARD_DEVIATION|17.23||0.0134|TWO_SIDED||||||t-test, 1 sided|||||||0.0134
70953876|NCT00574873|141410226|SUPERIORITY_OR_OTHER|||||||0.667||||||p-value was based on a Cochran Mantel Haenszel test for general association between treatment and responder stratification by Sokal risk group (low, intermediate, high) and region (1 to 3) as determined at time of randomization.|Stratified Cochran-Mantel-Haenszel|||||||0.667
70871451|NCT04974697|141228289|NON_INFERIORITY|The non-inferiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold -5 points for hyperope.|Least-square Mean|5.0|STANDARD_ERROR_OF_MEAN|3.12|||TWO_SIDED|95.0|-1.2|11.2|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||The study was only powered for the primary endpoint.||11.2|-1.2|
70953877|NCT00574873|141410227|SUPERIORITY_OR_OTHER|||||||0.002||||||p-value was based on a Cochran Mantel Haenszel test for general association between treatment and responder stratification by Sokal risk group (low, intermediate, high) and region (1 to 3) as determined at time of randomization.|Stratified Cochran-Mantel-Haenszel|||||||0.002
70953878|NCT00574873|141410228|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.31|1.31|||||Hazard ratio (95% confidence interval) based on the treatment effect (bosutinib compared with imatinib) in a stratified (by Sokal risk group and region at randomization) Cox model for the hazard of the respective event.|||1.31|0.31|
70953879|NCT00574873|141410229|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.32|1.08|||||Hazard ratio (95% confidence interval) based on the treatment effect (bosutinib compared with imatinib) in a stratified (by Sokal risk group and region at randomization) Cox model for the hazard of the respective event.|||1.08|0.32|
70953880|NCT00574873|141410230|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.25|||||TWO_SIDED|95.0|0.9|11.72|||||Hazard ratio (95% confidence interval) based on the treatment effect (bosutinib compared with imatinib) in a stratified (by Sokal risk group and region at randomization) Cox model for the hazard of the respective event.|||11.72|0.90|
70953881|NCT00574873|141410231|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41|||||TWO_SIDED|95.0|0.13|1.29|||||The hazard ratio (95% confidence interval) is obtained from a Cox model for cause-specific hazard as a function of the covariate treatment (bosutinib compared with imatinib) with stratification by region and Sokal risk group at randomization.|||1.29|0.13|
70953882|NCT00201643|141410234|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.45|STANDARD_ERROR_OF_MEAN|0.1162||0.002|TWO_SIDED|95.0|0.27|0.75||Analysis were also conducted in all randomized women with a known outcome \& in randomized treatment group(modified intent to treat). Analysis of the primary outcome used a repeated measures approach where each baby was considered a repeated measure|Fisher Exact|||Our Hypothesis was that administration of a rescue ACS would show a 40% reduction in incidence of composite neonatal morbity in patients delivering \< 34 weeks. Sample size estimates based on composite morbidity of 28%. Each arm required 217 subjects to have 80% power to detect a 40% reduction to 16.8%(2-tailed,alpha =0.05)using comparison for proportions/groups(Fisher exact test) OR,95% CI \& P values were determined using a repeated measure model where each twin is considered a repeat measure.||0.75|0.27|0.002
70953883|NCT02787044|141410265|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.21|TWO_SIDED|95.0|0.97|1.17|||Regression, Cox|||Note, each participant can be included in the primary analysis up to 3 times (participating seasons).||1.17|0.97|0.21
70953884|NCT02787044|141410266|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.44|TWO_SIDED|95.0|0.94|1.15|||Regression, Cox|||||1.15|0.94|0.44
70953885|NCT02787044|141410267|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.16|TWO_SIDED|95.0|0.97|1.2|||Regression, Cox|||Each participant can be analyzed up to three times (seasons)||1.2|.97|0.16
70953886|NCT02787044|141410268|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.26|TWO_SIDED|95.0|0.96|1.15|||Regression, Cox|||||1.15|.96|0.26
70871452|NCT04974697|141228290|NON_INFERIORITY|The non-inferiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold -5 points for myope.|Least-square Mean|6.9|STANDARD_ERROR_OF_MEAN|3.44|||TWO_SIDED|95.0|0.0|13.7|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||The study was only powered for the primary endpoint.||13.7|0.0|
70871453|NCT04974697|141228290|NON_INFERIORITY|The non-inferiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold -5 points for hyperope.|Least-square Mean|3.3|STANDARD_ERROR_OF_MEAN|4.03|||TWO_SIDED|95.0|-4.7|11.3|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||The study was only powered for the primary endpoint.||11.3|-4.7|
70871454|NCT04974697|141228291|NON_INFERIORITY|The non-inferiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold -5 points for myope.|Least-square Mean|11.2|STANDARD_ERROR_OF_MEAN|3.11|||TWO_SIDED|95.0|5.0|17.4|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||The study was only powered for the primary endpoint.||17.4|5.0|
70953887|NCT02787044|141410269|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.96|TWO_SIDED|95.0|0.84|1.21|||Regression, Cox|||||1.21|0.84|0.96
70953888|NCT02040584|141410282|SUPERIORITY_OR_OTHER|||||||0.9423|||||||Fisher Exact|Week 52||"Null hypothesis (H0): there were no differences in kidney function between the two groups, in contrast with the alternative hypothesis (H1), in which there were differences:~HO: CBS = CBC versus H1: CBS ≠ CBC, where CBS and CBC were percentages of patients who showed clinical benefit at Week 52 for the study group and control group, respectively."||||0.9423
70953889|NCT05540717|141410293|SUPERIORITY||relative difference (%)|-20.25||||0.00048|TWO_SIDED|95.0|-31.0|-9.49|||Mixed Models Analysis|||Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect||-9.49|-31.0|0.00048
70953890|NCT05540717|141410294|SUPERIORITY||relative difference (%)|-20.2||||0.00032|TWO_SIDED|95.0|-30.13|-10.27|||Mixed Models Analysis|Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect||Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect||-10.27|-30.13|0.00032
70953891|NCT05540717|141410295|SUPERIORITY|Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect|relative difference (%)|-26.54||||0.0008|TWO_SIDED|95.0|-41.15|-11.94|||Mixed Models Analysis|||Comparison of dMS of CSMS on peak GPS||-11.94|-41.15|0.00080
70953892|NCT05540717|141410295|SUPERIORITY|Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect.|relative difference (%)|-26.6||||0.00031|TWO_SIDED|95.0|-40.49|-12.72|||Mixed Models Analysis|||Comparison of dMS of CSMS on entire GPS||-12.72|-40.49|0.00031
70953893|NCT05540717|141410296|SUPERIORITY|Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect|relative difference (%)|-16.35||||0.00223|TWO_SIDED|95.0|-26.27|-6.44|||Mixed Models Analysis|||Comparison of dSS of CSMS on peak GPS||-6.44|-26.27|0.00223
70953894|NCT05540717|141410296|SUPERIORITY|Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect|relative difference (%)|-16.58||||0.00076|TWO_SIDED|95.0|||||Mixed Models Analysis|||Comparison of dSS of CSMS on entire GPS||||0.00076
70953895|NCT05540717|141410297|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.00032|TWO_SIDED|95.0|-0.76|-0.23|||Mixed Models Analysis|Linear mixed model using treatment group as fixed effect, Baseline total RQLQ score as covariate and pooled geographical region as random effect||Average Total RQLQ Score During Peak GPS||-0.23|-0.76|0.00032
70953896|NCT05540717|141410298|SUPERIORITY||Mean Difference (Final Values)|3.99|||<|1e-05|TWO_SIDED|95.0|3.28|4.7|||Mixed Models Analysis|||Change from baseline to Visit 7 of serum grass-specific IgG4 \[mg/L\]||4.7|3.28|<0.00001
70871455|NCT04974697|141228291|NON_INFERIORITY|The non-inferiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold -5 points for hyperope.|Least-square Mean|10.0|STANDARD_ERROR_OF_MEAN|3.64|||TWO_SIDED|95.0|2.8|17.3|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||The study was only powered for the primary endpoint.||17.3|2.8|
70871456|NCT03302234|141228323|OTHER||Hazard Ratio (HR)|1.08||||0.74156|TWO_SIDED|95.0|0.85|1.37||One-sided p-value based on log-rank test stratified by ECOG, geographic region of the enrolling site, and predominant tumor history.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, geographic region of the enrolling site, and predominant tumor history.|||1.37|0.85|0.74156
70871457|NCT03302234|141228324|OTHER||Hazard Ratio (HR)|1.06||||0.7172|TWO_SIDED|95.0|0.86|1.3|||Log Rank|One-sided p-value based on log-rank test stratified by ECOG, geographic region of the enrolling site, and predominant tumor history.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, geographic region of the enrolling site and predominant tumor history.|||1.30|0.86|0.71720
70953897|NCT05540717|141410299|SUPERIORITY||Odds Ratio (OR)|1.254||||0.10846|TWO_SIDED|95.0|0.951|1.652|||Regression, Logistic|The probability of a well day was calculated using a generalized estimating equation (GEE) or similar approaches as appropriate.||Probability of Well Days During Peak (truncated) GPS||1.652|0.951|0.10846
70953898|NCT01470001|141410319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.7||||0.1135|TWO_SIDED|95.0|-4.3|39.7|||Mixed Models Analysis|mixed model with repeated measurements||A planned sample size of 56 subjects per group provided 80% power to detect a difference of 0.25 between post void dribbling response rates (assumed to be 0.35 under the null hypothesis and 0.60 under the alternative hypothesis) at a one-sided 0.05 significance level.||39.7|-4.3|.1135
70871458|NCT03302234|141228325|OTHER||Difference in percentage|-0.1||||0.50644|TWO_SIDED|95.0|-8.2|8.1|||Miettinen & Nurminen method|One-sided p-value for testing|Based on Miettinen \& Nurminen method stratified by ECOG, geographic region of the enrolling site and predominant tumor history.|||8.1|-8.2|0.50644
70953899|NCT01470001|141410320|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.3||||0.0919|TWO_SIDED|95.0|-2.3|30.8|||Regression, Logistic|logistic regression with repeated measurements||||30.8|-2.3|.0919
70871459|NCT03302234|141228327|OTHER||Hazard Ratio (HR)|0.9815||||0.9112|TWO_SIDED|95.0|0.7386|1.3042|||Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, geographic region of the enrolling site, and predominant tumor histology.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, geographic region of the enrolling site, and predominant tumor histology.|||1.3042|0.7386|0.9112
71145566|NCT02992288|141785068|SUPERIORITY|||||||0.8253||||||Sigmoidal Emax1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.8253
71145567|NCT02992288|141785068|SUPERIORITY|||||||0.6506||||||Sigmoidal Emax2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.6506
71145568|NCT02992288|141785068|SUPERIORITY|||||||0.6923||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.6923
71145569|NCT02992288|141785068|SUPERIORITY|||||||0.8036||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.8036
71145570|NCT02992288|141785069|SUPERIORITY|||||||0.9955||||||Linear dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9955
71145571|NCT02992288|141785069|SUPERIORITY|||||||0.9946||||||Sigmoidal Emax1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9946
71145572|NCT02992288|141785069|SUPERIORITY|||||||0.9913||||||Sigmoidal Emax2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9913
71145573|NCT02992288|141785069|SUPERIORITY|||||||0.9982||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9982
71145574|NCT02992288|141785069|SUPERIORITY|||||||0.9959||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9959
71145575|NCT03416985|141785073|OTHER|||||||0.1561||||||p \< 0.05 considered significant|ANOVA|||Compare groups with respect to plaque level after 30 days||||0.1561
71145576|NCT03416985|141785074|OTHER|||||||0.2161||||||p \< 0.05 considered significant|ANOVA|||Compare groups with respect to Gingival scores at 30 days||||0.2161
71145577|NCT02006472|141785075|SUPERIORITY||LSM difference|1.42||||0.3202|TWO_SIDED|95.0|-1.39|4.23|||Mixed Models Analysis|||||4.23|-1.39|0.3202
71145578|NCT02006472|141785075|SUPERIORITY||LSM difference|1.7||||0.2266|TWO_SIDED|95.0|-1.06|4.46|||Mixed Models Analysis|||||4.46|-1.06|0.2266
71145579|NCT02006472|141785075|SUPERIORITY||LSM difference|0.66||||0.6348|TWO_SIDED|95.0|-2.07|3.39|||Mixed Models Analysis|||||3.39|-2.07|0.6348
71145580|NCT02006472|141785075|SUPERIORITY||LSM difference|2.04||||0.1447|TWO_SIDED|95.0|-0.71|4.8|||Mixed Models Analysis|||||4.8|-0.71|0.1447
71145581|NCT02006472|141785077|SUPERIORITY||LSM difference|0.87||||0.0032|TWO_SIDED|95.0|0.29|1.45|||Mixed Models Analysis|||||1.45|0.29|0.0032
71145582|NCT02006472|141785077|SUPERIORITY||LSM difference|0.11||||0.7042|TWO_SIDED|95.0|-0.46|0.68|||Mixed Models Analysis|||||0.68|-0.46|0.7042
71145583|NCT02006472|141785077|SUPERIORITY||LSM difference|0.19||||0.5099|TWO_SIDED|95.0|-0.37|0.75|||Mixed Models Analysis|||||0.75|-0.37|0.5099
71145584|NCT02006472|141785077|SUPERIORITY||LSM difference|0.24||||0.4061|TWO_SIDED|95.0|-0.33|0.82|||Mixed Models Analysis|||||0.82|-0.33|0.4061
71145585|NCT02006472|141785078|SUPERIORITY||LSM difference|1.16||||0.0003|TWO_SIDED|95.0|0.54|1.78|||Mixed Models Analysis|||||1.78|0.54|0.0003
71145586|NCT02006472|141785079|SUPERIORITY|||||||0.003|||||||Chi-squared|||||||0.003
71145587|NCT02006472|141785080|SUPERIORITY||LSM difference|-0.0341||||0.0346|TWO_SIDED|95.0|-0.0658|-0.0026|||Mixed Models Analysis|||At Week 26||-0.0026|-0.0658|0.0346
71145588|NCT02006472|141785080|SUPERIORITY||LSM difference|-0.0444||||0.0305|TWO_SIDED|95.0|-0.0847|-0.0042|||Mixed Models Analysis|||At Week 52||-0.0042|-0.0847|0.0305
71145589|NCT00656513|141785085|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||An effect size of 0.50 was chosen for sample size calculation. On the basis of a 2-sided t test with alpha= 0.05 and 1 interim analysis, 130 patients were required for 80% statistical power. Adjustment by 10% for loss to follow-up and retrospective ineligibility of recruited study participants yielded a sample size of 144 patients. Actual power given only 96 patients was 68.6%||||0.45
71145590|NCT00656513|141785087|SUPERIORITY|||||||0.11||||||Two-sided test of values at 4 months.|Wilcoxon (Mann-Whitney)|||||||0.11
71145591|NCT00656513|141785087|SUPERIORITY|||||||0.31||||||Two-sided test of values at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.31
71145592|NCT00656513|141785087|SUPERIORITY|||||||0.21||||||Two-sided test of values at 15 months.|Wilcoxon (Mann-Whitney)|||||||0.21
71145593|NCT00656513|141785088|SUPERIORITY|||||||0.35||||||4-month Physical Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.35
71145594|NCT00656513|141785088|SUPERIORITY|||||||0.78||||||4 months Pain/Discomfort score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.78
71145595|NCT00656513|141785088|SUPERIORITY|||||||0.12||||||4 months Personal/Psychological Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.12
70871460|NCT03302234|141228330|OTHER||Difference in LS Means|-0.42||||0.8151|TWO_SIDED|95.0|-3.96|3.12|||cLDA Model|Constrained longitudinal data analysis (cLDA) Model|Based on a cLDA model with PRO scores as response variable, with covariates for treatment by time interaction, and stratification factors (ECOG, geographic region of the enrolling site, \& predominant tumor histology) as covariates.|||3.12|-3.96|0.8151
70871461|NCT02795832|141228331|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|12.441||0.5016|TWO_SIDED|90.0|-21.24|21.34||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Observed case||21.34|-21.24|0.5016
70871462|NCT02795832|141228331|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-3.01|STANDARD_ERROR_OF_MEAN|12.964||0.4082|TWO_SIDED|90.0|-24.39|18.36||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Multiple imputations||18.36|-24.39|0.4082
70871463|NCT02795832|141228331|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-18.27|STANDARD_ERROR_OF_MEAN|13.138||0.0878|TWO_SIDED|90.0|-40.65|4.11||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Last observation carried forward||4.11|-40.65|0.0878
71145596|NCT00656513|141785088|SUPERIORITY|||||||0.28||||||4-month Social Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.28
71145597|NCT00656513|141785088|SUPERIORITY|||||||0.98||||||6-month Physical Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.98
71145598|NCT00656513|141785088|SUPERIORITY|||||||0.28||||||6-month Pain/Discomfort score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.28
71145599|NCT00656513|141785088|SUPERIORITY|||||||0.13||||||6-month Personal/Psychological Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.13
71145600|NCT00656513|141785088|SUPERIORITY|||||||0.58||||||6-month Social Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.58
71145601|NCT00656513|141785088|SUPERIORITY|||||||0.88||||||9-month Physical Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.88
71145602|NCT00656513|141785088|SUPERIORITY|||||||0.09||||||9-month Pain/Discomfort score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.09
71145603|NCT00656513|141785088|SUPERIORITY|||||||0.49||||||9-month Personal/Psychological Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.49
71145604|NCT00656513|141785088|SUPERIORITY|||||||0.45||||||9-month Social Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.45
70953900|NCT01470001|141410321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.44|TWO_SIDED|95.0|-17.5|6.2||p value was adjusted for age.|ANCOVA||we calculated the estimated difference in change between the placebo and treatment groups.|the difference in change between the groups was measured||6.2|-17.5|0.44
71145605|NCT00656513|141785088|SUPERIORITY|||||||0.45||||||15-month Physical Functioning; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.45
71145606|NCT00656513|141785088|SUPERIORITY|||||||0.3||||||15-month Pain/Discomfort; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.30
71145607|NCT00656513|141785088|SUPERIORITY|||||||0.48||||||15-month Personal/Psychological Functioning; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.48
71145608|NCT00656513|141785088|SUPERIORITY|||||||0.68||||||15-month Social Functioning; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.68
71145609|NCT00656513|141785089|SUPERIORITY|||||||0.97||||||4-month score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.97
71145610|NCT00656513|141785089|SUPERIORITY|||||||0.83||||||6-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.83
71145611|NCT00656513|141785089|SUPERIORITY|||||||0.28||||||9-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.28
71145612|NCT00656513|141785089|SUPERIORITY|||||||0.89||||||15-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.89
71145613|NCT00656513|141785090|SUPERIORITY|||||||0.54||||||4-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.54
71145614|NCT00656513|141785090|SUPERIORITY|||||||0.99||||||6-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.99
71145615|NCT00656513|141785090|SUPERIORITY|||||||0.56||||||6-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.56
71145616|NCT00656513|141785090|SUPERIORITY|||||||0.58||||||6-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.58
71145617|NCT00656513|141785091|SUPERIORITY|||||||0.14||||||Two-sided test, significance level 0.05|t-test, 2 sided|||||||0.14
71145618|NCT01436149|141785109|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.96||0.883|TWO_SIDED|95.0|-1.7|2.0|||Mixed- effects Model for Repeat Measures|||||2.0|-1.7|0.883
71145619|NCT01436149|141785110|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.69||0.576|TWO_SIDED|95.0|-1.8|1.0|||Mixed- effects Model for Repeat Measures|||||1.0|-1.8|0.576
71145620|NCT00573508|141785132|SUPERIORITY_OR_OTHER||Least Square Mean Difference|9.4|||<|0.0001||95.0|6.6|12.2|||ANCOVA|||Statistical Analysis applies to 'Change at End of Treatment'.||12.2|6.6|<0.0001
71145621|NCT00573508|141785133|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Statistical Analysis applies to 'Change at Week 4', 'Change at Week 8' and 'Change at Week 12'.||||<.0001
71145622|NCT00573508|141785134|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-Value represents change from Baseline to Week 12.|ANCOVA|||Statistical Analysis applies to 'Change at Week 12'.||||<.0001
71145623|NCT00573508|141785135|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|||||||0.0006
71145624|NCT00573508|141785143|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-16.8|||<|0.0001||95.0|-22.1|-11.6|||ANCOVA|||Statistical Analysis applies to 'Change at EOT'.||-11.6|-22.1|<.0001
71145625|NCT03253796|141785146|SUPERIORITY||Difference in percentage|50.2|||<|0.001|TWO_SIDED|95.0|34.1|63.6|||Miettinen and Nurminen|Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor||||63.6|34.1|<0.001
71145626|NCT03253796|141785146|SUPERIORITY||Difference in percentage|34.4|||<|0.001|TWO_SIDED|95.0|17.0|49.7|||Meittinen and Nurminen|Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor||||49.7|17.0|<0.001
71145627|NCT03253796|141785149|SUPERIORITY||Difference in percentage|9.5|||||TWO_SIDED|95.0|3.3|19.4|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||19.4|3.3|
71145628|NCT03253796|141785149|SUPERIORITY||Difference in percentage|3.2|||||TWO_SIDED|95.0|-2.8|10.9|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||10.9|-2.8|
71145629|NCT03253796|141785151|SUPERIORITY||Difference in percentage|0.0|||||TWO_SIDED|95.0|-5.9|5.8|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||5.8|-5.9|
71145630|NCT03253796|141785151|SUPERIORITY||Difference in percentage|0.0|||||TWO_SIDED|95.0|-5.9|5.8|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||5.8|-5.9|
71145631|NCT03253796|141785153|SUPERIORITY||Difference in percentage|14.7|||||TWO_SIDED|95.0|0.2|29.0|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||29.0|0.2|
71145632|NCT03253796|141785153|SUPERIORITY||Difference in percentage|14.7|||||TWO_SIDED|95.0|0.2|29.1|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||29.1|0.2|
71145633|NCT03253796|141785155|SUPERIORITY||Difference in percentage|24.9|||||TWO_SIDED|95.0|8.5|40.3|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||40.3|8.5|
71145634|NCT03253796|141785155|SUPERIORITY||Difference in percentage|5.9|||||TWO_SIDED|95.0|-9.9|21.3|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||21.3|-9.9|
71145635|NCT03253796|141785157|SUPERIORITY||Difference in percentage|24.4|||||TWO_SIDED|95.0|9.1|39.0|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||39.0|9.1|
71145636|NCT03253796|141785157|SUPERIORITY||Difference in percentage|22.8|||||TWO_SIDED|95.0|7.3|37.7|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||37.7|7.3|
71145637|NCT03253796|141785161|SUPERIORITY||Difference in percentage|32.9|||<|0.001|TWO_SIDED|95.0|19.2|44.5|||Miettinen and Nurminen|Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor||||44.5|19.2|<0.001
70953901|NCT02236988|141410366|OTHER||Ratio of Adjusted Geometric Means|65.3|||||TWO_SIDED|90.0|55.0|77.6|||||Ratio of adjusted geometric means (Apremilast Modified Release 1 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an analysis of variance (ANOVA) was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||77.6|55.0|
70953902|NCT02236988|141410366|OTHER||Ratio of Adjusted Geometric Means|80.4|||||TWO_SIDED|90.0|67.8|95.5|||||Ratio of adjusted geometric means (Apremilast Modified Release 2 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||95.5|67.8|
70953903|NCT02236988|141410366|OTHER||Ratio of Adjusted Geometric Means|84.2|||||TWO_SIDED|90.0|70.9|99.9|||||Ratio of adjusted geometric means (Apremilast Modified Release 3 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||99.9|70.9|
70953904|NCT02236988|141410368|OTHER||Ratio of Adjusted Geometric Means|61.8|||||TWO_SIDED|90.0|51.7|73.9|||||Ratio of adjusted geometric means (Apremilast Modified Release 1 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||73.9|51.7|
70953905|NCT02236988|141410368|OTHER||Ratio of Adjusted Geometric Means|71.2|||||TWO_SIDED|90.0|59.6|85.1|||||Ratio of adjusted geometric means (Apremilast Modified Release 2 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||85.1|59.6|
70953906|NCT02236988|141410368|OTHER||Ratio of Adjusted Geometric Means|73.8|||||TWO_SIDED|90.0|61.7|88.2|||||Ratio of adjusted geometric means (Apremilast Modified Release 3 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||88.2|61.7|
70953907|NCT02236988|141410369|OTHER||Ratio of Adjusted Geometric Means|62.3|||||TWO_SIDED|90.0|52.1|74.4|||||Ratio of adjusted geometric means (Apremilast Modified Release 1 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||74.4|52.1|
70953908|NCT02236988|141410369|OTHER||Ratio of Adjusted Geometric Means|71.3|||||TWO_SIDED|90.0|59.7|85.2|||||Ratio of adjusted geometric means (Apremilast Modified Release 2 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||85.2|59.7|
70953909|NCT02236988|141410369|OTHER||Ratio of Adjusted Geometric Means|74.0|||||TWO_SIDED|90.0|62.0|88.4|||||Ratio of adjusted geometric means (Apremilast Modified Release 3 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||88.4|62.0|
71145638|NCT03253796|141785162|SUPERIORITY||Difference in percentage|15.9||||0.037|TWO_SIDED|95.0|0.9|30.5|||Miettinen and Nurminen|Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor||||30.5|0.9|0.037
71145639|NCT00528112|141785163|SUPERIORITY_OR_OTHER||failure rate|0.009|||||TWO_SIDED|95.0|0.005|0.017||||||Cumulative failure rate (Kaplan-Meier) at 3 years||0.017|0.005|
71145640|NCT00528112|141785163|SUPERIORITY_OR_OTHER||failure rate|0.01||||||95.0|0.005|0.018||||||Cumulative failure rate (Kaplan-Meier) at 3 years||0.018|0.005|
71145641|NCT00528112|141785185|SUPERIORITY_OR_OTHER||failure rate|0.01445|||||TWO_SIDED|95.0|0.00823|0.02531||||||Cumulative failure rate (Kaplan-Meier) at 5 years||0.02531|0.00823|
71145642|NCT02718898|141785190|SUPERIORITY||Odds Ratio (OR)|33.8|||<|0.001|TWO_SIDED|95.0|12.39|92.23|||Regression, Logistic|||||92.23|12.39|<0.001
71145643|NCT02718898|141785191|SUPERIORITY||Odds Ratio (OR)|102.55|||<|0.001|TWO_SIDED|95.0|22.79|461.43|||Regression, Logistic|||||461.43|22.79|<0.001
71145644|NCT02718898|141785192|SUPERIORITY||Odds Ratio (OR)|16.27|||<|0.001|TWO_SIDED|95.0|5.71|46.4|||Regression, Logistic|||||46.40|5.71|<0.001
71145645|NCT02718898|141785193|SUPERIORITY||Odds Ratio (OR)|13.57|||<|0.001|TWO_SIDED|95.0|4.57|40.29|||Regression, Logistic|||||40.29|4.57|<0.001
71145646|NCT02718898|141785194|SUPERIORITY||Odds Ratio (OR)|9.84|||<|0.001|TWO_SIDED|95.0|3.08|31.4|||Regression, Logistic|||||31.40|3.08|<0.001
71145647|NCT02718898|141785195|SUPERIORITY||Mean Difference (Final Values)|-8.4|STANDARD_ERROR_OF_MEAN|0.86|<|0.001|TWO_SIDED|95.0|-10.1|-6.7|||Mixed Models Analysis|||||-6.7|-10.1|<0.001
71145648|NCT02718898|141785196|SUPERIORITY||Mean Difference (Final Values)|-20.0|STANDARD_ERROR_OF_MEAN|2.15|<|0.001|TWO_SIDED|95.0|-24.3|-15.8|||Mixed Models Analysis|||||-15.8|-24.3|<0.001
71145649|NCT02718898|141785197|SUPERIORITY||Odds Ratio (OR)|13.95|||<|0.001|TWO_SIDED|95.0|6.12|31.8|||Regression, Logistic|||||31.80|6.12|<0.001
71145650|NCT02718898|141785198|SUPERIORITY||Mean Difference (Final Values)|4.506|STANDARD_ERROR_OF_MEAN|1.1339|<|0.001|TWO_SIDED|95.0|2.264|6.748|||ANCOVA|||||6.748|2.264|<0.001
71145651|NCT02718898|141785199|SUPERIORITY||Mean Difference (Final Values)|1.797|STANDARD_ERROR_OF_MEAN|1.0367||0.085|TWO_SIDED|95.0|-0.253|3.847|||ANCOVA|||||3.847|-0.253|0.085
71145652|NCT02718898|141785200|SUPERIORITY||Mean Difference (Final Values)|-28.75|STANDARD_ERROR_OF_MEAN|3.015|<|0.001|TWO_SIDED|95.0|-34.72|-22.78|||Mixed Models Analysis|||Total Score||-22.78|-34.72|<0.001
71145653|NCT02718898|141785200|SUPERIORITY||Mean Difference (Final Values)|-3.81|STANDARD_ERROR_OF_MEAN|0.399|<|0.001|TWO_SIDED|95.0|-4.6|-3.02|||Mixed Models Analysis|||Itch||-3.02|-4.60|<0.001
71145654|NCT02718898|141785200|SUPERIORITY||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|0.405|<|0.001|TWO_SIDED|95.0|-4.3|-2.7|||Mixed Models Analysis|||Pain||-2.70|-4.30|<0.001
71145655|NCT02718898|141785200|SUPERIORITY||Mean Difference (Final Values)|-3.85|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-4.66|-3.04|||Mixed Models Analysis|||Discomfort||-3.04|-4.66|<0.001
70953910|NCT02236988|141410370|OTHER||Median Difference|1.0||||0.009|TWO_SIDED|90.0|0.5|2.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 1 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||2.00|0.5|0.0090
71145656|NCT02718898|141785200|SUPERIORITY||Mean Difference (Final Values)|-3.23|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-4.04|-2.42|||Mixed Models Analysis|||Stinging||-2.42|-4.04|<0.001
71145657|NCT02718898|141785200|SUPERIORITY||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.397|<|0.001|TWO_SIDED|95.0|-3.99|-2.41|||Mixed Models Analysis|||Burning||-2.41|-3.99|<0.001
71145658|NCT02718898|141785200|SUPERIORITY||Mean Difference (Final Values)|-3.81|STANDARD_ERROR_OF_MEAN|0.395|<|0.001|TWO_SIDED|95.0|-4.59|-3.03|||Mixed Models Analysis|||Redness||-3.03|-4.59|<0.001
71145659|NCT02718898|141785200|SUPERIORITY||Mean Difference (Final Values)|-3.78|STANDARD_ERROR_OF_MEAN|0.377|<|0.001|TWO_SIDED|95.0|-4.53|-3.03|||Mixed Models Analysis|||Scaling||-3.03|-4.53|<0.001
71145660|NCT02718898|141785200|SUPERIORITY||Mean Difference (Final Values)|-3.55|STANDARD_ERROR_OF_MEAN|0.385|<|0.001|TWO_SIDED|95.0|-4.31|-2.79|||Mixed Models Analysis|||Cracking||-2.79|-4.31|<0.001
71145661|NCT00894803|141785202|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.15||||0.053|TWO_SIDED|95.0|0.01|1.4|||Regression, Logistic|an exact logistic regression was used due to the number of events|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||1.40|0.01|0.053
71145662|NCT00894803|141785203|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74||||0.23|TWO_SIDED|95.0|0.7|4.31|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||4.31|0.70|0.23
71145663|NCT00894803|141785203|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.53|TWO_SIDED|95.0|0.51|3.71|||Regression, Logistic|adjusting for age, baseline NIHSS score and time to IV rt-PA|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||3.71|0.51|0.53
71145664|NCT00894803|141785205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.15||||0.053|TWO_SIDED|95.0|0.01|1.4|||Regression, Logistic|Exact method used due to number of responses|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||1.40|0.01|0.053
71145665|NCT00894803|141785206|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.76||95.0|0.35|8.02|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||8.02|0.35|0.76
71145666|NCT00894803|141785207|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.99999|TWO_SIDED|95.0|0.24|5.92|||Regression, Logistic|Exact method used due to small number of responses|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||5.92|0.24|0.99999
71145667|NCT00894803|141785208|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.99999|TWO_SIDED|95.0|0.24|5.92|||Regression, Logistic|Exact method used due to number of responses|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||5.92|0.24|0.99999
71145668|NCT00894803|141785209|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.78|TWO_SIDED|95.0|0.38|5.76|||Regression, Logistic|Exact methods used due t number of responses|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||5.76|0.38|0.78
71145669|NCT00894803|141785210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.99999|TWO_SIDED|95.0|0.26|4.18|||Regression, Logistic|Exact method used due to number of responses|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||4.18|0.26|0.99999
71145670|NCT00894803|141785211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.35|TWO_SIDED|95.0|0.63|3.67|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||3.67|0.63|0.35
71145671|NCT00894803|141785211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.85|TWO_SIDED|95.0|0.4|3.02|||Regression, Logistic|adjusting for age, baseline NIHSS and time to IV rt-PA|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||3.02|0.40|0.85
71145672|NCT00894803|141785212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.3|TWO_SIDED|95.0|0.65|3.88|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||3.88|0.65|0.30
71145673|NCT00894803|141785212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.73|TWO_SIDED|95.0|0.44|3.24|||Regression, Logistic|adjusting for age, baseline NIHSS and time to IV rt-PA|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||3.24|0.44|0.73
71145674|NCT00894803|141785213|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.31|TWO_SIDED|95.0|0.61|4.99|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||4.99|0.61|0.31
71145675|NCT00894803|141785214|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.55|TWO_SIDED|95.0|0.47|4.07|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||4.07|0.47|0.55
70953911|NCT02236988|141410370|OTHER||Median Difference|1.26||||0.0073|TWO_SIDED|90.0|0.5|3.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 2 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||3.00|0.50|0.0073
70953912|NCT02236988|141410370|OTHER||Median Difference|2.0|||<|0.0001|TWO_SIDED|90.0|1.0|3.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 3 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||3.00|1.00|<0.0001
70953913|NCT02236988|141410376|OTHER||Ratio of Adjusted Geometric Means|90.9|||||TWO_SIDED|90.0|81.8|101.1|||||Ratio of adjusted geometric means (Apremilast Modified Release 4 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||101.1|81.8|
70953914|NCT02236988|141410376|OTHER||Ratio of Adjusted Geometric Means|73.7|||||TWO_SIDED|90.0|66.3|82.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 5 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||82.0|66.3|
70871464|NCT02795832|141228331|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-37.6|STANDARD_ERROR_OF_MEAN|18.748||0.0275|TWO_SIDED|90.0|-69.53|-5.66||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Worst case imputation||-5.66|-69.53|0.0275
70871465|NCT02795832|141228332|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-11.72||||0.1284|TWO_SIDED|90.0|-28.85|5.51||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Day 5||5.51|-28.85|0.1284
70871466|NCT02795832|141228332|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-5.95||||0.2765|TWO_SIDED|90.0|-22.85|10.95||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Day 8||10.95|-22.85|0.2765
70871467|NCT02795832|141228332|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-6.01||||0.2765|TWO_SIDED|90.0|-23.08|11.06||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Day 10||11.06|-23.08|0.2765
70871468|NCT02795832|141228332|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|0.05||||0.5016|TWO_SIDED|90.0|-21.24|21.34|||ANCOVA|||Day 15||21.34|-21.24|0.5016
70871469|NCT02795832|141228333|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Odds Ratio (OR)|1.55||||0.4789|TWO_SIDED|90.0|0.28|10.75||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< placebo LS mean.|ANCOVA|||EASI 50||10.75|0.28|0.4789
70871470|NCT02795832|141228333|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Odds Ratio (OR)|2.0||||0.3|TWO_SIDED|90.0|0.24|999.0||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< placebo LS mean.|ANCOVA|||EASI-75||999|0.24|0.3000
70871471|NCT02795832|141228334|SUPERIORITY||Odds Ratio (OR)|0.45||||0.5|TWO_SIDED|95.0|0.01|19.2||Results for the ZPL-5212372 and placebo groups are estimated adjusted LS means from the fitted model.|Shapiro-Wilkes test|The p-value tests if the residuals are normally distributed.||||19.20|0.01|0.500
70871472|NCT02795832|141228335|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_DEVIATION|1.22||0.5233|TWO_SIDED|90.0|-2.02|2.16|||Shapiro-Wilkes test|||||2.16|-2.02|0.5233
70871473|NCT02795832|141228336|SUPERIORITY||Odds Ratio (OR)|2.43||||0.2455|TWO_SIDED|95.0|0.45|13.26|||t-test, 1 sided|||||13.26|0.45|0.2455
70871474|NCT02795832|141228337|SUPERIORITY||Mean Difference (Net)|-2.66|STANDARD_ERROR_OF_MEAN|4.521||0.2812|TWO_SIDED|90.0|-10.4|5.09||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< placebo LS mean.|Shapiro-Wilkes test|||||5.09|-10.40|0.2812
70953915|NCT02236988|141410376|OTHER||Ratio of Adjusted Geometric Means|80.2|||||TWO_SIDED|90.0|72.2|89.2|||||Ratio of adjusted geometric means (Apremilast Modified Release 6 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||89.2|72.2|
70953916|NCT02236988|141410377|OTHER||Ratio of Adjusted Geometric Means|84.9|||||TWO_SIDED|90.0|77.5|93.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 4 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||93.0|77.5|
70871475|NCT04523220|141228341|OTHER||Cox Proportional Hazard|0.59|||=|0.222|TWO_SIDED|90.0|0.28|1.21||Due to the explorative nature of these analyses, no multiplicity adjustment was done.|Log Rank|||Two-sided log-rank tests and Cox proportional hazards model were used in the analyses.||1.21|0.28|= 0.222
70871476|NCT04523220|141228341|OTHER||Cox Proportional Hazard|0.72|||=|0.427|TWO_SIDED|90.0|0.36|1.42||Due to the explorative nature of these analyses, no multiplicity adjustment was done.|Log Rank|||Two-sided log-rank tests and Cox proportional hazards model were used in the analyses.||1.42|0.36|= 0.427
71145676|NCT00894803|141785215|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.82|TWO_SIDED|95.0|0.46|2.67|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||2.67|0.46|0.82
70871477|NCT04523220|141228342|OTHER||Cox Proportional Hazard|1.27|||=|0.128|TWO_SIDED|90.0|0.98|1.64||Due to the explorative nature of these analyses, no multiplicity adjustment was done.|Log Rank|||Two-sided log-rank tests and Cox proportional hazards model were used in the analyses.||1.64|0.98|= 0.128
70871478|NCT04523220|141228342|OTHER||Cox Proportional Hazard|1.24|||=|0.166|TWO_SIDED|90.0|0.96|1.61||Due to the explorative nature of these analyses, no multiplicity adjustment was done.|Log Rank|||Two-sided log-rank tests and Cox proportional hazards model were used in the analyses.||1.61|0.96|= 0.166
70871479|NCT02010775|141228350|OTHER||Least Squares Mean (LS) Mean Difference|-3.88|||<|0.001|TWO_SIDED|95.0|-5.58|-2.19|||ANOVA|ANOVA model with treatment, and baseline MMPS grade as factors.||||-2.19|-5.58|< 0.001
70871480|NCT02010775|141228350|OTHER||LS Mean Difference|-6.32|||<|0.001|TWO_SIDED|95.0|-8.02|-4.62|||ANOVA|ANOVA model with treatment, and baseline MMPS grade as factors.||||-4.62|-8.02|<0.001
70871481|NCT02010775|141228350|OTHER||LS Mean Difference|-6.89|||<|0.001|TWO_SIDED|95.0|-8.56|-5.22|||ANOVA|ANOVA model with treatment, and baseline MMPS grade as factors.||||-5.22|-8.56|<0.001
70871482|NCT02010775|141228350|OTHER||LS Mean Difference|-7.68|||<|0.001|TWO_SIDED|95.0|-9.35|-6.0|||ANOVA|ANOVA model with treatment, and baseline MMPS grade as factors.||||-6.00|-9.35|<0.001
70871483|NCT02010775|141228351|OTHER||Percentage Difference|31.5||||0.008|TWO_SIDED|95.0|9.8|53.3|||Cochran-Mantel-Haenszel|P-values for between-treatment comparisons were determined using Cochran-Mantel-Haenszel (CMH) tests stratified by baseline MMPS.||||53.3|9.8|0.008
70871484|NCT02010775|141228351|OTHER||Percentage Difference|48.2|||<|0.001|TWO_SIDED|95.0|28.6|67.8|||Cochran-Mantel-Haenszel|P-values for between-treatment comparisons were determined using CMH tests stratified by baseline MMPS.||||67.8|28.6|< 0.001
70871485|NCT02010775|141228351|OTHER||Percentage Difference|54.3|||<|0.001|TWO_SIDED|95.0|36.1|72.6|||Cochran-Mantel-Haenszel|P-values for between-treatment comparisons were determined using CMH tests stratified by baseline MMPS.||||72.6|36.1|< 0.001
70871486|NCT02010775|141228351|OTHER||Percentage Difference|54.3|||<|0.001|TWO_SIDED|95.0|36.1|72.6|||Cochran-Mantel-Haenszel|P-values for between-treatment comparisons were determined using CMH tests stratified by baseline MMPS.||||72.6|36.1|<0.001
70953917|NCT02236988|141410377|OTHER||Ratio of Adjusted Geometric Means|72.0|||||TWO_SIDED|90.0|65.8|78.9|||||Ratio of adjusted geometric means (Apremilast Modified Release 5 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||78.9|65.8|
70871487|NCT00256750|141228353|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|3.7|||||TWO_SIDED|97.3|-1.1|9.0||||||||9.0|-1.1|
70871488|NCT00256750|141228353|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|2.7|||||TWO_SIDED|97.3|-2.5|8.1|||||If the lower bound of the CI (belatacept-CsA) was \> -10%, then the corresponding belatacept regimen was considered non-inferior to CsA.|||8.1|-2.5|
70871489|NCT00256750|141228354|SUPERIORITY_OR_OTHER||Difference in Percent|-23.7|||<|0.0001|TWO_SIDED|97.3|-33.3|-13.7|||Chi-squared, Corrected|A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine||||-13.7|-33.3|<.0001
71145677|NCT00894803|141785216|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.44||||0.07|TWO_SIDED|95.0|0.9|6.64|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||6.64|0.90|0.07
71145678|NCT00894803|141785216|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.98||||0.22|TWO_SIDED|95.0|0.67|5.88|||Regression, Logistic|adjusting for age, baseline NIHSS and time to IV rt-PA|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||5.88|0.67|0.22
70953918|NCT02236988|141410377|OTHER||Ratio of Adjusted Geometric Means|78.0|||||TWO_SIDED|90.0|71.2|85.5|||||Ratio of adjusted geometric means (Apremilast Modified Release 6 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||85.5|71.2|
71145679|NCT03337308|141785244|SUPERIORITY||Difference of Least Squares (LS) means|-38.0|STANDARD_ERROR_OF_MEAN|4.32|<|0.001|TWO_SIDED|95.0|-46.5|-29.6|||ANCOVA||Standard Error of the Difference of Least Squares (LS) Means|||-29.6|-46.5|<0.001
71145680|NCT03337308|141785244|SUPERIORITY||Difference of LS means|-19.0|STANDARD_ERROR_OF_MEAN|3.6|<|0.001|TWO_SIDED|95.0|-26.1|-11.9|||ANCOVA||Standard Error of the Difference of LS Means|||-11.9|-26.1|<0.001
71145681|NCT03337308|141785244|SUPERIORITY||Difference of LS means|-13.1|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-19.7|-6.5|||ANCOVA||Standard Error of the Difference of LS Means|||-6.5|-19.7|<0.001
71145682|NCT03337308|141785245|SUPERIORITY||Location shift|-46.1|STANDARD_ERROR_OF_MEAN|12.22|<|0.001|TWO_SIDED|99.0|-78.75|-15.78||using alpha = 0.01|Wilcoxon rank sum test||Standard Error of the Hodges-Lehmann Median Difference|||-15.78|-78.75|<0.001
71145683|NCT03337308|141785245|SUPERIORITY||Median Difference (Final Values)|-25.6|STANDARD_ERROR_OF_MEAN|8.14||0.002|TWO_SIDED|98.0|-45.0|-7.15||using alpha = 0.02|Wilcoxon rank sum test||Standard Error of the Hodges-Lehmann Median Difference|||-7.15|-45.00|0.002
71145684|NCT03337308|141785245|SUPERIORITY||Median Difference (Final Values)|-2.6|STANDARD_ERROR_OF_MEAN|8.08||0.734|TWO_SIDED|98.0|-21.35|16.25||using alpha = 0.02|Wilcoxon rank sum test||Standard Error of the Hodges-Lehmann Median Difference|||16.25|-21.35|0.734
71145685|NCT03337308|141785246|SUPERIORITY|using alpha = 0.01|Difference in LS mean|-33.7|STANDARD_ERROR_OF_MEAN|3.97|<|0.001|TWO_SIDED|99.0|-43.9|-23.4|||ANCOVA||Standard Error of the Difference of LS Means|||-23.4|-43.9|<0.001
71145686|NCT03337308|141785246|SUPERIORITY||Difference in LS means|-17.8|STANDARD_ERROR_OF_MEAN|3.12|<|0.001|TWO_SIDED|98.0|-25.1|-10.5||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means|||-10.5|-25.1|<0.001
71145687|NCT03337308|141785246|SUPERIORITY||Difference in LS means|-12.1|STANDARD_ERROR_OF_MEAN|3.03|<|0.001|TWO_SIDED|98.0|-19.1|-5.0||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means|||-5.0|-19.1|<0.001
71145688|NCT03337308|141785247|SUPERIORITY||Difference of LS means|-27.1|STANDARD_ERROR_OF_MEAN|3.11|<|0.001|TWO_SIDED|99.0|-35.1|-19.1||using alpha = 0.01|ANCOVA||Standard Error of the Difference of LS Means|||-19.1|-35.1|<0.001
71145689|NCT03337308|141785247|SUPERIORITY||Difference of LS means|-14.2|STANDARD_ERROR_OF_MEAN|2.64|<|0.001|TWO_SIDED|98.0|-20.4|-8.1||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means|||-8.1|-20.4|<0.001
71145690|NCT03337308|141785247|SUPERIORITY||Difference of LS means|-10.4|STANDARD_ERROR_OF_MEAN|2.48|<|0.001|TWO_SIDED|98.0|-16.1|-4.6||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means|||-4.6|-16.1|<0.001
71145691|NCT03337308|141785248|SUPERIORITY||Difference of LS means|-30.1|STANDARD_ERROR_OF_MEAN|3.81|<|0.001|TWO_SIDED|99.0|-39.9|-20.3||using alpha = 0.01|ANCOVA||Standard Error of the Difference of LS Means|||-20.3|-39.9|<0.001
71145692|NCT03337308|141785248|SUPERIORITY||Difference of LS means|-12.8|STANDARD_ERROR_OF_MEAN|3.23|<|0.001|TWO_SIDED|98.0|-20.3|-5.3||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means|||-5.3|-20.3|<0.001
71145693|NCT03337308|141785248|SUPERIORITY||Difference of LS means|-9.3|STANDARD_ERROR_OF_MEAN|3.09||0.003|TWO_SIDED|98.0|-16.5|-2.1||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means|||-2.1|-16.5|0.003
71145694|NCT03094416|141785262|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|-0.783797|STANDARD_ERROR_OF_MEAN|0.158271|<|0.0001|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||<0.0001
71145695|NCT03094416|141785263|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|0.037312|STANDARD_ERROR_OF_MEAN|0.026128||0.1607|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.1607
71145696|NCT03094416|141785264|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|3.397559|STANDARD_ERROR_OF_MEAN|4.174962||0.4204|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.4204
71145697|NCT03094416|141785265|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|0.055199|STANDARD_ERROR_OF_MEAN|0.019171||0.0062|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.0062
71145698|NCT03094416|141785266|OTHER|"A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).~Normal distribution of data was tested with Shapiro Wilks. No data transformation was done."|Mean Difference (Final Values)|0.100127|STANDARD_ERROR_OF_MEAN|0.048171||0.0438|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.0438
70871490|NCT00256750|141228354|SUPERIORITY_OR_OTHER||Difference in Percent|-22.9|||<|0.0001|TWO_SIDED|97.3|-32.6|-12.9|||Chi-squared, Corrected|A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine||||-12.9|-32.6|<.0001
70953919|NCT02236988|141410378|OTHER||Ratio of Adjusted Geometric Means|85.5|||||TWO_SIDED|90.0|78.1|93.6|||||Ratio of adjusted geometric means (Apremilast Modified Release 4 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||93.6|78.1|
71145699|NCT03094416|141785267|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|-0.216479|STANDARD_ERROR_OF_MEAN|0.093366||0.0254|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.0254
71145700|NCT03094416|141785268|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|0.011187|STANDARD_ERROR_OF_MEAN|0.036679||0.7619|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.7619
71145701|NCT03094416|141785269|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|-0.121537|STANDARD_ERROR_OF_MEAN|0.064264||0.0655|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.0655
71145702|NCT03094416|141785270|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|0.031636|STANDARD_ERROR_OF_MEAN|0.053033||0.5542|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.5542
71145703|NCT03094416|141785271|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|0.019322|STANDARD_ERROR_OF_MEAN|0.046827||0.682|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.6820
71145704|NCT03094416|141785272|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|-0.049243|STANDARD_ERROR_OF_MEAN|0.024025||0.0468|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.0468
71145705|NCT03094416|141785273|OTHER|"A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).~Normal distribution of data was tested with Shapiro Wilks. No data transformation was done."|Mean Difference (Final Values)|-0.213171|STANDARD_ERROR_OF_MEAN|0.088103||0.0203|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.0203
71145706|NCT03094416|141785274|OTHER|"A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).~Normal distribution of data was tested with Shapiro Wilks. No data transformation was done."|Mean Difference (Final Values)|-0.030904|STANDARD_ERROR_OF_MEAN|0.038699||0.4291|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.4291
71145707|NCT03094416|141785275|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|0.025502|STANDARD_ERROR_OF_MEAN|0.047802||0.5967|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.5967
71145708|NCT03341299|141785309|SUPERIORITY||Ratio of geometric least square means|0.991||||0.7734|TWO_SIDED|95.0|0.932|1.05|||Mixed Models Analysis|||||1.05|0.932|0.7734
71145709|NCT03341299|141785310|SUPERIORITY||difference in LS means|-14.5||||0.719|TWO_SIDED|95.0|-94.38|65.38|||Mixed Models Analysis|||||65.38|-94.38|0.7190
71145710|NCT04607005|141785318|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.067|TWO_SIDED|95.0|-0.89|0.03||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||0.03|-0.89|0.067
71145711|NCT04607005|141785319|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.043|TWO_SIDED|95.0|-0.92|-0.02||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.02|-0.92|0.043
71145712|NCT04607005|141785320|SUPERIORITY||Mean Difference (Final Values)|-1.43||||0.003|TWO_SIDED|95.0|-2.37|-0.5||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.50|-2.37|0.003
71145713|NCT04607005|141785321|SUPERIORITY||Mean Difference (Final Values)|-1.43||||0.002|TWO_SIDED|95.0|-2.35|-0.51||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.51|-2.35|0.002
71145714|NCT04607005|141785322|SUPERIORITY||Mean Difference (Final Values)|-1.54||||0.003|TWO_SIDED|95.0|-2.52|-0.55||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.55|-2.52|0.003
71145715|NCT04607005|141785323|SUPERIORITY||Mean Difference (Final Values)|-1.54||||0.002|TWO_SIDED|95.0|-2.51|-0.57||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.57|-2.51|0.002
71145716|NCT04607005|141785324|SUPERIORITY||Mean Difference (Final Values)|-1.63||||0.012|TWO_SIDED|95.0|-2.9|-0.37||p-Value was based on a ANCOVA Model.|ANCOVA|||||-0.37|-2.90|0.012
71145717|NCT04607005|141785325|SUPERIORITY||Mean Difference (Final Values)|-1.67||||0.009|TWO_SIDED|95.0|-2.93|-0.42||p-Value was based on a ANCOVA Model.|ANCOVA|||||-0.42|-2.93|0.009
71145718|NCT04607005|141785326|SUPERIORITY||Mean Difference (Final Values)|-1.17||||0.005|TWO_SIDED|95.0|-1.99|-0.35||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.35|-1.99|0.005
71145719|NCT04607005|141785327|SUPERIORITY||Mean Difference (Final Values)|-1.21||||0.004|TWO_SIDED|95.0|-2.02|-0.4||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.40|-2.02|0.004
71145720|NCT04607005|141785328|SUPERIORITY||Mean Difference (Final Values)|-10.63||||0.01|TWO_SIDED|95.0|-18.68|-2.57||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-2.57|-18.68|0.010
71145721|NCT04607005|141785329|SUPERIORITY||Mean Difference (Final Values)|-11.39||||0.004|TWO_SIDED|95.0|-19.19|-3.6||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-3.60|-19.19|0.004
71145722|NCT04607005|141785330|SUPERIORITY||Mean Difference (Final Values)|-0.82||||0.009|TWO_SIDED|95.0|-1.43|-0.21||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.21|-1.43|0.009
71145723|NCT04607005|141785331|SUPERIORITY||Mean Difference (Final Values)|-0.89||||0.004|TWO_SIDED|95.0|-1.49|-0.28||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.28|-1.49|0.004
71145724|NCT04607005|141785332|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.026|TWO_SIDED|95.0|0.26|0.92||p-Value was based on Cox Proportional Hazards Model.|Cox proportional hazards model|||||0.92|0.26|0.026
71145725|NCT04607005|141785333|SUPERIORITY||Hazard Ratio (HR)|0.47||||0.018|TWO_SIDED|95.0|0.25|0.88||p-Value was based on Cox Proportional Hazards Model.|Cox proportional hazards model|||||0.88|0.25|0.018
71145726|NCT03919773|141785336|SUPERIORITY|||||||0.629|||||||Kruskal-Wallis|||Intention-to-treat analysis||||0.629
71145727|NCT03919773|141785337|SUPERIORITY|||||||0.718|||||||Fisher Exact|||comparison of proportion with positive treatment response (as defined) in IVIG group compared to albumin||||0.718
71145728|NCT02977403|141785338|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for AB reaction time measures. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. AB reaction times were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-1.948|||||TWO_SIDED|95.0|-20.79|16.894||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in AB, change scores were computed (post-pre = delta). Positive scores represent an increase in AB from pre- to post- intervention. Negative ∆reaction time scores represent a decrease in AB from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in AB following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||16.894|-20.790|
71145729|NCT02977403|141785338|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.952|||||TWO_SIDED|95.0|-35.28|33.377||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||33.377|-35.280|
71145730|NCT02977403|141785339|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficent|0.047|||||TWO_SIDED|95.0|-0.025|0.119||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.119|-0.025|
71145731|NCT02977403|141785339|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.134|||||TWO_SIDED|95.0|-0.288|0.019||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.019|-0.288|
71145732|NCT02977403|141785340|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass and height, race and ethnicity.|beta coefficent|-0.002|||||TWO_SIDED|95.0|-0.085|0.082||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post-intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.082|-0.085|
71145733|NCT02977403|141785340|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.053|||||TWO_SIDED|95.0|-0.177|0.071||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.071|-0.177|
71145734|NCT02977403|141785341|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.08|||||TWO_SIDED|95.0|-0.022|0.182||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.182|-0.022|
71145735|NCT02977403|141785341|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.018|||||TWO_SIDED|95.0|-0.139|0.103||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.103|-0.139|
71145736|NCT02977403|141785342|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.013|||||TWO_SIDED|95.0|-0.086|0.113||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.113|-0.086|
71145737|NCT02977403|141785342|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.035|||||TWO_SIDED|95.0|-0.179|0.109||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.109|-0.179|
71145738|NCT02977403|141785343|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.083|||||TWO_SIDED|95.0|-0.001|0.167||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.167|-0.001|
71145739|NCT02977403|141785343|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.069|||||TWO_SIDED|95.0|-0.201|0.063||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.063|-0.201|
71145740|NCT02977403|141785344|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity|beta coefficient|0.031|||||TWO_SIDED|95.0|-0.059|0.121||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.121|-0.059|
71145741|NCT02977403|141785344|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.002|||||TWO_SIDED|95.0|-0.157|0.152||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.152|-0.157|
70953920|NCT02236988|141410378|OTHER||Ratio of Adjusted Geometric Means|72.6|||||TWO_SIDED|90.0|66.3|79.5|||||Ratio of adjusted geometric means (Apremilast Modified Release 5 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||79.5|66.3|
70953921|NCT02236988|141410378|OTHER||Ratio of Adjusted Geometric Means|78.9|||||TWO_SIDED|90.0|72.0|86.4|||||Ratio of adjusted geometric means (Apremilast Modified Release 6 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||86.4|72.0|
70953922|NCT02236988|141410379|OTHER||Median Difference|2.0||||0.0002|TWO_SIDED|90.0|1.0|3.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 4 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||3.00|1.00|0.0002
70953923|NCT02236988|141410379|OTHER||Median Difference|1.02||||0.0049|TWO_SIDED|90.0|0.5|2.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 5 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||2.00|0.50|0.0049
70953924|NCT02236988|141410379|OTHER||Median Difference|1.5||||0.001|TWO_SIDED|90.0|1.0|2.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 6 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||2.00|1.00|0.0010
70953925|NCT02236988|141410385|OTHER||Ratio of Adjusted Geometric Means|91.0|||||TWO_SIDED|90.0|80.4|103.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 8 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||103.0|80.4|
70953926|NCT02236988|141410385|OTHER||Ratio of Adjusted Geometric Means|88.4|||||TWO_SIDED|90.0|78.1|100.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 9 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||100.0|78.1|
70953927|NCT02236988|141410386|OTHER||Ratio of Adjusted Geometric Means|80.6|||||TWO_SIDED|90.0|73.8|88.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 8 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||88.0|73.8|
71145742|NCT02977403|141785345|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.042|||||TWO_SIDED|95.0|-0.149|0.065||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.065|-0.149|
71145743|NCT02977403|141785345|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.068|||||TWO_SIDED|95.0|-0.266|0.131||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.131|-0.266|
71145744|NCT02977403|141785346|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.034|||||TWO_SIDED|95.0|-0.122|0.053||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.053|-0.122|
71145745|NCT02977403|141785346|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.07|||||TWO_SIDED|95.0|-0.233|0.092||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.092|-0.233|
70953928|NCT02236988|141410386|OTHER||Ratio of Adjusted Geometric Means|78.5|||||TWO_SIDED|90.0|71.9|85.7|||||Ratio of adjusted geometric means (Apremilast Modified Release 9 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||85.7|71.9|
71145746|NCT02977403|141785347|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.042|||||TWO_SIDED|95.0|-0.041|0.126||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.126|-0.041|
70953929|NCT02236988|141410387|OTHER||Ratio of Adjusted Geometric Means|81.1|||||TWO_SIDED|90.0|74.3|88.6|||||Ratio of adjusted geometric means (Apremilast Modified Release 8 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||88.6|74.3|
70953930|NCT02236988|141410387|OTHER||Ratio of Adjusted Geometric Means|79.0|||||TWO_SIDED|90.0|72.3|86.3|||||Ratio of adjusted geometric means (Apremilast Modified Release 9 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||86.3|72.3|
70953931|NCT02236988|141410388|OTHER||Median Difference|0.98||||0.0374|TWO_SIDED|90.0|0.02|1.5|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 8 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||1.50|0.02|0.0374
71145747|NCT02977403|141785347|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.085|||||TWO_SIDED|95.0|-0.252|0.082||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.082|-0.252|
70953932|NCT02236988|141410388|OTHER||Median Difference|0.51||||0.1907|TWO_SIDED|90.0|0.0|1.5|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 9 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||1.50|0.00|0.1907
71145748|NCT02977403|141785348|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.021|||||TWO_SIDED|95.0|-0.06|0.102||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.102|-0.060|
70953933|NCT02236988|141410394|OTHER||Ratio of Adjusted Geometric Means|109.4|||||TWO_SIDED|90.0|98.6|121.3|||||Ratio of adjusted geometric means (Apremilast Modified Release 11 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||121.3|98.6|
70953934|NCT02236988|141410394|OTHER||Ratio of Adjusted Geometric Means|107.2|||||TWO_SIDED|90.0|96.4|119.2|||||Ratio of adjusted geometric means (Apremilast Modified Release 12 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||119.2|96.4|
70953935|NCT02236988|141410394|OTHER||Ratio of Adjusted Geometric Means|72.7|||||TWO_SIDED|90.0|65.5|80.8|||||Ratio of adjusted geometric means (Apremilast Modified Release 13 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||80.8|65.5|
70953936|NCT02236988|141410394|OTHER||Ratio of Adjusted Geometric Means|103.5|||||TWO_SIDED|90.0|93.1|114.9|||||Ratio of adjusted geometric means (Apremilast Modified Release 14 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||114.9|93.1|
70953937|NCT02236988|141410395|OTHER||Ratio of Adjusted Geometric Means|81.5|||||TWO_SIDED|90.0|75.2|88.3|||||Ratio of adjusted geometric means (Apremilast Modified Release 11 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||88.3|75.2|
70953938|NCT02236988|141410395|OTHER||Ratio of Adjusted Geometric Means|82.4|||||TWO_SIDED|90.0|75.9|89.5|||||Ratio of adjusted geometric means (Apremilast Modified Release 12 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||89.5|75.9|
70953939|NCT02236988|141410395|OTHER||Ratio of Adjusted Geometric Means|68.2|||||TWO_SIDED|90.0|62.9|74.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 13 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||74.0|62.9|
70953940|NCT02236988|141410395|OTHER||Ratio of Adjusted Geometric Means|77.4|||||TWO_SIDED|90.0|71.3|84.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 14 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||84.0|71.3|
71145749|NCT02977403|141785348|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.071|||||TWO_SIDED|95.0|-0.26|0.119||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.119|-0.260|
70871491|NCT00256750|141228355|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens|Difference in Percent|10.0|||||TWO_SIDED|97.3|3.3|17.1|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|||17.1|3.3|
70953941|NCT02236988|141410396|OTHER||Ratio of Adjusted Geometric Means|81.9|||||TWO_SIDED|90.0|75.6|88.6|||||Ratio of adjusted geometric means (Apremilast Modified Release 11 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||88.6|75.6|
70953942|NCT02236988|141410396|OTHER||Ratio of Adjusted Geometric Means|83.0|||||TWO_SIDED|90.0|76.5|90.1|||||Ratio of adjusted geometric means (Apremilast Modified Release 12 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||90.1|76.5|
70953943|NCT02236988|141410396|OTHER||Ratio of Adjusted Geometric Means|68.8|||||TWO_SIDED|90.0|63.4|74.5|||||Ratio of adjusted geometric means (Apremilast Modified Release 13 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||74.5|63.4|
70953944|NCT02236988|141410396|OTHER||Ratio of Adjusted Geometric Means|77.8|||||TWO_SIDED|90.0|71.8|84.4|||||Ratio of adjusted geometric means (Apremilast Modified Release 14 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||84.4|71.8|
71145750|NCT02977403|141785349|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.107|||||TWO_SIDED|95.0|0.03|0.185||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.185|0.030|
71145751|NCT02977403|141785349|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.197|||||TWO_SIDED|95.0|-0.346|-0.047||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||-0.047|-0.346|
71145752|NCT02977403|141785350|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.092|||||TWO_SIDED|95.0|0.01|0.175||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.175|0.010|
71145753|NCT02977403|141785350|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.049|||||TWO_SIDED|95.0|-0.204|0.107||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.107|-0.204|
71145754|NCT02977403|141785351|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.046|||||TWO_SIDED|95.0|-0.032|0.123||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.123|-0.032|
71145755|NCT02977403|141785351|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|0.007|||||TWO_SIDED|95.0|-0.163|0.177||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.177|-0.163|
70953945|NCT02236988|141410397|OTHER||Median Difference|0.98||||0.0523|TWO_SIDED|90.0|0.03|1.5|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 11 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||1.50|0.03|0.0523
70953946|NCT02236988|141410397|OTHER||Median Difference|0.5||||0.2598|TWO_SIDED|90.0|0.0|1.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 12 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||1.00|0.00|0.2598
70953947|NCT02236988|141410397|OTHER||Median Difference|1.5||||0.0053|TWO_SIDED|90.0|1.0|3.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 13 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||3.00|1.00|0.0053
70953948|NCT02236988|141410397|OTHER||Median Difference|0.5||||0.1093|TWO_SIDED|90.0|0.0|1.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 14 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||1.00|0.00|0.1093
70953949|NCT04032613|141410412|OTHER|Paired sample t-test||||||0.2||||||Statistically significant p-value is \<0.05|Paired sample t-test|||||||0.20
70953950|NCT04032613|141410413|OTHER|Paired sample t-test||||||0.05||||||Statistically significant p-value is \<0.05|Paired sample t-test|||||||0.05
70953951|NCT04032613|141410414|OTHER|Paired sample t-test||||||0.004||||||Statistically significant p-value is \<0.05|Paired sample t-test|||||||0.004
70953952|NCT04032613|141410415|OTHER|Paired sample t-test||||||0.14||||||Statistically significant p-value is \<0.05|Paired sample t-test|||||||0.14
70953953|NCT02071290|141410423|SUPERIORITY|||||||0.56|||||||Mixed Models Analysis|||||||0.56
71145756|NCT02977403|141785352|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.041|||||TWO_SIDED|95.0|-0.03|0.112||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.112|-0.03|
71145757|NCT02977403|141785352|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.014|||||TWO_SIDED|95.0|-0.168|0.14||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.140|-0.168|
70953954|NCT02071290|141410424|SUPERIORITY|||||||0.287|||||||Mixed Models Analysis|||||||0.287
70953955|NCT02071290|141410425|SUPERIORITY|||||||0.597|||||||Mixed Models Analysis|||||||0.597
70953956|NCT02071290|141410426|SUPERIORITY|||||||0.307|||||||Mixed Models Analysis|||||||0.307
70953957|NCT02071290|141410427|SUPERIORITY|||||||0.646|||||||Mixed Models Analysis|||||||0.646
70953958|NCT02071290|141410428|SUPERIORITY|||||||0.757|||||||Mixed Models Analysis|||||||0.757
70953959|NCT02071290|141410429|SUPERIORITY|||||||0.075|||||||Mixed Models Analysis|||||||0.075
70953960|NCT02071290|141410430|SUPERIORITY|||||||0.967|||||||Mixed Models Analysis|||||||0.967
70953961|NCT02071290|141410431|SUPERIORITY|||||||0.637|||||||Mixed Models Analysis|||||||0.637
70953962|NCT02071290|141410432|SUPERIORITY|||||||0.664|||||||Mixed Models Analysis|||||||0.664
70953963|NCT02071290|141410433|SUPERIORITY|||||||0.661|||||||Mixed Models Analysis|||||||0.661
70953964|NCT02071290|141410434|SUPERIORITY|||||||0.916|||||||Mixed Models Analysis|||||||0.916
70953965|NCT02071290|141410435|SUPERIORITY|||||||0.437|||||||Mixed Models Analysis|||||||0.437
70953966|NCT02071290|141410436|SUPERIORITY|||||||0.353|||||||Mixed Models Analysis|||||||0.353
70953967|NCT02071290|141410437|SUPERIORITY|||||||0.99|||||||Mixed Models Analysis|||||||0.99
70953968|NCT02071290|141410438|SUPERIORITY|||||||0.085|||||||Mixed Models Analysis|||||||0.085
70953969|NCT02071290|141410439|SUPERIORITY|||||||0.371|||||||Mixed Models Analysis|||||||0.371
70953970|NCT02071290|141410440|SUPERIORITY|||||||0.106|||||||Mixed Models Analysis|||||||0.106
70953971|NCT02071290|141410441|SUPERIORITY|||||||0.829|||||||Mixed Models Analysis|||||||0.829
70953972|NCT02071290|141410442|SUPERIORITY|||||||0.323|||||||Wilcoxon (Mann-Whitney)|||||||0.323
70953973|NCT02071290|141410443|SUPERIORITY|||||||0.287|||||||Wilcoxon (Mann-Whitney)|||||||0.287
71145758|NCT02977403|141785353|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.037|||||TWO_SIDED|95.0|-0.125|0.052||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.052|-0.125|
71145759|NCT02977403|141785353|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.034|||||TWO_SIDED|95.0|-0.196|0.129||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.129|-0.196|
71145760|NCT02977403|141785354|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.001|||||TWO_SIDED|95.0|-0.091|0.093||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.093|-0.091|
71145761|NCT02977403|141785354|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.143|||||TWO_SIDED|95.0|-0.286|0.001||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.001|-0.286|
71145762|NCT02977403|141785355|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.065|||||TWO_SIDED|95.0|-0.001|0.132||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.132|-0.001|
71145763|NCT02977403|141785355|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.095|||||TWO_SIDED|95.0|-0.246|0.055||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.055|-0.246|
71145764|NCT02977403|141785356|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.023|||||TWO_SIDED|95.0|-0.055|0.101||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.101|-0.055|
71145765|NCT02977403|141785356|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.02|||||TWO_SIDED|95.0|-0.178|0.137||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.137|-0.178|
70953974|NCT02071290|141410444|SUPERIORITY|||||||0.151|||||||Wilcoxon (Mann-Whitney)|||||||0.151
70953975|NCT02071290|141410445|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.510
70953976|NCT02071290|141410446|SUPERIORITY|||||||0.348|||||||Chi-squared|||||||0.348
70953977|NCT02071290|141410447|SUPERIORITY|||||||0.911|||||||Chi-squared|||||||0.911
70953978|NCT04488770|141410500|OTHER||Ratio of Geometric Mean|0.75|||||TWO_SIDED|90.0|0.61|0.93|||||Mixed Effect Model has been used to assess Food Effect for the log transformed parameter AUC(0-24). Treatment in the fed/fasted state is fitted as Fixed Effect. Participant is fitted as Random Effect. Unstructured covariance structure is used.|||0.93|0.61|
70953979|NCT04488770|141410501|OTHER||Ratio of Geometric Mean|0.8|||||TWO_SIDED|90.0|0.65|0.98|||||Mixed Effect Model was used to assess Food Effect for the log transformed parameter AUC(0-t). Treatment in the fed/fasted state was fitted as Fixed Effect. Participant was fitted as Random Effect. Unstructured covariance structure was used.|||0.98|0.65|
70953980|NCT04488770|141410502|OTHER||Ratio of Geometric Mean|0.8|||||TWO_SIDED|90.0|0.65|0.98|||||Mixed Effect Model was used to assess Food Effect for log transformed parameter AUC(0-infinity). Treatment in the fed/fasted state was fitted as Fixed Effect. Participant was fitted as Random Effect. Unstructured covariance structure was used.|||0.98|0.65|
71145766|NCT02977403|141785357|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.032|||||TWO_SIDED|95.0|-0.116|0.051||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.051|-0.116|
71145767|NCT02977403|141785357|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|0.06|||||TWO_SIDED|95.0|-0.104|0.223||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.223|-0.104|
70953981|NCT04488770|141410503|OTHER||Ratio of Geometric Mean|0.59|||||TWO_SIDED|90.0|0.46|0.75|||||Mixed Effect Model was used to assess Food Effect for the log transformed parameter Cmax. Treatment in the fed/fasted state was fitted as Fixed Effect. Participant was fitted as Random Effect. Unstructured covariance structure was used.|||0.75|0.46|
70953982|NCT04488770|141410504|OTHER||Ratio of Geometric Mean|0.91|||||TWO_SIDED|90.0|0.74|1.11|||||Mixed Effect Model was used to assess Food Effect for the log transformed parameter C24h. Treatment in the fed/fasted state was fitted as Fixed Effect. Participant was fitted as Random Effect. Unstructured covariance structure was used.|||1.11|0.74|
70953983|NCT04488770|141410505|OTHER||Median Difference (Net)|0.0|||||TWO_SIDED|90.0|0.0|2.0|||||Wilcoxon matched pair test was used to assess Food Effect for the parameter Tmax.|||2.000|0.000|
70953984|NCT04488770|141410506|OTHER||Median Difference (Net)|0.0|||||TWO_SIDED|90.0|0.0|0.25|||||Wilcoxon matched pair test was used to assess Food Effect for the parameter Tlag.|||0.250|0.000|
70953985|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dbase at 50 lux is reported."|Slope|7.11|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
70953986|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dcon at 50 lux is reported."|Slope|5.98|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
70953987|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Ctime at 50 lux is reported."|Slope|7.17||||0.0006|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0006
70953988|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dend at 50 lux is reported."|Slope|4.75|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
71145768|NCT02977403|141785358|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.012|||||TWO_SIDED|95.0|-0.078|0.053||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.053|-0.078|
71145769|NCT02977403|141785358|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.064|||||TWO_SIDED|95.0|-0.248|0.12||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.120|-0.248|
71145770|NCT02977403|141785359|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.089|||||TWO_SIDED|95.0|0.004|0.174||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.174|0.004|
71145771|NCT02977403|141785359|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|0.021|||||TWO_SIDED|95.0|-0.159|0.201||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.201|-0.159|
71145772|NCT02977403|141785360|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.016|||||TWO_SIDED|95.0|-0.113|0.081||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.081|-0.113|
71145773|NCT02977403|141785360|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.072|||||TWO_SIDED|95.0|-0.206|0.062||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.062|-0.206|
71145774|NCT02977403|141785361|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.129|||||TWO_SIDED|95.0|0.049|0.209||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.209|0.049|
71145775|NCT02977403|141785361|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.181|||||TWO_SIDED|95.0|-0.33|-0.033||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||-0.033|-0.330|
70953989|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCA at 50 lux is reported."|Slope|5.95||||0.0002|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0002
70953990|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for D2m at 500 lux is reported."|Slope|6.92||||0.0285|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0285
70953991|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dbase at 500 lux is reported."|Slope|6.99|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
70953992|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dcon at 500 lux is reported."|Slope|6.8|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
70953993|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dend at 500 lux is reported."|Slope|5.94||||0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0001
71145776|NCT02977403|141785362|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.126|||||TWO_SIDED|95.0|0.045|0.207||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.207|0.045|
71145777|NCT02977403|141785362|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.056|||||TWO_SIDED|95.0|-0.223|0.112||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.112|-0.223|
70871492|NCT00256750|141228355|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens. The 20% non-inferiority margin was not met in the belatacept MI group.|Difference in Percent|14.7|||||TWO_SIDED|97.3|7.5|22.2|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|||22.2|7.5|
70871493|NCT00256750|141228356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.0|||<|0.0001|TWO_SIDED|97.3|7.3|18.7||To account for missing measured GFR due to graft loss or death, an ANOVA model on the ranks of measured GFR (with imputed missing values) at Months 12 with factor for randomization group was applied. Measured GFR missing were assigned the worst rank.|Kruskal-Wallis|Tests comparing a belatacept to CsA were based on the Kruskal-Wallis test (using a chi-square approximation of the distribution of the test statistic)|Test were conducted at a level of 0.027 (2-sided).|Time Frame = Day 1 to Month 12||18.7|7.3|<0.0001
70953994|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCA at 500 lux is reported."|Slope|5.85||||0.012|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.012
70953995|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for NYmass at 500 lux is reported."|Slope|-9.62||||0.0174|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0174
70953996|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for D1m at 500 lux is reported."|Slope|-9.15||||0.013|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.013
70953997|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for NCdiff at 50 lux is reported."|Slope|-4.06|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
70953998|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dbase at 50 lux is reported."|Slope|0.99||||0.0068|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0068
70953999|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCV at 50 lux is reported."|Slope|1.12||||0.0485|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0485
70954000|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Ctime at 50 lux is reported."|Slope|2.08||||0.0031|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0031
71145778|NCT02977403|141785363|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.115|||||TWO_SIDED|95.0|0.027|0.203||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.203|0.027|
71145779|NCT02977403|141785363|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.058|||||TWO_SIDED|95.0|-0.203|0.087||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.087|-0.203|
70871494|NCT00256750|141228356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.6|||<|0.0001|TWO_SIDED|97.3|8.9|20.4||To account for missing measured GFR due to graft loss or death, an ANOVA model on the ranks of measured GFR (with imputed missing values) at Months 12 with factor for randomization group was applied. Measured GFR missing were assigned the worst rank.|Kruskal-Wallis|Tests comparing a belatacept to CsA were based on the Kruskal-Wallis test (using a chi-square approximation of the distribution of the test statistic)|Test were conducted at a level of 0.027 (2-sided).|Time Frame = Day 1 to Month 12||20.4|8.9|<0.0001
71145780|NCT02977403|141785364|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.037|||||TWO_SIDED|95.0|-0.053|0.127||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.127|-0.053|
71145781|NCT02977403|141785364|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.085|||||TWO_SIDED|95.0|-0.24|0.069||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.069|-0.240|
71145782|NCT02977403|141785365|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.021|||||TWO_SIDED|95.0|-0.092|0.05||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.050|-0.092|
71145783|NCT02977403|141785365|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.096|||||TWO_SIDED|95.0|-0.249|0.056||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.056|-0.249|
71145784|NCT02977403|141785366|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.013|||||TWO_SIDED|95.0|-0.095|0.069||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.069|-0.095|
71145785|NCT02977403|141785366|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.078|||||TWO_SIDED|95.0|-0.227|0.071||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.071|-0.227|
71145786|NCT02977403|141785367|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.005|||||TWO_SIDED|95.0|-0.103|0.092||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.092|-0.103|
70954001|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCA at 50 lux is reported."|Slope|1.18||||0.0036|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0036
71145787|NCT02977403|141785367|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.032|||||TWO_SIDED|95.0|-0.173|0.11||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.110|-0.173|
71145788|NCT02977403|141785368|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.02|||||TWO_SIDED|95.0|-0.069|0.109||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.109|-0.069|
71145789|NCT02977403|141785368|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.088|||||TWO_SIDED|95.0|-0.252|0.077||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.077|-0.252|
71145790|NCT02977403|141785369|OTHER|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.01|||||TWO_SIDED|95.0|-0.099|0.08||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.080|-0.099|
71145791|NCT02977403|141785369|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.155|||||TWO_SIDED|95.0|-0.294|-0.017||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||-0.017|-0.294|
71145792|NCT02977403|141785370|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.013|||||TWO_SIDED|95.0|-0.069|0.095||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.095|-0.069|
71145793|NCT02977403|141785370|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.085|||||TWO_SIDED|95.0|-0.216|0.047||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.047|-0.216|
70871495|NCT00256750|141228356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.4|||<|0.0001|TWO_SIDED|97.3|11.5|23.4||To account for missing measured GFR due to graft loss or death, an ANOVA model on the ranks of measured GFR (with imputed missing values) at Months 24 with factor for randomization group was applied. Measured GFR missing were assigned the worst rank.|Kruskal-Wallis|Tests comparing a belatacept to CsA were based on the Kruskal-Wallis test (using a chi-square approximation of the distribution of the test statistic)|Test were conducted at a level of 0.027 (2-sided).|Time Frame = Day 1 to Month 24||23.4|11.5|<0.0001
70871496|NCT00256750|141228356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.5|||<|0.0001|TWO_SIDED|97.3|8.5|20.5||To account for missing measured GFR due to graft loss or death, an ANOVA model on the ranks of measured GFR (with imputed missing values) at Months 24 with factor for randomization group was applied. Measured GFR missing were assigned the worst rank.|Kruskal-Wallis|Tests comparing a belatacept to CsA were based on the Kruskal-Wallis test (using a chi-square approximation of the distribution of the test statistic)|Test were conducted at a level of 0.027 (2-sided).|Time Frame = Day 1 to Month 24||20.5|8.5|<0.0001
70871497|NCT00256750|141228357|NON_INFERIORITY_OR_EQUIVALENCE|Test of superiority using DerSimonian-Laird statistic at 0.027 level of significance.|Difference in Percent|-8.5||||0.0581|TWO_SIDED|97.3|-17.9|0.9|||Chi-squared, Corrected|A continuity corrected chi-square test at a significance level of 0.027 was performed.||||0.9|-17.9|0.0581
70871498|NCT00256750|141228357|NON_INFERIORITY_OR_EQUIVALENCE|Test of superiority using DerSimonian-Laird statistic at 0.027 level of significance.|Difference in Percent|-14.2||||0.001|TWO_SIDED|97.3|-23.2|-5.0|||Chi-squared, Corrected|A continuity corrected chi-square test at a significance level of 0.027 was performed.||||-5.0|-23.2|0.0010
70871499|NCT00256750|141228362|SUPERIORITY_OR_OTHER||Difference in Percent|-8.5|||||TWO_SIDED|97.3|-14.6|-3.3|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Percent treatment difference measured as Belatacept - LI minus Cyclosporine||-3.3|-14.6|
70871500|NCT00256750|141228362|SUPERIORITY_OR_OTHER||Difference in Percent|-10.3|||||TWO_SIDED|97.3|-16.1|-5.1|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Percent treatment difference measured as Belatacept - LI minus Cyclosporine||-5.1|-16.1|
70871501|NCT00256750|141228366|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|15.3|||||TWO_SIDED|97.3|10.3|20.3|||||ANOVA model: GFR = treatment|Month 12||20.3|10.3|
70871502|NCT00256750|141228366|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|15.1|||||TWO_SIDED|97.3|10.1|20.1|||||ANOVA model: GFR = treatment|Month 12||20.1|10.1|
70871503|NCT00256750|141228366|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|17.5|||||TWO_SIDED|97.3|12.0|23.1|||||ANOVA model: GFR = treatment|Month 24||23.1|12.0|
70871504|NCT00256750|141228366|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|17.6|||||TWO_SIDED|97.3|12.0|23.3|||||ANOVA model: GFR = treatment|Month 24||23.3|12.0|
70871505|NCT00256750|141228366|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|21.4|||||TWO_SIDED|97.3|15.4|27.4|||||ANOVA model: GFR = treatment|Month 36||27.4|15.4|
70871506|NCT00256750|141228366|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|20.8|||||TWO_SIDED|97.3|14.8|26.9|||||ANOVA model: GFR = treatment|Month 36||26.9|14.8|
70871507|NCT00256750|141228368|SUPERIORITY_OR_OTHER||Difference in Percent|-5.7||||0.0687|TWO_SIDED|97.3|-12.6|0.5||Normal approximation is used if N\>=5 in both arms. Otherwise, exact method is used.|Chi-squared|||Month 12||0.5|-12.6|0.0687
70871508|NCT00256750|141228368|SUPERIORITY_OR_OTHER||Difference in Percent|-2.8||||0.4825|TWO_SIDED|97.3|-10.2|4.4||Normal approximation is used if N\>=5 in both arms. Otherwise, exact method is used.|Chi-squared|||Month 12||4.4|-10.2|0.4825
70871509|NCT00256750|141228368|SUPERIORITY_OR_OTHER||Difference in Percent|-5.1||||0.1267|TWO_SIDED|97.3|-12.3|1.5||Normal approximation is used if N\>=5 in both arms. Otherwise, exact method is used.|Chi-squared|||Month 24||1.5|-12.3|0.1267
70871510|NCT00256750|141228368|SUPERIORITY_OR_OTHER||Difference in Percent|-2.2||||0.6405|TWO_SIDED|97.3|-9.8|5.4||Normal approximation is used if N\>=5 in both arms. Otherwise, exact method is used.|Chi-squared|||Month 24||5.4|-9.8|0.6405
70871511|NCT00256750|141228368|SUPERIORITY_OR_OTHER||Difference in Percent|-4.6||||0.2043|TWO_SIDED|97.3|-12.0|2.5|||Chi-squared|Normal approximation is used if N\>=5 in both arms. Otherwise, exact method is used.||Month 36||2.5|-12.0|0.2043
70871512|NCT00256750|141228368|SUPERIORITY_OR_OTHER||Difference in Percent|-0.9||||0.9481|TWO_SIDED|97.3|-8.8|7.1||Normal approximation is used if N\>=5 in both arms. Otherwise, exact method is used.|Chi-squared|||Month 36||7.1|-8.8|0.9481
70954002|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for RMCA at 50 lux is reported."|Slope|1.05||||0.0089|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0089
70954003|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for NCdiff at 500 lux is reported."|Slope|-4.04|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
71145794|NCT02977403|141785371|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.041|||||TWO_SIDED|95.0|-0.123|0.041||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.041|-0.123|
71145795|NCT02977403|141785371|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.096|||||TWO_SIDED|95.0|-0.213|0.021||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.021|-0.213|
70871513|NCT00256750|141228369|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5||||0.0002|TWO_SIDED|97.3|0.31|0.74|||Chi-squared||Odds ratio is estimated by a cumulative logit model.|||0.74|0.31|0.0002
70871514|NCT00256750|141228369|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.6||||0.0092|TWO_SIDED|97.3|0.38|0.92|||Chi-squared||Odds ratio is estimated by a cumulative logit model.|||0.92|0.38|0.0092
71145796|NCT02977403|141785372|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.038|||||TWO_SIDED|95.0|-0.142|0.066||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.066|-0.142|
70871515|NCT00256750|141228370|SUPERIORITY_OR_OTHER||Difference in Percent|-21.2|||||TWO_SIDED|97.3|-67.6|43.2|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 12||43.2|-67.6|
70871516|NCT00256750|141228370|SUPERIORITY_OR_OTHER||Difference in Percent|-17.9|||||TWO_SIDED|97.3|-72.3|52.2|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 12||52.2|-72.3|
70871517|NCT00256750|141228371|SUPERIORITY_OR_OTHER||Difference in Percent|-1.13|||||TWO_SIDED|97.3|-7.51|5.23|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 12||5.23|-7.51|
70871518|NCT00256750|141228371|SUPERIORITY_OR_OTHER||Difference in Percent|-2.37|||||TWO_SIDED|97.3|-9.01|4.15|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 12||4.15|-9.01|
70871519|NCT00256750|141228372|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-7.3|||||TWO_SIDED|97.3|-11.4|-3.3||||||Systolic, Month 12||-3.3|-11.4|
70954004|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MM30 at 500 lux is reported."|Slope|1.62||||0.0239|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0239
70954005|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dcon at 500 lux is reported."|Slope|0.93||||0.0435|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0435
70954006|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Ctime at 500 lux is reported."|Slope|1.26||||0.0126|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0126
70954007|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for NCdiff at 50 lux is reported."|Slope|-0.73||||0.0294|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0294
70954008|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for D1m at 50 lux is reported."|Slope|0.96||||0.0204|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0204
70954009|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for D2m at 50 lux is reported."|Slope|1.41||||0.0004|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0004
70954010|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCV at 50 lux is reported."|Slope|-0.95||||0.0013|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0013
70871520|NCT00256750|141228372|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-6.0|||||TWO_SIDED|97.3|-10.1|-2.0||||||Systolic, Month 12||-2.0|-10.1|
71145797|NCT02977403|141785372|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.096|||||TWO_SIDED|95.0|-0.29|0.097||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.097|-0.290|
70871521|NCT00256750|141228372|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-3.2|||||TWO_SIDED|97.3|-5.8|-0.7||||||Diastolic, Month 12||-0.7|-5.8|
70871522|NCT00256750|141228372|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-2.6|||||TWO_SIDED|97.3|-5.1|0.0||||||Diastolic, Month 12||0.0|-5.1|
70871523|NCT00256750|141228372|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-4.9|||||TWO_SIDED|97.3|-9.2|-0.6||||||Systolic, Month 24||-0.6|-9.2|
70954011|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCA at 50 lux is reported."|Slope|-0.77||||0.0003|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0003
70871524|NCT00256750|141228372|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-5.5|||||TWO_SIDED|97.3|-9.9|-1.1||||||Systolic, Month 24||-1.1|-9.9|
70871525|NCT00256750|141228372|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-1.9|||||TWO_SIDED|97.3|-4.4|0.5||||||Diastolic, Month 24||0.5|-4.4|
70871526|NCT00256750|141228372|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-2.4|||||TWO_SIDED|97.3|-5.0|0.1||||||Diastolic, Month 24||0.1|-5.0|
70871527|NCT00256750|141228372|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-5.8|||||TWO_SIDED|97.3|-10.0|-1.6||||||Systolic, Month 36||-1.6|-10.0|
70871528|NCT00256750|141228372|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-7.5|||||TWO_SIDED|97.3|-11.7|-3.3||||||Systolic, Month 36||-3.3|-11.7|
70871529|NCT00256750|141228372|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-2.9|||||TWO_SIDED|97.3|-5.4|-0.4||||||Diastolic, Month 36||-0.4|-5.4|
70871530|NCT00256750|141228372|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-3.4|||||TWO_SIDED|97.3|-6.0|-0.9||||||Diastolic, Month 36||-0.9|-6.0|
70871531|NCT00256750|141228373|SUPERIORITY_OR_OTHER||Difference in Percent|7.1|||||TWO_SIDED|97.3|-2.9|17.1|||||A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine|At Month 12||17.1|-2.9|
70871532|NCT00256750|141228373|SUPERIORITY_OR_OTHER||Difference in Percent|3.2|||||TWO_SIDED|97.3|-6.6|12.9|||||A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine|At Month 12||12.9|-6.6|
70954012|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for RMCA at 50 lux is reported."|Slope|-0.94|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
70871533|NCT00256750|141228374|SUPERIORITY_OR_OTHER||Difference in Percent|7.01|||||TWO_SIDED|97.3|-2.79|16.71|||||A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine|||16.71|-2.79|
70871534|NCT00256750|141228374|SUPERIORITY_OR_OTHER||Difference in Percent|3.77|||||TWO_SIDED|97.3|-5.86|13.35|||||A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine|||13.35|-5.86|
70871535|NCT00256750|141228379|SUPERIORITY_OR_OTHER||Difference in Percent|-10.4|||||TWO_SIDED|97.3|-21.4|1.0||||||||1.0|-21.4|
70871536|NCT00256750|141228379|SUPERIORITY_OR_OTHER||Difference in Percent|-8.7|||||TWO_SIDED|97.3|-19.9|2.7||||||||2.7|-19.9|
70871537|NCT00256750|141228381|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens|Difference in Percent|11.4|||||TWO_SIDED|97.3|5.0|18.2|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 6||18.2|5.0|
70871538|NCT00256750|141228381|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens|Difference in Percent|16.5|||||TWO_SIDED|97.3|9.6|23.8|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 6||23.8|9.6|
70871539|NCT00256750|141228381|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens.|Difference in Percent|8.2|||||TWO_SIDED|97.3|1.2|15.4|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used|Month 24||15.4|1.2|
70871540|NCT00256750|141228381|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens.|Difference in Percent|15.2|||||TWO_SIDED|97.3|7.5|23.0|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 24||23.0|7.5|
70871541|NCT00256750|141228381|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens.|Difference in Percent|7.8|||||TWO_SIDED|97.3|0.6|15.0|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 36||15.0|0.6|
70871542|NCT00256750|141228381|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens.|Difference in Percent|14.7|||||TWO_SIDED|97.3|7.0|22.6|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 36||22.6|7.0|
70871543|NCT00256750|141228383|SUPERIORITY_OR_OTHER||Difference in Percent|-3.2|||||TWO_SIDED|95.0|-6.6|-0.6|||||For 95% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|||-0.6|-6.6|
70871544|NCT00256750|141228383|SUPERIORITY_OR_OTHER||Difference in Percent|-3.2|||||TWO_SIDED|95.0|-6.6|-0.6|||||For 95% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|||-0.6|-6.6|
70871545|NCT00256750|141228387|SUPERIORITY_OR_OTHER||Difference in Percent|-0.5|||||TWO_SIDED|97.3|-6.5|5.3||||||Month 12||5.3|-6.5|
71145798|NCT02977403|141785373|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.023|||||TWO_SIDED|95.0|-0.105|0.059||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.059|-0.105|
71145799|NCT02977403|141785373|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.124|||||TWO_SIDED|95.0|-0.277|0.029||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.029|-0.277|
71145800|NCT02977403|141785374|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.057|||||TWO_SIDED|95.0|-0.14|0.027||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.027|-0.140|
71145801|NCT02977403|141785374|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.161|||||TWO_SIDED|95.0|-0.302|-0.02||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||-0.020|-0.302|
71145802|NCT02977403|141785375|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.0002|||||TWO_SIDED|95.0|-0.091|0.091||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.091|-0.091|
71145803|NCT02977403|141785375|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.004|||||TWO_SIDED|95.0|-0.157|0.149||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.149|-0.157|
70871546|NCT00256750|141228387|SUPERIORITY_OR_OTHER||Difference in Percent|-0.9|||||TWO_SIDED|97.3|-6.9|4.8||||||||4.8|-6.9|
70871547|NCT00256750|141228389|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.5||||0.6573|TWO_SIDED|95.0|-1.6|2.6||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 6||2.6|-1.6|0.6573
70871548|NCT00256750|141228389|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.7||||0.1198|TWO_SIDED|95.0|-0.4|3.9||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 6||3.9|-0.4|0.1198
70871549|NCT00256750|141228389|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.0672|TWO_SIDED|95.0|-0.1|3.2||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 6||3.2|-0.1|0.0672
70871550|NCT00256750|141228389|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0257|TWO_SIDED|95.0|0.2|3.6||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 6||3.6|0.2|0.0257
70871551|NCT00256750|141228389|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.8||||0.4146|TWO_SIDED|95.0|-1.2|2.9||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 12||2.9|-1.2|0.4146
70871552|NCT00256750|141228389|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.4||||0.7327|TWO_SIDED|95.0|-1.7|2.4||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 12||2.4|-1.7|0.7327
70871553|NCT00256750|141228389|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.1||||0.0144|TWO_SIDED|95.0|0.4|3.8||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 12||3.8|0.4|0.0144
70871554|NCT00256750|141228389|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.8||||0.0015|TWO_SIDED|95.0|1.1|4.5||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 12||4.5|1.1|0.0015
70871555|NCT00256750|141228389|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.234|TWO_SIDED|95.0|-0.8|3.4||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 24||3.4|-0.8|0.2340
70871556|NCT00256750|141228389|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.5||||0.6635|TWO_SIDED|95.0|-1.7|2.6||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 24||2.6|-1.7|0.6635
70871557|NCT00256750|141228389|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.8||||0.0417|TWO_SIDED|95.0|0.1|3.5||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 24||3.5|0.1|0.0417
70871558|NCT00256750|141228389|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.7||||0.0026|TWO_SIDED|95.0|0.9|4.4||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 24||4.4|0.9|0.0026
70871559|NCT00256750|141228389|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0953|TWO_SIDED|95.0|-0.3|4.1||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 36||4.1|-0.3|0.0953
70871560|NCT00256750|141228389|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.1961|TWO_SIDED|95.0|-0.8|3.7||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 36||3.7|-0.8|0.1961
70871561|NCT00256750|141228389|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.1||||0.0191|TWO_SIDED|95.0|0.3|3.9||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 36||3.9|0.3|0.0191
70871562|NCT00256750|141228389|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.7||||0.0684|TWO_SIDED|95.0|-0.1|3.5||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 36||3.5|-0.1|0.0684
70871563|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0714|TWO_SIDED|95.0|-0.2|3.9|||ANOVA|Domain Score = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 6||3.9|-0.2|0.0714
70871564|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.0||||0.0536|TWO_SIDED|95.0|0.0|4.1|||ANOVA|Domain score = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 6||4.1|-0.0|0.0536
70871565|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.3||||0.7543|TWO_SIDED|95.0|-1.6|2.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 6||2.2|-1.6|0.7543
70871566|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.1||||0.2499|TWO_SIDED|95.0|-0.8|3.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 6||3.0|-0.8|0.2499
70871567|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.2||||0.8332|TWO_SIDED|95.0|-1.9|2.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 6||2.3|-1.9|0.8332
70871568|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.2523|TWO_SIDED|95.0|-0.9|3.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 6||3.4|-0.9|0.2523
70871569|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.9||||0.3018|TWO_SIDED|95.0|-0.8|2.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 6||2.7|-0.8|0.3018
70871570|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.6||||0.5437|TWO_SIDED|95.0|-1.2|2.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 6||2.3|-1.2|0.5437
70871571|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.237|TWO_SIDED|95.0|-0.9|3.6|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 6||3.6|-0.9|0.2370
70871572|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0588|TWO_SIDED|95.0|-0.1|4.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 6||4.5|-0.1|0.0588
71145804|NCT02977403|141785376|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.01|||||TWO_SIDED|95.0|-0.092|0.071||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.071|-0.092|
71145805|NCT02977403|141785376|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|0.029|||||TWO_SIDED|95.0|-0.126|0.183||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.183|-0.126|
70871573|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.0||||0.0502|TWO_SIDED|95.0|0.0|4.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Physical, Month 6||4.0|-0.0|0.0502
70871574|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|3.6||||0.0007|TWO_SIDED|95.0|1.5|5.6|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 6||5.6|1.5|0.0007
70871575|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.3||||0.7637|TWO_SIDED|95.0|-1.8|2.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 6||2.4|-1.8|0.7637
70871576|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.4||||0.7006|TWO_SIDED|95.0|-1.7|2.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 6||2.5|-1.7|0.7006
70871577|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.1222|TWO_SIDED|95.0|-0.4|3.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 6||3.4|-0.4|0.1222
70871578|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0289|TWO_SIDED|95.0|0.2|4.1|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 6||4.1|0.2|0.0289
71145806|NCT02977403|141785377|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.013|||||TWO_SIDED|95.0|-0.101|0.076||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.076|-0.101|
71145807|NCT02977403|141785377|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.106|||||TWO_SIDED|95.0|-0.273|0.06||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.060|-0.273|
71145808|NCT02977403|141785378|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.033|||||TWO_SIDED|95.0|-0.11|0.043||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.043|-0.110|
71145809|NCT02977403|141785378|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.166|||||TWO_SIDED|95.0|-0.335|0.003||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.003|-0.335|
71145810|NCT02977403|141785379|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.011|||||TWO_SIDED|95.0|-0.069|0.091||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.091|-0.069|
71145811|NCT02977403|141785379|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.167|||||TWO_SIDED|95.0|-0.332|-0.002||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||-0.002|-0.332|
70871579|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0571|TWO_SIDED|95.0|-0.1|3.8|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 12||3.8|-0.1|0.0571
70871580|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.9||||0.0042|TWO_SIDED|95.0|0.9|4.9|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 12||4.9|0.9|0.0042
70871581|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0423|TWO_SIDED|95.0|0.1|3.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 12||3.7|0.1|0.0423
70871582|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.3||||0.0174|TWO_SIDED|95.0|0.4|4.1|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 12||4.1|0.4|0.0174
70871583|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.0||||0.363|TWO_SIDED|95.0|-1.1|3.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 12||3.0|-1.1|0.3630
70871584|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.5||||0.6319|TWO_SIDED|95.0|-1.6|2.6|||ANOVA|Missing data were imputed by LOCF|Missing data were imputed by LOCF|Mental Health, Month 12||2.6|-1.6|0.6319
70871585|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.8||||0.0503|TWO_SIDED|95.0|0.0|3.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 12||3.7|-0.0|0.0503
70871586|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.9||||0.3291|TWO_SIDED|95.0|-0.9|2.8|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 12||2.8|-0.9|0.3291
70871587|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.0||||0.386|TWO_SIDED|95.0|-1.2|3.1|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 12||3.1|-1.2|0.3860
70871588|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.0||||0.9672|TWO_SIDED|95.0|-2.2|2.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 12||2.3|-2.2|0.9672
70871589|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.1||||0.0392|TWO_SIDED|95.0|0.1|4.1|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 12||4.1|0.1|0.0392
70871590|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.5||||0.0151|TWO_SIDED|95.0|0.5|4.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 12||4.5|0.5|0.0151
70871591|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.8||||0.3978|TWO_SIDED|95.0|-1.1|2.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 12||2.7|-1.1|0.3978
70871592|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.1263|TWO_SIDED|95.0|-0.4|3.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 12||3.5|-0.4|0.1263
70871593|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.3||||0.016|TWO_SIDED|95.0|0.4|4.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 12||4.2|0.4|0.0160
70871594|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.6||||0.0075|TWO_SIDED|95.0|0.7|4.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 12||4.5|0.7|0.0075
70871595|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.4||||0.699|TWO_SIDED|95.0|-1.6|2.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 24||2.4|-1.6|0.6990
70871596|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.1608|TWO_SIDED|95.0|-0.6|3.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 24||3.5|-0.6|0.1608
70871597|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0214|TWO_SIDED|95.0|0.3|4.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 24||4.0|0.3|0.0214
70871598|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.5||||0.00886|TWO_SIDED|95.0|0.6|4.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 24||4.4|0.6|0.00886
70871599|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.2||||0.2555|TWO_SIDED|95.0|-0.9|3.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 24||3.3|-0.9|0.2555
70871600|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.8||||0.4804|TWO_SIDED|95.0|-1.4|2.9|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 24||2.9|-1.4|0.4804
70871601|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0276|TWO_SIDED|95.0|0.2|4.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 24||4.2|0.2|0.0276
70871602|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.1285|TWO_SIDED|95.0|-0.4|3.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 24||3.5|-0.4|0.1285
70871603|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.7||||0.1352|TWO_SIDED|95.0|-0.5|3.9|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 24||3.9|-0.5|0.1352
70871604|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.2663|TWO_SIDED|95.0|-1.0|3.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 24||3.5|-1.0|0.2663
70871605|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.5||||0.0164|TWO_SIDED|95.0|0.5|4.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 24||4.5|0.5|0.0164
70871606|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|3.9||||0.0002|TWO_SIDED|95.0|1.9|5.9|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 24||5.9|1.9|0.0002
70871607|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.1914|TWO_SIDED|95.0|-0.7|3.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 24||3.3|-0.7|0.1914
70871608|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.4||||0.6882|TWO_SIDED|95.0|-1.6|2.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 24||2.4|-1.6|0.6882
70871609|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.0||||0.0547|TWO_SIDED|95.0|0.0|4.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 24||4.0|-0.0|0.0547
70871610|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.7||||0.0992|TWO_SIDED|95.0|-0.3|3.8|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 24||3.8|-0.3|0.0992
70871611|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.3||||0.0339|TWO_SIDED|95.0|0.2|4.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 36||4.4|0.2|0.0339
70871612|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.0||||0.3572|TWO_SIDED|95.0|-1.1|3.1|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 36||3.1|-1.1|0.3572
70954013|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Redness at 50 lux is reported."|Slope|0.81|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
70871613|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.3||||0.0211|TWO_SIDED|95.0|0.3|4.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 36||4.2|0.3|0.0211
70871614|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.0||||0.045|TWO_SIDED|95.0|0.0|4.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 36||4.0|0.0|0.0450
70871615|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.171|TWO_SIDED|95.0|-0.7|3.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 36||3.7|-0.7|0.1710
70871616|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.2484|TWO_SIDED|95.0|-0.9|3.6|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 36||3.6|-0.9|0.2484
70871617|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.1836|TWO_SIDED|95.0|-0.6|3.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 36||3.2|-0.6|0.1836
70871618|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.0||||0.3303|TWO_SIDED|95.0|-1.0|2.9|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 36||2.9|-1.0|0.3303
70871619|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.5||||0.0299|TWO_SIDED|95.0|0.2|4.8|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 36||4.8|0.2|0.0299
70871620|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.1141|TWO_SIDED|95.0|-0.4|4.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 36||4.2|-0.4|0.1141
70871621|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.7||||0.0087|TWO_SIDED|95.0|0.7|4.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 36||4.7|0.7|0.0087
70871622|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.6||||0.0128|TWO_SIDED|95.0|0.6|4.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 36||4.7|0.6|0.0128
70871623|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.1369|TWO_SIDED|95.0|-0.5|3.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 36||3.5|-0.5|0.1369
70871624|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.5||||0.6331|TWO_SIDED|95.0|-1.5|2.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 36||2.5|-1.5|0.6331
70871625|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0361|TWO_SIDED|95.0|0.1|4.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 36||4.3|0.1|0.0361
70871626|NCT00256750|141228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.1||||0.0525|TWO_SIDED|95.0|0.0|4.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 36||4.2|-0.0|0.0525
70871627|NCT00256750|141228391|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.024|||<|0.0001|TWO_SIDED|95.0|-0.032|-0.015||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 6. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.||-0.015|-0.032|<0.0001
70871628|NCT00256750|141228391|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.019|||<|0.0001|TWO_SIDED|95.0|-0.028|-0.011||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 6. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.||-0.011|-0.028|<0.0001
70871629|NCT00256750|141228391|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.023|||<|0.0001|TWO_SIDED|95.0|-0.031|-0.014||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 6.||-0.014|-0.031|<0.0001
70954014|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for NCdiff at 500 lux is reported."|Slope|-0.87||||0.0096|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0096
70954015|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Redness at 500 lux is reported."|Slope|0.36||||0.0003|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0003
70954016|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MM10 at 50 lux is reported."|Slope|2.13||||0.0063|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0063
70954017|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MM30 at 50 lux is reported."|Slope|2.3||||0.0018|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0018
70954018|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Pa at 50 lux is reported."|Slope|3.22||||0.0134|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0134
70954019|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dbase at 50 lux is reported."|Slope|-1.48|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
70954020|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCV at 50 lux is reported."|Slope|-2.48|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
70954021|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dcon at 50 lux is reported."|Slope|-1.264|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
70954022|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dend at 50 lux is reported."|Slope|-1.47|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
70871630|NCT00256750|141228391|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.026|||<|0.0001|TWO_SIDED|95.0|-0.035|-0.017||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 6.||-0.017|-0.035|<0.0001
70871631|NCT00256750|141228391|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.024|||<|0.0001|TWO_SIDED|95.0|-0.032|-0.016||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 12. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.||-0.016|-0.032|<0.0001
70871632|NCT00256750|141228391|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.02|||<|0.0001|TWO_SIDED|95.0|-0.029|-0.012||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 12. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.||-0.012|-0.029|<0.0001
70871633|NCT00256750|141228391|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.026|||<|0.0001|TWO_SIDED|95.0|-0.034|-0.017||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 12.||-0.017|-0.034|<0.0001
70871634|NCT00256750|141228391|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.025|||<|0.0001|TWO_SIDED|95.0|-0.034|-0.016||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 12.||-0.016|-0.034|<0.0001
70871635|NCT00256750|141228391|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.021|||<|0.0001|TWO_SIDED|95.0|-0.03|-0.013||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 24. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.||-0.013|-0.030|<0.0001
70871636|NCT00256750|141228391|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.015|||<|0.0001|TWO_SIDED|95.0|-0.024|-0.007||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 24. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.||-0.007|-0.024|<0.0001
70871637|NCT00256750|141228391|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.023|||<|0.0001|TWO_SIDED|95.0|-0.031|-0.015||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 24||-0.015|-0.031|<0.0001
70871638|NCT00256750|141228391|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.021|||<|0.0001|TWO_SIDED|95.0|-0.03|-0.013||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 24||-0.013|-0.030|<0.0001
70871639|NCT00256750|141228392|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.8||||0.4498|TWO_SIDED|95.0|-1.2|2.7|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 6||2.7|-1.2|0.4498
70871640|NCT00256750|141228392|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0584|TWO_SIDED|95.0|-0.1|3.9|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 6||3.9|-0.1|0.0584
70871641|NCT00256750|141228392|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.1||||0.1595|TWO_SIDED|95.0|-0.5|2.7|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 6||2.7|-0.5|0.1595
70871642|NCT00256750|141228392|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.7||||0.0457|TWO_SIDED|95.0|0.0|3.3|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 6||3.3|0.0|0.0457
70871643|NCT00256750|141228392|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.1729|TWO_SIDED|95.0|-0.6|3.2|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 12||3.2|-0.6|0.1729
70871644|NCT00256750|141228392|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.8||||0.4209|TWO_SIDED|95.0|-1.1|2.7|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 12||2.7|-1.1|0.4209
70871645|NCT00256750|141228392|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.6||||0.0526|TWO_SIDED|95.0|0.0|3.2|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 12||3.2|-0.0|0.0526
70871646|NCT00256750|141228392|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0077|TWO_SIDED|95.0|0.6|3.9|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 12||3.9|0.6|0.0077
70871647|NCT00256750|141228392|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.4||||0.1849|TWO_SIDED|95.0|-0.6|3.4|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 24||3.4|-0.6|0.1849
70871648|NCT00256750|141228392|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.8||||0.4633|TWO_SIDED|95.0|-1.3|2.8|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 24||2.8|-1.3|0.4633
70871649|NCT00256750|141228392|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.4||||0.0971|TWO_SIDED|95.0|-0.3|3.0|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 24||3.0|-0.3|0.0971
70871650|NCT00256750|141228392|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0102|TWO_SIDED|95.0|0.5|3.8|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 24||3.8|0.5|0.0102
70871651|NCT00256750|141228392|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.5||||0.0186|TWO_SIDED|95.0|0.4|4.5|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 36||4.5|0.4|0.0186
70871652|NCT00256750|141228392|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0775|TWO_SIDED|95.0|-0.2|4.0|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 36||4.0|-0.2|0.0775
70871653|NCT00256750|141228392|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.6||||0.0768|TWO_SIDED|95.0|-0.2|3.3|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 36||3.3|-0.2|0.0768
70871654|NCT00256750|141228392|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.2||||0.1876|TWO_SIDED|95.0|-0.6|2.9|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 36||2.9|-0.6|0.1876
70871655|NCT00256750|141228394|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|4.2|||||TWO_SIDED|97.3|-1.3|10.1||||||Month 24||10.1|-1.3|
70871656|NCT00256750|141228394|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|3.6|||||TWO_SIDED|97.3|-2.2|9.6||||||Month 24||9.6|-2.2|
70871657|NCT00256750|141228394|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|3.3|||||TWO_SIDED|97.3|-2.9|9.8||||||Month 36||9.8|-2.9|
70871658|NCT00256750|141228394|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|3.5|||||TWO_SIDED|97.3|-2.8|10.0||||||||10.0|-2.8|
70871659|NCT00256750|141228395|SUPERIORITY_OR_OTHER||Difference in Percent|5.9|||||TWO_SIDED|95.0|-1.0|12.8||||||Month 12||12.8|-1.0|
70871660|NCT00256750|141228395|SUPERIORITY_OR_OTHER||Difference in Percent|11.5|||||TWO_SIDED|95.0|4.2|18.9||||||Month 12||18.9|4.2|
70871661|NCT00256750|141228395|SUPERIORITY_OR_OTHER||Difference in Percent|1.8|||||TWO_SIDED|95.0|-5.5|9.1||||||Month 24||9.1|-5.5|
70871662|NCT00256750|141228395|SUPERIORITY_OR_OTHER||Difference in Percent|9.8|||||TWO_SIDED|95.0|1.9|17.6||||||Month 24||17.6|1.9|
70871663|NCT00256750|141228395|SUPERIORITY_OR_OTHER||Difference in Percent|0.9|||||TWO_SIDED|95.0|-6.6|8.4||||||Month 36||8.4|-6.6|
70871664|NCT00256750|141228395|SUPERIORITY_OR_OTHER||Difference in Percent|8.4|||||TWO_SIDED|95.0|0.4|16.4||||||Month 36||16.4|0.4|
70871665|NCT01197560|141228403|SUPERIORITY|||||||0.079|||||||Fisher Exact|||Pertains to all participants; row 1||||0.079
70871666|NCT01197560|141228403|SUPERIORITY|||||||0.279|||||||Fisher Exact|||Pertains to GCB Subtype; row 2||||0.279
70871667|NCT01197560|141228403|SUPERIORITY|||||||0.179|||||||Fisher Exact|||Pertains to non-GCB Sub-type; row 3||||0.179
70954023|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCA at 50 lux is reported."|Slope|-1.64|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
70954024|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for RMCA at 50 lux is reported."|Slope|-1.63|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
70954025|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for PESC at 50 lux is reported."|Slope|1.43||||0.0313|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0313
70954026|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MM5 at 500 lux is reported."|Slope|1.92||||0.0481|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0481
70954027|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MM10 at 500 lux is reported."|Slope|2.57||||0.0171|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0171
70954028|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MM30 at 500 lux is reported."|Slope|3.84||||0.0007|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0007
70954029|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for dbase at 500 lux is reported."|Slope|-2.15|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
70871668|NCT01197560|141228404|SUPERIORITY|||||||0.091|||||||Fisher Exact|||Pertains to all participants||||0.091
70871669|NCT01197560|141228405|SUPERIORITY|||||||0.109|||||||Fisher Exact|||||||0.109
70954030|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCV at 500 lux is reported."|Slope|-2.2|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
70954031|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dcon at 500 lux is reported."|Slope|-2.44|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
70954032|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dend at 500 lux is reported."|Slope|-3.01|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
70954033|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCA at 500 lux is reported."|Slope|-1.82|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
70954034|NCT05731999|141410514|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for RMCA at 500 lux is reported."|Slope|-1.83|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
70954035|NCT05731999|141410516|OTHER||probability|0.000244|||<|0.05|TWO_SIDED||||||Regression, Logistic|||The null hypothesis is that the logistic regression classifier is unable to correctly classify subjects into sober or under the influence of D1-D4. The smallest odds ratio from the group false positives and false negative is reported.||||<0.05
70954036|NCT05731999|141410516|OTHER||probability|0.00586|||<|0.05|TWO_SIDED||||||Regression, Logistic|||The null hypothesis is that the logistic regression classifier is unable to correctly classify subjects into sober or under the influence of D1-D4. The greatest p value from the group false positives and false negative is reported.||||<0.05
70954037|NCT05731999|141410516|OTHER||probability|0.0193|||<|0.05|TWO_SIDED||||||Regression, Logistic|||The null hypothesis is that the logistic regression classifier is unable to correctly classify subjects into sober or under the influence of D1-D4. The greatest p value from the group false positives and false negative is reported.||||<0.05
70954038|NCT05731999|141410516|OTHER||probability|0.000488|||<|0.05|TWO_SIDED||||||Regression, Logistic|||The null hypothesis is that the logistic regression classifier is unable to correctly classify subjects into sober or under the influence of D1-D4. The greatest p value from the group false positives and false negative is reported.||||<0.05
70954039|NCT05731999|141410516|OTHER||probability|0.1133|||<|0.05|TWO_SIDED||||||Regression, Logistic|||The null hypothesis is that the logistic regression classifier is unable to correctly classify subjects into sober or under the influence of D1-D4. The greatest p value from the group false positives and false negative is reported.||||<0.05
70954040|NCT05731999|141410516|OTHER||probability|0.0107|||<|0.05|TWO_SIDED||||||Regression, Logistic|||||||<0.05
70954041|NCT03361605|141410542|SUPERIORITY|"Our study adopted a within-subject design, which is not a randomized controlled trial (RCT) such as testing if one treatment is superior to another. Therefore, here the Superiority indicates if propofol administration has a statistically significant impact on the brain activity in response to sensory stimuli."|Mean Difference (Net)|-0.349|STANDARD_DEVIATION|0.223|<|0.0001|TWO_SIDED|||||The threshold for statistical significance was p=0.05. The p-value was not adjusted for multiple comparisons, as only one comparison was performed.|t-test, 2 sided||Difference = BOLD Response During Sedation - BOLD Response During Baseline|The null hypothesis is no difference in BOLD response between sedated state and baseline.||||<0.0001
70954042|NCT03361605|141410543|SUPERIORITY|"Our study adopted a within-subject design, which is not a randomized controlled trial (RCT) such as testing if one treatment is superior to another. Therefore, here the Superiority indicates if propofol administration has a statistically significant impact on the squeeze pressure in response to verbal instructions."|Mean Difference (Net)|-2.16|STANDARD_DEVIATION|3.09||0.00148|TWO_SIDED|||||The threshold for statistical significance was p=0.05. The p-value was not adjusted for multiple comparisons, as only one comparison was performed.|t-test, 2 sided||Difference = Squeeze Pressure During Sedation - Squeeze Pressure During Baseline|The null hypothesis is no difference in squeeze pressure between sedated state and baseline.||||0.00148
70954043|NCT02770612|141410544|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||We used a one sided one sample Wilcoxon test to compare the median number of oxycodone tablets chosen and prescribed to the institutional standard of 40 tablets of oxycodone 5mg on discharge||||<0.001
70954044|NCT02369068|141410545|OTHER|||||||0.072|||||||Kruskal-Wallis|This test was selected since the distribution of the change in pain was not normal nor approximately symmetric.||The null hypothesis assumed there were no differences in the pain score change between groups. Significance level was set at 0.05.||||0.072
70954045|NCT02369068|141410546|OTHER|||||||0.624|||||||Kruskal-Wallis|||The null hypothesis assumed there were no differences in the median change pain severity between the groups. Significance level was set at 0.05||||0.624
70954046|NCT02369068|141410547|OTHER|||||||0.571|||||||Kruskal-Wallis|||The null hypothesis assumed that there is no difference in the change in pain interference between the groups. Statistical significance was set at 0.05||||0.571
70954047|NCT02369068|141410548|OTHER|||||||0.285|||||||Kruskal-Wallis|||The null hypothesis assumed that there was no difference in the distribution between the groups. Significance level was set at 0.05||||0.285
70954048|NCT01989169|141410660|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% CI of the geometric mean ratios were within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|1.215|||||TWO_SIDED|90.0|1.116|1.323|||Mixed-effects Model||The ratio of geometric LS means and 90% CIs for the geometric mean ratio is for Treatment B to Treatment A.|The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in AUCinf, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.||1.323|1.116|
70954049|NCT01989169|141410661|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% CI of the geometric mean ratios fell within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|1.216|||||TWO_SIDED|90.0|1.115|1.327|||Mixed-effects Model||The ratio of geometric LS means and 90% CIs for the geometric mean ratio is for Treatment B to Treatment A.|The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects, and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in AUClast, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.||1.327|1.115|
70954050|NCT01989169|141410662|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% CI of the geometric mean ratios fell within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|1.383|||||TWO_SIDED|90.0|1.282|1.491|||Mixed-effects Model||The ratio of geometric LS means and 90% CIs for the geometric mean ratio is for Treatment B to Treatment A.|The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects, and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in Cmax, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.||1.491|1.282|
70954051|NCT02406677|141410663|SUPERIORITY||Hazard Ratio (HR)|1.073||||0.3503|TWO_SIDED|95.0|0.925|1.246|||Regression, Cox|Cox proportional hazards model accounting for within hospital clustering using robust standard errors|Usual Care arm is the reference group|||1.246|0.925|0.3503
70954052|NCT02406677|141410664|SUPERIORITY||Odds Ratio (OR)|0.838||||0.026|TWO_SIDED|95.0|0.717|0.979|||Regression, Logistic|Logistic regression model with parameters estimated using GEE to account for within hospital clustering for selected patient characteristics||||0.979|0.717|0.0260
70954053|NCT02406677|141410665|SUPERIORITY||Odds Ratio (OR)|2.035|||<|0.0001|TWO_SIDED|95.0|1.564|2.649|||Regression, Logistic|Logistic regression with GEE to account for within hospital clustering||||2.649|1.564|<0.0001
70954054|NCT01114880|141410666|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
70954055|NCT01114880|141410668|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
71145812|NCT02977403|141785380|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.054|||||TWO_SIDED|95.0|-0.037|0.146||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.146|-0.037|
71145813|NCT02977403|141785380|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.019|||||TWO_SIDED|95.0|-0.127|0.09||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.090|-0.127|
70954056|NCT01114880|141410670|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
70954057|NCT01114880|141410672|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
71145814|NCT02977403|141785381|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.002|||||TWO_SIDED|95.0|-0.061|0.065||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.065|-0.061|
70871670|NCT01197560|141228406|SUPERIORITY|||||||0.16|||||||Fisher Exact|||Pertains to all participants; row 1||||0.160
70871671|NCT01197560|141228407|SUPERIORITY|||||||0.529|||||||Log Rank|||||||0.529
70871672|NCT01197560|141228408|SUPERIORITY|||||||0.972|||||||Log Rank|||||||0.972
70871673|NCT01197560|141228409|SUPERIORITY|||||||0.02|||||||Log Rank|||||||0.020
70871674|NCT01197560|141228410|SUPERIORITY|||||||0.211|||||||Log Rank|||||||0.211
70871675|NCT04659161|141228433|SUPERIORITY||LS mean difference|-9.6|||<|0.0001|TWO_SIDED|95.0|-13.9|-5.2|||Mixed Model for Repeated Measures||||Statistics are from a mixed model for repeated measures (MMRM). The model includes the treatment group (KarXT or placebo), visit, and the interaction between the treatment group and visit as fixed factors, and baseline PANSS total score, site, age, and gender as covariates. An unstructured covariance matrix is used to model the correlation among repeated measurements and the denominator degrees of freedom are computed using the Kenward-Roger method.|-5.2|-13.9|<0.0001
71145815|NCT02977403|141785381|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.086|||||TWO_SIDED|95.0|-0.215|0.042||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.042|-0.215|
71145816|NCT02977403|141785382|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.032|||||TWO_SIDED|95.0|-0.05|0.115||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.115|-0.05|
71145817|NCT02977403|141785382|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.095|||||TWO_SIDED|95.0|-0.248|0.058||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.058|-0.248|
70871676|NCT04659161|141228434|SUPERIORITY||||||<|0.0001|||||||Mixed Model for Repeated Measures|||||||<0.0001
70871677|NCT04659161|141228435|SUPERIORITY|||||||0.0055|||||||Mixed Model Repeated Measures|||||||0.0055
70871678|NCT04659161|141228436|SUPERIORITY|||||||0.0022|||||||Mixed Model for Repeated Measures|||||||0.0022
70954058|NCT01114880|141410674|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||< 0.001
70954059|NCT01114880|141410676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared, Corrected|||||||< 0.001
70954060|NCT01114880|141410678|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||< 0.001
70954061|NCT01114880|141410680|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||< 0.001
70954062|NCT01114880|141410682|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
70954063|NCT01114880|141410684|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||< 0.001
70954064|NCT01114880|141410686|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||< 0.001
71145818|NCT02977403|141785383|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.016|||||TWO_SIDED|95.0|-0.075|0.042||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.042|-0.075|
70954065|NCT04143945|141410739|OTHER|Comparison|Estimated treatment difference|2.6||||0.0395|TWO_SIDED|95.0|0.1|5.1|||ANOVA|||The intensity of pain was analysed by a fixed analysis of variance model with VAS pain score as the dependent variable, and product, injection side (right side, left side), injection number (first injection, second injection), and participant as fixed effects.||5.1|0.1|0.0395
70871679|NCT04659161|141228437|SUPERIORITY||||||<|0.0001|||||||Mixed Model for Repeated Measures|||||||<0.0001
70871680|NCT04659161|141228438|SUPERIORITY||||||<|0.0001|||||||Mixed Model for Repeated Measures|||||||<0.0001
70871681|NCT02320669|141228447|SUPERIORITY||Cox Proportional Hazard|1.083|||<|0.05|TWO_SIDED|95.0|0.82|1.432|||Regression, Cox|||||1.432|.82|<.05
70871682|NCT01600638|141228455|OTHER||Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|||||||||||||
70871683|NCT01600638|141228456|OTHER||sucess proportion|0.7823|||||TWO_SIDED|95.0|0.614|0.951||||||||0.951|0.614|
70871684|NCT03338998|141228473|SUPERIORITY||Geo-mean ratio|1.05||||0.585|TWO_SIDED|90.0|0.717|1.535|||ANCOVA|||||1.535|0.717|0.585
70871685|NCT04404361|141228499|SUPERIORITY||Risk Difference (RD)|1.51||||0.8516|TWO_SIDED|95.0|-10.55|13.53|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (\<60 years versus ≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5).||||13.53|-10.55|0.8516
70871686|NCT04404361|141228500|SUPERIORITY|||||||0.7494|||||||Wilcoxon (Mann-Whitney)|||||||0.7494
70871687|NCT04404361|141228501|SUPERIORITY||Odds Ratio (OR)|1.29||||0.6323|TWO_SIDED|95.0|0.46|3.58|||Cochran-Mantel-Haenszel||OR from a CMH test stratified by randomization stratification factors age (\<60 years versus ≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5) as entered in the IXRS|||3.58|0.46|0.6323
70871688|NCT04404361|141228502|SUPERIORITY||Odds Ratio (OR)|1.25||||0.7541|TWO_SIDED|95.0|0.31|4.96|||Cochran-Mantel-Haenszel||OR from a CMH test Stratified by randomization stratification factors age (\<60 years versus ≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5) as entered in the IXRS|||4.96|0.31|0.7541
70871689|NCT04404361|141228503|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.5666|TWO_SIDED|95.0|0.79|1.53||"log-rank test stratified by randomization stratification factors age (\<60 years versus~≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5) as entered in the IXRS"|Log Rank|"stratified by randomization stratification factors age (\<60 years versus~≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5)"|estimated using a stratified Cox proportional hazards model stratified by randomization stratification factors age (\<60 years versus ≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5)|||1.53|0.79|0.5666
70871690|NCT04404361|141228505|SUPERIORITY||Odds Ratio (OR)|2.46||||0.2722|TWO_SIDED|95.0|0.47|12.93|||Chi-squared|||||12.93|0.47|0.2722
70871691|NCT01315678|141228564|SUPERIORITY||Cox Proportional Hazard|1.51||||0.0286|TWO_SIDED|95.0|1.07|2.13|||Regression, Cox|||Stratified Cox proportional hazards model||2.13|1.07|0.0286
70871692|NCT01315678|141228565|SUPERIORITY||Cox Proportional Hazard|1.12||||0.6031|TWO_SIDED|95.0|0.76|1.66|||Regression, Cox|||||1.66|0.76|0.6031
70871693|NCT01315678|141228566|SUPERIORITY||Cox Proportional Hazard|0.84||||0.4861|TWO_SIDED|95.0|0.49|1.44|||Regression, Cox|||||1.44|0.49|0.4861
70871694|NCT05426902|141228573|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Baseline (month 1) vs. intervention period (month 2)||||<0.0001
71145819|NCT02977403|141785383|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|0.025|||||TWO_SIDED|95.0|-0.13|0.18||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.180|-0.130|
70871695|NCT05426902|141228574|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||Baseline (month 1) vs. intervention period (month 2)||||0.6
70871696|NCT05426902|141228575|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||Baseline (month 1) vs. intervention period (month 2)||||0.2
70871697|NCT05426902|141228576|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Baseline (month 1) vs. intervention period (month 2)||||<0.0001
70871698|NCT05426902|141228577|SUPERIORITY|||||||0.4|||||||Fisher Exact|||Baseline (month 1) vs. intervention period (month 2)||||0.4
70871699|NCT05426902|141228582|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||"I feel good about my medical visit at baseline (month 1) vs. intervention period (month 2)."||||0.7
70871700|NCT05426902|141228582|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||"My rheumatologist gave me his/her full attention at baseline (month 1) vs. intervention period (month 2)."||||0.8
70871701|NCT05426902|141228582|SUPERIORITY|||||||1|||||||t-test, 2 sided|||"I was able to say everything I wanted to say to my rheumatologist at baseline (month 1) vs. intervention period (month 2)."||||1.0
70871702|NCT05426902|141228584|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||"My rheumatologist and I agreed on how active my lupus was today at baseline (month 1) vs. intervention period (month 2)."||||0.7
70871703|NCT05426902|141228584|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||"I understand the care recommendations that my doctor or provider gave me today at baseline (month 1) vs. intervention period (month 2)."||||0.8
70871704|NCT05426902|141228585|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Baseline vs. Follow-Up||||0.02
70871705|NCT05426902|141228586|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||"SLE@Duke meets my approval at baseline (month 1) vs. intervention period (month 2)."||||0.7
70871706|NCT05426902|141228586|SUPERIORITY|||||||1|||||||t-test, 2 sided|||"SLE@Duke is appealing to me at baseline (month 1) vs. intervention period (month 2)."||||1.0
70871707|NCT05426902|141228586|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||"I like SLE@Duke at baseline (month 1) vs. intervention period (month 2)."||||0.5
70871708|NCT05426902|141228586|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||"I welcome SLE@Duke at baseline (month 1) vs. intervention period (month 2)."||||0.6
70871709|NCT05426902|141228587|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||"SLE@Duke seems fitting at baseline (month 1) vs. intervention period (month 2)."||||0.7
70871710|NCT05426902|141228587|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||"SLE@Duke seems suitable at baseline (month 1) vs. intervention period (month 2)."||||0.7
70871711|NCT05426902|141228587|SUPERIORITY|||||||1|||||||t-test, 2 sided|||"SLE@Duke seems applicable at baseline (month 1) vs. intervention period (month 2)."||||1.0
70871712|NCT05426902|141228587|SUPERIORITY|||||||1|||||||t-test, 2 sided|||"SLE@Duke seems like a good match at baseline (month 1) vs. intervention period (month 2)."||||1.0
70871713|NCT05426902|141228588|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||"SLE@Duke seems implementable at baseline (month 1) vs. intervention period (month 2)."||||0.3
70871714|NCT05426902|141228588|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||"SLE@Duke seems possible at baseline (month 1) vs. intervention period (month 2)."||||0.3
70871715|NCT05426902|141228588|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||"SLE@Duke seems doable at baseline (month 1) vs. intervention period (month 2)."||||0.4
70954066|NCT00503139|141410758|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sample|A two-sided t-test was performed to test the hypothesis.||The null hypothesis was that mHAQ scores at 6 months, 1 year, 1.5 years, and 2 years were equal to the baseline score.||||<0.001
70954067|NCT00503139|141410759|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sample|A two-sided t-test was performed to test the hypothesis.||The null hypothesis was that VAS Fatigue scores at 6 months, 1 year, 1.5 years, and 2 years were equal to the baseline score.||||<0.001
70871716|NCT05426902|141228588|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||"SLE@Duke seems easy to use at baseline (month 1) vs. intervention period (month 2)."||||0.3
70871717|NCT01751867|141228659|SUPERIORITY_OR_OTHER||ORR %|29.4||||0.003|TWO_SIDED|95.0|15.1|47.5|||Exact binomial proportion test||ORR % = Number of participants who achieved response divided by total ITT participants|Null Hypothesis: threshold for statistical significance = 10%||47.5|15.1|0.003
70871718|NCT01751867|141228659|SUPERIORITY_OR_OTHER||ORR %|25.5|||<|0.001|TWO_SIDED|95.0|17.2|35.3|||Exact binomial proportion test|||Null Hypothesis: threshold for statistical significance = 10%||35.3|17.2|<0.001
70871719|NCT01806545|141228666|SUPERIORITY_OR_OTHER_LEGACY||Proportion treatment difference|-0.11||||0.1197|TWO_SIDED|95.0|-0.242|0.025||P-value was based on Cochran-Mantel-Haenszel test stratified by diabetic status at surgery comparing the 2 treatment groups.|Cochran-Mantel-Haenszel|||||0.025|-0.242|0.1197
70871720|NCT01806545|141228667|SUPERIORITY_OR_OTHER_LEGACY||Proportion treatment difference|-0.08||||0.1962|TWO_SIDED|95.0|-0.204|0.045||P-value was based on Cochran-Mantel-Haenszel test stratified by diabetic status at surgery comparing the 2 treatment groups.|Cochran-Mantel-Haenszel|||||0.045|-0.204|0.1962
70954068|NCT02731690|141410768|SUPERIORITY|||||||0.5303||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.5303
70954069|NCT02731690|141410768|SUPERIORITY|||||||0.1646||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.1646
70871721|NCT01806545|141228668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09|TWO_SIDED|||||P-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||||||0.090
70871722|NCT01806545|141228669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.193|TWO_SIDED||||||Log Rank|P-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.||Analysis of time to loss of patency||||0.193
70871723|NCT01806545|141228670|SUPERIORITY_OR_OTHER_LEGACY|||||||0.231|TWO_SIDED|||||P-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||Analysis of time to loss of patency||||0.231
70871724|NCT01806545|141228671|SUPERIORITY_OR_OTHER_LEGACY|||||||0.158|TWO_SIDED|||||P-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||Analysis of time to loss of patency||||0.158
70871725|NCT01806545|141228672|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|-0.895|||||TWO_SIDED|95.0|-2.213|0.423||||||Treatment difference at week 12||0.423|-2.213|
70954070|NCT02731690|141410768|SUPERIORITY|||||||0.1189||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.1189
70954071|NCT02731690|141410768|SUPERIORITY|||||||0.0706||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.0706
70954072|NCT02731690|141410769|SUPERIORITY|||||||0.0715||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.0715
70954073|NCT02731690|141410769|SUPERIORITY|||||||0.1697||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.1697
70954074|NCT02731690|141410769|SUPERIORITY|||||||0.3428||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.3428
70954075|NCT02731690|141410769|SUPERIORITY|||||||0.0642||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.0642
70954076|NCT02731690|141410770|SUPERIORITY|||||||0.0568||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.0568
70954077|NCT02731690|141410770|SUPERIORITY|||||||0.0533||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.0533
70954078|NCT02731690|141410770|SUPERIORITY|||||||0.0459||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.0459
70871726|NCT01806545|141228672|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|-0.232|||||TWO_SIDED|95.0|-1.791|1.327||||||Treatment difference at week 26||1.327|-1.791|
70954079|NCT02731690|141410770|SUPERIORITY|||||||0.5678||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.5678
70871727|NCT01806545|141228673|SUPERIORITY_OR_OTHER_LEGACY||Proportion treatment difference|-0.04|||||TWO_SIDED|95.0|-0.273|0.2||||||Analysis of week 12||0.200|-0.273|
70871728|NCT01806545|141228673|SUPERIORITY_OR_OTHER_LEGACY||Proportion treatment difference|0.08|||||TWO_SIDED|95.0|-0.165|0.318||||||Analysis of week 26||0.318|-0.165|
70871729|NCT01806545|141228674|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|0.154|||||TWO_SIDED|95.0|-0.096|0.404||||||Analysis of week 12||0.404|-0.096|
70871730|NCT01806545|141228674|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|0.565|||||TWO_SIDED|95.0|-0.023|1.152||||||Analysis of week 26||1.152|-0.023|
70954080|NCT02731690|141410771|SUPERIORITY|||||||0.581||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.5810
70954081|NCT02731690|141410771|SUPERIORITY|||||||0.0465||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.0465
70954082|NCT02731690|141410771|SUPERIORITY|||||||0.1047||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.1047
70954083|NCT02731690|141410771|SUPERIORITY|||||||0.0661||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.0661
70954084|NCT02731690|141410772|SUPERIORITY|||||||0.1615||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.1615
70954085|NCT02731690|141410772|SUPERIORITY|||||||0.6201||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.6201
70954086|NCT02731690|141410772|SUPERIORITY|||||||0.9229||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.9229
70954087|NCT02731690|141410772|SUPERIORITY|||||||0.6307||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.6307
70954088|NCT02731690|141410773|SUPERIORITY|||||||0.0088||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.0088
70954089|NCT02731690|141410773|SUPERIORITY|||||||0.2213||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.2213
70954090|NCT02731690|141410773|SUPERIORITY|||||||0.018||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.0180
70954091|NCT02731690|141410773|SUPERIORITY|||||||0.197||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.1970
70954092|NCT02731690|141410774|SUPERIORITY|||||||0.0752||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.0752
70954093|NCT02731690|141410774|SUPERIORITY|Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.||||||0.6403||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.6403
70954094|NCT02731690|141410774|SUPERIORITY|Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.||||||0.2316||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.2316
70954095|NCT02731690|141410774|SUPERIORITY|||||||0.7635||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.7635
70954096|NCT02731690|141410775|SUPERIORITY|||||||0.0872||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.0872
70954097|NCT02731690|141410775|SUPERIORITY|||||||0.0073||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.0073
70954098|NCT02731690|141410775|SUPERIORITY|||||||0.0086||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.0086
70954099|NCT02731690|141410775|SUPERIORITY|||||||0.0489||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.0489
70954100|NCT00833833|141410778|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.73|||||TWO_SIDED|95.0|0.54|0.99||||||With a 12-month accrual period and 12-month follow-up after the study closed to accrual, assuming a 10% drop out rate, 96 participants in each treatment arm would have had 85% power to detect a hazard rate ratio of 1.67 using a one-sided log rank test with an overall significance level of 0.025 adjusted for one interim analysis) and a significance level of 0.0245 for the final analysis.||0.99|0.54|
70954101|NCT00833833|141410783|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|6.25|||||TWO_SIDED|95.0|0.84|46.66||||||||46.66|0.84|
70954102|NCT00833833|141410784|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.070
70954103|NCT00833833|141410785|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.85|||||TWO_SIDED|95.0|0.57|1.29||||||||1.29|0.57|
70954104|NCT01262677|141410819|SUPERIORITY||Mean Difference|-0.99||||0.9076|TWO_SIDED|95.0|-16.28|17.11||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). 88 participants in each group (264 total) should have provided approximately 90% power.||17.11|-16.28|0.9076
70954105|NCT01262677|141410819|SUPERIORITY||Mean Difference|-13.05||||0.0907|TWO_SIDED|95.0|-26.07|2.25||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). 88 participants in each group (264 total) should have provided approximately 90% power.||2.25|-26.07|0.0907
70954106|NCT01262677|141410820|SUPERIORITY|||||||0.752||||||Statistical testing was done at alpha = 0.05 level, two-sided.|Cochran-Mantel-Haenszel|||A 2-sided Cochran-Mantel-Haenszel test stratified by geographical region (U.S., Europe, Asia, or Rest of the World) was used to calculate the p-value. No adjustments for multiplicity were taken.||||0.752
70954107|NCT01262677|141410820|SUPERIORITY|||||||0.125||||||Statistical testing was done at alpha = 0.05 level, two-sided.|Cochran-Mantel-Haenszel|||A 2-sided Cochran-Mantel-Haenszel test stratified by geographical region (U.S., Europe, Asia, or Rest of the World) was used to calculate the p-value. No adjustments for multiplicity were taken.||||0.125
70954108|NCT01262677|141410821|SUPERIORITY||LS Mean Difference|-9.3||||0.5404|TWO_SIDED|95.0|-39.16|20.56||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model was used to calculate the p-value.||20.56|-39.16|0.5404
70954109|NCT01262677|141410821|SUPERIORITY||LS Mean Difference|-25.84||||0.0786|TWO_SIDED|95.0|-54.64|2.97||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model was used to calculate the p-value.||2.97|-54.64|0.0786
70954110|NCT01262677|141410822|SUPERIORITY||LS Mean Difference|-0.11||||0.6073|TWO_SIDED|95.0|-0.53|0.31||Statistical testing was done at alpha = 0.05 level, two-sided.|Generalized linear model (GLM)|||A generalized linear model accounting for treatment and geographical region as fixed effects and baseline seizure frequency as a covariate was used to calculate the p-value. This generalized linear model assumed that the SGTC seizure frequency was from a Poisson distribution with a canonical log link function.||0.31|-0.53|0.6073
70954111|NCT01262677|141410822|SUPERIORITY||LS Mean Difference|-0.16||||0.4109|TWO_SIDED|95.0|-0.53|0.22||Statistical testing was done at alpha = 0.05 level, two-sided.|GLM|||A generalized linear model accounting for treatment and geographical region as fixed effects and baseline seizure frequency as a covariate was used to calculate the p-value. This generalized linear model assumed that the SGTC seizure frequency was from a Poisson distribution with a canonical log link function.||0.22|-0.53|0.4109
70954112|NCT01262677|141410823|SUPERIORITY||LS Mean Difference|-1.38||||0.8268|TWO_SIDED|95.0|-12.97|11.75||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||11.75|-12.97|0.8268
70954113|NCT01262677|141410823|SUPERIORITY||LS Mean Difference|0.75||||0.9024|TWO_SIDED|95.0|-10.69|13.66||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||13.66|-10.69|0.9024
70954114|NCT01262677|141410824|SUPERIORITY|||||||0.67||||||Statistical testing was done at alpha = 0.05 level, two-sided.|Cochran-Mantel-Haenszel|||A 2-sided Cochran-Mantel-Haenszel test stratified by geographical region (U.S., Europe, Asia, or Rest of the World) wtih percentage of responders summarized by treatment group was used to calculate the p-value.||||0.670
70954115|NCT01262677|141410824|SUPERIORITY|||||||0.927||||||Statistical testing was done at alpha = 0.05 level, two-sided.|Cochran-Mantel-Haenszel|||A 2-sided Cochran-Mantel-Haenszel test stratified by geographical region (U.S., Europe, Asia, or Rest of the World) wtih percentage of responders summarized by treatment group was used to calculate the p-value.||||0.927
70954116|NCT01262677|141410825|SUPERIORITY||LS Mean Difference|2.28||||0.8034|TWO_SIDED|95.0|-14.37|22.15||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||22.15|-14.37|0.8034
70954117|NCT01262677|141410825|SUPERIORITY||LS Mean Difference|-10.78||||0.1905|TWO_SIDED|95.0|-24.81|5.87||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||5.87|-24.81|0.1905
70954118|NCT01262677|141410826|SUPERIORITY||LS Mean Difference|-0.3||||0.465|TWO_SIDED|95.0|-1.1|0.5||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: HADS-A baseline score as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). No adjustments for multiplicity were taken.||0.5|-1.1|0.4650
70954119|NCT01262677|141410826|SUPERIORITY||LS Mean Difference|0.0||||0.9692|TWO_SIDED|95.0|-0.8|0.8||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: HADS-A baseline score as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). No adjustments for multiplicity were taken.||0.8|-0.8|0.9692
70954120|NCT01262677|141410827|SUPERIORITY||LS Mean Difference|-0.5||||0.2693|TWO_SIDED|95.0|-1.3|0.4||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: HADS-D baseline score as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). No adjustments for multiplicity were taken.||0.4|-1.3|0.2693
70954121|NCT01262677|141410827|SUPERIORITY||LS Mean Difference|-0.5||||0.1893|TWO_SIDED|95.0|-1.4|0.3||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: HADS-D baseline score as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). No adjustments for multiplicity were taken.||0.3|-1.4|0.1893
70954122|NCT01262677|141410828|SUPERIORITY||LS Mean Difference|-0.8||||0.7347|TWO_SIDED|95.0|-5.2|3.6||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep disturbance score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||3.6|-5.2|0.7347
70871731|NCT02548650|141228732|NON_INFERIORITY|Under the null hypothesis that the mean aggregation between dual and triple therapy is not equal to 0 and a common standard deviation of 13%, a sample size of 28 patients per group with a valid primary end point time point allowed for the 95% confidence interval (CI) to stay within ± 10% with a 80% power and a two-sided alpha=0.05.|Mean Difference (Net)|12.0|||>|0.05|TWO_SIDED|95.0|3.0|21.0|||ANOVA|||The primary end point of our study was the comparison of CAT-induced MPA measured by LTA between triple (vorapaxar plus DAPT) and dual (vorapaxar plus clopidogrel) therapy. We hypothesized that dual therapy would be non-inferior to triple therapy after 30±5 days of treatment||21|3|>0.05
70871732|NCT01539538|141228734|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of - 15% for lower boundary of 95% confidence interval|difference in proportion|12.9|||<|0.001|TWO_SIDED|95.0|3.69|22.11|||one-sided, z-test|||||22.11|3.69|<0.001
70871733|NCT01539538|141228734|SUPERIORITY_OR_OTHER||Difference in proportion|12.9||||0.007|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.007
70871734|NCT01362205|141228793|OTHER|||||||0.2454|||||||Wilcoxon (Mann-Whitney)|||||||0.2454
70871735|NCT01372462|141228804|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|Newman-Keuls multiple comparisons test||The primary endpoint was difference in endurance between nasal cannula oxygen and NIOV+O2. Assuming 153 sec clinically important difference, 183 sec SD, and α=0.05, a sample size of 15 yielded 85% power.||||<0.05
70871736|NCT01372462|141228804|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70871737|NCT01372462|141228804|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70871738|NCT01372462|141228805|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|Newman-Keuls multiple comparisons test||One-way, repeated-measures ANOVA and Newman-Keuls multiple comparisons test||||< 0.05
70871739|NCT01372462|141228805|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70871740|NCT01372462|141228805|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70871741|NCT01372462|141228806|SUPERIORITY_OR_OTHER||||||<|0.05||||||One-way, repeated-measures ANOVA and Newman-Keuls multiple comparisons tests|ANOVA|Newman-Keuls multiple comparisons tests||Per protocol||||<0.05
70871742|NCT01372462|141228806|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70871743|NCT01372462|141228806|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70871744|NCT01269463|141228810|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||ANCOVA|||||||<0.01
70871745|NCT01269463|141228811|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||ANCOVA|||||||<0.01
70871746|NCT01125605|141228823|SUPERIORITY_OR_OTHER|||||||0.0033||95.0|||||ANCOVA|ANCOVA with GLM (Generalized Linear Model) of SAS® (with type III sums of squares); including the baseline value of the sum score as a covariate||decrease of the sum score between baseline (visit 1) and last observation was exploratively analysed||||0.0033
70954123|NCT01262677|141410828|SUPERIORITY||LS Mean Difference|0.3||||0.8971|TWO_SIDED|95.0|-4.0|4.6||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep disturbance score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||4.6|-4.0|0.8971
70871747|NCT01125605|141228823|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANCOVA|ANCOVA with GLM (Generalized Linear Model) of SAS® (with type III sums of squares); including the baseline value of the sum score as a covariate||decrease of the sum score between baseline (visit1) and last observation by duration of treatment||||0.0002
70871748|NCT01125605|141228824|SUPERIORITY_OR_OTHER|||||||0.0014||95.0|||||Fisher Exact|||||||0.0014
70871749|NCT01125605|141228825|SUPERIORITY_OR_OTHER|||||||0.0125||95.0|||||Fisher Exact|||||||0.0125
70871750|NCT01125605|141228826|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||Fisher Exact|||||||0.0006
70871751|NCT01125605|141228827|SUPERIORITY_OR_OTHER|||||||0.0016||95.0|||||Fisher Exact|||||||0.0016
70871752|NCT01125605|141228828|SUPERIORITY_OR_OTHER|||||||0.0504||95.0|||||Fisher Exact|||||||0.0504
70871753|NCT01125605|141228830|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Fisher Exact|||||||0.0002
70871754|NCT05425745|141228873|SUPERIORITY||Least Squares (LS) Means|-36.31|STANDARD_ERROR_OF_MEAN|3.019|<|0.0001|TWO_SIDED|95.0|-42.22|-30.39|||ANCOVA|||||-30.39|-42.22|<.0001
70871755|NCT05425745|141228874|SUPERIORITY||Least Squares (LS) Means|-37.78|STANDARD_ERROR_OF_MEAN|3.572|<|0.0001|TWO_SIDED|95.0|-44.79|-30.78|||ANCOVA|||||-30.78|-44.79|<.0001
70871756|NCT05425745|141228875|SUPERIORITY||Least Squares (LS) Means|-41.45|STANDARD_ERROR_OF_MEAN|4.938|<|0.0001|TWO_SIDED|95.0|-51.14|-31.76||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-31.76|-51.14|<.0001
70871757|NCT05425745|141228876|SUPERIORITY||Least Squares (LS) Means|-24.39|STANDARD_ERROR_OF_MEAN|2.136|<|0.0001|TWO_SIDED|95.0|-28.58|-20.2||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-20.20|-28.58|<.0001
70871758|NCT05425745|141228877|SUPERIORITY||Least Squares (LS) Means|-24.32|STANDARD_ERROR_OF_MEAN|2.583|<|0.0001|TWO_SIDED|95.0|-29.38|-19.25||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-19.25|-29.38|<.0001
70871759|NCT05425745|141228878|SUPERIORITY||Least Squares (LS) Means|-25.77|STANDARD_ERROR_OF_MEAN|3.114|<|0.0001|TWO_SIDED|95.0|-31.88|-19.67||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-19.67|-31.88|<.0001
70871760|NCT05425745|141228879|SUPERIORITY||Least Squares (LS) Means|-34.45|STANDARD_ERROR_OF_MEAN|2.661|<|0.0001|TWO_SIDED|95.0|-39.67|-29.24||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-29.24|-39.67|<.0001
70871761|NCT05425745|141228880|SUPERIORITY||Least Squares (LS) Means|-33.0|STANDARD_ERROR_OF_MEAN|3.241|<|0.0001|TWO_SIDED|95.0|-39.36|-26.65||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-26.65|-39.36|<.0001
70871762|NCT05425745|141228881|SUPERIORITY||Least Squares (LS) Means|-37.48|STANDARD_ERROR_OF_MEAN|4.535|<|0.0001|TWO_SIDED|95.0|-46.38|-28.58||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value \<0.05|ANCOVA|||||-28.58|-46.38|<.0001
70871763|NCT05425745|141228882|SUPERIORITY||Least Squares (LS) Means|138.66|STANDARD_ERROR_OF_MEAN|6.244|<|0.0001|TWO_SIDED|95.0|126.42|150.9||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value \<0.05|ANCOVA|||||150.90|126.42|<.0001
70871764|NCT05425745|141228883|SUPERIORITY||Least Squares (LS) Means|131.2|STANDARD_ERROR_OF_MEAN|6.595|<|0.0001|TWO_SIDED|95.0|118.27|144.13||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value \<0.05|ANCOVA|||||144.13|118.27|<.0001
70871765|NCT05425745|141228884|SUPERIORITY||Least Squares (LS) Means|121.39|STANDARD_ERROR_OF_MEAN|7.333|<|0.0001|TWO_SIDED|95.0|107.02|135.76||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value \<0.05|ANCOVA|||||135.76|107.02|<.0001
70871766|NCT05425745|141228885|SUPERIORITY||Least Squares (LS) Means|-45.94|STANDARD_ERROR_OF_MEAN|10.14|<|0.0001|TWO_SIDED|95.0|-65.88|-26.0||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-26.00|-65.88|<.0001
70871767|NCT05425745|141228886|SUPERIORITY||Least Squares (LS) Means|-54.3|STANDARD_ERROR_OF_MEAN|38.924||0.1648|TWO_SIDED|95.0|-131.13|22.53||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05; therefore hierarchical testing was stopped for subsequent secondary endpoints|ANCOVA|||||22.53|-131.13|0.1648
70871768|NCT02342327|141228893|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.55|1.22||||||Hazard ratio for time to lapse to smoking in the group switched to non-menthol cigarettes relative to the group continuing to smoke menthol cigarettes||1.22|0.55|
70871769|NCT02342327|141228894|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.42|1.06||||||Hazard ratio for time to relapse to smoking in the group switched to non-menthol cigarettes relative to the group continuing to smoke menthol cigarettes||1.06|0.42|
70871770|NCT02674529|141228915|OTHER|This was a mechanistic trial and non-inferiority or equivalence analysis were not performed.|regression coefficient|-1.29864|STANDARD_ERROR_OF_MEAN|2.3||0.58|TWO_SIDED|95.0|||||Regression, Linear|Drug (antidepressant vs. placebo) prediction of changes in mood as measured by the MADRS scores.||||||0.58
70871771|NCT02674529|141228915|OTHER||r|0.02||||0.05|TWO_SIDED||||||Correlation|Change in MADRS after 8 weeks correlation with brain responses during the baseline fMRI task.||||||0.05
70871772|NCT02674529|141228916|OTHER|This is a mechanistic trial, we did not perform non-inferiority or equivalence analysis.|regression coefficient|-1.4328918|STANDARD_DEVIATION|1.4||0.8|TWO_SIDED|95.0|||||Regression, Linear|||||||0.8
70871773|NCT02674529|141228917|OTHER||||||<|0.05||||||The resulting voxel-wise parametric maps are thresholded with height and extent values generated by Monte Carlo simulations with 3dClustSim to protect against overall type I error at p \< 0.05.|t-test, 2 sided|||At the group-level, a random-effects analysis determines the main effects of the regressors of interest (e.g., high vs. low expectancy) resulting in statistical parametric maps (t or F statistics). To control for potential confounders, sex and depression severity will be entered as covariates in statistical models.||||<0.05
70871774|NCT02891850|141228918|EQUIVALENCE|The hypothesis was that there was no difference in the satisfactory clinical response rates in terms of odds ratio (OR) when treated with riociguat compared with participants who remained on their previous therapy.|Odds Ratio (OR)|2.78||||0.0007|TWO_SIDED|95.0|1.526|5.06|||Mantel Haenszel|Stratified by PAH category at baseline||||5.060|1.526|0.0007
70871775|NCT02891850|141228919|EQUIVALENCE|The hypothesis was that there was no difference in the change of 6MWD in terms of mean difference when treated with riociguat compared with participants who remained on their previous therapy.|Mean Difference (Final Values)|22.56||||0.0542|TWO_SIDED|95.0|5.03|40.1|||t-test, 2 sided|Stratified by PAH category at baseline||||40.10|5.03|0.0542
70871776|NCT02891850|141228920|EQUIVALENCE|The hypothesis was that there was no difference in the change of NT-proBNP in terms of mean difference when treated with riociguat compared with participants who remained on their previous therapy.|Mean Difference (Final Values)|-169.65||||0.1067|TWO_SIDED|95.0|-426.18|86.88|||t-test, 2 sided|Stratified by PAH category at baseline||||86.88|-426.18|0.1067
70871777|NCT02891850|141228921|EQUIVALENCE|The hypothesis was that there was no difference in the change from baseline in WHO FC in terms of mean difference when treated with riociguat compared with participants who remained on their previous therapy.|Mean Difference (Final Values)|-0.26||||0.0007|TWO_SIDED|95.0|-0.42|-0.11|||t-test, 2 sided|Stratified by PAH category at baseline||||-0.11|-0.42|0.0007
70871778|NCT02891850|141228922|EQUIVALENCE|The hypothesis was that there was no difference in the clinical worsening rates in terms of odds ratio (OR) when treated with riociguat compared with participants who remained on their previous therapy.|Odds Ratio (OR)|0.1||||0.0047|TWO_SIDED|95.0|0.013|0.725|||Mantel Haenszel|Stratified by PAH category at baseline||||0.725|0.013|0.0047
70871779|NCT03761277|141228933|NON_INFERIORITY|This analysis was to demonstrate pain intensity scores (VAS) at the 6-Month Visit is non-inferior to VAS at Baseline, i.e., the change in pain intensity is not greater than 0 by more than 10 points from Baseline to the 6-Month Visit, with change calculated as 6-Month - Baseline.|Mean Difference (Final Values)|-15.0|STANDARD_DEVIATION|25.0|<|0.001|ONE_SIDED|97.5||-7.1|||Wilcoxon Signed Rank test|||This analysis was to demonstrate pain intensity scores (VAS) at the 6-Month Visit is non-inferior to VAS at Baseline, i.e., the change in pain intensity is not greater than 0 by more than 10 points from Baseline to the 6-Month Visit.|Due to non-normality, the non-inferiority test was conducted using a Wilcoxon Signed Rank test, rather than a one-sample t-test. Mean reduction in VAS and the upper 97.5% confidence limit are presented, but the change from baseline was evaluated using non-parametric analysis methods.|-7.1||< 0.001
70871780|NCT03761277|141228933|SUPERIORITY|This analysis was to demonstrate pain intensity scores (VAS) at the 6-Month Visit are less than VAS at Baseline, i.e., the reduction in pain intensity is less than 0 from Baseline to the 6-Month Visit, with change calculated as 6-Month - Baseline.|Mean Difference (Final Values)|-15.0|STANDARD_DEVIATION|25.0|<|0.001|TWO_SIDED|95.0|-22.7|-7.1|||Wilcoxon Signed Rank test|||This analysis was to demonstrate pain intensity scores (VAS) at the 6-Month Visit are less than VAS at Baseline, i.e., the reduction in pain intensity is less than 0 from Baseline to the 6-Month Visit.|Due to non-normality, the superiority test was conducted using a Wilcoxon Signed Rank test, rather than a one-sample t-test. Mean reduction in VAS and 95% confidence interval are presented, but the change from baseline was evaluated using non-parametric analysis methods.|-7.1|-22.7|< 0.001
70871781|NCT00004978|141228936|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.94||||0.55|TWO_SIDED|95.0|0.75|1.16||P-value is 2-sided using an alpha of .05.|Regression, Cox|Hazard ratio is from unadjusted proportional hazards regression model.|HR is for rIL-2 vs control.|||1.16|0.75|.55
70871782|NCT00004978|141228937|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.94||||0.62|TWO_SIDED|95.0|0.74|1.2|||Regression, Cox|||||1.20|0.74|.62
70871783|NCT00004978|141228938|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.42|TWO_SIDED|95.0|0.69|1.17|||Regression, Cox|||||1.17|0.69|.42
70871784|NCT00004978|141228939|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.41|TWO_SIDED|95.0|0.73|1.14|||Regression, Cox|||||1.14|0.73|.41
70871785|NCT00004978|141228940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|159.0|||||TWO_SIDED|95.0|145.0|174.0|||||treatment difference (rIL2 - no rIL2) estimated from a longitudinal model that considers CD4+ measured at followup visits|||174|145|
70871786|NCT00004978|141228942|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.94||||0.07|TWO_SIDED|95.0|0.88|1.0|||Regression, Cox|Hazard ratio (rIL-2 vs. no rIL-2) for first change in antiretroviral treatment.||||1.00|0.88|.07
70871787|NCT00004978|141228943|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.23||||0.003|TWO_SIDED|95.0|1.07|1.41|||Regression, Cox||HR (IL-2 vs control) for first grade 4 event, ITT analysis.|||1.41|1.07|.003
70871788|NCT00004978|141228944|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97||95.0|||||Chi-squared|||||||.97
70871789|NCT00004978|141228945|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.96||||0.74|TWO_SIDED|95.0|0.76|1.22|||Regression, Cox|||||1.22|0.76|.74
70871790|NCT02064894|141228948|SUPERIORITY_OR_OTHER|||||||0.81|||||||Cochran-Mantel-Haenszel|||||||0.81
70871791|NCT02864498|141228950|SUPERIORITY|||||||0.557|||||||General Linear Model|||||||0.5570
70871792|NCT02864498|141228950|SUPERIORITY|||||||0.8774|||||||General Linear Model|||||||0.8774
70871793|NCT04950998|141228957|SUPERIORITY||Mean Difference (Final Values)|604.07|STANDARD_DEVIATION|2560.36||0.376|TWO_SIDED|95.0|-813.815|2021.95|||t-test, 2 sided|||||2021.95|-813.815|0.376
70871794|NCT04950998|141228958|SUPERIORITY||Mean Difference (Final Values)|-35.019|STANDARD_DEVIATION|172.168||0.444|TWO_SIDED|95.0|-130.36|60.324|||t-test, 2 sided|||||60.324|-130.36|.444
70871795|NCT01537393|141228985|NON_INFERIORITY|The two treatment groups will be declared equivalent if the one-sided 95% confidence interval for the difference in proportions excludes the pre-defined non-inferiority limit of 4%.|Risk Difference (RD)|3.2|||||ONE_SIDED|95.0||5.4|||||||The bootstrap re-sampling technique were used to account for potentially correlated data from donors who donated both corneas in this study and potentially correlated data from 2 study eyes of the same study participant. The technique will sample with replacement from the observed dataset. Confidence intervals will be calculated using the bias-corrected and accelerated method. The number of bootstraps will be 100,000.|5.4||
70871796|NCT01537393|141228985|OTHER|Confounding and treatment interactions were assessed in Cox proportional hazards regression models|Hazard Ratio (HR)|1.71||||0.02|TWO_SIDED|95.0|1.09|2.71|||Regression, Cox|Unadjusted Hazard Ratio||||2.71|1.09|0.02
70954124|NCT01262677|141410829|SUPERIORITY||LS Mean Difference|-2.7||||0.3972|TWO_SIDED|95.0|-9.1|3.6||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: snoring score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||3.6|-9.1|0.3972
70954125|NCT01262677|141410829|SUPERIORITY||LS Mean Difference|6.7||||0.0319|TWO_SIDED|95.0|0.6|12.9||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: snoring score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||12.9|0.6|0.0319
70954126|NCT01262677|141410830|SUPERIORITY||LS Mean Difference|0.8||||0.7708|TWO_SIDED|95.0|-4.4|5.9||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: awaken short of breath or with headache score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||5.9|-4.4|0.7708
70871797|NCT01537393|141228986|OTHER|The primary analysis to assess the effect of PT on 3 year ECD was conducted with a mixed linear model adjusting for baseline ECD, corneal diagnosis, and potential confounders, including storage solution, preparation by eye bank vs surgeon, and accounting for correlated data from participants with 2 study eyes or 2 corneas from the same donor.|Mean Difference (Final Values)|73.0||||0.03|TWO_SIDED|95.0|8.0|138.0|||Mixed Models Analysis|Adjusted for baseline ECD, diagnosis, storage solution, preparation by eye bank/surgeon, participants with 2 study eyes/ 2 corneas from the same donor||||138|8|0.03
70871798|NCT04518293|141228987|OTHER|The difference between GMRx2 and dual-TA at Week 12 was estimated using a mixed model for repeated measures (MMRM).|LS Means Difference|-5.44|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001|TWO_SIDED|95.0|-6.774|-4.107|||MIANALYZE procedure|||The LS means (LSM) difference (95% CI) in home seated SBP reduction was calculated between GMRx2 and dual-TA arms.||-4.107|-6.774|<.0001
70871799|NCT04518293|141228987|OTHER|The difference between GMRx2 and dual-TI at Week 12 was estimated using a MMRM.|LS Means Difference|-2.49|STANDARD_ERROR_OF_MEAN|0.63|<|0.0001|TWO_SIDED|95.0|-3.723|-1.251|||MIANALYZE procedure|||The LSM difference (95% CI) in home SBP reduction was calculated between GMRx2 and dual-TI arms.||-1.251|-3.723|<.0001
70871800|NCT04518293|141228987|OTHER|The difference between GMRx2 and dual-AI at Week 12 was estimated using a MMRM.|LS Means Difference|-4.42|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001|TWO_SIDED|95.0|-5.758|-3.091|||MIANALYZE procedure|||The LSM difference (95% CI) in home SBP reduction was calculated between GMRx2 and dual-AI arms.||-3.091|-5.758|<.0001
70871801|NCT04518293|141228988|OTHER|The difference between GMRx2 and dual-TA at Week 12 was estimated using a MMRM.|LS Means Difference|-5.6|STANDARD_ERROR_OF_MEAN|0.863|<|0.0001|TWO_SIDED|95.0|-7.307|-3.902|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 between dual-TA arms.||-3.902|-7.307|<.0001
70871802|NCT04518293|141228988|OTHER|The difference between GMRx2 and dual-TI at Week 12 was estimated using a MMRM.|LS Means Difference|-4.33|STANDARD_ERROR_OF_MEAN|1.212||0.0005|TWO_SIDED|95.0|-6.718|-1.933|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 and dual-TI arms.||-1.933|-6.718|0.0005
70871803|NCT04518293|141228988|OTHER|The difference between GMRx2 and dual-AI at Week 12 was estimated using a MMRM.|LS Means Difference|-6.33|STANDARD_ERROR_OF_MEAN|0.837|<|0.0001|TWO_SIDED|95.0|-7.984|-4.68|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 and dual-AI arms.||-4.680|-7.984|<.0001
70871804|NCT04518293|141228989|OTHER|The difference between GMRx2 and dual-TA at Week 6 was estimated using MMRM.|LS Means Difference|-5.01|STANDARD_ERROR_OF_MEAN|0.858|<|0.0001|TWO_SIDED|95.0|-6.703|-3.317|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 and dual-TA arms.||-3.317|-6.703|<.0001
70871805|NCT04518293|141228989|OTHER|The difference between GMRx2 and dual-TI at Week 6 was estimated using MMRM.|LS Means Difference|-3.5|STANDARD_ERROR_OF_MEAN|0.91||0.0002|TWO_SIDED|95.0|-5.293|-1.7|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 and dual-TI arms.||-1.700|-5.293|0.0002
70871806|NCT04518293|141228989|OTHER|The difference between GMRx2 and dual-AI at Week 6 was estimated using MMRM.|LS Means Difference|-5.35|STANDARD_ERROR_OF_MEAN|0.965|<|0.0001|TWO_SIDED|95.0|-7.251|-3.444|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 and dual-AI arms.||-3.444|-7.251|<.0001
70871807|NCT04518293|141228990|OTHER|The difference between GMRx2 and dual-TA at Week 12 was estimated using MMRM.|LS Means Difference|-3.72|STANDARD_ERROR_OF_MEAN|0.49|<|0.0001|TWO_SIDED|95.0|-4.692|-2.757|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic DBP reduction was calculated between GMRx2 and dual-TA arms.||-2.757|-4.692|<.0001
70871808|NCT04518293|141228990|OTHER|The difference between GMRx2 and dual-TI at Week 12 was estimated using MMRM.|LS Means Difference|-3.51|STANDARD_ERROR_OF_MEAN|0.702|<|0.0001|TWO_SIDED|95.0|-4.897|-2.128|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic DBP reduction was calculated between GMRx2 and dual-TI arms.||-2.128|-4.897|<.0001
70871809|NCT04518293|141228990|OTHER|The difference between GMRx2 and dual-AI at Week 12 was estimated using MMRM.|LS Means Difference|-4.5|STANDARD_ERROR_OF_MEAN|0.665|<|0.0001|TWO_SIDED|95.0|-5.812|-3.189|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic DBP reduction was calculated between GMRx2 and dual-AI arms.||-3.189|-5.812|<.0001
70871810|NCT04518293|141228991|OTHER|The difference between GMRx2 and dual-TA at Week 6 was estimated using MMRM.|LS Means Difference|-2.43|STANDARD_ERROR_OF_MEAN|0.487|<|0.0001|TWO_SIDED|95.0|-3.392|-1.469|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic DBP reduction was calculated between GMRx2 and dual-TA arms.||-1.469|-3.392|<.0001
70871811|NCT04518293|141228991|OTHER|The difference between GMRx2 and dual-TI at Week 6 was estimated using MMRM.|LS Means Difference|-2.29|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|-3.371|-1.201|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic DBP reduction was calculated between GMRx2 and dual-TI arms.||-1.201|-3.371|<.0001
70871812|NCT04518293|141228991|OTHER|The difference between GMRx2 and dual-AI at Week 6 was estimated using MMRM.|LS Means Difference|-3.77|STANDARD_ERROR_OF_MEAN|0.562|<|0.0001|TWO_SIDED|95.0|-4.882|-2.664|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic DBP reduction was calculated between GMRx2 and dual-AI arms.||-2.664|-4.882|<.0001
70871813|NCT04518293|141228992|OTHER||Risk Difference (RD)|12.52||||0.0003|TWO_SIDED|95.0|5.63|19.487|||Wald test|||The difference between GMRx2 and TA at Week 12 was estimated using Generalized Estimating Equation.||19.487|5.630|0.0003
70871814|NCT04518293|141228992|OTHER||Risk Difference (RD)|13.36||||0.0001|TWO_SIDED|95.0|6.392|20.394|||Wald test|||The difference between GMRx2 and TI at Week 12 was estimated using Generalized Estimating Equation.||20.394|6.392|0.0001
70871815|NCT04518293|141228992|OTHER||Risk Difference (RD)|20.97|||<|0.0001|TWO_SIDED|95.0|13.812|28.013|||Wald test|||The difference between GMRx2 and AI at Week 12 was estimated using Generalized Estimating Equation.||28.013|13.812|<.0001
70871816|NCT04518293|141228993|OTHER||Risk Difference (RD)|10.31||||0.0044|TWO_SIDED|95.0|3.044|17.535|||Wald test|||The difference between GMRx2 and TA at Week 6 was estimated using Generalized Estimating Equation.||17.535|3.044|0.0044
70871817|NCT04518293|141228993|OTHER||Risk Difference (RD)|8.08||||0.0262|TWO_SIDED|95.0|0.804|15.373|||Wald test|||The difference between GMRx2 and TI at Week 6 was estimated using Generalized Estimating Equation.||15.373|0.804|0.0262
70871818|NCT04518293|141228993|OTHER||Risk Difference (RD)|18.59|||<|0.0001|TWO_SIDED|95.0|11.201|25.746|||Wald test|||The difference between GMRx2 and AI at Week 6 was estimated using Generalized Estimating Equation.||25.746|11.201|<.0001
70871819|NCT04518293|141228994|OTHER||Risk Difference (RD)|16.51|||<|0.0001|TWO_SIDED|95.0|9.707|22.837|||Wald test|||The difference between GMRx2 and TA at Week 12 was estimated using Generalized Estimating Equation.||22.837|9.707|<.0001
70871820|NCT04518293|141228994|OTHER||Risk Difference (RD)|12.03||||0.0004|TWO_SIDED|95.0|4.982|18.658|||Wald test|||The difference between GMRx2 and TI at Week 12 was estimated using Generalized Estimating Equation.||18.658|4.982|0.0004
70871821|NCT04518293|141228994|OTHER||Risk Difference (RD)|18.19|||<|0.0001|TWO_SIDED|95.0|11.412|24.432|||Wald test|||The difference between GMRx2 and AI at Week 12 was estimated using Generalized Estimating Equation.||24.432|11.412|<.0001
70871822|NCT04518293|141228995|OTHER||Risk Difference (RD)|10.45||||0.0007|TWO_SIDED|95.0|3.993|16.433|||Wald test|||The difference between GMRx2 and TA at Week 6 was estimated using Generalized Estimating Equation.||16.433|3.993|0.0007
70871823|NCT04518293|141228995|OTHER||Risk Difference (RD)|8.93||||0.0046|TWO_SIDED|95.0|2.337|15.058|||Wald test|||The difference between GMRx2 and TI at Week 6 was estimated using Generalized Estimating Equation.||15.058|2.337|0.0046
70871824|NCT04518293|141228995|OTHER||Risk Difference (RD)|12.19|||<|0.0001|TWO_SIDED|95.0|5.792|18.073|||Wald test|||||18.073|5.792|<.0001
70871825|NCT04518293|141228996|OTHER|The difference between GMRx2 and dual-TA at Week 6 was estimated using MMRM.|LS Means Difference|-6.11|STANDARD_ERROR_OF_MEAN|0.495|<|0.0001|TWO_SIDED|95.0|-7.086|-5.144|||Mixed Models Analysis|||The LSM difference (95% CI) in home SBP reduction was calculated between GMRx2 and dual-TA arms.||-5.144|-7.086|<.0001
70871826|NCT04518293|141228996|OTHER|The difference between GMRx2 and dual-TI at Week 6 was estimated using MMRM.|LS Means Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.543|<|0.0001|TWO_SIDED|95.0|-4.06|-1.932|||Mixed Models Analysis|||The LSM difference (95% CI) in home SBP reduction was calculated between GMRx2 and dual-TI arms.||-1.932|-4.060|<.0001
70871827|NCT04518293|141228996|OTHER|The difference between GMRx2 and dual-AI at Week 6 was estimated using MMRM.|LS Means Difference|-5.09|STANDARD_ERROR_OF_MEAN|0.603|<|0.0001|TWO_SIDED|95.0|-6.274|-3.912|||Mixed Models Analysis|||The LSM difference (95% CI) in home SBP reduction was calculated between GMRx2 and dual-AI arms.||-3.912|-6.274|<.0001
70871828|NCT04518293|141228997|OTHER|The difference between GMRx2 and dual-TA at Week 12 was estimated using MMRM.|LS Means Difference|-3.35|STANDARD_ERROR_OF_MEAN|0.364|<|0.0001|TWO_SIDED|95.0|-4.069|-2.632|||Mixed Models Analysis|||The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-TA arms.||-2.632|-4.069|<.0001
70871829|NCT04518293|141228997|OTHER|The difference between GMRx2 and dual-TI at Week 12 was estimated using MMRM.|LS Means Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.456|<|0.0001|TWO_SIDED|95.0|-2.998|-1.2|||Mixed Models Analysis|||The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-TI arms.||-1.200|-2.998|<.0001
70954127|NCT01262677|141410830|SUPERIORITY||LS Mean Difference|2.4||||0.356|TWO_SIDED|95.0|-2.7|7.4||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: awaken short of breath or with headache score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||7.4|-2.7|0.3560
70954128|NCT01262677|141410831|SUPERIORITY||LS Mean Difference|0.2||||0.1129|TWO_SIDED|95.0|-0.1|0.5||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: quantity of sleep at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||0.5|-0.1|0.1129
70954129|NCT01262677|141410831|SUPERIORITY||LS Mean Difference|0.0||||0.9388|TWO_SIDED|95.0|-0.3|0.3||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: quantity of sleep at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||0.3|-0.3|0.9388
70954130|NCT01262677|141410832|SUPERIORITY||LS Mean Difference|-0.4||||0.9053|TWO_SIDED|95.0|-7.5|6.6||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep adequacy score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||6.6|-7.5|0.9053
70954131|NCT01262677|141410832|SUPERIORITY||LS Mean Difference|-1.6||||0.6371|TWO_SIDED|95.0|-8.5|5.2||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep adequacy score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||5.2|-8.5|0.6371
70954132|NCT01262677|141410833|SUPERIORITY||LS Mean Difference|-6.4||||0.0119|TWO_SIDED|95.0|-11.4|-1.4||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep somnolence score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||-1.4|-11.4|0.0119
70954133|NCT01262677|141410833|SUPERIORITY||LS Mean Difference|0.0||||0.9909|TWO_SIDED|95.0|-4.9|4.8||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep somnolence score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||4.8|-4.9|0.9909
70954134|NCT01262677|141410834|SUPERIORITY||LS Mean Difference|-1.1||||0.5903|TWO_SIDED|95.0|-5.0|2.8||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep problems index I score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||2.8|-5.0|0.5903
70954135|NCT01262677|141410834|SUPERIORITY||LS Mean Difference|0.7||||0.7126|TWO_SIDED|95.0|-3.1|4.5||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep problems index I score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||4.5|-3.1|0.7126
70954136|NCT01262677|141410835|SUPERIORITY||LS Mean Difference|-2.1||||0.2431|TWO_SIDED|95.0|-5.8|1.5||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep problems index II score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||1.5|-5.8|0.2431
70954137|NCT01262677|141410835|SUPERIORITY||LS Mean Difference|0.3||||0.8654|TWO_SIDED|95.0|-3.2|3.8||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep problems index II score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||3.8|-3.2|0.8654
70954138|NCT01262677|141410836|SUPERIORITY||Odds Ratio (OR)|1.36||||0.3241|TWO_SIDED|95.0|0.74|2.5||Statistical testing was done at alpha = 0.05 level, two-sided.|Regression, Logistic|||Logistic regression model was used to calculate the p-value, with the fixed effects for sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR), average hours per night of sleep at baseline as a coninuous covariate, and optimal sleep at Week 14 as dependent variable. No adjustments for multiplicity were taken.||2.50|0.74|0.3241
70954139|NCT01262677|141410836|SUPERIORITY||Odds Ratio (OR)|0.96||||0.8932|TWO_SIDED|95.0|0.54|1.71||Statistical testing was done at alpha = 0.05 level, two-sided.|Regression, Logistic|||Logistic regression model was used to calculate the p-value, with the fixed effects for sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR), average hours per night of sleep at baseline as a coninuous covariate, and optimal sleep at Week 14 as dependent variable. No adjustments for multiplicity were taken.||1.71|0.54|0.8932
70954140|NCT02055781|141410859|SUPERIORITY|||||||0.0011|||||||Fisher Exact|||BAT arm compared to pooled pacritinib arms (QD + BID - ITT Efficacy)||||0.0011
70954141|NCT02055781|141410859|SUPERIORITY|||||||0.0173|||||||Fisher Exact|||||||0.0173
70954142|NCT02055781|141410859|SUPERIORITY|||||||0.0007|||||||Fisher Exact|||||||0.0007
70871830|NCT04518293|141228997|OTHER|The difference between GMRx2 and dual-AI at Week 12 was estimated using MMRM.|LS Means Difference|-3.63|STANDARD_ERROR_OF_MEAN|0.499|<|0.0001|TWO_SIDED|95.0|-4.617|-2.649|||Mixed Models Analysis|||The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-AI arms.||-2.649|-4.617|<.0001
70871831|NCT04518293|141228998|OTHER|The difference between GMRx2 and dual-TA at Week 6 was estimated using MMRM.|LS Means Difference|-3.52|STANDARD_ERROR_OF_MEAN|0.311|<|0.0001|TWO_SIDED|95.0|-4.137|-2.908|||Mixed Models Analysis|||The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-TA arms.||-2.908|-4.137|<.0001
70871832|NCT04518293|141228998|OTHER|The difference between GMRx2 and dual-TI at Week 6 was estimated using MMRM.|LS Means Difference|-2.09|STANDARD_ERROR_OF_MEAN|0.361|<|0.0001|TWO_SIDED|95.0|-2.803|-1.376|||Mixed Models Analysis|||The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-TI arms.||-1.376|-2.803|<.0001
70871833|NCT04518293|141228998|OTHER|The difference between GMRx2 and dual-AI at Week 6 was estimated using MMRM.|LS Means Difference|-3.58|STANDARD_ERROR_OF_MEAN|0.439|<|0.0001|TWO_SIDED|95.0|-4.446|-2.713|||Mixed Models Analysis|||The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-AI arms.||-2.713|-4.446|<.0001
70871834|NCT04518293|141228999|OTHER|The difference between GMRx2 and dual-TA at Week 12 was estimated using MMRM.|LS Means Difference|-5.58|STANDARD_ERROR_OF_MEAN|0.713|<|0.0001|TWO_SIDED|95.0|-6.983|-4.169|||Mixed Models Analysis|||The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-TA arms.||-4.169|-6.983|<.0001
70871835|NCT04518293|141228999|OTHER|The difference between GMRx2 and dual-TI at Week 12 was estimated using MMRM.|LS Means Difference|-1.91|STANDARD_ERROR_OF_MEAN|0.662||0.0043|TWO_SIDED|95.0|-3.218|-0.607|||Mixed Models Analysis|||The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-TI arms.||-0.607|-3.218|0.0043
70871836|NCT04518293|141228999|OTHER|The difference between GMRx2 and dual-AI at Week 12 was estimated using MMRM.|LS Means Difference|-3.74|STANDARD_ERROR_OF_MEAN|0.745|<|0.0001|TWO_SIDED|95.0|-5.214|-2.274|||Mixed Models Analysis|||The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-AI arms.||-2.274|-5.214|<.0001
70871837|NCT04518293|141229000|OTHER|The difference between GMRx2 and dual-TA at Week 6 was estimated using MMRM.|LS Means Difference|-6.25|STANDARD_ERROR_OF_MEAN|0.546|<|0.0001|TWO_SIDED|95.0|-7.324|-5.168|||Mixed Models Analysis|||The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-TA arms.||-5.168|-7.324|<.0001
70871838|NCT04518293|141229000|OTHER|The difference between GMRx2 and dual-TI at Week 6 was estimated using MMRM.|LS Means Difference|-2.72|STANDARD_ERROR_OF_MEAN|0.616|<|0.0001|TWO_SIDED|95.0|-3.941|-1.507|||Mixed Models Analysis|||The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-TI arms.||-1.507|-3.941|<.0001
70871839|NCT04518293|141229000|OTHER|The difference between GMRx2 and dual-AI at Week 6 was estimated using MMRM.|LS Means Difference|-4.43|STANDARD_ERROR_OF_MEAN|0.537|<|0.0001|TWO_SIDED|95.0|-5.489|-3.368|||Mixed Models Analysis|||The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-AI arms.||-3.368|-5.489|<.0001
70871840|NCT04518293|141229001|OTHER||Risk Difference (RD)|14.79|||<|0.0001|TWO_SIDED|95.0|7.749|21.824|||Wald test|||The difference between GMRx2 and TA at Week 12 was estimated using Generalized Estimating Equation.||21.824|7.749|<.0001
70871841|NCT04518293|141229001|OTHER||Risk Difference (RD)|8.46||||0.0146|TWO_SIDED|95.0|1.58|15.501|||Wald test|||The difference between GMRx2 and TI at Week 12 was estimated using Generalized Estimating Equation.||15.501|1.580|0.0146
70871842|NCT04518293|141229001|OTHER||Risk Difference (RD)|16.07|||<|0.0001|TWO_SIDED|95.0|8.953|23.171|||Wald test|||The difference between GMRx2 and AI at Week 12 was estimated using Generalized Estimating Equation.||23.171|8.953|<.0001
70871843|NCT04518293|141229002|OTHER||Risk Difference (RD)|18.11|||<|0.0001|TWO_SIDED|95.0|10.778|25.226|||Wald test|||The difference between GMRx2 and TA at Week 6 was estimated using Generalized Estimating Equation.||25.226|10.778|<.0001
70871844|NCT04518293|141229002|OTHER||Risk Difference (RD)|6.64||||0.0674|TWO_SIDED|95.0|-0.613|13.926|||Wald test|||The difference between GMRx2 and TI at Week 12 was estimated using Generalized Estimating Equation.||13.926|-0.613|0.0674
70871845|NCT04518293|141229002|OTHER||Risk Difference (RD)|18.23|||<|0.0001|TWO_SIDED|95.0|10.839|25.392|||Wald test|||The difference between GMRx2 and AI at Week 12 was estimated using Generalized Estimating Equation.||25.392|10.839|<.0001
70871846|NCT04518293|141229003|OTHER||Risk Difference (RD)|17.25|||<|0.0001|TWO_SIDED|95.0|9.902|24.286|||Wald test|||The difference between GMRx2 and TA at Week 12 was estimated using Generalized Estimating Equation.||24.286|9.902|<.0001
70871847|NCT04518293|141229003|OTHER||Risk Difference (RD)|12.06||||0.001|TWO_SIDED|95.0|4.632|19.293|||Wald test|||The difference between GMRx2 and TI at Week 12 was estimated using Generalized Estimating Equation.||19.293|4.632|0.0010
70871848|NCT04518293|141229003|OTHER||Risk Difference (RD)|22.93|||<|0.0001|TWO_SIDED|95.0|15.622|29.796|||Wald test|||The difference between GMRx2 and AI at Week 12 was estimated using Generalized Estimating Equation.||29.796|15.622|<.0001
70871849|NCT04518293|141229004|OTHER||Risk Difference (RD)|18.59|||<|0.0001|TWO_SIDED|95.0|11.579|25.124|||Wald test|||The difference between GMRx2 and TA at Week 6 was estimated using Generalized Estimating Equation.||25.124|11.579|<.0001
70871850|NCT04518293|141229004|OTHER||Risk Difference (RD)|12.22||||0.0005|TWO_SIDED|95.0|4.963|19.123|||Wald test|||The difference between GMRx2 and TI at Week 6 was estimated using Generalized Estimating Equation.||19.123|4.963|0.0005
70871851|NCT04518293|141229004|OTHER||Risk Difference (RD)|16.2|||<|0.0001|TWO_SIDED|95.0|9.06|22.914|||Wald test|||The difference between GMRx2 and AI at Week 6 was estimated using Generalized Estimating Equation.||22.914|9.060|<.0001
70871852|NCT04518293|141229005|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.93|||||TWO_SIDED|95.0|-1.529|2.768||||||The Risk difference (95% CI) in percentage of participants discontinuing trial medication due to AE/SAE at Week 12 was calculated between GMRx2 and dual-TA arms.||2.768|-1.529|
70871853|NCT04518293|141229005|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.55|||||TWO_SIDED|95.0|-2.098|2.475||||||The Risk difference (95% CI) in percentage of participants discontinuing trial medication due to AE/SAE at Week 12 was calculated between GMRx2 and dual-TI arms.||2.475|-2.098|
70954143|NCT02055781|141410860|SUPERIORITY|||||||0.0791|||||||Fisher Exact|||BAT arm compared to pooled pacritinib arms (QD + BID - ITT Efficacy)||||0.0791
70954144|NCT02055781|141410860|SUPERIORITY|||||||0.6524|||||||Fisher Exact|||||||0.6524
70871854|NCT04518293|141229005|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.55|||||TWO_SIDED|95.0|-2.098|2.475||||||The Risk difference (95% CI) in percentage of participants discontinuing trial medication due to AE/SAE at Week 12 was calculated between GMRx2 and dual-AI arms.||2.475|-2.098|
70871855|NCT04518293|141229011|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|4.07|||||TWO_SIDED|95.0|0.494|7.116||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 12 was calculated between GMRx2 and dual-TA arms.||7.116|0.494|
70871856|NCT04518293|141229011|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.38|||||TWO_SIDED|95.0|-3.927|4.02||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 12 was calculated between GMRx2 and dual-TI arms.||4.020|-3.927|
70871857|NCT04518293|141229011|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|3.64|||||TWO_SIDED|95.0|-0.07|6.764||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 12 was calculated between GMRx2 and dual-AI arms.||6.764|-0.070|
70871858|NCT04518293|141229012|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|2.59|||||TWO_SIDED|95.0|-0.5|5.136||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 6 was calculated between GMRx2 and dual-TA arms.||5.136|-0.500|
70871859|NCT04518293|141229012|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|1.82|||||TWO_SIDED|95.0|-1.513|4.517||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 6 was calculated between GMRx2 and dual-TI arms.||4.517|-1.513|
70871860|NCT04518293|141229012|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.73|||||TWO_SIDED|95.0|-2.855|3.633||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 6 was calculated between GMRx2 and dual-AI arms.||3.633|-2.855|
70871861|NCT04518293|141229013|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.06|||||TWO_SIDED|95.0|-3.911|3.129||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 12 was calculated between GMRx2 and dual-TA arms.||3.129|-3.911|
70871862|NCT04518293|141229013|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.53|||||TWO_SIDED|95.0|-4.519|2.744||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 12 was calculated between GMRx2 and dual-TI arms.||2.744|-4.519|
70871863|NCT04518293|141229013|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.55|||||TWO_SIDED|95.0|-3.228|3.647||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 12 was calculated between GMRx2 and dual-AI arms.||3.647|-3.228|
70871864|NCT04518293|141229014|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.25|||||TWO_SIDED|95.0|-3.993|2.816||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 6 was calculated between GMRx2 and dual-TA arms.||2.816|-3.993|
70871865|NCT04518293|141229014|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|1.82|||||TWO_SIDED|95.0|-1.513|4.517||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 6 was calculated between GMRx2 and dual-TI arms.||4.517|-1.513|
70871866|NCT04518293|141229014|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.72|||||TWO_SIDED|95.0|-4.596|2.44||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 6 was calculated between GMRx2 and dual-TI arms.||2.440|-4.596|
70871867|NCT04518293|141229015|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|6.72|||||TWO_SIDED|95.0|4.196|9.222||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 12 was calculated between GMRx2 and dual-TA arms.||9.222|4.196|
70871868|NCT04518293|141229015|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|2.0|||||TWO_SIDED|95.0|-1.883|5.257||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 12 was calculated between GMRx2 and dual-TI arms.||5.257|-1.883|
70871869|NCT04518293|141229015|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-5.97|||||TWO_SIDED|95.0|-10.979|-1.6||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 12 was calculated between GMRx2 and dual-AI arms.||-1.600|-10.979|
70871870|NCT04518293|141229016|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|3.13|||||TWO_SIDED|95.0|0.123|5.632||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 6 was calculated between GMRx2 and dual-TA arms.||5.632|0.123|
70871871|NCT04518293|141229016|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|1.28|||||TWO_SIDED|95.0|-2.245|4.134||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 6 was calculated between GMRx2 and dual-TI arms.||4.134|-2.245|
70871872|NCT04518293|141229016|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-2.71|||||TWO_SIDED|95.0|-6.968|0.819||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 6 was calculated between GMRx2 and dual-AI arms.||0.819|-6.968|
70871873|NCT04518293|141229017|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.91|||||TWO_SIDED|95.0|-0.863|2.231||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 12 was calculated between GMRx2 and dual-TA arms.||2.231|-0.863|
70871874|NCT04518293|141229017|OTHER||Risk Difference (RD)|0.91|||||TWO_SIDED|95.0|-0.897|2.231||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 12 was calculated between GMRx2 and dual-TI arms.||2.231|-0.897|
70954145|NCT02055781|141410860|SUPERIORITY|||||||0.0106|||||||Fisher Exact|||||||0.0106
70954146|NCT03446781|141410861|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||0.002
70954147|NCT03446781|141410862|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
70954148|NCT03446781|141410863|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
70954149|NCT03446781|141410864|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
70871875|NCT04518293|141229017|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.55|||||TWO_SIDED|95.0|-1.494|1.913||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 12 was calculated between GMRx2 and dual-AI arms.||1.913|-1.494|
70954150|NCT03446781|141410865|SUPERIORITY|||||||0.033|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||0.033
70954151|NCT03446781|141410866|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
70954152|NCT03446781|141410867|SUPERIORITY||||||<|0.001|||||||ANCOVA|With factors of treatment group and analysis center adjusted for baseline values in the model||CCH 0.84 mg/Buttock versus Placebo||||<0.001
70954153|NCT03446781|141410868|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
70954154|NCT03446781|141410869|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
70954155|NCT01638429|141410892|SUPERIORITY_OR_OTHER|||||||0.16|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.16
70954156|NCT01638429|141410894|SUPERIORITY_OR_OTHER|||||||0.028|||||||t-test, 2 sided|||P-value is comparing change in methane eradiacators before and after treatment to change in methane non-eradiacators before and after treatment||||0.028
70954157|NCT01638429|141410895|SUPERIORITY_OR_OTHER|||||||0.01|||||||t-test, 2 sided|||P-value is comparing change in methane eradiacators before and after treatment to change in methane non-eradiacators before and after treatment||||0.01
70954158|NCT01638429|141410896|SUPERIORITY_OR_OTHER|||||||0.97|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.97
70871876|NCT04518293|141229018|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.01|||||TWO_SIDED|95.0|-1.931|1.149||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 6 was calculated between GMRx2 and dual-TA arms.||1.149|-1.931|
70871877|NCT04518293|141229018|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-1.979|1.143||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 6 was calculated between GMRx2 and dual-TI arms.||1.143|-1.979|
70954159|NCT01638429|141410896|SUPERIORITY_OR_OTHER|||||||0.85|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.85
71145820|NCT02977403|141785384|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.03|||||TWO_SIDED|95.0|-0.039|0.099||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).||||Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.099|-0.039|
70871878|NCT04518293|141229018|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.36|||||TWO_SIDED|95.0|-1.374|1.453||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 6 was calculated between GMRx2 and dual-AI arms.||1.453|-1.374|
70871879|NCT04518293|141229019|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.39|||||TWO_SIDED|95.0|-2.014|2.087||||||The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 12 was calculated between GMRx2 and dual-TA arms.||2.087|-2.014|
70871880|NCT04518293|141229019|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|1.09|||||TWO_SIDED|95.0|-1.015|2.633||||||The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 12 was calculated between GMRx2 and dual-TI arms.||2.633|-1.015|
70871881|NCT04518293|141229019|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|1.09|||||TWO_SIDED|95.0|-1.015|2.633||||||The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 12 was calculated between GMRx2 and dual-AI arms.||2.633|-1.015|
70871882|NCT04518293|141229020|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.16|||||TWO_SIDED|95.0|-2.501|1.385||||||The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 6 was calculated between GMRx2 and dual-TA arms.||1.385|-2.501|
70871883|NCT04518293|141229020|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.54|||||TWO_SIDED|95.0|-3.078|1.108||||||The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 6 was calculated between GMRx2 and dual-TI arms.||1.108|-3.078|
70954160|NCT01638429|141410897|SUPERIORITY_OR_OTHER|||||||0.61|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.61
70954161|NCT01638429|141410897|SUPERIORITY_OR_OTHER|||||||0.45|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.45
70954162|NCT01638429|141410898|SUPERIORITY_OR_OTHER|||||||0.018|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.018
71145821|NCT02977403|141785384|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.143|||||TWO_SIDED|95.0|-0.335|0.049||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.049|-0.335|
71145822|NCT02977403|141785385|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.016|||||TWO_SIDED|95.0|-0.097|0.066||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.066|-0.097|
71145823|NCT02977403|141785385|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.162|||||TWO_SIDED|95.0|-0.314|-0.01||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||-0.01|-0.314|
71145824|NCT02977403|141785386|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.053|||||TWO_SIDED|95.0|-0.051|0.156||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.156|-0.051|
70954163|NCT01638429|141410898|SUPERIORITY_OR_OTHER|||||||0.14|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.14
70954164|NCT01638429|141410899|SUPERIORITY_OR_OTHER|||||||0.43|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.43
70954165|NCT01638429|141410899|SUPERIORITY_OR_OTHER|||||||0.44|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.44
70954166|NCT01638429|141410900|SUPERIORITY_OR_OTHER|||||||0.13|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.13
70954167|NCT01638429|141410900|SUPERIORITY_OR_OTHER|||||||0.25|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.25
70954168|NCT01638429|141410901|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.29
70954169|NCT01638429|141410901|SUPERIORITY_OR_OTHER|||||||0.27|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.27
70954170|NCT01638429|141410902|SUPERIORITY_OR_OTHER|||||||0.22|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.22
70954171|NCT01638429|141410902|SUPERIORITY_OR_OTHER|||||||0.059|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.059
71145825|NCT02977403|141785386|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.07|||||TWO_SIDED|95.0|-0.251|0.111||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.111|-0.251|
70871884|NCT04518293|141229020|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.18|||||TWO_SIDED|95.0|-2.571|1.37||||||The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 6 was calculated between GMRx2 and dual-AI arms.||1.370|-2.571|
70954172|NCT01638429|141410903|SUPERIORITY_OR_OTHER|||||||0.33|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.33
70954173|NCT01638429|141410903|SUPERIORITY_OR_OTHER|||||||0.075|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.075
70954174|NCT00996476|141410907|SUPERIORITY_OR_OTHER||LS means difference|-2.4|||||TWO_SIDED|95.0|-2.83|-1.97|||ANCOVA||TMC435 50 mg minus PR48 control|Difference in least square (LS) mean change from baseline from the PR48 control group||-1.97|-2.83|
70954175|NCT00996476|141410907|SUPERIORITY_OR_OTHER||LS Means difference|-2.41|||||TWO_SIDED|95.0|-2.85|-1.98|||ANCOVA||TMC435 100 mg minus PR48 control|Difference in least square (LS) mean change from baseline from the PR48 control group||-1.98|-2.85|
70954176|NCT00996476|141410912|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-24.6|||||TWO_SIDED|95.0|-58.3|11.8|||||PR48 control minus TMC12/PR24|The difference in the percentage of participants between The TMC12/PR24 50 mg treatment group and the PR48 control group||11.8|-58.3|
70954177|NCT00996476|141410912|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-27.5|||||TWO_SIDED|95.0|-61.1|9.8|||||PR48 control minus TMC12/PR24|The difference in the percentage of participants between The TMC12/PR24 100 mg treatment group and the PR48 control group||9.8|-61.1|
70954178|NCT00996476|141410912|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-23.3|||||TWO_SIDED|95.0|-59.9|19.4|||||PR48 control minus TMC24/PR24|The difference in the percentage of participants between The TMC24/PR24 50 mg treatment group and the PR48 control group||19.4|-59.9|
70954179|NCT00996476|141410912|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-32.3|||||TWO_SIDED|95.0|-66.6|8.3|||||PR48 control minus TMC24/PR24|The difference in the percentage of participants between The TMC24/PR24 100 mg treatment group and the PR48 control group||8.3|-66.6|
70954180|NCT00734591|141410957|SUPERIORITY_OR_OTHER||Exact method|2.81|||||TWO_SIDED|95.0|0.5|28.46|||||Incidence density ratio confidence interval derived from exact methods utilizing exact binomial limits and ratio of exposures.|||28.46|0.50|
70954181|NCT00734591|141410958|SUPERIORITY_OR_OTHER||Exact method|2.29|||||TWO_SIDED|95.0|0.37|24.01|||||Incidence density ratio confidence interval derived from exact methods utilizing exact binomial limits and ratio of exposures.|||24.01|0.37|
70954182|NCT00734591|141410959|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.81|||||TWO_SIDED|95.0|0.6|1.1||||||||1.10|0.60|
70954183|NCT00734591|141410960|SUPERIORITY_OR_OTHER||Exact method|3.75|||||TWO_SIDED|95.0|1.01|20.68|||||Incidence density ratio confidence interval derived from exact methods utilizing exact binomial limits and ratio of exposures.|||20.68|1.01|
70954184|NCT01072630|141410980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.1302|TWO_SIDED|95.0|-4.67|0.6||All statistical tests were 2-tailed at the 0.05 level of significance.|mixed-model repeated measures (MMRM)|Treatment, visit, treatment-by-visit interaction, concurrent mood-stabilizing medication, and region of the world used as fixed factors.||||0.60|-4.67|0.1302
70954185|NCT01072630|141410980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.135|TWO_SIDED|95.0|-4.51|0.61||All statistical tests were 2-tailed at the 0.05 level of significance.|mixed-model repeated measures (MMRM)|Treatment, visit, treatment-by-visit interaction, concurrent mood-stabilizing medication, and region of the world used as fixed factors.||||0.61|-4.51|0.1350
70954186|NCT01232738|141411003|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.07|TWO_SIDED|95.0|-0.53|0.02|||Chi-squared|||Difference in slope of decline||0.02|-0.53|0.07
70954187|NCT01232738|141411004|SUPERIORITY|||||||0.58|||||||Log Rank|||||||0.58
70954188|NCT00338962|141411013|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||Bonferonni adjustments were applied. Mixed effects models were used to assess changes in PTSD symptoms over time.|Mixed Models Analysis|F=49.633||||||0.00
70954189|NCT00338962|141411015|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||ANOVA|||Gastrointestinal symptoms compared||||0.007
70871885|NCT04518293|141229021|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|10.55|||||TWO_SIDED|95.0|5.422|15.138||||||The Risk difference (95% CI) in percentage of participants with serum sodium \<135mmol/L or \>145 mmol/L, and/or serum potassium \<3.5 mmol/L or \>5.5mmol/L at Week 12 was calculated between GMRx2 and dual-TA arms.||15.138|5.422|
70871886|NCT04518293|141229021|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|3.11|||||TWO_SIDED|95.0|-2.776|8.49||||||The Risk difference (95% CI) in percentage of participants with serum sodium \<135mmol/L or \>145 mmol/L, and/or serum potassium \<3.5 mmol/L or \>5.5mmol/L at Week 12 was calculated between GMRx2 and dual-TI arms.||8.490|-2.776|
70871887|NCT04518293|141229021|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-1.6|||||TWO_SIDED|95.0|-7.807|4.174||||||The Risk difference (95% CI) in percentage of participants with serum sodium \<135mmol/L or \>145 mmol/L, and/or serum potassium \<3.5 mmol/L or \>5.5mmol/L at Week 12 was calculated between GMRx2 and dual-AI arms.||4.174|-7.807|
70871888|NCT04518293|141229022|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|5.47|||||TWO_SIDED|95.0|0.531|9.867||||||The Risk difference (95% CI) in percentage of participants with serum sodium \<135mmol/L or \>145 mmol/L, and/or serum potassium \<3.5 mmol/L or \>5.5mmol/L at Week 6 was calculated between GMRx2 and dual-TA arms.||9.867|0.531|
70871889|NCT04518293|141229022|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|4.92|||||TWO_SIDED|95.0|-0.136|9.397||||||The Risk difference (95% CI) in percentage of participants with serum sodium \<135mmol/L or \>145 mmol/L, and/or serum potassium \<3.5 mmol/L or \>5.5mmol/L at Week 6 was calculated between GMRx2 and dual-TI arms.||9.397|-0.136|
70871890|NCT04518293|141229022|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-1.6|||||TWO_SIDED|95.0|-7.299|3.567||||||The Risk difference (95% CI) in percentage of participants with serum sodium \<135mmol/L or \>145 mmol/L, and/or serum potassium \<3.5 mmol/L or \>5.5mmol/L at Week 6 was calculated between GMRx2 and dual-AI arms.||3.567|-7.299|
70871891|NCT04518293|141229023|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.06||||0.9677|TWO_SIDED|95.0|-3.825|3.019|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 6 was calculated between GMRx2 and dual-TA arms.||3.019|-3.825|0.9677
70954190|NCT03151993|141411040|NON_INFERIORITY|The non-inferiority hypothesis would be declared if the lower limit of the 95% CI for an mRS score of 0-1 on day 90 did not cross the margin of noninferiority of 16%. The non-inferiority hypothesis was tested using Welch's t-test for the primary outcome only.|Odds Ratio (OR)|9.5|||<|0.01|TWO_SIDED|95.0|-1.7|20.7|||Welch's t-test|||||20.7|-1.7|<0.01
70954191|NCT04155047|141411051|SUPERIORITY||Least Squares Mean Difference|-0.323|STANDARD_ERROR_OF_MEAN|0.1861||0.0987|TWO_SIDED|95.0|-0.711|0.066|||Mixed Models Analysis|||||0.066|-0.711|0.0987
70954192|NCT02310100|141411071|OTHER|This is a one-group comparison to a performance goal.|binomial proportion|0.673||||0.0008|ONE_SIDED|95.0|0.608||||Exact binomial|||H0: PE ≤ 54.9% Ha: PE \> 54.9% Where PE is the primary effectiveness endpoint rate.|||0.608|0.0008
70954193|NCT02310100|141411072|OTHER|One group comparison to a performance goal.|binomial proportion|0.081||||0.0013|ONE_SIDED|95.0||0.124|||Exact binomial|||H0: PS ≥ 16.2% Ha: PS \< 16.2% where PS is the primary safety endpoint rate||0.124||0.0013
70954194|NCT00688870|141411073|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.2|||||TWO_SIDED|95.0|-6.8|3.3|||Chan and Zhang|||Common serotypes - serotype 4||3.3|-6.8|
70954195|NCT00688870|141411073|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.3|||Chan and Zhang|||Common serotypes - serotype 6B||4.3|-4.6|
70954196|NCT00688870|141411073|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.2|||||TWO_SIDED|95.0|-6.8|3.3|||Chan and Zhang|||Common serotypes - serotype 9V||3.3|-6.8|
70954197|NCT00688870|141411073|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.3|||Chan and Zhang|||Common serotypes - serotype 14||4.3|-4.6|
70954198|NCT00688870|141411073|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.3|||Chan and Zhang|||Common serotypes - serotype 18C||4.3|-4.6|
70954199|NCT00688870|141411073|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.2|||||TWO_SIDED|95.0|-6.8|3.3|||Chan and Zhang|||Common serotypes - serotype 19F||3.3|-6.8|
70954200|NCT00688870|141411073|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-5.0|||||TWO_SIDED|95.0|-12.3|-0.3|||Chan and Zhang|||Common serotypes - serotype 23F||-0.3|-12.3|
70871892|NCT04518293|141229023|OTHER||Risk Difference (RD)|-2.35||||0.1952|TWO_SIDED|95.0|-6.55|1.125|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 6 was calculated between GMRx2 and dual-TI arms.||1.125|-6.550|0.1952
70954201|NCT00688870|141411073|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|96.3|||||TWO_SIDED|95.0|89.4|99.2|||Chan and Zhang|||Additional serotypes - serotype 1||99.2|89.4|
70871893|NCT04518293|141229023|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.53||||0.7453|TWO_SIDED|95.0|-4.428|2.642|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 6 was calculated between GMRx2 and dual-AI arms.||2.642|-4.428|0.7453
70871894|NCT04518293|141229024|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.12||||0.9415|TWO_SIDED|95.0|-3.657|3.222|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 12 was calculated between GMRx2 and dual-TA arms.||3.222|-3.657|0.9415
70871895|NCT04518293|141229024|OTHER||Risk Difference (RD)|-2.53||||0.1719|TWO_SIDED|95.0|-6.799|1.019|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 12 was calculated between GMRx2 and dual-TI arms.||1.019|-6.799|0.1719
70871896|NCT04518293|141229024|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-2.16||||0.2342|TWO_SIDED|95.0|-6.38|1.326|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 12 was calculated between GMRx2 and dual-AI arms.||1.326|-6.380|0.2342
70954202|NCT00688870|141411073|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|95.1|||||TWO_SIDED|95.0|87.7|98.6|||Chan and Zhang|||Additional serotypes - serotype 3||98.6|87.7|
70954203|NCT00688870|141411073|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|37.2|||||TWO_SIDED|95.0|26.2|48.9|||Chan and Zhang|||Additional serotypes - serotype 5||48.9|26.2|
70954204|NCT00688870|141411073|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|22.9|||||TWO_SIDED|95.0|14.4|33.4|||Chan and Zhang|||Additional serotypes - serotype 6A||33.4|14.4|
70954205|NCT00688870|141411073|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|97.6|||||TWO_SIDED|95.0|91.6|99.7|||Chan and Zhang|||Additional serotypes - serotype 7F||99.7|91.6|
70871897|NCT04518293|141229025|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-2.87||||0.3548|TWO_SIDED|95.0|-9.316|3.215|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 6 was calculated between GMRx2 and dual-TA arms.||3.215|-9.316|0.3548
70871898|NCT04518293|141229025|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.94||||0.7529|TWO_SIDED|95.0|-5.356|6.8|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 6 was calculated between GMRx2 and dual-TI arms.||6.800|-5.356|0.7529
70871899|NCT04518293|141229025|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-2.32||||0.4563|TWO_SIDED|95.0|-8.791|3.772|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 6 was calculated between GMRx2 and dual-AI arms.||3.772|-8.791|0.4563
70871900|NCT04518293|141229026|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.11||||0.9691|TWO_SIDED|95.0|-6.063|5.859|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 12 was calculated between GMRx2 and dual-TA arms.||5.859|-6.063|0.9691
70871901|NCT04518293|141229026|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-3.59||||0.2454|TWO_SIDED|95.0|-10.018|2.462|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 12 was calculated between GMRx2 and dual-TI arms.||2.462|-10.018|0.2454
70871902|NCT04518293|141229026|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.33||||0.913|TWO_SIDED|95.0|-6.583|5.488|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 12 was calculated between GMRx2 and dual-AI arms.||5.488|-6.583|0.9130
70871903|NCT01233258|141229038|SUPERIORITY_OR_OTHER|||||||0.0001||||||No multiplicity adjustment as only 1 primary endpoint.|ANOVA|No adjustment, no transformation of data seemed to be necessary.||Null hypothesis: bleeding rates are equal, alternative hypothesis rates are unequal. Power calculation: Assumption 5 bleeds per year on prophylactic treatment, 15 on on-demand treatment; 2-sided alpha 5% and 90% power.||||0.0001
70871904|NCT01233258|141229039|SUPERIORITY_OR_OTHER|||||||0.0001||||||No multiplicity adjustment as this is not primary endpoint.|ANOVA|No adjustment, no transformation of data seemed to be necessary.||Null hypothesis: bleeding rates are equal, alternative hypothesis rates are unequal. Power calculation not done for this comparison as not primary comparison.||||0.0001
70871905|NCT01233258|141229040|SUPERIORITY_OR_OTHER|||||||0.0001|||||||ANOVA|No adjustment, no transformation of data seemed to be necessary.||Null hypothesis: bleeding rates are equal, alternative hypothesis rates are unequal. Power calculation not done for this comparison as not primary comparison.||||0.0001
70871906|NCT01233258|141229041|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 10%|Median Difference (Net)|-0.0001||||0.0001|ONE_SIDED|95.0|-0.049|||No multiplicity adjustment as not primary endpoint.|Exact Permutation Test for paired sample||Confidence interval calculated with exact Hodges- Lehmann estimates for CS/EP minus CS/ADJ|Null hypothesis: the proportion of bleeds controlled by no more than 2 infusions in the CS/EP group plus 10% is less than the proportion of bleeds controlled by no more than 2 infusions in the CS/ADJ group. Alternative hypothesis: the proportion of bleeds controlled by no more than 2 infusions in the CS/EP group plus 10% is greater than or equal to the proportion of bleeds controlled by no more than 2 infusions in the CS/ADJ group. No power calculation since this is not the primary comparison.|||-0.0490|0.0001
70871907|NCT01146418|141229070|SUPERIORITY_OR_OTHER_LEGACY||Estimated Difference|-1.8|||||TWO_SIDED|95.0|-6.5|3.0|||Clopper-Pearson method|Difference calculated using generalized linear model including covariates for treatment group and age class as stratified (≤38 yrs vs \>38 yrs)||||3.0|-6.5|
70871908|NCT01146418|141229071|SUPERIORITY_OR_OTHER_LEGACY||Estimated difference|-1.2|||||TWO_SIDED|95.0|-5.7|3.4|||Clopper-Pearson method|Difference calculated using generalized linear model including covariates for treatment group and age class as stratified (≤38 yrs vs \>38 yrs)||||3.4|-5.7|
70871909|NCT03789474|141229072|SUPERIORITY|||||||0.443|||||||t-test, 2 sided|||||||.443
70871910|NCT03789474|141229073|SUPERIORITY|||||||0.063|||||||t-test, 2 sided|||||||.063
70871911|NCT03789474|141229074|SUPERIORITY|||||||0.057|||||||t-test, 2 sided|||||||.057
70871912|NCT03789474|141229075|SUPERIORITY|||||||0.038|||||||t-test, 2 sided|||||||.038
70871913|NCT03789474|141229076|SUPERIORITY|||||||0.072|||||||t-test, 2 sided|||||||.072
70871914|NCT03789474|141229077|SUPERIORITY|||||||0.189|||||||t-test, 2 sided|||||||.189
70871915|NCT03789474|141229078|SUPERIORITY|||||||0.358|||||||t-test, 2 sided|||||||.358
70871916|NCT03789474|141229079|SUPERIORITY|||||||0.406|||||||t-test, 2 sided|||||||.406
70871917|NCT03789474|141229080|SUPERIORITY|||||||0.256|||||||t-test, 2 sided|||||||.256
70871918|NCT03789474|141229081|SUPERIORITY|||||||0.066|||||||t-test, 2 sided|||||||.066
70871919|NCT03789474|141229082|SUPERIORITY|||||||0.316|||||||t-test, 2 sided|||||||.316
70871920|NCT03789474|141229083|SUPERIORITY|||||||0.971|||||||t-test, 2 sided|||||||.971
70871921|NCT03789474|141229084|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||.030
70871922|NCT03789474|141229085|SUPERIORITY|||||||0.009|||||||t-test, 2 sided|||||||.009
70871923|NCT03789474|141229086|SUPERIORITY|||||||0.704|||||||t-test, 2 sided|||||||.704
70871924|NCT03789474|141229087|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||.350
70871925|NCT03789474|141229088|SUPERIORITY|||||||0.708|||||||t-test, 2 sided|||||||.708
70871926|NCT03789474|141229089|SUPERIORITY|||||||0.711|||||||t-test, 2 sided|||||||.711
70871927|NCT03789474|141229090|SUPERIORITY|||||||0.956|||||||t-test, 2 sided|||||||.956
70871928|NCT03789474|141229091|SUPERIORITY|||||||0.139|||||||t-test, 2 sided|||||||.139
70871929|NCT03789474|141229092|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||.035
70871930|NCT03789474|141229093|SUPERIORITY|||||||0.502|||||||t-test, 2 sided|||||||.502
70871931|NCT03789474|141229094|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||.350
70871932|NCT03789474|141229095|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||.380
70871933|NCT03789474|141229096|SUPERIORITY|||||||0.914|||||||t-test, 2 sided|||||||.914
70871934|NCT03789474|141229097|SUPERIORITY|||||||0.915|||||||t-test, 2 sided|||||||.915
70871935|NCT03789474|141229098|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|||||||.087
70871936|NCT03789474|141229099|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|||||||.011
70871937|NCT03789474|141229100|SUPERIORITY|||||||0.207|||||||t-test, 2 sided|||||||.207
70871938|NCT03789474|141229101|SUPERIORITY|||||||0.142|||||||t-test, 2 sided|||||||.142
70871939|NCT03789474|141229102|SUPERIORITY|||||||0.021|||||||t-test, 2 sided|||||||.021
70871940|NCT03789474|141229103|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
70871941|NCT03789474|141229104|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||.030
70871942|NCT03789474|141229105|SUPERIORITY|||||||0.048|||||||t-test, 2 sided|||||||.048
70871943|NCT03789474|141229106|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||.047
70954206|NCT00688870|141411073|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.5|||Chan and Zhang|||Additional serotypes - serotype 19A||4.5|-4.6|
70954207|NCT00688870|141411074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.3|||||TWO_SIDED|95.0|-6.9|3.1|||Chan and Zhang|||Common serotypes - serotype 4||3.1|-6.9|
70954208|NCT00688870|141411074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.4|||Chan and Zhang|||Common serotypes - serotype 6B||4.4|-4.6|
70954209|NCT00688870|141411074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.3|||||TWO_SIDED|95.0|-6.9|3.1|||Chan and Zhang|||Common serotypes - serotype 9V||3.1|-6.9|
70871944|NCT03789474|141229107|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||||||.019
70871945|NCT03789474|141229108|SUPERIORITY|||||||0|||||||t-test, 2 sided|||||||.000
70871946|NCT03789474|141229109|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||.004
70871947|NCT03789474|141229110|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||.020
70871948|NCT03789474|141229111|SUPERIORITY|||||||0|||||||t-test, 2 sided|||||||.000
70871949|NCT03789474|141229112|SUPERIORITY|||||||0.053|||||||t-test, 2 sided|||||||.053
70871950|NCT03789474|141229113|SUPERIORITY|||||||0.746|||||||t-test, 2 sided|||||||.746
70871951|NCT03789474|141229114|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||.006
70871952|NCT03789474|141229115|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||.003
70871953|NCT03789474|141229116|SUPERIORITY|||||||0.043|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.043
70871954|NCT03789474|141229117|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||||||.160
70871955|NCT00843024|141229179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.003|TWO_SIDED|95.0|0.09|0.3||Adjusted for multiplicity according to the fixed sequence testing strategy|Cochran-Mantel-Haenszel||Sumatriptan 10 mg/Naproxen 60 mg minus placebo|||0.30|0.09|0.003
70871956|NCT00843024|141229179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.003|TWO_SIDED|95.0|0.07|0.26||Adjusted for multiplicity according to the fixed-sequence testing strategy|Cochran-Mantel-Haenszel||Sumatriptan 30 mg/Naproxen180 mg minus placebo|||0.26|0.07|0.003
70871957|NCT00843024|141229179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.003|TWO_SIDED|95.0|0.05|0.22||Adjusted for multiplicity according to the fixed-sequence testing strategy|Cochran-Mantel-Haenszel||Sumatriptan 85 mg/Naproxen 500 mg minus placebo|||0.22|0.05|0.003
70871958|NCT00006237|141229213|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||Log Rank|||||||0.49
70871959|NCT00006237|141229214|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Log Rank|||||||0.02
70954210|NCT00688870|141411074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.4|||Chan and Zhang|||Common serotypes - serotype 14||4.4|-4.6|
70954211|NCT00688870|141411074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.4|||Chan and Zhang|||Common serotypes - serotype 18C||4.4|-4.6|
70871960|NCT02837783|141229236|SUPERIORITY|||||||0.283|||||||Wilcoxon rank sum test|||||||0.283
70871961|NCT02216591|141229250|SUPERIORITY|||||||0.013|||||||ANCOVA|Mixed-model general linear model with age and education included as covariates. Time x arm interaction was significant, F(1,16) = 7.76, p = 0.013.||||||.013
70871962|NCT02216591|141229251|SUPERIORITY|||||||0.274|||||||ANCOVA|Mixed-model general linear model with age and education included as covariates. Time x arm interaction was not significant, F(1,16) = 1.29, p = 0.274||||||.274
70871963|NCT02216591|141229252|SUPERIORITY|||||||0.41|||||||ANCOVA|Mixed-model general linear model with age and education included as covariates. Time x arm interaction was not significant, F(1,16) = .72, p = 0.410||||||.410
70871964|NCT02207244|141229253|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||< 0.001
70871965|NCT02207244|141229254|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||< 0.001
70871966|NCT02207244|141229255|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||< 0.001
70871967|NCT02207244|141229256|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||< 0.001
70871968|NCT02207244|141229257|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||< 0.001
70871969|NCT02207244|141229258|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Log Rank|||p value is based on the log-rank test stratified by investigator site (pooled).||||< 0.001
70871970|NCT02207244|141229259|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||p value is based on analysis of variance (ANOVA) model stratified by investigator site (pooled).||||< 0.001
70871971|NCT02207244|141229260|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= -10.0%|Difference in Percentage|16.4|||<|0.001|TWO_SIDED|95.0|10.0|23.2|||MH Z-test|||p value is based on 1-sided Mantel Haenszel (MH) Z-test adjusted for investigator site (pooled).||23.2|10.0|< 0.001
70871972|NCT02207244|141229260|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
70872261|NCT02321800|141229774|NON_INFERIORITY|The margin of noninferiority was 20%. Noninferiority was concluded if the lower bound of a 2-sided 95% CI for the difference in response rates between the 2 treatment groups was greater than -20%. If the noninferiority inference based on the 20% margin was concluded successfully, noninferiority inference based on the 15% margin was performed.|Treatment Difference|18.58|||||TWO_SIDED|95.0|8.23|28.92||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||28.92|8.23|
70872262|NCT02321800|141229775|OTHER||Treatment Difference|0.66|||||TWO_SIDED|95.0|-6.48|7.79||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||7.79|-6.48|
70872263|NCT02321800|141229776|OTHER||Treatment Difference|0.72|||||TWO_SIDED|95.0|-3.48|4.92||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||4.92|-3.48|
70872264|NCT02321800|141229777|OTHER||Treatment Difference|15.31|||||TWO_SIDED|95.0|4.69|25.92||||||||25.92|4.69|
70872265|NCT02321800|141229778|OTHER||Treatment Difference|17.25|||||TWO_SIDED|95.0|6.92|27.58||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||27.58|6.92|
70872266|NCT02321800|141229779|OTHER||Treatment Difference|1.28|||||TWO_SIDED|95.0|-4.83|7.39||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||7.39|-4.83|
70872267|NCT02321800|141229780|OTHER||Treatment Difference|1.1|||||TWO_SIDED|95.0|-3.04|5.25||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||5.25|-3.04|
70872268|NCT02321800|141229781|OTHER||Treatment Difference|13.92|||||TWO_SIDED|95.0|3.21|24.63||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||24.63|3.21|
70872269|NCT02321800|141229786|OTHER||Treatment Difference|2.39|||||TWO_SIDED|95.0|-4.66|9.44||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||9.44|-4.66|
70872270|NCT02321800|141229787|OTHER||Treatment Difference|-0.26|||||TWO_SIDED|95.0|-6.57|6.05||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||6.05|-6.57|
70872271|NCT02321800|141229788|OTHER||Treatment Difference|-1.07|||||TWO_SIDED|95.0|-3.42|1.29||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||1.29|-3.42|
70872272|NCT02321800|141229789|OTHER||Treatment Difference|9.02|||||TWO_SIDED|95.0|-0.37|18.41||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||18.41|-0.37|
70872273|NCT00730132|141229872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||Pearson Chi-Square|||Significance of the differences in the number of patients per group who achieved goal TC levels on Visit 2.||||0.007
70872274|NCT00730132|141229873|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Chi square, continuity corrected. Asymptotic significance.|McNemar|||Significance of paired changes in the number of patients who achieved LDL-C target levels on Visit 2, for each treatment group comparison||||<0.001
70872275|NCT00730132|141229874|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|25.757|STANDARD_DEVIATION|12.30606||||95.0||||||||Descriptive statistics of relative (%) change in TC levels from Baseline at Visit 2||||
70872276|NCT00730132|141229874|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|20.0|STANDARD_DEVIATION|15.662||||95.0||||||||Descriptive statistics of relative (%) change in TC from baseline at Visit 2||||
70872277|NCT00730132|141229874|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|22.8181|STANDARD_DEVIATION|14.03545||||95.0||||||||Descriptive statistics of relative (%) change in TC from baseline at Visit 2||||
70872278|NCT00730132|141229874|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.80928|STANDARD_ERROR_OF_MEAN|1.48621||0.143|TWO_SIDED|95.0|-6.307|0.6884|||Games-Howell|||Statin Dose Titration compared to New Statin||.6884|-6.3070|.143
70872279|NCT00730132|141229874|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.74811|STANDARD_ERROR_OF_MEAN|1.56351||0.001|TWO_SIDED|95.0|-9.4298|-2.0664|||Games-Howell|||Statin Dose Titration compared to Ezetimbe||-2.0664|-9.4298|.001
70872280|NCT00730132|141229874|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.93883|STANDARD_ERROR_OF_MEAN|1.38286||0.086|TWO_SIDED|95.0|-6.1948|0.3171|||Games-Howell|||New Statin compared to Ezetimibe||.3171|-6.1948|.086
70872281|NCT00730132|141229875|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|26.8174|STANDARD_DEVIATION|19.85205||||95.0||||||||Descriptive statistics of relative (%) change in LDL-C levels by the end of the study (Visit 2) compared to Baseline (Visit 1)||||
70872282|NCT00730132|141229875|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|28.2488|STANDARD_DEVIATION|20.78727||||95.0||||||||Descriptive statistics of relative (%) change in LDL-C levels by the end of the study (Visit 2) compared to Baseline (Visit 1)||||
70954456|NCT03691909|141411791|OTHER|||||||0.743|||||||Wilcoxon-signed rank test|Effect Size: 0.09||||||0.743
70954457|NCT03691909|141411792|OTHER|||||||0.714|||||||Wilcoxon-signed rank test|Effect Size: 0.10||||||0.714
70954458|NCT03691909|141411793|OTHER|||||||0.183|||||||Wilcoxon-signed rank test|Effect Size: 0.37||||||0.183
70954459|NCT03691909|141411794|OTHER|||||||0.775|||||||Wilcoxon-signed rank test|Effect Size: 0.05||||||0.775
70954460|NCT03691909|141411795|OTHER|||||||0.0008|||||||Wilcoxon-signed rank test|Effect Size: 0.93||Tender Joint Count||||0.0008
70954461|NCT03691909|141411795|OTHER|||||||0.003|||||||Wilcoxon-signed rank test|Effect Size: 0.83||Swollen Joint Count||||0.003
70954462|NCT05260021|141411831|SUPERIORITY||LS Mean difference (Final Values)|-1.8|||<|0.001|TWO_SIDED|95.0|-2.35|-1.25|||ANCOVA|||||-1.25|-2.35|<0.001
70954463|NCT05260021|141411832|SUPERIORITY||LS Mean difference (Final Values)|-1.67|||<|0.001|TWO_SIDED|95.0|-2.31|-1.02|||ANCOVA|||||-1.02|-2.31|<0.001
70954464|NCT05260021|141411832|SUPERIORITY||LS Mean difference (Final Values)|-1.93|||<|0.001|TWO_SIDED|95.0|-2.57|-1.29|||ANCOVA|||||-1.29|-2.57|<0.001
70954465|NCT05260021|141411833|SUPERIORITY||Risk Difference (RD)|40.1|||<|0.001|TWO_SIDED|95.0|18.6|61.7|||Regression, Logistic|||||61.7|18.6|<0.001
70954466|NCT05260021|141411833|SUPERIORITY||Risk Difference (RD)|51.6|||<|0.001|TWO_SIDED|95.0|31.1|72.2|||Regression, Logistic|||||72.2|31.1|<0.001
70954467|NCT05260021|141411833|SUPERIORITY||Risk Difference (RD)|45.8|||<|0.001|TWO_SIDED|95.0|27.5|64.1|||Regression, Logistic|||||64.1|27.5|<0.001
70954468|NCT05260021|141411834|SUPERIORITY||LS Mean difference (Final Values)|-0.36|||<|0.001|TWO_SIDED|95.0|-0.55|-0.16|||ANCOVA|||||-0.16|-0.55|< 0.001
70954469|NCT05260021|141411834|SUPERIORITY||LS Mean difference (Final Values)|-0.66|||<|0.001|TWO_SIDED|95.0|-0.86|-0.47|||ANCOVA|||||-0.47|-0.86|<0.001
70954470|NCT05260021|141411834|SUPERIORITY||LS Mean difference (Final Values)|-0.51|||<|0.001|TWO_SIDED|95.0|-0.68|-0.34|||ANCOVA|||||-0.34|-0.68|< 0.001
70954471|NCT05260021|141411835|SUPERIORITY||LS Mean difference (Final Values)|-28.9||||0.007|TWO_SIDED|95.0|-49.7|-8.0|||ANCOVA|||||-8.0|-49.7|0.007
70954472|NCT05260021|141411835|SUPERIORITY||LS Mean difference (Final Values)|-44.0|||<|0.001|TWO_SIDED|95.0|-64.3|-23.6|||ANCOVA|||||-23.6|-64.3|< 0.001
70954473|NCT05260021|141411835|SUPERIORITY||LS Mean difference (Final Values)|-36.4|||<|0.001|TWO_SIDED|95.0|-54.2|-18.6|||ANCOVA|||||-18.6|-54.2|< 0.001
70954474|NCT05260021|141411836|SUPERIORITY||LS Mean difference (Final Values)|-6.18|||<|0.001|TWO_SIDED|95.0|-9.31|-3.05|||ANCOVA|||||-3.05|-9.31|< 0.001
70872283|NCT00730132|141229875|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|32.0665|STANDARD_DEVIATION|15.5901||||95.0||||||||Descriptive statistics of relative (%) change in LDL-C levels by the end of the study (Visit 2) compared to Baseline (Visit 1)||||
70872284|NCT00730132|141229875|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.43138|STANDARD_ERROR_OF_MEAN|2.01009||0.756|TWO_SIDED|95.0|-6.1604|3.2977|||Games-Howell|||Statin Dose Titration compared to New Statin||3.2977|-6.1604|.756
70872285|NCT00730132|141229875|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.24911|STANDARD_ERROR_OF_MEAN|1.97821||0.023|TWO_SIDED|95.0|-9.9072|-0.591|||Games-Howell|||Statin Dose Titration compared to Ezetimibe||-.5910|-9.9072|.023
70872286|NCT00730132|141229875|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.81773|STANDARD_ERROR_OF_MEAN|1.88425||0.107|TWO_SIDED|95.0|-8.2523|0.6169|||Games-Howell|||New Statin compared to Ezetimibe||.6169|-8.2523|.107
70872287|NCT00518986|141229887|SUPERIORITY_OR_OTHER|||||||0.3043||95.0|||||ANCOVA|Study drug was fixed factor and corresponding baseline value was a covariate.||Since there were two primary outcome measures the Hochberg procedure was used to control overall Type 1 error rate at the 0.05 level. If both p-values for the primary variables were \<= 0.05 the treatment was claimed to be significant for both variables. If 1 p-value was \> 0.05and the other was \<=0.025, the variable with a p-value \<= 0.025 was claimed as significant.||||0.3043
70872288|NCT00518986|141229888|SUPERIORITY_OR_OTHER|||||||0.012|||||||Chi-squared|P-value for comparison is from a Pearson's chi-square test||Since there were two primary outcome measures the Hochberg procedure was used to control overall Type 1 error rate at the 0.05 level. If both p-values for the primary variables were \<= 0.05 the treatment was claimed to be significant for both variables. If 1 p-value was \> 0.05and the other was \<=0.025, the variable with a p-value \<= 0.025 was claimed as significant.||||0.0120
70872289|NCT00518986|141229889|SUPERIORITY_OR_OTHER|||||||0.0027||||||Nominal p-value is presented, but statistical significance cannot be claimed. As a key secondary variable significance could be claimed only if treatment effect was significant for both primary efficacy variables.|ANCOVA|||Least squares (LS) mean and standard error of the LS mean for each treatment group, and p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline as covariate.||||0.0027
70872290|NCT00518986|141229890|SUPERIORITY_OR_OTHER|||||||0.0019|||||||ANCOVA|||||||0.0019
70872291|NCT00518986|141229891|SUPERIORITY_OR_OTHER|||||||0.3145|||||||ANCOVA|||||||0.3145
70872292|NCT00518986|141229892|SUPERIORITY_OR_OTHER|||||||0.2196|||||||ANCOVA|||||||0.2196
70872293|NCT00518986|141229893|SUPERIORITY_OR_OTHER|||||||0.2017||||||P-value is from Pearson's chi-square test|Chi-squared|||||||0.2017
70872294|NCT00518986|141229894|SUPERIORITY_OR_OTHER|||||||0.0032||||||P-value from Pearson's chi-square test|Chi-squared|||||||0.0032
70872295|NCT00518986|141229895|SUPERIORITY_OR_OTHER|||||||0.0207||||||P-value from Pearson's chi-square test|Chi-squared|||||||0.0207
70872296|NCT00518986|141229896|SUPERIORITY_OR_OTHER|||||||0.0529||||||P-value was generated from a Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel|||||||0.0529
70872297|NCT00518986|141229897|SUPERIORITY_OR_OTHER|||||||0.0011|||||||Cochran-Mantel-Haenszel|||||||0.0011
70954475|NCT05260021|141411836|SUPERIORITY||LS Mean difference (Final Values)|-10.52|||<|0.001|TWO_SIDED|95.0|-13.67|-7.38|||ANCOVA|||||-7.38|-13.67|< 0.001
70954476|NCT05260021|141411836|SUPERIORITY||LS Mean difference (Final Values)|-8.35|||<|0.001|TWO_SIDED|95.0|-11.05|-5.66|||ANCOVA|||||-5.66|-11.05|< 0.001
70954477|NCT05260021|141411837|SUPERIORITY||Risk Difference (RD)|29.5||||0.006|TWO_SIDED|95.0|8.6|50.3|||Regression, Logistic|||||50.3|8.6|0.006
70872298|NCT00518986|141229898|SUPERIORITY_OR_OTHER|||||||0.0064||95.0|||||Cochran-Mantel-Haenszel|||||||0.0064
70872299|NCT00518986|141229899|SUPERIORITY_OR_OTHER|||||||0.1072|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1072
70872300|NCT00518986|141229900|SUPERIORITY_OR_OTHER|||||||0.0355|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0355
70872301|NCT00518986|141229901|SUPERIORITY_OR_OTHER|||||||0.0591|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0591
70872302|NCT00518986|141229902|SUPERIORITY_OR_OTHER|||||||0.0025|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0025
70872303|NCT00518986|141229903|SUPERIORITY_OR_OTHER|||||||0.0794||||||P-value for treatment comparison is from Pearson's chi-square test|Chi-squared|||||||0.0794
70872304|NCT00518986|141229904|SUPERIORITY_OR_OTHER|||||||0.0888||||||P-value for the treatment comparison is from a Pearson's chi-square test|Chi-squared|||||||0.0888
70872305|NCT00518986|141229905|SUPERIORITY_OR_OTHER|||||||0.0433||||||P-value for the treatment comparison is from a Pearson's chi-square test.|Chi-squared|||||||0.0433
70872306|NCT00518986|141229906|SUPERIORITY_OR_OTHER|||||||0.0105||||||P-value for the treatment comparison is from a Pearson's chi-square test.|Chi-squared|||||||0.0105
70872307|NCT00518986|141229907|SUPERIORITY_OR_OTHER|||||||0.0523|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0523
70872308|NCT00518986|141229908|SUPERIORITY_OR_OTHER|||||||0.0289|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0289
70872309|NCT00518986|141229909|SUPERIORITY_OR_OTHER|||||||0.1272|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1272
70872310|NCT00518986|141229910|SUPERIORITY_OR_OTHER|||||||0.0349|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0349
70872311|NCT00518986|141229911|SUPERIORITY_OR_OTHER|||||||0.0094|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0094
70872312|NCT00518986|141229912|SUPERIORITY_OR_OTHER|||||||0.0754|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0754
70872313|NCT00518986|141229913|SUPERIORITY_OR_OTHER|||||||0.0105|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0105
70872314|NCT00518986|141229914|SUPERIORITY_OR_OTHER|||||||0.2888|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2888
70872315|NCT00518986|141229915|SUPERIORITY_OR_OTHER|||||||0.013|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0130
70872316|NCT00518986|141229916|SUPERIORITY_OR_OTHER|||||||0.0354|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0354
70872317|NCT00518986|141229917|SUPERIORITY_OR_OTHER|||||||0.3854||||||P-value for the treatment comparison is from a Pearson's chi-square test|Chi-squared|||Responders are subjects with worst fatigue score \< 7 after baseline||||0.3854
70872318|NCT00518986|141229918|SUPERIORITY_OR_OTHER|||||||0.0145||||||P-value for the treatment comparison is from Pearson's chi-square test|Chi-squared|||Responders were defined as subjects with worst fatigue score \< 7||||0.0145
70872319|NCT00518986|141229919|SUPERIORITY_OR_OTHER|||||||0.6475||||||P-value for the treatment comparison is from a Pearson's chi-square test|Chi-squared|||Responders were patients with worst fatigue scores \< 7||||0.6475
70872320|NCT00518986|141229920|SUPERIORITY_OR_OTHER|||||||0.0118||||||P-value for the treatment comparison is from Pearson's chi-square test|Chi-squared|||Responders are subjects with worst fatigue score \< 7||||0.0118
70872321|NCT00518986|141229921|SUPERIORITY_OR_OTHER|||||||0.3483||||||P-value for the treatment comparison is from the Pearson's chi-square test.|Chi-squared|||Responders are subjects with a worst fatigue score of \< 7||||0.3483
70872322|NCT00518986|141229922|SUPERIORITY_OR_OTHER|||||||0.0879|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0879
70872323|NCT00518986|141229923|SUPERIORITY_OR_OTHER|||||||0.0277|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0277
70872324|NCT00518986|141229924|SUPERIORITY_OR_OTHER|||||||0.1245|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1245
70872325|NCT00518986|141229925|SUPERIORITY_OR_OTHER|||||||0.0305|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0305
70872326|NCT00518986|141229926|SUPERIORITY_OR_OTHER|||||||0.0129|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0129
70872327|NCT00518986|141229927|SUPERIORITY_OR_OTHER|||||||0.0308||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0308
70872328|NCT00518986|141229928|SUPERIORITY_OR_OTHER|||||||0.0679|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0679
70872329|NCT00518986|141229929|SUPERIORITY_OR_OTHER|||||||0.0153|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0153
70872330|NCT00518986|141229930|SUPERIORITY_OR_OTHER|||||||0.0296|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0296
70872331|NCT00518986|141229931|SUPERIORITY_OR_OTHER|||||||0.0107|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0107
70872332|NCT00518986|141229932|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value for the treatment comparison is from a Pearson's chi-square test|Chi-squared|||Responders are defined as patients with a total score on FOSQ \> 17.9||||0.0100
70872333|NCT00518986|141229933|SUPERIORITY_OR_OTHER|||||||0.0854||95.0||||P-value for treatment comparison is from a Pearson's chi-square test|Chi-squared|||Responders are defined as subjects with a total score of \> 17.9||||0.0854
70872334|NCT00518986|141229934|SUPERIORITY_OR_OTHER|||||||0.0027||95.0||||P-value for the treatment comparison is from Pearson's chi-square test|Chi-squared|||Responders are defined as subjects with a total score \> 17.9||||0.0027
70872335|NCT00518986|141229935|SUPERIORITY_OR_OTHER|||||||0.0189||95.0||||P-value for the treatment comparison is from a Pearson's chi-square test.|Chi-squared|||Responders are defined as subjects who had a total score of \> 17.9||||0.0189
70872336|NCT00518986|141229936|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||P-value for the treatment comparison is from a Pearson's chi-square test|Chi-squared|||Responders are defined as subjects with total score \> 17.9||||0.0240
70872337|NCT00518986|141229937|SUPERIORITY_OR_OTHER|||||||0.332||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3320
70872338|NCT00518986|141229938|SUPERIORITY_OR_OTHER|||||||0.893||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8930
70872339|NCT00518986|141229939|SUPERIORITY_OR_OTHER|||||||0.1774||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1774
70872340|NCT00518986|141229940|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1000
70872341|NCT00518986|141229941|SUPERIORITY_OR_OTHER|||||||0.2428||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2428
70872342|NCT00518986|141229942|SUPERIORITY_OR_OTHER|||||||0.1816||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1816
70872343|NCT00518986|141229943|SUPERIORITY_OR_OTHER|||||||0.1627||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1627
70872344|NCT00518986|141229944|SUPERIORITY_OR_OTHER|||||||0.0018||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0018
70872345|NCT00518986|141229945|SUPERIORITY_OR_OTHER|||||||0.0096||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0096
70872346|NCT00518986|141229946|SUPERIORITY_OR_OTHER|||||||0.0126||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0126
70872347|NCT03366337|141230012|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 12.|LS Mean change from baseline|9.31|STANDARD_ERROR_OF_MEAN|1.3743|<|0.0001|TWO_SIDED|95.0|6.5|12.13|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 12 were included. Missing data were not imputed.||||12.13|6.5|<0.0001
70872348|NCT03366337|141230012|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 12.|LS Mean change from baseline|8.0|STANDARD_ERROR_OF_MEAN|1.57|<|0.0001|TWO_SIDED|95.0|4.75|11.25|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 12 were included. Missing data were not imputed.||||11.25|4.75|<0.0001
70872349|NCT03366337|141230012|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 12.|LS Mean change from baseline|5.46|STANDARD_ERROR_OF_MEAN|2.2792||0.0247|TWO_SIDED|95.0|0.76|10.16|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 12 were included. Missing data were not imputed.||||10.16|0.76|0.0247
70954478|NCT05260021|141411837|SUPERIORITY||Risk Difference (RD)|39.5|||<|0.001|TWO_SIDED|95.0|18.8|60.2|||Regression, Logistic|||||60.2|18.8|< 0.001
70954479|NCT05260021|141411837|SUPERIORITY||Risk Difference (RD)|34.6|||<|0.001|TWO_SIDED|95.0|17.0|52.1|||Regression, Logistic|||||52.1|17|< 0.001
70872350|NCT03366337|141230012|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 12.|LS Mean change from baseline|7.83|STANDARD_ERROR_OF_MEAN|2.216||0.003|TWO_SIDED|95.0|3.11|12.55|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 12 were included. Missing data were not imputed.||||12.55|3.11|0.0030
70872351|NCT05231954|141230108|SUPERIORITY||Odds Ratio (OR)|1.29||||0.006|TWO_SIDED|95.0|1.08|1.55||P-value is adjusted for multiple comparisons, and a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||1.55|1.08|0.006
70872352|NCT05231954|141230108|SUPERIORITY||Odds Ratio (OR)|0.82||||0.081|TWO_SIDED|95.0|0.65|1.03||The p-value is adjusted for multiple comparisons, and a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||1.03|0.65|0.081
70872353|NCT05231954|141230109|SUPERIORITY||Odds Ratio (OR)|1.44||||0.044|TWO_SIDED|95.0|1.01|2.05||The p-value is adjusted for multiple comparisons, and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||2.05|1.01|0.044
70872354|NCT05231954|141230109|SUPERIORITY||Odds Ratio (OR)|1.02||||0.919|TWO_SIDED|95.0|0.69|1.5||The p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||1.50|0.69|0.919
70872355|NCT00540514|141230144|SUPERIORITY_OR_OTHER_LEGACY||Response Rate Ratio|1.313||||0.005|TWO_SIDED|95.1|1.082|1.593||Statistical significance defined as P-value \< 0.049.|Chi-squared||Response rate ratio = PA/PT. A response rate ratio \> 1 favors the albumin-bound paclitaxel/carboplatin arm of the study.|The null hypothesis is that the albumin-bound paclitaxel/carboplatin regimen response rate (PA) is equal to that of the paclitaxel (Taxol)/carboplatin regimen (PT). Superiority of albumin-bound paclitaxel/carboplatin to paclitaxel/carboplatin will be established if the lower bound of the 95.1% CI of the response rate ratio is \> 1.0.||1.593|1.082|0.005
70872356|NCT00540514|141230145|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.902||||0.214|TWO_SIDED|95.1|0.767|1.06||P-value is based on a stratified log rank test stratified by geographic region (North America/Australia, Eastern Europe, or Asia/Pacific) and histology of primary diagnosis (squamous cell carcinoma, adenocarcinoma, or other carcinoma).|Log Rank||Hazard ratio (albumin-bound paclitaxel/carboplatin to paclitaxel/carboplatin) \<1 favors the albumin-bound paclitaxel/carboplatin group.|||1.060|0.767|0.214
70954480|NCT05260021|141411838|SUPERIORITY||Risk Difference (RD)|43.4|||<|0.001|TWO_SIDED|95.0|22.3|64.4|||Regression, Logistic|||||64.4|22.3|< 0.001
70872357|NCT00540514|141230146|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.922||||0.271|TWO_SIDED|95.1|0.797|1.066||P-value is based on a stratified log rank test stratified by geographic region (North America/Australia, Eastern Europe, or Asia/Pacific) and histology of primary diagnosis (Squamous cell carcinoma, adenocarcinoma, or other carcinoma).|Log Rank||Hazard ratio (albumin-bound paclitaxel/carboplatin to paclitaxel/carboplatin) \<1 favors the albumin-bound paclitaxel/carboplatin group.|||1.066|0.797|0.271
70872358|NCT00540514|141230147|SUPERIORITY_OR_OTHER_LEGACY||Response Rate Ratio|1.074||||0.239|TWO_SIDED|95.0|0.953|1.21|||Chi-squared|||||1.210|0.953|0.239
70872359|NCT00540514|141230148|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.901||||0.551|TWO_SIDED|95.0|0.652|1.244||P-value is based on a stratified log rank test stratified by geographic region (North America/Australia, Eastern Europe, or Asia/Pacific) and histology of primary diagnosis (Squamous cell carcinoma or Non squamous cell carcinoma).|Log Rank||Hazard ratio (albumin-bound paclitaxel/carboplatin to paclitaxel/carboplatin) \<1 favors the albumin-bound paclitaxel/carboplatin group.|||1.244|0.652|0.551
70872360|NCT00540514|141230151|SUPERIORITY_OR_OTHER_LEGACY|||||||0.302||95.0|||||Univariate Cox regression|||SPARC correlation with overall survival for the overall SPARC population.||||0.302
70872361|NCT00540514|141230152|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036||95.0||||A nonsignificant interaction P-value (ie, p-value ≥ 0.100) indicates the treatment regimen effect was consistent within a prognostic factor.|Regression, Logistic|Logistic regression model with effects for treatment regimen, prognostic factor (histology), and treatment regimen by prognostic factor interaction.||||||0.036
70872362|NCT02324569|141230169|SUPERIORITY||Least square (LS) mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.097|<|0.0001|TWO_SIDED|95.0|-0.826|-0.443|||ANCOVA|||||-0.443|-0.826|<0.0001
70872363|NCT00911820|141230180|SUPERIORITY|||||||0.714|||||||Log Rank|||||||0.714
70872364|NCT00911820|141230182|SUPERIORITY|||||||0.605|||||||Fisher Exact|||||||0.605
70872365|NCT00911820|141230183|SUPERIORITY|||||||0.721|||||||Log Rank|||||||0.721
70872366|NCT01411774|141230264|SUPERIORITY|||||||0.95||||||p \< .05 was the threshold of significance.|Mixed Models Analysis|Analysis for the outcomes used linear mixed-effects models, with treatment group as the between-participant factor and time as the within group factor||||||.95
70872367|NCT00056316|141230267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.93||||0.05||95.0|||||t-test, 2 sided||Mean difference is equal to Behavioral Skills Intervention minus Basic Education Control|||||.05
70872368|NCT00056316|141230268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.07||||0.05||95.0|||||t-test, 2 sided||Mean difference is equal to Behavioral Skills Intervention minus Basic Education Control|||||.05
70954481|NCT05260021|141411838|SUPERIORITY||Risk Difference (RD)|47.1|||<|0.001|TWO_SIDED|95.0|26.4|67.7|||Regression, Logistic|||||67.7|26.4|< 0.001
70954482|NCT05260021|141411838|SUPERIORITY||Risk Difference (RD)|45.2|||<|0.001|TWO_SIDED|95.0|26.3|64.1|||Regression, Logistic|||||64.1|26.3|< 0.001
70872369|NCT02990910|141230273|SUPERIORITY||||||<|0.05|||||||Chi-squared|||Chi square test was used to compare the count data,p \< 0.05 was considered statistically significant.||||<0.05
70872370|NCT00583778|141230277|SUPERIORITY||Median Difference (Final Values)|12.0|STANDARD_DEVIATION|25.0|<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Data were analyzed using STATA 10 SE.Categorical variables were described using frequencies and relative frequencies. Distribution of continuous variables were evaluated for normality using the Shapiro-Walk test and graphically using histograms and box plots. Because most data were non-parametric, they were described using the median and 25th and 75th percentiles (interquartile range) and then compared using Wilcoxon rank sum test.|This study was designed to detect an absolute difference of 12 % in change of FEV-1percent predicted, with a standard deviation of 25% based on data provided to us from previous studies conducted by Sepracor. Based on this assumption, we sought to enter 76 patients in each group to have an 80% power to detect a 12 % absolute difference in charge of FEV-1 percent predicted over time at an alpha of 0.05. This accounted for a potential 10% dropout rate after randomization.|||< 0.05
70872371|NCT00903695|141230280|SUPERIORITY_OR_OTHER|||||||0.8133||||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA calculation: F-ratio = 0.06, t-test = -0.25."||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.8133
70872372|NCT00903695|141230281|SUPERIORITY_OR_OTHER|||||||0.31||||||a priori threshold for statistical sginficance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA calculation: F-ratio=1.22, t-test=1.1"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.31
70872373|NCT00903695|141230282|SUPERIORITY_OR_OTHER|||||||0.27||||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA: F-ratio = 1.5, t-test = -1.23"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.27
70872374|NCT00903695|141230283|SUPERIORITY_OR_OTHER|||||||0.24||||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA: F-ratio = 1.7, t-test = 1.3"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.24
70872375|NCT00903695|141230284|SUPERIORITY_OR_OTHER|||||||0.71||95.0||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA: F-ratio = 0.15, t-test = 0.39"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.71
70872376|NCT00903695|141230285|SUPERIORITY_OR_OTHER|||||||0.18||||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA: F-ratio = 2.25, ttest = -1.5"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.18
70872377|NCT00903695|141230286|SUPERIORITY_OR_OTHER|||||||0.34||||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA: F-ratio = 1.06, t-test = -1.03"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.34
70872378|NCT00543140|141230315|SUPERIORITY_OR_OTHER|||||||0.6919|TWO_SIDED|||||No adjustments for multiple comparisons were performed as only one hypothesis was tested in this study. The level of significance was set at 0.05.|Exact Binomial method|||The primary analysis used a one-sided binomial exact test method by Clopper and Pearson to determine if the rate of reoperations observed in Years 4 and 5 (combined) of the study was significantly less than 8%. The null hypothesis was that the reoperation rate was greater than or equal to 8%.||||0.6919
70872379|NCT01603056|141230326|SUPERIORITY_OR_OTHER|||||||0.743|TWO_SIDED||||||t-test, 2 sided|||||||0.743
70872380|NCT01603056|141230327|SUPERIORITY_OR_OTHER|||||||0.627|TWO_SIDED||||||t-test, 2 sided|||||||0.627
70872381|NCT01603056|141230328|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||t-test, 2 sided|||||||0.74
70872382|NCT01603056|141230329|SUPERIORITY_OR_OTHER|||||||0.641|TWO_SIDED||||||t-test, 2 sided|||||||0.641
70872383|NCT01603056|141230330|SUPERIORITY_OR_OTHER|||||||0.818|TWO_SIDED||||||t-test, 2 sided|||||||0.818
70872384|NCT01603056|141230331|SUPERIORITY_OR_OTHER|||||||0.391|TWO_SIDED||||||t-test, 2 sided|||||||0.391
70872385|NCT01603056|141230332|SUPERIORITY_OR_OTHER|||||||0.497|TWO_SIDED||||||t-test, 2 sided|||||||0.497
70872386|NCT01603056|141230333|SUPERIORITY_OR_OTHER|||||||0.222|TWO_SIDED||||||t-test, 2 sided|||||||0.222
70872387|NCT01603056|141230334|SUPERIORITY_OR_OTHER|||||||0.438|TWO_SIDED||||||Fisher Exact|||||||0.438
70872388|NCT01603056|141230335|SUPERIORITY_OR_OTHER|||||||0.465|TWO_SIDED||||||t-test, 2 sided|||||||0.465
70872389|NCT01603056|141230336|SUPERIORITY_OR_OTHER|||||||0.123|TWO_SIDED||||||t-test, 2 sided|||||||0.123
70872390|NCT01603056|141230337|SUPERIORITY_OR_OTHER|||||||0.719|TWO_SIDED||||||t-test, 2 sided|||||||0.719
70872391|NCT00420927|141230360|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||Chi-squared|P value is from Pearson's chi-square test.||||||0.023
70954483|NCT05260021|141411840|SUPERIORITY||LS Mean difference (Final Values)|0.014||||0.708|TWO_SIDED|95.0|-0.061|0.089|||Mixed Models Analysis|||||0.089|-0.061|0.708
70954484|NCT05260021|141411840|SUPERIORITY||LS Mean difference (Final Values)|-0.001||||0.976|TWO_SIDED|95.0|-0.076|0.074|||Mixed Models Analysis|||||0.074|-0.076|0.976
70872392|NCT00420927|141230361|SUPERIORITY_OR_OTHER|||||||0.082||95.0|||||Regression, Logistic|||||||0.082
70872393|NCT00420927|141230362|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||Regression, Logistic|||||||0.280
70872394|NCT00420927|141230362|SUPERIORITY_OR_OTHER|||||||0.287||95.0|||||Regression, Logistic|||||||0.287
70872395|NCT00420927|141230363|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Regression, Logistic|||||||0.026
70872396|NCT00420927|141230363|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Regression, Logistic|||||||0.009
70872397|NCT00420927|141230364|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Regression, Logistic|||||||0.060
70872398|NCT00420927|141230364|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||Regression, Logistic|||||||0.063
70872399|NCT00420927|141230365|SUPERIORITY_OR_OTHER|||||||0.395||95.0|||||Regression, Logistic|||||||0.395
70872400|NCT00420927|141230365|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||Regression, Logistic|||||||0.640
70872401|NCT00420927|141230366|SUPERIORITY_OR_OTHER|||||||0.159||95.0|||||Regression, Logistic|||||||0.159
70872402|NCT00420927|141230366|SUPERIORITY_OR_OTHER|||||||0.217||95.0|||||Regression, Logistic|||||||0.217
70872403|NCT00420927|141230367|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Regression, Logistic|||||||0.060
70872404|NCT00420927|141230367|SUPERIORITY_OR_OTHER|||||||0.043||95.0|||||Regression, Logistic|||||||0.043
70872405|NCT00420927|141230368|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.004
70872406|NCT00420927|141230368|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.049
70872407|NCT00420927|141230369|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Regression, Logistic|||||||0.240
70872408|NCT00420927|141230369|SUPERIORITY_OR_OTHER|||||||0.271||95.0|||||Regression, Logistic|||||||0.271
70872409|NCT00420927|141230370|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Regression, Logistic|||||||0.230
70872410|NCT00420927|141230370|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Regression, Logistic|||||||0.550
70872411|NCT00420927|141230371|SUPERIORITY_OR_OTHER|||||||0.301||95.0|||||Regression, Logistic|||||||0.301
70872412|NCT00420927|141230371|SUPERIORITY_OR_OTHER|||||||0.188||95.0|||||Regression, Logistic|||||||0.188
70872413|NCT00420927|141230372|SUPERIORITY_OR_OTHER|||||||0.314||95.0|||||Regression, Logistic|||||||0.314
70872414|NCT00420927|141230372|SUPERIORITY_OR_OTHER|||||||0.235||95.0|||||Regression, Logistic|||||||0.235
70872415|NCT00420927|141230373|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.030
70872416|NCT00420927|141230373|SUPERIORITY_OR_OTHER|||||||0.403||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.403
70872417|NCT00420927|141230374|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.036
70872418|NCT00420927|141230374|SUPERIORITY_OR_OTHER|||||||0.349||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.349
70872419|NCT00420927|141230375|SUPERIORITY_OR_OTHER|||||||0.037||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.037
70872420|NCT00420927|141230375|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||<0.001
70872421|NCT00420927|141230376|SUPERIORITY_OR_OTHER|||||||0.192||95.0|||||Regression, Logistic|||||||0.192
70872422|NCT00420927|141230376|SUPERIORITY_OR_OTHER|||||||0.241||95.0|||||Regression, Logistic|||||||0.241
70872423|NCT00420927|141230377|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Regression, Logistic|||||||0.028
70872424|NCT00420927|141230377|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Regression, Logistic|||||||0.014
70872425|NCT00420927|141230378|SUPERIORITY_OR_OTHER|||||||0.074||95.0|||||Regression, Logistic|||||||0.074
70872426|NCT00420927|141230378|SUPERIORITY_OR_OTHER|||||||0.077||95.0|||||Regression, Logistic|||||||0.077
70872427|NCT01115101|141230379|NON_INFERIORITY_OR_EQUIVALENCE|VAS score at 24h were defined as primary endpoint because of the expectation of the maximal effect at this time. Testing for differences of continuous variables between the study groups at baseline was accomplished by the 2-sample t test for independent samples or the Mann-Whitney U test, as appropriate.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.05|<|0.05||95.0|||||Chi-squared|Test selection was based on evaluating the variables for normal distribution employing the Kolmogorov-Smirnov test.||"The sample size of n=120 was computed to detect a difference in VAS score at 24h of 1.2 (30% reduction) at a power of 80%, a two-sided significance level of 0.05.~Because measurements were made several times on the same patients within in two independent groups, GLM Repeated Measurement procedure was applied to test null hypotheses about the effects of both the between-subject factor (study group) and the within-subject factor (time)."||||<0.05
70872428|NCT02454296|141230386|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
70872429|NCT02454296|141230387|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
70872430|NCT02454296|141230388|SUPERIORITY_OR_OTHER|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||||||0.34
70872431|NCT01370356|141230389|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.74|||<|0.0001|TWO_SIDED|95.0|6.09|12.53||Statistical test was 2-sided and a 0.05 level of significance was used. A fixed-sequence procedure was used to adjust for multiplicity. Hierarchy of comparisons: 1) 10-week CA for Weeks 15 - 24, 2) CA for Weeks 21 - 24, 3) CA for Weeks 21 - 52.|Regression, Logistic|||Assuming true CA rate of 6.9% for placebo and 17.2% for varenicline (odds ratio ≥ 2.8), a study randomizing 1404 participants (1:1 ratio) has ≥90% power to detect a difference between the two groups. Analysis was done using a logistic regression model; treatment effect as explanatory variable and investigative center as covariate. The interaction effect was tested using an expanded logistic regression model including treatment-by-center interaction.||12.53|6.09|<0.0001
70872432|NCT01370356|141230390|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.66|||<|0.0001|TWO_SIDED|95.0|4.21|7.61||Statistical test was 2-sided and a 0.05 level of significance was used. A fixed-sequence procedure was used to adjust for multiplicity. Hierarchy of comparisons: 1) 10-week CA for Weeks 15 - 24, 2) CA for Weeks 21 - 24, 3) CA for Weeks 21 - 52.|Regression, Logistic|||Analysis was done using a logistic regression model including treatment effect as the explanatory variable and investigative center as covariate. In addition, the interaction effect was tested using an expanded logistic regression model including the treatment-by-center interaction. However, the inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of the treatment by center interaction.||7.61|4.21|<0.0001
70872433|NCT01370356|141230391|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.02|||<|0.0001|TWO_SIDED|95.0|2.94|5.5||Statistical test was 2-sided and a 0.05 level of significance was used. A fixed-sequence procedure was used to adjust for multiplicity. Hierarchy of comparisons: 1) 10-week CA for Weeks 15 - 24, 2) CA for Weeks 21 - 24, 3) CA for Weeks 21 - 52.|Regression, Logistic|||Analysis was done using a logistic regression model including treatment effect as the explanatory variable and investigative center as covariate. In addition, the interaction effect was tested using an expanded logistic regression model including the treatment-by-center interaction. However, the inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of the treatment by center interaction.||5.50|2.94|<0.0001
70872434|NCT01370356|141230392|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.69|||<|0.0001|TWO_SIDED|95.0|6.03|12.51||Statistical test was 2-sided and a 0.05 level of significance was used.|Regression, Logistic|||Statistical analysis presented above is for Week 12. Analysis was done using logistic regression model with treatment effect as the explanatory variable and investigative center as covariate. The interaction effect was tested using an expanded logistic regression model with treatment-by-center interaction. The inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of treatment by center interaction.||12.51|6.03|<0.0001
70872435|NCT01370356|141230392|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.58|||<|0.0001|TWO_SIDED|95.0|3.51|5.98||Statistical test was 2-sided and a 0.05 level of significance was used.|Regression, Logistic|||Statistical analysis presented above is for Week 24. Analysis was done using logistic regression model with treatment effect as the explanatory variable and investigative center as covariate. The interaction effect was tested using an expanded logistic regression model with treatment-by-center interaction. The inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of treatment by center interaction.||5.98|3.51|<0.0001
70872436|NCT01370356|141230392|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.66|||<|0.0001|TWO_SIDED|95.0|2.05|3.44||Statistical test was 2-sided and a 0.05 level of significance was used.|Regression, Logistic|||Statistical analysis presented above is for Week 52. Analysis was done using logistic regression model with treatment effect as the explanatory variable and investigative center as covariate. The interaction effect was tested using an expanded logistic regression model with treatment-by-center interaction. The inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of treatment by center interaction.||3.44|2.05|<0.0001
70872437|NCT01370356|141230393|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.67|||<|0.0001|TWO_SIDED|95.0|2.05|3.47||Statistical test was 2-sided and a 0.05 level of significance was used.|Regression, Logistic|||Analysis was done using a logistic regression model including treatment effect as the explanatory variable and investigative center as covariate. In addition, the interaction effect was tested using an expanded logistic regression model including the treatment-by-center interaction. However, the inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of the treatment by center interaction.||3.47|2.05|<0.0001
70872438|NCT01218243|141230447|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.51|STANDARD_ERROR_OF_MEAN|0.93|<|0.01|TWO_SIDED|95.0|2.67|6.36|||ANCOVA|||||6.36|2.67|< 0.01
70872439|NCT01218243|141230448|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.34|STANDARD_ERROR_OF_MEAN|6.6|>|0.05|TWO_SIDED|95.0|-9.76|16.44|||Wilcoxon (Mann-Whitney)|||||16.44|-9.76|>0.05
70872440|NCT01218243|141230449|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.184|STANDARD_ERROR_OF_MEAN|0.8|>|0.05|TWO_SIDED|95.0|-1.41|1.78|||ANCOVA|||||1.78|-1.41|> 0.05
70872441|NCT01218243|141230450|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.2|STANDARD_ERROR_OF_MEAN|0.93|<|0.01|TWO_SIDED|95.0|1.36|5.05|||ANCOVA|||||5.05|1.36|< 0.01
70872442|NCT01218243|141230451|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.12|STANDARD_ERROR_OF_MEAN|1.03|<|0.01|TWO_SIDED|95.0|2.07|6.18|||ANCOVA|||||6.18|2.07|<0.01
70872443|NCT02615145|141230460|SUPERIORITY|||||||0.111||||||Between group change comparison: overall. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 12||||0.1110
70872444|NCT02615145|141230460|SUPERIORITY||difference in LS means|1.64||||0.2704|TWO_SIDED|95.0|-1.28|4.56||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 12||4.56|-1.28|0.2704
70872445|NCT02615145|141230460|SUPERIORITY||difference in LS means|-0.09||||0.9516|TWO_SIDED|95.0|-3.17|2.98||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 12||2.98|-3.17|0.9516
70872446|NCT02615145|141230460|SUPERIORITY||difference in LS means|-1.73||||0.0489|TWO_SIDED|95.0|-3.46|-0.01||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 12||-0.01|-3.46|0.0489
70872447|NCT02615145|141230460|SUPERIORITY|||||||0.9785||||||Between group change comparison: overall. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 48||||0.9785
70872448|NCT02615145|141230460|SUPERIORITY||difference in LS means|-0.13||||0.9379|TWO_SIDED|95.0|-3.37|3.11||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 48||3.11|-3.37|0.9379
70872449|NCT02615145|141230460|SUPERIORITY||difference in LS means|0.07||||0.9678|TWO_SIDED|95.0|-3.33|3.47||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 48||3.47|-3.33|0.9678
70872450|NCT02615145|141230460|SUPERIORITY||difference in LS means|0.2||||0.8373|TWO_SIDED|95.0|-1.7|2.1||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 48||2.10|-1.70|0.8373
70872451|NCT02615145|141230460|SUPERIORITY||Mean Difference (Final Values)|6.37|||<|0.0001|TWO_SIDED|95.0|5.417|7.32|||paired t-test|paired t-test of whether difference in means is 0||Week 12 vs Baseline across all participants||7.320|5.417|< 0.0001
70872452|NCT02615145|141230460|SUPERIORITY||Mean Difference (Final Values)|10.15|||<|0.0001|TWO_SIDED|95.0|8.936|11.362|||paired t-test|paired t-test of whether difference in means is 0||Week 48 vs Baseline across all participants||11.362|8.936|< 0.0001
70872453|NCT02615145|141230465|SUPERIORITY|||||||0.5751||||||Between group change comparison: overall. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||EOT||||0.5751
70872454|NCT02615145|141230465|SUPERIORITY||difference in LS means|2.29||||0.5176|TWO_SIDED|95.0|-4.66|9.23||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||EoT||9.23|-4.66|0.5176
70872455|NCT02615145|141230465|SUPERIORITY||difference in LS means|0.324||||0.9308|TWO_SIDED|95.0|-7.0|7.64||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||EoT||7.64|-7.00|0.9308
70872456|NCT02615145|141230465|SUPERIORITY||difference in LS means|-1.96||||0.3462|TWO_SIDED|95.0|-6.06|2.13||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||EoT||2.13|-6.06|0.3462
70872457|NCT02615145|141230465|SUPERIORITY|||||||0.7016||||||Between group change comparison: overall. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||12 Weeks after EoT||||0.7016
70872458|NCT02615145|141230465|SUPERIORITY||difference in LS means|-2.61||||0.4002|TWO_SIDED|95.0|-8.71|3.49||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||12 weeks after EoT||3.49|-8.71|0.4002
70954485|NCT05260021|141411840|SUPERIORITY||LS Mean difference (Final Values)|0.007||||0.841|TWO_SIDED|95.0|-0.058|0.071|||Mixed Models Analysis|||||0.071|-0.058|0.841
70872459|NCT02615145|141230465|SUPERIORITY||difference in LS means|-2.33||||0.475|TWO_SIDED|95.0|-8.74|4.08||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||12 weeks after EoT||4.08|-8.74|0.4750
70872460|NCT02615145|141230465|SUPERIORITY||difference in LS means|0.282||||0.874|TWO_SIDED|95.0|-3.21|3.77||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||12 weeks after EoT||3.77|-3.21|0.8740
70872461|NCT02615145|141230465|SUPERIORITY|||||||0.7211||||||Between group change comparison: overall. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||48 weeks after EoT||||0.7211
70872462|NCT02615145|141230465|SUPERIORITY||difference in LS means|-3.67||||0.4256|TWO_SIDED|95.0|-12.7|5.39||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||48 weeks after EoT||5.39|-12.7|0.4256
70872463|NCT02615145|141230465|SUPERIORITY||difference in LS means|-3.01||||0.5347|TWO_SIDED|95.0|-12.6|6.54||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||48 weeks after EoT||6.54|-12.6|0.5347
70872464|NCT02615145|141230465|SUPERIORITY||difference in LS means|0.654||||0.792|TWO_SIDED|95.0|-4.23|5.54||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||48 weeks after EoT||5.54|-4.23|0.7920
70872465|NCT02615145|141230465|SUPERIORITY||Mean Difference (Final Values)|5.64|||<|0.0001|TWO_SIDED|95.0|3.355|7.935|||paired t-test|paired t-test of mean difference from 0||Baseline to EOT across all participants||7.935|3.355|< 0.0001
70872466|NCT02615145|141230465|SUPERIORITY||Mean Difference (Final Values)|10.21|||<|0.0001|TWO_SIDED|95.0|8.113|12.299|||paired t-test|paired t-test of mean difference versus 0||Baseline vs 12 weeks after EOT across all participants||12.299|8.113|< 0.0001
70872467|NCT02615145|141230465|SUPERIORITY||Mean Difference (Final Values)|10.13|||<|0.0001|TWO_SIDED|95.0|7.259|12.992|||paired t-test|paired t-test of mean difference versus 0||baseline vs 48 weeks after EOT across all participants||12.992|7.259|< 0.0001
70872468|NCT02615145|141230466|SUPERIORITY|||||||0.3869||||||Between group change comparison: overall. The dependent variable in the change of PAM-13 from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||||||0.3869
70872469|NCT02615145|141230466|SUPERIORITY||difference in LS means|-1.89||||0.3125|TWO_SIDED|95.0|-5.57|1.79||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable in the change of PAM-13 from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||||1.79|-5.57|0.3125
70872470|NCT02615145|141230466|SUPERIORITY||difference in LS means|-2.65||||0.1741|TWO_SIDED|95.0|-6.48|1.18||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable in the change of PAM-13 from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||||1.18|-6.48|0.1741
70872471|NCT02615145|141230466|SUPERIORITY||difference in LS means|-0.76||||0.4941|TWO_SIDED|95.0|-2.94|1.42||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable in the change of PAM-13 from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||||1.42|-2.94|0.4941
70872472|NCT02615145|141230466|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.8842|TWO_SIDED|95.0|-1.271|1.096|||paired t-test|paired t-test of mean difference vs 0||Change from Baseline to Final visit across all participants||1.096|-1.271|0.8842
70954486|NCT05260021|141411841|SUPERIORITY||LS Mean difference (Final Values)|-0.29|||<|0.001|TWO_SIDED|95.0|-0.45|-0.12|||Mixed Models Analysis|||||-0.12|-0.45|< 0.001
70954487|NCT05260021|141411841|SUPERIORITY||LS Mean difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.57|-0.24|||Mixed Models Analysis|||||-0.24|-0.57|< 0.001
70954488|NCT05260021|141411841|SUPERIORITY||LS Mean difference (Final Values)|-0.34|||<|0.001|TWO_SIDED|95.0|-0.49|-0.2|||Mixed Models Analysis|||||-0.2|-0.49|< 0.001
70872473|NCT03727347|141230470|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Hypothesis was that the improvement (decrease) in rTNSS mean score, from baseline to 12 weeks, would exceed 1 point||||||<0.0001
70872474|NCT03200860|141230476|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||||||0.18
70872475|NCT03200860|141230477|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||||||0.37
70872476|NCT03200860|141230478|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||||||0.58
70872477|NCT03200860|141230479|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||||||0.63
70872478|NCT03200860|141230480|SUPERIORITY|||||||0.31|||||||Regression, Logistic|||||||0.31
70872479|NCT03200860|141230481|SUPERIORITY|||||||0.014|||||||Regression, Logistic|||||||0.014
70872480|NCT02970422|141230495|OTHER|||||||0.91|||||||Chi-squared|Chi-squared value= .57||Relief of breathlessness||||.91
70872481|NCT02970422|141230495|OTHER|||||||0.31|||||||Chi-squared|Chi-squared value= 3.56||Improve your ability to perform activities in and out of your home||||.31
70872482|NCT02970422|141230495|OTHER|||||||0.96|||||||Chi-squared|Chi-squared value=.32||Prevent lung flare-ups||||.96
70872483|NCT02970422|141230495|OTHER|||||||0.04|||||||Chi-squared|Chi-squared value= 8.09||Discuss COPD and its progression||||.04
70872484|NCT02970422|141230495|OTHER|||||||0.7|||||||Chi-squared|Chi-squared value: 1.41||Improve your physical well-being||||.70
70872485|NCT02970422|141230495|OTHER|||||||0.01|||||||Chi-squared|Chi-squared value= 10.81||Relief of breathlessness||||.01
70872486|NCT02970422|141230495|OTHER|||||||0.49|||||||Chi-squared|Chi-squared value= 2.41||Improve your ability to perform activities in and out of your home||||.49
70872487|NCT02970422|141230495|OTHER|||||||0.93|||||||Chi-squared|Chi-squared value= .44||Prevent lung flare-ups||||.93
70872488|NCT02970422|141230495|OTHER|||||||0.6|||||||Chi-squared|Chi-squared value= 1.87||Discuss COPD and its progression||||.60
70872489|NCT02970422|141230495|OTHER|||||||0.31|||||||Chi-squared|Chi-squared value= 3.61||Improve your physical well-being||||.31
70872490|NCT02970422|141230496|OTHER|||||||0.73|||||||Chi-squared|Chi-squared value: 1.31||To relieve breathlessness in adults living with COPD||||.73
70872491|NCT02970422|141230496|OTHER|||||||0.23|||||||Chi-squared|Chi-squared value= 4.28||To prevent the development of COPD||||.23
70872492|NCT02970422|141230496|OTHER|||||||0.14|||||||Chi-squared|Chi-squared value= 5.51||To prevent lung flare-ups in adults living with COPD||||.14
70872493|NCT02970422|141230496|OTHER|||||||0.52|||||||Chi-squared|Chi-squared value= 2.28||To increase the ability of adults living with COPD to exercise||||.52
70872494|NCT02970422|141230496|OTHER|||||||0.11|||||||Chi-squared|Chi-squared value= 5.88||To improve the maximal amount of exercise of adults living with COPD in and out of the home||||.11
70872495|NCT02970422|141230496|OTHER|||||||0.14|||||||Chi-squared|Chi-squared value= 5.57||To relieve breathlessness in adults living with COPD||||.14
70872496|NCT02970422|141230496|OTHER|||||||0.73|||||||Chi-squared|Chi-squared value= 1.29||To prevent the development of COPD||||.73
70872497|NCT02970422|141230496|OTHER|||||||0.2|||||||Chi-squared|Chi-squared value= 4.64||To prevent lung flare-ups in adults living with COPD||||.20
70872498|NCT02970422|141230496|OTHER|||||||0.17|||||||Chi-squared|Chi-squared value= 5.02||To increase the ability of adults living with COPD to exercise||||.17
70872499|NCT02970422|141230496|OTHER|||||||0.02|||||||Chi-squared|Chi-square value= 9.97||To improve the maximal amount of exercise of adults living with COPD in and out of the home||||.02
70872500|NCT02970422|141230497|OTHER|||||||0.05|||||||Chi-squared|Chi squared value= 17.20||Activity 1: Walking from one place to another outside of your home on a flat surface||||.05
70872501|NCT02970422|141230497|OTHER|||||||0.87|||||||Chi-squared|Chi-squared value= 4.56||Activity 2: Moving from one place to another using motorized transportation||||.87
70872502|NCT02970422|141230497|OTHER|||||||0.65|||||||Chi-squared|Chi-squared value= 6.85||Activity 3: Climbing two or more flights of stairs||||.65
70872503|NCT02970422|141230497|OTHER|||||||0.35|||||||Chi-squared|Chi-squared value= 10.00||Activity 4: Walking up a hill||||.35
70872504|NCT02970422|141230497|OTHER|||||||0.03|||||||Chi-squared|Chi-squared value= 18.75||Activity 5: Participating in regular exercise requiring physical effort, to maintain or improve health or fitness||||.03
70872505|NCT02970422|141230497|OTHER|||||||0|||||||Chi-squared|Chi-squared value= 35.52||Activity 1: Walking from one place to another outside of your home on a flat surface||||.00
70872506|NCT02970422|141230497|OTHER|||||||0.33|||||||Chi-squared|Chi-squared value= 10.23||Activity 2: Moving from one place to another using motorized transportation||||.33
70872507|NCT02970422|141230497|OTHER|||||||0|||||||Chi-squared|Chi-squared value= 23.94||Activity 3: Climbing two or more flights of stairs||||.00
70872508|NCT02970422|141230497|OTHER|||||||0.01|||||||Chi-squared|Chi-squared value= 22.80||Activity 4: Walking up a hill||||.01
70872509|NCT02970422|141230497|OTHER|||||||0.02|||||||Chi-squared|Chi-squared value= 20.43||Activity 5: Participating in regular exercise requiring physical effort, to maintain or improve health or fitness||||.02
70872510|NCT02970422|141230498|OTHER|||||||0|||||||Kruskal-Wallis|Non-parametric led to equal variance (levene's test) which couldn't be assumed, independent samples were taken (Kruskal-Wallis)|||F(3,144)=137.82|||.00
70872511|NCT02970422|141230499|OTHER|||||||0|||||||ANOVA|Factorial ANOVA used because variance could be assumed|||F(3,144)=55.89 Partial ETA squared (effect size)=0.54|||.000
70872512|NCT02970422|141230500|OTHER|||||||0|||||||ANOVA|One-way ANOVA|||F(3,142)=7.61|||.00
70872513|NCT02970422|141230501|OTHER|||||||0.31|||||||ANOVA|One-way ANOVA|||F(3,142)=1.21|||.31
70872514|NCT02970422|141230502|OTHER|||||||0.04|||||||Kruskal-Wallis|Non-parametric independent sample Kruskal-Wallis test (failed variance assumed|||F(3,139)=8.09|||.04
70872515|NCT02970422|141230503|OTHER|||||||0|||||||ANOVA|One-way ANOVA|||F(3,143)=8.01|||.00
70872516|NCT01325584|141230518|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||.07
70872517|NCT01325584|141230520|SUPERIORITY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||.53
70872518|NCT01325584|141230521|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||.48
70872519|NCT00887978|141230522|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|10.0||||0.089|TWO_SIDED|95.0|-2.0|22.0|||non-parametric ANCOVA|||Using an allocation ratio of 1:1 between UT-15C SR and placebo, a fixed sample size of approximately 266 subjects would provide at least 90% power at a significance level of 0.05 (two-sided hypothesis) to detect a 30 meter between-treatment difference in the change from Baseline in distance traversed during the 6-Minute Walk, assuming a standard deviation of 75 meters. A total sample size of approximately 300 subjects was determined to account for discontinuations during the enrollment period.||22.0|-2.0|0.089
70872520|NCT00887978|141230523|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
70872521|NCT00887978|141230524|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L) Estimate|0.0||||0.22|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank sum test|||||0.0|-1.0|0.22
70872522|NCT00887978|141230525|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L) estimate|0.0||||0.43|TWO_SIDED|95.0|0.0|0.0||Imputation strategies were implemented for the 26 UT-15C subjects and 17 placebo subjects without values reported at Week 16.|Wilcoxon rank sum test|||||0.0|0.0|0.43
70872523|NCT00887978|141230527|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L) estimate|0.0||||0.3|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon rank sum test|||||1.0|0.0|0.30
70872524|NCT00887978|141230530|SUPERIORITY_OR_OTHER||Hodges-Lehman Estimate|14.0||||0.058|TWO_SIDED|95.0|0.0|28.0|||ANCOVA|||||28.0|0.0|0.058
70872525|NCT00887978|141230531|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|15.0||||0.054|TWO_SIDED|95.0|-1.0|29.0|||ANCOVA|||||29.0|-1.0|0.054
70872526|NCT00887978|141230533|SUPERIORITY_OR_OTHER||Hodges-Lehman Estimate|4.0||||0.674|TWO_SIDED|95.0|-16.0|24.0|||ANCOVA|||||24.0|-16.0|0.674
70872527|NCT00887978|141230534|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|28.0||||0.059|TWO_SIDED|95.0|1.0|59.0|||ANCOVA|||||59.0|1.0|0.059
70872528|NCT00887978|141230535|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|10.0||||0.22|TWO_SIDED|95.0|-10.0|31.0|||ANCOVA|||||31.0|-10.0|0.22
70872529|NCT00887978|141230536|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|3.0||||0.99|TWO_SIDED|95.0|-23.0|28.0|||ANCOVA|||||28.0|-23.0|0.99
70872530|NCT00887978|141230537|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-2.0||||0.84||95.0|-25.0|22.0|||ANCOVA|||||22.0|-25.0|0.84
70872531|NCT00534430|141230540|EQUIVALENCE|Given the small sample-size of the disease sub-groups, this was a hypothesis generating study.|Median Difference (Net)|0.0|||>|0.05|TWO_SIDED|||||Not adjusted for multiple comparisons. A-priori threshold for statistical significance was 0.05.|Log Rank|No adjustments.||Log-rank test. (Mantel-Haenszel test). Null hypothesis is all four groups are statistically from the same population. Alternative hypothesis is that at least one of the groups is from a population different from the remaining groups. Anticipated sample-sizes comparing Active ALL (anticipated N= 12) with the combined AML patients (anticipated N=38) was deemed to be too small for formal hypothesis testing.||||>0.05
70872532|NCT00534430|141230541|EQUIVALENCE|Given the small sample-size of the disease sub-groups, this was a hypothesis generating study.|Median Difference (Net)|0.0|||>|0.05|TWO_SIDED|||||Not adjusted for multiple comparisons. A-priori threshold for statistical significance was 0.05.|Gray's Test|No adjustments.||Gray's estimate. (Fine and Gray). Null hypothesis is all four groups are statistically from the same population. Alternative hypothesis is that at least one of the groups is from a population different from the remaining groups. Anticipated sample-sizes comparing Active ALL (anticipated N= 12) with the combined AML patients (anticipated N=38) was deemed to be too small for formal hypothesis testing||||>0.05
70872533|NCT00309387|141230544|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.82||||0.03|TWO_SIDED|95.0|0.68|0.98|||Regression, Cox|||||0.98|0.68|0.03
70872534|NCT00616200|141230552|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|||Sickness Impact Profile scores improved.||||.001
70872535|NCT02483520|141230554|SUPERIORITY||LSM Estimate|0.03||||0.977|TWO_SIDED|95.0|-2.02|2.08|||Mixed Models Analysis|||Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.||2.08|-2.02|.977
70872536|NCT02483520|141230555|SUPERIORITY||LSM Estimate|-0.22||||0.812|TWO_SIDED|95.0|-2.09|1.64|||Mixed Models Analysis|||Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.||1.64|-2.09|.812
70872537|NCT02483520|141230558|SUPERIORITY||LSM Estimate|-1.5||||0.343|TWO_SIDED|95.0|-4.64|1.64|||Mixed Models Analysis|||Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.||1.64|-4.64|.343
70872538|NCT02483520|141230559|SUPERIORITY||LSM Estimate|-4.79||||0.012|TWO_SIDED|95.0|-8.51|-1.08|||Mixed Models Analysis|||Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.||-1.08|-8.51|.012
70872539|NCT02483520|141230560|SUPERIORITY||LSM Estimate|0.77||||0.033|TWO_SIDED|95.0|0.07|1.47|||Mixed Models Analysis|||Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.||1.47|0.07|.033
70872540|NCT02483520|141230563|SUPERIORITY|||||||0.211|||||||Wilcoxon (Mann-Whitney)|||p-values were calculated for differences between mean group changes using Wilcoxon rank-sum test at 3 months||||.211
70872541|NCT02483520|141230563|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||p-values were calculated for within- group changes using Wilcoxon signed-rank test between baseline and 3 months||||<.001
70872542|NCT02483520|141230564|SUPERIORITY|||||||0.476|||||||Wilcoxon (Mann-Whitney)|||p-values were calculated for differences between mean group changes using Wilcoxon rank-sum test at 3 months||||.476
70872543|NCT02483520|141230564|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||p-values were calculated for within- group changes using Wilcoxon signed-rank test between baseline and 3 months||||.005
70872544|NCT02483520|141230565|SUPERIORITY|||||||0.677|||||||Wilcoxon (Mann-Whitney)|||p-values were calculated for differences between mean group changes using Wilcoxon rank-sum test at 3 months||||.677
70872545|NCT02483520|141230565|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||p-values were calculated for within- group changes using Wilcoxon signed-rank test between baseline and 3 months||||.020
70872546|NCT02483520|141230566|SUPERIORITY||LSM Estimate|-0.62||||0.432|TWO_SIDED|95.0|-2.18|0.94|||Mixed Models Analysis|||Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.||0.94|-2.18|.432
70872547|NCT02483520|141230567|SUPERIORITY|||||||0.255|||||||Wilcoxon (Mann-Whitney)|||||||.255
70872548|NCT04492618|141230573|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
70872549|NCT02111772|141230582|SUPERIORITY|||||||0.049|||||||Negative binomial regression|||||||0.049
70872550|NCT02111772|141230583|SUPERIORITY||||||<|0.001|||||||Negative binomial regression|||||||<0.001
70872551|NCT01246401|141230594|SUPERIORITY|||||||0.431|||||||Welch's T Test|||||||0.431
70872552|NCT01246401|141230595|SUPERIORITY|||||||0.087|||||||Welch's T Test|||||||0.087
70872553|NCT01246401|141230597|SUPERIORITY|||||||0.03||||||Wilcoxon one sided|Wilcoxon (Mann-Whitney)|||||||0.03
70872554|NCT01246401|141230602|SUPERIORITY|||||||0.03962|||||||Chi-squared|||||||0.03962
70872555|NCT03462082|141230604|SUPERIORITY|||||||0.163||||||"Holm-adjusted P-Value: 0.326~\*Gait Velocity for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.163
70872556|NCT03462082|141230604|SUPERIORITY|||||||0.749||||||"Holm-adjusted P-Value: 0.749~\*Gait Velocity for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.749
70872557|NCT03462082|141230605|SUPERIORITY|||||||0.031||||||"Holm-adjusted P-Value: 0.155~\*MDS-UPDRS (total) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to report the changes associated with the 2 asymmetric conditions.||||0.031
70872558|NCT03462082|141230605|SUPERIORITY|||||||0.778||||||"Holm-adjusted P-Value: 0.902~\*MDS-UPDRS total for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to report the changes associated with the 2 asymmetric conditions.||||0.778
70872559|NCT03462082|141230605|SUPERIORITY|||||||0.039||||||"Holm-adjusted P-Value: 0.157~\*MDS-UPDRS (motor) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.039
70872560|NCT03462082|141230605|SUPERIORITY|||||||0.451||||||"Holm-adjusted P-Value: 0.902~\*MDS-UPDRS (motor) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.451
70872561|NCT03462082|141230605|SUPERIORITY|||||||0.111||||||"Holm-adjusted P-Value: 0.333~\*MDS-UPDRS (axial motor) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.111
70872562|NCT03462082|141230605|SUPERIORITY|||||||0.005||||||"Holm-adjusted P-Value: 0.030~\*MDS-UPDRS (axial motor) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.005
70872563|NCT03462082|141230606|SUPERIORITY|||||||0.984||||||Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.984
70872564|NCT03462082|141230606|SUPERIORITY|||||||0.067||||||Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.067
70872565|NCT03462082|141230607|SUPERIORITY|||||||0.44||||||Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.440
70872566|NCT03462082|141230607|SUPERIORITY|||||||0.051||||||Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.051
70872567|NCT03462082|141230608|SUPERIORITY|||||||0.945||||||Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.945
70872568|NCT03462082|141230608|SUPERIORITY|||||||0.024||||||Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.024
70872569|NCT03462082|141230609|SUPERIORITY|||||||0.097||||||"Holm-adjusted P-Value: 1.00~\*Gait velocity for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.097
70872570|NCT03462082|141230609|SUPERIORITY|||||||0.75||||||"Holm-adjusted P-Value: 1.00~\*Gait velocity for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.750
70872571|NCT03462082|141230610|SUPERIORITY|||||||0.128||||||"Holm-adjusted P-Value: 1.00~\*Step length (mean) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.128
70872572|NCT03462082|141230610|SUPERIORITY|||||||0.117||||||"Holm-adjusted P-Value: 1.00~\*Step length (mean) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.117
70872573|NCT03462082|141230610|SUPERIORITY|||||||0.145||||||"Holm-adjusted P-Value: 1.00~\*Step length (right) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.145
70872574|NCT03462082|141230610|SUPERIORITY|||||||0.056||||||"Holm-adjusted P-Value: 1.00~\*Step length (right) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.056
70872575|NCT03462082|141230610|SUPERIORITY|||||||0.151||||||"Holm-adjusted P-Value: 1.00~\*Step length (left) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.151
70872576|NCT03462082|141230610|SUPERIORITY|||||||0.129||||||"Holm-adjusted P-Value: 1.00~\*Step length (left) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.129
70872577|NCT03462082|141230610|SUPERIORITY|||||||0.698||||||"Holm-adjusted P-Value: 1.00~\*Step length difference for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.698
70872578|NCT03462082|141230610|SUPERIORITY|||||||0.779||||||"Holm-adjusted P-Value: 1.00~\*Step length difference for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.779
70872579|NCT03462082|141230611|SUPERIORITY|||||||0.874||||||"Holm-adjusted P-Value: 1.00~\*Step length ratio for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.874
70872580|NCT03462082|141230611|SUPERIORITY|||||||0.976||||||"Holm-adjusted P-Value: 1.00~\*Step length ratio for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.976
70872581|NCT03462082|141230611|SUPERIORITY|||||||0.859||||||"Holm-adjusted P-Value: 1.00~\*Step length symmetry for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.859
70872582|NCT03462082|141230611|SUPERIORITY|||||||0.86||||||"Holm-adjusted P-Value: 1.00~\*Step length symmetry for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.860
70872583|NCT03462082|141230612|SUPERIORITY|||||||0.04||||||"Holm-adjusted P-Value: 0.480~\*Pitch (minimum) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.040
70872584|NCT03462082|141230612|SUPERIORITY|||||||0.883||||||"Holm-adjusted P-Value: 1.00~\*Pitch (minimum) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.883
70872585|NCT03462082|141230612|SUPERIORITY|||||||0.071||||||"Holm-adjusted P-Value: 0.781~\*Pitch (maximum) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.071
70872586|NCT03462082|141230612|SUPERIORITY|||||||0.327||||||"Holm-adjusted P-Value: 1.00~\*Pitch (maximum) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.327
70872587|NCT03462082|141230613|SUPERIORITY|||||||0.487||||||"Holm-adjusted P-Value: 1.00~\*Loudness (minimum) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.487
70872588|NCT03462082|141230613|SUPERIORITY|||||||0.861||||||"Holm-adjusted P-Value: 1.00~\*Loudness (minimum) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.861
70872589|NCT03462082|141230613|SUPERIORITY|||||||0.411||||||"Holm-adjusted P-Value: 1.00~\*Loudness (maximum) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.411
70872590|NCT03462082|141230613|SUPERIORITY|||||||0.997||||||"Holm-adjusted P-Value: 1.00~\*Loudness (maximum) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.997
70872591|NCT03462082|141230614|SUPERIORITY|||||||0.388||||||"Holm-adjusted P-Value: 1.00~\*Jitter for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.388
70872592|NCT03462082|141230614|SUPERIORITY|||||||0.684||||||"Holm-adjusted P-Value: 1.00~\*Jitter for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.684
70872593|NCT03462082|141230615|SUPERIORITY|||||||0.85||||||"Holm-adjusted P-Value: 1.00~\*Shimmer for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.850
70872594|NCT03462082|141230615|SUPERIORITY|||||||0.712||||||"Holm-adjusted P-Value: 1.00~\*Shimmer for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.712
70872595|NCT03462082|141230616|SUPERIORITY|||||||0.501|||||||Mixed Models Analysis|Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.501
70872596|NCT03462082|141230616|SUPERIORITY|||||||0.216||||||Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.216
70872597|NCT03462082|141230617|SUPERIORITY||||||>|0.05||||||Non-adjusted P-Values were \>0.05 and Holm-adjusted P-Values were 1.00 for all comparisons, except for the Hopkins Verbal Learning Test-Revised: Delayed Recall. For this test, the non-adjusted P-Value was 0.04 and the Holm-adjusted P-Value was 0.44.|Friedman test|Using ranks for repeated measures (3 conditions)||||||>0.05
70872598|NCT00919724|141230618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99|STANDARD_ERROR_OF_MEAN|0.6||0.1||||||Comparison between HIV-infected and HIV-uninfected groups. Comparison adjusted for age, gender, race, height, and brachial artery baseline diameter.|Regression, Linear|||||||0.10
70872599|NCT00166114|141230619|SUPERIORITY_OR_OTHER|||||||0.918|||||||Chi-squared|||Chi Square test was performed comparing actual vs. expected non- and partial response or response to either escitalopram or desipramine treatment.||||.918
70872600|NCT01218204|141230660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.473|||||TWO_SIDED|95.0|-15.7096|26.6553|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 10 mg + GSK1292263 100 mg vs Placebo: Apolipoprotein A1||26.6553|-15.7096|
70872601|NCT01218204|141230660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.598|||||TWO_SIDED|95.0|-21.784|20.5888|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 10 mg + GSK1292263 300 mg vs Placebo: Apolipoprotein A1||20.5888|-21.7840|
70872602|NCT01218204|141230660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.906|||||TWO_SIDED|95.0|-9.3489|33.1602|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 10 mg + GSK1292263 800 mg vs Placebo: Apolipoprotein A1||33.1602|-9.3489|
70872603|NCT01218204|141230660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.671|||||TWO_SIDED|95.0|-16.9957|24.3384|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 10 mg + Ezetimibe 10 mg vs Placebo: Apolipoprotein A1||24.3384|-16.9957|
70872604|NCT01218204|141230660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.618|||||TWO_SIDED|95.0|-28.2069|37.4425|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 80 mg + GSK1292263 800 mg vs Placebo: Apolipoprotein A1||37.4425|-28.2069|
70872605|NCT01218204|141230660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.713|||||TWO_SIDED|95.0|-17.0405|39.8527|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 100 mg vs Placebo: Apolipoprotein A1||39.8527|-17.0405|
70872606|NCT01218204|141230660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.934|||||TWO_SIDED|95.0|-21.0153|31.5504|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 300 mg vs Placebo: Apolipoprotein A1||31.5504|-21.0153|
70872607|NCT01218204|141230660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.466|||||TWO_SIDED|95.0|-23.7517|24.7608|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 800 mg vs Placebo: Apolipoprotein A1||24.7608|-23.7517|
70872608|NCT01218204|141230660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.743|||||TWO_SIDED|95.0|-3.246|33.7161|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 10 mg + GSK1292263 100 mg vs Placebo: Apolipoprotein B100||33.7161|-3.2460|
70872609|NCT01218204|141230660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.428|||||TWO_SIDED|95.0|-21.3243|8.9224|||||Statistical analysis was performed using LS mean value Atorvastatin|Atorvastatin 10 mg + GSK1292263 300 mg vs Placebo: Apolipoprotein B100||8.9224|-21.3243|
70872610|NCT01218204|141230660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.96|||||TWO_SIDED|95.0|-26.8137|1.1513|||||Statistical analysis was performed using LS mean value Atorvastatin|Atorvastatin 10 mg + GSK1292263 800 mg vs Placebo: Apolipoprotein B100||1.1513|-26.8137|
70872611|NCT01218204|141230660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.903|||||TWO_SIDED|95.0|-16.6557|13.1191|||||Statistical analysis was performed using LS mean value Atorvastatin|Atorvastatin 10 mg + Ezetimibe 10 mg vs Placebo: Apolipoprotein B100||13.1191|-16.6557|
70872612|NCT01218204|141230660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.231|||||TWO_SIDED|95.0|-45.1045|-11.3579|||||Statistical analysis was performed using LS mean value Atorvastatin|Atorvastatin 80 mg + GSK1292263 800 mg vs Placebo: Apolipoprotein B100||-11.3579|-45.1045|
70872613|NCT01218204|141230660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.1|||||TWO_SIDED|95.0|-23.5021|11.3014|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 100 mg vs Placebo: Apolipoprotein B100||11.3014|-23.5021|
70872614|NCT01218204|141230660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.49|||||TWO_SIDED|95.0|-25.2721|8.2918|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 300 mg vs Placebo: Apolipoprotein B100||8.2918|-25.2721|
70872615|NCT01218204|141230660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.687|||||TWO_SIDED|95.0|-26.0247|6.6498|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 800 mg vs Placebo: Apolipoprotein B100||6.6498|-26.0247|
70872616|NCT01218204|141230661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.471|||||TWO_SIDED|95.0|-47.9323|3.202|||||Statistical analysis was performed using LS mean value Atorvastatin|||3.2020|-47.9323|
70872617|NCT01218204|141230661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.91|||||TWO_SIDED|95.0|-38.1027|25.3126|||||Statistical analysis was performed using LS mean value Atorvastatin|||25.3126|-38.1027|
70872618|NCT01218204|141230661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-25.985|||||TWO_SIDED|95.0|-45.5492|1.8605|||||Statistical analysis was performed using LS mean value Atorvastatin|||1.8605|-45.5492|
70872619|NCT01218204|141230661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.697|||||TWO_SIDED|95.0|-45.0846|13.3024|||||Statistical analysis was performed using LS mean value Atorvastatin|||13.3024|-45.0846|
70872620|NCT01218204|141230661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.036|||||TWO_SIDED|95.0|-27.2281|15.1569|||||Statistical analysis was performed using LS mean value of Atorvastatin|||15.1569|-27.2281|
70872621|NCT01218204|141230661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.198|||||TWO_SIDED|95.0|-24.2901|32.6057|||||Statistical analysis was performed using LS mean value of GSK1292263|||32.6057|-24.2901|
70872622|NCT01218204|141230661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.117|||||TWO_SIDED|95.0|-40.4767|1.906|||||Statistical analysis was performed using LS mean value of GSK1292263|||1.9060|-40.4767|
70872623|NCT01218204|141230661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-32.798|||||TWO_SIDED|95.0|-48.3842|-12.5064|||||Statistical analysis was performed using LS mean value of GSK1292263|||-12.5064|-48.3842|
70872624|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.101|||||TWO_SIDED|95.0|-4.5469|14.7495|||||Statistical analysis was performed using LS mean value of Atorvastatin|For HDLc||14.7495|-4.5469|
70872625|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.273|||||TWO_SIDED|95.0|2.5937|21.9532|||||Statistical analysis was performed using LS mean value of Atorvastatin|Fo HDLc||21.9532|2.5937|
70872626|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.833|||||TWO_SIDED|95.0|18.955|38.7102|||||Statistical analysis was performed using LS mean value of Atorvastatin|For HDLc||38.7102|18.9550|
70872627|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.701|||||TWO_SIDED|95.0|-5.5562|12.9578|||||Statistical analysis was performed using LS mean value of Atorvastatin|For HDLc||12.9578|-5.5562|
70872628|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.946|||||TWO_SIDED|95.0|8.612|33.281|||||Statistical analysis was performed using LS mean value of Atorvastatin|For HDLc||33.2810|8.6120|
70872629|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Median Difference (Net)|10.561|||||TWO_SIDED|95.0|-0.9675|22.0898|||||Statistical analysis was performed using LS mean value of GSK1292263|For HDLc||22.0898|-0.9675|
70872630|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.122|||||TWO_SIDED|95.0|-0.2902|22.5351|||||Statistical analysis was performed using LS mean value of GSK1292263|For HDLc||22.5351|-0.2902|
70872631|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.689|||||TWO_SIDED|95.0|9.7527|31.6262|||||Statistical analysis was performed using LS mean value of GSK1292263|For HDLc||31.6262|9.7527|
70872632|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.549|||||TWO_SIDED|95.0|-18.775|9.6768|||||Statistical analysis was performed using LS mean value of Atorvastatin|For LDLc||9.6768|-18.7750|
70872633|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.337|||||TWO_SIDED|95.0|-24.4549|3.7803|||||Statistical analysis was performed using LS mean value of Atorvastatin|For LDLc||3.7803|-24.4549|
70872634|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.317|||||TWO_SIDED|95.0|-36.0144|-6.619|||||Statistical analysis was performed using LS mean value of Atorvastatin|For LDLc||-6.6190|-36.0144|
70872635|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.173|||||TWO_SIDED|95.0|-34.271|-6.0755|||||Statistical analysis was performed using LS mean value of Atorvastatin|For LDLc||-6.0755|-34.2710|
70872636|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-25.472|||||TWO_SIDED|95.0|-49.3385|-8.1558|||||Statistical analysis was performed using LS mean value of Atorvastatin|For LDLc||-8.1558|-49.3385|
70872637|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.128|||||TWO_SIDED|95.0|-23.3049|-0.9514|||||Statistical analysis was performed using LS mean value of GSK1292263|For LDLc||-0.9514|-23.3049|
70872638|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.798|||||TWO_SIDED|95.0|-27.1364|-4.4589|||||Statistical analysis was performed using LS mean value of GSK1292263|For LDLc||-4.4589|-27.1364|
70872639|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.789|||||TWO_SIDED|95.0|-32.3413|-11.2372|||||Statistical analysis was performed using LS mean value of GSK1292263|For LDLc||-11.2372|-32.3413|
70872640|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.498|||||TWO_SIDED|95.0|-38.446|-2.4169|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Triglycerides||-2.4169|-38.4460|
70872641|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.781|||||TWO_SIDED|95.0|-39.1603|-4.513|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Triglycerides||-4.5130|-39.1603|
70872642|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-39.923|||||TWO_SIDED|95.0|-52.3394|-24.2717|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Triglycerides||-24.2717|-52.3394|
70872643|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.444|||||TWO_SIDED|95.0|-33.502|2.491|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Triglycerides||2.4910|-33.5020|
70872644|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.781|||||TWO_SIDED|95.0|-40.296|-3.2667|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Triglycerides||-3.2667|-40.2960|
70872645|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.421|||||TWO_SIDED|95.0|-38.3519|-4.4911|||||Statistical analysis was performed using LS mean value of GSK1292263|For Triglycerides||-4.4911|-38.3519|
70872646|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-46.361|||||TWO_SIDED|95.0|-63.465|-29.2561|||||Statistical analysis was performed using LS mean value of GSK1292263|For Triglycerides||-29.2561|-63.4650|
70872647|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-54.843|||||TWO_SIDED|95.0|-70.7854|-38.9007|||||Statistical analysis was performed using LS mean value of GSK1292263|For Triglycerides||-38.9007|-70.7854|
70872648|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.756|||||TWO_SIDED|95.0|-21.7561|2.2448|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Non-HDLc||2.2448|-21.7561|
70872649|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.014|||||TWO_SIDED|95.0|-25.7497|-2.2787|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Non-HDLc||-2.2787|-25.7497|
70872650|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-27.675|||||TWO_SIDED|95.0|-39.8454|-15.5045|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Non-HDLc||-15.5045|-39.8454|
70872651|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.937|||||TWO_SIDED|95.0|-32.6057|-9.269|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Non-HDLc||-9.2690|-32.6057|
70872652|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.702|||||TWO_SIDED|95.0|-29.0346|-14.3696|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Non-HDLc||-14.3696|-29.0346|
70872653|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.18|||||TWO_SIDED|95.0|-23.0636|-3.2961|||||Statistical analysis was performed using LS mean value of GSK1292263|For Non-HDLc||-3.2961|-23.0636|
70872654|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.151|||||TWO_SIDED|95.0|-31.942|-12.3605|||||Statistical analysis was performed using LS mean value of GSK1292263|For Non-HDLc||-12.3605|-31.9420|
70872655|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.948|||||TWO_SIDED|95.0|-36.2874|-17.6092|||||Statistical analysis was performed using LS mean value of GSK1292263|For Non-HDLc||-17.6092|-36.2874|
70872656|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.904|||||TWO_SIDED|95.0|-11.8484|4.04|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Cholesterol||4.0400|-11.8484|
70872657|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.437|||||TWO_SIDED|95.0|-14.346|1.4722|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Cholesterol||1.4722|-14.3460|
70872658|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.294|||||TWO_SIDED|95.0|-18.3923|-2.196|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Cholesterol||-2.1960|-18.3923|
70872659|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.065|||||TWO_SIDED|95.0|-19.7688|-4.3609|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Cholesterol||-4.3609|-19.7688|
70872660|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.941|||||TWO_SIDED|95.0|-13.9778|-1.9039|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Cholesterol||-1.9039|-13.9778|
70872661|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.384|||||TWO_SIDED|95.0|-15.9023|-0.866|||||Statistical analysis was performed using LS mean value of GSK1292263|For Cholesterol||-0.8660|-15.9023|
70872662|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.7|||||TWO_SIDED|95.0|-23.1404|-8.2592|||||Statistical analysis was performed using LS mean value of GSK1292263|For Cholesterol||-8.2592|-23.1404|
70872663|NCT01218204|141230662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.728|||||TWO_SIDED|95.0|-23.8395|-9.6161||||||For Cholesterol||-9.6161|-23.8395|
70872664|NCT01218204|141230663|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.123|||||TWO_SIDED|95.0|-26.6276|2.3814|||||Statistical analysis was performed using LS mean value of Atorvastatin|||2.3814|-26.6276|
70872665|NCT01218204|141230663|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.63|||||TWO_SIDED|95.0|-35.9419|-7.3181|||||Statistical analysis was performed using LS mean value of Atorvastatin|||-7.3181|-35.9419|
70872666|NCT01218204|141230663|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-41.506|||||TWO_SIDED|95.0|-56.3924|-26.6205|||||Statistical analysis was performed using LS mean value of Atorvastatin|||-26.6205|-56.3924|
70872667|NCT01218204|141230663|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.041|||||TWO_SIDED|95.0|-42.2554|-13.8263|||||Statistical analysis was performed using LS mean value of Atorvastatin|||-13.8263|-42.2554|
70872668|NCT01218204|141230663|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.293|||||TWO_SIDED|95.0|-51.5654|-12.4042|||||Statistical analysis was performed using LS mean value of Atorvastatin|||-12.4042|-51.5654|
70872669|NCT01218204|141230663|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.042|||||TWO_SIDED|95.0|-34.8358|-5.2472|||||Statistical analysis was performed using LS mean value of GSK1292263|||-5.2472|-34.8358|
70872670|NCT01218204|141230663|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.903|||||TWO_SIDED|95.0|-36.6155|-7.1913|||||Statistical analysis was performed using LS mean value of GSK1292263|||-7.1913|-36.6155|
70872671|NCT01218204|141230663|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-35.735|||||TWO_SIDED|95.0|-49.722|-21.7485|||||Statistical analysis was performed using LS mean value of GSK1292263|||-21.7485|-49.7220|
70872672|NCT01218204|141230664|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.409|||||TWO_SIDED|95.0|-1.0123|0.1942|||||Statistical analysis was performed using LS mean value of Atorvastatin|||0.1942|-1.0123|
70872673|NCT01218204|141230664|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.296|||||TWO_SIDED|95.0|-0.9063|0.3141|||||Statistical analysis was performed using LS mean value of Atorvastatin|||0.3141|-0.9063|
70872674|NCT01218204|141230664|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.811|||||TWO_SIDED|95.0|-1.4125|-0.2098|||||Statistical analysis was performed using LS mean value of Atorvastatin|||-0.2098|-1.4125|
70872675|NCT01218204|141230664|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.422|||||TWO_SIDED|95.0|-0.9831|0.1394|||||Statistical analysis was performed using LS mean value of Atorvastatin|||0.1394|-0.9831|
70872676|NCT01218204|141230664|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.384|||||TWO_SIDED|95.0|-0.6009|-0.1669|||||Statistical analysis was performed using LS mean value of Atorvastatin|||-0.1669|-0.6009|
70872677|NCT01218204|141230664|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.648|||||TWO_SIDED|95.0|-1.1657|-0.1302|||||Statistical analysis was performed using LS mean value of GSK1292263|||-0.1302|-1.1657|
70872678|NCT01218204|141230664|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.782|||||TWO_SIDED|95.0|-1.2804|-0.2844|||||Statistical analysis was performed using LS mean value of GSK1292263|||-0.2844|-1.2804|
70872679|NCT01218204|141230664|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.884|||||TWO_SIDED|95.0|-1.3652|-0.4026|||||Statistical analysis was performed using LS mean value of GSK1292263|||-0.4026|-1.3652|
70872680|NCT03266107|141230699|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
70872681|NCT03266107|141230700|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
70872682|NCT03266107|141230703|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
70872683|NCT03454997|141230708|SUPERIORITY||Mean Difference (Net)|5.5|||||TWO_SIDED|95.0|3.9|7.1||||||comparison of baseline and 6 months across both groups||7.1|3.9|
70872684|NCT03454997|141230708|SUPERIORITY||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-2.3|1.1||||||between groups differences of change between baseline and 6 months||1.1|-2.3|
70872685|NCT03454997|141230709|SUPERIORITY||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-1.4|0.4||||||leading behavioral weight loss group baseline to 6 months comparison||0.4|-1.4|
70872686|NCT03454997|141230709|SUPERIORITY||Mean Difference (Net)|-0.05|||||TWO_SIDED|95.0|-2.0|1.0||||||leading behavioral weight loss group between group comparison of change||1.0|-2.0|
70872687|NCT03454997|141230709|SUPERIORITY||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-1.4|0.2||||||completing weight ins baseline to 6 month comparison||0.2|-1.4|
70872688|NCT03454997|141230709|SUPERIORITY||Mean Difference (Net)|-1.0|||||TWO_SIDED|95.0|-2.5|0.5||||||completing weigh ins between groups comparison of change||0.5|-2.5|
70872689|NCT03454997|141230709|SUPERIORITY||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-1.2|0.3||||||managing a group session baseline to 6 months comparison||0.3|-1.2|
70872690|NCT03454997|141230709|SUPERIORITY||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-2.0|1.1||||||managing a group session between groups comparison of change||1.1|-2.0|
70872691|NCT03454997|141230710|SUPERIORITY||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|-2.0|2.9||||||comparison between baseline and 6 months across groups||2.9|-2.0|
70872692|NCT03454997|141230710|SUPERIORITY||Mean Difference (Net)|-4.1|||||TWO_SIDED|95.0|-9.1|0.8||||||between groups comparison of change post training to 6 months||0.8|-9.1|
70872693|NCT03454997|141230711|SUPERIORITY||Mean Difference (Net)|-3.3|||||TWO_SIDED|95.0|-6.9|0.3||||||comparison of baseline to 6 months across both groups||0.3|-6.9|
70872694|NCT03454997|141230711|SUPERIORITY||Mean Difference (Net)|-4.8|||||TWO_SIDED|95.0|-11.4|1.8||||||comparison of between group differences baseline to 6 months||1.8|-11.4|
70872695|NCT03454997|141230712|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-0.4|1.1||||||Comparison of Baseline \& 6 Months across both groups||1.1|-0.4|
70872696|NCT03454997|141230712|SUPERIORITY||Mean Difference (Net)|-0.9|||||TWO_SIDED|95.0|-2.0|0.2||||||Between Groups Differences of Change between Baseline \& 6 Months||0.2|-2.0|
70872697|NCT03454997|141230713|SUPERIORITY||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-4.5|3.3||||||comparison of between group differences baseline to 6 months||3.3|-4.5|
70872698|NCT03454997|141230713|SUPERIORITY||Mean Difference (Net)|-1.6|||||TWO_SIDED|95.0|-3.1|0.2||||||comparison of baseline to 6 months across groups||0.2|-3.1|
70872699|NCT03454997|141230714|SUPERIORITY||Mean Difference (Net)|-3.8|||||TWO_SIDED|95.0|-6.1|-1.6||||||comparison of baseline and 6 months across groups||-1.6|-6.1|
70872700|NCT03454997|141230714|SUPERIORITY||Mean Difference (Net)|-6.6|||||TWO_SIDED|95.0|-20.2|6.9||||||between groups differences of change between baseline to 6 months||6.9|-20.2|
70872701|NCT01191801|141230755|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.87||||0.0305|ONE_SIDED|95.0||||Unstratified one sided P-Value|Unstratified Log Rank|Since the sample size was increased, the primary analysis used the weighted statistic proposed by Cui, Hung, and Wang (Cui 1999).||||||0.0305
70872702|NCT01191801|141230756|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Two sided P-Value|Chi-squared|||||||<0.0001
70872703|NCT01191801|141230759|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Two sided P-Value|Chi-squared|||||||<0.0001
70872704|NCT01191801|141230760|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67|||<|0.0001|ONE_SIDED|95.0||||Unstratified one-sided P-Value|Log Rank|||||||<0.0001
70872705|NCT01191801|141230761|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.3134|TWO_SIDED|95.0||||One sided P-Value|Log Rank|||||||0.3134
71145828|NCT02977403|141785388|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.036|||||TWO_SIDED|95.0|-0.047|0.119||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.119|-0.047|
71145829|NCT02977403|141785388|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.106|||||TWO_SIDED|95.0|-0.276|0.064||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.064|-0.276|
70872706|NCT00114101|141230807|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This study was designed to have 80% power, with the use of the log-rank test at a one-sided significance level of 0.05, to detect a hazard ratio of 1.4, assuming proportional hazards and an exponential time to event distribution. Under the assumed framework, 309 events were expected. The expected drop out rate before randomization was 15%.|Hazard Ratio (HR)|0.36|||<|0.001|TWO_SIDED|95.0|0.26|0.53||Participants were randomized with the use of a permuted-block design stratified by beta 2 microglobulin, prior use of thalidomide and prior use of lenalidomide. TTP was monitored with the use of a group sequential design for superiority and futility.|Log Rank|||||0.53|0.26|<0.001
70872707|NCT00114101|141230809|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.52||||0.7|TWO_SIDED|95.0|0.26|1.02|||Log Rank|||||1.02|0.26|0.70
70872708|NCT00114101|141230810|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.53|||<|0.001|TWO_SIDED|95.0|0.41|0.69|||Fisher Exact|||||0.69|0.41|<0.001
70872709|NCT00299975|141230832|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Chi-squared|Chi-squared test from Crosstabs analysis.||||||<0.05
70872710|NCT00299975|141230833|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|Chi-squared test from Crosstabs analysis.||||||<0.05
70872711|NCT00299975|141230834|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
70872712|NCT00299975|141230835|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
70872713|NCT00299975|141230836|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|Chi-squared test from Crosstabs analysis was implemented between three treatment groups in each time frame.||||||<0.05
70872714|NCT00299975|141230837|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
70872715|NCT00299975|141230838|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
70872716|NCT00299975|141230839|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
70872717|NCT00299975|141230840|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
70872718|NCT00299975|141230841|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
70872719|NCT00299975|141230842|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
70872720|NCT00299975|141230844|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
70872721|NCT00299975|141230845|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
70872722|NCT00299975|141230846|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
70872723|NCT00299975|141230847|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
70872724|NCT05025241|141230868|OTHER||||||<|0.0001|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||<0.0001
70872725|NCT05025241|141230869|OTHER|||||||0.0003|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0003
70872726|NCT05025241|141230870|OTHER|Change from baseline||||||0.0156|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0156
70872727|NCT05025241|141230871|OTHER|Change from baseline||||||0.0005|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0005
70872728|NCT05025241|141230872|OTHER|||||||0.0647|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants.||||0.0647
70872729|NCT05025241|141230873|OTHER|Change from baseline||||||0.0984|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0984
70872730|NCT05025241|141230874|OTHER|Change from baseline||||||0.0013|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0013
70872731|NCT05025241|141230875|OTHER|Change from baseline||||||0.0191|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0191
70872732|NCT05025241|141230876|OTHER|change from baseline||||||0.0013|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0013
70872733|NCT05025241|141230877|OTHER|change from baseline||||||0.171|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.1710
70872734|NCT05025241|141230878|OTHER|change from baseline||||||0.0066|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0066
70872735|NCT05025241|141230879|OTHER|change form baseline||||||0.1094|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.1094
70872736|NCT05025241|141230880|OTHER|change from baseline||||||0.0156|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0156
70872737|NCT05025241|141230881|OTHER|change from baseline||||||0.0326|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0326
70872738|NCT02397785|141230910|SUPERIORITY|||||||0.8979|||||||t-test, 2 sided|||It was calculated that 52 participants (26 in each arm) was sufficient to detect a 30% reduction in the VAS score (⍺ = 0.05, β = 0.80) from baseline to 12 weeks using paired t-tests, assuming average pain of 80-90 on the VAS and 10% drop-out. Because stratified randomization was performed on the basis of levator ani muscle spasm, there was an imbalance between the size of the sham and active groups, and 58 subjects were ultimately recruited with approval from the Institutional Review Board.||||0.8979
70872739|NCT02397785|141230911|SUPERIORITY|||||||0.9338|||||||Sign test|||||||0.9338
70872740|NCT02397785|141230912|SUPERIORITY|||||||0.1568|||||||Sign test|||||||0.1568
70872741|NCT02397785|141230913|SUPERIORITY|||||||0.3817|||||||Sign test|||||||0.3817
70872742|NCT02397785|141230914|SUPERIORITY|||||||0.286|||||||Sign test|||||||0.2860
70872743|NCT02397785|141230915|SUPERIORITY|||||||0.2884|||||||Sign test|||||||0.2884
70872744|NCT02397785|141230916|SUPERIORITY|||||||0.0855|||||||Sign test|||||||0.0855
70872745|NCT02397785|141230917|SUPERIORITY|||||||0.0287|||||||Sign test|||||||0.0287
70872746|NCT02397785|141230918|SUPERIORITY|||||||0.2887|||||||Sign test|||||||0.2887
70872747|NCT02397785|141230919|SUPERIORITY|||||||0.9954|||||||Sign test|||||||0.9954
70872748|NCT02397785|141230920|SUPERIORITY|||||||0.0574|||||||Sign test|||||||0.0574
70872749|NCT02397785|141230921|SUPERIORITY|||||||0.7827|||||||Sign test|||||||0.7827
70872750|NCT02397785|141230922|SUPERIORITY|||||||0.2114|||||||Sign test|||||||0.2114
70872751|NCT02397785|141230923|SUPERIORITY|||||||0.4986|||||||Sign test|||||||0.4986
70872752|NCT02397785|141230924|SUPERIORITY|||||||0.461|||||||Sign test|||||||0.4610
70872753|NCT02397785|141230925|SUPERIORITY|||||||0.2556|||||||Sign test|||||||0.2556
70872754|NCT02397785|141230926|SUPERIORITY|||||||0.0723|||||||t-test, 2 sided|||||||0.0723
70872755|NCT02397785|141230927|SUPERIORITY|||||||0.7456|||||||t-test, 2 sided|||||||0.7456
70872756|NCT02397785|141230928|SUPERIORITY|||||||0.138|||||||t-test, 2 sided|||||||0.1380
70872757|NCT02397785|141230929|SUPERIORITY|||||||0.3155|||||||t-test, 2 sided|||||||0.3155
70872758|NCT00320411|141230968|SUPERIORITY_OR_OTHER||percentage of participants|17.2||||||95.0|8.6|29.4||||||||29.4|8.6|
70872759|NCT00320411|141230970|SUPERIORITY_OR_OTHER||percentage of participants|32.3||||||95.0|20.0|44.7||||||||44.7|20.0|
70872760|NCT00320411|141230971|SUPERIORITY_OR_OTHER||percentage of participants|22.8||||||95.0|11.6|34.0||||||||34.0|11.6|
70872761|NCT02557646|141230986|SUPERIORITY_OR_OTHER|||||||0.0437|TWO_SIDED||||||Chi-squared|||Cumulative dose of ribavirin \>90%: the relationship between cumulative dose and SVR response in participants in whom the cumulative dose of ribavirin exceeded 90% was analyzed using Chi-square test.||||0.0437
70872762|NCT02557646|141230988|SUPERIORITY_OR_OTHER|||||||0.6859|TWO_SIDED||||||Chi-squared|||The relationship between the starting dose ribavirin and virological response was analyzed using Chi-square test.||||0.6859
70872763|NCT02557646|141230989|SUPERIORITY_OR_OTHER|||||||0.374|TWO_SIDED||||||Chi-squared|||The relationship between the starting dose ribavirin and sustained virological response (SVR) was analyzed using Chi-square test.||||0.3740
70872764|NCT02557646|141230990|SUPERIORITY_OR_OTHER|||||||0.0263|TWO_SIDED||||||Chi-squared, Corrected|||The relationship between the body weight-normalized dose of ribavirin and virological response was analyzed using Chi-square test.||||0.0263
70872765|NCT02557646|141230991|SUPERIORITY_OR_OTHER|||||||0.0475|TWO_SIDED||||||Chi-squared|||The relationship between the body weight-normalized dose of ribavirin and sustained virological (SVR) response was analyzed using Chi-square test.||||0.0475
70872766|NCT02557646|141230997|SUPERIORITY_OR_OTHER|||||||0.1499|TWO_SIDED||||||Chi-squared|||The relationship between the cumulative dose of ribavirin and relapse rate was analyzed using Chi-square test.||||0.1499
70872767|NCT02557646|141230998|SUPERIORITY_OR_OTHER|||||||0.5885|TWO_SIDED||||||Chi-squared|||The relationship between the starting dose of ribavirin and relapse rate was analyzed using Chi-square test.||||0.5885
70872768|NCT02557646|141230999|SUPERIORITY_OR_OTHER|||||||0.0062|TWO_SIDED||||||Chi-squared|||The relationship between the body weight-normalized dose of ribavirin and relapse rate was analyzed using Chi-square test.||||0.0062
71145830|NCT02977403|141785389|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.017|||||TWO_SIDED|95.0|-0.092|0.057||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.057|-0.092|
70872769|NCT03926169|141231078|SUPERIORITY||Adjusted Response Rate Difference (%)|6.0||||0.422|TWO_SIDED|97.5|-10.8|22.8||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||22.8|-10.8|0.422
70872770|NCT03926169|141231078|SUPERIORITY||Adjusted Response Rate Difference (%)|1.3||||0.858|TWO_SIDED|97.5|-15.4|18.1||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||18.1|-15.4|0.858
70872771|NCT03926169|141231079|SUPERIORITY||Adjusted Response Rate Difference (%)|-3.0||||0.725|TWO_SIDED|97.5|-21.8|15.9||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||15.9|-21.8|0.725
70872772|NCT03926169|141231079|SUPERIORITY||Adjusted Response Rate Difference (%)|8.8||||0.301|TWO_SIDED|97.5|-10.3|27.8||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||27.8|-10.3|0.301
70872773|NCT03926169|141231080|SUPERIORITY||Adjusted Response Rate Difference (%)|3.7||||0.65|TWO_SIDED|97.5|-14.5|21.8||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||21.8|-14.5|0.650
70872774|NCT03926169|141231080|SUPERIORITY||Adjusted Response Rate Difference (%)|12.3||||0.147|TWO_SIDED|97.5|-6.7|31.3||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||31.3|-6.7|0.147
70872775|NCT03926169|141231081|SUPERIORITY||Adjusted Response Rate Difference (%)|-6.5||||0.342|TWO_SIDED|97.5|-21.8|8.8||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||8.8|-21.8|0.342
70872776|NCT03926169|141231081|SUPERIORITY||Adjusted Response Rate Difference (%)|-10.6||||0.108|TWO_SIDED|97.5|-25.3|4.2||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||4.2|-25.3|0.108
70872777|NCT03926169|141231082|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.97||0.179|TWO_SIDED|97.5|-3.5|0.9||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.9|-3.5|0.179
70872778|NCT03926169|141231082|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.98||0.105|TWO_SIDED|97.5|-3.8|0.6||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.6|-3.8|0.105
70872779|NCT03926169|141231083|SUPERIORITY||LS Mean Difference|0.118|STANDARD_ERROR_OF_MEAN|0.3385||0.727|TWO_SIDED|97.5|-0.646|0.883||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.883|-0.646|0.727
70872780|NCT03926169|141231083|SUPERIORITY||LS Mean Difference|-0.015|STANDARD_ERROR_OF_MEAN|0.3273||0.963|TWO_SIDED|97.5|-0.755|0.724||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.724|-0.755|0.963
70872781|NCT03926169|141231084|SUPERIORITY||LS Mean Difference|0.042|STANDARD_ERROR_OF_MEAN|0.2941||0.886|TWO_SIDED|97.5|-0.622|0.706||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.706|-0.622|0.886
70872782|NCT03926169|141231084|SUPERIORITY||LS Mean Difference|0.236|STANDARD_ERROR_OF_MEAN|0.2851||0.409|TWO_SIDED|97.5|-0.408|0.879||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.879|-0.408|0.409
70872783|NCT03926169|141231085|SUPERIORITY||LS Mean Difference|-0.252|STANDARD_ERROR_OF_MEAN|0.3212||0.434|TWO_SIDED|97.5|-0.977|0.473||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.473|-0.977|0.434
70872784|NCT03926169|141231085|SUPERIORITY||LS Mean Difference|-0.074|STANDARD_ERROR_OF_MEAN|0.3123||0.813|TWO_SIDED|97.5|-0.779|0.631||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.631|-0.779|0.813
70872785|NCT04774328|141231121|OTHER|Analysis of Variance (ANOVA)|Median Difference (Final Values)|-39.28|STANDARD_ERROR_OF_MEAN|54.818||0.4812|TWO_SIDED|95.0|-152.97|74.4|||ANOVA|||||74.40|-152.97|0.4812
70872786|NCT04774328|141231122|OTHER|ANOVA|Mean Difference (Final Values)|-158.08|STANDARD_ERROR_OF_MEAN|64.232||0.0222|TWO_SIDED|95.0|-291.29|-24.87|||ANOVA|||"Applies to evoked measure of after coughing."||-24.87|-291.29|0.0222
70872787|NCT04774328|141231122|OTHER|ANOVA|Mean Difference (Final Values)|-55.04|STANDARD_ERROR_OF_MEAN|43.19||0.2158|TWO_SIDED|95.0|-144.61|34.53|||ANOVA|||"Applies to evoked measure for after sitting up."||34.53|-144.61|0.2158
70872788|NCT04774328|141231122|OTHER|ANOVA|Mean Difference (Final Values)|-78.73|STANDARD_ERROR_OF_MEAN|42.532||0.0777|TWO_SIDED|95.0|-166.93|9.48|||ANOVA|||"Applies to evoked measure of after ambulation."||9.48|-166.93|0.0777
70872789|NCT04774328|141231123|OTHER|ANOVA|Mean Difference (Final Values)|-9.375|STANDARD_ERROR_OF_MEAN|12.7245||0.469|TWO_SIDED|95.0|-35.764|17.014|||ANOVA|||Entry applies to OC 0-96 hours.||17.014|-35.764|0.4690
70872790|NCT04774328|141231123|OTHER|ANOVA|Mean Difference (Final Values)|-8.125|STANDARD_ERROR_OF_MEAN|14.5059||0.5811|TWO_SIDED|95.0|-38.208|21.958|||ANOVA|||Applies to OC 0 - Day 8.||21.958|-38.208|0.5811
71145831|NCT02977403|141785389|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|0.002|||||TWO_SIDED|95.0|-0.15|0.153||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.153|-0.150|
71145832|NCT02977403|141785390|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.07|||||TWO_SIDED|95.0|-0.019|0.159||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.159|-0.019|
71145833|NCT02977403|141785390|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.095|||||TWO_SIDED|95.0|-0.26|0.07||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.070|-0.260|
71145834|NCT02977403|141785391|SUPERIORITY||beta coefficient|-0.8707|STANDARD_ERROR_OF_MEAN|0.766||0.256|TWO_SIDED||||||Generalized estimation equations||Reported variable is a condition by time (pre or post-intervention) interaction term. The model included a Poisson distribution, log link function, exchangeable covariance matrix and was adjusted for age, fat mass, height, and race and ethnicity.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||||0.256
71145835|NCT02994108|141785415|SUPERIORITY||Chi-Square|0.415||||0.601|TWO_SIDED||||||Chi-squared|||||||.601
71145836|NCT02994108|141785416|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.249|TWO_SIDED||||||t-test, 2 sided|||||||.249
71145837|NCT02994108|141785417|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.675|TWO_SIDED||||||t-test, 2 sided|||||||.675
71145838|NCT02994108|141785418|SUPERIORITY||Odds Ratio (OR)|3.43||||0.025|TWO_SIDED|95.0|1.17|10.08|||Regression, Logistic|||||10.08|1.17|.025
71145839|NCT02994108|141785419|SUPERIORITY||Odds Ratio (OR)|1.14||||0.923|TWO_SIDED|95.0|0.08|16.95|||Regression, Logistic|||||16.95|0.08|.923
71145840|NCT02994108|141785420|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.174|TWO_SIDED||||||t-test, 2 sided|||||||.174
71145841|NCT02994108|141785421|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.002|TWO_SIDED||||||t-test, 2 sided|||||||.002
71145842|NCT02994108|141785422|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.964|TWO_SIDED||||||t-test, 2 sided|||||||.964
71145843|NCT02994108|141785423|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.053|TWO_SIDED||||||t-test, 2 sided|||||||.053
71145844|NCT02994108|141785424|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.183|TWO_SIDED||||||t-test, 2 sided|||||||.183
71145845|NCT02994108|141785425|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.064|TWO_SIDED||||||t-test, 2 sided|||||||.064
71145846|NCT02994108|141785426|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.147|TWO_SIDED||||||t-test, 2 sided|||||||.147
71145847|NCT02994108|141785427|SUPERIORITY||Mean Difference (Final Values)|-0.29||||0.096|TWO_SIDED||||||t-test, 2 sided|||||||.096
71145848|NCT02994108|141785428|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.013|TWO_SIDED||||||t-test, 2 sided|||||||.013
71145849|NCT00781768|141785429|SUPERIORITY||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED||||||Chi-squared|||The null hypothesis is that there will be a higher proportion of complete responders among those subjects receiving the combination therapy.||||<.001
71145850|NCT04567628|141785432|OTHER||||||=|0.003|||||||Spearman's Rank Correlation|||||||=0.003
71145851|NCT04567628|141785433|OTHER||||||=|0.25||||||A two-sided p-value of \<0.05 was considered statistically significant.|Log Rank|||||||=0.25
71145852|NCT04567628|141785436|OTHER||||||<|0.001||||||A two-sided p-value of \<0.05 was considered statistically significant.|Log Rank|||||||<0.001
71145853|NCT04567628|141785438|OTHER||||||<|0.0001||||||A two-sided p-value of \<0.05 was considered statistically significant.|Log Rank|||||||<0.0001
71145854|NCT02458313|141785444|SUPERIORITY|DMXB-A vs. Placebo groups compared at baseline||||||0.647|||||||t-test, 2 sided|||||||0.647
71145855|NCT02458313|141785444|SUPERIORITY|||||||0.679|||||||t-test, 2 sided|||DMXB-A vs. Placebo groups compared post-intervention||||0.679
71145856|NCT02458313|141785445|SUPERIORITY|||||||0.951|||||||t-test, 2 sided|||DMXB-A vs. Placebo groups compared at baseline||||0.951
71145857|NCT02458313|141785445|SUPERIORITY|||||||0.884|||||||t-test, 2 sided|||DMXB-A vs. Placebo groups compared post-intervention||||0.884
71145858|NCT01097668|141785501|SUPERIORITY_OR_OTHER||||||<|0.001|||||||negative binomial model|||Comparison of the baseline 'ITT population' MRI data with week 16 data.||||<0.001
71145859|NCT01097668|141785501|SUPERIORITY_OR_OTHER|||||||0.03|||||||negative binomial model|||Comparison of the baseline 'MRI population' data with data from week 16.||||0.030
71145860|NCT00385671|141785526|NON_INFERIORITY_OR_EQUIVALENCE|Basis of non-inferiority margin (maximum disadvantage for duloxetine compared to pregabalin not considered meaningful): In 3 previous placebo-controlled trials of duloxetine in DPNP, in the subgroup of patients that had been treated with gabapentin prior to entry, the estimated mean change in pain at Week 12 was -2.74 for duloxetine and -1.09 for placebo, an advantage of about 1.65. The non-inferiority margin represents about half of this previous treatment effect in a similar population.|Mean Difference (Final Values)|0.49||||0.076|TWO_SIDED|95.0|-0.05|1.04||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week, Kenward-Roger approximation was used.||Null hypothesis: no difference in mean change from baseline to 12 weeks in weekly mean of daily 24 hour average pain score between pregabalin \& duloxetine treatments. Sample size: 125 participants/treatment, 6% increase for 400 planned enrollees. 92% power with 1-sided 97.5% confidence interval; mean change in duloxetine group, -2.7; in pregabalin group, -2.5; standard deviation, 2.3; margin of non-inferiority: -0.8.||1.04|-0.05|0.076
71145861|NCT00385671|141785527|NON_INFERIORITY_OR_EQUIVALENCE|Basis of non-inferiority margin (maximum disadvantage for duloxetine compared to pregabalin not considered meaningful): In 3 previous placebo-controlled trials of duloxetine in DPNP, in the subgroup of patients that had been treated with gabapentin prior to entry, the estimated mean change in pain at Week 12 was -2.74 for duloxetine and -1.09 for placebo, an advantage of about 1.65. The non-inferiority margin represents about half of this previous treatment effect in a similar population.|Mean Difference (Final Values)|0.23||||0.417|TWO_SIDED|95.0|-0.32|0.78||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week, Kenward-Roger approximation was used.||Null hypothesis: no difference in mean change from baseline to 12 weeks in weekly mean of daily 24 hour average pain score between duloxetine \& duloxetine+gabapentin treatments. Sample size: 125 participants/treatment, 6% increase for 400 planned enrollees. 92% power with 1-sided 97.5% confidence interval; mean change in duloxetine group, -2.7; in pregabalin group, -2.5; standard deviation, 2.3; margin of non-inferiority: -0.8.||0.78|-0.32|0.417
71145862|NCT00385671|141785528|SUPERIORITY_OR_OTHER|||||||0.463||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Weekly mean of nighttime pain severity.||||0.463
71145863|NCT00385671|141785528|SUPERIORITY_OR_OTHER|||||||0.52||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean of nighttime pain severity.||||0.520
71145864|NCT00385671|141785528|SUPERIORITY_OR_OTHER|||||||0.463||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean of nighttime pain severity.||||0.463
70872827|NCT02846779|141231172|SUPERIORITY||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.75|1.03||||||||1.03|0.75|
70872828|NCT02846779|141231172|SUPERIORITY||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.77|1.06||||||||1.06|0.77|
70872829|NCT02846779|141231173|SUPERIORITY||Risk Difference (RD)|-0.15|||||TWO_SIDED|95.0|-0.34|0.05||||||||0.05|-0.34|
70872830|NCT02846779|141231173|SUPERIORITY||Risk Difference (RD)|-0.25|||||TWO_SIDED|95.0|-0.43|-0.06||||||||-0.06|-0.43|
70872831|NCT02846779|141231174|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.95|1.11||||||||1.11|0.95|
70872832|NCT02846779|141231174|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.92|1.06||||||||1.06|0.92|
70872833|NCT02846779|141231175|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.97|1.02||||||||1.02|0.97|
70872834|NCT02846779|141231175|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.96|1.0||||||||1.00|0.96|
70872835|NCT02846779|141231176|SUPERIORITY||Risk Ratio (RR)|1.38|||||TWO_SIDED|95.0|1.24|1.53||||||||1.53|1.24|
70872836|NCT02846779|141231176|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.85|1.07||||||||1.07|0.85|
70872837|NCT02846779|141231177|SUPERIORITY||Risk Ratio (RR)|1.22|||||TWO_SIDED|95.0|1.06|1.41||||||||1.41|1.06|
70872838|NCT02846779|141231177|SUPERIORITY||Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.99|1.32||||||||1.32|0.99|
70872839|NCT00040937|141231179|SUPERIORITY_OR_OTHER||4-yr survival (%)|64.0|||||TWO_SIDED|95.0|55.0|74.0|||Kaplan and Meier|||The study was designed to have 82% power for detecting a 50% improvement in survival from a median of 4 years, as observed in SWOG S9321.||74|55|
70872840|NCT02016560|141231208|OTHER||Cox Proportional Hazard|1.581||||0.067|TWO_SIDED|95.0|0.968|2.581||A p-value of \<0.05 was the a priori threshold for statistical significance.|Cox proportional hazards|The Cox proportional hazard model was adjusted for baseline age, American National Adult Reading Test (ANART) score, and baseline CDR-SB score.||The specific hypothesis tested was that the hazard of progressing to the clinically meaningful event (defined as CDR-SB value change of at least 1 within 18 months) will be significantly greater for subjects with flortaucipir scans rated by majority interpretation as predicted to progress (Advanced AD scan pattern), as compared to subjects with scans rated as not predicted to progress (Moderate or Not AD scan pattern).||2.581|0.968|0.067
70872841|NCT02016560|141231209|OTHER||||||<|0.0001||||||No adjustment for multiple comparisons. No a priori threshold was set.|ANCOVA|Adjusted for age||ANCOVA model comparing the mean SUVr between AD and Older Cognitively Healthy within amyloid positive group.||||<0.0001
70872842|NCT02016560|141231209|OTHER|||||||0.0622||||||No adjustment for multiple comparisons. No a priori threshold was set.|ANCOVA|Adjusted for age||ANCOVA model comparing the mean SUVr between MCI and Older Cognitively Healthy within the amyloid positive group.||||0.0622
70872843|NCT02016560|141231209|OTHER||||||<|0.0001||||||No adjustment for multiple comparisons. No a priori threshold was set.|ANCOVA|Adjusted for age||ANCOVA model comparing the mean SUVr between AD and MCI within the amyloid positive group.||||<0.0001
70872844|NCT02016560|141231210|EQUIVALENCE|Test of whether the least squares mean change is significantly different than zero|||||<|0.0001|||||||Mixed Models Analysis|||SUVr change from baseline as dependent variable, baseline SUVr, age, and visit as independent variables, using an unstructured covariance structure for amyloid positive subjects only.||||<0.0001
70872845|NCT02016560|141231210|EQUIVALENCE|Test of whether the least squares mean change is significantly different than zero||||||0.7851|||||||Mixed Models Analysis|||SUVr change from baseline as dependent variable, baseline SUVr, age, and visit as independent variables, using an unstructured covariance structure for amyloid negative subjects only.||||0.7851
70872846|NCT02016560|141231211|OTHER||||||||||||||||||The hypothesis tested was that, of the 5 independent imaging physicians, at least 3 will have the lower bounds of 2-sided 95% confidence intervals ≥50%, for both sensitivity and specificity.|||
70872847|NCT02016560|141231212|OTHER||Pearson's correlation coefficient|-0.0925||||0.4361|TWO_SIDED||||||Pearson|||Pearson's correlation coefficient||||0.4361
70872848|NCT01852110|141231221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.7623|TWO_SIDED|95.0|-1.0|1.37|||Constrained Longitudinal Data Analysis|||||1.37|-1.00|0.7623
70872849|NCT01852110|141231225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.9604|TWO_SIDED|95.0|-2.42|2.54|||Constrained Longitudinal Data Analysis|||||2.54|-2.42|0.9604
71145865|NCT00385671|141785529|SUPERIORITY_OR_OTHER|||||||0.389||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in weekly mean of the daily worst pain severity score.||||0.389
70872850|NCT01852110|141231226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.0829|TWO_SIDED|95.0|-0.01|0.22|||Constrained Longitudinal Data Analysis|||||0.22|-0.01|0.0829
70872851|NCT00759031|141231228|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70872852|NCT04180488|141231243|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-4.23||||0.0005|TWO_SIDED|95.0|-6.63|-1.84||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an analysis of covariance (ANCOVA) model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-1.84|-6.63|0.0005
70872853|NCT04180488|141231243|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-2.87||||0.0449|TWO_SIDED|95.0|-5.68|-0.07||Threshold for significance at 2-sided 0.043 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-0.07|-5.68|0.0449
70872854|NCT04180488|141231243|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-2.54||||0.0184|TWO_SIDED|95.0|-4.65|-0.43||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-0.43|-4.65|0.0184
70872855|NCT04180488|141231244|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-8.53||||0.0003|TWO_SIDED|95.0|-13.16|-3.9||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-3.90|-13.16|0.0003
70872856|NCT04180488|141231244|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-4.65||||0.0226|TWO_SIDED|95.0|-8.65|-0.65||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-0.65|-8.65|0.0226
70872857|NCT04180488|141231245|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-4.38||||0.0003|TWO_SIDED|95.0|-6.78|-1.98||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-1.98|-6.78|0.0003
70872858|NCT04180488|141231245|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-2.17||||0.0316|TWO_SIDED|95.0|-4.15|-0.19||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-0.19|-4.15|0.0316
70872859|NCT04180488|141231246|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|3.413||||0.0014|TWO_SIDED|95.0|1.596|7.299||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel (CMH) test was performed on association between responder status and intervention group, adjusted by baseline disease severity (UAS7\<28,\>=28), presence of angioedema at baseline and region.||7.299|1.596|0.0014
71145866|NCT00385671|141785529|SUPERIORITY_OR_OTHER|||||||0.126||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in weekly mean of the daily worst pain severity score.||||0.126
71145867|NCT00385671|141785529|SUPERIORITY_OR_OTHER|||||||0.489||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in weekly mean of the daily worst pain severity score.||||0.489
71145868|NCT00385671|141785530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.602|TWO_SIDED|95.0|-0.2|0.35||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Covariance model and t-tests: Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in CGI severity.||0.35|-0.20|0.602
71145869|NCT00385671|141785530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.469|TWO_SIDED|95.0|-0.17|0.37||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in CGI severity.||0.37|-0.17|0.469
71145870|NCT00385671|141785530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.841|TWO_SIDED|95.0|-0.24|0.3||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in CGI severity.||0.30|-0.24|0.841
71145871|NCT00385671|141785531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.276|TWO_SIDED|95.0|-0.16|0.55||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Variance model and t-tests:~Endpoint = InvestigatorGroup + Treatment. Last-observation-carried-forward imputation was implemented."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in PGI-Improvement at 12 weeks.||0.55|-0.16|0.276
71145872|NCT00385671|141785531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.929|TWO_SIDED|95.0|-0.33|0.37||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Variance model and t-tests:~Endpoint = InvestigatorGroup + Treatment. Last-observation-carried-forward imputation was implemented."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in PGI-Improvement at 12 weeks.||0.37|-0.33|0.929
71145873|NCT00385671|141785531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.313|TWO_SIDED|95.0|-0.53|0.17||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Variance model and t-tests:~Endpoint = InvestigatorGroup + Treatment. Last-observation-carried-forward imputation was implemented."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in PGI-Improvement at 12 weeks.||0.17|-0.53|0.313
70872860|NCT04180488|141231246|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|2.507||||0.0109|TWO_SIDED|95.0|1.231|5.107||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||5.107|1.231|0.0109
70872861|NCT04180488|141231247|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|2.848||||0.0075|TWO_SIDED|95.0|1.301|6.234||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||6.234|1.301|0.0075
71145874|NCT00385671|141785532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49||||0.078|TWO_SIDED|95.0|-0.06|1.04||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: 24-hour average pain.||1.04|-0.06|0.078
71145875|NCT00385671|141785532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64||||0.025|TWO_SIDED|95.0|0.08|1.2||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: 24-hour average pain.||1.20|0.08|0.025
70872862|NCT04180488|141231247|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|3.137||||0.0045|TWO_SIDED|95.0|1.371|7.176||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||7.176|1.371|0.0045
70872863|NCT04180488|141231248|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|2.908||||0.0199|TWO_SIDED|95.0|1.173|7.209||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||7.209|1.173|0.0199
70872864|NCT04180488|141231248|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|2.677||||0.0187|TWO_SIDED|95.0|1.127|6.359||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||6.359|1.127|0.0187
70872865|NCT04180488|141231249|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|0.93||||0.194|TWO_SIDED|95.0|-0.48|2.34||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||2.34|-0.48|0.1940
70872866|NCT04180488|141231250|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-2.37||||0.0377|TWO_SIDED|95.0|-4.6|-0.13||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-0.13|-4.60|0.0377
70872867|NCT04180488|141231251|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-5.02||||0.0223|TWO_SIDED|95.0|-9.32|-0.72||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-0.72|-9.32|0.0223
70872868|NCT04180488|141231252|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|2.645||||0.0215|TWO_SIDED|95.0|1.154|6.061||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||6.061|1.154|0.0215
70872869|NCT04180488|141231253|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|1.872||||0.0971|TWO_SIDED|95.0|0.893|3.923||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||3.923|0.893|0.0971
70872870|NCT01104493|141231299|NON_INFERIORITY_OR_EQUIVALENCE|H0 (null): Rate difference ≥ 5 percentage points This corresponded to a null hypothesis of: HA (alternative): rate difference \< 5 percentage points.|rate difference|0.4|||||TWO_SIDED|95.0|-5.2|2.6|||score statistic|||Comparison of the rate of fever between the 2 treatment groups was based on the upper limit of the two-sided 95% exact confidence intervals (CIs) for the rate increase (Monovalent vaccine minus Placebo) evaluated against the prespecified equivalence criterion of 5 percentage points.||2.6|-5.2|
70872871|NCT00208091|141231306|SUPERIORITY_OR_OTHER||||||=|0.06||95.0|||||Wilcoxon (Mann-Whitney)|||||||=0.06
70872872|NCT00208091|141231307|SUPERIORITY_OR_OTHER||||||=|0.23||95.0|||||Wilcoxon (Mann-Whitney)|||||||=0.23
70872873|NCT01599234|141231314|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.23||||0.22||95.0|-0.59|0.14|||ANCOVA|||The initial model used for the analysis of the end of study value was an analysis of covariance (ANCOVA) with baseline as a covariate and treatment group, centre group, ambulatory status at baseline and previous use of cannabis as main effects. Interactions between the main effects were investigated, and if they had little influence then they were dropped from the model. These tests were performed at the 10% significance level as a possible indicator of an interactive effect.||0.14|-0.59|0.220
70872874|NCT01599234|141231315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.341||||0.231|TWO_SIDED|95.0|0.83|2.167|||ANCOVA|||The numbers of responders was analysed using the difference in proportions and the odds ratio comparing the treatment groups with the provision of 95% CIs for the difference and odds ratio. The two groups were compared using ANCOVA with baseline severity as a covariate and study centre and treatment group as factors.||2.167|0.830|0.231
70872875|NCT01599234|141231316|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.16||||0.857|TWO_SIDED|95.0|-1.94|1.61|||ANCOVA|||The change at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment, centre group and ambulatory status at baseline as factors and baseline score as a covariate.||1.61|-1.94|0.857
70872876|NCT01599234|141231317|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.07||||0.734|TWO_SIDED|95.0|-0.55|0.4|||ANCOVA|||The two groups were compared using ANCOVA with baseline severity as a covariate and study centre and treatment group as factors.||0.40|-0.55|0.734
70872877|NCT01599234|141231319|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.0||||0.624|TWO_SIDED|95.0|-2.0|1.0|||ANCOVA|||The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment, centre group and ambulatory status at baseline as factors and baseline score as a covariate.||1.0|-2.0|0.624
70872878|NCT01599234|141231320|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.248||||0.27|TWO_SIDED|95.0|0.842|1.849|||Regression, Logistic|||The two treatment groups were to be compared using ordinal logistic regression and the proportional odds model. The model was to incorporate ambulatory status at baseline and centre group.||1.849|0.842|0.270
70872879|NCT01599234|141231321|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.15||||0.867|TWO_SIDED|95.0|-1.95|1.64|||ANCOVA|||The change at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment, centre group and ambulatory status at baseline as factors and baseline score as a covariate.||1.64|-1.95|0.867
70872880|NCT01599234|141231322|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.215||||0.569|TWO_SIDED|95.0|0.622|2.373|||ANCOVA|||The numbers of responders was analysed using the difference in proportions and the odds ratio comparing the treatment groups with the provision of 95% CIs for the difference and odds ratio. The two groups were compared using ANCOVA with baseline severity as a covariate and study centre and treatment group as factors.||2.373|0.622|0.569
70872881|NCT04626297|141231349|OTHER||Risk Difference (RD)|0.3|||||TWO_SIDED|90.0|-10.2|11.2||||||||11.2|-10.2|
70872882|NCT04626297|141231350|OTHER||Risk Difference (RD)|12.2|||||TWO_SIDED|90.0|2.5|22.0||||||||22.0|2.5|
70872883|NCT04626297|141231351|OTHER||Risk Difference (RD)|21.7|||<|0.001|TWO_SIDED|95.0|10.3|33.2|||Cochran-Mantel-Haenszel|||||33.2|10.3|<0.001
70872884|NCT04626297|141231352|OTHER||Risk Difference (RD)|25.3|||<|0.001|TWO_SIDED|95.0|12.6|38.0|||Cochran-Mantel-Haenszel|||||38|12.6|<0.001
70872885|NCT04626297|141231353|OTHER||Risk Difference (RD)|20.3|||<|0.001|TWO_SIDED|95.0|9.0|31.6|||Cochran-Mantel-Haenszel|||||31.6|9.0|<0.001
70872886|NCT04626297|141231354|OTHER||Risk Difference (RD)|11.9||||0.138|TWO_SIDED|95.0|-3.8|27.5|||Cochran-Mantel-Haenszel|||||27.5|-3.8|0.138
70872887|NCT04626297|141231355|OTHER||LS Mean Difference|-8.21|STANDARD_ERROR_OF_MEAN|2.447|<|0.001|TWO_SIDED|95.0|-13.04|-3.39|||Mixed Models Analysis||The mixed model repeated measures (MMRM) included treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit, geographic region, age group, baseline IGA score as fixed factors.|||-3.39|-13.04|<0.001
70872888|NCT04626297|141231356|OTHER||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.152||0.001658|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|||||-0.2|-0.8|0.001658
70872889|NCT03167411|141231357|EQUIVALENCE|The ratio of the least squares (LS) geometric means of Cmax when bexagliflozin is dosed in combination with exenatide versus when dosed alone, with 80-125% defined as the lack of interaction boundaries. 90% confidence intervals was constructed.|Point Estimate (%)|125.27|||||TWO_SIDED|90.0|104.45|150.24|||||Estimated ratio (%) of exponentiated mean difference of log-transformed PK parameter from ANOVA (linear mixed-effects model), with treatment, period, and sequence as fixed effects, and subject as a random effect.|||150.24|104.45|
70872890|NCT03167411|141231360|EQUIVALENCE|The ratio of the least squares (LS) geometric means of AUC0-inf when bexagliflozin is dosed in combination with exenatide versus when dosed alone, with 80-125% defined as the lack of interaction boundaries. 90% confidence intervals was constructed.|Point Estimate (%)|137.56|||||TWO_SIDED|90.0|122.28|154.75|||||Estimated ratio (%) of exponentiated mean difference of log-transformed PK parameter from ANOVA (linear mixed-effects model), with treatment, period, and sequence as fixed effects, and subject as a random effect.|||154.75|122.28|
70872891|NCT02602496|141231362|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.9942||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.9942
70872892|NCT02602496|141231362|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.0062|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.0062
70872893|NCT02602496|141231362|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.6843|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.6843
70872894|NCT02602496|141231363|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.5096||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.5096
70872895|NCT02602496|141231363|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.2276|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.2276
70872896|NCT02602496|141231363|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.0006|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.0006
70872897|NCT02602496|141231364|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.9708||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.9708
70872898|NCT02602496|141231364|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.1642|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.1642
70872899|NCT02602496|141231364|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.6043|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.6043
70872900|NCT02602496|141231365|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.0868||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.0868
70872901|NCT02602496|141231365|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.0083|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.0083
71145876|NCT00385671|141785532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.602|TWO_SIDED|95.0|-0.41|0.7||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: 24-hour average pain.||0.70|-0.41|0.602
70872902|NCT02602496|141231365|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.0151|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.0151
70954532|NCT04150068|141412044|SUPERIORITY|The difference in percentage between 2 treatment groups was compared using an unconditional exact method using 2 invert 1-sided tests with an alpha level at 0.05 to evaluate superiority.|Percentage Difference|70.8|||<|0.0001|TWO_SIDED|95.0|34.9|90.0||The P value and 95% confidence interval (CI) for the point estimate of treatment difference in proportions was estimated and constructed using the Chan and Zhang method.|Chan & Zhang method|||||90.0|34.9|< 0.0001
70954533|NCT05316701|141412053|SUPERIORITY||Hazard Ratio (HR)|0.26|||<|1e-05|TWO_SIDED|95.0|0.14|0.47|||Log Rank|||Log-rank test was stratified by randomization stratification factors.||0.47|0.14|<0.00001
70954534|NCT05316701|141412054|SUPERIORITY||Hazard Ratio (HR)|0.19||||2e-05|TWO_SIDED|95.0|0.08|0.43|||Gray's test|||Gray's test was stratified by randomization stratification factors.||0.43|0.08|0.00002
70954535|NCT05316701|141412055|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.11823|TWO_SIDED|95.0|0.2|1.22|||Log Rank|||Log-rank test was stratified by randomization stratification factors.||1.22|0.20|0.11823
70954536|NCT05316701|141412056|SUPERIORITY||Hazard Ratio (HR)|0.37||||3e-05|TWO_SIDED|95.0|0.23|0.6|||Log Rank|||Log-rank test was stratified by randomization stratification factors.||0.60|0.23|0.00003
70954537|NCT04696653|141412057|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.2|0.1||||||||0.1|-0.2|
70954538|NCT04696653|141412058|SUPERIORITY||Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|0.2|1.8||||||hypertension||1.8|0.2|
70954539|NCT04696653|141412058|SUPERIORITY||Mean Difference (Net)|1.1|||||TWO_SIDED|95.0|0.0|2.1||||||dyslipidemia||2.1|0.0|
70954540|NCT04696653|141412058|SUPERIORITY||Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|0.1|2.0||||||diabetes||2.0|0.1|
70872903|NCT02602496|141231366|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.9255||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.9255
70872904|NCT02602496|141231366|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.0454|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.0454
70872905|NCT02602496|141231366|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.292|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.2920
70954541|NCT04696653|141412059|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.6|0.1||||||Evidenced based practice||0.1|-0.6|
70954542|NCT04696653|141412059|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.6|0.1||||||CUSP strategy||0.1|-0.6|
70954543|NCT04696653|141412060|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.6|0.2||||||CUSP strategy||0.2|-0.6|
70954544|NCT04696653|141412060|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.5|0.1||||||Evidenced based practice||0.1|-0.5|
70954545|NCT04696653|141412061|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.5|0.1||||||evidenced based practice||0.1|-0.5|
70954546|NCT04696653|141412061|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.5|0.2||||||CUSP strategy||0.2|-0.5|
70954547|NCT04696653|141412062|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.9|2.2||||||||2.2|0.9|
70954548|NCT04696653|141412063|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|1.1|1.9||||||||1.9|1.1|
70954549|NCT04696653|141412064|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.7|1.4||||||||1.4|0.7|
70954550|NCT04696653|141412065|SUPERIORITY||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|1.2|2.6||||||||2.6|1.2|
70954551|NCT04696653|141412070|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|1.0|1.6||||||||1.6|1.0|
70954552|NCT04696653|141412071|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.2|0.1||||||||0.1|-0.2|
70954553|NCT04696653|141412072|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.2|0.2||||||||0.2|-0.2|
70954554|NCT04696653|141412073|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.2|0.1||||||||0.1|-0.2|
70954555|NCT04696653|141412074|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.2|0.2||||||||0.2|-0.2|
70954556|NCT04696653|141412075|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.3|0.0||||||||0.0|-0.3|
70954557|NCT04696653|141412076|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.3|0.0||||||||0.0|-0.3|
70954558|NCT04696653|141412077|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.1|0.3||||||||0.3|-0.1|
70954559|NCT04696653|141412078|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||||0.2|-0.1|
70954560|NCT04696653|141412079|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.2|0.2||||||||0.2|-0.2|
70954561|NCT04696653|141412080|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.4|0.0||||||||0.0|-0.4|
70954562|NCT04696653|141412081|SUPERIORITY||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|1.0|3.3||||||||3.3|1.0|
70872906|NCT02602496|141231367|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.2252||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.2252
70872907|NCT02602496|141231367|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.4715|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.4715
70872908|NCT02602496|141231367|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.7157|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.7157
70872909|NCT02602496|141231368|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.8323||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.8323
70872910|NCT02602496|141231368|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.8927|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.8927
70872911|NCT02602496|141231368|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.3173|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.3173
70872912|NCT02602496|141231369|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.27||||||Corrected for baseline concentrations, age and gender|ANOVA|||||||0.27
70872913|NCT00729651|141231384|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.02|||<|0.0001||95.0|0.0|0.08|||Cochran-Mantel-Haenszel|Primary efficacy endpoint was analyzed by a Cochran-Mantel-Haenszel test with baseline vitamin D level as covariate.|Mantel-Haenszel estimator of the common odds ratio was calculated by using Cochran-Mantel-Haenszel test for subjects' proportions with vitamin D deficiency changes at 16 weeks (visit 4) from baseline (visit 1) between treatment groups.|||0.08|0.00|<0.0001
70872914|NCT00729651|141231385|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0091||95.0|||||ANCOVA|Least squares mean is mean of serum PTH percentage changes adjusted serum PTH level at baseline.||||||0.0091
70872915|NCT00729651|141231386|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.02|||<|0.0001||95.0|0.01|0.04|||Cochran-Mantel-Haenszel|It was analyzed by a Cochran-Mantel-Haenszel test with baseline vitamin D level as covariate.|Mantel-Haenszel estimator of the common odds ratio was calculated by using Cochran-Mantel-Haenszel test for subjects' proportions with vitamin D deficiency changes at 16 weeks (visit 4) from baseline (visit 1) between treatment groups.|||0.04|0.01|<0.0001
70872916|NCT00545662|141231388|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.76|TWO_SIDED|95.0|0.83|1.14||a priori threshold for statistical significance is 0.05|Regression, Logistic|Logistic regression estimated global OR. GEE accounted for correlations of the scales. Models adjusted for site \& injury severity.|The odds in the citicoline group were compared to the odds in the placebo group.|"Null hypothesis: The placebo and citicoline groups do not differ at 90-days on the Core Battery~Power:~1. Two sided type I error of 0.05~2. 85% power~3. Expected OR=1.40 for the global statistic~4. Response rate in the control group~5. Correlations among the nine measures were accounted for. Response rates for the whole sample were a weighted average of the rates provided by TBI severity.~1240 participants were required to detect an OR \>= 1.4 for the global statistic."||1.14|0.83|0.76
70872917|NCT02984709|141231392|SUPERIORITY||Estimated Mean Difference|-0.17||||0.593|TWO_SIDED|95.0|-0.81|0.47||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||||0.47|-0.81|0.593
71145877|NCT00385671|141785533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.353|TWO_SIDED|95.0|-0.34|0.94||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-severity: worst pain.||0.94|-0.34|0.353
70872918|NCT02984709|141231393|SUPERIORITY||Estimated Mean Difference|-1.137||||0.581|TWO_SIDED|95.0|-5.27|2.99||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||||2.99|-5.27|0.581
70872919|NCT02984709|141231394|SUPERIORITY||Estimated Mean Difference|-0.587||||0.206|TWO_SIDED|95.0|-1.52|0.34||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||||0.34|-1.52|0.206
70872920|NCT02984709|141231395|SUPERIORITY||Estimated Mean Difference|-2.494||||0.511|TWO_SIDED|95.0|-10.11|5.13||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||Child-reported family conflict||5.13|-10.11|0.511
70872921|NCT02984709|141231395|SUPERIORITY||Estimated Mean Difference|-3.354||||0.19|TWO_SIDED|95.0|-8.44|1.73||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||Parent-reported family conflict||1.73|-8.44|0.190
70872922|NCT02984709|141231396|SUPERIORITY||Estimated Mean Difference|0.396||||0.873|TWO_SIDED|95.0|-4.57|5.36||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||||5.36|-4.57|0.873
70872923|NCT02984709|141231397|SUPERIORITY||Estimated Mean Difference|2.996||||0.603|TWO_SIDED|95.0|-8.57|14.56||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||||14.56|-8.57|0.603
70872924|NCT02854631|141231422|SUPERIORITY|||||||1|||||||Fisher Exact|P-value from 2-sided Fisher's exact test was used to explore differences between treatment groups in the percentage of participants with an event.||||||1.00
70872925|NCT02854631|141231423|SUPERIORITY|||||||0.061|||||||Fisher Exact|P-value from 2-sided Fisher's exact test was used to explore differences between treatment groups in the percentage of participants with an event.||||||0.061
70872926|NCT02854631|141231424|SUPERIORITY|||||||0.06|||||||Fisher Exact|P-value from 2-sided Fisher's exact test was used to explore differences between treatment groups in the percentage of participants with an event.||||||0.060
70872927|NCT02854631|141231425|SUPERIORITY|||||||0.22||||||P-value from 2-sided Fisher's exact test was used to explore differences between treatment groups in the percentage of participants with an event.|Fisher Exact|||||||0.22
70872928|NCT02854631|141231441|SUPERIORITY|||||||0.3|||||||Fisher Exact|Fisher's exact test (2-sided) was used to explore differences between groups in the percentage of participants with response/non-response.||||||0.30
70872929|NCT01482884|141231469|SUPERIORITY_OR_OTHER||Risk Difference (RD)|4.8||||0.4062|TWO_SIDED|95.0|-13.0|22.5||Glucocorticosteroid-refractory status as stratification factor|Cochran-Mantel-Haenszel|||The null hypothesis is that the proportion of participants responding on tralokinumab is less than or equal to the proportion of participants responding on placebo.||22.5|-13.0|0.4062
70872930|NCT01482884|141231470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.57||0.3937|TWO_SIDED|95.0|-1.63|0.65|||ANCOVA|Mayo score at baseline as a covariate, and treatment and glucocorticosteroid-refractory status as factors in the model.||||0.65|-1.63|0.3937
70872931|NCT01482884|141231471|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.1||||0.1043|TWO_SIDED|95.0|-4.0|28.3||Glucocorticosteroid-refractory status as stratification factor|Cochran-Mantel-Haenszel|||||28.3|-4.0|0.1043
70872932|NCT01482884|141231472|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.4||||0.0326|TWO_SIDED|95.0|0.7|24.1||Glucocorticosteroid-refractory status as stratification factor|Cochran-Mantel-Haenszel|||||24.1|0.7|0.0326
70872933|NCT01482884|141231474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.33||0.449|TWO_SIDED|95.0|-0.41|0.91|||ANCOVA|Modified Riley score at baseline as a covariate, and treatment as factors in the model.||||0.91|-0.41|0.4490
70872934|NCT04216329|141231487|OTHER|||||||0.02|||||||Students t-test|||||||0.02
70872935|NCT04216329|141231487|OTHER|||||||0.07||||||P-value 0.07 represents the difference between baseline depression scores and completion of treatment scores.|Students t-test|||||||0.07
70872936|NCT04216329|141231487|OTHER|||||||0.02|||||||Students t-test|||||||0.02
70872937|NCT04216329|141231487|OTHER|||||||0.07||||||P-value 0.07 represents the difference between baseline depression scores and completion of treatment scores.|Students t-test|||||||0.07
70872938|NCT04216329|141231487|OTHER|||||||0.02|||||||Students t-test|||||||0.02
70872939|NCT04216329|141231487|OTHER|||||||0.07||||||P-value 0.07 represents the difference between baseline depression scores and completion of treatment scores.|Students t-test|||||||0.07
70872940|NCT04216329|141231489|OTHER|||||||0.09|||||||Students t-test|||||||0.09
70872941|NCT04216329|141231489|OTHER|||||||0.09|||||||Students t-test|||||||0.09
70872942|NCT04216329|141231489|OTHER|||||||0.09|||||||Students t-test|||||||0.09
70872943|NCT04600921|141231509|SUPERIORITY|The parameters required to calculate sample size were the expected rate of VT/VF episodes/year in the placebo group, the minimal VT/VF rate ratio to be detected in the ertugliflozin group compared with the placebo group, the average follow-up of treatment duration, the negative binomial dispersion parameter, type 1 error probability, and the desired power.|Rate Ratio|0.16|||<|0.001|TWO_SIDED|95.0|0.04|0.61||The yearly rate ratio was adjusted for baseline number of sVT/VF episodes.|Negative binomial regression model|A prespecified sensitivity analysis was done to mitigate the effect of outliers by using the robust estimation approaches for negative binomial model.|Ertugliflozin is the numerator and the placebo is the denominator.|We compared the rate of sVT/VF episodes between experimental arms after 52 weeks.The initial sample calculation was based on the mathematical formula provided by Zhu and Lakkis for comparing event rates of two negative binomial distributiuons. To detect a 30% reduction in VT/VF episode rates in the ertugliflozin group compared to placebo group, with 80% power and an alpha level of 0.05, accounting for 5% drop out in each group, a total sample size of 402 was estimated to be required.||0.61|0.04|<0.001
70872944|NCT04600921|141231510|SUPERIORITY||Rate Ratio|0.34|||||TWO_SIDED|95.0|0.12|0.97||||||The number of incident nsVT episodes were analyzed using a beta binomial model.||0.97|0.12|
70872945|NCT04600921|141231511|SUPERIORITY||Rate Ratio|0.47|||||TWO_SIDED|95.0|0.13|1.81||||||The number of appropriate ICD therapies were analyzed by using beta binomial model.||1.81|0.13|
70872946|NCT04600921|141231512|SUPERIORITY||Difference in mean change|0.17|||>|0.05|TWO_SIDED|95.0|-0.35|0.69|||Regression, Linear|||The change in NTproBNP levels was analyzed by using a multiple linear regression model.||0.69|-0.35|>0.05
70872947|NCT04600921|141231513|SUPERIORITY||Mean Difference (Final Values)|0.72|||||TWO_SIDED|95.0|-1.69|3.13||||||The change in HbA1c levels from baseline to week 52 was analyzed by multiple linear regression model.||3.13|-1.69|
70872948|NCT04600921|141231514|SUPERIORITY||Rate Ratio|0.6|||||TWO_SIDED|95.0|0.2|1.7||||||||1.7|0.2|
70872949|NCT00410046|141231521|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Admissions to hospital||||1.0
70872950|NCT00410046|141231521|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||Therapeutic warm bath sessions||||0.23
70872951|NCT00410046|141231521|SUPERIORITY_OR_OTHER|||||||0.567|||||||Fisher Exact|||Physiotherapist visits||||0.567
70872952|NCT00410046|141231521|SUPERIORITY_OR_OTHER|||||||0.475|||||||Fisher Exact|||Out-patient physician visit||||0.475
70872953|NCT00410046|141231522|SUPERIORITY_OR_OTHER|||||||0.628|||||||ANCOVA|One-way ANCOVA, baseline was a covariate.||Inpatient hospitalization days per patient||||0.628
70872954|NCT00410046|141231522|SUPERIORITY_OR_OTHER|||||||0.045|||||||ANCOVA|||Therapeutic warm bath sessions per patient||||0.045
71145878|NCT00385671|141785533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69||||0.039|TWO_SIDED|95.0|0.03|1.34||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-severity: worst pain.||1.34|0.03|0.039
71145879|NCT00385671|141785533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.244|TWO_SIDED|95.0|-0.27|1.04||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: Worst Pain.||1.04|-0.27|0.244
71145880|NCT00385671|141785534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.298|TWO_SIDED|95.0|-0.25|0.8||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: Least Pain.||0.80|-0.25|0.298
70872955|NCT00410046|141231522|SUPERIORITY_OR_OTHER|||||||0.361|||||||ANCOVA|||Physiotherapist visits per patient||||0.361
70872956|NCT00410046|141231522|SUPERIORITY_OR_OTHER|||||||0.816|||||||ANCOVA|||Out-patient physician visit per patient||||0.816
70872957|NCT00410046|141231523|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Analysis completed for patients with sick leave during the past 12 months||||1.00
70872958|NCT00410046|141231524|SUPERIORITY_OR_OTHER|||||||0.906|||||||ANCOVA|||||||0.906
70872959|NCT00410046|141231529|SUPERIORITY_OR_OTHER|||||||0.743||||||Comparison of Hospitalization 48 weeks before treatment Vs. Hospitalization during 48 treatment weeks|Fisher Exact|||||||0.743
71145881|NCT00385671|141785534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.304|TWO_SIDED|95.0|-0.25|0.81||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: Least Pain.||0.81|-0.25|0.304
71145882|NCT00385671|141785534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.989|TWO_SIDED|95.0|-0.53|0.54||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-severity: least pain.||0.54|-0.53|0.989
71145883|NCT00385671|141785535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.145|TWO_SIDED|95.0|-0.14|0.97||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-severity: pain right now.||0.97|-0.14|0.145
70872960|NCT00410046|141231529|SUPERIORITY_OR_OTHER|||||||0.362||||||Comparison of Therapeutic warm bath 48 weeks before treatment Vs. Therapeutic warm bath during 48 treatment weeks|Fisher Exact|||Comparison of percentages||||0.362
70872961|NCT00410046|141231529|SUPERIORITY_OR_OTHER|||||||0.005||||||Comparison of Visit to physiotherapist 48 weeks before treatment Vs. Visit to physiotherapist during 48 treatment weeks|Fisher Exact|||||||0.005
70872962|NCT00410046|141231529|SUPERIORITY_OR_OTHER|||||||0.091||||||Comparison of Out-patient physician 48 weeks before treatment Vs. Out-patient physician during 48 treatment weeks|Fisher Exact|||||||0.091
70872963|NCT00410046|141231530|SUPERIORITY_OR_OTHER|||||||0.576||||||Comparison of Sick leave 48 weeks before treatment Vs. Sick leave during 48 weeks of treatment|Fisher Exact|||||||0.576
70872964|NCT00482612|141231550|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Baseline TST was used as a covariate.||||||<0.0001
70872965|NCT00482612|141231550|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Baseline TST was used as a covariate.||||||<0.0001
70872966|NCT00482612|141231550|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Baseline TST was used as a covariate.||||||<0.0001
70872967|NCT00482612|141231551|SUPERIORITY_OR_OTHER|||||||0.0014|||||||ANCOVA|Baseline SL was used as a covariate.||||||0.0014
70872968|NCT00482612|141231551|SUPERIORITY_OR_OTHER|||||||0.0135|||||||ANCOVA|Baseline SL was used as a covariate.||||||0.0135
70872969|NCT00482612|141231551|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Baseline SL was used as a covariate.||||||<0.0001
70872970|NCT02033694|141231603|OTHER||Cox Proportional Hazard|1.21||||0.0004|TWO_SIDED|95.0|1.09|1.35|||Regression, Cox|||Hypothesis 1 (Vulnerable Patient Hypothesis) first fit a univariate proportional hazards regression model in which maxLCBI4mm is the only independent variable and NC-MACE during 2 years is the outcome. The null hypothesis tested by the Wald test that the regression coefficient in a proportional hazards regression model is significantly different from 0. This analysis determined whether maxLCBI4mmI is a risk factor for NC-MACE.||1.35|1.09|0.0004
71145884|NCT00385671|141785535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46||||0.112|TWO_SIDED|95.0|-0.11|1.03||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-severity: pain right now.||1.03|-0.11|0.112
71145885|NCT00385671|141785535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.865|TWO_SIDED|95.0|-0.52|0.62||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean of nighttime pain severity.||0.62|-0.52|0.865
71145886|NCT00385671|141785536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.263|TWO_SIDED|95.0|-0.26|0.95||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with general activity.||0.95|-0.26|0.263
71145887|NCT00385671|141785536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86||||0.007|TWO_SIDED|95.0|0.24|1.49||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with general activity.||1.49|0.24|0.007
71145888|NCT00385671|141785536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.102|TWO_SIDED|95.0|-0.1|1.13||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with general activity.||1.13|-0.10|0.102
71145889|NCT00385671|141785537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.922|TWO_SIDED|95.0|-0.61|0.55||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with mood.||0.55|-0.61|0.922
71145890|NCT00385671|141785537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.195|TWO_SIDED|95.0|-0.2|0.99||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with mood.||0.99|-0.20|0.195
71145891|NCT00385671|141785537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.162|TWO_SIDED|95.0|-0.17|1.02||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with mood.||1.02|-0.17|0.162
71145892|NCT00385671|141785538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.541|TWO_SIDED|95.0|-0.46|0.87||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with walking ability.||0.87|-0.46|0.541
71145893|NCT00385671|141785538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68||||0.051|TWO_SIDED|95.0|0.0|1.36||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with walking ability.||1.36|-0.00|0.051
70872971|NCT02033694|141231603|OTHER||Cox Proportional Hazard|1.45|||<|0.0001|TWO_SIDED|95.0|1.3|1.6|||Regression, Cox|||Hypothesis 2 (Vulnerable Plaque Hypothesis) first fit a univariate proportional hazards regression model in which maxLCBI4mm in the coronary artery segment is the measure of exposure and NC-MACE during 2 years caused by a new culprit lesion in that segment is the outcome. This analysis was performed with adjustment for the potential clustering effect within patient utilizing the Wei, Lin and Weissfeld (WLW) methodology. This analysis determined whether maxLCBI4mm is a risk factor NC-MACE.||1.60|1.30|<0.0001
70872972|NCT02033694|141231604|OTHER||Cox Proportional Hazard|2.18|||<|0.0001|TWO_SIDED|95.0|1.48|3.22|||Regression, Cox|||Secondary Hypothesis 1 (Vulnerable Patient)- Cox proportional hazards regression model to assess a threshold of maxLCBI4mm \> 400 as the independent variable and NC-MACE during 2 years as the outcome.||3.22|1.48|<0.0001
70872973|NCT02033694|141231604|OTHER||Cox Proportional Hazard|4.22|||<|0.0001|TWO_SIDED|95.0|2.39|7.45|||Regression, Cox|||Secondary Hypothesis 2 (Vulnerable Plaque)- Cox proportional hazards regression model to assess a threshold of maxLCBI4mm \> 400 in the coronary artery segment as the independent variable and NC-MACE during 2 years caused by a new culprit lesion in that segment is the outcome.||7.45|2.39|<0.0001
70872974|NCT02899988|141231605|SUPERIORITY||Risk Difference (RD)|29.4||||0.009|TWO_SIDED|95.0|16.9|41.9|||Regression, Logistic|||||41.9|16.9|0.009
70872975|NCT02899988|141231605|SUPERIORITY||Risk Difference (RD)|58.8|||<|0.001|TWO_SIDED|95.0|45.3|72.3|||Regression, Logistic|||||72.3|45.3|<0.001
70872976|NCT02899988|141231605|SUPERIORITY||Risk Difference (RD)|66.7|||<|0.001|TWO_SIDED|95.0|53.7|79.6|||Regression, Logistic|||||79.6|53.7|<0.001
70872977|NCT02899988|141231606|SUPERIORITY||Risk Difference (RD)|15.7||||0.039|TWO_SIDED|95.0|5.7|25.7|||Regression, Logistic|||||25.7|5.7|0.039
70872978|NCT02899988|141231606|SUPERIORITY||Risk Difference (RD)|31.4||||0.007|TWO_SIDED|95.0|18.6|44.1|||Regression, Logistic|||||44.1|18.6|0.007
70872979|NCT02899988|141231606|SUPERIORITY||Risk Difference (RD)|31.4||||0.007|TWO_SIDED|95.0|18.6|44.1|||Regression, Logistic|||||44.1|18.6|0.007
70872980|NCT02899988|141231607|SUPERIORITY||Risk Difference (RD)|22.49|||<|0.001|TWO_SIDED|95.0|5.62|89.97|||Regression, Logistic|||||89.97|5.62|<0.001
70872981|NCT02899988|141231607|SUPERIORITY||Risk Difference (RD)|74.6|||<|0.001|TWO_SIDED|95.0|62.1|87.0|||Regression, Logistic|||||87.0|62.1|<0.001
70872982|NCT02899988|141231607|SUPERIORITY||Risk Difference (RD)|70.7|||<|0.001|TWO_SIDED|95.0|57.6|83.7|||Regression, Logistic|||||83.7|57.6|<0.001
70872983|NCT02899988|141231608|SUPERIORITY||Risk Difference (RD)|15.7||||0.041|TWO_SIDED|95.0|5.7|25.7|||Regression, Logistic|||sPGA (0)||25.7|5.7|0.041
70872984|NCT02899988|141231608|SUPERIORITY||Risk Difference (RD)|31.4||||0.007|TWO_SIDED|95.0|18.6|44.1|||Regression, Logistic|||sPGA (0)||44.1|18.6|0.007
70872985|NCT02899988|141231608|SUPERIORITY||Risk Difference (RD)|31.4||||0.008|TWO_SIDED|95.0|18.6|44.1|||Regression, Logistic|||sPGA (0)||44.1|18.6|0.008
70872986|NCT02899988|141231608|SUPERIORITY||Risk Difference (RD)|35.3|||<|0.001|TWO_SIDED|95.0|21.5|49.1|||Regression, Logistic|||sPGA (0/1)||49.1|21.5|<0.001
70872987|NCT02899988|141231608|SUPERIORITY||Risk Difference (RD)|68.7|||<|0.001|TWO_SIDED|95.0|55.6|81.7|||Regression, Logistic|||sPGA (0/1)||81.7|55.6|<0.001
70872988|NCT02899988|141231608|SUPERIORITY||Risk Difference (RD)|66.7|||<|0.001|TWO_SIDED|95.0|53.4|80.0|||Regression, Logistic|||sPGA (0/1)||80.0|53.4|<0.001
70872989|NCT02899988|141231609|SUPERIORITY||Mean Difference (Net)|-26.84|STANDARD_ERROR_OF_MEAN|3.26|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
70872990|NCT02899988|141231609|SUPERIORITY||Mean Difference (Net)|-37.99|STANDARD_ERROR_OF_MEAN|3.29|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
70872991|NCT02899988|141231609|SUPERIORITY||Mean Difference (Net)|-29.32|STANDARD_ERROR_OF_MEAN|3.22|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
70872992|NCT02899988|141231610|SUPERIORITY||Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
70872993|NCT02899988|141231610|SUPERIORITY||Mean Difference (Net)|2.56|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
70872994|NCT02899988|141231610|SUPERIORITY||Mean Difference (Net)|2.47|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
70872995|NCT02899988|141231611|SUPERIORITY||Mean Difference (Net)|-8.12|STANDARD_ERROR_OF_MEAN|0.98|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
70872996|NCT02899988|141231611|SUPERIORITY||Mean Difference (Net)|-9.11|STANDARD_ERROR_OF_MEAN|0.97|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
70872997|NCT02899988|141231611|SUPERIORITY||Mean Difference (Net)|-8.57|STANDARD_ERROR_OF_MEAN|0.98|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
70872998|NCT02899988|141231612|SUPERIORITY||Mean Difference (Net)|2.11|STANDARD_ERROR_OF_MEAN|1.24||0.009|TWO_SIDED||||||ANCOVA|||Mental Component Summary (MCS)||||0.009
70872999|NCT02899988|141231612|SUPERIORITY||Mean Difference (Net)|2.74|STANDARD_ERROR_OF_MEAN|1.22||0.002|TWO_SIDED||||||ANCOVA|||Mental Component Summary (MCS)||||0.002
70873000|NCT02899988|141231612|SUPERIORITY||Mean Difference (Net)|1.52|STANDARD_ERROR_OF_MEAN|1.24||0.087|TWO_SIDED||||||ANCOVA|||Mental Component Summary (MCS)||||0.087
70873001|NCT02899988|141231612|SUPERIORITY||Mean Difference (Net)|3.35|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED||||||ANCOVA|||Physical Component Summary||||<0.001
70873002|NCT02899988|141231612|SUPERIORITY||Mean Difference (Net)|3.16|STANDARD_ERROR_OF_MEAN|1.18|<|0.001|TWO_SIDED||||||ANCOVA|||Physical Component Summary||||<0.001
71145894|NCT00385671|141785538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.173|TWO_SIDED|95.0|-0.21|1.15||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with walking ability.||1.15|-0.21|0.173
70873003|NCT02899988|141231612|SUPERIORITY||Mean Difference (Net)|3.86|STANDARD_ERROR_OF_MEAN|1.19|<|0.001|TWO_SIDED||||||ANCOVA|||Physical Component Summary||||<0.001
70873004|NCT01059825|141231617|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.45||||0.002|TWO_SIDED|80.0|-0.65|-0.25||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||The null hypothesis is that there is no difference between ertugliflozin and placebo on the primary endpoint.||-0.25|-0.65|0.002
70873005|NCT01059825|141231617|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.69||||0|TWO_SIDED|80.0|-0.89|-0.49||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||The null hypothesis is that there is no difference between ertugliflozin and placebo on the primary endpoint.||-0.49|-0.89|0.000
71145895|NCT00385671|141785539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.451|TWO_SIDED|95.0|-0.4|0.9||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly BPI-interference with normal work.||0.90|-0.40|0.451
71145896|NCT00385671|141785539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.485|TWO_SIDED|95.0|-0.43|0.9||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with normal work.||0.90|-0.43|0.485
71145897|NCT00385671|141785539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.969|TWO_SIDED|95.0|-0.68|0.65||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with normal work.||0.65|-0.68|0.969
71145898|NCT00385671|141785540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.479|TWO_SIDED|95.0|-0.36|0.76||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly BPI-interference with relations with other people.||0.76|-0.36|0.479
71145899|NCT00385671|141785540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.301|TWO_SIDED|95.0|-0.27|0.87||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with relations with other people.||0.87|-0.27|0.301
71145900|NCT00385671|141785540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.731|TWO_SIDED|95.0|-0.47|0.67||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with relations with other people.||0.67|-0.47|0.731
71145901|NCT00385671|141785541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.528|TWO_SIDED|95.0|-0.45|0.87||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with sleep.||0.87|-0.45|0.528
71145902|NCT00385671|141785541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.626|TWO_SIDED|95.0|-0.84|0.51||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with sleep.||0.51|-0.84|0.626
71145903|NCT00385671|141785541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.27|TWO_SIDED|95.0|-1.06|0.3||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with sleep.||0.30|-1.06|0.270
70873006|NCT01059825|141231617|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.62||||0|TWO_SIDED|80.0|-0.82|-0.42||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||The null hypothesis is that there is no difference between ertugliflozin and placebo on the primary endpoint.||-0.42|-0.82|0.000
70873007|NCT01059825|141231617|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.72||||0|TWO_SIDED|80.0|-0.93|-0.52||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||The null hypothesis is that there is no difference between ertugliflozin and placebo on the primary endpoint.||-0.52|-0.93|0.000
71145904|NCT00385671|141785542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.098|TWO_SIDED|95.0|-0.1|1.13||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with enjoyment of life.||1.13|-0.10|0.098
71145905|NCT00385671|141785542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.383|TWO_SIDED|95.0|-0.35|0.9||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with enjoyment of life.||0.90|-0.35|0.383
71145906|NCT00385671|141785542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.452|TWO_SIDED|95.0|-0.86|0.39||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with enjoyment of life.||0.39|-0.86|0.452
71145907|NCT00385671|141785543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.309|TWO_SIDED|95.0|-0.26|0.82||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI mean interference score.||0.82|-0.26|0.309
71145908|NCT00385671|141785543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38||||0.174|TWO_SIDED|95.0|-0.17|0.93||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI mean interference score.||0.93|-0.17|0.174
70873008|NCT01059825|141231617|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.76||||0|TWO_SIDED|80.0|-0.97|-0.56||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.56|-0.97|0.000
71145909|NCT00385671|141785543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.717|TWO_SIDED|95.0|-0.45|0.65||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI mean interference score.||0.65|-0.45|0.717
71145910|NCT00385671|141785544|SUPERIORITY_OR_OTHER|||||||0.975||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with ≥ 30% reduction in the weekly mean 24 hour average pain score at 12 weeks.||||0.975
71145911|NCT00385671|141785544|SUPERIORITY_OR_OTHER|||||||0.448||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with ≥ 30% reduction in the weekly mean 24 hour average pain score at 12 weeks.||||0.448
71145912|NCT00385671|141785544|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with ≥ 30% reduction in the weekly mean 24 hour average pain score at 12 weeks.||||0.280
71145913|NCT00385671|141785545|SUPERIORITY_OR_OTHER|||||||0.548||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of patients with a reduction of ≥ 50% in Weekly mean of 24 hour average pain score.||||0.548
71145914|NCT00385671|141785545|SUPERIORITY_OR_OTHER|||||||0.599||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of patients with a reduction of ≥ 50% in Weekly mean of 24 hour average pain score.||||0.599
71145915|NCT00385671|141785545|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference in the number of patients with a reduction of ≥ 50% in Weekly mean of 24 hour average pain score.||||1.00
71145916|NCT00385671|141785546|SUPERIORITY_OR_OTHER|||||||0.905||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of Participants with a ≥ 2-points reduction on the weekly average of the daily 24-hour average pain scale at 12 Weeks.||||0.905
71145917|NCT00385671|141785546|SUPERIORITY_OR_OTHER|||||||0.368||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of Participants with a ≥ 2-points reduction on the weekly average of the daily 24-hour average pain scale at 12 Weeks.||||0.368
70873009|NCT01059825|141231618|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.13||||0.049|TWO_SIDED|80.0|-0.24|-0.03||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.03|-0.24|0.049
71145918|NCT00385671|141785546|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of Participants with a ≥ 2-points reduction on the weekly average of the daily 24-hour average pain scale at 12 Weeks.||||0.200
71145919|NCT00385671|141785547|SUPERIORITY_OR_OTHER|||||||0.572||95.0||||P-value is for GTS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ GTS scores.||||0.572
71145920|NCT00385671|141785547|SUPERIORITY_OR_OTHER|||||||0.345||95.0||||P-value is for GTS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 weeks in LSEQ GTS scores.||||0.345
71145921|NCT00385671|141785547|SUPERIORITY_OR_OTHER|||||||0.699||95.0||||P-value is for GTS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ GTS scores.||||0.699
70873010|NCT01059825|141231618|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.29||||0|TWO_SIDED|80.0|-0.39|-0.18||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.18|-0.39|0.000
70873011|NCT01059825|141231618|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.22||||0.004|TWO_SIDED|80.0|-0.32|-0.11||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.11|-0.32|0.004
71145922|NCT00385671|141785547|SUPERIORITY_OR_OTHER|||||||0.954||95.0||||P-value is for QOS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ QOS scores.||||0.954
71145923|NCT00385671|141785547|SUPERIORITY_OR_OTHER|||||||0.734||95.0||||P-value is for QOS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in LSEQ QOS scores.||||0.734
70873012|NCT01059825|141231618|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.17||||0.02|TWO_SIDED|80.0|-0.27|-0.06||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.06|-0.27|0.020
70873013|NCT01059825|141231618|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.25||||0.001|TWO_SIDED|80.0|-0.36|-0.15||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.15|-0.36|0.001
70873014|NCT01059825|141231619|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.37||||0|TWO_SIDED|80.0|-0.5|-0.23||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.23|-0.50|0.000
70873015|NCT01059825|141231619|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.45||||0|TWO_SIDED|80.0|-0.59|-0.32||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.32|-0.59|0.000
71145924|NCT00385671|141785547|SUPERIORITY_OR_OTHER|||||||0.693||95.0||||P-value is for QOS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ QOS.||||0.693
71145925|NCT00385671|141785547|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||P-value is for AFS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ AFS scores.||||0.720
71145926|NCT00385671|141785547|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||P-value is for AFS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in LSEQ AFS scores.||||0.722
71145927|NCT00385671|141785547|SUPERIORITY_OR_OTHER|||||||0.48||95.0||||P-value is for AFS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ AFS scores.||||0.480
71145928|NCT00385671|141785547|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||P-value is for BFW. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ BFW scores.||||0.498
71145929|NCT00385671|141785547|SUPERIORITY_OR_OTHER|||||||0.865||95.0||||P-value is for BFW. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in LSEQ BFW scores.||||0.865
71145930|NCT00385671|141785547|SUPERIORITY_OR_OTHER|||||||0.408||95.0||||P-value is for BFW. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ BFW scores.||||0.408
71145931|NCT00385671|141785548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.635|TWO_SIDED|95.0|-2.18|1.33||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS total score.||1.33|-2.18|0.635
71145932|NCT00385671|141785548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.092|TWO_SIDED|95.0|-3.24|0.24||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS total score.||0.24|-3.24|0.092
70873016|NCT01059825|141231619|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.44||||0|TWO_SIDED|80.0|-0.57|-0.3||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.30|-0.57|0.000
70873017|NCT01059825|141231619|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.36||||0|TWO_SIDED|80.0|-0.49|-0.22||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.22|-0.49|0.000
71145933|NCT00385671|141785548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07||||0.221|TWO_SIDED|95.0|-2.8|0.65||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS total score.||0.65|-2.80|0.221
71145934|NCT00385671|141785548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.974|TWO_SIDED|95.0|-0.88|0.85||P-value is for item 1. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS Item 1 score.||0.85|-0.88|0.974
70873018|NCT01059825|141231619|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.44||||0|TWO_SIDED|80.0|-0.57|-0.3||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.30|-0.57|0.000
71145935|NCT00385671|141785548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75||||0.093|TWO_SIDED|95.0|-1.63|0.13||P-value is for Item 1. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS Item 1 score.||0.13|-1.63|0.093
70873019|NCT01059825|141231620|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.47||||0|TWO_SIDED|80.0|-0.64|-0.3||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.30|-0.64|0.000
70873020|NCT01059825|141231620|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.66||||0|TWO_SIDED|80.0|-0.83|-0.49||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.49|-0.83|0.000
70873021|NCT01059825|141231620|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.63||||0|TWO_SIDED|80.0|-0.8|-0.45||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.45|-0.80|0.000
70873022|NCT01059825|141231620|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.65||||0|TWO_SIDED|80.0|-0.82|-0.47||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.47|-0.82|0.000
70873023|NCT01059825|141231620|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.67||||0|TWO_SIDED|80.0|-0.84|-0.5||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.50|-0.84|0.000
70873024|NCT01059825|141231622|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.15||||0.007|TWO_SIDED|80.0|-1.75|-0.55||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.55|-1.75|0.007
70873025|NCT01059825|141231622|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.75||||0|TWO_SIDED|80.0|-2.35|-1.14||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.14|-2.35|0.000
70873026|NCT01059825|141231622|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.15||||0|TWO_SIDED|80.0|-2.76|-1.54||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.54|-2.76|0.000
70873027|NCT01059825|141231622|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.91||||0|TWO_SIDED|80.0|-2.52|-1.3||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.30|-2.52|0.000
70873028|NCT01059825|141231622|SUPERIORITY_OR_OTHER||Difference in least squares means|0.45||||0.833|TWO_SIDED|80.0|-0.15|1.06||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.06|-0.15|0.833
70873029|NCT01059825|141231623|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.42||||0.043|TWO_SIDED|80.0|-0.73|-0.11||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.11|-0.73|0.043
70873030|NCT01059825|141231623|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.13||||0|TWO_SIDED|80.0|-1.44|-0.81||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.81|-1.44|0.000
70873031|NCT01059825|141231623|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.9||||0|TWO_SIDED|80.0|-1.22|-0.59||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.59|-1.22|0.000
70873032|NCT01059825|141231623|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.87||||0|TWO_SIDED|80.0|-1.18|-0.55||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.55|-1.18|0.000
70873033|NCT01059825|141231623|SUPERIORITY_OR_OTHER||Difference in least squares means|0.45||||0.967|TWO_SIDED|80.0|0.14|0.76||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.76|0.14|0.967
70873034|NCT01059825|141231624|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.76||||0.008|TWO_SIDED|80.0|-1.17|-0.36||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.36|-1.17|0.008
70873035|NCT01059825|141231624|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.32||||0|TWO_SIDED|80.0|-1.73|-0.91||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.91|-1.73|0.000
70873036|NCT01059825|141231624|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.24||||0|TWO_SIDED|80.0|-1.65|-0.83||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.83|-1.65|0.000
70873037|NCT01059825|141231624|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|-1.08||||0|TWO_SIDED|80.0|-1.49|-0.67||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward..||||-0.67|-1.49|0.000
70873038|NCT01059825|141231624|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.45||||0.922|TWO_SIDED|80.0|0.04|0.86||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.86|0.04|0.922
70873039|NCT01059825|141231625|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.03||||0.003|TWO_SIDED|80.0|-1.51|-0.56||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.56|-1.51|0.003
70873040|NCT01059825|141231625|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.57||||0|TWO_SIDED|80.0|-2.04|-1.09||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.09|-2.04|0.000
70873041|NCT01059825|141231625|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.68||||0|TWO_SIDED|80.0|-2.16|-1.21||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.21|-2.16|0.000
70873042|NCT01059825|141231625|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.78||||0|TWO_SIDED|80.0|-2.26|-1.3||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.30|-2.26|0.000
70873043|NCT01059825|141231625|SUPERIORITY_OR_OTHER||Difference in least squares means|0.24||||0.741|TWO_SIDED|80.0|-0.24|0.71||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.71|-0.24|0.741
70873044|NCT01059825|141231627|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.13||||0.163|TWO_SIDED|80.0|-4.92|0.65||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.65|-4.92|0.163
70873045|NCT01059825|141231627|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.48||||0.056|TWO_SIDED|80.0|-6.28|-0.68||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.68|-6.28|0.056
70873046|NCT01059825|141231627|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.88||||0.096|TWO_SIDED|80.0|-5.7|-0.05||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.05|-5.70|0.096
70873047|NCT01059825|141231627|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.37||||0.064|TWO_SIDED|80.0|-6.21|-0.53||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.53|-6.21|0.064
70873048|NCT01059825|141231627|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.54||||0.403|TWO_SIDED|80.0|-3.33|2.26||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||2.26|-3.33|0.403
70873049|NCT01059825|141231628|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.37||||0.425|TWO_SIDED|80.0|-2.91|2.17||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||2.17|-2.91|0.425
70873050|NCT01059825|141231628|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.81||||0.082|TWO_SIDED|80.0|-5.38|-0.23||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.23|-5.38|0.082
70873051|NCT01059825|141231628|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.35||||0.43|TWO_SIDED|80.0|-2.92|2.21||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||2.21|-2.92|0.430
70873052|NCT01059825|141231628|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.47||||0.043|TWO_SIDED|80.0|-6.05|-0.89||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.89|-6.05|0.043
70873053|NCT01059825|141231628|SUPERIORITY_OR_OTHER||Difference in least squares means|1.01||||0.694|TWO_SIDED|80.0|-1.55|3.58||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||3.58|-1.55|0.694
70873054|NCT01059825|141231629|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.38||||0.234|TWO_SIDED|80.0|-3.81|1.05||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.05|-3.81|0.234
70873055|NCT01059825|141231629|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.59||||0.087|TWO_SIDED|80.0|-5.03|-0.14||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.14|-5.03|0.087
70873056|NCT01059825|141231629|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.86||||0.068|TWO_SIDED|80.0|-5.33|-0.4||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.40|-5.33|0.068
70873057|NCT01059825|141231629|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.77||||0.346|TWO_SIDED|80.0|-3.25|1.71||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.71|-3.25|0.346
70873058|NCT01059825|141231629|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.76||||0.346|TWO_SIDED|80.0|-3.21|1.7||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.70|-3.21|0.346
70873059|NCT01059825|141231630|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.1||||0.306|TWO_SIDED|80.0|-3.87|1.67||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.67|-3.87|0.306
70873060|NCT01059825|141231630|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.41||||0.133|TWO_SIDED|80.0|-5.19|0.37||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.37|-5.19|0.133
70873061|NCT01059825|141231630|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.61||||0.117|TWO_SIDED|80.0|-5.42|0.2||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.20|-5.42|0.117
70873062|NCT01059825|141231630|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.87||||0.097|TWO_SIDED|80.0|-5.69|-0.04||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.04|-5.69|0.097
70873063|NCT01059825|141231630|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.0||||0.179|TWO_SIDED|80.0|-4.78|0.79||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.79|-4.78|0.179
70873064|NCT01059825|141231632|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.93||||0.072|TWO_SIDED|80.0|-3.62|-0.24||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.24|-3.62|0.072
70873065|NCT01059825|141231632|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.81||||0.086|TWO_SIDED|80.0|-3.51|-0.11||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.11|-3.51|0.086
70873066|NCT01059825|141231632|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.99||||0.002|TWO_SIDED|80.0|-5.71|-2.27||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-2.27|-5.71|0.002
70873067|NCT01059825|141231632|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.64||||0.025|TWO_SIDED|80.0|-4.37|-0.92||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.92|-4.37|0.025
70873068|NCT01059825|141231632|SUPERIORITY_OR_OTHER||Difference in least squares means|0.88||||0.746|TWO_SIDED|80.0|-0.82|2.58||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||2.58|-0.82|0.746
70873069|NCT01059825|141231633|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.69||||0.289|TWO_SIDED|80.0|-2.27|0.9||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.90|-2.27|0.289
70873070|NCT01059825|141231633|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.7||||0.288|TWO_SIDED|80.0|-2.31|0.91||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.91|-2.31|0.288
70873071|NCT01059825|141231633|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.41||||0.13|TWO_SIDED|80.0|-3.01|0.19||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.19|-3.01|0.130
70873072|NCT01059825|141231633|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.44||||0.026|TWO_SIDED|80.0|-4.05|-0.84||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.84|-4.05|0.026
70873073|NCT01059825|141231633|SUPERIORITY_OR_OTHER||Difference in least squares means|1.49||||0.883|TWO_SIDED|80.0|-0.11|3.08||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||3.08|-0.11|0.883
70873074|NCT01059825|141231634|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.67||||0.063|TWO_SIDED|80.0|-3.07|-0.27||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.27|-3.07|0.063
70873075|NCT01059825|141231634|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.29||||0.019|TWO_SIDED|80.0|-3.69|-0.88||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.88|-3.69|0.019
70873076|NCT01059825|141231634|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.01||||0.035|TWO_SIDED|80.0|-3.43|-0.59||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.59|-3.43|0.035
70873077|NCT01059825|141231634|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.3||||0.121|TWO_SIDED|80.0|-2.73|0.12||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.12|-2.73|0.121
70873078|NCT01059825|141231634|SUPERIORITY_OR_OTHER||Difference in least squares means|0.29||||0.602|TWO_SIDED|80.0|-1.13|1.7||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.70|-1.13|0.602
70873079|NCT01059825|141231635|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.2||||0.045|TWO_SIDED|80.0|-3.86|-0.54||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.54|-3.86|0.045
70873080|NCT01059825|141231635|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.49||||0.126|TWO_SIDED|80.0|-3.16|0.18||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.18|-3.16|0.126
70873081|NCT01059825|141231635|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.03||||0.011|TWO_SIDED|80.0|-4.72|-1.34||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.34|-4.72|0.011
70873082|NCT01059825|141231635|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.99||||0.066|TWO_SIDED|80.0|-3.69|-0.3||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.30|-3.69|0.066
70873083|NCT01059825|141231635|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.48||||0.357|TWO_SIDED|80.0|-2.15|1.19||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.19|-2.15|0.357
70873084|NCT01059825|141231637|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.99||||0|TWO_SIDED|80.0|-28.29|-13.69||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-13.69|-28.29|0.000
70873085|NCT01059825|141231637|SUPERIORITY_OR_OTHER||Difference in least squares means|-25.82||||0|TWO_SIDED|80.0|-33.17|-18.47||P-value is one-sided.P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-18.47|-33.17|0.000
70873086|NCT01059825|141231637|SUPERIORITY_OR_OTHER||Difference in least squares means|-34.23||||0|TWO_SIDED|80.0|-41.64|-26.83||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-26.83|-41.64|0.000
70873087|NCT01059825|141231637|SUPERIORITY_OR_OTHER||Difference in least squares means|-32.02||||0|TWO_SIDED|80.0|-39.49|-24.56||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-24.56|-39.49|0.000
70873088|NCT01059825|141231637|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.05||||0|TWO_SIDED|80.0|-27.39|-12.72||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-12.72|-27.39|0.000
70873089|NCT01059825|141231638|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.96||||0|TWO_SIDED|80.0|-28.58|-13.34||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-13.34|-28.58|0.000
70873090|NCT01059825|141231638|SUPERIORITY_OR_OTHER||Difference in least squares means|-21.57||||0|TWO_SIDED|80.0|-29.27|-13.86||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-13.86|-29.27|0.000
70873091|NCT01059825|141231638|SUPERIORITY_OR_OTHER||Difference in least squares means|-32.54||||0|TWO_SIDED|80.0|-40.2|-24.88||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-24.88|-40.20|0.000
70873092|NCT01059825|141231638|SUPERIORITY_OR_OTHER||Difference in least squares means|-22.33||||0|TWO_SIDED|80.0|-30.05|-14.61||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-14.61|-30.05|0.000
70873093|NCT01059825|141231638|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.57||||0|TWO_SIDED|80.0|-28.19|-12.96||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-12.96|-28.19|0.000
70873094|NCT01059825|141231639|SUPERIORITY_OR_OTHER||Difference in least squares means|-22.09||||0|TWO_SIDED|80.0|-29.16|-15.01||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-15.01|-29.16|0.000
70873095|NCT01059825|141231639|SUPERIORITY_OR_OTHER||Difference in least squares means|-27.94||||0|TWO_SIDED|80.0|-35.06|-20.83||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-20.83|-35.06|0.000
70873096|NCT01059825|141231639|SUPERIORITY_OR_OTHER||Difference in least squares means|-33.12||||0|TWO_SIDED|80.0|-40.29|-25.95||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-25.95|-40.29|0.000
70873097|NCT01059825|141231639|SUPERIORITY_OR_OTHER||Difference in least squares means|-31.79||||0|TWO_SIDED|80.0|-39.02|-24.56||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-24.56|-39.02|0.000
70873098|NCT01059825|141231639|SUPERIORITY_OR_OTHER||Difference in least squares means|-23.17||||0|TWO_SIDED|80.0|-30.28|-16.07||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-16.07|-30.28|0.000
70873099|NCT01059825|141231640|SUPERIORITY_OR_OTHER||Difference in least squares means|-22.07||||0|TWO_SIDED|80.0|-28.87|-15.27||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-15.27|-28.87|0.000
70873100|NCT01059825|141231640|SUPERIORITY_OR_OTHER||Difference in least squares means|-28.51||||0|TWO_SIDED|80.0|-35.35|-21.67||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-21.67|-35.35|0.000
70873101|NCT01059825|141231640|SUPERIORITY_OR_OTHER||Difference in least squares means|-35.4||||0|TWO_SIDED|80.0|-42.3|-28.51||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-28.51|-42.30|0.000
70873102|NCT01059825|141231640|SUPERIORITY_OR_OTHER||Difference in least squares means|-34.81||||0|TWO_SIDED|80.0|-41.76|-27.86||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-27.86|-41.76|0.000
70873103|NCT01059825|141231640|SUPERIORITY_OR_OTHER||Difference in least squares means|-22.75||||0|TWO_SIDED|80.0|-29.58|-15.92||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-15.92|-29.58|0.000
70873104|NCT05620563|141231662|SUPERIORITY||Posterior Mean Difference|0.3|||||TWO_SIDED|95.0|-0.28|0.87|||||Posterior mean difference with 95% credible interval is reported.|||0.87|-0.28|
70873105|NCT05620563|141231663|SUPERIORITY||Posterior Mean Difference|-0.15|||||TWO_SIDED|95.0|-1.13|0.82|||||Posterior mean difference with 95% credible interval is reported.|||0.82|-1.13|
70873106|NCT05620563|141231664|SUPERIORITY||Posterior Mean Difference|-0.47|||||TWO_SIDED|95.0|-0.99|0.05|||||Posterior mean difference with 95% credible interval is reported.|||0.05|-0.99|
70873107|NCT05620563|141231665|SUPERIORITY||Posterior Mean Difference|-0.55|||||TWO_SIDED|95.0|-3.82|2.69|||||Posterior mean difference with 95% credible interval is reported.|||2.69|-3.82|
70873108|NCT05620563|141231666|SUPERIORITY||Posterior Mean Difference|0.09|||||TWO_SIDED|95.0|-0.33|0.51|||||Posterior mean difference with 95% credible interval is reported.|||0.51|-0.33|
70873109|NCT05620563|141231667|SUPERIORITY||Posterior Mean Difference|0.3|||||TWO_SIDED|95.0|-0.35|0.95|||||Posterior mean difference with 95% credible interval is reported.|||0.95|-0.35|
70873110|NCT05620563|141231668|SUPERIORITY||Posterior Mean Difference|2.2|||||TWO_SIDED|95.0|-5.7|9.99|||||Posterior mean difference with 95% credible interval is reported.|||9.99|-5.70|
70873111|NCT05620563|141231669|SUPERIORITY||Posterior Mean Difference|-0.07|||||TWO_SIDED|95.0|-0.39|0.24|||||Posterior mean difference with 95% credible interval is reported.|||0.24|-0.39|
70873112|NCT05620563|141231670|SUPERIORITY||Posterior Mean Difference|24.16|||||TWO_SIDED|95.0|-115.48|166.06|||||Posterior mean difference with 95% credible interval is reported.|||166.06|-115.48|
70873113|NCT05620563|141231671|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.09|0.08|||||Posterior mean difference with 95% credible interval is reported.|||0.08|-0.09|
71145936|NCT00385671|141785548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74||||0.091|TWO_SIDED|95.0|-1.59|0.12||P-value is for item 1. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS Item 1 score.||0.12|-1.59|0.091
71145937|NCT00385671|141785548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.733|TWO_SIDED|95.0|-0.75|0.52||P-value is for item 2. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS Item 2 score.||0.52|-0.75|0.733
71145938|NCT00385671|141785548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.102|TWO_SIDED|95.0|-1.15|0.11||P-value is for item 2. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS item 2 score.||0.11|-1.15|0.102
71145939|NCT00385671|141785548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.193|TWO_SIDED|95.0|-1.04|0.21||P-value is for item 2. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS item 2 score.||0.21|-1.04|0.193
71145940|NCT00385671|141785548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.584|TWO_SIDED|95.0|-0.76|0.43||P-value is for item 3. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS item 3 score.||0.43|-0.76|0.584
71145941|NCT00385671|141785548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.077|TWO_SIDED|95.0|-1.12|0.06||P-value is for item 3. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS item 3 score.||0.06|-1.12|0.077
70873114|NCT00869206|141231672|NON_INFERIORITY_OR_EQUIVALENCE|Based on the published data on the effect of a standard of dosing schedule of \> zoledronic acid compared to placebo, we choose ∆= 7%, πT= 42%, and πS= 35%. With a total of 1230 eligible patients (615 per arm), the probability of rejecting the null hypothesis using a one-sided test is at most 0.05 (Type I error α) when θ≥ 7% and the probability of rejecting the null hypothesis (the power) is at least 82% when θ≤0|||||<=|0.05|||||||Cochran-Mantel-Haenszel|||||||<=.05
70873115|NCT00869206|141231673|SUPERIORITY_OR_OTHER||Slope|-0.00394|STANDARD_ERROR_OF_MEAN|0.00962||0.68|TWO_SIDED||||||Mixed Models Analysis|Model is adjusted for tumor type, baseline creatinine, prior SREs, prior bisphosphonates, age, gender, race, BSA, and baseline performance status||||||0.68
70873116|NCT00869206|141231674|SUPERIORITY_OR_OTHER||Slope|0.0016|STANDARD_ERROR_OF_MEAN|0.0034||0.64|TWO_SIDED||||||Mixed Models Analysis|Adjusted for tumor type, baseline creatinine, prior SRE, prior bisphosphonates, age, gender, BSA, race, and baseline performance status||||||0.64
71145942|NCT00385671|141785548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.221|TWO_SIDED|95.0|-0.95|0.22||P-value is for item 3. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS item 3 score.||0.22|-0.95|0.221
71145943|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.82||||0.096|TWO_SIDED|95.0|-3.96|0.32||P-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.||0.32|-3.96|0.096
70873117|NCT00869206|141231676|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.1|TWO_SIDED|95.0|-0.3|1.7|||Cochran-Mantel-Haenszel|||||1.7|-0.3|0.10
71145944|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.353|TWO_SIDED|95.0|-3.16|1.13||P-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.||1.13|-3.16|0.353
70954590|NCT04679935|141412130|OTHER|Analysis was purely descriptive.|Difference|-3.74|STANDARD_ERROR_OF_MEAN|1.84|||TWO_SIDED|95.0|-7.47|-0.01|||MMRM model|||Week 40||-0.01|-7.47|
71145945|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81||||0.444|TWO_SIDED|95.0|-1.27|2.88||P-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.||2.88|-1.27|0.444
70873118|NCT00411645|141231684|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.902||||0.789|TWO_SIDED|95.0|0.424|1.92||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|||1.920|0.424|0.789
70954591|NCT04679935|141412130|OTHER|Analysis was purely descriptive.|Difference|-4.15|STANDARD_ERROR_OF_MEAN|2.3|||TWO_SIDED|95.0|-8.78|-0.48|||MMRM model|||Week 44||-0.48|-8.78|
71145946|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.682|TWO_SIDED|95.0|-2.29|3.48||P-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.||3.48|-2.29|0.682
70873119|NCT00411645|141231685|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.721||||0.056|TWO_SIDED|95.0|0.515|1.008||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of pp65 antigenemia assay||1.008|0.515|0.056
70954592|NCT04679935|141412130|OTHER|Analysis was purely descriptive.|Difference|-5.35|STANDARD_ERROR_OF_MEAN|2.38|||TWO_SIDED|95.0|-10.13|-0.58|||MMRM model|||Week 48||-0.58|-10.13|
71145947|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13||||0.45|TWO_SIDED|95.0|-4.08|1.82||P-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.||1.82|-4.08|0.450
70954593|NCT04679935|141412130|OTHER|Analysis was purely descriptive.|Difference|-4.19|STANDARD_ERROR_OF_MEAN|2.28|||TWO_SIDED|95.0|-8.77|0.39|||MMRM model|||Week 52||0.39|-8.77|
71145948|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.73||||0.218|TWO_SIDED|95.0|-4.49|1.04||P-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.||1.04|-4.49|0.218
71145949|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.747|TWO_SIDED|95.0|-0.36|0.26||P-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.||0.26|-0.36|0.747
71145950|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.39|TWO_SIDED|95.0|-0.18|0.45||P-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.||0.45|-0.18|0.390
71145951|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.228|TWO_SIDED|95.0|-0.12|0.49||P-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.||0.49|-0.12|0.228
70954594|NCT04679935|141412130|OTHER|Analysis was purely descriptive.|Difference|-4.36|STANDARD_ERROR_OF_MEAN|2.09|||TWO_SIDED|95.0|-8.56|-0.16|||MMRM model|||Mean of Week 40 to Week 52||-0.16|-8.56|
70954595|NCT04679935|141412138|OTHER|Analysis was purely descriptive.|Difference|-4.19|STANDARD_ERROR_OF_MEAN|2.28|||TWO_SIDED|95.0|-8.77|-0.39|||MMRM model|||Week 52||-0.39|-8.77|
71145952|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.26|TWO_SIDED|95.0|-0.18|0.67||P-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.||0.67|-0.18|0.260
71145953|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.141|TWO_SIDED|95.0|-0.76|0.11||P-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.||0.11|-0.76|0.141
71145954|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.007|TWO_SIDED|95.0|-0.98|-0.16||P-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.||-0.16|-0.98|0.007
70954599|NCT04362189|141412178|SUPERIORITY||Slope|-1.93|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
70954600|NCT04362189|141412179|SUPERIORITY||Slope|-1.31|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|||||
70954601|NCT04362189|141412180|SUPERIORITY||Slope|1.36|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
70954602|NCT04362189|141412181|SUPERIORITY||Slope|0.23|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
70954603|NCT04362189|141412182|SUPERIORITY||Slope|-0.15|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
70954604|NCT04362189|141412183|SUPERIORITY||Odds Ratio (OR)|0.2|||||TWO_SIDED||||||||HB-adMSCs represents Numerator and Placebo represents Denominator.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
70954605|NCT04362189|141412190|SUPERIORITY||Slope|-0.17|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
70954606|NCT04362189|141412191|SUPERIORITY||Slope|0.55|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
70954607|NCT04362189|141412192|SUPERIORITY||Slope|0.26|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
70954608|NCT04362189|141412193|SUPERIORITY||Slope|0.81|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
71145955|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.409|TWO_SIDED|95.0|-0.61|0.25||P-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.||0.25|-0.61|0.409
71145956|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.715|TWO_SIDED|95.0|-0.51|0.35||P-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.||0.35|-0.51|0.715
71145957|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.641|TWO_SIDED|95.0|-0.32|0.52||P-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.||0.52|-0.32|0.641
70873120|NCT00411645|141231685|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.979||||0.904|TWO_SIDED|95.0|0.697|1.375||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of CMV DNA PCR assay||1.375|0.697|0.904
71145958|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.767|TWO_SIDED|95.0|-0.64|0.47||P-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.||0.47|-0.64|0.767
70873121|NCT00411645|141231685|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.838||||0.289|TWO_SIDED|95.0|0.606|1.161||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of pp65 antigenemia or CMV DNA PCR assay||1.161|0.606|0.289
70873122|NCT00411645|141231685|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.891||||0.493|TWO_SIDED|95.0|0.64|1.239||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of initiation of anti-CMV therapy||1.239|0.640|0.493
71145959|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.881|TWO_SIDED|95.0|-0.61|0.52||P-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.||0.52|-0.61|0.881
70873123|NCT00411645|141231686|SUPERIORITY_OR_OTHER_LEGACY|||||||0.129|TWO_SIDED||||||Log Rank|||||||0.129
70873124|NCT00411645|141231686|SUPERIORITY_OR_OTHER_LEGACY||Adjusted hazard ratio|0.83||||0.13|TWO_SIDED|95.0|0.65|1.06||The p-value from Wald Chi-Square test for treatment effect.|Wald Chi-squared||Maribavir versus placebo; based on Cox's proportional hazards regression model: time = recipient CMV serostatus (R+ or R-) + transplant type (myeloablative or non-myeloablative/reduced intensity) + treatment.|||1.06|0.65|0.130
70873125|NCT00411645|141231687|SUPERIORITY_OR_OTHER_LEGACY|||||||0.542|TWO_SIDED|||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel|||Analysis of 100 days post-transplant||||0.542
70873126|NCT00411645|141231687|SUPERIORITY_OR_OTHER_LEGACY|||||||0.637|TWO_SIDED|||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel|||Analysis of 6 months post-transplant||||0.637
70873127|NCT00411645|141231687|SUPERIORITY_OR_OTHER_LEGACY|||||||0.825|TWO_SIDED|||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel|||Analysis of 12 months post-transplant||||0.825
70873128|NCT00411645|141231688|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.669||||0.022|TWO_SIDED|95.0|0.474|0.946||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of pp65 antigenemia assay||0.946|0.474|0.022
70873129|NCT00411645|141231688|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.878||||0.468|TWO_SIDED|95.0|0.617|1.247||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of CMV DNA PCR assay||1.247|0.617|0.468
70873130|NCT00411645|141231688|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.772||||0.125|TWO_SIDED|95.0|0.555|1.075||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of pp65 antigenemia assay or CMV DNA PCR assay||1.075|0.555|0.125
70873131|NCT00411645|141231688|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.731||||0.069|TWO_SIDED|95.0|0.521|1.026||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of initiation of anti-CMV therapy||1.026|0.521|0.069
70873132|NCT00411645|141231688|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.913||||0.86|TWO_SIDED|95.0|0.332|2.508||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of EC-confirmed disease||2.508|0.332|0.860
70873133|NCT00411645|141231689|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.835||||0.617|TWO_SIDED|95.0|0.411|1.693||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of 12 months post-transplant||1.693|0.411|0.617
70873134|NCT00411645|141231690|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.048||||0.7808|TWO_SIDED|95.0|0.754|1.457||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R -) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of 100 days post-transplant||1.457|0.754|0.7808
70873135|NCT00411645|141231690|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.068||||0.6946|TWO_SIDED|95.0|0.771|1.479||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R -) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of 6 months post-transplant||1.479|0.771|0.6946
70873136|NCT00411645|141231691|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.186||||0.6304|TWO_SIDED|95.0|0.592|2.375||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R -) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of 100 days post-transplant||2.375|0.592|0.6304
70873137|NCT00411645|141231691|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.726||||0.1019|TWO_SIDED|95.0|0.495|1.066||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R -) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of 6 months post-transplant||1.066|0.495|0.1019
71145960|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.885|TWO_SIDED|95.0|-0.51|0.59||p-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.||0.59|-0.51|0.885
71145961|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.325|TWO_SIDED|95.0|-0.96|0.32||P-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.||0.32|-0.96|0.325
71145962|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.798|TWO_SIDED|95.0|-0.73|0.56||P-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.||0.56|-0.73|0.798
71145963|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.461|TWO_SIDED|95.0|-0.39|0.87||p-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.||0.87|-0.39|0.461
71145964|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.67|TWO_SIDED|95.0|-1.02|0.66||p-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.||0.66|-1.02|0.670
71145965|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.243|TWO_SIDED|95.0|-1.37|0.35||P-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.||0.35|-1.37|0.243
71145966|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.423|TWO_SIDED|95.0|-1.14|0.48||P-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.||0.48|-1.14|0.423
71145967|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.333|TWO_SIDED|95.0|-1.04|0.35||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.||0.35|-1.04|0.333
71145968|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.334|TWO_SIDED|95.0|-1.05|0.36||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.||0.36|-1.05|0.334
71145969|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED|95.0|-0.69|0.68||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.||0.68|-0.69|0.990
70873138|NCT03143894|141231695|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.47|TWO_SIDED||||||t-test, 2 sided|||||||0.47
70873139|NCT03143894|141231696|SUPERIORITY||Mean Difference (Net)|0.69||||0.69|TWO_SIDED||||||t-test, 2 sided|||||||0.69
70873140|NCT03143894|141231697|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.36|TWO_SIDED||||||t-test, 2 sided|||||||0.36
70873141|NCT03521934|141231702|SUPERIORITY||Hazard Ratio (HR)|0.67|||<|0.001|TWO_SIDED|95.0|0.52|0.85|||Cox proportional hazards model|||The estimates of the hazard ratio (HR) and corresponding 2-sided 95% confidence interval (CI) was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-cardiovascular (non-CV) death treated as a competing event.||0.85|0.52|< 0.001
70873142|NCT03521934|141231703|SUPERIORITY||Hazard Ratio (HR)|0.64|||<|0.001|TWO_SIDED|95.0|0.49|0.83|||Cox proportional hazards model|||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.83|0.49|< 0.001
70873143|NCT03521934|141231704|SUPERIORITY||Hazard Ratio (HR)|0.84|||=|0.36|TWO_SIDED|95.0|0.58|1.22|||Cox proportional hazards model|||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||1.22|0.58|= 0.36
70873144|NCT03521934|141231705|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.56|0.92||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.92|0.56|
70873145|NCT03521934|141231706|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.54|0.86||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.86|0.54|
70873146|NCT03521934|141231707|SUPERIORITY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.59|1.14||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction.||1.14|0.59|
70873147|NCT03521934|141231708|SUPERIORITY||Hazard Ratio (HR)|4.1|||||TWO_SIDED|95.0|1.3|7.0||||||The change from baseline to Month 4 was analyzed using an ANCOVA model with treatment groups as factor and baseline KCCQ-12 score and randomization stratification factors as covariates.||7|1.3|
70873148|NCT03521934|141231709|SUPERIORITY||Difference in Least Squares Means|-0.16|||||TWO_SIDED|95.0|-1.3|0.98||||||Rate of decline in eGFR observed over time was analyzed by MMRM with absolute change in eGFR from baseline as the outcome, a random effect for intercept, and fixed effects for treatment, baseline value, and time.||0.98|-1.3|
70873149|NCT04294472|141231780|SUPERIORITY|Cohort 1 vs Placebo||||||0.1866|||||||Log Rank|||||||0.1866
70873150|NCT04294472|141231780|SUPERIORITY|Cohort 2 vs Placebo||||||0.2627|||||||Log Rank|||||||0.2627
70873151|NCT04294472|141231781|SUPERIORITY|Cohort 1 vs Placebo||||||0.0639|||||||Log Rank|||||||0.0639
70873152|NCT04294472|141231781|SUPERIORITY|Cohort 2 vs Placebo||||||0.0508|||||||Log Rank|||||||0.0508
70873153|NCT01049308|141231858|SUPERIORITY_OR_OTHER||percentage|57.6|||||TWO_SIDED|||||||||Descriptive data to describe prevalence of cognitive impairment in outpatient veterans with chronic heart failure||||
71145970|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.665|TWO_SIDED|95.0|-0.7|1.09||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.||1.09|-0.70|0.665
71145971|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.7|TWO_SIDED|95.0|-1.1|0.74||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.||0.74|-1.10|0.700
70873154|NCT02289417|141231860|SUPERIORITY||Stratified Difference|19.2||||0.0142|TWO_SIDED|95.0|3.4|33.6|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of oral (PO) corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||33.6|3.4|0.0142
71145972|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.386|TWO_SIDED|95.0|-1.23|0.48||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.||0.48|-1.23|0.386
71145973|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.12|TWO_SIDED|95.0|-1.27|0.15||P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.||0.15|-1.27|0.120
71145974|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.119|TWO_SIDED|95.0|-1.29|0.15||P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.||0.15|-1.29|0.119
71145975|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.976|TWO_SIDED|95.0|-0.71|0.69||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.||0.69|-0.71|0.976
71145976|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17||||0.026|TWO_SIDED|95.0|0.14|2.2||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.||2.20|0.14|0.026
71145977|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.36||||0.497|TWO_SIDED|95.0|-0.69|1.42||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.||1.42|-0.69|0.497
71145978|NCT00385671|141785550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.112|TWO_SIDED|95.0|-1.8|0.19||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.||0.19|-1.80|0.112
71145979|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.486||95.0||||P-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.486
71145980|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.983||95.0||||P-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.983
71145981|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.411||95.0||||p-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.411
71145982|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.554||95.0||||p-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.554
71145983|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.128||95.0||||p-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.128
71145984|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.488||95.0||||p-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.488
71145985|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.226||95.0||||p-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.226
71145986|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.71||95.0||||p-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.710
71145987|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||p-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.133
71145988|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.257||95.0||||p-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.257
71145989|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.412||95.0||||p-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.412
71145990|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||p-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.030
71145991|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||p-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.024
71145992|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||p-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.250
71145993|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.489||95.0||||p-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.489
71145994|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.682||95.0||||p-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.682
71145995|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.953||95.0||||p-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.953
71145996|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.803||95.0||||p-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.803
71145997|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.694||95.0||||p-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.694
71145998|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.835||95.0||||p-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.835
71145999|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.435||95.0||||p-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.435
71146000|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.379||95.0||||p-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.379
71146001|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.247||95.0||||p-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.247
71146002|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.784||95.0||||p-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.784
71146003|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.696||95.0||||p-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.696
70873155|NCT02289417|141231860|SUPERIORITY||Stratified Difference|7.7||||0.2689|TWO_SIDED|95.0|-6.9|22.0|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method|||22.0|-6.9|0.2689
70873156|NCT02289417|141231861|SUPERIORITY||Stratified Difference|14.6||||0.1224|TWO_SIDED|95.0|-3.6|31.5|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||31.5|-3.6|0.1224
70873157|NCT02289417|141231861|SUPERIORITY||Stratified Difference|19.4||||0.0401|TWO_SIDED|95.0|1.1|36.0|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||36.0|1.1|0.0401
70873158|NCT02289417|141231862|SUPERIORITY||Stratified Difference|5.2||||0.2472|TWO_SIDED|95.0|-5.7|16.7|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||16.7|-5.7|0.2472
70873159|NCT02289417|141231862|SUPERIORITY||Stratified Difference|3.1||||0.4628|TWO_SIDED|95.0|-7.5|14.6|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||14.6|-7.5|0.4628
70873160|NCT02289417|141231863|SUPERIORITY||Stratified Difference|32.0||||0.0005|TWO_SIDED|95.0|13.8|47.4|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||47.4|13.8|0.0005
70873161|NCT02289417|141231863|SUPERIORITY||Stratified Difference|3.7||||0.6878|TWO_SIDED|95.0|-14.4|21.5|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||21.5|-14.4|0.6878
70873162|NCT02289417|141231864|SUPERIORITY||Stratified Difference|11.5||||0.1388|TWO_SIDED|95.0|-4.1|26.1|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||26.1|-4.1|0.1388
70873163|NCT02289417|141231864|SUPERIORITY||Stratified Difference|13.5||||0.0788|TWO_SIDED|95.0|-1.6|27.7||Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Cochran-Mantel-Haenszel||Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||27.7|-1.6|0.0788
70873164|NCT02289417|141231865|SUPERIORITY||Stratified Difference|24.8||||0.0046|TWO_SIDED|95.0|7.5|40.1|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||40.1|7.5|0.0046
70873165|NCT02289417|141231865|SUPERIORITY||Stratified Difference|6.0||||0.4476||95.0|-9.8|21.6|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||21.6|-9.8|0.4476
70873166|NCT02289417|141231866|SUPERIORITY||Stratified Difference|16.7||||0.0755|TWO_SIDED|95.0|-1.4|33.5|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||33.5|-1.4|0.0755
70873167|NCT02289417|141231866|SUPERIORITY||Stratified Difference|19.8||||0.037|TWO_SIDED|95.0|1.5|36.4|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||36.4|1.5|0.0370
70873168|NCT02289417|141231867|SUPERIORITY||Stratified Difference|14.6||||0.1167|TWO_SIDED|95.0|-3.3|31.4|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||31.4|-3.3|0.1167
70873169|NCT02289417|141231867|SUPERIORITY||Stratified Difference|18.1||||0.0534|TWO_SIDED|95.0|-0.3|34.9|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||34.9|-0.3|0.0534
70954649|NCT05116540|141412284|SUPERIORITY||Mean Difference (Final Values)|22.121|STANDARD_ERROR_OF_MEAN|4.616||0.0002|TWO_SIDED|95.0|12.282|31.959|||ANCOVA|||||31.959|12.282|0.0002
71146004|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.725||95.0||||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.725
71146005|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.899||95.0||||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.899
70954650|NCT05116540|141412285|SUPERIORITY||Mean Difference (Final Values)|15.764|STANDARD_ERROR_OF_MEAN|5.844||0.0166|TWO_SIDED|95.0|3.307|28.221|||ANCOVA|||||28.221|3.307|0.0166
70954651|NCT05116540|141412286|SUPERIORITY||Mean Difference (Final Values)|22.137|STANDARD_DEVIATION|4.962||0.9905|TWO_SIDED|95.0|12.361|32.006|||ANCOVA|||||32.006|12.361|0.9905
70954652|NCT05116540|141412287|SUPERIORITY||Mean Difference (Final Values)|15.747|STANDARD_DEVIATION|6.274||0.8292|TWO_SIDED|95.0|3.329|28.177|||ANCOVA|||||28.177|3.329|0.8292
70954653|NCT05116540|141412288|SUPERIORITY||Mean Difference (Final Values)|-1.554|STANDARD_ERROR_OF_MEAN|0.638||0.0278|TWO_SIDED|95.0|-2.914|-0.195|||ANCOVA|||||-0.195|-2.914|0.0278
70954654|NCT05116540|141412289|SUPERIORITY||Mean Difference (Final Values)|5.453|STANDARD_ERROR_OF_MEAN|2.757||0.0666|TWO_SIDED|95.0|-0.424|11.33|||ANCOVA|||||11.330|-0.424|0.0666
70954655|NCT05116540|141412290|SUPERIORITY||Mean Difference (Final Values)|10.112|STANDARD_ERROR_OF_MEAN|5.508||0.0863|TWO_SIDED|95.0|-1.629|21.853|||ANCOVA|||||21.853|-1.629|0.0863
70954656|NCT05116540|141412291|SUPERIORITY||Mean Difference (Final Values)|0.977|STANDARD_ERROR_OF_MEAN|1.633||0.5588|TWO_SIDED|95.0|-2.504|4.457|||ANCOVA|||||4.457|-2.504|0.5588
70954657|NCT05116540|141412292|SUPERIORITY||Mean Difference (Final Values)|-4.593|STANDARD_ERROR_OF_MEAN|1.023||0.0004|TWO_SIDED|95.0|-6.773|-2.413|||ANCOVA|||||-2.413|-6.773|0.0004
70954658|NCT04348435|141412340|SUPERIORITY||Mean Difference (Net)|0.253|STANDARD_ERROR_OF_MEAN|0.49||0.6113|TWO_SIDED|95.0|||||ANCOVA|||||||0.6113
70954659|NCT04348435|141412340|SUPERIORITY||Mean Difference (Net)|-0.434|STANDARD_ERROR_OF_MEAN|0.638||0.5039|TWO_SIDED|95.0|||||ANCOVA|||||||0.5039
70954660|NCT04348435|141412340|SUPERIORITY||Mean Difference (Net)|0.077|STANDARD_ERROR_OF_MEAN|0.555||0.8903|TWO_SIDED|95.0|||||ANCOVA|||||||0.8903
70954661|NCT04348435|141412341|SUPERIORITY||Mean Difference (Net)|-0.247|STANDARD_ERROR_OF_MEAN|1.056||0.8171|TWO_SIDED|95.0|||||ANCOVA|||||||0.8171
70954662|NCT04348435|141412341|SUPERIORITY||Mean Difference (Net)|-0.913|STANDARD_ERROR_OF_MEAN|1.342||0.5034|TWO_SIDED|95.0|||||ANCOVA|||||||0.5034
70954663|NCT04348435|141412341|SUPERIORITY||Mean Difference (Net)|0.008|STANDARD_ERROR_OF_MEAN|1.193||0.9948|TWO_SIDED|95.0|||||ANCOVA|||||||0.9948
70954664|NCT04348435|141412342|SUPERIORITY||Mean Difference (Net)|0.179|STANDARD_ERROR_OF_MEAN|0.156||0.2641|TWO_SIDED|95.0|||||ANCOVA|||||||0.2641
70954665|NCT04348435|141412342|SUPERIORITY||Mean Difference (Net)|-0.045|STANDARD_ERROR_OF_MEAN|0.198||0.822|TWO_SIDED|95.0|||||ANCOVA|||||||0.8220
70954666|NCT04348435|141412342|SUPERIORITY||Median Difference (Net)|0.178|STANDARD_ERROR_OF_MEAN|0.171||0.3097|TWO_SIDED|95.0|||||ANCOVA|||||||0.3097
70954667|NCT04348435|141412343|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.07||1|TWO_SIDED|95.0|||||ANCOVA|||||||1.000
70954668|NCT04348435|141412343|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.087||1|TWO_SIDED|95.0|||||ANCOVA|||||||1.000
70954669|NCT04348435|141412343|SUPERIORITY||Mean Difference (Net)|0.112|STANDARD_ERROR_OF_MEAN|0.079||0.1713|TWO_SIDED|95.0|||||ANCOVA|||||||0.1713
70954670|NCT04348435|141412344|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.091||0.3868|TWO_SIDED|95.0|||||ANCOVA|||||||0.3868
70954671|NCT04348435|141412344|SUPERIORITY||Mean Difference (Net)|-0.008|STANDARD_ERROR_OF_MEAN|0.115||0.9429|TWO_SIDED|95.0|||||ANCOVA|||||||0.9429
70954672|NCT04348435|141412344|SUPERIORITY||Mean Difference (Net)|-0.008|STANDARD_ERROR_OF_MEAN|0.103||0.9362|TWO_SIDED|95.0|||||ANCOVA|||||||0.9362
70954673|NCT04348435|141412345|SUPERIORITY||Mean Difference (Net)|-0.708|STANDARD_ERROR_OF_MEAN|8.38||0.9333|TWO_SIDED|95.0|||||ANCOVA|||Average Energy/Fatigue - Treatment Contrast||||0.9333
70954674|NCT04348435|141412345|SUPERIORITY||Mean Difference (Net)|8.78|STANDARD_ERROR_OF_MEAN|9.483||0.3627|TWO_SIDED|95.0|||||ANCOVA|||Average Energy/Fatigue - Treatment Contrast||||0.3627
70954675|NCT04348435|141412345|SUPERIORITY||Mean Difference (Net)|6.282|STANDARD_ERROR_OF_MEAN|7.604||0.416|TWO_SIDED|95.0|||||ANCOVA|||Average Energy/Fatigue - Treatment Contrast||||0.4160
71146006|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.782||95.0||||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.782
71146007|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.307||95.0||||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.307
71146008|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.457
71146009|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.712||95.0||||P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.712
71146010|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.403||95.0||||P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.403
71146011|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.713||95.0||||P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.713
71146012|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.498
71146013|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.963||95.0||||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.963
71146014|NCT00385671|141785551|SUPERIORITY_OR_OTHER|||||||0.338||95.0||||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.338
71146015|NCT00385671|141785552|SUPERIORITY_OR_OTHER|||||||0.645||95.0||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Total Score.||||0.645
71146016|NCT00385671|141785552|SUPERIORITY_OR_OTHER|||||||0.248||95.0||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Total Score.||||0.248
71146017|NCT00385671|141785552|SUPERIORITY_OR_OTHER|||||||0.47||95.0||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Total Score.||||0.470
70873170|NCT02289417|141231868|SUPERIORITY||Stratified Difference|16.6||||0.0758|TWO_SIDED|95.0|-1.5|33.3|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||33.3|-1.5|0.0758
70873171|NCT02289417|141231868|SUPERIORITY||Stratified Difference|32.5||||0.0004|TWO_SIDED|95.0|14.9|47.5|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||47.5|14.9|0.0004
70873172|NCT04786990|141231875|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
70873173|NCT04786990|141231875|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
70873174|NCT04786990|141231876|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
70873175|NCT04786990|141231876|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
70873176|NCT04786990|141231878|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
70873177|NCT04786990|141231878|OTHER|||||||0.0002||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||0.0002
71146018|NCT00385671|141785552|SUPERIORITY_OR_OTHER|||||||0.914||95.0||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Cognitive Toxicity Score.||||0.914
71146019|NCT00385671|141785552|SUPERIORITY_OR_OTHER|||||||0.505||95.0||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Cognitive Toxicity Score.||||0.505
71146020|NCT00385671|141785552|SUPERIORITY_OR_OTHER|||||||0.57||95.0||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Cognitive Toxicity Score.||||0.570
71146021|NCT00385671|141785552|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Somatomotor Toxicity Score.||||0.430
71146022|NCT00385671|141785552|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Somatomotor Toxicity Score.||||0.090
70873178|NCT04786990|141231879|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
70873179|NCT04786990|141231879|OTHER||||||<|0.0001||||||The p-value generated for the comparison between time points for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed. There is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
70873180|NCT04786990|141231880|OTHER|||||||0.0685||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||0.0685
70873181|NCT04786990|141231880|OTHER|||||||0.2575||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data|t-test, 2 sided|||Week 8||||0.2575
70873182|NCT04786990|141231881|OTHER|||||||0.0832||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||0.0832
70873183|NCT04786990|141231881|OTHER|||||||0.3715||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||0.3715
70873184|NCT04786990|141231882|OTHER|||||||0.0042||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data|t-test, 2 sided|||Week 4||||0.0042
70873185|NCT04786990|141231882|OTHER|||||||0.0019||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||0.0019
70873186|NCT04786990|141231883|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data|t-test, 2 sided|||Week 4||||<0.0001
70873187|NCT04786990|141231883|OTHER|||||||0.0025||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data|t-test, 2 sided|||Week 8||||0.0025
70873188|NCT04786990|141231884|OTHER|||||||0.0161||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||0.0161
70873189|NCT04786990|141231884|OTHER|||||||0.0122||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||0.0122
70873190|NCT04786990|141231885|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
70873191|NCT04786990|141231885|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
70873192|NCT04786990|141231886|OTHER|||||||0.0002||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||0.0002
70873193|NCT04786990|141231886|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
70873194|NCT04786990|141231887|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
70873195|NCT04786990|141231887|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
70873196|NCT04786990|141231888|OTHER|||||||0.0005||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.0005
70873197|NCT04786990|141231889|OTHER|||||||0.0005||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.0005
70873198|NCT04786990|141231890|OTHER|||||||0.0016||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.0016
70873199|NCT04786990|141231891|OTHER|||||||0.89||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.8900
70873200|NCT04786990|141231892|OTHER|||||||0.3269||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.3269
70873201|NCT04786990|141231893|OTHER|||||||0.5085||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.5085
70873202|NCT04786990|141231894|OTHER|||||||0.3484||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.3484
70873203|NCT04786990|141231895|OTHER|||||||0.4385||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.4385
70873204|NCT04786990|141231896|OTHER|||||||0.5073||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.5073
70873205|NCT04786990|141231897|OTHER|||||||0.9119||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.9119
70873206|NCT04786990|141231898|OTHER|||||||0.014||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.0140
70954676|NCT04348435|141412345|SUPERIORITY||Mean Difference (Net)|0.52|STANDARD_ERROR_OF_MEAN|3.32||0.8768|TWO_SIDED|95.0|||||ANCOVA|||Average Social Functioning - Treatment Contrast||||0.8768
71146023|NCT00385671|141785552|SUPERIORITY_OR_OTHER|||||||0.341||95.0||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Somatomotor Toxicity Score.||||0.341
71146024|NCT00385671|141785553|SUPERIORITY_OR_OTHER|||||||0.13||95.0||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale total score.||||0.130
71146025|NCT00385671|141785553|SUPERIORITY_OR_OTHER|||||||0.192||95.0||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale total score.||||0.192
71146026|NCT00385671|141785553|SUPERIORITY_OR_OTHER|||||||0.936||95.0||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale total score.||||0.936
71146027|NCT00385671|141785553|SUPERIORITY_OR_OTHER|||||||0.48||95.0||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale cognitive toxicity score.||||0.480
71146028|NCT00385671|141785553|SUPERIORITY_OR_OTHER|||||||0.69||95.0||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale cognitive toxicity score.||||0.690
71146029|NCT00385671|141785553|SUPERIORITY_OR_OTHER|||||||0.923||95.0||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale cognitive toxicity score.||||0.923
71146030|NCT00385671|141785553|SUPERIORITY_OR_OTHER|||||||0.202||95.0||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale somatomotor toxicity score.||||0.202
71146031|NCT00385671|141785553|SUPERIORITY_OR_OTHER|||||||0.114||95.0||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale somatomotor toxicity score.||||0.114
71146032|NCT00385671|141785553|SUPERIORITY_OR_OTHER|||||||0.954||95.0||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale somatomotor toxicity score.||||0.954
71146033|NCT00385671|141785554|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||P-value for Direct Treatment Effect. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for tests of direct and indirect effects.|Regression, Linear|||||||0.107
71146034|NCT00385671|141785555|SUPERIORITY_OR_OTHER|||||||0.968||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BDI-II total score.||||0.968
71146035|NCT00385671|141785555|SUPERIORITY_OR_OTHER|||||||0.492||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BDI-II total score.||||0.492
70873207|NCT04786990|141231899|OTHER|||||||0.1542||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.1542
70873208|NCT04786990|141231900|OTHER|||||||0.0086||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.0086
70873209|NCT04786990|141231901|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
70873210|NCT04786990|141231901|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
70873211|NCT04786990|141231902|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
70873212|NCT04786990|141231902|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
70873213|NCT04786990|141231903|OTHER|||||||0.5582||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||"Week 4; Morning PR-ADHD-RS-5 Total score versus Evening PR-ADHD-RS-5 Total score"||||0.5582
70873214|NCT04786990|141231904|OTHER|||||||0.5061||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||"Week 8; Morning PR-ADHD-RS-5 Total score versus Evening PR-ADHD-RS-5 Total score"||||0.5061
70873215|NCT00923247|141231916|SUPERIORITY_OR_OTHER|||||||0.019|||||||Mann-Whitney|(nonparametric unpaired t-test; assumed homoscedasticity)||Patients given bortezomib on cycle 1, day 1 vs. cycle 3, day 1. A paired analysis among same 14 patients on Phase 1 portion. To assess whether presence of vandetanib significantly altered bortezomib Cmax (normalized to dose).||||0.019
70873216|NCT00923247|141231917|SUPERIORITY_OR_OTHER|||||||0.052|||||||Mann-Whitney|(nonparametric unpaired t-test; assumed homoscedasticity)||Patients given bortezomib on cycle 1 day 1 vs. cycle 3 day 1. A paired analysis among same 14 patients on Phase 1 portion. To assess whether presence of vandetanib significantly altered bortezomib AUCinf (normalized to dose).||||0.052
70873217|NCT00923247|141231918|SUPERIORITY_OR_OTHER|||||||0.44|||||||Mann-Whitney|(nonparametric unpaired t-test; assumed homoscedasticity)||Patients given bortezomib on cycle 1 day 1 vs. cycle 3 day 1. A paired analysis among same 14 patients on Phase 1 portion. To assess whether presence of vandetanib significantly altered bortezomib half-life.||||0.440
70873218|NCT00923247|141231919|SUPERIORITY_OR_OTHER|||||||0.016|||||||Mann-Whitney|(nonparametric unpaired t-test; assumed homoscedasticity)||Patients given bortezomib on cycle 1 day 1 vs. cycle 3 day 1. A paired analysis among same 14 patients on Phase 1 portion. To assess whether presence of vandetanib significantly altered bortezomib clearance.||||0.016
70873219|NCT00923247|141231920|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mann-Whitney|(nonparametric unpaired t-test; assumed homoscedasticity)||Patients given bortezomib on cycle 1 day 1 vs. cycle 3 day 1. A paired analysis among same 14 patients on Phase I portion. To assess whether presence of vandetanib significantly altered bortezomib volume of distribution.||||0.010
70873220|NCT01782222|141231922|SUPERIORITY_OR_OTHER||Least Square Mean|0.04|STANDARD_ERROR_OF_MEAN|1.24||0.977|TWO_SIDED|95.0|-2.42|2.5|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||2.50|-2.42|0.977
70873221|NCT01782222|141231922|SUPERIORITY_OR_OTHER||Least Square Mean|-0.22|STANDARD_ERROR_OF_MEAN|1.21||0.859|TWO_SIDED|95.0|-2.61|2.18|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||2.18|-2.61|0.859
70873222|NCT01782222|141231923|SUPERIORITY_OR_OTHER||Least Square Mean|-7.29|STANDARD_ERROR_OF_MEAN|2.53||0.005|TWO_SIDED|95.0|-12.3|-2.28|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||-2.28|-12.30|0.005
70873223|NCT01782222|141231923|SUPERIORITY_OR_OTHER||Least Square Mean|-6.06|STANDARD_ERROR_OF_MEAN|2.45||0.015|TWO_SIDED|95.0|-10.9|-1.21|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||-1.21|-10.90|0.015
70873224|NCT01782222|141231924|SUPERIORITY_OR_OTHER||Least Square Mean|-3.2|STANDARD_ERROR_OF_MEAN|2.46||0.2|TWO_SIDED|95.0|-8.17|1.76|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||1.76|-8.17|0.200
70873225|NCT01782222|141231924|SUPERIORITY_OR_OTHER||Least Square Mean|-3.04|STANDARD_ERROR_OF_MEAN|2.55||0.239|TWO_SIDED|95.0|-8.19|2.1|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||2.10|-8.19|0.239
70873226|NCT01782222|141231925|SUPERIORITY_OR_OTHER||Least Square Mean|-2.09|STANDARD_ERROR_OF_MEAN|3.23||0.519|TWO_SIDED|95.0|-8.48|4.31|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||4.31|-8.48|0.519
70873227|NCT01782222|141231925|SUPERIORITY_OR_OTHER||Least Square Mean|-5.06|STANDARD_ERROR_OF_MEAN|3.15||0.111|TWO_SIDED|95.0|-11.29|1.17|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||1.17|-11.29|0.111
70873228|NCT01782222|141231926|SUPERIORITY_OR_OTHER||Least Square Mean|-3.62|STANDARD_ERROR_OF_MEAN|1.9||0.06|TWO_SIDED|95.0|-7.39|0.15|||ANCOVA|ANCOVA model for the change from Baseline to End of Treatment containing treatment and disease stage as factors, and Baseline value as covariate.||||0.15|-7.39|0.060
70873229|NCT01782222|141231926|SUPERIORITY_OR_OTHER||Least Square Mean|-3.88|STANDARD_ERROR_OF_MEAN|1.8||0.034|TWO_SIDED|95.0|-7.46|-0.3|||ANCOVA|ANCOVA model for the change from Baseline to End of Treatment containing treatment and disease stage as factors, and Baseline value as covariate.||||-0.30|-7.46|0.034
70873230|NCT01782222|141231927|SUPERIORITY_OR_OTHER||Least Square Mean|-0.38|STANDARD_ERROR_OF_MEAN|0.39||0.334|TWO_SIDED|95.0|-1.16|0.4|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||0.40|-1.16|0.334
70873231|NCT01782222|141231927|SUPERIORITY_OR_OTHER||Least Square Mean|0.02|STANDARD_ERROR_OF_MEAN|0.38||0.968|TWO_SIDED|95.0|-0.74|0.77|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||0.77|-0.74|0.968
70873232|NCT01782222|141231928|SUPERIORITY_OR_OTHER||Least Square Mean|0.16|STANDARD_ERROR_OF_MEAN|1.26||0.899|TWO_SIDED|95.0|-2.34|2.66|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||2.66|-2.34|0.899
70873233|NCT01782222|141231928|SUPERIORITY_OR_OTHER||Least Square Mean|-0.33|STANDARD_ERROR_OF_MEAN|1.19||0.785|TWO_SIDED|95.0|-2.68|2.03|||ANCOVA|ANCOVA model for the change from Baseline to End of Treatment containing treatment and disease stage as factors, and Baseline value as covariate.||||2.03|-2.68|0.785
70873234|NCT01782222|141231929|SUPERIORITY_OR_OTHER||Least Square Mean|-4.96|STANDARD_ERROR_OF_MEAN|1.99||0.014|TWO_SIDED|95.0|-8.91|-1.01|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||-1.01|-8.91|0.014
70873235|NCT01782222|141231929|SUPERIORITY_OR_OTHER||Least Square Mean|-4.83|STANDARD_ERROR_OF_MEAN|1.92||0.013|TWO_SIDED|95.0|-8.63|-1.03|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||-1.03|-8.63|0.013
70873236|NCT01897402|141232073|NON_INFERIORITY_OR_EQUIVALENCE|The assumptions for the sample size calculations were: 1) Seroconversion for the control vaccine (Menactra) is 40-80% and 2) the true treatments are theoretically equal and 3) the power of detecting non-inferiority is 90%.|Percentage Difference|0.6|||||TWO_SIDED|95.0|-7.9|9.1|||||Serogroup A|The hypothesis was that the test vaccine is comparable to the licensed active control vaccine. Differences between treatment groups were described using exact two-sided 95% confidence intervals on differences in % seroconversion between the two treatment groups (test vaccine minus reference vaccine) for each serogroup. If the lower bound of the difference is ≥ -15%, then the test vaccine meets the preliminary criterion for non-inferiority.||9.1|-7.9|
70873237|NCT01897402|141232073|NON_INFERIORITY_OR_EQUIVALENCE|The assumptions for the sample size calculations were: 1) Seroconversion for the control vaccine (Menactra) is 40-80% and 2) the true treatments are theoretically equal and 3) the power of detecting non-inferiority is 90%.|Percentage Difference|-6.0|||||TWO_SIDED|95.0|-14.6|2.6|||||Serogroup C|The hypothesis was that the test vaccine is comparable to the licensed active control vaccine. Differences between treatment groups were described using exact two-sided 95% confidence intervals on differences in % seroconversion between the two treatment groups (test vaccine minus reference vaccine) for each serogroup. If the lower bound of the difference is ≥ -15%, then the test vaccine meets the preliminary criterion for non-inferiority.||2.6|-14.6|
70873238|NCT01897402|141232073|NON_INFERIORITY_OR_EQUIVALENCE|The assumptions for the sample size calculations were: 1) Seroconversion for the control vaccine (Menactra) is 40-80% and 2) the true treatments are theoretically equal and 3) the power of detecting non-inferiority is 90%.|Percentage Difference|-1.0|||||TWO_SIDED|95.0|-9.9|7.9|||||Serogroup Y|The hypothesis was that the test vaccine is comparable to the licensed active control vaccine. Differences between treatment groups were described using exact two-sided 95% confidence intervals on differences in % seroconversion between the two treatment groups (test vaccine minus reference vaccine) for each serogroup. If the lower bound of the difference is ≥ -15%, then the test vaccine meets the preliminary criterion for non-inferiority.||7.9|-9.9|
70954677|NCT04348435|141412345|SUPERIORITY||Mean Difference (Net)|-7.719|STANDARD_ERROR_OF_MEAN|4.344||0.0869|TWO_SIDED|95.0|||||ANCOVA|||Average Social Functioning - Treatment Contrast||||0.0869
70954678|NCT04348435|141412345|SUPERIORITY||Mean Difference (Net)|1.434|STANDARD_ERROR_OF_MEAN|3.514||0.6864|TWO_SIDED|95.0|||||ANCOVA|||Average Social Functioning - Treatment Contrast||||0.6864
70954679|NCT04348435|141412345|SUPERIORITY||Mean Difference (Net)|-4.12|STANDARD_ERROR_OF_MEAN|3.571||0.2587|TWO_SIDED|95.0|||||ANCOVA|||Avg. Role Limitations Due to Physical Health - Treatment Contrast||||0.2587
70954680|NCT04348435|141412345|SUPERIORITY||Mean Difference (Net)|8.417|STANDARD_ERROR_OF_MEAN|5.316||0.125|TWO_SIDED|95.0|||||ANCOVA|||Avg. Role Limitations Due to Physical Health - Treatment Contrast||||0.1250
71146036|NCT00385671|141785555|SUPERIORITY_OR_OTHER|||||||0.463||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BDI-II total score.||||0.463
71146037|NCT00385671|141785558|SUPERIORITY_OR_OTHER|||||||0.103||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in time to first ≥ 30% reduction in weekly mean 24 hour average pain score.||||0.103
70873239|NCT01897402|141232073|NON_INFERIORITY_OR_EQUIVALENCE|The assumptions for the sample size calculations were: 1) Seroconversion for the control vaccine (Menactra) is 40-80% and 2) the true treatments are theoretically equal and 3) the power of detecting non-inferiority is 90%.|Percentage Difference|0.3|||||TWO_SIDED|95.0|-8.5|9.1|||||Serogroup W-135|The hypothesis was that the test vaccine is comparable to the licensed active control vaccine. Differences between treatment groups were described using exact two-sided 95% confidence intervals on differences in % seroconversion between the two treatment groups (test vaccine minus reference vaccine) for each serogroup. If the lower bound of the difference is ≥ -15%, then the test vaccine meets the preliminary criterion for non-inferiority.||9.1|-8.5|
70873240|NCT02634320|141232077|OTHER|Statistical test is to confirm the change from baseline is statistically different from 0.||||||0.078||||||Change from baseline at last on-treatment visit|t-test, 2 sided|||||||0.078
70873241|NCT01209260|141232095|SUPERIORITY_OR_OTHER|||||||0.005||||||Statistical tests were 2-sided and considered significant if they yielded a p\<0.05|t-test, 2 sided|||Sample size of 72 was targeted to achieve 80% power to detect a 5-minute reduction in transseptal access procedure time (assuming a standard deviation of 7.5 minutes), using a 2-sided alpha of 0.05, with the primary analysis done on an intention-to-treat basis.||||0.005
70873242|NCT01209260|141232097|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical tests were 2-sided and considered significant if they yielded a p\<0.05|Chi-squared|||||||<0.001
70873243|NCT01209260|141232098|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical tests were 2-sided and considered significant if they yielded a p\<0.05.|Chi-squared|||||||<0.001
70873244|NCT01179568|141232113|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.21|||<|0.05|TWO_SIDED|95.0|0.82|1.81|||Regression, Logistic|Logistic regression with inverse probability weighting controlled for randomization stratification variables (site and baseline MDD) \& race/ethnicity||Our prespecified primary analysis was cross-sectional, comparing treatment response rates for CIT vs PLA at week 12 (aim 1), based on the intention-to-treat principle including all randomized participants. With 10% of 440 target enrollment lost to follow-up we had a power of 76-83% to detect predicted between-group difference in response (CGT with PLA, 40%; CGT with CIT, 60%; CIT 40%; and PLA 20%)||1.81|0.82|<0.05
70873245|NCT01179568|141232113|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.01|||<|0.05|TWO_SIDED|95.0|0.88|1.17|||Regression, Logistic|Logistic regression with inverse probability weighting controlled for randomization stratification variables (site and baseline MDD) \& race/ethnicity||Our prespecified primary analysis was cross-sectional, comparing treatment response rates for CIT with CGT vs PLA with CGT at week 20 (aim 2) based on the intention-to-treat principle including all randomized participants.||1.17|0.88|<0.05
70873246|NCT01179568|141232113|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.21|||<|0.05|TWO_SIDED|95.0|1.0|1.46|||Regression, Logistic|Logistic regression with inverse probability weighting controlled for randomization stratification variables (site and baseline MDD) \& race/ethnicity||Our prespecified primary analysis was cross-sectional, comparing treatment response rates for CIT with CGT vs CIT at week 20 (aim 3) based on the intention-to-treat principle including all randomized participants.||1.46|1|<0.05
70873247|NCT01179568|141232114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|2.04||0.74|TWO_SIDED|||||Pre-specified secondary analyses compared changes in ICG scores using a weighted linear regression, controlling for site, baseline MDD, \& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.|Regression, Linear|||||||0.74
70873248|NCT01179568|141232115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|STANDARD_ERROR_OF_MEAN|1.98||0.53|TWO_SIDED|||||Pre-specified secondary analyses compared changes in ICG scores using a weighted linear regression, controlling for site, baseline MDD, \& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.|Regression, Linear|||||||.53
70873249|NCT01179568|141232115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.37|STANDARD_ERROR_OF_MEAN|2.08|<|0.001|TWO_SIDED|||||Pre-specified secondary analyses compared changes in ICG scores using a weighted linear regression, controlling for site, baseline MDD, \& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.|Regression, Linear|||||||<.001
70873250|NCT01179568|141232116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|1.57||0.59|TWO_SIDED|||||Pre-specified secondary analyses compared changes in WSAS scores using a weighted linear regression, controlling for site, baseline MDD, \& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.|Regression, Linear|||||||.59
70873251|NCT01179568|141232117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.44||0.4|TWO_SIDED||||||Regression, Linear|||Pre-specified secondary analyses compared changes in WSAS scores using a weighted linear regression, controlling for site, baseline MDD, \& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.||||.40
70873252|NCT01179568|141232117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.13|STANDARD_ERROR_OF_MEAN|1.46||0.005|TWO_SIDED||||||Regression, Linear|||Pre-specified secondary analyses compared changes in WSAS scores using a weighted linear regression, controlling for site, baseline MDD, \& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.||||.005
70873253|NCT00357968|141232125|SUPERIORITY_OR_OTHER||Mean Difference (Net)|43.21|||<|0.0001|TWO_SIDED|95.0|38.04|48.38|||ANCOVA|||||48.38|38.04|<0.0001
70873254|NCT00357968|141232126|SUPERIORITY_OR_OTHER||LS Mean difference|14.93|||<|0.0001|TWO_SIDED|95.0|10.6|19.26|||Mixed Models Analysis|||||19.26|10.6|<0.0001
70873255|NCT00357968|141232127|SUPERIORITY_OR_OTHER||Mean Difference (Net)|44.75|||<|0.0001|TWO_SIDED|95.0|38.35|51.15|||ANCOVA|||||51.15|38.35|<0.0001
70873256|NCT00357968|141232132|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
70873257|NCT00357968|141232133|SUPERIORITY_OR_OTHER|||||||0.0629||95.0|||||Fisher Exact|||||||0.0629
70873258|NCT00357968|141232134|SUPERIORITY_OR_OTHER|||||||0.1827||95.0|||||Fisher Exact|||||||0.1827
70873259|NCT00357968|141232135|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-54.3|||<|0.0001|TWO_SIDED|95.0|-61.2|-47.4|||ANCOVA|||||-47.4|-61.2|<0.0001
70873260|NCT00357968|141232136|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-60.5|||<|0.0001|TWO_SIDED|95.0|-67.1|-54.0|||ANCOVA|||||-54.0|-67.1|<0.0001
70873261|NCT00357968|141232137|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-56.2|||<|0.0001|TWO_SIDED|95.0|-63.2|-49.2|||ANCOVA|||||-49.2|-63.2|<0.0001
70873262|NCT00357968|141232138|SUPERIORITY_OR_OTHER||LS Mean difference|-20.1|||<|0.0001|TWO_SIDED|95.0|-25.7|-14.5|||Mixed Models Analysis|||||-14.5|-25.7|<0.0001
70873263|NCT00357968|141232139|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.7058|TWO_SIDED|95.0|-2.95|2.0|||ANCOVA|||||2.00|-2.95|0.7058
70873264|NCT00357968|141232140|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.33||||0.4029|TWO_SIDED|95.0|-4.48|1.82|||ANCOVA|||||1.82|-4.48|0.4029
70873265|NCT00357968|141232141|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.7893|TWO_SIDED|95.0|-0.06|0.08|||ANCOVA|||||0.08|-0.06|0.7893
70873266|NCT00357968|141232142|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.4528|TWO_SIDED|95.0|-0.25|0.07|||ANCOVA|||||0.07|-0.25|0.4528
70873267|NCT04847557|141232148|SUPERIORITY||Median Difference (Net)|6.9|||<|0.001|TWO_SIDED|95.0|3.3|10.6|||Stratified Wilcoxon|Stratified Wilcoxon test used to control for stratification factors of HF decompensation within 12 months of screening,diagnosed T2DM \& baseline BMI|The Hodges-Lehmann estimate for the median difference and 95% CIs was reported.|||10.6|3.3|<0.001
70873268|NCT04847557|141232149|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.026|TWO_SIDED|95.0|0.41|0.95|||Regression, Cox|||Heart Failure Outcomes||0.95|0.41|0.026
70873269|NCT04847557|141232150|SUPERIORITY||Median Difference (Net)|18.3|||<|0.001|TWO_SIDED|95.0|9.9|26.7|||Stratified Wilcoxon|Stratified Wilcoxon test used to control for stratification factors of HF decompensation within 12 months of screening,diagnosed T2DM \& baseline BMI|The Hodges-Lehmann estimate for the median difference and 95% CIs was reported.|||26.7|9.9|<0.001
70873270|NCT04847557|141232151|SUPERIORITY||LS Mean Difference|-11.62|||<|0.001|TWO_SIDED|95.0|-12.85|-10.38|||ANCOVA|||||-10.38|-12.85|<0.001
70873271|NCT04847557|141232152|SUPERIORITY||LS Mean Difference|-34.91|||<|0.001|TWO_SIDED|95.0|-45.6|-22.17|||ANCOVA|||||-22.17|-45.60|<0.001
70873272|NCT04847557|141232153|SUPERIORITY||Win Ratio|1.63|||||TWO_SIDED|95.0|1.17|2.28|||||The win ratio was reported as the measure of treatment effect based on the principle that each participant is compared with every other participant within each stratum in a pair-wise manner that proceeds in a hierarchical fashion.|||2.28|1.17|
70873273|NCT04847557|141232154|SUPERIORITY||Odds Ratio (OR)|2.28|||||TWO_SIDED|95.0|1.53|3.4||||||||3.40|1.53|
70873274|NCT04847557|141232155|SUPERIORITY||Hazard Ratio (HR)|1.245|||||TWO_SIDED|95.0|0.633|2.452||||||||2.452|0.633|
70873275|NCT04847557|141232156|SUPERIORITY||Hazard Ratio (HR)|0.539|||||TWO_SIDED|95.0|0.342|0.85||||||||0.850|0.342|
70873276|NCT04847557|141232157|SUPERIORITY||Rate Ratio|0.72|||||TWO_SIDED|95.0|0.46|1.14||||||||1.14|0.46|
70873277|NCT04847557|141232158|SUPERIORITY||Rate Ratio|0.62|||||TWO_SIDED|95.0|0.37|1.05||||||||1.05|0.37|
70954681|NCT04348435|141412345|SUPERIORITY||Mean Difference (Net)|-0.104|STANDARD_ERROR_OF_MEAN|3.732||0.978|TWO_SIDED|95.0|||||ANCOVA|||Avg. Role Limitations Due to Physical Health - Treatment Contrast||||0.9780
70954682|NCT04348435|141412345|SUPERIORITY||Mean Difference (Net)|0.963|STANDARD_ERROR_OF_MEAN|5.925||0.8721|TWO_SIDED|95.0|||||ANCOVA|||Average General Health - Treatment Contrast||||0.8721
70954683|NCT04348435|141412345|SUPERIORITY||Mean Difference (Net)|3.34|STANDARD_ERROR_OF_MEAN|7.735||0.6694|TWO_SIDED|95.0|||||ANCOVA|||Average General Health - Treatment Contrast||||0.6694
71146038|NCT00385671|141785558|SUPERIORITY_OR_OTHER|||||||0.167||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in time to first ≥ 30% reduction in weekly mean 24 hour average pain score.||||0.167
70873278|NCT03758274|141232171|SUPERIORITY|||||||0.746|||||||Based on simple path model in Mplus.|||||||0.746
70873279|NCT03758274|141232172|SUPERIORITY|||||||0.247|||||||Based on simple path model in Mplus.|||||||0.247
70873280|NCT03758274|141232173|SUPERIORITY|||||||0.689|||||||Chi-squared|||||||0.689
70873281|NCT00842712|141232219|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.718||||0.0845|TWO_SIDED|95.0|0.492|1.048|||Log Rank|||PFS Time: Independent read||1.048|0.492|0.0845
70873282|NCT00842712|141232220|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.909||||0.5912|TWO_SIDED|95.0|0.642|1.286|||Log Rank|||||1.286|0.642|0.5912
70873283|NCT00842712|141232221|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.813||||0.2648|TWO_SIDED|95.0|0.564|1.171|||Log Rank|||||1.171|0.564|0.2648
70873284|NCT00875212|141232224|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5.5|STANDARD_DEVIATION|0.25||0.001||95.0|||||ANOVA|repeated measure anova|The median value of each parameter (pH baseline, minimal pH) was obtained and these values were compared between each group|The study was based on the use of dentifrices for daily oral hygiene in a crossover design. The null hyphothesis was no difference between pH values of the groups. The statistical analysis was by repeated measurements ANOVA.||||0.001
70873285|NCT00875212|141232224|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5.5|STANDARD_DEVIATION|0.1||0.001||95.0|||||ANOVA|repeated-measurements ANOVA||The comparison was based on mean and median values of plaque pH in different moments of cariogenic challenge. The null hypothesis was that no diference between the groups wil be found. The test hypothesis was that the experimental dentifrice of CaGP-F would provide a better control of plaque pH after 14 days of use.||||0.001
70873286|NCT00875212|141232225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5|STANDARD_DEVIATION|0.25||0.01||95.0|||||ANOVA|repeated measurements ANOVA|The difference of pH values between groups was above 1.0 unit.|The groups were compared by repeated measurements anova. There was no power calculation, but a pilot study to check the minimal number necessary of subjects in order to find a signifcant difference between interventions.||||0.01
70873287|NCT01549860|141232233|SUPERIORITY_OR_OTHER||||||<|0.024|TWO_SIDED||||||t-test, 2 sided|||||||<0.024
70873288|NCT01549860|141232235|SUPERIORITY_OR_OTHER||||||<|0.0126|TWO_SIDED|||||The MIST+SOC subjects decreased in their reported mean pain scores and reduced from a median of 3.0 to 0.6 cm after four weeks of study treatment.|ANCOVA|||||||<0.0126
70873289|NCT04677374|141232236|OTHER|||||||0.044|||||||Test of proportions|||||||0.044
70873290|NCT04677374|141232236|OTHER|||||||0.259|||||||Test of proportions|||||||0.259
70873291|NCT04677374|141232236|OTHER|||||||0.044|||||||Test of proportions|||||||0.044
70873292|NCT04677374|141232237|OTHER||Hazard Ratio (HR)|2.23|||||TWO_SIDED|95.0|1.01|4.93||||||||4.93|1.01|
70873293|NCT04677374|141232237|OTHER||Hazard Ratio (HR)|1.66|||||TWO_SIDED|95.0|0.69|4.0||||||||4.00|0.69|
70873294|NCT04677374|141232237|OTHER||Hazard Ratio (HR)|2.31|||||TWO_SIDED|95.0|1.0|5.36||||||||5.36|1.00|
70873295|NCT03975790|141232251|SUPERIORITY|||||||0.4695|||||||Chi-squared|||||||0.4695
70873296|NCT03975790|141232251|SUPERIORITY|||||||0.7644|||||||Chi-squared|||||||0.7644
70873297|NCT03975790|141232251|SUPERIORITY|||||||0.8316|||||||Chi-squared|||||||0.8316
70873298|NCT03975790|141232252|SUPERIORITY|||||||0.9829|||||||Chi-squared|||||||0.9829
70873299|NCT03975790|141232252|SUPERIORITY|||||||0.8021|||||||Chi-squared|||||||0.8021
70873300|NCT03975790|141232252|SUPERIORITY|||||||0.8376|||||||Chi-squared|||||||0.8376
70873301|NCT03975790|141232253|SUPERIORITY|||||||0.2864|||||||t-test|||||||0.2864
70873302|NCT03975790|141232253|SUPERIORITY|||||||0.1583|||||||t-test|||||||0.1583
70873303|NCT03975790|141232253|SUPERIORITY|||||||0.4546|||||||t-test|||||||0.4546
70873304|NCT03975790|141232254|SUPERIORITY|||||||0.028|||||||t-test|||||||0.0280
70873305|NCT03975790|141232254|SUPERIORITY|||||||0.0106|||||||t-test|||||||0.0106
70873306|NCT03975790|141232254|SUPERIORITY|||||||0.7293|||||||t-test|||||||0.7293
70873307|NCT03975790|141232255|SUPERIORITY|||||||0.9215|||||||Chi-squared|||||||0.9215
70873308|NCT03975790|141232255|SUPERIORITY|||||||0.6078|||||||Chi-squared|||||||0.6078
70873309|NCT03975790|141232255|SUPERIORITY|||||||0.6258|||||||Chi-squared|||||||0.6258
70873310|NCT03975790|141232256|SUPERIORITY|||||||0.3586|||||||Chi-squared|||||||0.3586
70873311|NCT03975790|141232256|SUPERIORITY|||||||0.5117|||||||Chi-squared|||||||0.5117
70873312|NCT03975790|141232257|SUPERIORITY|||||||0.5372|||||||t-test|||||||0.5372
70873313|NCT03975790|141232257|SUPERIORITY|||||||0.6155|||||||t-test|||||||0.6155
70873314|NCT03975790|141232257|SUPERIORITY|||||||0.9696|||||||t-test|||||||0.9696
70873315|NCT03975790|141232258|SUPERIORITY|||||||0.2514|||||||t-test|||||||0.2514
70873316|NCT03975790|141232258|SUPERIORITY|||||||0.9851|||||||t-test|||||||0.9851
70873317|NCT03975790|141232258|SUPERIORITY|||||||0.4309|||||||t-test|||||||0.4309
70873318|NCT03975790|141232259|SUPERIORITY|||||||0.6033|||||||t-test|||||||0.6033
70873319|NCT03975790|141232259|SUPERIORITY|||||||0.348|||||||t-test|||||||0.3480
70873320|NCT03975790|141232259|SUPERIORITY|||||||0.5375|||||||t-test|||||||0.5375
70873321|NCT03975790|141232260|SUPERIORITY|||||||0.0345|||||||Chi-squared|||Other aftercare||||0.0345
70873322|NCT03975790|141232260|SUPERIORITY|||||||0.2316|||||||Chi-squared|||Other aftercare||||0.2316
70873323|NCT03975790|141232260|SUPERIORITY|||||||0.7349|||||||Chi-squared|||Other aftercare||||0.7349
70873324|NCT03975790|141232260|SUPERIORITY|||||||0.0774|||||||Chi-squared|||Other connective tissue disease||||0.0774
70873325|NCT03975790|141232260|SUPERIORITY|||||||0.4228|||||||Chi-squared|||Other connective tissue disease||||0.4228
70873326|NCT03975790|141232260|SUPERIORITY|||||||0.0583|||||||Chi-squared|||Other connective tissue disease||||0.0583
70873327|NCT03975790|141232260|SUPERIORITY|||||||0.9683|||||||Chi-squared|||Other non-traumatic joint disorders||||0.9683
70873328|NCT03975790|141232260|SUPERIORITY|||||||0.8877|||||||Chi-squared|||Other non-traumatic joint disorders||||0.8877
70873329|NCT03975790|141232260|SUPERIORITY|||||||0.9228|||||||Chi-squared|||Other non-traumatic joint disorders||||0.9228
70873330|NCT03975790|141232260|SUPERIORITY|||||||0.7661|||||||Chi-squared|||Medical examination/evaluation||||0.7661
70873331|NCT03975790|141232260|SUPERIORITY|||||||0.3034|||||||Chi-squared|||Medical examination/evaluation||||0.3034
70873332|NCT03975790|141232260|SUPERIORITY|||||||0.2765|||||||Chi-squared|||Medical examination/evaluation||||0.2765
70873333|NCT03975790|141232260|SUPERIORITY|||||||0.8652|||||||Chi-squared|||Other suspected conditions||||0.8652
70873334|NCT03975790|141232260|SUPERIORITY|||||||0.2243|||||||Chi-squared|||Other suspected conditions||||0.2243
70873335|NCT03975790|141232260|SUPERIORITY|||||||0.3449|||||||Chi-squared|||Other suspected conditions||||0.3449
70873336|NCT03975790|141232260|SUPERIORITY|||||||0.3529|||||||Chi-squared|||Immunizations/screening for infectious disease||||0.3529
70873337|NCT03975790|141232260|SUPERIORITY|||||||0.1012|||||||Chi-squared|||Immunizations/screening for infectious disease||||0.1012
70873338|NCT03975790|141232260|SUPERIORITY|||||||0.4123|||||||Chi-squared|||Immunizations/screening for infectious disease||||0.4123
70873339|NCT03975790|141232260|SUPERIORITY|||||||0.2742|||||||Chi-squared|||Osteoarthritis||||0.2742
70873340|NCT03975790|141232260|SUPERIORITY|||||||0.1009|||||||Chi-squared|||Osteoarthritis||||0.1009
70873341|NCT03975790|141232260|SUPERIORITY|||||||0.0318|||||||Chi-squared|||Osteoarthritis||||0.0318
70873342|NCT03975790|141232260|SUPERIORITY|||||||0.4808|||||||Chi-squared|||Essential hypertension||||0.4808
70873343|NCT03975790|141232260|SUPERIORITY|||||||0.0778|||||||Chi-squared|||Essential hypertension||||0.0778
70873344|NCT03975790|141232260|SUPERIORITY|||||||0.2871|||||||Chi-squared|||Essential hypertension||||0.2871
70873345|NCT03975790|141232260|SUPERIORITY|||||||0.7356|||||||Chi-squared|||Residual codes; unclassified||||0.7356
70873346|NCT03975790|141232260|SUPERIORITY|||||||0.4975|||||||Chi-squared|||Residual codes; unclassified||||0.4975
70873347|NCT03975790|141232260|SUPERIORITY|||||||0.7143|||||||Chi-squared|||Residual codes; unclassified||||0.7143
70873348|NCT03975790|141232260|SUPERIORITY|||||||0.3559|||||||Chi-squared|||Disorders of lipid metabolism||||0.3559
70873349|NCT03975790|141232260|SUPERIORITY|||||||0.7725|||||||Chi-squared|||Disorders of lipid metabolism||||0.7725
70873350|NCT03975790|141232260|SUPERIORITY|||||||0.3875|||||||Chi-squared|||Disorders of lipid metabolism||||0.3875
70873351|NCT03975790|141232260|SUPERIORITY|||||||0.0225|||||||Chi-squared|||Back problems||||0.0225
70873352|NCT03975790|141232260|SUPERIORITY|||||||0.4427|||||||Chi-squared|||Back problems||||0.4427
70873353|NCT03975790|141232260|SUPERIORITY|||||||0.4094|||||||Chi-squared|||Back problems||||0.4094
70873354|NCT03975790|141232260|SUPERIORITY|||||||0.8775|||||||Chi-squared|||Other upper respiratory infections||||0.8775
70873355|NCT03975790|141232260|SUPERIORITY|||||||0.3525|||||||Chi-squared|||Other upper respiratory infections||||0.3525
70873356|NCT03975790|141232260|SUPERIORITY|||||||0.4724|||||||Chi-squared|||Other upper respiratory infections||||0.4724
70873357|NCT03975790|141232260|SUPERIORITY|||||||0.717|||||||Chi-squared|||Other lower respiratory disease||||0.7170
70873358|NCT03975790|141232260|SUPERIORITY|||||||0.2909|||||||Chi-squared|||Other lower respiratory disease||||0.2909
70873359|NCT03975790|141232260|SUPERIORITY|||||||0.5057|||||||Chi-squared|||Other lower respiratory disease||||0.5057
70873360|NCT03975790|141232260|SUPERIORITY|||||||0.2613|||||||Chi-squared|||Other nervous system disorders||||0.2613
71146039|NCT00385671|141785558|SUPERIORITY_OR_OTHER|||||||0.919||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in time to first ≥ 30% reduction in weekly mean 24 hour average pain score.||||0.919
70873361|NCT03975790|141232260|SUPERIORITY|||||||0.9901|||||||Chi-squared|||Other nervous system disorders||||0.9901
70873362|NCT03975790|141232260|SUPERIORITY|||||||0.4768|||||||Chi-squared|||Other nervous system disorders||||0.4768
70873363|NCT03975790|141232260|SUPERIORITY|||||||0.0219|||||||Chi-squared|||Other skin disorders||||0.0219
70873364|NCT03975790|141232260|SUPERIORITY|||||||0.5172|||||||Chi-squared|||Other skin disorders||||0.5172
70873365|NCT03975790|141232260|SUPERIORITY|||||||0.0278|||||||Chi-squared|||Other skin disorders||||0.0278
70873366|NCT03975790|141232260|SUPERIORITY|||||||0.6103|||||||Chi-squared|||Thyroid disorders||||0.6103
70873367|NCT03975790|141232260|SUPERIORITY|||||||0.1682|||||||Chi-squared|||Thyroid disorders||||0.1682
70873368|NCT03975790|141232260|SUPERIORITY|||||||0.3654|||||||Chi-squared|||Thyroid disorders||||0.3654
70873369|NCT03975790|141232260|SUPERIORITY|||||||0.7637|||||||Chi-squared|||Other bone disease/musculoskeletal deformities||||0.7637
70873370|NCT03975790|141232260|SUPERIORITY|||||||0.8693|||||||Chi-squared|||Other bone disease/musculoskeletal deformities||||0.8693
70873371|NCT03975790|141232260|SUPERIORITY|||||||0.7349|||||||Chi-squared|||Other bone disease/musculoskeletal deformities||||0.7349
70873372|NCT03975790|141232260|SUPERIORITY|||||||0.7324|||||||Chi-squared|||Malaise/fatigue||||0.7324
70873373|NCT03975790|141232260|SUPERIORITY|||||||0.4182|||||||Chi-squared|||Malaise/fatigue||||0.4182
70873374|NCT03975790|141232260|SUPERIORITY|||||||0.62|||||||Chi-squared|||Malaise/fatigue||||0.6200
70873375|NCT03975790|141232260|SUPERIORITY|||||||0.6064|||||||Chi-squared|||Esophageal disorders||||0.6064
70873376|NCT03975790|141232260|SUPERIORITY|||||||0.636|||||||Chi-squared|||Esophageal disorders||||0.6360
70873377|NCT03975790|141232260|SUPERIORITY|||||||0.9445|||||||Chi-squared|||Esophageal disorders||||0.9445
70873378|NCT03975790|141232260|SUPERIORITY|||||||0.8135|||||||Chi-squared|||Nutritional deficiencies||||0.8135
70873379|NCT03975790|141232260|SUPERIORITY|||||||0.6705|||||||Chi-squared|||Nutritional deficiencies||||0.6705
70873380|NCT03975790|141232260|SUPERIORITY|||||||0.8331|||||||Chi-squared|||Nutritional deficiencies||||0.8331
70873381|NCT03975790|141232260|SUPERIORITY|||||||0.4158|||||||Chi-squared|||Other nutritional; endocrine; and metabolic disorders||||0.4158
70873382|NCT03975790|141232260|SUPERIORITY|||||||0.636|||||||Chi-squared|||Other nutritional; endocrine; and metabolic disorders||||0.6360
70873383|NCT03975790|141232260|SUPERIORITY|||||||0.3336|||||||Chi-squared|||Other nutritional; endocrine; and metabolic disorders||||0.3336
70873384|NCT03975790|141232260|SUPERIORITY|||||||0.6402|||||||Chi-squared|||Diabetes mellitus without complication||||0.6402
70873385|NCT03975790|141232260|SUPERIORITY|||||||0.8068|||||||Chi-squared|||Diabetes mellitus without complication||||0.8068
70873386|NCT03975790|141232260|SUPERIORITY|||||||0.5983|||||||Chi-squared|||Diabetes mellitus without complication||||0.5983
70873387|NCT03975790|141232260|SUPERIORITY|||||||0.9759|||||||Chi-squared|||Other/unspecified benign neoplasm||||0.9759
70873388|NCT03975790|141232260|SUPERIORITY|||||||0.136|||||||Chi-squared|||Other/unspecified benign neoplasm||||0.1360
70873389|NCT03975790|141232260|SUPERIORITY|||||||0.1815|||||||Chi-squared|||Other/unspecified benign neoplasm||||0.1815
70873390|NCT03975790|141232260|SUPERIORITY|||||||0.2731|||||||Chi-squared|||Genitourinary symptoms/ill-defined conditions||||0.2731
70873391|NCT03975790|141232260|SUPERIORITY|||||||0.8327|||||||Chi-squared|||Genitourinary symptoms/ill-defined conditions||||0.8327
70873392|NCT03975790|141232260|SUPERIORITY|||||||0.342|||||||Chi-squared|||Genitourinary symptoms/ill-defined conditions||||0.3420
70873393|NCT03975790|141232261|SUPERIORITY|||||||0.059|||||||Chi-squared|||Rheumatoid arthritis/related disease||||0.0590
70873394|NCT03975790|141232261|SUPERIORITY|||||||0.7055|||||||Chi-squared|||Rheumatoid arthritis/related disease||||0.7055
70873395|NCT03975790|141232261|SUPERIORITY|||||||0.3088|||||||Chi-squared|||Rheumatoid arthritis/related disease||||0.3088
70873396|NCT03975790|141232261|SUPERIORITY|||||||0.0036|||||||Chi-squared|||Other aftercare||||0.0036
70873397|NCT03975790|141232261|SUPERIORITY|||||||0.3772|||||||Chi-squared|||Other aftercare||||0.3772
70873398|NCT03975790|141232261|SUPERIORITY|||||||0.3|||||||Chi-squared|||Other aftercare||||0.3000
70873399|NCT03975790|141232261|SUPERIORITY|||||||0.7354|||||||Chi-squared|||Other connective tissue disease||||0.7354
70873400|NCT03975790|141232261|SUPERIORITY|||||||0.1435|||||||Chi-squared|||Other connective tissue disease||||0.1435
70873401|NCT03975790|141232261|SUPERIORITY|||||||0.2876|||||||Chi-squared|||Other connective tissue disease||||0.2876
70873402|NCT03975790|141232261|SUPERIORITY|||||||0.2848|||||||Chi-squared|||Other non-traumatic joint disorders||||0.2848
70873403|NCT03975790|141232261|SUPERIORITY|||||||0.183|||||||Chi-squared|||Other non-traumatic joint disorders||||0.1830
70873404|NCT03975790|141232261|SUPERIORITY|||||||0.6453|||||||Chi-squared|||Other non-traumatic joint disorders||||0.6453
70873405|NCT03975790|141232261|SUPERIORITY|||||||0.8717|||||||Chi-squared|||Medical examination/evaluation||||0.8717
70873406|NCT03975790|141232261|SUPERIORITY|||||||0.8717|||||||Chi-squared|||Medical examination/evaluation||||0.8717
70873407|NCT03975790|141232261|SUPERIORITY|||||||0.3422|||||||Chi-squared|||Medical examination/evaluation||||0.3422
70873408|NCT03975790|141232261|SUPERIORITY|||||||0.3465|||||||Chi-squared|||Other suspected conditions||||0.3465
70873409|NCT03975790|141232261|SUPERIORITY|||||||0.4953|||||||Chi-squared|||Other suspected conditions||||0.4953
70873410|NCT03975790|141232261|SUPERIORITY|||||||0.9796|||||||Chi-squared|||Other suspected conditions||||0.9796
70873411|NCT03975790|141232261|SUPERIORITY|||||||0.4187|||||||Chi-squared|||Immunizations/screening for infectious disease||||0.4187
70873412|NCT03975790|141232261|SUPERIORITY|||||||0.151|||||||Chi-squared|||Immunizations/screening for infectious disease||||0.1510
70873413|NCT03975790|141232261|SUPERIORITY|||||||0.0751|||||||Chi-squared|||Immunizations/screening for infectious disease||||0.0751
70873414|NCT03975790|141232261|SUPERIORITY|||||||0.7577|||||||Chi-squared|||Osteoarthritis||||0.7577
70954684|NCT04348435|141412345|SUPERIORITY||Mean Difference (Net)|5.498|STANDARD_ERROR_OF_MEAN|6.073||0.3733|TWO_SIDED|95.0|||||ANCOVA|||Average General Health - Treatment Contrast||||0.3733
70954685|NCT04348435|141412345|SUPERIORITY||Mean Difference (Net)|2.433|STANDARD_ERROR_OF_MEAN|4.116||0.5594|TWO_SIDED|95.0|||||ANCOVA|||Average Physical Functioning - Treatment Contrast||||0.5594
70954686|NCT04348435|141412345|SUPERIORITY||Mean Difference (Net)|6.878|STANDARD_ERROR_OF_MEAN|5.389||0.2127|TWO_SIDED|95.0|||||ANCOVA|||Average Physical Functioning - Treatment Contrast||||0.2127
70954687|NCT04348435|141412345|SUPERIORITY||Mean Difference (Net)|3.67|STANDARD_ERROR_OF_MEAN|4.303||0.4012|TWO_SIDED|95.0|||||ANCOVA|||Average Physical Functioning - Treatment Contrast||||0.4012
70954688|NCT04348435|141412345|SUPERIORITY||Mean Difference (Net)|11.678|STANDARD_ERROR_OF_MEAN|5.748||0.0521|TWO_SIDED|95.0|||||ANCOVA|||Average Pain - Treatment Contrast||||0.0521
70954689|NCT04348435|141412345|SUPERIORITY||Mean Difference (Net)|5.635|STANDARD_ERROR_OF_MEAN|7.696||0.4704|TWO_SIDED|95.0|||||ANCOVA|||Average Pain - Treatment Contrast||||0.4704
70954690|NCT04348435|141412345|SUPERIORITY||Mean Difference (Net)|12.101|STANDARD_ERROR_OF_MEAN|6.017||0.0544|TWO_SIDED|95.0|||||ANCOVA|||Average Pain - Treatment Contrast||||0.0544
70873415|NCT03975790|141232261|SUPERIORITY|||||||0.802|||||||Chi-squared|||Osteoarthritis||||0.8020
70954691|NCT04348435|141412345|SUPERIORITY||Mean Difference (Net)|2.333|STANDARD_ERROR_OF_MEAN|3.888||0.5535|TWO_SIDED|95.0|||||ANCOVA|||Average Emotional Well Being - Treatment Contrast||||0.5535
70873416|NCT03975790|141232261|SUPERIORITY|||||||0.9879|||||||Chi-squared|||Osteoarthritis||||0.9879
70873417|NCT03975790|141232261|SUPERIORITY|||||||0.1717|||||||Chi-squared|||Essential hypertension||||0.1717
70873418|NCT03975790|141232261|SUPERIORITY|||||||0.3065|||||||Chi-squared|||Essential hypertension||||0.3065
70873419|NCT03975790|141232261|SUPERIORITY|||||||0.992|||||||Chi-squared|||Essential hypertension||||0.9920
70954692|NCT04348435|141412345|SUPERIORITY||Mean Difference (Net)|3.689|STANDARD_ERROR_OF_MEAN|4.969||0.4642|TWO_SIDED|95.0|||||ANCOVA|||Average Emotional Well Being - Treatment Contrast||||0.4642
70954693|NCT04348435|141412345|SUPERIORITY||Mean Difference (Net)|2.268|STANDARD_ERROR_OF_MEAN|3.936||0.5692|TWO_SIDED|95.0|||||ANCOVA|||Average Emotional Well Being - Treatment Contrast||||0.5692
70954694|NCT04348435|141412345|SUPERIORITY||Median Difference (Net)|2.667|STANDARD_ERROR_OF_MEAN|3.592||0.4642|TWO_SIDED|95.0|||||ANCOVA|||Avg. Role Limitations Due to Emotional Problems - Treatment Contrast||||0.4642
70954695|NCT04348435|141412345|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|4.444||1|TWO_SIDED|95.0|||||ANCOVA|||Avg. Role Limitations Due to Emotional Problems - Treatment Contrast||||1.0000
70954696|NCT04348435|141412345|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|3.526||1|TWO_SIDED|95.0|||||ANCOVA|||Avg. Role Limitations Due to Emotional Problems - Treatment Contrast||||1.0000
70954697|NCT04348435|141412346|SUPERIORITY||Mean Difference (Net)|-0.144|STANDARD_ERROR_OF_MEAN|0.825||0.8628|TWO_SIDED|95.0|||||ANCOVA|||||||0.8628
70954698|NCT04348435|141412346|SUPERIORITY||Mean Difference (Net)|-0.605|STANDARD_ERROR_OF_MEAN|0.94||0.5257|TWO_SIDED|95.0|||||ANCOVA|||||||0.5257
70954699|NCT04348435|141412346|SUPERIORITY||Mean Difference (Net)|-0.403|STANDARD_ERROR_OF_MEAN|0.659||0.5467|TWO_SIDED|95.0|||||ANCOVA|||||||0.5467
70873420|NCT03975790|141232261|SUPERIORITY|||||||0.4626|||||||Chi-squared|||Residual codes; unclassified||||0.4626
70873421|NCT03975790|141232261|SUPERIORITY|||||||0.8922|||||||Chi-squared|||Residual codes; unclassified||||0.8922
70873422|NCT03975790|141232261|SUPERIORITY|||||||0.7143|||||||Chi-squared|||Residual codes; unclassified||||0.7143
70873423|NCT03975790|141232261|SUPERIORITY|||||||0.8212|||||||Chi-squared|||Disorders of lipid metabolism||||0.8212
71146040|NCT00385671|141785561|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in time to first ≥ 2 points reduction in weekly mean 24 hour average pain score.||||0.008
70873424|NCT03975790|141232261|SUPERIORITY|||||||0.5732|||||||Chi-squared|||Disorders of lipid metabolism||||0.5732
70873425|NCT03975790|141232261|SUPERIORITY|||||||0.7319|||||||Chi-squared|||Disorders of lipid metabolism||||0.7319
70873426|NCT03975790|141232261|SUPERIORITY|||||||0.9272|||||||Chi-squared|||Back problems||||0.9272
70873427|NCT03975790|141232261|SUPERIORITY|||||||0.1441|||||||Chi-squared|||Back problems||||0.1441
70873428|NCT03975790|141232261|SUPERIORITY|||||||0.1859|||||||Chi-squared|||Back problems||||0.1859
70873429|NCT03975790|141232261|SUPERIORITY|||||||0.3109|||||||Chi-squared|||Other upper respiratory infections||||0.3109
70873430|NCT03975790|141232261|SUPERIORITY|||||||0.3313|||||||Chi-squared|||Other upper respiratory infections||||0.3313
70873431|NCT03975790|141232261|SUPERIORITY|||||||0.1279|||||||Chi-squared|||Other upper respiratory infections||||0.1279
70873432|NCT03975790|141232261|SUPERIORITY|||||||0.7575|||||||Chi-squared|||Other lower respiratory disease||||0.7575
70873433|NCT03975790|141232261|SUPERIORITY|||||||0.1583|||||||Chi-squared|||Other lower respiratory disease||||0.1583
70873434|NCT03975790|141232261|SUPERIORITY|||||||0.1569|||||||Chi-squared|||Other lower respiratory disease||||0.1569
70873435|NCT03975790|141232261|SUPERIORITY|||||||0.0745|||||||Chi-squared|||Other nervous system disorders||||0.0745
70873436|NCT03975790|141232261|SUPERIORITY|||||||0.0933|||||||Chi-squared|||Other nervous system disorders||||0.0933
70873437|NCT03975790|141232261|SUPERIORITY|||||||0.791|||||||Chi-squared|||Other nervous system disorders||||0.7910
70873438|NCT03975790|141232261|SUPERIORITY|||||||0.6755|||||||Chi-squared|||Other skin disorders||||0.6755
70873439|NCT03975790|141232261|SUPERIORITY|||||||0.4183|||||||Chi-squared|||Other skin disorders||||0.4183
70873440|NCT03975790|141232261|SUPERIORITY|||||||0.6749|||||||Chi-squared|||Other skin disorders||||0.6749
70873441|NCT03975790|141232261|SUPERIORITY|||||||0.6626|||||||Chi-squared|||Thyroid disorders||||0.6626
70873442|NCT03975790|141232261|SUPERIORITY|||||||0.5766|||||||Chi-squared|||Thyroid disorders||||0.5766
70873443|NCT03975790|141232261|SUPERIORITY|||||||0.8376|||||||Chi-squared|||Thyroid disorders||||0.8376
70873444|NCT03975790|141232261|SUPERIORITY|||||||0.2857|||||||Chi-squared|||Other bone disease/musculoskeletal deformities||||0.2857
70873445|NCT03975790|141232261|SUPERIORITY|||||||0.956|||||||Chi-squared|||Other bone disease/musculoskeletal deformities||||0.9560
70873446|NCT03975790|141232261|SUPERIORITY|||||||0.4384|||||||Chi-squared|||Other bone disease/musculoskeletal deformities||||0.4384
70873447|NCT03975790|141232261|SUPERIORITY|||||||0.6082|||||||Chi-squared|||Malaise/fatigue||||0.6082
70873448|NCT03975790|141232261|SUPERIORITY|||||||0.3374|||||||Chi-squared|||Malaise/fatigue||||0.3374
70873449|NCT03975790|141232261|SUPERIORITY|||||||0.5984|||||||Chi-squared|||Malaise/fatigue||||0.5984
70873450|NCT03975790|141232261|SUPERIORITY|||||||0.8568|||||||Chi-squared|||Esophageal disorders||||0.8568
70873451|NCT03975790|141232261|SUPERIORITY|||||||0.7698|||||||Chi-squared|||Esophageal disorders||||0.7698
70873452|NCT03975790|141232261|SUPERIORITY|||||||0.7089|||||||Chi-squared|||Esophageal disorders||||0.7089
70873453|NCT03975790|141232261|SUPERIORITY|||||||0.3446|||||||Chi-squared|||Nutritional deficiencies||||0.3446
70873454|NCT03975790|141232261|SUPERIORITY|||||||0.0815|||||||Chi-squared|||Nutritional deficiencies||||0.0815
70873455|NCT03975790|141232261|SUPERIORITY|||||||0.402|||||||Chi-squared|||Nutritional deficiencies||||0.4020
70873456|NCT03975790|141232261|SUPERIORITY|||||||0.4246|||||||Chi-squared|||Other nutritional: endocrine/metabolic disorders||||0.4246
70873457|NCT03975790|141232261|SUPERIORITY|||||||0.8118|||||||Chi-squared|||Other nutritional: endocrine/metabolic disorders||||0.8118
70873458|NCT03975790|141232261|SUPERIORITY|||||||0.7454|||||||Chi-squared|||Other nutritional: endocrine/metabolic disorders||||0.7454
70873459|NCT03975790|141232261|SUPERIORITY|||||||0.3559|||||||Chi-squared|||Diabetes mellitus without complication||||0.3559
70873460|NCT03975790|141232261|SUPERIORITY|||||||0.7698|||||||Chi-squared|||Diabetes mellitus without complication||||0.7698
70873461|NCT03975790|141232261|SUPERIORITY|||||||0.7323|||||||Chi-squared|||Diabetes mellitus without complication||||0.7323
70873462|NCT03975790|141232261|SUPERIORITY|||||||0.5935|||||||Chi-squared|||Other/unspecified benign neoplasm||||0.5935
70873463|NCT03975790|141232261|SUPERIORITY|||||||0.3928|||||||Chi-squared|||Other/unspecified benign neoplasm||||0.3928
70873464|NCT03975790|141232261|SUPERIORITY|||||||0.7089|||||||Chi-squared|||Other/unspecified benign neoplasm||||0.7089
70873465|NCT03975790|141232261|SUPERIORITY|||||||0.8746|||||||Chi-squared|||Other upper respiratory disease||||0.8746
70873466|NCT03975790|141232261|SUPERIORITY|||||||0.3835|||||||Chi-squared|||Other upper respiratory disease||||0.3835
71146041|NCT00385671|141785561|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in time to first ≥ 2 points reduction in weekly mean 24 hour average pain score.||||0.033
71146042|NCT00385671|141785561|SUPERIORITY_OR_OTHER|||||||0.688||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in time to first ≥ 2 points reduction in weekly mean 24 hour average pain score.||||0.688
70873467|NCT03975790|141232261|SUPERIORITY|||||||0.4992|||||||Chi-squared|||Other upper respiratory disease||||0.4992
70873468|NCT03975790|141232262|SUPERIORITY|||||||0.2336|||||||t-test|||||||0.2336
70873469|NCT03975790|141232262|SUPERIORITY|||||||0.2109|||||||t-test|||||||0.2109
70873470|NCT03975790|141232262|SUPERIORITY|||||||0.0691|||||||t-test|||||||0.0691
70873471|NCT03975790|141232263|SUPERIORITY|||||||0.9758|||||||Chi-squared|||MTX Sodium||||0.9758
70873472|NCT03975790|141232263|SUPERIORITY|||||||0.9978|||||||Chi-squared|||MTX Sodium||||0.9978
70873473|NCT03975790|141232263|SUPERIORITY|||||||0.9861|||||||Chi-squared|||MTX Sodium||||0.9861
70873474|NCT03975790|141232263|SUPERIORITY|||||||0.5744|||||||Chi-squared|||Folic Acid||||0.5744
70873475|NCT03975790|141232263|SUPERIORITY|||||||0.8542|||||||Chi-squared|||Folic Acid||||0.8542
70873476|NCT03975790|141232263|SUPERIORITY|||||||0.8363|||||||Chi-squared|||Folic Acid||||0.8363
70873477|NCT03975790|141232263|SUPERIORITY|||||||0.0473|||||||Chi-squared|||Prednisone||||0.0473
70873478|NCT03975790|141232263|SUPERIORITY|||||||0.0327|||||||Chi-squared|||Prednisone||||0.0327
70873479|NCT03975790|141232263|SUPERIORITY|||||||0.5348|||||||Chi-squared|||Prednisone||||0.5348
70873480|NCT03975790|141232263|SUPERIORITY|||||||0.6934|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate||||0.6934
70873481|NCT03975790|141232263|SUPERIORITY|||||||0.6017|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate||||0.6017
70873482|NCT03975790|141232263|SUPERIORITY|||||||0.4768|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate||||0.4768
70873483|NCT03975790|141232263|SUPERIORITY|||||||0.2315|||||||Chi-squared|||Azithromycin||||0.2315
70873484|NCT03975790|141232263|SUPERIORITY|||||||0.2588|||||||Chi-squared|||Azithromycin||||0.2588
70873485|NCT03975790|141232263|SUPERIORITY|||||||0.8576|||||||Chi-squared|||Azithromycin||||0.8576
70873486|NCT03975790|141232263|SUPERIORITY|||||||0.5909|||||||Chi-squared|||Adalimumab||||0.5909
70873487|NCT03975790|141232263|SUPERIORITY|||||||0.057|||||||Chi-squared|||Adalimumab||||0.0570
70873488|NCT03975790|141232263|SUPERIORITY|||||||0.0408|||||||Chi-squared|||Adalimumab||||0.0408
70873489|NCT03975790|141232263|SUPERIORITY|||||||0.6465|||||||Chi-squared|||Hydroxychloroquine Sulfate||||0.6465
70873490|NCT03975790|141232263|SUPERIORITY|||||||0.5654|||||||Chi-squared|||Hydroxychloroquine Sulfate||||0.5654
70873491|NCT03975790|141232263|SUPERIORITY|||||||0.8371|||||||Chi-squared|||Hydroxychloroquine Sulfate||||0.8371
70873492|NCT03975790|141232263|SUPERIORITY|||||||0.9654|||||||Chi-squared|||Etanercept||||0.9654
70873493|NCT03975790|141232263|SUPERIORITY|||||||0.1013|||||||Chi-squared|||Etanercept||||0.1013
70873494|NCT03975790|141232263|SUPERIORITY|||||||0.158|||||||Chi-squared|||Etanercept||||0.1580
70873495|NCT03975790|141232263|SUPERIORITY|||||||0.1663|||||||Chi-squared|||Levothyroxine Sodium||||0.1663
70873496|NCT03975790|141232263|SUPERIORITY|||||||0.6563|||||||Chi-squared|||Levothyroxine Sodium||||0.6563
70873497|NCT03975790|141232263|SUPERIORITY|||||||0.5785|||||||Chi-squared|||Levothyroxine Sodium||||0.5785
70873498|NCT03975790|141232263|SUPERIORITY|||||||0.4166|||||||Chi-squared|||Methylprednisolone||||0.4166
70873499|NCT03975790|141232263|SUPERIORITY|||||||0.0636|||||||Chi-squared|||Methylprednisolone||||0.0636
70873500|NCT03975790|141232263|SUPERIORITY|||||||0.3137|||||||Chi-squared|||Methylprednisolone||||0.3137
70873501|NCT03975790|141232263|SUPERIORITY|||||||0.4568|||||||Chi-squared|||Omeprazole||||0.4568
70873502|NCT03975790|141232263|SUPERIORITY|||||||0.5785|||||||Chi-squared|||Omeprazole||||0.5785
70873503|NCT03975790|141232263|SUPERIORITY|||||||0.9541|||||||Chi-squared|||Omeprazole||||0.9541
70873504|NCT03975790|141232263|SUPERIORITY|||||||0.1956|||||||Chi-squared|||Tramadol Hydrochloride||||0.1956
70873505|NCT03975790|141232263|SUPERIORITY|||||||0.3633|||||||Chi-squared|||Tramadol Hydrochloride||||0.3633
70873506|NCT03975790|141232263|SUPERIORITY|||||||0.9481|||||||Chi-squared|||Tramadol Hydrochloride||||0.9481
70873507|NCT03975790|141232263|SUPERIORITY|||||||0.3653|||||||Chi-squared|||Meloxicam||||0.3653
70873508|NCT03975790|141232263|SUPERIORITY|||||||0.9255|||||||Chi-squared|||Meloxicam||||0.9255
70873509|NCT03975790|141232263|SUPERIORITY|||||||0.5137|||||||Chi-squared|||Meloxicam||||0.5137
70873510|NCT03975790|141232263|SUPERIORITY|||||||0.6338|||||||Chi-squared|||Amoxicillin||||0.6338
70873511|NCT03975790|141232263|SUPERIORITY|||||||0.6329|||||||Chi-squared|||Amoxicillin||||0.6329
70873512|NCT03975790|141232263|SUPERIORITY|||||||0.9228|||||||Chi-squared|||Amoxicillin||||0.9228
70873513|NCT03975790|141232263|SUPERIORITY|||||||0.8433|||||||Chi-squared|||Albuterol Sulfate||||0.8433
70873514|NCT03975790|141232263|SUPERIORITY|||||||0.1175|||||||Chi-squared|||Albuterol Sulfate||||0.1175
70873515|NCT03975790|141232263|SUPERIORITY|||||||0.1215|||||||Chi-squared|||Albuterol Sulfate||||0.1215
70873516|NCT03975790|141232263|SUPERIORITY|||||||0.9007|||||||Chi-squared|||Gabapentin||||0.9007
70873517|NCT03975790|141232263|SUPERIORITY|||||||0.8789|||||||Chi-squared|||Gabapentin||||0.8789
70873518|NCT03975790|141232263|SUPERIORITY|||||||0.8305|||||||Chi-squared|||Gabapentin||||0.8305
70873519|NCT03975790|141232263|SUPERIORITY|||||||0.0694|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride||||0.0694
70873520|NCT03975790|141232263|SUPERIORITY|||||||0.8606|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride||||0.8606
70873521|NCT03975790|141232263|SUPERIORITY|||||||0.3363|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride||||0.3363
70873522|NCT03975790|141232263|SUPERIORITY|||||||0.3319|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium||||0.3319
70873523|NCT03975790|141232263|SUPERIORITY|||||||0.5615|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium||||0.5615
70873524|NCT03975790|141232263|SUPERIORITY|||||||0.8898|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium||||0.8898
70873525|NCT03975790|141232263|SUPERIORITY|||||||0.367|||||||Chi-squared|||Cyclobenzaprine Hydrochloride||||0.3670
70873526|NCT03975790|141232263|SUPERIORITY|||||||0.8155|||||||Chi-squared|||Cyclobenzaprine Hydrochloride||||0.8155
70873527|NCT03975790|141232263|SUPERIORITY|||||||0.7091|||||||Chi-squared|||Cyclobenzaprine Hydrochloride||||0.7091
70873528|NCT03975790|141232263|SUPERIORITY|||||||0.9769|||||||Chi-squared|||Fluticasone Propionate||||0.9769
70873529|NCT03975790|141232263|SUPERIORITY|||||||0.5032|||||||Chi-squared|||Fluticasone Propionate||||0.5032
70873530|NCT03975790|141232263|SUPERIORITY|||||||0.5631|||||||Chi-squared|||Fluticasone Propionate||||0.5631
70873531|NCT03975790|141232263|SUPERIORITY|||||||0.4426|||||||Chi-squared|||Ciprofloxacin Hydrochloride||||0.4426
70873532|NCT03975790|141232263|SUPERIORITY|||||||0.5734|||||||Chi-squared|||Ciprofloxacin Hydrochloride||||0.5734
70873533|NCT03975790|141232263|SUPERIORITY|||||||0.3071|||||||Chi-squared|||Ciprofloxacin Hydrochloride||||0.3071
70873534|NCT03975790|141232263|SUPERIORITY|||||||0.1608|||||||Chi-squared|||Duloxetine Hydrochloride||||0.1608
70873535|NCT03975790|141232263|SUPERIORITY|||||||0.4092|||||||Chi-squared|||Duloxetine Hydrochloride||||0.4092
70873536|NCT03975790|141232263|SUPERIORITY|||||||0.1215|||||||Chi-squared|||Duloxetine Hydrochloride||||0.1215
70873537|NCT03975790|141232263|SUPERIORITY|||||||0.7279|||||||Chi-squared|||Atorvastatin Calcium||||0.7279
70873538|NCT03975790|141232263|SUPERIORITY|||||||0.7703|||||||Chi-squared|||Atorvastatin Calcium||||0.7703
70873539|NCT03975790|141232263|SUPERIORITY|||||||0.6254|||||||Chi-squared|||Atorvastatin Calcium||||0.6254
70954789|NCT01982448|141412512|SUPERIORITY||Odds Ratio (OR)|2.22|||||TWO_SIDED|95.0|0.39|23.68|||||Association between HRD status and pathologic response was measured by the odds ratio (OR).|In the Cisplatin treated patients, the relationship between HRD status and pathologic response was conducted by arm using a univariate logistic regression model and a likelihood ratio test with a one-sided type I error of alpha 0.05. Assuming 12.5% unevaluable, prevalence of HR deficiency 60%, 70 evaluable patients per in a given arm, there is \~80% power to detect a response rate of 52% in HR-deficient patients vs a 16% in HR non-deficient patients, corresponding to the Odds Ratio 5.7.||23.68|0.39|
70954790|NCT01982448|141412512|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.19|4.95||||||In the Paclitaxel treated patients, the relationship between HRD status and pathologic response was conducted by arm using a univariate logistic regression model and a likelihood ratio test with a one-sided type I error of alpha 0.05. Assuming 12.5% unevaluable, prevalence of HR deficiency 60%, 70 evaluable patients per in a given arm, there is \~80% power to detect a response rate of 37% in HR-deficient patients vs a 16% in HR non-deficient patients, corresponding to the Odds Ratio 0.62.||4.95|0.19|
70954791|NCT01982448|141412513|SUPERIORITY||Odds Ratio (OR)|2.32|||||TWO_SIDED|95.0|0.23|118.07||||||||118.07|0.23|
70954792|NCT01982448|141412513|SUPERIORITY||Odds Ratio (OR)|0.55|||||TWO_SIDED|95.0|0.09|4.14||||||||4.14|0.09|
71146043|NCT00385671|141785563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.365|TWO_SIDED|95.0|-0.33|0.9||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week with participant is as a random effect, Kenward-Roger approximation.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean change from baseline to 12 weeks in 24 hour average pain severity score when analyzing only treatment-compliant participants.||0.90|-0.33|0.365
71146044|NCT00385671|141785563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46||||0.172|TWO_SIDED|95.0|-0.2|1.13||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week with participant is as a random effect, Kenward-Roger approximation.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Weekly mean change from baseline to 12 weeks in 24 hour average pain severity score when analyzing only treatment-compliant participants.||1.13|-0.20|0.172
71146045|NCT00385671|141785563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.594|TWO_SIDED|95.0|-0.49|0.85||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week with participant is as a random effect, Kenward-Roger approximation.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean change from baseline to 12 weeks in 24 hour average pain severity score when analyzing only treatment-compliant participants.||0.85|-0.49|0.594
70873540|NCT03975790|141232263|SUPERIORITY|||||||0.1615|||||||Chi-squared|||Diclofenac Sodium||||0.1615
70873541|NCT03975790|141232263|SUPERIORITY|||||||0.505|||||||Chi-squared|||Diclofenac Sodium||||0.5050
70873542|NCT03975790|141232263|SUPERIORITY|||||||0.1592|||||||Chi-squared|||Diclofenac Sodium||||0.1592
70873543|NCT03975790|141232263|SUPERIORITY|||||||0.6088|||||||Chi-squared|||Levofloxacin||||0.6088
71146046|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.622|TWO_SIDED|95.0|-0.48|0.8||P-value is for de novo, week 1. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.||0.80|-0.48|0.622
71146047|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49||||0.153|TWO_SIDED|95.0|-0.18|1.16||P-value is for de novo, week 1. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.||1.16|-0.18|0.153
70873544|NCT03975790|141232263|SUPERIORITY|||||||0.4713|||||||Chi-squared|||Levofloxacin||||0.4713
70873545|NCT03975790|141232263|SUPERIORITY|||||||0.3399|||||||Chi-squared|||Levofloxacin||||0.3399
70873546|NCT03975790|141232264|SUPERIORITY|||||||0.2349|||||||Chi-squared|||MTX Sodium||||0.2349
70873547|NCT03975790|141232264|SUPERIORITY|||||||0.3956|||||||Chi-squared|||MTX Sodium||||0.3956
70873548|NCT03975790|141232264|SUPERIORITY|||||||0.55|||||||Chi-squared|||Folic Acid||||0.5500
70954793|NCT02898077|141412519|SUPERIORITY||Hazard Ratio (HR)|0.765||||0.0184|TWO_SIDED|95.0|0.613|0.955|||Log Rank|||||0.955|0.613|0.0184
70954794|NCT02898077|141412520|SUPERIORITY||Hazard Ratio (HR)|0.963|||||TWO_SIDED|95.0|0.771|1.203||||||||1.203|0.771|
70954795|NCT02898077|141412521|SUPERIORITY||Hazard Ratio (HR)|0.761|||||TWO_SIDED|95.0|0.598|0.968||||||||0.968|0.598|
70954796|NCT02898077|141412522|SUPERIORITY||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.5|1.2||||||||1.2|0.5|
70954797|NCT02898077|141412523|SUPERIORITY||Hazard Ratio (HR)|0.905|||||TWO_SIDED|95.0|0.577|1.421||||||||1.421|0.577|
70954798|NCT04410523|141412531|SUPERIORITY||Least Squares mean|0.122|STANDARD_ERROR_OF_MEAN|0.0541||0.025|TWO_SIDED|95.0|0.016|0.229|||MMRM||Treatment difference (CSJ117-placebo)|||0.229|0.016|0.025
70873549|NCT03975790|141232264|SUPERIORITY|||||||0.7131|||||||Chi-squared|||Folic Acid||||0.7131
70873550|NCT03975790|141232264|SUPERIORITY|||||||0.942|||||||Chi-squared|||Folic Acid||||0.9420
70873551|NCT03975790|141232264|SUPERIORITY|||||||0.0571|||||||Chi-squared|||Prednisone||||0.0571
70873552|NCT03975790|141232264|SUPERIORITY|||||||0.049|||||||Chi-squared|||Prednisone||||0.0490
70873553|NCT03975790|141232264|SUPERIORITY|||||||0.5631|||||||Chi-squared|||Prednisone||||0.5631
70873554|NCT03975790|141232264|SUPERIORITY|||||||0.2198|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate||||0.2198
70873555|NCT03975790|141232264|SUPERIORITY|||||||0.385|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate||||0.3850
70873556|NCT03975790|141232264|SUPERIORITY|||||||0.1165|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate||||0.1165
70873557|NCT03975790|141232264|SUPERIORITY|||||||0.4291|||||||Chi-squared|||Azithromycin||||0.4291
70873558|NCT03975790|141232264|SUPERIORITY|||||||0.385|||||||Chi-squared|||Azithromycin||||0.3850
70873559|NCT03975790|141232264|SUPERIORITY|||||||0.8143|||||||Chi-squared|||Azithromycin||||0.8143
70873560|NCT03975790|141232264|SUPERIORITY|||||||0.7272|||||||Chi-squared|||Adalimumab||||0.7272
70873561|NCT03975790|141232264|SUPERIORITY|||||||0.0501|||||||Chi-squared|||Adalimumab||||0.0501
70954799|NCT04410523|141412531|SUPERIORITY||Least Squares mean|0.058|STANDARD_ERROR_OF_MEAN|0.0542||0.286|TWO_SIDED|95.0|-0.049|0.165|||MMRM||Treatment difference (CCSJ117-placebo)|||0.165|-0.049|0.286
70954800|NCT04410523|141412531|SUPERIORITY||Least Squares mean|0.065|STANDARD_ERROR_OF_MEAN|0.0521||0.212|TWO_SIDED|95.0|-0.037|0.168|||MMRM||Treatment difference (CCSJ117-placebo)|||0.168|-0.037|0.212
70954801|NCT04410523|141412531|SUPERIORITY||Least Squares mean|0.009|STANDARD_ERROR_OF_MEAN|0.043||0.831|TWO_SIDED|95.0|-0.076|0.094|||MMRM||Treatment difference (CCSJ117-placebo)|||0.094|-0.076|0.831
70954802|NCT04410523|141412531|SUPERIORITY||Least Squares mean|-0.008|STANDARD_ERROR_OF_MEAN|0.0434||0.852|TWO_SIDED|95.0|-0.094|0.077|||MMRM||Treatment difference (CCSJ117-placebo)|||0.077|-0.094|0.852
70954803|NCT04410523|141412532|SUPERIORITY||Least Squares mean|-1.568|STANDARD_ERROR_OF_MEAN|2.363||0.508|TWO_SIDED|95.0|-6.219|3.083|||MMRM||Treatment difference (CSJ117-placebo)|||3.083|-6.219|0.508
70954804|NCT04410523|141412532|SUPERIORITY||Least Squares mean|-3.998|STANDARD_ERROR_OF_MEAN|2.384||0.095|TWO_SIDED|95.0|-8.691|0.695|||MMRM||Treatment difference (CCSJ117-placebo)|||0.695|-8.691|0.095
70954805|NCT04410523|141412532|SUPERIORITY||Least Squares mean|-2.889|STANDARD_ERROR_OF_MEAN|2.2943||0.209|TWO_SIDED|95.0|-7.405|1.627|||MMRM||Treatment difference (CCSJ117-placebo)|||1.627|-7.405|0.209
70954806|NCT04410523|141412532|SUPERIORITY||Least Squares mean|-0.287|STANDARD_ERROR_OF_MEAN|1.8718||0.878|TWO_SIDED|95.0|-3.971|3.398|||MMRM||Treatment difference (CCSJ117-placebo)|||3.398|-3.971|0.878
70954807|NCT04410523|141412532|SUPERIORITY||Least Squares mean|1.093|STANDARD_ERROR_OF_MEAN|1.8652||0.558|TWO_SIDED|95.0|-2.578|4.765|||MMRM||Treatment difference (CCSJ117-placebo)|||4.765|-2.578|0.558
70954808|NCT04410523|141412535|SUPERIORITY||Least Squares mean|-0.042|STANDARD_ERROR_OF_MEAN|0.1493||0.78|TWO_SIDED|95.0|-0.336|0.252|||MMRM||Treatment difference (CSJ117-placebo)|||0.252|-0.336|0.780
70954809|NCT04410523|141412535|SUPERIORITY||Least Squares mean|-0.42|STANDARD_ERROR_OF_MEAN|0.1489||0.005|TWO_SIDED|95.0|-0.713|-0.127|||MMRM||Treatment difference (CCSJ117-placebo)|||-0.127|-0.713|0.005
70954810|NCT04410523|141412535|SUPERIORITY||Least Squares mean|-0.289|STANDARD_ERROR_OF_MEAN|0.1446||0.047|TWO_SIDED|95.0|-0.573|0.004|||MMRM||Treatment difference (CCSJ117-placebo)|||0.004|-0.573|0.047
70954811|NCT04410523|141412535|SUPERIORITY||Least Squares mean|-0.017|STANDARD_ERROR_OF_MEAN|0.1182||0.887|TWO_SIDED|95.0|-0.249|0.216|||MMRM||Treatment difference (CCSJ117-placebo)|||0.216|-0.249|0.887
70954812|NCT04410523|141412535|SUPERIORITY||Least Squares mean|-0.115|STANDARD_ERROR_OF_MEAN|0.1184||0.333|TWO_SIDED|95.0|-0.348|0.118|||MMRM||Treatment difference (CCSJ117-placebo)|||0.118|-0.348|0.333
70954813|NCT04410523|141412536|SUPERIORITY||Least Squares mean|-0.097|STANDARD_ERROR_OF_MEAN|0.1485||0.515|TWO_SIDED|95.0|-0.389|0.195|||MMRM||Treatment difference (CSJ117-placebo)|||0.195|-0.389|0.515
70954814|NCT04410523|141412536|SUPERIORITY||Least Squares mean|0.218|STANDARD_ERROR_OF_MEAN|0.1484||0.143|TWO_SIDED|95.0|-0.074|0.51|||MMRM||Treatment difference (CCSJ117-placebo)|||0.510|-0.074|0.143
70873562|NCT03975790|141232264|SUPERIORITY|||||||0.05|||||||Chi-squared|||Adalimumab||||0.0500
70873563|NCT03975790|141232264|SUPERIORITY|||||||0.3116|||||||Chi-squared|||Hydroxychloroquine Sulfate||||0.3116
70873564|NCT03975790|141232264|SUPERIORITY|||||||0.4882|||||||Chi-squared|||Hydroxychloroquine Sulfate||||0.4882
70873565|NCT03975790|141232264|SUPERIORITY|||||||0.9505|||||||Chi-squared|||Hydroxychloroquine Sulfate||||0.9505
70873566|NCT03975790|141232264|SUPERIORITY|||||||0.408|||||||Chi-squared|||Etanercept||||0.4080
70873567|NCT03975790|141232264|SUPERIORITY|||||||0.7644|||||||Chi-squared|||Etanercept||||0.7644
70873568|NCT03975790|141232264|SUPERIORITY|||||||0.4146|||||||Chi-squared|||Etanercept||||0.4146
70873569|NCT03975790|141232264|SUPERIORITY|||||||0.1348|||||||Chi-squared|||Levothyroxine Sodium||||0.1348
70873570|NCT03975790|141232264|SUPERIORITY|||||||0.5948|||||||Chi-squared|||Levothyroxine Sodium||||0.5948
70873571|NCT03975790|141232264|SUPERIORITY|||||||0.5785|||||||Chi-squared|||Levothyroxine Sodium||||0.5785
70954815|NCT04410523|141412536|SUPERIORITY||Least Squares mean|0.078|STANDARD_ERROR_OF_MEAN|0.145||0.59|TWO_SIDED|95.0|-0.207|0.364|||MMRM||Treatment difference (CCSJ117-placebo)|||0.364|-0.207|0.590
71146048|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.344|TWO_SIDED|95.0|-0.35|1.0||P-value is for de novo, week 1. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.||1.00|-0.35|0.344
71146049|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71||||0.058|TWO_SIDED|95.0|-0.02|1.45||P-value is for de novo, week 2. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 2.||1.45|-0.02|0.058
71146050|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83||||0.032|TWO_SIDED|95.0|0.07|1.59||P-value is for de novo, week 2. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 2.||1.59|0.07|0.032
71146051|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.762|TWO_SIDED|95.0|-0.66|0.9||P-value is for de novo, week 2. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 2.||0.90|-0.66|0.762
71146052|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91||||0.029|TWO_SIDED|95.0|0.09|1.73||P-value is for de novo, week 3. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 3.||1.73|0.09|0.029
71146053|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12||||0.01|TWO_SIDED|95.0|0.27|1.97||P-value is for de nove, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 3.||1.97|0.27|0.010
71146054|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.619|TWO_SIDED|95.0|-0.63|1.06||P-value is for de nove, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 3.||1.06|-0.63|0.619
71146055|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83||||0.058|TWO_SIDED|95.0|-0.03|1.69||P-value is for de novo, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 4.||1.69|-0.03|0.058
71146056|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51||||0.001|TWO_SIDED|95.0|0.61|2.41||P-value is for de novo, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 4.||2.41|0.61|0.001
71146057|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68||||0.142|TWO_SIDED|95.0|-0.23|1.58||P-value is for de nove, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.||1.58|-0.23|0.142
71146058|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.065|TWO_SIDED|95.0|-0.05|1.76||P-value is for de novo, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 5.||1.76|-0.05|0.065
71146059|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|||<|0.001|TWO_SIDED|95.0|0.75|2.65||P-value is for de novo, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 5.||2.65|0.75|<0.001
71146060|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.079|TWO_SIDED|95.0|-0.1|1.79||P-value is for de novo, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 5.||1.79|-0.10|0.079
70873572|NCT03975790|141232264|SUPERIORITY|||||||0.1033|||||||Chi-squared|||Methylprednisolone||||0.1033
70873573|NCT03975790|141232264|SUPERIORITY|||||||0.2117|||||||Chi-squared|||Methylprednisolone||||0.2117
70873574|NCT03975790|141232264|SUPERIORITY|||||||0.992|||||||Chi-squared|||Methylprednisolone||||0.9920
70873575|NCT03975790|141232264|SUPERIORITY|||||||0.9212|||||||Chi-squared|||Omeprazole||||0.9212
70873576|NCT03975790|141232264|SUPERIORITY|||||||0.9212|||||||Chi-squared|||Omeprazole||||0.9212
70873577|NCT03975790|141232264|SUPERIORITY|||||||0.4384|||||||Chi-squared|||Omeprazole||||0.4384
70873578|NCT03975790|141232264|SUPERIORITY|||||||0.0162|||||||Chi-squared|||Tramadol Hydrochloride||||0.0162
71146061|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79||||0.093|TWO_SIDED|95.0|-0.13|1.71||P-value is for de novo, 6 week. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 6.||1.71|-0.13|0.093
71146062|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.56||||0.002|TWO_SIDED|95.0|0.59|2.53||P-value is for de novo, 6 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 6.||2.53|0.59|0.002
71146063|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77||||0.119|TWO_SIDED|95.0|-0.2|1.74||P-value is for de novo, 6 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 6.||1.74|-0.20|0.119
71146064|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.98||||0.036|TWO_SIDED|95.0|0.06|1.91||P-value is for de novo, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 7.||1.91|0.06|0.036
71146065|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.65|||<|0.001|TWO_SIDED|95.0|0.68|2.61||P-value is for de novo, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 7.||2.61|0.68|<0.001
71146066|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.178|TWO_SIDED|95.0|-0.3|1.63||P-value is for de novo, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 7.||1.63|-0.30|0.178
71146067|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81||||0.093|TWO_SIDED|95.0|-0.14|1.75||P-value is for de novo, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 8.||1.75|-0.14|0.093
71146068|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.52||||0.003|TWO_SIDED|95.0|0.53|2.51||P-value is for de novo, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 7.||2.51|0.53|0.003
70873579|NCT03975790|141232264|SUPERIORITY|||||||0.3239|||||||Chi-squared|||Tramadol Hydrochloride||||0.3239
70873580|NCT03975790|141232264|SUPERIORITY|||||||0.4837|||||||Chi-squared|||Tramadol Hydrochloride||||0.4837
71146069|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72||||0.157|TWO_SIDED|95.0|-0.28|1.71||P-value is for de novo, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.||1.71|-0.28|0.157
70954816|NCT04410523|141412536|SUPERIORITY||Least Squares mean|0.033|STANDARD_ERROR_OF_MEAN|0.118||0.778|TWO_SIDED|95.0|-0.199|0.265|||MMRM||Treatment difference (CCSJ117-placebo)|||0.265|-0.199|0.778
70954817|NCT04410523|141412536|SUPERIORITY||Least Squares mean|0.073|STANDARD_ERROR_OF_MEAN|0.118||0.539|TWO_SIDED|95.0|-0.16|0.305|||MMRM||Treatment difference (CCSJ117-placebo)|||0.305|-0.160|0.539
70954818|NCT00127205|141412588|OTHER|||||||0.49|||||||Log Rank|||||||0.49
71146070|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.063|TWO_SIDED|95.0|-0.05|1.82||P-value is for de novo, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 9.||1.82|-0.05|0.063
71146071|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68|||<|0.001|TWO_SIDED|95.0|0.7|2.66||P-value is for de novo, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 9.||2.66|0.70|<0.001
71146072|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79||||0.114|TWO_SIDED|95.0|-0.19|1.77||P-value is for de novo, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 9.||1.77|-0.19|0.114
71146073|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.51||||0.295|TWO_SIDED|95.0|-0.44|1.46||P-value is for de novo, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 10.||1.46|-0.44|0.295
71146074|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44||||0.005|TWO_SIDED|95.0|0.45|2.44||P-value is for de novo, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 10.||2.44|0.45|0.005
70873581|NCT03975790|141232264|SUPERIORITY|||||||0.7183|||||||Chi-squared|||Meloxicam||||0.7183
70873582|NCT03975790|141232264|SUPERIORITY|||||||0.2667|||||||Chi-squared|||Meloxicam||||0.2667
70873583|NCT03975790|141232264|SUPERIORITY|||||||0.451|||||||Chi-squared|||Meloxicam||||0.4510
70873584|NCT03975790|141232264|SUPERIORITY|||||||0.7993|||||||Chi-squared|||Amoxicillin||||0.7993
70873585|NCT03975790|141232264|SUPERIORITY|||||||0.9896|||||||Chi-squared|||Amoxicillin||||0.9896
70873586|NCT03975790|141232264|SUPERIORITY|||||||0.8576|||||||Chi-squared|||Amoxicillin||||0.8576
70954819|NCT00127205|141412588|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.24|TWO_SIDED|95.0|0.94|1.26|||Regression, Cox|||||1.26|0.94|0.24
70954820|NCT00127205|141412588|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.5|TWO_SIDED|95.0|0.9|1.24|||Regression, Cox|||||1.24|0.90|0.50
70954821|NCT00127205|141412589|OTHER|||||||0.5|||||||Log Rank|||||||0.50
70954822|NCT00127205|141412590|OTHER|||||||0.93|||||||Log Rank|||Statistical analysis for recurrence to bone||||0.93
70954823|NCT03582943|141412615|SUPERIORITY|A priori power analyses was designed to detect at least a 3 second difference in change in balance scores between groups.|Mean Difference (Net)|0.74||||0.984|TWO_SIDED|||||Test of differences between groups.|Mixed Models Analysis|||||||0.984
70873587|NCT03975790|141232264|SUPERIORITY|||||||0.9373|||||||Chi-squared|||Albuterol Sulfate||||0.9373
70873588|NCT03975790|141232264|SUPERIORITY|||||||0.1253|||||||Chi-squared|||Albuterol Sulfate||||0.1253
70873589|NCT03975790|141232264|SUPERIORITY|||||||0.1851|||||||Chi-squared|||Albuterol Sulfate||||0.1851
70873590|NCT03975790|141232264|SUPERIORITY|||||||0.8697|||||||Chi-squared|||Gabapentin||||0.8697
70873591|NCT03975790|141232264|SUPERIORITY|||||||0.9719|||||||Chi-squared|||Gabapentin||||0.9719
70873592|NCT03975790|141232264|SUPERIORITY|||||||0.938|||||||Chi-squared|||Gabapentin||||0.9380
70873593|NCT03975790|141232264|SUPERIORITY|||||||0.1079|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride||||0.1079
70954824|NCT03582943|141412615|SUPERIORITY||Mean Difference (Net)|-0.023||||0.455|TWO_SIDED|||||Test of interaction between age and RLIC vs. sham|Mixed Models Analysis|||||||.455
70954825|NCT03582943|141412615|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.803|TWO_SIDED|||||Test of interaction between sex and RLIC vs. sham conditioning|Mixed Models Analysis|||||||0.803
70954826|NCT03582943|141412615|SUPERIORITY||Mean Difference (Net)|0.25||||0.233|TWO_SIDED|||||Test of interaction between BMI and RLIC vs. sham conditioning|Mixed Models Analysis|||||||0.233
70954827|NCT03582943|141412615|SUPERIORITY|Test of interaction between presence of co-morbidities and RLIC vs. sham conditioning|Mean Difference (Net)|4.12||||0.29|TWO_SIDED||||||Mixed Models Analysis|||||||0.29
70954828|NCT05032872|141412616|SUPERIORITY|||||||0.49||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time by condition interaction||||.49
70873594|NCT03975790|141232264|SUPERIORITY|||||||0.2588|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride||||0.2588
70873595|NCT03975790|141232264|SUPERIORITY|||||||0.9358|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride||||0.9358
70954829|NCT05032872|141412617|SUPERIORITY|||||||0.48||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.48
70873596|NCT03975790|141232264|SUPERIORITY|||||||0.1984|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium||||0.1984
70873597|NCT03975790|141232264|SUPERIORITY|||||||0.8542|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium||||0.8542
70873598|NCT03975790|141232264|SUPERIORITY|||||||0.2973|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium||||0.2973
70873599|NCT03975790|141232264|SUPERIORITY|||||||0.1046|||||||Chi-squared|||Cyclobenzaprine Hydrochloride||||0.1046
70873600|NCT03975790|141232264|SUPERIORITY|||||||0.7961|||||||Chi-squared|||Cyclobenzaprine Hydrochloride||||0.7961
70873601|NCT03975790|141232264|SUPERIORITY|||||||0.214|||||||Chi-squared|||Cyclobenzaprine Hydrochloride||||0.2140
70873602|NCT03975790|141232264|SUPERIORITY|||||||0.8578|||||||Chi-squared|||Fluticasone Propionate||||0.8578
70873603|NCT03975790|141232264|SUPERIORITY|||||||0.7131|||||||Chi-squared|||Fluticasone Propionate||||0.7131
70873604|NCT03975790|141232264|SUPERIORITY|||||||0.8421|||||||Chi-squared|||Fluticasone Propionate||||0.8421
70873605|NCT03975790|141232264|SUPERIORITY|||||||0.7637|||||||Chi-squared|||Ciprofloxacin Hydrochloride||||0.7637
70873606|NCT03975790|141232264|SUPERIORITY|||||||0.6355|||||||Chi-squared|||Ciprofloxacin Hydrochloride||||0.6355
70873607|NCT03975790|141232264|SUPERIORITY|||||||0.5425|||||||Chi-squared|||Ciprofloxacin Hydrochloride||||0.5425
70873608|NCT03975790|141232264|SUPERIORITY|||||||0.041|||||||Chi-squared|||Duloxetine Hydrochloride||||0.0410
70873609|NCT03975790|141232264|SUPERIORITY|||||||0.8251|||||||Chi-squared|||Duloxetine Hydrochloride||||0.8251
70873610|NCT03975790|141232264|SUPERIORITY|||||||0.2871|||||||Chi-squared|||Duloxetine Hydrochloride||||0.2871
70873611|NCT03975790|141232264|SUPERIORITY|||||||0.1174|||||||Chi-squared|||Diclofenac Sodium||||0.1174
70873612|NCT03975790|141232264|SUPERIORITY|||||||0.9702|||||||Chi-squared|||Diclofenac Sodium||||0.9702
70873613|NCT03975790|141232264|SUPERIORITY|||||||0.3109|||||||Chi-squared|||Diclofenac Sodium||||0.3109
70873614|NCT03975790|141232264|SUPERIORITY|||||||0.6744|||||||Chi-squared|||Levofloxacin||||0.6744
70873615|NCT03975790|141232264|SUPERIORITY|||||||0.8121|||||||Chi-squared|||Levofloxacin||||0.8121
70873616|NCT03975790|141232264|SUPERIORITY|||||||0.9451|||||||Chi-squared|||Levofloxacin||||0.9451
70873617|NCT03975790|141232264|SUPERIORITY|||||||0.166|||||||Chi-squared|||Cephalexin||||0.1660
70873618|NCT03975790|141232264|SUPERIORITY|||||||0.9549|||||||Chi-squared|||Cephalexin||||0.9549
70873619|NCT03975790|141232264|SUPERIORITY|||||||0.3104|||||||Chi-squared|||Cephalexin||||0.3104
70873620|NCT03975790|141232264|SUPERIORITY|||||||0.0489|||||||Chi-squared|||Ibuprofen||||0.0489
70873621|NCT03975790|141232264|SUPERIORITY|||||||0.1515|||||||Chi-squared|||Ibuprofen||||0.1515
70873622|NCT03975790|141232264|SUPERIORITY|||||||0.9481|||||||Chi-squared|||Ibuprofen||||0.9481
70873623|NCT03975790|141232265|SUPERIORITY|||||||0.2178|||||||Chi-squared|||||||0.2178
70873624|NCT03975790|141232265|SUPERIORITY|||||||0.5237|||||||Chi-squared|||||||0.5237
70873625|NCT03975790|141232265|SUPERIORITY|||||||0.7964|||||||Chi-squared|||||||0.7964
70873626|NCT03975790|141232266|SUPERIORITY|||||||0.9085|||||||Chi-squared|||||||0.9085
70873627|NCT03975790|141232266|SUPERIORITY|||||||0.6283|||||||Chi-squared|||||||0.6283
70873628|NCT03975790|141232266|SUPERIORITY|||||||0.7293|||||||Chi-squared|||||||0.7293
70873629|NCT03975790|141232267|SUPERIORITY|||||||0.9392|||||||Chi-squared|||||||0.9392
70873630|NCT03975790|141232267|SUPERIORITY|||||||0.3063|||||||Chi-squared|||||||0.3063
70873631|NCT03975790|141232267|SUPERIORITY|||||||0.3467|||||||Chi-squared|||||||0.3467
70873632|NCT03975790|141232268|SUPERIORITY|||||||0.7977|||||||Chi-squared|||||||0.7977
70873633|NCT03975790|141232268|SUPERIORITY|||||||0.5241|||||||Chi-squared|||||||0.5241
70873634|NCT03975790|141232268|SUPERIORITY|||||||0.4702|||||||Chi-squared|||||||0.4702
70873635|NCT03975790|141232269|SUPERIORITY|||||||0.1461|||||||t-test|||||||0.1461
70873636|NCT03975790|141232269|SUPERIORITY|||||||0.1411|||||||t-test|||||||0.1411
70873637|NCT03975790|141232269|SUPERIORITY|||||||0.4201|||||||t-test|||||||0.4201
70873638|NCT03975790|141232270|SUPERIORITY|||||||0.3955|||||||t-test|||||||0.3955
70873639|NCT03975790|141232270|SUPERIORITY|||||||0.6356|||||||t-test|||||||0.6356
70873640|NCT03975790|141232270|SUPERIORITY|||||||0.3833|||||||t-test|||||||0.3833
70873641|NCT03975790|141232271|SUPERIORITY|||||||0.3292|||||||t-test|||||||0.3292
70873642|NCT03975790|141232271|SUPERIORITY|||||||0.2959|||||||t-test|||||||0.2959
70873643|NCT03975790|141232271|SUPERIORITY|||||||0.6962|||||||t-test|||||||0.6962
70873644|NCT03975790|141232272|SUPERIORITY|||||||0.8138|||||||t-test|||||||0.8138
70873645|NCT03975790|141232272|SUPERIORITY|||||||0.007|||||||t-test|||||||0.0070
70873646|NCT03975790|141232272|SUPERIORITY|||||||0.0358|||||||t-test|||||||0.0358
70873647|NCT03975790|141232273|SUPERIORITY|||||||0.8453|||||||t-test|||||||0.8453
70873648|NCT03975790|141232273|SUPERIORITY|||||||0.4806|||||||t-test|||||||0.4806
70873649|NCT03975790|141232273|SUPERIORITY|||||||0.4809|||||||t-test|||||||0.4809
70873650|NCT03975790|141232274|SUPERIORITY|||||||0.3076|||||||t-test|||||||0.3076
70873651|NCT03975790|141232274|SUPERIORITY|||||||0.2509|||||||t-test|||||||0.2509
70873652|NCT03975790|141232274|SUPERIORITY|||||||0.7827|||||||t-test|||||||0.7827
70873653|NCT03975790|141232275|SUPERIORITY|||||||0.4261|||||||Chi-squared|||During Persistency||||0.4261
70873654|NCT03975790|141232275|SUPERIORITY|||||||0.5247|||||||Chi-squared|||During Persistency||||0.5247
70954830|NCT05032872|141412618|SUPERIORITY|||||||0.04||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting satisfaction with contact quality||||.04
70954831|NCT05032872|141412618|SUPERIORITY|||||||0.44||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting dissatisfaction with contact quantity||||.44
70954832|NCT05032872|141412618|SUPERIORITY|||||||0.99||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting satisfaction with contact quantity||||.99
70954833|NCT05032872|141412618|SUPERIORITY|||||||0.87||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting knowing others' experience||||.87
70954834|NCT05032872|141412618|SUPERIORITY|||||||0.98||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting shared understanding||||.98
71146075|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94||||0.066|TWO_SIDED|95.0|-0.06|1.94||P-value is for de novo, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 10.||1.94|-0.06|0.066
71146076|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62||||0.208|TWO_SIDED|95.0|-0.35|1.58||P-value is for de novo, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 11.||1.58|-0.35|0.208
71146077|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.004|TWO_SIDED|95.0|0.49|2.51||P-value is for de novo, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 11.||2.51|0.49|0.004
71146078|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.88||||0.086|TWO_SIDED|95.0|-0.13|1.89||P-value is for de novo, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 11.||1.89|-0.13|0.086
71146079|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48||||0.328|TWO_SIDED|95.0|-0.49|1.45||P-value is for de novo, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 12.||1.45|-0.49|0.328
70954835|NCT05032872|141412618|SUPERIORITY|||||||0.76||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting relationship salience||||.76
70954836|NCT05032872|141412619|SUPERIORITY|||||||0.29||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.29
70954837|NCT05032872|141412620|SUPERIORITY|||||||0.51||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition predicting positive affect||||.51
70954838|NCT05032872|141412620|SUPERIORITY|||||||0.83||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition predicting negative affect||||.83
70954839|NCT05032872|141412621|SUPERIORITY|||||||0.51||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.51
70954840|NCT05032872|141412622|SUPERIORITY|||||||0.65||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.65
70954841|NCT05032872|141412623|SUPERIORITY|||||||0.01||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting management of distress||||.01
70954842|NCT05032872|141412623|SUPERIORITY|||||||0.75||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||time x condition interaction predicting caregiver overload||||.75
70954843|NCT05032872|141412623|SUPERIORITY|||||||0.59||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting relational deprivation||||.59
70954844|NCT05032872|141412623|SUPERIORITY|||||||0.51||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting job caregiving conflict||||.51
70873655|NCT03975790|141232275|SUPERIORITY|||||||0.2809|||||||Chi-squared|||During Persistency||||0.2809
70873656|NCT03975790|141232275|SUPERIORITY|||||||0.1153|||||||Chi-squared|||Post Persistency||||0.1153
71146080|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46||||0.005|TWO_SIDED|95.0|0.44|2.47||P-value is for de novo, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 12.||2.47|0.44|0.005
71146081|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.98||||0.059|TWO_SIDED|95.0|-0.04|1.99||P-value is for de novo, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 12.||1.99|-0.04|0.059
71146082|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.117|TWO_SIDED|95.0|-0.09|0.79||P-value is for prior use, 1 week. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 1.||0.79|-0.09|0.117
71146083|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.412|TWO_SIDED|95.0|-0.25|0.62||P-value is for prior use, 1 week. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 1.||0.62|-0.25|0.412
70873657|NCT03975790|141232275|SUPERIORITY|||||||0.1344|||||||Chi-squared|||Post Persistency||||0.1344
70873658|NCT03975790|141232275|SUPERIORITY|||||||0.8229|||||||Chi-squared|||Post Persistency||||0.8229
70873659|NCT03975790|141232276|SUPERIORITY|||||||0.7816|||||||Chi-squared|||During Persistency||||0.7816
70873660|NCT03975790|141232276|SUPERIORITY|||||||0.7124|||||||Chi-squared|||During Persistency||||0.7124
70873661|NCT03975790|141232276|SUPERIORITY|||||||0.6148|||||||Chi-squared|||During Persistency||||0.6148
70873662|NCT03975790|141232276|SUPERIORITY|||||||0.4876|||||||Chi-squared|||Post Persistency||||0.4876
70873663|NCT03975790|141232276|SUPERIORITY|||||||0.7826|||||||Chi-squared|||Post Persistency||||0.7826
70873664|NCT03975790|141232276|SUPERIORITY|||||||0.8337|||||||Chi-squared|||Post Persistency||||0.8337
70873665|NCT03975790|141232277|SUPERIORITY|||||||0.1344|||||||Chi-squared|||||||0.1344
70873666|NCT03975790|141232277|SUPERIORITY|||||||0.0095|||||||Chi-squared|||||||0.0095
70873667|NCT03975790|141232277|SUPERIORITY|||||||0.1406|||||||Chi-squared|||||||0.1406
70873668|NCT03975790|141232278|SUPERIORITY|||||||0.9379|||||||Chi-squared|||||||0.9379
70873669|NCT03975790|141232278|SUPERIORITY|||||||0.3025|||||||Chi-squared|||||||0.3025
70954845|NCT05032872|141412623|SUPERIORITY|||||||0.25||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting role captivity||||.25
70954846|NCT05032872|141412623|SUPERIORITY|||||||0.34||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting sense of self||||.34
70954847|NCT05032872|141412623|SUPERIORITY|||||||0.75||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting personal gain||||.75
70954848|NCT05032872|141412623|SUPERIORITY|||||||0.99||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting caregiving competence||||.99
70954849|NCT05032872|141412623|SUPERIORITY|||||||0.61||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting management of situition||||.61
70954850|NCT05032872|141412623|SUPERIORITY|||||||0.92||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting management of meaning||||.92
70954851|NCT05032872|141412623|SUPERIORITY|||||||0.96||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting expressive support||||.96
70954852|NCT05032872|141412624|SUPERIORITY|||||||0.37||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.37
70954853|NCT05032872|141412625|SUPERIORITY|||||||0.89||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.89
70954854|NCT05032872|141412626|SUPERIORITY|||||||0.3||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.30
70873670|NCT03975790|141232278|SUPERIORITY|||||||0.3388|||||||Chi-squared|||||||0.3388
70954855|NCT05032872|141412627|SUPERIORITY|||||||0.52||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.52
70954856|NCT05032872|141412628|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||Independent sample T-test comparing the treatment and control group||||.45
70954857|NCT02946853|141412668|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.14|7.21|||Regression, Logistic|||||7.21|0.14|1.00
70954858|NCT02946853|141412669|SUPERIORITY||Mean Difference (Net)|-1.0||||0.974|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.974
70954859|NCT02946853|141412670|SUPERIORITY||Mean Difference (Net)|0.5||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Some patients did not undergo 6 month echocardiogram due to restrictions related to COVID-19.||||1.00
70954860|NCT02946853|141412671|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.1|84.4|||Fisher Exact|||||84.4|0.1|1.00
70954861|NCT02946853|141412672|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED||||||Fisher Exact|||||||1.00
70954862|NCT02946853|141412673|SUPERIORITY||Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|0.0|42.0|||Fisher Exact|||||42.00|0.00|1.00
70954863|NCT02946853|141412674|SUPERIORITY||Mean Difference (Final Values)|20.6||||0.005|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.005
70954864|NCT02946853|141412675|SUPERIORITY||Median Difference (Final Values)|23.7||||0.565|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.565
70954865|NCT02946853|141412676|SUPERIORITY||Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|0.0|42.0|||Fisher Exact|||||42.0|0.0|1.00
70954866|NCT01404429|141412679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.6|TWO_SIDED|95.0|-0.26|0.54|||t-test, 2 sided|||||0.54|-0.26|0.6
70954867|NCT01163292|141412702|SUPERIORITY_OR_OTHER|||||||0.144||95.0|||||Wilcoxon Rank Sum|||Week 0||||0.144
70954868|NCT01163292|141412702|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Wilcoxon Rank Sum|||Week 26||||0.004
70954869|NCT01163292|141412702|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Wilcoxon Rank Sum|||Week 52||||0.006
70954870|NCT01163292|141412703|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Fisher Exact|||Week 0||||0.290
70954871|NCT01163292|141412703|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Week 26||||1.000
70954872|NCT01163292|141412703|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||Week 52||||0.001
70954873|NCT01163292|141412704|SUPERIORITY_OR_OTHER|||||||0.335||95.0|||||Wilcoxon Rank Sum|||||||0.335
70873671|NCT03975790|141232279|SUPERIORITY|||||||0.8205|||||||t-test|||||||0.8205
70873672|NCT03975790|141232279|SUPERIORITY|||||||0.0467|||||||t-test|||||||0.0467
70873673|NCT03975790|141232279|SUPERIORITY|||||||0.1083|||||||t-test|||||||0.1083
70873674|NCT03975790|141232280|SUPERIORITY|||||||0.8899|||||||t-test|||||||0.8899
70873675|NCT03975790|141232280|SUPERIORITY|||||||0.6183|||||||t-test|||||||0.6183
70954874|NCT01163292|141412705|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||Wilcoxon Rank Sum|||Week 0||||0.266
70954875|NCT01163292|141412705|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||Wilcoxon Rank Sum|||Week 26||||0.440
70954876|NCT01163292|141412705|SUPERIORITY_OR_OTHER|||||||0.609||95.0|||||Wilcoxon Rank Sum|||Week 52||||0.609
70954877|NCT02217475|141412714|SUPERIORITY||Odds Ratio (OR)|0.816||||0.5194|TWO_SIDED|95.0|0.439|1.516|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||1.516|0.439|0.5194
70954878|NCT02217475|141412715|SUPERIORITY||Odds Ratio (OR)|1.934||||0.0388|TWO_SIDED|95.0|1.035|3.614|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||3.614|1.035|0.0388
70954879|NCT02217475|141412716|SUPERIORITY||Odds Ratio (OR)|1.249||||0.592|TWO_SIDED|95.0|0.553|2.821|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||2.821|0.553|0.5920
70954880|NCT02217475|141412717|SUPERIORITY||Odds Ratio (OR)|1.396||||0.4941|TWO_SIDED|95.0|0.537|3.628|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||3.628|0.537|0.4941
70954881|NCT02217475|141412718|SUPERIORITY||Odds Ratio (OR)|1.142||||0.8434|TWO_SIDED|95.0|0.305|4.277|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||4.277|0.305|0.8434
70954882|NCT02217475|141412719|SUPERIORITY||Odds Ratio (OR)|2.201||||0.0234|TWO_SIDED|95.0|1.113|4.352|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||4.352|1.113|0.0234
70873676|NCT03975790|141232280|SUPERIORITY|||||||0.6496|||||||t-test|||||||0.6496
70873677|NCT03975790|141232281|SUPERIORITY|||||||0.5027|||||||t-test|||||||0.5027
70873678|NCT03975790|141232281|SUPERIORITY|||||||0.2375|||||||t-test|||||||0.2375
70873679|NCT03975790|141232281|SUPERIORITY|||||||0.5577|||||||t-test|||||||0.5577
70873680|NCT03975790|141232282|SUPERIORITY|||||||0.6908|||||||t-test|||||||0.6908
70954883|NCT02217475|141412720|SUPERIORITY||Odds Ratio (OR)|1.154||||0.7474|TWO_SIDED|95.0|0.484|2.752|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||2.752|0.484|0.7474
70873681|NCT03975790|141232282|SUPERIORITY|||||||0.0859|||||||t-test|||||||0.0859
70873682|NCT03975790|141232282|SUPERIORITY|||||||0.2764|||||||t-test|||||||0.2764
70873683|NCT03975790|141232283|SUPERIORITY|||||||0.1906|||||||t-test|||||||0.1906
70873684|NCT03975790|141232283|SUPERIORITY|||||||0.8744|||||||t-test|||||||0.8744
70873685|NCT03975790|141232283|SUPERIORITY|||||||0.3295|||||||t-test|||||||0.3295
70873686|NCT03975790|141232284|SUPERIORITY|||||||0.0056|||||||t-test|||All cause||||0.0056
70873687|NCT03975790|141232284|SUPERIORITY|||||||0.4222|||||||t-test|||All cause||||0.4222
70873688|NCT03975790|141232284|SUPERIORITY|||||||0.0041|||||||t-test|||All cause||||0.0041
70873689|NCT03975790|141232284|SUPERIORITY|||||||0.2277|||||||t-test|||RA related||||0.2277
70873690|NCT03975790|141232284|SUPERIORITY|||||||0.2812|||||||t-test|||RA related||||0.2812
70873691|NCT03975790|141232284|SUPERIORITY|||||||0.0772|||||||t-test|||RA related||||0.0772
70873692|NCT03975790|141232285|SUPERIORITY|||||||0.293|||||||t-test|||All cause||||0.2930
70873693|NCT03975790|141232285|SUPERIORITY|||||||0.439|||||||t-test|||All cause||||0.4390
70873694|NCT03975790|141232285|SUPERIORITY|||||||0.153|||||||t-test|||All cause||||0.1530
70873695|NCT03975790|141232285|SUPERIORITY|||||||0.9439|||||||t-test|||RA related||||0.9439
70873696|NCT03975790|141232285|SUPERIORITY|||||||0.4477|||||||t-test|||RA related||||0.4477
70873697|NCT03975790|141232285|SUPERIORITY|||||||0.4519|||||||t-test|||RA related||||0.4519
70873698|NCT03975790|141232286|SUPERIORITY|||||||0.9829|||||||Chi-squared|||Cardiovascular Disease||||0.9829
70873699|NCT03975790|141232286|SUPERIORITY|||||||0.8021|||||||Chi-squared|||Cardiovascular Disease||||0.8021
70873700|NCT03975790|141232286|SUPERIORITY|||||||0.8376|||||||Chi-squared|||Cardiovascular Disease||||0.8376
70873701|NCT03975790|141232286|SUPERIORITY|||||||0.5927|||||||Chi-squared|||COPD||||0.5927
70873702|NCT03975790|141232286|SUPERIORITY|||||||0.5202|||||||Chi-squared|||COPD||||0.5202
70873703|NCT03975790|141232286|SUPERIORITY|||||||0.8517|||||||Chi-squared|||COPD||||0.8517
70873704|NCT03975790|141232286|SUPERIORITY|||||||8.33|||||||Chi-squared|||Asthma||||8.33
70873705|NCT03975790|141232286|SUPERIORITY|||||||0.7483|||||||Chi-squared|||Asthma||||0.7483
70954884|NCT02643472|141412766|SUPERIORITY|||||||0.73|||||||Generalized Estimating Equations|In analyzing predicted means, results of Generalized Estimating Equations (GEE) modeling controlled for time from baseline at each assessment.||||||0.73
70954885|NCT02643472|141412767|SUPERIORITY|||||||0.12|||||||Generalized Estimating Equations|In analyzing predicted means, results of Generalized Estimating Equations (GEE) modeling controlled for time from baseline at each assessment.||STAI Y-1 data was used in these statistical analyses.||||0.12
70954886|NCT02643472|141412768|SUPERIORITY|||||||0.03|||||||Generalized Estimating Equations|In analyzing predicted means, results of Generalized Estimating Equations (GEE) modeling controlled for time from baseline at each assessment.||||||0.03
70954887|NCT02643472|141412771|SUPERIORITY|||||||0.06|||||||Generalized Estimating Equations|In analyzing predicted means, results of Generalized Estimating Equations (GEE) modeling controlled for time from baseline at each assessment.||||||0.06
70954888|NCT02643472|141412772|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
71146084|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.445|TWO_SIDED|95.0|-0.6|0.26||P-value is for prior use, 1 week. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 1.||0.26|-0.60|0.445
71146085|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58||||0.025|TWO_SIDED|95.0|0.07|1.09||P-value is for prior use, 2 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 2.||1.09|0.07|0.025
71146086|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.257|TWO_SIDED|95.0|-0.21|0.79||P-value is for prior use, 2 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 2.||0.79|-0.21|0.257
71146087|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.257|TWO_SIDED|95.0|-0.79|0.21||P-value is for prior use, 2 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 2.||0.21|-0.79|0.257
70873706|NCT03975790|141232286|SUPERIORITY|||||||0.9713|||||||Chi-squared|||Asthma||||0.9713
70954889|NCT02643472|141412773|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
70954890|NCT02643472|141412774|SUPERIORITY|||||||0.6|||||||Chi-squared|||||||0.60
70954891|NCT02643472|141412775|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||Infant development status was evaluated with Bayley subscales. Cognitive subscale.||||0.92
70954892|NCT02643472|141412775|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||Infant development status was evaluated with Bayley subscales. Language subscale.||||0.58
70954893|NCT02643472|141412775|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||Infant development status was evaluated with Bayley subscales. Motor subscale.||||0.87
70954894|NCT00673400|141412814|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||based on 28 pairwise matches|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Lifestyle (LS)||||0.1340
70954895|NCT00673400|141412814|SUPERIORITY_OR_OTHER|||||||0.088||95.0||||based on 29 matched pairs|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Coping/behavior (C/B)||||0.088
70954896|NCT00673400|141412814|SUPERIORITY_OR_OTHER|||||||0.0012||95.0||||based on 30 matched pairs|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Depression/self-perception (D/S)||||0.0012
70954897|NCT00673400|141412814|SUPERIORITY_OR_OTHER|||||||0.0074||95.0||||based on 30 matched pairs|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Embarrassment (E)||||0.0074
70954898|NCT00673400|141412817|SUPERIORITY_OR_OTHER||||||<|1e-07||95.0|||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method||||||<0.0000001
70954899|NCT00673400|141412817|SUPERIORITY_OR_OTHER||||||<|1e-07||95.0|||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method||||||<0.0000001
70954900|NCT00673400|141412817|SUPERIORITY_OR_OTHER||||||<|1e-07||95.0|||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method||||||<0.0000001
70954901|NCT00673400|141412818|SUPERIORITY_OR_OTHER||||||<|1e-07||95.0|||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method||||||<0.0000001
70954902|NCT00673400|141412818|SUPERIORITY_OR_OTHER||||||<|1e-07||95.0|||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method||||||<0.0000001
70954903|NCT00673400|141412818|SUPERIORITY_OR_OTHER||||||<|1e-07||95.0|||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method||||||<0.0000001
70873707|NCT03975790|141232286|SUPERIORITY|||||||0.9148|||||||Chi-squared|||Kidney disease||||0.9148
70873708|NCT03975790|141232286|SUPERIORITY|||||||0.7248|||||||Chi-squared|||Kidney disease||||0.7248
70873709|NCT03975790|141232286|SUPERIORITY|||||||0.82|||||||Chi-squared|||Kidney disease||||0.8200
70873710|NCT03975790|141232286|SUPERIORITY|||||||0.9657|||||||Chi-squared|||Diabetes||||0.9657
70873711|NCT03975790|141232286|SUPERIORITY|||||||0.9255|||||||Chi-squared|||Diabetes||||0.9255
70873712|NCT03975790|141232286|SUPERIORITY|||||||0.9575|||||||Chi-squared|||Diabetes||||0.9575
70873713|NCT03975790|141232286|SUPERIORITY|||||||0.941|||||||Chi-squared|||Depression||||0.9410
70873714|NCT03975790|141232286|SUPERIORITY|||||||0.9146|||||||Chi-squared|||Depression||||0.9146
70873715|NCT03975790|141232286|SUPERIORITY|||||||0.9641|||||||Chi-squared|||Depression||||0.9641
70873716|NCT03975790|141232286|SUPERIORITY|||||||0.2596|||||||Chi-squared|||Anxiety||||0.2596
70873717|NCT03975790|141232286|SUPERIORITY|||||||0.2228|||||||Chi-squared|||Anxiety||||0.2228
70873718|NCT03975790|141232286|SUPERIORITY|||||||0.7824|||||||Chi-squared|||Anxiety||||0.7824
70873719|NCT03975790|141232286|SUPERIORITY|||||||0.4184|||||||Chi-squared|||Liver disease||||0.4184
70873720|NCT03975790|141232286|SUPERIORITY|||||||0.4371|||||||Chi-squared|||Liver disease||||0.4371
70873721|NCT03975790|141232286|SUPERIORITY|||||||0.2074|||||||Chi-squared|||Liver disease||||0.2074
70873722|NCT03975790|141232286|SUPERIORITY|||||||0.785|||||||Chi-squared|||Sleep disorders||||0.7850
70873723|NCT03975790|141232286|SUPERIORITY|||||||0.1288|||||||Chi-squared|||Sleep disorders||||0.1288
70873724|NCT03975790|141232286|SUPERIORITY|||||||0.2839|||||||Chi-squared|||Sleep disorders||||0.2839
70873725|NCT03975790|141232287|SUPERIORITY|||||||0.2242|||||||Chi-squared|||||||0.2242
70873726|NCT03975790|141232287|SUPERIORITY|||||||0.0014|||||||Chi-squared|||||||0.0014
70873727|NCT03975790|141232287|SUPERIORITY|||||||0.0557|||||||Chi-squared|||||||0.0557
70873728|NCT03975790|141232288|SUPERIORITY|||||||0.5944|||||||Chi-squared|||Switch immediately||||0.5944
70873729|NCT03975790|141232288|SUPERIORITY|||||||0.9255|||||||Chi-squared|||Switch immediately||||0.9255
70873730|NCT03975790|141232288|SUPERIORITY|||||||0.7824|||||||Chi-squared|||Switch immediately||||0.7824
70873731|NCT03975790|141232288|SUPERIORITY|||||||0.3975|||||||Chi-squared|||Discontinue then switch||||0.3975
70873732|NCT03975790|141232288|SUPERIORITY|||||||0.0552|||||||Chi-squared|||Discontinue then switch||||0.0552
70873733|NCT03975790|141232288|SUPERIORITY|||||||0.3914|||||||Chi-squared|||Discontinue then switch||||0.3914
70954904|NCT00673400|141412819|SUPERIORITY_OR_OTHER|||||||0.65||95.0||||based on 28 pairwise matches|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Physical component summary (PCS)||||0.65
70954905|NCT00673400|141412819|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||based on 28 pairwise matches|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Mental component summary (MCS)||||0.010
70954906|NCT01680640|141412820|SUPERIORITY||Mean Difference (Net)|-3.8|STANDARD_DEVIATION|0.8|=|0.05|TWO_SIDED|95.0||||The threshold for statistical significance was p=0.05|Regression, Linear|||A total sample size of 100 participants, with a 14% drop out during the study and 43 participants in each group completing the study provided 85% power to detect a difference of 40% in liver fat (in the treatment arm compared with the placebo), using a power calculation test with a 0.05 two-sided significance level. For change in liver fat percentage (and other secondary outcomes), ANCOVA will also be undertaken to assess effect sizes in the intervention group and placebo.||||=0.05
70954907|NCT01680640|141412820|SUPERIORITY|For each primary outcome, a change variable was calculated as the difference between end of study and baseline measurements. Multiple regression analysis was used to assess the effect of synbiotic treatment on each of the change variables of interest.|Median Difference (Final Values)|-1.7|||<|0.001|TWO_SIDED||||||Regression, Linear|||||||<0.001
70954908|NCT01680640|141412821|SUPERIORITY|For each primary outcome, a change variable was calculated as the difference between end-of study and baseline measurements. Multiple regression analysis was used to assess the effect of synbiotic treatment on each of the change variables of interest.|Mean Difference (Final Values)|0.1||||1|TWO_SIDED||||||Regression, Linear|||||||1.00
70954909|NCT01680640|141412822|SUPERIORITY|For each primary outcome, a change variable was calculated as the difference between end of study and baseline measurements. Multiple regression analysis was used to assess the effect of synbiotic treatment on each of the change variables of interest.|Mean Difference (Final Values)|0.2||||0.8|TWO_SIDED||||||Regression, Linear|||||||0.80
71146088|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.075|TWO_SIDED|95.0|-0.05|1.04||P-value is for prior use, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 3.||1.04|-0.05|0.075
71146089|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.634|TWO_SIDED|95.0|-0.42|0.68||P-value is for prior use, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 3.||0.68|-0.42|0.634
70873734|NCT03975790|141232288|SUPERIORITY|||||||0.2036|||||||Chi-squared|||Discontinue then restart||||0.2036
70873735|NCT03975790|141232288|SUPERIORITY|||||||0.1336|||||||Chi-squared|||Discontinue then restart||||0.1336
70873736|NCT03975790|141232288|SUPERIORITY|||||||0.7095|||||||Chi-squared|||Discontinue then restart||||0.7095
70873737|NCT03975790|141232288|SUPERIORITY|||||||0.2241|||||||Chi-squared|||Discontinue without switch or restart||||0.2241
70954910|NCT01680640|141412823|SUPERIORITY|For each primary outcome, a change variable was calculated as the difference between end of study and baseline measurements. Multiple regression analysis was used to assess the effect of synbiotic treatment on each of the change variables of interest.|Median Difference (Final Values)|0.97|||<|0.001|TWO_SIDED||||||Beta-diversity indexes|Beta-diversity indexes were first visualized through a Principal Coordinates Analysis (PCoA)||||||<0.001
70954911|NCT00291642|141412840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.35|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-4.61|-2.09|||ANCOVA|||||-2.09|-4.61|<0.001
70954912|NCT00291642|141412840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.25|STANDARD_ERROR_OF_MEAN|0.637|<|0.001|TWO_SIDED|95.0|-4.5|-2.0|||ANCOVA|||||-2.00|-4.50|<0.001
70954913|NCT00291642|141412840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.13|STANDARD_ERROR_OF_MEAN|0.637|<|0.001|TWO_SIDED|95.0|-5.38|-2.88|||ANCOVA|||||-2.88|-5.38|<0.001
70954914|NCT00291642|141412840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.74|STANDARD_ERROR_OF_MEAN|0.637|<|0.001|TWO_SIDED|95.0|-4.99|-2.49|||ANCOVA|||||-2.49|-4.99|<0.001
70954915|NCT02576587|141412854|OTHER|Conditional logistic regression was used to assess the relationship of PAF and AHI on matched pairs of case and control.|Odds Ratio (OR)|0.98|STANDARD_ERROR_OF_MEAN|0.007||0.054|TWO_SIDED|95.0|0.97|1.0|||Conditional logistic regression|||||1.00|0.97|0.054
70954916|NCT02576587|141412854|OTHER|Conditional logistic regression was used to assess the relationship of PAF and LA volume on matched pairs of case and control.|Odds Ratio (OR)|1.02|STANDARD_ERROR_OF_MEAN|0.007||0.014|TWO_SIDED|95.0|1.0|1.03|||Conditional logistic regression|N = 270 (135 cases and 135 controls)||||1.03|1.00|0.014
70954917|NCT02576587|141412854|OTHER|Conditional logistic regression was used to assess the relationship of PAF and LA volume index on matched pairs of case and control.|Odds Ratio (OR)|1.03|STANDARD_ERROR_OF_MEAN|0.015||0.03|TWO_SIDED|95.0|1.0|1.06|||Conditional logistic regression|N=268 (134 cases and 134 controls)||||1.06|1.00|0.030
70873738|NCT03975790|141232288|SUPERIORITY|||||||0.0024|||||||Chi-squared|||Discontinue without switch or restart||||0.0024
70873739|NCT03975790|141232288|SUPERIORITY|||||||0.1204|||||||Chi-squared|||Discontinue without switch or restart||||0.1204
70873740|NCT03975790|141232289|SUPERIORITY|||||||0.8424|||||||Chi-squared|||||||0.8424
70873741|NCT03975790|141232289|SUPERIORITY|||||||0.3278|||||||Chi-squared|||||||0.3278
70873742|NCT03975790|141232289|SUPERIORITY|||||||0.3336|||||||Chi-squared|||||||0.3336
70873743|NCT03975790|141232290|SUPERIORITY|||||||0.2036|||||||Chi-squared|||||||0.2036
70873744|NCT03975790|141232290|SUPERIORITY|||||||0.1336|||||||Chi-squared|||||||0.1336
70873745|NCT03975790|141232290|SUPERIORITY|||||||0.7095|||||||Chi-squared|||||||0.7095
70873746|NCT03975790|141232292|SUPERIORITY||||||<|0.0001|||||||t-test|||||||<0.0001
70954918|NCT02576587|141412854|OTHER|Conditional logistic regression was used to assess the relationship of PAF and LA systolic strain apical four-chamber (A4C) on matched pairs of case and control.|Odds Ratio (OR)|0.99|STANDARD_ERROR_OF_MEAN|0.013||0.39|TWO_SIDED|95.0|0.96|1.01|||Conditional logistic regression|N=214 (107 cases and 107 controls)||||1.01|0.96|0.39
70954919|NCT02576587|141412854|OTHER|Conditional logistic regression was used to assess the relationship of PAF and LA systolic strain apical two-chamber (A2C) on matched pairs of case and control.|Odds Ratio (OR)|0.99|STANDARD_ERROR_OF_MEAN|0.013||0.49|TWO_SIDED|95.0|0.97|1.02|||Conditional logistic regression|N=212 (106 cases and 106 controls)||||1.02|0.97|0.49
70954920|NCT02576587|141412855|OTHER||median of change|3.4||||0.16|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test was used to compare pre- and post- treatment outcomes.|||Inter-Quartile Range of the change (post minus pre) is (-7.0, 13.7).|||0.16
70954921|NCT02576587|141412856|OTHER||median of change|1.8||||0.088|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test was used to compare pre- and post- treatment outcomes.|Inter-quartile range of the change (post minus pre) is (-2.0, 6.0).|||||0.088
70954922|NCT02576587|141412857|OTHER||median of change|-3.7||||0.006|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test was used to compare pre- and post- treatment outcomes.|Inter-quartile range of the change (post minus pre) is (-8.0, -0.57).|||||0.006
70954923|NCT02576587|141412858|OTHER||median of change|-0.7||||0.59|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test was used to compare pre- and post- treatment outcomes.|Inter-quartile range of the change (post minus pre) is (-6.2, 10.7).|||||0.59
70954924|NCT02576587|141412859|OTHER||mean of change|0.62|STANDARD_DEVIATION|4.2||0.65|TWO_SIDED||||||t-test, 2 sided|Paired t test was used to compare pre- and post- treatment outcomes.||||||0.65
70954925|NCT02576587|141412860|OTHER||mean of change|-1.7|STANDARD_DEVIATION|12.2||0.65|TWO_SIDED||||||t-test, 2 sided|Paired t test was used to compare pre- and post- treatment outcomes.||||||0.65
70954926|NCT00738894|141412876|SUPERIORITY|This is the first of two primary outcomes for this study. Assumptions for power calculations: expected event free for medical management 92% at 24 months; expected event free for device closure 96.4% at 24 months (55% risk reduction); 664 subjects randomly assigned 2:1 to device closure or medical management provides 80% power with 15% attrition (over 5 years) and 1-sided alpha = 0.024 to allow for interim analysis (interim analysis later rescinded from plan).|Hazard Ratio (HR)|0.23||||0.001|TWO_SIDED|95.0|0.09|0.62||1-sided p-value was adjusted for multiplicity with 2nd primary outcome using Dubey and Armitage-Parmer (D/AP) procedure.|Log Rank||Hazard ratio (test/control) obtained from Cox proportional hazards model with treatment arm as sole explanatory variable, the exponentiated coefficient of which provided the hazard ratio. Unadjusted for multiplicity.|"Test null hypothesis of equal or lower recurrent stroke-free survivorship for device closure compared to medical management.~H0: Sd(t) ≤ Sm(t) for all t, versus H1: Sd(t) \> Sm(t) for all t, where Sd(t) and Sm(t) are true Kaplan-Meier product-limit survivor functions for the device closure and medical management arms and t is time from randomization to event or censoring.~Event-free subjects were censored at time of last follow-up. Significance threshold (1-sided alpha) = 0.025."||0.62|0.09|0.001
70954927|NCT00738894|141412877|SUPERIORITY|This is the second of two primary outcomes for this study. Assumptions for power calculations: expected proportion of brain infarct is 3-7 times the clinical stroke rate; expected brain infarct proportion for medical management 14.5% (2.9% clinical stroke x 5); expected brain infarct for device closure 6.5% (55% risk reduction); 597 subjects (10% attrition from 664) provides 73% power with 1-sided alpha = 0.0125 (based conservatively on a Bonferroni adjustment of alpha/2).|Risk Difference (RD)|0.056||||0.024|TWO_SIDED|95.0|0.003|0.108||1-sided p-value was adjusted for multiplicity with 1st primary outcome using Dubey and Armitage-Parmer (D/AP) procedure.|z-test, 1-sided||Unadjusted for multiplicity.|"Test null hypothesis of equal or higher proportion with brain infarct for device closure compared to medical management.~H0: Pm - Pd ≤ 0, versus H1: Pm - Pd \> 0, where Pd and Pm are true proportions of subjects with brain infarct for the device closure and medical management arms.~Significance threshold (1-sided alpha) = 0.025."||0.108|0.003|0.024
70954928|NCT05745701|141412880|OTHER||test/reference ratios|195.9|||||TWO_SIDED|90.0|162.13|236.71||||||Natural loge transformed Cmax of PF-07081532 administered without cyclosporine (Reference) or coadministered with cyclosporine (Test) were analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test/Reference) and corresponding 90% CIs was obtained from the models. The ratios (and 90% CIs) were expressed as percentages.||236.71|162.13|
70873747|NCT03975790|141232292|SUPERIORITY||||||<|0.0001|||||||t-test|||||||<.0001
70873748|NCT03975790|141232292|SUPERIORITY||||||<|0.0001|||||||t-test|||||||<.0001
70873749|NCT03975790|141232293|SUPERIORITY|||||||0.0309|||||||Chi-squared|||Leflunomide||||0.0309
70954929|NCT05745701|141412880|OTHER||test/reference ratios|282.13|||||TWO_SIDED|90.0|258.81|307.55||||||Natural loge transformed Cmax of PF-07081532 administered without itraconazole (Reference) or coadministered with itraconazole (Test) were analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test/Reference) and corresponding 90% CIs was obtained from the models. The ratios (and 90% CIs) were expressed as percentages.||307.55|258.81|
70954930|NCT00719329|141412893|SUPERIORITY_OR_OTHER||Prevalence Rate Ratio|0.75|||||TWO_SIDED|95.0|0.7|0.81|||Binomial Regression, Log Link|General Estimating Equations (GEE) to account for clustered allocation|Prevalence Rate Ratio - Comparing Single CHX Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group||0.81|0.70|
70873750|NCT03975790|141232293|SUPERIORITY|||||||0.9978|||||||Chi-squared|||Leflunomide||||0.9978
70873751|NCT03975790|141232293|SUPERIORITY|||||||0.2629|||||||Chi-squared|||Leflunomide||||0.2629
70873752|NCT03975790|141232293|SUPERIORITY|||||||0.0225|||||||Chi-squared|||Sulfasalazine||||0.0225
70873753|NCT03975790|141232293|SUPERIORITY|||||||0.4456|||||||Chi-squared|||Sulfasalazine||||0.4456
70873754|NCT03975790|141232293|SUPERIORITY|||||||0.5065|||||||Chi-squared|||Sulfasalazine||||0.5065
70873755|NCT03975790|141232293|SUPERIORITY|||||||0.6617|||||||Chi-squared|||Hydroxychloroquine||||0.6617
70873756|NCT03975790|141232293|SUPERIORITY|||||||0.7309|||||||Chi-squared|||Hydroxychloroquine||||0.7309
70873757|NCT03975790|141232293|SUPERIORITY|||||||0.9861|||||||Chi-squared|||Hydroxychloroquine||||0.9861
70873758|NCT03975790|141232294|SUPERIORITY|||||||0.088|||||||Chi-squared|||||||0.0880
70873759|NCT03975790|141232294|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
70873760|NCT03975790|141232294|SUPERIORITY|||||||0.0065|||||||Chi-squared|||||||0.0065
70873761|NCT03975790|141232295|SUPERIORITY|||||||0.5157|||||||Chi-squared|||||||0.5157
70873762|NCT03975790|141232295|SUPERIORITY|||||||0.1231|||||||Chi-squared|||||||0.1231
70873763|NCT03975790|141232295|SUPERIORITY|||||||0.2109|||||||Chi-squared|||||||0.2109
70873764|NCT03975790|141232296|SUPERIORITY|||||||0.8424|||||||Chi-squared|||||||0.8424
70873765|NCT03975790|141232296|SUPERIORITY|||||||0.3278|||||||Chi-squared|||||||0.3278
70873766|NCT03975790|141232296|SUPERIORITY|||||||0.3336|||||||Chi-squared|||||||0.3336
70873767|NCT03975790|141232297|SUPERIORITY|||||||0.0654|||||||Chi-squared|||||||0.0654
70873768|NCT03975790|141232297|SUPERIORITY|||||||0.7315|||||||Chi-squared|||||||0.7315
70954931|NCT00719329|141412893|SUPERIORITY_OR_OTHER||Prevalence Rate Ratio|0.71|||||TWO_SIDED|95.0|0.66|0.77|||Binomial Regression, Log Link|General Estimating Equations (GEE) to account for clustered allocation|Prevalence Rate Ratio - Comparing Multiple CHX Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group||0.77|0.66|
70954932|NCT00719329|141412894|SUPERIORITY_OR_OTHER||Prevalence Rate Ratio|0.78|||||TWO_SIDED|95.0|0.74|0.82|||Binomial Regression, Log Link|Generalized Estimating Equations to account for clustered allocation|Prevalence Ratio Ratio - Comparing Single Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group||0.82|0.74|
70954933|NCT00719329|141412894|SUPERIORITY_OR_OTHER||Prevalence Rate Ratio|0.61|||||TWO_SIDED|95.0|0.57|0.65|||Binomial Regression, Log Link|Generalized Estimating Equations to account for clustered allocation|Prevalence Rate Ratio - Comparing Multiple Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group||0.65|0.57|
70954934|NCT00719329|141412895|SUPERIORITY_OR_OTHER||Prevalence Rate Ratio|0.92|||||TWO_SIDED|95.0|0.89|0.96|||Binomial Regression, Log Link|General Estimating Equations to adjust for clustered allocation|Prevalence Rate Ratio - Comparing Single Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group||0.96|0.89|
70954935|NCT00719329|141412895|SUPERIORITY_OR_OTHER||Prevalence Rate Ratio|0.57|||||TWO_SIDED|95.0|0.53|0.63|||Binomial Regression, Log Link|General Estimating Equations to account for clustered allocation|Prevalence Ratio Ratio - Comparing Multiple Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group||0.63|0.53|
70954936|NCT00422812|141412933|SUPERIORITY|||||||0.0012||||||Overall effect at 2 hr (by Cochran-Mantel-Haenszel) for TREATMENT|Cochran-Mantel-Haenszel|||||||0.0012
70954937|NCT00422812|141412934|SUPERIORITY|||||||0.281|||||||Fisher Exact|||||||0.281
70954938|NCT00422812|141412934|SUPERIORITY|||||||0.0226|||||||Fisher Exact|||||||0.0226
70954939|NCT00422812|141412934|SUPERIORITY|||||||0.0019|||||||Fisher Exact|||||||0.0019
70954940|NCT00422812|141412935|SUPERIORITY|||||||0.0007||||||Overall effect (0-4 hr) for TREATMENT by Log-rank p-value|Log Rank|There was no adjustment for multiple comparisons.||||||0.0007
71146090|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.193|TWO_SIDED|95.0|-0.91|0.19||P-value is for prior use, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 3.||0.19|-0.91|0.193
70954941|NCT00422812|141412935|SUPERIORITY|||||||0.0008|||||||Log Rank|No adjustments were made for multiple comparisons||||||0.0008
70954942|NCT00422812|141412935|SUPERIORITY|||||||0.0008||||||No adjustments were made for multiple comparisons|Log Rank|||||||0.0008
70954943|NCT00422812|141412935|SUPERIORITY|||||||0.0003||||||No adjustments were made for multiple comparisons|Log Rank|||||||0.0003
70954944|NCT01397422|141412936|SUPERIORITY||Least Squares Mean Difference|-11.3||||0.0051|TWO_SIDED|95.0|-19.1|-3.5|||ANCOVA|Change from baseline is a dependent variable, treatment group is a factor, and the baseline value is a covariate.||20 subjects per treatment arm provided 80% power using a 2-sided 2-sample test at 5% significance. The null hypothesis for the primary endpoint was that the response of the ADS-5102 340 mg group was equal to that of the placebo group.||-3.5|-19.1|0.0051
70954945|NCT01397422|141412936|SUPERIORITY||Least Squares Mean Difference|-10.0||||0.0131|TWO_SIDED|95.0|-17.8|-2.2|||ANCOVA|||||-2.2|-17.8|0.0131
70873769|NCT03975790|141232297|SUPERIORITY|||||||0.1897|||||||Chi-squared|||||||0.1897
70954946|NCT01397422|141412936|SUPERIORITY||Least Squares Mean Difference|-5.6||||0.1595|TWO_SIDED|95.0|-13.4|2.2|||ANCOVA|||||2.2|-13.4|0.1595
70954947|NCT01397422|141412937|SUPERIORITY||Least Squares Mean Difference|-0.3||||0.4314|TWO_SIDED|95.0|-1.1|0.5|||ANCOVA|||||0.5|-1.1|0.4314
70954948|NCT01397422|141412937|SUPERIORITY||Least Squares Mean Difference|0.3||||0.5223|TWO_SIDED|95.0|-0.5|1.0|||ANCOVA|||||1.0|-0.5|0.5223
70954949|NCT01397422|141412937|SUPERIORITY||Least Squares Mean Difference|0.2||||0.6298|TWO_SIDED|95.0|-0.6|1.0|||ANCOVA|Change from baseline is a dependent variable, treatment group is a factor, baseline value is a covariate||||1.0|-0.6|0.6298
70954950|NCT01397422|141412938|SUPERIORITY||Least Squares Mean Difference|-5.2||||0.0038|TWO_SIDED|95.0|-8.7|-1.7|||ANCOVA|||||-1.7|-8.7|0.0038
70954951|NCT01397422|141412938|SUPERIORITY||Least Squares Mean Difference|-6.4||||0.0004|TWO_SIDED|95.0|-9.8|-2.9|||ANCOVA|||||-2.9|-9.8|0.0004
70954952|NCT01397422|141412938|SUPERIORITY||Least Squares Mean Difference|-2.5||||0.1469|TWO_SIDED|95.0|-6.0|0.9|||ANCOVA|Change from baseline is a dependent variable, treatment group is a factor, and the baseline value is a covariate.||||0.9|-6.0|0.1469
70954953|NCT01397422|141412939|SUPERIORITY||Least Squares Mean Difference|3.0||||0.0078|TWO_SIDED|95.0|0.8|5.2|||ANCOVA|||||5.2|0.8|0.0078
70954954|NCT01397422|141412939|SUPERIORITY||Least Squares Mean Difference|2.7||||0.0179|TWO_SIDED|95.0|0.5|5.0|||ANCOVA|||||5.0|0.5|0.0179
70954955|NCT01397422|141412939|SUPERIORITY||Least Squares Mean Difference|3.3||||0.004|TWO_SIDED|95.0|1.1|5.5|||ANCOVA|Change from baseline is a dependent variable, treatment group is a factor, and the baseline value is a covariate||||5.5|1.1|0.0040
70954956|NCT01397422|141412940|SUPERIORITY||Least Squares Mean Difference|-2.2||||0.6355|TWO_SIDED|95.0|-11.2|6.9|||ANCOVA|||||6.9|-11.2|0.6355
70954957|NCT01397422|141412940|SUPERIORITY||Least Squares Mean Difference|1.7||||0.7053|TWO_SIDED|95.0|-7.2|10.6|||ANCOVA|||||10.6|-7.2|0.7053
70954958|NCT01397422|141412940|SUPERIORITY||Least Squares Mean Difference|1.2||||0.7862|TWO_SIDED|95.0|-7.7|10.1|||ANCOVA|Change from baseline is a dependent variable, treatment group is a factor, and the baseline value is a covariate||||10.1|-7.7|0.7862
70873770|NCT03975790|141232298|SUPERIORITY|||||||0.5146|||||||Chi-squared|||||||0.5146
70873771|NCT03975790|141232298|SUPERIORITY|||||||0.7121|||||||Chi-squared|||||||0.7121
70873772|NCT03975790|141232298|SUPERIORITY|||||||0.4434|||||||Chi-squared|||||||0.4434
70873773|NCT03975790|141232299|SUPERIORITY|||||||0.8966|||||||Chi-squared|||||||0.8966
70873774|NCT03975790|141232299|SUPERIORITY|||||||0.2105|||||||Chi-squared|||||||0.2105
70873775|NCT03975790|141232299|SUPERIORITY|||||||0.3336|||||||Chi-squared|||||||0.3336
70873776|NCT03975790|141232301|SUPERIORITY|||||||0.361|||||||Chi-squared|||||||0.3610
70873777|NCT03975790|141232301|SUPERIORITY|||||||0.4519|||||||Chi-squared|||||||0.4519
70873778|NCT03975790|141232301|SUPERIORITY|||||||0.9612|||||||Chi-squared|||||||0.9612
70873779|NCT03975790|141232302|SUPERIORITY|||||||0.8135|||||||Chi-squared|||||||0.8135
70873780|NCT03975790|141232302|SUPERIORITY|||||||0.591|||||||Chi-squared|||||||0.5910
70873781|NCT03975790|141232302|SUPERIORITY|||||||0.7635|||||||Chi-squared|||||||0.7635
70873782|NCT03975790|141232303|SUPERIORITY|||||||0.597|||||||Chi-squared|||||||0.5970
70873783|NCT03975790|141232303|SUPERIORITY|||||||0.7055|||||||Chi-squared|||||||0.7055
70873784|NCT03975790|141232304|SUPERIORITY|||||||0.5435|||||||Chi-squared|||||||0.5435
70873785|NCT03975790|141232304|SUPERIORITY|||||||0.679|||||||Chi-squared|||||||0.6790
70873786|NCT03975790|141232304|SUPERIORITY|||||||0.9676|||||||Chi-squared|||||||0.9676
70873787|NCT03975790|141232305|SUPERIORITY|||||||0.8035|||||||Chi-squared|||||||0.8035
70873788|NCT03975790|141232305|SUPERIORITY|||||||0.4184|||||||Chi-squared|||||||0.4184
70873789|NCT03975790|141232305|SUPERIORITY|||||||0.395|||||||Chi-squared|||||||0.3950
70873790|NCT03975790|141232307|SUPERIORITY|||||||0.7871|||||||Chi-squared|||||||0.7871
70873791|NCT03975790|141232307|SUPERIORITY|||||||0.0722|||||||Chi-squared|||||||0.0722
70873792|NCT03975790|141232307|SUPERIORITY|||||||0.181|||||||Chi-squared|||||||0.1810
71146091|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.688|TWO_SIDED|95.0|-0.46|0.7||P-value is for prior use, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 4.||0.70|-0.46|0.688
70873793|NCT03975790|141232308|SUPERIORITY|||||||0.1984|||||||Chi-squared|||||||0.1984
70873794|NCT03975790|141232308|SUPERIORITY|||||||0.2043|||||||Chi-squared|||||||0.2043
70873795|NCT03975790|141232308|SUPERIORITY|||||||0.0439|||||||Chi-squared|||||||0.0439
70873796|NCT03975790|141232309|SUPERIORITY|||||||0.1702|||||||Chi-squared|||||||0.1702
70873797|NCT03975790|141232309|SUPERIORITY|||||||0.5926|||||||Chi-squared|||||||0.5926
70873798|NCT03975790|141232309|SUPERIORITY|||||||0.3088|||||||Chi-squared|||||||0.3088
70873799|NCT03975790|141232310|SUPERIORITY|||||||0.9141|||||||Chi-squared|||||||0.9141
70873800|NCT03975790|141232310|SUPERIORITY|||||||0.7623|||||||Chi-squared|||||||0.7623
70873801|NCT03975790|141232310|SUPERIORITY|||||||0.8517|||||||Chi-squared|||||||0.8517
70873802|NCT03975790|141232311|SUPERIORITY|||||||0.1208|||||||Chi-squared|||||||0.1208
70873803|NCT03975790|141232311|SUPERIORITY|||||||0.0425|||||||Chi-squared|||||||0.0425
70873804|NCT03975790|141232311|SUPERIORITY|||||||0.0046|||||||Chi-squared|||||||0.0046
70873805|NCT03975790|141232312|SUPERIORITY|||||||0.8698|||||||t-test|||||||0.8698
70873806|NCT03975790|141232312|SUPERIORITY|||||||0.7391|||||||t-test|||||||0.7391
70873807|NCT03975790|141232312|SUPERIORITY|||||||0.7043|||||||t-test|||||||0.7043
70873808|NCT03975790|141232313|SUPERIORITY|||||||0.0536|||||||t-test|||||||0.0536
70873809|NCT03975790|141232313|SUPERIORITY|||||||0.9313|||||||t-test|||||||0.9313
70873810|NCT03975790|141232313|SUPERIORITY|||||||0.374|||||||t-test|||||||0.3740
70873811|NCT03975790|141232314|SUPERIORITY|||||||0.6963|||||||t-test|||||||0.6963
70873812|NCT03975790|141232314|SUPERIORITY|||||||0.9816|||||||t-test|||||||0.9816
70873813|NCT03975790|141232314|SUPERIORITY|||||||0.8349|||||||t-test|||||||0.8349
70873814|NCT03975790|141232315|SUPERIORITY|||||||0.0003|||||||t-test|||||||0.0003
70873815|NCT03975790|141232315|SUPERIORITY|||||||0.9431|||||||t-test|||||||0.9431
70873816|NCT03975790|141232315|SUPERIORITY|||||||0.2964|||||||t-test|||||||0.2964
70873817|NCT03975790|141232316|SUPERIORITY|||||||0.2614|||||||t-test|||||||0.2614
70873818|NCT03975790|141232316|SUPERIORITY|||||||0.0014|||||||t-test|||||||0.0014
70873819|NCT03975790|141232316|SUPERIORITY|||||||0.0535|||||||t-test|||||||0.0535
70873820|NCT03975790|141232317|SUPERIORITY|||||||0.0051|||||||t-test|||1 months before index date||||0.0051
70873821|NCT03975790|141232317|SUPERIORITY|||||||0.3041|||||||t-test|||1 months before index date||||0.3041
70873822|NCT03975790|141232317|SUPERIORITY|||||||0.4432|||||||t-test|||1 months before index date||||0.4432
70873823|NCT03975790|141232317|SUPERIORITY|||||||0.8641|||||||t-test|||2 months before index date||||0.8641
70873824|NCT03975790|141232317|SUPERIORITY|||||||0.0435|||||||t-test|||2 months before index date||||0.0435
70873825|NCT03975790|141232317|SUPERIORITY|||||||0.153|||||||t-test|||2 months before index date||||0.1530
70873826|NCT03975790|141232317|SUPERIORITY|||||||0.1188|||||||t-test|||3 months before index date||||0.1188
70873827|NCT03975790|141232317|SUPERIORITY|||||||0.6807|||||||t-test|||3 months before index date||||0.6807
70873828|NCT03975790|141232317|SUPERIORITY|||||||0.1772|||||||t-test|||3 months before index date||||0.1772
70873829|NCT03975790|141232317|SUPERIORITY|||||||0.6104|||||||t-test|||4 months before index date||||0.6104
70873830|NCT03975790|141232317|SUPERIORITY|||||||0.9564|||||||t-test|||4 months before index date||||0.9564
70873831|NCT03975790|141232317|SUPERIORITY|||||||0.7688|||||||t-test|||4 months before index date||||0.7688
70873832|NCT03975790|141232317|SUPERIORITY|||||||0.5685|||||||t-test|||5 months before index date||||0.5685
70954959|NCT01397422|141412941|SUPERIORITY|||||||0.0036|||||||Cochran-Mantel-Haenszel|||||||0.0036
71146092|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.944|TWO_SIDED|95.0|-0.6|0.56||P-value is for prior use, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 4.||0.56|-0.60|0.944
71146093|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.64|TWO_SIDED|95.0|-0.73|0.45||P-value is for prior use, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 4.||0.45|-0.73|0.640
70873833|NCT03975790|141232317|SUPERIORITY|||||||0.5122|||||||t-test|||5 months before index date||||0.5122
70954960|NCT01397422|141412941|SUPERIORITY|||||||0.2158|||||||Cochran-Mantel-Haenszel|||||||0.2158
71146094|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.439|TWO_SIDED|95.0|-0.37|0.84||P-value is for prior use, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 5.||0.84|-0.37|0.439
71146095|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.461|TWO_SIDED|95.0|-0.38|0.84||P-value is for prior use, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 5.||0.84|-0.38|0.461
71146096|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.976|TWO_SIDED|95.0|-0.62|0.6||P-value is for prior use, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 5.||0.60|-0.62|0.976
70954961|NCT01397422|141412941|SUPERIORITY|||||||0.1042|||||||Cochran-Mantel-Haenszel|Equally spaced scores||||||0.1042
70873834|NCT03975790|141232317|SUPERIORITY|||||||0.4321|||||||t-test|||5 months before index date||||0.4321
70873835|NCT03975790|141232317|SUPERIORITY|||||||0.7892|||||||t-test|||6 months before index date||||0.7892
70873836|NCT03975790|141232317|SUPERIORITY|||||||0.2874|||||||t-test|||6 months before index date||||0.2874
70873837|NCT03975790|141232317|SUPERIORITY|||||||0.2662|||||||t-test|||6 months before index date||||0.2662
70873838|NCT03975790|141232317|SUPERIORITY|||||||0.3091|||||||t-test|||7 months before index date||||0.3091
70873839|NCT03975790|141232317|SUPERIORITY|||||||0.5783|||||||t-test|||7 months before index date||||0.5783
70873840|NCT03975790|141232317|SUPERIORITY|||||||0.4021|||||||t-test|||7 months before index date||||0.4021
70873841|NCT03975790|141232317|SUPERIORITY|||||||0.767|||||||t-test|||8 months before index date||||0.7670
70873842|NCT03975790|141232317|SUPERIORITY|||||||0.6978|||||||t-test|||8 months before index date||||0.6978
70873843|NCT03975790|141232317|SUPERIORITY|||||||0.6328|||||||t-test|||8 months before index date||||0.6328
70873844|NCT03975790|141232317|SUPERIORITY|||||||0.0541|||||||t-test|||9 months before index date||||0.0541
70873845|NCT03975790|141232317|SUPERIORITY|||||||0.6999|||||||t-test|||9 months before index date||||0.6999
70873846|NCT03975790|141232317|SUPERIORITY|||||||0.359|||||||t-test|||9 months before index date||||0.3590
70873847|NCT03975790|141232317|SUPERIORITY|||||||0.936|||||||t-test|||10 months before index date||||0.9360
70873848|NCT03975790|141232317|SUPERIORITY|||||||0.626|||||||t-test|||10 months before index date||||0.6260
70873849|NCT03975790|141232317|SUPERIORITY|||||||0.7797|||||||t-test|||10 months before index date||||0.7797
70873850|NCT03975790|141232317|SUPERIORITY|||||||0.0934|||||||t-test|||11 months before index date||||0.0934
70873851|NCT03975790|141232317|SUPERIORITY|||||||0.396|||||||t-test|||11 months before index date||||0.3960
70873852|NCT03975790|141232317|SUPERIORITY|||||||0.4292|||||||t-test|||11 months before index date||||0.4292
70873853|NCT03975790|141232317|SUPERIORITY|||||||0.854|||||||t-test|||12 months before index date||||0.8540
70873854|NCT03975790|141232317|SUPERIORITY|||||||0.96|||||||t-test|||12 months before index date||||0.9600
70873855|NCT03975790|141232317|SUPERIORITY|||||||0.9374|||||||t-test|||12 months before index date||||0.9374
71146097|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.829|TWO_SIDED|95.0|-0.55|0.68||P-value is for prior use, 6 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 6.||0.68|-0.55|0.829
71146098|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.713|TWO_SIDED|95.0|-0.5|0.74||P-value is for prior use, 6 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 6.||0.74|-0.50|0.713
71146099|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.878|TWO_SIDED|95.0|-0.58|0.67||P-value is for prior use, 6 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 6.||0.67|-0.58|0.878
70873856|NCT03975790|141232317|SUPERIORITY|||||||0.6674|||||||t-test|||1 month after index date||||0.6674
70873857|NCT03975790|141232317|SUPERIORITY|||||||0.0776|||||||t-test|||1 month after index date||||0.0776
70873858|NCT03975790|141232317|SUPERIORITY|||||||0.335|||||||t-test|||1 month after index date||||0.3350
70873859|NCT03975790|141232317|SUPERIORITY|||||||0.8461|||||||t-test|||2 month after index date||||0.8461
70873860|NCT03975790|141232317|SUPERIORITY|||||||0.8111|||||||t-test|||2 month after index date||||0.8111
70873861|NCT03975790|141232317|SUPERIORITY|||||||0.7267|||||||t-test|||2 month after index date||||0.7267
70873862|NCT03975790|141232317|SUPERIORITY|||||||0.2453|||||||t-test|||3 month after index date||||0.2453
70873863|NCT03975790|141232317|SUPERIORITY|||||||0.5889|||||||t-test|||3 month after index date||||0.5889
70873864|NCT03975790|141232317|SUPERIORITY|||||||0.4162|||||||t-test|||3 month after index date||||0.4162
70873865|NCT03975790|141232317|SUPERIORITY|||||||0.0307|||||||t-test|||4 month after index date||||0.0307
70873866|NCT03975790|141232317|SUPERIORITY|||||||0.1147|||||||t-test|||4 month after index date||||0.1147
70873867|NCT03975790|141232317|SUPERIORITY|||||||0.9481|||||||t-test|||4 month after index date||||0.9481
70873868|NCT03975790|141232317|SUPERIORITY|||||||0.4455|||||||t-test|||5 month after index date||||0.4455
70873869|NCT03975790|141232317|SUPERIORITY|||||||0.9445|||||||t-test|||5 month after index date||||0.9445
71146100|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.447|TWO_SIDED|95.0|-0.38|0.85||P-value is for prior use, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 7.||0.85|-0.38|0.447
71146101|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.511|TWO_SIDED|95.0|-0.41|0.83||P-value is for prior use, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 7.||0.83|-0.41|0.511
71146102|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.924|TWO_SIDED|95.0|-0.65|0.59||P-value is for prior use, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 7.||0.59|-0.65|0.924
71146103|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43||||0.185|TWO_SIDED|95.0|-0.2|1.06||P-value is for prior use, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 8.||1.06|-0.20|0.185
71146104|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.403|TWO_SIDED|95.0|-0.37|0.91||P-value is for prior use, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 8.||0.91|-0.37|0.403
70873870|NCT03975790|141232317|SUPERIORITY|||||||0.6191|||||||t-test|||5 month after index date||||0.6191
70873871|NCT03975790|141232317|SUPERIORITY|||||||0.0805|||||||t-test|||6 month after index date||||0.0805
70873872|NCT03975790|141232317|SUPERIORITY|||||||0.7037|||||||t-test|||6 month after index date||||0.7037
70873873|NCT03975790|141232317|SUPERIORITY|||||||0.4288|||||||t-test|||6 month after index date||||0.4288
70873874|NCT03975790|141232317|SUPERIORITY|||||||0.3731|||||||t-test|||7 month after index date||||0.3731
70873875|NCT03975790|141232317|SUPERIORITY|||||||0.4803|||||||t-test|||7 month after index date||||0.4803
70873876|NCT03975790|141232317|SUPERIORITY|||||||0.5831|||||||t-test|||7 month after index date||||0.5831
70873877|NCT03975790|141232317|SUPERIORITY|||||||0.0944|||||||t-test|||8 month after index date||||0.0944
71146105|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.636|TWO_SIDED|95.0|-0.79|0.49||P-value is for prior use, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 8.||0.49|-0.79|0.636
70873878|NCT03975790|141232317|SUPERIORITY|||||||0.88|||||||t-test|||8 month after index date||||0.8800
70873879|NCT03975790|141232317|SUPERIORITY|||||||0.4949|||||||t-test|||8 month after index date||||0.4949
70873880|NCT03975790|141232317|SUPERIORITY|||||||0.6373|||||||t-test|||9 month after index date||||0.6373
70873881|NCT03975790|141232317|SUPERIORITY|||||||0.0497|||||||t-test|||9 month after index date||||0.0497
70873882|NCT03975790|141232317|SUPERIORITY|||||||0.1695|||||||t-test|||9 month after index date||||0.1695
70873883|NCT03975790|141232317|SUPERIORITY|||||||0.6373|||||||t-test|||10 month after index date||||0.6373
70873884|NCT03975790|141232317|SUPERIORITY|||||||0.7866|||||||t-test|||10 month after index date||||0.7866
70873885|NCT03975790|141232317|SUPERIORITY|||||||0.7643|||||||t-test|||10 months after index date||||0.7643
70873886|NCT03975790|141232317|SUPERIORITY|||||||0.2307|||||||t-test|||11 month after index date||||0.2307
70873887|NCT03975790|141232317|SUPERIORITY|||||||0.6712|||||||t-test|||11 month after index date||||0.6712
70873888|NCT03975790|141232317|SUPERIORITY|||||||0.6953|||||||t-test|||11 months after index date||||0.6953
70873889|NCT03975790|141232317|SUPERIORITY|||||||0.3675|||||||t-test|||12 month after index date||||0.3675
70873890|NCT03975790|141232317|SUPERIORITY|||||||0.8027|||||||t-test|||12 month after index date||||0.8027
70873891|NCT03975790|141232317|SUPERIORITY|||||||0.4817|||||||t-test|||12 month after index date||||0.4817
70873892|NCT03975790|141232318|SUPERIORITY|||||||0.0063|||||||t-test|||1 month before index date||||0.0063
70873893|NCT03975790|141232318|SUPERIORITY|||||||0.0162|||||||t-test|||1 month before index date||||0.0162
70873894|NCT03975790|141232318|SUPERIORITY|||||||0.8715|||||||t-test|||1 month before index date||||0.8715
70873895|NCT03975790|141232318|SUPERIORITY|||||||0.2799|||||||t-test|||2 months before index date||||0.2799
70873896|NCT03975790|141232318|SUPERIORITY|||||||0.0126|||||||t-test|||2 months before index date||||0.0126
71146106|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.304|TWO_SIDED|95.0|-0.3|0.95||P-value is for prior use, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 9.||0.95|-0.30|0.304
71146107|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.295|TWO_SIDED|95.0|-0.29|0.97||P-value is for prior use, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 9.||0.97|-0.29|0.295
71146108|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.975|TWO_SIDED|95.0|-0.62|0.64||P-value is for prior use, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 9.||0.64|-0.62|0.975
71146109|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.349|TWO_SIDED|95.0|-0.33|0.93||P-value is for prior use, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 10.||0.93|-0.33|0.349
71146110|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.351|TWO_SIDED|95.0|-0.34|0.94||P-value is for prior use, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 10.||0.94|-0.34|0.351
71146111|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.992|TWO_SIDED|95.0|-0.64|0.65||P-value is for prior use, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 10.||0.65|-0.64|0.992
71146112|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.681|TWO_SIDED|95.0|-0.5|0.77||P-value is for prior use, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 11.||0.77|-0.50|0.681
71146113|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.569|TWO_SIDED|95.0|-0.46|0.83||P-value is for prior use, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 11.||0.83|-0.46|0.569
71146114|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.871|TWO_SIDED|95.0|-0.6|0.7||P-value is for prior use, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 11.||0.70|-0.60|0.871
71146115|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.675|TWO_SIDED|95.0|-0.5|0.78||P-value is for prior use, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 12.||0.78|-0.50|0.675
70873897|NCT03975790|141232318|SUPERIORITY|||||||0.2126|||||||t-test|||2 months before index date||||0.2126
70873898|NCT03975790|141232318|SUPERIORITY|||||||0.7004|||||||t-test|||3 months before index date||||0.7004
70954962|NCT00513305|141412962|SUPERIORITY_OR_OTHER|||||||0.425|TWO_SIDED|95.0||||The p-value is from the Pearson chi-square test for testing the equality of two binomial proportions, assuming normal approximation of the binomial proportions.|Chi-squared|There were no adjustments for covariates. Since the primary endpoint was prespecified, no adjustment for multiplicity of endpoints was introduced||The hypothesis of equal complete remission rates between the two treatment groups was tested using a 2-sided, normal approximation to the difference in binomial proportions test with two-sided alpha equal to 0.05.||||0.425
70954963|NCT00513305|141412963|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.027||||0.829|TWO_SIDED|95.0|0.535|1.973|||Log Rank|||||1.973|0.535|0.829
70954964|NCT00513305|141412964|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|2.31||||0.527|TWO_SIDED|95.0|0.16|33.343|||Log Rank||Estimate based on Cox Proportional Hazards Model adjusting for age, Eastern Cooperative Oncology Group (ECOG) status, white blood count and presence of antecedent hematologic disorder.|||33.343|0.160|0.527
70954965|NCT00513305|141412967|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.027||||0.8289|TWO_SIDED|95.0|0.535|1.973|||Log Rank||Estimate based on Cox Proportional Hazards Model adjusting for age, Eastern Cooperative Oncology Group (ECOG) status, white blood count and presence of antecedent hematologic disorder.|||1.973|0.535|0.8289
70954966|NCT04688320|141413007|NON_INFERIORITY|The margin of the non-inferiority was established as a difference in the primary efficacy endpoints between compared groups|Odds Ratio (OR)|0.75|||<|0.05|TWO_SIDED|95.0|0.11|4.52|||Welch's t-test|||||4.52|0.11|<0.05
70954967|NCT03798691|141413017|SUPERIORITY|||||||0.16|||||||Mann-Whitney U test|||one month after series completion of two dose series||||0.16
70954968|NCT01241604|141413130|EQUIVALENCE|Equivalent non-parametric tests||||||0.753|||||||Wilcoxon signed ranks test|||||||.753
70954969|NCT01865747|141413160|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.45|0.74|||Log Rank|The Log-Rank Test was stratified by the Memorial Sloan-Kettering Cancer Center (MSKCC) group and number of prior VEGFR TKIs.||||0.74|0.45|<0.0001
71146116|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.823|TWO_SIDED|95.0|-0.57|0.72||P-value is for prior use, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 12.||0.72|-0.57|0.823
71146117|NCT00385671|141785564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.85|TWO_SIDED|95.0|-0.72|0.59||P-value is for prior use, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 12.||0.59|-0.72|0.850
71146118|NCT00385671|141785566|SUPERIORITY_OR_OTHER|||||||0.448||95.0||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in diastolic blood pressure.||||0.448
70873899|NCT03975790|141232318|SUPERIORITY|||||||0.1476|||||||t-test|||3 months before index date||||0.1476
70873900|NCT03975790|141232318|SUPERIORITY|||||||0.2057|||||||t-test|||3 months before index date||||0.2057
70954970|NCT01865747|141413161|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0003|TWO_SIDED|95.0|0.53|0.83|||Log Rank|The Log-Rank test was stratified by the Memorial Sloan-Kettering Cancer Center (MSKCC) risk group and number of prior VEGFR TKIs.||||0.83|0.53|0.0003
70954971|NCT01865747|141413162|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70873901|NCT03975790|141232318|SUPERIORITY|||||||0.2905|||||||t-test|||4 months before index date||||0.2905
70954972|NCT01133418|141413176|SUPERIORITY_OR_OTHER|||||||0.36||||||a priori threshold for statistical significance was .05|General Linear Model|||||||.36
70873902|NCT03975790|141232318|SUPERIORITY|||||||0.8273|||||||t-test|||4 months before index date||||0.8273
70873903|NCT03975790|141232318|SUPERIORITY|||||||0.627|||||||t-test|||4 months before index date||||0.6270
70873904|NCT03975790|141232318|SUPERIORITY|||||||0.3256|||||||t-test|||5 months before index date||||0.3256
70873905|NCT03975790|141232318|SUPERIORITY|||||||0.5631|||||||t-test|||5 months before index date||||0.5631
70873906|NCT03975790|141232318|SUPERIORITY|||||||0.4491|||||||t-test|||5 months before index date||||0.4491
70873907|NCT03975790|141232318|SUPERIORITY|||||||0.2009|||||||t-test|||6 months before index date||||0.2009
70873908|NCT03975790|141232318|SUPERIORITY|||||||0.3011|||||||t-test|||6 months before index date||||0.3011
70873909|NCT03975790|141232318|SUPERIORITY|||||||0.2065|||||||t-test|||6 months before index date||||0.2065
70873910|NCT03975790|141232318|SUPERIORITY|||||||0.6098|||||||t-test|||7 months before index date||||0.6098
70954973|NCT01133418|141413177|SUPERIORITY_OR_OTHER|||||||0.86|||||||General Linear Model|||||||.86
70954974|NCT01133418|141413178|SUPERIORITY_OR_OTHER|||||||0.79|||||||General Linear Model|||||||.79
70954975|NCT01133418|141413179|SUPERIORITY_OR_OTHER|||||||0.77|||||||General Linear Model|||||||.77
70954976|NCT00611975|141413180|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.8|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||>0.8
70954977|NCT00611975|141413180|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.4|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||>0.4
71146119|NCT00385671|141785566|SUPERIORITY_OR_OTHER|||||||0.118||95.0||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in diastolic blood pressure.||||0.118
71146120|NCT00385671|141785566|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in diastolic blood pressure.||||0.021
71146121|NCT00385671|141785566|SUPERIORITY_OR_OTHER|||||||0.537||95.0||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in systolic blood pressure.||||0.537
71146122|NCT00385671|141785566|SUPERIORITY_OR_OTHER|||||||0.911||95.0||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in systolic blood pressure.||||0.911
71146123|NCT00385671|141785566|SUPERIORITY_OR_OTHER|||||||0.627||95.0||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in systolic blood pressure.||||0.627
71146124|NCT00385671|141785567|SUPERIORITY_OR_OTHER|||||||0.078||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in heart rate.||||0.078
71146125|NCT00385671|141785567|SUPERIORITY_OR_OTHER|||||||0.13||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in heart rate.||||0.130
71146126|NCT00385671|141785567|SUPERIORITY_OR_OTHER|||||||0.85||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in heart rate.||||0.850
71146127|NCT00385671|141785568|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in body weight.||||<0.001
70873911|NCT03975790|141232318|SUPERIORITY|||||||0.2586|||||||t-test|||7 months before index date||||0.2586
71146128|NCT00385671|141785568|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in body weight.||||<0.001
70873912|NCT03975790|141232318|SUPERIORITY|||||||0.4074|||||||t-test|||7 months before index date||||0.4074
70873913|NCT03975790|141232318|SUPERIORITY|||||||0.0345|||||||t-test|||8 months before index date||||0.0345
70873914|NCT03975790|141232318|SUPERIORITY|||||||0.4377|||||||t-test|||8 months before index date||||0.4377
70873915|NCT03975790|141232318|SUPERIORITY|||||||0.7191|||||||t-test|||8 months before index date||||0.7191
70873916|NCT03975790|141232318|SUPERIORITY|||||||0.0199|||||||t-test|||9 months before index date||||0.0199
70873917|NCT03975790|141232318|SUPERIORITY|||||||0.1032|||||||t-test|||9 months before index date||||0.1032
70873918|NCT03975790|141232318|SUPERIORITY|||||||0.904|||||||t-test|||9 months before index date||||0.9040
70954978|NCT00611975|141413181|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.6|||||||Mixed Models Analysis|||Asex questionnaires were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for ASEX scores were re-assigned to phase based on time to onset of next menstrual period. Follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-2 days before NMP).||||>0.6
71146129|NCT00385671|141785568|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in body weight.||||0.011
71146130|NCT00385671|141785569|SUPERIORITY_OR_OTHER|||||||0.83||95.0||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated diastolic blood pressure.||||0.830
71146131|NCT00385671|141785569|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated diastolic blood pressure.||||1.00
70873919|NCT03975790|141232318|SUPERIORITY|||||||0.0316|||||||t-test|||10 months before index date||||0.0316
70873920|NCT03975790|141232318|SUPERIORITY|||||||0.6748|||||||t-test|||10 months before index date||||0.6748
70873921|NCT03975790|141232318|SUPERIORITY|||||||0.2679|||||||t-test|||10 months before index date||||0.2679
70954979|NCT00611975|141413181|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.6|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on ASEX scores||||>0.6
70954980|NCT00611975|141413182|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||<.01
70954981|NCT00611975|141413182|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||<0.01
71146132|NCT00385671|141785569|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated diastolic blood pressure.||||1.00
70873922|NCT03975790|141232318|SUPERIORITY|||||||0.501|||||||t-test|||11 months before index date||||0.5010
70873923|NCT03975790|141232318|SUPERIORITY|||||||0.3228|||||||t-test|||11 months before index date||||0.3228
70873924|NCT03975790|141232318|SUPERIORITY|||||||0.7881|||||||t-test|||11 months before index date||||0.7881
70873925|NCT03975790|141232318|SUPERIORITY|||||||0.0876|||||||t-test|||12 months before index date||||0.0876
70873926|NCT03975790|141232318|SUPERIORITY|||||||0.1226|||||||t-test|||12 months before index date||||0.1226
70873927|NCT03975790|141232318|SUPERIORITY|||||||0.9753|||||||t-test|||12 months before index date||||0.9753
70873928|NCT03975790|141232318|SUPERIORITY|||||||0.0336|||||||t-test|||1 month after index date||||0.0336
70873929|NCT03975790|141232318|SUPERIORITY|||||||0.2551|||||||t-test|||1 month after index date||||0.2551
70873930|NCT03975790|141232318|SUPERIORITY|||||||0.6189|||||||t-test|||1 month after index date||||0.6189
70873931|NCT03975790|141232318|SUPERIORITY|||||||0.7051|||||||t-test|||2 months after index date||||0.7051
70873932|NCT03975790|141232318|SUPERIORITY|||||||0.9775|||||||t-test|||2 months after index date||||0.9775
70873933|NCT03975790|141232318|SUPERIORITY|||||||0.7643|||||||t-test|||2 months after index date||||0.7643
70873934|NCT03975790|141232318|SUPERIORITY|||||||0.2953|||||||t-test|||3 months after index date||||0.2953
70873935|NCT03975790|141232318|SUPERIORITY|||||||0.6257|||||||t-test|||3 months after index date||||0.6257
70873936|NCT03975790|141232318|SUPERIORITY|||||||0.4753|||||||t-test|||3 months after index date||||0.4753
70873937|NCT03975790|141232318|SUPERIORITY|||||||0.0926|||||||t-test|||4 months after index date||||0.0926
70873938|NCT03975790|141232318|SUPERIORITY|||||||0.0013|||||||t-test|||4 months after index date||||0.0013
70873939|NCT03975790|141232318|SUPERIORITY|||||||0.0065|||||||t-test|||4 months after index date||||0.0065
70873940|NCT03975790|141232318|SUPERIORITY|||||||0.2212|||||||t-test|||5 months after index date||||0.2212
70873941|NCT03975790|141232318|SUPERIORITY|||||||0.9688|||||||t-test|||5 months after index date||||0.9688
70873942|NCT03975790|141232318|SUPERIORITY|||||||0.5647|||||||t-test|||5 months after index date||||0.5647
70873943|NCT03975790|141232318|SUPERIORITY|||||||0.0023|||||||t-test|||6 months after index date||||0.0023
70873944|NCT03975790|141232318|SUPERIORITY|||||||0.1142|||||||t-test|||6 months after index date||||0.1142
70873945|NCT03975790|141232318|SUPERIORITY|||||||0.3842|||||||t-test|||6 months after index date||||0.3842
70873946|NCT03975790|141232318|SUPERIORITY|||||||0.9097|||||||t-test|||7 months after index date||||0.9097
70873947|NCT03975790|141232318|SUPERIORITY|||||||0.3885|||||||t-test|||7 months after index date||||0.3885
70873948|NCT03975790|141232318|SUPERIORITY|||||||0.3834|||||||t-test|||7 months after index date||||0.3834
70873949|NCT03975790|141232318|SUPERIORITY|||||||0.3075|||||||t-test|||8 months after index date||||0.3075
70873950|NCT03975790|141232318|SUPERIORITY|||||||0.9075|||||||t-test|||8 months after index date||||0.9075
70873951|NCT03975790|141232318|SUPERIORITY|||||||0.5993|||||||t-test|||8 months after index date||||0.5993
70873952|NCT03975790|141232318|SUPERIORITY|||||||0.0775|||||||t-test|||9 months after index date||||0.0775
70873953|NCT03975790|141232318|SUPERIORITY|||||||0.1536|||||||t-test|||9 months after index date||||0.1536
70873954|NCT03975790|141232318|SUPERIORITY|||||||0.8553|||||||t-test|||9 months after index date||||0.8553
70873955|NCT03975790|141232318|SUPERIORITY|||||||0.6295|||||||t-test|||10 months after index date||||0.6295
70873956|NCT03975790|141232318|SUPERIORITY|||||||0.0551|||||||t-test|||10 months after index date||||0.0551
70873957|NCT03975790|141232318|SUPERIORITY|||||||0.2215|||||||t-test|||10 months after index date||||0.2215
70873958|NCT03975790|141232318|SUPERIORITY|||||||0.1948|||||||t-test|||11 months after index date||||0.1948
70873959|NCT03975790|141232318|SUPERIORITY|||||||0.6621|||||||t-test|||11 months after index date||||0.6621
70873960|NCT03975790|141232318|SUPERIORITY|||||||0.6629|||||||t-test|||11 months after index date||||0.6629
70873961|NCT03975790|141232318|SUPERIORITY|||||||0.5699|||||||t-test|||12 months after index date||||0.5699
70873962|NCT03975790|141232318|SUPERIORITY|||||||0.7105|||||||t-test|||12 months after index date||||0.7105
70873963|NCT03975790|141232318|SUPERIORITY|||||||0.5965|||||||t-test|||12 months after index date||||0.5965
70873964|NCT04493281|141232346|EQUIVALENCE|The analysis was performed by analysis of variance (ANOVA), which included factors accounting for the following sources of variation: sequence, subjects nested in sequences, period, and treatment. For bioequivalence, the 90% CIs of the geometric mean ratio of AUC0-t for oral suspension and intravenous formulation were required to be within the range of 0.80 to 1.25.|Ratio (PO/IV)|0.97|||||TWO_SIDED|90.0|0.91|1.04||||||||1.04|0.91|
70873965|NCT04493281|141232347|EQUIVALENCE|The analysis was performed by analysis of variance (ANOVA), which included factors accounting for the following sources of variation: sequence, subjects nested in sequences, period, and treatment. For bioequivalence, the 90% CIs of the geometric mean ratio of AUC0-inf for oral suspension and intravenous formulation were required to be within the range of 0.80 to 1.25.|Ratio (PO/IV)|0.98|||||TWO_SIDED|90.0|0.92|1.04||||||||1.04|0.92|
70873966|NCT04493281|141232348|EQUIVALENCE|The analysis was performed by analysis of variance (ANOVA), which included factors accounting for the following sources of variation: sequence, subjects nested in sequences, period, and treatment. For bioequivalence, the 90% CIs of the geometric mean ratio of Cmax for oral suspension and intravenous formulation were required to be within the range of 0.80 to 1.25.|Ratio (PO/IV)|1.22|||||TWO_SIDED|90.0|1.09|1.36||||||||1.36|1.09|
70954982|NCT00611975|141413183|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.4|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||>0.4
70954983|NCT00611975|141413183|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||<.0001
71146133|NCT00385671|141785569|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated systolic blood pressure.||||0.060
71146134|NCT00385671|141785569|SUPERIORITY_OR_OTHER|||||||0.502||95.0||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated systolic blood pressure.||||0.502
71146135|NCT00385671|141785569|SUPERIORITY_OR_OTHER|||||||0.376||95.0||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated systolic blood pressure.||||0.376
71146136|NCT00385671|141785570|SUPERIORITY_OR_OTHER|||||||0.281||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated heart rate.||||0.281
71146137|NCT00385671|141785570|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated heart rate.||||0.060
71146138|NCT00385671|141785570|SUPERIORITY_OR_OTHER|||||||0.596||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated heart rate.||||0.596
71146139|NCT00385671|141785571|SUPERIORITY_OR_OTHER|||||||0.332||95.0||||P-value is for high. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of patients with treatment-emergent high body weight.||||0.332
71146140|NCT00385671|141785571|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||P-value is for high. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of patients with treatment-emergent high body weight.||||0.065
70873967|NCT02692703|141232409|NON_INFERIORITY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment as compared with the historical rate for the current standard of care regimens (SOF/LDV + RBV or SOF + DCV + RBV) was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 86% to achieve noninferiority.|Percentage of Participants|98.0|||||TWO_SIDED|95.0|95.3|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of ≥96%, 90 participants provides \>90% power to demonstrate noninferiority of the regimen to the historical rate for current standard of care regimens (SOF/LDV + RBV OR SOF + DCV + RBV) (94%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|95.3|
70954984|NCT00611975|141413184|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.7|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||>0.7
70954985|NCT00611975|141413184|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||<.0001
71146141|NCT00385671|141785571|SUPERIORITY_OR_OTHER|||||||0.622||95.0||||P-value is for high. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of patients with treatment-emergent high body weight.||||0.622
71146142|NCT00385671|141785571|SUPERIORITY_OR_OTHER|||||||0.103||95.0||||P-value is for low. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of patients with treatment-emergent low body weight.||||0.103
71146143|NCT00385671|141785571|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||P-value is for low. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of patients with treatment-emergent low body weight.||||0.034
71146144|NCT00385671|141785571|SUPERIORITY_OR_OTHER|||||||0.808||95.0||||P-value is for low. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of patients with treatment-emergent low body weight.||||0.808
70954986|NCT00611975|141413185|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.9|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||>0.9
70954987|NCT00611975|141413185|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||<.0001
70954988|NCT00611975|141413186|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.9|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||>0.9
70954989|NCT00611975|141413186|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.9|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||>0.9
70954990|NCT00611975|141413187|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.1|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||>0.1
70954991|NCT00611975|141413187|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.7|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||>0.7
70954992|NCT03333876|141413206|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Each group was compared to baseline.||||<.001
70954993|NCT00095498|141413211|SUPERIORITY_OR_OTHER_LEGACY|||||||0.264|||||||van Elteren stratified rank test|||||||0.264
70954994|NCT00095498|141413211|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||van Elteren stratified rank test|||||||0.018
71146145|NCT00385671|141785572|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in AST.||||0.055
70954995|NCT00095498|141413212|SUPERIORITY_OR_OTHER_LEGACY|||||||0.032|||||||van Elteren Stratified Rank Test|||||||0.032
70954996|NCT00095498|141413212|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|||||||van Elteren Stratified Rank Test|||||||0.180
70954997|NCT00095498|141413213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.602|||||||van Elteren Stratified Rank Test|||||||0.602
70954998|NCT00095498|141413213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.181|||||||van Elteren Stratified Rank Test|||||||0.181
70954999|NCT00095498|141413214|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|||||||van Elteren Stratified Rank Test|||||||0.012
70955000|NCT00095498|141413214|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||van Elteren Stratified Rank Test|||||||0.007
70955001|NCT00095498|141413215|SUPERIORITY_OR_OTHER_LEGACY|||||||0.277|||||||van Elteren Stratified Rank Test|||||||0.277
70955002|NCT00095498|141413215|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019|||||||van Elteren Stratified Rank Test|||||||0.019
70955003|NCT00095498|141413216|SUPERIORITY_OR_OTHER_LEGACY|||||||0.382|||||||van Elteren Stratified Rank Test|||||||0.382
70955004|NCT00095498|141413216|SUPERIORITY_OR_OTHER_LEGACY|||||||0.488|||||||van Elteren Stratified Rank Test|||||||0.488
70955005|NCT00095498|141413217|SUPERIORITY_OR_OTHER_LEGACY|||||||0.236|||||||van Elteren Stratified Rank Test|||||||0.236
70955006|NCT00095498|141413217|SUPERIORITY_OR_OTHER_LEGACY|||||||0.712|||||||van Elteren Stratified Rank Test|||||||0.712
70955007|NCT00095498|141413218|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.93||||0.026||95.0|0.11|1.74|||Repeated Measures Model|||||1.74|0.11|0.026
70955008|NCT00095498|141413218|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.59||||0.155||95.0|-0.23|1.41|||Repeated measures model|||||1.41|-0.23|0.155
70955009|NCT00095498|141413219|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.67||||0.002||95.0|0.62|2.72|||Repeated Measures Model|||||2.72|0.62|0.002
70955010|NCT00095498|141413219|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.89|||<|0.001||95.0|0.84|2.94|||Repeated Measures Model|||||2.94|0.84|<0.001
70955011|NCT00095498|141413220|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.2|||<|0.001||95.0|1.1|3.29|||Repeated Measures Model|||||3.29|1.1|<0.001
70955012|NCT00095498|141413220|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.29|||<|0.001||95.0|2.18|4.39|||Repeated Measures Model|||||4.39|2.18|<0.001
70955013|NCT00095498|141413221|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01||||0.986||95.0|-1.06|1.08|||Repeated Measures Model|||||1.08|-1.06|0.986
70955014|NCT00095498|141413221|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8||||0.141||95.0|-0.27|1.86|||Repeated Measures Model|||||1.86|-0.27|0.141
70955015|NCT00095498|141413222|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.95||||0.073||95.0|-0.09|1.99|||Repeated Measures Model|||||1.99|-0.09|0.073
70955016|NCT00095498|141413222|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.89||||0.09||95.0|-0.14|1.93|||Repeated Measures Model|||||1.93|-0.14|0.09
70873968|NCT02442869|141232420|SUPERIORITY||Net difference in proportion|1.73||||0.19|TWO_SIDED|95.0|-2.41|15.35|||Chi-squared|Df (1)|NNT = 5.59|Due to the large number of zeroes in the Suicidal Ideation (SI)-Current Subscale of the SSI at post (over a third of the participants reported no SI at the end of treatment), a zero-altered model was utilized which divided the outcome into (1) the probability of any SI and (2) the intensity of SI when non-zero, as done in other studies. This analysis tested the difference between the CAMS and TAU arms based on number of participants reporting no SI post Stage 1 treatment.||15.35|-2.41|0.19
70873969|NCT02442869|141232421|SUPERIORITY||Net difference in proportion|1.3||||0.25|TWO_SIDED||||||Regression, Logistic|||||||0.25
70873970|NCT02442869|141232422|SUPERIORITY|Power analyses. We determined that with a sample size of 62 clients, the outcome analyses had at least 80% power to detect an effect size of 0.80 (Ahn etal., 2001)|Mean Difference (Net)|0.55||||0.035|TWO_SIDED|95.0|0.04|1.05|||t-test, 2 sided|t(60) = 2.15||||1.05|0.04|0.035
70955017|NCT00095498|141413223|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.81||||0.007||95.0|0.51|3.12|||Repeated Measures Model|||||3.12|0.51|0.007
70955018|NCT00095498|141413223|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.98||||0.003||95.0|0.67|3.29|||Repeated Measures Model|||||3.29|0.67|0.003
70955019|NCT00095498|141413224|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.938||95.0|-0.58|0.63|||Repeated Measures Model|||||0.63|-0.58|0.938
70955020|NCT00095498|141413224|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08||||0.787||95.0|-0.53|0.69|||Repeated Measures Model|||||0.69|-0.53|0.787
71146146|NCT00385671|141785572|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in AST.||||0.051
71146147|NCT00385671|141785572|SUPERIORITY_OR_OTHER|||||||0.993||95.0||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in AST.||||0.993
71146148|NCT00385671|141785572|SUPERIORITY_OR_OTHER|||||||0.928||95.0||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in ALT.||||0.928
71146149|NCT00385671|141785572|SUPERIORITY_OR_OTHER|||||||0.609||95.0||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in ALT.||||0.609
71146150|NCT00385671|141785572|SUPERIORITY_OR_OTHER|||||||0.675||95.0||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 in ALT.||||0.675
71146151|NCT00385671|141785572|SUPERIORITY_OR_OTHER|||||||0.985||95.0||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in GGT.||||0.985
71146152|NCT00385671|141785572|SUPERIORITY_OR_OTHER|||||||0.847||95.0||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in GGT.||||0.847
71146153|NCT00385671|141785572|SUPERIORITY_OR_OTHER|||||||0.832||95.0||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 in GGT.||||0.832
71146154|NCT00385671|141785572|SUPERIORITY_OR_OTHER|||||||0.169||95.0||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in AlkPhos.||||0.169
71146155|NCT00385671|141785572|SUPERIORITY_OR_OTHER|||||||0.91||95.0||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in AlkPhos.||||0.910
70873971|NCT05048784|141232423|OTHER|Statistical analysis was conducted to investigate the bioequivalence of treatment A (test 1) to treatment B (reference) for Cmax.|Ratio of geometric least squares means|1.009|||||TWO_SIDED|90.0|0.98|1.04|||||The geometric least squares mean ratios and confidence intervals (Cls) were obtained by taking the exponential of the corresponding differences and Cls on the natural-log (In) scale.|||1.040|0.980|
70955021|NCT00095498|141413225|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.004||95.0|0.33|1.67|||Repeated Measures Model|||||1.67|0.33|0.004
70955022|NCT00095498|141413225|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.18|||<|0.001||95.0|0.51|1.85|||Repeated Measures Model|||||1.85|0.51|<0.001
71146156|NCT00385671|141785572|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 in AlkPhos.||||0.134
70873972|NCT05048784|141232424|OTHER|Statistical analysis was conducted to investigate the bioequivalence of treatment A (test 1) to treatment B (reference) for AUClast.|Ratio of geometric least squares means|1.01|||||TWO_SIDED|90.0|0.967|1.055|||||The geometric least squares mean ratios and Cls were obtained by taking the exponential of the corresponding differences and Cls on the In scale.|||1.055|0.967|
70955023|NCT00095498|141413226|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.94|||<|0.001||95.0|1.02|2.85|||Repeated Measures Model|||||2.85|1.02|<0.001
70955024|NCT00095498|141413226|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.04|||<|0.001||95.0|1.13|2.96|||Repeated Measures Model|||||2.96|1.13|<0.001
70955025|NCT00095498|141413227|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
70955026|NCT00095498|141413227|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
70955027|NCT00095498|141413228|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
70955028|NCT00095498|141413228|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
70955029|NCT00095498|141413229|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
70955030|NCT00095498|141413229|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
70955031|NCT00095498|141413230|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
70955032|NCT00095498|141413230|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
70955033|NCT00095498|141413231|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
70955034|NCT00095498|141413231|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
70955035|NCT00095498|141413232|SUPERIORITY_OR_OTHER_LEGACY|||||||0.016|||||||van Elteren Stratified Rank Test|||||||0.016
70955036|NCT00095498|141413232|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
70955037|NCT00095498|141413233|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
70955038|NCT00095498|141413233|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
70955039|NCT00095498|141413234|SUPERIORITY_OR_OTHER_LEGACY|||||||0.673|||||||van Elteren Stratified Rank Test|||||||0.673
70955040|NCT00095498|141413234|SUPERIORITY_OR_OTHER_LEGACY|||||||0.589|||||||van Elteren Stratified Rank Test|||||||0.589
70955041|NCT00095498|141413235|SUPERIORITY_OR_OTHER_LEGACY|||||||0.175|||||||van Elteren Stratified Rank Test|||||||0.175
70873973|NCT05048784|141232425|OTHER|Statistical analysis was conducted to investigate the bioequivalence of treatment A (test 1) to treatment B (reference) for AUCinf.|Ratio of geometric least squares means|1.02|||||TWO_SIDED|90.0|0.977|1.065|||||The geometric least squares mean ratios and Cls were obtained by taking the exponential of the corresponding differences and Cls on the In scale.|||1.065|0.977|
70955042|NCT00095498|141413235|SUPERIORITY_OR_OTHER_LEGACY|||||||0.133|||||||van Elteren Stratified Rank Test|||||||0.133
70955043|NCT03439254|141413368|OTHER||Response ratio(Mantel-Haenszel estimate)|1.13||||0.6172|TWO_SIDED|95.0|0.71|1.79|||Cochran-Mantel-Haenszel||Treatment / Placebo Response Ratio = Percentage of Responders in Active Treatment Arm / Percentage of Responders in Placebo, stratified by Baseline diabetes status (yes/no).|||1.79|0.71|0.6172
70955044|NCT03439254|141413368|OTHER||Response ratio(Mantel-Haenszel estimate)|1.2||||0.4184|TWO_SIDED|95.0|0.77|1.89|||Cochran-Mantel-Haenszel||Treatment / Placebo Response Ratio = Percentage of Responders in Active Treatment Arm / Percentage of Responders in Placebo, stratified by Baseline diabetes status (yes/no).|||1.89|0.77|0.4184
70955045|NCT02075476|141413382|EQUIVALENCE|Normality in sample distribution was tested using the Kolmororov-Smirnov test and graphic models. For descriptive variables we use Pearson's Chi-square, and for the study of numerical variables over time we use a mixed linear test.||||||0.048|||||||Mixed Models Analysis|||||||0.048
70955046|NCT02075476|141413383|EQUIVALENCE|Normality in sample distribution was tested using the Kolmororov-Smirnov test and graphic models. For descriptive variables we use Pearson's Chi-square, and for the study of numerical variables over time we use a mixed linear test.||||||0.001|||||||Mixed Models Analysis|||||||0.001
70955047|NCT02075476|141413384|EQUIVALENCE|Normality in sample distribution was tested using the Kolmororov-Smirnov test and graphic models. For descriptive variables we use Pearson's Chi-square, and for the study of numerical variables over time we use a mixed linear test.||||||0.011|||||||Mixed Models Analysis|||||||0.011
71146157|NCT00385671|141785573|SUPERIORITY_OR_OTHER|||||||0.285||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 total bilirubin.||||0.285
70955048|NCT00923260|141413398|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||t-test, 2 sided|||||||0.79
70955049|NCT00923260|141413399|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||t-test, 2 sided|||||||0.49
70955050|NCT00923260|141413400|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||t-test, 2 sided|||||||0.96
70955051|NCT00923260|141413401|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||t-test, 2 sided|||||||.86
70955052|NCT00923260|141413402|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||t-test, 2 sided|||||||0.60
70955053|NCT00923260|141413403|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||t-test, 2 sided|||||||0.76
70955054|NCT00923260|141413404|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||t-test, 2 sided|||||||0.45
70955055|NCT00923260|141413405|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||t-test, 2 sided|||||||0.81
70955056|NCT00923260|141413406|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||t-test, 2 sided|||||||0.92
70955057|NCT00923260|141413407|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||||||0.01
70955058|NCT00923260|141413408|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||t-test, 2 sided|||||||0.15
70955059|NCT00923260|141413409|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||t-test, 2 sided|||||||0.20
70955060|NCT00923260|141413410|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||t-test, 2 sided|||||||0.64
70955061|NCT00923260|141413411|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||t-test, 2 sided|||||||0.92
70955062|NCT00923260|141413412|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
70955063|NCT00923260|141413413|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||t-test, 2 sided|||||||0.21
70955064|NCT00923260|141413414|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||t-test, 2 sided|||||||0.65
70955065|NCT00923260|141413415|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||t-test, 2 sided|||||||0.33
70955066|NCT00923260|141413416|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||t-test, 2 sided|||||||0.39
70955067|NCT00923260|141413417|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||t-test, 2 sided|||||||0.47
70955068|NCT00923260|141413418|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||t-test, 2 sided|||||||0.75
70955069|NCT00923260|141413419|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||t-test, 2 sided|||||||0.94
70955070|NCT00923260|141413420|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||t-test, 2 sided|||||||0.74
70955071|NCT00923260|141413421|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||t-test, 2 sided|||||||0.72
70955072|NCT00923260|141413422|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||t-test, 2 sided|||||||0.67
70955073|NCT00923260|141413423|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||t-test, 2 sided|||||||0.64
70955074|NCT00923260|141413424|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||t-test, 2 sided|||||||0.038
70955075|NCT00923260|141413425|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||t-test, 2 sided|||||||0.14
70955076|NCT00923260|141413426|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||t-test, 2 sided|||||||0.21
70955077|NCT00923260|141413427|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||t-test, 2 sided|||||||0.42
70955078|NCT00923260|141413428|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||t-test, 2 sided|||||||0.18
70955079|NCT00923260|141413429|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||t-test, 2 sided|||||||0.10
70955080|NCT00923260|141413430|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||t-test, 2 sided|||||||0.16
70955081|NCT00923260|141413431|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||t-test, 2 sided|||||||0.18
71146158|NCT00385671|141785573|SUPERIORITY_OR_OTHER|||||||0.505||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in total bilirubin.||||0.505
71146159|NCT00385671|141785573|SUPERIORITY_OR_OTHER|||||||0.679||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in total bilirubin.||||0.679
71146160|NCT00385671|141785574|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in fasting blood glucose.||||0.047
71146161|NCT00385671|141785574|SUPERIORITY_OR_OTHER|||||||0.232||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in fasting blood glucose.||||0.232
71146162|NCT00385671|141785574|SUPERIORITY_OR_OTHER|||||||0.424||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in fasting blood glucose.||||0.424
71146163|NCT00385671|141785575|SUPERIORITY_OR_OTHER|||||||0.298||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in hemoglobin A1C.||||0.298
71146164|NCT00385671|141785575|SUPERIORITY_OR_OTHER|||||||0.987||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in hemoglobin A1C.||||0.987
71146165|NCT00385671|141785575|SUPERIORITY_OR_OTHER|||||||0.297||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in hemoglobin A1C.||||0.297
71146166|NCT00385671|141785576|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated AST values.||||1.00
71146167|NCT00385671|141785576|SUPERIORITY_OR_OTHER|||||||0.749||95.0||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated AST values.||||0.749
71146168|NCT00385671|141785576|SUPERIORITY_OR_OTHER|||||||0.75||95.0||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated AST values.||||0.750
70955082|NCT00923260|141413432|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||t-test, 2 sided|||||||0.40
70955083|NCT00923260|141413433|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||t-test, 2 sided|||||||0.44
70955084|NCT00923260|141413434|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||t-test, 2 sided|||||||0.035
70955085|NCT00923260|141413435|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||t-test, 2 sided|||||||0.07
70955086|NCT00923260|141413436|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||t-test, 2 sided|||||||0.99
70955087|NCT00923260|141413437|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||t-test, 2 sided|||||||0.96
70955088|NCT00923260|141413438|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||t-test, 2 sided|||||||0.44
70955089|NCT00923260|141413439|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||t-test, 2 sided|||||||0.97
70955090|NCT00923260|141413440|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||t-test, 2 sided|||||||0.85
70955091|NCT00923260|141413441|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||t-test, 2 sided|||||||0.61
70873974|NCT05048784|141232427|OTHER|Statistical analysis was conducted to investigate the food effect of treatment C (test 2) to treatment A (test 1) for Cmax.|Ratio of geometric least squares means|1.001|||||TWO_SIDED|90.0|0.836|1.199|||||The geometric least squares mean ratios and Cls were obtained by taking the exponential of the corresponding differences and Cls on the In scale.|||1.199|0.836|
70873975|NCT05048784|141232428|OTHER|Statistical analysis was conducted to investigate the food effect of treatment C (test 2) to treatment A (test 1) for AUClast.|Ratio of geometric least squares means|1.447|||||TWO_SIDED|90.0|1.2|1.745|||||The geometric least squares mean ratios and Cls were obtained by taking the exponential of the corresponding differences and Cls on the In scale.|||1.745|1.200|
70873976|NCT05048784|141232429|OTHER|Statistical analysis was conducted to investigate the food effect of treatment C (test 2) to treatment A (test 1) for AUCinf.|Ratio of geometric least squares means|1.484|||||TWO_SIDED|90.0|1.236|1.783|||||The geometric least squares mean ratios and Cls were obtained by taking the exponential of the corresponding differences and Cls on the In scale.|||1.783|1.236|
70873977|NCT01425281|141232498|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|"Null and alternative hypotheses for superiority testing.~H0: EndpointABSORB BVS = EndpointXIENCE H1: EndpointABSORB BVS ≠ EndpointXIENCE"||Angiographic vasomotion reactivity following nitrate administration, the test was analyzable for 388 paired lesions (Absorb arm \[258 lesions\] vs Xience arm \[130 lesions\]).||||0.49
70873978|NCT01425281|141232499|NON_INFERIORITY|Using t-test with non-inferiority margin of 0.140mm||||||0.78|||||||t-test, 2 sided|"Null and alternative hypotheses for superiority testing.~H0: EndpointABSORB BVS = EndpointXIENCE H1: EndpointABSORB BVS ≠ EndpointXIENCE"||Follow-up angiographic analysis was available for 298 lesions in the Absorb arm and 151 lesions in the Xience arm.||||0.78
70873979|NCT01979016|141232641|SUPERIORITY||Least Squares (LS) Mean Difference|-69.4|||<|0.0001|TWO_SIDED|95.0|-92.5|-46.2|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a mixed model repeated measures (MMRM) model.||-46.2|-92.5|< 0.0001
70873980|NCT01979016|141232642|SUPERIORITY||Percentage difference|37.0|||=|0.0006|TWO_SIDED|95.0|18.82|55.25|||Cochran-Mantel-Haenszel||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.||55.25|18.82|= 0.0006
70873981|NCT01979016|141232643|SUPERIORITY||Percentage difference|48.1|||<|0.0001|TWO_SIDED|95.0|28.0|68.3|||Cochran-Mantel-Haenszel||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.||68.30|28.00|< 0.0001
70873982|NCT01979016|141232644|SUPERIORITY||LS Mean Difference|-2.66|||<|0.0001|TWO_SIDED|95.0|-3.8|-1.52|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.||-1.52|-3.80|< 0.0001
70873983|NCT01979016|141232645|SUPERIORITY||LS Mean Difference|-48.08|||=|0.0001|TWO_SIDED|95.0|-71.31|-24.85|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.||-24.85|-71.31|= 0.0001
70873984|NCT01979016|141232646|SUPERIORITY||LS Mean Difference|-21.5|||<|0.0001|TWO_SIDED|95.0|-29.0|-14.0|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.||-14.0|-29.0|<0.0001
70873985|NCT01979016|141232647|SUPERIORITY||LS Mean Difference|-31.3|||<|0.0001|TWO_SIDED|95.0|-41.5|-21.1|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.||-21.1|-41.5|< 0.0001
70873986|NCT01979016|141232648|SUPERIORITY||LS Mean Difference|-46.6|||<|0.0001|TWO_SIDED|95.0|-62.0|-31.3|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by MMRM model.||-31.3|-62.0|< 0.0001
70873987|NCT01979016|141232649|SUPERIORITY||Percentage difference|55.6|||<|0.0001|TWO_SIDED|95.0|33.38|77.73|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 50% reduction from baseline in EASI score (EASI-50). Analysis was performed by a MMRM model.||77.73|33.38|< 0.0001
70873988|NCT01979016|141232649|SUPERIORITY||Percentage difference|51.9|||=|0.0001|TWO_SIDED|95.0|29.59|74.12|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 75% reduction from baseline in EASI score (EASI-75). Analysis was performed by a MMRM model.||74.12|29.59|= 0.0001
70873989|NCT01979016|141232649|SUPERIORITY||Percentage difference|33.3|||=|0.0011|TWO_SIDED|95.0|15.55|51.11|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 90% reduction from baseline in EASI score (EASI-90). Analysis was performed by a MMRM model.||51.11|15.55|= 0.0011
70873990|NCT01979016|141232650|SUPERIORITY||Percentage difference|48.1|||=|0.0002|TWO_SIDED|95.0|27.0|69.3|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 50% reduction from baseline in SCORAD Score (SCORAD-50). Analysis was performed by a MMRM model.||69.3|27.0|= 0.0002
70873991|NCT01979016|141232650|SUPERIORITY||Percentage difference|11.1|||=|0.0792|TWO_SIDED|95.0|-0.7|23.0|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 75% reduction from baseline in SCORAD Score (SCORAD-75). Analysis was performed by a MMRM model.||23.0|-0.7|= 0.0792
70873992|NCT01979016|141232650|SUPERIORITY||Percentage difference|7.4|||=|0.1573|TWO_SIDED|95.0|-2.5|17.3|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 90% reduction from baseline in SCORAD Score (SCORAD-90). Analysis was performed by a MMRM model.||17.3|-2.5|= 0.1573
70873993|NCT01979016|141232651|SUPERIORITY||LS Mean Difference|-10.4|||<|0.0001|TWO_SIDED|95.0|-14.3|-6.6|||ANCOVA|||Analysis was performed by a MMRM model.||-6.6|-14.3|< 0.0001
70873994|NCT01979016|141232652|SUPERIORITY||LS Mean Difference|-46.2|||<|0.0001|TWO_SIDED|95.0|-63.9|-28.5|||ANCOVA|||Analysis was performed by a MMRM model.||-28.5|-63.9|< 0.0001
70873995|NCT01979016|141232654|SUPERIORITY||LS Mean Difference|-3.7|||<|0.0001|TWO_SIDED|95.0|-5.02|-2.39|||ANCOVA|||||-2.39|-5.02|< 0.0001
70873996|NCT02509156|141232738|SUPERIORITY||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|2.57||0.746|TWO_SIDED|95.0|-4.52|6.11|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||6.11|-4.52|0.746
70873997|NCT02509156|141232739|SUPERIORITY||slope of time|1.53|STANDARD_ERROR_OF_MEAN|0.63||0.024|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.024
70873998|NCT02509156|141232740|SUPERIORITY||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.94||0.328|TWO_SIDED|95.0|-2.68|1.26|||ANCOVA||Confidence intervals based on t-test|The change in global strain was compared using ANCOVA analyses adjusting for baseline values.||1.26|-2.68|0.328
70955092|NCT00923260|141413442|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||t-test, 2 sided|||||||0.55
70955093|NCT00923260|141413443|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||t-test, 2 sided|||||||0.65
70955094|NCT00923260|141413444|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||t-test, 2 sided|||||||0.74
70955095|NCT00923260|141413445|SUPERIORITY_OR_OTHER|||||||0.57||95.0|||||t-test, 2 sided|||||||0.57
70955096|NCT00923260|141413446|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||t-test, 2 sided|||||||0.87
70955097|NCT00923260|141413447|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||t-test, 2 sided|||||||0.28
70955098|NCT00923260|141413448|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||t-test, 2 sided|||||||0.64
70955099|NCT00923260|141413449|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||t-test, 2 sided|||||||0.42
70955100|NCT00923260|141413450|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||t-test, 2 sided|||||||0.72
70955101|NCT00923260|141413451|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||t-test, 2 sided|||||||0.68
71146169|NCT00385671|141785576|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated ALT values.||||0.050
70955102|NCT00923260|141413452|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||t-test, 2 sided|||||||0.08
70955103|NCT00923260|141413453|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||t-test, 2 sided|||||||0.71
70955104|NCT00923260|141413454|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||t-test, 2 sided|||||||0.32
70955105|NCT00923260|141413455|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||t-test, 2 sided|||||||0.64
70955106|NCT00923260|141413456|SUPERIORITY_OR_OTHER|||||||0.52||95.0|||||t-test, 2 sided|||||||0.52
70955107|NCT00923260|141413457|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||t-test, 2 sided|||||||0.59
70955108|NCT00923260|141413458|SUPERIORITY_OR_OTHER|||||||0.57||95.0|||||t-test, 2 sided|||||||0.57
70955109|NCT00923260|141413459|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||t-test, 2 sided|||||||0.43
70955110|NCT00923260|141413460|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||t-test, 2 sided|||||||0.72
70955111|NCT00923260|141413461|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||t-test, 2 sided|||||||0.56
70955112|NCT00660543|141413462|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 1 sided|Differences between groups were assessed by using the Student paired t test and were graphed by using Bland-Altman plots.||||||.003
70955113|NCT00660543|141413462|SUPERIORITY_OR_OTHER|||||||0.008|||||||t-test, 1 sided|Differences between groups were assessed by using the Student paired t test and were graphed by using Bland-Altman plots.||||||.008
70955114|NCT03829475|141413464|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
70955115|NCT00943852|141413547|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||1-sided, alpha = 0.05|ANOVA|Fixed effects model with terms for subject, treatment and period||||||<0.001
70955116|NCT00943852|141413548|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||1-sided, alpha = 0.05|ANOVA|Fixed effects model with terms for subject, treatment and period||||||<0.001
70955117|NCT03651622|141413576|SUPERIORITY|||||||0.98|||||||ANOVA|||||||0.98
70955118|NCT03651622|141413577|SUPERIORITY|||||||0.85|||||||ANOVA|||||||0.85
70955119|NCT03651622|141413578|SUPERIORITY|||||||0.4|||||||ANOVA|||||||0.40
70955120|NCT03651622|141413579|SUPERIORITY|||||||0.02|||||||ANOVA|||||||0.02
70955121|NCT03651622|141413580|SUPERIORITY|||||||0.38|||||||ANOVA|||||||0.38
70955122|NCT03651622|141413581|SUPERIORITY|||||||0.18|||||||ANOVA|||||||0.18
70955123|NCT03651622|141413582|SUPERIORITY|||||||0.79|||||||ANOVA|||||||0.79
70955124|NCT03651622|141413583|SUPERIORITY|||||||0.39|||||||ANOVA|||The proposed sample size of n=72 was sufficient to ensure 60% power to detect a moderate effect size (Cohen h=0.68) and 80% to detect a large effect size (Cohen h=0.85) at a significance level of 0.10 for comparing difference in change among the 3 diets. By design, our primary goal for this pilot work is to inform the final efficacy design of a fully powered SMART, and the pilot SMART was therefore not designed to be fully powered for all analyses.||||0.39
70955125|NCT03651622|141413584|SUPERIORITY|||||||0.75|||||||ANOVA|||||||0.75
70955126|NCT03651622|141413585|SUPERIORITY|||||||0.66|||||||ANOVA|||||||0.66
70955127|NCT03651622|141413586|SUPERIORITY|||||||0.96|||||||ANOVA|||||||0.96
70955128|NCT03651622|141413587|SUPERIORITY|||||||0.34|||||||ANOVA|||||||0.34
70955129|NCT03651622|141413588|SUPERIORITY|||||||0.58|||||||ANOVA|||||||0.58
70955130|NCT03651622|141413589|SUPERIORITY|||||||0.95|||||||ANOVA|||||||0.95
70955131|NCT03651622|141413590|SUPERIORITY|||||||0.08|||||||ANOVA|||||||0.08
71146170|NCT00385671|141785576|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated ALT values.||||0.320
71146171|NCT00385671|141785576|SUPERIORITY_OR_OTHER|||||||0.44||95.0||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated ALT values.||||0.440
70873999|NCT02509156|141232741|SUPERIORITY||slope of time|-0.26|STANDARD_ERROR_OF_MEAN|0.23||0.261|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope"|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.261
71146172|NCT00385671|141785576|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||P-value is for TBili. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated TBili values.||||0.498
71146173|NCT00385671|141785576|SUPERIORITY_OR_OTHER|||||||0.245||95.0||||P-value is for TBili. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated TBili values.||||0.245
71146174|NCT00385671|141785576|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated GGT values.||||0.160
71146175|NCT00385671|141785576|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated GGT values.||||0.280
71146176|NCT00385671|141785576|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated GGT values.||||1.00
71146177|NCT00385671|141785576|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value is for FPG. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated FPG values.||||0.023
71146178|NCT00385671|141785576|SUPERIORITY_OR_OTHER|||||||0.264||95.0||||P-value is for FPG. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated FPG values.||||0.264
71146179|NCT00385671|141785576|SUPERIORITY_OR_OTHER|||||||0.325||95.0||||P-value is for FPG. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated FPG values.||||0.325
71146180|NCT00385671|141785576|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for HbA1C. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated HbA1C values.||||1.00
71146181|NCT00385671|141785576|SUPERIORITY_OR_OTHER|||||||0.121||95.0||||P-value is for HbA1C. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated HbA1C values.||||0.121
71146182|NCT00385671|141785576|SUPERIORITY_OR_OTHER|||||||0.095||95.0||||P-value is for HbA1C. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated HbA1C values.||||0.095
71146183|NCT00385671|141785576|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated AlkPhos values.||||1.00
71146184|NCT00385671|141785576|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated AlkPhos values.||||0.720
70874000|NCT02509156|141232742|SUPERIORITY||Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|1.41||0.071|TWO_SIDED|95.0|-4.51|1.35|||ANCOVA||Confidence intervals based on t-test|The change in regional strain was compared using ANCOVA analyses adjusting for baseline values.||1.35|-4.51|0.071
70874001|NCT02509156|141232743|SUPERIORITY||slope of time|-0.14|STANDARD_ERROR_OF_MEAN|0.35||0.689|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope"|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.689
70874002|NCT02509156|141232744|SUPERIORITY||Mean Difference (Final Values)|1.06|STANDARD_ERROR_OF_MEAN|6.46||0.935|TWO_SIDED|95.0|-12.33|14.45|||ANCOVA||Confidence intervals based on t-test|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.||14.45|-12.33|0.935
70874003|NCT02509156|141232745|SUPERIORITY||slope of time|-1.56|STANDARD_ERROR_OF_MEAN|1.55||0.325|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope"|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.325
70874004|NCT02509156|141232746|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|5.99||0.919|TWO_SIDED|95.0|-11.75|13.08|||ANCOVA||Confidence intervals based on t-test|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.||13.08|-11.75|0.919
70874005|NCT02509156|141232747|SUPERIORITY||slope of time|-1.99|STANDARD_ERROR_OF_MEAN|1.45||0.183|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.183
71146185|NCT00385671|141785576|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated AlkPhos values.||||0.722
71146186|NCT04944992|141785577|SUPERIORITY||Difference in least squared means|30.4|||<|0.0001|TWO_SIDED|90.0|22.1|38.7|||Mixed Models Analysis|||||38.7|22.1|<0.0001
70874006|NCT02509156|141232748|SUPERIORITY||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.035||0.124|TWO_SIDED|95.0|0.003|0.15|||ANCOVA||Confidence intervals based on t-test|The change in LV sphericity index was compared using ANCOVA analyses adjusting for baseline values.||0.15|0.003|0.124
70874007|NCT02509156|141232749|SUPERIORITY|||||||||||||||||Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. A time by treatment interaction was assessed.|There was a significant treatment and time interaction (p=0.024), so we report a slope for each treatment arm.|||
71146187|NCT04944992|141785578|OTHER|Difference (Efinopegdutide - Semaglutide) in %|difference in percentage|16.3||||||95.0|3.5|29.1||||||||29.1|3.5|
71146188|NCT04944992|141785579|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in percentage|5.6||||||95.0|0.4|13.5||||||||13.5|0.4|
71146189|NCT04944992|141785580|SUPERIORITY||Difference in least squared means|6.1|||<|0.001|TWO_SIDED|90.0|4.6|7.7|||Mixed Models Analysis|||||7.7|4.6|<0.001
71146190|NCT04944992|141785581|SUPERIORITY||Difference in Least Squared Means|-1.4||||0.085|TWO_SIDED|90.0|-2.7|-0.1|||Mixed Models Analysis|||||-0.1|-2.7|0.085
71146191|NCT04944992|141785582|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in Least Squared Means|-7.2|||||TWO_SIDED|90.0|-11.2|-3.1||||||||-3.1|-11.2|
71146192|NCT04944992|141785583|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in least squared means|-5.7||||||90.0|-10.9|-0.6||||||||-0.6|-10.9|
71146193|NCT04944992|141785584|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in least squared means|-11.7||||||90.0|-15.8|-7.7||||||||-7.7|-15.8|
71146194|NCT04944992|141785585|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in least squared means|-6.1||||||90.0|-12.0|-0.1||||||||-0.1|-12.0|
71146195|NCT04944992|141785586|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in least squared means|-7.6|||||TWO_SIDED|90.0|-14.3|-0.9||||||||-0.9|-14.3|
71146196|NCT04944992|141785587|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in least squared means|-5.4|||||TWO_SIDED|90.0|-10.4|-0.4||||||||-0.4|-10.4|
71146197|NCT01295814|141785588|NON_INFERIORITY_OR_EQUIVALENCE|"The study had acceptable sensitivity with a statistical power of 0.99 (99%) for the improvement in the adalimumab group from baseline to week 12.~The study had acceptable sensitivity with a statistical power of 0.92 (92%) for the improvement in the placebo group from baseline to week 12."|Mean Difference (Final Values)|7.9||||0.75|TWO_SIDED|95.0|4.0|11.8||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|t-test, 2 sided||Confidence interval was improvement in OSPI in the adalimumab group from baseline to week 12.|Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.||11.8|4.0|0.75
71146198|NCT01295814|141785589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0||||0.99|TWO_SIDED|95.0|1.7|6.3||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|t-test, 2 sided||Confidence interval was improvement in ICSI in the adalimumab group from baseline to week 12.|Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.||6.3|1.7|0.99
71146199|NCT01295814|141785590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9||||0.76|TWO_SIDED|95.0|2.1|5.8||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|t-test, 2 sided||Confidence interval was improvement in ICPI in the adalimumab group from baseline to week 12.|Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.||5.8|2.1|0.76
71146200|NCT01295814|141785591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3||||0.76|TWO_SIDED|95.0|2.6|10.0||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|t-test, 2 sided||Confidence interval was improvement in PUF in the adalimumab group from baseline to week 12.|Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.||10.0|2.6|0.76
71146201|NCT01295814|141785592|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|t-test, 2 sided|||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.||||0.67
71146202|NCT03414983|141785593|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.3022|TWO_SIDED|80.0|0.61|1.07||Stratified regular log-rank test|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: NIV+mFOLFOX+BEV over Arm B: mFOLFOX+BEV||1.07|0.61|0.3022
71146203|NCT03414983|141785593|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.3022|TWO_SIDED|95.0|0.53|1.23||Stratified regular log-rank test|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: NIV+mFOLFOX+BEV over Arm B: mFOLFOX+BEV||1.23|0.53|0.3022
71146204|NCT03414983|141785594|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.54|1.19|||||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: NIV+mFOLFOX+BEV over Arm B: mFOLFOX+BEV||1.19|0.54|
71146205|NCT03414983|141785609|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.5041|TWO_SIDED|80.0|0.67|1.15||Stratified regular log-rank test|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: NIV+mFOLFOX+BEV over Arm B: mFOLFOX+BEV||1.15|0.67|0.5041
71146206|NCT03414983|141785609|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.5041|TWO_SIDED|95.0|0.58|1.32||Stratified regular log-rank test|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: NIV+mFOLFOX+BEV over Arm B: mFOLFOX+BEV||1.32|0.58|0.5041
71146207|NCT02364700|141785645|EQUIVALENCE|Group means from baseline to discharge were compared to determine if 6-week and training on the Hand of Hope device elicited changes in outcome measures.|||||<|0.05|||||||Friedman Test|||||||<.05
71146208|NCT00804908|141785651|SUPERIORITY_OR_OTHER||||||=|0.071|||||||Stratified log-rank|||Comparisons between treatment groups were performed using a Comparisons between treatment groups were performed using a log-rank test stratified by baseline lactate dehydrogenase (LDH) status (0 to 1 ULN; \>1 to ≤ 2 ULN) and history of previously treated brain metastases (with, without). Hochberg testing procedure for multiplicity adjustment.||||=0.071
71146209|NCT00804908|141785651|SUPERIORITY_OR_OTHER||||||=|0.233|||||||Stratified log-rank|||Comparisons between treatment groups were performed using a Comparisons between treatment groups were performed using a log-rank test stratified by baseline lactate dehydrogenase (LDH) status (0 to 1 ULN; \>1 to ≤ 2 ULN) and history of previously treated brain metastases (with, without). Hochberg testing procedure for multiplicity adjustment.||||=0.233
71146210|NCT01280903|141785659|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
71146211|NCT01280903|141785660|SUPERIORITY|||||||0.13||||||p=0.130 for None to very low|Mixed Models Analysis|||||||0.130
71146212|NCT01280903|141785660|SUPERIORITY|||||||0.573||||||p=0.573 for Light|Mixed Models Analysis|||||||0.573
71146213|NCT01280903|141785660|SUPERIORITY|||||||0.197||||||p=0.197 for Moderate-to-vigorous|Mixed Models Analysis|||||||0.197
71146214|NCT01280903|141785661|SUPERIORITY|||||||0.461|||||||Mixed Models Analysis|||||||0.461
71146215|NCT01280903|141785662|SUPERIORITY|||||||0.18|||||||Mixed Models Analysis|||||||0.180
71146216|NCT01280903|141785663|SUPERIORITY|||||||0.258|||||||Mixed Models Analysis|||||||0.258
71146217|NCT01280903|141785664|SUPERIORITY|||||||0.416|||||||Mixed Models Analysis|||||||0.416
71146218|NCT01280903|141785665|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
71146219|NCT01280903|141785666|SUPERIORITY|||||||0.272||||||p=0.272 for None to very low|Mixed Models Analysis|||||||0.272
71146220|NCT01280903|141785666|SUPERIORITY|||||||0.823||||||p=0.823 for Light|Mixed Models Analysis|||||||0.823
71146221|NCT01280903|141785666|SUPERIORITY|||||||0.076||||||p=0.076 for Moderate-to-vigorous|Mixed Models Analysis|||||||0.076
71146222|NCT01280903|141785667|SUPERIORITY|||||||0.561|||||||Mixed Models Analysis|||||||0.561
71146223|NCT01280903|141785668|SUPERIORITY|||||||0.856|||||||Mixed Models Analysis|||||||0.856
71146224|NCT01280903|141785669|SUPERIORITY|||||||0.292|||||||Mixed Models Analysis|||||||0.292
71146225|NCT01280903|141785670|SUPERIORITY|||||||0.396|||||||Mixed Models Analysis|||||||0.396
71146226|NCT01280903|141785671|SUPERIORITY|||||||0.424|||||||Mixed Models Analysis|||||||0.424
71146227|NCT01280903|141785672|SUPERIORITY|||||||0.586|||||||Mixed Models Analysis|||||||0.586
71146228|NCT01280903|141785673|SUPERIORITY|||||||0.596|||||||Mixed Models Analysis|||||||0.596
71146229|NCT01280903|141785674|SUPERIORITY|||||||0.639|||||||Mixed Models Analysis|||||||0.639
71146230|NCT01280903|141785675|SUPERIORITY|||||||0.466|||||||Mixed Models Analysis|||||||0.466
71146231|NCT01280903|141785676|SUPERIORITY|||||||0.322||||||p=0.322 for Short Form-36v2 Mental Component|Mixed Models Analysis|||||||0.322
71146232|NCT01280903|141785676|SUPERIORITY|||||||0.979||||||p=0.979 for Short Form-36v2 Physical Component|Mixed Models Analysis|||||||0.979
71146233|NCT01280903|141785677|SUPERIORITY|||||||0.71||||||p=0.710 for Exercise Barriers Self-Efficacy|Mixed Models Analysis|||||||0.710
71146234|NCT01280903|141785677|SUPERIORITY|||||||0.133||||||p=0.133 for Exercise Self-Efficacy|Mixed Models Analysis|||||||0.133
71146235|NCT01280903|141785678|SUPERIORITY|||||||0.005||||||p=0.005 for Arthritis Self Efficacy Pain|Mixed Models Analysis|||||||0.005
71146236|NCT01280903|141785678|SUPERIORITY|||||||0.948||||||p=0.948 for Arthritis Self Efficacy Function|Mixed Models Analysis|||||||0.948
71146237|NCT01280903|141785678|SUPERIORITY|||||||0.663||||||p=0.663 for Arthritis Self Efficacy Other Symptoms|Mixed Models Analysis|||||||0.663
71146238|NCT01280903|141785679|SUPERIORITY|||||||0.001||||||p=0.001 for Perceived Therapeutic Efficacy of Exercise and Arthritis|Mixed Models Analysis|||||||0.001
71146239|NCT01280903|141785679|SUPERIORITY|||||||0.031||||||p=0.031 for Perceived Therapeutic Efficacy of Exercise and Hypertension|Mixed Models Analysis|||||||0.031
71146240|NCT01280903|141785680|SUPERIORITY|||||||0.816|||||||Mixed Models Analysis|||||||0.816
71146241|NCT01280903|141785681|SUPERIORITY|||||||0.895|||||||Mixed Models Analysis|||||||0.895
71146242|NCT01280903|141785682|SUPERIORITY|||||||0.26|||||||Mixed Models Analysis|||||||0.260
71146243|NCT01280903|141785683|SUPERIORITY|||||||0.993|||||||Mixed Models Analysis|||||||0.993
71146244|NCT01280903|141785684|SUPERIORITY|||||||0.947|||||||Mixed Models Analysis|||||||0.947
71146245|NCT01280903|141785685|SUPERIORITY|||||||0.406||||||p=0.406 for Short Form-36v2 Mental Component|Mixed Models Analysis|||||||0.406
71146246|NCT01280903|141785685|SUPERIORITY|||||||0.826||||||p=0.826 for Short Form-36v2 Physical Component|Mixed Models Analysis|||||||0.826
71146247|NCT01280903|141785686|SUPERIORITY|||||||0.95||||||p=0.950 for Exercise Barriers Self-Efficacy|Mixed Models Analysis|||||||0.950
71146248|NCT01280903|141785686|SUPERIORITY|||||||0.365||||||p=0.365 for Exercise Self-Efficacy|Mixed Models Analysis|||||||0.365
71146249|NCT01280903|141785687|SUPERIORITY|||||||0.219||||||p=0.219 for Arthritis Self Efficacy Pain|Mixed Models Analysis|||||||0.219
71146250|NCT01280903|141785687|SUPERIORITY|||||||0.34||||||p=0.340 for Arthritis Self Efficacy Function|Mixed Models Analysis|||||||0.340
71146251|NCT01280903|141785687|SUPERIORITY|||||||0.806||||||p=0.806 for Arthritis Self Efficacy Other Symptoms|Mixed Models Analysis|||||||0.806
71146252|NCT01280903|141785688|SUPERIORITY|||||||0.008||||||p=0.008 for Perceived Therapeutic Efficacy of Exercise and Arthritis|Mixed Models Analysis|||||||0.008
71146253|NCT01280903|141785688|SUPERIORITY|||||||0.12||||||p=0.120 for Perceived Therapeutic Efficacy of Exercise and Hypertension|t-test, 1 sided|||||||0.120
71146254|NCT00834977|141785722|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|101.08||||||90.0|97.23|105.09|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.09|97.23|
71146255|NCT00834977|141785723|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|99.38||||||90.0|96.63|102.22|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||102.22|96.63|
71146256|NCT00834977|141785724|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|98.48||||||90.0|95.8|101.23|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.23|95.80|
71146257|NCT00834977|141785725|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|98.72||||||90.0|86.95|112.09|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||112.09|86.95|
71146258|NCT00834977|141785726|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|95.69||||||90.0|90.54|101.14|||||Metabolite presented for informational purposes only.|||101.14|90.54|
71146259|NCT00834977|141785727|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Slope|99.43||||||90.0|96.48|102.46|||||Metabolite presented for informational purposes only.|||102.46|96.48|
71146260|NCT00834977|141785728|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|97.2||||||90.0|92.82|101.78|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.78|92.82|
71146261|NCT00834977|141785729|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|96.99||||||90.0|92.52|101.68|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.68|92.52|
71146262|NCT00834977|141785730|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|99.24||||||90.0|96.21|102.35|||||Metabolite presented for informational purposes only.|||102.35|96.21|
71146263|NCT01231984|141785738|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two one-sided 95% confidence limits for the difference in HbA1c between the 4mm PN and the 8mm PN was calculated. Equivalence limits for HbA1C were defined a-priori as +/- 0.4% units.|Effect of 4mm versus 8mm PN on HbA1c|-0.076|||||TWO_SIDED|95.0|-0.209|0.058|||Two one-sided 95% confidence limits|For equivalence testing, a 95% test is the same as two one-sided 95% confidence limits.||General linear models with baseline as a covariate, needle type, period, and randomization sequence as fixed effects, and subject as random effect were fit to the data.||0.058|-0.209|
71146264|NCT01231984|141785739|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two one-sided 95% confidence limits for the difference in HbA1c between the 4 mm PN and the longer PNs (pooled) was calculated. Equivalence limits for HbA1c were defined a-priori as +/- 0.4% units.|Effect of 4mm PN vs. longer PN on HbA1c|-0.09|||||TWO_SIDED|95.0|-0.23|0.051|||Two one-sided 95% confidence limits|For equivalence testing, a 95% test is the same as two one-sided 95% confidence limits.||General linear models with baseline as a covariate, needle type, period, and randomization sequence as fixed effects, and subject as random effect were fit to the data.||0.051|-0.23|
70955132|NCT03377699|141413591|NON_INFERIORITY|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% CI for mean treatment difference in HbA1c is strictly below 0.4%.|Mean treatment difference|-0.11|||<|0.0001|TWO_SIDED|95.0|-0.31|0.08|||ANCOVA|||Primary Estimand. Imputation of missing data was done within two groups of participants defined by randomised treatment arm based on a multiple imputation approach (x1000). For each of the 1000 imputed datasets last planned HbA1c prior to delivery after GW 16 was analysed using an ANCOVA with treatment, region and the stratification factor as categorical fixed effects and a pregnancy status at randomisation-by-baseline HbA1c interaction.||0.08|-0.31|<0.0001
70955133|NCT03377699|141413591|EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% CI for mean treatment difference in HbA1c is strictly below 0.4%.|Mean treatment difference|-0.08||||0.3881|TWO_SIDED|95.0|-0.27|0.11|||ANCOVA|||Secondary Estimand. Imputation of missing data was done within two groups of participants defined by randomised treatment arm based on a multiple imputation approach (x1000). For each of the 1000 imputed datasets last planned HbA1c prior to delivery after GW 16 was analysed using an ANCOVA with treatment, region and the stratification factor as categorical fixed effects and a pregnancy status at randomisation-by-baseline HbA1c interaction.||0.11|-0.27|0.3881
70955134|NCT00307684|141413617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.89||||0.2586||95.0|-2.2055|7.9774||No adjustment for multiplicity was performed. threshold for significance: 0.05 (2-sided)|ANCOVA|treatment, sex and country as factors, age and baseline sum of inattention and hyperactivity/impulsivity scores as covariate||Based on preliminary results of a controlled study in adults with MPH, the mean (SD=9) change in CAARS total score from randomization to the 4 week post-randomization endpoint was estimated as +2.5 for PR OROS MPH and +14 for placebo. slightly more conservative, a mean change of 3 in the PR OROS MPH group and a mean increase of 10 in the placebo group were expected. With a two-sided type-I error of 5% and a power of 90%, 37 eligible subjects per group were required.||7.9774|-2.2055|0.2586
70955135|NCT00307684|141413620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3942||||0.2616||95.0|-12.1928|3.4044||No adjustment for multiplicity was performed.|ANCOVA|ANCOVA on the ranks with sex, treatment and country as factors and age and baseline score as a covariate||||3.4044|-12.1928|0.2616
70955136|NCT00307684|141413621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.39||||0.5458||95.0|-5.5469|10.3213|||ANCOVA|treatment and country as factors baseline score as covariate||||10.3213|-5.5469|0.5458
70955137|NCT02580305|141413622|SUPERIORITY|||||||0.41||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.41
70955138|NCT02580305|141413622|SUPERIORITY|||||||0.9||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.90
70955139|NCT02580305|141413623|SUPERIORITY|||||||0.46||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.46
70874008|NCT02509156|141232750|SUPERIORITY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|1.14||0.993|TWO_SIDED|95.0|-3.05|1.74|||ANCOVA||Confidence intervals based on t-test|The change in scar percent was compared using ANCOVA analyses adjusting for baseline values.||1.74|-3.05|0.993
70874009|NCT02509156|141232751|SUPERIORITY||slope of time|-0.44|STANDARD_ERROR_OF_MEAN|0.29||0.151|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope"|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.151
70874010|NCT02509156|141232752|SUPERIORITY||Mean Difference (Final Values)|38.03|STANDARD_ERROR_OF_MEAN|20.96||0.056|TWO_SIDED|95.0|-5.84|81.89|||ANCOVA||Confidence intervals based on t-test|The change in distance walked was compared using ANCOVA analyses adjusting for baseline values.||81.89|-5.84|0.056
70874011|NCT02509156|141232753|SUPERIORITY||slope of time|2.82|STANDARD_ERROR_OF_MEAN|5.06||0.583|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope"|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.583
70874012|NCT02509156|141232754|SUPERIORITY||Mean Difference (Final Values)|-12.82|STANDARD_ERROR_OF_MEAN|8.37||0.048|TWO_SIDED|95.0|-30.49|4.84|||ANCOVA||Confidence intervals based on t-test|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.||4.84|-30.49|0.048
70874013|NCT02509156|141232755|SUPERIORITY||slope of time|-8.07|STANDARD_ERROR_OF_MEAN|1.86||0.0002|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.0002
70874014|NCT02509156|141232756|SUPERIORITY||Mean Difference (Final Values)|-315.8|STANDARD_ERROR_OF_MEAN|295.0||0.199|TWO_SIDED|95.0|-947.5|315.8|||ANCOVA||Confidence intervals based on t-test|The change in NT-proBNP was compared using ANCOVA analyses adjusting for baseline values. Data log transformed. p-values were obtained from transformed data.||315.80|-947.50|0.199
70874015|NCT02509156|141232757|SUPERIORITY||slope of time|-23.391|STANDARD_ERROR_OF_MEAN|202.08||0.229|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope"|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported. Log transformation used for the regression. p-values were obtained from transformed data.||||0.229
70874016|NCT01750242|141232790|SUPERIORITY_OR_OTHER_LEGACY||% of leads|86.5|||||ONE_SIDED|95.0|73.7|||||||A 95% lower confidence bound was calculated on the percentage of leads where an overlap existed. A subject may have 1 or 2 leads included in the analysis.|||73.7|
70874017|NCT01750242|141232791|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-22.5|STANDARD_DEVIATION|8.7|||TWO_SIDED|95.0|-26.5|-18.4||||||Summary statistics on the UPDRS III score. A higher score is more motor dysfunction.||-18.4|-26.5|
70874018|NCT03765918|141232795|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \& Nurminen method stratified by primary tumor site and tumor stage.|Difference in Percentage|9.3|||<|1e-05|TWO_SIDED|95.0|6.7|12.8||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen|||||12.8|6.7|<0.00001
70874019|NCT03765918|141232796|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \& Nurminen method stratified by primary tumor site and tumor stage.|Difference in Percentage|13.7|||<|1e-05|TWO_SIDED|95.0|9.7|18.7||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen|||||18.7|9.7|<0.00001
70955140|NCT02580305|141413623|SUPERIORITY|||||||0.48||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.48
70955141|NCT02580305|141413624|SUPERIORITY|||||||0.83||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.83
70955142|NCT02580305|141413624|SUPERIORITY|||||||0.24||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.24
71146265|NCT01231984|141785740|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.36|||<|0.05|ONE_SIDED|95.0|0.37|||p\< 0.05 was considered statistically significant in this study|t-test, 1 sided|||"Subjects rated the level of pain experienced when using the PN assigned for use during Study Period 2 compared to the PN assigned for use in Study Period 1. By placing a mark on a line, whose midpoint(anchor) was designated as 0, and represented equivalent pain with assigned PNs, ratings on the continuum represented the degree to which the PN used in the second Study Period was less than or greater than the PN used during the first Study Period."|||0.37|<0.05
71146266|NCT01231984|141785741|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|30.83|||<|0.05|ONE_SIDED|95.0|18.54|||p\< 0.05 was considered statistically significant in this study.|t-test, 1 sided||||||18.54|<0.05
71146267|NCT01231984|141785743|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two one-sided 95% confidence limits for the difference in HbA1c between the 4mm PN and the 12.7mm PN was calculated. Equivalence limits for HbA1C were defined a-priori as +/- 0.4% units|Effect of 4 mm vs.12.7mm PN on HbA1c|-0.095|||||TWO_SIDED|95.0|-0.19|0.0|||Two one-sided 95% confidence limit|For equivalence testing, a 95% test is the same as two one-sided 95% confidence limits.||General linear models with baseline as a covariate, needle type, period, and randomization sequence as fixed effects, and subject as random effect were fit to the data.||-0.000|-0.190|
70874020|NCT03765918|141232797|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \& Nurminen method stratified by primary tumor site and tumor stage.|Difference in Percentage|9.8|||<|1e-05|TWO_SIDED|95.0|7.0|13.3||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen|||||13.3|7.0|<0.00001
70955143|NCT02580305|141413625|SUPERIORITY|||||||0.17||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.17
71146268|NCT01968447|141785745|SUPERIORITY_OR_OTHER_LEGACY|||||||0.59|TWO_SIDED||||||Mixed Models Analysis|||||||0.59
71146269|NCT02766023|141785752|SUPERIORITY||Risk Difference (RD)|0.04||||0.467|TWO_SIDED|95.0|-0.1|0.18|||Fisher Exact|||||0.18|-0.10|0.467
71146270|NCT02766023|141785753|SUPERIORITY||Odds Ratio (OR)|0.54||||0.031|TWO_SIDED|95.0|0.3|0.95|||Chi-squared|||||0.95|0.30|0.031
70874021|NCT03765918|141232798|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \& Nurminen method stratified by primary tumor site and tumor stage.|Difference in Percentage|3.0||||0.0006|TWO_SIDED|95.0|1.5|5.3||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen|||||5.3|1.5|0.0006
70874022|NCT03765918|141232799|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \& Nurminen method stratified by primary tumor site and tumor stage.|Difference in Percentage|4.2||||0.0011|TWO_SIDED|95.0|2.1|7.6||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen|||||7.6|2.1|0.0011
70874023|NCT03765918|141232800|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \& Nurminen method stratified by primary tumor site and tumor stage.|Difference in Percentage|3.1||||0.0006|TWO_SIDED|95.0|1.6|5.6||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen|||||5.6|1.6|0.0006
71146271|NCT02766023|141785754|SUPERIORITY||Risk Difference (RD)|0.03||||0.643|TWO_SIDED|95.0|-0.08|0.15|||Chi-squared|||Analysis is for self-reported compliance||0.15|-0.08|0.643
71146272|NCT02766023|141785754|SUPERIORITY||Risk Difference (RD)|0.05||||0.446|TWO_SIDED|95.0|-0.07|0.17|||Chi-squared|||Analysis is for compliance assessed by staining.||0.17|-0.07|0.446
70874024|NCT03765918|141232807|OTHER|Based on a constrained longitudinal data analysis (cLDA) model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-1.29||||0.4671|TWO_SIDED|95.0|-4.78|2.2||Two-sided p-value based on cLDA model.|cLDA model|||||2.20|-4.78|0.4671
70874025|NCT03765918|141232808|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-3.03||||0.1606|TWO_SIDED|95.0|-7.27|1.21||Two-sided p-value based on cLDA model.|cLDA model|||||1.21|-7.27|0.1606
71146273|NCT02766023|141785763|SUPERIORITY||Odds Ratio (OR)|79.64|||<|0.001|TWO_SIDED|95.0|29.02|218.57|||Chi-squared|||||218.57|29.02|<0.001
71146274|NCT02766023|141785771|SUPERIORITY||Odds Ratio (OR)|72.78|||<|0.001|TWO_SIDED|95.0|28.07|188.66|||Chi-squared|||||188.66|28.07|<0.001
71146275|NCT02766023|141785772|SUPERIORITY||Odds Ratio (OR)|0.54||||0.03|TWO_SIDED|95.0|0.31|0.94|||Chi-squared|||||0.94|0.31|0.030
71146276|NCT04026113|141785784|SUPERIORITY||Difference|1.17|STANDARD_ERROR_OF_MEAN|0.264|<|0.0001|TWO_SIDED|95.0|0.651|1.689||ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA|||||1.689|0.651|< 0.0001
70874026|NCT03765918|141232809|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-1.41||||0.4374|TWO_SIDED|95.0|-4.96|2.15||Two-sided p-value based on cLDA model.|cLDA model|||||2.15|-4.96|0.4374
70955144|NCT02580305|141413625|SUPERIORITY|||||||0.14||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.14
71146277|NCT04026113|141785784|SUPERIORITY|||||||0.4323||||||Treatment-by-Age Group Interaction P-value: Interaction P-value base on ANCOVA model with treatment, age group, treatment-by-age group interaction as factors and baseline value as a covariate.|ANCOVA|||||||0.4323
71146278|NCT04026113|141785786|SUPERIORITY||Difference|0.423|STANDARD_ERROR_OF_MEAN|0.109||0.0001|TWO_SIDED|95.0|0.208|0.638||ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA|||||0.638|0.208|0.0001
71146279|NCT04026113|141785786|SUPERIORITY|||||||0.4381||||||Treatment-by-Age Group Interaction P-value: Interaction P-value base on ANCOVA model with treatment, age group, treatment-by-age group interaction as factors and baseline value as a covariate.|ANCOVA|||||||0.4381
71146280|NCT04613362|141785804|SUPERIORITY||Odds Ratio (OR)|0.82||||0.61|TWO_SIDED|95.0|0.34|1.97||adjusted for gender which is included as a covariate|Mixed Models Analysis|||||1.97|0.34|0.61
71146281|NCT04613362|141785806|SUPERIORITY||Mean Difference (Net)|-8.8028|STANDARD_ERROR_OF_MEAN|6.3895||0.1724|TWO_SIDED|95.0|-21.5314|3.9257|||Mixed Models Analysis|||3 month||3.9257|-21.5314|0.1724
71146282|NCT04613362|141785806|SUPERIORITY||Mean Difference (Net)|-4.6533|STANDARD_ERROR_OF_MEAN|5.9929||0.4399|TWO_SIDED|95.0|-16.5917|7.2851|||Mixed Models Analysis|||6 months||7.2851|-16.5917|0.4399
71146283|NCT04613362|141785807|SUPERIORITY||Mean Difference (Net)|18.7886|STANDARD_ERROR_OF_MEAN|18.0826||0.3021|TWO_SIDED|95.0|-17.2261|54.8032|||Mixed Models Analysis|||3 months||54.8032|-17.2261|0.3021
71146284|NCT04613362|141785807|SUPERIORITY||Mean Difference (Net)|-5.1996|STANDARD_ERROR_OF_MEAN|17.1338||0.7624|TWO_SIDED|95.0|-39.3245|28.9254|||Mixed Models Analysis|||6 months||28.9254|-39.3245|0.7624
71146285|NCT04613362|141785808|SUPERIORITY||Mean Difference (Net)|5.9613|STANDARD_ERROR_OF_MEAN|4.3867||0.1783|TWO_SIDED|95.0|-2.7794|14.7019|||Mixed Models Analysis|||3 months||14.7019|-2.7794|0.1783
71146286|NCT04613362|141785808|SUPERIORITY||Mean Difference (Net)|-0.2145|STANDARD_ERROR_OF_MEAN|4.1565||0.959|TWO_SIDED|95.0|-8.4965|8.0675|||Mixed Models Analysis|||6 months||8.0675|-8.4965|0.959
71146287|NCT04613362|141785809|SUPERIORITY||Mean Difference (Net)|-12.6627|STANDARD_ERROR_OF_MEAN|7.3097||0.0873|TWO_SIDED|95.0|-27.2243|1.8989|||Mixed Models Analysis|||3 months||1.8989|-27.2243|0.0873
71146288|NCT04613362|141785809|SUPERIORITY||Mean Difference (Net)|-7.3578|STANDARD_ERROR_OF_MEAN|6.8559||0.2866|TWO_SIDED|95.0|-21.0154|6.2999|||Mixed Models Analysis|||6 months||6.2999|-21.0154|0.2866
71146289|NCT04613362|141785811|SUPERIORITY||Mean Difference (Net)|-1.5655|STANDARD_ERROR_OF_MEAN|1.4313||0.2776|TWO_SIDED|95.0|-4.4168|1.2859|||Mixed Models Analysis|||3 months||1.2859|-4.4168|0.2776
71146290|NCT04613362|141785811|SUPERIORITY||Mean Difference (Net)|0.7202|STANDARD_ERROR_OF_MEAN|1.6492||0.6636|TWO_SIDED|95.0|-2.5651|4.0055|||Mixed Models Analysis|||6 months||4.0055|-2.5651|0.6636
70955145|NCT02580305|141413626|SUPERIORITY|||||||0.79||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.79
70955146|NCT02580305|141413626|SUPERIORITY|||||||0.92||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.92
70955147|NCT01247285|141413644|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|107.81|||||TWO_SIDED|90.0|97.37|119.38|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||119.38|97.37|
71146291|NCT04613362|141785812|SUPERIORITY||Mean Difference (Net)|2.3254|STANDARD_ERROR_OF_MEAN|1.6911||0.1733|TWO_SIDED|95.0|-1.0443|5.695|||Mixed Models Analysis|||3 months||5.695|-1.0443|0.1733
71146292|NCT04613362|141785812|SUPERIORITY||Mean Difference (Net)|-0.5408|STANDARD_ERROR_OF_MEAN|1.622||0.7398|TWO_SIDED|95.0|-3.7726|2.6911|||Mixed Models Analysis|||6 months||2.6911|-3.7726|0.7398
71146293|NCT04613362|141785813|SUPERIORITY||Mean Difference (Net)|-0.1491|STANDARD_ERROR_OF_MEAN|1.5551||0.9239|TWO_SIDED|95.0|-3.2476|2.9494|||Mixed Models Analysis|||Physical Component Scale - 3 months||2.9494|-3.2476|0.9239
71146294|NCT04613362|141785813|SUPERIORITY||Mean Difference (Net)|-0.2879|STANDARD_ERROR_OF_MEAN|1.4735||0.8456|TWO_SIDED|95.0|-3.2238|2.6481|||Mixed Models Analysis|||Physical Component Scale - 6 months||2.6481|-3.2238|0.8456
71146295|NCT04613362|141785813|SUPERIORITY||Mean Difference (Net)|-0.1757|STANDARD_ERROR_OF_MEAN|2.3798||0.9413|TWO_SIDED|95.0|-4.9175|4.5661|||Mixed Models Analysis|||Mental Component Scale - 3 months||4.5661|-4.9175|0.9413
71146296|NCT04613362|141785813|SUPERIORITY||Mean Difference (Net)|-2.9597|STANDARD_ERROR_OF_MEAN|2.2549||0.1934|TWO_SIDED|95.0|-7.4526|1.5333|||Mixed Models Analysis|||Mental Component Scale - 6 months||1.5333|-7.4526|0.1934
71146297|NCT04613362|141785814|SUPERIORITY||Mean Difference (Net)|3.0999|STANDARD_ERROR_OF_MEAN|2.1004||0.1442|TWO_SIDED|95.0|-1.0852|7.2849|||Mixed Models Analysis|||3 months||7.2849|-1.0852|0.1442
71146298|NCT04613362|141785814|SUPERIORITY||Mean Difference (Net)|2.0675|STANDARD_ERROR_OF_MEAN|2.036||0.3132|TWO_SIDED|95.0|-1.9892|6.1243|||Mixed Models Analysis|||6 months||6.1243|-1.9892|0.3132
71146299|NCT02218372|141785817|OTHER||adjusted treatment difference|7.5|||||TWO_SIDED|95.0|-7.4|23.9||||||Adjusted difference of CCR at EOT + 2 Days. Adjusted treatment difference of proportions was calculated using a stratified Cochran-Mantel-Haenszel (CMH) method. Newcombe 95% confidence intervals (CIs) presented for adjusted treatment difference.||23.9|-7.4|
71146300|NCT02218372|141785818|OTHER||adjusted treatment difference|16.3|||||TWO_SIDED|95.0|1.8|34.2||||||Adjusted difference of SCR at EOT +9 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||34.2|1.8|
71146301|NCT02218372|141785819|OTHER||adjusted treatment difference|21.3|||||TWO_SIDED|95.0|4.5|37.7||||||Adjusted difference of GC at EOT +9 days. Adjusted treatment difference of rates was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||37.7|4.5|
71146302|NCT02218372|141785820|OTHER||adjusted treatment difference|-16.3|||||TWO_SIDED|95.0|-34.2|-1.8||||||Adjusted difference of CDAD recurrence at EOT +9 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||-1.8|-34.2|
71146303|NCT02218372|141785821|OTHER||adjusted treatment difference|17.2|||||TWO_SIDED|95.0|1.9|35.6||||||Adjusted difference of SCR at EOT +16 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||35.6|1.9|
71146304|NCT02218372|141785822|OTHER||adjusted treatment difference|19.4|||||TWO_SIDED|95.0|2.3|35.9||||||Adjusted difference of GC at EOT +16 days. Adjusted treatment difference of rates was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||35.9|2.3|
71146305|NCT02218372|141785823|OTHER||adjusted treatment difference|-17.2|||||TWO_SIDED|95.0|-35.6|-1.9||||||Adjusted difference of CDAD Recurrence at EOT +16 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||-1.9|-35.6|
71146306|NCT02218372|141785824|OTHER||adjusted treatment difference|15.8|||||TWO_SIDED|95.0|-0.5|34.5||||||Adjusted difference of SCR at EOT +23 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||34.5|-0.5|
71146307|NCT02218372|141785825|OTHER||adjusted treatment difference|18.8|||||TWO_SIDED|95.0|1.5|35.3||||||Adjusted difference of GC at EOT +23 days. Adjusted treatment difference of rates was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||35.3|1.5|
71146308|NCT02218372|141785826|OTHER||adjusted treatment difference|-15.8|||||TWO_SIDED|95.0|-34.5|0.5||||||Adjusted difference of CDAD Recurrence at EOT +23 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||0.5|-34.5|
71146309|NCT02218372|141785827|OTHER||adjusted treatment difference|15.8|||||TWO_SIDED|95.0|-0.5|34.5||||||Adjusted difference of SCR at EOS (EOT +30 days). Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||34.5|-0.5|
71146310|NCT02218372|141785828|OTHER||adjusted treatment difference|18.8|||||TWO_SIDED|95.0|1.5|35.3||||||Adjusted difference of GC at EOS (EOT +30 days). Adjusted treatment difference of rates was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||35.3|1.5|
71146311|NCT02218372|141785829|OTHER|Newcombe 95% CIs presented for adjusted treatment difference.|adjusted treatment difference|-15.8|||||TWO_SIDED|95.0|-34.5|0.5||||||Adjusted difference of CDAD recurrence at EOS/EOT +30 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||0.5|-34.5|
71146312|NCT02218372|141785830|OTHER|||||||0.579|||||||Log Rank|||Time to resolution of diarrhea.||||0.579
71146313|NCT02218372|141785831|OTHER|||||||0.023|||||||Log Rank|||Time to recurrence of CDAD.||||0.023
70874027|NCT03765918|141232810|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.39||||0.8379|TWO_SIDED|95.0|-3.35|4.13||Two-sided p-value based on cLDA model.|cLDA model|||||4.13|-3.35|0.8379
70874028|NCT03765918|141232811|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-0.39||||0.8643|TWO_SIDED|95.0|-4.84|4.07||Two-sided p-value based on cLDA model.|cLDA model|||||4.07|-4.84|0.8643
70874029|NCT03765918|141232812|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-0.29||||0.8813|TWO_SIDED|95.0|-4.12|3.54||Two-sided p-value based on cLDA model.|cLDA model|||||3.54|-4.12|0.8813
70874030|NCT03765918|141232819|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.34||||0.8287|TWO_SIDED|95.0|-2.76|3.45||Two-sided p-value based on cLDA model.|cLDA model|||||3.45|-2.76|0.8287
70874031|NCT03765918|141232820|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.53||||0.7761|TWO_SIDED|95.0|-3.12|4.18||Two-sided p-value based on cLDA model.|cLDA model|||||4.18|-3.12|0.7761
70874032|NCT03765918|141232821|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.65||||0.688|TWO_SIDED|95.0|-2.54|3.84||Two-sided p-value based on cLDA model.|cLDA model|||||3.84|-2.54|0.6880
70874033|NCT03765918|141232822|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-1.45||||0.3858|TWO_SIDED|95.0|-4.73|1.83||Two-sided p-value based on cLDA model.|cLDA model|||||1.83|-4.73|0.3858
70874034|NCT03765918|141232823|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-2.45||||0.237|TWO_SIDED|95.0|-6.53|1.62||Two-sided p-value based on cLDA model.|cLDA model|||||1.62|-6.53|0.2370
70874035|NCT03765918|141232824|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-1.76||||0.3138|TWO_SIDED|95.0|-5.2|1.67||Two-sided p-value based on cLDA model.|cLDA model|||||1.67|-5.20|0.3138
70874036|NCT03765918|141232831|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-3.28||||0.1763|TWO_SIDED|95.0|-8.05|1.48||Two-sided p-value based on cLDA model.|cLDA model|||||1.48|-8.05|0.1763
70874037|NCT03765918|141232832|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-1.18||||0.6882|TWO_SIDED|95.0|-6.95|4.59||Two-sided p-value based on cLDA model.|cLDA model|||||4.59|-6.95|0.6882
70874038|NCT03765918|141232833|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-2.52||||0.3103|TWO_SIDED|95.0|-7.39|2.35||Two-sided p-value based on cLDA model.|cLDA model|||||2.35|-7.39|0.3103
70874039|NCT03765918|141232834|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-0.48||||0.8475|TWO_SIDED|95.0|-5.41|4.45||Two-sided p-value based on cLDA model.|cLDA model|||||4.45|-5.41|0.8475
70955148|NCT01247285|141413645|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|100.69|||||TWO_SIDED|90.0|92.9|109.14|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||109.14|92.90|
71146314|NCT02753283|141785840|SUPERIORITY||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|1.48||0.007|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.007
71146315|NCT02753283|141785840|SUPERIORITY||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|1.09||0.018|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.018
71146316|NCT02753283|141785841|SUPERIORITY||Mean Difference (Final Values)|3.99|STANDARD_ERROR_OF_MEAN|1.45||0.014|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.014
71146317|NCT02753283|141785841|SUPERIORITY||Mean Difference (Final Values)|5.16|STANDARD_ERROR_OF_MEAN|1.45||0.002|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.002
71146318|NCT02753283|141785842|SUPERIORITY||Mean Difference (Final Values)|2.54|STANDARD_ERROR_OF_MEAN|1.26||0.06|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.060
71146319|NCT02753283|141785842|SUPERIORITY||Mean Difference (Final Values)|2.45|STANDARD_ERROR_OF_MEAN|1.22||0.055|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.055
71146320|NCT02753283|141785843|SUPERIORITY||Mean Difference (Final Values)|2.21|STANDARD_ERROR_OF_MEAN|1.37||0.112|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.112
71146321|NCT02753283|141785843|SUPERIORITY||Mean Difference (Final Values)|2.46|STANDARD_ERROR_OF_MEAN|1.34||0.07|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.070
71146322|NCT02753283|141785844|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|1.39||0.904|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.904
71146323|NCT02753283|141785844|SUPERIORITY||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|2.29||0.616|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.616
71146324|NCT02753283|141785845|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||<.001
71146325|NCT02753283|141785845|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.03||0.005|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.005
71146326|NCT02753283|141785846|SUPERIORITY||Mean Difference (Final Values)|-26.2|STANDARD_ERROR_OF_MEAN|6.0||0.001|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.001
71146327|NCT02753283|141785846|SUPERIORITY||Mean Difference (Final Values)|-8.2|STANDARD_ERROR_OF_MEAN|3.9||0.038|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.038
71146328|NCT04386291|141785847|SUPERIORITY||Mean Difference (Final Values)|-1.54||||0.071|TWO_SIDED||||||t-test, 1 sided|||||||0.071
71146329|NCT04386291|141785847|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.46|TWO_SIDED||||||t-test, 1 sided|||||||0.46
71146330|NCT04386291|141785848|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.01|TWO_SIDED||||||t-test, 1 sided|||||||0.01
71146331|NCT04386291|141785848|SUPERIORITY||Mean Difference (Final Values)|-1.76||||0.04|TWO_SIDED||||||t-test, 1 sided|||||||0.04
71146332|NCT04386291|141785849|SUPERIORITY||Mean Difference (Final Values)|-1.47||||0.08|TWO_SIDED||||||t-test, 1 sided|||||||0.08
71146333|NCT04386291|141785849|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.5|TWO_SIDED||||||t-test, 1 sided|||||||0.5
71146334|NCT04386291|141785850|SUPERIORITY||Mean Difference (Final Values)|-0.68||||0.25|TWO_SIDED||||||t-test, 1 sided|||||||0.25
71146335|NCT04386291|141785850|SUPERIORITY||Mean Difference (Final Values)|-1.54||||0.065|TWO_SIDED||||||t-test, 1 sided|||||||0.065
71146336|NCT04386291|141785851|SUPERIORITY||Mean Difference (Final Values)|1.24||||0.88|TWO_SIDED||||||t-test, 1 sided|||||||0.88
71146337|NCT04386291|141785851|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.7|TWO_SIDED||||||t-test, 1 sided|||||||0.7
71146338|NCT04386291|141785852|SUPERIORITY||Mean Difference (Final Values)|-1.84||||0.038|TWO_SIDED||||||t-test, 1 sided|||||||0.038
71146339|NCT04386291|141785852|SUPERIORITY||Mean Difference (Final Values)|-1.59||||0.059|TWO_SIDED||||||t-test, 1 sided|||||||0.059
71146340|NCT04386291|141785853|SUPERIORITY||Median Difference (Final Values)|1.58||||0.9|TWO_SIDED||||||t-test, 1 sided|||Reappraisal subscale analysis||||0.9
71146341|NCT04386291|141785853|SUPERIORITY||Mean Difference (Net)|-0.73||||0.23|TWO_SIDED||||||t-test, 1 sided|||Subpression subscale analysis||||0.23
71146342|NCT04386291|141785853|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.7|TWO_SIDED||||||t-test, 1 sided|||Reappraisal subscale analysis||||0.7
70874040|NCT03765918|141232835|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-0.42||||0.8881|TWO_SIDED|95.0|-6.36|5.51||Two-sided p-value based on cLDA model.|cLDA model|||||5.51|-6.36|0.8881
70874041|NCT03765918|141232836|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-0.22||||0.9307|TWO_SIDED|95.0|-5.22|4.78||Two-sided p-value based on cLDA model.|cLDA model|||||4.78|-5.22|0.9307
70874042|NCT03765918|141232843|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|1.3||||0.5752|TWO_SIDED|95.0|-3.25|5.85||Two-sided p-value based on cLDA model.|cLDA model|||||5.85|-3.25|0.5752
70874043|NCT03765918|141232844|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.98||||0.7196|TWO_SIDED|95.0|-4.38|6.34||Two-sided p-value based on cLDA model.|cLDA model|||||6.34|-4.38|0.7196
70874044|NCT03765918|141232845|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.74||||0.7522|TWO_SIDED|95.0|-3.88|5.37||Two-sided p-value based on cLDA model.|cLDA model|||||5.37|-3.88|0.7522
70955149|NCT01247285|141413646|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|100.77|||||TWO_SIDED|90.0|93.53|108.56|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.56|93.53|
70874045|NCT03765918|141232846|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-0.24||||0.9255|TWO_SIDED|95.0|-5.3|4.82||Two-sided p-value based on cLDA model.|cLDA model|||||4.82|-5.30|0.9255
70874046|NCT03765918|141232847|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|2.22||||0.4926|TWO_SIDED|95.0|-4.15|8.6||Two-sided p-value based on cLDA model.|cLDA model|||||8.60|-4.15|0.4926
70874047|NCT03765918|141232848|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.99||||0.7087|TWO_SIDED|95.0|-4.23|6.21||Two-sided p-value based on cLDA model.|cLDA model|||||6.21|-4.23|0.7087
70874048|NCT03765918|141232855|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-2.75||||0.1654|TWO_SIDED|95.0|-6.65|1.14||Two-sided p-value based on cLDA model.|cLDA model|||||1.14|-6.65|0.1654
70874049|NCT03765918|141232856|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.26||||0.9117|TWO_SIDED|95.0|-4.29|4.8||Two-sided p-value based on cLDA model.|cLDA model|||||4.80|-4.29|0.9117
70874050|NCT03765918|141232857|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-2.22||||0.2808|TWO_SIDED|95.0|-6.25|1.82||Two-sided p-value based on cLDA model.|cLDA model|||||1.82|-6.25|0.2808
71146343|NCT04386291|141785853|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.5|TWO_SIDED||||||t-test, 1 sided|||Suppression subscale analysis||||0.5
71146344|NCT04386291|141785854|SUPERIORITY||Mean Difference (Final Values)|0.67||||0.5|TWO_SIDED||||||ANOVA|||||||0.5
71146345|NCT04386291|141785855|SUPERIORITY||mean rank difference|79.0||||0.076|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Mann-Witney was used because assumption of normality of variance was violated||||||0.076
71146346|NCT04386291|141785855|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.8|TWO_SIDED||||||t-test, 1 sided|||||||0.8
71146347|NCT05172128|141785856|OTHER||||||>|0.05|||||||t-test, 2 sided||||Paired t-test comparing baseline value to endpoint value revealed a p-value of 0.80.|||>0.05
71146348|NCT05172128|141785857|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71146349|NCT05172128|141785858|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71146350|NCT05172128|141785859|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71146351|NCT05172128|141785862|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71146352|NCT01921205|141785864|SUPERIORITY||Percent reduction over Placebo|31.72|||=|0.0003|TWO_SIDED|95.0|16.342|44.277|||ANCOVA|Seizure frequency (log transformed) is analyzed using analysis of covariance with terms for treatment, pooled center and Baseline seizure frequency.|Percent reduction over placebo is estimated as 100 x (1-exp\[LSMLacosamide-LSMPlacebo\]). Where LSM is Least Square Mean.|||44.277|16.342|=0.0003
71146353|NCT01668784|141785904|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0018|TWO_SIDED|98.52|0.57|0.93||The boundary for statistical significance required the p-value to be less than 0.0148 at the interim analyses.|Log Rank|Log-rank Test stratified by the Memorial Sloan-Kettering Cancer Center risk group, number of prior anti-angiogenic therapies, and the region.|Stratified Cox proportional hazard model. Hazard ratio (HR) was Nivolumab over Everolimus.|||0.93|0.57|0.0018
71146354|NCT01668784|141785908|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.034|TWO_SIDED|95.0|0.72|0.99|||Log Rank|Log-rank Test stratified by the Memorial Sloan-Kettering Cancer Center (MSKCC) risk group, number of prior anti-angiogenic therapies, and the region.|Stratified Cox proportional hazard model. Hazard ratio is nivolumab over everolimus.|||0.99|0.72|0.0340
70955150|NCT01247285|141413647|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|104.88|||||TWO_SIDED|90.0|98.53|111.64|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||111.64|98.53|
70955151|NCT01247285|141413648|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.64|||||TWO_SIDED|90.0|99.97|111.56|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||111.56|99.97|
70955152|NCT01247285|141413649|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|101.05|||||TWO_SIDED|90.0|94.76|107.77|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||107.77|94.76|
70955153|NCT01416389|141413650|SUPERIORITY_OR_OTHER_LEGACY|||||||0.344|||||||t-test, 1 sided|||This measure is compared between two treatment arms using a one-sided t-test. This measure followed a normal distribution.||||0.344
70955154|NCT01416389|141413651|SUPERIORITY_OR_OTHER_LEGACY|||||||0.608|||||||Chi-squared|||||||0.608
70874051|NCT03765918|141232858|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-2.77||||0.1577|TWO_SIDED|95.0|-6.62|1.08||Two-sided p-value based on cLDA model.|cLDA model|||||1.08|-6.62|0.1577
70874052|NCT03765918|141232859|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-2.81||||0.2485|TWO_SIDED|95.0|-7.59|1.97||Two-sided p-value based on cLDA model.|cLDA model|||||1.97|-7.59|0.2485
70955155|NCT01416389|141413653|SUPERIORITY_OR_OTHER_LEGACY|||||||0.365|||||||Chi-squared|||||||0.365
70955156|NCT03026075|141413737|SUPERIORITY||||||<|0.01|||||||McNemar|||"The primary objective of the study is to evaluate the effectiveness of MCS in cleansing a poorly prepared colon.~A sample size of 47 patients is required as per a McNemar test to determine that the paired discordant proportions are significantly different under the followings assumptions:~Probability of Type I Error (α) = 0.05, Power (1 - β) = 0.8 Proportion switching from + to - = 0, Proportion switching from - to + = 0.6 Potential of dropout 10% (i.e. 4 cases)"||||<0.01
70955157|NCT01468181|141413792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.77|||<|0.001|TWO_SIDED|95.0|-1.87|-1.67|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HbA1c at 26 Weeks||-1.67|-1.87|<0.001
70955158|NCT01468181|141413792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.65|||<|0.001|TWO_SIDED|95.0|-1.75|-1.55|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HbA1c at 52 Weeks||-1.55|-1.75|<0.001
70955159|NCT01468181|141413794|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-43.9|||<|0.001|TWO_SIDED|95.0|-47.8|-40.0|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||FBG at 26 Weeks||-40.0|-47.8|<0.001
70955160|NCT01468181|141413794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.6|||<|0.001|TWO_SIDED|95.0|-46.4|-38.7|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||FBG at 52 Weeks||-38.7|-46.4|<0.001
70955161|NCT01468181|141413795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.42|||<|0.001|TWO_SIDED|95.0|-46.55|-38.29|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-morning meal at 26 Weeks||-38.29|-46.55|<0.001
70955162|NCT01468181|141413795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.6|||<|0.001|TWO_SIDED|95.0|-46.44|-38.76|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-morning meal at 52 Weeks||-38.76|-46.44|<0.001
71146355|NCT01668784|141785914|SUPERIORITY||Stratified Cox Proportional hazard Model|0.74||||0.0001|TWO_SIDED|95.0|0.63|0.86|||Log Rank|||||0.86|0.63|0.0001
70955163|NCT01468181|141413795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-68.48|||<|0.001|TWO_SIDED|95.0|-74.18|-62.79|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-morning meal at 26 Weeks||-62.79|-74.18|<0.001
70955164|NCT01468181|141413795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-66.08|||<|0.001|TWO_SIDED|95.0|-72.12|-60.04|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-morning meal at 52 Weeks||-60.04|-72.12|<0.001
71146356|NCT00311766|141785915|SUPERIORITY_OR_OTHER||ANCOVA|0.8|||>|0.05|TWO_SIDED|95.0|||||Fisher Exact|||The primary population was the Full Analysis(FA)population. The FA population included all patients who were randomized and received at least one dose of study medication and who had at least one baseline efficacy parameter recorded||||>0.05
71146357|NCT01436526|141785917|NON_INFERIORITY_OR_EQUIVALENCE|Using an estimated intra-subject coefficient of variation of less than 20% for AUC and Cmax, and a level of significance of 5%, a sample size of 25 completers was considered sufficient to conclude bioequivalence between 2\*5 mg and 1\*10 mg rivaroxaban with 90% power, if the 2 treatment means differed by 5%.|LS-Mean Ratio, Percent|108.35||||0.0438||90.0|101.59|115.57|||ANOVA|||||115.57|101.59|0.0438
71146358|NCT01436526|141785918|NON_INFERIORITY_OR_EQUIVALENCE|Using an estimated intra-subject coefficient of variation of less than 20% for AUC and Cmax, and a level of significance of 5%, a sample size of 25 completers was considered sufficient to conclude bioequivalence between 2\*5 mg and 1\*10 mg rivaroxaban with 90% power, if the 2 treatment means differed by 5%.|LS-Mean Ratio, Percent|108.19||||0.0514||90.0|101.31|115.54|||ANOVA|||||115.54|101.31|0.0514
71146359|NCT01436526|141785919|NON_INFERIORITY_OR_EQUIVALENCE|Using an estimated intra-subject coefficient of variation of less than 20% for AUC and Cmax, and a level of significance of 5%, a sample size of 25 completers was considered sufficient to conclude bioequivalence between 2\*5 mg and 1\*10 mg rivaroxaban with 90% power, if the 2 treatment means differed by 5%.|LS-Mean Ratio, Percent|111.64||||0.0685||90.0|101.14|123.23|||ANOVA|||||123.23|101.14|0.0685
71146360|NCT05178173|141785944|SUPERIORITY|||||||0.59||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.59
71146361|NCT05178173|141785944|SUPERIORITY|||||||0.18||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.18
71146362|NCT05178173|141785944|SUPERIORITY|||||||0.78||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.78
71146363|NCT05178173|141785944|SUPERIORITY|||||||0.08||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.08
71146364|NCT04272242|141785974|EQUIVALENCE|GMRs and associated 90% confidence intervals were calculated to assess the overall effect of 1HP on DTG PK.|Geometric Mean Ratio|0.92|||||TWO_SIDED|90.0|0.91|0.93|||||The numerator represents Day 28 and the denominator represents Entry.|Statistical analysis for Cmax, comparing Day 28 to Day 0.||0.93|0.91|
71146365|NCT04272242|141785975|EQUIVALENCE|GMRs and associated 90% confidence intervals were calculated to assess the overall effect of 1HP on DTG PK.|Geometric Mean Ratio|0.96|||||TWO_SIDED|90.0|0.96|0.96|||||The numerator represents Day 28 and the denominator represents Entry.|Statistical analysis for AUC0-24, comparing Day 28 to Day 0.||0.96|0.96|
70955165|NCT01468181|141413795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-48.21|||<|0.001|TWO_SIDED|95.0|-53.32|-43.09|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-midday meal at 26 Weeks||-43.09|-53.32|<0.001
71146366|NCT04272242|141785976|EQUIVALENCE|GMRs and associated 90% confidence intervals were calculated to assess the overall effect of 1HP on DTG PK.|Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.97|1.0|||||The numerator represents Day 28 and the denominator represents Entry.|Statistical analysis for Cmin, comparing Day 28 to Day 0.||1.00|0.97|
71146367|NCT02711891|141786018|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8|||||||Paired Sample T-test|||||||0.8
71146368|NCT02711891|141786018|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||Paired Sample T-test|||||||.003
71146369|NCT02711891|141786018|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||t-test, 2 sided|||||||0.002
71146370|NCT02711891|141786020|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||t-test, 1 sided|||||||0.01
71146371|NCT02711891|141786020|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|0.05|||||Chi-squared|||||||.001
71146372|NCT02711891|141786022|SUPERIORITY_OR_OTHER_LEGACY|||||||0.876||||||Comparison of mean BPM during lance procedure for L1 vs L2 Loperamide.|t-test, 1 sided|||The population BPM lance one = population BPM mean lance two. Loperamide 1= Loperamide 2. Placebo 1=Placebo 2.||||.876
71146373|NCT02711891|141786022|SUPERIORITY_OR_OTHER_LEGACY|||||||0.085||||||Comparison of the mean between HR one and HR two during the procedure for lance one will equal the mean HR lance two following loperamide gel application.|ANOVA|df 16.||Mean HR during the procedure for lance one will equal mean HR lance two following loperamide gel applciation||||.085
71146374|NCT02677493|141786026|EQUIVALENCE|"All statistical significance testing was performed at a two-sided significance level (α) of 5%.~Exceptionally, non-inferiority was tested at a one-sided CI of 97.5%."||||||0.09135|||||||ANCOVA|||To evaluate if the seroconversion (SCR) and seroprotection (SPR) rates on Day 28 after vaccination of IL-YANG Quadrivalent Influenza Vaccine Inj. meet the following criteria in all age groups of healthy male and female adults at the age of 19 or older.||||0.09135
71146375|NCT01972217|141786045|SUPERIORITY||Hazard Ratio (HR)|0.651||||0.017|TWO_SIDED|95.0|0.438|0.969|||Log Rank|||The 1-sided p-value provides a test for rejecting the null hypothesis of no treatment effect versus the superiority alternative that patients on olaparib have a lower risk of progression compared with placebo.||0.969|0.438|0.017
71146376|NCT01972217|141786058|OTHER||Odds Ratio (OR)|0.813||||0.309|TWO_SIDED|95.0|0.285|2.261||The p value was calculated with a 1-sided significance level of 2.5%.|Regression, Logistic|||||2.261|0.285|0.309
71146377|NCT01972217|141786059|OTHER||Hazard Ratio (HR)|0.781||||0.095|TWO_SIDED|95.0|0.54|1.13||The p value was calculated with a 1-sided significance level of 2.5%.|Log Rank|||Olapatib + abiraterone versus placebo + abiraterone: TFST||1.130|0.540|0.095
71146378|NCT01972217|141786059|OTHER||Hazard Ratio (HR)|0.809||||0.147|TWO_SIDED|95.0|0.545|1.201||The p value was calculated with a 1-sided significance level of 2.5%.|Log Rank|||Olaparib + abiraterone versus placebo + abiraterone: TSST||1.201|0.545|0.147
71146379|NCT01972217|141786060|OTHER||Hazard Ratio (HR)|0.911||||0.331|TWO_SIDED|95.0|0.6|1.384||The p value was calculated with a 1-sided significance level of 2.5%.|Log Rank|||||1.384|0.600|0.331
71146380|NCT01972217|141786061|OTHER||Hazard Ratio (HR)|0.788||||0.14|TWO_SIDED|95.0|0.511|1.215||The p value was calculated with a 1-sided significance level of 2.5%.|Log Rank|||||1.215|0.511|0.140
71146381|NCT03175367|141786064|SUPERIORITY||Least Squares Mean Difference|-38.5|STANDARD_ERROR_OF_MEAN|9.1|<|0.0001|TWO_SIDED|95.0|-56.5|-20.6|||Mixed Models Analysis|||||-20.6|-56.5|< .0001
71146382|NCT03175367|141786064|SUPERIORITY||Least Squares Mean Difference|-52.9|STANDARD_ERROR_OF_MEAN|9.0|<|0.0001|TWO_SIDED|95.0|-70.7|-35.1|||Mixed Models Analysis|||||-35.1|-70.7|< .0001
71146383|NCT03175367|141786064|SUPERIORITY||Least Squares Mean Difference|-56.0|STANDARD_ERROR_OF_MEAN|9.0|<|0.0001|TWO_SIDED|95.0|-73.7|-38.3|||Mixed Models Analysis|||||-38.3|-73.7|< .0001
71146384|NCT03175367|141786064|SUPERIORITY||Least Squares Mean Difference|-24.2|STANDARD_ERROR_OF_MEAN|9.3|=|0.0109|TWO_SIDED|95.0|-42.6|-5.7||P-Value is not adjusted for multiplicity|Mixed Models Analysis|||||-5.7|-42.6|= 0.0109
71146385|NCT03175367|141786064|SUPERIORITY||Least Squares Mean Difference|-50.5|STANDARD_ERROR_OF_MEAN|9.0|<|0.0001|TWO_SIDED|95.0|-68.4|-32.6|||Mixed Models Analysis|||||-32.6|-68.4|< .0001
71146386|NCT03175367|141786065|SUPERIORITY||Least Squares Mean Difference|-26.6|STANDARD_ERROR_OF_MEAN|7.2|=|0.0003|TWO_SIDED|95.0|-40.9|-12.4|||Mixed Models Analysis|||||-12.4|-40.9|= 0.0003
71146387|NCT03175367|141786065|SUPERIORITY||Least Squares Mean Difference|-42.0|STANDARD_ERROR_OF_MEAN|7.1|<|0.0001|TWO_SIDED|95.0|-56.1|-27.9|||Mixed Models Analysis|||||-27.9|-56.1|< 0.0001
71146388|NCT03175367|141786065|SUPERIORITY||Least Squares Mean Difference|-45.5|STANDARD_ERROR_OF_MEAN|7.1|<|0.0001|TWO_SIDED|95.0|-59.5|-31.5|||Mixed Models Analysis|||||-31.5|-59.5|< 0.0001
71146389|NCT03175367|141786065|SUPERIORITY||Least Squares Mean Difference|-16.6|STANDARD_ERROR_OF_MEAN|6.6|=|0.0132|TWO_SIDED|95.0|-29.7|-3.5|||Mixed Models Analysis|||||-3.5|-29.7|= 0.0132
71146390|NCT03175367|141786065|SUPERIORITY||Least Squares Mean Difference|-39.4|STANDARD_ERROR_OF_MEAN|6.4|<|0.0001|TWO_SIDED|95.0|-52.0|-26.8|||Mixed Models Analysis|||||-26.8|-52.0|< 0.0001
71146391|NCT03175367|141786066|SUPERIORITY||Least Squares Mean Difference|-21.8|STANDARD_ERROR_OF_MEAN|8.4|=|0.0111|TWO_SIDED|95.0|-38.4|-5.1|||Mixed Models Analysis|||||-5.1|-38.4|= 0.0111
71146392|NCT03175367|141786066|SUPERIORITY||Least Squares Mean Difference|-40.4|STANDARD_ERROR_OF_MEAN|8.2|<|0.0001|TWO_SIDED|95.0|-56.7|-24.0|||Mixed Models Analysis|||||-24.0|-56.7|< 0.0001
71146393|NCT03175367|141786067|SUPERIORITY||Least Squares Mean Difference|-39.3|STANDARD_ERROR_OF_MEAN|7.6|<|0.0001|TWO_SIDED|95.0|-54.4|-24.3|||Mixed Models Analysis|||||-24.3|-54.4|< 0.0001
71146394|NCT03175367|141786067|SUPERIORITY||Least Squares Mean Difference|-53.8|STANDARD_ERROR_OF_MEAN|7.6|<|0.0001|TWO_SIDED|95.0|-68.8|-38.9|||Mixed Models Analysis|||||-38.9|-68.8|< 0.0001
71146395|NCT03175367|141786067|SUPERIORITY||Least Squares Mean Difference|-58.5|STANDARD_ERROR_OF_MEAN|7.5|<|0.0001|TWO_SIDED|95.0|-73.4|-43.7|||Mixed Models Analysis|||||-43.7|-73.4|< 0.0001
71146396|NCT03175367|141786067|SUPERIORITY||Least Squares Mean Difference|-23.7|STANDARD_ERROR_OF_MEAN|8.1|=|0.0042|TWO_SIDED|95.0|-39.7|-7.7|||Mixed Models Analysis|||||-7.7|-39.7|= 0.0042
71146397|NCT03175367|141786067|SUPERIORITY||Least Squares Mean Difference|-50.9|STANDARD_ERROR_OF_MEAN|7.8|<|0.0001|TWO_SIDED|95.0|-66.4|-35.4|||Mixed Models Analysis|||||-35.4|-66.4|< 0.0001
71146398|NCT03175367|141786068|SUPERIORITY||Least Squares Mean Difference|-30.6|STANDARD_ERROR_OF_MEAN|9.7|=|0.0021|TWO_SIDED|95.0|-49.8|-11.4|||Mixed Models Analysis|||||-11.4|-49.8|= 0.0021
71146399|NCT03175367|141786068|SUPERIORITY||Least Squares Mean Difference|-54.6|STANDARD_ERROR_OF_MEAN|9.5|<|0.0001|TWO_SIDED|95.0|-73.4|-35.8|||Mixed Models Analysis|||||-35.8|-73.4|< 0.0001
71146400|NCT03175367|141786069|SUPERIORITY||Odds Ratio, log|19.4|||<|0.0001|TWO_SIDED|95.0|5.1|72.8|||Regression, Logistic|||||72.8|5.1|< 0.0001
71146401|NCT03175367|141786069|SUPERIORITY||Odds Ratio, log|23.9|||<|0.0001|TWO_SIDED|95.0|6.4|89.2|||Regression, Logistic|||||89.2|6.4|< 0.0001
71146402|NCT03175367|141786069|SUPERIORITY||Odds Ratio, log|22.1|||<|0.0001|TWO_SIDED|95.0|6.0|80.5|||Regression, Logistic|||||80.5|6.0|< 0.0001
71146403|NCT03175367|141786069|SUPERIORITY||Odds Ratio, log|8.5|||=|0.0007|TWO_SIDED|95.0|2.5|29.2|||Regression, Logistic|||||29.2|2.5|= 0.0007
71146404|NCT03175367|141786069|SUPERIORITY||Odds Ratio, log|42.3|||<|0.0001|TWO_SIDED|95.0|10.4|172.3|||Regression, Logistic|||||172.3|10.4|< 0.0001
71146405|NCT03175367|141786070|SUPERIORITY||Odds Ratio (OR)|9.6|||=|0.01|TWO_SIDED|95.0|1.7|53.5|||Regression, Logistic|||||53.5|1.7|= 0.0100
71146406|NCT03175367|141786070|SUPERIORITY||Odds Ratio (OR)|24.8|||=|0.0001|TWO_SIDED|95.0|4.7|129.9|||Regression, Logistic|||||129.9|4.7|= 0.0001
71146407|NCT03175367|141786070|SUPERIORITY||Odds Ratio (OR)|36.1|||<|0.0001|TWO_SIDED|95.0|6.7|194.7|||Regression, Logistic|||||194.7|6.7|< 0.0001
71146408|NCT03175367|141786070|SUPERIORITY||Odds Ratio (OR)|2.0|||=|0.3185|TWO_SIDED|95.0|0.5|8.2|||Regression, Logistic|||||8.2|0.5|= 0.3185
71146409|NCT03175367|141786070|SUPERIORITY||Odds Ratio (OR)|14.5|||<|0.0001|TWO_SIDED|95.0|3.9|54.2|||Regression, Logistic|||||54.2|3.9|< 0.0001
71146410|NCT03175367|141786071|SUPERIORITY||Odds Ratio (OR)|4.8|||=|0.0718|TWO_SIDED|95.0|0.9|26.5|||Regression, Logistic|||||26.5|0.9|= 0.0718
71146411|NCT03175367|141786071|SUPERIORITY||Odds Ratio (OR)|11.4|||=|0.0048|TWO_SIDED|95.0|2.1|62.1|||Regression, Logistic|||||62.1|2.1|= 0.0048
71146412|NCT03175367|141786071|SUPERIORITY||Odds Ratio (OR)|14.7|||=|0.0015|TWO_SIDED|95.0|2.8|76.8|||Regression, Logistic|||||76.8|2.8|= 0.0015
71146413|NCT03175367|141786071|SUPERIORITY||Odds Ratio (OR)|1.7|||=|0.527|TWO_SIDED|95.0|0.3|8.4|||Regression, Logistic|||||8.4|0.3|= 0.5270
71146414|NCT03175367|141786071|SUPERIORITY||Odds Ratio (OR)|7.7|||=|0.0047|TWO_SIDED|95.0|1.9|31.7|||Regression, Logistic|||||31.7|1.9|= 0.0047
71146415|NCT03175367|141786072|SUPERIORITY||Least Squares Mean Difference|-32.5|STANDARD_ERROR_OF_MEAN|11.5|=|0.0059|TWO_SIDED|95.0|-55.5|-9.6|||Mixed Models Analysis|||||-9.6|-55.5|= 0.0059
71146416|NCT03175367|141786072|SUPERIORITY||Least Squares Mean Difference|-54.5|STANDARD_ERROR_OF_MEAN|11.3|<|0.0001|TWO_SIDED|95.0|-77.0|-32.0|||Mixed Models Analysis|||||-32.0|-77.0|< 0.0001
71146417|NCT03175367|141786073|SUPERIORITY||Least Squares Mean Difference|-37.1|STANDARD_ERROR_OF_MEAN|5.7|<|0.0001|TWO_SIDED|95.0|-48.4|-25.8|||Mixed Models Analysis|||||-25.8|-48.4|< .0001
71146418|NCT03175367|141786073|SUPERIORITY||Least Squares Mean Difference|-46.4|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001|TWO_SIDED|95.0|-57.5|-35.2|||Mixed Models Analysis|||||-35.2|-57.5|< .0001
71146419|NCT03175367|141786073|SUPERIORITY||Least Squares Mean Difference|-51.5|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001|TWO_SIDED|95.0|-62.5|-40.4|||Mixed Models Analysis|||||-40.4|-62.5|< .0001
71146420|NCT03175367|141786073|SUPERIORITY||Least Squares Mean Difference|-22.2|STANDARD_ERROR_OF_MEAN|6.2|=|0.0006|TWO_SIDED|95.0|-34.6|-9.8|||Mixed Models Analysis|||||-9.8|-34.6|= 0.0006
71146421|NCT03175367|141786073|SUPERIORITY||Least Squares Mean Difference|-46.4|STANDARD_ERROR_OF_MEAN|6.1|<|0.0001|TWO_SIDED|95.0|-58.4|-34.4|||Mixed Models Analysis|||||-34.4|-58.4|< .0001
71146422|NCT03175367|141786074|SUPERIORITY||Least Squares Mean Difference|-28.4|STANDARD_ERROR_OF_MEAN|7.1|=|0.0001|TWO_SIDED|95.0|-42.6|-14.3|||Mixed Models Analysis|||||-14.3|-42.6|= 0.0001
71146423|NCT03175367|141786074|SUPERIORITY||Least Squares Mean Difference|-49.3|STANDARD_ERROR_OF_MEAN|7.0|<|0.0001|TWO_SIDED|95.0|-63.2|-35.4|||Mixed Models Analysis|||||-35.4|-63.2|< .0001
71146424|NCT03175367|141786075|SUPERIORITY||Adjusted Mean Difference|-46.1|STANDARD_ERROR_OF_MEAN|6.0|<|0.0001|TWO_SIDED|95.0|-57.8|-34.3|||Regression, Linear|||||-34.3|-57.8|< .0001
71146425|NCT03175367|141786075|SUPERIORITY||Adjusted Mean Difference|-55.8|STANDARD_ERROR_OF_MEAN|5.9|<|0.0001|TWO_SIDED|95.0|-67.3|-44.3|||Regression, Linear|||||-44.3|-67.3|< .0001
71146426|NCT03175367|141786075|SUPERIORITY||Adjusted Mean Difference|-61.5|STANDARD_ERROR_OF_MEAN|5.8|<|0.0001|TWO_SIDED|95.0|-72.9|-50.0|||Regression, Linear|||||-50.0|-72.9|< .0001
71146427|NCT03175367|141786075|SUPERIORITY||Adjusted Mean Difference|-25.2|STANDARD_ERROR_OF_MEAN|6.5|=|0.0001|TWO_SIDED|95.0|-38.0|-12.4|||Regression, Linear|||||-12.4|-38.0|= 0.0001
71146428|NCT03175367|141786075|SUPERIORITY||Adjusted Mean Difference|-45.9|STANDARD_ERROR_OF_MEAN|6.3|<|0.0001|TWO_SIDED|95.0|-58.4|-33.5|||Regression, Linear|||||-33.5|-58.4|< .0001
71146429|NCT03175367|141786076|SUPERIORITY||Adjusted Mean Difference|-17.1|STANDARD_ERROR_OF_MEAN|7.5|=|0.0228|TWO_SIDED|95.0|-31.8|-2.4|||Regression, Linear|||||-2.4|-31.8|= 0.0228
71146430|NCT03175367|141786076|SUPERIORITY||Adjusted Mean Difference|-45.3|STANDARD_ERROR_OF_MEAN|7.3|<|0.0001|TWO_SIDED|95.0|-59.6|-31.0|||Regression, Linear|||||-31.0|-59.6|< .0001
71146431|NCT03175367|141786077|SUPERIORITY||Adjusted Mean Difference|-10.6|STANDARD_ERROR_OF_MEAN|5.7|=|0.0635|TWO_SIDED|95.0|-21.8|0.6|||Regression, Linear|||||0.6|-21.8|= 0.0635
71146432|NCT03175367|141786077|SUPERIORITY||Adjusted Mean Difference|-11.9|STANDARD_ERROR_OF_MEAN|5.5|=|0.0314|TWO_SIDED|95.0|-22.8|-1.1|||Regression, Linear|||||-1.1|-22.8|= 0.0314
71146433|NCT03175367|141786077|SUPERIORITY||Adjusted Mean Difference|-9.2|STANDARD_ERROR_OF_MEAN|5.5|=|0.0923|TWO_SIDED|95.0|-19.9|1.5|||Regression, Linear|||||1.5|-19.9|= 0.0923
71146434|NCT03175367|141786077|SUPERIORITY||Adjusted Mean Difference|-16.5|STANDARD_ERROR_OF_MEAN|5.3|=|0.0017|TWO_SIDED|95.0|-26.8|-6.2|||Regression, Linear|||||-6.2|-26.8|= 0.0017
71146435|NCT03175367|141786077|SUPERIORITY||Adjusted Mean Difference|-16.5|STANDARD_ERROR_OF_MEAN|4.9|=|0.0009|TWO_SIDED|95.0|-26.2|-6.8|||Regression, Linear|||||-6.8|-26.2|= 0.0009
71146436|NCT03175367|141786078|SUPERIORITY||Adjusted Mean Difference|-16.1|STANDARD_ERROR_OF_MEAN|5.8|=|0.0054|TWO_SIDED|95.0|-27.4|-4.7|||Regression, Linear|||||-4.7|-27.4|= 0.0054
71146437|NCT03175367|141786078|SUPERIORITY||Adjusted Mean Difference|-14.6|STANDARD_ERROR_OF_MEAN|5.5|=|0.0085|TWO_SIDED|95.0|-25.4|-3.7|||Regression, Linear|||||-3.7|-25.4|= 0.0085
71146438|NCT02151058|141786079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.659|STANDARD_ERROR_OF_MEAN|0.0999|<|0.001|TWO_SIDED|95.0|-0.8559|-0.4622||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.4622|-0.8559|<0.001
71146439|NCT02151058|141786079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.993|STANDARD_ERROR_OF_MEAN|0.1005|<|0.001|TWO_SIDED|95.0|-1.1909|-0.7946||The significance threshold level was 0.05 (two-sided). Hypotheses were tested according to a hierarchical strategy.|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.7946|-1.1909|<0.001
71146440|NCT02151058|141786079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.334|STANDARD_ERROR_OF_MEAN|0.0812|<|0.001|TWO_SIDED|95.0|-0.4937|-0.1737||The significance threshold level was 0.05 (two-sided). Hypotheses were tested according to a hierarchical strategy.|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1737|-0.4937|<0.001
71146441|NCT02151058|141786080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.286|STANDARD_ERROR_OF_MEAN|0.0809|<|0.001|TWO_SIDED|95.0|-0.445|-0.1263||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1263|-0.4450|<0.001
71146442|NCT02151058|141786080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.328|STANDARD_ERROR_OF_MEAN|0.0811|<|0.001|TWO_SIDED|95.0|-0.4877|-0.1679||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1679|-0.4877|<0.001
70955166|NCT01468181|141413795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.51|||<|0.001|TWO_SIDED|95.0|-52.77|-42.24|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-midday meal at 52 Weeks||-42.24|-52.77|<0.001
70955167|NCT01468181|141413795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-67.06|||<|0.001|TWO_SIDED|95.0|-73.02|-61.11|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-midday meal at 26 Weeks||-61.11|-73.02|<0.001
70955168|NCT01468181|141413795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-63.17|||<|0.001|TWO_SIDED|95.0|-69.16|-57.18|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-midday meal at 52 Weeks||-57.18|-69.16|<0.001
70955169|NCT01468181|141413795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.0|||<|0.001|TWO_SIDED|95.0|-49.67|-38.34|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-evening meal at 26 Weeks||-38.34|-49.67|<0.001
70955170|NCT01468181|141413795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.88|||<|0.001|TWO_SIDED|95.0|-49.55|-38.21|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-evening meal at 52 Weeks||-38.21|-49.55|<0.001
70955171|NCT01468181|141413795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-62.91|||<|0.001|TWO_SIDED|95.0|-69.32|-56.5|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-evening meal at 26 Weeks||-56.50|-69.32|<0.001
71146443|NCT02151058|141786080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.0653||0.52|TWO_SIDED|95.0|-0.1709|0.0866||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.0866|-0.1709|0.520
71146444|NCT02151058|141786081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.513|STANDARD_ERROR_OF_MEAN|0.0971|<|0.001|TWO_SIDED|95.0|-0.7043|-0.3217||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.3217|-0.7043|<0.001
71146445|NCT02151058|141786081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.685|STANDARD_ERROR_OF_MEAN|0.0975|<|0.001|TWO_SIDED|95.0|-0.877|-0.4925||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.4925|-0.8770|<0.001
70955172|NCT01468181|141413795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-60.84|||<|0.001|TWO_SIDED|95.0|-66.95|-54.74|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-evening meal at 52 Weeks||-54.74|-66.95|<0.001
71146446|NCT02151058|141786081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.172|STANDARD_ERROR_OF_MEAN|0.0786||0.03|TWO_SIDED|95.0|-0.3268|-0.0168||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0168|-0.3268|0.030
71146447|NCT02151058|141786082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.083|STANDARD_ERROR_OF_MEAN|0.0369||0.026|TWO_SIDED|95.0|-0.1556|-0.0102||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0102|-0.1556|0.026
70874053|NCT03765918|141232860|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-3.03||||0.1364|TWO_SIDED|95.0|-7.03|0.96||Two-sided p-value based on cLDA model.|cLDA model|||||0.96|-7.03|0.1364
70874054|NCT03765918|141232866|SUPERIORITY|Hazard ratio (HR) and associated 95% confidence interval (CI) were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by primary tumor site and tumor stage.|Hazard Ratio (HR)|0.73||||0.00411|TWO_SIDED|95.0|0.58|0.92|||Stratified Log Rank|One-sided p-value was based on log-rank test stratified by primary tumor site and tumor stage.||||0.92|0.58|0.00411
70874055|NCT03765918|141232867|SUPERIORITY|HR and associated 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by primary tumor site and tumor stage.|Hazard Ratio (HR)|0.66||||0.00217|TWO_SIDED|95.0|0.49|0.88|||Stratified Log Rank|One-sided p-value based on log-rank test stratified by primary tumor site and tumor stage.||||0.88|0.49|0.00217
70874056|NCT03765918|141232868|SUPERIORITY|HR and associated 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by primary tumor site and tumor stage.|Hazard Ratio (HR)|0.7||||0.0014|TWO_SIDED|95.0|0.55|0.89|||Stratified Log Rank|One-sided p-value based on log-rank test stratified by primary tumor site and tumor stage.||||0.89|0.55|0.00140
70874057|NCT03250845|141232905|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||H0: No difference between Multigam 5% and Multigam 10% infusion time Ha: Multigam 10% infusion time is significantly shorter than Multigam 5%||||<0.0001
70874058|NCT03250845|141232906|SUPERIORITY||||||<|0.0005|||||||t-test, 1 sided|||H0: No difference in hospitalisation time between Multigam 5% and Multigam 10% infusion Ha: Hospitalisation time with Multigam 10% infusion is significantly shorter than with Multigam 5%||||<0.0005
70874059|NCT03250845|141232908|SUPERIORITY|||||||0.03|||||||t-test, 1 sided|||H0: No difference in number of nursing actions per patient between Multigam 5% and Multigam 10% infusion Ha: Number of nursing actions per patient is smaller with Multigam 10% infusion||||0.03
70874060|NCT04380116|141232921|SUPERIORITY|||||||0.366|||||||ANOVA|||||||.366
70955173|NCT01468181|141413795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-61.15|||<|0.001|TWO_SIDED|95.0|-66.93|-55.37|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Bedtime meal at 26 Weeks||-55.37|-66.93|<0.001
70955174|NCT01468181|141413795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-60.16|||<|0.001|TWO_SIDED|95.0|-66.07|-54.25|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Bedtime meal at 52 Weeks||-54.25|-66.07|<0.001
70955175|NCT01468181|141413796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|||<|0.277|TWO_SIDED|95.0|-0.4|0.12|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Body weight at 26 Weeks||0.12|-0.40|<0.277
70955176|NCT01468181|141413796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.382|TWO_SIDED|95.0|-0.42|0.16|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Body weight at 52 Weeks||0.16|-0.42|0.382
70874061|NCT02408315|141232925|NON_INFERIORITY|Estimates obtained from Kaplan-Meier method and results of Log-rank test. P-value for non-inferiority hypothesis based on Cox proportional hazards model (H0: HR ≤ 0.74 vs. HA: HR \> .74), p-value \< .05 provides evidence to reject inferiority and conclude BM is non-inferior to VM.||||||0.663|||||||Cox proportional|||||||0.663
70874062|NCT01985867|141232937|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.19||||0.399|TWO_SIDED|95.0|0.24|1.5|||risk analysis (prospective)|||||1.5|0.24|0.399
70955177|NCT01468181|141413797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.59|||<|0.001|TWO_SIDED|95.0|26.0|31.18|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HOMA2-B% at 26 Weeks||31.18|26.00|<0.001
70955178|NCT01468181|141413797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.57|||<|0.001|TWO_SIDED|95.0|24.73|30.41|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HOMA2-B% at 52 Weeks||30.41|24.73|<0.001
70955179|NCT01468181|141413797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.57||||0.194|TWO_SIDED|95.0|-6.46|1.32|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HOMA2-S% at 26 Weeks||1.32|-6.46|0.194
70955180|NCT01468181|141413797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.4|TWO_SIDED|65.0|-5.68|2.27|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HOMA2-S% at 52 Weeks||2.27|-5.68|0.400
70955181|NCT00878826|141413798|SUPERIORITY_OR_OTHER|||||||0.4|||||||Kruskal-Wallis|||at 14-18 weeks gestational age||||0.4
70955182|NCT00878826|141413798|SUPERIORITY_OR_OTHER|||||||0.9|||||||Kruskal-Wallis|||at 24-28 weeks gestational age||||0.9
71146448|NCT02151058|141786082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.118|STANDARD_ERROR_OF_MEAN|0.0372||0.002|TWO_SIDED|95.0|-0.1917|-0.0451||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0451|-0.1917|0.002
71146449|NCT02151058|141786082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.035|STANDARD_ERROR_OF_MEAN|0.0297||0.234|TWO_SIDED|95.0|-0.094|0.0231||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.0231|-0.0940|0.234
71146450|NCT02151058|141786083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.176|STANDARD_ERROR_OF_MEAN|0.0568||0.002|TWO_SIDED|95.0|-0.2882|-0.0644||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0644|-0.2882|0.002
71146451|NCT02151058|141786083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.351|STANDARD_ERROR_OF_MEAN|0.0573|<|0.001|TWO_SIDED|95.0|-0.4638|-0.2378||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.2378|-0.4638|<0.001
71146452|NCT02151058|141786083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.174|STANDARD_ERROR_OF_MEAN|0.0458|<|0.001|TWO_SIDED|95.0|-0.2648|-0.0841||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0841|-0.2648|<0.001
70955183|NCT00878826|141413798|SUPERIORITY_OR_OTHER|||||||0.3|||||||Kruskal-Wallis|||at 32-34 weeks gestational age||||0.3
70955184|NCT01200290|141413875|SUPERIORITY_OR_OTHER|||||||0.324|TWO_SIDED|||||P-value is for Week 8.|Mixed Effect Model Repeat Measurement|||||||0.324
70955185|NCT01200290|141413875|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||P-value is for Week 16.|Mixed Effect Model Repeat Measurement|||||||0.031
70955186|NCT01200290|141413875|SUPERIORITY_OR_OTHER|||||||0.076|TWO_SIDED|||||P-value is for Week 24.|Mixed Effect Model Repeat Measurement|||||||0.076
70955187|NCT01200290|141413875|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||P-value is for Week 36.|Mixed Effect Model Repeat Measurement|||||||0.013
70955188|NCT01200290|141413875|SUPERIORITY_OR_OTHER|||||||0.553|TWO_SIDED|||||P-value is for Week 52.|Mixed Effect Model Repeat Measurement|||||||0.553
70955189|NCT01200290|141413875|SUPERIORITY_OR_OTHER|||||||0.132|TWO_SIDED|||||P-value is for Week 64.|Mixed Effect Model Repeat Measurement|||||||0.132
71146453|NCT02151058|141786084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.247|STANDARD_ERROR_OF_MEAN|0.0631|<|0.001|TWO_SIDED|95.0|-0.3713|-0.1226||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||Treatment and baseline value as covariates.||-0.1226|-0.3713|<0.001
71146454|NCT02151058|141786084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.498|STANDARD_ERROR_OF_MEAN|0.0638|<|0.001|TWO_SIDED|95.0|-0.6236|-0.3722||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.3722|-0.6236|<0.001
70955190|NCT01200290|141413875|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|||||P-value is for Week 76.|Mixed Effect Model Repeat Measurement|||||||0.230
70955191|NCT01200290|141413876|SUPERIORITY_OR_OTHER|||||||0.335|TWO_SIDED|||||P-value is for Week 8.|Mixed Effect Model Repeat Measurement|||||||0.335
70955192|NCT01200290|141413876|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED|||||P-value is for Week 16.|Mixed Effect Model Repeat Measurement|||||||0.043
70955193|NCT01200290|141413876|SUPERIORITY_OR_OTHER|||||||0.073|TWO_SIDED|||||P-value is for Week 24.|Mixed Effect Model Repeat Measurement|||||||0.073
70955194|NCT01200290|141413876|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||P-value is for Week 36.|Mixed Effect Model Repeat Measurement|||||||0.004
70955195|NCT01200290|141413876|SUPERIORITY_OR_OTHER|||||||0.699|TWO_SIDED|||||P-value is for Week 52.|Mixed Effect Model Repeat Measurement|||||||0.699
70955196|NCT01200290|141413876|SUPERIORITY_OR_OTHER|||||||0.095|TWO_SIDED|||||P-value is for Week 64.|Mixed Effect Model Repeat Measurement|||||||0.095
70955197|NCT01200290|141413876|SUPERIORITY_OR_OTHER|||||||0.082|TWO_SIDED|||||P-value is for Week 76.|Mixed Effect Model Repeat Measurement|||||||0.082
70955198|NCT00728910|141413883|SUPERIORITY_OR_OTHER||||||>|0.5|TWO_SIDED||||||Mixed Models Analysis|||Null hypothesis was that the sequential addition of a fibrate and niacin to baseline atorvastatin therapy would not have any effect on apo-AI catabolism.||||>0.5
70874063|NCT01985867|141232938|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.2||||0.589|TWO_SIDED|95.0|-0.6|0.7|||Wilcoxon (Mann-Whitney)|||||0.7|-0.6|0.589
70874064|NCT01985867|141232939|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|2.0||||0.005|TWO_SIDED|95.0|0.5|4.0|||Wilcoxon (Mann-Whitney)|||||4.0|0.5|0.005
70955199|NCT00728910|141413884|SUPERIORITY_OR_OTHER||||||>|0.5|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis was that sequential addition of fibrate and niacin to baseline atorvastatin therapy would have no effect on apo-A1 production rates||||>0.5
70874065|NCT01985867|141232940|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.659|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|0.0|0.659
70874066|NCT01985867|141232941|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.79|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|0.0|0.790
70874067|NCT01985867|141232942|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.698|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|0.0|0.698
70874068|NCT01985867|141232943|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.3||||0.12|TWO_SIDED|95.0|0.9|6.2|||risk analysis (prospective)|||||6.2|0.9|0.120
70955200|NCT00728910|141413885|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Mixed Models Analysis|||Null hypothesis was that sequential addition of fibrate and niacin to baseline atorvastatin therapy would have no effect on post-prandial triglyceride levels following an oral fat load||||<0.0005
70874069|NCT01985867|141232944|SUPERIORITY_OR_OTHER_LEGACY|||||||0.116|||||||Wilcoxon (Mann-Whitney)|||||||0.116
70874070|NCT01985867|141232945|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.5||||0.612|TWO_SIDED|95.0|-0.6|0.8|||Wilcoxon (Mann-Whitney)|||||0.8|-0.6|0.612
70874071|NCT01985867|141232946|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.0||||0.004|TWO_SIDED|95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||||2.0|0.0|0.004
70874072|NCT01985867|141232947|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.708|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|0.0|0.708
70955201|NCT00728910|141413885|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0005
70955202|NCT04155203|141413886|EQUIVALENCE|The primary efficacy endpoint was the proportion of subjects in each treatment group with clinical cure, defined as a SIRS score of 0 for all signs and symptoms at Visit 4/Follow-up (7 days after the end of treatment).|equivalence ratio|0.97|||||TWO_SIDED|90.0|-8.19|2.7||||||||2.70|-8.19|
70955203|NCT02489968|141413897|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.97|-0.67|||REML based MMRM|Model including baseline HbA1c, treatment, baseline renal function, prior use of antidiabetic drug, visit, and visit by treatment interaction.|Adjusted mean difference: Change in HbA1c in (empagliflozin 10 mg + linagliptin 5 mg) - change in HbA1c in (empagliflozin 10 mg + placebo)|||-0.67|-0.97|<0.0001
70955204|NCT02489968|141413897|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.73|-0.45|||REML based MMRM|Model including baseline HbA1c, treatment, baseline renal function, prior use of antidiabetic drug, visit, and visit by treatment interaction.|Adjusted mean difference: Change in HbA1c in (empagliflozin 25 mg + linagliptin 5 mg) - change in HbA1c in (empagliflozin 25 mg + placebo)|||-0.45|-0.73|<0.0001
70874073|NCT01985867|141232948|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.522|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||||1.0|-1.0|0.522
70874074|NCT01985867|141232949|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.185|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||||1.0|0.0|0.185
70874075|NCT01985867|141232950|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.973|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|0.0|0.973
70955205|NCT04075994|141413910|SUPERIORITY|||||||0.22||||||A priori threshold for statistical significance p\<0.05.|t-test, 2 sided|||Proportion of days covered assessed as a continuous measure (range 0-1) at 12 months between study arms adjusted for trial stratification factors (type of anticoagulant treatment). We determined that a sample size of 120 in the intervention group and 120 in the control group enables us to detect a minimum difference in PDC as small as 12.6% with 90% power. Power calculations assume use of 2-sided tests with 0.05 significance level.||||0.22
70955206|NCT01141647|141413916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.56|||||TWO_SIDED|90.0|1.8|7.07||||||||7.07|1.80|
70955207|NCT01941719|141413930|EQUIVALENCE|This trial aims to show the enhanced education is no better and no worse than the standard education|Mean Difference (Final Values)|-0.1212||||0.077|TWO_SIDED|||||significance level set at 0.05|ANCOVA|At each follow-up point, multivariate ANCOVA models were used to test for significant changes from the baseline||A mixed-effect model with repeated measures is used to compare the difference of group over time.||||0.0770
70955208|NCT01941719|141413931|EQUIVALENCE|This trial aims to show the new treatment is no better and no worse||||||0.6638||||||The threshold of significance level set at 0.05|Mixed Models Analysis|||||||0.6638
70955209|NCT01941719|141413932|EQUIVALENCE|The test will compare the number of complications between the two groups|||||<|0.05|||||||ANOVA|||||||< 0.05
70955210|NCT01480219|141413933|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.74||||0.042|TWO_SIDED|95.0|1.02|2.96|||Regression, Cox|||Crude hazard ratio (HR) and corresponding 95 percent (%) confidence interval (CI) were calculated using an unadjusted Cox proportional hazards regression model.||2.96|1.02|0.042
70955211|NCT01480219|141413933|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.453|TWO_SIDED|95.0|0.71|2.14|||Regression, Cox|||HR and corresponding 95% CI were calculated using a parsimoniously adjusted Cox proportional hazards regression model.||2.14|0.71|0.453
70955212|NCT01744392|141413935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2||||0.73|TWO_SIDED||||||t-test, 2 sided|||Difference between percentages. Increases in value indicate improvement in adherence.||||.73
70955213|NCT00858364|141413948|NON_INFERIORITY|Non-inferiority was declared if the upper confidence limit for the hazard ratio (darbepoetin alfa to placebo) was less than 1.15 using a 1-sided significance level of 0.025.|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.83|1.01|||||A hazard ratio \< 1.0 indicates a lower risk of death for darbepoetin alfa relative to placebo.|The primary analysis used the Cox Proportional Hazard Model stratified by the randomization stratification factors (geographic region, histology, and screening hemoglobin), with treatment group as the only covariate.||1.01|0.83|
70874076|NCT01985867|141232951|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.642|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|0.0|0.642
71146455|NCT02151058|141786084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.251|STANDARD_ERROR_OF_MEAN|0.0511|<|0.001|TWO_SIDED|95.0|-0.3516|-0.1503||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1503|-0.3516|<0.001
70874077|NCT00555321|141233000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.9|||||TWO_SIDED|95.0|16.1|49.8|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||49.8|16.1|
70874078|NCT00555321|141233000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.6|||||TWO_SIDED|95.0|9.6|43.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||43.5|9.6|
70874079|NCT00555321|141233000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.8|||||TWO_SIDED|95.0|14.8|48.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||48.5|14.8|
70874080|NCT00555321|141233000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|||||TWO_SIDED|95.0|-8.7|29.6|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||29.6|-8.7|
70874081|NCT00555321|141233000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7|||||TWO_SIDED|95.0|-15.3|23.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||23.2|-15.3|
70874082|NCT00555321|141233000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|||||TWO_SIDED|95.0|-9.8|28.4|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||28.4|-9.8|
71146456|NCT02151058|141786085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.124|STANDARD_ERROR_OF_MEAN|0.0372||0.001|TWO_SIDED|95.0|-0.197|-0.0504||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0504|-0.1970|0.001
70874083|NCT00555321|141233001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-12.9|8.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||8.7|-12.9|
70874084|NCT00555321|141233001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|||||TWO_SIDED|95.0|-13.6|8.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||8.5|-13.6|
70874085|NCT00555321|141233001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9|||||TWO_SIDED|95.0|-23.8|1.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||1.5|-23.8|
70874086|NCT00555321|141233001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||95.0|||||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||||
70874087|NCT00555321|141233001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-12.1|11.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||11.3|-12.1|
70874088|NCT00555321|141233001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4|||||TWO_SIDED|95.0|-22.9|4.1|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||4.1|-22.9|
70874089|NCT00555321|141233001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-12.9|8.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||8.7|-12.9|
70874090|NCT00555321|141233001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.1|||||TWO_SIDED|95.0|-18.1|5.4|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||5.4|-18.1|
70874091|NCT00555321|141233001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.1|||||TWO_SIDED|95.0|-38.9|-9.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||-9.5|-38.9|
70874092|NCT00555321|141233001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|||||TWO_SIDED|95.0|-9.9|14.4|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||14.4|-9.9|
70955214|NCT00858364|141413948|NON_INFERIORITY|Non-inferiority was declared if the upper confidence limit for the hazard ratio (darbepoetin alfa to placebo) was less than 1.15 using a 1-sided significance level of 0.025.|Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.83|1.0|||||A hazard ratio \< 1.0 indicates a lower risk of death for darbepoetin alfa relative to placebo.|As a sensitivity analysis, an unstratified Cox Proportional Hazard Model with treatment group as the only covariate was conducted.||1.00|0.83|
71146457|NCT02151058|141786085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.168|STANDARD_ERROR_OF_MEAN|0.0373|<|0.001|TWO_SIDED|95.0|-0.2413|-0.0941||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0941|-0.2413|<0.001
70874093|NCT00555321|141233001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|||||TWO_SIDED|95.0|-15.5|10.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||10.7|-15.5|
70874094|NCT00555321|141233001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.7|||||TWO_SIDED|95.0|-35.5|-4.1|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||-4.1|-35.5|
70874095|NCT00555321|141233002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|-14.5|15.3|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||15.3|-14.5|
70874096|NCT00555321|141233002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.9|||||TWO_SIDED|95.0|-25.7|8.8|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||8.8|-25.7|
70874097|NCT00555321|141233002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7|||||TWO_SIDED|95.0|-13.2|17.5|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||17.5|-13.2|
70874098|NCT00555321|141233002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8|||||TWO_SIDED|95.0|-18.1|13.1|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||13.1|-18.1|
70874099|NCT00555321|141233002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0|||||TWO_SIDED|95.0|-29.4|6.2|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||6.2|-29.4|
70874100|NCT00555321|141233002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-16.9|15.3|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||15.3|-16.9|
70874101|NCT00555321|141233003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.1|||||TWO_SIDED|95.0|15.8|50.6|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||50.6|15.8|
70874102|NCT00555321|141233003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.0|||||TWO_SIDED|95.0|11.4|46.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||46.3|11.4|
70874103|NCT00555321|141233003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.2|||||TWO_SIDED|95.0|16.9|51.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||51.5|16.9|
70874104|NCT00555321|141233003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.0|||||TWO_SIDED|95.0|-7.1|31.6|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||31.6|-7.1|
70874105|NCT00555321|141233003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9|||||TWO_SIDED|95.0|-11.5|27.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||27.2|-11.5|
70874106|NCT00555321|141233003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.1|||||TWO_SIDED|95.0|-5.9|32.6|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||32.6|-5.9|
70874107|NCT00555321|141233004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.6|||||TWO_SIDED|95.0|-5.8|36.8|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||36.8|-5.8|
70874108|NCT00555321|141233004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.0|||||TWO_SIDED|95.0|-6.0|38.0|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||38.0|-6.0|
70874109|NCT00555321|141233004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|||||TWO_SIDED|95.0|-16.6|26.8|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||26.8|-16.6|
70874110|NCT00555321|141233004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.6|||||TWO_SIDED|95.0|-10.8|36.1|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||36.1|-10.8|
70874111|NCT00555321|141233004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.0|||||TWO_SIDED|95.0|-10.9|37.3|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||37.3|-10.9|
70874112|NCT00555321|141233004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0|-21.8|26.0|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||26.0|-21.8|
70874113|NCT00555321|141233028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.1|||||TWO_SIDED|95.0|-6.7|43.3|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||43.3|-6.7|
70874114|NCT00555321|141233028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|||||TWO_SIDED|95.0|-21.6|25.5|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||25.5|-21.6|
70874115|NCT00555321|141233028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8|||||TWO_SIDED|95.0|-20.1|28.7|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||28.7|-20.1|
70874116|NCT00555321|141233028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|||||TWO_SIDED|95.0|-21.2|32.1|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||32.1|-21.2|
70874117|NCT00555321|141233028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6|||||TWO_SIDED|95.0|-36.0|14.2|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||14.2|-36.0|
71146458|NCT02151058|141786085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044|STANDARD_ERROR_OF_MEAN|0.0301||0.145|TWO_SIDED|95.0|-0.1034|0.0152||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.0152|-0.1034|0.145
71146459|NCT02151058|141786086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.0497|<|0.001|TWO_SIDED|95.0|-0.3282|-0.1321||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1321|-0.3282|<0.001
71146460|NCT02151058|141786086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.313|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.4113|-0.2141||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.2141|-0.4113|<0.001
71146461|NCT02151058|141786086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.083|STANDARD_ERROR_OF_MEAN|0.0404||0.042|TWO_SIDED|95.0|-0.1621|-0.0031||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0031|-0.1621|0.042
71146462|NCT02151058|141786087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.275|STANDARD_ERROR_OF_MEAN|0.0543|<|0.001|TWO_SIDED|95.0|-0.382|-0.1679||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1679|-0.3820|<0.001
71146463|NCT02151058|141786087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.464|STANDARD_ERROR_OF_MEAN|0.0548|<|0.001|TWO_SIDED|95.0|-0.5724|-0.3565||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.3565|-0.5724|<0.001
71146464|NCT02151058|141786087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.0442|<|0.001|TWO_SIDED|95.0|-0.2767|-0.1023||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1023|-0.2767|<0.001
71146465|NCT00674817|141786092|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.039|STANDARD_ERROR_OF_MEAN|0.0187|=|0.02|TWO_SIDED|90.0|0.008|0.069|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo' at 1 hour||0.069|0.008|=0.020
71146466|NCT00674817|141786092|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.0227|<|0.001|TWO_SIDED|90.0|0.101|0.176|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 12 hour||0.176|0.101|<0.001
71146467|NCT00674817|141786092|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.0217|<|0.001|TWO_SIDED|90.0|0.087|0.158|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 24 hour||0.158|0.087|<0.001
71146468|NCT00674817|141786092|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.0185|=|0.22|TWO_SIDED|90.0|-0.016|0.045|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 1 hour||0.045|-0.016|=0.220
71146469|NCT00674817|141786092|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.124|STANDARD_ERROR_OF_MEAN|0.0225|<|0.001|TWO_SIDED|90.0|0.087|0.161|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 12 hour||0.161|0.087|<0.001
71146470|NCT00674817|141786092|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.0214|<|0.001|TWO_SIDED|90.0|0.105|0.176|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 24 hour||0.176|0.105|<0.001
71146471|NCT00674817|141786092|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.019|STANDARD_ERROR_OF_MEAN|0.0188||0.155|TWO_SIDED|90.0|-0.012|0.05|||Mix model|||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 1 hour||0.050|-0.012|0.155
71146472|NCT00674817|141786092|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.0229|<|0.001|TWO_SIDED|90.0|0.053|0.129|||Mix model|||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 12 hour||0.129|0.053|<0.001
71146473|NCT00674817|141786092|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.022|<|0.001|TWO_SIDED|90.0|0.09|0.162|||Mix model|||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 24 hour||0.162|0.090|<0.001
71146474|NCT00674817|141786092|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.017|STANDARD_ERROR_OF_MEAN|0.019||0.188|TWO_SIDED|90.0|-0.015|0.048|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 1 hour||0.048|-0.015|0.188
70955215|NCT00858364|141413948|SUPERIORITY|If non-inferiority was demonstrated for both OS and PFS and superiority was demonstrated for the transfusion endpoint, superiority was then tested for both OS and PFS using the Hochberg procedure to adjust for multiplicity.||||||0.07|||||||Stratified log-rank test|Stratified by the randomization stratification factors (geographic region, histology, screening hemoglobin)||||||0.070
70955216|NCT00858364|141413948|SUPERIORITY|||||||0.047|||||||Log Rank|Unstratified log rank test||||||0.047
70955217|NCT00858364|141413948|OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.84|1.02||||||To evaluate the potential effect of cross-in (participants in the placebo group who began treatment with an erythropoiesis-stimulating agent (ESA) at any point after randomization), a sensitivity analysis was conducted that included ESA use as a time-dependent covariate in a Cox regression model stratified by the randomization stratification factors (geographic region, histology, and screening hemoglobin).||1.02|0.84|
70955218|NCT00858364|141413949|NON_INFERIORITY|If non-inferiority was declared for OS, non-inferiority would be declared for PFS if the upper confidence limit for the hazard ratio was less than 1.15 using a 1-sided significance level of 0.025.|Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.87|1.04|||||A hazard ratio \< 1.0 indicates a lower risk of death or progression for darbepoetin alfa relative to placebo.|The primary analysis of PFS used a Cox Proportional Hazard Model stratified by the randomization stratification factors (geographic region, histology, and screening hemoglobin), with treatment group as the only covariate.||1.04|0.87|
70955219|NCT00858364|141413949|NON_INFERIORITY|If non-inferiority was declared for OS, non-inferiority would be declared for PFS if the upper confidence limit for the hazard ratio was less than 1.15 using a 1-sided significance level of 0.025.|Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.87|1.04|||||A hazard ratio \< 1.0 indicates a lower risk of death or progression for darbepoetin alfa relative to placebo.|As a sensitivity analysis, an unstratified Cox Proportional Hazard Model with treatment group as the only covariate was conducted.||1.04|0.87|
70955220|NCT00858364|141413949|SUPERIORITY|If non-inferiority was demonstrated for both OS and PFS and superiority was demonstrated for the transfusion endpoint, superiority was then tested for both OS and PFS using the Hochberg procedure to adjust for multiplicity.||||||0.31|||||||Stratified log-rank test|Stratified by the randomization stratification factors (geographic region, histology, screening hemoglobin).||||||0.31
70955221|NCT00858364|141413949|SUPERIORITY|||||||0.27|||||||Log Rank|Unstratified log rank test||||||0.27
70955222|NCT00858364|141413949|OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.88|1.05||||||To evaluate the potential effect of cross-in (participants in the placebo group who began treatment with an erythropoiesis-stimulating agent (ESA) at any point after randomization), a sensitivity analysis was conducted that included ESA use as a time-dependent covariate in a Cox regression model stratified by the randomization stratification factors (geographic region, histology, and screening hemoglobin).||1.05|0.88|
70955223|NCT00858364|141413950|SUPERIORITY|If non-inferiority was declared for OS and PFS, superiority would be declared for the transfusion endpoint if the p-value from a two-sided test of significance using the Cochran-Mantel-Haenszel method was less than 0.05 in favor of the darbepoetin alfa group.|Odds Ratio (OR)|0.704|||<|0.001|TWO_SIDED|95.0|0.573|0.864|||Cochran-Mantel-Haenszel||An odds ratio \< 1.0 indicates a lower event rate for darbepoetin alfa relative to placebo.|The primary analysis of the incidence of a transfusion or hemoglobin ≤ 8.0 g/dL from day 29 to EOETP was based on the Cochran-Mantel-Haenszel method to test for treatment group differences while adjusting for the randomization stratification factors (geographic region, histology, and screening hemoglobin).||0.864|0.573|< 0.001
70955224|NCT00858364|141413950|OTHER||Odds Ratio (OR)|0.705|||<|0.001|TWO_SIDED|95.0|0.574|0.866|||Regression, Logistic||An odds ratio \< 1.0 indicates a lower event rate for darbepoetin alfa relative to placebo.|As a sensitivity analysis a logistic regression analysis was conducted, stratified by the randomization stratification factors (geographic region, histology, screening hemoglobin).||0.866|0.574|< 0.001
70955225|NCT00858364|141413952|OTHER||Odds Ratio (OR)|1.173||||0.076|TWO_SIDED|95.0|0.983|1.401|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel method adjusted for the randomization stratification factors (geographic region, histology, screening hemoglobin).|An odds ratio \< 1.0 indicates a lower event rate for darbepoetin alfa relative to placebo.|||1.401|0.983|0.076
70955226|NCT00858364|141413952|OTHER||Odds Ratio (OR)|1.173||||0.078|TWO_SIDED|95.0|0.982|1.401|||Cochran-Mantel-Haenszel|Unstratified analysis||||1.401|0.982|0.078
71146475|NCT00674817|141786092|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.055|STANDARD_ERROR_OF_MEAN|0.023|=|0.009|TWO_SIDED|90.0|0.017|0.093|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 12 hour||0.093|0.017|=0.009
71146476|NCT00674817|141786092|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.122|STANDARD_ERROR_OF_MEAN|0.0222|<|0.001|TWO_SIDED|90.0|0.086|0.159|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 24 hour||0.159|0.086|<0.001
71146477|NCT00674817|141786093|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.066|STANDARD_ERROR_OF_MEAN|0.0616|=|0.856|TWO_SIDED|90.0|-0.168|0.036|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 1 hour||0.036|-0.168|=0.856
70955227|NCT00858364|141413954|OTHER||Odds Ratio (OR)|0.741||||0.003|TWO_SIDED|95.0|0.61|0.901|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel method adjusted for the randomization stratification factors (geographic region, histology, screening hemoglobin).|An odds ratio \< 1.0 indicates a lower event rate for darbepoetin alfa relative to placebo.|||0.901|0.610|0.003
70955228|NCT00858364|141413954|OTHER||Odds Ratio (OR)|0.758||||0.003|TWO_SIDED|95.0|0.63|0.913|||Cochran-Mantel-Haenszel|Unstratified analysis||||0.913|0.630|0.003
70955229|NCT03980808|141413956|EQUIVALENCE|A priori significance levels were set to 0.05. As this was a pilot study on a demonstration intervention, power analysis were not performed.|Mean Difference (Net)|1.33|STANDARD_ERROR_OF_MEAN|0.56||0.95|TWO_SIDED||||||ANOVA|Total degrees of freedom (dof) = 17, with between groups dof = 1 and within groups dof = 16.||Composite scores were calculated for the knowledge based tests. Differences in the pre and post test composite scores were compared using ANOVA. We tested the null hypothesis that score changes in the intervention group and control group were the same.||||0.95
70955230|NCT03980808|141413957|EQUIVALENCE|A priori significance levels were set to 0.05. As this was a pilot study on a demonstration intervention, power analysis were not performed.|Mean Difference (Net)|1.03|STANDARD_ERROR_OF_MEAN|0.5376||0.093|TWO_SIDED||||||ANOVA|||Composite scores were calculated for the behavioral self-report tests tests. Differences in the pre and post test composite scores were compared using ANOVA. We tested the null hypothesis that score changes in the intervention group and control group were the same.||||0.093
70955231|NCT01655693|141413958|SUPERIORITY||Hazard Ratio (HR)|1.0|||>|0.991|TWO_SIDED|95.0||||Treatment comparison of DT pooled with BCS used non-stratified Log-rank test at significance level p=0.05.|Log Rank|Log rank test is used after checking the proportional hazards (PH) assumption is valid. The Wilcoxon test is used when the PH assumption fails.|The hazard ratio was controlled for the overall type I error rate at 5% (2-sided) corresponding to 95% confidence interval (CI) and type II error rate as 15%.|Initial 24 month assessment: the primary aim was to demonstrate the superiority of DT pooled (20 mg/m2 and 30 mg/m2) compared to BSC treatment and not individual DT groups per protocol. OS was estimated using the Kaplan-Meier method. The comparison of treatment groups (pooled DT groups versus BSC group) was performed using a non-stratified log-rank test as the primary analysis. The Cox model and Wilcoxon test was used for sensitivity analysis.||||>0.991
70955232|NCT01655693|141413958|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.796|TWO_SIDED|95.0||||Treatment comparison of DT pooled with BCS used non-stratified Log-rank test at significance level p=0.05.|Log Rank|Log rank test is used after checking the proportional hazards (PH) assumption is valid. The Wilcoxon test is used when the PH assumption fails.|The hazard ratio was controlled for the overall type I error rate at 5% (2-sided) corresponding to 95% confidence interval (CI) and type II error rate as 15%.|Follow-up 45 month assessment: the primary aim was to demonstrate the superiority of DT pooled (20 mg/m2 and 30 mg/m2) compared to BSC treatment and not individual DT groups per protocol. OS was estimated using the Kaplan-Meier method. The comparison of treatment groups (pooled DT groups versus BSC group) was performed using a non-stratified log-rank test as the primary analysis. The Cox model and Wilcoxon test was used for sensitivity analysis.||||0.796
71146478|NCT00674817|141786093|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.0496|=|0.033|TWO_SIDED|90.0|0.01|0.174|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 12 hour||0.174|0.010|=0.033
71146479|NCT00674817|141786093|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.0523|=|0.099|TWO_SIDED|90.0|-0.019|0.154|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 24 hour||0.154|-0.019|=0.099
71146480|NCT00674817|141786093|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.067|STANDARD_ERROR_OF_MEAN|0.0612|=|0.862|TWO_SIDED|90.0|-0.168|0.034|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 1 hour||0.034|-0.168|=0.862
71146481|NCT00674817|141786093|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.0493|=|0.008|TWO_SIDED|90.0|0.039|0.201|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 12 hour||0.201|0.039|=0.008
71146482|NCT00674817|141786093|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.0516||0.027|TWO_SIDED|90.0|0.015|0.185|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 24 hour||0.185|0.015|0.027
71146483|NCT00674817|141786093|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.052|STANDARD_ERROR_OF_MEAN|0.0621|=|0.2|TWO_SIDED|90.0|-0.05|0.155|||Mix model|||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 1 hour||0.155|-0.050|=0.200
71146484|NCT00674817|141786093|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.05|=|0.031|TWO_SIDED|90.0|0.011|0.177|||Mix model|||GSK961081 1200 mcg Plus SAL versus that due to GSK961081 1200 mcg plus Placebo at 12 hour||0.177|0.011|=0.031
71146485|NCT00674817|141786093|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.053|=|0.043|TWO_SIDED|90.0|0.004|0.179|||Mix model|||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 24 hour||0.179|0.004|=0.043
71146486|NCT00674817|141786093|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.022|STANDARD_ERROR_OF_MEAN|0.0625|=|0.637|TWO_SIDED|90.0|-0.125|0.081|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 1 hour||0.081|-0.125|=0.637
71146487|NCT00674817|141786093|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.05|=|0.004|TWO_SIDED|90.0|0.053|0.218|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 12 hour||0.218|0.053|=0.004
71146488|NCT00674817|141786093|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.0534|=|0.031|TWO_SIDED|90.0|0.012|0.189|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 24 hour||0.189|0.012|=0.031
71146489|NCT00674817|141786099|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.747|STANDARD_ERROR_OF_MEAN|2.1768|||TWO_SIDED|95.0|-0.547|8.041||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo over 0-4 hours||8.041|-0.547|
71146490|NCT00674817|141786099|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.712|STANDARD_ERROR_OF_MEAN|2.1453|||TWO_SIDED|95.0|-2.521|5.944||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo over 0-4 hours||5.944|-2.521|
71146491|NCT00674817|141786099|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.755|STANDARD_ERROR_OF_MEAN|2.1869|||TWO_SIDED|95.0|-2.559|6.069||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo over 0-4 hours||6.069|-2.559|
71146492|NCT00674817|141786099|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.231|STANDARD_ERROR_OF_MEAN|2.197|||TWO_SIDED|95.0|-5.565|3.103||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo over 0-4 hours||3.103|-5.565|
71146493|NCT00674817|141786100|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.558|STANDARD_ERROR_OF_MEAN|2.7064|||TWO_SIDED|95.0|-0.781|9.897||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo over 0-27 hours||9.897|-0.781|
71146494|NCT00674817|141786100|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.266|STANDARD_ERROR_OF_MEAN|2.6691|||TWO_SIDED|95.0|-2.999|7.532||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo over 0-27 hours||7.532|-2.999|
71146495|NCT00674817|141786100|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|2.717|||TWO_SIDED|95.0|-4.429|6.29||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo over 0-27 hours||6.290|-4.429|
71146496|NCT00674817|141786100|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.152|STANDARD_ERROR_OF_MEAN|2.731|||TWO_SIDED|95.0|-6.539|4.236||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo over 0-27 hours||4.236|-6.539|
71146497|NCT00674817|141786101|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.249|STANDARD_ERROR_OF_MEAN|1.6816|||TWO_SIDED|95.0|-2.069|4.566||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo over 0-4 hours||4.566|-2.069|
71146498|NCT00674817|141786101|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.418|STANDARD_ERROR_OF_MEAN|1.6565|||TWO_SIDED|95.0|-2.85|3.687||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo over 0-4 hours||3.687|-2.850|
71146499|NCT00674817|141786101|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|1.705|||TWO_SIDED|95.0|-4.013|2.714||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo over 0-4 hours||2.714|-4.013|
71146500|NCT00674817|141786101|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.949|STANDARD_ERROR_OF_MEAN|1.7112|||TWO_SIDED|95.0|-5.325|1.427||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo over 0-4 hours||1.427|-5.325|
71146501|NCT00674817|141786102|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.198|STANDARD_ERROR_OF_MEAN|2.5039|||TWO_SIDED|95.0|5.258|15.139||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||15.139|5.258|
71146502|NCT00674817|141786102|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.686|STANDARD_ERROR_OF_MEAN|2.4738|||TWO_SIDED|95.0|-2.195|7.567||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||7.567|-2.195|
71146503|NCT00674817|141786102|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.854|STANDARD_ERROR_OF_MEAN|2.5196|||TWO_SIDED|95.0|2.883|12.825||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||12.825|2.883|
71146504|NCT00674817|141786102|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.884|STANDARD_ERROR_OF_MEAN|2.5244|||TWO_SIDED|95.0|-5.864|4.097||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||4.097|-5.864|
71146505|NCT00674817|141786102|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.227|STANDARD_ERROR_OF_MEAN|2.9782|||TWO_SIDED|95.0|5.352|17.103||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours||17.103|5.352|
71146506|NCT00674817|141786102|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.39|STANDARD_ERROR_OF_MEAN|2.9434|||TWO_SIDED|95.0|-1.418|10.197||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours||10.197|-1.418|
71146507|NCT00674817|141786102|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.975|STANDARD_ERROR_OF_MEAN|2.9958|||TWO_SIDED|95.0|0.065|11.886||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours||11.886|0.065|
71146508|NCT00674817|141786102|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.083|STANDARD_ERROR_OF_MEAN|3.0023|||TWO_SIDED|95.0|-8.006|3.84||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours||3.840|-8.006|
71146509|NCT00674817|141786103|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|1.6941|||TWO_SIDED|95.0|1.857|8.542||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||8.542|1.857|
71146510|NCT00674817|141786103|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|1.6727|||TWO_SIDED|95.0|-3.294|3.307||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||3.307|-3.294|
71146511|NCT00674817|141786103|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.956|STANDARD_ERROR_OF_MEAN|1.7178|||TWO_SIDED|95.0|-0.433|6.345||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||6.345|-0.433|
71146512|NCT00674817|141786103|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.683|STANDARD_ERROR_OF_MEAN|1.7199|||TWO_SIDED|95.0|-5.076|1.711||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||1.711|-5.076|
71146513|NCT00674817|141786104|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.588|STANDARD_ERROR_OF_MEAN|1.3932|||TWO_SIDED|95.0|3.839|9.336||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||9.336|3.839|
71146514|NCT00674817|141786104|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.255|STANDARD_ERROR_OF_MEAN|1.3725|||TWO_SIDED|95.0|-1.453|3.962||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||3.962|-1.453|
71146515|NCT00674817|141786104|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.985|STANDARD_ERROR_OF_MEAN|1.396|||TWO_SIDED|95.0|4.231|9.738||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||9.738|4.231|
71146516|NCT00674817|141786104|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.255|STANDARD_ERROR_OF_MEAN|1.4077|||TWO_SIDED|95.0|-0.522|5.031||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||5.031|-0.522|
71146517|NCT00674817|141786104|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.121|STANDARD_ERROR_OF_MEAN|1.2464|||TWO_SIDED|95.0|1.662|6.58||||||GSK961081 400 mcg Plus SAL versus maximal GSK961081 400 mcg plus Placebo during 0-27 hours||6.580|1.662|
71146518|NCT00674817|141786104|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|1.2278|||TWO_SIDED|95.0|-2.142|2.703||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours||2.703|-2.142|
71146519|NCT00674817|141786104|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.266|STANDARD_ERROR_OF_MEAN|1.249|||TWO_SIDED|95.0|1.802|6.729||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours||6.729|1.802|
71146520|NCT00674817|141786104|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.621|STANDARD_ERROR_OF_MEAN|1.2593|||TWO_SIDED|95.0|-0.863|4.106||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours||4.106|-0.863|
71146521|NCT00674817|141786105|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.094|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|95.0|2.456|5.732||||||GSK961081 400 mcg plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||5.732|2.456|
71146522|NCT00674817|141786105|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.646|STANDARD_ERROR_OF_MEAN|0.8172|||TWO_SIDED|95.0|-0.967|2.258||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||2.258|-0.967|
71146523|NCT00674817|141786105|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.98|STANDARD_ERROR_OF_MEAN|0.8395|||TWO_SIDED|95.0|2.324|5.636||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||5.636|2.324|
71146524|NCT00674817|141786105|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.934|STANDARD_ERROR_OF_MEAN|0.846|||TWO_SIDED|95.0|-0.735|2.603||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||2.603|-0.735|
71146525|NCT00674817|141786106|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.836|STANDARD_ERROR_OF_MEAN|1.8168|||TWO_SIDED|95.0|-5.42|1.748||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||1.748|-5.420|
71146526|NCT00674817|141786106|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.599|STANDARD_ERROR_OF_MEAN|1.7809|||TWO_SIDED|95.0|-2.914|4.113||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||4.113|-2.914|
71146527|NCT00674817|141786106|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.324|STANDARD_ERROR_OF_MEAN|1.8174|||TWO_SIDED|95.0|-3.261|3.909||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||3.909|-3.261|
71146528|NCT00674817|141786106|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.182|STANDARD_ERROR_OF_MEAN|1.8242|||TWO_SIDED|95.0|-5.781|1.416||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||1.416|-5.781|
71146529|NCT00674817|141786106|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.266|STANDARD_ERROR_OF_MEAN|1.7723|||TWO_SIDED|95.0|-6.762|0.23||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours||0.230|-6.762|
71146530|NCT00674817|141786106|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.077|STANDARD_ERROR_OF_MEAN|1.7361|||TWO_SIDED|95.0|-3.502|3.348||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours||3.348|-3.502|
71146531|NCT00674817|141786106|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.827|STANDARD_ERROR_OF_MEAN|1.7743|||TWO_SIDED|95.0|-1.673|5.327||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours||5.327|-1.673|
71146532|NCT00674817|141786106|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.232|STANDARD_ERROR_OF_MEAN|1.78|||TWO_SIDED|95.0|-4.743|2.279||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours||2.279|-4.743|
71146533|NCT00674817|141786106|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.394|STANDARD_ERROR_OF_MEAN|1.3084|||TWO_SIDED|95.0|-3.976|1.187||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||1.187|-3.976|
71146534|NCT00674817|141786106|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.181|STANDARD_ERROR_OF_MEAN|1.2819|||TWO_SIDED|95.0|-1.348|3.71||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||3.710|-1.348|
71146535|NCT00674817|141786106|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|1.3201|||TWO_SIDED|95.0|-2.498|2.71||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||2.710|-2.498|
71146536|NCT00674817|141786106|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.713|STANDARD_ERROR_OF_MEAN|1.3241|||TWO_SIDED|95.0|-3.325|1.899||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||1.899|-3.325|
70955233|NCT01655693|141413959|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.7|TWO_SIDED|95.0||||Treatment comparison with BCS using non-stratified Log-rank test at significance level p=0.05.|Log Rank||Hazard ratio for treatment variable was determined by Cox model. The hazard ratio was controlled for the overall type I error rate at 5% (2-sided) and type II error rate as 15%.|PFS was estimated using Kaplan-Meier methods and plotted as curves by treatment group. For comparison between treatment groups (pooled DT 20 mg/m2 and 30 mg/m2 versus BSC) used Log-rank test as primary analysis. Hazard ratio, mean, and mean PFS rate were given with corresponding 95% CI.||||0.7
70955234|NCT01655693|141413960|SUPERIORITY|||||||1||||||Treatment comparison with BCS using Fisher's exact test at significance level p=0.05.|Fisher Exact|||The comparisons between groups (pooled DT 20 mg/m2 and 30mg/m2 versus BSC) used Fisher's exact test.||||1.0
70955235|NCT02285153|141414040|SUPERIORITY||Cox Proportional Hazard|0.434|STANDARD_ERROR_OF_MEAN|1.225||0.57|TWO_SIDED|95.0|0.039|4.792||Due to the low number of participants, the results of the statistical tests must be interpreted with caution!|Chi-squared|||||4.792|0.039|0.57
71146537|NCT00674817|141786107|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.561|STANDARD_ERROR_OF_MEAN|1.2351|||TWO_SIDED|95.0|-2.997|1.876||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||1.876|-2.997|
71146538|NCT00674817|141786107|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.705|STANDARD_ERROR_OF_MEAN|1.2125|||TWO_SIDED|95.0|-0.687|4.097||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||4.097|-0.687|
71146539|NCT00674817|141786107|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.337|STANDARD_ERROR_OF_MEAN|1.2341|||TWO_SIDED|95.0|-3.771|1.098||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||1.098|-3.771|
71146540|NCT00674817|141786107|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.067|STANDARD_ERROR_OF_MEAN|1.2416|||TWO_SIDED|95.0|-3.516|1.382||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||1.382|-3.516|
71146541|NCT00674817|141786107|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.376|STANDARD_ERROR_OF_MEAN|1.0997|||TWO_SIDED|95.0|-2.545|1.794||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours||1.794|-2.545|
71146542|NCT00674817|141786107|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|1.0786|||TWO_SIDED|95.0|-1.588|2.668||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours||2.668|-1.588|
71146543|NCT00674817|141786107|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.016|STANDARD_ERROR_OF_MEAN|1.0999|||TWO_SIDED|95.0|-2.185|2.154||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours||2.154|-2.185|
71146544|NCT00674817|141786107|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.466|STANDARD_ERROR_OF_MEAN|1.1058|||TWO_SIDED|95.0|-1.715|2.648||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours||2.648|-1.715|
71146545|NCT00674817|141786107|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.18|STANDARD_ERROR_OF_MEAN|0.881|||TWO_SIDED|95.0|-2.918|0.559||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||0.559|-2.918|
71146546|NCT00674817|141786107|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.876|STANDARD_ERROR_OF_MEAN|0.8644|||TWO_SIDED|95.0|-0.829|2.582||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||2.582|-0.829|
71146547|NCT00674817|141786107|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.809|STANDARD_ERROR_OF_MEAN|0.8882|||TWO_SIDED|95.0|-2.561|0.944||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||0.944|-2.561|
70955236|NCT02285153|141414041|SUPERIORITY|||||||0.057|||||||Chi-squared|||||||0.057
70955237|NCT02285153|141414042|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
71146548|NCT00674817|141786107|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.8929|||TWO_SIDED|95.0|-2.122|1.401||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||1.401|-2.122|
71146549|NCT00674817|141786108|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|0.2352|||TWO_SIDED|95.0|0.066|0.994||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||0.994|0.066|
71146550|NCT00674817|141786108|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.388|STANDARD_ERROR_OF_MEAN|0.2318|||TWO_SIDED|95.0|-0.069|0.846||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||0.846|-0.069|
71146551|NCT00674817|141786108|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.309|STANDARD_ERROR_OF_MEAN|0.2363|||TWO_SIDED|95.0|-0.157|0.775||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||0.775|-0.157|
71146552|NCT00674817|141786108|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.309|STANDARD_ERROR_OF_MEAN|0.2392|||TWO_SIDED|95.0|-0.163|0.78||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||0.780|-0.163|
71146553|NCT00674817|141786108|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.874|STANDARD_ERROR_OF_MEAN|0.3099|||TWO_SIDED|95.0|0.262|1.485||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours||1.485|0.262|
71146554|NCT00674817|141786108|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.3056|||TWO_SIDED|95.0|-0.656|0.55||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours||0.550|-0.656|
71146555|NCT00674817|141786108|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.829|STANDARD_ERROR_OF_MEAN|0.3112|||TWO_SIDED|95.0|0.215|1.443||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours||1.443|0.215|
71146556|NCT00674817|141786108|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.567|STANDARD_ERROR_OF_MEAN|0.3151|||TWO_SIDED|95.0|-0.054|1.189||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours||1.189|-0.054|
71146557|NCT00674817|141786108|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.312|STANDARD_ERROR_OF_MEAN|0.1021|||TWO_SIDED|95.0|0.11|0.513||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||0.513|0.110|
71146558|NCT00674817|141786108|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.1006|||TWO_SIDED|95.0|-0.025|0.372||||||GSK961081 400 mcg Plus IPR versus maximum GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||0.372|-0.025|
71146559|NCT00674817|141786108|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.1035|||TWO_SIDED|95.0|0.006|0.414||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||0.414|0.006|
70955238|NCT02285153|141414043|SUPERIORITY|||||||0.467|||||||Chi-squared|||||||0.467
70955239|NCT01472549|141414067|SUPERIORITY||Risk Ratio (RR)|0.55||||0.02|TWO_SIDED|95.0|0.34|0.9|||Chi-squared|||||0.90|0.34|0.02
71146560|NCT00674817|141786108|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.1047|||TWO_SIDED|95.0|-0.103|0.311||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||0.311|-0.103|
71146561|NCT00674817|141786109|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.177|STANDARD_ERROR_OF_MEAN|0.0503|||TWO_SIDED|95.0|-0.276|-0.078||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||-0.078|-0.276|
71146562|NCT00674817|141786109|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.049|||TWO_SIDED|95.0|-0.096|0.097||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||0.097|-0.096|
71146563|NCT00674817|141786109|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.076|STANDARD_ERROR_OF_MEAN|0.0498|||TWO_SIDED|95.0|-0.174|0.022||||||SK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||0.022|-0.174|
71146564|NCT00674817|141786109|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.028|STANDARD_ERROR_OF_MEAN|0.0507|||TWO_SIDED|95.0|-0.128|0.072||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||0.072|-0.128|
70955240|NCT01472549|141414068|SUPERIORITY|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
70955241|NCT01472549|141414069|SUPERIORITY||Risk Ratio (RR)|0.76||||0.37|TWO_SIDED|95.0|0.43|1.37|||Chi-squared|||||1.37|0.43|0.37
70955242|NCT01472549|141414070|SUPERIORITY||Risk Ratio (RR)|0.73||||0.49|TWO_SIDED|95.0|0.3|1.8|||Chi-squared|||||1.80|0.30|0.49
70955243|NCT01472549|141414071|SUPERIORITY|||||||0.08|||||||Fisher Exact|||||||0.08
70955244|NCT01472549|141414072|SUPERIORITY||Risk Ratio (RR)|2.02||||0.56|TWO_SIDED|95.0|0.18|22.11|||Fisher Exact|||||22.11|0.18|0.56
70955245|NCT01489891|141414080|NON_INFERIORITY_OR_EQUIVALENCE|Beta 0.1; Alpha 0.05|Median Difference (Final Values)|30.6|STANDARD_DEVIATION|42.1|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.05
70955246|NCT03001076|141414084|SUPERIORITY||Difference in LS mean|-28.45|STANDARD_ERROR_OF_MEAN|3.022|<|0.001|TWO_SIDED|95.0|-34.376|-22.531|||ANCOVA|||||-22.531|-34.376|<0.001
71146565|NCT00674817|141786109|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.166|STANDARD_ERROR_OF_MEAN|0.0493|||TWO_SIDED|95.0|-0.263|-0.069||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours||-0.069|-0.263|
70874118|NCT00555321|141233028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.5|||||TWO_SIDED|95.0|-34.6|17.3|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||17.3|-34.6|
70955247|NCT03001076|141414085|SUPERIORITY||Difference in LS mean|-23.56|STANDARD_ERROR_OF_MEAN|2.777|<|0.001|TWO_SIDED|95.0|-29.005|-18.121|||ANCOVA|||||-18.121|-29.005|<0.001
70955248|NCT03001076|141414086|SUPERIORITY||Difference in LS mean|-17.99|STANDARD_ERROR_OF_MEAN|2.018|<|0.001|TWO_SIDED|95.0|-21.94|-14.03|||ANCOVA|||||-14.030|-21.940|<0.001
71146566|NCT00674817|141786109|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.057|STANDARD_ERROR_OF_MEAN|0.0481|||TWO_SIDED|95.0|-0.152|0.038||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours||0.038|-0.152|
71146567|NCT00674817|141786109|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.171|STANDARD_ERROR_OF_MEAN|0.0489|||TWO_SIDED|95.0|-0.267|-0.075||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours||-0.075|-0.267|
71146568|NCT00674817|141786109|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.009|STANDARD_ERROR_OF_MEAN|0.0498|||TWO_SIDED|95.0|-0.108|0.089||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours||0.089|-0.108|
71146569|NCT00674817|141786109|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.108|STANDARD_ERROR_OF_MEAN|0.0522|||TWO_SIDED|95.0|-0.211|-0.005||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||-0.005|-0.211|
71146570|NCT00674817|141786109|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.0509|||TWO_SIDED|95.0|-0.087|0.114||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||0.114|-0.087|
71146571|NCT00674817|141786109|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.077|STANDARD_ERROR_OF_MEAN|0.052|||TWO_SIDED|95.0|-0.18|0.026||||||GSK961081 1200 mcg Plus SAL GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||0.026|-0.180|
71146572|NCT00674817|141786109|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|0.0529|||TWO_SIDED|95.0|-0.129|0.08||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||0.080|-0.129|
71146573|NCT03199976|141786122|SUPERIORITY||||||<|0.01||||||Bonferroni correction was applied in pairwise analyses.|Wilcoxon (Mann-Whitney)|||||||<0.01
71146574|NCT03199976|141786123|SUPERIORITY|||||||0.595|||||||Chi-squared|||||||0.595
70955249|NCT03001076|141414087|SUPERIORITY||Difference in LS mean|-19.32|STANDARD_ERROR_OF_MEAN|2.341|<|0.001|TWO_SIDED|95.0|-23.908|-14.732|||ANCOVA|||||-14.732|-23.908|<0.001
70955250|NCT03001076|141414088|SUPERIORITY||Location shift|-31.045|||<|0.001|TWO_SIDED|95.0|-44.761|-17.401|||Wilcoxon Rank Sum Test||The location shift and asymptotic 95% confidence interval are based on Hodges-Lehman estimation.|||-17.401|-44.761|<0.001
70955251|NCT03001076|141414089|SUPERIORITY||Difference in LS mean|-4.53|STANDARD_ERROR_OF_MEAN|5.24|=|0.388|TWO_SIDED|95.0|-14.877|5.812|||ANCOVA|||||5.812|-14.877|=0.388
70955252|NCT03001076|141414090|SUPERIORITY||Difference in LS mean|-5.89|STANDARD_ERROR_OF_MEAN|1.845|=|0.002|TWO_SIDED|95.0|-9.528|-2.25|||ANCOVA|||||-2.250|-9.528|=0.002
70955253|NCT03001076|141414092|SUPERIORITY||Difference in LS mean|-31.09|STANDARD_ERROR_OF_MEAN|2.238|<|0.001|TWO_SIDED|95.0|-35.498|-26.682|||ANCOVA|||Change from Baseline to Week 4||-26.682|-35.498|<0.001
70955254|NCT03001076|141414092|SUPERIORITY||Difference in LS mean|-29.12|STANDARD_ERROR_OF_MEAN|2.513|<|0.001|TWO_SIDED|95.0|-34.074|-24.168|||ANCOVA|||Change from Baseline to Week 8||-24.168|-34.074|<0.001
70955255|NCT03001076|141414093|SUPERIORITY||Difference in LS mean|-25.26|STANDARD_ERROR_OF_MEAN|2.004|<|0.001|TWO_SIDED|95.0|-29.204|-21.308|||ANCOVA|||Change from Baseline to Week 4||-21.308|-29.204|<0.001
70955256|NCT03001076|141414093|SUPERIORITY||Difference in LS mean|-23.75|STANDARD_ERROR_OF_MEAN|2.268|<|0.001|TWO_SIDED|95.0|-28.219|-19.276|||ANCOVA|||Change from Baseline to Week 8||-19.276|-28.219|<0.001
70955257|NCT03001076|141414094|SUPERIORITY||Difference in LS mean|-20.41|STANDARD_ERROR_OF_MEAN|1.513|<|0.001|TWO_SIDED|95.0|-23.39|-17.43|||ANCOVA|||Change from Baseline to Week 4||-17.430|-23.390|<0.001
71146575|NCT03199976|141786124|SUPERIORITY||||||<|0.01||||||Bonferroni correction was applied in pairwise analyses.|Wilcoxon (Mann-Whitney)|||||||<0.01
70874119|NCT00555321|141233028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|||||TWO_SIDED|95.0|-18.8|35.1|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||35.1|-18.8|
70874120|NCT00555321|141233028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.6|||||TWO_SIDED|95.0|-46.3|6.3|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||6.3|-46.3|
70874121|NCT00555321|141233028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.4|||||TWO_SIDED|95.0|-48.2|5.2|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||5.2|-48.2|
70874122|NCT00555321|141233028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.4|||||TWO_SIDED|95.0|-5.2|48.4|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||48.4|-5.2|
70874123|NCT00555321|141233028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.1|||||TWO_SIDED|95.0|-32.9|19.8|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||19.8|-32.9|
70874124|NCT00555321|141233028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.9|||||TWO_SIDED|95.0|-34.8|18.7|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||18.7|-34.8|
70874125|NCT00555321|141233029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.8|||||TWO_SIDED|95.0|-42.4|26.3|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12||26.3|-42.4|
70874126|NCT00555321|141233029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.2|||||TWO_SIDED|95.0|-49.2|19.0|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12||19.0|-49.2|
70874127|NCT00555321|141233029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-58.8|||||TWO_SIDED|95.0|-81.6|-19.8|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12||-19.8|-81.6|
70874128|NCT00555321|141233029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.7|||||TWO_SIDED|95.0|-55.9|16.9|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12||16.9|-55.9|
70874129|NCT00555321|141233029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.1|||||TWO_SIDED|95.0|-62.6|9.4|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12||9.4|-62.6|
70874130|NCT00555321|141233029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-72.7|||||TWO_SIDED|95.0|-94.0|-33.1|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12||-33.1|-94.0|
71146576|NCT03199976|141786125|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
70874131|NCT00555321|141233029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|||||TWO_SIDED|95.0|-32.6|34.3|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock||34.3|-32.6|
70874132|NCT00555321|141233029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.7|||||TWO_SIDED|95.0|-47.4|20.6|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock||20.6|-47.4|
70874133|NCT00555321|141233029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.5|||||TWO_SIDED|95.0|-72.6|0.5|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock||0.5|-72.6|
70874134|NCT00555321|141233029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1|||||TWO_SIDED|95.0|-41.1|31.1|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock||31.1|-41.1|
70874135|NCT00555321|141233029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.7|||||TWO_SIDED|95.0|-55.9|16.9|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock||16.9|-55.9|
70874136|NCT00555321|141233029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.5|||||TWO_SIDED|95.0|-81.9|-3.5|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock||-3.5|-81.9|
70874137|NCT00555321|141233042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|||||TWO_SIDED|95.0|-21.2|6.0|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||6.0|-21.2|
70874138|NCT00555321|141233042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||||TWO_SIDED|95.0|-18.2|5.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||5.3|-18.2|
70874139|NCT00555321|141233042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|||||TWO_SIDED|95.0|-14.9|4.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||4.5|-14.9|
70874140|NCT00555321|141233042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|||||TWO_SIDED|95.0|-25.1|7.1|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||7.1|-25.1|
70955258|NCT03001076|141414094|SUPERIORITY||Difference in LS mean|-18.46|STANDARD_ERROR_OF_MEAN|1.651|<|0.001|TWO_SIDED|95.0|-21.71|-15.206|||ANCOVA|||Change from Baseline to Week 8||-15.206|-21.710|<0.001
70955259|NCT03001076|141414095|SUPERIORITY||Difference in LS mean|-0.8|STANDARD_ERROR_OF_MEAN|4.99|=|0.873|TWO_SIDED|95.0|-10.663|9.059|||ANCOVA|||Change from Baseline to Week 4||9.059|-10.663|=0.873
70955260|NCT03001076|141414095|SUPERIORITY||Difference in LS mean|-0.08|STANDARD_ERROR_OF_MEAN|5.131|=|0.988|TWO_SIDED|95.0|-10.215|10.055|||ANCOVA|||Change from Baseline to Week 8||10.055|-10.215|=0.988
70955261|NCT03001076|141414096|SUPERIORITY||Difference in LS mean|-8.59|STANDARD_ERROR_OF_MEAN|1.619|<|0.001|TWO_SIDED|95.0|-11.778|-5.394|||ANCOVA|||Change from Baseline to Week 4||-5.394|-11.778|<0.001
70955262|NCT03001076|141414096|SUPERIORITY||Difference in LS mean|-6.42|STANDARD_ERROR_OF_MEAN|1.712|<|0.001|TWO_SIDED|95.0|-9.798|-3.049|||ANCOVA|||Change from Baseline to Week 8||-3.049|-9.798|<0.001
70955263|NCT03592745|141414126|EQUIVALENCE|Statistical analysis of the median absolute change in bicep peak sEMG amplitude from baseline to DC immediately following 3 weeks of training was measured in the active vs. sham tVNS conditions. Null hypothesis is that there is no difference in median absolute change in bicep peak sEMG amplitude between the active and sham tVNS conditions. A significance level of 0.05 was used (two-tailed).|U value|32.0||||0.002|TWO_SIDED|||||The Mann-Whitney Wilcoxon test was performed to compare median absolute change in bicep peak sEMG amplitude from baseline to 3 weeks (discharge) across two separate study conditions (active vs. sham tVNS).|Wilcoxon (Mann-Whitney)|||||||0.002
71146577|NCT01780506|141786135|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: the E/C/F/TAF group was ≥ 12% worse than the E/C/F/TDF group with respect to the percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48; alternative hypothesis: the E/C/F/TAF group was \< 12% worse than the E/C/F/TDF group.|Difference in percentages|0.5||||0.78|TWO_SIDED|95.002|-3.0|4.0||P-value was from the Cochran-Mantel-Haenszel (CMH) test stratified by baseline HIV-1 RNA (≤ 100,000 or \> 100,000 copies/mL) and region (US vs ex-US).|Cochran-Mantel-Haenszel||The difference in percentages and its 95.002% confidence interval (CI) were calculated based on the Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA and region stratum.|||4.0|-3.0|0.78
71146578|NCT00412984|141786200|SUPERIORITY|With an average 2.1 years follow-up and assuming a stroke rate of 1.20 per hundred patient-years, \~18,000 randomized subjects allocated in a 1:1 ratio to apixaban or warfarin group would be needed to achieve the desired power. These calculations assumed an incidence of 1% loss to follow-up. Non-inferiority for the primary efficacy endpoint will be assessed first. If non-inferiority (using a NI margin of 1.38) is demonstrated then, superiority for the primary efficacy endpoint will be tested|Hazard Ratio (HR)|0.79||||0.0114|TWO_SIDED|95.0|0.66|0.95||2-sided P-value for superiority test|Cox Proportional Hazards Model|Model included treatment group as a covariate; stratified by investigative site and prior warfarin/vitamin K antagonist status. (experienced, naïve).|apixaban / warfarin|With 448 subjects with confirmed strokes or systemic emboli, study would have at least 90% power to meet both regulatory definitions of non-inferiority described in the following: (1) the non-inferiority (NI) of apixaban relative to warfarin was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for relative risk (RR) was less than 1.38; (2) the NI of apixaban relative to warfarin was demonstrated if the upper bound of the two-sided 99% CI for RR was less than 1.44.||.95|.66|0.0114
70955264|NCT03592745|141414126|EQUIVALENCE|Statistical analysis of the median absolute change in tricep peak sEMG amplitude from baseline to DC immediately following 3 weeks of training was measured in the active vs. sham tVNS conditions. Null hypothesis is that there is no difference in median absolute change in bicep peak sEMG amplitude between the active and sham tVNS conditions. A significance level of 0.05 was used (two-tailed).|U value|87.0||||0.445|TWO_SIDED|||||The Mann-Whitney Wilcoxon test was performed to compare median absolute change in tricep peak sEMG amplitude from baseline to 3 weeks (discharge) across two separate study conditions (active vs. sham tVNS).|Wilcoxon (Mann-Whitney)|||||||0.445
70955265|NCT03592745|141414126|EQUIVALENCE|Statistical analysis of the median absolute change in bicep peak sEMG amplitude from baseline to week 16 (3 month follow-up after training) was measured in the active vs. sham tVNS conditions. Null hypothesis is that there is no difference in median absolute change in bicep peak sEMG amplitude between the active and sham tVNS conditions. A significance level of 0.05 was used (two-tailed).|U value|95.0||||0.678|TWO_SIDED|||||The Mann-Whitney Wilcoxon test was performed to compare the median absolute change in bicep peak sEMG from baseline to 16 weeks (follow-up) across two separate study conditions (active vs. sham tVNS).|Wilcoxon (Mann-Whitney)|||||||0.678
70955266|NCT03592745|141414126|EQUIVALENCE|Statistical analysis of the median absolute change in tricep peak sEMG amplitude from baseline to week 16 (3 month follow-up after training) was measured in the active vs. sham tVNS conditions. Null hypothesis is that there is no difference in median absolute change in bicep peak sEMG amplitude between the active and sham tVNS conditions. A significance level of 0.05 was used (two-tailed).|U value|98.0||||0.777|TWO_SIDED|||||The Mann-Whitney Wilcoxon test was performed to compare the median absolute change in tricep peak sEMG from baseline to 16 weeks (follow-up) across two separate study conditions (active vs. sham tVNS).|Wilcoxon (Mann-Whitney)|||||||0.777
70955267|NCT03592745|141414127|EQUIVALENCE|Statistical analysis of median change from baseline to DC immediately following 3 weeks of training was assessed with the upper extremity fugl meyer score in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in upper extremity fugl meyer score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|112.0||||1|TWO_SIDED|||||The Mann-Whitney Wilcoxon test was performed to compare median change in Upper Extremity Fugl Meyer score from baseline to 3 weeks (discharge) across two separate study conditions (active vs. sham tVNS).|Wilcoxon (Mann-Whitney)|||||||1.000
70955268|NCT03592745|141414127|EQUIVALENCE|Statistical analysis of median change from baseline to week 16 (3 month follow-up) was assessed with the Upper Extremity Fugl Meyer score in the active vs. sham tVNS conditions. Null hypothesis is that there is no difference in median change in Upper Extremity Fugl Meyer score between the active and sham tVNS conditions. A significance level of 0.05 was used (two-tailed).|U value|110.5||||0.95|TWO_SIDED|||||The Mann-Whitney Wilcoxon test was performed to compare median change in Upper Extremity Fugl Meyer score from baseline to 16 weeks (follow-up) across two separate study conditions (active vs. sham tVNS).|Wilcoxon (Mann-Whitney)|||||||0.950
71146579|NCT00412984|141786202|SUPERIORITY|"4 key objectives were tested using a closed testing procedure. NI for the primary efficacy will be tested 1st. If NI is demonstrated then~1. superiority for the primary efficacy will be tested~2. if superiority for the primary efficacy is~   1. not demonstrated, stop~  2. demonstrated, then superiority for MB will be tested~3. if superiority for MB is~   1. not demonstrated, stop~  2. demonstrated, then superiority for all cause death will be tested All tests will be done at 1-sided α = 0.025"|Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.6|0.8|||Cox Proportional Hazards Model|Model included treatment group as a covariate; stratified by investigative site and prior warfarin/vitamin K antagonist status.|apixaban / warfarin|||0.80|0.60|<.0001
70874141|NCT00555321|141233042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||||TWO_SIDED|95.0|-15.6|4.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||4.5|-15.6|
70874142|NCT00555321|141233042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|||||TWO_SIDED|95.0|-12.7|3.9|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||3.9|-12.7|
70874143|NCT00555321|141233042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||95.0|||||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||||
70874144|NCT00555321|141233042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||||TWO_SIDED|95.0|-18.2|5.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||5.3|-18.2|
71146580|NCT00412984|141786204|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.0465|TWO_SIDED|95.0|0.8|1.0|||Cox Proportional Hazards Model|Model included treatment group as a covariate; stratified by investigative site and prior warfarin/vitamin K antagonist status.|apixaban / warfarin|"4 key objectives were tested using a closed testing procedure. NI for the primary efficacy will be tested 1st. If NI is demonstrated then~1. superiority for the primary efficacy will be tested~2. if superiority for the primary efficacy is~   1. not demonstrated, stop~  2. demonstrated, then superiority for MB will be tested~3. if superiority for MB is~   1. not demonstrated, stop~  2. demonstrated, then superiority for all cause death will be tested All tests will be done at 1-sided α = 0.025"||1.00|0.80|0.0465
71146581|NCT00412984|141786205|OTHER||Hazard Ratio (HR)|0.92||||0.422|TWO_SIDED|95.0|0.74|1.13||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Ischemic or Unspecified Stroke||1.13|0.74|0.4220
71146582|NCT00412984|141786205|OTHER||Hazard Ratio (HR)|0.51||||0.0006|TWO_SIDED|95.0|0.35|0.75||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Hemorrhagic Stroke||0.75|0.35|0.0006
71146583|NCT00412984|141786205|OTHER||Hazard Ratio (HR)|0.87||||0.702|TWO_SIDED|95.0|0.44|1.75||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Systemic Embolism||1.75|0.44|0.7020
71146584|NCT00412984|141786205|OTHER||Hazard Ratio (HR)|0.88||||0.372|TWO_SIDED|95.0|0.66|1.17||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Myocardial Infarction||1.17|0.66|0.3720
70874145|NCT00555321|141233042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|||||TWO_SIDED|95.0|-14.9|4.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||4.5|-14.9|
70874146|NCT00555321|141233042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||95.0|||||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||||
71146585|NCT00412984|141786206|OTHER||Hazard Ratio (HR)|0.77|||<|0.0001|TWO_SIDED|95.0|0.69|0.86||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Stroke / Systemic Embolism / Major Bleeding||0.86|0.69|<.0001
71146586|NCT00412984|141786206|OTHER||Hazard Ratio (HR)|0.89||||0.0192|TWO_SIDED|95.0|0.81|0.98||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Stroke / Systemic Embolism / All-Cause Death||0.98|0.81|0.0192
70874147|NCT00555321|141233042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||||TWO_SIDED|95.0|-15.6|4.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||4.5|-15.6|
70874148|NCT00555321|141233042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|||||TWO_SIDED|95.0|-12.7|3.9|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||3.9|-12.7|
70874149|NCT00555321|141233043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.7|||||TWO_SIDED|95.0|-25.6|10.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||10.2|-25.6|
70874150|NCT00555321|141233043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4|||||TWO_SIDED|95.0|-11.7|22.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||22.3|-11.7|
70874151|NCT00555321|141233043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3|||||TWO_SIDED|95.0|-20.1|15.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||15.2|-20.1|
70874152|NCT00555321|141233043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0|||||TWO_SIDED|95.0|-24.0|12.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||12.5|-24.0|
70955269|NCT03406078|141414151|SUPERIORITY||Cumulative Odds Ratio|1.28||||0.434|TWO_SIDED|95.0|0.69|2.35|||Proportional odds model|Response variable: categorised % reduction from baseline in final OCS dose. Covariates in the model: treatment, region and daily OCS dose at baseline.||||2.35|0.69|0.434
70955270|NCT02186600|141414172|OTHER|Hierarchical linear modeling for intent-to-treat analysis to analyze time X group interactions, adjusted for baseline total body lean mass and height.||||||0.7|||||||hierarchical linear modeling|controlled for total lean mass and height||||||0.7
70955271|NCT02186600|141414173|OTHER|hierarchical linear modeling||||||0.01|||||||hierarchical linear modeling|||||||0.01
70955272|NCT02186600|141414174|OTHER|Hierarchical linear modeling|||||<|0.007|||||||hierarchical linear modeling|||||||<0.007
70955273|NCT00293059|141414195|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||inverting 2 one-sided tests|||||||< 0.0001
70955274|NCT00350103|141414249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|||=|0.041|TWO_SIDED|95.0|-0.88|-0.02|||ANCOVA||Estimated value is the difference of Least Square Means.|Last Observation Carried Forward (LOCF) procedure was applied for missing daily diary entries between start of trial medication and Visit 8 or last intake of trial medication in the case of discontinuation during the Titration or Maintenance Phase.||-0.02|-0.88|=0.0410
70955275|NCT00350103|141414249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|||=|0.2902|TWO_SIDED|95.0|-0.65|0.2|||ANCOVA||Estimated value is the difference of Least Square Means.|Last Observation Carried Forward (LOCF) procedure was applied for missing daily diary entries between start of trial medication and Visit 8 or last intake of trial medication in the case of discontinuation during the Titration or Maintenance Phase.||0.20|-0.65|=0.2902
71146587|NCT00412984|141786206|OTHER||Hazard Ratio (HR)|0.85||||0.0002|TWO_SIDED|95.0|0.78|0.92||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Stroke / Systemic Embolism / Major Bleeding / All-Cause Death||0.92|0.78|0.0002
71146588|NCT00412984|141786206|OTHER||Hazard Ratio (HR)|0.88||||0.0107|TWO_SIDED|95.0|0.8|0.97||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Stroke / Systemic Embolism / MI / All-Cause Death||0.97|0.80|0.0107
71146589|NCT00412984|141786206|OTHER||Hazard Ratio (HR)|0.9||||0.0432|TWO_SIDED|95.0|0.82|1.0||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Ischemic or Unspecified Stroke / All-Cause Death||1.00|0.82|0.0432
71146590|NCT00412984|141786206|OTHER||Hazard Ratio (HR)|0.88||||0.0167|TWO_SIDED|95.0|0.79|0.98||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Hemorrhagic Stroke / All-Cause Death||0.98|0.79|0.0167
71146591|NCT00412984|141786206|OTHER||Hazard Ratio (HR)|0.89||||0.0464|TWO_SIDED|95.0|0.8|1.0||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Systemic Embolism / All-Cause Death||1.00|0.80|0.0464
70955276|NCT04828837|141414289|SUPERIORITY|The intervention effect was evaluated using the generalized estimating equation (GEE) statistical method. Two-tailed tests were conducted, and p-values less than .05 were considered statistically significant.|Mean Difference (Final Values)|0.39|||<|0.05|TWO_SIDED|95.0||||We used Mann-Whitney U test for independent samples, and Fisher's exact tests when more than 20% of cells have expected frequencies \<5 or less than 10 observations to examine the homogeneity between groups based on demographic characteristics.|Wilcoxon (Mann-Whitney)|||Descriptive statistics, including count, percentage, mean, and standard deviation, were used to summarize the data.||||<0.05
70955277|NCT04828837|141414290|SUPERIORITY|The intervention effect was evaluated using the generalized estimating equation (GEE) statistical method. Two-tailed tests were conducted, and p-values less than .05 were considered statistically significant.|||||<|0.05||||||We used Mann-Whitney U test for independent samples, and Fisher's exact tests when more than 20% of cells have expected frequencies \<5 or less than 10 observations to examine the homogeneity between groups based on demographic characteristics.|The generalized estimating equation (GEE|||Descriptive statistics, including count, percentage, mean, and standard deviation, were used to summarize the data.||||<0.05
70955278|NCT04828837|141414291|SUPERIORITY|The intervention effect was evaluated using the generalized estimating equation (GEE) statistical method. Two-tailed tests were conducted, and p-values less than .05 were considered statistically significant.|||||<|0.05||||||We used Mann-Whitney U test for independent samples, and Fisher's exact tests when more than 20% of cells have expected frequencies \<5 or less than 10 observations to examine the homogeneity between groups based on demographic characteristics.|The generalized estimating equation (GEE|||Descriptive statistics, including count, percentage, mean, and standard deviation, were used to summarize the data.||||<0.05
70955279|NCT04828837|141414292|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
70955280|NCT05453201|141414305|OTHER|||||||0.06|||||||paired t-test|||This analysis uses the functional disability subscale from pre- to post-intervention.||||.06
70955281|NCT05453201|141414305|OTHER|||||||0.004|||||||paired t-test|||This analysis uses the symptom severity subscale from pre- to post-intervention.||||.004
70955282|NCT05453201|141414305|OTHER|||||||0.1|||||||paired t-test|||This analysis uses the perceived overall health now subscale (1 item) from pre- to post-intervention.||||.10
70955283|NCT05453201|141414306|OTHER|||||||0.46|||||||paired t-test|||This analysis uses domain 1 from pre- to post-intervention.||||.46
71146592|NCT00412984|141786206|OTHER||Hazard Ratio (HR)|0.89||||0.0253|TWO_SIDED|95.0|0.8|0.99||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Myocardial Infarction / All-Cause Death||0.99|0.80|0.0253
71146593|NCT00412984|141786208|OTHER||Hazard Ratio (HR)|0.8||||0.0098|TWO_SIDED|95.0|0.67|0.95||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite Stroke/Systemic Embolism/Major Bleeding in Warfarin/Vitamin K Antagonist (VKA) Naive Participants||0.95|0.67|0.0098
71146594|NCT00412984|141786211|OTHER||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|95.0|0.61|0.75||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin|||0.75|0.61|<.0001
71146595|NCT00412984|141786213|OTHER||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.68|0.75||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin|||0.75|0.68|<.0001
71146596|NCT00412984|141786214|OTHER||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.35|0.6||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin|Severe GUSTO bleeding events||0.60|0.35|<.0001
71146597|NCT00412984|141786214|OTHER||Hazard Ratio (HR)|0.6|||<|0.0001|TWO_SIDED|95.0|0.5|0.71||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin|Severe or Moderate GUSTO bleeding events||0.71|0.50|<.0001
71146598|NCT00412984|141786215|OTHER||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.46|0.7||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin|Major TIMI bleeding event||0.70|0.46|<.0001
71146599|NCT00412984|141786215|OTHER||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.54|0.75|||Cox Proportional Hazard Model||apixaban / warfarin|Major or Minor TIMI bleeding criteria||0.75|0.54|<.0001
71146600|NCT00412984|141786217|OTHER||Hazard Ratio (HR)|0.74|||<|0.0001|TWO_SIDED|95.0|0.65|0.83||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin|||0.83|0.65|<.0001
71146601|NCT04218240|141786218|SUPERIORITY|||||||0.05|||||||Chi-squared|1 degree of freedom||A nonparametric (Kruskal-Wallis) comparison of the two groups (p=0.049)||||.05
71146602|NCT04218240|141786219|OTHER|Chi-square analysis||||||0.27|||||||Chi-squared|||hypothesis: more people in active PGB/LFX will complete withdrawal CI = 95% P = 0.5||||0.27
71146603|NCT02435212|141786237|SUPERIORITY||Least squares mean|2.58|STANDARD_ERROR_OF_MEAN|2.803||0.3598|TWO_SIDED|95.0|-2.99|8.15|||ANCOVA|||||8.15|-2.99|0.3598
71146604|NCT02435212|141786238|SUPERIORITY||Least squares mean|176.36|STANDARD_ERROR_OF_MEAN|153.933||0.2546|TWO_SIDED|95.0|-129.0|481.72|||ANCOVA|||||481.72|-129.00|0.2546
71146605|NCT05179785|141786258|OTHER|||||||0.2938909|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.29389090
71146606|NCT05179785|141786258|OTHER|||||||0.97863544|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.97863544
71146607|NCT05179785|141786258|OTHER|||||||0.60236264|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.60236264
71146608|NCT05179785|141786258|OTHER|||||||0.35845126|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.35845126
71146609|NCT05179785|141786258|OTHER|||||||0.91766025|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.91766025
71146610|NCT05179785|141786258|OTHER|||||||0.09605169|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delayed discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delayed discounting task"||||0.09605169
71146611|NCT05179785|141786259|OTHER|||||||0.50030946|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.50030946
71146612|NCT05179785|141786259|OTHER|||||||0.3751738|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.37517380
71146613|NCT05179785|141786259|OTHER|||||||0.47876971|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.47876971
71146614|NCT05179785|141786259|OTHER|||||||0.21798816|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.21798816
71146615|NCT05179785|141786259|OTHER|||||||0.47876971|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.47876971
70955284|NCT05453201|141414306|OTHER|||||||0.2|||||||paired t-test|||This analysis uses domain 2 from pre- to post-intervention.||||.20
71146616|NCT05179785|141786259|OTHER|||||||0.21798816|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.21798816
71146617|NCT05179785|141786260|OTHER|||||||0.75298499|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.75298499
70955285|NCT05453201|141414306|OTHER|||||||0.42|||||||paired t-test|||This analysis uses domain 3 from pre- to post-intervention.||||.42
70955286|NCT05453201|141414306|OTHER|||||||0.84|||||||paired t-test|||This analysis uses domain 4 from pre- to post-intervention.||||.84
70955287|NCT05453201|141414306|OTHER|||||||0.25|||||||paired t-test|||This analysis uses domain 5 (part 1) from pre- to post-intervention.||||.25
70955288|NCT05453201|141414306|OTHER|||||||0.26|||||||paired t-test|||This analysis uses domain 6 from pre- to post-intervention.||||.26
71146618|NCT05179785|141786260|OTHER|||||||0.16043787|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.16043787
70874153|NCT00555321|141233043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|||||TWO_SIDED|95.0|-10.5|24.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||24.2|-10.5|
70874154|NCT00555321|141233043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-18.5|17.6|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||17.6|-18.5|
70874155|NCT00555321|141233043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.2|||||TWO_SIDED|95.0|-23.3|9.4|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||9.4|-23.3|
70874156|NCT00555321|141233043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.5|||||TWO_SIDED|95.0|-27.4|6.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||6.5|-27.4|
70874157|NCT00555321|141233043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.1|||||TWO_SIDED|95.0|-37.5|-2.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||-2.7|-37.5|
70874158|NCT00555321|141233043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|||||TWO_SIDED|95.0|-15.5|19.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||19.7|-15.5|
70955289|NCT05453201|141414307|OTHER|||||||0.89|||||||Wilcoxon test|||This analysis uses the SBQ-R total score from pre- to post-intervention.||||.89
70955290|NCT05453201|141414308|OTHER|||||||0.8|||||||paired t-test|||This analysis uses the MOCS (part A) from pre- to post-intervention.||||.80
70955291|NCT05453201|141414309|OTHER|||||||0.92|||||||paired t-test|||This analysis uses the FSCQ score (all items) from pre- to post-intervention.||||.92
70874159|NCT00555321|141233043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-19.4|16.9|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||16.9|-19.4|
70874160|NCT00555321|141233043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|||||TWO_SIDED|95.0|-29.3|7.9|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||7.9|-29.3|
70874161|NCT00555321|141233050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.4|||||TWO_SIDED|95.0|-6.3|36.0|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||36.0|-6.3|
70874162|NCT00555321|141233050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.4|||||TWO_SIDED|95.0|-23.4|10.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||10.2|-23.4|
70874163|NCT00555321|141233050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.2|||||TWO_SIDED|95.0|-23.4|10.0|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||10.0|-23.4|
70874164|NCT00555321|141233050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-22.0|23.4|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||23.4|-22.0|
70874165|NCT00555321|141233050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5|||||TWO_SIDED|95.0|-38.6|-0.1|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||-0.1|-38.6|
70874166|NCT00555321|141233050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.2|||||TWO_SIDED|95.0|-39.1|-1.8|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||-1.8|-39.1|
70874167|NCT00555321|141233050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.8|||||TWO_SIDED|95.0|-8.7|34.0|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||34.0|-8.7|
70874168|NCT00555321|141233050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1|||||TWO_SIDED|95.0|-25.2|8.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||8.7|-25.2|
70955292|NCT05453201|141414309|OTHER|||||||0.9|||||||Wilcoxon test (paired)|||This analysis uses the FSCQ similarity subscale from pre- to post-intervention.||||.90
70955293|NCT05453201|141414309|OTHER|||||||0.74|||||||paired t-test|||This analysis uses the FSCQ vividness subscale from pre- to post-intervention.||||.74
70955294|NCT05453201|141414309|OTHER|||||||0.44|||||||paired t-test|||This analysis uses the FSCQ positivity subscale from pre- to post-intervention.||||.44
70955295|NCT05453201|141414310|OTHER|||||||0.003|||||||paired t-test|||This analysis uses the PHQ-9 from pre- to post-intervention.||||.003
70955296|NCT05453201|141414311|OTHER|||||||0.01|||||||paired t-test|||This analysis uses the GAD-7 from pre- to post-intervention.||||.01
70955297|NCT05453201|141414312|OTHER|||||||0.04|||||||paired t-test|||This analysis uses the QOLS from pre- to post-intervention.||||.04
70955298|NCT05453201|141414313|OTHER|"The AIM measures an intervention's acceptability. Therefore, the goal is not change over time, the goal is to assess, descriptively, post-intervention acceptability. Because we assessed this measure at baseline (with expectations of the future treatment), we provide a paired t-test with the AIM at pre- and post-intervention."||||||0.24|||||||Paired t-test|||||||.24
70955299|NCT05453201|141414313|OTHER|"The IAM measures an intervention's appropriateness. Therefore, the goal is not change over time, the goal is to assess, descriptively, post-intervention appropriateness. Because we assessed this measure at baseline (with expectations of the future treatment), we provide a paired t-test with the IAM at pre- and post-intervention."||||||0.82|||||||Paired t-test|||||||.82
70955300|NCT05453201|141414313|OTHER|||||||0.38|||||||Paired t-test|||"The FIM measures an intervention's feasibility. Therefore, the goal is not change over time, the goal is to assess, descriptively, post-intervention feasibility. Because we assessed this measure at baseline (with expectations of the future treatment), we provide a paired t-test with the FIM at pre- and post-intervention."||||.38
70955301|NCT03465904|141414340|SUPERIORITY|Our power analysis indicated that a minimum of 239 patients per group was needed to provide 90% power to detect a 13.4% difference in the primary outcome, pain freedom at 2 h. Accounting for an estimated attrition rate of 20%, we aimed to enroll 299 patients per group.|||||<|0.05||||||All analyses were performed using SPSS, version 26.0 with two-sided levels of statistical significance established at p \< 0.05|Chi-squared|A Chi-square test of independent proportions was used to compare primary and secondary efficacy outcomes between groups.||Identical statistical analyses were performed for the intent-to-treat (ITT) and the per protocol (PP) populations. The ITT population consisted of all randomized patients, who received any duration of sham or verum treatment and returned completed study materials. The PP population consisted of patients who strictly met inclusion criteria and completed at least 60 min of treatment.||||<0.05
70955302|NCT01209234|141414348|SUPERIORITY||Cox Proportional Hazard|0.7|STANDARD_ERROR_OF_MEAN|0.024||0.026|TWO_SIDED|95.0|0.52|0.96|||Regression, Cox||This is the estimated standard error of the log hazard ratio|||0.96|0.52|0.026
70955303|NCT01209234|141414349|SUPERIORITY||Cox Proportional Hazard|0.84|STANDARD_ERROR_OF_MEAN|0.009||0.061|TWO_SIDED|95.0|0.7|1.01||Not adjusted for multiple comparisons|Regression, Cox||CDC-defined all-cause infection secondary outcome This is the estimated standard error of the log hazard ratio|||1.01|0.70|0.061
70955304|NCT01209234|141414349|SUPERIORITY||Cox Proportional Hazard|0.83|STANDARD_ERROR_OF_MEAN|0.008||0.035|TWO_SIDED|95.0|0.7|0.99||Not adjusted for multiple comparisons|Regression, Cox||Clinical criteria for all-cause infection This is the estimated standard error of the log hazard ratio|||0.99|0.70|0.035
70955305|NCT00925353|141414357|SUPERIORITY_OR_OTHER||Actual lab results shown|1.0|||<|0.05||95.0|||||non-compartmental pharmacokinetic|The planned analysis was to estimate pharmacokinetic parameters. There were too few detectable values to be able to perform this analysis.||Null Hypothesis: Application of 4% lidocaine gel on the breasts and chest wall of healthy women occluded for one hour does not result in systemically toxic plasma concentrations of lidocaine or its principal metabolite, monoethylglycinexyliidie (MEGX), electrocardiogram changes, or adverse events.||||<0.05
70955306|NCT01302067|141414367|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.91|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.16|-0.66||Primary comparison was 8 mg VS. 4 mg (closed-testing method). Treatment effect of 8 mg VS. placebo was tested 1st. Treatment difference of 8 mg VS. 4 mg was tested if a statistically significant difference between 8 mg and placebo was shown.|ANCOVA|Using a closed testing procedure, no adjustments of α-level was needed at each stage of testing. Each was done at the 0.05 significance level.|Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Comparisons were done with 2-sided test at 5% significance level. Null hypothesis: mean change from BL in the number of UUI episodes per 24 hours in the 8mg group was same as 4mg group at Week 12. ANCOVA was used to compare 8mg and 4mg arms for numeric change from BL - Week 12. This included terms for treatment, country, centered BL value and centered BL by treatment interaction, in which centered BL (BL - mean BL) was used to ensure that treatment effect was estimated at mean covariate value.||-0.66|-1.16|<0.0001
70955307|NCT01302067|141414367|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.11||0.0109|TWO_SIDED|95.0|-0.48|-0.06||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Treatment comparisons were performed with a two-sided test at the 5% significance level.||-0.06|-0.48|0.0109
70874169|NCT00555321|141233050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.8|||||TWO_SIDED|95.0|-26.3|7.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||7.7|-26.3|
70955308|NCT01302067|141414367|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.89|-0.39||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Treatment comparisons were performed with a two-sided test at the 5% significance level.||-0.39|-0.89|<0.0001
70955309|NCT01302067|141414368|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.13|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.48|-0.79||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.79|-1.48|<0.0001
70955310|NCT01302067|141414368|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.14||0.0082|TWO_SIDED|95.0|-0.67|-0.1||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.10|-0.67|0.0082
70955311|NCT01302067|141414368|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.75|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.1|-0.41||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.41|-1.10|<0.0001
70955312|NCT01302067|141414369|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.76|-1.03||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-1.03|-1.76|<0.0001
70955313|NCT01302067|141414369|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.15||0.0006|TWO_SIDED|95.0|-0.83|-0.23||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.23|-0.83|0.0006
70955314|NCT01302067|141414369|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.23|-0.51||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.51|-1.23|<0.0001
70955315|NCT01302067|141414370|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
70955316|NCT01302067|141414370|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||0.0040
70955317|NCT01302067|141414370|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
71146619|NCT05179785|141786260|OTHER|||||||0.67902693|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.67902693
71146620|NCT05179785|141786260|OTHER|||||||0.33832977|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.33832977
70955318|NCT01302067|141414371|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
70955319|NCT01302067|141414371|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
70955320|NCT01302067|141414371|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
70955321|NCT01302067|141414372|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.02|-0.5||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||-0.50|-1.02|<0.0001
71146621|NCT05179785|141786260|OTHER|||||||0.67902693|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.67902693
70955322|NCT01302067|141414372|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0662|TWO_SIDED|95.0|-0.41|0.01||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||0.01|-0.41|0.0662
70955323|NCT01302067|141414372|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.82|-0.3||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||-0.30|-0.82|<0.0001
70955324|NCT01302067|141414373|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
70955325|NCT01302067|141414373|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
70955326|NCT01302067|141414374|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
70955327|NCT01302067|141414374|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||0.0006
70955328|NCT01302067|141414374|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||0.0001
70955329|NCT01302067|141414375|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.55|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-2.04|-1.06||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-1.06|-2.04|<0.0001
70955330|NCT01302067|141414375|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.21||0.0121|TWO_SIDED|95.0|-0.92|-0.11||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.11|-0.92|0.0121
70955331|NCT01302067|141414375|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.04|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.52|-0.55||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.55|-1.52|<0.0001
70955332|NCT01302067|141414376|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.02|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-2.55|-1.49||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-1.49|-2.55|<0.0001
70955333|NCT01302067|141414376|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.78|STANDARD_ERROR_OF_MEAN|0.22||0.0005|TWO_SIDED|95.0|-1.22|-0.34||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.34|-1.22|0.0005
70955334|NCT01302067|141414376|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.24|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-1.77|-0.71||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.71|-1.77|<0.0001
70955335|NCT01302067|141414377|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
70955336|NCT01302067|141414377|SUPERIORITY_OR_OTHER|||||||0.0348|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||0.0348
70955337|NCT01302067|141414377|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||0.0003
70874170|NCT00555321|141233050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|||||TWO_SIDED|95.0|-24.5|21.1|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12.||21.1|-24.5|
70874171|NCT00555321|141233050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.2|||||TWO_SIDED|95.0|-40.5|-1.9|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||-1.9|-40.5|
70874172|NCT00555321|141233050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.9|||||TWO_SIDED|95.0|-41.8|-4.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||-4.3|-41.8|
70874173|NCT00580606|141233097|SUPERIORITY_OR_OTHER||Risk Difference (RD)|55.0|||<|0.001|TWO_SIDED|95.0|22.2|77.6||No adjustments were made to the p-value.|Barnard's Statistic|The a priori threshold for statistical significance is 0.05.||Number of participants who successfully consumed 5,000 mg of peanut powder or at least a 10-fold increase in the amount of peanut powder compared to their baseline OFC was compared using Barnard's Statistic with the null hypothesis that there was no difference between treatment groups.||77.6|22.2|<0.001
70874174|NCT03918447|141233106|SUPERIORITY||Least Square Means Difference|0.97|STANDARD_ERROR_OF_MEAN|1.122|=|0.3886|TWO_SIDED|95.0|-1.25|3.19|||ANCOVA|||ANCOVA model with baseline eGFR as a covariate, and treatment group as fixed effects.||3.19|-1.25|=0.3886
70874175|NCT03918447|141233108|SUPERIORITY||Least Square Means Difference|7.94|STANDARD_ERROR_OF_MEAN|0.777|<|0.0001|TWO_SIDED|95.0|6.41|9.47|||MMRM|||Mixed model repeated measure (MMRM) model used baseline eGFR as a covariate, and the following fixed factors: treatment group, time (Week 1 to 100, excluding Week 52), and the interaction between treatment and time. Within-participant errors are modeled using an unstructured covariance matrix.||9.47|6.41|<0.0001
70874176|NCT01405456|141233165|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Change in Insulin Stimulated Glucose Uptake measured during euglycemic hyperinsulinemic clamp procedure from baseline to 6 months||||0.71
70874177|NCT01405456|141233166|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||Change in Visceral Adipose Tissue area as measured by magnetic resonance imaging of the abdomen from baseline to 6 months||||0.42
70874178|NCT01405456|141233167|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Change in Liver Fat (Intrahepatic Lipid) as measured by magnetic resonance spectroscopy from baseline to 6 months||||0.51
70874179|NCT01405456|141233168|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Change in Intramyocellular Lipid of calf muscles as measured by magnetic resonance spectroscopy from baseline to 6 months||||0.04
70874180|NCT01405456|141233169|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Change in Flow Mediated Vasodilation (maximum percentage) from baseline to 6 months||||0.44
70874181|NCT01405456|141233170|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||Mean serum measurements of Potassium||||0.07
70874182|NCT01405456|141233171|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Change in Hemoglobin A1c from baseline to 6 months||||0.70
70874183|NCT01405456|141233172|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Change in C-Reactive Protein from baseline to 6 months||||0.10
70874184|NCT01405456|141233173|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||Change in Plasminogen Activator Inhibitor 1 from baseline to 6 months||||0.37
70874185|NCT01405456|141233174|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Change in Adiponectin from baseline to 6 months||||0.78
70874186|NCT01405456|141233175|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Change in IL-6 from baseline to 6 months||||0.10
70874187|NCT01405456|141233176|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Change in MCP-1 from baseline to 6 months||||0.04
70874188|NCT05353985|141233177|SUPERIORITY||LS Mean Difference|0.017|||=|0.847|TWO_SIDED|95.0|-0.162|0.197||P-value was based on a MMRM analysis with treatment group, week, treatment-by-week interaction, \& the randomization stratification factors as fixed effects \& baseline CDSD GI symptom severity scores as covariates, and participant as a random effect.|MMRM|||||0.197|-0.162|=0.847
70955338|NCT01302067|141414378|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
70874189|NCT05353985|141233178|SUPERIORITY||LS Mean Difference|-0.331|||<|0.001|TWO_SIDED|95.0|-0.481|-0.181||P-value was based on a ANCOVA model with treatment group and randomization stratification factors as fixed effects and baseline Vh:Cd as covariates.|ANCOVA|||||-0.181|-0.481|<0.001
70874190|NCT02989194|141233188|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.158||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 2. All null hypotheses were defined as no treatment difference.||||0.158
70874191|NCT02989194|141233188|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.025||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 3. All null hypotheses were defined as no treatment difference.||||0.025
70874192|NCT02989194|141233188|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.007||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 4. All null hypotheses were defined as no treatment difference.||||0.007
70874193|NCT02989194|141233188|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.061||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 5. All null hypotheses were defined as no treatment difference.||||0.061
70874194|NCT02989194|141233188|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.107||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 6. All null hypotheses were defined as no treatment difference.||||0.107
70874195|NCT02989194|141233188|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.237||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 7. All null hypotheses were defined as no treatment difference.||||0.237
70874196|NCT02989194|141233188|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.497||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 8. All null hypotheses were defined as no treatment difference.||||0.497
70874197|NCT02989194|141233188|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.704||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 9. All null hypotheses were defined as no treatment difference.||||0.704
70874198|NCT02989194|141233188|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.585||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 10. All null hypotheses were defined as no treatment difference.||||0.585
70874199|NCT02989194|141233199|SUPERIORITY|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.083|||||||t-test, 2 sided|||A t-test was used to assess the difference between the VIS410 total and placebo treatment groups from nasopharyngeal swabs based on the TCID50.||||0.083
70874200|NCT02989194|141233200|SUPERIORITY|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.169||||||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.|t-test, 2 sided|||The null hypothesis was defined as no treatment difference.||||0.169
70874201|NCT02989194|141233201|SUPERIORITY|Descriptive Statistics. Statistical comparisons were performed using log rank test.||||||0.028||||||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.|Log Rank|||Kaplan-Meier methods were used to calculate the median time. All null hypotheses were defined as no treatment difference.|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level, unless specifically stated otherwise. All null hypotheses were defined as no treatment difference. All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.|||0.028
70955339|NCT01302067|141414378|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||0.0002
70874202|NCT02989194|141233203|EQUIVALENCE|Descriptive Statistics. All statistical comparisons were performed at the 0.05 significance level.||||||0.173||||||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.|Log Rank|Kaplan-Meier methods were used to calculate the median time, 25th percentile and 75th percentile.||All null hypotheses were defined as no treatment difference.||||0.173
70874203|NCT01327885|141233204|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.768|||=|0.0169|TWO_SIDED|95.0|0.618|0.954||The P-value was calculated by 2-sided log-rank test as stratified by histology, geographic region, and number of prior regimens for advanced STS.|Log Rank||The Hazard Ratio is based on a stratified Cox regression model including treatment as covariate, and histology, geographic region, and number of prior regimens for advanced STS as strata.|Statistical analysis was designed to detect superiority of Arm A (eribulin) over Arm B (dacarbazine). OS was compared between the two treatment arms using a two-sided stratified log-rank test at a nominal significance level of 0.0455 (adjusted for the interim analysis). This was the primary analysis that was performed when the target number of events (\~353 deaths) was observed.||0.954|0.618|=0.0169
71146622|NCT05179785|141786260|OTHER|||||||0.33832977|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.33832977
71146623|NCT05179785|141786261|OTHER|||||||0.73357221|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.73357221
71146624|NCT05179785|141786261|OTHER|||||||0.43954526|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.43954526
71146625|NCT05179785|141786261|OTHER|||||||0.4419898|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.44198980
71146626|NCT05179785|141786261|OTHER|||||||0.39565784|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.39565784
71146627|NCT05179785|141786261|OTHER|||||||0.35602382|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.35602382
71146628|NCT05179785|141786261|OTHER|||||||0.30499144|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.30499144
71146629|NCT05179785|141786262|OTHER|||||||0.81601415|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.81601415
71146630|NCT05179785|141786262|OTHER|||||||0.20563452|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.20563452
71146631|NCT05179785|141786262|OTHER|||||||0.21947623|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.21947623
71146632|NCT05179785|141786262|OTHER|||||||0.45535329|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.45535329
71146633|NCT05179785|141786262|OTHER|||||||0.21947623|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.21947623
71146634|NCT05179785|141786262|OTHER|||||||0.45535329|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.45535329
71146635|NCT05179785|141786263|OTHER|||||||0.83462055|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.83462055
71146636|NCT05179785|141786263|OTHER|||||||0.21582586|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.21582586
71146637|NCT05179785|141786263|OTHER|||||||0.59574875|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.59574875
71146638|NCT05179785|141786263|OTHER|||||||0.75948776|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.75948776
71146639|NCT05179785|141786263|OTHER|||||||0.7238414|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.72384140
71146640|NCT05179785|141786263|OTHER|||||||0.00477281|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.00477281
71146641|NCT05179785|141786264|OTHER|||||||0.20047055|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.20047055
71146642|NCT05179785|141786264|OTHER|||||||0.77922802|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.77922802
71146643|NCT05179785|141786264|OTHER|||||||0.29196708|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.29196708
70955340|NCT01302067|141414378|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
70955341|NCT01302067|141414379|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.||||<0.0001
70955342|NCT01302067|141414379|SUPERIORITY_OR_OTHER|||||||0.0057|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.||||0.0057
70955343|NCT01302067|141414379|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.||||0.0008
70955344|NCT01302067|141414380|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.||||0.0007
70955345|NCT01302067|141414380|SUPERIORITY_OR_OTHER|||||||0.0091|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.||||0.0091
70955346|NCT01302067|141414380|SUPERIORITY_OR_OTHER|||||||0.3901|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.||||0.3901
71146644|NCT05179785|141786264|OTHER|||||||0.05605962|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.05605962
70874204|NCT01327885|141233205|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.877|||=|0.2287|TWO_SIDED|95.0|0.71|1.085||P-value was calculated by 2-sided log-rank test, as stratified by histology, geographic region, and number of prior regimens for advanced STS.|Log Rank||The Hazard Ratio is based on a stratified Cox regression model including treatment as covariate, and histology, geographic region, and number of prior regimens for advanced STS as strata.|The PFS and PFS rate at 3, 6, and 12 months (95% confidence interval (CI)) was calculated using Kaplan-Meier (K-M) product-limit method and Greenwood Formula. PFS was compared between the treatment arms using two-sided stratified log-rank test, stratified by histology, geographic region, and number of prior regimens for advanced STS.||1.085|0.710|=0.2287
70955347|NCT01302067|141414381|SUPERIORITY_OR_OTHER||Least squares mean difference|-12.47|STANDARD_ERROR_OF_MEAN|1.54|<|0.0001|TWO_SIDED|95.0|-15.49|-9.45||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Change at Week 12- ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction was used to calculate p-value.||-9.45|-15.49|<0.0001
70955348|NCT01302067|141414381|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.69|STANDARD_ERROR_OF_MEAN|1.26||0.0002|TWO_SIDED|95.0|-7.15|-2.22||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Change at Week 12- ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction was used to calculate p-value.||-2.22|-7.15|0.0002
71146645|NCT05179785|141786264|OTHER|||||||0.57368284|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.57368284
70955349|NCT01302067|141414381|SUPERIORITY_OR_OTHER||Least squares mean difference|-7.78|STANDARD_ERROR_OF_MEAN|1.53|<|0.0001|TWO_SIDED|95.0|-10.78|-4.78||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Change at Week 12- ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction was used to calculate p-value.||-4.78|-10.78|<0.0001
71146646|NCT05179785|141786264|OTHER|||||||0.56397238|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.56397238
71146647|NCT05179785|141786265|OTHER|||||||0.86107891|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre) (dorsal anterior cingulate cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.86107891
70955350|NCT01302067|141414382|SUPERIORITY_OR_OTHER||Least squares mean difference|10.46|STANDARD_ERROR_OF_MEAN|1.67|<|0.0001|TWO_SIDED|95.0|7.2|13.73||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||13.73|7.20|<0.0001
70955351|NCT01302067|141414382|SUPERIORITY_OR_OTHER||Least squares mean difference|4.68|STANDARD_ERROR_OF_MEAN|1.36||0.0006|TWO_SIDED|95.0|2.01|7.36||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||7.36|2.01|0.0006
70955352|NCT01302067|141414382|SUPERIORITY_OR_OTHER||Least squares mean difference|5.78|STANDARD_ERROR_OF_MEAN|1.66||0.0005|TWO_SIDED|95.0|2.53|9.03||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||9.03|2.53|0.0005
70874205|NCT01327885|141233206|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.3||||0.253|TWO_SIDED|95.0|0.8|1.9||The P-value was calculated using the stratified CMH method, the stratified factors included histology, geographic region, and number of prior regimens for advanced STS.|Cochran-Mantel-Haenszel||The odds ratio between eribulin and dacarbazine was calculated by stratified CMH method. The stratified factors were as described above. The 2-sided 95% CI of the odds ratio is based on asymptotic normal approximation.|The PFR12wks was compared between the treatment arms using stratified Cochran-Mantel-Haenszel (CMH) chi-square test stratified by histology, geographic region, and number of prior regimens for advanced STS.||1.9|0.8|0.253
70874206|NCT01327885|141233207|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.9|||=|0.741|TWO_SIDED|95.0|0.7|1.4||The P-value was calculated using the CMH method. The stratified factors were histology, geographic region, and number of prior regimens for advanced STS.|Cochran-Mantel-Haenszel||The Odds Ratio between eribulin and dacarbazine was calculated by stratified CMH method. The stratified factors were as described above. The 2-sided 95% CI of Odds Ratio is based on asymptotic normal approximation.|The PFR12wks was compared between the treatment arms using stratified CMH chi-square test stratified by histology, geographic region, and number of prior regimens for advanced STS.||1.4|0.7|=0.741
70874207|NCT01577329|141233214|SUPERIORITY_OR_OTHER|||||||0.05||||||This is a calculated P value and was not adjusted for multiple comparisons.|ANOVA|||This is a calculated P value comparing two groups at baseline and follow-up||||0.05
70874208|NCT02254486|141233237|NON_INFERIORITY_OR_EQUIVALENCE|The confidence limits were adjusted for multiple comparisons (two alternative primary endpoints): To be declared non-inferior, the primary endpoint must show a difference in success rates of no greater than 10% in favor of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in success rate|0.14||||0.528|ONE_SIDED|97.5|-8.15|||P-value adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, the primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||The hypothesis was to demonstrate NI of NER1006 to Trisulfate Solution (TS) (10% margin). Success rate was number of patients with successful overall bowel cleansing as proportion of number of patients in each group. Treatment effect was NER1006 success rate - TS success rate. A Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||-8.15|0.528
71146648|NCT05179785|141786265|OTHER|||||||0.62228799|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre) (dorsal anterior cingulate cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.62228799
71146649|NCT05179785|141786265|OTHER|||||||0.79477883|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre) (dorsal anterior cingulate cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.79477883
71146650|NCT05179785|141786265|OTHER|||||||0.12634435|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre) (dorsal anterior cingulate cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.12634435
70955353|NCT01302067|141414383|SUPERIORITY_OR_OTHER||Least squares mean difference|10.91|STANDARD_ERROR_OF_MEAN|1.62|<|0.0001|TWO_SIDED|95.0|7.73|14.09||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||14.09|7.73|<0.0001
71146651|NCT05179785|141786265|OTHER|||||||0.79477883|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre) (dorsal anterior cingulate cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.79477883
71146652|NCT05179785|141786265|OTHER|||||||0.12634435|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre) (dorsal anterior cingulate cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.12634435
71146653|NCT05179785|141786265|OTHER|||||||0.62461968|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.62461968
71146654|NCT05179785|141786265|OTHER|||||||0.51324793|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.51324793
71146655|NCT05179785|141786265|OTHER|||||||0.60543603|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.60543603
70955354|NCT01302067|141414383|SUPERIORITY_OR_OTHER||Least squares mean difference|4.36|STANDARD_ERROR_OF_MEAN|1.33||0.001|TWO_SIDED|95.0|1.76|6.96||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||6.96|1.76|0.0010
71146656|NCT05179785|141786265|OTHER|||||||0.75565448|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.75565448
71146657|NCT05179785|141786265|OTHER|||||||0.60543603|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.60543603
71146658|NCT05179785|141786265|OTHER|||||||0.75565448|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.75565448
71146659|NCT05179785|141786266|OTHER|||||||0.09266386|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.09266386
71146660|NCT05179785|141786266|OTHER|||||||0.53980185|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.53980185
71146661|NCT05179785|141786266|OTHER|||||||0.30223686|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.30223686
71146662|NCT05179785|141786266|OTHER|||||||0.39166649|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.39166649
71146663|NCT05179785|141786266|OTHER|||||||0.30223686|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.30223686
71146664|NCT05179785|141786266|OTHER|||||||0.39166649|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.39166649
71146665|NCT05179785|141786267|OTHER|||||||0.0265|||||||t-test, 2 sided|||Paired t-test (post versus pre)||||0.0265
71146666|NCT05179785|141786267|OTHER|||||||0.1053|||||||t-test, 2 sided|||Paired t-test (post versus pre)||||0.1053
71146667|NCT05179785|141786267|OTHER|||||||0.0033|||||||t-test, 2 sided|||Paired t-test (post versus pre)||||0.0033
71146668|NCT05966142|141786268|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.5913|TWO_SIDED|95.0|-0.42|0.74|||t-test, 2 sided|||||0.74|-0.42|0.5913
71146669|NCT05966142|141786269|SUPERIORITY|||||||0.6803|||||||t-test, 2 sided|||||||0.6803
71146670|NCT05966142|141786270|SUPERIORITY|||||||0.1228|||||||Chi-squared|||||||0.1228
71146671|NCT05966142|141786271|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.5252|TWO_SIDED|95.0|-1.7|0.9|||t-test, 2 sided|||||0.9|-1.7|0.5252
71146672|NCT05966142|141786272|SUPERIORITY|||||||0.9657|||||||Chi-squared|||||||0.9657
71146673|NCT04852302|141786277|EQUIVALENCE|We evaluated the same group to determine whether their reported depression was the same, worse, or better at 6-months compared to baseline.|Mean Difference (Net)|-1.81|STANDARD_DEVIATION|4.81||0.168|TWO_SIDED|95.0|-4.47|0.86||The a priori threshold for statistical significance was \< 0.05. We did not adjust for multiple comparisons as this was exploratory.|paired sample t-Test, 2-sided|||Null hypothesis was that the mean difference between the paired observations is zero.||0.86|-4.47|0.168
71146674|NCT04852302|141786278|EQUIVALENCE|We evaluated the same group to determine whether their reported depression was the same, worse, or better at 3-months compared to baseline.|Mean Difference (Net)|-0.3|STANDARD_DEVIATION|3.59||0.752|TWO_SIDED|95.0|-2.29|1.69||The a priori threshold for statistical significance was \< 0.05. We did not adjust for multiple comparisons as this was exploratory.|paired sample t-Test, 2-sided|||||1.69|-2.29|0.752
71146675|NCT04852302|141786279|EQUIVALENCE|We evaluated the same group to determine whether their reported anxiety via the Death and Dying Distress Scale was the same, worse, or better at 3-months compared to baseline.|Mean Difference (Net)|-4.67|STANDARD_DEVIATION|16.26||0.285|TWO_SIDED|95.0|-13.67|4.34||The a priori threshold for statistical significance was \< 0.05. We did not adjust for multiple comparisons as this was exploratory.|paired sample t-Test, 2-sided|||||4.34|-13.67|0.285
71146676|NCT04852302|141786279|EQUIVALENCE|We evaluated the same group to determine whether their reported anxiety via the Death and Dying Distress Scale was the same, worse, or better at 6-months compared to baseline.|Mean Difference (Net)|-2.2|STANDARD_DEVIATION|17.22||0.628|TWO_SIDED|95.0|-11.74|7.34||The a priori threshold for statistical significance was \< 0.05. We did not adjust for multiple comparisons as this was exploratory.|paired sample t-Test, 2-sided|||||7.34|-11.74|0.628
71146677|NCT04531176|141786315|NON_INFERIORITY|The results of non-inferiority test results are between pairwise groups. Non-inferiority was tested at the 0.05 level at 1 year and performed pairwise with Bonferroni adjusted significance levels for each paired comparison.||||||0.004||||||The non-inferiority regions were set to be 1% for weight loss change. When both primary endpoints are non-inferior, superiority testing at the 0.025 overall error level with Bonferroni adjustment for each endpoint at 1 year was then performed.|t-test, 1 sided|||||||0.004
70874209|NCT02254486|141233238|NON_INFERIORITY_OR_EQUIVALENCE|The confidence limits were adjusted for multiple comparisons (two alternative primary endpoints): To be declared non-inferior the primary endpoint must show a difference in success rates of no greater than 10% in favour of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in excellent plus good rate|6.58||||0.059|ONE_SIDED|97.5|-1.69|||P-value was adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority and with 1-sided p-value \<0.025; the threshold for statistical significance.|Fisher Exact|||The hypothesis was to demonstrate NI of NER1006 to Trisulfate Solution (TS) (10% margin). Success rate was number of patients with successful overall bowel cleansing as proportion of number of patients in each group. Treatment effect was NER1006 success rate - TS success rate. A Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||-1.69|0.059
71146678|NCT04531176|141786316|NON_INFERIORITY|Non-inferiority was tested at the 0.05 level at 1 year and performed pairwise with Bonferroni adjusted significance levels for each paired comparison||||||0.05||||||The non-inferiority regions were set to be 0.5% for A1C. When both primary endpoints are non-inferior, superiority testing at the 0.025 overall error level with Bonferroni adjustment for each endpoint at 1 year was then performed.|t-test, 1 sided|||||||0.05
71146679|NCT01345240|141786487|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the difference in percent seroprotection below 5% between recipients of licensed hepatitis B vaccine (Engerix-B) and recipients of RTS,S/AS01E vaccine.|Difference in percent seroprotection|-3.95|||||TWO_SIDED|95.0|-7.12|-2.16||||||Non-inferiority of the immune response to the hepatitis B antigen induced by RTS,S/AS01E vaccine versus a licensed hepatitis B vaccine.||-2.16|-7.12|
71146680|NCT01345240|141786490|EQUIVALENCE|Criteria for consistency: one month post Dose 3 of RTS,S/AS01E, the two-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between all pairs of lots are within \[0.5, 2\].|GMC ratio|0.91|||||TWO_SIDED|95.0|0.69|1.2|||ANOVA|||To demonstrate the lot-to-lot consistency in terms of anti-HBs immunogenicity between three commercial lots of the RTS,S/AS01E candidate malaria vaccine.||1.20|0.69|
71146681|NCT01345240|141786490|EQUIVALENCE|Criteria for consistency: one month post Dose 3 of RTS,S/AS01E, the two-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between all pairs of lots are within \[0.5, 2\].|GMC ratio|1.0|||||TWO_SIDED|95.0|0.76|1.32|||ANOVA|||To demonstrate the lot-to-lot consistency in terms of anti-HBs immunogenicity between three commercial lots of the RTS,S/AS01E candidate malaria vaccine.||1.32|0.76|
71146682|NCT01345240|141786490|EQUIVALENCE|Criteria for consistency: one month post Dose 3 of RTS,S/AS01E, the two-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between all pairs of lots are within \[0.5, 2\].|GMC ratio|1.1|||||TWO_SIDED|95.0|0.84|1.45|||ANOVA|||To demonstrate the lot-to-lot consistency in terms of anti-HBs immunogenicity between three commercial lots of the RTS,S/AS01E candidate malaria vaccine.||1.45|0.84|
70955355|NCT01302067|141414383|SUPERIORITY_OR_OTHER||Least squares mean difference|6.55|STANDARD_ERROR_OF_MEAN|1.61|<|0.0001|TWO_SIDED|95.0|3.39|9.72||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||9.72|3.39|<0.0001
71146683|NCT01345240|141786498|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.15|||||TWO_SIDED|95.0|0.95|1.39|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 1 responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.39|0.95|
71146684|NCT01345240|141786498|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.2|||||TWO_SIDED|95.0|0.97|1.48|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 4 responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.48|0.97|
71146685|NCT01345240|141786498|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.27|||||TWO_SIDED|95.0|1.06|1.52|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 5 responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.52|1.06|
71146686|NCT01345240|141786498|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.17|||||TWO_SIDED|95.0|0.83|1.65|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 6B responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.65|0.83|
71146687|NCT01345240|141786498|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.12|||||TWO_SIDED|95.0|0.94|1.33|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 7F responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.33|0.94|
71146688|NCT01345240|141786498|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.32|||||TWO_SIDED|95.0|1.08|1.63|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 9V responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.63|1.08|
71146689|NCT01345240|141786498|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|0.99|||||TWO_SIDED|95.0|0.77|1.27|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 14 responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.27|0.77|
71146690|NCT01345240|141786498|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.81|||||TWO_SIDED|95.0|1.38|2.38|||ANOVA|||To demonstrate the non-inferiority of antibody against 18C responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||2.38|1.38|
71146691|NCT01345240|141786498|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.21|||||TWO_SIDED|95.0|0.89|1.65|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 19F responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.65|0.89|
71146692|NCT01345240|141786498|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.12|||||TWO_SIDED|95.0|0.81|1.55|||ANOVA|||To demonstrate the non-inferiority of antibody against 23F responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.55|0.81|
71146693|NCT01345240|141786504|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of anti-PT, anti-FHA, anti-PRN antibody concentrations, is below a limit of 2 for the DTPa/Hib vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.08|||||TWO_SIDED|95.0|0.97|1.2|||ANOVA|||To demonstrate the non-inferiority of antibody response to the acellular B pertussis antigen, pertussis toxoid, (PT) of the DTPa/Hib vaccine when co-administered with RTS,S/AS01E as part of an EPI regimen.||1.20|0.97|
71146694|NCT01345240|141786504|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of anti-PT, anti-FHA, anti-PRN antibody concentrations, is below a limit of 2 for the DTPa/Hib vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.08|||||TWO_SIDED|95.0|0.97|1.21|||ANOVA|||To demonstrate the non-inferiority of antibody response to the acellular B pertussis antigen, filamentous haemagglutinin (FHA), of the DTPa/Hib vaccine when co-administered with RTS,S/AS01E as part of an EPI regimen.||1.21|0.97|
71146695|NCT01345240|141786504|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of anti-PT, anti-FHA, anti-PRN antibody concentrations, is below a limit of 2 for the DTPa/Hib vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.1|||||TWO_SIDED|95.0|0.98|1.22|||ANOVA|||To demonstrate the non-inferiority of antibody response to the acellular B pertussis antigen, pertactin (anti-PRN), of the DTPa/Hib vaccine when co-administered with RTS,S/AS01E as part of an EPI regimen.||1.22|0.98|
71146696|NCT01345240|141786505|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 2, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the geometric mean concentrations (GMC) ratios of rotavirus antibodies (IgA) concentrations is below 2 for the rotavirus vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.11|||||TWO_SIDED|95.0|0.76|1.61|||ANOVA|||To demonstrate the non-inferiority of antibody response to the rotavirus vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen||1.61|0.76|
71146697|NCT00449696|141786517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.91||||0.122||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.|||||0.122
71146698|NCT00449696|141786518|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.42||||0.071||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.|||||0.071
71146699|NCT00449696|141786519|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.64||||0.058||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.|||||0.058
71146700|NCT00449696|141786520|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.022||95.0||||P-value for strict OMERACT-OARSI response.|Generalized Estimating Equation Model|||||||0.022
71146701|NCT00449696|141786520|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.242||95.0||||P-value for OMERACT-OARSI response.|Generalized Estimating Equation Model|||||||0.242
71146702|NCT00449696|141786521|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||P-value for physical component scores, physical function subscale, role physical subscale, and bodily pain subscale.|Wilcoxon (Mann-Whitney)|||||||>0.05
71146703|NCT00449696|141786522|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.39||||0.037||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.|||||0.037
70955356|NCT01302067|141414384|SUPERIORITY_OR_OTHER||Least squares mean difference|7.46|STANDARD_ERROR_OF_MEAN|1.56|<|0.0001|TWO_SIDED|95.0|4.4|10.51||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||10.51|4.40|<0.0001
70955357|NCT01302067|141414384|SUPERIORITY_OR_OTHER||Least squares mean difference|3.74|STANDARD_ERROR_OF_MEAN|1.27||0.0034|TWO_SIDED|95.0|1.24|6.23||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||6.23|1.24|0.0034
70955358|NCT01302067|141414384|SUPERIORITY_OR_OTHER||Least squares mean difference|3.72|STANDARD_ERROR_OF_MEAN|1.55||0.0164|TWO_SIDED|95.0|0.68|6.76||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||6.76|0.68|0.0164
70955359|NCT01302067|141414385|SUPERIORITY_OR_OTHER||Least squares mean difference|7.5|STANDARD_ERROR_OF_MEAN|1.26|<|0.0001|TWO_SIDED|95.0|5.03|9.97||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||9.97|5.03|<0.0001
70955360|NCT01302067|141414385|SUPERIORITY_OR_OTHER||Least squares mean difference|3.68|STANDARD_ERROR_OF_MEAN|1.03||0.0004|TWO_SIDED|95.0|1.65|5.7||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||5.70|1.65|0.0004
70955361|NCT01302067|141414385|SUPERIORITY_OR_OTHER||Least squares mean difference|3.82|STANDARD_ERROR_OF_MEAN|1.25||0.0023|TWO_SIDED|95.0|1.36|6.28||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||6.28|1.36|0.0023
70955362|NCT01302067|141414386|SUPERIORITY_OR_OTHER||Least squares mean difference|9.37|STANDARD_ERROR_OF_MEAN|1.43|<|0.0001|TWO_SIDED|95.0|6.56|12.18||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||12.18|6.56|<0.0001
71146704|NCT00449696|141786523|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.92||||0.746||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.|||||0.746
71146705|NCT00449696|141786524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.56||||0.166||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.|||||0.166
71146706|NCT00449696|141786525|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.041
71146707|NCT01903460|141786544|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-40.707||||0.574|TWO_SIDED|95.0|-191.679|110.265|||ANCOVA|||Analysis of LUM001 140ug/kg/day||110.265|-191.679|0.5740
71146708|NCT01903460|141786544|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-7.231||||0.9147|TWO_SIDED|95.0|-148.726|134.264|||ANCOVA|||Analysis of LUM001 280ug/kg/day||134.264|-148.726|0.9147
71146709|NCT01903460|141786544|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-23.969||||0.6954|TWO_SIDED|95.0|-151.969|104.031|||ANCOVA|||Analysis of all doses of LUM001||104.031|-151.969|0.6954
71146710|NCT01903460|141786545|SUPERIORITY_OR_OTHER||LS mean difference from placebo|56.7||||0.0783|TWO_SIDED|95.0|-7.2|120.6|||ANCOVA|||Analysis of LUM001 140ug/kg/day for ALT||120.6|-7.2|0.0783
71146711|NCT01903460|141786545|SUPERIORITY_OR_OTHER||LS mean difference from placebo|7.8||||0.7827|TWO_SIDED|95.0|-51.4|67.0|||ANCOVA|||Analysis of LUM001 280ug/kg/day for ALT||67.0|-51.4|0.7827
71146712|NCT01903460|141786545|SUPERIORITY_OR_OTHER||LS mean difference from placebo|32.2||||0.2235|TWO_SIDED|95.0|-21.9|86.3|||ANCOVA|||Analysis of all doses of LUM001 for ALT||86.3|-21.9|0.2235
71146713|NCT01903460|141786545|SUPERIORITY_OR_OTHER||LS mean difference from placebo|24.0||||0.2372|TWO_SIDED|95.0|-17.5|65.5|||ANCOVA|||Analysis of LUM001 140ug/kg/day for AST||65.5|-17.5|0.2372
71146714|NCT01903460|141786545|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-15.8||||0.3914|TWO_SIDED|95.0|-54.1|22.4|||ANCOVA|||Analysis of LUM001 280ug/kg/day for AST||22.4|-54.1|0.3914
71146715|NCT01903460|141786545|SUPERIORITY_OR_OTHER||LS mean difference from placebo|4.1||||0.8081|TWO_SIDED|95.0|-31.0|39.1|||ANCOVA|||Analysis of all doses of LUM001 for AST||39.1|-31.0|0.8081
71146716|NCT01903460|141786545|SUPERIORITY_OR_OTHER||LS mean difference from placebo|51.7||||0.5748|TWO_SIDED|95.0|-140.3|243.7|||ANCOVA|||Analysis of LUM001 140ug/kg/day for ALP||243.7|-140.3|0.5748
71146717|NCT01903460|141786545|SUPERIORITY_OR_OTHER||LS mean difference from placebo|11.9||||0.8835|TWO_SIDED|95.0|-158.4|182.2|||ANCOVA|||Analysis of LUM001 280ug/kg/day for ALP||182.2|-158.4|0.8835
71146718|NCT01903460|141786545|SUPERIORITY_OR_OTHER||LS mean difference from placebo|31.8||||0.6917|TWO_SIDED|95.0|-135.8|199.4|||ANCOVA|||Analysis of all doses of LUM001 for ALP||199.4|-135.8|0.6917
71146719|NCT01903460|141786546|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-0.348||||0.6907|TWO_SIDED|95.0|-2.468|1.772|||ANCOVA|||Analysis of LUM001 140ug/kg/day for Patient ItchRO||1.772|-2.468|0.6907
71146720|NCT01903460|141786546|SUPERIORITY_OR_OTHER||LS mean difference from placebo|0.202||||0.7897|TWO_SIDED|95.0|-1.647|2.052|||ANCOVA|||Analysis of LUM001 280ug/kg/day for Patient ItchRO||2.052|-1.647|0.7897
70955363|NCT01302067|141414386|SUPERIORITY_OR_OTHER||Least squares mean difference|4.23|STANDARD_ERROR_OF_MEAN|1.17||0.0003|TWO_SIDED|95.0|1.93|6.53||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||6.53|1.93|0.0003
71146721|NCT01903460|141786546|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-0.073||||0.9203|TWO_SIDED|95.0|-1.85|1.705|||ANCOVA|||Analysis of all doses of LUM001 for Patient ItchRO||1.705|-1.850|0.9203
71146722|NCT01903460|141786546|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-0.21||||0.5966|TWO_SIDED|95.0|-1.038|0.618|||ANCOVA|||Analysis of LUM001 140ug/kg/day for Observer ItchRO||0.618|-1.038|0.5966
71146723|NCT01903460|141786546|SUPERIORITY_OR_OTHER||LS mean difference from placebo|0.173||||0.632|TWO_SIDED|95.0|-0.58|0.926|||ANCOVA|||Analysis of LUM001 280ug/kg/day for Observer ItchRO||0.926|-0.580|0.6320
71146724|NCT01903460|141786546|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-0.019||||0.9547|TWO_SIDED|95.0|-0.71|0.673|||ANCOVA|||Analysis of all doses of LUM001 for Observer ItchRO||0.673|-0.710|0.9547
71146725|NCT05712460|141786591|OTHER||Ratio|126.65|||||TWO_SIDED|90.0|106.87|150.1|||||Analysis was performed using mixed effect model with sequence, and treatment as fixed effects and participant within sequence as a random effect.|||150.10|106.87|
71146726|NCT05712460|141786592|OTHER||Ratio|142.94|||||TWO_SIDED|90.0|117.2|174.32|||||Analysis was performed using mixed effect model with sequence, and treatment as fixed effects and participant within sequence as a random effect.|||174.32|117.20|
71146727|NCT02735863|141786601|SUPERIORITY|||||||0.5352|||||||Log Rank|||||||0.5352
71146728|NCT00829426|141786602|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% Confidence Interval falls withi 80-125.|Geometric Test/Ref Ratio x 100|102.56|||||TWO_SIDED|90.0|98.74|106.52|||||Bioequivalence is established when 90% Confidence Interval falls withi 80-125.|||106.52|98.74|
71146729|NCT00829426|141786603|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on each of the pharmacokinetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|92.88||||||90.0|90.34|95.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||95.48|90.34|
71146730|NCT00829426|141786604|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on each of the pharmacokinetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|93.92||||||90.0|91.47|96.44|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||96.44|91.47|
71146731|NCT05560425|141786606|EQUIVALENCE|"The equivalence margin is a range of the compliance score for which the independent training of skills in each group is close enough to be considered equivalent."|Mean Difference (Final Values)|1.29|STANDARD_ERROR_OF_MEAN|3.45|<|0.05|TWO_SIDED|95.0|-6.22|8.79|||t-test, 1 sided|degrees of freedom = 12||Null hypothesis: Compliance with independent training of skills is not equivalent between groups.||8.79|-6.22|<0.05
71146732|NCT02260934|141786618|SUPERIORITY|||||||0.58||||||Two-sided test|Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 0 to Week 24||||0.58
71146733|NCT02260934|141786618|SUPERIORITY|||||||0.25||||||Two-sided test.|Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 0 to Week 48||||0.25
71146734|NCT02260934|141786618|SUPERIORITY|||||||0.15||||||Two-sided test.|Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 0 to Week 96.||||0.15
71146735|NCT02260934|141786620|SUPERIORITY|P-value could not be produced because of zero count in at least one of the treatment arms.|||||||||||||Regression, Logistic|Two sided test. P-value could not be produced because of zero count in at least one of the treatment arms.||Week 0 to Week 24|Treatment group was the independent variable in the logistic regression.|||
71146736|NCT02260934|141786620|SUPERIORITY||||||||||||||Regression, Logistic|P-value could not be produced because of zero count in at least one of the treatment arms.||Week 0 to Week 48|P-value could not be produced because of zero count in at least one of the treatment arms.|||
71146737|NCT02260934|141786620|SUPERIORITY|P-value could not be produced because of zero count in at least one of the treatment arms|||||||||||||Regression, Logistic|P-value could not be produced because of zero count in at least one of the treatment arms||Week 0 to Week 96 The modified intent to treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.|P-value could not be produced because of zero count in at least one of the treatment arms|||
71146738|NCT02260934|141786621|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.66||||||Treatment group was the independent variable in the logistic regression.|Regression, Logistic|2 sided test||Week 24||||0.66
71146739|NCT02260934|141786621|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.65||||||Treatment group was the independent variable in the logistic regression.|Regression, Logistic|2 sided test||Week 48|Treatment group was the independent variable in the logistic regression.|||0.65
71146740|NCT02260934|141786622|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.64||||||2 sided test|Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 24 Treatment group was the independent variable in the logistic regression.||||0.64
71146741|NCT02260934|141786622|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.37||||||2 sided test|Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 48||||0.37
71146742|NCT02260934|141786622|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.32|||||||Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 96||||0.32
71146743|NCT02260934|141786623|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.91||||||2 sided test|Regression, Logistic|2 sided test||Week 96||||0.91
71146744|NCT02260934|141786624|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.73||||||2 sided test|Regression, Logistic|2 sided test||Week 0 to Week 24||||.73
71146745|NCT02260934|141786624|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.26||||||2 sided test|Regression, Logistic|2 sided test||Week 0 to Week 48||||0.26
70874210|NCT02254486|141233239|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|-3.01||||0.863|TWO_SIDED|95.0|-11.36|5.28||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to Trisulfate Solution with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 rate - TS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||5.28|-11.36|0.863
70874211|NCT02254486|141233240|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.||||||0.66||||||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to Trisulfate Solution with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 rate - TS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||||0.660
70874212|NCT02254486|141233241|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.||||||0.953||||||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to Trisulfate Solution with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in PDR was calculated as NER1006 rate - Trisulfate Solution rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||||0.953
70874213|NCT02254486|141233242|NON_INFERIORITY_OR_EQUIVALENCE|Formal hierarchical testing of this key secondary endpoints was not performed due to the results of the non-inferiority analysis.||||||0.781|||||||Fisher Exact|||If at least one of the alternative primary endpoints were met, then key secondary endpoints were evaluated hierarchichally in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit (CL) for difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of Trisulate Solution. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.||||0.781
70874214|NCT00356369|141233315|NON_INFERIORITY|Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was greater than (\>) -15%.|Difference in % for rSBA-MenA antibodies|13.0|||||TWO_SIDED|95.0|3.52|23.5||||||To evaluate the non-inferiority of the vaccine response\* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.||23.5|3.52|
70874215|NCT00356369|141233315|NON_INFERIORITY|Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was ≥ -12%.|Difference in % for rSBA-MenC antibodies|4.18|||||TWO_SIDED|95.0|-1.03|11.36||||||To evaluate the non-inferiority of the vaccine response\* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.||11.36|-1.03|
70874216|NCT00356369|141233315|NON_INFERIORITY|Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was ≥ -12%.|Difference in%for rSBA-MenW-135 antibody|4.58|||||TWO_SIDED|95.0|-0.07|11.49||||||To evaluate the non-inferiority of the vaccine response\* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.||11.49|-0.07|
70874217|NCT00356369|141233315|NON_INFERIORITY|Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was ≥ -12%.|Difference in % for rSBA-MenY antibodies|8.05|||||TWO_SIDED|95.0|1.72|16.17||||||To evaluate the non-inferiority of the vaccine response\* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.||16.17|1.72|
70874218|NCT00356369|141233316|NON_INFERIORITY|Criterion indicative of non-inferiority: Upper limit of the standardized asymptotic 95% CI on the difference between MenACWY- TT and (minus) MenACWY in the incidence of Grade 3 systemic symptoms was below 5%.|Difference in % Grade 3 general symptoms|1.34|||||TWO_SIDED|95.0|-1.64|3.09||||||To evaluate the non-inferiority of the MenACWY-TT conjugate vaccine when compared to the licensed MenACWY vaccine in terms of the incidence of any Grade 3 systemic symptom within 4 days after vaccination.||3.09|-1.64|
70874219|NCT03530098|141233361|SUPERIORITY||Odds Ratio (OR)|-0.59||||0.04|TWO_SIDED|95.0|-1.14|-0.04|||t-test, 2 sided|||||-0.04|-1.14|0.04
70874220|NCT03530098|141233362|OTHER|||||||0.001|||||||Wilcoxon rank-sum test|||||||0.001
70874221|NCT01606436|141233406|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.62|||||TWO_SIDED|90.0|-1.2|2.44||||||Comparison at 0.5 hours postdose.||2.44|-1.20|
70874222|NCT01606436|141233406|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.89|||||TWO_SIDED|90.0|1.05|4.73||||||Comparison at 2.0 hours postdose.||4.73|1.05|
70874223|NCT01606436|141233406|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.11|||||TWO_SIDED|90.0|0.28|3.95||||||Comparison at 3.0 hours postdose.||3.95|0.28|
70874224|NCT01606436|141233406|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.48|||||TWO_SIDED|90.0|-0.36|3.32||||||Comparison at 4.0 hours postdose.||3.32|-0.36|
70874225|NCT01606436|141233406|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.48|||||TWO_SIDED|90.0|-0.36|3.32||||||Comparison at 5.0 hours postdose.||3.32|-0.36|
71146746|NCT02260934|141786624|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.29||||||2 sided test|Regression, Logistic|2 sided test||Week 0 to Week 96||||0.29
71146747|NCT02260934|141786625|SUPERIORITY|2 sided test|||||>|0.99||||||2 sided test|Fisher Exact|2 sided test||Week 0 to Week 24||||>0.99
71146748|NCT02260934|141786626|SUPERIORITY|2 sided test||||||0.49||||||2 sided test|Fisher Exact|2 sided test||Week 0 to Week 48||||0.49
71146749|NCT02260934|141786628|SUPERIORITY|2 sided test||||||0.89||||||2 sided test|Regression, Logistic|||Treatment group was the independent variable in the logistic regression.||||0.89
71146750|NCT02260934|141786628|SUPERIORITY|Week 48||||||0.47||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||0.47
71146751|NCT02260934|141786628|SUPERIORITY|Week 96||||||0.94||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||0.94
71146752|NCT02260934|141786629|SUPERIORITY|Week 24||||||0.08||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||0.08
71146753|NCT02260934|141786629|SUPERIORITY|Week 48||||||0.11||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||0.11
71146754|NCT02260934|141786629|SUPERIORITY|Week 96||||||0.05||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||0.05
71146755|NCT02260934|141786630|SUPERIORITY|Week 24||||||0.2||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||.20
71146756|NCT02260934|141786630|SUPERIORITY|Week 48|||||>|0.99||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||>0.99
71146757|NCT02260934|141786630|SUPERIORITY|Week 96||||||0.63||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||0.63
71146758|NCT03605667|141786633|SUPERIORITY|Unstructure covariance structure.|Least square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.93||0.9809|TWO_SIDED|95.0|-1.8|1.8|||Mixed model with repeated measures|||Model based summary statistics are from a mixed model with repeated measures, including fixed effects for pooled site ID, treatment, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction, mini-mental state examination (MMSE) randomization stratification, apolipoprotein E (APoE) status (carrier/non carrier), as covariates, and repeated measures for visit within participant.||1.8|-1.8|0.9809
71146759|NCT03605667|141786634|SUPERIORITY|Unstructure covariance structure.|Least square mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.4474|TWO_SIDED|95.0|-0.8|0.3|||Mixed model with repeated measures|||Model based summary statistics are from a mixed model with repeated measures, including fixed effects for pooled site ID, treatment, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction, MMSE randomization stratification, APoE status (carrier/non carrier), as covariates, and repeated measures for visit within participant.||0.3|-0.8|0.4474
71146760|NCT03605667|141786635|SUPERIORITY|Unstructure covariance structure.|Least square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.867|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||Model based summary statistics were from an analysis of covariance (ANCOVA) with baseline MMSE total score as covariate.||0.5|-0.6|0.8670
71146761|NCT03605667|141786636|SUPERIORITY|Unstructure covariance structure.|Least square mean difference|1.6|STANDARD_ERROR_OF_MEAN|1.21||0.195|TWO_SIDED|95.0|-0.8|3.9|||Mixed model with repeated measures|||Model based summary statistics are from a mixed model with repeated measures, including fixed effects for pooled site ID, treatment, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction, MMSE randomization stratification, APOE status (carrier/non-carrier), as covariates, and repeated measures for visit within participant.||3.9|-0.8|0.1950
71146762|NCT03605667|141786637|SUPERIORITY|Unstructure covariance structure.|Least square mean difference|1.5|STANDARD_ERROR_OF_MEAN|1.31||0.2583|TWO_SIDED|95.0|-1.1|4.1|||Mixed model with repeated measures|||Model based summary statistics are from a mixed model with repeated measures, including fixed effects for pooled site ID, treatment, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction, MMSE randomization stratification, APOE status (carrier/non-carrier), as covariates, and repeated measures for visit within participant.||4.1|-1.1|0.2583
71146763|NCT03605667|141786638|SUPERIORITY|Unstructure covariance structure.|Least square mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.48||0.4191|TWO_SIDED|95.0|-0.6|1.3|||Mixed model with repeated measures|||Model based summary statistics are from a mixed model with repeated measures, including fixed effects for pooled site ID, treatment, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction, MMSE randomization stratification, APOE status (carrier/non-carrier), as covariates, and repeated measures for visit within participant.||1.3|-0.6|0.4191
71146764|NCT03605667|141786640|SUPERIORITY||Least square mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.38||0.224|TWO_SIDED|95.0|-1.2|0.3|||ANCOVA|||Model based summary statistics are from an ANCOVA with baseline MMSE total score as covariate.||0.3|-1.2|0.2240
71146765|NCT03605667|141786641|SUPERIORITY|||||||0.0161|||||||Fisher Exact|||||||0.0161
71146766|NCT02867436|141786658|SUPERIORITY||Mean Difference (Final Values)|205.0|||<|0.05|TWO_SIDED|95.0|-223.0|633.0|||Regression, Linear|||||633|-223|<0.05
71146767|NCT02867436|141786659|SUPERIORITY||Mean Difference (Final Values)|-7.8|||<|0.05|TWO_SIDED|95.0|-14.1|-1.6|||Regression, Linear|||||-1.6|-14.1|<0.05
71146768|NCT02867436|141786660|SUPERIORITY||Mean Difference (Final Values)|-0.15|||<|0.05|TWO_SIDED|95.0|-0.31|0.01|||Regression, Linear|||||0.01|-0.31|<0.05
71146769|NCT02867436|141786661|SUPERIORITY||||||<|0.05|||||||t-test, 1 sided|||||||<0.05
71146770|NCT02867436|141786662|SUPERIORITY||||||<|0.05||||||After Benjamini-Hochberg correction for multiple comparisons|ANOVA|||||||<0.05
71146771|NCT05720897|141786759|SUPERIORITY|||||||0.399||||||The calculations are based on a Mann Whitney calculation.|Wilcoxon (Mann-Whitney)|||The study has an 80% power to detect changes in patient's self-reported anxiety as measured by their responses to the psychometrically validated STAI-S \& T instrument of 3.6 within each group (with an effect size of 0.55) and differences of a 5.0 between groups (with an effect size of 0.77).||||.399
71146772|NCT00400179|141786765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3952||95.0|||||Fisher Exact|||||||0.3952
71146773|NCT00400179|141786766|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.0808|TWO_SIDED|95.0|0.57|1.03|||Log Rank|||||1.03|0.57|0.0808
70955364|NCT01302067|141414386|SUPERIORITY_OR_OTHER||Least squares mean difference|5.14|STANDARD_ERROR_OF_MEAN|1.43||0.0003|TWO_SIDED|95.0|2.34|7.94||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||7.94|2.34|0.0003
70955365|NCT01302067|141414387|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.||||0.0016
70955366|NCT01302067|141414387|SUPERIORITY_OR_OTHER|||||||0.8121|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.||||0.8121
70955367|NCT01302067|141414387|SUPERIORITY_OR_OTHER|||||||0.0015|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.||||0.0015
70955368|NCT01302067|141414388|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.||||<0.0001
70955369|NCT01302067|141414388|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.||||0.0006
71146774|NCT00400179|141786767|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99||||0.9158|TWO_SIDED|95.0|0.86|1.14|||Log Rank|||||1.14|0.86|0.9158
71146775|NCT00400179|141786768|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.032|TWO_SIDED|95.0|0.77|0.99|||Log Rank|||||0.99|0.77|0.0320
71146776|NCT00400179|141786769|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92||||0.1983|TWO_SIDED|95.0|0.8|1.05|||Log Rank|||||1.05|0.80|0.1983
71146777|NCT04780061|141786770|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||An area under the curve approach was used to analyze the primary outcome, whereby participants' scores for each assessment were summed over the 21-day period. For missing values, we imputed the mean of the most recent and first subsequent measurement or carried the last observation forward if there was no subsequent measurement.||||0.53
70955370|NCT01302067|141414388|SUPERIORITY_OR_OTHER|||||||0.0027|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.||||0.0027
70955371|NCT00591721|141414433|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.53|STANDARD_DEVIATION|6.47|<|0.05|TWO_SIDED|95.0|-15.47|10.41|||t-test, 2 sided|Each baseline subscale score was subtracted from 7 week subscale score; t-tests assessed mean individual differences between groups.||Hypothesis: Individuals who participate in the program will report significantly reduced fatigue impact immediately post-intervention compared to individuals allocated to the wait-list control group.||10.41|-15.47|<0.05
70955372|NCT02716818|141414443|SUPERIORITY||Mean Difference (Final Values)|-0.069|||=|0.5521|TWO_SIDED|95.0|-0.299|0.161|||ANCOVA|||The primary efficacy variable was the natural logarithm of the mean of the 24-hour SDS profile for the natural logarithm of 17-OHP. The SDS profile was calculated as the SDS of log transformed 17-OHP concentration unsigned. The mean of the 24-hour SDS profile for each visit was the arithmetic mean of all the SDSs, with the first and last (13th) weighted one half relative to the intermediate SDSs.||0.161|-0.299|=0.5521
71146778|NCT04780061|141786772|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
70955373|NCT02716818|141414444|SUPERIORITY||Mean Difference (Final Values)|0.047|||=|0.7405|TWO_SIDED|95.0|-0.234|0.329|||ANCOVA|||Change from Baseline to 24 Weeks in A4 Using an ANCOVA Model - The analysis conducted for the primary endpoint variable analysis of 17-OHP was repeated for A4.||0.329|-0.234|=0.7405
71146779|NCT04780061|141786773|SUPERIORITY|||||||0.81|||||||Log Rank|||||||0.81
71146780|NCT00303069|141786779|SUPERIORITY_OR_OTHER||Risk Difference (RD)|84.5|||<|0.001|TWO_SIDED|95.0|65.2|93.6||P-value \< 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (\<40 yrs, ≥40 yrs)|Risk Difference is 90 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.||93.6|65.2|<0.001
71146781|NCT00303069|141786779|SUPERIORITY_OR_OTHER||Risk Difference (RD)|81.6|||<|0.01|TWO_SIDED|95.0|61.6|92.0||P-value \< 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (\<40 yrs, ≥40 yrs)|Risk Difference is 30 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.||92.0|61.6|<0.01
70955374|NCT02716818|141414445|SUPERIORITY||Mean Difference (Final Values)|-0.037|||=|0.8186|TWO_SIDED|95.0|-0.354|0.281|||ANCOVA|||||0.281|-0.354|=0.8186
70955375|NCT02716818|141414445|SUPERIORITY||Mean Difference (Final Values)|-0.135|||=|0.4655|TWO_SIDED|95.0|-0.508|0.237|||ANCOVA|||||0.237|-0.508|=0.4655
70955376|NCT02716818|141414445|SUPERIORITY||Mean Difference (Final Values)|0.065|||=|0.9081|TWO_SIDED|95.0|-1.32|1.451|||ANCOVA|||||1.451|-1.32|=0.9081
70955377|NCT02716818|141414445|SUPERIORITY||Median Difference (Final Values)|0.092|||=|0.6729|TWO_SIDED|95.0|-0.343|0.527|||ANCOVA|||||0.527|-0.343|=0.6729
70955378|NCT02716818|141414445|SUPERIORITY||Mean Difference (Final Values)|0.116|||=|0.5322|TWO_SIDED|95.0|-0.257|0.489|||ANCOVA|||||0.489|-0.257|=0.5322
70955379|NCT02716818|141414445|SUPERIORITY||Mean Difference (Final Values)|-0.568|||=|0.2885|TWO_SIDED|95.0|-1.799|0.662|||ANCOVA|||||0.662|-1.799|=0.2885
70955380|NCT02716818|141414446|SUPERIORITY||Odds Ratio (OR)|0.99|||=|0.9877|TWO_SIDED|95.0|0.45|2.19|||Regression, Logistic|||||2.19|0.45|=0.9877
70955381|NCT02716818|141414446|SUPERIORITY||Odds Ratio (OR)|0.93|||=|0.8498|TWO_SIDED|95.0|0.43|2.02|||Regression, Logistic|||||2.02|0.43|=0.8498
70955382|NCT02716818|141414447|SUPERIORITY||Mean Difference (Final Values)|-0.96|||=|0.156|TWO_SIDED|95.0|-2.294|0.374|||ANCOVA|||German subjects have been excluded from this analysis group as DEXA scans are not performed at German sites.||0.374|-2.294|=0.156
70955383|NCT02716818|141414447|SUPERIORITY||Median Difference (Final Values)|0.425|||=|0.3392|TWO_SIDED|95.0|-0.455|1.305|||ANCOVA|||German subjects have been excluded from this analysis group as DEXA scans are not performed at German sites.||1.305|-0.455|=0.3392
70955384|NCT02716818|141414448|SUPERIORITY||Median Difference (Final Values)|0.009|||=|0.2614|TWO_SIDED|95.0|-0.007|0.025|||ANCOVA|||||0.025|-0.007|=0.2614
71146782|NCT00303069|141786779|SUPERIORITY_OR_OTHER||Risk Difference (RD)|25.0|||<|0.001|TWO_SIDED|95.0|6.7|43.8||P-value \< 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (\<40 yrs, ≥40 yrs)|Risk Difference is 5 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.||43.8|6.7|<0.001
71146783|NCT00303069|141786780|SUPERIORITY_OR_OTHER||Risk Difference (RD)|30.9|||<|0.001|TWO_SIDED|95.0|17.2|48.3||P-value \< 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (\<40 yrs, ≥40 yrs)|Risk Difference is 90 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.||48.3|17.2|<0.001
71146784|NCT00303069|141786780|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.4|||<|0.001|TWO_SIDED|95.0|1.6|32.1||P-value \< 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (\<40 yrs, ≥40 yrs)|Risk Difference is 30 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.||32.1|1.6|<0.001
71146785|NCT00303069|141786780|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.5|||<|0.001|TWO_SIDED|95.0|-8.2|16.9||P-value \< 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (\<40 yrs, ≥40 yrs)|Risk Difference is 5 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.||16.9|-8.2|<0.001
71146786|NCT02958917|141786788|SUPERIORITY||Mean Difference (Final Values)|-0.76|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
71146787|NCT02958917|141786789|SUPERIORITY||Cox Proportional Hazard|0.264|||<|0.05|TWO_SIDED|95.0|||||Regression, Cox|||||||<0.05
71146788|NCT02958917|141786790|SUPERIORITY||Slope|2.03|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
71146789|NCT02958917|141786791|SUPERIORITY||Median Difference (Final Values)|-0.108|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
71146790|NCT02958917|141786792|SUPERIORITY||Risk Difference (RD)|0.364|||<|0.05|TWO_SIDED||||||Log Rank|||||||<0.05
71146791|NCT02958917|141786793|SUPERIORITY||Risk Difference (RD)|0.128|||<|0.05|TWO_SIDED|95.0|||||Log Rank|||||||<0.05
71146792|NCT02958917|141786794|SUPERIORITY||Mean Difference (Final Values)|-2.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
71146793|NCT02958917|141786795|SUPERIORITY||Mean Difference (Final Values)|-6.72|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
71146794|NCT02958917|141786796|SUPERIORITY||Mean Difference (Final Values)|-4.92|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
71146795|NCT02958917|141786797|SUPERIORITY||Mean Difference (Final Values)|-7.92|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
71146796|NCT02958917|141786798|SUPERIORITY||Mean Difference (Final Values)|-2.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
71146797|NCT02318706|141786799|SUPERIORITY|DS-5565 20 mg and 30 mg are tested against placebo at significance level of 0.025, respectively. If both arms are statistically significant, DS-5565 15 mg arm will be tested at level of 0.05. If neither of the arms is statistically significant, DS-5565 15 mg arm is no longer tested. If either DS-5565 20 mg or DS-5565 30 mg is statistically significant, DS-5565 15 mg arm is tested at level of 0.025.|Hazard Ratio (HR)|-0.03||||0.8773|TWO_SIDED|95.0|-0.35|0.3|||Mixed Models Analysis|||Week 14 change from baseline||0.30|-0.35|0.8773
71146798|NCT02318706|141786799|SUPERIORITY|DS-5565 20 mg and 30 mg are tested against placebo at significance level of 0.025, respectively. If both arms are statistically significant, DS-5565 15 mg arm will be tested at level of 0.05. If neither of the arms is statistically significant, DS-5565 15 mg arm is no longer tested. If either DS-5565 20 mg or DS-5565 30 mg is statistically significant, DS-5565 15 mg arm is tested at level of 0.025.|Hazard Ratio (HR)|-0.15||||0.3494|TWO_SIDED|95.0|-0.48|0.17|||Mixed Models Analysis|||Week 14 change from baseline||0.17|-0.48|0.3494
70955385|NCT00581555|141414460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|7.5||0.999|TWO_SIDED|95.0|-14.7|14.7||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.||Analysis at randomization to Week 8.||14.7|-14.7|0.999
70955386|NCT00581555|141414460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|7.5||0.795|TWO_SIDED|95.0|-12.8|16.7||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.||Analysis at randomization to Week 10.||16.7|-12.8|0.795
70955387|NCT00581555|141414460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|7.6||0.758|TWO_SIDED|95.0|-12.5|17.1||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.||Analysis at randomization to Week 12.||17.1|-12.5|0.758
70955388|NCT00581555|141414460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|STANDARD_ERROR_OF_MEAN|7.6||0.381|TWO_SIDED|95.0|-8.3|21.6||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.||Analysis at randomization to Week 16.||21.6|-8.3|0.381
70955389|NCT00581555|141414460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.1|STANDARD_ERROR_OF_MEAN|7.8||0.041|TWO_SIDED|95.0|0.8|31.4||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis at randomization to Week 20.||31.4|0.8|0.041
71146799|NCT02318706|141786799|SUPERIORITY|DS-5565 20 mg and 30 mg are tested against placebo at significance level of 0.025, respectively. If both arms are statistically significant, DS-5565 15 mg arm will be tested at level of 0.05. If neither of the arms is statistically significant, DS-5565 15 mg arm is no longer tested. If either DS-5565 20 mg or DS-5565 30 mg is statistically significant, DS-5565 15 mg arm is tested at level of 0.025.|Hazard Ratio (HR)|-0.5||||0.0027|TWO_SIDED|95.0|-0.82|-0.17|||Mixed Models Analysis|||Week 14 change from baseline||-0.17|-0.82|0.0027
71146800|NCT01456039|141786802|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Based on one sample binomial test for dichotomized response proportion against the null hypothesis ( H0 p≤0.1)|Binomial test for dichotomized response|||||||<0.0001
71146801|NCT00335777|141786833|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|2 sided McNemar test||||||0.289|TWO_SIDED|95.0|||||McNemar|2 sided McNemar||Null hypothesis: there is no difference in the proportion of subjects who were pain free when treating early, as compared to treating late.||||0.289
71146802|NCT00335777|141786834|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|2 sided McNemar test||||||1|||||||McNemar|2 sided McNemar test||Null hypothesis: there is no difference in the proportion of subjects who had pain relief when treating early, as compared to treating late.||||1.000
71146803|NCT02798627|141786835|SUPERIORITY||||||=|0.97|||||||Chi-squared|||||||=0.97
71146804|NCT03821402|141786841|SUPERIORITY|||||||0.7645|||||||ANCOVA|||||||0.7645
71146805|NCT03821402|141786841|SUPERIORITY|||||||0.5509|||||||ANCOVA|||||||0.5509
71146806|NCT03821402|141786841|SUPERIORITY|||||||0.0488|||||||ANCOVA|||||||0.0488
71146807|NCT03821402|141786842|SUPERIORITY|||||||0.3698|||||||ANCOVA|||||||0.3698
71146808|NCT03821402|141786842|SUPERIORITY|||||||0.1972|||||||ANCOVA|||||||0.1972
71146809|NCT03821402|141786842|SUPERIORITY|||||||0.2037|||||||ANCOVA|||||||0.2037
71146810|NCT03821402|141786847|SUPERIORITY|||||||0.4324|||||||ANCOVA|||||||0.4324
71146811|NCT03821402|141786847|SUPERIORITY|||||||0.3893|||||||ANCOVA|||||||0.3893
71146812|NCT03821402|141786847|SUPERIORITY|||||||0.0002|||||||ANCOVA|||||||0.0002
71146813|NCT03821402|141786848|SUPERIORITY|||||||0.0562|||||||ANCOVA|||||||0.0562
71146814|NCT03821402|141786848|SUPERIORITY|||||||0.015|||||||ANCOVA|||||||0.0150
71146815|NCT03821402|141786848|SUPERIORITY|||||||0.0092|||||||ANCOVA|||||||0.0092
71146816|NCT03181932|141786883|SUPERIORITY|The primary efficacy endpoint was tested sequentially at Week 4 (end of Cycle 1), Week 12 (end of Cycle 2) and at Week 20 (end of Cycle 3). If a statistically significant difference was observed in favor of vancomycin inhalation powder compared to placebo after Cycle 1, then the mean change in the FEV1 percent predicted during Cycle 2 was to be tested. Similarly, if the effect after Cycle 2 was statistically significant, then the analysis of Baseline to end of Cycle 3 was to be tested.|Least square mean difference|1.4||||0.325|TWO_SIDED|95.0|-1.4|4.1|||Mixed Models Analysis|||Based on previous experience, a sample size of 45 participants per arm would provide 89% power to detect a statistically significant difference at alpha level of 0.05. To account for potential dropouts and/or smaller effect size in a 3-cycle trial, a sample size of 75 participants per arm was to be enrolled in the primary analysis population, which if all completed would provide 90% power to detect a difference of 3.4% at 20 weeks assuming the same standard deviation of 6.3%.||4.1|-1.4|0.325
71146817|NCT02220920|141786891|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-1.33|-0.87|||ANCOVA|||||-0.87|-1.33|<0.001
71146818|NCT02220920|141786892|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-32.6|STANDARD_ERROR_OF_MEAN|6.9|<|0.001|TWO_SIDED|95.0|-46.3|-18.9|||ANCOVA|||||-18.9|-46.3|<0.001
71146819|NCT02220920|141786893|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.37|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-3.09|-1.65|||ANCOVA|||||-1.65|-3.09|<0.001
71146820|NCT02220920|141786894|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.19|STANDARD_ERROR_OF_MEAN|1.67||0.058|TWO_SIDED|95.0|-6.49|0.11|||ANCOVA||Estimated P-Value, Least-Squares Mean Difference, Standard Error of the mean, 95% CI are presented for the change from Baseline in systolic blood pressure for week 16.|||0.11|-6.49|0.058
71146821|NCT02220920|141786894|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|1.03||0.232|TWO_SIDED|95.0|-3.27|0.8|||ANCOVA||Estimated P-Value, Least-Squares Mean Difference, Standard Error of the mean, 95% CI are presented for the change from Baseline in diastolic blood pressure for week 16.|||0.80|-3.27|0.232
71146822|NCT04723056|141786911|OTHER|||||||0.282||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 8||||0.282
70874226|NCT01606436|141233406|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.48|||||TWO_SIDED|90.0|1.64|5.32||||||Comparison at 6.0 hours postdose.||5.32|1.64|
70874227|NCT01606436|141233406|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.12|||||TWO_SIDED|90.0|0.27|3.97||||||Comparison at 8.0 hours postdose.||3.97|0.27|
70874228|NCT01606436|141233406|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.67|||||TWO_SIDED|90.0|-0.17|3.51||||||Comparison at 12.0 hours postdose.||3.51|-0.17|
70874229|NCT01606436|141233406|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.01|||||TWO_SIDED|90.0|-1.57|3.59||||||Comparison at 0.5 hours postdose.||3.59|-1.57|
70874230|NCT01606436|141233406|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.99|||||TWO_SIDED|90.0|2.4|7.57||||||Comparison at 2.0 hours postdose.||7.57|2.40|
70874231|NCT01606436|141233406|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.28|||||TWO_SIDED|90.0|3.71|8.86||||||Comparison at 3.0 hours postdose.||8.86|3.71|
70874232|NCT01606436|141233406|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.35|||||TWO_SIDED|90.0|3.78|8.93||||||Comparison at 4.0 hours postdose.||8.93|3.78|
70874233|NCT01606436|141233406|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.71|||||TWO_SIDED|90.0|2.11|7.31||||||Comparison at 12.0 hours postdose.||7.31|2.11|
70955390|NCT00581555|141414460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.5|STANDARD_ERROR_OF_MEAN|8.0|<|0.001|TWO_SIDED|95.0|14.8|46.3||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.||Analysis at randomization to Week 24.||46.3|14.8|<0.001
71146823|NCT04723056|141786912|OTHER|||||||0.217||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||0.217
71146824|NCT04723056|141786913|OTHER|||||||0.462||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 8||||0.462
71146825|NCT04723056|141786913|OTHER|||||||0.179||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||0.179
71146826|NCT04723056|141786914|OTHER|||||||0.573||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 8||||.573
71146827|NCT04723056|141786914|OTHER|||||||0.606||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||.606
71146828|NCT04723056|141786915|OTHER|||||||0.181||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||.181
71146829|NCT04723056|141786916|OTHER|||||||0.407||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||.407
71146830|NCT04723056|141786917|OTHER|||||||0.643||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||.643
71146831|NCT04723056|141786918|OTHER|||||||0.625||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 8||||.625
71146832|NCT04723056|141786918|OTHER|||||||0.707||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||.707
71146833|NCT00837434|141786972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|TWO_SIDED||||||ANCOVA|P-value for testing treatment effect uses week 12 CD27+ switched memory as the outcome variable and adjusts for baseline CD27+ switched memory||Null Hypothesis: Mean percentage of CD27+ switched memory cells in the peripheral blood at Week 12 does not differ between individuals treated with etanercept and those treated with adalimumab after adjusting for baseline CD27+ switched memory cells. Alt. hypothesis: Mean percentage of CD27+ switched memory cells in the peripheral blood at Week 12 in individuals treated with etanercept is lower than in those treated with adalimumab after adjusting for baseline CD27+ switched memory cells.||||0.3
71146834|NCT01122238|141786979|SUPERIORITY_OR_OTHER|||||||0.665|TWO_SIDED||||||ANCOVA|The mean values tested and reported consist of residualized change scores from the ANCOVA.||The ANCOVA model included intervention main effects and intervention interactions plus baseline cigarettes per day, education, race, and time to first daily cigarette as covariates. Intervention main effects included Nicotine Patch vs. No Nicotine Patch; Nicotine Gum vs. No Nicotine Gum; Smoking Reduction vs. No Smoking Reduction; and Motivational Interviewing vs. No Motivational Interviewing.||||.665
71146835|NCT01122238|141786979|SUPERIORITY_OR_OTHER|||||||0.562|TWO_SIDED||||||ANCOVA|The mean values tested and reported consist of residualized change scores from the ANCOVA.||The ANCOVA model included intervention main effects and intervention interactions plus baseline cigarettes per day, education, race, and time to first daily cigarette as covariates. Intervention main effects included Nicotine Patch vs. No Nicotine Patch; Nicotine Gum vs. No Nicotine Gum; Smoking Reduction vs. No Smoking Reduction; and Motivational Interviewing vs. No Motivational Interviewing.||||.562
71146836|NCT01122238|141786979|SUPERIORITY_OR_OTHER|||||||0.536|TWO_SIDED||||||ANCOVA|The mean values tested and reported consist of residualized change scores from the ANCOVA.||The ANCOVA model included intervention main effects and intervention interactions plus baseline cigarettes per day, education, race, and time to first daily cigarette as covariates. Intervention main effects included Nicotine Patch vs. No Nicotine Patch; Nicotine Gum vs. No Nicotine Gum; Smoking Reduction vs. No Smoking Reduction; and Motivational Interviewing vs. No Motivational Interviewing.||||.536
71146837|NCT01122238|141786979|SUPERIORITY_OR_OTHER|||||||0.206|TWO_SIDED||||||ANCOVA|The mean values tested and reported consist of residualized change scores from the ANCOVA.||The ANCOVA model included intervention main effects and intervention interactions plus baseline cigarettes per day, education, race, and time to first daily cigarette as covariates. Intervention main effects included Nicotine Patch vs. No Nicotine Patch; Nicotine Gum vs. No Nicotine Gum; Smoking Reduction vs. No Smoking Reduction; and Motivational Interviewing vs. No Motivational Interviewing.||||.206
71146838|NCT01122238|141786980|SUPERIORITY_OR_OTHER||Standardized Regression Coefficient|0.0||||0.98|TWO_SIDED||||||Regression, Linear|||The linear regression model effects consisted of four treatment main effects, six two-way treatment interactions, four three-way treatment interactions, and one four-way interaction. Only the results for the treatment main effects are being reported in ClinicalTrials.gov.||||.98
71146839|NCT01122238|141786980|SUPERIORITY_OR_OTHER||Standardized Regression Coefficient|-0.04||||0.4|TWO_SIDED||||||Regression, Linear|||The linear regression model effects consisted of four treatment main effects, six two-way treatment interactions, four three-way treatment interactions, and one four-way interaction. Only the results for the treatment main effects are being reported in ClinicalTrials.gov.||||.40
71146840|NCT01122238|141786980|SUPERIORITY_OR_OTHER||Standardized Regression Coefficient|0.0||||0.99|TWO_SIDED||||||Regression, Linear|||The linear regression model effects consisted of four treatment main effects, six two-way treatment interactions, four three-way treatment interactions, and one four-way interaction. Only the results for the treatment main effects are being reported in ClinicalTrials.gov.||||.99
71146841|NCT01122238|141786980|SUPERIORITY_OR_OTHER||Standardized Regression Coefficient|-0.04||||0.33|TWO_SIDED||||||Regression, Linear|||The linear regression model effects consisted of four treatment main effects, six two-way treatment interactions, four three-way treatment interactions, and one four-way interaction. Only the results for the treatment main effects are being reported in ClinicalTrials.gov.||||.33
70955391|NCT00581555|141414461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.3||0.049|TWO_SIDED|95.0|0.0|1.2||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from randomization to Week 24.||1.2|0.0|0.049
70955392|NCT00581555|141414462|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|Pearson chi-square|Treatment groups and visits were fixed factors with a logit link, a binomial distribution and an auto-regressive correlation structure.||Analysis from randomization to Week 24.||||0.002
71146842|NCT02224560|141787032|SUPERIORITY||Median Difference (Final Values)|-21.57||||0.0047|TWO_SIDED|95.0|-34.79|-6.67|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach|||-6.67|-34.79|0.0047
71146843|NCT02224560|141787032|SUPERIORITY||Median Difference (Final Values)|-19.19||||0.0016|TWO_SIDED|95.0|-31.24|-7.69|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach|||-7.69|-31.24|0.0016
71146844|NCT02224560|141787033|SUPERIORITY||Odds Ratio (OR)|3.85||||0.0006|TWO_SIDED|95.0|1.75|8.47||Calculated using a Cochran-Mantel-Haenszel (CMH) test stratified by age group (2-5, 6-11, 12-17 and 18-55 years)|Cochran-Mantel-Haenszel|||||8.47|1.75|0.0006
71146845|NCT02224560|141787033|SUPERIORITY||Odds Ratio (OR)|3.27||||0.003|TWO_SIDED|95.0|1.47|7.26||Calculated using a CMH test stratified by age group (2-5, 6-11, 12-17 and 18-55 years)|Cochran-Mantel-Haenszel|||||7.26|1.47|0.0030
71146846|NCT02224560|141787034|SUPERIORITY||Median Difference (Final Values)|-18.76||||0.0091|TWO_SIDED|95.0|-31.8|-4.43|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach|||-4.43|-31.80|0.0091
70874234|NCT01025752|141233414|NON_INFERIORITY|A 20% (1.4) reduction in NRS for pain intensity from baseline was considered minimally clinically important the non-inferiority margin was set at one NRS unit. The required sample size was 230 participants. Because enrollment was slower than expected and the standard deviation in the primary outcome was less than the initial power calculation (1.6 vs. 2.45) we conducted a sample size recalculation, based on observed data to determine that we would need 42 completers per arm for 80% power.|Mean Difference (Final Values)|0.07||||0.007|TWO_SIDED|95.0|-0.67|0.8||Non-inferiority margin of 1|Mixed Models Analysis|The models includes treatment arm, time, treatment-by-time interaction, baseline NRS, stratification variables (distance from VA \& back pain cause)|The upper limit (0.80) fell below the non-inferiority margin of 1.|post-treatment (12 weeks) time point||0.80|-0.67|0.007
70955393|NCT00581555|141414463|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||Log Rank|Time to first relapse was estimated using the Kaplan-Meier's, and comparisons between groups was performed using log rank tests.||||||0.0003
71146847|NCT02224560|141787034|SUPERIORITY||Median Difference (Final Values)|-19.47||||0.0015|TWO_SIDED|95.0|-30.37|-7.47|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach|||-7.47|-30.37|0.0015
71146848|NCT02224560|141787035|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0439|TWO_SIDED|95.0|1.02|3.3|||Regression, Logistic|Ordinal logistic regression model with treatment group as a fixed factor|Odds of participant recording a lower score (improvement) on a continuous scale|||3.30|1.02|0.0439
71146849|NCT02224560|141787035|SUPERIORITY||Odds Ratio (OR)|2.57||||0.002|TWO_SIDED|95.0|1.41|4.66|||Regression, Logistic|Ordinal logistic regression model with treatment group as a fixed factor|Odds of participant recording a lower score (improvement) on a continuous scale|||4.66|1.41|0.0020
71146850|NCT03165617|141787036|SUPERIORITY|Success criterion were met as the LL of the 2-sided 95% CI was above 20%.|Absolute Efficacy|54.63|||||TWO_SIDED|95.0|45.67|62.12||||||Statistical Analysis title - Absolute Vaccine Efficacy Any Strain. Adjusted aVE for QIVc vs. comparator. Success criteria for the primary efficacy endpoint was met if the LL of the 2-sided 95% CI of the aVE estimate was greater than 20% (primary endpoint) using the protocol definition of ILI for the entire age range (2 to \<18 years of age).||62.12|45.67|
70955394|NCT00581555|141414464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|2.1|7.3||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from randomization to Week 24.||7.3|2.1|<0.001
71146851|NCT03165617|141787037|SUPERIORITY|Success criteria was met as the LL of the 2-sided 95% CI of the VE estimate was greater than 30% (co-primary endpoint)|Absolute Vaccine Efficacy|54.03|||||TWO_SIDED|95.0|44.8|61.71||||||Statistical analysis title - Absolute Vaccine Efficacy, Any Strain Adjusted aVE for QIVc vs. comparator. Success criteria for the primary efficacy endpoint was met if the LL of the 2-sided 95% CI of the aVE estimate was greater than 30% (co-primary endpoint) using the protocol definition of ILI for the entire age range (≥ 3 to \<18 years of age).||61.71|44.8|
71146852|NCT03165617|141787038|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<18 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|54.63|||||TWO_SIDED|95.0|45.67|62.12||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<18yrs||62.12|45.67|
71146853|NCT03165617|141787038|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<9 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|50.51|||||TWO_SIDED|95.0|38.43|60.22||||||Statistical analysis title: Absolute Vaccine Efficacy, Any Strain, 2 to \<9yrs||60.22|38.43|
71146854|NCT03165617|141787038|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 4 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|53.33|||||TWO_SIDED|95.0|43.38|61.54||||||Statistical analysis title: Absolute Vaccine Efficacy, Any Strain, 4 to \<18yrs||61.54|43.38|
71146855|NCT03165617|141787038|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 9 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|61.85|||||TWO_SIDED|95.0|47.37|72.34||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 9 to \<18yrs||72.34|47.37|
70955395|NCT00581555|141414465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|135.2|STANDARD_ERROR_OF_MEAN|42.3||0.001|TWO_SIDED|95.0|52.3|218.1||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from randomization to Week 24.||218.1|52.3|0.001
71146856|NCT03165617|141787039|SUPERIORITY|Absolute Vaccine Efficacy (aVE) for 2 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints|Absolute Vaccine Efficacy|54.63|||||TWO_SIDED|95.0|45.67|62.12||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<18yrs||62.12|45.67|
70955396|NCT00581555|141414466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|1.6||0.139||95.0|-0.8|5.5||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from randomization to Week 24.||5.5|-0.8|0.139
70955397|NCT00581555|141414467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|1.2||0.956|TWO_SIDED|95.0|-2.3|2.5||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 2.||2.5|-2.3|0.956
70955398|NCT00581555|141414467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|1.3||0.41|TWO_SIDED|95.0|-3.6|1.5||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 4.||1.5|-3.6|0.41
70955399|NCT00581555|141414467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|2.2||0.844|TWO_SIDED|95.0|-4.8|3.9||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 6.||3.9|-4.8|0.844
70955400|NCT00581555|141414467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.9||0.968|TWO_SIDED|95.0|-1.8|1.8||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 8.||1.8|-1.8|0.968
71146857|NCT03165617|141787039|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<9 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|60.78|||||TWO_SIDED|95.0|49.01|69.83||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<9yrs||69.83|49.01|
71146858|NCT03165617|141787039|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 4 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|59.66|||||TWO_SIDED|95.0|49.08|68.05||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 4 to \<18yrs||68.05|49.08|
71146859|NCT03165617|141787039|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 9 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|60.72|||||TWO_SIDED|95.0|42.14|73.33||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 9 to \<18yrs||73.33|42.14|
71146860|NCT03165617|141787040|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<18 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|60.81|||||TWO_SIDED|95.0|51.3|68.46||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<18yrs||68.46|51.3|
71146861|NCT03165617|141787040|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<9 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|60.78|||||TWO_SIDED|95.0|49.01|69.83||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<9yrs||69.83|49.01|
71146862|NCT03165617|141787040|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 9 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|59.66|||||TWO_SIDED|95.0|49.08|68.05||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 9 to \<18yrs||68.05|49.08|
71146863|NCT03165617|141787040|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 9 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|60.72|||||TWO_SIDED|95.0|42.14|73.33||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 9 to \<18yrs||73.33|42.14|
71146864|NCT03165617|141787041|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<18 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|63.64|||||TWO_SIDED|95.0|53.64|71.48||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<18yrs||71.48|53.64|
70955401|NCT00581555|141414467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.9||0.441|TWO_SIDED|95.0|-1.1|2.5||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 10.||2.5|-1.1|0.441
70955402|NCT00581555|141414467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.9||0.3|TWO_SIDED|95.0|-0.9|2.8||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 12.||2.8|-0.9|0.3
70874235|NCT01025752|141233414|NON_INFERIORITY|A 20% (1.4) reduction in NRS for pain intensity from baseline was considered minimally clinically important the non-inferiority margin was set at one NRS unit. The required sample size was 230 participants. Because enrollment was slower than expected and the standard deviation in the primary outcome was less than the initial power calculation (1.6 vs. 2.45) we conducted a sample size recalculation, based on observed data to determine that we would need 42 completers per arm for 80% power.|Mean Difference (Final Values)|-0.23|||<|0.0001|TWO_SIDED|95.0|-0.94|0.49||Non-inferiority margin of 1|Mixed Models Analysis|The models includes treatment arm, time, treatment-by-time interaction, baseline NRS, stratification variables (distance from VA \& back pain cause)|The upper limit (0.49) fell below the non-inferiority margin of 1.|3 month post-baseline time point||0.49|-0.94|<0.0001
71146865|NCT03165617|141787041|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<9 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|63.04|||||TWO_SIDED|95.0|50.66|72.32||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<9yrs||72.32|50.66|
71146866|NCT03165617|141787041|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 4 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|61.58|||||TWO_SIDED|95.0|50.25|70.53||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 4 to \<18yrs||70.53|50.25|
70874236|NCT01025752|141233414|NON_INFERIORITY|A 20% (1.4) reduction in NRS for pain intensity from baseline was considered minimally clinically important the non-inferiority margin was set at one NRS unit. The required sample size was 230 participants. Because enrollment was slower than expected and the standard deviation in the primary outcome was less than the initial power calculation (1.6 vs. 2.45) we conducted a sample size recalculation, based on observed data to determine that we would need 42 completers per arm for 80% power.|Mean Difference (Final Values)|-0.08||||0.004|TWO_SIDED|95.0|-0.86|0.71||The non-inferiority margin is 1.|Mixed Models Analysis|The models includes treatment arm, time, treatment-by-time interaction, baseline NRS, stratification variables (distance from VA \& back pain cause)|The upper limit (0.71) fell below the non-inferiority margin of 1.|6 month post- baseline time point.||0.71|-0.86|0.004
70874237|NCT01025752|141233415|OTHER||Mean Difference (Final Values)|-0.33||||0.12|TWO_SIDED|95.0|-0.74|0.09|||Mixed Models Analysis|||Post-treatment (12 weeks) time point. (Mean difference of IVR CBT- F2F CBT)||0.09|-0.74|0.12
70874238|NCT01025752|141233415|OTHER||Mean Difference (Final Values)|-0.34||||0.2|TWO_SIDED|95.0|-0.87|0.18|||Mixed Models Analysis|||3 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||0.18|-0.87|0.20
70874239|NCT01025752|141233415|OTHER||Mean Difference (Final Values)|-0.02||||0.93|TWO_SIDED|95.0|-0.57|0.52|||Mixed Models Analysis|||6 months post baseline time point. (Mean difference of IVR CBT- F2F CBT)||0.52|-0.57|0.93
70874240|NCT01025752|141233416|OTHER||Mean Difference (Final Values)|-0.5||||0.58|TWO_SIDED|95.0|-2.29|1.29|||Mixed Models Analysis|||post-treatment (12 weeks) time point||1.29|-2.29|0.58
70874241|NCT01025752|141233416|OTHER||Mean Difference (Final Values)|-1.53||||0.12|TWO_SIDED|95.0|-3.46|0.41|||Mixed Models Analysis|||3 months post-baseline time point||0.41|-3.46|0.12
70874242|NCT01025752|141233416|OTHER||Mean Difference (Final Values)|-0.61||||0.51|TWO_SIDED|95.0|-2.42|1.2|||Mixed Models Analysis|||6 months post-baseline time point||1.20|-2.42|0.51
70874243|NCT01025752|141233417|OTHER||Mean Difference (Final Values)|0.29||||0.83|TWO_SIDED|95.0|-2.3|2.87|||Mixed Models Analysis|||post-treatment (12 weeks) time point. (Mean difference of IVR CBT- F2F CBT)||2.87|-2.30|0.83
70874244|NCT01025752|141233417|OTHER||Mean Difference (Final Values)|1.15||||0.42|TWO_SIDED|95.0|-1.68|3.98|||Mixed Models Analysis|||3 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||3.98|-1.68|0.42
71146867|NCT03165617|141787041|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 9 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|64.78|||||TWO_SIDED|95.0|44.84|77.51||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 9 to \<18yrs||77.51|44.84|
70874245|NCT01025752|141233417|OTHER||Mean Difference (Final Values)|-0.58||||0.68|TWO_SIDED|95.0|-3.4|2.24|||Mixed Models Analysis|||6 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||2.24|-3.40|0.68
70874246|NCT01025752|141233418|OTHER||Mean Difference (Final Values)|1.25||||0.4|TWO_SIDED|95.0|-1.66|4.16|||Mixed Models Analysis|||post-treatment (12 weeks) time point. (Mean difference of IVR CBT- F2F CBT)||4.16|-1.66|0.40
70874247|NCT01025752|141233418|OTHER||Mean Difference (Final Values)|0.38||||0.81|TWO_SIDED|95.0|-2.82|3.58|||Mixed Models Analysis|||3 months post-baseline. (Mean difference of IVR CBT- F2F CBT)||3.58|-2.82|0.81
70874248|NCT01025752|141233418|OTHER||Mean Difference (Final Values)|2.43||||0.16|TWO_SIDED|95.0|-0.96|5.82|||Mixed Models Analysis|||6 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||5.82|-0.96|0.16
70874249|NCT01025752|141233419|OTHER||Mean Difference (Final Values)|0.24||||0.85|TWO_SIDED|95.0|-2.32|2.8|||Mixed Models Analysis|||post-treatment (12 weeks time point). (Mean difference of IVR CBT- F2F CBT)||2.80|-2.32|0.85
70874250|NCT01025752|141233419|OTHER||Mean Difference (Final Values)|-1.27||||0.4|TWO_SIDED|95.0|-4.27|1.73|||Mixed Models Analysis|||3 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||1.73|-4.27|0.40
70874251|NCT01025752|141233419|OTHER||Mean Difference (Final Values)|-0.74||||0.68|TWO_SIDED|95.0|-4.3|2.83|||Mixed Models Analysis|||6 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||2.83|-4.30|0.68
70874252|NCT01025752|141233420|OTHER||Mean Difference (Final Values)|-0.94||||0.17|TWO_SIDED|95.0|-2.28|0.4|||Mixed Models Analysis|||post-treatment (12 weeks) time point. (Mean difference of IVR CBT- F2F CBT)||0.40|-2.28|0.17
70874253|NCT01025752|141233420|OTHER||Mean Difference (Final Values)|-0.12||||0.86|TWO_SIDED|95.0|-1.39|1.16|||Mixed Models Analysis|||3 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||1.16|-1.39|0.86
70874254|NCT01025752|141233420|OTHER||Mean Difference (Final Values)|0.37||||0.64|TWO_SIDED|95.0|-1.22|1.97|||Mixed Models Analysis|||6 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||1.97|-1.22|0.64
70874255|NCT02480439|141233449|SUPERIORITY_OR_OTHER||Point Estimate|0.966|||||TWO_SIDED|90.0|0.8747|1.0668|||||Relative Bioavailability A/B. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.|||1.0668|0.8747|
70874256|NCT02480439|141233449|SUPERIORITY_OR_OTHER||Point Estimate|0.9223|||||TWO_SIDED|90.0|0.8352|1.0185|||||Relative Bioavailability B/C. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.|||1.0185|0.8352|
70874257|NCT02480439|141233450|SUPERIORITY_OR_OTHER||Point Estimate|0.9998|||||TWO_SIDED|90.0|0.954|1.0477|||||Relative Bioavailability A/B. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.|||1.0477|0.9540|
70874258|NCT02480439|141233450|SUPERIORITY_OR_OTHER||Point Estimate|1.0149|||||TWO_SIDED|90.0|0.9685|1.0636|||||Relative Bioavailability B/C. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.|||1.0636|0.9685|
70874259|NCT02480439|141233451|SUPERIORITY_OR_OTHER||Point Estimate|0.9992|||||TWO_SIDED|90.0|0.9541|1.0464|||||Relative Bioavailability A/B. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.|||1.0464|0.9541|
70874260|NCT02480439|141233451|SUPERIORITY_OR_OTHER||Point Estimate|1.0134|||||TWO_SIDED|90.0|0.9676|1.0612|||||Relative Bioavailability B/C. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.|||1.0612|0.9676|
70874261|NCT02268084|141233455|SUPERIORITY|||||||0.007|||||||ANOVA|||Null hypothesis is that the active treatment group does not differ from the sham group in changes in the PCL-M total scores.||||.007
70874262|NCT02268084|141233456|SUPERIORITY|||||||0.326|||||||t-test, 2 sided|||||||.326
70874263|NCT03334448|141233493|SUPERIORITY||Ratio of Geometric Least Square Means|0.83|||||TWO_SIDED|90.0|0.818|0.957||||||||0.957|0.818|
70874264|NCT03334448|141233494|SUPERIORITY||Ration of Lease Square Means|0.97|||||TWO_SIDED|90.0|0.83|1.09||||||||1.09|0.83|
70874265|NCT01683383|141233495|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Adjusted Wald estimation|||||||<0.001
70874266|NCT01683383|141233496|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.04
70874267|NCT01683383|141233498|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70874268|NCT00996307|141233505|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided confidence intervals (CIs) were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|4.06|||||TWO_SIDED|95.0|2.55|6.46|||||Ratio of GMTs at Day 22|||6.46|2.55|
70874269|NCT00996307|141233505|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|2.25|||||TWO_SIDED|95.0|1.42|3.56|||||Ratio of GMTs at Day 22|||3.56|1.42|
70874270|NCT00996307|141233505|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|4.49|||||TWO_SIDED|95.0|2.8|7.19|||||Ratio of GMTs at Day 22|||7.19|2.8|
70874271|NCT00996307|141233505|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|2.49|||||TWO_SIDED|95.0|1.56|3.96|||||Ratio of GMTs at Day 22|||3.96|1.56|
70874272|NCT00996307|141233505|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|8.01|||||TWO_SIDED|95.0|5.52|12.0|||||Ratio of GMTs at Day 43|||12|5.52|
71146868|NCT00135226|141787060|OTHER||Rate Ratio|0.88||||0.01|TWO_SIDED|95.0|0.79|0.97|||Log Rank|||||0.97|0.79|0.01
70874273|NCT00996307|141233505|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|4.25|||||TWO_SIDED|95.0|2.94|6.15|||||Ratio of GMTs at Day 43|||6.15|2.94|
70874274|NCT00996307|141233505|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|7.81|||||TWO_SIDED|95.0|5.36|11.0|||||Ratio of GMTs at Day 43|||11|5.36|
70874275|NCT00996307|141233505|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratios of GMTs|4.15|||||TWO_SIDED|95.0|2.86|6.02|||||Ratio of GMTs at Day 43|||6.02|2.86|
70874276|NCT00996307|141233505|SUPERIORITY_OR_OTHER||Ratio of GMTs|3.66|||||TWO_SIDED|95.0|2.37|5.65||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 22||5.65|2.37|
70874277|NCT00996307|141233505|SUPERIORITY_OR_OTHER||Ratio of GMTs|2.21|||||TWO_SIDED|95.0|1.43|3.4||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 22.||3.4|1.43|
70874278|NCT00996307|141233505|SUPERIORITY_OR_OTHER||Ratio of GMTs|4.42|||||TWO_SIDED|95.0|2.85|6.86||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 22.||6.86|2.85|
70874279|NCT00996307|141233505|SUPERIORITY_OR_OTHER||Ratio of GMTs|2.67|||||TWO_SIDED|95.0|1.72|4.13||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 22.||4.13|1.72|
70874280|NCT00996307|141233505|SUPERIORITY_OR_OTHER||Ratio of GMTs|7.82|||||TWO_SIDED|95.0|5.54|11.0||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 43.||11|5.54|
70874281|NCT00996307|141233505|SUPERIORITY_OR_OTHER||Ratio of GMTs|4.55|||||TWO_SIDED|95.0|3.23|6.42||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines||6.42|3.23|
70874282|NCT00996307|141233505|SUPERIORITY_OR_OTHER||Ratio of GMTs|7.52|||||TWO_SIDED|95.0|5.3|11.0||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 43.||11|5.3|
70874283|NCT00996307|141233505|SUPERIORITY_OR_OTHER||Ratio of GMTs|4.37|||||TWO_SIDED|95.0|3.09|6.19||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 43.||6.19|3.09|
70874284|NCT02850965|141233517|EQUIVALENCE|Protocol defined margins are: \[-18.0%, +18.0%\] for Week 16, 95% confidence interval. Between-imputation variance is zero. Confidence interval is based on one imputed set.|Difference in PASI 75 Response Rate|-2.2|||||TWO_SIDED|95.0|-14.4|8.7|||Regression, Logistic||Difference in PASI 75 Response Rate = (BI 695501 - US-licensed Humira, %).|The week 16 confidence interval for the estimated difference in percentage are produced using the cumulative distribution function method of Reeve.|The statistical model: Logit (response to treatment at Week 16)=Treatment+Baseline PASI+Prior exposure to a biologic agent+random error. Model included fixed, categorical effects of treatment (BI 695501 vs US-licensed Humira) and prior exposure to a biologic agent (yes/no), continuous effect of baseline PASI. The random error was assumed to be binomially distributed.|8.7|-14.4|
70874285|NCT02850965|141233518|OTHER|Missing PASI 75 at Week 24 data were imputed using a combination of non-responder imputation (NRI) and last observed carried forward (LOCF).|Difference in PASI 75 Response Rate|2.9|||||TWO_SIDED|95.0|-8.5|12.6|||Regression, Logistic||Difference in PASI 75 Response Rate = (BI 695501 - US-licensed Humira, %).|The week 24 confidence interval for the estimated difference in percentage are produced using the cumulative distribution function method of Reeve.|The statistical model: Logit (response to treatment at Week 24)=Treatment+Baseline PASI+Prior exposure to a biologic agent+random error. Model included fixed, categorical effects of treatment (BI 695501 vs US-licensed Humira) and prior exposure to a biologic agent (yes/no), continuous effect of baseline PASI. The random error was assumed to be binomially distributed.|12.6|-8.5|
70874286|NCT02850965|141233519|OTHER||Difference of Least Squares Means|1.7|||||TWO_SIDED|95.0|-2.7|6.0|||ANCOVA|Analysis of covariance (ANCOVA)|Difference of Least Squares Means (LSM)= LSM of (BI 695501 - Humira)|Analysis of covariance (ANCOVA) was performed based on the following model: PASI percentage improvement from baseline at Week 16= Treatment + Baseline PASI +Prior exposure to a biologic agent + random error.||6.0|-2.7|
70874287|NCT02850965|141233520|OTHER|Missing sPGA at Week 16 data were imputed using a combination of non-responder imputation (NRI) and last observed carried forward (LOCF).|Difference in sPGA <= 1 Response Rate|7.5|||||TWO_SIDED|95.0|-4.8|19.1|||Regression, Logistic||Difference in sPGA \<= 1 Response Rate = (BI 695501 - US-licensed Humira, %)|The week 16 confidence interval for the estimated difference in percentage are produced using the cumulative distribution function method of Reeve.|The statistical model: Logit (response to treatment at Week 16)=Treatment+Baseline PASI+Prior exposure to a biologic agent+random error. Model included fixed, categorical effects of treatment (BI 695501 vs US-licensed Humira) and prior exposure to a biologic agent (yes/no), continuous effect of baseline PASI.|19.1|-4.8|
70874288|NCT02850965|141233521|OTHER|Missing DLQI at Week 16 data were imputed using a combination of non-responder imputation (NRI) and last observed carried forward (LOCF).|Difference in DLQI Response Rate|0.4|||||TWO_SIDED|95.0|-11.7|11.3|||Regression, Logistic||Difference in DLQI (0, 1) Response Rate = (BI 695501 - US-licensed Humira, %)|The week 16 confidence interval for the estimated difference in percentage are produced using the cumulative distribution function method of Reeve.|The statistical model: Logit (response to treatment at Week 16)=Treatment+Baseline PASI+Prior exposure to a biologic agent+random error. Model included fixed, categorical effects of treatment (BI 695501 vs US-licensed Humira) and prior exposure to a biologic agent (yes/no), continuous effect of baseline PASI.|11.3|-11.7|
70874289|NCT01767155|141233523|OTHER||Kaplan-Meier|69.8|||||TWO_SIDED|95.0|63.6|75.1||||||Kaplan-Meier log-log transformed estimates: survivors at 6 months||75.1|63.6|
70874290|NCT01767155|141233523|OTHER||Kaplan-Meier|45.8|||||TWO_SIDED|95.0|39.5|52.0||||||Kaplan-Meier log-log transformed estimates: survivors at 12 months||52.0|39.5|
70874291|NCT01767155|141233523|OTHER||Kaplan-Meier|72.1|||||TWO_SIDED|95.0|66.0|77.3||||||Kaplan-Meier log-log transformed estimates: survivors at 6 months||77.3|66.0|
70874292|NCT01767155|141233523|OTHER||Kaplan-Meier|44.6|||||TWO_SIDED|95.0|38.2|50.7||||||Kaplan-Meier log-log transformed estimates: survivors at 12 months||50.7|38.2|
70874293|NCT01767155|141233523|OTHER||Hazard Ratio (HR)|1.06||||0.5441|TWO_SIDED|95.0|0.87|1.3|||Log Rank|2-sided||A Cox model with treatment effects was used to estimate the hazard ratio and perform hypothesis testing. The estimated hazard ratio and the 95% CI of the hazard ratio were presented.||1.30|0.87|0.5441
70874294|NCT01767155|141233524|OTHER||Odds Ratio (OR)|0.87||||0.5907|TWO_SIDED|95.0|0.52|1.45|||Mantel Haenszel|2-sided test||Hypothesis testing between the two treatment arms was performed using a Mantel Haenszel test. The odds ratio and 95% CI of the odds ratio were presented.||1.45|0.52|0.5907
70874295|NCT01767155|141233525|OTHER||Kaplan-Meier|46.7|||||TWO_SIDED|95.0|39.5|53.6||||||Kaplan-Meier log-log transformed estimates: survivors at 6 months.||53.6|39.5|
70874296|NCT01767155|141233525|OTHER||Kaplan-Meier|20.6|||||TWO_SIDED|95.0|14.6|27.4||||||Kaplan-Meier log-log transformed estimates: survivors at 12 months||27.4|14.6|
70874297|NCT01767155|141233525|OTHER||Kaplan-Meier|47.5|||||TWO_SIDED|95.0|40.0|54.7||||||Kaplan-Meier log-log transformed estimates: survivors at 6 months||54.7|40.0|
70874298|NCT01767155|141233525|OTHER||Kaplan-Meier|12.3|||||TWO_SIDED|95.0|6.9|19.3||||||Kaplan-Meier log-log transformed estimates: survivors at 12 months||19.3|6.9|
70874299|NCT01767155|141233525|OTHER||Hazard Ratio (HR)|0.89||||0.3089|TWO_SIDED|95.0|0.71|1.11|||Log Rank|2-sided||Hypothesis testing between the two treatment arms was performed using a log rank test.||1.11|0.71|0.3089
70874300|NCT01767155|141233526|OTHER||Odds Ratio (OR)|1.07||||0.6924|TWO_SIDED|95.0|0.76|1.52|||Mantel Haenszel|2-sided||Hypothesis testing between the two treatment arms was performed using a Mantel Haenszel test.||1.52|0.76|0.6924
70874301|NCT00371137|141233531|SUPERIORITY_OR_OTHER||||||>|0.001||95.0|||||Chi-squared|||Overall Comparison||||>0.001
70874302|NCT00371137|141233531|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||Pairwise comparison of placebo and Xyrem 4.5g||||<0.001
70874303|NCT00371137|141233531|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||Chi-squared|||Pairwise comparison of placebo and Xyrem 6.0g||||0.015
70874304|NCT00536198|141233532|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||ANOVA|||Group comparison||||0.21
70874305|NCT00536198|141233532|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
70874306|NCT00536198|141233532|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||ANOVA|||Group by time: comparison of rates of change||||0.06
71146869|NCT00135226|141787060|OTHER||Rate Ratio|0.97||||0.55|TWO_SIDED|95.0|0.87|1.08|||Log Rank|||||1.08|0.87|0.55
71146870|NCT00135226|141787061|OTHER||Rate Ratio|1.29||||0.003|TWO_SIDED|95.0|1.09|1.52|||Log Rank|||||1.52|1.09|0.003
71146871|NCT00135226|141787062|OTHER||Rate Ratio|0.88|||||TWO_SIDED|95.0|0.8|0.97||||||||0.97|0.80|
71146872|NCT00135226|141787062|OTHER||Rate Ratio|1.0|||||TWO_SIDED|95.0|0.91|1.09||||||||1.09|0.91|
71146873|NCT00135226|141787063|OTHER||Rate Ratio|0.99|||||TWO_SIDED|95.0|0.8|1.24||||||||1.24|0.80|
71146874|NCT00135226|141787064|OTHER||Rate Ratio|0.94|||||TWO_SIDED|95.0|0.85|1.04||||||||1.04|0.85|
71146875|NCT00135226|141787064|OTHER||Risk Ratio|0.95|||||TWO_SIDED|95.0|0.86|1.05||||||||1.05|0.86|
71146876|NCT00135226|141787065|OTHER||Rate Ratio|0.86|||||TWO_SIDED|95.0|0.66|1.12||||||||1.12|0.66|
71146877|NCT00135226|141787065|OTHER||Rate ratio|0.79|||||TWO_SIDED|95.0|0.61|1.02||||||||1.02|0.61|
71146878|NCT00135226|141787066|OTHER||Rate Ratio|1.12|||||TWO_SIDED|95.0|0.7|1.77||||||||1.77|0.7|
71146879|NCT00135226|141787066|OTHER||Rate Ratio|0.94|||||TWO_SIDED|95.0|0.59|1.5||||||||1.50|0.59|
71146880|NCT00135226|141787067|OTHER||Rate Ratio|0.96|||||TWO_SIDED|95.0|0.68|1.34||||||||1.34|0.68|
71146881|NCT00135226|141787067|OTHER||Rate Ratio|0.8|||||TWO_SIDED|95.0|0.57|1.12||||||||1.12|0.57|
71146882|NCT00135226|141787068|OTHER||Rate Ratio|0.98|||||TWO_SIDED|95.0|0.84|1.15||||||||1.15|0.84|
71146883|NCT00135226|141787068|OTHER||Rate ratio|0.95|||||TWO_SIDED|95.0|0.82|1.12||||||||1.12|0.82|
71146884|NCT00135226|141787069|OTHER||Rate ratio|1.19|||||TWO_SIDED|95.0|0.86|1.63||||||||1.63|0.86|
71146885|NCT00135226|141787069|OTHER||Rate Ratio|0.93|||||TWO_SIDED|95.0|0.68|1.28||||||||1.28|0.68|
71146886|NCT00135226|141787070|OTHER||Rate Ratio|0.8|||||TWO_SIDED|95.0|0.64|1.01||||||||1.01|0.64|
71146887|NCT00135226|141787070|OTHER||Rate Ratio|1.26|||||TWO_SIDED|95.0|1.0|1.59||||||||1.59|1.00|
71146888|NCT00135226|141787071|OTHER||Rate Ratio|0.86|||||TWO_SIDED|95.0|0.46|1.6||||||||1.60|0.46|
71146889|NCT00135226|141787071|OTHER||Rate ratio|0.77|||||TWO_SIDED|95.0|0.41|1.45||||||||1.45|0.41|
71146890|NCT00135226|141787072|OTHER||Rate Ratio|0.75|||||TWO_SIDED|95.0|0.17|3.3||||||||3.30|0.17|
71146891|NCT00135226|141787072|OTHER||Rate Ratio|0.75|||||TWO_SIDED|95.0|0.17|3.31||||||||3.31|0.17|
71146892|NCT00135226|141787073|OTHER||Rate Ratio|1.01|||||TWO_SIDED|95.0|0.92|1.11||||||||1.11|0.92|
71146893|NCT00135226|141787073|OTHER||Risk Ratio|1.0|||||TWO_SIDED|95.0|0.91|1.1||||||||1.10|0.91|
71146894|NCT00135226|141787074|OTHER||Rate Ratio|1.06|||||TWO_SIDED|95.0|0.78|1.43||||||||1.43|0.78|
71146895|NCT00135226|141787075|OTHER||Rate ratio|0.98|||||TWO_SIDED|95.0|0.74|1.29||||||||1.29|0.74|
71146896|NCT00135226|141787075|OTHER||Rate Ratio|1.04|||||TWO_SIDED|95.0|0.79|1.37||||||||1.37|0.79|
71146897|NCT00135226|141787076|OTHER||Rate Ratio|1.13|||||TWO_SIDED|95.0|0.97|1.32||||||||1.32|0.97|
71146898|NCT00135226|141787076|OTHER||Rate Ratio|1.07|||||TWO_SIDED|95.0|0.91|1.25||||||||1.25|0.91|
71146899|NCT00135226|141787077|OTHER||Rate Ratio|1.02|||||TWO_SIDED|95.0|0.76|1.38||||||||1.38|0.76|
71146900|NCT00135226|141787077|OTHER||Rate Ratio|1.17|||||TWO_SIDED|95.0|0.87|1.58||||||||1.58|0.87|
71146901|NCT00135226|141787078|OTHER||Rate Ratio|1.01|||||TWO_SIDED|95.0|0.76|1.34||||||||1.34|0.76|
71146902|NCT00135226|141787078|OTHER||Rate Ratio|1.14|||||TWO_SIDED|95.0|0.86|1.52||||||||1.52|0.86|
71146903|NCT00135226|141787079|OTHER||Rate Ratio|0.85|||||TWO_SIDED|95.0|0.58|1.23||||||||1.23|0.58|
71146904|NCT00135226|141787079|OTHER||Rate ratio|1.02|||||TWO_SIDED|95.0|0.7|1.48||||||||1.48|0.70|
71146905|NCT00135226|141787080|OTHER||Rate Ratio|0.83|||||TWO_SIDED|95.0|0.49|1.41||||||||1.41|0.49|
71146906|NCT00135226|141787080|OTHER||Rate Ratio|0.72|||||TWO_SIDED|95.0|0.42|1.22||||||||1.22|0.42|
71146907|NCT00135226|141787081|OTHER||Rate Ratio|0.84|||||TWO_SIDED|95.0|0.5|1.41||||||||1.41|0.50|
71146908|NCT00135226|141787081|OTHER||Rate Ratio|0.78|||||TWO_SIDED|95.0|0.46|1.31||||||||1.31|0.46|
71146909|NCT00135226|141787082|OTHER||Rate Ratio|1.23|||||TWO_SIDED|95.0|0.98|1.54||||||||1.54|0.98|
71146910|NCT00135226|141787083|OTHER||Rate Ratio|0.84|||||TWO_SIDED|95.0|0.63|1.12||||||||1.12|0.63|
71146911|NCT03279081|141787117|SUPERIORITY||Difference in Combined Remission Rate|2.37|||=|0.571|TWO_SIDED|95.0|-5.82|10.55||P-value was based on stratified Cochran-Mantel-Haenszel (CMH) test adjusting for interactive web response system (IWRS) randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals (CI) are displayed.|||10.55|-5.82|=0.571
71146912|NCT03279081|141787118|SUPERIORITY||Difference in Clinical Remission Rate|2.72|||=|0.515|TWO_SIDED|95.0|-5.47|10.9||P-value was based on stratified CMH test adjusting for IWRS randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals are displayed.|||10.90|-5.47|=0.515
71146913|NCT03279081|141787119|SUPERIORITY||Hazard Ratio (HR)|1.09|||=|0.374|TWO_SIDED|95.0|0.9|1.32||P-value was based on a stratified log-rank test adjusting for IWRS randomization stratification factors.|Log Rank||Cox Proportional Hazard Regression model was used to estimate the hazard ratio and 95% CI, adjusting for IWRS randomization stratification factors.|||1.32|0.90|=0.374
71146914|NCT03279081|141787120|SUPERIORITY||Difference in Combined Remission Rate|1.27|||=|0.757|TWO_SIDED|95.0|-6.77|9.31||P-value was based on stratified CMH test adjusting for IWRS randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals are displayed.|||9.31|-6.77|=0.757
71146915|NCT03279081|141787121|SUPERIORITY||Difference in Clinical Remission Rate|1.6|||=|0.697|TWO_SIDED|95.0|-6.46|9.66||P-value was based on stratified CMH test adjusting for IWRS randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals are displayed.|||9.66|-6.46|=0.697
71146916|NCT03279081|141787122|SUPERIORITY||Difference in Clinical Response Rate|3.23|||=|0.428|TWO_SIDED|95.0|-4.76|11.21||P-value was based on stratified CMH test adjusting for IWRS randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals are displayed.|||11.21|-4.76|=0.428
71146917|NCT03279081|141787123|SUPERIORITY||Difference in Clinical Response Rate|2.84|||=|0.497|TWO_SIDED|95.0|-5.35|11.03||P-value was based on stratified CMH test adjusting for IWRS randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals are displayed.|||11.03|-5.35|=0.497
71146918|NCT03279081|141787124|SUPERIORITY||Hazard Ratio (HR)|1.09|||=|0.363|TWO_SIDED|95.0|0.9|1.32||P-value was based on a stratified log-rank test adjusting for IWRS randomization stratification factors.|Log Rank||Cox Proportional Hazard Regression model was used to estimate hazard ratio and 95% CI, adjusting for IWRS randomization stratification factors.|||1.32|0.90|=0.363
70874307|NCT00536198|141233532|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.88|STANDARD_ERROR_OF_MEAN|0.95||0.049|TWO_SIDED|95.0|0.01|3.75|||Mixed Models Analysis|||Estimated mean difference from baseline to endpoint between active vs. placebo||3.75|0.01|0.049
70874308|NCT00536198|141233533|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||ANOVA|||Group comparison||||0.54
70874309|NCT00536198|141233533|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
70874310|NCT00536198|141233533|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||ANOVA|||Group by time: comparison of rates of change||||0.02
70874311|NCT00536198|141233533|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.14|STANDARD_ERROR_OF_MEAN|1.62||0.0015|TWO_SIDED|95.0|1.97|8.31|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||8.31|1.97|0.0015
70874312|NCT00536198|141233534|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||ANOVA|||Group comparison||||0.46
70955403|NCT00581555|141414467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|1.0||0.008|TWO_SIDED|95.0|0.7|4.5||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 16.||4.5|0.7|0.008
70955404|NCT00581555|141414467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|1.0||0.005|TWO_SIDED|95.0|0.9|5.0||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 20.||5.0|0.9|0.005
70955405|NCT00581555|141414467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|1.1||0.031|TWO_SIDED|95.0|0.2|4.6||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 24.||4.6|0.2|0.031
71146919|NCT03279081|141787125|SUPERIORITY||Hazard Ratio (HR)|0.98|||=|0.833|TWO_SIDED|95.0|0.82|1.18||P-value was based on a stratified log-rank test adjusting for IWRS randomization stratification factors.|Log Rank||Cox Proportional Hazard Regression model was used to estimate hazard ratio and 95% CI, adjusting for IWRS randomization stratification factors.|||1.18|0.82|=0.833
71146920|NCT03279081|141787126|SUPERIORITY||Hazard Ratio (HR)|0.97|||=|0.717|TWO_SIDED|95.0|0.81|1.16||P-value was based on a stratified log-rank test adjusting for IWRS randomization stratification factors.|Log Rank||Cox Proportional Hazard Regression model was used to estimate hazard ratio and 95% CI, adjusting for IWRS randomization stratification factors.|||1.16|0.81|=0.717
71146921|NCT03279081|141787127|SUPERIORITY||Difference in Relapse Rate|3.03|||=|0.599|TWO_SIDED|95.0|-8.28|14.34||P-value was based on stratified CMH test adjusting for IWRS randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals are displayed.|||14.34|-8.28|=0.599
70874313|NCT00536198|141233534|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.0001
70874314|NCT00536198|141233534|SUPERIORITY_OR_OTHER|||||||0.69|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||0.69
70874315|NCT00536198|141233534|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.02||||0.84|TWO_SIDED|95.0|0.83|1.26|||Mixed Models Analysis|||Estimated mean difference from Cycle 1 to end point between active vs. placebo||1.26|0.83|0.84
70874316|NCT00536198|141233535|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Chi-squared|||Group comparison||||0.01
70874317|NCT00536198|141233535|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Change over time in both groups||||<0.001
70874318|NCT00536198|141233535|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Chi-squared|||Group by time: comparison rates of change||||0.28
70874319|NCT00536198|141233535|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.59||||0.056|TWO_SIDED|95.0|0.3|1.19|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||1.19|0.30|0.056
70874320|NCT00536198|141233537|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||ANOVA|||Group comparison||||0.30
70874321|NCT00536198|141233537|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.01
70874322|NCT00536198|141233537|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||0.73
70874323|NCT00536198|141233537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.12||||0.06|TWO_SIDED|95.0|0.92|1.35|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||1.35|0.92|0.06
70874324|NCT00536198|141233538|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||ANOVA|||Group comparison||||0.80
70874325|NCT00536198|141233538|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
70874326|NCT00536198|141233538|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||0.43
70874327|NCT00536198|141233538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.11||||0.61|TWO_SIDED|95.0|0.85|1.45|||Mixed Models Analysis|||Estimated mean difference from baseline to endpoint between active vs. placebo||1.45|0.85|0.61
70874328|NCT00536198|141233539|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||ANOVA|||Group comparison||||0.83
70874329|NCT00536198|141233539|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
70874330|NCT00536198|141233539|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||0.02
70874331|NCT00536198|141233539|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.09||||0.169|TWO_SIDED|95.0|0.96|1.25|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||1.25|0.96|0.169
70874332|NCT00536198|141233540|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||ANOVA|||Group comparison||||0.37
71146922|NCT01710345|141787145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.47|STANDARD_ERROR_OF_MEAN|4.45||0.742|ONE_SIDED|95.0|||||ANCOVA|||||||0.742
70874333|NCT00536198|141233540|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
70874334|NCT00536198|141233540|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||0.73
70874335|NCT00536198|141233540|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.08||||0.13|TWO_SIDED|95.0|0.91|1.28|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||1.28|0.91|0.13
70874336|NCT00536198|141233541|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||ANOVA|||Group comparison||||0.31
70874337|NCT00536198|141233541|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
70874338|NCT00536198|141233541|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||0.46
70955406|NCT00581555|141414468|SUPERIORITY_OR_OTHER|||||||0.1196||95.0||||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|Pearson chi-square or Fisher exact test|Treatment groups and visits were fixed factors with a logit link, a binomial distribution and an auto-regressive correlation structure.||Analysis from baseline to Week 24.||||0.1196
70874339|NCT00536198|141233541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.09||||0.94|TWO_SIDED|95.0|0.96|1.23|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||1.23|0.96|0.94
70874340|NCT00536198|141233542|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Group comparison||||<0.001
70874341|NCT00536198|141233542|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
70874342|NCT00536198|141233542|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||<0.01
70874343|NCT00536198|141233542|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.22||||0.027|TWO_SIDED|95.0|1.05|1.41|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||1.41|1.05|0.027
70874344|NCT00536198|141233543|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Chi-squared|||Group comparison||||0.01
70955407|NCT03828747|141414469|SUPERIORITY||Least Squares Mean Difference|-2.89|STANDARD_ERROR_OF_MEAN|0.849||0.0008|TWO_SIDED|95.0|-4.56|-1.21|||Mixed Models Analysis|||Change from Baseline at Week 49||-1.21|-4.56|0.0008
70955408|NCT03828747|141414469|SUPERIORITY||Least Squares Mean Difference|-2.75|STANDARD_ERROR_OF_MEAN|1.287||0.0351|TWO_SIDED|95.0|-5.31|-0.2|||Mixed Models Analysis|||Change from Baseline at Week 61||-0.20|-5.31|0.0351
71146923|NCT01710345|141787145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.66|STANDARD_ERROR_OF_MEAN|4.47||0.003|ONE_SIDED|95.0|||||ANCOVA|||||||0.003
70874345|NCT00536198|141233543|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Group by time: comparison rates of change||||<0.001
70874346|NCT00536198|141233543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55||||0.056|TWO_SIDED|95.0|0.3|1.02|||Mixed Models Analysis|||Estimated mean difference between active and placebo groups at end-point only||1.02|0.30|0.056
70874347|NCT00646776|141233591|SUPERIORITY_OR_OTHER||Point Estimate|1.477|||||TWO_SIDED|90.0|1.188|1.835|||ANOVA||Point estimates and 90% confidence intervals of treatment differences on the log scale were exponentiated to obtain estimates on the original scale.|||1.835|1.188|
70874348|NCT00646776|141233592|SUPERIORITY_OR_OTHER||Point Estimate|2.489|||||TWO_SIDED|90.0|2.025|3.06|||ANOVA||Point estimates and 90% confidence intervals of treatment differences on the log scale were exponentiated to obtain estimates on the original scale.|||3.060|2.025|
70874349|NCT00646776|141233593|SUPERIORITY_OR_OTHER||Point Estimate|1.402|||||TWO_SIDED|90.0|1.052|1.867|||ANOVA||Point estimates and 90% confidence intervals of treatment differences on the log scale were exponentiated to obtain estimates on the original scale.|||1.867|1.052|
70874350|NCT00646776|141233594|SUPERIORITY_OR_OTHER||Point Estimate|0.947|||||TWO_SIDED|90.0|0.817|1.098|||ANOVA|||||1.098|0.817|
70874351|NCT00646776|141233595|SUPERIORITY_OR_OTHER||Point Estimate|0.745||||0.0963|TWO_SIDED|90.0|0.5569|0.9967|||ANOVA|||||0.9967|0.5569|0.0963
70874352|NCT00646776|141233596|SUPERIORITY_OR_OTHER||Point Estimate|0.857|||||TWO_SIDED|90.0|0.723|1.015|||ANOVA|||||1.015|0.723|
70874353|NCT00646776|141233599|SUPERIORITY_OR_OTHER||Point Estimate|0.66|||||TWO_SIDED|90.0|0.538|0.809|||ANOVA|||||0.809|0.538|
70874354|NCT00646776|141233600|SUPERIORITY_OR_OTHER||Point Estimate|0.651|||||TWO_SIDED|90.0|0.43|0.986|||ANOVA|||||0.986|0.430|
70874355|NCT00646776|141233601|SUPERIORITY_OR_OTHER||Point Estimate|0.696|||||TWO_SIDED|90.0|0.563|0.862|||ANOVA|||||0.862|0.563|
70874356|NCT00646776|141233607|SUPERIORITY_OR_OTHER||Point Estimate|10.902|||||TWO_SIDED|90.0|8.135|14.61|||ANOVA|||||14.610|8.135|
70874357|NCT00646776|141233608|SUPERIORITY_OR_OTHER||Point Estimate|7.766|||||TWO_SIDED|90.0|6.133|9.833|||ANCOVA|||||9.833|6.133|
70874358|NCT00646776|141233609|SUPERIORITY_OR_OTHER||Point Estimate|11.451|||||TWO_SIDED|90.0|8.147|16.095|||ANOVA|||||16.095|8.147|
70874359|NCT00646776|141233610|SUPERIORITY_OR_OTHER||Point Estimate|2.19|||||TWO_SIDED|90.0|1.783|2.691|||ANOVA||Point estimates and 90% confidence intervals of treatment differences on the log scale were exponentiated to obtain estimates on the original scale.|||2.691|1.783|
70874360|NCT01753856|141233625|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|Analysis of covariance (ANCOVA) model with treatment group as the main effect and baseline MS/BS as a covariate.||||||<0.001
70874361|NCT01753856|141233626|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and SL, in CC.|Fisher Exact|||||||<0.001
70874362|NCT01753856|141233626|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||SL Only, in CC.|Fisher Exact|||||||0.002
70874363|NCT01753856|141233626|SUPERIORITY_OR_OTHER|||||||0.494|TWO_SIDED|||||No Label, in CC.|Fisher Exact|||||||0.494
70874364|NCT01753856|141233626|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||DL and SL, in EC.|Fisher Exact|||||||0.001
70874365|NCT01753856|141233626|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED|||||SL Only, in EC.|Fisher Exact|||||||0.027
70874366|NCT01753856|141233626|SUPERIORITY_OR_OTHER|||||||0.118|TWO_SIDED|||||No Label, in EC.|Fisher Exact|||||||0.118
70874367|NCT01753856|141233626|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and SL, in IC.|Fisher Exact|||||||<0.001
70874368|NCT01753856|141233626|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||SL Only, in IC.|Fisher Exact|||||||0.001
70874369|NCT01753856|141233626|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED|||||No Label, in IC.|Fisher Exact|||||||>0.999
70874370|NCT01753856|141233626|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||DL and SL, in PC.|Fisher Exact|||||||0.002
70874371|NCT01753856|141233626|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||SL Only, in PC.|Fisher Exact|||||||<0.001
70874372|NCT01753856|141233626|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||No Label, in PC.|Fisher Exact|||||||<0.001
70874373|NCT01753856|141233627|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||<0.001
70874374|NCT01753856|141233627|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||<0.001
70874375|NCT01753856|141233627|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||<0.001
70874376|NCT01753856|141233628|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
70874377|NCT01753856|141233628|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||EC.|Wilcoxon (Mann-Whitney)|||||||<0.001
70874378|NCT01753856|141233628|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
70874379|NCT01753856|141233628|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||PC.|Wilcoxon (Mann-Whitney)|||||||<0.001
70874380|NCT01753856|141233629|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED|||||Remodeling-Based Bone Formation in the CC.|Wilcoxon (Mann-Whitney)|||||||0.740
70874381|NCT01753856|141233629|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED|||||Modeling-Based Bone Formation in the CC.|Wilcoxon (Mann-Whitney)|||||||0.740
70874382|NCT01753856|141233629|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||Remodeling-Based Bone Formation in the EC.|Wilcoxon (Mann-Whitney)|||||||0.008
70874383|NCT01753856|141233629|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||Modeling-Based Bone Formation in the EC.|Wilcoxon (Mann-Whitney)|||||||0.008
70874384|NCT01753856|141233629|SUPERIORITY_OR_OTHER|||||||0.661|TWO_SIDED|||||Remodeling-Based Bone Formation in the PC.|Wilcoxon (Mann-Whitney)|||||||0.661
70874385|NCT01753856|141233629|SUPERIORITY_OR_OTHER|||||||0.661|TWO_SIDED|||||Modeling-Based Bone Formation in the PC.|Wilcoxon (Mann-Whitney)|||||||0.661
70955409|NCT03828747|141414470|SUPERIORITY||Least Squares Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.295||0.5207||95.0|-3.39|1.72|||Mixed Models Analysis|||Change from Baseline at Week 49||1.72|-3.39|0.5207
70874386|NCT01753856|141233631|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
70874387|NCT01753856|141233631|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||EC.|Wilcoxon (Mann-Whitney)|||||||<0.001
70874388|NCT01753856|141233631|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED|||||PC.|Wilcoxon (Mann-Whitney)|||||||0.740
70874389|NCT01753856|141233632|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
70874390|NCT01753856|141233632|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||0.004
70874391|NCT01753856|141233632|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
70874392|NCT01753856|141233632|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED|||||PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||0.850
70874393|NCT01753856|141233633|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||DL Only, in CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||0.004
70874394|NCT01753856|141233633|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in the CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
70874395|NCT01753856|141233633|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
70874396|NCT01753856|141233633|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
70874397|NCT01753856|141233633|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
70874398|NCT01753856|141233633|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
70874399|NCT01753856|141233633|SUPERIORITY_OR_OTHER|||||||0.931|TWO_SIDED|||||DL Only, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||0.931
70874400|NCT01753856|141233633|SUPERIORITY_OR_OTHER|||||||0.549|TWO_SIDED|||||DL and Imputed SL, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||0.549
70874401|NCT01753856|141233634|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
70874402|NCT01753856|141233634|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
70874403|NCT01753856|141233634|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
70874404|NCT01753856|141233634|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
70874405|NCT01753856|141233634|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
70874406|NCT01753856|141233634|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
70874407|NCT01753856|141233634|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
70874408|NCT01753856|141233634|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
70874409|NCT01753856|141233635|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||sLS/BS, in CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
70874410|NCT01753856|141233635|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||dLS/BS, in CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
70874411|NCT01753856|141233635|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||sLS/BS, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
70955410|NCT03828747|141414470|SUPERIORITY||Least Squares Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|1.911||0.3704||95.0|-5.5|2.07|||Mixed Models Analysis|||Change from Baseline at Week 61||2.07|-5.50|0.3704
70874412|NCT01753856|141233635|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||dLS/BS, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
70874413|NCT01753856|141233635|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||sLS/BS, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
70874414|NCT01753856|141233635|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||dLS/BS, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
70874415|NCT01753856|141233635|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||sLS/BS, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
70874416|NCT01753856|141233635|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED|||||dLS/BS, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||0.028
70874417|NCT01753856|141233636|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 month.|Wilcoxon (Mann-Whitney)|||||||<0.001
70874418|NCT01753856|141233636|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||3 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
70874419|NCT01753856|141233636|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
71146924|NCT02105740|141787174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.67|STANDARD_DEVIATION|1.178||0.034|TWO_SIDED|95.0|0.224|5.11|||ANOVA|||The clinical significance was considered with a difference of 3 points on the Visual Analogue Scale (VAS) for both arms with a statistical power of 95%, significance level of 5%. Statistical analysis first compared the difference of means between hypnosis and control groups during three weeks.||5.110|0.224|0.034
70874420|NCT01753856|141233637|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 month.|Wilcoxon (Mann-Whitney)|||||||<0.001
70874421|NCT01753856|141233637|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||3 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
70874422|NCT01753856|141233637|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
70874423|NCT01753856|141233638|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 month.|Wilcoxon (Mann-Whitney)|||||||<0.001
70874424|NCT01753856|141233638|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||3 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
70874425|NCT01753856|141233638|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
70874426|NCT01753856|141233639|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 month.|Wilcoxon (Mann-Whitney)|||||||<0.001
70874427|NCT01753856|141233639|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||3 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
70874428|NCT01753856|141233639|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
70874429|NCT01753856|141233640|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
70874430|NCT01753856|141233640|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
70874431|NCT01753856|141233640|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in EC.|Wilcoxon (Mann-Whitney)|||||||<0.001
70874432|NCT01753856|141233640|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in EC.|Wilcoxon (Mann-Whitney)|||||||<0.001
70874433|NCT01753856|141233640|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
70874434|NCT01753856|141233640|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
70874435|NCT01753856|141233641|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||DL Only, in CC.|Wilcoxon (Mann-Whitney)|||||||0.002
70874436|NCT01753856|141233641|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
70874437|NCT01753856|141233641|SUPERIORITY_OR_OTHER|||||||0.214|TWO_SIDED|||||DL Only, in EC.|Wilcoxon (Mann-Whitney)|||||||0.214
70874438|NCT01753856|141233641|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||DL and Imputed SL, in EC.|Wilcoxon (Mann-Whitney)|||||||0.031
70874439|NCT01753856|141233641|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
70874440|NCT01753856|141233641|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
70874441|NCT01753856|141233642|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70874442|NCT01753856|141233643|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
70874443|NCT01753856|141233643|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||EC.|Wilcoxon (Mann-Whitney)|||||||<0.001
70874444|NCT01753856|141233643|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
70874445|NCT01753856|141233644|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
70874446|NCT01753856|141233644|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||EC.|Wilcoxon (Mann-Whitney)|||||||<0.001
70874447|NCT01753856|141233644|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
70874448|NCT01753856|141233645|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Average length of DLs in the CC|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||<0.001
70874449|NCT01753856|141233645|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||Average length of double labels in EC|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||0.004
71146925|NCT02105740|141787174|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.66|STANDARD_DEVIATION|0.856||0.004|TWO_SIDED|95.0|1.253|6.08|||ANOVA|||The clinical significance was considered with a difference of 3 points on the Visual Analogue Scale (VAS) with a statistical power of 95%, significance level of 5%. Statistical analysis compared the difference in pain average between the first and the second week in the hypnosis group.||6.080|1.253|0.004
70874450|NCT01753856|141233645|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Average length of double labels in IC|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||<0.001
70874451|NCT01753856|141233645|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED|||||Average length of double labels in the PC|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||0.850
71146926|NCT02105740|141787174|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.25|STANDARD_DEVIATION|0.827||0|TWO_SIDED|95.0|2.918|7.582|||ANOVA|||The clinical significance was considered with a difference of 3 points on the Visual Analogue Scale (VAS) with a statistical power of 95%, significance level of 5%. Statistical analysis compared the difference in pain average between the first and the third week in the hypnosis group.||7.582|2.918|0.000
71146927|NCT02105740|141787175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|||||TWO_SIDED|||||||||Statistical analysis evaluated if the difference of averages of anxiety at the hypnosis and control groups in the third week.||||
71146928|NCT02105740|141787175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|||||TWO_SIDED|||||||||Statistical analysis evaluated if the difference of averages of depression at the hypnosis and control groups in the third week.||||
71146929|NCT05810740|141787176|OTHER||LS-Mean Ratio, Percent|96.43|||||TWO_SIDED|90.0|92.57|100.46||||||||100.46|92.57|
70874452|NCT01753856|141233646|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
70874453|NCT01753856|141233646|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED|||||EC.|Wilcoxon (Mann-Whitney)|||||||0.042
70874454|NCT01753856|141233646|SUPERIORITY_OR_OTHER|||||||0.678|TWO_SIDED|||||IC.|Wilcoxon (Mann-Whitney)|||||||0.678
70874455|NCT01753856|141233647|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC|Wilcoxon (Mann-Whitney)|||||||<0.001
70874456|NCT01753856|141233647|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||EC|Wilcoxon (Mann-Whitney)|||||||<0.001
70874457|NCT01753856|141233647|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||IC|Wilcoxon (Mann-Whitney)|||||||<0.001
70874458|NCT04853225|141233728|OTHER||Adjusted rate of change|-59.46|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
70874459|NCT04853225|141233728|OTHER||Adjusted rate of change|-62.73|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
70874460|NCT04853225|141233728|OTHER||Adjusted rate of change|-48.54|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
70874461|NCT04853225|141233728|OTHER||Adjusted rate of change|-50.32|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
70874462|NCT04853225|141233728|OTHER||Adjusted rate of change|-22.67|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
70874463|NCT04853225|141233728|OTHER||Adjusted rate of change|-33.32|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
71146930|NCT05810740|141787177|OTHER||Geometric Mean Ratio|97.19|||||TWO_SIDED|90.0|93.47|101.06||||||||101.06|93.47|
71146931|NCT05810740|141787178|OTHER||Geometric Mean Ratio|94.02|||||TWO_SIDED|90.0|87.25|101.33||||||||101.33|87.25|
71146932|NCT05452486|141787208|EQUIVALENCE|The purpose of this study was to evaluate whether the mean performance on auditory processing assessments differed depending on whether the tests were administered in Spanish or English.|Slope|-3.89|||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||Dichotic digits comparison||||<0.01
71146933|NCT05452486|141787208|EQUIVALENCE|The purpose of this study was to evaluate whether the mean performance on auditory processing assessments differed depending on whether the tests were administered in Spanish or English.|Slope|5.18||||0.69|TWO_SIDED||||||Mixed Models Analysis|||Dichotic words comparison||||0.69
71146934|NCT00107653|141787209|SUPERIORITY_OR_OTHER||SVR for Study Group Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|-0.24|-0.08||P-values are calculated based on the difference in proportion between Latino and Non-Latino White group|Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with SVR. The 95% Confidence Interval is based on normal approximation to the binomial.|SVR for Latino Versus (VS) Non-Latino White||-0.08|-0.24|<0.0001
71146935|NCT00107653|141787210|SUPERIORITY_OR_OTHER||Study Group Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.031||0.0454|TWO_SIDED|95.0|-0.12|0.0|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 4||-0.00|-0.12|0.0454
71146936|NCT00107653|141787210|SUPERIORITY_OR_OTHER||Study Group Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.041||0.0003|TWO_SIDED|95.0|-0.23|-0.07|||Normal approximation to the binomial.||The estimated value is the Difference in proportion of participants (Latino minus Non-Latino White) with virologic response. the 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 12||-0.07|-0.23|0.0003
70874464|NCT04853225|141233728|OTHER||Adjusted rate of change|-20.4|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
70874465|NCT04853225|141233728|OTHER||Adjusted rate of change|-31.08|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
70874466|NCT04853225|141233728|OTHER||Adjusted rate of change|-64.74|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
70874467|NCT04853225|141233728|OTHER||Adjusted rate of change|-60.26|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
70874468|NCT04853225|141233728|OTHER||Adjusted rate of change|-27.85|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
70874469|NCT04853225|141233728|OTHER||Adjusted rate of change|-28.65|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
70874470|NCT04853225|141233729|OTHER||Adjusted rate of change|-87.47|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
70874471|NCT04853225|141233729|OTHER||Adjusted rate of change|-83.25|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
71146937|NCT00107653|141787210|SUPERIORITY_OR_OTHER||Study Group Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.039||0.0004|TWO_SIDED|95.0|-0.22|-0.06|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 24||-0.06|-0.22|0.0004
71146938|NCT00107653|141787210|SUPERIORITY_OR_OTHER||Study Group Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.24|-0.09|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 48||-0.09|-0.24|<0.0001
71146939|NCT00107653|141787210|SUPERIORITY_OR_OTHER||Study Group Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|-0.25|-0.09|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 60||-0.09|-0.25|<0.0001
70955411|NCT03828747|141414471|SUPERIORITY||Least Squares Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.282||0.3501||95.0|-0.29|0.82|||Mixed Models Analysis|||Change from Baseline at Week 49||0.82|-0.29|0.3501
70955412|NCT03828747|141414471|SUPERIORITY||Least Squares Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.525||0.7431|TWO_SIDED|95.0|-0.87|1.22|||Mixed Models Analysis|||Change from Baseline at Week 61||1.22|-0.87|0.7431
70955413|NCT03828747|141414472|SUPERIORITY||Least Squares Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.429||0.5366||95.0|-0.58|1.11|||Mixed Models Analysis|||Change from Baseline at Week 49||1.11|-0.58|0.5366
71146940|NCT00107653|141787210|SUPERIORITY_OR_OTHER||Study Group Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|-0.24|-0.08|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 72||-0.08|-0.24|<0.0001
71146941|NCT00107653|141787211|SUPERIORITY_OR_OTHER||Study Group Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.036||0.0353|TWO_SIDED|95.0|-0.15|-0.01|||Normal approximation to the binomial.||The estimated value is the Difference in proportion of participants (Latino minus Non-Latino White) with virologic response. the 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 4||-0.01|-0.15|0.0353
71146942|NCT00107653|141787212|SUPERIORITY_OR_OTHER||Study Group Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.033||0.0014|TWO_SIDED|95.0|-0.17|-0.04|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 12||-0.04|-0.17|0.0014
71146943|NCT00107653|141787214|SUPERIORITY_OR_OTHER||Study Group Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.042||0.0006|TWO_SIDED|95.0|-0.22|-0.06|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 4||-0.06|-0.22|0.0006
71146944|NCT00107653|141787214|SUPERIORITY_OR_OTHER||Study Group Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.24|-0.08|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 12||-0.08|-0.24|<0.0001
71146945|NCT00107653|141787214|SUPERIORITY_OR_OTHER||Study Group Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.041||0.0003|TWO_SIDED|95.0|-0.23|-0.07|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 24||-0.07|-0.23|0.0003
71146946|NCT00107653|141787214|SUPERIORITY_OR_OTHER||Study Group Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.042||0.0008|TWO_SIDED|95.0|-0.22|-0.06|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 48||-0.06|-0.22|0.0008
70955414|NCT03828747|141414472|SUPERIORITY||Least Squares Mean Difference|1.08|STANDARD_ERROR_OF_MEAN|0.618||0.0851||95.0|-0.15|2.3|||Mixed Models Analysis|||Change from Baseline at Week 61||2.30|-0.15|0.0851
71146947|NCT00107653|141787214|SUPERIORITY_OR_OTHER||Study Group Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|-0.26|-0.1|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 60||-0.10|-0.26|<0.0001
71146948|NCT00107653|141787214|SUPERIORITY_OR_OTHER||Study Group Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|-0.27|-0.11|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 72||-0.11|-0.27|<0.0001
71146949|NCT00107653|141787215|SUPERIORITY_OR_OTHER||Study Group Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0285|TWO_SIDED|95.0|-0.2|0.0|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with ISHAK HAI response. The 95% Confidence Interval is based on normal approximation to the binomial.|ISHAK HAI Response For Latino VS Non-Latino White||-0.0|-0.2|0.0285
71146950|NCT00107653|141787216|SUPERIORITY_OR_OTHER||Study Group Difference|0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|0.5|1.3|||Normal approximation to the binomial.||The estimated value is the difference in change from baseline of ISHAK HAI activity (necroinflammatory) scores between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|ISHAK HAI activity For Latino VS Non-Latino White||1.3|0.5|<0.0001
70955415|NCT00359216|141414568|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9219||95.0|||||ANCOVA|||The p-value is obtained by F-test in ANCOVA to assess the treatment group difference in changes from baseline, adjusted for baseline.||||0.9219
70955416|NCT02015455|141414643|SUPERIORITY||Percent Difference in Median|-0.7||||0.54|TWO_SIDED|95.0|-2.9|1.5|||Mixed Models Analysis|Adjusted for site, clinic size, age, sex, image modality, comorbidity, and site time trends. Random effects for clinic and provider.|Percent difference in median of the intervention group with respect to the control group.|||1.5|-2.9|0.54
70874472|NCT04853225|141233729|OTHER||Adjusted rate of change|-77.54|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
70874473|NCT04853225|141233729|OTHER||Adjusted rate of change|-77.41|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
70955417|NCT02015455|141414644|SUPERIORITY||Odds Ratio (OR)|0.95||||0.04|TWO_SIDED|95.0|0.91|1.0||A p-value \<0.05 was considered significant.|Mixed Models Analysis|Adjusted for site, clinic size, age, sex, image modality, comorbidity, prior opioid use, site time trends. Random effects for clinic and provider.|Odds ratio is for the intervention group with respect to the control group.|||1.00|0.91|0.04
70874474|NCT04853225|141233729|OTHER||Adjusted rate of change|-60.1|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
70874475|NCT04853225|141233729|OTHER||Adjusted rate of change|-73.65|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
70874476|NCT04853225|141233729|OTHER||Adjusted rate of change|-45.44|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
70874477|NCT04853225|141233729|OTHER||Adjusted rate of change|-79.49|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
70874478|NCT04853225|141233729|OTHER||Adjusted rate of change|-74.39|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
70874479|NCT04853225|141233729|OTHER||Adjusted rate of change|-63.04|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
70874480|NCT04853225|141233729|OTHER||Adjusted rate of change|-25.59|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
71146951|NCT00107653|141787225|SUPERIORITY_OR_OTHER||Study Group Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.162|<|0.0001|TWO_SIDED|95.0|-0.96|-0.33|||ANCOVA||The estimated value is the difference of change from baseline in FSS scores at week 48 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|FSS Score of Latino VS Non-Latino White at week 48||-0.33|-0.96|<0.0001
70874481|NCT04853225|141233729|OTHER||Adjusted rate of change|-38.69|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
70874482|NCT01804075|141233731|SUPERIORITY|||||||0.6|||||||Chi-squared|||||||0.6
70874483|NCT02785354|141233758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.51|0.66|||Fine and Gray model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for dabigatran versus VKA, with hazard ratio (HR) and 95% Confidence Interval (CI ) (and death as a competing risk).||0.66|0.51|<0.0001
70874484|NCT02785354|141233758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0006|TWO_SIDED|95.0|0.75|0.92|||Fine and Gray model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI (and death as a competing risk).||0.92|0.75|0.0006
70874485|NCT02785354|141233759|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55|||<|0.0001|TWO_SIDED|95.0|0.46|0.66|||Fine and Gray model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for dabigatran versus VKA, with hazard ratio (HR) and 95%CI (and death as a competing risk).||0.66|0.46|<0.0001
70874486|NCT02785354|141233759|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|95.0|0.58|0.79|||Fine and Gray model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI (and death as a competing risk).||0.79|0.58|<0.0001
70874487|NCT02785354|141233760|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.0007|TWO_SIDED|95.0|0.63|0.88|||Fine and Gray model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for dabigatran versus VKA, with hazard ratio (HR) and 95%CI (and death as a competing risk).||0.88|0.63|0.0007
70874488|NCT02785354|141233760|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.8341|TWO_SIDED|95.0|0.85|1.14|||Fine and Gray model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI (and death as a competing risk).||1.14|0.85|0.8341
70874489|NCT02785354|141233761|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0147|TWO_SIDED|95.0|0.65|0.95|||Fine and Gray model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for dabigatran versus VKA, with hazard ratio (HR) and 95%CI (and death as a competing risk).||0.95|0.65|0.0147
70874490|NCT02785354|141233761|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0501|TWO_SIDED|95.0|0.71|1.0|||Fine and Gray model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI (and death as a competing risk).||1.00|0.71|0.0501
70874491|NCT02785354|141233762|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||<|0.0001|TWO_SIDED|95.0|0.67|0.82|||Cox proportional hazard risk model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Kaplan-Meier to estimate the cumulative incidence, 2) Cox proportional hazard risk model to compare the 1-year risk for dabigatran versus VKA, with HR and 95%CI.||0.82|0.67|<0.0001
70874492|NCT02785354|141233762|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77|||<|0.0001|TWO_SIDED|95.0|0.71|0.84|||Cox proportional hazard risk model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Kaplan-Meier to estimate the cumulative incidence, 2) Cox proportional hazard risk model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI.||0.84|0.71|<0.0001
71146952|NCT00107653|141787225|SUPERIORITY_OR_OTHER||Study Group Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.156||0.0921|TWO_SIDED|95.0|-0.57|0.04|||ANCOVA||The estimated value is the difference of change from baseline in FSS scores at week 72 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|FSS Score of Latino VS Non-Latino White at week 72||0.04|-0.57|0.0921
70874493|NCT02785354|141233763|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.66|0.76|||Cox proportional hazard risk model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Kaplan-Meier to estimate the cumulative incidence, 2) Cox proportional hazard risk model to compare the 1-year risk for dabigatran versus VKA, with HR and 95%CI.||0.76|0.66|<0.0001
70874494|NCT02785354|141233763|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84|||<|0.0001|TWO_SIDED|95.0|0.79|0.89|||Cox proportional hazard risk model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Kaplan-Meier to estimate the cumulative incidence, 2) Cox proportional hazard risk model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI.||0.89|0.79|<0.0001
70874495|NCT02310568|141233766|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|2.01||0.784|TWO_SIDED|90.0|-2.8|3.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||3.9|-2.8|0.784
70874496|NCT02310568|141233766|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.94||0.184|TWO_SIDED|90.0|-0.6|5.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||5.8|-0.6|0.184
70874497|NCT02310568|141233766|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.22||0.36|TWO_SIDED|90.0|-5.7|1.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||1.6|-5.7|0.360
70874498|NCT02310568|141233768|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|2.36||0.708|TWO_SIDED|90.0|-3.2|5.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||5.0|-3.2|0.708
70955418|NCT02015455|141414645|SUPERIORITY||Odds Ratio (OR)|0.95||||0.02|TWO_SIDED|95.0|0.9|0.99||The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|Adjusted for site, clinic size, age, sex, image modality, comorbidity, prior opioid use, site time trends. Random effects for clinic and provider.|Odds ratio is for the intervention group with respect to the control group.|||0.99|0.90|0.02
70955419|NCT02015455|141414646|SUPERIORITY||Odds Ratio (OR)|0.95||||0.02|TWO_SIDED|95.0|0.91|0.99||The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|Adjusted for site, clinic size, age, sex, image modality, comorbidity, prior opioid use, site time trends. Random effects for clinic and provider.|Odds ratio is for the intervention group with respect to the control group.|||0.99|0.91|0.02
70955420|NCT02015455|141414650|SUPERIORITY||Odds Ratio (OR)|0.99||||0.74|TWO_SIDED|95.0|0.91|1.07||Statistical significance defined as P\<0.05|Mixed Models Analysis|Adjusted for site, clinic size, age, sex, image modality, comorbidity, site time trends. Random effects for clinic and provider.|Odds ratio is for the intervention group with respect to the control group.|||1.07|0.91|0.74
70955421|NCT00911937|141414743|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.003|TWO_SIDED|95.0|-0.37|-0.08||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Analysis of covariance (ANCOVA) model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.08|-0.37|0.0030
71146953|NCT00107653|141787225|SUPERIORITY_OR_OTHER||Study Group Difference|-8.72|STANDARD_ERROR_OF_MEAN|2.725||0.0015|TWO_SIDED|95.0|-14.07|-3.36|||ANCOVA||The estimated value is the difference of change from baseline in FSS VAS scores at week 48 between Latino and Non-Latino White participants The 95% Confidence Interval is based on normal approximation to the binomial.|FSS VAS Score of Latino VS Non-Latino White at week 48||-3.36|-14.07|0.0015
70874499|NCT02310568|141233768|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.36||0.646|TWO_SIDED|90.0|-5.2|3.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||3.0|-5.2|0.646
70874500|NCT02310568|141233768|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|2.09||0.352|TWO_SIDED|90.0|-1.6|5.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||5.6|-1.6|0.352
70874501|NCT02310568|141233768|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|2.99||0.495|TWO_SIDED|90.0|-3.1|7.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||7.3|-3.1|0.495
70955422|NCT00911937|141414744|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.0772|TWO_SIDED|95.0|-0.27|0.01||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||0.01|-0.27|0.0772
70955423|NCT00911937|141414745|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0001
70874502|NCT02310568|141233768|SUPERIORITY_OR_OTHER||LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|2.99||0.422|TWO_SIDED|90.0|-2.7|7.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||7.6|-2.7|0.422
70874503|NCT02310568|141233768|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|2.65||0.889|TWO_SIDED|90.0|-5.0|4.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||4.2|-5.0|0.889
70874504|NCT02310568|141233768|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|2.71||0.324||90.0|-2.0|7.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||7.4|-2.0|0.324
70874505|NCT02310568|141233768|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|2.69||0.939|TWO_SIDED|90.0|-4.5|4.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||4.9|-4.5|0.939
70874506|NCT02310568|141233768|SUPERIORITY_OR_OTHER||LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|2.42||0.308|TWO_SIDED|90.0|-1.7|6.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||6.7|-1.7|0.308
70874507|NCT02310568|141233768|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|3.92||0.846|TWO_SIDED|90.0|-6.0|7.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||7.6|-6.0|0.846
70955424|NCT00911937|141414747|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.0827|TWO_SIDED|95.0|-0.25|0.01||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||0.01|-0.25|0.0827
70955425|NCT00911937|141414747|SUPERIORITY_OR_OTHER||Least Squares mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.07||0.0112|TWO_SIDED|95.0|-0.33|-0.04||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.04|-0.33|0.0112
70955426|NCT00911937|141414748|SUPERIORITY_OR_OTHER|||||||0.0023|TWO_SIDED|||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0023
70955427|NCT00911937|141414750|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.15||0.0026|TWO_SIDED|95.0|-0.74|-0.16||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.16|-0.74|0.0026
70874508|NCT02310568|141233768|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|3.89||0.449|TWO_SIDED|90.0|-9.8|3.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||3.7|-9.8|0.449
70874509|NCT02310568|141233768|SUPERIORITY_OR_OTHER||LS Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|3.51||0.295|TWO_SIDED|90.0|-2.3|9.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||9.9|-2.3|0.295
70955428|NCT00911937|141414750|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.17||0.0014|TWO_SIDED|95.0|-0.9|-0.22||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.22|-0.90|0.0014
70955429|NCT00911937|141414751|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED|||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0016
70955430|NCT00911937|141414751|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED|||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0004
70955431|NCT00911937|141414753|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.22||0.0072|TWO_SIDED|95.0|-1.03|-0.16||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.16|-1.03|0.0072
70955432|NCT00911937|141414753|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.24||0.0009|TWO_SIDED|95.0|-1.25|-0.32||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.32|-1.25|0.0009
70874510|NCT02310568|141233770|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|1.72||0.514|TWO_SIDED|90.0|-4.0|1.7|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Total Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.7|-4.0|0.514
70874511|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|1.65||0.302|TWO_SIDED|90.0|-4.5|1.0|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Total Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.0|-4.5|0.302
70874512|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.94||0.736|TWO_SIDED|90.0|-2.6|3.8|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Total Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||3.8|-2.6|0.736
70874513|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|3.85||0.775|TWO_SIDED|90.0|-5.6|7.8|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Total Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||7.8|-5.6|0.775
70874514|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|4.0||0.553|TWO_SIDED|90.0|-9.4|4.5|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Total Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||4.5|-9.4|0.553
70874515|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|3.3||0.299|TWO_SIDED|90.0|-2.2|9.3|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Total Score ( Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||9.3|-2.2|0.299
70874516|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.65||0.994|TWO_SIDED|90.0|-1.1|1.1|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Social Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.1|-1.1|0.994
70955433|NCT00911937|141414754|SUPERIORITY_OR_OTHER|||||||0.0041|TWO_SIDED|||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0041
70955434|NCT00911937|141414754|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||<0.0001
70955435|NCT00911937|141414756|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.17||0.3954|TWO_SIDED|95.0|-0.47|0.19||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||0.19|-0.47|0.3954
70874517|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.62||0.87|TWO_SIDED|90.0|-0.9|1.1|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Social Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.1|-0.9|0.870
70874518|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.74||0.885|TWO_SIDED|90.0|-1.3|1.1|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Social Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.1|-1.3|0.885
70874519|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.78||0.834|TWO_SIDED|90.0|-3.5|2.7|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Social Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||2.7|-3.5|0.834
70874520|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.8||0.281|TWO_SIDED|90.0|-5.1|1.1|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Social Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.1|-5.1|0.281
70955436|NCT00911937|141414756|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.15||0.2166|TWO_SIDED|95.0|-0.48|0.11||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||0.11|-0.48|0.2166
70874521|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|1.43||0.272|TWO_SIDED|90.0|-0.9|4.1|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Social Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||4.1|-0.9|0.272
70874522|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.73||0.249|TWO_SIDED|90.0|-2.1|0.4|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Work Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.4|-2.1|0.249
70874523|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.016|TWO_SIDED|90.0|-2.9|-0.6|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Work Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||-0.6|-2.9|0.016
70874524|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.82||0.285|TWO_SIDED|0.285|-0.5|2.3|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Work Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||2.3|-0.5|0.285
70874525|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.38||0.635|TWO_SIDED|90.0|-3.1|1.8|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Work Sub-Scale Score ( Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.8|-3.1|0.635
70874526|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.43||0.217|TWO_SIDED|90.0|-4.4|0.7|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Work Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.7|-4.4|0.217
71146954|NCT00107653|141787225|SUPERIORITY_OR_OTHER||Study Group Difference|4.83|STANDARD_ERROR_OF_MEAN|2.37||0.0421|TWO_SIDED|95.0|0.18|9.49|||ANCOVA||The estimated value is the difference of change from baseline in FSS VAS scores at week 72 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|FSS VAS Score of Latino VS Non-Latino White at week 72||9.49|0.18|0.0421
71146955|NCT00107653|141787226|SUPERIORITY_OR_OTHER||Study Group Difference|3.49|STANDARD_ERROR_OF_MEAN|0.864|<|0.0001|TWO_SIDED|95.0|1.79|5.18|||ANCOVA||The estimated value is the difference of change from baseline in standardized physical component score at week 48 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|Standardized Physical Component of Latino VS Non-Latino White at week 48||5.18|1.79|<0.0001
71146956|NCT00107653|141787226|SUPERIORITY_OR_OTHER||Study Group Difference|0.1|STANDARD_ERROR_OF_MEAN|0.808||0.9047|TWO_SIDED|95.0|-1.49|1.68|||ANCOVA||The estimated value is the difference of change from baseline in standardized physical component score at week 48 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|Standardized Physical Component of Latino VS Non-Latino White at week 72||1.68|-1.49|0.9047
71146957|NCT00107653|141787226|SUPERIORITY_OR_OTHER||Study Group Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.914||0.9286|TWO_SIDED|95.0|-1.88|1.71|||ANCOVA||The estimated value is the difference of change from baseline in standardized mental component score at week 48 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|Standardized Mental Component of Latino VS Non-Latino White at week 48||1.71|-1.88|0.9286
71146958|NCT00107653|141787226|SUPERIORITY_OR_OTHER||Study Group Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.888||0.1653|TWO_SIDED|95.0|-2.98|0.51|||ANCOVA||The estimated value is the difference of change from baseline in standardized mental component score at week 72 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|Standardized Mental Component of Latino VS Non-Latino White at week 72||0.51|-2.98|0.1653
71146959|NCT04314284|141787260|SUPERIORITY|||||||0.15|||||||Kruskal-Wallis|||||||0.15
71146960|NCT04314284|141787261|SUPERIORITY|||||||0.35|||||||Kruskal-Wallis|||||||0.35
71146961|NCT04314284|141787262|SUPERIORITY|||||||0.22|||||||Chi-squared|||||||0.22
71146962|NCT04314284|141787266|SUPERIORITY|||||||0.65|||||||Kruskal-Wallis|||||||0.65
71146963|NCT04314284|141787267|SUPERIORITY|||||||0.52|||||||Kruskal-Wallis|||||||0.52
71146964|NCT04314284|141787268|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.51
71146965|NCT04314284|141787271|OTHER|2-sided||||||0.71|||||||t-test, 2 sided|||||||0.71
71146966|NCT04314284|141787272|OTHER|2-sided||||||0.12|||||||t-test, 2 sided|||||||0.12
71146967|NCT04314284|141787274|SUPERIORITY|||||||0.66|||||||Kruskal-Wallis|||||||0.66
71146968|NCT00124943|141787294|SUPERIORITY_OR_OTHER|||||||0.396||95.0|||||Fisher Exact|||The statistical testing of treatment difference is for exploratory purposes.||||0.396
71146969|NCT00124943|141787295|SUPERIORITY_OR_OTHER|||||||0.783||95.0|||||Fisher Exact|||Comparison of the number of patients with any treatment emergent adverse event. The statistical testing of treatment difference is for exploratory purposes.||||0.783
71146970|NCT00124943|141787296|SUPERIORITY_OR_OTHER|||||||0.293||95.0|||||Fisher Exact|||Comparison of in-stent binary restenosis. The statistical testing of treatment difference is for exploratory purposes.||||0.293
70874527|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.36||0.399|TWO_SIDED|90.0|-1.2|3.6|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Work Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||3.6|-1.2|0.399
71146971|NCT00124943|141787296|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Fisher Exact|||Comparison of in-segment binary restenosis. The statistical testing of treatment difference is for exploratory purposes||||0.400
70874528|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.62||0.429|TWO_SIDED|90.0|-1.5|0.5|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Family Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.5|-1.5|0.429
70874529|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.26|TWO_SIDED|90.0|-1.7|0.3|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Family Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.3|-1.7|0.260
70874530|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.7||0.799|TWO_SIDED|90.0|-1.0|1.3|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Family Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.3|-1.0|0.799
70874531|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.22||0.738|TWO_SIDED|90.0|-1.7|2.5|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Family Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||2.5|-1.7|0.738
70874532|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|1.26|STANDARD_ERROR_OF_MEAN|-0.5||0.691|TWO_SIDED|90.0|-2.7|1.7|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Family Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.7|-2.7|0.691
71146972|NCT00124943|141787297|SUPERIORITY_OR_OTHER||||||>|0.999||95.0|||||Fisher Exact|||The statistical testing of treatment difference is for exploratory purposes.||||>0.999
71146973|NCT00124943|141787298|SUPERIORITY_OR_OTHER|||||||0.061||95.0|||||Fisher Exact|||The statistical testing of treatment difference is for exploratory purposes.||||0.061
71146974|NCT00124943|141787299|SUPERIORITY_OR_OTHER|||||||0.709||95.0|||||Fisher Exact|||Comparison of in-stent late lumen loss. The statistical testing of treatment difference is for exploratory purposes.||||0.709
71146975|NCT00124943|141787299|SUPERIORITY_OR_OTHER|||||||0.495||95.0|||||Fisher Exact|||Comparison of in-segment late lumen loss. The statistical testing of treatment difference is for exploratory purposes.||||0.495
71146976|NCT00124943|141787300|SUPERIORITY_OR_OTHER|||||||0.317||95.0|||||ANOVA|P-value testing dose group differences based on an analysis of variance with dose effect in the model.||||||0.317
71146977|NCT04196777|141787301|OTHER|We performed a logistic regression analysis that measured the effect of the intervention at site 3. The below results show the interaction term between time and the intervention from this model. Time was measured in days divided by 365, giving an annualized figure for the time coefficient estimate and interaction coefficient.|Odds Ratio (OR)|0.089||||0.004|TWO_SIDED|95.0|0.016|0.445|||Regression, Logistic|||To model the primary outcome for site 3, we used a logistic regression model and a set of three explanatory variables: time, a binary indicator for an observation occurring within the intervention phase, and an interaction term between these two main effects (time and intervention).||0.445|0.016|0.004
71146978|NCT04196777|141787301|OTHER|We performed a logistic regression analysis that measured the effect of the intervention at site 1. The below results show the interaction term between time and the intervention from this model. Time was measured in days divided by 365, giving an annualized figure for the time coefficient estimate and interaction coefficient.|Odds Ratio (OR)|1.593||||0.259|TWO_SIDED|95.0|0.71|3.585|||Regression, Logistic|||To model the primary outcome for site 1, we used a logistic regression model and a set of three explanatory variables: time, a binary indicator for an observation occurring within the intervention phase, and an interaction term between these two main effects (time and intervention).||3.585|0.710|0.259
71146979|NCT04196777|141787301|OTHER|We performed a logistic regression analysis that measured the effect of the intervention at site 2. The below results show the interaction term between time and the intervention from this model. Time was measured in days divided by 365, giving an annualized figure for the time coefficient estimate and interaction coefficient.|Odds Ratio (OR)|0.748||||0.738|TWO_SIDED|95.0|0.135|4.147|||Regression, Logistic|||To model the primary outcome for site 2, we used a logistic regression model and a set of three explanatory variables: time, a binary indicator for an observation occurring within the intervention phase, and an interaction term between these two main effects (time and intervention).||4.147|0.135|0.738
71146980|NCT04196777|141787302|OTHER|The Wilcoxon rank-sum test assessed whether the post-procedural antimicrobial duration significantly differed at site 3 between the baseline and intervention periods.|Rank sum test statistic|1280.5||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The median duration of post-procedural antimicrobial prescriptions at site 3 were compared using the Wilcoxon rank-sum test.||||0.001
70955437|NCT00911937|141414759|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.24||0.1018|TWO_SIDED|95.0|-0.85|0.08||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||0.08|-0.85|0.1018
70955438|NCT00911937|141414759|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.24||0.0027|TWO_SIDED|95.0|-1.2|-0.25||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.25|-1.20|0.0027
70955439|NCT00911937|141414761|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.56|STANDARD_ERROR_OF_MEAN|0.63||0.0131|TWO_SIDED|95.0|-2.79|-0.33||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.33|-2.79|0.0131
70955440|NCT00911937|141414761|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.43|STANDARD_ERROR_OF_MEAN|0.69||0.0004|TWO_SIDED|95.0|-3.78|-1.08||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-1.08|-3.78|0.0004
70955441|NCT00911937|141414763|SUPERIORITY_OR_OTHER||Least squares mean difference|1.32|STANDARD_ERROR_OF_MEAN|7.2||0.8547|TWO_SIDED|95.0|-12.82|15.46||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||15.46|-12.82|0.8547
70955442|NCT00911937|141414765|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.85|STANDARD_ERROR_OF_MEAN|4.22||0.8396|TWO_SIDED|95.0|-9.14|7.44||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||7.44|-9.14|0.8396
70955443|NCT00911937|141414767|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.37|STANDARD_ERROR_OF_MEAN|1.26||0.0006|TWO_SIDED|95.0|-6.84|-1.89||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-1.89|-6.84|0.0006
70955444|NCT00911937|141414769|SUPERIORITY_OR_OTHER||Least squares mean difference|3.42|STANDARD_ERROR_OF_MEAN|1.34||0.011|TWO_SIDED|95.0|0.79|6.05||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: Concern domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||6.05|0.79|0.0110
70955445|NCT00911937|141414769|SUPERIORITY_OR_OTHER||Least squares mean difference|3.14|STANDARD_ERROR_OF_MEAN|1.35||0.02|TWO_SIDED|95.0|0.5|5.79||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: Coping domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||5.79|0.50|0.0200
70955446|NCT00911937|141414769|SUPERIORITY_OR_OTHER||Least squares mean difference|3.48|STANDARD_ERROR_OF_MEAN|1.51||0.0218|TWO_SIDED|95.0|0.51|6.45||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: Sleep domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||6.45|0.51|0.0218
71146981|NCT04196777|141787302|OTHER|The Wilcoxon rank-sum test assessed whether the post-procedural antimicrobial duration significantly differed at site 1 between the baseline and intervention periods.|Rank sum test statistic|28662.0||||0.013|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The median duration of post-procedural antimicrobial prescriptions at site 1 were compared using the Wilcoxon rank-sum test.Type of statistical test||||0.013
70874533|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.11||0.417|TWO_SIDED|90.0|-1.0|2.9|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Family Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||2.9|-1.0|0.417
70955447|NCT00911937|141414769|SUPERIORITY_OR_OTHER||Least squares mean difference|1.86|STANDARD_ERROR_OF_MEAN|0.93||0.0458|TWO_SIDED|95.0|0.03|3.68||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: Social interaction domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||3.68|0.03|0.0458
70955448|NCT00911937|141414769|SUPERIORITY_OR_OTHER||Least squares mean difference|3.02|STANDARD_ERROR_OF_MEAN|1.17||0.01|TWO_SIDED|95.0|0.72|5.32||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: Total- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||5.32|0.72|0.0100
71146982|NCT04196777|141787302|OTHER|The Wilcoxon rank-sum test assessed whether the post-procedural antimicrobial duration significantly differed at site 2 between the baseline and intervention periods.|Rank sum test statistic|784.0||||0.14|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The median duration of post-procedural antimicrobial prescriptions at site 2 were compared using the Wilcoxon rank-sum test.||||0.14
71146983|NCT04196777|141787303|OTHER|We performed a logistic regression model that included patients across all 3 sites.|Odds Ratio (OR)|0.76||||0.04|TWO_SIDED|95.0|0.58|0.99|||Regression, Logistic|||To model this secondary outcome, we used a logistic regression model and a set of four explanatory variables: time, a binary indicator for an observation occurring within the intervention phase, an interaction term between these two main effects (time and intervention), and a binary indicator for the primary outcome. This last variable was included to assess the risk of these secondary outcomes in patients who were not exposed to post-procedural antimicrobials compared to those who were exposed.||0.99|0.58|0.04
71146984|NCT04196777|141787304|OTHER|We performed a logistic regression model that included patients across all 3 sites.|Odds Ratio (OR)|0.68|||<|0.01|TWO_SIDED|95.0|0.53|0.87|||Regression, Logistic|||To model this secondary outcome across all sites, we used a logistic regression model and a set of four explanatory variables: time, a binary indicator for an observation occurring within the intervention phase, an interaction term between these two main effects (time and intervention), and a binary indicator for the primary outcome.||0.87|0.53|<0.01
70874534|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|2.11||0.998|TWO_SIDED|90.0|-3.7|3.7|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Total Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||3.7|-3.7|0.998
70874535|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|2.16||0.353|TWO_SIDED|90.0|-5.8|1.7|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Total Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.7|-5.8|0.353
70874536|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|1.92||0.296|TWO_SIDED|90.0|-1.3|5.4|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Total Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||5.4|-1.3|0.296
70955449|NCT00700427|141414783|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||||||0.001
70955450|NCT00700427|141414785|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||||||0.002
70955451|NCT00700427|141414786|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for ADHD Imputed (Attributed) Index Score.|ANCOVA|||||||<0.001
71146985|NCT03367793|141787373|OTHER||f statistic|1.1||||0.341|TWO_SIDED|||||The threshold for statistical significance was 0.05.|Mixed Models Analysis|||It was calculated that 29 participants randomized in a 3x3 within-subject crossover design (repeated measures) achieves at least 89% power to detect an effect size of 0.25. Sample size was determined by a 2-sided f-test (alpha = 0.05) of the overall treatment effect based on a statistical simulation, simulating the repeated measures design. Assumptions included ICC of 0.3.||||0.341
71146986|NCT03367793|141787373|OTHER||least square means|0.31|||||TWO_SIDED|95.0|0.26|0.36|||||Additional model based estimates for 2-month estimated least square means in binocular visual acuity (logMAR) for PFST.|||0.36|0.26|
71146987|NCT03367793|141787373|OTHER||least square means|0.33|||||TWO_SIDED|95.0|0.27|0.38|||||Additional model based estimates for 2-month estimated least square means in binocular visual acuity (logMAR) for VSX.|||0.38|0.27|
71146988|NCT03367793|141787373|OTHER||least square means|0.34|||||TWO_SIDED|95.0|0.28|0.39|||||Additional model based estimates for 2-month estimated least square means in binocular visual acuity (logMAR) for Clinical Refraction.|||0.39|0.28|
71146989|NCT03367793|141787374|OTHER||f statistic|0.93||||0.41|TWO_SIDED|||||The threshold for statistical significance was 0.05.|f test|||It was calculated that 29 participants randomized in a 3x3 within-subject crossover design (repeated measures) achieves at least 89% power to detect an effect size of 0.25. Sample size was determined by a 2-sided f-test (alpha = 0.05) of the overall treatment effect based on a statistical simulation, simulating the repeated measures design. Assumptions included ICC of 0.3.||||0.410
71146990|NCT03367793|141787374|OTHER||least square means|0.35|||||TWO_SIDED|95.0|0.28|0.41|||||Additional model based estimates for initial visit estimated least square means in binocular visual acuity (logMAR) for PFST.|||0.41|0.28|
71146991|NCT03367793|141787374|OTHER||least square means|0.33|||||TWO_SIDED|95.0|0.26|0.39|||||Additional model based estimates for initial visit estimated least square means in binocular visual acuity (logMAR) for VSX.|||0.39|0.26|
70874537|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.95||0.841|TWO_SIDED|90.0|-1.8|1.5|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Social Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.5|-1.8|0.841
71146992|NCT03367793|141787374|OTHER||least square means|0.34|||||TWO_SIDED|95.0|0.28|0.41|||||Additional model based estimates for initial visit estimated least square means in binocular visual acuity (logMAR) for Clinical Refraction.|||0.41|0.28|
71146993|NCT03367793|141787375|OTHER||f statistic|1.09||||0.351|TWO_SIDED|||||The threshold for statistical significance was alpha=0.05.|f test|||It was calculated that 29 participants randomized in a 3x3 within-subject crossover design (repeated measures) achieves at least 89% power to detect an effect size of 0.25. Sample size was determined by a 2-sided f-test (alpha = 0.05) of the overall treatment effect based on a statistical simulation, simulating the repeated measures design. Assumptions included ICC of 0.3.||||0.351
70955452|NCT00700427|141414786|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Hyperactivity/Impulsivity Subscale Imputed Score.|ANCOVA|||||||0.002
70955453|NCT00700427|141414786|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for Inattention Subscale Imputed Score.|ANCOVA|||||||0.009
71146994|NCT03367793|141787375|OTHER||least square means|11.0|||||TWO_SIDED|95.0|9.3|12.7|||||Additional model based estimates for two-month wear time estimated least square means in spectacle wear-time (Hours) for PFST.|||12.7|9.3|
71146995|NCT03367793|141787375|OTHER||least square means|10.9|||||TWO_SIDED|95.0|9.2|12.6|||||Additional model based estimates for two-month wear time estimated least square means in spectacle wear-time (Hours) for VSX.|||12.6|9.2|
70955454|NCT00700427|141414786|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Total ADHD Symptom Imputed Score.|ANCOVA|||||||0.003
70955455|NCT00700427|141414787|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for ADHD Imputed (Attributed) Index Score.|ANCOVA|||||||<0.001
70955456|NCT00700427|141414787|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Hyperactivity/Impulsivity Subscale Imputed Score.|ANCOVA|||||||<0.001
70955457|NCT00700427|141414787|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Inattention Subscale Imputed Score.|ANCOVA|||||||<0.001
70955458|NCT00700427|141414787|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Total ADHD Symptom Imputed Score.|ANCOVA|||||||<0.001
70955459|NCT00700427|141414788|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANCOVA|||||||0.006
70874538|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.95||0.332|TWO_SIDED|90.0|-2.6|0.7|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Social Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.7|-2.6|0.332
70874539|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.81||0.359|TWO_SIDED|90.0|-0.6|2.2|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Social Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||2.2|-0.6|0.359
70874540|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.78||0.347|TWO_SIDED|90.0|-2.1|0.6|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Work Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.6|-2.1|0.347
70955460|NCT00700427|141414789|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANCOVA|||||||0.006
70955461|NCT00355199|141414796|SUPERIORITY||Hazard Ratio (HR)|0.99|||<|0.05|TWO_SIDED|95.0|0.66|1.48|||Regression, Cox||HR refers to R-HDS (R-CHOP is the reference level)|||1.48|0.66|<0.05
70955462|NCT00355199|141414798|SUPERIORITY||Hazard Ratio (HR)|0.6|||<|0.05|TWO_SIDED|95.0|0.29|1.21|||Regression, Cox||HR refers to R-HDS (R-CHOP is the reference level)|||1.21|0.29|<0.05
70955463|NCT00355199|141414799|SUPERIORITY||Hazard Ratio (HR)|0.93|||<|0.05|TWO_SIDED|95.0|0.57|1.52|||Regression, Cox||HR refers to R-HDS (R-CHOP is the reference level)|||1.52|0.57|<0.05
70955464|NCT02503852|141414803|SUPERIORITY|||||||0.032|||||||ANCOVA|||||||0.032
70955465|NCT02503852|141414803|OTHER|||||||0.0318||||||P value cited is the difference in non-vellus hair count between the low-dose ADRC NW3 group and the no-fat saline control at week 24|ANCOVA|||Non-vellus hair count in the low-dose ADRC group in the NW3 subgroup beginning at Week 6 (mean change from baseline persisting through weeks 12 , 24, and 52.||||0.0318
71146996|NCT03367793|141787375|OTHER||least square means|11.2|||||TWO_SIDED|95.0|9.5|12.9|||||Additional model based estimates for two-month wear time estimated least square means in spectacle wear-time (Hours) for Clinical Refraction.|||12.9|9.5|
71146997|NCT03367793|141787376|OTHER||f statistic|0.58||||0.562|TWO_SIDED||||||Mixed Models Analysis|||It was calculated that a sample size of n=28 yields 82% power to detect a difference of 0.4 in proportion of satisfaction (binary outcome of scores of '4' or '5' versus '1 to 3') in comparing two metrics using a two sided McNemar's test (alpha = 0.025 to account for pairwise testing).||||0.562
71146998|NCT03367793|141787376|OTHER||proportion|0.967|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 1 for PFST.|||||
70874541|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.8||0.041|TWO_SIDED|90.0|-3.2|-0.4|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Work Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||-0.4|-3.2|0.041
70874542|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.79||0.212|TWO_SIDED|90.0|-0.4|2.4|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Work Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||2.4|-0.4|0.212
70955466|NCT03231800|141414805|SUPERIORITY||Mean Difference (Final Values)|-5.24|STANDARD_ERROR_OF_MEAN|1.059|<|0.001|TWO_SIDED|95.0|-7.351|-3.137|||ANCOVA|||Least squares means, SEs, 95% CIs, and p-values were generated using an ANCOVA model, with treatment (dasotraline/placebo), mean SKAMP-CS at baseline, and site as fixed effects.||-3.137|-7.351|<0.001
70955467|NCT03231800|141414808|SUPERIORITY||Mean Difference (Final Values)|13.86|STANDARD_ERROR_OF_MEAN|5.612||0.016|TWO_SIDED|95.0|2.694|25.017|||ANCOVA|||||25.017|2.694|0.016
70955468|NCT03231800|141414809|SUPERIORITY||Mean Difference (Final Values)|12.06|STANDARD_ERROR_OF_MEAN|5.508||0.031|TWO_SIDED|95.0|1.105|23.017|||ANCOVA|||||23.017|1.105|0.031
70955469|NCT01670760|141414828|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.69||||0.69|TWO_SIDED||||||ANOVA|||||||0.69
71146999|NCT03367793|141787376|OTHER||proportion|0.933|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 1 for VSX.|||||
71147000|NCT03367793|141787376|OTHER||proportion|0.897|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 1 for Clinical Refraction.|||||
70955470|NCT00741390|141414834|SUPERIORITY_OR_OTHER||Percentage|99.59||||||95.0|98.09|99.59||||||||99.59|98.09|
70955471|NCT00741390|141414834|SUPERIORITY_OR_OTHER||Percentage|100.0||||||95.0|98.79|100.0||||||||100|98.79|
70955472|NCT00741390|141414834|SUPERIORITY_OR_OTHER||Percentage|100.0||||||95.0|97.61|100.0||||||||100|97.61|
70955473|NCT00741390|141414834|SUPERIORITY_OR_OTHER||Percentage|100.0||||||95.0|95.36|100.0||||||||100|95.36|
70955474|NCT00741390|141414834|SUPERIORITY_OR_OTHER||Percentage|100.0||||||95.0|95.13|100.0||||||||100|95.13|
70955475|NCT00741390|141414835|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.84|||<|0.001||95.0|6.8|10.84|||ANOVA|A general linear model with subject as a random effect and order within a pair as a fixed effect was fit to each study group.||||10.84|6.80|<0.001
70874543|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.69||0.954|TWO_SIDED|90.0|-1.2|1.2|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Family Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.2|-1.2|0.954
70874544|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.7||0.407|TWO_SIDED|90.0|-1.8|0.6|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Family Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.6|-1.8|0.407
70874545|NCT02310568|141233770|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.66||0.412|TWO_SIDED|90.0|-0.6|1.7|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Family Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.7|-0.6|0.412
70874546|NCT02310568|141233771|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.45||0.856|TWO_SIDED|90.0|-2.2|2.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||2.7|-2.2|0.856
70874547|NCT02310568|141233771|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.38||0.647|TWO_SIDED|90.0|-1.7|2.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||2.9|-1.7|0.647
70874548|NCT02310568|141233771|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.6||0.817|TWO_SIDED|90.0|-3.0|2.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||2.3|-3.0|0.817
70874549|NCT02310568|141233771|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.81||0.67|TWO_SIDED|90.0|-3.8|2.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||2.2|-3.8|0.670
70874550|NCT02310568|141233771|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.74||0.736|TWO_SIDED|90.0|-2.3|3.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||3.5|-2.3|0.736
70874551|NCT02310568|141233771|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|1.99||0.496|TWO_SIDED|90.0|-4.7|2.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||2.0|-4.7|0.496
70874552|NCT02310568|141233771|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.72||0.575|TWO_SIDED|90.0|-1.9|3.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||3.8|-1.9|0.575
70874553|NCT02310568|141233771|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.67||0.362|TWO_SIDED|90.0|-1.2|4.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||4.3|-1.2|0.362
70874554|NCT02310568|141233771|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|1.9||0.771|TWO_SIDED|90.0|-3.7|2.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||2.6|-3.7|0.771
70874555|NCT02310568|141233772|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75|||||TWO_SIDED|90.0|0.45|1.26|||Regression, Logistic|||(PF-06372865 7.5 mg - Placebo). Stage 1: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.||1.26|0.45|
70955476|NCT00741390|141414835|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.55||||0.003||95.0|3.63|8.55|||ANOVA|A general linear model with subject as a random effect and order within a pair as a fixed effect was fit to each study group.||||8.55|3.63|0.003
70955477|NCT00741390|141414835|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23||||0.46||95.0|-3.57|0.23|||ANOVA|A general linear model with subject as a random effect and order within a pair as a fixed effect was fit to each study group.||||0.23|-3.57|0.460
71147001|NCT03367793|141787377|OTHER||||||>|0.99|||||||Mixed Models Analysis|||It was calculated that a sample size of n=28 yields 82% power to detect a difference of 0.4 in proportion of satisfaction (binary outcome of scores of '4' or '5' versus '1 to 3') in comparing two metrics using a two sided McNemar's test (alpha = 0.025 to account for pairwise testing).||||>0.99
70874556|NCT02310568|141233772|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6|||||TWO_SIDED|90.0|0.23|1.54|||Regression, Logistic|||(PF-06372865 2.5 mg - Placebo). Stage 1: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.||1.54|0.23|
70874557|NCT02310568|141233772|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26|||||TWO_SIDED|90.0|0.69|2.32|||Regression, Logistic|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Stage 1: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.||2.32|0.69|
70874558|NCT02310568|141233772|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24|||||TWO_SIDED|90.0|0.27|5.78|||Regression, Logistic|||(PF-06372865 7.5 mg - Placebo). Stage 2: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.||5.78|0.27|
70874559|NCT02310568|141233772|SUPERIORITY_OR_OTHER||Odds Ratio, log|2.13|||||TWO_SIDED|90.0|0.19|24.51|||Regression, Logistic|||(PF-06372865 2.5 mg - Placebo). Stage 2: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.||24.51|0.19|
70874560|NCT02310568|141233772|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58|||||TWO_SIDED|90.0|0.16|2.09|||Regression, Logistic|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Stage 2: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.||2.09|0.16|
70874561|NCT02310568|141233773|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.801|TWO_SIDED|90.0|-0.4|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-0.4|0.801
70874562|NCT02310568|141233773|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.416|TWO_SIDED|90.0|-0.5|0.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.2|-0.5|0.416
70874563|NCT02310568|141233773|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.23||0.634|TWO_SIDED|90.0|-0.3|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.5|-0.3|0.634
70874564|NCT02310568|141233773|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.47|TWO_SIDED|90.0|-0.6|0.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.2|-0.6|0.470
70955478|NCT00741390|141414836|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.9||||0.017||95.0|1.14|4.9|||ANOVA|A general linear model with subject as a random effect and order within a pair as a fixed effect was fit to each study group.||||4.90|1.14|0.017
70874565|NCT02310568|141233773|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.683|TWO_SIDED|90.0|-0.5|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-0.5|0.683
70955479|NCT00741390|141414837|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|One proportion two-sided test; p=50%||Analysis consisted of a one proportion test for the 1st device in the lancing pair being preferred, out of the total number of times that a preference was stated. Note: lancing pairs in which no preference was stated or where data were missing were excluded from analysis. The null hypothesis for the one proportion test was that the 1st device in the lancing pair was preferred 50% of the times.||||0.001
70874566|NCT02310568|141233773|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.27||0.775|TWO_SIDED|90.0|-0.5|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.4|-0.5|0.775
70874567|NCT02310568|141233773|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.24||0.848|TWO_SIDED|90.0|-0.4|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-0.4|0.848
70874568|NCT02310568|141233773|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.23||0.49|TWO_SIDED|90.0|-0.2|0.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.6|-0.2|0.490
70955480|NCT00741390|141414837|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Fisher Exact|One proportion two-sided test; p=50%||Analysis consisted of a one proportion test for the 1st device in the lancing pair being preferred, out of the total number of times that a preference was stated. Note: lancing pairs in which no preference was stated or where data were missing were excluded from analysis. The null hypothesis for the one proportion test was that the 1st device in the lancing pair was preferred 50% of the times.||||0.002
70874569|NCT02310568|141233773|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.27||0.433|TWO_SIDED|90.0|-0.7|0.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.2|-0.7|0.433
70874570|NCT02310568|141233773|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.25||0.796|TWO_SIDED|90.0|-0.4|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.5|-0.4|0.796
70874571|NCT02310568|141233773|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.25||0.624|TWO_SIDED|90.0|-0.3|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.5|-0.3|0.624
70955481|NCT00741390|141414837|SUPERIORITY_OR_OTHER|||||||0.761||95.0|||||Fisher Exact|One proportion two-sided test; p=50%||Analysis consisted of a one proportion test for the 1st device in the lancing pair being preferred, out of the total number of times that a preference was stated. Note: lancing pairs in which no preference was stated or where data were missing were excluded from analysis. The null hypothesis for the one proportion test was that the 1st device in the lancing pair was preferred 50% of the times.||||0.761
70955482|NCT00741390|141414837|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Fisher Exact|One proportion two-sided test; p=50%||Analysis consisted of a one proportion test for the 1st device in the lancing pair being preferred, out of the total number of times that a preference was stated. Note: lancing pairs in which no preference was stated or where data were missing were excluded from analysis. The null hypothesis for the one proportion test was that the 1st device in the lancing pair was preferred 50% of the times.||||0.004
70955483|NCT01056718|141414844|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of treatment. Each subject served as his/her own control.||||<0.05
70955484|NCT01056718|141414845|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
70955485|NCT01056718|141414846|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
70955486|NCT01056718|141414847|SUPERIORITY_OR_OTHER||||||=|0.078|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.078
70955487|NCT01056718|141414848|SUPERIORITY_OR_OTHER||||||=|0.186|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.186
70955488|NCT01056718|141414849|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
70955489|NCT01056718|141414850|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
70955490|NCT01056718|141414851|SUPERIORITY_OR_OTHER||||||=|0.06|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.06
70955491|NCT01056718|141414852|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
70955492|NCT01056718|141414853|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
70955493|NCT01056718|141414854|SUPERIORITY_OR_OTHER||||||=|0.85|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.85
70955494|NCT01056718|141414855|SUPERIORITY_OR_OTHER||||||=|0.4|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.40
70955495|NCT01056718|141414856|SUPERIORITY_OR_OTHER||||||=|0.64|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.64
70955496|NCT01056718|141414857|SUPERIORITY_OR_OTHER||||||=|0.49|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.49
70955497|NCT01056718|141414858|SUPERIORITY_OR_OTHER||||||=|0.47|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.47
70955498|NCT01056718|141414859|SUPERIORITY_OR_OTHER||||||=|0.55|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.55
70955499|NCT01056718|141414860|SUPERIORITY_OR_OTHER||||||=|0.64|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.64
71147002|NCT03367793|141787377|OTHER||proportion|0.967|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 2 for PFST.|||||
70955500|NCT01056718|141414861|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
70955501|NCT01056718|141414862|SUPERIORITY_OR_OTHER||||||=|0.526|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.526
70955502|NCT01056718|141414863|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
70955503|NCT01056718|141414864|SUPERIORITY_OR_OTHER||||||=|0.925|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.925
70955504|NCT01056718|141414865|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
70955505|NCT01056718|141414866|SUPERIORITY_OR_OTHER||||||=|0.458|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.458
70955506|NCT01056718|141414867|SUPERIORITY_OR_OTHER||||||=|0.561|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.561
70955507|NCT01056718|141414868|SUPERIORITY_OR_OTHER||||||=|0.734|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.734
71147003|NCT03367793|141787377|OTHER||proportion|0.967|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 2 for VSX.|||||
70955508|NCT01056718|141414869|SUPERIORITY_OR_OTHER||||||=|0.129|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.129
70955509|NCT05086276|141414871|SUPERIORITY||Odds Ratio (OR)|1.4||||0.525|TWO_SIDED|95.0|0.51|3.73||P value for statistical significance is \<0.05|Chi-squared|||||3.73|0.51|0.525
70955510|NCT05086276|141414871|SUPERIORITY||Mean Difference (Final Values)|3.6||||0.525|TWO_SIDED|95.0|-7.52|14.71||P value for statistical significance is \<0.05|Chi-squared|||||14.71|-7.52|0.525
70955511|NCT05086276|141414872|SUPERIORITY||Least squares mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.491||0.973|TWO_SIDED|95.0|-0.954|0.987||P value for statistical significance is \<0.05|Mixed Models Analysis|||||0.987|-0.954|0.973
70955512|NCT05086276|141414874|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.16|TWO_SIDED|95.0|-0.06|0.34||P value for statistical significance is \<0.05|ANCOVA|||||0.34|-0.06|0.160
70955513|NCT05086276|141414875|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.1||0.027|TWO_SIDED|95.0|0.03|0.41||P value for statistical significance is \<0.05|ANCOVA|||||0.41|0.03|0.027
70955514|NCT00777088|141414876|NON_INFERIORITY|The cumulative rate of ipsilateral stroke or neurologic death is not ≥ 20% at 180-day clinical follow-up and the cumulative rate of ipsilateral stroke or neurovascular death is not ≥ 25% at 5-year clinical follow-up|||||<|0.001|||||||Bayesian|||||||<.001
70955515|NCT00777088|141414877|NON_INFERIORITY_OR_EQUIVALENCE|The rate of complete IA occlusion without major parent artery stenosis exceeds 50% with a posterior probability \>0.975.|||||<|0.001|||||||Bayesian|||||||<0.001
70955516|NCT00760474|141414891|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_DEVIATION|0.157||0.083||||||Significance was set at p \<0.05.|t-test, 2 sided||Mean difference between the pre-dose (baseline) and post-dose values calculated as post-dose minus pre-dose (post minus pre).|Glu/Cr posterior insula||||0.083
70955517|NCT00760474|141414891|SUPERIORITY_OR_OTHER_LEGACY|||||||0.436||95.0||||Significance was set at p \<0.05.|t-test, 2 sided|||Glu/Cr posterior insula||||0.436
70955518|NCT00760474|141414891|SUPERIORITY_OR_OTHER_LEGACY|||||||0.306||95.0|||||t-test, 2 sided|Significance was set at p \<0.05.||Gln/Cr posterior insula||||0.306
71147004|NCT03367793|141787377|OTHER||proportion|0.966|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 2 for Clinical Refraction.|||||
71147005|NCT03367793|141787378|OTHER||||||>|0.99|||||||Mixed Models Analysis|||It was calculated that a sample size of n=28 yields 82% power to detect a difference of 0.4 in proportion of satisfaction (binary outcome of scores of '4' or '5' versus '1 to 3') in comparing two metrics using a two sided McNemar's test (alpha = 0.025 to account for pairwise testing).||||>0.99
71147006|NCT03367793|141787378|OTHER||proportion|0.967|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 3 for PFST.|||||
71147007|NCT03367793|141787378|OTHER||proportion|0.967|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 3 for VSX.|||||
71147008|NCT03367793|141787378|OTHER||proportion|0.966|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 3 for Clinical Refraction.|||||
71147009|NCT02435992|141787379|SUPERIORITY||Odds Ratio (OR)|3.586||||0.0001|TWO_SIDED|95.0|1.938|6.636|||Cochran-Mantel-Haenszel|||||6.636|1.938|0.0001
71147010|NCT02435992|141787380|SUPERIORITY||Odds Ratio (OR)|2.755||||0.0001|TWO_SIDED|95.0|1.767|4.294|||Cochran-Mantel-Haenszel|||||4.294|1.767|0.0001
71147011|NCT01761877|141787391|OTHER|Mixed Models Analysis|||||<|0.05||||||A p value was calculated for change in breast density from baseline to 12 months separately for each study arm.|Mixed Models Analysis|||The study was designed to assess change in breast density using fat/water MRI after 12 months of sulindac intervention in postmenopausal breast cancer patients taking aromatase inhibitors for the treatment of estrogen receptor positive breast cancer. A non-randomized observation arm was included with the same eligibility criteria to assess change in breast density over 12 months using the fat/water MRI method of quantifying breast density. Change was examined separately for each arm.||||<0.05
71147012|NCT01761877|141787392|OTHER||||||<|0.05||||||A p value of \<0.05 was selected for change in each arm. The study did not include a direct comparison between the two arms.|Mixed Models Analysis|||||||<0.05
71147013|NCT01761877|141787393|OTHER||||||<|0.05|TWO_SIDED|95.0||||A p value of \<0.05 was selected for change in each arm. The study did not include a direct comparison between the two arms.|Mixed Models Analysis|||||||<0.05
71147014|NCT03697252|141787405|SUPERIORITY||LS mean difference|-11.56|||<|0.0001|TWO_SIDED|95.0|-16.07|-7.05|||Mixed model for repeated measures||||Statistics are from a mixed model for repeated measures (MMRM). The model includes the treatment group (KarXT or placebo), visit, and the interaction between the treatment group and visit as fixed factors, and baseline PANSS total score, site, age, and gender as covariates. An unstructured covariance matrix is used to model the correlation among repeated measurements and the denominator degrees of freedom are computed using the Kenward-Roger method.|-7.05|-16.07|<0.0001
71147015|NCT03697252|141787407|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of KarXT and Placebo at Week 5||||<0.001
71147016|NCT01353898|141787450|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.62|||||||||||||Geometric mean ratio of HIV-1/Healthy. Analyzed using a linear mixed model with fixed factors: dose, health-status and the interaction between dose and health-status.|Compared to historical data for AUC0-24hrs measured on Day 7 for healthy participants treated with 200 mg MK-1972 once daily||||
71147017|NCT01353898|141787450|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.84|||||||||||||Geometric mean ratio of HIV-1/Healthy. Analyzed using a linear mixed model with fixed factors: dose, health-status and the interaction between dose and health-status.|Compared to historical data for AUC0-24hrs measured on Day 7 for healthy participants treated with 800 mg MK-1972 once daily||||
71147018|NCT01353898|141787451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||||||||||||||||
71147019|NCT01353898|141787451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||||||||||||||||
71147020|NCT01353898|141787451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||||||||||||||||
71147021|NCT01353898|141787451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||||||||||||||||
71147022|NCT01353898|141787451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.83||||||||||||||||||
71147023|NCT04973449|141787481|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.08|1.32||||||The analyses were derived using analysis of covariance (ANCOVA).||1.32|1.08|
71147024|NCT04973449|141787482|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group is \> 0.67.|GMT ratio|1.02|||||TWO_SIDED|95.0|0.9|1.14||||||The analyses were derived using ANCOVA.||1.14|0.90|
71147025|NCT04973449|141787483|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|1.68|||||TWO_SIDED|95.0|-3.11|6.49||||||The analyses were derived using ANCOVA.||6.49|-3.11|
71147026|NCT04973449|141787484|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group is \> 0.67.|GMT ratio|3.47|||||TWO_SIDED|95.0|3.09|3.89||||||The analyses were derived using ANCOVA.||3.89|3.09|
71147027|NCT04973449|141787487|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|3.21|||||TWO_SIDED|95.0|3.06|3.36||||||The analyses were derived using ANCOVA.||3.36|3.06|
71147028|NCT04973449|141787488|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.5|||||TWO_SIDED|95.0|0.45|0.56||||||The analyses were derived using ANCOVA.||0.56|0.45|
71147029|NCT04973449|141787489|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.31|||||TWO_SIDED|95.0|0.27|0.35||||||The analyses were derived using ANCOVA.||0.35|0.27|
71147030|NCT04973449|141787490|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.41|||||TWO_SIDED|95.0|1.25|1.58||||||The analyses were derived using ANCOVA.||1.58|1.25|
71147031|NCT04973449|141787491|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.84|||||TWO_SIDED|95.0|1.63|2.08||||||The analyses were derived using ANCOVA.||2.08|1.63|
71147032|NCT04973449|141787492|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.88|||||TWO_SIDED|95.0|0.78|0.99||||||The analyses were derived using ANCOVA.||0.99|0.78|
71147033|NCT04973449|141787493|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.87|||||TWO_SIDED|95.0|0.78|0.97||||||The analyses were derived using ANCOVA.||0.97|0.78|
71147034|NCT04973449|141787494|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.95|||||TWO_SIDED|95.0|0.83|1.08||||||The analyses were derived using ANCOVA.||1.08|0.83|
70955519|NCT00760474|141414891|SUPERIORITY_OR_OTHER_LEGACY|||||||0.809||95.0|||||t-test, 2 sided|Significance was set at p \<0.05.||Gln/Cr posterior insula||||0.809
70955520|NCT00760474|141414891|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.116|STANDARD_DEVIATION|0.177||0.016|||||||t-test, 2 sided|Significance was set at p \<0.05.|Mean difference between the pre-dose (baseline) and post-dose values calculated as post-dose minus pre-dose (post minus pre).|Glx/Cr posterior insula||||0.016
70955521|NCT00760474|141414891|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.029|STANDARD_DEVIATION|0.308||0.708||||||Significance was set at p \<0.05.|t-test, 2 sided||Mean difference between the pre-dose (baseline) and post-dose values calculated as post-dose minus pre-dose (post minus pre).|Glx/Cr posterior insula||||0.708
70955522|NCT00760474|141414891|SUPERIORITY_OR_OTHER_LEGACY|||||||0.809||95.0||||Significance was set at p \<0.050.|t-test, 2 sided|||Glu/Cr anterior insula||||0.809
70955523|NCT00760474|141414891|SUPERIORITY_OR_OTHER_LEGACY|||||||0.154||95.0||||Significance was set at p \<0.05.|t-test, 2 sided|||Glu/Cr anterior insula||||0.154
70955524|NCT00760474|141414891|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96||95.0|||||t-test, 2 sided|Significance was set at p \<0.05.||Gln/Cr anterior insula||||0.960
70955525|NCT00760474|141414891|SUPERIORITY_OR_OTHER_LEGACY|||||||0.937||95.0|||||t-test, 2 sided|Significance was set at p \<0.05.||Gln/Cr anterior insula||||0.937
70955526|NCT00760474|141414891|SUPERIORITY_OR_OTHER_LEGACY|||||||0.897||95.0||||Significance was set at p \<0.05.|t-test, 2 sided|||Glx/Cr anterior insula||||0.897
70955527|NCT00760474|141414891|SUPERIORITY_OR_OTHER_LEGACY|||||||0.309||95.0||||Significance was set at p \<0.05.|t-test, 2 sided|||Glx/Cr anterior insula||||0.309
70955528|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.032||||0.6347|TWO_SIDED|95.0|-0.1081|0.1714||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||Anterior Cingulate||0.1714|-0.1081|0.6347
70955529|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.079||||0.5181|TWO_SIDED|95.0|-0.3356|0.1771||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||BA22||0.1771|-0.3356|0.5181
70955530|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.072||||0.2987|TWO_SIDED|95.0|-0.2161|0.0714||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||BA40||0.0714|-0.2161|0.2987
70955531|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.029||||0.5151|TWO_SIDED|95.0|-0.064|0.1219||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_anIns||0.1219|-0.0640|0.5151
70955532|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.081||||0.2369|TWO_SIDED|95.0|-0.2228|0.0599||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Amygdala||0.0599|-0.2228|0.2369
70955533|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.077||||0.0758|TWO_SIDED|95.0|-0.1642|0.0092||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Cerebellum||0.0092|-0.1642|0.0758
70955534|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.025||||0.4609|TWO_SIDED|95.0|-0.0947|0.0452||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_DLPFC||0.0452|-0.0947|0.4609
70955535|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.111||||0.3813|TWO_SIDED|95.0|-0.3745|0.1524||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Mid Insula||0.1524|-0.3745|0.3813
70955536|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.02||||0.72|TWO_SIDED|95.0|-0.0964|0.1361||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Mid Temporal Pole||0.1361|-0.0964|0.7200
70955537|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.168||||0.2099|TWO_SIDED|95.0|-0.1065|0.4434||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Orbito Front||0.4434|-0.1065|0.2099
71147035|NCT04973449|141787495|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|6.56|||||TWO_SIDED|95.0|5.82|7.4||||||The analyses were derived using ANCOVA.||7.40|5.82|
71147036|NCT04973449|141787496|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|2.22|||||TWO_SIDED|95.0|1.99|2.47||||||The analyses were derived using ANCOVA.||2.47|1.99|
71147037|NCT04973449|141787497|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group is \> 0.67.|GMT ratio|4.35|||||TWO_SIDED|95.0|3.86|4.9||||||The analyses were derived using ANCOVA.||4.90|3.86|
71147038|NCT04973449|141787498|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.25|||||TWO_SIDED|95.0|1.13|1.39||||||The analyses were derived using ANCOVA.||1.39|1.13|
71147039|NCT04973449|141787499|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|4.42|||||TWO_SIDED|95.0|3.85|5.08||||||The analyses were derived using ANCOVA.||5.08|3.85|
71147040|NCT04973449|141787500|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-1.24|||||TWO_SIDED|95.0|-6.62|3.84||||||The analyses were derived using ANCOVA.||3.84|-6.62|
71147041|NCT04973449|141787501|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|16.86|||||TWO_SIDED|95.0|10.18|23.32||||||The analyses were derived using ANCOVA.||23.32|10.18|
70874572|NCT02310568|141233773|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.28||0.844|TWO_SIDED|90.0|-0.5|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.4|-0.5|0.844
70874573|NCT02310568|141233773|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.5||0.743|TWO_SIDED|90.0|-0.7|1.0|||LS Mean Difference|||(PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.0|-0.7|0.743
70874574|NCT02310568|141233773|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.48||0.356|TWO_SIDED|90.0|-1.3|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.4|-1.3|0.356
70874575|NCT02310568|141233773|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.45||0.18|TWO_SIDED|90.0|-0.2|1.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.4|-0.2|0.180
70874576|NCT02310568|141233773|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.53||0.589|TWO_SIDED|90.0|-0.6|1.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.2|-0.6|0.589
70874577|NCT02310568|141233773|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.51||0.873|TWO_SIDED|90.0|-0.8|1.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.0|-0.8|0.873
70874578|NCT02310568|141233773|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.48||0.667|TWO_SIDED|90.0|-0.6|1.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.0|-0.6|0.667
70874579|NCT02310568|141233773|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.47||0.548|TWO_SIDED|90.0|-0.5|1.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.1|-0.5|0.548
70874580|NCT02310568|141233773|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.45||0.567|TWO_SIDED|90.0|-1.0|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.5|-1.0|0.567
70874581|NCT02310568|141233773|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.42||0.208|TWO_SIDED|90.0|-0.2|1.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.3|-0.2|0.208
70874582|NCT02310568|141233773|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.6||0.858|TWO_SIDED|90.0|-1.2|0.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.9|-1.2|0.858
71147042|NCT04973449|141787502|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-18.12|||||TWO_SIDED|95.0|-24.22|-12.07||||||The analyses were derived using ANCOVA.||-12.07|-24.22|
71147043|NCT04973449|141787503|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-0.02|||||TWO_SIDED|95.0|-7.28|7.23||||||The analyses were derived using ANCOVA.||7.23|-7.28|
71147044|NCT04973449|141787504|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|31.36|||||TWO_SIDED|95.0|24.44|37.82||||||The analyses were derived using ANCOVA.||37.82|24.44|
71147045|NCT04973449|141787505|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-3.55|||||TWO_SIDED|95.0|-9.4|1.9||||||The analyses were derived using ANCOVA.||1.90|-9.40|
71147046|NCT04973449|141787506|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|23.01|||||TWO_SIDED|95.0|15.41|30.23||||||The analyses were derived using ANCOVA.||30.23|15.41|
71147047|NCT04973449|141787507|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-34.24|||||TWO_SIDED|95.0|-40.77|-27.45||||||The analyses were derived using ANCOVA.||-27.45|-40.77|
71147048|NCT04973449|141787508|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|6.96|||||TWO_SIDED|95.0|-1.31|15.1||||||The analyses were derived using ANCOVA.||15.10|-1.31|
71147049|NCT04973449|141787509|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|29.05|||||TWO_SIDED|95.0|21.76|35.81||||||The analyses were derived using ANCOVA.||35.81|21.76|
71147050|NCT04973449|141787511|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.36|||||TWO_SIDED|95.0|1.3|1.42||||||The analyses were derived using ANCOVA.||1.42|1.30|
71147051|NCT04973449|141787512|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.76|||||TWO_SIDED|95.0|0.7|0.81||||||The analyses were derived using ANCOVA.||0.81|0.70|
70874583|NCT02310568|141233773|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.58||0.329|TWO_SIDED|90.0|-1.7|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-1.7|0.329
70874584|NCT02310568|141233773|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.54||0.272|TWO_SIDED|90.0|-0.4|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-0.4|0.272
71147052|NCT04973449|141787513|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|3.87|||||TWO_SIDED|95.0|3.4|4.39||||||The analyses were derived using ANCOVA.||4.39|3.40|
71147053|NCT04973449|141787514|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.67|||||TWO_SIDED|95.0|0.64|0.7||||||The analyses were derived using ANCOVA.||0.70|0.64|
70955538|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.003||||0.9551|TWO_SIDED|95.0|-0.1047|0.0992||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||PAG||0.0992|-0.1047|0.9551
71147054|NCT04973449|141787515|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|0.58|||||TWO_SIDED|95.0|-0.61|2.09||||||The analyses were derived using ANCOVA.||2.09|-0.61|
71147055|NCT04973449|141787516|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-35.18|||||TWO_SIDED|95.0|-41.46|-28.44||||||The analyses were derived using ANCOVA.||-28.44|-41.46|
71147056|NCT04973449|141787517|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-24.93|||||TWO_SIDED|95.0|-31.06|-18.56||||||The analyses were derived using ANCOVA.||-18.56|-31.06|
71147057|NCT04973449|141787518|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-0.02|||||TWO_SIDED|95.0|-1.63|1.56||||||The analyses were derived using ANCOVA.||1.56|-1.63|
71147058|NCT04973449|141787519|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-19.18|||||TWO_SIDED|95.0|-23.8|-14.98||||||The analyses were derived using ANCOVA.||-14.98|-23.80|
71147059|NCT04973449|141787520|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|39.18|||||TWO_SIDED|95.0|32.68|45.21||||||The analyses were derived using ANCOVA.||45.21|32.68|
71147060|NCT04973449|141787521|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|0.0|||||TWO_SIDED|95.0|-1.62|1.62||||||The analyses were derived using ANCOVA.||1.62|-1.62|
70955539|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.0||||0.994|TWO_SIDED|95.0|-0.0855|0.0848||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||Posterior Insula||0.0848|-0.0855|0.9940
70955540|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.049||||0.4291|TWO_SIDED|95.0|-0.1792|0.0806||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Posterior Cingulate||0.0806|-0.1792|0.4291
70955541|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.027||||0.467|TWO_SIDED|95.0|-0.0496|0.1028||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Precuneus||0.1028|-0.0496|0.4670
70955542|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.044||||0.4443|TWO_SIDED|95.0|-0.0752|0.1624||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Putamen||0.1624|-0.0752|0.4443
70955543|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.127||||0.2823|TWO_SIDED|95.0|-0.3704|0.1165||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_S2||0.1165|-0.3704|0.2823
70955544|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.105||||0.1369|TWO_SIDED|95.0|-0.2481|0.0378||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_DLPFC||0.0378|-0.2481|0.1369
70955545|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.078||||0.2376|TWO_SIDED|95.0|-0.0573|0.2127||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_anIns||0.2127|-0.0573|0.2376
70955546|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.153||||0.0968|TWO_SIDED|95.0|-0.3365|0.0313||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Amygdala||0.0313|-0.3365|0.0968
70955547|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.023||||0.572|TWO_SIDED|95.0|-0.061|0.1062||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_BA23\_base||0.1062|-0.0610|0.5720
70955548|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.027||||0.5822|TWO_SIDED|95.0|-0.1303|0.0761||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_IPL\_base||0.0761|-0.1303|0.5822
70955549|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.044||||0.6851|TWO_SIDED|95.0|-0.2697|0.1824||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Insula\_base||0.1824|-0.2697|0.6851
70955550|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.013||||0.8656|TWO_SIDED|95.0|-0.1699|0.1446||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Mid Insula||0.1446|-0.1699|0.8656
70955551|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.094||||0.1562|TWO_SIDED|95.0|-0.2296|0.0407||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Mid Front\_DLPFC||0.0407|-0.2296|0.1562
70955552|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.012||||0.7752|TWO_SIDED|95.0|-0.0991|0.0754||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Mid Temporal Pole||0.0754|-0.0991|0.7752
70955553|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.01||||0.9182|TWO_SIDED|95.0|-0.1912|0.2109||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Orbito Front||0.2109|-0.1912|0.9182
70955554|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.022||||0.6544|TWO_SIDED|95.0|-0.0829|0.1278||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_PAG||0.1278|-0.0829|0.6544
70955555|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.087||||0.0813|TWO_SIDED|95.0|-0.0123|0.1863||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_pIns||0.1863|-0.0123|0.0813
70955556|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.052||||0.4605|TWO_SIDED|95.0|-0.0956|0.2004||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_pIns||0.2004|-0.0956|0.4605
71147061|NCT04973449|141787522|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.52|||||TWO_SIDED|95.0|0.45|0.59||||||The analyses were derived using ANCOVA.||0.59|0.45|
71147062|NCT04973449|141787523|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.76|||||TWO_SIDED|95.0|0.68|0.86||||||The analyses were derived using ANCOVA.||0.86|0.68|
71147063|NCT04973449|141787524|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.6|||||TWO_SIDED|95.0|1.43|1.79||||||The analyses were derived using ANCOVA.||1.79|1.43|
71147064|NCT04973449|141787525|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.75|||||TWO_SIDED|95.0|0.67|0.85||||||The analyses were derived using ANCOVA.||0.85|0.67|
70874585|NCT02310568|141233773|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.33||0.946|TWO_SIDED|90.0|-0.6|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.5|-0.6|0.946
71147065|NCT04973449|141787526|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-18.1|||||TWO_SIDED|95.0|-24.13|-12.1||||||The analyses were derived using ANCOVA.||-12.10|-24.13|
71147066|NCT04973449|141787527|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|14.5|||||TWO_SIDED|95.0|7.07|21.71||||||The analyses were derived using ANCOVA.||21.71|7.07|
71147067|NCT04973449|141787528|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-18.1|||||TWO_SIDED|95.0|-24.13|-12.1||||||The analyses were derived using ANCOVA.||-12.10|-24.13|
71147068|NCT04973449|141787529|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|16.87|||||TWO_SIDED|95.0|10.15|23.4||||||The analyses were derived using ANCOVA.||23.40|10.15|
71147069|NCT04973449|141787530|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|0.0|||||TWO_SIDED|95.0|-7.21|7.21||||||The analyses were derived using ANCOVA.||7.21|-7.21|
71147070|NCT04973449|141787531|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|2.0|||||TWO_SIDED|95.0|1.75|2.28||||||The analyses were derived using ANCOVA.||2.28|1.75|
71147071|NCT04973449|141787532|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|2.96|||||TWO_SIDED|95.0|2.64|3.32||||||The analyses were derived using ANCOVA.||3.32|2.64|
71147072|NCT04973449|141787533|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.51|||||TWO_SIDED|95.0|1.35|1.69||||||The analyses were derived using ANCOVA.||1.69|1.35|
71147073|NCT04973449|141787534|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.85|||||TWO_SIDED|95.0|0.78|0.94||||||The analyses were derived using ANCOVA.||0.94|0.78|
70874586|NCT02310568|141233773|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.407|TWO_SIDED|90.0|-0.8|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.3|-0.8|0.407
70874587|NCT02310568|141233773|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.31||0.436|TWO_SIDED|90.0|-0.3|0.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.8|-0.3|0.436
70874588|NCT02310568|141233774|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.325|TWO_SIDED|90.0|-0.6|0.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.1|-0.6|0.325
70874589|NCT02310568|141233774|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.996|TWO_SIDED|90.0|-0.3|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-0.3|0.996
70874590|NCT02310568|141233774|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.377|TWO_SIDED|90.0|-0.6|0.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.2|-0.6|0.377
70874591|NCT02310568|141233774|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.24||0.291|TWO_SIDED|90.0|-0.7|0.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.1|-0.7|0.291
70874592|NCT02310568|141233774|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.24||0.925|TWO_SIDED|90.0|-0.4|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.4|-0.4|0.925
70955557|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.081||||0.3136|TWO_SIDED|95.0|-0.2484|0.0856||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Posterior Cingulate||0.0856|-0.2484|0.3136
70874593|NCT02310568|141233774|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.27||0.39|TWO_SIDED|90.0|-0.7|0.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.2|-0.7|0.390
70874594|NCT02310568|141233774|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.29||0.502|TWO_SIDED|90.0|-0.7|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-0.7|0.502
70874595|NCT02310568|141233774|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.29||0.348|TWO_SIDED|90.0|-0.2|0.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.7|-0.2|0.348
70874596|NCT02310568|141233774|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.33||0.16|TWO_SIDED|90.0|-1.0|0.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.1|-1.0|0.160
70874597|NCT02310568|141233774|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.965|TWO_SIDED|90.0|-0.5|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.5|-0.5|0.965
70874598|NCT02310568|141233774|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.389|TWO_SIDED|90.0|-0.2|0.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.7|-0.2|0.389
70874599|NCT02310568|141233774|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.34||0.433|TWO_SIDED|90.0|-0.8|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-0.8|0.433
70874600|NCT02310568|141233774|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.94|TWO_SIDED|90.0|-0.9|0.8|||LS Mean Difference|||(PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.8|-0.9|0.940
70874601|NCT02310568|141233774|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.49||0.757|TWO_SIDED|90.0|-1.0|0.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.7|-1.0|0.757
70874602|NCT02310568|141233774|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.46||0.836|TWO_SIDED|90.0|-0.7|0.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.9|-0.7|0.836
70874603|NCT02310568|141233774|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.56||0.827|TWO_SIDED|90.0|-0.9|1.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.1|-0.9|0.827
70874604|NCT02310568|141233774|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.55||0.507|TWO_SIDED|90.0|-0.6|1.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.3|-0.6|0.507
70874605|NCT02310568|141233774|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.51||0.632|TWO_SIDED|90.0|-1.1|0.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.6|-1.1|0.632
70874606|NCT02310568|141233774|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.51||0.442|TWO_SIDED|90.0|-0.5|1.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.3|-0.5|0.442
70874607|NCT02310568|141233774|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.5||0.643|TWO_SIDED|90.0|-1.1|0.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.6|-1.1|0.643
70955558|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.0||||0.9929|TWO_SIDED|95.0|-0.0885|0.0893||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Precuneus||0.0893|-0.0885|0.9929
70874608|NCT02310568|141233774|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.47||0.188|TWO_SIDED|90.0|-0.2|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-0.2|0.188
70874609|NCT02310568|141233774|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.65||0.701|TWO_SIDED|90.0|-1.4|0.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.9|-1.4|0.701
70874610|NCT02310568|141233774|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.63||0.271|TWO_SIDED|90.0|-1.8|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.4|-1.8|0.271
70874611|NCT02310568|141233774|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.6||0.445|TWO_SIDED|90.0|-0.6|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-0.6|0.445
70955559|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.002||||0.949|TWO_SIDED|95.0|-0.0815|0.0767||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Precuneus\_base||0.0767|-0.0815|0.9490
71147074|NCT04973449|141787535|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-41.2|||||TWO_SIDED|95.0|-47.57|-34.41||||||The analyses were derived using ANCOVA.||-34.41|-47.57|
71147075|NCT04973449|141787536|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|6.05|||||TWO_SIDED|95.0|-1.81|13.77||||||The analyses were derived using ANCOVA.||13.77|-1.81|
71147076|NCT04973449|141787537|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-26.56|||||TWO_SIDED|95.0|-33.1|-19.94||||||The analyses were derived using ANCOVA.||-19.94|-33.10|
71147077|NCT04973449|141787538|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|30.69|||||TWO_SIDED|95.0|22.94|37.9||||||The analyses were derived using ANCOVA.||37.90|22.94|
71147078|NCT04973449|141787539|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|14.64|||||TWO_SIDED|95.0|6.36|22.64||||||The analyses were derived using ANCOVA.||22.64|6.36|
71147079|NCT04973449|141787540|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.84|||||TWO_SIDED|95.0|0.74|0.96||||||The analyses were derived using analysis of covariance (ANCOVA).||0.96|0.74|
71147080|NCT04973449|141787541|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.71|||||TWO_SIDED|95.0|1.62|1.8||||||The analyses were derived using ANCOVA.||1.80|1.62|
71147081|NCT04973449|141787542|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.5|||||TWO_SIDED|95.0|0.44|0.56||||||The analyses were derived using ANCOVA.||0.56|0.44|
71147082|NCT04973449|141787543|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.38|||||TWO_SIDED|95.0|0.32|0.44||||||The analyses were derived using ANCOVA.||0.44|0.32|
71147083|NCT03373240|141787723|OTHER|Examining stop signal reaction time changed across the 4-week training period|Mean Difference (Net)|-8.62|STANDARD_ERROR_OF_MEAN|2.79||0.003|TWO_SIDED|95.0|-14.17|-3.06|||Mixed Models Analysis|||||-3.06|-14.17|.003
71147084|NCT03373240|141787724|SUPERIORITY||Mean Difference (Net)|-0.075|STANDARD_ERROR_OF_MEAN|0.127||0.049|TWO_SIDED|95.0|-0.333|0.184|||ANOVA|||||.184|-.333|.049
71147085|NCT03373240|141787725|SUPERIORITY||Mean Difference (Net)|-1.914|STANDARD_ERROR_OF_MEAN|1.011||0.236|TWO_SIDED|95.0|-3.965|0.136|||ANOVA|||||.136|-3.965|.236
71147086|NCT03373240|141787726|OTHER|Examining whether percentage of risky choices decreased across the 4-wwek training period.|Mean Difference (Net)|-1.62|STANDARD_ERROR_OF_MEAN|0.77||0.039|TWO_SIDED|95.0|-3.15|-0.08|||Mixed Models Analysis|||||-.08|-3.15|.039
71147087|NCT03373240|141787727|OTHER||Mean Difference (Net)|-1.77|STANDARD_ERROR_OF_MEAN|0.82||0.035|TWO_SIDED|95.0|-3.4|-0.13|||Mixed Models Analysis|||||-.13|-3.40|.035
71147088|NCT03373240|141787728|OTHER||Mean Difference (Net)|4.26|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|95.0|3.12|5.39|||Mixed Models Analysis|||||5.39|3.12|<.001
71147089|NCT03373240|141787729|SUPERIORITY||Mean Difference (Net)|0.933|STANDARD_ERROR_OF_MEAN|0.403||0.008|TWO_SIDED|95.0|0.111|1.755|||ANOVA|||||1.755|.111|.008
70955560|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.065||||0.5668|TWO_SIDED|95.0|-0.3019|0.1722||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||Superior Temporal||0.1722|-0.3019|0.5668
70955561|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.0||||0.9958|TWO_SIDED|95.0|-0.1398|0.1391||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Premotor||0.1391|-0.1398|0.9958
70955562|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.057||||0.3379|TWO_SIDED|95.0|-0.0659|0.1795||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Putamen||0.1795|-0.0659|0.3379
70955563|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.085||||0.2186|TWO_SIDED|95.0|-0.2262|0.0565||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_S1||0.0565|-0.2262|0.2186
70955564|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.008||||0.8191|TWO_SIDED|95.0|-0.0843|0.0678||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Thalamus||0.0678|-0.0843|0.8191
70955565|NCT00760474|141414892|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.012||||0.7647|TWO_SIDED|95.0|-0.0698|0.093||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||Precuneus||0.0930|-0.0698|0.7647
70955566|NCT00515853|141414908|SUPERIORITY|||||||0.54|||||||Regression, Linear|||CCI final||||0.54
70955567|NCT01081132|141414910|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.026|||<|0.001|TWO_SIDED|95.0|-8.865|-3.187|||Mixed Models Repeated Measures Analysis|||||-3.187|-8.865|<0.001
70955568|NCT01081132|141414911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||Cochran-Mantel-Haenszel|||||||0.010
70955569|NCT01081132|141414912|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.115||||0.104|TWO_SIDED|95.0|-0.254|0.024|||Mixed Models Repeated Measures Analysis|||||0.024|-0.254|0.104
70955570|NCT01081132|141414913|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.057||||0.408|TWO_SIDED|95.0|-0.192|0.078|||Mixed Models Repeated Measures Analysis|||||0.078|-0.192|0.408
70955571|NCT01081132|141414914|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.083||||0.176|TWO_SIDED|95.0|-0.203|0.037|||Mixed Models Repeated Measures Analysis|||||0.037|-0.203|0.176
70955572|NCT01081132|141414915|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05||||0.253|TWO_SIDED|95.0|-0.136|-0.036|||Mixed Models Repeated Measures Analysis|||||-0.036|-0.136|0.253
70955573|NCT01081132|141414916|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.004||||0.912|TWO_SIDED|95.0|-0.061|0.068|||Mixed Models Repeated Measures Analysis|||||0.068|-0.061|0.912
70955574|NCT01081132|141414917|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.029||||0.606|TWO_SIDED|95.0|-0.139|0.081|||Mixed Models Repeated Measures Analysis|||||0.081|-0.139|0.606
70955575|NCT01081132|141414918|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.102||||0.228|TWO_SIDED|95.0|-0.064|0.268|||Mixed Models Repeated Measures Analysis|||||0.268|-0.064|0.228
70955576|NCT01081132|141414919|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.047||||0.41|TWO_SIDED|95.0|-0.159|0.065|||Mixed Models Repeated Measures Analysis|||||0.065|-0.159|0.410
70955577|NCT01081132|141414920|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.208||||0.082|TWO_SIDED|95.0|-0.443|0.026|||Mixed Models Repeated Measures Analysis|||||0.026|-0.443|0.082
70955578|NCT01081132|141414921|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70955579|NCT01081132|141414922|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.3||||0.134|TWO_SIDED|95.0|-5.3|0.7|||Mixed Models Repeated Measures Analysis|||Global Executive Composite||0.7|-5.3|0.134
70955580|NCT01081132|141414922|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.579|TWO_SIDED|95.0|-4.0|2.3|||Mixed Models Repeated Measures Analysis|||Behavioral Regulation Index||2.3|-4.0|0.579
70955581|NCT01081132|141414922|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.7||||0.072|TWO_SIDED|95.0|-5.6|0.2|||Mixed Models Repeated Measures Analysis|||Metacognition Index||0.2|-5.6|0.072
70955582|NCT01081132|141414923|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.465|TWO_SIDED|95.0|-1.8|0.8|||Mixed Models Repeated Measures Analysis|||||0.8|-1.8|0.465
70955583|NCT05038163|141414943|SUPERIORITY||Treatment Effect|-0.51|||<|0.001|TWO_SIDED|95.0|-0.63|-0.39|||Regression, Linear|||||-0.39|-0.63|<0.001
70955584|NCT05038163|141414943|SUPERIORITY||Treatment Effect|-0.45|||<|0.001|TWO_SIDED|95.0|-0.57|-0.33|||Regression, Linear|||||-0.33|-0.57|<0.001
70955585|NCT05038163|141414943|SUPERIORITY||Treatment Effect|-0.34|||<|0.001|TWO_SIDED|95.0|-0.44|-0.24|||Regression, Linear|||||-0.24|-0.44|<0.001
70955586|NCT05038163|141414944|SUPERIORITY||Treatment Effect|-0.33||||0.003|TWO_SIDED|95.0|-0.55|-0.11|||Regression, Linear|||||-0.11|-0.55|0.003
70955587|NCT05038163|141414944|SUPERIORITY||Treatment Effect|-0.61|||<|0.001|TWO_SIDED|95.0|-0.87|-0.35|||Regression, Linear|||||-0.35|-0.87|<0.001
70955588|NCT05038163|141414944|SUPERIORITY||Treatment Effect|-0.25|||<|0.001|TWO_SIDED|95.0|-0.48|-0.17|||Regression, Linear|||||-0.17|-0.48|<0.001
70955589|NCT05038163|141414945|SUPERIORITY||Treatment Effect|-0.5|||<|0.001|TWO_SIDED|95.0|-0.67|-0.32|||Regression, Linear||Unit: $ per 12-pack|Gender subgroup: Female or other||-0.32|-0.67|<0.001
70955590|NCT05038163|141414945|SUPERIORITY||Treatment Effect|-0.53|||<|0.001|TWO_SIDED|95.0|-0.7|-0.36|||Regression, Linear||Unit: $ per 12-pack|Gender subgroup: Male||-0.36|-0.70|<0.001
70955591|NCT05038163|141414945|SUPERIORITY||Treatment Effect|-0.41|||<|0.001|TWO_SIDED|95.0|-0.57|-0.25|||Regression, Linear||Unit: $ per 12-pack|Gender subgroup: Female or other||-0.25|-0.57|<0.001
70955592|NCT05038163|141414945|SUPERIORITY||Treatment Effect|-0.48|||<|0.001|TWO_SIDED|95.0|-0.65|-0.32|||Regression, Linear||Unit: $ per 12-pack|Gender subgroup: Male||-0.32|-0.65|<0.001
70955593|NCT05038163|141414945|SUPERIORITY||Treatment Effect|-0.28|||<|0.001|TWO_SIDED|95.0|-0.42|-0.14|||Regression, Linear||Unit: $ per 12-pack|Gender subgroup: Female or other||-0.14|-0.42|<0.001
70955594|NCT05038163|141414945|SUPERIORITY||Treatment Effect|-0.57|||<|0.001|TWO_SIDED|95.0|-0.57|-0.27|||Regression, Linear|||Gender subgroup: Male|Unit: $ per 12-pack|-0.27|-0.57|<0.001
70874612|NCT02310568|141233774|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.36||0.714|TWO_SIDED|90.0|-0.8|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.5|-0.8|0.714
70874613|NCT02310568|141233774|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.35||0.515|TWO_SIDED|90.0|-0.8|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.4|-0.8|0.515
70874614|NCT02310568|141233774|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.34||0.778|TWO_SIDED|90.0|-0.5|0.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.7|-0.5|0.778
70874615|NCT02310568|141233777|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.93||0.562|TWO_SIDED|90.0|-2.1|1.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.0|-2.1|0.562
70874616|NCT02310568|141233777|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.92||0.708|TWO_SIDED|90.0|-1.9|1.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.2|-1.9|0.708
70874617|NCT02310568|141233777|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.05||0.852|TWO_SIDED|90.0|-1.9|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-1.9|0.852
70874618|NCT02310568|141233777|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|1.14||0.347|TWO_SIDED|90.0|-3.0|0.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.8|-3.0|0.347
70874619|NCT02310568|141233777|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.14||0.759|TWO_SIDED|90.0|-2.2|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-2.2|0.759
70874620|NCT02310568|141233777|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.28||0.574|TWO_SIDED|90.0|-2.9|1.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.4|-2.9|0.574
70874621|NCT02310568|141233777|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.09||0.831|TWO_SIDED|90.0|-2.1|1.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.6|-2.1|0.831
70874622|NCT02310568|141233777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.1||0.705|TWO_SIDED|90.0|-1.4|2.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.3|-1.4|0.705
70874623|NCT02310568|141233777|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.24||0.6|TWO_SIDED|90.0|-2.7|1.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.4|-2.7|0.600
70874624|NCT02310568|141233777|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.23||0.848|TWO_SIDED|90.0|-2.3|1.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.8|-2.3|0.848
70874625|NCT02310568|141233777|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.24||0.237|TWO_SIDED|90.0|-0.6|3.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.5|-0.6|0.237
70955595|NCT05038163|141414945|SUPERIORITY||Treatment Effect|-2.23|||<|0.001|TWO_SIDED|95.0|-3.34|-1.12|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: American Indian or Alaska Native||-1.12|-3.34|<0.001
70874626|NCT02310568|141233777|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|1.4||0.224|TWO_SIDED|90.0|-4.0|0.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.6|-4.0|0.224
70874627|NCT02310568|141233777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.38||0.747|TWO_SIDED|90.0|-1.9|2.8|||LS Mean Difference|||(PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.8|-1.9|0.747
70874628|NCT02310568|141233777|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.37||0.764|TWO_SIDED|90.0|-2.8|2.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28). Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.0|-2.8|0.764
70874629|NCT02310568|141233777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.22||0.487|TWO_SIDED|90.0|-1.3|3.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.0|-1.3|0.487
70874630|NCT02310568|141233777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.53||0.744|TWO_SIDED|90.0|-2.1|3.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.2|-2.1|0.744
70874631|NCT02310568|141233777|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.52||0.34|TWO_SIDED|90.0|-1.1|4.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||4.1|-1.1|0.340
70874632|NCT02310568|141233777|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.36||0.477|TWO_SIDED|90.0|-3.3|1.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.4|-3.3|0.477
70874633|NCT02310568|141233777|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.51||0.482|TWO_SIDED|90.0|-1.5|3.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.7|-1.5|0.482
70874634|NCT02310568|141233777|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.49||0.719|TWO_SIDED|90.0|-3.1|2.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.0|-3.1|0.719
70874635|NCT02310568|141233777|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|1.36||0.245|TWO_SIDED|90.0|-0.7|4.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||4.0|-0.7|0.245
70874636|NCT02310568|141233777|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.93||0.586|TWO_SIDED|90.0|-2.3|4.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||4.4|-2.3|0.586
70874637|NCT02310568|141233777|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|1.9||0.44|TWO_SIDED|90.0|-4.8|1.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.8|-4.8|0.440
70874638|NCT02310568|141233777|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.75||0.159|TWO_SIDED|90.0|-0.5|5.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||5.6|-0.5|0.159
70874639|NCT02310568|141233777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.15||0.72|TWO_SIDED|90.0|-1.6|2.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||2.4|-1.6|0.720
70874640|NCT02310568|141233777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.13||0.991|TWO_SIDED|90.0|-2.0|1.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||1.9|-2.0|0.991
70874641|NCT02310568|141233777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.12||0.704|TWO_SIDED|90.0|-1.5|2.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||2.4|-1.5|0.704
71147090|NCT03373240|141787730|SUPERIORITY||Mean Difference (Net)|0.019|STANDARD_ERROR_OF_MEAN|0.096||0.077|TWO_SIDED|97.0|-0.177|0.214|||ANOVA|||||.214|-.177|.077
70874642|NCT02310568|141233778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.82||0.539|TWO_SIDED|90.0|-0.9|1.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.9|-0.9|0.539
70874643|NCT02310568|141233778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.78||0.439|TWO_SIDED|90.0|-0.7|1.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.9|-0.7|0.439
70874644|NCT02310568|141233778|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.92||0.914|TWO_SIDED|90.0|-1.6|1.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.4|-1.6|0.914
70874645|NCT02310568|141233778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.86||0.892|TWO_SIDED|90.0|-1.3|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-1.3|0.892
70874646|NCT02310568|141233778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.82||0.463|TWO_SIDED|90.0|-0.8|2.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.0|-0.8|0.463
70874647|NCT02310568|141233778|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.95||0.611|TWO_SIDED|90.0|-2.1|1.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.1|-2.1|0.611
70874648|NCT02310568|141233778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.88||0.321|TWO_SIDED|90.0|-0.6|2.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.4|-0.6|0.321
70874649|NCT02310568|141233778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.85||0.294|TWO_SIDED|90.0|-0.5|2.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.3|-0.5|0.294
70955596|NCT05038163|141414945|SUPERIORITY||Treatment Effect|-0.69|||<|0.001|TWO_SIDED|95.0|-1.15|-0.23|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Asian||-0.23|-1.15|<0.001
71147091|NCT03373240|141787731|SUPERIORITY||Mean Difference (Net)|-0.964|STANDARD_ERROR_OF_MEAN|1.902||0.547|TWO_SIDED|95.0|-4.822|2.895|||ANOVA|||||2.895|-4.822|.547
70874650|NCT02310568|141233778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.99||0.987|TWO_SIDED|90.0|-1.7|1.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.6|-1.7|0.987
70874651|NCT02310568|141233778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.04||0.599|TWO_SIDED|90.0|-1.2|2.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.3|-1.2|0.599
70874652|NCT02310568|141233778|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.0||0.322|TWO_SIDED|90.0|-0.7|2.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.6|-0.7|0.322
70874653|NCT02310568|141233778|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.17||0.704|TWO_SIDED|90.0|-2.4|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-2.4|0.704
70874654|NCT02310568|141233778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.38||0.804|TWO_SIDED|90.0|-2.0|2.7|||LS Mean Difference|||(PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.7|-2.0|0.804
70874655|NCT02310568|141233778|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.38||0.559|TWO_SIDED|90.0|-3.2|1.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.6|-3.2|0.559
70874656|NCT02310568|141233778|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.27||0.369|TWO_SIDED|90.0|-1.0|3.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.4|-1.0|0.369
71147092|NCT03373240|141787732|SUPERIORITY||Mean Difference (Net)|-0.532|STANDARD_ERROR_OF_MEAN|0.628||0.436|TWO_SIDED|95.0|-1.805|0.742|||ANOVA|||||.742|-1.805|.436
70874657|NCT02310568|141233778|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|1.56||0.313|TWO_SIDED|90.0|-1.1|4.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||4.3|-1.1|0.313
70955597|NCT05038163|141414945|SUPERIORITY||Treatment Effect|0.8|||<|0.001|TWO_SIDED|95.0|0.8|0.8|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Native Hawaiian or Pacific Islander||0.80|0.80|<0.001
70955598|NCT05038163|141414945|SUPERIORITY||Treatment Effect|0.45|||<|0.001|TWO_SIDED|95.0|-0.24|1.14|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Black or African American||1.14|-0.24|<0.001
70955599|NCT05038163|141414945|SUPERIORITY||Treatment Effect|-0.5|||<|0.001|TWO_SIDED|95.0|-0.63|-0.37|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: White||-0.37|-0.63|<0.001
70955600|NCT05038163|141414945|SUPERIORITY||Treatment Effect|-0.96|||<|0.001|TWO_SIDED|95.0|-1.67|-0.25|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: More Than One Race||-0.25|-1.67|<0.001
70955601|NCT05038163|141414945|SUPERIORITY||Treatment Effect|-0.38|||<|0.001|TWO_SIDED|95.0|-1.16|0.4|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Unknown or Not Reported||0.40|-1.16|<0.001
70955602|NCT05038163|141414945|SUPERIORITY||Treatment Effect|-0.44|||<|0.001|TWO_SIDED|95.0|-1.07|0.19|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: American Indian or Alaska Native||0.19|-1.07|<0.001
70955603|NCT05038163|141414945|SUPERIORITY||Treatment Effect|-0.54|||<|0.001|TWO_SIDED|95.0|-0.91|-0.17|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Asian||-0.17|-0.91|<0.001
71147093|NCT05737069|141787737|EQUIVALENCE|The two products were considered to be bioequivalent if 90 percent (%) confidence intervals (CIs) for the geometric mean ratio (GMR) (Test/Reference) for AUC(0-t) were contained within the acceptance interval of 0.8 to 1.25.|Geometric Mean Ratio|1.0008|||||TWO_SIDED|90.0|0.9698|1.0327||||||||1.0327|0.9698|
71147094|NCT05737069|141787738|EQUIVALENCE|The two products were considered to be bioequivalent if 90% CIs for the GMR (Test/Reference) for AUC (0-inf) were contained within the acceptance interval of 0.8 to 1.25.|Geometric Mean Ratio|1.0023|||||TWO_SIDED|90.0|0.971|1.0346||||||||1.0346|0.9710|
70955604|NCT05038163|141414945|SUPERIORITY||Treatment Effect|0.0|||<|0.001|TWO_SIDED|95.0|0.0|0.0|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Native Hawaiian or Pacific Islander||0.00|0.00|<0.001
70955605|NCT05038163|141414945|SUPERIORITY||Treatment Effect|0.16|||<|0.001|TWO_SIDED|95.0|-0.36|0.68|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Black or African American||0.68|-0.36|<0.001
70955606|NCT05038163|141414945|SUPERIORITY||Treatment Effect|-0.44|||<|0.001|TWO_SIDED|95.0|-0.57|-0.31|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: white||-0.31|-0.57|<0.001
70955607|NCT05038163|141414945|SUPERIORITY||Treatment Effect|-1.18|||<|0.001|TWO_SIDED|95.0|-2.04|-0.32|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: More Than One Race||-0.32|-2.04|<0.001
70955608|NCT05038163|141414945|SUPERIORITY||Treatment Effect|-0.38|||<|0.001|TWO_SIDED|95.0|-0.9|0.14|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Unknown or Not Reported||0.14|-0.90|<0.001
70955609|NCT05038163|141414945|SUPERIORITY||Treatment Effect|-0.79|||<|0.001|TWO_SIDED|95.0|-1.54|-0.04|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: American Indian or Alaska Native||-0.04|-1.54|<0.001
70955610|NCT05038163|141414945|SUPERIORITY||Treatment Effect|-0.51|||<|0.001|TWO_SIDED|95.0|-0.9|-0.12|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Asian||-0.12|-0.90|<0.001
71147095|NCT05737069|141787739|EQUIVALENCE|The two products were considered to be bioequivalent if 90% CIs for the GMR (Test/Reference) for Cmax were contained within the acceptance interval of 0.8 to 1.25.|Geometric Mean Ratio|0.9825|||||TWO_SIDED|90.0|0.9383|1.0288||||||||1.0288|0.9383|
70955611|NCT05038163|141414945|SUPERIORITY||Treatment Effect|0.8|||<|0.001|TWO_SIDED|95.0|0.8|0.8|||Regression, Logistic||Unit: $ per 12-pack|Race subgroup: Native Hawaiian or Pacific Islander||0.80|0.80|<0.001
70955612|NCT05038163|141414945|SUPERIORITY||Treatment Effect|-0.04|||<|0.001|TWO_SIDED|95.0|-0.79|0.71|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Black or African American||0.71|-0.79|<0.001
70955613|NCT05038163|141414945|SUPERIORITY||Treatment Effect|-0.33|||<|0.001|TWO_SIDED|95.0|-0.44|-0.22|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: White||-0.22|-0.44|<0.001
70955614|NCT05038163|141414945|SUPERIORITY||Treatment Effect|-0.41|||<|0.001|TWO_SIDED|95.0|-0.76|-0.06|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: More Than One Race||-0.06|-0.76|<0.001
70955615|NCT05038163|141414945|SUPERIORITY||Treatment Effect|-0.27|||<|0.001|TWO_SIDED|95.0|-0.85|0.31|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Unknown or Not Reported||0.31|-0.85|<0.001
70955616|NCT05038163|141414945|SUPERIORITY||Treatment Effect|0.23|||<|0.001|TWO_SIDED|95.0|-0.45|0.91|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Hispanic||0.91|-0.45|<0.001
70955617|NCT05038163|141414945|SUPERIORITY||Treatment Effect|-0.52|||<|0.001|TWO_SIDED|95.0|-0.65|-0.39|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Not Hispanic||-0.39|-0.65|<0.001
71147096|NCT05737069|141787740|EQUIVALENCE|The two products were considered to be bioequivalent if 90% CIs for the GMR (Test/Reference) for AUC(0-t) were contained within the acceptance interval of 0.8 to 1.25.|Geometric Mean Ratio|0.9916|||||TWO_SIDED|90.0|0.9755|1.0081||||||||1.0081|0.9755|
70955618|NCT05038163|141414945|SUPERIORITY||Treatment Effect|-0.93|||<|0.001|TWO_SIDED|95.0|-1.48|-0.38|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Other or Prefer Not to Say||-0.38|-1.48|<0.001
70955619|NCT05038163|141414945|SUPERIORITY||Treatment Effect|-0.16|||<|0.001|TWO_SIDED|95.0|-0.7|0.38|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Hispanic||0.38|-0.70|<0.001
70955620|NCT05038163|141414945|SUPERIORITY||Treatment Effect|-0.45|||<|0.001|TWO_SIDED|95.0|-0.57|-0.33|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Not Hispanic||-0.33|-0.57|<0.001
70955621|NCT05038163|141414945|SUPERIORITY||Treatment Effect|-0.79|||<|0.001|TWO_SIDED|95.0|-1.42|-0.16|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Other or Prefer Not to Say||-0.16|-1.42|<0.001
70955622|NCT05038163|141414945|SUPERIORITY||Treatment Effect|0.01||||0.98|TWO_SIDED|95.0|-0.4|0.41|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Hispanic||0.41|-0.40|0.980
70955623|NCT05038163|141414945|SUPERIORITY||Treatment Effect|-0.36|||<|0.001|TWO_SIDED|95.0|-0.47|-0.25|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Not Hispanic||-0.25|-0.47|<0.001
70955624|NCT05038163|141414945|SUPERIORITY||Treatment Effect|-0.39|||<|0.001|TWO_SIDED|95.0|-1.03|0.25|||Regression, Linear||Unit: $ per 12-pack|Ethnicity Subgroup: Other or Prefer Not to Say||0.25|-1.03|<0.001
70955625|NCT00383110|141414951|SUPERIORITY_OR_OTHER|||||||0.648|||||||ANOVA|||||||0.648
70955626|NCT00383110|141414952|SUPERIORITY_OR_OTHER|||||||0.14|||||||ANOVA|||||||0.14
70955627|NCT00383110|141414953|SUPERIORITY_OR_OTHER|||||||0.675|||||||ANOVA|||||||0.675
70955628|NCT00383110|141414954|SUPERIORITY_OR_OTHER|||||||0.03|||||||ANOVA|||||||0.03
70955629|NCT00383110|141414955|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
70955630|NCT00383110|141414956|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
70874658|NCT02310568|141233778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.56||0.56|TWO_SIDED|90.0|-1.8|3.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.6|-1.8|0.560
70874659|NCT02310568|141233778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.43||0.635|TWO_SIDED|90.0|-1.8|3.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.2|-1.8|0.635
70874660|NCT02310568|141233778|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.62||0.538|TWO_SIDED|90.0|-1.8|3.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.8|-1.8|0.538
70874661|NCT02310568|141233778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.6||0.942|TWO_SIDED|90.0|-2.7|2.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.9|-2.7|0.942
70874662|NCT02310568|141233778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.5||0.555|TWO_SIDED|90.0|-1.7|3.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.5|-1.7|0.555
70874663|NCT02310568|141233778|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.96||0.728|TWO_SIDED|90.0|-4.1|2.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.7|-4.1|0.728
71147097|NCT05737069|141787741|EQUIVALENCE|The two products were considered to be bioequivalent if 90% CIs for the GMR (Test/Reference) for AUC (0-inf) were contained within the acceptance interval of 0.8 to 1.25.|Geometric Mean Ratio|0.9776|||||TWO_SIDED|90.0|0.9432|1.0133||||||||1.0133|0.9432|
71147098|NCT05737069|141787742|EQUIVALENCE|The two products were considered to be bioequivalent if 90% CIs for the GMR (Test/Reference) for Cmax were contained within the interval of 0.8 to 1.25.|Geometric Mean Ratio|0.9982|||||TWO_SIDED|90.0|0.9431|1.0567||||||||1.0567|0.9431|
71147099|NCT04050553|141787754|SUPERIORITY||Least Square (LS) Mean Difference|-0.49||||0.7556|TWO_SIDED|95.0|-3.64|2.67|||Mixed Models Analysis|||||2.67|-3.64|0.7556
71147100|NCT04050553|141787755|SUPERIORITY||LS Mean Difference|-174.77||||0.0043|TWO_SIDED|95.0|-290.34|-59.21|||Mixed Models Analysis|||||-59.21|-290.34|0.0043
71147101|NCT04050553|141787756|SUPERIORITY||LS Mean Difference|-488.31|||<|0.0001|TWO_SIDED|95.0|-621.25|-355.36|||Mixed Models Analysis|||||-355.36|-621.25|<0.0001
71147102|NCT04050553|141787757|SUPERIORITY||LS Mean Difference|4.39||||0.0023|TWO_SIDED|95.0|1.69|7.08|||Mixed Models Analysis|||||7.08|1.69|0.0023
70874664|NCT02310568|141233778|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|1.95||0.362|TWO_SIDED|90.0|-5.2|1.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.6|-5.2|0.362
71147103|NCT04050553|141787758|SUPERIORITY||LS Mean Difference|-0.06||||0.0505|TWO_SIDED|95.0|-0.13|0.0|||Mixed Models Analysis|||For Overall Hypoglycemia Symptom Score at concentration of 100 mg/dL.||0.00|-0.13|0.0505
71147104|NCT04050553|141787758|SUPERIORITY||LS Mean Difference|-0.18||||0.0104|TWO_SIDED|95.0|-0.31|-0.05|||Mixed Models Analysis|||For Overall Hypoglycemia Symptom Score at concentration of 63 mg/dL.||-0.05|-0.31|0.0104
70874665|NCT02310568|141233778|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.81||0.538|TWO_SIDED|90.0|-2.0|4.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||4.3|-2.0|0.538
70874666|NCT02310568|141233778|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.11||0.949|TWO_SIDED|90.0|-2.0|1.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||1.8|-2.0|0.949
70874667|NCT02310568|141233778|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.09||0.708|TWO_SIDED|90.0|-2.3|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||1.5|-2.3|0.708
70955631|NCT03762200|141414957|OTHER|Confidence Interval|percentage of sucesses|87.4|||||TWO_SIDED|95.0|79.4|93.1||||||||93.1|79.4|
71147105|NCT04050553|141787758|SUPERIORITY||LS Mean Difference|-0.19||||0.0068|TWO_SIDED|95.0|-0.32|-0.06|||Mixed Models Analysis|||For Overall Hypoglycemia Symptom Score at concentration of 45 mg/dL.||-0.06|-0.32|0.0068
70874668|NCT02310568|141233778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.07||0.752|TWO_SIDED|90.0|-1.5|2.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||2.2|-1.5|0.752
70955632|NCT03762200|141414958|OTHER|Confidence Interval|Percentage of Successes|77.7|||||TWO_SIDED|95.0|68.4|85.3||||||||85.3|68.4|
70955633|NCT03762200|141414959|OTHER|Confidence Interval|Percentage of Successes|92.2|||||TWO_SIDED|95.0|85.3|96.6||||||||96.6|85.3|
71147106|NCT04050553|141787758|SUPERIORITY||LS Mean Difference|-0.11||||0.2302|TWO_SIDED|95.0|-0.3|0.08|||Mixed Models Analysis|||For Overall Hypoglycemia Symptom Score at concentration of 72 mg/dL.||0.08|-0.30|0.2302
71147107|NCT04050553|141787759|SUPERIORITY||LS Mean Difference|-0.51||||0.8298|TWO_SIDED|95.0|-5.28|4.27|||Mixed Models Analysis|||For systolic blood pressure.||4.27|-5.28|0.8298
71147108|NCT04050553|141787759|SUPERIORITY||LS Mean Difference|1.96||||0.1516|TWO_SIDED|95.0|-0.76|4.67|||Mixed Models Analysis|||For diastolic blood pressure.||4.67|-0.76|0.1516
70874669|NCT02310568|141233779|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|90.0|0.37|2.45|||Regression, Logistic|||(PF-06372865 7.5 mg - Placebo). Logistic regression model includes treatment as fixed effect, and baseline as covariate. Baseline for Stage 1 is Day 1 and Stage 2 is Week 4 (Day 28).||2.45|0.37|
71147109|NCT04050553|141787760|SUPERIORITY||LS Mean Difference|-0.89||||0.5776|TWO_SIDED|95.0|-4.1|2.33|||Mixed Models Analysis|||||2.33|-4.10|0.5776
71147110|NCT02201953|141787771|NON_INFERIORITY_OR_EQUIVALENCE|Primary analyses consisted of non-inferiority test of Group 1 (SOF/VEL 12 weeks) versus Group 2 (SOF+RBV 24 weeks) at the 0.05 significance level. Non-inferiority was assessed using the conventional confidence interval approach and a non-inferiority margin of 10% was applied. The two-sided 95% confidence intervals was constructed using stratum-adjusted Mantel-Haenszel proportions, stratified by the randomization stratification factors (i.e cirrhosis status and prior treatment experience)|Difference in proportions|14.4|||||TWO_SIDED|95.0|9.2|19.6|||||Difference in proportions between treatment groups and associated 95% confidence intervals (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions.|||19.6|9.2|
71147111|NCT02201953|141787771|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value was from the Cochran-Mantel-Haenszel test stratified by cirrhosis status and prior HCV treatment experience.|Cochran-Mantel-Haenszel|||If the lower bound of 95% CI on the difference was \> -10%, the p-value tested for the superiority of SOF/VEL for 12 weeks over SOF+RBV for 24 weeks. Superiority was demonstrated if the two-sided p-value is less than 0.05.||||<0.001
71147112|NCT02153632|141787783|SUPERIORITY||Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|1.75||0.031|TWO_SIDED|95.0|-10.5|-0.5|||ANCOVA|||||-0.5|-10.5|0.031
71147113|NCT02153632|141787783|SUPERIORITY||Mean Difference (Final Values)|-6.5|STANDARD_ERROR_OF_MEAN|1.71||0.011|TWO_SIDED|95.0|-11.5|-1.5|||ANCOVA|||||-1.5|-11.5|0.011
71147114|NCT02892344|141787818|SUPERIORITY||Mean Difference (Net)|0.182|||<|0.001|TWO_SIDED|95.0|0.148|0.217|||Mixed Models Analysis|||||0.217|0.148|<0.001
71147115|NCT02892344|141787819|SUPERIORITY||Mean Difference (Net)|-0.218|||<|0.001|TWO_SIDED|95.0|-0.293|-0.143|||Mixed Models Analysis|||||-0.143|-0.293|<0.001
71147116|NCT02892344|141787820|SUPERIORITY||Mean Difference (Net)|0.132|||<|0.001|TWO_SIDED|95.0|0.105|0.158|||Mixed Models Analysis|||||0.158|0.105|<0.001
71147117|NCT02892344|141787821|SUPERIORITY||Mean Difference (Net)|0.176|||<|0.001|TWO_SIDED|95.0|0.145|0.207|||Mixed Models Analysis|||||0.207|0.145|<0.001
71147118|NCT02892344|141787822|SUPERIORITY||Mean Difference (Net)|0.1|||<|0.001|TWO_SIDED|95.0|0.061|0.139|||Mixed Models Analysis|||Pre-dose trough FVC||0.139|0.061|<0.001
71147119|NCT02892344|141787822|SUPERIORITY||Mean Difference (Net)|0.288|||<|0.001|TWO_SIDED|95.0|0.231|0.345|||Mixed Models Analysis|||Pre-dose trough FEF25-75%||0.345|0.231|<0.001
71147120|NCT02892344|141787823|SUPERIORITY||Mean Difference (Net)|27.2|||<|0.001|TWO_SIDED|95.0|22.1|32.4|||Mixed Models Analysis|||Mean Morning PEF||32.4|22.1|<0.001
71147121|NCT02892344|141787823|SUPERIORITY||Mean Difference (Net)|26.1|||<|0.001|TWO_SIDED|95.0|21.0|31.2|||Mixed Models Analysis|||Mean Evening PEF||31.2|21.0|<0.001
71147122|NCT02892344|141787826|SUPERIORITY||Mean Difference (Net)|-0.204|||<|0.001|TWO_SIDED|95.0|-0.277|-0.131|||Mixed Models Analysis|||||-0.131|-0.277|<0.001
71147123|NCT02892344|141787827|SUPERIORITY||Mean Difference (Net)|-0.11|||<|0.001|TWO_SIDED|95.0|-0.16|-0.05|||Mixed Models Analysis|||Night-time number of puffs of rescue medication||-0.05|-0.16|<0.001
71147124|NCT02892344|141787827|SUPERIORITY||Mean Difference (Net)|-0.15|||<|0.001|TWO_SIDED|95.0|-0.22|-0.08|||Mixed Models Analysis|||Daytime number of puffs of rescue medication||-0.08|-0.22|<0.001
71147125|NCT02892344|141787828|SUPERIORITY||Mean Difference (Net)|8.1|||<|0.001|TWO_SIDED|95.0|4.3|11.8|||Mixed Models Analysis|||||11.8|4.3|<0.001
70874670|NCT02310568|141233779|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64|||||TWO_SIDED|90.0|0.39|6.88|||Regression, Logistic|||(PF-06372865 2.5 mg - Placebo). Logistic regression model includes treatment as fixed effect, and baseline as covariate. Baseline for Stage 1 is Day 1 and Stage 2 is Week 4 (Day 28).||6.88|0.39|
71147126|NCT02892344|141787829|SUPERIORITY||Mean Difference (Net)|0.149|||<|0.001|TWO_SIDED|95.0|0.064|0.234|||Mixed Models Analysis|||||0.234|0.064|<0.001
71147127|NCT02892344|141787832|SUPERIORITY||Hazard Ratio (HR)|0.29|||<|0.001|TWO_SIDED|95.0|0.14|0.59|||Regression, Cox|||||0.59|0.14|<0.001
71147128|NCT01084655|141787886|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Square(LS)Means|1.204|||||TWO_SIDED|90.0|0.87|1.666||||||ANOVA with dose level as a fixed effect and participant as a random effect.||1.666|0.870|
71147129|NCT01084655|141787887|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.074|||||TWO_SIDED|90.0|0.793|1.455||||||ANOVA with dose level as a fixed effect and participant as a random effect.||1.455|0.793|
71147130|NCT01084655|141787890|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.066|||||TWO_SIDED|90.0|0.802|1.417||||||ANOVA with dose level as a fixed effect and participant as a random effect.||1.417|0.802|
71147131|NCT01084655|141787891|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.068|||||TWO_SIDED|90.0|0.955|1.195||||||ANOVA with dose level as a fixed effect and participant as a random effect.||1.195|0.955|
71147132|NCT01074814|141787906|OTHER||||||||||||||||||Results for the primary objective - evaluation of GMI - were presented with descriptive statistics as the ration of PFS on current therapy over the PFS on latest therapy. The percentage of patients with GMI greater than 1.3 was displayed along with its corresponding 95% exact confidence interval.|||
71147133|NCT05024032|141787913|SUPERIORITY||LS Mean Difference|-12.0|||<|0.001|TWO_SIDED|95.0|-14.8|-9.3|||Mixed Models Analysis|||||-9.3|-14.8|<0.001
71147134|NCT05024032|141787913|SUPERIORITY||LS Mean Difference|-17.5|||<|0.001|TWO_SIDED|95.0|-20.3|-14.8|||Mixed Models Analysis|||||-14.8|-20.3|<0.001
70874671|NCT02310568|141233779|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58|||||TWO_SIDED|90.0|0.23|1.49|||Regression, Logistic|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Logistic regression model includes treatment as fixed effect, and baseline as covariate. Baseline for Stage 1 is Day 1 and Stage 2 is Week 4 (Day 28).||1.49|0.23|
71147135|NCT05024032|141787914|SUPERIORITY||Odds Ratio (OR)|23.11|||<|0.001|TWO_SIDED|95.0|8.8|60.69|||Regression, Logistic|||||60.69|8.80|<0.001
70874672|NCT01635101|141233788|OTHER||LS Mean Difference|-11.8||||0.736|TWO_SIDED|97.5|-91.0|67.3|||ANOVA|||Difference in Least Squares (LS) Means||67.3|-91.0|0.736
70874673|NCT01635101|141233788|OTHER||LS Mean Difference|1.4||||0.967|TWO_SIDED|97.5|-75.9|78.7|||ANOVA|||LS Mean Difference||78.7|-75.9|0.967
70874674|NCT03232801|141233798|SUPERIORITY||chi-squared|4.86||||0.027|TWO_SIDED||||||Chi-squared|||||||0.027
70874675|NCT03232801|141233799|SUPERIORITY||chi-squared|0.45||||0.503|TWO_SIDED||||||Chi-squared|||||||0.503
70874676|NCT02289690|141233856|OTHER||RP2D for veliparib in mg BID for 14 days|240.0|||||TWO_SIDED||||||||The RP2D for veliparib was determined to be 240 mg BID for 14 days with carboplatin (AUC 5 mg/mL\*min) on Day 1 and etoposide (100 mg/m²) on Days 1 to 3 during 21-day cycles for 4 cycles.|A primary objective of Phase 1 was to establish the recommended phase 2 dose (RP2D) for veliparib combined with carboplatin and etoposide. The RP2D was determined by the rate of DLTs and overall tolerability of veliparib plus carboplatin and etoposide.||||
70874677|NCT02289690|141233872|SUPERIORITY||Hazard Ratio (HR)|0.665||||0.059|TWO_SIDED|80.0|0.503|0.88|||Log Rank|Two-sided log-rank test stratified by lactate dehydrogenase (LDH) level|Hazard ratio estimate was obtained from a Cox proportional hazards model stratified by LDH level. A hazard ratio \< 1 favors veliparib in combination with carboplatin and etoposide followed by veliparib maintenance monotherapy (Arm A).|"The primary efficacy analysis in the Phase 2 portion of the study was the comparison of PFS among participants who received veliparib in combination with carboplatin and etoposide followed by veliparib maintenance monotherapy (Arm A) vs. placebo in combination with carboplatin and etoposide followed by placebo maintenance monotherapy (Arm C).~Statistical significance was determined by a two-sided p-value ≤ 0.2"||0.880|0.503|0.059
70874678|NCT02289690|141233872|SUPERIORITY||Hazard Ratio (HR)|0.979||||0.924|TWO_SIDED|80.0|0.744|1.288|||Log Rank|Two-sided log-rank test stratified by lactate dehydrogenase (LDH) level|Hazard ratio estimate was obtained from a Cox proportional hazards model stratified by LDH level. A hazard ratio of \< 1 favors veliparib in combination with carboplatin and etoposide followed by placebo maintenance monotherapy (Arm B).|"If the primary analysis of PFS (Arm A vs Arm C) was statistically significant a fixed sequence testing procedure was to be performed with a 2-sided significance level of 0.2 for the following key secondary endpoints:~1. OS (Arm A vs Arm C)~2. PFS (Arms B vs Arm C)~3. OS (Arm B vs Arm C)~4. ORR (Arm A vs Arm C)~5. ORR (Arm B vs Arm C)~If significance versus Arm C was not demonstrated, all endpoints later in the testing hierarchy were to be considered exploratory."||1.288|0.744|0.924
71147136|NCT05024032|141787914|SUPERIORITY||Odds Ratio (OR)|26.53|||<|0.001|TWO_SIDED|95.0|9.61|73.24|||Regression, Logistic|||||73.24|9.61|<0.001
71147137|NCT05024032|141787915|SUPERIORITY||LS Mean Difference|-7.2|||<|0.001|TWO_SIDED|95.0|-8.8|-5.5|||Mixed Models Analysis|||||-5.5|-8.8|<0.001
70874679|NCT02289690|141233873|SUPERIORITY||Hazard Ratio (HR)|1.432||||0.088|TWO_SIDED|80.0|1.092|1.879|||Log Rank|Two-sided log rank test stratified by LDH level.|Hazard ratio estimate was obtained from a Cox proportional hazards model stratified by LDH level. A hazard ratio of \< 1 favors veliparib in combination with carboplatin and etoposide followed by veliparib maintenance monotherapy (Arm A).|"If the primary analysis of PFS (Arm A vs Arm C) was statistically significant a fixed sequence testing procedure was to be performed with a 2-sided significance level of 0.2 for the following key secondary endpoints:~1. OS (Arm A vs Arm C)~2. PFS (Arms B vs Arm C)~3. OS (Arm B vs Arm C)~4. ORR (Arm A vs Arm C)~5. ORR (Arm B vs Arm C)~If significance versus Arm C was not demonstrated, all endpoints later in the testing hierarchy were to be considered exploratory."||1.879|1.092|0.088
70874680|NCT02289690|141233873|SUPERIORITY||Hazard Ratio (HR)|1.46||||0.083|TWO_SIDED|80.0|1.104|1.931|||Log Rank|Two-sided log rank test stratified by LDH level.|Hazard ratio estimate was obtained from a Cox proportional hazards model stratified by LDH level. A hazard ratio of \< 1 favors veliparib in combination with carboplatin and etoposide followed by placebo maintenance monotherapy (Arm B).|"If the primary analysis of PFS (Arm A vs Arm C) was statistically significant a fixed sequence testing procedure was to be performed with a 2-sided significance level of 0.2 for the following key secondary endpoints:~1. OS (Arm A vs Arm C)~2. PFS (Arms B vs Arm C)~3. OS (Arm B vs Arm C)~4. ORR (Arm A vs Arm C)~5. ORR (Arm B vs Arm C)~If significance versus Arm C was not demonstrated, all endpoints later in the testing hierarchy were to be considered exploratory."||1.931|1.104|0.083
70874681|NCT02289690|141233874|SUPERIORITY||Odds Ratio (OR)|1.9||||0.115|TWO_SIDED|80.0|1.1|3.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by LDH level.|Odds ratio was from a Cochran-Mantel-Haenszel test stratified by LDH level. An odds ratio of \> 1 favors veliparib in combination with carboplatin and etoposide followed by veliparib maintenance monotherapy (Arm A).|"If the primary analysis of PFS (Arm A vs Arm C) was statistically significant a fixed sequence testing procedure was to be performed with a 2-sided significance level of 0.2 for the following key secondary endpoints:~1. OS (Arm A vs Arm C)~2. PFS (Arms B vs Arm C)~3. OS (Arm B vs Arm C)~4. ORR (Arm A vs Arm C)~5. ORR (Arm B vs Arm C)~If significance versus Arm C was not demonstrated, all endpoints later in the testing hierarchy were to be considered exploratory."||3.2|1.1|0.115
71147138|NCT05024032|141787915|SUPERIORITY||LS Mean Difference|-9.2|||<|0.001|TWO_SIDED|95.0|-10.9|-7.5|||Mixed Models Analysis|||||-7.5|-10.9|<0.001
71147139|NCT05024032|141787916|SUPERIORITY||Odds Ratio (OR)|13.19|||<|0.001|TWO_SIDED|95.0|5.63|30.89|||Regression, Logistic|||||30.89|5.63|<0.001
71147140|NCT05024032|141787916|SUPERIORITY||Odds Ratio (OR)|28.58|||<|0.001|TWO_SIDED|95.0|11.23|72.71|||Regression, Logistic|||||72.71|11.23|<0.001
70874682|NCT02289690|141233874|SUPERIORITY||Odds Ratio (OR)|0.8||||0.604|TWO_SIDED|80.0|0.5|1.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by LDH level.|Odds ratio was from a Cochran-Mantel-Haenszel test stratified by LDH level. An odds ratio of \> 1 favors veliparib in combination with carboplatin and etoposide followed by placebo maintenance monotherapy (Arm B).|"If the primary analysis of PFS (Arm A vs Arm C) was statistically significant a fixed sequence testing procedure was to be performed with a 2-sided significance level of 0.2 for the following key secondary endpoints:~1. OS (Arm A vs Arm C)~2. PFS (Arms B vs Arm C)~3. OS (Arm B vs Arm C)~4. ORR (Arm A vs Arm C)~5. ORR (Arm B vs Arm C)~If significance versus Arm C was not demonstrated, all endpoints later in the testing hierarchy were to be considered exploratory."||1.3|0.5|0.604
71147141|NCT05024032|141787917|SUPERIORITY||Odds Ratio (OR)|25.64|||<|0.001|TWO_SIDED|95.0|6.68|98.49|||Regression, Logistic|||||98.49|6.68|<0.001
71147142|NCT05024032|141787917|SUPERIORITY||Odds Ratio (OR)|69.79|||<|0.001|TWO_SIDED|95.0|17.69|275.37|||Regression, Logistic|||||275.37|17.69|<0.001
71147143|NCT05024032|141787918|SUPERIORITY||LS Mean Difference|-9.2|||<|0.001|TWO_SIDED|95.0|-11.5|-6.9|||Mixed Models Analysis|||||-6.9|-11.5|<0.001
71147144|NCT05024032|141787918|SUPERIORITY||LS Mean Difference|-13.7|||<|0.001|TWO_SIDED|95.0|-16.0|-11.3|||Mixed Models Analysis|||||-11.3|-16.0|<0.001
71147145|NCT05024032|141787919|SUPERIORITY||LS Mean Difference|-10.9|||<|0.001|TWO_SIDED|95.0|-13.5|-8.3|||Mixed Models Analysis|||||-8.3|-13.5|<0.001
71147146|NCT05024032|141787919|SUPERIORITY||LS Mean Difference|-16.0|||<|0.001|TWO_SIDED|95.0|-18.6|-13.4|||Mixed Models Analysis|||||-13.4|-18.6|<0.001
71147147|NCT05024032|141787920|SUPERIORITY||LS Mean Difference|-3.9|||<|0.001|TWO_SIDED|95.0|-4.8|-3.1|||Mixed Models Analysis|||||-3.1|-4.8|<0.001
71147148|NCT05024032|141787920|SUPERIORITY||LS Mean Difference|-5.6|||<|0.001|TWO_SIDED|95.0|-6.4|-4.8|||Mixed Models Analysis|||||-4.8|-6.4|<0.001
71147149|NCT05024032|141787921|SUPERIORITY||LS Mean Difference|-0.37|||<|0.001|TWO_SIDED|95.0|-0.46|-0.28|||Mixed Models Analysis|||||-0.28|-0.46|<0.001
71147150|NCT05024032|141787921|OTHER||LS Mean Difference|-0.39|||<|0.001|TWO_SIDED|95.0|-0.48|-0.29|||Mixed Models Analysis|||||-0.29|-0.48|<0.001
70955634|NCT03973931|141414991|NON_INFERIORITY|Generalized Estimating Equation (GEE) model with an identity link and independence with unequal variances for the covariance structure of the 12 observations|||||<|0.05|||||||GEE|To account for multiple treatment comparisons significance levels of 0.05/3||||||<0.05
71147151|NCT05024032|141787922|SUPERIORITY||LS Mean Difference|-0.46|||<|0.001|TWO_SIDED|95.0|-0.61|-0.32|||Mixed Models Analysis|||||-0.32|-0.61|<0.001
71147152|NCT05024032|141787922|SUPERIORITY||LS Mean Difference|-0.54|||<|0.001|TWO_SIDED|95.0|-0.69|-0.4|||Mixed Models Analysis|||||-0.40|-0.69|<0.001
71147153|NCT05024032|141787923|SUPERIORITY||LS Mean Difference|1.2||||0.044|TWO_SIDED|95.0|0.0|2.3|||ANCOVA|||||2.3|0.0|0.044
71147154|NCT05024032|141787923|SUPERIORITY||LS Mean Difference|1.2||||0.05|TWO_SIDED|95.0|0.0|2.3|||ANCOVA|||||2.3|0.0|0.050
71147155|NCT05024032|141787924|SUPERIORITY||LS Mean Difference|7.8|||<|0.001|TWO_SIDED|95.0|3.7|11.8|||ANCOVA|||||11.8|3.7|<0.001
71147156|NCT05024032|141787924|SUPERIORITY||LS Mean Difference|8.5|||<|0.001|TWO_SIDED|95.0|4.4|12.7|||ANCOVA|||||12.7|4.4|<0.001
71147157|NCT05024032|141787925|SUPERIORITY||LS Mean Difference|-4.8|||<|0.001|TWO_SIDED|95.0|-6.9|-2.7|||Mixed Models Analysis|||||-2.7|-6.9|<0.001
71147158|NCT05024032|141787926|SUPERIORITY||LS Mean Difference|-6.1|||<|0.001|TWO_SIDED|95.0|-9.1|-3.1|||Mixed Models Analysis|||||-3.1|-9.1|<0.001
71147159|NCT05024032|141787927|SUPERIORITY||LS Mean Difference|-0.31|||||TWO_SIDED|95.0|-0.51|-0.11||||||||-0.11|-0.51|
71147160|NCT05024032|141787928|SUPERIORITY||LS Mean Difference|0.09|||||TWO_SIDED|95.0|0.03|0.14||||||||0.14|0.03|
71147161|NCT05024032|141787929|SUPERIORITY||LS Mean Difference|-0.06|||||TWO_SIDED|95.0|-0.25|0.13||||||||0.13|-0.25|
71147162|NCT05024032|141787930|SUPERIORITY||LS Mean Difference|-0.25|||||TWO_SIDED|95.0|-0.34|-0.16||||||||-0.16|-0.34|
71147163|NCT05024032|141787931|SUPERIORITY||LS Mean Difference|-0.58|||||TWO_SIDED|95.0|-0.79|-0.37||||||||-0.37|-0.79|
71147164|NCT05024032|141787932|SUPERIORITY||LS Mean Difference|-0.07|||||TWO_SIDED|95.0|-0.12|-0.01||||||||-0.01|-0.12|
71147165|NCT05024032|141787933|SUPERIORITY||LS Mean Difference|-6.3|||||TWO_SIDED|95.0|-8.6|-4.0||||||||-4.0|-8.6|
71147166|NCT03591406|141787942|NON_INFERIORITY|Pre-defined non-inferiority margin of -15%|Difference in proportions|1.12|||||TWO_SIDED|95.0|-2.15|4.71|||||2-sided 95% Confidence Interval (CI) was computed using the Wilson score method with continuity correction described by Newcombe.|||4.71|-2.15|
71147167|NCT02066181|141787956|SUPERIORITY||Hazard Ratio (HR)|11.3|||<|0.001|ONE_SIDED|95.0|5.7||||Log Rank||||||5.7|<0.001
71147168|NCT02851615|141787990|SUPERIORITY|Power analyses were calculated on the PAM-13, our primary outcome measure. Analyses were conducted using the internal Monte Carlo simulation capabilities of Mplus (Version 1.20). Based on the effect size obtained from published pilot data, we expected the change in baseline/posttreatment Behavioral Activation for the SCThrive intervention group to be n2 = .14 (large effect). Based on these assumptions, the desired sample size was 54 participants (N = 27 per group) to achieve power of .80.|Mean Difference (Net)|7.75|STANDARD_ERROR_OF_MEAN|13.14||0.09|TWO_SIDED|95.0|-1.27|19.22||The threshold for statistical significance was p =.05|ANCOVA|||We conducted separate mixed ANOVA analyses to assess for the effects of group (SCThrive/SCHealthEd), time (baseline/post-treatment), and group x time interaction for the PAM-13.||19.22|-1.27|.09
71147169|NCT02851615|141787991|SUPERIORITY||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.55||0.28|TWO_SIDED|95.0|-0.19|0.66||The threshold for significance was p =.05|ANCOVA|||We conducted separate mixed ANOVA analyses to assess for the effects of group (SCThrive/SCHealthEd), time (baseline/post-treatment), and group x time interaction for the TRAQ-5||.66|-.19|.28
71147170|NCT02851615|141787992|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_DEVIATION|0.13||0.27|TWO_SIDED|95.0|-0.018|0.06||The threshold for statistical significance was p =.05|t-test, 2 sided|||We conducted a paired-samples t-test to assess for the effects of time (baseline/post-treatment) for participants (n=16) in the SCThrive intervention arm for the UNC TRxANSITION Scale.||.06|-.018|.27
70874683|NCT01170754|141233876|NON_INFERIORITY|Inferiority between the two groups was defined as a difference of 10% in the overall BBPS score||||||0.45|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.45
70874684|NCT01170754|141233877|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.13|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.13
70874685|NCT01170754|141233878|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.31|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.31
70874686|NCT01170754|141233879|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.87|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.87
70874687|NCT01170754|141233880|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.25|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.25
71147171|NCT05764785|141787994|SUPERIORITY|||||||0.182||||||Assumption of Sphericity was violated and Greenhouse-Geisser was above .75, thus Huynh-Feldt correction was used.|Mixed ANOVA|||||||.182
70874688|NCT01170754|141233881|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.47|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.47
70874689|NCT01170754|141233882|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.34|TWO_SIDED|95.0|||||t-test, 2 sided|||||||.34
70874690|NCT01170754|141233883|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.18|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.18
70874691|NCT01170754|141233884|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.75|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.75
70874692|NCT01170754|141233885|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.92|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.92
70874693|NCT01170754|141233886|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.6|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.60
71147172|NCT05764785|141787995|SUPERIORITY|||||||0.461||||||Assumption of Sphericity was violated and Greenhouse-Geisser was above .75, thus Huynh-Feldt correction was used.|Mixed ANOVA|||||||.461
71147173|NCT05764785|141787996|SUPERIORITY|||||||0.228||||||Assumption of Sphericity was violated and Greenhouse-Geisser was above .75, thus Huynh-Feldt correction was used.|Mixed ANOVA|||||||.228
71147174|NCT05764785|141787997|SUPERIORITY|||||||0.295||||||Assumption of Sphericity was violated and Greenhouse-Geisser was above .75, thus Huynh-Feldt correction was used.|Mixed ANOVA|||||||.295
71147175|NCT05764785|141787998|SUPERIORITY|||||||0.915||||||Assumption of Sphericity was violated and Greenhouse-Geisser was above .75, thus Huynh-Feldt correction was used.|Mixed ANOVA|||||||.915
71147176|NCT05764785|141787999|SUPERIORITY|||||||0.226||||||Assumption of Sphericity was violated and Greenhouse-Geisser was above .75, thus Huynh-Feldt correction was used.|Mixed ANOVA|||||||.226
71147177|NCT02670811|141788010|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The primary outcome, systolic blood pressure (mmHg), between groups was analyzed using an independent sample student t test.|t-test, 2 sided|||||||<0.05
71147178|NCT02670811|141788010|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The primary outcome, systolic blood pressure (mmHg), was analyzed using a paired student t test.|t-test, 2 sided|||||||<0.05
71147179|NCT02670811|141788011|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The secondary outcome, diastolic blood pressure (mmHg), between groups was analyzed using an independent sample student t test.|t-test, 2 sided|||||||<0.05
71147180|NCT02670811|141788012|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The secondary outcome, total cholesterol (mg/dL), between groups was analyzed using an independent sample student t test.|t-test, 2 sided|||||||<0.05
71147181|NCT02670811|141788013|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The secondary outcome, low density lipoprotein (mg/dL), between groups was analyzed using an independent sample student t test.|t-test, 2 sided|||||||<0.05
71147182|NCT02670811|141788014|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The secondary outcome, high density lipoproteins (mg/dL), between groups were analyzed using an independent sample student t test.|t-test, 2 sided|||||||<0.05
70874694|NCT01170754|141233887|NON_INFERIORITY|Inferiority between groups was defined as a difference of 10% in the overall BBPS score.||||||0.98|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance.|t-test, 2 sided|||||||.98
70874695|NCT01391559|141233896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.0||||0.17||95.0|||||t-test, 2 sided|||||||0.17
70874696|NCT01442493|141233905|SUPERIORITY|||||||0.92|||||||Mixed Models Analysis|||||||0.92
70874697|NCT01442493|141233906|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|||||||0.06
70874698|NCT01442493|141233907|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||0.08
70874699|NCT01442493|141233908|SUPERIORITY|||||||0.54|||||||Mixed Models Analysis|||||||0.54
70874700|NCT01442493|141233909|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||.04
70874701|NCT01442493|141233910|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||||||0.11
70874702|NCT01442493|141233911|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||||||0.21
70874703|NCT01111149|141233921|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for Serum Cotinine at Week 12||||>0.05
70874704|NCT01111149|141233921|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for Serum Nicotine at Week 12||||>0.05
70874705|NCT01111149|141233921|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for Urine Cotinine at Week 12||||>0.05
71147183|NCT02670811|141788015|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The secondary outcome, triglycerides (mg/dL), between groups was analyzed using an independent sample student t test.|t-test, 2 sided|||||||<0.05
71147184|NCT03714672|141788036|SUPERIORITY||Mean Difference (Final Values)|-4.1|||<|0.0001|TWO_SIDED|95.0|-4.8|-3.4|||ANCOVA|ANCOVA model with treatment, baseline pain intensity, and site as covariates.|LS means, 95% CIs, and pairwise CIs and p-values comparing the combination treatment arm to the monotherapy arm.|Bonferroni-Holm procedure used for determining the statistical significance of the results.||-3.4|-4.8|<0.0001
71147185|NCT03714672|141788036|SUPERIORITY||Mean Difference (Final Values)|-4.5|||<|0.0001|TWO_SIDED|95.0|-5.2|-3.8|||ANCOVA|ANCOVA model with treatment, baseline pain intensity, and site as covariates.|LS means, 95% CIs, and pairwise CIs and p-values comparing the combination treatment arm to the monotherapy arm.|Bonferroni-Holm procedure used for determining the statistical significance of the results.||-3.8|-5.2|<0.0001
71147186|NCT03714672|141788036|SUPERIORITY||Mean Difference (Final Values)|-3.2|||<|0.0001|TWO_SIDED|95.0|-3.9|-2.5|||ANCOVA|ANCOVA model with treatment, baseline pain intensity, and site as covariates.|LS means, 95% CIs, and pairwise CIs and p-values comparing the combination treatment arm to the monotherapy arm.|Bonferroni-Holm procedure used for determining the statistical significance of the results. The planned test was a test for non-inferiority.||-2.5|-3.9|<0.0001
71147187|NCT03714672|141788036|SUPERIORITY||Mean Difference (Final Values)|-2.8|||<|0.0001|TWO_SIDED|95.0|-3.5|-2.1|||ANCOVA|ANCOVA model with treatment, baseline pain intensity, and site as covariates.|LS means, 95% CIs, and pairwise CIs and p-values comparing the combination treatment arm to the monotherapy arm.|Bonferroni-Holm procedure used for determining the statistical significance of the results. The planned test was a test for non-inferiority.||-2.1|-3.5|<0.0001
70874706|NCT01111149|141233921|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for Urine Nicotine at Week 12||||>0.05
70874707|NCT01111149|141233922|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||Statistical analysis for 50% Reduction in Number of Cigarettes Smoked (Week 12)||||>0.05
70874708|NCT01111149|141233922|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||Statistical Analysis for 30% Reduction in Carbon Monoxide (Week 12)||||>0.05
70874709|NCT01111149|141233922|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||Statistical Analysis for 30% Reduction in Serum Cotinine (Week 12)||||>0.05
70874710|NCT01111149|141233922|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||Statistical Analysis for 30% Reduction in Urine Cotinine (Week 12)||||>0.05
70874711|NCT01111149|141233923|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Total Composite (Week 12)||||>0.05
70874712|NCT01111149|141233923|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Total Global (Week 12)||||>0.05
70874713|NCT01111149|141233923|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Affective Flattening (Week 12)||||>0.05
70874714|NCT01111149|141233923|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Alogia (Week 12)||||>0.05
70874715|NCT01111149|141233923|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Avolition (Week 12)||||>0.05
70874716|NCT01111149|141233923|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Anhedonia (Week 12)||||>0.05
70874717|NCT01111149|141233923|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Attention (Week 12)||||>0.05
70874718|NCT01111149|141233923|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis of Inappropriate Affect at Week 12||||>0.05
70874719|NCT01111149|141233924|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for CPT % Omissions (Week 12)||||>0.05
70874720|NCT01111149|141233924|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for CPT% commissions (Week 12)||||>0.05
70874721|NCT01111149|141233924|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for perseveration % (week 12)||||>0.05
70874722|NCT01111149|141233925|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Anxiety at week 12||||>0.05
70874723|NCT01111149|141233925|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Dizziness at week 12||||>0.05
70874724|NCT01111149|141233925|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Mania at week 12||||>0.05
70874725|NCT01111149|141233925|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for abnormal dreams at week 12||||>0.05
70874726|NCT01111149|141233925|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Abdominal Pain at week 12||||>0.05
70874727|NCT01111149|141233925|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Headache at week 12||||>0.05
70874728|NCT01111149|141233925|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Insomnia at week 12||||>0.05
70874729|NCT01111149|141233925|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Nausea at week 12||||>0.05
70874730|NCT01111149|141233925|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Psychosis at week 12||||>0.05
70874731|NCT01111149|141233925|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Dry Mouth at week 12||||>0.05
70874732|NCT01111149|141233925|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Chest Pain at Week 12||||>0.05
70874733|NCT01111149|141233925|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Irregular Heart Beat at week 12||||>0.05
70874734|NCT01111149|141233925|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Weakness/Fainting at week 12||||>0.05
70874735|NCT01111149|141233925|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Diarrhea at week 12||||>0.05
70874736|NCT01111149|141233925|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Vomiting at week 12||||>0.05
70874737|NCT01111149|141233925|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Constipation at week 12||||>0.05
70874738|NCT01111149|141233925|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Confusion at week 12||||>0.05
70874739|NCT01111149|141233925|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Irritability at week 12||||>0.05
71147188|NCT02345070|141788050|SUPERIORITY|The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least Square (LS) Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.05|=|0.6339|TWO_SIDED|95.0|-2.56|1.56||Threshold for significance at 0.05 level.|Mixed Models Analysis||SAR156597 200mg qw versus Placebo qw|A hierarchical testing procedure was used to control type I error. Testing was done sequentially in order the outcome measures were reported. Analyzed using Mixed Model for Repeated Measurements (MMRM) with fixed categorical effects of treatment arm, stratification factor (with/without background therapy), time point, treatment-by-time point interaction, stratification factor-by-treatment-by-time point interaction, and continuous fixed covariate of percent predicted FVC baseline.||1.56|-2.56|= 0.6339
71147189|NCT02345070|141788050|SUPERIORITY|The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|LS Mean Difference|0.56|STANDARD_ERROR_OF_MEAN|1.04|=|0.5874|TWO_SIDED|95.0|-1.47|2.6||Threshold for significance at 0.05 level.|Mixed Models Analysis||SAR156597 200mg q2w versus Placebo qw|A hierarchical testing procedure was used to control type I error. Testing was performed sequentially in the order outcome measures were reported (q2w dose group compared to placebo). Analysis was performed using MMRM with fixed categorical effects of treatment arm, stratification factor (with/without background therapy), time point, treatment-by-time point interaction, stratification factor-by-treatment-by-time point interaction, and continuous fixed covariate of percent predicted FVC baseline.||2.6|-1.47|= 0.5874
71147190|NCT03081117|141788054|SUPERIORITY|||||||0.669|||||||Fisher Exact|||Analysis of Enrolled group.||||0.669
71147191|NCT03081117|141788055|SUPERIORITY||Mean Difference (Net)|-0.3914||||0.0366|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of freedom = 14||Analysis for Intent-to-Treat group.||||0.0366
71147192|NCT03081117|141788055|SUPERIORITY||Mean Difference (Net)|-0.5146||||0.0103|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of freedom = 12||Analysis for Per Protocol group.||||0.0103
71147193|NCT03081117|141788058|SUPERIORITY||||||>|0.25||||||The threshold for statistical significance was p = 0.05.|Wald test, two-sided|||Comparisons of change from W0 to W24 between treatment and placebo are based on a mixed effects regression model using a two-sided Wald test of the interaction term for treatment and time.||||>0.25
71147194|NCT03081117|141788059|SUPERIORITY||||||>|0.25|||||||Wald test, two-sided|The threshold for statistical significance was p = 0.05.||Comparisons of change from W0 to W24 between treatment and placebo are based on a mixed effects regression model using a two-sided Wald test of the interaction term for treatment and time.||||>0.25
70874740|NCT01111149|141233925|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for drooling at week 12||||>0.05
70874741|NCT01111149|141233925|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Cold Sweats at week 12||||>0.05
70874742|NCT01111149|141233925|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Blurred Vision at week 12||||>0.05
70874743|NCT01111149|141233925|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Leg Pain/Cramps||||>0.05
70874744|NCT01111149|141233926|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for FTND (Week 12)||||>0.05
70874745|NCT01111149|141233926|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for MNWS 24 Hour Total (Week 12)||||>0.05
70874746|NCT01111149|141233926|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for MNWS 7 day total (Week 12)||||>0.05
70874747|NCT01111149|141233926|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for MNWS Resistance (Week 12)||||>0.05
70874748|NCT01111149|141233927|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis of Beck Depression Inventory (Week 12)||||>0.05
70874749|NCT01111149|141233928|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SAS (Week 12)||||>0.05
70874750|NCT01111149|141233928|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for BAS items 1-3 (week 12)||||>0.05
70874751|NCT01111149|141233928|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for BAS item 4 (Week 12)||||>0.05
70874752|NCT01111149|141233929|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for systolic blood pressure (Week 12)||||>0.05
70874753|NCT01111149|141233929|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for diastolic blood pressure (Week 12)||||>0.05
70874754|NCT01111149|141233930|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Vital Signs - Weight (Week 12)||||>0.05
70874755|NCT01111149|141233931|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Smoking Abstinence - Number of Cigarettes Smoked (Week 12)||||>0.05
70874756|NCT01111149|141233932|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Smoking Abstinence - Exhaled Carbon Monoxide (Week 12)||||>0.05
70874757|NCT01111149|141233933|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Vital Signs - Pulse (Week 12)||||>0.05
70874758|NCT01111149|141233934|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Lifetime Suicidal Ideation (Week 12)||||>0.05
70874759|NCT01111149|141233934|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Lifetime Suicide Attempts (Week 12)||||>0.05
70874760|NCT01111149|141233935|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SAPS Total Composite Score - Week 12||||>0.05
70874761|NCT01111149|141233935|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SAPS Total Global - Week 12||||>0.05
70874762|NCT01111149|141233935|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SAPS Hallucinations - Week 12||||>0.05
70874763|NCT01111149|141233935|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Delusions - Week 12||||>0.05
70874764|NCT01111149|141233935|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for SAPS Bizarre Behavior - Week 12||||>0.05
70874765|NCT01111149|141233935|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SAPS Thought Disorder - Week 12||||>0.05
70874766|NCT01111149|141233936|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for BPRS Total - Week 12||||>0.05
70874767|NCT01111149|141233936|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for BPRS Positive Subscale - Week 12||||>0.05
70874768|NCT01111149|141233936|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for BPRS Negative Subscale - Week 12||||>0.05
70874769|NCT01111149|141233936|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Mania Subscale - Week 12||||>0.05
70874770|NCT01111149|141233936|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Disorientation Subscale - Week 12||||>0.05
70874771|NCT01111149|141233936|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for BPRS Depression Subscale - Week 12||||>0.05
70874772|NCT01111149|141233937|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Hit Reaction Time - CPT (Week 12)||||>0.05
70874773|NCT01111149|141233938|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Variability of Standard Error - CPT (Week 12)||||>0.05
70874774|NCT01111149|141233939|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Detectibility (d') of Continuous Performance Test (Week 12)||||>0.05
70874775|NCT01111149|141233940|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Response Style Indicator (Beta) for CPT (week 12)||||>0.05
70874776|NCT01111149|141233941|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for WISDM Total (Week 12)||||>0.05
70874777|NCT01111149|141233941|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for WISDM Cognition (Week 12)||||>0.05
71147195|NCT03081117|141788060|SUPERIORITY||Unstandardized beta coefficient|-0.32|STANDARD_ERROR_OF_MEAN|0.27||0.244|TWO_SIDED||||||Wald test, two-sided|||Comparisons of change from W0 to W24 between treatment and placebo are based on a mixed effects regression model using a two-sided Wald test of the interaction term for treatment and time.||||0.244
70874778|NCT01111149|141233941|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for WISDM Craving (Week 12)||||>0.05
70874779|NCT01111149|141233942|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for MNWS % Urge to Smoke (Week 12)||||>0.05
70874780|NCT01111149|141233942|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for MNWS % Strong Urge (Week 12)||||>0.05
70874781|NCT01111149|141233943|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for AIMS Total (Week 12)||||>0.05
70874782|NCT01111149|141233943|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for AIMS Severity Index (Week 12)||||>0.05
70874783|NCT01111149|141233943|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for AIMS Global Score (Week 12)||||>0.05
70874784|NCT00759954|141233944|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated. The Wilcoxon signed rank test was used for a nonparametric comparison of Tmax values and a significant difference was defined a priori as p \< 0.05.|mean ratio|97.19|||<|0.05||90.0|91.31|103.45|||ANOVA|||||103.45|91.31|<0.05
70874785|NCT00759954|141233946|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated. The Wilcoxon signed rank test was used for a nonparametric comparison of Tmax values and a significant difference was defined a priori as p \< 0.05.|mean ratio|95.82|||<|0.05||90.0|92.93|98.8|||ANOVA|Analysis of Variance for the log-transformed AUC. The 90% confidence interval for the ratio of AUC(Test)/AUC(Ref) is provided.||||98.80|92.93|< 0.05
70874786|NCT00759954|141233947|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated. The Wilcoxon signed rank test was used for a nonparametric comparison of Tmax values and a significant difference was defined a priori as p \< 0.05.|mean ratio|98.1|||<|0.05||90.0|94.2|102.1|||ANOVA|||||102.1|94.2|< 0.05
70874787|NCT03791489|141234018|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
70874788|NCT03791489|141234019|SUPERIORITY||||||<|0.03||||||Threshold for statistical significance = p\<0.05.|t-test, 2 sided|||||||<0.03
70874789|NCT01648205|141234045|SUPERIORITY||Mean Difference (Final Values)|-1.6|STANDARD_DEVIATION|26.8||0.7958|TWO_SIDED|95.0|-14.1|11.0|||t-test, 2 sided|Paired t-test was used||||11.0|-14.1|0.7958
70874790|NCT01648205|141234046|SUPERIORITY||Median Difference (Final Values)|8.4|STANDARD_DEVIATION|35.9||0.3369|TWO_SIDED|95.0|-9.5|26.2|||t-test, 2 sided|Paired t-test was used||||26.2|-9.5|0.3369
70874791|NCT01414010|141234047|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||"Statistical analysis was performed using a variety of computer packages including XLstat, NCSS 2007, R and NCSS 2010"||||<0.05
70874792|NCT02142959|141234057|SUPERIORITY||LS Mean Difference Final Values|-0.1||||0.237|TWO_SIDED|65.0|-0.2|0.0||Omaveloxolone treatment arms were compared with Vehicle Lotion using a hierarchical testing strategy to control the overall type I error.|Mixed Models Analysis|Fixed factors: treatment grp \& wk of visit; covariates of site, smoking status \& surgery. Missing data imputed using each patient's worst-observation.||Comparison of omaveloxolone lotion pooled (0.5% and 3%) versus vehicle lotion||0.0|-0.2|0.237
70874793|NCT02142959|141234057|SUPERIORITY||LS Mean Difference Final Values|-0.1|||>|0.05|TWO_SIDED|95.0|-0.2|0.0||Omaveloxolone treatment arms were compared with Vehicle Lotion using a hierarchical testing strategy to control the overall type I error.|Mixed Models Analysis|Fixed factor: treatment grp \& visit wk; Covariates: site, smoking status \& breast surgery. Missing data imputed using each patient's worst-observation||Comparison of Omaveloxolone Lotion 0.5% versus Vehicle Lotion||0.0|-0.2|>0.05
70874794|NCT02142959|141234057|SUPERIORITY||LS Mean Difference Final Values|0.0|||>|0.05|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|Fixed factor: treatment grp \& visit wk; Covariates: site, smoking status \& breast surgery. Missing data imputed using each patient's worst-observation||Comparison of Omaveloxolone Lotion 3% versus Vehicle Lotion||0.1|-0.1|>0.05
70874795|NCT06092710|141234075|OTHER|Then, to see if the median of a particular group is diﬀerent from 0 (= no sensitivity: not feeling the diﬀerences in airflow induced by the diﬀerent tests given by the operator), Wilcoxon tests were performed on each group of data. If the p-value is small (less than 5%, ideally less than 1%), the null hypothesis that the score is identical to 0 is rejected.||||||0.05572|||||||Kruskal-Wallis|||Non-parametric tests on patient sensitivity, given the non-normal distribution, (based on the median of the data) were applied to analyse the diﬀerences between the groups (ST1+ ST2 according to the STATUS3 and STATUS4 classification criteria). To analyse any diﬀerences in sensitivity between patient groups, Kruskal-Wallis tests were applied. In this type of analysis, having a p-value greater than 1% and ideally greater than 5% would indicate the absence of diﬀerences between groups.||||0.05572
70874796|NCT06092710|141234075|OTHER|Wilcoxon tests were performed on each group of data. If the p-value is small (less than 5%, ideally less than 1%), the null hypothesis that the score is identical to 0 is rejected.|||||<|8e-07|||||||Wilcoxon (Mann-Whitney)|||to see if the median of a particular group is diﬀerent from 0 (= no sensitivity: not feeling the diﬀerences in airflow induced by the diﬀerent tests given by the operator), Wilcoxon tests were performed on each group of data. If the p-value is small (less than 5%, ideally less than 1%), the null hypothesis that the score is identical to 0 is rejected. In this case, it means that the patients in the test group feel the diﬀerences in airflow depending on their position.||||<0.0000008
71147196|NCT03081117|141788061|SUPERIORITY||||||>|0.25||||||The threshold for statistical significance was p = 0.05.|Wald test, two-sided|||Comparisons of change from W0 to W24 between treatment and placebo are based on a mixed effects regression model using a two-sided Wald test of the interaction term for treatment and time.||||>0.25
71147197|NCT03081117|141788062|SUPERIORITY||||||>|0.25|||||||Wald test, two-sided|The threshold for statistical significance was p = 0.05.||Comparisons of change from W0 to W24 between treatment and placebo are based on a mixed effects regression model using a two-sided Wald test of the interaction term for treatment and time.||||>0.25
71147198|NCT03081117|141788063|SUPERIORITY||||||>|0.25|||||||Wald test, two-sided|The threshold for statistical significance was p = 0.05.||Comparisons of change from W0 to W24 between treatment and placebo are based on a mixed effects regression model using a two-sided Wald test of the interaction term for treatment and time.||||>0.25
70874797|NCT06092710|141234075|OTHER|Wilcoxon tests were performed on each group of data. If the p-value is small (less than 5%, ideally less than 1%), the null hypothesis that the score is identical to 0 is rejected. In this case, it means that the patients in the test group feel the diﬀerences in airflow depending on their position.|||||<|1e-07|||||||Wilcoxon (Mann-Whitney)|||to see if the median of a particular group is diﬀerent from 0 (= no sensitivity: not feeling the diﬀerences in airflow induced by the diﬀerent tests given by the operator), Wilcoxon tests were performed on each group of data. If the p-value is small (less than 5%, ideally less than 1%), the null hypothesis that the score is identical to 0 is rejected. In this case, it means that the patients in the test group feel the diﬀerences in airflow depending on their position.||||<0.0000001
70874798|NCT06092710|141234076|SUPERIORITY|||||||1.06e-06||||||Confidence level used: 0.95 Tukey multiple comparisons of means (95% family-wise confidence level)|ANOVA|||Parametric tests on the prediction of patients' pathological status with SFI (Intermediate Final Score) For these analyses, as the SFI score follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value, a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another.||||0.00000106
70874799|NCT06092710|141234076|SUPERIORITY|||||||48||||||Confidence level used: 0.95 Tukey multiple comparisons of means (95% family-wise confidence level)|ANOVA|||"Parametric tests on the prediction of patients' pathological status with SFT score (Final Total score):~For these analyses, as SFT score follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value, a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0000000048
70874800|NCT06092710|141234076|SUPERIORITY||Odds Ratio (OR)|8.73||||7.7e-07|TWO_SIDED||||||Fisher Exact|||"Determination of cut-oﬀ values for SFI:~The Cutoﬀ\_final txt file includes the various sensitivity and specificity calculations as well as the Youden index in order to determine the best cut-oﬀ value (largest Youden). The ROC curves allow the values in the file to be appreciated graphically."||||0.00000077
70874801|NCT06092710|141234076|SUPERIORITY||Odds Ratio (OR)|9.37||||6.9e-07|TWO_SIDED||||||Fisher Exact|||"Determination of cut-oﬀ values for SFT:~The Cutoﬀ\_final txt file includes the various sensitivity and specificity calculations as well as the Youden index in order to determine the best cut-oﬀ value (largest Youden). The ROC curves allow the values in the file to be appreciated graphically."||||0.00000069
70874802|NCT06092710|141234077|SUPERIORITY|||||||0.0142266|||||||TUKEY TEST|||"Parametric tests on the prediction of patients' pathological status (SFI and SFT scores):~For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0.0142266
70874803|NCT06092710|141234077|SUPERIORITY|||||||0.0023308|||||||TUKEY TEST|||"Parametric tests on the prediction of patients' pathological status (SFI and SFT scores):~For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0.0023308
70874804|NCT06092710|141234077|SUPERIORITY|||||||0.0023308|||||||TUKEY TEST|||"Parametric tests on the prediction of patients' pathological status (SFI and SFT scores):~For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0.0023308
70874805|NCT06092710|141234077|SUPERIORITY|||||||0.9915779|||||||TUKEY TEST|||"Parametric tests on the prediction of patients' pathological status (SFI and SFT scores):~For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0.9915779
70874806|NCT06092710|141234077|SUPERIORITY|||||||0.9999943|||||||TUKEY TEST|||"Parametric tests on the prediction of patients' pathological status (SFI and SFT scores):~For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0.9999943
70874807|NCT06092710|141234077|SUPERIORITY|||||||0.9905111|||||||TUKEY TEST|||"Parametric tests on the prediction of patients' pathological status (SFI and SFT scores):~For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0.9905111
70874808|NCT00850564|141234078|SUPERIORITY_OR_OTHER||||||<|0.005||95.0|||||Paired t-test|||Paired t-test comparing baseline and 2 week mean overnight growth hormone||||<0.005
71147199|NCT03081117|141788064|SUPERIORITY||Mean Difference (Net)|0.0031351||||0.366|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of freedom = 13||Analysis for All Available group (participants who had both Baseline and Week 24 scans).||||0.366
70874809|NCT00850564|141234079|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Paired t-test|||Paired t-test comparing insulin stimulated glucose uptake (M) between baseline and 2 week visits.||||0.61
71147200|NCT03081117|141788064|SUPERIORITY||Mean Difference (Net)|0.0025586||||0.505|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees fo freedom = 10||Analysis for Per Protocol group.||||0.505
71147201|NCT03081117|141788065|SUPERIORITY||Mean Difference (Net)|0.00000061||||0.98|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of freedom = 13||Analysis for All Available group (participants who had both Baseline and Week 24 scans).||||0.98
71147202|NCT03081117|141788065|SUPERIORITY||Mean Difference (Net)|-0.0000054||||0.86|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of freedom = 10||Analysis for Per Protocol group.||||0.86
71147203|NCT00321620|141788082|NON_INFERIORITY_OR_EQUIVALENCE|A synthesis method was used for the non-inferiority test for the hypothesis that denosumab preserves as least 50% of the effect of zoledronic acid vs. placebo.|Hazard Ratio (HR)|0.82||||0.0002||95.0|0.71|0.95|||Regression, Cox||Stratified by the randomization stratification factors (previous skeletal-related event, prostate-specific antigen level, and current chemotherapy)|||0.95|0.71|0.0002
71147204|NCT00321620|141788083|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.0085||95.0|0.71|0.95|||Regression, Cox|P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure.|Stratified by the randomization stratification factors (previous skeletal-related event, prostate-specific antigen level, and current chemotherapy).|||0.95|0.71|0.0085
71147205|NCT00321620|141788084|SUPERIORITY_OR_OTHER||Rate ratio|0.82||||0.0085||95.0|0.71|0.94|||Anderson-Gill model|P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure.|Stratified by the randomization stratification factors (previous skeletal-related event, prostate-specific antigen level, and current chemotherapy).|||0.94|0.71|0.0085
71147206|NCT03829228|141788085|SUPERIORITY||Mean Difference (Net)|1.31|||<|0.0001|TWO_SIDED|95.0|0.62|2.01||The threshold for statistical significance was p=0.01|ANOVA||Treatment Difference= Visit5-Baseline|||2.01|0.62|<0.0001
70874810|NCT05355805|141234081|SUPERIORITY||Risk Difference (RD)|8.27|STANDARD_ERROR_OF_MEAN|8.075||0.3055|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/Janus Kinase (JAK) inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error was estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR75."||||0.3055
70874811|NCT05355805|141234081|SUPERIORITY||Risk Difference (RD)|4.19|STANDARD_ERROR_OF_MEAN|8.427||0.6192|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error was estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR75."||||0.6192
70874812|NCT05355805|141234084|SUPERIORITY||Risk Difference (RD)|10.14|STANDARD_ERROR_OF_MEAN|7.229||0.1606|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR90."||||0.1606
70874813|NCT05355805|141234084|SUPERIORITY||Risk Difference (RD)|4.79|STANDARD_ERROR_OF_MEAN|7.294||0.5116|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR90."||||0.5116
70874814|NCT05355805|141234085|SUPERIORITY||Risk Difference (RD)|13.67|STANDARD_ERROR_OF_MEAN|7.019||0.0514|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR100."||||0.0514
70874815|NCT05355805|141234085|SUPERIORITY||Risk Difference (RD)|6.56|STANDARD_ERROR_OF_MEAN|6.764||0.3322|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR100."||||0.3322
71147207|NCT03829228|141788086|SUPERIORITY||||||<|0.0001||||||The threshold for statistical significance was p=0.01|Regression, Logistic|||||||<0.0001
71147208|NCT03829228|141788087|SUPERIORITY||Mean Difference (Net)|1.31|||<|0.0001|TWO_SIDED|95.0|0.64|1.98||The threshold for statistical significance was p=0.01|ANOVA||Treatment difference=Visit5-Baseline|||1.98|0.64|<0.0001
71147209|NCT03829228|141788088|SUPERIORITY||||||<|0.0001||||||The threshold for statistical significant was p=0.01.|Regression, Logistic|||||||<0.0001
71147210|NCT02844569|141788089|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
71147211|NCT02844569|141788090|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
71147212|NCT02844569|141788091|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||||||0.66
70874816|NCT05355805|141234086|SUPERIORITY||Risk Difference (RD)|8.63|STANDARD_ERROR_OF_MEAN|8.78||0.3258|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR50."||||0.3258
71147213|NCT01887327|141788096|OTHER||LS Mean Difference vs Placebo|-31.64|||=|2.1e-06|TWO_SIDED|95.0|-44.0|-19.283|||LS Mean Difference vs Placebo|||||-19.283|-44.000|=0.0000021
71147214|NCT01887327|141788096|OTHER||LS Mean Difference vs Placebo|-27.4|||=|2.6e-05|TWO_SIDED|95.0|-39.657|-15.142|||LS Mean Difference vs Placebo|||||-15.142|-39.657|=0.0000260
71147215|NCT03027609|141788100|SUPERIORITY|comparison between the treatment and placebo|Risk Difference (RD)|-5.54||||0.6154|TWO_SIDED|95.0|-21.9|10.8||P-value was obtained with the stratified CMH test adjusted for baseline randomization strata|Cochran-Mantel-Haenszel|||||10.8|-21.9|0.6154
71147216|NCT03027609|141788101|SUPERIORITY||Risk Difference (RD)|4.01||||0.8426|TWO_SIDED|95.0|-18.5|10.5||P-value was obtained with the stratified CMH test adjusted for baseline randomization strata|Cochran-Mantel-Haenszel|||Comparison between the treatment and placebo||10.5|-18.5|0.8426
71147217|NCT03027609|141788102|SUPERIORITY|comparison between the treatment and placebo|P value CMH|3.6||||0.3562|TWO_SIDED|95.0|-13.1|20.3||P-value was obtained with the stratified CMH test adjusted for baseline randomization strata|Cochran-Mantel-Haenszel|||Comparison between the treatment and placebo||20.3|-13.1|0.3562
71147218|NCT03027609|141788103|SUPERIORITY|Comparison between the treatment and placebo|P value CMH|-2.81||||0.8472|TWO_SIDED|95.0|-18.9|13.2||P-value was obtained with the stratified CMH test adjusted for baseline randomization strata|Cochran-Mantel-Haenszel|||||13.2|-18.9|0.8472
71147219|NCT03027609|141788104|SUPERIORITY||Mean Difference (Final Values)|22.3||||0.4616|TWO_SIDED|95.0|-16.2|60.6||Marginally statistically significant only if p\<0.1|Chi-squared|||Data for Day 14||60.6|-16.2|0.4616
71147220|NCT03027609|141788104|SUPERIORITY||Mean Difference (Final Values)|22.3||||0.4053|TWO_SIDED|95.0|-13.3|57.8||Data for Day 21|Chi-squared|||Data for Day 21||57.8|-13.3|0.4053
71147221|NCT03027609|141788105|SUPERIORITY||Mean Difference (Final Values)|38.1||||0.0833|TWO_SIDED|90.0|-14.8|90.9||Marginally statistically significant only if p\<0.1|Chi-squared|||Data for Day 14||90.9|-14.8|0.0833
70874817|NCT05355805|141234086|SUPERIORITY||Risk Difference (RD)|7.28|STANDARD_ERROR_OF_MEAN|8.775||0.4068|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR50."||||0.4068
70874818|NCT05355805|141234087|SUPERIORITY|Predictors in the regression model for missing values at Week 16 are Baseline Hurley stage, baseline abscess count, baseline inflammatory nodule count, baseline draining fistula count, sex, race, age, BMI and Prior Biologic/JAK inhibitor use for HS plus counts of abscess, inflammatory nodule, and draining fistula at prior scheduled assessment. Missing flare values in both the placebo and izokibep groups are imputed using observed data from the placebo group only.|Risk Difference (RD)|-7.4|STANDARD_ERROR_OF_MEAN|7.661||0.3329|TWO_SIDED|||||The estimated risk difference divided by the standard error will be used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Missing data of abscess and inflammatory nodules counts at scheduled visits are imputed assuming monotone missingness pattern."||||0.3329
71147222|NCT03027609|141788105|SUPERIORITY||Mean Difference (Net)|23.8||||0.5151|TWO_SIDED|90.0|-30.5|78.1||Data for Day 21|Chi-squared|Marginally statistically significant only if p\<0.1 Day 21||Data for Day 21||78.1|-30.5|0.5151
71147223|NCT01462370|141788110|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority margin is -3.7 units.|Difference in LS Means|0.89||||0.043|TWO_SIDED|95.0|0.03|1.76||A priori threshold for statistical significance = \<0.025 (one-sided).|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||With at least 128 participants, the study had a 92% power to establish that etoricoxib is noninferior to ibuprofen (null hypothesis). The power and sample size were based on the following assumptions: 1) an approximately 15% protocol violation rate, 2) a noninferiority margin of -3.7 units (etoricoxib minus ibuprofen), and 3) an intrapatient standard deviation of 8 units.||1.76|0.03|0.043
71147224|NCT01462370|141788111|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.2||||0.768|TWO_SIDED|95.0|-1.16|1.57||A nominal threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||1.57|-1.16|0.768
71147225|NCT01462370|141788112|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.26||||0.007|TWO_SIDED|95.0|0.07|0.45||A nominal threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.45|0.07|0.007
71147226|NCT01462370|141788113|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.36|||<|0.001|TWO_SIDED|95.0|0.17|0.54||A nominal threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.54|0.17|<0.001
71147227|NCT01462370|141788114|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.89||||0.371|TWO_SIDED|95.0|0.7|1.14||A priori threshold for statistical significance = \<0.05.|Regression, Cox|Adjusted for treatment, period, and baseline pain intensity.||||1.14|0.70|0.371
71147228|NCT01462370|141788115|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.1||||0.051|TWO_SIDED|95.0|0.0|0.2||A priori threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.20|-0.00|0.051
71147229|NCT01462370|141788116|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference in LS Means|0.17||||0.019|TWO_SIDED|95.0|0.03|0.32||A priori threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.32|0.03|0.019
71147230|NCT01462370|141788118|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.21|||<|0.001|TWO_SIDED|95.0|0.1|0.31||A priori threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.31|0.10|<0.001
71147231|NCT01462370|141788119|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.28||||0.002|TWO_SIDED|95.0|0.1|0.45||A priori threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.45|0.10|0.002
71147232|NCT01462370|141788120|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.11||||0.011|TWO_SIDED|95.0|0.03|0.2||A priori threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.20|0.03|0.011
71147233|NCT01462370|141788121|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.26||||0.004|TWO_SIDED|95.0|0.08|0.44||A priori threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.44|0.08|0.004
71147234|NCT01462370|141788122|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.6||||0.112|TWO_SIDED|95.0|0.9|2.87||A priori threshold for statistical significance = \<0.05.|Regression, Logistic|Adjusted for treatment, period, and baseline pain intensity.||||2.87|0.90|0.112
71147235|NCT01462370|141788123|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.97||||0.019|TWO_SIDED|95.0|1.12|3.45||A priori threshold for statistical significance = \<0.05.|Regression, Logistic|Adjusted for treatment, period, and baseline pain intensity.||||3.45|1.12|0.019
71147236|NCT05106894|141788124|EQUIVALENCE|Adjusted difference between groups in composite scores calculated using an ordinary least squares linear regression model (with adjustments for sex of child, caregiver educational level, poverty score, birth weight and change in length for age Z score from 0 to 6 months).|Median Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-7.4|5.5||||||||5.5|-7.4|
71147237|NCT05106894|141788125|EQUIVALENCE|Adjusted difference between groups in composite scores calculated using an ordinary least squares linear regression model (with adjustments for sex of child, caregiver educational level, poverty score, birth weight and change in length for age Z score from 0 to 6 months).|Median Difference (Final Values)|-2.3|||||TWO_SIDED|95.0|-8.3|3.6||||||||3.6|-8.3|
71147238|NCT05106894|141788126|EQUIVALENCE|Adjusted difference between groups in composite scores calculated using an ordinary least squares linear regression model (with adjustments for sex of child, caregiver educational level, poverty score, birth weight and change in length for age Z score from 0 to 6 months).|Mean Difference (Final Values)|-1.8|||||TWO_SIDED|95.0|-5.6|2.1||||||||2.1|-5.6|
71147239|NCT00981656|141788150|OTHER|No testing is done, conclusions are made based on the confidence interval.||||||||||||||||Null hypothesis = this treatment will result in 75% of participants free from radical cystectomy at 3 years. A lower confidence bound of 60% will be promising enough to pursue this regimen further. A sample size of 33 analyzable patients provides a one-sided 97.5% lower bound of 60% relative to the hypothesized 75%. In terms of type I error, this design provides a 2.5% chance of observing a 3-year percentage less than 60% if the true rate is 75%.|If the lower confidence interval (CI) limit was above 60% then the regimen would be considered promising enough to warrant further study for this treatment regimen. If the lower limit was below 25% then the treatment would not be considered worthy of further study. If the lower limit fell between 25% and 60%, the investigators would consider the possibility of further investigation.|||
71147240|NCT02121158|141788197|EQUIVALENCE|Unadjusted|Hazard Ratio (HR)|0.915||||0.7457|TWO_SIDED|95.0|0.534|1.568|||Cox Proportional Hazards|||||1.568|0.534|0.7457
71147241|NCT03773978|141788225|SUPERIORITY||Hazard Ratio (HR)|0.241|||<|0.001|TWO_SIDED|95.0|0.128|0.453|||Log Rank|||||0.453|0.128|<0.001
71147242|NCT03773978|141788226|SUPERIORITY||Odds Ratio (OR)|2.72||||0.052|TWO_SIDED|95.0|0.99|7.46|||Regression, Logistic|||at week 16||7.46|0.99|0.052
71147243|NCT03773978|141788226|SUPERIORITY||Odds Ratio (OR)|3.64||||0.002|TWO_SIDED|95.0|1.6|8.28|||Regression, Logistic|||at week 20||8.28|1.60|0.002
71147244|NCT03773978|141788226|SUPERIORITY||Odds Ratio (OR)|4.34|||<|0.001|TWO_SIDED|95.0|2.0|9.41|||Regression, Logistic|||at week 24||9.41|2.00|<0.001
71147245|NCT03773978|141788226|SUPERIORITY||Odds Ratio (OR)|3.37||||0.001|TWO_SIDED|95.0|1.62|7.01|||Regression, Logistic|||at week 28||7.01|1.62|0.001
71147246|NCT03773978|141788226|SUPERIORITY||Odds Ratio (OR)|3.0||||0.002|TWO_SIDED|95.0|1.48|6.07|||Regression, Logistic|||at week 32||6.07|1.48|0.002
71147247|NCT03773978|141788226|SUPERIORITY||Odds Ratio (OR)|3.25|||<|0.001|TWO_SIDED|95.0|1.62|6.52|||Regression, Logistic|||at week 36||6.52|1.62|<0.001
71147248|NCT03773978|141788226|SUPERIORITY||Odds Ratio (OR)|3.7|||<|0.001|TWO_SIDED|95.0|1.85|7.41|||Regression, Logistic|||at week 40||7.41|1.85|<0.001
71147249|NCT03773978|141788226|SUPERIORITY||Odds Ratio (OR)|3.27|||<|0.001|TWO_SIDED|95.0|1.65|6.5|||Regression, Logistic|||at week 44||6.50|1.65|<0.001
71147250|NCT03773978|141788227|SUPERIORITY||Odds Ratio (OR)|1.25||||0.568|TWO_SIDED|95.0|0.59|2.65|||Regression, Logistic|||at week 16||2.65|0.59|0.568
71147251|NCT03773978|141788227|SUPERIORITY||Odds Ratio (OR)|2.92||||0.004|TWO_SIDED|95.0|1.4|6.09|||Regression, Logistic|||at week 20||6.09|1.40|0.004
71147252|NCT03773978|141788227|SUPERIORITY||Odds Ratio (OR)|4.38|||<|0.001|TWO_SIDED|95.0|2.1|9.15|||Regression, Logistic|||at week 24||9.15|2.10|<0.001
71147253|NCT03773978|141788227|SUPERIORITY||Odds Ratio (OR)|3.09||||0.002|TWO_SIDED|95.0|1.51|6.32|||Regression, Logistic|||at week 28||6.32|1.51|0.002
71147254|NCT03773978|141788227|SUPERIORITY||Odds Ratio (OR)|2.99||||0.003|TWO_SIDED|95.0|1.47|6.11|||Regression, Logistic|||at week 32||6.11|1.47|0.003
71147255|NCT03773978|141788227|SUPERIORITY||Odds Ratio (OR)|2.84||||0.003|TWO_SIDED|95.0|1.44|5.6|||Regression, Logistic|||at week 36||5.60|1.44|0.003
71147256|NCT03773978|141788227|SUPERIORITY||Odds Ratio (OR)|3.49|||<|0.001|TWO_SIDED|95.0|1.74|6.97|||Regression, Logistic|||at week 40||6.97|1.74|<0.001
71147257|NCT03773978|141788227|SUPERIORITY||Odds Ratio (OR)|2.87||||0.002|TWO_SIDED|95.0|1.46|5.66|||Regression, Logistic|||at week 44||5.66|1.46|0.002
71147258|NCT03773978|141788228|SUPERIORITY||Odds Ratio (OR)|0.99||||0.972|TWO_SIDED|95.0|0.52|1.87|||Regression, Logistic|||at week 16||1.87|0.52|0.972
71147259|NCT03773978|141788228|SUPERIORITY||Odds Ratio (OR)|2.47||||0.008|TWO_SIDED|95.0|1.27|4.81|||Regression, Logistic|||at week 20||4.81|1.27|0.008
71147260|NCT03773978|141788228|SUPERIORITY||Odds Ratio (OR)|2.57||||0.005|TWO_SIDED|95.0|1.33|4.97|||Regression, Logistic|||at week 24||4.97|1.33|0.005
71147261|NCT03773978|141788228|SUPERIORITY||Odds Ratio (OR)|3.06|||<|0.001|TWO_SIDED|95.0|1.57|5.94|||Regression, Logistic|||at week 28||5.94|1.57|<0.001
71147262|NCT03773978|141788228|SUPERIORITY||Odds Ratio (OR)|2.42||||0.009|TWO_SIDED|95.0|1.25|4.71|||Regression, Logistic|||at week 32||4.71|1.25|0.009
71147263|NCT03773978|141788228|SUPERIORITY||Odds Ratio (OR)|2.8||||0.003|TWO_SIDED|95.0|1.43|5.47|||Regression, Logistic|||at week 36||5.47|1.43|0.003
71147264|NCT03773978|141788228|SUPERIORITY||Odds Ratio (OR)|2.93||||0.002|TWO_SIDED|95.0|1.47|5.83|||Regression, Logistic|||at week 40||5.83|1.47|0.002
71147265|NCT03773978|141788228|SUPERIORITY||Odds Ratio (OR)|1.93||||0.052|TWO_SIDED|95.0|0.99|3.74|||Regression, Logistic|||at week 44||3.74|0.99|0.052
70874819|NCT05355805|141234087|SUPERIORITY|Predictors in the regression model for missing values at Week 16 are Baseline Hurley stage, baseline abscess count, baseline inflammatory nodule count, baseline draining fistula count, sex, race, age, BMI and Prior Biologic/JAK inhibitor use for HS plus counts of abscess, inflammatory nodule, and draining fistula at prior scheduled assessment. Missing flare values in both the placebo and izokibep groups are imputed using observed data from the placebo group only.|Risk Difference (RD)|4.06|STANDARD_ERROR_OF_MEAN|7.574||0.5882|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Missing data of abscess and inflammatory nodules counts at scheduled visits are imputed assuming monotone missingness pattern."||||0.5882
70874820|NCT05355805|141234088|SUPERIORITY||Risk Difference (RD)|7.31|STANDARD_ERROR_OF_MEAN|11.995||0.5422|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.||||0.5422
71147266|NCT03773978|141788229|SUPERIORITY||Odds Ratio (OR)|1.35||||0.409|TWO_SIDED|95.0|0.66|2.75|||Regression, Logistic|||at week 16||2.75|0.66|0.409
71147267|NCT03773978|141788229|SUPERIORITY||Odds Ratio (OR)|2.13||||0.03|TWO_SIDED|95.0|1.07|4.23|||Regression, Logistic|||at week 20||4.23|1.07|0.030
71147268|NCT03773978|141788229|SUPERIORITY||Odds Ratio (OR)|2.36||||0.022|TWO_SIDED|95.0|1.13|4.92|||Regression, Logistic|||at week 24||4.92|1.13|0.022
71147269|NCT03773978|141788229|SUPERIORITY||Odds Ratio (OR)|2.05||||0.04|TWO_SIDED|95.0|1.03|4.08|||Regression, Logistic|||at week 28||4.08|1.03|0.040
71147270|NCT03773978|141788229|SUPERIORITY||Odds Ratio (OR)|2.13||||0.032|TWO_SIDED|95.0|1.07|4.24|||Regression, Logistic|||at week 32||4.24|1.07|0.032
71147271|NCT03773978|141788229|SUPERIORITY||Odds Ratio (OR)|1.71||||0.132|TWO_SIDED|95.0|0.85|3.42|||Regression, Logistic|||at week 36||3.42|0.85|0.132
71147272|NCT03773978|141788229|SUPERIORITY||Odds Ratio (OR)|2.02||||0.05|TWO_SIDED|95.0|1.0|4.1|||Regression, Logistic|||at week 40||4.10|1.00|0.050
71147273|NCT03773978|141788229|SUPERIORITY||Odds Ratio (OR)|2.32||||0.019|TWO_SIDED|95.0|1.15|4.71|||Regression, Logistic|||at week 44||4.71|1.15|0.019
71147274|NCT03773978|141788230|SUPERIORITY||Odds Ratio (OR)|0.8||||0.62|TWO_SIDED|95.0|0.33|1.92|||Regression, Logistic|||at week 16||1.92|0.33|0.620
70955635|NCT03973931|141414992|NON_INFERIORITY|Analysis of the longitudinal data (12 observations per patient) and estimated absolute differences in PDC between treatment group and usual care was analyzed using Generalized Estimating Equation (GEE) model with an identity link and independence with unequal variances for the covariance structure was used.|||||<|0.05||||||To account for multiple treatment comparisons significance levels of 0.05/3, and if any test was significant, a significance level of (R/3)\*(0.05/3) using the Holm method was used for the 3 pairwise comparisons, R=number of significant stage 1 tests.|GEE|||||||<0.05
70955636|NCT02516332|141414996|OTHER|||||||0.038|||||||ANCOVA|||||||0.038
70955637|NCT02516332|141414996|OTHER|||||||0.002|||||||ANCOVA|||||||0.002
70955638|NCT02516332|141415001|OTHER|||||||0.011|||||||Regression, Linear|||||||0.011
70955639|NCT02516332|141415001|OTHER|||||||0.036|||||||Regression, Linear|||||||0.036
70955640|NCT02704754|141415006|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<.05
70955641|NCT03809429|141415009|OTHER||Difference|1.31||||0.0185|TWO_SIDED|95.0|0.22|2.4|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||||2.40|0.22|0.0185
70874821|NCT05355805|141234088|SUPERIORITY||Risk Difference (RD)|-5.23|STANDARD_ERROR_OF_MEAN|11.77||0.6569|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.||||0.6569
70874822|NCT05355805|141234089|SUPERIORITY||Risk Difference (RD)|7.48|STANDARD_ERROR_OF_MEAN|8.951||0.4031|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.||||0.4031
70874823|NCT05355805|141234089|SUPERIORITY||Risk Difference (RD)|21.27|STANDARD_ERROR_OF_MEAN|9.959||0.0327|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.||||0.0327
70874824|NCT02345850|141234131|SUPERIORITY||Hazard Ratio (HR)|0.805||||0.2368|TWO_SIDED|95.0|0.562|1.154||The primary pairwise comparisons are tested at a Bonferroni adjusted significance level of 0.05/3.|Log Rank|||The primary null hypothesis of the study is that there is no difference of the CRFS hazard ratio between CD34 select graft vs. Tac/MTX Control. The data in primary outcome table provides point estimates at specific time points (1 year and 2 years post randomization). The statistics in this session provides comparisons between different arms for the entire period of the study.||1.154|0.562|0.2368
70955642|NCT03809429|141415012|OTHER||Difference|1.14||||0.0281|TWO_SIDED|95.0|0.12|2.15|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||\>=10 mm at end of stimulation||2.15|0.12|0.0281
70955643|NCT03809429|141415012|OTHER||Difference|0.99||||0.0258|TWO_SIDED|95.0|0.12|1.86|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||\>=12 mm at end of stimulation||1.86|0.12|0.0258
70955644|NCT03809429|141415012|OTHER||Difference|0.58||||0.0672|TWO_SIDED|95.0|-0.04|1.2|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||\>=15 mm at end of stimulation||1.20|-0.04|0.0672
70955645|NCT03809429|141415012|OTHER||Difference|0.21||||0.339|TWO_SIDED|95.0|-0.22|0.63|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||\>=17 mm at end of stimulation||0.63|-0.22|0.3390
70955646|NCT03809429|141415014|OTHER||Difference|1.11||||0.0962|TWO_SIDED|95.0|-0.2|2.41|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||||2.41|-0.20|0.0962
70874825|NCT02345850|141234131|SUPERIORITY||Hazard Ratio (HR)|0.864||||0.4134|TWO_SIDED|95.0|0.609|1.228||The primary pairwise comparisons are tested at a Bonferroni adjusted significance level of 0.05/3.|Log Rank|||The primary null hypothesis of the study is that there is no difference of the CRFS hazard ratio between Post-Transplant Cyclophosphamide vs. Tac/MTX Control. The data in primary outcome table provides point estimates. The statistics in this session provides comparisons between different arms for the entire period of the study.||1.228|0.609|0.4134
70874826|NCT02345850|141234131|SUPERIORITY||Hazard Ratio (HR)|0.933||||0.7166|TWO_SIDED|95.0|0.643|1.355||The primary pairwise comparisons are tested at a Bonferroni adjusted significance level of 0.05/3.|Log Rank|||The primary null hypothesis of the study is that there is no difference of the CRFS hazard ratio between CD34 select graft vs. Post-Transplant Cyclophosphamide. The data in primary outcome table provides point estimates. The statistics in this session provides comparisons between different arms for the entire period of the study.||1.355|0.643|0.7166
70874827|NCT02345850|141234131|SUPERIORITY|||||||0.386||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the CRFS hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk. The data in primary outcome table provides point estimates. The statistics in this session provides comparisons between different arms for the entire period of the study.||||0.386
70874828|NCT02345850|141234131|SUPERIORITY|||||||0.461||||||A Bonferroni adjusted significance level of 0.05/3=0.0167 is used for each of three interaction tests to account for multiple testing.|Cox proportional hazards regression|||Subgroup analyses are conducted for CRFS according to disease, disease risk and age. Interaction tests between treatment group and subgroup are conducted within a Cox proportional hazards regression model with treatment, subgroup, and a treatment\*subgroup interaction term. The null hypothesis is that there is no Interaction between treatment group and disease risk (Low/Intermediate vs. High) for CRFS.||||0.461
70874829|NCT02345850|141234131|SUPERIORITY|||||||0.115||||||Cox proportional hazards regression|Cox proportional hazards regression|||Subgroup analyses are conducted for CRFS according to disease, disease risk and age. Interaction tests between treatment group and subgroup are conducted within a Cox proportional hazards regression model with treatment, subgroup, and a treatment\*subgroup interaction term. The null hypothesis is that there is no Interaction between treatment group and Age (\<=50 vs. \>50) for CRFS.||||0.115
70955647|NCT03809429|141415016|OTHER||Difference|0.51||||0.1894|TWO_SIDED|95.0|-0.25|1.27|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||Number of embryos||1.27|-0.25|0.1894
70955648|NCT03809429|141415016|OTHER||Difference|-0.03||||0.9361|TWO_SIDED|95.0|-0.68|0.63|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||Number of Good-quality embryos||0.63|-0.68|0.9361
71147275|NCT03773978|141788230|SUPERIORITY||Odds Ratio (OR)|1.3||||0.492|TWO_SIDED|95.0|0.61|2.78|||Regression, Logistic|||at week 20||2.78|0.61|0.492
71147276|NCT03773978|141788230|SUPERIORITY||Odds Ratio (OR)|1.17||||0.715|TWO_SIDED|95.0|0.5|2.75|||Regression, Logistic|||at week 24||2.75|0.50|0.715
71147277|NCT03773978|141788230|SUPERIORITY||Odds Ratio (OR)|1.4||||0.384|TWO_SIDED|95.0|0.66|2.99|||Regression, Logistic|||at week 28||2.99|0.66|0.384
71147278|NCT03773978|141788230|SUPERIORITY||Odds Ratio (OR)|1.47||||0.311|TWO_SIDED|95.0|0.7|3.1|||Regression, Logistic|||at week 32||3.10|0.70|0.311
71147279|NCT03773978|141788230|SUPERIORITY||Odds Ratio (OR)|1.58||||0.231|TWO_SIDED|95.0|0.75|3.34|||Regression, Logistic|||at week 36||3.34|0.75|0.231
71147280|NCT03773978|141788230|SUPERIORITY||Odds Ratio (OR)|1.82||||0.129|TWO_SIDED|95.0|0.84|3.95|||Regression, Logistic|||at week 40||3.95|0.84|0.129
71147281|NCT03773978|141788230|SUPERIORITY||Odds Ratio (OR)|2.23||||0.043|TWO_SIDED|95.0|1.02|4.84|||Regression, Logistic|||at week 44||4.84|1.02|0.043
71147282|NCT03773978|141788231|SUPERIORITY||Odds Ratio (OR)|1.1||||0.853|TWO_SIDED|95.0|0.4|2.98|||Regression, Logistic|||at week 16||2.98|0.40|0.853
71147283|NCT03773978|141788231|SUPERIORITY||Odds Ratio (OR)|0.7||||0.432|TWO_SIDED|95.0|0.29|1.71|||Regression, Logistic|||at week 20||1.71|0.29|0.432
71147284|NCT03773978|141788231|SUPERIORITY||Odds Ratio (OR)|0.98||||0.96|TWO_SIDED|95.0|0.41|2.31|||Regression, Logistic|||at week 24||2.31|0.41|0.960
71147285|NCT03773978|141788231|SUPERIORITY||Odds Ratio (OR)|1.71||||0.215|TWO_SIDED|95.0|0.73|4.01|||Regression, Logistic|||at week 28||4.01|0.73|0.215
71147286|NCT03773978|141788231|SUPERIORITY||Odds Ratio (OR)|1.8||||0.173|TWO_SIDED|95.0|0.77|4.22|||Regression, Logistic|||at week 32||4.22|0.77|0.173
71147287|NCT03773978|141788231|SUPERIORITY||Odds Ratio (OR)|1.46||||0.367|TWO_SIDED|95.0|0.64|3.33|||Regression, Logistic|||at week 36||3.33|0.64|0.367
71147288|NCT03773978|141788231|SUPERIORITY||Odds Ratio (OR)|1.9||||0.162|TWO_SIDED|95.0|0.77|4.67|||Regression, Logistic|||at week 40||4.67|0.77|0.162
71147289|NCT03773978|141788231|SUPERIORITY||Odds Ratio (OR)|1.96||||0.113|TWO_SIDED|95.0|0.85|4.5|||Regression, Logistic|||at week 44||4.50|0.85|0.113
71147290|NCT03773978|141788232|SUPERIORITY||Odds Ratio (OR)|0.8||||0.511|TWO_SIDED|95.0|0.42|1.55|||Regression, Logistic|||at week 16||1.55|0.42|0.511
70955649|NCT03809429|141415017|OTHER||Difference|0.37||||0.2025|TWO_SIDED|95.0|-0.2|0.94|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||Total number of blastocysts||0.94|-0.20|0.2025
71147291|NCT03773978|141788232|SUPERIORITY||Odds Ratio (OR)|1.64||||0.145|TWO_SIDED|95.0|0.84|3.2|||Regression, Logistic|||at week 20||3.20|0.84|0.145
71147292|NCT03773978|141788232|SUPERIORITY||Odds Ratio (OR)|1.38||||0.349|TWO_SIDED|95.0|0.7|2.72|||Regression, Logistic|||at week 24||2.72|0.70|0.349
71147293|NCT03773978|141788232|SUPERIORITY||Odds Ratio (OR)|1.63||||0.167|TWO_SIDED|95.0|0.82|3.25|||Regression, Logistic|||at week 28||3.25|0.82|0.167
71147294|NCT03773978|141788232|SUPERIORITY||Odds Ratio (OR)|1.55||||0.212|TWO_SIDED|95.0|0.78|3.07|||Regression, Logistic|||at week 32||3.07|0.78|0.212
71147295|NCT03773978|141788232|SUPERIORITY||Odds Ratio (OR)|1.21||||0.577|TWO_SIDED|95.0|0.62|2.39|||Regression, Logistic|||at week 36||2.39|0.62|0.577
71147296|NCT03773978|141788232|SUPERIORITY||Odds Ratio (OR)|1.51||||0.225|TWO_SIDED|95.0|0.78|2.95|||Regression, Logistic|||at week 40||2.95|0.78|0.225
71147297|NCT03773978|141788232|SUPERIORITY||Odds Ratio (OR)|1.96||||0.055|TWO_SIDED|95.0|0.98|3.9|||Regression, Logistic|||at week 44||3.90|0.98|0.055
71147298|NCT03773978|141788234|SUPERIORITY||LS Mean difference|-4.33|STANDARD_ERROR_OF_MEAN|1.328||0.001|TWO_SIDED|95.0|-6.95|-1.7|||ANCOVA|||||-1.70|-6.95|0.001
71147299|NCT03773978|141788235|SUPERIORITY||LS Mean difference|-12.97|STANDARD_ERROR_OF_MEAN|4.262||0.003|TWO_SIDED|95.0|-21.39|-4.55|||ANCOVA|||||-4.55|-21.39|0.003
71147300|NCT03773978|141788236|SUPERIORITY||LS Mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.526||0.574|TWO_SIDED|95.0|-2.62|1.91|||ANCOVA|||||1.91|-2.62|0.574
71147301|NCT03773978|141788237|SUPERIORITY||LS Mean difference|0.45|STANDARD_ERROR_OF_MEAN|0.348||0.208|TWO_SIDED|95.0|-0.26|1.15|||ANCOVA|||||1.15|-0.26|0.208
70874830|NCT02345850|141234131|SUPERIORITY|||||||0.227||||||A Bonferroni adjusted significance level of 0.05/3=0.0167 is used for each of three interaction tests to account for multiple testing.|Cox proportional hazards regression|||Subgroup analyses are conducted for CRFS according to disease, disease risk and age. Interaction tests between treatment group and subgroup are conducted within a Cox proportional hazards regression model with treatment, subgroup, and a treatment\*subgroup interaction term. The null hypothesis is that there is no Interaction between treatment group and Disease (AML vs. ALL vs. MDS) for CRFS.||||0.227
70874831|NCT02345850|141234132|SUPERIORITY||Hazard Ratio (HR)|1.744||||0.0197|TWO_SIDED|95.0|1.086|2.8||The OS pairwise comparisons are tested at a Bonferroni adjusted significance level of 0.05/3.|Log Rank|||The null hypothesis is that there is no difference of the OS hazard ratio between CD34 select graft vs. Tac/MTX Control.||2.800|1.086|0.0197
70874832|NCT02345850|141234132|SUPERIORITY||Hazard Ratio (HR)|1.016||||0.9525|TWO_SIDED|95.0|0.599|1.724||The OS pairwise comparisons are tested at a Bonferroni adjusted significance level of 0.05/3.|Log Rank|||The null hypothesis is that there is no difference of the OS hazard ratio between Post-Transplant Cyclophosphamide vs. Tac/MTX Control.||1.724|0.599|0.9525
70874833|NCT02345850|141234132|SUPERIORITY||Hazard Ratio (HR)|1.774||||0.0185|TWO_SIDED|95.0|1.093|2.877||The OS pairwise comparisons are tested at a Bonferroni adjusted significance level of 0.05/3.|Log Rank|||The null hypothesis is that there is no difference of the OS hazard ratio between CD34 select graft vs. Post-Transplant Cyclophosphamide.||2.877|1.093|0.0185
70874834|NCT02345850|141234132|SUPERIORITY|||||||0.026||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the OS hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.026
70955650|NCT03809429|141415017|OTHER||Difference|0.12||||0.5946|TWO_SIDED|95.0|-0.31|0.54|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||Number of good-quality blastocysts||0.54|-0.31|0.5946
71147302|NCT03773978|141788238|SUPERIORITY||LS Mean difference|-1.08|STANDARD_ERROR_OF_MEAN|0.438||0.019|TWO_SIDED|95.0|-1.98|-0.19|||ANCOVA|||||-0.19|-1.98|0.019
71147303|NCT04659863|141788245|OTHER||Mean Difference (Net)|-33.25|||||TWO_SIDED|95.0|-59.17|-7.34||||||||-7.34|-59.17|
71147304|NCT04408989|141788308|EQUIVALENCE|"PK similarity was achieved if the 90% CIs for the biosimilar-to-reference ratios of AUC(0-∞) were within the predefined 0.80-1.25 acceptance similarity criteria.~The PK parameter AUC(0-∞) was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|0.943|||||TWO_SIDED|90.0|0.899|0.989|||||For the comparison, MB02 SP represents the numerator and MB02 DM represents the denominator.|||0.989|0.899|
71147305|NCT04408989|141788308|EQUIVALENCE|"PK similarity was achieved if the 90% CIs for the biosimilar-to-reference ratios of AUC(0-∞) were within the predefined 0.80-1.25 acceptance similarity criteria.~The PK parameter AUC(0-∞) was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|1.0|||||TWO_SIDED|90.0|0.956|1.05|||||For the comparison, MB02 SP represents the numerator and US Avastin represents the denominator.|||1.05|0.956|
70874835|NCT02345850|141234133|SUPERIORITY|||||||0.029||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Log Rank|||The null hypothesis is that there is no difference of Relapse-Free Survival between the treatment groups.||||0.029
70874836|NCT02345850|141234133|SUPERIORITY|||||||0.145||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the RFS hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.145
71147306|NCT04408989|141788308|EQUIVALENCE|"PK similarity was achieved if the 90% CIs for the biosimilar-to-reference ratios of AUC(0-∞) were within the predefined 0.80-1.25 acceptance similarity criteria.~The PK parameter AUC(0-∞) was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|1.07|||||TWO_SIDED|90.0|1.01|1.12|||||For the comparison, MB02 DM represents the numerator and US Avastin represents the denominator.|||1.12|1.01|
70874837|NCT02345850|141234134|SUPERIORITY|||||||0.02||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Transplant-Related Mortality between the treatment groups.||||0.020
70874838|NCT02345850|141234134|SUPERIORITY|||||||0.04||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the TRM hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.040
70874839|NCT02345850|141234135|SUPERIORITY|||||||0.2389||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||The null hypothesis is that there is no difference of immunosuppression-free survival at 1-year post-transplant between the treatment groups.||||0.2389
70874840|NCT02345850|141234135|SUPERIORITY||||||<|0.0001|||||||Cohen's Kappa|||The null hypothesis is that there is no agreement between CRFS and immunosuppression-free survival at 1-year post-transplant.||||<0.0001
70874841|NCT02345850|141234136|SUPERIORITY|||||||0.076||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Disease Relapse between the treatment groups.||||0.076
70874842|NCT02345850|141234136|SUPERIORITY|||||||0.106||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the Disease Relapse hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.106
71147307|NCT04408989|141788309|EQUIVALENCE|"PK similarity was achieved if the 90% CIs for the biosimilar-to-reference ratios of Cmax were within the predefined 0.80-1.25 acceptance similarity criteria.~The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|0.937|||||TWO_SIDED|90.0|0.887|0.989|||||For the comparison, MB02 SP represents the numerator and MB02 DM represents the denominator.|||0.989|0.887|
71147308|NCT04408989|141788309|EQUIVALENCE|"PK similarity was achieved if the 90% CIs for the biosimilar-to-reference ratios of Cmax were within the predefined 0.80-1.25 acceptance similarity criteria.~The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|0.983|||||TWO_SIDED|90.0|0.925|1.05|||||For the comparison, MB02 SP represents the numerator and US Avastin represents the denominator.|||1.05|0.925|
71147309|NCT04408989|141788309|EQUIVALENCE|"PK similarity was achieved if the 90% CIs for the biosimilar-to-reference ratios of Cmax were within the predefined 0.80-1.25 acceptance similarity criteria.~The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|1.05|||||TWO_SIDED|90.0|0.991|1.11|||||For the comparison, MB02 DM represents the numerator and US Avastin represents the denominator.|||1.11|0.991|
71147310|NCT04672239|141788338|SUPERIORITY||Mean Difference (Final Values)|7.3341||||0.0219|TWO_SIDED|95.0|1.0734|13.5948||We used hierarchical linear mixed models with maximum likelihood estimation of all available longitudinal data to handle missing data, then used a planned, pairwise comparison to test for end-of-treatment group differences.|Mixed Models Analysis||Model-estimated difference for the pairwise group difference at week 6 post-quit (end-of-treatment).|This proof-of-concept RCT was powered to detect an effect size of d=0.50 between SiS3 and either of the two control groups. Using SAS PROC POWER, it was determined that a sample size of n=64 per group would be needed to detect this effect in a 2-sided t-test with p=.05. Assuming a retention rate of 85%, it was determined that one needed to enroll n=75 per group in order to retain n=64 by end of treatment.||13.5948|1.0734|0.0219
71147311|NCT04672239|141788338|SUPERIORITY||Mean Difference (Final Values)|8.7775||||0.0072|TWO_SIDED|95.0|2.407|15.148||We used hierarchical linear mixed models with maximum likelihood estimation of all available longitudinal data to handle missing data, then used a planned, pairwise comparison to test for end-of-treatment group differences.|Mixed Models Analysis||Model-estimated difference for the pairwise group difference at week 6 post-quit (end-of-treatment).|This proof-of-concept RCT was powered to detect an effect size of d=0.50 between SiS3 and either of the two control groups. Using SAS PROC POWER, it was determined that a sample size of n=64 per group would be needed to detect this effect in a 2-sided t-test with p=.05. Assuming a retention rate of 85%, it was determined that one needed to enroll n=75 per group in order to retain n=64 by end of treatment.||15.1480|2.4070|0.0072
70874843|NCT02345850|141234137|SUPERIORITY|||||||0.0764||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Neutrophil Engraftment post-transplantation between the treatment groups.||||0.0764
70874844|NCT02345850|141234138|SUPERIORITY|||||||0.0001||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Platelet recovery post-transplantation between the treatment groups.||||0.0001
70874845|NCT02345850|141234140|SUPERIORITY|||||||0.1478|||||||Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Secondary graft failure post-transplantation between the treatment groups.||||0.1478
70874846|NCT02345850|141234141|SUPERIORITY|||||||0.0026||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of grade II-IV acute GVHD post-transplantation between the treatment groups.||||0.0026
70874847|NCT02345850|141234141|SUPERIORITY|||||||0.0369||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of grade III-IV acute GVHD post-transplantation between the treatment groups.||||0.0369
70874848|NCT02345850|141234141|SUPERIORITY|||||||0.002||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the grade II-IV acute GVHD hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.002
70874849|NCT02345850|141234141|SUPERIORITY|||||||0.046||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the grade III-IV acute GVHD hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.046
70955651|NCT03809429|141415023|OTHER||Difference|16.94|||<|0.0001|TWO_SIDED|95.0|12.13|21.74|||ANOVA|ANOVA model with treatment, age strata, and AMH group as factors.||||21.74|12.13|<0.0001
70874850|NCT02345850|141234143|SUPERIORITY|||||||0.0024||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of chronic GVHD post-transplantation between the treatment groups.||||0.0024
70874851|NCT02345850|141234143|SUPERIORITY|||||||0.005||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the chronic GVHD hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.005
70874852|NCT02345850|141234144|SUPERIORITY|||||||0.229||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Log Rank|||The null hypothesis is that there is no difference of Chronic GVHD-free Survival post-transplantation between the treatment groups.||||0.229
70874853|NCT02345850|141234146|SUPERIORITY|||||||0.0006||||||Superiority - Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Grades II-III infection post-transplantation between the treatment groups.||||0.0006
70955652|NCT03809429|141415024|OTHER||Difference|1.56|||<|0.0001|TWO_SIDED|95.0|1.19|1.92|||ANOVA|ANOVA model with treatment, age strata, and AMH group as factors.||||1.92|1.19|<0.0001
70955653|NCT03809429|141415025|OTHER||Difference|6.99||||0.1579|TWO_SIDED|95.0|-2.71|16.7|||Regression, Logistic|Logistic regression model with treatment, age strata, and AMH group as factors.||||16.70|-2.71|0.1579
70955654|NCT03809429|141415027|OTHER||Difference|7.66||||0.1134|TWO_SIDED|95.0|-1.82|17.14|||Regression, Logistic|Logistic regression model with treatment, age strata, and AMH group as factors.||||17.14|-1.82|0.1134
70955655|NCT03809429|141415028|OTHER||Difference|8.81||||0.0642|TWO_SIDED|95.0|-0.52|18.14|||Regression, Logistic|Logistic regression model with treatment, age strata, and AMH group as factors.||||18.14|-0.52|0.0642
70955656|NCT03809429|141415029|OTHER||Difference|7.74||||0.1002|TWO_SIDED|95.0|-1.49|16.97|||Regression, Logistic|Logistic regression model with treatment, age strata, and AMH group as factors.||||16.97|-1.49|0.1002
70955657|NCT03507777|141415039|SUPERIORITY||||||<|0.0001|||||||Linear mixed model|||||||<0.0001
70955658|NCT03507777|141415040|SUPERIORITY|||||||0.2487|||||||A Cox regression model|||||||0.2487
70955659|NCT03507777|141415041|SUPERIORITY|||||||0.2952|||||||A Cox regression model|||||||0.2952
70874854|NCT02345850|141234146|SUPERIORITY|||||||0.0145||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Grades III infection post-transplantation between the treatment groups.||||0.0145
70874855|NCT01991067|141234155|OTHER|Furthermore, a multivariable logistic regression model was applied accounting for group as well as age, body mass index, and gender as possible influence factors.|||||<|0.001||||||The threshold for statistical significance was a p-value of \<0.05.|Fisher Exact|||The calculation of the sample size was performed using nQuery 6.1. The primary endpoint was the outcome of the NT 4 weeks after the second vaccination. A Fisher exact tes was calculated to analyze the primary hypothesis on the difference in NT-titer response between patients and controls||||<0.001
70874856|NCT01991067|141234156|OTHER|||||||0.02|||||||Fisher Exact|||A Fisher exact test was calculated to analyze antibody response by ELISA between patients and controls. To measure the Agreement between the NT and ELISA response, Cohens Kappa and the corresponding 95% confidence interval were calculated||||0.02
70874857|NCT01991067|141234157|OTHER||||||<|0.01|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||"For titer values the geometric mean was calculated and the corresponding two-sided 95% confidence intervals were constructed by back-transfomration of the CI for the mean of the logarithmically transformed results.~To investigate the difference in absolute titer values and geometric mean fold changes between time point and Groups, Wilcoxon tests were performed."||||<0.01
70955660|NCT04797650|141415050|SUPERIORITY||Risk Difference (RD)|0.31|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001|TWO_SIDED|95.0|0.25|0.37||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.37|0.25|<0.0001
70874858|NCT01075204|141234166|SUPERIORITY_OR_OTHER|||||||0.334||95.0|||||Chi-squared|9 degrees of freedom.||Logistic regression: Omnibus Test of Model Coefficients (all the nine variables are considered together).||||0.334
70955661|NCT04797650|141415050|SUPERIORITY||Risk Difference (RD)|0.36|STANDARD_ERROR_OF_MEAN|0.044|<|0.0001|TWO_SIDED|95.0|0.27|0.45||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.45|0.27|<0.0001
70955662|NCT04797650|141415051|SUPERIORITY||Risk Difference (RD)|0.38|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.31|0.46||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.46|0.31|<0.0001
70955663|NCT04797650|141415051|SUPERIORITY||Risk Difference (RD)|0.36|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001|TWO_SIDED|95.0|0.26|0.45||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.45|0.26|<0.0001
70955664|NCT04797650|141415051|SUPERIORITY||Risk Difference (RD)|0.37|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|0.3|0.45||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.45|0.30|<0.0001
70874859|NCT01752907|141234184|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.3|STANDARD_ERROR_OF_MEAN|0.4||0.3479|TWO_SIDED|95.0|-0.4|1.0|||t-test, 2 sided||Treatment difference = bone pain DVD - general education DVD|There was no statistical hypothesis testing for this study. The clinical hypothesis was that a difference in mean maximum pain of 0.5 (scale 0 to 10) in favor of bone pain education would be a clinically relevant difference.||1.0|-0.4|0.3479
70874860|NCT02670083|141234195|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.354|||TWO_SIDED|95.0|-0.86|0.53||||||||0.53|-0.86|
70874861|NCT02670083|141234196|SUPERIORITY||Least Squares Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|1.083|||TWO_SIDED|95.0|-2.39|1.87||||||||1.87|-2.39|
70874862|NCT02670083|141234197|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.006|||TWO_SIDED|95.0|-2.08|1.88||||||||1.88|-2.08|
70874863|NCT02670083|141234198|SUPERIORITY||Least Squares Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.076|||TWO_SIDED|95.0|-0.1|0.2||||||||0.20|-0.10|
70955665|NCT04797650|141415051|SUPERIORITY||Risk Difference (RD)|0.4|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001|TWO_SIDED|95.0|0.31|0.5||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.50|0.31|<0.0001
70955666|NCT04797650|141415051|SUPERIORITY||Risk Difference (RD)|0.39|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.32|0.46||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.46|0.32|<0.0001
70955667|NCT04797650|141415051|SUPERIORITY||Risk Difference (RD)|0.5|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001|TWO_SIDED|95.0|0.41|0.59||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.59|0.41|<0.0001
70955668|NCT04797650|141415051|SUPERIORITY||Risk Difference (RD)|0.45|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|0.38|0.52||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.52|0.38|<0.0001
70955669|NCT04797650|141415051|SUPERIORITY||Risk Difference (RD)|0.49|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001|TWO_SIDED|95.0|0.4|0.58||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.58|0.40|<0.0001
70955670|NCT04797650|141415052|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|0.004||0.3175|TWO_SIDED|95.0|0.0|0.01||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 4||0.01|-0.00|0.3175
70955671|NCT04797650|141415052|SUPERIORITY||Risk Difference (RD)|0.02|STANDARD_ERROR_OF_MEAN|0.013||0.102|TWO_SIDED|95.0|0.0|0.05||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 8||0.05|-0.00|0.1020
70955672|NCT04797650|141415052|SUPERIORITY||Risk Difference (RD)|0.02|STANDARD_ERROR_OF_MEAN|0.016||0.3103|TWO_SIDED|95.0|-0.01|0.05||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 8||0.05|-0.01|0.3103
70955673|NCT04797650|141415052|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001|TWO_SIDED|95.0|0.06|0.14||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.14|0.06|<0.0001
70955674|NCT04797650|141415052|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.06|0.17||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.17|0.06|<0.0001
70955675|NCT04797650|141415052|SUPERIORITY||Risk Difference (RD)|0.19|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.14|0.24||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.24|0.14|<0.0001
70874864|NCT02670083|141234199|SUPERIORITY||Least Squares Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.486|||TWO_SIDED|95.0|-0.62|1.29||||||||1.29|-0.62|
70874865|NCT02670083|141234200|SUPERIORITY||Least Squares Mean Difference|1.88|STANDARD_ERROR_OF_MEAN|1.679|||TWO_SIDED|95.0|-1.43|5.18||||||||5.18|-1.43|
70955676|NCT04797650|141415052|SUPERIORITY||Risk Difference (RD)|0.2|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|0.13|0.27||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.27|0.13|<0.0001
70955677|NCT04797650|141415052|SUPERIORITY||Risk Difference (RD)|0.23|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.18|0.29||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo|Mantel Haenszel|||Week 20||0.29|0.18|<0.0001
70955678|NCT04797650|141415052|SUPERIORITY||Risk Difference (RD)|0.27|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.19|0.35||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.35|0.19|<0.0001
70955679|NCT04797650|141415053|SUPERIORITY||Least Square (LS) Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.97||0.0039|TWO_SIDED|95.0|-4.7|-0.9||P-value was calculated by mixed model repeated measures (MMRM) analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 4||-0.9|-4.7|0.0039
70955680|NCT04797650|141415053|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.12||0.0027|TWO_SIDED|95.0|-5.6|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 4||-1.2|-5.6|0.0027
70955681|NCT04797650|141415053|SUPERIORITY||LS Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|2.15|<|0.0001|TWO_SIDED|95.0|-13.6|-5.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 8||-5.1|-13.6|<0.0001
70955682|NCT04797650|141415053|SUPERIORITY||LS Mean Difference|-14.2|STANDARD_ERROR_OF_MEAN|2.47|<|0.0001|TWO_SIDED|95.0|-19.0|-9.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 8||-9.3|-19|<0.0001
70874866|NCT02670083|141234201|SUPERIORITY||Least Squares Mean Difference|1.22|STANDARD_ERROR_OF_MEAN|1.306|||TWO_SIDED|95.0|-1.35|3.79||||||||3.79|-1.35|
70874867|NCT02670083|141234203|SUPERIORITY||Least Squares Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.723|||TWO_SIDED|95.0|-1.95|0.9||||||||0.90|-1.95|
70874868|NCT02670083|141234204|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.609|||TWO_SIDED|95.0|-0.81|1.6||||||||1.60|-0.81|
70874869|NCT02670083|141234205|SUPERIORITY||Least Squares Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|6.214|||TWO_SIDED|95.0|-13.64|10.86||||||||10.86|-13.64|
70874870|NCT02670083|141234206|SUPERIORITY||Least Squares Mean Difference|1.82|STANDARD_ERROR_OF_MEAN|2.26|||TWO_SIDED|95.0|-2.64|6.27||||||||6.27|-2.64|
70874871|NCT02670083|141234207|SUPERIORITY||Least Squares Mean Difference|0.94|STANDARD_ERROR_OF_MEAN|2.222|||TWO_SIDED|95.0|-3.45|5.32||||||||5.32|-3.45|
70874872|NCT02670083|141234213|SUPERIORITY||Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.24|0.22||||||||0.22|-0.24|
70874873|NCT02670083|141234214|SUPERIORITY||Least Squares Mean Difference|-1.28|STANDARD_ERROR_OF_MEAN|1.245|||TWO_SIDED|95.0|-3.72|1.17||||||||1.17|-3.72|
70874874|NCT02670083|141234215|SUPERIORITY||Least Squares Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.253|||TWO_SIDED|95.0|-0.1|0.89||||||||0.89|-0.10|
70874875|NCT02014597|141234217|OTHER|||||||0.0583||||||Scotopic logCS|Kruskal-Wallis|||||||0.0583
70874876|NCT02014597|141234217|OTHER|||||||0.1762||||||Photopic logCS|Kruskal-Wallis|||||||0.1762
70874877|NCT02014597|141234218|OTHER|||||||0.183||||||Scotopic|Pearson correlation|||Correlation between logCS and MD.||||0.183
70874878|NCT02014597|141234218|OTHER|||||||0.771||||||Photopic|Pearson correlation|||Correlation between logCS and MD.||||0.771
70874879|NCT02014597|141234218|OTHER|||||||0.492||||||Scotopic|Pearson correlation|||Correlation between logCS and PSD.||||0.492
70874880|NCT02014597|141234218|OTHER|||||||0.83||||||Photopic|Pearson correlation|||Correlation between logCS and PSD.||||0.830
70874881|NCT02425046|141234238|SUPERIORITY|||||||0.67||||||Threshold for statistical significance \<0.05|t-test, 2 sided|Multiple imputation used to fill in missing data - imputation included demographic and 6 month data. 5 datasets created and results averaged.||||||0.67
70874882|NCT02425046|141234239|SUPERIORITY|||||||0.735|||||||t-test, 2 sided|Multiple imputation used to fill in missing data - imputation included demographic and 6 month data. 5 datasets created and results averaged.||null hypothesis - there will be no difference between the groups.||||0.735
70874883|NCT02425046|141234240|SUPERIORITY|||||||0.599|||||||t-test, 2 sided|Multiple imputation used to fill in missing data - imputation included demographic and 6 month data. 5 datasets created and results averaged.||Null hypothesis that there would be no difference in change in FNPA scores between the two groups over 12 months.||||0.599
70874884|NCT02425046|141234241|SUPERIORITY|||||||0.583|||||||t-test, 2 sided|Multiple imputation used to fill in missing data - imputation included demographic and 6 month data. 5 datasets created and results averaged.||Null hypothesis: Change in MVPA from baseline to 12 months will not be different between target children in the two groups.||||0.583
70874885|NCT02425046|141234242|SUPERIORITY|||||||0.312|||||||t-test, 2 sided|Multiple imputation including demographics and 6 month data used to complete dataset. 5 datasets created and t-score averaged.||Null hypothesis is that there will be no difference between the two arms in change in sugar sweetened beverage intake over 12 months.||||0.312
70874886|NCT02425046|141234243|SUPERIORITY||difference in change between two arms|75.0||||0.1|TWO_SIDED|95.0|-15.0|165.0|||Linear quantile mixed model|Linear quantile mixed models (a non-parametric linear mixed model) was used because of non-normal distribution that could not be transformed.|Comparison of the intervention target adult change in reported physical activity compared to the control group.|Linear quantile mixed models (a non-parametric linear mixed model) was used because because of non-normal distribution that could not be remedied by transformation.||165|-15|0.10
70874887|NCT02425046|141234244|SUPERIORITY||difference in change between two arms|-2.54||||0.057|TWO_SIDED|95.0|-5.14|0.07|||Mixed Models Analysis||The intervention arm in comparison to the control arm.|||0.07|-5.14|0.057
70874888|NCT02425046|141234245|SUPERIORITY|||||||0.874|||||||t-test, 2 sided|Multiple imputation including demographics and 6 month data used to complete dataset. 5 datasets created and t-score averaged.||||||0.874
70874889|NCT02425046|141234246|SUPERIORITY||% difference in change between arms|7.0||||0.31|TWO_SIDED|95.0|-7.0|23.0|||Mixed Models Analysis|Screen time was log transformed to normalized the distribution. Results have been back transformed from log 10 scale.|% change in screen time of the intervention arm compared to the control arm.|||23|-7|0.31
70874890|NCT02425046|141234247|SUPERIORITY|||||||0.516|||||||t-test, 2 sided|Multiple imputation including demographics and 6 month data used to complete dataset. 5 datasets created and t-score averaged.||||||0.516
70874891|NCT02692716|141234256|NON_INFERIORITY|This hypothesis was controlled for multiplicity. Non-inferiority of oral semaglutide versus placebo was considered confirmed if the upper limit of the two-sided 95% confidence interval for the HR was strictly below 1.8.|Hazard Ratio (HR)|0.79|||<|0.0001|TWO_SIDED|95.0|0.57|1.11||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority).|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first event adjudication committee (EAC) confirmed MACE was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.11|0.57|< 0.0001
70874892|NCT02692716|141234256|SUPERIORITY|This hypothesis was controlled for multiplicity.|Hazard Ratio (HR)|0.79|||=|0.1749|TWO_SIDED|95.0|0.57|1.11||Unadjusted two-sided p-value from test of no difference from 1 (superiority).|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed MACE was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.11|0.57|= 0.1749
70874893|NCT02692716|141234257|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.82|||=|0.1827|TWO_SIDED|95.0|0.61|1.1||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed expanded cardiovascular outcome was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.10|0.61|= 0.1827
71147312|NCT04672239|141788339|SUPERIORITY||Odds Ratio (OR)|1.5072||||0.2259|TWO_SIDED|95.0|0.7759|2.9281|||Generalized Linear Model|We used a Generalized Linear Model with binomial distribution (abstinent vs. smoking) and logit link with repeated measures over time.|The odds ratio compares the SiS app treatment to the QG app treatment at week 6 post-quit (end-of-treatment).|This was an exploratory aim, so no power analysis was conducted. We hypothesized, that the 30-day point prevalence smoking cessation prevalence would be higher in the SiS app treatment compared to the QuitGuide app treatment. Participants with missing data were assumed to be smoking. We modeled all available data over time and present the cross-sectional group difference test at week 6 post quit (i.e., end-of-treatment).||2.9281|0.7759|0.2259
71147313|NCT04672239|141788339|SUPERIORITY||Odds Ratio (OR)|1.963||||0.0579|TWO_SIDED|95.0|0.9776|3.9415|||Generalized Linear Model|We used a Generalized Linear Model with binomial distribution (abstinent vs. smoking) and logit link with repeated measures over time.|The odds ratio compares the SiS app treatment to the CtA pamphlet at week 6 post-quit (end-of-treatment).|This was an exploratory aim, so no power analysis was conducted. We hypothesized, that the 30-day point prevalence smoking cessation prevalence would be higher in the SiS app treatment compared to the Clearing the Air pamphlet treatment. Participants with missing data were assumed to be smoking. We modeled all available data over time and present the cross-sectional group difference test at week 6 post quit (i.e., post-treatment).||3.9415|0.9776|0.0579
71147314|NCT04672239|141788340|SUPERIORITY||Wilcoxon Z|0.401||||0.9152|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Pairwise Two-Sided Multiple Comparison Analysis Dwass, Steel, Critchlow-Fligner Method|SiS app treatment vs. QuitGuide app treatment at week 6 post-quit (end-of-treatment)|||||0.9152
71147315|NCT04672239|141788340|SUPERIORITY||Wilcoxon Z|1.372||||0.3557|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Pairwise Two-Sided Multiple Comparison Analysis Dwass, Steel, Critchlow-Fligner Method|Pairwise comparison, SiS app treatment vs. CTA pamphlet at week 6 post-quit (end-of-treatment)|||||0.3557
71147316|NCT04672239|141788341|SUPERIORITY||Mean Difference (Final Values)|0.2936||||0.7469|TWO_SIDED|95.0|-1.4983|2.0856||The p-value was not adjusted for multiple comparisons.|t-test, 2 sided||Comparison of SiS app treatment to the QuitGuide treatment as control (Contrast coding SiS 1, QG -1)|||2.0856|-1.4983|0.7469
70874894|NCT02692716|141234258|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.49|||=|0.0261|TWO_SIDED|95.0|0.27|0.92||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed cardiovascular death (including undetermined cause of death) was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||0.92|0.27|= 0.0261
70955683|NCT04797650|141415053|SUPERIORITY||LS Mean Difference|-23.0|STANDARD_ERROR_OF_MEAN|2.92|<|0.0001|TWO_SIDED|95.0|-28.8|-17.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-17.3|-28.8|<0.0001
71147317|NCT04672239|141788341|SUPERIORITY||Mean Difference (Final Values)|1.2569||||0.1747|TWO_SIDED|95.0|-0.5628|3.0766||The p-value was not adjusted for multiple comparisons.|t-test, 2 sided||Comparison of SiS app treatment to the Clearing the Air pamphlet treatment as control (Contrast coding SiS 1, CtA -1)|||3.0766|-0.5628|0.1747
71147318|NCT04672239|141788342|SUPERIORITY||Wilcoxon Z|1.9255||||0.1315|TWO_SIDED|||||p-values were not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|Pairwise Two-Sided Multiple Comparison Analysis Dwass, Steel, Critchlow-Fligner Method||||||0.1315
71147319|NCT04672239|141788342|SUPERIORITY||Wilcoxon Z|1.401||||0.3403|TWO_SIDED|||||the p-value was not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|Pairwise Two-Sided Multiple Comparison Analysis Dwass, Steel, Critchlow-Fligner Method|SiS app vs. Clearing the Air pamphlet|||||0.3403
71147320|NCT04672239|141788343|SUPERIORITY||Mean Difference (Final Values)|0.2289||||0.0429|TWO_SIDED|95.0|0.007364|0.4505||p-value is not adjusted for multiple comparisons|t-test, 2 sided||||SiS app vs. QuitGuide app|0.4505|0.007364|0.0429
71147321|NCT04672239|141788343|SUPERIORITY||Mean Difference (Final Values)|0.1609||||0.16|TWO_SIDED|95.0|-0.06415|0.386||p-value is not adjusted for multiple comparisons|t-test, 2 sided||||SiS app vs. CtA pamphlet|0.3860|-0.06415|0.1600
71147322|NCT04672239|141788344|SUPERIORITY||Mean Difference (Final Values)|0.152||||0.1996|TWO_SIDED|95.0|-0.08092|0.3848||p-value is not adjusted for multiple comparisons|t-test, 2 sided||||SiS app vs. QG app|0.3848|-0.08092|0.1996
71147323|NCT04672239|141788344|SUPERIORITY||Mean Difference (Final Values)|0.292||||0.0154|TWO_SIDED|95.0|0.05636|0.5276||p-value was not adjusted for multiple comparisons|t-test, 2 sided||||SiS app vs. CtA pamphlet (control)|0.5276|0.05636|0.0154
71147324|NCT04672239|141788345|SUPERIORITY||Mean Difference (Final Values)|2.6255||||0.2988|TWO_SIDED|95.0|-2.3458|7.5968||p-value was not adjusted for multiple comparisons|t-test, 2 sided||||SiS app vs. QuitGuide app (control)|7.5968|-2.3458|0.2988
71147325|NCT04672239|141788345|SUPERIORITY||Mean Difference (Final Values)|3.9277||||0.1251|TWO_SIDED|95.0|-1.1015|8.9569||p-value was not adjusted for multiple comparisons|t-test, 2 sided||||SiS app vs. CtA pamphlet (control)|8.9569|-1.1015|0.1251
71147326|NCT04672239|141788346|SUPERIORITY||Wilcoxon Z|-0.8096||||0.4182|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.4182
71147327|NCT04672239|141788347|SUPERIORITY||Wilcoxon Z|1.909||||0.0563|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0563
71147328|NCT04672239|141788348|SUPERIORITY||Mean Difference (Final Values)|0.1106||||0.5018|TWO_SIDED|95.0|-0.2143|0.4354|||t-test, 2 sided|||||0.4354|-0.2143|0.5018
71147329|NCT04672239|141788349|SUPERIORITY||Mean Difference (Final Values)|0.1406||||0.4246|TWO_SIDED|95.0|-0.2068|0.488|||t-test, 2 sided|||||0.4880|-0.2068|0.4246
71147330|NCT04672239|141788350|SUPERIORITY||Mean Difference (Final Values)|2.4296||||0.4078|TWO_SIDED|95.0|-3.3597|8.2188|||t-test, 2 sided||SiS app vs. QG (control)|||8.2188|-3.3597|0.4078
71147331|NCT05565742|141788402|SUPERIORITY||LS Mean difference (Final Values)|-40.8|STANDARD_ERROR_OF_MEAN|8.82|<|0.001|TWO_SIDED|95.0|-55.8|-20.6|||Mixed Models Analysis|||||-20.6|-55.8|<0.001
71147332|NCT05565742|141788402|SUPERIORITY||LS Mean difference (Final Values)|-75.2|STANDARD_ERROR_OF_MEAN|3.01|<|0.001|TWO_SIDED|95.0|-80.4|-68.5|||Mixed Models Analysis|||||-68.5|-80.4|<0.001
71147333|NCT05565742|141788402|SUPERIORITY||LS Mean difference (Final Values)|-93.9|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|-95.1|-92.5|||Mixed Models Analysis|||||-92.5|-95.1|<0.001
71147334|NCT05565742|141788403|SUPERIORITY||LS Mean difference (Final Values)|-38.9|STANDARD_ERROR_OF_MEAN|9.43||0.002|TWO_SIDED|95.0|-54.9|-17.2|||Mixed Models Analysis|||||-17.2|-54.9|0.002
71147335|NCT05565742|141788403|SUPERIORITY||LS Mean difference (Final Values)|-77.4|STANDARD_ERROR_OF_MEAN|2.83|<|0.001|TWO_SIDED|95.0|-82.4|-71.1|||Mixed Models Analysis|||||-71.1|-82.4|<0.001
71147336|NCT05565742|141788403|SUPERIORITY||LS Mean difference (Final Values)|-95.0|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-96.1|-93.6|||Mixed Models Analysis|||||-93.6|-96.1|<0.001
71147337|NCT05565742|141788403|SUPERIORITY||LS Mean difference (Final Values)|-76.8|STANDARD_ERROR_OF_MEAN|2.94|<|0.001|TWO_SIDED|95.0|-81.9|-70.2|||Mixed Models Analysis|||||-70.2|-81.9|<0.001
71147338|NCT05565742|141788404|SUPERIORITY||Odds Ratio (OR)|112.03||||0.001|TWO_SIDED|95.0|6.35|1975.13|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 60||1975.13|6.35|0.001
71147339|NCT05565742|141788404|SUPERIORITY||Odds Ratio (OR)|2762.52|||<|0.001|TWO_SIDED|95.0|142.74|53463.34|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 60||53463.34|142.74|<0.001
71147340|NCT05565742|141788404|SUPERIORITY||Odds Ratio (OR)|50904.09|||<|0.001|TWO_SIDED|95.0|1700.95|1523398.1|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 60||1523398.10|1700.95|<0.001
71147341|NCT05565742|141788404|SUPERIORITY||Odds Ratio (OR)|27.94||||0.026|TWO_SIDED|95.0|1.48|527.74|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 180||527.74|1.48|0.026
71147342|NCT05565742|141788404|SUPERIORITY||Odds Ratio (OR)|309.36|||<|0.001|TWO_SIDED|95.0|17.99|5320.81|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 180||5320.81|17.99|<0.001
71147343|NCT05565742|141788404|SUPERIORITY||Odds Ratio (OR)|3060.16|||<|0.001|TWO_SIDED|95.0|166.84|56127.55|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 180||56127.55|166.84|<0.001
71147344|NCT05565742|141788404|SUPERIORITY||Odds Ratio (OR)|32.91||||0.021|TWO_SIDED|95.0|1.7|635.94|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 60||635.94|1.70|0.021
71147345|NCT05565742|141788404|SUPERIORITY||Odds Ratio (OR)|579.62|||<|0.001|TWO_SIDED|95.0|31.48|10673.41|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 60||10673.41|31.48|<0.001
71147346|NCT05565742|141788404|SUPERIORITY||Odds Ratio (OR)|14659.81|||<|0.001|TWO_SIDED|95.0|646.35|332498.98|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 60||332498.98|646.35|<0.001
71147347|NCT05565742|141788404|SUPERIORITY||Odds Ratio (OR)|15.94||||0.071|TWO_SIDED|95.0|0.79|321.21|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 180||321.21|0.79|0.071
71147348|NCT05565742|141788404|SUPERIORITY||Odds Ratio (OR)|86.32||||0.002|TWO_SIDED|95.0|5.07|1468.36|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 180||1468.36|5.07|0.002
70955684|NCT04797650|141415053|SUPERIORITY||LS Mean Difference|-29.3|STANDARD_ERROR_OF_MEAN|3.36|<|0.0001|TWO_SIDED|95.0|-35.9|-22.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-22.7|-35.9|< 0.0001
70955685|NCT04797650|141415053|SUPERIORITY||LS Mean Difference|-34.8|STANDARD_ERROR_OF_MEAN|3.37|<|0.0001|TWO_SIDED|95.0|-41.4|-28.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-28.2|-41.4|< 0.0001
70955686|NCT04797650|141415053|SUPERIORITY||LS Mean Difference|-40.2|STANDARD_ERROR_OF_MEAN|3.86|<|0.0001|TWO_SIDED|95.0|-47.8|-32.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-32.6|-47.8|< 0.0001
70955687|NCT04797650|141415053|SUPERIORITY||LS Mean Difference|-38.7|STANDARD_ERROR_OF_MEAN|3.63|<|0.0001|TWO_SIDED|95.0|-45.9|-31.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-31.6|-45.9|< 0.0001
70955688|NCT04797650|141415053|SUPERIORITY||LS Mean Difference|-46.6|STANDARD_ERROR_OF_MEAN|4.17|<|0.0001|TWO_SIDED|95.0|-54.8|-38.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-38.4|-54.8|< 0.0001
70955689|NCT04797650|141415053|SUPERIORITY||LS Mean Difference|-45.9|STANDARD_ERROR_OF_MEAN|3.8|<|0.0001|TWO_SIDED|95.0|-53.4|-38.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-38.5|-53.4|< 0.0001
70955690|NCT04797650|141415053|SUPERIORITY||LS Mean Difference|-52.8|STANDARD_ERROR_OF_MEAN|4.36|<|0.0001|TWO_SIDED|95.0|-61.4|-44.2|||MMRM|||Week 24||-44.2|-61.4|< 0.0001
70955691|NCT04797650|141415054|SUPERIORITY||||||<|0.0001||||||P-value was calculated by cochran mantel haenszel (CMH) test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||< 0.0001
70955692|NCT04797650|141415054|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||< 0.0001
70955693|NCT04797650|141415054|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||< 0.0001
71147349|NCT05565742|141788404|SUPERIORITY||Odds Ratio (OR)|956.84|||<|0.001|TWO_SIDED|95.0|55.75|16422.76|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 180||16422.76|55.75|<0.001
70955694|NCT04797650|141415054|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||< 0.0001
70955695|NCT04797650|141415054|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo|Cochran-Mantel-Haenszel|||Week 20||||< 0.0001
70955696|NCT04797650|141415054|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||< 0.0001
70955697|NCT04797650|141415054|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||< 0.0001
71147350|NCT05565742|141788405|SUPERIORITY||Odds Ratio (OR)|32.05|||<|0.001|TWO_SIDED|95.0|5.36|191.58|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 240||191.58|5.36|<0.001
71147351|NCT05565742|141788405|SUPERIORITY||Odds Ratio (OR)|602.39|||<|0.001|TWO_SIDED|95.0|95.36|3805.22|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 240||3805.22|95.36|<0.001
70955698|NCT04797650|141415054|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||< 0.0001
70955699|NCT04797650|141415055|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||< 0.0001
71147352|NCT05565742|141788405|SUPERIORITY||Odds Ratio (OR)|6953.37|||<|0.001|TWO_SIDED|95.0|527.56|91646.24|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 240||91646.24|527.56|<0.001
70955700|NCT04797650|141415055|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||< 0.0001
70955701|NCT04797650|141415055|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||< 0.0001
70955702|NCT04797650|141415055|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||< 0.0001
70955703|NCT04797650|141415055|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||< 0.0001
70955704|NCT04797650|141415055|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||< 0.0001
70955705|NCT04797650|141415055|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||< 0.0001
71147353|NCT05565742|141788405|SUPERIORITY||Odds Ratio (OR)|347.76|||<|0.001|TWO_SIDED|95.0|57.46|2104.62|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 240||2104.62|57.46|<0.001
71147354|NCT05565742|141788405|SUPERIORITY||Odds Ratio (OR)|54.99||||0.007|TWO_SIDED|95.0|2.98|1015.84|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 360||1015.84|2.98|0.007
70874895|NCT02692716|141234258|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.18|||=|0.5044|TWO_SIDED|95.0|0.73|1.9||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed non-fatal myocardial infarction was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.90|0.73|= 0.5044
70874896|NCT02692716|141234258|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.74|||=|0.435|TWO_SIDED|95.0|0.35|1.57||Unadjusted two-sided p-value for test of no difference from 1|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed non-fatal stroke was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.57|0.35|= 0.4350
71147355|NCT05565742|141788405|SUPERIORITY||Odds Ratio (OR)|363.15|||<|0.001|TWO_SIDED|95.0|20.83|6332.68|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 360||6332.68|20.83|<0.001
70874897|NCT02692716|141234258|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.56|||=|0.3605|TWO_SIDED|95.0|0.6|4.01||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed unstable angina pectoris requiring hospitalisation was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||4.01|0.60|= 0.3605
71147356|NCT05565742|141788405|SUPERIORITY||Odds Ratio (OR)|2953.53|||<|0.001|TWO_SIDED|95.0|150.95|57790.71|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 360||57790.71|150.95|<0.001
71147357|NCT05565742|141788405|SUPERIORITY||Odds Ratio (OR)|375.16|||<|0.001|TWO_SIDED|95.0|21.46|6571.66|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 360||6571.66|21.46|<0.001
71147358|NCT05565742|141788405|SUPERIORITY||Odds Ratio (OR)|16.43||||0.068|TWO_SIDED|95.0|0.81|331.69|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 540||331.69|0.81|0.068
70955706|NCT04797650|141415055|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||< 0.0001
71147359|NCT05565742|141788405|SUPERIORITY||Odds Ratio (OR)|84.97||||0.002|TWO_SIDED|95.0|4.99|1447.48|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 540||1447.48|4.99|0.002
71147360|NCT05565742|141788405|SUPERIORITY||Odds Ratio (OR)|594.66|||<|0.001|TWO_SIDED|95.0|33.99|10405.09|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 540||10405.09|33.99|<0.001
71147361|NCT05565742|141788405|SUPERIORITY||Odds Ratio (OR)|110.17||||0.001|TWO_SIDED|95.0|6.47|1875.77|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 540||1875.77|6.47|0.001
71147362|NCT05565742|141788405|SUPERIORITY||Odds Ratio (OR)|11.61||||0.01|TWO_SIDED|95.0|1.81|74.29|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 240||74.29|1.81|0.010
71147363|NCT05565742|141788405|SUPERIORITY||Odds Ratio (OR)|233.25|||<|0.001|TWO_SIDED|95.0|39.92|1362.79|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 240||1362.79|39.92|<0.001
71147364|NCT05565742|141788405|SUPERIORITY||Odds Ratio (OR)|3087.58|||<|0.001|TWO_SIDED|95.0|331.26|28778.1|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 240||28778.10|331.26|<0.001
71147365|NCT05565742|141788405|SUPERIORITY||Odds Ratio (OR)|144.58|||<|0.001|TWO_SIDED|95.0|25.2|829.42|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 240||829.42|25.20|<0.001
70874898|NCT02692716|141234258|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.86|||=|0.6227|TWO_SIDED|95.0|0.48|1.55||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed hospitalisation for heart failure was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.55|0.48|= 0.6227
71147366|NCT05565742|141788405|SUPERIORITY||Odds Ratio (OR)|11.16||||0.125|TWO_SIDED|95.0|0.51|243.85|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 360||243.85|0.51|0.125
71147367|NCT05565742|141788405|SUPERIORITY||Odds Ratio (OR)|148.3|||<|0.001|TWO_SIDED|95.0|8.64|2546.89|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 360||2546.89|8.64|<0.001
71147368|NCT05565742|141788405|SUPERIORITY||Odds Ratio (OR)|1431.38|||<|0.001|TWO_SIDED|95.0|77.76|26349.86|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 360||26349.86|77.76|<0.001
71147369|NCT05565742|141788405|SUPERIORITY||Odds Ratio (OR)|147.78|||<|0.001|TWO_SIDED|95.0|8.6|2538.95|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 360||2538.95|8.60|<0.001
71147370|NCT05565742|141788405|SUPERIORITY||Odds Ratio (OR)|1.99||||0.733|TWO_SIDED|95.0|0.04|104.02|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 540||104.02|0.04|0.733
70955707|NCT04797650|141415056|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-1|-1.5|< 0.0001
70955708|NCT04797650|141415056|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.7|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-1.1|-1.7|< 0.0001
71147371|NCT05565742|141788405|SUPERIORITY||Odds Ratio (OR)|34.28||||0.015|TWO_SIDED|95.0|1.98|594.46|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 540||594.46|1.98|0.015
71147372|NCT05565742|141788405|SUPERIORITY||Odds Ratio (OR)|159.77|||<|0.001|TWO_SIDED|95.0|9.4|2716.42|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 540||2716.42|9.40|<0.001
71147373|NCT05565742|141788405|SUPERIORITY||Odds Ratio (OR)|37.98||||0.013|TWO_SIDED|95.0|2.19|659.75|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 540||659.75|2.19|0.013
71147374|NCT05565742|141788406|SUPERIORITY||LS Mean difference (Final Values)|-47.4|STANDARD_ERROR_OF_MEAN|7.29|<|0.001|TWO_SIDED|95.0|-59.9|-30.9|||Mixed Models Analysis|||Baseline to Day 60||-30.9|-59.9|<0.001
71147375|NCT05565742|141788406|SUPERIORITY||LS Mean difference (Final Values)|-80.9|STANDARD_ERROR_OF_MEAN|2.16|<|0.001|TWO_SIDED|95.0|-84.7|-76.1|||Mixed Models Analysis|||Baseline to Day 60||-76.1|-84.7|<0.001
71147376|NCT05565742|141788406|SUPERIORITY||LS Mean difference (Final Values)|-95.5|STANDARD_ERROR_OF_MEAN|0.45|<|0.001|TWO_SIDED|95.0|-96.3|-94.5|||Mixed Models Analysis|||Baseline to Day 60||-94.5|-96.3|<0.001
71147377|NCT05565742|141788406|SUPERIORITY||LS Mean difference (Final Values)|-95.5|STANDARD_ERROR_OF_MEAN|0.45|<|0.001|TWO_SIDED|95.0|-96.3|-94.5|||Mixed Models Analysis|||Baseline to Day 60||-94.5|-96.3|<0.001
71147378|NCT05565742|141788406|SUPERIORITY||LS Mean difference (Final Values)|-31.9|STANDARD_ERROR_OF_MEAN|11.1||0.019|TWO_SIDED|95.0|-50.6|-6.2|||Mixed Models Analysis|||Baseline to Day 180||-6.2|-50.6|0.019
71147379|NCT05565742|141788406|SUPERIORITY||LS Mean difference (Final Values)|-66.0|STANDARD_ERROR_OF_MEAN|4.52|<|0.001|TWO_SIDED|95.0|-73.8|-55.9|||Mixed Models Analysis|||Baseline to Day 180||-55.9|-73.8|<0.001
71147380|NCT05565742|141788406|SUPERIORITY||LS Mean difference (Final Values)|-90.7|STANDARD_ERROR_OF_MEAN|1.09|<|0.001|TWO_SIDED|95.0|-92.6|-88.3|||Mixed Models Analysis|||Baseline to Day 180||-88.3|-92.6|<0.001
71147381|NCT05565742|141788406|SUPERIORITY||LS Mean difference (Final Values)|-90.7|STANDARD_ERROR_OF_MEAN|1.09|<|0.001|TWO_SIDED|95.0|-92.6|-88.3|||Mixed Models Analysis|||Baseline to Day 180||-88.3|-92.6|<0.001
70874899|NCT02692716|141234259|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.77|||=|0.0952|TWO_SIDED|95.0|0.56|1.05||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed all-cause death, non-fatal myocardial infarction or non-fatal stroke was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.05|0.56|= 0.0952
70874900|NCT02692716|141234260|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.04||||0.8583|TWO_SIDED|95.0|0.66|1.66||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the on-treatment observation period. Time from first dose of trial product to first EAC-confirmed fatal or non-fatal myocardial infarction was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their on-treatment observation period.||1.66|0.66|0.8583
70874901|NCT02692716|141234261|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.76||||0.4485|TWO_SIDED|95.0|0.37|1.56||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed fatal or non-fatal stroke was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.56|0.37|0.4485
70874902|NCT02692716|141234262|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.51||||0.0078|TWO_SIDED|95.0|0.31|0.84||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed all-cause death was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||0.84|0.31|0.0078
70874903|NCT02692716|141234263|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.81|||<|0.0001|TWO_SIDED|95.0|1.42|2.3||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from date of first dose of trial product to date of end of treatment visit. Time from first dose to first AE leading to permanent trial product discontinuation was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the date of their end of treatment visit or at their end of study date, whichever came first.||2.30|1.42|<0.0001
71147382|NCT05565742|141788406|SUPERIORITY||LS Mean difference (Final Values)|-47.3|STANDARD_ERROR_OF_MEAN|8.25|<|0.001|TWO_SIDED|95.0|-61.3|-28.3|||Mixed Models Analysis|||Baseline to Day 240||-28.3|-61.3|<0.001
71147383|NCT05565742|141788406|SUPERIORITY||LS Mean difference (Final Values)|-84.7|STANDARD_ERROR_OF_MEAN|1.95|<|0.001|TWO_SIDED|95.0|-88.1|-80.3|||Mixed Models Analysis|||Baseline to Day 240||-80.3|-88.1|<0.001
71147384|NCT05565742|141788406|SUPERIORITY||LS Mean difference (Final Values)|-96.8|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|-97.4|-95.9|||Mixed Models Analysis|||Baseline to Day 240||-95.9|-97.4|<0.001
71147385|NCT05565742|141788406|SUPERIORITY||LS Mean difference (Final Values)|-84.7|STANDARD_ERROR_OF_MEAN|1.78|<|0.001|TWO_SIDED|95.0|-87.9|-80.8|||Mixed Models Analysis|||Baseline to Day 240||-80.8|-87.9|<0.001
71147386|NCT05565742|141788406|SUPERIORITY||LS Mean difference (Final Values)|-30.2|STANDARD_ERROR_OF_MEAN|11.45||0.029|TWO_SIDED|95.0|-49.4|-3.6|||Mixed Models Analysis|||Baseline to Day 360||-3.6|-49.4|0.029
71147387|NCT05565742|141788406|SUPERIORITY||LS Mean difference (Final Values)|-67.4|STANDARD_ERROR_OF_MEAN|4.35|<|0.001|TWO_SIDED|95.0|-74.9|-57.6|||Mixed Models Analysis|||Baseline to Day 360||-57.6|-74.9|<0.001
71147388|NCT05565742|141788406|SUPERIORITY||LS Mean difference (Final Values)|-91.0|STANDARD_ERROR_OF_MEAN|1.11|<|0.001|TWO_SIDED|95.0|-92.9|-88.5|||Mixed Models Analysis|||Baseline to Day 360||-88.5|-92.9|<0.001
71147389|NCT05565742|141788406|SUPERIORITY||LS Mean difference (Final Values)|-67.8|STANDARD_ERROR_OF_MEAN|3.96|<|0.001|TWO_SIDED|95.0|-74.8|-59.0|||Mixed Models Analysis|||Baseline to Day 360||-59.0|-74.8|<0.001
71147390|NCT05565742|141788406|SUPERIORITY||LS Mean difference (Final Values)|-19.7|STANDARD_ERROR_OF_MEAN|10.45||0.093|TWO_SIDED|95.0|-37.8|3.7|||Mixed Models Analysis|||Baseline to Day 540||3.7|-37.8|0.093
71147391|NCT05565742|141788406|SUPERIORITY||LS Mean difference (Final Values)|-45.8|STANDARD_ERROR_OF_MEAN|5.76|<|0.001|TWO_SIDED|95.0|-56.0|-33.2|||Mixed Models Analysis|||Baseline to Day 540||-33.2|-56.0|<0.001
71147392|NCT05565742|141788406|SUPERIORITY||LS Mean difference (Final Values)|-74.2|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|-78.8|-68.5|||Mixed Models Analysis|||Baseline to Day 540||-68.5|-78.8|<0.001
71147393|NCT05565742|141788406|SUPERIORITY||LS Mean difference (Final Values)|-53.4|STANDARD_ERROR_OF_MEAN|4.67|<|0.001|TWO_SIDED|95.0|-61.7|-43.3|||Mixed Models Analysis|||Baseline to Day 540||-43.3|-61.7|<0.001
71147394|NCT05565742|141788407|SUPERIORITY||LS Mean difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|3.74||0.01|TWO_SIDED|95.0|-17.5|-2.6|||Mixed Models Analysis|||Baseline to Day 60||-2.6|-17.5|0.010
71147395|NCT05565742|141788407|SUPERIORITY||LS Mean difference (Final Values)|-11.9|STANDARD_ERROR_OF_MEAN|3.02|<|0.001|TWO_SIDED|95.0|-17.7|-5.8|||Mixed Models Analysis|||Baseline to Day 60||-5.8|-17.7|<0.001
71147396|NCT05565742|141788407|SUPERIORITY||LS Mean difference (Final Values)|-14.1|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|-19.0|-8.8|||Mixed Models Analysis|||Baseline to Day 60||-8.8|-19.0|<0.001
71147397|NCT05565742|141788407|SUPERIORITY||LS Mean difference (Final Values)|-14.1|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|-19.0|-8.8|||Mixed Models Analysis|||Baseline to Day 60||-8.8|-19.0|<0.001
71147398|NCT05565742|141788407|SUPERIORITY||LS Mean difference (Final Values)|-8.2|STANDARD_ERROR_OF_MEAN|4.27||0.068|TWO_SIDED|95.0|-16.2|0.6|||Mixed Models Analysis|||Baseline to Day 180||0.6|-16.2|0.068
71147399|NCT05565742|141788407|SUPERIORITY||LS Mean difference (Final Values)|-10.7|STANDARD_ERROR_OF_MEAN|3.4||0.003|TWO_SIDED|95.0|-17.1|-3.8|||Mixed Models Analysis|||Baseline to Day 180||-3.8|-17.1|0.003
70874904|NCT02782780|141234276|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses|||||<|0.01||||||Test of treatment effect: t(91.6)=3.21|Mixed Models Analysis|||||||<0.01
71147400|NCT05565742|141788407|SUPERIORITY||LS Mean difference (Final Values)|-13.7|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-19.3|-7.9|||Mixed Models Analysis|||Baseline to Day 180||-7.9|-19.3|<0.001
71147401|NCT05565742|141788407|SUPERIORITY||LS Mean difference (Final Values)|-13.7|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-19.3|-7.9|||Mixed Models Analysis|||Baseline to Day 180||-7.9|-19.3|<0.001
71147402|NCT05565742|141788407|SUPERIORITY||LS Mean difference (Final Values)|-9.2|STANDARD_ERROR_OF_MEAN|3.93||0.026|TWO_SIDED|95.0|-16.7|-1.2|||Mixed Models Analysis|||Baseline to Day 240||-1.2|-16.7|0.026
71147403|NCT05565742|141788407|SUPERIORITY||LS Mean difference (Final Values)|-15.4|STANDARD_ERROR_OF_MEAN|2.99|<|0.001|TWO_SIDED|95.0|-21.1|-9.3|||Mixed Models Analysis|||Baseline to Day 240||-9.3|-21.1|<0.001
71147404|NCT05565742|141788407|SUPERIORITY||LS Mean difference (Final Values)|-15.5|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|-21.0|-9.6|||Mixed Models Analysis|||Baseline to Day 240||-9.6|-21.0|<0.001
71147405|NCT05565742|141788407|SUPERIORITY||LS Mean difference (Final Values)|-10.6|STANDARD_ERROR_OF_MEAN|3.03|<|0.001|TWO_SIDED|95.0|-16.3|-4.4|||Mixed Models Analysis|||Baseline to Day 240||-4.4|-16.3|<0.001
71147406|NCT05565742|141788407|SUPERIORITY||LS Mean difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|4.21||0.111|TWO_SIDED|95.0|-14.9|1.7|||Mixed Models Analysis|||Baseline to Day 360||1.7|-14.9|0.111
70955709|NCT04797650|141415056|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.9|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-1.3|-1.9|< 0.0001
71147407|NCT05565742|141788407|SUPERIORITY||LS Mean difference (Final Values)|-12.0|STANDARD_ERROR_OF_MEAN|3.25|<|0.001|TWO_SIDED|95.0|-18.1|-5.3|||Mixed Models Analysis|||Baseline to Day 360||-5.3|-18.1|<0.001
71147408|NCT05565742|141788407|SUPERIORITY||LS Mean difference (Final Values)|-14.1|STANDARD_ERROR_OF_MEAN|3.11|<|0.001|TWO_SIDED|95.0|-20.0|-7.8|||Mixed Models Analysis|||Baseline to Day 360||-7.8|-20.0|<0.001
71147409|NCT05565742|141788407|SUPERIORITY||LS Mean difference (Final Values)|-8.6|STANDARD_ERROR_OF_MEAN|3.3||0.013|TWO_SIDED|95.0|-14.9|-1.9|||Mixed Models Analysis|||400 mg LY3819469, Placebo||-1.9|-14.9|0.013
71147410|NCT05565742|141788407|SUPERIORITY||LS Mean difference (Final Values)|-2.8|STANDARD_ERROR_OF_MEAN|4.2||0.51|TWO_SIDED|95.0|-10.7|5.8|||Mixed Models Analysis|||Baseline to Day 540||5.8|-10.7|0.510
71147411|NCT05565742|141788407|SUPERIORITY||LS Mean difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|3.35||0.173|TWO_SIDED|95.0|-11.1|2.1|||Mixed Models Analysis|||Baseline to Day 540||2.1|-11.1|0.173
71147412|NCT05565742|141788407|SUPERIORITY||LS Mean difference (Final Values)|-12.9|STANDARD_ERROR_OF_MEAN|3.01|<|0.001|TWO_SIDED|95.0|-18.6|-6.8|||Mixed Models Analysis|||Baseline to Day 540||-6.8|-18.6|<0.001
71147413|NCT05565742|141788407|SUPERIORITY||LS Mean difference (Final Values)|-5.0|STANDARD_ERROR_OF_MEAN|3.27||0.139|TWO_SIDED|95.0|-11.2|1.7|||Mixed Models Analysis|||Baseline to Day 540||1.7|-11.2|0.139
71147414|NCT05565742|141788408|SUPERIORITY||LS Mean difference (Final Values)|-17.1|STANDARD_ERROR_OF_MEAN|16.71||0.353|TWO_SIDED|95.0|-44.3|23.3|||Mixed Models Analysis|||Baseline to Day 60||23.3|-44.3|0.353
71147415|NCT05565742|141788408|SUPERIORITY||LS Mean difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|15.84||0.902|TWO_SIDED|95.0|-28.7|34.7|||Mixed Models Analysis|||Baseline to Day 60||34.7|-28.7|0.902
71147416|NCT05565742|141788408|SUPERIORITY||LS Mean difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|13.65||0.779|TWO_SIDED|95.0|-27.4|27.1|||Mixed Models Analysis|||Baseline to Day 60||27.1|-27.4|0.779
71147417|NCT05565742|141788408|SUPERIORITY||LS Mean difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|13.65||0.779|TWO_SIDED|95.0|-27.4|27.1|||Mixed Models Analysis|||Baseline to Day 60||27.1|-27.4|0.779
71147418|NCT05565742|141788408|SUPERIORITY||LS Mean difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|20.41||0.987|TWO_SIDED|95.0|-32.8|49.7|||Mixed Models Analysis|||Baseline to Day 180||49.7|-32.8|0.987
71147419|NCT05565742|141788408|SUPERIORITY||LS Mean difference (Final Values)|-15.2|STANDARD_ERROR_OF_MEAN|13.96||0.316|TWO_SIDED|95.0|-38.7|17.2|||Mixed Models Analysis|||Baseline to Day 180||17.2|-38.7|0.316
71147420|NCT05565742|141788408|SUPERIORITY||LS Mean difference (Final Values)|5.4|STANDARD_ERROR_OF_MEAN|15.37||0.72|TWO_SIDED|95.0|-20.9|40.4|||Mixed Models Analysis|||Baseline to Day 180||40.4|-20.9|0.720
71147421|NCT05565742|141788408|SUPERIORITY||LS Mean difference (Final Values)|5.4|STANDARD_ERROR_OF_MEAN|15.37||0.72|TWO_SIDED|95.0|-20.9|40.4|||Mixed Models Analysis|||Baseline to Day 180||40.4|-20.9|0.720
71147422|NCT05565742|141788408|SUPERIORITY||LS Mean difference (Final Values)|-11.5|STANDARD_ERROR_OF_MEAN|14.66||0.461|TWO_SIDED|95.0|-36.1|22.6|||Mixed Models Analysis|||Baseline to Day 240||22.6|-36.1|0.461
71147423|NCT05565742|141788408|SUPERIORITY||LS Mean difference (Final Values)|-16.1|STANDARD_ERROR_OF_MEAN|11.29||0.194|TWO_SIDED|95.0|-35.6|9.4|||Mixed Models Analysis|||Baseline to Day 240||9.4|-35.6|0.194
71147424|NCT05565742|141788408|SUPERIORITY||LS Mean difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|12.87||0.898|TWO_SIDED|95.0|-24.0|27.2|||Mixed Models Analysis|||Baseline to Day 240||27.2|-24.0|0.898
70874905|NCT02782780|141234276|SUPERIORITY||||||<|0.001||||||Baseline vs. 6-month follow-up in CBTI group: t(92.3)=4.10|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTI group.||||||<0.001
70874906|NCT02782780|141234277|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses|||||<|0.001||||||test of treatment effect: t(94.7)=6.10|Mixed Models Analysis|||||||<0.001
70874907|NCT02782780|141234277|SUPERIORITY||||||<|0.001||||||baseline vs. 6-month follow-up in CBTI group: t(94)=6.67|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTI group.||To compare baseline data to 6-month follow-up data in the CBT-I group, planned contrasts following the mixed models were used.||||<0.001
70955710|NCT04797650|141415056|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-2.2|-1.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-1.5|-2.2|< 0.0001
70874908|NCT02782780|141234278|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses|||||<|0.001|||||||Mixed Models Analysis|test of treatment effect: t(104)=3.40||||||<0.001
70874909|NCT02782780|141234278|SUPERIORITY||||||<|0.001||||||Baseline vs. 6-month follow-up in CBTi group: t(91.6)=4.37|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.||||||<0.001
70955711|NCT04797650|141415056|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-2.0|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.3|-2|< 0.0001
71147425|NCT05565742|141788408|SUPERIORITY||LS Mean difference (Final Values)|-9.4|STANDARD_ERROR_OF_MEAN|11.81||0.448|TWO_SIDED|95.0|-29.9|17.0|||Mixed Models Analysis|||Baseline to Day 240||17.0|-29.9|0.448
71147426|NCT05565742|141788408|SUPERIORITY||LS Mean difference (Final Values)|29.6|STANDARD_ERROR_OF_MEAN|28.05||0.233|TWO_SIDED|95.0|-15.4|98.4|||Mixed Models Analysis|||Baseline to Day 360||98.4|-15.4|0.233
71147427|NCT05565742|141788408|SUPERIORITY||LS Mean difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|18.04||0.891|TWO_SIDED|95.0|-27.6|44.9|||Mixed Models Analysis|||Baseline to Day 360||44.9|-27.6|0.891
71147428|NCT05565742|141788408|SUPERIORITY||LS Mean difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|17.18||0.984|TWO_SIDED|95.0|-29.0|39.9|||Mixed Models Analysis|||Baseline to Day 360||39.9|-29.0|0.984
71147429|NCT05565742|141788408|SUPERIORITY||LS Mean difference (Final Values)|19.4|STANDARD_ERROR_OF_MEAN|20.52||0.302|TWO_SIDED|95.0|-14.8|67.5|||Mixed Models Analysis|||Baseline to Day 360||67.5|-14.8|0.302
71147430|NCT05565742|141788408|SUPERIORITY||LS Mean difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|18.49||0.684|TWO_SIDED|95.0|-37.9|36.8|||Mixed Models Analysis|||Baseline to Day 540||36.8|-37.9|0.684
71147431|NCT05565742|141788408|SUPERIORITY||LS Mean difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|16.19||0.933|TWO_SIDED|95.0|-28.6|36.3|||Mixed Models Analysis|||Baseline to Day 540||36.3|-28.6|0.933
71147432|NCT05565742|141788408|SUPERIORITY||LS Mean difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|16.33||0.962|TWO_SIDED|95.0|-26.7|38.6|||Mixed Models Analysis|||Baseline to Day 540||38.6|-26.7|0.962
71147433|NCT05565742|141788408|SUPERIORITY||LS Mean difference (Final Values)|13.9|STANDARD_ERROR_OF_MEAN|18.52||0.422|TWO_SIDED|95.0|-17.2|56.9|||Mixed Models Analysis|||Baseline to Day 540||56.9|-17.2|0.422
71147434|NCT02855125|141788410|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.2744|TWO_SIDED|95.0|0.71|1.88|||Log Rank|1-sided stratified log-rank test.|Based on stratified Cox regression model .|||1.88|0.71|0.2744
71147435|NCT02855125|141788411|SUPERIORITY||Hazard Ratio (HR)|1.31||||0.1431|TWO_SIDED|95.0|0.8|2.14|||Log Rank|1-sided stratified log-rank test.|Based on stratified Cox regression model.|||2.14|0.80|0.1431
71147436|NCT04467905|141788416|SUPERIORITY||Mean Difference (Final Values)|-29.9|||<|0.0001|TWO_SIDED|95.0|-40.3|-19.3|||ANCOVA||The mean difference is the difference in adjusted means for the change between baseline value and nadir in the placebo group and the change between baseline and nadir in the etripamil group.|||-19.3|-40.3|<0.0001
71147437|NCT00744497|141788429|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.9009|TWO_SIDED|95.53|0.87|1.13||An interim analysis on survival was performed and the final test was corrected for multiplicity.|Log Rank|||Confidence intervals for median overall survival calculated using Brookmeyer and Crowley method. Compared survival in arms by 2-sided, alpha=0.0447 level, log-rank test, stratified by bisphosphonate intake (yes/no) and urinary N-telopeptide category (\<60 vs ≥60 nmol/mmol creatinine) defined at randomization. Null hypothesis was survival equal in both arms. Power calculations were that ≥858 deaths would lead to ≥90% power at 5% level for rejecting null hypothesis, given true hazard ratio of 0.8.||1.13|0.87|0.9009
71147438|NCT00744497|141788430|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.935|||||TWO_SIDED|95.0|0.688|1.271||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The odds ratio is presented for experimental to control group.||1.271|0.688|
71147439|NCT00744497|141788431|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.64|1.02||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The hazard ratio is presented for experimental to control group.||1.02|0.64|
71147440|NCT00744497|141788432|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.93|1.763||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The odds ratio is presented for experimental to control group.||1.763|0.930|
71147441|NCT00744497|141788433|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.82|1.05||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The hazard ratio is presented for experimental to control group.||1.05|0.82|
71147442|NCT00744497|141788434|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.79|1.01||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The hazard ratio is presented for experimental to control group.||1.01|0.79|
71147443|NCT00744497|141788435|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.791|||||TWO_SIDED|95.0|0.594|1.052||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The odds ratio is presented for of experimental to control group.||1.052|0.594|
71147444|NCT03819114|141788453|EQUIVALENCE|Confidence Interval (CI) on Geometric Mean Ratio compared to reference interval (0.7, 1.43).|Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.81|1.2|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.20|0.81|
71147445|NCT03819114|141788453|EQUIVALENCE|Confidence Interval on Geometric Mean Ratio compared to reference interval (0.7, 1.43).|Geometric Mean Ratio|1.34|||||TWO_SIDED|90.0|1.12|1.6|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.60|1.12|
71147446|NCT03819114|141788453|SUPERIORITY|Confidence Interval on Geometric Mean Ratio excluding 1.|Geometric Mean Ratio|1.66|||||TWO_SIDED|90.0|1.27|2.18|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||2.18|1.27|
71147447|NCT03819114|141788453|SUPERIORITY|Confidence Interval on Geometric Mean Ratio excluding 1.|Geometric Mean Ratio|0.59|||||TWO_SIDED|90.0|0.45|0.78|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.78|0.45|
71147448|NCT03819114|141788454|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons were made. Statistical significance was declared if p\<0.05.|Fisher Exact|||||||1.00
71147449|NCT03819114|141788455|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.17|||||TWO_SIDED|90.0|0.96|1.41|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.41|0.96|
71147450|NCT03819114|141788455|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.43|||||TWO_SIDED|90.0|1.21|1.69|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.69|1.21|
71147451|NCT03819114|141788455|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.51|||||TWO_SIDED|90.0|1.17|1.96|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.96|1.17|
71147452|NCT03819114|141788455|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.77|||||TWO_SIDED|90.0|0.6|1.0|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.00|0.60|
71147453|NCT03819114|141788456|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.37|||||TWO_SIDED|90.0|0.22|0.61|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.61|0.22|
71147454|NCT03819114|141788456|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.25|||||TWO_SIDED|90.0|0.15|0.44|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.44|0.15|
71147455|NCT03819114|141788456|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|2.11|||||TWO_SIDED|90.0|1.2|3.7|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||3.70|1.20|
71147456|NCT03819114|141788456|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.17|||||TWO_SIDED|90.0|0.09|0.32|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.32|0.09|
70874910|NCT02782780|141234279|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses|||||<|0.05|||||||Mixed Models Analysis|test of treatment effect: t(99.9)=2.09||||||<0.05
70874911|NCT02782780|141234279|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|Baseline vs. 6-month follow-up in CBTi group: t(92.1)=2.56||Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.||||<0.01
71147457|NCT03819114|141788457|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|4.03|||||TWO_SIDED|90.0|3.17|5.12|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||5.12|3.17|
71147458|NCT03819114|141788457|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|2.92|||||TWO_SIDED|90.0|2.33|3.65|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||3.65|2.33|
70874912|NCT02782780|141234280|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses|||||=|0.991|||||||Mixed Models Analysis|Test of treatment effect: t(110)=-0.41||||||=0.991
70874913|NCT02782780|141234280|SUPERIORITY||||||=|0.41||||||Baseline vs. 6-month follow-up in CBTi group: t(91.8)=0.94|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.||||||=0.41
70874914|NCT02782780|141234281|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses|||||<|0.05|||||||Mixed Models Analysis|Test of treatment effect: t(83.7)=2.51||||||<0.05
70874915|NCT02782780|141234281|SUPERIORITY||||||=|0.49||||||Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.|Mixed Models Analysis|Baseline vs. 6-month follow-up in CBTi group: t(90.9)=0.27||||||=0.49
70874916|NCT02782780|141234282|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses.|||||<|0.01|||||||Mixed Models Analysis|test of treatment effect: t(105)=4.55||||||<0.01
70874917|NCT02782780|141234282|SUPERIORITY||||||<|0.01||||||Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.|Mixed Models Analysis|Baseline vs. 6-month follow-up in CBTi group: t(91.3)=3.23||||||<0.01
70874918|NCT02782780|141234283|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses.|||||<|0.001|||||||Mixed Models Analysis|Test of treatment effect: t(91.6)=3.37||||||<0.001
71147459|NCT03819114|141788457|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.11|||||TWO_SIDED|90.0|0.82|1.52|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.52|0.82|
71147460|NCT03819114|141788457|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|3.62|||||TWO_SIDED|90.0|2.65|4.93|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||4.93|2.65|
71147461|NCT03819114|141788458|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|2.1|||||TWO_SIDED|90.0|1.66|2.65|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||2.65|1.66|
71147462|NCT03819114|141788458|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.11|||||TWO_SIDED|90.0|0.89|1.39|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.39|0.89|
71147463|NCT03819114|141788458|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.2|||||TWO_SIDED|90.0|0.87|1.66|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.66|0.87|
71147464|NCT03819114|141788458|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.75|||||TWO_SIDED|90.0|1.24|2.45|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||2.45|1.24|
71147465|NCT03819114|141788459|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.52|||||TWO_SIDED|90.0|0.46|0.59|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.59|0.46|
71147466|NCT03819114|141788459|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.38|||||TWO_SIDED|90.0|0.34|0.43|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.43|0.34|
71147467|NCT03819114|141788459|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.08|||||TWO_SIDED|90.0|0.93|1.25|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.25|0.93|
70874919|NCT02782780|141234283|SUPERIORITY||||||<|0.001||||||Baseline vs. 6-month follow-up in CBTi group: (92.1)=3.64|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.||||||<0.001
71147468|NCT03819114|141788459|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.48|||||TWO_SIDED|90.0|0.41|0.56|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.56|0.41|
71147469|NCT03819114|141788461|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.75|||||TWO_SIDED|90.0|0.6|0.93|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.93|0.60|
71147470|NCT03819114|141788461|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.1|||||TWO_SIDED|90.0|0.9|1.36|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.36|0.90|
71147471|NCT03819114|141788461|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.74|||||TWO_SIDED|90.0|1.29|2.33|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||2.33|1.29|
71147472|NCT03819114|141788461|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.43|||||TWO_SIDED|90.0|0.32|0.58|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.58|0.32|
71147473|NCT03819114|141788462|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.62|||||TWO_SIDED|90.0|0.49|0.78|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.78|0.49|
71147474|NCT03819114|141788462|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.89|||||TWO_SIDED|90.0|0.71|1.1|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.10|0.71|
71147475|NCT03819114|141788462|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.77|||||TWO_SIDED|90.0|1.31|2.4|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||2.40|1.31|
71147476|NCT03819114|141788462|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.35|||||TWO_SIDED|90.0|0.26|0.47|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.47|0.26|
71147477|NCT03819114|141788463|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.5|||||TWO_SIDED|90.0|0.39|0.63|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.63|0.39|
71147478|NCT03819114|141788463|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.69|||||TWO_SIDED|90.0|0.55|0.86|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.86|0.55|
71147479|NCT03819114|141788463|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.8|||||TWO_SIDED|90.0|1.32|2.45|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||2.45|1.32|
71147480|NCT03819114|141788463|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.28|||||TWO_SIDED|90.0|0.2|0.38|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.38|0.20|
71147481|NCT02584686|141788545|SUPERIORITY_OR_OTHER|||||||0.0049|||||||t-test, 1 sided|||Comparing the mean PSV before \& after treatment in the study group using the t-test.||||0.0049
71147482|NCT02584686|141788545|SUPERIORITY_OR_OTHER|||||||0.68|||||||t-test, 1 sided|||Comparing the mean PSV before \& after treatment in the control group using the t-test.||||0.68
71147483|NCT02584686|141788547|SUPERIORITY_OR_OTHER|||||||0.01086956|||||||Wilcoxon (Mann-Whitney)|||Comparing the Erection hardness score before \& after treatment in the study group.||||0.01086956
71147484|NCT02584686|141788547|SUPERIORITY_OR_OTHER|||||||0.6618176|||||||Wilcoxon (Mann-Whitney)|||Comparing the Erection hardness score before \& after treatment in the control group.||||0.6618176
71147485|NCT02584686|141788549|SUPERIORITY_OR_OTHER|||||||0.00751288|||||||Wilcoxon (Mann-Whitney)|||SHIM Score in the study group before \& after treatment.||||0.00751288
70955712|NCT04797650|141415056|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-2.5|-1.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.7|-2.5|< 0.0001
70955713|NCT04797650|141415056|SUPERIORITY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-2.5|-1.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.8|-2.5|< 0.0001
71147486|NCT02584686|141788549|SUPERIORITY_OR_OTHER|||||||0.6618176|||||||Wilcoxon (Mann-Whitney)|||SHIM Score in the control group before \& after treatment.||||0.6618176
71147487|NCT02584686|141788550|SUPERIORITY_OR_OTHER|||||||0.027191||||||"Due to the small sample size Fisher exact test was chosen. 7 out of 12 in the treatment group answered yes, while 1 out of 12 in the control group answered yes."|Fisher Exact|||||||0.027191
71147488|NCT02584686|141788552|SUPERIORITY_OR_OTHER|||||||0.109091|||||||Fisher Exact|||"Fisher Exact Test was used to compare the change in the number of in patients who answered Yes in Secondary Outcome 8 (SEP-Q2 Question Before Treatment) to patients who answered Yes in Secondary Outcome 9 (SEP-Q2 Question after Treatment), for both (BTXA) and Saline groups."||||0.109091
71147489|NCT02584686|141788554|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||"Fisher Exact Test was used to compare the change in patients who answered Yes in Secondary Outcome 10 (SEP-Q3 Question Before Treatment) to patients who answered Yes in Secondary Outcome 11 (SEP-Q3 Question after Treatment)."||||1
71147490|NCT01709721|141788555|SUPERIORITY|||||||0.147|||||||Chi-squared|Pearson's chi-square test||Superiority of intrathecal hydromorphone hydrochloride as compared to a control arm.||||0.147
71147491|NCT01709721|141788556|SUPERIORITY|||||||0.0342|||||||ANCOVA|||"P-value by ANCOVA, with randomization group as the factor and initial parameter value as covariate.~Note: For subjects with missing endpoint on Day 119, value is imputed using the Last Observation Carried Forward (LOCF).~Note: Baseline for this analysis is the Day 84 visit."||||0.0342
70955714|NCT04797650|141415056|SUPERIORITY||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-2.8|-2.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-2|-2.8|< 0.0001
70955715|NCT04797650|141415057|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.8|-1.0||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-1|-1.8|< 0.0001
70955716|NCT04797650|141415057|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-2.0|-1.1||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-1.1|-2|< 0.0001
70955717|NCT04797650|141415057|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-2.0|-1.2||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-1.2|-2|< 0.0001
71147492|NCT01709721|141788557|SUPERIORITY|||||||0.1642|||||||ANCOVA|||"P-value by ANCOVA, with randomization group as the factor and initial parameter value as covariate.~Note: For subjects with missing endpoint on Day 119, value is imputed using the Last Observation Carried Forward (LOCF).~Note: Baseline for this analysis is the Day 84 visit."||||0.1642
71147493|NCT01709721|141788558|SUPERIORITY|||||||0.016|||||||ANCOVA|ANCOVA, with randomization group as the factor and initial parameter value as covariate.||"P-value by ANCOVA, with randomization group as the factor and initial parameter value as covariate.~Note: For subjects with missing endpoint on Day 119, value is imputed using the Last Observation Carried Forward (LOCF).~Note: Baseline for this analysis is the Day 84 visit."||||0.0160
71147494|NCT01709721|141788559|SUPERIORITY|||||||0.0007|||||||ANCOVA|ANCOVA, with randomization group as the factor and initial parameter value as covariate.||"P-value by ANCOVA, with randomization group as the factor and initial parameter value as covariate.~Note: For subjects with missing endpoint on Day 119, value is imputed using the Last Observation Carried Forward (LOCF).~Note: Baseline for this analysis is the Day 84 visit."||||0.0007
70955718|NCT04797650|141415057|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-2.3|-1.4||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-1.4|-2.3|< 0.0001
71147495|NCT01709721|141788560|SUPERIORITY|||||||0.0088||||||ANCOVA, with randomization group as the factor and initial parameter value as covariate.|ANCOVA|||"P-value by ANCOVA, with randomization group as the factor and initial parameter value as covariate.~Note: For subjects with missing endpoint on Day 119, value is imputed using the Last Observation Carried Forward (LOCF).~Note: Baseline for this analysis is the Day 84 visit."||||0.0088
71147496|NCT01709721|141788561|SUPERIORITY|||||||0.011||||||Log-rank test for Kaplan-Meier Estimate of Time to Rescue (days).|Log Rank|||||||0.011
71147497|NCT01709721|141788562|SUPERIORITY|||||||0.0335|||||||Cochran-Mantel-Haenszel|||P-value by the Cochran-Mantel-Haenszel mean score test (using equally spaced scores).||||0.0335
70955719|NCT04797650|141415057|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-2.2|-1.3||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.3|-2.2|< 0.0001
70955720|NCT04797650|141415057|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-2.4|-1.5||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.5|-2.4|< 0.0001
70955721|NCT04797650|141415057|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-2.5|-1.7||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.7|-2.5|< 0.0001
70955722|NCT04797650|141415057|SUPERIORITY||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-2.8|-1.8||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.8|-2.8|< 0.0001
70955723|NCT04797650|141415058|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.05|0.12||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 12||0.12|0.05|< 0.0001
71147498|NCT01709721|141788564|SUPERIORITY|Pearson's chi-square test||||||0.01||||||Pearson's chi-square test|Chi-squared|||||||0.010
70955724|NCT04797650|141415058|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001|TWO_SIDED|95.0|0.06|0.17||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 12||0.17|0.06|< 0.0001
70955725|NCT04797650|141415058|SUPERIORITY||Risk Difference (RD)|0.33|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.27|0.38||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 24||0.38|0.27|< 0.0001
71147499|NCT03137381|141788576|SUPERIORITY|||||||0.177|||||||Chi-squared|||||||0.177
71147500|NCT03137381|141788576|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71147501|NCT03137381|141788576|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
70874920|NCT02782780|141234284|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses.|||||<|0.001|||||||Mixed Models Analysis|Test of treatment effect: t(99.2)=5.45||||||<0.001
70874921|NCT02782780|141234284|SUPERIORITY||||||<|0.001||||||Baseline vs. 6-month follow-up in CBTi group: t(93.4)=6.06|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.||||||<0.001
70874922|NCT02782780|141234285|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses.|||||<|0.001|||||||Mixed Models Analysis|test of treatment effect: t(76.9)=-4.20||||||<0.001
70874923|NCT02782780|141234285|SUPERIORITY||||||<|0.001||||||Baseline vs. 6-month follow-up in CBTi group: t(33.1)=6.52|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.||||||<0.001
70874924|NCT02782780|141234286|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses.|||||<|0.001|||||||Mixed Models Analysis|Test of treatment effect: t(75.6)=4.33||||||<0.001
70874925|NCT02782780|141234286|SUPERIORITY||||||<|0.001||||||Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.|Mixed Models Analysis|Baseline vs. 6-month follow-up in CBTi group: t(34.4)=4.75||||||<0.001
70874926|NCT02782780|141234287|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses.|||||<|0.001|||||||Mixed Models Analysis|Test of treatment effect: t(75.1)=3.91||||||<0.001
70874927|NCT02782780|141234287|SUPERIORITY||||||<|0.001||||||Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.|Mixed Models Analysis|Baseline vs. 6-month in CBTi group: t(34.5)=4.39||||||<0.001
70874928|NCT03562481|141234288|EQUIVALENCE|Analysis of variance for a 2x2 crossover study implemented using the pkcross routine of Stata 16.1, accounting of sequence and period effects.|F statistic|0.8||||0.38|TWO_SIDED|||||The threshold for statistical significance p\<0.05|ANOVA|Analysis of variance for a 2x2 crossover study implemented using the pkcross routine of Stata 16.1, accounting of sequence and period effects.||||||0.38
70874929|NCT03562481|141234289|EQUIVALENCE|Equivalence was defined as a non-statistically significant difference.|F statistic|1.21||||0.28|TWO_SIDED|||||The threshold for statistical significance p\<0.05|ANOVA|||Analysis of variance for 2x2 crossover study using the pkcross routine of Stata 16.1 and accounting for sequence and period effects.||||0.28
70874930|NCT03562481|141234290|EQUIVALENCE|Equivalence was defined based on statistical significance in the cross-over ANOVA.|F statistic|11.1||||0.003|TWO_SIDED|||||This is adjusted for period and sequence effects and is statistically significant at the p\<0.05 level.|ANOVA|||Analysis of variance for 2x2 crossover study using the pkcross routine of Stata 16.1 adjusting for perio and sequence effects.||||0.003
70874931|NCT03562481|141234291|EQUIVALENCE|Equivalence was determined based on the statistical significance of the Wilcoxon signed-rank test.|Z score|-0.996||||0.33|TWO_SIDED|||||The threshold for statistical significance p\<0.05|Sign test|Wilcoxon signed-rank test||||||0.33
70874932|NCT03562481|141234292|EQUIVALENCE|Equivalence was determined based on the statistical significance of the chi square test.|Chi-square test|0.81||||0.37|TWO_SIDED|||||The threshold for statistical significance p\<0.05|Chi-squared|||||||0.37
70874933|NCT03562481|141234293|EQUIVALENCE|Equivalence was defined based on statistical significance in the symmetry test.|Chi-square test|0.2||||0.65|TWO_SIDED|||||The threshold for statistical significance p\<0.05|Sruart-Maxwell symmetry test|||Stuart-Maxwell test of marginal homogeneity implemented with the symmetry routine in Stata 16.1||||0.65
70874934|NCT03562481|141234294|EQUIVALENCE|Equivalence was defined based on significance in the symmetry test.|Chi-square test|0.14||||0.71|TWO_SIDED|||||The threshold for statistical significance p\<0.05|Sruart-Maxwell symmetry test|||Test of symmetry or marginal homogeneity (Stuart-Maxwell) implemented with the symmetry routine in Stata 16.1.||||0.71
70874935|NCT03562481|141234295|EQUIVALENCE|Equivalence was defined based on statistical significance in the symmetry test.|Chi-square test|1.0||||0.32|TWO_SIDED|||||The threshold for statistical significance p\<0.05|Sruart-Maxwell symmetry test|||Test of symmetry (marginal homogeneity, Stuart-Maxwell) implemented using the symmetry routine in Stata 16.1.||||0.32
70874936|NCT03562481|141234296|EQUIVALENCE|Equivalence was defined based on the statistical significance of the symmetry test.|Chi-square test|1.29||||0.26|TWO_SIDED||||||Sruart-Maxwell symmetry test|||Test of symmetry (marginal homogeneity, Stuart-Maxwell) implemented using the symmetry routine in Stata 16.1.||||0.26
70874937|NCT02664441|141234297|SUPERIORITY||Mean Difference (Net)|-1.7||||0.4|TWO_SIDED|95.0|-4.1|0.6|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) were used as covariates.||||0.6|-4.1|0.40
70874938|NCT02664441|141234298|SUPERIORITY||Mean Difference (Net)|-3.1||||0.02|TWO_SIDED|95.0|-5.7|-0.4|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) were used as covariates.||||-0.4|-5.7|0.02
70874939|NCT02664441|141234299|SUPERIORITY||Mean Difference (Final Values)|-20.2||||0.032|TWO_SIDED|95.0|-37.8|-2.7|||Regression, Linear|Adjusted for baseline values||Analysis for Fat Intake||-2.7|-37.8|.032
70874940|NCT02664441|141234299|SUPERIORITY||Mean Difference (Net)|-430.0||||0.02|TWO_SIDED|95.0|-761.0|-100.0|||Regression, Linear|Adjusted for baseline values||Analysis for Total Calorie Intake||-100|-761|.02
70874941|NCT02664441|141234300|SUPERIORITY||Geometric Mean Ratio|1.42||||0.19|TWO_SIDED|95.0|0.97|2.08|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) as covariates.|Data were log-transformed prior to analysis. Results were back-transformed through exponentiation and presented as geometric mean ratios with 95% confidence intervals|||2.08|0.97|0.19
70874942|NCT02664441|141234301|SUPERIORITY||Geometric Mean Ratio|1.0||||0.82|TWO_SIDED|95.0|0.91|1.11|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) as covariates.|Data were log-transformed prior to analysis. Results were back-transformed through exponentiation and presented as geometric mean ratios with 95% confidence intervals|Analysis for HDL Cholesterol||1.11|0.91|0.82
70955726|NCT04797650|141415058|SUPERIORITY||Risk Difference (RD)|0.37|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|0.28|0.45||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 24||0.45|0.28|< 0.0001
70874943|NCT02664441|141234301|SUPERIORITY||Geometric Mean Ratio|1.0||||0.92|TWO_SIDED|95.0|0.83|1.19|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) as covariates.|Data were log-transformed prior to analysis. Results were back-transformed through exponentiation and presented as geometric mean ratios with 95% confidence intervals|Analysis for Triglycerides||1.19|0.83|0.92
70955727|NCT04797650|141415058|SUPERIORITY||Risk Difference (RD)|0.02|STANDARD_ERROR_OF_MEAN|0.009||0.0409|TWO_SIDED|95.0|0.0|0.03||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 12||0.03|0.00|0.0409
70874944|NCT02664441|141234302|SUPERIORITY||Geometric Mean Ratio|0.62||||0.03|TWO_SIDED|95.0|0.41|0.92|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) as covariates|Data were log-transformed prior to analysis. Results were back-transformed through exponentiation and presented as geometric mean ratios with 95% confidence intervals|||0.92|0.41|0.03
70874945|NCT02664441|141234303|SUPERIORITY||Geometric Mean Ratio|1.39||||0.32|TWO_SIDED|95.0|0.9|2.14|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) as covariates|Data were log-transformed prior to analysis. Results were back-transformed through exponentiation and presented as geometric mean ratios with 95% confidence intervals|||2.14|0.90|0.32
70874946|NCT02664441|141234304|SUPERIORITY||Geometric Mean Ratio|0.95||||0.69|TWO_SIDED|95.0|0.81|1.1|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) were used as covariates.|Data were log-transformed prior to analysis. Results were back-transformed through exponentiation and presented as geometric mean ratios with 95% confidence intervals.|||1.10|0.81|0.69
70874947|NCT02664441|141234305|SUPERIORITY||Mean Difference (Net)|-166.4||||0.004|TWO_SIDED|95.0|-269.7|-63.1|||Regression, Linear|Adjusted for baseline values||||-63.1|-269.7|0.004
70874948|NCT02664441|141234306|SUPERIORITY||Mean Difference (Net)|-145.0||||0.58|TWO_SIDED|95.0|-653.5|363.4|||Regression, Linear|Adjusted for baseline||||363.4|-653.5|0.58
70874949|NCT02664441|141234307|SUPERIORITY||Mean Difference (Net)|-8.5||||0.088|TWO_SIDED|95.0|-19.1|2.1|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) were used as covariates.||||2.1|-19.1|0.088
70874950|NCT03654651|141234315|SUPERIORITY||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-2.7|1.6|||Mixed Models Analysis|||||1.6|-2.7|
70874951|NCT03654651|141234315|OTHER|change from baseline|Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-2.7|0.9|||Mixed Models Analysis|||||0.9|-2.7|
70874952|NCT03654651|141234315|OTHER|Change from baseline|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.2|1.4|||Mixed Models Analysis|||||1.4|-2.2|
70874953|NCT03654651|141234316|SUPERIORITY||Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-4.8|3.4|||Mixed Models Analysis|||||3.4|-4.8|
70874954|NCT03654651|141234316|OTHER|change from baseline|Mean Difference (Final Values)|-4.0|||||TWO_SIDED|95.0|-5.1|5.4|||Mixed Models Analysis|||||5.4|-5.1|
70874955|NCT03654651|141234316|OTHER|change from baseline|Mean Difference (Final Values)|-3.8|||||TWO_SIDED|95.0|-5.1|5.4|||Mixed Models Analysis|||||5.4|-5.1|
70874956|NCT03654651|141234317|SUPERIORITY||Mean Difference (Final Values)|0.45|||||TWO_SIDED|95.0|-1.2|2.1|||Mixed Models Analysis|||||2.1|-1.2|
70874957|NCT03654651|141234317|OTHER|change from baseline|Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-1.5|1.0|||Mixed Models Analysis|||||1.0|-1.5|
70874958|NCT03654651|141234317|OTHER|change from baseline|Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-2.1|0.5|||Mixed Models Analysis|||||0.5|-2.1|
70874959|NCT03654651|141234318|SUPERIORITY||Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-3.1|4.6|||Mixed Models Analysis|||peripheral systolic BP||4.6|-3.1|
70874960|NCT03654651|141234318|SUPERIORITY||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-2.1|2.9|||Mixed Models Analysis|||peripheral diastolic BP||2.9|-2.1|
70874961|NCT03654651|141234318|OTHER|change from baseline|Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-2.5|3.3|||Mixed Models Analysis|||peripheral systolic BP change from baseline||3.3|-2.5|
71147502|NCT01684917|141788578|SUPERIORITY||||||<|0.05||||||calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||Baseline vs 12 weeks||||<0.05
71147503|NCT01684917|141788578|SUPERIORITY||||||<|0.05||||||calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|t-test, 2 sided|||Baseline vs 12 weeks||||<0.05
71147504|NCT01684917|141788579|SUPERIORITY|"Statistical Analysis was performed only for the Diet Arm/Group"|||||<|0.05||||||calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||"Baseline vs 12 weeks. Statistical Analysis was performed only for the Diet Arm/Group."||||<0.05
71147505|NCT01684917|141788580|SUPERIORITY|"Statistical Analysis was performed only for the Diet Arm/Group"|||||<|0.05||||||calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|t-test, 2 sided|||"Baseline vs 12 weeks. Statistical Analysis was performed only for the Diet Arm/Group."||||<0.05
71147506|NCT01684917|141788581|SUPERIORITY||||||<|0.05||||||The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||Baseline vs 12 weeks||||<0.05
71147507|NCT01684917|141788581|SUPERIORITY||||||<|0.05||||||The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||Baseline vs 12 weeks||||<0.05
71147508|NCT01684917|141788581|SUPERIORITY||||||<|0.05||||||The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||Baseline vs 12 weeks||||<0.05
71147509|NCT01684917|141788583|SUPERIORITY|"Statistical Analysis was performed only for the Diet Arm/Group"|||||<|0.05||||||calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||"Baseline vs 12 weeks. Statistical Analysis was performed only for the Diet Arm/Group."||||<0.05
71147510|NCT00459316|141788587|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||||||Two-sided p-value \<0.05 was specified as statistically significant a priori. There were no adjustments for multiple outcomes.|Fisher Exact|||The null hypothesis was that there would be no difference between CD4% strata.||||0.03
70874962|NCT03654651|141234318|OTHER|change from baseline|Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-3.1|2.6|||Mixed Models Analysis|||peripheral systolic BP change from baseline||2.6|-3.1|
70874963|NCT03654651|141234318|OTHER|change from baseline|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-1.5|2.5|||Mixed Models Analysis|||peripheral diastolic BP change from baseline||2.5|-1.5|
70874964|NCT03654651|141234318|OTHER|change from baseline|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Mixed Models Analysis|||peripheral diastolic BP change from baseline||2|-2|
70874965|NCT03654651|141234319|SUPERIORITY||Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.4|4.4|||Mixed Models Analysis|||central systolic BP||4.4|-2.4|
70874966|NCT03654651|141234319|SUPERIORITY||Mean Difference (Final Values)|0.8|||||TWO_SIDED|95.0|-1.7|3.3|||Mixed Models Analysis|||central diastolic BP||3.3|-1.7|
70874967|NCT03654651|141234319|OTHER|change from baseline|Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-1.9|3.1|||Mixed Models Analysis|||central systolic BP change from baseline||3.1|-1.9|
70874968|NCT03654651|141234319|OTHER|change from baseline|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.9|2.1|||Mixed Models Analysis|||central systolic BP change from baseline||2.1|-2.9|
70874969|NCT03654651|141234319|OTHER|change from baseline|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-1.5|2.6|||Mixed Models Analysis|||central diastolic BP change from baseline||2.6|-1.5|
70874970|NCT03654651|141234319|OTHER|change from baseline|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.4|1.6|||Mixed Models Analysis|||central diastolic BP change from baseline||1.6|-2.4|
70874971|NCT03654651|141234320|SUPERIORITY||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.1|0.5|||Mixed Models Analysis|||||0.5|-0.1|
71147511|NCT00459316|141788588|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||||||Two sided-p-value \<0.05 was specified as statistically significant a priori. No adjustment for multiple primary outcomes was made.|Fisher Exact|||The null hypothesis was that there were no differences between CD4% strata.||||0.01
71147512|NCT03044106|141788605|SUPERIORITY||Mean Difference (Final Values)|3.825|STANDARD_DEVIATION|3.308759||0.0068|TWO_SIDED|95.0|1.058809|6.591192|||t-test, 2 sided|||This is the difference between pre and post KEA in those receiving the active treatment with a history of hamstring strain.||6.591192|1.058809|0.0068
70874972|NCT03654651|141234320|OTHER|change from baseline|Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|0.1|0.6|||Mixed Models Analysis|||||0.6|0.1|
70874973|NCT03654651|141234320|OTHER|change from baseline|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.1|0.3|||Mixed Models Analysis|||||0.3|-0.1|
70874974|NCT03654651|141234321|SUPERIORITY||Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-5.9|3.3|||Mixed Models Analysis|||||3.3|-5.9|
70874975|NCT03654651|141234321|OTHER|change from baseline|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-3.7|2.9|||Mixed Models Analysis|||||2.9|-3.7|
70874976|NCT03654651|141234321|OTHER|change from baseline|Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-4.0|4.3|||Mixed Models Analysis|||||4.3|-4.0|
70874977|NCT03654651|141234322|SUPERIORITY||Mean Difference (Final Values)|4.3|||||TWO_SIDED|95.0|-1.4|9.8|||Mixed Models Analysis|||||9.8|-1.4|
70874978|NCT03654651|141234322|OTHER|change from baseline|Mean Difference (Final Values)|2.4|||||TWO_SIDED|95.0|-2.1|6.9|||Mixed Models Analysis|||||6.9|-2.1|
70874979|NCT03654651|141234322|OTHER|change from baseline|Mean Difference (Final Values)|-2.3|||||TWO_SIDED|95.0|-6.8|2.2|||Mixed Models Analysis|||||2.2|-6.8|
70874980|NCT03654651|141234323|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-2.3|2.3|||Mixed Models Analysis|||||2.3|-2.3|
71147513|NCT03044106|141788605|SUPERIORITY||Median Difference (Final Values)|1.0|STANDARD_DEVIATION|3.431784||0.2185|TWO_SIDED|95.0|-1.869044|3.869044|||t-test, 2 sided|||This is the difference in pre /post KEA means after receiving the sham treatment in those with a history of hamstring strains.||3.869044|-1.869044|0.2185
71147514|NCT03044106|141788605|SUPERIORITY||Mean Difference (Final Values)|0.6638904|STANDARD_DEVIATION|3.450892||0.1281|TWO_SIDED|95.0|-0.5037233|1.831504|||t-test, 2 sided|||This is the difference in pre/post KEA means in those receiving the active treatment with no history of hamstring strain.||1.831504|-.5037233|0.1281
70955728|NCT04797650|141415058|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.019||0.012|TWO_SIDED|95.0|0.01|0.09||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 12||0.09|0.01|0.012
70955729|NCT04797650|141415058|SUPERIORITY||Risk Difference (RD)|0.21|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.16|0.26||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 24||0.26|0.16|< 0.0001
70955730|NCT04797650|141415058|SUPERIORITY||Risk Difference (RD)|0.24|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.16|0.31||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 24||0.31|0.16|< 0.0001
70955731|NCT04797650|141415059|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|0.7|1.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.4|0.7|< 0.0001
70955732|NCT04797650|141415059|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|0.7|1.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.5|0.7|< 0.0001
70955733|NCT04797650|141415059|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|1.1|1.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||1.8|1.1|< 0.0001
70955734|NCT04797650|141415059|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|1.3|2.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2.2|1.3|< 0.0001
70955735|NCT04797650|141415060|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|0.7|1.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.5|0.7|< 0.0001
70955736|NCT04797650|141415060|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|0.7|1.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.6|0.7|< 0.0001
70955737|NCT04797650|141415060|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|1.0|2.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2|1|< 0.0001
70955738|NCT04797650|141415060|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|1.0|2.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2.1|1|< 0.0001
71147515|NCT03044106|141788605|SUPERIORITY||Mean Difference (Final Values)|2.688237|STANDARD_DEVIATION|3.241751||0|TWO_SIDED|95.0|1.557137|3.819337|||t-test, 2 sided|||This is the difference in pre/post KEA means in those receiving the sham treatment who have no history of hamstring strain.||3.819337|1.557137|0.00
70955739|NCT04797650|141415061|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-0.9|-1.4|< 0.0001
71147516|NCT03044106|141788605|SUPERIORITY||Mean Difference (Final Values)|2.825||||0.09|TWO_SIDED|95.0|-0.4543|6.0581|||Mixed Models Analysis|||This is the mean difference in effect between active and sham in those with a history of hamstring strain||6.0581|-0.4543|0.090
71147517|NCT03044106|141788605|SUPERIORITY||Mean Difference (Final Values)|-2.024||||0.018|TWO_SIDED|95.0|-3.4474|-0.3406|||Mixed Models Analysis|||This is the mean difference of effect between active and sham in those without a history of hamstring strain.||-0.3406|-3.4474|0.018
71147518|NCT00423579|141788620|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-14.5||||0||95.0|-18.9|-10.1|||Student's t test for independent data||Difference in percentage change in mean LDL-C values (change from baseline to week 6) between the two treatment groups. (Ezetimibe \[EZ\]/Simvastatin \[S\] \[10/20mg\] + S \[placebo\] group minus the EZ/S \[10mg/placebo\] + S \[40mg\] group)|||-10.1|-18.9|0.0000
70955740|NCT04797650|141415061|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.5|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-0.9|-1.5|< 0.0001
70955741|NCT04797650|141415061|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-1.1|-1.6|< 0.0001
70955742|NCT04797650|141415061|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.8|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-1.2|-1.8|< 0.0001
70955743|NCT04797650|141415061|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-1.1|-1.6|< 0.0001
70955744|NCT04797650|141415061|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-2.0|-1.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-1.4|-2|< 0.0001
70955745|NCT04797650|141415061|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.8|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-1.3|-1.8|< 0.0001
70955746|NCT04797650|141415061|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-2.1|-1.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-1.4|-2.1|< 0.0001
71147519|NCT02392637|141788621|SUPERIORITY|||||||0.62|||||||Log Rank|||||||0.62
71147520|NCT02392637|141788622|SUPERIORITY|||||||0.39|||||||Log Rank|||||||0.39
70874981|NCT03654651|141234323|OTHER|change from baseline|Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.6|1.8|||Mixed Models Analysis|||||1.8|-0.6|
70874982|NCT03654651|141234323|OTHER|change from baseline|Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-1.6|2.3|||Mixed Models Analysis|||||2.3|-1.6|
70874983|NCT03654651|141234324|SUPERIORITY||Mean Difference (Final Values)|2.2|||||TWO_SIDED|95.0|-3.8|8.2|||Mixed Models Analysis|||||8.2|-3.8|
70874984|NCT03654651|141234324|OTHER|change from baseline|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-4.9|5.1|||Mixed Models Analysis|||||5.1|-4.9|
70874985|NCT03654651|141234324|OTHER|change from baseline|Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-7.8|2.3|||Mixed Models Analysis|||||2.3|-7.8|
70874986|NCT03654651|141234325|SUPERIORITY||Mean Difference (Final Values)|-7.7|||||TWO_SIDED|95.0|-18.3|2.8|||Mixed Models Analysis|||||2.8|-18.3|
70874987|NCT03654651|141234325|OTHER|change from baseline|Mean Difference (Final Values)|-17.0|||||TWO_SIDED|95.0|-29.1|-4.8|||Mixed Models Analysis|||||-4.8|-29.1|
70874988|NCT03654651|141234325|OTHER|change from baseline|Mean Difference (Final Values)|-5.7|||||TWO_SIDED|95.0|-17.1|5.7|||Mixed Models Analysis|||||5.7|-17.1|
70874989|NCT03654651|141234326|SUPERIORITY||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|||||0.7|-0.3|
70874990|NCT03654651|141234326|OTHER|change from baseline|Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.1|1.5|||Mixed Models Analysis|||||1.5|-0.1|
70874991|NCT03654651|141234326|OTHER|change from baseline|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.5|0.5|||Mixed Models Analysis|||||0.5|-0.5|
70874992|NCT01702454|141234328|NON_INFERIORITY_OR_EQUIVALENCE|Criterion: The lower limit (LL) of the two-sided 95% Confidence Interval (CI) for the GMT ratio is above 1|Adjusted GMT ratio|8.97|||||TWO_SIDED|95.0|6.21|12.96|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for A/Christchurch strain at post-vaccination dose 1, the GMT ratio of Fluarix Quadrivalent Primed Group/Fluarix Quadrivalent Unprimed Group and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination log-10 titer and age as regressors.||12.96|6.21|
70874993|NCT01702454|141234328|NON_INFERIORITY_OR_EQUIVALENCE|Criterion: The lower limit (LL) of the two-sided 95% Confidence Interval (CI) for the GMT ratio is above 1|Adjusted GMT ratio|2.7|||||TWO_SIDED|95.0|1.81|4.02|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval|The adjusted GMT of HI antibodies for A/Victoria strain at post-vaccination dose 1, the GMT ratio of Fluarix Quadrivalent Primed Group/Fluarix Quadrivalent Unprimed Group and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination log-10 titer and age as regressors.||4.02|1.81|
70874994|NCT01702454|141234328|NON_INFERIORITY_OR_EQUIVALENCE|Criterion: The lower limit (LL) of the two-sided 95% Confidence Interval (CI) for the GMT ratio is above 1|Adjusted GMT ratio|3.94|||||TWO_SIDED|95.0|2.89|5.37|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for B/Brisbane strain at post-vaccination dose 1, the GMT ratio of Fluarix Quadrivalent Primed Group/Fluarix Quadrivalent Unprimed Group and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination log-10 titer and age as regressors.||5.37|2.89|
70874995|NCT01702454|141234328|NON_INFERIORITY_OR_EQUIVALENCE|Criterion: The lower limit (LL) of the two-sided 95% Confidence Interval (CI) for the GMT ratio is above 1|Adjusted GMT ratio|6.71|||||TWO_SIDED|95.0|5.21|8.63|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for B/Hub-Wuj strain at post-vaccination dose 1, the GMT ratio of Fluarix Quadrivalent Primed Group/Fluarix Quadrivalent Unprimed Group and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination log-10 titer and age as regressors.||8.63|5.21|
70874996|NCT01702454|141234330|NON_INFERIORITY_OR_EQUIVALENCE|SCR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in percentages|44.74|||||TWO_SIDED|95.0|35.87|52.84||||||To assess the immune response in terms of SCR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.||52.84|35.87|
70955747|NCT04797650|141415062|SUPERIORITY||Risk Difference (RD)|0.34|STANDARD_ERROR_OF_MEAN|0.046|<|0.0001|TWO_SIDED|95.0|0.25|0.43||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.43|0.25|< 0.0001
70874997|NCT01702454|141234330|NON_INFERIORITY_OR_EQUIVALENCE|SCR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in percentages|45.31|||||TWO_SIDED|95.0|36.58|53.3||||||To assess the immune response in terms of SCR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.||53.3|36.58|
70874998|NCT01702454|141234330|NON_INFERIORITY_OR_EQUIVALENCE|SCR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in percentages|37.86||||||95.0|28.83|46.26||||||To assess the immune response in terms of SCR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.||46.26|28.83|
70874999|NCT01702454|141234330|NON_INFERIORITY_OR_EQUIVALENCE|SCR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion|Difference in percentages|56.0||||||95.0|48.32|63.04||||||"To assess the immune response in terms of SCR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.~B/Hu-Wuj = B/Hubei-Wujiagang/158/2009 (Yamagata)"||63.04|48.32|
70955748|NCT04797650|141415062|SUPERIORITY||Risk Difference (RD)|0.43|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001|TWO_SIDED|95.0|0.33|0.54||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.54|0.33|< 0.0001
70955749|NCT04797650|141415062|SUPERIORITY||Risk Difference (RD)|0.43|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001|TWO_SIDED|95.0|0.35|0.51||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.51|0.35|< 0.0001
70955750|NCT04797650|141415062|SUPERIORITY||Risk Difference (RD)|0.47|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001|TWO_SIDED|95.0|0.37|0.57||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.57|0.37|< 0.0001
70875000|NCT01702454|141234332|NON_INFERIORITY_OR_EQUIVALENCE|SPR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in SPR|62.43|||||TWO_SIDED|95.0|55.27|68.89||||||To assess the immune response in terms of SPR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains||68.89|55.27|
71147521|NCT00001959|141788637|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||H0: GFR Decrease during baseline period and treatment period are same||||<0.01
71147522|NCT00001959|141788638|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||Kruskal-Wallis|||H0: Proteinuria during baseline and treatment periods are same||||0.16
71147523|NCT00664443|141788729|OTHER||Sensitivity|65.9|||||TWO_SIDED|95.0|63.5|68.2||||||||68.2|63.5|
71147524|NCT00664443|141788730|OTHER||Specificity|32.3|||||TWO_SIDED|95.0|29.0|35.9||||||||35.9|29.0|
71147525|NCT05523089|141788731|SUPERIORITY||Hodges-Lehmann estimator|-1.2||||0.039|TWO_SIDED|95.0|-5.7|0.0||alpha = 0.025 one-sided|Wilcoxon (Mann-Whitney)|||||0.0|-5.7|0.0390
71147526|NCT05523089|141788733|SUPERIORITY||Mean Difference (Net)|-1.4||||0.0185|TWO_SIDED|95.0|-2.9|0.0||alpha = 0.025 one-sided|Wilcoxon (Mann-Whitney)|||||-0.0|-2.9|0.0185
71147527|NCT05523089|141788735|SUPERIORITY|||||||0.0613||||||alpha = 0.025 one-sided|Gehan-Wilcoxon|||||||0.0613
71147528|NCT05523089|141788736|SUPERIORITY||Hodges-Lehmann estimator|0.0||||0.1587|TWO_SIDED|95.0|-2.4|0.0||alpha = 0.025 one-sided|Wilcoxon (Mann-Whitney)|||||0.0|-2.4|0.1587
71147529|NCT05523089|141788738|SUPERIORITY||Mean Difference (Net)|-1.1||||0.0236|TWO_SIDED|95.0|-2.0|-0.1||alpha = 0.025 one-sided|Wilcoxon (Mann-Whitney)|||||-0.1|-2.0|0.0236
71147530|NCT05523089|141788740|SUPERIORITY|||||||0.1282||||||alpha = 0.025 one-sided|Gehan-Wilcoxon|||||||0.1282
71147531|NCT05523089|141788741|SUPERIORITY||Mean Difference (Net)|-5.4||||0.2877|TWO_SIDED|95.0|-11.2|0.3||alpha = 0.025 one-sided|Wilcoxon (Mann-Whitney)|||||0.3|-11.2|0.2877
71147532|NCT05523089|141788743|SUPERIORITY||Mean Difference (Net)|-1.8||||0.2517|TWO_SIDED|95.0|-4.1|0.6||alpha = 0.025 one-sided|Wilcoxon (Mann-Whitney)|||||0.6|-4.1|0.2517
71147533|NCT05523089|141788747|SUPERIORITY|||||||0.9024||||||alpha = 0.025 one-sided|Gehan-Wilcoxon|||||||0.9024
71147534|NCT05523089|141788748|SUPERIORITY|||||||0.0248||||||alpha = 0.025 one-sided|Fisher Exact|||||||0.0248
71147535|NCT05523089|141788750|SUPERIORITY|||||||0.1224||||||alpha = 0.025 one-sided|Fisher Exact|||||||0.1224
70875001|NCT01702454|141234332|NON_INFERIORITY_OR_EQUIVALENCE|SPR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in SPR|47.4|||||TWO_SIDED|95.0|39.08|55.06||||||To assess the immune response in terms of SPR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.||55.06|39.08|
70955751|NCT04797650|141415062|SUPERIORITY||Risk Difference (RD)|0.42|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.34|0.5||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.5|0.34|< 0.0001
71147536|NCT05523089|141788752|SUPERIORITY|||||||0.1023||||||alpha = 0.025 one-sided|Fisher Exact|||||||0.1023
71147537|NCT05523089|141788754|SUPERIORITY|||||||0.1477||||||alpha = 0.025 one-sided|Fisher Exact|||||||0.1477
71147538|NCT05523089|141788756|SUPERIORITY|||||||0.1645||||||alpha = 0.025 one-sided|Fisher Exact|||||||0.1645
71147539|NCT01181349|141788794|SUPERIORITY_OR_OTHER||||||=|0.169|||||||Chi-square test or Fisher's Exact Test|||Cross tables were performed between TOF ratio and medications administered. Statistical significance was evaluated using Chi-square test or Fisher's Exact Test. All tests were performed at a significance level of 0.05.||||=0.169
71147540|NCT01181349|141788796|SUPERIORITY_OR_OTHER||||||=|0.01|||||||Chi-square test or Fisher's Exact Test|||Cross tables were performed between TOF ratio and medications administered. Statistical significance was evaluated using Chi-square test or Fisher's Exact Test. All tests were performed at a significance level of 0.05.||||=0.01
71147541|NCT01116986|141788799|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.954||||0.312|TWO_SIDED|95.0|0.871|1.045|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.045|.871|.312
71147542|NCT01116986|141788799|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.98||||0.664|TWO_SIDED|95.0|0.894|1.074|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.074|.894|.664
71147543|NCT01116986|141788799|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.989||||0.814|TWO_SIDED|95.0|0.903|1.084|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.084|.903|.814
71147544|NCT01116986|141788799|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.925||||0.093|TWO_SIDED|95.0|0.844|1.013|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.013|.844|.093
71147545|NCT01116986|141788799|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.983||||0.716|TWO_SIDED|95.0|0.898|1.077|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.077|.898|.716
71147546|NCT01116986|141788799|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.031||||0.511|TWO_SIDED|95.0|0.941|1.13|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.130|.941|.511
71147547|NCT01116986|141788800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.087||||0.341|TWO_SIDED|95.0|0.916|1.29|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Pre-Quit Nicotine Patch vs. Pre-Quit Nicotine Patch) would result in significantly higher abstinence at 16 weeks post-quit.||1.290|.916|.341
71147548|NCT01116986|141788800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.117||||0.207|TWO_SIDED|95.0|0.941|1.325|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Pre-Quit Nicotine Gum vs. Pre-Quit Nicotine Gum) would result in significantly higher abstinence at 16 weeks post-quit.||1.325|.941|.207
70875002|NCT01702454|141234332|NON_INFERIORITY_OR_EQUIVALENCE|SPR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion|Difference in SPR|56.68|||||TWO_SIDED|95.0|49.44|63.43||||||To assess the immune response in terms of SPR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.||63.43|49.44|
70875003|NCT01702454|141234332|NON_INFERIORITY_OR_EQUIVALENCE|SPR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in SPR|56.72|||||TWO_SIDED|95.0|49.41|63.49||||||"To assess the immune response in terms of SPR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.~B/Hu-Wuj = B/Hubei-Wujiagang/158/2009 (Yamagata)"||63.49|49.41|
70955752|NCT04797650|141415062|SUPERIORITY||Risk Difference (RD)|0.54|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|0.44|0.63||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.63|0.44|< 0.0001
71147549|NCT01116986|141788800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.196||||0.041|TWO_SIDED|95.0|1.008|1.42|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Counseling Before the Quit Attempt vs. Counseling Before the Quit Attempt) would result in significantly higher abstinence at 16 weeks post-quit.||1.420|1.008|.041
70955753|NCT04797650|141415062|SUPERIORITY||Risk Difference (RD)|0.44|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.36|0.52||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.52|0.36|< 0.0001
71147550|NCT01116986|141788800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.056||||0.536|TWO_SIDED|95.0|0.889|1.254|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., Minimal In-person Counseling During the Quit Attempt vs. Intensive In-person Counseling During the Quit Attempt) would result in significantly higher abstinence at 16 weeks post-quit.||1.254|.889|.536
70955754|NCT04797650|141415062|SUPERIORITY||Risk Difference (RD)|0.52|STANDARD_ERROR_OF_MEAN|0.051|<|0.0001|TWO_SIDED|95.0|0.42|0.62||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.62|0.42|< 0.0001
70955755|NCT04797650|141415063|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 12||-0.8|-1.2|< 0.0001
71147551|NCT01116986|141788800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.049||||0.587|TWO_SIDED|95.0|0.883|1.246|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., Minimal Phone Counseling During the Quit Attempt vs. Intensive Phone Counseling During the Quit Attempt) would result in significantly higher abstinence at 16 weeks post-quit.||1.246|.883|.587
71147552|NCT01116986|141788800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.078||||0.389|TWO_SIDED|95.0|0.909|1.278|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum vs. Long Term (26 Weeks) Postquit Nicotine Patch + Nicotine Gum) would result in significantly higher abstinence at 16 weeks post-quit.||1.278|.909|.389
71147553|NCT02492763|141788802|SUPERIORITY||Difference in Least Squares Means|-0.39||||0.126|TWO_SIDED|95.0|-0.88|0.11|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||0.11|-0.88|0.126
71147554|NCT02492763|141788802|SUPERIORITY||Difference in Least Squares Means|0.6||||0.017|TWO_SIDED|95.0|0.11|1.08|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||1.08|0.11|0.017
71147555|NCT02492763|141788802|SUPERIORITY||Difference in Least Squares Means|-0.61||||0.018|TWO_SIDED|95.0|-1.12|-0.1|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||-0.10|-1.12|0.018
71147556|NCT02492763|141788802|SUPERIORITY||Difference in Least Squares Means|0.37||||0.146|TWO_SIDED|95.0|-0.13|0.87|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||0.87|-0.13|0.146
71147557|NCT02492763|141788802|SUPERIORITY||Difference in the Least Squares Means|-0.98|||<|0.001|TWO_SIDED|95.0|-1.49|-0.48||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment|Longitudinal data analysis|||||-0.48|-1.49|<0.001
71147558|NCT02492763|141788805|SUPERIORITY||Difference in % vs Placebo|-2.3||||0.301|TWO_SIDED|95.0|-12.1|5.6|||Miettinen & Nurminen method|||||5.6|-12.1|0.301
71147559|NCT02492763|141788805|SUPERIORITY||Difference in % vs Placebo|2.2||||0.573|TWO_SIDED|95.0|-8.1|13.2|||Miettinen & Nurminen method|||||13.2|-8.1|0.573
71147560|NCT02492763|141788805|SUPERIORITY||Difference in % vs Liraglutide|-2.4||||0.295|TWO_SIDED|95.0|-12.4|5.5|||Miettinen & Nurminen method|||||5.5|-12.4|0.295
71147561|NCT02492763|141788805|SUPERIORITY||Difference in % vs Liraglutide|2.2||||0.587|TWO_SIDED|95.0|-8.4|13.2|||Miettinen & Nurminen method|||||13.2|-8.4|0.587
71147562|NCT02492763|141788806|SUPERIORITY||Difference in the LS Means vs. Placebo|6.9|||||TWO_SIDED|95.0|3.42|10.37|||||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||Longitudinal data analysis|10.37|3.42|
70955756|NCT04797650|141415063|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.4|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 12||-0.8|-1.4|< 0.0001
71147563|NCT02492763|141788806|SUPERIORITY||Difference in LS Means vs. Liraglutide|3.84|||||TWO_SIDED|95.0|0.35|7.33|||||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||Longitudinal data analysis|7.33|0.35|
71147564|NCT02492763|141788806|SUPERIORITY||Difference in LS Means vs. Placebo|7.7|||||TWO_SIDED|95.0|4.17|11.23|||||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||Longitudinal data analysis|11.23|4.17|
71147565|NCT02492763|141788806|SUPERIORITY||Difference in LS Means vs. Liraglutide|4.65|||||TWO_SIDED|95.0|1.11|8.19|||||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||Longitudinal data analysis|8.19|1.11|
71147566|NCT02492763|141788807|SUPERIORITY||Difference in Least Squares Means|-0.7||||0.285|TWO_SIDED|95.0|-2.0|0.6|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||0.6|-2.0|0.285
71147567|NCT02492763|141788807|SUPERIORITY||Difference in Least Squares Means|0.9||||0.183|TWO_SIDED|95.0|-0.4|2.2|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||2.2|-0.4|0.183
70875004|NCT03510884|141234369|SUPERIORITY|Bonferroni adjustment was applied to handle multiplicity for the comparison of each alirocumab dosing regimen group versus its placebo group for the primary efficacy endpoint.|LS mean difference|-43.3|STANDARD_ERROR_OF_MEAN|5.5|<|0.0001|TWO_SIDED|97.5|-56.0|-30.7||The threshold for statistical significance was 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per interactive voice response system (IVRS), time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline LDL-C value and Baseline value by time-point interaction. Comparison was performed using an appropriate contrast.||-30.7|-56.0|<0.0001
70875005|NCT03510884|141234369|SUPERIORITY|Bonferroni adjustment was applied to handle multiplicity for the comparison of each alirocumab dosing regimen group versus its placebo group for the primary efficacy endpoint.|LS mean difference|-33.8|STANDARD_ERROR_OF_MEAN|5.5|<|0.0001|TWO_SIDED|97.5|-46.4|-21.2||The threshold for statistical significance was 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline LDL-C value and Baseline value by time-point interaction. Comparison was performed using an appropriate contrast.||-21.2|-46.4|<0.0001
70955757|NCT04797650|141415063|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 16||-0.9|-1.3|< 0.0001
71147568|NCT02492763|141788807|SUPERIORITY||Difference in Least Squares Means|-1.8||||0.01|TWO_SIDED|95.0|-3.1|-0.4|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||-0.4|-3.1|0.010
71147569|NCT02492763|141788807|SUPERIORITY||Difference in Least Squares Means|-0.2||||0.811|TWO_SIDED|95.0|-1.5|1.2|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||1.2|-1.5|0.811
71147570|NCT02492763|141788807|SUPERIORITY||Difference in the Least Squares Means|-1.6||||0.018|TWO_SIDED|95.0|-2.9|-0.3||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment|Longitudinal data analysis|||||-0.3|-2.9|0.018
71147571|NCT02492763|141788808|SUPERIORITY||Difference in Least Squares Means|-8.6||||0.385|TWO_SIDED|95.0|-28.2|10.9|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||10.9|-28.2|0.385
71147572|NCT02492763|141788808|SUPERIORITY||Difference in Least Squares Means|29.1||||0.004|TWO_SIDED|95.0|9.7|48.6|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||48.6|9.7|0.004
71147573|NCT02492763|141788808|SUPERIORITY||Difference in Least Squares Means|-29.5||||0.004|TWO_SIDED|95.0|-49.6|-9.4|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||-9.4|-49.6|0.004
71147574|NCT02492763|141788808|SUPERIORITY||Difference in Least Squares Means|8.3||||0.416|TWO_SIDED|95.0|-11.7|28.2|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||28.2|-11.7|0.416
71147575|NCT02492763|141788808|SUPERIORITY||Difference in the Least Squares Means|-37.8|||<|0.001|TWO_SIDED|95.0|-57.5|-18.0||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment|Longitudinal data analysis|||||-18.0|-57.5|<0.001
71147576|NCT02492763|141788812|SUPERIORITY||Difference in Least Squares Means|-3.7||||0.151|TWO_SIDED|95.0|-8.8|1.4|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||1.4|-8.8|0.151
70875006|NCT03510884|141234370|SUPERIORITY|Hierarchical testing method was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported and independently for each dosing regimen. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level. Statistical significance of the primary endpoint was required before testing the first secondary endpoint for each dosing regimen independently.|LS mean difference|-45.5|STANDARD_ERROR_OF_MEAN|4.7|<|0.0001|TWO_SIDED|97.5|-56.3|-34.7||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline LDL-C value and Baseline value by time-point interaction. Comparison was performed using an appropriate contrast.||-34.7|-56.3|<0.0001
70955758|NCT04797650|141415063|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 16||-1.1|-1.6|< 0.0001
70955759|NCT04797650|141415063|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 20||-1|-1.5|< 0.0001
71147577|NCT02492763|141788812|SUPERIORITY||Difference in Least Squares Means|-1.1||||0.682|TWO_SIDED|95.0|-6.2|4.1|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||4.1|-6.2|0.682
71147578|NCT02492763|141788812|SUPERIORITY||Difference in Least Squares Means|-2.5||||0.344|TWO_SIDED|95.0|-7.7|2.7|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||2.7|-7.7|0.344
71147579|NCT02492763|141788812|SUPERIORITY||Difference in Least Squares Means|0.2||||0.948|TWO_SIDED|95.0|-5.0|5.4|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||5.4|-5.0|0.948
71147580|NCT02492763|141788812|SUPERIORITY||Difference in the Least Squares Means|-2.7||||0.306|TWO_SIDED|95.0|-7.8|2.5||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment|Longitudinal data analysis|||||2.5|-7.8|0.306
71147581|NCT02492763|141788813|SUPERIORITY||Difference in Least Squares Means|1.5||||0.347|TWO_SIDED|95.0|-1.7|4.8|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||4.8|-1.7|0.347
71147582|NCT02492763|141788813|SUPERIORITY||Difference in Least Squares Means|-0.1||||0.963|TWO_SIDED|95.0|-3.3|3.2|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||3.2|-3.3|0.963
71147583|NCT02492763|141788813|SUPERIORITY||Difference in Least Squares Means|1.4||||0.394|TWO_SIDED|95.0|-1.9|4.7|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||4.7|-1.9|0.394
71147584|NCT02492763|141788813|SUPERIORITY||Difference in Least Squares Means|-0.2||||0.905|TWO_SIDED|95.0|-3.5|3.1|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||3.1|-3.5|0.905
71147585|NCT02492763|141788813|SUPERIORITY||Difference in the Least Squares Means|1.6||||0.325|TWO_SIDED|95.0|-1.6|4.9|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||4.9|-1.6|0.325
71147586|NCT01337960|141788814|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Fisher Exact|||||||< 0.01
71147587|NCT01337960|141788815|SUPERIORITY_OR_OTHER||||||<|0.02|TWO_SIDED||||||Fisher Exact|||||||<.02
71147588|NCT01337960|141788816|SUPERIORITY_OR_OTHER||||||=|0.17|TWO_SIDED||||||Fisher Exact|||||||=0.17
71147589|NCT01337960|141788817|SUPERIORITY_OR_OTHER||||||=|0.35|TWO_SIDED||||||Fisher Exact|||||||=0.35
70955760|NCT04797650|141415063|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.9|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 20||-1.3|-1.9|< 0.0001
71147590|NCT01744977|141788919|NON_INFERIORITY_OR_EQUIVALENCE|With an assumed adherence proportion in the Control arm of 0.50, there is 80% power to detect a difference between Control and the intervention arms of 17% or more with 125 patients in each arm.||||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.300
71147591|NCT01744977|141788920|NON_INFERIORITY_OR_EQUIVALENCE|With an assumed adherence proportion in the Control arm of 0.50, there is 80% power to detect a difference between Control and the intervention arms of 17% or more with 125 patients in each arm.|Mean Difference (Final Values)|-0.7||||0.839|TWO_SIDED|95.0|-8.0|6.5||As measured at 12m|Mixed Models Analysis||This value summarizes the full 12 month period so Mean Difference (Final Values) is appropriate.|||6.5|-8.0|0.839
71147592|NCT04090203|141788927|SUPERIORITY||Percentage|75.0||||0.001|ONE_SIDED|95.0|40.0|||The test was performed at a one-sided significance level of 0.05.|Exact binomial test|The null hypothesis of the exact binomial test was that the percentage of patients who were successfully desensitized was less than or equal to 20%.|The percentage of successfully desensitized participants is presented with a one-sided 95% CI, obtained from the lower bound of the two-sided 90% Clopper-Pearson exact confidence interval.|The null hypothesis was that the percentage of patients who were successfully desensitized was less than or equal to 20%, and the alternative hypothesis was that this percentage was greater than 20%. Assuming 80% of study participants would be successfully desensitized, a sample size of 10 patients would provide greater than 90% power to reject the null hypothesis using a one-sided exact binomial test with a significance level of 0.05.|||40.0|0.001
71147593|NCT03418714|141788928|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||T test on the change in network activity across all networks, from before to after salvinorin A administration.||||.006
71147594|NCT03418714|141788929|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||T test on the change in within- and between-network connectivity across all values, from before to after salvinorin A administration.||||.001
71147595|NCT03879772|141788930|SUPERIORITY|||||||0.95|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way analysis of variance (ANOVA).||||0.95
71147596|NCT03879772|141788930|SUPERIORITY|||||||0.78|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.78
71147597|NCT03879772|141788930|SUPERIORITY|||||||0.98|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.98
71147598|NCT03879772|141788930|SUPERIORITY|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.01
71147599|NCT03879772|141788930|SUPERIORITY|||||||0.82|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.82
70955761|NCT04797650|141415063|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 24||-1.1|-1.6|< 0.0001
71147600|NCT03879772|141788930|SUPERIORITY|||||||0.98|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.98
71147601|NCT03879772|141788930|SUPERIORITY|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.01
71147602|NCT03879772|141788930|SUPERIORITY|||||||0.8|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.8
71147603|NCT03879772|141788930|SUPERIORITY|||||||0.02|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.02
71147604|NCT03879772|141788930|SUPERIORITY|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.01
71147605|NCT03879772|141788931|SUPERIORITY|||||||0.56|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.56
71147606|NCT03879772|141788931|SUPERIORITY|||||||0.74|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.74
71147607|NCT03879772|141788931|SUPERIORITY|||||||0.68|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.68
71147608|NCT03879772|141788931|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
71147609|NCT03879772|141788931|SUPERIORITY|||||||0.81|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.81
70875007|NCT03510884|141234370|SUPERIORITY|A hierarchical testing method was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported and independently for each dosing regimen. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level. Statistical significance of the primary endpoint was required before testing the first secondary endpoint for each dosing regimen independently.|LS mean difference|-41.5|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001|TWO_SIDED|97.5|-52.7|-30.2||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline LDL-C value and Baseline value by time-point interaction. Comparison was performed using an appropriate contrast.||-30.2|-52.7|<0.0001
70875008|NCT03510884|141234371|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-37.8|STANDARD_ERROR_OF_MEAN|4.2|<|0.0001|TWO_SIDED|97.5|-47.5|-28.2||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Apo B value and Baseline Apo B value by time-point interaction. Comparison was performed using an appropriate contrast.||-28.2|-47.5|<0.0001
70875009|NCT03510884|141234371|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-30.7|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001|TWO_SIDED|97.5|-42.0|-19.4||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Apo B value and Baseline Apo B value by time-point interaction. Comparison was performed using an appropriate contrast.||-19.4|-42.0|<0.0001
70875010|NCT03510884|141234372|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-40.7|STANDARD_ERROR_OF_MEAN|5.0|<|0.0001|TWO_SIDED|97.5|-52.2|-29.1||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline non-HDL-C value and Baseline non-HDL-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-29.1|-52.2|<0.0001
70955762|NCT04797650|141415063|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.8|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 24||-1.2|-1.8|< 0.0001
71147610|NCT03879772|141788931|SUPERIORITY|||||||0.33|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.33
71147611|NCT03879772|141788931|SUPERIORITY|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.01
71147612|NCT03879772|141788931|SUPERIORITY|||||||0.46|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.46
71147613|NCT03879772|141788931|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
71147614|NCT03879772|141788931|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
71147615|NCT03879772|141788932|SUPERIORITY|||||||0.8|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.8
71147616|NCT03879772|141788932|SUPERIORITY|||||||0.45|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.45
71147617|NCT03879772|141788932|SUPERIORITY|||||||0.12|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.12
71147618|NCT03879772|141788932|SUPERIORITY|||||||0.36|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.36
71147619|NCT03879772|141788932|SUPERIORITY|||||||0.6|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.6
71147620|NCT03879772|141788932|SUPERIORITY|||||||0.17|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.17
71147621|NCT03879772|141788932|SUPERIORITY|||||||0.23|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.23
71147622|NCT03879772|141788932|SUPERIORITY|||||||0.42|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.42
71147623|NCT03879772|141788932|SUPERIORITY|||||||0.09|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.09
71147624|NCT03879772|141788932|SUPERIORITY|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.01
71147625|NCT03879772|141788933|SUPERIORITY|||||||0.03|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.03
71147626|NCT03879772|141788933|SUPERIORITY|||||||0.04|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.04
71147627|NCT03879772|141788933|SUPERIORITY|||||||0.08|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.08
71147628|NCT03879772|141788933|SUPERIORITY|||||||0.49|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.49
71147629|NCT03879772|141788933|SUPERIORITY|||||||0.93|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.93
71147630|NCT03879772|141788933|SUPERIORITY|||||||0.75|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.75
70955763|NCT04797650|141415063|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 12||-0.7|-1.1|< 0.0001
70955764|NCT04797650|141415063|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 12||-0.8|-1.3|< 0.0001
71147631|NCT03879772|141788933|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
71147632|NCT03879772|141788933|SUPERIORITY|||||||0.71|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.71
71147633|NCT03879772|141788933|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
71147634|NCT03879772|141788933|SUPERIORITY|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.01
71147635|NCT03879772|141788934|SUPERIORITY|||||||0.16|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.16
71147636|NCT03879772|141788934|SUPERIORITY|||||||0.22|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.22
71147637|NCT03879772|141788934|SUPERIORITY|||||||0.14|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.14
71147638|NCT03879772|141788934|SUPERIORITY|||||||0.14|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.14
71147639|NCT03879772|141788934|SUPERIORITY|||||||0.85|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.85
71147640|NCT03879772|141788934|SUPERIORITY|||||||0.96|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.96
71147641|NCT03879772|141788934|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
71147642|NCT03879772|141788934|SUPERIORITY|||||||0.81|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.81
71147643|NCT03879772|141788934|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
70955765|NCT04797650|141415063|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 16||-0.7|-1.2|< 0.0001
71147644|NCT03879772|141788934|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
71147645|NCT03879772|141788935|SUPERIORITY|||||||0.05|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.05
71147646|NCT03879772|141788935|SUPERIORITY|||||||0.07|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.07
71147647|NCT03879772|141788935|SUPERIORITY|||||||0.11|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.11
71147648|NCT03879772|141788935|SUPERIORITY|||||||0.31|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.31
71147649|NCT03879772|141788935|SUPERIORITY|||||||0.94|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.94
71147650|NCT03879772|141788935|SUPERIORITY|||||||0.73|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.73
71147651|NCT03879772|141788935|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
71147652|NCT03879772|141788935|SUPERIORITY|||||||0.79|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.79
71147653|NCT03879772|141788935|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
71147654|NCT03879772|141788935|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
71147655|NCT00106704|141788941|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-90.0|-0.57|||ANCOVA|Model terms: treatment, stratum (on metformin or not), baseline A1C||||-0.57|-90.0|<0.001
71147656|NCT00106704|141788942|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.1|STANDARD_ERROR_OF_MEAN|4.2|<|0.001|TWO_SIDED|95.0|-28.4|-11.8|||ANCOVA|Model terms: treatment, stratum (on metformin or not at Visit 3), baseline A1C||||-11.8|-28.4|<0.001
71147657|NCT00871975|141788968|SUPERIORITY_OR_OTHER||Sensitivity (percent)|80.6|||||TWO_SIDED||||||||We found an 80.6% sensitivity for detection of detrusor overactivity on Tetra-NIRS as compared to urodynamics.|A contingency table was used to compare presence or absence of an event (eg. detrusor overactivity) on the urodynamic tracing with interpretation of events on the Tetra-NIRS tracings.||||
71147658|NCT00871975|141788968|SUPERIORITY_OR_OTHER||Specificity (percent)|28.1|||||TWO_SIDED||||||||We found a 28.1% specificity for detection of detrusor overactivity on Tetra-NIRS as compared to urodynamics.|A contingency table was used to compare presence or absence of an event (eg. detrusor overactivity) on the urodynamic tracing with interpretation of events on the Tetra-NIRS tracings.||||
71147659|NCT02668653|141788981|OTHER||Hazard Ratio (HR)|0.776||||0.0324|TWO_SIDED|95.0|0.615|0.979|||Log Rank|Stratification factors include region, age, and WBC count at the time of diagnosis of AML.||||0.979|0.615|0.0324
71147660|NCT00979940|141788991|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Chi-squared|||||||0.97
71147661|NCT01294553|141788993|SUPERIORITY_OR_OTHER||Percentage of participants|15.4|||||TWO_SIDED|95.0|12.8|18.1|||||The estimated value represents the percentage of participants with an adverse event.|||18.1|12.8|
71147662|NCT00926237|141789005|SUPERIORITY||Mean Difference (Final Values)|-5.74||||0.04|ONE_SIDED|||||t value = -1.40|Mixed Models Analysis||1Hz active rTMS - Sham rTMS|||||.04
71147663|NCT00926237|141789005|SUPERIORITY||Mean Difference (Final Values)|-6.77||||0.02|ONE_SIDED|||||t value = -2.03|Mixed Models Analysis||10 Hz active rTMS - Sham rTMS|||||.02
71147664|NCT00926237|141789005|SUPERIORITY||Mean Difference (Final Values)|-4.73||||0.2|ONE_SIDED|||||t value = -1..28|Mixed Models Analysis||10 Hz washout - sham washout period|||||.20
71147665|NCT00926237|141789005|SUPERIORITY||Mean Difference (Final Values)|-5.19||||0.19|ONE_SIDED|||||t value = -1.29|Mixed Models Analysis||1Hz washout - sham washout|||||.19
71147666|NCT00632229|141789012|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||To evaluate between-group continuous outcomes of the pilot controlled trial, ANCOVAs were performed, where 8-week outcome scores were predicted by treatment condition while covarying for baseline scores.||||<0.05
71147667|NCT00632229|141789013|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||To evaluate between-group continuous outcomes of the pilot controlled trial, ANCOVAs were performed, where 8-week outcome scores were predicted by treatment condition while covarying for baseline scores.||||<0.05
71147668|NCT05386329|141789015|SUPERIORITY|Comparison of mid-treatment to end-of-treatment|Mean Difference (Final Values)|1.0308|STANDARD_ERROR_OF_MEAN|0.5485|=|0.0719|TWO_SIDED|95.0|-0.09883|2.1605||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an unstructured covariance matrix.|The effect is presented as the therapist-guided smartphone-delivered CBT midpoint (week 4) CSQ-8 score compared to the end-point (week 8) CSQ-8 score.|Null hypothesis: there is no significant difference in CSQ-8 total scores between midpoint (week 4) and end-of-treatment (week 8).||2.1605|-0.09883|=.0719
71147669|NCT05386329|141789016|SUPERIORITY|Comparison of mid-treatment (week 4) to baseline|Mean Difference (Final Values)|0.4296|STANDARD_ERROR_OF_MEAN|0.8857|=|0.6316|TWO_SIDED|95.0|-1.3884|2.2475||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an unstructured covariance matrix.|The effect is presented as the therapist-guided smartphone-delivered CBT midpoint (week 4) CEQ credibility score compared to the baseline (week 0) CEQ credibility score.|Null hypothesis: there is no significant difference in treatment credibility total scores between baseline (week 0) and midpoint (week 4).||2.2475|-1.3884|=.6316
70875011|NCT03510884|141234372|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-31.9|STANDARD_ERROR_OF_MEAN|5.3|<|0.0001|TWO_SIDED|97.5|-44.1|-19.7||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline non-HDL-C value and Baseline non-HDL-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-19.7|-44.1|<0.0001
70875012|NCT03510884|141234373|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-30.8|STANDARD_ERROR_OF_MEAN|3.9|<|0.0001|TWO_SIDED|97.5|-39.8|-21.9||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Total-C value and Baseline Total-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-21.9|-39.8|<0.0001
70875013|NCT03510884|141234373|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-23.3|STANDARD_ERROR_OF_MEAN|4.4|<|0.0001|TWO_SIDED|97.5|-33.5|-13.1||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Total-C value and Baseline Total-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-13.1|-33.5|<0.0001
70875014|NCT03510884|141234374|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-38.9|STANDARD_ERROR_OF_MEAN|4.0|<|0.0001|TWO_SIDED|97.5|-48.2|-29.6||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Apo B value and Baseline Apo B value by time-point interaction. Comparison was performed using an appropriate contrast.||-29.6|-48.2|<0.0001
70875015|NCT03510884|141234374|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-32.8|STANDARD_ERROR_OF_MEAN|4.3|<|0.0001|TWO_SIDED|97.5|-42.8|-22.7|||MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Apo B value and Baseline Apo B value by time-point interaction. Comparison was performed using an appropriate contrast.||-22.7|-42.8|<0.0001
70955766|NCT04797650|141415063|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 16||-0.9|-1.4|< 0.0001
70955767|NCT04797650|141415063|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 20||-0.9|-1.3|< 0.0001
70955768|NCT04797650|141415063|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 20||-1.1|-1.6|< 0.0001
71147670|NCT05386329|141789017|SUPERIORITY|Comparison of mid-treatment (week 4) to baseline.|Mean Difference (Final Values)|1.1512|STANDARD_ERROR_OF_MEAN|0.9213|=|0.2225|TWO_SIDED|95.0|-0.7422|3.0446||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an unstructured covariance matrix.|The effect is presented as the therapist-guided smartphone-delivered CBT midpoint (week 4) CEQ expectancy scores compared to the baseline (week 0) CEQ expectancy scores.|Null hypothesis: there is no significant difference in treatment expectancy total scores between baseline (week 0) and midpoint (week 4).||3.0446|-0.7422|=.2225
70875016|NCT03510884|141234375|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-42.8|STANDARD_ERROR_OF_MEAN|4.7|<|0.0001|TWO_SIDED|97.5|-53.8|-31.8||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Non-HDL-C value and Baseline Non-HDL-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-31.8|-53.8|<0.0001
70875017|NCT03510884|141234375|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-37.5|STANDARD_ERROR_OF_MEAN|4.5|<|0.0001|TWO_SIDED|97.5|-47.9|-27.0||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline non-HDL-C value and Baseline non-HDL-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-27.0|-47.9|<0.0001
70875018|NCT03510884|141234376|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-32.7|STANDARD_ERROR_OF_MEAN|3.7|<|0.0001|TWO_SIDED|97.5|-41.3|-24.2||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Total-C value and Baseline Total-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-24.2|-41.3|<0.0001
70875019|NCT03510884|141234376|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-27.9|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|97.5|-35.6|-20.2||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Total-C value and Baseline Total-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-20.2|-35.6|<0.0001
70875020|NCT03510884|141234377|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|77.6|||=|0.0001|TWO_SIDED|97.5|6.3|960.0||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q2W versus Placebo Q2W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. Logistic regression model stratified by randomization factors (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||960.0|6.3|=0.0001
70875021|NCT03510884|141234377|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|14.9|||<|0.0001|TWO_SIDED|97.5|3.2|69.8||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q4W versus Placebo Q4W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. Logistic regression model stratified by randomization factors (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||69.8|3.2|<0.0001
70875022|NCT03510884|141234378|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|26.5|||<|0.0001|TWO_SIDED|97.5|4.0|174.8||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q2W versus Placebo Q2W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. The logistic regression model stratified by randomization factors (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||174.8|4.0|<0.0001
70955769|NCT04797650|141415063|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 24||-1.0|-1.5|< 0.0001
70955770|NCT04797650|141415063|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.8|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 24||-1.2|-1.8|< 0.0001
71147671|NCT05386329|141789019|SUPERIORITY|Comparison of post-treatment (week 8) to mid-treatment (week 4)|Wilcoxon Z|0.2712|||=|0.7873|TWO_SIDED|||||The a priori threshold for statistical significance was alpha=.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no significant difference in treatment utilization between midpoint (week 4) and end of treatment (week 8).||||=.7873
71147672|NCT05386329|141789020|SUPERIORITY|Pre-post comparison|Mean Difference (Final Values)|-7.8424|STANDARD_ERROR_OF_MEAN|1.2858|<|0.0001|TWO_SIDED|95.0|-10.4944|-5.1903||The p-value was not adjusted for multiple comparisons because this was the pre-specified primary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an unstructured covariance matrix.|The effect is presented as the therapist-guided smartphone-delivered CBT end of treatment (week 8) HAM-D score compared to the baseline (week 0) HAM-D score.|Null hypothesis: there is no significant difference in HAM-D total scores between baseline (week 0) and end of treatment (week 8).||-5.1903|-10.4944|<.0001
71147673|NCT05386329|141789021|SUPERIORITY|Pre-post comparison|Mean Difference (Final Values)|-9.9409|STANDARD_ERROR_OF_MEAN|1.7329|<|0.0001|TWO_SIDED|95.0|-13.5043|-6.3776||The p-value was not adjusted for multiple comparisons because this was the pre-specified secondary outcome that addresses complementary aspects of the patient experience. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an unstructured covariance matrix.|The effect is presented as the therapist-guided smartphone-delivered CBT end of treatment (week 8) WSAS scores compared to the baseline (week 0) WSAS scores.|Null hypothesis: there is no significant difference in WSAS total scores between baseline (week 0) and end of treatment (week 8).||-6.3776|-13.5043|<.0001
71147674|NCT05386329|141789022|SUPERIORITY|Pre-post comparison|Mean Difference (Final Values)|21.5463|STANDARD_ERROR_OF_MEAN|3.4152|<|0.0001|TWO_SIDED|95.0|14.512|28.5806||The p-value was not adjusted for multiple comparisons because this was a pre-specified secondary outcome assessing a complementary aspect of the patient experience. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an unstructured covariance matrix.|The effect is presented as the therapist-guided smartphone-delivered CBT end of treatment (week 8) Q-LES-Q-SF percent scores compared to the baseline (week 0) Q-LES-Q-SF percent scores.|Null hypothesis: there is no significant difference in Q-LES-Q-SF total scores between baseline (week 0) and end of treatment (week 8).||28.5806|14.5120|<.0001
70875023|NCT03510884|141234378|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|40.9|||<|0.0001|TWO_SIDED|97.5|5.7|290.9||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q4W versus Placebo Q4W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. The logistic regression model stratified by randomization factors (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||290.9|5.7|<0.0001
70875024|NCT03510884|141234379|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|52.7|||=|0.0011|TWO_SIDED|97.5|3.5|804.3||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q2W versus Placebo Q2W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. The logistic regression model stratified by randomization factors (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||804.3|3.5|=0.0011
70875025|NCT03510884|141234379|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|43.1|||=|0.0006|TWO_SIDED|97.5|3.7|498.6||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q4W versus Placebo Q4W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. The logistic regression model stratified by randomization factors (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||498.6|3.7|=0.0006
70875026|NCT03510884|141234380|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|41.3|||<|0.0001|TWO_SIDED|97.5|6.6||The percentage of participants reaching LDL-C level lower than 110 mg/dL was 0% in the placebo arm, as a result it was possible to derive the estimated odds-ratio, but the estimated confidence interval (CI) was very wide, with the upper limit estimated to Infinity, therefore upper limit of 97.5% CI was not available to report.|Threshold for significance at 0.025 level.|Exact conditional logistic regression||Alirocumab Q2W versus Placebo Q2W: Odds ratios and confidence intervals estimated from exact conditional logistic regression model.|The LOCF approach followed by exact conditional logistic regression model. The exact conditional logistic regression model stratified by randomization factors (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the quartiles of the Baseline LDL-C value.|||6.6|<0.0001
70875027|NCT03510884|141234380|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|104.8|||=|0.0005|TWO_SIDED|97.5|5.2|2095.9||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q4W versus Placebo Q4W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. The logistic regression model stratified by randomization factors (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||2095.9|5.2|=0.0005
70955771|NCT04797650|141415063|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 12||-0.8|-1.3|< 0.0001
70955772|NCT04797650|141415063|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.4|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 12||-0.8|-1.4|< 0.0001
70955773|NCT04797650|141415063|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 16||-0.8|-1.3|< 0.0001
70955774|NCT04797650|141415063|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 16||-1|-1.6|< 0.0001
70955775|NCT04797650|141415063|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 20||-1.0|-1.5|< 0.0001
70955776|NCT04797650|141415063|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.7|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 20||-1.1|-1.7|< 0.0001
70955777|NCT04797650|141415063|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 24||-1.0|-1.5|< 0.0001
70955778|NCT04797650|141415063|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.8|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 24||-1.2|-1.8|< 0.0001
70955779|NCT04797650|141415063|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 12||-0.7|-1.1|< 0.0001
70955780|NCT04797650|141415063|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 12||-0.7|-1.2|< 0.0001
70955781|NCT04797650|141415063|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 16||-0.7|-1.2|< 0.0001
70955782|NCT04797650|141415063|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 16||-0.8|-1.3|< 0.0001
70875028|NCT03510884|141234381|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Adjusted mean difference|-15.2|STANDARD_ERROR_OF_MEAN|6.7|=|0.0237|TWO_SIDED|97.5|-30.3|-0.1||Threshold for significance at 0.025 level.|Robust regression model||Alirocumab Q2W versus Placebo Q2W|Multiple imputation approach followed by robust regression model. The robust regression model included the fixed categorical effect of treatment group and randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS and the continuous fixed covariate of Baseline lipoprotein (a) value.||-0.1|-30.3|=0.0237
70875029|NCT03510884|141234381|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Adjusted mean difference|-24.9|STANDARD_ERROR_OF_MEAN|8.7|=|0.0043|TWO_SIDED|97.5|-44.4|-5.4||Threshold for significance at 0.025 level.|Robust regression model||Alirocumab Q4W versus Placebo Q4W|Multiple imputation approach followed by robust regression model. The robust regression model included the fixed categorical effect of treatment group and randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS and the continuous fixed covariate of Baseline lipoprotein (a) value.||-5.4|-44.4|=0.0043
70955783|NCT04797650|141415063|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 20||-0.8|-1.3|< 0.0001
70955784|NCT04797650|141415063|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 20||-1.0|-1.5|< 0.0001
71147675|NCT02667119|141789028|SUPERIORITY||F|4.75||||0.041|TWO_SIDED||||||ANCOVA|Controlled for baseline scores on the National Stressful Events PTSD Scale||Compared the two groups at 3 months post-baseline||||.041
71147676|NCT02667119|141789029|SUPERIORITY||F|6.89||||0.016|TWO_SIDED||||||ANCOVA|Controlled for baseline score on the National Stressful Events PTSD Scale||||||.016
71147677|NCT02667119|141789030|SUPERIORITY||t|-2.19||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||.04
71147678|NCT02667119|141789031|SUPERIORITY||F|2.25||||0.148|TWO_SIDED|||||Controlling for baseline score on the Center for Epidemiological Studies-Depressed Mood scale|ANCOVA|||||||.148
71147679|NCT02667119|141789032|SUPERIORITY||F|4.64||||0.043|TWO_SIDED||||||ANCOVA|Controlling for baseline score on the Center for Epidemiological Studies-Depressed Mood scale||||||.043
71147680|NCT02667119|141789033|SUPERIORITY||F|1.4||||0.25|TWO_SIDED|||||Controlling for baseline score on the Quality of Life Scale|ANCOVA|||||||.250
71147681|NCT02667119|141789034|SUPERIORITY||F|0.45||||0.508|TWO_SIDED||||||ANCOVA|Controlling for baseline score on the Quality of Life Scale||||||.508
71147682|NCT02059278|141789047|EQUIVALENCE|Analysis at 8 am on Day 15|Mean Difference (Final Values)|0.781||||0.0091|TWO_SIDED|95.0|0.195|1.366|||ANCOVA||ANCOVA on change from baseline at 8 am on Day 15|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.366|0.195|0.0091
71147683|NCT02059278|141789047|EQUIVALENCE|Analysis at 10 am on Day 15|Mean Difference (Final Values)|0.664||||0.0098|TWO_SIDED|95.0|0.161|1.167|||ANCOVA||ANCOVA on change from baseline at 10 am on Day 15|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.167|0.161|0.0098
71147684|NCT02059278|141789047|EQUIVALENCE|Analysis at 4 pm on Day 15|Mean Difference (Final Values)|0.542||||0.0398|TWO_SIDED|95.0|0.025|1.058|||ANCOVA||ANCOVA on change from baseline at 4 pm on Day 15|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.058|0.025|0.0398
71147685|NCT02059278|141789047|EQUIVALENCE|Analysis at 8 am on Day 42|Mean Difference (Final Values)|0.478||||0.1008|TWO_SIDED|95.0|-0.093|1.05|||ANCOVA||ANCOVA on change from baseline at 8 am on Day 42|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.050|-0.093|0.1008
71147686|NCT02059278|141789047|EQUIVALENCE|Analysis at 10 am on Day 42|Mean Difference (Final Values)|0.505||||0.0558|TWO_SIDED|95.0|-0.013|1.024|||ANCOVA||ANCOVA on change from baseline at 10 am on Day 42|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.024|-0.013|0.0558
71147687|NCT02059278|141789047|EQUIVALENCE|Analysis at 4 pm on Day 42|Mean Difference (Final Values)|0.538||||0.0491|TWO_SIDED|95.0|0.002|1.074|||ANCOVA||ANCOVA on change from baseline at 4 pm on Day 42|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.074|0.002|0.0491
71147688|NCT02059278|141789047|EQUIVALENCE|Analysis at 8 am on Day 84|Mean Difference (Final Values)|0.808||||0.0025|TWO_SIDED|95.0|0.286|1.329|||ANCOVA||ANCOVA on change from baseline at 8 am on Day 84|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.329|0.286|0.0025
70955785|NCT04797650|141415063|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 24||-0.9|-1.4|< 0.0001
70955786|NCT04797650|141415063|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 24||-1.1|-1.6|< 0.0001
70955787|NCT04797650|141415064|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.29||0.1206|TWO_SIDED|95.0|-0.1|1.0||P-value was calculated by analysis of covariance (ANCOVA) analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Anxiety||1.0|-0.1|0.1206
70955788|NCT04797650|141415064|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.34||0.5367|TWO_SIDED|95.0|-0.5|0.9||P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Anxiety||0.9|-0.5|0.5367
70955789|NCT04797650|141415064|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.29||0.0064|TWO_SIDED|95.0|0.2|1.3||P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Depression||1.3|0.2|0.0064
70955790|NCT04797650|141415064|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.33||0.0011|TWO_SIDED|95.0|0.4|1.7||P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Depression||1.7|0.4|0.0011
70955791|NCT04797650|141415065|SUPERIORITY||Risk Difference (RD)|0.24|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.19|0.3||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.3|0.19|< 0.0001
71147689|NCT02059278|141789047|EQUIVALENCE|Analysis at 10 am on Day 84|Mean Difference (Final Values)|0.627||||0.0113|TWO_SIDED|95.0|0.143|1.111|||ANCOVA||ANCOVA on change from baseline at 10 am on Day 84|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.111|0.143|0.0113
70955792|NCT04797650|141415065|SUPERIORITY||Risk Difference (RD)|0.25|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|0.18|0.33||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.33|0.18|< 0.0001
70955793|NCT00657020|141415066|SUPERIORITY_OR_OTHER|||||||0.296||95.0|||||ANOVA|||Region of Interest is left anterior insula.||||0.2960
70955794|NCT00657020|141415066|SUPERIORITY_OR_OTHER|||||||0.345||95.0|||||ANOVA|||Region of interest is left anterior insula.||||0.3450
70955795|NCT00657020|141415066|SUPERIORITY_OR_OTHER|||||||0.1192||95.0|||||ANOVA|||Region of interest is left anterior putamen.||||0.1192
70955796|NCT00657020|141415066|SUPERIORITY_OR_OTHER|||||||0.6639||95.0|||||ANOVA|||Region of interest is left anterior putamen.||||0.6639
71147690|NCT02059278|141789047|EQUIVALENCE|Analysis at 4 pm on Day 84|Mean Difference (Final Values)|0.456||||0.0649|TWO_SIDED|95.0|-0.063|0.975|||ANCOVA||ANCOVA on change from baseline at 4 pm on Day 84|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||0.975|-0.063|0.0649
71147691|NCT00737672|141789056|SUPERIORITY_OR_OTHER|||||||0.53|||||||Log Rank|||||||0.530
71147692|NCT00737672|141789059|SUPERIORITY_OR_OTHER|||||||0.475|||||||Log Rank|||||||0.475
70955797|NCT00657020|141415066|SUPERIORITY_OR_OTHER|||||||0.8295||95.0|||||ANOVA|||Region of interest is left dorsal anterior cingulate cortex.||||0.8295
71147693|NCT00737672|141789062|SUPERIORITY_OR_OTHER|||||||0.008||||||P-value was calculated using Kaplan-Meier methodology with 24-month follow-up data.|Log Rank|||||||0.008
71147694|NCT00737672|141789063|NON_INFERIORITY_OR_EQUIVALENCE|One-sided test of non-inferior proportions with delta = 0.15.|||||<|0.001|||||||Z-test|One-sided.||||||<0.001
70955798|NCT00657020|141415066|SUPERIORITY_OR_OTHER|||||||0.0078||95.0|||||ANOVA|||Region of interest is left dorsal anterior cingulate cortex.||||0.0078
70955799|NCT00657020|141415066|SUPERIORITY_OR_OTHER|||||||0.7153||95.0|||||ANOVA|||Region of interest is left dorsolateral pre-frontal cortex.||||0.7153
70955800|NCT00657020|141415066|SUPERIORITY_OR_OTHER|||||||0.8511||95.0|||||ANOVA|||Region of interest is left dorsolateral pre-frontal cortex||||0.8511
70955801|NCT00657020|141415066|SUPERIORITY_OR_OTHER|||||||0.4228||95.0|||||ANOVA|||Region of interest is left parietal cortex||||0.4228
70955802|NCT00657020|141415066|SUPERIORITY_OR_OTHER|||||||0.0611||95.0|||||ANOVA|||Region of interest is left parietal cortex||||0.0611
70955803|NCT00657020|141415066|SUPERIORITY_OR_OTHER|||||||0.9879||95.0|||||ANOVA|||Region of interest is left premotor cortex||||0.9879
71147695|NCT00737672|141789064|SUPERIORITY_OR_OTHER|||||||0.035|||||||Log Rank|||||||0.035
71147696|NCT00737672|141789067|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|Two-tailed.||||||1.000
71147697|NCT00737672|141789068|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|Two-tailed.||||||<0.001
71147698|NCT00737672|141789069|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|Two-tailed.||||||<0.001
71147699|NCT04825678|141789122|OTHER||Least squares mean (LSM)|40.72|STANDARD_ERROR_OF_MEAN|2.37|<|0.001|TWO_SIDED|95.0|36.05|45.39||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Adjusted analysis utilizes a generalized linear mixed model which includes Baseline TSQM overall satisfaction scale score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline monthly migraine days (MMD), and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.||45.39|36.05|< 0.001
70955804|NCT00657020|141415066|SUPERIORITY_OR_OTHER|||||||0.2065||95.0|||||ANOVA|||Region of interest is left premotor cortex||||0.2065
71147700|NCT04825678|141789122|OTHER||LSM|30.84|STANDARD_ERROR_OF_MEAN|14.53||0.058|TWO_SIDED|95.0|-1.3|62.98||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Adjusted analysis utilizes a generalized linear mixed model which includes Baseline TSQM overall satisfaction scale score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.||62.98|-1.30|0.058
71147701|NCT04825678|141789123|OTHER||LSM|37.87|STANDARD_ERROR_OF_MEAN|4.62|<|0.001|TWO_SIDED|95.0|28.62|47.12||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Adjusted analysis utilizes a generalized linear mixed model which includes Baseline TSQM overall satisfaction scale score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.||47.12|28.62|< 0.001
70955805|NCT00657020|141415066|SUPERIORITY_OR_OTHER|||||||0.1837||95.0|||||ANOVA|||Region of interest is left substantia nigra/ventral tegmental area||||0.1837
70955806|NCT00657020|141415066|SUPERIORITY_OR_OTHER|||||||0.8195||95.0|||||ANOVA|||Region of interest is left substantia nigra/ventral tegmental area||||0.8195
70955807|NCT00657020|141415066|SUPERIORITY_OR_OTHER|||||||0.642||95.0|||||ANOVA|||Region of interest is left thalamus||||0.6420
70955808|NCT00657020|141415066|SUPERIORITY_OR_OTHER|||||||0.7475||95.0|||||ANOVA|||Region of interest is left thalamus||||0.7475
70955809|NCT00657020|141415066|SUPERIORITY_OR_OTHER|||||||0.9049||95.0|||||ANOVA|||Region of interest is left visual cortex||||0.9049
70955810|NCT00657020|141415066|SUPERIORITY_OR_OTHER|||||||0.183||95.0|||||ANOVA|||Region of interest is left visual cortex||||0.1830
70955811|NCT00657020|141415066|SUPERIORITY_OR_OTHER|||||||0.5318||95.0|||||ANOVA|||Region of interest is right anterior insula||||0.5318
70955812|NCT00657020|141415066|SUPERIORITY_OR_OTHER|||||||0.9588||95.0|||||ANOVA|||Region of interest is right anterior insula||||0.9588
71147702|NCT04825678|141789123|OTHER||LSM|43.25|STANDARD_ERROR_OF_MEAN|2.63|<|0.001|TWO_SIDED|95.0|38.06|48.44||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Adjusted analysis utilizes a generalized linear mixed model which includes Baseline TSQM overall satisfaction scale score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.||48.44|38.06|< 0.001
71147703|NCT04825678|141789132|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-44.9|STANDARD_ERROR_OF_MEAN|2.28|<|0.001|TWO_SIDED|95.0|-49.39|-40.41||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Continued SoC: Physical Function Domain||-40.41|-49.39|< 0.001
70955813|NCT00657020|141415066|SUPERIORITY_OR_OTHER|||||||0.7551||95.0|||||ANOVA|||Region of interest is right dorsal anterior cingulate cortex||||0.7551
70955814|NCT00657020|141415066|SUPERIORITY_OR_OTHER|||||||0.7895||95.0|||||ANOVA|||Region of interest is right dorsal anterior cingulate cortex||||0.7895
70955815|NCT00657020|141415066|SUPERIORITY_OR_OTHER|||||||0.9494||95.0|||||ANOVA|||Region of interest is right dorsolateral pre-frontal cortex||||0.9494
70955816|NCT00657020|141415066|SUPERIORITY_OR_OTHER|||||||0.4482||95.0|||||ANOVA|||Region of interest is right dorsolateral pre-frontal cortex||||0.4482
70955817|NCT00657020|141415066|SUPERIORITY_OR_OTHER|||||||0.9343||95.0|||||ANOVA|||Region of interest is right parietal cortex||||0.9343
70955818|NCT00657020|141415066|SUPERIORITY_OR_OTHER|||||||0.7711||95.0|||||ANOVA|||Region of interest is right parietal cortex||||0.7711
70955819|NCT00657020|141415066|SUPERIORITY_OR_OTHER|||||||0.4755||95.0|||||ANOVA|||Region of interest is right premotor cortex||||0.4755
71147704|NCT04825678|141789132|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-54.15|STANDARD_ERROR_OF_MEAN|8.43|<|0.001|TWO_SIDED|95.0|-73.43|-34.86||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Discontinued SoC: Physical Function Domain||-34.86|-73.43|< 0.001
71147705|NCT04825678|141789132|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed baseline MMD, and selected baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-44.35|STANDARD_ERROR_OF_MEAN|1.99|<|0.001|TWO_SIDED|95.0|-48.26|-40.44||P-value is nominal to compare the mean change from baseline at Week 24 to zero.|Mixed Models Analysis|||Continued SoC: Usual Activities Domain||-40.44|-48.26|< 0.001
71147706|NCT04825678|141789132|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-43.8|STANDARD_ERROR_OF_MEAN|4.47|<|0.001|TWO_SIDED|95.0|-53.51|-34.08||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Discontinued SoC: Usual Activities Domain||-34.08|-53.51|< 0.001
71147707|NCT04825678|141789132|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-44.39|STANDARD_ERROR_OF_MEAN|2.16|<|0.001|TWO_SIDED|95.0|-48.65|-40.14||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Continued SoC: Social Function Domain||-40.14|-48.65|< 0.001
71147708|NCT04825678|141789132|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-45.03|STANDARD_ERROR_OF_MEAN|6.97|<|0.001|TWO_SIDED|95.0|-60.28|-29.79||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Discontinued SoC: Social Function Domain||-29.79|-60.28|< 0.001
71147709|NCT04825678|141789132|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-45.5|STANDARD_ERROR_OF_MEAN|2.44|<|0.001|TWO_SIDED|95.0|-50.29|-40.7||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Continued SoC: Emotional Function Domain||-40.70|-50.29|< 0.001
71147710|NCT04825678|141789132|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-60.06|STANDARD_ERROR_OF_MEAN|10.98|<|0.001|TWO_SIDED|95.0|-85.16|-34.96||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Discontinued SoC: Emotional Function Domain||-34.96|-85.16|< 0.001
71147711|NCT04825678|141789133|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-34.38|STANDARD_ERROR_OF_MEAN|3.69|<|0.001|TWO_SIDED|95.0|-41.72|-27.03||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||EM: Physical Function Domain||-27.03|-41.72|< 0.001
71147712|NCT04825678|141789133|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-49.56|STANDARD_ERROR_OF_MEAN|2.48|<|0.001|TWO_SIDED|95.0|-54.44|-44.69||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||CM: Physical Function Domain||-44.69|-54.44|< 0.001
70955820|NCT00657020|141415066|SUPERIORITY_OR_OTHER|||||||0.3982||95.0|||||ANOVA|||Region of interest is right premotor cortex||||0.3982
70955821|NCT00657020|141415066|SUPERIORITY_OR_OTHER|||||||0.4622||95.0|||||ANOVA|||Region of interest is right thalamus||||0.4622
70955822|NCT00657020|141415066|SUPERIORITY_OR_OTHER|||||||0.4604||95.0|||||ANOVA|||Region of interest is right thalamus||||0.4604
70955823|NCT00657020|141415066|SUPERIORITY_OR_OTHER|||||||0.2485||95.0|||||ANOVA|||Region of interest is right visual cortex||||0.2485
70955824|NCT00657020|141415066|SUPERIORITY_OR_OTHER|||||||0.1931||95.0|||||ANOVA|||Region of interest is right visual cortex||||0.1931
70955825|NCT00657020|141415067|SUPERIORITY_OR_OTHER|||||||0.4535||95.0|||||ANOVA|||Null hypothesis considered the response time of treatments in comparison to be equal.||||0.4535
70955826|NCT00657020|141415067|SUPERIORITY_OR_OTHER|||||||0.1811||95.0|||||ANOVA|||Null hypothesis considered the response time of treatments in comparison to be equal.||||0.1811
70955827|NCT00657020|141415068|SUPERIORITY_OR_OTHER|||||||0.6261||95.0|||||ANOVA|||Null hypothesis considered treatments in comparison to be equal.||||0.6261
70955828|NCT00657020|141415068|SUPERIORITY_OR_OTHER|||||||0.0106||95.0|||||ANOVA|||Null hypothesis considered treatments in comparison to be equal.||||0.0106
70955829|NCT00657020|141415069|SUPERIORITY_OR_OTHER|||||||0.5544||95.0|||||ANOVA|||Region of interest is left parietal cortex.||||0.5544
70955830|NCT00657020|141415069|SUPERIORITY_OR_OTHER|||||||0.6716||95.0|||||ANOVA|||Region of interest is left parietal cortex.||||0.6716
70955831|NCT00657020|141415069|SUPERIORITY_OR_OTHER|||||||0.7511||95.0|||||ANOVA|||Region of interest is left superior occipital cortex.||||0.7511
70955832|NCT00657020|141415069|SUPERIORITY_OR_OTHER|||||||0.7959||95.0|||||ANOVA|||Region of interest is left superior occipital cortex.||||0.7959
70955833|NCT00657020|141415069|SUPERIORITY_OR_OTHER|||||||0.6418||95.0|||||ANOVA|||Region of interest is left visual cortex.||||0.6418
70955834|NCT00657020|141415069|SUPERIORITY_OR_OTHER|||||||0.2205||95.0|||||ANOVA|||Region of interest is left visual cortex.||||0.2205
70955835|NCT00657020|141415069|SUPERIORITY_OR_OTHER|||||||0.5135||95.0|||||ANOVA|||Region of interest is right parietal cortex.||||0.5135
70955836|NCT00657020|141415069|SUPERIORITY_OR_OTHER|||||||0.9781||95.0|||||ANOVA|||Region of interest is right parietal cortex.||||0.9781
70955837|NCT00657020|141415069|SUPERIORITY_OR_OTHER|||||||0.3755||95.0|||||ANOVA|||Region of interest is right premotor cortex.||||0.3755
70955838|NCT00657020|141415069|SUPERIORITY_OR_OTHER|||||||0.2612||95.0|||||ANOVA|||Region of interest is right premotor cortex.||||0.2612
70955839|NCT00657020|141415069|SUPERIORITY_OR_OTHER|||||||0.8486||95.0|||||ANOVA|||Region of interest is right superior occipital cortex.||||0.8486
70955840|NCT00657020|141415069|SUPERIORITY_OR_OTHER|||||||0.8318||95.0|||||ANOVA|||Region of interest is right superior occipital cortex.||||0.8318
70955841|NCT00657020|141415069|SUPERIORITY_OR_OTHER|||||||0.7554||95.0|||||ANOVA|||Region of interest is right visual cortex.||||0.7554
70955842|NCT00657020|141415069|SUPERIORITY_OR_OTHER|||||||0.5421||95.0|||||ANOVA|||Region of interest is right visual cortex.||||0.5421
70955843|NCT00657020|141415070|SUPERIORITY_OR_OTHER|||||||0.1963||95.0|||||ANOVA|||Null hypothesis considered response time of treatments in comparison to be equal.||||0.1963
70955844|NCT00657020|141415070|SUPERIORITY_OR_OTHER|||||||0.0959||95.0|||||ANOVA|||Null hypothesis considered response time of treatments in comparison to be equal.||||0.0959
70955845|NCT00657020|141415071|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||ANOVA|||Null hypothesis considered treatments in comparison to be equal.||||0.5400
70955846|NCT00657020|141415071|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||Null hypothesis considered the treatments in comparison to be equal.||||0.1800
70875030|NCT03510884|141234382|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Adjusted mean difference|-5.6|STANDARD_ERROR_OF_MEAN|7.1|=|0.4288|TWO_SIDED|97.5|-21.7|10.4||Threshold for significance at 0.025 level.|Robust regression model||Alirocumab Q2W versus Placebo Q2W|Multiple imputation approach followed by robust regression model. The robust regression model included the fixed categorical effect of treatment group and randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS and the continuous fixed covariate of Baseline lipoprotein (a) value.||10.4|-21.7|=0.4288
70875031|NCT03510884|141234382|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Adjusted mean difference|-13.5|STANDARD_ERROR_OF_MEAN|8.6|=|0.1148|TWO_SIDED|97.5|-32.7|5.7||Threshold for significance at 0.025 level.|Robust regression model||Alirocumab Q4W versus Placebo Q4W|Multiple imputation approach followed by robust regression model. The robust regression model included the fixed categorical effect of treatment group and randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS and the continuous fixed covariate of Baseline lipoprotein (a) value.||5.7|-32.7|=0.1148
70875032|NCT00856284|141234412|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 25 mg and glipizide in HbA1c change from Baseline was less than 0.3%. If the null hypothesis H01 was rejected, then H02 was tested to show noninferiority of alogliptin 12.5 mg versus glipizide with a margin of 0.3%. Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 12.5 mg and glipizide in HbA1c change from Baseline was less than 0.3%.|LS Mean Difference|-0.03|||||ONE_SIDED|98.75||0.059||||||The null hypotheses were tested in a fixed order at the 1-sided 0.0125 significance level at Weeks 52 and 104, independently: H01: Alogliptin 25 mg was inferior in HbA1c change from Baseline vs glipizide. H02: Alogliptin 12.5 mg was inferior vs glipizide. H03: Alogliptin 25 mg was not superior vs glipizide. H04: Alogliptin 12.5 mg was not superior vs glipizide. Each subsequent null hypothesis was tested only if all previously tested null hypotheses were rejected with respect to Weeks 52 and 104.||0.059||
70875033|NCT00856284|141234412|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 25 mg and glipizide in HbA1c change from Baseline was less than 0.3%. If the null hypothesis H01 was rejected, then H02 was tested to show noninferiority of alogliptin 12.5 mg versus glipizide with a margin of 0.3%. Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 12.5 mg and glipizide in HbA1c change from Baseline was less than 0.3%.|LS Mean Difference|-0.09|||||ONE_SIDED|98.75||0.003||||||||0.003||
70875034|NCT00856284|141234418|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 25 mg and glipizide in HbA1c change from Baseline was less than 0.3%. If the null hypothesis H01 was rejected, then H02 was tested to show noninferiority of alogliptin 12.5 mg versus glipizide with a margin of 0.3%. Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 12.5 mg and glipizide in HbA1c change from Baseline was less than 0.3%.|LS Mean Difference|-0.13|||||ONE_SIDED|98.75||-0.006||||||The null hypotheses were tested in a fixed order at the 1-sided 0.0125 significance level at Weeks 52 and 104, independently: H01: Alogliptin 25 mg was inferior in HbA1c change from Baseline vs glipizide. H02: Alogliptin 12.5 mg was inferior vs glipizide. H03: Alogliptin 25 mg was not superior vs glipizide. H04: Alogliptin 12.5 mg was not superior vs glipizide. Each subsequent null hypothesis was tested only if all previously tested null hypotheses were rejected with respect to Weeks 52 and 104.||-0.006||
70875035|NCT00856284|141234418|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 25 mg and glipizide in HbA1c change from Baseline was less than 0.3%. If the null hypothesis H01 was rejected, then H02 was tested to show noninferiority of alogliptin 12.5 mg versus glipizide with a margin of 0.3%. Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 12.5 mg and glipizide in HbA1c change from Baseline was less than 0.3%.|LS Mean Difference|-0.09|||||ONE_SIDED|98.75||0.035||||||||0.035||
70875036|NCT02560584|141234419|SUPERIORITY||||||<|0.0001|||||||Exact one-sided test for a single propor|||"The proportion of patients with malignancy detected only with BLC with Cysview was to be analyzed using an exact one-sided test for a single proportion based on the cumulative binomial distribution with a significance level of 2.5%.~Null hypothesis: Malignancy is detected with BL only in 0.5% or less of the patients"||||<0.0001
70875037|NCT02560584|141234421|SUPERIORITY||||||<|0.0001|||||||Exact one-sided test for single proporti|||"The proportion of patients with one or more CIS lesions detected with BL and none with WL was to be evaluated using an exact binomial test for single proportion with a significance level of 2.5% (one-sided).~Null hypothesis: One or more CIS lesions are detected with BLC with Cysview and none with WL in less than or equal to 0.1% of the patients."||||<0.0001
70875038|NCT02557698|141234429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.002|TWO_SIDED|95.0|-3.1|-0.8|||t-test, 2 sided|||H0=Intervention and control groups do not differ with respect to the TEWL forearm at visit 3 H1=The TEWL on the forearm at visit 3 differs between the groups||-0.8|-3.1|0.002
70875039|NCT02557698|141234430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3|||<|0.001|TWO_SIDED|95.0|-3.5|-1.2|||t-test, 2 sided|||||-1.2|-3.5|<0.001
70875040|NCT02557698|141234431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.024|TWO_SIDED|95.0|-3.2|-0.2|||t-test, 2 sided|||||-0.2|-3.2|0.024
70875041|NCT02557698|141234432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.017|TWO_SIDED|95.0|-3.1|-0.3|||t-test, 2 sided|||||-0.3|-3.1|0.017
70875042|NCT02557698|141234433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.964|TWO_SIDED|95.0|-3.9|3.7|||t-test, 2 sided|||||3.7|-3.9|0.964
70875043|NCT02557698|141234434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4||||0.025|TWO_SIDED|95.0|0.5|8.2|||t-test, 2 sided|||||8.2|0.5|0.025
70875044|NCT02557698|141234435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.458|TWO_SIDED|95.0|-2.5|1.1|||t-test, 2 sided|||||1.1|-2.5|0.458
70875045|NCT02557698|141234436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.066|TWO_SIDED|95.0|-3.5|0.1|||t-test, 2 sided|||||0.1|-3.5|0.066
70875046|NCT02557698|141234437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6||||0.171|TWO_SIDED|95.0|-13.7|2.5|||t-test, 2 sided|||||2.5|-13.7|0.171
70875047|NCT02557698|141234438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5||||0.059|TWO_SIDED|95.0|-15.3|0.3|||t-test, 2 sided|||||0.3|-15.3|0.059
70875048|NCT02557698|141234439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.4|TWO_SIDED|95.0|-0.2|0.5|||t-test, 2 sided|||||0.5|-0.2|0.400
70875049|NCT02557698|141234440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.1|TWO_SIDED|95.0|-0.1|0.4|||t-test, 2 sided|||||0.4|-0.1|0.100
70875050|NCT02557698|141234441|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
70875051|NCT02557698|141234442|SUPERIORITY_OR_OTHER|||||||0.914|||||||Wilcoxon (Mann-Whitney)|||||||0.914
70875052|NCT02557698|141234443|SUPERIORITY_OR_OTHER|||||||0.822|||||||Wilcoxon (Mann-Whitney)|||||||0.822
70875053|NCT02557698|141234444|SUPERIORITY_OR_OTHER|||||||0.585|||||||Wilcoxon (Mann-Whitney)|||||||0.585
70875054|NCT02557698|141234445|SUPERIORITY_OR_OTHER|||||||0.259|||||||Wilcoxon (Mann-Whitney)|||||||0.259
70875055|NCT02557698|141234446|SUPERIORITY_OR_OTHER|||||||0.581|||||||Wilcoxon (Mann-Whitney)|||||||0.581
70875056|NCT02557698|141234447|SUPERIORITY_OR_OTHER|||||||0.182|||||||Wilcoxon (Mann-Whitney)|||||||0.182
70875057|NCT02557698|141234448|SUPERIORITY_OR_OTHER|||||||0.759|||||||Wilcoxon (Mann-Whitney)|||||||0.759
70875058|NCT02557698|141234449|SUPERIORITY_OR_OTHER|||||||0.831|||||||Wilcoxon (Mann-Whitney)|||||||0.831
70875059|NCT02557698|141234450|SUPERIORITY_OR_OTHER|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||||||0.084
70875060|NCT02557698|141234451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6||||0.07|TWO_SIDED|95.0|-0.3|7.4|||t-test, 2 sided|||||7.4|-0.3|0.07
70875061|NCT02557698|141234452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1||||0.029|TWO_SIDED|95.0|0.4|7.7|||t-test, 2 sided|||||7.7|0.4|0.029
70875062|NCT02557698|141234453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.325|TWO_SIDED|95.0|-1.8|0.6|||t-test, 2 sided|||||0.6|-1.8|0.325
70875063|NCT02557698|141234454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.365|TWO_SIDED|95.0|-2.6|0.9|||t-test, 2 sided|||||0.9|-2.6|0.365
70875064|NCT02557698|141234455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.143|TWO_SIDED|95.0|-8.5|1.3|||t-test, 2 sided|||||1.3|-8.5|0.143
70875065|NCT02557698|141234456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.662|TWO_SIDED|95.0|-6.5|4.2|||t-test, 2 sided|||||4.2|-6.5|0.662
70875066|NCT02557698|141234457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.326|TWO_SIDED|95.0|-0.4|0.1|||t-test, 2 sided|||||0.1|-0.4|0.326
70875067|NCT02557698|141234458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.687|TWO_SIDED|95.0|-0.2|0.4|||t-test, 2 sided|||||0.4|-0.2|0.687
70875068|NCT00267046|141234459|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fine and Gray method.|||||||<0.001
70875069|NCT01077856|141234485|SUPERIORITY_OR_OTHER_LEGACY||Standardized Prevalence Ratio (SPR)|1.34|||||TWO_SIDED|95.0|0.89|2.0|||||SPR is the age-adjusted ratio of percentage of live births with a major congenital anomaly (Women who received Gardasil / Women in the general population)|||2.00|0.89|
70875070|NCT01077856|141234485|SUPERIORITY_OR_OTHER_LEGACY||Standardized Prevalence Ratio (SPR)|1.59|||||TWO_SIDED|95.0|0.0|4.77|||||SPR is the age-adjusted ratio of percentage of live births with a major congenital anomaly (Women who received Gardasil / Women in the general population)|||4.77|0.00|
70875071|NCT01077856|141234485|SUPERIORITY_OR_OTHER_LEGACY||Standardized Prevalence Ratio (SPR)|0.86|||||TWO_SIDED|95.0|0.0|2.02|||||SPR is the age-adjusted ratio of percentage of live births with a major congenital anomaly (Women who received Gardasil / Women in the general population)|||2.02|0.00|
70875072|NCT03950167|141234490|OTHER||Mean Difference (Final Values)|0.85||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Fasting CCK level difference: hyperemesis group-control group|||||0.05
70875073|NCT03950167|141234490|OTHER||Mean Difference (Net)|0.68||||0.05|TWO_SIDED||||||t-test, 2 sided||p value demonstrated above is the calculated value. Postprandial CCK level difference: hyperemesis group-control group|Since this is the first study comparing both CCK levels and GB functions in patients diagnosed with hyperemesis gravidarum (HG) and healthy pregnant women, a power analysis was not feasible.||||0.05
70875074|NCT03950167|141234491|OTHER||Mean Difference (Final Values)|0.91||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Fasting GB wall thickness: Hyperemesis group-control group|||||0.05
70875075|NCT03950167|141234491|OTHER||Mean Difference (Final Values)|0.23||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Postprandial GB wall thickness: hyperemesis group-control group|||||0.05
70875076|NCT03950167|141234492|OTHER||Mean Difference (Final Values)|0.41||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Fasting GB volume: hyperemesis group-control group|||||0.05
70875077|NCT03950167|141234492|OTHER||Mean Difference (Final Values)|0.71||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Postprandial GB volume: hyperemesis group-control group|||||0.05
70875078|NCT03950167|141234493|OTHER||Mean Difference (Final Values)|0.22||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Fasting GB ejection fraction: hyperemesis group-control group|||||0.05
70875079|NCT03950167|141234493|OTHER||Mean Difference (Final Values)|0.63||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Postprandial GB ejection fraction: hyperemesis group-control group|||||0.05
70875080|NCT01124422|141234495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.6|STANDARD_ERROR_OF_MEAN|20.58||0.181|TWO_SIDED|95.0|-68.2|13.0||ANCOVA model with terms for treatment, investigator, Oxycon stratum, and baseline value|ANCOVA|||||13.0|-68.2|0.181
70875081|NCT00137046|141234532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|0.01||||90.0|-0.041|-0.007|||ANCOVA|||Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.007|-0.041|
70875082|NCT00137046|141234532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.022|STANDARD_ERROR_OF_MEAN|0.011||||90.0|-0.04|-0.003|||ANCOVA|||Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.003|-0.040|
70875083|NCT00137046|141234532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.012||||90.0|-0.038|0.001|||ANCOVA|||Month 9; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.001|-0.038|
70875084|NCT00137046|141234532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.038|STANDARD_ERROR_OF_MEAN|0.012||||90.0|-0.058|-0.019|||ANCOVA|||Month 12; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.019|-0.058|
70875085|NCT00137046|141234532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.065|-0.02|||ANCOVA|||Month 15; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.020|-0.065|
70875086|NCT00137046|141234532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.043|0.002|||ANCOVA|||Month 18; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.002|-0.043|
70875087|NCT00137046|141234532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.043|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.066|-0.02|||ANCOVA|||Month 21; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.020|-0.066|
70875088|NCT00137046|141234532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.033|STANDARD_ERROR_OF_MEAN|0.015||||90.0|-0.058|-0.009|||ANCOVA|||Month 24; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.009|-0.058|
70875089|NCT00137046|141234532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.015||||90.0|-0.039|0.009|||ANCOVA|||Follow-up Month 1; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.009|-0.039|
70875090|NCT00137046|141234532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.027|0.017|||ANCOVA|||Follow-up Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.017|-0.027|
70875091|NCT00137046|141234532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.013|STANDARD_ERROR_OF_MEAN|0.015||||90.0|-0.037|0.012|||ANCOVA|||Follow-up Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.012|-0.037|
70875092|NCT00137046|141234532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.019||||90.0|-0.076|-0.014|||ANCOVA|||Extension Month 1; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.014|-0.076|
70875093|NCT00137046|141234532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.019||||90.0|-0.076|-0.013|||ANCOVA|||Extension Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.013|-0.076|
70875094|NCT00137046|141234532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.019||||90.0|-0.071|-0.008|||ANCOVA|||Extension Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.008|-0.071|
70875095|NCT00137046|141234532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.041|STANDARD_ERROR_OF_MEAN|0.02||||90.0|-0.074|-0.008|||ANCOVA|||Extension Month 9; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.008|-0.074|
70875096|NCT00137046|141234532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.056|STANDARD_ERROR_OF_MEAN|0.019||||90.0|-0.088|-0.025|||ANCOVA|||Extension Month 12; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.025|-0.088|
70875097|NCT00137046|141234532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|0.019||||90.0|-0.071|-0.007|||ANCOVA|||Extension Month 15; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.007|-0.071|
71147713|NCT04825678|141789133|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed baseline MMD, and selected baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-35.76|STANDARD_ERROR_OF_MEAN|2.88|<|0.001|TWO_SIDED|95.0|-41.47|-30.06||P-value is nominal to compare the mean change from baseline at Week 24 to zero.|Mixed Models Analysis|||EM: Usual Activities Domain||-30.06|-41.47|< 0.001
71147714|NCT04825678|141789133|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-46.7|STANDARD_ERROR_OF_MEAN|2.23|<|0.001|TWO_SIDED|95.0|-51.1|-42.29||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||CM: Usual Activities Domain||-42.29|-51.10|< 0.001
71147715|NCT04825678|141789133|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-36.42|STANDARD_ERROR_OF_MEAN|3.26|<|0.001|TWO_SIDED|95.0|-42.89|-29.96||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||EM: Social Function Domain||-29.96|-42.89|< 0.001
70875098|NCT00137046|141234532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044|STANDARD_ERROR_OF_MEAN|0.021||||90.0|-0.079|-0.01|||ANCOVA|||Extension Month 18; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.010|-0.079|
70875099|NCT00137046|141234532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.022||||90.0|-0.055|0.016|||ANCOVA|||Extension Month 21; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.016|-0.055|
70875100|NCT00137046|141234532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.022||||90.0|-0.079|-0.004|||ANCOVA|||Extension Month 24; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.004|-0.079|
70875101|NCT00137046|141234532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.055|STANDARD_ERROR_OF_MEAN|0.022||||90.0|-0.091|-0.019|||ANCOVA|||Extension Month 27; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.019|-0.091|
70875102|NCT00137046|141234532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.022||||90.0|-0.081|-0.01|||ANCOVA|||Extension Month 30; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.010|-0.081|
70875103|NCT00137046|141234532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.036|STANDARD_ERROR_OF_MEAN|0.023||||90.0|-0.073|0.002|||ANCOVA|||Extension Month 33; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.002|-0.073|
70875104|NCT00137046|141234532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.079|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.121|-0.038|||ANCOVA|||Extension Month 36; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.038|-0.121|
70875105|NCT00137046|141234532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.038||||90.0|-0.124|0.003|||ANCOVA|||Extension Month 39; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.003|-0.124|
70875106|NCT00137046|141234532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.066|STANDARD_ERROR_OF_MEAN|0.02||||90.0|-0.098|-0.033|||ANCOVA|||Extension Month 39 (LOCF); Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.033|-0.098|
70875107|NCT00137046|141234532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.085|-0.004|||ANCOVA|||Extension Follow Up Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.004|-0.085|
70875108|NCT00137046|141234534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.055||||90.0|-0.06|0.122|||ANCOVA|||Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.122|-0.060|
70875109|NCT00137046|141234534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.062||||90.0|0.033|0.239|||ANCOVA|||Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.239|0.033|
71147716|NCT04825678|141789133|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-46.73|STANDARD_ERROR_OF_MEAN|2.41|<|0.001|TWO_SIDED|95.0|-51.49|-41.98||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||CM: Social Function Domain||-41.98|-51.49|< 0.001
70875110|NCT00137046|141234534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.068||||90.0|0.0|0.224|||ANCOVA|||Month 9; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.224|-0.000|
70875111|NCT00137046|141234534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.257|STANDARD_ERROR_OF_MEAN|0.071||||90.0|0.141|0.374|||ANCOVA|||Month 12; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.374|0.141|
70875112|NCT00137046|141234534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.071||||90.0|0.04|0.273|||ANCOVA|||Month 15; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.273|0.040|
70875113|NCT00137046|141234534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.072||||90.0|0.065|0.3|||ANCOVA|||Month 18; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.300|0.065|
70875114|NCT00137046|141234534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.078||||90.0|0.06|0.319|||ANCOVA|||Month 21; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.319|0.060|
70875115|NCT00137046|141234534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.316|STANDARD_ERROR_OF_MEAN|0.077||||90.0|0.19|0.443|||ANCOVA|||Month 24; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.443|0.190|
70875116|NCT00137046|141234534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.079||||90.0|-0.037|0.224|||ANCOVA|||Follow-up Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.224|-0.037|
70875117|NCT00137046|141234534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.075||||90.0|-0.103|0.145|||ANCOVA|||Follow-up Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.145|-0.103|
70875118|NCT00137046|141234534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.082||||90.0|-0.023|0.248|||ANCOVA|||Extension Month 1; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.248|-0.023|
70875119|NCT00137046|141234534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.273|STANDARD_ERROR_OF_MEAN|0.089||||90.0|0.126|0.419|||ANCOVA|||Extension Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.419|0.126|
70875120|NCT00137046|141234534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.363|STANDARD_ERROR_OF_MEAN|0.087||||90.0|0.219|0.507|||ANCOVA|||Extension Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.507|0.219|
70875121|NCT00137046|141234534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|STANDARD_ERROR_OF_MEAN|0.091||||90.0|0.128|0.428|||ANCOVA|||Extension Month 9; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.428|0.128|
70875122|NCT00137046|141234534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.293|STANDARD_ERROR_OF_MEAN|0.091||||90.0|0.144|0.442|||ANCOVA|||Extension Month 12; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.442|0.144|
70875123|NCT00137046|141234534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.094||||90.0|0.058|0.369|||ANCOVA|||Extension Month 15; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.369|0.058|
70875124|NCT00137046|141234534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.243|STANDARD_ERROR_OF_MEAN|0.086||||90.0|0.101|0.386|||ANCOVA|||Extension Month 18; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.386|0.101|
70875125|NCT00137046|141234534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.227|STANDARD_ERROR_OF_MEAN|0.09||||90.0|0.079|0.376|||ANCOVA|||Extension Month 21; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.376|0.079|
70875126|NCT00137046|141234534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.225|STANDARD_ERROR_OF_MEAN|0.089||||90.0|0.079|0.372|||ANCOVA|||Extension Month 24; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.372|0.079|
70875127|NCT00137046|141234534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.211|STANDARD_ERROR_OF_MEAN|0.095||||90.0|0.055|0.368|||ANCOVA|||Extension Month 27; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.368|0.055|
70875128|NCT00137046|141234534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.331|STANDARD_ERROR_OF_MEAN|0.092||||90.0|0.18|0.483|||ANCOVA|||Extension Month 30; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.483|0.180|
70875129|NCT00137046|141234534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.462|STANDARD_ERROR_OF_MEAN|0.097||||90.0|0.302|0.622|||ANCOVA|||Extension Month 33; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.622|0.302|
70875130|NCT00137046|141234534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.115||||90.0|0.221|0.6|||ANCOVA|||Extension Month 36; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.600|0.221|
70875131|NCT00137046|141234534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.451|STANDARD_ERROR_OF_MEAN|0.161||||90.0|0.183|0.718|||ANCOVA|||Extension Month 39; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.718|0.183|
70875132|NCT00137046|141234534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032|STANDARD_ERROR_OF_MEAN|0.124||||90.0|-0.174|0.237|||ANCOVA|||Extension Follow Up Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.237|-0.174|
70875133|NCT00137046|141234537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.81|STANDARD_ERROR_OF_MEAN|6.33||||90.0|-25.24|-4.39|||ANCOVA|||Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-4.39|-25.24|
70875134|NCT00137046|141234537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.83|STANDARD_ERROR_OF_MEAN|6.27||||90.0|-35.16|-14.51|||ANCOVA|||Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-14.51|-35.16|
70875135|NCT00137046|141234537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.16|STANDARD_ERROR_OF_MEAN|6.92||||90.0|-37.56|-14.75|||ANCOVA|||Month 9; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-14.75|-37.56|
70875136|NCT00137046|141234537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.46|STANDARD_ERROR_OF_MEAN|6.74||||90.0|-30.56|-8.36|||ANCOVA|||Month 12; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-8.36|-30.56|
70875137|NCT00137046|141234537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.97|STANDARD_ERROR_OF_MEAN|6.65||||90.0|-50.93|-29.0|||ANCOVA|||Month 15; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-29.00|-50.93|
70875138|NCT00137046|141234537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.08|STANDARD_ERROR_OF_MEAN|7.02||||90.0|-27.65|-4.51|||ANCOVA|||Month 18; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-4.51|-27.65|
70875139|NCT00137046|141234537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.54|STANDARD_ERROR_OF_MEAN|6.76||||90.0|-24.69|-2.39|||ANCOVA|||Month 21; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-2.39|-24.69|
70875140|NCT00137046|141234537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.86|STANDARD_ERROR_OF_MEAN|7.29||||90.0|-30.88|-6.84|||ANCOVA|||Month 24; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-6.84|-30.88|
70875141|NCT00137046|141234537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.56|STANDARD_ERROR_OF_MEAN|8.12||||90.0|-9.83|16.96|||ANCOVA|||Follow-up Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin.Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||16.96|-9.83|
70875142|NCT00137046|141234537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.8|STANDARD_ERROR_OF_MEAN|8.2||||90.0|-31.32|-4.27|||ANCOVA|||Extension Month 1; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-4.27|-31.32|
70875143|NCT00137046|141234537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.71|STANDARD_ERROR_OF_MEAN|7.72||||90.0|-33.44|-7.99|||ANCOVA|||Extension Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-7.99|-33.44|
70875144|NCT00137046|141234537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|7.8||||90.0|-11.06|14.66|||ANCOVA|||Extension Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||14.66|-11.06|
70875145|NCT00137046|141234537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.72|STANDARD_ERROR_OF_MEAN|9.02||||90.0|-23.61|6.17|||ANCOVA|||Extension Month 9; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||6.17|-23.61|
70875146|NCT00137046|141234537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.34|STANDARD_ERROR_OF_MEAN|7.84||||90.0|-29.28|-3.4|||ANCOVA|||Extension Month 12; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-3.40|-29.28|
70875147|NCT00137046|141234537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.99|STANDARD_ERROR_OF_MEAN|8.25||||90.0|-26.6|0.63|||ANCOVA|||Extension Month 15; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||0.63|-26.60|
70875148|NCT00137046|141234537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.22|STANDARD_ERROR_OF_MEAN|8.58||||90.0|-24.39|3.94|||ANCOVA|||Extension Month 18; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||3.94|-24.39|
70875149|NCT00137046|141234537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.64|STANDARD_ERROR_OF_MEAN|8.82||||90.0|-43.19|-14.09|||ANCOVA|||Extension Month 21; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-14.09|-43.19|
70875150|NCT00137046|141234537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.99|STANDARD_ERROR_OF_MEAN|8.91||||90.0|-23.69|5.71|||ANCOVA|||Extension Month 24; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||5.71|-23.69|
70875151|NCT00137046|141234537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.52|STANDARD_ERROR_OF_MEAN|8.8||||90.0|-24.04|5.0|||ANCOVA|||Extension Month 27; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||5.00|-24.04|
70875152|NCT00137046|141234537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|8.67||||90.0|-24.71|3.92|||ANCOVA|||Extension Month 30; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||3.92|-24.71|
71147717|NCT04825678|141789133|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-41.44|STANDARD_ERROR_OF_MEAN|4.04|<|0.001|TWO_SIDED|95.0|-49.47|-33.4||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||EM: Emotional Function Domain||-33.40|-49.47|< 0.001
71147718|NCT04825678|141789133|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-47.67|STANDARD_ERROR_OF_MEAN|2.68|<|0.001|TWO_SIDED|95.0|-52.95|-42.39||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||CM: Emotional Function Domain||-42.39|-52.95|< 0.001
70875153|NCT00137046|141234537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.17|STANDARD_ERROR_OF_MEAN|9.24||||90.0|-21.42|9.09|||ANCOVA|||Extension Month 33; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||9.09|-21.42|
70875154|NCT00137046|141234537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.39|STANDARD_ERROR_OF_MEAN|9.44||||90.0|-20.98|10.21|||ANCOVA|||Extension Month 36; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||10.21|-20.98|
71147719|NCT03818256|141789134|SUPERIORITY||Least Squares Mean Difference|0.11||||0.8511|TWO_SIDED|95.0|-1.03|1.24|||Mixed Models Analysis|||||1.24|-1.03|0.8511
71147720|NCT03818256|141789138|SUPERIORITY||Odds Ratio (OR)|0.82||||0.8169|TWO_SIDED|95.0|0.15|4.474|||Regression, Logistic|||||4.474|0.150|0.8169
71147721|NCT03818256|141789139|SUPERIORITY||Location shift|0.175||||0.9285|TWO_SIDED|95.0|-2.86|2.78|||Wilcoxon rank-sum test|||||2.780|-2.860|0.9285
71147722|NCT03818256|141789140|SUPERIORITY||Least squares mean difference|0.007||||0.5669|TWO_SIDED|95.0|-0.018|0.033|||Mixed Models Analysis|||||0.033|-0.018|0.5669
70875155|NCT00137046|141234537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.58|STANDARD_ERROR_OF_MEAN|13.77||||90.0|-38.43|7.26|||ANCOVA|||Extension Month 39; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||7.26|-38.43|
70875156|NCT00137046|141234537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.84|STANDARD_ERROR_OF_MEAN|11.27||||90.0|-15.79|21.46|||ANCOVA|||Extension Follow Up Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||21.46|-15.79|
70875157|NCT00137046|141234538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.523|STANDARD_ERROR_OF_MEAN|0.196||||90.0|-0.846|-0.199|||ANCOVA|||Month 3; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.199|-0.846|
71147723|NCT02086175|141789141|SUPERIORITY||percent|48.0||||0.044|TWO_SIDED|90.0|31.0|66.0|||Fisher Exact|||"Patients will be accrued in a single stage design, with a goal accrual of 25 patients.~Assuming a 30% response rate with rituximab alone, if the true but unknown rate of CR or PR is 50% with the addition of Imprime PGG, the probability of observing 11 or more patients with a response is 0.79 with 0.098 one-sided type-I error.~Therefore a study with 25 patients, in which an observed response rate of 11/25 (44%) would be considered worthy of further consideration."||66|31|0.044
71147724|NCT04586205|141789220|OTHER|||||||0.024|||||||ANOVA|||The baseline measurement for this analysis is the Sternberg Sorting Task (SST) at Baseline. This task is designed to assess how individuals store and retrieve random information from short-term memory. This task was administered to all participants before they were randomized into one of two groups (active TMS first then sham TMS or sham TMS first then active TMS).||||0.024
71147725|NCT04586205|141789221|OTHER||Mean Difference (Final Values)|0.02||||0.18|TWO_SIDED||||||t-test, 2 sided||The difference in means between High-Load IAPS (.69) and Low-Load IAPS (.67) in the group that received active then sham TMS.|The baseline measurement for this analysis is the International Affective Picture System (IAPS) at baseline. This is an emotional task using IAPS picture that will also compare low load and high load conditions. The number of images will vary by condition load, but for both the high-load \& low-load conditions, participants will look at IAPS pictures and answer questions about the images. We compare mean High-Load IAPS and Low-Load IAPS scores in the group that received active then sham TMS.||||0.18
71147726|NCT04586205|141789222|OTHER|||||||0.19|||||||Chi-squared|||The outcome measure for this analysis was the International Affective Picture System (IAPS).||||0.19
71147727|NCT04586205|141789223|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
71147728|NCT04684836|141789224|SUPERIORITY|The analysis leveraged a difference-in-differences research design in an intent-to-treat framework, comparing outcomes for patients receiving care at high-telehealth practices with patients at comparable low-telehealth practices, before relative to after the onset of the pandemic (when telehealth use increased significantly).|Mean Difference (Net)|-0.0255||||0.0793|TWO_SIDED||||||Regression, Linear|All models included practice and year-quarter fixed effects, and clustered standard errors at the practice level.|This is the Unadjusted model, which included only an indicator for high telemedicine practice, post-period, and its two-way interaction.|||||0.0793
71147729|NCT04684836|141789224|SUPERIORITY|Difference-in-differences model|Mean Difference (Net)|-0.0786||||0.5739|TWO_SIDED|||||This is the fully adjusted regression model, which controlled for patient age group, gender, dual status, race, average percent of 65+ patients, risk score category, rural vs urban, and zip-code level characteristics.|Regression, Linear|||||||0.5739
71147730|NCT04684836|141789225|SUPERIORITY||Mean Difference (Net)|-0.0014||||0.3261|TWO_SIDED|||||This is an adjusted model, which included only an indicator for high telemedicine practice, post-period, and its two-way interaction.|Regression, Linear|||Difference-in-differences model||||0.3261
71147731|NCT04684836|141789225|SUPERIORITY||Mean Difference (Net)|0.0806|||<|0.01|TWO_SIDED|||||This is a fully adjusted regression model, which controlled for patient age group, gender, dual status, race, average percent of 65+ patients, risk score category, rural vs urban, and zip-code level characteristics.|Regression, Linear|||Difference-in-differences model||||<0.01
70955847|NCT01144052|141415072|NON_INFERIORITY_OR_EQUIVALENCE|No statistical hypothesis tests for efficacy were performed as this was a pilot study serving to generate first data and hypotheses.||||||0.125||95.0|||||Log Rank|||||||0.125
70875158|NCT00137046|141234538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.113|STANDARD_ERROR_OF_MEAN|0.26||||90.0|-1.541|-0.685|||ANCOVA|||Month 6; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.685|-1.541|
70875159|NCT00137046|141234538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.359|STANDARD_ERROR_OF_MEAN|0.29||||90.0|-1.836|-0.882|||ANCOVA|||Month 9; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.882|-1.836|
70875160|NCT00137046|141234538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.184|STANDARD_ERROR_OF_MEAN|0.314||||90.0|-1.702|-0.666|||ANCOVA|||Month 12; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.666|-1.702|
70875161|NCT00137046|141234538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.426|STANDARD_ERROR_OF_MEAN|0.338||||90.0|-1.984|-0.869|||ANCOVA|||Month 15; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.869|-1.984|
70875162|NCT00137046|141234538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.717|STANDARD_ERROR_OF_MEAN|0.384||||90.0|-2.35|-1.084|||ANCOVA|||Month 18; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-1.084|-2.350|
70875163|NCT00137046|141234538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.273|STANDARD_ERROR_OF_MEAN|0.411||||90.0|-1.95|-0.596|||ANCOVA|||Month 21; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.596|-1.950|
70875164|NCT00137046|141234538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.069|STANDARD_ERROR_OF_MEAN|0.439||||90.0|-1.792|-0.346|||ANCOVA|||Month 24; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.346|-1.792|
70875165|NCT00137046|141234538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.785|STANDARD_ERROR_OF_MEAN|0.418||||90.0|-1.475|-0.096|||ANCOVA|||Follow-up Month 3; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.096|-1.475|
70875166|NCT00137046|141234538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.445|STANDARD_ERROR_OF_MEAN|0.406||||90.0|-1.114|0.224|||ANCOVA|||Follow-up Month 6; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||0.224|-1.114|
70875167|NCT00137046|141234538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.654||||90.0|-1.133|1.025|||ANCOVA|||Extension Month 1; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||1.025|-1.133|
70875168|NCT00137046|141234538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.336|STANDARD_ERROR_OF_MEAN|0.668||||90.0|-2.438|-0.235|||ANCOVA|||Extension Month 3; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.235|-2.438|
70875169|NCT00137046|141234538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.462|STANDARD_ERROR_OF_MEAN|0.542||||90.0|-2.356|-0.568|||ANCOVA|||Extension Month 6; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.568|-2.356|
70875170|NCT00137046|141234538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.385|STANDARD_ERROR_OF_MEAN|0.564||||90.0|-2.316|-0.454|||ANCOVA|||Extension Month 9; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.454|-2.316|
70875171|NCT00137046|141234538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.955|STANDARD_ERROR_OF_MEAN|0.559||||90.0|-1.877|-0.034|||ANCOVA|||Extension Month 12; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.034|-1.877|
70875172|NCT00137046|141234538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.588||||90.0|-1.97|-0.03|||ANCOVA|||Extension Month 15; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.030|-1.970|
70875173|NCT00137046|141234538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|0.655||||90.0|-2.041|0.121|||ANCOVA|||Extension Month 18; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||0.121|-2.041|
70875174|NCT00137046|141234538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.667|STANDARD_ERROR_OF_MEAN|0.668||||90.0|-2.77|-0.565|||ANCOVA|||Extension Month 21; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.565|-2.770|
71147732|NCT04684836|141789226|SUPERIORITY||Mean Difference (Net)|-0.0217||||0.1101|TWO_SIDED|||||This is an adjusted unadjusted model, which included only an indicator for high telemedicine practice, post-period, and its two-way interaction.|Regression, Linear|||Difference-in-differences||||0.1101
70875175|NCT00137046|141234538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.872|STANDARD_ERROR_OF_MEAN|0.692||||90.0|-3.013|-0.73|||ANCOVA|||Extension Month 24; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.730|-3.013|
70875176|NCT00137046|141234538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.887|STANDARD_ERROR_OF_MEAN|0.725||||90.0|-3.084|-0.69|||ANCOVA|||Extension Month 27; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.690|-3.084|
70875177|NCT00137046|141234538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.794|STANDARD_ERROR_OF_MEAN|0.891||||90.0|-4.264|-1.324|||ANCOVA|||Extension Month 30; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-1.324|-4.264|
70875178|NCT00137046|141234538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.287|STANDARD_ERROR_OF_MEAN|1.091||||90.0|-5.088|-1.485|||ANCOVA|||Extension Month 33; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-1.485|-5.088|
70875179|NCT00137046|141234538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.486|STANDARD_ERROR_OF_MEAN|0.857||||90.0|-2.901|-0.071|||ANCOVA|||Extension Month 36; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.071|-2.901|
70955848|NCT01144052|141415073|SUPERIORITY_OR_OTHER|||||||0.447||95.0|||||non-parametric|||||||0.447
70875180|NCT00137046|141234538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.131|STANDARD_ERROR_OF_MEAN|1.356||||90.0|-5.382|-0.88|||ANCOVA|||Extension Month 39; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.880|-5.382|
70875181|NCT00137046|141234538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.487|STANDARD_ERROR_OF_MEAN|0.866||||90.0|-2.918|-0.055|||ANCOVA|||Extension Follow Up Month 3; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.055|-2.918|
70875182|NCT00137046|141234547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.744|STANDARD_ERROR_OF_MEAN|0.144||||90.0|-0.981|-0.506|||ANCOVA|||Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.506|-0.981|
70875183|NCT00137046|141234547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.797|STANDARD_ERROR_OF_MEAN|0.167||||90.0|-1.073|-0.522|||ANCOVA|||Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.522|-1.073|
70875184|NCT00137046|141234547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.667|STANDARD_ERROR_OF_MEAN|0.171||||90.0|-0.949|-0.384|||ANCOVA|||Month 9; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.384|-0.949|
70875185|NCT00137046|141234547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.826|STANDARD_ERROR_OF_MEAN|0.181||||90.0|-1.123|-0.528|||ANCOVA|||Month 12; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.528|-1.123|
70875186|NCT00137046|141234547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.19||||90.0|-0.923|-0.296|||ANCOVA|||Month 15; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.296|-0.923|
70875187|NCT00137046|141234547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.577|STANDARD_ERROR_OF_MEAN|0.202||||90.0|-0.91|-0.245|||ANCOVA|||Month 18; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.245|-0.910|
70875188|NCT00137046|141234547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.613|STANDARD_ERROR_OF_MEAN|0.212||||90.0|-0.962|-0.263|||ANCOVA|||Month 21; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.263|-0.962|
70875189|NCT00137046|141234547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.385|STANDARD_ERROR_OF_MEAN|0.213||||90.0|-0.736|-0.034|||ANCOVA|||Month 24; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.034|-0.736|
71147733|NCT04684836|141789226|SUPERIORITY||Mean Difference (Net)|0.5551||||0.4618|TWO_SIDED|||||This is a fully adjusted regression model, which controlled for patient age group, gender, dual status, race, average percent of 65+ patients, risk score category, rural vs urban, and zip-code level characteristics.|Regression, Linear|||Difference-in-differences||||0.4618
70875190|NCT00137046|141234547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.211||||90.0|-0.197|0.497|||ANCOVA|||Follow-up Month 1; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.497|-0.197|
71147734|NCT04684836|141789228|SUPERIORITY||Mean Difference (Net)|-0.0012||||0.8577|TWO_SIDED|||||This is an unadjusted model, which included only an indicator for high telemedicine practice, post-period, and its two-way interaction|Regression, Linear|||Difference-in-differences||||0.8577
70875191|NCT00137046|141234547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.198||||90.0|-0.16|0.492|||ANCOVA|||Follow-up Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.492|-0.160|
70875192|NCT00137046|141234547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.208||||90.0|-0.274|0.411|||ANCOVA|||Follow-up Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.411|-0.274|
70875193|NCT00137046|141234547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.252||||90.0|-0.876|-0.043|||ANCOVA|||Extension Month 1; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.043|-0.876|
70875194|NCT00137046|141234547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.579|STANDARD_ERROR_OF_MEAN|0.247||||90.0|-0.986|-0.172|||ANCOVA|||Extension Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.172|-0.986|
70875195|NCT00137046|141234547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.255||||90.0|-0.88|-0.04|||ANCOVA|||Extension Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.040|-0.880|
70875196|NCT00137046|141234547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.385|STANDARD_ERROR_OF_MEAN|0.265||||90.0|-0.822|0.053|||ANCOVA|||Extension Month 9; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.053|-0.822|
70875197|NCT00137046|141234547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.268||||90.0|-1.372|-0.487|||ANCOVA|||Extension Month 12; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.487|-1.372|
70955849|NCT01144052|141415074|SUPERIORITY_OR_OTHER|||||||0.447|||||||non-parametric|||||||0.447
70955850|NCT01144052|141415075|SUPERIORITY_OR_OTHER|||||||0.206|||||||t-test, 2 sided|||||||0.206
70875198|NCT00137046|141234547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.823|STANDARD_ERROR_OF_MEAN|0.286||||90.0|-1.296|-0.351|||ANCOVA|||Extension Month 15; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.351|-1.296|
70875199|NCT00137046|141234547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.525|STANDARD_ERROR_OF_MEAN|0.267||||90.0|-0.965|-0.084|||ANCOVA|||Extension Month 18; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.084|-0.965|
70955851|NCT01144052|141415077|NON_INFERIORITY_OR_EQUIVALENCE|No statistical hypothesis tests for efficacy were performed, as this was pilot study serving to generate first data and hypotheses.||||||0.234||95.0|||||Wilcoxon (Mann-Whitney)|p-value refers to nT2L at month 12||||||0.234
71147735|NCT04684836|141789228|SUPERIORITY||Mean Difference (Net)|0.2014||||0.5954|TWO_SIDED|||||This is the fully adjusted regression model, which controlled for patient age group, gender, dual status, race, average percent of 65+ patients, risk score category, rural vs urban, and zip-code level characteristics.|Regression, Linear|||Difference-in-differences||||0.5954
70875200|NCT00137046|141234547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.647|STANDARD_ERROR_OF_MEAN|0.276||||90.0|-1.104|-0.191|||ANCOVA|||Extension Month 21; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.191|-1.104|
70875201|NCT00137046|141234547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.853|STANDARD_ERROR_OF_MEAN|0.295||||90.0|-1.34|-0.367|||ANCOVA|||Extension Month 24; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.367|-1.340|
70875202|NCT00137046|141234547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.303||||90.0|-0.89|0.111|||ANCOVA|||Extension Month 27; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.111|-0.890|
70875203|NCT00137046|141234547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.636|STANDARD_ERROR_OF_MEAN|0.293||||90.0|-1.119|-0.153|||ANCOVA|||Extension Month 30; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.153|-1.119|
70875204|NCT00137046|141234547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.522|STANDARD_ERROR_OF_MEAN|0.29||||90.0|-1.0|-0.043|||ANCOVA|||Extension Month 33; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.043|-1.000|
71147736|NCT02121535|141789308|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% confidence interval (CI) for the intra-subject ratio of the AUC0-tz were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|101.97|||||TWO_SIDED|90.0|98.94|105.08|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0-tz was a mixed effect model on the logarithmic scale.||105.08|98.94|
70875205|NCT00137046|141234547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.744|STANDARD_ERROR_OF_MEAN|0.346||||90.0|-1.315|-0.173|||ANCOVA|||Extension Month 36; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.173|-1.315|
71147737|NCT02121535|141789309|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the Cmax were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|103.77|||||TWO_SIDED|90.0|97.03|110.99|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of Cmax was a mixed effect model on the logarithmic scale.||110.99|97.03|
71147738|NCT02121535|141789310|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the AUC0-∞ were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|100.24|||||TWO_SIDED|90.0|96.8|103.8|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0--∞ was a mixed effect model on the logarithmic scale.||103.80|96.80|
71147739|NCT02121535|141789311|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the AUC0-∞ were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|99.42|||||TWO_SIDED|90.0|97.94|100.93|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0--∞ was a mixed effect model on the logarithmic scale.||100.93|97.94|
71147740|NCT02121535|141789312|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the AUC0-tz were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|99.5|||||TWO_SIDED|90.0|98.08|100.94|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0-tz was a mixed effect model on the logarithmic scale.||100.94|98.08|
71147741|NCT02121535|141789313|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the Cmax were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|100.07|||||TWO_SIDED|90.0|98.45|101.72|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of Cmax was a mixed effect model on the logarithmic scale.||101.72|98.45|
71147742|NCT02121535|141789314|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the Cmax were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|110.16|||||TWO_SIDED|90.0|106.87|113.54|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of Cmax was a mixed effect model on the logarithmic scale.||113.54|106.87|
71147743|NCT02121535|141789315|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the AUC0-tz were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|104.3|||||TWO_SIDED|90.0|102.53|106.1|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0-tz was a mixed effect model on the logarithmic scale.||106.10|102.53|
71147744|NCT02121535|141789316|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the AUC0-∞ were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|104.37|||||TWO_SIDED|90.0|102.68|106.1|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0--∞ was a mixed effect model on the logarithmic scale.||106.10|102.68|
71147745|NCT00091949|141789317|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||0.0067|TWO_SIDED|95.0|0.62|0.93||P-value adjusted for interim looks.|Regression, Cox||Pioglitazone arm compared to placebo; CI adjusted for interim looks.|||0.93|0.62|.0067
70875206|NCT00137046|141234547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.378|STANDARD_ERROR_OF_MEAN|0.628||||90.0|-2.42|-0.335|||ANCOVA|||Extension Month 39; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.335|-2.420|
70875207|NCT00137046|141234547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.28||||90.0|-1.183|-0.258|||ANCOVA|||Extension Month 39 (LOCF); Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.258|-1.183|
70875208|NCT00137046|141234547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.323||||90.0|-0.594|0.472|||ANCOVA|||Extension Follow Up Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.472|-0.594|
70875209|NCT02730455|141234560|SUPERIORITY||Odds Ratio (OR)|0.64||||0.086|TWO_SIDED|95.0|0.38|1.07|||Regression, Logistic|||Composite Measure: The global odds ratio was based on a linear logistic regression model with baseline National Institute of Health Stroke Scale (NIHSS) category (score 5-15, 16-23), age (\<60, 60-69, 70-80), tissue plasminogen activator (tPA) use (yes/no), treatment window (\<=9, \>9 and \<=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, United States of America \[USA\]) as covariates and unstructured working correlation structure||1.07|0.38|0.086
70875210|NCT02730455|141234560|SUPERIORITY||Odds Ratio (OR)|0.57||||0.031|TWO_SIDED|95.0|0.34|0.95|||Regression, Logistic|||Composite Measure: The global odds ratio was based on a linear logistic regression model with baseline NIHSS category (score 5-15, 16-23), age (\<60, 60-69, 70-80), tPA use (yes/no), treatment window (\<=9, \>9 and \<=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, USA) as covariates and unstructured working correlation structure||0.95|0.34|0.031
70875211|NCT02730455|141234561|SUPERIORITY||Odds Ratio (OR)|0.67||||0.222|TWO_SIDED|95.0|0.35|1.28|||Regression, Logistic|||The odds ratio was based on a linear logistic regression model with baseline NIHSS category (score 5-15, 16-23), age (\<60, 60-69, 70-80), tPA use (yes/no), treatment window (\<=9, \>9 and \<=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, USA) as covariates and unstructured working correlation structure||1.28|0.35|0.222
70955852|NCT00774930|141415095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0165|TWO_SIDED||||||ANCOVA|This analysis does not include any imputation for the early roll over subjects||||||0.0165
70955853|NCT00774930|141415096|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2544|||||||ANCOVA|ANCOVA included treatment group and 2 stratification variables at randomisation as factors and average frequency of diarrhoea per day during Screening||||||0.2544
70955854|NCT01177800|141415116|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
70955855|NCT01177800|141415117|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Non parametric ANOVA by van der Waerden|||Change at Week 10: p-value was calculated by Non parametric ANOVA by van der Waerden method.||||<0.001
70955856|NCT01177800|141415118|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
70955857|NCT01177800|141415119|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Non parametric ANOVA by van der Waerden|||Change at Week 26: p-value was calculated by Non parametric ANOVA by van der Waerden method.||||<0.001
70955858|NCT03527550|141415121|SUPERIORITY|||||||0.95|||||||ANOVA|Repeated-measures ANOVA. P-value reflects the significance of the interaction term (condition x time).||A 2 (condition: TAU, TAU + cognitive training) x 2 (time) repeated-measures Analysis of Variance (ANOVA) was used to test change in negative urgency at time 1 (admission) and time 2 (discharge), and whether participants differ in their average change in negative urgency as a function of condition (interaction of condition X time; reported below).||||0.95
70955859|NCT03527550|141415122|SUPERIORITY|||||||0.64|||||||ANOVA|Repeated-measures ANOVA. P-value reflects the significance of the interaction term (condition x time).||A 2 (condition: TAU, TAU + cognitive training) x 2 (time) repeated-measures Analysis of Variance (ANOVA) was used to test change in positive urgency at time 1 (admission) and time 2 (discharge), and whether participants differ in their average change in positive urgency as a function of condition (interaction of condition X time; reported below).||||0.64
70955860|NCT03527550|141415123|SUPERIORITY|||||||0.91||||||Repeated-measures ANOVA. P-value reflects the significance of the interaction term (condition x time).|ANOVA|||A 2 (condition: TAU, TAU + cognitive training) x 2 (time) repeated-measures Analysis of Variance (ANOVA) was used to test change in stop-signal reaction time at time 1 (admission) and time 2 (discharge), and whether participants differ in their average change in stop-signal reaction time as a function of condition (interaction of condition X time; reported below).||||0.91
70955861|NCT03527550|141415127|SUPERIORITY|||||||0.24|||||||ANOVA|Repeated-measures ANOVA. P-value reflects the significance of the interaction term (condition x time).||A 2 (condition: TAU, TAU + cognitive training) x 2 (time) repeated-measures Analysis of Variance (ANOVA) was used to test change in distress intolerance at time 1 (admission) and time 2 (discharge), and whether participants differ in their average change in distress intolerance as a function of condition (interaction of condition X time; reported below).||||.24
70955862|NCT01498679|141415136|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|51.0|||<|0.001|TWO_SIDED|95.0|42.2|59.7|||ANCOVA|||||59.7|42.2|<0.001
70955863|NCT00620282|141415172|SUPERIORITY_OR_OTHER||Least squares mean|7.43||||0.0549||95.0|-0.164|15.025||2-sided significance level of 5%.|ANCOVA|||Change in Ach-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.||15.025|-0.164|0.0549
70955864|NCT00620282|141415172|SUPERIORITY_OR_OTHER||Least squares mean|2.08||||0.5681||95.0|-5.215|9.375||2-sided significance level of 5%.|ANCOVA|||Change in Ach-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.||9.375|-5.215|0.5681
70955865|NCT00620282|141415172|SUPERIORITY_OR_OTHER||Least squares mean|5.35||||0.1668||95.0|-2.323|13.024||2-sided significance level of 5%.|ANCOVA|||Change in Ach-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.||13.024|-2.323|0.1668
70955866|NCT00620282|141415173|SUPERIORITY_OR_OTHER||Least squares mean|4.499||||0.2648||95.0|-3.535|12.534||2-sided significance level of 5%.|ANCOVA|||Change in SNP-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.||12.534|-3.535|0.2648
70955867|NCT00620282|141415173|SUPERIORITY_OR_OTHER||Least squares mean|0.709||||0.8518||95.0|-6.904|8.322||2-sided significance level of 5%.|ANCOVA|||Change in SNP-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.||8.322|-6.904|0.8518
70955868|NCT00620282|141415173|SUPERIORITY_OR_OTHER||Least squares mean|3.79||||0.3435||95.0|-4.194|11.774||2-sided significance level of 5%.|ANCOVA|||Change in SNP-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.||11.774|-4.194|0.3435
70955869|NCT00620282|141415174|SUPERIORITY_OR_OTHER||Least squares mean|-0.536||||0.0023||95.0|-0.868|-0.203||2-sided significance level of 5%.|ANCOVA|||Change in HbA1c from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.||-0.203|-0.868|0.0023
70955870|NCT00620282|141415174|SUPERIORITY_OR_OTHER||Least squares mean|-0.077||||0.6207||95.0|-0.391|0.236||2-sided significance level of 5%.|ANCOVA|||Change in HbA1c from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.||0.236|-0.391|0.6207
70955871|NCT00620282|141415174|SUPERIORITY_OR_OTHER||Least squares mean|-0.458||||0.0098||95.0|-0.8|-0.116||2-sided significance level of 5%.|ANCOVA|||Change in HbA1c from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.||-0.116|-0.8|0.0098
70875212|NCT02730455|141234561|SUPERIORITY||Odds Ratio (OR)|0.54||||0.073|TWO_SIDED|95.0|0.28|1.06|||Regression, Logistic|||The odds ratio was based on a linear logistic regression model with baseline NIHSS category (score 5-15, 16-23), age (\<60, 60-69, 70-80), tPA use (yes/no), treatment window (\<=9, \>9 and \<=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, USA) as covariates and unstructured working correlation structure||1.06|0.28|0.073
70875213|NCT02730455|141234562|SUPERIORITY||Odds Ratio (OR)|0.56||||0.085|TWO_SIDED|95.0|0.29|1.08|||Regression, Logistic|||The odds ratio was based on a linear logistic regression model with baseline NIHSS category (score 5-15, 16-23), age (\<60, 60-69, 70-80), tPA use (yes/no), treatment window (\<=9, \>9 and \<=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, USA) as covariates and unstructured working correlation structure.||1.08|0.29|0.085
70875214|NCT02730455|141234562|SUPERIORITY||Odds Ratio (OR)|0.54||||0.067|TWO_SIDED|95.0|0.28|1.04|||Regression, Logistic|||The odds ratio was based on a linear logistic regression model with baseline NIHSS category (score 5-15, 16-23), age (\<60, 60-69, 70-80), tPA use (yes/no), treatment window (\<=9, \>9 and \<=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, USA) as covariates and unstructured working correlation structure.||1.04|0.28|0.067
70875215|NCT02730455|141234563|SUPERIORITY||Adjusted Mean Difference|-7.7||||0.106|TWO_SIDED|95.0|-16.97|1.64|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (\<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.||1.64|-16.97|0.106
70875216|NCT02730455|141234563|SUPERIORITY||Adjusted Mean Difference|-6.1||||0.202|TWO_SIDED|95.0|-15.43|3.27|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (\<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.||3.27|-15.43|0.202
70875217|NCT02730455|141234564|SUPERIORITY||Adjusted Mean Difference|-0.3||||0.78|TWO_SIDED|95.0|-2.64|1.99|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (\<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.||1.99|-2.64|0.780
71147746|NCT00091949|141789318|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.19|TWO_SIDED|95.0|0.61|1.1||P-value adjusted for multiplicity (5 secondary outcomes).|Regression, Cox||Pioglitazone arm compared to placebo; conference interval (CI) adjusted for multiplicity (5 secondary outcomes).|||1.1|0.61|0.19
71147747|NCT00091949|141789319|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.11|TWO_SIDED|95.0|0.52|1.07||P-value adjusted for multiplicity (5 secondary outcomes).|Regression, Cox||Pioglitazone arm compared to placebo; CI adjusted for multiplicity (5 secondary outcomes).|||1.07|0.52|0.11
71147748|NCT00091949|141789321|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.52|TWO_SIDED|95.0|0.73|1.17||p-value adjusted for multiplicity (5 secondary outcomes)|Regression, Cox||Pioglitazone arm compared to placebo; CI adjusted for multiplicity (5 secondary outcomes).|||1.17|0.73|0.52
71147749|NCT00091949|141789322|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.023||||0.88|TWO_SIDED|95.0|-0.326|0.28|||Mixed Models Analysis||Pioglitazone arm compared to placebo.|Changes in modified mini-mental examination (3MS) score from baseline (to annual scores) were analyzed using a longitudinal repeated measures mixed effects model.||0.280|-0.326|0.88
71147750|NCT00091949|141789323|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.11|TWO_SIDED|95.0|0.65|1.05||P-value adjusted for multiplicity (5 secondary outcomes).|Regression, Cox||Pioglitazone arm compared to placebo; CI adjusted for multiplicity (5 secondary outcomes).|||1.05|0.65|0.11
71147751|NCT00906204|141789367|NON_INFERIORITY_OR_EQUIVALENCE|A one-sided alpha = 0.05, 85% power, an event rate of 0.70, equivalence margin of 0.20. Sample size = 75 patients per dose group, a total of 150 patients. Data analyzed will be counts of patients in each group who experience one or more component events of the primary endpoint during postoperative days one through seven. The DSMB requested an interim analysis after 80 patients and recommended ending the trial because the primary endpoint had been robustly reached.||||||0.64|TWO_SIDED||||||Fisher Exact|||The analysis compares the rates at which patients in each of the two groups cumulatively exceed the five composite endpoint thresholds. There are five safety outcomes monitored during the first seven post-transplantation days. The rates of observed vs. possible safety outcomes are compared.||||0.64
71147752|NCT00906204|141789368|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Log Rank|||||||0.35
71147753|NCT00906204|141789369|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||Log Rank|||||||0.47
70875218|NCT02730455|141234564|SUPERIORITY||Adjusted Mean Difference|-0.6||||0.622|TWO_SIDED|95.0|-2.89|1.73|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (\<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.||1.73|-2.89|0.622
70875219|NCT02730455|141234565|SUPERIORITY||Adjusted Mean Difference|1.2||||0.315|TWO_SIDED|95.0|-1.1|3.4|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (\<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.||3.40|-1.10|0.315
70875220|NCT02730455|141234565|SUPERIORITY||Adjusted Mean Difference|-0.7||||0.542|TWO_SIDED|95.0|-2.96|1.56|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (\<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.||1.56|-2.96|0.542
70875221|NCT02730455|141234568|SUPERIORITY|||||||0.028|||||||Cochran-Armitage trend test|||"mRS: The Cochran-Armitage trend test of a monotonically increasing dose response in proportion of excellent outcome.~Dose levels are log transformed."||||0.028
70875222|NCT02730455|141234568|SUPERIORITY|||||||0.049|||||||Cochran-Armitage trend test|||BI: The Cochran-Armitage trend test of a monotonically increasing dose response in proportion of excellent outcome. Dose levels are log transformed.||||0.049
70955872|NCT00620282|141415175|SUPERIORITY_OR_OTHER||Least squares mean|-35.605||||||95.0|-46.797|-24.413||2-sided significance level of 5%.|ANCOVA|||Change in FPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FPG as a covariate.||-24.413|-46.797|
71147754|NCT00906204|141789370|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Log Rank|||||||0.78
71147755|NCT00906204|141789371|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||Fisher Exact|||||||0.72
71147756|NCT00906204|141789372|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED||||||t-test, 2 sided|||||||0.85
71147757|NCT04328077|141789374|SUPERIORITY||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|9.44||0.7755|TWO_SIDED|95.0|-16.1|21.5|||ANCOVA|||||21.5|-16.1|0.7755
71147758|NCT04328077|141789374|SUPERIORITY||Mean Difference (Final Values)|-12.66|STANDARD_ERROR_OF_MEAN|9.369||0.1798|TWO_SIDED|95.0|-31.3|5.9|||ANCOVA|||||5.9|-31.3|0.1798
71147759|NCT04328077|141789374|SUPERIORITY||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|9.807||0.4229|TWO_SIDED|95.0|-27.4|11.6|||ANCOVA|||||11.6|-27.4|0.4229
71147760|NCT01347112|141789413|SUPERIORITY_OR_OTHER|||||||0.034||||||1 tailed fisher's exact test|Fisher Exact|1 tailed||||||0.034
71147761|NCT01347112|141789414|SUPERIORITY_OR_OTHER|||||||0.044||||||1 tailed fisher's exact|Fisher Exact|1 tailed||||||0.044
70875223|NCT03235154|141234571|OTHER|There was no comparator arm in this small single arm study||||||||||||No confidence intervals around point estimates provided given very small number of participants||||This was a single arm intervention study with a very small number of participants. Therefore, only descriptive statistics are provided.|No confidence intervals around point estimates provided given very small number of participants|||
70875224|NCT02725710|141234584|OTHER|||||||0.56|||||||Regression, Linear|||||||0.56
70875225|NCT01691781|141234607|SUPERIORITY|||||||0.049||||||This p-value reflects the difference in PTH means among participants with primary hyperparathyroidism|t-test, 2 sided|||The statistical analysis compared the change in PTH, before and after ACE inhibitor therapy, among participants with primary hyperparathyroidism.||||0.049
70875226|NCT01691781|141234607|SUPERIORITY|||||||0.8||||||This p-value reflects the difference in PTH means among normal control participants without primary hyperparathyroidism|t-test, 2 sided|||The statistical analysis compared the change in PTH, before and after ACE inhibitor therapy, among normal control participants (without primary hyperparathyroidism).||||0.80
70875227|NCT01691781|141234608|SUPERIORITY|||||||0.22||||||This p-value reflects the comparison of means among the primary hyperparathyroidism group only.|t-test, 2 sided|||The statistical analysis compared the change in urinary aldosterone excretion rate, before and after ACE inhibitor therapy, among participants with primary hyperparathyroidism.||||0.22
70875228|NCT01691781|141234608|SUPERIORITY|||||||0.86||||||This p-value reflects the mean difference in 24h aldosterone excretion rate among normal control participants without primary hyperparathyroidism|t-test, 2 sided|||The statistical analysis compared the change in urinary aldosterone excretion rate, before and after ACE inhibitor therapy, among normal control participants without primary hyperparathyroidism.||||0.86
70875229|NCT01691781|141234609|SUPERIORITY|||||||0.48||||||This p-value reflects the statistic for the comparison of mean calcium levels for the primary hyperparathyroidism group.|t-test, 2 sided|||The statistical analysis compared the change in serum calcium, before and after ACE inhibitor therapy, among participants with primary hyperparathyroidism.||||0.48
70875230|NCT01691781|141234609|SUPERIORITY|||||||0.8||||||This p-value reflects the statistic for the comparison of mean calcium levels for the normal control participants without primary hyperparathyroidism.|t-test, 2 sided|||The statistical analysis compared the change in serum calcium, before and after ACE inhibitor therapy, among normal control participants without primary hyperparathyroidism.||||0.80
70875231|NCT03978520|141234610|SUPERIORITY||Response Rate Difference|12.8|||=|0.081|TWO_SIDED|95.0|-1.6|27.1|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||27.1|-1.6|=0.081
70875232|NCT03978520|141234610|SUPERIORITY||Response Rate Difference|16.9|||=|0.028|TWO_SIDED|95.0|1.8|31.9|||Cochran-Mantel-Haenszel|||"Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||31.9|1.8|=0.028
70875233|NCT03978520|141234610|SUPERIORITY||Response Rate Difference|-4.7|||=|0.566|TWO_SIDED|95.0|-20.8|11.4|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||11.4|-20.8|=0.566
70875234|NCT03978520|141234611|SUPERIORITY||Response Rate Difference|18.3|||=|0.013|TWO_SIDED|95.0|3.9|32.6|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||32.6|3.9|=0.013
70875235|NCT03978520|141234611|SUPERIORITY||Response Rate Difference|18.1|||=|0.018|TWO_SIDED|95.0|3.0|33.2|||Cochran-Mantel-Haenszel|||"Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||33.2|3.0|=0.018
70875236|NCT03978520|141234611|SUPERIORITY||Response Rate Difference|-1.2|||=|0.882|TWO_SIDED|95.0|-17.6|15.2|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||15.2|-17.6|=0.882
70875237|NCT03978520|141234612|SUPERIORITY||Response Rate Difference|14.7|||=|0.049|TWO_SIDED|95.0|0.0|29.4|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||29.4|0.0|=0.049
71147762|NCT01347112|141789415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|90.0|-4.7|2.1|||||data were analyzed using analysis of covariance with treatment as the independent variable and the baseline value included as the co-variate|||2.1|-4.7|
70875238|NCT03978520|141234612|SUPERIORITY||Response Rate Difference|13.9|||=|0.091|TWO_SIDED|95.0|-2.2|30.1|||Cochran-Mantel-Haenszel|||"Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||30.1|-2.2|=0.091
70875239|NCT03978520|141234612|SUPERIORITY||Response Rate Difference|-6.3|||=|0.447|TWO_SIDED|95.0|-22.5|9.9|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs Elsubrutinib placebo/upadacitinib 30 mg~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||9.9|-22.5|=0.447
70875240|NCT03978520|141234613|SUPERIORITY||Response Rate Difference|16.7|||=|0.007|TWO_SIDED|95.0|4.5|28.9|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||28.9|4.5|=0.007
70875241|NCT03978520|141234613|SUPERIORITY||Response Rate Difference|31.0|||<|0.001|TWO_SIDED|95.0|18.1|44.0|||Cochran-Mantel-Haenszel|||Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo||44.0|18.1|<0.001
70875242|NCT03978520|141234613|SUPERIORITY||Response Rate Difference|-13.7|||=|0.068|TWO_SIDED|95.0|-28.4|1.0|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||1.0|-28.4|=0.068
70875243|NCT03978520|141234614|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.527|=|0.71|TWO_SIDED|95.0|-0.84|1.23|||Mixed-effect model repeat measurement|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~The Mixed-Effect Model Repeat Measurement model included fixed effects of Tx, visit and Tx-by-visit interaction, stratification factors (Baseline corticosteroid dose \> 10 mg prednisone-equivalent (≤ 10 mg or \>10 mg), screening SLEDAI-2K (\<10 or ≥ 10), baseline interferon score (high/low/NA, baseline immunosuppressant (yes/no)), and continuous fixed covariates of measurements at Baseline."||1.23|-0.84|=0.710
70875244|NCT03978520|141234614|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.545|=|0.963|TWO_SIDED|95.0|-1.05|1.1|||Mixed-effect model repeat measurement|||"Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~The Mixed-Effect Model Repeat Measurement model included fixed effects of Tx, visit and Tx-by-visit interaction, stratification factors (Baseline corticosteroid dose \> 10 mg prednisone-equivalent (≤ 10 mg or \>10 mg), screening SLEDAI-2K (\<10 or ≥ 10), baseline interferon score (high/low/NA, baseline immunosuppressant (yes/no)), and continuous fixed covariates of measurements at Baseline."||1.10|-1.05|=0.963
70875245|NCT03978520|141234614|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.547|=|0.754|TWO_SIDED|95.0|-0.9|1.25|||Mixed-effect model repeat measurement|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~The Mixed-Effect Model Repeat Measurement model included fixed effects of Tx, visit and Tx-by-visit interaction, stratification factors (Baseline corticosteroid dose \> 10 mg prednisone-equivalent (≤ 10 mg or \>10 mg), screening SLEDAI-2K (\<10 or ≥ 10), baseline interferon score (high/low/NA, baseline immunosuppressant (yes/no)), and continuous fixed covariates of measurements at Baseline."||1.25|-0.90|=0.754
70875246|NCT03978520|141234615|SUPERIORITY||Rate difference|-1.06|||=|0.002|TWO_SIDED|95.0|-1.74|-0.39|||Binomial regression|||"Mild/Moderate~ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs Elsubrutinib placebo/upadacitinib placebo~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||-0.39|-1.74|=0.002
70875247|NCT03978520|141234615|SUPERIORITY||Rate Difference|-0.69|||=|0.059|TWO_SIDED|95.0|-1.41|0.03|||Binomial regression|||"Mild/Moderate~Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||0.03|-1.41|=0.059
70875248|NCT03978520|141234615|SUPERIORITY||Rate Difference|-0.37|||=|0.252|TWO_SIDED|95.0|-1.01|0.27|||Binomial regression|||"Mild/Moderate~ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||0.27|-1.01|=0.252
70875249|NCT03978520|141234615|SUPERIORITY||Rate Difference|-0.1|||=|0.467|TWO_SIDED|95.0|-0.37|0.17|||Binomial regression|||"Severe~ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||0.17|-0.37|=0.467
70955873|NCT00620282|141415175|SUPERIORITY_OR_OTHER||Least squares mean|-9.653||||0.0677||95.0|-20.041|0.736||2-sided significance level of 5%.|ANCOVA|||Change in FPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FPG as a covariate.||0.736|-20.041|0.0677
70955874|NCT00620282|141415175|SUPERIORITY_OR_OTHER||Least squares mean|-25.952||||||95.0|-37.429|-14.475||2-sided significance level of 5%.|ANCOVA|||Change in FPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FPG as a covariate.||-14.475|-37.429|
70955875|NCT00620282|141415176|SUPERIORITY_OR_OTHER||Least squares mean|-11.871||||0.4121||95.0|-40.943|17.201||2-sided significance level of 5%.|ANCOVA|||Change in PPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline PPG as a covariate.||17.201|-40.943|0.4121
71147763|NCT00313014|141789471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.163|<|0.001|TWO_SIDED|95.0|-0.99|-0.35||P value was 2-sided and performed at the 5% error level.|Mixed Models Analysis|Repeated measures mixed linear model with treatment, time, and time by treatment interaction as fixed effects.||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||-0.35|-0.99|<.001
71147764|NCT00313014|141789471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.161|<|0.001|TWO_SIDED|95.0|-1.07|-0.44||P value was 2-sided and performed at the 5% error level.|Mixed Models Analysis|Repeated measures mixed linear model with treatment, time, and time by treatment interaction as fixed effect.||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||-0.44|-1.07|<.001
71147765|NCT00313014|141789472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.006|TWO_SIDED|95.0|-0.9|-0.13||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|ANCOVA||The analysis was based on the number of subjects who took \> 1 tablet of supplemental analgesia.|The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||-0.13|-0.90|.006
71147766|NCT00313014|141789472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.158|TWO_SIDED|95.0|-0.7|0.09||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|ANCOVA||The analysis was based on the number of subjects who took \> 1 tablet of supplemental analgesia.|The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||0.09|-0.70|.158
71147767|NCT00313014|141789473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72||||0.065|TWO_SIDED|95.0|-3.55|0.11||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|Mixed Models Analysis|||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||0.11|-3.55|.065
71147768|NCT00313014|141789473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99||||0.031||95.0|-3.79|-0.18||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|Mixed Models Analysis|||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||-0.18|-3.79|.031
71147769|NCT00313014|141789474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.23|STANDARD_ERROR_OF_MEAN|1.735|<|0.001|TWO_SIDED|95.0|-9.64|-2.82||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|Mixed Models Analysis|Mixed linear model: treatment, time as fixed effects, screening, prerandomization sleep disturbance subscale as covariates; subject as a random effect||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||-2.82|-9.64|<.001
71147770|NCT00313014|141789474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.65|STANDARD_ERROR_OF_MEAN|1.709||0.121||95.0|-6.01|0.7||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|Mixed Models Analysis|||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that BTDS 20 arm was different from the BTDS 5 arm.||0.70|-6.01|.121
70875250|NCT03978520|141234615|SUPERIORITY||Rate Difference|-0.26|||=|0.033|TWO_SIDED|95.0|-0.49|-0.02|||Binomial regression|||"Severe~Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||-0.02|-0.49|=0.033
70875251|NCT03978520|141234615|SUPERIORITY||Rate Difference|0.15|||=|0.156|TWO_SIDED|95.0|-0.06|0.37|||Binomial regression|||"Severe~ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||0.37|-0.06|=0.156
71147771|NCT01054885|141789475|SUPERIORITY_OR_OTHER||Least squares mean difference|0.046||||0.085|TWO_SIDED|95.0|-0.006|0.098|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.098|-0.006|0.085
71147772|NCT01054885|141789475|SUPERIORITY_OR_OTHER||Least squares mean difference|0.041||||0.123|TWO_SIDED|95.0|-0.011|0.093|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.093|-0.011|0.123
71147773|NCT01054885|141789475|SUPERIORITY_OR_OTHER||Least squares mean difference|0.185|||<|0.001|TWO_SIDED|95.0|0.133|0.237|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.237|0.133|<0.001
70875252|NCT03978520|141234615|SUPERIORITY||Rate Difference|-1.16|||=|0.002|TWO_SIDED|95.0|-1.89|-0.44|||Binomial regression|||"Overall~ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||-0.44|-1.89|=0.002
70875253|NCT03978520|141234615|SUPERIORITY||Rate Difference|-0.95|||=|0.014|TWO_SIDED|95.0|-1.7|-0.19|||Binomial regression|||"Overall~Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||-0.19|-1.70|=0.014
70955876|NCT00620282|141415176|SUPERIORITY_OR_OTHER||Least squares mean|3.815||||0.7622||95.0|-21.618|29.247||2-sided significance level of 5%|ANCOVA|||Change in PPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline PPG as a covariate.||29.247|-21.618|0.7622
70955877|NCT00620282|141415176|SUPERIORITY_OR_OTHER||Least squares mean|-15.686||||0.2651||95.0|-43.838|12.466||2-sided significance level of 5%.|ANCOVA|||Change in PPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline PPG as a covariate.||12.466|-43.838|0.2651
70955878|NCT00620282|141415177|SUPERIORITY_OR_OTHER||Least squares mean|-1.528||||0.0268||95.0|-2.873|-0.184||2-sided significance level of 5%.|ANCOVA|||Change in body weight from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline body weight as a covariate.||-0.184|-2.873|0.0268
70955879|NCT00620282|141415177|SUPERIORITY_OR_OTHER||Least squares mean|-2.859||||||95.0|-4.139|-1.579||2-sided significance level of 5%.|ANCOVA|||Change in body weight from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline body weight as a covariate.||-1.579|-4.139|
70955880|NCT00620282|141415177|SUPERIORITY_OR_OTHER||Least squares mean|1.331||||0.0486||95.0|0.009|2.653||2-sided significance level of 5%.|ANCOVA|||Change in body weight from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline body weight as a covariate.||2.653|0.0090|0.0486
70955881|NCT00620282|141415178|SUPERIORITY_OR_OTHER||Least squares mean|-2.237||||0.7736||95.0|-17.829|13.354||2-sided significance level of 5%.|ANCOVA|||Change in TC from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TC as a covariate.||13.354|-17.829|0.7736
70955882|NCT00620282|141415178|SUPERIORITY_OR_OTHER||Least squares mean|1.912||||0.7993||95.0|-13.168|16.991||2-sided significance level of 5%.|ANCOVA|||Change in TC from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TC as a covariate.||16.991|-13.168|0.7993
70955883|NCT00620282|141415178|SUPERIORITY_OR_OTHER||Least squares mean|-4.149||||0.5903||95.0|-19.582|11.284||2-sided significance level of 5%.|ANCOVA|||Change in TC from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TC as a covariate.||11.284|-19.582|0.5903
70955884|NCT00620282|141415179|SUPERIORITY_OR_OTHER||Least squares mean|3.702||||0.5583||95.0|-8.96|16.365||2-sided significance level of 5%.|ANCOVA|||Change in LDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline LDL-C as a covariate.||16.365|-8.96|0.5583
70955885|NCT00620282|141415179|SUPERIORITY_OR_OTHER||Least squares mean|2.773||||0.6517||95.0|-9.537|15.082||2-sided significance level of 5%.|ANCOVA|||Change in LDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline LDL-C as a covariate.||15.082|-9.537|0.6517
70955886|NCT00620282|141415179|SUPERIORITY_OR_OTHER||Least squares mean|0.929||||0.8822||95.0|-11.646|13.505||2-sided significance level of 5%.|ANCOVA|||Change in LDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline LDL-C as a covariate.||13.505|-11.646|0.8822
70955887|NCT00620282|141415180|SUPERIORITY_OR_OTHER||Least squares mean|-0.169||||0.9131||95.0|-3.273|2.935||2-sided significance level of 5%.|ANCOVA|||Change in HDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HDL-C as a covariate.||2.935|-3.273|0.9131
70955888|NCT00620282|141415180|SUPERIORITY_OR_OTHER||Least squares mean|-0.723||||0.6362||95.0|-3.785|2.339||2-sided significance level of 5%.|ANCOVA|||Change in HDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HDL-C as a covariate.||2.339|-3.785|0.6362
70955889|NCT00620282|141415180|SUPERIORITY_OR_OTHER||Least squares mean|0.554||||0.7283||95.0|-2.643|3.751||2-sided significance level of 5%.|ANCOVA|||Change in HDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HDL-C as a covariate.||3.751|-2.643|0.7283
70955890|NCT00620282|141415181|SUPERIORITY_OR_OTHER||Least squares mean|-36.709||||0.0694||95.0|-76.467|3.048||2-sided significance level of 5%.|ANCOVA|||Change in TG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TG as a covariate.||3.048|-76.467|0.0694
70955891|NCT00620282|141415181|SUPERIORITY_OR_OTHER||Least squares mean|-3.786||||0.844||95.0|-42.373|34.801||2-sided significance level of 5%.|ANCOVA|||Change in TG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TG as a covariate.||34.801|-42.373|0.844
70955892|NCT00620282|141415181|SUPERIORITY_OR_OTHER||Least squares mean|-32.923||||0.0994||95.0|-72.353|6.507||2-sided significance level of 5%.|ANCOVA|||Change in TG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TG as a covariate.||6.507|-72.353|0.0994
70955893|NCT00620282|141415182|SUPERIORITY_OR_OTHER||Least squares mean|-0.42||||0.2282||95.0|-1.118|0.278||2-sided significance level of 5%.|ANCOVA|||Change in TNF-alpha from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TNF-alpha as a covariate.||0.278|-1.118|0.2282
71147774|NCT01054885|141789475|SUPERIORITY_OR_OTHER||Least squares mean difference|0.214|||<|0.001|TWO_SIDED|95.0|0.161|0.266||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.266|0.161|<0.001
70955894|NCT00620282|141415182|SUPERIORITY_OR_OTHER||Least squares mean|-0.018||||0.9569||95.0|-0.697|0.661||2-sided significance level of 5%.|ANCOVA|||Change in TNF-alpha from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TNF-alpha as a covariate.||0.661|-0.697|0.9569
70955895|NCT00620282|141415182|SUPERIORITY_OR_OTHER||Least squares mean|-0.402||||0.2465||95.0|-1.097|0.293||2-sided significance level of 5%.|ANCOVA|||Change in TNF-alpha from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TNF-alpha as a covariate.||0.293|-1.097|0.2465
70955896|NCT00548262|141415192|SUPERIORITY_OR_OTHER||percentage of participants with success|59.1|||||TWO_SIDED|95.0|44.6|73.6|||||95% CI based on normal approximation to the binomial.|Success at EOT||73.6|44.6|
70955897|NCT00548262|141415193|SUPERIORITY_OR_OTHER||percentage of participants with success|59.1|||||TWO_SIDED|95.0|44.6|73.6|||||95% CI based on normal approximation to the binomial.|EIVT Success||73.6|44.6|
71147775|NCT01054885|141789475|SUPERIORITY_OR_OTHER||Least squares mean difference|0.209|||<|0.001|TWO_SIDED|95.0|0.157|0.261|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.261|0.157|<0.001
71147776|NCT01054885|141789475|SUPERIORITY_OR_OTHER||Least squares mean difference|0.168|||<|0.001|TWO_SIDED|95.0|0.116|0.22||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.220|0.116|<0.001
71147777|NCT01054885|141789475|SUPERIORITY_OR_OTHER||Least squares mean difference|0.168|||<|0.001|TWO_SIDED|95.0|0.117|0.219|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.219|0.117|<0.001
71147778|NCT01054885|141789475|SUPERIORITY_OR_OTHER||Least squares mean difference|0.029||||0.274|TWO_SIDED|95.0|-0.023|0.081|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.081|-0.023|0.274
71147779|NCT01054885|141789475|SUPERIORITY_OR_OTHER||Least squares mean difference|0.024||||0.357|TWO_SIDED|95.0|-0.027|0.075|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.075|-0.027|0.357
71147780|NCT01054885|141789476|SUPERIORITY_OR_OTHER||Least squares mean difference|0.044||||0.095|TWO_SIDED|95.0|-0.008|0.097|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.097|-0.008|0.095
71147781|NCT01054885|141789476|SUPERIORITY_OR_OTHER||Least squares mean difference|0.008||||0.756|TWO_SIDED|95.0|-0.044|0.06|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.060|-0.044|0.756
71147782|NCT01054885|141789476|SUPERIORITY_OR_OTHER||Least squares mean difference|0.1|||<|0.001|TWO_SIDED|95.0|0.048|0.151|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.151|0.048|<0.001
71147783|NCT01054885|141789476|SUPERIORITY_OR_OTHER||Least squares mean difference|0.144|||<|0.001|TWO_SIDED|95.0|0.091|0.197||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.197|0.091|<0.001
71147784|NCT01054885|141789476|SUPERIORITY_OR_OTHER||Least squares mean difference|0.131|||<|0.001|TWO_SIDED|95.0|0.08|0.183|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.183|0.080|<0.001
71147785|NCT01054885|141789476|SUPERIORITY_OR_OTHER||Least squares mean difference|0.1|||<|0.001|TWO_SIDED|95.0|0.047|0.152||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.152|0.047|<0.001
71147786|NCT01054885|141789476|SUPERIORITY_OR_OTHER||Least squares mean difference|0.123|||<|0.001|TWO_SIDED|95.0|0.072|0.174||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.174|0.072|<0.001
70955898|NCT00548262|141415193|SUPERIORITY_OR_OTHER||percentage of participants with success|47.7|||||TWO_SIDED|95.0|33.0|62.5|||||95% CI based on normal approximation to the binomial.|Week 2 Follow-up Success||62.5|33.0|
70955899|NCT00548262|141415194|SUPERIORITY_OR_OTHER||percentage of participants with success|52.4|||||TWO_SIDED|95.0|31.0|73.7|||||95% CI based on normal approximation to the binomial.|Candida albicans: Success||73.7|31.0|
70955900|NCT00548262|141415194|SUPERIORITY_OR_OTHER||percentage of participants with success|50.0|||||TWO_SIDED|95.0|0.0|100.0|||||95% CI based on normal approximation to the binomial.|Candida famata: Success||100.0|0.0|
70875254|NCT03978520|141234615|SUPERIORITY||Rate Difference|-0.22|||=|0.526|TWO_SIDED|95.0|-0.89|0.46|||Binomial regression|||"Overall~ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||0.46|-0.89|=0.526
70875255|NCT00064844|141234734|SUPERIORITY_OR_OTHER_LEGACY||chi square|7.25|||<|0.01||95.0|||||Chi-squared|df = 1, N = 96||||||<0.01
70875256|NCT02700815|141234735|SUPERIORITY||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.277||0.0303|TWO_SIDED|95.0|-1.15|-0.06|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between placebo and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.||-0.06|-1.15|0.0303
70875257|NCT02700815|141234735|SUPERIORITY||Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.197||0.2886|TWO_SIDED|95.0|-0.18|0.6|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between capsaicin and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.||0.60|-0.18|0.2886
70875258|NCT02700815|141234735|SUPERIORITY||Mean Difference (Net)|-0.72|STANDARD_ERROR_OF_MEAN|0.197||0.0003|TWO_SIDED|95.0|-1.1|-0.33|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between diclofenac and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.||-0.33|-1.10|0.0003
70875259|NCT02700815|141234736|SUPERIORITY||Mean Difference (Net)|-0.37|STANDARD_ERROR_OF_MEAN|0.221||0.0956|TWO_SIDED|95.0|-0.8|0.07|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-72 h) between placebo and combination therapy diclofenac + capsaicin||0.07|-0.80|0.0956
70875260|NCT02700815|141234736|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.157||0.0564|TWO_SIDED|95.0|-0.01|0.61|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-72 h) between capsaicin and combination therapy diclofenac + capsaicin||0.61|-0.01|0.0564
70875261|NCT02700815|141234736|SUPERIORITY||Mean Difference (Net)|-0.56|STANDARD_ERROR_OF_MEAN|0.157||0.0004|TWO_SIDED|95.0|-0.87|-0.25|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-72 h) between diclofenac and combination therapy diclofenac + capsaicin||-0.25|-0.87|0.0004
70875262|NCT02700815|141234737|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.238||0.0347|TWO_SIDED|95.0|-0.97|-0.04|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-120 h) between placebo and combination therapy diclofenac + capsaicin||-0.04|-0.97|0.0347
70875263|NCT02700815|141234737|SUPERIORITY||Mean Difference (Net)|0.32|STANDARD_ERROR_OF_MEAN|0.169||0.0622|TWO_SIDED|95.0|-0.02|0.65|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-120 h) between capsaicin and combination therapy diclofenac + capsaicin||0.65|-0.02|0.0622
70875264|NCT02700815|141234737|SUPERIORITY||Mean Difference (Net)|-0.68|STANDARD_ERROR_OF_MEAN|0.169|<|0.0001|TWO_SIDED|95.0|-1.01|-0.35|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-120 h) between diclofenac and combination therapy diclofenac + capsaicin||-0.35|-1.01|<0.0001
70875265|NCT02700815|141234738|SUPERIORITY||Odds Ratio (OR)|1.882||||0.0202|TWO_SIDED|95.0|1.1|3.21|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 30% from baseline between placebo and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.||3.21|1.10|0.0202
70875266|NCT02700815|141234738|SUPERIORITY||Odds Ratio (OR)|0.732||||0.1206|TWO_SIDED|95.0|0.49|1.09|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 30% from baseline between capsaicin and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.||1.09|0.49|0.1206
70875267|NCT02700815|141234738|SUPERIORITY||Odds Ratio (OR)|1.629||||0.0122|TWO_SIDED|95.0|1.11|2.39|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 30% from baseline between diclofenac and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.||2.39|1.11|0.0122
70955901|NCT00548262|141415194|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Candida glabrata: Success||100.0|13.3|
70955902|NCT00548262|141415194|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Candida krusei: Success||100.0|13.3|
71147787|NCT01054885|141789476|SUPERIORITY_OR_OTHER||Least squares mean difference|0.045||||0.093|TWO_SIDED|95.0|-0.008|0.097|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.097|-0.008|0.093
71147788|NCT01054885|141789476|SUPERIORITY_OR_OTHER||Least squares mean difference|0.032||||0.224|TWO_SIDED|95.0|-0.019|0.083|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.083|-0.019|0.224
71147789|NCT03881852|141789480|SUPERIORITY||||||<|0.001||||||P-value calculated from LSMean|Mixed Models Analysis|||||||<0.001
71147790|NCT01421719|141789481|SUPERIORITY_OR_OTHER|||||||0.0087||95.0|||||t-test, 2 sided|||Paired t test comparison of baseline number of urinary leaks per day versus number of leaks per day at 6 month evaluation after treatment.||||0.0087
71147791|NCT04226742|141789516|SUPERIORITY||Mean Difference (Net)|0.58||||0.79|TWO_SIDED|95.0|-3.71|4.88||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||||4.88|-3.71|0.79
71147792|NCT04226742|141789517|SUPERIORITY||Mean Difference (Net)|0.9||||0.61|TWO_SIDED|95.0|-2.52|4.32||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||||4.32|-2.52|.61
71147793|NCT04226742|141789518|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.088|TWO_SIDED|95.0|-0.05|0.68||Significance threshold of alpha = 0.05|Mixed Models Analysis|||||0.68|-0.05|0.088
71147794|NCT04226742|141789519|SUPERIORITY||Mean Difference (Final Values)|13.68||||0.142|TWO_SIDED|95.0|-4.62|31.99||Threshold for statistical significance of alpha = 0.05|Mixed Models Analysis|||||31.99|-4.62|0.142
70875268|NCT02700815|141234739|SUPERIORITY||Odds Ratio (OR)|1.729||||0.0643|TWO_SIDED|95.0|0.97|3.09|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 50% from baseline between placebo and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.||3.09|0.97|0.0643
70875269|NCT02700815|141234739|SUPERIORITY||Odds Ratio (OR)|0.833||||0.3479|TWO_SIDED|95.0|0.57|1.22|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 50% from baseline between capsaicin and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.||1.22|0.57|0.3479
70875270|NCT02700815|141234739|SUPERIORITY||Odds Ratio (OR)|2.125||||0.0004|TWO_SIDED|95.0|1.4|3.22|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 50% from baseline between diclofenac and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.||3.22|1.40|0.0004
70875271|NCT02700815|141234740|SUPERIORITY||Mean Difference (Net)|-1.05|STANDARD_ERROR_OF_MEAN|0.313||0.0008|TWO_SIDED|95.0|-1.67|-0.44|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between placebo and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.||-0.44|-1.67|0.0008
70875272|NCT02700815|141234740|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.223||0.3726|TWO_SIDED|95.0|-0.24|0.64|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between capsaicin and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.||0.64|-0.24|0.3726
70875273|NCT02700815|141234740|SUPERIORITY||Mean Difference (Net)|-1.12|STANDARD_ERROR_OF_MEAN|0.223|<|0.0001|TWO_SIDED|95.0|-1.56|-0.68|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between diclofenac and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.||-0.68|-1.56|<0.0001
70875274|NCT02700815|141234741|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.844||0.881|TWO_SIDED|95.0|-1.78|1.53|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between placebo and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.||1.53|-1.78|0.8810
70955903|NCT00548262|141415194|SUPERIORITY_OR_OTHER||percentage of participants with success|16.7|||||TWO_SIDED|95.0|0.0|46.5|||||95% CI based on normal approximation to the binomial.|Candida parapsilosis: Success||46.5|0.0|
71147795|NCT04226742|141789520|SUPERIORITY||Mean Difference (Final Values)|-6.87||||0.109|TWO_SIDED|95.0|-15.28|1.54||Threshold for statistical significance of alpha = .05|Mixed Models Analysis|||||1.54|-15.28|0.109
71147796|NCT04226742|141789521|SUPERIORITY||Mean Difference (Final Values)|-1.01||||0.736|TWO_SIDED|95.0|-6.92|4.89|||Mixed Models Analysis|||||4.89|-6.92|0.736
71147797|NCT01391546|141789550|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was achieved if the lower bound of the 2-sided 95% confidence interval (CI) for the GMT ratio was greater than 2/3|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.93|1.18|||longitudinal regression model|Model adjusted for pre-vaccination titres and age at vaccination in years|GMT ratio = GMT IM route divided by GMT SC route|||1.18|0.93|<0.001
71147798|NCT01391546|141789551|SUPERIORITY_OR_OTHER||GMFR|2.7|||||TWO_SIDED|95.0|2.4|3.0|||||GMFR = GMT Post-vaccination/GMT Pre-vaccination|Acceptability was demonstrated if the lower bound of the two-sided 95% CI was \>1.4||3.0|2.4|
71147799|NCT04225897|141789632|OTHER||Difference|-8.02|||||TWO_SIDED|95.0|-31.78|15.74||||||60 hours. Analysis was performed using mixed effects analysis of covariance model on change from baseline in viral load, including a random effect for participant and fixed effects for treatment group, baseline human rhinovirus/enterovirus status (present or absent), visit, vist by treatment group interaction, and baseline viral load as a covariate.||15.74|-31.78|
71147800|NCT04225897|141789632|OTHER||Difference|-15.22|||||TWO_SIDED|95.0|-40.15|9.7|||Mixed effects analysis of covariance|||156 hours. Analysis was performed using mixed effects analysis of covariance model on change from baseline in viral load, including a random effect for participant and fixed effects for treatment group, baseline human rhinovirus/enterovirus status (present or absent), visit, vist by treatment group interaction, and baseline viral load as a covariate.||9.70|-40.15|
71147801|NCT04225897|141789633|OTHER||Difference|14.82|||||TWO_SIDED|95.0|-91.68|121.33||||||60 hours. Analysis was performed using mixed effects analysis of covariance model on change from baseline in viral load, including a random effect for participant and fixed effects for treatment group, baseline human rhinovirus/enterovirus status (present or absent), visit, vist by treatment group interaction, and baseline viral load as a covariate.||121.33|-91.68|
71147802|NCT04225897|141789633|OTHER||Difference|-31.19|||||TWO_SIDED|95.0|-143.96|81.57||||||156 hours. Analysis was performed using mixed effects analysis of covariance model on change from baseline in viral load, including a random effect for participant and fixed effects for treatment group, baseline human rhinovirus/enterovirus status (present or absent), visit, vist by treatment group interaction, and baseline viral load as a covariate.||81.57|-143.96|
70875275|NCT02700815|141234741|SUPERIORITY||Mean Difference (Net)|0.31|STANDARD_ERROR_OF_MEAN|0.601||0.6094|TWO_SIDED|95.0|-0.87|1.49|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between capsaicin and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.||1.49|-0.87|0.6094
70875276|NCT02700815|141234741|SUPERIORITY||Mean Difference (Net)|0.76|STANDARD_ERROR_OF_MEAN|0.602||0.2047|TWO_SIDED|95.0|-0.42|1.95|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between diclofenac and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.||1.95|-0.42|0.2047
70955904|NCT00548262|141415194|SUPERIORITY_OR_OTHER||percentage of participants with success|80.0|||||TWO_SIDED|95.0|55.2|100.0|||||95% CI based on normal approximation to the binomial.|Candida tropicalis: Success||100.0|55.2|
70875277|NCT02700815|141234742|SUPERIORITY||Mean Difference (Net)|1.65|STANDARD_ERROR_OF_MEAN|1.339||0.2193|TWO_SIDED|95.0|-0.98|4.27|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between placebo and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.||4.27|-0.98|0.2193
70875278|NCT02700815|141234742|SUPERIORITY||Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.949||0.7672|TWO_SIDED|95.0|-1.58|2.15|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between capsaicin and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.||2.15|-1.58|0.7672
70955905|NCT00548262|141415194|SUPERIORITY_OR_OTHER||percentage of participants with success|57.1|||||TWO_SIDED|95.0|20.5|93.8|||||95% CI based on normal approximation to the binomial.|Unidentifiable: Success||93.8|20.5|
70955906|NCT00548262|141415195|SUPERIORITY_OR_OTHER||percentage of participants with success|52.4|||||TWO_SIDED|95.0|31.0|73.7|||||95% CI based on normal approximation to the binomial.|Candida albicans: Success||73.7|31.0|
71147803|NCT01285323|141789680|SUPERIORITY_OR_OTHER_LEGACY||CAE rate ratio (reslizumab vs placebo)|0.4063|||<|0.0001|TWO_SIDED|95.0|0.2819|0.5855||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.||0.5855|0.2819|<0.0001
71147804|NCT01285323|141789681|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.0397||0.0109|TWO_SIDED|95.0|0.023|0.179||Statistical significance at \<=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active - placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.||0.179|0.023|0.0109
71147805|NCT01285323|141789682|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.0317||0.0037|TWO_SIDED|95.0|0.03|0.155||Statistical significance at \<=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active-placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.||0.155|0.030|0.0037
71147806|NCT01285323|141789683|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.937||0.0259|TWO_SIDED|95.0|0.025|0.393||Statistical significance at \<=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active - placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.||0.393|0.025|0.0259
71147807|NCT01285323|141789684|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.196|STANDARD_ERROR_OF_MEAN|0.0664||0.0032|TWO_SIDED|95.0|-0.327|-0.066||Statistical significance at \<=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active - placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.||-0.066|-0.327|0.0032
71147808|NCT01285323|141789685|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.486|||<|0.0001|TWO_SIDED|95.0|0.353|0.67|||Regression, Cox|Stratified by baseline usage of oral corticosteroid (yes or no) and geographical region (US or other).|Reslizumab vs placebo|Kaplan-Meier estimate of probability (5) of not experiencing a CAE by week 52. The first CAEs for each patient occurring after randomization and up to 2 weeks after the end of treatment period were analyzed. Patients without a CAE within this time frame were censored at two weeks after the treatment completion date or study discontinuation, whichever came first.||0.670|0.353|<0.0001
71147809|NCT01285323|141789686|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.012||0.0037|TWO_SIDED|95.0|0.011|0.059||Statistical significance at \<=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active - placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.||0.059|0.011|0.0037
71147810|NCT01285323|141789687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.062|STANDARD_ERROR_OF_MEAN|0.1775||0.7263|TWO_SIDED|95.0|-0.411|0.287||Statistical significance at \<=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active - placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.||0.287|-0.411|0.7263
70875279|NCT02700815|141234742|SUPERIORITY||Mean Difference (Net)|2.02|STANDARD_ERROR_OF_MEAN|0.95||0.0339|TWO_SIDED|95.0|0.15|3.88|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between diclofenac and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.||3.88|0.15|0.0339
70955907|NCT00548262|141415195|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Candida glabrata: Success||100.0|13.3|
70955908|NCT00548262|141415195|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Candida krusei: Success||100.0|13.3|
70875280|NCT00524368|141234743|NON_INFERIORITY_OR_EQUIVALENCE|If at Week 48, the lower limit of the 95% two-sided confidence interval of the difference between DRV/rtv once daily and DRV/rtv twice daily exceeds -12%, non-inferiority of the DRV/rtv q.d. versus the DRV/rtv b.i.d. therapy was concluded.|Difference in proportion of response|0.0019|STANDARD_ERROR_OF_MEAN|0.037|<|0.001|TWO_SIDED|95.0|-0.054|0.092|||Regression, Logistic|The model includes treatment as factor and baseline viral load (log10) as covariate.|Difference in proportion of response DRV/rtv once daily minus DRV/rtv twice daily estimated from the logistic regression model.|Assuming a response rate of 70% at 48 weeks for both treatment groups, 306 participants were required per treatment arm to establish noninferiority of darunavir (DRV)/ritonavir (rtv) once daily versus DRV/rtv twice daily with a maximum allowable difference of 12%, with a 1-sided significance level of 0.025 and 90% power.||0.092|-0.054|<0.001
70875281|NCT00524368|141234744|NON_INFERIORITY_OR_EQUIVALENCE|If at Week 48, the lower limit of this 95% 2-sided CI of the difference between DRV/rtv q.d. and DRV/rtv b.i.d. exceeded -12%, noninferiority of DRV/rtv q.d. and DRV/rtv b.i.d. could be concluded.|Difference in proportion of response|0.007|STANDARD_ERROR_OF_MEAN|0.034|<|0.001|TWO_SIDED|95.0|-0.06|0.075|||Regression, Logistic|A logistic regression model includes treatment as fixed factor and baseline plasma viral load as a covariate.|Difference in proportion of response between 2 treatment groups (DRV/rtv q.d. minus DRV/rtv b.i.d)|||0.075|-0.060|<0.001
70875282|NCT00524368|141234745|SUPERIORITY_OR_OTHER||Difference between least square means|-0.003|STANDARD_ERROR_OF_MEAN|0.094||0.977|TWO_SIDED|95.0|-0.188|0.182|||ANCOVA|Including 1 factor for treatment, and including the covariate baseline log10 plasma viral load|Difference between least square means between the DRV/rtv q.d. and DRV/rtv b.i.d. treatment groups at Week 48.|||0.182|-0.188|0.977
70875283|NCT00524368|141234746|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99|STANDARD_ERROR_OF_MEAN|0.094||0.917|TWO_SIDED|95.0|0.824|1.191|||Cox proportional hazards|Including treatment as fixed factor and baseline plasma viral load as a covariate||||1.191|0.824|0.917
70875284|NCT00524368|141234747|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.945|STANDARD_ERROR_OF_MEAN|0.154||0.716|TWO_SIDED|95.0|0.699|1.279|||Regression, Cox|Including baseline log10 viral load as covariate||||1.279|0.699|0.716
70875285|NCT00524368|141234748|SUPERIORITY_OR_OTHER||Difference in least square means|-0.03|STANDARD_ERROR_OF_MEAN|0.072||0.711|TWO_SIDED|95.0|-0.169|0.115|||ANCOVA|Including 1 factor for treatment, and including the covariate baseline log10 plasma viral load|Difference in least square means between the 2 treatment groups (DRV/rtv q.d. and DRV/rtv b.i.d)|||0.115|-0.169|0.711
70955909|NCT00548262|141415195|SUPERIORITY_OR_OTHER||percentage of participants with success|16.7|||||TWO_SIDED|95.0|0.0|46.5|||||95% CI based on normal approximation to the binomial.|Candida parapsilosis: Success||46.5|0.0|
70875286|NCT00524368|141234749|SUPERIORITY_OR_OTHER||Difference in least square means|-5.95|STANDARD_ERROR_OF_MEAN|10.26||0.562|TWO_SIDED|95.0|-26.09|14.2|||ANCOVA|The model includes treatment as factor and baseline CD4 count and baseline viral load (log10) as covariates.|Difference in least square means DRV/rtv once daily minus DRV/rtv twice daily estimated from the ANCOVA model.|||14.20|-26.09|0.562
70875287|NCT00524368|141234750|SUPERIORITY_OR_OTHER||Difference in least square means|0.55|STANDARD_ERROR_OF_MEAN|1.79||0.761|TWO_SIDED|95.0|-2.97|4.06|||ANCOVA|Including factors for treatment, and baseline log10 plasma viral load and baseline FAHI score as covariates|Difference in least square means DRV/rtv once daily minus DRV/rtv twice daily estimated from the ANCOVA model.|||4.06|-2.97|0.761
70955910|NCT00548262|141415195|SUPERIORITY_OR_OTHER||percentage of participants with success|80.0|||||TWO_SIDED|95.0|55.2|100.0|||||95% CI based on normal approximation to the binomial.|Candida tropicalis: Success||100.0|55.2|
71147811|NCT01285323|141789690|SUPERIORITY_OR_OTHER_LEGACY||CAE rate ratio (reslizumab vs placebo)|0.3893|||<|0.0001|TWO_SIDED|95.0|0.2621|0.5782||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||CAE Due to Requiring Systemic Corticosteroids The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.||0.5782|0.2621|<0.0001
71147812|NCT01285323|141789690|SUPERIORITY_OR_OTHER_LEGACY||CAE rate ratio|0.6686||||0.402|TWO_SIDED|95.0|0.2878|1.6479||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||CAE Due to Hospitalization or ER visit The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.||1.6479|0.2878|0.4020
71147813|NCT02703597|141789694|SUPERIORITY||Odds Ratio (OR)|1.15||||0.8|TWO_SIDED|95.0|0.32|4.2|||Mixed Models Analysis|||"Hypothesis: Participants in the GSA-ASPIRE-Network Group will be more likely to decrease in susceptibility to vaping than participants in the ASPIRE group.~The statistical analysis was conducted for 10 out of the 15 participating sites, to avoid bias with respect to the sites that participated in different conditions (i.e., 1 site in a school classroom during class time and 4 sites in the summer camp during summer time)."||4.20|0.32|0.80
71147814|NCT02703597|141789694|SUPERIORITY||Odds Ratio (OR)|0.17|||<|0.01|TWO_SIDED|95.0|0.06|0.43|||Mixed Models Analysis|||"Hypothesis: Participants in both arms will decrease in susceptibility to vaping over time.~The statistical analysis was conducted for 10 out of the 15 participating sites, to avoid bias with respect to the sites that participated in different conditions (i.e., 1 site in a school classroom during class time and 4 sites in the summer camp during summer time)."||0.43|0.06|<0.01
71147815|NCT02703597|141789695|SUPERIORITY||Odds Ratio (OR)|0.76||||0.7|TWO_SIDED|95.0|0.16|3.49|||Mixed Models Analysis|||"Hypothesis: Adolescents who participated in the GSA-ASPIRE-Network group will be more likely to decrease in susceptibility to using conventional tobacco than adolescents who participated in the ASPIRE group.~The statistical analysis was conducted for 10 out of the 15 participating sites, to avoid bias with respect to the sites that participated in different conditions (i.e., 1 site in a school classroom during class time and 4 sites in the summer camp during summer time)."||3.49|0.16|0.70
71147816|NCT02703597|141789695|SUPERIORITY||Odds Ratio (OR)|0.13|||<|0.01|TWO_SIDED|95.0|0.04|0.4|||Mixed Models Analysis|||"Hypothesis: Participants in both arms will decrease in susceptibility of using conventional tobacco over time.~The statistical analysis was conducted for 10 out of the 15 participating sites, to avoid bias with respect to the sites that participated in different conditions (i.e., 1 site in a school classroom during class time and 4 sites in the summer camp during summer time)."||0.40|0.04|<0.01
71147817|NCT02606643|141789696|SUPERIORITY_OR_OTHER|||||||0.814|||||||Chi-squared|||an alpha level of .05, and a level of power of 80%. These parameters required a sample size of 63 patients per group||||0.814
71147818|NCT00089752|141789721|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was designed to achieve at least 80% power, using n 1⁄4 123 per group with an effect size of at least 0.36|Adjusted difference in mean change|-1.76||||0.09|TWO_SIDED|95.0|-3.8|0.3||a priori threshold was p\<0.05|ANCOVA|||Intent to Treat analysis with Last Observation Carried Forward.||0.3|-3.8|0.09
71147819|NCT03873116|141789739|SUPERIORITY||negative binomial regression model|-24.6||||0.181|TWO_SIDED|95.0|-50.1|14.0|||negative binomial regression model|||||14.0|-50.1|0.181
71147820|NCT03873116|141789739|SUPERIORITY||negative binomial regression model|-49.1||||0.003|TWO_SIDED|95.0|-67.5|-20.4|||negative binomial regression model|||||-20.4|-67.5|0.003
71147821|NCT03873116|141789742|SUPERIORITY||Difference in Least Square Means|0.018||||0.814|TWO_SIDED|95.0|-0.143|0.179|||ANCOVA|||Numerical differences from the placebo treatment in the LSM proportion of the 169 days of treatment with angioedema symptoms.||0.179|-0.143|0.814
71147822|NCT03873116|141789742|SUPERIORITY||Difference in Least Square Means|-0.122||||0.12|TWO_SIDED|95.0|-0.28|0.036|||ANCOVA|||Numerical differences from the placebo treatment in the LSM proportion of the 169 days of treatment with angioedema symptoms.||0.036|-0.280|0.120
71147823|NCT03873116|141789743|SUPERIORITY||mixed-model repeated measures analysis|24.5||||0.188|TWO_SIDED|95.0|-14.7|50.3|||mixed-model repeated measures analysis|||In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the second secondary endpoint of rate of expert-confirmed angioedema events during dosing in the effective treatment period for statistical significance would not be completed. Therefore, P-values reported are nominal.||50.3|-14.7|0.188
71147824|NCT03873116|141789743|SUPERIORITY||mixed-model repeated measures analysis|47.6||||0.005|TWO_SIDED|95.0|17.7|66.6|||mixed-model repeated measures analysis|||In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the second secondary endpoint of rate of expert-confirmed angioedema events during dosing in the effective treatment period for statistical significance would not be completed. Therefore, P-values reported are nominal.||66.6|17.7|0.005
71147825|NCT03873116|141789744|SUPERIORITY||mixed-model repeated measures analysis|-12.65||||0.213|TWO_SIDED|95.0|-33.33|8.03|||mixed-model repeated measures analysis|||Numerical difference in change from baseline of AE-QoL total score between treatment groups. In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the third secondary endpoint of change from baseline in AE-QoL total score at Week 24 for statistical significance would not be completed. P-values that are reported are nominal.||8.03|-33.33|0.213
71147826|NCT03873116|141789744|SUPERIORITY||mixed-model repeated measures analysis|-19.0||||0.061|TWO_SIDED|95.0|-39.0|0.99|||mixed-model repeated measures analysis|||Numerical difference in change from baseline of AE-QoL total score between treatment groups. In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the third secondary endpoint of change from baseline in AE-QoL total score at Week 24 for statistical significance would not be completed. P-values that are reported are nominal.||0.99|-39.00|0.061
71147827|NCT00912808|141789750|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||t-test, 2 sided|||Means and standard deviations were calculated to describe the subject baseline characteristics. Paired t-tests evaluated the difference between baseline and end of treatment frequency of falls. Changes post-treatment from baseline in secondary measures were also compared between the donepezil and placebo phases with paired t-tests or Wilcoxon signed rank tests when data was nonparametric. SPSS was used for the analysis.||||0.049
71147828|NCT00912808|141789751|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||t-test, 2 sided|||Means and standard deviations were calculated to describe the subject baseline characteristics. Paired t-tests evaluated the difference between baseline and end of treatment frequency of falls. Changes post-treatment from baseline in secondary measures were also compared between the donepezil and placebo phases with paired t-tests or Wilcoxon signed rank tests when data was nonparametric. SPSS was used for the analysis.||||0.27
71147829|NCT03994081|141789774|SUPERIORITY|||||||0.332|||||||t-test, 2 sided|||||||0.332
71147830|NCT03994081|141789775|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.790
71147831|NCT03994081|141789776|SUPERIORITY|||||||0.464|||||||Pearson's correlation|||||||0.464
71147832|NCT03994081|141789776|SUPERIORITY|||||||0.765|||||||Pearson's correlation|||||||0.765
71147833|NCT03994081|141789777|SUPERIORITY|||||||0.072|||||||Pearson's correlation|||||||0.072
71147834|NCT03994081|141789777|SUPERIORITY|||||||0.811|||||||Pearson's correlation|||||||0.811
71147835|NCT03955146|141789812|OTHER||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.062||0.2926|TWO_SIDED|95.0|-0.06|0.19|||Mixed Models Analysis|||||0.19|-0.06|0.2926
71147836|NCT04363320|141789821|SUPERIORITY||Slope|0.538|STANDARD_DEVIATION|0.169||0.002|TWO_SIDED|||||a prior threshold 0.05|Mixed Models Analysis||Slope is per month|Change in new patient counts (Combined MOUD) for Intervention Phase (from baseline to 12 months)||||0.002
71147837|NCT04363320|141789821|SUPERIORITY||Slope|0.38|STANDARD_DEVIATION|0.113||0.0008|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in new patient counts (Buprenorphine) for Intervention Phase (from baseline to 12 months)||||0.0008
71147838|NCT04363320|141789821|SUPERIORITY||Slope|0.207|STANDARD_DEVIATION|0.129||0.111|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in new patient counts (Methadone) for Intervention Phase (from baseline to 12 months)||||0.111
71147839|NCT04363320|141789821|SUPERIORITY||Slope|0.017|STANDARD_DEVIATION|0.014||0.235|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in new patient counts (Naltrexone) for Intervention Phase (from baseline to 12 months)||||0.235
71147840|NCT04363320|141789822|SUPERIORITY||Slope|0.153|STANDARD_DEVIATION|0.218||0.485|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month|Change in new patient counts (Combined MOUD) for Sustainability Phase (from 13 to 24 months)||||0.485
71147841|NCT04363320|141789822|SUPERIORITY||Slope|0.642|STANDARD_DEVIATION|0.19||0.0008|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in new Justice Involved Person counts (Buprenorphine) for Sustainability Phase (from 13 to 24 months)||||0.0008
71147842|NCT04363320|141789822|SUPERIORITY||Slope|-0.377|STANDARD_DEVIATION|0.154||0.015|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in new patient counts (Methadone) for Sustainability Phase (from 13 to 24 months)||||0.015
71147843|NCT04363320|141789822|SUPERIORITY||Slope|-0.02|STANDARD_DEVIATION|0.017||0.241|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in new patient counts (Naltrexone) for Sustainability Phase (from 13 to 24 months)||||0.241
71147844|NCT04363320|141789823|SUPERIORITY||Slope|1.912|STANDARD_DEVIATION|0.438||2e-05|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Combined MOUD) for Intervention Phase (from baseline to 12 months)||||0.00002
71147845|NCT04363320|141789823|SUPERIORITY||Slope|0.855|STANDARD_DEVIATION|0.206||4e-05|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Buprenorphine) for Intervention Phase (from baseline to 12 months)||||0.00004
71147846|NCT04363320|141789823|SUPERIORITY||Slope|0.322|STANDARD_DEVIATION|0.206||0.118|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Methadone) for Intervention Phase (from baseline to 12 months)||||0.118
71147847|NCT04363320|141789823|SUPERIORITY||Slope|0.073|STANDARD_DEVIATION|0.031||0.02|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Naltrexone) for Intervention Phase (from baseline to 12 months)||||0.020
71147848|NCT04363320|141789824|SUPERIORITY||Slope|0.617|STANDARD_DEVIATION|0.307||0.045|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Combined MOUD) for Sustainability Phase (from 13 to 24 months)||||0.045
71147849|NCT04363320|141789824|SUPERIORITY||Slope|1.103|STANDARD_DEVIATION|0.229||2e-06|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Buprenorphine) for Sustainability Phase (from 13 to 24 months)||||0.000002
71147850|NCT04363320|141789824|SUPERIORITY||Slope|-0.387|STANDARD_DEVIATION|0.218||0.076|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month|Change in census patient counts (Methadone) for Sustainability Phase (13 to 24 months)||||0.076
71147851|NCT04363320|141789824|SUPERIORITY||Slope|0.086|STANDARD_DEVIATION|0.036||0.019|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Naltrexone) for Sustainability Phase (from 13 to 24 months)||||0.019
71147852|NCT02628873|141789837|EQUIVALENCE|Degree of agreement between the 2 Assessors|Degree of agreement / Kappa|0.48|||<|0.01|TWO_SIDED||||||Kappa|||||||< 0.01
71147853|NCT02628873|141789838|SUPERIORITY|T-test to determine whether one method had greater reported pain|Mean Difference (Final Values)|-0.925|STANDARD_DEVIATION|2.71|<|0.3|TWO_SIDED|95.0|-2.69|1.0|||t-test, 2 sided|||||1.00|-2.69|< 0.30
71147854|NCT02628873|141789839|SUPERIORITY||Mean Difference (Final Values)|-0.431|STANDARD_DEVIATION|2.76|<|0.67|TWO_SIDED|95.0|-2.4|1.56|||t-test, 2 sided|Paired t-test (pre-procedure versus post-procedure)||||1.56|-2.40|< 0.67
71147855|NCT00541658|141789840|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.233|||||TWO_SIDED|95.0|-0.812|0.345|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.345|-0.812|
71147856|NCT00541658|141789840|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.296|||||TWO_SIDED|95.0|-0.869|0.277|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.277|-0.869|
71147857|NCT00541658|141789841|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.265||||0.2955|TWO_SIDED|95.0|-0.763|0.232|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant used.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.232|-0.763|0.2955
70875288|NCT00720434|141234806|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.36357||||0.0131|TWO_SIDED|95.0|-4.19228|-0.53485|||ANCOVA|||An analysis of covariance (ANCOVA) model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95 percentage (%) confidence interval (CI) were calculated.||-0.53485|-4.19228|0.0131
70875289|NCT00720434|141234806|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.4919||||0.0142|TWO_SIDED|95.0|-4.44619|-0.5376|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||-0.53760|-4.44619|0.0142
71147858|NCT00541658|141789842|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.131|||||TWO_SIDED|95.0|-0.674|0.412|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.412|-0.674|
71147859|NCT00541658|141789842|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|0.156|||||TWO_SIDED|95.0|-0.382|0.695|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.695|-0.382|
71147860|NCT00541658|141789843|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.258|||||TWO_SIDED|95.0|-0.836|0.321|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.321|-0.836|
71147861|NCT00541658|141789843|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.322|||||TWO_SIDED|95.0|-0.9|0.256|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.256|-0.900|
71147862|NCT00541658|141789844|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.154|||||TWO_SIDED|95.0|-1.903|-0.405|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.405|-1.903|
71147863|NCT00541658|141789844|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.044|||||TWO_SIDED|95.0|-1.789|-0.299|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.299|-1.789|
71147864|NCT00541658|141789845|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.059|||||TWO_SIDED|95.0|-1.762|-0.355|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.355|-1.762|
71147865|NCT00541658|141789845|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.922|||||TWO_SIDED|95.0|-1.62|-0.223|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.223|-1.620|
71147866|NCT00541658|141789846|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.08||||0.0524|TWO_SIDED|95.0|1.0|1.16|||Fisher Exact|||||1.16|1.00|0.0524
71147867|NCT00541658|141789846|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.07||||0.1207|TWO_SIDED|95.0|0.99|1.15|||Fisher Exact|||||1.15|0.99|0.1207
71147868|NCT00541658|141789847|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.07||||0.0729|TWO_SIDED|95.0|1.0|1.15|||Fisher Exact|||||1.15|1.00|0.0729
71147869|NCT00541658|141789847|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.06||||0.1639|TWO_SIDED|95.0|0.98|1.14|||Fisher Exact|||||1.14|0.98|0.1639
70875290|NCT00720434|141234806|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.46325||||0.1368|TWO_SIDED|95.0|-3.41898|0.49248|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||0.49248|-3.41898|0.1368
70875291|NCT00720434|141234806|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.90032||||0.3321|TWO_SIDED|95.0|-2.76711|0.96648|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||0.96648|-2.76711|0.3321
70955911|NCT00548262|141415195|SUPERIORITY_OR_OTHER||percentage of participants with success|57.1|||||TWO_SIDED|95.0|20.5|93.8|||||95% CI based on normal approximation to the binomial.|Unidentifiable: Success||93.8|20.5|
70955912|NCT00548262|141415196|SUPERIORITY_OR_OTHER||percentage of participants with success|47.6|||||TWO_SIDED|95.0|26.3|69.0|||||95% CI based on normal approximation to the binomial.|Candida albicans: Success||69.0|26.3|
70955913|NCT00548262|141415196|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Candida krusei: Success||100.0|13.3|
70955914|NCT00548262|141415196|SUPERIORITY_OR_OTHER||percentage of participants with success|70.0|||||TWO_SIDED|95.0|41.6|98.4|||||95% CI based on normal approximation to the binomial.|Candida tropicalis: Success||98.4|41.6|
70955915|NCT00548262|141415196|SUPERIORITY_OR_OTHER||percentage of participants with success|28.6|||||TWO_SIDED|95.0|0.0|62.0|||||95% CI based on normal approximation to the binomial.|Unidentifiable: Success||62.0|0.0|
70875292|NCT00720434|141234806|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.02865||||0.2839|TWO_SIDED|95.0|-2.95573|0.89844|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||0.89844|-2.95573|0.2839
70955916|NCT00548262|141415197|SUPERIORITY_OR_OTHER||percentage of participants with success|56.3|||||TWO_SIDED|95.0|39.1|73.4|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (Yes): Success||73.4|39.1|
70955917|NCT00548262|141415197|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|40.0|93.3|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (No): Success||93.3|40.0|
70955918|NCT00548262|141415197|SUPERIORITY_OR_OTHER||percentage of participants with success|54.5|||||TWO_SIDED|95.0|37.6|71.5|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (Yes): Success||71.5|37.6|
70955919|NCT00548262|141415197|SUPERIORITY_OR_OTHER||percentage of participants with success|72.7|||||TWO_SIDED|95.0|46.4|99.0|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (No): Success||99.0|46.4|
70955920|NCT00548262|141415197|SUPERIORITY_OR_OTHER||percentage of participants with success|56.4|||||TWO_SIDED|95.0|40.8|72.0|||||95% CI based on normal approximation to the binomial.|Antibiotics (Yes): Success||72.0|40.8|
70955921|NCT00548262|141415197|SUPERIORITY_OR_OTHER||percentage of participants with success|80.0|||||TWO_SIDED|95.0|44.9|100.0|||||95% CI based on normal approximation to the binomial.|Antibiotics (No): Success||100.0|44.9|
70955922|NCT00548262|141415197|SUPERIORITY_OR_OTHER||percentage of participants with success|55.3|||||TWO_SIDED|95.0|39.5|71.1|||||95% CI based on normal approximation to the binomial.|CV Catheter (Yes): Success||71.1|39.5|
70875293|NCT00720434|141234806|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12833||||0.8891|TWO_SIDED|95.0|-1.73676|1.99342|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||1.99342|-1.73676|0.8891
70875294|NCT00720434|141234807|SUPERIORITY_OR_OTHER||Difference in Proportions|0.6|||||TWO_SIDED|95.0|0.1565|0.8785||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.8785|0.1565|
70875295|NCT00720434|141234807|SUPERIORITY_OR_OTHER||Difference in Proportions|0.75|||||TWO_SIDED|95.0|0.233|0.969||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.9690|0.2330|
70875296|NCT00720434|141234807|SUPERIORITY_OR_OTHER||Difference in Proportions|0.625|||||TWO_SIDED|95.0|0.0871|0.9191||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.9191|0.0871|
70875297|NCT00720434|141234807|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.025|||||TWO_SIDED|95.0|-0.4769|0.4336||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.4336|-0.4769|
70875298|NCT00720434|141234807|SUPERIORITY_OR_OTHER||Difference in Proportions|0.125||||||95.0|-0.4024|0.6049||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6049|-0.4024|
70875299|NCT00720434|141234807|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.15|||||TWO_SIDED|95.0|-0.5729|0.3149||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.3149|-0.5729|
70955923|NCT00548262|141415197|SUPERIORITY_OR_OTHER||percentage of participants with success|83.3|||||TWO_SIDED|95.0|53.5|100.0|||||95% CI based on normal approximation to the binomial.|CV Catheter (No): Success||100.0|53.5|
70955924|NCT00548262|141415197|SUPERIORITY_OR_OTHER||percentage of participants with success|38.5|||||TWO_SIDED|95.0|12.0|64.9|||||95% CI based on normal approximation to the binomial.|TPN (Yes): Success||64.9|12.0|
70955925|NCT00548262|141415197|SUPERIORITY_OR_OTHER||percentage of participants with success|67.7|||||TWO_SIDED|95.0|51.3|84.2|||||95% CI based on normal approximation to the binomial.|TPN (No): Success||84.2|51.3|
71147870|NCT00541658|141789848|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.08||||0.0476|TWO_SIDED|95.0|1.0|1.16|||Fisher Exact|||||1.16|1.00|0.0476
70955926|NCT00548262|141415197|SUPERIORITY_OR_OTHER||percentage of participants with success|42.9|||||TWO_SIDED|95.0|6.2|79.5|||||95% CI based on normal approximation to the binomial.|Dialysis (Yes): Success||79.5|6.2|
70955927|NCT00548262|141415197|SUPERIORITY_OR_OTHER||percentage of participants with success|62.2|||||TWO_SIDED|95.0|46.5|77.8|||||95% CI based on normal approximation to the binomial.|Dialysis (No): Success||77.8|46.5|
70955928|NCT00548262|141415197|SUPERIORITY_OR_OTHER||percentage of participants with success|57.9|||||TWO_SIDED|95.0|35.7|80.1|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (Yes): Success||80.1|35.7|
71147871|NCT00541658|141789848|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.12||||0.0014|TWO_SIDED|95.0|1.04|1.2|||ANOVA|||||1.20|1.04|0.0014
70875300|NCT00720434|141234807|SUPERIORITY_OR_OTHER||Difference in Proportions|0.3|||||TWO_SIDED|95.0|-0.1836|0.6931||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6931|-0.1836|
70875301|NCT00720434|141234807|SUPERIORITY_OR_OTHER||Difference in Proportions|0.375|||||TWO_SIDED|95.0|-0.1732|0.7797||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.7797|-0.1732|
70955929|NCT00548262|141415197|SUPERIORITY_OR_OTHER||percentage of participants with success|60.0|||||TWO_SIDED|95.0|40.8|79.2|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (No): Success||79.2|40.8|
70955930|NCT00548262|141415197|SUPERIORITY_OR_OTHER||percentage of participants with success|59.1|||||TWO_SIDED|95.0|44.6|73.6|||||95% CI based on normal approximation to the binomial.|Solid organ transplant (No): Success||73.6|44.6|
70955931|NCT00548262|141415197|SUPERIORITY_OR_OTHER||percentage of participants with success|42.9|||||TWO_SIDED|95.0|6.2|79.5|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (Yes): Success||79.5|6.2|
70955932|NCT00548262|141415197|SUPERIORITY_OR_OTHER||percentage of participants with success|62.2|||||TWO_SIDED|95.0|46.5|77.8|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (No): Success||77.8|46.5|
70955933|NCT00548262|141415197|SUPERIORITY_OR_OTHER||percentage of participants with success|58.1|||||TWO_SIDED|95.0|43.4|72.9|||||95% CI based on normal approximation to the binomial.|Chemotherapy (No): Success||72.9|43.4|
70875302|NCT00720434|141234807|SUPERIORITY_OR_OTHER||Difference in Proportions|0.125|||||TWO_SIDED|95.0|-0.4024|0.6049||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6049|-0.4024|
70875303|NCT00720434|141234807|SUPERIORITY_OR_OTHER||Difference in Proportions|0.175|||||TWO_SIDED|95.0|-0.2934|0.5917||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5917|-0.2934|
70955934|NCT00548262|141415197|SUPERIORITY_OR_OTHER||percentage of participants with success|20.0|||||TWO_SIDED|95.0|0.0|55.1|||||95% CI based on normal approximation to the binomial.|Pancreatitis (Yes): Success||55.1|0.0|
70955935|NCT00548262|141415197|SUPERIORITY_OR_OTHER||percentage of participants with success|64.1|||||TWO_SIDED|95.0|49.0|79.2|||||95% CI based on normal approximation to the binomial.|Pancreatitis (No): Success||79.2|49.0|
70955936|NCT00548262|141415197|SUPERIORITY_OR_OTHER||percentage of participants with success|50.0|||||TWO_SIDED|95.0|21.7|78.3|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (Yes): Success||78.3|21.7|
70955937|NCT00548262|141415197|SUPERIORITY_OR_OTHER||percentage of participants with success|62.5|||||TWO_SIDED|95.0|45.7|79.3|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (No): Success||79.3|45.7|
70955938|NCT00548262|141415197|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Neutropenic: Success||100.0|13.3|
70955939|NCT00548262|141415197|SUPERIORITY_OR_OTHER||percentage of participants with success|62.1|||||TWO_SIDED|95.0|44.4|79.7|||||95% CI based on normal approximation to the binomial.|Non-neutropenic: Success||79.7|44.4|
70955940|NCT00548262|141415198|SUPERIORITY_OR_OTHER||percentage of participants with success|56.3|||||TWO_SIDED|95.0|39.1|73.4|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (Yes): Success||73.4|39.1|
70955941|NCT00548262|141415198|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|40.0|93.3|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (No): Success||93.3|40.0|
71147872|NCT00541658|141789849|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.08||||0.0547|TWO_SIDED|95.0|1.0|1.16|||ANOVA|||||1.16|1.00|0.0547
70955942|NCT00548262|141415198|SUPERIORITY_OR_OTHER||percentage of participants with success|54.5|||||TWO_SIDED|95.0|37.6|71.5|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (Yes): Success||71.5|37.6|
70955943|NCT00548262|141415198|SUPERIORITY_OR_OTHER||percentage of participants with success|72.7|||||TWO_SIDED|95.0|46.4|99.0|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (No): Success||99.0|46.4|
70955944|NCT00548262|141415198|SUPERIORITY_OR_OTHER||percentage of participants with success|56.4|||||TWO_SIDED|95.0|40.8|72.0|||||95% CI based on normal approximation to the binomial.|Antibiotics (Yes): Success||72.0|40.8|
70955945|NCT00548262|141415198|SUPERIORITY_OR_OTHER||percentage of participants with success|80.0|||||TWO_SIDED|95.0|44.9|100.0|||||95% CI based on normal approximation to the binomial.|Antibiotics (No): Success||100.0|44.9|
70955946|NCT00548262|141415198|SUPERIORITY_OR_OTHER||percentage of participants with success|55.3|||||TWO_SIDED|95.0|39.5|71.1|||||95% CI based on normal approximation to the binomial.|CV Catheter (Yes): Success||71.1|39.5|
70955947|NCT00548262|141415198|SUPERIORITY_OR_OTHER||percentage of participants with success|83.3|||||TWO_SIDED|95.0|53.5|100.0|||||95% CI based on normal approximation to the binomial.|CV Catheter (No): Success||100.0|53.5|
70955948|NCT00548262|141415198|SUPERIORITY_OR_OTHER||percentage of participants with success|46.2|||||TWO_SIDED|95.0|19.1|73.3|||||95% CI based on normal approximation to the binomial.|TPN (Yes): Success||73.3|19.1|
70955949|NCT00548262|141415198|SUPERIORITY_OR_OTHER||percentage of participants with success|64.5|||||TWO_SIDED|95.0|47.7|81.4|||||95% CI based on normal approximation to the binomial.|TPN (No): Success||81.4|47.7|
70955950|NCT00548262|141415198|SUPERIORITY_OR_OTHER||percentage of participants with success|42.9|||||TWO_SIDED|95.0|6.2|79.5|||||95% CI based on normal approximation to the binomial.|Dialysis (Yes): Success||79.5|6.2|
71147873|NCT00541658|141789849|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.1||||0.0066|TWO_SIDED|95.0|1.03|1.18|||ANOVA|||||1.18|1.03|0.0066
70955951|NCT00548262|141415198|SUPERIORITY_OR_OTHER||percentage of participants with success|62.2|||||TWO_SIDED|95.0|46.5|77.8|||||95% CI based on normal approximation to the binomial.|Dialysis (No): Success||77.8|46.5|
70955952|NCT00548262|141415198|SUPERIORITY_OR_OTHER||percentage of participants with success|63.2|||||TWO_SIDED|95.0|41.5|84.8|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (Yes): Success||84.8|41.5|
70955953|NCT00548262|141415198|SUPERIORITY_OR_OTHER||percentage of participants with success|56.0|||||TWO_SIDED|95.0|36.5|75.5|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (No): Success||75.5|36.5|
70955954|NCT00548262|141415198|SUPERIORITY_OR_OTHER||percentage of participants with success|59.1|||||TWO_SIDED|95.0|44.6|73.6|||||95% CI based on normal approximation to the binomial.|Solid organ transplant (No): Success||73.6|44.6|
70955955|NCT00548262|141415198|SUPERIORITY_OR_OTHER||percentage of participants with success|42.9|||||TWO_SIDED|95.0|6.2|79.5|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (Yes): Success||79.5|6.2|
70955956|NCT00548262|141415198|SUPERIORITY_OR_OTHER||percentage of participants with success|62.2|||||TWO_SIDED|95.0|46.5|77.8|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (No): Success||77.8|46.5|
70955957|NCT00548262|141415198|SUPERIORITY_OR_OTHER||percentage of participants with success|58.1|||||TWO_SIDED|95.0|43.4|72.9|||||95% CI based on normal approximation to the binomial.|Chemotherapy (No): Success||72.9|43.4|
70955958|NCT00548262|141415198|SUPERIORITY_OR_OTHER||percentage of participants with success|40.0|||||TWO_SIDED|95.0|0.0|82.9|||||95% CI based on normal approximation to the binomial.|Pancreatitis (Yes): Success||82.9|0.0|
70955959|NCT00548262|141415198|SUPERIORITY_OR_OTHER||percentage of participants with success|61.5|||||TWO_SIDED|95.0|46.3|76.8|||||95% CI based on normal approximation to the binomial.|Pancreatitis (No): Success||76.8|46.3|
70875304|NCT00720434|141234807|SUPERIORITY_OR_OTHER||Difference in Proportions|0.25|||||TWO_SIDED|95.0|-0.2913|0.696||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6960|-0.2913|
70875305|NCT00720434|141234807|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.075|||||TWO_SIDED|95.0|-0.5144|0.388||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.3880|-0.5144|
70875306|NCT00720434|141234807|SUPERIORITY_OR_OTHER||Difference in Proportions|0.1|||||TWO_SIDED|95.0|-0.3728|0.5414||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5414|-0.3728|
70875307|NCT00720434|141234807|SUPERIORITY_OR_OTHER||Difference in Proportions|0.25|||||TWO_SIDED|95.0|-0.2913|0.696||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6960|-0.2913|
70875308|NCT00720434|141234807|SUPERIORITY_OR_OTHER||Difference in Proportions|0.125|||||TWO_SIDED|95.0|-0.4024|0.6049||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6049|-0.4024|
70875309|NCT00720434|141234807|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.025||||||95.0|-0.4769|0.4336||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.4336|-0.4769|
70875310|NCT00720434|141234807|SUPERIORITY_OR_OTHER||Difference in Proportions|0.125|||||TWO_SIDED|95.0|-0.4024|0.6049||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6049|-0.4024|
70875311|NCT00720434|141234807|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.15|||||TWO_SIDED|95.0|-0.5729|0.3149||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.3149|-0.5729|
70875312|NCT00720434|141234807|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.2|||||TWO_SIDED|95.0|-0.6191|0.2811||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.2811|-0.6191|
70875313|NCT00720434|141234807|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0|||||TWO_SIDED|95.0|-0.507|0.507||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5070|-0.5070|
70875314|NCT00720434|141234807|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0|||||TWO_SIDED|95.0|-0.507|0.507||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5070|-0.5070|
70875315|NCT00720434|141234807|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.2|||||TWO_SIDED|95.0|-0.6191|0.2811||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.2811|-0.6191|
70875316|NCT00720434|141234807|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0|||||TWO_SIDED|95.0|-0.507|0.507||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5070|-0.5070|
70875317|NCT00720434|141234807|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.2|||||TWO_SIDED|95.0|-0.6191|0.2811||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.2811|-0.6191|
70875318|NCT00720434|141234807|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.2|||||TWO_SIDED|95.0|-0.6191|0.2811||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.2811|-0.6191|
70875319|NCT00720434|141234807|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0|||||TWO_SIDED|95.0|-0.507|0.507||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5070|-0.5070|
70875320|NCT00720434|141234807|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0|||||TWO_SIDED|95.0|-0.507|0.507||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5070|-0.5070|
70875321|NCT00720434|141234807|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.2|||||TWO_SIDED|95.0|-0.6191|0.2811||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.2811|-0.6191|
70875322|NCT00720434|141234807|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0|||||TWO_SIDED|95.0|-0.507|0.507||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5070|-0.5070|
70875323|NCT00720434|141234807|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.2|||||TWO_SIDED|95.0|-0.6191|0.2811||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.2811|-0.6191|
70875324|NCT00720434|141234810|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.36357||||0.0131|TWO_SIDED|95.0|-4.19228|-0.53485|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||-0.53485|-4.19228|0.0131
70875325|NCT00720434|141234810|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.4919||||0.0142|TWO_SIDED|95.0|-4.44619|-0.5376|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||-0.53760|-4.44619|0.0142
70875326|NCT00720434|141234810|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.46325||||0.1368|TWO_SIDED|95.0|-3.41898|0.49248|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||0.49248|-3.41898|0.1368
70875327|NCT00720434|141234810|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.90032||||0.3321|TWO_SIDED|95.0|-2.76711|0.96648|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||0.96648|-2.76711|0.3321
70875328|NCT00720434|141234810|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.02865||||0.2839|TWO_SIDED|95.0|-2.95573|0.89844|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||0.89844|-2.95573|0.2839
70875329|NCT00720434|141234810|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12833||||0.8891|TWO_SIDED|95.0|-1.73676|1.99342|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||1.99342|-1.73676|0.8891
70875330|NCT02057406|141234811|SUPERIORITY|The EPA/DHA arm versus placebo at Week 12.||||||0.74|||||||ANCOVA|||The model used post-treatment HAMD values as the dependent variable and included age, race, sex, treatment site, and the baseline HAMD value as covariates. This analysis was conducted under intention-to-treat (ITT) in which the missing HAMD endpoint values were imputed using 50 imputations.||||0.74
70875331|NCT02057406|141234811|SUPERIORITY|High EPA group versus placebo group at Week 12.||||||0.45|||||||ANCOVA|||The model used post-treatment HAMD values as the dependent variable and included age, race, sex, treatment site, and the baseline HAMD value as covariates. This analysis was conducted under intention-to-treat (ITT) in which the missing HAMD endpoint values were imputed using 50 imputations.||||0.45
70875332|NCT02057406|141234812|SUPERIORITY|Active supplements (2:1 EPA/DHA and High EPA combined) versus placebo at Week 12.|||||<|0.0001|||||||ANCOVA|||The model used post-treatment EPA values as the dependent variable and included age, race, sex, treatment site, and the baseline EPA value as covariates. This analyses was conducted under intention-to-treat (ITT) in which the missing EPA endpoint values were imputed using 50 imputations.||||<0.0001
70875333|NCT02057406|141234812|SUPERIORITY|2:1 EPA/DHA versus High EPA at Week 12.||||||0.12|||||||ANCOVA|||The model used post-treatment EPA values as the dependent variable and included age, race, sex, treatment site, and the baseline EPA value as covariates. This analyses was conducted under intention-to-treat (ITT) in which the missing EPA endpoint values were imputed using 50 imputations.||||0.12
70875334|NCT01571427|141234813|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.35||0.25|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.25
70875335|NCT01571427|141234813|EQUIVALENCE|Power calculation was based on the entire sample (CDR=0 and CDR=0.5 combined). Analyses within each CDR group are exploratory.|Median Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.42||0.25|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: AMONG CDR=0 group (N=49)||||0.25
70875336|NCT01571427|141234813|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses within each CDR group are exploratory.|Median Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.62||0.85|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analyses 3: AMONG CDR=0.5 (Mild Cognitive Impairment) group, N=34 .||||0.85
70955960|NCT00548262|141415198|SUPERIORITY_OR_OTHER||percentage of participants with success|58.3|||||TWO_SIDED|95.0|30.4|86.2|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (Yes): Success||86.2|30.4|
70955961|NCT00548262|141415198|SUPERIORITY_OR_OTHER||percentage of participants with success|59.4|||||TWO_SIDED|95.0|42.4|76.4|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (No): Success||76.4|42.4|
71147874|NCT00541658|141789850|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.135|||||TWO_SIDED|95.0|-0.504|0.234|||ANOVA|Fixed effect for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.234|-0.504|
70875337|NCT01571427|141234814|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|0.92||0.02|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.02
70875338|NCT01571427|141234814|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|1.28||0.003|TWO_SIDED|||||Statistically significant based on the Bonferroni multiple comparison adjusted P value of P\<0.004.|Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: AMONG CDR=0 group (N=49)||||0.003
70875339|NCT01571427|141234814|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|1.14||0.65|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analyses 3: CDR=0.5 (Mild Cognitive Impairment) group, N=34||||0.65
70875340|NCT01571427|141234815|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|1.33||0.98|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.98
70875341|NCT01571427|141234815|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|1.63||0.96|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: Among CDR 0 (n=49)||||0.96
70875342|NCT01571427|141234815|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|2.38||0.83|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: Among CDR 0.5 (n=34)||||0.83
70955962|NCT00548262|141415198|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Neutropenic: Success||100.0|13.3|
71147875|NCT00541658|141789850|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.072|||||TWO_SIDED|95.0|-0.437|0.294|||ANOVA|Fixed effect for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.294|-0.437|
71147876|NCT00541658|141789851|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.321|||||TWO_SIDED|95.0|-0.724|0.082|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.082|-0.724|
71147877|NCT00541658|141789851|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.29|||||TWO_SIDED|95.0|-0.692|0.112|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.112|-0.692|
71147878|NCT00541658|141789852|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.288|||||TWO_SIDED|95.0|-0.682|0.106|||ANOVA|Fixed effect for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.106|-0.682|
71147879|NCT00541658|141789852|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.29|||||TWO_SIDED|95.0|-0.681|0.101|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.101|-0.681|
71147880|NCT00541658|141789853|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.644|||||TWO_SIDED|95.0|-1.179|-0.11|||ANOVA|||||-0.110|-1.179|
71147881|NCT00541658|141789853|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.587|||||TWO_SIDED|95.0|-1.116|-0.059|||ANOVA|||||-0.059|-1.116|
71147882|NCT00541658|141789854|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.522|||||TWO_SIDED|95.0|-1.03|-0.014|||ANOVA|||||-0.014|-1.030|
71147883|NCT00541658|141789854|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.468|||||TWO_SIDED|95.0|-0.973|0.037|||ANOVA|||||0.037|-0.973|
71147884|NCT00541658|141789855|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.265|||||TWO_SIDED|95.0|-0.731|0.201|||ANOVA|Fixed effects for treatment, pooled centers and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.201|-0.731|
71147885|NCT00541658|141789855|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.126|||||TWO_SIDED|95.0|-0.588|0.336|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.336|-0.588|
71147886|NCT00541658|141789856|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.328|||||TWO_SIDED|95.0|-0.811|0.156|||ANOVA|Fixed effects for treatment, pooled centers and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.156|-0.811|
71147887|NCT00541658|141789856|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.563|||||TWO_SIDED|95.0|-1.045|-0.08|||ANOVA|Fixed effects for treatment, pooled center, anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.080|-1.045|
71147888|NCT00541658|141789857|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.327|||||TWO_SIDED|95.0|-0.793|0.138|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.138|-0.793|
71147889|NCT00541658|141789857|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.537|||||TWO_SIDED|95.0|-1.0|-0.074|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.074|-1.000|
71147890|NCT00541658|141789858|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.578|||||TWO_SIDED|95.0|-1.189|0.032|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.032|-1.189|
70875343|NCT01571427|141234816|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.64||0.68|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.68
70875344|NCT01571427|141234816|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.84||0.69|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.69
70875345|NCT01571427|141234816|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|1.02||0.86|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.86
70875346|NCT01571427|141234817|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.43||0.92|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.92
70875347|NCT01571427|141234817|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.61||0.92|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.92
70875348|NCT01571427|141234817|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.62||0.94|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.94
70955963|NCT00548262|141415198|SUPERIORITY_OR_OTHER||percentage of participants with success|62.1|||||TWO_SIDED|95.0|44.4|79.7|||||95% CI based on normal approximation to the binomial.|Non-neutropenic: Success||79.7|44.4|
71147891|NCT00541658|141789858|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.799|||||TWO_SIDED|95.0|-1.403|-0.194|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.194|-1.403|
71147892|NCT00541658|141789859|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.555|||||TWO_SIDED|95.0|-1.128|0.018|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.018|-1.128|
71147893|NCT00541658|141789859|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.616|||||TWO_SIDED|95.0|-1.185|-0.046|||ANOVA|Fixed effect for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.046|-1.185|
71147894|NCT00541658|141789860|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.249|||||TWO_SIDED|95.0|-0.86|0.363|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.363|-0.860|
71147895|NCT00541658|141789860|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.265|||||TWO_SIDED|95.0|-0.871|0.342|||ANOVA|Fixed effect for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.342|-0.871|
71147896|NCT00541658|141789861|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.557|||||TWO_SIDED|95.0|-1.185|0.071|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.071|-1.185|
71147897|NCT00541658|141789861|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.522|||||TWO_SIDED|95.0|-1.149|0.105|||ANOVA||LS Mean Difference is 5 mg daily minus weekly treatment.|||0.105|-1.149|
70955964|NCT00548262|141415199|SUPERIORITY_OR_OTHER||percentage of participants with success|37.5|||||TWO_SIDED|95.0|20.7|54.3|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (Yes): Success||54.3|20.7|
70955965|NCT00548262|141415199|SUPERIORITY_OR_OTHER||percentage of participants with success|75.0|||||TWO_SIDED|95.0|50.5|99.5|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (No): Success||99.5|50.5|
70955966|NCT00548262|141415199|SUPERIORITY_OR_OTHER||percentage of participants with success|39.4|||||TWO_SIDED|95.0|22.7|56.1|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (Yes): Success||56.1|22.7|
71147898|NCT00541658|141789862|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.546|||||TWO_SIDED|95.0|-1.17|0.078|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.078|-1.170|
71147899|NCT00541658|141789862|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.579|||||TWO_SIDED|95.0|-1.199|0.042|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.042|-1.199|
71147900|NCT00541658|141789863|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.095|||||TWO_SIDED|95.0|-1.861|-0.329|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.329|-1.861|
71147901|NCT00541658|141789863|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.19|||||TWO_SIDED|95.0|-1.948|-0.432|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.432|-1.948|
71147902|NCT00541658|141789864|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.919|||||TWO_SIDED|95.0|-1.655|-0.184|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.184|-1.655|
70875349|NCT01571427|141234818|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-2.11|STANDARD_ERROR_OF_MEAN|2.84||0.46|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.46
70875350|NCT01571427|141234818|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|2.08||0.61|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.61
70875351|NCT01571427|141234818|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-1.66|STANDARD_ERROR_OF_MEAN|6.42||0.8|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.80
70955967|NCT00548262|141415199|SUPERIORITY_OR_OTHER||percentage of participants with success|72.7|||||TWO_SIDED|95.0|46.4|99.0|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (No): Success||99.0|46.4|
71147903|NCT00541658|141789864|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.056|||||TWO_SIDED|95.0|-1.787|-0.326|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.326|-1.787|
71147904|NCT00541658|141789865|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|3.771|||||TWO_SIDED|95.0|-0.885|8.427|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||8.427|-0.885|
71147905|NCT00541658|141789865|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|2.826|||||TWO_SIDED|95.0|-1.819|7.471|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||7.471|-1.819|
71147906|NCT00541658|141789866|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|2.63|||||TWO_SIDED|95.0|-2.171|7.431|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||7.431|-2.171|
71147907|NCT00541658|141789866|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.617|||||TWO_SIDED|95.0|-0.152|9.386|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.386|-0.152|
71147908|NCT00541658|141789867|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|5.04|||||TWO_SIDED|95.0|0.091|9.989|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.989|0.091|
71147909|NCT00541658|141789867|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.64|||||TWO_SIDED|95.0|-0.293|9.574|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.574|-0.293|
71147910|NCT00541658|141789868|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|6.372|||||TWO_SIDED|95.0|1.329|11.414|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||11.414|1.329|
71147911|NCT00541658|141789868|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.403|||||TWO_SIDED|95.0|-0.619|9.425|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.425|-0.619|
71147912|NCT00541658|141789869|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|4.739|||||TWO_SIDED|95.0|-0.793|10.271|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||10.271|-0.793|
71147913|NCT00541658|141789869|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|3.999|||||TWO_SIDED|95.0|-1.518|9.515|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.515|-1.518|
70875352|NCT01571427|141234819|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|3.25|STANDARD_ERROR_OF_MEAN|8.88||0.72|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.72
70875353|NCT01571427|141234819|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|2.26|STANDARD_ERROR_OF_MEAN|11.1||0.84|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.84
70875354|NCT01571427|141234819|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|12.39|STANDARD_ERROR_OF_MEAN|14.4||0.4|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.40
70955968|NCT00548262|141415199|SUPERIORITY_OR_OTHER||percentage of participants with success|48.7|||||TWO_SIDED|95.0|33.0|64.4|||||95% CI based on normal approximation to the binomial.|Antibiotics (Yes): Success||64.4|33.0|
70955969|NCT00548262|141415199|SUPERIORITY_OR_OTHER||percentage of participants with success|40.0|||||TWO_SIDED|95.0|0.0|82.9|||||95% CI based on normal approximation to the binomial.|Antibiotics (No): Success||82.9|0.0|
71147914|NCT00541658|141789870|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|4.817|||||TWO_SIDED|95.0|-0.693|10.327|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||10.327|-0.693|
71147915|NCT00541658|141789870|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|3.192|||||TWO_SIDED|95.0|-2.295|8.68|||ANOVA|Fixed effects for treatment, pooled centers and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||8.680|-2.295|
70955970|NCT00548262|141415199|SUPERIORITY_OR_OTHER||percentage of participants with success|47.4|||||TWO_SIDED|95.0|31.5|63.2|||||95% CI based on normal approximation to the binomial.|CV Catheter (Yes): Success||63.2|31.5|
71147916|NCT00541658|141789871|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.45|||||TWO_SIDED|95.0|-0.26|9.16|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.160|-0.260|
71147917|NCT00541658|141789871|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|3.723|||||TWO_SIDED|95.0|-0.975|8.421|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||8.421|-0.975|
71147918|NCT00541658|141789872|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.798|||||TWO_SIDED|95.0|-0.195|9.79|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.790|-0.195|
71147919|NCT00541658|141789872|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.972|||||TWO_SIDED|95.0|0.02|9.924|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.924|0.020|
71147920|NCT00541658|141789873|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.775|||||TWO_SIDED|95.0|-0.514|10.065|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||10.065|-0.514|
70955971|NCT00548262|141415199|SUPERIORITY_OR_OTHER||percentage of participants with success|50.0|||||TWO_SIDED|95.0|10.0|90.0|||||95% CI based on normal approximation to the binomial.|CV Catheter (No): Success||90.0|10.0|
71147921|NCT00541658|141789873|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|5.638||||||95.0|0.356|10.92|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||10.920|0.356|
71147922|NCT00541658|141789874|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|6.552|||||TWO_SIDED|95.0|1.162|11.942|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||11.942|1.162|
71147923|NCT00541658|141789874|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|5.531|||||TWO_SIDED|95.0|0.164|10.897|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||10.897|0.164|
71147924|NCT00541658|141789875|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|7.83|||||TWO_SIDED|95.0|1.175|14.485|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||14.485|1.175|
71147925|NCT00541658|141789875|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|8.383|||||TWO_SIDED|95.0|1.757|15.01|||ANOVA|Fixed effects for treatment, pooled centers and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||15.010|1.757|
71147926|NCT00541658|141789876|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|7.802|||||TWO_SIDED|95.0|1.385|14.22|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||14.220|1.385|
71147927|NCT00541658|141789876|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|7.301|||||TWO_SIDED|95.0|0.911|13.69|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||13.690|0.911|
71147928|NCT00541658|141789877|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.755|||||TWO_SIDED|95.0|-1.145|4.655|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.655|-1.145|
71147929|NCT00541658|141789877|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.805|||||TWO_SIDED|95.0|-1.087|4.698|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.698|-1.087|
71147930|NCT00541658|141789878|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|2.407|||||TWO_SIDED|95.0|-0.502|5.316|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||5.316|-0.502|
70875355|NCT01571427|141234820|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.91||0.38|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.38
70875356|NCT01571427|141234820|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|1.31||0.39|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.39
70875357|NCT01571427|141234820|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|1.26||0.59|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.59
70875358|NCT01571427|141234821|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.02||0.03|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.03
70875359|NCT01571427|141234821|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.24|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.24
70875360|NCT01571427|141234821|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.04||0.04|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.04
70875361|NCT01571427|141234822|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.65|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.65
70875362|NCT01571427|141234822|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.64|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.64
70875363|NCT01571427|141234822|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.1||0.42|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.42
70875364|NCT01571427|141234823|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.45||0.45|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.45
70875365|NCT01571427|141234823|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.05||0.93|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.93
70875366|NCT01571427|141234823|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.08||0.4|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.40
70955972|NCT00548262|141415199|SUPERIORITY_OR_OTHER||percentage of participants with success|38.5|||||TWO_SIDED|95.0|12.0|64.9|||||95% CI based on normal approximation to the binomial.|TPN (Yes): Success||64.9|12.0|
70875367|NCT01571427|141234824|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.09||0.3|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.30
70875368|NCT01571427|141234824|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.1||0.75|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.75
70875369|NCT01571427|141234824|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.15||0.12|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.12
70875370|NCT03395886|141234829|OTHER|||||||0.831|||||||Chi-squared|||Summary statistics are expressed as numbers and percentages and compared between groups by Chi-square test.||||0.831
70875371|NCT03395886|141234830|OTHER|||||||0.8|||||||Generalized estimating equations|||||||0.800
70875372|NCT03247530|141234835|SUPERIORITY||Least Square Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|1.61||0.0004|TWO_SIDED|95.0|-8.9|-2.6|||Mixed Models for Repeated Measures|||||-2.6|-8.9|0.0004
70875373|NCT03247530|141234835|SUPERIORITY||Least Square Mean Difference|-6.9|STANDARD_ERROR_OF_MEAN|1.58|<|0.0001|TWO_SIDED|95.0|-10.0|-3.8|||Mixed Models for Repeated Measures|||||-3.8|-10.0|<0.0001
70875374|NCT03247530|141234836|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.002|TWO_SIDED|95.0|-0.7|-0.2|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.2|-0.7|0.0020
70875375|NCT03247530|141234836|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.8|-0.3|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.3|-0.8|<0.0001
70875376|NCT03247530|141234837|SUPERIORITY||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|1.16||0.0003|TWO_SIDED|95.0|-6.5|-1.9|||ANCOVA|||||-1.9|-6.5|0.0003
70875377|NCT03247530|141234837|SUPERIORITY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|1.15||0.0002|TWO_SIDED|95.0|-6.6|-2.1|||ANCOVA|||||-2.1|-6.6|0.0002
70875378|NCT03247530|141234838|SUPERIORITY||Least Square Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.047||0.0019|TWO_SIDED|95.0|-0.24|-0.05|||ANCOVA|||||-0.05|-0.24|0.0019
70875379|NCT03247530|141234838|SUPERIORITY||Least Square Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.046||0.002|TWO_SIDED|95.0|-0.26|-0.08|||ANCOVA|||||-0.08|-0.26|0.0020
70875380|NCT03247530|141234839|SUPERIORITY||Risk Difference (RD)|14.5||||0.0063|TWO_SIDED|95.0|4.3|24.6|||Regression, Logistic|||||24.6|4.3|0.0063
70875381|NCT03247530|141234839|SUPERIORITY||Risk Difference (RD)|21.5|||<|0.0001|TWO_SIDED|95.0|11.3|31.6|||Regression, Logistic|||||31.6|11.3|<0.0001
70875382|NCT03247530|141234840|SUPERIORITY||Least Square Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.63||0.9974|TWO_SIDED|95.0|-4.5|4.5|||ANCOVA|||||4.5|-4.5|0.9974
70875383|NCT03247530|141234840|SUPERIORITY||Least Square Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|2.26||0.4557|TWO_SIDED|95.0|-6.1|2.7|||ANCOVA|||||2.7|-6.1|0.4557
70875384|NCT03247530|141234841|SUPERIORITY||Least Square Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.85||0.0006|TWO_SIDED|95.0|-4.6|-1.2|||ANCOVA|||This statistical analysis pertains to the Inattention subscale score||-1.2|-4.6|0.0006
70875385|NCT03247530|141234841|SUPERIORITY||Least Square Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|0.83|<|0.0001|TWO_SIDED|95.0|-5.2|-1.9|||ANCOVA|||This statistical analysis pertains to the Inattention subscale score||-1.9|-5.2|<0.0001
70875386|NCT03247530|141234841|SUPERIORITY||Least Square Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.83||0.0026|TWO_SIDED|95.0|-4.1|-0.9|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-0.9|-4.1|0.0026
70875387|NCT03247530|141234841|SUPERIORITY||Least Square Mean Difference|-3.2|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-4.8|-1.7|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-1.7|-4.8|<0.0001
70875388|NCT03247530|141234842|SUPERIORITY||Least Square Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|1.2||0.1292|TWO_SIDED|95.0|-4.2|0.5|||ANCOVA|||||0.5|-4.2|0.1292
70875389|NCT03247530|141234842|SUPERIORITY||Least Square Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|1.19||0.3447|TWO_SIDED|95.0|-3.4|1.2|||ANCOVA|||||1.2|-3.4|0.3447
70875390|NCT03247530|141234843|SUPERIORITY|||||||0.0005|||||||Chi-squared|||This analysis pertains to Week 1 of treatment||||0.0005
70875391|NCT03247530|141234843|SUPERIORITY|||||||0.0212|||||||Chi-squared|||This analysis pertains to Week 2 of treatment||||0.0212
70875392|NCT03247530|141234843|SUPERIORITY|||||||0.0115|||||||Chi-squared|||This analysis pertains to Week 3 of treatment||||0.0115
70875393|NCT03247530|141234843|SUPERIORITY|||||||0.0027|||||||Chi-squared|||This analysis pertains to Week 4 of treatment||||0.0027
70875394|NCT03247530|141234843|SUPERIORITY|||||||0.0066|||||||Chi-squared|||This analysis pertains to Week 5 of treatment||||0.0066
70875395|NCT03247530|141234843|SUPERIORITY|||||||0.0065|||||||Chi-squared|||This analysis pertains to Week 6 of treatment||||0.0065
70875396|NCT03247530|141234843|SUPERIORITY|||||||0.5826|||||||Chi-squared|||This analysis pertains to Week 1 of treatment||||0.5826
70875397|NCT03247530|141234843|SUPERIORITY|||||||0.0099|||||||Chi-squared|||This analysis pertains to Week 2 of treatment||||0.0099
70875398|NCT03247530|141234843|SUPERIORITY|||||||0.0225|||||||Chi-squared|||This analysis pertains to Week 3 of treatment||||0.0225
70875399|NCT03247530|141234843|SUPERIORITY|||||||0.0008|||||||Chi-squared|||This analysis pertains to Week 4 of treatment||||0.0008
70875400|NCT03247530|141234843|SUPERIORITY|||||||0.002|||||||Chi-squared|||This analysis pertains to Week 5 of treatment||||0.0020
70875401|NCT03247530|141234843|SUPERIORITY|||||||0.0002|||||||Chi-squared|||This analysis pertains to Week 6 of treatment||||0.0002
70875402|NCT02533427|141234844|OTHER||% Geometric Least Square Mean(GLSM)Ratio|107.36|||||TWO_SIDED|90.0|103.19|111.69|||||Test/Reference: Norelgestromin Part B/Part A|Norelgestromin Part B/Part A||111.69|103.19|
70875403|NCT02533427|141234845|OTHER||% GLSM Ratio|115.14|||||TWO_SIDED|90.0|106.49|124.5|||||Test/Reference: Norgestrel Part B/Part A|Norgestrel Part B/Part A||124.50|106.49|
70875404|NCT02533427|141234846|OTHER||% GLSM Ratio|105.43|||||TWO_SIDED|90.0|96.95|114.66|||||Test/Reference: Ethinyl estradiol Part B/Part A|Ethinyl estradiol Part B/Part A||114.66|96.95|
70875405|NCT02533427|141234847|OTHER||% GLSM Ratio|248.89|||||TWO_SIDED|90.0|33.11|1870.81|||||Test/Reference: Norgestimate Part B/Part A|Norgestimate Part B/Part A||1870.81|33.11|
70875406|NCT02533427|141234848|OTHER||% GLSM Ratio|107.71|||||TWO_SIDED|90.0|97.78|118.65|||||Test/Reference: Norelgestromin Part B/Part A|Norelgestromin Part B/Part A||118.65|97.78|
71147931|NCT00541658|141789878|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.309|||||TWO_SIDED|95.0|-1.576|4.194|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.194|-1.576|
71147932|NCT00541658|141789879|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.555|||||TWO_SIDED|95.0|-1.617|4.727|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.727|-1.617|
71147933|NCT00541658|141789879|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.612|||||TWO_SIDED|95.0|-1.556|4.779|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.779|-1.556|
71147934|NCT00541658|141789880|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.434|||||TWO_SIDED|95.0|-1.652|4.521|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.521|-1.652|
71147935|NCT00541658|141789880|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.462|||||TWO_SIDED|95.0|-1.611|4.535|||ANOVA|Fixed effect for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.535|-1.611|
71147936|NCT00541658|141789881|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|2.749|||||TWO_SIDED|95.0|-0.938|6.436|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||6.436|-0.938|
71147937|NCT00541658|141789881|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|3.416|||||TWO_SIDED|95.0|-0.255|7.087|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus daily treatment.|||7.087|-0.255|
71147938|NCT00541658|141789882|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|2.197|||||TWO_SIDED|95.0|-1.318|5.711|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||5.711|-1.318|
71147939|NCT00541658|141789882|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|2.251|||||TWO_SIDED|95.0|-1.248|5.751|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||5.751|-1.248|
71147940|NCT00541658|141789883|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.0||||1|TWO_SIDED|95.0|0.14|7.05|||Fisher Exact|||||7.05|0.14|1.0000
71147941|NCT00541658|141789883|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.5||||1|TWO_SIDED|95.0|0.25|8.9|||Fisher Exact|||||8.90|0.25|1.0000
71147942|NCT00541658|141789884|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.03||||1|TWO_SIDED|95.0|0.15|7.29|||Fisher Exact|||||7.29|0.15|1.0000
71147943|NCT00541658|141789884|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.49||||1|TWO_SIDED|95.0|0.25|8.87|||Fisher Exact|||||8.87|0.25|1.0000
71147944|NCT00541658|141789885|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.42||||0.4505|TWO_SIDED|95.0|0.08|2.14|||Fisher Exact|||||2.14|0.08|0.4505
71147945|NCT00541658|141789885|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.82||||1|TWO_SIDED|95.0|0.22|3.03|||Fisher Exact|||||3.03|0.22|1.0000
71147946|NCT00541658|141789886|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.41||||0.4505|TWO_SIDED|95.0|0.08|2.11|||Fisher Exact|||||2.11|0.08|0.4505
71147947|NCT00541658|141789886|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.2||||0.7719|TWO_SIDED|95.0|0.37|3.9|||Fisher Exact|||||3.90|0.37|0.7719
71147948|NCT00541658|141789887|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.0||||1|TWO_SIDED|95.0|0.14|7.05|||Fisher Exact|||||7.05|0.14|1.0000
71147949|NCT00541658|141789887|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.5||||1|TWO_SIDED|95.0|0.25|8.9|||Fisher Exact|||||8.90|0.25|1.0000
70875407|NCT02533427|141234849|OTHER||% GLSM Ratio|115.02|||||TWO_SIDED|90.0|108.12|122.37|||||Test/Reference: Norgestrel Part B/Part A|Norgestrel Part B/Part A||122.37|108.12|
71147950|NCT00541658|141789888|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.03||||1|TWO_SIDED|95.0|0.15|7.29|||Fisher Exact|||||7.29|0.15|1.0000
70875408|NCT02533427|141234850|OTHER||% GLSM Ratio|121.06|||||TWO_SIDED|90.0|106.1|138.12|||||Test/Reference: Ethinyl estradiol Part B/Part A|Ethinyl estradiol Part B/Part A||138.12|106.10|
71147951|NCT00541658|141789888|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.49||||1|TWO_SIDED|95.0|0.25|8.87|||Fisher Exact|||||8.87|0.25|1.0000
71147952|NCT00541658|141789889|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.42||||0.4505|TWO_SIDED|95.0|0.08|2.14|||Fisher Exact|||||2.14|0.08|0.4505
71147953|NCT00541658|141789889|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.82||||1|TWO_SIDED|95.0|0.22|3.03|||Fisher Exact|||||3.03|0.22|1.0000
71147954|NCT00541658|141789890|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.41||||0.4505|TWO_SIDED|95.0|0.08|2.11|||Fisher Exact|||||2.11|0.08|0.4505
71147955|NCT00541658|141789890|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.2||||0.7719|TWO_SIDED|95.0|0.37|3.9|||Fisher Exact|||||3.90|0.37|0.7719
71147956|NCT02344108|141789943|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71147957|NCT02344108|141789944|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71147958|NCT02344108|141789945|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||0.035
71147959|NCT02344108|141789946|SUPERIORITY|||||||0.083|||||||t-test, 2 sided|||||||0.083
71147960|NCT02344108|141789947|SUPERIORITY|||||||0.0021|||||||t-test, 2 sided|||||||0.0021
71147961|NCT02344108|141789948|SUPERIORITY|||||||0.764|||||||t-test, 2 sided|||||||0.764
71147962|NCT02344108|141789949|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71147963|NCT02344108|141789950|SUPERIORITY|||||||0.467|||||||t-test, 2 sided|||||||0.467
71147964|NCT02344108|141789951|SUPERIORITY|||||||0.745|||||||t-test, 2 sided|||||||0.745
71147965|NCT02344108|141789952|SUPERIORITY|||||||0.106|||||||t-test, 2 sided|||||||0.106
71147966|NCT02344108|141789953|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71147967|NCT02344108|141789954|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71147968|NCT02344108|141789955|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71147969|NCT00911170|141789956|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41||||0.014|TWO_SIDED|95.0|0.19|0.86|||Cochran-Mantel-Haenszel|The p-value is adjusted for the randomization stratification factors (chemotherapy regimen, geographic region, disease stage).|Odds ratio adjusted for the randomization stratification factors. An OR \< 1.0 indicates a lower event rate for the pegfilgrastim arm relative to the placebo arm.|The primary hypothesis was that the percentage of participants treated with study chemotherapy and bevacizumab who experience grade 3/4 febrile neutropenia (FN) would be lower in participants randomized to the pegfilgrastim arm compared to placebo arm. The study was designed to have at least 90% power at the 2-sided 0.05 significance level to detect a 6% difference in incidence of grade 3/4 FN from 9% to 3%, which is approximately a 66.7% relative reduction.||0.86|0.19|0.014
71147970|NCT00911170|141789957|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.704|TWO_SIDED|95.0|0.81|1.36|||Log Rank|P-values based on the log-rank test statistic from the Kaplan-Meier survival analysis stratified by the 3 randomization factors.|Based on Cox proportional Hazard model stratified by chemotherapy regimen, region and disease status. A HR\< 1.0 indicates a lower average event rate and a longer survival time for the pegfilgrastim arm relative to the placebo arm.|||1.36|0.81|0.704
71147971|NCT00911170|141789958|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.552|TWO_SIDED|95.0|0.88|1.26|||Log Rank|P-values are based on the log-rank test statistic from the Kaplan-Meier survival analysis stratified by the 3 randomization factors.|Based on Cox proportional Hazard model stratified by chemotherapy regimen, region and disease status. A HR\< 1.0 indicates a lower average event rate and a longer survival time for the pegfilgrastim arm relative to the placebo arm.|||1.26|0.88|0.552
71147972|NCT00911170|141789959|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.502|TWO_SIDED|95.0|0.88|1.29|||Log Rank|P-values are based on the log-rank test statistic from the Kaplan-Meier survival analysis stratified by the 3 randomization factors.|Based on Cox proportional Hazard model stratified by chemotherapy regimen, region and disease status. A HR\< 1.0 indicates a lower average event rate and a longer survival time for the pegfilgrastim arm relative to the placebo arm.|||1.29|0.88|0.502
71147973|NCT00911170|141789960|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.683|TWO_SIDED|95.0|0.81|1.39|||Cochran-Mantel-Haenszel|The p-value is from the Cochran Mantel Haenszel (CMH) test adjusting for the randomization stratification factors.|Odds ratio (OR) adjusted for the randomization stratification factors. An OR \> 1.0 indicates a higher event rate for the pegfilgrastim arm relative to the placebo arm.|||1.39|0.81|0.683
71147974|NCT00911170|141789961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.312||95.0|0.29|1.49|||Cochran-Mantel-Haenszel|The p-value is from the Cochran Mantel Haenszel (CMH) test adjusting for the randomization stratification factors.|Odds ratio (OR) adjusted for the randomization stratification factors. An OR \< 1.0 indicates a lower event rate for the pegfilgrastim arm relative to the placebo arm.|||1.49|0.29|0.312
71147975|NCT00911170|141789962|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.18|||<|0.001||95.0|0.1|0.32|||Cochran-Mantel-Haenszel|The p-value is from the Cochran Mantel Haenszel (CMH) test adjusting for the randomization stratification factors.|Odds ratio (OR) adjusted for the randomization stratification factors. An OR \< 1.0 indicates a lower event rate for the pegfilgrastim arm relative to the placebo arm.|||0.32|0.10|<.001
71147976|NCT00911170|141789963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27|||<|0.001|TWO_SIDED|95.0|0.13|0.56|||Cochran-Mantel-Haenszel|The p-value is from the Cochran Mantel Haenszel (CMH) test adjusting for the randomization stratification factors.|Odds ratio (OR) adjusted for the randomization stratification factors. An OR \< 1.0 indicates a lower event rate for the pegfilgrastim arm relative to the placebo arm.|||0.56|0.13|<.001
71147977|NCT02230995|141790003|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% confidence intervals (CIs) for the ratios (test to reference treatment) of the adjusted geometric means (gMeans) of the primary endpoints, using an acceptance range of 80.00 to 125.00%.|Adjusted gMean ratio|98.22|STANDARD_DEVIATION|5.0|<|1e-05|TWO_SIDED|90.0|96.11|100.39|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of empagliflozin was estimated by the ratios of the adjusted gMean of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).|||100.39|96.11|<0.00001
71147978|NCT02230995|141790004|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% confidence intervals (CIs) for the ratios (test to reference treatment) of the adjusted geometric means (gMeans) of the primary endpoints, using an acceptance range of 80.00 to 125.00%.|Adjusted gMean ratio|102.14|STANDARD_DEVIATION|7.9|<|1e-05|TWO_SIDED|90.0|98.65|105.76|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of metformin was estimated by the ratios of the adjusted gMean of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).|||105.76|98.65|<0.00001
71147979|NCT02230995|141790005|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% confidence intervals (CIs) for the ratios (test to reference treatment) of the adjusted geometric means (gMeans) of the primary endpoints, using an acceptance range of 80.00 to 125.00%.|Adjusted gMean ratio|98.7|STANDARD_DEVIATION|12.3|<|1e-05|TWO_SIDED|90.0|93.51|104.17|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of empagliflozin was estimated by the ratios of the adjusted gMean of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).|||104.17|93.51|<0.00001
71147980|NCT02230995|141790006|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% confidence intervals (CIs) for the ratios (test to reference treatment) of the adjusted geometric means (gMeans) of the primary endpoints, using an acceptance range of 80.00 to 125.00%.|Adjusted gMean ratio|105.69|STANDARD_DEVIATION|10.9|<|1e-05|TWO_SIDED|90.0|100.78|110.84|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of metformin was estimated by the ratios of the adjusted gMean of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).|||110.84|100.78|<0.00001
70875409|NCT02533427|141234851|OTHER||% GLSM Ratio|112.11|||||TWO_SIDED|90.0|87.19|144.14|||||Test/Reference: Norgestimate Part B/Part A|Norgestimate Part B/Part A||144.14|87.19|
70875410|NCT02533427|141234852|OTHER||% GLSM Ratio|114.19|||||TWO_SIDED|90.0|107.4|121.39|||||Test/Reference: Norelgestromin Part B/Part A|Norelgestromin Part B/Part A||121.39|107.40|
71147981|NCT02230995|141790007|SUPERIORITY_OR_OTHER||Adjusted gMean ratio|98.32|STANDARD_DEVIATION|5.1|||TWO_SIDED|90.0|96.16|100.53|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of empagliflozin was estimated by ratios of adjusted geometric means (gMean) of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).|||100.53|96.16|
71147982|NCT02230995|141790008|SUPERIORITY_OR_OTHER||Adjusted gMean ratio|104.66|STANDARD_DEVIATION|7.3|||TWO_SIDED|90.0|101.36|108.07|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of metformin was estimated by the ratios of the adjusted geometric means (gMean) of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).|||108.07|101.36|
71147983|NCT02141295|141790009|OTHER||Hazard Ratio (HR)|0.91|||=|0.6753|TWO_SIDED|95.0|0.6|1.39||log-rank|Regression, Cox|||Kaplan-Meier methods were used to estimate median PFS for each treatment arm and the 95% CIs for median PFS were computed using the Brookmeyer and Crowley method. The stratified Cox proportional hazard was used to estimate the hazard ratio (i.e., the magnitude of the treatment effect) and the corresponding 95% confidence interval. The stratification factors are number of metastatic sites (1 vs. \>1) and country/region (USA vs rest of the world).||1.39|0.60|= 0.6753
71147984|NCT02141295|141790012|OTHER||Hazard Ratio (HR)|0.85|||=|0.574|TWO_SIDED|95.0|0.49|1.49|||Log Rank|||Kaplan-Meier methods were used to estimate median OS for each treatment arm and the 95% CIs for median OS were computed using the Brookmeyer and Crowley method. The stratified Cox proportional hazard was used to estimate the hazard ratio (i.e., the magnitude of the treatment effect) and the corresponding 95% confidence interval. The stratification factors are number of metastatic sites (1 vs. \>1) and country/region (USA vs rest of the world).||1.49|0.49|= 0.5740
71147985|NCT00071890|141790034|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||Chi-squared|||||||0.025
71147986|NCT00071890|141790035|SUPERIORITY_OR_OTHER|||||||0.069||95.0||||Biphasic decline of CD4 after week 24 : first slope before W32 and weaker decline until W168.Slopes significantly different (all p values ≤0.0001) between the 2 groups, more pronounced in the IL-2 groups|Wilcoxon (Mann-Whitney)|||||||0.069
71147987|NCT02144610|141790046|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||MI at 0-6 Months||||>0.999
71147988|NCT02144610|141790046|SUPERIORITY_OR_OTHER|||||||0.4889|||||||Fisher Exact|||MI at 0-12 Months||||0.4889
71147989|NCT02144610|141790046|SUPERIORITY_OR_OTHER|||||||0.4889|||||||Fisher Exact|||MI at 0-18 Months||||0.4889
71147990|NCT02144610|141790046|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Stroke at 0-6 Months||||>0.999
71147991|NCT02144610|141790046|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Stroke at 0-12 Months||||>0.999
71147992|NCT02144610|141790046|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Stroke at 0-18 Months||||>0.999
71147993|NCT02144610|141790046|SUPERIORITY_OR_OTHER|||||||0.7381|||||||Fisher Exact|||Major amputation at 0-6 Months||||0.7381
71147994|NCT02144610|141790046|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Major amputation at 0-12 Months||||>0.999
71147995|NCT02144610|141790046|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Major amputation at 0-18 Months||||>0.999
71147996|NCT02144610|141790046|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Revascularization at 0-6 Months||||>0.999
71147997|NCT02144610|141790046|SUPERIORITY_OR_OTHER|||||||0.4591|||||||Fisher Exact|||Revascularization at 0-12 Months||||0.4591
71147998|NCT02144610|141790046|SUPERIORITY_OR_OTHER|||||||0.4591|||||||Fisher Exact|||Revascularization at 0-18 Months||||0.4591
71147999|NCT02144610|141790046|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||All-cause death at 0-6 Months||||>0.999
71148000|NCT02144610|141790046|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||All-cause death at 0-12 Months||||>0.999
71148001|NCT02144610|141790046|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||All-cause death at 0-18 Months||||>0.999
71148002|NCT02144610|141790046|SUPERIORITY_OR_OTHER|||||||0.5136|||||||Fisher Exact|||0-6 Months (Major Amputation or Death)||||0.5136
71148003|NCT02144610|141790046|SUPERIORITY_OR_OTHER|||||||0.7575|||||||Fisher Exact|||0-12 Months (Major Amputation or Death)||||0.7575
71148004|NCT02144610|141790046|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||0-18 Months (Major Amputation or Death)||||>0.999
71148005|NCT02144610|141790046|SUPERIORITY_OR_OTHER|||||||0.7575|||||||Fisher Exact|||0-6 Months (Major Amputation or Revascularization)||||0.7575
71148006|NCT02144610|141790046|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||0-12 Months (Major Amputation or Revascularization)||||>0.999
71148007|NCT02144610|141790046|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||0-18 Months (Major Amputation or Revascularization)||||>0.999
71148008|NCT02144610|141790047|SUPERIORITY_OR_OTHER|||||||0.514|||||||ANCOVA|||Change from Baseline at Month 3||||0.514
71148009|NCT02144610|141790047|SUPERIORITY_OR_OTHER|||||||0.445|||||||ANCOVA|||Change from Baseline at Month 6||||0.445
70875411|NCT02533427|141234853|OTHER||% GLSM Ratio|121.62|||||TWO_SIDED|90.0|110.85|133.44|||||Test/Reference: Norgestrel Part B/Part A|Norgestrel Part B/Part A||133.44|110.85|
70875412|NCT02533427|141234854|OTHER||% GLSM Ratio|92.86|||||TWO_SIDED|90.0|82.55|104.45|||||Test/Reference: Ethinyl estradiol Part B/Part A|Ethinyl estradiol Part B/Part A||104.45|82.55|
70955973|NCT00548262|141415199|SUPERIORITY_OR_OTHER||percentage of participants with success|51.6|||||TWO_SIDED|95.0|34.0|69.2|||||95% CI based on normal approximation to the binomial.|TPN (No): Success||69.2|34.0|
70955974|NCT00548262|141415199|SUPERIORITY_OR_OTHER||percentage of participants with success|14.3|||||TWO_SIDED|95.0|0.0|40.2|||||95% CI based on normal approximation to the binomial.|Dialysis (Yes): Success||40.2|0.0|
71148010|NCT02144610|141790047|SUPERIORITY_OR_OTHER|||||||0.863|||||||ANCOVA|||Change from Baseline at Month 9||||0.863
71148011|NCT02144610|141790047|SUPERIORITY_OR_OTHER|||||||0.111|||||||ANCOVA|||Change from Baseline at Month 12||||0.111
71148012|NCT02144610|141790047|SUPERIORITY_OR_OTHER|||||||0.153|||||||ANCOVA|||Change from Baseline at Month 15||||0.153
71148013|NCT02144610|141790047|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANCOVA|||Change from Baseline at last observation carried forward (LOCF)||||0.002
71148014|NCT02144610|141790050|SUPERIORITY_OR_OTHER|||||||0.733|||||||ANCOVA|||Change from baseline at Month 3 (right brachial)||||0.733
71148015|NCT02144610|141790050|SUPERIORITY_OR_OTHER|||||||0.808|||||||ANCOVA|||Change from baseline at Month 6 (right brachial)||||0.808
71148016|NCT02144610|141790050|SUPERIORITY_OR_OTHER|||||||0.487|||||||ANCOVA|||Change from baseline at Month 9 (right brachial)||||0.487
71148017|NCT02144610|141790050|SUPERIORITY_OR_OTHER|||||||0.216|||||||ANCOVA|||Change from baseline at Month 12 (right brachial)||||0.216
71148018|NCT02144610|141790050|SUPERIORITY_OR_OTHER|||||||0.896|||||||ANCOVA|||Change from baseline at Month 15 (right brachial)||||0.896
70875413|NCT01830699|141234890|NON_INFERIORITY_OR_EQUIVALENCE|For details of power calculation, see above. Using a minimal clinical importance of -9.1, the null hypothesis was a mean difference less than -9.1.|Mean Difference (Final Values)|-23.9||||0.004|||||||t-test, 2 sided|||"Setting α=0.05 and β=0.8, with effect size of 0.17 anticipated total n = 138 to be recruited (requested recruitment of 150 to account for possible drop-outs)~1st data analysis (n = 33), effect size calculated at 1.1 with new n = 29 with α=0.05 and β=1.0."||||0.004
70875414|NCT01830699|141234891|NON_INFERIORITY_OR_EQUIVALENCE|See details above regarding effect size, power, etc.||||||0.044|||||||t-test, 2 sided|||"Setting α=0.05 and β=0.8, with effect size of 0.17 anticipated total n = 138 to be recruited (requested recruitment of 150 to account for possible drop-outs)~1st data analysis (n = 33), effect size calculated at 1.1 with new n = 29 with α=0.05 and β=1.0."||||0.044
71148019|NCT02144610|141790050|SUPERIORITY_OR_OTHER|||||||0.167|||||||ANCOVA|||Change from baseline at last observation carried forward (LOCF) (right brachial)||||0.167
71148020|NCT02144610|141790050|SUPERIORITY_OR_OTHER|||||||0.378|||||||ANCOVA|||Change from baseline at Month 3 (left brachial)||||0.378
71148021|NCT02144610|141790050|SUPERIORITY_OR_OTHER|||||||0.39|||||||ANCOVA|||Change from baseline at Month 6 (left brachial)||||0.390
71148022|NCT02144610|141790050|SUPERIORITY_OR_OTHER|||||||0.521|||||||ANCOVA|||Change from baseline at Month 9 (left brachial)||||0.521
71148023|NCT02144610|141790050|SUPERIORITY_OR_OTHER|||||||0.044|||||||ANCOVA|||Change from baseline at Month 12 (left brachial)||||0.044
71148024|NCT02144610|141790050|SUPERIORITY_OR_OTHER|||||||0.423|||||||ANCOVA|||Change from baseline at Month 15 (left brachial)||||0.423
71148025|NCT02144610|141790050|SUPERIORITY_OR_OTHER|||||||0.989|||||||ANCOVA|||Change from baseline at LOCF (left brachial)||||0.989
71148026|NCT02144610|141790051|SUPERIORITY_OR_OTHER|||||||0.803|||||||ANCOVA|||Change from Baseline at Month 3 (Dorsalis Pedis)||||0.803
71148027|NCT02144610|141790051|SUPERIORITY_OR_OTHER|||||||0.668|||||||ANCOVA|||Change from Baseline at Month 6 (Dorsalis Pedis)||||0.668
71148028|NCT02144610|141790051|SUPERIORITY_OR_OTHER|||||||0.789|||||||ANCOVA|||Change from Baseline at Month 9 (Dorsalis Pedis)||||0.789
71148029|NCT02144610|141790051|SUPERIORITY_OR_OTHER|||||||0.28|||||||ANCOVA|||Change from Baseline at Month 12 (Dorsalis Pedis)||||0.280
71148030|NCT02144610|141790051|SUPERIORITY_OR_OTHER|||||||0.324|||||||ANCOVA|||Change from Baseline at LOCF (Dorsalis Pedis)||||0.324
71148031|NCT02144610|141790051|SUPERIORITY_OR_OTHER|||||||0.759|||||||ANCOVA|||Change from Baseline at Month 3 (Posterior Tibial)||||0.759
70875415|NCT02288559|141234909|SUPERIORITY||Difference in Adjusted Means|0.435||||0.0428|TWO_SIDED|80.0|0.162|0.707|||Mixed-Effect Model Repeated Measures|MMRM analysis variables: treatment group, visit, treatment-by-visit interaction, baseline GA area, and BCVA ETDRS chart Snellen equivalent category.||||0.707|0.162|0.0428
70875416|NCT02288559|141234909|SUPERIORITY||Difference in Adjusted Means|-0.21||||0.3361|TWO_SIDED|80.0|-0.491|0.071|||MMRM|MMRM analysis variables: treatment group, visit, treatment-by-visit interaction, baseline GA area, and BCVA ETDRS chart Snellen equivalent category.||||0.071|-0.491|0.3361
71148032|NCT02144610|141790051|SUPERIORITY_OR_OTHER|||||||0.414|||||||ANCOVA|||Change from Baseline at Month 6 (Posterior Tibial)||||0.414
71148033|NCT02144610|141790051|SUPERIORITY_OR_OTHER|||||||0.886|||||||ANCOVA|||Change from Baseline at Month 9 (Posterior Tibial)||||0.886
71148034|NCT02144610|141790051|SUPERIORITY_OR_OTHER|||||||0.114|||||||ANCOVA|||Change from Baseline at Month 12 (Posterior Tibial)||||0.114
70875417|NCT02746874|141234948|SUPERIORITY|||||||0.978|||||||Wilcoxon (Mann-Whitney)|||||||.978
70875418|NCT02746874|141234950|SUPERIORITY|||||||0.978|||||||Wilcoxon (Mann-Whitney)|||||||.978
71148035|NCT02144610|141790051|SUPERIORITY_OR_OTHER|||||||0.051|||||||ANCOVA|||Change from Baseline at LOCF (Posterior Tibial)||||0.051
71148036|NCT02144610|141790052|SUPERIORITY_OR_OTHER|||||||0.211|||||||ANCOVA|||Change from Baseline at Month 3||||0.211
71148037|NCT02144610|141790052|SUPERIORITY_OR_OTHER|||||||0.036|||||||ANCOVA|||Change from Baseline at Month 6||||0.036
71148038|NCT02144610|141790052|SUPERIORITY_OR_OTHER|||||||0.725|||||||ANCOVA|||Change from Baseline at Month 9||||0.725
71148039|NCT02144610|141790052|SUPERIORITY_OR_OTHER|||||||0.468|||||||ANCOVA|||Change from Baseline at Month 12||||0.468
71148040|NCT02144610|141790052|SUPERIORITY_OR_OTHER|||||||0.854|||||||ANCOVA|||Change from Baseline at Month 15||||0.854
71148041|NCT02144610|141790052|SUPERIORITY_OR_OTHER|||||||0.233|||||||ANCOVA|||Change from Baseline at LOCF||||0.233
71148042|NCT02144610|141790053|SUPERIORITY_OR_OTHER|||||||0.268|||||||ANCOVA|||Change from Baseline at Month 3||||0.268
71148043|NCT02144610|141790053|SUPERIORITY_OR_OTHER|||||||0.32|||||||ANCOVA|||Change from Baseline at Month 6||||0.320
71148044|NCT02144610|141790053|SUPERIORITY_OR_OTHER|||||||0.315|||||||ANCOVA|||Change from Baseline at Month 9||||0.315
70875419|NCT02746874|141234951|SUPERIORITY|||||||0.371|||||||t-test, 2 sided|||||||.371
71148045|NCT02144610|141790053|SUPERIORITY_OR_OTHER|||||||0.327|||||||ANCOVA|||Change from Baseline at Month 12||||0.327
71148046|NCT02144610|141790053|SUPERIORITY_OR_OTHER|||||||0.643|||||||ANCOVA|||Change from Baseline at Month 15||||0.643
71148047|NCT02144610|141790053|SUPERIORITY_OR_OTHER|||||||0.74|||||||ANCOVA|||Change from Baseline at LOCF||||0.740
71148048|NCT02144610|141790054|SUPERIORITY_OR_OTHER|||||||0.147|||||||ANCOVA|||Change from Baseline at Month 3||||0.147
71148049|NCT02144610|141790054|SUPERIORITY_OR_OTHER|||||||0.032|||||||ANCOVA|||Change from Baseline at Month 6||||0.032
71148050|NCT02144610|141790054|SUPERIORITY_OR_OTHER|||||||0.709|||||||ANCOVA|||Change from Baseline at Month 9||||0.709
71148051|NCT02144610|141790054|SUPERIORITY_OR_OTHER|||||||0.771|||||||ANCOVA|||Change from Baseline at Month 12||||0.771
71148052|NCT02144610|141790054|SUPERIORITY_OR_OTHER|||||||0.83|||||||ANCOVA|||Change from Baseline at Month 15||||0.830
71148053|NCT02144610|141790054|SUPERIORITY_OR_OTHER|||||||0.033|||||||ANCOVA|||Change from Baseline at LOCF||||0.033
71148054|NCT02144610|141790055|SUPERIORITY_OR_OTHER|||||||0.105|||||||ANCOVA|||Pain (LOCF)||||0.105
70875420|NCT02746874|141234952|SUPERIORITY|||||||0.325|||||||t-test, 2 sided|||||||.325
71148055|NCT02144610|141790055|SUPERIORITY_OR_OTHER|||||||0.557|||||||ANCOVA|||Symptom (LOCF)||||0.557
71148056|NCT02144610|141790055|SUPERIORITY_OR_OTHER|||||||0.94|||||||ANCOVA|||Activities (LOCF)||||0.940
71148057|NCT02144610|141790055|SUPERIORITY_OR_OTHER|||||||0.905|||||||ANCOVA|||Social (LOCF)||||0.905
71148058|NCT02144610|141790055|SUPERIORITY_OR_OTHER|||||||0.782|||||||ANCOVA|||Emotional Functioning (LOCF)||||0.782
71148059|NCT02144610|141790055|SUPERIORITY_OR_OTHER|||||||0.802|||||||ANCOVA|||Composite Overall (LOCF)||||0.802
70875421|NCT02746874|141234953|SUPERIORITY|||||||0.466|||||||t-test, 2 sided|||||||.466
70875422|NCT02746874|141234954|SUPERIORITY|||||||0.368|||||||Wilcoxon (Mann-Whitney)|||||||.368
71148060|NCT02144610|141790056|SUPERIORITY_OR_OTHER|||||||0.941|||||||ANCOVA|||Change from Baseline at Month 3||||0.941
71148061|NCT02144610|141790056|SUPERIORITY_OR_OTHER|||||||0.584|||||||ANCOVA|||Change from Baseline at Month 6||||0.584
70875423|NCT02746874|141234955|SUPERIORITY|||||||0.509|||||||Wilcoxon (Mann-Whitney)|||||||.509
71148062|NCT02144610|141790056|SUPERIORITY_OR_OTHER|||||||0.1|||||||ANCOVA|||Change from Baseline at Month 9||||0.100
71148063|NCT02144610|141790056|SUPERIORITY_OR_OTHER|||||||0.916|||||||ANCOVA|||Change from Baseline at Month 12||||0.916
70875424|NCT02746874|141234956|SUPERIORITY|||||||0.593|||||||Wilcoxon (Mann-Whitney)|||||||.593
70875425|NCT02746874|141234957|SUPERIORITY|||||||0.687|||||||Wilcoxon (Mann-Whitney)|||||||0.687
70875426|NCT02746874|141234958|SUPERIORITY|||||||0.813|||||||Wilcoxon (Mann-Whitney)|||||||.813
70875427|NCT02746874|141234959|SUPERIORITY|||||||0.687|||||||Wilcoxon (Mann-Whitney)|||||||.687
70875428|NCT02746874|141234960|SUPERIORITY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||||||0.840
70875429|NCT02746874|141234961|SUPERIORITY|||||||0.913|||||||Wilcoxon (Mann-Whitney)|||||||.913
71148064|NCT02144610|141790056|SUPERIORITY_OR_OTHER|||||||0.486|||||||ANCOVA|||Change from Baseline at Month 15||||0.486
71148065|NCT02144610|141790056|SUPERIORITY_OR_OTHER|||||||0.835|||||||ANCOVA|||Change from Baseline at LOCF||||0.835
71148066|NCT01399372|141790064|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.015|TWO_SIDED|95.0|0.27|0.95||One-sided significance level = 0.15|Log Rank||Reference arm = Chemotherapy|Sample size of 89 provided 80% power to detect a hazard ratio of 0.63 at a one-sided alpha level of 0.15.||0.95|0.27|0.015
71148067|NCT01399372|141790065|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.48|TWO_SIDED|95.0|0.38|1.58||Two-sided significance level = 0.05|Log Rank||Reference arm = Chemotherapy|||1.58|0.38|0.48
71148068|NCT01399372|141790067|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|||A mixed effects model of EORTC QLQ-C30 GHS was run with independent variables treatment arm, time, baseline Memorial Sloan-Kettering Cancer Center (MSKCC) recursive partitioning analysis (RPA) class, and baseline neurologic symptoms (none/minor vs. moderate/severe), including the interaction of treatment and time, representing difference in the longitudinal trajectory of the scores between the treatment arms. Prospectively, the interaction effect was of most interest and is reported here,||||0.005
71148069|NCT01399372|141790068|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.18|TWO_SIDED|95.0|0.21|1.31|||Gray's test||Reference arm = Chemotherapy arm|||1.31|0.21|0.18
71148070|NCT01432730|141790070|SUPERIORITY||Log mean difference (Active - Placebo)|-0.6027||||0.0003|TWO_SIDED|95.0|-0.9049|-0.3005|||Mixed Models Analysis|Mixed model included terms for treatment sequence, participant within sequence, treatment \& period. Average \& period baseline covariates included.||||-0.3005|-0.9049|0.0003
71148071|NCT01432730|141790071|SUPERIORITY||Mean Difference (Final Values)|-25.57||||0.003|TWO_SIDED|95.0|-41.53|-9.62|||Mixed Models Analysis|Mixed effect model fitting terms for treatment sequence, participant within sequence, treatment, and period.||||-9.62|-41.53|0.003
70875430|NCT02746874|141234962|SUPERIORITY|||||||0.301|||||||Wilcoxon (Mann-Whitney)|||||||0.301
70875431|NCT02746874|141234963|SUPERIORITY|||||||0.826|||||||Wilcoxon (Mann-Whitney)|||||||0.826
70875432|NCT02746874|141234964|SUPERIORITY|||||||0.813|||||||Wilcoxon (Mann-Whitney)|||||||.813
70875433|NCT02746874|141234966|SUPERIORITY|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||||||.047
70875434|NCT02746874|141234967|SUPERIORITY|||||||0.115|||||||Wilcoxon (Mann-Whitney)|||||||.115
71148072|NCT01432730|141790072|SUPERIORITY||Log mean difference (Active - Placebo)|-0.4212||||0.057|TWO_SIDED|95.0|-0.8568|0.01438|||Mixed Models Analysis|Mixed model included terms for treatment sequence, participant within sequence, treatment \& period. Average \& period baseline covariates included.||||0.01438|-0.8568|0.057
71148073|NCT01432730|141790073|SUPERIORITY||Mean Difference (Final Values)|-8.53||||0.172|TWO_SIDED|95.0|-20.93|3.87|||Mixed Models Analysis|Mixed effect model fitting terms for treatment sequence, participant within sequence, treatment, and period.||||3.87|-20.93|0.172
71148074|NCT01432730|141790074|SUPERIORITY||Log mean difference (Active - Placebo)|-0.582||||0.001|TWO_SIDED|95.0|-0.8934|-0.2707|||Mixed Models Analysis|Mixed model included terms for treatment sequence, participant within sequence, treatment \& period. Average \& period baseline covariates included.||||-0.2707|-0.8934|0.001
71148075|NCT01432730|141790075|SUPERIORITY||Mean Difference (Final Values)|-2.538||||0.033|TWO_SIDED|95.0|-4.849|-0.227|||Mixed Models Analysis|Mixed effect model fitting terms for treatment sequence, participant within sequence, treatment, and period.||||-0.227|-4.849|0.033
71148076|NCT01432730|141790076|SUPERIORITY||Median Difference (Final Values)|-2.267||||0.049|TWO_SIDED|95.0|-4.523|-0.01|||Mixed Models Analysis|Mixed effect model fitting terms for treatment sequence, participant within sequence, treatment, and period.||||-0.010|-4.523|0.049
71148077|NCT01432730|141790077|SUPERIORITY||Mean Difference (Final Values)|-9.237||||0.018|TWO_SIDED|95.0|-16.759|-1.716|||Mixed Models Analysis|Mixed effect model fitting terms for treatment sequence, participant within sequence, treatment, and period.||||-1.716|-16.759|0.018
71148078|NCT01432730|141790078|SUPERIORITY||Mean Difference (Final Values)|-21.25||||0.035|TWO_SIDED|95.0|-40.96|-1.54|||Mixed Models Analysis|Mixed effect model fitting terms for treatment sequence, participant within sequence, treatment, and period.||||-1.54|-40.96|0.035
71148079|NCT01298648|141790104|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|Paired t-test using observed cases at Baseline and Week 4.||||||<0.0001
71148080|NCT01298648|141790106|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 1 sided|Paired t-test using observed values at Baseline and Week 8.||||||<0.0001
71148081|NCT01298648|141790107|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|Paired t-test using observed values at Baseline and Week 24.||||||<0.0001
71148082|NCT02085161|141790135|SUPERIORITY_OR_OTHER||Treatment ratio|1.458|STANDARD_ERROR_OF_MEAN|0.147||0.0002|TWO_SIDED|95.0|1.196|1.777||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM).|This treatment comparison is the first one in the alpha-protected hierarchical testing chain.||1.777|1.196|0.0002
71148083|NCT02085161|141790135|SUPERIORITY_OR_OTHER||Treatment ratio|1.292|STANDARD_ERROR_OF_MEAN|0.129||0.0109|TWO_SIDED|95.0|1.061|1.573||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM).|This treatment comparison is the second one in the alpha-protected hierarchical testing chain.||1.573|1.061|0.0109
71148084|NCT02085161|141790135|SUPERIORITY_OR_OTHER||Treatment ratio|1.041|STANDARD_ERROR_OF_MEAN|0.106||0.6895|TWO_SIDED|95.0|0.853|1.272||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM).|This treatment comparison is the third one in the alpha-protected hierarchical testing chain. Since the p-value for this treatment comparison is \>0.05, the hierarchical testing chain is broken and all of the following hypothesis tests in this hierarchical chain are considered as descriptive only.||1.272|0.853|0.6895
71148085|NCT02085161|141790135|SUPERIORITY_OR_OTHER||Treatment ratio|1.128|STANDARD_ERROR_OF_MEAN|0.11||0.2188|TWO_SIDED|95.0|0.931|1.368||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM.|||1.368|0.931|0.2188
71148086|NCT02085161|141790135|SUPERIORITY_OR_OTHER||Treatment ratio|1.241|STANDARD_ERROR_OF_MEAN|0.123||0.0303|TWO_SIDED|95.0|1.021|1.507||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM.|||1.507|1.021|0.0303
71148087|NCT02085161|141790136|SUPERIORITY_OR_OTHER||LSMean Difference|-331.975|STANDARD_ERROR_OF_MEAN|296.375||0.2639|TWO_SIDED|95.0|-916.015|252.064||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)|||252.064|-916.015|0.2639
70875435|NCT02746874|141234968|SUPERIORITY|||||||0.349|||||||Wilcoxon (Mann-Whitney)|||||||.349
71148088|NCT02085161|141790136|SUPERIORITY_OR_OTHER||LSMean Difference|161.072|STANDARD_ERROR_OF_MEAN|293.506||0.5837|TWO_SIDED|95.0|-417.314|739.459||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)|||739.459|-417.314|0.5837
71148089|NCT02085161|141790136|SUPERIORITY_OR_OTHER||LSMean Difference|-524.926|STANDARD_ERROR_OF_MEAN|296.802||0.0783|TWO_SIDED|95.0|-1109.806|59.954||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)|||59.954|-1109.806|0.0783
70875436|NCT02320149|141234972|SUPERIORITY||Least Squares Mean Difference|-5.2|||<|0.0001|TWO_SIDED|95.0|-6.7|-3.6||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|||-3.6|-6.7|< 0.0001
71148090|NCT02085161|141790136|SUPERIORITY_OR_OTHER||LSMean Difference|-493.048|STANDARD_ERROR_OF_MEAN|289.566||0.09|TWO_SIDED|95.0|-1063.67|77.575||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM|||77.575|-1063.670|0.0900
71148091|NCT02085161|141790136|SUPERIORITY_OR_OTHER||LSMean Difference|685.998|STANDARD_ERROR_OF_MEAN|289.435||0.0186|TWO_SIDED|95.0|115.635|1256.362||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM|||1256.362|115.635|0.0186
71148092|NCT02085161|141790137|SUPERIORITY_OR_OTHER||LSMean Difference|-0.002|STANDARD_ERROR_OF_MEAN|0.004||0.5186|TWO_SIDED|95.0|-0.01|0.005||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)|||0.005|-0.010|0.5186
71148093|NCT02085161|141790137|SUPERIORITY_OR_OTHER||LSMean Difference|0.002|STANDARD_ERROR_OF_MEAN|0.004||0.6436|TWO_SIDED|95.0|-0.006|0.009||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)|||0.009|-0.006|0.6436
71148094|NCT02085161|141790137|SUPERIORITY_OR_OTHER||LSMean Difference|-0.006|STANDARD_ERROR_OF_MEAN|0.004||0.1081|TWO_SIDED|95.0|-0.014|0.001||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)|||0.001|-0.014|0.1081
71148095|NCT02085161|141790137|SUPERIORITY_OR_OTHER||LSMean Difference|-0.004|STANDARD_ERROR_OF_MEAN|0.004||0.2612|TWO_SIDED|95.0|-0.011|0.003||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM|||0.003|-0.011|0.2612
71148096|NCT02085161|141790137|SUPERIORITY_OR_OTHER||LSMean Difference|0.008|STANDARD_ERROR_OF_MEAN|0.004||0.0361|TWO_SIDED|95.0|0.001|0.015||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM|||0.015|0.001|0.0361
71148097|NCT02085161|141790138|SUPERIORITY_OR_OTHER||LSMean Difference|0.076|STANDARD_ERROR_OF_MEAN|0.056||0.1727|TWO_SIDED|95.0|-0.034|0.187||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)|||0.187|-0.034|0.1727
71148098|NCT02085161|141790138|SUPERIORITY_OR_OTHER||LSMean Difference|0.143|STANDARD_ERROR_OF_MEAN|0.055||0.0097|TWO_SIDED|95.0|0.035|0.252||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)|||0.252|0.035|0.0097
71148099|NCT02085161|141790138|SUPERIORITY_OR_OTHER||LSMean Difference|0.016|STANDARD_ERROR_OF_MEAN|0.056||0.7815|TWO_SIDED|95.0|-0.095|0.126||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)|||0.126|-0.095|0.7815
71148100|NCT02085161|141790138|SUPERIORITY_OR_OTHER||LSMean Difference|-0.067|STANDARD_ERROR_OF_MEAN|0.054||0.2183|TWO_SIDED|95.0|-0.174|0.04||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM|||0.040|-0.174|0.2183
71148101|NCT02085161|141790138|SUPERIORITY_OR_OTHER||LSMean Difference|0.128|STANDARD_ERROR_OF_MEAN|0.055||0.0203|TWO_SIDED|95.0|0.02|0.236||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM|||0.236|0.020|0.0203
71148102|NCT02085161|141790139|SUPERIORITY_OR_OTHER||Treatment ratio|1.333|STANDARD_ERROR_OF_MEAN|0.142||0.0077|TWO_SIDED|95.0|1.08|1.645||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM).|||1.645|1.080|0.0077
71148103|NCT02085161|141790139|SUPERIORITY_OR_OTHER||Treatment ratio|1.244|STANDARD_ERROR_OF_MEAN|0.131||0.039|TWO_SIDED|95.0|1.011|1.53||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM).|||1.530|1.011|0.0390
71148104|NCT02085161|141790139|SUPERIORITY_OR_OTHER||Treatment ratio|1.051|STANDARD_ERROR_OF_MEAN|0.113||0.6452|TWO_SIDED|95.0|0.85|1.299||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM).|||1.299|0.850|0.6452
71148105|NCT02085161|141790139|SUPERIORITY_OR_OTHER||Treatment ratio|1.071|STANDARD_ERROR_OF_MEAN|0.111||0.5048|TWO_SIDED|95.0|0.874|1.313||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM.|||1.313|0.874|0.5048
71148106|NCT02085161|141790139|SUPERIORITY_OR_OTHER||Treatment ratio|1.184|STANDARD_ERROR_OF_MEAN|0.123||0.1066|TWO_SIDED|95.0|0.964|1.453||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM.|||1.453|0.964|0.1066
71148107|NCT02085161|141790140|SUPERIORITY_OR_OTHER||LSMean Difference|0.329|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.255|0.403||Mixed effect Model Repeat Measurement (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)|||0.403|0.255|<0.0001
71148108|NCT02085161|141790140|SUPERIORITY_OR_OTHER||LSMean Difference|0.356|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|0.282|0.429||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)|||0.429|0.282|<0.0001
71148109|NCT02085161|141790140|SUPERIORITY_OR_OTHER||LSMean Difference|0.174|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.099|0.249||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)|||0.249|0.099|<0.0001
71148110|NCT02085161|141790140|SUPERIORITY_OR_OTHER||LSMean Difference|-0.027|STANDARD_ERROR_OF_MEAN|0.037||0.4677|TWO_SIDED|95.0|-0.099|0.045||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM|||0.045|-0.099|0.4677
71148111|NCT02085161|141790140|SUPERIORITY_OR_OTHER||LSMean Difference|0.182|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|0.109|0.255||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM|||0.255|0.109|<0.0001
71148112|NCT02085161|141790141|SUPERIORITY_OR_OTHER||LSMean Difference|0.478|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001|TWO_SIDED|95.0|0.35|0.606||Mixed effect Model Repeat Measurement (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)|||0.606|0.350|<0.0001
71148113|NCT02085161|141790141|SUPERIORITY_OR_OTHER||LSMean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.064|<|0.0001|TWO_SIDED|95.0|0.403|0.657||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)|||0.657|0.403|<0.0001
71148114|NCT02085161|141790141|SUPERIORITY_OR_OTHER||LSMean Difference|0.286|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|0.157|0.415||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)|||0.415|0.157|<0.0001
71148115|NCT02085161|141790141|SUPERIORITY_OR_OTHER||LSMean Difference|-0.052|STANDARD_ERROR_OF_MEAN|0.063||0.4107|TWO_SIDED|95.0|-0.176|0.072||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM|||0.072|-0.176|0.4107
71148116|NCT02085161|141790141|SUPERIORITY_OR_OTHER||LSMean Difference|0.244|STANDARD_ERROR_OF_MEAN|0.064||0.0002|TWO_SIDED|95.0|0.119|0.37||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM|||0.370|0.119|0.0002
71148117|NCT02085161|141790142|SUPERIORITY_OR_OTHER||LSMean Difference|0.318|STANDARD_ERROR_OF_MEAN|0.071|<|0.0001|TWO_SIDED|95.0|0.179|0.457||Mixed effect Model Repeat Measurement (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)|||0.457|0.179|<0.0001
71148118|NCT02085161|141790142|SUPERIORITY_OR_OTHER||LSMean Difference|0.302|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|0.165|0.439||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)|||0.439|0.165|<0.0001
71148119|NCT02085161|141790142|SUPERIORITY_OR_OTHER||LSMean Difference|0.174|STANDARD_ERROR_OF_MEAN|0.071||0.0145|TWO_SIDED|95.0|0.035|0.314||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)|||0.314|0.035|0.0145
71148120|NCT02085161|141790142|SUPERIORITY_OR_OTHER||LSMean Difference|0.016|STANDARD_ERROR_OF_MEAN|0.068||0.815|TWO_SIDED|95.0|-0.118|0.151||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM|||0.151|-0.118|0.8150
70875437|NCT02320149|141234973|SUPERIORITY||Treatment Rate Difference|11.05|||<|0.0001|TWO_SIDED|95.0|6.39|15.72||P-values were based on the test of general association between the response and treatment group using Cochran-Mantel-Haenszel test with pooled site as stratification factor.|Cochran-Mantel-Haenszel||sarecycline - placebo|||15.72|6.39|< 0.0001
71148121|NCT02085161|141790142|SUPERIORITY_OR_OTHER||LSMean Difference|0.128|STANDARD_ERROR_OF_MEAN|0.069||0.0642|TWO_SIDED|95.0|-0.008|0.263||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM|||0.263|-0.008|0.0642
71148122|NCT03651479|141790162|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
71148123|NCT02399163|141790170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.76|||<|0.0001|TWO_SIDED|95.0|11.061|22.454||From ANOVA: participant (random), treatment (fixed), period (fixed)|ANCOVA||Difference is Placebo dentifrice/Fluoride rinse minus Placebo dentifrice/No rinse such that a positive difference implies a larger response value for the Placebo dentifrice/Fluoride rinse.|||22.454|11.061|<0.0001
71148124|NCT00728689|141790251|SUPERIORITY_OR_OTHER|||||||0.4591|||||||ANOVA|||A sample size of 12 subjects was chosen to provide a statistical power of 80% to detect a 25% difference of the Form V mean between the Form I and Form V doses at the 0.05 level (2-sided) for this crossover design. A parametric (normal theory) general linear model was applied and an ANOVA for a 2-way crossover design was employed to examine the differences among the 2 forms.||||0.4591
70875438|NCT02320149|141234974|SUPERIORITY||Least Squares Mean Difference|-16.7|||<|0.0001|TWO_SIDED|95.0|-21.9|-11.6||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 12||-11.6|-21.9|< 0.0001
71148125|NCT00728689|141790252|SUPERIORITY_OR_OTHER|||||||0.0048|||||||ANOVA|||A sample size of 12 subjects was chosen to provide a statistical power of 80% to detect a 25% difference of the Form V mean between the Form I and Form V doses at the 0.05 level (2-sided) for this crossover design. Firstly, a parametric (normal theory) general linear model was applied and an ANOVA for a 2-way crossover design was employed to examine the differences among the 2 forms. Secondly, AUC0-τ was analyzed on a log scale, to assess bioequivalence between Form I and Form V.||||0.0048
71148126|NCT00728689|141790253|SUPERIORITY_OR_OTHER|||||||0.0997|||||||ANOVA|||A sample size of 12 subjects was chosen to provide a statistical power of 80% to detect a 25% difference of the Form V mean between the Form I and Form V doses at the 0.05 level (2-sided) for this crossover design. Firstly, a parametric (normal theory) general linear model was applied and an ANOVA for a 2-way crossover design was employed to examine the differences among the 2 forms. Secondly, AUC0-∞ was analyzed on a log scale, to assess bioequivalence between Form I and Form V.||||0.0997
71148127|NCT00728689|141790254|SUPERIORITY_OR_OTHER|||||||0.0422|||||||ANOVA|||A sample size of 12 subjects was chosen to provide a statistical power of 80% to detect a 25% difference of the Form V mean between the Form I and Form V doses at the 0.05 level (2-sided) for this crossover design. Firstly, a parametric (normal theory) general linear model was applied and an ANOVA for a 2-way crossover design was employed to examine the differences among the 2 forms. Secondly, Cmax was analyzed on a log scale, to assess bioequivalence between Form I and Form V.||||0.0422
71148128|NCT00728689|141790255|SUPERIORITY_OR_OTHER|||||||0.8581|||||||ANOVA|||A sample size of 12 subjects was chosen to provide a statistical power of 80% to detect a 25% difference of the Form V mean between the Form I and Form V doses at the 0.05 level (2-sided) for this crossover design. A parametric (normal theory) general linear model was applied and an ANOVA for a 2-way crossover design was employed to examine the differences among the 2 forms.||||0.8581
71148129|NCT00929695|141790256|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||t-test, 2 sided|||||||0.08
71148130|NCT00929695|141790256|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||t-test, 2 sided|||||||0.4
71148131|NCT00929695|141790264|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43|||||TWO_SIDED|95.0|0.14|1.33||||||||1.33|0.14|
71148132|NCT00929695|141790265|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29||||0.009|TWO_SIDED|95.0|0.12|0.74|||Regression, Cox|||||0.74|0.12|0.009
71148133|NCT00929695|141790267|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.95|TWO_SIDED|95.0|0.6|1.74|||Regression, Cox|||||1.74|0.6|0.95
71148134|NCT05465317|141790284|OTHER||Hazard Ratio (HR)|0.75|||<|0.001|TWO_SIDED|95.0|0.65|0.86|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.86|0.65|<0.001
71148135|NCT05465317|141790284|OTHER||Hazard Ratio (HR)|0.67||||0.001|TWO_SIDED|95.0|0.52|0.86|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.86|0.52|0.001
71148136|NCT05465317|141790284|OTHER||Hazard Ratio (HR)|0.79||||0.008|TWO_SIDED|95.0|0.67|0.94|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.94|0.67|0.008
71148137|NCT05465317|141790285|OTHER||Hazard Ratio (HR)|0.74||||0.005|TWO_SIDED|95.0|0.6|0.91|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.91|0.60|0.005
71148138|NCT05465317|141790285|OTHER||Hazard Ratio (HR)|0.61||||0.02|TWO_SIDED|95.0|0.41|0.91|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.91|0.41|0.02
71148139|NCT05465317|141790285|OTHER||Hazard Ratio (HR)|0.8||||0.08|TWO_SIDED|95.0|0.63|1.03|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.03|0.63|0.08
71148140|NCT05465317|141790286|OTHER||Hazard Ratio (HR)|0.68||||0.05|TWO_SIDED|95.0|0.46|1.0|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.00|0.46|0.05
71148141|NCT05465317|141790286|OTHER||Hazard Ratio (HR)|0.61||||0.09|TWO_SIDED|95.0|0.35|1.09|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.09|0.35|0.09
71148142|NCT05465317|141790286|OTHER||Hazard Ratio (HR)|0.75||||0.3|TWO_SIDED|95.0|0.43|1.29|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.29|0.43|0.30
71148143|NCT05465317|141790287|OTHER||Hazard Ratio (HR)|0.73||||0.11|TWO_SIDED|95.0|0.49|1.08|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.08|0.49|0.11
71148144|NCT05465317|141790287|OTHER||Hazard Ratio (HR)|0.63||||0.12|TWO_SIDED|95.0|0.35|1.12|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.12|0.35|0.12
71148145|NCT05465317|141790287|OTHER||Hazard Ratio (HR)|0.84||||0.52|TWO_SIDED|95.0|0.5|1.42|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.42|0.50|0.52
71148146|NCT05465317|141790289|OTHER||Hazard Ratio (HR)|0.84||||0.02|TWO_SIDED|95.0|0.72|0.97|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.97|0.72|0.02
71148147|NCT05465317|141790289|OTHER||Hazard Ratio (HR)|0.82||||0.12|TWO_SIDED|95.0|0.65|1.05|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.05|0.65|0.12
71148148|NCT05465317|141790289|OTHER||Hazard Ratio (HR)|0.85||||0.1|TWO_SIDED|95.0|0.7|1.03|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.03|0.70|0.10
71148149|NCT05465317|141790290|OTHER||Hazard Ratio (HR)|0.9||||0.32|TWO_SIDED|95.0|0.72|1.11|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.11|0.72|0.32
71148150|NCT05465317|141790290|OTHER||Hazard Ratio (HR)|0.9||||0.5|TWO_SIDED|95.0|0.65|1.24|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.24|0.65|0.50
70875439|NCT02320149|141234975|SUPERIORITY||Least Squares Mean Difference|-12.5|||<|0.0001||95.0|-16.9|-8.0||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 9||-8.0|-16.9|< 0.0001
71148151|NCT05465317|141790290|OTHER||Hazard Ratio (HR)|0.91||||0.5|TWO_SIDED|95.0|0.68|1.2|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.20|0.68|0.50
71148152|NCT05465317|141790291|OTHER||Hazard Ratio (HR)|0.75||||0.005|TWO_SIDED|95.0|0.62|0.92|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.92|0.62|0.005
70875440|NCT02320149|141234976|SUPERIORITY||Least Squares Mean Difference|-13.3|||<|0.0001|TWO_SIDED|95.0|-17.5|-9.1||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 6||-9.1|-17.5|< 0.0001
71148153|NCT05465317|141790291|OTHER||Hazard Ratio (HR)|0.69||||0.03|TWO_SIDED|95.0|0.49|0.96|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.96|0.49|0.03
71148154|NCT05465317|141790291|OTHER||Hazard Ratio (HR)|0.8||||0.074|TWO_SIDED|95.0|0.63|1.02|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.02|0.63|0.074
71148155|NCT05465317|141790292|OTHER||Hazard Ratio (HR)|1.03||||0.46|TWO_SIDED|95.0|0.95|1.12|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.12|0.95|0.46
71148156|NCT05465317|141790292|OTHER||Hazard Ratio (HR)|1.04||||0.63|TWO_SIDED|95.0|0.9|1.2|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.20|0.90|0.63
71148157|NCT05465317|141790292|OTHER||Hazard Ratio (HR)|1.03||||0.52|TWO_SIDED|95.0|0.94|1.14|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.14|0.94|0.52
71148158|NCT05465317|141790293|OTHER||Hazard Ratio (HR)|0.81||||0.007|TWO_SIDED|95.0|0.7|0.94|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.94|0.70|0.007
71148159|NCT05465317|141790293|OTHER||Hazard Ratio (HR)|0.74||||0.03|TWO_SIDED|95.0|0.57|0.97|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.97|0.57|0.03
71148160|NCT05465317|141790293|OTHER||Hazard Ratio (HR)|0.85||||0.1|TWO_SIDED|95.0|0.71|1.03|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.03|0.71|0.10
71148161|NCT05465317|141790294|OTHER||Hazard Ratio (HR)|1.37||||0.15|TWO_SIDED|95.0|0.89|2.1|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.10|0.89|0.15
71148162|NCT05465317|141790294|OTHER||Hazard Ratio (HR)|1.05||||0.93|TWO_SIDED|95.0|0.4|2.72|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.72|0.40|0.93
71148163|NCT05465317|141790294|OTHER||Hazard Ratio (HR)|1.47||||0.113|TWO_SIDED|95.0|0.91|2.38|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.38|0.91|0.113
71148164|NCT05465317|141790295|OTHER||Hazard Ratio (HR)|0.9||||0.43|TWO_SIDED|95.0|0.71|1.16|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.16|0.71|0.43
71148165|NCT05465317|141790295|OTHER||Hazard Ratio (HR)|0.8||||0.32|TWO_SIDED|95.0|0.51|1.24|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.24|0.51|0.32
71148166|NCT05465317|141790295|OTHER||Hazard Ratio (HR)|0.96||||0.81|TWO_SIDED|95.0|0.71|1.3|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.30|0.71|0.81
71148167|NCT05465317|141790296|OTHER||Hazard Ratio (HR)|0.93||||0.69|TWO_SIDED|95.0|0.65|1.33|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.33|0.65|0.69
71148168|NCT05465317|141790296|OTHER||Hazard Ratio (HR)|0.93||||0.82|TWO_SIDED|95.0|0.51|1.7|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.70|0.51|0.82
71148169|NCT05465317|141790296|OTHER||Hazard Ratio (HR)|0.93||||0.76|TWO_SIDED|95.0|0.6|1.45|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.45|0.60|0.76
71148170|NCT05465317|141790297|OTHER||Hazard Ratio (HR)|0.68||||0.39|TWO_SIDED|95.0|0.29|1.62|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.62|0.29|0.39
71148171|NCT05465317|141790297|OTHER||Hazard Ratio (HR)|0.46||||0.34|TWO_SIDED|95.0|0.09|2.27|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.27|0.09|0.34
71148172|NCT05465317|141790297|OTHER||Hazard Ratio (HR)|0.82||||0.72|TWO_SIDED|95.0|0.29|2.33|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.33|0.29|0.72
71148173|NCT05465317|141790298|OTHER||Hazard Ratio (HR)|0.84||||0.62|TWO_SIDED|95.0|0.43|1.66|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.66|0.43|0.62
71148174|NCT05465317|141790298|OTHER||Hazard Ratio (HR)|0.59||||0.31|TWO_SIDED|95.0|0.21|1.64|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.64|0.21|0.31
71148175|NCT05465317|141790298|OTHER||Hazard Ratio (HR)|1.16||||0.76|TWO_SIDED|95.0|0.46|2.92|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.92|0.46|0.76
71148176|NCT05465317|141790299|OTHER||Hazard Ratio (HR)|1.72|||<|0.001|TWO_SIDED|95.0|1.58|1.88|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.88|1.58|<0.001
71148177|NCT05465317|141790299|OTHER||Hazard Ratio (HR)|1.84|||<|0.001|TWO_SIDED|95.0|1.48|2.3|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.30|1.48|<0.001
71148178|NCT05465317|141790299|OTHER||Hazard Ratio (HR)|1.7|||<|0.001|TWO_SIDED|95.0|1.54|1.87|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.87|1.54|<0.001
71148179|NCT00817843|141790327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.295||0.766||95.0|||||ANOVA|||"Between treatment difference in the change in FMD from the fasting to the post-fat load state.~Null hypothesis was that combination therapy (simvastatin/ezetimibe) would protect the FMD in the post-fat load phase and would therefore be associated with a smaller drop in FMD~Power calculation was based on the results from a pilot study. To detect a 1.0% difference between treatments with a SD of 2.7% and a power of 90% (alfa 0.05, two tailed) 80 evaluable patients were needed."||||0.766
71148180|NCT03755934|141790328|SUPERIORITY||LS mean estimate|-1.96|STANDARD_ERROR_OF_MEAN|0.961||0.0437|TWO_SIDED|95.0|-3.87|-0.06||ANCOVA by dose using NRS baseline value and co-medication as covariates, with CFB to Week 12 (LOCF) as dependent variable was used to derive p-value.|ANCOVA|||||-0.06|-3.87|0.0437
71148181|NCT03755934|141790328|SUPERIORITY||LS mean estimate|0.72|STANDARD_ERROR_OF_MEAN|0.541||0.1878|TWO_SIDED|95.0|-0.36|1.79||ANCOVA by dose using NRS baseline value and co-medication as covariates, with CFB to Week 12 (LOCF) as dependent variable was used to derive p-value.|ANCOVA|||||1.79|-0.36|0.1878
71148182|NCT03755934|141790328|SUPERIORITY||LS mean estimate|-1.39|STANDARD_ERROR_OF_MEAN|0.407||0.0009|TWO_SIDED|95.0|-2.19|-0.58||ANCOVA by dose using NRS baseline value and co-medication as covariates, with CFB to Week 12 (LOCF) as dependent variable was used to derive p-value.|ANCOVA|||||-0.58|-2.19|0.0009
71148183|NCT00307801|141790351|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||inverting 2 one-sided tests|||||||< 0.0001
70875441|NCT02320149|141234977|SUPERIORITY||Least Squares Mean Difference|-7.2||||0.0003|TWO_SIDED|95.0|-11.1|-3.3||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 3||-3.3|-11.1|0.0003
70875442|NCT02320149|141234978|SUPERIORITY||Least Squares Mean Difference|-3.9|||<|0.0001|TWO_SIDED|95.0|-5.3|-2.5||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 9||-2.5|-5.3|< 0.0001
70875443|NCT02320149|141234979|SUPERIORITY||Least Squares Mean Difference|-4.1|||<|0.0001|TWO_SIDED|95.0|-5.4|-2.9||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 6||-2.9|-5.4|< 0.0001
70875444|NCT02320149|141234980|SUPERIORITY||Least Squares Mean Difference|-2.1||||0.0005|TWO_SIDED|95.0|-3.3|-0.9||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 3||-0.9|-3.3|0.0005
70875445|NCT02320149|141234981|SUPERIORITY||Least Squares Mean Difference|-4.3||||0.5786|TWO_SIDED|95.0|-19.4|10.8||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 12||10.8|-19.4|0.5786
70875446|NCT02320149|141234982|SUPERIORITY||Least Squares Mean Difference|-2.8||||0.6969|TWO_SIDED|95.0|-17.1|11.4||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 9||11.4|-17.1|0.6969
70875447|NCT02320149|141234983|SUPERIORITY||Least Squares Mean Difference|3.0||||0.7377|TWO_SIDED|95.0|-14.7|20.7||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 6||20.7|-14.7|0.7377
70875448|NCT02320149|141234984|SUPERIORITY||Least Squares Mean Difference|6.4||||0.2861|TWO_SIDED|95.0|-5.3|18.1||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 3||18.1|-5.3|0.2861
70875449|NCT02320149|141234985|SUPERIORITY||Least Squares Mean Difference|-3.9||||0.0014|TWO_SIDED|95.0|-6.3|-1.5||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 12||-1.5|-6.3|0.0014
70875450|NCT02320149|141234986|SUPERIORITY||Least Squares Mean Difference|-3.4||||0.001|TWO_SIDED|95.0|-5.5|-1.4||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 9||-1.4|-5.5|0.0010
70875451|NCT02320149|141234987|SUPERIORITY||Least Squares Mean Difference|-2.0||||0.0371|TWO_SIDED|95.0|-4.0|-0.1||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 6||-0.1|-4.0|0.0371
70875452|NCT02320149|141234988|SUPERIORITY||Least Squares Mean Difference|-0.8||||0.3806|TWO_SIDED|95.0|-2.5|1.0||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 3||1.0|-2.5|0.3806
70875453|NCT01156311|141235000|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.17|-0.33|||Wilcoxon signed rank test||based on Hodges-Lehmann estimate|Change from average of Weeks -8, -4, and 0 to average of Weeks 16, 20, 24 MRI scans.||-0.33|-1.17|<0.0001
70875454|NCT01156311|141235000|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.17||||0.0124|TWO_SIDED|95.0|-1.83|-0.33|||Wilcoxon signed rank test||based on Hodges-Lehmann estimate|Change from average of Weeks -8, -4, and 0 to average of Weeks 16, 20, 24 MRI scans.||-0.33|-1.83|0.0124
71148184|NCT03431259|141790405|SUPERIORITY|||||||0.0574|||||||Chi-squared|||||||.0574
71148185|NCT03431259|141790405|SUPERIORITY|||||||0.57|||||||Chi-squared|||||||0.570
71148186|NCT00551642|141790410|OTHER||Odds Ratio (OR)|1.05||||0.734|TWO_SIDED||||||Wald Chi-square|||||||0.7340
71148187|NCT00198822|141790425|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.65||||0.05|ONE_SIDED|95.0||0.99||We set an a priori level of statistical significance of p equal to 0.05.|generalized estimating equations|RR with 95% CIs were estimated by GEE binomial regression, with a log link function and exchangeable correlation appropriate for binary data.|The vitamin A group and the Beta-carotene group were compared to the placebo group.|Sample size was based on an expected placebo group MR of 600/100,000 pregnancies, requiring 18,000 pregnancies to detect a 35% reduction in all-cause mortality, with a 5% type I error, 80% power, 1.21 design effect, 15% early pregnancy loss and 10% loss to follow-up. A mid-study DSMB analysis suggested a lower MR, leading the SS to be increased to 67,740. However, with no mortality difference evident at a DSMB meeting in Dec 2006, the trial was halted leaving 59,721 in the trial cohort.||0.99||0.05
71148188|NCT02072668|141790443|SUPERIORITY|||||||0.6281|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.6281
71148189|NCT02072668|141790444|SUPERIORITY|||||||0.7973|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.7973
71148190|NCT02072668|141790445|SUPERIORITY|||||||0.4442|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.4442
71148191|NCT02072668|141790446|SUPERIORITY|||||||0.2545|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.2545
71148192|NCT02072668|141790452|SUPERIORITY|||||||0.4374|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.4374
71148193|NCT02072668|141790453|SUPERIORITY|||||||0.347|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.3470
71148194|NCT02072668|141790454|SUPERIORITY|||||||0.0755|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.0755
71148195|NCT02072668|141790456|SUPERIORITY|||||||0.0708|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.0708
71148196|NCT02072668|141790457|SUPERIORITY|||||||0.4501|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.4501
71148197|NCT02072668|141790458|SUPERIORITY|||||||0.0767|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.0767
71148198|NCT02072668|141790459|SUPERIORITY|||||||0.725|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.7250
71148199|NCT00905164|141790535|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS mean (test/ref x 100)|99.5|||||TWO_SIDED|90.0|94.27|105.03|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125|||105.03|94.27|
71148200|NCT00905164|141790536|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS mean (test/ref x 100)|100.13||||||90.0|97.6|102.72|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.72|97.60|
70875455|NCT01156311|141235001|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.5||||0.001|TWO_SIDED|95.0|-1.5|-0.25|||Wilcoxon signed rank test||based on Hodges-Lehmann estimate|Change from average of Weeks -4, and 0 to average of Weeks 20, 24 MRI scans.||-0.25|-1.50|0.0010
71148201|NCT00905164|141790537|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (test/ref x 100)|101.53||||||90.0|99.01|104.12|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.12|99.01|
71148202|NCT05366738|141790557|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval for the geometric mean ratio between the test treatments (20 mg sprinkle capsule, either sprinkled on pudding or on applesauce) and the reference treatment (20 mg tablet) were wholly contained within 80.00% and 125.00% for the vonoprazan PK parameters.|Ratio of Geometric Least Square Means|103.36|||||TWO_SIDED|90.0|97.64|109.41||||||||109.41|97.64|
71148203|NCT05366738|141790557|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval for the geometric mean ratio between the test treatments (20 mg sprinkle capsule, either sprinkled on pudding or on applesauce) and the reference treatment (20 mg tablet) were wholly contained within 80.00% and 125.00% for the vonoprazan PK parameters.|Ratio of Geometric Least Square Means|97.83|||||TWO_SIDED|90.0|92.42|103.56||||||||103.56|92.42|
71148204|NCT05366738|141790558|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval for the geometric mean ratio between the test treatments (20 mg sprinkle capsule, either sprinkled on pudding or on applesauce) and the reference treatment (20 mg tablet) were wholly contained within 80.00% and 125.00% for the vonoprazan PK parameters.|Ratio of Geometric Least Square Means|102.56|||||TWO_SIDED|90.0|97.25|108.15||||||||108.15|97.25|
70875456|NCT01156311|141235001|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.5||||0.0339|TWO_SIDED|95.0|-1.25|0.0|||Wilcoxon signed rank test||based on Hodges-Lehmann estimate|Change from average of Weeks -4, and 0 to average of Weeks 20, 24 MRI scans.||0.00|-1.25|0.0339
71148205|NCT05366738|141790558|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval for the geometric mean ratio between the test treatments (20 mg sprinkle capsule, either sprinkled on pudding or on applesauce) and the reference treatment (20 mg tablet) were wholly contained within 80.00% and 125.00% for the vonoprazan PK parameters.|Ratio of Geometric Least Square Means|97.61|||||TWO_SIDED|90.0|92.55|102.93||||||||102.93|92.55|
71148206|NCT05366738|141790559|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval for the geometric mean ratio between the test treatments (20 mg sprinkle capsule, either sprinkled on pudding or on applesauce) and the reference treatment (20 mg tablet) were wholly contained within 80.00% and 125.00% for the vonoprazan PK parameters.|Ratio of Geometric Least Square Means|103.96|||||TWO_SIDED|90.0|96.49|112.0||||||||112.00|96.49|
71148207|NCT05366738|141790559|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval for the geometric mean ratio between the test treatments (20 mg sprinkle capsule, either sprinkled on pudding or on applesauce) and the reference treatment (20 mg tablet) were wholly contained within 80.00% and 125.00% for the vonoprazan PK parameters.|Ratio of Geometric Least Square Means|100.6|||||TWO_SIDED|90.0|93.38|108.39||||||||108.39|93.38|
71148208|NCT01389596|141790566|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.092||0.2577|TWO_SIDED|95.0|-0.29|0.08|||ANCOVA|||Linear Model With Log transformed baseline seizure rate as continuous covariate and geographic regions, treatment groups and weight as fixed effects.||0.08|-0.29|0.2577
71148209|NCT01389596|141790566|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.094||0.0185|TWO_SIDED|95.0|-0.41|-0.04|||ANCOVA|||Linear Model With Log transformed baseline seizure rate as continuous covariate and geographic regions, treatment groups and weight as fixed effects.||-0.04|-0.41|0.0185
71148210|NCT01389596|141790567|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.036||||0.8024|TWO_SIDED|95.0|0.528|2.03|||Regression, Logistic|||P-values were from a Logistic Regression Model including fixed effects for treatment, weight group, and geographical region.||2.030|0.528|0.8024
71148211|NCT01389596|141790567|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.636||||0.0092|TWO_SIDED|95.0|0.851|3.147|||Regression, Logistic|||P-values were from a Logistic Regression Model including fixed effects for treatment, weight group, and geographical region.||3.147|0.851|0.0092
70875457|NCT01741701|141235003|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.50
70875458|NCT01741701|141235004|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||t-test, 2 sided|||Comparison of change between groups from baseline to 4 months||||0.51
71148212|NCT00565084|141790592|SUPERIORITY_OR_OTHER||Difference in LS Means|0.06||||0.743||90.0|-0.23|0.35|||ANOVA|||Primary efficacy endpoint was assessed by an ANOVA model with terms for treatment, period, sequence, and patients within sequence. Efficacy advantage over placebo was assessed via the treatment difference in the least-squares (LS) means (ibuprofen vs. average of the 2 placebo treatments) from the ANOVA model and the 90% confidence interval (CI; one-sided alpha=0.05) of the LS mean difference will be assessed.||0.35|-0.23|0.743
71148213|NCT03841604|141790599|SUPERIORITY||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.52||0.1695|TWO_SIDED|95.0|-1.75|0.32|||Mixed Model Repeated Measures|||||0.32|-1.75|0.1695
70875459|NCT01741701|141235005|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||t-test, 2 sided|||Comparison between groups in the change from baseline to 4 months||||0.97
70875460|NCT01741701|141235006|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||t-test, 2 sided|||Comparison between groups in the change from baseline to 4 months||||.77
71148214|NCT03841604|141790600|OTHER||Least square mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.55||0.0784|TWO_SIDED|95.0|-2.1|0.12|||Mixed Model Repeated Measures|||||0.12|-2.1|0.0784
71148215|NCT03841604|141790601|OTHER||Risk Difference (RD)|-0.23||||0.0744|TWO_SIDED|95.0|-0.45|-0.01|||Cochran-Mantel-Haenszel|||||-0.01|-0.45|0.0744
71148216|NCT03841604|141790602|OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7247|TWO_SIDED|95.0|-0.7|0.49|||Mixed Model Repeated Measures|||||0.49|-0.70|0.7247
71148217|NCT03841604|141790603|OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.9052|TWO_SIDED|95.0|-0.43|0.38|||Mixed Model Repeated Measures|||||0.38|-0.43|0.9052
71148218|NCT03841604|141790604|OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.37||0.7115|TWO_SIDED|95.0|-0.61|0.88|||Mixed Model Repeated Measures|||||0.88|-0.61|0.7115
71148219|NCT03841604|141790605|SUPERIORITY||Risk Difference (RD)|0.04||||0.1967|TWO_SIDED|95.0|-0.04|0.12|||Cochran-Mantel-Haenszel|||||0.12|-0.04|0.1967
70875461|NCT01741701|141235007|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||t-test, 2 sided|||Comparison between groups in change from baseline to 4 months||||.90
70875462|NCT01741701|141235008|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||t-test, 2 sided|||Comparison between groups in change from baseline to 4 months||||.95
70955975|NCT00548262|141415199|SUPERIORITY_OR_OTHER||percentage of participants with success|54.1|||||TWO_SIDED|95.0|38.0|70.1|||||95% CI based on normal approximation to the binomial.|Dialysis (No): Success||70.1|38.0|
70955976|NCT00548262|141415199|SUPERIORITY_OR_OTHER||percentage of participants with success|42.1|||||TWO_SIDED|95.0|19.9|64.3|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (Yes): Success||64.3|19.9|
70875463|NCT01669915|141235015|SUPERIORITY||Mean Difference (Net)|0.01||||0.31|TWO_SIDED|95.0|-0.01|0.02|||Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in vitamin D active group minus the rate in placebo group). A mixed model included terms for the variables time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||0.02|-0.01|0.31
70955977|NCT00548262|141415199|SUPERIORITY_OR_OTHER||percentage of participants with success|52.0|||||TWO_SIDED|95.0|32.4|71.6|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (No): Success||71.6|32.4|
71148220|NCT03841604|141790606|SUPERIORITY||Risk Difference (RD)|0.06||||0.5122|TWO_SIDED|95.0|-0.13|0.26|||Cochran-Mantel-Haenszel|||||0.26|-0.13|0.5122
71148221|NCT03841604|141790608|OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|1.29||0.7376|TWO_SIDED|95.0|-3.03|2.16|||ANCOVA|||||2.16|-3.03|0.7376
71148222|NCT03841604|141790609|OTHER||Mean Difference (Net)|-2.5|STANDARD_ERROR_OF_MEAN|3.92||0.5349|TWO_SIDED|95.0|-10.33|5.43|||Mixed Model Repeated Measures|||||5.43|-10.33|0.5349
71148223|NCT01774721|141790655|SUPERIORITY||Hazard Ratio (HR)|0.589|||<|0.0001|TWO_SIDED|95.0|0.469|0.739|||1-sided stratified log-rank test||Based on stratified Cox regression model|||0.739|0.469|<0.0001
71148224|NCT01774721|141790656|SUPERIORITY||Hazard Ratio (HR)|0.748||||0.0077|TWO_SIDED|95.0|0.591|0.947|||1-sided stratified log-rank test||Based on stratified Cox Regression model|||0.947|0.591|0.0077
71148225|NCT01774721|141790658|SUPERIORITY||Hazard Ratio (HR)|0.622|||<|0.0001|TWO_SIDED|95.0|0.497|0.779|||1-sided stratified log-rank test||Based on stratified Cox regression model|||0.779|0.497|<0.0001
71148226|NCT01774721|141790661|SUPERIORITY||Hazard Ratio (HR)|0.403|||<|0.0001|TWO_SIDED|95.0|0.307|0.529|||1-sided stratified log-rank test||Based on stratified Cox regression model|Comparison of dacomitinib vs gefitinib based on IRC review||0.529|0.307|<0.0001
71148227|NCT01774721|141790661|SUPERIORITY||Hazard Ratio (HR)|0.545|||<|0.0001|TWO_SIDED|95.0|0.418|0.711|||1-sided stratified log-rank test||Based on stratified Cox regression model|Comparison of dacomitinib vs gefitinib based on Investigator assessment||0.711|0.418|<0.0001
71148228|NCT01774721|141790662|SUPERIORITY|||||||0.1942|||||||Cochran-Mantel-Haenszel|||||||0.1942
71148229|NCT01774721|141790663|SUPERIORITY|||||||0.0924|||||||Cochran-Mantel-Haenszel|||||||0.0924
71148230|NCT01774721|141790670|SUPERIORITY||Cox Proportional Hazard|1.173||||0.1641|TWO_SIDED|95.0|0.928|1.483|||Unstratified Log-rank Test|||||1.483|0.928|0.1641
71148231|NCT03594110|141790680|SUPERIORITY|"Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin.~Two-sided significance level of \<0.0017 required at interim analysis."|Hazard Ratio (HR)|0.72|||<|0.0001|TWO_SIDED|99.83|0.59|0.89|||Regression, Cox||Comparison vs. Placebo|Hazard ratio (HR) of the time to first occurrence of kidney disease progression or CV death. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening Urine albumin-to-creatinine ratio (UACR), region and treatment.||0.89|0.59|<0.0001
71148232|NCT03594110|141790681|SUPERIORITY|"Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin.~Two-sided significance level of \<0.0145 required at interim analysis."|Hazard Ratio (HR)|0.84||||0.1363|TWO_SIDED|98.55|0.63|1.12|||Regression, Cox||Comparison vs. Placebo|Hazard ratio (HR) of the time to first hospitalization for heart failure or cardiovascular death. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening Urine albumin-to-creatinine ratio (UACR), region and treatment.||1.12|0.63|0.1363
71148233|NCT03594110|141790682|SUPERIORITY|Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin. Two-sided significance level of \<0.0097 required at interim analysis.|Hazard Ratio (HR)|0.86||||0.0022|TWO_SIDED|99.03|0.76|0.98|||Joint frailty model||Comparison vs. Placebo|Hazard ratio (HR) of the time to occurrences of all-cause hospitalizations (first and recurrent combined). HR based on an analysis of recurrent events accounting for terminal events using a joint frailty model with terms for age, log(local screening UACR), local screening Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), treatment, sex, screening diabetes status, region.||0.98|0.76|0.0022
71148234|NCT03594110|141790683|SUPERIORITY|"Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin.~Two-sided significance level of \<0.0290 required at interim analysis."|Hazard Ratio (HR)|0.87||||0.2122|TWO_SIDED|97.1|0.68|1.11|||Regression, Cox||Comparison vs. Placebo|Hazard ratio (HR) of the time to death from any cause. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening Urine albumin-to-creatinine ratio (UACR), region and treatment.||1.11|0.68|0.2122
71148235|NCT03594110|141790684|SUPERIORITY|Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.62|0.81|||Regression, Cox||Comparison vs. Placebo|Hazard ratio (HR) of the time to first occurrence of kidney disease progression. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening urine albumin-to-creatinine ratio (UACR), region and treatment.||0.81|0.62|<0.0001
71148236|NCT03594110|141790685|SUPERIORITY|Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.83||||0.2932|TWO_SIDED|95.0|0.59|1.17|||Regression, Cox||Comparison vs. Placebo|Hazard ratio (HR) of the time to cardiovascular death. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening urine albumin-to-creatinine ratio (UACR), region and treatment.||1.17|0.59|0.2932
71148237|NCT03594110|141790686|SUPERIORITY|Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.72||||0.0017|TWO_SIDED|95.0|0.59|0.89|||Regression, Cox||Comparison vs. Placebo|Hazard ratio (HR) of the time to first occurrence cardiovascular death or end stage kidney disease (ESKD). HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening urine albumin-to-creatinine ratio (UACR), region and treatment.||0.89|0.59|0.0017
70875464|NCT01669915|141235015|SUPERIORITY||Mean Difference (Net)|-0.01||||0.14|TWO_SIDED|95.0|-0.02|0.003|||Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in omega-3 fatty acids active group minus the rate in placebo group). A mixed model included the variables, time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||0.003|-0.02|0.14
70875465|NCT01669915|141235016|SUPERIORITY||Mean Difference (Net)|0.01||||0.49|TWO_SIDED|95.0|-0.01|0.03||Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).|Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in vitamin D active group minus the rate in placebo group). A mixed model included the variables, time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||0.03|-0.01|0.49
70875466|NCT01669915|141235016|SUPERIORITY||Mean Difference (Net)|-0.02||||0.03|TWO_SIDED|95.0|-0.04|-0.002||Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).|Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in omega-3 active group minus the rate in placebo group). A mixed model included the variables, time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||-0.002|-0.04|0.03
70875467|NCT01669915|141235017|SUPERIORITY||Mean Difference (Net)|0.01||||0.23|TWO_SIDED|95.0|-0.01|0.02||Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).|Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in vitamin D active group minus the rate in placebo group). A mixed model included terms for the variables time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||0.02|-0.01|0.23
70875468|NCT01669915|141235017|SUPERIORITY||Mean Difference (Net)|0.003||||0.68|TWO_SIDED|95.0|-0.01|0.02||Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).|Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in omega-3 active group minus the rate in placebo group). A mixed model included terms for the variables time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization)||0.02|-0.01|0.68
70875469|NCT01669915|141235018|SUPERIORITY||Mean Difference (Net)|0.03||||0.46|TWO_SIDED|95.0|-0.04|0.09||Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).|Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in vitamin D active group minus the rate in placebo group). A mixed model included the variables, time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||0.09|-0.04|0.46
71148238|NCT03594110|141790687|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.72|0.87|||||Comparison vs. Placebo|Hazard ratio (HR) of the time to first occurrence of kidney disease progression or CV death. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening Urine albumin-to-creatinine ratio (UACR), region and treatment.||0.87|0.72|
71148239|NCT03594110|141790688|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.72|0.87|||||Comparison vs. Placebo|Hazard ratio (HR) of the time to first occurrence of kidney disease progression. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening urine albumin-to-creatinine ratio (UACR), region and treatment.||0.87|0.72|
71148240|NCT03594110|141790689|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.72|0.9|||||Comparison vs. Placebo|Hazard ratio (HR) of the time to first occurrence of death from any cause or ESKD. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening urine albumin-to-creatinine ratio (UACR), region and treatment.||0.90|0.72|
71148241|NCT03594110|141790690|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.64|0.87|||||Comparison vs. Placebo|Hazard ratio (HR) of ESKD. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening urine albumin-to-creatinine ratio (UACR), region and treatment.||0.87|0.64|
71148242|NCT03594110|141790691|OTHER||Mean Difference (Net)|-0.24|||<|0.001|TWO_SIDED|95.0|-0.38|-0.11|||Mixed Models Analysis||\[Comparator\] - \[Placebo\]|A mixed model of repeated measures (MMRM) with terms for baseline, age, sex, screening diabetes status, local screening eGFR, local screening UACR, treatment, treatment-by-time interaction and baseline-by-time interaction.||-0.11|-0.38|< 0.001
71148243|NCT03594110|141790692|OTHER||Mean Difference (Net)|-12.0||||0.41|TWO_SIDED|95.0|-42.0|17.0|||Regression, Linear||\[Comparator\]-\[Placebo\]|Differences in MRI measurements between treatment groups were assessed using a linear regression with terms for age, sex, screening diabetes status, local screening eGFR, local screening UACR was used in the analysis.||17|-42|0.41
71148244|NCT00684021|141790717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|2.0||0.959|TWO_SIDED|95.0|-4.1|3.9|||t-test, 2 sided|Stem cell treatment arm combined (Day 3 and Day7); placebo group also combined.||||3.9|-4.1|0.959
71148245|NCT00684021|141790718|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96||||0.93|TWO_SIDED|95.0|0.42|2.23|||Fisher Exact|||Clinical and Safety Outcomes including death, reinfarction, repeat revascularization, hospitalization for heart failure and ICD placement. The relative incidences of events are compared between the active and placebo groups.However the paucity of events precluded a reliable time to event analysis.||2.23|0.42|0.93
71148246|NCT00684021|141790719|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|4.8||0.585|TWO_SIDED|95.0|-12.2|6.9|||Regression, Linear|||Day 3 Stem Cell Arm and Day 7 Stem Cell Arm were combined and compared to the combination of Day 3 Placebo and Day 7 Placebo arms.||6.9|-12.2|0.585
71148247|NCT00684021|141790720|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|3.7||0.831|TWO_SIDED|95.0|-6.6|8.2|||Regression, Linear|||Day 3 Stem Cell Arm and Day 7 Stem Cell Arm were combined and compared to the combination of Day 3 Placebo and Day 7 Placebo arms.||8.2|-6.6|0.831
71148248|NCT00684021|141790721|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|3.7||0.817|TWO_SIDED|95.0|-5.5|7.0|||Regression, Linear|||Day 3 Stem Cell Arm and Day 7 Stem Cell Arm were combined and compared to the combination of Day 3 Placebo and Day 7 Placebo arms.||7.0|-5.5|0.817
71148249|NCT00684021|141790722|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7|STANDARD_ERROR_OF_MEAN|4.27||0.272|TWO_SIDED|95.0|-13.7|3.67|||Regression, Linear|||Day 3 Stem Cell Arm and Day 7 Stem Cell Arm were combined and compared to the combination of Day 3 Placebo and Day 7 Placebo arms.||3.67|-13.7|0.272
71148250|NCT00684021|141790723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|1.1||0.409|TWO_SIDED|95.0|-3.0|1.2|||t-test, 2 sided|Stem cell treatment arm combined (Day 3 and Day7); placebo group also combined.||||1.2|-3.0|0.409
71148251|NCT00684021|141790723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|100.0|STANDARD_ERROR_OF_MEAN|0.01||0.02|TWO_SIDED|95.0|15.0|1000.0|||Regression, Linear|||||1000|15|0.02
71148252|NCT00684021|141790724|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|1.7||0.777|TWO_SIDED|95.0|-3.9|2.9|||t-test, 2 sided|Stem cell treatment arm combined (Day 3 and Day7); placebo group also combined.||||2.9|-3.9|0.777
71148253|NCT01208207|141790744|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The etoricoxib dose (90 mg) will be considered non-inferior to naproxen 1000 mg if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in the least squares (LS) mean (etoricoxib minus naproxen 1000 mg) is no larger than 8 mm VAS (non-inferiority margin).|Difference in Least Squares Mean|-0.64|||||TWO_SIDED|95.0|-5.47|4.19|||ANCOVA|||||4.19|-5.47|
71148254|NCT01208207|141790745|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The etoricoxib dose (60 mg) will be considered non-inferior to naproxen 1000 mg if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in the LS mean (etoricoxib minus naproxen 1000 mg) is no larger than 8 mm VAS (non-inferiority margin).|Difference in Least Squares Mean|1.59|||||TWO_SIDED|95.0|-2.19|5.37|||ANCOVA|||||5.37|-2.19|
71148255|NCT01208207|141790746|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-1.58||||0.396|TWO_SIDED|80.0|-3.96|0.81|||ANCOVA|||||0.81|-3.96|0.396
71148256|NCT01208207|141790747|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-2.7||||0.112||80.0|-4.88|-0.52|||ANCOVA|||||-0.52|-4.88|0.112
71148257|NCT01598532|141790760|SUPERIORITY_OR_OTHER||||||<|0.004|||||||ANOVA|Univariate, one-way, repeated measure ANOVA with trend analysis||linear trend over time for the effect of LED treatments||||<0.004
71148258|NCT01598532|141790761|SUPERIORITY_OR_OTHER||||||<|0.003|||||||ANOVA|Univariate, one-way, repeated measure ANOVA with trend analysis||linear trend over time for the effect of LED treatments||||<0.003
71148259|NCT01598532|141790762|SUPERIORITY_OR_OTHER||||||<|0.003|||||||ANOVA|Univariate, one-way, repeated measure ANOVA with trend analysis||linear trend over time for effect of LED treatments||||<0.003
71148260|NCT01598532|141790763|SUPERIORITY_OR_OTHER||||||<|0.006|||||||ANOVA|Univariate, one-way, repeated measure ANOVA with trend analysis||linear trend over time for the effects of LED treatments||||<0.006
71148261|NCT01867671|141790807|SUPERIORITY||Odds Ratio (OR)|205.45|||<|0.0001|TWO_SIDED|95.0|24.0|1758.51|||Regression, Logistic|||||1758.51|24.00|<0.0001
71148262|NCT01867671|141790808|SUPERIORITY||Odds Ratio (OR)|27.82|||<|0.0031|TWO_SIDED|95.0|3.07|252.33|||Regression, Logistic|||||252.33|3.07|<0.0031
71148263|NCT01867671|141790809|OTHER|McNemar's Test|Simple Kappa Coefficient|0.162|||<|0.0001|TWO_SIDED|95.0|0.0628|0.2612|||McNemar|||||0.2612|0.0628|<0.0001
71148264|NCT01867671|141790810|SUPERIORITY||Mean Difference (Final Values)|1464.0|||<|0.0001|TWO_SIDED|95.0|944.0|1985.0|||Chi-squared|||||1985|944|<0.0001
71148265|NCT01523366|141790812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-167.2|STANDARD_ERROR_OF_MEAN|14.6|<|0.001|TWO_SIDED|95.0|-197.0|-137.4|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|||-137.4|-197.0|<.001
71148266|NCT01523366|141790813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-135.2|STANDARD_ERROR_OF_MEAN|18.23|<|0.001|TWO_SIDED|95.0|-172.3|-98.0|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus Clopidogrel|Analysis at 0.5 hours after the loading dose||-98.0|-172.3|<.001
71148267|NCT01523366|141790813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-168.9|STANDARD_ERROR_OF_MEAN|17.28|<|0.001|TWO_SIDED|95.0|-204.0|-133.7|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus Clopidogrel|Analysis at 8 hours after the loading dose||-133.7|-204.0|<.001
71148268|NCT01523366|141790814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-150.5|STANDARD_ERROR_OF_MEAN|12.97|<|0.001|TWO_SIDED|95.0|-176.9|-124.1|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus Clopidogrel|Analysis at 2 hours on Day 7 after multiple doses||-124.1|-176.9|<.001
71148269|NCT01523366|141790814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-140.2|STANDARD_ERROR_OF_MEAN|13.84|<|0.001|TWO_SIDED|95.0|-168.4|-111.9|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel.|Analysis at 8 hours on Day 7 after multiple doses||-111.9|-168.4|<.001
71148270|NCT01523366|141790814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-130.6|STANDARD_ERROR_OF_MEAN|13.41|<|0.001|TWO_SIDED|95.0|-158.0|-103.2|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel.|Analysis at end of dosing interval on Day 8||-103.2|-158.0|<.001
71148271|NCT01352715|141790838|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Confidence interval estimation was stratified by randomization stratification factors using Greenwood's variance with the inverse of this variance used for the stratum weights. The pre-specified upper confidence bound for non-inferiority was 10 percentage points.|Cumulative probability difference|-3.4|||||TWO_SIDED|95.0|-8.4|1.5||||||Treatment comparison was made using the difference (arm A - arm B) in the stratified Kaplan-Meier estimate for the week 48 cumulative probability of virologic failure with 95% confidence interval.||1.5|-8.4|
71148272|NCT04109547|141790905|SUPERIORITY||Treatment difference|-1.5|||<|0.0001|TWO_SIDED|95.0|-1.8|-1.3||Unadjusted two-sided p-value for test of no difference from 0.|MMRM|||||-1.3|-1.8|<0.0001
71148273|NCT04109547|141790905|SUPERIORITY||Treatment difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.2||Unadjusted two-sided p-value for test of no difference from 0.|MMRM|||||-1.2|-1.6|<0.0001
71148274|NCT04109547|141790905|SUPERIORITY||Treatment difference|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||Unadjusted two-sided p-value for test of no difference from 0.|MMRM|||||-0.8|-1.2|<0.0001
71148275|NCT01656408|141790971|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|3.8||0.978|TWO_SIDED|90.0|-6.4|6.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||6.6|-6.4|0.978
71148276|NCT01656408|141790971|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.9|STANDARD_ERROR_OF_MEAN|3.2||0.005|TWO_SIDED|90.0|-15.4|-4.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-4.5|-15.4|0.005
71148277|NCT01656408|141790971|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.1|STANDARD_ERROR_OF_MEAN|3.3||0|TWO_SIDED|90.0|-19.8|-8.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-8.4|-19.8|0.000
71148278|NCT01656408|141790971|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.4|STANDARD_ERROR_OF_MEAN|3.2||0.03|TWO_SIDED|90.0|-13.0|-1.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-1.9|-13.0|0.030
71148279|NCT01656408|141790971|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|4.9||0.484|TWO_SIDED|90.0|-4.9|11.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||11.9|-4.9|0.484
71148280|NCT01656408|141790971|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|3.0||0.169|TWO_SIDED|90.0|-9.3|0.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||0.9|-9.3|0.169
71148281|NCT01656408|141790971|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.7|STANDARD_ERROR_OF_MEAN|3.6||0.023|TWO_SIDED|90.0|-14.9|-2.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||-2.6|-14.9|0.023
71148282|NCT01656408|141790971|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|4.6||0.605|TWO_SIDED|90.0|-10.4|5.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||5.5|-10.4|0.605
71148283|NCT01656408|141790972|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|3.9||0.635|TWO_SIDED|90.0|-4.9|8.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||8.7|-4.9|0.635
71148284|NCT01656408|141790972|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|2.8||0.077|TWO_SIDED|90.0|-10.1|-0.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-0.4|-10.1|0.077
71148285|NCT01656408|141790972|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.4|STANDARD_ERROR_OF_MEAN|2.7||0.001|TWO_SIDED|90.0|-15.0|-5.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-5.7|-15.0|0.001
71148286|NCT01656408|141790972|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|3.5||0.556|TWO_SIDED|90.0|-8.0|3.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||3.9|-8.0|0.556
71148287|NCT01656408|141790972|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|2.3||0.527|TWO_SIDED|90.0|-5.5|2.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||2.5|-5.5|0.527
70875470|NCT01669915|141235018|SUPERIORITY||Mean Difference (Net)|-0.1||||0.003|TWO_SIDED|95.0|-0.17|-0.04||Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).|Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in omega-3 active group minus the rate in placebo group). A mixed model included the variables, time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||-0.04|-0.17|0.003
70875471|NCT00372112|141235021|SUPERIORITY||Mean Difference (Net)|2.11|||||TWO_SIDED|95.0|-3.48|7.7||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 1.||7.70|-3.48|
70875472|NCT00372112|141235021|SUPERIORITY||Mean Difference (Net)|5.33|||||TWO_SIDED|95.0|-0.41|11.07||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 1.||11.07|-0.41|
70875473|NCT00372112|141235021|SUPERIORITY||Mean Difference (Net)|2.49|||||TWO_SIDED|95.0|-3.35|8.33||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 1.||8.33|-3.35|
70875474|NCT00372112|141235021|SUPERIORITY||Mean Difference (Net)|-0.38|||||TWO_SIDED|95.0|-6.11|5.36||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 2.||5.36|-6.11|
70875475|NCT00372112|141235021|SUPERIORITY||Mean Difference (Net)|4.36|||||TWO_SIDED|95.0|-1.57|10.29||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 2.||10.29|-1.57|
70875476|NCT00372112|141235021|SUPERIORITY||Mean Difference (Net)|4.6|||||TWO_SIDED|95.0|-1.45|10.65||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 2.||10.65|-1.45|
70875477|NCT00372112|141235021|SUPERIORITY||Mean Difference (Net)|-4.25|||||TWO_SIDED|95.0|-10.44|1.93||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 7.||1.93|-10.44|
70875478|NCT00372112|141235021|SUPERIORITY||Mean Difference (Net)|-0.45|||||TWO_SIDED|95.0|-7.22|6.32||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 7.||6.32|-7.22|
70875479|NCT00372112|141235021|SUPERIORITY||Mean Difference (Net)|-1.46|||||TWO_SIDED|95.0|-8.25|5.33||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 7.||5.33|-8.25|
71148288|NCT01656408|141790972|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|2.8||0.234|TWO_SIDED|90.0|-8.1|1.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||1.4|-8.1|0.234
70875480|NCT00372112|141235021|SUPERIORITY||Mean Difference (Net)|0.16|||||TWO_SIDED|95.0|-5.98|6.29||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 8.||6.29|-5.98|
71148289|NCT01656408|141790972|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|2.5||0.002|TWO_SIDED|90.0|-12.7|-4.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||-4.1|-12.7|0.002
70875481|NCT00372112|141235021|SUPERIORITY||Mean Difference (Net)|8.3|||||TWO_SIDED|95.0|1.52|15.08||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 8.||15.08|1.52|
70875482|NCT00372112|141235021|SUPERIORITY||Mean Difference (Net)|3.82|||||TWO_SIDED|95.0|-2.85|10.5||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 8.||10.50|-2.85|
70875483|NCT00372112|141235021|SUPERIORITY||Mean Difference (Net)|-1.09|||||TWO_SIDED|95.0|-7.16|4.97||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 14.||4.97|-7.16|
71148290|NCT01656408|141790972|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|3.1||0.726|TWO_SIDED|90.0|-4.2|6.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||6.5|-4.2|0.726
71148291|NCT01656408|141790973|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|4.5||0.855|TWO_SIDED|90.0|-9.0|7.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||7.3|-9.0|0.855
71148292|NCT01656408|141790973|SUPERIORITY_OR_OTHER||LS Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|8.1||0.658|TWO_SIDED|90.0|-10.8|18.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 6||18.1|-10.8|0.658
70875484|NCT00372112|141235021|SUPERIORITY||Mean Difference (Net)|6.78|||||TWO_SIDED|95.0|-0.11|13.66||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 14.||13.66|-0.11|
70875485|NCT00372112|141235021|SUPERIORITY||Mean Difference (Net)|3.29|||||TWO_SIDED|95.0|-3.58|10.15||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 14.||10.15|-3.58|
70875486|NCT00372112|141235021|SUPERIORITY||Mean Difference (Net)|-1.12|||||TWO_SIDED|95.0|-7.64|5.4||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 15.||5.40|-7.64|
70875487|NCT00372112|141235021|SUPERIORITY||Mean Difference (Net)|3.59|||||TWO_SIDED|95.0|-3.71|10.89||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 15.||10.89|-3.71|
70875488|NCT00372112|141235021|SUPERIORITY||Mean Difference (Net)|2.11|||||TWO_SIDED|95.0|-4.96|9.18||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 15.||9.18|-4.96|
70875489|NCT00372112|141235023|SUPERIORITY||Mean Difference (Net)|2.1|||||TWO_SIDED|95.0|-7.7|12.0||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 1.||12.0|-7.7|
70875490|NCT00372112|141235023|SUPERIORITY||Mean Difference (Net)|3.0|||||TWO_SIDED|95.0|-7.2|13.1||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 1.||13.1|-7.2|
70875491|NCT00372112|141235023|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-10.2|10.1||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 1.||10.1|-10.2|
70875492|NCT00372112|141235023|SUPERIORITY||Mean Difference (Net)|2.2|||||TWO_SIDED|95.0|-6.1|10.4||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 2.||10.4|-6.1|
70875493|NCT00372112|141235023|SUPERIORITY||Mean Difference (Net)|5.8|||||TWO_SIDED|95.0|-2.8|14.3||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 2.||14.3|-2.8|
70875494|NCT00372112|141235023|SUPERIORITY||Mean Difference (Net)|1.6|||||TWO_SIDED|95.0|-6.9|10.1||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 2.||10.1|-6.9|
71148293|NCT01656408|141790973|SUPERIORITY_OR_OTHER||LS Mean Difference|6.3|STANDARD_ERROR_OF_MEAN|7.1||0.392|TWO_SIDED|90.0|-6.3|18.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||18.9|-6.3|0.392
71148294|NCT01656408|141790974|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|2.5||0.563|TWO_SIDED|90.0|-6.0|3.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||3.0|-6.0|0.563
71148295|NCT01656408|141790974|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.9||0.381|TWO_SIDED|90.0|-0.8|2.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 6||2.5|-0.8|0.381
71148296|NCT01656408|141790974|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|2.0||0.387|TWO_SIDED|90.0|-1.7|5.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||5.2|-1.7|0.387
71148297|NCT01656408|141790975|SUPERIORITY_OR_OTHER||LS Mean Difference|4.5|STANDARD_ERROR_OF_MEAN|4.7||0.357|TWO_SIDED|90.0|-3.9|12.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||12.8|-3.9|0.357
71148298|NCT01656408|141790975|SUPERIORITY_OR_OTHER||LS Mean Difference|7.4|STANDARD_ERROR_OF_MEAN|4.8||0.15|TWO_SIDED|90.0|-1.2|15.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 6||15.9|-1.2|0.150
71148299|NCT01656408|141790975|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|5.2||0.578|TWO_SIDED|90.0|-6.3|12.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||12.3|-6.3|0.578
71148300|NCT01656408|141790976|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|3.0||0.942|TWO_SIDED|90.0|-5.1|5.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||5.5|-5.1|0.942
71148301|NCT01656408|141790976|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|3.7||0.627|TWO_SIDED|90.0|-4.8|8.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 6||8.5|-4.8|0.627
71148302|NCT01656408|141790976|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3|STANDARD_ERROR_OF_MEAN|1.9||0.046|TWO_SIDED|90.0|0.9|7.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||7.6|0.9|0.046
71148303|NCT01656408|141790977|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.8|STANDARD_ERROR_OF_MEAN|3.8||0.025|TWO_SIDED|90.0|-18.0|-3.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-3.6|-18.0|0.025
71148304|NCT01656408|141790977|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|2.6||0.055|TWO_SIDED|90.0|-11.0|-1.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||-1.1|-11.0|0.055
71148305|NCT01656408|141790978|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|2.6||0.999|TWO_SIDED|90.0|-4.4|4.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||4.4|-4.4|0.999
71148306|NCT01656408|141790978|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|3.2||0.934|TWO_SIDED|90.0|-5.7|5.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 8||5.2|-5.7|0.934
71148307|NCT01656408|141790978|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|3.4||0.547|TWO_SIDED|90.0|-3.7|7.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||7.9|-3.7|0.547
71148308|NCT01656408|141790978|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|2.9||0.906|TWO_SIDED|90.0|-5.2|4.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 22||4.5|-5.2|0.906
71148309|NCT01656408|141790978|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|3.1||0.682|TWO_SIDED|90.0|-4.0|6.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||6.6|-4.0|0.682
71148310|NCT01656408|141790979|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.6|STANDARD_ERROR_OF_MEAN|2.8||0.099|TWO_SIDED|90.0|-11.1|0.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||0.0|-11.1|0.099
70875495|NCT00372112|141235023|SUPERIORITY||Mean Difference (Net)|-4.9|||||TWO_SIDED|95.0|-16.1|6.2||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 7.||6.2|-16.1|
71148311|NCT01656408|141790979|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|2.1||0.034|TWO_SIDED|90.0|-10.1|-1.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||-1.7|-10.1|0.034
71148312|NCT01656408|141790980|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|2.0||0.281|TWO_SIDED|90.0|-6.5|1.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||1.6|-6.5|0.281
71148313|NCT01656408|141790980|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|1.3||0.333|TWO_SIDED|90.0|-1.2|4.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||4.0|-1.2|0.333
71148314|NCT01656408|141790981|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|3.4||0.279|TWO_SIDED|90.0|-9.7|2.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||2.1|-9.7|0.279
71148315|NCT01656408|141790981|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|3.4||0.817|TWO_SIDED|90.0|-6.9|5.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||5.2|-6.9|0.817
71148316|NCT01656408|141790982|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|2.4||0.756|TWO_SIDED|90.0|-3.2|4.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||4.7|-3.2|0.756
71148317|NCT01656408|141790982|SUPERIORITY_OR_OTHER||LS Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|2.8||0.158|TWO_SIDED|90.0|-0.7|8.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 8||8.6|-0.7|0.158
71148318|NCT01656408|141790982|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|2.8||0.404|TWO_SIDED|90.0|-2.4|7.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||7.1|-2.4|0.404
71148319|NCT01656408|141790982|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|2.4||0.214|TWO_SIDED|90.0|-1.0|7.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 22||7.1|-1.0|0.214
71148320|NCT01656408|141790982|SUPERIORITY_OR_OTHER||LS Mean Difference|5.1|STANDARD_ERROR_OF_MEAN|2.9||0.086|TWO_SIDED|90.0|0.2|10.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||10.0|0.2|0.086
71148321|NCT01656408|141790983|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.3|STANDARD_ERROR_OF_MEAN|3.1||0.003|TWO_SIDED|90.0|-16.8|-5.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-5.9|-16.8|0.003
71148322|NCT01656408|141790983|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|3.5||0.105|TWO_SIDED|90.0|-12.3|0.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||0.1|-12.3|0.105
71148323|NCT01656408|141790984|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|3.6||0.691|TWO_SIDED|90.0|-7.5|4.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||4.6|-7.5|0.691
71148324|NCT01656408|141790984|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2|STANDARD_ERROR_OF_MEAN|3.9||0.57|TWO_SIDED|90.0|-4.3|8.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 8||8.8|-4.3|0.570
71148325|NCT01656408|141790984|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|3.4||0.666|TWO_SIDED|90.0|-4.2|7.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||7.1|-4.2|0.666
71148326|NCT01656408|141790984|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|4.7||0.534|TWO_SIDED|90.0|-10.9|4.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 22||4.9|-10.9|0.534
71148327|NCT01656408|141790984|SUPERIORITY_OR_OTHER||LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|4.0||0.528|TWO_SIDED|90.0|-4.1|9.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||9.2|-4.1|0.528
71148328|NCT01656408|141791009|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|2.0||0.848|TWO_SIDED|90.0|-3.8|3.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||3.0|-3.8|0.848
71148329|NCT01656408|141791009|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|90.0|-8.0|-4.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-4.0|-8.0|<0.0001
71148330|NCT01656408|141791009|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|3.5||0.025|TWO_SIDED|90.0|-14.4|-2.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-2.4|-14.4|0.025
71148331|NCT01656408|141791009|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|1.8||0.044|TWO_SIDED|90.0|-7.0|-0.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-0.8|-7.0|0.044
71148332|NCT01656408|141791009|SUPERIORITY_OR_OTHER||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|2.0||0.139|TWO_SIDED|90.0|-0.4|6.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||6.6|-0.4|0.139
71148333|NCT01656408|141791009|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|2.5||0.088|TWO_SIDED|90.0|-8.9|-0.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||-0.2|-8.9|0.088
71148334|NCT01656408|141791009|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|2.2||0.023|TWO_SIDED|90.0|-9.3|-1.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||-1.6|-9.3|0.023
71148335|NCT01656408|141791009|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|2.4||0.878|TWO_SIDED|90.0|-4.5|3.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||3.8|-4.5|0.878
71148336|NCT01656408|141791010|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2|STANDARD_ERROR_OF_MEAN|3.2||0.512|TWO_SIDED|90.0|-3.4|7.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.7|-3.4|0.512
71148337|NCT01656408|141791010|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|3.0||0.429|TWO_SIDED|90.0|-7.5|2.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.7|-7.5|0.429
71148338|NCT01656408|141791010|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|2.9||0.166|TWO_SIDED|90.0|-9.3|0.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||0.8|-9.3|0.166
71148339|NCT01656408|141791010|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|3.8||0.591|TWO_SIDED|90.0|-8.6|4.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||4.5|-8.6|0.591
71148340|NCT01656408|141791011|SUPERIORITY_OR_OTHER||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|4.7||0.248|TWO_SIDED|90.0|-2.5|13.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||13.5|-2.5|0.248
70875496|NCT00372112|141235023|SUPERIORITY||Mean Difference (Net)|-1.9|||||TWO_SIDED|95.0|-14.0|10.2||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 7.||10.2|-14.0|
71148341|NCT01656408|141791011|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|2.9||0.836|TWO_SIDED|90.0|-5.6|4.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||4.4|-5.6|0.836
71148342|NCT01656408|141791011|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|3.2||0.109|TWO_SIDED|90.0|-10.7|0.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||0.1|-10.7|0.109
70875497|NCT00372112|141235023|SUPERIORITY||Mean Difference (Net)|-4.8|||||TWO_SIDED|95.0|-17.1|7.5||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 7.||7.5|-17.1|
70875498|NCT00372112|141235023|SUPERIORITY||Mean Difference (Net)|3.4|||||TWO_SIDED|95.0|-4.1|10.9||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 8.||10.9|-4.1|
70875499|NCT00372112|141235023|SUPERIORITY||Mean Difference (Net)|10.8|||||TWO_SIDED|95.0|2.6|19.0||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 8.||19.0|2.6|
70875500|NCT00372112|141235023|SUPERIORITY||Mean Difference (Net)|3.1|||||TWO_SIDED|95.0|-5.2|11.4||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 8.||11.4|-5.2|
71148343|NCT01656408|141791011|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|3.7||0.785|TWO_SIDED|90.0|-5.4|7.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.5|-5.4|0.785
71148344|NCT01656408|141791012|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|3.2||0.365|TWO_SIDED|90.0|-2.5|8.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||8.3|-2.5|0.365
70875501|NCT00372112|141235023|SUPERIORITY||Mean Difference (Net)|-7.2|||||TWO_SIDED|95.0|-17.0|2.7||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 14.||2.7|-17.0|
70875502|NCT00372112|141235023|SUPERIORITY||Mean Difference (Net)|5.4|||||TWO_SIDED|95.0|-6.0|16.8||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 14.||16.8|-6.0|
70875503|NCT00372112|141235023|SUPERIORITY||Mean Difference (Net)|-2.9|||||TWO_SIDED|95.0|-13.8|8.0||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 14.||8.0|-13.8|
70875504|NCT00372112|141235023|SUPERIORITY||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-7.8|8.3||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 15.||8.3|-7.8|
70875505|NCT00372112|141235023|SUPERIORITY||Mean Difference (Net)|6.8|||||TWO_SIDED|95.0|-2.1|15.6||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 15.||15.6|-2.1|
70875506|NCT00372112|141235023|SUPERIORITY||Mean Difference (Net)|4.4|||||TWO_SIDED|95.0|-4.5|13.3||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 15.||13.3|-4.5|
70875507|NCT00372112|141235038|SUPERIORITY||Mean Difference (Net)|0.1131|||||TWO_SIDED|95.0|-0.0031|0.2293|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for FEV1 over 22-24 h at Day 1.||0.2293|-0.0031|
70875508|NCT00372112|141235038|SUPERIORITY||Mean Difference (Net)|0.159|||||TWO_SIDED|95.0|0.0408|0.2771|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for FEV1 over 22-24 h at Day 1.||0.2771|0.0408|
70875509|NCT00372112|141235038|SUPERIORITY||Mean Difference (Net)|0.0764|||||TWO_SIDED|95.0|-0.0375|0.1903|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for FEV1 over 22-24 h at Day 1.||0.1903|-0.0375|
70875510|NCT00372112|141235038|SUPERIORITY||Mean Difference (Net)|0.1741|||||TWO_SIDED|95.0|0.0178|0.3305|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for FEV1 over 22-24 h at Day 7.||0.3305|0.0178|
70875511|NCT00372112|141235038|SUPERIORITY||Mean Difference (Net)|0.1713|||||TWO_SIDED|95.0|0.006|0.3365|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for FEV1 over 22-24 h at Day 7.||0.3365|0.0060|
70875512|NCT00372112|141235038|SUPERIORITY||Mean Difference (Net)|0.1377|||||TWO_SIDED|95.0|-0.0233|0.2987|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for FEV1 over 22-24 h at Day 7.||0.2987|-0.0233|
70875513|NCT00372112|141235038|SUPERIORITY||Mean Difference (Net)|0.139|||||TWO_SIDED|95.0|-0.0266|0.3046|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for FEV1 over 22-24 h at Day 14.||0.3046|-0.0266|
70875514|NCT00372112|141235038|SUPERIORITY||Mean Difference (Net)|0.1906|||||TWO_SIDED|95.0|0.0177|0.3635|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for FEV1 over 22-24 h at Day 14.||0.3635|0.0177|
71148345|NCT01656408|141791012|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|2.9||0.424|TWO_SIDED|90.0|-7.4|2.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.6|-7.4|0.424
71148346|NCT01656408|141791012|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|3.2||0.025|TWO_SIDED|90.0|-13.3|-2.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.2|-13.3|0.025
71148347|NCT01656408|141791012|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|3.1||0.475|TWO_SIDED|90.0|-7.5|3.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.0|-7.5|0.475
71148348|NCT01656408|141791013|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|3.4||0.715|TWO_SIDED|90.0|-7.4|4.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||4.8|-7.4|0.715
71148349|NCT01656408|141791013|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|4.3||0.338|TWO_SIDED|90.0|-11.9|3.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 6||3.4|-11.9|0.338
71148350|NCT01656408|141791013|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|3.4||0.281|TWO_SIDED|90.0|-10.0|2.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||2.3|-10.0|0.281
71148351|NCT01656408|141791014|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|2.8||0.317|TWO_SIDED|90.0|-2.1|7.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.9|-2.1|0.317
71148352|NCT01656408|141791015|SUPERIORITY_OR_OTHER||LS Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|3.6||0.09|TWO_SIDED|90.0|0.2|13.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||13.2|0.2|0.090
71148353|NCT01656408|141791016|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|2.0||0.128|TWO_SIDED|90.0|-0.3|6.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||6.8|-0.3|0.128
71148354|NCT01656408|141791017|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|3.1||0.477|TWO_SIDED|90.0|-7.9|3.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||3.3|-7.9|0.477
71148355|NCT01656408|141791017|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.6|STANDARD_ERROR_OF_MEAN|3.0||0.09|TWO_SIDED|90.0|-11.0|-0.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 6||-0.2|-11.0|0.090
71148356|NCT01656408|141791017|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|3.0||0.028|TWO_SIDED|90.0|-13.0|-2.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||-2.2|-13.0|0.028
71148357|NCT01656408|141791018|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|2.5||0.877|TWO_SIDED|90.0|-4.9|4.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||4.1|-4.9|0.877
71148358|NCT01656408|141791019|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|4.6||0.827|TWO_SIDED|90.0|-9.3|7.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.2|-9.3|0.827
71148359|NCT01656408|141791020|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|3.5||0.161|TWO_SIDED|90.0|-11.4|1.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.0|-11.4|0.161
71148360|NCT01656408|141791021|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.5|STANDARD_ERROR_OF_MEAN|4.4||0.046|TWO_SIDED|90.0|-18.8|-2.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-2.3|-18.8|0.046
70875515|NCT00372112|141235038|SUPERIORITY||Mean Difference (Net)|0.0956|||||TWO_SIDED|95.0|-0.0686|0.2599|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for FEV1 over 22-24 h at Day 14.||0.2599|-0.0686|
70875516|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.009|||||TWO_SIDED|95.0|-0.59|0.608|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 1.||0.608|-0.590|
70875517|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.237|||||TWO_SIDED|95.0|-0.354|0.829|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 1.||0.829|-0.354|
70875518|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.093|||||TWO_SIDED|95.0|-0.469|0.654|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 1.||0.654|-0.469|
70875519|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.199|||||TWO_SIDED|95.0|-0.591|0.988|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 2.||0.988|-0.591|
70875520|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.633|||||TWO_SIDED|95.0|-0.152|1.418|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 2.||1.418|-0.152|
70875521|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.065|||||TWO_SIDED|95.0|-0.667|0.797|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 2.||0.797|-0.667|
70875522|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.097|||||TWO_SIDED|95.0|-0.476|0.67|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 7.||0.670|-0.476|
70875523|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.408|||||TWO_SIDED|95.0|-0.208|1.024|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 7.||1.024|-0.208|
70875524|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-0.471|0.631|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 7.||0.631|-0.471|
70875525|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.245|||||TWO_SIDED|95.0|-0.66|1.149|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 8.||1.149|-0.660|
70875526|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.796|||||TWO_SIDED|95.0|-0.174|1.766|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 8.||1.766|-0.174|
70875527|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.144|||||TWO_SIDED|95.0|-0.742|1.03|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 8.||1.030|-0.742|
70875528|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.056|||||TWO_SIDED|95.0|-0.556|0.669|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 14.||0.669|-0.556|
70875529|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|-0.138|||||TWO_SIDED|95.0|-0.767|0.491|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 14.||0.491|-0.767|
70875530|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|-0.187|||||TWO_SIDED|95.0|-0.765|0.391|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 14.||0.391|-0.765|
70875531|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.094|||||TWO_SIDED|95.0|-0.619|0.806|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 15.||0.806|-0.619|
71148361|NCT01656408|141791021|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.9|STANDARD_ERROR_OF_MEAN|2.3||0.001|TWO_SIDED|90.0|-17.2|-8.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||-8.6|-17.2|0.001
71148362|NCT01656408|141791022|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|2.6||0.91|TWO_SIDED|90.0|-4.6|5.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||5.2|-4.6|0.910
71148363|NCT01656408|141791023|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|3.6||0.906|TWO_SIDED|90.0|-6.6|5.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||5.7|-6.6|0.906
71148364|NCT01656408|141791024|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|2.4||0.87|TWO_SIDED|90.0|-4.4|3.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.7|-4.4|0.870
71148365|NCT01656408|141791025|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|90.0|-5.0|-3.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-3.7|-5.0|<0.0001
71148366|NCT01656408|141791025|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.2|STANDARD_ERROR_OF_MEAN|1.2||0.001|TWO_SIDED|90.0|-10.7|-5.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||-5.7|-10.7|0.001
71148367|NCT01656408|141791026|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|1.0||0.038|TWO_SIDED|90.0|-4.9|-0.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.8|-4.9|0.038
71148368|NCT01656408|141791027|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.8||0.238|TWO_SIDED|90.0|-6.0|1.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.2|-6.0|0.238
70955978|NCT00548262|141415199|SUPERIORITY_OR_OTHER||percentage of participants with success|47.7|||||TWO_SIDED|95.0|33.0|62.5|||||95% CI based on normal approximation to the binomial.|Solid organ transplant (No): Success||62.5|33.0|
71148369|NCT01656408|141791028|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|1.0||0.048|TWO_SIDED|90.0|-4.7|-0.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.6|-4.7|0.048
71148370|NCT01656408|141791029|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.6||0.83|TWO_SIDED|90.0|-3.2|2.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||2.5|-3.2|0.830
71148371|NCT01656408|141791029|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|2.9||0.063|TWO_SIDED|90.0|-10.8|-0.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||-0.7|-10.8|0.063
71148372|NCT01656408|141791030|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|3.7||0.892|TWO_SIDED|90.0|-7.1|6.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||6.1|-7.1|0.892
71148373|NCT01656408|141791031|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|3.1||0.571|TWO_SIDED|90.0|-3.4|6.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||6.9|-3.4|0.571
71148374|NCT01656408|141791032|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.8||0.816|TWO_SIDED|90.0|-5.4|4.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||4.0|-5.4|0.816
71148375|NCT01656408|141791033|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|2.2||0.061|TWO_SIDED|90.0|-8.4|-0.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-0.6|-8.4|0.061
71148376|NCT01656408|141791033|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|2.6||0.161|TWO_SIDED|90.0|-8.3|0.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||0.7|-8.3|0.161
71148377|NCT01656408|141791034|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|2.0||0.786|TWO_SIDED|90.0|-4.0|2.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.9|-4.0|0.786
71148378|NCT01656408|141791035|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|3.3||0.263|TWO_SIDED|90.0|-9.3|1.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.8|-9.3|0.263
71148379|NCT01656408|141791036|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.0||0.565|TWO_SIDED|90.0|-4.4|2.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.1|-4.4|0.565
71148380|NCT03592186|141791043|SUPERIORITY|In zero-inflated distributions, two outcomes can be specified: 1) probability of being an excess zero (falling outside expected negative binomial distribution), and 2) count value, if not an excess zero. Our focal effect of interest was Time\*Condition in the count distribution, i.e. effect of condition over time on predicting the percent of days used greater than zero.|Risk Ratio (RR)|1.15|STANDARD_ERROR_OF_MEAN|2.57||0.12|TWO_SIDED|95.0|0.97|1.36|||Mixed Models Analysis|||Mixed models with zero-inflated distributions evaluated whether there was a Time\*Condition interaction, using data from the baseline, 12-week, and 24-week assessments. Full maximum likelihood estimation was used. We tested the primary outcome (percent of days of use over the past 90 days, adjusted for time in a controlled environment) for overall number of days of use.||1.36|.97|.12
71148381|NCT03592186|141791044|SUPERIORITY||Risk Ratio (RR)|-0.1|STANDARD_ERROR_OF_MEAN|0.34||0.19|TWO_SIDED|95.0|-0.34|0.07|||Mixed Models Analysis|||Mixed models using a linear distribution evaluated whether change in substance-related problems differed by condition. The focal effect was a Time\*Condition interaction, using data from the baseline, 12-week, and 24-week assessments. Full maximum likelihood estimation was used.||.07|-.34|.19
71148382|NCT03592186|141791045|SUPERIORITY||Chi-square value|0.01||||0.92|TWO_SIDED||||||Chi-squared|||Comparison of the count of positive urine screens by condition at 12 weeks||||.92
71148383|NCT01409707|141791050|SUPERIORITY_OR_OTHER||||||=|0.068||95.0||||The a priori threshold for statistical significance was set at p = .05.|Mixed Models Analysis|||Multilevel mixed modeling was employed. The null hypothesis was that there'd be no differences between groups at posttreatment on posttraumatic stress disorder measures or alcohol use measures.||||=.068
71148384|NCT01409707|141791051|SUPERIORITY_OR_OTHER||||||=|0.39||95.0||||The a priori threshold for statistical significance was set at p=.05.|Mixed Models Analysis|||Multilevel mixed modeling was employed. The null hypothesis was that there would be no differences in alcohol use at posttreatment.||||= 0.39
71148385|NCT01929317|141791075|SUPERIORITY_OR_OTHER||Mean change from Baseline|-4.8|||<|0.001|TWO_SIDED|95.0|-6.3|-3.2|||t-test, 1 sided|||||-3.2|-6.3|<0.001
71148386|NCT01929317|141791076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-2.4|2.0|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part III total score for Week 2.|||2.0|-2.4|
71148387|NCT01929317|141791076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-1.9|3.1|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part III total score for Week 4.|||3.1|-1.9|
71148388|NCT01929317|141791076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-2.3|3.0|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part III total score for Week 6.|||3.0|-2.3|
71148389|NCT01929317|141791076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-3.4|2.0|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part III total score for Week 8.|||2.0|-3.4|
71148390|NCT01929317|141791076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0|-2.0|3.9|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part III total score for Week 12.|||3.9|-2.0|
71148391|NCT01929317|141791078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.2|0.3|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 1 total score for Week 2.|||0.3|-0.2|
71148392|NCT01929317|141791078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.2|0.4|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 1 total score for Week 4.|||0.4|-0.2|
71148393|NCT01929317|141791078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.4|0.3|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 1 total score for Week 6.|||0.3|-0.4|
71148394|NCT01929317|141791078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.3|0.3|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 1 total score for Week 8.|||0.3|-0.3|
71148395|NCT01929317|141791078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.2|0.6|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 1 total score for Week 12.|||0.6|-0.2|
71148396|NCT01929317|141791079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-1.8|0.1|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 2, On status.|||0.1|-1.8|
71148397|NCT01929317|141791079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-2.4|0.1|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 4, On status.|||0.1|-2.4|
71148398|NCT01929317|141791079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-2.6|0.3|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 6, On status.|||0.3|-2.6|
71148399|NCT01929317|141791079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-2.8|0.3|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 8, On status.|||0.3|-2.8|
71148400|NCT01929317|141791079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-2.7|0.7|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 12, On status.|||0.7|-2.7|
71148401|NCT01929317|141791079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-1.8|0.5|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 2, Off status.|||0.5|-1.8|
71148402|NCT01929317|141791079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-2.6|0.8|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 4, Off status.|||0.8|-2.6|
70875532|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.358|||||TWO_SIDED|95.0|-0.39|1.105|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 15.||1.105|-0.390|
71148403|NCT01929317|141791079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-2.8|1.0|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 6, Off status.|||1.0|-2.8|
71148404|NCT01929317|141791079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-2.1|1.8|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 8, Off status.|||1.8|-2.1|
71148405|NCT01929317|141791079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-2.2|2.1|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 12, Off status.|||2.1|-2.2|
71148406|NCT01929317|141791080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.7|0.4|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 4 total score for Week 2.|||0.4|-0.7|
71148407|NCT01929317|141791080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.7|0.6|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 4 total score for Week 4.|||0.6|-0.7|
71148408|NCT01929317|141791080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.7|0.8|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 4 total score for Week 6.|||0.8|-0.7|
71148409|NCT01929317|141791080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 4 total score for Week 8.|||0.7|-0.7|
71148410|NCT01929317|141791080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.9|0.5|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 4 total score for Week 12.|||0.5|-0.9|
71148411|NCT01929317|141791093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-1.65|1.04|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent Off for Week 2."|||1.04|-1.65|
71148412|NCT01929317|141791093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|||||TWO_SIDED|95.0|-1.34|1.45|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent Off for Week 4."|||1.45|-1.34|
71148413|NCT01929317|141791093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|||||TWO_SIDED|95.0|-1.95|1.24|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent Off for Week 6."|||1.24|-1.95|
71148414|NCT01929317|141791093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|||||TWO_SIDED|95.0|-2.44|0.75|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent Off for Week 8."|||0.75|-2.44|
71148415|NCT01929317|141791093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07|||||TWO_SIDED|95.0|-2.73|0.58|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent Off for Week 12."|||0.58|-2.73|
70875533|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.178|||||TWO_SIDED|95.0|-0.522|0.877|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 15.||0.877|-0.522|
70875534|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|-0.294|||||TWO_SIDED|95.0|-0.586|-0.001|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 1.||-0.001|-0.586|
70875535|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|-0.371|||||TWO_SIDED|95.0|-0.657|-0.085|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 1.||-0.085|-0.657|
70875536|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|-0.153|||||TWO_SIDED|95.0|-0.44|0.133|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 1.||0.133|-0.440|
70875537|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|-0.216|||||TWO_SIDED|95.0|-0.679|0.247|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 2.||0.247|-0.679|
70875538|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|-0.536|||||TWO_SIDED|95.0|-0.998|-0.074|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 2.||-0.074|-0.998|
70875539|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|-0.018|||||TWO_SIDED|95.0|-0.452|0.416|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 2.||0.416|-0.452|
70875540|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|-0.486|||||TWO_SIDED|95.0|-0.878|-0.095|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 7.||-0.095|-0.878|
70875541|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|-0.562|||||TWO_SIDED|95.0|-0.99|-0.135|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 7.||-0.135|-0.990|
70875542|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|-0.19|||||TWO_SIDED|95.0|-0.575|0.196|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 7.||0.196|-0.575|
70875543|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.075|||||TWO_SIDED|95.0|-0.235|0.385|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 8.||0.385|-0.235|
70875544|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|-0.275|||||TWO_SIDED|95.0|-0.623|0.073|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 8.||0.073|-0.623|
70875545|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.103|||||TWO_SIDED|95.0|-0.213|0.418|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 8.||0.418|-0.213|
70875546|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|-0.299|||||TWO_SIDED|95.0|-0.64|0.042|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 14.||0.042|-0.640|
70875547|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|-0.271|||||TWO_SIDED|95.0|-0.621|0.079|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 14.||0.079|-0.621|
70875548|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|-0.095|||||TWO_SIDED|95.0|-0.432|0.243|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 14.||0.243|-0.432|
70875549|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.173|||||TWO_SIDED|95.0|-0.158|0.505|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 15.||0.505|-0.158|
70875550|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|-0.196|||||TWO_SIDED|95.0|-0.535|0.143|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 15.||0.143|-0.535|
70875551|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.139|||||TWO_SIDED|95.0|-0.198|0.475|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 15.||0.475|-0.198|
70875552|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|-0.14|||||TWO_SIDED|95.0|-1.18|0.9|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 1.||0.90|-1.18|
71148416|NCT01929317|141791094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03|||||TWO_SIDED|95.0|-8.77|6.71|||||"Estimated value and CI are presented for the change from Baseline in the proportion of awake time spent Off for Week 2."|||6.71|-8.77|
70875553|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.29|||||TWO_SIDED|95.0|-0.72|1.3|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 1.||1.30|-0.72|
70875554|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|-0.17|||||TWO_SIDED|95.0|-1.15|0.8|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 1.||0.80|-1.15|
70875555|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-0.64|1.44|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 2.||1.44|-0.64|
71148417|NCT01929317|141791094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-7.94|8.22|||||"Estimated value and CI are presented for the change from Baseline in the proportion of awake time spent Off for Week 4."|||8.22|-7.94|
71148418|NCT01929317|141791094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.78|||||TWO_SIDED|95.0|-12.06|6.49|||||"Estimated value and CI are presented for the change from Baseline in the proportion of awake time spent Off for Week 6."|||6.49|-12.06|
71148419|NCT01929317|141791094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.46|||||TWO_SIDED|95.0|-14.06|5.14|||||"Estimated value and CI are presented for the change from Baseline in the proportion of awake time spent Off for Week 8."|||5.14|-14.06|
71148420|NCT01929317|141791094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.98|||||TWO_SIDED|95.0|-15.92|3.96|||||"Estimated value and CI are presented for the change from Baseline in the proportion of awake time spent Off for Week 12."|||3.96|-15.92|
71148421|NCT01929317|141791095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|||||TWO_SIDED|95.0|-1.07|1.21|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On for Week 2."|||1.21|-1.07|
71148422|NCT01929317|141791095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47|||||TWO_SIDED|95.0|-0.75|1.7|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On for Week 4."|||1.70|-0.75|
71148423|NCT01929317|141791095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.65|1.86|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On for Week 6."|||1.86|-0.65|
71148424|NCT01929317|141791095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85|||||TWO_SIDED|95.0|-0.52|2.22|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On for Week 8."|||2.22|-0.52|
71148425|NCT01929317|141791095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86|||||TWO_SIDED|95.0|-0.55|2.26|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On for Week 12."|||2.26|-0.55|
71148426|NCT01929317|141791096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|||||TWO_SIDED|95.0|-0.98|1.36|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On without troublesome dyskinesias for Week 2."|||1.36|-0.98|
71148427|NCT01929317|141791096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57|||||TWO_SIDED|95.0|-0.64|1.78|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On without troublesome dyskinesias for Week 4."|||1.78|-0.64|
71148428|NCT01929317|141791096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|||||TWO_SIDED|95.0|-0.71|1.84|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On without troublesome dyskinesias for Week 6."|||1.84|-0.71|
71148429|NCT01929317|141791096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|||||TWO_SIDED|95.0|-0.47|2.39|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On without troublesome dyskinesias for Week 8."|||2.39|-0.47|
71148430|NCT01929317|141791096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85|||||TWO_SIDED|95.0|-0.63|2.33|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On without troublesome dyskinesias for Week 12."|||2.33|-0.63|
71148431|NCT04322526|141791110|OTHER|||||||0.01|||||||t-test, 2 sided|||Changes in BOLD signal in the rACC during the processing of contextual cues (pleasant \> unpleasant).||||0.01
71148432|NCT04322526|141791111|OTHER|Mechanistic hypothesis: naltrexone will block contextual processing.||||||0.0002|||||||t-test, 2 sided|||Changes in BOLD fMRI signal from the Placebo vs. the Naltrexone session.||||0.0002
71148433|NCT00935584|141791137|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.||||>0.05
71148434|NCT00935584|141791137|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.||||>0.05
71148435|NCT00935584|141791138|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis is that there is no significant change in outcome from pre to post visit.||||>0.05
71148436|NCT00935584|141791138|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wicoxon signed rank test|||The null hypothesis is that there is no significant change in outcome from pre to post visit.||||>0.05
71148437|NCT00935584|141791139|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis is that there is no significant change in patient engagement from pre to post visit.||||>0.05
71148438|NCT00935584|141791139|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no significant change in patient engagement from pre to post visit.||||>0.05
71148439|NCT00935584|141791140|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.||||<0.05
71148440|NCT00935584|141791140|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.||||<0.05
71148441|NCT00935584|141791141|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis is that there is no significant change in outcome from pre to post visit.||||<0.05
71148442|NCT00935584|141791141|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no significant change in outcome from pre to post visit.||||<0.05
71148443|NCT00935584|141791142|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.||||<0.05
71148444|NCT00935584|141791142|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.||||<0.05
71148445|NCT03863080|141791227|SUPERIORITY||Least square mean difference|-56.33|||<|0.0001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 340 mg/week of Total IgG levels has been presented.|||||<0.0001
71148446|NCT03863080|141791227|SUPERIORITY||Least square mean difference|-74.49|||<|0.0001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 680 mg/week of Total IgG levels has been presented.|||||<0.0001
71148447|NCT03863080|141791228|SUPERIORITY||Least square mean difference|-62.7|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 340 mg/week of IgG 1 subclass has been presented.|||||<0.001
71148448|NCT03863080|141791228|SUPERIORITY||Least square mean difference|-73.0|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 680 mg/week of IgG 1 subclass has been presented.|||||<0.001
71148449|NCT03863080|141791228|SUPERIORITY||Least square mean difference|-52.5|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 340 mg/week of IgG 2 subclass has been presented.|||||<0.001
71148450|NCT03863080|141791228|SUPERIORITY||Least square mean difference|-61.4|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 680 mg/week of IgG 2 subclass has been presented.|||||<0.001
71148451|NCT03863080|141791228|SUPERIORITY||Least square mean difference|-66.1|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 340 mg/week of IgG 3 subclass has been presented.|||||<0.001
71148452|NCT03863080|141791228|SUPERIORITY||Least square mean difference|-80.8|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 680 mg/week of IgG 3 subclass has been presented.|||||<0.001
71148453|NCT03863080|141791228|SUPERIORITY||Least square mean difference|-44.9|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 340 mg/week of IgG 4 subclass has been presented.|||||<0.001
71148454|NCT03863080|141791228|SUPERIORITY||Least square mean difference|-61.6|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 680 mg/week of IgG 4 subclass has been presented.|||||<0.001
71148455|NCT03863080|141791229|SUPERIORITY||Least square mean difference|-62.58||||0.0009|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 340 mg/week of Anti-AChR-IgG has been presented.|||||0.0009
71148456|NCT03863080|141791229|SUPERIORITY||Least square mean difference|-101.2|||<|0.0001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 680 mg/week of Anti-AChR-IgG has been presented.|||||<0.0001
71148457|NCT01342211|141791245|SUPERIORITY_OR_OTHER||Least squares (LS) Mean Difference|-5.63|STANDARD_ERROR_OF_MEAN|9.759||0.5661|TWO_SIDED|95.0|-25.09|13.83|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline.||13.83|-25.09|0.5661
71148458|NCT01342211|141791245|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|9.422||0.808|TWO_SIDED|95.0|-21.08|16.49|||ANCOVA|||Analysis was performed using ANCOVA model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline.||16.49|-21.08|0.8080
71148459|NCT01342211|141791245|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.72|STANDARD_ERROR_OF_MEAN|9.404||0.0001|TWO_SIDED|95.0|-56.47|-18.97|||ANCOVA|||Analysis was performed using ANCOVA model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline.||-18.97|-56.47|0.0001
71148460|NCT01342211|141791245|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.11|STANDARD_ERROR_OF_MEAN|9.514|<|0.0001|TWO_SIDED|95.0|-68.08|-30.14|||ANCOVA|||Analysis was performed using ANCOVA model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline.||-30.14|-68.08|<0.0001
71148461|NCT01342211|141791246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.172||||0.8998|TWO_SIDED|95.0|0.1|13.92|||Regression, Logistic|||Day 29, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||13.92|0.10|0.8998
71148462|NCT01342211|141791246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.063||||0.5273|TWO_SIDED|95.0|0.22|19.48|||Regression, Logistic|||Day 29, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||19.48|0.22|0.5273
71148463|NCT01342211|141791246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|53.924||||0.0004|TWO_SIDED|95.0|5.93|490.67|||Regression, Logistic|||Day 29, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||490.67|5.93|0.0004
71148464|NCT01342211|141791246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|280.366|||<|0.0001|TWO_SIDED|95.0|18.65|4214.35|||Regression, Logistic|||Day 29, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||4214.35|18.65|<0.0001
71148465|NCT01342211|141791246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.262||||0.086|TWO_SIDED|95.0|0.06|1.21|||Regression, Logistic|||Day 29, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||1.21|0.06|0.0860
71148466|NCT01342211|141791246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.579||||0.4308|TWO_SIDED|95.0|0.15|2.25|||Regression, Logistic|||Day 29, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||2.25|0.15|0.4308
71148467|NCT01342211|141791246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.272||||0.0127|TWO_SIDED|95.0|1.57|43.56|||Regression, Logistic|||Day 29, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||43.56|1.57|0.0127
71148468|NCT01342211|141791246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.528||||0.0096|TWO_SIDED|95.0|1.89|97.0|||Regression, Logistic|||Day 29, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||97.00|1.89|0.0096
71148469|NCT01342211|141791246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.131||||0.9519|TWO_SIDED|95.0|0.02|61.54|||Regression, Logistic|||Day 57, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||61.54|0.02|0.9519
71148470|NCT01342211|141791246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.069||||0.974|TWO_SIDED|95.0|0.02|58.0|||Regression, Logistic|||Day 57, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||58.00|0.02|0.9740
71148471|NCT01342211|141791246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|28.286||||0.0273|TWO_SIDED|95.0|1.46|549.78|||Regression, Logistic|||Day 57, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||549.78|1.46|0.0273
71148472|NCT01342211|141791246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|114.508||||0.0022|TWO_SIDED|95.0|5.5|2384.03|||Regression, Logistic|||Day 57, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||2384.03|5.50|0.0022
70875556|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.69|||||TWO_SIDED|95.0|-0.32|1.7|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 2.||1.70|-0.32|
71148473|NCT01342211|141791246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.216||||0.0684|TWO_SIDED|95.0|0.04|1.12|||Regression, Logistic|||Day 57, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||1.12|0.04|0.0684
71148474|NCT01342211|141791246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.081||||0.9068|TWO_SIDED|95.0|0.29|3.99|||Regression, Logistic|||Day 57, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||3.99|0.29|0.9068
71148475|NCT01342211|141791246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.251||||0.2235|TWO_SIDED|95.0|0.61|8.31|||Regression, Logistic|||Day 57, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||8.31|0.61|0.2235
71148476|NCT01342211|141791246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.25||||0.012|TWO_SIDED|95.0|1.59|42.82|||Regression, Logistic|||Day 57, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||42.82|1.59|0.0120
70875557|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.23|||||TWO_SIDED|95.0|-0.74|1.2|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 2.||1.20|-0.74|
70875558|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|-0.05|||||TWO_SIDED|95.0|-1.11|1.01|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 7.||1.01|-1.11|
71148477|NCT01342211|141791246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.359||||0.5449|TWO_SIDED|95.0|0.01|9.92|||Regression, Logistic|||Day 85, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||9.92|0.01|0.5449
71148478|NCT01342211|141791246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.914||||0.5585|TWO_SIDED|95.0|0.22|16.85|||Regression, Logistic|||Day 85, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||16.85|0.22|0.5585
71148479|NCT01342211|141791246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.059||||0.0022|TWO_SIDED|95.0|3.0|147.65|||Regression, Logistic|||Day 85, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||147.65|3.00|0.0022
70875559|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.53|||||TWO_SIDED|95.0|-0.57|1.62|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 7.||1.62|-0.57|
71148480|NCT01342211|141791246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|22.851||||0.002|TWO_SIDED|95.0|3.15|165.99|||Regression, Logistic|||Day 85, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||165.99|3.15|0.0020
71148481|NCT01342211|141791246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.844||||0.375|TWO_SIDED|95.0|0.48|7.12|||Regression, Logistic|||Day 85, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||7.12|0.48|0.3750
71148482|NCT01342211|141791246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.078||||0.914|TWO_SIDED|95.0|0.28|4.23|||Regression, Logistic|||Day 85, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||4.23|0.28|0.9140
71148483|NCT01342211|141791246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.548||||0.0036|TWO_SIDED|95.0|2.09|43.57|||Regression, Logistic|||Day 85, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||43.57|2.09|0.0036
71148484|NCT01342211|141791246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.093||||0.0149|TWO_SIDED|95.0|1.42|26.1|||Regression, Logistic|||Day 85, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||26.10|1.42|0.0149
70875560|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.13|||||TWO_SIDED|95.0|-0.89|1.15|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 7.||1.15|-0.89|
71148485|NCT01342211|141791247|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.674||||0.5436|TWO_SIDED|95.0|0.32|8.83|||Regression, Logistic|||Day 29: The standard logistic regression model was used to assess treatment effect.||8.83|0.32|0.5436
71148486|NCT01342211|141791247|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.734||||0.742|TWO_SIDED|95.0|0.12|4.63|||Regression, Logistic|||Day 29: The standard logistic regression model was used to assess treatment effect.||4.63|0.12|0.7420
71148487|NCT01342211|141791247|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|28.151||||0.0002|TWO_SIDED|95.0|4.73|167.62|||Regression, Logistic|||Day 29: The standard logistic regression model was used to assess treatment effect.||167.62|4.73|0.0002
71148488|NCT01342211|141791247|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|71.214||||0.0001|TWO_SIDED|95.0|7.88|643.42|||Regression, Logistic|||Day 29: The standard logistic regression model was used to assess treatment effect.||643.42|7.88|0.0001
71148489|NCT01342211|141791247|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.203||||0.321|TWO_SIDED|95.0|0.01|4.74|||Regression, Logistic|||Day 57: The standard logistic regression model was used to assess treatment effect.||4.74|0.01|0.3210
71148490|NCT01342211|141791247|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.175||||0.3786|TWO_SIDED|95.0|0.39|12.27|||Regression, Logistic|||Day 57: The standard logistic regression model was used to assess treatment effect.||12.27|0.39|0.3786
71148491|NCT01342211|141791247|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.576||||0.0144|TWO_SIDED|95.0|1.5|38.38|||Regression, Logistic|||Day 57: The standard logistic regression model was used to assess treatment effect.||38.38|1.50|0.0144
71148492|NCT01342211|141791247|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.465||||0.0007|TWO_SIDED|95.0|3.59|116.6|||Regression, Logistic|||Day 57: The standard logistic regression model was used to assess treatment effect.||116.60|3.59|0.0007
71148493|NCT01342211|141791247|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.161||||0.8626|TWO_SIDED|95.0|0.21|6.3|||Regression, Logistic|||Day 85: The standard logistic regression model was used to assess treatment effect.||6.30|0.21|0.8626
71148494|NCT01342211|141791247|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.497||||0.6237|TWO_SIDED|95.0|0.3|7.51|||Regression, Logistic|||Day 85: The standard logistic regression model was used to assess treatment effect.||7.51|0.30|0.6237
71148495|NCT01342211|141791247|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.029||||0.0072|TWO_SIDED|95.0|1.76|36.65|||Regression, Logistic|||Day 85: The standard logistic regression model was used to assess treatment effect.||36.65|1.76|0.0072
71148496|NCT01342211|141791247|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.557||||0.0005|TWO_SIDED|95.0|3.73|113.2|||Regression, Logistic|||Day 85: The standard logistic regression model was used to assess treatment effect.||113.20|3.73|0.0005
71148497|NCT06482125|141791257|SUPERIORITY||Odds Ratio (OR)|40.955||||0.001|TWO_SIDED|95.0|14.098|118.972|||Chi-squared, Corrected|||||118.972|14.098|0.001
71148498|NCT06482125|141791258|EQUIVALENCE|The threshold for statistical significance is p \< 0.05||||||0.345|||||||Wilcoxon (Mann-Whitney)|||||||0.345
71148499|NCT06482125|141791259|EQUIVALENCE|The threshold for statistical significance is p \< 0.05||||||0.45|||||||Wilcoxon (Mann-Whitney)|||||||0.450
71148500|NCT06482125|141791260|EQUIVALENCE|Reject H0 = the means are equivalent|Median Difference (Net)|1.0||||0.356|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.356
71148501|NCT06482125|141791261|EQUIVALENCE|Reject H0 = the means are equivalent|Mean Difference (Final Values)|8.202||||0.07|TWO_SIDED|95.0|2.31|14.095|||t-test, 2 sided|||||14.095|2.310|0.07
71148502|NCT05786651|141791301|EQUIVALENCE|Comparison of conditions|||||<|0.05|||||||ANOVA|||||||<.05
71148503|NCT05786651|141791302|EQUIVALENCE|Comparisons of mean values of conditions|||||<|0.05|||||||ANOVA|||||||<.05
71148504|NCT04390763|141791308|OTHER||Hazard Ratio (HR)|0.7|||||ONE_SIDED|90.0||1.04|||Bayesian two-piece hazard model||Estimated posterior median of the HR after the risk changing timepoint and one-sided 90% credible interval are reported.|||1.04||
71148505|NCT04390763|141791308|OTHER||Hazard Ratio (HR)|1.41|||||ONE_SIDED|90.0||1.96|||Bayesian two-piece hazard model||Estimated posterior median of the HR after the risk changing timepoint and one-sided 90% credible interval are reported.|||1.96||
71148506|NCT04390763|141791309|OTHER||Hazard Ratio (HR)|1.02||||0.46|ONE_SIDED|90.0||1.37|||Regression, Cox|||||1.37||0.46
70955979|NCT00548262|141415199|SUPERIORITY_OR_OTHER||percentage of participants with success|14.3|||||TWO_SIDED|95.0|0.0|40.2|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (Yes): Success||40.2|0.0|
71148507|NCT04390763|141791309|OTHER||Hazard Ratio (HR)|1.08||||0.38|ONE_SIDED|90.0||1.44|||Regression, Cox|||||1.44||0.38
71148508|NCT03077412|141791358|SUPERIORITY||Risk Difference in Percentages|22.1|||||TWO_SIDED|90.0|-9.9|50.0|||||The 90% exact confidence interval (CI) was calculated based on binomial distribution (Clopper-Pearson method).|||50.0|-9.9|
71148509|NCT03077412|141791358|SUPERIORITY||Risk Difference in Percentages|4.2|||||TWO_SIDED|90.0|-26.5|34.3|||||The 90% exact CI was calculated based on binomial distribution (Clopper-Pearson method).|||34.3|-26.5|
71148510|NCT03077412|141791359|SUPERIORITY||Risk Difference in Percentages|30.4|||||TWO_SIDED|90.0|-1.3|57.3|||||The 90% exact CI was calculated based on binomial distribution (Clopper-Pearson method).|||57.3|-1.3|
71148511|NCT03077412|141791359|SUPERIORITY||Risk Difference in Percentages|8.3|||||TWO_SIDED|90.0|-22.5|38.1|||||The 90% exact CI was calculated based on binomial distribution (Clopper-Pearson method).|||38.1|-22.5|
71148512|NCT03077412|141791360|SUPERIORITY||Hazard Ratio (HR)|1.26|||||TWO_SIDED|90.0|0.64|2.49|||||Hazard ratio was derived from Cox Proportional-Hazards model.|||2.49|0.64|
71148513|NCT03077412|141791360|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|90.0|0.47|1.75|||||Hazard ratio was derived from Cox Proportional-Hazards model.|||1.75|0.47|
71148514|NCT03077412|141791361|SUPERIORITY||Hazard Ratio (HR)|1.87|||||TWO_SIDED|90.0|0.87|4.01|||||Hazard ratio was derived from Cox Proportional-Hazards model.|||4.01|0.87|
71148515|NCT03077412|141791361|SUPERIORITY||Hazard Ratio (HR)|1.37|||||TWO_SIDED|90.0|0.65|2.92|||||Hazard ratio was derived from Cox Proportional-Hazards model.|||2.92|0.65|
71148516|NCT03077412|141791362|SUPERIORITY||Risk Difference in Percentages|-18.6|||||TWO_SIDED|90.0|-55.6|21.3|||||The 90% exact CI was calculated based on binomial distribution (Clopper-Pearson method).|||21.3|-55.6|
71148517|NCT03077412|141791362|SUPERIORITY||Risk Difference in Percentages|-13.2|||||TWO_SIDED|90.0|-51.0|24.1|||||The 90% exact CI was calculated based on binomial distribution (Clopper-Pearson method).|||24.1|-51.0|
71148518|NCT02266888|141791367|SUPERIORITY||Hazard Ratio (HR)|0.673||||0.514|TWO_SIDED|90.0|0.248|1.826|||Regression, Cox||Hazard ratio estimated for Rituximab vs. Placebo|||1.826|0.248|0.514
71148519|NCT02266888|141791371|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
71148520|NCT02266888|141791372|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
71148521|NCT02266888|141791373|SUPERIORITY|||||||0.188|||||||Fisher Exact|||||||0.188
70875561|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.26|||||TWO_SIDED|95.0|-0.98|1.5|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 8.||1.50|-0.98|
70875562|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.86|||||TWO_SIDED|95.0|-0.42|2.14|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 8.||2.14|-0.42|
70875563|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.32|||||TWO_SIDED|95.0|-0.9|1.54|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 8.||1.54|-0.90|
70875564|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-1.2|1.3|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 14.||1.30|-1.20|
71148522|NCT02266888|141791376|SUPERIORITY||Mean Difference (Net)|-1.62||||0.015|TWO_SIDED|90.0|-2.64|-0.6|||Paired t-Test|||This is not a comparison between treatment groups, but rather a comparison between timepoints.The Rituximab and Placebo groups were combined for purposes of testing the hypothesis that there would be no change in SD between pre-enrollment and 180 days post-enrollment into the TVI.||-0.60|-2.64|0.015
71148523|NCT02266888|141791378|SUPERIORITY|||||||0.502|||||||Cochran-Mantel-Haenszel|||||||0.502
71148524|NCT02266888|141791379|SUPERIORITY|||||||0.448|||||||Fisher Exact|||||||0.448
71148525|NCT03038100|141791408|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.2785|TWO_SIDED|95.0|0.79|1.07|||Log Rank|||||1.07|0.79|0.2785
71148526|NCT03038100|141791409|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.8||||0.0376|TWO_SIDED|95.0|0.65|0.99|||Log Rank|||||0.99|0.65|0.0376
71148527|NCT03038100|141791410|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.3432|TWO_SIDED|95.0|0.78|1.09|||Log Rank|||Stratified by: stage and/or surgical status (Stage III vs. Stage IV), ECOG performance status (0 vs. 1 or 2), tumor PD-L1 status (IC0 vs. IC1/2/3), and treatment strategy (adjuvant vs. neoadjuvant).||1.09|0.78|0.3432
71148528|NCT03038100|141791411|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.83||||0.1316|TWO_SIDED|95.0|0.66|1.06|||Log Rank|||Stratified by: stage and/or surgical status (Stage III vs. Stage IV), ECOG performance status (0 vs. 1 or 2) and treatment strategy (adjuvant vs. neoadjuvant).||1.06|0.66|0.1316
71148529|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.97||||0.9096|TWO_SIDED|95.0|0.58|1.62|||Cochran-Mantel-Haenszel|||Emotional Functioning, Presurgical/Surgery||1.62|0.58|0.9096
71148530|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.21||||0.4662|TWO_SIDED|95.0|0.73|2.01|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 4 Day 1||2.01|0.73|0.4662
70875565|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.75|||||TWO_SIDED|95.0|-0.53|2.03|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 14.||2.03|-0.53|
71148531|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.85||||0.5237|TWO_SIDED|95.0|0.51|1.4|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 6 Day 1||1.40|0.51|0.5237
71148532|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.25||||0.3826|TWO_SIDED|95.0|0.76|2.07|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 8 Day 1||2.07|0.76|0.3826
71148533|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.9893|TWO_SIDED|95.0|0.56|1.76|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 12 Day 1||1.76|0.56|0.9893
71148534|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.89||||0.6892|TWO_SIDED|95.0|0.49|1.61|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 16 Day 1||1.61|0.49|0.6892
71148535|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.59||||0.1324|TWO_SIDED|95.0|0.3|1.17|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 20 Day 1||1.17|0.30|0.1324
71148536|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.03||||0.9176|TWO_SIDED|95.0|0.62|1.7|||Cochran-Mantel-Haenszel|||Emotional Functioning, Completion of Treatment/Early Termination Visit||1.70|0.62|0.9176
71148537|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.92||||0.7861|TWO_SIDED|95.0|0.5|1.68|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 3 Months||1.68|0.50|0.7861
71148538|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.31||||0.4539|TWO_SIDED|95.0|0.65|2.65|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 6 Months||2.65|0.65|0.4539
71148539|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.71||||0.4849|TWO_SIDED|95.0|0.27|1.86|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 9 Months||1.86|0.27|0.4849
71148540|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.79||||0.747|TWO_SIDED|95.0|0.19|3.34|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 12 Months||3.34|0.19|0.7470
71148541|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|33.33||||0.0896|TWO_SIDED|95.0|-44.86|100.0|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 18 Months||100.00|-44.86|0.0896
71148542|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|50.0|||||TWO_SIDED|95.0|-94.3|100.0||||||Emotional Functioning, Post-Treatment Follow Up 24 Months||100.00|-94.30|
70875566|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-1.23|1.23|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 14.||1.23|-1.23|
71148543|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.92||||0.7347|TWO_SIDED|95.0|0.56|1.5|||Cochran-Mantel-Haenszel|||Physical Functioning, Presurgical/Surgery||1.50|0.56|0.7347
71148544|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.56||||0.0479|TWO_SIDED|95.0|0.32|1.0|||Cochran-Mantel-Haenszel|||Physical Functioning, Cycle 4 Day 1||1.00|0.32|0.0479
71148545|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.61||||0.0712|TWO_SIDED|95.0|0.36|1.05|||Cochran-Mantel-Haenszel|||Physical Functioning, Cycle 6 Day 1||1.05|0.36|0.0712
71148546|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.8168|TWO_SIDED|95.0|0.56|1.58|||Cochran-Mantel-Haenszel|||Physical Functioning, Cycle 8 Day 1||1.58|0.56|0.8168
71148547|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.88||||0.6417|TWO_SIDED|95.0|0.5|1.52|||Cochran-Mantel-Haenszel|||Physical Functioning, Cycle 12 Day 1||1.52|0.50|0.6417
71148548|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.96||||0.8821|TWO_SIDED|95.0|0.53|1.72|||Cochran-Mantel-Haenszel|||Physical Functioning, Cycle 16 Day 1||1.72|0.53|0.8821
71148549|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.64||||0.2158|TWO_SIDED|95.0|0.32|1.3|||Cochran-Mantel-Haenszel|||Physical Functioning, Cycle 20 Day 1||1.30|0.32|0.2158
71148550|NCT03038100|141791417|SUPERIORITY||Odds Ratio (OR)|0.84||||0.4762|TWO_SIDED|95.0|0.51|1.37|||Cochran-Mantel-Haenszel|||Physical Functioning, Completion of Treatment/Early Termination Visit||1.37|0.51|0.4762
71148551|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.1||||0.7585|TWO_SIDED|95.0|0.61|1.96|||Cochran-Mantel-Haenszel|||Physical Functioning, Post-Treatment Follow Up 3 Months||1.96|0.61|0.7585
71148552|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.9985|TWO_SIDED|95.0|0.52|1.93|||Cochran-Mantel-Haenszel|||Physical Functioning, Post-Treatment Follow Up 6 Months||1.93|0.52|0.9985
71148553|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.07||||0.1067|TWO_SIDED|95.0|0.85|5.06|||Cochran-Mantel-Haenszel|||Physical Functioning, Post-Treatment Follow Up 9 Months||5.06|0.85|0.1067
71148554|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.42||||0.6171|TWO_SIDED|95.0|0.36|5.61|||Cochran-Mantel-Haenszel|||Physical Functioning, Post-Treatment Follow Up 12 Months||5.61|0.36|0.6171
71148555|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.41||||0.8084|TWO_SIDED|95.0|0.08|23.57|||Cochran-Mantel-Haenszel|||Physical Functioning, Post-Treatment Follow Up 18 Months||23.57|0.08|0.8084
71148556|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|-50.0||||0.3173|TWO_SIDED|95.0|-100.0|94.3|||Cochran-Mantel-Haenszel|||Physical Functioning, Post-Treatment Follow Up 24 Months||94.30|-100.00|0.3173
71148557|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.1||||0.6802|TWO_SIDED|95.0|0.69|1.77|||Cochran-Mantel-Haenszel|||Global health status/QoL, Presurgical/Surgery||1.77|0.69|0.6802
71148558|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.79||||0.347|TWO_SIDED|95.0|0.48|1.29|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 4 Day 1||1.29|0.48|0.3470
71148559|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.86||||0.5564|TWO_SIDED|95.0|0.53|1.41|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 6 Day 1||1.41|0.53|0.5564
71148560|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.19||||0.5|TWO_SIDED|95.0|0.72|1.99|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 8 Day 1||1.99|0.72|0.5000
71148561|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.01||||0.9778|TWO_SIDED|95.0|0.57|1.78|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 12 Day 1||1.78|0.57|0.9778
71148562|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.17||||0.6005|TWO_SIDED|95.0|0.65|2.12|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 16 Day 1||2.12|0.65|0.6005
71148563|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.99|TWO_SIDED|95.0|0.5|2.0|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 20 Day 1||2.00|0.50|0.9900
71148564|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.32||||0.2634|TWO_SIDED|95.0|0.81|2.15|||Cochran-Mantel-Haenszel|||Global health status/QoL, Completion of Treatment/Early Termination Visit||2.15|0.81|0.2634
71148565|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.99||||0.964|TWO_SIDED|95.0|0.56|1.74|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 3 Months||1.74|0.56|0.9640
71148566|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.76||||0.4117|TWO_SIDED|95.0|0.4|1.46|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 6 Months||1.46|0.40|0.4117
71148567|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.51||||0.3505|TWO_SIDED|95.0|0.63|3.62|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 9 Months||3.62|0.63|0.3505
71148568|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.28||||0.2439|TWO_SIDED|95.0|0.55|9.45|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 12 Months||9.45|0.55|0.2439
71148569|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|33.33||||0.1573|TWO_SIDED|95.0|-44.86|100.0|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 18 Months||100.00|-44.86|0.1573
71148570|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|50.0|||||TWO_SIDED|95.0|-94.3|100.0||||||Global health status/QoL, Post-Treatment Follow Up 24 Months||100.00|-94.30|
71148571|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.72||||0.182|TWO_SIDED|95.0|0.45|1.16|||Cochran-Mantel-Haenszel|||Role Functioning, Presurgical/Surgery||1.16|0.45|0.1820
71148572|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.47||||0.0046|TWO_SIDED|95.0|0.28|0.8|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 4 Day 1||0.80|0.28|0.0046
71148573|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.59||||0.0361|TWO_SIDED|95.0|0.36|0.97|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 6 Day 1||0.97|0.36|0.0361
70875567|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.22|||||TWO_SIDED|95.0|-0.78|1.23|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 15.||1.23|-0.78|
70875568|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.84|||||TWO_SIDED|95.0|-0.21|1.89|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 15.||1.89|-0.21|
70875569|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.49|||||TWO_SIDED|95.0|-0.5|1.48|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 15.||1.48|-0.50|
71148574|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.64||||0.0848|TWO_SIDED|95.0|0.39|1.06|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 8 Day 1||1.06|0.39|0.0848
71148575|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.64||||0.1224|TWO_SIDED|95.0|0.37|1.13|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 12 Day 1||1.13|0.37|0.1224
71148576|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.74||||0.3127|TWO_SIDED|95.0|0.41|1.33|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 16 Day 1||1.33|0.41|0.3127
71148577|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.84||||0.6065|TWO_SIDED|95.0|0.42|1.65|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 20 Day 1||1.65|0.42|0.6065
71148578|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.74||||0.2173|TWO_SIDED|95.0|0.45|1.2|||Cochran-Mantel-Haenszel|||Role functioning, Completion of Treatment/ Early Termination Visit||1.20|0.45|0.2173
71148579|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.64||||0.1316|TWO_SIDED|95.0|0.35|1.15|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 3 Months||1.15|0.35|0.1316
71148580|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.9||||0.7678|TWO_SIDED|95.0|0.46|1.76|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 6 Months||1.76|0.46|0.7678
71148581|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.85||||0.7331|TWO_SIDED|95.0|0.34|2.14|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 9 Months||2.14|0.34|0.7331
71148582|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.83||||0.1235|TWO_SIDED|95.0|0.73|10.92|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 12 Months||10.92|0.73|0.1235
71148583|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|0.0|||||TWO_SIDED|95.0|-84.09|84.09||||||Role functioning, Post-Treatment Follow Up 18 Months||84.09|-84.09|
71148584|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|50.0|||||TWO_SIDED|95.0|-94.3|100.0||||||Role functioning, Post-Treatment Follow Up 24 Months||100.00|-94.30|
71148585|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.07||||0.7869|TWO_SIDED|95.0|0.65|1.78|||Cochran-Mantel-Haenszel|||Social functioning, Presurgical/Surgery||1.78|0.65|0.7869
71148586|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.73||||0.2502|TWO_SIDED|95.0|0.43|1.25|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 4 Day 1||1.25|0.43|0.2502
71148587|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.84||||0.5066|TWO_SIDED|95.0|0.5|1.41|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 6 Day 1||1.41|0.50|0.5066
71148588|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.8124|TWO_SIDED|95.0|0.56|1.59|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 8 Day 1||1.59|0.56|0.8124
71148589|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.23||||0.4656|TWO_SIDED|95.0|0.7|2.17|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 12 Day 1||2.17|0.70|0.4656
71148590|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.14||||0.6725|TWO_SIDED|95.0|0.62|2.12|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 16 Day 1||2.12|0.62|0.6725
71148591|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.82||||0.578|TWO_SIDED|95.0|0.41|1.64|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 20 Day 1||1.64|0.41|0.5780
71148592|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.08||||0.7611|TWO_SIDED|95.0|0.66|1.76|||Cochran-Mantel-Haenszel|||Social functioning, Completion of Treatment/Early Termination Visit||1.76|0.66|0.7611
71148593|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.09||||0.7588|TWO_SIDED|95.0|0.62|1.94|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 3 Months||1.94|0.62|0.7588
71148594|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.6||||0.1428|TWO_SIDED|95.0|0.3|1.19|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 6 Months||1.19|0.30|0.1428
71148595|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.99||||0.9802|TWO_SIDED|95.0|0.41|2.39|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 9 Months||2.39|0.41|0.9802
71148596|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.34||||0.1967|TWO_SIDED|95.0|0.63|8.7|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 12 Months||8.70|0.63|0.1967
71148597|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Difference in Proportion of Respnders|8.33||||0.4795|TWO_SIDED|95.0|-69.28|85.94|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 18 Months||85.94|-69.28|0.4795
70875570|NCT00372112|141235043|SUPERIORITY||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-0.47|0.09|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 1.||0.09|-0.47|
70875571|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|-0.22|||||TWO_SIDED|95.0|-0.49|0.04|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 1.||0.04|-0.49|
70875572|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|-0.19|||||TWO_SIDED|95.0|-0.46|0.07|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 1.||0.07|-0.46|
70875573|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.47|0.27|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 2.||0.27|-0.47|
70875574|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|-0.38|||||TWO_SIDED|95.0|-0.73|-0.03|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 2.||-0.03|-0.73|
70875575|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.37|0.34|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 2.||0.34|-0.37|
70875576|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|-0.54|||||TWO_SIDED|95.0|-0.97|-0.12|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 7.||-0.12|-0.97|
70875577|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|-0.55|||||TWO_SIDED|95.0|-0.98|-0.12|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 7.||-0.12|-0.98|
70875578|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|-0.34|||||TWO_SIDED|95.0|-0.76|0.08|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 7.||0.08|-0.76|
70875579|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.26|0.33|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 8.||0.33|-0.26|
70875580|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-0.7|-0.1|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 8.||-0.10|-0.70|
70875581|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.04|||||TWO_SIDED|95.0|-0.26|0.34|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 8.||0.34|-0.26|
70875582|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|-0.15|||||TWO_SIDED|95.0|-0.42|0.12|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 14.||0.12|-0.42|
70875583|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|-0.23|||||TWO_SIDED|95.0|-0.51|0.04|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 14.||0.04|-0.51|
71148598|NCT03038100|141791417|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|50.0|||||TWO_SIDED|95.0|-94.3|100.0||||||Social functioning, Post-Treatment Follow Up 24 Months||100.00|-94.30|
70875584|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|-0.06|||||TWO_SIDED|95.0|-0.34|0.21|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 14.||0.21|-0.34|
70875585|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-0.25|0.35|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 15.||0.35|-0.25|
71148599|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.6651|TWO_SIDED|95.0|0.7|1.25|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 3 Day 1||1.25|0.70|0.6651
71148600|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.9927|TWO_SIDED|95.0|0.75|1.34|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 5 Day 1||1.34|0.75|0.9927
71148601|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.03||||0.8209|TWO_SIDED|95.0|0.77|1.39|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 8 Day 1||1.39|0.77|0.8209
71148602|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.07||||0.6507|TWO_SIDED|95.0|0.79|1.45|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 12 Day 1||1.45|0.79|0.6507
71148603|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.21||||0.2596|TWO_SIDED|95.0|0.87|1.67|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 16 Day 1||1.67|0.87|0.2596
70875586|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|-0.35|||||TWO_SIDED|95.0|-0.66|-0.05|||Regression, Linear|||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 15.||-0.05|-0.66|
71148604|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.09||||0.6532|TWO_SIDED|95.0|0.75|1.58|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 20 Day 1||1.58|0.75|0.6532
71148605|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.05||||0.7592|TWO_SIDED|95.0|0.76|1.45|||Cochran-Mantel-Haenszel|||Emotional functioning, Completion Of Treatment/ Early Termination Visit||1.45|0.76|0.7592
71148606|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.93||||0.7424|TWO_SIDED|95.0|0.62|1.4|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 3 Months||1.40|0.62|0.7424
71148607|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.37||||0.1912|TWO_SIDED|95.0|0.85|2.19|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 6 Months||2.19|0.85|0.1912
71148608|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.83||||0.5526|TWO_SIDED|95.0|0.45|1.53|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 9 Months||1.53|0.45|0.5526
71148609|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.69||||0.3609|TWO_SIDED|95.0|0.32|1.52|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 12 Months||1.52|0.32|0.3609
71148610|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.8||||0.7527|TWO_SIDED|95.0|0.2|3.23|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 18 Months||3.23|0.20|0.7527
71148611|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|-33.33|||||TWO_SIDED|95.0|-100.0|75.44||||||Emotional functioning, Post-Treatment Follow Up 24 Months||75.44|-100.00|
71148612|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.85||||0.3177|TWO_SIDED|95.0|0.62|1.17|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 3 Day 1||1.17|0.62|0.3177
71148613|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.88||||0.4184|TWO_SIDED|95.0|0.63|1.21|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 5 Day 1||1.21|0.63|0.4184
71148614|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.91||||0.571|TWO_SIDED|95.0|0.67|1.24|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 8 Day 1||1.24|0.67|0.5710
71148615|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.88||||0.3973|TWO_SIDED|95.0|0.65|1.19|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 12 Day 1||1.19|0.65|0.3973
71148616|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.12||||0.5163|TWO_SIDED|95.0|0.8|1.55|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 16 Day 1||1.55|0.80|0.5163
71148617|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.93||||0.6897|TWO_SIDED|95.0|0.64|1.35|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 20 Day 1||1.35|0.64|0.6897
71148618|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.91||||0.5735|TWO_SIDED|95.0|0.67|1.25|||Cochran-Mantel-Haenszel|||Physical functioning, Completion Of Treatment/ Early Termination Visit||1.25|0.67|0.5735
71148619|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.75||||0.1414|TWO_SIDED|95.0|0.5|1.1|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 3 Months||1.10|0.50|0.1414
71148620|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.96||||0.8655|TWO_SIDED|95.0|0.59|1.55|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 6 Months||1.55|0.59|0.8655
71148621|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.72||||0.3017|TWO_SIDED|95.0|0.38|1.35|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 9 Months||1.35|0.38|0.3017
71148622|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.6||||0.2325|TWO_SIDED|95.0|0.26|1.39|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 12 Months||1.39|0.26|0.2325
71148623|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.33||||0.1717|TWO_SIDED|95.0|0.06|1.69|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 18 Months||1.69|0.06|0.1717
70875587|NCT00372112|141235043|SUPERIORITY||Mean Difference (Net)|0.04|||||TWO_SIDED|95.0|-0.26|0.34|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 15.||0.34|-0.26|
70875588|NCT01025791|141235058|OTHER||0.1 mg vs. placebo|-7.06||||0.003|TWO_SIDED|90.0|-11.1|-3.0|||ANOVA|||||-3.00|-11.1|0.003
70875589|NCT01025791|141235058|OTHER||0.2 mg vs. placebo|-1.23||||0.31|TWO_SIDED|90.0|-5.42|2.96|||ANOVA|||||2.96|-5.42|0.310
70875590|NCT01025791|141235058|OTHER||0.5 mg vs. placebo|0.01||||0.498|TWO_SIDED|90.0|-4.05|4.06|||ANOVA|||||4.06|-4.05|0.498
70875591|NCT01025791|141235058|OTHER||1 mg vs. placebo|-5.69||||0.012|TWO_SIDED|90.0|-9.74|-1.63|||ANOVA|||||-1.63|-9.74|0.012
71148624|NCT03038100|141791418|SUPERIORITY|Stratified Analsyis|Difference in Proportion of Responders|16.67|||||TWO_SIDED|95.0|-46.49|79.82||||||Physical functioning, Post-Treatment Follow Up 24 Months||79.82|-46.49|
71148625|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.11||||0.4745|TWO_SIDED|95.0|0.84|1.46|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 3 Day 1||1.46|0.84|0.4745
71148626|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.92||||0.5499|TWO_SIDED|95.0|0.69|1.22|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 5 Day 1||1.22|0.69|0.5499
71148627|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.97||||0.8436|TWO_SIDED|95.0|0.73|1.29|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 8 Day 1||1.29|0.73|0.8436
71148628|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.09||||0.5798|TWO_SIDED|95.0|0.81|1.46|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 12 Day 1||1.46|0.81|0.5798
71148629|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.02||||0.9094|TWO_SIDED|95.0|0.74|1.39|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 16 Day 1||1.39|0.74|0.9094
71148630|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.17||||0.4006|TWO_SIDED|95.0|0.81|1.67|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 20 Day 1||1.67|0.81|0.4006
71148631|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.88||||0.4024|TWO_SIDED|95.0|0.65|1.19|||Cochran-Mantel-Haenszel|||Global health status/QoL, Completion of Treatment/ Early Termination Visit||1.19|0.65|0.4024
71148632|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.97||||0.8796|TWO_SIDED|95.0|0.67|1.41|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 3 Months||1.41|0.67|0.8796
71148633|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.83||||0.435|TWO_SIDED|95.0|0.53|1.32|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 6 Months||1.32|0.53|0.4350
71148634|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.86||||0.6225|TWO_SIDED|95.0|0.47|1.56|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 9 Months||1.56|0.47|0.6225
71148635|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.8||||0.5775|TWO_SIDED|95.0|0.36|1.77|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 12 Months||1.77|0.36|0.5775
71148636|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.37||||0.2343|TWO_SIDED|95.0|0.07|1.94|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 18 Months||1.94|0.07|0.2343
71148637|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|-66.67||||0.0833|TWO_SIDED|95.0|-100.0|4.39|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 24 Months||4.39|-100.00|0.0833
71148638|NCT03038100|141791418|SUPERIORITY|Superiority|Odds Ratio (OR)|0.93||||0.6012|TWO_SIDED|95.0|0.71|1.21|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 3 Day 1||1.21|0.71|0.6012
71148639|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.85||||0.2291|TWO_SIDED|95.0|0.65|1.11|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 5 Day 1||1.11|0.65|0.2291
71148640|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.6574|TWO_SIDED|95.0|0.71|1.24|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 8 Day 1||1.24|0.71|0.6574
71148641|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.01||||0.9217|TWO_SIDED|95.0|0.76|1.35|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 12 Day 1||1.35|0.76|0.9217
71148642|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.95||||0.7693|TWO_SIDED|95.0|0.7|1.3|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 16 Day 1||1.30|0.70|0.7693
71148643|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.92||||0.647|TWO_SIDED|95.0|0.64|1.31|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 20 Day 1||1.31|0.64|0.6470
71148644|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.93||||0.6391|TWO_SIDED|95.0|0.7|1.25|||Cochran-Mantel-Haenszel|||Role functioning, Completion Of Treatment/ Early Termination Visit||1.25|0.70|0.6391
71148645|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.73||||0.0892|TWO_SIDED|95.0|0.51|1.05|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 3 Months||1.05|0.51|0.0892
71148646|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.65||||0.055|TWO_SIDED|95.0|0.41|1.01|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 6 Months||1.01|0.41|0.0550
71148647|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.49||||0.0168|TWO_SIDED|95.0|0.27|0.88|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 9 Months||0.88|0.27|0.0168
71148648|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.29||||0.0021|TWO_SIDED|95.0|0.13|0.65|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 12 Months||0.65|0.13|0.0021
71148649|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.8||||0.7817|TWO_SIDED|95.0|0.17|3.8|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 18 Months||3.80|0.17|0.7817
71148650|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|-33.33|||||TWO_SIDED|95.0|-100.0|75.44||||||Role functioning, Post-Treatment Follow Up 24 Months||75.44|-100.00|
71148651|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.06||||0.6646|TWO_SIDED|95.0|0.8|1.41|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 3 Day 1||1.41|0.80|0.6646
71148652|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.98||||0.8677|TWO_SIDED|95.0|0.73|1.3|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 5 Day 1||1.30|0.73|0.8677
71148653|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.04||||0.767|TWO_SIDED|95.0|0.79|1.38|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 8 Day 1||1.38|0.79|0.7670
71148654|NCT03038100|141791418|SUPERIORITY||Odds Ratio (OR)|0.95||||0.7487|TWO_SIDED|95.0|0.71|1.28|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 12 Day 1||1.28|0.71|0.7487
71148655|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.23||||0.1882|TWO_SIDED|95.0|0.9|1.68|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 16 Day 1||1.68|0.90|0.1882
70875592|NCT01025791|141235058|OTHER||1 mg + 0.8 mg vs. placebo|-3.97||||0.059|TWO_SIDED|90.0|-8.16|0.22|||ANOVA|||||0.22|-8.16|0.059
70875593|NCT01025791|141235058|OTHER||0.4 mg vs. placebo|2.22||||0.191|TWO_SIDED|90.0|-2.09|6.54|||ANOVA|||||6.54|-2.09|0.191
70875594|NCT01025791|141235058|OTHER||1.2 mg vs. placebo|1.24||||0.333|TWO_SIDED|90.0|-3.67|6.15|||ANOVA|||||6.15|-3.67|0.333
70875595|NCT01025791|141235058|OTHER||1.2 mg + 0.6 mg vs. placebo|-1.43||||0.314|TWO_SIDED|90.0|-6.5|3.63|||ANOVA|||||3.63|-6.50|0.314
70875596|NCT01025791|141235058|OTHER||1 mg + 0.8 mg vs. placebo|-9.31||||0.001|TWO_SIDED|90.0|-14.2|-4.37|||ANOVA|||||-4.37|-14.2|0.001
70875597|NCT01025791|141235058|OTHER||1.2 mg + 1.0 mg vs. placebo|-6.45||||0.017|TWO_SIDED|90.0|-11.4|-1.51|||ANOVA|||||-1.51|-11.4|0.017
70875598|NCT01025791|141235058|OTHER||1.0 mg + 0.6 mg + 0.6 mg vs. placebo|-9.96||||0.001|TWO_SIDED|90.0|-14.9|-5.02|||ANOVA|||||-5.02|-14.9|0.001
70875599|NCT01025791|141235058|OTHER||1 mg + 1 mg + 0.6 mg vs. placebo|-9.0||||0.002|TWO_SIDED|95.0|-13.8|-4.17|||ANOVA|||||-4.17|-13.8|0.002
70875600|NCT01025791|141235063|OTHER||GMR (Fed/Fasted)|0.89|||||TWO_SIDED|95.0|0.86|0.92||||||||0.92|0.86|
70875601|NCT01025791|141235064|OTHER||GMR (Fed/fasted)|0.97|||||TWO_SIDED|95.0|0.79|1.19||||||||1.19|0.79|
70875602|NCT01025791|141235065|OTHER||0.1 mg vs placebo|-0.53||||0.396|TWO_SIDED|90.0|-3.92|2.86|||ANOVA|||||2.86|-3.92|0.396
70875603|NCT01025791|141235065|OTHER||0.2 mg vs. placebo|2.33||||0.1329|TWO_SIDED|90.0|-1.17|5.83|||ANOVA|||||5.83|-1.17|0.1329
70875604|NCT01025791|141235065|OTHER||0.5mg vs. placebo|-2.96||||0.0741|TWO_SIDED|90.0|-6.35|0.43|||ANOVA|||||0.43|-6.35|0.0741
70875605|NCT01025791|141235065|OTHER||1 mg vs. placebo|7.08|||<|0.001|TWO_SIDED|90.0|3.69|10.47|||ANOVA|||||10.47|3.69|<0.001
70875606|NCT01025791|141235065|OTHER||1 mg + 0.8 mg vs. placebo|4.39||||0.0211|TWO_SIDED|90.0|0.89|7.09|||ANOVA|||||7.09|0.89|0.0211
70875607|NCT01025791|141235065|OTHER||0.4 mg vs. placebo|0.85||||0.399|TWO_SIDED|90.0|-4.79|6.48|||ANOVA|||||6.48|-4.79|0.399
70875608|NCT01025791|141235065|OTHER||1.2 mg vs. placebo|4.54||||0.1|TWO_SIDED|90.0|-1.94|11.02|||ANOVA|||||11.02|-1.94|0.100
70875609|NCT01025791|141235065|OTHER||1.2 mg + 0.6 mg vs. placebo|3.38||||0.195|TWO_SIDED|90.0|-3.29|10.06|||ANOVA|||||10.06|-3.29|0.195
71148656|NCT03038100|141791418|SUPERIORITY||Odds Ratio (OR)|1.21||||0.3015|TWO_SIDED|95.0|0.84|1.72|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 20 Day 1||1.72|0.84|0.3015
70875610|NCT01025791|141235065|OTHER||1.0 mg + 0.8 mg vs. placebo|9.16||||0.022|TWO_SIDED|90.0|1.74|16.58|||ANOVA|||||16.58|1.74|0.022
70875611|NCT01025791|141235065|OTHER||1.2 mg + 1.0 mg vs. placebo|5.74||||0.098|TWO_SIDED|90.0|-1.68|13.16|||ANOVA|||||13.16|-1.68|0.098
70875612|NCT01025791|141235065|OTHER||1 mg + 0.6 mg + 0.6 mg vs. placebo|3.48||||0.214|TWO_SIDED|90.0|-3.94|10.9|||ANOVA|||||10.90|-3.94|0.214
70875613|NCT01025791|141235065|OTHER||1 mg + 1 mg + 0.6 mg vs. placebo|4.24||||0.163|TWO_SIDED|95.0|-3.03|11.52|||ANOVA|||||11.52|-3.03|0.163
70875614|NCT04649060|141235066|SUPERIORITY||Hazard Ratio (HR)|0.184|||=|0.0032|TWO_SIDED|95.0|0.052|0.65|||Log Rank|||||0.650|0.052|=0.0032
70875615|NCT04649060|141235067|SUPERIORITY|||||||0.03|||||||Cochran-Mantel-Haenszel|||||||0.03
70875616|NCT04649060|141235068|SUPERIORITY||Hazard Ratio (HR)|0.418||||0.525|TWO_SIDED|95.0|0.026|6.693|||Log Rank|||||6.693|0.026|0.525
70875617|NCT04649060|141235070|SUPERIORITY|||||||0.0997|||||||Cochran-Mantel-Haenszel|||||||0.0997
70875618|NCT04649060|141235071|SUPERIORITY||Hazard Ratio (HR)|0.111||||0.016|TWO_SIDED|95.0|0.013|0.96|||Log Rank|||||0.960|0.013|0.016
70875619|NCT04649060|141235073|SUPERIORITY||Hazard Ratio (HR)|0.231||||0.0187|TWO_SIDED|95.0|0.063|0.846|||Log Rank|||||0.846|0.063|0.0187
70875620|NCT04649060|141235074|SUPERIORITY||Hazard Ratio (HR)|0.224||||0.0384|TWO_SIDED|95.0|0.047|1.056|||Log Rank|||||1.056|0.047|0.0384
70875621|NCT04649060|141235075|SUPERIORITY||Hazard Ratio (HR)|0.47||||0.3721|TWO_SIDED|95.0|0.086|2.569|||Log Rank|||||2.569|0.086|0.3721
70875622|NCT02205814|141235095|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Fourhundred evaluable patients were supposed to provide approximately 80% power in rejecting the null hypothesis of equality between any dose of fasitibant and placebo based on previous results and an overall significance level of 5% (two-sided).|mixed linear model for repeated measures|||||||<0.05
70875623|NCT02205814|141235096|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Fourhundred evaluable patients were supposed to provide approximately 80% power in rejecting the null hypothesis of equality between any dose of fasitibant and placebo based on previous results and an overall significance level of 5% (two-sided).|mixed linear model for repeated measures|||All secondary efficacy variables were analysed on the ITT population only. Multiplicity was adjusted using the Hochberg procedure. The continuous secondary efficacy variables were analysed over time and were treated in the same way as the primary efficacy variable with respective output.||||<0.05
70875624|NCT02756689|141235122|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
70875625|NCT02756689|141235123|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||||||0.29
70875626|NCT02756689|141235124|SUPERIORITY||Risk Ratio (RR)|2.1||||0.09|TWO_SIDED|95.0|0.8|5.3|||Chi-squared|||||5.3|0.8|0.09
70875627|NCT02756689|141235125|SUPERIORITY|||||||0.12|||||||Chi-squared|||||||0.12
70875628|NCT02756689|141235126|SUPERIORITY||Risk Ratio (RR)|3.3||||0.06|TWO_SIDED|95.0|0.9|11.4|||Chi-squared|||||11.4|0.9|0.06
70875629|NCT02756689|141235127|SUPERIORITY||Risk Ratio (RR)|0.8||||0.74|TWO_SIDED|95.0|0.2|2.8|||Chi-squared|||||2.8|0.2|0.74
70875630|NCT02756689|141235128|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
70875631|NCT02756689|141235129|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||||||0.82
70875632|NCT02756689|141235130|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
70875633|NCT02756689|141235131|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||||||0.42
70875634|NCT02756689|141235132|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
70875635|NCT02756689|141235133|SUPERIORITY||Risk Ratio (RR)|1.0|||>|0.99|TWO_SIDED|95.0|0.2|4.7|||Chi-squared|||||4.7|0.2|>0.99
70875636|NCT02756689|141235134|SUPERIORITY||Risk Ratio (RR)|0.7||||0.43|TWO_SIDED|95.0|0.3|1.7|||Chi-squared|||||1.7|0.3|0.43
70875637|NCT02756689|141235135|SUPERIORITY||Risk Ratio (RR)|0.3||||0.09|TWO_SIDED|95.0|0.1|1.3|||Chi-squared|||||1.3|0.1|0.09
70875638|NCT02756689|141235136|SUPERIORITY||Risk Ratio (RR)|0.7||||0.68|TWO_SIDED|95.0|0.1|3.8|||Chi-squared|||||3.8|0.1|0.68
71148657|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.98||||0.9059|TWO_SIDED|95.0|0.73|1.32|||Cochran-Mantel-Haenszel|||Social functioning, Completion of Treatment/ Early Termination Visit||1.32|0.73|0.9059
71148658|NCT03038100|141791418|SUPERIORITY||Odds Ratio (OR)|0.93||||0.7125|TWO_SIDED|95.0|0.65|1.35|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 3 Months||1.35|0.65|0.7125
71148659|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.68||||0.0947|TWO_SIDED|95.0|0.43|1.07|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 6 Months||1.07|0.43|0.0947
71148660|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.58||||0.0686|TWO_SIDED|95.0|0.32|1.05|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 9 Months||1.05|0.32|0.0686
71148661|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.39||||0.0175|TWO_SIDED|95.0|0.17|0.86|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 12 Months||0.86|0.17|0.0175
71148662|NCT03038100|141791418|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.46||||0.3376|TWO_SIDED|95.0|0.09|2.3|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 18 Months||2.30|0.09|0.3376
71148663|NCT03038100|141791418|SUPERIORITY||Difference in Proportion of Responders|-50.0||||0.5637|TWO_SIDED|95.0|-100.0|23.34|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 24 Months||23.34|-100.00|0.5637
71148664|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.977|TWO_SIDED|95.0|0.76|1.3|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 3 Day 1||1.30|0.76|0.9770
71148665|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.05||||0.7317|TWO_SIDED|95.0|0.8|1.37|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 5 Day 1||1.37|0.80|0.7317
71148666|NCT03038100|141791419|SUPERIORITY||Odds Ratio (OR)|1.06||||0.6937|TWO_SIDED|95.0|0.8|1.39|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 8 Day 1||1.39|0.80|0.6937
71148667|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.88||||0.3916|TWO_SIDED|95.0|0.66|1.18|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 12 Day 1||1.18|0.66|0.3916
71148668|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.86||||0.3363|TWO_SIDED|95.0|0.63|1.17|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 16 Day 1||1.17|0.63|0.3363
71148669|NCT03038100|141791419|SUPERIORITY||Odds Ratio (OR)|1.08||||0.6761|TWO_SIDED|95.0|0.75|1.55|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 20 Day 1||1.55|0.75|0.6761
71148670|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.6997|TWO_SIDED|95.0|0.71|1.26|||Cochran-Mantel-Haenszel|||Emotional Functioning, Completion of Treatment/ Early Termination Visit||1.26|0.71|0.6997
71148671|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.19||||0.3592|TWO_SIDED|95.0|0.82|1.72|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 3 Months||1.72|0.82|0.3592
71148672|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.97||||0.8798|TWO_SIDED|95.0|0.62|1.51|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 6 Months||1.51|0.62|0.8798
71148673|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.77||||0.3857|TWO_SIDED|95.0|0.43|1.39|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 9 Months||1.39|0.43|0.3857
71148674|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.85||||0.6854|TWO_SIDED|95.0|0.39|1.85|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 12 Months||1.85|0.39|0.6854
71148675|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.54||||0.4533|TWO_SIDED|95.0|0.11|2.7|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 18 Months||2.70|0.11|0.4533
70875639|NCT02756689|141235137|SUPERIORITY||Risk Ratio (RR)|0.8||||0.73|TWO_SIDED|95.0|0.3|2.6|||Chi-squared|||||2.6|0.3|0.73
70875640|NCT02756689|141235138|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.5
70875641|NCT02756689|141235139|SUPERIORITY||Risk Ratio (RR)|1.0|||>|0.99|TWO_SIDED|95.0|0.1|15.4|||Chi-squared|||||15.4|0.1|>0.99
70875642|NCT02756689|141235140|SUPERIORITY||||||>|0.99|||||||Chi-squared|||||||>0.99
70875643|NCT02756689|141235141|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.5
70875644|NCT02756689|141235142|SUPERIORITY||Risk Ratio (RR)|0.3||||0.37|TWO_SIDED|95.0|0.03|2.3|||Chi-squared|||||2.3|0.03|0.37
70875645|NCT02756689|141235143|SUPERIORITY||||||>|0.99|||||||Chi-squared|||||||>0.99
70875646|NCT02756689|141235144|SUPERIORITY||Risk Ratio (RR)|0.5||||0.62|TWO_SIDED|95.0|0.05|5.3|||Chi-squared|||||5.3|0.05|0.62
70875647|NCT02756689|141235145|SUPERIORITY||Risk Ratio (RR)|1.0|||>|0.99|TWO_SIDED|95.0|0.3|3.2|||Chi-squared|||||3.2|0.3|>0.99
70875648|NCT02756689|141235146|SUPERIORITY|||||||0.234|||||||Wilcoxon (Mann-Whitney)|||||||0.234
70875649|NCT02756689|141235147|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
70875650|NCT02756689|141235148|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
70875651|NCT02756689|141235149|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
70875652|NCT02756689|141235150|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.75
70875653|NCT02756689|141235151|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.75
70875654|NCT02756689|141235152|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
71148676|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|-33.33||||0.3173|TWO_SIDED|95.0|-100.0|75.44|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 24 Months||75.44|-100.00|0.3173
71148677|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.13||||0.3658|TWO_SIDED|95.0|0.87|1.47|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 3 Day 1||1.47|0.87|0.3658
71148678|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.04||||0.7619|TWO_SIDED|95.0|0.8|1.36|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 5 Day 1||1.36|0.80|0.7619
71148679|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.06||||0.658|TWO_SIDED|95.0|0.81|1.4|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 8 Day 1||1.40|0.81|0.6580
71148680|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.18||||0.2726|TWO_SIDED|95.0|0.88|1.57|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 12 Day 1||1.57|0.88|0.2726
71148681|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.6973|TWO_SIDED|95.0|0.69|1.29|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 16 Day 1||1.29|0.69|0.6973
71148682|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.15||||0.447|TWO_SIDED|95.0|0.8|1.64|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 20 Day 1||1.64|0.80|0.4470
71148683|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.91||||0.515|TWO_SIDED|95.0|0.68|1.21|||Cochran-Mantel-Haenszel|||Physical functioning, Completion of Treatment/ Early Termination Visit||1.21|0.68|0.5150
71148684|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.26||||0.2103|TWO_SIDED|95.0|0.88|1.82|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 3 Months||1.82|0.88|0.2103
71148685|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.06||||0.7969|TWO_SIDED|95.0|0.68|1.66|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 6 Months||1.66|0.68|0.7969
71148686|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.07||||0.83|TWO_SIDED|95.0|0.6|1.91|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 9 Months||1.91|0.60|0.8300
71148687|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.17||||0.6987|TWO_SIDED|95.0|0.53|2.55|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 12 Months||2.55|0.53|0.6987
71148688|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|3.32||||0.1441|TWO_SIDED|95.0|0.62|17.77|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 18 Months||17.77|0.62|0.1441
71148689|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Difference in proportion of Responders|-66.67||||0.3173|TWO_SIDED|95.0|-100.0|4.39|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 24 Months||4.39|-100.00|0.3173
71148690|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.96||||0.7591|TWO_SIDED|95.0|0.74|1.25|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Cycle 3 Day 1||1.25|0.74|0.7591
71148691|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.09||||0.5403|TWO_SIDED|95.0|0.83|1.42|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Cycle 5 Day 1||1.42|0.83|0.5403
71148692|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.17||||0.2654|TWO_SIDED|95.0|0.89|1.55|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Cycle 8 Day 1||1.55|0.89|0.2654
71148693|NCT03038100|141791419|SUPERIORITY||Odds Ratio (OR)|1.1||||0.5138|TWO_SIDED|95.0|0.82|1.48|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Cycle 12 Day 1||1.48|0.82|0.5138
71148694|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.22||||0.2138|TWO_SIDED|95.0|0.89|1.67|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Cycle 16 Day 1||1.67|0.89|0.2138
71148695|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.26||||0.2114|TWO_SIDED|95.0|0.88|1.82|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Cycle 20 Day 1||1.82|0.88|0.2114
71148696|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.14||||0.3938|TWO_SIDED|95.0|0.85|1.53|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Completion of Treatment/ Early Termination Visit||1.53|0.85|0.3938
71148697|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.95||||0.7793|TWO_SIDED|95.0|0.65|1.38|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Post-Treatment Follow Up 3 Months||1.38|0.65|0.7793
71148698|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.08||||0.737|TWO_SIDED|95.0|0.69|1.39|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Post-Treatment Follow Up 6 Months||1.39|0.69|0.7370
71148699|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.99||||0.9658|TWO_SIDED|95.0|0.55|1.79|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Post-Treatment Follow Up 9 Months||1.79|0.55|0.9658
71148700|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.66||||0.3015|TWO_SIDED|95.0|0.29|1.46|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Post-Treatment Follow Up 12 Months||1.46|0.29|0.3015
71148701|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.77||||0.7534|TWO_SIDED|95.0|0.15|3.94|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Post-Treatment Follow Up 18 Months||3.94|0.15|0.7534
71148702|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|16.67||||0.5637|TWO_SIDED|95.0|-46.49|79.82|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Post-Treatment Follow Up 24 Months||79.82|-46.49|0.5637
71148703|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.8||||0.1177|TWO_SIDED|95.0|0.61|1.06|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 3 Day 1||1.06|0.61|0.1177
71148704|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.17||||0.273|TWO_SIDED|95.0|0.88|1.56|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 5 Day 1||1.56|0.88|0.2730
71148705|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.99||||0.9306|TWO_SIDED|95.0|0.73|1.33|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 8 Day 1||1.33|0.73|0.9306
71148706|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.97||||0.8631|TWO_SIDED|95.0|0.72|1.32|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 12 Day 1||1.32|0.72|0.8631
71148707|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.33||||0.0977|TWO_SIDED|95.0|0.95|1.86|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 16 Day 1||1.86|0.95|0.0977
71148708|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.43||||0.0726|TWO_SIDED|95.0|0.97|2.1|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 20 Day 1||2.10|0.97|0.0726
71148709|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.9974|TWO_SIDED|95.0|0.73|1.38|||Cochran-Mantel-Haenszel|||Role functioning, Completion of Treatment/ Early Termination Visit||1.38|0.73|0.9974
71148710|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.08||||0.7069|TWO_SIDED|95.0|0.72|1.63|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 3 Months||1.63|0.72|0.7069
71148711|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.3||||0.3068|TWO_SIDED|95.0|0.78|2.16|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 6 Months||2.16|0.78|0.3068
71148712|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.64||||0.1375|TWO_SIDED|95.0|0.85|3.16|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 9 Months||3.16|0.85|0.1375
71148713|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.02||||0.954|TWO_SIDED|95.0|0.46|2.29|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 12 Months||2.29|0.46|0.9540
71148714|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.53||||0.4283|TWO_SIDED|95.0|0.1|2.64|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 18 Months||2.64|0.10|0.4283
71148715|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|16.67|||||TWO_SIDED|95.0|-95.56|100.0||||||Role functioning, Post-Treatment Follow Up 24 Months||100.00|-95.56|
71148716|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.84||||0.2153|TWO_SIDED|95.0|0.64|1.1|||Cochran-Mantel-Haenszel|||Social Functioning, Cycle 3 Day 1||1.10|0.64|0.2153
71148717|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.96||||0.7878|TWO_SIDED|95.0|0.73|1.27|||Cochran-Mantel-Haenszel|||Social Functioning, Cycle 5 Day 1||1.27|0.73|0.7878
71148718|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.81||||0.1544|TWO_SIDED|95.0|0.61|1.08|||Cochran-Mantel-Haenszel|||Social Functioning, Cycle 8 Day 1||1.08|0.61|0.1544
71148719|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.04||||0.8017|TWO_SIDED|95.0|0.77|1.4|||Cochran-Mantel-Haenszel|||Social Functioning, Cycle 12 Day 1||1.40|0.77|0.8017
71148720|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.88||||0.4295|TWO_SIDED|95.0|0.63|1.21|||Cochran-Mantel-Haenszel|||Social Functioning, Cycle 16 Day 1||1.21|0.63|0.4295
70875655|NCT02756689|141235153|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
71148721|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio, log|0.99||||0.954|TWO_SIDED|95.0|0.68|1.44|||Cochran-Mantel-Haenszel|||Social Functioning, Cycle 20 Day 1||1.44|0.68|0.9540
71148722|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.95||||0.7494|TWO_SIDED|95.0|0.69|1.3|||Cochran-Mantel-Haenszel|||Social Functioning, Completion of Treatment/ Early Termination Visit||1.30|0.69|0.7494
71148723|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.1||||0.6412|TWO_SIDED|95.0|0.74|1.62|||Cochran-Mantel-Haenszel|||Social Functioning, Post-Treatment Follow Up 3 Months||1.62|0.74|0.6412
71148724|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.04||||0.8652|TWO_SIDED|95.0|0.65|1.67|||Cochran-Mantel-Haenszel|||Social Functioning, Post-Treatment Follow Up 6 Months||1.67|0.65|0.8652
71148725|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.14||||0.6912|TWO_SIDED|95.0|0.6|2.18|||Cochran-Mantel-Haenszel|||Social Functioning, Post-Treatment Follow Up 9 Months||2.18|0.60|0.6912
71148726|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.79||||0.5834|TWO_SIDED|95.0|0.33|1.86|||Cochran-Mantel-Haenszel|||Social Functioning, Post-Treatment Follow Up 12 Months||1.86|0.33|0.5834
71148727|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.93||||0.9578|TWO_SIDED|95.0|0.05|16.05|||Cochran-Mantel-Haenszel|||Social Functioning, Post-Treatment Follow Up 18 Months||16.05|0.05|0.9578
71148728|NCT03038100|141791419|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|16.67||||0.5637|TWO_SIDED|95.0|-46.49|79.82|||Cochran-Mantel-Haenszel|||Social Functioning, Post-Treatment Follow Up 24 Months||79.82|-46.49|0.5637
71148729|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.11||||0.6063|TWO_SIDED|95.0|0.75|1.63|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 3 Day 1||1.63|0.75|0.6063
71148730|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.9||||0.5739|TWO_SIDED|95.0|0.63|1.29|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 5 Day 1||1.29|0.63|0.5739
71148731|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.84||||0.3792|TWO_SIDED|95.0|0.56|1.25|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 8 Day 1||1.25|0.56|0.3792
71148732|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.12||||0.6022|TWO_SIDED|95.0|0.73|1.73|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 12 Day 1||1.73|0.73|0.6022
71148733|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.7893|TWO_SIDED|95.0|0.59|1.49|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 16 Day 1||1.49|0.59|0.7893
71148734|NCT03038100|141791420|SUPERIORITY||Odds Ratio (OR)|0.71||||0.2125|TWO_SIDED|95.0|0.42|1.22|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 20 Day 1||1.22|0.42|0.2125
71148735|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.01||||0.9661|TWO_SIDED|95.0|0.7|1.46|||Cochran-Mantel-Haenszel|||Emotional functioning, Completion of Treatment/ Early Termination Visit||1.46|0.70|0.9661
71148736|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.83||||0.4299|TWO_SIDED|95.0|0.52|1.32|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 3 Months||1.32|0.52|0.4299
71148737|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.65||||0.1542|TWO_SIDED|95.0|0.36|1.18|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 6 Months||1.18|0.36|0.1542
71148738|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.65||||0.0363|TWO_SIDED|95.0|1.04|6.76|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 9 Months||6.76|1.04|0.0363
71148739|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.75||||0.0814|TWO_SIDED|95.0|0.85|8.93|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 12 Months||8.93|0.85|0.0814
71148740|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|4.03||||0.1915|TWO_SIDED|95.0|0.43|38.0|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 18 Months||38.00|0.43|0.1915
71148741|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|66.67||||0.3173|TWO_SIDED|95.0|-4.39|100.0|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 24 Months||100.00|-4.39|0.3173
71148742|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.9818|TWO_SIDED|95.0|0.73|1.35|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 3 Day 1||1.35|0.73|0.9818
70875656|NCT02756689|141235154|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
71148743|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.08||||0.6263|TWO_SIDED|95.0|0.8|1.45|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 5 Day 1||1.45|0.80|0.6263
71148744|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.01||||0.9407|TWO_SIDED|95.0|0.73|1.4|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 8 Day 1||1.40|0.73|0.9407
71148745|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.77|TWO_SIDED|95.0|0.64|1.39|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 12 Day 1||1.39|0.64|0.7700
71148746|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.96||||0.8458|TWO_SIDED|95.0|0.63|1.45|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 16 Day 1||1.45|0.63|0.8458
70875657|NCT02756689|141235155|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.75
70875658|NCT02756689|141235156|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
70875659|NCT02756689|141235157|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
70875660|NCT02756689|141235158|SUPERIORITY|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
70875661|NCT02756689|141235159|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
70875662|NCT02756689|141235160|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
70875663|NCT02756689|141235161|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||||||0.83
71148747|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.91||||0.7028|TWO_SIDED|95.0|0.57|1.46|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 20 Day 1||1.46|0.57|0.7028
71148748|NCT03038100|141791420|SUPERIORITY||Odds Ratio (OR)|1.3||||0.1391|TWO_SIDED|95.0|0.92|1.83|||Cochran-Mantel-Haenszel|||Physical functioning, Completion of Treatment/ Early Termination Visit||1.83|0.92|0.1391
71148749|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.06||||0.8002|TWO_SIDED|95.0|0.69|1.62|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 3 Months||1.62|0.69|0.8002
71148750|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.01||||0.9751|TWO_SIDED|95.0|0.6|1.68|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 6 Months||1.68|0.60|0.9751
71148751|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.37||||0.3811|TWO_SIDED|95.0|0.68|2.78|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 9 Months||2.78|0.68|0.3811
71148752|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.51||||0.395|TWO_SIDED|95.0|0.58|3.9|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 12 Months||3.90|0.58|0.3950
71148753|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.89||||0.8993|TWO_SIDED|95.0|0.16|5.12|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 18 Months||5.12|0.16|0.8993
70875664|NCT02756689|141235162|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.60
70875665|NCT01018186|141235175|SUPERIORITY_OR_OTHER||Ratio|1.67|||||TWO_SIDED|95.0|1.34|2.08|||||Ratio of FF/VI 100/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 12|||2.08|1.34|
71148754|NCT03038100|141791420|SUPERIORITY|Stratified|Difference in Proportion of Responders|50.0||||0.3173|TWO_SIDED|95.0|-23.34|100.0|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 24 Months||100.00|-23.34|0.3173
71148755|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.92||||0.5988|TWO_SIDED|95.0|0.68|1.25|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 3 Day 1||1.25|0.68|0.5988
71148756|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.98||||0.8859|TWO_SIDED|95.0|0.72|1.34|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 5 Day 1||1.34|0.72|0.8859
71148757|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.82||||0.2531|TWO_SIDED|95.0|0.58|1.16|||Cochran-Mantel-Haenszel|Stratified Analysis||Global health status/QoL, Cycle 8 Day 1||1.16|0.58|0.2531
70875666|NCT01018186|141235175|SUPERIORITY_OR_OTHER||Ratio|1.65|||||TWO_SIDED|95.0|1.29|2.13|||||Ratio of FF/VI 100/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 28|||2.13|1.29|
71148758|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.69||||0.0785|TWO_SIDED|95.0|0.46|1.04|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 12 Day 1||1.04|0.46|0.0785
71148759|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.67||||0.0641|TWO_SIDED|95.0|0.43|1.03|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 16 Day 1||1.03|0.43|0.0641
71148760|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.48||||0.0046|TWO_SIDED|95.0|0.29|0.8|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 20 Day 1||0.80|0.29|0.0046
71148761|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.98||||0.8928|TWO_SIDED|95.0|0.7|1.37|||Cochran-Mantel-Haenszel|||Global health status/QoL, Completion of Treatment/ Early Termination Visit||1.37|0.70|0.8928
71148762|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.12||||0.6106|TWO_SIDED|95.0|0.72|1.74|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 3 Months||1.74|0.72|0.6106
70875667|NCT01018186|141235175|SUPERIORITY_OR_OTHER||Ratio|1.05|||||TWO_SIDED|95.0|0.83|1.33|||||Ratio of FF/VI 100/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 52|||1.33|0.83|
71148763|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.15||||0.6159|TWO_SIDED|95.0|0.67|1.95|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 6 Months||1.95|0.67|0.6159
71148764|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.24||||0.5372|TWO_SIDED|95.0|0.62|2.49|||Cochran-Mantel-Haenszel|Stratified Analysis||Global health status/QoL, Post-Treatment Follow Up 9 Months||2.49|0.62|0.5372
71148765|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.22||||0.0845|TWO_SIDED|95.0|0.89|5.58|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 12 Months||5.58|0.89|0.0845
71148766|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|3.67||||0.1344|TWO_SIDED|95.0|0.62|21.56|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 18 Months||21.56|0.62|0.1344
70875668|NCT01018186|141235175|SUPERIORITY_OR_OTHER||Ratio|1.52|||||TWO_SIDED|95.0|1.22|1.89|||||Ratio of FF/VI 200/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 12|||1.89|1.22|
70875669|NCT01018186|141235175|SUPERIORITY_OR_OTHER||Ratio|1.43|||||TWO_SIDED|95.0|1.11|1.84|||||Ratio of FF/VI 200/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 28|||1.84|1.11|
71148767|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|50.0||||0.3173|TWO_SIDED|95.0|-23.34|100.0|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 24 Months||100.00|-23.34|0.3173
71148768|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.41||||0.026|TWO_SIDED|95.0|1.04|1.92|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 3 Day 1||1.92|1.04|0.0260
71148769|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.02||||0.9179|TWO_SIDED|95.0|0.75|1.37|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 5 Day 1||1.37|0.75|0.9179
71148770|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.1||||0.582|TWO_SIDED|95.0|0.79|1.53|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 8 Day 1||1.53|0.79|0.5820
71148771|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.99||||0.9772|TWO_SIDED|95.0|0.67|1.47|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 12 Day 1||1.47|0.67|0.9772
71148772|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.73||||0.13|TWO_SIDED|95.0|0.49|1.1|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 16 Day 1||1.10|0.49|0.1300
71148773|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.66||||0.099|TWO_SIDED|95.0|0.4|1.08|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 20 Day 1||1.08|0.40|0.0990
71148774|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.07||||0.7133|TWO_SIDED|95.0|0.76|1.5|||Cochran-Mantel-Haenszel|||Role functioning, Completion of Treatment/ Early Termination Visit||1.50|0.76|0.7133
71148775|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.38||||0.1384|TWO_SIDED|95.0|0.9|2.11|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 3 Months||2.11|0.90|0.1384
71148776|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.33||||0.2895|TWO_SIDED|95.0|0.78|2.26|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 6 Months||2.26|0.78|0.2895
71148777|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.55||||0.2221|TWO_SIDED|95.0|0.77|3.14|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 9 Months||3.14|0.77|0.2221
71148778|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|7.37||||0.0005|TWO_SIDED|95.0|2.08|26.1|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 12 Months||26.10|2.08|0.0005
71148779|NCT03038100|141791420|SUPERIORITY||Odds Ratio (OR)|3.72||||0.2171|TWO_SIDED|95.0|0.4|34.56|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 18 Months||34.56|0.40|0.2171
71148780|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|16.67|||||TWO_SIDED|95.0|-46.49|79.82||||||Role functioning, Post-Treatment Follow Up 24 Months||79.82|-46.49|
71148781|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.11||||0.4647|TWO_SIDED|95.0|0.84|1.48|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 3 Day 1||1.48|0.84|0.4647
71148782|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.04||||0.7676|TWO_SIDED|95.0|0.78|1.4|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 5 Day 1||1.40|0.78|0.7676
71148783|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.24||||0.1983|TWO_SIDED|95.0|0.89|1.71|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 8 Day 1||1.71|0.89|0.1983
71148784|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.9874|TWO_SIDED|95.0|0.69|1.44|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 12 Day 1||1.44|0.69|0.9874
71148785|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.86||||0.4716|TWO_SIDED|95.0|0.58|1.29|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 16 Day 1||1.29|0.58|0.4716
71148786|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.74||||0.2041|TWO_SIDED|95.0|0.46|1.18|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 20 Day 1||1.18|0.46|0.2041
71148787|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.05||||0.7771|TWO_SIDED|95.0|0.76|1.45|||Cochran-Mantel-Haenszel|||Social functioning, Completion of Treatment/ Early Termination Visit||1.45|0.76|0.7771
71148788|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.96||||0.8542|TWO_SIDED|95.0|0.64|1.45|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 3 Months||1.45|0.64|0.8542
71148789|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.5||||0.123|TWO_SIDED|95.0|0.9|2.5|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 6 Months||2.50|0.90|0.1230
71148790|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.72||||0.1089|TWO_SIDED|95.0|0.88|3.34|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 9 Months||3.34|0.88|0.1089
70875670|NCT01018186|141235175|SUPERIORITY_OR_OTHER||Ratio|1.09|||||TWO_SIDED|95.0|0.87|1.38|||||Ratio of FF/VI 200/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 52|||1.38|0.87|
70875671|NCT01018186|141235176|SUPERIORITY_OR_OTHER||Ratio of LSGM to Baseline|1.67|||<|0.001|TWO_SIDED|95.0|1.34|2.08|||ANCOVA|||||2.08|1.34|<0.001
70875672|NCT01018186|141235176|SUPERIORITY_OR_OTHER||Ratio of LSGM to Baseline|1.52|||<|0.001|TWO_SIDED|95.0|1.22|1.89|||ANCOVA|||||1.89|1.22|<0.001
70875673|NCT01018186|141235177|SUPERIORITY_OR_OTHER||Ratio of LSGM to Baseline|1.65|||<|0.001|TWO_SIDED|95.0|1.29|2.13|||ANCOVA|||||2.13|1.29|<0.001
70875674|NCT01018186|141235177|SUPERIORITY_OR_OTHER||Ratio of LSGM to Baseline|1.43||||0.006|TWO_SIDED|95.0|1.11|1.84|||ANCOVA|||||1.84|1.11|0.006
71148791|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|5.82||||0.0011|TWO_SIDED|95.0|1.85|18.3|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 12 Months||18.30|1.85|0.0011
71148792|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.51||||0.295|TWO_SIDED|95.0|0.43|14.74|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 18 Months||14.74|0.43|0.2950
71148793|NCT03038100|141791420|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|33.33|||||TWO_SIDED|95.0|-37.72|100.0||||||Social functioning, Post-Treatment Follow Up 24 Months||100.00|-37.72|
71148794|NCT00918255|141791425|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Cochran-Mantel-Haenszel|||||||0.022
71148795|NCT00918255|141791425|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.025
71148796|NCT00918255|141791425|SUPERIORITY_OR_OTHER|||||||0.252||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.252
71148797|NCT00918255|141791426|SUPERIORITY_OR_OTHER|||||||0.062||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|ANCOVA|||||||0.062
71148798|NCT00918255|141791426|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||ANCOVA|Analyzed using ANCOVA adjusting for Baseline Hurley Stage (I/II vs III).||||||0.019
71148799|NCT00918255|141791426|SUPERIORITY_OR_OTHER|||||||0.286||95.0|||||ANCOVA|Analyzed using ANCOVA adjusting for Baseline Hurley Stage (I/II vs III).||||||0.286
71148800|NCT00918255|141791427|SUPERIORITY_OR_OTHER|||||||1||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Cochran-Mantel-Haenszel|||||||1.000
71148801|NCT00918255|141791427|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||1.000
71148802|NCT00918255|141791427|SUPERIORITY_OR_OTHER|||||||0.097||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.097
71148803|NCT00918255|141791428|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Cochran-Mantel-Haenszel|||||||0.044
71148804|NCT00918255|141791428|SUPERIORITY_OR_OTHER|||||||0.051||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.051
71148805|NCT00918255|141791428|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.320
71148806|NCT00918255|141791429|SUPERIORITY_OR_OTHER|||||||1||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Cochran-Mantel-Haenszel|||||||1.000
71148807|NCT00918255|141791429|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||1.000
70875675|NCT01018186|141235178|SUPERIORITY_OR_OTHER||Ratio of LSGM to Baseline|1.05||||0.674|TWO_SIDED|95.0|0.83|1.33|||ANCOVA|||||1.33|0.83|0.674
70875676|NCT01018186|141235178|SUPERIORITY_OR_OTHER||Ratio of LSGM to Baseline|1.09||||0.444|TWO_SIDED|95.0|0.87|1.38|||ANCOVA|||||1.38|0.87|0.444
71148808|NCT00918255|141791429|SUPERIORITY_OR_OTHER|||||||0.673||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.673
71148809|NCT00918255|141791430|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Cochran-Mantel-Haenszel|||||||0.012
71148810|NCT00918255|141791430|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.020
71148811|NCT00918255|141791430|SUPERIORITY_OR_OTHER|||||||0.721||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.721
71148812|NCT00918255|141791431|SUPERIORITY_OR_OTHER|||||||0.045||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Van Elteren test|||||||0.045
71148813|NCT00918255|141791431|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Van Elteren test|Analyzed using Van Elteren test stratified by Hurley Stage.||||||0.014
71148814|NCT00918255|141791431|SUPERIORITY_OR_OTHER|||||||0.169||95.0|||||Van Elteren test|Analyzed using Van Elteren test stratified by Hurley Stage.||||||0.169
70875677|NCT03552198|141235195|OTHER|||||||0.964|||||||ANCOVA|ANCOVA, adjusted for baseline measures, tested for differences between intervention and control groups in preventative behaviours at 4 weeks||We predicted that the groups receiving the alternative format of air quality notifications would report greater frequency of behaviour change at 4 weeks compared to the groups receiving the usual format.||||.964
71148815|NCT02392624|141791434|SUPERIORITY||Clinical Worsening Rate Difference|-39.4|||<|0.0001|TWO_SIDED|95.0|-54.5|-22.5|||Chi-squared|||For participants who transitioned to open-label omalizumab, data prior to the date of transitioning was used for analysis.||-22.5|-54.5|<0.0001
70875678|NCT03552198|141235196|OTHER|||||||0.043|||||||Chi-squared|χ2(1)=4.11, V=0.229||We predicted that more respondents in the intervention groups (i.e. receiving alternative health advice) would consider making permanent changes to their daily travel route, exercise location or exercise time compared to the control groups||||0.043
70875679|NCT03552198|141235197|OTHER||||||>|0.05|||||||Fisher Exact|||We predicted that the alternative health advice would lead to greater actual behaviour change compared to the usual format||||>0.05
71148816|NCT02392624|141791435|SUPERIORITY||||||<|0.0001|||||||Log Rank|||For participants who transitioned to open-label omalizumab, data prior to the date of transitioning was used for analysis.||||<0.0001
71148817|NCT02392624|141791436|SUPERIORITY||Clinical Worsening Rate Difference|-32.1||||0.0004|TWO_SIDED|95.0|-47.9|-14.9|||Chi-squared|||For participants who transitioned to open-label omalizumab, data prior to the date of transitioning was used for analysis.||-14.9|-47.9|0.0004
71148818|NCT02392624|141791437|OTHER||||||<|0.0001|||||||One-sample t-test, 1 sided|The p-value from this test was used to determine the importance of continued treatment in this study. P-value is one-sided with alpha = 0.05.||The null hypothesis for this test was that the mean change from Week 24 to Week 48 in UAS7 score was \>/=5 and the alternative hypothesis was that the mean change from Week 24 to Week 48 in UAS7 score was \<5.||||<0.0001
71148819|NCT02392624|141791438|OTHER||||||<|0.0001|||||||One-sample t-test, 2 sided|The p-value from this test was used to evaluate the importance of retreatment after experiencing clinical worsening.||The null hypothesis for this test was that the mean change from the time of retreatment to 12 weeks after retreatment in UAS7 was zero and the alternative hypothesis was that this change was non-zero.||||<0.0001
71148820|NCT01193244|141791454|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.707|||<|1e-05||95.0|0.626|0.799|||Log Rank|||Hazard ratio is based on a stratified Cox's proportional hazard regression model with stratification factors of region and radiographic disease progression at baseline with treatment as a factor in the model. A hazard ratio less than (\<) 1 indicated better prevention of death in the orteronel group compared to the placebo group. From log-rank test stratified by region and radiographic disease progression at Baseline.||0.799|0.626|<0.00001
71148821|NCT01193244|141791455|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.963||||0.59755||95.0|0.838|1.107|||Log Rank|||Hazard ratio is based on a stratified Cox's proportional hazard regression model with stratification factors of region and radiographic disease progression at baseline with treatment as a factor in the model. A hazard ratio \<1 indicated better prevention of death in the orteronel group compared to the placebo group. From log-rank test stratified by region and radiographic disease progression at baseline.||1.107|0.838|0.59755
71148822|NCT01193244|141791456|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.166|||<|0.001||95.0|1.724|2.721|||Regression, Logistic|||Logistic regression model with prognostic factors: region; radiographic disease progression at baseline; age; race; baseline Eastern Cooperative Oncology Group (ECOG) score; Gleason score at initial diagnosis; baseline PSA, natural log scale; presence of visceral disease; alkaline phosphatase; lactate dehydrogenase; and hemoglobin. Odds ratio greater than (\>)1 favored orteronel. P-values tested for odds ratio equal to 1.||2.721|1.724|<0.001
71148823|NCT01193244|141791457|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.712||||0.001||95.0|1.235|2.373|||Regression, Logistic|||Logistic regression model with prognostic factors: region; radiographic disease progression at baseline; age; race; baseline ECOG score; Gleason score at initial diagnosis; baseline PSA, natural log scale; presence of visceral disease; alkaline phosphatase; lactate dehydrogenase; and hemoglobin. Odds ratio \> 1 favored orteronel. P-values tested for odds ratio equal to 1.||2.373|1.235|0.001
71148824|NCT01193244|141791458|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.885||||0.33906||95.0|0.688|1.138|||Log Rank|||Hazard ratio is based on a stratified Cox's proportional hazard regression model with stratification factors of region and radiographic disease progression at baseline with treatment as a factor in the model. A hazard ratio less than (\<) 1 indicated better prevention of death in the orteronel group compared to the placebo group. From log-rank test stratified by region and radiographic disease progression at baseline.||1.138|0.688|0.33906
71148825|NCT03763877|141791484|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|7.926||0.9883|TWO_SIDED|95.0|-15.42|15.66|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||15.66|-15.42|0.9883
70875680|NCT03552198|141235198|OTHER||||||>|0.05|||||||ANCOVA|ANCOVA, adjusted for baseline intentions, tested for differences between groups in intentions in relation to an high-air-pollution scenario at 4 weeks||We predicted that the alternative format would lead to stronger intentions to adhere to recommendations associated with an hypothetical high air pollution episode compared to the usual format.||||>0.05
70875681|NCT02326025|141235204|SUPERIORITY||Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|0.964|1.13|||||Log(PK) is participant and treatment and random error, where participant is fitted as a random effect.|||1.13|0.964|
70875682|NCT02326025|141235204|SUPERIORITY||Ratio of LS Means|1.03|||||TWO_SIDED|90.0|0.957|1.11||||||||1.11|0.957|
70875683|NCT02326025|141235205|SUPERIORITY||Ratio of LS Means|0.944|||||TWO_SIDED|90.0|0.77|1.16||||||||1.16|0.770|
71148826|NCT03763877|141791484|SUPERIORITY||Mean Difference (Final Values)|-13.14|STANDARD_ERROR_OF_MEAN|7.609||0.0842|TWO_SIDED|95.0|-28.06|1.78|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||1.78|-28.06|0.0842
71148827|NCT03763877|141791484|SUPERIORITY||Mean Difference (Final Values)|-13.54|STANDARD_ERROR_OF_MEAN|7.636||0.0763|TWO_SIDED|95.0|-28.51|1.43|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||1.43|-28.51|0.0763
71148828|NCT03763877|141791485|SUPERIORITY||Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|7.265||0.8283|TWO_SIDED|95.0|-16.01|12.85|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||12.85|-16.01|0.8283
71148829|NCT03763877|141791485|SUPERIORITY||Mean Difference (Final Values)|-13.25|STANDARD_ERROR_OF_MEAN|7.221||0.0698|TWO_SIDED|95.0|-27.6|1.1|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||1.10|-27.60|0.0698
71148830|NCT03763877|141791485|SUPERIORITY||Mean Difference (Final Values)|-17.31|STANDARD_ERROR_OF_MEAN|7.207||0.0184|TWO_SIDED|95.0|-31.63|-2.99|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||-2.99|-31.63|0.0184
71148831|NCT03763877|141791486|SUPERIORITY||Location Shift|-4.22||||0.5537|TWO_SIDED|95.0|-15.64|8.65|||Wilcoxon (Mann-Whitney)|||||8.65|-15.64|0.5537
71148832|NCT03763877|141791486|SUPERIORITY||Location Shift|-13.64||||0.1005|TWO_SIDED|95.0|-26.19|1.88|||Wilcoxon (Mann-Whitney)|||||1.88|-26.19|0.1005
71148833|NCT03763877|141791486|SUPERIORITY||Location Shift|-18.72||||0.0387|TWO_SIDED|95.0|-31.95|-1.58|||Wilcoxon (Mann-Whitney)|||||-1.58|-31.95|0.0387
71148834|NCT03763877|141791487|SUPERIORITY||Mean Difference (Final Values)|7.25|STANDARD_ERROR_OF_MEAN|0.5733||0.5733|TWO_SIDED|95.0|-18.0|32.51|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||32.51|-18.00|0.5733
71148835|NCT03763877|141791487|SUPERIORITY||Mean Difference (Final Values)|-10.61|STANDARD_ERROR_OF_MEAN|12.236||0.3861|TWO_SIDED|95.0|-34.6|13.38|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||13.38|-34.60|0.3861
71148836|NCT03763877|141791487|SUPERIORITY||Mean Difference (Final Values)|-21.13|STANDARD_ERROR_OF_MEAN|12.916||0.1019|TWO_SIDED|95.0|-46.46|4.19|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||4.19|-46.46|0.1019
71148837|NCT03763877|141791488|SUPERIORITY||Mean Difference (Final Values)|-0.242|STANDARD_ERROR_OF_MEAN|1.3873||0.8617|TWO_SIDED|95.0|-2.961|2.478|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||2.478|-2.961|0.8617
71148838|NCT03763877|141791488|SUPERIORITY||Mean Difference (Final Values)|-2.571|STANDARD_ERROR_OF_MEAN|1.3712||0.0609|TWO_SIDED|95.0|-5.26|0.117|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method|||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|0.117|-5.260|0.0609
71148839|NCT03763877|141791488|SUPERIORITY||Mean Difference (Final Values)|-2.414|STANDARD_ERROR_OF_MEAN|1.3633||0.0766|TWO_SIDED|95.0|-5.087|0.258|||ANCOVA|ANCOVA using a multiple imputation procedure based on the fully conditional specification method|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||0.258|-5.087|0.0766
71148840|NCT03763877|141791489|SUPERIORITY||Odds Ratio (OR)|1.744||||0.5592|TWO_SIDED|95.0|0.27|11.267|||Regression, Logistic|Logistic regression with multiple imputation||||11.267|0.270|0.5592
71148841|NCT03763877|141791489|SUPERIORITY||Odds Ratio (OR)|2.287||||0.3747|TWO_SIDED|95.0|0.368|14.208|||Regression, Logistic|Logistic regression with multiple imputation||||14.208|0.368|0.3747
71148842|NCT03763877|141791489|SUPERIORITY||Odds Ratio (OR)|5.669||||0.0501|TWO_SIDED|95.0|1.0|32.149|||Regression, Logistic|Logistic regression with multiple imputation||||32.149|1.000|0.0501
71148843|NCT03763877|141791490|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|3.71||0.8013|TWO_SIDED|95.0|-8.3|6.4|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||6.4|-8.3|0.8013
71148844|NCT03763877|141791490|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|3.81||0.8694|TWO_SIDED|95.0|-8.2|7.0|||Mixed Models Analysis|Mixed Model Repeated Measures|||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|7.0|-8.2|0.8694
71148845|NCT03763877|141791490|SUPERIORITY||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|3.8||0.0581|TWO_SIDED|95.0|-14.9|0.3|||Mixed Models Analysis|Mixed Model Repeated Measures|||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|0.3|-14.9|0.0581
70875684|NCT02326025|141235205|SUPERIORITY||Ratio of LS Means|1.03|||||TWO_SIDED|90.0|0.801|1.33||||||||1.33|0.801|
70875685|NCT00001723|141235212|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||ANCOVA|||||||0.007
70875686|NCT02643082|141235217|SUPERIORITY||LS Mean ratio between treatments|1.75|||<|0.0001|TWO_SIDED|95.0|1.65|1.86|||Mixed Models Analysis|||||1.86|1.65|<0.0001
70875687|NCT02643082|141235218|SUPERIORITY||LS Mean ratio between treatments|0.29|||<|0.0001|TWO_SIDED|95.0|0.26|0.33|||Mixed Models Analysis|||||0.33|0.26|<0.0001
71148846|NCT03763877|141791491|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|2.44||0.6681|TWO_SIDED|95.0|-3.8|5.9|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||5.9|-3.8|0.6681
71148847|NCT03763877|141791491|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|2.51||0.8224|TWO_SIDED|95.0|-4.4|5.5|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||5.5|-4.4|0.8224
71148848|NCT03763877|141791491|SUPERIORITY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|2.5||0.0924|TWO_SIDED|95.0|-9.2|0.7|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.7|-9.2|0.0924
71148849|NCT03763877|141791492|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.256||0.5148|TWO_SIDED|95.0|-0.68|0.34|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.34|-0.68|0.5148
71148850|NCT03763877|141791492|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.261||0.0434|TWO_SIDED|95.0|-1.05|-0.02|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-0.02|-1.05|0.0434
71148851|NCT03763877|141791492|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.261||0.0494|TWO_SIDED|95.0|-1.04|0.0|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.00|-1.04|0.0494
71148852|NCT03763877|141791493|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.111||0.2449|TWO_SIDED|95.0|-0.35|0.09|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.|||0.09|-0.35|0.2449
71148853|NCT03763877|141791493|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.115||0.0502|TWO_SIDED|95.0|-0.46|0.0|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.|||0.00|-0.46|0.0502
71148854|NCT03763877|141791493|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.113||0.0123|TWO_SIDED|95.0|-0.51|-0.06|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.|||-0.06|-0.51|0.0123
71148855|NCT03763877|141791494|SUPERIORITY||Mean Difference (Final Values)|-0.251|STANDARD_ERROR_OF_MEAN|0.2172||0.251|TWO_SIDED|95.0|-0.682|0.18|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.180|-0.682|0.2510
71148856|NCT03763877|141791494|SUPERIORITY||Mean Difference (Final Values)|-0.049|STANDARD_ERROR_OF_MEAN|0.2202||0.8246|TWO_SIDED|95.0|-0.486|0.388|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.388|-0.486|0.8246
71148857|NCT03763877|141791494|SUPERIORITY||Mean Difference (Final Values)|-0.026|STANDARD_ERROR_OF_MEAN|0.2216||0.9067|TWO_SIDED|95.0|-0.466|0.414|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.414|-0.466|0.9067
71148858|NCT03763877|141791495|SUPERIORITY||Mean Difference (Final Values)|-0.018|STANDARD_ERROR_OF_MEAN|0.0468||0.6951|TWO_SIDED|95.0|-0.111|0.075|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.075|-0.111|0.6951
71148859|NCT03763877|141791495|SUPERIORITY||Mean Difference (Final Values)|-0.078|STANDARD_ERROR_OF_MEAN|0.0472||0.103|TWO_SIDED|95.0|-0.171|0.016|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.016|-0.171|0.1030
71148860|NCT03763877|141791495|SUPERIORITY||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.0471||0.8583|TWO_SIDED|95.0|-0.085|0.102|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.102|-0.085|0.8583
71148861|NCT03763877|141791496|SUPERIORITY||Mean Difference (Final Values)|-0.105|STANDARD_ERROR_OF_MEAN|0.1777||0.5576|TWO_SIDED|95.0|-0.457|0.248|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.248|-0.457|0.5576
71148862|NCT03763877|141791496|SUPERIORITY||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.1799||0.4261|TWO_SIDED|95.0|-0.213|0.501|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.501|-0.213|0.4261
71148863|NCT03763877|141791496|SUPERIORITY||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.1822||0.6571|TWO_SIDED|95.0|-0.281|0.443|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.443|-0.281|0.6571
71148864|NCT03763877|141791497|SUPERIORITY||Mean Difference (Final Values)|-0.161|STANDARD_ERROR_OF_MEAN|0.2851||0.5732|TWO_SIDED|95.0|-0.727|0.405|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.405|-0.727|0.5732
71148865|NCT03763877|141791497|SUPERIORITY||Mean Difference (Final Values)|-0.139|STANDARD_ERROR_OF_MEAN|0.2884||0.6312|TWO_SIDED|95.0|-0.712|0.434|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.434|-0.712|0.6312
71148866|NCT03763877|141791497|SUPERIORITY||Mean Difference (Final Values)|-0.201|STANDARD_ERROR_OF_MEAN|0.2865||0.4857|TWO_SIDED|95.0|-0.769|0.368|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.368|-0.769|0.4857
71148867|NCT03763877|141791498|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.074||0.5737|TWO_SIDED|95.0|-0.11|0.19|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||0.19|-0.11|0.5737
71148868|NCT03763877|141791498|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.074||0.7563|TWO_SIDED|95.0|-0.12|0.17|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||0.17|-0.12|0.7563
71148869|NCT03763877|141791498|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.075||0.5695|TWO_SIDED|95.0|-0.19|0.11|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||0.11|-0.19|0.5695
71148870|NCT03763877|141791499|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.659||0.9552|TWO_SIDED|95.0|-1.34|1.27|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||1.27|-1.34|0.9552
71148871|NCT03763877|141791499|SUPERIORITY||Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|0.674||0.2633|TWO_SIDED|95.0|-2.1|0.58|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.58|-2.10|0.2633
71148872|NCT03763877|141791499|SUPERIORITY||Mean Difference (Final Values)|-0.88|STANDARD_ERROR_OF_MEAN|0.673||0.1962|TWO_SIDED|95.0|-2.21|0.46|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.46|-2.21|0.1962
71148873|NCT03763877|141791500|SUPERIORITY||Odds Ratio (OR)|1.353||||0.8245|TWO_SIDED|95.0|0.094|19.554|||Regression, Logistic|||||19.554|0.094|0.8245
71148874|NCT03763877|141791500|SUPERIORITY||Odds Ratio (OR)|2.791||||0.414|TWO_SIDED|95.0|0.238|32.752|||Regression, Logistic|||||32.752|0.238|0.4140
71148875|NCT03763877|141791500|SUPERIORITY||Odds Ratio (OR)|14.872||||0.0341|TWO_SIDED|95.0|1.226|180.452|||Regression, Logistic|||||180.452|1.226|0.0341
71148876|NCT03763877|141791501|SUPERIORITY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|5.84||0.4626|TWO_SIDED|95.0|-16.1|7.5|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||7.5|-16.1|0.4626
71148877|NCT03763877|141791501|SUPERIORITY||Mean Difference (Final Values)|-6.0|STANDARD_ERROR_OF_MEAN|5.88||0.316|TWO_SIDED|95.0|-17.9|5.9|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||5.9|-17.9|0.3160
71148878|NCT03763877|141791501|SUPERIORITY||Mean Difference (Final Values)|-14.9|STANDARD_ERROR_OF_MEAN|6.19||0.0204|TWO_SIDED|95.0|-27.4|-2.4|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-2.4|-27.4|0.0204
71148879|NCT03763877|141791502|SUPERIORITY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|3.91||0.4601|TWO_SIDED|95.0|-10.8|5.0|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||5.0|-10.8|0.4601
71148880|NCT03763877|141791502|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|3.95||0.9782|TWO_SIDED|95.0|-8.1|7.9|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||7.9|-8.1|0.9782
71148881|NCT03763877|141791502|SUPERIORITY||Mean Difference (Final Values)|-9.9|STANDARD_ERROR_OF_MEAN|4.13||0.0205|TWO_SIDED|95.0|-18.3|-1.6|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-1.6|-18.3|0.0205
71148882|NCT03763877|141791503|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.538||0.9529|TWO_SIDED|95.0|-1.12|1.05|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||1.05|-1.12|0.9529
71148883|NCT03763877|141791503|SUPERIORITY||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.532||0.1285|TWO_SIDED|95.0|-1.9|0.25|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.25|-1.90|0.1285
71148884|NCT03763877|141791503|SUPERIORITY||Mean Difference (Final Values)|-1.19|STANDARD_ERROR_OF_MEAN|0.565||0.0417|TWO_SIDED|95.0|-2.32|-0.05|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-0.05|-2.32|0.0417
71148885|NCT03763877|141791504|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.228||0.3141|TWO_SIDED|95.0|-0.69|0.23|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.|||0.23|-0.69|0.3141
71148886|NCT03763877|141791504|SUPERIORITY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.226||0.0656|TWO_SIDED|95.0|-0.88|0.03|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.|||0.03|-0.88|0.0656
70875688|NCT02643082|141235219|SUPERIORITY||LS Mean ratio between treatments|0.29|||<|0.0001|TWO_SIDED|95.0|0.25|0.33|||Mixed Models Analysis|||||0.33|0.25|<0.0001
71148887|NCT03763877|141791504|SUPERIORITY||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.237||0.0101|TWO_SIDED|95.0|-1.12|-0.16|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.|||-0.16|-1.12|0.0101
71148888|NCT03537404|141791519|OTHER||Geometric Mean Ratio|0.02|||||TWO_SIDED|90.0|-0.103|0.142|||||Cmax parameters were logarithmically transformed|||0.142|-0.103|
71148889|NCT03537404|141791519|OTHER||Geometric Mean Ratio|-0.022|||||TWO_SIDED|90.0|-0.22|0.175|||||Cmax parameters were logarithmically transformed|||0.175|-0.220|
71148890|NCT03537404|141791520|OTHER||Geometric Mean Ratio|0.041|||||TWO_SIDED|90.0|-0.075|0.157|||||AUCtau parameters were logarithmically transformed.|||0.157|-0.075|
71148891|NCT03537404|141791520|OTHER||Geometric Mean Ratio|-0.069|||||TWO_SIDED|90.0|-0.201|0.064|||||AUCtau parameters were logarithmically transformed|||0.064|-0.201|
71148892|NCT03537404|141791521|OTHER||Geometric Mean Ratio|0.271|||||TWO_SIDED|90.0|0.159|0.383|||||Cmax parameters were logarithmically transformed|||0.383|0.159|
71148893|NCT03537404|141791522|OTHER||Geometric Mean Ratio|0.074|||||TWO_SIDED|90.0|0.016|0.132|||||AUCtau parameters were logarithmically transformed|||0.132|0.016|
71148894|NCT03537404|141791523|OTHER||Geometric Mean Ratio|-0.148|||||TWO_SIDED|90.0|-0.45|0.153|||||Cmax parameters were logarithmically transformed|||0.153|-0.450|
71148895|NCT03537404|141791524|OTHER||Geometric Mean Ratio|-0.093|||||TWO_SIDED|90.0|-0.354|0.168|||||AUCtau parameters were logarithmically transformed|||0.168|-0.354|
71148896|NCT00068692|141791530|SUPERIORITY|||||||0.35||||||One-sided p value was reported|Log Rank|stratified on ECOG performance status, clinical stage, timing of chemoradiotherapy, and regimen administration||||||0.35
71148897|NCT00068692|141791530|SUPERIORITY|||||||0.69||||||one-sided p value was reported|Log Rank|stratified on ECOG performance status, clinical stage, timing of chemoradiaotherapy, regimen administration||||||0.69
71148898|NCT00248040|141791551|SUPERIORITY|The model included fixed effect terms for center, time point, and treatment. Time point was specified as a repeated measurement.|Difference between means|-0.275||||0.9076|TWO_SIDED|95.0|-5.0|4.45|||Other|||This analysis refers to the 1-3 hours time point||4.45|-5.00|0.9076
71148899|NCT00248040|141791551|SUPERIORITY|The model included fixed effect terms for center, time point, and treatment. Time point was specified as a repeated measurement.|Difference between means|2.444||||0.3084|TWO_SIDED|95.0|-2.32|7.21|||Other|||This analysis refers to the 1-3 hours timepoint.||7.21|-2.32|0.3084
71148900|NCT00248040|141791551|OTHER||Difference between means|-2.719||||0.2565|TWO_SIDED|95.0|-7.47|2.03|||Other|||||2.03|-7.47|0.2565
71148901|NCT00248040|141791551|SUPERIORITY|The model included fixed effect terms for center, time point, and treatment. Time point was specified as a repeated measurement.|Difference between means|-0.063||||0.9855|TWO_SIDED|95.0|-6.91|6.79|||Other|||This analysis refers to the 10-12 hours time point.||6.79|-6.91|0.9855
71148902|NCT00248040|141791551|SUPERIORITY|The model included fixed effect terms for center, time point, and treatment. Time point was specified as a repeated measurement.|Difference between means|4.519||||0.1934|TWO_SIDED|95.0|-2.36|11.39|||Other|||This analysis refers to the 10-12 hours timepoint.||11.39|-2.36|0.1934
71148903|NCT00248040|141791551|OTHER|The model included fixed effect terms for center, time point, and treatment. Time point was specified as a repeated measurement.|Difference between means|-4.582||||0.1797|TWO_SIDED|95.0|-11.3|2.17|||Other|||This analysis refers to the 10-12 hours time point.||2.17|-11.3|0.1797
71148904|NCT02930824|141791580|SUPERIORITY|We will test the hypothesis that CYP2C19 rapid metabolizers or ultra rapid metabolizers (1 or 2 gain-of-function alleles) in the genotype-supported arm have better gastroesophageal reflux disease and symptom control than CYP2C19 rapid metabolizers or ultra rapid metabolizers in the conventional treatment group because they will have their dose increased based on their genotype.||||||0.78||||||Analysis was done of adult patients enrolled that have a CYP2C19 Rapid or Ultra-rapid metabolizer result.|t-test, 2 sided|||We will test the hypothesis that CYP2C19 rapid metabolizers or ultra rapid metabolizers (1 or 2 gain-of-function alleles) in the genotype-supported arm have better gastroesophageal reflux disease and symptom control than CYP2C19 rapid metabolizers or ultra rapid metabolizers in the conventional treatment group because they will have their dose increased based on their genotype.||||0.78
71148905|NCT02930824|141791581|SUPERIORITY|||||||0.031||||||Adjusted for baseline score, race, baseline proton pump inhibitor use, baseline histamine receptor antagonist use. A sensitivity analysis of participants only on omeprazole revealed similar findings.|Wilcoxon (Mann-Whitney)|Adjusted these end points for covariates, including the baseline score, race, and baseline medications using logistic regression||||||0.031
71148906|NCT02930824|141791582|SUPERIORITY||Hazard Ratio (HR)|2.42||||0.07|TWO_SIDED|95.0|0.9|6.3||unadjusted|Log Rank|||||6.3|0.9|0.07
71148907|NCT02930824|141791583|SUPERIORITY|||||||0.97||||||If a participant did not complete a follow-up questionnaire during their third to fifth week of proton pump inhibitor therapy, their questionnaire results were excluded from the analyses.|Wilcoxon (Mann-Whitney)|||If a participant did not complete a follow-up questionnaire during their third to fifth week of proton pump inhibitor therapy, their questionnaire results were excluded from the analyses.||||0.97
71148908|NCT02930824|141791584|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||If a participant did not complete a follow-up questionnaire during their third to fifth week of proton pump inhibitor therapy, their questionnaire results were excluded from the analyses.||||0.83
71148909|NCT02540629|141791585|EQUIVALENCE|Chi-squared test||||||0.01|||||||Chi-squared|||||||0.01
71148910|NCT01524796|141791640|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||paired Wilcoxon signed-rank test|||||||<0.001
71148911|NCT01524796|141791641|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon signed-rank test|||||||<0.001
71148912|NCT01524796|141791642|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon signed-rank test|||||||<0.001
71148913|NCT01002339|141791660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Chi-squared|||||||0.02
71148914|NCT01002339|141791661|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06|||||||Chi-squared|||||||0.06
71148915|NCT01002339|141791662|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|||||||Chi-squared|||||||0.9
71148916|NCT01002339|141791663|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07|||||||Chi-squared|||||||0.07
71148917|NCT01002339|141791664|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2|||||||ANOVA|||||||0.2
71148918|NCT01002339|141791665|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|||||||ANOVA|||||||0.4
71148919|NCT01002339|141791666|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8|||||||ANOVA|||||||0.8
71148920|NCT01002339|141791667|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56|||||||ANOVA|||||||0.56
71148921|NCT01002339|141791668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8|||||||Kruskal-Wallis|||||||0.8
71148922|NCT01002339|141791669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|||||||ANOVA|||||||0.66
71148923|NCT01002339|141791670|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|||||||ANOVA|||||||0.37
71148924|NCT01002339|141791671|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45|||||||ANOVA|||||||0.45
71148925|NCT01002339|141791672|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||ANOVA|||||||0.50
71148926|NCT01002339|141791673|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17|||||||Chi-squared|||||||0.17
71148927|NCT01002339|141791674|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||ANOVA|||||||0.5
71148928|NCT01002339|141791675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|||||||Chi-squared|||||||0.9
71148929|NCT01907854|141791676|SUPERIORITY_OR_OTHER||Treatment difference|-0.61|||<|0.0001|TWO_SIDED|95.0|-0.82|-0.4|||Mixed Models Analysis|Superiority of liraglutide over sitagliptin was concluded if the 95% Confidence Interval for the treatment difference was entirely below 0%.||Changes in HbA1c from baseline to the 26 weeks measurements were analysed using MMRM, with treatment, baseline HbA1c level (≤8.5% and \>8.5%), metformin dose (\<1500 mg/day and ≥1500 mg/day), the interaction between baseline HbA1c level and metformin dose, and country as factors and the HbA1c value at baseline as a covariate, all variables nested within week as a factor.||-0.40|-0.82|<0.0001
71148930|NCT01907854|141791677|SUPERIORITY_OR_OTHER||Treatment difference|-1.67|||<|0.0001|TWO_SIDED|95.0|-2.34|-0.99|||Mixed Models Analysis|Superiority of liraglutide over sitagliptin was concluded if the 95% Confidence Interval for the treatment difference was entirely below 0%.||Change in body weight from baseline to the 26 weeks measurements was analysed using MMRM, with treatment, baseline HbA1c level (≤8.5% and \>8.5%), metformin dose (\<1500 mg/day and ≥1500 mg/day), the interaction between baseline HbA1c level and metformin dose, and country as factors and the body weight at baseline as a covariate and all variables nested within week as a factor.||-0.99|-2.34|<0.0001
71148931|NCT02215252|141791684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_DEVIATION|0.355|||TWO_SIDED|90.0|-1.0|0.17||||||Statistical analysis is only for week 4. Mixed Models Repeated Measures analysis including all data up to Week 4 ,incorporating Bayesian priors separately on the placebo response and pregabalin effect.||0.17|-1.00|
71148932|NCT02215252|141791684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_DEVIATION|0.23|||TWO_SIDED|90.0|-0.91|-0.2||||||Statistical analysis is only for week 4. Mixed Models Repeated Measures analysis including all data up to Week 4 ,incorporating Bayesian priors separately on the placebo response and pregabalin effect.||-0.20|-0.91|
71148933|NCT02215252|141791685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91|||||TWO_SIDED|90.0|0.78|4.69||||||Statistical analysis is only for Week 4. Logistic Regression using all data up to Week 4.||4.69|0.78|
71148934|NCT02215252|141791685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.63|||||TWO_SIDED|90.0|1.06|6.56||||||Statistical analysis is only for Week 4. Logistic Regression using all data up to Week 4.||6.56|1.06|
71148935|NCT02215252|141791686|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25|||||TWO_SIDED|90.0|0.33|4.74||||||Statistical analysis is only for Week 4. Logistic Regression using all data up to Week 4.||4.74|0.33|
71148936|NCT02215252|141791686|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.75|||||TWO_SIDED|90.0|1.43|15.81||||||Statistical analysis is only for Week 4. Logistic Regression using all data up to Week 4.||15.81|1.43|
71148937|NCT02215252|141791687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|90.0|-1.75|-0.32||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||-0.32|-1.75|
71148938|NCT02215252|141791687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|90.0|-1.43|0.04||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4||0.04|-1.43|
71148939|NCT02215252|141791688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|90.0|-0.86|0.43||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4||0.43|-0.86|
71148940|NCT02215252|141791688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|90.0|-1.33|0.0||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4||0.00|-1.33|
71148941|NCT02215252|141791689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|90.0|-0.87|0.67||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||0.67|-0.87|
71148942|NCT02215252|141791689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|90.0|-1.36|0.2||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||0.20|-1.36|
71148943|NCT02215252|141791690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|90.0|-0.49|0.67||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||0.67|-0.49|
71148944|NCT02215252|141791690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-1.05|0.13||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||0.13|-1.05|
71148945|NCT02215252|141791691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|90.0|-1.09|0.39||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||0.39|-1.09|
71148946|NCT02215252|141791691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|90.0|-1.0|0.51||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||0.51|-1.00|
71148947|NCT02215252|141791692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|2.92|||TWO_SIDED|90.0|-5.12|4.57||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||4.57|-5.12|
71148948|NCT02215252|141791692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.61|STANDARD_ERROR_OF_MEAN|2.99|||TWO_SIDED|90.0|-10.57|-0.66||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||-0.66|-10.57|
71148949|NCT02215252|141791693|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||||TWO_SIDED|90.0|0.34|1.45||||||Statistical analysis is only for Week 4. Proportional Odds Logistic Regression including all data up to week 4.||1.45|0.34|
71148950|NCT02215252|141791693|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|90.0|0.24|1.07||||||Statistical analysis is only for Week 4. Proportional Odds Logistic Regression including all data up to week 4.||1.07|0.24|
71148951|NCT02215252|141791694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-1.16|-0.02||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||-0.02|-1.16|
71148952|NCT02215252|141791694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-1.57|-0.43||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||-0.43|-1.57|
71148953|NCT02215252|141791695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|192.0|STANDARD_ERROR_OF_MEAN|816.0|||TWO_SIDED|90.0|-1161.0|1544.0||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||1544|-1161|
70875689|NCT02643082|141235220|SUPERIORITY||LS Mean ratio between treatments|1.79|||<|0.0001|TWO_SIDED|95.0|1.67|1.92|||Mixed Models Analysis|||||1.92|1.67|<0.0001
70875690|NCT02643082|141235221|SUPERIORITY||LS Mean Difference Between Treatments|0.443|||<|0.0001|TWO_SIDED|95.0|0.318|0.569|||Mixed Models Analysis|||||0.569|0.318|<0.0001
70875691|NCT02643082|141235222|SUPERIORITY||LS Mean ratio between treatments|0.87|||<|0.0001|TWO_SIDED|95.0|0.82|0.92|||Mixed Models Analysis|||||0.92|0.82|<0.0001
71148954|NCT02215252|141791695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|611.0|STANDARD_ERROR_OF_MEAN|812.0|||TWO_SIDED|90.0|-735.0|1956.0||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||1956|-735|
71148955|NCT02215252|141791699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.99|STANDARD_ERROR_OF_MEAN|3.03|||TWO_SIDED|90.0|2.98|13.01||||||Statistical analysis is only for Week 4. Mixed Model Repeated Measures analysis including all data up to Week 4.||13.01|2.98|
71148956|NCT02215252|141791699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75|STANDARD_ERROR_OF_MEAN|3.14|||TWO_SIDED|90.0|-4.46|5.95||||||Statistical analysis is only for Week 4. Mixed Model Repeated Measures analysis including all data up to Week 4.||5.95|-4.46|
71148957|NCT02215252|141791700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.55|STANDARD_ERROR_OF_MEAN|5.19|||TWO_SIDED|90.0|2.94|20.17||||||Statistical analysis is only for Week 4. Mixed Model Repeated Measures analysis including all data up to Week 4.||20.17|2.94|
71148958|NCT02215252|141791700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.42|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|90.0|-11.38|6.54||||||Statistical analysis is only for Week 4. Mixed Model Repeated Measures analysis including all data up to Week 4.||6.54|-11.38|
70875692|NCT01324999|141235223|OTHER|||||||0.68|||||||t-test, 2 sided|||Comparing baseline to week 24.||||0.68
70875693|NCT01324999|141235224|OTHER|||||||0.34|||||||t-test, 2 sided|||||||0.34
70875694|NCT01324999|141235225|OTHER|||||||0.99|||||||t-test, 2 sided|||||||0.99
70875695|NCT01324999|141235226|OTHER|||||||0.19|||||||t-test, 2 sided|||comparing baseline to week 24||||0.19
71148959|NCT03397966|141791792|SUPERIORITY|||||||0.063||||||The investigators tested the effect of treatment (BNP vs. control) on the primary endpoint using mixed effects modeling, adjusting for treatment sequence, to assess the effect of treatment on each endpoint.|Mixed Models Analysis|||The primary endpoint is change in resting energy expenditure, calculated as final resting energy expenditure adjusted for baseline level, using linear regression. The null hypothesis is that there will be no significant effect of treatment on each endpoint. The investigators adhered to intention-to-treat principles. The test was performed with a significance level of 0.05.||||0.063
71148960|NCT03397966|141791793|SUPERIORITY|||||||0.07||||||Paired t-test.|t-test, 2 sided|||The null hypothesis is that there will be no significant effect of BNP on adipose gene expression of UCP1 compared with placebo. The alternative hypothesis is that UCP1 expression would be significantly higher after BNP treatment compared with placebo.||||0.07
71148961|NCT02864394|141791831|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.1276|TWO_SIDED|95.0|0.61|1.14|||Log Rank|||Treatment comparison (Hazard Ratio, HR) based on Cox regression model with Efron's method of tie handling with treatment as a covariate. One-sided p-value was based on log-rank test.||1.14|0.61|0.1276
71148962|NCT02864394|141791832|OTHER||Hazard Ratio (HR)|0.75||||0.0076|TWO_SIDED|95.0|0.6|0.95|||Log Rank|||OS was not formally tested. Treatment comparison (HR) based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by PD-L1 expression status (TPS ≥50% vs. TPS 1-49%). A nominal one-sided p-value for testing was based on log-rank test stratified by PD-L1 expression status (TPS ≥50% vs. TPS 1-49%).||0.95|0.60|0.0076
70875696|NCT01324999|141235227|OTHER|||||||0.68|||||||t-test, 2 sided|||Comparing Baseline to week 24.||||0.68
70875697|NCT01324999|141235228|OTHER|||||||0.92|||||||t-test, 2 sided|||comparing baseline to week 24||||0.92
70875698|NCT01324999|141235229|OTHER|||||||0.44|||||||t-test, 2 sided|||comparison of baseline to week 24||||0.44
70875699|NCT01862874|141235235|SUPERIORITY||Vaccine Efficacy|85.9|||<|0.001|TWO_SIDED|95.0|52.7|97.3|||One-sided exact test||Vaccine efficacy is defined as the percentage reduction in relative risk for the V501 group versus the placebo group.||If the lower bound of the 95% confidence interval for vaccine efficacy excludes 0%, then superiority of the V501 group is demonstrated.|97.3|52.7|<0.001
70875700|NCT01862874|141235236|OTHER|Statistical testing of no difference in incidence of maximum temperature ≥37.5°C|Risk Difference (RD)|-1.2||||0.256|TWO_SIDED|95.0|-3.5|0.9|||Miettinen & Nurminen||Risk difference (V501 - placebo) was estimated using the Miettinen \& Nurminen method.|||0.9|-3.5|0.256
70875701|NCT01862874|141235237|OTHER|Statistical testing of no difference in incidence of injection-site erythema|Risk Difference (RD)|2.9||||0.251|TWO_SIDED|95.0|-2.1|7.9|||Miettinen & Nurminen||Risk difference (V501 - placebo) was estimated using the Miettinen \& Nurminen method.|Injection-site erythema||7.9|-2.1|0.251
70875702|NCT01862874|141235237|OTHER|Statistical testing of no difference in incidence of injection-site pain|Risk Difference (RD)|6.4||||0.033|TWO_SIDED|95.0|0.5|12.2|||Miettinen & Nurminen||Risk difference (V501 - placebo) was estimated using the Miettinen \& Nurminen method.|Injection-site pain||12.2|0.5|0.033
70875703|NCT01862874|141235237|OTHER|Statistical testing of no difference in incidence of injection-site swelling|Risk Difference (RD)|6.8||||0.003|TWO_SIDED|95.0|2.3|11.3|||Miettinen & Nurminen||Risk difference (V501 - placebo) was estimated using the Miettinen \& Nurminen method.|Injection-site swelling||11.3|2.3|0.003
70875704|NCT01862874|141235238|OTHER|Statistical testing of no difference in incidence of systemic AEs|Risk Difference (RD)|-0.9|||||TWO_SIDED|95.0|-5.2|3.3|||||Risk difference (V501 - placebo) was estimated using the Miettinen \& Nurminen method.|||3.3|-5.2|
71148963|NCT02864394|141791833|OTHER||Hazard Ratio (HR)|0.76||||0.0534|TWO_SIDED|95.0|0.54|1.07|||Log Rank|||PFS was not formally tested. Treatment comparison (HR) based on Cox regression model with Efron's method of tie handling with treatment as a covariate. A nominal one-sided p-value for testing was based on log-rank test.||1.07|0.54|0.0534
71148964|NCT02864394|141791834|OTHER||Hazard Ratio (HR)|0.84||||0.0847|TWO_SIDED|95.0|0.66|1.08|||Log Rank|||PFS was not formally tested. Treatment comparison (HR) based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by PD-L1 expression status (TPS ≥50% vs. TPS 1-49%). A nominal one-sided p-value for testing was based on log-rank test stratified by PD-L1 expression status (TPS ≥50% vs. TPS 1-49%).||1.08|0.66|0.0847
71148965|NCT02864394|141791835|OTHER||Difference in Percentage|21.0|||<|0.0001|TWO_SIDED|95.0|11.5|30.7|||Miettinen & Nurminen Method|||ORR was not formally tested. Treatment comparison was based on the Miettinen \& Nurminen method. A nominal one-sided p-value for testing was calculated.||30.7|11.5|<0.0001
71148966|NCT02864394|141791836|OTHER||Difference in Percentage|15.0|||<|0.0001|TWO_SIDED|95.0|8.8|21.6|||Miettinen & Nurminen Method|||ORR was not formally tested. Treatment comparison was based on Miettinen \& Nurminen method stratified by PD-L1 expression status (TPS\>=50% vs. TPS 1-49%). If no participants were in one of the treatment arms involved in a comparison for a particular stratum, then that stratum was excluded from the treatment comparison. A nominal one-sided p-value for testing was calculated.||21.6|8.8|<0.0001
71148967|NCT00554216|141791854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.36|STANDARD_ERROR_OF_MEAN|0.476|<|0.0001|TWO_SIDED|95.0|8.43|10.3||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||10.30|8.43|<0.0001
71148968|NCT00554216|141791854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.54|STANDARD_ERROR_OF_MEAN|0.596|<|0.0001|TWO_SIDED|95.0|2.38|4.71||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||4.71|2.38|<0.0001
70875705|NCT01862874|141235239|OTHER|Statistical testing of no difference in incidence of vaccine-related systemic AEs|Risk Difference (RD)|-1.6|||||TWO_SIDED|95.0|-4.1|0.8|||||Risk difference (V501 - placebo) was estimated using the Miettinen \& Nurminen method.|||0.8|-4.1|
71148969|NCT00554216|141791854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.82|STANDARD_ERROR_OF_MEAN|0.596|<|0.0001|TWO_SIDED|95.0|4.65|6.99||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||6.99|4.65|<0.0001
71148970|NCT00554216|141791855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.61|STANDARD_ERROR_OF_MEAN|1.463|<|0.0001|TWO_SIDED|95.0|7.13|12.95||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||12.95|7.13|<0.0001
70875706|NCT01862874|141235240|SUPERIORITY||Vaccine Efficacy|86.5|||<|0.001|TWO_SIDED|95.0|55.2|97.4|||One-sided exact test||Vaccine efficacy is defined as the percentage reduction in relative risk for the V501 versus the placebo group.||If the lower bound of the 95% confidence interval for vaccine efficacy excludes 0%, superiority of the V501 group is demonstrated.|97.4|55.2|<0.001
70875707|NCT03178903|141235241|SUPERIORITY||Mean Difference (Final Values)|0.678||||0.87|TWO_SIDED|||||p\<.05 was the a priori threshold for statistical significance.|ANCOVA|Covarying for baseline depressive symptoms and MVPA.||||||.87
70875708|NCT04203238|141235275|SUPERIORITY||Median Difference (Final Values)|0.89|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
71148971|NCT00554216|141791855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.97|STANDARD_ERROR_OF_MEAN|0.706|<|0.0001|TWO_SIDED|95.0|2.8|5.63||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||5.63|2.80|<0.0001
71148972|NCT00554216|141791855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.42|STANDARD_ERROR_OF_MEAN|0.394|<|0.0001|TWO_SIDED|95.0|1.76|3.33||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||3.33|1.76|<0.0001
70875709|NCT04346537|141235285|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||||||< 0.001
70875710|NCT04346537|141235286|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||||||< 0.001
70875711|NCT04346537|141235287|OTHER|Two-one sided t-tests (TOST) -- the 90% confidence interval was required to be contained with 300 and 1300 ohms.|||||<|0.001|||||||Two one-sided t-tests|||||||< 0.001
70875712|NCT01134783|141235288|SUPERIORITY_OR_OTHER|||||||0.707|TWO_SIDED|||||The analysis used hierarchical linear models having repeated measures of the outcome regressed on experimental condition, adjusted for baseline age, sex, race, and household education level as well as wave and college.|Regression, Logistic|||||||0.707
70875713|NCT01134783|141235289|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED|||||The analysis used hierarchical linear models having repeated measures of the outcome regressed on experimental condition, adjusted for baseline age, sex, race, and household education level as well as wave and college.|Regression, Logistic|||||||0.049
70875714|NCT02423577|141235299|SUPERIORITY||Risk Ratio (RR)|1.14||||0.1436|TWO_SIDED|90.0|0.98|1.31|||Chi-squared|||||1.31|0.98|0.1436
70875715|NCT02392247|141235300|SUPERIORITY_OR_OTHER||Slope|0.34|||<|0.001|TWO_SIDED|95.0|0.26|0.44||This study was not designed to determine which method is 'superior'.Statistical significance refers to deviation of slope for perfect agreement (=1) between paired measurements to quantify strength of association .|Deming Regression||Slope measured deviation from 1:1 concordance between SEER and TEG with TEG measurement as denominator. Confidence intervals were obtained by bootstrapping 1000 times on the parameters estimates for the slopes, intervals and correlation coefficients|A cohort of 50 patients was estimated to capture at least 7 'bleeding' patients with a likelihood of 95%, assuming a 25% incidence of bleeding, and standard deviation of 20%, to determine maximum clot stiffness within +/- 10% of the mean. This was a descriptive and method-comparison study. Method comparisons were performed according to Clinical Laboratory Science Institute (CLSI) guidelines (Deming regression on paired measurements)||0.44|0.26|<0.001
70875716|NCT02392247|141235301|SUPERIORITY_OR_OTHER||Slope|3.1|||<|0.001|TWO_SIDED|95.0|2.9|3.4||This study was not designed to determine which method is 'superior'. Statistical significance refers to deviation of slope for perfect agreement (=1) between paired measurements to quantify strength of association .|Deming regression|Confidence intervals were obtained by bootstrapping 1000 times on the parameters estimates for the slopes, intervals and correlation coefficients|Slope measured deviation from 1:1 concordance between SEER and TEG with TEG as denominator. Confidence intervals were obtained by bootstrapping 1000 times on the parameters estimates for the slopes, intervals and correlation coefficients|A cohort of 50 patients was estimated to capture at least 7 'bleeding' patients with a likelihood of 95%, assuming a 25% incidence of bleeding, and standard deviation of 20%, to determine maximum clot stiffness within +/- 10% of the mean. This was a descriptive and method-comparison study. Method comparisons were performed according to Clinical Laboratory Science Institute (CLSI) guidelines (Deming regression on paired measurements )||3.4|2.9|<0.001
70875717|NCT02715076|141235302|OTHER||||||<|0.05|||||||mixed-effects model|||||||<0.05
71148973|NCT02633306|141791868|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
71148974|NCT02633306|141791869|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
71148975|NCT02633306|141791870|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
71148976|NCT02633306|141791871|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
70875718|NCT00106392|141235303|SUPERIORITY_OR_OTHER|||||||0.111||95.0||||P-Values were not adjusted.|Wilcoxon (Mann-Whitney)|||A group sequential design using the O'Brien and Fleming stopping rule will require 58 evaluable patients per group to detect a 5-point difference in the Erectile Function domain of the IIEF with a power of 80% and an overall significance level of 5%.||||0.111
70875719|NCT00106392|141235304|SUPERIORITY_OR_OTHER|||||||0.453||95.0|||||Fisher Exact|||||||0.453
71148977|NCT02633306|141791872|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
71148978|NCT02633306|141791873|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
71148979|NCT02633306|141791874|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
71148980|NCT00956007|141791875|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0747|TWO_SIDED|95.0|0.6|1.08||One-sided significance level = 0.0183|Log Rank|Stratified by EGFR and site/p16 status|Stratified by EGFR and site/p16 status. Reference level = IMRT.|This trial was designed to detect a hazard ratio (HR) of 0.74 with 80% statistical power and overall one-sided alpha of 0.025 (372 deaths) using a stratified log-rank test, assuming a control arm 3-year survival rate of 60.1%. The amended protocol based on ≥ 5 years potential follow-up projected 169 events, providing 55%, 66%, and 79% power to detect HRs of 0.71, 0.68, and 0.64, respectively, using the original one-sided alpha of 0.0183 the final analysis.||1.08|0.60|0.0747
71148981|NCT00956007|141791876|SUPERIORITY|||||||0.0075|||||||Fisher Exact|||Dysphagia||||0.0075
71148982|NCT00956007|141791876|SUPERIORITY|||||||0.2955|||||||Fisher Exact|||Dry mouth||||0.2955
71148983|NCT00956007|141791876|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||Dermatitis radiation||||0.0001
71148984|NCT00956007|141791876|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Rach acneiform||||<0.0001
71148985|NCT00956007|141791877|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71148986|NCT00956007|141791878|SUPERIORITY|||||||0.1641|||||||Fisher Exact|||Dysphagia||||0.1641
70875720|NCT00106392|141235305|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.790
70875721|NCT00106392|141235306|SUPERIORITY_OR_OTHER|||||||0.099||95.0|||||Fisher Exact|||||||0.099
70875722|NCT00106392|141235307|SUPERIORITY_OR_OTHER|||||||0.575||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.575
70875723|NCT00106392|141235308|SUPERIORITY_OR_OTHER|||||||0.879||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.879
70875724|NCT01500629|141235309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.156|TWO_SIDED|95.0|-1.9|0.33|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.33|-1.90|0.156
71148987|NCT00956007|141791878|SUPERIORITY|||||||0.2623|||||||Fisher Exact|||Dry mouth||||0.2623
71148988|NCT00956007|141791878|SUPERIORITY|||||||0.5378|||||||Fisher Exact|||Dermatitis radiation||||0.5378
71148989|NCT00956007|141791878|SUPERIORITY|||||||0.057|||||||Fisher Exact|||Rash acneiform||||0.0570
71148990|NCT00956007|141791879|SUPERIORITY|||||||0.1575|||||||Fisher Exact|||||||0.1575
71148991|NCT00956007|141791880|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0168|TWO_SIDED|95.0|0.57|0.98||One-sided|Log Rank|Stratified by EGFR and site/p16 status|Stratified by EGFR and site/p16 status. Reference level = IMRT.|||0.98|0.57|0.0168
71148992|NCT01746901|141791886|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|30.5|||<|0.0001|TWO_SIDED|95.0|24.4|36.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||36.6|24.4|<0.0001
71148993|NCT01746901|141791886|SUPERIORITY_OR_OTHER||LS Mean Difference|7.7||||0.0132|TWO_SIDED|95.0|1.6|13.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.7|1.6|0.0132
71148994|NCT01746901|141791886|SUPERIORITY_OR_OTHER||LS Mean Difference|15.3|||<|0.0001|TWO_SIDED|95.0|9.3|21.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.4|9.3|<0.0001
71148995|NCT01746901|141791886|SUPERIORITY_OR_OTHER||LS Mean Difference|22.9|||<|0.0001|TWO_SIDED|95.0|16.8|28.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.9|16.8|<0.0001
71148996|NCT01746901|141791886|SUPERIORITY_OR_OTHER||LS Mean Difference|15.3|||<|0.0001|TWO_SIDED|95.0|9.3|21.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.4|9.3|<0.0001
71148997|NCT01746901|141791886|SUPERIORITY_OR_OTHER||LS Mean Difference|18.5||||18.5|TWO_SIDED|95.0|12.5|24.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.6|12.5|18.5
71148998|NCT01746901|141791887|SUPERIORITY_OR_OTHER||LS Mean Difference|49.3|||<|0.0001|TWO_SIDED|95.0|39.2|59.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||59.5|39.2|<0.0001
71148999|NCT01746901|141791887|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.9994|TWO_SIDED|95.0|-10.1|10.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||10.1|-10.1|0.9994
71149000|NCT01746901|141791887|SUPERIORITY_OR_OTHER||LS Mean Difference|22.2|||<|0.0001|TWO_SIDED|95.0|12.1|32.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||32.4|12.1|<0.0001
71149001|NCT01746901|141791887|SUPERIORITY_OR_OTHER||LS Mean Difference|27.1|||<|0.0001|TWO_SIDED|95.0|17.0|37.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||37.3|17.0|<0.0001
71149002|NCT01746901|141791887|SUPERIORITY_OR_OTHER||LS Mean Difference|23.0|||<|0.0001|TWO_SIDED|95.0|12.8|33.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||33.1|12.8|<0.0001
71149003|NCT01746901|141791887|SUPERIORITY_OR_OTHER||LS Mean Difference|18.2||||0.0005|TWO_SIDED|95.0|8.1|28.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.4|8.1|0.0005
71149004|NCT01746901|141791888|SUPERIORITY_OR_OTHER||LS Mean Difference|63.2|||<|0.0001|TWO_SIDED|95.0|51.5|74.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||74.9|51.5|<0.0001
71149005|NCT01746901|141791888|SUPERIORITY_OR_OTHER||LS Mean Difference|12.3||||0.0402|TWO_SIDED|95.0|0.6|24.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.1|0.6|0.0402
71149006|NCT01746901|141791888|SUPERIORITY_OR_OTHER||LS Mean Difference|32.9|||<|0.0001|TWO_SIDED|95.0|21.1|44.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||44.7|21.1|<0.0001
71149007|NCT01746901|141791888|SUPERIORITY_OR_OTHER||LS Mean Difference|42.6|||<|0.0001|TWO_SIDED|95.0|30.9|54.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||54.4|30.9|<0.0001
71149008|NCT01746901|141791888|SUPERIORITY_OR_OTHER||LS Mean Difference|32.1|||<|0.0001|TWO_SIDED|95.0|20.3|43.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||43.9|20.3|<0.0001
71149009|NCT01746901|141791888|SUPERIORITY_OR_OTHER||LS Mean Difference|36.3|||<|0.0001|TWO_SIDED|95.0|24.6|48.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||48.1|24.6|<0.0001
71149010|NCT01746901|141791889|SUPERIORITY_OR_OTHER||LS Mean Difference|108.0|||<|0.0001|TWO_SIDED|95.0|91.6|124.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||124.5|91.6|<0.0001
71149011|NCT01746901|141791889|SUPERIORITY_OR_OTHER||LS Mean Difference|6.8||||0.4125|TWO_SIDED|95.0|-9.6|23.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||23.3|-9.6|0.4125
71149012|NCT01746901|141791889|SUPERIORITY_OR_OTHER||LS Mean Difference|46.1|||<|0.0001|TWO_SIDED|95.0|29.6|62.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||62.5|29.6|<0.0001
71149013|NCT01746901|141791889|SUPERIORITY_OR_OTHER||LS Mean Difference|68.8|||<|0.0001|TWO_SIDED|95.0|52.4|85.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||85.2|52.4|<0.0001
71149014|NCT01746901|141791889|SUPERIORITY_OR_OTHER||LS Mean Difference|56.7|||<|0.0001|TWO_SIDED|95.0|40.3|73.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||73.2|40.3|<0.0001
71149015|NCT01746901|141791889|SUPERIORITY_OR_OTHER||LS Mean Difference|52.6|||<|0.0001|TWO_SIDED|95.0|36.2|69.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||69.0|36.2|<0.0001
71149016|NCT01746901|141791890|SUPERIORITY_OR_OTHER||LS Mean Difference|32.8|||<|0.0001|TWO_SIDED|95.0|21.8|43.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||43.7|21.8|<0.0001
71149017|NCT01746901|141791890|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6||||0.6434|TWO_SIDED|95.0|-8.4|13.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.5|-8.4|0.6434
70875725|NCT01500629|141235310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.625|TWO_SIDED|95.0|-1.49|0.92|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.92|-1.49|0.625
70875726|NCT01500629|141235311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72||||0.291|TWO_SIDED|95.0|-2.12|0.67|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.67|-2.12|0.291
71149018|NCT01746901|141791890|SUPERIORITY_OR_OTHER||LS Mean Difference|9.0||||0.1072|TWO_SIDED|95.0|-2.0|20.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.0|-2.0|0.1072
71149019|NCT01746901|141791890|SUPERIORITY_OR_OTHER||LS Mean Difference|26.3|||<|0.0001|TWO_SIDED|95.0|15.4|37.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||37.3|15.4|<0.0001
71149020|NCT01746901|141791890|SUPERIORITY_OR_OTHER||LS Mean Difference|25.7|||<|0.0001|TWO_SIDED|95.0|14.7|36.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||36.6|14.7|<0.0001
71149021|NCT01746901|141791890|SUPERIORITY_OR_OTHER||LS Mean Difference|11.9||||0.0335|TWO_SIDED|95.0|0.9|22.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.9|0.9|0.0335
71149022|NCT01746901|141791891|SUPERIORITY_OR_OTHER||LS Mean Difference|35.0|||<|0.0001|TWO_SIDED|95.0|24.0|46.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||46.0|24.0|<0.0001
71149023|NCT01746901|141791891|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.9811|TWO_SIDED|95.0|-11.1|10.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||10.8|-11.1|0.9811
71149024|NCT01746901|141791891|SUPERIORITY_OR_OTHER||LS Mean Difference|9.0||||0.1083|TWO_SIDED|95.0|-2.0|19.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||19.9|-2.0|0.1083
71149025|NCT01746901|141791891|SUPERIORITY_OR_OTHER||LS Mean Difference|25.9|||<|0.0001|TWO_SIDED|95.0|14.9|36.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||36.9|14.9|<0.0001
71149026|NCT01746901|141791891|SUPERIORITY_OR_OTHER||LS Mean Difference|23.2|||<|0.0001|TWO_SIDED|95.0|12.3|34.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||34.2|12.3|<0.0001
71149027|NCT01746901|141791891|SUPERIORITY_OR_OTHER||LS Mean Difference|11.5||||0.0408|TWO_SIDED|95.0|0.5|22.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.4|0.5|0.0408
71149028|NCT01746901|141791892|SUPERIORITY_OR_OTHER||LS Mean Difference|36.9|||<|0.0001|TWO_SIDED|95.0|25.2|48.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||48.7|25.2|<0.0001
71149029|NCT01746901|141791892|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.2||||0.5968|TWO_SIDED|95.0|-14.9|8.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||8.6|-14.9|0.5968
71149030|NCT01746901|141791892|SUPERIORITY_OR_OTHER||LS Mean Difference|8.7||||0.1471|TWO_SIDED|95.0|-3.1|20.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.4|-3.1|0.1471
71149031|NCT01746901|141791892|SUPERIORITY_OR_OTHER||LS Mean Difference|9.5||||0.1136|TWO_SIDED|95.0|-2.3|21.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.3|-2.3|0.1136
71149032|NCT01746901|141791892|SUPERIORITY_OR_OTHER||LS Mean Difference|22.4||||0.0002|TWO_SIDED|95.0|10.6|34.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||34.2|10.6|0.0002
71149033|NCT01746901|141791892|SUPERIORITY_OR_OTHER||LS Mean Difference|9.5||||0.1136|TWO_SIDED|95.0|-2.3|21.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.3|-2.3|0.1136
71149034|NCT01746901|141791894|SUPERIORITY_OR_OTHER||LS Mean Difference|28.5|||<|0.0001|TWO_SIDED|95.0|19.6|37.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||37.4|19.6|<0.0001
71149035|NCT01746901|141791894|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2||||0.6209|TWO_SIDED|95.0|-6.7|11.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.1|-6.7|0.6209
71149036|NCT01746901|141791894|SUPERIORITY_OR_OTHER||LS Mean Difference|7.5||||0.0997|TWO_SIDED|95.0|-1.4|16.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.3|-1.4|0.0997
71149037|NCT01746901|141791894|SUPERIORITY_OR_OTHER||LS Mean Difference|23.2|||<|0.0001|TWO_SIDED|95.0|14.4|32.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||32.1|14.4|<0.0001
71149038|NCT01746901|141791894|SUPERIORITY_OR_OTHER||LS Mean Difference|16.6||||0.0003|TWO_SIDED|95.0|7.7|25.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||25.5|7.7|0.0003
71149039|NCT01746901|141791894|SUPERIORITY_OR_OTHER||LS Mean Difference|13.3||||0.0036|TWO_SIDED|95.0|4.4|22.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.2|4.4|0.0036
71149040|NCT01746901|141791895|SUPERIORITY_OR_OTHER||LS Mean Difference|29.9|||<|0.0001|TWO_SIDED|95.0|21.1|38.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||38.8|21.1|<0.0001
71149041|NCT01746901|141791895|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4||||0.5951|TWO_SIDED|95.0|-11.2|6.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.4|-11.2|0.5951
71149042|NCT01746901|141791895|SUPERIORITY_OR_OTHER||LS Mean Difference|7.8||||0.0841|TWO_SIDED|95.0|-1.1|16.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.6|-1.1|0.0841
71149043|NCT01746901|141791895|SUPERIORITY_OR_OTHER||LS Mean Difference|19.8|||<|0.0001|TWO_SIDED|95.0|11.0|28.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.6|11.0|<0.0001
71149044|NCT01746901|141791895|SUPERIORITY_OR_OTHER||LS Mean Difference|14.5||||0.0014|TWO_SIDED|95.0|5.7|23.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||23.4|5.7|0.0014
71149045|NCT01746901|141791895|SUPERIORITY_OR_OTHER||LS Mean Difference|10.8||||0.0172|TWO_SIDED|95.0|1.9|19.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||19.6|1.9|0.0172
71149046|NCT01746901|141791896|SUPERIORITY_OR_OTHER||LS Mean Difference|30.4|||<|0.0001|TWO_SIDED|95.0|21.0|39.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||39.9|21.0|<0.0001
71149047|NCT01746901|141791896|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.9||||0.2166|TWO_SIDED|95.0|-15.4|3.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.5|-15.4|0.2166
71149048|NCT01746901|141791896|SUPERIORITY_OR_OTHER||LS Mean Difference|8.5||||0.0777|TWO_SIDED|95.0|-1.0|18.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||18.0|-1.0|0.0777
71149049|NCT01746901|141791896|SUPERIORITY_OR_OTHER||LS Mean Difference|16.0||||0.0011|TWO_SIDED|95.0|6.5|25.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||25.4|6.5|0.0011
71149050|NCT01746901|141791896|SUPERIORITY_OR_OTHER||LS Mean Difference|12.7||||0.0086|TWO_SIDED|95.0|3.3|22.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.2|3.3|0.0086
71149051|NCT01746901|141791896|SUPERIORITY_OR_OTHER||LS Mean Difference|8.5||||0.0775|TWO_SIDED|95.0|-0.9|18.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||18.0|-0.9|0.0775
71149052|NCT01746901|141791898|SUPERIORITY_OR_OTHER||LS Mean Difference|61.2|||<|0.0001|TWO_SIDED|95.0|48.8|73.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||73.6|48.8|<0.0001
71149053|NCT01746901|141791898|SUPERIORITY_OR_OTHER||LS Mean Difference|18.8||||0.0032|TWO_SIDED|95.0|6.4|31.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||31.2|6.4|0.0032
71149054|NCT01746901|141791898|SUPERIORITY_OR_OTHER||LS Mean Difference|32.9|||<|0.0001|TWO_SIDED|95.0|20.5|45.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||45.3|20.5|<0.0001
71149055|NCT01746901|141791898|SUPERIORITY_OR_OTHER||LS Mean Difference|47.2|||<|0.0001|TWO_SIDED|95.0|34.8|59.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||59.6|34.8|<0.0001
71149056|NCT01746901|141791898|SUPERIORITY_OR_OTHER||LS Mean Difference|73.6|||<|0.0001|TWO_SIDED|95.0|61.1|86.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||86.0|61.1|<0.0001
71149057|NCT01746901|141791898|SUPERIORITY_OR_OTHER||LS Mean Difference|38.4|||<|0.0001|TWO_SIDED|95.0|26.0|50.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||50.8|26.0|<0.0001
71149058|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|43.9|||<|0.0001|TWO_SIDED|95.0|36.0|51.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||51.8|36.0|<0.0001
71149059|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3||||0.4154|TWO_SIDED|95.0|-4.6|11.2|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.2|-4.6|0.4154
71149060|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|21.8|||<|0.0001|TWO_SIDED|95.0|13.9|29.7|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||29.7|13.9|<0.0001
71149061|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|25.4|||<|0.0001|TWO_SIDED|95.0|17.5|33.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||33.3|17.5|<0.0001
71149062|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|20.2|||<|0.0001|TWO_SIDED|95.0|12.3|28.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.1|12.3|<0.0001
71149063|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|18.9|||<|0.0001|TWO_SIDED|95.0|11.0|26.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||26.8|11.0|<0.0001
71149064|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|114.2|||<|0.0001|TWO_SIDED|95.0|97.1|131.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||131.3|97.1|<0.0001
71149065|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|7.3||||0.3985|TWO_SIDED|95.0|-9.8|24.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.4|-9.8|0.3985
71149066|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|55.6|||<|0.0001|TWO_SIDED|95.0|38.5|72.8|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||72.8|38.5|<0.0001
71149067|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|65.9|||<|0.0001|TWO_SIDED|95.0|48.8|83.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||83.0|48.8|<0.0001
71149068|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|55.6|||<|0.0001|TWO_SIDED|95.0|38.5|72.7|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||72.7|38.5|<0.0001
71149069|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|54.1|||<|0.0001|TWO_SIDED|95.0|37.0|71.2|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||71.2|37.0|<0.0001
71149070|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|302.8|||<|0.0001|TWO_SIDED|95.0|248.8|356.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||356.8|248.8|<0.0001
71149071|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|47.8||||0.0824|TWO_SIDED|95.0|-6.2|101.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||101.7|-6.2|0.0824
71149072|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|188.5|||<|0.0001|TWO_SIDED|95.0|134.6|242.5|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||242.5|134.6|<0.0001
71149073|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|162.0|||<|0.0001|TWO_SIDED|95.0|108.0|216.0|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||216.0|108.0|<0.0001
71149074|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|141.9|||<|0.0001|TWO_SIDED|95.0|87.9|195.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||195.8|87.9|<0.0001
71149075|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|135.7|||<|0.0001|TWO_SIDED|95.0|81.7|189.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||189.6|81.7|<0.0001
71149076|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|287.6|||<|0.0001|TWO_SIDED|95.0|219.1|356.1|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||356.1|219.1|<0.0001
71149077|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|101.4||||0.004|TWO_SIDED|95.0|32.9|169.8|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||169.8|32.9|0.0040
70955980|NCT00548262|141415199|SUPERIORITY_OR_OTHER||percentage of participants with success|54.1|||||TWO_SIDED|95.0|38.0|70.1|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (No): Success||70.1|38.0|
71149078|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|218.5|||<|0.0001|TWO_SIDED|95.0|150.0|287.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||287.0|150.0|<0.0001
71149079|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|170.5|||<|0.0001|TWO_SIDED|95.0|102.0|239.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||239.0|102.0|<0.0001
71149080|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|158.6|||<|0.0001|TWO_SIDED|95.0|90.1|227.1|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||227.1|90.1|<0.0001
71149081|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|152.2|||<|0.0001|TWO_SIDED|95.0|83.7|220.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||220.7|83.7|<0.0001
71149082|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|185.9||||0.0002|TWO_SIDED|95.0|90.1|281.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||281.8|90.1|0.0002
71149083|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|205.0|||<|0.0001|TWO_SIDED|95.0|109.2|300.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||300.8|109.2|<0.0001
71149084|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|221.0|||<|0.0001|TWO_SIDED|95.0|125.2|316.7|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||316.7|125.2|<0.0001
71149085|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|170.0||||0.0006|TWO_SIDED|95.0|74.1|265.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||265.8|74.1|0.0006
71149086|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|185.7||||0.0002|TWO_SIDED|95.0|89.9|281.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||281.5|89.9|0.0002
71149087|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|144.9||||0.0033|TWO_SIDED|95.0|49.1|240.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||240.8|49.1|0.0033
71149088|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|170.0||||0.0017|TWO_SIDED|95.0|65.2|274.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||274.9|65.2|0.0017
71149089|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|211.4||||0.0001|TWO_SIDED|95.0|106.6|316.2|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||316.2|106.6|0.0001
71149090|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|219.2|||<|0.0001|TWO_SIDED|95.0|114.5|324.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||324.0|114.5|<0.0001
71149091|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|162.2||||0.0027|TWO_SIDED|95.0|57.3|267.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||267.0|57.3|0.0027
71149092|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|185.9||||0.0006|TWO_SIDED|95.0|81.1|290.7|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||290.7|81.1|0.0006
71149093|NCT01746901|141791899|SUPERIORITY_OR_OTHER||LS Mean Difference|135.5||||0.0116|TWO_SIDED|95.0|30.7|240.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||240.4|30.7|0.0116
71149094|NCT01746901|141791900|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.9|||<|0.0001|TWO_SIDED|95.0|-4.3|-1.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.5|-4.3|<0.0001
71149095|NCT01746901|141791900|SUPERIORITY_OR_OTHER||LS Mean Difference|2.8||||0.0001|TWO_SIDED|95.0|1.4|4.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.2|1.4|0.0001
71149096|NCT01746901|141791900|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.7005|TWO_SIDED|95.0|-1.7|1.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.1|-1.7|0.7005
71149097|NCT01746901|141791900|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.844|TWO_SIDED|95.0|-1.3|1.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.5|-1.3|0.8440
71149098|NCT01746901|141791900|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.7295|TWO_SIDED|95.0|-1.6|1.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.1|-1.6|0.7295
71149099|NCT01746901|141791900|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.8757|TWO_SIDED|95.0|-1.3|1.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.5|-1.3|0.8757
71149100|NCT01746901|141791901|SUPERIORITY_OR_OTHER||LS Mean Difference|60.1|||<|0.0001|TWO_SIDED|95.0|47.4|72.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||72.9|47.4|<0.0001
71149101|NCT01746901|141791901|SUPERIORITY_OR_OTHER||LS Mean Difference|12.6||||0.0514|TWO_SIDED|95.0|-0.1|25.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||25.4|-0.1|0.0514
71149102|NCT01746901|141791901|SUPERIORITY_OR_OTHER||LS Mean Difference|29.7|||<|0.0001|TWO_SIDED|95.0|17.0|42.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||42.4|17.0|<0.0001
71149103|NCT01746901|141791901|SUPERIORITY_OR_OTHER||LS Mean Difference|43.0|||<|0.0001|TWO_SIDED|95.0|30.3|55.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||55.8|30.3|<0.0001
71149104|NCT01746901|141791901|SUPERIORITY_OR_OTHER||LS Mean Difference|33.7|||<|0.0001|TWO_SIDED|95.0|21.0|46.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||46.4|21.0|<0.0001
71149105|NCT01746901|141791901|SUPERIORITY_OR_OTHER||LS Mean Difference|36.4|||<|0.0001|TWO_SIDED|95.0|23.7|49.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||49.1|23.7|<0.0001
71149106|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|39.5|||<|0.0001|TWO_SIDED|95.0|31.8|47.2|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||47.2|31.8|<0.0001
71149107|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3||||0.2739|TWO_SIDED|95.0|-3.4|12.0|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||12.0|-3.4|0.2739
71149108|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|16.4|||<|0.0001|TWO_SIDED|95.0|8.7|24.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.1|8.7|<0.0001
71149109|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|27.4|||<|0.0001|TWO_SIDED|95.0|19.7|35.0|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||35.0|19.7|<0.0001
71149110|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|20.5|||<|0.0001|TWO_SIDED|95.0|12.8|28.2|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.2|12.8|<0.0001
71149111|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|19.7|||<|0.0001|TWO_SIDED|95.0|12.0|27.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||27.4|12.0|<0.0001
71149112|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|104.7|||<|0.0001|TWO_SIDED|95.0|87.7|121.8|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||121.8|87.7|<0.0001
71149113|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|7.3||||0.4003|TWO_SIDED|95.0|-9.8|24.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.3|-9.8|0.4003
71149114|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|43.6|||<|0.0001|TWO_SIDED|95.0|26.6|60.7|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||60.7|26.6|<0.0001
71149115|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|68.4|||<|0.0001|TWO_SIDED|95.0|51.3|85.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||85.4|51.3|<0.0001
71149116|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|54.3|||<|0.0001|TWO_SIDED|95.0|37.3|71.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||71.4|37.3|<0.0001
71149117|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|53.0|||<|0.0001|TWO_SIDED|95.0|36.0|70.1|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||70.1|36.0|<0.0001
71149118|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|292.5|||<|0.0001|TWO_SIDED|95.0|240.0|345.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||345.1|240.0|<0.0001
71149119|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|32.2||||0.2277|TWO_SIDED|95.0|-20.3|84.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||84.7|-20.3|0.2277
71149120|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|173.1|||<|0.0001|TWO_SIDED|95.0|120.5|225.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||225.6|120.5|<0.0001
71149121|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|151.7|||<|0.0001|TWO_SIDED|95.0|99.1|204.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||204.2|99.1|<0.0001
71149122|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|129.8|||<|0.0001|TWO_SIDED|95.0|77.2|182.3|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||182.3|77.2|<0.0001
71149123|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|122.6|||<|0.0001|TWO_SIDED|95.0|70.0|175.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||175.1|70.0|<0.0001
71149124|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|295.3|||<|0.0001|TWO_SIDED|95.0|228.3|362.2|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||362.2|228.3|<0.0001
71149125|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|69.6||||0.0416|TWO_SIDED|95.0|2.7|136.5|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||136.5|2.7|0.0416
71149126|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|204.4|||<|0.0001|TWO_SIDED|95.0|137.5|271.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||271.3|137.5|<0.0001
70955981|NCT00548262|141415199|SUPERIORITY_OR_OTHER||percentage of participants with success|46.5|||||TWO_SIDED|95.0|31.6|61.4|||||95% CI based on normal approximation to the binomial.|Chemotherapy (No): Success||61.4|31.6|
71149127|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|160.5|||<|0.0001|TWO_SIDED|95.0|93.5|227.4|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||227.4|93.5|<0.0001
71149128|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|133.0||||0.0001|TWO_SIDED|95.0|66.1|199.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||199.9|66.1|0.0001
71149129|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|140.1|||<|0.0001|TWO_SIDED|95.0|73.1|207.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||207.0|73.1|<0.0001
71149130|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|219.5|||<|0.0001|TWO_SIDED|95.0|127.6|311.3|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||311.3|127.6|<0.0001
71149131|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|145.0||||0.0022|TWO_SIDED|95.0|53.2|236.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||236.8|53.2|0.0022
71149132|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|200.2|||<|0.0001|TWO_SIDED|95.0|108.4|292.0|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||292.0|108.4|<0.0001
71149133|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|164.3||||0.0005|TWO_SIDED|95.0|72.4|256.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||256.1|72.4|0.0005
71149134|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|146.6||||0.0019|TWO_SIDED|95.0|54.8|238.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||238.4|54.8|0.0019
71149135|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|132.7||||0.0049|TWO_SIDED|95.0|40.8|224.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||224.5|40.8|0.0049
71149136|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|209.3|||<|0.0001|TWO_SIDED|95.0|108.3|310.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||310.3|108.3|<0.0001
71149137|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|145.7||||0.005|TWO_SIDED|95.0|44.7|246.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||246.6|44.7|0.0050
71149138|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|200.7||||0.0001|TWO_SIDED|95.0|99.7|301.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||301.6|99.7|0.0001
71149139|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|154.3||||0.003|TWO_SIDED|95.0|53.3|255.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||255.3|53.3|0.0030
71149140|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|146.8||||0.0046|TWO_SIDED|95.0|45.9|247.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||247.8|45.9|0.0046
71149141|NCT01746901|141791902|SUPERIORITY_OR_OTHER||LS Mean Difference|123.3||||0.0171|TWO_SIDED|95.0|22.3|224.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||224.3|22.3|0.0171
71149142|NCT01746901|141791903|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3||||0.0016|TWO_SIDED|95.0|-3.7|-0.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.9|-3.7|0.0016
71149143|NCT01746901|141791903|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9||||0.0105|TWO_SIDED|95.0|0.4|3.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.3|0.4|0.0105
71149144|NCT01746901|141791903|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.7259|TWO_SIDED|95.0|-1.7|1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.2|-1.7|0.7259
71149145|NCT01746901|141791903|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.7813|TWO_SIDED|95.0|-1.6|1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.2|-1.6|0.7813
71149146|NCT01746901|141791903|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.5235|TWO_SIDED|95.0|-1.9|1.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.0|-1.9|0.5235
71149147|NCT01746901|141791903|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.8512|TWO_SIDED|95.0|-1.6|1.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.3|-1.6|0.8512
71149148|NCT01746901|141791904|SUPERIORITY_OR_OTHER||LS Mean Difference|11.1||||0.0883|TWO_SIDED|95.0|-1.7|23.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||23.9|-1.7|0.0883
71149149|NCT01746901|141791904|SUPERIORITY_OR_OTHER||LS Mean Difference|14.8||||0.0241|TWO_SIDED|95.0|2.0|27.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||27.6|2.0|0.0241
71149150|NCT01746901|141791904|SUPERIORITY_OR_OTHER||LS Mean Difference|14.8||||0.0235|TWO_SIDED|95.0|2.0|27.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||27.6|2.0|0.0235
71149151|NCT01746901|141791904|SUPERIORITY_OR_OTHER||LS Mean Difference|11.1||||0.0901|TWO_SIDED|95.0|-1.7|23.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||23.9|-1.7|0.0901
71149152|NCT01746901|141791904|SUPERIORITY_OR_OTHER||LS Mean Difference|9.8||||0.1313|TWO_SIDED|95.0|-3.0|22.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.6|-3.0|0.1313
71149153|NCT01746901|141791904|SUPERIORITY_OR_OTHER||LS Mean Difference|10.8||||0.0982|TWO_SIDED|95.0|-2.0|23.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||23.6|-2.0|0.0982
71149154|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3||||0.0351|TWO_SIDED|95.0|0.2|6.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.3|0.2|0.0351
71149155|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.8751|TWO_SIDED|95.0|-3.3|2.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.8|-3.3|0.8751
71149156|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7||||0.0795|TWO_SIDED|95.0|-0.3|5.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||5.8|-0.3|0.0795
71149157|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.8382|TWO_SIDED|95.0|-2.7|3.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.4|-2.7|0.8382
71149158|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4||||0.0289|TWO_SIDED|95.0|0.4|6.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.4|0.4|0.0289
71149159|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.7878|TWO_SIDED|95.0|-2.6|3.5|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.5|-2.6|0.7878
71149160|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|14.8||||0.0019|TWO_SIDED|95.0|5.6|24.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.0|5.6|0.0019
71149161|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1||||0.821|TWO_SIDED|95.0|-8.1|10.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||10.3|-8.1|0.821
71149162|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|12.3||||0.0094|TWO_SIDED|95.0|3.1|21.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.5|3.1|0.0094
71149163|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|3.6||||0.4454|TWO_SIDED|95.0|-5.6|12.8|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||12.8|-5.6|0.4454
71149164|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|7.9||||0.0934|TWO_SIDED|95.0|-1.3|17.1|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||17.1|-1.3|0.0934
71149165|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|7.0||||0.1358|TWO_SIDED|95.0|-2.2|16.2|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.2|-2.2|0.1358
71149166|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|59.8||||0.0004|TWO_SIDED|95.0|27.0|92.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||92.7|27.0|0.0004
71149167|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|19.7||||0.2365|TWO_SIDED|95.0|-13.1|52.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||52.6|-13.1|0.2365
71149168|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|43.9||||0.0091|TWO_SIDED|95.0|11.1|76.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||76.7|11.1|0.0091
71149169|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|35.7||||0.0335|TWO_SIDED|95.0|2.8|68.5|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||68.5|2.8|0.0335
70955982|NCT00548262|141415199|SUPERIORITY_OR_OTHER||percentage of participants with success|40.0|||||TWO_SIDED|95.0|0.0|82.9|||||95% CI based on normal approximation to the binomial.|Pancreatitis (Yes): Success||82.9|0.0|
71149170|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|30.8||||0.0661|TWO_SIDED|95.0|-2.1|63.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||63.6|-2.1|0.0661
71149171|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|26.9||||0.1074|TWO_SIDED|95.0|-5.9|59.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||59.8|-5.9|0.1074
71149172|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|55.3||||0.0064|TWO_SIDED|95.0|15.8|94.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||94.9|15.8|0.0064
71149173|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|38.8||||0.0543|TWO_SIDED|95.0|-0.7|78.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||78.3|-0.7|0.0543
71149174|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|50.2||||0.0131|TWO_SIDED|95.0|10.7|89.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||89.7|10.7|0.0131
71149175|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|43.9||||0.0297|TWO_SIDED|95.0|4.4|83.5|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||83.5|4.4|0.0297
71149176|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|41.3||||0.0407|TWO_SIDED|95.0|1.8|80.8|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||80.8|1.8|0.0407
71149177|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|27.5||||0.171|TWO_SIDED|95.0|-12.0|67.1|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||67.1|-12.0|0.1710
71149178|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.0||||0.3362|TWO_SIDED|95.0|-106.7|36.7|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||36.7|-106.7|0.3362
71149179|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|126.9||||0.0006|TWO_SIDED|95.0|55.2|198.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||198.5|55.2|0.0006
71149180|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|53.2||||0.1449|TWO_SIDED|95.0|-18.5|124.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||124.8|-18.5|0.1449
71149181|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|38.7||||0.2882|TWO_SIDED|95.0|-33.0|110.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||110.4|-33.0|0.2882
71149182|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|55.0||||0.1314|TWO_SIDED|95.0|-16.6|126.7|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||126.7|-16.6|0.1314
71149183|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|20.1||||0.5808|TWO_SIDED|95.0|-51.6|91.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||91.8|-51.6|0.5808
71149184|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|-66.2||||0.1415|TWO_SIDED|95.0|-154.6|22.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.3|-154.6|0.1415
71149185|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|149.1||||0.0011|TWO_SIDED|95.0|60.7|237.5|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||237.5|60.7|0.0011
71149186|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|52.5||||0.2423|TWO_SIDED|95.0|-35.9|140.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||140.9|-35.9|0.2423
71149187|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|30.4||||0.498|TWO_SIDED|95.0|-58.0|118.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||118.8|-58.0|0.4980
71149188|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|54.5||||0.2253|TWO_SIDED|95.0|-33.9|142.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||142.9|-33.9|0.2253
71149189|NCT01746901|141791905|SUPERIORITY_OR_OTHER||LS Mean Difference|11.7||||0.7945|TWO_SIDED|95.0|-76.8|100.1|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||100.1|-76.8|0.7945
71149190|NCT01746901|141791906|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8||||0.0129|TWO_SIDED|95.0|-5.1|-0.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.6|-5.1|0.0129
70875727|NCT01500629|141235312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.899|TWO_SIDED|95.0|-1.21|1.07|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||1.07|-1.21|0.899
71149191|NCT01746901|141791906|SUPERIORITY_OR_OTHER||LS Mean Difference|4.2||||0.0003|TWO_SIDED|95.0|2.0|6.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.5|2.0|0.0003
71149192|NCT01746901|141791906|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.5483|TWO_SIDED|95.0|-1.6|2.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.9|-1.6|0.5483
71149193|NCT01746901|141791906|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.5284|TWO_SIDED|95.0|-1.5|2.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.9|-1.5|0.5284
71149194|NCT01746901|141791906|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.1331|TWO_SIDED|95.0|-0.5|3.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.9|-0.5|0.1331
71149195|NCT01746901|141791906|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.8732|TWO_SIDED|95.0|-2.1|2.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.4|-2.1|0.8732
71149196|NCT01746901|141791907|SUPERIORITY_OR_OTHER||LS Mean Difference|3.6||||0.4555|TWO_SIDED|95.0|-5.9|13.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.2|-5.9|0.4555
71149197|NCT01746901|141791907|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9||||0.1495|TWO_SIDED|95.0|-2.5|16.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.4|-2.5|0.1495
71149198|NCT01746901|141791907|SUPERIORITY_OR_OTHER||LS Mean Difference|11.4||||0.02|TWO_SIDED|95.0|1.8|20.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.9|1.8|0.0200
71149199|NCT01746901|141791907|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8||||0.8668|TWO_SIDED|95.0|-10.3|8.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||8.7|-10.3|0.8668
70955983|NCT00548262|141415199|SUPERIORITY_OR_OTHER||percentage of participants with success|48.7|||||TWO_SIDED|95.0|33.0|64.4|||||95% CI based on normal approximation to the binomial.|Pancreatitis (No): Success||64.4|33.0|
71149200|NCT01746901|141791907|SUPERIORITY_OR_OTHER||LS Mean Difference|4.1||||0.3904|TWO_SIDED|95.0|-5.3|13.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.6|-5.3|0.3904
71149201|NCT01746901|141791907|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2||||0.6524|TWO_SIDED|95.0|-7.3|11.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.6|-7.3|0.6524
71149202|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8||||0.1771|TWO_SIDED|95.0|-0.4|2.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.1|-0.4|0.1771
71149203|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.3944|TWO_SIDED|95.0|-1.7|0.7|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||0.7|-1.7|0.3944
71149204|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8||||0.1778|TWO_SIDED|95.0|-0.4|2.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.1|-0.4|0.1778
71149205|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.396|TWO_SIDED|95.0|-1.7|0.7|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||0.7|-1.7|0.3960
70875728|NCT01500629|141235313|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.701||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.701
71149206|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.6125|TWO_SIDED|95.0|-0.9|1.5|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.5|-0.9|0.6125
71149207|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.9059|TWO_SIDED|95.0|-1.1|1.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.3|-1.1|0.9059
71149208|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.4585|TWO_SIDED|95.0|-2.9|6.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.3|-2.9|0.4585
71149209|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.8986|TWO_SIDED|95.0|-4.2|4.8|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.8|-4.2|0.8986
71149210|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1||||0.3641|TWO_SIDED|95.0|-2.5|6.7|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.7|-2.5|0.3641
71149211|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.9674|TWO_SIDED|95.0|-4.6|4.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.4|-4.6|0.9674
70875729|NCT01500629|141235314|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.108||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.108
71149212|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3||||0.5744|TWO_SIDED|95.0|-3.2|5.8|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||5.8|-3.2|0.5744
71149213|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2||||0.3457|TWO_SIDED|95.0|-2.4|6.7|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.7|-2.4|0.3457
71149214|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|3.7||||0.6664|TWO_SIDED|95.0|-13.3|20.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.8|-13.3|0.6664
71149215|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|11.1||||0.1949|TWO_SIDED|95.0|-5.8|28.0|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.0|-5.8|0.1949
71149216|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|11.1||||0.2009|TWO_SIDED|95.0|-6.0|28.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.1|-6.0|0.2009
71149217|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|3.8||||0.6595|TWO_SIDED|95.0|-13.1|20.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.7|-13.1|0.6595
71149218|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|8.6||||0.3176|TWO_SIDED|95.0|-8.3|25.5|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||25.5|-8.3|0.3176
71149219|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|4.0||||0.6423|TWO_SIDED|95.0|-12.9|20.9|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.9|-12.9|0.6423
71149220|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|6.8||||0.4358|TWO_SIDED|95.0|-10.5|24.2|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.2|-10.5|0.4358
71149221|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|11.7||||0.1789|TWO_SIDED|95.0|-5.4|28.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.9|-5.4|0.1789
71149222|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|14.0||||0.1131|TWO_SIDED|95.0|-3.3|31.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||31.3|-3.3|0.1131
71149223|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|4.6||||0.5965|TWO_SIDED|95.0|-12.6|21.8|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.8|-12.6|0.5965
71149224|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|8.7||||0.3175|TWO_SIDED|95.0|-8.5|25.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||25.9|-8.5|0.3175
71149225|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|3.9||||0.6551|TWO_SIDED|95.0|-13.3|21.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.0|-13.3|0.6551
71149226|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.3||||0.0354|TWO_SIDED|95.0|-87.5|-3.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-3.1|-87.5|0.0354
71149227|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|55.2||||0.01|TWO_SIDED|95.0|13.4|97.0|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||97.0|13.4|0.0100
71149228|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|13.2||||0.5379|TWO_SIDED|95.0|-29.0|55.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||55.4|-29.0|0.5379
71149229|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.3||||0.8768|TWO_SIDED|95.0|-45.1|38.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||38.5|-45.1|0.8768
71149230|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|8.1||||0.7031|TWO_SIDED|95.0|-33.8|49.9|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||49.9|-33.8|0.7031
71149231|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.0||||0.8507|TWO_SIDED|95.0|-45.8|37.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||37.8|-45.8|0.8507
71149232|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|-62.3||||0.0381|TWO_SIDED|95.0|-121.2|-3.5|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-3.5|-121.2|0.0381
71149233|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|64.0||||0.0318|TWO_SIDED|95.0|5.7|122.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||122.3|5.7|0.0318
71149234|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|15.2||||0.6095|TWO_SIDED|95.0|-43.6|74.1|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||74.1|-43.6|0.6095
71149235|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.6||||0.647|TWO_SIDED|95.0|-71.9|44.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||44.8|-71.9|0.6470
71149236|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|7.0||||0.8136|TWO_SIDED|95.0|-51.4|65.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||65.4|-51.4|0.8136
71149237|NCT01746901|141791908|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.6||||0.6699|TWO_SIDED|95.0|-71.0|45.7|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||45.7|-71.0|0.6699
71149238|NCT01746901|141791909|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6||||0.1728|TWO_SIDED|95.0|-3.9|0.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||0.7|-3.9|0.1728
71149239|NCT01746901|141791909|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3||||0.2616|TWO_SIDED|95.0|-1.0|3.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.6|-1.0|0.2616
71149240|NCT01746901|141791909|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.7307|TWO_SIDED|95.0|-1.9|2.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.7|-1.9|0.7307
71149241|NCT01746901|141791909|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.5473|TWO_SIDED|95.0|-3.0|1.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.6|-3.0|0.5473
70875730|NCT01500629|141235315|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0||||0.253||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.253
70875731|NCT01500629|141235316|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.287||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.287
70875732|NCT01500629|141235317|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.409||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.409
70875733|NCT01500629|141235318|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.092||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.092
70955984|NCT00548262|141415199|SUPERIORITY_OR_OTHER||percentage of participants with success|41.7|||||TWO_SIDED|95.0|13.8|69.6|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (Yes): Success||69.6|13.8|
71149242|NCT01746901|141791909|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8||||0.4999|TWO_SIDED|95.0|-3.1|1.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.5|-3.1|0.4999
71149243|NCT01746901|141791909|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.5592|TWO_SIDED|95.0|-3.0|1.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.6|-3.0|0.5592
71149244|NCT01746901|141791910|SUPERIORITY_OR_OTHER||LS Mean Difference|13.3||||0.0217|TWO_SIDED|95.0|2.0|24.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.6|2.0|0.0217
71149245|NCT01746901|141791910|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4||||0.5513|TWO_SIDED|95.0|-7.8|14.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||14.6|-7.8|0.5513
71149246|NCT01746901|141791910|SUPERIORITY_OR_OTHER||LS Mean Difference|11.5||||0.0469|TWO_SIDED|95.0|0.2|22.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.8|0.2|0.0469
71149247|NCT01746901|141791910|SUPERIORITY_OR_OTHER||LS Mean Difference|5.2||||0.3604|TWO_SIDED|95.0|-6.0|16.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.4|-6.0|0.3604
71149248|NCT01746901|141791910|SUPERIORITY_OR_OTHER||LS Mean Difference|6.2||||0.2725|TWO_SIDED|95.0|-5.0|17.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||17.4|-5.0|0.2725
71149249|NCT01746901|141791910|SUPERIORITY_OR_OTHER||LS Mean Difference|5.4||||0.3461|TWO_SIDED|95.0|-5.8|16.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.6|-5.8|0.3461
71149250|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4||||0.1828|TWO_SIDED|95.0|-1.1|5.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||5.8|-1.1|0.1828
71149251|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5||||0.3908|TWO_SIDED|95.0|-5.0|1.9|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.9|-5.0|0.3908
71149252|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0||||0.2513|TWO_SIDED|95.0|-1.5|5.5|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||5.5|-1.5|0.2513
71149253|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.2||||0.5035|TWO_SIDED|95.0|-4.6|2.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.3|-4.6|0.5035
71149254|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6||||0.1452|TWO_SIDED|95.0|-0.9|6.0|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.0|-0.9|0.1452
71149255|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.9303|TWO_SIDED|95.0|-3.6|3.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.3|-3.6|0.9303
71149256|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|8.8||||0.0283|TWO_SIDED|95.0|0.9|16.7|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.7|0.9|0.0283
71149257|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7||||0.4861|TWO_SIDED|95.0|-10.5|5.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||5.0|-10.5|0.4861
71149258|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|5.3||||0.1809|TWO_SIDED|95.0|-2.5|13.2|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.2|-2.5|0.1809
71149259|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.856|TWO_SIDED|95.0|-7.1|8.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||8.5|-7.1|0.8560
71149260|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|4.7||||0.2385|TWO_SIDED|95.0|-3.1|12.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||12.4|-3.1|0.2385
71149261|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|3.7||||0.3479|TWO_SIDED|95.0|-4.1|11.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.5|-4.1|0.3479
71149262|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|27.7||||0.0185|TWO_SIDED|95.0|4.7|50.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||50.6|4.7|0.0185
71149263|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9||||0.5471|TWO_SIDED|95.0|-15.8|29.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||29.7|-15.8|0.5471
71149264|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|24.5||||0.0367|TWO_SIDED|95.0|1.5|47.4|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||47.4|1.5|0.0367
71149265|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|10.1||||0.3797|TWO_SIDED|95.0|-12.6|32.9|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||32.9|-12.6|0.3797
71149266|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|16.4||||0.1557|TWO_SIDED|95.0|-6.3|39.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||39.1|-6.3|0.1557
71149267|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|12.2||||0.2904|TWO_SIDED|95.0|-10.5|34.9|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||34.9|-10.5|0.2904
71149268|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|26.0||||0.0467|TWO_SIDED|95.0|0.4|51.6|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||51.6|0.4|0.0467
71149269|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|10.7||||0.4056|TWO_SIDED|95.0|-14.6|36.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||36.0|-14.6|0.4056
71149270|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|23.3||||0.0738|TWO_SIDED|95.0|-2.3|48.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||48.9|-2.3|0.0738
71149271|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|13.4||||0.2987|TWO_SIDED|95.0|-12.0|38.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||38.7|-12.0|0.2987
71149272|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|22.9||||0.0763|TWO_SIDED|95.0|-2.4|48.2|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||48.2|-2.4|0.0763
71149273|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|12.3||||0.3396|TWO_SIDED|95.0|-13.1|37.6|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||37.6|-13.1|0.3396
71149274|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.2||||0.2425|TWO_SIDED|95.0|-89.1|22.7|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.7|-89.1|0.2425
71149275|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|62.1||||0.0281|TWO_SIDED|95.0|6.8|117.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||117.5|6.8|0.0281
71149276|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|22.9||||0.4189|TWO_SIDED|95.0|-33.0|78.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||78.8|-33.0|0.4189
71149277|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|6.0||||0.831|TWO_SIDED|95.0|-49.4|61.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||61.4|-49.4|0.8310
71149278|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|34.8||||0.2161|TWO_SIDED|95.0|-20.6|90.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||90.1|-20.6|0.2161
71149279|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|3.9||||0.8905|TWO_SIDED|95.0|-51.5|59.2|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||59.2|-51.5|0.8905
71149280|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.8||||0.1597|TWO_SIDED|95.0|-124.2|20.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.6|-124.2|0.1597
71149281|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|70.9||||0.0525|TWO_SIDED|95.0|-0.8|142.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||142.6|-0.8|0.0525
71149282|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|23.1||||0.5294|TWO_SIDED|95.0|-49.3|95.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||95.4|-49.3|0.5294
70875734|NCT01500629|141235319|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0||||0.042||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.042
71149283|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.0||||0.9126|TWO_SIDED|95.0|-75.7|67.7|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||67.7|-75.7|0.9126
71149284|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|34.6||||0.3418|TWO_SIDED|95.0|-37.1|106.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||106.3|-37.1|0.3418
71149285|NCT01746901|141791911|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.3||||0.8833|TWO_SIDED|95.0|-77.0|66.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||66.4|-77.0|0.8833
71149286|NCT01746901|141791912|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.6||||0.0041|TWO_SIDED|95.0|-6.1|-1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.2|-6.1|0.0041
71149287|NCT01746901|141791912|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3||||0.0006|TWO_SIDED|95.0|1.9|6.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.8|1.9|0.0006
71149288|NCT01746901|141791912|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.8765|TWO_SIDED|95.0|-2.7|2.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.3|-2.7|0.8765
71149289|NCT01746901|141791912|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9||||0.4746|TWO_SIDED|95.0|-1.6|3.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.3|-1.6|0.4746
71149290|NCT01746901|141791912|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9||||0.4607|TWO_SIDED|95.0|-3.3|1.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.5|-3.3|0.4607
71149291|NCT01746901|141791912|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5||||0.2316|TWO_SIDED|95.0|-1.0|3.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.9|-1.0|0.2316
71149292|NCT01746901|141791913|SUPERIORITY_OR_OTHER||LS Mean Difference|38.8|||<|0.0001|TWO_SIDED|95.0|26.4|51.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||51.3|26.4|<0.0001
71149293|NCT01746901|141791913|SUPERIORITY_OR_OTHER||LS Mean Difference|15.8||||0.0136|TWO_SIDED|95.0|3.3|28.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.3|3.3|0.0136
71149294|NCT01746901|141791913|SUPERIORITY_OR_OTHER||LS Mean Difference|18.5||||0.0039|TWO_SIDED|95.0|6.1|31.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||31.0|6.1|0.0039
71149295|NCT01746901|141791913|SUPERIORITY_OR_OTHER||LS Mean Difference|36.1|||<|0.0001|TWO_SIDED|95.0|23.6|48.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||48.5|23.6|<0.0001
71149296|NCT01746901|141791913|SUPERIORITY_OR_OTHER||LS Mean Difference|15.4||||0.0157|TWO_SIDED|95.0|2.9|27.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||27.8|2.9|0.0157
71149297|NCT01746901|141791913|SUPERIORITY_OR_OTHER||LS Mean Difference|32.9|||<|0.0001|TWO_SIDED|95.0|20.5|45.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||45.3|20.5|<0.0001
70875735|NCT01500629|141235320|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.307||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.307
71149298|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|12.5|||<|0.0001|TWO_SIDED|95.0|6.4|18.6|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||18.6|6.4|<0.0001
71149299|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5||||0.255|TWO_SIDED|95.0|-2.6|9.6|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||9.6|-2.6|0.2550
71149300|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|10.4||||0.001|TWO_SIDED|95.0|4.3|16.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.4|4.3|0.0010
71149301|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|5.7||||0.0667|TWO_SIDED|95.0|-0.4|11.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.8|-0.4|0.0667
71149302|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|8.3||||0.0075|TWO_SIDED|95.0|2.3|14.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||14.4|2.3|0.0075
71149303|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|4.6||||0.1354|TWO_SIDED|95.0|-1.5|10.7|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||10.7|-1.5|0.1354
71149304|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|50.9|||<|0.0001|TWO_SIDED|95.0|34.2|67.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||67.5|34.2|<0.0001
71149305|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|7.3||||0.3905|TWO_SIDED|95.0|-9.4|24.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.0|-9.4|0.3905
71149306|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|28.6||||0.0009|TWO_SIDED|95.0|11.9|45.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||45.3|11.9|0.0009
71149307|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|29.6||||0.0006|TWO_SIDED|95.0|12.9|46.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||46.3|12.9|0.0006
70955985|NCT00548262|141415199|SUPERIORITY_OR_OTHER||percentage of participants with success|50.0|||||TWO_SIDED|95.0|32.7|67.3|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (No): Success||67.3|32.7|
71149308|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|22.9||||0.0072|TWO_SIDED|95.0|6.3|39.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||39.5|6.3|0.0072
71149309|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|25.0||||0.0035|TWO_SIDED|95.0|8.4|41.6|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||41.6|8.4|0.0035
71149310|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|248.4|||<|0.0001|TWO_SIDED|95.0|188.6|308.3|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||308.3|188.6|<0.0001
71149311|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|68.2||||0.0263|TWO_SIDED|95.0|8.2|128.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||128.2|8.2|0.0263
71149312|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|151.2|||<|0.0001|TWO_SIDED|95.0|91.3|211.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||211.1|91.3|<0.0001
71149313|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|165.4|||<|0.0001|TWO_SIDED|95.0|105.6|225.3|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||225.3|105.6|<0.0001
71149314|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|97.9||||0.0015|TWO_SIDED|95.0|38.3|157.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||157.6|38.3|0.0015
71149315|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|138.4|||<|0.0001|TWO_SIDED|95.0|78.7|198.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||198.2|78.7|<0.0001
71149316|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|241.3|||<|0.0001|TWO_SIDED|95.0|162.8|319.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||319.9|162.8|<0.0001
71149317|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|121.1||||0.0028|TWO_SIDED|95.0|42.4|199.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||199.9|42.4|0.0028
71149318|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|164.4|||<|0.0001|TWO_SIDED|95.0|85.8|243.1|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||243.1|85.8|<0.0001
70875736|NCT01500629|141235321|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.5||||0.903||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.903
70955986|NCT00548262|141415199|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Neutropenic: Success||100.0|13.3|
71149319|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|198.0|||<|0.0001|TWO_SIDED|95.0|119.4|276.6|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||276.6|119.4|<0.0001
71149320|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|111.1||||0.0057|TWO_SIDED|95.0|32.8|189.4|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||189.4|32.8|0.0057
71149321|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|168.1|||<|0.0001|TWO_SIDED|95.0|89.7|246.6|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||246.6|89.7|<0.0001
71149322|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|128.4||||0.036|TWO_SIDED|95.0|8.5|248.3|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||248.3|8.5|0.0360
71149323|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|221.5||||0.0004|TWO_SIDED|95.0|101.2|341.7|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||341.7|101.2|0.0004
71149324|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|126.7||||0.0388|TWO_SIDED|95.0|6.6|246.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||246.8|6.6|0.0388
71149325|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|223.2||||0.0003|TWO_SIDED|95.0|103.2|343.2|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||343.2|103.2|0.0003
71149326|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|107.2||||0.0787|TWO_SIDED|95.0|-12.4|226.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||226.8|-12.4|0.0787
71149327|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|181.3||||0.0033|TWO_SIDED|95.0|61.5|301.0|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||301.0|61.5|0.0033
71149328|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|96.1||||0.1688|TWO_SIDED|95.0|-41.2|233.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||233.3|-41.2|0.1688
71149329|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|220.3||||0.0019|TWO_SIDED|95.0|82.6|358.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||358.0|82.6|0.0019
71149330|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|106.0||||0.1298|TWO_SIDED|95.0|-31.5|243.5|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||243.5|-31.5|0.1298
71149331|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|210.4||||0.0029|TWO_SIDED|95.0|73.0|347.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||347.8|73.0|0.0029
71149332|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|108.7||||0.1189|TWO_SIDED|95.0|-28.3|245.7|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||245.7|-28.3|0.1189
71149333|NCT01746901|141791914|SUPERIORITY_OR_OTHER||LS Mean Difference|153.6||||0.0284|TWO_SIDED|95.0|16.4|290.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||290.8|16.4|0.0284
71149334|NCT01746901|141791915|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8||||0.0327|TWO_SIDED|95.0|-3.4|-0.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.1|-3.4|0.0327
70875737|NCT01500629|141235322|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.121||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.121
71149335|NCT01746901|141791915|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6||||0.0019|TWO_SIDED|95.0|1.0|4.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.2|1.0|0.0019
71149336|NCT01746901|141791915|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.7508|TWO_SIDED|95.0|-1.9|1.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.4|-1.9|0.7508
71149337|NCT01746901|141791915|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1||||0.1868|TWO_SIDED|95.0|-0.5|2.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.7|-0.5|0.1868
71149338|NCT01746901|141791915|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.9944|TWO_SIDED|95.0|-1.6|1.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.6|-1.6|0.9944
71149339|NCT01746901|141791915|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0||||0.2322|TWO_SIDED|95.0|-0.6|2.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.6|-0.6|0.2322
71149340|NCT01746901|141791916|SUPERIORITY_OR_OTHER||LS Mean Difference|28.2|||<|0.0001|TWO_SIDED|95.0|16.8|39.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||39.6|16.8|<0.0001
71149341|NCT01746901|141791916|SUPERIORITY_OR_OTHER||LS Mean Difference|8.4||||0.1421|TWO_SIDED|95.0|-2.8|19.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||19.6|-2.8|0.1421
71149342|NCT01746901|141791916|SUPERIORITY_OR_OTHER||LS Mean Difference|20.9||||0.0004|TWO_SIDED|95.0|9.5|32.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||32.2|9.5|0.0004
71149343|NCT01746901|141791916|SUPERIORITY_OR_OTHER||LS Mean Difference|15.8||||0.0064|TWO_SIDED|95.0|4.5|27.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||27.0|4.5|0.0064
71149344|NCT01746901|141791916|SUPERIORITY_OR_OTHER||LS Mean Difference|7.4||||0.1974|TWO_SIDED|95.0|-3.9|18.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||18.6|-3.9|0.1974
71149345|NCT01746901|141791916|SUPERIORITY_OR_OTHER||LS Mean Difference|19.5||||0.0008|TWO_SIDED|95.0|8.3|30.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||30.8|8.3|0.0008
71149346|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|12.2|||<|0.0001|TWO_SIDED|95.0|7.1|17.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||17.4|7.1|<0.0001
71149347|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0||||0.6868|TWO_SIDED|95.0|-4.1|6.2|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.2|-4.1|0.6868
71149348|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|7.3||||0.0058|TWO_SIDED|95.0|2.2|12.5|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||12.5|2.2|0.0058
71149349|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|5.9||||0.0229|TWO_SIDED|95.0|0.8|11.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.1|0.8|0.0229
71149350|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|3.2||||0.2168|TWO_SIDED|95.0|-1.9|8.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||8.3|-1.9|0.2168
70875738|NCT01500629|141235323|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.3||||0.689||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.689
71149351|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|6.8||||0.0096|TWO_SIDED|95.0|1.7|11.9|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.9|1.7|0.0096
71149352|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|33.0|||<|0.0001|TWO_SIDED|95.0|20.0|45.9|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||45.9|20.0|<0.0001
70875739|NCT01500629|141235324|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.314||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.314
71149353|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6||||0.8009|TWO_SIDED|95.0|-11.2|14.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||14.4|-11.2|0.8009
71149354|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|17.4||||0.0086|TWO_SIDED|95.0|4.5|30.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||30.3|4.5|0.0086
71149355|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|17.2||||0.0089|TWO_SIDED|95.0|4.4|30.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||30.0|4.4|0.0089
71149356|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|5.2||||0.4224|TWO_SIDED|95.0|-7.6|18.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||18.0|-7.6|0.4224
71149357|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|22.6||||0.0006|TWO_SIDED|95.0|9.8|35.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||35.5|9.8|0.0006
71149358|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|96.1|||<|0.0001|TWO_SIDED|95.0|57.9|134.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||134.2|57.9|<0.0001
71149359|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|21.9||||0.253|TWO_SIDED|95.0|-15.8|59.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||59.7|-15.8|0.2530
71149360|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|78.6|||<|0.0001|TWO_SIDED|95.0|40.5|116.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||116.8|40.5|<0.0001
71149361|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|39.3||||0.0414|TWO_SIDED|95.0|1.6|77.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||77.1|1.6|0.0414
71149362|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|28.9||||0.1329|TWO_SIDED|95.0|-8.9|66.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||66.6|-8.9|0.1329
71149363|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|45.5||||0.0187|TWO_SIDED|95.0|7.7|83.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||83.2|7.7|0.0187
71149364|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|76.9||||0.0009|TWO_SIDED|95.0|31.9|121.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||121.9|31.9|0.0009
70875740|NCT01500629|141235325|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.8||||0.034||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.034
70875741|NCT01500629|141235326|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.845||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.845
71149365|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|45.4||||0.0456|TWO_SIDED|95.0|0.9|89.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||89.9|0.9|0.0456
71149366|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|82.8||||0.0004|TWO_SIDED|95.0|37.8|127.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||127.7|37.8|0.0004
71149367|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|39.6||||0.0812|TWO_SIDED|95.0|-5.0|84.1|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||84.1|-5.0|0.0812
71149368|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|35.5||||0.1174|TWO_SIDED|95.0|-9.0|80.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||80.0|-9.0|0.1174
71149369|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|46.1||||0.0427|TWO_SIDED|95.0|1.5|90.6|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||90.6|1.5|0.0427
71149370|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0||||0.9318|TWO_SIDED|95.0|-66.9|73.0|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||73.0|-66.9|0.9318
71149371|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|110.4||||0.002|TWO_SIDED|95.0|41.2|179.6|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||179.6|41.2|0.0020
71149372|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|81.5||||0.0226|TWO_SIDED|95.0|11.6|151.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||151.4|11.6|0.0226
71149373|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|32.0||||0.3629|TWO_SIDED|95.0|-37.3|101.2|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||101.2|-37.3|0.3629
71149374|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|35.9||||0.3077|TWO_SIDED|95.0|-33.4|105.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||105.1|-33.4|0.3077
71149375|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|39.1||||0.2662|TWO_SIDED|95.0|-30.1|108.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||108.4|-30.1|0.2662
71149376|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.4||||0.7875|TWO_SIDED|95.0|-94.7|71.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||71.9|-94.7|0.7875
71149377|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|115.0||||0.0066|TWO_SIDED|95.0|32.6|197.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||197.4|32.6|0.0066
70955987|NCT00548262|141415199|SUPERIORITY_OR_OTHER||percentage of participants with success|51.7|||||TWO_SIDED|95.0|33.5|69.9|||||95% CI based on normal approximation to the binomial.|Non-neutropenic: Success||69.9|33.5|
71149378|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|81.7||||0.054|TWO_SIDED|95.0|-1.4|164.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||164.9|-1.4|0.0540
71149379|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|21.8||||0.6014|TWO_SIDED|95.0|-60.6|104.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||104.3|-60.6|0.6014
71149380|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|36.1||||0.3885|TWO_SIDED|95.0|-46.3|118.5|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||118.5|-46.3|0.3885
71149381|NCT01746901|141791917|SUPERIORITY_OR_OTHER||LS Mean Difference|29.5||||0.4801|TWO_SIDED|95.0|-52.9|112.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||112.0|-52.9|0.4801
71149382|NCT01746901|141791918|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.5494|TWO_SIDED|95.0|-2.5|1.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.4|-2.5|0.5494
71149383|NCT01746901|141791918|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8||||0.0626|TWO_SIDED|95.0|-0.1|3.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.8|-0.1|0.0626
71149384|NCT01746901|141791918|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.7216|TWO_SIDED|95.0|-1.6|2.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.3|-1.6|0.7216
71149385|NCT01746901|141791918|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9||||0.3647|TWO_SIDED|95.0|-1.0|2.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.8|-1.0|0.3647
70875742|NCT01500629|141235327|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.619||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.619
71149386|NCT01746901|141791918|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.4456|TWO_SIDED|95.0|-2.7|1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.2|-2.7|0.4456
71149387|NCT01746901|141791918|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9||||0.05|TWO_SIDED|95.0|0.0|3.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.9|0.0|0.0500
71149388|NCT01746901|141791919|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.51|||<|0.0001|TWO_SIDED|95.0|-0.69|-0.34|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.34|-0.69|<0.0001
71149389|NCT01746901|141791919|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.69|||<|0.0001|TWO_SIDED|95.0|-1.86|-1.52|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.52|-1.86|<0.0001
71149390|NCT01746901|141791919|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-0.97|-0.63|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.63|-0.97|<0.0001
71149391|NCT01746901|141791919|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.58|-1.23|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.23|-1.58|<0.0001
71149392|NCT01746901|141791919|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.74|||<|0.0001|TWO_SIDED|95.0|-0.91|-0.56|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.56|-0.91|<0.0001
71149393|NCT01746901|141791919|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.46|-1.11|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.11|-1.46|<0.0001
71149394|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.59|||<|0.0001|TWO_SIDED|95.0|-1.75|-1.42|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.42|-1.75|<0.0001
71149395|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.3309|TWO_SIDED|95.0|-0.24|0.08|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||0.08|-0.24|0.3309
71149396|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58|||<|0.0001|TWO_SIDED|95.0|-0.74|-0.42|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.42|-0.74|<0.0001
71149397|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.09|||<|0.0001|TWO_SIDED|95.0|-1.25|-0.92|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.92|-1.25|<0.0001
70875743|NCT01500629|141235328|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.803||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.803
71149398|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.42|||<|0.0001|TWO_SIDED|95.0|-0.59|-0.26|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.26|-0.59|<0.0001
71149399|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.04|||<|0.0001|TWO_SIDED|95.0|-1.21|-0.88|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.88|-1.21|<0.0001
71149400|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.03|||<|0.0001|TWO_SIDED|95.0|-4.37|-3.69|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-3.69|-4.37|<0.0001
71149401|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.2475|TWO_SIDED|95.0|-0.54|0.14|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||0.14|-0.54|0.2475
71149402|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.61|||<|0.0001|TWO_SIDED|95.0|-1.96|-1.27|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.27|-1.96|<0.0001
71149403|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.62|||<|0.0001|TWO_SIDED|95.0|-2.96|-2.27|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-2.27|-2.96|<0.0001
71149404|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.68|-1.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.00|-1.68|<0.0001
71149405|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.42|||<|0.0001|TWO_SIDED|95.0|-2.76|-2.08|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-2.08|-2.76|<0.0001
71149406|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.91|||<|0.0001|TWO_SIDED|95.0|-13.21|-10.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-10.60|-13.21|<0.0001
71149407|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.23|||<|0.0001|TWO_SIDED|95.0|-8.54|-5.93|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-5.93|-8.54|<0.0001
71149408|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.9|||<|0.0001|TWO_SIDED|95.0|-9.2|-6.59|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-6.59|-9.20|<0.0001
71149409|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.24|||<|0.0001|TWO_SIDED|95.0|-12.55|-9.94|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-9.94|-12.55|<0.0001
71149410|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.35|||<|0.0001|TWO_SIDED|95.0|-7.65|-5.05|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-5.05|-7.65|<0.0001
71149411|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.36|||<|0.0001|TWO_SIDED|95.0|-11.67|-9.05|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-9.05|-11.67|<0.0001
71149412|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.37|||<|0.0001|TWO_SIDED|95.0|-13.16|-9.58|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-9.58|-13.16|<0.0001
71149413|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.07|||<|0.0001|TWO_SIDED|95.0|-17.86|-14.28|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-14.28|-17.86|<0.0001
71149414|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.73|||<|0.0001|TWO_SIDED|95.0|-13.53|-9.93|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-9.93|-13.53|<0.0001
71149415|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.71|||<|0.0001|TWO_SIDED|95.0|-17.51|-13.91|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-13.91|-17.51|<0.0001
71149416|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.88|||<|0.0001|TWO_SIDED|95.0|-10.67|-7.09|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-7.09|-10.67|<0.0001
71149417|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.19|||<|0.0001|TWO_SIDED|95.0|-15.99|-12.39|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-12.39|-15.99|<0.0001
71149418|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.26||||0.8784|TWO_SIDED|95.0|-3.63|3.11|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.11|-3.63|0.8784
71149419|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.66|||<|0.0001|TWO_SIDED|95.0|-45.02|-38.29|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-38.29|-45.02|<0.0001
71149420|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.63|||<|0.0001|TWO_SIDED|95.0|-23.01|-16.25|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-16.25|-23.01|<0.0001
71149421|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.28|||<|0.0001|TWO_SIDED|95.0|-25.67|-18.9|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-18.90|-25.67|<0.0001
71149422|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.5|||<|0.0001|TWO_SIDED|95.0|-15.86|-9.14|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-9.14|-15.86|<0.0001
71149423|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-20.59|||<|0.0001|TWO_SIDED|95.0|-23.98|-17.21|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-17.21|-23.98|<0.0001
71149424|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|10.64|||<|0.0001|TWO_SIDED|95.0|5.75|15.54|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||15.54|5.75|<0.0001
71149425|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.74|||<|0.0001|TWO_SIDED|95.0|-62.63|-52.85|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-52.85|-62.63|<0.0001
71149426|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.18|||<|0.0001|TWO_SIDED|95.0|-27.09|-17.27|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-17.27|-27.09|<0.0001
71149427|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.91|||<|0.0001|TWO_SIDED|95.0|-29.83|-20.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-20.00|-29.83|<0.0001
71149428|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.53|||<|0.0001|TWO_SIDED|95.0|-18.41|-8.64|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-8.64|-18.41|<0.0001
71149429|NCT01746901|141791920|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.7|||<|0.0001|TWO_SIDED|95.0|-28.62|-18.78|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-18.78|-28.62|<0.0001
71149430|NCT01746901|141791921|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.73|||<|0.0001|TWO_SIDED|95.0|-11.9|-7.57|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-7.57|-11.90|<0.0001
71149431|NCT01746901|141791921|SUPERIORITY_OR_OTHER||LS Mean Difference|5.16|||<|0.0001|TWO_SIDED|95.0|2.99|7.32|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||7.32|2.99|<0.0001
71149432|NCT01746901|141791921|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.9766|TWO_SIDED|95.0|-2.13|2.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.20|-2.13|0.9766
71149433|NCT01746901|141791921|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.61|||<|0.0001|TWO_SIDED|95.0|-6.78|-2.44|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-2.44|-6.78|<0.0001
71149434|NCT01746901|141791921|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.39||||0.7242|TWO_SIDED|95.0|-2.55|1.78|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.78|-2.55|0.7242
71149435|NCT01746901|141791921|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.45|||<|0.0001|TWO_SIDED|95.0|-6.62|-2.28|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-2.28|-6.62|<0.0001
70875744|NCT01500629|141235329|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.3||||0.175||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.175
71149436|NCT01746901|141791922|SUPERIORITY_OR_OTHER||LS Mean Difference|19.0|||<|0.0001|TWO_SIDED|95.0|14.6|23.5|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||23.5|14.6|<0.0001
71149437|NCT01746901|141791922|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.8048|TWO_SIDED|95.0|-3.9|5.0|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||5.0|-3.9|0.8048
71149438|NCT01746901|141791922|SUPERIORITY_OR_OTHER||LS Mean Difference|8.6||||0.0002|TWO_SIDED|95.0|4.2|13.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.1|4.2|0.0002
71149439|NCT01746901|141791922|SUPERIORITY_OR_OTHER||LS Mean Difference|11.0|||<|0.0001|TWO_SIDED|95.0|6.5|15.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||15.4|6.5|<0.0001
71149440|NCT01746901|141791922|SUPERIORITY_OR_OTHER||LS Mean Difference|7.1||||0.0019|TWO_SIDED|95.0|2.7|11.6|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.6|2.7|0.0019
71149441|NCT01746901|141791922|SUPERIORITY_OR_OTHER||LS Mean Difference|7.6||||0.001|TWO_SIDED|95.0|3.2|12.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||12.1|3.2|0.0010
70875745|NCT01500629|141235330|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.5||||0.206|||||||Wilcoxon (Mann-Whitney)|The rank sum test was based on period difference for comparison between sequence.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.206
71149442|NCT01746901|141791922|SUPERIORITY_OR_OTHER||LS Mean Difference|127.4|||<|0.0001|TWO_SIDED|95.0|93.6|161.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||161.2|93.6|<0.0001
71149443|NCT01746901|141791922|SUPERIORITY_OR_OTHER||LS Mean Difference|4.7||||0.7837|TWO_SIDED|95.0|-29.1|38.5|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||38.5|-29.1|0.7837
71149444|NCT01746901|141791922|SUPERIORITY_OR_OTHER||LS Mean Difference|65.8||||0.0002|TWO_SIDED|95.0|32.0|99.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||99.6|32.0|0.0002
71149445|NCT01746901|141791922|SUPERIORITY_OR_OTHER||LS Mean Difference|66.3||||0.0002|TWO_SIDED|95.0|32.5|100.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||100.1|32.5|0.0002
71149446|NCT01746901|141791922|SUPERIORITY_OR_OTHER||LS Mean Difference|60.3||||0.0006|TWO_SIDED|95.0|26.5|94.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||94.1|26.5|0.0006
71149447|NCT01746901|141791922|SUPERIORITY_OR_OTHER||LS Mean Difference|31.9||||0.064|TWO_SIDED|95.0|-1.9|65.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||65.7|-1.9|0.0640
71149448|NCT01746901|141791922|SUPERIORITY_OR_OTHER||LS Mean Difference|142.6|||<|0.0001|TWO_SIDED|95.0|94.5|190.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||190.7|94.5|<0.0001
71149449|NCT01746901|141791922|SUPERIORITY_OR_OTHER||LS Mean Difference|15.8||||0.5169|TWO_SIDED|95.0|-32.3|63.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||63.9|-32.3|0.5169
71149450|NCT01746901|141791922|SUPERIORITY_OR_OTHER||LS Mean Difference|81.3||||0.0011|TWO_SIDED|95.0|33.2|129.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||129.3|33.2|0.0011
71149451|NCT01746901|141791922|SUPERIORITY_OR_OTHER||LS Mean Difference|77.1||||0.0018|TWO_SIDED|95.0|29.1|125.2|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||125.2|29.1|0.0018
71149452|NCT01746901|141791922|SUPERIORITY_OR_OTHER||LS Mean Difference|63.6||||0.0098|TWO_SIDED|95.0|15.6|111.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||111.7|15.6|0.0098
71149453|NCT01746901|141791922|SUPERIORITY_OR_OTHER||LS Mean Difference|39.4||||0.1078|TWO_SIDED|95.0|-8.7|87.4|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||87.4|-8.7|0.1078
71149454|NCT01746901|141791922|SUPERIORITY_OR_OTHER||LS Mean Difference|196.0|||<|0.0001|TWO_SIDED|95.0|116.9|275.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||275.1|116.9|<0.0001
71149455|NCT01746901|141791922|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4||||0.9726|TWO_SIDED|95.0|-77.7|80.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||80.5|-77.7|0.9726
71149456|NCT01746901|141791922|SUPERIORITY_OR_OTHER||LS Mean Difference|114.1||||0.005|TWO_SIDED|95.0|35.0|193.2|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||193.2|35.0|0.0050
71149457|NCT01746901|141791922|SUPERIORITY_OR_OTHER||LS Mean Difference|83.3||||0.0392|TWO_SIDED|95.0|4.2|162.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||162.4|4.2|0.0392
71149458|NCT01746901|141791922|SUPERIORITY_OR_OTHER||LS Mean Difference|68.7||||0.0883|TWO_SIDED|95.0|-10.4|147.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||147.8|-10.4|0.0883
71149459|NCT01746901|141791922|SUPERIORITY_OR_OTHER||LS Mean Difference|64.4||||0.11|TWO_SIDED|95.0|-14.7|143.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||143.5|-14.7|0.1100
71149460|NCT01746901|141791922|SUPERIORITY_OR_OTHER||LS Mean Difference|242.9|||<|0.0001|TWO_SIDED|95.0|138.6|347.2|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||347.2|138.6|<0.0001
71149461|NCT01746901|141791922|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.0||||0.6906|TWO_SIDED|95.0|-125.3|83.2|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||83.2|-125.3|0.6906
71149462|NCT01746901|141791922|SUPERIORITY_OR_OTHER||LS Mean Difference|118.7||||0.0259|TWO_SIDED|95.0|14.5|223.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||223.0|14.5|0.0259
70955988|NCT00548262|141415200|SUPERIORITY_OR_OTHER||percentage of participants with success|68.6|||||TWO_SIDED|95.0|53.2|84.0|||||95% CI based on normal approximation to the binomial.|APACHE \<20 (EIVT): Success||84.0|53.2|
71149463|NCT01746901|141791922|SUPERIORITY_OR_OTHER||LS Mean Difference|103.2||||0.0525|TWO_SIDED|95.0|-1.1|207.5|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||207.5|-1.1|0.0525
71149464|NCT01746901|141791922|SUPERIORITY_OR_OTHER||LS Mean Difference|60.2||||0.2558|TWO_SIDED|95.0|-44.1|164.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||164.4|-44.1|0.2558
71149465|NCT01746901|141791922|SUPERIORITY_OR_OTHER||LS Mean Difference|88.6||||0.0952|TWO_SIDED|95.0|-15.7|192.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||192.9|-15.7|0.0952
71149466|NCT01746901|141791923|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8||||0.0298|TWO_SIDED|95.0|-3.3|-0.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.2|-3.3|0.0298
71149467|NCT01746901|141791923|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7||||0.0008|TWO_SIDED|95.0|1.1|4.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.3|1.1|0.0008
71149468|NCT01746901|141791923|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.645|TWO_SIDED|95.0|-2.0|1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.2|-2.0|0.6450
71149469|NCT01746901|141791923|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3||||0.0962|TWO_SIDED|95.0|-0.2|2.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.9|-0.2|0.0962
71149470|NCT01746901|141791923|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0||||0.193|TWO_SIDED|95.0|-2.6|0.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||0.5|-2.6|0.1930
71149471|NCT01746901|141791923|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.031|TWO_SIDED|95.0|0.2|3.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.3|0.2|0.0310
71149472|NCT01746901|141791924|SUPERIORITY_OR_OTHER||LS Mean Difference|41.5|||<|0.0001|TWO_SIDED|95.0|33.9|49.0|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||49.0|33.9|<0.0001
71149473|NCT01746901|141791924|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4||||0.3763|TWO_SIDED|95.0|-4.2|10.9|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||10.9|-4.2|0.3763
71149474|NCT01746901|141791924|SUPERIORITY_OR_OTHER||LS Mean Difference|18.3|||<|0.0001|TWO_SIDED|95.0|10.7|25.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||25.8|10.7|<0.0001
71149475|NCT01746901|141791924|SUPERIORITY_OR_OTHER||LS Mean Difference|26.6|||<|0.0001|TWO_SIDED|95.0|19.1|34.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||34.1|19.1|<0.0001
71149476|NCT01746901|141791924|SUPERIORITY_OR_OTHER||LS Mean Difference|20.7|||<|0.0001|TWO_SIDED|95.0|13.1|28.2|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.2|13.1|<0.0001
71149477|NCT01746901|141791924|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3|||<|0.0001|TWO_SIDED|95.0|11.8|26.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||26.8|11.8|<0.0001
71149478|NCT01746901|141791924|SUPERIORITY_OR_OTHER||LS Mean Difference|284.3|||<|0.0001|TWO_SIDED|95.0|232.9|335.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||335.8|232.9|<0.0001
71149479|NCT01746901|141791924|SUPERIORITY_OR_OTHER||LS Mean Difference|31.2||||0.2336|TWO_SIDED|95.0|-20.4|82.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||82.8|-20.4|0.2336
71149480|NCT01746901|141791924|SUPERIORITY_OR_OTHER||LS Mean Difference|167.3|||<|0.0001|TWO_SIDED|95.0|115.7|218.9|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||218.9|115.7|<0.0001
70875746|NCT01500629|141235331|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.5||||0.072||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.072
71149481|NCT01746901|141791924|SUPERIORITY_OR_OTHER||LS Mean Difference|148.3|||<|0.0001|TWO_SIDED|95.0|96.8|199.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||199.7|96.8|<0.0001
71149482|NCT01746901|141791924|SUPERIORITY_OR_OTHER||LS Mean Difference|135.6|||<|0.0001|TWO_SIDED|95.0|84.0|187.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||187.2|84.0|<0.0001
71149483|NCT01746901|141791924|SUPERIORITY_OR_OTHER||LS Mean Difference|113.6|||<|0.0001|TWO_SIDED|95.0|62.1|165.0|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||165.0|62.1|<0.0001
71149484|NCT01746901|141791924|SUPERIORITY_OR_OTHER||LS Mean Difference|278.3|||<|0.0001|TWO_SIDED|95.0|213.2|343.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||343.3|213.2|<0.0001
71149485|NCT01746901|141791924|SUPERIORITY_OR_OTHER||LS Mean Difference|71.3||||0.0322|TWO_SIDED|95.0|6.1|136.5|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||136.5|6.1|0.0322
71149486|NCT01746901|141791924|SUPERIORITY_OR_OTHER||LS Mean Difference|195.4|||<|0.0001|TWO_SIDED|95.0|130.2|260.5|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||260.5|130.2|<0.0001
71149487|NCT01746901|141791924|SUPERIORITY_OR_OTHER||LS Mean Difference|154.3|||<|0.0001|TWO_SIDED|95.0|89.2|219.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||219.3|89.2|<0.0001
71149488|NCT01746901|141791924|SUPERIORITY_OR_OTHER||LS Mean Difference|143.2|||<|0.0001|TWO_SIDED|95.0|78.0|208.4|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||208.4|78.0|<0.0001
71149489|NCT01746901|141791924|SUPERIORITY_OR_OTHER||LS Mean Difference|126.7||||0.0002|TWO_SIDED|95.0|61.7|191.8|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||191.8|61.7|0.0002
71149490|NCT01746901|141791924|SUPERIORITY_OR_OTHER||LS Mean Difference|202.4|||<|0.0001|TWO_SIDED|95.0|118.4|286.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||286.4|118.4|<0.0001
71149491|NCT01746901|141791924|SUPERIORITY_OR_OTHER||LS Mean Difference|137.6||||0.0015|TWO_SIDED|95.0|53.3|221.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||221.8|53.3|0.0015
71149492|NCT01746901|141791924|SUPERIORITY_OR_OTHER||LS Mean Difference|192.9|||<|0.0001|TWO_SIDED|95.0|108.7|277.2|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||277.2|108.7|<0.0001
71149493|NCT01746901|141791924|SUPERIORITY_OR_OTHER||LS Mean Difference|147.0||||0.0007|TWO_SIDED|95.0|63.0|231.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||231.1|63.0|0.0007
71149494|NCT01746901|141791924|SUPERIORITY_OR_OTHER||LS Mean Difference|148.1||||0.0007|TWO_SIDED|95.0|63.9|232.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||232.4|63.9|0.0007
71149495|NCT01746901|141791924|SUPERIORITY_OR_OTHER||LS Mean Difference|109.6||||0.011|TWO_SIDED|95.0|25.5|193.6|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||193.6|25.5|0.0110
71149496|NCT01746901|141791924|SUPERIORITY_OR_OTHER||LS Mean Difference|196.0|||<|0.0001|TWO_SIDED|95.0|107.4|284.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||284.6|107.4|<0.0001
71149497|NCT01746901|141791924|SUPERIORITY_OR_OTHER||LS Mean Difference|133.9||||0.0034|TWO_SIDED|95.0|45.0|222.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||222.8|45.0|0.0034
71149498|NCT01746901|141791924|SUPERIORITY_OR_OTHER||LS Mean Difference|190.9|||<|0.0001|TWO_SIDED|95.0|102.1|279.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||279.8|102.1|<0.0001
71149499|NCT01746901|141791924|SUPERIORITY_OR_OTHER||LS Mean Difference|138.9||||0.0023|TWO_SIDED|95.0|50.3|227.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||227.6|50.3|0.0023
71149500|NCT01746901|141791924|SUPERIORITY_OR_OTHER||LS Mean Difference|147.8||||0.0013|TWO_SIDED|95.0|59.0|236.7|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||236.7|59.0|0.0013
70955989|NCT00548262|141415200|SUPERIORITY_OR_OTHER||percentage of participants with success|22.2|||||TWO_SIDED|95.0|0.0|49.4|||||95% CI based on normal approximation to the binomial.|APACHE ≥20 (EIVT): Success||49.4|0.0|
71149501|NCT01746901|141791924|SUPERIORITY_OR_OTHER||LS Mean Difference|100.0||||0.0273|TWO_SIDED|95.0|11.3|188.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||188.6|11.3|0.0273
71149502|NCT01746901|141791925|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|||<|0.0001|TWO_SIDED|95.0|-5.0|-1.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.8|-5.0|<0.0001
71149503|NCT01746901|141791925|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9||||0.0004|TWO_SIDED|95.0|1.3|4.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.4|1.3|0.0004
71149504|NCT01746901|141791925|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.8478|TWO_SIDED|95.0|-1.7|1.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.4|-1.7|0.8478
71149505|NCT01746901|141791925|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.6192|TWO_SIDED|95.0|-1.9|1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.2|-1.9|0.6192
71149506|NCT01746901|141791925|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.8857|TWO_SIDED|95.0|-1.7|1.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.4|-1.7|0.8857
71149507|NCT01746901|141791925|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.5092|TWO_SIDED|95.0|-2.1|1.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.0|-2.1|0.5092
71149508|NCT02683577|141791938|SUPERIORITY_OR_OTHER||Geometric least square (LS) mean ratio|1.695|||||TWO_SIDED|90.0|0.904|3.176|||||A repeated-measures analysis of variance (ANOVA) was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of mild HI group (Test) versus healthy control group (Reference) for Cmax values for telotristat ethyl.||3.176|0.904|
71149509|NCT02683577|141791938|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|2.462|||||TWO_SIDED|90.0|1.579|3.837|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of moderate HI group (Test) versus healthy control group (Reference) for Cmax values for telotristat ethyl.||3.837|1.579|
71149510|NCT02683577|141791939|SUPERIORITY_OR_OTHER||Median difference|0.0|||=|1|TWO_SIDED|90.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||The Tmax was analysed using a non-parametric analysis (Walsh averages and appropriate quantile of the Wilcoxon signed rank test statistic). The median difference between the mild HI group (Test) versus healthy control group (Reference) and the corresponding 90% CIs were calculated by Hodges-Lehmann estimation.||0.000|0.000|=1.0000
71149511|NCT02683577|141791939|SUPERIORITY_OR_OTHER||Median difference|0.0|||=|1|TWO_SIDED|90.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||The Tmax was analysed using a non-parametric analysis (Walsh averages and appropriate quantile of the Wilcoxon signed rank test statistic). The median difference between the moderate HI group (Test) versus healthy control group (Reference) and the corresponding 90% CIs were calculated by Hodges-Lehmann estimation.||0.000|0.000|=1.0000
71149512|NCT02683577|141791940|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|2.294|||||TWO_SIDED|90.0|1.144|4.598|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of mild HI group (Test) versus healthy control group (Reference) for AUC(0-tlast) values for telotristat ethyl.||4.598|1.144|
71149513|NCT02683577|141791940|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|3.168|||||TWO_SIDED|90.0|1.715|5.852|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of moderate HI group (Test) versus healthy control group (Reference) on AUC(0-tlast) values for telotristat ethyl.||5.852|1.715|
71149514|NCT02683577|141791942|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|1.72|||||TWO_SIDED|90.0|1.11|2.65|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of mild HI group (Test) versus healthy control group (Reference) for Cmax values for LP-778902.||2.65|1.11|
71149515|NCT02683577|141791942|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|2.0|||||TWO_SIDED|90.0|1.51|2.66|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of moderate HI group (Test) versus healthy control group (Reference) on Cmax values for LP-778902.||2.66|1.51|
71149516|NCT02683577|141791943|SUPERIORITY_OR_OTHER||Median difference|0.0|||=|0.316|TWO_SIDED|90.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||The Tmax was analysed using a non-parametric analysis (Walsh averages and appropriate quantile of the Wilcoxon signed rank test statistic). The median differences between the hepatic impaired group (Test) versus the healthy control group (Reference) and the corresponding 90% CIs were calculated by Hodges-Lehmann estimation.||1.000|0.000|=0.3160
71149517|NCT02683577|141791943|SUPERIORITY_OR_OTHER||Median difference|0.0|||=|0.4671|TWO_SIDED|90.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||The Tmax was analysed using a non-parametric analysis (Walsh averages and appropriate quantile of the Wilcoxon signed rank test statistic). The median differences between the hepatic impaired group (Test) versus the healthy control group (Reference) and the corresponding 90% CIs were calculated by Hodges-Lehmann estimation.||1.000|0.000|=0.4671
71149518|NCT02683577|141791944|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|2.39|||||TWO_SIDED|90.0|1.45|3.94|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of mild HI group (Test) versus healthy control group (Reference) on AUC(0-tlast) values for LP-778902.||3.94|1.45|
71149519|NCT02683577|141791944|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|3.52|||||TWO_SIDED|90.0|2.45|5.03|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of moderate HI group (Test) versus healthy control group (Reference) on AUC(0-tlast) values for LP-778902.||5.03|2.45|
71149520|NCT02683577|141791945|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|2.26|||||TWO_SIDED|90.0|1.33|3.82|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of mild HI group (Test) versus healthy control group (Reference) on ln transformed AUC(0-inf) values for LP-778902.||3.82|1.33|
71149521|NCT02683577|141791945|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|3.32|||||TWO_SIDED|90.0|2.3|4.8|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of moderate HI group (Test) versus healthy control group (Reference) on AUC(0-inf) values for LP-778902.||4.80|2.30|
71149522|NCT05571605|141791960|OTHER|||||||0.05|||||||ANOVA|||||||0.05
71149523|NCT02158546|141791986|SUPERIORITY||Least square means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.95||0.782|TWO_SIDED|95.0|-2.1|1.6|||Mixed Models Analysis|||||1.6|-2.1|0.782
71149524|NCT02900378|141791990|OTHER||Differences of least square means|5.68|STANDARD_ERROR_OF_MEAN|4.89||0.2464|TWO_SIDED|95.0|-3.93|15.29||The comparison of treatment groups were out using an analysis of covariance (ANCOVA) model adjusting for treatment and baseline NYHA class (NYHA II vs. III/IV) and the 6MWT baseline value as covariates.|ANCOVA|||Change from BL at Week 12 (FAS)||15.29|-3.93|0.2464
71149525|NCT02900378|141791990|OTHER||Differences of least square means|8.98|STANDARD_ERROR_OF_MEAN|4.58||0.0503|TWO_SIDED|97.5|-1.31|19.27||The comparison of treatment groups were out using an analysis of covariance (ANCOVA) model adjusting for treatment and baseline NYHA class (NYHA II vs. III/IV) and the 6MWT baseline value as covariates.|ANCOVA|||Change from BL at Week 12 (FAS without AE/SAE)||19.27|-1.31|0.0503
71149526|NCT02900378|141791991|OTHER||Differences of least square means|-6.14|STANDARD_ERROR_OF_MEAN|8.61||0.4769|TWO_SIDED|97.5|-25.7|13.41||The comparison of treatment groups were carried out using an ANCOVA model adjusting for treatment, baseline NYHA class (NYHA II vs. III/IV) and the daily non-sedentary daytime activity baseline value as covariates.|ANCOVA|||Change from BL at Week 12 (FAS with MI)||13.41|-25.70|0.4769
71149527|NCT02900378|141791991|OTHER||Differences of least square means|-5.67|STANDARD_ERROR_OF_MEAN|6.01||0.3463|TWO_SIDED|95.0|-17.48|6.14||The comparison of treatment groups were carried out using an ANCOVA model adjusting for treatment, baseline NYHA class (NYHA II vs. III/IV) and the daily non-sedentary daytime activity baseline value as covariates.|ANCOVA|||Change from BL at Week 12 (FAS with LOCF)||6.14|-17.48|0.3463
70875747|NCT01500629|141235332|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.5||||0.014||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||.0140
71149528|NCT02900378|141791991|OTHER||Differences of least square means|-6.24|STANDARD_ERROR_OF_MEAN|6.69||0.3513|TWO_SIDED|95.0|-19.39|6.91||The comparison of treatment groups were carried out using an ANCOVA model adjusting for treatment, baseline NYHA class (NYHA II vs. III/IV) and the daily non-sedentary daytime activity baseline value as covariates.|ANCOVA|||Change from BL at Week 12 (FAS without MI/LOCF)||6.91|-19.39|0.3513
71149529|NCT02900378|141791992|OTHER||Odds Ratio (OR)|1.228|||||TWO_SIDED|95.0|0.882|1.708||||||FAS population||1.708|0.882|
71149530|NCT02900378|141791993|OTHER||Odds Ratio (OR)|1.251|||||TWO_SIDED|95.0|0.895|1.748||||||FAS subset without AE/SAE||1.748|0.895|
71149531|NCT02900378|141791994|OTHER||Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.634|2.464||||||FAS population||2.464|0.634|
71149532|NCT02900378|141791995|OTHER||Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.644|2.544||||||FAS subset without AE/SAE||2.544|0.644|
71149533|NCT02900378|141791996|OTHER||Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.863|1.811||||||FAS population||1.811|0.863|
71149534|NCT02900378|141791997|OTHER||Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|0.865|1.834||||||FAS subset without AE/SAE||1.834|0.865|
71149535|NCT02900378|141791998|OTHER|||||||0.1814|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4 (FAS)||||0.1814
71149536|NCT02900378|141791998|OTHER|||||||0.3315|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4 (FAS without AE/SAE)||||0.3315
71149537|NCT02900378|141791998|OTHER|||||||0.2414|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8 (FAS)||||0.2414
71149538|NCT02900378|141791998|OTHER|||||||0.1793|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8 (FAS without AE/SAE)||||0.1793
71149539|NCT02900378|141791999|OTHER||Odds Ratio (OR)|0.821|||||TWO_SIDED|95.0|0.462|1.457||||||Increased levels (\>= 10% increase) of non sedentary daytime physical activity at Week 12||1.457|0.462|
71149540|NCT02900378|141792000|OTHER|||||||0.0516|||||||Chi-squared|||Week 4||||0.0516
71149541|NCT02900378|141792000|OTHER|||||||0.9025|||||||Chi-squared|||Week 8||||0.9025
71149542|NCT02900378|141792000|OTHER|||||||0.6713|||||||Chi-squared|||Week 12||||0.6713
71149543|NCT02900378|141792001|OTHER|||||||0.0029|||||||Chi-squared|||Week 4||||0.0029
71149544|NCT02900378|141792001|OTHER|||||||0.7754|||||||Chi-squared|||Week 8||||0.7754
71149545|NCT02900378|141792001|OTHER|||||||0.2172|||||||Chi-squared|||Week 12||||0.2172
71149546|NCT02900378|141792002|OTHER|||||||0.0008|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1||||0.0008
70955990|NCT00548262|141415200|SUPERIORITY_OR_OTHER||percentage of participants with success|71.4|||||TWO_SIDED|95.0|56.5|86.4|||||95% CI based on normal approximation to the binomial.|APACHE \<20 (EOT): Success||86.4|56.5|
71149547|NCT02900378|141792002|OTHER|||||||0.0008|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.0008
71149548|NCT02900378|141792002|OTHER|||||||0.0297|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3||||0.0297
71149549|NCT02900378|141792002|OTHER|||||||0.0069|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0069
71149550|NCT02900378|141792002|OTHER|||||||0.2275|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5||||0.2275
71149551|NCT02900378|141792002|OTHER|||||||0.3486|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.3486
71149552|NCT02900378|141792002|OTHER|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7||||0.6800
71149553|NCT02900378|141792002|OTHER|||||||0.7184|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.7184
71149554|NCT02900378|141792002|OTHER|||||||0.5301|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9||||0.5301
71149555|NCT02900378|141792002|OTHER|||||||0.6019|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.6019
71149556|NCT02900378|141792002|OTHER|||||||0.8229|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11||||0.8229
71149557|NCT02900378|141792002|OTHER|||||||0.8229|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.8229
71149558|NCT02900378|141792003|OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.0001
71149559|NCT02900378|141792003|OTHER|||||||0.0123|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0123
71149560|NCT02900378|141792003|OTHER|||||||0.256|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.2560
71149561|NCT02900378|141792003|OTHER|||||||0.5865|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.5865
71149562|NCT02900378|141792003|OTHER|||||||0.5463|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.5463
71149563|NCT02900378|141792003|OTHER|||||||0.3212|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.3212
71149564|NCT02900378|141792004|OTHER|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1||||0.0004
71149565|NCT02900378|141792004|OTHER|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.0009
71149566|NCT02900378|141792004|OTHER|||||||0.0094|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3||||0.0094
71149567|NCT02900378|141792004|OTHER|||||||0.0301|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0301
71149568|NCT02900378|141792004|OTHER|||||||0.1557|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5||||0.1557
71149569|NCT02900378|141792004|OTHER|||||||0.6461|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.6461
71149570|NCT02900378|141792004|OTHER|||||||0.9759|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7||||0.9759
71149571|NCT02900378|141792004|OTHER|||||||0.3941|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.3941
71149572|NCT02900378|141792004|OTHER|||||||0.7209|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9||||0.7209
71149573|NCT02900378|141792004|OTHER|||||||0.4444|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.4444
71149574|NCT02900378|141792004|OTHER|||||||0.7247|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11||||0.7247
71149575|NCT02900378|141792004|OTHER|||||||0.2933|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.2933
71149576|NCT02900378|141792005|OTHER|||||||0.0854|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1||||0.0854
71149577|NCT02900378|141792005|OTHER|||||||0.0528|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.0528
71149578|NCT02900378|141792005|OTHER|||||||0.4137|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3||||0.4137
71149579|NCT02900378|141792005|OTHER|||||||0.0082|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0082
71149580|NCT02900378|141792005|OTHER|||||||0.7908|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5||||0.7908
71149581|NCT02900378|141792005|OTHER|||||||0.6499|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.6499
71149582|NCT02900378|141792005|OTHER|||||||0.5547|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7||||0.5547
71149583|NCT02900378|141792005|OTHER|||||||0.6961|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.6961
71149584|NCT02900378|141792005|OTHER|||||||0.5946|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9||||0.5946
71149585|NCT02900378|141792005|OTHER|||||||0.8957|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.8957
71149586|NCT02900378|141792005|OTHER|||||||0.8468|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11||||0.8468
71149587|NCT02900378|141792005|OTHER|||||||0.1711|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.1711
71149588|NCT02900378|141792006|OTHER|||||||0.0065|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1||||0.0065
71149589|NCT02900378|141792006|OTHER|||||||0.0316|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.0316
71149590|NCT02900378|141792006|OTHER|||||||0.1342|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3||||0.1342
71149591|NCT02900378|141792006|OTHER|||||||0.0252|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0252
70955991|NCT00548262|141415200|SUPERIORITY_OR_OTHER||percentage of participants with success|11.1|||||TWO_SIDED|95.0|0.0|31.6|||||95% CI based on normal approximation to the binomial.|APACHE ≥20 (EOT): Success||31.6|0.0|
70955992|NCT00548262|141415200|SUPERIORITY_OR_OTHER||percentage of participants with success|57.1|||||TWO_SIDED|95.0|40.7|73.5|||||95% CI based on normal approximation to the binomial.|APACHE \<20 (Week 2 F/U): Success||73.5|40.7|
71149592|NCT02900378|141792006|OTHER|||||||0.9024|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5||||0.9024
71149593|NCT02900378|141792006|OTHER|||||||0.9052|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.9052
71149594|NCT02900378|141792006|OTHER|||||||0.287|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7||||0.2870
71149595|NCT02900378|141792006|OTHER|||||||0.3174|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.3174
71149596|NCT02900378|141792006|OTHER|||||||0.502|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9||||0.5020
71149597|NCT02900378|141792006|OTHER|||||||0.4037|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.4037
71149598|NCT02900378|141792006|OTHER|||||||0.4823|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11||||0.4823
71149599|NCT02900378|141792006|OTHER|||||||0.109|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.1090
71149600|NCT02900378|141792007|OTHER|||||||0.0061|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1||||0.0061
71149601|NCT02900378|141792007|OTHER|||||||0.0143|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.0143
71149602|NCT02900378|141792007|OTHER|||||||0.0708|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3||||0.0708
71149603|NCT02900378|141792007|OTHER|||||||0.075|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0750
71149604|NCT02900378|141792007|OTHER|||||||0.8017|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5||||0.8017
71149605|NCT02900378|141792007|OTHER|||||||0.7956|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.7956
71149606|NCT02900378|141792007|OTHER|||||||0.3499|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7||||0.3499
71149607|NCT02900378|141792007|OTHER|||||||0.1192|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.1192
71149608|NCT02900378|141792007|OTHER|||||||0.5237|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9||||0.5237
71149609|NCT02900378|141792007|OTHER|||||||0.3902|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.3902
71149610|NCT02900378|141792007|OTHER|||||||0.4228|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11||||0.4228
71149611|NCT02900378|141792007|OTHER|||||||0.1571|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.1571
71149612|NCT02900378|141792008|OTHER|||||||0.3231|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1||||0.3231
71149613|NCT02900378|141792008|OTHER|||||||0.3519|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.3519
71149614|NCT02900378|141792008|OTHER|||||||0.8335|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3||||0.8335
71149615|NCT02900378|141792008|OTHER|||||||0.0465|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0465
71149616|NCT02900378|141792008|OTHER|||||||0.5016|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5||||0.5016
71149617|NCT02900378|141792008|OTHER|||||||0.5941|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.5941
71149618|NCT02900378|141792008|OTHER|||||||0.2019|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7||||0.2019
71149619|NCT02900378|141792008|OTHER|||||||0.4125|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.4125
71149620|NCT02900378|141792008|OTHER|||||||0.5702|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9||||0.5702
71149621|NCT02900378|141792008|OTHER|||||||0.4752|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.4752
71149622|NCT02900378|141792008|OTHER|||||||0.5343|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11||||0.5343
71149623|NCT02900378|141792008|OTHER|||||||0.0985|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.0985
71149624|NCT02900378|141792009|OTHER|||||||0.4525|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.4525
71149625|NCT02900378|141792009|OTHER|||||||0.0445|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0445
71149626|NCT02900378|141792009|OTHER|||||||0.1158|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.1158
71149627|NCT02900378|141792009|OTHER|||||||0.3901|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.3901
71149628|NCT02900378|141792009|OTHER|||||||0.7725|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.7725
71149629|NCT03060096|141792092|SUPERIORITY|||||||0.29|||||||Fisher Exact|||||||0.29
71149630|NCT03060096|141792093|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
71149631|NCT03060096|141792094|OTHER||Rate|0.764|||||ONE_SIDED|95.0|0.6783||||||||||0.6783|
71149632|NCT00346697|141792127|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
71149633|NCT00346697|141792128|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||.80
71149634|NCT00346697|141792129|SUPERIORITY_OR_OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
71149635|NCT00346697|141792130|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
71149636|NCT00346697|141792131|SUPERIORITY_OR_OTHER|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
71149637|NCT00346697|141792132|SUPERIORITY_OR_OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.70
71149638|NCT00346697|141792133|SUPERIORITY_OR_OTHER|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.20
71149639|NCT00346697|141792134|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||||||0.006
71149640|NCT00346697|141792135|SUPERIORITY_OR_OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
71149641|NCT00346697|141792136|SUPERIORITY_OR_OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
71149642|NCT00346697|141792137|SUPERIORITY_OR_OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
71149643|NCT00346697|141792138|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
71149644|NCT00346697|141792139|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
71149645|NCT00346697|141792140|SUPERIORITY_OR_OTHER|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
70955993|NCT00548262|141415200|SUPERIORITY_OR_OTHER||percentage of participants with success|11.1|||||TWO_SIDED|95.0|0.0|31.6|||||95% CI based on normal approximation to the binomial.|APACHE ≥20 (Week 2 F/U): Success||31.6|0.0|
71149646|NCT00346697|141792141|SUPERIORITY_OR_OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.30
71149647|NCT01055197|141792182|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.44||||0.2103|TWO_SIDED|95.0|0.82|2.53|||Log Rank|||The null hypothesis (H0) was that PCI + RT is not effective versus the alternative hypothesis (H1) that PCI + RT is effective. Assumptions were that PCI alone would have hazard rate λc of 1.204 and PCI + RT a hazard rate λc of 0.799 (hazard ratio λt/λc = 0.663). At each planned analysis, the p-value from the log-rank test statistic assessing overall survival was compared to the nominal significance level. The final targeted accrual was 154.||2.53|0.82|0.2103
71149648|NCT01055197|141792183|SUPERIORITY|||||||0.24|||||||Fisher Exact|2-sided significance level of 0.05||||||0.24
71149649|NCT01055197|141792185|SUPERIORITY|||||||0.0102|||||||Log Rank|2-sided significance level of 0.05||||||0.0102
71149650|NCT03739203|141792187|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.88||0.6798|TWO_SIDED|95.0|-2.1|1.37||p-value estimated by Mixed-effects Model for Repeated Measure from test of no difference between cariprazine dose group and placebo at Week 6.|MMRM|MMRM=Fixed effects:treatment group(TG),ADT failure category,visit,TG-by-visit;Covariates:Baseline(BL)value\& BL by-visit interaction.||||1.37|-2.10|0.6798
71149651|NCT03739203|141792187|SUPERIORITY||Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.89||0.1245|TWO_SIDED|95.0|-3.11|0.38||p-value estimated by Mixed-effects Model for Repeated Measure from test of no difference between cariprazine dose group and placebo at Week 6.|MMRM|MMRM=Fixed effects:treatment group(TG), ADT failure category,visit,TG-by-visit;Covariates:Baseline(BL)value\& BL by-visit interaction.||||0.38|-3.11|0.1245
71149652|NCT03739203|141792188|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.5152|TWO_SIDED|95.0|-0.29|0.15||p-value estimated by Mixed-effects Model for Repeated Measure from test of no difference between cariprazine dose group and placebo at Week 6.|MMRM|MMRM=Fixed effects:treatment group(TG),ADT failure category,visit,TG-by-visit;Covariates:Baseline(BL)value\& BL by-visit interaction.||||0.15|-0.29|0.5152
71149653|NCT03739203|141792188|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0573|TWO_SIDED|95.0|-0.43|0.01||p-value estimated by Mixed-effects Model for Repeated Measure from test of no difference between cariprazine dose group and placebo at Week 6.|MMRM|MMRM=Fixed effects:treatment group(TG), ADT failure category,visit,TG-by-visit;Covariates:Baseline(BL)value\& BL by-visit interaction.||||0.01|-0.43|0.0573
71149654|NCT01782378|141792199|SUPERIORITY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.33|<|0.01|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.01
71149655|NCT01782378|141792200|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.88||0.88|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||0.88
71149656|NCT01782378|141792201|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.59||0.81|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||0.81
71149657|NCT01782378|141792202|SUPERIORITY||Mean Difference (Final Values)|3.52|STANDARD_ERROR_OF_MEAN|2.88||0.23|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||0.23
71149658|NCT01782378|141792203|SUPERIORITY||Mean Difference (Final Values)|11.39|STANDARD_ERROR_OF_MEAN|7.08|<|0.12|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.12
71149659|NCT01782378|141792204|SUPERIORITY||Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|2.93|<|0.52|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.52
71149660|NCT01782378|141792205|SUPERIORITY||Mean Difference (Final Values)|3.92|STANDARD_ERROR_OF_MEAN|3.51|<|0.27|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.27
71149661|NCT01782378|141792206|SUPERIORITY||Mean Difference (Final Values)|-2.06|STANDARD_ERROR_OF_MEAN|2.26|<|0.37|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.37
71149662|NCT01782378|141792207|SUPERIORITY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.78|<|0.36|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.36
71149663|NCT01782378|141792208|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.68|<|0.46|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.46
71149664|NCT01782378|141792209|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.83|<|0.84|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.84
71149665|NCT01782378|141792210|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.75|<|0.93|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.93
71149666|NCT01782378|141792211|SUPERIORITY||Mean Difference (Final Values)|0.56|STANDARD_ERROR_OF_MEAN|3.02|<|0.85|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.85
71149667|NCT01782378|141792212|SUPERIORITY|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.|Mean Difference (Final Values)|-14.43|STANDARD_ERROR_OF_MEAN|12.54|<|0.26|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results that were considered credible.||||||<0.26
71149668|NCT01782378|141792213|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|1.7|<|0.45|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.45
70875748|NCT01500629|141235333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.907|TWO_SIDED|95.0|-0.24|0.22|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.22|-0.24|0.907
71149669|NCT01782378|141792214|SUPERIORITY||Mean Difference (Final Values)|0.87|STANDARD_ERROR_OF_MEAN|1.18|<|0.46|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.46
71149670|NCT01782378|141792215|SUPERIORITY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|1.44|<|0.64|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.64
71149671|NCT01782378|141792216|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|1.63|<|0.82|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.82
71149672|NCT01782378|141792217|SUPERIORITY||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|2.53|<|0.43|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.43
71149673|NCT01782378|141792218|SUPERIORITY||Mean Difference (Final Values)|0.91|STANDARD_ERROR_OF_MEAN|0.62|<|0.15|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.15
71149674|NCT01782378|141792219|SUPERIORITY||Mean Difference (Final Values)|3.36|STANDARD_ERROR_OF_MEAN|1.86||0.08|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||.08
71149675|NCT01782378|141792220|SUPERIORITY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.83|<|0.7|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.7
71149676|NCT01782378|141792221|SUPERIORITY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.5|<|0.48|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.48
71149677|NCT01782378|141792222|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.16|<|0.02|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.02
71149678|NCT01782378|141792223|SUPERIORITY||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.19|<|0.36|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.36
71149679|NCT01782378|141792224|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.88|<|0.82|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.82
71149680|NCT01782378|141792225|SUPERIORITY||Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|0.84|<|0.2|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.2
71149681|NCT01782378|141792226|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.86|<|0.71|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.71
71149682|NCT01782378|141792227|SUPERIORITY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.73|<|0.85|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.85
71149683|NCT01782378|141792228|SUPERIORITY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.94|<|0.44|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.44
71149684|NCT04266717|141792232|SUPERIORITY|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
71149685|NCT02420821|141792243|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0205|TWO_SIDED|95.0|0.57|0.95|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||0.95|0.57|0.0205
71149686|NCT02420821|141792245|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.2675|TWO_SIDED|95.0|0.76|1.08|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||1.08|0.76|0.2675
71149687|NCT02420821|141792247|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.263|TWO_SIDED|95.0|0.64|1.13|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||1.13|0.64|0.263
71149688|NCT02420821|141792249|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1218|TWO_SIDED|95.0|0.74|1.04|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||1.04|0.74|0.1218
71149689|NCT02420821|141792251|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.6138|TWO_SIDED|95.0|0.72|1.21|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||1.21|0.72|0.6138
71149690|NCT02420821|141792252|SUPERIORITY||Difference in Response Rates|3.3||||0.2733|TWO_SIDED|95.0|-3.09|9.7|||Cochran-Mantel-Haenszel||95% CI for difference in response rates was constructed using Wald method.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||9.70|-3.09|0.2733
71149691|NCT02420821|141792254|SUPERIORITY||Difference in Response Rates|1.96||||0.5121|TWO_SIDED|95.0|-4.32|8.24|||Cochran-Mantel-Haenszel||95% CI for difference in response rates was constructed using Wald method.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||8.24|-4.32|0.5121
71149692|NCT02420821|141792257|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0606|TWO_SIDED|95.0|0.71|1.01|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||1.01|0.71|0.0606
71149693|NCT02420821|141792258|SUPERIORITY||Difference in Response Rates|5.09||||0.1011|TWO_SIDED|95.0|-1.4|11.58|||Cochran-Mantel-Haenszel||95% CI for difference in response rates was constructed using Wald method.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||11.58|-1.40|0.1011
71149694|NCT02420821|141792261|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0254|TWO_SIDED|95.0|0.7|0.98|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||0.98|0.70|0.0254
71149695|NCT02420821|141792263|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.002|TWO_SIDED|95.0|0.34|0.79|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||0.79|0.34|0.0020
71149696|NCT02420821|141792265|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0497|TWO_SIDED|95.0|0.43|1.0|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||1.00|0.43|0.0497
71149697|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|-0.74|||<|0.0001|TWO_SIDED|95.0|-1.06|-0.43|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 1 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.43|-1.06|<0.0001
71149698|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|-0.2||||0.2085|TWO_SIDED|95.0|-0.51|0.11|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 2 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.11|-0.51|0.2085
71149699|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.33|-0.71|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 2 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.71|-1.33|<0.0001
71149700|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|-0.51||||0.0013|TWO_SIDED|95.0|-0.82|-0.2|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 3 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.20|-0.82|0.0013
71149701|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.34|-0.7|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 3 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.70|-1.34|<0.0001
71149702|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|-0.43||||0.0098|TWO_SIDED|95.0|-0.76|-0.1|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 4 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.10|-0.76|0.0098
71149703|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.32|-0.65|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 4 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.65|-1.32|<0.0001
71149704|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|-0.46||||0.008|TWO_SIDED|95.0|-0.8|-0.12|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 5 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.12|-0.80|0.0080
71149705|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|-0.78|||<|0.0001|TWO_SIDED|95.0|-1.13|-0.44|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 5 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.44|-1.13|<0.0001
71149706|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|-0.21||||0.2512|TWO_SIDED|95.0|-0.56|0.15|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 6 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.15|-0.56|0.2512
71149707|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|-0.65||||0.0005|TWO_SIDED|95.0|-1.01|-0.28|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 6 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.28|-1.01|0.0005
71149708|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|-0.43||||0.0247|TWO_SIDED|95.0|-0.8|-0.05|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 7 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.05|-0.80|0.0247
71149709|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|-0.77|||<|0.0001|TWO_SIDED|95.0|-1.15|-0.39|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 7 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.39|-1.15|<0.0001
71149710|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|-0.29||||0.1411|TWO_SIDED|95.0|-0.68|0.1|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 8 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.10|-0.68|0.1411
71149711|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|-0.65||||0.0014|TWO_SIDED|95.0|-1.05|-0.25|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 8 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.25|-1.05|0.0014
71149712|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|-0.37||||0.0728|TWO_SIDED|95.0|-0.78|0.03|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 9 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.03|-0.78|0.0728
71149713|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.32|-0.49|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 9 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.49|-1.32|<0.0001
71149714|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|-0.62||||0.0041|TWO_SIDED|95.0|-1.05|-0.2|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 10 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.20|-1.05|0.0041
71149715|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.46|-0.55|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 10 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.55|-1.46|<0.0001
71149716|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|-0.5||||0.0353|TWO_SIDED|95.0|-0.96|-0.03|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 11 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.03|-0.96|0.0353
71149717|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|-0.85||||0.0011|TWO_SIDED|95.0|-1.35|-0.34|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 11 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.34|-1.35|0.0011
71149718|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|-0.5||||0.0582|TWO_SIDED|95.0|-1.01|0.02|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 12 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.02|-1.01|0.0582
71149719|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|-0.76||||0.0089|TWO_SIDED|95.0|-1.32|-0.19|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 12 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.19|-1.32|0.0089
71149720|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|0.02||||0.9575|TWO_SIDED|95.0|-0.57|0.61|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 13 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.61|-0.57|0.9575
71149721|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|-0.36||||0.2745|TWO_SIDED|95.0|-1.01|0.29|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 13 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.29|-1.01|0.2745
71149722|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|-0.13||||0.7088|TWO_SIDED|95.0|-0.81|0.55|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 14 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.55|-0.81|0.7088
71149723|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|-0.39||||0.3077|TWO_SIDED|95.0|-1.13|0.36|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 14 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.36|-1.13|0.3077
71149724|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|-0.15||||0.7112|TWO_SIDED|95.0|-0.93|0.63|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 15 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.63|-0.93|0.7112
71149725|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|-0.79||||0.0837|TWO_SIDED|95.0|-1.69|0.11|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 15 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.11|-1.69|0.0837
70875749|NCT01500629|141235334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.666|TWO_SIDED|95.0|-0.28|0.18|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.18|-0.28|0.666
70955994|NCT02729831|141415375|SUPERIORITY||Mean Difference (Net)|9.0|||<|0.001|TWO_SIDED|95.0|6.0|12.0|||Regression, Linear|||The comparison groups were: Interactive decision versus Video decision aid.||12|6|<0.001
71149726|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|0.08||||0.8655|TWO_SIDED|95.0|-0.88|1.04|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 16 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.04|-0.88|0.8655
71149727|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|0.02||||0.9725|TWO_SIDED|95.0|-1.07|1.11|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 16 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.11|-1.07|0.9725
71149728|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|0.38||||0.5285|TWO_SIDED|95.0|-0.8|1.55|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 17 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.55|-0.80|0.5285
71149729|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|0.03||||0.9663|TWO_SIDED|95.0|-1.34|1.4|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 17 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.40|-1.34|0.9663
71149730|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|0.01||||0.9914|TWO_SIDED|95.0|-1.61|1.63|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 18 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.63|-1.61|0.9914
71149731|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|0.22||||0.8345|TWO_SIDED|95.0|-1.85|2.3|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 18 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||2.30|-1.85|0.8345
71149732|NCT02420821|141792266|SUPERIORITY||LS Mean Difference|0.5||||0.7725|TWO_SIDED|95.0|-2.9|3.91|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 19 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||3.91|-2.90|0.7725
71149733|NCT02420821|141792267|SUPERIORITY||LS Mean Difference|-0.49||||0.001|TWO_SIDED|95.0|-0.77|-0.2|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Pain: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.20|-0.77|0.0010
71149734|NCT02420821|141792267|SUPERIORITY||LS Mean Difference|-0.63|||<|0.0001|TWO_SIDED|95.0|-0.91|-0.34|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Fatigue: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.34|-0.91|<0.0001
71149735|NCT02420821|141792267|SUPERIORITY||LS Mean Difference|-0.91|||<|0.0001|TWO_SIDED|95.0|-1.13|-0.69|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Nausea: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.69|-1.13|<0.0001
71149736|NCT02420821|141792267|SUPERIORITY||LS Mean Difference|-0.52||||0.0002|TWO_SIDED|95.0|-0.79|-0.25|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Disturbed sleep: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.25|-0.79|0.0002
71149737|NCT02420821|141792267|SUPERIORITY||LS Mean Difference|-0.56|||<|0.0001|TWO_SIDED|95.0|-0.84|-0.29|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Feelings of being distressed: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.29|-0.84|<0.0001
71149738|NCT02420821|141792267|SUPERIORITY||LS Mean Difference|-0.56|||<|0.0001|TWO_SIDED|95.0|-0.81|-0.32|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Shortness of breath: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.32|-0.81|<0.0001
71149739|NCT02420821|141792267|SUPERIORITY||LS Mean Difference|-0.33||||0.0036|TWO_SIDED|95.0|-0.56|-0.11|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Remembering things: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.11|-0.56|0.0036
71149740|NCT02420821|141792267|SUPERIORITY||LS Mean Difference|-1.19|||<|0.0001|TWO_SIDED|95.0|-1.46|-0.91|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Lack of appetite: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.91|-1.46|<0.0001
71149741|NCT02420821|141792267|SUPERIORITY||LS Mean Difference|-0.54||||0.0001|TWO_SIDED|95.0|-0.81|-0.27|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Drowsy: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.27|-0.81|0.0001
71149742|NCT02420821|141792267|SUPERIORITY||LS Mean Difference|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.28|-0.71|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Dry mouth: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.71|-1.28|<0.0001
71149743|NCT02420821|141792267|SUPERIORITY||LS Mean Difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.87|-0.33|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Feeling sad: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.33|-0.87|<0.0001
71149744|NCT02420821|141792267|SUPERIORITY||LS Mean Difference|-0.58|||<|0.0001|TWO_SIDED|95.0|-0.75|-0.41|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Vomiting: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.41|-0.75|<0.0001
71149745|NCT02420821|141792267|SUPERIORITY||LS Mean Difference|-0.34||||0.0051|TWO_SIDED|95.0|-0.58|-0.1|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Numbness or tingling: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.10|-0.58|0.0051
71149746|NCT02420821|141792267|SUPERIORITY||LS Mean Difference|-1.08|||<|0.0001|TWO_SIDED|95.0|-1.33|-0.83|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Rash/Skin Changes: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.83|-1.33|<0.0001
71149747|NCT02420821|141792267|SUPERIORITY||LS Mean Difference|-0.05||||0.6541|TWO_SIDED|95.0|-0.26|0.16|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Headache: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||0.16|-0.26|0.6541
71149748|NCT02420821|141792267|SUPERIORITY||LS Mean Difference|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.28|-0.76|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Mouth/Throat Sores: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.76|-1.28|<0.0001
71149749|NCT02420821|141792267|SUPERIORITY||LS Mean Difference|-1.07|||<|0.0001|TWO_SIDED|95.0|-1.27|-0.88|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Diarrhea: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.88|-1.27|<0.0001
71149750|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.73|||<|0.0001|TWO_SIDED|95.0|0.58|0.87|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 1 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.87|0.58|<0.0001
71149751|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.42|||<|0.0001|TWO_SIDED|95.0|0.28|0.57|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 2 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.57|0.28|<0.0001
71149752|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.7|||<|0.0001|TWO_SIDED|95.0|0.55|0.84|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 2 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.84|0.55|<0.0001
71149753|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.58|||<|0.0001|TWO_SIDED|95.0|0.44|0.73|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 3 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.73|0.44|<0.0001
71149754|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.77|||<|0.0001|TWO_SIDED|95.0|0.62|0.92|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 3 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.92|0.62|<0.0001
71149755|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.62|||<|0.0001|TWO_SIDED|95.0|0.46|0.78|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 4 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.78|0.46|<0.0001
71149756|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.82|||<|0.0001|TWO_SIDED|95.0|0.66|0.97|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 4 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.97|0.66|<0.0001
71149757|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.65|||<|0.0001|TWO_SIDED|95.0|0.49|0.81|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 5 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.81|0.49|<0.0001
71149758|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.83|||<|0.0001|TWO_SIDED|95.0|0.66|0.99|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 5 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.99|0.66|<0.0001
71149759|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.63|||<|0.0001|TWO_SIDED|95.0|0.46|0.8|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 6 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.80|0.46|<0.0001
71149760|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.72|||<|0.0001|TWO_SIDED|95.0|0.54|0.89|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 6 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.89|0.54|<0.0001
71149761|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.47|||<|0.0001|TWO_SIDED|95.0|0.3|0.65|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 7 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.65|0.30|<0.0001
71149762|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.68|||<|0.0001|TWO_SIDED|95.0|0.49|0.86|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 7 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.86|0.49|<0.0001
71149763|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.47|||<|0.0001|TWO_SIDED|95.0|0.29|0.66|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 8 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.66|0.29|<0.0001
71149764|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.6|||<|0.0001|TWO_SIDED|95.0|0.41|0.79|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 8 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.79|0.41|<0.0001
71149765|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.49|||<|0.0001|TWO_SIDED|95.0|0.29|0.68|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 9 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.68|0.29|<0.0001
71149766|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.71|||<|0.0001|TWO_SIDED|95.0|0.52|0.91|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 9 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.91|0.52|<0.0001
71149767|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.53|||<|0.0001|TWO_SIDED|95.0|0.33|0.73|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 10 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.73|0.33|<0.0001
71149768|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.74|||<|0.0001|TWO_SIDED|95.0|0.51|0.96|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 10 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.96|0.51|<0.0001
71149769|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.64|||<|0.0001|TWO_SIDED|95.0|0.41|0.86|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 11 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.86|0.41|<0.0001
71149770|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.74|||<|0.0001|TWO_SIDED|95.0|0.49|0.99|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 11 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.99|0.49|<0.0001
71149771|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.42||||0.001|TWO_SIDED|95.0|0.17|0.68|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 12 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.68|0.17|0.0010
71149772|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.6|||<|0.0001|TWO_SIDED|95.0|0.32|0.89|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 12 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.89|0.32|<0.0001
71149773|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.52||||0.0005|TWO_SIDED|95.0|0.23|0.82|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 13 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.82|0.23|0.0005
71149774|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.56||||0.0008|TWO_SIDED|95.0|0.23|0.88|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 13 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.88|0.23|0.0008
71149775|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.33||||0.0591|TWO_SIDED|95.0|-0.01|0.67|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 14 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.67|-0.01|0.0591
71149776|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.67||||0.0005|TWO_SIDED|95.0|0.29|1.05|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 14 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.05|0.29|0.0005
71149777|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.3||||0.1378|TWO_SIDED|95.0|-0.09|0.68|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 15 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.68|-0.09|0.1378
71149778|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.43||||0.065|TWO_SIDED|95.0|-0.03|0.89|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 15 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.89|-0.03|0.0650
71149779|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.48||||0.0531|TWO_SIDED|95.0|-0.01|0.96|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 16 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.96|-0.01|0.0531
71149780|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.93||||0.0011|TWO_SIDED|95.0|0.37|1.49|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 16 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.49|0.37|0.0011
71149781|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.55||||0.0708|TWO_SIDED|95.0|-0.05|1.14|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 17 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.14|-0.05|0.0708
71149782|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.58||||0.1078|TWO_SIDED|95.0|-0.13|1.29|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 17 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.29|-0.13|0.1078
71149783|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.62||||0.1487|TWO_SIDED|95.0|-0.22|1.47|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 18 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.47|-0.22|0.1487
71149784|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.33||||0.5537|TWO_SIDED|95.0|-0.77|1.43|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 18 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.43|-0.77|0.5537
71149785|NCT02420821|141792270|SUPERIORITY||LS Mean Difference|0.52||||0.5743|TWO_SIDED|95.0|-1.29|2.33|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 19 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||2.33|-1.29|0.5743
71149786|NCT00999102|141792289|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.67|TWO_SIDED|95.0|-1.86|2.86|||t-test, 2 sided|Paired t-test was performed since each participant received both interventions in a crossover design.|Direction of Comparison: Mean Global Fatigue Score for Nebivolol 5 mg minus Mean Global Fatigue Score for Metoprolol 50 mg.|The null hypothesis is that there is no difference in the Global Fatigue Score after 4 weeks of Nebivolol 5 mg (lower dose) vs. 4 weeks of Metoprolol 50 mg (lower dose).||2.86|-1.86|0.67
71149787|NCT00999102|141792289|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.72|TWO_SIDED|95.0|-3.17|4.55|||t-test, 2 sided|Paired t-test was performed since each participant received both interventions in a crossover design.|Direction of Comparison: Mean Global Fatigue Score for Nebivolol 10 mg minus Mean Global Fatigue Score for Metoprolol 100 mg.|The null hypothesis is that there is no difference in the Global Fatigue Score after 4 weeks of Nebivolol 10 mg (higher dose) vs. 4 weeks of Metoprolol 100 mg (higher dose).||4.55|-3.17|0.72
71149788|NCT00999102|141792290|SUPERIORITY||Mean Difference (Final Values)|-7.03||||0.89|TWO_SIDED|95.0|-108.99|94.92|||t-test, 2 sided|Paired t-test was performed since each participant received both interventions in a crossover design.|Direction of Comparison: Mean Treadmill Exercise Time for Nebivolol 5 mg minus Mean Treadmill Exercise Time for Metoprolol 50 mg.|The null hypothesis is that there is no difference in Treadmill Exercise Time after 4 weeks of Nebivolol 5 mg (lower dose) vs. 4 weeks of Metoprolol 50 mg (lower dose).||94.92|-108.99|0.89
71149789|NCT00999102|141792290|SUPERIORITY||Mean Difference (Final Values)|-25.9||||0.43|TWO_SIDED|95.0|-91.55|39.75|||t-test, 2 sided|Paired t-test was performed since each participant received both interventions in a crossover design.|Direction of Comparison: Mean Treadmill Exercise Time for Nebivolol 10 mg minus Mean Treadmill Exercise Time for Metoprolol 100 mg.|The null hypothesis is that there is no difference in Treadmill Exercise Time after 4 weeks of Nebivolol 10 mg (higher dose) vs. 4 weeks of Metoprolol 100 mg (higher dose).||39.75|-91.55|0.43
71149790|NCT02839200|141792303|OTHER||||||<|0.001|||||||Multiple Comparison Procedure-Model|||"Multiple Comparison Procedure-Modeling (MCP-Mod) was used to assess a dose-response across placebo and all ACT-541468 doses. The null hypothesis of no dose-response was rejected if at least one of the six Multiple Contrasts Tests (MCTs) had a multiplicity adjusted p-value \<0.05. The analysis was performed using the R-package DoseFinding (Bornkamp B, Pinheiro J, Bretz F. Planning and analyzing dose finding experiments. 2016. Available from: cranrprojects.org/web/packages/DoseFinding.)"||||<0.001
71149791|NCT02839200|141792303|OTHER||LS mean difference|-7.0|STANDARD_ERROR_OF_MEAN|5.95||0.241|TWO_SIDED|95.0|-18.7|4.7|||ANCOVA||Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean|||4.7|-18.7|0.241
71149792|NCT02839200|141792303|OTHER||LS Mean difference|-10.8|STANDARD_ERROR_OF_MEAN|6.0||0.072|TWO_SIDED|95.0|-22.6|1.0|||ANCOVA||Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean|||1|-22.6|0.072
71149793|NCT02839200|141792303|OTHER||LS Mean difference|-16.2|STANDARD_ERROR_OF_MEAN|5.95||0.007|TWO_SIDED|95.0|-27.9|-4.5|||ANCOVA||Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean|||-4.5|-27.9|0.007
71149794|NCT02839200|141792303|OTHER||LS Mean difference|-25.6|STANDARD_ERROR_OF_MEAN|5.92|<|0.001|TWO_SIDED|95.0|-37.3|-13.9|||ANCOVA||Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean|||-13.9|-37.3|< 0.001
71149795|NCT02839200|141792303|OTHER||LS Mean difference|-8.5|STANDARD_ERROR_OF_MEAN|5.97||0.155|TWO_SIDED|95.0|-20.4|3.3|||ANCOVA||Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean|||3.3|-20.4|0.155
71149796|NCT01094119|141792315|SUPERIORITY|||||||0.0069|||||||Regression, Logistic|||||||0.0069
71149797|NCT02205736|141792319|SUPERIORITY|||||||0.8084||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 1 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.8084
71149798|NCT02205736|141792319|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 2 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
71149799|NCT02205736|141792319|SUPERIORITY|||||||0.0036||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 3 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0036
71149800|NCT02205736|141792319|SUPERIORITY|||||||0.0033||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 4 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0033
71149801|NCT02205736|141792319|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 5 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
71149802|NCT02205736|141792319|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 6 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
71149803|NCT02205736|141792319|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 7 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
71149804|NCT02205736|141792319|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 8 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
71149805|NCT02205736|141792319|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 9 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
71149806|NCT02205736|141792319|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 10 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
71149807|NCT02205736|141792319|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 11 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
71149808|NCT02205736|141792319|SUPERIORITY|||||||0.0124||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 12 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0124
71149809|NCT02205736|141792319|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 13 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
71149810|NCT02205736|141792319|SUPERIORITY|||||||0.0588||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 14 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0588
71149811|NCT02205736|141792319|SUPERIORITY|||||||0.0143||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 15 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0143
71149812|NCT02205736|141792319|SUPERIORITY|||||||0.1025||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 16 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.1025
70875750|NCT01500629|141235335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.972|TWO_SIDED|95.0|-0.29|0.28|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.28|-0.29|0.972
71149813|NCT02205736|141792319|SUPERIORITY|||||||0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 17 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0001
71149814|NCT02205736|141792319|SUPERIORITY|||||||0.1138||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 18 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.1138
71149815|NCT02205736|141792319|SUPERIORITY|||||||0.0011||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 19 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0011
71149816|NCT02205736|141792319|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 20 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
71149817|NCT02205736|141792319|SUPERIORITY|||||||0.0522||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 21 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0522
71149818|NCT02205736|141792319|SUPERIORITY|||||||0.8185||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 22 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.8185
71149819|NCT02205736|141792319|SUPERIORITY|||||||0.0005||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 24 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0005
71149820|NCT02205736|141792319|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Subjects recorded True/False answers to Q25 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The contingency table of 329 responses to Q25 displayed the following: N=260 Correct at Baseline and Correct at Post-Intervention (79.0%), N=7 Correct at Baseline and Incorrect at Post-Intervention (2.1%), N=49 Incorrect at Baseline and Correct at Post-Intervention (14.9%), N=13 Incorrect at Baseline and Incorrect at Post-Intervention (4.0%).||||<.0001
71149821|NCT02205736|141792320|SUPERIORITY|||||||0.2482||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 1 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.2482
71149822|NCT02205736|141792320|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 2 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||<.0001
71149823|NCT02205736|141792320|SUPERIORITY|||||||0.005||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 3 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0050
71149824|NCT02205736|141792320|SUPERIORITY|||||||0.0423||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 4 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0423
71149825|NCT02205736|141792320|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 5 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||<.0001
71149826|NCT02205736|141792320|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 6 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||<.0001
71149827|NCT02205736|141792320|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 7 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||<.0001
71149828|NCT02205736|141792320|SUPERIORITY|||||||0.0002||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 8 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0002
71149829|NCT02205736|141792320|SUPERIORITY|||||||0.7456||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 9 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.7456
71149830|NCT02205736|141792320|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 10 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||<.0001
71149831|NCT02205736|141792320|SUPERIORITY|||||||0.0028||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 11 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0028
71149832|NCT02205736|141792320|SUPERIORITY|||||||0.0707||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 12 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0707
71149833|NCT02205736|141792320|SUPERIORITY|||||||0.0026||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 13 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0026
71149834|NCT02205736|141792320|SUPERIORITY|||||||0.1797||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 14 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.1797
71149835|NCT02205736|141792320|SUPERIORITY|||||||0.6547||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 15 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.6547
71149836|NCT02205736|141792320|SUPERIORITY|||||||0.1797||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 16 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.1797
71149837|NCT02205736|141792320|SUPERIORITY|||||||0.285||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 17 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.2850
71149838|NCT02205736|141792320|SUPERIORITY|||||||0.0606||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 18 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0606
70875751|NCT01500629|141235336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.521|TWO_SIDED|95.0|-0.31|0.59|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.59|-0.31|0.521
71149839|NCT02205736|141792320|SUPERIORITY|||||||0.0045||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 19 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0045
71149840|NCT02205736|141792320|SUPERIORITY|||||||0.9068||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 20 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.9068
71149841|NCT02205736|141792320|SUPERIORITY|||||||0.4142||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 21 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.4142
71149842|NCT02205736|141792320|SUPERIORITY|||||||0.5637||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 22 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.5637
71149843|NCT02205736|141792320|SUPERIORITY|||||||0.0002||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 23 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0002
71149844|NCT02205736|141792320|SUPERIORITY|||||||0.0196||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 24 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0196
71149845|NCT02205736|141792320|SUPERIORITY||||||<|0.0001||||||This outcome measure for Q25 was tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5% in the analyses of 25 questions.|McNemar|||Patients gave True/False responses to Question 25 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||<.0001
71149846|NCT03326713|141792321|SUPERIORITY||Odds Ratio (OR)|6.2|||<|0.0001|TWO_SIDED|95.0|2.5|15.2|||Regression, Logistic|||Logistic Regression Model Results for Intervention Effects on CGRA Within 6 Months (TP vs TCN)||15.2|2.5|<.0001
71149847|NCT03326713|141792321|SUPERIORITY||Odds Ratio (OR)|7.4|||<|0.0001|TWO_SIDED|95.0|2.8|19.4|||Regression, Logistic|||Logistic Regression Model Results for Intervention Effects on CGRA Within 6 Months (UC vs TCN)||19.4|2.8|<.0001
71149848|NCT03326713|141792321|SUPERIORITY||Odds Ratio (OR)|1.2||||1.2|TWO_SIDED|95.0|0.4|4.0|||Regression, Logistic|||Logistic Regression Model Results for Intervention Effects on CGRA Within 6 Months (UC vs TP)||4.0|0.4|1.2
70875752|NCT01500629|141235337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.376|TWO_SIDED|95.0|-0.15|0.39|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.39|-0.15|0.376
71149849|NCT01198977|141792358|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.013||||||Baseline and 3-month follow-up for arm 1 and arm 2.|ANOVA|||||||.013
71149850|NCT01198977|141792358|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.005||||||Comparing baseline to 6-month follow-up.|ANOVA|||||||0.005
71149851|NCT01198977|141792358|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.01||||||The interaction effect between the two conditions across time. Baseline, 3-month, 6-month.|ANOVA|||||||0.010
71149852|NCT01198977|141792359|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.009||||||Comparing depression scores for the telephone counseling and education counseling groups at 6 months.|ANOVA|||||||0.009
71149853|NCT01198977|141792359|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group X Time interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.032||||||Interaction effects between the telephone counseling and education counseling groups over time (baseline, 3 months, 6 months).|ANOVA|||||||.032
71149854|NCT01198977|141792360|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.049||||||Physical Activity Interaction effect between the Telephone Counseling and Education Counseling Group over time (baseline, 3 months, 6 months).|ANOVA|||||||0.049
71149855|NCT01198977|141792360|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.014||||||Comparing physical activity scores for the telephone counseling and education counseling groups at 6 months.|ANOVA|||||||.014
71149856|NCT01285557|141792361|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9312|TWO_SIDED|95.0|0.76|1.28|||Unstratified Log-rank|||S-1+Cisplatin and 5FU+Cisplatin were compared using the unstratified log-rank test. The hazard ratio was estimated using a Cox's regression approach and survival was summarized using Kaplan Meier estimates along with 2-sided 95% confidence intervals (CI) for the estimates.||1.28|0.76|0.9312
71149857|NCT01285557|141792362|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.3039|TWO_SIDED|95.0|0.65|1.14|||Log Rank|||S-1+Cisplatin and 5FU+Cisplatin were compared using the log-rank test. The hazard ratio was estimated using a Cox's regression approach and survival was summarized using Kaplan Meier estimates along with 2-sided 95% confidence intervals (CI) for the estimates.||1.14|0.65|0.3039
71149858|NCT01285557|141792363|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.1683|TWO_SIDED|95.0|0.66|1.08|||Log Rank|||S-1+Cisplatin and 5FU+Cisplatin were compared using the log-rank test. The hazard ratio was estimated using a Cox's regression approach and survival was summarized using Kaplan Meier estimates along with 2-sided 95% confidence intervals (CI) for the estimates.||1.08|0.66|0.1683
71149859|NCT03173248|141792399|SUPERIORITY||Hazard Ratio (HR)|0.33||||0.0011|TWO_SIDED|95.0|0.16|0.69||P-value is calculated from the one-sided log-rank test stratified by the randomization stratification factors (AML status and geographic region).|Log Rank||Hazard ratio is estimated using a Cox's proportional hazards model stratified by the randomization stratification factors (AML status and geographic region) with placebo + azacitidine as the denominator.|||0.69|0.16|0.0011
71149860|NCT04701762|141792479|SUPERIORITY||Odds Ratio (OR)|0.2|||<|0.001|TWO_SIDED|99.32|0.14|0.29|||GLM cumulative logit GEE model|||||0.29|0.14|<0.001
71149861|NCT04701762|141792480|SUPERIORITY||Risk Ratio (RR)|0.06|||<|0.001|TWO_SIDED|99.32|0.03|0.14|||Wilcoxon (Mann-Whitney)|||||0.14|0.03|<0.001
71149862|NCT04701762|141792481|SUPERIORITY||Risk Ratio (RR)|0.87||||0.53|TWO_SIDED|99.32|0.48|1.58|||GLM log-binomial model (log link)|||||1.58|0.48|0.53
71149863|NCT04701762|141792482|SUPERIORITY||Mean Difference (Final Values)|2.0|||<|0.001|TWO_SIDED|95.0|0.92|3.1|||Mixed Models Analysis|||||3.1|0.92|<0.001
71149864|NCT04701762|141792483|SUPERIORITY||Mean Difference (Final Values)|0.44||||0.27|TWO_SIDED|95.0|-0.34|1.2|||Mixed Models Analysis|||||1.2|-0.34|0.27
71149865|NCT03762993|141792539|OTHER|Changes in phonation threshold pressure were analyzed using a linear mixed effect model. Fixed factors included in the statistical model included time, group, and restoration strategy (controlled phonation or vocal rest). In addition, appropriate interactions were included and participant was added as a random factor in order to control for individual variation.|||||<|0.001||||||P-value is for the effect of time. A priori significance level set at .05|Mixed Models Analysis|||||||<0.001
71149866|NCT03762993|141792540|OTHER|Changes in lung volumes were analyzed using a linear mixed effect model. Fixed factors included in the statistical model included time, group, and restoration strategy (controlled phonation or vocal rest). In addition, appropriate interactions were included and participant was added as a random factor in order to control for individual variation.|||||<|0.01||||||P-value represents effect of group. A priori threshold for significance set at .05|Mixed Models Analysis|||||||<0.01
71149867|NCT00753506|141792541|SUPERIORITY_OR_OTHER||F|1.59|||>|0.1|TWO_SIDED|95.0|||||ANOVA|||Repeated measures analaysis of variance||||>0.10
71149868|NCT02494323|141792555|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value is adjusted for the comparison of subjects who benefited, were satisfied and willing to continue using the Segmented Electrodes versus subjects who didn't benefit, wern't satisfied ans were not willing to continue using the Segmented Eletrode|t-test, 1 sided|||||||<0.01
71149869|NCT00790842|141792556|OTHER|Recommended Phase 2 dose for Group A|Dose in milligrams per day|25.0|||||TWO_SIDED||||||||Because no dose limiting toxicities were noted, the recommended phase 2 dose for patients with creatinine clearance of 30 to 60 mL/min is 25 mg/day|Recommended Phase 2 dose for Group A||||
71149870|NCT00790842|141792556|OTHER|Recommended phase 2 dose for patients in Group B|Dose in milligrams/day|25.0|||||TWO_SIDED||||||||Because no dose limiting toxicities were noted, the recommended phase 2 dose of lenalidomide is 25 mg/day for patients with creatinine clearance \< 30 mL/minute who are not on dialysis|Recommended phase 2 dose for patients in Group B||||
71149871|NCT00790842|141792556|OTHER|Recommended phase 2 dose for Group C|Lenalidomide dose in mg/day|25.0|||||TWO_SIDED||||||||Because no dose limiting toxicities were observed, the recommended phase 2 dose of lenalidomide is 25 mg/day for patients with creatinine clearance \< 30 mL/min who are receiving dialysis|Recommended phase 2 dose for Group C||||
71149872|NCT03408392|141792577|EQUIVALENCE|Bio-equivalence analysis comparing cefixime test and reference product has been presented.|Percentage ratio|105.38|||||TWO_SIDED|90.0|96.11|115.54||||||||115.54|96.11|
71149873|NCT03408392|141792578|EQUIVALENCE|Bio-equivalence analysis comparing cefixime test and reference product has been presented.|Percentage ratio|101.14|||||TWO_SIDED|90.0|93.37|109.55||||||||109.55|93.37|
71149874|NCT03408392|141792579|EQUIVALENCE|Bio-equivalence analysis comparing cefixime test and reference product has been presented.|Percentage ratio|105.14|||||TWO_SIDED|90.0|96.31|114.78||||||||114.78|96.31|
71149875|NCT00885170|141792601|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|2.67|||<|0.001|TWO_SIDED|95.0|1.17|4.17|||Constrained longitudinal data analysis||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|The primary hypothesis of the study was met if; in postmenopausal women previously treated with alendronate with low BMD, two years of treatment with odanacatib 50 mg significantly increased BMD at the femoral neck site compared to placebo (p-value \< 0.001).||4.17|1.17|<0.001
71149876|NCT00885170|141792602|SUPERIORITY_OR_OTHER||Difference in Percentages vs. Placebo|-5.5|||||TWO_SIDED|95.0|-16.9|6.0|||||Based on Miettinen \& Nurminen method.|||6.0|-16.9|
71149877|NCT00885170|141792603|SUPERIORITY_OR_OTHER||Difference in the Percentage vs. Placebo|5.7|||||TWO_SIDED|95.0|-0.4|12.6|||||Based on Miettinen \& Nurminen method.|||12.6|-0.4|
71149878|NCT00885170|141792604|SUPERIORITY_OR_OTHER||Difference in the least Squares Means|0.88||||0.166|TWO_SIDED|95.0|-0.37|2.14|||Constrained longitudinal data analysis||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||2.14|-0.37|0.166
71149879|NCT00885170|141792605|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|3.18||||0.002|TWO_SIDED|95.0|1.19|5.17|||Constrained longitudinal data analysis||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||5.17|1.19|0.002
71149880|NCT00885170|141792606|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|1.0||||0.142|TWO_SIDED|95.0|-0.34|2.35|||Constrained longitudinal data analysis||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||2.35|-0.34|0.142
71149881|NCT00885170|141792607|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|2.7|||<|0.001|TWO_SIDED|95.0|1.41|4.0|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||4.00|1.41|<0.001
71149882|NCT00885170|141792608|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|1.06||||0.023|TWO_SIDED|95.0|0.15|1.98|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||1.98|0.15|0.023
71149883|NCT00885170|141792609|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|2.57|||<|0.001|TWO_SIDED|95.0|1.26|3.89|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||3.89|1.26|<0.001
71149884|NCT00885170|141792610|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|0.8||||0.103|TWO_SIDED|95.0|-0.16|1.77|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||1.77|-0.16|0.103
71149885|NCT00885170|141792611|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|0.22||||0.763|TWO_SIDED|95.0|-1.23|1.67|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||1.67|-1.23|0.763
71149886|NCT00885170|141792612|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|0.38||||0.578|TWO_SIDED|95.0|-0.96|1.72|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||1.72|-0.96|0.578
71149887|NCT00885170|141792613|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|10.16||||0.5|TWO_SIDED|95.0|-19.39|39.72|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||39.72|-19.39|0.500
71149888|NCT00885170|141792614|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-5.82||||0.709|TWO_SIDED|95.0|-36.29|24.65|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||24.65|-36.29|0.709
71149889|NCT00885170|141792615|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-47.04|||<|0.001|TWO_SIDED|95.0|-62.4|-31.67|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||-31.67|-62.40|<0.001
71149890|NCT00885170|141792616|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-46.29|||<|0.001|TWO_SIDED|95.0|-61.43|-31.15|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||-31.15|-61.43|<0.001
71149891|NCT00885170|141792617|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|10.96||||0.186|TWO_SIDED|95.0|-5.29|27.22|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||27.22|-5.29|0.186
71149892|NCT00885170|141792618|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|12.82||||0.015|TWO_SIDED|95.0|2.54|23.1|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||23.10|2.54|0.015
71149893|NCT00885170|141792619|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|31.17||||0.011|TWO_SIDED|95.0|7.13|55.21|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||55.21|7.13|0.011
71149894|NCT00885170|141792620|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|24.01||||0.059|TWO_SIDED|95.0|-0.93|48.94|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||48.94|-0.93|0.059
71149895|NCT00885170|141792621|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|0.11||||0.846|TWO_SIDED|95.0|-0.95|1.16|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||1.16|-0.95|0.846
71149896|NCT00885170|141792622|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|1.38||||0.413|TWO_SIDED|95.0|-1.91|4.67|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||4.67|-1.91|0.413
71149897|NCT00885170|141792623|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-5.91||||0.326|TWO_SIDED|95.0|-17.66|5.85|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||5.85|-17.66|0.326
71149898|NCT00885170|141792624|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|1.47||||0.835|TWO_SIDED|95.0|-12.37|15.32|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||15.32|-12.37|0.835
71149899|NCT00885170|141792625|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-3.13||||0.376|TWO_SIDED|95.0|-10.04|3.78|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||3.78|-10.04|0.376
71149900|NCT00561925|141792626|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of nevirapine XR to nevirapine IR was established if the lower bound of the confidence interval was greater than -10%|Cochran's statistic|4.9|||<|0.0001||95.0|-0.1|10.0|||Cochran's statistic||Weighted treatment difference and corresponding variance were calculated based on Cochran's statistic.|||10.0|-0.1|<0.0001
71149901|NCT00561925|141792628|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of nevirapine XR to nevirapine IR was established if the lower bound of the confidence interval was greater than -2%|Cochran's statistic|4.84|||<|0.0001||95.0|-1.11|10.79|||Cochran's statistic||Weighted treatment difference and corresponding variance were calculated based on Cochran's statistic.|||10.79|-1.11|<0.0001
71149902|NCT00561925|141792630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.7719||95.0|-0.08|0.06|||ANCOVA|Means adjusted for baseline HIV-1 viral load stratum||||0.06|-0.08|0.7719
71149903|NCT00561925|141792631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.87||||0.0078||95.0|8.67|57.06|||ANCOVA|Means adjusted for baseline HIV-1 viral load stratum||||57.06|8.67|0.0078
71149904|NCT00561925|141792639|NON_INFERIORITY_OR_EQUIVALENCE|equivalence test with 80% -125% boundaries|adjusted gMean|79.58|STANDARD_ERROR_OF_MEAN|1.04||0.5542||90.0|74.62|84.86||p-value for ratio outside the interval 80%-125%|ANOVA||Inter-individual gCV = 49.9|adjusted geometric mean ratio NVP XR : NVP IR||84.86|74.62|0.5542
71149905|NCT05021978|141792642|OTHER|||||||0.1048||||||Change from baseline to Day 7 in TETRAS Upper Limb Score|Mixed Models Analysis|Includes timepoint as fixed effect and baseline TETRAS score as a covariate. Within subject variability modeled using unstructured covariance pattern.||Sample size is a convenience sample determined according to feasibility to provide sufficient and safety data to inform the development of future controlled studies with PRAX-944. In the open-label phase of the trial (Part A ), at least 10 participants would provide an 80% probability of observing at least 1 AE with an underlying incidence of 15% or greater and provide approximately 80% power to detect an effect size of 1.0 on the primary endpoint change from baseline in TETRAS Upper Limb score.||||0.1048
71149906|NCT05021978|141792642|OTHER|||||||0.0028||||||Change from baseline to Day 14 in TETRAS UL score|Mixed Models Analysis|||||||0.0028
71149907|NCT05021978|141792646|OTHER|||||||0.4025|||||||Mixed Models Analysis|Change from baseline to Day 7||||||0.4025
71149908|NCT05021978|141792646|OTHER|||||||0.0766||||||Change from baseline to Day 14|Mixed Models Analysis|||||||0.0766
71149909|NCT05021978|141792647|OTHER|||||||0.2501||||||Change from baseline to Day 7|Mixed Models Analysis|||||||0.2501
71149910|NCT05021978|141792647|OTHER|||||||0.1874||||||Chnage from baseline to Day 14|Mixed Models Analysis|||||||0.1874
71149911|NCT05021978|141792648|OTHER|||||||0.4722||||||Item 6 Archimedes Spiral (right) change from baseline to Day 7|Mixed Models Analysis|||||||0.4722
71149912|NCT05021978|141792648|OTHER|||||||0.6215||||||Item 6 Archimedes Spiral (left) change from baseline to Day 7|Mixed Models Analysis|||||||0.6215
71149913|NCT05021978|141792648|OTHER|||||||0.9648||||||Item 7 Handwriting change from baseline to Day 7|Mixed Models Analysis|||||||0.9648
71149914|NCT05021978|141792648|OTHER|||||||0.2855||||||Item 7 Handwriting change from baseline to Day 14|Mixed Models Analysis|||||||0.2855
71149915|NCT05021978|141792648|OTHER|||||||0.205||||||Item 6 Archimedes Spiral (right) change from baseline to Day 14|Mixed Models Analysis|||||||0.2050
71149916|NCT05021978|141792648|OTHER|||||||0.2364||||||Item 6 Archimedes Spiral (left) change from baseline to Day 14|Mixed Models Analysis|||||||0.2364
71149917|NCT05021978|141792652|OTHER|||||||0.0216|||||||Mixed Models Analysis|||||||0.0216
71149918|NCT05021978|141792653|OTHER|||||||0.1042||||||Change from baseline Day 7|Mixed Models Analysis|||||||0.1042
71149919|NCT05021978|141792653|OTHER|||||||0.0257||||||Change from baseline Day 21|Mixed Models Analysis|||||||0.0257
71149920|NCT05021978|141792654|OTHER|||||||0.2971||||||Change from baseline to Day 7|Mixed Models Analysis|||||||0.2971
71149921|NCT05021978|141792654|OTHER|||||||0.2034||||||Change from baseline Day 21|Mixed Models Analysis|||||||0.2034
71149922|NCT05021978|141792654|OTHER|||||||0.1105||||||Change from baseline to Day 42|Mixed Models Analysis|||||||0.1105
71149923|NCT05021978|141792655|OTHER|||||||0.005||||||Change from baseline to Day 7|Mixed Models Analysis|||||||0.0050
71149924|NCT05021978|141792655|OTHER|||||||0.0018||||||Change from baseline to Day 21|Mixed Models Analysis|||||||0.0018
71149925|NCT05021978|141792655|OTHER|||||||0.0061||||||Change from baseline to Day 42|Mixed Models Analysis|||||||0.0061
71149926|NCT05021978|141792656|OTHER|||||||0.9776||||||Item 6 Archimedes Spiral (right) change from baseline to Day 7|Mixed Models Analysis|||||||0.9776
71149927|NCT05021978|141792656|OTHER|||||||0.1962||||||Item 6 Archimedes Spiral (left) change from baseline to Day 7|Mixed Models Analysis|||||||0.1962
71149928|NCT05021978|141792656|OTHER|||||||0.9419||||||Item 7 Handwriting change from baseline to Day 7|Mixed Models Analysis|||||||0.9419
71149929|NCT05021978|141792656|OTHER|||||||0.0668||||||Item 6 Archimedes Spiral (right) change from baseline to Day 21|Mixed Models Analysis|||||||0.0668
71149930|NCT05021978|141792656|OTHER|||||||0.9191||||||Item 6 Archimedes Spiral (left) change from baseline to Day 21|Mixed Models Analysis|||||||0.9191
71149931|NCT05021978|141792656|OTHER|||||||0.6075||||||Item 7 Handwriting change from baseline to Day 21|Mixed Models Analysis|||||||0.6075
71149932|NCT05021978|141792656|OTHER|||||||0.246||||||Item 6 Archimedes Spiral (right) change from baseline to Day 42|Mixed Models Analysis|||||||0.2460
71149933|NCT05021978|141792656|OTHER|||||||0.6736||||||Item 6 Archimedes Spiral (left) change from baseline to Day 42|Mixed Models Analysis|||||||0.6736
71149934|NCT05021978|141792656|OTHER|||||||0.8511||||||Item 7 Handwriting change from baseline to Day 42|Mixed Models Analysis|||||||0.8511
71149935|NCT05021978|141792657|OTHER|||||||0.1505||||||Change from baseline to Day 7|Mixed Models Analysis|||||||0.1505
71149936|NCT05021978|141792657|OTHER|||||||0.0543||||||Change from baseline to Day 21|Mixed Models Analysis|||||||0.0543
71149937|NCT05021978|141792657|OTHER|||||||0.0015||||||Change from baseline to Day 42|Mixed Models Analysis|||||||0.0015
71149938|NCT05021978|141792658|OTHER|||||||0.8638||||||Change from baseline to Day 7|Mixed Models Analysis|||||||0.8638
71149939|NCT05021978|141792658|OTHER|||||||0.0605||||||Change from baseline to Day 21|Mixed Models Analysis|||||||0.0605
71149940|NCT05021978|141792658|OTHER|||||||0.0871||||||Change from baseline to Day 42|Mixed Models Analysis|||||||0.0871
71149941|NCT02177032|141792660|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen compared to the currently recommended 2-sites TRC (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at day 50 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-1.0|||||TWO_SIDED|95.0|-2.4|0.0|||Fisher Exact|||||0|-2.4|
71149942|NCT02177032|141792661|NON_INFERIORITY_OR_EQUIVALENCE|"The investigational regimen 4-sites, 1-week ID PEP will be declared as non-inferior to currently recommended 2-sites TRC ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667."|Vaccine Group Ratios|0.46|||||TWO_SIDED|95.0|0.37|0.58|||ANOVA|||||0.58|0.37|
71149943|NCT02177032|141792662|NON_INFERIORITY_OR_EQUIVALENCE|"The investigational regimen 4-sites, 1-week ID PEP will be declared as non-inferior to currently recommended 2-sites TRC ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 8)"|Vaccine Group Ratios|1.04|||||TWO_SIDED|95.0|0.84|1.29|||ANOVA|||||1.29|0.84|
71149944|NCT02177032|141792662|NON_INFERIORITY_OR_EQUIVALENCE|"The investigational regimen 4-sites, 1-week ID PEP will be declared as non-inferior to currently recommended 2-sites TRC ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 15)"|Vaccine Group Ratios|1.68|||||TWO_SIDED|95.0|1.35|2.1|||ANOVA|||||2.1|1.35|
71149945|NCT02177032|141792662|NON_INFERIORITY_OR_EQUIVALENCE|"The investigational regimen 4-sites, 1-week ID PEP will be declared as non-inferior to currently recommended 2-sites TRC ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 91)."|Vaccine Group Ratios|0.68|||||TWO_SIDED|95.0|0.54|0.85|||ANOVA|||||0.85|0.54|
71149946|NCT02177032|141792662|NON_INFERIORITY_OR_EQUIVALENCE|"The investigational regimen 4-sites, 1-week ID PEP will be declared as non-inferior to currently recommended 2-sites TRC ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 181)"|Vaccine Group Ratios|1.22|||||TWO_SIDED|95.0|0.94|1.59|||ANOVA|||||1.59|0.94|
71149947|NCT02177032|141792662|NON_INFERIORITY_OR_EQUIVALENCE|"The investigational regimen 4-sites, 1-week ID PEP will be declared as non-inferior to currently recommended 2-sites TRC ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 366)"|Vaccine Group Ratios|1.67|||||TWO_SIDED|95.0|1.27|2.19|||ANOVA|||||2.19|1.27|
71149948|NCT02177032|141792663|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen compared to the currently recommended 2-sites TRC (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 8 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|9.0|||||TWO_SIDED|95.0|3.8|13.9|||Fisher Exact|||||13.9|3.8|
71149949|NCT02177032|141792663|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen compared to the currently recommended 2-sites TRC (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 15 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|0.0|||||TWO_SIDED|95.0|-1.0|1.6|||Fisher Exact|||||1.6|-1|
71149950|NCT02177032|141792663|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen compared to the currently recommended 2-sites TRC (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 91 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-3.0|||||TWO_SIDED|95.0|-6.0|-1.4|||Fisher Exact|||||-1.4|-6|
71149951|NCT02177032|141792663|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen compared to the currently recommended 2-sites TRC (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 181 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-1.0|||||TWO_SIDED|95.0|-4.5|3.2|||Fisher Exact|||||3.2|-4.5|
71149952|NCT02177032|141792663|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen compared to the currently recommended 2-sites TRC (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 366 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|6.0|||||TWO_SIDED|95.0|1.3|11.5|||Fisher Exact|||||11.5|1.3|
71149953|NCT02177032|141792664|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 8 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-11.0|||||TWO_SIDED|95.0|-19.6|-1.0|||Fisher Exact|||||-1|-19.6|
71149954|NCT02177032|141792664|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 15 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|0.0|||||TWO_SIDED|95.0|-5.6|2.6|||Fisher Exact|||||2.6|-5.6|
71149955|NCT02177032|141792664|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 91 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-15.0|||||TWO_SIDED|95.0|-26.0|-7.1|||Fisher Exact|||||-7.1|-26|
71149956|NCT02177032|141792664|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 181 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-17.0|||||TWO_SIDED|95.0|-29.0|-7.1|||Fisher Exact|||||-7.1|-29|
71149957|NCT02177032|141792664|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 366 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-25.0|||||TWO_SIDED|95.0|-37.8|-13.2|||Fisher Exact|||||-13.2|-37.8|
70955995|NCT02729831|141415376|SUPERIORITY||Odds Ratio (OR)|1.03||||0.86|TWO_SIDED|95.0|0.74|1.44|||Regression, Logistic|General Estimating Equations accounted for clustering of patients within surgeons and controlling for baseline EQ-5D, BMI, joint and education.||We tested for interaction effects. Comparison groups were: MD Usual Care vs. MD Provider report.||1.44|0.74|0.86
70955996|NCT02729831|141415376|SUPERIORITY||Odds Ratio (OR)|1.06||||0.75|TWO_SIDED|95.0|0.76|1.47|||Regression, Logistic|General Estimating Equations accounted for clustering of patients within surgeons and controlling for baseline EQ-5D, BMI, joint and education.||We tested for interaction effects. Comparison groups are: Interactive decision versus Video decision aid||1.47|0.76|0.75
70955997|NCT02729831|141415377|SUPERIORITY||Risk Difference (RD)|18.5|||<|0.001|TWO_SIDED|95.0|12.8|24.5|||Chi-squared|Compared patients who reported using all of the DA compared to everyone else.||Comparison groups were: patients who reported using all of the DA versus everyone else.||24.5|12.8|<0.001
70955998|NCT02729831|141415378|SUPERIORITY||Mean Difference (Net)|0.04|||<|0.001|TWO_SIDED|95.0|0.016|0.065|||Regression, Linear|Generalized Estimating Equation accounting for clustering within surgeons. Model included treatment, sex, age, education, site and joint.||We included all 4 study groups, but the comparison group was: informed, patient centered decision yes vs. no.||0.065|0.016|<0.001
70955999|NCT02729831|141415379|SUPERIORITY||Odds Ratio (OR)|25.7|||<|0.001|TWO_SIDED|95.0|16.5|40.1|||Regression, Logistic|General estimating equations were used to account for clustering of patients within surgeons.||We included all 4 study groups, but the comparison group was: informed, patient centered (IPC) decision yes vs. no. We excluded those who did not provide information to calculate the IPC variable.||40.1|16.5|<0.001
70956000|NCT01747551|141415380|SUPERIORITY|||||||0.72|||||||Log Rank|||||||0.72
70956001|NCT01142115|141415384|NON_INFERIORITY_OR_EQUIVALENCE|The estimated difference VAS(Monza) minus VAS(SpeediCath)(i.e. the upper confidence limit) shall be less than 1cm to demonstrate non-inferiority.|Mean Difference (Final Values)|1.052||||0.0018|TWO_SIDED|95.0|0.412|1.692|||Mixed Models Analysis|||||1.692|0.412|0.0018
70956002|NCT01142115|141415385|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.805|||<|0.0001|TWO_SIDED|95.0|2.604|12.939|||Regression, Logistic|||||12.939|2.604|<0.0001
71149958|NCT02504151|141792723|SUPERIORITY||Mean Difference (Net)|-0.284|STANDARD_ERROR_OF_MEAN|1.01||0.08|TWO_SIDED|95.0|-2.28|1.71|||Mixed Models Analysis|Linear mixed models was used with treatment, time and time\*treatment interaction in the model.|This is the estimated difference between treatment groups (cbd - placebo).|The p value is based on the interaction of treatment and time.||1.71|-2.28|0.08
71149959|NCT02504151|141792724|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.05||0.48|TWO_SIDED|95.0|-0.12|0.07|||Mixed Models Analysis||This is the estimated difference between treatment groups (cbd - placebo).|The p value is based on the interaction of treatment and time.||0.07|-0.12|0.48
71149960|NCT02504151|141792725|SUPERIORITY||Mean Difference (Net)|-4.97|STANDARD_ERROR_OF_MEAN|2.47||0.485|TWO_SIDED|95.0|-9.87|-0.06|||Mixed Models Analysis||This is the estimated difference between treatment groups (cbd - placebo).|The p value is based on the interaction of treatment and time.||-0.06|-9.87|0.485
71149961|NCT02504151|141792726|SUPERIORITY||Mean Difference (Net)|4.13|STANDARD_ERROR_OF_MEAN|2.05||0.994|TWO_SIDED|95.0|0.07|8.19|||Mixed Models Analysis||This is the estimated difference between treatment groups (cbd - placebo).|The p value is based on the interaction of treatment and time.||8.19|0.07|0.994
71149962|NCT00538902|141792757|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.026||95.0|1.09|4.39||Each comparison was tested at the 2-sided alpha level of 0.05. Subjects with missing data were imputed to be non-responders. The overall type I error rate was preserved by a hierarchical stepwise closed testing procedure.|Cochran-Mantel-Haenszel|||A sample size of 42 subjects in the placebo group and 84 subjects in each of the adalimumab groups was needed to achieve 98% power to detect that the ACR20 response rate in the 80 mg adalimumab group was different from placebo and to achieve 84% power to detect that the 40 mg adalimumab group was different from placebo.||4.39|1.09|0.026
71149963|NCT00538902|141792757|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.68||||0.004||95.0|1.35|5.3||Each comparison was tested at the 2-sided alpha level of 0.05. Subjects with missing data were imputed to be non-responders. The overall type I error rate was preserved by a hierarchical stepwise closed testing procedure.|Cochran-Mantel-Haenszel|||A sample size of 42 subjects in the placebo group and 84 subjects in each of the adalimumab groups was needed to achieve 98% power to detect that the ACR20 response rate in the 80 mg adalimumab group was different from placebo and to achieve 84% power to detect that the 40 mg adalimumab group was different from placebo.||5.30|1.35|0.004
71149964|NCT00538902|141792758|SUPERIORITY_OR_OTHER|||||||0.009||||||The between-treatment comparison between each adalimumab group vs. placebo was performed at the 2-sided alpha = 0.05 significance level, without using a stepwise testing procedure or alpha adjustment.|Cochran-Mantel-Haenszel|Percentage ACR responders at Week 12 were compared between adalimumab and placebo groups, where missing ACR responses were imputed as non-responder.||||||0.009
71149965|NCT00538902|141792758|SUPERIORITY_OR_OTHER|||||||0.121|||||||Cochran-Mantel-Haenszel|||||||0.121
71149966|NCT00472576|141792774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.291|STANDARD_ERROR_OF_MEAN|0.693||0.001|TWO_SIDED|95.0|0.911|3.671|||Mixed Models Analysis||Mean differences reflect groups differences at end point.|A linear mixed model with restricted maximum likelihood estimation was used to examine the effects of treatment (MK-0657 and placebo) over time (treatment day) with the baseline of each phase as a covariate. A main effect for phase of study was also included. Schwarz's Bayesian criteria was used to determine the best fitting variance-covariance structure which was an autoregressive moving average model. Bonferroni adjusted simple effects tests were used to evaluate significant effects.||3.671|0.911|.001
70956003|NCT01142115|141415386|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.822||||0.616|TWO_SIDED|95.0|0.382|1.767|||Proportional odds regression model|||||1.767|0.382|0.6160
70956004|NCT01142115|141415387|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.117||||0.8014|TWO_SIDED|95.0|0.472|2.646|||Proportional odds regression model|||||2.646|0.472|0.8014
70956005|NCT01142115|141415388|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.503||||0.3085|TWO_SIDED|95.0|0.314|39.106|||Regression, Logistic|||||39.106|0.314|0.3085
70956006|NCT01142115|141415389|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.398||||0.4324|TWO_SIDED|95.0|0.606|3.225|||Proportional odds regression model|||||3.225|0.606|0.4324
70956007|NCT03208036|141415390|SUPERIORITY||||||=|0.69|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .69
70956008|NCT03208036|141415390|SUPERIORITY||||||=|0.74|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .74
71149967|NCT00472576|141792775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|2.479||0.272|TWO_SIDED|95.0|-6.981|2.901||This test is a comparison of the MK-0657 condition to the placebo condition.|Mixed Models Analysis||The primary outcome of interest is whether the groups differ at the end of the study, so the means represent values at that point in time.|A linear mixed model with restricted maximum likelihood estimation was used to examine the effects of treatment (MK-0657 and placebo) over time (treatment day) with the baseline of each phase as a covariate. A main effect for phase of study was also included. Schwarz's Bayesian criteria was used to determine the best fitting variance-covariance structure which was an autoregressive moving average model. Bonferroni adjusted simple effects tests were used to evaluate significant effects.||2.901|-6.981|.272
71149968|NCT02557139|141792780|EQUIVALENCE|If the 90% confidence interval for the comparison of fed vs. fasted is within the acceptance range 80.00% to 125.00%, then it is concluded that there is no effect of food on belumosudil tablets.|Ratio of Adjusted Geometric Means (%)|100.0|||<|0.001|TWO_SIDED|90.0|80.0|125.0|||t-test, 2 sided|||Cmax null hypothesis: Ratio of Adjusted Geometric Means = 100%|Intra-subject variability: 48.00%|125.00|80.00|< 0.001
71149969|NCT02557139|141792780|EQUIVALENCE|If the 90% confidence interval for the comparison of belumosudil tablet (test drug) vs. the belumosudil capsule (reference drug) is within the acceptance range 80.00% to 125.00%, then it is concluded that there is no effect on the use of belumosudi tablet compared to belumosudil capsule.|Ratio of Geometric Means (%)|100.0||||0.23|TWO_SIDED|90.0|80.0|125.0|||t-test, 2 sided|||Cmax null hypothesis: Ratio of Adjusted Geometric Means = 100%|Intra-subject variability: 48.00%|125.00|80.00|0.23
71149970|NCT02557139|141792781|EQUIVALENCE|If the 90% confidence interval for the comparison of fed vs. fasted is within the acceptance range 80.00% to 125.00%, then it is concluded that there is no effect of food on belumosudil tablets.|Ratio of Adjusted Geometric Means (%)|100.0|||<|0.001|TWO_SIDED|90.0|80.0|125.0|||t-test, 2 sided|||AUC(0-inf) Null Hypothesis: Ratio of Adjusted Geometric Means = 100%|Intra-subject variability: 34.25%|125.00|80.00|<0.001
71149971|NCT02557139|141792781|EQUIVALENCE|If the 90% confidence interval for the comparison of belumosudil tablet (test drug) vs. the belumosudil capsule (reference drug) is within the acceptance range 80.00% to 125.00%, then it is concluded that there is no effect on the use of belumosudi tablet compared to belumosudil capsule.|Ratio of Adjusted Geometric Means (%)|100.0||||0.16|TWO_SIDED|90.0|80.0|125.0|||t-test, 2 sided|||AUC(0-inf) Null Hypothesis: Ratio of Adjusted Geometric Means = 100%|Intra-subject variability;|125.00|80.00|0.16
71149972|NCT02557139|141792781|EQUIVALENCE|If the 90% confidence interval for the comparison of fed vs. fasted is within the acceptance range 80.00% to 125.00%, then it is concluded that there is no effect of food on belumosudil tablets.|Ratio of Adjusted Geometric Means (%)|100.0|||<|0.001|TWO_SIDED|90.0|80.0|125.0|||t-test, 2 sided|||AUC(0-last) Null Hypothesis: Ratio of Adjusted Geometric Means = 100%|Intra-subject variability = 38.16%|125.00|80.00|< 0.001
71149973|NCT02557139|141792781|EQUIVALENCE|If the 90% confidence interval for the comparison of belumosudil tablet (test drug) vs. the belumosudil capsule (reference drug) is within the acceptance range 80.00% to 125.00%, then it is concluded that there is no effect on the use of belumosudi tablet compared to belumosudil capsule.|Ratio of Adjusted Geometric Means (%)|100.0||||0.18|TWO_SIDED|90.0|80.0|125.0|||t-test, 2 sided||Intra-subject variability = 38.16%|AUC(0-last) Null Hypothesis: Ratio of Adjusted Geometric Means = 100%|Intra-subject variability = 38.16%|125.00|80.00|0.18
71149974|NCT02148874|141792807|SUPERIORITY||Odds Ratio (OR)|1.05||||0.84|TWO_SIDED|95.0|0.64|1.73|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H1N1.||1.73|0.64|0.84
71149975|NCT02148874|141792807|SUPERIORITY||Odds Ratio (OR)|1.07||||0.79|TWO_SIDED|95.0|0.65|1.75|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H3N2||1.75|0.65|0.79
70956009|NCT03208036|141415391|SUPERIORITY||||||=|0.62|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .62
70956010|NCT03208036|141415391|SUPERIORITY||||||=|0.24|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .24
70956011|NCT03208036|141415392|SUPERIORITY||||||=|0.47|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .47
70956012|NCT03208036|141415392|SUPERIORITY||||||=|0.09|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .09
70956013|NCT03208036|141415392|SUPERIORITY||||||=|0.02|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .02
70956014|NCT03208036|141415392|SUPERIORITY||||||=|0.48|||||||t-test, 2 sided|||Within group change assessed between baseline and the 5.5 month assessment.||||= .48
70956015|NCT03208036|141415392|SUPERIORITY||||||=|0.66|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .66
70956016|NCT03208036|141415392|SUPERIORITY||||||=|0.46|||||||t-test, 2 sided|||Within group change assessed between baseline and 5.5 month assessment.||||= .46
70956017|NCT03208036|141415393|SUPERIORITY||||||=|0.68|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .68
70956018|NCT03208036|141415393|SUPERIORITY||||||=|0.45|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .45
70956019|NCT03208036|141415394|SUPERIORITY||||||=|0.81|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .81
70956020|NCT03208036|141415394|SUPERIORITY||||||=|0.31|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .31
70956021|NCT03208036|141415395|SUPERIORITY||||||=|0.79|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .79
70956022|NCT03208036|141415395|SUPERIORITY||||||=|0.5|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .50
71149976|NCT02148874|141792807|SUPERIORITY||Odds Ratio (OR)|1.26||||0.43|TWO_SIDED|95.0|0.71|2.24|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/ N).|Statistical analysis for influenza strain B/Massachusetts||2.24|0.71|0.43
71149977|NCT02148874|141792807|SUPERIORITY||Odds Ratio (OR)|1.08||||0.77|TWO_SIDED|95.0|0.63|1.87|||Regression, Logistic||Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/ N).|Statistical analysis for influenza strain B/Brisbane||1.87|0.63|0.77
71149978|NCT02148874|141792808|SUPERIORITY||Odds Ratio (OR)|1.39||||0.2|TWO_SIDED|95.0|0.84|2.32|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H1N1||2.32|0.84|0.20
71149979|NCT02148874|141792808|SUPERIORITY||Odds Ratio (OR)|1.09||||0.74|TWO_SIDED|95.0|0.66|1.8|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H3N2||1.80|0.66|0.74
71149980|NCT02148874|141792808|SUPERIORITY||Odds Ratio (OR)|1.89||||0.04|TWO_SIDED|95.0|1.04|3.44|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain B/Massachusetts||3.44|1.04|0.04
71149981|NCT02148874|141792808|SUPERIORITY||Odds Ratio (OR)|1.63||||0.13|TWO_SIDED|95.0|0.87|3.04|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain B/Brisbane||3.04|0.87|0.13
71149982|NCT02148874|141792809|SUPERIORITY||Odds Ratio (OR)|0.89||||0.64|TWO_SIDED|95.0|0.53|1.48|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H1N1||1.48|0.53|0.64
71149983|NCT02148874|141792809|SUPERIORITY||Odds Ratio (OR)|0.89||||0.67|TWO_SIDED|95.0|0.53|1.5|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H3N2||1.50|0.53|0.67
71149984|NCT02148874|141792809|SUPERIORITY||Odds Ratio (OR)|1.47||||0.14|TWO_SIDED|95.0|0.88|2.46|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain B/Massachusetts||2.46|0.88|0.14
71149985|NCT02148874|141792809|SUPERIORITY||Odds Ratio (OR)|0.74||||0.25|TWO_SIDED|95.0|0.44|1.24|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain B/Brisbane||1.24|0.44|0.25
71149986|NCT02592798|141792810|SUPERIORITY||Mean Difference (Final Values)|-7.7|||||TWO_SIDED|95.0|-46.8|33.3|||||Abatacept - Placebo for Double-Blind Period Day 113|||33.3|-46.8|
71149987|NCT02592798|141792810|SUPERIORITY||Mean Difference (Final Values)|-20.8|||||TWO_SIDED|95.0|-63.3|24.3|||||Abatacept - Placebo for Open Label Period Day 113|||24.3|-63.3|
71149988|NCT02592798|141792811|SUPERIORITY||Mean Difference (Final Values)|0.37|||||TWO_SIDED|95.0|-1.6495|2.3855|||||Abatacept - Placebo for Double-Blind Period Day 113|||2.3855|-1.6495|
71149989|NCT02592798|141792811|SUPERIORITY||Mean Difference (Final Values)|1.95|||||TWO_SIDED|95.0|-1.7933|5.6954|||||Abatacept - Placebo for Open Label Period Day 113|||5.6954|-1.7933|
71149990|NCT02592798|141792812|SUPERIORITY||Mean Difference (Final Values)|0.13|||||TWO_SIDED|95.0|-0.1483|0.4119|||||Abatacept - Placebo for Double-Blind Period Day 113|||0.4119|-0.1483|
71149991|NCT02592798|141792812|SUPERIORITY||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.5107|0.7551|||||Abatacept - Placebo for Open Label Period Day 113|||0.7551|-0.5107|
71149992|NCT02592798|141792813|SUPERIORITY||Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-44.7|44.7|||||Abatacept - Placebo for Open Label Period Day 113|||44.7|-44.7|
71149993|NCT02592798|141792814|SUPERIORITY||Mean Difference (Final Values)|-0.69|||||TWO_SIDED|95.0|-8.1395|6.7645|||||Abatacept - Placebo for Fatigue|||6.7645|-8.1395|
71149994|NCT02592798|141792814|SUPERIORITY||Mean Difference (Final Values)|-3.7|||||TWO_SIDED|95.0|-13.9402|6.5402|||||Abatacept - Placebo for Pain interference|||6.5402|-13.9402|
71149995|NCT02592798|141792814|SUPERIORITY||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-6.5736|4.5736|||||Abatacept - Placebo for Physical function|||4.5736|-6.5736|
71149996|NCT02592798|141792815|SUPERIORITY||Mean Difference (Final Values)|12.45|||||TWO_SIDED|95.0|-4.595|29.485|||||Abatacept - Placebo for Fatigue|||29.4850|-4.5950|
71149997|NCT02592798|141792815|SUPERIORITY||Mean Difference (Final Values)|7.14|||||TWO_SIDED|95.0|-2.5917|16.8717|||||Abatacept - Placebo for Pain interference|||16.8717|-2.5917|
71149998|NCT02592798|141792815|SUPERIORITY||Mean Difference (Final Values)|-0.88|||||TWO_SIDED|95.0|-12.1068|10.3468|||||Abatacept - Placebo for Mobility|||10.3468|-12.1068|
70956023|NCT03208036|141415396|SUPERIORITY||||||=|0.47|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .47
70956024|NCT03208036|141415396|SUPERIORITY||||||=|0.09|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .09
70956025|NCT03208036|141415396|SUPERIORITY||||||=|0.02|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .02
70956026|NCT03208036|141415396|SUPERIORITY||||||=|0.48|||||||t-test, 2 sided|||Within group change assessed between baseline and the 5.5 month assessment.||||= .48
70956027|NCT03208036|141415396|SUPERIORITY||||||=|0.66|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .66
70956028|NCT03208036|141415396|SUPERIORITY||||||=|0.46|||||||t-test, 2 sided|||Within group change assessed between baseline and the 5.5 month assessment.||||= .46
70956029|NCT03208036|141415397|SUPERIORITY||||||=|0.99|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .99
70956030|NCT03208036|141415397|SUPERIORITY||||||=|0.84|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .84
70956031|NCT03208036|141415398|SUPERIORITY||||||=|0.25|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .25
70956032|NCT03208036|141415398|SUPERIORITY||||||=|0.08|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .08
70956033|NCT03208036|141415398|SUPERIORITY||||||=|0.14|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .14
70956034|NCT03208036|141415398|SUPERIORITY||||||=|0.02|||||||t-test, 2 sided|||Within group change assessed between baseline and 5.5-month assessment.||||= .02
70956035|NCT03208036|141415398|SUPERIORITY||||||=|0.24|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .24
70956036|NCT03208036|141415398|SUPERIORITY||||||=|0.93|||||||t-test, 2 sided|||Within group change assessed between baseline and 5.5-month assessment.||||= .93
70956037|NCT03208036|141415399|SUPERIORITY||||||=|0.98|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .98
70956038|NCT03208036|141415399|SUPERIORITY||||||=|0.08|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .08
70956039|NCT03208036|141415399|SUPERIORITY||||||=|0.08|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .08
70956040|NCT03208036|141415399|SUPERIORITY||||||=|0.06|||||||t-test, 2 sided|||Within group change assessed between baseline and 5.5-month assessment.||||= .06
70956041|NCT03208036|141415399|SUPERIORITY||||||=|0.28|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .28
70956042|NCT03208036|141415399|SUPERIORITY||||||=|0.23|||||||t-test, 2 sided|||Within group change assessed between baseline and 5.5-month assessment.||||= .23
70956043|NCT04927247|141415410|OTHER||Difference in percentage|7.9||||0.6302|TWO_SIDED|95.0|-15.8|31.7|||Exact Cochran-Mantel-Haenszel test|||||31.7|-15.8|0.6302
70956044|NCT04927247|141415411|OTHER||Hazard Ratio (HR)|0.97||||0.9382|TWO_SIDED|95.0|0.43|2.16|||Stratified log-rank test|||||2.16|0.43|0.9382
70956045|NCT04927247|141415412|OTHER||Difference in percentage|-16.8||||0.1143|TWO_SIDED|95.0|-34.4|0.8|||Exact Cochran-Mantel-Haenszel test|||||0.8|-34.4|0.1143
70956046|NCT04927247|141415413|OTHER||Rate ratio|1.09||||0.7549|TWO_SIDED|95.0|0.63|1.89|||Negative binomial model|||||1.89|0.63|0.7549
70956047|NCT04664400|141415415|OTHER|Paired t test, testing whether the within participant difference is larger than 0.||||||0.043|||||||t-test, 1 sided|||||||0.043
70956048|NCT04664400|141415416|OTHER|Paired t test, testing whether the within participant difference is larger than 0.||||||0.036|||||||t-test, 1 sided|||||||0.036
70956049|NCT04664400|141415417|OTHER|Paired t test, testing whether the within participant difference is larger than 0.||||||0.012|||||||t-test, 1 sided|||||||0.012
70956050|NCT04664400|141415418|OTHER|Paired t test, testing whether the within participant difference is larger than 0.||||||0.835|||||||t-test, 1 sided|||||||0.835
70956051|NCT01011153|141415426|NON_INFERIORITY_OR_EQUIVALENCE|Sample sizes computed based on data from smaller studies provided 90% power for the comparison of sensitivity. Under the alternative hypothesis that the biopsy sensitivity of MelaFind would be 0.10 greater than the average biopsy/referral sensitivity of physicians (combined or separate), the probability that a 95% CI lies entirely above zero will be at least 90% when the standard error of the estimated difference is at most 0.0308.|Mean Difference (Final Values)|0.25|STANDARD_DEVIATION|0.03|<|0.0001|TWO_SIDED|95.0|0.18|0.32|||ANOVA|||Using True Positives/All Positives, sensitivity values were calculated for MelaFind as well as the average of the 110 dermatologists.||0.32|0.18|<0.0001
70956052|NCT01011153|141415427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|STANDARD_DEVIATION|0.04|<|0.0001|TWO_SIDED|95.0|0.19|0.34|||ANOVA|||Sensitivity||0.34|0.19|<0.0001
70956053|NCT01011153|141415427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_DEVIATION|0.04|<|0.0001|TWO_SIDED|95.0|0.16|0.31|||ANOVA|||Sensitivity||0.31|0.16|<0.0001
70956054|NCT01011153|141415427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|STANDARD_DEVIATION|0.03|<|0.0001|TWO_SIDED|95.0|0.19|0.33|||ANOVA|||Sensitivity||0.33|0.19|<0.0001
70956055|NCT01011153|141415427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|STANDARD_DEVIATION|0.05|<|0.0001|TWO_SIDED|95.0|-0.46|-0.25|||ANOVA|||Specificity||-0.25|-0.46|<0.0001
70956056|NCT01011153|141415427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_DEVIATION|0.05|<|0.0001|TWO_SIDED|95.0|-0.53|-0.31|||ANOVA|||Specificity||-0.31|-0.53|<0.0001
70956057|NCT01011153|141415427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_DEVIATION|0.05|<|0.0001|TWO_SIDED|95.0|-0.51|-0.3|||ANOVA|||Specificity||-0.30|-0.51|<0.0001
70956058|NCT01011153|141415428|SUPERIORITY_OR_OTHER||Kappa|0.313|STANDARD_ERROR_OF_MEAN|0.003||||0.0||||No comparison is being made.|ANOVA||There is no threshold level-this is a measurement of variability among responses provided by the participants.|||||
70956059|NCT01011153|141415428|SUPERIORITY_OR_OTHER||Kappa|0.276|STANDARD_ERROR_OF_MEAN|0.002||||0.0||||No comparison is being made|ANOVA||There is no threshold level-this is a measurement of variability among responses provided by the participants.|||||
70956060|NCT01011153|141415428|SUPERIORITY_OR_OTHER||Kappa|0.2|STANDARD_ERROR_OF_MEAN|0.003||||0.0||||No comparison is being made|ANOVA||There is no threshold level-this is a measurement of variability among responses provided by the participants.|||||
70956061|NCT01011153|141415428|SUPERIORITY_OR_OTHER||Kappa|0.256|STANDARD_ERROR_OF_MEAN|0.001||||0.0||||N/A - No comparison is being made|ANOVA||There is no threshold level-this is a measurement of variability among responses provided by the participants.|||||
70956062|NCT03014479|141415430|SUPERIORITY||Differences of Least Square Means|2.418||||0.2305|TWO_SIDED|95.0|-1.546|6.382|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors|||6.382|-1.546|0.2305
71149999|NCT00705016|141792824|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.885|TWO_SIDED|95.0|0.67|1.59||The Type I error was not taken into account, since the sample size calculation is based on selection theory.|Cox proportional hazards model|Stratification factor: Karnofsky performance status (KPS) \<80/\>=80||Sample size of 177 subjects was estimated such that the treatment group with the best PFS result had a 90% probability of emerging as the one with the smaller observed log Hazard ratio (HR), if there was an underlying difference of 2.2 months between the arms in the median PFS (7.8 months in the best group and 5.6 months in the other 2 groups). It was assumed that the accrual and follow-up time would take 1 year each, and that the drop-out rate was 8%.||1.59|0.67|0.885
70956063|NCT03014479|141415431|SUPERIORITY||Differences of Least Square Means|1.938||||0.4536|TWO_SIDED|95.0|-3.15|7.027|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors|||7.027|-3.150|0.4536
70956064|NCT03014479|141415432|SUPERIORITY||Differences of Least Square Means|4.16||||0.0896|TWO_SIDED|95.0|-0.649|8.968|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors|||8.968|-0.649|0.0896
70956065|NCT03014479|141415433|SUPERIORITY||Differences of Least Square Means|-0.563||||0.8506|TWO_SIDED|95.0|-6.448|5.323|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors|||5.323|-6.448|0.8506
70956066|NCT03014479|141415434|SUPERIORITY||Differences of Least Square Means|2.696||||0.3533|TWO_SIDED|95.0|-3.018|8.41|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors|||8.410|-3.018|0.3533
70956067|NCT03014479|141415436|SUPERIORITY||Differences of Least Square Means|0.613||||0.5451|TWO_SIDED|95.0|-1.38|2.605|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors|||2.605|-1.380|0.5451
70956068|NCT01781078|141415453|NON_INFERIORITY|The difference in the success rate between the 2 randomized groups was compared to 10% using a one-sided Farrington-Manning score test for non-inferiority at a significance level of 0.05.|difference|-0.3|||<|0.0001|ONE_SIDED|95.0||3.9|||Farrington-Manning score test|||||3.9||<0.0001
70956069|NCT01781078|141415454|NON_INFERIORITY|The difference in the success rate between the 2 randomized groups was compared to 10% using a one-sided Farrington-Manning score test for non-inferiority at a significance level of 0.05.|difference|-0.1||||0.0006|ONE_SIDED|95.0||5.0|||Farrington-Manning score test|||||5.0||0.0006
70956070|NCT01781078|141415454|NON_INFERIORITY|The difference in the success rate between the 2 randomized groups was compared to 10% using a one-sided Farrington-Manning score test for non-inferiority at a significance level of 0.05.|difference|0.0||||0.0002|ONE_SIDED|95.0||4.7|||Farrington-Manning score test|||||4.7||0.0002
70956071|NCT02217501|141415466|SUPERIORITY|||||||0.6595||||||Alpha of 0.05|Cochran-Mantel-Haenszel|||||||0.6595
70956072|NCT05121246|141415473|EQUIVALENCE|CI 90% of least squares geometric means must be entirely contained within the range \[80%-125%\].||||||||||||||||PK parameters will be determined using a non-compartmental analysis method. Bioequivalence between MB05 and EU-Synagis®, between MB05 and US-Synagis® and between EU-Synagis® and US-Synagis® will be established by analysis of variance for the PK parameters AUC0-inf, and Cmax.|PK parameters for each participant will be listed and summarised by treatment using descriptive statistics.|||
70956073|NCT05121246|141415474|EQUIVALENCE|CI 90% of least squares geometric means must be entirely contained within the range \[80%-125%\].||||||||||||||||PK parameters will be determined using a non-compartmental analysis method. Bioequivalence between MB05 and EU-Synagis®, between MB05 and US-Synagis® and between EU-Synagis® and US-Synagis® will be established by analysis of variance for the PK parameters AUC0-inf, and Cmax.|PK parameters for each participant will be listed and summarised by treatment using descriptive statistics.|||
70956074|NCT00432666|141415488|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.97|STANDARD_ERROR_OF_MEAN|1.49|<|0.001|TWO_SIDED|95.0|1.9|8.3|||Regression, Logistic|||The null hypothesis was equality of the chance (OR = 1) for a clinically relevant treatment effect between incobotulinumtoxinA (Xeomin) and placebo at Week 4 for wrist flexors. Responders were defined as subjects with an improvement of at least 1 point in the Ashworth score compared with Baseline. The dependent variable was the response to treatment, the independent variables were treatment, Ashworth score at the Baseline Visit, pre-treated patient status, gender, age, BMI, and pooled sites.||8.30|1.90|<0.001
70956075|NCT00605215|141415581|OTHER||Risk Ratio (RR)|0.823|STANDARD_ERROR_OF_MEAN|0.09||0.0746|TWO_SIDED|95.0|0.664|1.02||Threshold for significance at 0.05 level.|Negative Binomial Regression|||Analysis was performed using baseline-adjusted negative binomial regression, where a participant's number of relapses during the double-blind, placebo-controlled phase served as the response variable and an offset based on the log of participant's exposure in years was employed to adjust for variability of treatment exposure. The model included baseline EDSS score, log of (prior 2-year number of relapses+1) and CGR as covariates.||1.020|0.664|0.0746
70956076|NCT00605215|141415581|OTHER||Risk Ratio (RR)|0.741|STANDARD_ERROR_OF_MEAN|0.082||0.0067|TWO_SIDED|95.0|0.596|0.92|||Negative Binomial Regression|||Analysis was performed using baseline-adjusted negative binomial regression, where a participant's number of relapses during the double-blind, placebo-controlled phase served as the response variable and an offset based on the log of participant's exposure in years was employed to adjust for variability of treatment exposure. The model included baseline EDSS score, log of (prior 2-year number of relapses+1) and CGR as covariates.||0.920|0.596|0.0067
70956077|NCT02914275|141415589|NON_INFERIORITY|The non-inferiority criterion for the GMT ratio (adjusted analysis) was that the upper bound of the two-sided 95% confidence interval (CI) of the GMT ratio for the Comparator QIV GMT, divided by the Seqirus QIV GMT, should not exceed 1.5|Geometric Mean Titer Ratio|0.79|||||TWO_SIDED|95.0|0.72|0.88||||||Non-inferiority of immune responses to A/H1N1 vaccine strain measured in terms of Geometric Mean Titer ratios 28 days after the last vaccination||0.88|0.72|
70956078|NCT02914275|141415589|NON_INFERIORITY|The non-inferiority criterion for the GMT ratio (adjusted analysis) was that the upper bound of the two-sided 95% CI of the GMT ratio for the Comparator QIV GMT, divided by the Seqirus QIV GMT, should not exceed 1.5|Geometric Mean Titer Ratio|1.27|||||TWO_SIDED|95.0|1.15|1.42||||||Non-inferiority of immune responses to A/H3N2 vaccine strain measured in terms of Geometric Mean Titer ratios 28 days after the last vaccination||1.42|1.15|
70956079|NCT02914275|141415589|NON_INFERIORITY|The non-inferiority criterion for the GMT ratio (adjusted analysis) was that the upper bound of the two-sided 95% CI of the GMT ratio for the Comparator QIV GMT, divided by the Seqirus QIV GMT, should not exceed 1.5|Geometric Mean Titer Ratio|1.12|||||TWO_SIDED|95.0|1.01|1.24||||||Non-inferiority of immune responses to B/YAM vaccine strain measured in terms of Geometric Mean Titer ratios 28 days after the last vaccination||1.24|1.01|
70956080|NCT02914275|141415589|NON_INFERIORITY|The non-inferiority criterion for the GMT ratio (adjusted analysis) was that the upper bound of the two-sided 95% CI of the GMT ratio for the Comparator QIV GMT, divided by the Seqirus QIV GMT, should not exceed 1.5|Geometric Mean Titer Ratio|0.97|||||TWO_SIDED|95.0|0.86|1.09||||||Non-inferiority of immune responses to B/VIC vaccine strain measured in terms of Geometric Mean Titer ratios 28 days after the last vaccination||1.09|0.86|
71150000|NCT00705016|141792824|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.55||||0.054|TWO_SIDED|95.0|0.99|2.43||The Type I error was not taken into account, since the sample size calculation is based on selection theory.|Cox proportional hazards model|Stratification factor: Karnofsky performance status (KPS) \<80/\>=80||Sample size of 177 subjects was estimated such that the treatment group with the best PFS result had a 90% probability of emerging as the one with the smaller observed log HR, if there was an underlying difference of 2.2 months between the arms in the median PFS (7.8 months in the best group and 5.6 months in the other 2 groups). It was assumed that the accrual and follow-up time would take 1 year each, and that the drop-out rate was 8%.||2.43|0.99|0.054
71150001|NCT00705016|141792825|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.8|TWO_SIDED|95.0|0.61|1.47||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cox proportional hazards model|||||1.47|0.61|0.800
71150002|NCT00705016|141792825|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.878|TWO_SIDED|95.0|0.66|1.63|||Cox proportional hazards model|||||1.63|0.66|0.878
71150003|NCT00705016|141792826|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.595||||0.205|TWO_SIDED|95.0|0.776|3.276||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cochran-Mantel-Haenszel|||||3.276|0.776|0.205
71150004|NCT00705016|141792826|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.671||||0.317|TWO_SIDED|95.0|0.307|1.465||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cochran-Mantel-Haenszel|||||1.465|0.307|0.317
71150005|NCT00705016|141792827|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.396||||0.476|TWO_SIDED|95.0|0.551|3.539||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cochran-Mantel-Haenszel|||||3.539|0.551|0.476
71150006|NCT00705016|141792827|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.668||||0.347|TWO_SIDED|95.0|0.287|1.555||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cochran-Mantel-Haenszel|||||1.555|0.287|0.347
71150007|NCT00705016|141792828|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.294|TWO_SIDED|95.0|0.84|1.81||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cox proportional hazards model|||||1.81|0.84|0.294
71150008|NCT00705016|141792828|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.73||||0.007|TWO_SIDED|95.0|1.16|2.57||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cox proportional hazards model|||||2.57|1.16|0.007
71150009|NCT00705016|141792829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.391|TWO_SIDED|95.0|0.71|2.39||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cox proportional hazards model|||||2.39|0.71|0.391
71150010|NCT00705016|141792829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.6||||0.007|TWO_SIDED|95.0|1.3|5.21||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cox proportional hazards model|||||5.21|1.30|0.007
71150011|NCT02233517|141792831|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.51||0.84|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.|||||0.84
71150012|NCT02233517|141792831|SUPERIORITY||Slope|0.23|STANDARD_ERROR_OF_MEAN|0.52|<|0.44|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||<0.44
71150013|NCT02233517|141792831|SUPERIORITY||Slope|0.5|STANDARD_ERROR_OF_MEAN|0.51||0.33|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.33
71150014|NCT02233517|141792832|SUPERIORITY|Estimation parameter is interaction of session by therapy, or estimate of difference in mean between CBT and PCT per time point. Positive value is less decrease over time in CBT arm (greater decrease in anger over time in PCT).|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.1||0.26|TWO_SIDED||||||Mixed Models Analysis|||Multilevel model of therapy type (1=CBT, 2=PCT), gender, and time on DAR scores, using data from baseline, 12 sessions, post-treatment, 3-month and 6-month follow up.||||0.26
71150015|NCT02233517|141792833|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|1.16||0.9|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.|||||0.90
71150016|NCT02233517|141792833|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|1.16||0.85|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||0.85
71150017|NCT02233517|141792833|SUPERIORITY||Mean Difference (Net)|0.31|STANDARD_ERROR_OF_MEAN|1.16||0.79|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.79
71150018|NCT02233517|141792834|SUPERIORITY||Mean Difference (Net)|-2.3|STANDARD_DEVIATION|3.2||0.05|TWO_SIDED|95.0|-4.5|-0.002|||t-test, 2 sided|||This is the comparison of change in means for cognitive-behavioral vs. present-centered therapy from baseline to post-treatment for the Extent of Participation scale.||-.002|-4.5|0.05
71150019|NCT02233517|141792834|SUPERIORITY||Mean Difference (Net)|-0.47|STANDARD_DEVIATION|2.09||0.53|TWO_SIDED|95.0|-2.03|1.08|||t-test, 2 sided|||This is the comparison of change in means for cognitive-behavioral vs. present-centered therapy from baseline to post-treatment for the Perceived Limitations scale.||1.08|-2.03|0.53
71150020|NCT02233517|141792834|SUPERIORITY||Mean Difference (Net)|-0.58|STANDARD_DEVIATION|2.42||0.5|TWO_SIDED|95.0|-2.3|1.14|||t-test, 2 sided|||This is the comparison of change in means for cognitive-behavioral vs. present-centered therapy from baseline to post-treatment for the Satisfaction scale.||1.14|-2.30|0.50
71150021|NCT02233517|141792835|SUPERIORITY||Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED||||||Mixed Models Analysis||The estimation parameter of 0.28 indicates that at each of the 16 time points, participants in the CBT arm had 0.28 point less of a decrease in disability than those in PCT arm.|Estimation parameter is interaction of session by therapy, or estimate of difference in mean between CBT and PCT per time point. Positive value is less decrease over time in CBT arm (greater decrease in anger over time in PCT).||||<0.0001
71150022|NCT02233517|141792836|SUPERIORITY||Mean Difference (Net)|1.45|STANDARD_ERROR_OF_MEAN|2.71||0.59|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.|||||0.59
71150023|NCT02233517|141792836|SUPERIORITY||Mean Difference (Net)|1.37|STANDARD_ERROR_OF_MEAN|2.71||0.61|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||0.61
71150024|NCT02233517|141792836|SUPERIORITY||Mean Difference (Net)|-0.89|STANDARD_ERROR_OF_MEAN|2.71||0.74|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.74
71150025|NCT02233517|141792837|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.16||0.25|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.|||||0.25
71150026|NCT02233517|141792837|SUPERIORITY||Mean Difference (Net)|0.006|STANDARD_ERROR_OF_MEAN|0.16||0.97|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||0.97
71150027|NCT02233517|141792837|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.17||0.69|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.69
71150028|NCT02233517|141792838|SUPERIORITY||Mean Difference (Net)|-0.71|STANDARD_ERROR_OF_MEAN|0.66||0.29|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.|||||0.29
71150029|NCT02233517|141792838|SUPERIORITY||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.66||0.44|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||0.44
71150030|NCT02233517|141792838|SUPERIORITY||Mean Difference (Net)|-1.06|STANDARD_ERROR_OF_MEAN|0.66||0.11|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.11
71150031|NCT02233517|141792839|SUPERIORITY||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.12||0.16|TWO_SIDED||||||Mixed Models Analysis||Estimation parameter is interaction of session by therapy, or estimate of difference in mean between CBT and PCT per time point. Positive value is less decrease over time in CBT arm (greater decrease in PTSD in PCT).|Multilevel model of therapy type (1=CBT, 2=PCT), gender, and time on PCL Total scores, using data from baseline, 12 sessions, post-treatment, 3-month and 6-month follow up.||||0.16
71150032|NCT02233517|141792840|SUPERIORITY||Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.37||0.45|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.|||||0.45
71150033|NCT02233517|141792840|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.37||0.55|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||0.55
71150034|NCT02233517|141792840|SUPERIORITY||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.37||0.87|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.87
71150035|NCT02233517|141792841|SUPERIORITY||Mean Difference (Net)|-0.71|STANDARD_ERROR_OF_MEAN|1.04||0.49|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment.|||||0.49
71150036|NCT02233517|141792841|SUPERIORITY||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|1.04||0.7|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||0.70
71150037|NCT02233517|141792841|SUPERIORITY||Mean Difference (Net)|-0.78|STANDARD_ERROR_OF_MEAN|1.04||0.45|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.45
71150038|NCT01967940|141792843|SUPERIORITY|Enrollment into this study was stopped early due to the challenge of recruiting a sufficient number of participants who met the eligibility criteria. The actual number of enrolled is 55, among them 43 enrolled in the Randomized Cohort. Based on the actual enrollment numbers, the power to detect a 35% difference drops to 51%, under the same assumptions in the original sample size calculations.|Difference in proportions|60.7|||<|0.001|TWO_SIDED|95.0|42.6|78.8|||Fisher Exact||The 95% confidence interval was estimated based on unconditional exact method using 2 inverted 1-sided tests with the standardized statistic.|A sample size of 90 participants, randomized in a 2:1 ratio, achieves 89% power to detect a 35% difference in the proportion of participants with HIV-1 RNA decreases from baseline exceeding 0.5 log10 between the TAF and placebo arms at Day 10. Sample size and power computation was based on the assumption that 50% of participants in the TAF arm and 15% of participants in the placebo arm achieved a reduction exceeding 0.5 log10 HIV-1 RNA.||78.8|42.6|<0.001
71150039|NCT00942604|141792863|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
71150040|NCT00942604|141792864|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
71150041|NCT00363480|141792889|SUPERIORITY_OR_OTHER||Percentage diffrence|-30.6|||<|0.0001|TWO_SIDED|95.0|-37.89|-23.29|||McNemar|||Comparison between GOAL and ACT response||-23.29|-37.89|<0.0001
71150042|NCT00363480|141792890|SUPERIORITY_OR_OTHER||t-Distribution|50.2|||||TWO_SIDED|95.0|43.15|57.32||||||||57.32|43.15|
71150043|NCT05567783|141792926|SUPERIORITY||Relative risk reduction (RRR, %)|15.85||||0.5552|TWO_SIDED|95.0|-49.27|52.56||two-sided, alpha=0.05|Poisson regression|Estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model|RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group was the only factor in the model|||52.56|-49.27|0.5552
71150044|NCT05567783|141792926|SUPERIORITY||Relative risk reduction (RRR, %)|3.78|||||TWO_SIDED|95.0|-67.23|44.63|||||RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model; 95% CI are nominal and not adjusted for multiple comparisons.|||44.63|-67.23|
71150045|NCT05567783|141792934|SUPERIORITY||Relative risk reduction (RRR, %)|57.23|||||TWO_SIDED|95.0|-2.51|82.15|||||RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model; 95%CI are nominal and not adjusted for multiple comparisons.|||82.15|-2.51|
71150046|NCT05567783|141792934|SUPERIORITY||Relative risk reduction (RRR, %)|11.45|||||TWO_SIDED|95.0|-76.25|55.51|||||RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model; 95% CI are nominal and not adjusted for multiple comparisons.|||55.51|-76.25|
71150047|NCT05567783|141792935|SUPERIORITY||Relative risk reduction (RRR, %)|44.13|||||TWO_SIDED|95.0|-50.49|79.26|||||RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model; 95%CI are nominal and not adjusted for multiple comparisons.|||79.26|-50.49|
71150048|NCT05567783|141792935|SUPERIORITY||Relative risk reduction (RRR, %)|-9.8|||||TWO_SIDED|95.0|-147.41|51.27|||||RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model; 95% CI are nominal and not adjusted for multiple comparisons.|||51.27|-147.41|
71150049|NCT04916587|141792947|SUPERIORITY||Risk Difference (RD)|11.6|||||TWO_SIDED|95.0|10.6|12.6||||||||12.6|10.6|
71150050|NCT04916587|141792948|SUPERIORITY||Risk Difference (RD)|7.5|||||TWO_SIDED|95.0|6.6|8.3||||||||8.3|6.6|
71150051|NCT04916587|141792949|SUPERIORITY||Odds Ratio (OR)|0.36||||0.03|TWO_SIDED|90.0|0.14|0.89|||Mixed Models Analysis|||||0.89|0.14|0.03
71150052|NCT00940771|141792953|OTHER|Friedman's Test|Chi Square|12.3||||0.006|TWO_SIDED||||||Friedman's Test|3 degrees of freedom.||||||.006
71150053|NCT00940771|141792953|OTHER|Post Hoc testing Post hoc Wilcoxon Signed Rank tests||||||0.007|||||||Wilcoxon Signed Rank|Z=-2.701||Nul lHypothesis that there is no difference between specific time points.||||.007
71150054|NCT00940771|141792954|OTHER|Friedman's test with 3 df||||||0.356|||||||Friedman's Test|3 degrees of freedom||||||.356
71150055|NCT00940771|141792955|OTHER||Chi-square|1.0||||0.801|TWO_SIDED||||||Friedman's test|3 degrees of freedom|1.0 is the actual calculated Chi-X value, not the p value.|The null hypothesis was that there was a difference. We were looking for no difference between before and after switch.||||.801
71150056|NCT00940771|141792956|OTHER|Friedman's test||||||0.075||||||a priori threshold for statistical significance 0.05|Friedman's test|3 degrees of freedom||||||.075
71150057|NCT02593006|141792962|SUPERIORITY||Risk Difference (RD)|10.3|||>|0.05|TWO_SIDED|95.0|-3.2|23.8|||Propensity weighted regression model|||||23.8|-3.2|>0.05
71150058|NCT02593006|141792963|SUPERIORITY|||||||0.04||||||Global test of interaction between time and treatment group.|Mixed Models Analysis|||||||0.04
71150059|NCT02048670|141792964|SUPERIORITY|||||||0.005|||||||Kruskal-Wallis|||Condition 1 - eyes open, visual surround locked, platform locked||||0.005
71150060|NCT02048670|141792964|SUPERIORITY|||||||0.006|||||||Kruskal-Wallis|||Condition 2 - eyes closed, visual surround locked, platform locked||||0.006
71150061|NCT02048670|141792964|SUPERIORITY|||||||0.051|||||||Kruskal-Wallis|||Condition 3 - eyes open, visual surround unlocked, platform locked||||0.051
71150062|NCT02048670|141792964|SUPERIORITY|||||||0.173|||||||Kruskal-Wallis|||Condition 4 - eyes open, visual surround locked, platform unlocked||||0.173
71150063|NCT02048670|141792964|SUPERIORITY|||||||0.985|||||||Kruskal-Wallis|||Condition 5 - eyes closed, visual surround locked, platform unlocked||||0.985
71150064|NCT02048670|141792964|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||Condition 6 - eyes open, visual surround unlocked, platform unlocked||||0.003
71150065|NCT00630838|141793001|SUPERIORITY_OR_OTHER||||||=|0.897|TWO_SIDED||||||t-test, 2 sided|||||||=0.897
71150066|NCT01424072|141793006|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||It was verified the normality of data distribution and the homogeneity of variance.|ANOVA|||The main objective was to compare the difference among the control group, seeds and needles and to recognize significant outcomes of auriculotherapy by seeds or needles.||||0.023
70875753|NCT01500629|141235338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.35|TWO_SIDED|95.0|-0.11|0.3|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.30|-0.11|0.350
70875754|NCT01500629|141235339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.947|TWO_SIDED|95.0|-0.36|0.34|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.34|-0.36|0.947
70875755|NCT01500629|141235340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.651|TWO_SIDED|95.0|-0.3|0.19|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.19|-0.30|0.651
70875756|NCT01500629|141235345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.261|TWO_SIDED|95.0|-1.3|0.38|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.38|-1.30|0.261
70956081|NCT02914275|141415590|NON_INFERIORITY|The noninferiority criterion for the SCR difference was that the upper bound of the two-sided 95% CI on the difference between SCRs for Comparator QIV minus the Seqirus QIV SCR should not exceed 10%.|Seroconversion Rate Difference|-10.3|||||TWO_SIDED|95.0|-15.4|-5.1||||||Non-inferiority of immune responses to A/H1N1 vaccine strain measured in terms of Seroconversion Rate Difference 28 days after the last vaccination||-5.1|-15.4|
70875757|NCT01500629|141235346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.481|TWO_SIDED|95.0|-0.51|1.04|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||1.04|-0.51|0.481
70875758|NCT01500629|141235347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.961|TWO_SIDED|95.0|-0.85|0.89|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.89|-0.85|0.961
70875759|NCT01500629|141235348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.546|TWO_SIDED|95.0|-0.57|1.04|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||1.04|-0.57|0.546
70956082|NCT02914275|141415590|NON_INFERIORITY|The noninferiority criterion for the SCR difference was that the upper bound of the two-sided 95% CI on the difference between SCRs for Comparator QIV minus the Seqirus QIV SCR should not exceed 10%.|Seroconversion Rate Difference|2.6|||||TWO_SIDED|95.0|-2.54|7.8||||||Non-inferiority of immune responses to A/H3N2 vaccine strain measured in terms of Seroconversion Rate Difference 28 days after the last vaccination||7.8|-2.54|
70956083|NCT02914275|141415590|NON_INFERIORITY|The noninferiority criterion for the SCR difference was that the upper bound of the two-sided 95% CI on the difference between SCRs for Comparator QIV minus the Seqirus QIV SCR should not exceed 10%.|Seroconversion Rate Difference|3.1|||||TWO_SIDED|95.0|-2.1|8.2||||||Non-inferiority of immune responses to B/YAM vaccine strain measured in terms of Seroconversion Rate Difference 28 days after the last vaccination||8.2|-2.1|
71150067|NCT01424072|141793007|SUPERIORITY_OR_OTHER||||||,|0||95.0||||It was verified the normality of data distribution and the homogeneity of variance.|ANOVA|This result was only to the domain Social Support.||It was carried out the analysis of variance (ANOVA) among the groups in the 3rd assessment (after 60 days) and at the follow up (after 75 days). The main objective was to compare the difference among the control group, seeds and needles and to recognize significant outcomes of auriculotherapy by seeds or needles.||||0,022
71150068|NCT01424072|141793008|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||It was verified the normality of data distribution and the homogeneity of variance.|ANOVA|||It was carried out the analysis of variance (ANOVA) among the groups at the follow up (after 75 days). The main objective was to compare the difference among the control group, seeds and needles and to recognize significant outcomes of auriculotherapy by seeds or needles.||||0.039
71150069|NCT01424072|141793008|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||ANOVA|It was carried out the analysis of variance (ANOVA) among the groups at the follow up and then it was used the post hoc test.||Coping Strategy: Confrontation domain||||0.029
70956084|NCT02914275|141415590|NON_INFERIORITY|The noninferiority criterion for the SCR difference was that the upper bound of the two-sided 95% CI on the difference between SCRs for Comparator QIV minus the Seqirus QIV SCR should not exceed 10%.|Seroconversion Rate Difference|0.9|||||TWO_SIDED|95.0|-4.2|6.1||||||Non-inferiority of immune responses to B/VIC vaccine strain measured in terms of Seroconversion Rate Difference 28 days after the last vaccination||6.1|-4.2|
70956085|NCT02366468|141415601|NON_INFERIORITY|non-inferiority margin: -4 letters|Median Difference (Final Values)|-0.9||||0.002|TWO_SIDED|95.0|-3.04|1.27|||ANCOVA|including study treatment (DI, PRN) and center as factors and baseline BCVA as continuous covariate.||The primary objective was to demonstrate that the mean visit-averaged change from baseline of BCVA over month 1 to treatment completion for the DI arm was non-inferior to the PRN arm.||1.27|-3.04|0.002
70956086|NCT02366468|141415605|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.62|TWO_SIDED|95.0|-17.1|28.56|||ANCOVA|containing the baseline values of the dependent variables as continuous covariates, and center and treatment as categorical covariates||||28.56|-17.10|0.620
70956087|NCT02366468|141415606|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.925|TWO_SIDED|95.0|-33.66|30.59|||ANCOVA|containing the baseline values of the dependent variables as continuous covariates, and center and treatment as categorical covariates||||30.59|-33.66|0.925
70956088|NCT00105001|141415623|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09|TWO_SIDED|||||Overall test of homogeneity among arms, reflecting events over the entire period of follow-up|Regression, Cox|||||||0.09
70956089|NCT00105001|141415623|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69||||0.1|TWO_SIDED|95.0|0.4|1.1|||Regression, Cox||HR for Arm II relative to Arm I, reflecting events over the entire period of follow-u\[|||1.1|0.4|0.10
70956090|NCT00105001|141415623|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.62||||0.04|TWO_SIDED|95.0|0.6|1.0|||Regression, Cox||HR for Arm III relative to Arm I, reflecting events over the entire period of follow-up|||1.0|0.6|0.04
71150070|NCT04922216|141793043|SUPERIORITY||Mean Difference (Net)|0.3||||0.52|TWO_SIDED|95.0|-0.61|1.2|||Mixed Models Analysis|Degrees of freedom (2,622)|Standard dietary monitoring coded as 0 (reference) and simplified dietary monitoring coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 1 (dietary self-monitoring) using linear mixed models comparing the effect of standard dietary monitoring to simplified dietary monitoring on weight change over time (from baseline to 6 months).||1.20|-0.61|0.52
70956091|NCT00105001|141415624|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55|TWO_SIDED|||||Overall test of homogeneity among arms, reflecting events over the entire period of follow-up|Regression, Cox|||||||0.55
70956092|NCT00105001|141415625|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED|||||Overall test of homogeneity among arms, reflecting events over the entire period of follow-up|Regression, Cox|||||||0.009
70956093|NCT00105001|141415625|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.51|TWO_SIDED|95.0|0.5|1.4|||Regression, Cox||HR for Arm II relative to Arm I, reflecting events over the entire period of follow-up|||1.4|0.5|0.51
70956094|NCT00105001|141415625|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.47||||0.004|TWO_SIDED|95.0|0.3|0.8|||Regression, Cox||HR for Arm III relative to Arm I, reflecting events over the entire period of follow-up|||0.8|0.3|0.004
70956095|NCT00105001|141415626|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93|TWO_SIDED|||||Overall test of homogeneity among arms, reflecting events over the entire period of follow-up|Regression, Cox|||||||0.93
70956096|NCT00105001|141415627|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96|TWO_SIDED|||||Overall test of homogeneity among arms, reflecting events over the entire period of follow-up|Regression, Cox|||||||0.96
70956097|NCT01534689|141415668|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
70956098|NCT01534689|141415669|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||results at 12 weeks compared to baseline||||<0.0001
70956099|NCT00006011|141415670|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.69|1.17||||||"Primary outcome is measured as a treatment hazard ratio stratified by stage and assuming proportional hazards.~Recurrence-free survival hazard ratio: Arm 2 is relative to Arm 1."||1.17|0.69|
70956100|NCT05383508|141415703|OTHER||Geometric LS Mean Ratio (%)|17.05|||||TWO_SIDED|95.0|10.69|27.19||95% confidence intervals are provided for this analysis.|Mixed Models Analysis|The model included terms for sequence, period, and product exposure as fixed effects and subject as a categorical random effect.|Analysis was performed on log transformed data with Kenward Roger degrees of freedom approximation. Ratio and related 95% CI were derived by exponentiating the estimates obtained on the log scale.|The objective of this study was to determine the Cmax ratio of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||27.19|10.69|
70956101|NCT05383508|141415703|OTHER||Geometric LS Mean Ratio (%)|19.47|||||TWO_SIDED|95.0|11.89|31.87||95% confidence intervals are provided for this analysis.|Mixed Models Analysis|The model included terms for sequence, period, and product exposure as fixed effects and subject as a categorical random effect.|Analysis was performed on log transformed data with Kenward Roger degrees of freedom approximation. Ratio and related 95% CI were derived by exponentiating the estimates obtained on the log scale.|The objective of this study was to determine the Cmax ratio of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||31.87|11.89|
70956102|NCT05383508|141415704|OTHER||Median Difference (Net)|3.0|||||TWO_SIDED|95.0|0.0|11.0||95% confidence intervals are provided for this analysis.|Wilcoxon signed rank test||Hodges-Lehmann estimator of location shift and Moses 95% CI|The objective of this study was to determine the Tmax difference of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||11.00|0.00|
70956103|NCT05383508|141415704|OTHER||Mean Difference (Net)|2.0|||||TWO_SIDED|95.0|0.0|4.0||95% confidence intervals are provided for this analysis.|Wilcoxon signed rank test||Hodges-Lehmann estimator of location shift and Moses 95% CI|The objective of this study was to determine the Tmax difference of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||4.00|0.00|
70956104|NCT05383508|141415705|OTHER||Geometric LS Mean Ratio (%)|28.29|||||TWO_SIDED|95.0|16.0|50.04||95% confidence intervals are provided for this analysis.|Mixed Models Analysis|The model included terms for sequence, period, and product exposure as fixed effects and subject as a categorical random effect.|Analysis was performed on log transformed data with Kenward Roger degrees of freedom approximation. Ratio and related 95% CI were derived by exponentiating the estimates obtained on the log scale.|The objective of this study was to determine the AUC0-infinity ratio of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||50.04|16.00|
70956105|NCT05383508|141415705|OTHER||Geometric LS Mean Ratio (%)|26.16|||||TWO_SIDED|95.0|12.74|53.69||95% confidence intervals are provided for this analysis.|Mixed Models Analysis|The model included terms for sequence, period, and product exposure as fixed effects and subject as a categorical random effect.|Analysis was performed on log transformed data with Kenward Roger degrees of freedom approximation. Ratio and related 95% CI were derived by exponentiating the estimates obtained on the log scale.|The objective of this study was to determine the AUC0-infinity ratio of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||53.69|12.74|
70956106|NCT05383508|141415706|OTHER||Geometric LS Mean Ratio (%)|10.84|||||TWO_SIDED|95.0|5.57|21.1||95% confidence intervals are provided for this analysis.|Mixed Models Analysis|The model included terms for sequence, period, and product exposure as fixed effects and subject as a categorical random effect.|Analysis was performed on log transformed data with Kenward Roger degrees of freedom approximation. Ratio and related 95% CI were derived by exponentiating the estimates obtained on the log scale.|The objective of this study was to determine the maximum ratio of background-corrected concentration over time of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||21.10|5.57|
70956107|NCT05383508|141415706|OTHER||Geometric LS Mean Ratio (%)|16.83|||||TWO_SIDED|95.0|9.93|28.53||95% confidence intervals are provided for this analysis.|Mixed Models Analysis|The model included terms for sequence, period, and product exposure as fixed effects and subject as a categorical random effect.|Analysis was performed on log transformed data with Kenward Roger degrees of freedom approximation. Ratio and related 95% CI were derived by exponentiating the estimates obtained on the log scale.|The objective of this study was to determine the maximum ratio of background-corrected concentration over time of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||28.53|9.93|
70956108|NCT01859988|141415708|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-55.7|STANDARD_ERROR_OF_MEAN|6.74|<|0.0001|TWO_SIDED|95.0|-68.9|-42.4||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|LS mean and standard error were obtained using analysis of covariance (ANCOVA) model with treatment and randomization strata (moderate vs severe;Japan vs rest of world) and relevant baseline values as covariates. Multiplicity was controlled using hierarchical testing procedure:highest dose vs. placebo was tested first. Comparison order was 300 mg qw,300 mg q2w,200 mg q2w,300 mg q4w \& 100 mg q4w, vs placebo respectively. Testing continues only if previous comparison was statistically significant.||-42.4|-68.9|<0.0001
71150071|NCT04922216|141793043|SUPERIORITY||Mean Difference (Net)|-0.28||||0.54|TWO_SIDED|95.0|-1.19|0.63|||Mixed Models Analysis|Degrees of freedom (2,622)|Weekly adaptive goals coded as 0 (reference) and daily adaptive goals coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 2 (adaptive activity goals) using linear mixed models comparing the effect of weekly adaptive activity goals versus daily adaptive activity goals on weight change over time (from baseline to 6 months).||0.63|-1.19|0.54
71150072|NCT04922216|141793043|SUPERIORITY||Mean Difference (Net)|0.4||||0.39|TWO_SIDED|95.0|-0.5|1.31|||Mixed Models Analysis|Degrees of freedom (2,622)|Fixed message decision points coded as 0 (reference) and adaptive message decision points coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 3 (message decision points) using linear mixed models comparing the effect of weekly adaptive activity goals versus daily adaptive activity goals on weight change over time (from baseline to 6 months).||1.31|-0.50|0.39
70956109|NCT01859988|141415708|SUPERIORITY_OR_OTHER||LS mean difference|-50.1|STANDARD_ERROR_OF_MEAN|6.67|<|0.0001|TWO_SIDED|95.0|-63.3|-37.0||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-37.0|-63.3|<0.0001
71150073|NCT04922216|141793043|SUPERIORITY||Mean Difference (Net)|0.39||||0.7|TWO_SIDED|95.0|-0.52|1.3|||Mixed Models Analysis|Degrees of freedom (2,622)|Standard decision rules coded as 0 (reference) and adaptive decision rules coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 4 (message decision rules) using linear mixed models comparing the effect of standard decision rules to adaptive decision rules on weight change over time (from baseline to 6 months).||1.30|-0.52|0.70
71150074|NCT04922216|141793043|SUPERIORITY||Mean Difference (Net)|-0.55||||0.47|TWO_SIDED|95.0|-1.45|0.36|||Mixed Models Analysis|Degrees of freedom (2,622)|No choice points coded as 0 (reference) and Choice coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 5 (participant choice) using linear mixed models comparing the effect of no participant message choice versus participant message choice on weight change over time (from baseline to 6 months).||0.36|-1.45|0.47
71150075|NCT04922216|141793044|SUPERIORITY||Mean Difference (Net)|0.24||||0.43|TWO_SIDED|95.0|-0.36|0.84|||Mixed Models Analysis|DF (2,622)|Standard dietary monitoring coded as 0 (reference) and simplified dietary monitoring coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 1 (dietary self-monitoring) using linear mixed models comparing the effect of standard dietary monitoring to simplified dietary monitoring on weight change over time (from baseline to 3 months).||0.84|-0.36|0.43
71150076|NCT04922216|141793044|SUPERIORITY||Mean Difference (Net)|-0.42||||0.17|TWO_SIDED|95.0|-1.01|0.18|||Mixed Models Analysis|DF (2,622)|Weekly adaptive goals coded as 0 (reference) and daily adaptive goals coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 2 (adaptive activity goals) using linear mixed models comparing the effect of weekly adaptive activity goals versus daily adaptive activity goals on weight change over time (from baseline to 3 months).||0.18|-1.01|0.17
71150077|NCT04922216|141793044|SUPERIORITY||Mean Difference (Net)|0.53||||0.08|TWO_SIDED|95.0|-0.06|1.13|||Mixed Models Analysis|DF (2,622)|Fixed message decision points coded as 0 (reference) and adaptive message decision points coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 3 (message decision points) using linear mixed models comparing the effect of weekly adaptive activity goals versus daily adaptive activity goals on weight change over time (from baseline to 3 months).||1.13|-0.06|0.08
71150078|NCT04922216|141793044|SUPERIORITY||Mean Difference (Net)|0.32||||0.58|TWO_SIDED|95.0|-0.28|0.91|||Mixed Models Analysis|DF (2,622)|Standard decision rules coded as 0 (reference) and adaptive decision rules coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 4 (message decision rules) using linear mixed models comparing the effect of standard decision rules to adaptive decision rules on weight change over time (from baseline to 3 months).||0.91|-0.28|0.58
71150079|NCT04922216|141793044|SUPERIORITY||Mean Difference (Net)|-0.32||||0.55|TWO_SIDED|95.0|-0.91|0.28|||Mixed Models Analysis|DF (2,622)|No choice points coded as 0 (reference) and Choice coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 5 (participant choice) using linear mixed models comparing the effect of no participant message choice versus participant message choice on weight change over time (from baseline to 3 months).||0.28|-0.91|0.55
71150080|NCT04922216|141793045|SUPERIORITY||Odds Ratio (OR)|0.99||||0.95|TWO_SIDED|95.0|0.7|1.39|||Chi-squared|DF (1)|Standard dietary monitoring coded as 0 (reference) and simplified dietary monitoring coded as 1; an odds ratio \> 1 indicates that the odds of achieving 5% weight loss are higher in the group coded as 1.|Chi-square test of the difference in proportion reaching 5% weight loss from baseline to 6 months between standard dietary monitoring and simplified dietary monitoring (factor 1).||1.39|0.70|0.95
71150081|NCT04922216|141793045|SUPERIORITY||Odds Ratio (OR)|1.46||||0.03|TWO_SIDED|95.0|1.03|2.05|||Chi-squared|DF (1)|Weekly adaptive activity goals coded as 0 (reference) and daily adaptive activity goals coded as 1; an odds ratio \> 1 indicates that the odds of achieving 5% weight loss are higher in the group coded as 1.|Chi-square test of the difference in proportion reaching 5% weight loss from baseline to 6 months between weekly adaptive activity goals and daily adaptive activity goals (factor 2).||2.05|1.03|0.03
71150082|NCT04922216|141793045|SUPERIORITY||Odds Ratio (OR)|0.85||||0.36|TWO_SIDED|95.0|0.6|1.2|||Chi-squared|DF (1)|Fixed decision points coded as 0 (reference) and adaptive decision points coded as 1; an odds ratio \> 1 indicates that the odds of achieving 5% weight loss are higher in the group coded as 1.|Chi-square test of the difference in proportion reaching 5% weight loss from baseline to 6 months between fixed message decision points and adaptive message decision points (factor 3).||1.20|0.60|0.36
71150083|NCT04922216|141793045|SUPERIORITY||Odds Ratio (OR)|1.01||||0.95|TWO_SIDED|95.0|0.72|1.42|||Chi-squared|DF (1)|Standard decision rules coded as 0 (reference) and adaptive decision rules coded as 1; an odds ratio \> 1 indicates that the odds of achieving 5% weight loss are higher in the group coded as 1.|Chi-square test of the difference in proportion reaching 5% weight loss from baseline to 6 months between standard message decision rules and adaptive message decision rules (factor 4).||1.42|0.72|0.95
70956110|NCT01859988|141415708|SUPERIORITY_OR_OTHER||LS mean difference|-47.4|STANDARD_ERROR_OF_MEAN|6.76|<|0.0001|TWO_SIDED|95.0|-60.6|-34.1||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 200 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-34.1|-60.6|<0.0001
71150084|NCT04922216|141793045|SUPERIORITY||Odds Ratio (OR)|1.2||||0.29|TWO_SIDED|95.0|0.85|1.69|||Chi-squared|DF (1)|No message choice coded as 0 (reference) and message choice coded as 1; an odds ratio \> 1 indicates that the odds of achieving 5% weight loss are higher in the group coded as 1.|Chi-square test of the difference in proportion reaching 5% weight loss from baseline to 6 months between no message choice and message choice (factor 5).||1.69|0.85|0.29
70956111|NCT01859988|141415708|SUPERIORITY_OR_OTHER||LS mean difference|-45.4|STANDARD_ERROR_OF_MEAN|6.66|<|0.0001|TWO_SIDED|95.0|-58.5|-32.3||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q4w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-32.3|-58.5|<0.0001
71150085|NCT00904033|141793114|OTHER|||||||0.86|||||||ANCOVA|Main Effects Results only for No Exercise vs Exercise||||||0.86
71150086|NCT00904033|141793115|OTHER|||||||0.19|||||||ANCOVA|||||||0.19
71150087|NCT00904033|141793116|OTHER|||||||0.49|||||||ANCOVA|||||||0.49
71150088|NCT00904033|141793117|OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
71150089|NCT00904033|141793118|OTHER|||||||0.16|||||||t-test, 2 sided|||||||0.16
71150090|NCT00904033|141793119|OTHER|||||||0.84|||||||t-test, 2 sided|||||||0.84
71150091|NCT00904033|141793120|OTHER|||||||0.38|||||||t-test, 2 sided|||||||0.38
71150092|NCT00904033|141793121|OTHER|||||||0.92|||||||t-test, 2 sided|||||||0.92
71150093|NCT00865566|141793167|OTHER|Score test|Hazard Ratio (HR)|0.73|||<|0.001|TWO_SIDED|95.0|0.63|0.84|||Regression, Cox||HR is vaccine / placebo|Cox proportional hazards model to assess the association between treatment assignment and dropout||0.84|0.63|<0.001
71150094|NCT00865566|141793168|OTHER||Hazard Ratio (HR)|0.77||||0.05|TWO_SIDED|95.0|0.59|1.0||Score test|Regression, Cox||HR is vaccine / placebo|Cox PH model to assess the association between treatment assignment and dropout||1|0.59|0.05
71150095|NCT00865566|141793169|OTHER||Cox Proportional Hazard|0.71|||<|0.001|TWO_SIDED|95.0|0.6|0.84||Score test|Regression, Cox||HR is vaccine / placebo|Assess the association between treatment assignment and dropout||0.84|0.60|<0.001
71150096|NCT00865566|141793170|OTHER||Hazard Ratio (HR)|1.02||||0.903|TWO_SIDED|95.0|0.73|1.42||Score test|Regression, Cox|Adjusted for age, behavioral risk score, square of behavioral risk score, race, and BMI|HR is vaccine / placebo|||1.42|0.73|0.903
71150097|NCT00865566|141793171|OTHER||Hazard Ratio (HR)|1.06||||0.783|TWO_SIDED|95.0|0.71|1.58||Adjusted for ave, behavioral risk score, square of behavioral risk score, and BMI|Regression, Cox|Score test|HR is vaccine / placebo|||1.58|0.71|0.783
71150098|NCT01244893|141793189|NON_INFERIORITY_OR_EQUIVALENCE|This study uses -0.05 LogMAR as the non-inferiority margin.|Mean Difference (Final Values)|0.005|STANDARD_ERROR_OF_MEAN|0.003|||TWO_SIDED|95.0|-0.00092|0.01045|||Mixed Models Analysis||The mean difference is calculated as the test lens - control lens.|"Ho: after time period (6-8 days of lens wear), the test lens - control lens will be greater than or equal to the non-inferiority margin specified .~Ha: after time period, test-control will be less than the margin specified concluding that the test lens will be inferior to control lens in terms of LogMAR scale"||0.01045|-0.00092|
71150099|NCT00357552|141793193|NON_INFERIORITY_OR_EQUIVALENCE|Success of the strategy is assessed according to whether the lower bound of the exact 90% confidence interval of this proportion is greater than 65%.|proportion|87.0|||||TWO_SIDED|90.0|81.0|92.0|||confidence interval|Success was determined by whether the lower bound of the 90% exact confidence interval was greater than 65%.|exact confidence interval|The null hypothesis was that LPV/r monotherapy provides at least a 65% short-term virologic response. The target sample size was 120 subjects. Assuming an underlying true 24 week success rate of 76%, this sample size was chosen in order to provide at least 90% power to show that the true 24 week virologic success rate of LPV/r monotherapy in this population is greater than 65%.||92|81|
71150100|NCT03584789|141793231|SUPERIORITY||Odds Ratio (OR)|1.29||||0.08|TWO_SIDED|97.5|0.93|1.8|||Mixed Models Analysis|||||1.80|.93|.08
71150101|NCT03584789|141793231|SUPERIORITY||Odds Ratio (OR)|1.24||||0.18|TWO_SIDED|97.5|0.86|1.79|||Mixed Models Analysis|||||1.79|.86|.18
71150102|NCT03584789|141793232|SUPERIORITY||Odds Ratio (OR)|1.37||||0.71|TWO_SIDED|97.5|0.2|9.44|||Mixed Models Analysis|||||9.44|.20|.71
71150103|NCT03584789|141793232|SUPERIORITY||Odds Ratio (OR)|1.53||||0.62|TWO_SIDED|97.5|0.21|11.0|||Mixed Models Analysis|||||11.00|.21|.62
71150104|NCT03584789|141793233|SUPERIORITY||Median Difference (Net)|-0.07||||0.38|TWO_SIDED|95.0|-0.26|0.12|||Mixed Models Analysis|||||.12|-0.26|.38
71150105|NCT03584789|141793233|SUPERIORITY||Median Difference (Net)|-0.03||||0.7|TWO_SIDED|95.0|-0.24|0.17|||Mixed Models Analysis|||||.17|-0.24|.70
71150106|NCT03584789|141793234|SUPERIORITY||Mean Difference (Net)|-0.14||||0.65|TWO_SIDED|95.0|-0.79|0.5|||Mixed Models Analysis|||||.50|-0.79|.65
71150107|NCT03584789|141793234|SUPERIORITY||Mean Difference (Net)|-0.29||||0.41|TWO_SIDED|95.0|-0.99|0.41|||Mixed Models Analysis|||||.41|-0.99|.41
71150108|NCT00836693|141793297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|95.0|2.2|5.5||p-value is for Week 12 Change. The null hypothesis concerning tadalafil versus placebo was to be rejected if, and only if, the three primary hypotheses (H01, H02, and H03) were all rejected therefore no adjustments for multiple comparisons were made.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||5.5|2.2|<0.001
70875760|NCT00589914|141235352|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 5 points in the change in PANSS total score i.e., lower limit of the 95% CI for difference between groups (RISPERDAL CONSTA minus paliperidone palmitate) had to be greater than -5 to demonstrate non-inferiority.|Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|95.0|-1.62|2.38||No p-value to report.|ANCOVA|ANCOVA model with factors treatment, country and baseline score. Weighted approach used to account for interim analysis for sample size re-estimation.||Null hypothesis: Difference between groups (RISPERDAL CONSTA minus paliperidone palmitate) for the mean change from baseline to endpoint in PANSS total score (LOCF) was less than or equal to -5 (prespecified non-inferiority margin). Sample size: SD of 20 for the change in PANSS total score, a true difference between treatment groups of 0.1 in favor of RISPERDAL CONSTA, 2-sided significance level of 5%, and 80% power. A sample size reestimation was performed when 60% of the data was available.||2.38|-1.62|
70875761|NCT00589914|141235353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|95.0|-0.07|0.17||No P-values reported.|ANCOVA|||The change from baseline was analyzed using an ANCOVA model with factors for treatment and country and baseline score as a covariate.||0.17|-0.07|
70875762|NCT00589914|141235354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|95.0|-1.22|1.69||No P-values reported.|ANCOVA|||The change from baseline was analyzed using an ANCOVA model with factors for treatment and country and baseline score as a covariate.||1.69|-1.22|
70875763|NCT01067456|141235361|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.57||||0.79|TWO_SIDED||||||t-test, 2 sided|||||||0.79
70875764|NCT01737944|141235367|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence of Methotrexate following Treatment A - SC injection with the Vibex MTX device and Treatment B - SC injection without the device was established if the 90% CI for the geometric LS Mean ratios of AUC(0-inf)/Dose were within the range of 80% to 125%.|Test / Reference Ratio|96.24|||||TWO_SIDED|90.0|92.33|100.31||||||||100.31|92.33|
70875765|NCT01737944|141235367|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence of Methotrexate following Treatment A-SC injection with the Vibex MTX device and Treatment C-IM injection was established if the 90% CI for the geometric LS Mean ratios of AUC(0-inf)/Dose were within the range of 80% to 125%.|Test / Reference Ratio|101.28|||||TWO_SIDED|90.0|97.17|105.56||||||||105.56|97.17|
70875766|NCT01737944|141235368|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence of Methotrexate following Treatment A-SC injection with the Vibex MTX device and Treatment B-SC injection was established if the 90% CI for the geometric LS Mean ratios of AUC(0-24)/Dose were within the range of 80% to 125%.|Test / Reference Ratio|96.22|||||TWO_SIDED|90.0|92.32|100.28||||||||100.28|92.32|
70956112|NCT01859988|141415708|SUPERIORITY_OR_OTHER||LS mean difference|-26.8|STANDARD_ERROR_OF_MEAN|6.65|<|0.0001|TWO_SIDED|95.0|-39.8|-13.7||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 100 mg q4w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-13.7|-39.8|<0.0001
70956113|NCT03484273|141415748|SUPERIORITY||||||<|0.001|||||||ANOVA|Repeated Measures ANOVA||Repeated Measured ANOVA was used to compare the 4 compression garment configurations.||||<0.001
70875767|NCT01737944|141235368|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence of Methotrexate following Treatment A-SC injection with the Vibex MTX device and Treatment C-IM injection was established if the 90% CI for the geometric LS Mean ratios of AUC(0-24)/Dose were within the range of 80% to 125%.|Test / Reference Ratio|101.14|||||TWO_SIDED|90.0|97.06|105.4||||||||105.40|97.06|
70875768|NCT01737944|141235369|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence of Methotrexate following Treatment A-SC injection with the Vibex MTX device and Treatment B-SC injection without the device was established if the 90% CI for the geometric LS Mean ratios of Cmax/Dose were within the range of 80% to 125%.|Test / Reference Ratio|96.76|||||TWO_SIDED|90.0|87.93|106.47||||||||106.47|87.93|
70875769|NCT01737944|141235369|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence of Methotrexate following Treatment A-SC injection with the Vibex MTX device and Treatment C-IM injection was established if the 90% CI for the geometric LS Mean ratios of Cmax/Dose were within the range of 80% to 125%.|Test / Reference Ratio|89.79|||||TWO_SIDED|90.0|81.61|98.78||||||||98.78|81.61|
70875770|NCT00799487|141235370|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-27.3|||<|0.0001|TWO_SIDED|95.0|-34.4|-20.2||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis||Placebo minus Concerta|||-20.2|-34.4|<0.0001
70875771|NCT00799487|141235371|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.0|||<|0.0001|TWO_SIDED|95.0|-35.1|-20.8||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis||Placebo minus Concerta|||-20.8|-35.1|<0.0001
70875772|NCT00799487|141235372|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.0|||<|0.0001|TWO_SIDED|95.0|3.4|6.6||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis||Placebo minus Concerta|||6.6|3.4|<0.0001
70956114|NCT03484273|141415749|SUPERIORITY||||||<|0.001|||||||Repeated Measures ANOVA|||||||<0.001
70956115|NCT03484273|141415750|SUPERIORITY||||||<|0.001|||||||Repeated Measures ANOVA|||||||<0.001
70875773|NCT00799487|141235373|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.5|||<|0.0001|TWO_SIDED|95.0|3.2|5.8||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis||Placebo minus Concerta|||5.8|3.2|<0.0001
70956116|NCT03484273|141415751|SUPERIORITY|||||||0.01|||||||Repeated Measures ANOVA|||||||0.01
70956117|NCT03484273|141415752|SUPERIORITY||||||<|0.001|||||||Repeated Measures ANOVA|||||||<0.001
70956118|NCT03484273|141415753|SUPERIORITY|||||||0.001|||||||Repeated Measures ANOVA|||||||0.001
70956119|NCT03484273|141415754|SUPERIORITY|||||||0.04|||||||Repeated Measures ANOVA|||||||0.04
70956120|NCT02081417|141415756|NON_INFERIORITY|Based on the PCL-C if the interventions fell within 2.5 points of each other|Mean Difference (Net)|0.18||||0.01|TWO_SIDED|95.0|-3.4|3.8|||Mixed Models Analysis|||||3.8|-3.4|0.01
70956121|NCT03097484|141415762|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
70956122|NCT03097484|141415763|SUPERIORITY|||||||0.05||||||0.05 is the calculated p-value (not the threshold for statistical significance)|t-test, 2 sided|||||||0.05
70875774|NCT00799487|141235374|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|9.5|||<|0.0001|TWO_SIDED|95.0|6.9|12.0||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis||Placebo minus Concerta|||12.0|6.9|<0.0001
70875775|NCT00799487|141235375|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.51|||<|0.0001|TWO_SIDED|95.0|-4.27|-2.74||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-2.74|-4.27|<0.0001
70875776|NCT00799487|141235376|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-17.58|||<|0.0001|TWO_SIDED|95.0|-23.72|-11.45||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-11.45|-23.72|<0.0001
70875777|NCT00799487|141235377|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-30.33|||<|0.0001|TWO_SIDED|95.0|-39.29|-21.37||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-21.37|-39.29|<0.0001
70875778|NCT00799487|141235378|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.13||||0.0297|TWO_SIDED|95.0|-2.15|-0.12||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-0.12|-2.15|0.0297
70875779|NCT00799487|141235379|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84||||0.0955|TWO_SIDED|95.0|-1.84|0.15||P-values were determined by using a general linear mixed model. Finger Windows Forwards was the first non-significant p-value in the gatekeeper sequence.|Mixed Models Analysis|Testing of additional endpoints in the sequence was still performed without any unqualified statements about the individual statistical significance.|Placebo minus Concerta|||0.15|-1.84|0.0955
70875780|NCT00799487|141235380|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-14.37||||0.0002|TWO_SIDED|95.0|-21.52|-7.23||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-7.23|-21.52|0.0002
70875781|NCT00799487|141235381|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26||||0.2335|TWO_SIDED|95.0|-0.7|0.17||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.17|-0.70|0.2335
70875782|NCT00799487|141235382|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.51||||0.2321|TWO_SIDED|95.0|-6.67|1.65||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||1.65|-6.67|0.2321
70875783|NCT00799487|141235383|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.52||||0.0015|TWO_SIDED|95.0|-5.64|-1.4||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-1.40|-5.64|0.0015
70875784|NCT00799487|141235384|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.38||||0.0101|TWO_SIDED|95.0|-9.43|-1.33||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-1.33|-9.43|0.0101
70875785|NCT00799487|141235385|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09||||0.6642|TWO_SIDED|95.0|-0.53|0.34||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.34|-0.53|0.6642
70875786|NCT00799487|141235386|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-35.3||||0.004|TWO_SIDED|95.0|-58.89|-11.71||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-11.71|-58.89|0.0040
70875787|NCT00799487|141235387|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08||||0.0012|TWO_SIDED|95.0|-0.14|-0.03||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-0.03|-0.14|0.0012
70875788|NCT00799487|141235388|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07||||0.0051|TWO_SIDED|95.0|-0.12|-0.02||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-0.02|-0.12|0.0051
70875789|NCT00799487|141235389|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05||||0.1768|TWO_SIDED|95.0|-0.13|0.02||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.02|-0.13|0.1768
70875790|NCT00799487|141235390|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02||||0.4245|TWO_SIDED|95.0|-0.09|0.04||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.04|-0.09|0.4245
70875791|NCT00799487|141235391|SUPERIORITY_OR_OTHER_LEGACY||LS Mean DIfference|0.0||||0.9729|TWO_SIDED|95.0|-0.09|0.09||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.09|-0.09|0.9729
70875792|NCT00799487|141235392|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04||||0.3486|TWO_SIDED|95.0|-0.12|0.04||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.04|-0.12|0.3486
70875793|NCT00799487|141235393|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03||||0.1466|TWO_SIDED|95.0|-0.07|0.01||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.01|-0.07|0.1466
70875794|NCT00799487|141235394|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03||||0.1368|TWO_SIDED|95.0|-0.01|0.08||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.08|-0.01|0.1368
70875795|NCT02959944|141235401|SUPERIORITY||Difference in Rates|0.043||||0.5384|TWO_SIDED|95.0|-0.094|0.181||P-value is computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval is computed using normal approximation.|||0.181|-0.094|0.5384
70875796|NCT02959944|141235402|SUPERIORITY||Difference in Rates|0.043||||0.5384|TWO_SIDED|95.0|-0.094|0.181||P-value is computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval is computed using normal approximation.|||0.181|-0.094|0.5384
70956123|NCT00294515|141415795|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4|||<=|0.0002|TWO_SIDED|95.0|0.25|0.66|||Cochran-Mantel-Haenszel|Stratified by Center Pools||||0.66|0.25|<=0.0002
70875797|NCT02959944|141235403|SUPERIORITY|||||||0.324||||||Gray's chi-square test (p-value) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy.|Chi-squared|||||||0.324
70875798|NCT02959944|141235404|SUPERIORITY|||||||0.281||||||Gray's chi-square test (p-value) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy.|Chi-squared|||||||0.281
70875799|NCT02959944|141235405|SUPERIORITY|||||||0.275||||||Gray's chi-square test (p-value) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy.|Chi-squared|||||||0.275
70956124|NCT00294515|141415796|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.2|||<|0.0001||95.0|0.11|0.37|||Cochran-Mantel-Haenszel|Stratified by Center Pools||||0.37|0.11|<0.0001
70956125|NCT00294515|141415797|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.37||||0.0001||95.0|0.22|0.6|||Cochran-Mantel-Haenszel|Stratified by Center Pools||||0.60|0.22|0.0001
70956126|NCT00294515|141415798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.0126||95.0|0.35|0.88|||Cochran-Mantel-Haenszel|Stratified by Center Pools||||0.88|0.35|0.0126
70956127|NCT00294515|141415799|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55||||0.01||95.0|0.34|0.86|||Cochran-Mantel-Haenszel|Stratified by Center Pools||||0.86|0.34|0.0100
71150109|NCT00836693|141793298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7|STANDARD_ERROR_OF_MEAN|3.35|<|0.001|TWO_SIDED|95.0|5.1|18.3||p-value is for Week 12 Change. The null hypothesis concerning tadalafil versus placebo was to be rejected if, and only if, the three primary hypotheses (H01, H02, and H03) were all rejected therefore no adjustments for multiple comparisons were made.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||18.3|5.1|<0.001
71150110|NCT00836693|141793299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.0|STANDARD_ERROR_OF_MEAN|4.6|<|0.001|TWO_SIDED|95.0|8.9|27.0||p-value is for Week 12 Change. The null hypothesis concerning tadalafil versus placebo was to be rejected if, and only if, the three primary hypotheses (H01, H02, and H03) were all rejected therefore no adjustments for multiple comparisons were made.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||27.0|8.9|<0.001
71150111|NCT00836693|141793303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.2|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|9.5|22.8||P-value is for Week 12 change. For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The change from baseline to endpoint in morning erection percentages was analyzed with an ANCOVA model including terms for baseline value, treatment group, country, age and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||22.8|9.5|<0.001
71150112|NCT00836693|141793304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.0|STANDARD_ERROR_OF_MEAN|3.11|>|0.001|TWO_SIDED|95.0|13.9|26.1||p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANOVA|||The models included terms for baseline value of the efficacy variable,treatment group,country, and the baseline-by-treatment-group interaction.In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||26.1|13.9|>0.001
71150113|NCT00836693|141793305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7|STANDARD_ERROR_OF_MEAN|3.17|<|0.001|TWO_SIDED|95.0|5.5|18.0||p-value is for Total (Change). For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||18.0|5.5|<0.001
71150114|NCT00836693|141793305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.2|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|6.6|19.8||p-value is for Sexual Relationship Domain(Change).For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||19.8|6.6|<0.001
70956128|NCT00371683|141415834|NON_INFERIORITY_OR_EQUIVALENCE|Two criteria were to be met to demonstrate non-inferiority: the upper bound of the 95% confidence interval (CI) for the Relative Risk should be \< 1.25, and the upper bound of the 95% CI for the risk difference should be \< 5.6%.|Risk Ratio (RR)|1.02||||0.0635|TWO_SIDED|95.0|0.78|1.32||If p-value is less than 0.025, it is statistically significant.|t-test, 1 sided|||||1.32|0.78|0.0635
70956129|NCT00371683|141415834|NON_INFERIORITY_OR_EQUIVALENCE|Two criteria were to be met to demonstrate non-inferiority: the upper bound of the 95% CI for the relative risk should be \< 1.25, and the upper bound of the 95% CI for the risk difference should be \< 5.6%.|Risk Difference (RD)|0.11|||<|0.0001|TWO_SIDED|95.0|-2.22|2.44||If p-value is less than 0.025, it is statistically significant.|t-test, 1 sided|||||2.44|-2.22|<0.0001
70956130|NCT00371683|141415835|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.25|||||TWO_SIDED|95.0|0.7|2.23|||||If the upper bound of the two-sided 95% CI for the Relative Risk was \< 1 then superiority for the key secondary efficacy endpoint was demonstrated.|||2.23|0.70|
70956131|NCT00371683|141415835|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.36|||||TWO_SIDED|95.0|-0.68|1.4||||||||1.40|-0.68|
70956132|NCT00371683|141415835|SUPERIORITY_OR_OTHER|||||||0.7779|TWO_SIDED||||||t-test, 1 sided|||||||0.7779
70956133|NCT00371683|141415836|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.04|||||TWO_SIDED|95.0|0.8|1.35||||||||1.35|0.80|
70956134|NCT00371683|141415836|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.28|||||TWO_SIDED|95.0|-2.04|2.59||||||||2.59|-2.04|
71150115|NCT00836693|141793305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.9|STANDARD_ERROR_OF_MEAN|3.34||0.0034|TWO_SIDED|95.0|3.3|16.5||p-value is for Confidence Domain (Change).For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||16.5|3.3|0.0034
71150116|NCT00836693|141793305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|3.52||0.002|TWO_SIDED|95.0|4.1|17.9||p-value is for Self-Esteem Domain (Change).For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||17.9|4.1|0.0020
71150117|NCT00836693|141793305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.5|STANDARD_ERROR_OF_MEAN|4.07||0.0653|TWO_SIDED|95.0|-0.5|15.6||p-value is for Overall Relationship Domain(Change).For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||15.6|-0.5|0.0653
70875800|NCT02959944|141235406|SUPERIORITY|||||||0.216||||||Gray's chi-square test (p-value) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy.|Chi-squared|||||||0.216
71150118|NCT00836693|141793306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|0.7|1.9||p-value is for Week 12 Change.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||1.9|0.7|<0.001
71150119|NCT00836693|141793307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.25||0.0089|TWO_SIDED|95.0|0.2|1.1||p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||1.1|0.2|0.0089
71150120|NCT00836693|141793308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|0.37||0.0461|TWO_SIDED|95.0|0.0|1.5||p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||1.5|0.0|0.0461
71150121|NCT00836693|141793309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|0.7|1.9||p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||1.9|0.7|<0.001
71150122|NCT00836693|141793310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3|STANDARD_ERROR_OF_MEAN|2.22||0.0047|TWO_SIDED|95.0|2.0|10.7||p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Baseline = Visit 2; Endpoint = the last non-missing post-baseline value until Visit 5; Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (that is, if p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on the type 3 sums of squares.||10.7|2.0|0.0047
71150123|NCT00836693|141793311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.5|STANDARD_ERROR_OF_MEAN|4.99|<|0.001|TWO_SIDED|95.0|14.6|34.3||p-value is for Week 12 Change.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Baseline = Visit 2; Endpoint = the last non-missing post-baseline value until Visit 5; Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (that is, if p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on the type 3 sums of squares.||34.3|14.6|<0.001
71150124|NCT00836693|141793312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.5|STANDARD_ERROR_OF_MEAN|4.96|<|0.001|TWO_SIDED|95.0|13.7|33.2||p-value is for Week 12 Change.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Baseline = Visit 2; Endpoint = the last non-missing post-baseline value until Visit 5; Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (that is, if p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on the type 3 sums of squares.||33.2|13.7|<0.001
71150125|NCT00836693|141793313|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for Global Assessment Questions GAQ1. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|Wilcoxon (Mann-Whitney)|||Wilcoxon's rank sum test was used to compare responses to GAQs between treatment groups.||||<0.0001
71150126|NCT00836693|141793314|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for Global Assessment Question GAQ2.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|Wilcoxon (Mann-Whitney)|||Wilcoxon's rank sum test was used to compare responses to GAQs between treatment groups.||||<0.0001
71150127|NCT01750229|141793329|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|Variables included in the Mixed Model were: baseline VAS back pain score, treatment group, and period.||||||0.002
71150128|NCT03771664|141793370|SUPERIORITY||Least Square (LS) Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|2.23||0.1537|TWO_SIDED|95.0|-1.2|7.7||Average change from baseline in SE was analyzed by analysis of covariance (ANCOVA) with explanatory (treatment, baseline antidepressant use, baseline SE) and response variables \[change from baseline in sleep efficiency at Day 14 (EODBT)\].|ANCOVA|||||7.7|-1.2|0.1537
71150129|NCT03771664|141793371|SUPERIORITY||LS Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|8.07||0.1126|TWO_SIDED|95.0|-29.0|3.1||Change from BL in overall WASO was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from baseline (BL) in overall WASO||3.1|-29.0|0.1126
71150130|NCT03771664|141793371|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.63||0.9819|TWO_SIDED|95.0|-3.3|3.2||Change from BL in WASO was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in WASO in quarter 1||3.2|-3.3|0.9819
71150131|NCT03771664|141793371|SUPERIORITY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|3.19||0.1838|TWO_SIDED|95.0|-10.6|2.1||Change from BL in WASO was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in WASO in quarter 2||2.1|-10.6|0.1838
71150132|NCT03771664|141793371|SUPERIORITY||LS Mean Difference|-7.1|STANDARD_ERROR_OF_MEAN|3.97||0.0797|TWO_SIDED|95.0|-15.0|0.9||Change from BL in WASO was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, baseline PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in WASO in quarter 3||0.9|-15.0|0.0797
71150133|NCT03771664|141793371|SUPERIORITY||LS Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|4.24||0.1559|TWO_SIDED|95.0|-14.5|2.4||Change from BL in WASO was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, baseline PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in WASO in quarter 4||2.4|-14.5|0.1559
71150134|NCT03771664|141793372|SUPERIORITY||LS Mean Difference|15.8|STANDARD_ERROR_OF_MEAN|10.67||0.1441|TWO_SIDED|95.0|-5.5|37.0||Change from BL in TST was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in overall TST||37.0|-5.5|0.1441
71150135|NCT03771664|141793372|SUPERIORITY||LS Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|5.47||0.3951|TWO_SIDED|95.0|-6.2|15.6||Change from BL in TST was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in TST in quarter 1||15.6|-6.2|0.3951
71150136|NCT03771664|141793372|SUPERIORITY||LS Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|4.16||0.3705|TWO_SIDED|95.0|-4.5|12.0||Change from BL in TST was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BLPSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in TST in quarter 2||12.0|-4.5|0.3705
71150137|NCT03771664|141793372|SUPERIORITY||LS Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|4.04||0.1412|TWO_SIDED|95.0|-2.0|14.0||Change from BL in TST was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in TST in quarter 3||14.0|-2.0|0.1412
71150138|NCT03771664|141793372|SUPERIORITY||LS Mean Difference|6.5|STANDARD_ERROR_OF_MEAN|4.24||0.1298|TWO_SIDED|95.0|-2.0|15.0||Change from BL in TST was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in TST in quarter 4||15.0|-2.0|0.1298
71150139|NCT03771664|141793373|SUPERIORITY||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|7.87||0.7526|TWO_SIDED|95.0|-18.2|13.2||Change from BL in LPS was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||||13.2|-18.2|0.7526
71150140|NCT03771664|141793374|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.83||0.6769|TWO_SIDED|95.0|-2.0|1.3||Change from BL in NAW was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||||1.3|-2.0|0.6769
71150141|NCT03771664|141793375|SUPERIORITY||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.7||0.0824|TWO_SIDED|95.0|-6.4|0.4||Change from BL in MDA was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in mean duration of awakenings (MDA) in total||0.4|-6.4|0.0824
71150142|NCT03771664|141793375|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.07||0.4269|TWO_SIDED|95.0|-3.0|1.3||Change from BL in MDA was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in MDA in quarter 1||1.3|-3.0|0.4269
71150143|NCT03771664|141793375|SUPERIORITY|Change from BL in MDA was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|LS Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|3.02||0.2482|TWO_SIDED|95.0|-9.5|2.5|||ANCOVA|||Change from BL in MDA in quarter 2||2.5|-9.5|0.2482
70875801|NCT02959944|141235407|SUPERIORITY||Difference in Rates|-0.067||||0.351|TWO_SIDED|95.0|-0.208|0.074||P-value was computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval is computed using normal approximation.|||0.074|-0.208|0.3510
70875802|NCT02959944|141235408|SUPERIORITY||Difference in Rates|-0.067||||0.351|TWO_SIDED|95.0|-0.208|0.074||P-value was computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval is computed using normal approximation.|||0.074|-0.208|0.3510
70875803|NCT02959944|141235409|SUPERIORITY||Difference in Rates|0.124||||0.0659|TWO_SIDED|95.0|-0.007|0.256||P-value is computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval is computed using normal approximation.|||0.256|-0.007|0.0659
70875804|NCT02959944|141235410|SUPERIORITY||Difference in Rates|0.125||||0.0708|TWO_SIDED|95.0|-0.01|0.261||P-value is computed using non-stratified Chi-Square test.|Chi-squared|||||0.261|-0.010|0.0708
71150144|NCT03771664|141793375|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|3.34||0.3076|TWO_SIDED|95.0|-10.1|3.2||Change from BL in MDA was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in MDA in quarter 3||3.2|-10.1|0.3076
70875805|NCT02959944|141235411|SUPERIORITY||Difference in Rates|-0.059||||0.4064|TWO_SIDED|95.0|-0.199|0.08||P-value was computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval was computed using normal approximation.|||0.080|-0.199|0.4064
70875806|NCT02959944|141235412|SUPERIORITY||Difference in Rates|-0.049||||0.4955|TWO_SIDED|95.0|-0.188|0.091||P-value was computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval was computed using normal approximation.|||0.091|-0.188|0.4955
70875807|NCT02959944|141235413|SUPERIORITY||Hazard Ratio (HR)|0.994|||||TWO_SIDED|95.0|0.507|1.949|||||Hazard ratio is estimated using unstratified Cox regression model with treatment as the only covariate.|||1.949|0.507|
70875808|NCT02959944|141235414|SUPERIORITY||Hazard Ratio (HR)|1.061|||||TWO_SIDED|95.0|0.591|1.904|||||Hazard ratio is estimated using unstratified Cox regression model with treatment as the only covariate.|||1.904|0.591|
70875809|NCT02959944|141235415|SUPERIORITY||Hazard Ratio (HR)|0.697||||0.101|TWO_SIDED|95.0|0.451|1.076|||Regression, Cox|||||1.076|0.451|0.1010
70875810|NCT02959944|141235416|SUPERIORITY||Hazard Ratio (HR)|0.717||||0.1004|TWO_SIDED|95.0|0.482|1.068|||Regression, Cox|||||1.068|0.482|0.1004
70875811|NCT03070782|141235463|SUPERIORITY||Mean Difference in % CFB|-31.0||||0.0032|TWO_SIDED|95.0|-46.0|-12.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|||-12|-46|0.0032
70875812|NCT03070782|141235463|SUPERIORITY||Mean Difference in % CFB|-54.0|||<|0.0001|TWO_SIDED|95.0|-64.0|-41.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-41|-64|<.0001
70875813|NCT03070782|141235463|SUPERIORITY||Mean Difference in % CFB|-70.0|||<|0.0001|TWO_SIDED|95.0|-77.0|-62.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-62|-77|<.0001
70875814|NCT03070782|141235463|SUPERIORITY||Mean Difference in % CFB|-56.0|||<|0.0001|TWO_SIDED|95.0|-65.0|-43.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-43|-65|<.0001
70875815|NCT03070782|141235463|SUPERIORITY||Mean Difference in % CFB|-78.0|||<|0.0001|TWO_SIDED|95.0|-83.0|-72.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-72|-83|<.0001
71150145|NCT03771664|141793375|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.68||0.4491|TWO_SIDED|95.0|-1.9|0.8||Change from BL in MDA was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in MDA in quarter 4||0.8|-1.9|0.4491
70956135|NCT00371683|141415836|SUPERIORITY_OR_OTHER|||||||0.7754|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.7754
70875816|NCT03070782|141235467|SUPERIORITY||Mean Difference in % CFB|-6.0||||0.4407|TWO_SIDED|95.0|-19.0|9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||9|-19|0.4407
70875817|NCT03070782|141235467|SUPERIORITY||Mean Difference in % CFB|-25.0|||<|0.0001|TWO_SIDED|95.0|-35.0|-13.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-13|-35|<.0001
70875818|NCT03070782|141235467|SUPERIORITY||Mean Difference in % CFB|-14.0||||0.0368|TWO_SIDED|95.0|-26.0|-1.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-1|-26|0.0368
70875819|NCT03070782|141235467|SUPERIORITY||Mean Difference in % CFB|-16.0||||0.0216|TWO_SIDED|95.0|-28.0|-3.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-3|-28|0.0216
70875820|NCT03070782|141235467|SUPERIORITY||Mean Difference in % CFB|-22.0||||0.0012|TWO_SIDED|95.0|-33.0|-9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-9|-33|0.0012
70875821|NCT03070782|141235468|SUPERIORITY||Odds Ratio (OR)|4.98||||0.0286|TWO_SIDED|95.0|1.2|21.0|||Regression, Logistic|||||21.0|1.2|0.0286
70875822|NCT03070782|141235468|SUPERIORITY||Odds Ratio (OR)|31.07|||<|0.0001|TWO_SIDED|95.0|7.3|131.4|||Regression, Logistic|||||131.4|7.3|<.0001
70875823|NCT03070782|141235468|SUPERIORITY||Odds Ratio (OR)|122.81|||<|0.0001|TWO_SIDED|95.0|24.0|627.4|||Regression, Logistic|||||627.4|24.0|<.0001
70875824|NCT03070782|141235468|SUPERIORITY||Odds Ratio (OR)|43.78|||<|0.0001|TWO_SIDED|95.0|9.8|195.0|||Regression, Logistic|||||195.0|9.8|<.0001
70875825|NCT03070782|141235468|SUPERIORITY||Odds Ratio (OR)|1124.56|||<|0.0001|TWO_SIDED|95.0|109.3|11571.0|||Regression, Logistic|||||11571|109.3|<.0001
70875826|NCT03070782|141235469|SUPERIORITY||Odds Ratio (OR)|7.34||||0.2007|TWO_SIDED|95.0|0.3|155.3|||Regression, Logistic|||||155.3|0.3|0.2007
70875827|NCT03070782|141235469|SUPERIORITY||Odds Ratio (OR)|27.92||||0.0258|TWO_SIDED|95.0|1.5|521.5|||Regression, Logistic|||||521.5|1.5|0.0258
70875828|NCT03070782|141235469|SUPERIORITY||Odds Ratio (OR)|113.92||||0.0014|TWO_SIDED|95.0|6.2|2098.5|||Regression, Logistic|||||2098.5|6.2|0.0014
70875829|NCT03070782|141235469|SUPERIORITY||Odds Ratio (OR)|59.85||||0.0063|TWO_SIDED|95.0|3.2|1128.0|||Regression, Logistic|||||1128.0|3.2|0.0063
70956136|NCT00371683|141415837|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.41|||||TWO_SIDED|95.0|0.77|2.6||||||||2.60|0.77|
70956137|NCT00371683|141415837|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.53|||||TWO_SIDED|95.0|-0.47|1.52||||||||1.52|-0.47|
70956138|NCT00371683|141415837|SUPERIORITY_OR_OTHER|||||||0.2626|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.2626
71150146|NCT03771664|141793376|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|2.47||0.8724|TWO_SIDED|95.0|-4.5|5.3||Change from BL in DS N1 sleep was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in duration of stage (DS) N1 sleep||5.3|-4.5|0.8724
71150147|NCT03771664|141793376|SUPERIORITY||LS Mean Difference|18.6|STANDARD_ERROR_OF_MEAN|8.08||0.0238|TWO_SIDED|95.0|2.5|34.7||Change from BL in DS N2 sleep was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in DS N2 sleep||34.7|2.5|0.0238
70875830|NCT03070782|141235469|SUPERIORITY||Odds Ratio (OR)|347.02|||<|0.0001|TWO_SIDED|95.0|18.3|6597.9|||Regression, Logistic|||||6597.9|18.3|<.0001
70875831|NCT03070782|141235470|SUPERIORITY||Mean Difference in % CFB|-4.0||||0.4022|TWO_SIDED|95.0|-12.0|5.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||5|-12|0.4022
70956139|NCT00371683|141415838|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.63|1.87||||||||1.87|0.63|
71150148|NCT03771664|141793376|SUPERIORITY||LS Mean Difference|4.9|STANDARD_ERROR_OF_MEAN|5.62||0.3863|TWO_SIDED|95.0|-6.3|16.1||Change from BL in DS N3 sleep was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in DS N3 sleep||16.1|-6.3|0.3863
71150149|NCT03771664|141793376|SUPERIORITY||LS Mean Difference|-10.2|STANDARD_ERROR_OF_MEAN|4.69||0.032|TWO_SIDED|95.0|-19.6|-0.9||Change from BL in REM sleep duration was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14(EODBT)\].|ANCOVA|||Change from BL in duration of REM sleep||-0.9|-19.6|0.0320
71150150|NCT03771664|141793377|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.8||0.9524|TWO_SIDED|95.0|-1.7|1.6||Change from BL in PS N1 sleep time was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score;Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in percentage of stage (PS) N1 sleep time||1.6|-1.7|0.9524
71150151|NCT03771664|141793377|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.55||0.093|TWO_SIDED|95.0|-0.5|5.7||Change from BL in PS N2 sleep time was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in PS N2 sleep time||5.7|-0.5|0.0930
71150152|NCT03771664|141793377|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.52||0.4427|TWO_SIDED|95.0|-1.9|4.2||Change from BL in PS N3 sleep time was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in PS N3 sleep time||4.2|-1.9|0.4427
71150153|NCT03771664|141793377|SUPERIORITY||LS Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|1.06||0.0006|TWO_SIDED|95.0|-5.9|-1.7||Change from BL in % of REM sleep duration was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||Change from BL in percentage (%) of REM sleep time||-1.7|-5.9|0.0006
71150154|NCT03771664|141793378|SUPERIORITY||LS Mean Difference|33.7|STANDARD_ERROR_OF_MEAN|12.42||0.0083|TWO_SIDED|95.0|8.9|58.4||Change from BL in latency to first REM period was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||Change from BL in latency to the first REM period||58.4|8.9|0.0083
71150155|NCT03771664|141793378|SUPERIORITY||LS Mean Difference|43.2|STANDARD_ERROR_OF_MEAN|10.95||0.0002|TWO_SIDED|95.0|21.3|65.0||Change from BL in latency to second REM period was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||Change from BL in latency to the second REM period||65.0|21.3|0.0002
71150156|NCT03771664|141793378|SUPERIORITY||LS Mean Difference|38.2|STANDARD_ERROR_OF_MEAN|10.99||0.0009|TWO_SIDED|95.0|16.2|60.2||Change from BL in latency to third REM period was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||Change from BL in latency to the third REM period||60.2|16.2|0.0009
70875832|NCT03070782|141235470|SUPERIORITY||Mean Difference in % CFB|-16.0|||<|0.0001|TWO_SIDED|95.0|-23.0|-9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-9|-23|<.0001
70875833|NCT03070782|141235470|SUPERIORITY||Mean Difference in % CFB|-9.0||||0.0323|TWO_SIDED|95.0|-17.0|-1.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-1|-17|0.0323
70875834|NCT03070782|141235470|SUPERIORITY||Mean Difference in % CFB|-10.0||||0.0157|TWO_SIDED|95.0|-18.0|-2.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-2|-18|0.0157
71150157|NCT03771664|141793378|SUPERIORITY||LS Mean Difference|26.0|STANDARD_ERROR_OF_MEAN|14.84||0.0899|TWO_SIDED|95.0|-4.3|56.3||Change from BL in latency to fourth REM period was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||Change from BL in latency to the fourth REM period||56.3|-4.3|0.0899
71150158|NCT03771664|141793379|SUPERIORITY||LS Mean Difference|-171.1|STANDARD_ERROR_OF_MEAN|46.06||0.0004|TWO_SIDED|95.0|-262.9|-79.4||Change from BL in REM density was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||||-79.4|-262.9|0.0004
71150159|NCT03771664|141793380|SUPERIORITY||LS Mean Difference|-288.0|STANDARD_ERROR_OF_MEAN|68.81|<|0.0001|TWO_SIDED|95.0|-425.1|-151.0||Change from BL in REMA was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, baseline PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||||-151.0|-425.1|<0.0001
71150160|NCT03771664|141793382|SUPERIORITY||LS Mean Difference|10.4|STANDARD_ERROR_OF_MEAN|14.65||0.4814|TWO_SIDED|95.0|-18.8|39.5||Change from BL in sTST was analyzed by Mixed Model Repeated Measures (MMRM) with treatment baseline antidepressant use, baseline CSD-C value, assessment time point, and time point-by-treatment interaction as fixed effects.|MMRM|||Change from BL in sTST||39.5|-18.8|0.4814
70875835|NCT03070782|141235470|SUPERIORITY||Mean Difference in % CFB|-17.0|||<|0.0001|TWO_SIDED|95.0|-24.0|-9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-9|-24|<.0001
70875836|NCT03070782|141235471|SUPERIORITY||Mean Difference in % CFB|-9.0||||0.4956|TWO_SIDED|95.0|-32.0|21.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||21|-32|0.4956
70875837|NCT03070782|141235471|SUPERIORITY||Mean Difference in % CFB|-36.0||||0.0027|TWO_SIDED|95.0|-52.0|-14.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-14|-52|0.0027
70956140|NCT00371683|141415838|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.11|||||TWO_SIDED|95.0|-0.99|1.21||||||||1.21|-0.99|
70956141|NCT00371683|141415838|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.7700
71150161|NCT03771664|141793382|SUPERIORITY||LS Mean Difference|-10.9|STANDARD_ERROR_OF_MEAN|6.45||0.0964|TWO_SIDED|95.0|-23.7|2.0||Change from BL in sWASO was analyzed by MMRM with treatment baseline antidepressant use, baseline CSD-C value, assessment time point, and time point-by-treatment interaction as fixed effects.|MMRM|||Change from BL in sWASO||2.0|-23.7|0.0964
71150162|NCT03771664|141793382|SUPERIORITY||LS Mean Difference|6.6|STANDARD_ERROR_OF_MEAN|7.32||0.3672|TWO_SIDED|95.0|-7.9|21.2||Change from BL in sSL was analyzed by MMRM with treatment baseline antidepressant use, baseline CSD-C value, assessment time point, and time point-by-treatment interaction as fixed effects.|MMRM|||Change from BL in sSL||21.2|-7.9|0.3672
71150163|NCT03096288|141793409|SUPERIORITY||Mean Difference (Final Values)|22.0||||0.169|TWO_SIDED|95.0|-9.0|52.0|||t-test, 2 sided|||||52|-9|0.169
71150164|NCT03096288|141793409|SUPERIORITY||Median Difference (Final Values)|17.0||||0.236|TWO_SIDED|95.0|-11.0|45.0|||t-test, 2 sided|||||45|-11|0.236
71150165|NCT01411891|141793429|SUPERIORITY||Risk Ratio (RR)|1.5|||||TWO_SIDED|95.0|0.3|8.4||||||||8.4|0.3|
71150166|NCT01411891|141793430|SUPERIORITY||Risk Ratio (RR)|0.8||||0.65|TWO_SIDED|95.0|0.4|1.6|||Regression, Logistic|||||1.6|0.4|0.65
71150167|NCT02004093|141793432|SUPERIORITY_OR_OTHER|||||||0.3967|||||||Log Rank|||||||0.3967
71150168|NCT02004093|141793432|SUPERIORITY_OR_OTHER|||||||0.4552|||||||Wilcoxon (Mann-Whitney)|||||||0.4552
71150169|NCT02004093|141793432|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.3972|TWO_SIDED|80.0|0.92|1.49||p-value resulting from Wald test of null hypothesis that the hazard ratio equals (=) 1|Wald test|||||1.49|0.92|0.3972
71150170|NCT02004093|141793433|SUPERIORITY_OR_OTHER||Difference in Response Rates|6.32||||0.3943|TWO_SIDED|80.0|-3.9|16.6|||Chi-squared|||||16.6|-3.9|0.3943
70956142|NCT00371683|141415839|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.19|||||TWO_SIDED|95.0|0.68|2.11||||||||2.11|0.68|
71150171|NCT02004093|141793433|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36|||||TWO_SIDED|80.0|0.86|2.17|||||approximate 80% confidence interval (CI) for difference of two rates using Hauck-Anderson method|||2.17|0.86|
71150172|NCT02004093|141793434|SUPERIORITY_OR_OTHER|||||||0.3655|||||||Log Rank|||||||0.3655
71150173|NCT02004093|141793434|SUPERIORITY_OR_OTHER|||||||0.1319|||||||Wilcoxon (Mann-Whitney)|||||||0.1319
71150174|NCT02004093|141793434|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22||||0.3679|TWO_SIDED|80.0|0.92|1.61|||Wald test|p-value resulting from Wald test of null hypothesis that the hazard ratio=1||||1.61|0.92|0.3679
71150175|NCT02004093|141793437|SUPERIORITY_OR_OTHER|||||||0.8129|||||||Log Rank|||||||0.8129
71150176|NCT02004093|141793437|SUPERIORITY_OR_OTHER|||||||0.692|||||||Wilcoxon (Mann-Whitney)|||||||0.6920
71150177|NCT02004093|141793437|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.8137|TWO_SIDED|80.0|0.82|1.32|||Wald test|p-value resulting from Wald test of null hypothesis that the hazard ratio=1||||1.32|0.82|0.8137
71150178|NCT02004093|141793440|SUPERIORITY_OR_OTHER|||||||0.5726|||||||Log Rank|||||||0.5726
71150179|NCT02004093|141793440|SUPERIORITY_OR_OTHER|||||||0.3903|||||||Wilcoxon (Mann-Whitney)|||||||0.3903
71150180|NCT02004093|141793440|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.587|TWO_SIDED|80.0|0.87|1.43|||Wald test|p-value resulting from Wald test of null hypothesis that the hazard ratio=1||||1.43|0.87|0.5870
71150181|NCT02004093|141793442|SUPERIORITY_OR_OTHER|||||||0.9261|||||||Log Rank|||||||0.9261
71150182|NCT02004093|141793442|SUPERIORITY_OR_OTHER|||||||0.8591|||||||Wilcoxon (Mann-Whitney)|||||||0.8591
71150183|NCT02004093|141793442|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.9262|TWO_SIDED|80.0|0.74|1.41||p-value resulting from Wald test of null hypothesis that the hazard ratio=1|Wald test|||||1.41|0.74|0.9262
71150184|NCT00414596|141793505|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Mixed Models Analysis|The primary pain end-point was assessed by a mixed effect model with time (visit) and as fixed effects and subject as random effect.||"Hypothesis: Patients with chronic low back pain who undergo spinal decompression with a standardized 6-week regimen consisting of 20 treatments with the spinal decompression system would experience \>50% reduction in their verbal score of pain intensity.~Power Analysis: Mean pain scores at time of enrollment were assumed to equal 6 with potential reduction in pain of 50%. To obtain 80% power at an alpha level of 0.05, sample size was estimated as 20 patients."||||.0001
71150185|NCT02558296|141793517|SUPERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 24 was less than the mean change in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Net)|-0.48|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.39||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the primary endpoint was that the mean change in HbA1c from baseline to Week 24 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.39|-0.56|<0.0001
71150186|NCT02558296|141793518|SUPERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 24 was less than the mean change in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Net)|-0.52|||<|0.0001|TWO_SIDED|95.0|-0.65|-0.4||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories, history of heart failure, treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the secondary endpoint was that the mean change in HbA1c from baseline to Week 24 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.40|-0.65|<0.0001
70956143|NCT00371683|141415839|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.28|||||TWO_SIDED|95.0|-0.78|1.33||||||||1.33|-0.78|
70956144|NCT00371683|141415839|SUPERIORITY_OR_OTHER|||||||0.5443|TWO_SIDED||||||test of equality|For descriptive purposes only, p-values were presented for the test of equality of event rates||||||0.5443
70956145|NCT00371683|141415840|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.2|4.93||||||||4.93|0.20|
70956146|NCT00371683|141415840|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-0.3|0.3||||||||0.30|-0.30|
70875838|NCT03070782|141235471|SUPERIORITY||Mean Difference in % CFB|-54.0|||<|0.0001|TWO_SIDED|95.0|-65.0|-38.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-38|-65|<.0001
70875839|NCT03070782|141235471|SUPERIORITY||Mean Difference in % CFB|-31.0||||0.0114|TWO_SIDED|95.0|-48.0|-8.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-8|-48|0.0114
70875840|NCT03070782|141235471|SUPERIORITY||Mean Difference in % CFB|-62.0|||<|0.0001|TWO_SIDED|95.0|-72.0|-49.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-49|-72|<.0001
70875841|NCT03070782|141235472|SUPERIORITY||Mean Difference in % CFB|-45.0||||0.002|TWO_SIDED|95.0|-62.0|-19.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-19|-62|0.0020
70875842|NCT03070782|141235472|SUPERIORITY||Mean Difference in % CFB|-63.0|||<|0.0001|TWO_SIDED|95.0|-74.0|-46.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-46|-74|<.0001
70875843|NCT03070782|141235472|SUPERIORITY||Mean Difference in % CFB|-82.0|||<|0.0001|TWO_SIDED|95.0|-87.0|-73.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-73|-87|<.0001
70875844|NCT03070782|141235472|SUPERIORITY||Mean Difference in % CFB|-68.0|||<|0.0001|TWO_SIDED|95.0|-78.0|-54.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-54|-78|<.0001
70875845|NCT03070782|141235472|SUPERIORITY||Mean Difference in % CFB|-89.0|||<|0.0001|TWO_SIDED|95.0|-93.0|-84.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-84|-93|<.0001
70875846|NCT00010374|141235492|OTHER|Performance goal of 35%|Exact two-sided binomial test|96.2|||<|0.001|TWO_SIDED|95.0|87.0|99.5|||Exact two-sided binomial test|||||99.5|87.0|<0.001
70956147|NCT00371683|141415840|SUPERIORITY_OR_OTHER|||||||0.9975|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.9975
70875847|NCT04044716|141235527|SUPERIORITY|||||||0.048|||||||ANCOVA|age, joint involved in surgery, sex, baseline pain||||||.048
70956148|NCT00371683|141415841|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.13|||||TWO_SIDED|95.0|-0.05|0.3||||||||0.30|-0.05|
70875848|NCT04044716|141235528|SUPERIORITY|||||||0.29|||||||ANCOVA|adjusted for age, sex, type of surgery (joint), baseline pain||||||0.29
70875849|NCT04044716|141235529|SUPERIORITY|||||||0.64|||||||ANCOVA|adjusted for age, sex, type of surgery (joint), baseline morphine milligram equivalents (MME)||||||0.64
70875850|NCT04044716|141235530|SUPERIORITY|||||||0.86|||||||ANCOVA|adjusted for age, sex, type of surgery (joint), baseline MME, and time in hospital||||||0.86
70875851|NCT04044716|141235531|SUPERIORITY|||||||0.661||||||adjusted for age, type of surgery (joint), and sex|ANCOVA|||||||0.661
70875852|NCT00060008|141235574|SUPERIORITY_OR_OTHER|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
70875853|NCT00824512|141235609|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9133|TWO_SIDED|95.0||||No multiplicity adjustment performed for this study and all statistical tests are two-sided at the 5% significance level.|Non parametric ANCOVA on the rank test|The baseline value was used as a covariate.||||||0.9133
70875854|NCT00071513|141235635|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Mean changes in Short Moods and Feelings measure of depression was the unit of analysis.||||<0.05
70875855|NCT00071513|141235635|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||A secondary hypothesis of the study was that attachment to school and/or perceptions of school supportiveness would mediate the effect of the HSTS intervention on depressive symptoms.||||<0.01
70875856|NCT02260921|141235637|SUPERIORITY||Difference in Least Squares (LS) Means|-7.53||||0.0002|TWO_SIDED|95.0|-11.48|-3.58||P-values are obtained by fitting an ANCOVA model with treatment as factor and WOMAC baseline pain score as a covariate.|ANCOVA||LS estimates are obtained by fitting an ANCOVA model with treatment as factor and WOMAC baseline pain score as a covariate.|||-3.58|-11.48|0.0002
70875857|NCT01244425|141235646|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||likelihood-ratio chi square test|||||||<0.001
70875858|NCT01244425|141235647|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||likelihood ratio chi-square test|||||||<0.001
70875859|NCT01244425|141235648|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||likelihood ratio chi-square test|||||||0.028
70875860|NCT01244425|141235649|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||likelihood ratio chi-square test|||||||0.017
70875861|NCT01244425|141235650|SUPERIORITY_OR_OTHER|||||||0.293||95.0|||||likelihood ratio chi-square test|||||||0.293
70875862|NCT01244425|141235651|SUPERIORITY_OR_OTHER|||||||0.237||95.0|||||likelihood ratio chi-square test|||||||0.237
70875863|NCT01244425|141235652|SUPERIORITY_OR_OTHER|||||||0.808||95.0|||||likelihood ratio chi-square test|||||||0.808
70875864|NCT02848651|141235716|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.3502|TWO_SIDED|90.0|0.54|1.18|||Log Rank|||||1.18|0.54|0.3502
70875865|NCT02848651|141235723|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.1783|TWO_SIDED|90.0|0.4|1.1|||Log Rank|||||1.10|0.40|0.1783
70875866|NCT02848651|141235723|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.0358|TWO_SIDED|90.0|0.23|0.85|||Log Rank|||||0.85|0.23|0.0358
70875867|NCT02848651|141235724|SUPERIORITY||Differences in Rates|13.27||||0.0326|TWO_SIDED|90.0|2.53|24.0|||Cochran-Mantel-Haenszel|||||24.00|2.53|0.0326
70875868|NCT02848651|141235724|SUPERIORITY||Difference in Rates|30.22|||<|0.0001|TWO_SIDED|90.0|14.82|45.62|||Cochran-Mantel-Haenszel|||||45.62|14.82|<0.0001
70875869|NCT02848651|141235724|SUPERIORITY||Differences in Rates|41.37|||<|0.0001|TWO_SIDED|90.0|22.13|60.61|||Cochran-Mantel-Haenszel|||||60.61|22.13|<0.0001
70956149|NCT00371683|141415841|SUPERIORITY_OR_OTHER|||||||0.1578|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.1578
70956150|NCT00371683|141415842|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.25|||||TWO_SIDED|95.0|0.65|2.4||||||||2.40|0.65|
70956151|NCT00371683|141415842|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.25|||||TWO_SIDED|95.0|-0.47|0.98||||||||0.98|-0.47|
70956152|NCT00371683|141415843|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.46|||||TWO_SIDED|95.0|0.72|2.95||||||||2.95|0.72|
71150187|NCT02558296|141793519|SUPERIORITY|Rejection of the null hypothesis would imply that the mean change in body weight from baseline to Week 48 was less than the mean change in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Net)|-2.65|||<|0.0001|TWO_SIDED|95.0|-3.07|-2.24||P-value is presented based on one-sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline HbA1c and eGFR, history of heart failure, insulin use (Y/N), treatment, visit and baseline body weight as fixed effect covariate.||The null hypothesis for the secondary endpoint was that the mean change in body weight from baseline to Week 48 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-2.24|-3.07|<0.0001
71150188|NCT02558296|141793520|SUPERIORITY|Rejection of the null hypothesis would imply that the mean change in systolic blood pressure from baseline to Week 24 was less than the mean change in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Net)|-2.96||||0.0112|TWO_SIDED|95.0|-5.51|-0.42||P-value is presented based on one-sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline HbA1c, GFR categories, BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline SBP as fixed effect covariate.||The null hypothesis for the secondary endpoint was that the mean change in systolic blood pressure from baseline to Week 24 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.42|-5.51|0.0112
71150189|NCT02558296|141793521|SUPERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 6 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.45|||<|0.0001|TWO_SIDED|95.0|-0.5|-0.39||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 6 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.39|-0.50|<0.0001
70875870|NCT00662363|141235778|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||independent sample t test|||Primary outcome measures chosen were between group comparisons for change on Constipation Symptom Questionnaire ratings at exit from the study. The PAC-SYM is a symptom scale where higher numbers indicate more symptoms. Change from baseline to Day 7 was calculated and larger negative differences indicated greater improvement in constipation symptoms. The PAC-QOL is a quality of life scale where higher numbers indicate better quality of life. Change from baseline to 7 days was calculated.||||<0.05
70875871|NCT01428453|141235780|SUPERIORITY_OR_OTHER||Mean Difference (Net)|39.8||||0.133|TWO_SIDED|95.0|-12.4|92.0|||ANCOVA|The analysis method was ANCOVA adjusted for Treatment, Baseline CSF Abeta1-42 and Age.|Comparison of CSF Abeta42 between placebo and rilapladib 250 mg.|||92.0|-12.4|0.133
70875872|NCT01428453|141235780|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-250.3|STANDARD_ERROR_OF_MEAN|265.66||0.829|TWO_SIDED|95.0|-771.9|271.2|||ANCOVA|The analysis method was ANCOVA adjusted for Treatment, Baseline CSF Abeta1-40 and Age.|Comparison of CSF Abeta40 between placebo and rilapladib 250 mg.|||271.2|-771.9|0.829
70875873|NCT01428453|141235781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.016|||||TWO_SIDED|95.0|-0.003|0.036|||||The analysis method was ANCOVA adjusted for Treatment, Baseline CSF Ratio Abeta1-42/Abeta1-40 and Age.|||0.036|-0.003|
70875874|NCT01428453|141235782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-57.1|STANDARD_ERROR_OF_MEAN|44.4||0.902|TWO_SIDED|95.0|-144.5|30.3|||ANCOVA|The analysis method was ANCOVA adjusted for Treatment, Baseline CSF tau and Age.|Comparison of CSF tau between placebo and rilapladib 250 mg.|||30.3|-144.5|0.902
70875875|NCT01428453|141235782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0|STANDARD_ERROR_OF_MEAN|2.46||0.892|TWO_SIDED|95.0|-7.9|1.8|||ANCOVA|The analysis method was ANCOVA adjusted for Treatment, Baseline CSF P-tau and Age.|Comparison of P-tau between placebo and rilapladib 250 mg.|||1.8|-7.9|0.892
70875876|NCT01428453|141235783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.167||||0.026|TWO_SIDED|95.0|0.021|0.313||The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline Working Memory/Executive Function Composite Score, Treatment by Visit and Baseline Working Memory/Executive Function Composite Score by Visit.|Mixed-Model Repeated Measures analysis||A positive treatment difference indicates benefit, relative to placebo.|||0.313|0.021|0.026
70875877|NCT01428453|141235784|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.256||0.828|TWO_SIDED|95.0|-0.74|0.26|||ANCOVA|The analysis method was ANCOVA adjusted for Treatment, Baseline CSF Albumin Quotient and Age.||||0.26|-0.74|0.828
70875878|NCT01428453|141235785|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3|||||TWO_SIDED|95.0|-3.9|1.2|||Mixed-Model Repeated Measures analysis||Comparison of Abeta42 between placebo and rilapladib 250 mg. The analysis method for Plasma parameters was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline, Treatment by Visit, Baseline by Visit and Age.|||1.2|-3.9|
70875879|NCT01428453|141235785|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0||||||95.0|-10.2|12.2|||Mixed-Model Repeated Measures analysis||Comparison of Abeta40 between placebo and rilapladib 250 mg. The analysis method for Plasma parameters was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline, Treatment by Visit, Baseline by Visit and Age.|||12.2|-10.2|
70875880|NCT01428453|141235786|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.003|||||TWO_SIDED|95.0|-0.016|0.01|||Mixed-Model Repeated Measures analysis||The analysis method for Plasma parameters was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline, Treatment by Visit, Baseline by Visit and Age.|||0.010|-0.016|
70875881|NCT01428453|141235788|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.067|||||TWO_SIDED|95.0|-0.191|0.057|||Mixed-Model Repeated Measures analysis||"The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline Score, Treatment by Visit and Baseline Score by Visit. A positive treatment difference indicates benefit, relative to placebo.~placebo."|||0.057|-0.191|
70956153|NCT00371683|141415843|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.38|||||TWO_SIDED|95.0|-0.3|1.06||||||||1.06|-0.30|
70956154|NCT00371683|141415843|SUPERIORITY_OR_OTHER|||||||0.2873|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.2873
70956155|NCT00371683|141415844|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.74|1.2||||||||1.20|0.74|
70875882|NCT01428453|141235788|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.138||||0.982|TWO_SIDED|95.0|0.01|0.267||The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline Overall Composite Score, Treatment by Visit and Baseline Overall Composite Score by Visit.|Mixed-Model Repeated Measures analysis|The probability (effect size) for change from Baseline in CogState battery overall composite score \>0 is presented.|A positive treatment difference indicates benefit, relative to placebo. Comparison of overall composite score between placebo and rilapladib 250 mg at Week 24.|||0.267|0.010|0.982
70875883|NCT01428453|141235789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.063|||||TWO_SIDED|95.0|-0.257|0.13|||Mixed-Model Repeated Measures analysis|The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline Score, Treatment by Visit and Baseline Score by Visit.|Comparison of attention composite score between placebo and rilapladib 250 mg at Week 12. A positive treatment difference indicates benefit, relative to placebo.|||0.130|-0.257|
70875884|NCT01428453|141235789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|||||TWO_SIDED|95.0|-0.13|0.269|||Mixed-Model Repeated Measures analysis|The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline Score, Treatment by Visit and Baseline Score by Visit.|Comparison of attention composite score between placebo and rilapladib 250 mg at Week 24. A positive treatment difference indicates benefit, relative to placebo.|||0.269|-0.130|
70875885|NCT02607033|141235790|OTHER|Wilxocon signed Rank test||||||0.028|||||||Wilxocon signed Rank test|||Wilxocon signed Rank test to compare pre to post onset of pain time in the Exercise + Weight loss group. Due to low sample size were unable to compare changes between the Exercise + Weight Loss group and the Exercise only groups.||||0.028
70875886|NCT02421315|141235794|OTHER|a t-test comparing groups in a specific region-of-interest (ROI); the insula|Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.057||0.0585|TWO_SIDED|95.0|-0.004|0.224|||t-test, 2 sided|||We hypothesized that compared to HC, children and adolescents with OCD would have increased activation in subcortical structures (insula, and putamen) comprising a right hemisphere dorsal frontostriatal circuit.||0.224|-0.004|0.0585
70875887|NCT02421315|141235795|SUPERIORITY|We selected 'arbitrary units' as the unit of measure here because we are looking at connectivity strengths|Mean Difference (Final Values)|0.49512921|STANDARD_ERROR_OF_MEAN|0.06553315||0.037|TWO_SIDED|||||"NBS controls for family-wise error rate using permutation testing to identify components or clusters of contiguous region-to-region connections. A statistical threshold of p\<.05 with 20,000 permutations was used."|t-test, 1 sided||Direction of the comparison: HC\>OCD|Whole-Brain Connectome-Level Analyses were performed on the FC-strength indices between 352 regions. Edge-wise functional connectivity analyses was then be conducted across the resulting matrix comprised of 352 nodes and 123,904 edges, using the Network-Based Statistics (NBS) Toolbox. We hypothesized that youth with OCD would show altered FC between task-control circuit regions.||||.037
70875888|NCT02421315|141235795|OTHER||Slope|-0.521|||<|0.05|TWO_SIDED||||||Regression, Linear|||Separate cross-lagged panel models were computed in the OCD group for the three functional connections that differed significantly across groups at baseline (see Statistical Analysis 1). These models were constructed using IBM SPSS Amos (v.23) to test for directional relationships between OCD symptoms and FC pre- to post-treatment in the OCD patients. CY-BOCS total scores at each time point were used as the OCD symptoms measure.||||<.05
70875889|NCT02421315|141235796|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.0464|TWO_SIDED|95.0|0.0018|0.218|||t-test, 2 sided|||||0.218|0.0018|0.0464
70875890|NCT02421315|141235797|SUPERIORITY|only participants were assigned to groups (OCD, HC) and we measured streamline count in these participants to index structural connectivity|Slope|-102.67|||<|0.025|TWO_SIDED|||||"NBS controls for family-wise error rate using permutation testing to identify components or clusters of contiguous region-to-region connections. A statistical threshold of p=.025 with 10,000 permutations was used."|Regression, Linear||Direction of comparison: HC\>OCD|Whole-Brain Connectome-Level Analyses were performed on the structural connectivity indices (streamline count) between 164 regions. Edge-wise structural connectivity analyses was then be conducted across the resulting matrix comprised of 164 nodes and 26,896 edges, using the Network-Based Statistics (NBS) Toolbox.||||<0.025
70875891|NCT03789318|141235803|SUPERIORITY|||||||0.2912|||||||ANOVA|||||||0.2912
70875892|NCT03789318|141235804|SUPERIORITY|||||||0.498|||||||ANOVA|||||||0.4980
70875893|NCT03789318|141235805|SUPERIORITY|||||||0.1958|||||||Log Rank|||||||0.1958
70875894|NCT03789318|141235806|SUPERIORITY|||||||0.9546|||||||Regression, Logistic|||||||0.9546
70875895|NCT03789318|141235807|SUPERIORITY|||||||0.4434|||||||ANOVA|||||||0.4434
70875896|NCT02480114|141235808|SUPERIORITY||Odds Ratio (OR)|0.549||||0.004|TWO_SIDED|95.0|0.364|0.827|||Proportional Odds Regression|||||0.827|0.364|0.004
70875897|NCT02480114|141235809|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED||||||Fisher Exact|||||||1
70875898|NCT02480114|141235810|SUPERIORITY||Odds Ratio (OR)|0.371|||<|0.001|TWO_SIDED|95.0|0.244|0.597|||Proportional Odds Regression|||||0.597|0.244|<0.001
70875899|NCT03700671|141235834|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||A P-value of 0.05 was used as the threshold for significance|ANOVA|||A sample size of 38 using G\*Power 3.1 software was calculated based on previously published data in which the mean difference between HIIT and moderate intensity continuous training (MICT) was 3.2 ml.kg-1.min-1 with a pooled standard deviation of 3 ml.kg-1.min-1. Statistical significance was set at = 0.05 and power set to 0.95. To allow for 10% attrition 42 individuals were recruited to the study||||<0.01
70875900|NCT03700671|141235835|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||0.05 was used as a threshold for significance|ANOVA|||||||<0.01
70875901|NCT01317160|141235838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.042|TWO_SIDED||||||Chi-squared|||Domeij-Arverud et al., Bone Joint J 2015;97-B:675-80.||||0.042
70875902|NCT01317160|141235838|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.81|||<|0.05|TWO_SIDED|95.0|1.25|6.32|||Regression, Logistic|Age was adjusted for in the calculation.|Risk of VTE by routine care (numerator) divided by IPC treatment (denominator)|||6.32|1.25|<0.05
70875903|NCT01317160|141235840|SUPERIORITY_OR_OTHER_LEGACY|||||||0.737|TWO_SIDED||||||Chi-squared|||||||0.737
70956156|NCT00371683|141415844|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.83|||||TWO_SIDED|95.0|-3.3|1.63||||||||1.63|-3.30|
70956157|NCT00371683|141415844|SUPERIORITY_OR_OTHER|||||||0.6145|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.6145
70875904|NCT01774968|141235846|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.1||||0.3709|TWO_SIDED|95.0|-0.33|0.12|||Mixed Models Analysis|||Approximately 325 participants were to be randomized (in a 1:1 ratio of U-500R insulin TID:BID) and 260 were to complete the study (with a 20% dropout rate). The 260 completers would provide a 66.4% chance to show equivalence of TID and BID algorithms, 14.4% chance to show noninferiority of TID, 2.5% chance to superiority of TID, 14.4% chance to show noninferiority of BID, and 2.5% chance to show superiority of BID, assuming a difference in HbA1c change of 0% and a standard deviation of 1.1%.||0.12|-0.33|0.3709
70875905|NCT02044393|141235861|NON_INFERIORITY_OR_EQUIVALENCE|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|74.07|STANDARD_ERROR_OF_MEAN|32.1|||TWO_SIDED|90.0|62.371|87.959|||||"ratio of IT+BI 691751 to BI 691751 treatment. Estimated value and its confidence interval (CI) are in percentage unit.~The standard error of the mean actually is the geometric coefficient of variance."|gMean ratio of IT+BI 691751 to BI 69175 treatment (in plasma)||87.959|62.371|
70875906|NCT02044393|141235861|NON_INFERIORITY_OR_EQUIVALENCE|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|86.35|STANDARD_ERROR_OF_MEAN|18.6|||TWO_SIDED|90.0|78.04|95.56|||||"ratio of IT+BI 691751 to BI 691751 treatment. Estimated value and its confidence interval (CI) are in percentage unit.~The standard error of the mean actually is the geometric coefficient of variance."|gMean ratio of IT+BI 691751 to BI 691751 treatment (in whole blood)||95.56|78.04|
70875907|NCT02044393|141235862|NON_INFERIORITY_OR_EQUIVALENCE|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|95.59|STANDARD_ERROR_OF_MEAN|23.5|||TWO_SIDED|90.0|84.195|108.537|||||ratio of test to reference treatment. The standard error of the mean actually is the geometric coefficient of variance.|gMean ratio of test to reference treatment (in plasma)||108.537|84.195|
70875908|NCT02044393|141235862|NON_INFERIORITY_OR_EQUIVALENCE|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|93.54|STANDARD_ERROR_OF_MEAN|15.1|||TWO_SIDED|90.0|86.142|101.57|||||ratio of test to reference treatment. The standard error of the mean actually is the geometric coefficient of variance.|gMean ratio of test to reference treatment (in whole blood)||101.570|86.142|
70875909|NCT02044393|141235863|NON_INFERIORITY_OR_EQUIVALENCE|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|74.86|STANDARD_ERROR_OF_MEAN|32.4|||TWO_SIDED|90.0|62.946|89.035|||||ratio of IT+BI 691751 to BI 691751 treatment. The standard error of the mean actually is the geometric coefficient of variance.|gMean ratio of IT+BI 691751 to BI 691751 treatment (in plasma)||89.035|62.946|
70875910|NCT02044393|141235863|NON_INFERIORITY_OR_EQUIVALENCE|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|88.19|STANDARD_ERROR_OF_MEAN|20.7|||TWO_SIDED|90.0|78.6|98.95|||||ratio of IT+BI 691751 to BI 691751 treatment. The standard error of the mean actually is the geometric coefficient of variance.|gMean ratio of IT+BI 691751 to BI 691751 treatment (in whole blood)||98.95|78.60|
70956158|NCT00371683|141415847|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.25|||||TWO_SIDED|95.0|-0.55|0.05||||||Adjusted difference of event rates of MI/Stroke. Type of surgery was taken into consideration as a stratification factor.||0.05|-0.55|
70956159|NCT00371683|141415847|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.19|||||TWO_SIDED|95.0|-0.46|0.09||||||Adjusted difference of event rates of MI. Type of surgery was taken into consideration as a stratification factor.||0.09|-0.46|
70956160|NCT00371683|141415847|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.13|||||TWO_SIDED|95.0|-0.3|0.05||||||Adjusted difference of event rates of Stroke. Type of surgery was taken into consideration as a stratification factor.||0.05|-0.30|
70875911|NCT02879305|141235879|NON_INFERIORITY|Non-inferiority was achieved if the upper limit of the two-sided 95% CI for the hazard ratio was below the pre-specified non-inferiority margin of 1.25.|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.81|1.07|||||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.07|0.81|
70956161|NCT00371683|141415847|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.13|||||TWO_SIDED|95.0|-0.3|0.05||||||Adjusted difference of event rates of thrombocytopenia. Type of surgery was taken into consideration as a stratification factor.||0.05|-0.30|
70956162|NCT00371683|141415848|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.81|||||TWO_SIDED|95.0|-1.49|-0.14||||||Adjusted difference of event rates of Major Bleeding. Type of surgery was taken into consideration as a stratification factor.||-0.14|-1.49|
70956163|NCT00371683|141415848|SUPERIORITY_OR_OTHER|||||||0.0533|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||Major Bleeding Endpoint||||0.0533
70956164|NCT00371683|141415848|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.77|||||TWO_SIDED|95.0|-1.87|0.33||||||Adjusted difference of event rates of Clinically Relevant Non-Major Bleeding. Type of surgery was taken into consideration as a stratification factor.||0.33|-1.87|
70956165|NCT00371683|141415848|SUPERIORITY_OR_OTHER|||||||0.1709|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||Clinically relevant Non-Major Bleeding endpoint||||0.1709
70956166|NCT00371683|141415848|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.46|||||TWO_SIDED|95.0|-2.75|-0.17||||||Adjusted difference of event rates of Major or Clinically Relevant Non-Major Bleeding. Type of surgery was taken into consideration as a stratification factor.||-0.17|-2.75|
70956167|NCT00371683|141415848|SUPERIORITY_OR_OTHER|||||||0.0338|TWO_SIDED||||||test of equality|For descriptive purposes only, p-values were presented for the test of equality of event rates||Major or Clinically Relevant Non-Major Bleeding endpoint.||||0.0338
70875912|NCT02879305|141235880|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was greater than -0.75 g/dL.|Least square (LS) mean difference|0.18|||||TWO_SIDED|95.0|0.12|0.24|||||Analysis of covariance (ANCOVA) model adjusted for treatment, Baseline Hgb, dialysis type and region along with 95% CI for treatment difference (daprodustat-rhEPO).|||0.24|0.12|
70875913|NCT02879305|141235881|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.156123|TWO_SIDED|95.0|0.81|1.07||The p-value was compared against 0.0125 based on the Holm-Bonferonni adjustment.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.07|0.81|0.156123
70875914|NCT02879305|141235882|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.023539|TWO_SIDED|95.0|0.78|1.0||The p-value was compared against 0.006250 based on the Holm-Bonferonni adjustment.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.00|0.78|0.023539
70875915|NCT02879305|141235883|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.325797|TWO_SIDED|95.0|0.85|1.11||The p-value was compared against 0.025000 based on the Holm-Bonferonni adjustment.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.11|0.85|0.325797
70875916|NCT02879305|141235884|SUPERIORITY||LS mean difference|-9.1||||0.026947|TWO_SIDED|95.0|-18.4|0.2||The p-value was compared against 0.008333 based on the Holm-Bonferonni adjustment.|ANCOVA||Analysis was carried out by using ANCOVA model with terms for treatment, Baseline monthly IV iron dose, dialysis type and region.|||0.2|-18.4|0.026947
70875917|NCT02879305|141235885|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.3281|TWO_SIDED|95.0|0.82|1.13|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.13|0.82|0.3281
70875918|NCT02879305|141235886|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.3553|TWO_SIDED|95.0|0.74|1.23|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.23|0.74|0.3553
70875919|NCT02879305|141235887|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0524|TWO_SIDED|95.0|0.63|1.04|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.04|0.63|0.0524
70875920|NCT02879305|141235888|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.1927|TWO_SIDED|95.0|0.56|1.25|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.25|0.56|0.1927
70875921|NCT02879305|141235889|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.0351|TWO_SIDED|95.0|0.8|1.01|||Chi-squared||Overall HR is presented using Model 1. Model 1 assumed a common treatment effect, regardless of number of events experienced. HR was estimated using a Prentice, Williams and Peterson(PWP) model, with treatment, dialysis type and region as covariates.|||1.01|0.80|0.0351
70875922|NCT02879305|141235889|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.3258|TWO_SIDED|95.0|0.85|1.11|||Chi-squared||First Event Hazard ratio is presented using Model 2. Model 2 assumed treatment effect differs by number of events experienced. Hazard Ratio (HR) was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.11|0.85|0.3258
71150190|NCT02558296|141793521|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 12 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.56|||<|0.0001|TWO_SIDED|95.0|-0.63|-0.49||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 12 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.49|-0.63|<0.0001
71150191|NCT02558296|141793521|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 24 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.47|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.38||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 24 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.38|-0.56|<0.0001
70875923|NCT02879305|141235889|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0158|TWO_SIDED|95.0|0.58|0.98|||Chi-squared||Second Event Hazard ratio is presented using Model 2. Model 2 assumed treatment effect differs by number of events experienced. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||0.98|0.58|0.0158
70875924|NCT02879305|141235889|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0981|TWO_SIDED|95.0|0.47|1.17|||Chi-squared||Third Event Hazard ratio is presented using Model 2. Model 2 assumed treatment effect differs by number of events experienced. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.17|0.47|0.0981
70875925|NCT02879305|141235889|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.3258|TWO_SIDED|95.0|0.85|1.11|||Chi-squared||First Event Hazard ratio is presented using Model 3. Model 3 assumed treatment effect for first event differs from a common effect for subsequent events. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.11|0.85|0.3258
70875926|NCT02879305|141235889|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0058|TWO_SIDED|95.0|0.6|0.94|||Chi-squared||Subsequent Event Hazard ratio is presented using Model 3. Model 3 assumed treatment effect for first event differs from a common effect for subsequent events. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||0.94|0.60|0.0058
70875927|NCT02879305|141235890|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.0872|TWO_SIDED|95.0|0.73|1.06|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.06|0.73|0.0872
70875928|NCT02879305|141235891|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.154|TWO_SIDED|95.0|0.87|1.04|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.04|0.87|0.1540
71150192|NCT02558296|141793521|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 36 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.47|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.38||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 36 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.38|-0.56|<0.0001
71150193|NCT02558296|141793521|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 48 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.46|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.37||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 48 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.37|-0.56|<0.0001
71150194|NCT02558296|141793521|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 72 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.42|||<|0.0001|TWO_SIDED|95.0|-0.54|-0.31||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 72 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.31|-0.54|<0.0001
71150195|NCT02558296|141793521|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 96 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.39|||<|0.0001|TWO_SIDED|95.0|-0.51|-0.27||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 96 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.27|-0.51|<0.0001
71150196|NCT02558296|141793521|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 120 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.43|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.3||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 120 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.30|-0.56|<0.0001
71150197|NCT02558296|141793521|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 144 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.38|||<|0.0001|TWO_SIDED|95.0|-0.54|-0.23||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 144 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.23|-0.54|<0.0001
71150198|NCT02558296|141793521|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 168 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.27||||0.0045|TWO_SIDED|95.0|-0.47|-0.07||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 168 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.07|-0.47|0.0045
71150199|NCT02558296|141793522|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 6 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.35|||<|0.0001|TWO_SIDED|95.0|-1.55|-1.15||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 6 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-1.15|-1.55|<0.0001
71150200|NCT02558296|141793522|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 12 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.39|||<|0.0001|TWO_SIDED|95.0|-1.61|-1.18||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 12 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-1.18|-1.61|<0.0001
71150201|NCT02558296|141793522|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 24 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.39|||<|0.0001|TWO_SIDED|95.0|-1.61|-1.16||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 24 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-1.16|-1.61|<0.0001
70875929|NCT02879305|141235892|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.1244|TWO_SIDED|95.0|0.77|1.07|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.07|0.77|0.1244
70875930|NCT02879305|141235893|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.054|TWO_SIDED|95.0|0.81|1.02|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.02|0.81|0.0540
70875931|NCT02879305|141235894|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.7658|TWO_SIDED|95.0|0.84|1.45|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.45|0.84|0.7658
70875932|NCT02879305|141235895|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0425|TWO_SIDED|95.0|0.69|1.02|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.02|0.69|0.0425
70875933|NCT02879305|141235896|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was greater than the pre-specified non-inferiority margin of -0.75 g/dL.|LS mean difference|0.12|||||TWO_SIDED|95.0|0.03|0.21||||||||0.21|0.03|
70875934|NCT02879305|141235897|SUPERIORITY||Difference in response rate|3.5||||0.0367|TWO_SIDED|95.0|-0.1|7.1|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel (CMH) test adjusted for dialysis type, and region was used to compare the number of responders between the treatment groups.|||7.1|-0.1|0.0367
70875935|NCT02879305|141235898|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% confidence interval for the treatment difference was greater than non-inferiority margin of -15%.|Median Difference (Final Values)|1.06|||||TWO_SIDED|95.0|0.0|3.86|||||Hodges-Lehmann estimate of the treatment difference (daprodustat-rhEPO) and associated two-sided asymptotic 95% CI is presented.|||3.86|0.00|
70875936|NCT02879305|141235899|SUPERIORITY||Probability|0.52||||0.0805|TWO_SIDED|95.0|0.49|0.54|||van Elteren test||Mann-Whitney estimate (Probability) of the treatment effect has been presented.|||0.54|0.49|0.0805
70875937|NCT02879305|141235900|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% confidence interval for the treatment difference was greater than non-inferiority margin of -15%.|Median Difference (Final Values)|2.18|||||TWO_SIDED|95.0|0.28|4.05|||||Hodges-Lehmann estimate of the treatment difference (daprodustat-rhEPO) and associated two-sided asymptotic 95% CI is presented.|||4.05|0.28|
70875938|NCT02879305|141235901|SUPERIORITY||Probability|0.53||||0.0139|TWO_SIDED|95.0|0.5|0.55|||van Elteren test||Mann-Whitney estimate (Probability) of the treatment effect has been presented.|||0.55|0.50|0.0139
70875939|NCT02879305|141235902|SUPERIORITY||LS mean difference|0.33||||0.6551|TWO_SIDED|95.0|-1.28|1.94|||MMRM||The difference in change from Baseline in SBP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in means between arms.|||1.94|-1.28|0.6551
70875940|NCT02879305|141235902|SUPERIORITY||LS mean difference|-0.46||||0.1586|TWO_SIDED|95.0|-1.36|0.44|||MMRM||The difference in change from Baseline in DBP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in means between arms.|||0.44|-1.36|0.1586
70875941|NCT02879305|141235902|SUPERIORITY||LS mean difference|-0.18||||0.3646|TWO_SIDED|95.0|-1.2|0.84|||MMRM||The difference in change from Baseline in MAP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in means between arms.|||0.84|-1.20|0.3646
70875942|NCT02879305|141235903|SUPERIORITY||LS mean difference|0.0||||0.5012|TWO_SIDED|95.0|-1.54|1.54|||ANCOVA||For SBP: Treatment group comparisons were based on an ANCOVA model with terms for treatment group, dialysis type, region and Baseline value.|||1.54|-1.54|0.5012
70875943|NCT02879305|141235903|SUPERIORITY||LS mean difference|0.45||||0.8451|TWO_SIDED|95.0|-0.42|1.31|||ANCOVA||For DBP: Treatment group comparisons were based on an ANCOVA model with terms for treatment group, dialysis type, region and Baseline value.|||1.31|-0.42|0.8451
70875944|NCT02879305|141235903|SUPERIORITY||LS mean difference|0.31||||0.7312|TWO_SIDED|95.0|-0.67|1.28|||ANCOVA||For MAP: Treatment group comparisons were based on an ANCOVA model with terms for treatment group, dialysis type, region and Baseline value.|||1.28|-0.67|0.7312
70875945|NCT02879305|141235904|SUPERIORITY||Ratio of exacerbation rate|1.0||||0.529|TWO_SIDED|95.0|0.91|1.11|||Negative binomial model||Ratio of model estimated exacerbation rates and CIs were estimated using a negative binomial model for the treatment group comparison.|||1.11|0.91|0.5290
70875946|NCT02879305|141235906|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.5772|TWO_SIDED|95.0|0.71|1.52|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model adjusted for treatment group, dialysis type and region.|||1.52|0.71|0.5772
70875947|NCT02879305|141235907|SUPERIORITY||LS mean difference|0.29||||0.162|TWO_SIDED|95.0|-0.29|0.86|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and the model adjusted Week 8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.86|-0.29|0.1620
70875948|NCT02879305|141235907|SUPERIORITY||LS mean difference|0.61||||0.018|TWO_SIDED|95.0|0.04|1.18|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and the model adjusted Week 12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.18|0.04|0.0180
70875949|NCT02879305|141235907|SUPERIORITY||LS mean difference|0.33||||0.153|TWO_SIDED|95.0|-0.31|0.97|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and the model adjusted Week 28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.97|-0.31|0.1530
70956168|NCT00371683|141415848|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.52|||||TWO_SIDED|95.0|-3.18|0.13||||||Adjusted difference of event rates of Any Bleeding. Type of surgery was taken into consideration as a stratification factor.||0.13|-3.18|
70956169|NCT00371683|141415848|SUPERIORITY_OR_OTHER|||||||0.0816|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||Any Bleeding Endpoint.||||0.0816
70956170|NCT01151410|141415899|NON_INFERIORITY_OR_EQUIVALENCE|Indicates statistical significance at 0.025 level for one sided non-inferiority testing at 4mmHg margin.|Mean Difference (Net)|0.31||||0.004|ONE_SIDED|95.0|-2.4||||ANCOVA||||||-2.40|0.0040
70956171|NCT04602221|141415902|OTHER||Difference of adjusted means|-0.339|STANDARD_ERROR_OF_MEAN|3.8242||0.9296|TWO_SIDED|95.0|-7.975|7.297|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the primary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||7.297|-7.975|0.9296
70956172|NCT04602221|141415902|OTHER||Difference of adjusted means|4.002|STANDARD_ERROR_OF_MEAN|3.8224||0.299|TWO_SIDED|95.0|-3.631|11.634|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the primary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||11.634|-3.631|0.2990
71150202|NCT02558296|141793522|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 36 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.41|-0.89||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 36 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.89|-1.41|<0.0001
71150203|NCT02558296|141793522|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 48 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.23|||<|0.0001|TWO_SIDED|95.0|-1.48|-0.98||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 48 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.98|-1.48|<0.0001
71150204|NCT02558296|141793522|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 72 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.99|||<|0.0001|TWO_SIDED|95.0|-1.27|-0.72||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 72 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.72|-1.27|<0.0001
71150205|NCT02558296|141793522|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 96 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.9||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 96 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.90|-1.50|<0.0001
70956173|NCT04602221|141415902|OTHER||Difference of adjusted means|-1.258|STANDARD_ERROR_OF_MEAN|3.6608||0.7322|TWO_SIDED|95.0|-8.565|6.05|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the primary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||6.050|-8.565|0.7322
70956174|NCT04602221|141415903|OTHER||Difference of adjusted means|0.347|STANDARD_ERROR_OF_MEAN|1.563||0.8249|TWO_SIDED|95.0|-2.776|3.471|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the secondary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||3.471|-2.776|0.8249
70956175|NCT04602221|141415903|OTHER||Difference of adjusted means|-1.085|STANDARD_ERROR_OF_MEAN|1.5889||0.4973|TWO_SIDED|95.0|-4.26|2.091|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the secondary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||2.091|-4.260|0.4973
70956176|NCT04602221|141415903|OTHER||Difference of adjusted means|-2.858|STANDARD_ERROR_OF_MEAN|1.5266||0.0658|TWO_SIDED|95.0|-5.909|0.192|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the secondary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||0.192|-5.909|0.0658
70956177|NCT04602221|141415904|OTHER||Difference of adjusted means|0.0053|STANDARD_ERROR_OF_MEAN|0.00798||0.5081|TWO_SIDED|95.0|-0.0106|0.0213|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the secondary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||0.0213|-0.0106|0.5081
71150206|NCT02558296|141793522|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 120 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.49|-0.82||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 120 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.82|-1.49|<0.0001
71150207|NCT02558296|141793522|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 144 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.63||||0.0008|TWO_SIDED|95.0|-1.01|-0.24||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 144 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.24|-1.01|0.0008
71150208|NCT02558296|141793522|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 168 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.5||||0.0462|TWO_SIDED|95.0|-1.09|0.08||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 168 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||0.08|-1.09|0.0462
71150209|NCT02558296|141793523|SUPERIORITY||Odds Ratio (OR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.22|0.41||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Logistic|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Odds ratio is calculated as the odds ratio of bexagliflozin over placebo.|||0.41|0.22|<0.0001
71150210|NCT02558296|141793524|SUPERIORITY||Hazard Ratio (HR)|0.41|||<|0.0001|TWO_SIDED|95.0|0.35|0.49||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Cox|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Hazard ratio and p-value were estimated using Cox regression model for time to first event in the bexagliflozin arm vs. placebo arm during entire study.|||0.49|0.35|<0.0001
71150211|NCT02558296|141793525|SUPERIORITY||Odds Ratio (OR)|2.04||||0.0005|TWO_SIDED|95.0|1.33|3.11||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Logistic|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Odds ratio is calculated as the ratio of bexagliflozin over placebo.|||3.11|1.33|0.0005
71150212|NCT02558296|141793526|SUPERIORITY||Hazard Ratio (HR)|1.82|||<|0.0001|TWO_SIDED|95.0|1.4|2.38||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Cox|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Hazard ratio and p-value were estimated using Cox regression model for time to first event in the bexagliflozin arm vs. placebo arm during the entire study.|||2.38|1.40|<0.0001
70875950|NCT02879305|141235907|SUPERIORITY||LS mean difference|0.53||||0.0686|TWO_SIDED|95.0|-0.17|1.22|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and the model adjusted Week 52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.22|-0.17|0.0686
70875951|NCT02879305|141235908|SUPERIORITY||LS mean difference|-0.17||||0.6807|TWO_SIDED|95.0|-0.88|0.54|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and the model adjusted Week 8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.54|-0.88|0.6807
70875952|NCT02879305|141235908|SUPERIORITY||LS mean difference|0.17||||0.3256|TWO_SIDED|95.0|-0.57|0.91|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and the model adjusted Week 12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.91|-0.57|0.3256
70875953|NCT02879305|141235908|SUPERIORITY||LS mean difference|-0.01||||0.5144|TWO_SIDED|95.0|-0.81|0.78|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and the model adjusted Week 28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.78|-0.81|0.5144
70875954|NCT02879305|141235908|SUPERIORITY||LS mean difference|-0.6||||0.912|TWO_SIDED|95.0|-1.47|0.27|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and the model adjusted Week 52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.27|-1.47|0.9120
70875955|NCT02879305|141235909|SUPERIORITY||LS mean difference|-0.25||||0.7432|TWO_SIDED|95.0|-0.99|0.5|||MMRM||Bodily pain,Week8: Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.50|-0.99|0.7432
70875956|NCT02879305|141235909|SUPERIORITY||LS mean difference|0.58||||0.0631|TWO_SIDED|95.0|-0.16|1.33|||MMRM||Bodily pain,Week12: Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.33|-0.16|0.0631
70875957|NCT02879305|141235909|SUPERIORITY||LS mean difference|0.04||||0.4604|TWO_SIDED|95.0|-0.79|0.87|||MMRM||Bodily pain,Week28: Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.87|-0.79|0.4604
71150213|NCT02558296|141793527|SUPERIORITY||Odds Ratio (OR)|0.63||||0.0803|TWO_SIDED|95.0|0.33|1.2||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Logistic|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Odds ratio is calculated as the odds ratio of bexagliflozin over placebo.|||1.20|0.33|0.0803
71150214|NCT02558296|141793527|SUPERIORITY||Odds Ratio (OR)|0.47||||0.0272|TWO_SIDED|95.0|0.22|1.01||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Logistic|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Odds ratio is calculated as the odds ratio of bexagliflozin over placebo.|||1.01|0.22|0.0272
71150215|NCT02558296|141793527|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0757|TWO_SIDED|95.0|0.34|1.18||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Cox|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Hazard ratio and p-value were estimated using Cox regression model for treatment comparison vs. placebo.|||1.18|0.34|0.0757
71150216|NCT02558296|141793527|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.0273|TWO_SIDED|95.0|0.23|1.01||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Cox|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Hazard ratio and p-value were estimated using Cox regression model for treatment comparison vs. placebo.|||1.01|0.23|0.0273
71150217|NCT00297258|141793528|SUPERIORITY_OR_OTHER||percentage of participants|46.0||||0.653||90.0|11.0|47.6|||binomial exact method||The estimated value represents the percentage of participants with a CR, a PR, or SD.|||47.6|11.0|0.653
71150218|NCT00297258|141793528|SUPERIORITY_OR_OTHER||percentage of participants|41.0||||0.003||90.0|28.4|55.5|||binomial exact method||The estimated value represents the percentage of participants with a CR, a PR, or SD.|||55.5|28.4|0.003
71150219|NCT00297258|141793528|SUPERIORITY_OR_OTHER||percentage of participants|49.0|||<|0.001||90.0|34.3|63.2|||binomial exact method||The estimated value represents the percentage of participants with a CR, a PR, or SD.|||63.2|34.3|<0.001
71150220|NCT00297258|141793528|SUPERIORITY_OR_OTHER||percentage of participants|41.0||||0.003||90.0|28.4|55.5|||binomial exact method||The estimated value represents the percentage of participants with a CR, a PR, or SD.|||55.5|28.4|0.003
71150221|NCT05038982|141793542|SUPERIORITY||Mean Difference (Net)|78.26|STANDARD_ERROR_OF_MEAN|16.15|<|0.001|TWO_SIDED|95.0|38.09|118.48||Threshold of significance at 0.05.|ANOVA||Percent PP-NRS reduction comparing subject's values at Week 0 to values at Week 12|||118.48|38.09|<0.001
71150222|NCT05038982|141793542|SUPERIORITY||Mean Difference (Net)|53.66|STANDARD_ERROR_OF_MEAN|18.12||0.0142|TWO_SIDED|95.0|8.55|98.76||Threshold of significance at 0.05.|ANOVA||Percent PP-NRS reduction comparing subject's values at Week 0 to values at Week 12|||98.76|8.55|0.0142
71150223|NCT05038982|141793544|SUPERIORITY||Mean Difference (Net)|9.4|STANDARD_ERROR_OF_MEAN|1.37||0.002|TWO_SIDED|95.0|6.3|12.5||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||12.5|6.3|0.002
71150224|NCT05038982|141793544|SUPERIORITY||Mean Difference (Net)|6.1|STANDARD_ERROR_OF_MEAN|1.99||0.0215|TWO_SIDED|95.0|1.6|10.6||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||10.6|1.6|0.0215
71150225|NCT05038982|141793545|SUPERIORITY||Mean Difference (Net)|10.1|STANDARD_ERROR_OF_MEAN|1.86||0.002|TWO_SIDED|95.0|5.9|14.3||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||14.3|5.9|0.002
71150226|NCT05038982|141793545|SUPERIORITY||Mean Difference (Net)|4.7|STANDARD_ERROR_OF_MEAN|1.74||0.02|TWO_SIDED|95.0|0.77|8.6||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||8.6|0.77|0.02
71150227|NCT05038982|141793546|SUPERIORITY||Mean Difference (Net)|5.44|STANDARD_ERROR_OF_MEAN|1.21||0.0078|TWO_SIDED|95.0|2.7|8.18||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||8.18|2.70|0.0078
71150228|NCT05038982|141793547|SUPERIORITY||Mean Difference (Net)|12.73|STANDARD_ERROR_OF_MEAN|3.16||0.0098|TWO_SIDED|95.0|5.57|19.89||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||19.89|5.57|0.0098
71150229|NCT05038982|141793547|SUPERIORITY||Mean Difference (Net)|9.88|STANDARD_ERROR_OF_MEAN|3.0||0.0117|TWO_SIDED|95.0|3.1|16.66||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||16.66|3.10|0.0117
71150230|NCT05038982|141793548|SUPERIORITY||Mean Difference (Net)|10.2|STANDARD_ERROR_OF_MEAN|2.54||0.002|TWO_SIDED|95.0|4.46|15.94||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||15.94|4.46|0.002
71150231|NCT05038982|141793549|SUPERIORITY||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|0.23||0.0078|TWO_SIDED|95.0|0.57|1.63||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||1.63|0.57|0.0078
71150232|NCT05038982|141793550|SUPERIORITY||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.055||0.0391|TWO_SIDED|95.0|0.025|0.27||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||0.27|0.025|0.0391
71150233|NCT05038982|141793550|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.086||0.28|TWO_SIDED|95.0|-0.08|0.31||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||0.31|-.080|0.28
71150234|NCT05038982|141793551|SUPERIORITY||Mean Difference (Net)|3.6|STANDARD_ERROR_OF_MEAN|1.607||0.0684|TWO_SIDED|95.0|0.035|7.235||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||7.235|0.035|0.0684
71150235|NCT05038982|141793551|SUPERIORITY||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|1.13||0.375|TWO_SIDED|95.0|-3.656|1.456||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||||1.456|-3.656|0.375
71150236|NCT05038982|141793552|SUPERIORITY||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|1.212||0.207|TWO_SIDED|95.0|-3.44|2.04||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||2.04|-3.44|0.207
71150237|NCT05038982|141793552|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|1.498||0.8125|TWO_SIDED|95.0|-3.389|3.389||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||3.389|-3.389|0.8125
71150238|NCT05038982|141793553|SUPERIORITY||Mean Difference (Net)|4.8|STANDARD_ERROR_OF_MEAN|1.009||0.0039|TWO_SIDED|95.0|2.52|7.08||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||7.08|2.52|0.0039
71150239|NCT05038982|141793553|SUPERIORITY||Mean Difference (Net)|2.3|STANDARD_ERROR_OF_MEAN|1.033||0.0547|TWO_SIDED|95.0|-0.0376|4.638||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||4.638|-0.0376|0.0547
71150240|NCT05038982|141793554|SUPERIORITY||Mean Difference (Net)|9.0||||0.0003|TWO_SIDED|95.0|6.93|11.07||Threshold of significance at 0.05.|t-test, 2 sided|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||11.07|6.93|0.0003
71150241|NCT05038982|141793555|SUPERIORITY||Mean Difference (Net)|6.429|||<|0.0001|TWO_SIDED|95.0|4.011|8.846||Threshold of significance at 0.05.|t-test, 2 sided|||||8.846|4.011|<0.0001
71150242|NCT05038982|141793557|SUPERIORITY||Median Difference (Net)|-0.58|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.83|-0.33||Threshold of significance set at 0.05|t-test, 2 sided|||This is a comparison of Th1 GSVA from RNA sequencing (RNASeq) performed on skin biopsies. The comparison is for CPUO patient skin at Week 0 versus Week 12 (end of treatment) The CPUO patients only had one biopsy collected at the timepoints because there are no visible lesions. CPUO patients only had one biopsy taken which will be referred to as Lesional sites. CPUO will compare Lesional biopsies at week 0 to Lesional biopsies at week 12.||-0.33|-0.83|<0.0001
71150243|NCT05038982|141793557|SUPERIORITY||Mean Difference (Net)|-0.37|STANDARD_ERROR_OF_MEAN|0.091||0.0003|TWO_SIDED|95.0|-0.56|-0.18||The threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th2 GSVA from RNASeq performed on skin biopsies. The comparison is for CPUO patient skin at Week 0 versus Week 12 (end of treatment) The CPUO patients only had one biopsy collected at the timepoints because there are no visible lesions. CPUO patients only had one biopsy taken which will be referred to as Lesional sites. CPUO will compare Lesional biopsies at week 0 to Lesional biopsies at week 12.||-0.18|-0.56|0.0003
70875958|NCT02879305|141235909|SUPERIORITY||LS mean difference|0.28||||0.2688|TWO_SIDED|95.0|-0.6|1.15|||MMRM||Bodily pain,Week52: Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.15|-0.60|0.2688
70875959|NCT02879305|141235909|SUPERIORITY||LS mean difference|0.26||||0.1918|TWO_SIDED|95.0|-0.32|0.84|||MMRM||General health,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.84|-0.32|0.1918
70875960|NCT02879305|141235909|SUPERIORITY||LS mean difference|0.45||||0.0677|TWO_SIDED|95.0|-0.14|1.04|||MMRM||General health,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||1.04|-0.14|0.0677
70875961|NCT02879305|141235909|SUPERIORITY||LS mean difference|-0.33||||0.8386|TWO_SIDED|95.0|-0.98|0.32|||MMRM||General health,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||0.32|-0.98|0.8386
70875962|NCT02879305|141235909|SUPERIORITY||LS mean difference|-0.29||||0.7928|TWO_SIDED|95.0|-0.99|0.41|||MMRM||General health,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||0.41|-0.99|0.7928
71150244|NCT05038982|141793557|SUPERIORITY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.12||0.0952|TWO_SIDED|95.0|-0.47|0.039||The threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th17 GSVA from RNASeq performed on skin biopsies. The comparison is for CPUO patient skin at Week 0 versus Week 12 (end of treatment) The CPUO patients only had one biopsy collected at the timepoints because there are no visible lesions. CPUO patients only had one biopsy taken which will be referred to as Lesional sites. CPUO will compare Lesional biopsies at week 0 to Lesional biopsies at week 12.||0.039|-0.47|0.0952
71150245|NCT05038982|141793557|SUPERIORITY||Mean Difference (Net)|-0.38|STANDARD_ERROR_OF_MEAN|0.12||0.004|TWO_SIDED|95.0|-0.64|-0.13||Threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th22 GSVA from RNASeq performed on skin biopsies. The comparison is for CPUO patient skin at Week 0 versus Week 12 (end of treatment) The CPUO patients only had one biopsy collected at the timepoints because there are no visible lesions. CPUO patients only had one biopsy taken which will be referred to as Lesional sites. CPUO will compare Lesional biopsies at week 0 to Lesional biopsies at week 12.||-0.13|-0.64|0.004
70875963|NCT02879305|141235909|SUPERIORITY||LS mean difference|0.04||||0.4537|TWO_SIDED|95.0|-0.63|0.71|||MMRM||Mental health,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.71|-0.63|0.4537
70875964|NCT02879305|141235909|SUPERIORITY||LS mean difference|-0.05||||0.5548|TWO_SIDED|95.0|-0.74|0.65|||MMRM||Mental health,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||0.65|-0.74|0.5548
70875965|NCT02879305|141235909|SUPERIORITY||LS mean difference|0.13||||0.3626|TWO_SIDED|95.0|-0.61|0.88|||MMRM||Mental health,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||0.88|-0.61|0.3626
70875966|NCT02879305|141235909|SUPERIORITY||LS mean difference|-0.81||||0.9721|TWO_SIDED|95.0|-1.64|0.02|||MMRM||Mental health,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||0.02|-1.64|0.9721
70875967|NCT02879305|141235909|SUPERIORITY||LS mean difference|-0.09||||0.5789|TWO_SIDED|95.0|-0.96|0.78|||MMRM||Role-emotional,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.78|-0.96|0.5789
70875968|NCT02879305|141235909|SUPERIORITY||LS mean difference|0.37||||0.2054|TWO_SIDED|95.0|-0.51|1.24|||MMRM||Role-emotional,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||1.24|-0.51|0.2054
70956178|NCT04602221|141415904|OTHER||Difference of adjusted means|0.0058|STANDARD_ERROR_OF_MEAN|0.00798||0.4723|TWO_SIDED|95.0|-0.0102|0.0217|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the secondary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||0.0217|-0.0102|0.4723
70956179|NCT04602221|141415904|OTHER||Difference of adjusted means|0.0333|STANDARD_ERROR_OF_MEAN|0.00767|<|0.0001|TWO_SIDED|95.0|0.018|0.0486|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the secondary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||0.0486|0.0180|< .0001
70956180|NCT02327351|141415905|SUPERIORITY||survival distribution function|86.0||||0.95|TWO_SIDED|95.0|79.0|94.0|||Gray test|||||94|79|0.95
70956181|NCT02327351|141415911|SUPERIORITY|||||||0.35|||||||Log Rank|||||||0.35
71150246|NCT05038982|141793557|SUPERIORITY||Mean Difference (Net)|-0.43|STANDARD_ERROR_OF_MEAN|0.18||0.0277|TWO_SIDED|95.0|-0.81|-0.053||The threshold of significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th1 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 0 versus non lesional PN patient skin at week 0.||-0.053|-0.81|0.0277
70956182|NCT03988920|141415912|SUPERIORITY||Odds Ratio (OR)|0.9||||0.7439|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.7439
71150247|NCT05038982|141793557|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.077|TWO_SIDED|95.0|-0.85|0.049||The threshold of significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th1 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 12 versus non lesional PN patient skin at week 12.||0.049|-0.85|0.077
71150248|NCT05038982|141793557|SUPERIORITY||Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.15||0.0363|TWO_SIDED|95.0|-0.64|-0.024||The threshold of significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th2 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 0 versus non lesional PN patient skin at Week 0.||-0.024|-0.64|0.0363
71150249|NCT05038982|141793557|SUPERIORITY||Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.17||0.1|TWO_SIDED|95.0|-0.63|0.062||The threshold of significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th2 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 12 versus non lesional PN patient skin at Week 12.||0.062|-0.63|0.10
71150250|NCT05038982|141793557|SUPERIORITY||Mean Difference (Net)|-0.58|STANDARD_ERROR_OF_MEAN|0.15||0.0009|TWO_SIDED|95.0|-0.89|-0.27||The threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th17 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 0 versus non lesional PN patient skin at Week 0.||-0.27|-0.89|0.0009
71150251|NCT05038982|141793557|SUPERIORITY||Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|0.23||0.2326|TWO_SIDED|95.0|-0.77|0.2||The threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th17 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 12 versus non lesional PN patient skin at Week 12.||0.20|-0.77|0.2326
71150252|NCT05038982|141793557|SUPERIORITY||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.16||0.0047|TWO_SIDED|95.0|-0.85|-0.18||The threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th22 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 0 versus non lesional PN patient skin at Week 0.||-0.18|-0.85|0.0047
71150253|NCT05038982|141793557|SUPERIORITY||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|0.2||0.0539|TWO_SIDED|95.0|-0.83|0.0076||The threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th22 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 12 versus non lesional PN patient skin at Week 12.||0.0076|-0.83|0.0539
71150254|NCT03070964|141793579|SUPERIORITY||Exact binomial estimator|16.7|||||TWO_SIDED|95.0|2.1|48.4||||||||48.4|2.1|
71150255|NCT02379091|141793593|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.351||0.086|TWO_SIDED|95.0|-1.31|0.09||MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment, visit and previously failed medication, and visit and baseline value.|ANOVA|Baseline values were used as a covariate and participant as a random effect with an unstructured covariance structure.|Namilumab - Placebo|||0.09|-1.31|0.086
71150256|NCT02379091|141793593|SUPERIORITY_OR_OTHER||LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|0.366||0.107|TWO_SIDED|95.0|-1.32|0.13||MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment, visit and previously failed medication, and visit and baseline value.|ANOVA|Baseline values were used as a covariate and subject as a random effect with an unstructured covariance structure.|Namilumab - Placebo|||0.13|-1.32|0.107
71150257|NCT02379091|141793593|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.347||0.01|TWO_SIDED|95.0|-1.61|-0.23||MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment, visit and previously failed medication, and visit and baseline value.|ANOVA|Baseline values were used as a covariate and subject as a random effect with an unstructured covariance structure.|Namilumab - Placebo|||-0.23|-1.61|0.010
71150258|NCT02129699|141793604|SUPERIORITY|Pre-specified analysis|Hazard Ratio (HR)|0.96||||0.355|TWO_SIDED|95.0|0.78|1.19|||Regression, Cox|Cox regression model for treatment effect, analysis adjusted for stratification factors||||1.19|0.78|0.355
71150259|NCT02129699|141793605|SUPERIORITY|Pre-specified analysis|Hazard Ratio (HR)|0.99||||0.459|TWO_SIDED|95.0|0.82|1.19|||Regression, Cox|||||1.19|0.82|0.459
71150260|NCT01357850|141793667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0119||||0.7873|TWO_SIDED|95.0|-0.0768|0.1005|||ANOVA|||||0.1005|-0.0768|0.7873
71150261|NCT01357850|141793667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0678||||0.0499|TWO_SIDED|95.0|0.0|0.1356|||ANOVA|||||0.1356|0.0000|0.0499
71150262|NCT01357850|141793667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0467||||0.1666|TWO_SIDED|95.0|-0.0204|0.1137|||ANOVA|||||0.1137|-0.0204|0.1666
71150263|NCT01357850|141793668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|134.89||||0.9343|TWO_SIDED|95.0|-3172.05|3441.83|||ANOVA|||||3441.83|-3172.05|0.9343
71150264|NCT01357850|141793668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1278.77||||0.3375|TWO_SIDED|95.0|-1398.13|3955.68|||ANOVA|||||3955.68|-1398.13|0.3375
70956183|NCT01237587|141415924|SUPERIORITY||LS mean change difference|-0.65|STANDARD_ERROR_OF_MEAN|0.33||0.052|TWO_SIDED|95.0|-1.3|0.0|||Repeated Measures|||||0.00|-1.30|0.052
70956184|NCT01237587|141415925|SUPERIORITY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.36||0.059|TWO_SIDED|95.0|-1.4|0.03|||Mixed Models Analysis|||Worst Pain||0.03|-1.40|.059
70956185|NCT01237587|141415925|SUPERIORITY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.319||0.059|TWO_SIDED|95.0|-1.24|0.02|||Mixed Models Analysis|||Least Pain||0.02|-1.24|0.059
70956186|NCT01237587|141415925|SUPERIORITY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.365||0.165|TWO_SIDED|95.0|-1.23|0.21|||Mixed Models Analysis|||Pain Right Now||0.21|-1.23|.165
70956187|NCT01237587|141415925|SUPERIORITY||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.344||0.005|TWO_SIDED|95.0|-1.65|-0.3|||Mixed Models Analysis|||General Activity||-0.30|-1.65|0.005
70875969|NCT02879305|141235909|SUPERIORITY||LS mean difference|-0.05||||0.5389|TWO_SIDED|95.0|-0.98|0.89|||MMRM||Role-emotional,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||0.89|-0.98|0.5389
70875970|NCT02879305|141235909|SUPERIORITY||LS mean difference|0.09||||0.4289|TWO_SIDED|95.0|-0.91|1.09|||MMRM||Role-emotional,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||1.09|-0.91|0.4289
70875971|NCT02879305|141235909|SUPERIORITY||LS mean difference|0.08||||0.4096|TWO_SIDED|95.0|-0.6|0.75|||MMRM||Role-physical,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.75|-0.60|0.4096
70875972|NCT02879305|141235909|SUPERIORITY||LS mean difference|0.4||||0.1196|TWO_SIDED|95.0|-0.27|1.07|||MMRM||Role-physical,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions|||1.07|-0.27|0.1196
70875973|NCT02879305|141235909|SUPERIORITY||LS mean difference|0.3||||0.2093|TWO_SIDED|95.0|-0.42|1.01|||MMRM||Role-physical,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions|||1.01|-0.42|0.2093
70956188|NCT01237587|141415925|SUPERIORITY||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.356||0.128|TWO_SIDED|95.0|-1.25|0.16|||Mixed Models Analysis|||Mood||0.16|-1.25|.128
71150265|NCT01357850|141793668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|772.7||||0.5582|TWO_SIDED|95.0|-1887.77|3433.17|||ANOVA|||||3433.17|-1887.77|0.5582
71150266|NCT01357850|141793669|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.06||||0.2256|TWO_SIDED|95.0|-5.43|1.3|||ANOVA|||||1.30|-5.43|0.2256
71150267|NCT01357850|141793669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95||||0.5647|TWO_SIDED|95.0|-4.22|2.32|||ANOVA|||||2.32|-4.22|0.5647
71150268|NCT01357850|141793669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.8942|TWO_SIDED|95.0|-2.44|2.79|||ANOVA|||||2.79|-2.44|0.8942
71150269|NCT03847896|141793724|SUPERIORITY||Mean Difference (Final Values)|60.5||||0.025|TWO_SIDED|95.0|7.7|113.4|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||113.4|7.7|0.025
71150270|NCT03847896|141793724|SUPERIORITY||Mean Difference (Final Values)|161.9|||<|0.001|TWO_SIDED|95.0|109.4|214.5|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||214.5|109.4|<0.001
71150271|NCT03847896|141793724|SUPERIORITY||Mean Difference (Final Values)|80.7||||0.003|TWO_SIDED|95.0|28.4|132.9|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||132.9|28.4|0.003
70875974|NCT02879305|141235909|SUPERIORITY||LS mean difference|0.39||||0.1674|TWO_SIDED|95.0|-0.4|1.19|||MMRM||Role-physical,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions|||1.19|-0.40|0.1674
70875975|NCT02879305|141235909|SUPERIORITY||LS mean difference|-0.14||||0.6585|TWO_SIDED|95.0|-0.82|0.54|||MMRM||Social fun, Week 8: Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.54|-0.82|0.6585
70875976|NCT02879305|141235909|SUPERIORITY||LS mean difference|0.69||||0.0293|TWO_SIDED|95.0|-0.03|1.4|||MMRM||Social fun, Week 12: Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.40|-0.03|0.0293
70875977|NCT02879305|141235909|SUPERIORITY||LS mean difference|0.33||||0.2057|TWO_SIDED|95.0|-0.45|1.11|||MMRM||Social fun, Week 28: Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.11|-0.45|0.2057
70875978|NCT02879305|141235909|SUPERIORITY||LS mean difference|0.02||||0.4849|TWO_SIDED|95.0|-0.86|0.9|||MMRM||Social fun, Week 52: Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.90|-0.86|0.4849
70875979|NCT02879305|141235910|SUPERIORITY||LS mean difference|0.03||||0.4621|TWO_SIDED|95.0|-0.58|0.64|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and model adjusted Week 8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.64|-0.58|0.4621
70875980|NCT02879305|141235910|SUPERIORITY||LS mean difference|0.35||||0.1439|TWO_SIDED|95.0|-0.29|0.98|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and model adjusted Week 12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.98|-0.29|0.1439
70956189|NCT01237587|141415925|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.352||0.56|TWO_SIDED|95.0|-0.9|0.49|||Mixed Models Analysis|||Walking ability||0.49|-0.90|.560
70956190|NCT01237587|141415925|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.371||0.448|TWO_SIDED|95.0|-1.01|0.45|||Mixed Models Analysis|||Normal Work||0.45|-1.01|0.448
70956191|NCT01237587|141415925|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.312||0.011|TWO_SIDED|95.0|-1.42|-0.19|||Mixed Models Analysis|||Relations With Other||-0.19|-1.42|.011
70956192|NCT01237587|141415925|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.454||0.443|TWO_SIDED|95.0|-1.25|0.55|||Mixed Models Analysis|||Sleep||0.55|-1.25|.443
70956193|NCT01237587|141415925|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.338||0.39|TWO_SIDED|95.0|-0.96|0.38|||Mixed Models Analysis|||Enjoyment of Life||0.38|-0.96|.390
71150272|NCT03847896|141793725|SUPERIORITY||Mean Difference (Final Values)|73.3||||0.037|TWO_SIDED|95.0|4.4|142.2|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||142.2|4.4|0.037
71150273|NCT03847896|141793725|SUPERIORITY||Mean Difference (Final Values)|99.9||||0.005|TWO_SIDED|95.0|30.9|168.8|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||168.8|30.9|0.005
71150274|NCT03847896|141793725|SUPERIORITY||Mean Difference (Final Values)|132.8|||<|0.001|TWO_SIDED|95.0|63.6|201.9|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||201.9|63.6|<0.001
71150275|NCT03847896|141793725|SUPERIORITY||Mean Difference (Final Values)|87.9||||0.013|TWO_SIDED|95.0|18.8|156.9|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||156.9|18.8|0.013
71150276|NCT03847896|141793725|SUPERIORITY||Mean Difference (Final Values)|120.8|||<|0.001|TWO_SIDED|95.0|51.5|190.1|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||190.1|51.5|<0.001
71150277|NCT03847896|141793726|SUPERIORITY||Median Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-6.0|1.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||1|-6|
71150278|NCT03847896|141793726|SUPERIORITY||Median Difference (Final Values)|3.0|||||TWO_SIDED|95.0|-3.0|9.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||9|-3|
70956194|NCT01237587|141415925|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.424||0.16|TWO_SIDED|95.0|-1.44|0.24|||Mixed Models Analysis|||School Work||0.24|-1.44|.160
71150279|NCT03847896|141793726|SUPERIORITY||Median Difference (Final Values)|-4.5|||||TWO_SIDED|95.0|-9.0|0.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||0|-9|
71150280|NCT03847896|141793726|SUPERIORITY||Median Difference (Final Values)|-4.5|||||TWO_SIDED|95.0|-9.0|0.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||0|-9|
70956195|NCT01237587|141415927|SUPERIORITY|||||||0.051|||||||Fisher Exact|||||||.051
71150281|NCT03847896|141793726|SUPERIORITY||Median Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-3.0|0.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||0|-3|
71150282|NCT03847896|141793726|SUPERIORITY||Median Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-2.0|0.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||0|-2|
71150283|NCT03847896|141793726|SUPERIORITY||Median Difference (Final Values)|-6.5|||||TWO_SIDED|95.0|-11.0|-2.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||-2|-11|
71150284|NCT03847896|141793726|SUPERIORITY||Median Difference (Final Values)|-6.5|||||TWO_SIDED|95.0|-11.0|-2.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||-2|-11|
71150285|NCT03847896|141793726|SUPERIORITY||Median Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-1.0|1.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||1|-1|
71150286|NCT03847896|141793728|SUPERIORITY||Odds Ratio (OR)|0.699||||0.118|TWO_SIDED|95.0|0.445|1.096|||Regression, Logistic|||Comparison is not type-I error controlled.||1.096|0.445|0.118
70956196|NCT01237587|141415928|SUPERIORITY|||||||0.038|||||||Fisher Exact|||||||.038
70956197|NCT01237587|141415929|SUPERIORITY||Mean Difference (Final Values)|1.62||||0.669|TWO_SIDED|95.0|-9.1|5.86|||ANCOVA|||Average Pain Score||5.86|-9.10|.669
70956198|NCT01237587|141415929|SUPERIORITY||Mean Difference (Final Values)|-5.9||||0.169|TWO_SIDED|95.0|-14.32|2.53|||ANCOVA|||Worst Pain Score||2.53|-14.32|.169
70956199|NCT01237587|141415929|SUPERIORITY||Mean Difference (Final Values)|-1.79||||0.647|TWO_SIDED|95.0|-9.53|5.94|||ANCOVA|||Pain Score Right Now||5.94|-9.53|.647
70956200|NCT01237587|141415930|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.146|TWO_SIDED|95.0|-0.52|0.08|||ANCOVA|||||0.08|-0.52|.146
70956201|NCT01237587|141415931|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.927|TWO_SIDED|95.0|-0.23|0.21|||ANCOVA|||||0.21|-0.23|.927
70956202|NCT01237587|141415932|SUPERIORITY||Mean Difference (Final Values)|1.03||||0.431|TWO_SIDED|95.0|-1.54|3.59|||ANCOVA|||||3.59|-1.54|.431
70956203|NCT01237587|141415933|SUPERIORITY||Mean Difference (Final Values)|0.92||||0.529|TWO_SIDED|95.0|-1.95|3.79|||ANCOVA|||||3.79|-1.95|.529
70956204|NCT01237587|141415934|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.335|TWO_SIDED|95.0|-2.52|0.86|||ANCOVA|||||0.86|-2.52|.335
70956205|NCT01237587|141415935|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.955|TWO_SIDED|95.0|-1.59|1.68|||ANCOVA|||Physical Symptoms Score||1.68|-1.59|.955
71150287|NCT03847896|141793728|SUPERIORITY||Odds Ratio (OR)|1.386||||0.161|TWO_SIDED|95.0|0.878|2.187|||Regression, Logistic|||Comparison is not type-I error controlled.||2.187|0.878|0.161
71150288|NCT03847896|141793728|SUPERIORITY||Odds Ratio (OR)|1.605||||0.044|TWO_SIDED|95.0|1.013|2.541|||Regression, Logistic|||Comparison is not type-I error controlled.||2.541|1.013|0.044
71150289|NCT03847896|141793728|SUPERIORITY||Odds Ratio (OR)|1.626||||0.039|TWO_SIDED|95.0|1.024|2.584|||Regression, Logistic|||Comparison is not type-I error controlled.||2.584|1.024|0.039
71150290|NCT03847896|141793728|SUPERIORITY||Odds Ratio (OR)|2.297|||<|0.001|TWO_SIDED|95.0|1.456|3.626|||Regression, Logistic|||Comparison is not type-I error controlled.||3.626|1.456|<0.001
71150291|NCT03847896|141793728|SUPERIORITY||Odds Ratio (OR)|2.328|||<|0.001|TWO_SIDED|95.0|1.471|3.687|||Regression, Logistic|||Comparison is not type-I error controlled.||3.687|1.471|<0.001
71150292|NCT03847896|141793728|SUPERIORITY||Odds Ratio (OR)|1.158||||0.532|TWO_SIDED|95.0|0.731|1.835|||Regression, Logistic|||Comparison is not type-I error controlled.||1.835|0.731|0.532
71150293|NCT03847896|141793728|SUPERIORITY||Odds Ratio (OR)|1.174||||0.499|TWO_SIDED|95.0|0.737|1.868|||Regression, Logistic|||Comparison is not type-I error controlled.||1.868|0.737|0.499
71150294|NCT03847896|141793728|SUPERIORITY||Odds Ratio (OR)|1.014||||0.955|TWO_SIDED|95.0|0.635|1.618|||Regression, Logistic|||Comparison is not type-I error controlled.||1.618|0.635|0.955
71150295|NCT03847896|141793729|SUPERIORITY||Mean Difference (Final Values)|-42.1||||0.169|TWO_SIDED|95.0|-101.9|17.8|||ANCOVA|||Comparison is not type-I error controlled.||17.8|-101.9|0.169
71150296|NCT03847896|141793729|SUPERIORITY||Mean Difference (Final Values)|52.1||||0.086|TWO_SIDED|95.0|-7.4|111.5|||ANCOVA|||Comparison is not type-I error controlled.||111.5|-7.4|0.086
71150297|NCT03847896|141793729|SUPERIORITY||Mean Difference (Final Values)|30.7||||0.31|TWO_SIDED|95.0|-28.6|90.1|||ANCOVA|||Comparison is not type-I error controlled.||90.1|-28.6|0.31
70875981|NCT02879305|141235910|SUPERIORITY||LS mean difference|0.24||||0.2392|TWO_SIDED|95.0|-0.43|0.92|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and model adjusted Week 28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.92|-0.43|0.2392
71150298|NCT03847896|141793729|SUPERIORITY||Mean Difference (Final Values)|65.9||||0.03|TWO_SIDED|95.0|6.3|125.4|||ANCOVA|||Comparison is not type-I error controlled.||125.4|6.3|0.03
71150299|NCT03847896|141793729|SUPERIORITY||Mean Difference (Final Values)|72.8||||0.017|TWO_SIDED|95.0|13.1|132.5|||ANCOVA|||Comparison is not type-I error controlled.||132.5|13.1|0.017
71150300|NCT03847896|141793729|SUPERIORITY||Mean Difference (Final Values)|107.9|||<|0.001|TWO_SIDED|95.0|48.1|167.8|||ANCOVA|||Comparison is not type-I error controlled.||167.8|48.1|<0.001
71150301|NCT03847896|141793729|SUPERIORITY||Mean Difference (Final Values)|-21.3||||0.48|TWO_SIDED|95.0|-80.5|37.9|||ANCOVA|||Comparison is not type-I error controlled.||37.9|-80.5|0.48
71150302|NCT03847896|141793729|SUPERIORITY||Mean Difference (Final Values)|13.8||||0.648|TWO_SIDED|95.0|-45.6|73.2|||ANCOVA|||Comparison is not type-I error controlled.||73.2|-45.6|0.648
71150303|NCT03847896|141793729|SUPERIORITY||Mean Difference (Final Values)|35.1||||0.246|TWO_SIDED|95.0|-24.2|94.5|||ANCOVA|||Comparison is not type-I error controlled.||94.5|-24.2|0.246
71150304|NCT00118417|141793730|SUPERIORITY_OR_OTHER|||||||0||95.0||||Paired t-test between endpoint and baseline PDSS|t-test, 2 sided|Degrees of Freedom = 38||||||0.0000
71150305|NCT00118417|141793731|SUPERIORITY_OR_OTHER|||||||0.97||95.0||||T-test of PDSS change score|t-test, 2 sided|Degrees of Freedom = 22||||||0.97
71150306|NCT00118417|141793732|SUPERIORITY_OR_OTHER|||||||0.061||95.0||||T-test of PDSS change between baseline and endpoint of Phase 3|t-test, 2 sided|Degrees of Freedom = 17||||||0.061
71150307|NCT02978781|141793734|SUPERIORITY||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.227||0.9143|TWO_SIDED|95.0|-0.44|0.49|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|Change from Randomization at Day 14 (predose)|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.49|-0.44|0.9143
71150308|NCT02978781|141793735|OTHER||Least Squares Mean Difference|-1.74|STANDARD_ERROR_OF_MEAN|0.815||0.0529|TWO_SIDED|95.0|-3.5|0.03|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.03|-3.50|0.0529
71150309|NCT02978781|141793741|SUPERIORITY||Least Squares Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|1.326||0.7795|TWO_SIDED|95.0|-3.47|2.7|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|Change from Randomization at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|2.70|-3.47|0.7795
71150310|NCT02978781|141793742|SUPERIORITY||Least Squares Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.473||0.4846|TWO_SIDED|95.0|-0.65|1.33|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|Change from Randomization in Forward outstretched postural tremor (FOPT) at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|1.33|-0.65|0.4846
71150311|NCT02978781|141793742|SUPERIORITY||Least Squares Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.845||0.4567|TWO_SIDED|95.0|-2.7|1.36|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|"Change from Randomization in Lateral wing beating postural tremor (LWBPT) at Day 14"|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|1.36|-2.70|0.4567
71150312|NCT02978781|141793743|SUPERIORITY||Least Squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.85||0.3771|TWO_SIDED|95.0|-2.48|0.96|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|Change from Randomization at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.96|-2.48|0.3771
70956206|NCT01237587|141415935|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.381|TWO_SIDED|95.0|-1.82|0.7|||ANCOVA|||Harm Avoidance||0.70|-1.82|.381
70875982|NCT02879305|141235910|SUPERIORITY||LS mean difference|-0.15||||0.6545|TWO_SIDED|95.0|-0.9|0.6|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and model adjusted Week 52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.60|-0.90|0.6545
70875983|NCT02879305|141235911|SUPERIORITY||LS mean difference|0.64||||0.029|TWO_SIDED|95.0|-0.02|1.31|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and model adjusted Week 8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.31|-0.02|0.0290
70875984|NCT02879305|141235911|SUPERIORITY||LS mean difference|0.56||||0.0509|TWO_SIDED|95.0|-0.11|1.24|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and model adjusted Week 12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.24|-0.11|0.0509
71150313|NCT02978781|141793744|SUPERIORITY||Least Squares Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.415||0.7302|TWO_SIDED|95.0|-0.97|0.69|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|Change from Randomization in Forward outstretched postural tremor (FOPT) at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.69|-0.97|0.7302
71150314|NCT02978781|141793744|SUPERIORITY||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.467||0.7916|TWO_SIDED|95.0|-1.1|0.85|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|"Change from Randomization in Lateral wing beating postural tremor (LWBPT) at Day 14"|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.85|-1.10|0.7916
71150315|NCT02978781|141793745|SUPERIORITY||Least Squares Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.34||0.1807|TWO_SIDED|95.0|-1.17|0.23|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|Change from Randomization at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.23|-1.17|0.1807
71150316|NCT02978781|141793746|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.72||0.8709|TWO_SIDED|95.0|-1.7|1.9|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline(SAGE-217 - placebo)|Change from Baseline in Archimedes Spirals (AS) at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|1.9|-1.7|0.8709
71150317|NCT02978781|141793746|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.65||0.7843|TWO_SIDED|95.0|-1.8|1.4|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217 - placebo)|Change from Baseline in Handwriting at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|1.4|-1.8|0.7843
71150318|NCT02978781|141793746|SUPERIORITY||Least Squares Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.984||0.7604|TWO_SIDED|95.0|-2.72|2.1|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217 - placebo|Change from Baseline in Dot approximation task (DAT) at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|2.10|-2.72|0.7604
71150319|NCT02978781|141793747|OTHER||Least Squares Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.301||0.1333|TWO_SIDED|95.0|-1.13|0.17|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Forward outstretched postural tremor (FOPT) at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.17|-1.13|0.1333
71150320|NCT02978781|141793747|OTHER||Least Squares Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.389||0.0572|TWO_SIDED|95.0|-1.64|0.03|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|"Change from Baseline in Lateral wing beating postural tremor (LWBPT) at Day 15"|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.03|-1.64|0.0572
71150321|NCT02978781|141793747|OTHER||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.255||0.0707|TWO_SIDED|95.0|-1.05|0.05|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Kinetic tremor (KT) at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.05|-1.05|0.0707
70956207|NCT01237587|141415935|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.486|TWO_SIDED|95.0|-1.66|0.79|||ANCOVA|||Social Anxiety||0.79|-1.66|.486
71150322|NCT02978781|141793748|OTHER||Least Squares Mean Difference|-1.53|STANDARD_ERROR_OF_MEAN|0.628||0.0278|TWO_SIDED|95.0|-2.87|-0.19|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|-0.19|-2.87|0.0278
71150323|NCT02978781|141793749|OTHER||Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.258||0.9579|TWO_SIDED|95.0|-0.57|0.54|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Forward outstretched postural tremor (FOPT) at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.54|-0.57|0.9579
71150324|NCT02978781|141793749|OTHER||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.234||0.0039|TWO_SIDED|95.0|-1.31|-0.3|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|"Change from Baseline in Lateral wing beating postural tremor (LWBPT) at Day 15"|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|-0.30|-1.31|0.0039
70875985|NCT02879305|141235911|SUPERIORITY||LS mean difference|0.77||||0.0237|TWO_SIDED|95.0|0.01|1.53|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and model adjusted Week 28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.53|0.01|0.0237
70875986|NCT02879305|141235911|SUPERIORITY||LS mean difference|0.58||||0.0828|TWO_SIDED|95.0|-0.24|1.39|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and model adjusted Week 52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.39|-0.24|0.0828
70875987|NCT02879305|141235912|SUPERIORITY||LS mean difference|0.0003||||0.4939|TWO_SIDED|95.0|-0.0326|0.0331|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.0331|-0.0326|0.4939
70875988|NCT02879305|141235913|SUPERIORITY||LS mean difference|-1.8||||0.9292|TWO_SIDED|95.0|-4.2|0.6|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.6|-4.2|0.9292
70875989|NCT02879305|141235914|SUPERIORITY||LS mean difference|-0.06||||0.0428|TWO_SIDED|95.0|-0.13|0.01|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and model adjusted Week 8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.01|-0.13|0.0428
70875990|NCT02879305|141235914|SUPERIORITY||LS mean difference|-0.04||||0.1155|TWO_SIDED|95.0|-0.11|0.03|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and model adjusted Week 12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.03|-0.11|0.1155
70875991|NCT02879305|141235914|SUPERIORITY||LS mean difference|-0.04||||0.1426|TWO_SIDED|95.0|-0.12|0.03|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and model adjusted Week 28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.03|-0.12|0.1426
70875992|NCT02879305|141235914|SUPERIORITY||LS mean difference|-0.05||||0.1152|TWO_SIDED|95.0|-0.13|0.03|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and model adjusted Week 52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.03|-0.13|0.1152
70875993|NCT03010254|141235984|SUPERIORITY||Least Squares Mean Difference|-0.138|STANDARD_ERROR_OF_MEAN|0.021|<|0.001|TWO_SIDED|95.0|-0.18|-0.097||2-sided p-value reported. A hypothesis test was based on a two sample t-test, with a type I error rate of 0.025, 1-sided.|t-test, 2 sided||Least squares mean difference (DFT015 - SN60WF)|||-0.097|-0.180|<0.001
70875994|NCT03010254|141235986|NON_INFERIORITY|Non-inferiority margin was 0.1 logMAR.|Least Squares Mean Difference|0.037|STANDARD_ERROR_OF_MEAN|0.0115|||ONE_SIDED|97.5||0.059|||||Least squares mean difference (DFT015 - SN60WF).The 1-sided 97.5% Upper Confidence Limit is presented.|||0.059||
70875995|NCT03010254|141235987|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.0216|<|0.001|TWO_SIDED|95.0|-0.133|-0.048||2-sided p-value reported. A hypothesis test was based on a two sample t-test, with a type I error rate of 0.025, 1-sided.|t-test, 2 sided||Least squares mean difference (DFT015 - SN60WF)|||-0.048|-0.133|<0.001
71150325|NCT02978781|141793749|OTHER||Least Squares Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.223||0.0099|TWO_SIDED|95.0|-1.14|-0.19|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Kinetic tremor (KT) at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|-0.19|-1.14|0.0099
70875996|NCT03010254|141235988|OTHER||Mean difference in depth of focus|0.52|||||TWO_SIDED|||||Hypothesis testing was not pre-specified.|||Mean difference in depth of focus (DFT015 - SN60WF)|||||
70875997|NCT03010254|141235989|NON_INFERIORITY|Non-inferiority margin was -0.15 log unit|Least Squares Mean Difference|-0.179|STANDARD_ERROR_OF_MEAN|0.0551|||ONE_SIDED|97.5|-0.287||||||Least squares mean difference (DFT015 - SN60WF). The 1-sided 97.5 Lower Limit Confidence Interval is presented.|Without glare|||-0.287|
70875998|NCT03010254|141235989|NON_INFERIORITY|Non-inferiority margin was -0.15 log unit|Least Squares Mean Difference|-0.181|STANDARD_ERROR_OF_MEAN|0.0541|||ONE_SIDED|97.5|-0.287||||||Least squares mean difference (DFT015 - SN60WF). The 1-sided 97.5 Lower Limit Confidence Interval is presented.|With glare|||-0.287|
70875999|NCT03010254|141235990|SUPERIORITY||Difference in percentage|20.2|||||TWO_SIDED|95.0|8.77|31.04|||||95% CI for the difference (DFT015 - SN60WF) is estimated using Miettinen-Nurminen method (1985).|||31.04|8.77|
70876000|NCT03010254|141235991|SUPERIORITY||Percent difference|21.7|||||TWO_SIDED|95.0|7.92|35.06|||||95% CI for the difference (DFT015 - SN60WF) is estimated using Miettinen-Nurminen method (1985).|||35.06|7.92|
70956208|NCT01237587|141415935|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.7|TWO_SIDED|95.0|-1.17|0.79|||ANCOVA|||Separation/Panic||0.79|-1.17|.700
70956209|NCT01237587|141415935|SUPERIORITY||Mean Difference (Final Values)|-1.21||||0.54|TWO_SIDED|95.0|-5.12|2.69|||ANCOVA|||Total Score||2.69|-5.12|.540
70956210|NCT02656329|141415944|NON_INFERIORITY|Non-inferiority of AdreView™ group over SoC group was demonstrated if upper bound of the 95% confidence interval (CI) for the hazard ratio (HR) (AdreView™ group / SoC) was equal to 1.20.|Hazard Ratio (HR)|1.047||||0.8459|TWO_SIDED|95.0|0.295|3.719||Threshold for significance at 0.025 level.|Log Rank||AdreView™ vs. Standard of Care|Analysis was performed using the Cox proportional hazards model stratified by country, with method of treatment guidance (SoC vs AdreView™ group) as the only covariate.||3.719|0.295|0.8459
70956211|NCT01139580|141415953|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
70956212|NCT01139580|141415956|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
71150326|NCT02978781|141793750|OTHER||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.41||0.1595|TWO_SIDED|95.0|-1.5|0.3|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Archimedes spirals (AS) at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.3|-1.5|0.1595
70956213|NCT00633880|141415967|SUPERIORITY_OR_OTHER|||||||0.509||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors. As the primary endpoint was not positive, statistical analysis was not performed on secondary endpoints.|Wilcoxon (Mann-Whitney)|||||||0.509
71150327|NCT02978781|141793750|OTHER||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0126|TWO_SIDED|95.0|-0.9|-0.1|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Handwriting at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|-0.1|-0.9|0.0126
71150328|NCT02978781|141793750|OTHER||Least Squares Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.151||0.1536|TWO_SIDED|95.0|-0.55|0.1|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Dot approximation task (DAT) at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.10|-0.55|0.1536
70956214|NCT00633880|141415972|SUPERIORITY_OR_OTHER|||||||0.026|||||||Wilcoxon (Mann-Whitney)|||||||0.026
70956215|NCT03748992|141415999|OTHER|Since no hypothesis testing was planned, no power analysis was required||||||||||||Non Applicable||Non Applicable||This was a single arm trial. there is no comparator group.|The overall response rates were calculated, and exact binomial confidence intervals was constructed.|||
70956216|NCT03748992|141416001|OTHER|Since no hypothesis testing was planned, no power analysis was required||||||||||||||||This was a single arm trial. there is no comparator group.|The overall response rates were calculated, and exact binomial confidence intervals was constructed.|||
70956217|NCT03924765|141416016|OTHER|A one-way repeated measures analysis of variance (ANOVA) was performed on different exoskeleton assistance strategies (including the baseline of not wearing the exoskeleton) on the subject's overground self-selected walking speed by setting an alpha value to 0.05.||||||5e-06|||||||ANOVA|||Primary Outcome Measure - Arm/Group 1||||0.000005
71150329|NCT00785785|141793759|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.466||||0.0081|TWO_SIDED|95.0|1.104|1.945|||Hazard Ratio|||||1.945|1.104|0.0081
71150330|NCT02453321|141793760|SUPERIORITY|||||||0.355|||||||Kruskal-Wallis|||||||0.355
71150331|NCT02453321|141793761|SUPERIORITY|||||||0.065|||||||Kruskal-Wallis|||||||0.065
71150332|NCT02282605|141793793|SUPERIORITY_OR_OTHER|||||||0.792|||||||Fisher Exact|||||||0.792
70956218|NCT03924765|141416017|OTHER|A one-way repeated measures analysis of variance (ANOVA) was performed on different exoskeleton assistance strategies (including the baseline of not wearing the exoskeleton) on the subject's step length asymmetry by setting an alpha value to 0.05.||||||0.131|||||||ANOVA|||Secondary Outcome Measure - Arm/Group 1||||0.131
70956219|NCT04548544|141416026|OTHER|||||||0.38|||||||ANOVA|||timepoint × group interaction|timepoint × group interaction F = 0.77, p = 0.38|||0.38
70956220|NCT05172050|141416027|SUPERIORITY|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.|Odds Ratio (OR)|9.99||||0.0109|TWO_SIDED|95.0|1.781||Upper limit is not estimable (NE) due to the low number of events||Regression, Logistic||||||1.781|0.0109
70956221|NCT05172050|141416027|SUPERIORITY|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.|Odds Ratio (OR)|5.414||||0.0673|TWO_SIDED|95.0|0.858||The upper limit is not estimable (NE), due to the low number of events||Regression, Logistic||||||0.858|0.0673
70956222|NCT05172050|141416027|SUPERIORITY||Odds Ratio (OR)|12.186||||0.0061|TWO_SIDED|95.0|2.147||The upper limit was not estimable due to the low number of events|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.|Regression, Logistic|||This sensitivity analysis is conducted on the per protocol (PP) population: n=18 in the Raloxifene 60 mg arm; n=17 in the Raloxifene 120 mg arm; and n=17 in the Placebo arm.|||2.147|0.0061
70956223|NCT05172050|141416027|SUPERIORITY||Odds Ratio (OR)|5.936||||0.0567|TWO_SIDED|95.0|0.938||The upper limit was not estimable due to the low number of events|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.|Regression, Logistic|||This sensitivity analysis is conducted on the per protocol (PP) population: n=18 in the Raloxifene 60 mg arm; n=17 in the Raloxifene 120 mg arm; and n=17 in the Placebo arm|||0.938|0.0567
70956224|NCT05172050|141416028|SUPERIORITY|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects|Odds Ratio (OR)|1.663||||0.7121|TWO_SIDED|95.0|0.337|9.053|||Regression, Logistic|||||9.053|0.337|0.7121
70876001|NCT01404325|141235992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70876002|NCT02144233|141236021|SUPERIORITY|||||||0.54|||||||Mixed Models Analysis|||||||0.54
70876003|NCT02068443|141236070|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.087|||TWO_SIDED|95.0|-0.821|-0.48|||||Estimated Value was for the difference between Alogliptin + Metformin Hydrochloride QD and Alogliptin alone (Metformin QD - Alogliptin alone).|||-0.480|-0.821|
70876004|NCT02068443|141236070|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority of Alogliptin + Metformin Hydrochloride QD to Alogliptin + Metformin Hydrochloride BID.|LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.069|||TWO_SIDED|95.0|-0.026|0.247|||||Estimated Value was for the difference between Alogliptin + Metformin Hydrochloride QD and Alogliptin + Metformin Hydrochloride BID (Metformin QD - Metformin BID).|||0.247|-0.026|
70876005|NCT01986855|141236080|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.03||||0.807|TWO_SIDED|95.0|-0.23|0.18||The cLDA model included fixed effects for treatment, time, eGFR stratum (\<45 or ≥45 mL/min/1.73m\^2), baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||0.18|-0.23|0.807
71150333|NCT02282605|141793793|SUPERIORITY_OR_OTHER|||||||0.887|||||||Fisher Exact|||||||0.887
71150334|NCT02282605|141793794|SUPERIORITY_OR_OTHER|||||||0.0058||||||For timepoint Day 3 (12 hours after last dose)|Fisher Exact|||||||0.0058
71150335|NCT02282605|141793796|SUPERIORITY_OR_OTHER|||||||0.028||||||The adjusted means were compared for the two-day treatment period.|ANCOVA|||||||0.028
71150336|NCT02282605|141793796|SUPERIORITY_OR_OTHER||||||<|0.001||||||The adjusted means were compared for the two-day treatment period to discharge.|ANCOVA|||||||<0.001
71150337|NCT02282605|141793796|SUPERIORITY_OR_OTHER|||||||0.005||||||The adjusted means were compared for the two-day treatment period through to discharge|ANCOVA|||||||0.005
71150338|NCT02350296|141793802|EQUIVALENCE|Acceptance criterion for bioequivalence was a 94.12% confidence interval for the test/reference ratio of the geometric means within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies.|geometric means ratio|108.12||||0.1455|TWO_SIDED|94.12|97.57|119.81||"treatment P value reported"|ANOVA||Estimated value and limits are expressed in %|||119.81|97.57|0.1455
71150339|NCT02350296|141793803|EQUIVALENCE|Acceptance criterion for bioequivalence was a 94.12% confidence interval for the test/reference ratio of the geometric means within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies.|geometric means ratio|110.62||||0.0023|TWO_SIDED|94.12|104.26|117.38||"Treatment P value is reported"|ANOVA||Estimated value and limits are expressed in %|||117.38|104.26|0.0023
70876006|NCT01986855|141236080|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.15||||0.155|TWO_SIDED|95.0|-0.35|0.06||The cLDA model included fixed effects for treatment, time, eGFR stratum (\<45 or ≥45 mL/min/1.73m\^2), baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||0.06|-0.35|0.155
70876007|NCT01986855|141236081|SUPERIORITY_OR_OTHER||Difference in Percentages vs. Placebo|3.6|||||TWO_SIDED|95.0|-4.8|12.1|||||Miettinen \& Nurminen Method|||12.1|-4.8|
70876008|NCT01986855|141236081|SUPERIORITY_OR_OTHER||Difference in Percentages vs. Placebo|-7.0|||||TWO_SIDED|95.0|-16.3|2.3|||||Miettinen \& Nurminen Method|||2.3|-16.3|
70876009|NCT01986855|141236082|SUPERIORITY_OR_OTHER||Difference in Percentages vs. Placebo|3.0|||||TWO_SIDED|95.0|-2.7|9.0|||||Miettinen \& Nurminen Method|||9.0|-2.7|
70876010|NCT01986855|141236082|SUPERIORITY_OR_OTHER||Difference in Percentages vs. Placebo|-1.3|||||TWO_SIDED|95.0|-6.5|3.7|||||Miettinen \& Nurminen Method|||3.7|-6.5|
70876011|NCT01986855|141236083|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.03||||0.828|TWO_SIDED|95.0|-0.28|0.23||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||0.23|-0.28|0.828
70876012|NCT01986855|141236083|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.09||||0.496|TWO_SIDED|95.0|-0.35|0.17||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||0.17|-0.35|0.496
70876013|NCT01986855|141236084|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.77|||<|0.001|TWO_SIDED|95.0|-2.57|-0.96||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable. P-value is nominal.|Constrained longitudinal data analysis|||||-0.96|-2.57|<0.001
70876014|NCT01986855|141236084|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.84|||<|0.001|TWO_SIDED|95.0|-2.66|-1.02||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable. P-value is nominal.|Constrained longitudinal data analysis|||||-1.02|-2.66|<0.001
71150340|NCT02350296|141793804|EQUIVALENCE|Acceptance criterion for bioequivalence was a 94.12% confidence interval for the test/reference ratio of the geometric means within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies.|geometric means ratio|110.69||||0.0021|TWO_SIDED|94.12|104.35|117.41||"treatment P value is reported"|ANOVA||Estimated value and limits are expressed in %|||117.41|104.35|0.0021
71150341|NCT02350296|141793805|EQUIVALENCE|Acceptance criterion for bioequivalence was a 94.12% confidence interval for the test/reference ratio of the geometric means within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies.||||||0.0201|||||||Friedman|||||||0.0201
71150342|NCT01544335|141793816|OTHER||||||<|0.001|||||||Correlation coefficient|The correlation between RVC and ΔL-Dex values was plotted, and the correlation strength was assessed using the Pearson correlation coefficient, r.||||||<0.001
71150343|NCT01532986|141793825|SUPERIORITY||Mean Difference (Final Values)|0.189|||>|0.05|TWO_SIDED|95.0|0.157|0.222|||t-test, 2 sided|||||0.222|0.157|>0.05
71150344|NCT01532986|141793826|SUPERIORITY||Mean Difference (Final Values)|0.02|||>|0.05|TWO_SIDED|95.0|-0.04|0.08|||t-test, 2 sided|||||0.08|-0.04|>0.05
71150345|NCT01532986|141793827|SUPERIORITY||Mean Difference (Final Values)|0.02|||>|0.05|TWO_SIDED|95.0|-0.52|0.57|||t-test, 2 sided|||||0.57|-0.52|>0.05
71150346|NCT01532986|141793828|SUPERIORITY||Mean Difference (Final Values)|-0.12|||>|0.05|TWO_SIDED|95.0|-0.34|0.1|||t-test, 2 sided|||||0.10|-0.34|>0.05
71150347|NCT01532986|141793829|SUPERIORITY||Mean Difference (Final Values)|-0.88|||>|0.05|TWO_SIDED|95.0|-2.04|0.29|||t-test, 2 sided|||||0.29|-2.04|>0.05
71150348|NCT01532986|141793830|SUPERIORITY||Mean Difference (Final Values)|1.22|||>|0.05|TWO_SIDED|95.0|-8.02|10.46|||t-test, 2 sided|||||10.46|-8.02|>0.05
71150349|NCT01532986|141793831|SUPERIORITY||Mean Difference (Final Values)|0.17|||>|0.05|TWO_SIDED|95.0|0.0|0.34|||t-test, 2 sided|||||0.34|0.00|>0.05
71150350|NCT01532986|141793832|SUPERIORITY||Mean Difference (Final Values)|-0.06|||>|0.05|TWO_SIDED|95.0|-1.45|1.33|||t-test, 2 sided|||||1.33|-1.45|>0.05
71150351|NCT01532986|141793833|SUPERIORITY||Mean Difference (Final Values)|-11.52|||<|0.05|TWO_SIDED|95.0|-20.42|-2.62|||t-test, 2 sided|||||-2.62|-20.42|<0.05
71150352|NCT01532986|141793834|SUPERIORITY||Mean Difference (Final Values)|-1.98|||>|0.05|TWO_SIDED|95.0|-4.2|0.24|||t-test, 2 sided|||||0.24|-4.20|>0.05
71150353|NCT04614974|141793835|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
71150354|NCT04614974|141793836|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
71150355|NCT04614974|141793837|OTHER|||||||0.5|||||||McNemar|||Noisy breathing pre/post||||0.5
71150356|NCT04614974|141793837|OTHER|||||||0.01|||||||McNemar|||Noisy breathing pre/post||||0.01
71150357|NCT04614974|141793837|OTHER|||||||0.2|||||||McNemar|||Stridor pre/post||||0.2
71150358|NCT04614974|141793837|SUPERIORITY|||||||0.02|||||||McNemar|||Stridor pre/post||||0.02
71150359|NCT04614974|141793837|OTHER|||||||0.5|||||||McNemar|||Chest wall retractions pre/post||||0.5
71150360|NCT04614974|141793837|OTHER|||||||1|||||||McNemar|||Chest wall retractions pre/post||||1.0
71150361|NCT04614974|141793837|OTHER|||||||1|||||||McNemar|||Apnea pre/post||||1.0
71150362|NCT04614974|141793838|OTHER|||||||0.5|||||||McNemar|||Emesis pre/post||||0.5
71150363|NCT04614974|141793838|OTHER|||||||0.07|||||||McNemar|||Emesis pre/post||||0.07
71150364|NCT04614974|141793838|SUPERIORITY|||||||0.06|||||||McNemar|||Choking pre/post||||0.06
71150365|NCT04614974|141793838|OTHER|||||||1|||||||McNemar|||Choking pre/post||||1.0
71150366|NCT04614974|141793838|OTHER|||||||0.02|||||||McNemar|||Coughing pre/post||||0.02
71150367|NCT04614974|141793838|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||Coughing pre/post||||1.0
71150368|NCT04614974|141793838|OTHER|||||||1|||||||McNemar|||Gagging pre/post||||1.0
71150369|NCT04614974|141793839|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
71150370|NCT04614974|141793840|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71150371|NCT00658359|141793847|SUPERIORITY_OR_OTHER||Estimated rate difference|2.19|STANDARD_ERROR_OF_MEAN|5.12||0.6694|TWO_SIDED|60.0|-2.12|6.5|||Wald Test||Tofacitinib LI minus CsA. Standard error of the mean refers to standard error of the estimated rate difference|Month 15||6.50|-2.12|0.6694
71150372|NCT00658359|141793847|SUPERIORITY_OR_OTHER||Estimated rate difference|10.71|STANDARD_ERROR_OF_MEAN|6.26||0.0873|TWO_SIDED|60.0|5.44|15.98|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 15||15.98|5.44|0.0873
71150373|NCT00658359|141793847|SUPERIORITY_OR_OTHER||Estimated rate difference|3.93|STANDARD_ERROR_OF_MEAN|5.71||0.4912|TWO_SIDED|60.0|-0.87|8.74|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18||8.74|-0.87|0.4912
71150374|NCT00658359|141793847|SUPERIORITY_OR_OTHER||Estimated rate difference|11.06|STANDARD_ERROR_OF_MEAN|6.61||0.0942|TWO_SIDED|60.0|5.5|16.62|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18||16.62|5.50|0.0942
70876015|NCT01986855|141236085|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.42||||0.451|TWO_SIDED|95.0|-5.13|2.29||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||2.29|-5.13|0.451
70876016|NCT01986855|141236085|SUPERIORITY_OR_OTHER||Difference in the least squares means|-3.46||||0.072|TWO_SIDED|95.0|-7.24|0.31||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||0.31|-7.24|0.072
70876017|NCT01986855|141236086|SUPERIORITY_OR_OTHER||Difference in the least squares means|-6.81||||0.291|TWO_SIDED|96.0|-19.47|5.85||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||5.85|-19.47|0.291
70876018|NCT01986855|141236086|SUPERIORITY_OR_OTHER||Difference in the least squares means|-15.51||||0.019|TWO_SIDED|95.0|-28.5|-2.53||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable. P-value is nominal.|Constrained longitudinal data analysis|||||-2.53|-28.50|0.019
70876019|NCT01986855|141236087|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.16||||0.713|TWO_SIDED|95.0|0.53|2.56||Adjusted Odds Ratio based on a logistic regression model fitted with fixed effects for treatment, baseline treatment with insulin stratum (yes/no), and a covariate for baseline A1C.|Logistic regression model|||||2.56|0.53|0.713
70876020|NCT01986855|141236087|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.06||||0.89|TWO_SIDED|95.0|0.44|2.55||Adjusted Odds Ratio based on a logistic regression model fitted with fixed effects for treatment, baseline treatment with insulin stratum (yes/no), and a covariate for baseline A1C.|Logistic regression model|||||2.55|0.44|0.890
70876021|NCT02771990|141236096|OTHER|Pilot study|z-score|3.11||||0.002|TWO_SIDED||||||Regression, Linear|||||||0.002
71150375|NCT00658359|141793847|SUPERIORITY_OR_OTHER||Estimated rate difference|7.31|STANDARD_ERROR_OF_MEAN|6.36||0.2499|TWO_SIDED|60.0|1.96|12.66|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24||12.66|1.96|0.2499
71150376|NCT00658359|141793847|SUPERIORITY_OR_OTHER||Estimated rate difference|13.47|STANDARD_ERROR_OF_MEAN|7.1||0.058|TWO_SIDED|60.0|7.49|19.45|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24||19.45|7.49|0.0580
70876022|NCT02771990|141236097|OTHER|Pilot study||||||0.67|||||||Regression, Linear|||||||0.67
70876023|NCT00848081|141236098|SUPERIORITY_OR_OTHER|||||||0.403||||||1-sided test|Fisher Exact|||The p-value is from a one-sided Fisher's exact test with a significance level of 0.05. A total of 142 subjects per treatment arm would provide 91% power to detect the difference between a Group 1 proportion of 0.03 and a Group 2 proportion of 0.13.||||0.403
70876024|NCT00848081|141236100|SUPERIORITY_OR_OTHER|||||||0.13||||||p-value is on change from baseline|ANCOVA|||The LS mean, standard error, 2-sided 95% confidence interval and p-value for the difference between placebo and tadalafil 5 mg are from an analysis of covariance (ANCOVA) model.||||0.130
70876025|NCT00848081|141236101|SUPERIORITY_OR_OTHER|||||||0.258||||||p-value is on change from baseline|ANOVA|The p-value is from Type III sums of squares ANOVA on rank-transformed data.||||||0.258
70876026|NCT00848081|141236102|SUPERIORITY_OR_OTHER|||||||0.828|||||||ANOVA|P-value is from Type III sums of squares ANOVA on rank-transformed data; p-value is on change from baseline.||||||0.828
70876027|NCT02064868|141236103|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0172|TWO_SIDED|95.0|0.51|0.98||One-sided p-value|Gehan's generalized Wilcoxon test|||||0.98|0.51|0.0172
70876028|NCT02064868|141236104|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.0634|TWO_SIDED|95.0|0.61|1.02||Two-sided p-value|Gehan's generalized Wilcoxon test|||||1.02|0.61|0.0634
70876029|NCT02064868|141236105|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
70876030|NCT02064868|141236106|SUPERIORITY|||||||0.0002|||||||Chi-squared|||||||0.0002
70876031|NCT02064868|141236107|SUPERIORITY|||||||0.1392|||||||Wilcoxon (Mann-Whitney)|||||||0.1392
70876032|NCT02064868|141236109|SUPERIORITY|||||||0.3115|||||||Mixed Models Analysis|||Day 5||||0.3115
70876033|NCT02064868|141236109|SUPERIORITY|||||||0.1236|||||||Mixed Models Analysis|||Day 14||||0.1236
70876034|NCT00711711|141236110|SUPERIORITY_OR_OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||All outcomes and control variables were compared between the treatment and the control group at each time point using the Wilcoxon rank-sum test or the chi-square test, as appropriate. The change in swelling from second day to seventh day, that is, during the treatment period, was compared using the Wilcoxon signed-rank test. The significance level was set at P\<.05.||||0.51
70876035|NCT00711711|141236111|SUPERIORITY_OR_OTHER|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||All outcomes and control variables were compared between the treatment and the control group at each time point using the Wilcoxon rank-sum test or the chi-square test, as appropriate. The change in swelling from second day to seventh day, that is, during the treatment period, was compared using the Wilcoxon signed-rank test. The significance level was set at P\<.05.||||0.58
70956225|NCT05172050|141416028|SUPERIORITY|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects|Odds Ratio (OR)|0.963|||>|0.999|TWO_SIDED|95.0|0.185|4.977|||Regression, Logistic|||||4.977|0.185|>0.999
71150377|NCT00658359|141793847|SUPERIORITY_OR_OTHER||Estimated rate difference|12.62|STANDARD_ERROR_OF_MEAN|7.09||0.075|TWO_SIDED|60.0|6.66|18.59|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30||18.59|6.66|0.0750
71150378|NCT00658359|141793847|SUPERIORITY_OR_OTHER||Estimated rate difference|16.66|STANDARD_ERROR_OF_MEAN|7.75||0.0316|TWO_SIDED|60.0|10.14|23.19|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30||23.19|10.14|0.0316
71150379|NCT00658359|141793847|SUPERIORITY_OR_OTHER||Estimated rate difference|13.21|STANDARD_ERROR_OF_MEAN|7.5||0.0783|TWO_SIDED|60.0|6.9|19.53|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36||19.53|6.90|0.0783
71150380|NCT00658359|141793847|SUPERIORITY_OR_OTHER||Estimated rate difference|20.27|STANDARD_ERROR_OF_MEAN|9.14||0.0266|TWO_SIDED|60.0|12.58|27.96|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36||27.96|12.58|0.0266
71150381|NCT00658359|141793847|SUPERIORITY_OR_OTHER||Estimated rate difference|13.21|STANDARD_ERROR_OF_MEAN|7.5||0.0783|TWO_SIDED|60.0|6.9|19.53|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42||19.53|6.90|0.0783
70876036|NCT00754624|141236131|SUPERIORITY_OR_OTHER||Slope|-0.048|||||TWO_SIDED|95.0|-0.059|-0.037|||Random coefficient|Adjusted for Baseline FEV1 value||A random coefficient model with a random intercept and slope associated with each subject, was fitted (using the PROC MIXED procedure in SAS) to the observed FEV1 data to estimate the annual rate of decline. The model included terms for baseline FEV1 and time (in years) of FEV1 measurements. Missing pulmonary functions were not imputed.||-0.037|-0.059|
71150382|NCT00658359|141793847|SUPERIORITY_OR_OTHER||Estimated rate difference|20.27|STANDARD_ERROR_OF_MEAN|9.14||0.0266|TWO_SIDED|60.0|12.58|27.96|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42||27.96|12.58|0.0266
71150383|NCT00658359|141793847|SUPERIORITY_OR_OTHER||Estimated rate difference|11.02|STANDARD_ERROR_OF_MEAN|7.74||0.1545|TWO_SIDED|60.0|4.51|17.54|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48||17.54|4.51|0.1545
71150384|NCT00658359|141793847|SUPERIORITY_OR_OTHER||Estimated rate difference|18.08|STANDARD_ERROR_OF_MEAN|9.34||0.0528|TWO_SIDED|60.0|10.22|25.94|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48||25.94|10.22|0.0528
71150385|NCT00658359|141793847|SUPERIORITY_OR_OTHER||Estimated rate difference|14.03|STANDARD_ERROR_OF_MEAN|8.45||0.0968|TWO_SIDED|60.0|6.92|21.14|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54||21.14|6.92|0.0968
71150386|NCT00658359|141793847|SUPERIORITY_OR_OTHER||Estimated rate difference|15.83|STANDARD_ERROR_OF_MEAN|9.53||0.0966|TWO_SIDED|60.0|7.81|23.85|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54||23.85|7.81|0.0966
70876037|NCT00754624|141236132|SUPERIORITY_OR_OTHER||Slope|-0.058|||||TWO_SIDED|95.0|-0.072|-0.043|||Random Coefficient|Adjusted for Baseline FVC value||A random coefficient model with a random intercept and slope associated with each subject, was fitted (using the PROC MIXED procedure in SAS) to the observed FVC data to estimate the annual rate of decline. The model included terms for baseline FVC and time (in years) of FVC measurements. Missing pulmonary functions were not imputed.||-0.043|-0.072|
70876038|NCT00754624|141236133|SUPERIORITY_OR_OTHER||Slope|-0.311|||||TWO_SIDED|95.0|-0.454|-0.168|||Random Coefficient|Adjusted for Baseline DLCo value||A random coefficient model with a random intercept and slope associated with each subject, was fitted (using the PROC MIXED procedure in SAS) to the observed DLco data to estimate the annual rate of decline. The model included terms for baseline DLco and time (in years) of DLco measurements. Missing pulmonary functions were not imputed.||-0.168|-0.454|
70876039|NCT00710710|141236141|OTHER||Maximum likelihood estimation|0.0233||||0.7021|TWO_SIDED|95.0|0.0006|0.1229||p0 = 0.056, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.1229|0.0006|0.7021
70876040|NCT00710710|141236141|OTHER||Maximum likelihood estimation|0.0233||||0.9156|TWO_SIDED|95.0|0.0006|0.1229||p0 = 0.092, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.1229|0.0006|0.9156
70876041|NCT00710710|141236141|OTHER||Maximum likelihood estimation|0.0233||||0.7021|TWO_SIDED|95.0|0.0006|0.1229||p0 = 0.056, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.1229|0.0006|0.7021
70876042|NCT00710710|141236141|OTHER||Maximum likelihood estimation|0.0233||||0.9156|TWO_SIDED|95.0|0.0006|0.1229||p0 = 0.092, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.1229|0.0006|0.9156
70876043|NCT00710710|141236144|OTHER||Hazard Ratio (HR)|1.22||||0.38|TWO_SIDED|95.0|0.78|1.91|||Regression, Cox||if HR is below 1, then 60mg BI 2536 IV on day 1-3 is better.|||1.91|0.78|0.38
70876044|NCT00710710|141236145|OTHER||Hazard Ratio (HR)|1.1||||0.69|TWO_SIDED|95.0|0.68|1.78|||Regression, Cox||if HR is below 1, then 60mg BI 2536 IV on day 1-3 is better.|||1.78|0.68|0.69
70876045|NCT00710710|141236146|OTHER||Maximum likelihood estimation|0.0||||0.9161|TWO_SIDED|95.0|0.0|0.0822||p0 = 0.056, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.0822|0.0000|0.9161
70876046|NCT00710710|141236146|OTHER||Maximum likelihood estimation|0.0||||0.9842|TWO_SIDED|95.0|0.0|0.0822||p0 = 0.092, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.0822|0.0000|0.9842
70876047|NCT00710710|141236146|OTHER||Maximum likelihood estimation|0.0||||0.9161|TWO_SIDED|95.0|0.0|0.0822||p0 = 0.056, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.0822|0.0000|0.9161
70876048|NCT00710710|141236146|OTHER||Maximum likelihood estimation|0.0||||0.9842|TWO_SIDED|95.0|0.0|0.0822||p0 = 0.092, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.0822|0.0000|0.9842
71150387|NCT00658359|141793847|SUPERIORITY_OR_OTHER||Estimated rate difference|17.07|STANDARD_ERROR_OF_MEAN|8.74||0.0507|TWO_SIDED|60.0|9.72|24.42|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60||24.42|9.72|0.0507
71150388|NCT00658359|141793847|SUPERIORITY_OR_OTHER||Estimated rate difference|15.83|STANDARD_ERROR_OF_MEAN|9.53||0.0966|TWO_SIDED|60.0|7.81|23.85|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60||23.85|7.81|0.0966
71150389|NCT00658359|141793847|SUPERIORITY_OR_OTHER||Estimated rate difference|17.07|STANDARD_ERROR_OF_MEAN|8.74||0.0507|TWO_SIDED|60.0|9.72|24.42|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66||24.42|9.72|0.0507
71150390|NCT00658359|141793847|SUPERIORITY_OR_OTHER||Estimated rate difference|15.83|STANDARD_ERROR_OF_MEAN|9.53||0.0966|TWO_SIDED|60.0|7.81|23.85|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66||23.85|7.81|0.0966
71150391|NCT00658359|141793847|SUPERIORITY_OR_OTHER||Estimated rate difference|18.17|STANDARD_ERROR_OF_MEAN|9.56||0.0574|TWO_SIDED|60.0|10.12|26.22|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72||26.22|10.12|0.0574
71150392|NCT00658359|141793847|SUPERIORITY_OR_OTHER||Estimated rate difference|21.08|STANDARD_ERROR_OF_MEAN|11.84||0.0749|TWO_SIDED|60.0|11.12|31.04|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72||31.04|11.12|0.0749
71150393|NCT00658359|141793847|SUPERIORITY_OR_OTHER||Estimated rate difference|3.65|STANDARD_ERROR_OF_MEAN|4.44||0.4116|TWO_SIDED|60.0|-0.09|7.38|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12||7.38|-0.09|0.4116
71150394|NCT00658359|141793847|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.98|STANDARD_ERROR_OF_MEAN|3.69||0.7895|TWO_SIDED|60.0|-4.09|2.12|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12||2.12|-4.09|0.7895
71150395|NCT00658359|141793848|SUPERIORITY_OR_OTHER||Estimated rate difference|2.4|STANDARD_ERROR_OF_MEAN|5.9||0.683|TWO_SIDED|95.0|-9.1|13.9|||Chi-squared||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|||13.9|-9.1|0.683
71150396|NCT00658359|141793848|SUPERIORITY_OR_OTHER||Estimated rate difference|3.9|STANDARD_ERROR_OF_MEAN|6.2||0.529|TWO_SIDED|95.0|-8.3|16.1|||Chi-squared||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|||16.1|-8.3|0.529
71150397|NCT00658359|141793849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.23|STANDARD_ERROR_OF_MEAN|5.04||0.0699|TWO_SIDED|60.0|4.97|13.49|||Mixed Models Analysis||Tofacitinib LI minus CsA|||13.49|4.97|0.0699
71150398|NCT00658359|141793849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.23|STANDARD_ERROR_OF_MEAN|6.32||0.1958|TWO_SIDED|60.0|2.89|13.58|||Mixed Models Analysis||Tofacitinib MI minus CsA|||13.58|2.89|0.1958
71150399|NCT00658359|141793851|SUPERIORITY_OR_OTHER||Estimated rate difference|2.19|STANDARD_ERROR_OF_MEAN|5.12||0.6694|TWO_SIDED|60.0|-2.12|6.5|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 15||6.50|-2.12|0.6694
71150400|NCT00658359|141793851|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.41|STANDARD_ERROR_OF_MEAN|4.89||0.934|TWO_SIDED|60.0|-4.52|3.71|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 15||3.71|-4.52|0.9340
71150401|NCT00658359|141793851|SUPERIORITY_OR_OTHER||Estimated rate difference|0.6|STANDARD_ERROR_OF_MEAN|5.32||0.9106|TWO_SIDED|60.0|-3.88|5.08|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18||5.08|-3.88|0.9106
71150402|NCT00658359|141793851|SUPERIORITY_OR_OTHER||Estimated rate difference|-1.99|STANDARD_ERROR_OF_MEAN|5.1||0.696|TWO_SIDED|60.0|-6.29|2.3|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18||2.30|-6.29|0.6960
71150403|NCT00658359|141793851|SUPERIORITY_OR_OTHER||Estimated rate difference|0.6|STANDARD_ERROR_OF_MEAN|5.32||0.9106|TWO_SIDED|60.0|-3.88|5.08|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24||5.08|-3.88|0.9106
71150404|NCT00658359|141793851|SUPERIORITY_OR_OTHER||Estimated rate difference|-1.99|STANDARD_ERROR_OF_MEAN|5.1||0.696|TWO_SIDED|60.0|-6.29|2.3|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24||2.30|-6.29|0.6960
71150405|NCT00658359|141793851|SUPERIORITY_OR_OTHER||Estimated rate difference|0.6|STANDARD_ERROR_OF_MEAN|5.32||0.9106|TWO_SIDED|60.0|-3.88|5.08|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30||5.08|-3.88|0.9106
71150406|NCT00658359|141793851|SUPERIORITY_OR_OTHER||Estimated rate difference|-1.99|STANDARD_ERROR_OF_MEAN|5.1||0.696|TWO_SIDED|60.0|-6.29|2.3|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30||2.30|-6.29|0.6960
71150407|NCT00658359|141793851|SUPERIORITY_OR_OTHER||Estimated rate difference|-1.18|STANDARD_ERROR_OF_MEAN|5.56||0.8322|TWO_SIDED|60.0|-5.86|3.5|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36||3.50|-5.86|0.8322
71150408|NCT00658359|141793851|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.77|STANDARD_ERROR_OF_MEAN|5.35||0.4809|TWO_SIDED|60.0|-8.27|0.73|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36||0.73|-8.27|0.4809
71150409|NCT00658359|141793851|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.34|STANDARD_ERROR_OF_MEAN|5.89||0.5704|TWO_SIDED|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42||1.62|-8.31|0.5704
71150410|NCT00658359|141793851|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.94|STANDARD_ERROR_OF_MEAN|5.7||0.2972|TWO_SIDED|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42||-1.14|-10.73|0.2972
71150411|NCT00658359|141793851|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.34|STANDARD_ERROR_OF_MEAN|5.89||0.5704|TWO_SIDED|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48||1.62|-8.31|0.5704
71150412|NCT00658359|141793851|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.94|STANDARD_ERROR_OF_MEAN|5.7||0.2972|TWO_SIDED|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48||-1.14|-10.73|0.2972
71150413|NCT00658359|141793851|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.34|STANDARD_ERROR_OF_MEAN|5.89||0.5704|TWO_SIDED|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54||1.62|-8.31|0.5704
70876049|NCT00715078|141236153|NON_INFERIORITY_OR_EQUIVALENCE|Cohort B is considered non-inferior to Cohort A if the lower limit of the 90% confidence interval (CI) for the ratio of Cohort B vs. Cohort A in the geometric mean of cumulative CD54 upregulation ratio is \>0.8. The use of one-sided CI is based on an assumption that a higher concentration will correspond to a higher CD54 upregulation ratio. The use of 0.8 as margin is based on the assumption that a relative difference of \<20% in upregulation ratios may not be clinically significant.|ratio of geometric means (GeoMean)|1.046||||0.5019|TWO_SIDED|90.0|0.936|1.168|||ANOVA|||The sample size determination is based on a standard deviation of 0.45 for the log transformed CD54 upregulation ratio estimated from previous studies assuming there is no difference in central values between the two compared cohorts. A sample size of 38 subjects per cohort will provide 70% power for the non-inferiority test for the two pairwise comparisons (Cohort B vs. Cohort A and Cohort C vs. Cohort A).||1.168|0.936|0.5019
71150414|NCT00658359|141793851|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.94|STANDARD_ERROR_OF_MEAN|5.7||0.2972|TWO_SIDED|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54||-1.14|-10.73|0.2972
71150415|NCT00658359|141793851|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.34|STANDARD_ERROR_OF_MEAN|5.89||0.5704|TWO_SIDED|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60||1.62|-8.31|0.5704
71150416|NCT00658359|141793851|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.94|STANDARD_ERROR_OF_MEAN|5.7||0.2972|TWO_SIDED|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60||-1.14|-10.73|0.2972
71150417|NCT00658359|141793851|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.34|STANDARD_ERROR_OF_MEAN|5.89||0.5704|TWO_SIDED|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66||1.62|-8.31|0.5704
71150418|NCT00658359|141793851|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.94|STANDARD_ERROR_OF_MEAN|5.7||0.2972|TWO_SIDED|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66||-1.14|-10.73|0.2972
71150419|NCT00658359|141793851|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.34|STANDARD_ERROR_OF_MEAN|5.89||0.5704|TWO_SIDED|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72||1.62|-8.31|0.5704
71150420|NCT00658359|141793851|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.94|STANDARD_ERROR_OF_MEAN|5.7||0.2972|TWO_SIDED|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72||-1.14|-10.73|0.2972
71150421|NCT00658359|141793851|SUPERIORITY_OR_OTHER||Estimated rate difference|3.75|STANDARD_ERROR_OF_MEAN|4.91||0.4455|TWO_SIDED|60.0|-0.39|7.89|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12||7.89|-0.39|0.4455
71150422|NCT00658359|141793851|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.69|STANDARD_ERROR_OF_MEAN|4.34||0.873|TWO_SIDED|60.0|-4.35|2.96|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12||2.96|-4.35|0.8730
71150423|NCT00658359|141793852|SUPERIORITY_OR_OTHER||Estimated rate difference|-10.52|STANDARD_ERROR_OF_MEAN|5.71||0.0654|TWO_SIDED|60.0|-15.33|-5.71|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 15||-5.71|-15.33|0.0654
71150424|NCT00658359|141793852|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.08|STANDARD_ERROR_OF_MEAN|6.37||0.3398|TWO_SIDED|60.0|-11.43|-0.72|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 15||-0.72|-11.43|0.3398
70876050|NCT00715078|141236153|NON_INFERIORITY_OR_EQUIVALENCE|Cohort C is considered non-inferior to Cohort A if the lower limit of the 90% confidence interval for the ratio of Cohort C vs. Cohort A in the geometric mean of cumulative CD54 upregulation ratio is \>0.8. The use of one-sided CI is based on an assumption that a higher concentration will correspond to a higher CD54 upregulation ratio. The use of 0.8 as margin is based on the assumption that a relative difference of \<20% in upregulation ratios may not be clinically significant.|the ratio of geometric means|0.907||||0.1443|TWO_SIDED|90.0|0.813|1.013|||ANOVA|||The sample size determination is based on a standard deviation of 0.45 for the log transformed CD54 upregulation ratio estimated from previous studies assuming there is no difference in central values between the two compared cohorts. A sample size of 38 subjects per cohort will provide 70% power for the non-inferiority test for the two pairwise comparisons (Cohort B vs. Cohort A and Cohort C vs. Cohort A).||1.013|0.813|0.1443
70876051|NCT01084174|141236199|OTHER|||||||0.003|||||||Regression, Linear|Analyzed by linear regression models using generalized estimating equations to account for repeated measures over time with robust standard errors||||||.003
70876052|NCT01084174|141236200|OTHER||||||<|0.001|||||||Regression, Linear|||||||<.001
70876053|NCT01084174|141236201|OTHER||||||<|0.001|||||||Regression, Linear|||||||<.001
70876054|NCT01084174|141236202|OTHER|||||||0.4|||||||Regression, Linear|||||||0.40
70876055|NCT01084174|141236203|OTHER|||||||0.07|||||||Regression, Linear|||||||.07
70876056|NCT01084174|141236204|OTHER|||||||0.007|||||||Regression, Linear|||||||.007
70876057|NCT00673465|141236207|SUPERIORITY_OR_OTHER||Difference in least squares mean|-4.4||||0.5269|TWO_SIDED|95.0|-18.5|9.7|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.||||9.7|-18.5|0.5269
70876058|NCT00673465|141236207|SUPERIORITY_OR_OTHER||Difference in least squares mean|-53.9|||<|0.0001|TWO_SIDED|95.0|-68.1|-39.8|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.||||-39.8|-68.1|<0.0001
70876059|NCT00673465|141236211|SUPERIORITY_OR_OTHER||Difference in least squares mean|-2.81||||0.741|TWO_SIDED|95.0|-20.1|14.5|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.||||14.5|-20.1|0.7410
70876060|NCT00673465|141236211|SUPERIORITY_OR_OTHER||Difference in least squares mean|-63.6|||<|0.0001|TWO_SIDED|95.0|-80.9|-46.2|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.||||-46.2|-80.9|<0.0001
70876061|NCT00673465|141236213|SUPERIORITY_OR_OTHER||Difference in least squares mean|-3.59||||0.3146|TWO_SIDED|95.0|-10.8|3.6|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.||||3.6|-10.8|0.3146
70876062|NCT00673465|141236213|SUPERIORITY_OR_OTHER||Difference in least squares mean|-26.6|||<|0.0001|TWO_SIDED|95.0|-33.8|-19.4|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.||||-19.4|-33.8|<0.0001
70876063|NCT02237950|141236229|SUPERIORITY|||||||0.015|||||||Regression, Logistic|||||||0.015
70876064|NCT02237950|141236230|SUPERIORITY|||||||0.007|||||||Log Rank|||||||0.007
70956226|NCT05172050|141416028|SUPERIORITY||Odds Ratio (OR)|2.34||||0.5378|TWO_SIDED|95.0|0.35|20.153||Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.|Regression, Logistic|||This sensitivity analysis is conducted on the per protocol (PP) population: n=18 in the Raloxifene 60 mg arm; n=17 in the Raloxifene 120 mg arm; and n=17 in the Placebo arm||20.153|0.350|0.5378
71150425|NCT00658359|141793852|SUPERIORITY_OR_OTHER||Estimated rate difference|-8.75|STANDARD_ERROR_OF_MEAN|6.23||0.1601|TWO_SIDED|60.0|-13.99|-3.51|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18||-3.51|-13.99|0.1601
71150426|NCT00658359|141793852|SUPERIORITY_OR_OTHER||Estimated rate difference|-7.64|STANDARD_ERROR_OF_MEAN|6.49||0.239|TWO_SIDED|60.0|-13.1|-2.18|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18||-2.18|-13.10|0.2390
71150427|NCT00658359|141793852|SUPERIORITY_OR_OTHER||Estimated rate difference|-7.08|STANDARD_ERROR_OF_MEAN|6.4||0.2685|TWO_SIDED|60.0|-12.47|-1.7|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24||-1.70|-12.47|0.2685
71150428|NCT00658359|141793852|SUPERIORITY_OR_OTHER||Estimated rate difference|-7.64|STANDARD_ERROR_OF_MEAN|6.49||0.239|TWO_SIDED|60.0|-13.1|-2.18|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24||-2.18|-13.10|0.2390
71150429|NCT00658359|141793852|SUPERIORITY_OR_OTHER||Estimated rate difference|-8.81|STANDARD_ERROR_OF_MEAN|6.55||0.1785|TWO_SIDED|60.0|-14.32|-3.3|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30||-3.30|-14.32|0.1785
71150430|NCT00658359|141793852|SUPERIORITY_OR_OTHER||Estimated rate difference|-9.37|STANDARD_ERROR_OF_MEAN|6.63||0.158|TWO_SIDED|60.0|-14.95|-3.78|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30||-3.78|-14.95|0.1580
70876065|NCT02237950|141236231|SUPERIORITY|||||||0.002|||||||Regression, Logistic|||||||0.002
70876066|NCT02237950|141236232|SUPERIORITY|||||||0.014|||||||Regression, Logistic|||||||0.014
70876067|NCT02237950|141236233|SUPERIORITY|||||||0.012|||||||Regression, Logistic|||||||0.012
70876068|NCT02237950|141236234|SUPERIORITY|||||||0.059|||||||Regression, Logistic|||||||0.059
70876069|NCT02237950|141236235|SUPERIORITY|||||||0.008|||||||Regression, Logistic|||||||0.008
70876070|NCT01574326|141236240|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-0.9||||0.001|TWO_SIDED|95.0|-1.44|-0.37|||ANCOVA|Threshold for significance ≤ 0.05.||Primary efficacy endpoint, change from baseline to Week 2 in serum phosphorus, was compared between treatment groups using analysis of covariance (ANCOVA) with baseline phosphorus and screening BSA as covariates and fixed effect for treatment. No center effect was included in the model. The estimate of the treatment difference (Sevelamer Carbonate - Placebo) and its 95% CI were presented. Significance was to be declared if the p-value was ≤0.05.||-0.37|-1.44|0.001
70876071|NCT01288469|141236324|SUPERIORITY_OR_OTHER||LS Mean Difference|-55.82|||<|0.0001|TWO_SIDED|95.0|-65.62|-46.03||Threshold for significance ≤0.05.|ANCOVA||Alirocumab vs. placebo|Throughout the ANCOVA model, the Alirocumab + atorvastatin 80 mg group was compared to the placebo + atorvastatin 80 mg group using appropriate contrast and the 95% confidence interval (CI) of the difference was provided.||-46.03|-65.62|<0.0001
70876072|NCT01867021|141236363|NON_INFERIORITY_OR_EQUIVALENCE|The HI GMTs of TIV vaccine for strain A/H1N1 considered non-inferior to HI GMTs of TIVf vaccine if the upper limit of the two-sided 95% CI on the ratio of GMTs (GMT TIVf / GMT TIV) was ≤1.5|Ratio of GMTs|1.85|||||TWO_SIDED|95.0|1.66|2.06|||ANCOVA|Not applicable(NA)||Non-inferiority of HI GMTs of TIV vaccine over HI GMTs of TIVf vaccine for the strain A/H1N1 at day 22||2.06|1.66|
70876073|NCT01867021|141236363|NON_INFERIORITY_OR_EQUIVALENCE|The HI GMTs of TIV vaccine for strain A/H3N2 considered non-inferior to HI GMTs of TIVf vaccine if the upper limit of the two-sided 95% CI on the ratio of GMTs (GMT TIVf / GMT TIV) was ≤1.5|Ratio of GMTs|1.5|||||TWO_SIDED|95.0|1.38|1.64|||ANCOVA|||Non-inferiority of HI GMTs of TIV vaccine over HI GMTs of TIVf vaccine for the strain A/H3N2 at day 22||1.64|1.38|
70876074|NCT01867021|141236363|NON_INFERIORITY_OR_EQUIVALENCE|The HI GMTs of TIV vaccine for strain B considered non-inferior to HI GMTs of TIVf vaccine if the upper limit of the two-sided 95% CI on the ratio of GMTs (GMT TIVf / GMT TIV) was ≤1.5|Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.93|1.08|||ANCOVA|||Non-inferiority of HI GMTs of TIV vaccine over HI GMTs of TIVf vaccine for the strain B at day 22||1.08|0.93|
70876075|NCT01867021|141236364|NON_INFERIORITY_OR_EQUIVALENCE|Percentage of subjects with HI seroconversion of TIV vaccine for strain A/H1N1 considered non-inferior to percentage of subjects with HI seroconversion of TIVf vaccine if the upper limit of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion TIVf - Seroconversion TIV) was ≤10%.|Difference in seroconversion rates|9.0|||||TWO_SIDED|95.0|5.6|11.5|||Miettinen and Nurminen|||Non-inferiority of percentage of subjects with HI seroconversion of TIV vaccine over TIVf vaccine for the strain A/H1N1 at day 22||11.5|5.6|
70956227|NCT05172050|141416028|SUPERIORITY||Odds Ratio (OR)|1.209|||>|0.999|TWO_SIDED|95.0|0.185|8.589||Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.|Regression, Logistic|||This sensitivity analysis is conducted on the per protocol (PP) population: n=18 in the Raloxifene 60 mg arm; n=17 in the Raloxifene 120 mg arm; and n=17 in the Placebo arm||8.589|0.185|>0.999
70956228|NCT05172050|141416029|SUPERIORITY||Odds Ratio (OR)|1.114|||>|0.999|TWO_SIDED|95.0|0.219|5.708|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.||at Day 14||5.708|0.219|>0.999
70956229|NCT05172050|141416029|SUPERIORITY||Odds Ratio (OR)|3.202||||0.2553|TWO_SIDED|95.0|0.541|22.116|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.||At day 14||22.116|0.541|0.2553
70956230|NCT05172050|141416029|SUPERIORITY||Odds Ratio (OR)|2.16||||0.6189|TWO_SIDED|95.0|0.294|18.532|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.||at Day 28||18.532|0.294|0.6189
70956231|NCT05172050|141416029|SUPERIORITY||Odds Ratio (OR)|7.22||||0.1662|TWO_SIDED|95.0|0.586|413.499|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.||at Day 28||413.499|0.586|0.1662
70956232|NCT05172050|141416030|SUPERIORITY||Odds Ratio (OR)|0.972|||>|0.999|TWO_SIDED|95.0|0.193|4.906|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects||at Day 7||4.906|0.193|>0.999
70956233|NCT05172050|141416030|SUPERIORITY||Odds Ratio (OR)|1.156|||>|0.999|TWO_SIDED|95.0|0.2|6.822|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects||at Day 7||6.822|0.200|>0.999
70956234|NCT05172050|141416030|SUPERIORITY||Odds Ratio (OR)|1.066|||>|0.999|TWO_SIDED|95.0|0.208|5.478|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects||at Day 28||5.478|0.208|>0.999
70956235|NCT05172050|141416030|SUPERIORITY||Odds Ratio (OR)|2.068||||0.5465|TWO_SIDED|95.0|0.369|12.58|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects||at Day 28||12.580|0.369|0.5465
70956236|NCT05172050|141416033|SUPERIORITY|||||||0.3899||||||P-Value comparing % among treatment groups Raloxifene 60mg versus Placebo using Fisher's Exact test.|Fisher Exact|||The proportion of hospitalized participants who at the beginning of the study were at domicile isolation at Day 7, Day 14 and Day 28 after randomization was analysed using comparison of proportions (i.e. comparisons of each active treatment group versus placebo at each assessment day) through Fisher's exact test and was summarized using frequency and percent by treatment and visit. Herein Day 7 R60 vs Placebo||||0.3899
70956237|NCT05172050|141416033|SUPERIORITY|||||||0.4075||||||P-Value comparing % among treatment groups Raloxifene 120 mg versus Placebo using Fisher's Exact test.|Fisher Exact|||The proportion of hospitalized participants who at the beginning of the study were at domicile isolation at Day 7, Day 14 and Day 28 after randomization was analysed using comparison of proportions (i.e. comparisons of each active treatment group versus placebo at each assessment day) through Fisher's exact test and was summarized using frequency and percent by treatment and visit. Herein Day 7 R120 vs placebo||||0.4075
70956238|NCT05172050|141416033|SUPERIORITY|||||||0.3899||||||P-Value comparing % among treatment groups Raloxifene 60mg versus Placebo using Fisher's Exact test.|Fisher Exact|||The proportion of hospitalized participants who at the beginning of the study were at domicile isolation at Day 7, Day 14 and Day 28 after randomization was analysed using comparison of proportions (i.e. comparisons of each active treatment group versus placebo at each assessment day) through Fisher's exact test and was summarized using frequency and percent by treatment and visit. Herein Day 14 R60 vs placebo||||0.3899
70956239|NCT05172050|141416033|SUPERIORITY|||||||0.4075|||||||Fisher Exact|P-Value comparing % among treatment groups Raloxifene 120mg versus Placebo using Fisher's Exact test.||The proportion of hospitalized participants who at the beginning of the study were at domicile isolation at Day 7, Day 14 and Day 28 after randomization was analysed using comparison of proportions (i.e. comparisons of each active treatment group versus placebo at each assessment day) through Fisher's exact test and was summarized using frequency and percent by treatment and visit. Herein Day 14 R120 vs placebo||||0.4075
70956240|NCT05172050|141416033|SUPERIORITY|||||||0.6846||||||P-Value comparing % among treatment groups Raloxifene 60mg versus Placebo using Fisher's Exact test.|Fisher Exact|||The proportion of hospitalized participants who at the beginning of the study were at domicile isolation at Day 7, Day 14 and Day 28 after randomization was analysed using comparison of proportions (i.e. comparisons of each active treatment group versus placebo at each assessment day) through Fisher's exact test and was summarized using frequency and percent by treatment and visit. Herein Day 28 R60 vs placebo||||0.6846
70956241|NCT05172050|141416033|SUPERIORITY|||||||0.6614||||||P-Value comparing % among treatment groups Raloxifene 120mg versus Placebo using Fisher's Exact test.|Fisher Exact|||The proportion of hospitalized participants who at the beginning of the study were at domicile isolation at Day 7, Day 14 and Day 28 after randomization was analysed using comparison of proportions (i.e. comparisons of each active treatment group versus placebo at each assessment day) through Fisher's exact test and was summarized using frequency and percent by treatment and visit. Herein Day 28 R120 vs placebo||||0.6614
70956242|NCT05172050|141416035|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||Log Rank|||||1.00|1.00|
70956243|NCT05172050|141416035|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|1.0|1.0||p value= not estimable|Log Rank|||||1.00|1.00|
70956244|NCT00969709|141416038|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.23||||0.0186|TWO_SIDED|95.0|-5.92|-0.54|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-0.54|-5.92|0.0186
71150431|NCT00658359|141793852|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.27|STANDARD_ERROR_OF_MEAN|6.81||0.0718|TWO_SIDED|60.0|-18.0|-6.53|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36||-6.53|-18.00|0.0718
70876076|NCT01867021|141236364|NON_INFERIORITY_OR_EQUIVALENCE|Percentage of subjects with HI seroconversion of TIV vaccine for strain A/H3N2 considered non-inferior to percentage of subjects with HI seroconversion of TIVf vaccine if the upper limit of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion TIVf - Seroconversion TIV) was ≤10%.|Difference in seroconversion rates|13.0|||||TWO_SIDED|95.0|10.1|16.1|||Miettinen and Nurminen|||Non-inferiority of percentage of subjects with HI seroconversion of TIV vaccine over TIVf vaccine for the strain A/H3N2 at day 22||16.1|10.1|
70876077|NCT01867021|141236364|NON_INFERIORITY_OR_EQUIVALENCE|Percentage of subjects with HI seroconversion of TIV vaccine for strain B considered non-inferior to percentage of subjects with HI seroconversion of TIVf vaccine if the upper limit of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion TIVf - Seroconversion TIV) was ≤10%.|Difference in seroconversion rates|-1.0|||||TWO_SIDED|95.0|-5.0|2.3|||Miettinen and Nurminen|||Non-inferiority of percentage of subjects with HI seroconversion of TIV vaccine over TIVf vaccine for the strain B at day 22||2.3|-5|
70876078|NCT00560859|141236396|SUPERIORITY_OR_OTHER||difference of change from baseline|2.0||||0.16|||||||ANCOVA|||||||0.16
70876079|NCT01529346|141236435|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.38|0.22||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.22|-0.38|
70876080|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.2|0.39||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.39|-0.20|
70876081|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.28|0.32||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.32|-0.28|
70876082|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-0.41|0.24||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.24|-0.41|
70876083|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.32|0.44||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.44|-0.32|
70876084|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|0.01|0.77||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.77|0.01|
70876085|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.22|0.54||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.54|-0.22|
70876086|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|0.66|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|0.24|1.07||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.07|0.24|
70876087|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-0.37|0.42||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.42|-0.37|
70876088|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|0.0|0.78||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.78|-0.00|
70956245|NCT00969709|141416038|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.99||||0.0038|TWO_SIDED|95.0|-6.69|-1.29|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-1.29|-6.69|0.0038
70956246|NCT00969709|141416038|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.86||||0.0005|TWO_SIDED|95.0|-7.59|-2.12|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-2.12|-7.59|0.0005
70956247|NCT00969709|141416039|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.41||||0.1687|TWO_SIDED|95.0|-3.42|0.6|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||0.60|-3.42|0.1687
70956248|NCT00969709|141416039|SUPERIORITY_OR_OTHER||least squares mean difference|-2.51||||0.0151|TWO_SIDED|95.0|-4.54|-0.49|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-0.49|-4.54|0.0151
70956249|NCT00969709|141416039|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.57||||0.0141|TWO_SIDED|95.0|-4.62|-0.52|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-0.52|-4.62|0.0141
71150432|NCT00658359|141793852|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.83|STANDARD_ERROR_OF_MEAN|6.9||0.0629|TWO_SIDED|60.0|-18.63|-7.02|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36||-7.02|-18.63|0.0629
71150433|NCT00658359|141793852|SUPERIORITY_OR_OTHER||Estimated rate differences|-15.89|STANDARD_ERROR_OF_MEAN|7.07||0.0246|TWO_SIDED|60.0|-21.84|-9.94|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42||-9.94|-21.84|0.0246
71150434|NCT00658359|141793852|SUPERIORITY_OR_OTHER||Estimated rate difference|-16.45|STANDARD_ERROR_OF_MEAN|7.15||0.0214|TWO_SIDED|60.0|-22.46|-10.43|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42||-10.43|-22.46|0.0214
71150435|NCT00658359|141793852|SUPERIORITY_OR_OTHER||Estimated rate difference|-15.89|STANDARD_ERROR_OF_MEAN|7.07||0.0246|TWO_SIDED|60.0|-21.84|-9.94|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48||-9.94|-21.84|0.0246
70876089|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-0.29|0.5||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.50|-0.29|
70876090|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|1.02|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|0.59|1.45||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.45|0.59|
70876091|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.21|0.62||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.62|-0.21|
70956250|NCT02980731|141416040|SUPERIORITY||||||=|0.004||||||P-value is derived from a paired t-test of H0: mean difference (Week 48 - baseline) ≤ 5 versus H1: mean difference (Week 48 - baseline) \> 5|t-test, 2 sided|||||||=0.004
70956251|NCT00435591|141416101|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.23|||||TWO_SIDED|95.0|-0.37|0.83||||||"Aggregated data were used to determine differences between groups. Statistical analysis is relevant to the aggregated data of all rows except the no assessment row."||0.83|-0.37|
70876092|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.07|0.76||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.76|-0.07|
70876093|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.11|0.72||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.72|-0.11|
70876094|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|0.85|1.75||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.75|0.85|
70956252|NCT00210470|141416108|EQUIVALENCE|The correlation of each of the above variables at biopsy/Day 1, surgery/Day 21, and change with percent change in the longest diameter (LD) of the primary tumor was calculated using Spearman rank correlations (183 correlations). Due to outliers in the distribution of percent change in the longest diameter, it was felt that the Spearman rank correlations would be more appropriate than Pearson correlations.|||||<|0.1|||||||Spearman Rank|||||||<0.10
70876095|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.04|0.81||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.81|-0.04|
70876096|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.1|0.75||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.75|-0.10|
70876097|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|0.38|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.05|0.81||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.81|-0.05|
70956253|NCT02245737|141416117|SUPERIORITY||LS Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.77||0.232|TWO_SIDED|95.0|-2.447|0.594|||Mixed Models Analysis|||||0.594|-2.447|0.232
70956254|NCT02245737|141416117|SUPERIORITY||LS Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.78||0.599|TWO_SIDED|95.0|-1.124|1.947|||Mixed Models Analysis|||||1.947|-1.124|0.599
70956255|NCT02245737|141416118|SUPERIORITY||LS Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.83||0.971|TWO_SIDED|95.0|-1.609|1.669|||Mixed Models Analysis|||||1.669|-1.609|0.971
70956256|NCT02245737|141416118|SUPERIORITY||LS Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.85||0.923|TWO_SIDED|95.0|-1.58|1.743|||Mixed Models Analysis|||||1.743|-1.580|0.923
71150436|NCT00658359|141793852|SUPERIORITY_OR_OTHER||Estimated rate difference|-16.45|STANDARD_ERROR_OF_MEAN|7.15||0.0214|TWO_SIDED|60.0|-22.46|-10.43|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48||-10.43|-22.46|0.0214
71150437|NCT00658359|141793852|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.02|STANDARD_ERROR_OF_MEAN|7.24||0.0128|TWO_SIDED|60.0|-24.12|-11.93|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54||-11.93|-24.12|0.0128
70876098|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|1.69|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|1.22|2.15||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||2.15|1.22|
70956257|NCT02245737|141416119|SUPERIORITY||LS Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.53||0.796|TWO_SIDED|95.0|-1.172|0.899|||Mixed Models Analysis|||||0.899|-1.172|0.796
70876099|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|0.01|0.99||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.99|0.01|
70956258|NCT02245737|141416119|SUPERIORITY||LS Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.53||0.252|TWO_SIDED|95.0|-0.437|1.66|||Mixed Models Analysis|||||1.660|-0.437|0.252
71150438|NCT00658359|141793852|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.58|STANDARD_ERROR_OF_MEAN|7.32||0.0111|TWO_SIDED|60.0|-24.74|-12.42|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54||-12.42|-24.74|0.0111
71150439|NCT00658359|141793852|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.02|STANDARD_ERROR_OF_MEAN|7.24||0.0128|TWO_SIDED|60.0|-24.12|-11.93|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60||-11.93|-24.12|0.0128
71150440|NCT00658359|141793852|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.58|STANDARD_ERROR_OF_MEAN|7.32||0.0111|TWO_SIDED|60.0|-24.74|-12.42|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60||-12.42|-24.74|0.0111
71150441|NCT00658359|141793852|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.02|STANDARD_ERROR_OF_MEAN|7.24||0.0128|TWO_SIDED|60.0|-24.12|-11.93|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66||-11.93|-24.12|0.0128
71150442|NCT00658359|141793852|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.58|STANDARD_ERROR_OF_MEAN|7.32||0.0111|TWO_SIDED|60.0|-24.74|-12.42|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66||-12.42|-24.74|0.0111
71150443|NCT00658359|141793852|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.02|STANDARD_ERROR_OF_MEAN|7.24||0.0128|TWO_SIDED|60.0|-24.12|-11.93|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72||-11.93|-24.12|0.0128
71150444|NCT00658359|141793852|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.58|STANDARD_ERROR_OF_MEAN|7.32||0.0111|TWO_SIDED|60.0|-24.74|-12.42|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72||-12.42|-24.74|0.0111
71150445|NCT00658359|141793852|SUPERIORITY_OR_OTHER||Estimated rate difference|-7.4|STANDARD_ERROR_OF_MEAN|5.41||0.1715|TWO_SIDED|60.0|-11.95|-2.84|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12||-2.84|-11.95|0.1715
71150446|NCT00658359|141793852|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.8|STANDARD_ERROR_OF_MEAN|5.87||0.4131|TWO_SIDED|60.0|-9.74|0.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12||0.14|-9.74|0.4131
71150447|NCT00658359|141793853|SUPERIORITY_OR_OTHER||Estimated rate difference|2.19|STANDARD_ERROR_OF_MEAN|5.12||0.6694|TWO_SIDED|60.0|-2.12|6.5|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 15||6.50|-2.12|0.6694
70876100|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|0.54|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|0.05|1.03||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.03|0.05|
71150448|NCT00658359|141793853|SUPERIORITY_OR_OTHER||Estimated rate difference|1.45|STANDARD_ERROR_OF_MEAN|5.18||0.7799|TWO_SIDED|60.0|-2.91|5.8|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 15||5.80|-2.91|0.7799
71150449|NCT00658359|141793853|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.99|STANDARD_ERROR_OF_MEAN|5.51||0.8572|TWO_SIDED|60.0|-5.63|3.65|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18||3.65|-5.63|0.8572
71150450|NCT00658359|141793853|SUPERIORITY_OR_OTHER||Estimated rate difference|-1.73|STANDARD_ERROR_OF_MEAN|5.56||0.7555|TWO_SIDED|60.0|-6.41|2.95|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18||2.95|-6.41|0.7555
71150451|NCT00658359|141793853|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.99|STANDARD_ERROR_OF_MEAN|5.51||0.8572|TWO_SIDED|60.0|-5.63|3.65|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24||3.65|-5.63|0.8572
71150452|NCT00658359|141793853|SUPERIORITY_OR_OTHER||Estimated rate difference|3.82|STANDARD_ERROR_OF_MEAN|6.22||0.539|TWO_SIDED|60.0|-1.41|9.06|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24||9.06|-1.41|0.5390
71150453|NCT00658359|141793853|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.64|STANDARD_ERROR_OF_MEAN|5.7||0.6432|TWO_SIDED|60.0|-7.44|2.16|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||2.16|-7.44|0.6432
71150454|NCT00658359|141793853|SUPERIORITY_OR_OTHER||Estimated rate difference|2.18|STANDARD_ERROR_OF_MEAN|6.39||0.7336|TWO_SIDED|60.0|-3.2|7.55|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||7.55|-3.20|0.7336
71150455|NCT00658359|141793853|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.74|STANDARD_ERROR_OF_MEAN|6.57||0.9099|TWO_SIDED|60.0|-6.28|4.79|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||4.79|-6.28|0.9099
71150456|NCT00658359|141793853|SUPERIORITY_OR_OTHER||Estimated rate difference|0.77|STANDARD_ERROR_OF_MEAN|6.87||0.9106|TWO_SIDED|60.0|-5.01|6.56|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||6.56|-5.01|0.9106
71150457|NCT00658359|141793853|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.4|STANDARD_ERROR_OF_MEAN|6.91||0.5244|TWO_SIDED|60.0|-10.22|1.42|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||1.42|-10.22|0.5244
71150458|NCT00658359|141793853|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.9|STANDARD_ERROR_OF_MEAN|7.38||0.9029|TWO_SIDED|60.0|-7.11|5.31|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||5.31|-7.11|0.9029
71150459|NCT00658359|141793853|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.58|STANDARD_ERROR_OF_MEAN|7.38||0.7267|TWO_SIDED|60.0|-8.78|3.63|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||3.63|-8.78|0.7267
71150460|NCT00658359|141793853|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.73|STANDARD_ERROR_OF_MEAN|7.52||0.7168|TWO_SIDED|60.0|-9.06|3.6|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||3.60|-9.06|0.7168
71150461|NCT00658359|141793853|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.4|STANDARD_ERROR_OF_MEAN|7.51||0.5574|TWO_SIDED|60.0|-10.72|1.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||1.91|-10.72|0.5574
71150462|NCT00658359|141793853|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.56|STANDARD_ERROR_OF_MEAN|7.65||0.5515|TWO_SIDED|60.0|-10.99|1.88|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||1.88|-10.99|0.5515
71150463|NCT00658359|141793853|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.4|STANDARD_ERROR_OF_MEAN|7.51||0.5574|TWO_SIDED|60.0|-10.72|1.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||1.91|-10.72|0.5574
71150464|NCT00658359|141793853|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.3|STANDARD_ERROR_OF_MEAN|7.87||0.7704|TWO_SIDED|60.0|-8.92|4.33|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||4.33|-8.92|0.7704
71150465|NCT00658359|141793853|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.4|STANDARD_ERROR_OF_MEAN|7.51||0.5574|TWO_SIDED|60.0|-10.72|1.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||1.91|-10.72|0.5574
71150466|NCT00658359|141793853|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.3|STANDARD_ERROR_OF_MEAN|7.87||0.7704|TWO_SIDED|60.0|-8.92|4.33|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||4.33|-8.92|0.7704
71150467|NCT00658359|141793853|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.44|STANDARD_ERROR_OF_MEAN|7.83||0.9551|TWO_SIDED|60.0|-7.03|6.15|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||6.15|-7.03|0.9551
71150468|NCT00658359|141793853|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.3|STANDARD_ERROR_OF_MEAN|7.87||0.7704|TWO_SIDED|60.0|-8.92|4.33|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||4.33|-8.92|0.7704
71150469|NCT00658359|141793853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75|STANDARD_ERROR_OF_MEAN|4.91||0.4455|TWO_SIDED|60.0|-0.39|7.89|||Wald Test|||Month 12||7.89|-0.39|0.4455
71150470|NCT00658359|141793853|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.69|STANDARD_ERROR_OF_MEAN|4.34||0.873|TWO_SIDED|60.0|-4.35|2.96|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 12||2.96|-4.35|0.8730
71150471|NCT00658359|141793854|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.98|STANDARD_ERROR_OF_MEAN|6.67||0.2957|TWO_SIDED|60.0|-12.6|-1.36|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 15||-1.36|-12.60|0.2957
71150472|NCT00658359|141793854|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.65|STANDARD_ERROR_OF_MEAN|7.14||0.6097|TWO_SIDED|60.0|-9.66|2.37|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 15||2.37|-9.66|0.6097
71150473|NCT00658359|141793854|SUPERIORITY_OR_OTHER||Estimated rate difference|-8.57|STANDARD_ERROR_OF_MEAN|6.79||0.2064|TWO_SIDED|60.0|-14.28|-2.86|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18||-2.86|-14.28|0.2064
71150474|NCT00658359|141793854|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.24|STANDARD_ERROR_OF_MEAN|7.25||0.4696|TWO_SIDED|60.0|-11.34|0.86|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18||0.86|-11.34|0.4696
71150475|NCT00658359|141793854|SUPERIORITY_OR_OTHER||Estimated rate difference|-8.57|STANDARD_ERROR_OF_MEAN|7.04||0.2238|TWO_SIDED|60.0|-14.5|-2.64|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24||-2.64|-14.50|0.2238
71150476|NCT00658359|141793854|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.96|STANDARD_ERROR_OF_MEAN|7.52||0.5093|TWO_SIDED|60.0|-11.29|1.37|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24||1.37|-11.29|0.5093
71150477|NCT00658359|141793854|SUPERIORITY_OR_OTHER||Estimated rate difference|-8.57|STANDARD_ERROR_OF_MEAN|7.04||0.2238|TWO_SIDED|60.0|-14.5|-2.64|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||-2.64|-14.50|0.2238
71150478|NCT00658359|141793854|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.16|STANDARD_ERROR_OF_MEAN|7.89||0.7846|TWO_SIDED|60.0|-8.8|4.48|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||4.48|-8.80|0.7846
71150479|NCT00658359|141793854|SUPERIORITY_OR_OTHER||Estimated rate difference|-10.3|STANDARD_ERROR_OF_MEAN|7.16||0.1501|TWO_SIDED|60.0|-16.33|-4.28|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||-4.28|-16.33|0.1501
71150480|NCT00658359|141793854|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.89|STANDARD_ERROR_OF_MEAN|8.0||0.6263|TWO_SIDED|60.0|-10.62|2.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||2.84|-10.62|0.6263
71150481|NCT00658359|141793854|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.44|STANDARD_ERROR_OF_MEAN|7.35||0.0905|TWO_SIDED|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||-6.25|-18.62|0.0905
71150482|NCT00658359|141793854|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.03|STANDARD_ERROR_OF_MEAN|8.16||0.4604|TWO_SIDED|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||0.84|-12.90|0.4604
71150483|NCT00658359|141793854|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.44|STANDARD_ERROR_OF_MEAN|7.35||0.0905|TWO_SIDED|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||-6.25|-18.62|0.0905
71150484|NCT00658359|141793854|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.03|STANDARD_ERROR_OF_MEAN|8.16||0.4604|TWO_SIDED|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||0.84|-12.90|0.4604
71150485|NCT00658359|141793854|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.44|STANDARD_ERROR_OF_MEAN|7.35||0.0905|TWO_SIDED|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||-6.25|-18.62|0.0905
71150486|NCT00658359|141793854|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.03|STANDARD_ERROR_OF_MEAN|8.16||0.4604|TWO_SIDED|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||0.84|-12.90|0.4604
71150487|NCT00658359|141793854|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.44|STANDARD_ERROR_OF_MEAN|7.35||0.0905|TWO_SIDED|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||-6.25|-18.62|0.0905
71150488|NCT00658359|141793854|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.03|STANDARD_ERROR_OF_MEAN|8.16||0.4604|TWO_SIDED|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||0.84|-12.90|0.4604
71150489|NCT00658359|141793854|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.44|STANDARD_ERROR_OF_MEAN|7.35||0.0905|TWO_SIDED|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||-6.25|-18.62|0.0905
71150490|NCT00658359|141793854|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.03|STANDARD_ERROR_OF_MEAN|8.16||0.4604|TWO_SIDED|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||0.84|-12.90|0.4604
71150491|NCT00658359|141793854|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.44|STANDARD_ERROR_OF_MEAN|7.35||0.0905|TWO_SIDED|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||-6.25|-18.62|0.0905
70956259|NCT02245737|141416120|SUPERIORITY||LS Mean Difference (Final Values)|1.11|STANDARD_ERROR_OF_MEAN|1.4||0.428|TWO_SIDED|95.0|-1.637|3.852|||Mixed Models Analysis|||||3.852|-1.637|0.428
70956260|NCT02245737|141416120|SUPERIORITY||LS Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|1.42||0.926|TWO_SIDED|95.0|-2.918|2.655|||Mixed Models Analysis|||||2.655|-2.918|0.926
70956261|NCT02245737|141416121|SUPERIORITY||LS Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.24||0.533|TWO_SIDED|95.0|-0.322|0.622|||Mixed Models Analysis|||||0.622|-0.322|0.533
71150492|NCT00658359|141793854|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.03|STANDARD_ERROR_OF_MEAN|8.16||0.4604|TWO_SIDED|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||0.84|-12.90|0.4604
71150493|NCT00658359|141793854|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.29|STANDARD_ERROR_OF_MEAN|6.31||0.7166|TWO_SIDED|60.0|-7.61|3.02|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 12||3.02|-7.61|0.7166
71150494|NCT00658359|141793854|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.51|STANDARD_ERROR_OF_MEAN|6.24||0.4692|TWO_SIDED|60.0|-9.76|0.73|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 12||0.73|-9.76|0.4692
71150495|NCT00658359|141793855|SUPERIORITY_OR_OTHER||Estimated rate difference|1.69|STANDARD_ERROR_OF_MEAN|1.68||0.3132|TWO_SIDED|60.0|0.28|3.11|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||3.11|0.28|0.3132
71150496|NCT00658359|141793855|SUPERIORITY_OR_OTHER||Estimated rate difference|1.69|STANDARD_ERROR_OF_MEAN|1.68||0.3132|TWO_SIDED|60.0|0.28|3.11|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||3.11|0.28|0.3132
71150497|NCT00658359|141793855|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||5.57|1.46|0.1503
71150498|NCT00658359|141793855|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||5.57|1.46|0.1503
71150499|NCT00658359|141793855|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||5.57|1.46|0.1503
71150500|NCT00658359|141793855|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||5.57|1.46|0.1503
71150501|NCT00658359|141793855|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||5.57|1.46|0.1503
71150502|NCT00658359|141793855|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||5.57|1.46|0.1503
71150503|NCT00658359|141793855|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||5.57|1.46|0.1503
71150504|NCT00658359|141793855|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||5.57|1.46|0.1503
71150505|NCT00658359|141793855|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||5.57|1.46|0.1503
70956262|NCT02245737|141416121|SUPERIORITY||LS Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.24||0.537|TWO_SIDED|95.0|-0.328|0.63|||Mixed Models Analysis|||||0.630|-0.328|0.537
71150506|NCT00658359|141793855|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||5.57|1.46|0.1503
71150507|NCT00658359|141793855|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||5.57|1.46|0.1503
71150508|NCT00658359|141793855|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||5.57|1.46|0.1503
71150509|NCT00658359|141793855|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||5.57|1.46|0.1503
71150510|NCT00658359|141793856|SUPERIORITY_OR_OTHER||Estimated rate difference|-1.85|STANDARD_ERROR_OF_MEAN|1.83||0.3128|TWO_SIDED|60.0|-3.4|-0.31|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 15||-0.31|-3.40|0.3128
71150511|NCT00658359|141793856|SUPERIORITY_OR_OTHER||Estimated rate difference|1.59|STANDARD_ERROR_OF_MEAN|1.57||0.3134|TWO_SIDED|60.0|0.26|2.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18||2.91|0.26|0.3134
71150512|NCT00658359|141793856|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.26|STANDARD_ERROR_OF_MEAN|2.42||0.9129|TWO_SIDED|60.0|-2.3|1.77|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18||1.77|-2.30|0.9129
71150513|NCT00658359|141793856|SUPERIORITY_OR_OTHER||Estimated rate difference|1.59|STANDARD_ERROR_OF_MEAN|1.57||0.3134|TWO_SIDED|60.0|0.26|2.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24||2.91|0.26|0.3134
71150514|NCT00658359|141793856|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.19|STANDARD_ERROR_OF_MEAN|3.61||0.2447|TWO_SIDED|60.0|-7.23|-1.16|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24||-1.16|-7.23|0.2447
71150515|NCT00658359|141793856|SUPERIORITY_OR_OTHER||Estimated rate difference|1.59|STANDARD_ERROR_OF_MEAN|1.57||0.3134|TWO_SIDED|60.0|0.26|2.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||2.91|0.26|0.3134
71150516|NCT00658359|141793856|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.19|STANDARD_ERROR_OF_MEAN|3.61||0.2447|TWO_SIDED|60.0|-7.23|-1.16|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||-1.16|-7.23|0.2447
71150517|NCT00658359|141793856|SUPERIORITY_OR_OTHER||Estimated rate difference|1.59|STANDARD_ERROR_OF_MEAN|1.57||0.3134|TWO_SIDED|60.0|0.26|2.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||2.91|0.26|0.3134
71150518|NCT00658359|141793856|SUPERIORITY_OR_OTHER||Estimated rate difference|-7.44|STANDARD_ERROR_OF_MEAN|4.74||0.1164|TWO_SIDED|60.0|-11.43|-3.45|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||-3.45|-11.43|0.1164
71150519|NCT00658359|141793856|SUPERIORITY_OR_OTHER||Estimated rate difference|3.73|STANDARD_ERROR_OF_MEAN|2.62||0.1545|TWO_SIDED|60.0|1.52|5.93|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||5.93|1.52|0.1545
71150520|NCT00658359|141793856|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.3|STANDARD_ERROR_OF_MEAN|5.18||0.3061|TWO_SIDED|60.0|-9.66|-0.94|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||-0.94|-9.66|0.3061
71150521|NCT00658359|141793856|SUPERIORITY_OR_OTHER||Estimated rate difference|3.73|STANDARD_ERROR_OF_MEAN|2.62||0.1545|TWO_SIDED|60.0|1.52|5.93|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||5.93|1.52|0.1545
71150522|NCT00658359|141793856|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.3|STANDARD_ERROR_OF_MEAN|5.18||0.3061|TWO_SIDED|60.0|-9.66|-0.94|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||-0.94|-9.66|0.3061
71150523|NCT00658359|141793856|SUPERIORITY_OR_OTHER||Estimated rate difference|5.91|STANDARD_ERROR_OF_MEAN|3.35||0.0774|TWO_SIDED|60.0|3.1|8.73|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||8.73|3.10|0.0774
71150524|NCT00658359|141793856|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.12|STANDARD_ERROR_OF_MEAN|5.59||0.5772|TWO_SIDED|60.0|-7.82|1.59|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||1.59|-7.82|0.5772
71150525|NCT00658359|141793856|SUPERIORITY_OR_OTHER||Estimated rate difference|5.91|STANDARD_ERROR_OF_MEAN|3.35||0.0774|TWO_SIDED|60.0|3.1|8.73|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||8.73|3.10|0.0774
71150526|NCT00658359|141793856|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.12|STANDARD_ERROR_OF_MEAN|5.59||0.5772|TWO_SIDED|60.0|-7.82|1.59|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||1.59|-7.82|0.5772
71150527|NCT00658359|141793856|SUPERIORITY_OR_OTHER||Estimated rate difference|5.91|STANDARD_ERROR_OF_MEAN|3.35||0.0774|TWO_SIDED|60.0|3.1|8.73|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||8.73|3.10|0.0774
70956263|NCT02245737|141416123|SUPERIORITY||LS Mean Difference (Final Values)|1.77|STANDARD_ERROR_OF_MEAN|1.13||0.116|TWO_SIDED|95.0|-0.441|3.986|||Mixed Models Analysis|||||3.986|-0.441|0.116
70956264|NCT02245737|141416123|SUPERIORITY||LS Mean Difference (Final Values)|1.45|STANDARD_ERROR_OF_MEAN|1.15||0.208|TWO_SIDED|95.0|-0.808|3.704|||Mixed Models Analysis|||||3.704|-0.808|0.208
70956265|NCT02245737|141416124|SUPERIORITY||LS Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.36||0.379|TWO_SIDED|95.0|-0.391|1.027|||Mixed Models Analysis|||||1.027|-0.391|0.379
70956266|NCT02245737|141416124|SUPERIORITY||LS Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.37||0.992|TWO_SIDED|95.0|-0.714|0.721|||Mixed Models Analysis|||||0.721|-0.714|0.992
70956267|NCT02245737|141416125|SUPERIORITY||LS Mean Difference (Final Values)|-51.27|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-56.963|-45.578|||ANCOVA|||||-45.578|-56.963|<0.001
70956268|NCT02245737|141416125|SUPERIORITY||LS Mean Difference (Final Values)|-65.48|STANDARD_ERROR_OF_MEAN|2.77|<|0.001|TWO_SIDED|95.0|-70.947|-60.022|||ANCOVA|||||-60.022|-70.947|<0.001
70956269|NCT02245737|141416126|SUPERIORITY||LS Mean Difference (Final Values)|-57.99|STANDARD_ERROR_OF_MEAN|2.47|<|0.001|TWO_SIDED|95.0|-62.865|-53.108|||ANCOVA|||||-53.108|-62.865|<0.001
70956270|NCT02245737|141416126|SUPERIORITY||LS Mean Difference (Final Values)|-73.25|STANDARD_ERROR_OF_MEAN|2.37|<|0.001|TWO_SIDED|95.0|-77.926|-68.575|||ANCOVA|||||-68.575|-77.926|<0.001
71150528|NCT00658359|141793856|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.12|STANDARD_ERROR_OF_MEAN|5.59||0.5772|TWO_SIDED|60.0|-7.82|1.59|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||1.59|-7.82|0.5772
70956271|NCT02245737|141416127|SUPERIORITY||LS Mean Difference (Final Values)|-19.87|STANDARD_ERROR_OF_MEAN|11.33||0.081|TWO_SIDED|95.0|-42.21|2.464|||ANCOVA|||||2.464|-42.210|0.081
70956272|NCT02245737|141416127|SUPERIORITY||LS Mean Difference (Final Values)|-15.31|STANDARD_ERROR_OF_MEAN|10.78||0.157|TWO_SIDED|95.0|-36.555|5.938|||ANCOVA|||||5.938|-36.555|0.157
70956273|NCT02245737|141416128|SUPERIORITY||LS Mean Difference (Final Values)|-2.62|STANDARD_ERROR_OF_MEAN|1.33||0.05|TWO_SIDED|95.0|-5.243|-0.002|||ANCOVA|||||-0.002|-5.243|0.050
70956274|NCT02245737|141416128|SUPERIORITY||LS Mean Difference (Final Values)|-2.12|STANDARD_ERROR_OF_MEAN|1.27||0.095|TWO_SIDED|95.0|-4.618|0.373|||ANCOVA|||||0.373|-4.618|0.095
70956275|NCT02245737|141416129|SUPERIORITY||LS Mean Difference (Final Values)|-13.68|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-18.785|-8.574|||ANCOVA|||||-8.574|-18.785|<0.001
71150529|NCT00658359|141793856|SUPERIORITY_OR_OTHER||Estimated rate difference|5.91|STANDARD_ERROR_OF_MEAN|3.35||0.0774|TWO_SIDED|60.0|3.1|8.73|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||8.73|3.10|0.0774
71150530|NCT00658359|141793856|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.12|STANDARD_ERROR_OF_MEAN|5.59||0.5772|TWO_SIDED|60.0|-7.82|1.59|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||1.59|-7.82|0.5772
71150531|NCT00658359|141793858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.35|STANDARD_ERROR_OF_MEAN|8.15||0.0786|TWO_SIDED|60.0|7.49|21.22|||Mixed Models Analysis|||Month 15||21.22|7.49|0.0786
70956276|NCT02245737|141416129|SUPERIORITY||LS Mean Difference (Final Values)|-17.66|STANDARD_ERROR_OF_MEAN|2.66|<|0.001|TWO_SIDED|95.0|-22.887|-12.428|||ANCOVA|||||-12.428|-22.887|<0.001
70956277|NCT02245737|141416130|SUPERIORITY||LS Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.426|TWO_SIDED|95.0|-0.033|0.014|||ANCOVA|||||0.014|-0.033|0.426
70956278|NCT02245737|141416130|SUPERIORITY||LS Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.66|TWO_SIDED|95.0|-0.029|0.018|||ANCOVA|||||0.018|-0.029|0.660
70956279|NCT02245737|141416131|SUPERIORITY||LS Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.0||0.21|TWO_SIDED|95.0|-0.015|0.003|||ANCOVA|||||0.003|-0.015|0.210
70956280|NCT02245737|141416131|SUPERIORITY||LS Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.568|TWO_SIDED|95.0|-0.013|0.007|||ANCOVA|||||0.007|-0.013|0.568
70956281|NCT02245737|141416132|SUPERIORITY||LS Mean Difference (Final Values)|-2.34|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|-3.258|-1.413|||ANCOVA|||||-1.413|-3.258|<0.001
70956282|NCT02245737|141416132|SUPERIORITY||LS Mean Difference (Final Values)|-3.18|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|-4.118|-2.247|||ANCOVA|||||-2.247|-4.118|<0.001
70956283|NCT00618618|141416135|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.005|TWO_SIDED|95.0|-1.0|-0.2|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||-0.2|-1.0|0.005
70956284|NCT00618618|141416135|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9||||0.001|TWO_SIDED|95.0|-1.4|-0.4|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||-0.4|-1.4|0.001
70956285|NCT00618618|141416135|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.069|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||0.0|-0.8|0.069
70956286|NCT00618618|141416136|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8||||0.005|TWO_SIDED|95.0|0.6|3.0|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||3.0|0.6|0.005
70956287|NCT00618618|141416136|SUPERIORITY_OR_OTHER||LS Mean Difference|2.5||||0.001|TWO_SIDED|95.0|1.0|4.0|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||4.0|1.0|0.001
70956288|NCT00618618|141416136|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0||||0.122|TWO_SIDED|95.0|-0.3|2.2|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||2.2|-0.3|0.122
71150532|NCT00658359|141793858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.87|STANDARD_ERROR_OF_MEAN|8.5||0.736|TWO_SIDED|60.0|-10.03|4.29|||Mixed Models Analysis|||Month 15||4.29|-10.03|0.7360
70876101|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|0.45|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|-0.04|0.94||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.94|-0.04|
70876102|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|1.79|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|1.26|2.31||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||2.31|1.26|
70876103|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|0.06|1.11||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.11|0.06|
70876104|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|0.64|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|0.11|1.17||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.17|0.11|
70876105|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|0.11|1.15||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.15|0.11|
70876106|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|1.87|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|1.33|2.4||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||2.40|1.33|
70876107|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.07|1.05||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.05|-0.07|
70876108|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|90.0|-0.24|0.91||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.91|-0.24|
70876109|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.13|0.98||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.98|-0.13|
70876110|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|1.61|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|1.05|2.17||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||2.17|1.05|
70876111|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|90.0|-0.74|0.64||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.64|-0.74|
70876112|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|90.0|-0.86|0.56||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.56|-0.86|
70876113|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|90.0|-0.57|0.8||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.80|-0.57|
70876114|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|90.0|0.22|1.58||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.58|0.22|
70876115|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|90.0|-0.93|0.59||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.59|-0.93|
70876116|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|90.0|-0.98|0.62||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.62|-0.98|
70956289|NCT00618618|141416137|SUPERIORITY_OR_OTHER||Difference from Placebo|38.3||||0.008|TWO_SIDED|95.0|11.0|65.7|||Fisher Exact|||||65.7|11.0|0.008
70956290|NCT00618618|141416137|SUPERIORITY_OR_OTHER||Difference from Placebo|32.9||||0.172|TWO_SIDED|95.0|1.0|64.8|||Fisher Exact|||||64.8|1.0|0.172
70956291|NCT00618618|141416137|SUPERIORITY_OR_OTHER||Difference from Placebo|22.9||||0.252|TWO_SIDED|95.0|-8.4|54.2|||Fisher Exact|||||54.2|-8.4|0.252
70956292|NCT00618618|141416138|SUPERIORITY_OR_OTHER||Difference from Placebo|46.1||||0.011|TWO_SIDED|95.0|16.3|75.9|||Fisher Exact|||||75.9|16.3|0.011
70956293|NCT00618618|141416138|SUPERIORITY_OR_OTHER||Difference from Placebo|54.3||||0.013|TWO_SIDED|95.0|23.0|85.5|||Fisher Exact|||||85.5|23.0|0.013
70956294|NCT00618618|141416138|SUPERIORITY_OR_OTHER||Difference from Placebo|24.3||||0.296|TWO_SIDED|95.0|-8.7|57.3|||Fisher Exact|||||57.3|-8.7|0.296
70956295|NCT00618618|141416139|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.46|TWO_SIDED|95.0|-0.5|0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.2|-0.5|0.460
70956296|NCT00618618|141416139|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.906|TWO_SIDED|95.0|-0.5|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.4|-0.5|0.906
70956297|NCT00618618|141416139|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.404|TWO_SIDED|95.0|-0.6|0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.2|-0.6|0.404
70956298|NCT00618618|141416139|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.791|TWO_SIDED|95.0|-0.5|0.3|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.3|-0.5|0.791
70956299|NCT00618618|141416139|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.41|TWO_SIDED|95.0|-0.3|0.6|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.6|-0.3|0.410
70956300|NCT00618618|141416139|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.733|TWO_SIDED|95.0|-0.3|0.5|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.5|-0.3|0.733
71150533|NCT00658359|141793858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.16|STANDARD_ERROR_OF_MEAN|8.19||0.1377|TWO_SIDED|60.0|5.27|19.05|||Mixed Models Analysis|||Month 18||19.05|5.27|0.1377
70876117|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|90.0|-1.05|0.45||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.45|-1.05|
70956301|NCT00618618|141416139|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.542|TWO_SIDED|95.0|-0.3|0.5|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.5|-0.3|0.542
70956302|NCT00618618|141416139|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.882|TWO_SIDED|95.0|-0.4|0.5|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.5|-0.4|0.882
70956303|NCT00618618|141416139|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.934|TWO_SIDED|95.0|-0.4|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.4|-0.4|0.934
70956304|NCT00618618|141416139|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.838|TWO_SIDED|95.0|-0.4|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.4|-0.4|0.838
70956305|NCT00618618|141416139|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.777|TWO_SIDED|95.0|-0.5|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.4|-0.5|0.777
70956306|NCT00618618|141416139|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.795|TWO_SIDED|95.0|-0.4|0.5|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.5|-0.4|0.795
70956307|NCT00618618|141416139|SUPERIORITY_OR_OTHER||LS mean Difference|0.0||||0.852|TWO_SIDED|95.0|-0.4|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||0.4|-0.4|0.852
70956308|NCT00618618|141416139|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.444|TWO_SIDED|95.0|-0.6|0.3|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||0.3|-0.6|0.444
70956309|NCT00618618|141416139|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.724|TWO_SIDED|95.0|-0.3|0.5|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||0.5|-0.3|0.724
70956310|NCT00618618|141416140|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.934|TWO_SIDED|95.0|-0.4|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.4|-0.4|0.934
70956311|NCT00618618|141416140|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.286|TWO_SIDED|95.0|-0.7|0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.2|-0.7|0.286
70956312|NCT00618618|141416140|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.19|TWO_SIDED|95.0|-0.1|0.7|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.7|-0.1|0.190
71150534|NCT00658359|141793858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.01|STANDARD_ERROR_OF_MEAN|8.56||0.4131|TWO_SIDED|60.0|-14.21|0.2|||Mixed Models Analysis|||Month 18||0.20|-14.21|0.4131
71150535|NCT00658359|141793858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.52|STANDARD_ERROR_OF_MEAN|8.35||0.1057|TWO_SIDED|60.0|6.49|20.55|||Mixed Models Analysis|||Month 24||20.55|6.49|0.1057
71150536|NCT00658359|141793858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.21|STANDARD_ERROR_OF_MEAN|8.95||0.1402|TWO_SIDED|60.0|-20.75|-5.68|||Mixed Models Analysis|||Month 24||-5.68|-20.75|0.1402
70876118|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|90.0|-0.47|1.02||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.02|-0.47|
71150537|NCT00658359|141793858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.6|STANDARD_ERROR_OF_MEAN|9.13||0.0542|TWO_SIDED|60.0|9.91|25.29|||Mixed Models Analysis|||Month 30||25.29|9.91|0.0542
71150538|NCT00658359|141793858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.74|STANDARD_ERROR_OF_MEAN|10.09||0.3866|TWO_SIDED|60.0|0.24|17.24|||Mixed Models Analysis|||Month 30||17.24|0.24|0.3866
71150539|NCT00658359|141793858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.52|STANDARD_ERROR_OF_MEAN|9.72||0.1981|TWO_SIDED|60.0|4.33|20.71|||Mixed Models Analysis|||Month 36||20.71|4.33|0.1981
71150540|NCT00658359|141793858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.65|STANDARD_ERROR_OF_MEAN|12.07||0.6397|TWO_SIDED|60.0|-15.81|4.51|||Mixed Models Analysis|||Month 36||4.51|-15.81|0.6397
71150541|NCT00658359|141793858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.93|STANDARD_ERROR_OF_MEAN|10.19||0.0508|TWO_SIDED|60.0|11.35|28.51|||Mixed Models Analysis|||Month 42||28.51|11.35|0.0508
71150542|NCT00658359|141793858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.42|STANDARD_ERROR_OF_MEAN|12.9||0.5143|TWO_SIDED|60.0|-2.45|19.28|||Mixed Models Analysis|||Month 42||19.28|-2.45|0.5143
71150543|NCT00658359|141793858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.26|STANDARD_ERROR_OF_MEAN|10.45||0.0021|TWO_SIDED|60.0|23.46|41.06|||Mixed Models Analysis|||Month 48||41.06|23.46|0.0021
71150544|NCT00658359|141793858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.73|STANDARD_ERROR_OF_MEAN|13.47||0.5661|TWO_SIDED|60.0|-19.07|3.61|||Mixed Models Analysis|||Month 48||3.61|-19.07|0.5661
71150545|NCT00658359|141793858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.2|STANDARD_ERROR_OF_MEAN|10.54||0.0057|TWO_SIDED|60.0|20.33|38.08|||Mixed Models Analysis|||Month 54||38.08|20.33|0.0057
71150546|NCT00658359|141793858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.49|STANDARD_ERROR_OF_MEAN|13.89||0.4504|TWO_SIDED|60.0|-22.18|1.21|||Mixed Models Analysis|||Month 54||1.21|-22.18|0.4504
71150547|NCT00658359|141793858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.37|STANDARD_ERROR_OF_MEAN|11.39||0.0078|TWO_SIDED|60.0|20.78|39.96|||Mixed Models Analysis|||Month 60||39.96|20.78|0.0078
71150548|NCT00658359|141793858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.95|STANDARD_ERROR_OF_MEAN|14.44||0.6802|TWO_SIDED|60.0|-18.11|6.2|||Mixed Models Analysis|||Month 60||6.20|-18.11|0.6802
71150549|NCT00658359|141793858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.78|STANDARD_ERROR_OF_MEAN|12.08||0.0216|TWO_SIDED|60.0|17.61|37.95|||Mixed Models Analysis|||Month 66||37.95|17.61|0.0216
71150550|NCT00658359|141793858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.85|STANDARD_ERROR_OF_MEAN|15.12||0.9026|TWO_SIDED|60.0|-14.58|10.88|||Mixed Models Analysis|||Month 66||10.88|-14.58|0.9026
71150551|NCT00658359|141793858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.38|STANDARD_ERROR_OF_MEAN|12.91||0.1146|TWO_SIDED|60.0|9.51|31.24|||Mixed Models Analysis|||Month 72||31.24|9.51|0.1146
71150552|NCT00658359|141793858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.14|STANDARD_ERROR_OF_MEAN|15.48||0.6918|TWO_SIDED|60.0|-19.18|6.9|||Mixed Models Analysis|||Month 72||6.90|-19.18|0.6918
71150553|NCT00658359|141793859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.62|STANDARD_ERROR_OF_MEAN|6.57||0.3139|TWO_SIDED|60.0|1.09|12.14|||Mixed Models Analysis|||Month 15||12.14|1.09|0.3139
71150554|NCT00658359|141793859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.37|STANDARD_ERROR_OF_MEAN|6.75||0.5176|TWO_SIDED|60.0|-10.06|1.31|||Mixed Models Analysis|||Month 15||1.31|-10.06|0.5176
71150555|NCT00658359|141793859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.54|STANDARD_ERROR_OF_MEAN|6.56||0.3191|TWO_SIDED|60.0|1.02|12.06|||Mixed Models Analysis|||Month 18||12.06|1.02|0.3191
71150556|NCT00658359|141793859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.95|STANDARD_ERROR_OF_MEAN|6.73||0.6608|TWO_SIDED|60.0|-8.62|2.71|||Mixed Models Analysis|||Month 18||2.71|-8.62|0.6608
71150557|NCT00658359|141793859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.02|STANDARD_ERROR_OF_MEAN|6.7||0.2319|TWO_SIDED|60.0|2.37|13.66|||Mixed Models Analysis|||Month 24||13.66|2.37|0.2319
71150558|NCT00658359|141793859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5|STANDARD_ERROR_OF_MEAN|7.04||0.3554|TWO_SIDED|60.0|-12.43|-0.58|||Mixed Models Analysis|||Month 24||-0.58|-12.43|0.3554
71150559|NCT00658359|141793859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.45|STANDARD_ERROR_OF_MEAN|7.27||0.0113|TWO_SIDED|60.0|12.33|24.57|||Mixed Models Analysis|||Month 30||24.57|12.33|0.0113
71150560|NCT00658359|141793859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.66|STANDARD_ERROR_OF_MEAN|7.99||0.479|TWO_SIDED|60.0|-1.07|12.39|||Mixed Models Analysis|||Month 30||12.39|-1.07|0.4790
71150561|NCT00658359|141793859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.46|STANDARD_ERROR_OF_MEAN|7.75||0.1776|TWO_SIDED|60.0|3.93|16.99|||Mixed Models Analysis|||Month 36||16.99|3.93|0.1776
71150562|NCT00658359|141793859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.27|STANDARD_ERROR_OF_MEAN|9.5||0.7307|TWO_SIDED|60.0|-11.27|4.73|||Mixed Models Analysis|||Month 36||4.73|-11.27|0.7307
71150563|NCT00658359|141793859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.53|STANDARD_ERROR_OF_MEAN|8.25||0.1625|TWO_SIDED|60.0|4.59|18.48|||Mixed Models Analysis|||Month 42||18.48|4.59|0.1625
71150564|NCT00658359|141793859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.77|STANDARD_ERROR_OF_MEAN|10.12||0.2876|TWO_SIDED|60.0|2.25|19.29|||Mixed Models Analysis|||Month 42||19.29|2.25|0.2876
71150565|NCT00658359|141793859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.62|STANDARD_ERROR_OF_MEAN|8.41||0.027|TWO_SIDED|60.0|11.54|25.7|||Mixed Models Analysis|||Month 48||25.70|11.54|0.0270
71150566|NCT00658359|141793859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|10.54||0.7444|TWO_SIDED|60.0|-12.31|5.44|||Mixed Models Analysis|||Month 48||5.44|-12.31|0.7444
71150567|NCT00658359|141793859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.18|STANDARD_ERROR_OF_MEAN|8.44||0.0122|TWO_SIDED|60.0|14.08|28.29|||Mixed Models Analysis|||Month 54||28.29|14.08|0.0122
71150568|NCT00658359|141793859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.61|STANDARD_ERROR_OF_MEAN|10.86||0.3288|TWO_SIDED|60.0|-19.75|-1.47|||Mixed Models Analysis|||Month 54||-1.47|-19.75|0.3288
70956313|NCT00618618|141416140|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.402|TWO_SIDED|95.0|-0.5|0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.2|-0.5|0.402
70956314|NCT00618618|141416140|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.29|TWO_SIDED|95.0|-0.7|0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.2|-0.7|0.290
70956315|NCT00618618|141416140|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.863|TWO_SIDED|95.0|-0.4|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.4|-0.4|0.863
70956316|NCT00618618|141416140|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.128|TWO_SIDED|95.0|-0.7|0.1|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.1|-0.7|0.128
70956317|NCT00618618|141416140|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.018|TWO_SIDED|95.0|-0.9|-0.1|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||-0.1|-0.9|0.018
70956318|NCT00618618|141416140|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.489|TWO_SIDED|95.0|-0.5|0.3|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.3|-0.5|0.489
70956319|NCT00618618|141416140|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.007|TWO_SIDED|95.0|-0.9|-0.1|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||-0.1|-0.9|0.007
70956320|NCT00618618|141416140|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|||<|0.001|TWO_SIDED|95.0|-1.3|-0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||-0.4|-1.3|<0.001
70956321|NCT00618618|141416140|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.122|TWO_SIDED|95.0|-0.7|0.1|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.1|-0.7|0.122
70956322|NCT00618618|141416140|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.005|TWO_SIDED|95.0|-0.9|-0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||-0.2|-0.9|0.005
70956323|NCT00618618|141416140|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|||<|0.001|TWO_SIDED|95.0|-1.2|-0.3|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||-0.3|-1.2|<0.001
70956324|NCT00618618|141416140|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.007|TWO_SIDED|95.0|-1.0|-0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||-0.2|-1.0|0.007
70956325|NCT00618618|141416142|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9||||0.573|TWO_SIDED|95.0|-8.6|4.8|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||4.8|-8.6|0.573
70956326|NCT00618618|141416142|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8||||0.653|TWO_SIDED|95.0|-6.3|9.9|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||9.9|-6.3|0.653
70956327|NCT00618618|141416142|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4||||0.688|TWO_SIDED|95.0|-5.4|8.1|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||8.1|-5.4|0.688
70956328|NCT02929329|141416147|SUPERIORITY|"The overall type I error was 0.05 for 2-sided testing across primary and secondary outcomes.~Control for multiple comparisons was achieved using the following testing algorithm: if the primary outcome met the P-value threshold of 0.05, the alpha error would be divided unequally between cardiovascular death (96% of the overall alpha error, or 0.048) and change from baseline to week 24 in the Kansas City Cardiomyopathy Questionnaire total symptom score (4% of the overall alpha error, or 0.002)."|Hazard Ratio (HR)|0.92||||0.0252|TWO_SIDED|95.0|0.86|0.99|||Regression, Cox|Stratified by randomization setting and region, including terms for baseline estimated glomerular filtration rate (eGFR) and treatment group.|Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the treatment group and baseline eGFR as covariates.|||0.99|0.86|0.0252
70956329|NCT02929329|141416147|SUPERIORITY|||||||0.0211|||||||Stratified log-rank test|Log-rank test stratified by randomization setting and region.||||||0.0211
71150569|NCT00658359|141793859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.34|STANDARD_ERROR_OF_MEAN|9.15||0.0453|TWO_SIDED|60.0|10.63|26.05|||Mixed Models Analysis|||Month 60||26.05|10.63|0.0453
71150570|NCT00658359|141793859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.59|STANDARD_ERROR_OF_MEAN|11.28||0.5016|TWO_SIDED|60.0|-17.09|1.91|||Mixed Models Analysis|||Month 60||1.91|-17.09|0.5016
71150571|NCT00658359|141793859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.43|STANDARD_ERROR_OF_MEAN|9.69||0.0453|TWO_SIDED|60.0|11.27|27.59|||Mixed Models Analysis|||Month 66||27.59|11.27|0.0453
71150572|NCT00658359|141793859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.87|STANDARD_ERROR_OF_MEAN|11.84||0.8747|TWO_SIDED|60.0|-11.83|8.1|||Mixed Models Analysis|||Month 66||8.10|-11.83|0.8747
71150573|NCT00658359|141793859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.98|STANDARD_ERROR_OF_MEAN|10.34||0.4997|TWO_SIDED|60.0|-1.72|15.69|||Mixed Models Analysis|||Month 72||15.69|-1.72|0.4997
71150574|NCT00658359|141793859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.07|STANDARD_ERROR_OF_MEAN|12.1||0.2804|TWO_SIDED|60.0|-23.26|-2.88|||Mixed Models Analysis|||Month 72||-2.88|-23.26|0.2804
71150575|NCT00658359|141793860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.79|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|60.0|7.68|11.9|||Mixed Models Analysis|||Month 15||11.90|7.68|<0.0001
71150576|NCT00658359|141793860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.32|STANDARD_ERROR_OF_MEAN|2.61||0.0418|TWO_SIDED|60.0|3.12|7.52|||Mixed Models Analysis|||Month 15||7.52|3.12|0.0418
71150577|NCT00658359|141793860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.4|STANDARD_ERROR_OF_MEAN|2.51||0.0002|TWO_SIDED|60.0|7.28|11.51|||Mixed Models Analysis|||Month 18||11.51|7.28|0.0002
71150578|NCT00658359|141793860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3|STANDARD_ERROR_OF_MEAN|2.63||0.0437|TWO_SIDED|60.0|3.09|7.51|||Mixed Models Analysis|||Month 18||7.51|3.09|0.0437
71150579|NCT00658359|141793860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.37|STANDARD_ERROR_OF_MEAN|2.56||0.0011|TWO_SIDED|60.0|6.21|10.53|||Mixed Models Analysis|||Month 24||10.53|6.21|0.0011
71150580|NCT00658359|141793860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.04|STANDARD_ERROR_OF_MEAN|2.75||0.4565|TWO_SIDED|60.0|-0.27|4.36|||Mixed Models Analysis|||Month 24||4.36|-0.27|0.4565
71150581|NCT00658359|141793860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.9|STANDARD_ERROR_OF_MEAN|2.8||0.0001|TWO_SIDED|60.0|8.54|13.26|||Mixed Models Analysis|||Month 30||13.26|8.54|0.0001
71150582|NCT00658359|141793860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.29|STANDARD_ERROR_OF_MEAN|3.09||0.1654|TWO_SIDED|60.0|1.69|6.89|||Mixed Models Analysis|||Month 30||6.89|1.69|0.1654
71150583|NCT00658359|141793860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.45|STANDARD_ERROR_OF_MEAN|2.98||0.0015|TWO_SIDED|60.0|6.95|11.96|||Mixed Models Analysis|||Month 36||11.96|6.95|0.0015
71150584|NCT00658359|141793860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.13|STANDARD_ERROR_OF_MEAN|3.69||0.2636|TWO_SIDED|60.0|1.02|7.23|||Mixed Models Analysis|||Month 36||7.23|1.02|0.2636
71150585|NCT00658359|141793860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.08|STANDARD_ERROR_OF_MEAN|3.12||0.052|TWO_SIDED|60.0|3.45|8.71|||Mixed Models Analysis|||Month 42||8.71|3.45|0.0520
71150586|NCT00658359|141793860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.35|STANDARD_ERROR_OF_MEAN|3.95||0.176|TWO_SIDED|60.0|2.02|8.67|||Mixed Models Analysis|||Month 42||8.67|2.02|0.1760
71150587|NCT00658359|141793860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.08|STANDARD_ERROR_OF_MEAN|3.2||0.0274|TWO_SIDED|60.0|4.38|9.77|||Mixed Models Analysis|||Month 48||9.77|4.38|0.0274
71150588|NCT00658359|141793860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|4.13||0.8018|TWO_SIDED|60.0|-4.51|2.44|||Mixed Models Analysis|||Month 48||2.44|-4.51|0.8018
71150589|NCT00658359|141793860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.63|STANDARD_ERROR_OF_MEAN|3.23||0.0819|TWO_SIDED|60.0|2.91|8.35|||Mixed Models Analysis|||Month 54||8.35|2.91|0.0819
71150590|NCT00658359|141793860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.17|STANDARD_ERROR_OF_MEAN|4.26||0.6103|TWO_SIDED|60.0|-5.75|1.41|||Mixed Models Analysis|||Month 54||1.41|-5.75|0.6103
71150591|NCT00658359|141793860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.48|STANDARD_ERROR_OF_MEAN|3.49||0.1168|TWO_SIDED|60.0|2.54|8.41|||Mixed Models Analysis|||Month 60||8.41|2.54|0.1168
71150592|NCT00658359|141793860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.26|STANDARD_ERROR_OF_MEAN|4.43||0.3357|TWO_SIDED|60.0|0.54|7.99|||Mixed Models Analysis|||Month 60||7.99|0.54|0.3357
71150593|NCT00658359|141793860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.42|STANDARD_ERROR_OF_MEAN|3.7||0.0448|TWO_SIDED|60.0|4.31|10.54|||Mixed Models Analysis|||Month 66||10.54|4.31|0.0448
71150594|NCT00658359|141793860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|STANDARD_ERROR_OF_MEAN|4.64||0.7642|TWO_SIDED|60.0|-2.51|5.29|||Mixed Models Analysis|||Month 66||5.29|-2.51|0.7642
71150595|NCT00658359|141793860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.99|STANDARD_ERROR_OF_MEAN|3.95||0.1295|TWO_SIDED|60.0|2.67|9.32|||Mixed Models Analysis|||Month 72||9.32|2.67|0.1295
71150596|NCT00658359|141793860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.13|STANDARD_ERROR_OF_MEAN|4.75||0.654|TWO_SIDED|60.0|-1.87|6.13|||Mixed Models Analysis|||Month 72||6.13|-1.87|0.6540
71150597|NCT00658359|141793861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.11|STANDARD_ERROR_OF_MEAN|19.53||0.7543|TWO_SIDED|60.0|-22.55|10.33|||Mixed Models Analysis|||Month 15||10.33|-22.55|0.7543
71150598|NCT00658359|141793861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.95|STANDARD_ERROR_OF_MEAN|20.33||0.6249|TWO_SIDED|60.0|-27.07|7.17|||Mixed Models Analysis|||Month 15||7.17|-27.07|0.6249
71150599|NCT00658359|141793861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.66|STANDARD_ERROR_OF_MEAN|19.61||0.3415|TWO_SIDED|60.0|-35.17|-2.15|||Mixed Models Analysis|||Month 18||-2.15|-35.17|0.3415
71150600|NCT00658359|141793861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.86|STANDARD_ERROR_OF_MEAN|20.47||0.072|TWO_SIDED|60.0|-54.1|-19.63|||Mixed Models Analysis|||Month 18||-19.63|-54.10|0.0720
71150601|NCT00658359|141793861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.0|STANDARD_ERROR_OF_MEAN|19.99||0.2937|TWO_SIDED|60.0|-37.83|-4.17|||Mixed Models Analysis|||Month 24||-4.17|-37.83|0.2937
71150602|NCT00658359|141793861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.72|STANDARD_ERROR_OF_MEAN|21.38||0.0512|TWO_SIDED|60.0|-59.72|-23.73|||Mixed Models Analysis|||Month 24||-23.73|-59.72|0.0512
71150603|NCT00658359|141793861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-45.43|STANDARD_ERROR_OF_MEAN|21.76||0.037|TWO_SIDED|60.0|-63.75|-27.11|||Mixed Models Analysis|||Month 30||-27.11|-63.75|0.0370
71150604|NCT00658359|141793861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.92|STANDARD_ERROR_OF_MEAN|24.0||0.8701|TWO_SIDED|60.0|-24.13|16.28|||Mixed Models Analysis|||Month 30||16.28|-24.13|0.8701
70956330|NCT02929329|141416147|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.86|0.99|||||Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the treatment group and baseline eGFR as covariates.|Competing risk subdistribution hazard ratio and associated 95% confidence intervals for treatment were computed. Deaths not included in the endpoint were considered as the competing risk.||0.99|0.86|
71150605|NCT00658359|141793861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.75|STANDARD_ERROR_OF_MEAN|23.15||0.2146|TWO_SIDED|60.0|-48.24|-9.25|||Mixed Models Analysis|||Month 36||-9.25|-48.24|0.2146
71150606|NCT00658359|141793861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.03|STANDARD_ERROR_OF_MEAN|28.58||0.462|TWO_SIDED|60.0|-45.09|3.03|||Mixed Models Analysis|||Month 36||3.03|-45.09|0.4620
71150607|NCT00658359|141793861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.16|STANDARD_ERROR_OF_MEAN|24.28||0.8639|TWO_SIDED|60.0|-16.28|24.6|||Mixed Models Analysis|||Month 42||24.60|-16.28|0.8639
71150608|NCT00658359|141793861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.3|STANDARD_ERROR_OF_MEAN|30.65||0.323|TWO_SIDED|60.0|-56.11|-4.5|||Mixed Models Analysis|||Month 42||-4.50|-56.11|0.3230
71150609|NCT00658359|141793861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.49|STANDARD_ERROR_OF_MEAN|24.92||0.2214|TWO_SIDED|60.0|9.51|51.47|||Mixed Models Analysis|||Month 48||51.47|9.51|0.2214
71150610|NCT00658359|141793861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.25|STANDARD_ERROR_OF_MEAN|32.08||0.7492|TWO_SIDED|60.0|-37.26|16.75|||Mixed Models Analysis|||Month 48||16.75|-37.26|0.7492
71150611|NCT00658359|141793861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.61|STANDARD_ERROR_OF_MEAN|25.15||0.8236|TWO_SIDED|60.0|-15.57|26.79|||Mixed Models Analysis|||Month 54||26.79|-15.57|0.8236
71150612|NCT00658359|141793861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.67|STANDARD_ERROR_OF_MEAN|33.1||0.6578|TWO_SIDED|60.0|-13.2|42.54|||Mixed Models Analysis|||Month 54||42.54|-13.20|0.6578
71150613|NCT00658359|141793861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.93|STANDARD_ERROR_OF_MEAN|27.12||0.5326|TWO_SIDED|60.0|-5.9|39.76|||Mixed Models Analysis|||Month 60||39.76|-5.90|0.5326
71150614|NCT00658359|141793861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.0|STANDARD_ERROR_OF_MEAN|34.44||0.6845|TWO_SIDED|60.0|-42.99|15.0|||Mixed Models Analysis|||Month 60||15.00|-42.99|0.6845
71150615|NCT00658359|141793861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.35|STANDARD_ERROR_OF_MEAN|28.73||0.7713|TWO_SIDED|60.0|-15.83|32.54|||Mixed Models Analysis|||Month 66||32.54|-15.83|0.7713
71150616|NCT00658359|141793861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.11|STANDARD_ERROR_OF_MEAN|36.06||0.8438|TWO_SIDED|60.0|-37.47|23.26|||Mixed Models Analysis|||Month 66||23.26|-37.47|0.8438
71150617|NCT00658359|141793861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.06|STANDARD_ERROR_OF_MEAN|30.7||0.4724|TWO_SIDED|60.0|-3.78|47.91|||Mixed Models Analysis|||Month 72||47.91|-3.78|0.4724
71150618|NCT00658359|141793861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.25|STANDARD_ERROR_OF_MEAN|36.98||0.6218|TWO_SIDED|60.0|-12.89|49.38|||Mixed Models Analysis|||Month 72||49.38|-12.89|0.6218
70956331|NCT02929329|141416148|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.8555|TWO_SIDED|95.0|0.92|1.11||If significance for the primary outcome was determined, cardiovascular death was tested against an alpha of 0.048.|Regression, Cox|Stratified by randomization setting and region, including terms for baseline eGFR and treatment group.|Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the treatment group and baseline eGFR as covariates.|||1.11|0.92|0.8555
70956332|NCT02929329|141416148|SUPERIORITY||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.92|1.11|||||Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the treatment group and baseline eGFR as covariates.|Competing risk subdistribution hazard ratio and associated 95% confidence intervals for treatment were computed. Deaths not included in the endpoint were considered as the competing risk.||1.11|0.92|
70956333|NCT02929329|141416149|OTHER||Least Squares (LS) Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|95.0|-1.4|0.48|||||Treatment difference = Omecamtiv mecarbil - Placebo|||0.48|-1.40|
70956334|NCT02929329|141416149|OTHER||LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|0.54|4.46|||||Treatment difference = Omecamtiv mecarbil - Placebo|||4.46|0.54|
70956335|NCT02929329|141416149|SUPERIORITY|If significance for the primary outcome was determined, change from baseline in the KCCQ total symptom score was tested against an alpha of 0.002.||||||0.0278|||||||Omnibus F-test|||||||0.0278
70956336|NCT02929329|141416149|OTHER||Pooled treatment difference|0.75|||||TWO_SIDED|95.0|-2.55|4.51|||||Overall pooled estimate of treatment difference (Omecamtiv mecarbil - Placebo) using random effects meta-analysis approach.|||4.51|-2.55|
70956337|NCT02929329|141416149|SUPERIORITY||LS Mean Difference|-0.71|||||TWO_SIDED|95.0|-1.62|0.2|||||Treatment difference = Omecamtiv mecarbil - Placebo|As a sensitivity for missing data due to death, joint longitudinal and survival models were fit using KCCQ TSS observed values with random subject slopes and intercepts for the longitudinal models with terms for baseline eGFR, region, and treatment by slope. The survival models were fit for all-cause death with baseline eGFR and treatment in the proportional hazard part of the models, KCCQ TSS modeled values as the shared parameterization, stratified by region with Weibull baseline functions.||0.20|-1.62|
70956338|NCT02929329|141416149|SUPERIORITY||LS mean difference|2.31|||||TWO_SIDED|95.0|0.8|3.82|||||Treatment difference = Omecamtiv mecarbil - Placebo|As a sensitivity for missing data due to death, joint longitudinal and survival models were fit using KCCQ TSS observed values with random subject slopes and intercepts for the longitudinal models with terms for baseline eGFR, region, and treatment by slope. The survival models were fit for all-cause death with baseline eGFR and treatment in the proportional hazard part of the models, KCCQ TSS modeled values as the shared parameterization, stratified by region with Weibull baseline functions.||3.82|0.80|
71150619|NCT00658359|141793865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33|STANDARD_ERROR_OF_MEAN|7.93||0.7693|TWO_SIDED|60.0|-9.01|4.35|||Mixed Models Analysis|||Month 15||4.35|-9.01|0.7693
70956339|NCT02929329|141416150|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.1902|TWO_SIDED|95.0|0.87|1.03||If statistical significance was achieved for both the time to CV death and change from baseline in the KCCQ TSS, time to first heart failure hospitalization was to be tested at the full alpha.|Regression, Cox|Stratified by randomization setting and region, including terms for baseline eGFR and treatment group.|Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the trial group and the baseline eGFR as covariates.|||1.03|0.87|0.1902
70956340|NCT02929329|141416150|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.88|1.04|||||Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the trial group and the baseline eGFR as covariates.|Competing risk subdistribution hazard ratio and associated 95% confidence intervals for treatment were computed. Deaths not included in the endpoint are considered as the competing risk.||1.04|0.88|
70956341|NCT02929329|141416151|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9633|TWO_SIDED|95.0|0.92|1.09||If time to first heart failure hospitalization was statistically significant, time to all-cause death was to be tested with the same alpha as time to first heart failure hospitalization.|Regression, Cox||Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the trial group and the baseline eGFR as covariates.|||1.09|0.92|0.9633
70956342|NCT00560560|141416172|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||The final analysis was intended to be a binomial test (death prior to 6 months, yes or no). However, 2 participants in the 30/kg mg group were censored prior to 6 months, so the six month Kaplan and Meier estimates were used for each group instead.|Test of probability of 6 month survival|p-Value \>0.05 applies to each group (20 mg/kg and 30 mg/kg). Greenwood's formula was used for standard deviation.||The hypotheses for each group were H0:p=0.45 vs H1:p\>0.45. There was one interim analysis for futility for each group based on the method of Case and Morgan. The futility boundary was not crossed for 20/kg mg group, but was crossed for the 30/kg mg group. It was recommended to investigators that participants be discontinued from treatment with 30 mg/kg of figitumumab.||||>0.05
70956343|NCT00768079|141416204|SUPERIORITY_OR_OTHER_LEGACY|||||||0.312|||||||Fisher Exact|||Non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||0.312
70876119|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|0.15|1.11||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.11|0.15|
70956344|NCT00768079|141416204|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||1.000
70956345|NCT00768079|141416204|SUPERIORITY_OR_OTHER_LEGACY|||||||0.312|||||||Fisher Exact|||Adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||0.312
70956346|NCT00768079|141416204|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||1.000
71150620|NCT00658359|141793865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.75|STANDARD_ERROR_OF_MEAN|8.28||0.7396|TWO_SIDED|60.0|-4.22|9.73|||Mixed Models Analysis|||Month 15||9.73|-4.22|0.7396
71150621|NCT00658359|141793865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.84|STANDARD_ERROR_OF_MEAN|7.92||0.3881|TWO_SIDED|60.0|-13.51|-0.17|||Mixed Models Analysis|||Month 18||-0.17|-13.51|0.3881
70956347|NCT00768079|141416206|SUPERIORITY_OR_OTHER_LEGACY|||||||0.343|||||||Fisher Exact|||Week 4, non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||0.343
70956348|NCT00768079|141416206|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Week 4, non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||1.000
70956349|NCT00768079|141416206|SUPERIORITY_OR_OTHER_LEGACY|||||||0.343|||||||Fisher Exact|||Week 4, adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||0.343
70956350|NCT00768079|141416206|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Week 4, adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||1.000
70956351|NCT00768079|141416206|SUPERIORITY_OR_OTHER_LEGACY|||||||0.474|||||||Fisher Exact|||Week 24, non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||0.474
70956352|NCT00768079|141416206|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Week 24, non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||1.000
70956353|NCT00768079|141416206|SUPERIORITY_OR_OTHER_LEGACY|||||||0.474|||||||Fisher Exact|||Week 24, adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||0.474
70956354|NCT00768079|141416206|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Week 24, adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||1.000
70956355|NCT01131182|141416294|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||95.0||||Assessed for relative risk using prior therapy (monotherapy or combination therapy) as a stratification factor.|Cochran-Mantel-Haenszel|||||||0.0005
70956356|NCT00662818|141416303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.329|TWO_SIDED|95.0|0.62|4.25|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.||||4.25|0.62|0.329
70956357|NCT00662818|141416304|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.42|TWO_SIDED|95.0|0.59|3.5|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.||||3.50|0.59|0.420
71150622|NCT00658359|141793865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.44|STANDARD_ERROR_OF_MEAN|8.28||0.5114|TWO_SIDED|60.0|-12.42|1.53|||Mixed Models Analysis|||Month 18||1.53|-12.42|0.5114
70956358|NCT00662818|141416308|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.648|TWO_SIDED|95.0|0.52|2.85|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.||||2.85|0.52|0.648
70956359|NCT00662818|141416309|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.647|TWO_SIDED|95.0|0.31|2.07|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.||||2.07|0.31|0.647
70956360|NCT00662818|141416310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.201|TWO_SIDED|95.0|0.73|4.6|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.||||4.60|0.73|0.201
70956361|NCT00662818|141416311|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.579|TWO_SIDED|95.0|0.47|3.85|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.||||3.85|0.47|0.579
71150623|NCT00658359|141793865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.43|STANDARD_ERROR_OF_MEAN|8.06||0.5829|TWO_SIDED|60.0|-11.21|2.36|||Mixed Models Analysis|||Month 24||2.36|-11.21|0.5829
71150624|NCT00658359|141793865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.76|STANDARD_ERROR_OF_MEAN|8.58||0.2559|TWO_SIDED|60.0|-16.99|-2.53|||Mixed Models Analysis|||Month 24||-2.53|-16.99|0.2559
71150625|NCT00658359|141793865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.74|STANDARD_ERROR_OF_MEAN|8.78||0.7548|TWO_SIDED|60.0|-4.65|10.14|||Mixed Models Analysis|||Month 30||10.14|-4.65|0.7548
70956362|NCT02270515|141416318|SUPERIORITY_OR_OTHER|||||||0.002||||||This is the PCS KDQOL Subscale p-value for change in 0-6 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"PCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.002
70956363|NCT02270515|141416318|SUPERIORITY_OR_OTHER|||||||0.23||||||This is the MCS KDQOL Subscale p-value for change in 0-6 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"MCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.23
70956364|NCT02270515|141416318|SUPERIORITY_OR_OTHER|||||||0.18||||||This is the Burden KDQOL Subscale p-value for change in 0-6 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Burden:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.18
70956365|NCT02270515|141416318|SUPERIORITY_OR_OTHER|||||||0.02||||||This is the Symptoms KDQOL Subscale p-value for change in 0-6 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Symptoms:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.02
71150626|NCT00658359|141793865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.43|STANDARD_ERROR_OF_MEAN|9.57||0.7998|TWO_SIDED|60.0|-5.63|10.49|||Mixed Models Analysis|||Match 30||10.49|-5.63|0.7998
71150627|NCT00658359|141793865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.39|STANDARD_ERROR_OF_MEAN|9.08||0.2531|TWO_SIDED|60.0|2.74|18.03|||Mixed Models Analysis|||Month 36||18.03|2.74|0.2531
71150628|NCT00658359|141793865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.14|STANDARD_ERROR_OF_MEAN|11.2||0.365|TWO_SIDED|60.0|0.72|19.57|||Mixed Models Analysis|||Month 36||19.57|0.72|0.3650
71150629|NCT00658359|141793865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.33|STANDARD_ERROR_OF_MEAN|9.34||0.4328|TWO_SIDED|60.0|-0.53|15.19|||Mixed Models Analysis|||Month 42||15.19|-0.53|0.4328
71150630|NCT00658359|141793865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.94|STANDARD_ERROR_OF_MEAN|11.35||0.2547|TWO_SIDED|60.0|-22.5|-3.38|||Mixed Models Analysis|||Month 42||-3.38|-22.50|0.2547
71150631|NCT00658359|141793865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.72|STANDARD_ERROR_OF_MEAN|9.46||0.3572|TWO_SIDED|60.0|0.75|16.69|||Mixed Models Analysis|||Month 48||16.69|0.75|0.3572
71150632|NCT00658359|141793865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.94|STANDARD_ERROR_OF_MEAN|11.64||0.8009|TWO_SIDED|60.0|-6.86|12.74|||Mixed Models Analysis|||Month 48||12.74|-6.86|0.8009
71150633|NCT00658359|141793865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.88|STANDARD_ERROR_OF_MEAN|9.44||0.6814|TWO_SIDED|60.0|-11.82|4.07|||Mixed Models Analysis|||Month 54||4.07|-11.82|0.6814
71150634|NCT00658359|141793865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.88|STANDARD_ERROR_OF_MEAN|11.93||0.2803|TWO_SIDED|60.0|2.84|22.93|||Mixed Models Analysis|||Month 54||22.93|2.84|0.2803
71150635|NCT00658359|141793865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.11|STANDARD_ERROR_OF_MEAN|10.23||0.7613|TWO_SIDED|60.0|-11.72|5.5|||Mixed Models Analysis|||Month 60||5.50|-11.72|0.7613
71150636|NCT00658359|141793865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.25|STANDARD_ERROR_OF_MEAN|12.35||0.8554|TWO_SIDED|60.0|-12.65|8.15|||Mixed Models Analysis|||Month 60||8.15|-12.65|0.8554
71150637|NCT00658359|141793865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|10.7||0.9132|TWO_SIDED|60.0|-10.18|7.84|||Mixed Models Analysis|||Month 66||7.84|-10.18|0.9132
71150638|NCT00658359|141793865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.14|STANDARD_ERROR_OF_MEAN|12.79||0.7465|TWO_SIDED|60.0|-6.63|14.9|||Mixed Models Analysis|||Month 66||14.90|-6.63|0.7465
71150639|NCT00658359|141793865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.79|STANDARD_ERROR_OF_MEAN|11.34||0.8747|TWO_SIDED|60.0|-11.34|7.76|||Mixed Models Analysis|||Month 72||7.76|-11.34|0.8747
71150640|NCT00658359|141793865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.19|STANDARD_ERROR_OF_MEAN|12.96||0.5793|TWO_SIDED|60.0|-18.1|3.72|||Mixed Models Analysis|||Month 72||3.72|-18.10|0.5793
71150641|NCT00658359|141793867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.76|STANDARD_ERROR_OF_MEAN|2.79|<|0.0001|TWO_SIDED|60.0|10.4|15.11|||Mixed Models Analysis|||Month 15||15.11|10.40|<0.0001
71150642|NCT00658359|141793867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.39|STANDARD_ERROR_OF_MEAN|2.88|<|0.0001|TWO_SIDED|60.0|10.96|15.82|||Mixed Models Analysis|||Month 15||15.82|10.96|<0.0001
71150643|NCT00658359|141793867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.48|STANDARD_ERROR_OF_MEAN|3.0||0.0002|TWO_SIDED|60.0|8.95|14.0|||Mixed Models Analysis|||Month 18||14.00|8.95|0.0002
71150644|NCT00658359|141793867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.98|STANDARD_ERROR_OF_MEAN|3.09||0.0002|TWO_SIDED|60.0|9.37|14.59|||Mixed Models Analysis|||Month 18||14.59|9.37|0.0002
71150645|NCT00658359|141793867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.86|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|60.0|10.32|15.39|||Mixed Models Analysis|||Month 24||15.39|10.32|<0.0001
71150646|NCT00658359|141793867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.71|STANDARD_ERROR_OF_MEAN|3.12|<|0.0001|TWO_SIDED|60.0|11.08|16.35|||Mixed Models Analysis|||Month 24||16.35|11.08|<0.0001
71150647|NCT00658359|141793867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.86|STANDARD_ERROR_OF_MEAN|3.35|<|0.0001|TWO_SIDED|60.0|13.03|18.69|||Mixed Models Analysis|||Month 30||18.69|13.03|<0.0001
71150648|NCT00658359|141793867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.61|STANDARD_ERROR_OF_MEAN|3.56||0.0002|TWO_SIDED|60.0|10.61|16.61|||Mixed Models Analysis|||Month 30||16.61|10.61|0.0002
71150649|NCT00658359|141793867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.17|STANDARD_ERROR_OF_MEAN|3.61||0.001|TWO_SIDED|60.0|9.12|15.21|||Mixed Models Analysis|||Month 36||15.21|9.12|0.0010
71150650|NCT00658359|141793867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.56|STANDARD_ERROR_OF_MEAN|3.98||0.0019|TWO_SIDED|60.0|9.2|15.92|||Mixed Models Analysis|||Month 36||15.92|9.20|0.0019
71150651|NCT00658359|141793867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.42|STANDARD_ERROR_OF_MEAN|3.38||0.0004|TWO_SIDED|60.0|9.56|15.27|||Mixed Models Analysis|||Month 42||15.27|9.56|0.0004
71150652|NCT00658359|141793867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.99|STANDARD_ERROR_OF_MEAN|3.76||0.0182|TWO_SIDED|60.0|5.81|12.16|||Mixed Models Analysis|||Month 42||12.16|5.81|0.0182
71150653|NCT00658359|141793867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.4|STANDARD_ERROR_OF_MEAN|3.77||0.0013|TWO_SIDED|60.0|9.22|15.58|||Mixed Models Analysis|||Month 48||15.58|9.22|0.0013
71150654|NCT00658359|141793867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.6|STANDARD_ERROR_OF_MEAN|4.29||0.0782|TWO_SIDED|60.0|3.99|11.22|||Mixed Models Analysis|||Month 48||11.22|3.99|0.0782
71150655|NCT00658359|141793867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.04|STANDARD_ERROR_OF_MEAN|4.02||0.0007|TWO_SIDED|60.0|10.64|17.43|||Mixed Models Analysis|||Month 54||17.43|10.64|0.0007
71150656|NCT00658359|141793867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.23|STANDARD_ERROR_OF_MEAN|4.72||0.0322|TWO_SIDED|60.0|6.24|14.22|||Mixed Models Analysis|||Month 54||14.22|6.24|0.0322
71150657|NCT00658359|141793867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.72|STANDARD_ERROR_OF_MEAN|3.7||0.0399|TWO_SIDED|60.0|4.59|10.86|||Mixed Models Analysis|||Month 60||10.86|4.59|0.0399
71150658|NCT00658359|141793867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.11|STANDARD_ERROR_OF_MEAN|4.28||0.3391|TWO_SIDED|60.0|0.49|7.73|||Mixed Models Analysis|||Month 60||7.73|0.49|0.3391
71150659|NCT00658359|141793867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.75|STANDARD_ERROR_OF_MEAN|4.23||0.0702|TWO_SIDED|60.0|4.17|11.33|||Mixed Models Analysis|||Month 66||11.33|4.17|0.0702
71150660|NCT00658359|141793867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.02|STANDARD_ERROR_OF_MEAN|4.89||0.221|TWO_SIDED|60.0|1.89|10.15|||Mixed Models Analysis|||Month 66||10.15|1.89|0.2210
70876120|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|-0.27|0.74||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.74|-0.27|
70876121|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-0.03|0.91||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.91|-0.03|
70876122|NCT01529346|141236435|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-0.3|0.67||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.67|-0.30|
70876123|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|-0.19|0.14||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.14|-0.19|
70876124|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|0.03|0.37||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.37|0.03|
70876125|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|-0.1|0.24||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.24|-0.10|
70876126|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.16|0.21||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.21|-0.16|
70876127|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.06|0.45||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.45|-0.06|
70876128|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.19|0.7||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.70|0.19|
70876129|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.04|0.54||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.54|0.04|
70876130|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|0.32|0.87||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.87|0.32|
70876131|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.16|0.4||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.40|-0.16|
70876132|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|0.12|0.68||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.68|0.12|
71150661|NCT00658359|141793867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.03|STANDARD_ERROR_OF_MEAN|5.25||0.015|TWO_SIDED|60.0|8.59|17.46|||Mixed Models Analysis|||Month 72||17.46|8.59|0.0150
70876133|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.05|0.5||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.50|-0.05|
71150662|NCT00658359|141793867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.27|STANDARD_ERROR_OF_MEAN|6.13||0.4875|TWO_SIDED|60.0|-0.91|9.45|||Mixed Models Analysis|||Month 72||9.45|-0.91|0.4875
71150663|NCT00658359|141793868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.48|STANDARD_ERROR_OF_MEAN|4.33||0.001|TWO_SIDED|60.0|10.83|18.13|||Mixed Models Analysis|||Month 15||18.13|10.83|0.0010
71150664|NCT00658359|141793868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.93|STANDARD_ERROR_OF_MEAN|4.47||0.001|TWO_SIDED|60.0|11.16|18.7|||Mixed Models Analysis|||Month 15||18.70|11.16|0.0010
70876134|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.71|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|0.4|1.01||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.01|0.40|
70876135|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.19|0.4||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.40|-0.19|
70876136|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.1|0.49||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.49|-0.10|
70956366|NCT02270515|141416318|SUPERIORITY_OR_OTHER|||||||0.004||||||This is the Effects KDQOL Subscale p-value for change in 0-6 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Effects:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.004
70956367|NCT02270515|141416318|SUPERIORITY_OR_OTHER|||||||0.01||||||This is the PCS KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"PCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.01
70956368|NCT02270515|141416318|SUPERIORITY_OR_OTHER|||||||0.21||||||This is the MCS KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"MCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.21
70956369|NCT02270515|141416318|SUPERIORITY_OR_OTHER|||||||0.77||||||This is the Burden KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Burden:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.77
70956370|NCT02270515|141416318|SUPERIORITY_OR_OTHER|||||||0.77||||||This is the Symptoms KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Symptoms:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.77
70956371|NCT02270515|141416318|SUPERIORITY_OR_OTHER|||||||0.14||||||This is the Effects KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Effects:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.14
70956372|NCT02270515|141416318|SUPERIORITY_OR_OTHER|||||||0.45||||||This is the PCS KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"PCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.45
71150665|NCT00658359|141793868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.96|STANDARD_ERROR_OF_MEAN|4.5||0.0023|TWO_SIDED|60.0|10.16|17.76|||Mixed Models Analysis|||Month 18||17.76|10.16|0.0023
71150666|NCT00658359|141793868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.57|STANDARD_ERROR_OF_MEAN|4.64||0.0039|TWO_SIDED|60.0|9.65|17.48|||Mixed Models Analysis|||Month 18||17.48|9.65|0.0039
71150667|NCT00658359|141793868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.02|STANDARD_ERROR_OF_MEAN|4.72||0.0017|TWO_SIDED|60.0|11.04|19.0|||Mixed Models Analysis|||Month 24||19.00|11.04|0.0017
71150668|NCT00658359|141793868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.93|STANDARD_ERROR_OF_MEAN|4.88||0.0026|TWO_SIDED|60.0|10.81|19.04|||Mixed Models Analysis|||Month 24||19.04|10.81|0.0026
71150669|NCT00658359|141793868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.54|STANDARD_ERROR_OF_MEAN|5.06||0.0003|TWO_SIDED|60.0|14.27|22.81|||Mixed Models Analysis|||Month 30||22.81|14.27|0.0003
71150670|NCT00658359|141793868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.45|STANDARD_ERROR_OF_MEAN|5.29||0.0022|TWO_SIDED|60.0|11.99|20.91|||Mixed Models Analysis|||Month 30||20.91|11.99|0.0022
71150671|NCT00658359|141793868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.19|STANDARD_ERROR_OF_MEAN|5.51||0.0065|TWO_SIDED|60.0|10.55|19.84|||Mixed Models Analysis|||Month 36||19.84|10.55|0.0065
70876137|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.16|0.43||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.43|-0.16|
70876138|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.74|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|0.41|1.06||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.06|0.41|
70876139|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|0.01|0.64||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.64|0.01|
70876140|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.01|0.62||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.62|-0.01|
70876141|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|0.08|0.71||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.71|0.08|
70876142|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|1.26|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|0.92|1.61||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.61|0.92|
70876143|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|0.04|0.76||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.76|0.04|
70956373|NCT02270515|141416318|SUPERIORITY_OR_OTHER|||||||0.79||||||This is the MCS KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"MCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.79
70956374|NCT02270515|141416318|SUPERIORITY_OR_OTHER|||||||0.77||||||This is the Burden KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Burden:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.77
70956375|NCT02270515|141416318|SUPERIORITY_OR_OTHER|||||||0.03||||||This is the Symptoms KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Symptoms:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.03
70956376|NCT02270515|141416318|SUPERIORITY_OR_OTHER|||||||0.12||||||This is the Effects KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Effects:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.12
71150672|NCT00658359|141793868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.93|STANDARD_ERROR_OF_MEAN|6.0||0.0137|TWO_SIDED|60.0|9.87|19.99|||Mixed Models Analysis|||Month 36||19.99|9.87|0.0137
71150673|NCT00658359|141793868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.32|STANDARD_ERROR_OF_MEAN|5.12||0.0018|TWO_SIDED|60.0|11.99|20.64|||Mixed Models Analysis|||Month 42||20.64|11.99|0.0018
70876144|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|-0.03|0.69||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.69|-0.03|
70876145|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|0.05|0.77||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.77|0.05|
70876146|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|0.92|1.68||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.68|0.92|
71150674|NCT00658359|141793868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.24|STANDARD_ERROR_OF_MEAN|5.65||0.0316|TWO_SIDED|60.0|7.47|17.01|||Mixed Models Analysis|||Month 42||17.01|7.47|0.0316
70876147|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|0.16|0.95||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.95|0.16|
70876148|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|0.17|0.97||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.97|0.17|
70876149|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|0.24|1.03||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.03|0.24|
70876150|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|1.38|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|0.97|1.78||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.78|0.97|
70876151|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|0.08|0.92||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.92|0.08|
70876152|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.03|0.84||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.84|-0.03|
70876153|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|0.09|0.93||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.93|0.09|
70876154|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|1.17|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|0.75|1.59||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.59|0.75|
70876155|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|-0.27|0.72||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.72|-0.27|
70876156|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|90.0|-0.37|0.65||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.65|-0.37|
70876157|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|-0.23|0.77||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.77|-0.23|
70876158|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.82|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|0.33|1.31||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.31|0.33|
70876159|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.24|0.89||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.89|-0.24|
70876160|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-0.25|0.94||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.94|-0.25|
70876161|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.31|0.8||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.80|-0.31|
70876162|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.64|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|0.08|1.19||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.19|0.08|
70956377|NCT02270515|141416318|SUPERIORITY_OR_OTHER|||||||0.29||||||This is the PCS KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"PCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.29
70956378|NCT02270515|141416318|SUPERIORITY_OR_OTHER|||||||0.01||||||This is the MCS KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"MCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.01
70956379|NCT02270515|141416318|SUPERIORITY_OR_OTHER|||||||0.08||||||This is the Burden KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Burden:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.08
70956380|NCT02270515|141416318|SUPERIORITY_OR_OTHER|||||||0.61||||||This is the Symptoms KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Symptoms:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.61
70956381|NCT02270515|141416318|SUPERIORITY_OR_OTHER|||||||0.02||||||This is the Effects KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Effects:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.02
70956382|NCT00911768|141416319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.181|STANDARD_ERROR_OF_MEAN|0.416|<|0.05||95.0|-0.647|1.008|||t-test, 2 sided|||||1.008|-0.647|<0.05
70956383|NCT00911768|141416320|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority analysis was conducted. We just compared the difference of stimulated salivary rates between both groups at 8 weeks, because there were no definition of the effective margin.|Mean Difference (Final Values)|-0.346|STANDARD_ERROR_OF_MEAN|0.116|<|0.05||95.0|-0.576|-0.115|||t-test, 2 sided|||||-0.115|-0.576|<0.05
70956384|NCT00911768|141416321|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority analysis was conducted. We just compared the difference of unstimulated salivary rates between both groups at 8 weeks, because there were no definition of the effective margin.|Mean Difference (Final Values)|-0.086|STANDARD_ERROR_OF_MEAN|0.035|<|0.05||95.0|-0.155|-0.017|||t-test, 2 sided|||||-0.017|-0.155|<0.05
70956385|NCT00935818|141416336|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.03|TWO_SIDED|95.0|1.05|2.12|||Regression, Logistic|||Logistic regression with covariate included for study site.||2.12|1.05|0.03
70956386|NCT00935818|141416337|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.03|TWO_SIDED|95.0|1.04|2.22|||Regression, Logistic|||Logistic Regression - adjusting for study site||2.22|1.04|0.03
70956387|NCT00935818|141416338|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||< 0.001
70956388|NCT00935818|141416339|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.09|TWO_SIDED|95.0|0.95|1.93|||Regression, Logistic|||Logistic regression adjusted for study site||1.93|0.95|0.09
70956389|NCT00935818|141416340|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.14|TWO_SIDED|95.0|0.91|1.91|||Regression, Logistic|||Logistic Regression adjusting for study site||1.91|0.91|0.14
70956390|NCT00935818|141416341|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.11|TWO_SIDED|95.0|0.93|2.07|||Regression, Logistic|||Logistic Regression - adjusting for study site||2.07|0.93|0.11
70956391|NCT00935818|141416342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.08|TWO_SIDED|95.0|0.96|2.05|||Regression, Logistic|||Logistic Regression - adjusting for site||2.05|0.96|0.08
71150675|NCT00658359|141793868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.33|STANDARD_ERROR_OF_MEAN|5.64||0.0043|TWO_SIDED|60.0|11.57|21.09|||Mixed Models Analysis|||Month 48||21.09|11.57|0.0043
71150676|NCT00658359|141793868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.8|STANDARD_ERROR_OF_MEAN|6.31||0.1226|TWO_SIDED|60.0|4.47|15.12|||Mixed Models Analysis|||Month 48||15.12|4.47|0.1226
71150677|NCT00658359|141793868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.97|STANDARD_ERROR_OF_MEAN|5.7||0.0034|TWO_SIDED|60.0|12.17|21.78|||Mixed Models Analysis|||Month 54||21.78|12.17|0.0034
71150678|NCT00658359|141793868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.79|STANDARD_ERROR_OF_MEAN|6.52||0.0724|TWO_SIDED|60.0|6.29|17.29|||Mixed Models Analysis|||Month 54||17.29|6.29|0.0724
70876163|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.45|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|0.07|0.83||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.83|0.07|
70956392|NCT01370590|141416343|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet was considered equivalent to co-administration of ezetimibe 10 mg and atorvastatin 20 mg, if the two-sided 97.5% expanded confidence intervals of the treatment difference in least squares means for percent change in LDL-C from baseline after 6 weeks of treatment (combination minus co-administration) was contained within -4% and 4% (equivalence margins).|Difference in Least-square Means|-0.2|||||TWO_SIDED|97.5|-1.7|3.3|||ANCOVA|||It was anticipated that 85% of the enrolled participants would be evaluable to achieve 95% power in order to establish equivalence between the Ezetimibe/Atorvastatin Fixed Dose Combination and the co-administration of Ezetimibe and Atorvastatin with respect to percent change from baseline in LDL-C after 6 weeks of treatment using two one-sided tests each at 2.5% α-level, assuming the underlying true treatment difference is ±1.4% and that the standard deviation of the difference is 12.8%.||3.3|-1.7|
70956393|NCT01370590|141416344|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-square means|0.3|||||TWO_SIDED|97.5|-0.8|1.4|||ANCOVA|||||1.4|-0.8|
70956394|NCT01370590|141416345|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares mean|0.8|||||TWO_SIDED|97.5|-0.6|2.2|||ANCOVA|||||2.2|-0.6|
70956395|NCT01370590|141416346|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|0.0|||||TWO_SIDED|97.5|-1.3|1.4|||ANCOVA|||||1.4|-1.3|
70956396|NCT01370590|141416347|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|0.7|||||TWO_SIDED|97.5|-0.6|1.9|||ANCOVA|||||1.9|-0.6|
70956397|NCT01370590|141416348|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|1.6|||||TWO_SIDED|97.5|-3.2|6.3|||Constrained Longitudinal Data Analysis|||Analyses were based on log-transformed data.||6.3|-3.2|
70956398|NCT00604825|141416359|SUPERIORITY||Adjusted Mean Difference|0.75||||0.215|TWO_SIDED|95.0|-0.44|1.93||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. GSK232802 25 mg||1.93|-0.44|0.215
70956399|NCT00604825|141416359|SUPERIORITY||Adjusted Mean Difference|1.21||||0.041|TWO_SIDED|95.0|0.05|2.37||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. GSK232802 75 mg||2.37|0.05|0.041
70956400|NCT00604825|141416359|SUPERIORITY||Adjusted Mean Difference|-2.06|||<|0.001|TWO_SIDED|95.0|-3.2|-0.92||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. Premarin 0.3 mg||-0.92|-3.20|<0.001
70956401|NCT00604825|141416360|SUPERIORITY||Adjusted Mean Difference|0.15||||0.202|TWO_SIDED|95.0|-0.08|0.38||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. GSK232802 25 mg||0.38|-0.08|0.202
70876164|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-0.36|0.44||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.44|-0.36|
70876165|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|-0.07|0.68||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.68|-0.07|
70956402|NCT00604825|141416360|SUPERIORITY||Adjusted Mean Difference|0.31||||0.008|TWO_SIDED|95.0|0.08|0.54||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. GSK232802 75 mg||0.54|0.08|0.008
70956403|NCT00604825|141416360|SUPERIORITY||Adjusted Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.75|-0.3||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. Premarin 0.3 mg||-0.30|-0.75|<0.001
70956404|NCT04617275|141416403|SUPERIORITY||Mean Difference (Final Values)|2.31||||0.5863|TWO_SIDED|90.0|-15.23|19.85||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||19.85|-15.23|0.5863
70956405|NCT04617275|141416403|SUPERIORITY||Mean Difference (Final Values)|-17.41||||0.0494|TWO_SIDED|90.0|-34.75|-0.06||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.06|-34.75|0.0494
70956406|NCT04617275|141416403|SUPERIORITY||Mean Difference (Final Values)|-30.85||||0.0019|TWO_SIDED|90.0|-48.09|-13.61||1-Sided|Mixed Models Analysis|MMRM|Test = PF06882961 Reference = Placebo|||-13.61|-48.09|0.0019
70956407|NCT04617275|141416403|SUPERIORITY||Mean Difference (Final Values)|-33.66||||0.0009|TWO_SIDED|90.0|-51.0|-16.32||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-16.32|-51.00|0.0009
70956408|NCT04617275|141416403|SUPERIORITY||Mean Difference (Final Values)|-19.52||||0.0343|TWO_SIDED|90.0|-37.12|-1.92||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-1.92|-37.12|0.0343
70956409|NCT04617275|141416404|SUPERIORITY||Mean Difference (Final Values)|-3.33||||0.3804|TWO_SIDED|90.0|-21.41|14.76||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||14.76|-21.41|0.3804
70956410|NCT04617275|141416404|SUPERIORITY||Mean Difference (Final Values)|-19.65||||0.0348|TWO_SIDED|90.0|-37.44|-1.87||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-1.87|-37.44|0.0348
70956411|NCT04617275|141416404|SUPERIORITY||Mean Difference (Final Values)|-32.8||||0.0014|TWO_SIDED|90.0|-50.54|-15.05||1-Sided|Mixed Models Analysis|MMRM|Test = PF06882961 Reference = Placebo|||-15.05|-50.54|0.0014
70956412|NCT04617275|141416404|SUPERIORITY||Mean Difference (Final Values)|-35.85||||0.0007|TWO_SIDED|90.0|-53.9|-17.81||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-17.81|-53.90|0.0007
70876166|NCT01529346|141236436|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.32|0.45||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.45|-0.32|
70876167|NCT01529346|141236437|SUPERIORITY_OR_OTHER||LS Mean Difference|2.07|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|90.0|0.43|3.71||||||SPID(6): LS mean estimate of the treatment difference along with 90% confidence interval (CI) were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||3.71|0.43|
70876168|NCT01529346|141236437|SUPERIORITY_OR_OTHER||LS Mean Difference|1.69|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|90.0|0.05|3.33||||||SPID(6): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||3.33|0.05|
70876169|NCT01529346|141236437|SUPERIORITY_OR_OTHER||LS Mean Difference|2.34|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|90.0|0.69|3.99||||||SPID(6): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||3.99|0.69|
70876170|NCT01529346|141236437|SUPERIORITY_OR_OTHER||LS Mean Difference|6.99|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|90.0|5.19|8.79||||||SPID(6): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||8.79|5.19|
70876171|NCT01529346|141236437|SUPERIORITY_OR_OTHER||LS Mean Difference|9.8|STANDARD_ERROR_OF_MEAN|4.74|||TWO_SIDED|90.0|1.97|17.63||||||SPID(24): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||17.63|1.97|
70876172|NCT01529346|141236437|SUPERIORITY_OR_OTHER||LS Mean Difference|3.55|STANDARD_ERROR_OF_MEAN|4.74|||TWO_SIDED|90.0|-4.28|11.37||||||SPID(24): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||11.37|-4.28|
70876173|NCT01529346|141236437|SUPERIORITY_OR_OTHER||LS Mean Difference|10.82|STANDARD_ERROR_OF_MEAN|4.76|||TWO_SIDED|90.0|2.97|18.68||||||SPID(24): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||18.68|2.97|
71150679|NCT00658359|141793868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.03|STANDARD_ERROR_OF_MEAN|5.92||0.1782|TWO_SIDED|60.0|3.02|13.03|||Mixed Models Analysis|||Month 60||13.03|3.02|0.1782
71150680|NCT00658359|141793868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.66|STANDARD_ERROR_OF_MEAN|6.86||0.5947|TWO_SIDED|60.0|-2.14|9.46|||Mixed Models Analysis|||Month 66||9.46|-2.14|0.5947
71150681|NCT00658359|141793868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.99|STANDARD_ERROR_OF_MEAN|5.68||0.081|TWO_SIDED|60.0|5.2|14.79|||Mixed Models Analysis|||Month 66||14.79|5.20|0.0810
71150682|NCT00658359|141793868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.42|STANDARD_ERROR_OF_MEAN|6.38||0.3965|TWO_SIDED|60.0|0.04|10.81|||Mixed Models Analysis|||Month 66||10.81|0.04|0.3965
71150683|NCT00658359|141793868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.16|STANDARD_ERROR_OF_MEAN|6.77||0.0128|TWO_SIDED|60.0|11.44|22.88|||Mixed Models Analysis|||Month 72||22.88|11.44|0.0128
70876174|NCT01529346|141236437|SUPERIORITY_OR_OTHER||LS Mean Difference|22.39|STANDARD_ERROR_OF_MEAN|5.19|||TWO_SIDED|90.0|13.82|30.97||||||SPID(24): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||30.97|13.82|
70956413|NCT04617275|141416404|SUPERIORITY||Mean Difference (Final Values)|-28.49||||0.0052|TWO_SIDED|90.0|-46.6|-10.37||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-10.37|-46.60|0.0052
71150684|NCT00658359|141793868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.71|STANDARD_ERROR_OF_MEAN|7.83||0.5487|TWO_SIDED|60.0|-1.91|11.33|||Mixed Models Analysis|||Month 72||11.33|-1.91|0.5487
71150685|NCT00658359|141793869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.87|STANDARD_ERROR_OF_MEAN|2.86|<|0.0001|TWO_SIDED|60.0|13.46|18.29|||Mixed Models Analysis|||Month 15||18.29|13.46|<0.0001
71150686|NCT00658359|141793869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.97|STANDARD_ERROR_OF_MEAN|2.95|<|0.0001|TWO_SIDED|60.0|11.49|16.46|||Mixed Models Analysis|||Month 15||16.46|11.49|<0.0001
71150687|NCT00658359|141793869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.53|STANDARD_ERROR_OF_MEAN|3.33|<|0.0001|TWO_SIDED|60.0|10.71|16.34|||Mixed Models Analysis|||Month 18||16.34|10.71|<0.0001
71150688|NCT00658359|141793869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.56|STANDARD_ERROR_OF_MEAN|3.43||0.0009|TWO_SIDED|60.0|8.67|14.45|||Mixed Models Analysis|||Month 18||14.45|8.67|0.0009
71150689|NCT00658359|141793869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.63|STANDARD_ERROR_OF_MEAN|3.44|<|0.0001|TWO_SIDED|60.0|12.72|18.53|||Mixed Models Analysis|||Month 24||18.53|12.72|<0.0001
71150690|NCT00658359|141793869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.89|STANDARD_ERROR_OF_MEAN|3.54||0.001|TWO_SIDED|60.0|8.91|14.88|||Mixed Models Analysis|||Month 24||14.88|8.91|0.0010
71150691|NCT00658359|141793869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.29|STANDARD_ERROR_OF_MEAN|3.86|<|0.0001|TWO_SIDED|60.0|16.03|22.55|||Mixed Models Analysis|||Month 30||22.55|16.03|<0.0001
71150692|NCT00658359|141793869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.63|STANDARD_ERROR_OF_MEAN|3.97||0.0082|TWO_SIDED|60.0|7.27|13.98|||Mixed Models Analysis|||Month 30||13.98|7.27|0.0082
71150693|NCT00658359|141793869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.72|STANDARD_ERROR_OF_MEAN|4.31||0.0008|TWO_SIDED|60.0|11.09|18.36|||Mixed Models Analysis|||Month 36||18.36|11.09|0.0008
71150694|NCT00658359|141793869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|STANDARD_ERROR_OF_MEAN|4.43||0.0462|TWO_SIDED|60.0|5.16|12.64|||Mixed Models Analysis|||Month 36||12.64|5.16|0.0462
71150695|NCT00658359|141793869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.7|STANDARD_ERROR_OF_MEAN|4.25||0.0007|TWO_SIDED|60.0|11.11|18.28|||Mixed Models Analysis|||Month 42||18.28|11.11|0.0007
71150696|NCT00658359|141793869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.55|STANDARD_ERROR_OF_MEAN|4.37||0.0519|TWO_SIDED|60.0|4.87|12.24|||Mixed Models Analysis|||Month 42||12.24|4.87|0.0519
71150697|NCT00658359|141793869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.58|STANDARD_ERROR_OF_MEAN|4.65||0.0039|TWO_SIDED|60.0|9.66|17.5|||Mixed Models Analysis|||Month 48||17.50|9.66|0.0039
71150698|NCT00658359|141793869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.12|STANDARD_ERROR_OF_MEAN|4.78||0.058|TWO_SIDED|60.0|5.09|13.15|||Mixed Models Analysis|||Month 48||13.15|5.09|0.0580
71150699|NCT00658359|141793869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.61|STANDARD_ERROR_OF_MEAN|4.74||0.0006|TWO_SIDED|60.0|12.62|20.61|||Mixed Models Analysis|||Month 54||20.61|12.62|0.0006
71150700|NCT00658359|141793869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.15|STANDARD_ERROR_OF_MEAN|4.87||0.0136|TWO_SIDED|60.0|8.04|16.26|||Mixed Models Analysis|||Month 54||16.26|8.04|0.0136
71150701|NCT00658359|141793869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.39|STANDARD_ERROR_OF_MEAN|4.74||0.0053|TWO_SIDED|60.0|9.39|17.39|||Mixed Models Analysis|||Month 60||17.39|9.39|0.0053
70876175|NCT01529346|141236438|SUPERIORITY_OR_OTHER||LS Mean Difference|12.26|STANDARD_ERROR_OF_MEAN|6.66|||TWO_SIDED|90.0|1.26|23.27||||||LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||23.27|1.26|
71150702|NCT00658359|141793869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.77|STANDARD_ERROR_OF_MEAN|4.87||0.0736|TWO_SIDED|60.0|4.66|12.88|||Mixed Models Analysis|||Month 60||12.88|4.66|0.0736
71150703|NCT00658359|141793869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.63|STANDARD_ERROR_OF_MEAN|4.8||0.005|TWO_SIDED|60.0|9.58|17.67|||Mixed Models Analysis|||Month 66||17.67|9.58|0.0050
71150704|NCT00658359|141793869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.77|STANDARD_ERROR_OF_MEAN|4.93||0.0491|TWO_SIDED|60.0|5.61|13.93|||Mixed Models Analysis|||Month 66||13.93|5.61|0.0491
71150705|NCT00658359|141793869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.66|STANDARD_ERROR_OF_MEAN|5.04||0.0041|TWO_SIDED|60.0|10.4|18.91|||Mixed Models Analysis|||Month 72||18.91|10.40|0.0041
71150706|NCT00658359|141793869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.59|STANDARD_ERROR_OF_MEAN|5.19||0.066|TWO_SIDED|60.0|5.22|13.97|||Mixed Models Analysis|||Month 72||13.97|5.22|0.0660
71150707|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|1.73||0.2393|TWO_SIDED|95.0|-5.45|1.36|||Mixed Models Analysis|||Month 24: Physical Functioning||1.36|-5.45|0.2393
71150708|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.57|STANDARD_ERROR_OF_MEAN|1.89||0.0595|TWO_SIDED|95.0|-7.29|0.14|||Mixed Models Analysis|||Month 24: Physical Functioning||0.14|-7.29|0.0595
71150709|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|2.1||0.5182|TWO_SIDED|95.0|-2.77|5.49|||Mixed Models Analysis|||Month 24: Role Physical||5.49|-2.77|0.5182
71150710|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.96|STANDARD_ERROR_OF_MEAN|2.3||0.3938|TWO_SIDED|95.0|-6.49|2.56|||Mixed Models Analysis|||Month 24: Role Physical||2.56|-6.49|0.3938
71150711|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|2.12||0.8932|TWO_SIDED|95.0|-3.89|4.46|||Mixed Models Analysis|||Month 24: Bodily Pain||4.46|-3.89|0.8932
71150712|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|2.33||0.9673|TWO_SIDED|95.0|-4.48|4.67|||Mixed Models Analysis|||Month 24: Bodily Pain||4.67|-4.48|0.9673
71150713|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.74|STANDARD_ERROR_OF_MEAN|1.78||0.329|TWO_SIDED|95.0|-1.76|5.23|||Mixed Models Analysis|||Month 24: General Health||5.23|-1.76|0.3290
71150714|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.09|STANDARD_ERROR_OF_MEAN|1.95||0.578|TWO_SIDED|95.0|-2.75|4.92|||Mixed Models Analysis|||Month 24: General Health||4.92|-2.75|0.5780
71150715|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|1.87||0.9799|TWO_SIDED|95.0|-3.72|3.62|||Mixed Models Analysis|||Month 24: Vitality||3.62|-3.72|0.9799
70956414|NCT04617275|141416405|SUPERIORITY||Mean Difference (Final Values)|-25.58||||0.025|TWO_SIDED|90.0|-46.97|-4.18||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-4.18|-46.97|0.0250
71150716|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.76|STANDARD_ERROR_OF_MEAN|2.07||0.396|TWO_SIDED|95.0|-2.31|5.83|||Mixed Models Analysis|||Month 24: Vitality||5.83|-2.31|0.3960
71150717|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|1.98||0.94|TWO_SIDED|95.0|-4.05|3.75|||Mixed Models Analysis|||Month 24: Social Functioning||3.75|-4.05|0.9400
71150718|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|2.2||0.8583|TWO_SIDED|95.0|-3.94|4.72|||Mixed Models Analysis|||Month 24: Social Functioning||4.72|-3.94|0.8583
70876176|NCT01529346|141236438|SUPERIORITY_OR_OTHER||LS Mean Difference|4.18|STANDARD_ERROR_OF_MEAN|6.66|||TWO_SIDED|90.0|-6.82|15.18||||||LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||15.18|-6.82|
70876177|NCT01529346|141236438|SUPERIORITY_OR_OTHER||LS Mean Difference|12.57|STANDARD_ERROR_OF_MEAN|6.69|||TWO_SIDED|90.0|1.52|23.61||||||||23.61|1.52|
71150719|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.82|STANDARD_ERROR_OF_MEAN|2.31||0.0997|TWO_SIDED|95.0|-0.73|8.37|||Mixed Models Analysis|||Month 24: Role Emotional||8.37|-0.73|0.0997
71150720|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|2.54||0.852|TWO_SIDED|95.0|-5.47|4.52|||Mixed Models Analysis|||Month 24: Role Emotional||4.52|-5.47|0.8520
71150721|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69|STANDARD_ERROR_OF_MEAN|2.01||0.4023|TWO_SIDED|95.0|-5.64|2.27|||Mixed Models Analysis|||Month 24: Mental Health||2.27|-5.64|0.4023
71150722|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.56|STANDARD_ERROR_OF_MEAN|2.22||0.1092|TWO_SIDED|95.0|-0.8|7.92|||Mixed Models Analysis|||Month 24: Mental Health||7.92|-0.80|0.1092
71150723|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.16||0.1754|TWO_SIDED|95.0|-0.1|0.52|||Mixed Models Analysis|||Month 24: TR Scale Score||0.52|-0.10|0.1754
71150724|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.17||0.1802|TWO_SIDED|95.0|-0.11|0.57|||Mixed Models Analysis|||Month 24: TR Scale Score||0.57|-0.11|0.1802
71150725|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|1.68||0.9966|TWO_SIDED|95.0|-3.31|3.29|||Mixed Models Analysis|||Month 24: Physical Component Summary||3.29|-3.31|0.9966
71150726|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.42|STANDARD_ERROR_OF_MEAN|1.84||0.188|TWO_SIDED|95.0|-6.04|1.19|||Mixed Models Analysis|||Month 24: Physical Component Summary||1.19|-6.04|0.1880
71150727|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|1.92||0.6154|TWO_SIDED|95.0|-2.81|4.73|||Mixed Models Analysis|||Month 24: Mental Component Summary||4.73|-2.81|0.6154
71150728|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.26|STANDARD_ERROR_OF_MEAN|2.12||0.1248|TWO_SIDED|95.0|-0.91|7.43|||Mixed Models Analysis|||Month 24: Mental Component Summary||7.43|-0.91|0.1248
71150729|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|2.03||0.4174|TWO_SIDED|95.0|-5.63|2.34|||Mixed Models Analysis|||Month 36: Physical Functioning||2.34|-5.63|0.4174
71150730|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.44|STANDARD_ERROR_OF_MEAN|2.6||0.3486|TWO_SIDED|95.0|-7.54|2.66|||Mixed Models Analysis|||Month 36: Physical Functioning||2.66|-7.54|0.3486
71150731|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|2.47||0.8335|TWO_SIDED|95.0|-4.33|5.37|||Mixed Models Analysis|||Month 36: Role Physical||5.37|-4.33|0.8335
71150732|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|3.18||0.5291|TWO_SIDED|95.0|-8.24|4.24|||Mixed Models Analysis|||Month 36: Role Physical||4.24|-8.24|0.5291
71150733|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.09|STANDARD_ERROR_OF_MEAN|2.5||0.4033|TWO_SIDED|95.0|-2.82|7.0|||Mixed Models Analysis|||Month 36: Bodily Pain||7.00|-2.82|0.4033
71150734|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|3.24||0.9078|TWO_SIDED|95.0|-6.74|5.99|||Mixed Models Analysis|||Month 36: Bodily Pain||5.99|-6.74|0.9078
71150735|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.77|STANDARD_ERROR_OF_MEAN|2.08||0.3947|TWO_SIDED|95.0|-2.31|5.86|||Mixed Models Analysis|||Month 36: General Health||5.86|-2.31|0.3947
71150736|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|2.66||0.7165|TWO_SIDED|95.0|-4.26|6.2|||Mixed Models Analysis|||Month 36: General Health||6.20|-4.26|0.7165
71150737|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44|STANDARD_ERROR_OF_MEAN|2.19||0.5112|TWO_SIDED|95.0|-2.87|5.75|||Mixed Models Analysis|||Month 36: Vitality||5.75|-2.87|0.5112
71150738|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.43|STANDARD_ERROR_OF_MEAN|2.86||0.1218|TWO_SIDED|95.0|-1.18|10.04|||Mixed Models Analysis|||Month 36: Vitality||10.04|-1.18|0.1218
71150739|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.47|STANDARD_ERROR_OF_MEAN|2.33||0.2895|TWO_SIDED|95.0|-2.11|7.05|||Mixed Models Analysis|||Month 36: Social Functioning||7.05|-2.11|0.2895
71150740|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|3.03||0.8349|TWO_SIDED|95.0|-6.58|5.32|||Mixed Models Analysis|||Month 36: Social Functioning||5.32|-6.58|0.8349
71150741|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.62|STANDARD_ERROR_OF_MEAN|2.72||0.0393|TWO_SIDED|95.0|0.28|10.97|||Mixed Models Analysis|||Month 36: Role Emotional||10.97|0.28|0.0393
71150742|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.23|STANDARD_ERROR_OF_MEAN|3.52||0.7266|TWO_SIDED|95.0|-5.69|8.16|||Mixed Models Analysis|||Month 36: Role Emotional||8.16|-5.69|0.7266
71150743|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63|STANDARD_ERROR_OF_MEAN|2.36||0.4916|TWO_SIDED|95.0|-3.02|6.27|||Mixed Models Analysis|||Month 36: Mental Health||6.27|-3.02|0.4916
71150744|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|3.05||0.9008|TWO_SIDED|95.0|-5.62|6.38|||Mixed Models Analysis|||Month 36: Mental Health||6.38|-5.62|0.9008
71150745|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.18||0.2965|TWO_SIDED|95.0|-0.17|0.55|||Mixed Models Analysis|||Month 36: TR Scale Score||0.55|-0.17|0.2965
71150746|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.24||0.1147|TWO_SIDED|95.0|-0.09|0.84|||Mixed Models Analysis|||Month 36: TR Scale Score||0.84|-0.09|0.1147
71150747|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|1.97||0.7786|TWO_SIDED|95.0|-4.42|3.31|||Mixed Models Analysis|||Month 36: Physical Component Summary||3.31|-4.42|0.7786
71150748|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.48|STANDARD_ERROR_OF_MEAN|2.53||0.5582|TWO_SIDED|95.0|-6.45|3.49|||Mixed Models Analysis|||Month 36: Physical Component Summary||3.49|-6.45|0.5582
71150749|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.05|STANDARD_ERROR_OF_MEAN|2.25||0.0727|TWO_SIDED|95.0|-0.37|8.47|||Mixed Models Analysis|||Month 36: Mental Component Summary||8.47|-0.37|0.0727
70876178|NCT01529346|141236438|SUPERIORITY_OR_OTHER||LS Mean Difference|32.56|STANDARD_ERROR_OF_MEAN|7.3|||TWO_SIDED|90.0|20.51|44.61||||||||44.61|20.51|
70956415|NCT04617275|141416405|SUPERIORITY||Mean Difference (Final Values)|-32.95||||0.0053|TWO_SIDED|90.0|-53.95|-11.95||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-11.95|-53.95|0.0053
71150750|NCT00658359|141793870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.86|STANDARD_ERROR_OF_MEAN|2.91||0.3264|TWO_SIDED|95.0|-2.86|8.59|||Mixed Models Analysis|||Month 36: Mental Component Summary||8.59|-2.86|0.3264
71150751|NCT00658359|141793871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.11||0.3093|TWO_SIDED|95.0|-0.1|0.33|||Mixed Models Analysis|||Month 24 Limited Physical Capacity||0.33|-0.10|0.3093
71150752|NCT00658359|141793871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.12||0.3223|TWO_SIDED|95.0|-0.12|0.36|||Mixed Models Analysis|||Month 24 Limited Physical Capacity||0.36|-0.12|0.3223
71150753|NCT00658359|141793871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.11||0.4858|TWO_SIDED|95.0|-0.14|0.3|||Mixed Models Analysis|||Month 24 Limited Cognitive Capacity||0.30|-0.14|0.4858
71150754|NCT00658359|141793871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.13||0.3679|TWO_SIDED|95.0|-0.13|0.36|||Mixed Models Analysis|||Month 24 Limited Cognitive Capacity||0.36|-0.13|0.3679
71150755|NCT00658359|141793871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.11||0.6416|TWO_SIDED|95.0|-0.27|0.17|||Mixed Models Analysis|||Month 24 Cardiac and Renal Dysfunction||0.17|-0.27|0.6416
71150756|NCT00658359|141793871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.4241|TWO_SIDED|95.0|-0.34|0.14|||Mixed Models Analysis|||Month 24 Cardiac and Renal Dysfunction||0.14|-0.34|0.4241
70956416|NCT04617275|141416405|SUPERIORITY||Mean Difference (Final Values)|-40.07||||0.0012|TWO_SIDED|90.0|-61.41|-18.73|||Mixed Models Analysis|MMRM|Test = PF06882961 Reference = Placebo|||-18.73|-61.41|0.0012
71150757|NCT00658359|141793871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.12||0.2133|TWO_SIDED|95.0|-0.09|0.39|||Mixed Models Analysis|||Month 24 Side Effects of Corticosteroids||0.39|-0.09|0.2133
70956417|NCT04617275|141416405|SUPERIORITY||Mean Difference (Final Values)|-45.47||||0.0003|TWO_SIDED|90.0|-66.85|-24.1||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-24.10|-66.85|0.0003
70876179|NCT01529346|141236439|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|90.0|0.6|1.5||||||Hazard Ratio (HR) estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.5|0.6|
70956418|NCT04617275|141416405|SUPERIORITY||Mean Difference (Final Values)|-33.63||||0.0055|TWO_SIDED|90.0|-55.19|-12.08||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-12.08|-55.19|0.0055
70956419|NCT04617275|141416406|SUPERIORITY||Mean Difference (Final Values)|-27.79||||0.0127|TWO_SIDED|90.0|-48.12|-7.47||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-7.47|-48.12|0.0127
70956420|NCT04617275|141416406|SUPERIORITY||Mean Difference (Final Values)|-25.67||||0.0171|TWO_SIDED|90.0|-45.51|-5.83||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-5.83|-45.51|0.0171
70956421|NCT04617275|141416406|SUPERIORITY||Mean Difference (Final Values)|-46.94||||0.0001|TWO_SIDED|90.0|-67.16|-26.72||1-Sided|Mixed Models Analysis|MMRM|Test = PF06882961 Reference = Placebo|||-26.72|-67.16|0.0001
71150758|NCT00658359|141793871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.13||0.1918|TWO_SIDED|95.0|-0.09|0.44|||Mixed Models Analysis|||Month 24 Side Effects of Corticosteroids||0.44|-0.09|0.1918
71150759|NCT00658359|141793871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.55|-0.14|||Mixed Models Analysis|||Month 24 Increased Growth of Gum and Hair||-0.14|-0.55|0.0010
71150760|NCT00658359|141793871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.12||0.002|TWO_SIDED|95.0|-0.59|-0.13|||Mixed Models Analysis|||Month 24 Increased Growth of Gum and Hair||-0.13|-0.59|0.0020
71150761|NCT00658359|141793871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.12||0.2012|TWO_SIDED|95.0|-0.08|0.4|||Mixed Models Analysis|||Month 24 Transplantation-Associated Psychological Distress||0.40|-0.08|0.2012
71150762|NCT00658359|141793871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.14||0.8986|TWO_SIDED|95.0|-0.25|0.29|||Mixed Models Analysis|||Month 24 Transplantation-Associated Psychological Distress||0.29|-0.25|0.8986
71150763|NCT00658359|141793871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.08||0.6724|TWO_SIDED|95.0|-0.13|0.2|||Mixed Models Analysis|||Month 24 Global Score||0.20|-0.13|0.6724
71150764|NCT00658359|141793871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.09||0.9297|TWO_SIDED|95.0|-0.18|0.19|||Mixed Models Analysis|||Month 24 Global Score||0.19|-0.18|0.9297
71150765|NCT00658359|141793871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.13||0.8682|TWO_SIDED|95.0|-0.28|0.23|||Mixed Models Analysis|||Month 36 Limited Physical Capacity||0.23|-0.28|0.8682
71150766|NCT00658359|141793871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.18||0.3392|TWO_SIDED|95.0|-0.18|0.53|||Mixed Models Analysis|||Month 36 Limited Physical Capacity||0.53|-0.18|0.3392
71150767|NCT00658359|141793871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.13||0.6545|TWO_SIDED|95.0|-0.2|0.32|||Mixed Models Analysis|||Month 36 Limited Cognitive Capacity||0.32|-0.20|0.6545
71150768|NCT00658359|141793871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.19||0.3253|TWO_SIDED|95.0|-0.18|0.55|||Mixed Models Analysis|||Month 36 Limited Cognitive Capacity||0.55|-0.18|0.3253
71150769|NCT00658359|141793871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.13||0.9698|TWO_SIDED|95.0|-0.26|0.25|||Mixed Models Analysis|||Month 36 Cardiac and Renal Dysfunction||0.25|-0.26|0.9698
71150770|NCT00658359|141793871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.18||0.3065|TWO_SIDED|95.0|-0.17|0.54|||Mixed Models Analysis|||Month 36 Cardiac and Renal Dysfunction||0.54|-0.17|0.3065
71150771|NCT00658359|141793871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.14||0.7147|TWO_SIDED|95.0|-0.33|0.23|||Mixed Models Analysis|||Month 36 Side Effects of Corticosteroids||0.23|-0.33|0.7147
71150772|NCT00658359|141793871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.2||0.4852|TWO_SIDED|95.0|-0.25|0.53|||Mixed Models Analysis|||Month 36 Side Effects of Corticosteroids||0.53|-0.25|0.4852
71150773|NCT00658359|141793871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.13||0.0888|TWO_SIDED|95.0|-0.46|0.03|||Mixed Models Analysis|||Month 36 Increased Growth of Gum and Hair||0.03|-0.46|0.0888
70956422|NCT04617275|141416406|SUPERIORITY||Mean Difference (Final Values)|-33.79||||0.0037|TWO_SIDED|90.0|-54.32|-13.27||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-13.27|-54.32|0.0037
71150774|NCT00658359|141793871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.17||0.0719|TWO_SIDED|95.0|-0.65|0.03|||Mixed Models Analysis|||Month 36 Increased Growth of Gum and Hair||0.03|-0.65|0.0719
71150775|NCT00658359|141793871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.7531|TWO_SIDED|95.0|-0.24|0.33|||Mixed Models Analysis|||Month 36 Transplantation-Associated Psychological Distress||0.33|-0.24|0.7531
70956423|NCT04617275|141416406|SUPERIORITY||Mean Difference (Final Values)|-42.13||||0.0005|TWO_SIDED|90.0|-62.85|-21.4||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-21.40|-62.85|0.0005
71150776|NCT00658359|141793871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.2||0.6412|TWO_SIDED|95.0|-0.49|0.3|||Mixed Models Analysis|||Month 36 Transplantation-Associated Psychological Distress||0.30|-0.49|0.6412
71150777|NCT00658359|141793871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.1||0.9186|TWO_SIDED|95.0|-0.2|0.18|||Mixed Models Analysis|||Month 36 Global Score||0.18|-0.20|0.9186
71150778|NCT00658359|141793871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.14||0.6629|TWO_SIDED|95.0|-0.21|0.33|||Mixed Models Analysis|||Month 36 Global Score||0.33|-0.21|0.6629
71150779|NCT00658359|141793872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.85|STANDARD_ERROR_OF_MEAN|1.72||0.2826|TWO_SIDED|95.0|-5.22|1.53|||Mixed Models Analysis|||Month 24 Pain Intensity Total Converted Score||1.53|-5.22|0.2826
71150780|NCT00658359|141793872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.22|STANDARD_ERROR_OF_MEAN|1.97||0.5371|TWO_SIDED|95.0|-2.65|5.09|||Mixed Models Analysis|||Month 24 Pain Intensity Total Converted Score||5.09|-2.65|0.5371
71150781|NCT00658359|141793872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.62||0.7503|TWO_SIDED|95.0|-1.41|1.02|||Mixed Models Analysis|||Month 24 Non-Pain Symptoms Converted Score||1.02|-1.41|0.7503
71150782|NCT00658359|141793872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|0.72||0.261|TWO_SIDED|95.0|-0.6|2.21|||Mixed Models Analysis|||Month 24 Non-Pain Symptoms Converted Score||2.21|-0.60|0.2610
70876180|NCT01529346|141236439|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3|||||TWO_SIDED|90.0|0.9|1.9||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.9|0.9|
70956424|NCT04617275|141416407|SUPERIORITY||Mean Difference (Final Values)|-12.85||||0.1678|TWO_SIDED|90.0|-34.9|9.21||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||9.21|-34.90|0.1678
71150783|NCT00658359|141793872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89|STANDARD_ERROR_OF_MEAN|0.98||0.3656|TWO_SIDED|95.0|-1.04|2.82|||Mixed Models Analysis|||Month 24 Satisfaction Converted Score||2.82|-1.04|0.3656
71150784|NCT00658359|141793872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|STANDARD_ERROR_OF_MEAN|1.15||0.4405|TWO_SIDED|95.0|-3.16|1.37|||Mixed Models Analysis|||Month 24 Satisfaction Converted Score||1.37|-3.16|0.4405
71150785|NCT00658359|141793872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|1.96||0.4135|TWO_SIDED|95.0|-5.45|2.25|||Mixed Models Analysis|||Month 36 Pain Intensity Total Converted Score||2.25|-5.45|0.4135
71150786|NCT00658359|141793872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|2.75||0.7272|TWO_SIDED|95.0|-4.45|6.37|||Mixed Models Analysis|||Month 36 Pain Intensity Total Converted Score||6.37|-4.45|0.7272
71150787|NCT00658359|141793872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.71||0.8111|TWO_SIDED|95.0|-1.56|1.22|||Mixed Models Analysis|||Month 36 Non-Pain symptoms Converted Score||1.22|-1.56|0.8111
71150788|NCT00658359|141793872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.14|STANDARD_ERROR_OF_MEAN|1.02||0.2636|TWO_SIDED|95.0|-0.86|3.13|||Mixed Models Analysis|||Month 36 Non-Pain Symptoms Converted Score||3.13|-0.86|0.2636
71150789|NCT00658359|141793872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|1.13||0.689|TWO_SIDED|95.0|-1.77|2.67|||Mixed Models Analysis|||Month 36 Satisfaction Converted Score||2.67|-1.77|0.6890
71150790|NCT00658359|141793872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13|STANDARD_ERROR_OF_MEAN|1.62||0.4853|TWO_SIDED|95.0|-4.31|2.05|||Mixed Models Analysis|||Month 36 Satisfaction Converted Score||2.05|-4.31|0.4853
71150791|NCT02754440|141793875|OTHER|A procedure is a success if the subject's platelet product has a residual WBC count of \< 5.0 × 10\^6 for the single platelet product group. The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 450 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|||0.968|
71150792|NCT02754440|141793875|OTHER|A procedure is a success if the subject's platelet product has a residual WBC count of \< 8.0 × 10\^6 for the double platelet product group, or \< 5.0 × 10\^6 for each transfusable unit . The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 450 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|||0.968|
71150793|NCT02754440|141793875|OTHER|A procedure is a success if the subject's platelet product has a residual WBC count of \< 12.0 × 10\^6 for the triple platelet product group, or \< 5.0 × 10\^6 for each transfusable unit . The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 450 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|||0.968|
70876181|NCT01529346|141236439|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|90.0|0.7|1.6||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.6|0.7|
70876182|NCT01529346|141236439|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6|||||TWO_SIDED|90.0|1.0|2.4||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||2.4|1.0|
70876183|NCT01529346|141236440|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.0|||||TWO_SIDED|90.0|1.1|3.8||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||3.8|1.1|
70876184|NCT01529346|141236440|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.6|||||TWO_SIDED|90.0|1.4|4.9||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||4.9|1.4|
70876185|NCT01529346|141236440|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.2|||||TWO_SIDED|90.0|1.1|4.1||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||4.1|1.1|
70876186|NCT01529346|141236440|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.3|||||TWO_SIDED|90.0|2.8|9.9||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||9.9|2.8|
70876187|NCT01529346|141236441|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|90.0|0.4|1.0||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.0|0.4|
70876188|NCT01529346|141236441|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|90.0|0.5|1.2||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.2|0.5|
70876189|NCT01529346|141236441|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||||TWO_SIDED|90.0|0.3|0.8||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||0.8|0.3|
70876190|NCT01529346|141236441|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||||TWO_SIDED|90.0|0.2|0.6||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||0.6|0.2|
70876191|NCT03454581|141236457|SUPERIORITY||Mean Difference (Final Values)|0.05|||<|0.001|TWO_SIDED|95.0|||||Regression, Linear|||||||<0.001
70876192|NCT03454581|141236458|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Generalized Estimating Equation|||||||0.05
70876193|NCT03454581|141236459|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Generalized Estimating Equation|||||||0.05
70876194|NCT03454581|141236460|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Generalized Estimating Equation|||||||<0.05
70876195|NCT03454581|141236461|OTHER||||||<|0.01|||||||Generalized Estimating Equation|||||||<0.01
70876196|NCT03454581|141236462|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Generalized Estimating Equation|||||||0.05
70876197|NCT03454581|141236463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Generalized Estimating Equation|||||||0.05
70876198|NCT03454581|141236464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Generalized Estimating Equation|||||||0.05
70876199|NCT02902965|141236465|OTHER||median PFS|8.5|||||TWO_SIDED|95.0|6.2|10.8|||||Kaplan-Meier estimates for median PFS and its associated 95% confidence intervals using log-log transformed Greenwood variance estimate were calculated.|||10.8|6.2|
70876200|NCT02902965|141236466|OTHER||ORR in %|56.8|||||TWO_SIDED|95.0|44.7|68.2|||||Overall response = confirmed sCR + CR + VGPR + PR with corresponding 95% Exact binomial Cl|||68.2|44.7|
70876201|NCT02902965|141236467|OTHER||PFS rate|6.6|||||TWO_SIDED|95.0|1.6|16.9|||||Kaplan-Meier method used for PFS rate and its associated 95% confidence intervals using log-log transformed Greenwood variance estimate were calculated.|||16.9|1.6|
70876202|NCT02902965|141236470|OTHER||median TTP|10.6|||||TWO_SIDED|95.0|7.8|12.0|||||KM estimates for median TTP with associated 95% CI|||12|7.8|
70956425|NCT04617275|141416407|SUPERIORITY||Mean Difference (Final Values)|-14.82||||0.1223|TWO_SIDED|90.0|-35.85|6.21||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||6.21|-35.85|0.1223
70956426|NCT04617275|141416407|SUPERIORITY||Mean Difference (Final Values)|-33.97||||0.0054|TWO_SIDED|90.0|-55.66|-12.28||1-Sided|Mixed Models Analysis|MMRM|Test = PF06882961 Reference = Placebo|||-12.28|-55.66|0.0054
71150794|NCT02754440|141793876|OTHER|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 3.0 × 10\^11 for the single platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|0.957|STANDARD_ERROR_OF_MEAN|0.021|||ONE_SIDED|95.0|0.904|||||||Up to 450 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|||0.904|
71150795|NCT02754440|141793876|OTHER|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 6.2 × 10\^11 for the double platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 450 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|||0.968|
71150796|NCT02754440|141793876|OTHER|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 9.3 × 10\^11 for the triple platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 450 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|||0.968|
71150797|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|2.27|||||TWO_SIDED|95.0|-3.96|8.49||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||8.49|-3.96|
71150798|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|0.198|||||TWO_SIDED|95.0|-3.19|3.59||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||3.59|-3.19|
71150799|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|1.55|||||TWO_SIDED|95.0|-2.25|5.35||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.35|-2.25|
71150800|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|20.0|||||TWO_SIDED|95.0|13.7|26.2||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||26.2|13.7|
71150801|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|6.19|||||TWO_SIDED|95.0|2.8|9.58||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||9.58|2.80|
71150802|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|11.7|||||TWO_SIDED|95.0|7.87|15.5||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||15.5|7.87|
71150803|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|-13.9|||||TWO_SIDED|95.0|-18.9|-8.8||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-8.80|-18.9|
71150804|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|-4.62|||||TWO_SIDED|95.0|-7.67|-1.56||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-1.56|-7.67|
71150805|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|-8.43|||||TWO_SIDED|95.0|-11.5|-5.33||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-5.33|-11.5|
71150806|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|7.8|||||TWO_SIDED|95.0|2.72|12.9||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||12.9|2.72|
70956427|NCT04617275|141416407|SUPERIORITY||Mean Difference (Final Values)|1.31||||0.5398|TWO_SIDED|90.0|-20.38|22.99||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||22.99|-20.38|0.5398
71150807|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|4.38|||||TWO_SIDED|95.0|1.3|7.46||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||7.46|1.30|
71150808|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|5.06|||||TWO_SIDED|95.0|1.93|8.18||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||8.18|1.93|
71150809|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|0.905|||||TWO_SIDED|95.0|-5.49|7.3||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 3 where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||7.30|-5.49|
71150810|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|-2.71|||||TWO_SIDED|95.0|-6.96|1.54||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 3 where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||1.54|-6.96|
71150811|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|1.66|||||TWO_SIDED|95.0|-2.85|6.16||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||6.16|-2.85|
71150812|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|17.5|||||TWO_SIDED|95.0|11.2|23.8||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 3 where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||23.8|11.2|
71150813|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|6.51|||||TWO_SIDED|95.0|2.32|10.7||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||10.7|2.32|
71150814|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|14.2|||||TWO_SIDED|95.0|9.75|18.7||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||18.7|9.75|
71150815|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|-9.98|||||TWO_SIDED|95.0|-14.6|-5.34||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-5.34|-14.6|
71150816|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|-3.46|||||TWO_SIDED|95.0|-7.22|0.297||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||0.297|-7.22|
71150817|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|-8.16|||||TWO_SIDED|95.0|-11.6|-4.71||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-4.71|-11.6|
71150818|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|12.1|||||TWO_SIDED|95.0|7.39|16.8||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||16.8|7.39|
71150819|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|6.7|||||TWO_SIDED|95.0|2.91|10.5||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||10.5|2.91|
71150820|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|10.3|||||TWO_SIDED|95.0|6.88|13.8||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||13.8|6.88|
71150821|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|-1.06|||||TWO_SIDED|95.0|-7.41|5.3||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.30|-7.41|
71150822|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|2.2|||||TWO_SIDED|95.0|-2.15|6.56||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||6.56|-2.15|
71150823|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|1.12|||||TWO_SIDED|95.0|-3.23|5.47||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.47|-3.23|
71150824|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|19.4|||||TWO_SIDED|95.0|13.2|25.6||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 5 where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||25.6|13.2|
71150825|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|9.04|||||TWO_SIDED|95.0|4.78|13.3||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 5 where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||13.3|4.78|
71150826|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|14.7|||||TWO_SIDED|95.0|10.4|18.9||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||18.9|10.4|
71150827|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|-10.6|||||TWO_SIDED|95.0|-15.6|-5.52||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-5.52|-15.6|
71150828|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|-4.25|||||TWO_SIDED|95.0|-9.26|0.764||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||0.764|-9.26|
71150829|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|-8.76|||||TWO_SIDED|95.0|-12.6|-4.87||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-4.87|-12.6|
70876203|NCT02564042|141236508|OTHER||Proportion difference|54.7|||||TWO_SIDED|95.0|25.9|76.6|||||Difference between GSK2894512 1% BID and Vehicle BID has been presented|||76.6|25.9|
70956428|NCT04617275|141416407|SUPERIORITY||Mean Difference (Final Values)|-14.42||||0.1409|TWO_SIDED|90.0|-36.56|7.72||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||7.72|-36.56|0.1409
70956429|NCT04617275|141416408|SUPERIORITY||Mean Difference (Final Values)|-28.65||||0.0236|TWO_SIDED|90.0|-52.31|-4.99||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-4.99|-52.31|0.0236
70956430|NCT04617275|141416408|SUPERIORITY||Mean Difference (Final Values)|-27.32||||0.0226|TWO_SIDED|90.0|-49.67|-4.97||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-4.97|-49.67|0.0226
70956431|NCT04617275|141416408|SUPERIORITY||Mean Difference (Final Values)|-40.85||||0.0022|TWO_SIDED|90.0|-64.11|-17.59||1-Sided|Mixed Models Analysis|MMRM|Test = PF06882961 Reference = Placebo|||-17.59|-64.11|0.0022
70956432|NCT04617275|141416408|SUPERIORITY||Mean Difference (Final Values)|-10.25||||0.2335|TWO_SIDED|90.0|-33.59|13.08||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||13.08|-33.59|0.2335
70956433|NCT04617275|141416408|SUPERIORITY||Mean Difference (Final Values)|-24.38||||0.0494|TWO_SIDED|90.0|-48.69|-0.08||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.08|-48.69|0.0494
70956434|NCT04617275|141416409|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.2485|TWO_SIDED|90.0|-0.31|0.13||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.13|-0.31|0.2485
70956435|NCT04617275|141416409|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.0252|TWO_SIDED|90.0|-0.48|-0.04||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.04|-0.48|0.0252
70956436|NCT04617275|141416409|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.0053|TWO_SIDED|90.0|-0.56|-0.12||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.12|-0.56|0.0053
70956437|NCT04617275|141416409|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.009|TWO_SIDED|90.0|-0.54|-0.1||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.10|-0.54|0.0090
70956438|NCT04617275|141416409|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.1066|TWO_SIDED|90.0|-0.39|0.05||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.05|-0.39|0.1066
70956439|NCT04617275|141416410|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.274|TWO_SIDED|90.0|-0.4|0.19||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.19|-0.40|0.2740
70956440|NCT04617275|141416410|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.0196|TWO_SIDED|90.0|-0.66|-0.08||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.08|-0.66|0.0196
70956441|NCT04617275|141416410|SUPERIORITY||Mean Difference (Final Values)|-0.59||||0.0006|TWO_SIDED|90.0|-0.88|-0.3|||Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.30|-0.88|0.0006
70956442|NCT04617275|141416410|SUPERIORITY||Mean Difference (Final Values)|-0.53||||0.0019|TWO_SIDED|90.0|-0.82|-0.23||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.23|-0.82|0.0019
70956443|NCT04617275|141416410|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.0243|TWO_SIDED|90.0|-0.66|-0.06||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.06|-0.66|0.0243
70956444|NCT04617275|141416411|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.1587|TWO_SIDED|90.0|-0.62|0.15||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.15|-0.62|0.1587
71150830|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|12.3|||||TWO_SIDED|95.0|7.17|17.4||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||17.4|7.17|
70956445|NCT04617275|141416411|SUPERIORITY||Mean Difference (Final Values)|-0.66||||0.0027|TWO_SIDED|90.0|-1.04|-0.27||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.27|-1.04|0.0027
70956446|NCT04617275|141416411|SUPERIORITY||Mean Difference (Final Values)|-0.85||||0.0002|TWO_SIDED|90.0|-1.24|-0.47||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.47|-1.24|0.0002
70956447|NCT04617275|141416411|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.0016|TWO_SIDED|90.0|-1.1|-0.32||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.32|-1.10|0.0016
70956448|NCT04617275|141416411|SUPERIORITY||Mean Difference (Final Values)|-0.67||||0.0027|TWO_SIDED|90.0|-1.07|-0.28||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.28|-1.07|0.0027
70956449|NCT04617275|141416412|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.0472|TWO_SIDED|90.0|-0.86|-0.01||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.01|-0.86|0.0472
70956450|NCT04617275|141416412|SUPERIORITY||Mean Difference (Final Values)|-0.87||||0.0004|TWO_SIDED|90.0|-1.29|-0.45||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.45|-1.29|0.0004
70956451|NCT04617275|141416412|SUPERIORITY||Mean Difference (Final Values)|-1.1|||<|0.0001|TWO_SIDED|90.0|-1.53|-0.68||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.68|-1.53|<0.0001
70956452|NCT04617275|141416412|SUPERIORITY||Mean Difference (Final Values)|-0.93||||0.0003|TWO_SIDED|90.0|-1.36|-0.5||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.50|-1.36|0.0003
70956453|NCT04617275|141416412|SUPERIORITY||Mean Difference (Final Values)|-0.91||||0.0004|TWO_SIDED|90.0|-1.34|-0.47||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.47|-1.34|0.0004
70956454|NCT04617275|141416413|SUPERIORITY||Mean Difference (Final Values)|-0.69||||0.0116|TWO_SIDED|90.0|-1.18|-0.19||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.19|-1.18|0.0116
70956455|NCT04617275|141416413|SUPERIORITY||Mean Difference (Final Values)|-0.94||||0.0008|TWO_SIDED|90.0|-1.43|-0.46|||Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.46|-1.43|0.0008
70956456|NCT04617275|141416413|SUPERIORITY||Mean Difference (Final Values)|-1.16|||<|0.0001|TWO_SIDED|90.0|-1.66|-0.67||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.67|-1.66|<0.0001
70956457|NCT04617275|141416413|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.0017|TWO_SIDED|90.0|-1.4|-0.4||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.40|-1.40|0.0017
70956458|NCT04617275|141416413|SUPERIORITY||Mean Difference (Final Values)|-1.05||||0.0004|TWO_SIDED|90.0|-1.55|-0.55||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.55|-1.55|0.0004
70956459|NCT04617275|141416414|SUPERIORITY||Mean Difference (Final Values)|-0.76||||0.0132|TWO_SIDED|90.0|-1.32|-0.2||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.20|-1.32|0.0132
70956460|NCT04617275|141416414|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.0014|TWO_SIDED|90.0|-1.55|-0.46||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.46|-1.55|0.0014
70956461|NCT04617275|141416414|SUPERIORITY||Mean Difference (Final Values)|-1.25||||0.0002|TWO_SIDED|90.0|-1.8|-0.69||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.69|-1.80|0.0002
70956462|NCT04617275|141416414|SUPERIORITY||Mean Difference (Final Values)|-0.73||||0.0174|TWO_SIDED|90.0|-1.29|-0.16|||Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.16|-1.29|0.0174
70956463|NCT04617275|141416414|SUPERIORITY||Mean Difference (Final Values)|-1.25||||0.0002|TWO_SIDED|90.0|-1.82|-0.69||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.69|-1.82|0.0002
70956464|NCT04617275|141416415|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.2843|TWO_SIDED|90.0|-1.02|0.5||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.50|-1.02|0.2843
70956465|NCT04617275|141416415|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.431|TWO_SIDED|90.0|-0.84|0.68||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.68|-0.84|0.4310
70956466|NCT04617275|141416415|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.2402|TWO_SIDED|90.0|-1.07|0.43||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.43|-1.07|0.2402
71150831|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|5.95|||||TWO_SIDED|95.0|0.917|11.0||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||11.0|0.917|
71150832|NCT01263197|141793896|SUPERIORITY_OR_OTHER||LS mean difference|9.9|||||TWO_SIDED|95.0|5.98|13.8||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||13.8|5.98|
71150833|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|1.62|||||TWO_SIDED|95.0|-1.81|5.06||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.06|-1.81|
70956467|NCT04617275|141416415|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.1397|TWO_SIDED|90.0|-1.24|0.26||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.26|-1.24|0.1397
70956468|NCT04617275|141416415|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.4393|TWO_SIDED|90.0|-0.85|0.71||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.71|-0.85|0.4393
70956469|NCT04617275|141416416|SUPERIORITY||Mean Difference (Final Values)|-0.77||||0.1491|TWO_SIDED|90.0|-2.0|0.45||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.45|-2.00|0.1491
70956470|NCT04617275|141416416|SUPERIORITY||Median Difference (Final Values)|0.12||||0.5664|TWO_SIDED|90.0|-1.09|1.34||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||1.34|-1.09|0.5664
70956471|NCT04617275|141416416|SUPERIORITY||Median Difference (Final Values)|-1.12||||0.0632|TWO_SIDED|90.0|-2.33|0.09||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.09|-2.33|0.0632
70956472|NCT04617275|141416416|SUPERIORITY||Median Difference (Final Values)|-1.01||||0.0847|TWO_SIDED|90.0|-2.23|0.2||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.20|-2.23|0.0847
70956473|NCT04617275|141416416|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.5264|TWO_SIDED|90.0|-1.2|1.3||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||1.30|-1.20|0.5264
70956474|NCT04617275|141416417|SUPERIORITY||Mean Difference (Final Values)|-1.48||||0.0395|TWO_SIDED|90.0|-2.86|-0.1||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.10|-2.86|0.0395
70956475|NCT04617275|141416417|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.3726|TWO_SIDED|90.0|-1.63|1.1||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||1.10|-1.63|0.3726
70956476|NCT04617275|141416417|SUPERIORITY||Mean Difference (Final Values)|-2.36||||0.0028|TWO_SIDED|90.0|-3.74|-0.98||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.98|-3.74|0.0028
70956477|NCT04617275|141416417|SUPERIORITY||Mean Difference (Final Values)|-1.85||||0.0139|TWO_SIDED|90.0|-3.23|-0.47||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.47|-3.23|0.0139
70956478|NCT04617275|141416417|SUPERIORITY||Mean Difference (Final Values)|-0.78||||0.1815|TWO_SIDED|90.0|-2.19|0.64||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.64|-2.19|0.1815
70956479|NCT04617275|141416418|SUPERIORITY||Mean Difference (Final Values)|-2.16||||0.0112|TWO_SIDED|90.0|-3.71|-0.61||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.61|-3.71|0.0112
70956480|NCT04617275|141416418|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.2161|TWO_SIDED|90.0|-2.24|0.8||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.80|-2.24|0.2161
70956481|NCT04617275|141416418|SUPERIORITY||Mean Difference (Final Values)|-3.47||||0.0002|TWO_SIDED|90.0|-5.02|-1.92||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-1.92|-5.02|0.0002
70956482|NCT04617275|141416418|SUPERIORITY||Mean Difference (Final Values)|-2.05||||0.0147|TWO_SIDED|90.0|-3.59|-0.51||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.51|-3.59|0.0147
70956483|NCT04617275|141416418|SUPERIORITY||Mean Difference (Final Values)|-2.97||||0.0013|TWO_SIDED|90.0|-4.56|-1.37||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-1.37|-4.56|0.0013
70956484|NCT04617275|141416419|SUPERIORITY||Mean Difference (Final Values)|-2.46||||0.0111|TWO_SIDED|90.0|-4.22|-0.7||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.70|-4.22|0.0111
70956485|NCT04617275|141416419|SUPERIORITY||Mean Difference (Final Values)|-1.03||||0.16|TWO_SIDED|90.0|-2.75|0.68||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.68|-2.75|0.1600
70956486|NCT04617275|141416419|SUPERIORITY||Mean Difference (Final Values)|-4.27|||<|0.0001|TWO_SIDED|90.0|-6.03|-2.52||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-2.52|-6.03|<0.0001
70956487|NCT04617275|141416419|SUPERIORITY||Mean Difference (Final Values)|-2.68||||0.0061|TWO_SIDED|90.0|-4.42|-0.94||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.94|-4.42|0.0061
71150834|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|2.73|||||TWO_SIDED|95.0|-1.38|6.85||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||6.85|-1.38|
71150835|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|2.67|||||TWO_SIDED|95.0|-0.209|5.56||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.56|-0.209|
71150836|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|0.541|||||TWO_SIDED|95.0|-2.94|4.02||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||4.02|-2.94|
71150837|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|5.26|||||TWO_SIDED|95.0|1.09|9.43||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||9.43|1.09|
71150838|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|2.6|||||TWO_SIDED|95.0|-0.322|5.52||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||5.52|-0.322|
71150839|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|-6.46|||||TWO_SIDED|95.0|-11.5|-1.41||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-1.41|-11.5|
71150840|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|0.171|||||TWO_SIDED|95.0|-5.21|5.56||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||5.56|-5.21|
71150841|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|-3.09|||||TWO_SIDED|95.0|-6.73|0.557||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||0.557|-6.73|
71150842|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|1.46|||||TWO_SIDED|95.0|-3.61|6.53||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||6.53|-3.61|
71150843|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|11.4|||||TWO_SIDED|95.0|5.99|16.8||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||16.8|5.99|
71150844|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|7.15|||||TWO_SIDED|95.0|3.49|10.8||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||10.8|3.49|
71150845|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|0.0309|||||TWO_SIDED|95.0|-5.28|5.34||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.34|-5.28|
70876204|NCT02564042|141236508|OTHER||Proportion difference|51.0|||||TWO_SIDED|95.0|22.2|73.2|||||Difference between GSK2894512 1% QD and Vehicle QD has been presented|||73.2|22.2|
70956488|NCT04617275|141416419|SUPERIORITY||Mean Difference (Final Values)|-3.71||||0.0005|TWO_SIDED|90.0|-5.52|-1.89||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-1.89|-5.52|0.0005
70876205|NCT02564042|141236508|OTHER||Proportion difference|35.6|||||TWO_SIDED|95.0|6.3|60.5|||||Difference between GSK2894512 0.5% BID and Vehicle BID has been presented|||60.5|6.3|
70876206|NCT02564042|141236508|OTHER||Proportion difference|30.7|||||TWO_SIDED|95.0|1.6|55.9|||||Difference between GSK2894512 0.5% QD and Vehicle QD has been presented|||55.9|1.6|
70876207|NCT02564042|141236509|OTHER||Proportion difference|2.9|||||TWO_SIDED|95.0|-21.0|26.6|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 1 has been presented|||26.6|-21.0|
70956489|NCT04617275|141416420|SUPERIORITY||Mean Difference (Final Values)|-3.21||||0.0047|TWO_SIDED|90.0|-5.22|-1.2||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-1.20|-5.22|0.0047
70956490|NCT04617275|141416420|SUPERIORITY||Mean Difference (Final Values)|-1.51||||0.1003|TWO_SIDED|90.0|-3.45|0.44||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.44|-3.45|0.1003
71150846|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|-1.17|||||TWO_SIDED|95.0|-5.93|3.59||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||3.59|-5.93|
71150847|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|-0.333|||||TWO_SIDED|95.0|-4.35|3.68||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||3.68|-4.35|
71150848|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|-2.11|||||TWO_SIDED|95.0|-7.42|3.2||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||3.20|-7.42|
71150849|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|4.36|||||TWO_SIDED|95.0|-0.404|9.12||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||9.12|-0.404|
71150850|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|-0.119|||||TWO_SIDED|95.0|-4.14|3.9||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||3.90|-4.14|
71150851|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|-4.16|||||TWO_SIDED|95.0|-9.69|1.37||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||1.37|-9.69|
70956491|NCT04617275|141416420|SUPERIORITY||Mean Difference (Final Values)|-4.95|||<|0.0001|TWO_SIDED|90.0|-6.96|-2.95||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-2.95|-6.96|<0.0001
70956492|NCT04617275|141416420|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.0197|TWO_SIDED|90.0|-4.49|-0.51||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.51|-4.49|0.0197
70956493|NCT04617275|141416420|SUPERIORITY||Mean Difference (Final Values)|-4.94|||<|0.0001|TWO_SIDED|90.0|-7.03|-2.85||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-2.85|-7.03|<0.0001
70956494|NCT04617275|141416421|SUPERIORITY||Mean Difference (Final Values)|-0.96||||0.0836|TWO_SIDED|90.0|-2.12|0.19||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.19|-2.12|0.0836
70956495|NCT04617275|141416422|SUPERIORITY||Mean Difference (Final Values)|-1.59||||0.0386|TWO_SIDED|90.0|-3.07|-0.12||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.12|-3.07|0.0386
70956496|NCT04617275|141416423|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.1566|TWO_SIDED|90.0|-3.99|1.0||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||1.00|-3.99|0.1566
71150852|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|-4.76|||||TWO_SIDED|95.0|-10.2|0.718||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||0.718|-10.2|
71150853|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|-4.2|||||TWO_SIDED|95.0|-8.71|0.32||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||0.320|-8.71|
70956497|NCT04617275|141416424|SUPERIORITY||Mean Difference (Final Values)|-2.62||||0.0916|TWO_SIDED|90.0|-5.91|0.67||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.67|-5.91|0.0916
70956498|NCT04617275|141416425|SUPERIORITY||Mean Difference (Final Values)|-3.07||||0.059|TWO_SIDED|90.0|-6.31|0.17||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.17|-6.31|0.0590
70956499|NCT04617275|141416426|SUPERIORITY||Mean Difference (Final Values)|-3.74||||0.0826|TWO_SIDED|90.0|-8.23|0.75||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.75|-8.23|0.0826
71150854|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|3.2|||||TWO_SIDED|95.0|-2.34|8.74||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||8.74|-2.34|
71150855|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|3.95|||||TWO_SIDED|95.0|-1.54|9.43||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||9.43|-1.54|
71150856|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|4.84|||||TWO_SIDED|95.0|0.319|9.37||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||9.37|0.319|
71150857|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|2.34|||||TWO_SIDED|95.0|-3.44|8.12||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||8.12|-3.44|
70956500|NCT05593445|141416466|SUPERIORITY||Odds Ratio (OR)|0.83||||0.737|TWO_SIDED|95.0|0.29|2.41|||Chi-squared|||||2.41|0.29|0.737
70956501|NCT05593445|141416466|SUPERIORITY||response rate difference|-4.3|STANDARD_ERROR_OF_MEAN|12.73|||TWO_SIDED|95.0|-29.2|20.7|||||The 95% confidence interval for the response rate difference was constructed from approximately normal distribution.|||20.7|-29.2|
70956502|NCT05593445|141416467|SUPERIORITY||least squares mean difference|-2.76|STANDARD_ERROR_OF_MEAN|1.14||0.0188|TWO_SIDED|95.0|-5.05|-0.47|||Mixed Model Repeated Measures (MMRM)|||||-0.47|-5.05|0.0188
70956503|NCT05593445|141416468|SUPERIORITY||least squares mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.72||0.4674|TWO_SIDED|95.0|-1.96|0.91|||MMRM|||||0.91|-1.96|0.4674
70956504|NCT05593445|141416469|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.9072|TWO_SIDED|95.0|0.503|1.869|||Log Rank||Cox regression model was conducted to compare the difference in hazard rate.|||1.869|0.503|0.9072
70956505|NCT05559476|141416478|NON_INFERIORITY|The non-inferiority is demonstrated if the Upper Limit (UL) of the 2-sided 95% Confidence Interval (CI) of the GMT ratio (Control group divided by Co-Ad group) for RSVPreF3 OA vaccine is less than or equal (\<=)1.5.|GMT Ratio|1.18|||||TWO_SIDED|95.0|1.03|1.35|||||The comparison is done using the adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when co-administered with the FLU vaccine compared to the RSVPreF3 OA vaccine administered alone, in terms of RSV-A neutralizing antibody titers, at 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group).||1.35|1.03|
70956506|NCT05559476|141416479|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|0.99|||||TWO_SIDED|95.0|0.85|1.16|||||The comparison was done using the adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu A/Darwin/6/2021 H3N2 influenza strain, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.16|0.85|
71150858|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|1.89|||||TWO_SIDED|95.0|-3.22|7.0||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||7.00|-3.22|
71150859|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|1.83|||||TWO_SIDED|95.0|-1.85|5.52||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.52|-1.85|
71150860|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|0.327|||||TWO_SIDED|95.0|-5.45|6.1||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||6.10|-5.45|
71150861|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|3.18|||||TWO_SIDED|95.0|-1.93|8.29||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||8.29|-1.93|
71150862|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|2.12|||||TWO_SIDED|95.0|-1.56|5.81||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||5.81|-1.56|
71150863|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|-1.6|||||TWO_SIDED|95.0|-6.79|3.59||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||3.59|-6.79|
71150864|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|-0.163|||||TWO_SIDED|95.0|-5.0|4.68||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||4.68|-5.00|
71150865|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|-0.829|||||TWO_SIDED|95.0|-5.2|3.54||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||3.54|-5.20|
70876208|NCT02564042|141236509|OTHER||Proportion difference|6.3||||||95.0|-20.5|32.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 2 has been presented|||32.4|-20.5|
70876209|NCT02564042|141236509|OTHER||Proportion difference|15.2|||||TWO_SIDED|95.0|-9.6|39.1|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 2 has been presented|||39.1|-9.6|
70876210|NCT02564042|141236509|OTHER||Proportion difference|3.3|||||TWO_SIDED|95.0|-23.6|29.9|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 2 has been presented|||29.9|-23.6|
70876211|NCT02564042|141236509|OTHER||Proportion difference|3.1|||||TWO_SIDED|95.0|-22.2|28.1|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 2 has been presented|||28.1|-22.2|
70876212|NCT02564042|141236509|OTHER||Proportion difference|27.6|||||TWO_SIDED|95.0|-0.5|52.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 4 has been presented|||52.4|-0.5|
70876213|NCT02564042|141236509|OTHER||Proportion difference|25.8|||||TWO_SIDED|95.0|-0.4|49.3|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 4 has been presented|||49.3|-0.4|
70876214|NCT02564042|141236509|OTHER||Proportion difference|9.2|||||TWO_SIDED|95.0|-18.4|35.7|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 4 has been presented|||35.7|-18.4|
70876215|NCT02564042|141236509|OTHER||Proportion difference|6.3|||||TWO_SIDED|95.0|-19.7|31.7|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 4 has been presented|||31.7|-19.7|
71150866|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|1.95|||||TWO_SIDED|95.0|-3.27|7.17||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||7.17|-3.27|
71150867|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|3.71|||||TWO_SIDED|95.0|-1.17|8.59||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||8.59|-1.17|
70876216|NCT02564042|141236509|OTHER||Proportion difference|45.0|||||TWO_SIDED|95.0|16.6|68.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 8 has been presented|||68.4|16.6|
70876217|NCT02564042|141236509|OTHER||Proportion difference|37.0|||||TWO_SIDED|95.0|8.7|61.3|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 8 has been presented|||61.3|8.7|
70876218|NCT02564042|141236509|OTHER||Proportion difference|32.0|||||TWO_SIDED|95.0|3.5|57.2|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 8 has been presented|||57.2|3.5|
70876219|NCT02564042|141236509|OTHER||Proportion difference|34.4|||||TWO_SIDED|95.0|6.3|58.7|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 8 has been presented|||58.7|6.3|
70876220|NCT02564042|141236509|OTHER||Proportion difference|49.4|||||TWO_SIDED|95.0|20.1|72.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 12 has been presented|||72.4|20.1|
70876221|NCT02564042|141236509|OTHER||Proportion difference|51.0|||||TWO_SIDED|95.0|22.2|73.2|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 12 has been presented|||73.2|22.2|
70876222|NCT02564042|141236509|OTHER||Proportion difference|30.4|||||TWO_SIDED|95.0|1.0|56.1|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 12 has been presented|||56.1|1.0|
70876223|NCT02564042|141236509|OTHER||Proportion difference|41.4|||||TWO_SIDED|95.0|12.7|65.0|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 12 has been presented|||65.0|12.7|
71150868|NCT01263197|141793897|SUPERIORITY_OR_OTHER||LS mean difference|4.28|||||TWO_SIDED|95.0|-0.103|8.67||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||8.67|-0.103|
71150869|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|-1.23|||||TWO_SIDED|95.0|-3.9|1.44||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||1.44|-3.90|
71150870|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|1.05|||||TWO_SIDED|95.0|-1.91|4.02||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||4.02|-1.91|
71150871|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|-0.199|||||TWO_SIDED|95.0|-2.58|2.18||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||2.18|-2.58|
71150872|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|1.37|||||TWO_SIDED|95.0|-1.34|4.07||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||4.07|-1.34|
71150873|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|3.68|||||TWO_SIDED|95.0|0.674|6.69||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||6.69|0.674|
71150874|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|2.4|||||TWO_SIDED|95.0|-0.0178|4.81||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||4.81|-0.0178|
70956507|NCT05559476|141416479|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|0.93|||||TWO_SIDED|95.0|0.8|1.09|||||The comparison was done using the adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu A/Victoria/2570/2019 H1N1 influenza strain, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.09|0.80|
70956508|NCT05559476|141416479|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.88|1.03|||||The comparison was done using the adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu B/Austria/1359417/2021 influenza strain, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.03|0.88|
70956509|NCT05559476|141416479|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|0.93|||||TWO_SIDED|95.0|0.84|1.02|||||The comparison was done using the adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu B/Phuket/3073/2013 Yamagata influenza strain, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.02|0.84|
70956510|NCT05559476|141416480|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the GMT ratio (Control group divided by Co-Ad group) for RSVPreF3 OA vaccine is \<=1.5.|GMT Ratio|1.01|||||TWO_SIDED|95.0|0.89|1.15|||||The comparison was done using the adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when co-administered with the FLU vaccine compared to the RSVPreF3 OA vaccine administered alone, in terms of RSV-B neutralizing antibody titers, at 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group).||1.15|0.89|
70956511|NCT05559476|141416481|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|-1.71|||||TWO_SIDED|95.0|-8.15|4.74||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu A/Darwin/6/2021 H3N2 strain at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||4.74|-8.15|
70956512|NCT05559476|141416481|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|-4.11|||||TWO_SIDED|95.0|-10.67|2.48||||||To evaluate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu A/Victoria/2570/2019 H1N1 strain at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||2.48|-10.67|
70956513|NCT05559476|141416481|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|-8.56|||||TWO_SIDED|95.0|-14.75|-2.29||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu B/Austria/1359417/2021 Victoria at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||-2.29|-14.75|
70956514|NCT05559476|141416481|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|-5.89|||||TWO_SIDED|95.0|-12.28|0.56||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu B/Phuket/3073/2013 Yamagata strain at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||0.56|-12.28|
70956515|NCT00266227|141416498|SUPERIORITY_OR_OTHER|||||||0.0195|||||||Cochran-Mantel-Haenszel|||||||0.0195
70956516|NCT00266227|141416500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||||95.0|-0.7|-0.1|||ANOVA|Adjusted mean for Arm A (Rituxan) is -1.9 and adjusted mean for Arm B (Placebo) is -1.5.||Assessed using an analysis of variance (ANOVA) model, with retreatment group, baseline DAS28-ESR score, baseline RF status, and ≥20% improvement in both SJC and TJC at Week 24 from baseline (yes/no) as explanatory terms in the model.||-0.1|-0.7|
70956517|NCT00037830|141416560|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||The null hypothesis for Phase I was that at week 24, there is no difference between UPDRS motor scores in placebo vs. GM1-treated subjects.||||<0.0001
70956518|NCT00037830|141416561|SUPERIORITY_OR_OTHER|||||||0.0368|||||||t-test, 2 sided|||The null hypothesis for Phase II is that long-term use of GM1 does not affect the progression of PD symptoms and that there is no benefit to early start of GM1 use.||||0.0368
70956519|NCT00037830|141416562|SUPERIORITY_OR_OTHER|||||||0.1903|||||||estimate of slope of change over time|random intercept model and a variance components covariance structure||||||0.1903
70956520|NCT00037830|141416562|SUPERIORITY_OR_OTHER|||||||0.0063||95.0|||||estimate slope of change over time|random intercept model and a variance components covariance structure||||||0.0063
70956521|NCT00037830|141416563|SUPERIORITY_OR_OTHER|||||||0.0502|||||||estimate of slope of change over time|random intercept model and a variance components covariance structure||||||0.0502
71150875|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|-4.22|||||TWO_SIDED|95.0|-7.83|-0.619||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-0.619|-7.83|
71150876|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|0.335|||||TWO_SIDED|95.0|-4.45|5.12||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||5.12|-4.45|
71150877|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|-1.92|||||TWO_SIDED|95.0|-4.81|0.969||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||0.969|-4.81|
71150878|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|2.47|||||TWO_SIDED|95.0|-1.15|6.1||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||6.10|-1.15|
71150879|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|9.12|||||TWO_SIDED|95.0|4.3|13.9||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||13.9|4.30|
71150880|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|6.03|||||TWO_SIDED|95.0|3.12|8.94||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||8.94|3.12|
71150881|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|-0.913|||||TWO_SIDED|95.0|-4.65|2.82||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||2.82|-4.65|
71150882|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|-0.444|||||TWO_SIDED|95.0|-4.33|3.44||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||3.44|-4.33|
71150883|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|0.378|||||TWO_SIDED|95.0|-2.2|2.95||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||2.95|-2.20|
71150884|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|0.878|||||TWO_SIDED|95.0|-2.86|4.62||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||4.62|-2.86|
71150885|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|2.92|||||TWO_SIDED|95.0|-0.966|6.8||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||6.80|-0.966|
71150886|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|2.94|||||TWO_SIDED|95.0|0.366|5.52||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||5.52|0.366|
71150887|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|-2.88|||||TWO_SIDED|95.0|-6.84|1.07||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||1.07|-6.84|
71150888|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|-0.975|||||TWO_SIDED|95.0|-5.39|3.44||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||3.44|-5.39|
71150889|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|-1.82|||||TWO_SIDED|95.0|-5.3|1.66||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||1.66|-5.30|
70956522|NCT00037830|141416563|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||estimate slope of change over time|random intercept model and a variance components covariance structure||||||0.0003
70956523|NCT00037830|141416564|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71150890|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|5.6|||||TWO_SIDED|95.0|1.63|9.56||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||9.56|1.63|
71150891|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|7.82|||||TWO_SIDED|95.0|3.39|12.3||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||12.3|3.39|
71150892|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|6.6|||||TWO_SIDED|95.0|3.11|10.1||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||10.1|3.11|
71150893|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|0.847|||||TWO_SIDED|95.0|-3.23|4.92||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||4.92|-3.23|
71150894|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|-3.48|||||TWO_SIDED|95.0|-8.17|1.21||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||1.21|-8.17|
70956524|NCT00037830|141416565|SUPERIORITY_OR_OTHER|||||||0.131|||||||t-test, 2 sided|||||||0.1310
70876224|NCT02564042|141236509|OTHER||Proportion difference|49.4|||||TWO_SIDED|95.0|20.1|72.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 14 has been presented|||72.4|20.1|
70956525|NCT00037830|141416566|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Analysis was paired sample t-test on change from baseline.||||<0.05
70956526|NCT00037830|141416567|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
70956527|NCT00037830|141416568|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
70956528|NCT00037830|141416569|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
70956529|NCT01160289|141416595|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||The p-value was 1-sided and adjusted for multiple comparisons. The level of significance was 1-sided of 0.04.|ANCOVA|Treatment group (tx grp), baseline IIEF EF domain score, baseline testosterone level, tx grp\*baseline IIEF, tx grp\*testosterone level interactions.||Only the treatment effects of 1 mg LY2452473 and 5 mg tadalafil versus 5 mg tadalafil and the treatment effects of 5 mg LY2452473 and 5 mg tadalafil versus 5 mg tadalafil were analyzed.||||0.5
70956530|NCT01160289|141416595|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||The p-value was 1-sided and adjusted for multiple comparisons. The level of significance was 1-sided of 0.04.|ANCOVA|The model included tx grp, baseline IIEF EF domain score, baseline testosterone level, tx grp\*baseline IIEF, tx grp\*testosterone level interactions.||Only the treatment effects of the treatment effects of 5 mg LY2452473 and 5 mg tadalafil versus 5 mg tadalafil and 1 mg LY2452473 and 5 mg tadalafil versus 5 mg tadalafil were analyzed.||||0.498
70956531|NCT01160289|141416596|SUPERIORITY_OR_OTHER||LS mean of treatment difference|1.178|STANDARD_ERROR_OF_MEAN|3.312||0.722||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.722
70956532|NCT01160289|141416596|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-1.552|STANDARD_ERROR_OF_MEAN|3.253||0.634||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.634
70956533|NCT01160289|141416596|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-4.674|STANDARD_ERROR_OF_MEAN|3.218||0.147||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.147
71150895|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|-0.372|||||TWO_SIDED|95.0|-2.88|2.14||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||2.14|-2.88|
70956534|NCT01160289|141416596|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-7.404|STANDARD_ERROR_OF_MEAN|3.157||0.02||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.020
70956535|NCT01160289|141416596|SUPERIORITY_OR_OTHER||LS mean of treatment difference|1.33|STANDARD_ERROR_OF_MEAN|4.658||0.775||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.775
70956536|NCT01160289|141416596|SUPERIORITY_OR_OTHER||LS mean of treatment difference|1.844|STANDARD_ERROR_OF_MEAN|4.573||0.687||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.687
70956537|NCT01160289|141416596|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-7.092|STANDARD_ERROR_OF_MEAN|4.535||0.119||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.119
70956538|NCT01160289|141416596|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-6.578|STANDARD_ERROR_OF_MEAN|4.45||0.14||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.140
70956539|NCT01160289|141416596|SUPERIORITY_OR_OTHER||LS mean of treatment difference|6.703|STANDARD_ERROR_OF_MEAN|5.302||0.207||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.207
70956540|NCT01160289|141416596|SUPERIORITY_OR_OTHER||LS mean of treatment difference|9.159|STANDARD_ERROR_OF_MEAN|5.206||0.079||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.079
70956541|NCT01160289|141416596|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-5.349|STANDARD_ERROR_OF_MEAN|5.165||0.301||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.301
70956542|NCT01160289|141416596|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-2.893|STANDARD_ERROR_OF_MEAN|5.067||0.568||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.568
71150896|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|1.9|||||TWO_SIDED|95.0|-2.17|5.98||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||5.98|-2.17|
70876225|NCT02564042|141236509|OTHER||Proportion difference|60.1|||||TWO_SIDED|95.0|33.2|80.1|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 14 has been presented|||80.1|33.2|
71150897|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|1.07|||||TWO_SIDED|95.0|-3.62|5.76||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||5.76|-3.62|
71150898|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|3.03|||||TWO_SIDED|95.0|0.522|5.55||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||5.55|0.522|
71150899|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|0.737|||||TWO_SIDED|95.0|-3.9|5.38||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||5.38|-3.90|
71150900|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|-1.95|||||TWO_SIDED|95.0|-6.36|2.47||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||2.47|-6.36|
71150901|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|-1.17|||||TWO_SIDED|95.0|-4.79|2.45||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||2.45|-4.79|
71150902|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|7.25|||||TWO_SIDED|95.0|2.59|11.9||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||11.9|2.59|
71150903|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|5.58|||||TWO_SIDED|95.0|1.13|10.0||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||10.0|1.13|
71150904|NCT01263197|141793898|SUPERIORITY_OR_OTHER||LS mean difference|5.53|||||TWO_SIDED|95.0|1.89|9.16||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||9.16|1.89|
71150905|NCT01134055|141793900|SUPERIORITY_OR_OTHER|||||||0.1974||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Injection Rate at 28 Weeks is presented||||0.1974
71150906|NCT01134055|141793900|SUPERIORITY_OR_OTHER|||||||0.8263||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Injection Rate at 28 Weeks is presented||||0.8263
71150907|NCT01134055|141793900|SUPERIORITY_OR_OTHER|||||||0.8263||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Injection Rate at 28 Weeks is presented||||0.8263
71150908|NCT01134055|141793900|SUPERIORITY_OR_OTHER|||||||0.8263||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Injection Rate at 28 Weeks is presented||||0.8263
71150909|NCT01134055|141793900|SUPERIORITY_OR_OTHER|||||||0.7418||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Injection Rate at 28 Weeks is presented||||0.7418
71150910|NCT01134055|141793900|SUPERIORITY_OR_OTHER|||||||0.2429||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Overall Injection Rate at 52 weeks is presented||||0.2429
71150911|NCT01134055|141793900|SUPERIORITY_OR_OTHER|||||||0.97||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Overall Injection Rate at 52 weeks is presented||||0.9700
71150912|NCT01134055|141793900|SUPERIORITY_OR_OTHER|||||||0.97||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Overall Injection Rate at 52 weeks is presented||||0.9700
71150913|NCT01134055|141793900|SUPERIORITY_OR_OTHER|||||||0.97||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Overall Injection Rate at 52 weeks is presented||||0.9700
71150914|NCT01134055|141793900|SUPERIORITY_OR_OTHER|||||||0.7673||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Overall Injection Rate at 52 weeks is presented||||0.7673
71150915|NCT00847210|141793923|SUPERIORITY_OR_OTHER|||||||0.095||95.0||||There was no statistical significant difference (p-value \>0.05) in Tmax between the 30 mg and 60 mg dose group. Both age group and site did not have statistically significant effects on Tmax.|ANOVA|||This study was not powered for any hypothesis testing. For Tmax, an analysis of variance (ANOVA) model was fitted that included fixed effect of age group, regimen and interaction of age group and regimen. If the interaction term was not statistically significant, it was not included in the final model. The site effect was also tested in the model, and was not included in the final model if it was not statistically significant (P\>0.05). Pairwise comparisons between regimens were conducted.||||0.095
71150916|NCT00847210|141793924|SUPERIORITY_OR_OTHER||ratio of the central values for Cmax|1.21||||0.289|TWO_SIDED|90.0|0.897|1.63|||ANOVA||Ninety percent confidence intervals for assessing the dose proportionality of dexlansoprazole pharmacokinetics between regimens were computed based on the frame work of ANOVA.|This study was not powered for any hypothesis testing. For natural logarithm of dose-normalized Cmax, an ANOVA model was fitted that included fixed effect of age group, regimen and interaction of age group and regimen. If the interaction term was not statistically significant, it was not included in the final model. Site effect was tested in the model, and was not included in the final model if not statistically significant (P\>0.05). Pairwise comparisons between regimens were conducted.||1.630|0.897|0.289
71150917|NCT00847210|141793925|SUPERIORITY_OR_OTHER||Ratio of the dose-normalized AUC(0-tlqc)|1.158||||0.402|TWO_SIDED|90.0|0.864|1.551|||ANOVA||Ninety percent confidence intervals for assessing the dose proportionality of dexlansoprazole AUC(0-tlqc) between regimens were computed based on the frame work of ANOVA.|This study was not powered for any hypothesis testing. For Tmax, an ANOVA model was fitted that included fixed effect of age group (12-14 years and 15 17 years), regimen and interaction of age group and regimen. If the interaction term was not statistically significant, it was not included in the final model. The site effect was also tested in the model, and was not included in the final model if it was not statistically significant (P\>0.05). Pairwise comparisons between regimens were conducted.||1.551|0.864|0.402
71150918|NCT00847210|141793926|SUPERIORITY_OR_OTHER||Ratio of the central values for dose-nor|1.168||||0.388|TWO_SIDED|90.0|0.864|1.579|||ANOVA||Ninety percent confidence intervals for assessing the dose proportionality of dexlansoprazole AUC(0-24) between regimens were computed based on the frame work of ANOVA.|This study was not powered for any hypothesis testing. For Tmax, an ANOVA model was fitted that included fixed effect of age group (12-14 years and 15 17 years), regimen and interaction of age group and regimen. If the interaction term was not statistically significant, it was not included in the final model. The site effect was also tested in the model, and was not included in the final model if it was not statistically significant (P\>0.05). Pairwise comparisons between regimens were conducted.||1.579|0.864|0.388
70876226|NCT02564042|141236509|OTHER||Proportion difference|30.0|||||TWO_SIDED|95.0|0.2|56.5|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 14 has been presented|||56.5|0.2|
70876227|NCT02564042|141236509|OTHER||Proportion difference|42.9|||||TWO_SIDED|95.0|14.4|66.5|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 14 has been presented|||66.5|14.4|
71150919|NCT01721044|141793960|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.001
71150920|NCT01721044|141793961|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
71150921|NCT01721044|141793962|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
71150922|NCT01721044|141793963|SUPERIORITY_OR_OTHER_LEGACY|||||||0.14|||||||Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.140
71150923|NCT01721044|141793964|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.001
71150924|NCT01721044|141793965|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
71150925|NCT01721044|141793966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
71150926|NCT01721044|141793967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.723|||||||Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.723
71150927|NCT01721044|141793968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided \<=0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.001
71150928|NCT01721044|141793968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided \<=0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.001
71150929|NCT01721044|141793969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 12||||0.001
71150930|NCT01721044|141793969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 12||||0.002
71150931|NCT01721044|141793969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 24||||0.001
71150932|NCT01721044|141793969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 24||||0.015
71150933|NCT01721044|141793970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 12||||0.002
71150934|NCT01721044|141793970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 12||||0.001
71150935|NCT01721044|141793970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 24||||0.001
71150936|NCT01721044|141793970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 24||||0.001
71150937|NCT01721044|141793971|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
71150938|NCT01721044|141793971|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
71150939|NCT01721044|141793972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
71150940|NCT01721044|141793972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.009
71150941|NCT01721044|141793973|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
71150942|NCT01721044|141793973|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.003
71150943|NCT01721044|141793974|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.012
71150944|NCT01721044|141793974|SUPERIORITY_OR_OTHER_LEGACY|||||||0.104|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.104
71150945|NCT01721044|141793975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Wilcoxon (Mann-Whitney)|||||||0.002
70876228|NCT02564042|141236509|OTHER||Proportion difference|52.0|||||TWO_SIDED|95.0|23.2|74.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 16 has been presented|||74.4|23.2|
70876229|NCT02564042|141236509|OTHER||Proportion difference|52.4|||||TWO_SIDED|95.0|24.4|74.0|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 16 has been presented|||74.0|24.4|
70876230|NCT02564042|141236509|OTHER||Proportion difference|35.6|||||TWO_SIDED|95.0|6.3|60.5|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 16 has been presented|||60.5|6.3|
70876231|NCT02564042|141236509|OTHER||Proportion difference|48.3|||||TWO_SIDED|95.0|19.7|71.1|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 16 has been presented|||71.1|19.7|
71150946|NCT01721044|141793975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Wilcoxon (Mann-Whitney)|||||||0.004
71150947|NCT01721044|141793976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
71150948|NCT01721044|141793976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.018
71150949|NCT01721044|141793977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
71150950|NCT01721044|141793977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
71150951|NCT01721044|141793978|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12||||0.005
71150952|NCT01721044|141793978|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12||||0.004
71150953|NCT01721044|141793978|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24||||0.002
71150954|NCT01721044|141793978|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24||||0.026
71150955|NCT01721044|141793979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.448|TWO_SIDED||||||ANCOVA|||MCS Week 12||||0.448
71150956|NCT01721044|141793979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.058|TWO_SIDED||||||ANCOVA|||MCS Week 12||||0.058
71150957|NCT01721044|141793979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.446|TWO_SIDED||||||ANCOVA|||MCS Week 24||||0.446
71150958|NCT01721044|141793979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.401|TWO_SIDED||||||ANCOVA|||MCS Week 24||||0.401
71150959|NCT01721044|141793979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||ANCOVA|||PCS Week 12||||0.001
71150960|NCT01721044|141793979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||ANCOVA|||PCS Week 12||||0.001
71150961|NCT01721044|141793979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||ANCOVA|||PCS Week 24||||0.001
71150962|NCT01721044|141793979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||ANCOVA|||PCS Week 24||||0.001
71150963|NCT01721044|141793980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12, US Algorithm||||0.001
71150964|NCT01721044|141793980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12, US Algorithm||||0.001
71150965|NCT01721044|141793980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24, US Algorithm||||0.001
71150966|NCT01721044|141793980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24, US Algorithm||||0.003
71150967|NCT01721044|141793980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12, UK Algorithm||||0.001
71150968|NCT01721044|141793980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12, UK Algorithm||||0.001
71150969|NCT01721044|141793980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24, UK Algorithm||||0.001
71150970|NCT01721044|141793980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24, UK Algorithm||||0.002
71150971|NCT01721044|141793981|SUPERIORITY_OR_OTHER_LEGACY|||||||0.362|TWO_SIDED||||||ANCOVA|||Absenteeism Week 12||||0.362
71150972|NCT01721044|141793981|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17|TWO_SIDED||||||ANCOVA|||Absenteeism Week 12||||0.170
71150973|NCT01721044|141793981|SUPERIORITY_OR_OTHER_LEGACY|||||||0.753|TWO_SIDED||||||ANCOVA|||Absenteeism Week 24||||0.753
71150974|NCT01721044|141793981|SUPERIORITY_OR_OTHER_LEGACY|||||||0.715|TWO_SIDED||||||ANCOVA|||Absenteeism Week 24||||0.715
71150975|NCT01721044|141793981|SUPERIORITY_OR_OTHER_LEGACY|||||||0.077|TWO_SIDED||||||ANCOVA|||Presenteeism Week 12||||0.077
71150976|NCT01721044|141793981|SUPERIORITY_OR_OTHER_LEGACY|||||||0.058|TWO_SIDED||||||ANCOVA|||Presenteeism Week 12||||0.058
71150977|NCT01721044|141793981|SUPERIORITY_OR_OTHER_LEGACY|||||||0.232|TWO_SIDED||||||ANCOVA|||Presenteeism Week 24||||0.232
71150978|NCT01721044|141793981|SUPERIORITY_OR_OTHER_LEGACY|||||||0.534|TWO_SIDED||||||ANCOVA|||Presenteeism Week 24||||0.534
71150979|NCT01721044|141793981|SUPERIORITY_OR_OTHER_LEGACY|||||||0.079|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Week 12||||0.079
71150980|NCT01721044|141793981|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Week 12||||0.070
71150981|NCT01721044|141793981|SUPERIORITY_OR_OTHER_LEGACY|||||||0.327|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Week 24||||0.327
71150982|NCT01721044|141793981|SUPERIORITY_OR_OTHER_LEGACY|||||||0.479|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Week 24||||0.479
71150983|NCT01721044|141793981|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||ANCOVA|||Activity Impairment Week 12||||0.001
71150984|NCT01721044|141793981|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|TWO_SIDED||||||ANCOVA|||Activity Impairment Week 12||||0.005
71150985|NCT01721044|141793981|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||ANCOVA|||Activity Impairment Week 24||||0.001
71150986|NCT01721044|141793981|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|TWO_SIDED||||||ANCOVA|||Activity Impairment Week 24||||0.030
71150987|NCT04032093|141793992|OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.9|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: Before vaccination||1.3|0.9|
71150988|NCT04032093|141793992|OTHER||Geometric Mean Ratio|20.0|||||TWO_SIDED|95.0|16.1|24.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Weeks after vaccination||24.7|16.1|
71150989|NCT04032093|141793992|OTHER||Geometric Mean Ratio|15.6|||||TWO_SIDED|95.0|11.9|20.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after vaccination||20.4|11.9|
71150990|NCT04032093|141793992|OTHER||Geometric Mean Ratio|11.2|||||TWO_SIDED|95.0|8.7|14.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At delivery||14.5|8.7|
71150991|NCT04032093|141793992|OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.9|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: Before vaccination||1.3|0.9|
71150992|NCT04032093|141793992|OTHER||Geometric Mean Ratio|24.2|||||TWO_SIDED|95.0|18.5|31.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Weeks after vaccination||31.7|18.5|
71150993|NCT04032093|141793992|OTHER||Geometric Mean Ratio|20.4|||||TWO_SIDED|95.0|15.7|26.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after vaccination||26.6|15.7|
71150994|NCT04032093|141793992|OTHER||Geometric Mean Ratio|13.6|||||TWO_SIDED|95.0|10.1|18.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At delivery||18.4|10.1|
71150995|NCT04032093|141793992|OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.9|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: Before vaccination||1.3|0.9|
71150996|NCT04032093|141793992|OTHER||Geometric Mean Ratio|19.8|||||TWO_SIDED|95.0|15.3|25.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Weeks after vaccination||25.7|15.3|
71150997|NCT04032093|141793992|OTHER||Geometric Mean Ratio|20.0|||||TWO_SIDED|95.0|15.9|25.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after vaccination||25.1|15.9|
70956543|NCT01160289|141416596|SUPERIORITY_OR_OTHER||LS mean of treatment difference|4.079|STANDARD_ERROR_OF_MEAN|5.566||0.464||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.464
71150998|NCT04032093|141793992|OTHER||Geometric Mean Ratio|15.0|||||TWO_SIDED|95.0|11.9|18.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At delivery||18.9|11.9|
71150999|NCT04032093|141793992|OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.8|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: Before vaccination||1.3|0.8|
70956544|NCT01160289|141416596|SUPERIORITY_OR_OTHER||LS mean of treatment difference|5.054|STANDARD_ERROR_OF_MEAN|5.463||0.356||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.356
70956545|NCT01160289|141416596|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-11.266|STANDARD_ERROR_OF_MEAN|5.418||0.038||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.038
70956546|NCT01160289|141416596|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-10.292|STANDARD_ERROR_OF_MEAN|5.312||0.054||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.054
70956547|NCT01160289|141416596|SUPERIORITY_OR_OTHER||LS mean of treatment difference|4.202|STANDARD_ERROR_OF_MEAN|5.603||0.454||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.454
70956548|NCT01160289|141416596|SUPERIORITY_OR_OTHER||LS mean of treatment difference|5.796|STANDARD_ERROR_OF_MEAN|5.499||0.293||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.293
70956549|NCT01160289|141416596|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-8.808|STANDARD_ERROR_OF_MEAN|5.457||0.107||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.107
70956550|NCT01160289|141416596|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-7.214|STANDARD_ERROR_OF_MEAN|5.349||0.178||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.178
70956551|NCT01160289|141416597|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.079|STANDARD_ERROR_OF_MEAN|0.472||0.867||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.867
70956552|NCT01160289|141416597|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.039|STANDARD_ERROR_OF_MEAN|0.458||0.931||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.931
70956553|NCT01160289|141416597|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.652|STANDARD_ERROR_OF_MEAN|0.46||0.158||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.158
70956554|NCT01160289|141416597|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.612|STANDARD_ERROR_OF_MEAN|0.447||0.172||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.172
70956555|NCT01160289|141416597|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.223|STANDARD_ERROR_OF_MEAN|0.401||0.579||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.579
70956556|NCT01160289|141416597|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.616|STANDARD_ERROR_OF_MEAN|0.39||0.115||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.115
70956557|NCT01160289|141416597|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.168|STANDARD_ERROR_OF_MEAN|0.392||0.668||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.668
70956558|NCT01160289|141416597|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.561|STANDARD_ERROR_OF_MEAN|0.38||0.141||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.141
70956559|NCT01160289|141416597|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.088|STANDARD_ERROR_OF_MEAN|0.258||0.734||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.734
70956560|NCT01160289|141416597|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.179|STANDARD_ERROR_OF_MEAN|0.251||0.477||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.477
70956561|NCT01160289|141416597|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.3|STANDARD_ERROR_OF_MEAN|0.252||0.235||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.235
70956562|NCT01160289|141416597|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.391|STANDARD_ERROR_OF_MEAN|0.245||0.111||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.111
71151000|NCT04032093|141793992|OTHER||Geometric Mean Ratio|22.5|||||TWO_SIDED|95.0|16.9|30.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Weeks after vaccination||30.1|16.9|
71151001|NCT04032093|141793992|OTHER||Geometric Mean Ratio|22.5|||||TWO_SIDED|95.0|17.6|28.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after vaccination||28.7|17.6|
71151002|NCT04032093|141793992|OTHER||Geometric Mean Ratio|16.8|||||TWO_SIDED|95.0|12.7|22.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At delivery||22.3|12.7|
71151003|NCT04032093|141793992|OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.8|1.2|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: Before vaccination||1.2|0.8|
71151004|NCT04032093|141793992|OTHER||Geometric Mean Ratio|21.0|||||TWO_SIDED|95.0|16.6|26.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Weeks after vaccination||26.5|16.6|
71151005|NCT04032093|141793992|OTHER||Geometric Mean Ratio|15.3|||||TWO_SIDED|95.0|11.6|20.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after vaccination||20.1|11.6|
71151006|NCT04032093|141793992|OTHER||Geometric Mean Ratio|10.6|||||TWO_SIDED|95.0|8.1|14.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At delivery||14.0|8.1|
71151007|NCT04032093|141793992|OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.8|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: Before vaccination||1.3|0.8|
71151008|NCT04032093|141793992|OTHER||Geometric Mean Ratio|26.6|||||TWO_SIDED|95.0|20.5|34.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Weeks after vaccination||34.6|20.5|
71151009|NCT04032093|141793992|OTHER||Geometric Mean Ratio|18.0|||||TWO_SIDED|95.0|13.5|24.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after vaccination||24.1|13.5|
71151010|NCT04032093|141793992|OTHER||Geometric Mean Ratio|13.5|||||TWO_SIDED|95.0|10.1|18.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At delivery||18.0|10.1|
71151011|NCT04032093|141793992|OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.9|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: Before vaccination||1.3|0.9|
71151012|NCT04032093|141793992|OTHER||Geometric Mean Ratio|25.0|||||TWO_SIDED|95.0|19.9|31.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Weeks after vaccination||31.3|19.9|
70876232|NCT02564042|141236509|OTHER||Proportion difference|10.0|||||TWO_SIDED|95.0|-36.9|53.9|||||Difference between GSK2894512 1% BID and Vehicle BID at EW has been presented|||53.9|-36.9|
70956563|NCT01160289|141416597|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.349|STANDARD_ERROR_OF_MEAN|0.343||0.31||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.310
71151013|NCT04032093|141793992|OTHER||Geometric Mean Ratio|18.1|||||TWO_SIDED|95.0|14.5|22.8|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after vaccination||22.8|14.5|
71151014|NCT04032093|141793992|OTHER||Geometric Mean Ratio|13.8|||||TWO_SIDED|95.0|10.8|17.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At delivery||17.5|10.8|
71151015|NCT04032093|141793992|OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.9|1.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: Before vaccination||1.4|0.9|
71151016|NCT04032093|141793992|OTHER||Geometric Mean Ratio|34.7|||||TWO_SIDED|95.0|27.0|44.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Weeks after vaccination||44.4|27.0|
71151017|NCT04032093|141793992|OTHER||Geometric Mean Ratio|23.2|||||TWO_SIDED|95.0|18.2|29.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after vaccination||29.6|18.2|
71151018|NCT04032093|141793992|OTHER||Geometric Mean Ratio|16.2|||||TWO_SIDED|95.0|12.0|21.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At delivery||21.7|12.0|
71151019|NCT04032093|141793994|OTHER||Geometric Mean Ratio|10.7|||||TWO_SIDED|95.0|8.1|14.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At birth||14.1|8.1|
71151020|NCT04032093|141793994|OTHER||Geometric Mean Ratio|8.9|||||TWO_SIDED|95.0|5.5|14.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after birth||14.5|5.5|
71151021|NCT04032093|141793994|OTHER||Geometric Mean Ratio|15.8|||||TWO_SIDED|95.0|10.7|23.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Months after birth||23.4|10.7|
71151022|NCT04032093|141793994|OTHER||Geometric Mean Ratio|5.6|||||TWO_SIDED|95.0|3.5|9.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 4 Months after birth||9.0|3.5|
71151023|NCT04032093|141793994|OTHER||Geometric Mean Ratio|6.6|||||TWO_SIDED|95.0|4.5|9.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 6 Months after birth||9.6|4.5|
71151024|NCT04032093|141793994|OTHER||Geometric Mean Ratio|14.9|||||TWO_SIDED|95.0|11.1|19.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At birth||19.9|11.1|
71151025|NCT04032093|141793994|OTHER||Geometric Mean Ratio|11.0|||||TWO_SIDED|95.0|6.5|18.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after birth||18.6|6.5|
71151026|NCT04032093|141793994|OTHER||Geometric Mean Ratio|19.2|||||TWO_SIDED|95.0|13.1|28.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Months after birth||28.0|13.1|
71151027|NCT04032093|141793994|OTHER||Geometric Mean Ratio|6.9|||||TWO_SIDED|95.0|4.2|11.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 4 Months after birth||11.4|4.2|
71151028|NCT04032093|141793994|OTHER||Geometric Mean Ratio|7.3|||||TWO_SIDED|95.0|4.5|11.8|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 6 Months after birth||11.8|4.5|
71151029|NCT04032093|141793994|OTHER||Geometric Mean Ratio|10.8|||||TWO_SIDED|95.0|8.3|14.2|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At birth||14.2|8.3|
71151030|NCT04032093|141793994|OTHER||Geometric Mean Ratio|9.7|||||TWO_SIDED|95.0|6.5|14.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after birth||14.5|6.5|
71151031|NCT04032093|141793994|OTHER||Geometric Mean Ratio|10.6|||||TWO_SIDED|95.0|7.1|15.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Months after birth||15.9|7.1|
71151032|NCT04032093|141793994|OTHER||Geometric Mean Ratio|8.2|||||TWO_SIDED|95.0|5.2|12.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 4 Months after birth||12.9|5.2|
71151033|NCT04032093|141793994|OTHER||Geometric Mean Ratio|4.8|||||TWO_SIDED|95.0|3.1|7.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 6 Months after birth||7.5|3.1|
71151034|NCT04032093|141793994|OTHER||Geometric Mean Ratio|14.0|||||TWO_SIDED|95.0|10.5|18.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At birth||18.7|10.5|
71151035|NCT04032093|141793994|OTHER||Geometric Mean Ratio|11.8|||||TWO_SIDED|95.0|7.4|18.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after birth||18.7|7.4|
71151036|NCT04032093|141793994|OTHER||Geometric Mean Ratio|11.9|||||TWO_SIDED|95.0|7.7|18.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Months after birth||18.3|7.7|
71151037|NCT04032093|141793994|OTHER||Geometric Mean Ratio|8.9|||||TWO_SIDED|95.0|5.5|14.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 4 Months after birth||14.5|5.5|
71151038|NCT04032093|141793994|OTHER||Geometric Mean Ratio|5.4|||||TWO_SIDED|95.0|3.3|8.8|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 6 Months after birth||8.8|3.3|
71151039|NCT04032093|141793994|OTHER||Geometric Mean Ratio|9.5|||||TWO_SIDED|95.0|7.4|12.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At birth||12.3|7.4|
71151040|NCT04032093|141793994|OTHER||Geometric Mean Ratio|8.4|||||TWO_SIDED|95.0|5.7|12.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after birth||12.4|5.7|
71151041|NCT04032093|141793994|OTHER||Geometric Mean Ratio|9.9|||||TWO_SIDED|95.0|6.4|15.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Months after birth||15.4|6.4|
71151042|NCT04032093|141793994|OTHER||Geometric Mean Ratio|4.5|||||TWO_SIDED|95.0|2.9|6.8|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 4 Months after birth||6.8|2.9|
71151043|NCT04032093|141793994|OTHER||Geometric Mean Ratio|4.0|||||TWO_SIDED|95.0|2.5|6.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 6 Months after birth||6.3|2.5|
71151044|NCT04032093|141793994|OTHER||Geometric Mean Ratio|12.4|||||TWO_SIDED|95.0|9.2|16.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At birth||16.6|9.2|
71151045|NCT04032093|141793994|OTHER||Geometric Mean Ratio|11.3|||||TWO_SIDED|95.0|7.1|17.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after birth||17.9|7.1|
71151046|NCT04032093|141793994|OTHER||Geometric Mean Ratio|10.4|||||TWO_SIDED|95.0|7.0|15.2|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Months after birth||15.2|7.0|
71151047|NCT04032093|141793994|OTHER||Geometric Mean Ratio|5.7|||||TWO_SIDED|95.0|3.7|9.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 4 Months after birth||9.0|3.7|
71151048|NCT04032093|141793994|OTHER||Geometric Mean Ratio|4.3|||||TWO_SIDED|95.0|2.7|7.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 6 Months after birth||7.0|2.7|
71151049|NCT04032093|141793994|OTHER||Geometric Mean Ratio|11.3|||||TWO_SIDED|95.0|8.6|14.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At birth||14.9|8.6|
70876233|NCT02564042|141236509|OTHER||Proportion difference|42.9|||||TWO_SIDED|95.0|-6.3|81.6|||||Difference between GSK2894512 1% QD and Vehicle QD at EW has been presented|||81.6|-6.3|
71151050|NCT04032093|141793994|OTHER||Geometric Mean Ratio|10.2|||||TWO_SIDED|95.0|7.4|14.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after birth||14.0|7.4|
71151051|NCT04032093|141793994|OTHER||Geometric Mean Ratio|15.0|||||TWO_SIDED|95.0|10.2|22.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Months after birth||22.1|10.2|
70876234|NCT02564042|141236518|OTHER||Proportion difference|-3.6|||||TWO_SIDED|95.0|-28.8|21.9|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 1 has been presented|||21.9|-28.8|
70956564|NCT01160289|141416597|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.568|STANDARD_ERROR_OF_MEAN|0.334||0.09||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.090
70956565|NCT01160289|141416597|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.729|STANDARD_ERROR_OF_MEAN|0.335||0.03||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.030
70956566|NCT01160289|141416597|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.948|STANDARD_ERROR_OF_MEAN|0.326||0.004||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.004
70956567|NCT01160289|141416599|SUPERIORITY_OR_OTHER|||||||0.656||||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level \<340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.656
70956568|NCT01160289|141416599|SUPERIORITY_OR_OTHER|||||||0.46||||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level \<340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.460
70956569|NCT01160289|141416599|SUPERIORITY_OR_OTHER|||||||0.198||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level \<340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.198
71151052|NCT04032093|141793994|OTHER||Geometric Mean Ratio|6.1|||||TWO_SIDED|95.0|3.9|9.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 4 Months after birth||9.6|3.9|
71151053|NCT04032093|141793994|OTHER||Geometric Mean Ratio|4.5|||||TWO_SIDED|95.0|2.9|6.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 6 Months after birth||6.9|2.9|
70956570|NCT01160289|141416599|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.009
70956571|NCT01160289|141416599|SUPERIORITY_OR_OTHER|||||||0.671||||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.671
70956572|NCT01160289|141416599|SUPERIORITY_OR_OTHER|||||||0.259||||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.259
70956573|NCT01160289|141416599|SUPERIORITY_OR_OTHER|||||||0.441||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.441
70956574|NCT01160289|141416599|SUPERIORITY_OR_OTHER|||||||0.433||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.433
70956575|NCT01160289|141416600|SUPERIORITY_OR_OTHER||LS mean of treatment difference|0.13||||0.423||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.423
70956576|NCT01160289|141416600|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.12||||0.443||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.443
70956577|NCT01160289|141416600|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.084||||0.599||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.599
70956578|NCT01160289|141416600|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.334||||0.029||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.029
70956579|NCT01160289|141416601|SUPERIORITY_OR_OTHER||LS Mean of treatment difference|-0.152||||0.148||95.0||||The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.148
70956580|NCT01160289|141416601|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.216||||0.033||95.0||||The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.033
70956581|NCT01160289|141416601|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.124||||0.224||95.0||||The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.224
70956582|NCT01160289|141416601|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.189||||0.056||95.0||||The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.056
71151054|NCT04032093|141793994|OTHER||Geometric Mean Ratio|16.2|||||TWO_SIDED|95.0|12.5|21.2|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At birth||21.2|12.5|
70956583|NCT01160289|141416601|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.211||||0.031||95.0||||The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.031
70956584|NCT01160289|141416601|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.227||||0.017||95.0||||The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.017
70956585|NCT01160289|141416601|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.016||||0.866||95.0||||The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.866
70956586|NCT01160289|141416601|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.032||||0.726||95.0||||The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.726
70956587|NCT01160289|141416602|SUPERIORITY_OR_OTHER||LS Mean of treatment difference|-9.014|||<|0.001||95.0||||The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||<0.001
71151055|NCT04032093|141793994|OTHER||Geometric Mean Ratio|12.8|||||TWO_SIDED|95.0|8.6|19.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after birth||19.1|8.6|
70956588|NCT01160289|141416602|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-18.547|||<|0.001||95.0||||The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||<0.001
70956589|NCT01160289|141416602|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-9.216|||<|0.001||95.0||||The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||<0.001
71151056|NCT04032093|141793994|OTHER||Geometric Mean Ratio|17.7|||||TWO_SIDED|95.0|11.9|26.2|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Months after birth||26.2|11.9|
71151057|NCT04032093|141793994|OTHER||Geometric Mean Ratio|9.0|||||TWO_SIDED|95.0|5.7|14.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 4 Months after birth||14.4|5.7|
71151058|NCT04032093|141793994|OTHER||Geometric Mean Ratio|6.2|||||TWO_SIDED|95.0|3.9|9.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 6 Months after birth||9.9|3.9|
71151059|NCT02952820|141794006|SUPERIORITY||least squares geometric mean (LSGM)ratio|0.732|||<|0.0001|TWO_SIDED|95.0|0.636|0.843|||Mixed Models Analysis|||Analysis was based on mixed effect model repeated measurement analysis (MMRM) model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (missing not at random/complete case missing value \[MNAR/CCMV\]).||0.843|0.636|<.0001
71151060|NCT02952820|141794006|SUPERIORITY||LSGM ratio|0.701|||<|0.0001|TWO_SIDED|95.0|0.607|0.81|||Mixed Models Analysis|||Analysis was based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.810|0.607|<.0001
71151061|NCT02952820|141794007|SUPERIORITY||LSGM ratio|0.781|||<|0.0001|TWO_SIDED|95.0|0.725|0.842|||Mixed Models Analysis|||First 7 nights after the first dose (Statistical analysis 1): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.842|0.725|<.0001
71151062|NCT02952820|141794007|SUPERIORITY||LSGM ratio|0.752|||<|0.0001|TWO_SIDED|95.0|0.698|0.811|||Mixed Models Analysis|||First 7 nights after the first dose (Statistical analysis 2): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.811|0.698|<.0001
71151063|NCT02952820|141794007|SUPERIORITY||LSGM ratio|0.81|||<|0.0001|TWO_SIDED|95.0|0.735|0.893|||Mixed Models Analysis|||Month 1 (Statistical analysis 3): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.893|0.735|<.0001
71151064|NCT02952820|141794007|SUPERIORITY||LSGM ratio|0.77|||<|0.0001|TWO_SIDED|95.0|0.698|0.848|||Mixed Models Analysis|||Month 1 (Statistical analysis 4): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.848|0.698|<.0001
71151065|NCT02952820|141794007|SUPERIORITY||LSGM ratio|0.778|||<|0.0001|TWO_SIDED|95.0|0.69|0.878|||Mixed Models Analysis|||Month 3 (Statistical analysis 5): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.878|0.690|<.0001
71151066|NCT02952820|141794007|SUPERIORITY||LSGM ratio|0.77|||<|0.0001|TWO_SIDED|95.0|0.681|0.869|||Mixed Models Analysis|||Month 3 (Statistical analysis 6): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.869|0.681|<.0001
71151067|NCT02952820|141794008|SUPERIORITY||LSM Difference|4.299|STANDARD_ERROR_OF_MEAN|0.848|<|0.0001|TWO_SIDED|95.0|2.638|5.961|||Mixed Models Analysis|||First 7 nights (Statistical analysis 1): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||5.961|2.638|<.0001
70956590|NCT01160289|141416602|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-18.75|||<|0.001||95.0||||The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||<0.001
71151068|NCT02952820|141794008|SUPERIORITY||LSM Difference|5.793|STANDARD_ERROR_OF_MEAN|0.846|<|0.0001|TWO_SIDED|95.0|4.133|7.452|||Mixed Models Analysis|||First 7 nights (Statistical analysis 2): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||7.452|4.133|<.0001
71151069|NCT02952820|141794008|SUPERIORITY||LSM Difference|2.227|STANDARD_ERROR_OF_MEAN|0.979||0.023|TWO_SIDED|95.0|0.307|4.146|||Mixed Models Analysis|||Month 1 (Statistical analysis 3): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||4.146|0.307|0.0230
71151070|NCT02952820|141794008|SUPERIORITY||LSM Difference|3.615|STANDARD_ERROR_OF_MEAN|1.01||0.0003|TWO_SIDED|95.0|1.635|5.595|||Mixed Models Analysis|||Month 1 (Statistical analysis 4): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||5.595|1.635|0.0003
71151071|NCT02952820|141794008|SUPERIORITY||LSM Difference|4.222|STANDARD_ERROR_OF_MEAN|1.099||0.0001|TWO_SIDED|95.0|2.068|6.377|||Mixed Models Analysis|||Month 3 (Statistical analysis 5): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||6.377|2.068|0.0001
71151072|NCT02952820|141794008|SUPERIORITY||LSM Difference|4.361|STANDARD_ERROR_OF_MEAN|1.092|<|0.0001|TWO_SIDED|95.0|2.22|6.501|||Mixed Models Analysis|||Month 3 (Statistical analysis 6): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||6.501|2.220|<.0001
71151073|NCT02952820|141794008|SUPERIORITY||LSM Difference|4.549|STANDARD_ERROR_OF_MEAN|1.179||0.0001|TWO_SIDED|95.0|2.236|6.861|||Mixed Models Analysis|||Month 6 (Statistical analysis 7): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||6.861|2.236|0.0001
71151074|NCT02952820|141794008|SUPERIORITY||LSM Difference|4.667|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|2.373|6.96|||Mixed Models Analysis|||Month 6 (Statistical analysis 8): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||6.960|2.373|<.0001
71151075|NCT02952820|141794009|SUPERIORITY||Least square mean (LSM) Difference|-14.328|STANDARD_ERROR_OF_MEAN|3.614|<|0.0001|TWO_SIDED|95.0|-21.411|-7.245|||Mixed Models Analysis|||First 7 nights (Statistical analysis 1): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||-7.245|-21.411|<.0001
71151076|NCT02952820|141794009|SUPERIORITY||LSM Difference|-16.72|STANDARD_ERROR_OF_MEAN|3.619|<|0.0001|TWO_SIDED|95.0|-23.813|-9.626|||Mixed Models Analysis|||First 7 nights (Statistical analysis 2): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||-9.626|-23.813|<.0001
71151077|NCT02952820|141794009|SUPERIORITY||LSM Difference|-5.514|STANDARD_ERROR_OF_MEAN|4.109||0.1796|TWO_SIDED|95.0|-13.568|2.54|||Mixed Models Analysis|||Month 1 (Statistical analysis 3): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||2.540|-13.568|0.1796
71151078|NCT02952820|141794009|SUPERIORITY||LSM Difference|-7.005|STANDARD_ERROR_OF_MEAN|4.129||0.0898|TWO_SIDED|95.0|-15.098|1.088|||Mixed Models Analysis|||Month 1 (Statistical analysis 4): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||1.088|-15.098|0.0898
70876235|NCT02564042|141236518|OTHER||Proportion difference|-0.3|||||TWO_SIDED|95.0|-25.4|25.1|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 1 has been presented|||25.1|-25.4|
70956591|NCT01160289|141416602|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.977||||0.776||95.0||||The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.776
70956592|NCT01160289|141416602|SUPERIORITY_OR_OTHER||LS mean of treatment difference|0.78||||0.814||95.0||||The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.814
70956593|NCT01160289|141416602|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-1.629||||0.627||95.0||||The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.627
70956594|NCT01160289|141416602|SUPERIORITY_OR_OTHER||LS mean of treatment difference|0.128||||0.968||95.0||||The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.968
70956595|NCT01160289|141416603|SUPERIORITY_OR_OTHER||LS Mean of treatment difference|-0.006||||0.984||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.984
70956596|NCT01160289|141416603|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.465||||0.076||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.076
70956597|NCT01160289|141416603|SUPERIORITY_OR_OTHER||LS mean of treatment difference|0.387||||0.142||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.142
70956598|NCT01160289|141416603|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.072||||0.776||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.776
71151079|NCT02952820|141794009|SUPERIORITY||LSM Difference|-13.424|STANDARD_ERROR_OF_MEAN|4.486||0.0028|TWO_SIDED|95.0|-22.218|-4.631|||Mixed Models Analysis|||Month 3 (Statistical analysis 5): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||-4.631|-22.218|0.0028
70956599|NCT01160289|141416604|SUPERIORITY_OR_OTHER||LS Mean of treatment difference|5.031||||0.103||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.103
70956600|NCT01160289|141416604|SUPERIORITY_OR_OTHER||LS mean treatment difference|-3.225||||0.277||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.277
70956601|NCT01160289|141416604|SUPERIORITY_OR_OTHER||LS mean of treatment difference|7.056||||0.019||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.019
70956602|NCT01160289|141416604|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-1.201||||0.676||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.676
70956603|NCT04193436|141416607|OTHER||Ratio (%) of Adjusted Means|92.89|||||TWO_SIDED|90.0|68.15|126.6||||||The effect of the hepatic impairment on PK parameter AUCinf were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way analysis of variance (ANOVA) model based on natural log transformed data.||126.60|68.15|
70956604|NCT04193436|141416607|OTHER||Ratio (%) of Adjusted Means|134.4|||||TWO_SIDED|90.0|98.61|183.17||||||The effect of the hepatic impairment on PK parameter AUCinf were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||183.17|98.61|
70956605|NCT04193436|141416607|OTHER||Ratio (%) of Adjusted Means|139.33|||||TWO_SIDED|90.0|100.69|192.78||||||The effect of the hepatic impairment on PK parameter AUCinf were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||192.78|100.69|
70956606|NCT04193436|141416608|OTHER||Ratio (%) of Adjusted Means|87.2|||||TWO_SIDED|90.0|63.61|119.53||||||The effect of the hepatic impairment on PK parameter Cmax were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||119.53|63.61|
70956607|NCT04193436|141416608|OTHER||Ratio (%) of Adjusted Means|102.24|||||TWO_SIDED|90.0|74.59|140.15||||||The effect of the hepatic impairment on PK parameter Cmax were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||140.15|74.59|
70956608|NCT04193436|141416608|OTHER||Ratio (%) of Adjusted Means|83.78|||||TWO_SIDED|90.0|60.18|116.62||||||The effect of the hepatic impairment on PK parameter Cmax were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||116.62|60.18|
70956609|NCT04193436|141416609|OTHER||Ratio (%) of Adjusted Means|121.81|||||TWO_SIDED|90.0|88.69|167.31||||||The effect of the hepatic impairment on PK parameter AUCinf,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||167.31|88.69|
70956610|NCT04193436|141416609|OTHER||Ratio (%) of Adjusted Means|178.5|||||TWO_SIDED|90.0|129.96|245.18||||||The effect of the hepatic impairment on PK parameter AUCinf,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||245.18|129.96|
70956611|NCT04193436|141416609|OTHER||Ratio (%) of Adjusted Means|195.73|||||TWO_SIDED|90.0|140.31|273.03||||||The effect of the hepatic impairment on PK parameter AUCinf,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||273.03|140.31|
71151080|NCT02952820|141794009|SUPERIORITY||LSM Difference|-10.079|STANDARD_ERROR_OF_MEAN|4.578||0.0277|TWO_SIDED|95.0|-19.053|-1.104|||Mixed Models Analysis|||Month 3 (Statistical analysis 6): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||-1.104|-19.053|0.0277
70956612|NCT04193436|141416610|OTHER||Ratio (%) of Adjusted Means|114.45|||||TWO_SIDED|90.0|88.13|148.63||||||The effect of the hepatic impairment on PK parameter Cmax,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||148.63|88.13|
70956613|NCT04193436|141416610|OTHER||Ratio (%) of Adjusted Means|136.04|||||TWO_SIDED|90.0|104.75|176.67||||||The effect of the hepatic impairment on PK parameter Cmax,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||176.67|104.75|
70956614|NCT04193436|141416610|OTHER||Ratio (%) of Adjusted Means|117.87|||||TWO_SIDED|90.0|89.61|155.03||||||The effect of the hepatic impairment on PK parameter Cmax,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||155.03|89.61|
70956615|NCT03292432|141416615|SUPERIORITY||Risk Difference (RD)|-3.5||||0.8|TWO_SIDED|95.0|-21.8|15.2|||Fisher Exact||Risk difference reflects percentage of participants achieving HIV-1 RNA \< 50 copies/mL in TERA arm minus SOC arm|||15.2|-21.8|0.80
70956616|NCT03292432|141416616|SUPERIORITY||Risk Difference (RD)|-0.7|||>|0.99|TWO_SIDED|95.0|-20.9|19.6|||Fisher Exact||Risk difference reflects percentage of participants achieving HIV-1 RNA \< 200 copies/ml in TERA arm minus SOC arm|||19.6|-20.9|>0.99
70956617|NCT03292432|141416617|SUPERIORITY||Risk Difference (RD)|-13.1||||0.24|TWO_SIDED|95.0|-32.1|7.2|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 in TERA arm minus SOC arm|Comparison of percentages at Week 24||7.2|-32.1|0.24
70956618|NCT03292432|141416617|SUPERIORITY||Risk Difference (RD)|3.8||||0.76|TWO_SIDED|95.0|-16.0|22.6|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 36 in TERA arm minus SOC arm|Comparison of percentages at Week 36||22.6|-16.0|0.76
70956619|NCT03292432|141416617|SUPERIORITY||Risk Difference (RD)|3.6|||>|0.99|TWO_SIDED|95.0|-21.8|27.4|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 in TERA arm minus SOC arm|Comparison of percentages at Week 48||27.4|-21.8|>0.99
70956620|NCT03292432|141416618|SUPERIORITY||Risk Difference (RD)|-13.0||||0.26|TWO_SIDED|95.0|-32.7|7.3|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 200 copies/mL at Week 24 in TERA arm minus SOC arm|Comparison of percentages at Week 24||7.3|-32.7|0.26
70956621|NCT03292432|141416618|SUPERIORITY||Risk Difference (RD)|11.5||||0.42|TWO_SIDED|95.0|-11.2|32.8|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 200 copies/mL at Week 36 in TERA arm minus SOC arm|Comparison of percentages at Week 36||32.8|-11.2|0.42
71151081|NCT02952820|141794009|SUPERIORITY||LSM Difference|-17.474|STANDARD_ERROR_OF_MEAN|5.014||0.0005|TWO_SIDED|95.0|-27.306|-7.643|||Mixed Models Analysis|||Month 6 (Statistical analysis 7): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||-7.643|-27.306|0.0005
70956622|NCT03292432|141416618|SUPERIORITY||Risk Difference (RD)|-4.4||||0.77|TWO_SIDED|95.0|-29.5|20.7|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 200 copies/mL at Week 48 in TERA arm minus SOC arm|Comparison of percentages at Week 48||20.7|-29.5|0.77
70956623|NCT03292432|141416619|SUPERIORITY||Risk Difference (RD)|5.8||||0.67|TWO_SIDED|95.0|-14.6|25.3|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 200 copies/mL at Week 12 and maintained to Week 48 in TERA arm minus SOC arm|||25.3|-14.6|0.67
70956624|NCT03292432|141416620|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of percentages of doses taken from Weeks 0 -12||||<0.001
70956625|NCT03292432|141416620|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of percentage of doses taken from Weeks \>12 to 24||||<0.001
70956626|NCT03292432|141416620|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Comparison of percentage of doses taken from Weeks \>24 to 36||||0.06
70956627|NCT03292432|141416620|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Comparison of percentage of doses taken from Weeks \>36 to 48||||0.50
70956628|NCT03292432|141416621|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of percentage of doses taken on time from Weeks 0 - 12||||<0.001
71151082|NCT02952820|141794009|SUPERIORITY||LSM Difference|-12.671|STANDARD_ERROR_OF_MEAN|4.951||0.0105|TWO_SIDED|95.0|-22.378|-2.964|||Mixed Models Analysis|||Month 6 (Statistical analysis 8): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||-2.964|-22.378|0.0105
70956629|NCT03292432|141416621|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of percentage of doses taken on time from Weeks \>12 - 24||||<0.001
70956630|NCT03292432|141416621|SUPERIORITY|||||||0.05||||||p-value equal to a priori threshold for statistical significance|Wilcoxon (Mann-Whitney)|||Comparison of percentages of doses taken on time from Weeks \>24 - 36||||0.05
70956631|NCT03292432|141416621|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||Comparison of doses taken on time from Weeks \>36 - 48||||0.49
70956632|NCT03292432|141416622|SUPERIORITY||Risk Ratio (RR)|2.51|||<|0.001|TWO_SIDED|95.0|1.9|3.33|||Chi-squared|Pearson Chi-square test from generalized linear model with Poisson link|Risk ratio for SOC arm relative to TERA arm|Comparison of incidence rates from Weeks 0 - 12||3.33|1.90|<0.001
70956633|NCT03292432|141416622|SUPERIORITY||Risk Ratio (RR)|1.56|||<|0.001|TWO_SIDED|95.0|1.29|1.89|||Chi-squared|Pearson Chi-square test from generalized linear model with Poisson link|Risk ratio for SOC arm relative to TERA arm|Comparison of incidence rates from Weeks \>12 - 24||1.89|1.29|<0.001
70956634|NCT03292432|141416622|SUPERIORITY||Risk Ratio (RR)|1.23||||0.02|TWO_SIDED|95.0|1.03|1.47|||Chi-squared|Pearson Chi-square test from generalized linear model with Poisson link|P-value from Pearson Chi-square test from generalized linear model with Poisson link|Comparison of incidence rates from Weeks \>24 - 36||1.47|1.03|0.020
70956635|NCT03292432|141416622|SUPERIORITY||Risk Ratio (RR)|1.08||||0.39|TWO_SIDED|95.0|0.9|1.3|||Chi-squared|Pearson Chi-square test from generalized linear model with Poisson link|Risk ratio for SOC arm relative to TERA arm|Comparison of incidence rates from Weeks \>36 - 48||1.30|0.90|0.39
70956636|NCT03292432|141416623|SUPERIORITY||Risk Difference (RD)|2.3|||>|0.99|TWO_SIDED|95.0|-16.4|21.1|||Fisher Exact||Risk difference reflects percentage of participants achieving HIV-1 RNA \< 200 copies/mL in TERA arm minus SOC arm|||21.1|-16.4|>0.99
70956637|NCT03292432|141416624|SUPERIORITY||Risk Difference (RD)|4.7||||0.71|TWO_SIDED|95.0|-9.0|19.4|||Fisher Exact||Risk difference reflects percentage of participants achieving sustained virologic control in TERA arm minus SOC arm|||19.4|-9.0|0.71
71151083|NCT02952820|141794010|SUPERIORITY||LSM Difference|22.034|STANDARD_ERROR_OF_MEAN|4.354|<|0.0001|TWO_SIDED|95.0|13.488|30.579|||Mixed Models Analysis|||First 7 Nights After the First Dose (Statistical analysis 1): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||30.579|13.488|<.0001
70956638|NCT01014143|141416627|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70956639|NCT02029872|141416628|OTHER|The study was powered for enrollment of 100 subjects with MRSA colonization at baseline. Despite substantial screening, we were unable to enroll enough subjects to meet the necessary sample size.||||||||||||||||Due to low enrollment in the intervention, statistical analysis was not possible.|The study was powered for enrollment of 100 subjects with MRSA colonization at baseline. Despite substantial screening, we were unable to enroll enough subjects to meet the necessary sample size.|||
70956640|NCT03699085|141416642|EQUIVALENCE|A p value of \< 0.05 suggests the groups are different.||||||0.38||||||A p value of \< 0.05 suggests the groups are different.|Wilcoxon (Mann-Whitney)|||Wilcoxon rank-sum test is used, which ranks the values in each group, sums the ranks and determines the probability that they are the same. The probability p-value is reported.||||0.38
70956641|NCT03699085|141416643|SUPERIORITY|Adjusted mixed effects regression models were used to determine whether patients in the intervention and control group manifested different patterns of change in days of heroin use in the past 30 days in terms of incidence-rate ratio. We applied a negative binomial distribution to help account for overdispersion of outcome data.|Incidence rate ratio|1.29||||0.68|TWO_SIDED|95.0|0.38|4.37||A p value of \< 0.05 suggests the groups are different.|Regression, Cox||A number greater than 1.0 indicates a higher incidence rate of heroin use in past 30 days for intervention group compared to control group|Comparison of control and intervention populations based on substance use measured utilizing a time-line follow back (TLFB) calendar administered by the research assistant to for past 30-day heroin use. This is a covariate-adjusted mixed effects regression model at TLFB timepoint of 6 months. A number greater than 1.0 indicates a higher incidence of heroin use in the past 30 days at the 6 month timepoint for intervention group compared to control group.||4.37|0.38|0.68
70956642|NCT02065687|141416677|EQUIVALENCE|The null hypothesis is that there is no relationship between BMI and metformin treatment (i.e. the parameter associated with the interaction term of BMI \* treatment is equal to 0).|Cox Proportional Hazard|-0.01787|STANDARD_ERROR_OF_MEAN|0.27472||0.9482|TWO_SIDED||||||Regression, Cox|||The interaction between BMI and metformin treatment will be examined with an interaction term in a Cox proportional hazards model. Historical data indicate that approximately 50% of people are obese (BMI\>=30). For the purposes of examining the relationship, we will classify patients into two levels (high versus low) at the median BMI, which will increase the likelihood of detecting an interaction between metformin treatment and obesity.||||0.9482
70956643|NCT00652327|141416682|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0026|||||||Wilcoxon rank sum test|||||||.0026
70956644|NCT02926898|141416688|SUPERIORITY||Percent difference|-54.0|||<|0.001|TWO_SIDED|95.0|-67.2|-35.6||Analysis of covariance (ANCOVA) model with treatment group (ZX008 or placebo) and age group (\< 6 years, ≥ 6 years) as factors, and with log baseline frequency as a covariate, and log CSF as the outcome variable.|ANCOVA|||||-35.6|-67.2|<0.001
70956645|NCT02926898|141416689|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|A logistic regression model using a categorical response variable as a function of Treatment group, Baseline seizure frequency, and age group.||||||<0.001
70956646|NCT02926898|141416690|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
70956647|NCT01871805|141416693|SUPERIORITY|||||||0.0056||||||Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.|Exact Clopper-Pearson CI, 2 sided|||||||0.0056
70956648|NCT01871805|141416694|SUPERIORITY|||||||0.0251||||||Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.|Exact Clopper-Pearson CI, 2 sided|||||||0.0251
70956649|NCT01871805|141416694|SUPERIORITY|||||||0.0203||||||Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.|Exact Clopper-Pearson CI, 2 sided|||||||0.0203
71151084|NCT02952820|141794010|SUPERIORITY||LSM Difference|31.796|STANDARD_ERROR_OF_MEAN|4.35|<|0.0001|TWO_SIDED|95.0|23.258|40.334|||Mixed Models Analysis|||First 7 nights after the first dose (Statistical analysis 2): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||40.334|23.258|<.0001
71151085|NCT02952820|141794010|SUPERIORITY||LSM Difference|11.76|STANDARD_ERROR_OF_MEAN|5.269||0.0259|TWO_SIDED|95.0|1.418|22.102|||Mixed Models Analysis|||Month 1 (Statistical analysis 3): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||22.102|1.418|0.0259
71151086|NCT02952820|141794010|SUPERIORITY||LSM Difference|22.131|STANDARD_ERROR_OF_MEAN|5.286|<|0.0001|TWO_SIDED|95.0|11.757|32.505|||Mixed Models Analysis|||Month 1 (Statistical analysis 4): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||32.505|11.757|<.0001
71151087|NCT02952820|141794010|SUPERIORITY||LSM Difference|17.374|STANDARD_ERROR_OF_MEAN|5.906||0.0034|TWO_SIDED|95.0|5.781|28.968|||Mixed Models Analysis|||Month 3 (Statistical analysis 5): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||28.968|5.781|0.0034
71151088|NCT02952820|141794010|SUPERIORITY||LSM Difference|21.686|STANDARD_ERROR_OF_MEAN|5.946||0.0003|TWO_SIDED|95.0|10.014|33.359|||Mixed Models Analysis|||Month 3 (Statistical analysis 6): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||33.359|10.014|0.0003
71151089|NCT02952820|141794010|SUPERIORITY||LSM Difference|18.555|STANDARD_ERROR_OF_MEAN|6.324||0.0034|TWO_SIDED|95.0|6.14|30.969|||Mixed Models Analysis|||Month 6 (Statistical analysis 7): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be missing at random (MAR).||30.969|6.140|0.0034
71151090|NCT02952820|141794010|SUPERIORITY||LSM Difference|22.686|STANDARD_ERROR_OF_MEAN|6.392||0.0004|TWO_SIDED|95.0|10.137|35.234|||Mixed Models Analysis|||Month 6 (Statistical analysis 8): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||35.234|10.137|0.0004
71151091|NCT02952820|141794011|SUPERIORITY||Difference of percentage|13.67||||0.0004|TWO_SIDED|95.0|6.24|21.1|||Cochran-Mantel-Haenszel|||Sleep onset responders: Statistical analysis 1||21.10|6.24|0.0004
71151092|NCT02952820|141794011|SUPERIORITY||Difference of percentage|12.53||||0.0009|TWO_SIDED|95.0|5.2|19.86|||Cochran-Mantel-Haenszel|||Sleep Onset Responders: Statistical analysis 2||19.86|5.20|0.0009
71151093|NCT02952820|141794011|SUPERIORITY||Difference of percentage|14.65||||0.0002|TWO_SIDED|95.0|6.97|22.33|||Cochran-Mantel-Haenszel|||Sleep Maintenance Responders: Statistical analysis 3||22.33|6.97|0.0002
71151094|NCT02952820|141794011|SUPERIORITY||Difference of percentage|9.82||||0.011|TWO_SIDED|95.0|2.29|17.35|||Cochran-Mantel-Haenszel|||Sleep Maintenance Responders: Statistical analysis 4||17.35|2.29|0.0110
71151095|NCT02952820|141794013|SUPERIORITY||LSM Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.287||0.0137|TWO_SIDED|95.0|-1.27|-0.15|||Mixed Models Analysis|||Month 1 (Statistical analysis 1): Based on MMRM model with factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.15|-1.27|0.0137
71151096|NCT02952820|141794013|SUPERIORITY||LSM Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.289||0.0011|TWO_SIDED|95.0|-1.51|-0.38|||Mixed Models Analysis|||Month 1 (Statistical analysis 2): Based on MMRM model with factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.38|-1.51|0.0011
71151097|NCT02952820|141794013|SUPERIORITY||LSM Difference|-1.16|STANDARD_ERROR_OF_MEAN|0.302||0.0001|TWO_SIDED|95.0|-1.75|-0.57|||Mixed Models Analysis|||Month 3 (Statistical analysis 3): Based on MMRM model with factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.57|-1.75|0.0001
71151098|NCT02952820|141794013|SUPERIORITY||LSM Difference|-1.36|STANDARD_ERROR_OF_MEAN|0.305|<|0.0001|TWO_SIDED|95.0|-1.96|-0.76|||Mixed Models Analysis|||Month 3 (Statistical analysis 4): Based on MMRM model with factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.76|-1.96|<.0001
70876236|NCT02564042|141236518|OTHER||Proportion difference|9.4|||||TWO_SIDED|95.0|-17.5|35.3|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 2 has been presented|||35.3|-17.5|
70876237|NCT02564042|141236518|OTHER||Proportion difference|9.1|||||TWO_SIDED|95.0|-15.4|33.3|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 2 has been presented .|||33.3|-15.4|
70876238|NCT02564042|141236518|OTHER||Proportion difference|10.0|||||TWO_SIDED|95.0|-17.1|36.1|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 2 has been presented .|||36.1|-17.1|
70876239|NCT02564042|141236518|OTHER||Proportion difference|6.3|||||TWO_SIDED|95.0|-19.3|31.0|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 2 has been presented|||31.0|-19.3|
71151099|NCT02952820|141794013|SUPERIORITY||LSM Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.302|<|0.0001|TWO_SIDED|95.0|-1.9|-0.71|||Mixed Models Analysis|||Month 6 (Statistical analysis 5): Based on MMRM model with factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.71|-1.90|<.0001
70876240|NCT02564042|141236518|OTHER||Proportion difference|9.7|||||TWO_SIDED|95.0|-18.2|36.7|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 4 has been presented|||36.7|-18.2|
70876241|NCT02564042|141236518|OTHER||Proportion difference|19.4|||||TWO_SIDED|95.0|-6.9|43.6|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 4 has been presented .|||43.6|-6.9|
71151100|NCT02952820|141794013|SUPERIORITY||LSM Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.307|<|0.0001|TWO_SIDED|95.0|-1.92|-0.71|||Mixed Models Analysis|||Month 6 (Statistical analysis 6): Based on MMRM model with factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.71|-1.92|<.0001
71151101|NCT02952820|141794014|SUPERIORITY||LSM Difference|-1.66|STANDARD_ERROR_OF_MEAN|0.905||0.067|TWO_SIDED|95.0|-3.44|0.12|||Mixed Models Analysis|||Month 1 (Statistical analysis 1): Based on MMRM model with factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.||0.12|-3.44|0.0670
71151102|NCT02952820|141794014|SUPERIORITY||LSM Difference|-2.04|STANDARD_ERROR_OF_MEAN|0.913||0.0257|TWO_SIDED|95.0|-3.83|-0.25|||Mixed Models Analysis|||Month 1 (Statistical analysis 2): Based on MMRM model with factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.25|-3.83|0.0257
71151103|NCT02952820|141794014|SUPERIORITY||LSM Difference|-2.18|STANDARD_ERROR_OF_MEAN|0.939||0.0206|TWO_SIDED|95.0|-4.02|-0.34|||Mixed Models Analysis|||Month 3 (Statistical analysis 3): Based on MMRM model with factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.34|-4.02|0.0206
71151104|NCT02952820|141794014|SUPERIORITY||LSM Difference|-3.04|STANDARD_ERROR_OF_MEAN|0.95||0.0014|TWO_SIDED|95.0|-4.91|-1.18|||Mixed Models Analysis|||Month 3 (Statistical analysis 4): Based on MMRM model with factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.||-1.18|-4.91|0.0014
71151105|NCT02952820|141794014|SUPERIORITY||LSM Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.112||0.0134|TWO_SIDED|95.0|-4.48|-0.52|||Mixed Models Analysis|||Month 6 (Statistical analysis 5): Based on MMRM model with factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.52|-4.48|0.0134
71151106|NCT02952820|141794014|SUPERIORITY||LSM Difference|-2.56|STANDARD_ERROR_OF_MEAN|1.026||0.0128|TWO_SIDED|95.0|-4.57|-0.54|||Mixed Models Analysis|||Month 6 (Statistical analysis 6): Based on MMRM model with factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.54|-4.57|0.0128
71151107|NCT02952820|141794015|SUPERIORITY||LSM Difference|0.205|STANDARD_ERROR_OF_MEAN|0.076||0.0067|TWO_SIDED|95.0|0.057|0.353|||Mixed Models Analysis|||First 7 nights (Statistical analysis): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.353|0.057|0.0067
71151108|NCT02952820|141794015|SUPERIORITY||LSM Difference|0.171|STANDARD_ERROR_OF_MEAN|0.076||0.0237|TWO_SIDED|95.0|0.023|0.32|||Mixed Models Analysis|||First 7 nights (Statistical analysis 2): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.320|0.023|0.0237
71151109|NCT02952820|141794015|SUPERIORITY||LSM Difference|0.077|STANDARD_ERROR_OF_MEAN|0.094||0.412|TWO_SIDED|95.0|-0.107|0.261|||Mixed Models Analysis|||Month 1 (Statistical analysis 3): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.261|-0.107|0.4120
71151110|NCT02952820|141794015|SUPERIORITY||LSM Difference|0.073|STANDARD_ERROR_OF_MEAN|0.094||0.4347|TWO_SIDED|95.0|-0.111|0.258|||Mixed Models Analysis|||Month 1 (Statistical analysis 4): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.258|-0.111|0.4347
71151111|NCT02952820|141794015|SUPERIORITY||LSM Difference|0.074|STANDARD_ERROR_OF_MEAN|0.109||0.4992|TWO_SIDED|95.0|-0.141|0.289|||Mixed Models Analysis|||Month 3 (Statistical analysis 5): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.289|-0.141|0.4992
71151112|NCT02952820|141794015|SUPERIORITY||LSM Difference|0.255|STANDARD_ERROR_OF_MEAN|0.11||0.0208|TWO_SIDED|95.0|0.039|0.471|||Mixed Models Analysis|||Month 3 (Statistical analysis 6): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.471|0.039|0.0208
71151113|NCT02952820|141794015|SUPERIORITY||LSM Difference|0.144|STANDARD_ERROR_OF_MEAN|0.119||0.2248|TWO_SIDED|95.0|-0.089|0.378|||Mixed Models Analysis|||Month 6 (Statistical analysis 7): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.378|-0.089|0.2248
71151114|NCT02952820|141794015|SUPERIORITY||LSM Difference|0.261|STANDARD_ERROR_OF_MEAN|0.12||0.0298|TWO_SIDED|95.0|0.026|0.497|||Mixed Models Analysis|||Month 6 (Statistical analysis 8): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.497|0.026|0.0298
71151115|NCT03486834|141794031|OTHER|The incidence rate per 100 person years (100 x number of CMVi cases/total person-years to CMVi or end of follow-up) is presented along with 95% confidence interval (CI).|Incidence Rate Estimate|2.9|||||TWO_SIDED|95.0|1.6|4.9||||||||4.9|1.6|
71151116|NCT03486834|141794031|OTHER|The incidence rate per 100 person years (100 x number of CMVi cases/total person-years to CMVi or end of follow-up) is presented along with 95% CI.|Incidence Rate Estimate|5.1|||||TWO_SIDED|95.0|3.3|7.6||||||||7.6|3.3|
70876242|NCT02564042|141236518|OTHER||Proportion difference|12.7|||||TWO_SIDED|95.0|-15.1|38.9|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 4 has been presented|||38.9|-15.1|
70876243|NCT02564042|141236518|OTHER||Proportion difference|12.5|||||TWO_SIDED|95.0|-13.6|37.4|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 4 has been presented .|||37.4|-13.6|
70876244|NCT02564042|141236518|OTHER||Proportion difference|42.3|||||TWO_SIDED|95.0|13.8|66.0|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 8 has been presented|||66.0|13.8|
71151117|NCT03486834|141794031|OTHER|The statistical criterion for success requires the lower limit of the 95% CI of vaccine efficacy (VE) to be greater than 0%.|Vaccine Efficacy|42.4|||||TWO_SIDED|95.0|-13.5|71.1||||||||71.1|-13.5|
71151118|NCT03486834|141794032|OTHER||Difference in Percent|59.8|||||TWO_SIDED|95.0|55.8|63.5||||||||63.5|55.8|
71151119|NCT03486834|141794032|OTHER||Difference in Percent|57.6|||||TWO_SIDED|95.0|53.5|61.5||||||||61.5|53.5|
71151120|NCT03486834|141794033|OTHER||Difference in Percent|15.9|||||TWO_SIDED|95.0|11.7|20.1||||||||20.1|11.7|
70876245|NCT02564042|141236518|OTHER||Proportion difference|37.0|||||TWO_SIDED|95.0|8.7|61.3|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 8 has been presented|||61.3|8.7|
71151121|NCT03486834|141794033|OTHER||Difference in Percent|17.4|||||TWO_SIDED|95.0|13.3|21.6||||||||21.6|13.3|
71151122|NCT03486834|141794034|OTHER||Difference in Percent|0.0|||||TWO_SIDED|95.0|-0.5|0.5||||||||0.5|-0.5|
71151123|NCT03486834|141794034|OTHER||Difference in Percent|0.0|||||TWO_SIDED|95.0|-0.5|0.5||||||||0.5|-0.5|
71151124|NCT03486834|141794035|OTHER|The incidence rate per 100 person years (100 x number of CMVi cases/total person-years to CMVi or end of follow-up) is presented along with 95% CI.|Incidence Rate Estimate|6.7|||||TWO_SIDED|95.0|4.6|9.5||||||||9.5|4.6|
71151125|NCT03486834|141794035|OTHER|The incidence rate per 100 person years (100 x number of CMVi cases/total person-years to CMVi or end of follow-up) is presented along with 95% CI.|Incidence Rate Estimate|5.1|||||TWO_SIDED|95.0|3.3|7.6||||||||7.6|3.3|
71151126|NCT03486834|141794035|OTHER|The statistical criterion for success requires the lower limit of the 95% CI of vaccine efficacy (VE) to be greater than 0%.|Vaccine Efficacy|-32.0|||||TWO_SIDED|95.0|-135.0|25.0||||||||25.0|-135.0|
71151127|NCT00638014|141794051|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||t-test, 2 sided|||||||0.41
71151128|NCT01587924|141794056|SUPERIORITY_OR_OTHER|||||||0.0135||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline Hgb \<10.80 versus modeled Hgb change from baseline in participants with Baseline Hgb \>= 10.80||||0.0135
71151129|NCT01587924|141794056|SUPERIORITY_OR_OTHER|||||||0.5082||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline weight \<= 80.5 Kg versus modeled Hgb change from baseline in participants with Baseline weight \> 80.5||||0.5082
71151130|NCT01587924|141794056|SUPERIORITY_OR_OTHER|||||||0.977||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with ethnicity non-Hispanic or Latino versus modeled Hgb change from baseline in participants with ethnicity non-Hispanic or Latino||||0.9770
71151131|NCT01587924|141794056|SUPERIORITY_OR_OTHER|||||||0.0618||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline geographic ancestry as African American versus modeled Hgb change from baseline in participants with no geographic ancestry as African American||||0.0618
71151132|NCT01587924|141794056|SUPERIORITY_OR_OTHER|||||||0.7495||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline gender as male versus modeled Hgb change from baseline in participants with Baseline gender female||||0.7495
71151133|NCT01587924|141794056|SUPERIORITY_OR_OTHER|||||||0.7865||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline age \<65 years versus modeled Hgb change from baseline in participants with Baseline age \>=65 years||||0.7865
71151134|NCT01587924|141794056|SUPERIORITY_OR_OTHER|||||||0.0622||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline co-ad with food versus modeled Hgb change from baseline in participants with Baseline co-ad without food||||0.0622
71151135|NCT01587924|141794056|SUPERIORITY_OR_OTHER|||||||0.2044||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline diabetes presence versus modeled Hgb change from baseline in participants with no Baseline diabetes||||0.2044
71151136|NCT01587924|141794056|SUPERIORITY_OR_OTHER|||||||0.8537||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline region as the US and Canada versus modeled Hgb change from baseline in participants with Baseline region as not the US and Canada||||0.8537
71151137|NCT00357903|141794106|SUPERIORITY_OR_OTHER||Standardized incidence rate|0.0||||||95.0|0.0|53.87||||||||53.87|0.00|
71151138|NCT00357903|141794106|SUPERIORITY_OR_OTHER||Standardized incidence rate|1.3||||||95.0|0.97|1.71||||||||1.71|0.97|
71151139|NCT00606593|141794108|SUPERIORITY_OR_OTHER||Least square means treatment effect|-10.4||||0.0018|TWO_SIDED|95.0|-17.0|-3.9|||Linear model|||||-3.9|-17.0|0.0018
71151140|NCT00606593|141794108|SUPERIORITY_OR_OTHER||Least square means treatment effect|-19.2|||<|0.0001|TWO_SIDED|95.0|-25.7|-12.6|||Linear model|||||-12.6|-25.7|<0.0001
71151141|NCT00606593|141794108|SUPERIORITY_OR_OTHER||Least square means treatment effect|-31.4|||<|0.0001|TWO_SIDED|95.0|-38.0|-24.9|||Linear model|||||-24.9|-38.0|<0.0001
71151142|NCT00606593|141794108|SUPERIORITY_OR_OTHER||Least square means treatment effect|-46.5|||<|0.0001|TWO_SIDED|95.0|-53.3|-39.9|||Linear model|||||-39.9|-53.3|<0.0001
71151143|NCT00606593|141794109|SUPERIORITY_OR_OTHER||Least square means treatment effect|14.3|||<|0.0001|TWO_SIDED|95.0|7.4|21.2|||Linear model|||||21.2|7.4|<0.0001
71151144|NCT00606593|141794109|SUPERIORITY_OR_OTHER||Least square means treatment effect|21.5|||<|0.0001|TWO_SIDED|95.0|14.6|28.4|||Linear model|||||28.4|14.6|<0.0001
71151145|NCT00606593|141794109|SUPERIORITY_OR_OTHER||Least square means treatment effect|34.7|||<|0.0001|TWO_SIDED|95.0|27.8|41.6|||Linear model|||||41.6|27.8|<0.0001
71151146|NCT00606593|141794109|SUPERIORITY_OR_OTHER||Least square means treatment effect|55.1|||<|0.0001|TWO_SIDED|95.0|48.2|62.0|||Linear model|||||62.0|48.2|<0.0001
71151147|NCT06042855|141794127|SUPERIORITY|Posterior probability of efficacy (P(HR\>1))|Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.89|1.03|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.03|0.89|
71151148|NCT06042855|141794128|SUPERIORITY||Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|0.32|6.38||||||No hypothesis test or decision rule was evaluated.||6.38|0.32|
71151149|NCT06042855|141794131|SUPERIORITY||Hazard Ratio (HR)|1.25|||||TWO_SIDED|95.0|0.82|1.78|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.78|0.82|
71151150|NCT06042855|141794132|SUPERIORITY||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.66|1.31|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.31|0.66|
71151151|NCT06042855|141794133|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.57|1.41|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.41|0.57|
71151152|NCT06042855|141794134|SUPERIORITY||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.78|1.42|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.42|0.78|
71151153|NCT06042855|141794142|SUPERIORITY|Posterior probability of efficacy (P(Difference in MTU (Active - Placebo)\<0))|Difference in model estimate time unwell|0.03|||||TWO_SIDED|95.0|-0.21|0.28|||||The mean time unwell is estimated from receipt of study drug to study day 14. The interval is a highest density credible interval.|No hypothesis test or decision rule was evaluated.||0.28|-0.21|
71151154|NCT06042855|141794143|SUPERIORITY|Posterior probability of efficacy (P(Difference days benefit (Active - Placebo)\>0))|Difference in model estimate time unwell|-0.04|||||TWO_SIDED|95.0|-0.34|0.26|||||The interval is a highest density credible interval.|Analysis is exploratory. No hypothesis test or decision rule was evaluated.||0.26|-0.34|
71151155|NCT04546672|141794155|SUPERIORITY||Mean Difference (Final Values)|12.1||||0.58|TWO_SIDED|95.0|-31.1|55.4|||t-test, 2 sided|||||55.4|-31.1|0.58
71151156|NCT04546672|141794156|SUPERIORITY||Mean Difference (Final Values)|12.3|||<|0.001|TWO_SIDED|95.0|9.2|15.4|||t-test, 2 sided|||||15.4|9.2|<0.001
71151157|NCT04546672|141794157|SUPERIORITY||Odds Ratio (OR)|2.3||||0.087|TWO_SIDED|95.0|0.9|6.2|||Fisher Exact|||||6.2|0.9|0.087
71151158|NCT04546672|141794158|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.48|TWO_SIDED|95.0|-26.4|12.6|||t-test, 2 sided|||||12.6|-26.4|0.48
71151159|NCT04546672|141794159|SUPERIORITY||Mean Difference (Final Values)|16.7||||0.02|TWO_SIDED|95.0|2.3|31.1|||t-test, 2 sided|||||31.1|2.3|0.02
71151160|NCT04546672|141794160|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.27|TWO_SIDED|95.0|-2.2|8.3|||t-test, 2 sided|||||8.3|-2.2|0.27
71151161|NCT00525161|141794166|SUPERIORITY_OR_OTHER||Clinical Response Rate at 3 months|0.0|||||TWO_SIDED||||||||Defined as complete response/partial response after 3 months of adding sorafenib to endocrine therapy|Based on known historical response rate to sorafenib of no better than 5-10%, the study was designed to test the null hypothesis that the clinical response rate is no better than 10% versus the alternative hypothesis that it is at least 25% when sorafenib is added to endocrine therapy. In the first stage, 18 patients were planned for enrollment, and if two or fewer responses were observed, the trial would be terminated. The study stopped after 11 due to slow accrual and withdrawal of funding.||||
71151162|NCT00525161|141794167|SUPERIORITY_OR_OTHER||Median Progression Free Survival|6.1|||||TWO_SIDED|95.0|2.6|11.3||||||||11.3|2.6|
71151163|NCT03848728|141794183|SUPERIORITY||Risk Ratio (RR)|1.1||||0.0019|TWO_SIDED|95.0|1.03|1.16|||TMLE|||||1.16|1.03|0.0019
71151164|NCT02581410|141794201|NON_INFERIORITY|Non-inferiority will be demonstrated if the upper limit of the two-sided 95% confidence interval of the adjusted geometric mean concentration (GMC) ratio (No prev- Zvax over Prev-Zvax) 1 month post-dose 2 is below 1.5 in terms of anti-gE antibodies.|Adjusted GMC ratio|1.04|||||TWO_SIDED|95.0|0.92|1.17|||ANCOVA|||To compare humoral immune responses at 1 month after dose 2 of GSK1437173A (Month 3) in subjects ≥ 65 years of age who received Zostavax ≥ 5 years earlier (Prev-Zvax) as compared to subjects who have never received Zostavax (No prev-Zvax).||1.17|0.92|
71151165|NCT02000115|141794235|NON_INFERIORITY|8.0% non-inferiority margin|Difference in percentages between groups|1.5||||0.006|ONE_SIDED|95.0||5.7||p for non-inferiority|Kaplan-Meier estimates|Kaplan-Meier was used as the method for calculating the endpoint rate|Non-inferiority of the Portico valve to commercially available valves was shown if the upper bound of the 95% confidence interval (1-sided) for the difference in event rates between groups was less than the non-inferiority margin (8·0%)|We analysed the primary effectiveness endpoint in the intention-to- treat (ITT) population using the Kaplan-Meier method to estimate event rates, the Greenwood method to calculate the standard error of the Kaplan-Meier estimates, and assuming an asymptotic normal distribution for event rate estimates.||5.7||0.006
71151166|NCT02000115|141794236|NON_INFERIORITY|8.5% non-inferiority margin|Difference in percentages between groups|4.2||||0.03|ONE_SIDED|95.0||8.1||p for non-inferiority|Kaplan-Meier estimates|Kaplan-Meier was used as the method for calculating the endpoint rate|Non-inferiority of the Portico valve to commercially available valves was shown if the upper bound of the 95% confidence interval (1-sided) for the difference in event rates between groups was less than the non-inferiority margin (8·5%)|We analysed the primary safety endpoint in the intention-to-treat (ITT) population using the Kaplan-Meier method to estimate event rates, the Greenwood method to calculate the standard error of the Kaplan-Meier estimates, and assuming an asymptotic normal distribution for event rate estimates.||8.1||0.03
71151167|NCT02000115|141794238|NON_INFERIORITY|non-inferiority margin of 4%|Difference in percentages between groups|0.4||||0.001|ONE_SIDED|95.0||2.3||p for non-inferiority|Farrington-Manning test|The test statistic is based on the Farrington-Manning method of testing non-inferiority of proportions.|If the upper limit of the 95% confidence interval (1-sided) for the difference of proportions (Portico - CAV) is \< 4%, then non inferiority is demonstrated.|||2.3||0.001
70876246|NCT02564042|141236518|OTHER||Proportion difference|33.3|||||TWO_SIDED|95.0|4.8|58.2|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 8 has been presented .|||58.2|4.8|
70876247|NCT02564042|141236518|OTHER||Proportion difference|40.6|||||TWO_SIDED|95.0|12.8|63.9|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 8 has been presented.|||63.9|12.8|
71151168|NCT02000115|141794239|NON_INFERIORITY|non-inferiority margin of 10 points|Mean Difference (Final Values)|-0.5|||<|0.0001|ONE_SIDED|95.0|-3.5|||p for non-inferiority|two-sample t-test|The test statistic is based on two sample t-test|If the lower limit of the 95% confidence interval (1-sided) for the difference of (Portico - CAV) is \> -10, then non inferiority is demonstrated.||||-3.5|<0.0001
71151169|NCT02000115|141794240|NON_INFERIORITY|non-inferiority margin of 6%|Difference in percentages between groups|5.6||||0.4|ONE_SIDED|95.0||8.5||p for non-inferiority|Farrington-Manning test|The test statistic is based on the Farrington-Manning method of testing non-inferiority of proportions|If the upper limit of the 95% confidence interval (1-sided) for the difference of proportions (Portico - CAV) is \< 6%, then non inferiority is demonstrated.|||8.5||0.40
71151170|NCT02000115|141794241|NON_INFERIORITY|non-inferiority margin on -36 meters|Mean Difference (Final Values)|3.5||||0.0003|ONE_SIDED|95.0|-15.4|||p for non-inferiority|two sample t-test|The test statistic is based on a two-sample t-test|If the lower limit of the 95% confidence interval (1-sided) for the difference of (Portico - CAV) is \> -36, then non inferiority is demonstrated.||||-15.4|0.0003
71151171|NCT04145349|141794270|SUPERIORITY||Posterior Mean Hazard Ratio|0.69|||||TWO_SIDED|98.0|0.25|1.69|||Bayesian hierarchical model|||The Bayesian analyses below include posterior mean of Hazard ratio, and credible intervals instead of confidence intervals.|The posterior probability treatment difference is 0.864|1.69|0.25|
71151172|NCT01148979|141794277|OTHER|A Paired sample t-test was used to test the null hypothesis of no difference in MDAR score change after 4 weeks of treatment with Vyvanse versus placebo.|||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||The statistical analysis represents a within-subject comparison of change under treatment with Vyvanse versus change under treatment with placebo, using paired t-tests with each subject as their own control. All tests reported are two-tailed.||||<0.05
70876248|NCT02564042|141236518|OTHER||Proportion difference|54.7|||||TWO_SIDED|95.0|25.9|76.6|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 12 has been presented.|||76.6|25.9|
70876249|NCT02564042|141236518|OTHER||Proportion difference|51.0|||||TWO_SIDED|95.0|22.2|73.2|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 12 has been presented|||73.2|22.2|
70876250|NCT02564042|141236518|OTHER||Proportion difference|35.6|||||TWO_SIDED|95.0|6.3|60.5|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 12 has been presented|||60.5|6.3|
70876251|NCT02564042|141236518|OTHER||Proportion difference|30.7|||||TWO_SIDED|95.0|1.6|55.9|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 12 has been presented|||55.9|1.6|
70876252|NCT02564042|141236518|OTHER||Proportion difference|51.3|||||TWO_SIDED|95.0|22.0|74.0|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 14 has been presented|||74.0|22.0|
70876253|NCT02564042|141236518|OTHER||Proportion difference|61.5|||||TWO_SIDED|95.0|34.6|81.0|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 14 has been presented|||81.0|34.6|
70876254|NCT02564042|141236518|OTHER||Proportion difference|23.9|||||TWO_SIDED|95.0|-6.1|51.0|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 14 has been presented|||51.0|-6.1|
70876255|NCT02564042|141236518|OTHER||Proportion difference|37.0|||||TWO_SIDED|95.0|7.8|61.6|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 14 has been presented|||61.6|7.8|
70876256|NCT02564042|141236518|OTHER||Proportion difference|53.1|||||TWO_SIDED|95.0|24.7|75.6|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 16 has been presented|||75.6|24.7|
70876257|NCT02564042|141236518|OTHER||Proportion difference|53.8|||||TWO_SIDED|95.0|25.8|75.5|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 16 has been presented|||75.5|25.8|
70956650|NCT01871805|141416696|SUPERIORITY|||||||0.001||||||Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.|Exact Clopper-Pearson CI, 2 sided|||||||0.0010
70956651|NCT03412747|141416722|NON_INFERIORITY|The evaluation of non-inferiority is tested at a 1-sided alpha level of 0.025 and based on a 1-sided 97.5% CI and a non-inferiority margin of 10%.|Risk Difference (RD)|39.3|||||TWO_SIDED|95.0|30.9|47.7||||||Risk Difference: BKZ-ADA calculated using stratified CMH.||47.7|30.9|
70956652|NCT03412747|141416722|SUPERIORITY||Odds Ratio (OR)|7.459|||<|0.001|TWO_SIDED|95.0|4.709|11.816||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||11.816|4.709|<0.001
70956653|NCT03412747|141416723|NON_INFERIORITY|The evaluation of non-inferiority is tested at a 1-sided alpha level of 0.025 and based on a 1-sided 97.5% CI and a non-inferiority margin of 10%.|Risk Difference (RD)|28.2|||||TWO_SIDED|95.0|19.7|36.7||||||Risk Difference: BKZ-ADA calculated using stratified CMH.||36.7|19.7|
70956654|NCT03412747|141416723|SUPERIORITY||Odds Ratio (OR)|4.341|||<|0.001|TWO_SIDED|95.0|2.785|6.765||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||6.765|2.785|<0.001
70956655|NCT03412747|141416724|SUPERIORITY||Odds Ratio (OR)|6.231|||<|0.001|TWO_SIDED|95.0|3.515|11.046||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||11.046|3.515|<0.001
70956656|NCT03412747|141416724|SUPERIORITY||Odds Ratio (OR)|5.75|||<|0.001|TWO_SIDED|95.0|3.657|9.041||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||9.041|3.657|<0.001
71151173|NCT01383356|141794307|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|Geometric mean ratio (GMR) in percent|118.0|||||TWO_SIDED|90.0|111.0|125.0|||||Lina/Met 2.5mg/500mg versus (vs.) Lina 2.5mg plus Met 500mg.|The two formulations are shown to be bioequivalent if the geometric mean ratio is contained within the 80 to 125 percent range both on measured data (statistical analysis 1) and on potency corrected data (percent potency of label claim) (statistical analysis 2). ANOVA was applied to log-transformed Cmax and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction.||125|111|
70956657|NCT03412747|141416725|SUPERIORITY||Odds Ratio (OR)|4.724|||<|0.001|TWO_SIDED|95.0|2.683|8.318||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||8.318|2.683|<0.001
70956658|NCT03412747|141416725|SUPERIORITY||Odds Ratio (OR)|4.762|||<|0.001|TWO_SIDED|95.0|3.014|7.523||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||7.523|3.014|<0.001
70956659|NCT03412747|141416726|SUPERIORITY||Odds Ratio (OR)|7.103|||<|0.001|TWO_SIDED|95.0|4.637|10.88||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||10.880|4.637|<0.001
70956660|NCT03412747|141416727|SUPERIORITY||Odds Ratio (OR)|4.974|||<|0.001|TWO_SIDED|95.0|3.23|7.661||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||7.661|3.230|<0.001
70956661|NCT03412747|141416728|SUPERIORITY||Odds Ratio (OR)|5.249|||<|0.001|TWO_SIDED|95.0|3.207|8.593||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||8.593|3.207|<0.001
70956662|NCT03412747|141416728|SUPERIORITY||Odds Ratio (OR)|4.974|||<|0.001|TWO_SIDED|95.0|3.257|7.594||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||7.594|3.257|<0.001
70956663|NCT00468104|141416738|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||A univariate analysis was done to identify possible predictors of successful resolution of symptoms. The chi-square analysis was used to compare the percent successful.||||<0.001
70956664|NCT00141219|141416743|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.115||||0.289||95.0|0.785|1.583||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Cochran-Mantel-Haenszel|P-value in above table was from Cochran-Mantel-Haenszel test comparing Pregabalin and Placebo adjusted for center.|RR estimates relative responder rate between Pregabalin and Placebo (the ratio of the former responder rate to the latter). Estimated RR was center-adjusted ie, assumed common RR in all centers, then a weighted average of center specific RRs computed|Null hypothesis of no treatment difference in each of the centers.||1.583|0.785|0.289
71151174|NCT01383356|141794307|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|GMR, potency corrected (percent)|122.0|||||TWO_SIDED|90.0|114.0|130.0|||||Lina/Met 2.5mg/500mg vs. Lina 2.5mg plus Met 500mg.|ANOVA was applied to log-transformed Cmax and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction. Results were potency corrected (GMR multiplied by the quotient of drug potency (DP) of Met in single tablet and DP of Met in combination tablet).||130|114|
70876258|NCT02564042|141236518|OTHER||Proportion difference|29.4|||||TWO_SIDED|95.0|-0.3|55.0|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 16 has been presented|||55.0|-0.3|
70876259|NCT02564042|141236518|OTHER||Proportion difference|35.7|||||TWO_SIDED|95.0|6.5|60.2|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 16 has been presented|||60.2|6.5|
70876260|NCT02564042|141236518|OTHER||Proportion difference|10.0|||||TWO_SIDED|95.0|-36.9|53.9|||||Difference between GSK2894512 1% BID and Vehicle BID at EW has been presented|||53.9|-36.9|
70876261|NCT02564042|141236518|OTHER||Proportion difference|42.9|||||TWO_SIDED|95.0|-6.3|81.6|||||Difference between GSK2894512 1% QD and Vehicle QD at EW has been presented|||81.6|-6.3|
70876262|NCT02564042|141236518|OTHER||Proportion difference|25.0|||||TWO_SIDED|95.0|-35.7|80.6|||||Difference between GSK2894512 0.5% BID and Vehicle BID at EW has been presented|||80.6|-35.7|
70876263|NCT00303498|141236552|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|43.0||||0.0302|||||||ANCOVA|Change at Week 24: P-value was obtained from the non-parametric analysis of covariance (ANCOVA) controlling for baseline treadmill exercise time.||The median of the treatment difference was calculated using the Hodges-Lehmann estimator.||||0.0302
70876264|NCT00303498|141236553|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.5||||0.495|||||||ANCOVA|Change at Week 24: P-value was calculated from an ANCOVA with effect for treatment and baseline value as a covariate.||||||0.4950
70876265|NCT00303498|141236554|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.6||||0.3874|||||||ANCOVA|P-value was calculated from an ANCOVA with effect for treatment and baseline value as a covariate.||Change at Week 24 for PLAX 2D mode||||0.3874
70876266|NCT00303498|141236554|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.8||||0.7038|||||||ANCOVA|P-value was calculated from an ANCOVA with effect for treatment and baseline value as a covariate.||Change at Week 24 for PSAX M-mode||||0.7038
70876267|NCT00303498|141236555|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.9||||0.8998|||||||ANCOVA|P-value was calculated from an ANCOVA with effect for treatment and baseline value as a covariate.||||||0.8998
70876268|NCT00303498|141236556|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.7||||0.7245|||||||ANCOVA|P-value was calculated from an ANCOVA with effect for treatment and baseline value as a covariate.||||||0.7245
70876269|NCT00303498|141236557|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.5||||0.8649|||||||ANCOVA|P-value was calculated from an ANCOVA with effect for treatment and baseline value as a covariate.||||||0.8649
70876270|NCT00303498|141236558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5909||||||The statistical analysis (P value) was performed on the composite change for all categories.|Cochran-Mantel-Haenszel|||Change at Week 24||||0.5909
70876271|NCT01988103|141236566|SUPERIORITY_OR_OTHER_LEGACY||Difference|16.4||||0.0032|TWO_SIDED|95.0|5.8|27.0|||Chi-squared|||||27.0|5.8|0.0032
70876272|NCT01988103|141236566|SUPERIORITY_OR_OTHER_LEGACY||Difference|21.1||||0.0003|TWO_SIDED|95.0|10.1|32.1|||Chi-squared|||||32.1|10.1|0.0003
70876273|NCT01988103|141236567|SUPERIORITY_OR_OTHER_LEGACY||Difference|15.1||||0.0165|TWO_SIDED|95.0|3.1|27.1|||Chi-squared|||||27.1|3.1|0.0165
70876274|NCT01988103|141236567|SUPERIORITY_OR_OTHER_LEGACY||Difference|20.8||||0.002|TWO_SIDED|95.0|8.2|33.3|||Chi-squared||Missing values were imputed using the LOCF method.|||33.3|8.2|0.0020
70876275|NCT01988103|141236568|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-29.1||||0.0003|TWO_SIDED|95.0|-44.5|-13.6|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-13.6|-44.5|0.0003
70876276|NCT01988103|141236568|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.0|||<|0.0001|TWO_SIDED|95.0|-53.4|-22.6|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-22.6|-53.4|<0.0001
70876277|NCT01988103|141236569|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-29.5||||0.0002|TWO_SIDED|95.0|-44.9|-14.0|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-14.0|-44.9|0.0002
70876278|NCT01988103|141236569|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-39.5|||<|0.0001|TWO_SIDED|95.0|-54.9|-24.1|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-24.1|-54.9|<0.0001
70876279|NCT01988103|141236570|SUPERIORITY_OR_OTHER_LEGACY||Difference|19.7||||0.0057|TWO_SIDED|95.0|6.1|33.4|||Chi-squared|||||33.4|6.1|0.0057
70876280|NCT01988103|141236570|SUPERIORITY_OR_OTHER_LEGACY||Difference|29.2|||<|0.0001|TWO_SIDED|95.0|15.4|42.9|||Chi-squared|||||42.9|15.4|<0.0001
70876281|NCT01988103|141236571|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.6||||0.0003|TWO_SIDED|95.0|-22.6|-6.7|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-6.7|-22.6|0.0003
70956665|NCT00141219|141416744|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.644||||0.041||95.0|0.915|2.954||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Cochran-Mantel-Haenszel|P-value in above table was from Cochran-Mantel-Haenszel test comparing Pregabalin and Placebo adjusted for center.|RR estimates relative responder rate between Pregabalin and Placebo (the ratio of the former responder rate to the latter). Estimated RR was center-adjusted ie, assumed common RR in all centers, then a weighted average of center specific RRs computed|Null hypothesis of no treatment difference in each of the centers.||2.954|0.915|0.041
70876282|NCT01988103|141236571|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-24.8|||<|0.0001|TWO_SIDED|95.0|-32.7|-16.9|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate. Missing values were imputed using the LOCF method.|||-16.9|-32.7|<0.0001
70956666|NCT00141219|141416745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.252||0.049||95.0|-1.0|0.0||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from the general linear model with treatment and center fitted as factors and the baseline value as a covariate.||Null hypotheses stated there was no difference in pregabalin and placebo in the primary endpoint versus the alternative that there was. The target sample size was 234 subjects (156 and 78 respectively pregabalin vs placebo using a 2:1 ratio). The calculations assumed a 2-sided comparison at 0.05 alpha, 80% power and 3% dropout. Also, a treatment difference of 1 point and a standard deviation for endpoint mean pain scores of 2.5 were assumed based on previous studies.||-0.00|-1.00|0.049
70956667|NCT00141219|141416745|SUPERIORITY_OR_OTHER_LEGACY|||||||0.729||95.0||||Interaction p-value based on adding interaction term to the main model.|General Linear Model|"In supportive model 1, a treatment by center independent variable added to the main model."||This was a supportive analysis of the primary endpoint to determine if the main results were generalizable across centers.||||0.729
70956668|NCT00141219|141416745|SUPERIORITY_OR_OTHER_LEGACY|||||||0.979||95.0||||Interaction p-value based on adding interaction term to the main model.|General Linear Model|"In supportive model 2, a treatment by baseline mean pain independent variable added to the main model."||This was a supportive analysis of the primary endpoint to determine if the main results were generalizable across different baseline values.||||0.979
70956669|NCT00141219|141416746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.267||0.077||95.0|-1.0|0.05||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center fitted as factors and the baseline value as a covariate.||"Endpoint Mean Pain Score~Pregabalin minus Placebo"||0.05|-1.00|0.077
70956670|NCT00141219|141416747|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.186||0.042||95.0|-0.75|-0.01||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center, and treatment by week interaction as factors and baseline value as a covariate.||"Mean Pain Score Weeks 1 to 8~Overall Comparison (8-week average)~Pregabalin minus Placebo"||-0.01|-0.75|0.042
70956671|NCT00141219|141416747|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.21||0.071||95.0|-0.79|0.03||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 1 Mean Pain Score~Pregabalin minus Placebo"||0.03|-0.79|0.071
70956672|NCT00141219|141416747|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.212||0.149||95.0|-0.72|0.11||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 2 Mean Pain Score~Pregabalin minus Placebo"||0.11|-0.72|0.149
70956673|NCT00141219|141416747|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.213||0.057||95.0|-0.82|0.01||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 3 Mean Pain Score~Pregabalin minus Placebo"||0.01|-0.82|0.057
70956674|NCT00141219|141416747|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.215||0.044||95.0|-0.85|-0.01||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 4 Mean Pain Score~Pregabalin minus Placebo"||-0.01|-0.85|0.044
70956675|NCT00141219|141416747|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.216||0.051||95.0|-0.85|0.0||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 5 Mean Pain Score~Pregabalin minus Placebo"||0.00|-0.85|0.051
70876283|NCT01988103|141236572|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.7||||0.0204|TWO_SIDED|95.0|-3.2|-0.3|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-0.3|-3.2|0.0204
70956676|NCT00141219|141416747|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.216||0.178||95.0|-0.72|0.13||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 6 Mean Pain Score~Pregabalin minus Placebo"||0.13|-0.72|0.178
70956677|NCT00141219|141416747|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.218||0.104||95.0|-0.78|0.07||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 7 Mean Pain Score~Pregabalin minus Placebo"||0.07|-0.78|0.104
70956678|NCT00141219|141416747|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.218||0.039||95.0|-0.88|-0.02||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 8 Mean Pain Score~Pregabalin minus Placebo"||-0.02|-0.88|0.039
70956679|NCT00141219|141416748|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.186||0.044||95.0|-0.74|-0.01||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Duration Adjusted Average Change (DAAC)~Pregabalin minus Placebo"||-0.01|-0.74|0.044
70876284|NCT01988103|141236572|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.5|||<|0.0001|TWO_SIDED|95.0|-4.9|-2.0|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-2.0|-4.9|<0.0001
70956680|NCT00141219|141416749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.272||0.018||95.0|-1.19|-0.11||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Endpoint Sleep Interference Score~Pregabalin minus Placebo"||-0.11|-1.19|0.018
71151175|NCT01383356|141794308|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|Geometric mean ratio (percent)|105.0||||||90.0|101.0|108.0|||||Lina/Met 2.5mg/500mg vs. Lina 2.5mg plus Met 500mg.|The two formulations are shown to be bioequivalent if the 90 percent confidence interval of geometric mean ratio is entirely contained within the 80 to125 percent range both on measured data (statistical analysis 1) and potency corrected data (percent potency of label claim) (statistical analysis 2). ANOVA was applied to log-transformed AUC0-t and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction.||108|101|
71151176|NCT01383356|141794308|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|GMR, potency corrected (percent)|108.0||||||90.0|105.0|112.0|||||Lina/Met 2.5mg/500mg vs.Lina 2.5mg plus Met 500mg.|ANOVA was applied to log-transformed AUC0-t and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction. Results were potency corrected (GMR multiplied by the quotient of DP of Met in single tablet and DP of Met in combination tablet).||112|105|
71151177|NCT01383356|141794309|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE), AUC0-inf was no BE criteria|Geometric mean ratio (percent)|105.0||||||90.0|101.0|108.0|||||Lina/Met 2.5mg/500mg vs. Lina 2.5mg plus Met 500mg.|ANOVA was applied to log-transformed AUC0-inf and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction.||108|101|
71151178|NCT01383356|141794309|NON_INFERIORITY_OR_EQUIVALENCE|BE, AUC0-inf was no BE criteria|GMR, potency corrected (percent)|108.0||||||90.0|105.0|112.0|||||Lina/Met 2.5mg/500mg vs. Lina 2.5mg plus Met 500mg.|ANOVA was applied to log-transformed AUC0-inf and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction. Results were potency corrected (GMR multiplied by the quotient of DP of Met in single tablet and DP of Met in combination tablet).||112|105|
71151179|NCT00602472|141794328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|-0.73|-0.5|||ANCOVA|||Linagliptin vs. Placebo||-0.50|-0.73|<0.0001
71151180|NCT00602472|141794329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|-0.56|-0.41|||ANCOVA|||Linagliptin vs. Placebo||-0.41|-0.56|<0.0001
71151181|NCT00602472|141794330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.78|-0.58|||ANCOVA|||Linagliptin vs. Placebo||-0.58|-0.78|<0.0001
71151182|NCT00602472|141794331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.8|-0.59|||ANCOVA|||Linagliptin vs. Placebo||-0.59|-0.80|<0.0001
71151183|NCT00602472|141794332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.7|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001||95.0|-18.1|-7.3|||ANCOVA|||Linagliptin vs. Placebo||-7.3|-18.1|<0.0001
71151184|NCT00602472|141794333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.8|STANDARD_ERROR_OF_MEAN|2.3|<|0.0001||95.0|-22.4|-13.2|||ANCOVA|||Linagliptin vs. Placebo||-13.2|-22.4|<0.0001
71151185|NCT00602472|141794334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.7|STANDARD_ERROR_OF_MEAN|2.4|<|0.0001||95.0|-20.3|-11.1|||ANCOVA|||Linagliptin vs. Placebo||-11.1|-20.3|<0.0001
71151186|NCT00602472|141794335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.1|STANDARD_ERROR_OF_MEAN|2.6|<|0.0001||95.0|-17.2|-7.1|||ANCOVA|||Linagliptin vs. Placebo||-7.1|-17.2|<0.0001
71151187|NCT00602472|141794336|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.51|||<|0.0001||95.0|3.332|9.111|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."||9.111|3.332|<0.0001
71151188|NCT00602472|141794338|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.818|||<|0.0001||95.0|1.989|7.327|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."||7.327|1.989|<0.0001
71151189|NCT00602472|141794340|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.36|||<|0.0001||95.0|2.474|4.562|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."||4.562|2.474|<0.0001
71151190|NCT03038880|141794341|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|-2.1|||||TWO_SIDED|80.0|-6.8|2.6|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|||2.6|-6.8|
71151191|NCT03038880|141794341|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|1.1|||||TWO_SIDED|80.0|-3.4|5.5|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|||5.5|-3.4|
71151192|NCT03038880|141794342|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|-2.09|||||TWO_SIDED|80.0|-6.75|2.56|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||2.56|-6.75|
71151193|NCT03038880|141794342|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|1.05|||||TWO_SIDED|80.0|-3.4|5.49|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||5.49|-3.40|
71151194|NCT03038880|141794342|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|0.49|||||TWO_SIDED|80.0|-4.26|5.25|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||5.25|-4.26|
71151195|NCT03038880|141794342|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|1.83|||||TWO_SIDED|80.0|-2.71|6.37|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||6.37|-2.71|
71151196|NCT03038880|141794344|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|4.76|||||TWO_SIDED|80.0|-15.92|25.44|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||25.44|-15.92|
70876285|NCT01988103|141236573|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.88||||0.5149|TWO_SIDED|95.0|-1.78|3.53|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||3.53|-1.78|0.5149
70876286|NCT01988103|141236573|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.85||||0.1693|TWO_SIDED|95.0|-0.79|4.5|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||4.50|-0.79|0.1693
70876287|NCT03590041|141236579|SUPERIORITY|||||||0.04||||||Linear Mixed Model adjusted for a priori patient covariates: Race/Ethnicity, Gender, Health Literacy, Food Availability, Charlson Score, Mental Illness, Substance use. Adjusted P-value represents the significance test for the time x group interaction|Mixed Models Analysis|||We hypothesized that patients in Patient-Driven SMAs would have greater reductions in Diabetes Distress than those in Standardized SMAs. We expected seeing an effect size of a .6 unit decrease (.30) in Standardized SMAs and 1.2 unit decrease (.60) in Patient-Driven SMAs. We estimate we have \>80% power to detect effect sizes between .29 (ICC=3%) and .34 (ICC=5%).||||0.04
70876288|NCT03590041|141236580|SUPERIORITY|||||||0.82||||||Linear Mixed Model adjusted for a priori patient covariates: Race/Ethnicity, Gender, Health Literacy, Food Availability, Charlson Score, Mental Illness, Substance use. Adjusted P-value represents the significance test for the time x group interaction|Mixed Models Analysis|||We hypothesized that patients in the Patient-Driven condition would have a greater reduction in HbA1c than patients in the Standardized condition. We estimate we have \>80% power to detect effect sizes between .29 (ICC=3%) and .34 (ICC=5%).||||0.82
70876289|NCT02289898|141236582|SUPERIORITY||Hazard Ratio (HR)|0.93|||=|0.7158|TWO_SIDED|95.0|0.63|1.375|||Wilcoxon (Mann-Whitney)|||Efficacy (investigator-assessed Kaplan-Meier estimates of progression-free survival) of placebo/placebo arm to the pooled demcizumab arm (i.e., placebo/placebo arm to demcizumab/placebo and demcizumab/demcizumab arms) in subjects with first-line metastatic pancreatic ductal adenocarcinoma.||1.375|0.630|=0.7158
70876290|NCT01493570|141236583|OTHER||Ratio CSF to Plasma in %|28.31||||1|TWO_SIDED|90.0|25.418|31.532||p-value for ratio outside interval 80% - 125%|ANOVA||Intra Individual geometric coefficient of variation (gCV \[%\]) = 17.50 .|Dose-adjusted CSF to plasma ratio for Cmax. The Analysis of Variance (ANOVA) model was used with 'subject nested within treatment' considered as random effect.||31.532|25.418|1.0000
70876291|NCT02598076|141236597|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|||||||0.015
70876292|NCT02598076|141236598|SUPERIORITY|||||||0.034|||||||t-test, 2 sided|||||||0.034
70876293|NCT02598076|141236599|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||||||0.23
70876294|NCT02598076|141236600|SUPERIORITY|||||||0.095|||||||Fisher Exact|||||||0.095
70876295|NCT02598076|141236601|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||0.047
70876296|NCT00558025|141236612|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin: -15 %, power: 80%|Risk Difference (RD)|-10.75||||||95.0|-20.51|1.48|||Wilson score interval|||Successfully switched patients||1.48|-20.51|
70876297|NCT00558025|141236612|SUPERIORITY_OR_OTHER|||||||0.0803||95.0|||||Cochran-Mantel-Haenszel|test with stratification by country||||||0.0803
70876298|NCT00558025|141236613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.2061||95.0|-2.8|0.6|||ANCOVA|ANCOVA with factors of treatment, country and baseline as covariate||||0.6|-2.8|0.2061
70876299|NCT00558025|141236614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.4694||95.0|-0.8|0.4|||ANCOVA|ANCOVA with factors of treatment, country and baseline as covariate||||0.4|-0.8|0.4694
70876300|NCT00558025|141236615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.1804||95.0|-2.3|0.4|||ANCOVA|ANCOVA with factors of treatment, country and baseline as covariate||||0.4|-2.3|0.1804
70876301|NCT00558025|141236616|SUPERIORITY_OR_OTHER|||||||0.1623|||||||Cochran-Mantel-Haenszel|test with stratification by country||||||0.1623
70876302|NCT00558025|141236617|SUPERIORITY_OR_OTHER|||||||0.1299|||||||Cochran-Mantel-Haenszel|test with stratification by country||||||0.1299
70876303|NCT00558025|141236618|SUPERIORITY_OR_OTHER|||||||0.619||95.0|||||Cochran-Mantel-Haenszel|test with stratification by country||||||0.6190
70876304|NCT03315208|141236621|SUPERIORITY||Chi-squared statistic value|0.23||||0.63|TWO_SIDED||||||Chi-squared, Corrected|df=1||||||0.63
70876305|NCT03315208|141236622|SUPERIORITY||Slope|0.72||||0.29|TWO_SIDED|||||p-value is for the model parameter of the condition-by-time interaction term.|Mixed Models Analysis||The treatment condition effect was determined by the model parameter of the condition-by-time interaction term.|Linear mixed effects models with random intercepts (as best practice likelihood ratio tests dropping random slopes and intercepts indicated that only random intercepts should be retained) were used, with restricted maximum likelihood estimation (REML) for missing data. Analyses were intent-to-treat so included all randomized participants (n=29 in the UP+TAU group and n=18 in the TAU alone group), regardless of whether or not they completed the mid- or post-treatment assessments.||||0.29
70876306|NCT03315208|141236623|SUPERIORITY||Slope|-0.56||||0.5|TWO_SIDED|||||p-value is for the model parameter of the condition-by-time interaction term.|Mixed Models Analysis||The treatment condition effect was determined by the model parameter of the condition-by-time interaction term.|Linear mixed effects models with random intercepts (as best practice likelihood ratio tests dropping random slopes and intercepts indicated that only random intercepts should be retained) were used, with restricted maximum likelihood estimation (REML) for missing data. Analyses were intent-to-treat so included all randomized participants (n=29 in the UP+TAU group and n=18 in the TAU alone group), regardless of whether or not they completed the mid- or post-treatment assessments.||||.50
70876307|NCT03315208|141236624|SUPERIORITY||Slope|-1.96||||0.45|TWO_SIDED|||||p-value is for the model parameter of the condition-by-time interaction term.|Mixed Models Analysis||The treatment condition effect was determined by the model parameter of the condition-by-time interaction term. BSI scores were binarized (0 and \>=1) for this analysis due to the non-normal distribution of this outcome.|Linear mixed effects models with random intercepts (as best practice likelihood ratio tests dropping random slopes and intercepts indicated that only random intercepts should be retained) were used, with restricted maximum likelihood estimation (REML) for missing data. Analyses were intent-to-treat so included all randomized participants (n=29 in the UP+TAU group and n=18 in the TAU alone group), regardless of whether or not they completed the mid- or post-treatment assessments.||||0.45
70876308|NCT03315208|141236626|SUPERIORITY||Slope|-0.19||||0.76|TWO_SIDED|||||p-value is for the model parameter of the condition-by-time interaction term.|Mixed Models Analysis||The treatment condition effect was determined by the model parameter of the condition-by-time interaction term.|Linear mixed effects models with random intercepts (as best practice likelihood ratio tests dropping random slopes and intercepts indicated that only random intercepts should be retained) were used, with restricted maximum likelihood estimation (REML) for missing data. Analyses were intent-to-treat so included all randomized participants (n=29 in the UP+TAU group and n=18 in the TAU alone group), regardless of whether or not they completed the mid- or post-treatment assessments.||||0.76
70876309|NCT03315208|141236627|SUPERIORITY||Slope|-1.07||||0.21|TWO_SIDED|||||p-value is for the model parameter of the condition-by-time interaction term.|Mixed Models Analysis||The treatment condition effect was determined by the model parameter of the condition-by-time interaction term. Due to the non-normal distribution of the Craving Scale, scores on this measure were binarized (\< 15 and \>= 15) for this analysis.|Linear mixed effects models with random intercepts (as best practice likelihood ratio tests dropping random slopes and intercepts indicated that only random intercepts should be retained) were used, with restricted maximum likelihood estimation (REML) for missing data. Analyses were intent-to-treat so included all randomized participants (n=29 in the UP+TAU group and n=18 in the TAU alone group), regardless of whether or not they completed the mid- or post-treatment assessments.||||.21
70876310|NCT03315208|141236628|SUPERIORITY||t statistic|0.29||||0.77|TWO_SIDED||||||t-test, 2 sided|||Due to the non-normal distribution of the PDA variable, this variable was treated as binary (\<50% and \>=50%) for mixed models; however, due to the small numbers of participants (\< 5) in certain cells of treatment condition (UP versus TAU) by time point, we ran into issues with convergence of linear mixed models. Thus, here we report the results from an independent samples t-test of means (percentage of past 30 days abstinent) at post-treatment (UP versus TAU).||||0.77
70876311|NCT00982592|141236632|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.874|TWO_SIDED|95.0|0.7|1.54|||Log Rank|||||1.54|0.70|0.874
70876312|NCT00982592|141236634|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.253|TWO_SIDED|95.0|0.83|2.05|||Log Rank|||||2.05|0.83|0.253
70876313|NCT00333866|141236650|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) mean difference|-0.23||||0.2361|TWO_SIDED|95.0|-0.61|0.15|||ANCOVA|Hochberg's approach was used to protect the Type I error rate at 0.05 level, Hochberg adjusted p-values were presented.||P value was calculated using Analysis of Covariance (ANCOVA) with treatment and center in the model, and the baseline mean pain score as covariate.||0.15|-0.61|0.2361
70876314|NCT00333866|141236650|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56||||0.0132|TWO_SIDED|95.0|-0.94|-0.17|||ANCOVA|Hochberg's approach was used to protect the Type I error rate at 0.05 level, Hochberg adjusted p-values were presented.||P value was calculated using ANCOVA with treatment and center in the model, and the baseline mean pain score as covariate.||-0.17|-0.94|0.0132
70876315|NCT00333866|141236650|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) mean difference|-0.33||||0.1694|TWO_SIDED|95.0|-0.72|0.05|||ANCOVA|Hochberg's approach was used to protect the Type I error rate at 0.05 level, Hochberg adjusted p-values were presented.||P value was calculated using ANCOVA with treatment and center in the model, and the baseline mean pain score as covariate.||0.05|-0.72|0.1694
70876316|NCT00333866|141236651|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0227||95.0|||||Cochran-Mantel-Haenszel|||P-values less than 0.05 (2-sided) considered statistically significant. P-values were calculated using a modified ridit transformation with the Cochran-Mantel-Haenszel procedure, adjusting for center.||||0.0227
70876317|NCT00333866|141236651|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017||95.0|||||Cochran-Mantel-Haenszel|||P-values less than 0.05 (2-sided) considered statistically significant. P-values were calculated using a modified ridit transformation with the Cochran-Mantel-Haenszel procedure, adjusting for center.||||0.0017
70876318|NCT00333866|141236651|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0768||95.0|||||Cochran-Mantel-Haenszel|||P-values less than 0.05 (2-sided) considered statistically significant. P-values were calculated using a modified ridit transformation with the Cochran-Mantel-Haenszel procedure, adjusting for center.||||0.0768
70876319|NCT00333866|141236652|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.01|||<|0.0001|TWO_SIDED|95.0|-1.42|-0.6|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline mean sleep score as covariate.||-0.60|-1.42|<.0001
70876320|NCT00333866|141236652|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.78||||0.0002|TWO_SIDED|95.0|-1.2|-0.37|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline mean sleep score as covariate.||-0.37|-1.20|0.0002
70876321|NCT00333866|141236652|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.48||||0.0222|TWO_SIDED|95.0|-0.89|-0.07|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline mean sleep score as covariate.||-0.07|-0.89|0.0222
70876322|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.85|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 1: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.2|<.0001
70876323|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.7||||0.0003|TWO_SIDED|95.0|-1.1|-0.3|||Mixed Model Repeated Measures ANCOVA|||Week 1: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.3|-1.1|0.0003
70876324|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.81|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 1: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.2|<.0001
70876325|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.97|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.6|||Mixed Model Repeated Measures ANCOVA|||Week 2: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.6|-1.3|<.0001
70956681|NCT00141219|141416750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.226||0.024||95.0|-0.96|-0.07||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Weeks 1 to 8 Mean Sleep Score~Overall Comparison (8-week average)~Pregabalin minus Placebo"||-0.07|-0.96|0.024
71151197|NCT03038880|141794344|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|5.95|||||TWO_SIDED|80.0|-13.62|25.53|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||25.53|-13.62|
71151198|NCT03038880|141794344|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|-4.17|||||TWO_SIDED|80.0|-24.52|16.19|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||16.19|-24.52|
71151199|NCT03038880|141794344|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|8.93|||||TWO_SIDED|80.0|-10.73|28.59|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||28.59|-10.73|
71151200|NCT03038880|141794346|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|-4.76|||||TWO_SIDED|80.0|-10.72|1.19|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||1.19|-10.72|
71151201|NCT03038880|141794346|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|-3.57|||||TWO_SIDED|80.0|-8.07|0.92|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||0.92|-8.07|
71151202|NCT03038880|141794346|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|0.0|||||||||||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||||
71151203|NCT03038880|141794346|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|-3.57|||||TWO_SIDED|80.0|-8.07|0.92|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||0.92|-8.07|
71151204|NCT03038880|141794347|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|21.9|||||TWO_SIDED|80.0|0.76|43.05|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||43.05|0.76|
71151205|NCT03038880|141794347|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|38.57|||||TWO_SIDED|80.0|19.56|57.59|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||57.59|19.56|
71151206|NCT03038880|141794347|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|19.64|||||TWO_SIDED|80.0|-1.14|40.43|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||40.43|-1.14|
71151207|NCT03038880|141794347|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|33.93|||||TWO_SIDED|80.0|14.95|52.91|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||52.91|14.95|
71151208|NCT03038880|141794348|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|0.0|||||||||||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||||
71151209|NCT03038880|141794348|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|3.57|||||TWO_SIDED|80.0|-0.92|8.07|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||8.07|-0.92|
70876326|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.81|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 2: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.2|<.0001
70876327|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.86|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 2: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.2|<.0001
70876328|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.8|||Mixed Model Repeated Measures ANCOVA|||Week 3: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.8|-1.5|<.0001
70876329|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 3: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.2|<.0001
70876330|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.67||||0.0005|TWO_SIDED|95.0|-1.0|-0.3|||Mixed Model Repeated Measures ANCOVA|||Week 3: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.3|-1.0|0.0005
70876331|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.28|||<|0.0001||95.0|-1.7|-0.9|||Mixed Model Repeated Measures ANCOVA|||Week 4: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.9|-1.7|<.0001
71151210|NCT03038880|141794348|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|4.76|||||TWO_SIDED|80.0|-1.19|10.72|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||10.72|-1.19|
71151211|NCT03038880|141794348|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|3.57|||||TWO_SIDED|80.0|-0.92|8.07|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||8.07|-0.92|
71151212|NCT03038880|141794349|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|0.45|||||TWO_SIDED|80.0|-29.81|30.71|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||30.71|-29.81|
71151213|NCT03038880|141794349|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|14.68|||||TWO_SIDED|80.0|-14.29|43.65|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||43.65|-14.29|
71151214|NCT03038880|141794349|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|-4.85|||||TWO_SIDED|80.0|-30.57|20.87|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||20.87|-30.57|
71151215|NCT03038880|141794349|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|1.12|||||TWO_SIDED|80.0|-23.57|25.8|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||25.80|-23.57|
71151216|NCT03038880|141794350|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|-12.23|||||TWO_SIDED|80.0|-36.6|12.15|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||12.15|-36.60|
70876332|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.94|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.6|||Mixed Model Repeated Measures ANCOVA|||Week 4: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.6|-1.3|<.0001
70876333|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 4: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.2|<.0001
70956682|NCT00141219|141416750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.245||0.12||95.0|-0.86|0.1||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 1 Sleep Interference Score~Pregabalin minus Placebo"||0.10|-0.86|0.120
71151217|NCT03038880|141794350|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|4.98|||||TWO_SIDED|80.0|-18.5|28.45|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||28.45|-18.50|
71151218|NCT03038880|141794350|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|-8.64|||||TWO_SIDED|80.0|-30.42|13.14|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||13.14|-30.42|
71151219|NCT03038880|141794350|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|7.36|||||TWO_SIDED|80.0|-13.65|28.37|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||28.37|-13.65|
71151220|NCT02054104|141794372|OTHER|||||||0.36|||||||Mann-Whitney U test|||||||0.36
71151221|NCT03926611|141794377|SUPERIORITY|LOU064 10 mg q.d.|LS Mean|-13.66|STANDARD_ERROR_OF_MEAN|2.334|<|0.0001|TWO_SIDED|90.0|-17.51|-9.81|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-9.81|-17.51|<0.0001
71151222|NCT03926611|141794377|SUPERIORITY|LOU064 35 mg q.d.|LS Mean|-13.64|STANDARD_ERROR_OF_MEAN|2.336|<|0.0001|TWO_SIDED|90.0|-17.49|-9.78|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-9.78|-17.49|<0.0001
71151223|NCT03926611|141794377|SUPERIORITY|LOU064 100 mg q.d.|LS Mean|-9.21|STANDARD_ERROR_OF_MEAN|2.277|<|0.0001|TWO_SIDED|90.0|-12.97|-5.45|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-5.45|-12.97|<0.0001
71151224|NCT03926611|141794377|SUPERIORITY|LOU064 10 mg b.i.d.|LS Mean|-10.55|STANDARD_ERROR_OF_MEAN|2.319|<|0.0001|TWO_SIDED|90.0|-14.38|-6.72|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-6.72|-14.38|<0.0001
71151225|NCT03926611|141794377|SUPERIORITY|LOU064 25 mg b.i.d.|LS Mean|-14.58|STANDARD_ERROR_OF_MEAN|2.334|<|0.0001|TWO_SIDED|90.0|-18.43|-10.73|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-10.73|-18.43|<0.0001
70876334|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.17|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.8|||Mixed Model Repeated Measures ANCOVA|||Week 5: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.8|-1.6|<.0001
71151226|NCT03926611|141794377|SUPERIORITY|LOU064 100 mg b.i.d.|LS Mean|-12.62|STANDARD_ERROR_OF_MEAN|2.327|<|0.0001|TWO_SIDED|90.0|-16.45|-8.78|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-8.78|-16.45|<0.0001
71151227|NCT03926611|141794378|SUPERIORITY|LOU064 10 mg q.d.|LS Mean|-10.24|STANDARD_ERROR_OF_MEAN|2.71|<|0.0001|TWO_SIDED|90.0|-14.72|-5.77|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-5.77|-14.72|<0.0001
71151228|NCT03926611|141794378|SUPERIORITY|LOU064 35 mg q.d.|LS Mean|-10.11|STANDARD_ERROR_OF_MEAN|2.711||0.0001|TWO_SIDED|90.0|-14.58|-5.63|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-5.63|-14.58|0.0001
71151229|NCT03926611|141794378|SUPERIORITY|LOU064 100 mg q.d.|LS Mean|-7.4|STANDARD_ERROR_OF_MEAN|2.635||0.0027|TWO_SIDED|90.0|-11.75|-3.05|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-3.05|-11.75|0.0027
71151230|NCT03926611|141794378|SUPERIORITY|LOU064 10 mg b.i.d.|LS Mean|-9.8|STANDARD_ERROR_OF_MEAN|2.696||0.0002|TWO_SIDED|90.0|-14.25|-5.35|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-5.35|-14.25|0.0002
71151231|NCT03926611|141794378|SUPERIORITY|LOU064 25 mg b.i.d.|LS Mean|-12.35|STANDARD_ERROR_OF_MEAN|2.714|<|0.0001|TWO_SIDED|90.0|-16.82|-7.87|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-7.87|-16.82|<0.0001
71151232|NCT03926611|141794378|SUPERIORITY|LOU064 100 mg b.i.d.|LS Mean|-9.52|STANDARD_ERROR_OF_MEAN|2.733||0.0003|TWO_SIDED|90.0|-14.03|-5.01|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-5.01|-14.03|0.0003
71151233|NCT00084136|141794386|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51|||<|0.01|TWO_SIDED|95.0|1.12|2.04||Not adjusted for multiple interim analyses. Peto-Haybittle spending function was used as a basis for calculating the repeated confidence intervals used in interim monitoring.|Log Rank|Log-rank test was stratified by country and screening RNA (\< 100,000 c/mL vs \>= 100,000 copies/mL).|The HR is for ddI+FTC+ATV vs. ZDV/3TC+EFV.|||2.04|1.12|<0.01
71151234|NCT00084136|141794387|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.72|1.27|||Other||The HR is for TDF/FTC+EFV vs. ZDV/3TC+EFV.|While original study design specified a non-inferiority test, study follow-up stopped early, not due to treatment effect size or futility, but due to slowing accumulation of primary outcome events. Therefore, 2-sided, 95% confidence intervals about the estimated treatment effect (relative effect estimated by a hazard ratio) are provided.||1.27|0.72|
71151235|NCT02230670|141794405|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.0817||0.091|TWO_SIDED|95.0|-0.302|0.023|||ANCOVA|||Analysis was conducted using an ANCOVA model adjusting for baseline value.||0.023|-0.302|0.091
71151236|NCT02230670|141794405|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.041|TWO_SIDED|95.0|-0.41|0.01|||ANCOVA|||The analysis was conducted using an ANCOVA model adjusting for baseline value, baseline MELD score, and etiology. The significance was assessed using Type II Sums of Squares from this ANCOVA model.||0.01|-0.41|0.041
71151237|NCT02230670|141794406|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.333||0.466|TWO_SIDED|95.0|-0.91|0.42|||ANCOVA|||Analysis was conducted using an ANCOVA model adjusting for baseline value.||0.42|-0.91|0.466
71151238|NCT02230670|141794406|SUPERIORITY||Median Difference (Final Values)|-2.19|STANDARD_ERROR_OF_MEAN|1.42||0.003|TWO_SIDED|95.0|-3.61|-0.77|||ANCOVA|calculated from the estimated least square means for the treatment by BL MELD category interaction term.||BL MELD \>= 15 subgroup results (N=19), as analyzed from the adjusted analysis ANCOVA model adjusting for baseline value, baseline MELD score, and etiology.||-0.77|-3.61|0.003
71151239|NCT02230670|141794406|SUPERIORITY||Median Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|1.46||0.029|TWO_SIDED|95.0|-3.09|-0.17|||ANCOVA|calculated from the estimated least square means for the treatment by etiology interaction term.||NASH Etiology subgroup results (N=20), as analyzed from the adjusted analysis ANCOVA model adjusting for baseline value, baseline MELD score, and etiology.||-0.17|-3.09|0.029
71151240|NCT03219528|141794441|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|||Baseline||||0.78
71151241|NCT03219528|141794441|SUPERIORITY|||||||0.88|||||||Mixed Models Analysis|||Week 5||||0.88
71151242|NCT03219528|141794450|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||Baseline||||0.77
71151243|NCT03219528|141794450|SUPERIORITY|||||||0.58|||||||Mixed Models Analysis|||Week 5||||0.58
71151244|NCT02120898|141794452|EQUIVALENCE|90% CI interval was -0.20 to +0.20 for therapeutic equivalence.|Percentage difference|-1.16||||0.0702|TWO_SIDED|90.0|-7.93|5.62|||Fisher Exact|||Analysis was performed using 90% Wald's confidence interval (CI) with a continuity correction or the difference (generic imiquimod - Zyclara) in complete clearance rates.||5.62|-7.93|0.0702
71151245|NCT02120898|141794453|SUPERIORITY||Percentage difference|0.14||||0.0318|TWO_SIDED|90.0|-6.08|6.35||Threshold for significance at 0.05 level.|Fisher Exact|||Analysis was performed using 90% Wald's CI with a continuity correction or the difference (generic imiquimod - Zyclara) in complete clearance rates.||6.35|-6.08|0.0318
71151246|NCT00043979|141794484|SUPERIORITY_OR_OTHER|||||||0.0003||||||7 participants who did not receive a transplant compared with 21 participants transplanted.|Kaplan-Meier|||||||.0003
71151247|NCT02919995|141794501|OTHER||Contrast ratio|1.038||||0.0196|TWO_SIDED|95.0|1.007|1.07|||ANCOVA|||||1.07|1.007|0.0196
71151248|NCT02919995|141794501|OTHER||Contrast ratio|1.024||||0.0802|TWO_SIDED|95.0|0.997|1.052|||ANCOVA|||||1.052|0.997|0.0802
71151249|NCT02919995|141794501|OTHER||Contrast ratio|0.986||||0.3487|TWO_SIDED|95.0|0.957|1.017|||ANCOVA|||||1.017|0.957|0.3487
71151250|NCT02919995|141794502|OTHER||Contrast ratio|1.072||||0.0043|TWO_SIDED|95.0|1.026|1.12|||ANCOVA|||||1.12|1.026|0.0043
71151251|NCT02919995|141794502|OTHER||Contrast ratio|1.055||||0.0109|TWO_SIDED|95.0|1.014|1.096|||ANCOVA|||||1.096|1.014|0.0109
71151252|NCT02919995|141794502|OTHER||Contrast ratio|0.984||||0.4306|TWO_SIDED|95.0|0.942|1.027|||ANCOVA|||||1.027|0.942|0.4306
71151253|NCT02919995|141794503|OTHER||Contrast ratio|1.065||||0.0064|TWO_SIDED|95.0|1.021|1.11|||ANCOVA|||||1.11|1.021|0.0064
71151254|NCT02919995|141794503|OTHER||Contrast ratio|1.049||||0.0149|TWO_SIDED|95.0|1.011|1.089|||ANCOVA|||||1.089|1.011|0.0149
71151255|NCT02919995|141794503|OTHER||Contrast ratio|0.945||||0.466|TWO_SIDED|95.0|0.945|1.027|||ANCOVA|||||1.027|0.945|0.466
71151256|NCT02919995|141794504|OTHER||Contrast ratio|1.061||||0.0093|TWO_SIDED|95.0|1.017|1.107|||ANCOVA|||||1.107|1.017|0.0093
71151257|NCT02919995|141794504|OTHER||Contrast ratio|1.042||||0.0333|TWO_SIDED|95.0|1.004|1.082|||ANCOVA|||||1.082|1.004|0.0333
71151258|NCT02919995|141794504|OTHER||Contrast ratio|0.982||||0.3693|TWO_SIDED|95.0|0.941|1.024|||ANCOVA|||||1.024|0.941|0.3693
71151259|NCT02691507|141794544|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71151260|NCT02691507|141794544|SUPERIORITY_OR_OTHER|||||||0.002||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.002
71151261|NCT02691507|141794544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.795||0.616|TWO_SIDED|95.0|-1.196|1.998||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.998|-1.196|0.616
70956683|NCT00141219|141416750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.246||0.041||95.0|-0.99|-0.02||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 2 Sleep Interference Score~Pregabalin minus Placebo"||-0.02|-0.99|0.041
71151262|NCT02691507|141794545|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71151263|NCT02691507|141794545|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71151264|NCT02691507|141794545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85|STANDARD_ERROR_OF_MEAN|0.803||0.297|TWO_SIDED|95.0|-0.767|2.46||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.460|-0.767|0.297
71151265|NCT02691507|141794546|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71151266|NCT02691507|141794546|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71151267|NCT02691507|141794546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73|STANDARD_ERROR_OF_MEAN|0.846||0.394|TWO_SIDED|95.0|-0.973|2.426||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.426|-0.973|0.394
71151268|NCT02691507|141794547|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71151269|NCT02691507|141794547|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71151270|NCT02691507|141794547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.708||0.69|TWO_SIDED|95.0|-1.14|1.709||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.709|-1.140|0.690
71151271|NCT02691507|141794548|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71151272|NCT02691507|141794548|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71151273|NCT02691507|141794548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.735||0.914|TWO_SIDED|95.0|-1.556|1.397||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.397|-1.556|0.914
71151274|NCT02691507|141794549|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71151275|NCT02691507|141794549|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71151276|NCT02691507|141794549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.774||0.757|TWO_SIDED|95.0|-1.796|1.314||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.314|-1.796|0.757
71151277|NCT02691507|141794550|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71151278|NCT02691507|141794550|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
70876335|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.87|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 5: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.3|<.0001
70876336|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.85|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 5: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.2|<.0001
70876337|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.31|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.9|||Mixed Model Repeated Measures ANCOVA|||Week 6: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.9|-1.7|<.0001
70876338|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 6: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.3|<.0001
70956684|NCT00141219|141416750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.248||0.017||95.0|-1.07|-0.1||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 3 Sleep Interference Score~Pregabalin minus Placebo"||-0.10|-1.07|0.017
70956685|NCT00141219|141416750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.249||0.033||95.0|-1.02|-0.04||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 4 Sleep Interference Score~Pregabalin minus Placebo"||-0.04|-1.02|0.033
70956686|NCT00141219|141416750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.25||0.078||95.0|-0.93|0.05||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 5 Sleep Interference Score~Pregabalin minus Placebo"||0.05|-0.93|0.078
70956687|NCT00141219|141416750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.25||0.038||95.0|-1.01|-0.03||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 6 Sleep Interference Score~Pregabalin minus Placebo"||-0.03|-1.01|0.038
70956688|NCT00141219|141416750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.252||0.037||95.0|-1.02|-0.03||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 7 Sleep Interference Score~Pregabalin minus Placebo"||-0.03|-1.02|0.037
70956689|NCT00141219|141416750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.252||0.015||95.0|-1.11|-0.12||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 8 Sleep Interference Score~Pregabalin minus Placebo"||-0.12|-1.11|0.015
70956690|NCT00141219|141416751|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.62|STANDARD_ERROR_OF_MEAN|2.639||0.034||95.0|-10.82|-0.42||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Sleep Disturbance~Pregabalin minus Placebo"||-0.42|-10.82|0.034
70956691|NCT00141219|141416752|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.05|STANDARD_ERROR_OF_MEAN|3.309||0.128||95.0|-1.47|11.58||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Snoring Score~Pregabalin minus Placebo"||11.58|-1.47|0.128
70956692|NCT00141219|141416753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.09|STANDARD_ERROR_OF_MEAN|1.887||0.103||95.0|-6.81|0.63||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Awaken Short of Breath or Headache~Pregabalin minus Placebo"||0.63|-6.81|0.103
71151279|NCT02691507|141794550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.798||0.556|TWO_SIDED|95.0|-2.075|1.129||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.129|-2.075|0.556
70956693|NCT00141219|141416754|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.182||0.018||95.0|0.08|0.8||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Sleep Quantity~Pregabalin minus Placebo"||0.80|0.08|0.018
70956694|NCT00141219|141416755|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.23|STANDARD_ERROR_OF_MEAN|0.37||0.504||95.0|0.67|2.24||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Regression, Logistic|OR estimated from model with Optimal sleep status (Yes/No) as response variable, and treatment, baseline Optimal sleep status as explanatory variables|"The OR estimates ratio of Odds of optimal sleep between Pregabalin and Placebo (ie, the former to the latter). Odds of optimal sleep in treatment group is ratio of Probability of having optimal sleep vs Probability of Not having optimal sleep"|"Week 8 Optimal Sleep~Optimal Sleep is a binary outcome derived from Sleep Quantity (SQ): the response is YES (or 1) if SQ = 7 or 8 hours per night.~Odds ratio measured the odds of optimal sleep in pregabalin to that in placebo.~Standard Error of the Mean equals Standard Error of the Odds Ratio (OR)."||2.24|0.67|.504
70956695|NCT00141219|141416756|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|3.796||0.571||95.0|-5.33|9.63||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Sleep Adequacy~Pregabalin minus Placebo"||9.63|-5.33|0.571
71151280|NCT02691507|141794551|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71151281|NCT02691507|141794551|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71151282|NCT02691507|141794551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.27|STANDARD_ERROR_OF_MEAN|0.772||0.106|TWO_SIDED|95.0|-2.824|0.278||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.278|-2.824|0.106
71151283|NCT02691507|141794552|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71151284|NCT02691507|141794552|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71151285|NCT02691507|141794552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.83|STANDARD_ERROR_OF_MEAN|6.681|<|0.001|TWO_SIDED|95.0|13.407|40.247||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||40.247|13.407|<0.001
71151286|NCT02691507|141794553|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71151287|NCT02691507|141794553|SUPERIORITY_OR_OTHER|||||||0.004||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.004
71151288|NCT02691507|141794553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.33|STANDARD_ERROR_OF_MEAN|3.996|<|0.001|TWO_SIDED|95.0|11.301|27.352||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||27.352|11.301|<0.001
71151289|NCT02691507|141794554|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71151290|NCT02691507|141794554|SUPERIORITY_OR_OTHER|||||||0.009||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.009
70956696|NCT00141219|141416757|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.71|STANDARD_ERROR_OF_MEAN|2.349||0.046||95.0|0.08|9.34||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Somnolence~Pregabalin minus Placebo"||9.34|0.08|0.046
70956697|NCT00141219|141416758|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.12|STANDARD_ERROR_OF_MEAN|2.044||0.3||95.0|-6.15|1.91||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Overall Sleep Problem~Pregabalin minus Placebo"||1.91|-6.15|0.300
70956698|NCT00141219|141416759|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.026|STANDARD_ERROR_OF_MEAN|0.0325||0.429||95.0|-0.038|0.09||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Endpoint Utility Score~Pregabalin minus Placebo"||0.090|-0.038|0.429
70956699|NCT00141219|141416760|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.5|STANDARD_ERROR_OF_MEAN|2.375||0.142||95.0|-1.18|8.18||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Endpoint VAS Score~Pregabalin minus Placebo"||8.18|-1.18|0.142
71151291|NCT02691507|141794554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.01|STANDARD_ERROR_OF_MEAN|4.072|<|0.001|TWO_SIDED|95.0|7.829|24.187||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||24.187|7.829|<0.001
71151292|NCT02691507|141794555|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71151293|NCT02691507|141794555|SUPERIORITY_OR_OTHER|||||||0.003||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.003
71151294|NCT02691507|141794555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.25|STANDARD_ERROR_OF_MEAN|3.764|<|0.001|TWO_SIDED|95.0|5.684|20.82||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||20.820|5.684|<0.001
71151295|NCT02691507|141794556|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71151296|NCT02691507|141794556|SUPERIORITY_OR_OTHER|||||||0.049||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.049
70956700|NCT00141219|141416761|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.409||0.038||95.0|-1.66|-0.05||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Endpoint Anxiety Score~Pregabalin minus Placebo"||-0.05|-1.66|0.038
70956701|NCT00141219|141416762|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.438||0.664||95.0|-1.05|0.67||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Endpoint Depression Score~Pregabalin minus Placebo"||0.67|-1.05|0.664
70956702|NCT00141219|141416763|SUPERIORITY_OR_OTHER_LEGACY|||||||0.473||95.0||||All statistical testing was 2-sided and was conducted at the 5% level of significance. p-value is from comparing Pregabalin versus Placebo.|Cochran-Mantel-Haenszel|"To apply CMH, each category is given a numerical score; the method of modified rdit used to assign numeric scores."||Cochran-Mantel-Haenszel (CMH) test on the null hypothesis of no treatment difference in all centers. CMH test comparing Pregabalin to Placebo adjusted for center.||||0.473
70956703|NCT00141219|141416764|SUPERIORITY_OR_OTHER_LEGACY|||||||0.119||95.0||||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Cochran-Mantel-Haenszel|"To apply CMH, each category is given a numerical score; the method of modified rdit used to assign numeric scores."||Cochran-Mantel-Haenszel (CMH) test on the null hypothesis of no treatment difference in all centers. CMH test comparing Pregabalin to Placebo adjusted for center.||||0.119
70956704|NCT02224690|141416766|SUPERIORITY||Median Difference (Final Values)|-17.21||||0.0135|TWO_SIDED|95.0|-30.32|-4.09|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach|||-4.09|-30.32|0.0135
70956705|NCT02224690|141416767|SUPERIORITY||Odds Ratio (OR)|2.57||||0.0043|TWO_SIDED|95.0|1.33|4.97|||Cochran-Mantel-Haenszel|Calculated using a Cochran-Mantel-Haenszel test stratified by age group (2-5, 6-11, 12-17 and 18-55 years)||||4.97|1.33|0.0043
70956706|NCT02224690|141416768|SUPERIORITY||Mean Difference (Final Values)|-21.13||||0.0005|TWO_SIDED|95.0|-33.26|-9.37|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach|||-9.37|-33.26|0.0005
70956707|NCT02224690|141416769|SUPERIORITY||Odds Ratio (OR)|2.54||||0.0012|TWO_SIDED|95.0|1.45|4.47|||Regression, Logistic|Ordinal logistic regression model with treatment group as a fixed factor.|Odds of participants recording a lower score (improvement) on a continuous scale|||4.47|1.45|0.0012
70956708|NCT00122460|141416772|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.797||||0.036|TWO_SIDED|95.0|0.644|0.986|||Stratified Log Rank|||"The primary analysis tested the equality of OS between treatment groups applying a 2-sided stratified log-rank test (α=5%), taking into account the strata used for randomization (previous chemotherapy (CTX) \[no vs. yes\] and Karnofsky Performance Status (KPS) \[\<80 vs. ≥80\]).~Median overall survival was estimated using the Kaplan-Meier method. The Hazard Ratio (HR) of cetuximab + CTX over CTX alone was calculated using the Cox proportional hazards model stratified by randomization strata."||0.986|0.644|0.036
70956709|NCT00122460|141416773|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.538|||<|0.0001|TWO_SIDED|95.0|0.431|0.672|||Stratified Log Rank|||"To test the equality of PFS between treatment groups, a two-sided stratified log-rank test (α=5%)was used, taking into account strata used for randomization (previous CTX \[yes/no\] and KPS \[\<80 vs. ≥80\]).~Median PFS time was estimated using the Kaplan-Meier method. The HR of cetuximab + CTX over CTX alone was calculated using the Cox proportional hazards model stratified by randomization strata."||0.672|0.431|<0.0001
70956710|NCT00122460|141416774|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.326||||0.0001|TWO_SIDED|95.0|1.504|3.6|||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel (CMH) test was performed using the randomization strata previous CTX (no vs. yes) and KPS (\<80 vs. ≥80). Treatment group comparisons were performed two-sided with α=5%.||3.600|1.504|0.0001
70956711|NCT00122460|141416775|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.881|||<|0.0001|TWO_SIDED|95.0|1.87|4.441|||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel (CMH) test was performed using the randomization strata previous CTX (no vs. yes) and KPS (\<80 vs. ≥80). Treatment group comparisons were performed two-sided with α=5%.||4.441|1.870|<0.0001
70956712|NCT00122460|141416776|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.593|||<|0.0001|TWO_SIDED|95.0|0.484|0.727|||Stratified Log Rank|||"Treatment groups were compared applying a two-sided stratified log-rank test (α=5%), taking into account strata used for randomization (previous CTX \[yes/no\] and KPS \[\<80 vs. ≥80\]).~Median time to treatment failure was estimated using the Kaplan-Meier method. The HR of cetuximab + CTX over CTX alone was calculated using the Cox proportional hazards model stratified by randomization strata."||0.727|0.484|<0.0001
71151297|NCT02691507|141794556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.08|STANDARD_ERROR_OF_MEAN|4.138||0.001|TWO_SIDED|95.0|5.766|22.387||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||22.387|5.766|0.001
71151298|NCT02691507|141794557|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71151299|NCT02691507|141794557|SUPERIORITY_OR_OTHER|||||||0.024||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.024
70956713|NCT00122460|141416777|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.762||||0.21|TWO_SIDED|95.0|0.497|1.168|||Stratified Log Rank|||"To test the equality of duration of response between treatment groups, the two-sided stratified log-rank test (α=5%) was used taking strata used for randomization into account (previous CTX \[no vs. yes\] and KPS \[\<80 vs. ≥80\]).~Median duration of response was estimated using the Kaplan-Meier method. The HR of cetuximab + CTX over CTX alone was calculated using the Cox proportional hazards model stratified by randomization strata."||1.168|0.497|0.21
70956714|NCT01506609|141416781|SUPERIORITY||Hazard Ratio (HR)|0.789||||0.227|TWO_SIDED|95.0|0.536|1.162|||Log Rank|||||1.162|0.536|0.227
70956715|NCT01506609|141416781|SUPERIORITY||Hazard Ratio (HR)|1.858||||0.001|TWO_SIDED|95.0|1.278|2.702|||Log Rank|||||2.702|1.278|0.001
70956716|NCT01506609|141416782|SUPERIORITY||Hazard Ratio (HR)|0.848||||0.368|TWO_SIDED|95.0|0.59|1.218|||Log Rank|||||1.218|0.590|0.368
70956717|NCT01506609|141416782|SUPERIORITY||Hazard Ratio (HR)|1.512||||0.017|TWO_SIDED|95.0|1.074|2.127|||Log Rank|||||2.127|1.074|0.017
70956718|NCT01506609|141416783|SUPERIORITY|||||||0.434||||||P-value is from Cochran-Mantel-Haenszel test stratified by estrogen receptor/progesterone receptor status and prior cytotoxic therapy use.|Cochran-Mantel-Haenszel|||||||0.434
70956719|NCT01506609|141416783|SUPERIORITY|||||||0.019||||||P-value is from Cochran-Mantel-Haenszel test stratified by estrogen receptor/progesterone receptor status and prior cytotoxic therapy use.|Cochran-Mantel-Haenszel|||||||0.019
70956720|NCT01506609|141416784|SUPERIORITY|||||||0.027||||||P-value is from Cochran-Mantel-Haenszel test stratified by estrogen receptor/progesterone receptor status and prior cytotoxic therapy use.|Cochran-Mantel-Haenszel|||||||0.027
70956721|NCT01506609|141416784|SUPERIORITY||||||<|0.001||||||P-value is from Cochran-Mantel-Haenszel test stratified by estrogen receptor/progesterone receptor status and prior cytotoxic therapy use.|Cochran-Mantel-Haenszel|||||||< 0.001
70956722|NCT01506609|141416785|SUPERIORITY||Least Squares (LS) Mean of Difference|-2.302|STANDARD_ERROR_OF_MEAN|2.476||0.354|TWO_SIDED|95.0|-7.2|2.6||ANCOVA with treatment arm and baseline value as covariate.|ANCOVA|||||2.60|-7.20|0.354
70956723|NCT02595073|141416809|SUPERIORITY|||||||0.3353|||||||z-test, 2-tailed|||||||0.3353
70956724|NCT02595073|141416810|SUPERIORITY|||||||0.619|||||||ANCOVA|||||||0.6190
70956725|NCT00467350|141416852|SUPERIORITY_OR_OTHER_LEGACY|"Similar to previous studies, the main outcome measure was the change in the child's main symptom. Changes were determined by the question Has your child's main symptom improved, stayed the same or gotten worse? The main symptom was defined as the chief complaint identified during the triage process. For analysis, responses were dichotomized into 2 groups: improved/better versus worse/same."|||||||||||||||||A χ2 test was used to examine the difference in probabilities of experiencing an outcome between treatment arms and differences were expressed by Mantel-Haenszel common OR estimate with 95% confidence interval (CI).|||
70956726|NCT03538301|141416854|SUPERIORITY||Slope|-0.004153||||0.049|TWO_SIDED|95.0|-0.008284|-0.000021|||random coefficient model|||Slope in FVC (L/week) in the 45 mg cohort versus placebo||-0.000021|-0.008284|0.049
70956727|NCT03538301|141416854|SUPERIORITY||Slope|-0.002112||||0.316|TWO_SIDED|95.0|-0.00626|0.002036|||random coefficient model|||Slope in FVC (L/week) in the 90 mg cohort versus placebo||0.002036|-0.006260|0.316
70956728|NCT03538301|141416855|SUPERIORITY||Slope|-0.091238||||0.098|TWO_SIDED|95.0|-0.199456|0.016979|||random coefficient model|||||0.016979|-0.199456|0.098
70956729|NCT03538301|141416855|SUPERIORITY||Slope|-0.039596||||0.473|TWO_SIDED|95.0|-0.148248|0.069056|||random coefficient model|||||0.069056|-0.148248|0.473
70956730|NCT03538301|141416856|SUPERIORITY||Mean Difference (Final Values)|-0.0997||||0.049|TWO_SIDED|95.0|-0.1988|-0.0005|||random coefficient model|||Change from Baseline to Week 24 in FVC (L) in the 45 mg cohort versus placebo||-0.0005|-0.1988|0.049
70956731|NCT03538301|141416856|SUPERIORITY||Mean Difference (Final Values)|-0.0507||||0.316|TWO_SIDED|95.0|-0.1502|0.0489|||random coefficient model|||Change from Baseline to Week 24 in FVC (L) in the 90 mg cohort versus placebo||0.0489|-0.1502|0.316
70956732|NCT03538301|141416857|SUPERIORITY||Median Difference (Final Values)|-3.16||||0.668|TWO_SIDED|95.0|-17.59|11.28|||random coefficient model|||||11.28|-17.59|0.668
70956733|NCT03538301|141416857|SUPERIORITY||Median Difference (Final Values)|-1.72||||0.821|TWO_SIDED|95.0|-16.57|13.13|||random coefficient model|||||13.13|-16.57|0.821
70956734|NCT03538301|141416858|SUPERIORITY||Median Difference (Final Values)|-2.1897||||0.098|TWO_SIDED|95.0|-4.7869|0.4075|||random coefficient model|||Change from baseline to Week 24 in ppFVC||0.4075|-4.7869|0.098
70956735|NCT03538301|141416858|SUPERIORITY||Median Difference (Final Values)|-0.9503||||0.473|TWO_SIDED|95.0|-3.5579|1.6573|||random coefficient model|||Change from Baseline to Week 24 in ppFVC||1.6573|-3.5579|0.473
70956736|NCT03538301|141416859|SUPERIORITY||Median Difference (Final Values)|-2.53||||0.7|TWO_SIDED|95.0|-15.4|10.34|||random coefficient model|||||10.34|-15.40|0.700
70956737|NCT03538301|141416859|SUPERIORITY||Median Difference (Final Values)|-1.12||||0.867|TWO_SIDED|95.0|-14.31|12.07|||random coefficient model|||||12.07|-14.31|0.867
70956738|NCT03538301|141416862|SUPERIORITY||Mean Difference (Final Values)|0.146||||0.708|TWO_SIDED|95.0|-0.6226|0.9147|||random coefficient|||Change from Baseline to Week 24 in DLCO Corrected for Hemoglobin (mL/min/mmHg) in the 45 mg cohort versus placebo||0.9147|-0.6226|0.708
70956739|NCT03538301|141416862|SUPERIORITY||Mean Difference (Final Values)|0.7038||||0.074|TWO_SIDED|95.0|-0.0695|1.4771|||random coefficient|||Change from Baseline to Week 24 in DLCO Corrected for Hemoglobin (mL/min/mmHg) in the 90 mg cohort versus placebo||1.4771|-0.0695|0.074
70956740|NCT03538301|141416862|SUPERIORITY||Mean Difference (Final Values)|0.114||||0.765|TWO_SIDED|95.0|-0.6362|0.8641|||random coefficient model|||Change from Baseline to Week 24 in DLCO Not Corrected for Hemoglobin (mL/min/mmHg) in the 45 mg cohort versus placebo||0.8641|-0.6362|0.765
70956741|NCT03538301|141416862|SUPERIORITY||Mean Difference (Final Values)|0.556||||0.148|TWO_SIDED|95.0|-0.1986|1.3107|||random coefficient model|||Change from Baseline to Week 24 in DLCO Not Corrected for Hemoglobin (mL/min/mmHg) in the 90 mg cohort versus placebo||1.3107|-0.1986|0.148
70956742|NCT03538301|141416863|SUPERIORITY||Mean Difference (Final Values)|-0.48||||0.765|TWO_SIDED|95.0|-3.68|2.71|||random coefficient model|||Change from Baseline to Week 24 in QLF Score (% of whole lung field volume) in the 45 mg cohort versus placebo||2.71|-3.68|0.765
70956743|NCT03538301|141416863|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.37|TWO_SIDED|95.0|-1.68|4.47|||random coefficient model|||Change from Baseline to Week 24 in QLF Score (% of whole lung field volume) in the 90 mg cohort versus placebo||4.47|-1.68|0.370
70956744|NCT03538301|141416863|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.499|TWO_SIDED|95.0|-0.7|0.34|||random coefficient model|||Change from Baseline to Week 24 in Ground Glass Opacity (% of whole lung field volume) in the 45 mg cohort versus placebo||0.34|-0.70|0.499
70956745|NCT03538301|141416863|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.901|TWO_SIDED|95.0|-0.47|0.54|||random coefficient model|||Change from Baseline to Week 24 in Ground Glass Opacity (% of whole lung field volume) in the 90 mg cohort versus placebo||0.54|-0.47|0.901
70956746|NCT03538301|141416863|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.676|TWO_SIDED|95.0|-2.25|3.46|||random coefficient model|||Change from Baseline to Week 24 in Reticulation (% of whole lung field volume) in the 45 mg cohort versus placebo||3.46|-2.25|0.676
70956747|NCT03538301|141416863|SUPERIORITY||Mean Difference (Final Values)|1.64||||0.242|TWO_SIDED|95.0|-1.13|4.42|||random coefficient model|||Change from Baseline to Week 24 in Reticulation (% of whole lung field volume) in the 90 mg cohort versus placebo||4.42|-1.13|0.242
70956748|NCT03538301|141416863|SUPERIORITY||Mean Difference (Final Values)|-1.21||||0.14|TWO_SIDED|95.0|-2.82|0.4|||random coefficient model|||Change from Baseline to Week 24 in Honeycombing (% of whole lung field volume) in the 45 mg cohort versus placebo||0.40|-2.82|0.140
70956749|NCT03538301|141416863|SUPERIORITY||Mean Difference (Final Values)|-0.98||||0.211|TWO_SIDED|95.0|-2.53|0.56|||random coefficient model|||Change from Baseline to Week 24 in Honeycombing (% of whole lung field volume) in the 90 mg cohort versus placebo||0.56|-2.53|0.211
70956750|NCT03538301|141416863|SUPERIORITY||Mean Difference (Final Values)|0.88||||0.568|TWO_SIDED|95.0|-2.16|3.91|||random coefficient model|||Change from Baseline to Week 24 in Normal Lung (% of whole lung field volume) in the 45 mg cohort versus placebo||3.91|-2.16|0.568
70956751|NCT03538301|141416863|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.573|TWO_SIDED|95.0|-3.76|2.09|||random coefficient model|||Change from Baseline to Week 24 in Normal Lung (% of whole lung field volume) in the 90 mg cohort versus placebo||2.09|-3.76|0.573
70956752|NCT03538301|141416863|SUPERIORITY||Mean Difference (Final Values)|-3.58||||0.012|TWO_SIDED|95.0|-6.35|-0.81|||random coefficient model|||Change from Baseline to Week 24 in Emphysema (% of whole lung field volume) in the 45 mg cohort versus placebo||-0.81|-6.35|0.012
70956753|NCT03538301|141416863|SUPERIORITY||Mean Difference (Final Values)|-2.16||||0.112|TWO_SIDED|95.0|-4.82|0.51|||random coefficient model|||Change from Baseline to Week 24 in Emphysema (% of whole lung field volume) in the 90 mg cohort versus placebo||0.51|-4.82|0.112
70956754|NCT03538301|141416864|SUPERIORITY|||||||0.256|||||||Wilcoxon (Mann-Whitney)|||||||0.256
70956755|NCT03538301|141416864|SUPERIORITY|||||||0.241|||||||Wilcoxon (Mann-Whitney)|||||||0.241
70956756|NCT03538301|141416865|SUPERIORITY||Hazard Ratio (HR)|0.649||||0.517|TWO_SIDED|95.0|0.189|2.225|||Log Rank|||Time to First IPF Exacerbation or Death (weeks) in the 45 mg cohort versus placebo||2.225|0.189|0.517
70956757|NCT03538301|141416865|SUPERIORITY||Hazard Ratio (HR)|0.678||||0.506|TWO_SIDED|95.0|0.198|2.324|||Log Rank|||Time to First IPF Exacerbation or Death (weeks) in the 90 mg cohort versus placebo||2.324|0.198|0.506
70956758|NCT03538301|141416865|SUPERIORITY||Proportion Difference (Final Values)|-9.3||||0.313|TWO_SIDED|95.0|-25.2|5.5|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of First IPF Exacerbation (%) in the 45 mg cohort versus placebo||5.5|-25.2|0.313
70956759|NCT03538301|141416865|SUPERIORITY|The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Proportion Difference (Final Values)|-6.7||||0.376|TWO_SIDED|95.0|-22.6|9.2|||Chi-squared|||Rate of First IPF Exacerbation (%) in the 90 mg cohort versus placebo||9.2|-22.6|0.376
70956760|NCT03538301|141416866|SUPERIORITY||Proportion Difference (Final Values)|-4.6||||0.713|TWO_SIDED|95.0|-19.2|9.6|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of Hospitalization for Respiratory Ailments (%) in the 45 mg cohort versus placebo||9.6|-19.2|0.713
70956761|NCT03538301|141416866|SUPERIORITY||Proportion Difference (Final Values)|-4.4||||0.713|TWO_SIDED|95.0|-19.2|10.7|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of Hospitalization for Respiratory Ailments (%) in the 90 mg cohort versus placebo||10.7|-19.2|0.713
70956762|NCT03538301|141416867|SUPERIORITY|||||||0.937|||||||Log Rank|||Overall Survival (weeks) in the 45 mg cohort versus placebo||||0.937
70956763|NCT03538301|141416867|SUPERIORITY|||||||0.414|||||||Log Rank|||Overall Survival (weeks) in the 90 mg cohort versus placebo||||0.414
70956764|NCT03538301|141416867|SUPERIORITY||Proportion Difference (Final Values)|0.1|||>|0.999|TWO_SIDED|95.0|-10.4|10.9|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of Mortality (%) in the 45 mg cohort versus placebo||10.9|-10.4|>0.999
70956765|NCT03538301|141416867|SUPERIORITY||Proportion Difference (Final Values)|-2.4|||>|0.999|TWO_SIDED|95.0|-13.1|6.8|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of Mortality (%) in the 90 mg cohort versus placebo||6.8|-13.1|>0.999
70956766|NCT03538301|141416868|SUPERIORITY||Proportion Difference (Final Values)|-4.8||||0.494|TWO_SIDED|95.0|-16.6|4.6|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of Deterioration of IPF Resulting in Lung Transplantation (%) in the 45 mg cohort versus placebo||4.6|-16.6|0.494
70956767|NCT03538301|141416868|SUPERIORITY||Proportion Difference (Final Values)|-4.8||||0.494|TWO_SIDED|95.0|-16.2|4.5|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of Deterioration of IPF Resulting in Lung Transplantation (%) in the 90 mg cohort versus placebo||4.5|-16.2|0.494
70956768|NCT02842151|141416885|EQUIVALENCE|Difference in A-Constant is manifest refraction minus autorefraction. The criteria for equivalence (based on paired difference t-test) was established if the bounds of the 90% two-sided confidence interval (CI) on the difference was contained within the equivalence range (-0.15, 0.15).|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|0.346|||TWO_SIDED|90.0|-0.03|0.13||||||To demonstrate equivalency at Site 1, A-constant with manifest refraction was compared to A-constant with autorefraction.||0.13|-0.03|
71151300|NCT02691507|141794557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.26|STANDARD_ERROR_OF_MEAN|4.679||0.004|TWO_SIDED|95.0|4.862|23.66||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||23.660|4.862|0.004
70876339|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.72||||0.0003|TWO_SIDED|95.0|-1.1|-0.3|||Mixed Model Repeated Measures ANCOVA|||Week 6: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.3|-1.1|0.0003
71151301|NCT02691507|141794558|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
70876340|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.9|||Mixed Model Repeated Measures ANCOVA|||Week 7: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.9|-1.7|<.0001
70876341|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 7: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.3|<.0001
71151302|NCT02691507|141794558|SUPERIORITY_OR_OTHER|||||||0.015||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.015
71151303|NCT02691507|141794558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.77|STANDARD_ERROR_OF_MEAN|4.222||0.004|TWO_SIDED|95.0|4.291|21.252||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||21.252|4.291|0.004
71151304|NCT02691507|141794559|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71151305|NCT02691507|141794559|SUPERIORITY_OR_OTHER|||||||0.034||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.034
71151306|NCT02691507|141794559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.71|STANDARD_ERROR_OF_MEAN|5.925||0.037|TWO_SIDED|95.0|0.805|24.621||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||24.621|0.805|0.037
71151307|NCT04634253|141794614|SUPERIORITY||LS Mean|-0.88|STANDARD_ERROR_OF_MEAN|0.361||0.017|TWO_SIDED|95.0|-1.6|-0.16|||Mixed Models Analysis|||||-0.16|-1.60|0.017
71151308|NCT04634253|141794614|SUPERIORITY||LS Mean|-1.09|STANDARD_ERROR_OF_MEAN|0.32|<|0.001|TWO_SIDED|95.0|-1.73|-0.46|||Mixed Models Analysis|||||-0.46|-1.73|<0.001
71151309|NCT04634253|141794615|SUPERIORITY||Odds Ratio (OR)|1.0||||0.997|TWO_SIDED|95.0|0.29|3.44|||Regression, Logistic|||||3.44|0.29|0.997
71151310|NCT04634253|141794615|SUPERIORITY||Odds Ratio (OR)|3.4||||0.032|TWO_SIDED|95.0|1.11|10.4|||Regression, Logistic|||||10.40|1.11|0.032
71151311|NCT04634253|141794616|SUPERIORITY||Odds Ratio (OR)|0.29||||0.235|TWO_SIDED|95.0|0.04|2.25|||Regression, Logistic|||||2.25|0.04|0.235
71151312|NCT04634253|141794616|SUPERIORITY||Odds Ratio (OR)|1.37||||0.661|TWO_SIDED|95.0|0.33|5.61|||Regression, Logistic|||||5.61|0.33|0.661
71151313|NCT04634253|141794617|SUPERIORITY||Odds Ratio (OR)|0.97||||0.965|TWO_SIDED|95.0|0.22|4.28|||Regression, Logistic|||||4.28|0.22|0.965
71151314|NCT04634253|141794617|SUPERIORITY||Odds Ratio (OR)|2.91||||0.098|TWO_SIDED|95.0|0.82|10.33|||Regression, Logistic|||||10.33|0.82|0.098
71151315|NCT04634253|141794618|SUPERIORITY||LS Mean Difference|-11.26|STANDARD_ERROR_OF_MEAN|3.71||0.003|TWO_SIDED|95.0|-18.65|-3.87|||Mixed Models Analysis|||||-3.87|-18.65|0.003
71151316|NCT04634253|141794618|SUPERIORITY||LS Mean Difference|-13.1|STANDARD_ERROR_OF_MEAN|3.265|<|0.001|TWO_SIDED|95.0|-19.61|-6.6|||Mixed Models Analysis|||||-6.60|-19.61|<0.001
71151317|NCT04634253|141794619|SUPERIORITY||LS Mean Difference|-10.3|STANDARD_ERROR_OF_MEAN|3.782||0.008|TWO_SIDED|95.0|-17.83|-2.77|||Mixed Models Analysis|||||-2.77|-17.83|0.008
71151318|NCT04634253|141794619|SUPERIORITY||LS Mean Difference|-11.76|STANDARD_ERROR_OF_MEAN|3.282|<|0.001|TWO_SIDED|95.0|-18.29|-5.22|||Mixed Models Analysis|||||-5.22|-18.29|<0.001
71151319|NCT04634253|141794620|SUPERIORITY||LS Mean Difference|-2.93|STANDARD_ERROR_OF_MEAN|2.365||0.218|TWO_SIDED|95.0|-7.63|1.77|||ANCOVA|||Mental Component Score (MCS)||1.77|-7.63|0.218
71151320|NCT04634253|141794620|SUPERIORITY||LS Mean Difference|1.15|STANDARD_ERROR_OF_MEAN|2.065||0.578|TWO_SIDED|95.0|-2.95|5.26|||ANCOVA|||Mental Component Score (MCS)||5.26|-2.95|0.578
71151321|NCT04634253|141794620|SUPERIORITY||LS Mean Difference|2.02|STANDARD_ERROR_OF_MEAN|2.368||0.396|TWO_SIDED|95.0|-2.69|6.73|||ANCOVA|||Physical Component Score (PCS)||6.73|-2.69|0.396
71151322|NCT04634253|141794620|SUPERIORITY||LS Mean Difference|1.42|STANDARD_ERROR_OF_MEAN|2.057||0.493|TWO_SIDED|95.0|-2.67|5.5|||ANCOVA|||Physical Component Score (PCS)||5.50|-2.67|0.493
71151323|NCT01356277|141794635|SUPERIORITY||Odds Ratio (OR)|1.66||||0.006|TWO_SIDED|95.0|1.15|2.39|||Regression, Logistic|Unadjusted, ordinal logistic regression|An odds ratio greater than 1.0 indicates higher adherence in Intervention participants compared with controls.|We estimated a sample size of 75 participants per group to have 85% power to detect a 20% difference in taking adherence between groups, using 2-sided tests and setting alpha at 0.05, assuming a common standard deviation of 40%. Targeted enrollment of 176 participants accounted for 15% drop-out. Only participants with electronic pillbox data could be included. For participants who withdrew or stopped using the pillbox, all available pillbox data were included.||2.39|1.15|0.006
71151324|NCT01356277|141794636|SUPERIORITY||Odds Ratio (OR)|1.74||||0.003|TWO_SIDED|95.0|1.21|2.5|||Regression, Logistic|Unadjusted ordinal logistic regression|An odds ratio greater than 1.0 indicates higher adherence in Intervention participants compared with controls.|||2.50|1.21|0.003
71151325|NCT01356277|141794637|SUPERIORITY|||||||0.49|||||||Wilcoxon ranksum|||Null hypothesis was that there was no difference in the SD of tacrolimus trough levels between intervention and control.||||0.49
71151326|NCT01356277|141794638|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
71151327|NCT01356277|141794639|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
71151328|NCT01356277|141794640|SUPERIORITY|||||||0.26|||||||Chi-squared|||Rates were compared between intervention and control groups using Chi square||||0.26
71151329|NCT01356277|141794641|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||.45
71151330|NCT05006573|141794647|SUPERIORITY||Risk Ratio (RR)|1.14||||0.5911|TWO_SIDED|95.0|0.71|1.82|||negative binomial model|marginal standardization method|The rate ratio (Benralizumab/Placebo) and its 95% CI are estimated using a negative binomial model. The covariates include treatment arm, baseline blood eosinophil category, and number of exacerbations from previous year.|||1.82|0.71|0.5911
71151331|NCT05006573|141794648|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.6677|TWO_SIDED|95.0|0.67|1.91|||Regression, Cox||The analysis is performed using cox proportional hazards model with covariates of treatment group, number of exacerbations in previous year and baseline eosinophil category.|||1.91|0.67|0.6677
71151332|NCT05232682|141794661|OTHER||F-test|2.41||||0.1183|TWO_SIDED|||||Alpha value for significance set at p \< .05.|Mixed Models Analysis|||||||0.1183
71151333|NCT05232682|141794662|OTHER||F-test|0.07||||0.9308|TWO_SIDED|||||Alpha value for significance set at p \< .05.|Mixed Models Analysis|||||||0.9308
71151334|NCT05232682|141794663|OTHER||F-test|2.1||||0.1517|TWO_SIDED|||||Alpha value for significance set at p \< .05.|Mixed Models Analysis|||||||0.1517
71151335|NCT05232682|141794664|OTHER||F-test|0.14||||0.8747|TWO_SIDED|||||Alpha value for significance set at p \< .05.|Mixed Models Analysis|||||||0.8747
71151336|NCT05232682|141794665|OTHER||F-test|1.19||||0.3269|TWO_SIDED|||||Alpha value for significance set at p \< .05.|Mixed Models Analysis|||||||0.3269
71151337|NCT05232682|141794666|OTHER||F-test|1.14||||0.3411|TWO_SIDED|||||Alpha value for significance set at p \< .05.|Mixed Models Analysis|||||||0.3411
71151338|NCT01646125|141794717|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.76|||||TWO_SIDED|90.0|0.35|1.63||||||||1.63|0.35|
71151339|NCT05462756|141794730|NON_INFERIORITY|The sample size provided \>99% statistical power to show noninferiority assuming a 0.4% noninferiority margin (NIM), in insulin efsitora doses compared to insulin glargine, in a 1:1 randomization, a standard deviation (SD) of 1.1%, and a dropout rate of 15%.|LS Mean Difference|-0.012|||||TWO_SIDED|95.0|-0.14|0.116||||||Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + Personal Use of CGM or FGM at Randomization + Treatment (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed.||0.116|-0.140|
71151340|NCT05462756|141794731|SUPERIORITY||LS Mean Difference|-0.012||||0.855|TWO_SIDED|95.0|-0.14|0.116|||ANCOVA|||Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + Personal Use of CGM or FGM at Randomization + Treatment (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed.||0.116|-0.140|0.855
71151341|NCT05462756|141794732|SUPERIORITY||Odds Ratio (OR)|1.11||||0.504|TWO_SIDED|95.0|0.81|1.52|||Chi-squared|||||1.52|0.81|0.504
71151342|NCT05462756|141794733|SUPERIORITY||Relative rate|0.67||||0.058|TWO_SIDED|95.0|0.44|1.01|||Negative binomial model||Relative rate is the ratio of the group means (Insulin Efsitora vs Insulin Glargine).|Group mean is determined by Negative Binomial Model using Number of episodes = Baseline hypoglycemia rate + Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable.||1.01|0.44|0.058
71151343|NCT05462756|141794734|SUPERIORITY||LS Mean Difference|-4.29||||0.104|TWO_SIDED|95.0|-9.461|0.886|||ANCOVA|||LS Mean was determined using ANCOVA model using Baseline + Country + Personal Use of CGM or FGM at Randomization + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares) as variables. Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed with one for each of the 100 datasets imputed at Baseline.||0.886|-9.461|0.104
71151344|NCT05462756|141794735|SUPERIORITY||LS Mean Difference|1.35||||0.337|TWO_SIDED|95.0|-1.404|4.101|||ANCOVA|||LS Mean was determined using ANCOVA model using Baseline + Country + Personal Use of CGM or FGM at Randomization + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares) as variables. Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at Week 22-Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed with one for each of the 100 datasets imputed at Baseline.||4.101|-1.404|0.337
71151345|NCT05462756|141794736|SUPERIORITY||LS Mean Difference|1.59||||0.104|TWO_SIDED|95.0|-0.327|3.508|||ANCOVA|||LS Mean was determined by ANCOVA model using Baseline + Country + Personal Use of CGM or FGM at Randomization + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares) as variables. Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at Week 22-Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed with one for each of the 100 datasets imputed at Baseline.||3.508|-0.327|0.104
71151346|NCT05462756|141794737|SUPERIORITY||LS Mean Difference|-1.5||||0.304|TWO_SIDED|95.0|-4.358|1.36|||ANCOVA|||LS Mean was determined by ANCOVA model using Baseline + Country + Personal Use of CGM or FGM at Randomization + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares). Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at Week 22-Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed with one for each of the 100 datasets imputed at Baseline.||1.360|-4.358|0.304
71151347|NCT05462756|141794738|SUPERIORITY||LS Mean Difference|0.23||||0.523|TWO_SIDED|95.0|-0.48|0.95|||Mixed Models Analysis|||LS Mean was determined by MMRM model with BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Personal Use CGM or FGM at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Unstructured variance-covariance structure was used.||0.95|-0.48|0.523
71151348|NCT05462756|141794739|SUPERIORITY||LS Mean Difference|-35.04|||<|0.001|TWO_SIDED|95.0|-55.57|-14.5|||Mixed Models Analysis|||LS Mean was determined by Mixed Model Repeated Measures (MMRM) model using BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Personal Use CGM or FGM at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry.||-14.50|-55.57|<0.001
71151349|NCT05462756|141794740|SUPERIORITY||LS Mean Difference|-7.55|||<|0.001|TWO_SIDED|95.0|-10.79|-4.3|||Mixed Models Analysis|||LS Mean was determined by MMRM model using BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Personal Use CGM or FGM at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry.||-4.30|-10.79|<0.001
71151350|NCT05462756|141794741|SUPERIORITY||LS Mean Difference|-73.5|||<|0.001|TWO_SIDED|95.0|-107.81|-39.2|||Mixed Models Analysis|||LS Mean was determined by MMRM model using BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Personal Use CGM or FGM at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry.||-39.20|-107.81|<0.001
71151351|NCT05462756|141794742|SUPERIORITY||LS Mean Difference|3.53|||<|0.001|TWO_SIDED|95.0|1.49|5.58|||Mixed Models Analysis|||LS Mean was determined by MMRM model using BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Personal Use CGM or FGM at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry.||5.58|1.49|<0.001
71151352|NCT05462756|141794743|SUPERIORITY||Mean Difference (Net)|1.11||||0.442|TWO_SIDED|95.0|0.85|1.44|||Negative binomial model|||Group mean was reported and determined by Negative binomial method using Baseline hypoglycemia rate + Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as variables.||1.44|0.85|0.442
71151353|NCT05462756|141794744|SUPERIORITY||LS Mean Difference|0.14||||0.543|TWO_SIDED|95.0|-0.32|0.6|||Mixed Models Analysis|||LS Mean was determined by MMRM model using BASELINE + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.60|-0.32|0.543
71151354|NCT05462756|141794745|SUPERIORITY||LS Mean Difference|1.8||||0.099|TWO_SIDED|95.0|-0.3|4.0|||ANCOVA|||LS Mean was determined by ANCOVA model using Country + Personal Use CGM or FGM at Randomization + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares) as variables.||4.0|-0.3|0.099
71151355|NCT04040933|141794748|OTHER|Change from Baseline in TEWL measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each baseline score within each treatment using paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.86|TWO_SIDED||||||ANCOVA|||||||0.860
71151356|NCT04040933|141794748|OTHER|Change from Baseline in TEWL measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each baseline score within each treatment using paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.051|||||||ANCOVA|||||||0.051
71151357|NCT04040933|141794749|OTHER|Change from Baseline in Erythema measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.259|TWO_SIDED||||||ANCOVA|||||||0.259
71151358|NCT04040933|141794749|OTHER|Change from Baseline in Erythema measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.451|||||||ANCOVA|||||||0.451
71151359|NCT04040933|141794750|OTHER|Change from Baseline in Edema measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.|||||>|0.999|TWO_SIDED||||||ANCOVA|||||||>0.999
71151360|NCT04040933|141794750|OTHER|Change from Baseline in Edema measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.739|||||||ANCOVA|||||||0.739
71151361|NCT04040933|141794751|OTHER|Change from Baseline in Composite Scar Score Measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.|||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
71151362|NCT04040933|141794751|OTHER|Change from Baseline in Composite Scar Score Measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.053|||||||ANCOVA|||||||0.053
71151363|NCT04040933|141794752|OTHER|Change in Baseline in Painful Score with Arm Resting by Side was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.666|TWO_SIDED||||||ANCOVA|||||||0.666
71151364|NCT04040933|141794752|OTHER|Change in Baseline in Painful Score with Arm Resting by Side was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.473|||||||ANCOVA|||||||0.473
71151365|NCT04040933|141794753|OTHER|Change from Baseline In Painful Score with Arm in Normal Motion was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.761|TWO_SIDED||||||ANCOVA|||||||0.761
71151366|NCT04040933|141794753|OTHER|Change from Baseline In Painful Score with Arm in Normal Motion was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.456|||||||ANCOVA|||||||0.456
71151367|NCT04040933|141794754|OTHER|Change from Baseline In Itchy Score was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.019|TWO_SIDED||||||ANCOVA|||||||0.019
71151368|NCT04040933|141794754|OTHER|Change from Baseline In Itchy Score was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.325|||||||ANCOVA|||||||0.325
71151369|NCT04040933|141794755|OTHER|Time to complete healing was analyzed using a survival analysis method. The survival function (cumulative percentage of wounds healed at each time point) was estimated by the Kaplan-Meier method for each treatment separately. The median time to complete healing was derived from the estimated survival functions and be compared using the bootstrap re-sampling method.|||||<|0.001|TWO_SIDED|||||no adjustments|Boot-strap sampling method|||All hypothesis tests was conducted at 0.05 level without adjustment of multiple comparisons||||<0.001
71151370|NCT04040933|141794755|OTHER|Time to complete healing was analyzed using a survival analysis method. The survival function (cumulative percentage of wounds healed at each time point) was estimated by the Kaplan-Meier method for each treatment separately. The median time to complete healing was derived from the estimated survival functions and be compared using the bootstrap re-sampling method.|||||<|0.001||||||no adjustments|Boot-strap sampling method|||||||<0.001
71151371|NCT02653417|141794758|SUPERIORITY||Mean Difference (Final Values)|-0.18|||||TWO_SIDED|||||||||Regimen 1 = 5 mg vs Regimen 4 = placebo||||
71151372|NCT02653417|141794758|SUPERIORITY||Mean Difference (Final Values)|0.08|||||TWO_SIDED|||||||||Regimen 2 = 10 mg vs Regimen 4 = placebo||||
70956769|NCT02842151|141416885|EQUIVALENCE|Difference in A-Constant is manifest refraction minus autorefraction. The criteria for equivalence (based on paired difference t-test) was established if the bounds of the 90% two-sided confidence interval (CI) on the difference was contained within the equivalence range (-0.15, 0.15).|Mean Difference (Net)|-0.07|STANDARD_DEVIATION|0.595|||TWO_SIDED|90.0|-0.21|0.07||||||To demonstrate equivalency at Site 2, A-constant with manifest refraction was compared to A-constant with autorefraction.||0.07|-0.21|
71151373|NCT02653417|141794758|SUPERIORITY||Mean Difference (Final Values)|0.46|||||TWO_SIDED|||||||||Regimen 3 = 20 mg vs Regimen 4 = placebo||||
71151374|NCT01821118|141794808|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.984|STANDARD_ERROR_OF_MEAN|0.112|||TWO_SIDED|90.0|0.82|1.184|||||SE of mean is presented in log e scale.|ROI1: Analysis of the change from baseline in log(slope) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(slope) at baseline was included as a covariate.||1.184|0.820|
71151375|NCT01821118|141794808|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.934|STANDARD_ERROR_OF_MEAN|0.075|||TWO_SIDED|90.0|0.825|1.056|||||SE of mean is presented in log e scale.|ROI2: Analysis of the change from baseline in log(slope) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(slope) at baseline was included as a covariate.||1.056|0.825|
71151376|NCT01821118|141794809|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.852|STANDARD_ERROR_OF_MEAN|0.091|||TWO_SIDED|90.0|0.735|0.989|||||SE of mean is presented on log e scale.|ROI1: Analysis of the change from baseline in log(slope) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(slope) at baseline was included as a covariate.||0.989|0.735|
71151377|NCT01821118|141794809|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.902|STANDARD_ERROR_OF_MEAN|0.082|||TWO_SIDED|90.0|0.788|1.031|||||SE of mean presented on log e scale.|ROI2: Analysis of the change from baseline in log(slope) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(slope) at baseline was included as a covariate.||1.031|0.788|
71151378|NCT01821118|141794810|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.005|STANDARD_ERROR_OF_MEAN|0.046|||TWO_SIDED|90.0|0.933|1.086|||||SE of mean presented on log e scale.|ROI1, Day 2: Analysis of the change from baseline in log(time to peak) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to peak) at baseline was included as a covariate.||1.086|0.933|
71151379|NCT01821118|141794810|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.049|STANDARD_ERROR_OF_MEAN|0.036|||TWO_SIDED|90.0|0.99|1.114|||||SE of mean presented on log e scale.|ROI1, Day 90: Analysis of the change from baseline in log(time to peak) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to peak) at baseline was included as a covariate.||1.114|0.990|
71151380|NCT01821118|141794810|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.998|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|90.0|0.947|1.052|||||SE of mean presented on log e scale.|ROI2, Day 2: Analysis of the change from baseline in log(time to peak) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to peak) at baseline was included as a covariate.||1.052|0.947|
71151381|NCT01821118|141794810|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.01|STANDARD_ERROR_OF_MEAN|0.031|||TWO_SIDED|90.0|0.96|1.063|||||SE of mean presented on log e scale.|ROI2, Day 90: Analysis of the change from baseline in log(time to peak) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to peak) at baseline was included as a covariate.||1.063|0.960|
71151382|NCT01821118|141794811|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|0.0602|STANDARD_ERROR_OF_MEAN|0.1281|||TWO_SIDED|90.0|-0.1576|0.2781||||||ROI1, Day 2: Analysis of the change from baseline in log(amplitude) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(amplitude) at baseline was included as a covariate.||0.2781|-0.1576|
71151383|NCT01821118|141794811|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|-0.0859|STANDARD_ERROR_OF_MEAN|0.1165|||TWO_SIDED|90.0|-0.2843|0.1124||||||ROI1, Day 90: Analysis of the change from baseline in log(amplitude) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(amplitude) at baseline was included as a covariate.||0.1124|-0.2843|
71151384|NCT01821118|141794811|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|-0.0488|STANDARD_ERROR_OF_MEAN|0.0902|||TWO_SIDED|90.0|-0.2018|0.1042||||||ROI2, Day 2: Analysis of the change from baseline in log(amplitude) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(amplitude) at baseline was included as a covariate.||0.1042|-0.2018|
71151385|NCT01821118|141794811|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|-0.0888|STANDARD_ERROR_OF_MEAN|0.1061|||TWO_SIDED|90.0|-0.2689|0.0914||||||ROI2, Day 90: Analysis of the change from baseline in log(amplitude) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(amplitude) at baseline was included as a covariate.||0.0914|-0.2689|
70956770|NCT02842151|141416885|EQUIVALENCE|Difference in A-Constant is manifest refraction minus autorefraction. The criteria for equivalence (based on paired difference t-test) was established if the bounds of the 90% two-sided confidence interval (CI) on the difference was contained within the equivalence range (-0.15, 0.15).|Mean Difference (Net)|-0.13|STANDARD_DEVIATION|0.34|||TWO_SIDED|90.0|-0.22|-0.04||||||To demonstrate equivalency at Site 3, A-constant with manifest refraction was compared to A-constant with autorefraction.||-0.04|-0.22|
70956771|NCT02559895|141416897|SUPERIORITY||Mean Difference (Final Values)|-1.11|STANDARD_DEVIATION|3.4||0.0001|TWO_SIDED|95.0|-1.68|-0.54|||ANCOVA|||||-0.54|-1.68|0.0001
71151386|NCT01821118|141794812|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|0.0464|STANDARD_ERROR_OF_MEAN|0.0395|||TWO_SIDED|90.0|-0.0207|0.1136||||||ROI1, Day 2: Analysis of the change from baseline in log(time to return to baseline) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to return to baseline) at baseline was included as a covariate.||0.1136|-0.0207|
70956772|NCT02559895|141416897|SUPERIORITY||Mean Difference (Final Values)|-0.69|STANDARD_DEVIATION|3.4||0.0182|TWO_SIDED|95.0|-1.25|-0.12|||ANCOVA|||||-0.12|-1.25|0.0182
70956773|NCT02559895|141416897|SUPERIORITY||Mean Difference (Final Values)|-0.82|STANDARD_DEVIATION|3.4||0.0046|TWO_SIDED|95.0|-1.39|-0.25|||ANCOVA|||||-0.25|-1.39|0.0046
70956774|NCT02559895|141416898|SUPERIORITY||Mean Difference (Final Values)|13.5||||0.0007|TWO_SIDED|95.0|5.8|21.2|||Cochran-Mantel-Haenszel|||||21.2|5.8|0.0007
70956775|NCT02559895|141416898|SUPERIORITY||Mean Difference (Final Values)|6.0||||0.1126|TWO_SIDED|95.0|-1.4|13.3|||Cochran-Mantel-Haenszel|||||13.3|-1.4|0.1126
71151387|NCT01821118|141794812|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|0.0737|STANDARD_ERROR_OF_MEAN|0.0383|||TWO_SIDED|90.0|0.0084|0.139||||||ROI1, Day 90: Analysis of the change from baseline in log(time to return to baseline) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to return to baseline) at baseline was included as a covariate.||0.1390|0.0084|
71151388|NCT01821118|141794812|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|0.0219|STANDARD_ERROR_OF_MEAN|0.0337|||TWO_SIDED|90.0|-0.0352|0.079||||||ROI2, Day 2: Analysis of the change from baseline in log(time to return to baseline) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to return to baseline) at baseline was included as a covariate.||0.0790|-0.0352|
71151389|NCT01821118|141794812|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|0.0117|STANDARD_ERROR_OF_MEAN|0.034|||TWO_SIDED|90.0|-0.046|0.0694||||||ROI2, Day 90: Analysis of the change from baseline in log(time to return to baseline) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to return to baseline) at baseline was included as a covariate.||0.0694|-0.0460|
71151390|NCT00643162|141794885|OTHER||Mean Difference (Final Values)|2.3|STANDARD_DEVIATION|6.15||0.68|TWO_SIDED||||||t-test, 2 sided|||||||.68
71151391|NCT02284243|141794888|SUPERIORITY_OR_OTHER|||||||0.018|||||||ANCOVA|||||||0.0180
71151392|NCT02284243|141794889|SUPERIORITY_OR_OTHER||||||<|0.05||||||Applies to SPID 0-6, SPID 0-12, and SPID 0-24|ANCOVA|||||||<0.05
71151393|NCT02284243|141794890|SUPERIORITY_OR_OTHER||||||<|0.05||||||Applies to perceptible and meaningful pain relief|Log Rank|||||||<0.05
70956776|NCT02559895|141416898|SUPERIORITY||Mean Difference (Final Values)|8.4||||0.0272|TWO_SIDED|95.0|1.0|15.9|||Cochran-Mantel-Haenszel|||||15.9|1.0|0.0272
71151394|NCT02284243|141794891|SUPERIORITY_OR_OTHER||||||<|0.05||||||Applies to ≥30% and ≥50% reduction in pain|Cochran-Mantel-Haenszel|Test for general association stratified by site||||||<0.05
71151395|NCT02284243|141794893|SUPERIORITY_OR_OTHER|||||||0.0009|||||||Log Rank|||||||0.0009
70876342|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.59||||0.0037|TWO_SIDED|95.0|-1.0|-0.2|||Mixed Model Repeated Measures ANCOVA|||Week 7: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.2|-1.0|0.0037
70876343|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.27|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.9|||Mixed Model Repeated Measures ANCOVA|||Week 8: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.9|-1.7|<.0001
70956777|NCT02559895|141416899|SUPERIORITY||Mean Difference (Final Values)|11.3||||0.0066|TWO_SIDED|95.0|3.2|19.3|||Cochran-Mantel-Haenszel|||||19.3|3.2|0.0066
70956778|NCT02559895|141416899|SUPERIORITY||Mean Difference (Final Values)|10.5||||0.0112|TWO_SIDED|95.0|2.4|18.6|||Cochran-Mantel-Haenszel|||||18.6|2.4|0.0112
70956779|NCT02559895|141416899|SUPERIORITY||Mean Difference (Final Values)|9.8||||0.017|TWO_SIDED|95.0|1.8|17.8|||Cochran-Mantel-Haenszel|||||17.8|1.8|0.0170
70956780|NCT02559895|141416900|SUPERIORITY||Mean Difference (Final Values)|18.9||||0.0001|TWO_SIDED|95.0|9.8|28.0|||Cochran-Mantel-Haenszel|||||28.0|9.8|0.0001
70956781|NCT02559895|141416900|SUPERIORITY||Mean Difference (Final Values)|12.4||||0.0085|TWO_SIDED|95.0|3.2|21.5|||Cochran-Mantel-Haenszel|||||21.5|3.2|0.0085
70956782|NCT02559895|141416900|SUPERIORITY||Mean Difference (Final Values)|12.8||||0.0064|TWO_SIDED|95.0|3.7|22.0|||Cochran-Mantel-Haenszel|||||22.0|3.7|0.0064
71151396|NCT02284243|141794894|SUPERIORITY_OR_OTHER|||||||0.7718|||||||Cochran-Mantel-Haenszel|||||||0.7718
71151397|NCT02721966|141794923|SUPERIORITY||Odds Ratio (OR)|4.37|||<|0.0001|TWO_SIDED|95.0|2.72|7.01|||Regression, Logistic|95% confidence interval for odds ratio||"Up to week 12, all participants in the group placebo AIN457 took placebo only"||7.01|2.72|<.0001
70876344|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.97|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.6|||Mixed Model Repeated Measures ANCOVA|||Week 8: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.6|-1.4|<.0001
70956783|NCT02559895|141416901|SUPERIORITY|||||||0.0159|||||||Cochran-Mantel-Haenszel|||||||0.0159
70956784|NCT02559895|141416901|SUPERIORITY|||||||0.0312|||||||Cochran-Mantel-Haenszel|||||||0.0312
70956785|NCT02559895|141416901|SUPERIORITY|||||||0.1539|||||||Cochran-Mantel-Haenszel|||||||0.1539
70956786|NCT00589121|141416951|SUPERIORITY_OR_OTHER|The fixed rate of 37% comes from the published National Cancer Institute of Canada trial SR2 (CAN-NCIC-SR2: Phase III Randomized Study of Pre- vs Postoperative Radiotherapy in Curable Extremity Soft Tissue Sarcoma) receiving preoperative radiation therapy without image-guided radiation therapy (IGRT).||||||0.0005|||||||Fisher Exact|||Initially designed to test for a 20% absolute improvement from 37% (fixed rate) to 17% using Fisher's exact test, requiring 41 patients per cohort (51 with 20% ineligibility) with 5% type I error and 90% statistical power. During accrual, the sample size for cohort B was increased to 66 (83 with 20% ineligibility) to test for a 15% improvement with 5% type I error and 85% power.||||0.0005
70956787|NCT02317432|141416972|SUPERIORITY||Slope|-0.12|||<|0.01|TWO_SIDED|||||Threshold for statistical significance was p\<0.05|Mixed Models Analysis|||||||<0.01
70956788|NCT02317432|141416973|SUPERIORITY||Slope|0.6||||0.03|TWO_SIDED|||||Threshold for statistical significance was p\<0.05|Mixed Models Analysis|||||||0.03
70956789|NCT02317432|141416974|SUPERIORITY||Slope|6.0||||0.02|TWO_SIDED|||||Threshold for statistical significance was p\<0.05|Mixed Models Analysis|||||||0.02
70956790|NCT02317432|141416975|SUPERIORITY||Slope|-1.24||||0.15|TWO_SIDED|||||Threshold for statistical significance was p\<0.05|Mixed Models Analysis|||||||0.15
70956791|NCT02317432|141416976|SUPERIORITY||Slope|-0.49||||0.35|TWO_SIDED|||||Threshold for statistical significance was p\<0.05|Mixed Models Analysis|||||||0.35
70956792|NCT03992846|141416980|OTHER|The criterion for defining a subject as a responder over the last 28 days of randomized treatment up to Month 3 was a reduction of 1.10 or greater from baseline pain for Dysmenorrhea (DYS).|Odds Ratio (OR)|2.56|||<|0.001|TWO_SIDED|97.5|1.46|4.49|||Bonferroni-corrected p-value|||||4.49|1.46|<0.001
70956793|NCT03992846|141416980|OTHER|The criterion for defining a subject as a responder over the last 28 days of randomized treatment up to Month 3 was a reduction of 1.10 or greater from baseline pain for Dysmenorrhea (DYS).|Odds Ratio (OR)|8.8|||<|0.001|TWO_SIDED|97.5|4.86|15.91|||Bonferroni-corrected p-value|||||15.91|4.86|<0.001
70956794|NCT03992846|141416981|OTHER|The criterion for defining a subject as a responder over the last 28 days of randomized treatment up to Month 3 was a reduction of 0.80 or greater from baseline pain for Non-Menstrual Pelvic Pain (NMPP).|Odds Ratio (OR)|1.43||||0.279|TWO_SIDED|97.5|0.83|2.45|||Bonferroni-corrected p-value|||||2.45|0.83|0.279
70956795|NCT03992846|141416981|OTHER|The criterion for defining a subject as a responder over the last 28 days of randomized treatment up to Month 3 was a reduction of 0.80 or greater from baseline pain for Non-Menstrual Pelvic Pain (NMPP).|Odds Ratio (OR)|2.01||||0.007|TWO_SIDED|97.5|1.18|3.42|||Bonferroni-corrected p-value|||||3.42|1.18|0.007
71151398|NCT02721966|141794923|SUPERIORITY||Odds Ratio (OR)|3.83|||<|0.0001|TWO_SIDED|95.0|2.41|6.1|||Regression, Logistic|95% confidence interval for odds ratio||"Up to week 12, all participants in the group placebo AIN457 took placebo only"||6.10|2.41|<.0001
71151399|NCT02721966|141794924|SUPERIORITY||Odds Ratio (OR)|4.37|||<|0.0001|TWO_SIDED|95.0|2.72|7.01|||Regression, Logistic|95% confidence interval for odds ratio||"Up to week 12, all participants in the group placebo AIN457 took placebo only"||7.01|2.72|<.0001
71151400|NCT02721966|141794925|SUPERIORITY||Odds Ratio (OR)|4.71|||<|0.0001|TWO_SIDED|95.0|2.67|8.33|||Regression, Logistic|95% confidence interval for odds ratio|||Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables|8.33|2.67|<.0001
70956796|NCT00775463|141417013|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|0.0||||0.2|TWO_SIDED|95.0|-1.0|0.0|||Cochran-Mantel-Haenszel|||A Cochran-Mantel Haenszel mean score test was used on the standardized reverse mid-ranks (overall reverse ranks divided by the number of ranks +1, or modified ridit scores; largely negative changes had ranks near 1 and largely positive changes had ranks near 0)of the residuals from an ordinary least squares regression with change in net ulcer burden at Week 20 as a linear function of Baseline PDEI or prostacyclin use (binary variable:Yes/No) and net ulcer burden at Baseline(continuous variable).||0.0|-1.0|0.20
70956797|NCT00775463|141417014|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|-0.4||||0.31|TWO_SIDED|95.0|-1.4|0.4||Analyses of secondary endpoints were descriptive in nature, no adjustments for multiplicity were made. P-values are for the purpose of describing the random imbalance between treatment groups and not to test formal hypotheses.|Wilcoxon (Mann-Whitney)|||The difference between treatment groups for the change from Baseline was tested using the Wilcoxon rank-sum test.||0.40|-1.40|0.31
70956798|NCT00775463|141417015|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|-9.3||||0.12|TWO_SIDED|95.0|-21.3|2.7||Analyses of secondary endpoints were descriptive in nature, no adjustments for multiplicity were made. P-values are for the purpose of describing the random imbalance between treatment groups and not to test formal hypotheses.|Wilcoxon (Mann-Whitney)|||The VAS-global assessments were recorded in centimeters, with possible values ranging from 0.0 to 15.0. The recorded value was divided by 15, then multiplied by 100 to convert it to the VAS-Global scale, with values ranging from 0 (no disease activity) to 100 (very severe disease). The difference between treatment groups for the change from Baseline was tested using the Wilcoxon rank-sum test.||2.7|-21.3|0.12
70956799|NCT00775463|141417016|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|-9.3||||0.04|TWO_SIDED|95.0|-18.0|0.0||Analyses of secondary endpoints were descriptive in nature, no adjustments for multiplicity were made. P-values are for the purpose of describing the random imbalance between treatment groups and not to test formal hypotheses.|Wilcoxon (Mann-Whitney)|||The VAS-global assessments were recorded in centimeters, with possible values ranging from 0.0 to 15.0. The recorded value was divided by 15, then multiplied by 100 to convert it to the VAS-Global scale, with values ranging from 0 (no disease activity) to 100 (very severe disease). The difference between treatment groups for the change from Baseline was tested using the Wilcoxon rank-sum test.||0.0|-18.0|0.04
70956800|NCT00775463|141417017|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|-1.0||||0.47|TWO_SIDED|95.0|-4.0|2.0||Analyses of secondary endpoints were descriptive in nature, no adjustments for multiplicity were made. P-values are for the purpose of describing the random imbalance between treatment groups and not to test formal hypotheses.|Wilcoxon (Mann-Whitney)|||The difference between treatment groups for the change from Baseline in CHFS Score were tested using the Wilcoxon rank-sum test.||2.0|-4.0|0.47
70956801|NCT00775463|141417019|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|0.0||||0.68|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||he difference between treatment groups for the change from Baseline and at Week 20 in the mRSS was tested using the Wilcoxon rank-sum test.||1.0|0.0|0.68
70956802|NCT00775463|141417020|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|-1.0||||0.54|TWO_SIDED|95.0|-3.0|2.0||P value for Total Pain Rating Index Score|Wilcoxon (Mann-Whitney)|||P value for Total Pain Rating Index Score||2.0|-3.0|0.54
70956803|NCT00775463|141417020|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Ef|-0.6||||0.18|TWO_SIDED|95.0|-1.6|0.3||P value for Pain VAS|Wilcoxon (Mann-Whitney)|||P value for Pain VAS||0.3|-1.6|0.18
70956804|NCT00775463|141417020|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|0.0||||0.1|TWO_SIDED|95.0|-1.0|0.0||P value for Total Pain Rating Index Score|Wilcoxon (Mann-Whitney)|||P value for Total Pain Rating Index Score||0.0|-1.0|0.10
70956805|NCT00452426|141417035|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED||||||ANOVA|||||||0.028
70956806|NCT00452426|141417037|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||ANOVA|||||||0.007
70956807|NCT00452426|141417038|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
70956808|NCT00091169|141417044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.57|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.57
70956809|NCT00091169|141417045|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.64
70956810|NCT00091169|141417046|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.93
70956811|NCT00091169|141417047|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.61
71151401|NCT02721966|141794925|SUPERIORITY||Odds Ratio (OR)|5.61|||<|0.0001|TWO_SIDED|95.0|3.2|9.84|||Regression, Logistic|95% confidence interval for odds ratio|||Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables|9.84|3.20|<.0001
70956812|NCT00091169|141417048|SUPERIORITY_OR_OTHER_LEGACY|||||||1e-05|TWO_SIDED||||||Fisher Exact|||||||0.00001
70956813|NCT00091169|141417049|SUPERIORITY_OR_OTHER_LEGACY|||||||0.677|TWO_SIDED||||||Fisher Exact|||||||0.677
70956814|NCT00872989|141417050|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.49|TWO_SIDED|80.0|0.79|1.26|||Regression, Cox|||||1.26|0.79|0.49
71151402|NCT02721966|141794926|SUPERIORITY||Odds Ratio (OR)|4.5|||<|0.0001|TWO_SIDED|95.0|2.43|8.33|||Regression, Logistic|95% confidence interval for odds ratio||"Up to week 12, all participants in the group placebo AIN457 took placebo only"|Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables|8.33|2.43|<.0001
70956815|NCT00872989|141417052|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.83|TWO_SIDED|80.0|0.93|1.68|||Regression, Cox|||||1.68|0.93|0.83
70956816|NCT02233543|141417111|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.2419|TWO_SIDED|95.0|-1.21|0.32|||Mixed Models Analysis|||||0.32|-1.21|0.2419
70956817|NCT02233543|141417112|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.79||||0.2016|TWO_SIDED|95.0|-4.51|20.08|||Mixed Models Analysis|||||20.08|-4.51|0.2016
71151403|NCT02721966|141794926|SUPERIORITY||Odds Ratio (OR)|5.57|||<|0.0001|TWO_SIDED|95.0|3.04|10.21|||Regression, Logistic|95% confidence interval for odds ratio||"Up to week 12, all participants in the group placebo AIN457 took placebo only"|Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables|10.21|3.04|<.0001
71151404|NCT02721966|141794927|SUPERIORITY||LS Mean of Treatment Difference|-14.9|STANDARD_ERROR_OF_MEAN|2.62|<|0.0001|TWO_SIDED|95.0|-20.0|-9.7|||ANCOVA||||Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline measurement in VAS as continuous covariate|-9.7|-20.0|<.0001
71151405|NCT02721966|141794927|SUPERIORITY||LS Mean of Treatment Difference|-12.9|STANDARD_ERROR_OF_MEAN|2.59|<|0.0001|TWO_SIDED|95.0|-18.0|-7.8|||ANCOVA||||Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline measurement in VAS as continuous covariate|-7.8|-18.0|<.0001
71151406|NCT02721966|141794928|SUPERIORITY||LS Mean of Treatment Difference|-15.1|STANDARD_ERROR_OF_MEAN|2.71|<|0.0001|TWO_SIDED|95.0|-20.4|-9.7|||ANCOVA|||"Up to week 12, all participants in the group placebo AIN457 took placebo only"|Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline measurement in VAS as continuous covariate|-9.7|-20.4|<.0001
71151407|NCT02721966|141794928|SUPERIORITY||LS Mean of Treatment Difference|-15.0|STANDARD_ERROR_OF_MEAN|2.68|<|0.0001|TWO_SIDED|95.0|-20.3|-9.8|||ANCOVA|||"Up to week 12, all participants in the group placebo AIN457 took placebo only"|Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline measurement in VAS as continuous covariate|-9.8|-20.3|<.0001
71151408|NCT02721966|141794929|SUPERIORITY||LS Mean of Treatment Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.0971|TWO_SIDED|95.0|-1.1|0.1|||ANCOVA||||Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline SPARCC index as continuous covariate.|0.1|-1.1|0.0971
71151409|NCT02721966|141794929|SUPERIORITY||LS Mean of Treatment Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0207|TWO_SIDED|95.0|-1.3|-0.1|||ANCOVA||||Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline measurement in VAS as continuous covariate|-0.1|-1.3|0.0207
71151410|NCT02721966|141794930|SUPERIORITY||LS Mean of Treatment Difference|-0.175|STANDARD_ERROR_OF_MEAN|0.0502||0.0005|TWO_SIDED|95.0|-0.273|-0.076|||ANCOVA||||Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline HAQ-DI index as continuous covariate|-0.076|-0.273|0.0005
71151411|NCT02721966|141794930|SUPERIORITY||LS Mean of Treatment Difference|-0.234|STANDARD_ERROR_OF_MEAN|0.0497|<|0.0001|TWO_SIDED|95.0|-0.331|-0.136|||ANCOVA||||Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline HAQ-DI index as continuous covariate|-0.136|-0.331|<.0001
71151412|NCT02721966|141794931|SUPERIORITY||LS Mean of Treatment Difference|3.8|STANDARD_ERROR_OF_MEAN|1.01||0.0002|TWO_SIDED|95.0|1.8|5.7|||ANCOVA|||week 12|Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline FACIT Fatigue© score as continuous covariate|5.7|1.8|0.0002
71151413|NCT02721966|141794931|SUPERIORITY||LS Mean of Treatment Difference|3.4|STANDARD_ERROR_OF_MEAN|0.99||0.0007|TWO_SIDED|95.0|1.4|5.3|||ANCOVA|||week 12|Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline FACIT Fatigue© score as continuous covariate|5.3|1.4|0.0007
71151414|NCT02721966|141794932|SUPERIORITY||LS Mean of Treatment Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.41|<|0.0001|TWO_SIDED|95.0|-2.5|-0.9|||ANCOVA|||"Up to week 12, all participants in the group placebo AIN457 took placebo only"|Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group,visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline ASAS health index as continuous covariate.|-0.9|-2.5|<.0001
71151415|NCT02721966|141794932|SUPERIORITY||LS Mean of Treatment Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-2.4|-0.9|||ANCOVA|||"Up to week 12, all participants in the group placebo AIN457 took placebo only"|Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group,visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline ASAS health index as continuous covariate.|-0.9|-2.4|<.0001
70876345|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61||||0.0031|TWO_SIDED|95.0|-1.0|-0.2|||Mixed Model Repeated Measures ANCOVA|||Week 8: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.2|-1.0|0.0031
71151416|NCT02721966|141794933|SUPERIORITY||Odds Ratio (OR)|5.74|||<|0.0001|TWO_SIDED|95.0|3.31|9.95|||Regression, Logistic|95% confidence interval for odds ratio|||"Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables.~Missing ACR20 response variables were imputed by multiple imputation approach"|9.95|3.31|<.0001
71151417|NCT02721966|141794933|SUPERIORITY||Odds Ratio (OR)|4.8|||<|0.0001|TWO_SIDED|95.0|2.83|8.16|||Regression, Logistic|95% confidence interval for odds ratio|||"Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables.~Missing ACR20 response variables were imputed by multiple imputation approach"|8.16|2.83|<.0001
71151418|NCT02157883|141794937|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Upper bound of the 90% CIs below 200%.|Geometric mean ratio|79.87|||||TWO_SIDED|90.0|73.15|87.21|||||AZD9291+itraconazole / AZD9291 alone. Results based on linear mixed-effects model with treatment as fixed effect and patient as a random effect.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.||87.21|73.15|
71151419|NCT02157883|141794938|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Upper bound of the 90% CIs below 200%.|Geometric mean ratio|124.17|||||TWO_SIDED|90.0|114.61|134.53|||||AZD9291+itraconazole / AZD9291 alone. Results based on linear mixed-effects model with treatment as fixed effect and patient as a random effect.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.||134.53|114.61|
71151420|NCT02157883|141794945|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|75.87|||||TWO_SIDED|90.0|64.18|89.69|||||AZD9291+itraconazole / AZD9291 alone. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.||89.69|64.18|
71151421|NCT02157883|141794946|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|108.25|||||TWO_SIDED|90.0|94.36|124.19|||||AZD9291+itraconazole / AZD9291 alone. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.||124.19|94.36|
71151422|NCT02157883|141794947|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|44.33|||||TWO_SIDED|90.0|39.94|49.21|||||AZD9291+itraconazole / AZD9291 alone. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.||49.21|39.94|
71151423|NCT02157883|141794948|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|49.02|||||TWO_SIDED|90.0|43.7|54.99|||||AZD9291+itraconazole / AZD9291 alone. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.||54.99|43.70|
70876346|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.12|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.7|||Mixed Model Repeated Measures ANCOVA|||Week 9: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.7|-1.5|<.0001
71151424|NCT00888940|141794949|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.001
71151425|NCT00607373|141794951|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p≤0.05|t-test, 2 sided|||Based upon prior clinical study experience with mipomersen, it was estimated that the standard deviation of the percent change in LDL-C is approximately 22%. With 15 patients in the control group and 30 patients in the mipomersen-treated group, this study would have at least 80% power to detect a 20 percentage point difference between the 2 treatment groups. Fifty-one patients were enrolled to allow for patient withdrawals and potential exclusions from analysis sets.||||<0.001
71151426|NCT00607373|141794952|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
71151427|NCT00607373|141794954|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inferential conclusions about this parameter require statistical significance of the previous secondary outcome measure (i.e., percent change from baseline in Apo B at PET).|t-test, 2 sided|||||||<0.001
71151428|NCT00607373|141794957|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inferential conclusions about this parameter require statistical significance of the previous secondary outcome measure (i.e., percent change from baseline in total cholesterol at PET).|t-test, 2 sided|||||||<0.001
71151429|NCT00607373|141794959|SUPERIORITY_OR_OTHER|||||||0.013||||||Statistical significance was concluded if p ≤0.05|Wilcoxon rank sum test|||||||0.013
71151430|NCT00607373|141794961|SUPERIORITY_OR_OTHER|||||||0.001||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||0.001
71151431|NCT00607373|141794963|SUPERIORITY_OR_OTHER|||||||0.009||||||Statistical significance was concluded if p ≤0.05|Wilcoxon rank sum test|||||||0.009
71151432|NCT00607373|141794965|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||<0.001
71151433|NCT00607373|141794967|SUPERIORITY_OR_OTHER|||||||0.328||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||0.328
71151434|NCT00607373|141794969|SUPERIORITY_OR_OTHER|||||||0.035||||||Statistical significance was concluded if p ≤0.05|Wilcoxon rank sum test|||||||0.035
71151435|NCT01724346|141794980|SUPERIORITY||Hazard Ratio (HR)|0.155|||<|0.0001|TWO_SIDED|95.0|0.11|0.22||P-value is from stratified log-rank test.|Log Rank|||||0.220|0.110|< 0.0001
70876347|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.83|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 9: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.2|<.0001
70876348|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.53||||0.0117|TWO_SIDED|95.0|-0.9|-0.1|||Mixed Model Repeated Measures ANCOVA|||Week 9: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.1|-0.9|0.0117
70956818|NCT03573583|141417113|SUPERIORITY||Mean Difference (Final Values)|2.29||||0.03|TWO_SIDED|95.0|0.22|4.36||No formal adjustment for type I error due to the pilot nature of the study. All significance tests were 2-tailed and an alpha level of 0.05 was required for significance.|ANCOVA|Adjusted for baseline score.||Continuous variables were expressed as mean (SD) and categorical variables were as frequencies and percentages. A 2-sided independent-sample t test was used to compare group differences in change scores. Change scores were calculated as Week 16 measurements minus baseline measurements. Statistical analyses were done by a blinded statistician without knowledge of group membership.||4.36|0.22|0.03
70956819|NCT03573583|141417114|SUPERIORITY||Mean Difference (Final Values)|1.04||||0.009|TWO_SIDED|95.0|0.31|1.77|||ANCOVA|Adjusted for baseline score.||||1.77|0.31|0.009
70956820|NCT03573583|141417115|SUPERIORITY||Mean Difference (Final Values)|1.29||||0.07|TWO_SIDED|95.0|-0.1|2.67|||ANCOVA|Baseline as covariate||||2.67|-0.10|0.07
70956821|NCT03573583|141417116|OTHER|Pearson's correlation coefficients, along with their 95% confidence intervals (CIs)|Pearson's Correlation coefficient|0.19||||0.49|TWO_SIDED|95.0|-0.35|0.64|||Pearson's Correlation coefficient|||||0.64|-0.35|0.49
70956822|NCT03730480|141417121|OTHER|count of number of results within 15% of reference analyzer||||||||||||||||count of number of responses|The number of results that are within 15% of reference analyzer is reported.|||
70956823|NCT00852540|141417132|SUPERIORITY_OR_OTHER||percentage of participants|56.9|||||TWO_SIDED|95.0|45.5|68.4|||||The estimated value is the percentage of participants achieving clinical response. Confidence intervals are not adjusted for multiplicity.|||68.4|45.5|
70956824|NCT00852540|141417132|SUPERIORITY_OR_OTHER||Percentage of participants|84.2|||||TWO_SIDED|95.0|72.6|95.8|||||The estimated value is the percentage of participants achieving clinical response. Confidence intervals are not adjusted for multiplicity.|||95.8|72.6|
70956825|NCT01639495|141417143|SUPERIORITY_OR_OTHER||Percentage of subjects|60.6|||||TWO_SIDED|95.0|51.9|68.8|||||The 2-sided 95% confidence intervals are based on exact binomial|||68.8|51.9|
70956826|NCT01639495|141417145|SUPERIORITY_OR_OTHER||Percentage of subjects with primary AEs|17.4|||||TWO_SIDED|95.0|11.6|24.6|||||The 2-sided 95% confidence interval is exact binomial|||24.6|11.6|
70956827|NCT01639495|141417146|SUPERIORITY_OR_OTHER||Percentage of subjects|97.2|||||TWO_SIDED|95.0|95.6|98.2|||||The 2-sided 95% confidence intervals are exact binomial|||98.2|95.6|
71151436|NCT01724346|141794983|SUPERIORITY||Hazard Ratio (HR)|0.087|||<|0.0001|TWO_SIDED|95.0|0.054|0.141||P value is from stratified log-rank test.|Log Rank|||||0.141|0.054|< 0.0001
71151437|NCT01724346|141794984|SUPERIORITY||Rate ratio|2.496|||<|0.0001|TWO_SIDED|95.0|1.99|3.131||Rate ratio and p-value are based on Cochran-Mantel-Haenszel chi-square test stratified by Eastern Cooperative Oncology Group (ECOG; 0-1 vs 2) and Rai stage (0/I/II vs III/IV) at baseline.|Cochran-Mantel-Haenszel|||||3.131|1.990|< 0.0001
71151438|NCT02876601|141794987|SUPERIORITY|||||||0.408|||||||Wilcoxon (Mann-Whitney)|||||||0.408
71151439|NCT02876601|141794988|SUPERIORITY|||||||0.148|||||||Wilcoxon (Mann-Whitney)|||||||0.148
71151440|NCT02876601|141794989|SUPERIORITY|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
71151441|NCT02876601|141794990|SUPERIORITY|||||||0.642|||||||Wilcoxon (Mann-Whitney)|||||||0.642
71151442|NCT02876601|141794991|SUPERIORITY|||||||0.026|||||||Wilcoxon (Mann-Whitney)|||||||0.026
71151443|NCT02876601|141794992|SUPERIORITY|||||||0.326|||||||Wilcoxon (Mann-Whitney)|||||||0.326
71151444|NCT02876601|141794993|SUPERIORITY|||||||0.796|||||||Wilcoxon (Mann-Whitney)|||||||0.796
71151445|NCT02876601|141794994|SUPERIORITY|||||||0.918|||||||Wilcoxon (Mann-Whitney)|||||||0.918
71151446|NCT02876601|141794995|SUPERIORITY|||||||0.877|||||||Wilcoxon (Mann-Whitney)|||||||0.877
71151447|NCT02876601|141794996|SUPERIORITY|||||||0.423|||||||Wilcoxon (Mann-Whitney)|||||||0.423
71151448|NCT02876601|141794997|SUPERIORITY|||||||0.938|||||||Wilcoxon (Mann-Whitney)|||||||0.938
71151449|NCT00256997|141794998|SUPERIORITY_OR_OTHER|||||||0.5498||||||P-value was calculated by Cox proportional hazard model stratified for positive and negative symptom scale.|Cox proportional hazard model|||||||0.5498
71151450|NCT00354432|141795008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3455|TWO_SIDED|||||This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|A mixed effects repeated measures analysis of variance was used with the baseline means constrained to be equal in the four groups.||The null hypothesis was that there was no difference in the hot flash severity score at 12 weeks.||||.3455
71151451|NCT00354432|141795009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2081|TWO_SIDED|||||This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|||Null hypothesis was that there was no difference in quality of life between the four groups at 12 weeks.||||0.2081
71151452|NCT02819011|141795020|SUPERIORITY|||||||0.04||||||priori threshold for statistical significance= 0.05|Mixed Models Analysis|||Repeated measures to compare changes in two groups from baseline to 6 months||||0.040
70876349|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.8|||Mixed Model Repeated Measures ANCOVA|||Week 10: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.8|-1.6|<.0001
70876350|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 10: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.3|<.0001
70876351|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61||||0.004|TWO_SIDED|95.0|-1.0|-0.2|||Mixed Model Repeated Measures ANCOVA|||Week 10: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.2|-1.0|0.0040
70876352|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.7|||Mixed Model Repeated Measures ANCOVA|||Week 11: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.7|-1.6|<.0001
70876353|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.83|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 11: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.2|<.0001
70876354|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56||||0.01|TWO_SIDED|95.0|-1.0|-0.1|||Mixed Model Repeated Measures ANCOVA|||Week 11: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.1|-1.0|0.0100
70876355|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.07|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.6|||Mixed Model Repeated Measures ANCOVA|||Week 12: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.6|-1.5|<.0001
70876356|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.73||||0.0006|TWO_SIDED|95.0|-1.2|-0.3|||Mixed Model Repeated Measures ANCOVA|||Week 12: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.3|-1.2|0.0006
70876357|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4||||0.069|TWO_SIDED|95.0|-0.8|0.0|||Mixed Model Repeated Measures ANCOVA|||Week 12: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||0.0|-0.8|0.0690
70876358|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.21|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.8|||Mixed Model Repeated Measures ANCOVA|||Week 13: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.8|-1.6|<.0001
70876359|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.88|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 13: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.3|<.0001
70876360|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61||||0.0054|TWO_SIDED|95.0|-1.0|-0.2|||Mixed Model Repeated Measures ANCOVA|||Week 13: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.2|-1.0|0.0054
70876361|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.21|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.8|||Mixed Model Repeated Measures ANCOVA|||Week 14: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.8|-1.6|<.0001
70876362|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.87|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 14: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.3|<.0001
70876363|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.65||||0.0036|TWO_SIDED|95.0|-1.1|-0.2|||Mixed Model Repeated Measures ANCOVA|||Week 14: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.2|-1.1|0.0036
70876364|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.16|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.9|||Mixed Model Repeated Measures ANCOVA|||Overall: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.9|-1.5|<.0001
70876365|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.86|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.6|||Mixed Model Repeated Measures ANCOVA|||Overall: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.6|-1.1|<.0001
71151453|NCT02819011|141795021|SUPERIORITY|||||||0.005||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes in both groups from baseline to 6 months||||0.005
70956828|NCT01183234|141417148|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Point estimates and 90% confidence intervals for the ratio of the treatment regimen means were provided by back-transformation on to the linear scale and were assessed against the currently accepted bioequivalence criteria for log-transformed data (0.80, 1.25).|Ratio of geometric LS means|0.953|||||TWO_SIDED|90.0|0.915|0.993|||Mixed Models Analysis|||||0.993|0.915|
70956829|NCT01183234|141417149|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Point estimates and 90% confidence intervals for the ratio of the treatment regimen means were provided by back-transformation on to the linear scale and were assessed against the currently accepted bioequivalence criteria for log-transformed data (0.80, 1.25).|Ratio of geometric LS means|0.988|||||TWO_SIDED|90.0|0.931|1.05|||Mixed Models Analysis|||||1.05|0.931|
70956830|NCT01183234|141417150|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|-0.15|0.492|||Wilcoxon (Hodges-Lehmann)|||||0.492|-0.150|
70956831|NCT00704379|141417151|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.6|||<|0.05|TWO_SIDED|95.0|1.1|16.2|||Log Rank|||||16.2|1.1|<0.05
70956832|NCT01639560|141417157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.7|||<|0.001|TWO_SIDED|95.0|2.5|18.1|||Regression, Logistic|||||18.1|2.5|<0.001
70956833|NCT01639560|141417158|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.33||||0.001|TWO_SIDED|95.0|2.2|24.0|||Regression, Logistic|||||24.0|2.2|0.001
70956834|NCT01639560|141417159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.047|TWO_SIDED|95.0|1.0|6.3|||Regression, Logistic|||||6.3|1.0|0.047
70956835|NCT01639560|141417160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0||||0.009|TWO_SIDED|95.0|1.5|16.5|||Regression, Logistic|||||16.5|1.5|0.009
70956836|NCT01156792|141417184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026|||=|0.268|TWO_SIDED|95.0|-0.02|0.07|||Mixed Models Analysis|||||0.07|-0.02|=0.268
70956837|NCT01156792|141417184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|||=|0.08|TWO_SIDED|95.0|0.0|0.09|||Mixed Models Analysis|||||0.09|-0.00|=0.080
70956838|NCT01156792|141417184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056|||=|0.017|TWO_SIDED|95.0|0.01|0.1|||Mixed Models Analysis|||||0.10|0.01|=0.017
70956839|NCT01156792|141417184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.074|||=|0.002|TWO_SIDED|95.0|0.03|0.12|||Mixed Models Analysis|||||0.12|0.03|=0.002
70956840|NCT01156792|141417185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.946|||=|0.751|TWO_SIDED|95.0|-4.91|6.81|||Mixed Models Analysis|||||6.81|-4.91|=0.751
70876366|NCT00333866|141236653|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.66|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.4|||Mixed Model Repeated Measures ANCOVA|||Overall: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.0|<.0001
70956841|NCT01156792|141417185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.771|||=|0.049|TWO_SIDED|95.0|0.03|11.51|||Mixed Models Analysis|||||11.51|0.03|=0.049
70956842|NCT01156792|141417185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.983|||=|0.123|TWO_SIDED|95.0|-1.35|11.32|||Mixed Models Analysis|||||11.32|-1.35|=0.123
70956843|NCT01156792|141417185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.14|||<|0.001|TWO_SIDED|95.0|5.93|18.35|||Mixed Models Analysis|||||18.35|5.93|<0.001
70956844|NCT01156792|141417186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.651|||=|0.563|TWO_SIDED|95.0|-3.97|7.27|||Mixed Models Analysis|||||7.27|-3.97|=0.563
70956845|NCT01156792|141417186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|||=|0.072|TWO_SIDED|95.0|-0.47|10.67|||Mixed Models Analysis|||||10.67|-0.47|=0.072
70956846|NCT01156792|141417186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.822|||=|0.126|TWO_SIDED|95.0|-1.37|11.02|||Mixed Models Analysis|||||11.02|-1.37|=0.126
70956847|NCT01156792|141417186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.292|||=|0.001|TWO_SIDED|95.0|4.21|16.38|||Mixed Models Analysis|||||16.38|4.21|=0.001
70956848|NCT01156792|141417187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.154|||||TWO_SIDED|95.0|-9.36|1.06||||||||1.06|-9.36|
70956849|NCT01156792|141417187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.364|||||TWO_SIDED|95.0|-6.22|5.5||||||||5.50|-6.22|
70956850|NCT01156792|141417188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|||=|0.957|TWO_SIDED|95.0|-0.18|0.17|||Mixed Models Analysis|||||0.17|-0.18|=0.957
70956851|NCT01156792|141417188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.108|||=|0.213|TWO_SIDED|95.0|-0.28|0.06|||Mixed Models Analysis|||||0.06|-0.28|=0.213
70956852|NCT01156792|141417188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.038|||=|0.647|TWO_SIDED|95.0|-0.2|0.12|||Mixed Models Analysis|||||0.12|-0.20|=0.647
70956853|NCT01156792|141417188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.011|||=|0.894|TWO_SIDED|95.0|-0.17|0.15|||Mixed Models Analysis|||||0.15|-0.17|=0.894
70956854|NCT01156792|141417189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025|||=|0.811|TWO_SIDED|95.0|-0.23|0.18|||Mixed Models Analysis|||||0.18|-0.23|=0.811
70956855|NCT01156792|141417189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.133|||=|0.2|TWO_SIDED|95.0|-0.34|0.07|||Mixed Models Analysis|||||0.07|-0.34|=0.200
70956856|NCT01156792|141417189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.076|||=|0.415|TWO_SIDED|95.0|-0.26|0.11|||Mixed Models Analysis|||||0.11|-0.26|=0.415
70956857|NCT01156792|141417189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.084|||=|0.358|TWO_SIDED|95.0|-0.26|0.1|||Mixed Models Analysis|||||0.10|-0.26|=0.358
70956858|NCT01156792|141417190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.666|||=|0.285|TWO_SIDED|95.0|-2.24|7.57|||Mixed Models Analysis|||||7.57|-2.24|=0.285
70956859|NCT01156792|141417190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3|||=|0.035|TWO_SIDED|95.0|0.38|10.22|||Mixed Models Analysis|||||10.22|0.38|=0.035
70956860|NCT01156792|141417190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.036|||=|0.09|TWO_SIDED|95.0|-0.63|8.7|||Mixed Models Analysis|||||8.70|-0.63|=0.090
70956861|NCT01156792|141417190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.602|||=|0.047|TWO_SIDED|95.0|0.06|9.14|||Mixed Models Analysis|||||9.14|0.06|=0.047
70956862|NCT01156792|141417191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.014|||=|0.668|TWO_SIDED|95.0|-3.64|5.67|||Mixed Models Analysis|||||5.67|-3.64|=0.668
70956863|NCT01156792|141417191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.349|||=|0.156|TWO_SIDED|95.0|-1.29|7.98|||Mixed Models Analysis|||||7.98|-1.29|=0.156
70956864|NCT01156792|141417191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.496|||=|0.822|TWO_SIDED|95.0|-3.83|4.82|||Mixed Models Analysis|||||4.82|-3.83|=0.822
70876367|NCT00333866|141236654|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17||||0.537|TWO_SIDED|95.0|0.71|1.95|||Regression, Logistic|||P-values less than 0.05 (2-sided) considered statistically significant. Logistic regression method was used with treatment and center in the model, and the baseline score as covariate.||1.95|0.71|0.5370
70876368|NCT00333866|141236654|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.92||||0.0109|TWO_SIDED|95.0|1.16|3.18|||Regression, Logistic|||P-values less than 0.05 (2-sided) considered statistically significant. Logistic regression method was used with treatment and center in the model, and the baseline score as covariate.||3.18|1.16|0.0109
70876369|NCT00333866|141236654|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01||||0.9613|TWO_SIDED|95.0|0.61|1.68|||Regression, Logistic|||P-values less than 0.05 (2-sided) considered statistically significant. Logistic regression method was used with treatment and center in the model, and the baseline score as covariate.||1.68|0.61|0.9613
70876370|NCT00333866|141236655|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-12.71|||<|0.0001|TWO_SIDED|95.0|-17.56|-7.86|||ANCOVA|||Sleep Disturbance: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-7.86|-17.56|<.0001
70876371|NCT00333866|141236655|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-13.28|||<|0.0001|TWO_SIDED|95.0|-18.18|-8.38|||ANCOVA|||Sleep Disturbance: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-8.38|-18.18|<.0001
70876372|NCT00333866|141236655|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.2||||0.0038|TWO_SIDED|95.0|-12.06|-2.33|||ANCOVA|||Sleep Disturbance: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-2.33|-12.06|0.0038
70876373|NCT00333866|141236655|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.9||||0.0142|TWO_SIDED|95.0|1.19|10.61|||ANCOVA|||Snoring: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||10.61|1.19|0.0142
70876374|NCT00333866|141236655|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.92||||0.0414|TWO_SIDED|95.0|0.19|9.66|||ANCOVA|||Snoring: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||9.66|0.19|0.0414
70876375|NCT00333866|141236655|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.21||||0.6165|TWO_SIDED|95.0|-3.53|5.95|||ANCOVA|||Snoring: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||5.95|-3.53|0.6165
70876376|NCT00333866|141236655|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.24||||0.0005|TWO_SIDED|95.0|-14.44|-4.05|||ANCOVA|||Shortness of Breath, Headache: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-4.05|-14.44|0.0005
70876377|NCT00333866|141236655|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-11.92|||<|0.0001||95.0|-17.17|-6.68|||ANCOVA|||Shortness of Breath, Headache: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-6.68|-17.17|<.0001
70876378|NCT00333866|141236655|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.95||||0.0008|TWO_SIDED|95.0|-14.16|-3.74|||ANCOVA|||Shortness of Breath, Headache: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-3.74|-14.16|0.0008
70876379|NCT00333866|141236655|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.36||||0.0127|TWO_SIDED|95.0|0.08|0.64|||ANCOVA|||Quantity of Sleep: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.64|0.08|0.0127
70876380|NCT00333866|141236655|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.5||||0.0005|TWO_SIDED|95.0|0.22|0.79|||ANCOVA|||Quantity of Sleep: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.79|0.22|0.0005
70876381|NCT00333866|141236655|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21||||0.1453|TWO_SIDED|95.0|-0.07|0.49|||ANCOVA|||Quality of Sleep: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.49|-0.07|0.1453
70876382|NCT00333866|141236655|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.34||||0.1033|TWO_SIDED|95.0|-0.88|9.57|||ANCOVA|||Sleep Adequacy: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||9.57|-0.88|0.1033
70876383|NCT00333866|141236655|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|9.14||||0.0007|TWO_SIDED|95.0|3.88|14.41|||ANCOVA|||Sleep Adequacy: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||14.41|3.88|0.0007
70876384|NCT00333866|141236655|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.56||||0.337|TWO_SIDED|95.0|-2.68|7.81|||ANCOVA|||Sleep Adequacy: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||7.81|-2.68|0.3370
70876385|NCT00333866|141236655|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.01||||0.3308|TWO_SIDED|95.0|-2.05|6.07|||ANCOVA|||Somnolence: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||6.07|-2.05|0.3308
70956865|NCT01156792|141417191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|||=|0.555|TWO_SIDED|95.0|-2.94|5.46|||Mixed Models Analysis|||||5.46|-2.94|=0.555
70876386|NCT00333866|141236655|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.7||||0.7364|TWO_SIDED|95.0|-3.39|4.8|||ANCOVA|||Somnolence: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.80|-3.39|0.7364
70876387|NCT00333866|141236655|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.76||||0.7132|TWO_SIDED|95.0|-3.31|4.84|||ANCOVA|||Somnolence: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.84|-3.31|0.7132
71151454|NCT02819011|141795022|SUPERIORITY|||||||0.019||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes in both groups from baseline to 6 months||||0.019
70876388|NCT00333866|141236655|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-6.9||||0.0002|TWO_SIDED|95.0|-10.54|-3.25|||ANCOVA|||Overall sleep Problem Index: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-3.25|-10.54|0.0002
70876389|NCT00333866|141236655|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.25|||<|0.0001|TWO_SIDED|95.0|-11.94|-4.55|||ANCOVA|||Overall Sleep Problem Index: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-4.55|-11.94|<.0001
70876390|NCT00333866|141236655|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.36||||0.0197|TWO_SIDED|95.0|-8.02|-0.7|||ANCOVA|||Overall Sleep Problem Index: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.70|-8.02|0.0197
70876391|NCT00333866|141236656|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17||||0.3627|TWO_SIDED|95.0|-0.54|0.2|||ANCOVA|||FIQ Physical Impairment: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.20|-0.54|0.3627
70876392|NCT00333866|141236656|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.26||||0.1686|TWO_SIDED|95.0|-0.63|0.11|||ANCOVA|||FIQ Physical Impairment: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.11|-0.63|0.1686
70876393|NCT00333866|141236656|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18||||0.3468|TWO_SIDED|95.0|-0.55|0.19|||ANCOVA|||FIQ Physical Impairment: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.19|-0.55|0.3468
70876394|NCT00333866|141236656|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11||||0.7147|TWO_SIDED|95.0|-0.71|0.49|||ANCOVA|||FIQ Feel Good: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.49|-0.71|0.7147
70876395|NCT00333866|141236656|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.63||||0.0409|TWO_SIDED|95.0|-1.23|-0.03|||ANCOVA|||FIQ Feel Good: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.03|-1.23|0.0409
70876396|NCT00333866|141236656|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.04||||0.9077|TWO_SIDED|95.0|-0.56|0.63|||ANCOVA|||FIQ Feel Good: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.63|-0.56|0.9077
70876397|NCT00333866|141236656|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14||||0.5923|TWO_SIDED|95.0|-0.64|0.37|||ANCOVA|||FIQ Work Missed: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.37|-0.64|0.5923
70876398|NCT00333866|141236656|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61||||0.0174|TWO_SIDED|95.0|-1.12|-0.11|||ANCOVA|||FIQ Work Missed: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.11|-1.12|0.0174
70876399|NCT00333866|141236656|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16||||0.5408|TWO_SIDED|95.0|-0.66|0.35|||ANCOVA|||FIQ Work Missed: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.35|-0.66|0.5408
70876400|NCT00333866|141236656|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09||||0.7236|TWO_SIDED|95.0|-0.57|0.4|||ANCOVA|||FIQ Do Work: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.40|-0.57|0.7236
70876401|NCT00333866|141236656|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.71||||0.0045|TWO_SIDED|95.0|-1.19|-0.22|||ANCOVA|||FIQ Do Work: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.22|-1.19|0.0045
70876402|NCT00333866|141236656|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14||||0.5613||95.0|-0.63|0.34|||ANCOVA|||FIQ Do Work: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.34|-0.63|0.5613
70876403|NCT00333866|141236656|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14||||0.5609|TWO_SIDED|95.0|-0.6|0.33|||ANCOVA|||FIQ Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.33|-0.60|0.5609
70876404|NCT00333866|141236656|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.75||||0.0016|TWO_SIDED|95.0|-1.22|-0.28|||ANCOVA|||FIQ Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.28|-1.22|0.0016
70876405|NCT00333866|141236656|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.21||||0.3692|TWO_SIDED|95.0|-0.68|0.25|||ANCOVA|||FIQ Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.25|-0.68|0.3692
70876406|NCT00333866|141236656|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.24||||0.3294|TWO_SIDED|95.0|-0.73|0.25|||ANCOVA|||FIQ Fatigue: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.25|-0.73|0.3294
71151455|NCT02819011|141795024|SUPERIORITY|||||||0.572||||||priori threshold for statistical significance = 0.05|Generalized Estimating Equations|||Repeated measures to compare the changes of both groups from pre-intervention to post-intervention year.||||0.572
71151456|NCT02819011|141795025|SUPERIORITY|||||||0.65||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes between groups from baseline to 6 months||||0.650
71151457|NCT02819011|141795026|SUPERIORITY|||||||0.756||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes between groups from baseline to 6 months||||0.756
71151458|NCT02819011|141795029|SUPERIORITY|||||||0.769||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes between groups from baseline to 6 months||||0.769
71151459|NCT02819011|141795030|SUPERIORITY|||||||0.857||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes between groups from baseline to 6 months||||0.857
71151460|NCT02819011|141795031|SUPERIORITY|||||||0.829||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes between groups from baseline to 6 months||||0.829
70876407|NCT00333866|141236656|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56||||0.027|TWO_SIDED|95.0|-1.05|-0.06|||ANCOVA|||FIQ Fatigue: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.06|-1.05|0.0270
70876408|NCT00333866|141236656|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05||||0.8432|TWO_SIDED|95.0|-0.54|0.44|||ANCOVA|||FIQ Fatigue: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.44|-0.54|0.8432
70876409|NCT00333866|141236656|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.46||||0.0806|TWO_SIDED|95.0|-0.98|0.06|||ANCOVA|||FIQ Rested: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.06|-0.98|0.0806
70876410|NCT00333866|141236656|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.53||||0.047|TWO_SIDED|95.0|-1.06|-0.01|||ANCOVA|||FIQ Rested: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.01|-1.06|0.0470
70876411|NCT00333866|141236656|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.23||||0.3845|TWO_SIDED|95.0|-0.75|0.29|||ANCOVA|||FIQ Rested: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.29|-0.75|0.3845
70876412|NCT00333866|141236656|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.12||||0.6326|TWO_SIDED|95.0|-0.37|0.6|||ANCOVA|||FIQ Stiffness: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.60|-0.37|0.6326
70876413|NCT00333866|141236656|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22||||0.374|TWO_SIDED|95.0|-0.71|0.27|||ANCOVA|||FIQ Stiffness: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.27|-0.71|0.3740
70876414|NCT00333866|141236656|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.03||||0.8936|TWO_SIDED|95.0|-0.45|0.52|||ANCOVA|||FIQ Stiffness: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.52|-0.45|0.8936
70876415|NCT00333866|141236656|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.19||||0.4743|TWO_SIDED|95.0|-0.73|0.34|||ANCOVA|||FIQ Anxiety: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.34|-0.73|0.4743
70876416|NCT00333866|141236656|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.64||||0.0192|TWO_SIDED|95.0|-1.18|-0.1|||ANCOVA|||FIQ Anxiety: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.10|-1.18|0.0192
70876417|NCT00333866|141236656|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18||||0.5101|TWO_SIDED|95.0|-0.71|0.35|||ANCOVA|||FIQ anxiety: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.35|-0.71|0.5101
70876418|NCT00333866|141236656|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.2||||0.4617|TWO_SIDED|95.0|-0.75|0.34|||ANCOVA|||FIQ Depression: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.34|-0.75|0.4617
70876419|NCT00333866|141236656|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.97||||0.0006|TWO_SIDED|95.0|-1.51|-0.42|||ANCOVA|||FIQ Depression: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.42|-1.51|0.0006
70876420|NCT00333866|141236656|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.33||||0.229|TWO_SIDED|95.0|-0.88|0.21|||ANCOVA|||FIQ Depression: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.21|-0.88|0.2290
70876421|NCT00333866|141236657|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.44||||0.42|TWO_SIDED|95.0|-4.95|2.06|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||2.06|-4.95|0.4200
70876422|NCT00333866|141236657|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-5.85||||0.0012|TWO_SIDED|95.0|-9.38|-2.31|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-2.31|-9.38|0.0012
70876423|NCT00333866|141236657|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.17||||0.5126|TWO_SIDED|95.0|-4.68|2.34|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||2.34|-4.68|0.5126
70876424|NCT00333866|141236658|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.51||||0.7781|TWO_SIDED|95.0|-4.07|3.05|||ANCOVA|||Physical functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||3.05|-4.07|0.7781
70876425|NCT00333866|141236658|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.99||||0.2792|TWO_SIDED|95.0|-1.62|5.59|||ANCOVA|||Physical Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||5.59|-1.62|0.2792
70876426|NCT00333866|141236658|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.58||||0.7512|TWO_SIDED|95.0|-3.0|4.15|||ANCOVA|||Physical Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.15|-3.00|0.7512
70876427|NCT00333866|141236658|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.02||||0.649|TWO_SIDED|95.0|-3.39|5.43|||ANCOVA|||Physical role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||5.43|-3.39|0.6490
70876428|NCT00333866|141236658|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.5||||0.5105|TWO_SIDED|95.0|-2.96|5.96|||ANCOVA|||Physical Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||5.96|-2.96|0.5105
70876429|NCT00333866|141236658|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.39||||0.8625|TWO_SIDED|95.0|-4.04|4.82|||ANCOVA|||Physical Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.82|-4.04|0.8625
70956866|NCT01156792|141417192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.992|||=|0.367|TWO_SIDED|95.0|-2.35|6.33|||Mixed Models Analysis|||||6.33|-2.35|=0.367
70876430|NCT00333866|141236658|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.87||||0.1489|TWO_SIDED|95.0|-1.39|9.12|||ANCOVA|||Emotional Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||9.12|-1.39|0.1489
70876431|NCT00333866|141236658|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.24||||0.0213|TWO_SIDED|95.0|0.93|11.54|||ANCOVA|||Emotional Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||11.54|0.93|0.0213
70876432|NCT00333866|141236658|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.75||||0.162|TWO_SIDED|95.0|-1.51|9.02|||ANCOVA|||Emotional Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||9.02|-1.51|0.1620
70876433|NCT00333866|141236658|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.85||||0.2446|TWO_SIDED|95.0|-1.95|7.65|||ANCOVA|||Social Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||7.65|-1.95|0.2446
70876434|NCT00333866|141236658|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.01||||0.0429|TWO_SIDED|95.0|0.16|9.85|||ANCOVA|||Social Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||9.85|0.16|0.0429
70876435|NCT00333866|141236658|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.35||||0.1721|TWO_SIDED|95.0|-1.46|8.16|||ANCOVA|||Social Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||8.16|-1.46|0.1721
70876436|NCT00333866|141236658|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.08||||0.0291|TWO_SIDED|95.0|0.42|7.74|||ANCOVA|||Mental Health: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||7.74|0.42|0.0291
70876437|NCT00333866|141236658|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.93||||0.0017|TWO_SIDED|95.0|2.23|9.62|||ANCOVA|||Mental Health: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||9.62|2.23|0.0017
70876438|NCT00333866|141236658|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.32||||0.0763|TWO_SIDED|95.0|-0.35|6.99|||ANCOVA|||Mental Health: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||6.99|-0.35|0.0763
70876439|NCT00333866|141236658|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.58||||0.1524|TWO_SIDED|95.0|-0.95|6.11|||ANCOVA|||Bodily Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||6.11|-0.95|0.1524
70876440|NCT00333866|141236658|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.36||||0.0032|TWO_SIDED|95.0|1.8|8.93|||ANCOVA|||Bodily Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||8.93|1.80|0.0032
70876441|NCT00333866|141236658|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.82||||0.118|TWO_SIDED|95.0|-0.72|6.36|||ANCOVA|||Bodily Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||6.36|-0.72|0.1180
70876442|NCT00333866|141236658|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.15||||0.1081|TWO_SIDED|95.0|-0.69|6.99|||ANCOVA|||Vitality: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||6.99|-0.69|0.1081
70876443|NCT00333866|141236658|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.1||||0.0101|TWO_SIDED|95.0|1.22|8.99|||ANCOVA|||Vitality: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||8.99|1.22|0.0101
70876444|NCT00333866|141236658|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.75||||0.7031|TWO_SIDED|95.0|-3.1|4.6|||ANCOVA|||Vitality: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.60|-3.10|0.7031
70876445|NCT00333866|141236658|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.27||||0.4253|TWO_SIDED|95.0|-1.86|4.39|||ANCOVA|||General Health Perception: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.39|-1.86|0.4253
70876446|NCT00333866|141236658|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.73||||0.091|TWO_SIDED|95.0|-0.44|5.89|||ANCOVA|||General Health Perception: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||5.89|-0.44|0.0910
70876447|NCT00333866|141236658|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.82||||0.2526|TWO_SIDED|95.0|-1.3|4.95|||ANCOVA|||General Health Perception: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.95|-1.30|0.2526
70876448|NCT00333866|141236658|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.62||||0.0195|TWO_SIDED|95.0|0.42|4.82|||ANCOVA|||Mental Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.82|0.42|0.0195
70876449|NCT00333866|141236658|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.66||||0.0013|TWO_SIDED|95.0|1.44|5.88|||ANCOVA|||Mental Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||5.88|1.44|0.0013
70876450|NCT00333866|141236658|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.14||||0.0568|TWO_SIDED|95.0|-0.06|4.34|||ANCOVA|||Mental Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.34|-0.06|0.0568
70876451|NCT00333866|141236658|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13||||0.8529|TWO_SIDED|95.0|-1.54|1.27|||ANCOVA|||Physical Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||1.27|-1.54|0.8529
70876452|NCT00333866|141236658|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.54||||0.4564|TWO_SIDED|95.0|-0.88|1.96|||ANCOVA|||Physical Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||1.96|-0.88|0.4564
70876453|NCT00333866|141236658|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.13||||0.8576|TWO_SIDED|95.0|-1.28|1.54|||ANCOVA|||Physical Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||1.54|-1.28|0.8576
70876454|NCT00333866|141236659|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.29||||0.7384|TWO_SIDED|95.0|-1.98|1.4|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||1.40|-1.98|0.7384
70876455|NCT00333866|141236659|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.41||||0.1044|TWO_SIDED|95.0|-3.12|0.29|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.29|-3.12|0.1044
70876456|NCT00333866|141236659|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.87||||0.3137|TWO_SIDED|95.0|-2.58|0.83|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.83|-2.58|0.3137
70876457|NCT00333866|141236660|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.59||||0.09|TWO_SIDED|95.0|-1.28|0.09|||ANCOVA|||HADS-Anxiety Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.09|-1.28|0.0900
70876458|NCT00333866|141236660|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.5||||0.1564|TWO_SIDED|95.0|-1.2|0.19|||ANCOVA|||HADS-Anxiety Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.19|-1.20|0.1564
70876459|NCT00333866|141236660|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11||||0.7519|TWO_SIDED|95.0|-0.8|0.58|||ANCOVA|||HADS-Anxiety Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.58|-0.80|0.7519
70876460|NCT00333866|141236660|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.15||||0.6416|TWO_SIDED|95.0|-0.5|0.8|||ANCOVA|||HADS-Depression Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.80|-0.50|0.6416
70876461|NCT00333866|141236660|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.59||||0.0778|TWO_SIDED|95.0|-1.25|0.07|||ANCOVA|||HADS-Depression Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.07|-1.25|0.0778
70876462|NCT00333866|141236660|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.21||||0.5191|TWO_SIDED|95.0|-0.87|0.44|||ANCOVA|||HADS-Depression Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.44|-0.87|0.5191
70876463|NCT00333866|141236661|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.44||||0.534|TWO_SIDED|95.0|-5.97|3.09|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||3.09|-5.97|0.5340
70876464|NCT00333866|141236661|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.44||||0.0014|TWO_SIDED|95.0|-12.0|-2.88|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-2.88|-12.00|0.0014
70876465|NCT00333866|141236661|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.56||||0.2694|TWO_SIDED|95.0|-7.09|1.98|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||1.98|-7.09|0.2694
70876466|NCT00333866|141236662|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|263.77||||0.1277|TWO_SIDED|95.0|-75.78|603.33|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. P value was calculated using analysis of variance (ANOVA), with treatment and center in the model.||603.33|-75.78|0.1277
70876467|NCT00333866|141236662|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|47.89||||0.7829|TWO_SIDED|95.0|-293.2|389.02|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. P value was calculated using ANOVA, with treatment and center in the model.||389.02|-293.2|0.7829
70876468|NCT00333866|141236662|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-11.51||||0.9471|TWO_SIDED|95.0|-351.9|328.86|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. P value was calculated using ANOVA, with treatment and center in the model.||328.86|-351.9|0.9471
70876469|NCT01454947|141236664|SUPERIORITY|||||||0.007||||||P values computed using difference between proportions (z value) with Bonferroni correction.|2 proportion Z-test|||||||0.007
70876470|NCT00456547|141236673|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Adjusted for 12 comparisons|t-test, 2 sided|||||||<0.05
70876471|NCT00456547|141236674|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Corrected for 12 comparisons.|t-test, 2 sided|||||||<0.05
70876472|NCT00456547|141236675|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Corrected for 12 comparisons|t-test, 2 sided|||||||<0.05
70876473|NCT00456547|141236676|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Corrected for 12 comparisons|Wilcoxon (Mann-Whitney)|||||||<0.05
70876474|NCT02648178|141236719|OTHER|We used a linear mixed model to estimate associations between cigarette smoking and that of e-cigarette smoking, by week and their interactions. We also used the same model to estimate association between biomarkers such as NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol), Nicotine, Cotinine, Hydro and Creatinine and CO (Carbon Monoxide) level,by week and their interactions.||||||||||||We tested whether there were significant associations between cigarette smoking and e-cigarette smoking, as well as whether there were significant associations between biomarkers mentioned above with CO level.||We provided estimated values of coefficients from model and their 95% confidence intervals.|||We used a linear mixed model to estimate associations between cigarette smoking and that of e-cigarette smoking, week and their interactions. We also used the same model to estimate association between biomarkers such as NNAL, Nicotine, Cotinine, Hydro and Creatinine and CO level, week and their interactions.|||
70876475|NCT01285310|141236721|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-7.4||||0.3134|TWO_SIDED|95.0|-27.1|7.0|||Chi-squared||2-sided 95% CI of the proportion difference is based on a normal approximation to the binomial distribution|Significance testing was done using the following closed procedure; if the overall test among treatments is statistically significant at the 0.05 level, pair-wise comparisons (30 mg versus PBO, and 20 mg versus PBO, using a 0.05 two-sided significance level) will be performed||7.0|-27.1|0.3134
70876476|NCT01285310|141236721|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-1.2||||0.8721|TWO_SIDED|95.0|-16.2|13.8|||Chi-squared||2-sided 95% CI is based on a normal approximation to the binomial distribution|||13.8|-16.2|0.8721
70876477|NCT01285310|141236722|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.004|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
70876478|NCT01285310|141236722|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.091|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
70876479|NCT01285310|141236723|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-4.5||||||||||||||||||
70876480|NCT01285310|141236723|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|3.6||||||||||||||||||
70876481|NCT01285310|141236724|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.007||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24; treatment group as a factor and the baseline value as a covariate.||||||
70876482|NCT01285310|141236724|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.15|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, treatment group as a factor and the baseline value as a covariate.|||||
70876483|NCT01285310|141236725|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16; treatment group as a factor and the baseline value as a covariate|||||
70876484|NCT01285310|141236725|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.77|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16; treatment group as a factor and the baseline value as a covariate.|||||
70876485|NCT01285310|141236726|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.21||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16; treatment group as a factor and the baseline value as a covariate.||||||
70876486|NCT01285310|141236726|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24; treatment group as a factor and the baseline value as a covariate.||||||
70876487|NCT01285310|141236727|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-5.5||||||||||||||||||
70876488|NCT01285310|141236727|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-7.2||||||||||||||||||
70876489|NCT01285310|141236728|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.14||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, treatment group as a factor and the baseline value as a covariate.||||||
70876490|NCT01285310|141236728|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.02|||||TWO_SIDED|||||||Based on an analysis of covariance model for the change from baseline at Week 24; treatment group as a factor and the baseline value as a covariate.||||||
70876491|NCT01285310|141236729|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.15|||||||||||||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||||
70876492|NCT01285310|141236729|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61|||||||||||||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||||
70876493|NCT01285310|141236730|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.58|||||TWO_SIDED||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
70876494|NCT01285310|141236730|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.26||||||||||||||||||
70876495|NCT01285310|141236731|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-35.54|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
70876496|NCT01285310|141236731|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-38.37|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
70876497|NCT01285310|141236732|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-14.35|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
70956867|NCT01156792|141417192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.147|||=|0.332|TWO_SIDED|95.0|-2.2|6.49|||Mixed Models Analysis|||||6.49|-2.20|=0.332
70956868|NCT01156792|141417192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.331|||=|0.277|TWO_SIDED|95.0|-1.88|6.55|||Mixed Models Analysis|||||6.55|-1.88|=0.277
70956869|NCT01156792|141417192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.521|||=|0.467|TWO_SIDED|95.0|-2.59|5.63|||Mixed Models Analysis|||||5.63|-2.59|=0.467
70956870|NCT01156792|141417193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.575|||=|0.789|TWO_SIDED|95.0|-3.65|4.8|||Mixed Models Analysis|||||4.80|-3.65|=0.789
70956871|NCT01156792|141417193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.669|||=|0.087|TWO_SIDED|95.0|-0.54|7.87|||Mixed Models Analysis|||||7.87|-0.54|=0.087
70956872|NCT01156792|141417193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||=|0.923|TWO_SIDED|95.0|-3.84|4.24|||Mixed Models Analysis|||||4.24|-3.84|=0.923
70956873|NCT01156792|141417193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.137|||=|0.571|TWO_SIDED|95.0|-5.08|2.81|||Mixed Models Analysis|||||2.81|-5.08|=0.571
70956874|NCT01156792|141417194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.014|||=|0.668|TWO_SIDED|95.0|-3.64|5.67|||Mixed Models Analysis|||||5.67|-3.64|=0.668
70956875|NCT01156792|141417194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.349|||=|0.156|TWO_SIDED|95.0|-1.29|7.98|||Mixed Models Analysis|||||7.98|-1.29|=0.156
70956876|NCT01156792|141417194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.496|||=|0.822|TWO_SIDED|95.0|-3.83|4.82|||Mixed Models Analysis|||||4.82|-3.83|=0.822
70956877|NCT01156792|141417194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|||=|0.555|TWO_SIDED|95.0|-2.94|5.46|||Mixed Models Analysis|||||5.46|-2.94|=0.555
70956878|NCT01156792|141417195|SUPERIORITY_OR_OTHER||||||=|0.408||95.0|||||Fisher Exact|||||||=0.408
70956879|NCT01156792|141417195|SUPERIORITY_OR_OTHER||||||=|0.138||95.0|||||Fisher Exact|||||||=0.138
70956880|NCT01156792|141417195|SUPERIORITY_OR_OTHER||||||=|0.797||95.0|||||Fisher Exact|||||||=0.797
70956881|NCT01156792|141417195|SUPERIORITY_OR_OTHER||||||=|0.408||95.0|||||Fisher Exact|||||||=0.408
70876498|NCT01285310|141236732|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.34|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
70956882|NCT00495586|141417222|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence.|Mean Difference (Final Values)|14.2|STANDARD_DEVIATION|9.5|<|0.05|TWO_SIDED|95.0|3.7|24.3|||Chi-squared|||For the comparison of the efficacy of antibiotic versus placebo, we accepted a null hypothesis if the cure rate in the intervention group was the same or ±7% as that observed in the placebo arm. Based on previous studies, the expected rate of cure among patients assigned to antibiotic therapy was 90%. For an alpha of 0.05 and a beta of 0.2 and accepting possible losses of 15%, we calculated that the sample size is 677 patients in total.||24.3|3.7|<0.05
70956883|NCT00158860|141417224|SUPERIORITY||Kaplan-Meier estimates|27.3|||<|0.001|TWO_SIDED|95.0|16.0|38.6|||Log Rank|||||38.6|16.0|<0.001
70956884|NCT00158860|141417224|SUPERIORITY||Hazard Ratio (HR)|0.401|||<|0.001|TWO_SIDED|95.0|0.282|0.57|||Log Rank|||||0.570|0.282|<0.001
70956885|NCT00158860|141417225|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon rank sum test|||||||<0.001
70956886|NCT03618823|141417269|EQUIVALENCE|All pain scores were included due to the sample size. Alpha =.05 Power = .80 Desired effect size of 0.30 Size of n=145 in each group was determined, however this was not reached for sufficient power.||||||0.912|||||||Mixed Models Analysis|Two-way mixed-model analysis of variance||There will be no difference in pain scores between opioid and non-opioid groups from before medication to after while controlling for total duration of mediation use (duration mean=10.11 days).||||.912
70956887|NCT03618823|141417270|SUPERIORITY||Odds Ratio (OR)|1.311||||0.63|TWO_SIDED|95.0|0.494|3.478|||Fisher Exact|||There will be no difference in ED (Emergency Department) or urgent care visits between opioid and non-opioid pain control groups.||3.478|.494|.630
70956888|NCT00964886|141417283|SUPERIORITY_OR_OTHER|||||||0.7|||||||ANCOVA|||In an intent-to-treat analysis of all randomized participants assigned to experimental drug (desipramine) or active placebo (benztropine) an analysis of variance compared mean Descriptor Differential Scale scores at 12 weeks (or last observation carried forward) adjusted fro mean baseline score ( = ).||||0.7
70956889|NCT00964886|141417284|SUPERIORITY_OR_OTHER|||||||0.84|||||||ANCOVA|Means are adjusted for baseline Roland and Morris scores.||In the intent-to-treat sample of all randomized participants assigned to experimental drug (desipramine) or active placebo (benztropine) an analysis of variance (ANOVA) compared mean Roland and Morris scores at 12 weeks adjusted for mean baseline scores.||||0.84
70956890|NCT00964886|141417285|SUPERIORITY_OR_OTHER|||||||0.6|||||||ANCOVA|||||||0.6
70956891|NCT00964886|141417286|SUPERIORITY_OR_OTHER|||||||0.8|||||||ANCOVA|||This analysis compares outcomes for participants assigned at baseline to receive cognitive behavioral therapy or not to receive cognitive behavioral therapy (behavioral effect)||||0.8
70956892|NCT00523640|141417290|SUPERIORITY_OR_OTHER||Proportion responding|0.24|||||TWO_SIDED|95.0|0.1|0.44||||||||0.44|0.10|
70956893|NCT04587752|141417295|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||.047
70956894|NCT04587752|141417296|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||.01
70956895|NCT04587752|141417297|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
70956896|NCT03535597|141417325|OTHER||Risk Ratio (RR)|0.99||||0.906|TWO_SIDED|95.0|0.89|1.11|||Chi-squared|||||1.11|0.89|0.906
70956897|NCT03535597|141417325|OTHER||Risk Ratio (RR)|1.27||||0.002|TWO_SIDED|95.0|1.09|1.53|||Chi-squared|||||1.53|1.09|0.002
70956898|NCT03535597|141417325|OTHER||Risk Ratio (RR)|0.97||||0.613|TWO_SIDED|95.0|0.86|1.09|||Chi-squared|||||1.09|0.86|0.613
70956899|NCT03535597|141417326|OTHER||Mean Difference (Net)|-98.5|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
70956900|NCT03535597|141417326|OTHER||Mean Difference (Net)|-120.6|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||< 0.001
70956901|NCT03535597|141417326|OTHER||Mean Difference (Net)|-94.3|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||< 0.001
70876499|NCT01285310|141236733|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.59|||||TWO_SIDED||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
70956902|NCT03535597|141417327|OTHER||Risk Ratio (RR)|0.77||||0.744|TWO_SIDED|95.0|0.23|2.57|||Fisher Exact|||||2.57|0.23|0.744
70956903|NCT03535597|141417327|OTHER||Risk Ratio (RR)|1.02|||>|0.999|TWO_SIDED|95.0|0.31|3.41|||Fisher Exact|||||3.41|0.31|>0.999
70956904|NCT03535597|141417327|OTHER||Risk Ratio (RR)|0.67||||0.724|TWO_SIDED|95.0|0.18|2.46|||Fisher Exact|||||2.46|0.18|0.724
70956905|NCT03535597|141417328|OTHER||Risk Ratio (RR)|1.44||||0.594|TWO_SIDED|95.0|0.56|3.76|||Fisher Exact|||||3.76|0.56|0.594
70956906|NCT03535597|141417328|OTHER||Risk Ratio (RR)|1.1|||>|0.999|TWO_SIDED|95.0|0.37|3.26|||Fisher Exact|||||3.26|0.37|>0.999
70956907|NCT03535597|141417328|OTHER||Risk Ratio (RR)|1.45||||0.581|TWO_SIDED|95.0|0.55|3.88|||Fisher Exact|||||3.88|0.55|0.581
70956908|NCT03535597|141417329|OTHER||Risk Ratio (RR)|1.92||||0.284|TWO_SIDED|95.0|0.71|5.22|||Fisher Exact|||||5.22|0.71|0.284
70956909|NCT03535597|141417329|OTHER||Risk Ratio (RR)|2.1||||0.243|TWO_SIDED|95.0|0.75|5.9|||Fisher Exact|||||5.9|0.75|0.243
70956910|NCT03535597|141417329|OTHER||Risk Ratio (RR)|2.01||||0.266|TWO_SIDED|95.0|0.74|5.54|||Fisher Exact|||||5.54|0.74|0.266
70956911|NCT02632526|141417365|SUPERIORITY_OR_OTHER||Slope|1.24|STANDARD_ERROR_OF_MEAN|0.0433|||TWO_SIDED|90.0|1.17|1.31||||||||1.31|1.17|
70956912|NCT02632526|141417365|SUPERIORITY_OR_OTHER||Slope|0.322|STANDARD_ERROR_OF_MEAN|0.182|||TWO_SIDED|90.0|-0.0124|0.656||||||||0.656|-0.0124|
70956913|NCT02632526|141417366|SUPERIORITY_OR_OTHER||Slope|1.22|STANDARD_ERROR_OF_MEAN|0.0813|||TWO_SIDED|90.0|1.08|1.36||||||Day 1||1.36|1.08|
70956914|NCT02632526|141417368|SUPERIORITY_OR_OTHER||Slope|1.23|STANDARD_ERROR_OF_MEAN|0.0851|||TWO_SIDED|90.0|1.08|1.38||||||Day 10||1.38|1.08|
70956915|NCT02632526|141417369|SUPERIORITY_OR_OTHER||Slope|1.55|STANDARD_ERROR_OF_MEAN|0.0692|||TWO_SIDED|90.0|1.43|1.66||||||||1.66|1.43|
70876500|NCT01285310|141236733|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-3.84|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
70956916|NCT02632526|141417369|SUPERIORITY_OR_OTHER||Slope|0.35|STANDARD_ERROR_OF_MEAN|0.176|||TWO_SIDED|90.0|0.0315|0.669||||||||0.669|0.0315|
70956917|NCT02632526|141417370|SUPERIORITY_OR_OTHER||Slope|1.48|STANDARD_ERROR_OF_MEAN|0.0839|||TWO_SIDED|90.0|1.34|1.63||||||For Day 1||1.63|1.34|
70956918|NCT02632526|141417370|SUPERIORITY_OR_OTHER||Slope|1.43|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|90.0|1.25|1.6||||||Day 10||1.60|1.25|
70956919|NCT02632526|141417383|SUPERIORITY_OR_OTHER||Ratio|28.13|||||TWO_SIDED|90.0|20.98|37.73||||||Cmax||37.73|20.98|
70956920|NCT02632526|141417384|SUPERIORITY_OR_OTHER||Ratio|64.58|||||TWO_SIDED|90.0|54.34|76.74||||||AUC(0-τ)||76.74|54.34|
70956921|NCT03954392|141417396|OTHER||||||<|0.05|||||||ANCOVA|Only one statistical test was conducted, therefore no adjustments for multiple comparisons was needed.||Statistical analysis will compare the post-intervention scores on the primary outcome (Faux Pas Recognition Test scores), controlling for pre-intervention scores.||||< 0.05
70956922|NCT03954392|141417397|OTHER||||||<|0.05|||||||ANCOVA|||||||< 0.05
70956923|NCT03143166|141417432|OTHER||Adjusted gMean ratio Test/Reference (%)|28.85|STANDARD_ERROR_OF_MEAN|86.7|||TWO_SIDED|90.0|21.346|38.996|||ANOVA|An analysis of variance (ANOVA) was used on the logarithmic scale including effects for 'subjects' and 'treatment'.|The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).|||38.996|21.346|
70956924|NCT03143166|141417433|OTHER||Adjusted gMean ratio Test/Reference (%)|26.37|STANDARD_ERROR_OF_MEAN|76.6|||TWO_SIDED|90.0|20.066|34.665|||ANOVA|An analysis of variance (ANOVA) was used on the logarithmic scale including effects for 'subjects' and 'treatment'.|The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).|||34.665|20.066|
70956925|NCT03143166|141417434|OTHER||Adjusted gMean ratio Test/Reference (%)|28.02|STANDARD_ERROR_OF_MEAN|83.4|||TWO_SIDED|90.0|20.914|37.537|||ANOVA|An analysis of variance (ANOVA) was used on the logarithmic scale including effects for 'subjects' and 'treatment'.|The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).|||37.537|20.914|
70956926|NCT03143166|141417435|OTHER||Adjusted gMean ratio Test/Reference (%)|27.56|STANDARD_ERROR_OF_MEAN|75.6|||TWO_SIDED|90.0|21.023|36.118|||ANOVA|An analysis of variance (ANOVA) was used on the logarithmic scale including effects for 'subjects' and 'treatment'.|The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).|||36.118|21.023|
70876501|NCT01285310|141236734|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|5.93|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
70956927|NCT03143166|141417436|OTHER||Adjusted gMean ratio Test/Reference (%)|30.59|STANDARD_ERROR_OF_MEAN|76.8|||TWO_SIDED|90.0|23.26|40.234|||ANOVA|An analysis of variance (ANOVA) was used on the logarithmic scale including effects for 'subjects' and 'treatment'.|The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).|||40.234|23.260|
70956928|NCT03143166|141417437|OTHER||Adjusted gMean ratio Test/Reference (%)|30.61|STANDARD_ERROR_OF_MEAN|74.9|||TWO_SIDED|90.0|23.404|40.037|||ANOVA|An analysis of variance (ANOVA) was used on the logarithmic scale including effects for 'subjects' and 'treatment'.|The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).|||40.037|23.404|
70956929|NCT01846494|141417468|OTHER|||||||0.6173|||||||Log Rank|||||||0.6173
70956930|NCT05180500|141417469|OTHER|||||||0.7|||||||Fisher Exact|||||||.70
70956931|NCT05180500|141417470|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Concentrations that were below the lower limit of quantification (\<15 ng/mL) were set to 7.5 ng/mL for analyses.||||<.001
70956932|NCT05180500|141417473|OTHER|||||||0.28|||||||Fisher Exact|||||||0.28
70956933|NCT05180500|141417474|OTHER|||||||0.6|||||||t-test, 2 sided|||||||0.60
70956934|NCT05180500|141417475|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Concentrations that were below the lower limit of quantification (\<15 ng/mL) were set to 7.5 ng/mL for analyses.||||<.001
70956935|NCT05180500|141417476|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Concentrations that were below the lower limit of quantification (\<15 ng/mL) were set to 7.5 ng/mL for analyses.||||<.001
70956936|NCT05180500|141417477|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Concentrations that were below the lower limit of quantification (\<15 ng/mL) were set to 7.5 ng/mL for analyses.||||<.001
70956937|NCT05180500|141417478|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70956938|NCT03541174|141417495|SUPERIORITY||LS Mean difference to placebo|-3.79||||0.0042|TWO_SIDED|97.5|-6.76|-0.82||Mixed effects model for Repeated Measures: Change from baseline in SiSBP = baseline SiSBP + treatment + visit + treatment x visit + baseline x visit.|Mixed Models Analysis|||||-0.82|-6.76|0.0042
70876502|NCT01285310|141236734|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.77|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||||
70876503|NCT01285310|141236735|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|4.7|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
70876504|NCT01285310|141236735|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|58.05||||||||||||||||||
70876505|NCT01285310|141236736|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|7.18|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
70876506|NCT01285310|141236736|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-16.19|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
70956939|NCT03541174|141417495|SUPERIORITY||LS Mean difference to placebo|-3.73||||0.0046|TWO_SIDED|97.5|-6.67|-0.78||Mixed effects model for Repeated Measures: Change from baseline in SiSBP = baseline SiSBP + treatment + visit + treatment x visit + baseline x visit.|Mixed Models Analysis|||||-0.78|-6.67|0.0046
70956940|NCT03541174|141417496|SUPERIORITY||LS mean difference to placebo.|-5.82|||<|0.0001|TWO_SIDED|95.0|-7.94|-3.71||Mixed effects model for Repeated Measures: Change from DB-WD baseline in SiSBP = DB-WD baseline SiSBP + stratum (randomized treatment in DB part) + treatment + visit + treatment x visit + DB-WD baseline x visit.|Mixed Models Analysis|||||-3.71|-7.94|<0.0001
70956941|NCT03541174|141417497|OTHER||LS Mean difference to placebo|-3.94|||<|0.0001|TWO_SIDED|95.0|-5.57|-2.31||Mixed effects model for Repeated Measures: Change from baseline in SiDBP = baseline SiDBP + treatment + visit + treatment x visit + baseline x visit.|Mixed Models Analysis|||||-2.31|-5.57|<0.0001
70876507|NCT01285310|141236737|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
70876508|NCT01285310|141236737|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.1|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||||
70876509|NCT01285310|141236738|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-3.9||||||||||||||||||
70876510|NCT01285310|141236738|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|13.4||||||||||||||||||
70876511|NCT01285310|141236739|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-3.9||||||||||||||||||
70876512|NCT01285310|141236739|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|2.9||||||||||||||||||
70876513|NCT01285310|141236740|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-5.4||||||||||||||||||
70876514|NCT01285310|141236740|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|2.1||||||||||||||||||
70876515|NCT01285310|141236741|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-6.5||||||||||||||||||
70876516|NCT01285310|141236741|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-2.2||||||||||||||||||
70876517|NCT01285310|141236742|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-1.3||||||||||||||||||
70876518|NCT01285310|141236742|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-2.5||||||||||||||||||
70876519|NCT01285310|141236743|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-1.5||||||||||||||||||
70876520|NCT01285310|141236743|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|9.5||||||||||||||||||
70876521|NCT01285310|141236744|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-1.4|||||TWO_SIDED|||||||||||||
70876522|NCT01285310|141236744|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|1.5|||||TWO_SIDED|||||||||||||
70876523|NCT01285310|141236745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24 with treatment group as a factor and the baseline value as a covariate.|||||
70876524|NCT01285310|141236745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.98|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24 with treatment group as a factor and the baseline value as a covariate.|||||
70876525|NCT01285310|141236746|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.94||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24; treatment group as a factor and the baseline value as a covariate.||||||
70876526|NCT01285310|141236746|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.24||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24; treatment group as a factor and the baseline value as a covariate.||||||
70876527|NCT01285310|141236747|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|-4.3||||||||||||||||||
70876528|NCT01285310|141236747|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|4.6||||||||||||||||||
70876529|NCT01285310|141236748|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24 with treatment group as a factor and the baseline value as a covariate.|||||
70876530|NCT01285310|141236748|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24 with treatment group as a factor and the baseline value as a covariate.|||||
70876531|NCT01285310|141236749|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.6|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
70876532|NCT01285310|141236749|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.01|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24; treatment group as a factor and the baseline value as a covariate.|||||
70876533|NCT01285310|141236750|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.86|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||||
70876534|NCT01285310|141236750|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-7.02|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||||
70876535|NCT01285310|141236751|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-34.82|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||||
70876536|NCT01285310|141236751|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-37.82|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||||
70876537|NCT01285310|141236752|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-14.34|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
70876538|NCT01285310|141236752|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-12.5|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
70876539|NCT01285310|141236753|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|5.85|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
70876540|NCT01285310|141236753|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.8|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
70956942|NCT03541174|141417497|OTHER||LS Mean difference to placebo|-4.47|||<|0.0001|TWO_SIDED|95.0|-6.09|-2.85||Mixed effects model for Repeated Measures: Change from baseline in SiDBP = baseline SiDBP + treatment + visit + treatment x visit + baseline x visit.|Mixed Models Analysis|||||-2.85|-6.09|<0.0001
70956943|NCT03541174|141417498|OTHER||LS Mean difference to placebo|-4.18|||<|0.0001|TWO_SIDED|95.0|-6.25|-2.12|||ANCOVA|||24-hour mean systolic (SBP)||-2.12|-6.25|<0.0001
70876541|NCT01285310|141236754|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|1.57|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
70876542|NCT01285310|141236754|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-5.72|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
70876543|NCT01285310|141236755|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|8.29|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
70876544|NCT01285310|141236755|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|67.09|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
70876545|NCT01285310|141236756|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|12.05|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
70876546|NCT01285310|141236756|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-6.54|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
70876547|NCT01285310|141236757|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||||
70876548|NCT01285310|141236757|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.7|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||||
70876549|NCT01285310|141236758|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|5.4||||||||||||||||||
70876550|NCT01285310|141236758|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|12.6||||||||||||||||||
70876551|NCT01285310|141236759|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-11.9||||||||||||||||||
70876552|NCT01285310|141236759|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-0.3||||||||||||||||||
70876553|NCT01285310|141236760|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-11.2||||||||||||||||||
70876554|NCT01285310|141236760|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-5.0||||||||||||||||||
70876555|NCT00143403|141236794|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||||95.0|0.67|1.2|||||HR: Irinotecan+5-FU/FA / 5-FU/FA|||1.20|0.67|
70876556|NCT00143403|141236794|SUPERIORITY_OR_OTHER|||||||0.468||95.0|||||Log Rank|||||||0.468
70956944|NCT03541174|141417498|OTHER||LS Mean difference to placebo|-5.9|||<|0.0001|TWO_SIDED|95.0|-7.94|-3.85|||ANCOVA|||24-hour mean systolic (SBP)||-3.85|-7.94|<0.0001
70956945|NCT03541174|141417498|OTHER||LS Mean difference to placebo|-4.32|||<|0.0001|TWO_SIDED|95.0|-5.66|-2.98|||ANCOVA|||24-hour mean diastolic (DBP)||-2.98|-5.66|<0.0001
70956946|NCT03541174|141417498|OTHER||LS Mean|-5.81|||<|0.0001|TWO_SIDED|95.0|-7.14|-4.49|||ANCOVA|||24-hour mean diastolic (DBP)||-4.49|-7.14|<0.0001
70956947|NCT03541174|141417499|OTHER||LS Mean difference to placebo|-5.19|||<|0.0001|TWO_SIDED|95.0|-6.62|-3.76||Mixed effects model for Repeated Measures: Change from DB-WD baseline in SiDBP = Double-blind withdrawal baseline SiDBP + stratum (randomized treatment in DB part) + treatment + visit + treatment x visit + Double-blind withdrawal baseline x visit.|Mixed Models Analysis|||||-3.76|-6.62|<0.0001
70956948|NCT03541174|141417500|OTHER||LS Mean difference to placebo|-6.53|||<|0.0001|TWO_SIDED|95.0|-8.5|-4.56|||ANCOVA|||24-hour mean systolic (SBP)||-4.56|-8.50|<0.0001
70956949|NCT03541174|141417500|OTHER||LSM Mean difference to placebo|-6.75|||<|0.0001|TWO_SIDED|95.0|-7.98|-5.52|||ANCOVA|||24-hour mean diastolic (DBP)||-5.52|-7.98|<0.0001
70876557|NCT00514540|141236796|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.005|ONE_SIDED|95.0||||"Stoppage of trial early if 1) probability of response with the frontline treatment DC in the 1st 2 courses is unacceptably low compared to a target of 30% Pr(p1\*p2 \> .30\|data) \< 0.005, or 2) risk of a SAE is unacceptably high Pr(m \> m\* \|data) \< 0.001"|Bayesian probability model|Operating Characteristics of futility monitoring rule 1 \& safety monitoring rule 2 applied simultaneously for frontline treatment DC in courses 1 \& 2.||Disease status evaluated at the end of course 1 \& the end of course 2. Primary outcomes are response, defined as the absence of disease progression, and the time to a serious adverse event (SAE), defined as grade 3 or 4 neurotoxicity or death. Bayesian probability model \& decision rules used to monitor patient outcomes.||||< 0.005
70876558|NCT01896531|141236805|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|1.12|||=|0.56|TWO_SIDED|90.0|0.81|1.55|||Log Rank|||All randomized participants||1.55|0.81|= 0.56
70876559|NCT01896531|141236805|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|1.07|||=|0.86|TWO_SIDED|90.0|0.54|2.11|||Log Rank|||Participants with PTEN loss tumors||2.11|0.54|= 0.86
70876560|NCT01896531|141236806|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|1.52|||=|0.0234|TWO_SIDED|90.0|1.12|2.07|||Log Rank|||All randomized participants||2.07|1.12|= 0.0234
70876561|NCT01896531|141236806|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|1.66|||=|0.2867|TWO_SIDED|90.0|0.75|3.65|||Log Rank|||Participants with PTEN loss tumors||3.65|0.75|= 0.2867
70876562|NCT01896531|141236806|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|1.66|||=|0.1369|TWO_SIDED|90.0|0.94|2.93|||Log Rank|||Participants who are Akt Dx+||2.93|0.94|= 0.1369
70876563|NCT01896531|141236807|SUPERIORITY||Difference in Response Rates|-5.2|||=|0.5202|TWO_SIDED|90.0|-18.46|8.06|||Cochran-Mantel-Haenszel|||All randomized participants||8.06|-18.46|= 0.5202
70876564|NCT01896531|141236807|SUPERIORITY||Difference in Response Rates|-23.33|||=|0.2035|TWO_SIDED|90.0|-52.24|5.58|||Cochran-Mantel-Haenszel|||Participants with PTEN loss tumors||5.58|-52.24|= 0.2035
70876565|NCT01896531|141236807|SUPERIORITY||Difference in Response Rates|-4.35|||=|0.7697|TWO_SIDED|90.0|-28.48|19.79|||Cochran-Mantel-Haenszel|||Participants who are Akt Dx+||19.79|-28.48|= 0.7697
70876566|NCT01896531|141236808|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|1.14|||=|0.5974|TWO_SIDED|90.0|0.76|1.73|||Log Rank|||All randomized participants||1.73|0.76|= 0.5974
70876567|NCT01896531|141236808|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.71|||=|0.5385|TWO_SIDED|90.0|0.28|1.79|||Log Rank|||Participants with PTEN loss tumors||1.79|0.28|= 0.5385
70876568|NCT01896531|141236808|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.78|||=|0.6097|TWO_SIDED|90.0|0.35|1.75|||Log Rank|||Participants who are Akt Dx+||1.75|0.35|= 0.6097
70876569|NCT00533845|141236816|SUPERIORITY_OR_OTHER|||||||0.0022|TWO_SIDED||||||t-test, 2 sided|||||||.0022
70876570|NCT02956486|141236817|SUPERIORITY||Least Square (LS) Mean Difference|-0.17||||0.385|TWO_SIDED|95.0|-0.57|0.22|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (mild cognitive impairment \[MCI\]/Prodromal, mild alzheimer's disease \[AD\]), concurrent AD medication use, region, apolipoprotein E (ApoE4) status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.22|-0.57|0.385
70876571|NCT02956486|141236819|SUPERIORITY||LS Mean Difference|-0.02||||0.345|TWO_SIDED|95.0|-0.06|0.02|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.02|-0.06|0.345
70956950|NCT02217332|141417503|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|Paired t-test comparing baseline to month 6 on log scale within the dexpramipexole treatment group.||Null hypothesis is the ratio of Month 6 to Baseline within the dexpramipexole group equals '1'.||||< 0.001
70876572|NCT02956486|141236820|SUPERIORITY||LS Mean Difference|-12.83|||<|0.001|TWO_SIDED|95.0|-18.79|-6.88|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||-6.88|-18.79|<.001
70876573|NCT02956486|141236821|SUPERIORITY||LS Mean Difference|-0.23||||0.316|TWO_SIDED|95.0|-0.67|0.22|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.22|-0.67|0.316
70876574|NCT02956486|141236822|SUPERIORITY||LS Mean Difference|-0.03||||0.254|TWO_SIDED|95.0|-0.07|0.02|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.02|-0.07|0.254
70876575|NCT02956486|141236823|SUPERIORITY||Difference of Mean Slope|-0.008||||0.9088|TWO_SIDED|95.0|-0.145|0.129|||Linear mixed effects model|||Based on the linear mixed effects model, which included assessment time and treatment group by assessment time interaction as covariate with random intercept and slope.||0.129|-0.145|0.9088
70876576|NCT02956486|141236824|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.6155|TWO_SIDED|95.0|0.77|1.16|||Regression, Cox|||Based on a Cox regression model which included treatment group, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, APOE4 status (positive, negative) as covariate.||1.16|0.77|0.6155
70876577|NCT02956486|141236825|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.1281|TWO_SIDED|95.0|0.96|1.35|||Regression, Cox|||Based on a Cox regression model which included treatment group, concurrent AD medication use, region, APOE4 status (positive, negative) as covariate.||1.35|0.96|0.1281
70956951|NCT02217332|141417504|SUPERIORITY|||||||0.885||||||Month 6/LOCF was used for the analysis of change from Baseline to Month 6 within the dexpramipexole group.|t-test, 2 sided|||||||0.885
70956952|NCT02217332|141417508|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|Paired t-test comparing baseline to month 3 on log scale within the dexpramipexole treatment group.||Null hypothesis is the ratio of Month 3 to Baseline within the dexpramipexole group equals '1'.||||<.001
70956953|NCT02217332|141417509|SUPERIORITY|||||||1||||||Month 3/LOCF was used for the analysis of change from Baseline to Month 3 within the dexpramipexole group.|t-test, 2 sided|Paired t-test comparing baseline to month 3 within the dexpramipexole treatment group||||||1.0
70876578|NCT02956486|141236826|SUPERIORITY||LS Mean Difference|-0.43||||0.525|TWO_SIDED|95.0|-1.75|0.9|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.90|-1.75|0.525
70876579|NCT02956486|141236827|SUPERIORITY||LS Mean Difference|-0.01||||0.977|TWO_SIDED|95.0|-0.64|0.62|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.62|-0.64|0.977
70876580|NCT02956486|141236828|SUPERIORITY||LS Mean Difference|0.11||||0.854|TWO_SIDED|95.0|-1.09|1.32|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||1.32|-1.09|0.854
70876581|NCT02956486|141236829|SUPERIORITY||LS Mean Difference|-0.27||||0.314|TWO_SIDED|95.0|-0.79|0.26|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.26|-0.79|0.314
70956954|NCT02217332|141417510|SUPERIORITY||log scale|||||0.001|||||||Wilcoxon Signed Rank Test (paired)|||Null hypothesis is the ratio of Month 6 to Baseline within the dexpramipexole group equals '1'; 68% confidence interval is equal to plus/minus 1 standard error||||0.001
70876582|NCT02956486|141236830|SUPERIORITY||LS Mean Difference|0.07||||0.895|TWO_SIDED|95.0|-0.93|1.07|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||1.07|-0.93|0.895
70876583|NCT02956486|141236831|SUPERIORITY||LS Mean Difference|0.04||||0.542|TWO_SIDED|95.0|-0.09|0.17|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value as covariate.||0.17|-0.09|0.542
70876584|NCT02956486|141236832|SUPERIORITY||LS Mean Difference|-0.01||||0.38|TWO_SIDED|95.0|-0.02|0.01|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value as covariate.||0.01|-0.02|0.380
70876585|NCT02956486|141236833|SUPERIORITY||LS Mean Difference|-0.4||||0.063|TWO_SIDED|95.0|-0.82|0.02|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value as covariate.||0.02|-0.82|0.063
70876586|NCT02956486|141236834|SUPERIORITY||LS Mean Difference|-0.56||||0.045|TWO_SIDED|95.0|-1.11|-0.01|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value as covariate.||-0.01|-1.11|0.045
70876587|NCT02956486|141236835|SUPERIORITY||LS Mean Difference|-0.04||||0.799|TWO_SIDED|95.0|-0.32|0.24|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value as covariate.||0.24|-0.32|0.799
70876588|NCT02956486|141236836|SUPERIORITY||LS Mean Difference|-0.32||||0.012|TWO_SIDED|95.0|-0.56|-0.07|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value as covariate.||-0.07|-0.56|0.012
70876589|NCT01846611|141236849|SUPERIORITY||Hazard Ratio (HR)|0.925|||=|0.5236|TWO_SIDED|95.0|0.727|1.177|||Unstratified log rank test|||||1.177|0.727|= 0.5236
70876590|NCT01846611|141236850|SUPERIORITY||Hazard Ratio (HR)|0.935|||=|0.5174|TWO_SIDED|95.0|0.762|1.147|||Unstratified log rank test|||||1.147|0.762|= 0.5174
70876591|NCT01846611|141236851|SUPERIORITY||Odds Ratio (OR)|1.523|||=|0.0142|TWO_SIDED|95.0|1.075|2.158|||Fisher Exact|||||2.158|1.075|= 0.0142
70876592|NCT02671422|141236854|OTHER||1 year-survival rate|0.342|||||TWO_SIDED|95.0|0.0|0.894|||||Confidence interval is computed based on the LOGLOG method.|||0.894|0.000|
70876593|NCT04772755|141236855|SUPERIORITY|||||||0.0249|||||||Chi-squared|||||||0.0249
70876594|NCT04772755|141236856|SUPERIORITY|||||||0.8918|||||||Mantel Haenszel|||||||0.8918
70876595|NCT04772755|141236857|SUPERIORITY|||||||0.6587|||||||Wilcoxon (Mann-Whitney)|||||||0.6587
70876596|NCT04772755|141236858|SUPERIORITY|||||||0.0059|||||||Wilcoxon (Mann-Whitney)|||||||0.0059
70876597|NCT04772755|141236859|SUPERIORITY|||||||0.1647|||||||Chi-squared|||||||0.1647
70876598|NCT04772755|141236860|SUPERIORITY|||||||0.009|||||||Chi-squared|||||||0.0090
70876599|NCT04772755|141236861|SUPERIORITY|||||||0.0273|||||||Wilcoxon (Mann-Whitney)|||||||0.0273
70876600|NCT04772755|141236862|SUPERIORITY|||||||0.0458|||||||Chi-squared|||||||0.0458
70876601|NCT04772755|141236863|SUPERIORITY|||||||0.0976|||||||Chi-squared|||||||0.0976
70876602|NCT01905657|141236868|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.54||||0.00024|TWO_SIDED|95.0|0.38|0.77|||Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with strongly PD-L1 positive tumors||0.77|0.38|0.00024
70876603|NCT01905657|141236868|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.5||||2e-05|TWO_SIDED|95.0|0.36|0.7|||Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with strongly PD-L1 positive tumors||0.70|0.36|0.00002
70876604|NCT01905657|141236868|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.71||||0.00076|TWO_SIDED|95.0|0.58|0.88|||Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with PD-L1 positive tumors||0.88|0.58|0.00076
70876605|NCT01905657|141236868|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.61|||<|1e-05|TWO_SIDED|95.0|0.49|0.75|||Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with PD-L1 positive tumors||0.75|0.49|<0.00001
70876606|NCT01905657|141236869|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.58||||9e-05|TWO_SIDED|95.0|0.43|0.77|||Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with strongly PD-L1 positive tumors||0.77|0.43|0.00009
70876607|NCT01905657|141236869|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.59||||7e-05|TWO_SIDED|95.0|0.45|0.78|||Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with strongly PD-L1 positive tumors||0.78|0.45|0.00007
70956955|NCT02480153|141417533|NON_INFERIORITY_OR_EQUIVALENCE|Confidence interval (CIs) calculated by the score statistic method were used for the inference of the equivalence for ACR20 at Week 12. Therapeutic equivalence could be established if the 2-sided 95% CI fell within (-14%, 14%). Non-responder imputation was applied. Comparisons between treatments were computed as PF-06410293 versus Adalimumab-EU.|Week 12 ACR20 response rate difference|-2.98|||||TWO_SIDED|95.0|-10.38|4.44||||||||4.44|-10.38|
70956956|NCT02480153|141417533|NON_INFERIORITY_OR_EQUIVALENCE|Confidence interval (CIs) calculated by the score statistic method were used for the inference of the equivalence for ACR20 at Week 12. Therapeutic equivalence could be established if 2-sided 90% CI fell within (-12%, 15%). Non-responder imputation was applied. Comparisons between treatments were computed as PF-06410293 versus Adalimumab-EU.|Week 12 ACR20 response rate difference|-2.98|||||TWO_SIDED|90.0|-9.25|3.28||||||||3.28|-9.25|
70876608|NCT01905657|141236869|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.88||||0.06758|TWO_SIDED|95.0|0.73|1.04|||Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with PD-L1 positive tumors||1.04|0.73|0.06758
70876609|NCT01905657|141236869|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.79||||0.00462|TWO_SIDED|95.0|0.66|0.94|||Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with PD-L1 positive tumors||0.94|0.66|0.00462
70876610|NCT01905657|141236872|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|-2.3||||0.66608|TWO_SIDED|95.0|-12.7|8.2||P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage not equal to 0, in accordance with the statistical analysis plan.|Miettinen & Nurminen method||This is an adjusted risk difference estimated by stratified Miettinen \& Nurminen method.|In participants with strongly PD-L1 positive tumors||8.2|-12.7|0.66608
70956957|NCT04433585|141417594|SUPERIORITY||Odds Ratio (OR)|1.46||||0.309|TWO_SIDED|95.0|0.7|3.04|||Regression, Logistic|||||3.04|0.70|0.309
70956958|NCT04433585|141417594|SUPERIORITY||Odds Ratio (OR)|0.97||||0.944|TWO_SIDED|95.0|0.47|2.03|||Regression, Logistic|||||2.03|0.47|0.944
70876611|NCT01905657|141236872|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|22.2|||<|1e-05|TWO_SIDED|95.0|14.0|30.7||P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage greater than 0, in accordance with the statistical analysis plan.|Miettinen & Nurminen method||This is an adjusted risk difference estimated by stratified Miettinen \& Nurminen method.|In participants with strongly PD-L1 positive tumors||30.7|14.0|<0.00001
70876612|NCT01905657|141236872|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|8.7||||0.00045|TWO_SIDED|95.0|3.6|13.9||P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage greater than 0, in accordance with the statistical analysis plan.|Miettinen & Nurminen method||This is an adjusted risk difference estimated by stratified Miettinen \& Nurminen method.|In participants with PD-L1 positive tumors||13.9|3.6|0.00045
70876613|NCT01905657|141236872|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|9.1||||0.00024|TWO_SIDED|95.0|4.1|14.3||P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage greater than 0, in accordance with the statistical analysis plan.|Miettinen & Nurminen method||This is an adjusted risk difference estimated by stratified Miettinen \& Nurminen method.|In participants with PD-L1 positive tumors||14.3|4.1|0.00024
70876614|NCT04702997|141236902|SUPERIORITY||LS Mean difference (Net)|7.71|STANDARD_ERROR_OF_MEAN|1.268|<|0.0001|TWO_SIDED|95.0|5.18|10.24||KDIGO strata, treatment group, time (Week 1 to 12), and the interaction between treatment and time were used as fixed factors.|Mixed Models Analysis||Difference is bardoxolone methyl - placebo|||10.24|5.18|<0.0001
70876615|NCT00157950|141237098|SUPERIORITY_OR_OTHER||Proportion|98.2|||||TWO_SIDED|95.0|93.6|99.8|||||Exact binomial confidence interval|||99.8|93.6|
70956959|NCT04433585|141417594|SUPERIORITY||Odds Ratio (OR)|0.84||||0.649|TWO_SIDED|95.0|0.4|1.78|||Regression, Logistic|||||1.78|0.40|0.649
70876616|NCT00157950|141237099|NON_INFERIORITY_OR_EQUIVALENCE|The lower bound of the 95% confidence interval for the proportion of subjects receiving Gardasil who were seropositive at Week 4 postdose 3 must be greater than 90%|Proportion|100.0|||||TWO_SIDED|95.0|96.8|100.0|||||Exact binomial confidence interval|||100|96.8|
70876617|NCT00157950|141237100|NON_INFERIORITY_OR_EQUIVALENCE|The lower bound of the 95% confidence interval for the proportion of subjects receiving Gardasil who were seropositive at Week 4 postdose 3 must be greater than 90%|Proportion|99.1|||||TWO_SIDED|95.0|95.2|100.0|||||Exact binomial confidence interval|||100|95.2|
70956960|NCT04433585|141417595|SUPERIORITY||Odds Ratio (OR)|1.89||||0.131|TWO_SIDED|95.0|0.83|4.3|||Regression, Logistic|||||4.30|0.83|0.131
70956961|NCT04433585|141417595|SUPERIORITY||Odds Ratio (OR)|1.09||||0.844|TWO_SIDED|95.0|0.47|2.5|||Regression, Logistic|||||2.50|0.47|0.844
70956962|NCT04433585|141417595|SUPERIORITY||Odds Ratio (OR)|0.57||||0.218|TWO_SIDED|95.0|0.24|1.39|||Regression, Logistic|||||1.39|0.24|0.218
70956963|NCT04433585|141417596|SUPERIORITY||Odds Ratio (OR)|0.97||||0.944|TWO_SIDED|95.0|0.47|2.03|||Regression, Logistic|||||2.03|0.47|0.944
70956964|NCT04433585|141417596|SUPERIORITY||Odds Ratio (OR)|1.46||||0.309|TWO_SIDED|95.0|0.7|3.04|||Regression, Logistic|||||3.04|0.70|0.309
70876618|NCT00157950|141237101|NON_INFERIORITY_OR_EQUIVALENCE|The lower bound of the 95% confidence interval for the proportion of subjects receiving Gardasil who were seropositive at Week 4 postdose 3 must be greater than 90%|Proportion|99.1|||||TWO_SIDED|95.0|95.0|100.0|||||Exact binomial confidence interval|||100|95.0|
70876619|NCT02259582|141237170|SUPERIORITY|Based on RECIST v1.1. Response outcomes from an assessment done anytime less than Day 35 were considered as not evaluable unless the response assessment was progress disease.|Hazard Ratio (HR)|0.04|||=|0.0401|TWO_SIDED|95.0|0.013|0.095|||Log Rank|||The Kaplan-Meier method was used to estimate both the survival curves and the median survival time. The 95% confidence interval (CI) for the median survival time was calculated. A p-value for treatment effect was generated using a stratified Cox proportional hazards model.||.095|.013|=0.0401
70876620|NCT02436889|141237201|SUPERIORITY|||||||0.949|||||||ANCOVA|||||||0.949
70876621|NCT02436889|141237202|SUPERIORITY||Mean Difference (Final Values)|3.11||||0.2415|TWO_SIDED|95.0|-2.09|8.31|||ANCOVA|change from baseline, adjusted for baseline value||||8.31|-2.09|0.2415
70876622|NCT02436889|141237203|SUPERIORITY||Mean Difference (Final Values)|-12.01||||0.0001|TWO_SIDED|95.0|-18.16|-5.87|||ANCOVA|||||-5.87|-18.16|0.0001
70876623|NCT02436889|141237204|SUPERIORITY||Mean Difference (Final Values)|-0.63||||0.1956|TWO_SIDED|95.0|-1.59|0.33|||ANCOVA|||||0.33|-1.59|0.1956
70876624|NCT02436889|141237205|SUPERIORITY||Mean Difference (Final Values)|1.87||||0.0168|TWO_SIDED|95.0|0.34|3.4|||ANCOVA|||||3.40|0.34|0.0168
70876625|NCT02436889|141237206|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.0101|TWO_SIDED|95.0|0.5|3.71|||ANCOVA|||||3.71|0.50|0.0101
70876626|NCT01034462|141237207|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.095||||0.0051|TWO_SIDED|95.0|-5.256|-0.935|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-0.935|-5.256|0.0051
70876627|NCT01034462|141237208|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.632||||0.001|TWO_SIDED|95.0|-4.193|-1.07|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-1.070|-4.193|0.0010
70876628|NCT02618434|141237225|SUPERIORITY||Median Difference (Net)|-0.56||||0.9383|TWO_SIDED|95.0|-8.96|7.84|||Wilcoxon (Mann-Whitney)|||||7.84|-8.96|0.9383
70876629|NCT02618434|141237226|SUPERIORITY||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.0979|TWO_SIDED|95.0|-0.33|0.03|||Mixed Models Analysis|||This analysis pertains to Visit 4||0.03|-0.33|0.0979
70876630|NCT02618434|141237226|SUPERIORITY||Mean Difference (Net)|-0.25|STANDARD_ERROR_OF_MEAN|0.126||0.0502|TWO_SIDED|95.0|-0.5|0.0|||Mixed Models Analysis|||This analysis pertains to Visit 5||0.00|-0.50|0.0502
70876631|NCT02618434|141237226|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.141||0.4769|TWO_SIDED|95.0|-0.38|0.18|||Mixed Models Analysis|||This analysis pertains to Visit 6||0.18|-0.38|0.4769
70876632|NCT02618434|141237227|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.113||0.0881|TWO_SIDED|95.0|-0.41|0.03|||Mixed Models Analysis|||This analysis pertains to Visit 4||0.03|-0.41|0.0881
70876633|NCT02618434|141237227|SUPERIORITY||Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.135||0.0522|TWO_SIDED|95.0|-0.53|0.0|||Mixed Models Analysis|||This analysis pertains to Visit 5||0.00|-0.53|0.0522
70876634|NCT02618434|141237227|SUPERIORITY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.156||0.1766|TWO_SIDED|95.0|-0.52|0.1|||Mixed Models Analysis|||This analysis pertains to Visit 6||0.10|-0.52|0.1766
70876635|NCT02618434|141237228|SUPERIORITY||Mean Difference (Net)|1.54|STANDARD_ERROR_OF_MEAN|1.613||0.3409|TWO_SIDED|95.0|-1.64|4.72|||ANCOVA|||This analysis pertains to the Physical Functioning Summary Score at Visit 6.||4.72|-1.64|0.3409
70876636|NCT02618434|141237228|SUPERIORITY||Mean Difference (Net)|-2.21|STANDARD_ERROR_OF_MEAN|0.952||0.0215|TWO_SIDED|95.0|-4.08|-0.33|||ANCOVA|||This analysis pertains to the Psychosocial Health Summary Score at Visit 6.||-0.33|-4.08|0.0215
70876637|NCT02618434|141237229|SUPERIORITY||Mean Difference (Net)|-1.06|STANDARD_ERROR_OF_MEAN|2.0||0.5977|TWO_SIDED|95.0|-5.0|2.89|||ANCOVA|||This analysis pertains to the Total Score at Visit 6.||2.89|-5.00|0.5977
70876638|NCT02618434|141237229|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.807||0.8049|TWO_SIDED|95.0|-1.39|1.79|||ANCOVA|||This analysis pertains to the Parental Distress Domain score at Visit 6.||1.79|-1.39|0.8049
70876639|NCT02618434|141237229|SUPERIORITY||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.801||0.8911|TWO_SIDED|95.0|-1.47|1.69|||ANCOVA|||This analysis pertains to the Parent-Child Dysfunctional Interaction score at Visit 6.||1.69|-1.47|0.8911
70876640|NCT02618434|141237229|SUPERIORITY||Mean Difference (Net)|-1.25|STANDARD_ERROR_OF_MEAN|0.849||0.1426|TWO_SIDED|95.0|-2.93|0.42|||ANCOVA|||This analysis pertains to the Difficult Child Domain score Visit 6.||0.42|-2.93|0.1426
70876641|NCT02618434|141237230|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.134||0.6171|TWO_SIDED|95.0|-0.33|0.2|||Mixed Models Analysis|||This analysis pertains to Visit 4||0.20|-0.33|0.6171
70876642|NCT02618434|141237230|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.143||0.0617|TWO_SIDED|95.0|-0.55|0.01|||Mixed Models Analysis|||This analysis pertains to Visit 5||0.01|-0.55|0.0617
70876643|NCT02618434|141237230|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.171||0.4419|TWO_SIDED|95.0|-0.47|0.21|||Mixed Models Analysis|||This analysis pertains to Visit 6||0.21|-0.47|0.4419
70876644|NCT02618434|141237231|SUPERIORITY||Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.0416|TWO_SIDED|95.0|-0.32|-0.01|||ANCOVA|||This analysis pertains to the Inattention subscale at Visit 6.||-0.01|-0.32|0.0416
70876645|NCT02618434|141237231|SUPERIORITY||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.089||0.0921|TWO_SIDED|95.0|-0.33|0.02|||ANCOVA|||This analysis pertains to Hyperactivity/Impulsivity subscale at Visit 6||0.02|-0.33|0.0921
70876646|NCT02618434|141237231|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.094||0.448|TWO_SIDED|95.0|-0.26|0.11|||ANCOVA|||This analysis pertains to the Oppositional Defiant Disorder subscale at Visit 6||0.11|-0.26|0.4480
70876647|NCT02618434|141237231|SUPERIORITY||Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.077||0.0457|TWO_SIDED|95.0|-0.31|0.0|||ANCOVA|||This analysis pertains to the Combined Scale score at Visit 6||-0.00|-0.31|0.0457
70876648|NCT02618434|141237232|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8525|TWO_SIDED|95.0|0.58|1.93|||Regression, Logistic|||This analysis pertains to ≥ 30% Responders.||1.93|0.58|0.8525
70956965|NCT04433585|141417596|SUPERIORITY||Odds Ratio (OR)|0.84||||0.649|TWO_SIDED|95.0|0.4|1.78|||Regression, Logistic|||||1.78|0.40|0.649
70876649|NCT02618434|141237232|SUPERIORITY||Odds Ratio (OR)|0.89||||0.6635|TWO_SIDED|95.0|0.52|1.51|||Regression, Logistic|||This analysis pertains to ≥ 50% Responders.||1.51|0.52|0.6635
70876650|NCT02135146|141237262|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||||||0.31
70876651|NCT02135146|141237262|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
70876652|NCT00345254|141237294|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
70876653|NCT01860651|141237372|OTHER||mean difference over time|-0.002||||0.22|TWO_SIDED|95.0|-0.005|0.001|||Mixed Effect Model|||"Statistical analysis of Medical adherence in study Medication adm. at home were analysed using a Mixed Effect Model (MEM). The MEM model included a random patient effect and a fixed effect interaction between group and time, to evaluate difference between the groups over time."||0.001|-0.005|0.22
70956966|NCT04433585|141417597|SUPERIORITY||Odds Ratio (OR)|1.91||||0.203|TWO_SIDED|95.0|0.71|5.2|||Regression, Logistic|||||5.20|0.71|0.203
70956967|NCT04433585|141417597|SUPERIORITY||Odds Ratio (OR)|1.1||||0.865|TWO_SIDED|95.0|0.38|3.16|||Regression, Logistic|||||3.16|0.38|0.865
70956968|NCT04433585|141417597|SUPERIORITY||Odds Ratio (OR)|1.07||||0.896|TWO_SIDED|95.0|0.38|3.05|||Regression, Logistic|||||3.05|0.38|0.896
70956969|NCT02630693|141417601|OTHER|As stated in the protocol, the primary objective of this trial is to estimate the hazard ratio and the corresponding 90% confidence interval. Therefore, we do not conduct any statistical hypothesis test for progression free survival.|Hazard Ratio (HR)|0.93|||||TWO_SIDED|90.0|0.66|1.3|||||Hazard ratio of Palbociclib100mg arm vs 125 mg arm|||1.30|0.66|
70956970|NCT02630693|141417604|OTHER|As stated in the protocol, the objective of this trial is to estimate the hazard ratio and the corresponding 90% confidence interval. Therefore, we do not conduct any statistical hypothesis test for overall survival.|Hazard Ratio (HR)|1.07|||||TWO_SIDED|90.0|0.67|1.69|||||Hazard ratio for Palbociclib 100mg arm vs 125 mg arm|||1.69|0.67|
70956971|NCT00952120|141417626|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Regression, Logistic|robust standard errors were used to account for the multiple observations per patient||||||0.80
70876654|NCT02663232|141237379|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of Melanoma Stage (IIIC \[referral category\] versus (vs) M1a vs M1b vs M1c) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.001
70876655|NCT02663232|141237379|SUPERIORITY_OR_OTHER_LEGACY|||||||0.196|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of Melanoma Stage IIIC/M1a/M1b \[referral category\] vs M1c with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.196
70876656|NCT02663232|141237379|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||Multivariate regression analysis|Multivariate regression analysis of clinical risk factors for BRAF mutation||The association of Melanoma Stage IIIc with the risk of BRAF mutation (Yes/No) was assessed using multivariate regression analysis.||||0.002
70876657|NCT02663232|141237379|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.716||||0.028|TWO_SIDED|95.0|1.115|6.616|||Multivariate regression analysis|Multivariate regression analysis of clinical risk factors for BRAF mutation (n=184)||The association of Melanoma Stage M1a (using Melanoma Stage IIIC as referral category) with the risk of BRAF mutation (Yes/No) was assessed using multivariate regression analysis.||6.616|1.115|0.028
70876658|NCT02663232|141237379|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.466||||0.142|TWO_SIDED|95.0|0.168|1.291|||Multivariate regression analysis|Multivariate regression analysis of clinical risk factors for BRAF mutation (n=184)||The association of Melanoma Stage M1b (using Melanoma Stage IIIC as referral category) with the risk of BRAF mutation (Yes/No) was assessed using multivariate regression analysis.||1.291|0.168|0.142
70956972|NCT02313233|141417635|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
70956973|NCT02313233|141417636|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
70956974|NCT02313233|141417639|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
70956975|NCT02313233|141417640|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
70956976|NCT01288521|141417697|SUPERIORITY|The null hypothesis is that the tacrolimus biovailability alone is equal to the tacrolimus bioavailability when given with ketoconazole.||||||0.006|||||||Regression, Linear|The bioavailability with Tac alone vs. Tac +keto was compared using linear model adjusting for sex and creatinine clearance.||The bioavailability of Tac alone vs. Tac +keto was compared using a general linear model including sex and creatinine clearance as covariates.||||0.006
70956977|NCT00682890|141417700|SUPERIORITY_OR_OTHER|||||||0.63|||||||ANOVA|||P value on change at 3 months for placebo group||||0.63
70956978|NCT00682890|141417700|SUPERIORITY_OR_OTHER|||||||0.42|||||||ANOVA|||||||0.42
70956979|NCT00682890|141417701|SUPERIORITY_OR_OTHER|||||||0.51|||||||ANOVA|||||||0.51
70956980|NCT00682890|141417701|SUPERIORITY_OR_OTHER|||||||0.03|||||||ANOVA|||||||0.03
70956981|NCT03028220|141417703|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
70956982|NCT03028220|141417704|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
70956983|NCT03028220|141417705|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
70956984|NCT03028220|141417706|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
70956985|NCT03028220|141417707|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
70956986|NCT03028220|141417708|OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.820
70956987|NCT03028220|141417709|OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.820
70956988|NCT03028220|141417710|OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.570
70956989|NCT03028220|141417711|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
70956990|NCT03028220|141417712|OTHER|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.910
70956991|NCT03028220|141417713|OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.460
70956992|NCT03028220|141417714|OTHER|||||||0.191|||||||Wilcoxon (Mann-Whitney)|||||||0.191
70956993|NCT02884908|141417715|SUPERIORITY|Based on randomization to treatment condition, the model assumed no differences at baseline (any difference was assumed due to random sampling error).||||||0.8|||||||Mixed Models Analysis|||||||0.80
70956994|NCT02884908|141417716|SUPERIORITY|Based on randomization to treatment condition, the model assumed no differences at baseline (any difference was assumed due to random sampling error).||||||0.9|||||||Mixed Models Analysis|||||||0.90
70956995|NCT02884908|141417717|SUPERIORITY|Based on randomization to treatment condition, the model assumed no differences at baseline (any difference was assumed due to random sampling error).||||||0.38|||||||Mixed Models Analysis|||||||0.38
70956996|NCT04493502|141417732|SUPERIORITY||Mean Difference (Final Values)|17.1||||0.189|TWO_SIDED|95.0|-7.3|41.4|||Regression, Logistic|||||41.4|-7.3|0.189
70956997|NCT04493502|141417733|SUPERIORITY||Mean Difference (Final Values)|-4.67||||0.024|TWO_SIDED|95.0|-8.69|-0.64|||ANCOVA|||||-0.64|-8.69|0.024
70956998|NCT04493502|141417734|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.949|TWO_SIDED|95.0|-1.44|1.53|||ANCOVA|||||1.53|-1.44|0.949
70956999|NCT02751320|141417738|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09||||0.7603|TWO_SIDED|95.0|-8.11|5.94||From ANCOVA: Participant (random), treatment \& period (fixed), subject-level baseline SMH, period-level baseline SMH, subject-level pre-treatment acid challenge SMH and period-level pre-treatment acid challenge SMH (covariates).|ANCOVA||Difference is first named treatment minus second named treatment such that positive difference favors the first named treatment.|||5.94|-8.11|0.7603
70957000|NCT02751320|141417738|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3||||0.3555|TWO_SIDED|95.0|-10.34|3.74||From ANCOVA: Participant (random), treatment \& period (fixed), subject-level baseline SMH, period-level baseline SMH, subject-level pre-treatment acid challenge SMH and period-level pre-treatment acid challenge SMH (covariates).|ANCOVA||Difference is first named treatment minus second named treatment such that positive difference favors the first named treatment.|||3.74|-10.34|0.3555
70957001|NCT02751320|141417738|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.21||||0.5335|TWO_SIDED|95.0|-4.81|9.23||ANCOVA: Participant (random), treatment \& period (fixed), Participant-level baseline SMH, period-level baseline SMH, Participant-level pre-treatment acid challenge SMH and period-level pre-treatment acid challenge SMH (covariates)|ANCOVA||Difference is first named treatment minus second named treatment such that positive difference favors the first named treatment.|||9.23|-4.81|0.5335
70957002|NCT02751320|141417738|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.96|||<|0.0001|TWO_SIDED|95.0|16.02|29.9||From ANCOVA: Participant (random), treatment \& period (fixed), Participant -level baseline SMH, period-level baseline SMH, Participant -level pre-treatment acidchallenge SMH and period-level pre-treatment acid challenge SMH (covariates) .|ANCOVA||Difference is first named treatment minus second named treatment such that positive difference favors the first named treatment.|Treatment comparison corresponding to qualifying criteria for the analysis||29.90|16.02|<.0001
70957003|NCT01942590|141417829|OTHER|||||||0.0512|||||||t-test, 1 sided|||||||0.0512
70957004|NCT01942590|141417829|OTHER|||||||0.434|||||||t-test, 1 sided|||||||0.434
70957005|NCT01942590|141417830|OTHER|||||||0.0816||||||Paired t test comparing each subject's performance at Week 52 to Baseline|t-test, 1 sided|||||||0.0816
70957006|NCT01942590|141417830|OTHER|||||||0.3318||||||Paired t test comparing each subject's performance at Week 52 to Baseline|t-test, 1 sided|||||||0.3318
70957007|NCT01942590|141417831|OTHER|||||||0.2074|||||||t-test, 1 sided|||||||0.2074
70957008|NCT01942590|141417831|OTHER|||||||0.332|||||||t-test, 1 sided|||||||0.332
70957009|NCT01942590|141417832|OTHER|||||||0.233||||||Paired t test comparing each subject's performance at Week 52 to Baseline|t-test, 1 sided|||||||0.233
70957010|NCT01942590|141417832|OTHER|||||||0.142||||||Paired t test comparing each subject's performance at Week 52 to Baseline|t-test, 1 sided|||||||0.142
70957011|NCT01942590|141417833|OTHER|||||||0.019|||||||t-test, 1 sided|||||||0.019
70957012|NCT01942590|141417833|OTHER|||||||0.366|||||||t-test, 1 sided|||||||0.366
70957013|NCT01942590|141417834|OTHER|||||||0.161|||||||t-test, 1 sided|||||||0.161
70957014|NCT01942590|141417834|OTHER|||||||0.43|||||||t-test, 1 sided|||||||0.43
70876659|NCT02663232|141237379|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.822||||0.653|TWO_SIDED|95.0|0.351|1.928|||Multivariate regression analysis|Multivariate regression analysis of clinical risk factors for BRAF mutation (n=184)||The association of Melanoma Stage M1c (using Melanoma Stage IIIC as referral category) with the risk of BRAF mutation (Yes/No) was assessed using multivariate regression analysis.||1.928|0.351|0.653
70876660|NCT02663232|141237380|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of Family family history of melanoma (yes vs no) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.240
70876661|NCT02663232|141237381|SUPERIORITY_OR_OTHER_LEGACY|||||||0.719|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of sun exposure yes vs no with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.719
70876662|NCT02663232|141237382|SUPERIORITY_OR_OTHER_LEGACY|||||||0.262|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of primary tumor site (trunk \[referral category\] vs head and neck vs upper extremities vs lower extremities vs. visceral/mucosa) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.262
70957015|NCT01942590|141417835|OTHER|||||||0.01|||||||t-test, 1 sided|||Baseline, week 18||||0.01
70957016|NCT01942590|141417835|OTHER|||||||0.004|||||||t-test, 1 sided|||Baseline, week 52||||0.004
70957017|NCT01942590|141417835|OTHER|||||||0.154|||||||t-test, 1 sided|||Baseline, week 18||||0.154
70957018|NCT01942590|141417835|OTHER|||||||0.211|||||||t-test, 1 sided|||Baseline, Week 52||||0.211
70957019|NCT01942590|141417836|OTHER|||||||0.006|||||||t-test, 1 sided|||Baseline, Week 18||||0.006
70957020|NCT01942590|141417836|OTHER|||||||0.007|||||||t-test, 1 sided|||Baseline, Week 52||||0.007
70957021|NCT01942590|141417836|OTHER|||||||0.297|||||||t-test, 1 sided|||Baseline, Week 18||||0.297
70957022|NCT01942590|141417836|OTHER|||||||0.196|||||||t-test, 1 sided|||Baseline, Week 52||||0.196
70957023|NCT01942590|141417837|OTHER|||||||0.3639|||||||t-test, 1 sided|||Baseline Week 18||||0.3639
70957024|NCT01942590|141417837|OTHER|||||||0.0371|||||||t-test, 1 sided|||Baseline, Week 52||||0.0371
70957025|NCT01942590|141417838|OTHER|||||||0.268|||||||t-test, 1 sided|||Baseline, Week 18||||0.268
70957026|NCT01942590|141417838|OTHER|||||||0.0036|||||||t-test, 1 sided|||Baseline, Week 52||||0.0036
70876663|NCT02663232|141237383|SUPERIORITY_OR_OTHER_LEGACY|||||||0.313|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of LDH (elevated \[referral category\] vs normal vs unknown) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.313
70876664|NCT02663232|141237384|SUPERIORITY_OR_OTHER_LEGACY|||||||0.291|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of time since diagnosis of primary melanoma (continuous variable) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.291
70957027|NCT01942590|141417838|OTHER|||||||0.286|||||||t-test, 1 sided|||Baseline, Week 18||||0.286
70876665|NCT02663232|141237385|SUPERIORITY_OR_OTHER_LEGACY|||||||0.164|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of tumor sample source (primary tumor \[referral category\] vs metastases vs relapses) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.164
70957028|NCT01942590|141417838|OTHER|||||||0.279|||||||t-test, 1 sided|||Baseline, Week 52||||0.279
70957029|NCT01942590|141417839|OTHER|||||||0.479|||||||t-test, 1 sided|||Baseline, Week 18||||0.479
70957030|NCT01942590|141417839|OTHER|||||||0.059|||||||t-test, 1 sided|||Baseline, Week 52||||0.059
70957031|NCT01942590|141417839|OTHER|||||||0.152|||||||t-test, 1 sided|||Baseline, Week 18||||0.152
70957032|NCT01942590|141417839|OTHER|||||||0.118|||||||t-test, 1 sided|||Baseline, Week 52||||0.118
70957033|NCT01226095|141418027|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
70876666|NCT02663232|141237386|SUPERIORITY_OR_OTHER_LEGACY|||||||0.505|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of tumor sample type (paraffin-embedded blocks \[referral category\] vs slides of paraffin blocks vs cytology slides) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.505
70957034|NCT00857272|141418036|NON_INFERIORITY_OR_EQUIVALENCE|Fifteen percent has been established as an acceptable non-inferiority margin for evaluation of investigational bowel preparations in previous studies of FDA approved preparations (e.g. NuLytely, MoviPrep).|Difference in success rates|-2.5||||0.005|TWO_SIDED|95.0|-11.9|6.8|||Chi-squared|||"The primary endpoint of preparation success was tested using a non-inferiority test based upon the difference D=P1-P2,~Null Hypothesis H0: P1-P2\<=D0 versus Alternative Hypothesis H1: P1-P2=D1\>D0,~Where P1 is the % of patients with successful preps in the HalfLytely 5mg group and P2 is the % of patients with successful preps in the HalfLytely 10mg group and D0 is the acceptable margin of equivalence equal to an absolute margin of 15%."||6.8|-11.9|0.005
70876667|NCT02663232|141237387|SUPERIORITY_OR_OTHER_LEGACY|||||||0.701|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of method of fixation (buffered formalin \[referral category\] vs other) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.701
70876668|NCT02663232|141237388|SUPERIORITY_OR_OTHER_LEGACY|||||||0.683|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of Berslow thickness (≤1 mm \[referral category\] vs 1.01-2 mm vs 2.01-4 mm vs 4 mm) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.683
70876669|NCT02663232|141237389|SUPERIORITY_OR_OTHER_LEGACY|||||||0.615|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of Ulceration (no \[referral category\] vs yes) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.615
70876670|NCT02663232|141237390|SUPERIORITY_OR_OTHER_LEGACY|||||||0.949|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of presence of regression (Without regression \[referral category\] vs With regression) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.949
70876671|NCT02663232|141237391|SUPERIORITY_OR_OTHER_LEGACY|||||||0.374|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of Vascular invasion (Without vascular invasion \[referral category\] vs With vascular invasion) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.374
70876672|NCT00862745|141237399|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No adjustment for multiple comparisons, threshold for significance is P \< .05|ANCOVA|Mean difference=Drug A minus Drug B||Null hypothesis: fesoterodine treatment is not associated with greater reduction in urgency incontinence frequency compared to placebo in women diagnosed using the 3IQ||||<0.001
70876673|NCT00110149|141237413|OTHER|As the study was not able to be completed the simple number of patients per outcome is listed.|||||||||||||||||The trial was to measure the response rate and EFS of patients but the manufacturer of the investigational agent closed and sold the agent to a new company so the trial was not able to be completed.|||
70876674|NCT00563381|141237415|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83|||<|0.0001||95.0|0.77|0.9|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.90|0.77|<0.0001
70876675|NCT00563381|141237416|SUPERIORITY_OR_OTHER||Rate ratio (ratio of incidence rates)|0.73|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.66|0.82|||Poisson regression|Poisson regression correcting for overdisperion and adjusted for treatment exposure||Tiotropium vs. Salmeterol||0.82|0.66|<0.0001
70876676|NCT00563381|141237417|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9||||0.0002||95.0|0.85|0.95|||Cochran-Mantel-Haenszel|||Tiotropium versus Salmeterol||0.95|0.85|0.0002
70876677|NCT00563381|141237418|SUPERIORITY_OR_OTHER||Rate ratio (ratio of incidence rates)|0.89|STANDARD_ERROR_OF_MEAN|0.03||0.0017||95.0|0.83|0.96|||Poisson regression|Poisson regression correcting for overdisperion and adjusted for treatment exposure||Tiotropium versus Salmeterol||0.96|0.83|0.0017
70876678|NCT00563381|141237419|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|||<|0.0001||95.0|0.61|0.85|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.85|0.61|<0.0001
70876679|NCT00563381|141237420|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77||||0.0005||95.0|0.66|0.89|||Cochran-Mantel-Haenszel|||Tiotropium versus Salmeterol||0.89|0.66|0.0005
70876680|NCT00563381|141237421|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.0242||95.0|0.78|0.98|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.98|0.78|0.0242
70876681|NCT00563381|141237422|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9||||0.0406||95.0|0.82|1.0|||Cochran-Mantel-Haenszel|||Tiotropium versus Salmeterol||1.00|0.82|0.0406
70876682|NCT00563381|141237423|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84|||<|0.0001||95.0|0.78|0.91|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.91|0.78|<0.0001
70876683|NCT00563381|141237424|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77|||<|0.0001||95.0|0.69|0.85|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.85|0.69|<0.0001
70876684|NCT00563381|141237425|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85|||<|0.0001||95.0|0.78|0.92|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.92|0.78|<0.0001
70876685|NCT00563381|141237426|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76|||<|0.0001||95.0|0.68|0.86|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.86|0.68|<0.0001
70876686|NCT00563381|141237427|SUPERIORITY_OR_OTHER||Rate ratio (ratio of incidence rates)|0.82|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.76|0.9|||Poisson regression|Poisson regression correcting for overdispersion and adjusted for treatment exposure||Tiotropium versus Salmeterol||0.90|0.76|<0.0001
70876687|NCT00563381|141237428|SUPERIORITY_OR_OTHER||Rate ratio (ratio of incidence rates)|0.9|STANDARD_ERROR_OF_MEAN|0.03||0.0036||95.0|0.84|0.97|||Poisson regression|Poisson regression correcting for overdisperion and adjusted for treatment exposure||Tiotropium versus Salmeterol||0.97|0.84|0.0036
70876688|NCT00563381|141237429|SUPERIORITY_OR_OTHER||Rate ratio (ratio of incidence rates)|0.8|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.73|0.88|||Poisson regression|Poisson regression correcting for overdisperion and adjusted for treatment exposure||Tiotropium versus Salmeterol||0.88|0.73|<0.0001
70876689|NCT00563381|141237430|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.6||||0.1035||95.0|-3.53|0.33|||Mixed Effects Repeated Measures Model|Mixed effects repeated measures model (MMRM) (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.33|-3.53|0.1035
70876690|NCT00563381|141237431|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-2.06||||0.0369||95.0|-3.99|-0.12|||Mixed Effects Repeated Measures Model|Mixed effects repeated measures model (MRMM)(fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week).||Tiotropium versus Salmeterol||-0.12|-3.99|0.0369
70876691|NCT00563381|141237432|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-2.07||||0.0362||95.0|-4.0|-0.13|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||-0.13|-4.00|0.0362
70876692|NCT00563381|141237433|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.88||||0.0573||95.0|-3.82|0.06|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.06|-3.82|0.0573
70876693|NCT00563381|141237434|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.1||||0.2641||95.0|-3.04|0.83|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.83|-3.04|0.2641
70876694|NCT00563381|141237435|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.01||||0.3068||95.0|-2.95|0.93|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.93|-2.95|0.3068
70876695|NCT00563381|141237436|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.78||||0.4299||95.0|-2.72|1.16|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||1.16|-2.72|0.4299
70957035|NCT01285609|141418061|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.907||||0.2517|TWO_SIDED|95.0|0.767|1.072|||Log Rank|p-value based on an unstratified 2-sided log rank test|Hazard of Ipilimumab over Hazard of Placebo with 2-sided 95% confidence intervals are based on an unstratified Cox proportional hazards model with treatment as the single covariate|Hazard ratio = Ipilimumab with Paclitaxel/Carboplatin over Placebo with Paclitaxel/Carboplatin||1.072|0.767|0.2517
70876696|NCT00563381|141237437|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.48||||0.6277||95.0|-2.42|1.46|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||1.46|-2.42|0.6277
70876697|NCT00563381|141237438|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.85||||0.3931||95.0|-2.8|1.1|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||1.10|-2.80|0.3931
70876698|NCT00563381|141237439|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.97||||0.3297||95.0|-2.92|0.98|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.98|-2.92|0.3297
70876699|NCT00563381|141237440|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.3||||0.1904||95.0|-3.25|0.65|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.65|-3.25|0.1904
70876700|NCT00563381|141237441|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.99||||0.3172||95.0|-2.94|0.95|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.95|-2.94|0.3172
70876701|NCT00563381|141237442|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.67||||0.5017||95.0|-2.62|1.28|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||1.28|-2.62|0.5017
70876702|NCT00563381|141237443|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.23||||0.2174||95.0|-3.18|0.72|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.72|-3.18|0.2174
70876703|NCT00563381|141237444|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.1||||0.2682||95.0|-3.05|0.85|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.85|-3.05|0.2682
70876704|NCT00563381|141237445|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.59||||0.552||95.0|-2.55|1.36|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||1.36|-2.55|0.5520
70876705|NCT00667368|141237446|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-0.9||||0.754|TWO_SIDED|95.0|-12.0|10.1|||Two-sample test, Poisson||The risk difference reflects the treatment arm minus the control arm. The units are the number of positive tests for chlamydia and gonorrhea per 100 person-years.|||10.1|-12.0|0.754
70876706|NCT00667368|141237447|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
70876707|NCT03336853|141237448|SUPERIORITY||Mean Difference (Final Values)|0.74|||<|0.0001|TWO_SIDED|95.0|0.66|0.82|||t-test, 2 sided|||||0.82|0.66|<.0001
70876708|NCT01911689|141237449|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|||The independent T test was used to determine the differences for the T2\* value between the Control group and AP group.||||<0.01
70876709|NCT01911689|141237450|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||The independent T test was used to determine the differences for the T2\* value between the edematous AP and necrotizing AP||||0.05
70876710|NCT01911689|141237451|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||ANOVA|||Analysis of variance (ANOVA) was used to assess the differences in the T2\* value between the mild, moderate, and severe AP groups according to the MRSI score.||||<0.01
70876711|NCT01911689|141237451|SUPERIORITY_OR_OTHER|||||||0.0111|TWO_SIDED|95.0|||||t-test, 2 sided|||compare the T2\* value in the mild and moderate AP according to MRSI||||0.0111
70876712|NCT01911689|141237451|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|95.0|||||t-test, 2 sided|||compare the T2\* value between the mild and severe AP||||0.002
70876713|NCT01911689|141237451|SUPERIORITY_OR_OTHER|||||||0.071|TWO_SIDED|95.0|||||t-test, 2 sided|||compare the T2\* value between the moderate and severe AP according to MRSI||||0.071
70876714|NCT01911689|141237452|SUPERIORITY_OR_OTHER|||||||0.629|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.629
70957036|NCT01285609|141418062|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.917||||0.2421|TWO_SIDED|95.0|0.792|1.061||p-value based on stratified 2-sided log-rank test|Log Rank||Hazard of Ipilimumab over Placebo with 2-sided 95% confidence intervals based on a stratified Cox proportional hazards model with several stratification factors and treatment as the single covariate|Hazard ratio = Ipilimumab with Paclitaxel/Carboplatin over Placebo with Paclitaxel/Carboplatin||1.061|0.792|0.2421
70957037|NCT01285609|141418063|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.869||||0.0678|TWO_SIDED|95.0|0.749|1.009|||Log Rank|p-value based on an unstratified 2-sided log rank test|Hazard of Ipilimumab over Hazard of Placebo with 2-sided 95% confidence intervals are based on an unstratified Cox proportional hazards model with treatment as the single covariate|Hazard ratio = Ipilimumab with Paclitaxel/Carboplatin over Placebo with Paclitaxel/Carboplatin||1.009|0.749|0.0678
70957038|NCT03283072|141418064|SUPERIORITY|||||||0.592|||||||ANCOVA|Within, within repeated measures ANCOVA (gender as co-variate).||||||0.592
70957039|NCT03283072|141418065|SUPERIORITY|||||||0.721|||||||ANCOVA|Within, within repeated measures ANCOVA (gender as co-variate).||||||0.721
70957040|NCT03283072|141418066|SUPERIORITY|||||||0.553|||||||ANCOVA|Within, within repeated measures ANVOA (gender as covariate)||||||0.553
70957041|NCT02552368|141418083|SUPERIORITY|||||||0.002|||||||Paired t-Test|||||||0.002
70957042|NCT02552368|141418084|SUPERIORITY|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Signed-Rank Test for Performance COPM between Baseline and 12 weeks||||0.022
70957043|NCT02552368|141418084|SUPERIORITY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||Signed-Rank Test for Satisfaction COPM between Baseline and 12 weeks||||0.031
70957044|NCT05326815|141418140|OTHER|Spearman Correlation.|||||<|0.001|||||||t-test, 1 sided|||||||<0.001
70957045|NCT02545933|141418144|SUPERIORITY||least square mean difference|27.0||||0.011|TWO_SIDED|95.0|19.0|34.0|||ANOVA||DAPT group vs DAPT plus vorapaxar group|We hypothesized that adjunctive vorapaxar would result in a significant reduction of CAT-induced platelet aggregation. Assuming a 10% absolute reduction in CAT-induced maximal platelet aggregation with a common standard deviation of 13%, 37 patients per group with valid primary endpoint data were required to detect a significant difference with a 90% power and 2-sided alpha=0.05.||34|19|0.011
70957046|NCT00715962|141418155|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Fisher Exact|Fisher's exact test used as the rate of falling was low.||||||<.05
70957047|NCT00715962|141418156|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|||||||<.05
70957048|NCT03241225|141418195|SUPERIORITY||Mean Difference (Final Values)|3.59||||0.16|TWO_SIDED|95.0|-1.43|8.61|||t-test, 2 sided||Mean change in EM/PROTECT group not significantly different from mean change in EM/MH group, at week 12.|Week 12||8.61|-1.43|0.16
70957049|NCT03241225|141418196|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.79|TWO_SIDED|95.0|-1.37|1.05|||t-test, 2 sided|||Domain #1, Week 12||1.05|-1.37|0.79
70957050|NCT03241225|141418196|SUPERIORITY||Mean Difference (Final Values)|1.38||||0.19|TWO_SIDED|95.0|-0.7|3.46|||t-test, 2 sided|||Domain #2, Week 12||3.46|-0.70|0.19
70957051|NCT03241225|141418196|SUPERIORITY||Mean Difference (Final Values)|-4.53||||0.37|TWO_SIDED|95.0|-14.99|5.93|||t-test, 2 sided|||Domain #3, Week 12||5.93|-14.99|0.37
70957052|NCT03241225|141418196|SUPERIORITY||Mean Difference (Final Values)|-5.24||||0.026|TWO_SIDED|95.0|-9.75|-0.73|||t-test, 2 sided|||Domain #4, Week 12||-0.73|-9.75|0.026
70957053|NCT03241225|141418196|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.66|TWO_SIDED|95.0|-3.51|2.27|||t-test, 2 sided|||Domain #5, Week 12||2.27|-3.51|0.66
70957054|NCT03241225|141418197|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.14|TWO_SIDED|95.0|-0.26|1.66|||t-test, 2 sided|||Domain #1, Week 12||1.66|-0.26|0.14
70957055|NCT03241225|141418197|SUPERIORITY||Mean Difference (Final Values)|0.78||||0.047|TWO_SIDED|95.0|0.011|1.55||Domain #2|t-test, 2 sided|||Domain #2, Week 12||1.55|0.011|0.047
70957056|NCT03241225|141418197|SUPERIORITY||Mean Difference (Final Values)|0.65||||0.18|TWO_SIDED|95.0|-0.34|1.64|||t-test, 2 sided|||Domain #3, Week 12||1.64|-0.34|0.18
70957057|NCT00007345|141418212|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||An exact Cochran-Armitage trend test was used to compare the distributions. In view of the large number of tests performed, we only refer to those with P-values \<0.01 as statistically significant, with those for which 0.01 \<P\< 0.05 considered trends.|Cochran-Armitage trend test|||||||<0.01
70957058|NCT02074553|141418217|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|100.5|||||TWO_SIDED|90.0|93.14|108.44|||||The reported values are percentages of geometric least square mean ratio.|Analysis of variance (ANOVA) (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% confidence interval (CI).||108.44|93.14|
70957059|NCT02074553|141418217|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|97.82|||||TWO_SIDED|90.0|90.71|105.48|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||105.48|90.71|
70957060|NCT02074553|141418217|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|86.66|||||TWO_SIDED|90.0|80.32|93.5|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||93.5|80.32|
70957061|NCT02074553|141418217|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|88.62|||||TWO_SIDED|90.0|85.15|92.24|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||92.24|85.15|
70957062|NCT02074553|141418217|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|80.17|||||TWO_SIDED|90.0|77.08|83.39|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||83.39|77.08|
70957063|NCT02074553|141418217|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|79.95|||||TWO_SIDED|90.0|76.84|83.19|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||83.19|76.84|
70876715|NCT00732615|141237453|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|52.3|||<|0.001|TWO_SIDED|95.0|40.6|64.0||A fixed sequence test procedure was used to control the study level type I error. Order of test sequence started with the primary efficacy endpoint and proceeded to the 3 secondary efficacy endpoints, in the order defined in the protocol.|Fisher Exact|The 2-sided Fisher's Exact test was utilized to test for difference between NPSP558 and the placebo treatment groups.|The above two sided asymptotic 95% confidence interval is based on normal approximation.|The null hypothesis is that the % of subjects meeting primary efficacy endpoint criteria are the same for both tmt arms. The sample size was determined based on the assumption that 40% and 10% of subjects for NPSP558 and pbo arms would meet the endpt criteria, respectively. Based on 2-tailed test, alpha of 0.05 and 2-to-1 randomization ratio, 84 (56 NPSP558, 28 pbo) subjects who completing the study would achieve 80% statistical power. Adjusted for dropouts, planned enrollment was 110 subjects.||64.0|40.6|<0.001
70876716|NCT00732615|141237454|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Following fixed sequence test procedure described in the primary endpoint section, statistical hypothesis testing was conducted for this secondary endpoint after the testing for the primary endpoint reached statistical significance.|ANCOVA|ANCOVA analysis conducted using percentage change from baseline as dependent variable, treatment as factor, and baseline calcium dose as covariate.||The null hypothesis is that there is no difference between the percentage changes from baseline for the two treatment arms.||||<0.001
70876717|NCT00732615|141237455|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|11.711|||<|0.001|TWO_SIDED|95.0|2.619|52.363||Following fixed sequence test procedure described in the primary endpoint section, statistical hypothesis testing was conducted for this secondary endpoint after the testing for the first secondary endpoint reached statistical significance.|Cochran-Mantel-Haenszel|||The null hypothesis is that there is no difference between the proportions of subjects (who achieved this secondary endpoint) from the two treatment arms.||52.363|2.619|<0.001
70876718|NCT00732615|141237456|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.879||||0.747|TWO_SIDED|95.0|0.402|1.922||Following fixed sequence test procedure described in the primary endpoint section, statistical hypothesis testing was conducted for this secondary endpoint after the testing for the second secondary endpoint reached statistical significance.|Cochran-Mantel-Haenszel|||The null hypothesis is that the percentages of subjects with any reported clinical symptoms for the two treatment arms are the same.||1.922|0.402|0.747
70876719|NCT00923598|141237497|EQUIVALENCE|A method by Armitage et al was used, where by equivalence of treatments would be concluded if the 95% CI for the difference fell within the prespecified tolerated interval. Under these assumptions, a trial with 36 subjects (72 limbs) would correctly conclude there is no treatment difference with probability 80%, and incorrectly conclude equivalence when there is a difference of 20% with probability 5%.|Mean Difference (Final Values)|3.0||||0.05|TWO_SIDED|95.0|-10.0|17.0|||Fisher Exact|||||17|-10|0.05
70876720|NCT00828347|141237505|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED||||||Fisher Exact|||||||0.036
70876721|NCT01129960|141237506|SUPERIORITY_OR_OTHER|||||||0.3726|||||||Dunnett's test (analysis of covariance)|||||||0.3726
70876722|NCT01129960|141237506|SUPERIORITY_OR_OTHER|||||||0.8034|||||||Dunnett's test (analysis of covariance)|||||||0.8034
70876723|NCT01129960|141237506|SUPERIORITY_OR_OTHER|||||||0.1391|||||||Dunnett's test (analysis of covariance)|||||||0.1391
70876724|NCT02622321|141237515|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.13|||<|0.0001|TWO_SIDED|95.0|0.057|0.277||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Stratified Wald Test|||Analysis was performed using an NB regression model, which accounted for different follow-up times, with the participant's number of bleeds as a function of randomization and the time that each participant stays in the study included as an offset in the model. The model also included the number of bleeds (less than \[\<\] 9 or greater than or equal to \[\>/=\] 9) in the last 24 weeks prior to study entry as a stratification factor in the randomization.||0.277|0.057|<0.0001
70876725|NCT02622321|141237516|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.2|||<|0.0001|TWO_SIDED|95.0|0.102|0.375||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Stratified Wald Test|||Analysis was performed using an NB regression model, which accounted for different follow-up times, with the participant's number of bleeds as a function of randomization and the time that each participant stays in the study included as an offset in the model. The model also included the number of bleeds (\<9 or \>/=9) in the last 24 weeks prior to study entry as a stratification factor in the randomization.||0.375|0.102|<0.0001
70876726|NCT02622321|141237517|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.11|||<|0.0001|TWO_SIDED|95.0|0.055|0.218||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Non-Stratified Wald Test|||This intra-participant comparison of ABR for all bleeds was performed using an NB regression model.||0.218|0.055|<0.0001
70876727|NCT02622321|141237518|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.08|||<|0.0001|TWO_SIDED|95.0|0.031|0.198||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Non-Stratified Wald Test|||This intra-participant comparison of ABR for treated bleeds was performed using an NB regression model.||0.198|0.031|<0.0001
70876728|NCT02622321|141237519|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.11||||0.005|TWO_SIDED|95.0|0.025|0.52||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Stratified Wald Test|||Analysis was performed using an NB regression model, which accounted for different follow-up times, with the participant's number of bleeds as a function of randomization and the time that each participant stays in the study included as an offset in the model. The model also included the number of bleeds (\<9 or \>/=9) in the last 24 weeks prior to study entry as a stratification factor in the randomization.||0.520|0.025|0.0050
70876729|NCT02622321|141237520|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.23|||<|0.0001|TWO_SIDED|95.0|0.119|0.435||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Non-Stratified Wald Test|||This intra-participant comparison of ABR for all bleeds was performed using an NB regression model.||0.435|0.119|<0.0001
70876730|NCT02622321|141237521|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.21||||0.0003|TWO_SIDED|95.0|0.089|0.486||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Non-Stratified Wald Test|||This intra-participant comparison of ABR for treated bleeds was performed using an NB regression model.||0.486|0.089|0.0003
70957064|NCT02074553|141418218|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|99.12|||||TWO_SIDED|90.0|91.83|106.99|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||106.99|91.83|
70957065|NCT02074553|141418218|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|93.79|||||TWO_SIDED|90.0|86.94|101.17|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||101.17|86.94|
70957066|NCT02074553|141418218|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|80.32|||||TWO_SIDED|90.0|74.41|86.7|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||86.7|74.41|
70957067|NCT02074553|141418218|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|87.42|||||TWO_SIDED|90.0|83.92|91.07|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||91.07|83.92|
70957068|NCT02074553|141418218|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|78.87|||||TWO_SIDED|90.0|75.76|82.11|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||82.11|75.76|
70957069|NCT02074553|141418218|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|78.66|||||TWO_SIDED|90.0|75.53|81.92|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||81.92|75.53|
70957070|NCT02074553|141418219|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|90.34|||||TWO_SIDED|90.0|82.33|99.12|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||99.12|82.33|
70957071|NCT02074553|141418219|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|66.28|||||TWO_SIDED|90.0|60.45|72.68|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||72.68|60.45|
70876731|NCT02622321|141237522|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.08|||<|0.0001|TWO_SIDED|95.0|0.037|0.154||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Stratified Wald Test|||Analysis was performed using an NB regression model, which accounted for different follow-up times, with the participant's number of bleeds as a function of randomization and the time that each participant stays in the study included as an offset in the model. The model also included the number of bleeds (\<9 or \>/=9) in the last 24 weeks prior to study entry as a stratification factor in the randomization.||0.154|0.037|<0.0001
70876732|NCT02622321|141237523|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.05||||0.0002|TWO_SIDED|95.0|0.009|0.227||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Stratified Wald Test|||Analysis was performed using an NB regression model, which accounted for different follow-up times, with the participant's number of bleeds as a function of randomization and the time that each participant stays in the study included as an offset in the model. The model also included the number of bleeds (\<9 or \>/=9) in the last 24 weeks prior to study entry as a stratification factor in the randomization.||0.227|0.009|0.0002
70876733|NCT02622321|141237527|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|21.55||||0.0029|TWO_SIDED|95.0|7.89|35.22||Statistical significance was controlled at a two-sided alpha level of 0.05.|ANCOVA|||Actual number of participants included for inferential statistics in Arm A is 25. Means adjusted for covariates: baseline score, treatment group and treatment by baseline interaction arm. Analysis was performed using Analysis of Covariance (ANCOVA).||35.22|7.89|0.0029
70876734|NCT02622321|141237528|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|14.01||||0.0019|TWO_SIDED|95.0|5.56|22.45||Statistical significance was controlled at a two-sided alpha level of 0.05.|ANCOVA|||Actual number of participants included for inferential statistics in Arm A is 25. Means adjusted for covariates: baseline score, treatment group and treatment by baseline interaction arm.||22.45|5.56|0.0019
70876735|NCT02622321|141237529|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-9.72||||0.0171|TWO_SIDED|95.0|-17.62|-1.82||Statistical significance was controlled at a two-sided alpha level of 0.05.|ANCOVA|||Actual number of participants included for inferential statistics in Arm A is 29. Means adjusted for covariates: baseline score, treatment group and treatment by baseline interaction arm.||-1.82|-17.62|0.0171
70876736|NCT02622321|141237530|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.16||||0.0014|TWO_SIDED|95.0|-0.25|-0.07||Statistical significance was controlled at a two-sided alpha level of 0.05.|ANCOVA|||Actual number of participants included for inferential statistics in Arm A is 29. Means adjusted for covariates: baseline score, treatment group and treatment by baseline interaction arm.||-0.07|-0.25|0.0014
70876737|NCT00965718|141237551|SUPERIORITY_OR_OTHER_LEGACY|||||||0.123||||||Global health status scores at baseline and final observation point were compared via a 2-sided t-test.|t-test, 2 sided|||||||0.123
70876738|NCT02927080|141237643|SUPERIORITY|Percent Change in Total Muscle Volume (TMV) of the TA muscle in patients with FSHD administered ACE-083 when compared to placebo During Part 2 (randomized, controlled portion)|Mean Difference (Net)|9.54|STANDARD_ERROR_OF_MEAN|3.876||0.0138|TWO_SIDED|90.0|3.17|15.92|||ANCOVA|||D190 Percent change from baseline in TMV||15.92|3.17|0.0138
70876739|NCT02927080|141237643|SUPERIORITY|Percent Change in Total Muscle Volume (TMV) of the BB muscle in patients with FSHD administered ACE-083 when compared to placebo During Part 2 (randomized, controlled portion)|Mean Difference (Net)|16.39|STANDARD_ERROR_OF_MEAN|4.032|<|0.0001|TWO_SIDED|90.0|9.75|23.02|||ANCOVA|||D190 Percent change from baseline in TMV||23.02|9.75|<0.0001
70876740|NCT02927080|141237645|SUPERIORITY||Mean Difference (Final Values)|-2.73|STANDARD_ERROR_OF_MEAN|1.299||0.0359|TWO_SIDED|90.0|-4.86|-0.59|||ANCOVA|||D190 Absolute change from baseline in FF for the TA group administered ACE-083 when compared to Placebo in part 2||-0.59|-4.86|0.0359
70876741|NCT02927080|141237645|SUPERIORITY||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|1.359||0.3582|TWO_SIDED|90.0|-3.49|0.99|||ANCOVA|||D190 Absolute change from baseline in FF for the BB group administered ACE-083 when compared to Placebo in part 2||0.99|-3.49|0.3582
70876742|NCT02927080|141237646|SUPERIORITY||Mean Difference (Final Values)|-5.28|STANDARD_ERROR_OF_MEAN|4.068||0.1945|TWO_SIDED|90.0|-11.97|1.41|||ANCOVA|||D190 Percent change from baseline in 6 Minute Walk Test (MWT) distance from baseline||1.41|-11.97|0.1945
70876743|NCT02927080|141237646|SUPERIORITY||Mean Difference (Final Values)|4.69|STANDARD_ERROR_OF_MEAN|4.968||0.3451|TWO_SIDED|90.0|-3.48|12.86|||ANCOVA|||D190 Percent change from baseline in time to complete a 10 meter walk/run||12.86|-3.48|0.3451
70876744|NCT02927080|141237646|SUPERIORITY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|6.03||0.9402|TWO_SIDED|90.0|-9.47|10.37|||ANCOVA|||D190 Percent change from baseline in time to complete 4-stair climb (ascend)||10.37|-9.47|0.9402
70876745|NCT02927080|141237647|SUPERIORITY||Mean Difference (Final Values)|36.12|STANDARD_ERROR_OF_MEAN|14.18||0.0183|TWO_SIDED|90.0|11.78|60.46|||ANCOVA|||||60.46|11.78|0.0183
70876746|NCT02927080|141237648|SUPERIORITY||Mean Difference (Final Values)|2.89|STANDARD_ERROR_OF_MEAN|1.7||0.0895|TWO_SIDED|90.0|0.09|5.69|||ANCOVA|||||5.69|0.09|0.0895
70876747|NCT02927080|141237649|SUPERIORITY||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|3.459||0.5661|TWO_SIDED|90.0|-7.67|3.7|||ANCOVA|||Change from baseline in FSHD-HI, patient-reported outcome (PRO) measures Part 2 (Randomized, Controlled Portion)- Total Score for TA group part 2; compared to Placebo||3.70|-7.67|0.5661
70876748|NCT02927080|141237649|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|3.618||0.976|TWO_SIDED|90.0|-6.06|5.84|||ANCOVA|||Change from baseline in FSHD-HI, patient-reported outcome (PRO) measures Part 2 (Randomized, Controlled Portion)- Total Score for BB group part 2; compared to Placebo||5.84|-6.06|0.9760
70876749|NCT01199289|141237658|SUPERIORITY||LS Mean Difference|-0.068||||0.5838|TWO_SIDED|95.0|-0.311|0.175|||ANCOVA|||||0.175|-0.311|0.5838
70876750|NCT01199289|141237658|SUPERIORITY||LS Mean Difference|-0.075||||0.5391|TWO_SIDED|95.0|-0.316|0.166|||ANCOVA|||||0.166|-0.316|0.5391
70876751|NCT01199289|141237658|SUPERIORITY||LS Mean Difference|-0.113||||0.3583|TWO_SIDED|95.0|-0.355|0.129|||ANCOVA|||||0.129|-0.355|0.3583
70876752|NCT01199289|141237659|SUPERIORITY||LS Mean Difference|-0.047||||0.4076|TWO_SIDED|95.0|-0.157|0.064|||ANCOVA|||Pre-Bronchodilator||0.064|-0.157|0.4076
70876753|NCT01199289|141237659|SUPERIORITY||LS Mean Difference|-0.022||||0.6915|TWO_SIDED|95.0|-0.13|0.086|||ANCOVA|||Pre-Bronchodilator||0.086|-0.130|0.6915
70876754|NCT01199289|141237659|SUPERIORITY||LS Mean Difference|-0.019||||0.7271|TWO_SIDED|95.0|-0.126|0.088|||ANCOVA|||Pre-Bronchodilator||0.088|-0.126|0.7271
70876755|NCT01199289|141237659|SUPERIORITY||LS Mean Difference|0.005||||0.921|TWO_SIDED|95.0|-0.086|0.095|||ANCOVA|||Post-Bronchodilator||0.095|-0.086|0.9210
70876756|NCT01199289|141237659|SUPERIORITY||LS Mean Difference|0.07||||0.1139|TWO_SIDED|95.0|-0.017|0.157|||ANCOVA|||Post-Bronchodilator||0.157|-0.017|0.1139
70876757|NCT01199289|141237659|SUPERIORITY||LS Mean Difference|0.021||||0.6426|TWO_SIDED|95.0|-0.066|0.107|||ANCOVA|||Post-Bronchodilator||0.107|-0.066|0.6426
70957072|NCT02074553|141418219|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|41.04|||||TWO_SIDED|90.0|37.4|45.03|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||45.03|37.40|
70957073|NCT02074553|141418219|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|86.3|||||TWO_SIDED|90.0|81.77|91.09|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||91.09|81.77|
70957074|NCT02074553|141418219|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|77.0|||||TWO_SIDED|90.0|73.01|81.2|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||81.20|73.01|
70957075|NCT02074553|141418219|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|75.65|||||TWO_SIDED|90.0|71.71|79.82|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||79.82|71.71|
70957076|NCT02074553|141418221|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|91.67|||||TWO_SIDED|90.0|82.34|102.05|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||102.05|82.34|
70957077|NCT02074553|141418221|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|67.24|||||TWO_SIDED|90.0|60.44|74.79|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||74.79|60.44|
70957078|NCT02074553|141418221|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|34.32|||||TWO_SIDED|90.0|30.83|38.21|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||38.21|30.83|
70957079|NCT02074553|141418221|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|95.15|||||TWO_SIDED|90.0|89.1|101.62|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||101.62|89.10|
70957080|NCT02074553|141418221|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|73.26|||||TWO_SIDED|90.0|68.67|78.16|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||78.16|68.67|
70876758|NCT01199289|141237660|SUPERIORITY||LS Mean Difference|-16.847||||0.0262|TWO_SIDED|95.0|-31.686|-2.009|||ANCOVA|||AM||-2.009|-31.686|0.0262
70876759|NCT01199289|141237660|SUPERIORITY||LS Mean Difference|-6.723||||0.3627|TWO_SIDED|95.0|-21.239|7.793|||ANCOVA|||AM||7.793|-21.239|0.3627
70876760|NCT01199289|141237660|SUPERIORITY||LS Mean Difference|-5.488||||0.4507|TWO_SIDED|95.0|-19.791|8.814|||ANCOVA|||AM||8.814|-19.791|0.4507
70876761|NCT01199289|141237660|SUPERIORITY||LS Mean Difference|-10.426||||0.1228|TWO_SIDED|95.0|-23.686|2.834|||ANCOVA|||PM||2.834|-23.686|0.1228
70876762|NCT01199289|141237660|SUPERIORITY||LS Mean Difference|-6.738||||0.3092|TWO_SIDED|95.0|-19.758|6.281|||ANCOVA|||PM||6.281|-19.758|0.3092
70957081|NCT02074553|141418221|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|67.76|||||TWO_SIDED|90.0|63.48|72.33|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||72.33|63.48|
70957082|NCT02074553|141418223|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|95.77|||||TWO_SIDED|90.0|87.54|104.79|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||104.79|87.54|
70957083|NCT02074553|141418223|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|78.69|||||TWO_SIDED|90.0|71.97|86.04|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||86.04|71.97|
70957084|NCT02074553|141418223|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|53.91|||||TWO_SIDED|90.0|49.27|58.98|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||58.98|49.27|
70957085|NCT02074553|141418223|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|90.16|||||TWO_SIDED|90.0|86.14|94.37|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||94.37|86.14|
70957086|NCT02074553|141418223|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|73.76|||||TWO_SIDED|90.0|70.52|77.15|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||77.15|70.52|
70957087|NCT02074553|141418223|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|70.94|||||TWO_SIDED|90.0|67.8|74.22|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||74.22|67.80|
70957088|NCT02074553|141418224|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|93.05|||||TWO_SIDED|90.0|84.24|102.78|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||102.78|84.24|
70957089|NCT02074553|141418224|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|74.35|||||TWO_SIDED|90.0|67.37|82.06|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||82.06|67.37|
70876763|NCT01199289|141237660|SUPERIORITY||LS Mean Difference|-8.043||||0.2167|TWO_SIDED|95.0|-20.831|4.744|||ANCOVA|||PM||4.744|-20.831|0.2167
70876764|NCT01199289|141237661|SUPERIORITY||LS Mean Difference|0.331||||0.5157|TWO_SIDED|95.0|-0.67|1.332|||ANCOVA|||||1.332|-0.670|0.5157
70876765|NCT01199289|141237661|SUPERIORITY||LS Mean Difference|-0.234||||0.6434|TWO_SIDED|95.0|-1.229|0.76|||ANCOVA|||||0.760|-1.229|0.6434
70876766|NCT01199289|141237661|SUPERIORITY||LS Mean Difference|-0.199||||0.6954|TWO_SIDED|95.0|-1.196|0.799|||ANCOVA|||||0.799|-1.196|0.6954
70876767|NCT01199289|141237662|SUPERIORITY||LS Mean Difference|-0.283||||0.5577|TWO_SIDED|95.0|-1.231|0.665|||ANCOVA|||||0.665|-1.231|0.5577
70876768|NCT01199289|141237662|SUPERIORITY||LS Mean Difference|0.038||||0.9366|TWO_SIDED|95.0|-0.904|0.98|||ANCOVA|||||0.980|-0.904|0.9366
70876769|NCT01199289|141237662|SUPERIORITY||LS Mean Difference|0.138||||0.7745|TWO_SIDED|95.0|-0.808|1.084|||ANCOVA|||||1.084|-0.808|0.7745
70876770|NCT01199289|141237663|SUPERIORITY||LS Mean Difference|0.026||||0.8524|TWO_SIDED|95.0|-0.251|0.303|||ANCOVA|||||0.303|-0.251|0.8524
70876771|NCT01199289|141237663|SUPERIORITY||LS Mean Difference|-0.033||||0.8139|TWO_SIDED|95.0|-0.305|0.24|||ANCOVA|||||0.240|-0.305|0.8139
70876772|NCT01199289|141237663|SUPERIORITY||LS Mean Difference|-0.002||||0.9881|TWO_SIDED|95.0|-0.281|0.276|||ANCOVA|||||0.276|-0.281|0.9881
70876773|NCT01199289|141237664|SUPERIORITY|With use of SABA|LS Mean Difference|-0.062||||0.1213|TWO_SIDED|95.0|-0.141|0.017|||ANCOVA|||||0.017|-0.141|0.1213
70876774|NCT01199289|141237664|SUPERIORITY|With use of SABA|LS Mean Difference|-0.017||||0.6643|TWO_SIDED|95.0|-0.095|0.061|||ANCOVA|||||0.061|-0.095|0.6643
70876775|NCT01199289|141237664|SUPERIORITY||LS Mean Difference|-0.042||||0.2879|TWO_SIDED|95.0|-0.121|0.036|||ANCOVA|With use of SABA||||0.036|-0.121|0.2879
70876776|NCT01199289|141237664|SUPERIORITY|Without use of SABA|LS Mean Difference|-0.074||||0.0546|TWO_SIDED|95.0|-0.15|0.001|||ANCOVA|||||0.001|-0.150|0.0546
70876777|NCT01199289|141237664|SUPERIORITY||LS Mean Difference|-0.004||||0.9078|TWO_SIDED|95.0|-0.08|0.071|||ANCOVA|||Without use of SABA||0.071|-0.080|0.9078
70876778|NCT01199289|141237664|SUPERIORITY||LS Mean Difference|-0.035||||0.3616|TWO_SIDED|95.0|-0.111|0.04|||ANCOVA|||Without use of SABA||0.040|-0.111|0.3616
70876779|NCT00127712|141237673|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Chi-squared|||||||0.02
70876780|NCT00127712|141237674|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
70876781|NCT00127712|141237675|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||||||0.001
70876782|NCT00127712|141237676|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.79
70876783|NCT02642614|141237678|SUPERIORITY_OR_OTHER||Ratio of adjusted mean|1.59|STANDARD_ERROR_OF_MEAN|0.51||0.154|TWO_SIDED|90.0|0.93|2.72|||ANCOVA||"Standard Error of Mean is actually Standard Error of ratio of adjusted means, adjusted means ratio is calculated as 5 milligram BI 1026706 divided by Placebo."|Adjusted means were calculated by exponentiating Least Square (LS) means of corresponding values obtained from fitting an ANCOVA model to the natural log transformed endpoint variable, including treatment effect and study baseline as covariates, and adjusting for stratification factors (extensive pharmacokinetic (PK) sub-study participation and Multiple-breath washout (MBW) sub-study participation)||2.72|0.93|0.1540
70876784|NCT02642614|141237678|SUPERIORITY_OR_OTHER||Ratio of adjusted mean|1.58|STANDARD_ERROR_OF_MEAN|0.49||0.143|TWO_SIDED|90.0|0.94|2.65|||ANCOVA||"Standard Error of Mean is actually Standard Error of ratio of adjusted means, adjusted means ratio is calculated as 25 milligram BI 1026706 divided by Placebo."|The adjusted means were calculated by exponentiating the LS means of the corresponding values obtained from fitting an ANCOVA model to the natural log transformed endpoint variable, including treatment effect and study baseline as covariates, and adjusting for stratification factors (extensive PK sub-study participation and MBW sub-study participation)||2.65|0.94|0.1430
70876785|NCT02642614|141237678|SUPERIORITY_OR_OTHER||Ratio of adjusted mean|1.44|STANDARD_ERROR_OF_MEAN|0.45||0.2398|TWO_SIDED|90.0|0.86|2.41|||ANCOVA||"Standard Error of Mean is actually Standard Error of ratio of adjusted means, adjusted means ratio is calculated as 100 milligram BI 1026706 divided by Placebo."|The adjusted means were calculated by exponentiating the LS means of the corresponding values obtained from fitting an ANCOVA model to the natural log transformed endpoint variable, including treatment effect and study baseline as covariates, and adjusting for stratification factors (extensive PK sub-study participation and MBW sub-study participation)||2.41|0.86|0.2398
70876786|NCT03316131|141237722|OTHER||Mean Difference (Net)|0.28|||||TWO_SIDED|95.0|-8.67|9.22||||||||9.22|-8.67|
70876787|NCT03316131|141237723|OTHER||Geometric mean ratio|1.14|||||TWO_SIDED|90.0|1.03|1.25||||||Treatment A/Treatment B, for Verinurad||1.25|1.03|
70876788|NCT03316131|141237723|OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.88|1.07||||||Treatment A/Treatment B, for M1||1.07|0.88|
70876789|NCT03316131|141237723|OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.91|1.08||||||Treatment A/Treatment B, for M8||1.08|0.91|
70876790|NCT03316131|141237724|OTHER||Geometric mean ratio|1.06|||||TWO_SIDED|90.0|1.0|1.13||||||Treatment A/Treatment B, for Verinurad||1.13|1.00|
70876791|NCT03316131|141237724|OTHER||Geometric mean ratio|0.96|||||TWO_SIDED|90.0|0.9|1.02||||||Treatment A/Treatment B, for M1||1.02|0.90|
70876792|NCT03316131|141237724|OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.94|1.04||||||Treatment A/Treatment B, for M8||1.04|0.94|
70876793|NCT03316131|141237728|OTHER||Geometric mean ratio|1.06|||||TWO_SIDED|90.0|1.0|1.13||||||Treatment A/Treatment B, for Verinurad||1.13|1.00|
70876794|NCT03316131|141237728|OTHER||Geometric mean ratio|0.96||||||90.0|0.9|1.02||||||Treatment A/Treatment B, for M1||1.02|0.90|
70876795|NCT03316131|141237728|OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.94|1.04||||||Treatment A/Treatment B, for M8||1.04|0.94|
70876796|NCT04615923|141237738|SUPERIORITY||Disease Rate Ratio|0.99|STANDARD_DEVIATION|0.103|||TWO_SIDED|95.0|0.801|1.207||Posterior probability that the disease rate ratio (DRR) is less than 1 (i.e. Pridopidine slowed progression) was (0.5475). NOTE: p-value is not provided for Bayesian model.|Bayesian shared-parameter model|A Bayesian shared-parameter model of change in disease severity as measured by ALSFRS-R total score and mortality.|"DDR \<1 imply slowing of disease progression by verdiperstat relative to placebo.Note: reported Confidence Interval is actually a Bayesian credible interval."||The DRR parameter for active treatment represents the relative change to the rate of decline of ALSFRS-R and the rate of mortality of treated participant relative to a placebo participant. The estimated DRR can also be interpreted as the average rate of decline in function and mortality. The model includes covariates for baseline use of edaravone, baseline use of riluzole, months since onset of symptoms, and pre-baseline slope of ALSFRS-R, and random effects for regimen and participant-specific slopes.|1.207|0.801|
70876797|NCT04615923|141237740|SUPERIORITY||Median Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.334||0.78|TWO_SIDED|95.0|-0.75|0.57|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Pridopidine 24-week change from baseline relative to placebo 24-week change from baseline.|||0.57|-0.75|0.78
70876798|NCT04615923|141237741|SUPERIORITY||Median Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.217||0.6594|TWO_SIDED|95.0|-0.33|0.52|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Pridopidine 24-week change from baseline relative to placebo 24-week change from baseline.|||0.52|-0.33|0.6594
70957090|NCT02074553|141418224|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|43.94|||||TWO_SIDED|90.0|39.78|48.53|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||48.53|39.78|
70957091|NCT02074553|141418224|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|90.21|||||TWO_SIDED|90.0|86.12|94.49|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||94.49|86.12|
70957092|NCT02074553|141418224|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|72.72|||||TWO_SIDED|90.0|69.48|76.12|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||76.12|69.48|
70957093|NCT02074553|141418224|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|69.34|||||TWO_SIDED|90.0|66.23|72.61|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||72.61|66.23|
70957094|NCT02074553|141418227|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|98.79|||||TWO_SIDED|90.0|91.25|106.95|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||106.95|91.25|
70957095|NCT02074553|141418227|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|91.58|||||TWO_SIDED|90.0|84.65|99.08|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||99.08|84.65|
70957096|NCT02074553|141418227|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|73.41|||||TWO_SIDED|90.0|67.81|79.47|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||79.47|67.81|
70957097|NCT02074553|141418227|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|88.81|||||TWO_SIDED|90.0|85.62|92.13|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||92.13|85.62|
70957098|NCT02074553|141418227|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|77.74|||||TWO_SIDED|90.0|74.99|80.6|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||80.60|74.99|
70957099|NCT02074553|141418227|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|76.65|||||TWO_SIDED|90.0|73.92|79.49|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||79.49|73.92|
70876799|NCT04615923|141237742|SUPERIORITY||Mean Difference (Net)|-0.46|STANDARD_ERROR_OF_MEAN|1.745||0.7918|TWO_SIDED|95.0|-3.89|2.96|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Pridopidine 24-week change from baseline relative to placebo 24-week change from baseline.|||2.96|-3.89|0.7918
70876800|NCT04615923|141237743|SUPERIORITY||Median Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.426||0.9903|TWO_SIDED|95.0|-0.83|0.84|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Pridopidine 24-week change from baseline relative to placebo 24-week change from baseline.|||0.84|-0.83|0.9903
70876801|NCT04615923|141237744|SUPERIORITY|Analysis performed using interval-censored survival analysis. This type of model accommodates interval censoring between ALSFRS-R assessments|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.69|1.27|||Regression, Cox|Interval censored cox model adjusted for time since symptom onset, pre-baseline change in ALSFRS-R, baseline use of edaravone, riluzole, and neudexta||||1.27|0.69|
70876802|NCT04615923|141237745|SUPERIORITY||Mean Difference (Net)|-1.78|STANDARD_ERROR_OF_MEAN|3.285||0.5888|TWO_SIDED|95.0|-8.23|4.67|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Pridopidine 24-week change from baseline relative to placebo 24-week change from baseline.|||4.67|-8.23|0.5888
70876803|NCT04615923|141237746|SUPERIORITY|||||||0.969|||||||Log Rank|||||||0.9690
70876804|NCT02282020|141237747|SUPERIORITY||Odds Ratio (OR)|2.53||||0.002|TWO_SIDED|95.0|1.4|4.58|||Regression, Logistic|Model includes a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months)|An odds ratio \>1 favours the olaparib arm|||4.58|1.40|0.002
70876805|NCT02282020|141237748|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.013|TWO_SIDED|95.0|0.43|0.91||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||0.91|0.43|0.013
70876806|NCT02282020|141237749|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.229|TWO_SIDED|95.0|0.56|1.15||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||1.15|0.56|0.229
70876807|NCT02282020|141237750|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.714|TWO_SIDED|95.0|0.76|1.49||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||1.49|0.76|0.714
70876808|NCT02282020|141237751|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.005|TWO_SIDED|95.0|0.41|0.85||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \<1 favours the olaparib arm|||0.85|0.41|0.005
70876809|NCT02282020|141237752|SUPERIORITY||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.35|0.69||Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||0.69|0.35|<0.001
70876810|NCT02282020|141237753|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.089|TWO_SIDED|95.0|0.53|1.05||Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||1.05|0.53|0.089
70876811|NCT02282020|141237754|SUPERIORITY||Hazard Ratio (HR)|0.2|||<|0.001|TWO_SIDED|95.0|0.14|0.29||Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||0.29|0.14|<0.001
70876812|NCT02282020|141237757|SUPERIORITY||Mean Difference (Final Values)|2.5||||0.108|TWO_SIDED|95.0|-0.5|5.5|||Mixed Models Analysis|Model includes factors for patient, treatment, visit, treatment by visit interaction, baseline TOI score and baseline TOI score by visit interaction.||||5.5|-0.5|0.108
70876813|NCT02282020|141237758|SUPERIORITY||Odds Ratio (OR)|2.24||||0.092|TWO_SIDED|95.0|0.88|6.86||Estimated from an unadjusted logistic regression model|Regression, Logistic||An odds ratio \> 1 favours the olaparib arm|||6.86|0.88|0.092
70876814|NCT02282020|141237759|SUPERIORITY||Odds Ratio (OR)|2.4||||0.004|TWO_SIDED|95.0|1.32|4.39||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Regression, Logistic||An odds ratio \> 1 favours the olaparib arm|||4.39|1.32|0.004
70876815|NCT02282020|141237760|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.014|TWO_SIDED|95.0|0.42|0.91||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||0.91|0.42|0.014
70876816|NCT02282020|141237761|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.213|TWO_SIDED|95.0|0.56|1.14||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||1.14|0.56|0.213
70876817|NCT02282020|141237762|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.699|TWO_SIDED|95.0|0.76|1.51||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||1.51|0.76|0.699
70876818|NCT02282020|141237763|SUPERIORITY||Hazard Ratio (HR)|0.18|||<|0.001|TWO_SIDED|95.0|0.12|0.27||Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||0.27|0.12|<0.001
70876819|NCT02282020|141237764|SUPERIORITY||Hazard Ratio (HR)|0.46|||<|0.001|TWO_SIDED|95.0|0.33|0.66||Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||0.66|0.33|<0.001
70876820|NCT02282020|141237765|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.055|TWO_SIDED|95.0|0.51|1.01||Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||1.01|0.51|0.055
70876821|NCT03227029|141237793|OTHER||% vaccine recipients with solicited AEs|64.0|||||TWO_SIDED|90.0|46.0|80.0|||||Proportions of study participants were calculated and presented with 90% exact confidence intervals. This highlights that we are 95% sure that the true proportion is not higher that the upper limit of the confidence interval.|||80|46|
70876822|NCT03227029|141237793|OTHER||% vaccine recipients with solicited AEs|84.0|||||TWO_SIDED|90.0|67.0|94.0||||||||94|67|
70876823|NCT03227029|141237793|OTHER||% placebo recipients with solicited AEs|58.0|||||TWO_SIDED|90.0|32.0|82.0||||||||82|32|
70876824|NCT03227029|141237794|OTHER||% vaccine recipients with usolicited AEs|36.0|||||TWO_SIDED|90.0|20.0|54.0||||||||54|20|
70876825|NCT03227029|141237794|OTHER||% vaccine recipients with usolicited AEs|52.0|||||TWO_SIDED|90.0|34.0|69.0||||||||69|34|
70876826|NCT03227029|141237794|OTHER||% placebo recipients with usolicited AEs|42.0|||||TWO_SIDED|90.0|18.0|68.0||||||||68|18|
70876827|NCT03227029|141237796|OTHER||% recipients infected with vaccine virus|88.0|||||TWO_SIDED|90.0|72.0|97.0||||||||97|72|
70876828|NCT03227029|141237796|OTHER||% recipients infected with vaccine virus|96.0|||||TWO_SIDED|90.0|82.0|100.0||||||||100|82|
70876829|NCT03227029|141237796|OTHER||% recipients infected with vaccine virus|0.0|||||TWO_SIDED|90.0|0.0|22.0||||||||22|0|
70876830|NCT03227029|141237799|OTHER||% with >=4 fold rise in RSV-PRNT|60.0|||||TWO_SIDED|90.0|42.0|76.0||||||||76|42|
70876831|NCT03227029|141237799|OTHER||% with >=4 fold rise in RSV-PRNT|92.0|||||TWO_SIDED|90.0|76.0|98.0||||||||98|76|
70876832|NCT03227029|141237799|OTHER||% with >=4 fold rise in RSV-PRNT|0.0|||||TWO_SIDED|90.0|0.0|22.0||||||||22|0|
70876833|NCT03227029|141237799|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Fisher Exact|||||||<0.01
70876834|NCT03227029|141237799|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Fisher Exact|||||||<0.01
70876835|NCT03227029|141237800|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Wilcoxon test was used to test the hypothesis that antibody levels at Day 56 were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.01
70876836|NCT03227029|141237800|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Wilcoxon test was used to test the hypothesis that antibody levels at Day 56 were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.01
70876837|NCT03227029|141237801|OTHER||% with >=4 fold rise in RSV F protein|60.0|||||TWO_SIDED|90.0|42.0|76.0||||||||76|42|
70876838|NCT03227029|141237801|OTHER||% with >=4 fold rise in RSV F protein|92.0|||||TWO_SIDED|90.0|76.0|98.0||||||||98|76|
70876839|NCT03227029|141237801|OTHER||% with >=4 fold rise in RSV F protein|0.0|||||TWO_SIDED|90.0|0.0|22.0||||||||22|0|
70876840|NCT03227029|141237801|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Fisher Exact|||||||<0.01
70876841|NCT03227029|141237801|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Fisher Exact|||||||<0.01
70876842|NCT03227029|141237802|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Wilcoxon test was used to test the hypothesis that antibody levels at Day 56 were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.01
70876843|NCT03227029|141237802|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Wilcoxon test was used to test the hypothesis that antibody levels at Day 56 were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.01
70876844|NCT00770289|141237815|SUPERIORITY_OR_OTHER||Pearson's correlation coefficient|0.899|||<|0.0001|TWO_SIDED|95.0|0.886|0.911||The statistical testing was done at alpha = 0.05.|Pearson's correlation|||Change from baseline at Week 12: Pearson's correlation coefficient was used to evaluate compatibility between the questionnaires.||0.911|0.886|<0.0001
70876845|NCT00770289|141237815|SUPERIORITY_OR_OTHER||Pearson's correlation coefficient|0.797|||<|0.0001|TWO_SIDED|95.0|0.771|0.82||The statistical testing was done at alpha = 0.05.|Pearson's correlation|||Change from baseline at Week 12: Pearson's correlation coefficient was used to evaluate compatibility between the questionnaires.||0.820|0.771|<0.0001
70876846|NCT00770289|141237815|SUPERIORITY_OR_OTHER||Pearson's correlation coefficient|0.765|||<|0.0001|TWO_SIDED|95.0|0.736|0.791||The statistical testing was done at alpha = 0.05.|Pearson's correlation|||Change from baseline at Week 12: Pearson's correlation coefficient was used to evaluate compatibility between the questionnaires.||0.791|0.736|<0.0001
70876847|NCT00748033|141237879|OTHER|||||||0.065|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test, two-sided. Testing the hypothesis that the perception is same.||||0.0650
70876848|NCT00748033|141237880|OTHER|||||||0.2487|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test, two-sided. Testing the hypothesis that the perception is same.||||0.2487
70957100|NCT02074553|141418228|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|89.41|||||TWO_SIDED|90.0|81.7|97.84|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||97.84|81.7|
70957101|NCT02074553|141418228|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|66.84|||||TWO_SIDED|90.0|61.12|73.1|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||73.1|61.12|
70957102|NCT02074553|141418228|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|42.32|||||TWO_SIDED|90.0|38.68|46.32|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||46.32|38.68|
70957103|NCT02074553|141418228|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|88.76|||||TWO_SIDED|90.0|84.21|93.56|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||93.56|84.21|
70957104|NCT02074553|141418228|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|75.82|||||TWO_SIDED|90.0|71.99|79.86|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||79.86|71.99|
70957105|NCT02074553|141418228|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|73.26|||||TWO_SIDED|90.0|69.53|77.19|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||77.19|69.53|
70957106|NCT02074553|141418229|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|97.23|||||TWO_SIDED|90.0|89.85|105.21|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||105.21|89.85|
70957107|NCT02074553|141418229|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|87.16|||||TWO_SIDED|90.0|80.59|94.26|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||94.26|80.59|
70957108|NCT02074553|141418229|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|67.86|||||TWO_SIDED|90.0|62.71|73.43|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||73.43|62.71|
70957109|NCT02074553|141418229|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|88.28|||||TWO_SIDED|90.0|85.06|91.63|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||91.63|85.06|
70876849|NCT00748033|141237881|OTHER|||||||0.7288|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test, two-sided. Testing the hypothesis that the perception is same.||||0.7288
70957110|NCT02074553|141418229|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|76.79|||||TWO_SIDED|90.0|74.03|79.65|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||79.65|74.03|
70957111|NCT02074553|141418229|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|75.43|||||TWO_SIDED|90.0|72.7|78.27|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||78.27|72.70|
70957112|NCT02342743|141418270|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70957113|NCT02342743|141418271|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70957114|NCT02342743|141418272|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70957115|NCT02342743|141418273|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70957116|NCT02342743|141418274|SUPERIORITY|||||||0.012||||||Threshold for statistical significance set to 0.05|Wilcoxon (Mann-Whitney)|||||||0.012
70957117|NCT02342743|141418275|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70957118|NCT02342743|141418277|SUPERIORITY|||||||0.03||||||Threshold for statistical significance set to 0.05|Wilcoxon (Mann-Whitney)|||||||0.030
70957119|NCT04187989|141418286|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.006|STANDARD_ERROR_OF_MEAN|0.239||0.98|TWO_SIDED|95.0|-0.478|0.466|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.466|-.478|.980
70957120|NCT04187989|141418287|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|0.265|STANDARD_ERROR_OF_MEAN|0.18||0.14|TWO_SIDED|95.0|-0.092|0.621||The p-value is for the coefficient of the treatment/control indicator in the above mixed model|t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.621|-.092|.140
70957121|NCT04187989|141418289|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|0.064|STANDARD_ERROR_OF_MEAN|0.181||0.724|TWO_SIDED|95.0|-0.294|0.421||Two-sided test of the null hypothesis of no difference between groups|t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.421|-.294|.724
70876850|NCT00748033|141237882|OTHER|||||||0.0045|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test, two-sided. Testing the hypothesis that the perception is same.||||0.0045
70876851|NCT00748033|141237883|OTHER|||||||0.4561|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test if the difference between 5s and 24h is equal to 0.||Testing the hypothesis that 5s and 24 h are equal at insertion.||||0.4561
70876852|NCT00748033|141237884|OTHER|||||||0.1797|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test if the difference between 5s and 24h is equal to 0.||Testing the hypothesis that 5s and 24 h are equal at withdrawal.||||0.1797
70876853|NCT00748033|141237885|OTHER|||||||0.5171|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test if the difference between 5s and 24h is equal to 0.||The mean perception of the 5s and the 24h catheter is calculated for each patient. The patients are then divided in two groups depending on the order the patients received the two catheters and the hypotheses that the mean of the 5s and the 24h catheter is equal in the two groups are tested. If the test results in a significant p-value it can be concluded that a carry-over effect is present.||||0.5171
70876854|NCT00748033|141237886|OTHER|||||||0.7105|||||||Wilcoxon (Mann-Whitney)|||The mean perception of the 5s and the 24h catheter is calculated for each patient. The patients are then divided in two groups depending on the order the patients received the two catheters and the hypotheses that the mean of the 5s and the 24h catheter is equal in the two groups are tested. If the test results in a significant p-value it can be concluded that a carry-over effect is present.||||0.7105
70876855|NCT00748033|141237887|OTHER|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||||||0.0003
70876856|NCT00748033|141237888|OTHER|||||||0.0346|||||||Wilcoxon (Mann-Whitney)|||||||0.0346
70876857|NCT00748033|141237889|OTHER|||||||0.0016|||||||Wilcoxon (Mann-Whitney)|||||||0.0016
70876858|NCT03557151|141237916|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.33||0.895|TWO_SIDED|95.0|-0.68|0.6|||Mixed Models Analysis|||Transdisciplinary Care is being compared to Usual Care using the Time 2 HbA1c (as baseline) and Time 5 HbA1c (as the outcome) controlling for race/ethnicity, gender, and age of the patient. The interaction of condition and time is used to evaluate the treatment effect. Missing data were not imputed.||0.60|-0.68|0.895
70876859|NCT03557151|141237917|SUPERIORITY||Slope|2.29|STANDARD_ERROR_OF_MEAN|2.34||0.33|TWO_SIDED|95.0|-2.29|6.88|||Mixed Models Analysis|||TC is being compared to UC using baseline and 12 month data, controlling for patient age, sex, and race/ethnicity. The interaction between condition and time is used to examine the treatment effect. Missing data were not imputed.||6.88|-2.29|.33
70876860|NCT03557151|141237918|SUPERIORITY||Slope|4.1|STANDARD_ERROR_OF_MEAN|2.25||0.07|TWO_SIDED|95.0|-0.32|8.53|||Mixed Models Analysis|||TC is being compared to UC using baseline and 12 month data and controlling for patient age, sex, and race/ethnicity. The interaction between condition and time is used to evaluate the treatment effect. Missing data are not imputed.||8.53|-.32|.07
70876861|NCT03557151|141237919|SUPERIORITY||Slope|-2.38|STANDARD_ERROR_OF_MEAN|3.77||0.527|TWO_SIDED|95.0|-9.77|5.0|||Mixed Models Analysis|||This analysis included baseline and 12-month data. The interaction of condition (TC or UC) and time was used to examine the treatment effect. Child sex, age, and race/ethnicity were covariates. Missing data were not imputed.||5.0|-9.77|.527
70876862|NCT03557151|141237920|SUPERIORITY||Slope|-3.3|STANDARD_ERROR_OF_MEAN|2.89||0.253|TWO_SIDED|95.0|-8.94|2.35|||Mixed Models Analysis|||This analysis uses baseline and 12 month data. The interaction of condition and time is used to evaluate the treatment effect. Child sex, age, and race/ethnicity were used as covariates. Missing data were not imputed.||2.35|-8.94|.253
70876863|NCT03557151|141237921|SUPERIORITY||Slope|9.69|STANDARD_ERROR_OF_MEAN|3.77||0.01|TWO_SIDED|95.0|2.31|17.08|||Mixed Models Analysis|||This analysis included baseline and 12 month data. The condition by time interaction was used to evaluate the treatment effect. Child age, sex, and race/ethnicity were included as covariates. Missing data were not imputed.||17.08|2.31|0.01
70876864|NCT03557151|141237922|SUPERIORITY||Slope|0.45|STANDARD_ERROR_OF_MEAN|2.07||0.83|TWO_SIDED|95.0|-3.62|4.35|||Mixed Models Analysis|||This analysis uses baseline and 12-month data. The interaction between condition and time is used to evaluate the treatment effect. Child age, sex, and race/ethnicity were covariates. Missing data were not imputed.||4.35|-3.62|.83
70876865|NCT01414075|141237923|OTHER|||||||0.0757||||||Threshold for significance at 0.05 level.|ANCOVA|||Analysis of covariance (ANCOVA) model with treatment as a factor, baseline Hb and iron repletion status as covariates was used to compare treatments.||||0.0757
70876866|NCT01414075|141237923|OTHER|||||||0.063||||||Threshold for significance at 0.05 level.|ANCOVA|||ANCOVA model with treatment as a factor, baseline Hb and iron repletion status as covariates was used to compare treatments.||||0.0630
70876867|NCT01414075|141237923|OTHER|||||||0.8653||||||Threshold for significance at 0.05 level.|ANCOVA|||ANCOVA model with treatment as a factor, baseline Hb and iron repletion status as covariates was used to compare treatments.||||0.8653
70876868|NCT01414075|141237923|OTHER|||||||0.8982||||||Threshold for significance at 0.05 level.|ANCOVA|||ANCOVA model with treatment as a factor, baseline Hb and iron repletion status as covariates was used to compare treatments.||||0.8982
70876869|NCT00467259|141237984|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|p-value obtained from Fisher's exact test and corresponds to the test of the null hypothesis of no treatment difference.||1000 naturally postmenopausal women not on concomitant E+P therapy at baseline were to be randomized (800 TTS; 200 placebo). It was assumed 60% would complete 1 year and 80% of these would have evaluable biopsies. Of the 800 randomized to TTS approximately 380 were expected to have evaluable biopsies at 1 year. 380 patients on TTS with evaluable biopsies at 1 year would provide 90% power to rule out an incidence of hyperplasia of 2% using the upper bound of a 2-sided 95% CI.||||1.0000
70876870|NCT00467259|141237985|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|p-value obtained from Fisher's exact test and corresponds to the test of the null hypothesis of no treatment difference.||1000 naturally postmenopausal women not on concomitant E+P therapy at baseline were to be randomized (800 TTS; 200 placebo). It was assumed 60% would complete 1 year and 80% of these would have evaluable biopsies. Of the 800 randomized to TTS approximately 380 were expected to have evaluable biopsies at 1 year. 380 patients on TTS with evaluable biopsies at 1 year would provide 90% power to rule out an incidence of hyperplasia of 2% using the upper bound of a 2-sided 95% CI.||||1.0000
70876871|NCT00467259|141237986|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|p-value obtained from Fisher's Exact test and corresponds to the test of the null hypothesis of no treatment difference.||1000 naturally postmenopausal women not on concomitant E+P therapy at baseline were to be randomized (800 TTS; 200 placebo). It was assumed 60% would complete 1 year and 80% of these would have evaluable biopsies. Of the 800 randomized to TTS approximately 380 were expected to have evaluable biopsies at 1 year. 380 patients on TTS with evaluable biopsies at 1 year would provide 90% power to rule out an incidence of hyperplasia of 2% using the upper bound of a 2-sided 95% CI.||||1.0000
70876872|NCT01958008|141237997|SUPERIORITY_OR_OTHER||Slope|1.2674|STANDARD_ERROR_OF_MEAN|0.1019|||TWO_SIDED|95.0|1.0636|1.4713|||Regression, Linear|Power model that describes the functional relationship between the dose and pharmacokinetic endpoint Cmax,ss||Dose proportionality was analysed over the dose range 10 to 50 mg for plasma PK parameters based on a power model||1.4713|1.0636|
70876873|NCT01958008|141237998|SUPERIORITY_OR_OTHER||Slope|1.2139|STANDARD_ERROR_OF_MEAN|0.081|||TWO_SIDED|95.0|1.0519|1.3759|||Regression, Linear|Power model that describes the functional relationship between the dose and pharmacokinetic endpoint AUC tau,ss||Dose proportionality was analysed over the dose range 10 to 50 mg for plasma PK parameters based on a power model||1.3759|1.0519|
70876874|NCT02028065|141238006|SUPERIORITY_OR_OTHER||Difference in incidence|5.3|||||TWO_SIDED|95.0|-0.9|10.7|||||Difference is Sugammadex 4 mg/kg incidence minus Placebo incidence. Confidence interval calculated using method of Miettinen and Nurminen (Statistics in Medicine 1985;4:213-226).|Planned sample size of 150 participants in each sugammadex group (4 mg/kg and 16 mg/kg) allowed estimation of adjudicated hypersensitivity in each sugammadex group with a 95% confidence interval with a half-width between 1.2 and 4.2 percentage points. Calculation, based on method of Clopper and Pearson (Biometrika 1934;26\[4\]:404-413), used underlying event rate of up to 6% in the sugammadex high dose group, based on study results from protocol P06042 (NCT00988065).||10.7|-0.9|
70876875|NCT02028065|141238006|SUPERIORITY_OR_OTHER||Difference in incidence|8.1|||||TWO_SIDED|95.0|1.7|14.2|||||Difference is Sugammadex 16 mg/kg incidence minus Placebo incidence. Confidence interval calculated using method of Miettinen and Nurminen(Statistics in Medicine 1985;4:213-226).|Planned sample size of 150 participants in each sugammadex group (4 mg/kg and 16 mg/kg) allowed estimation of adjudicated hypersensitivity in each sugammadex group with a 95% confidence interval with a half-width between 1.2 and 4.2 percentage points. Calculation, based on method of Clopper and Pearson (Biometrika 1934;26\[4\]:404-413), used underlying event rate of up to 6% in the sugammadex high dose group, based on study results from protocol P06042 (NCT00988065).||14.2|1.7|
70876876|NCT02028065|141238007|SUPERIORITY_OR_OTHER||Difference in incidence|0.0|||||TWO_SIDED|95.0|-4.8|2.5|||||Difference is Sugammadex 4 mg/kg incidence minus Placebo incidence. Confidence interval calculated using method of Miettinen and Nurminen (Statistics in Medicine 1985;4:213-226).|||2.5|-4.8|
70876877|NCT02028065|141238007|SUPERIORITY_OR_OTHER||Difference in incidence|0.7|||||TWO_SIDED|95.0|-4.2|3.7|||||Difference is Sugammadex 16 mg/kg incidence minus Placebo incidence. Confidence interval calculated using method of Miettinen and Nurminen (Statistics in Medicine 1985;4:213-226).|||3.7|-4.2|
70876878|NCT00867009|141238024|SUPERIORITY_OR_OTHER||Percentage of participants with response|38.5|||||TWO_SIDED|80.0|32.3|45.09||||||||45.09|32.30|
70876879|NCT00867009|141238025|SUPERIORITY_OR_OTHER||Median number of months|5.82|||||TWO_SIDED|80.0|4.4|6.7||||||||6.70|4.40|
70876880|NCT00867009|141238026|SUPERIORITY_OR_OTHER||Percentage of participants with response|45.0|||||TWO_SIDED|80.0|39.0|51.0||||||||51|39|
70876881|NCT00867009|141238027|SUPERIORITY_OR_OTHER||Percentage of participants with response|59.6|||||TWO_SIDED|80.0|53.06|65.94||||||||65.94|53.06|
70876882|NCT00147199|141238041|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate|20.0||||0.00044|TWO_SIDED|95.0|8.0|32.8|||ANCOVA|Lowest rank was assigned for death, discontinuation due to disease progression, and for patients who initiated additional approved PAH therapy.||Sample size was calculated based on the primary endpoint; change in 6MWD at Week 12. Assuming a between-treatment difference of 35m, a standard deviation of 75m, and a type I (alpha) error of 0.05 (i.e., two-sided p-value of less than 0.05), in order to have 90% power to detect this difference, 100 subjects per treatment group were required for this trial (total n=200). This allowed for a dropout rate of 10% as 110 subjects per group was planned.||32.8|8.0|0.00044
70876883|NCT00147199|141238043|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|0.0||||0.623|TWO_SIDED|95.0|-0.5|0.0|||Wilcoxon rank sum test|||||0.0|-0.5|0.623
70957122|NCT04187989|141418290|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.078|STANDARD_ERROR_OF_MEAN|0.175||0.656|TWO_SIDED|95.0|-0.425|0.269|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.269|-.425|.656
70957123|NCT04187989|141418291|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.339|STANDARD_ERROR_OF_MEAN|0.205||0.158|TWO_SIDED|95.0|-0.746|0.067||The p-value is for the coefficient of the treatment/control indicator in the above mixed model|t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|||0.067|-.746|.158
70957124|NCT04187989|141418292|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|0.143|STANDARD_ERROR_OF_MEAN|0.178||0.422|TWO_SIDED|95.0|-0.21|0.495|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.495|-.210|.422
70957125|NCT04187989|141418293|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|0.027|STANDARD_ERROR_OF_MEAN|0.179||0.882|TWO_SIDED|95.0|-0.328|0.381|||t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs||.381|-.328|.882
70957126|NCT04187989|141418294|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.197|STANDARD_ERROR_OF_MEAN|0.268||0.497|TWO_SIDED|95.0|-0.728|0.334||The p-value is for the coefficient of the treatment/control indicator in the above mixed model|t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.334|-.728|.497
70957127|NCT04187989|141418295|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.042|STANDARD_ERROR_OF_MEAN|0.18||0.813|TWO_SIDED|95.0|-0.398|0.313||The p-value is for the coefficient of the treatment/control indicator in the above mixed model|t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.313|-.398|.813
70957128|NCT04187989|141418296|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.034|STANDARD_ERROR_OF_MEAN|0.176||0.849|TWO_SIDED|95.0|-0.381|0.314||The p-value is for the coefficient of the treatment/control indicator in the above mixed model|t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.314|-.381|.849
70957129|NCT04187989|141418297|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.118|STANDARD_ERROR_OF_MEAN|0.247||0.667|TWO_SIDED|95.0|-0.607|0.371||The p-value is for the coefficient of the treatment/control indicator in the above mixed model|t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.371|-.607|.667
70957130|NCT04187989|141418298|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.342|STANDARD_ERROR_OF_MEAN|0.175||0.051|TWO_SIDED|95.0|-0.689|0.005|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs||.005|-.689|.051
70876884|NCT00147199|141238044|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|0.0||||0.807|TWO_SIDED|95.0|0.0|0.0||Imputation strategies were implemented for 16 inhaled treprostinil subjects and 9 placebo subjects without values reported at Week 12|Wilcoxon rank sum test|||||0.0|0.0|0.807
70876885|NCT00147199|141238045|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|13.7||||0.007|TWO_SIDED|95.0|4.0|24.8|||ANCOVA|||||24.8|4.0|0.007
70876886|NCT00147199|141238046|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|18.5||||0.0003|TWO_SIDED|95.0|8.5|28.3|||Wilcoxon rank sum test|||||28.3|8.5|0.0003
70876887|NCT00147199|141238047|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman Estimate|-4.0||||0.027|TWO_SIDED|95.0|-8.0|0.0|||Wilcoxon rank sum test|||Global Score||0|-8.0|0.027
70876888|NCT00147199|141238047|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman Estimate|-2.0||||0.037|TWO_SIDED|95.0|-3.0|0.0|||Wilcoxon rank sum test|||Physical Dimension||0.0|-3.0|0.037
70957131|NCT04187989|141418299|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.064|STANDARD_ERROR_OF_MEAN|0.176||0.714|TWO_SIDED|95.0|-0.412|0.284|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model||We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|.284|-.412|.714
70957132|NCT04187989|141418300|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.11|STANDARD_ERROR_OF_MEAN|0.212||0.603|TWO_SIDED|95.0|-0.531|0.311|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|: We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.311|-.531|.603
70957133|NCT04187989|141418301|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|0.162|STANDARD_ERROR_OF_MEAN|0.219||0.457|TWO_SIDED|95.0|-0.273|0.597|||Cohen's D|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects)|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.597|-.273|.457
70957134|NCT04187989|141418302|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.265|STANDARD_ERROR_OF_MEAN|0.212||0.209|TWO_SIDED|95.0|-0.686|0.156|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.156|-.686|.209
70957135|NCT04187989|141418303|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.107|STANDARD_ERROR_OF_MEAN|0.219||0.623|TWO_SIDED|95.0|-0.541|0.328|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects)|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.328|-.541|.623
70957136|NCT00092495|141418318|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (girls - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
70957137|NCT00092495|141418318|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (boys - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
70957138|NCT00092495|141418319|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (girls/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
70957139|NCT00092495|141418319|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (boys/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
70957140|NCT00092495|141418320|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
70957141|NCT00092495|141418320|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
70957142|NCT00092495|141418320|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
70876889|NCT00147199|141238047|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman Estimate|-1.0||||0.173|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon rank sum test|||Emotional Dimension Score||0.0|-2.0|0.173
70876890|NCT00147199|141238049|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman Estimate|-167.0||||0.001|TWO_SIDED|95.0|-333.0|-64.0|||Wilcoxon rank sum test|||||-64|-333|0.001
70876891|NCT01850524|141238050|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.073|TWO_SIDED|95.0|0.676|1.018|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.||||1.018|0.676|0.073
70876892|NCT01850524|141238051|SUPERIORITY||Hazard Ratio (HR)|0.998||||0.988|TWO_SIDED|95.0|0.79|1.261|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an Unadjusted Cox's proportional hazard regression model is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|||1.261|0.790|0.988
70957143|NCT00092495|141418321|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
70957144|NCT00092495|141418321|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
70957145|NCT00092495|141418321|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
70876893|NCT01850524|141238052|SUPERIORITY||Odds Ratio (OR)|2.1|||<|0.001|TWO_SIDED|95.0|1.43|3.09|||Cochran-Mantel-Haenszel|CMH test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Odds ratio and confidence interval are based on logistic regression model with treatment group as categorical predictor variable,age(\<75 years vs \>=75), ISS(stage I or II vs stage III),and BPI-SF worst pain score(\<4 vs \>=4)at screening as covariates.|||3.09|1.43|<0.001
70876894|NCT01850524|141238053|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9195|TWO_SIDED|95.0|0.656|1.463|||Regression, Logistic|Logistic regression model with prognostic factor: age (\<75 years vs \>=75) and ISS (stage I or II vs stage III).|Odds ratio \> 1 favors Ixazomib+LenDex versus LenDex alone.|||1.463|0.656|0.9195
70957146|NCT00092495|141418322|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (girls - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
70876895|NCT01850524|141238054|SUPERIORITY||Odds Ratio (OR)|1.16||||0.436|TWO_SIDED|95.0|0.79|1.7|||Cochran-Mantel-Haenszel|CMH test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Odds ratio and confidence interval are based on logistic regression model with treatment group as categorical predictor variable,age(\<75 years vs \>=75), ISS(stage I or II vs stage III),and BPI-SF worst pain score(\<4 vs \>=4)at screening as covariates.|||1.70|0.79|0.436
70876896|NCT01850524|141238055|SUPERIORITY||Hazard Ratio (HR)|1.402|||<|0.001|TWO_SIDED|95.0|1.185|1.659|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|||1.659|1.185|<0.001
70876897|NCT01850524|141238057|SUPERIORITY||Hazard Ratio (HR)|0.738||||0.008|TWO_SIDED|95.0|0.589|0.925|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|||0.925|0.589|0.008
70876898|NCT01850524|141238058|SUPERIORITY||Hazard Ratio (HR)|0.859||||0.189|TWO_SIDED|95.0|0.684|1.078|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|||1.078|0.684|0.189
70876899|NCT01850524|141238064|SUPERIORITY||Hazard Ratio (HR)|1.118||||0.662|TWO_SIDED|95.0|0.678|1.845|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|OS in High-risk Population Carrying Del(17p), Amp(1q21), t(4;14), or t(14;16) Mutations||1.845|0.678|0.662
70876900|NCT01850524|141238065|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.271|TWO_SIDED|95.0|0.466|1.24|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|PFS in High-risk Population Carrying del(17p), t(4;14), or t(14;16) Mutations||1.240|0.466|0.271
70876901|NCT01850524|141238067|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.26|TWO_SIDED|95.0|0.661|1.12|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Time to Pain Progression||1.120|0.661|0.260
70876902|NCT00459667|141238095|SUPERIORITY_OR_OTHER||Number of patients w/ Flu-Like-Syndrome|17.4||||||95.0|14.4|20.7||||||The 95% Confidence Interval was calculated for number of patients w/ Flu-Like-Syndrome||20.7|14.4|
70876903|NCT00459667|141238095|SUPERIORITY_OR_OTHER||Number of patients w/ Flu-Like-Syndrome|15.8||||||95.0|13.1|18.9||||||The 95% Confidence Interval was calculated for number of patients w/ Flu-Like-Syndrome||18.9|13.1|
70876904|NCT00459667|141238095|SUPERIORITY_OR_OTHER||Number of patients w/ Flu-Like-Syndrome|31.1||||||95.0|24.4|38.4||||||The 95% Confidence Interval was calculated for number of patients w/ Flu-Like-Syndrome||38.4|24.4|
70876905|NCT00459667|141238096|SUPERIORITY_OR_OTHER||number of patients w/ IS reactions.|31.7||||||95.0|28.0|35.7||||||The 95% Confidence Interval was calculated for number of patients w/ Injection-site (IS) reactions.||35.7|28.0|
70876906|NCT00459667|141238096|SUPERIORITY_OR_OTHER||number of patients w/ IS reactions.|26.2||||||95.0|22.8|29.8||||||The 95% Confidence Interval was calculated for number of patients w/ Injection-site (IS) reactions.||29.8|22.8|
70876907|NCT00459667|141238096|SUPERIORITY_OR_OTHER||number of patients w/ IS reactions.|31.7||||||95.0|24.9|39.0||||||The 95% Confidence Interval was calculated for number of patients w/ Injection-site (IS) reactions.||39.0|24.9|
70876908|NCT00556712|141238101|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.62|0.82|||Log Rank|||||0.82|0.62|<0.0001
70876909|NCT00556712|141238105|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0097|TWO_SIDED|95.0|0.72|0.96|||Log Rank|||||0.96|0.72|0.0097
70876910|NCT00556712|141238108|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.005|TWO_SIDED|95.0|0.66|0.93|||Log Rank|||||0.93|0.66|0.0050
70876911|NCT00556712|141238111|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.1768|TWO_SIDED|95.0|0.51|1.14|||Log Rank|||||1.14|0.51|0.1768
70876912|NCT00556712|141238114|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.4797|TWO_SIDED|95.0|0.49|1.4|||Log Rank|||||1.40|0.49|0.4797
70876913|NCT00556712|141238116|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7|||<|0.0001|TWO_SIDED|95.0|0.61|0.82|||Log Rank|||||0.82|0.61|<0.0001
70876914|NCT00556712|141238118|SUPERIORITY_OR_OTHER||Difference in Response Rates|6.53||||0.0006|TWO_SIDED|95.0|2.7|10.3|||Chi-squared||The approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.|||10.3|2.7|0.0006
70876915|NCT00556712|141238120|SUPERIORITY_OR_OTHER||Difference in Response Upgrade Rates|4.2||||0.0007|TWO_SIDED|95.0|1.6|6.7|||Chi-squared||The approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.|||6.7|1.6|0.0007
70876916|NCT00556712|141238122|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|9.8||||0.0035|TWO_SIDED|95.0|3.1|16.4|||Chi-squared||Approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.|Analysis included CR + PR + SD rate.||16.4|3.1|0.0035
70876917|NCT00556712|141238122|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|13.4|||<|0.0001|TWO_SIDED|95.0|7.1|19.7|||Chi-squared||Approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.|Analysis included CR + PR + SD \> 12 weeks rate.||19.7|7.1|<0.0001
70876918|NCT00556712|141238124|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.3787|TWO_SIDED|95.0|0.74|1.12|||Log Rank|||||1.12|0.74|0.3787
70876919|NCT00556712|141238126|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.58|0.82|||Log Rank|||||0.82|0.58|< 0.0001
70876920|NCT00556712|141238129|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.5385|TWO_SIDED|95.0|0.87|1.31|||Log Rank|||||1.31|0.87|0.5385
70876921|NCT00556712|141238132|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.653|TWO_SIDED|95.0|0.79|1.16|||Log Rank|||||1.16|0.79|0.6530
70876922|NCT00353262|141238146|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.9|||||TWO_SIDED|90.0|0.79|1.02||||||Cycle 2, Day 1 versus Cycle 1, Day 1||1.02|0.79|
70876923|NCT00353262|141238146|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.76|0.99||||||Cycle 3, Day 1 versus Cycle 1, Day 1||0.99|0.76|
70876924|NCT00353262|141238146|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.85|1.1||||||Cycle 3, Day 1 to Cycle 2, Day 1||1.10|0.85|
70876925|NCT00353262|141238147|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.05|||||TWO_SIDED|90.0|1.01|1.08||||||Cycle 2, Day 1 versus Cycle 1, Day 2||1.08|1.01|
70876926|NCT00353262|141238147|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.02|||||TWO_SIDED|90.0|0.98|1.05||||||Cycle 3, Day 1 to Cycle 1, Day 2||1.05|0.98|
70876927|NCT00353262|141238147|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.94|1.0||||||Cycle 3, Day 1 to Cycle 2, Day 1||1.00|0.94|
70876928|NCT00353262|141238148|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.02|||||TWO_SIDED|90.0|0.83|1.24||||||Capecitabine: Cycle 2, Day 1 versus Cycle 1, Day 1||1.24|0.83|
70876929|NCT00353262|141238148|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.16|||||TWO_SIDED|90.0|0.94|1.42||||||Capecitabine: Cycle 3, Day 1 to Cycle 2, Day 1||1.42|0.94|
70876930|NCT00353262|141238148|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.17|||||TWO_SIDED|90.0|0.96|1.44||||||Capecitabine: Cycle 3, Day 1 to Cycle 1, Day 1||1.44|0.96|
70876931|NCT00353262|141238148|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.86|||||TWO_SIDED|90.0|0.69|1.08||||||5'-DFCR: Cycle 2, Day 1 versus Cycle 1, Day 1||1.08|0.69|
70876932|NCT00353262|141238148|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.08|||||TWO_SIDED|90.0|0.86|1.34||||||5'-DFCR: Cycle 3, Day 1 versus Cycle 1, Day 1||1.34|0.86|
70876933|NCT00353262|141238148|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.25|||||TWO_SIDED|90.0|1.0|1.55||||||5'-DFCR: Cycle 3, Day 1 versus Cycle 2, Day 1||1.55|1.00|
70876934|NCT00353262|141238148|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.81|||||TWO_SIDED|90.0|0.66|1.01||||||5-FU: Cycle 2, Day 1 versus Cycle 1, Day 1||1.01|0.66|
70957147|NCT00092495|141418322|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (boys - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
70876935|NCT00353262|141238148|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.79|||||TWO_SIDED|90.0|0.64|0.97||||||5-FU: Cycle 3, Day 1 versus Cycle 1, Day 1||0.97|0.64|
70876936|NCT00353262|141238148|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.78|1.19||||||5-FU: Cycle 3, Day 1 versus Cycle 2, Day 1||1.19|0.78|
70876937|NCT00353262|141238148|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.91|1.04||||||FBAL: Cycle 2, Day 1 versus Cycle 1, Day 1||1.04|0.91|
70876938|NCT00353262|141238148|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.9|1.04||||||FBAL: Cycle 3, Day 1 versus Cycle 1, Day 1||1.04|0.90|
70876939|NCT00353262|141238148|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.93|1.07||||||FBAL: Cycle 3, Day 1 versus Cycle 2, Day 1||1.07|0.93|
70876940|NCT00353262|141238150|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.74|||||TWO_SIDED|90.0|0.61|0.9||||||5'-DFUR: Cycle 2, Day 1 versus Cycle 1, Day 1||0.90|0.61|
70876941|NCT00353262|141238150|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.64|||||TWO_SIDED|90.0|0.53|0.79||||||5'-DFUR: Cycle 3, Day 1 versus Cycle 1, Day 1||0.79|0.53|
70876942|NCT00353262|141238150|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.71|1.06||||||5'-DFUR: Cycle 3, Day 1 versus Cycle 2, Day 1||1.06|0.71|
70876943|NCT00353262|141238150|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.82|||||TWO_SIDED|90.0|0.63|1.08||||||Capecitabine: Cycle 2, Day 1 versus Cycle 1, Day 1||1.08|0.63|
70876944|NCT00353262|141238150|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.03|||||TWO_SIDED|90.0|0.78|1.34||||||Capecitabine: Cycle 3, Day 1 versus Cycle 2, Day 1||1.34|0.78|
70876945|NCT00353262|141238150|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.85|||||TWO_SIDED|90.0|0.65|1.1||||||Capecitabine: Cycle 3, Day 1 versus Cycle 1, Day 1||1.10|0.65|
70876946|NCT00353262|141238150|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.65|1.18||||||5'-DFCR: Cycle 2, Day 1 versus Cycle 1, Day 1||1.18|0.65|
70876947|NCT00353262|141238150|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.96|||||TWO_SIDED|90.0|0.71|1.3||||||5'-DFCR: Cycle 3, Day 1 versus Cycle 1, Day 1||1.30|0.71|
70876948|NCT00353262|141238150|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.1|||||TWO_SIDED|90.0|0.81|1.49||||||5'-DFCR: Cycle 3, Day 1 versus Cycle 2, Day 1||1.49|0.81|
70876949|NCT00353262|141238150|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.74|||||TWO_SIDED|90.0|0.56|0.98||||||5-FU: Cycle 2, Day 1 versus Cycle 1, Day 1||0.98|0.56|
70876950|NCT00353262|141238150|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.58|||||TWO_SIDED|90.0|0.44|0.76||||||5-FU: Cycle 3, Day 1 versus Cycle 1, Day 1||0.76|0.44|
70876951|NCT00353262|141238150|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.78|||||TWO_SIDED|90.0|0.59|1.03||||||5-FU: Cycle 3, Day 1 versus Cycle 2, Day 1||1.03|0.59|
70876952|NCT00353262|141238150|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.91|||||TWO_SIDED|90.0|0.83|1.0||||||FBAL: Cycle 2, Day 1 versus Cycle 1, Day 1||1.00|0.83|
70876953|NCT00353262|141238150|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.83|||||TWO_SIDED|90.0|0.76|0.91||||||FBAL: Cycle 3, Day 1 versus Cycle 1, Day 1||0.91|0.76|
70876954|NCT00353262|141238150|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.91|||||TWO_SIDED|90.0|0.83|1.0||||||FBAL: Cycle 3, Day 1 versus Cycle 2, Day 1||1.00|0.83|
70876955|NCT00353262|141238152|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.2|||||TWO_SIDED|90.0|1.09|1.33||||||Total Platinum: Cycle 2, Day 1 versus Cycle 1, Day 2||1.33|1.09|
70876956|NCT00353262|141238152|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.34|||||TWO_SIDED|90.0|1.21|1.48||||||Total Platinum: Cycle 3, Day 1 versus Cycle 1, Day 2||1.48|1.21|
70876957|NCT00353262|141238152|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.11|||||TWO_SIDED|90.0|1.01|1.23||||||Total Platinum: Cycle 3, Day 1 versus Cycle 2, Day 1||1.23|1.01|
70876958|NCT00353262|141238154|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.02|||||TWO_SIDED|90.0|0.96|1.09||||||Total Platinum: Cycle 2, Day 1 versus Cycle 1, Day 2||1.09|0.96|
70876959|NCT00353262|141238154|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.01|||||TWO_SIDED|90.0|0.95|1.08||||||Total Platinum: Cycle 3, Day 1 versus Cycle 1, Day 2||1.08|0.95|
70876960|NCT00353262|141238154|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.93|1.05||||||Total Platinum: Cycle 3, Day 1 versus Cycle 2, Day 1||1.05|0.93|
70876961|NCT00353262|141238154|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.01|||||TWO_SIDED|90.0|0.94|1.09||||||Free Platinum: Cycle 2, Day 1 versus Cycle 1, Day 2||1.09|0.94|
70957148|NCT00092495|141418323|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (girls/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group||||||<0.001
70957149|NCT00092495|141418323|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (boys/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group||||||<0.001
70957150|NCT00092495|141418324|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
70957151|NCT00092495|141418324|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
70957152|NCT00092495|141418324|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
70957153|NCT00092495|141418325|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
70957154|NCT00092495|141418325|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group||||||<0.001
70957155|NCT00092495|141418325|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
70957156|NCT00092495|141418326|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (girls - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
70957157|NCT00092495|141418326|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (boys - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
70957158|NCT00092495|141418327|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (girls/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
70957159|NCT00092495|141418327|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (boys/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
70957160|NCT00092495|141418328|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.01||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.01
70876962|NCT00353262|141238154|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.92|1.08||||||Free Platinum: Cycle 3, Day 1 versus Cycle 1, Day 2||1.08|0.92|
70876963|NCT00353262|141238154|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.91|1.07||||||Free Platinum: Cycle 3, Day 1 versus Cycle 2, Day 1||1.07|0.91|
70876964|NCT02723084|141238231|NON_INFERIORITY|The percentage of participants achieving SVR12 was calculated for each arm and a 2- sided 95% confidence interval (CI) for the difference in SVR12 rates (Arm A minus Arm B) was calculated using the normal approximation to the binomial distribution to assess non-inferiority in SVR12 rates of arm A to arm B. If the lower bound of the CI for the difference was above the noninferiority margin of -10%, then arm A was considered non-inferior to arm B.|Risk Difference (RD)|4.3|||||TWO_SIDED|95.0|-3.5|12.1|||||95% CI was calculated using the normal approximation to the binomial distribution.|Difference in SVR12 rates (Arm A - Arm B)||12.1|-3.5|
70876965|NCT01409564|141238257|SUPERIORITY_OR_OTHER|||||||0.14|||||||Repeated ANOVA|Uncorrected, Repeated ANOVA||Repeated-measures analysis of variance (ANOVA) was used to test group\*time interaction effect in glucose uptake of Left Parietal Lobe in two groups on two data points (baseline, 24-week).||||0.14
70957161|NCT00092495|141418328|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
70957162|NCT00092495|141418328|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
70957163|NCT00092495|141418329|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
70957164|NCT00092495|141418329|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
70957165|NCT00092495|141418329|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
70957166|NCT00092495|141418330|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (girls - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
70957167|NCT00092495|141418330|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (boys - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
70876966|NCT01409564|141238257|SUPERIORITY_OR_OTHER|||||||0.08|||||||Repeated ANOVA|||Repeated-measures analysis of variance (ANOVA) was used to test group\*time interaction effect in glucose uptake of Right Parietal Lobe in two groups on two data points (baseline, 24-week).||||0.08
70876967|NCT01409564|141238257|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Repeated ANOVA|||Repeated-measures analysis of variance (ANOVA) was used to test group\*time interaction effect in glucose uptake of Left Inferior Frontal Gyrus in two groups on two data points (baseline, 24-week).||||<0.01
70876968|NCT01409564|141238257|SUPERIORITY_OR_OTHER|||||||0.08|||||||Repeated ANOVA|||Repeated-measures analysis of variance (ANOVA) was used to test group\*time interaction effect in glucose uptake of Right Inferior Frontal Gyrus in two groups on two data points (baseline, 24-week).||||0.08
70876969|NCT01409564|141238258|SUPERIORITY_OR_OTHER|||||||0.93|||||||Repeated ANOVA|||Repeated ANOVA, tested for group\*time interaction effect of ADAS-Cog scores on three data points (Baseline, 12-week, 24-week)||||0.93
70876970|NCT01409564|141238259|SUPERIORITY_OR_OTHER|||||||0.15|||||||Repeated ANOVA|||Repeated ANOVA, tested for group\*time interaction effect of MMSE scores on three data points (Baseline, 12-week, 24-week)||||0.15
70876971|NCT01409564|141238260|SUPERIORITY_OR_OTHER|||||||0.82|||||||Repeated ANOVA|||Repeated ANOVA, tested for group\*time interaction effect of ADCS-ADL scores on three data points (Baseline, 12-week, 24-week)||||0.82
70876972|NCT01409564|141238261|SUPERIORITY_OR_OTHER|||||||0.79|||||||Chi-squared|||Repeated ANOVA, tested for group\*time interaction effect of Summed CDR scores on three data points (Baseline, 12-week, 24-week)||||0.79
70876973|NCT01409564|141238262|SUPERIORITY_OR_OTHER|||||||0.87|||||||Chi-squared|||Distribution of Fazekas scale in two groups according to Chi-square test results.||||0.87
70876974|NCT02328755|141238270|OTHER|Single group|cumulative incidence|0.39|||||TWO_SIDED|95.0|0.24|0.58||||||The analysis applies only to the first row, for recipients of HLA-matched HCT who received the phase II MTD (180mcg) peg-IFN-a (n=31).||0.58|0.24|
70957168|NCT00092495|141418331|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (girls/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
70876975|NCT02328755|141238271|OTHER|Single group|Kaplan-Meier|55.0|||||TWO_SIDED|95.0|40.0|75.0||||||The analysis applies only to the first row, data at 6 months, for recipients of HLA-matched HCT who received the phase II MTD (180mcg) peg-IFN-a (n=31).|Survival proportion estimates at 6 months and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method.|75|40|
70876976|NCT02328755|141238271|OTHER|Single group|Kaplan-Meier|33.0|||||TWO_SIDED|95.0|19.0|58.0||||||The analysis applies only to the 3rd row, data at 24 months, for recipients of HLA-matched HCT who received the phase II MTD (180mcg) peg-IFN-a (n=31).|Survival proportion estimates at 6 months and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method.|58|19|
70876977|NCT02328755|141238272|OTHER|Single group|||||||||||||||||Survival proportion estimates at 6 months and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method.|||
70876978|NCT02328755|141238273|OTHER|Single group|||||||||||||||||GVHD proportion estimates and corresponding 95% confidence intervals were calculated using methods of Fine and Gray.|||
70876979|NCT02328755|141238274|OTHER|Single group|||||||||||||||||Non-relapse mortality estimates and corresponding 95% confidence intervals were calculated using methods of Fine and Gray.|||
70876980|NCT04309656|141238362|EQUIVALENCE|Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.|Geometric mean ratio (%)|85.85||||0.0001|TWO_SIDED|90.0|81.21|90.75|||ANOVA|||||90.75|81.21|0.0001
70876981|NCT04309656|141238362|EQUIVALENCE|Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.|Geometric mean ratio (%)|92.99||||0.3001|TWO_SIDED|90.0|82.65|104.62|||ANOVA|||||104.62|82.65|0.3001
70876982|NCT04309656|141238363|EQUIVALENCE|Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.|Geometric mean ratio (%)|100.6||||0.6686|TWO_SIDED|90.0|98.23|103.03|||ANOVA|||||103.03|98.23|0.6686
70876983|NCT04309656|141238363|EQUIVALENCE|Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.|Geometric mean ratio (%)|89.7||||0.0745|TWO_SIDED|90.0|81.2|99.1|||ANOVA|||||99.10|81.20|0.0745
70876984|NCT04309656|141238364|EQUIVALENCE|Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.|Geometric mean ratio (%)|101.03||||0.4683|TWO_SIDED|90.0|98.65|103.47|||ANOVA|||||103.47|98.65|0.4683
70876985|NCT04309656|141238364|EQUIVALENCE|Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.|Geometric mean ratio (%)|89.63||||0.0734|TWO_SIDED|90.0|81.1|99.05|||ANOVA|||||99.05|81.10|0.0734
70957169|NCT00092495|141418331|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (boys/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
70876986|NCT03720470|141238369|SUPERIORITY||Difference in percentage|23.1|||<|0.0001|TWO_SIDED|95.0|14.7|31.4|||Cochran-Mantel-Haenszel|||Difference in percentage (PF-04965842 versus placebo) and confidence interval (CI) for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||31.4|14.7|<0.0001
70876987|NCT03720470|141238369|SUPERIORITY||Difference in Percentage|34.8|||<|0.0001|TWO_SIDED|95.0|26.1|43.5|||Cochran-Mantel-Haenszel|||Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||43.5|26.1|<0.0001
70876988|NCT03720470|141238370|SUPERIORITY||Difference in percentage|31.9|||<|0.0001|TWO_SIDED|95.0|22.2|41.6|||Cochran-Mantel-Haenszel|||Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||41.6|22.2|<0.0001
70876989|NCT03720470|141238370|SUPERIORITY||Difference in Percentage|43.2|||<|0.0001|TWO_SIDED|95.0|33.7|52.7|||Cochran-Mantel-Haenszel|||Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||52.7|33.7|<0.0001
70876990|NCT03720470|141238371|SUPERIORITY||Difference in percentage|17.9||||0.0002|TWO_SIDED|95.0|9.5|26.3|||Cochran-Mantel-Haenszel|||Week 2: Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||26.3|9.5|0.0002
70876991|NCT03720470|141238371|SUPERIORITY||Difference in Percentage|34.9|||<|0.0001|TWO_SIDED|95.0|26.0|43.7|||Cochran-Mantel-Haenszel|||Week 2: Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||43.7|26.0|<.0001
70876992|NCT03720470|141238371|SUPERIORITY||Difference in Percentage|5.2||||0.2084|TWO_SIDED|95.0|-2.9|13.4|||Cochran-Mantel-Haenszel|||Week 2: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||13.4|-2.9|0.2084
70876993|NCT03720470|141238371|SUPERIORITY||Difference in Percentage|22.1|||<|0.0001|TWO_SIDED|95.0|13.5|30.7|||Cochran-Mantel-Haenszel|||Week 2: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||30.7|13.5|<0.0001
70876994|NCT03720470|141238372|OTHER||Difference in Percentage|22.1|||<|0.0001|TWO_SIDED|95.0|13.7|30.5|||Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||30.5|13.7|<0.0001
70876995|NCT03720470|141238372|OTHER||Difference in Percentage|35.0|||<|0.0001|TWO_SIDED|95.0|26.3|43.7|||Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||43.7|26.3|<0.0001
70876996|NCT03720470|141238372|OTHER||Difference in Percentage|-3.5|||||TWO_SIDED|95.0|-12.2|5.2||||||Week 16: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||5.2|-12.2|
70876997|NCT03720470|141238372|OTHER||Difference in Percentage|9.4|||||TWO_SIDED|95.0|0.4|18.5||||||Week 16: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||18.5|0.4|
70876998|NCT03720470|141238373|OTHER||Difference in percentage|24.1|||<|0.0001|TWO_SIDED|95.0|14.0|34.1|||Cochran-Mantel-Haenszel|||Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||34.1|14.0|<0.0001
70876999|NCT03720470|141238373|OTHER||Difference in Percentage|30.1|||<|0.0001|TWO_SIDED|95.0|20.3|39.8|||Cochran-Mantel-Haenszel|||Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||39.8|20.3|<0.0001
70877000|NCT03720470|141238373|OTHER||Difference in Percentage|-2.7|||||TWO_SIDED|95.0|-9.6|4.2||||||Week 16: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||4.2|-9.6|
70877001|NCT03720470|141238373|OTHER||Difference in Percentage|3.1|||||TWO_SIDED|95.0|-3.3|9.6||||||Week 16: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||9.6|-3.3|
70877002|NCT00453921|141238400|OTHER||||||<|0.04||||||For active therapy/placebo relative to both placebo|Kruskal-Wallis|||||||<0.04
70877003|NCT00453921|141238402|EQUIVALENCE|Looking for statistical difference, p \< .01, between groups looking at change scores|||||<|0.05|||||||ANOVA|||||||<0.05
70877004|NCT00453921|141238403|EQUIVALENCE|group differences|||||<|0.05|||||||ANCOVA|||||||<0.05
70877005|NCT00453921|141238406|OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
70877006|NCT00453921|141238406|SUPERIORITY||||||<|0.05||||||a priopr|ANCOVA|||||||<0.05
70877007|NCT02772081|141238427|SUPERIORITY||Adjusted difference|-15.4||||0.39|TWO_SIDED|95.0|-47.9|17.1|||Cochran-Mantel-Haenszel|||First Administration; Treatment comparison. Adjusted difference, its 95% confidence interval (CI) and p-value are estimated using Cochran-Mantel-Haenszel test||17.1|-47.9|0.390
70877008|NCT02772081|141238433|SUPERIORITY||Median Difference (Final Values)|5.0||||0.563|TWO_SIDED|95.0|-13.8|23.8|||Wilcoxon (Mann-Whitney)|||Duration of standalone oxygen supplementation||23.8|-13.8|0.563
70877009|NCT02772081|141238433|SUPERIORITY||Median Difference (Final Values)|1.0||||0.612|TWO_SIDED|95.0|-19.7|21.7|||Wilcoxon (Mann-Whitney)|||Duration of NIV||21.7|-19.7|0.612
70957170|NCT00092495|141418332|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
70877010|NCT02772081|141238436|SUPERIORITY||Adjusted mean difference|-0.619||||0.137|TWO_SIDED|95.0|-1.447|0.21|||Mixed model for repeated measures|||T0, Treatment comparison. The analysis was based on an mixed model for repeated measures (MMRM) with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.210|-1.447|0.137
70877011|NCT02772081|141238436|SUPERIORITY||Adjusted mean difference|0.268||||0.534|TWO_SIDED|95.0|-0.604|1.14|||Mixed model for repeated measures|||5 min, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||1.140|-0.604|0.534
70877012|NCT02772081|141238436|SUPERIORITY||Adjusted mean difference|0.27||||0.53|TWO_SIDED|95.0|-0.597|1.136|||Mixed model for repeated measures|||15 min, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||1.136|-0.597|0.530
70877013|NCT02772081|141238436|SUPERIORITY||Adjusted mean difference|0.641||||0.091|TWO_SIDED|95.0|-0.108|1.389|||Mixed model for repeated measures|||30 min, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||1.389|-0.108|0.091
70877014|NCT02772081|141238436|SUPERIORITY||Adjusted mean difference|0.463||||0.04|TWO_SIDED|95.0|0.023|0.903|||Mixed model for repeated measures|||1 hour, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.903|0.023|0.040
70877015|NCT02772081|141238436|SUPERIORITY||Adjusted mean difference|0.166||||0.532|TWO_SIDED|95.0|-0.371|0.703|||Mixed model for repeated measures|||6 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.703|-0.371|0.532
70877016|NCT02772081|141238436|SUPERIORITY||Adjusted mean difference|0.048||||0.877|TWO_SIDED|95.0|-0.578|0.674|||Mixed model for repeated measures|||12 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.674|-0.578|0.877
70877017|NCT02772081|141238436|SUPERIORITY||Adjusted mean difference|0.244||||0.356|TWO_SIDED|95.0|-0.289|0.776|||Mixed model for repeated measures|||24 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.776|-0.289|0.356
70877018|NCT02772081|141238436|SUPERIORITY||Adjusted mean difference|0.303||||0.258|TWO_SIDED|95.0|-0.235|0.841|||Mixed model for repeated measures|||48 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.841|-0.235|0.258
70877019|NCT02772081|141238436|SUPERIORITY||Adjusted mean difference|0.022||||0.945|TWO_SIDED|95.0|-0.616|0.66|||Mixed model for repeated measures|||72 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.660|-0.616|0.945
70877020|NCT02772081|141238436|SUPERIORITY||Adjusted mean difference|-0.075||||0.766|TWO_SIDED|95.0|-0.586|0.436|||Mixed model for repeated measures|||120 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.436|-0.586|0.766
70877021|NCT02772081|141238437|SUPERIORITY||Adjusted mean difference|0.051||||0.59|TWO_SIDED|95.0|-0.141|0.243|||Mixed model for repeated measures|||T0, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.243|-0.141|0.590
70877022|NCT02772081|141238437|SUPERIORITY||Adjusted mean difference|-0.051||||0.511|TWO_SIDED|95.0|-0.21|0.107|||Mixed model for repeated measures|||5 min, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.107|-0.210|0.511
70877023|NCT02772081|141238437|SUPERIORITY||Adjusted mean difference|-0.05||||0.488|TWO_SIDED|95.0|-0.196|0.096|||Mixed model for repeated measures|||15 min, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.096|-0.196|0.488
70877024|NCT02772081|141238437|SUPERIORITY||Adjusted mean difference|-0.11||||0.091|TWO_SIDED|95.0|-0.239|0.019|||Mixed model for repeated measures|||30 min, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.019|-0.239|0.091
70877025|NCT02772081|141238437|SUPERIORITY||Adjusted mean difference|-0.024||||0.344|TWO_SIDED|95.0|-0.076|0.027|||Mixed model for repeated measures|||1 hour, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.027|-0.076|0.344
70877026|NCT02772081|141238437|SUPERIORITY||Adjusted mean difference|-0.026||||0.376|TWO_SIDED|95.0|-0.084|0.033|||Mixed model for repeated measures|||6 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.033|-0.084|0.376
70877027|NCT02772081|141238437|SUPERIORITY||Adjusted mean difference|-0.04||||0.396|TWO_SIDED|95.0|-0.135|0.055|||Mixed model for repeated measures|||12 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.055|-0.135|0.396
70877028|NCT02772081|141238437|SUPERIORITY||Adjusted mean difference|-0.026||||0.268|TWO_SIDED|95.0|-0.074|0.021|||Mixed model for repeated measures|||24 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.021|-0.074|0.268
70877029|NCT02772081|141238437|SUPERIORITY||Adjusted mean difference|-0.037||||0.147|TWO_SIDED|95.0|-0.089|0.014|||Mixed model for repeated measures|||48 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.014|-0.089|0.147
70877030|NCT02772081|141238437|SUPERIORITY||Adjusted mean difference|0.0||||0.994|TWO_SIDED|95.0|-0.055|0.055|||Mixed model for repeated measures|||72 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.055|-0.055|0.994
70877031|NCT02772081|141238437|SUPERIORITY||Adjusted mean difference|-0.004||||0.853|TWO_SIDED|95.0|-0.048|0.04|||Mixed model for repeated measures|||120 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.040|-0.048|0.853
70877032|NCT02772081|141238438|SUPERIORITY||Adjusted mean difference|-10.4||||0.09|TWO_SIDED|95.0|-22.6|1.7|||Mixed model for repeated measures|||T0; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||1.7|-22.6|0.090
70877033|NCT02772081|141238438|SUPERIORITY||Adjusted mean difference|-0.3||||0.917|TWO_SIDED|95.0|-6.4|5.8|||Mixed model for repeated measures|||5 min; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||5.8|-6.4|0.917
70877034|NCT02772081|141238438|SUPERIORITY||Adjusted mean difference|-1.5||||0.668|TWO_SIDED|95.0|-8.5|5.6|||Mixed model for repeated measures|||15 min; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||5.6|-8.5|0.668
70877035|NCT02772081|141238438|SUPERIORITY||Adjusted mean difference|4.0||||0.149|TWO_SIDED|95.0|-1.5|9.6|||Mixed model for repeated measures|||30 min; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||9.6|-1.5|0.149
70877036|NCT02772081|141238438|SUPERIORITY||Adjusted mean difference|1.8||||0.318|TWO_SIDED|95.0|-1.9|5.5|||Mixed model for repeated measures|||1 hour; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||5.5|-1.9|0.318
70877037|NCT02772081|141238438|SUPERIORITY||Adjusted mean difference|1.6||||0.148|TWO_SIDED|95.0|-0.6|3.7|||Wilcoxon (Mann-Whitney)|||6 hour; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||3.7|-0.6|0.148
70877038|NCT02772081|141238438|SUPERIORITY||Adjusted mean difference|3.3||||0.333|TWO_SIDED|95.0|-3.6|10.2|||Mixed model for repeated measures|||12 hours; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||10.2|-3.6|0.333
70877039|NCT02772081|141238438|SUPERIORITY||Adjusted mean difference|0.9||||0.56|TWO_SIDED|95.0|-2.2|4.0|||Mixed model for repeated measures|||24 hours; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||4.0|-2.2|0.560
70877040|NCT02772081|141238438|SUPERIORITY||Adjusted mean difference|2.0||||0.089|TWO_SIDED|95.0|-0.3|4.3|||Mixed model for repeated measures|||48 hours; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||4.3|-0.3|0.089
70877041|NCT02772081|141238438|SUPERIORITY||Adjusted mean difference|1.9||||0.115|TWO_SIDED|95.0|-0.5|4.4|||Mixed model for repeated measures|||72 hours; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||4.4|-0.5|0.115
70877042|NCT02772081|141238438|SUPERIORITY||Adjusted mean difference|1.1||||0.284|TWO_SIDED|95.0|-1.0|3.3|||Mixed model for repeated measures|||120 hours; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||3.3|-1.0|0.284
70877043|NCT02772081|141238439|SUPERIORITY||Adjusted difference|-15.7||||0.22|TWO_SIDED|95.0|-39.6|8.2|||Cochran-Mantel-Haenszel|||Any intubation procedure in first 72 hours of life.||8.2|-39.6|0.220
70877044|NCT02772081|141238439|SUPERIORITY||Adjusted difference|4.9||||0.741|TWO_SIDED|95.0|-22.8|32.5|||Cochran-Mantel-Haenszel|||Any intubation procedure within 36 weeks PMA.||32.5|-22.8|0.741
70877045|NCT02772081|141238440|SUPERIORITY||Median Difference (Final Values)|-8.0||||0.333|TWO_SIDED|95.0|-32.3|16.3|||Wilcoxon (Mann-Whitney)|||Duration of invasive MV in first 28 days PNA.||16.3|-32.3|0.333
70877046|NCT02772081|141238440|SUPERIORITY||Median Difference (Final Values)|-8.0||||0.334|TWO_SIDED|95.0|-49.5|33.5|||Wilcoxon (Mann-Whitney)|||Duration of invasive MV within 36 weeks PMA.||33.5|-49.5|0.334
70877047|NCT02772081|141238441|SUPERIORITY||Adjusted difference|-28.6||||0.596|TWO_SIDED|95.0|-120.9|63.6|||Wilcoxon (Mann-Whitney)|||Duration of invasive mechanical ventilation.||63.6|-120.9|0.596
70877048|NCT02772081|141238442|SUPERIORITY||CMH adjusted difference|-18.6||||0.219|TWO_SIDED|95.0|-47.0|9.8||The percentage of neonates needing invasive MV in the first 72 hours of life, was compared between the treatment groups using the Cochran-Mantel-Haenszel (CMH) test, adjusted for gestational age (GA) group.|Cochran-Mantel-Haenszel|||Invasive MV in the first 72 hours of life.||9.8|-47.0|0.219
70877049|NCT02772081|141238442|SUPERIORITY||Adjusted difference|-3.4||||0.826|TWO_SIDED|95.0|-33.5|26.7|||Cochran-Mantel-Haenszel|||Invasive MV in first 28 days PNA||26.7|-33.5|0.826
70877050|NCT02772081|141238442|SUPERIORITY||Adjusted difference|-3.4||||0.826|TWO_SIDED|95.0|-33.5|26.7|||Cochran-Mantel-Haenszel|||Invasive MV within 36 weeks PMA.||26.7|-33.5|0.826
70877051|NCT02451839|141238457|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||< 0.001
70877052|NCT02451839|141238458|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
70877053|NCT02451839|141238459|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
70877054|NCT02451839|141238460|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
70877055|NCT02451839|141238461|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
70877056|NCT02451839|141238462|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
70877057|NCT02451839|141238463|SUPERIORITY|||||||0.015|||||||paired t-test|||||||0.015
70877058|NCT02451839|141238464|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
70877059|NCT02451839|141238465|SUPERIORITY|||||||0.006|||||||paired t-test|||||||0.006
70877060|NCT02451839|141238466|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
70877061|NCT02451839|141238467|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
70877062|NCT02451839|141238468|SUPERIORITY|||||||0.006|||||||paired t-test|||||||0.006
70877063|NCT02451839|141238469|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
70877064|NCT02451839|141238470|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
70877065|NCT02451839|141238471|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
70877066|NCT02451839|141238472|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
70877067|NCT03103919|141238474|SUPERIORITY||Mean Difference (Final Values)|-4.31|||=|0.134|TWO_SIDED|95.0|-10.04|1.41|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||1.41|-10.04|=0.134
70877068|NCT03103919|141238475|SUPERIORITY||Mean Difference (Final Values)|0.01|||=|0.982|TWO_SIDED|95.0|-0.44|0.45|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.45|-0.44|=0.982
70877069|NCT03103919|141238476|SUPERIORITY||Mean Difference (Final Values)|-0.18|||=|0.566|TWO_SIDED|95.0|-0.81|0.45|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.45|-0.81|=0.566
70877070|NCT03103919|141238477|SUPERIORITY||Mean Difference (Final Values)|-0.07|||=|0.72|TWO_SIDED|95.0|-0.5|0.35|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.35|-0.50|=0.720
70877071|NCT03103919|141238478|SUPERIORITY||Mean Difference (Final Values)|0.15|||=|0.443|TWO_SIDED|95.0|-0.24|0.53|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.53|-0.24|=0.443
70877072|NCT03103919|141238479|SUPERIORITY||Mean Difference (Final Values)|-0.09|||=|0.777|TWO_SIDED|95.0|-0.75|0.57|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.57|-0.75|=0.777
70877073|NCT03103919|141238480|SUPERIORITY||Mean Difference (Final Values)|-0.01|||=|0.947|TWO_SIDED|95.0|-0.33|0.31|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.31|-0.33|=0.947
70877074|NCT03103919|141238481|SUPERIORITY||Mean Difference (Final Values)|-0.27|||=|0.306|TWO_SIDED|95.0|-0.79|0.26|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.26|-0.79|=0.306
70877075|NCT03103919|141238482|SUPERIORITY||Mean Difference (Final Values)|0.03|||=|0.819|TWO_SIDED|95.0|-0.25|0.31|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.31|-0.25|=0.819
70877076|NCT03103919|141238483|SUPERIORITY||Mean Difference (Final Values)|0.07|||=|0.663|TWO_SIDED|95.0|-0.26|0.41|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.||||0.41|-0.26|=0.663
70877077|NCT03103919|141238484|SUPERIORITY||Mean Difference (Final Values)|-0.2|||=|0.197|TWO_SIDED|95.0|-0.51|0.11|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.||||0.11|-0.51|=0.197
70877078|NCT03103919|141238487|SUPERIORITY||Odds Ratio (OR)|1.14|||=|0.876|TWO_SIDED|95.0|0.23|5.66||P-values for the comparison of treatment groups have been calculated using logistic regression with factors for treatment and center.|Regression, Logistic||Odds ratio was calculated as Control Group/Experimental Group (Rotigotine + Standard Care SS / Rotigotine + Standard Care + Kinesia-360™ wearable device SS) calculated using logistic regression with factors for treatment and center.|||5.66|0.23|=0.876
70877079|NCT01291173|141238489|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.014||||0.8825|TWO_SIDED|95.0|-0.203|0.175|||Mixed Models Analysis|||||0.175|-0.203|0.8825
70877080|NCT01291173|141238489|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.258||||0.0077|TWO_SIDED|95.0|-0.446|-0.069|||Mixed Models Analysis|||||-0.069|-0.446|0.0077
70877081|NCT01291173|141238489|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.345||||0.0004|TWO_SIDED|95.0|-0.534|-0.155|||Mixed Models Analysis|||||-0.155|-0.534|0.0004
70877082|NCT01291173|141238490|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4676|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.4676
70877083|NCT01291173|141238490|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0198|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0198
70877084|NCT01291173|141238490|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0031|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0031
70877085|NCT01291173|141238491|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3341|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.3341
70877086|NCT01291173|141238491|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0063|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0063
70877087|NCT01291173|141238491|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0022|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0022
70877088|NCT01291173|141238492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0937|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0937
70877089|NCT01291173|141238492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0127|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0127
70877090|NCT01291173|141238492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0009
70877091|NCT01291173|141238495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0091|TWO_SIDED|95.0|||||Chi-squared|||||||0.0091
70877092|NCT01291173|141238495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004|TWO_SIDED|95.0|||||Chi-squared|||||||0.0004
70877093|NCT01291173|141238495|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||Chi-squared|||||||<0.0001
70877094|NCT01291173|141238496|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.97||||0.0142|TWO_SIDED|95.0|-5.34|-0.6|||Mixed Models Analysis|||||-0.60|-5.34|0.0142
70877095|NCT01291173|141238496|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.25||||0.0075|TWO_SIDED|95.0|-5.62|-0.88|||Mixed Models Analysis|||||-0.88|-5.62|0.0075
70877096|NCT01291173|141238496|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.93|||<|0.0001|TWO_SIDED|95.0|-7.3|-2.56|||Mixed Models Analysis|||||-2.56|-7.30|<0.0001
70877097|NCT01291173|141238497|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15||||0.7538|TWO_SIDED|95.0|-1.11|0.8|||Mixed Models Analysis|||||0.80|-1.11|0.7538
70877098|NCT01291173|141238497|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.49||||0.3062|TWO_SIDED|95.0|-0.45|1.44|||Mixed Models Analysis|||||1.44|-0.45|0.3062
70877099|NCT01291173|141238497|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14||||0.7697|TWO_SIDED|95.0|-0.81|1.09|||Mixed Models Analysis|||||1.09|-0.81|0.7697
70877100|NCT01291173|141238498|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.53||||0.2046|TWO_SIDED|95.0|-0.29|1.35|||Mixed Models Analysis|||||1.35|-0.29|0.2046
70877101|NCT01291173|141238498|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.3348|TWO_SIDED|95.0|-0.42|1.22|||Mixed Models Analysis|||||1.22|-0.42|0.3348
70877102|NCT01291173|141238498|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.81||||0.0505|TWO_SIDED|95.0|0.0|1.63|||Mixed Models Analysis|||||1.63|-0.00|0.0505
70877103|NCT01291173|141238499|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0371|TWO_SIDED|95.0|||||Mixed Models Analysis|||Cognitive Restraint of Eating||||0.0371
70877104|NCT01291173|141238499|SUPERIORITY_OR_OTHER_LEGACY|||||||0.138|TWO_SIDED|95.0|||||Mixed Models Analysis|||Cognitive Restraint of Eating||||0.1380
70877105|NCT01291173|141238499|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0459|TWO_SIDED|95.0|||||Mixed Models Analysis|||Cognitive Restraint of Eating||||0.0459
70877106|NCT01291173|141238499|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0278|TWO_SIDED|95.0|||||Mixed Models Analysis|||Disinhibition||||0.0278
70877107|NCT01291173|141238499|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0022|TWO_SIDED|95.0|||||Mixed Models Analysis|||Disinhibition||||0.0022
70877108|NCT01291173|141238499|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||Disinhibition||||<0.0001
70877109|NCT01291173|141238499|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0149|TWO_SIDED|95.0|||||Mixed Models Analysis|||Hunger||||0.0149
70877110|NCT01291173|141238499|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009|TWO_SIDED|95.0|||||Mixed Models Analysis|||Hunger||||0.0009
70877111|NCT01291173|141238499|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||Hunger||||<0.0001
70877112|NCT01291173|141238500|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.9||||0.03|TWO_SIDED|95.0|-7.44|-0.38|||Mixed Models Analysis|||||-0.38|-7.44|0.030
70877113|NCT01291173|141238500|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.4||||0.002|TWO_SIDED|95.0|-8.95|-1.94|||Mixed Models Analysis|||||-1.94|-8.95|0.002
70877114|NCT01291173|141238500|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.5|||<|0.001|TWO_SIDED|95.0|-11.99|-4.92|||Mixed Models Analysis|||||-4.92|-11.99|<0.001
70877115|NCT01291173|141238501|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.65||||0.0824|TWO_SIDED|95.0|-5.64|0.34|||Mixed Models Analysis|||||0.34|-5.64|0.0824
70877116|NCT01291173|141238501|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.07||||0.1725|TWO_SIDED|95.0|-5.05|0.91|||Mixed Models Analysis|||||0.91|-5.05|0.1725
70877117|NCT01291173|141238501|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.71||||0.0148|TWO_SIDED|95.0|-6.69|-0.73|||Mixed Models Analysis|||||-0.73|-6.69|0.0148
70877118|NCT01291173|141238502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.25||||0.2504|TWO_SIDED|95.0|-0.89|3.38|||Mixed Models Analysis|||Aggregate Physical Score||3.38|-0.89|0.2504
70877119|NCT01291173|141238502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.09||||0.309|TWO_SIDED|95.0|-1.02|3.21|||Mixed Models Analysis|||Aggregate Physical Score||3.21|-1.02|0.3090
70877120|NCT01291173|141238502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5||||0.0216|TWO_SIDED|95.0|0.37|4.64|||Mixed Models Analysis|||Aggregate Physical Score||4.64|0.37|0.0216
70877121|NCT01291173|141238502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07||||0.9587|TWO_SIDED|95.0|-2.75|2.9|||Mixed Models Analysis|||Aggregate Mental Score||2.90|-2.75|0.9587
70877122|NCT01291173|141238502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.64||||0.653|TWO_SIDED|95.0|-2.17|3.45|||Mixed Models Analysis|||Aggregate Mental Score||3.45|-2.17|0.6530
70877123|NCT01291173|141238502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03||||0.9814|TWO_SIDED|95.0|-2.79|2.86|||Mixed Models Analysis|||Aggregate Mental Score||2.86|-2.79|0.9814
70877124|NCT05081011|141238515|OTHER|||||||0.006||||||A p-value of 0.05 would be considered statistically significant|Log Rank|||||||0.006
70877125|NCT05081011|141238516|OTHER||Mean Difference (Final Values)|32.7||||0.01|TWO_SIDED|95.0|8.0|57.4||A p-value of 0.05 would be considered statistically significant.|Welch 2-sample method|||||57.4|8.0|0.01
70877126|NCT05081011|141238517|OTHER||Mean Difference (Final Values)|-3.6||||0.03|TWO_SIDED|95.0|-6.8|-0.4||A p-value of 0.05 would be considered statistically significant.|Welch 2-sample method|||||-0.4|-6.8|0.03
70877127|NCT05081011|141238518|OTHER||Mean Difference (Final Values)|1.4||||0.06|TWO_SIDED|95.0|-0.03|2.8|||Welch 2-sample method|||||2.8|-0.03|0.06
70877128|NCT05081011|141238519|OTHER||Mean Difference (Final Values)|1.0||||0.46|TWO_SIDED|95.0|-1.6|3.5|||Welch 2-sample method|||||3.5|-1.6|0.46
70877129|NCT05081011|141238520|OTHER||Mean Difference (Final Values)|0.56||||0.005|TWO_SIDED|95.0|0.21|0.91|||2-sample test|2-sample test for equality of proportions with Yates continuity correction|Comparison of percentage (proportion) of participants achieving glycemic control.|Comparison of percentage (proportion) of participants achieving glycemic control.||0.91|0.21|0.005
70877130|NCT05081011|141238521|OTHER||Mean Difference (Final Values)|-68.9||||0.001|TWO_SIDED|95.0|-107.1|-30.1|||Welch 2-sample method|||||-30.1|-107.1|0.001
70877131|NCT01949051|141238523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35|||<|0.0001|TWO_SIDED|95.0|-1.943|-0.756|||Mixed Model ANOVA|||||-0.756|-1.943|<0.0001
70877132|NCT01949051|141238523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.118||||0.0003|TWO_SIDED|95.0|-1.712|-0.525|||Mixed Model ANOVA|||||-0.525|-1.712|0.0003
70877133|NCT01949051|141238523|NON_INFERIORITY_OR_EQUIVALENCE|Levocabastine OD would be declared as non-inferior to levocabastine BID if upper limit of 95% confidence interval of the treatment difference estimate (OD vs BD) was less than 1|Mean Difference (Final Values)|0.231|||||TWO_SIDED|95.0|-0.361|0.823||||||||0.823|-0.361|
70877134|NCT01506479|141238525|SUPERIORITY||Mean Difference (Final Values)|14.3|||<|0.0001|TWO_SIDED|95.0|12.0|16.6|||t-test, 2 sided|||||16.6|12.0|<0.0001
70877135|NCT01506479|141238526|OTHER||Mean Difference (Final Values)|2.9||||0.34|ONE_SIDED|90.0||4.6||The a priori threshold for statistical significance was 0.10|t-test, 1 sided|||The null hypothesis is that the vigorous exercise group warrants further investigation using a futility threshold of 3.5 compared to the control group (difference between the mean change in the control group and the mean change in the vigorous exercise group). The alternative hypothesis is that vigorous exercise does not warrant further investigation.||4.6||0.34
70877136|NCT01506479|141238526|OTHER||Mean Difference (Final Values)|1.2||||0.03|ONE_SIDED|90.0||2.8||The a priori threshold for statistical significance was set to 0.10. If the p-value is less than 0.10, the null hypothesis is rejected in favor of the alternative (moderate exercise does not warrant further investigation).|t-test, 1 sided||"The estimate is the difference between the control group and the moderate exercise group.~The upper bound of the confidence interval should be compared to the futility threshold of 3.5 to reject or not reject the null hypothesis."|The null hypothesis is that the moderate exercise group warrants further investigation using a futility threshold of 3.5 compared to the control group (difference in the mean change between the control group and the moderate exercise group). The alternative hypothesis is that moderate exercise does not warrant further investigation .||2.8||0.03
70877137|NCT01506479|141238527|SUPERIORITY|||||||0.1334|||||||t-test, 2 sided|||||||0.1334
70877138|NCT02611778|141238541|EQUIVALENCE|The confidence interval (CI) for treatment difference (FYB201 - Lucentis) was calculated using Least Square Means. If the 90% CI was completely contained in the interval \]-3.5;3.5\[ ETDRS letters, equivalence of FYB201 and Lucentis could be concluded.|Difference in least square means|-0.4|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|90.0|-1.6|0.9|||ANCOVA||An ANCOVA model was used for the analysis with the change in BCVA between baseline and Week 8 as the dependent variable, the baseline BCVA as covariate, and (pooled) country and treatment group as fixed effects.|The hypothesis of biosimilarity of FYB201 and Lucentis was tested with a two-sided equivalence test with an equivalence margin of 3 ETDRS letters. An ANCOVA model was used with the change in BCVA between baseline and Week 8 as the dependent variable, the baseline BCVA as covariate, and the country and the treatment group as fixed effects.||0.9|-1.6|
70877139|NCT02611778|141238542|OTHER||Difference in least square means|0.0|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|90.0|-1.6|1.5|||ANCOVA||An ANCOVA model was used for the analysis with the change in BCVA between baseline and Week 24 as the dependent variable, the baseline BCVA as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||1.5|-1.6|
70877140|NCT02611778|141238543|OTHER||Difference in least square means|-0.1|STANDARD_ERROR_OF_MEAN|1.08|||TWO_SIDED|90.0|-1.8|1.7|||ANCOVA||An ANCOVA model was used for the analysis with the change in BCVA between baseline and Week 48 as the dependent variable, the baseline BCVA as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||1.7|-1.8|
70877141|NCT02611778|141238544|OTHER||Difference in least square means|0.1|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-1.6|1.8|||ANCOVA||An ANCOVA model was used for the analysis with the change in BCVA between baseline and 12 months (average of Weeks 40, 44 and 48) as the dependent variable, the baseline BCVA as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||1.8|-1.6|
70877142|NCT02611778|141238545|OTHER||Difference in least square means|0.69|STANDARD_ERROR_OF_MEAN|11.469|||TWO_SIDED|90.0|-18.22|19.6|||ANCOVA||An ANCOVA model was used for the analysis with the change in FCP retinal thickness between baseline and Week 24 as the dependent variable, the baseline FCP retinal thickness as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||19.60|-18.22|
70877143|NCT02611778|141238546|OTHER||Difference in least square means|2.68|STANDARD_ERROR_OF_MEAN|11.632|||TWO_SIDED|90.0|-16.49|21.85|||ANCOVA||An ANCOVA model was used for the analysis with the change in FCP retinal thickness between baseline and Week 48 as the dependent variable, the baseline FCP retinal thickness as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||21.85|-16.49|
70877144|NCT02611778|141238547|OTHER||Difference in least square means|-5.91|STANDARD_ERROR_OF_MEAN|10.136|||TWO_SIDED|90.0|-22.62|10.8|||ANCOVA||An ANCOVA model was used for the analysis with the change in FCS retinal thickness between baseline and Week 24 as the dependent variable, the baseline FCS retinal thickness as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||10.80|-22.62|
70877145|NCT02611778|141238548|OTHER||Difference in least square means|3.68|STANDARD_ERROR_OF_MEAN|10.285|||TWO_SIDED|90.0|-13.28|20.63|||ANCOVA||An ANCOVA model was used for the analysis with the change in FCS retinal thickness between baseline and Week 48 as the dependent variable, the baseline FCS retinal thickness as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||20.63|-13.28|
70877146|NCT02611778|141238549|OTHER||Difference in least square means|0.07|STANDARD_ERROR_OF_MEAN|0.4709|||TWO_SIDED|90.0|-0.706|0.846|||ANCOVA||An ANCOVA model was used for the analysis with the change in total lesion area between baseline and Week 24 as the dependent variable, the baseline total lesion area as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||0.846|-0.706|
70877147|NCT02611778|141238550|OTHER||Difference in least square means|0.342|STANDARD_ERROR_OF_MEAN|0.5387|||TWO_SIDED|90.0|-0.547|1.23|||ANCOVA||An ANCOVA model was used for the analysis with the change in total lesion area between baseline and Week 48 as the dependent variable, the baseline total lesion area as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||1.230|-0.547|
70877148|NCT02611778|141238551|OTHER||Difference in least square means|0.21|STANDARD_ERROR_OF_MEAN|0.886|||TWO_SIDED|90.0|-1.25|1.67|||ANCOVA||An ANCOVA model was used for the analysis with change in NEI VFQ-25 composite score between baseline and Week 24 as dependent variable, baseline NEI VFQ-25 composite score as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||1.67|-1.25|
70877149|NCT02611778|141238552|OTHER||Difference in least square means|1.73|STANDARD_ERROR_OF_MEAN|1.027|||TWO_SIDED|90.0|0.04|3.42|||ANCOVA||An ANCOVA model was used for the analysis with change in NEI VFQ-25 composite score between baseline and Week 48 as dependent variable, baseline NEI VFQ-25 composite score as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||3.42|0.04|
70877150|NCT00530764|141238564|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.33|TWO_SIDED|95.0|0.72|2.6|||Regression, Logistic|||The proportions of responders were compared between the treatment groups using logistic regression with region and treatment groups as factors. The null hypothesis was that there was no difference between each of the Sativex treatment groups and placebo. The estimated response rates, odds ratios, 95% CIs for the odds ratios and p-values were presented.||2.60|0.72|0.33
70877151|NCT00530764|141238564|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.62|TWO_SIDED|95.0|0.46|1.76|||Regression, Logistic|||As for Sativex Low dose versus placebo||1.76|0.46|0.62
70877152|NCT00530764|141238564|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.61|TWO_SIDED|95.0|0.62|2.28|||Regression, Logistic|||As for Sativex Low dose versus placebo||2.28|0.62|0.61
70877153|NCT00530764|141238565|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-12.5||||0.0077|TWO_SIDED|95.0|-21.35|-3.33|||Wilcoxon rank sum tests|||Each of the active treatment groups were compared with placebo using pairwise Wilcoxon rank-sum tests. The Hodges-Lehmann estimates and 95% CI for the median differences were also presented.||-3.33|-21.35|0.0077
70877154|NCT00530764|141238565|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.97||||0.67|TWO_SIDED|95.0|-11.04|7.14|||Wilcoxin rank sum test|||As for Sativex low dose versus placebo||7.14|-11.04|0.67
70877155|NCT00530764|141238565|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-8.75||||0.039|TWO_SIDED|95.0|-17.14|0.0|||Wilcoxin rank sum test|||As for Sativex low dose versus placebo||0.00|-17.14|0.039
70877156|NCT00530764|141238566|SUPERIORITY_OR_OTHER||Estimated treatment effect|-0.75||||0.006|TWO_SIDED|95.0|-1.28|-0.22|||ANCOVA|||The change in mean pain NRS score (average pain) was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and region and treatment group as factors.||-0.22|-1.28|0.006
70877157|NCT00530764|141238566|SUPERIORITY_OR_OTHER||Estimated treatment effect|-0.09||||0.75|TWO_SIDED|95.0|-0.62|0.44|||ANCOVA|||As for Sativex low dose versus placebo||0.44|-0.62|0.75
70877158|NCT00530764|141238566|SUPERIORITY_OR_OTHER||Estimated treatment effect|-0.36||||0.19|TWO_SIDED|95.0|-0.89|0.18|||ANCOVA|||As for Sativex low dose versus placebo||0.18|-0.89|0.19
70877159|NCT00530764|141238567|SUPERIORITY_OR_OTHER||Estimated treatment effect|-0.73||||0.011|TWO_SIDED|95.0|-1.3|-0.17|||ANCOVA|||The change in mean pain NRS score (worst pain) was analyzed using ANCOVA with the baseline value as a covariate and region and treatment group as factors.||-0.17|-1.30|0.011
70877160|NCT00530764|141238567|SUPERIORITY_OR_OTHER||Estimated treatment effect|-0.35||||0.14|TWO_SIDED|95.0|-0.81|0.11|||ANCOVA|||As for Sativex low dose versus placebo||0.11|-0.81|0.14
70877161|NCT00530764|141238567|SUPERIORITY_OR_OTHER||Estimated Treatment Effect|-0.24||||0.4|TWO_SIDED|95.0|-0.81|0.32|||ANCOVA|||As for Sativex low dose versus placebo||0.32|-0.81|0.40
70877162|NCT00530764|141238568|SUPERIORITY_OR_OTHER||Estimated Treatment Effect|-0.88||||0.003|TWO_SIDED|95.0|-1.45|-0.31|||ANCOVA|||The change in mean sleep disturbance NRS score was analyzed using ANCOVA with the baseline value as a covariate and region and treatment group as factors.||-0.31|-1.45|0.003
70877163|NCT00530764|141238568|SUPERIORITY_OR_OTHER||Estimated Treatment Effect|-0.08||||0.78|TWO_SIDED|95.0|-0.65|0.49|||ANCOVA|||As for Sativex low dose versus placebo||0.49|-0.65|0.78
70877164|NCT00530764|141238568|SUPERIORITY_OR_OTHER||Estimated Treatment Effect|-0.33||||0.26|TWO_SIDED|95.0|-0.9|0.24|||ANCOVA|||As for Sativex low dose versus placebo.||0.24|-0.90|0.26
70877165|NCT01340898|141238581|SUPERIORITY_OR_OTHER||Percentage of subjects|100.0|||||TWO_SIDED|95.0|98.9|100.0|||||Immunogenicity was considered demonstrated if the lower limit of the two-sided exact 95% confidence interval (CI) for the percentage of subjects with rSBA titre ≥ 1:8 was greater than or equal to the pre-defined clinical limit of 80%.|Demonstration of the immunogenicity of the Nimenrix™ conjugate vaccine in terms of bactericidal antibodies to N. meningitidis serogroup A one-month post-dose 3 of Nimenrix™ vaccine at 7 months of age in healthy infants||100|98.9|
70877166|NCT01340898|141238581|SUPERIORITY_OR_OTHER||Percentage of subjects|99.7|||||TWO_SIDED|95.0|98.3|100.0|||||Immunogenicity was considered demonstrated if the lower limit of the two-sided exact 95% confidence interval (CI) for the percentage of subjects with rSBA titre ≥ 1:8 was greater than or equal to the pre-defined clinical limit of 80%.|Demonstration of the immunogenicity of the Nimenrix™ conjugate vaccine in terms of bactericidal antibodies to N. meningitidis serogroup C one-month post-dose 3 of Nimenrix™ vaccine at 7 months of age in healthy infants.||100|98.3|
70877167|NCT01340898|141238581|SUPERIORITY_OR_OTHER||Percentage of subjects|99.4|||||TWO_SIDED|95.0|97.8|99.9|||||Immunogenicity was considered demonstrated if the lower limit of the two-sided exact 95% confidence interval (CI) for the percentage of subjects with rSBA titre ≥ 1:8 was greater than or equal to the pre-defined clinical limit of 80%.|Demonstration of the immunogenicity of the Nimenrix™ conjugate vaccine in terms of bactericidal antibodies to N. meningitidis serogroup W-135 one-month post-dose 3 of Nimenrix™ vaccine at 7 months of age in healthy infants||99.9|97.8|
70877168|NCT01340898|141238581|SUPERIORITY_OR_OTHER||Percentage of subjects|99.7|||||TWO_SIDED|95.0|98.3|100.0|||||Immunogenicity was considered demonstrated if the lower limit of the two-sided exact 95% confidence interval (CI) for the percentage of subjects with rSBA titre ≥ 1:8 was greater than or equal to the pre-defined clinical limit of 80%.|Demonstration of the immunogenicity of the Nimenrix™ conjugate vaccine in terms of bactericidal antibodies to N. meningitidis serogroup Y one-month post-dose 3 of Nimenrix™ vaccine at 7 months of age in healthy infants||100|98.3|
70877169|NCT02056340|141238616|OTHER|||||||0.611||||||Threshold for significaance was p value \<0.05.|Mixed Models Analysis|||We used a linear mixed-effects model which accounted for all measurements taken and the time that those measurements were taken.||||0.611
70877170|NCT02056340|141238617|OTHER|||||||0.029||||||P value reflects baseline to 72 hours between groups. A p-value \<0.05 will be considered significant.|Mixed Models Analysis|||The primary comparison was at 72 hours for the self-reported influenza severity score.||||0.029
70877171|NCT02669433|141238637|SUPERIORITY||Mean Difference (Final Values)|-2.01||||0.158|TWO_SIDED|95.0|-4.8|0.79||The threshold for statistical significance was p=0.05|Mixed Models Analysis||Placebo - active|||0.79|-4.80|0.158
70877172|NCT02669433|141238637|SUPERIORITY||Mean Difference (Final Values)|0.74||||0.6069|TWO_SIDED|95.0|-2.08|3.55||The threshold for statistical significance was p=0.05|Mixed Models Analysis||Placebo - active|||3.55|-2.08|0.6069
70957171|NCT00092495|141418332|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
70957172|NCT00092495|141418332|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
70957173|NCT00092495|141418333|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
70957174|NCT00092495|141418333|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
70877173|NCT02669433|141238638|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.6531|TWO_SIDED|95.0|-2.55|1.6|||Mixed Models Analysis||Placebo - active|||1.60|-2.55|0.6531
70877174|NCT02669433|141238638|SUPERIORITY||Mean Difference (Final Values)|0.67||||0.5274|TWO_SIDED|95.0|-1.41|2.75||The threshold for statistical significance was p=0.05|Mixed Models Analysis||Placebo - active|||2.75|-1.41|0.5274
70877175|NCT02669433|141238639|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.3953|TWO_SIDED|95.0|-0.2|0.5||The threshold for statistical significance was p=0.05|Mixed Models Analysis||Placebo - active|||0.5|-0.2|0.3953
70877176|NCT02669433|141238639|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.7008|TWO_SIDED|95.0|-0.28|0.42||The threshold for statistical significance was p=0.05|Mixed Models Analysis||Placebo - active|||0.42|-0.28|0.7008
70877177|NCT02157298|141238658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.1053|<|0.0001|TWO_SIDED|95.0|-0.81|-0.39||Significant at alpha=0.05 (two-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Mixed Models Analysis|with fixed categorical effects of treatment, week, DPP-4, baseline eGFR, treatment-by-week interaction, continuous fixed covariate of baseline value.||H0: mean(dapa) minus mean(placebo) = 0 versus alternative HA: mean(dapa) minus mean(placebo) =/= 0||-0.39|-0.81|<0.0001
70957175|NCT00092495|141418333|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
70957176|NCT01171807|141418355|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
70957177|NCT00822172|141418380|SUPERIORITY|||||||0.076|||||||two-sample equal-variances t-test|||||||0.076
70957178|NCT00822172|141418381|SUPERIORITY|||||||0.048|||||||two-sample equal-variances t-test|||||||0.048
70957179|NCT00822172|141418382|SUPERIORITY|||||||0.65|||||||two-sample equal-variances t-test|||||||0.650
70877178|NCT02157298|141238659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.7|STANDARD_ERROR_OF_MEAN|5.301|<|0.0001|TWO_SIDED|95.0|-33.2|-12.2||Significant at alpha=0.05 (two-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Mixed Models Analysis|with fixed categorical effects of treatment, week, DPP-4, baseline eGFR, treatment-by-week interaction, continuous fixed covariate of baseline value.||H0: mean(dapa) minus mean(placebo) = 0 versus alternative HA: mean(dapa) minus mean(placebo) =/= 0||-12.2|-33.2|<0.0001
70877179|NCT02157298|141238660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.255|<|0.0001|TWO_SIDED|95.0|-1.7|-0.7||Significant at alpha=0.05 (two-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Mixed Models Analysis|with fixed categorical effects of treatment, week, DPP-4, baseline eGFR, treatment-by-week interaction, continuous fixed covariate of baseline value.||H0: mean(dapa) minus mean(placebo) = 0 versus alternative HA: mean(dapa) minus mean(placebo) =/= 0||-0.7|-1.7|<0.0001
70877180|NCT02157298|141238661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.4017||0.0743|TWO_SIDED|95.0|-1.51|0.07||Significant at alpha=0.05 (two-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Mixed Models Analysis|with fixed categorical effects of treatment, week, DPP-4, baseline eGFR, treatment-by-week interaction, continuous fixed covariate of baseline value.||H0: mean(dapa) minus mean(placebo) = 0 versus alternative HA: mean(dapa) minus mean(placebo) =/= 0||0.07|-1.51|0.0743
70877181|NCT02157298|141238662|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.4|STANDARD_ERROR_OF_MEAN|3.769||0.3727|TWO_SIDED|95.0|-4.0|10.7||Significant at alpha=0.05 (two-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Tsitatis, Davidian, Zhang \& Lu, with adjustment with adjustment for baseline value and DPP-4||H0: proportion(dapa) minus proportion(placebo) = 0 versus alternative HA: proportion(dapa) minus proportion(placebo) =/= 0||10.7|-4.0|0.3727
70877182|NCT00818662|141238681|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.8||||0.476||95.0|-3.1|1.5|||ANCOVA||Results combined from 100 imputations from estimates \& standard errors from 100 ANCOVA results for fixed effect of treatment, E4 allele of apolipoprotein E carrier status, \& continuous covariates age at baseline, baseline ADAS-Cog \& education level|||1.5|-3.1|0.476
70877183|NCT00818662|141238681|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.7||||0.53||95.0|-1.6|3.0|||ANCOVA||Results combined from 100 imputations from estimates \& standard errors from 100 ANCOVA results for fixed effect of treatment, E4 allele of apolipoprotein E carrier status, \& continuous covariates age at baseline, baseline ADAS-Cog \& education level|||3.0|-1.6|0.530
70877184|NCT00818662|141238682|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.4||||0.812||95.0|-2.9|3.7|||ANCOVA||Results combined from 100 imputations from estimates \& standard errors from 100 ANCOVA results for fixed effect of treatment, E4 allele of apolipoprotein E carrier status, \& continuous covariates age at baseline, baseline ADAS-Cog \& education level|||3.7|-2.9|0.812
70877185|NCT00818662|141238682|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.9||||0.602||95.0|-4.3|2.5|||ANCOVA||Results combined from 100 imputations from estimates \& standard errors from 100 ANCOVA results for fixed effect of treatment, E4 allele of apolipoprotein E carrier status, \& continuous covariates age at baseline, baseline ADAS-Cog \& education level|||2.5|-4.3|0.602
70877186|NCT00818662|141238683|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.7||||0.368||95.0|-2.3|0.8|||ANCOVA||Estimated within a ANCOVA model accounting for the fixed effect of treatment, E4 allele of apolipoprotein E carrier status, and for the continuous covariates age at baseline, baseline ADAS-Cog and education level (in years)|||0.8|-2.3|0.368
70877187|NCT00818662|141238683|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.8||||0.319||95.0|-0.8|2.4|||ANCOVA||Estimated within a ANCOVA model accounting for the fixed effect of treatment, E4 allele of apolipoprotein E carrier status, and for the continuous covariates age at baseline, baseline ADAS-Cog and education level (in years)|||2.4|-0.8|0.319
70877188|NCT00818662|141238684|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.3||||0.778||95.0|-1.8|2.4|||ANCOVA||Estimated within a ANCOVA model accounting for the fixed effect of treatment, E4 allele of apolipoprotein E carrier status, and for the continuous covariates age at baseline, baseline ADCS-ADL and education level (in years)|||2.4|-1.8|0.778
70877189|NCT00818662|141238684|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.2||||0.851||95.0|-2.3|1.9|||ANCOVA||Estimated within a ANCOVA model accounting for the fixed effect of treatment, E4 allele of apolipoprotein E carrier status, and for the continuous covariates age at baseline, baseline ADCS-ADL and education level (in years)|||1.9|-2.3|0.851
70877190|NCT00818662|141238685|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.1||||0.306||95.0|-0.1|0.3|||Mixed Models Analysis|||||0.3|-0.1|0.306
70877191|NCT00818662|141238685|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.3||||0.028||95.0|0.0|0.5|||Mixed Models Analysis|||||0.5|0.0|0.028
70877192|NCT00818662|141238686|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.1||||0.66||95.0|-0.3|0.2|||Mixed Models Analysis|||||0.2|-0.3|0.660
70877193|NCT00818662|141238686|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.0||||0.766||95.0|-0.2|0.3|||Mixed Models Analysis|||||0.3|-0.2|0.766
70877194|NCT00818662|141238687|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|1.9||||0.206||95.0|-1.0|4.8|||ANCOVA|||||4.8|-1.0|0.206
70877195|NCT00818662|141238687|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.4||||0.331||95.0|-4.3|1.5|||ANCOVA|||||1.5|-4.3|0.331
70877196|NCT00818662|141238688|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.7||||0.64||95.0|-2.1|3.4|||ANCOVA|||||3.4|-2.1|0.640
70877197|NCT00818662|141238688|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|2.5||||0.075||95.0|-0.3|5.3|||ANCOVA|||||5.3|-0.3|0.075
70877198|NCT00818662|141238689|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|1.1||||0.093||95.0|-0.2|2.3|||ANCOVA|||||2.3|-0.2|0.093
70877199|NCT00818662|141238689|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|1.1||||0.094||95.0|-0.2|2.3|||ANCOVA|||||2.3|-0.2|0.094
70877200|NCT00818662|141238690|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.1||||0.096||95.0|-2.3|0.2|||ANCOVA|||||0.2|-2.3|0.096
70877201|NCT00818662|141238690|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.0||||0.123||95.0|-2.2|0.3|||ANCOVA|||||0.3|-2.2|0.123
70877202|NCT00818662|141238691|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.4||||0.167||95.0|-0.2|1.0|||ANCOVA|||||1.0|-0.2|0.167
70877203|NCT00818662|141238691|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.0||||0.998||95.0|-0.6|0.6|||ANCOVA|||||0.6|-0.6|0.998
70877204|NCT00818662|141238692|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.4||||0.173||95.0|-0.2|0.9|||ANCOVA|||||0.9|-0.2|0.173
70877205|NCT00818662|141238692|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.1||||0.744||95.0|-0.4|0.6|||ANCOVA|||||0.6|-0.4|0.744
70877206|NCT00818662|141238693|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|1.5||||0.238||95.0|-1.0|4.0|||ANCOVA|||||4.0|-1.0|0.238
70877207|NCT00818662|141238693|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.1||||0.4||95.0|-3.6|1.4|||ANCOVA|||||1.4|-3.6|0.400
70877208|NCT00818662|141238694|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.6||||0.695||95.0|-3.6|2.4|||ANCOVA|||||2.4|-3.6|0.695
70877209|NCT00818662|141238694|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.3||||0.41||95.0|-4.5|1.9|||ANCOVA|||||1.9|-4.5|0.410
70877210|NCT00818662|141238695|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.0||||0.988||95.0|-1.5|1.5|||ANCOVA|||||1.5|-1.5|0.988
70877211|NCT00818662|141238695|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.4||||0.555||95.0|-1.0|1.9|||ANCOVA|||||1.9|-1.0|0.555
70877212|NCT00818662|141238696|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.5||||0.783||95.0|-12.2|9.2|||ANCOVA|||||9.2|-12.2|0.783
70877213|NCT00818662|141238696|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-2.1||||0.7||95.0|-13.1|8.8|||ANCOVA|||||8.8|-13.1|0.700
70877214|NCT00818662|141238697|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-15.2||||0.191||95.0|-38.0|7.7|||ANCOVA|||||7.7|-38.0|0.191
70877215|NCT00818662|141238697|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.6||||0.892||95.0|-25.4|22.1|||ANCOVA|||||22.1|-25.4|0.892
70877216|NCT00818662|141238698|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.1||||0.588||95.0|-0.4|0.2|||ANCOVA|||||0.2|-0.4|0.588
70877217|NCT00818662|141238698|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.2||||0.351||95.0|-0.5|0.2|||ANCOVA|||||0.2|-0.5|0.351
70877218|NCT03388294|141238716|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|7.32||||0.028|TWO_SIDED||||||Mixed Models Analysis|||||||0.028
70877219|NCT03388294|141238717|OTHER||Mean Difference (Net)|12.75|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||The focus for this analysis is change over time||||<0.001
70877220|NCT03388294|141238718|SUPERIORITY|||||||0.87|||||||Mixed Models Analysis|||||||0.87
70877221|NCT03388294|141238719|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|0.61||||0.006|TWO_SIDED||||||Mixed Models Analysis|||||||0.006
70877222|NCT03388294|141238720|SUPERIORITY|||||||0.76|||||||Mixed Models Analysis|||||||0.76
70877223|NCT03388294|141238721|OTHER|The focus for this analysis is change over time||||||0.849|||||||Mixed Models Analysis|||||||0.849
70877224|NCT03388294|141238722|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|0.2||||0.063|TWO_SIDED||||||Mixed Models Analysis|||||||0.063
70877225|NCT03388294|141238723|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|0.48|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
70877226|NCT03388294|141238727|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|-2.9||||0.036|TWO_SIDED||||||Mixed Models Analysis|||||||0.036
70877227|NCT03388294|141238728|OTHER|The focus for this analysis is change over time||||||0.0002|||||||Mixed Models Analysis|||||||0.0002
70877228|NCT03388294|141238729|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|0.36||||0.864|TWO_SIDED||||||Mixed Models Analysis|||||||0.864
70877229|NCT03388294|141238730|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|3.14||||0.12|TWO_SIDED||||||Mixed Models Analysis|||||||0.12
70877230|NCT03388294|141238731|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|0.02||||0.881|TWO_SIDED||||||Mixed Models Analysis|||||||0.881
70877231|NCT03388294|141238732|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|0.02||||0.846|TWO_SIDED||||||Mixed Models Analysis|||||||0.846
70877232|NCT01346839|141238747|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Regression, Cox|||||||<0.05
70877233|NCT00501293|141238759|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||t-test, 2 sided|t-test of MTS at baseline and 6 months||||||0.028
70877234|NCT00501293|141238759|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test of placebo at baseline and 6 months||||||<0.001
70877235|NCT00501293|141238760|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||t-test, 2 sided|t-test of MTS at baseline and 6 months||||||0.027
70877236|NCT00501293|141238760|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test of placebo at baseline and 6 months||||||<0.001
70877237|NCT00501293|141238763|SUPERIORITY_OR_OTHER|||||||0.071||95.0|||||t-test, 2 sided|t-test of MTS at baseline and 6 months||||||0.071
70877238|NCT00501293|141238763|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||t-test, 2 sided|t-test of placebo at baseline and 6 months||||||0.017
70877239|NCT01313767|141238789|NON_INFERIORITY_OR_EQUIVALENCE|90% of the power, 0.45 of non-inferiority margin|Mean Difference (Final Values)|0.17||||0.1347|TWO_SIDED|95.0|-0.05|0.4|||t-test, 2 sided|||The difference between the two groups was provided with 95% CI. If the upper limit of CI is no greater than 0.45 (non-inferiority margin), the study group was determined not inferior to the control group. Additionally, difference between groups in change from baseline to week 4 in wrist flexor MAS score was compared using two sample t-test.||0.40|-0.05|0.1347
70877240|NCT01313767|141238790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.2591|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 8 in wrist flexor MAS score was compared using two sample t-test.||||0.2591
70877241|NCT01313767|141238790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.3395|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 12 in wrist flexor MAS score was compared using two sample t-test.||||0.3395
70877242|NCT01313767|141238791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.0675|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 4 in elbow flexor MAS score was compared using two sample t-test.||||0.0675
70877243|NCT01313767|141238791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.0605|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 8 in elbow flexor MAS score was compared using two sample t-test.||||0.0605
70877244|NCT01313767|141238791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.0429|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 12 in elbow flexor MAS score was compared using two sample t-test.||||0.0429
70877245|NCT01313767|141238792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.6954|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 4 in finger flexor MAS score was compared using two sample t-test.||||0.6954
70877246|NCT01313767|141238792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.6024|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 8 in finger flexor MAS score was compared using two sample t-test.||||0.6024
70877247|NCT01313767|141238792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.9316|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 12 in finger flexor MAS score was compared using two sample t-test.||||0.9316
70877248|NCT01313767|141238793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.2284|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 4 in thumb flexor MAS score was compared using two sample t-test.||||0.2284
70877249|NCT01313767|141238793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.3221|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 8 in thumb flexor MAS score was compared using two sample t-test.||||0.3221
70877250|NCT01313767|141238793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.593|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 12 in thumb flexor MAS score was compared using two sample t-test.||||0.5930
70877251|NCT01313767|141238794|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.07||||0.1585|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 4 from baseline in wrist flexor was compared using Pearson's chi-square test.||||0.1585
70877252|NCT01313767|141238794|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0028||||0.9596|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 8 from baseline in wrist flexor was compared using Pearson's chi-square test.||||0.9596
70877253|NCT01313767|141238794|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.0304||||0.6164|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 12 from baseline in wrist flexor was compared using Pearson's chi-square test.||||0.6164
70877254|NCT01313767|141238795|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.098||||0.1802|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 4 from baseline in elbow flexor was compared using Pearson's chi-square test.||||0.1802
70877255|NCT01313767|141238795|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1164||||0.1176|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 8 from baseline in elbow flexor was compared using Pearson's chi-square test.||||0.1176
70877256|NCT01313767|141238795|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1138||||0.1252|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 12 from baseline in elbow flexor was compared using Pearson's chi-square test.||||0.1252
70877257|NCT01313767|141238796|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.098||||0.3431|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 4 from baseline in finger flexor was compared using Pearson's chi-square test.||||0.3431
70877258|NCT01313767|141238796|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1097||||0.1329|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 8 from baseline in finger flexor was compared using Pearson's chi-square test||||0.1329
70877259|NCT01313767|141238796|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0853||||0.2611|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 12 from baseline in finger flexor was compared using Pearson's chi-square test||||0.2611
70877260|NCT01313767|141238797|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.0654||||0.4623|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 4 from baseline in thumb flexor was compared using Pearson's chi-square test.||||0.4623
70877261|NCT01313767|141238797|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1194||||0.2007|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 8 from baseline in thumb flexor was compared using Pearson's chi-square test.||||0.2007
70877262|NCT01313767|141238797|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0172||||0.8553|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 12 from baseline in thumb flexor was compared using Pearson's chi-square test.||||0.8553
70877263|NCT01313767|141238798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.604|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in DAS score of hygiene was compared using wilcoxon rank sum test.||||0.6040
70877264|NCT01313767|141238798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.3233|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in DAS score of hygiene was compared using wilcoxon rank sum test.||||0.3233
70877265|NCT01313767|141238798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.4469|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in DAS score of hygiene was compared using wilcoxon rank sum test.||||0.4469
70877266|NCT01313767|141238799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.122|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in DAS score of dressing was compared using wilcoxon rank sum test.||||0.1220
70877267|NCT01313767|141238799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.1016|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in DAS score of dressing was compared using wilcoxon rank sum test.||||0.1016
70877268|NCT01313767|141238799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32||||0.2235|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in DAS score of dressing was compared using wilcoxon rank sum test.||||0.2235
70877269|NCT01313767|141238800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.503|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in DAS score of limb position was compared using wilcoxon rank sum test.||||0.5030
70877270|NCT01313767|141238800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.6934|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in DAS score of limb position was compared using wilcoxon rank sum test.||||0.6934
70877271|NCT01313767|141238800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9574|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in DAS score of limb position was compared using wilcoxon rank sum test.||||0.9574
70877272|NCT01313767|141238801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.7237|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in DAS score of pain was compared using wilcoxon rank sum test.||||0.7237
70877273|NCT01313767|141238801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.7237|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in DAS score of pain was compared using wilcoxon rank sum test.||||0.7237
70877274|NCT01313767|141238801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.4017|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in DAS score of pain was compared using wilcoxon rank sum test.||||0.4017
70877275|NCT01313767|141238802|SUPERIORITY_OR_OTHER|||||||0.2346|TWO_SIDED||||||Fisher Exact|||Difference between groups in frequency distribution of responders on the Global Assessment at week 12 was compared using Fisher's exact test.||||0.2346
70877276|NCT01313767|141238803|SUPERIORITY_OR_OTHER|||||||0.9513|TWO_SIDED||||||Fisher Exact|||Difference between groups in frequency distribution of responders on the Global Assessment at week 12 was compared using Fisher's exact test.||||0.9513
70877277|NCT01313767|141238804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.8088|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in carer burden scale of cleaning the palm was compared using wilcoxon rank sum test.||||0.8088
70877278|NCT01313767|141238804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.3702|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in carer burden scale of cleaning the palm was compared using wilcoxon rank sum test.||||0.3702
70877279|NCT01313767|141238804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.1497|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in carer burden scale of cleaning the palm was compared using wilcoxon rank sum test.||||0.1497
70877280|NCT01313767|141238805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.9634|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in carer burden scale of cutting the finger-nails was compared using wilcoxon rank sum test.||||0.9634
70877281|NCT01313767|141238805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.7302|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in carer burden scale of cutting the finger-nails was compared using wilcoxon rank sum test.||||0.7302
70877282|NCT01313767|141238805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.7715|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in carer burden scale of cutting the finger-nails was compared using wilcoxon rank sum test.||||0.7715
70877283|NCT01313767|141238806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.9362|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in carer burden scale of putting shirts on was compared using wilcoxon rank sum test.||||0.9362
70877284|NCT01313767|141238806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.7998|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in carer burden scale of putting shirts on was compared using wilcoxon rank sum test.||||0.7998
70877285|NCT01313767|141238806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.5436|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in carer burden scale of putting shirts on was compared using wilcoxon rank sum test.||||0.5436
70877286|NCT01313767|141238807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.7014|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in carer burden scale of cleaning the armpit was compared using wilcoxon rank sum test.||||0.7014
70877287|NCT01313767|141238807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.8884|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in carer burden scale of cleaning the armpit was compared using wilcoxon rank sum test.||||0.8884
70877288|NCT01313767|141238807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.284|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in carer burden scale of cleaning the armpit was compared using wilcoxon rank sum test.||||0.2840
70877289|NCT01287897|141238832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3|STANDARD_ERROR_OF_MEAN|10.5||0.3406|TWO_SIDED|90.0|-13.0|21.7||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|Generalized linear mixed model (GLMM)|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||||21.7|-13.0|0.3406
70877290|NCT01287897|141238832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.7|STANDARD_ERROR_OF_MEAN|11.0||0.0438|TWO_SIDED|90.0|0.7|36.7||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||||36.7|0.7|0.0438
70877291|NCT01287897|141238833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.2|STANDARD_ERROR_OF_MEAN|13.6||0.2258|TWO_SIDED|90.0|-12.1|32.6||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||||32.6|-12.1|0.2258
70877292|NCT01287897|141238834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|STANDARD_ERROR_OF_MEAN|10.5||0.2627|TWO_SIDED|90.0|-10.6|23.9||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||||23.9|-10.6|0.2627
70877293|NCT01287897|141238834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.8|STANDARD_ERROR_OF_MEAN|10.9||0.0425|TWO_SIDED|90.0|0.8|36.7||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||||36.7|0.8|0.0425
70877294|NCT01287897|141238835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.1|STANDARD_ERROR_OF_MEAN|13.7||0.1362|TWO_SIDED|90.0|-7.5|37.6||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||||37.6|-7.5|0.1362
70877295|NCT01287897|141238836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|STANDARD_ERROR_OF_MEAN|7.0||0.1527|TWO_SIDED|90.0|-4.3|18.6|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 10-mg arm at Week 2.||18.6|-4.3|0.1527
70877296|NCT01287897|141238836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.1|STANDARD_ERROR_OF_MEAN|9.1||0.0235|TWO_SIDED|90.0|3.1|33.2|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 10-mg arm at Week 4.||33.2|3.1|0.0235
70877297|NCT01287897|141238836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.9|STANDARD_ERROR_OF_MEAN|9.9||0.0792|TWO_SIDED|90.0|-2.3|30.2|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 10-mg arm at Week 6.||30.2|-2.3|0.0792
70877298|NCT01287897|141238836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.6|STANDARD_ERROR_OF_MEAN|11.0||0.1909||90.0|-8.4|27.6|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 10-mg arm at Week 10.||27.6|-8.4|0.1909
70877299|NCT01287897|141238836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|STANDARD_ERROR_OF_MEAN|6.8||0.1981|TWO_SIDED|90.0|-5.4|17.0|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 50-mg arm at Week 2.||17.0|-5.4|0.1981
70877300|NCT01287897|141238836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.6|STANDARD_ERROR_OF_MEAN|9.3||0.0132|TWO_SIDED|90.0|5.3|35.8|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 50-mg arm at Week 4.||35.8|5.3|0.0132
70877301|NCT01287897|141238836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.1|STANDARD_ERROR_OF_MEAN|10.1||0.0063|TWO_SIDED|90.0|8.6|41.7|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 50-mg arm at Week 6.||41.7|8.6|0.0063
70877302|NCT01287897|141238836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.7|STANDARD_ERROR_OF_MEAN|11.2||0.0138|TWO_SIDED|90.0|6.2|43.1|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 50-mg arm at Week 10.||43.1|6.2|0.0138
70877303|NCT01287897|141238837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.4|STANDARD_ERROR_OF_MEAN|10.2||0.0662|TWO_SIDED|90.0|-1.4|32.1|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 200-mg arm at Week 2.||32.1|-1.4|0.0662
70877304|NCT01287897|141238837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.5|STANDARD_ERROR_OF_MEAN|10.0||0.1708|TWO_SIDED|90.0|-6.9|25.8|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 200-mg arm at Week 4.||25.8|-6.9|0.1708
70877305|NCT01287897|141238837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.8|STANDARD_ERROR_OF_MEAN|11.1||0.2416|TWO_SIDED|90.0|-10.5|26.0|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 200-mg arm at Week 6.||26.0|-10.5|0.2416
70877306|NCT01287897|141238837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.1|STANDARD_ERROR_OF_MEAN|14.1||0.088|TWO_SIDED|90.0|-4.1|42.3|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 200-mg arm at Week 10.||42.3|-4.1|0.0880
70877307|NCT01287897|141238838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|3.2||0.261|TWO_SIDED|90.0|-3.2|7.2|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 2.||7.2|-3.2|0.2610
70877308|NCT01287897|141238838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|3.8||0.4291|TWO_SIDED|90.0|-5.6|7.0|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 4.||7.0|-5.6|0.4291
70877309|NCT01287897|141238838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|6.0||0.5791|TWO_SIDED|90.0|-11.0|8.6|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 6.||8.6|-11.0|0.5791
70877310|NCT01287897|141238838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|8.0||0.7544|TWO_SIDED|90.0|-18.8|7.7|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 8.||7.7|-18.8|0.7544
70877311|NCT01287897|141238838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8|STANDARD_ERROR_OF_MEAN|9.2||0.2308||90.0|-8.3|21.9|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 10.||21.9|-8.3|0.2308
70877312|NCT01287897|141238838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|7.1||0.5038|TWO_SIDED|90.0|-11.8|11.7|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 12.||11.7|-11.8|0.5038
70877313|NCT01287897|141238838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|4.9||0.0498|TWO_SIDED|90.0|0.0|16.0|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 2.||16.0|0.0|0.0498
70877314|NCT01287897|141238838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.3|STANDARD_ERROR_OF_MEAN|7.6||0.0155|TWO_SIDED|90.0|3.9|28.7|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 4.||28.7|3.9|0.0155
70877315|NCT01287897|141238838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.9|STANDARD_ERROR_OF_MEAN|8.5||0.0399|TWO_SIDED|90.0|0.9|28.9|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 6.||28.9|0.9|0.0399
70877316|NCT01287897|141238838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.5|STANDARD_ERROR_OF_MEAN|9.6||0.1866|TWO_SIDED|90.0|-7.2|24.3|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 8.||24.3|-7.2|0.1866
70877317|NCT01287897|141238838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.8|STANDARD_ERROR_OF_MEAN|10.3||0.0415|TWO_SIDED|90.0|0.9|34.7|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 10.||34.7|0.9|0.0415
70877318|NCT01287897|141238838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.5|STANDARD_ERROR_OF_MEAN|9.5||0.0408|TWO_SIDED|90.0|0.9|32.1|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 12.||32.1|0.9|0.0408
70877319|NCT01287897|141238839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|STANDARD_ERROR_OF_MEAN|5.3||0.1342|TWO_SIDED|90.0|-2.8|14.5|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 2.||14.5|-2.8|0.1342
70877320|NCT01287897|141238839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|4.3||0.2623|TWO_SIDED|90.0|-4.3|9.8|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 4.||9.8|-4.3|0.2623
70877321|NCT01287897|141238839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|6.3||0.3324|TWO_SIDED|90.0|-7.7|13.2|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 6.||13.2|-7.7|0.3324
70877322|NCT01287897|141238839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|7.5||0.6637|TWO_SIDED|90.0|-15.5|9.1|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 8.||9.1|-15.5|0.6637
70877323|NCT01287897|141238839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4|STANDARD_ERROR_OF_MEAN|9.0||0.2721||90.0|-9.3|20.2|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 10.||20.2|-9.3|0.2721
70877324|NCT01287897|141238839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|7.8||0.3022|TWO_SIDED|90.0|-8.8|16.9|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 12.||16.9|-8.8|0.3022
70877325|NCT01287897|141238840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3|STANDARD_ERROR_OF_MEAN|7.0||0.2687|TWO_SIDED|90.0|-7.2|15.8|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 2.||15.8|-7.2|0.2687
70877326|NCT01287897|141238840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|STANDARD_ERROR_OF_MEAN|7.4||0.246|TWO_SIDED|90.0|-7.1|17.3|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 4.||17.3|-7.1|0.2460
70957180|NCT01981473|141418387|SUPERIORITY_OR_OTHER||||||<|0.0001||||||As there was only one primary endpoint, no adjustment was made for multiple comparisons.|Fisher Exact|Logistic regression was to be used but the model was not fit as there were no antibodies in the etanercept group. Fisher's exact test was used.||This sample was to provide \>95% power to detect a difference of 12% in the proportion of participants positive for antidrug antibodies between the group of participants treated with a soluble receptor TNF inhibitor (etanercept) and the group of participants treated with mAB TNF inhibitors (adalimumab and infliximab) (5% vs 17%, respectively), using a Chi square test with continuity correction, an alpha of 0.05, and attrition rate of 15%.||||<0.0001
70957181|NCT02937454|141418404|OTHER||Annualised event rate ratio (RR)|0.79||||0.059|TWO_SIDED|95.0|0.62|1.01|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||Full Analysis Set (FAS)||1.01|0.62|0.059
70957182|NCT02937454|141418404|OTHER||Annualised event rate ratio (RR)|0.75||||0.024|TWO_SIDED|95.0|0.59|0.96|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||Covid-19 Sensitivity Analysis||0.96|0.59|0.024
70957183|NCT02937454|141418405|OTHER||Annualised event rate ratio (RR)|0.8||||0.05|TWO_SIDED|95.0|0.64|1.0|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||Full Analysis Set (FAS)||1.0|0.64|0.050
70957184|NCT02937454|141418405|OTHER||Annualised event rate ratio (RR)|0.77||||0.024|TWO_SIDED|95.0|0.62|0.97|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||COVID-19 sensitivity analyses||0.97|0.62|0.024
70957185|NCT02937454|141418406|OTHER||Annualised event rate ratio (RR)|0.74||||0.013|TWO_SIDED|95.0|0.58|0.94|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||Full Analysis Set (FAS)||0.94|0.58|0.013
70957186|NCT02937454|141418406|OTHER||Annualised event rate ratio (RR)|0.7||||0.005|TWO_SIDED|95.0|0.55|0.9|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||COVID-19 sensitivity analyses||0.90|0.55|0.005
70957187|NCT02937454|141418407|OTHER||Hazard Ratio (HR)|0.96||||0.809|TWO_SIDED|95.0|0.7|1.32|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline.||Full Analysis Set (FAS)||1.32|0.70|0.809
70957188|NCT02937454|141418407|OTHER||Hazard Ratio (HR)|0.94||||0.687|TWO_SIDED|95.0|0.68|1.29|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline||Covid-19 Sensitivity Analysis||1.29|0.68|0.687
70957189|NCT02937454|141418408|OTHER||Hazard Ratio (HR)|0.8||||0.03|TWO_SIDED|95.0|0.66|0.98|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline||Full Analysis Set (FAS)||0.98|0.66|0.030
70957190|NCT02937454|141418408|OTHER||Hazard Ratio (HR)|0.79||||0.023|TWO_SIDED|95.0|0.65|0.97|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline||Covid-19 Sensitivity Analysis||0.97|0.65|0.023
70957191|NCT02937454|141418409|OTHER||Annualised event rate ratio (RR)|0.67||||0.035|TWO_SIDED|95.0|0.47|0.97|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||Full Analysis Set (FAS)||0.97|0.47|0.035
70877327|NCT01287897|141238840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.2|STANDARD_ERROR_OF_MEAN|9.3||0.0633|TWO_SIDED|90.0|-1.1|29.5|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 6.||29.5|-1.1|0.0633
70957192|NCT02937454|141418409|OTHER||Annualised event rate ratio (RR)|0.61||||0.009|TWO_SIDED|95.0|0.42|0.88|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country||Covid-19 Sensitivity Analysis||0.88|0.42|0.009
70957193|NCT02937454|141418410|OTHER||Hazard Ratio (HR)|0.73||||0.006|TWO_SIDED|95.0|0.59|0.92|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline.||Full Analysis Set (FAS)||0.92|0.59|0.006
70957194|NCT02937454|141418411|OTHER||Hazard Ratio (HR)|0.77||||0.009|TWO_SIDED|95.0|0.63|0.94|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline.||Full Analysis Set (FAS)||0.94|0.63|0.009
70957195|NCT02937454|141418412|OTHER||Hazard Ratio (HR)|0.99||||0.944|TWO_SIDED|95.0|0.75|1.31|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline||Full Analysis Set (FAS)||1.31|0.75|0.944
70957196|NCT02937454|141418413|OTHER||Odds Ratio (OR)|1.14||||0.196|TWO_SIDED|95.0|0.93|1.39|||Generalised Estimating Equations (GEE)|The following variables are included in the GEE model: treatment, visit, baseline NYHA class, sex, age, HF aetiology, HF duration, and country||Full Analysis Set (FAS)||1.39|0.93|0.196
70957197|NCT02937454|141418414|OTHER|||||||0.208|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 6||||0.208
70957198|NCT02937454|141418414|OTHER|||||||0.408|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 24||||0.408
70957199|NCT02937454|141418414|OTHER|||||||0.999|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 52||||0.999
70957200|NCT02937454|141418415|OTHER|||||||0.227|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 2||||0.227
70957201|NCT02937454|141418415|OTHER|||||||0.018|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 4||||0.018
70957202|NCT02937454|141418415|OTHER|||||||0.005|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 6||||0.005
70957203|NCT02937454|141418415|OTHER|||||||0.006|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 12||||0.006
70957204|NCT02937454|141418415|OTHER|||||||0.028|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 24||||0.028
70957205|NCT02937454|141418415|OTHER|||||||0.136|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 36||||0.136
70957206|NCT02937454|141418415|OTHER|||||||0.329|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 52||||0.329
70877328|NCT01287897|141238840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|9.9||0.4036|TWO_SIDED|90.0|-13.8|18.6|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 8.||18.6|-13.8|0.4036
70877329|NCT01287897|141238840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|STANDARD_ERROR_OF_MEAN|10.2||0.1921||90.0|-7.9|25.6|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 10.||25.6|-7.9|0.1921
70877330|NCT01287897|141238840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.5|STANDARD_ERROR_OF_MEAN|10.3||0.1541|TWO_SIDED|90.0|-6.5|27.5|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 12.||27.5|-6.5|0.1541
70957207|NCT04601870|141418418|SUPERIORITY||Odds Ratio (OR)|1.5||||0.4137|TWO_SIDED|95.0|0.566|3.973|||Chi-squared|Chi squared equals 0.668 with 1 degrees of freedom|Odds ratio for completing counseling in $50 arm vs. $0 arm|||3.973|.566|0.4137
70877331|NCT01287897|141238840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|6.5||0.4893|TWO_SIDED|90.0|-10.5|10.9|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 2.||10.9|-10.5|0.4893
70877332|NCT01287897|141238840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.2|STANDARD_ERROR_OF_MEAN|8.6||0.0619|TWO_SIDED|90.0|-0.9|27.4|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 4.||27.4|-0.9|0.0619
70877333|NCT01287897|141238840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.7|STANDARD_ERROR_OF_MEAN|9.3||0.029|TWO_SIDED|90.0|2.3|33.1|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 6.||33.1|2.3|0.0290
70957208|NCT04601870|141418418|SUPERIORITY||Odds Ratio (OR)|1.5||||0.4137|TWO_SIDED|95.0|0.566|3.973|||Chi-squared|Chi squared equals 0.668 with 1 degrees of freedom|Odds ratio for completing counseling in $100 arm vs. $0 arm|||3.973|.566|0.4137
70957209|NCT04601870|141418418|SUPERIORITY||Odds Ratio (OR)|1.5||||0.3383|TWO_SIDED|95.0|0.653|3.446|||Chi-squared|Chi squared equals 0.917 with 1 degrees of freedom|Odds ratio for completing counseling in $50 or $100 arm vs. $0 arm|$0 vs. $50 or $100||3.446|.653|.3383
70957210|NCT04601870|141418419|SUPERIORITY||Odds Ratio (OR)|2.333||||0.265|TWO_SIDED|95.0|0.51|10.6751|||Chi-squared|Chi squared equals 1.243 with 1 degrees of freedom|Odds ratio for achieving confirmed abstinence at 6 months post-tqd in $50 arm vs. $0 arm|||10.6751|.5100|.2650
70957211|NCT04601870|141418419|SUPERIORITY||Odds Ratio (OR)|0.8333||||0.8472|TWO_SIDED|95.0|0.1301|5.3369|||Chi-squared|Chi squared equals 0.037 with 1 degrees of freedom|Odds ratio for achieving confirmed abstinence at 6 months post-tqd in $100 arm vs. $0 arm|||5.3369|.1301|.8472
70957212|NCT04601870|141418419|SUPERIORITY||Odds Ratio (OR)|1.541||||0.5478|TWO_SIDED|95.0|0.3731|6.364|||Chi-squared|Chi squared equals 0.361 with 1 degrees of freedom|Odds ratio for achieving confirmed abstinence at 6 months post-tqd in $50 or $100 arms vs. $0 arm|$0 vs. $50 or $100||6.3640|.3731|.5478
70957213|NCT04601870|141418419|SUPERIORITY||Odds Ratio (OR)|0.3571||||0.2276|TWO_SIDED|95.0|0.06355|2.007|||Chi-squared|Chi squared equals 1.456 with 1 degrees of freedom|Odds ratio for achieving confirmed abstinence at 6 months post-tqd in $100 arm vs. $50 arm|||2.0070|.06355|.2276
70957214|NCT03932812|141418428|SUPERIORITY||Mean Difference (Net)|1.128|STANDARD_ERROR_OF_MEAN|1.622||0.206|TWO_SIDED||||||Regression, Linear|We used generalized estimating equations to fit linear regression model for longitudinal data under the unstructured correlation matrix.|Estimated value: presented value is mean difference at month 6 from BL. Information from month 3 is included in the linear regression model. The reported p-value is the significance of the interaction effect between time and the intervention.|||||0.206
70957215|NCT03932812|141418429|SUPERIORITY||Mean Difference (Final Values)|2.376|STANDARD_ERROR_OF_MEAN|1.793||0.101|TWO_SIDED||||||Regression, Linear|We used generalized estimating equations to fit linear regression model for longitudinal data under the unstructured correlation matrix.|Estimated value: presented value is mean difference at month 6 from BL. Information from month 3 is included in the linear regression model. The reported p-value is the significance of the interaction effect between time and the intervention.|||||0.101
70957216|NCT03932812|141418430|SUPERIORITY||Mean Difference (Net)|-0.201|STANDARD_ERROR_OF_MEAN|1.174||0.836|TWO_SIDED||||||Regression, Linear|We used generalized estimating equations to fit linear regression model for longitudinal data under the unstructured correlation matrix.|Estimated value: presented value is mean difference at month 6 from BL. Information from month 3 is included in the linear regression model. The reported p-value is the significance of the interaction effect between time and the intervention.|||||0.836
70957217|NCT03932812|141418431|SUPERIORITY||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.414||0.567|TWO_SIDED||||||Chi-squared||Estimated value: presented value is for month 6. Since the outcome measure is count data, a log link function is used. The reported p-value is the significance of the interaction effect between time and intervention.|The outcome for this analyses is use of emergency care.||||0.567
70957218|NCT03932812|141418432|SUPERIORITY||Mean Difference (Final Values)|-0.363|STANDARD_ERROR_OF_MEAN|0.165||0.014|TWO_SIDED||||||Chi-squared||Estimated value: presented value is for month 6. Since the outcome measure is count data, a log link function is used. The reported p-value is the significance of the interaction effect between time and intervention.|||||0.014
70957219|NCT03932812|141418433|SUPERIORITY||Mean Difference (Final Values)|0.467|STANDARD_ERROR_OF_MEAN|0.301||0.01|TWO_SIDED||||||Chi-squared||Estimated value: presented value is for month 6. Since the outcome measure is count data, a log link function is used. The reported p-value is the significance of the interaction effect between time and intervention.|||||0.010
70957220|NCT03932812|141418434|SUPERIORITY||Mean Difference (Net)|2.11|STANDARD_ERROR_OF_MEAN|2.682||0.188|TWO_SIDED||||||Regression, Linear|We used generalized estimating equations to fit linear regression model for longitudinal data under the unstructured correlation matrix.|Estimated value: presented value is mean difference at month 6 from BL. Information from month 3 is included in the linear regression model. The reported p-value is the significance of the interaction effect between time and the intervention.|||||0.188
70957221|NCT02585232|141418442|SUPERIORITY|||||||0.483|||||||ANCOVA|Caregiver education, cognitive status of the person with dementia, and baseline caregiver burden scores were included in the model as covariates.||||||.483
70957222|NCT02585232|141418443|SUPERIORITY|||||||0.169|||||||ANCOVA|Caregiver education, cognitive status of the person with dementia, and baseline Dyadic Adjustment Scale scores were included as covariates.||Only caregivers that were currently or previously in a romantic relationship (e.g., spouses, partners) with the person with dementia reported on the Dyadic Adjustment Scale (i.e., N = 20, n = 9 in CC group and n = 11 in CC+C group).||||0.169
70957223|NCT02585232|141418444|SUPERIORITY|||||||0.763|||||||ANCOVA|Baseline quality of life scores, education, and cognitive status were included as covariates in the model.||||||0.763
70957224|NCT02585232|141418445|SUPERIORITY|||||||0.78|||||||ANCOVA|Baseline depression scores, cognitive status scores (i.e., MoCA), and education were included in the model as covariates.||||||0.780
70957225|NCT02257567|141418452|SUPERIORITY||Difference in Response Rates|5.82||||0.5353|TWO_SIDED|95.0|-14.53|25.38|||Cochran-Mantel-Haenszel|||||25.38|-14.53|0.5353
70957226|NCT02257567|141418452|SUPERIORITY||Difference in Response Rates (4.89|25.0||||0.0128|TWO_SIDED|95.0|4.89|42.63|||Cochran-Mantel-Haenszel|||||42.63|4.89|0.0128
70957227|NCT02257567|141418461|SUPERIORITY||Difference in Response Rates|0.69||||0.8817|TWO_SIDED|95.0|-19.68|20.86|||Cochran-Mantel-Haenszel|||||20.86|-19.68|0.8817
70877334|NCT01287897|141238840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.8|STANDARD_ERROR_OF_MEAN|10.7||0.0988|TWO_SIDED|90.0|-3.8|31.4|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 8.||31.4|-3.8|0.0988
70877335|NCT01287897|141238840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.2|STANDARD_ERROR_OF_MEAN|10.8||0.0549|TWO_SIDED|90.0|-0.5|35.0|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 10.||35.0|-0.5|0.0549
70877336|NCT01287897|141238840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.0|STANDARD_ERROR_OF_MEAN|10.5||0.092|TWO_SIDED|90.0|-3.3|31.3|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 12.||31.3|-3.3|0.0920
70957228|NCT02257567|141418461|SUPERIORITY||Difference in Response Rates|27.5||||0.0061|TWO_SIDED|95.0|7.66|44.74|||Cochran-Mantel-Haenszel|||||44.74|7.66|0.0061
70877337|NCT01287897|141238841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|6.8||0.4031|TWO_SIDED|90.0|-9.5|12.9|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 2.||12.9|-9.5|0.4031
70957229|NCT02257567|141418463|SUPERIORITY||Difference in Response Rates|-1.0||||0.9523|TWO_SIDED|95.0|-18.66|16.46|||Cochran-Mantel-Haenszel|||||16.46|-18.66|0.9523
70957230|NCT02257567|141418463|SUPERIORITY||Difference in Response Rates|30.0||||0.0036|TWO_SIDED|95.0|9.48|47.37|||Cochran-Mantel-Haenszel|||||47.37|9.48|0.0036
70877338|NCT01287897|141238841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.1|STANDARD_ERROR_OF_MEAN|9.6||0.1219|TWO_SIDED|90.0|-4.6|26.8|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 4.||26.8|-4.6|0.1219
70877339|NCT01287897|141238841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.9|STANDARD_ERROR_OF_MEAN|10.0||0.16|TWO_SIDED|90.0|-6.5|26.4|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 6.||26.4|-6.5|0.1600
70877340|NCT01287897|141238841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|10.3||0.6019|TWO_SIDED|90.0|-19.5|14.2|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 8.||14.2|-19.5|0.6019
70877341|NCT01287897|141238841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.3|STANDARD_ERROR_OF_MEAN|12.3||0.1601||90.0|-8.0|32.5|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 10.||32.5|-8.0|0.1601
70957231|NCT02257567|141418464|SUPERIORITY||Difference in Response Rates|3.75||||0.6574|TWO_SIDED|95.0|-15.14|22.11|||Cochran-Mantel-Haenszel|||||22.11|-15.14|0.6574
70877342|NCT01287897|141238841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.4|STANDARD_ERROR_OF_MEAN|11.7||0.2622|TWO_SIDED|90.0|-11.8|26.6|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 12.||26.6|-11.8|0.2622
70957232|NCT02257567|141418464|SUPERIORITY||Difference in Response Rates|25.0||||0.0128|TWO_SIDED|95.0|4.89|42.63|||Cochran-Mantel-Haenszel|||||42.63|4.89|0.0128
70957233|NCT02257567|141418467|SUPERIORITY||Difference in Response Rates|3.88||||0.6225|TWO_SIDED|95.0|-14.49|21.72|||Cochran-Mantel-Haenszel|||||21.72|-14.49|0.6225
70957234|NCT02257567|141418467|SUPERIORITY||Difference in Response Rates|30.0||||0.0032|TWO_SIDED|95.0|9.94|47.12|||Cochran-Mantel-Haenszel|||||47.12|9.94|0.0032
70877343|NCT01287897|141238842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|12.22||0.2173|TWO_SIDED|90.0|-29.8|10.6|||Linear mixed model (LMM)|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 2.||10.6|-29.8|0.2173
70877344|NCT01287897|141238842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.0|STANDARD_ERROR_OF_MEAN|12.95||0.1778|TWO_SIDED|90.0|-33.4|9.4|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 4.||9.4|-33.4|0.1778
70957235|NCT02257567|141418468|SUPERIORITY||Difference in Response Rates|-6.13||||0.4835|TWO_SIDED|95.0|-24.14|12.12|||Cochran-Mantel-Haenszel|||||12.12|-24.14|0.4835
70957236|NCT02257567|141418468|SUPERIORITY||Difference in Response Rates|25.0||||0.0096|TWO_SIDED|95.0|5.39|42.33|||Cochran-Mantel-Haenszel|||||42.33|5.39|0.0096
70957237|NCT02257567|141418469|SUPERIORITY||Difference in Response Rates|-0.5||||0.939|TWO_SIDED|95.0|-15.07|13.71|||Cochran-Mantel-Haenszel|||||13.71|-15.07|0.9390
70957238|NCT02257567|141418469|SUPERIORITY||Difference in Response Rates|37.5||||0.0006|TWO_SIDED|95.0|15.64|54.71|||Cochran-Mantel-Haenszel|||||54.71|15.64|0.0006
70957239|NCT02257567|141418470|SUPERIORITY||Difference in Response Rates|37.5||||0.0005|TWO_SIDED|95.0|15.82|54.62|||Cochran-Mantel-Haenszel|||||54.62|15.82|0.0005
70957240|NCT02257567|141418471|SUPERIORITY||Hazard Ratio (HR)|0.42||||0.0245|TWO_SIDED|95.0|0.19|0.91|||Log Rank|||||0.91|0.19|0.0245
70957241|NCT02257567|141418472|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.2451|TWO_SIDED|95.0|0.25|1.43|||Log Rank|||||1.43|0.25|0.2451
70957242|NCT02257567|141418473|SUPERIORITY||Hazard Ratio (HR)|0.33|||<|0.0001|TWO_SIDED|95.0|0.2|0.56|||Log Rank|||||0.56|0.20|<.0001
70957243|NCT02257567|141418474|SUPERIORITY||Hazard Ratio (HR)|0.39||||0.0003|TWO_SIDED|95.0|0.23|0.66|||Log Rank|||||0.66|0.23|0.0003
70957244|NCT02679573|141418534|NON_INFERIORITY|Used on a normal approximation approach (Miettinen and Nurminen's Likelihood Score Test), 860 subjects in the ITT population provided a 90% power to assess non-inferiority of delafloxacin vs. moxifloxacin based on the following assumptions: (1) a rate of ECR for moxifloxacin therapy and delafloxacin of 77% and 74%, respectively; (2) 1 sided type I error (α) of 0.025; and (3) a non-inferiority margin of 12.5%.|Difference in responder rates|-0.2|||||TWO_SIDED|95.0|-4.4|4.1|||||Difference = Difference in responder rates (Delafloxacin treatment group minus Moxifloxacin treatment group). Confidence intervals are calculated using Miettinen and Nurminen method without stratification.|"The null (H0) and alternative (Ha) hypotheses to be tested to establish the noninferiority of delafloxacin were:~H0: Pd - Pm ≤ -0.125 Ha: Pd - Pm \> -0.125 where Pd and Pm are the probabilities of the ECR for delafloxacin and moxifloxacin, respectively.~The treatment difference (delafloxacin - moxifloxacin) were presented, and the Miettinen-Nurminen test, without stratification, was used for the 2 sided 95% CI on the difference in response rate."||4.1|-4.4|
70957245|NCT02679573|141418535|NON_INFERIORITY|Used on a normal approximation approach (Miettinen and Nurminen's Likelihood Score Test), 860 subjects in the ITT population provided a 90% power to assess non-inferiority of delafloxacin vs. moxifloxacin based on the following assumptions: (1) a rate of ECR for moxifloxacin therapy and delafloxacin of 77% and 74%, respectively; (2) 1 sided type I error (α) of 0.025; and (3) a non-inferiority margin of 12.5%.|Difference in responder rates|9.7|||||TWO_SIDED|95.0|3.0|16.3||||||"The null (H0) and alternative (Ha) hypotheses to be tested to establish the noninferiority of delafloxacin were:~H0: Pd - Pm ≤ -0.125 Ha: Pd - Pm \> -0.125~where Pd and Pm are the probabilities of the ECR for delafloxacin and moxifloxacin, respectively.~The treatment difference (delafloxacin - moxifloxacin) was presented, and the Miettinen-Nurminen test without stratification was used for the 2 sided 95% CI on the difference in response rate."||16.3|3.0|
70957246|NCT02679573|141418536|NON_INFERIORITY|Used on a normal approximation approach (Miettinen and Nurminen's Likelihood Score Test), 860 subjects in the ITT population provided a 90% power to assess non-inferiority of delafloxacin vs. moxifloxacin based on the following assumptions: (1) a rate of ECR for moxifloxacin therapy and delafloxacin of 77% and 74%, respectively; (2) 1 sided type I error (α) of 0.025; and (3) a non-inferiority margin of 12.5%.|Difference in responder rates|0.8|||||TWO_SIDED|95.0|-3.3|4.8||||||"The null (H0) and alternative (Ha) hypotheses to be tested to establish the noninferiority of delafloxacin were:~H0: Pd - Pm ≤ -0.125 Ha: Pd - Pm \> -0.125~where Pd and Pm are the probabilities of the ECR for delafloxacin and moxifloxacin, respectively.~The treatment difference (delafloxacin - moxifloxacin) was presented, and the Miettinen-Nurminen test without stratification was used for the 2 sided 95% CI on the difference in response rate."||4.8|-3.3|
70957247|NCT02679573|141418537|NON_INFERIORITY|Used on a normal approximation approach (Miettinen and Nurminen's Likelihood Score Test), 860 subjects in the ITT population provided a 90% power to assess non-inferiority of delafloxacin vs. moxifloxacin based on the following assumptions: (1) a rate of ECR for moxifloxacin therapy and delafloxacin of 77% and 74%, respectively; (2) 1 sided type I error (α) of 0.025; and (3) a non-inferiority margin of 12.5%.|Difference in responder rates|0.8|||||TWO_SIDED|95.0|-3.0|4.6||||||"The null (H0) and alternative (Ha) hypotheses to be tested to establish the noninferiority of delafloxacin were:~H0: Pd - Pm ≤ -0.125 Ha: Pd - Pm \> -0.125~where Pd and Pm are the probabilities of the ECR for delafloxacin and moxifloxacin, respectively.~The treatment difference (delafloxacin - moxifloxacin) was presented, and the Miettinen-Nurminen test without stratification was used for the 2 sided 95% CI on the difference in response rate."||4.6|-3.0|
70957248|NCT02679573|141418538|NON_INFERIORITY|Used on a normal approximation approach (Miettinen and Nurminen's Likelihood Score Test), 860 subjects in the ITT population provided a 90% power to assess non-inferiority of delafloxacin vs. moxifloxacin based on the following assumptions: (1) a rate of ECR for moxifloxacin therapy and delafloxacin of 77% and 74%, respectively; (2) 1 sided type I error (α) of 0.025; and (3) a non-inferiority margin of 12.5%.|Difference in responder rates|0.5|||||TWO_SIDED|95.0|-4.8|5.9||||||"The null (H0) and alternative (Ha) hypotheses to be tested to establish the noninferiority of delafloxacin were:~H0: Pd - Pm ≤ -0.125 Ha: Pd - Pm \> -0.125~where Pd and Pm are the probabilities of the ECR for delafloxacin and moxifloxacin, respectively.~The treatment difference (delafloxacin - moxifloxacin) was presented, and the Miettinen-Nurminen test without stratification was used for the 2 sided 95% CI on the difference in response rate."||5.9|-4.8|
70957249|NCT02679573|141418539|OTHER|||||||0.5951||||||The log-rank test was used to compare the time to all-cause mortality between the 2 treatment groups.|Log Rank|||||||0.5951
70957250|NCT00324116|141418541|SUPERIORITY_OR_OTHER||percent responders|85.0||||||95.0|76.0|95.0|||||Proportion of responders estimated by Kaplan-Meier analysis. Proportion of responders along with 95% CI calculated directly from estimate of survival distribution function. Percentage denominator = total number of subjects without missing data.|||95|76|
70957251|NCT00324116|141418542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.29||||||95.0|-6.83|-1.75|||||95% CI for the change in mean value obtained from one sample t-test.|6 weeks||-1.75|-6.83|
70957252|NCT00324116|141418542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.86||||||95.0|-9.06|-2.67|||||95% CI for the change in mean value obtained from one sample t-test.|12 weeks||-2.67|-9.06|
70957253|NCT00324116|141418542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.12||||||95.0|-16.28|-5.96|||||95% CI for the change in mean value obtained from one sample t-test.|54 weeks||-5.96|-16.28|
70957254|NCT00324116|141418543|SUPERIORITY_OR_OTHER||percentage of subjects|5.0||||||95.0|1.61|11.32|||||Proportion of subjects gaining vision was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations|||11.32|1.61|
70957255|NCT00324116|141418544|SUPERIORITY_OR_OTHER||percentage of subjects|22.5||||||95.0|14.22|32.11|||||Proportion of subjects maintaining vision was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations.|||32.11|14.22|
70957256|NCT00324116|141418545|SUPERIORITY_OR_OTHER||percentage of subjects|13.75||||||95.0|7.39|22.24|||||Proportion of subjects with severe visual loss was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations.|||22.24|7.39|
70957257|NCT00324116|141418546|SUPERIORITY_OR_OTHER||percentage of subjects|25.97||||||95.0|16.28|34.81|||||Proportion of subjects progressing to \<=20/200 was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations.|||34.81|16.28|
70957258|NCT01451827|141418577|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.98||||0.0127|TWO_SIDED|95.0|0.96|1.0|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo.||1.00|0.96|0.0127
70957259|NCT01451827|141418577|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.97||||0.0108|TWO_SIDED|95.0|0.95|0.99|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo.||0.99|0.95|0.0108
70957260|NCT01451827|141418577|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.98||||0.0155|TWO_SIDED|95.0|0.96|1.0|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo.||1.00|0.96|0.0155
70957261|NCT01451827|141418577|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.99||||0.2417|TWO_SIDED|95.0|0.97|1.01|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo.||1.01|0.97|0.2417
70957262|NCT01451827|141418578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65||||0.0002|TWO_SIDED|95.0|0.31|0.99|||ANCOVA|||Urinary Frequency||0.99|0.31|0.0002
70957263|NCT01451827|141418578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|||<|0.0001|TWO_SIDED|95.0|0.4|1.08|||ANCOVA|||Urinary Frequency||1.08|0.40|< 0.0001
70957264|NCT01451827|141418578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92|||<|0.0001|TWO_SIDED|95.0|0.58|1.25|||ANCOVA|||Urinary Frequency||1.25|0.58|< 0.0001
70957265|NCT01451827|141418578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.0004|TWO_SIDED|95.0|0.3|1.01|||ANCOVA|||Urinary Urgency||1.01|0.30|0.0004
70957266|NCT01451827|141418578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65||||0.0004|TWO_SIDED|95.0|0.29|1.01|||ANCOVA|||Urinary Urgency||1.01|0.29|0.0004
70957267|NCT01451827|141418578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99|||<|0.0001|TWO_SIDED|95.0|0.63|1.34|||ANCOVA|||Urinary Urgency||1.34|0.63|< 0.0001
70957268|NCT01451827|141418578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86||||0.0002|TWO_SIDED|95.0|0.42|1.3|||ANCOVA|||Nocturia||1.30|0.42|0.0002
70957269|NCT01451827|141418578|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.07|||<|0.0001|TWO_SIDED|95.0|0.63|1.51|||ANCOVA|||Nocturia||1.51|0.63|< 0.0001
70957270|NCT01451827|141418578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.23|||<|0.0001|TWO_SIDED|95.0|0.8|1.66|||ANCOVA|||Nocturia||1.66|0.80|< 0.0001
70957271|NCT01451827|141418579|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.97||||0.0209|TWO_SIDED|95.0|0.94|0.99|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo.||0.99|0.94|0.0209
70957272|NCT01451827|141418579|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.96||||0.0287|TWO_SIDED|95.0|0.93|1.0|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo||1.00|0.93|0.0287
70957273|NCT01451827|141418579|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.96||||0.0298|TWO_SIDED|95.0|0.93|1.0|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo||1.00|0.93|0.0298
70957274|NCT01451827|141418579|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.98||||0.2306|TWO_SIDED|95.0|0.94|1.01|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo||1.01|0.94|0.2306
70957275|NCT00968227|141418580|SUPERIORITY|Paired t-test||||||0.001|||||||t-test, 2 sided|||||||0.001
70957276|NCT01856868|141418582|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0434|||||||t-test, 2 sided|||||||0.0434
70957277|NCT01856868|141418583|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0185|||||||t-test, 2 sided|||||||0.0185
70957278|NCT01856868|141418584|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0434|||||||t-test, 2 sided|||||||0.0434
70957279|NCT01856868|141418585|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0078|||||||t-test, 2 sided|||||||0.0078
70957280|NCT01856868|141418586|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0025|||||||t-test, 2 sided|||||||0.0025
70957281|NCT01856868|141418587|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0082|||||||t-test, 2 sided|||||||0.0082
70957282|NCT01856868|141418588|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.031|||||||t-test, 2 sided|||||||0.031
70957283|NCT01856868|141418589|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0238|||||||Wilcoxon (Mann-Whitney)|||||||0.0238
70957284|NCT01856868|141418590|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0321|||||||t-test, 2 sided|||||||0.0321
70957285|NCT01856868|141418591|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0182|||||||t-test, 2 sided|||||||0.0182
70957286|NCT01856868|141418592|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0371|||||||t-test, 2 sided|||||||0.0371
70957287|NCT01856868|141418593|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0257|||||||t-test, 2 sided|||||||0.0257
70957288|NCT01856868|141418596|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a mixed model regression analysis, including fixed effects for height and weight using patient identity as source of random variation. As a pilot study, these measures were not subject to a formal power analysis but will be used in future sample size calculations.|Mean Difference (Net)|-1.82|STANDARD_ERROR_OF_MEAN|2.51||0.47|TWO_SIDED||||||Mixed Models Analysis|||||||0.47
70957289|NCT01856868|141418597|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a mixed model regression analysis, including fixed effects for height, weight and knee extension strength using patient identity as source of random variation. As a pilot study, these measures were not subject to a formal power analysis but will be used in future sample size calculations.|Mean Difference (Net)|11.2|STANDARD_ERROR_OF_MEAN|16.6||0.5|TWO_SIDED||||||Mixed Models Analysis|||||||0.50
70957290|NCT01856868|141418599|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a mixed model regression analysis, including fixed effects for height, weight and knee extension strength using patient identity as source of random variation. As a pilot study, these measures were not subject to a formal power analysis but will be used in future sample size calculations.|Mean Difference (Net)|5.33|STANDARD_ERROR_OF_MEAN|3.79||0.159|TWO_SIDED||||||Mixed Models Analysis|||||||0.159
70957291|NCT00116753|141418611|SUPERIORITY_OR_OTHER||Percentage of partcipants|78.3|||||TWO_SIDED|96.5|69.0|86.0|||||Estimated value is the percentage of participants with all testosterone values from Day 28 to end of study \<=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||86|69|
70957292|NCT00116753|141418611|SUPERIORITY_OR_OTHER||Percentage of participants|79.5|||||TWO_SIDED|96.5|71.0|87.0|||||Estimated value is the percentage of participants with all testosterone values from Day 28 to end of study \<=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||87|71|
70957293|NCT00116753|141418611|SUPERIORITY_OR_OTHER||Percentage of participants|85.3|||||TWO_SIDED|96.5|77.0|91.0|||||Estimated value is the percentage of participants with all testosterone values from Day 28 to end of study \<=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||91|77|
70957294|NCT00116753|141418611|SUPERIORITY_OR_OTHER|||||||0.3022||95.0|||||Mantel Haenszel|||||||0.3022
70957295|NCT00116753|141418611|SUPERIORITY_OR_OTHER|||||||0.7797||95.0|||||Mantel Haenszel|||||||0.7797
70957296|NCT00116753|141418611|SUPERIORITY_OR_OTHER|||||||0.1557||95.0|||||Mantel Haenszel|||||||0.1557
70957297|NCT00116753|141418611|SUPERIORITY_OR_OTHER|||||||0.2208||95.0|||||Mantel Haenszel|||||||0.2208
70957298|NCT00116753|141418612|SUPERIORITY_OR_OTHER||Percentage of participants|80.7|||||TWO_SIDED|96.5|72.0|88.0|||||Estimated value is the percentage of participants with all testosterone values from after Day 28 to end of study \<=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||88|72|
70957299|NCT00116753|141418612|SUPERIORITY_OR_OTHER||Percentage of participants|80.2|||||TWO_SIDED|96.5|72.0|87.0|||||Estimated value is the percentage of participants with all testosterone values from Day 28 to end of study \<=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||87|72|
70957300|NCT00116753|141418612|SUPERIORITY_OR_OTHER||Percentage of participants|86.0|||||TWO_SIDED|96.5|78.0|92.0|||||Estimated value is the percentage of participants with all testosterone values from Day 28 to end of study \<=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||92|78|
70957301|NCT00116753|141418612|SUPERIORITY_OR_OTHER|||||||0.383||95.0|||||Mantel Haenszel|||||||0.3830
70957302|NCT00116753|141418612|SUPERIORITY_OR_OTHER|||||||0.9587||95.0|||||Mantel Haenszel|||||||0.9587
70957303|NCT00116753|141418612|SUPERIORITY_OR_OTHER|||||||0.2579||95.0|||||Mantel Haenszel|||||||0.2579
70957304|NCT00116753|141418612|SUPERIORITY_OR_OTHER|||||||0.2072||95.0|||||Mantel Haenszel|||||||0.2072
70957305|NCT00116753|141418613|SUPERIORITY_OR_OTHER||Percentage of participants|97.3|||||TWO_SIDED|95.0|93.0|99.0|||||Estimated value is the percentage of participants with testosterone \<=0.5 ng/mL at Day 28. Measure dispersion is the 95% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||99|93|
70957306|NCT00116753|141418613|SUPERIORITY_OR_OTHER||Percentage of participants|97.9|||||TWO_SIDED|95.0|94.0|100.0|||||Estimated value is the percentage of participants with testosterone \<=0.5 ng/mL at Day 28. Measure dispersion is the 95% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||100|94|
70957307|NCT00116753|141418613|SUPERIORITY_OR_OTHER||Percentage of participants|97.9|||||TWO_SIDED|95.0|94.0|100.0|||||Estimated value is the percentage of participants with testosterone \<=0.5 ng/mL at Day 28. Measure dispersion is the 95% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||100|94|
70957308|NCT01642251|141418617|SUPERIORITY||Hazard Ratio (HR)|0.34|||<|0.001|TWO_SIDED|80.0|0.22|0.51||one-sided p value|Regression, Cox|adjusted for ECOG performance status, abnormal protein in the Cox proportional hazard model||The significance test reported here was for treatment arms comparison in patients within the male/abnormal LDH stratum||0.51|0.22|<0.001
70957309|NCT01642251|141418617|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.18|TWO_SIDED|80.0|0.6|1.09||one-sided p value|Regression, Cox|adjusted for ECOG performance status, abnormal protein in the Cox proportional hazard model||The significance test reported here was for treatment arms comparison in patients not in the male/abnormal LDH stratum.||1.09|0.60|0.18
70957310|NCT01642251|141418617|SUPERIORITY|||||||0.028||||||p value for the interaction by treatment and stratification factor|Regression, Cox|||If there was a significant treatment-by-stratification factor interaction, the results would be reported separately for each stratum. Significance was defined as the p value was less than 0.05.||||0.028
70957311|NCT01642251|141418618|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.17|TWO_SIDED|80.0|0.64|1.07|||Regression, Cox|stratified on the stratification factors used for randomization||||1.07|0.64|0.17
70957312|NCT01642251|141418620|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||0.13
70957313|NCT01445301|141418621|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.0|||<|0.001|TWO_SIDED|95.0|-15.0|-7.0|||ANCOVA|||||-7.0|-15.0|<0.001
70957314|NCT01445301|141418621|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-8.2|||<|0.001|TWO_SIDED|95.0|-12.9|-3.6|||ANCOVA|||||-3.6|-12.9|<0.001
70957315|NCT01445301|141418623|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-3.0|||<|0.001|TWO_SIDED|95.0|-4.4|-1.5|||ANCOVA|||WEEK 1||-1.5|-4.4|<0.001
70957316|NCT01445301|141418623|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-1.8||||0.113|TWO_SIDED|95.0|-4.0|0.4|||ANCOVA|||WEEK 2||0.4|-4.0|0.113
70957317|NCT01445301|141418623|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-2.0||||0.084|TWO_SIDED|95.0|-4.2|0.3|||ANCOVA|||WEEK 4||0.3|-4.2|0.084
70957318|NCT01445301|141418623|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-2.7||||0.026|TWO_SIDED|95.0|-5.1|-0.3|||ANCOVA|||WEEK 8||-0.3|-5.1|0.026
70957319|NCT01445301|141418623|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-2.6||||0.03|TWO_SIDED|95.0|-5.0|-0.3|||ANCOVA|||WEEK 12||-0.3|-5.0|0.030
70957320|NCT01445301|141418623|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-3.4||||0.028|TWO_SIDED|95.0|-6.5|-0.4|||ANCOVA|||WEEK 1||-0.4|-6.5|0.028
70957321|NCT01445301|141418623|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-5.4||||0.004|TWO_SIDED|95.0|-9.1|-1.7|||ANCOVA|||WEEK 2||-1.7|-9.1|0.004
70877345|NCT01287897|141238842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.9|STANDARD_ERROR_OF_MEAN|16.37||0.1661|TWO_SIDED|90.0|-43.0|11.2|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 6.||11.2|-43.0|0.1661
70957322|NCT01445301|141418623|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Odds Ratio (OR)|-5.8||||0.003|TWO_SIDED|95.0|-9.6|-1.9|||ANCOVA|||WEEK 4||-1.9|-9.6|0.003
70957323|NCT01445301|141418623|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-5.5||||0.006|TWO_SIDED|95.0|-9.4|-1.6|||ANCOVA|||WEEK 8||-1.6|-9.4|0.006
70957324|NCT01445301|141418623|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-5.6||||0.005|TWO_SIDED|95.0|-9.5|-1.7|||ANCOVA|||WEEK 12||-1.7|-9.5|0.005
70957325|NCT01445301|141418623|SUPERIORITY||Mean Difference (Net)|-2.5|||<|0.001|TWO_SIDED|95.0|-3.9|-1.1|||ANCOVA|||WEEK 1||-1.1|-3.9|<0.001
70957326|NCT01445301|141418623|SUPERIORITY||Mean Difference (Net)|-3.2|||<|0.001|TWO_SIDED|95.0|-4.7|-1.6|||ANCOVA|||WEEK 2||-1.6|-4.7|<0.001
70957327|NCT01445301|141418623|SUPERIORITY||Mean Difference (Net)|-2.5||||0.002|TWO_SIDED|95.0|-4.1|-0.9|||ANCOVA|||WEEK 4||-0.9|-4.1|0.002
70957328|NCT01445301|141418623|SUPERIORITY||Mean Difference (Net)|-2.7||||0.003|TWO_SIDED|95.0|-4.5|-0.9|||ANCOVA|||WEEK 8||-0.9|-4.5|0.003
70957329|NCT01445301|141418623|SUPERIORITY||Mean Difference (Net)|-2.8||||0.002|TWO_SIDED|95.0|-4.6|-1.0|||ANCOVA|||WEEK 12||-1.0|-4.6|0.002
70957330|NCT01445301|141418623|SUPERIORITY||Mean Difference (Net)|-6.0|||<|0.001|TWO_SIDED|95.0|-8.8|-3.2|||ANCOVA|||WEEK 1||-3.2|-8.8|<0.001
70957331|NCT01445301|141418623|SUPERIORITY||Mean Difference (Net)|-8.1|||<|0.001|TWO_SIDED|95.0|-11.4|-4.7|||ANCOVA|||WEEK 2||-4.7|-11.4|<0.001
70957332|NCT01445301|141418623|SUPERIORITY||Mean Difference (Net)|-9.7|||<|0.001|TWO_SIDED|95.0|-13.1|-6.2|||ANCOVA|||WEEK 4||-6.2|-13.1|<0.001
70957333|NCT01445301|141418623|SUPERIORITY||Mean Difference (Net)|-8.6|||<|0.001|TWO_SIDED|95.0|-12.1|-5.1|||ANCOVA|||WEEK 8||-5.1|-12.1|<0.001
70957334|NCT01445301|141418623|SUPERIORITY||Mean Difference (Net)|-8.2|||<|0.001|TWO_SIDED|95.0|-11.6|-4.8|||ANCOVA|||WEEK 12||-4.8|-11.6|<0.001
70957335|NCT01445301|141418624|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-7.71|||<|0.001|TWO_SIDED|95.0|-11.3|-4.12|||ANCOVA|||Total Lesion Counts, WEEK 1||-4.12|-11.30|<0.001
70957336|NCT01445301|141418624|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-8.51|||<|0.001|TWO_SIDED|95.0|-13.24|-3.77|||ANCOVA|||Total Lesion Counts, WEEK 2||-3.77|-13.24|<0.001
70957337|NCT01445301|141418624|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-8.89|||<|0.001|TWO_SIDED|95.0|-13.37|-4.41|||ANCOVA|||Total Lesion Counts, WEEK 4||-4.41|-13.37|<0.001
70957338|NCT01445301|141418624|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-9.12|||<|0.001|TWO_SIDED|95.0|-13.82|-4.43|||ANCOVA|||Total Lesion Counts, WEEK 8||-4.43|-13.82|<0.001
70957339|NCT01445301|141418624|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-9.43|||<|0.001|TWO_SIDED|95.0|-14.11|-4.75|||ANCOVA|||Total Lesion Counts, WEEK 12||-4.75|-14.11|<0.001
70957340|NCT01445301|141418624|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-10.54|||<|0.001|TWO_SIDED|95.0|-15.12|-5.97|||ANCOVA|||Inflammatory Lesion Counts, WEEK 1||-5.97|-15.12|<0.001
70957341|NCT01445301|141418624|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-7.21||||0.011|TWO_SIDED|95.0|-12.73|-1.69|||ANCOVA|||Inflammatory Lesion Counts, WEEK 2||-1.69|-12.73|0.011
70957342|NCT01445301|141418624|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-7.64||||0.005|TWO_SIDED|95.0|-12.93|-2.35|||ANCOVA|||Inflammatory Lesion Counts, WEEK 4||-2.35|-12.93|0.005
70957343|NCT01445301|141418624|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-8.73||||0.002|TWO_SIDED|95.0|-14.2|-3.26|||ANCOVA|||Inflammatory Lesion Counts, WEEK 8||-3.26|-14.20|0.002
70957344|NCT01445301|141418624|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-8.2||||0.002|TWO_SIDED|95.0|-13.34|-3.06|||ANCOVA|||Inflammatory Lesion Counts, WEEK 12||-3.06|-13.34|0.002
70957345|NCT01445301|141418624|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-5.8||||0.011|TWO_SIDED|95.0|-10.29|-1.32|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 1||-1.32|-10.29|0.011
70957346|NCT01445301|141418624|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-8.3||||0.005|TWO_SIDED|95.0|-14.1|-2.5|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 2||-2.50|-14.10|0.005
70957347|NCT01445301|141418624|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-9.27|||<|0.001|TWO_SIDED|95.0|-14.72|-3.83|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 4||-3.83|-14.72|<0.001
70957348|NCT01445301|141418624|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-8.84||||0.002|TWO_SIDED|95.0|-14.28|-3.39|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 8||-3.39|-14.28|0.002
70957349|NCT01445301|141418624|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-9.68|||<|0.001|TWO_SIDED|95.0|-15.06|-4.3|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 12||-4.30|-15.06|<0.001
70957350|NCT01445301|141418624|SUPERIORITY||Mean Difference (Net)|-8.9|||<|0.001|TWO_SIDED|95.0|-12.32|-5.48|||ANCOVA|||Total Lesion Counts, WEEK 1||-5.48|-12.32|<0.001
70877346|NCT01287897|141238842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9|STANDARD_ERROR_OF_MEAN|17.66||0.1993|TWO_SIDED|90.0|-44.1|14.3|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 8.||14.3|-44.1|0.1993
70877347|NCT01287897|141238842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.2|STANDARD_ERROR_OF_MEAN|19.66||0.0632|TWO_SIDED|90.0|-62.7|2.3|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 10.||2.3|-62.7|0.0632
70957351|NCT01445301|141418624|SUPERIORITY||Mean Difference (Net)|-11.17|||<|0.001|TWO_SIDED|95.0|-15.18|-7.16|||ANCOVA|||Total Lesion Counts, WEEK 2||-7.16|-15.18|<0.001
70957352|NCT01445301|141418624|SUPERIORITY||Mean Difference (Net)|-12.12|||<|0.001|TWO_SIDED|95.0|-15.9|-8.35|||ANCOVA|||Total Lesion Counts, WEEK 4||-8.35|-15.90|<0.001
70957353|NCT01445301|141418624|SUPERIORITY||Mean Difference (Net)|-11.33|||<|0.001|TWO_SIDED|95.0|-15.37|-7.3|||ANCOVA|||Total Lesion Counts, WEEK 8||-7.30|-15.37|<0.001
70877348|NCT01287897|141238842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|STANDARD_ERROR_OF_MEAN|19.71||0.1975|TWO_SIDED|90.0|-49.4|15.8|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 12.||15.8|-49.4|0.1975
70957354|NCT01445301|141418624|SUPERIORITY||Mean Difference (Net)|-11.18|||<|0.001|TWO_SIDED|95.0|-15.11|-7.25|||ANCOVA|||Total Lesion Counts, WEEK 12||-7.25|-15.11|<0.001
70957355|NCT01445301|141418624|SUPERIORITY||Mean Difference (Net)|-8.32|||<|0.001|TWO_SIDED|95.0|-12.76|-3.88|||ANCOVA|||Inflammatory Lesion Counts, WEEK 1||-3.88|-12.76|<0.001
70957356|NCT01445301|141418624|SUPERIORITY||Mean Difference (Net)|-9.57|||<|0.001|TWO_SIDED|95.0|-13.83|-5.3|||ANCOVA|||Inflammatory Lesion Counts, WEEK 2||-5.30|-13.83|<0.001
70957357|NCT01445301|141418624|SUPERIORITY||Mean Difference (Net)|-7.83|||<|0.001|TWO_SIDED|95.0|-12.03|-3.62|||ANCOVA|||Inflammatory Lesion Counts, WEEK 4||-3.62|-12.03|<0.001
70957358|NCT01445301|141418624|SUPERIORITY||Mean Difference (Net)|-8.08|||<|0.001|TWO_SIDED|95.0|-12.63|-3.53|||ANCOVA|||Inflammatory Lesion Counts, WEEK 8||-3.53|-12.63|<0.001
70957359|NCT01445301|141418624|SUPERIORITY||Mean Difference (Net)|-8.56|||<|0.001|TWO_SIDED|95.0|-12.71|-4.41|||ANCOVA|||Inflammatory Lesion Counts, WEEK 12||-4.41|-12.71|<0.001
70957360|NCT01445301|141418624|SUPERIORITY||Mean Difference (Net)|-9.11|||<|0.001|TWO_SIDED|95.0|-13.53|-4.68|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 1||-4.68|-13.53|<0.001
70957361|NCT01445301|141418624|SUPERIORITY||Mean Difference (Net)|-11.05|||<|0.001|TWO_SIDED|95.0|-16.3|-5.8|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 2||-5.80|-16.30|<0.001
70957362|NCT01445301|141418624|SUPERIORITY||Mean Difference (Net)|-14.17|||<|0.001|TWO_SIDED|95.0|-18.97|-9.37|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 4||-9.37|-18.97|<0.001
70957363|NCT01445301|141418624|SUPERIORITY||Mean Difference (Net)|-13.04|||<|0.001|TWO_SIDED|95.0|-17.83|-8.25|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 8||-8.25|-17.83|<0.001
70957364|NCT01445301|141418624|SUPERIORITY||Mean Difference (Net)|-12.37|||<|0.001|TWO_SIDED|95.0|-17.05|-7.68|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 12||-7.68|-17.05|<0.001
70957365|NCT01445301|141418625|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
70957366|NCT01445301|141418625|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
70957367|NCT01445301|141418626|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 1||||0.470
70957368|NCT01445301|141418626|SUPERIORITY_OR_OTHER|||||||0.844||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 2||||0.844
70957369|NCT01445301|141418626|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 4||||0.022
70957370|NCT01445301|141418626|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 8||||<0.001
70957371|NCT01445301|141418626|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 12||||<0.001
70957372|NCT01445301|141418626|SUPERIORITY_OR_OTHER|||||||0.572||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 1||||0.572
70957373|NCT01445301|141418626|SUPERIORITY_OR_OTHER|||||||0.335||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 2||||0.335
70957374|NCT01445301|141418626|SUPERIORITY_OR_OTHER|||||||0.187||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 4||||0.187
70957375|NCT01445301|141418626|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 8||||<0.001
70957376|NCT01445301|141418626|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 12||||0.006
70957377|NCT01445301|141418627|SUPERIORITY_OR_OTHER|||||||0.002|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 twice daily and CLDM twice daily at Week 1||||0.002
70957378|NCT01445301|141418627|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 twice daily and CLDM twice daily at Week 2||||<0.001
70957379|NCT01445301|141418627|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 twice daily and CLDM twice daily at Week 4||||<0.001
70957380|NCT01445301|141418627|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 twice daily and CLDM twice daily at Week 8||||<0.001
70957381|NCT01445301|141418627|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 twice daily and CLDM twice daily at Week 12||||<0.001
70957382|NCT01445301|141418627|SUPERIORITY_OR_OTHER|||||||0.48|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 once daily and CLDM twice daily at Week 1||||0.480
70957383|NCT01445301|141418627|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 once daily and CLDM twice daily at Week 2||||<0.001
70957384|NCT01445301|141418627|SUPERIORITY_OR_OTHER|||||||0.009|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 once daily and CLDM twice daily at Week 4||||0.009
70957385|NCT01445301|141418627|SUPERIORITY_OR_OTHER|||||||0.008|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 once daily and CLDM twice daily at Week 8||||0.008
70957386|NCT01445301|141418627|SUPERIORITY_OR_OTHER|||||||0.065|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 once daily and CLDM twice daily at Week 12||||0.065
70957387|NCT02891837|141418648|OTHER|||||||0.493|||||||Wilcoxon (Mann-Whitney)|||||||0.4930
70957388|NCT02891837|141418650|OTHER|||||||0.1924|||||||Wilcoxon (Mann-Whitney)|||||||0.1924
70957389|NCT02891837|141418651|OTHER|||||||0.8678|||||||Wilcoxon (Mann-Whitney)|||||||0.8678
70957390|NCT02891837|141418658|OTHER|||||||0.6422|||||||Wilcoxon (Mann-Whitney)|||||||0.6422
70957391|NCT02891837|141418659|OTHER|||||||0.7572|||||||Wilcoxon (Mann-Whitney)|||||||0.7572
70957392|NCT02891837|141418661|OTHER|||||||0.3681|||||||Wilcoxon (Mann-Whitney)|||||||0.3681
70957393|NCT02891837|141418665|OTHER|"Sample size calculated with nQuery 7.0. Assumed standard deviation = 50 h, \& mean values of 44 h (placebo) \& 14 h (L-citrulline group), estimated effect size = 0.600, yielding a sample size N=92/group (two-sided Wilcoxon-rank-sum test with 0.01 significance level and 90% power). Assumptions for standard deviation \& mean based on Study CIT-002-01 results.~To allow for subjects being enrolled but not assigned to the full analysis set (FAS), an overall N=95 subjects per group were to be enrolled."|Location shift|219.0||||0.156|TWO_SIDED|95.0|-88.0|626.0||The threshold for statistical significance was p = 0.05|Wilcoxon (Mann-Whitney)||Treatment difference = L-citrulline - placebo For the mean and median values, that the estimated values are given in minutes \[min\]|H0: Composite endpoint in L-citrulline group = placebo group H1: Composite endpoint in L-citrulline group ≠ placebo group H0 tested using Wilcoxon-rank-sum test. Significance level = 1% (2-sided).||626.0|-88.0|0.1560
70957394|NCT02891837|141418665|OTHER||Location shift|813.1||||0.1627|TWO_SIDED|95.0|-335.5|1961.6||The threshold for statistical significance was 0.05.|t-test, 2 sided|The results of the T-test should be interpreted with caution since the endpoint is not normally distributed.|Treatment difference = L-citrulline - placebo. For the mean and median values, the estimated values are given in minutes|Post hoc analyses were done for US patients on mechanical ventilation for \<=48 hours. For all post hoc analyses a significance level of 5% was applied.||1961.6|-335.5|0.1627
70957395|NCT02891837|141418673|OTHER|||||||0.0326||||||The threshold for statistical significance was 0.05.|ANOVA|||"Values at 48 hours post-surgery start for all US patients on ventilation for ≤48 hours are presented.~Treatment group, baseline values and site were included as fixed factors, site\*treatment as interaction terms in this ANOVA. The normality assumption of residuals is critical for all considered timepoints. Please interpret results with caution."||||0.0326
70957396|NCT02891837|141418673|OTHER|||||||0.0026||||||The threshold for statistical significance was 0.05.|ANOVA|||"Values at 48 hours post-surgery start for ALL patients on ventilation for ≤48 hours are presented.~Treatment group, baseline values and site were included as fixed factors, site\*treatment as interaction terms in this ANOVA. The normality assumption of residuals is critical for all considered timepoints. Please interpret results with caution."||||0.0026
70957397|NCT03616977|141418697|EQUIVALENCE|Bioequivalence will be concluded if the 2-sided 90% Confidence Interval is completely contained within the interval (0.80, 1.25).|Ratio of geometric least squares means|1.01|||||TWO_SIDED|90.0|0.961|1.06||||||||1.06|0.961|
70957398|NCT01323972|141418702|OTHER||GMT ratio|1.32|||||TWO_SIDED|95.0|1.06|1.65|||||Consistency was demonstrated if one month post Dose 3, the 2-sided 95% confidence interval (CI) of the geometric mean titer (GMT) ratio between all pairs of lots were within \[0.5, 2\].|Demonstration of the lot-to-lot consistency between GSK 257049-Lot 1 and GSK 257049-Lot 2 in terms of anti-Circumsporozoite (anti-CS) immunogenicity.||1.65|1.06|
70957399|NCT01323972|141418702|OTHER||GMT ratio|1.06|||||TWO_SIDED|95.0|0.85|1.32|||||Consistency was demonstrated if one month post Dose 3, the 2-sided 95% confidence interval (CI) of the geometric mean titer (GMT) ratio between all pairs of lots were within \[0.5, 2\].|Demonstration of the lot-to-lot consistency between GSK 257049-Lot 1 and GSK 257049-Lot 3 in terms of anti-Circumsporozoite (anti-CS) immunogenicity.||1.32|0.85|
70957400|NCT01323972|141418702|OTHER||GMT ratio|0.8||||||95.0|0.64|1.0|||||Consistency was demonstrated if one month post Dose 3, the 2-sided 95% confidence interval (CI) of the geometric mean titer (GMT) ratio between all pairs of lots were within \[0.5, 2\].|Demonstration of the lot-to-lot consistency between GSK 257049-Lot 2 and GSK 257049-Lot 3 in terms of anti-Circumsporozoite (anti-CS) immunogenicity.||1|0.64|
70957401|NCT01323972|141418702|NON_INFERIORITY|Non-inferiority was demonstrated if one month post Dose 3, the upper limit (UL) of the 2-sided 95% CI of the GMT ratio of the pilot scale lot (Control Group) over the pooled commercial scale lots (Pooled Log Group) was below 2.|GMT ratio|0.95||||||95.0|0.79|1.15||||||Demonstration of non-inferiority of the commercial scale lots of GSK 257049 to the pilot scale lot in terms of anti-Circumsporozoite (anti-CS) immunogenicity.||1.15|0.79|
70957402|NCT01049217|141418716|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.191||0.709|TWO_SIDED|95.0|-0.3|0.45|||ANCOVA|||Analysis of covariance (ANCOVA) model was used with terms of treatment, pooled site, dideoxynucleoside analogue (D-drug) anti-retroviral agent (ART) use and baseline score.||0.45|-0.30|0.7090
70957403|NCT01049217|141418717|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5049|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Overall p-value was derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled site and D-drug ART use using modified ridit scores.||||0.5049
70957404|NCT01049217|141418718|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4271|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Overall p-value was derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled site and D-drug ART use using modified ridit scores.||||0.4271
70957405|NCT01049217|141418719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.095||0.2084|TWO_SIDED|95.0|-0.31|0.07|||ANCOVA|||Change at Week 1: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.07|-0.31|0.2084
70957406|NCT01049217|141418719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.126||0.1516|TWO_SIDED|95.0|-0.43|0.07|||ANCOVA|||Change at Week 2: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.07|-0.43|0.1516
70957407|NCT01049217|141418719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.142||0.0468|TWO_SIDED|95.0|-0.56|0.0|||ANCOVA|||Change at Week 3: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||-0.00|-0.56|0.0468
70877349|NCT01287897|141238842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|12.25||0.5868|TWO_SIDED|90.0|-17.6|22.9|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 2.||22.9|-17.6|0.5868
70877350|NCT01287897|141238842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.7|STANDARD_ERROR_OF_MEAN|12.93||0.0243|TWO_SIDED|90.0|-47.0|-4.3|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 4.||-4.3|-47.0|0.0243
70877351|NCT01287897|141238842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.4|STANDARD_ERROR_OF_MEAN|16.12||0.0834|TWO_SIDED|90.0|-49.0|4.3|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 6.||4.3|-49.0|0.0834
70877352|NCT01287897|141238842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.8|STANDARD_ERROR_OF_MEAN|17.43||0.0499|TWO_SIDED|90.0|-57.7|0.0|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 8.||-0.0|-57.7|0.0499
70877353|NCT01287897|141238842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.9|STANDARD_ERROR_OF_MEAN|19.45||0.0111|TWO_SIDED|90.0|-77.1|-12.7|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 10.||-12.7|-77.1|0.0111
70877354|NCT01287897|141238842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.5|STANDARD_ERROR_OF_MEAN|19.49||0.0221|TWO_SIDED|90.0|-71.7|-7.3|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 12.||-7.3|-71.7|0.0221
70877355|NCT01287897|141238843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|18.27||0.3157|TWO_SIDED|90.0|-39.0|21.4|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 2.||21.4|-39.0|0.3157
70877356|NCT01287897|141238843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|18.28||0.4171|TWO_SIDED|90.0|-34.0|26.4|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 4.||26.4|-34.0|0.4171
70877357|NCT01287897|141238843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|18.79||0.3837|TWO_SIDED|90.0|-36.6|25.5|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 6.||25.5|-36.6|0.3837
70877358|NCT01287897|141238843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|STANDARD_ERROR_OF_MEAN|19.27||0.3204|TWO_SIDED|90.0|-40.8|22.8|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 8.||22.8|-40.8|0.3204
70877359|NCT01287897|141238843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.9|STANDARD_ERROR_OF_MEAN|19.64||0.0649|TWO_SIDED|90.0|-62.3|2.6|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 10.||2.6|-62.3|0.0649
70877360|NCT01287897|141238843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.0|STANDARD_ERROR_OF_MEAN|19.87||0.0598|TWO_SIDED|90.0|-63.9|1.8|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 12.||1.8|-63.9|0.0598
70877361|NCT01969240|141238852|SUPERIORITY||Mean Difference (Final Values)|0.66|||||TWO_SIDED|95.0|0.46|0.86||||||||0.86|0.46|
70877362|NCT01969240|141238853|SUPERIORITY||||||<|0.013|||||||t-test, 2 sided|The a-priori significance level was 0.05.||||||<0.013
70877363|NCT01969240|141238854|SUPERIORITY||Mean Difference (Final Values)|10.3|||||TWO_SIDED|95.0|9.1|11.5||||||||11.5|9.1|
70877364|NCT01969240|141238855|SUPERIORITY|||||||0.998|||||||Regression, Logistic|||||||0.998
70877365|NCT01969240|141238856|SUPERIORITY||||||<|0.001|||||||negative binomial model|||||||<0.001
70877366|NCT01969240|141238857|SUPERIORITY||Mean Difference (Final Values)|-2.9|||||TWO_SIDED|95.0|-4.8|-0.9||||||||-0.90|-4.8|
70877367|NCT01969240|141238858|SUPERIORITY||Median Difference (Final Values)|1.7|||||TWO_SIDED|95.0|-0.2|3.6||||||||3.6|-0.2|
70957408|NCT01049217|141418719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.177||0.1224|TWO_SIDED|95.0|-0.62|0.07|||ANCOVA|||Change at Week 4: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.07|-0.62|0.1224
70957409|NCT01049217|141418719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.184||0.0373|TWO_SIDED|95.0|-0.75|-0.02|||ANCOVA|||Change at Week 5: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||-0.02|-0.75|0.0373
70957410|NCT01049217|141418719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.199||0.166|TWO_SIDED|95.0|-0.67|0.12|||ANCOVA|||Change at Week 6: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.12|-0.67|0.1660
70957411|NCT01049217|141418719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.214||0.3246|TWO_SIDED|95.0|-0.63|0.21|||ANCOVA|||Change at Week 7: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.21|-0.63|0.3246
70957412|NCT01049217|141418719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.219||0.4879|TWO_SIDED|95.0|-0.58|0.28|||ANCOVA|||Change at Week 8: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.28|-0.58|0.4879
70957413|NCT01049217|141418719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.223||0.2669|TWO_SIDED|95.0|-0.69|0.19|||ANCOVA|||Change at Week 9: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.19|-0.69|0.2669
70957414|NCT01049217|141418719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.219||0.5452|TWO_SIDED|95.0|-0.56|0.3|||ANCOVA|||Change at Week 10: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.30|-0.56|0.5452
70957415|NCT01049217|141418719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.229||0.5469|TWO_SIDED|95.0|-0.59|0.31|||ANCOVA|||Change at Week 11: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.31|-0.59|0.5469
70957416|NCT01049217|141418719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.24||0.7843|TWO_SIDED|95.0|-0.54|0.41|||ANCOVA|||Change at Week 12: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.41|-0.54|0.7843
70957417|NCT01049217|141418719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.24||0.9008|TWO_SIDED|95.0|-0.5|0.44|||ANCOVA|||Change at Week 13: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.44|-0.50|0.9008
70957418|NCT01049217|141418719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.24||0.9064|TWO_SIDED|95.0|-0.45|0.5|||ANCOVA|||Change at Week 14: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.50|-0.45|0.9064
70957419|NCT01049217|141418719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.243||0.7205|TWO_SIDED|95.0|-0.57|0.39|||ANCOVA|||Change at Week 15: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.39|-0.57|0.7205
70957420|NCT01049217|141418719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.259||0.4334|TWO_SIDED|95.0|-0.71|0.31|||ANCOVA|||Change at Week 16: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.31|-0.71|0.4334
70957421|NCT01049217|141418719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.199||0.8402|TWO_SIDED|95.0|-0.43|0.35|||ANCOVA|||Change at Endpoint: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.35|-0.43|0.8402
70957422|NCT01049217|141418720|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.085||0.3098|TWO_SIDED|95.0|-0.25|0.08|||ANCOVA|||Change at Week 1: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.08|-0.25|0.3098
70957423|NCT01049217|141418720|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.118||0.2429|TWO_SIDED|95.0|-0.37|0.09|||ANCOVA|||Change at Week 2: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.09|-0.37|0.2429
70957424|NCT01049217|141418720|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.137||0.0504|TWO_SIDED|95.0|-0.54|0.0|||ANCOVA|||Change at Week 3: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.00|-0.54|0.0504
70957425|NCT01049217|141418720|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.164||0.1141|TWO_SIDED|95.0|-0.58|0.06|||ANCOVA|||Change at Week 4: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.06|-0.58|0.1141
70877368|NCT00412854|141238866|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix+Hiberix Group minus Infanrix/Hib Group\] in percentage of seroprotected subjects was ≤ 10%.|Difference in seroprotection rate|0.61|||||TWO_SIDED|95.0|-1.68|3.39||||||"Difference in seroprotection rates against diphteria toxoid:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose primary vaccination course."||3.39|-1.68|
70957426|NCT01049217|141418720|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.173||0.0667|TWO_SIDED|95.0|-0.66|0.02|||ANCOVA|||Change at Week 5: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.02|-0.66|0.0667
70957427|NCT01049217|141418720|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.189||0.2104|TWO_SIDED|95.0|-0.61|0.13|||ANCOVA|||Change at Week 6: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.13|-0.61|0.2104
70957428|NCT01049217|141418720|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.197||0.483|TWO_SIDED|95.0|-0.53|0.25|||ANCOVA|||Change at Week 7: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.25|-0.53|0.4830
70957429|NCT01049217|141418720|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.203||0.5757|TWO_SIDED|95.0|-0.51|0.29|||ANCOVA|||Change at Week 8: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.29|-0.51|0.5757
70957430|NCT01049217|141418720|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.208||0.3231|TWO_SIDED|95.0|-0.62|0.2|||ANCOVA|||Change at Week 9: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.20|-0.62|0.3231
70957431|NCT01049217|141418720|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.212||0.3143|TWO_SIDED|95.0|-0.63|0.2|||ANCOVA|||Change at Week 10: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.20|-0.63|0.3143
70957432|NCT01049217|141418720|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.222||0.63|TWO_SIDED|95.0|-0.54|0.33|||ANCOVA|||Change at Week 11: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.33|-0.54|0.6300
70957433|NCT01049217|141418720|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.227||0.5752|TWO_SIDED|95.0|-0.57|0.32|||ANCOVA|||Change at Week 12: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.32|-0.57|0.5752
70957434|NCT01049217|141418720|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.219||0.8905|TWO_SIDED|95.0|-0.46|0.4|||ANCOVA|||Change at Week 13: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.40|-0.46|0.8905
70957435|NCT01049217|141418720|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.228||0.9991|TWO_SIDED|95.0|-0.45|0.45|||ANCOVA|||Change at Week 14: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.45|-0.45|0.9991
70957436|NCT01049217|141418720|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.228||0.8927|TWO_SIDED|95.0|-0.48|0.42|||ANCOVA|||Change at Week 15: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.42|-0.48|0.8927
70957437|NCT01049217|141418720|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.245||0.8067|TWO_SIDED|95.0|-0.54|0.42|||ANCOVA|||Change at Week 16: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.42|-0.54|0.8067
70957438|NCT01049217|141418720|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.19||0.9009|TWO_SIDED|95.0|-0.35|0.4|||ANCOVA|||Change at Endpoint: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.40|-0.35|0.9009
70957439|NCT01049217|141418721|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.177||0.0948|TWO_SIDED|95.0|-0.64|0.05|||ANCOVA|||Change at Week 4, PSI: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.05|-0.64|0.0948
70957440|NCT01049217|141418721|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.203||0.4167|TWO_SIDED|95.0|-0.57|0.23|||ANCOVA|||Change at Week 8, PSI: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.23|-0.57|0.4167
70957441|NCT01049217|141418721|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.226||0.8179|TWO_SIDED|95.0|-0.39|0.5|||ANCOVA|||Change at Week 12, PSI: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.50|-0.39|0.8179
70957442|NCT01049217|141418721|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.209||0.6913|TWO_SIDED|95.0|-0.33|0.5|||ANCOVA|||Change at Week 16, PSI: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.50|-0.33|0.6913
70957443|NCT01049217|141418721|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.203||0.9475|TWO_SIDED|95.0|-0.39|0.41|||ANCOVA|||Change at Endpoint, PSI: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.41|-0.39|0.9475
70957444|NCT01049217|141418721|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.204||0.7412|TWO_SIDED|95.0|-0.47|0.33|||ANCOVA|||Change at Week 4, PII: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.33|-0.47|0.7412
70957445|NCT01049217|141418721|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.213||0.9715|TWO_SIDED|95.0|-0.41|0.43|||ANCOVA|||Change at Week 8, PII: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.43|-0.41|0.9715
70957446|NCT01049217|141418721|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.218||0.8163|TWO_SIDED|95.0|-0.38|0.48|||ANCOVA|||Change at Week 12, PII: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.48|-0.38|0.8163
70957447|NCT01049217|141418721|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.204||0.3682|TWO_SIDED|95.0|-0.22|0.58|||ANCOVA|||Change at Week 16, PII: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.58|-0.22|0.3682
70957448|NCT01049217|141418721|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.199||0.3511|TWO_SIDED|95.0|-0.21|0.58|||ANCOVA|||Change at Endpoint, PII: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.58|-0.21|0.3511
70957449|NCT01049217|141418722|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.9686|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Burning: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.5|-0.5|0.9686
70957450|NCT01049217|141418722|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.23||0.4476|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||Change at Endpoint, Squeezing: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.3|-0.6|0.4476
70957451|NCT01049217|141418722|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.563|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||Change at Endpoint, Pressure: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.3|-0.6|0.5630
70957452|NCT01049217|141418722|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.9937|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Electric Shocks: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.5|-0.5|0.9937
70877369|NCT00412854|141238866|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix+Hiberix Group minus Infanrix/Hib Group\] in percentage of seroprotected subjects was ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.29|2.3||||||"Difference in seroprotection rates against tetanus toxoid:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course."||2.30|-2.29|
70877370|NCT00412854|141238867|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix+Hiberix Group minus Infanrix/Hib Group\] in percentage of seroprotected subjects was ≤ 10%.|Difference in seroprotection rate|2.47|||||TWO_SIDED|95.0|0.15|6.18||||||"Difference in seroprotection rates against PRP:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course."||6.18|0.15|
70877371|NCT00412854|141238868|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix+Hiberix Group minus Infanrix/Hib Group\] in percentage of subjects with a vaccine response was ≤ 10%.|Difference in seroresponse rate|0.0|||||TWO_SIDED|95.0|-2.29|2.3||||||"Difference in vaccine response rates against PT:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course."||2.30|-2.29|
70877372|NCT00412854|141238868|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix+Hiberix Group minus Infanrix/Hib Group\] in percentage of subjects with a vaccine response was ≤ 10%.|Difference in seroresponse rate|0.0|||||TWO_SIDED|95.0|-2.29|2.3||||||"Difference in vaccine response rates against FHA:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course."||2.30|-2.29|
70877373|NCT00412854|141238868|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix+Hiberix Group minus Infanrix/Hib Group\] in percentage of subjects with a vaccine response was ≤ 10%.|Difference in seroresponse rate|1.23|||||TWO_SIDED|95.0|-2.17|5.07||||||"Difference in vaccine response rates against PRN:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course."||5.07|-2.17|
70877374|NCT04483011|141238881|SUPERIORITY||Mean Difference (Net)|2.12|STANDARD_DEVIATION|4.72||0.034|TWO_SIDED|||||\< 0.05|Wilcoxon (Mann-Whitney)||The p value in RiaGev group at Day 5 over Dave 1 is reported.|A comparison between before and after RiaGev supplementation.||||0.034
70877375|NCT04483011|141238881|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|2.79||0.265|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 5 over Day 1 is reported.|A comparison between before and after supplementation of Comparator.||||0.265
70877376|NCT04483011|141238881|SUPERIORITY||Mean Difference (Net)|2.12|STANDARD_DEVIATION|4.72||0.044|TWO_SIDED|||||\< 0.05|ANCOVA||The p value between RiaGev and Comparator groups at Day 5 over Day 1 is reported.|A comparison between RiaGev and Comparator groups.||||0.044
70877377|NCT04483011|141238882|SUPERIORITY||Mean Difference (Net)|1.33|STANDARD_DEVIATION|1.88||0.008|TWO_SIDED|||||p \< 0.05|Wilcoxon (Mann-Whitney)||The p value in RiaGev group at Day 5 over Day 1 is reported.|A comparison between before and after supplementation of RiaGev.||||0.008
70957453|NCT01049217|141418722|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.8718|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Stabbing: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.5|-0.5|0.8718
70957454|NCT01049217|141418722|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.8241|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|||Change at Endpoint, Light Touching: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.4|-0.5|0.8241
70957455|NCT01049217|141418722|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.25||0.3164|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||Change at Endpoint, Pressure of Area: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.2|-0.7|0.3164
70957456|NCT01049217|141418722|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.8996|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Cold of Area: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.5|-0.5|0.8996
70957457|NCT01049217|141418722|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.9676|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Pins and Needles: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.5|-0.5|0.9676
70957458|NCT01049217|141418722|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.9091|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Tingling: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.5|-0.5|0.9091
70957459|NCT01049217|141418723|SUPERIORITY_OR_OTHER_LEGACY|||||||0.73|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Duration of Spontaneous Pain: Overall p-value was derived from CMH test adjusted for pooled site and D-drug ART use using modified ridit scores.||||0.7300
70957460|NCT01049217|141418723|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0559|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Number of Pain Attacks: Overall p-value was derived from CMH test adjusted for pooled site and D-drug ART use using modified ridit scores.||||0.0559
70957461|NCT01049217|141418724|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.025||0.9686|TWO_SIDED|95.0|-0.05|0.05|||ANCOVA|||Change at Endpoint, Burning Pain: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.05|-0.05|0.9686
70877378|NCT04483011|141238882|SUPERIORITY||Mean Difference (Net)|0.34|STANDARD_DEVIATION|1.34||0.297|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 5 over Day 1 is reported.|A comparison between before and after supplementation with Comparator.||||0.297
70957462|NCT01049217|141418724|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.022||0.4711|TWO_SIDED|95.0|-0.06|0.03|||ANCOVA|||Change at Endpoint, Pressing Pain: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.03|-0.06|0.4711
70957463|NCT01049217|141418724|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.023||0.9215|TWO_SIDED|95.0|-0.04|0.05|||ANCOVA|||Change at Endpoint, Paroxysmal Pain: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.05|-0.04|0.9215
70957464|NCT01049217|141418724|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.021||0.6042|TWO_SIDED|95.0|-0.05|0.03|||ANCOVA|||Change at Endpoint, Evoked Pain: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.03|-0.05|0.6042
70957465|NCT01049217|141418724|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.024||0.9394|TWO_SIDED|95.0|-0.05|0.04|||ANCOVA|||Change at Endpoint, P/D: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.04|-0.05|0.9394
70957466|NCT01049217|141418724|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.7801|TWO_SIDED|95.0|-0.04|0.03|||ANCOVA|||Change at Endpoint, Total Score: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.03|-0.04|0.7801
70957467|NCT01049217|141418725|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.44|STANDARD_ERROR_OF_MEAN|6.58||0.6012|TWO_SIDED||||||ANCOVA|||Endpoint TST: ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.||||0.6012
70957468|NCT01049217|141418725|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.66|STANDARD_ERROR_OF_MEAN|1.89||0.0534|TWO_SIDED||||||ANCOVA|||Endpoint MIS: ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.||||0.0534
70957469|NCT01049217|141418726|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.62||0.0966|TWO_SIDED||||||ANCOVA|||ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.||||0.0966
70957470|NCT01049217|141418727|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.97|STANDARD_ERROR_OF_MEAN|0.51||0.0611|TWO_SIDED||||||ANCOVA|||ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.||||0.0611
70957471|NCT01049217|141418728|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-8436.0|STANDARD_ERROR_OF_MEAN|6855.2||0.2195|TWO_SIDED||||||ANCOVA|||ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.||||0.2195
70957472|NCT01049217|141418729|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.|LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.66||0.8241|TWO_SIDED||||||ANCOVA|||||||0.8241
70957473|NCT01049217|141418730|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|2.052||0.8528|TWO_SIDED|95.0|-4.42|3.66|||ANCOVA|||Change at Endpoint, Sleep Disturbance: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||3.66|-4.42|0.8528
70957474|NCT01049217|141418730|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.88|STANDARD_ERROR_OF_MEAN|3.179||0.365|TWO_SIDED|95.0|-3.37|9.14|||ANCOVA|||Change at Endpoint, Snoring: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||9.14|-3.37|0.3650
70957475|NCT01049217|141418730|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.89|STANDARD_ERROR_OF_MEAN|2.525||0.7237|TWO_SIDED|95.0|-4.07|5.86|||ANCOVA|||Change at Endpoint, SOB: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||5.86|-4.07|0.7237
70957476|NCT01049217|141418730|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.165||0.2783|TWO_SIDED|95.0|-0.5|0.15|||ANCOVA|||Change at Endpoint, Quantity: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.15|-0.50|0.2783
70957477|NCT01049217|141418730|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.02|STANDARD_ERROR_OF_MEAN|2.611||0.2475|TWO_SIDED|95.0|-2.11|8.16|||ANCOVA|||Change at Endpoint, Adequacy: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||8.16|-2.11|0.2475
70957478|NCT01049217|141418730|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.16|STANDARD_ERROR_OF_MEAN|1.933||0.5492|TWO_SIDED|95.0|-2.64|4.96|||ANCOVA|||Change at Endpoint, Somnolence: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||4.96|-2.64|0.5492
70957479|NCT01049217|141418730|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|1.614||0.9113|TWO_SIDED|95.0|-3.0|3.36|||ANCOVA|||Change at Endpoint, Sleep Problems Index: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||3.36|-3.00|0.9113
70957480|NCT01049217|141418731|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7399|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Endpoint: Overall p-value was derived from CMH test adjusted for pooled site and D-drug ART use using modified ridit scores.||||0.7399
70957481|NCT01049217|141418732|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.386||0.8258|TWO_SIDED|95.0|-0.67|0.84|||ANCOVA|||Change at Endpoint, HADS-A: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.84|-0.67|0.8258
70957482|NCT01049217|141418732|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.65|STANDARD_ERROR_OF_MEAN|0.372||0.084|TWO_SIDED|95.0|-0.09|1.38|||ANCOVA|||Change at Endpoint, HADS-D: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||1.38|-0.09|0.0840
70957483|NCT01049217|141418733|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.22|STANDARD_ERROR_OF_MEAN|2.393||0.6114|TWO_SIDED|95.0|-3.49|5.92|||ANCOVA|||Change at Endpoint, Ph Fn: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||5.92|-3.49|0.6114
70957484|NCT01049217|141418733|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.57|STANDARD_ERROR_OF_MEAN|2.522||0.8209|TWO_SIDED|95.0|-4.39|5.53|||ANCOVA|||Change at Endpoint, R-P: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||5.53|-4.39|0.8209
70957485|NCT01049217|141418733|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|2.335||0.9737|TWO_SIDED|95.0|-4.52|4.67|||ANCOVA|||Change at Endpoint, BP: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||4.67|-4.52|0.9737
70957486|NCT01049217|141418733|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.76|STANDARD_ERROR_OF_MEAN|1.937||0.6966|TWO_SIDED|95.0|-3.05|4.57|||ANCOVA|||Change at Endpoint, GH: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||4.57|-3.05|0.6966
70957487|NCT01049217|141418733|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.807||0.8569|TWO_SIDED|95.0|-1.44|1.73|||ANCOVA|||Change at Endpoint, Ph C: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||1.73|-1.44|0.8569
70957488|NCT01049217|141418733|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|1.847||0.4734|TWO_SIDED|95.0|-4.96|2.31|||ANCOVA|||Change at Endpoint, Vit: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||2.31|-4.96|0.4734
70957489|NCT01049217|141418733|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.97|STANDARD_ERROR_OF_MEAN|2.159||0.3625|TWO_SIDED|95.0|-6.22|2.28|||ANCOVA|||Change at Endpoint, So Fn: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||2.28|-6.22|0.3625
70957490|NCT01049217|141418733|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.79|STANDARD_ERROR_OF_MEAN|2.543||0.2736|TWO_SIDED|95.0|-2.21|7.79|||ANCOVA|||Change at Endpoint, R-E: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||7.79|-2.21|0.2736
70957491|NCT01049217|141418733|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|1.811||0.8199|TWO_SIDED|95.0|-3.98|3.15|||ANCOVA|||Change at Endpoint, MnH: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||3.15|-3.98|0.8199
70957492|NCT01049217|141418733|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.967||0.9361|TWO_SIDED|95.0|-1.82|1.98|||ANCOVA|||Change at Endpoint, Mn C: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||1.98|-1.82|0.9361
70957493|NCT00903682|141418749|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||The hypothesis is that the proportion of patients with at least 1 treatment-emergent Grade 1-4 neuropsychiatric adverse event, observed between Baseline through Week 12 and judged to be at least possibly drug-related, is significantly lower in the ETR arm than in the EFV arm. Assuming a significance level of 5%, a sample size of 75 subjects per arm would provide over 90% power to detect a 29% difference in treatment-emergent, drug-related Grade 1-4 neuropsychiatric adverse events.||||<0.001
70957494|NCT00903682|141418750|SUPERIORITY_OR_OTHER||Difference in proportion of response|1.61|||||TWO_SIDED|95.0|-12.0|15.23|||||Difference in proportion of response ETR minus EFV|||15.23|-12.00|
70877379|NCT04483011|141238882|SUPERIORITY||Mean Difference (Net)|1.33|STANDARD_DEVIATION|1.88||0.04|TWO_SIDED|||||p \< 0.05|ANCOVA||The p value between RiaGev and Comparator groups at Day 5 over Day 1 is reported.|A comparison between RiaGev and Comparator supplementation.||||0.04
70877380|NCT04483011|141238883|SUPERIORITY||Mean Difference (Net)|4.01|STANDARD_DEVIATION|6.57||0.004|TWO_SIDED|||||p \< 0.05|Wilcoxon (Mann-Whitney)||The p value in the RiaGev group at Day 5 over Day 1 is reported.|A comparison between before and after RiaGev supplementation.||||0.004
70957495|NCT02495792|141418758|OTHER||Risk Ratio (RR)|5.98|||||TWO_SIDED|95.0|1.6|21.7||||||||21.7|1.6|
70957496|NCT02909764|141418759|OTHER|||||||0.3|||||||ANOVA|||||||0.30
70957497|NCT02909764|141418760|OTHER|Yates's chi-square analyses were used to determine which of the two cereals children in each group preferred at baseline and after the 8-week exposure period, and whether the number of children who shifted preference from the regular cereal at baseline to the low salt cereal after the exposure period differed between groups.|||||<|0.05|||||||Chi-squared|||Yates's chi-square analyses were used to determine which of the two cereals children in each group preferred at baseline and after the 8-week exposure period, and whether the number of children who shifted preference from the regular cereal at baseline to the low salt cereal after the exposure period differed between groups.||||<0.05
70957498|NCT02909764|141418761|OTHER|||||||0.32|||||||ANOVA|||||||0.32
70957499|NCT02909764|141418762|OTHER|||||||0.77|||||||ANOVA|||||||0.77
70957500|NCT02909764|141418763|OTHER|General estimating equations (GEE)|||||<|0.05|||||||GEE|||Generalized estimating equations (GEE) were conducted on the amount of cereal in grams ingested during 28 days home-exposure period. The GEE approach accounts for the repeated measurements of outcomes over time for each child and examines whether the slopes of the lines created differ between the treatment groups.||||<0.05
70957501|NCT02909764|141418764|OTHER|T-tests were conducted to determine whether differences in baseline blood pressure between groups|||||>|0.4|||||||t-test, 2 sided|||T-tests were conducted to determine whether differences in baseline blood pressure between the two groups.||||>0.40
70957502|NCT01850446|141418821|NON_INFERIORITY|Non-inferiority margin was prespecified as 20% (on each day). Type I error (alpha) level of 0.025 was prospectively planned for this analysis. Power of this analysis was planned to be greater than 0.8|Z-value|8.56|||<|0.0001|TWO_SIDED|||||Global test statistics (GTS) was constructed in accordance with O'Brien Procedures for Comparing Samples with Multiple Endpoints.|Z-test for Global test statistics|||Individual day analyses were combined into Global Test Statistics (patient diary analysis)||||<0.0001
70957503|NCT01850446|141418821|NON_INFERIORITY|Non-inferiority margin was prespecified as 20% (on each day). Type I error (alpha) level of 0.025 was prospectievely planned for this analysis. Power of this analysis was planned to be greater than 0.8|Z-value|7.31|||<|0.0001|TWO_SIDED|||||Global test statistics (GTS) was constructed in accordance with O'Brien, P. (1984). Procedures for Comparing Samples with Multiple Endpoints. Biometrics, 40(4), 1079-1087. doi:10.2307/2531158|Z-test for Global test statistics|||Individual day analyses were combined into Global Test Statistics (physician's examination analysis)||||<0.0001
70957504|NCT01850446|141418822|NON_INFERIORITY|Non-inferiority margin was prespecified as 1.2 degree\*day|Mean Difference (Final Values)|0.44||||0.027|ONE_SIDED|97.5|-0.23||||t-test, 1 sided|||Severity of fever was measured as area under curve (body temperature-time)|||-0.23|0.027
70957505|NCT01850446|141418823|NON_INFERIORITY|Non-inferiority magrin was prespecified as 20% of comparator duration|Mean Difference (Final Values)|0.23||||0.02|ONE_SIDED|97.5||0.63|||t-test, 1 sided|mean survival time estimates obtained from survival analysis were compared by means of t-test with infinite degrees of freedom||||0.63||0.02
70877381|NCT04483011|141238883|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_DEVIATION|3.88||0.64|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 5 over Day 1 is reported.|A comparison between before and after supplementation with Comparator.||||0.640
70957506|NCT01850446|141418824|NON_INFERIORITY|Non-inferiority margin was prespecified as 20% (on each day)|Z-value|6.95|||<|0.0001|TWO_SIDED|||||Global test statistics (GTS) was constructed in accordance with O'Brien, P. (1984). Procedures for Comparing Samples with Multiple Endpoints. Biometrics, 40(4), 1079-1087. doi:10.2307/2531158|Z-test for Global test statistics|||Individual day analyses were combined into Global Test Statistics||||<0.0001
70957507|NCT01850446|141418825|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.49|||<|0.001|ONE_SIDED|97.5||1.33|||t-test, 1 sided|||Severity of influenza symptoms (day1 morning)||1.33||<0.001
70957508|NCT01850446|141418825|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.56||||0.013|ONE_SIDED|97.5||2.59|||t-test, 1 sided|||Severity of influenza symptoms (day2 morning)||2.59||0.013
70957509|NCT01850446|141418825|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.82||||0.084|ONE_SIDED|97.5||2.66|||t-test, 1 sided|||Severity of influenza symptoms (day3 morning)||2.66||0.084
70877382|NCT04483011|141238883|SUPERIORITY||Mean Difference (Net)|4.01|STANDARD_DEVIATION|6.57||0.014|TWO_SIDED|||||p \< 0.05|ANCOVA||The p value between RiaGev and Comparator groups at Day 5 over Day 1 is reported.|A comparison between RiaGev and Comparator supplementation.||||0.014
70957510|NCT01850446|141418825|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.62||||0.22|ONE_SIDED|97.5||2.2|||t-test, 1 sided|||Severity of influenza symptoms (day4 morning)||2.2||0.22
70877383|NCT04483011|141238884|SUPERIORITY||Mean Difference (Net)|-1037.92|STANDARD_DEVIATION|1590.74||0.013|TWO_SIDED|||||p \< 0.05|Wilcoxon (Mann-Whitney)||The p value in RiaGev group at Day 8 over Day 1 is reported.|A comparison before and after RiaGev supplementation.||||0.013
70957511|NCT01850446|141418825|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.27||||0.04|ONE_SIDED|97.5||1.07|||t-test, 1 sided|||Severity of influenza symptoms (day5 morning)||1.07||0.04
70957512|NCT01850446|141418825|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.08||||0.13|ONE_SIDED|97.5||0.98|||t-test, 1 sided|||Severity of influenza symptoms (day6 morning)||0.98||0.13
70957513|NCT01850446|141418825|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.25||||0.135|ONE_SIDED|97.5||0.74|||t-test, 1 sided|||severity of influenza symptoms (day1 morning)||0.74||0.135
70957514|NCT01850446|141418825|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.64||||0.004|ONE_SIDED|97.5||2.67|||t-test, 1 sided|||Severity of influenza symptoms (day1 evening)||2.67||0.004
70877384|NCT04483011|141238884|SUPERIORITY||Mean Difference (Net)|-302.08|STANDARD_DEVIATION|1427.42||0.382|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 8 over Day 1 is reported.|A comparison before before and after supplementation with Comparator.||||0.382
70877385|NCT04483011|141238885|SUPERIORITY||Mean Difference (Net)|-135.13|STANDARD_DEVIATION|2153.66||0.793|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in RiaGev group at Day 8 over Day 1 baseline is reported.|A comparison between before and after RiaGev supplementation||||0.793
70877386|NCT04483011|141238885|SUPERIORITY||Mean Difference (Net)|-134.79|STANDARD_DEVIATION|1830.16||0.758|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 8 over Day 1 baseline is reported.|A comparison between before and after supplementation with Comparator.||||0.758
70877387|NCT04483011|141238886|SUPERIORITY||Mean Difference (Net)|70.2|STANDARD_DEVIATION|123.89||0.003|TWO_SIDED|||||p \< 0.05|Wilcoxon (Mann-Whitney)||The p value in RiaGev group at Day 5 over Day 1 is reported.|A comparison between before and after RiaGev supplementation||||0.003
70877388|NCT04483011|141238886|SUPERIORITY||Mean Difference (Net)|15.55|STANDARD_DEVIATION|88.62||0.766|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 5 over Day 1 is reported.|A comparison between before and after supplementation with Comparator.||||0.766
70877389|NCT04483011|141238887|SUPERIORITY||Mean Difference (Net)|24.01|STANDARD_DEVIATION|58.2||0.029|TWO_SIDED|||||p \< 0.05|ANCOVA||The p value between RiaGev and Comparator groups at Day 5 is reported.|A comparison between RiaGev and Comparator groups after 7-day supplementation.||||0.029
70877390|NCT04483011|141238888|SUPERIORITY||Mean Difference (Net)|-0.16|STANDARD_DEVIATION|0.32||0.034|TWO_SIDED|||||p \< 0.05|ANCOVA||The p value between RiaGev and Comparator groups at Day 5 is reported.|A comparison between RiaGev and Comparator groups.||||0.034
70877391|NCT04483011|141238889|SUPERIORITY||Mean Difference (Net)|-8.33|STANDARD_DEVIATION|12.99||0.014|TWO_SIDED|||||p \< 0.05|Wilcoxon (Mann-Whitney)||The p value in RiaGev group at Day 5 over Day 1 is reported.|A comparison between before and after RiaGev supplementation.||||0.014
70877392|NCT04483011|141238889|SUPERIORITY||Mean Difference (Net)|-2.56|STANDARD_DEVIATION|5.66||0.049|TWO_SIDED|||||p \< 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 5 over Day 1 is reported.|A comparison between before and after supplementation with Comparator.||||0.049
70877393|NCT03518073|141238893|SUPERIORITY||Posterior Mean Ratio|1.1|||||TWO_SIDED|95.0|0.959|1.265|||||Posterior mean ratio with 95% credible interval is reported.|||1.265|0.959|
70877394|NCT03518073|141238893|SUPERIORITY||Posterior Mean Ratio|1.05|||||TWO_SIDED|95.0|0.907|1.209|||||Posterior mean ratio with 95% credible interval is reported.|||1.209|0.907|
70877395|NCT03518073|141238894|SUPERIORITY||Posterior Mean Ratio|1.11|||||TWO_SIDED|95.0|0.943|1.29|||||Posterior mean ratio with 95% credible interval is reported.|||1.290|0.943|
70877396|NCT03518073|141238894|SUPERIORITY||Posterior Mean Ratio|0.89|||||TWO_SIDED|95.0|0.737|1.053|||||Posterior mean ratio with 95% credible interval is reported.|||1.053|0.737|
70877397|NCT03518073|141238895|SUPERIORITY||Posterior Mean Ratio|1.06|||||TWO_SIDED|95.0|0.873|1.284|||||Posterior mean ratio with 95% credible interval is reported.|||1.284|0.873|
70877398|NCT03518073|141238895|SUPERIORITY||Posterior Mean Ratio|1.21|||||TWO_SIDED|95.0|1.006|1.453|||||Posterior mean ratio with 95% credible interval is reported.|||1.453|1.006|
70877399|NCT03518073|141238896|SUPERIORITY||Posterior Mean Ratio|1.12|||||TWO_SIDED|95.0|0.963|1.3|||||Posterior mean ratio with 95% credible interval is reported.|||1.300|0.963|
70877400|NCT03518073|141238896|SUPERIORITY||Posterior Mean Ratio|0.95|||||TWO_SIDED|95.0|0.805|1.119|||||Posterior mean ratio with 95% credible interval is reported.|||1.119|0.805|
70877401|NCT03518073|141238897|SUPERIORITY||Posterior Mean Ratio|1.04|||||TWO_SIDED|95.0|0.88|1.221|||||Posterior mean ratio with 95% credible interval is reported.|||1.221|0.880|
70877402|NCT03518073|141238897|SUPERIORITY||Posterior Mean Ratio|0.89|||||TWO_SIDED|95.0|0.742|1.065|||||Posterior mean ratio with 95% credible interval is reported.|||1.065|0.742|
70877403|NCT03518073|141238898|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.016||0.253|TWO_SIDED|95.0|-0.01|0.05|||Mixed Models Analysis|||||0.05|-0.01|0.253
70877404|NCT03518073|141238898|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.016||0.354|TWO_SIDED|95.0|-0.02|0.05|||Mixed Models Analysis|||||0.05|-0.02|0.354
70877405|NCT03518073|141238899|SUPERIORITY||LS Mean Difference|0.62|STANDARD_ERROR_OF_MEAN|1.554||0.691|TWO_SIDED|95.0|-2.44|3.68|||Mixed Models Analysis|||||3.68|-2.44|0.691
70877406|NCT03518073|141238899|SUPERIORITY||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|1.599||0.749|TWO_SIDED|95.0|-2.64|3.66|||Mixed Models Analysis|||||3.66|-2.64|0.749
70877407|NCT03045081|141238902|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis. GEE allows for the analysis of repeated measures with unknown covariance structure and uses all available data that participants provide, even if follow-up data are missing (ie, intent-to-treat analysis). Models for the entire study sample and for only those who provided outcome data at all study time points (0, 3, 6 months; i.e., as treated 'completer' analysis) were evaluated (see Statistical Analysis 2).|||||<|0.05||||||Wald χ2 p-values \< 0.05 considered statistically significant for group x time interactions.|Wald χ2|Intent-to-treat analysis (full sample)||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improvement in pain self efficacy over time compared to the usual care group.||||<0.05
70877408|NCT03045081|141238902|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis.|||||<|0.05||||||Wald χ2 values \< 0.05 considered statistically significant for group x time interactions.|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improvement in chronic pain self-efficacy over time compared to the usual care group. This analysis was limited to those participants who provided data at each of the study time points ('completer analysis').||||<0.05
70957515|NCT01850446|141418825|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.9||||0.05|ONE_SIDED|97.5||2.94|||t-test, 1 sided|||Severity of influenza symptoms (day2 evening)||2.94||0.05
70957516|NCT01850446|141418825|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|1.34||||0.447|ONE_SIDED|97.5||3.08|||t-test, 1 sided|||Severity of influenza symptoms (day3 evening)||3.08||0.447
70957517|NCT01850446|141418825|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.08||||0.042|ONE_SIDED|97.5||1.4|||t-test, 1 sided|||Severity of influenza symptoms (day4 evening)||1.4||0.042
70957518|NCT01850446|141418825|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.29||||0.313|ONE_SIDED|97.5||1.53|||t-test, 1 sided|||Severity of influenza symptoms (day5 evening)||1.53||0.313
70957519|NCT01850446|141418825|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.27||||0.087|ONE_SIDED|97.5||0.77|||t-test, 1 sided|||Severity of influenza symptoms (day6 evening)||0.77||0.087
70957520|NCT01850446|141418825|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.43|||<|0.001|ONE_SIDED|97.5||1.41|||t-test, 1 sided|||Severity of influenza symptoms (day1 physician's objective examination)||1.41||<0.001
70957521|NCT01850446|141418825|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|1.34||||0.305|ONE_SIDED|97.5||3.11|||t-test, 1 sided|||Severity of influenza symptoms (day3 physician's objective examination)||3.11||0.305
70957522|NCT01850446|141418826|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.08||||0.02|ONE_SIDED|97.5||0.5|||t-test, 1 sided|||Fever duration||0.5||0.02
70957523|NCT01850446|141418826|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.18|||<|0.001|ONE_SIDED|97.5||0.14|||t-test, 1 sided|||Non-specific symptoms duration||0.14||<0.001
70957524|NCT01850446|141418826|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.25|||<|0.001|ONE_SIDED|97.5||0.11|||t-test, 1 sided|||Nasal/ throat/ chest symptoms duration||0.11||<0.001
70957525|NCT01850446|141418827|NON_INFERIORITY|N.I. margin was prespecified as 20% (AUC ratio supposed to be less than 1.2)|AUC ratio|1.04||||0.015|TWO_SIDED|95.0|0.9|1.17||bootstrap (100000 rep) confidence limits were constructed for AUC ratio|one-sample Z-test|AUC ratio was compared with N.I. margin||Severity of influenza was measured as area under curve (symptoms score-time)||1.17|0.9|0.015
70957526|NCT01850446|141418828|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|0.05||||0.036|ONE_SIDED|97.5||0.19|||Z test for proportions|||Percentage difference of Patients, Who Used Antipyretics (day1)||0.19||0.036
70957527|NCT01850446|141418828|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|0.01||||0.009|ONE_SIDED|97.5||0.15|||Z test for proportions|||Percentage difference of Patients, Who Used Antipyretics (day2)||0.15||0.009
70957528|NCT01850446|141418828|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|0.03|||<|0.001|ONE_SIDED|97.5||0.13|||Z test for proportions|||Percentage difference of Patients, Who Used Antipyretics (day3)||0.13||<0.001
70957529|NCT01850446|141418828|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|-0.02|||<|0.001|ONE_SIDED|97.5||0.13|||Z test for proportions|||Percentage difference of Patients, Who Used Antipyretics (day4)||0.13||<0.001
70957530|NCT01850446|141418828|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|-0.02|||<|0.001|ONE_SIDED|97.5||0.01|||Z test for proportions|||Percentage difference of Patients, Who Used Antipyretics (day5)||0.01||<0.001
70957531|NCT01850446|141418829|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|0.0|||<|0.001|ONE_SIDED|97.5||0.03|||Z test for proportions|||Percentage of Patients Requiring Antibiotics Administration||0.03||<0.001
70957532|NCT01850446|141418830|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|-0.01||||0.014|ONE_SIDED|97.5||0.15|||Z test for proportions|||Proportion difference of Patients With Negative Results (day3)||0.15||0.014
70957533|NCT01850446|141418830|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|-0.08||||0.037|ONE_SIDED|97.5||0.03|||Z test for proportions|||Proportion difference of Patients With Negative Results (day5)||0.03||0.037
70957534|NCT01850446|141418830|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|-0.03|||<|0.001|ONE_SIDED|97.5||0.03|||Z test for proportions|||Proportion difference of Patients With Negative Results (day7)||0.03||<0.001
70957535|NCT01850446|141418831|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.03|TWO_SIDED|95.0|0.19|3.59||P-value IL2 provided for between-group comparisson of difference from days 3 to day 1.|t-test, 2 sided|||difference between changes from day 1 to day 3 (IL-2)||3.59|0.19|0.03
70957536|NCT01850446|141418831|SUPERIORITY||Mean Difference (Final Values)|1.23||||0.19|TWO_SIDED|95.0|-0.64|3.12||P-value IL2 provided for between-group comparisson of difference from day 7 to day 1.|t-test, 2 sided|||difference between changes from day 1 to day 7 (IL-2)||3.12|-0.64|0.19
70957537|NCT01850446|141418831|SUPERIORITY|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (IFN-γ)||||0.012
70957538|NCT01850446|141418831|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (IFN-γ)||||<0.0001
70957539|NCT01850446|141418831|SUPERIORITY|||||||0.795|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (IL-18)||||0.795
70957540|NCT01850446|141418831|SUPERIORITY|||||||0.992|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (IL-18)||||0.992
70957541|NCT01850446|141418831|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.04|TWO_SIDED|95.0|0.02|0.92|||t-test, 2 sided|||difference between changes from day 1 to day 3 (IL-4)||0.92|0.02|0.04
70957542|NCT01850446|141418831|SUPERIORITY||Median Difference (Final Values)|0.37||||0.08|TWO_SIDED|95.0|-0.04|0.79|||t-test, 2 sided|||difference between changes from day 1 to day 7 (IL-4)||0.79|-0.04|0.08
70957543|NCT01850446|141418831|SUPERIORITY|||||||0.062|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (IL-16)||||0.062
70957544|NCT01850446|141418831|SUPERIORITY|||||||0.638|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (IL-16)||||0.638
70957545|NCT01850446|141418832|SUPERIORITY|||||||0.065|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (Spontaneous IFN-α)||||0.065
70957546|NCT01850446|141418832|SUPERIORITY|||||||0.404|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (Spontaneous IFN-α)||||0.404
70957547|NCT01850446|141418832|SUPERIORITY|||||||0.204|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (Induced IFN-α)||||0.204
70957548|NCT01850446|141418832|SUPERIORITY|||||||0.386|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (Induced IFN-α)||||0.386
70957549|NCT01850446|141418832|SUPERIORITY|||||||0.592|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (Spontaneous IFN-γ)||||0.592
70877409|NCT03045081|141238903|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis. Main effects of group and time, and group × time interactions were evaluated. Models for the entire study sample and for only those who provided outcome data at all study time points (0, 3, 6 months; 'study completers') were evaluated (see Statistical Analysis 2).||||||0.068||||||Wald χ2 p-values \< 0.05 considered statistically significant for group x time interaction|Wald χ2|Intent-to-treat analysis (full sample)||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improvement in chronic pain acceptance - Activity Engagement - over time compared to the usual care group. Note: this questionnaire has 2 subscales, Activity Engagement and Pain Willingness. Intent-to-treat and as treated analyses were conducted for each subscale.||||0.068
70877410|NCT03045081|141238903|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis.|||||<|0.05||||||Wald χ2 \<0.05 considered statistically significant for group x time interaction.|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group by time interaction, such that the PTSM group would demonstrate improvement in chronic pain acceptance - Activity Engagement - over time compared to the usual care group.This analysis was limited to those participants who provided data at each of the study time points ('completer' analysis).||||<0.05
70877411|NCT03045081|141238903|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis.||||||0.173||||||Wald χ2 \< 0.05 considered statistically significant for group x time interaction.|Wald χ2|Intent-to-treat analysis (full sample).||We hypothesized that we would observe a group by time interaction such that the PTSM group would demonstrate improvement in chronic pain acceptance - Pain Willingness - over time compared to the usual care group.||||0.173
70877412|NCT03045081|141238903|OTHER|Generalized estimating equations were used to test this hypothesis.||||||0.167||||||Wald χ2 \>0.05 considered statistically significant for group x time interaction.|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group by time interaction such that the PTSM group would demonstrate improvement in chronic pain acceptance - Pain Willingness - over time compared to the usual care group. This analysis was restricted to those study participants who provided data at each of the study time points ('completer' analysis).||||0.167
70957550|NCT01850446|141418832|SUPERIORITY|||||||0.356|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (Spontaneous IFN-γ)||||0.356
70957551|NCT01850446|141418832|SUPERIORITY|||||||0.475|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (Induced IFN-γ)||||0.475
70957552|NCT01850446|141418832|SUPERIORITY||||||>|0.99|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (Induced IFN-γ)||||>0.99
70877413|NCT03045081|141238904|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis. Main effects of group and time, and group × time interactions were evaluated. Models for the entire study sample and for only those who provided outcome data at all study time points (0, 3, 6 months) were evaluated (see Statistical Analysis 2).||||||0.176||||||Wald χ2 p-values \< 0.05 considered statistically significant for group x time interaction|Wald χ2|Intent-to-treat analysis (full sample).||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improved confidence in patient-provider interactions over time compared to the usual care group.||||0.176
70877414|NCT03045081|141238904|OTHER|Generalized estimating equations were used to test this hypothesis.||||||0.143||||||Wald χ2 \< 0.05 considered statistically significant for group x time interaction.|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improved confidence in patient-provider interactions over time compared to the usual care group. This analysis was restricted to those study participants who provided data at each of the study time points ('completer' analysis).||||0.143
70877415|NCT03045081|141238905|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis. Main effects of group and time, and group × time interactions were evaluated. Models for the entire study sample and for only those who provided outcome data at all study time points (0, 3, 6 months) were evaluated (see Statistical Analysis 2).|||||<|0.05||||||Wald χ2 p-values \< 0.05 considered statistically significant.|Wald χ2|Intent-to-treat analysis (full sample).||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improved satisfaction with pain treatment over time compared to the usual care group.||||<0.05
70877416|NCT03045081|141238905|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis.|||||<|0.001||||||Wald χ2 \< 0.05 were considered statistically significant for the group x time interaction.|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improved satisfaction with pain treatment over time compared to the usual care group. This analysis was restricted to those study participants who provided data at each of the study time points (i.e., 'completer' analysis).||||<0.001
70877417|NCT03045081|141238907|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis.Models for the entire study sample and for only those who provided outcome data at all study time points (0, 3, 6 months) were evaluated (see Statistical Analysis 2).||||||0.102||||||Wald χ2 p-values \< 0.05 considered statistically significant.|Wald χ2|Intent-to-treat analysis (full sample).||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate greater reductions in pain intensity and interference over time compared to the usual care group.||||0.102
70877418|NCT03045081|141238907|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis.|||||<|0.05||||||Wald χ2 \< 0.05 considered statistically significant for group x time interaction|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate greater reductions in pain intensity and interference over time compared to the usual care group. This analysis was restricted to those study participants who provided data at each time point (as treated, 'completer' analysis).||||<0.05
70877419|NCT01853046|141238910|SUPERIORITY_OR_OTHER||LS Mean|1.14|||||TWO_SIDED|90.0|0.796|1.63||||||Point estimates (LS-means) and 2-sided exploratory 90% confidence intervals for AUC(0-tlast) of regorafenib calculated by re-transformation of the logarithmic data from ANOVAs.||1.63|0.796|
70877420|NCT01853046|141238910|SUPERIORITY_OR_OTHER||LS-means|0.684|||||TWO_SIDED|90.0|0.397|1.18||||||Point estimates (LS-means) and 2-sided exploratory 90% confidence intervals for AUC(0-tlast) of metabolites M-2 calculated by re-transformation of the logarithmic data from ANOVAs.||1.18|0.397|
70877421|NCT01853046|141238910|SUPERIORITY_OR_OTHER||LS-means|0.446|||||TWO_SIDED|90.0|0.2|0.996||||||Point estimates (LS-means) and 2-sided exploratory 90% confidence intervals for AUC(0-tlast) of metabolites M-5 calculated by re-transformation of the logarithmic data from ANOVAs||0.996|0.200|
70877422|NCT05022784|141238940|OTHER||||||<|0.0001|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compares the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||<.0001
70877423|NCT05022784|141238941|OTHER||||||<|0.0001|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||<.0001
70877424|NCT05022784|141238942|OTHER|||||||0.37|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.37
70877425|NCT05022784|141238943|OTHER|||||||0.477|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.477
70877426|NCT05022784|141238944|OTHER|||||||0.644|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.644
70877427|NCT05022784|141238945|OTHER|||||||0.206|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.206
70877428|NCT05022784|141238946|OTHER|||||||0.052|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.052
70877429|NCT05022784|141238947|OTHER|||||||0.044|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.044
70877430|NCT05022784|141238948|OTHER|||||||0.525|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.525
70877431|NCT05022784|141238949|OTHER|||||||0.024|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.024
70877432|NCT05022784|141238950|OTHER|||||||0.016|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.016
70877433|NCT05022784|141238951|OTHER|||||||0.913|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.913
70957553|NCT01850446|141418833|SUPERIORITY|||||||0.364|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (leukocytes)||||0.364
70957554|NCT01850446|141418833|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (leukocytes)||||0.07
70957555|NCT01850446|141418833|SUPERIORITY|||||||0.607|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day1 to day 3 (neutrophils)||||0.607
70957556|NCT01850446|141418833|SUPERIORITY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (neutrophils)||||0.028
70957557|NCT01850446|141418833|SUPERIORITY|||||||0.759|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (lymphocytes)||||0.759
70957558|NCT01850446|141418833|SUPERIORITY|||||||0.777|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (lymphocytes)||||0.777
70957559|NCT01850446|141418833|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (monocytes)||||0.02
70957560|NCT01850446|141418833|SUPERIORITY|||||||0.343|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (lymphocytes)||||0.343
70957561|NCT01850446|141418833|SUPERIORITY|||||||0.575|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (eosinophils)||||0.575
70957562|NCT01850446|141418833|SUPERIORITY|||||||0.912|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (eosinophils)||||0.912
70957563|NCT01850446|141418833|SUPERIORITY|||||||0.242|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (basophils)||||0.242
70957564|NCT01850446|141418833|SUPERIORITY|||||||0.102|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (basophils)||||0.102
70957565|NCT01850446|141418833|SUPERIORITY|||||||0.429|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3+)||||0.429
70957566|NCT01850446|141418833|SUPERIORITY|||||||0.783|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3+)||||0.783
70957567|NCT01850446|141418833|SUPERIORITY|||||||0.466|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3+CD4+)||||0.466
70957568|NCT01850446|141418833|SUPERIORITY|||||||0.945|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3+CD4+)||||0.945
70957569|NCT01850446|141418833|SUPERIORITY|||||||0.335|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3+CD8+)||||0.335
70957570|NCT01850446|141418833|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3+CD8+)||||0.66
70957571|NCT01850446|141418833|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3+CD16+CD56+)||||0.01
70957572|NCT01850446|141418833|SUPERIORITY|||||||0.573|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3+CD16+CD56+)||||0.573
70877434|NCT05022784|141238952|OTHER|||||||0.448|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.448
70957573|NCT01850446|141418833|SUPERIORITY|||||||0.472|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3-CD16+CD56+)||||0.472
70957574|NCT01850446|141418833|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3-CD16+CD56+)||||0.69
70957575|NCT01850446|141418833|SUPERIORITY|||||||0.727|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3-CD8+)||||0.727
70957576|NCT01850446|141418833|SUPERIORITY|||||||0.554|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3-CD8+)||||0.554
70957577|NCT01850446|141418833|SUPERIORITY|||||||0.837|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD19+CD3-)||||0.837
70957578|NCT01850446|141418833|SUPERIORITY|||||||0.967|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD19+CD3-)||||0.967
70957579|NCT01850446|141418833|SUPERIORITY|||||||0.473|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3+CD119+)||||0.473
70957580|NCT01850446|141418833|SUPERIORITY|||||||0.736|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3+CD119+)||||0.736
70957581|NCT01850446|141418834|SUPERIORITY|||||||0.282|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of neutrophils)||||0.282
70957582|NCT01850446|141418834|SUPERIORITY|||||||0.071|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of neutrophils)||||0.071
70957583|NCT01850446|141418834|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of lymphocytes)||||0.45
70957584|NCT01850446|141418834|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of lymphocytes)||||0.58
70957585|NCT01850446|141418834|SUPERIORITY|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of monocytes)||||0.017
70957586|NCT01850446|141418834|SUPERIORITY|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of monocytes)||||0.019
70957587|NCT01850446|141418834|SUPERIORITY|||||||0.424|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of eosinophils)||||0.424
70957588|NCT01850446|141418834|SUPERIORITY|||||||0.666|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of eosinophils)||||0.666
70957589|NCT01850446|141418834|SUPERIORITY|||||||0.268|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of basophils)||||0.268
70957590|NCT01850446|141418834|SUPERIORITY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of basophils)||||0.031
70957591|NCT01850446|141418834|SUPERIORITY|||||||0.361|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3+)||||0.361
70957592|NCT01850446|141418834|SUPERIORITY|||||||0.699|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3+)||||0.699
70957593|NCT01850446|141418834|SUPERIORITY|||||||0.418|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3+CD4+)||||0.418
70957594|NCT01850446|141418834|SUPERIORITY||||||>|0.99|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3+CD4+)||||>0.99
70957595|NCT01850446|141418834|SUPERIORITY|||||||0.172|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3+CD8+)||||0.172
70957596|NCT01850446|141418834|SUPERIORITY|||||||0.904|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3+CD8+)||||0.904
70957597|NCT01850446|141418834|SUPERIORITY|||||||0.148|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3+CD16+CD56+)||||0.148
70957598|NCT01850446|141418834|SUPERIORITY|||||||0.821|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3+CD16+CD56+)||||0.821
70957599|NCT01850446|141418834|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3-CD16+CD56+)||||0.31
70877435|NCT05022784|141238953|OTHER|||||||0.515|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.515
70877436|NCT05022784|141238954|OTHER|||||||0.829|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.829
70877437|NCT05022784|141238955|OTHER|||||||0.471|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.471
70877438|NCT05022784|141238956|OTHER|||||||0.915|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.915
70957600|NCT01850446|141418834|SUPERIORITY||||||>|0.99|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3-CD16+CD56+)||||>0.99
70957601|NCT01850446|141418834|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3-CD8+)||||0.43
70877439|NCT05022784|141238957|OTHER|||||||0.19|||||||Chi-squared|||||||0.190
70957602|NCT01850446|141418834|SUPERIORITY|||||||0.821|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3-CD8+)||||0.821
70877440|NCT05022784|141238958|OTHER|||||||0.928|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.928
70957603|NCT01850446|141418834|SUPERIORITY|||||||0.943|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD19+CD3-)||||0.943
70877441|NCT05022784|141238959|OTHER|||||||0.49|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.490
70877442|NCT05022784|141238960|OTHER|||||||0.667|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.667
70957604|NCT01850446|141418834|SUPERIORITY|||||||0.841|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD19+CD3-)||||0.841
70877443|NCT05022784|141238961|OTHER|||||||0.032|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.032
70877444|NCT05022784|141238962|OTHER|||||||0.721|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.721
70877445|NCT05022784|141238963|OTHER|||||||0.352|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.352
70877446|NCT05022784|141238964|OTHER|||||||0.136|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.136
70957605|NCT00759915|141418853|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|109.98||||||90.0|100.1|120.8|||ANOVA|log-transformation||||120.8|100.1|
70877447|NCT05022784|141238965|OTHER|||||||0.27|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.270
70877448|NCT05022784|141238966|OTHER|||||||0.306|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.306
70877449|NCT05022784|141238967|OTHER|||||||0.145|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.145
70877450|NCT05022784|141238968|OTHER|||||||0.109|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.109
70877451|NCT05022784|141238969|OTHER|||||||0.454|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.454
70877452|NCT05022784|141238970|OTHER|||||||0.96|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.960
70877453|NCT05022784|141238971|OTHER|||||||0.265|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.265
70877454|NCT05022784|141238972|OTHER|||||||0.026|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.026
70877455|NCT05022784|141238973|OTHER|||||||0.016|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.016
70877456|NCT05022784|141238974|OTHER|||||||0.937|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.937
70877457|NCT05022784|141238975|OTHER|||||||0.948|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.948
70877458|NCT05022784|141238976|OTHER|||||||0.574|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.574
70877459|NCT05022784|141238977|OTHER|||||||0.491|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.491
70877460|NCT05022784|141238978|OTHER|||||||0.432|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.432
70877461|NCT00708162|141238984|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: the EVG group was at least 10% worse than the RAL group with respect to percentage of participants achieving and maintaining HIV-1 RNA \< 50 copies/mL through Week 48; alternative hypothesis: the EVG group was less than 10% worse than the RAL group.|Difference in percentages|1.1|||||TWO_SIDED|95.0|-6.0|8.2|||||The difference in percentages and its 95% confidence interval (CI) were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using Mantel-Haenszel (MH) proportions and normal approximation.|The planned sample size of 700 HIV-1 infected participants, (350 in each group) was estimated to provide at least 85% power to establish noninferiority in the percentage of participants achieving and maintaining confirmed HIV-1 RNA \< 50 copies/mL through Week 48. For sample size and power computation, it was assumed that both elvitegravir and raltegravir arms have a response rate of 0.74, that a noninferiority margin was 0.10, and that the significance level of the test was 1-sided 0.025 level.||8.2|-6.0|
70877462|NCT00708162|141238985|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: the EVG arm was at least 10% worse than the RAL arm with respect to percentage of participants achieving and maintaining HIV-1 RNA \< 50 copies/mL through Week 48; alternative hypothesis: the EVG arm was less than 10% worse than the RAL arm.|Difference in percentages|2.6|||||TWO_SIDED|95.0|-4.6|9.9|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||9.9|-4.6|
70877463|NCT00708162|141238986|SUPERIORITY_OR_OTHER||Difference in percentages|0.9|||||TWO_SIDED|95.0|-6.0|7.7|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||7.7|-6.0|
70877464|NCT00708162|141238987|SUPERIORITY_OR_OTHER||Difference in percentages|0.9|||||TWO_SIDED|95.0|-6.4|8.2|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||8.2|-6.4|
70877465|NCT00708162|141238988|SUPERIORITY_OR_OTHER||Difference in percentages|2.2|||||TWO_SIDED|95.0|-5.0|9.3|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||9.3|-5.0|
70877466|NCT00708162|141238989|SUPERIORITY_OR_OTHER||Difference in percentages|-0.5|||||TWO_SIDED|95.0|-7.9|6.8|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||6.8|-7.9|
70877467|NCT00708162|141238994|SUPERIORITY_OR_OTHER||Difference in percentages|0.2|||||TWO_SIDED|95.0|-6.9|7.3|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||7.3|-6.9|
70877468|NCT00708162|141238995|SUPERIORITY_OR_OTHER||Difference in percentages|-2.9|||||TWO_SIDED|95.0|-10.2|4.4|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||4.4|-10.2|
70877469|NCT00708162|141238996|SUPERIORITY_OR_OTHER||Difference in percentages|-2.0|||||TWO_SIDED|95.0|-8.6|4.7|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||4.7|-8.6|
70877470|NCT00708162|141238997|SUPERIORITY_OR_OTHER||Difference in percentages|-1.7|||||TWO_SIDED|95.0|-8.8|5.5|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||5.5|-8.8|
70877471|NCT00708162|141238998|SUPERIORITY_OR_OTHER||Difference in log10 copies/mL|0.01|||||TWO_SIDED|95.0|-0.16|0.19|||||The difference in least squares means (LSM) and its 95% CI were obtained using an analysis of variance model (ANOVA) adjusting for baseline HIV-1 RNA level and class of the second agent (NRTI or other classes).|||0.19|-0.16|
70877472|NCT00708162|141238999|SUPERIORITY_OR_OTHER||Difference in log10 copies/mL|0.05|||||TWO_SIDED|95.0|-0.12|0.22|||||The difference in LSM and its 95% CI were obtained using ANOVA adjusting for baseline HIV-1 RNA level and class of the second agent (NRTI or other classes).|||0.22|-0.12|
70877473|NCT00708162|141239000|SUPERIORITY_OR_OTHER||Difference in cells/mm^3|-9.0|||||TWO_SIDED|95.0|-33.0|16.0|||||The difference in LSM and its 95% CI were obtained using ANOVA adjusting for baseline HIV-1 RNA level and class of the second agent (NRTI or other classes).|||16|-33|
70877474|NCT00708162|141239001|SUPERIORITY_OR_OTHER||Difference in cells/mm^3|7.0|||||TWO_SIDED|95.0|-25.0|39.0|||||The difference in LSM and its 95% CI were obtained using ANOVA adjusting for baseline HIV-1 RNA level and class of the second agent (NRTI or other classes).|||39|-25|
70957606|NCT00759915|141418855|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|100.91||||||90.0|96.96|105.0|||ANOVA|log-transformation||||105.0|96.96|
70877475|NCT00708643|141239006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0047|STANDARD_ERROR_OF_MEAN|2.2863|||TWO_SIDED|98.75|-3.0047|2.7153|||Mixed Models Analysis||The mean difference is calculated as narafilcon A minus the habitual lens.|The alternative hypothesis is that narafilcon A will provide a lower level of limbal hyperemia than the habitual lens.||2.7153|-3.0047|
70877476|NCT00708643|141239007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0804|STANDARD_ERROR_OF_MEAN|0.7605|||TWO_SIDED|99.0|-0.0804|1.8821|||Mixed Models Analysis||The mean difference is calculated as narafilcon A minus habitual lens.|The alternative hypothesis is that narafilcon A provides better comfort than the habitual lens by having a lower rating on the scale.||1.8821|-0.0804|
70877477|NCT00708643|141239008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2228|STANDARD_ERROR_OF_MEAN|1.7002|||TWO_SIDED|99.0|0.2228|4.6564|||Mixed Models Analysis||The mean difference is calculated as narafilcon A minus the habitual lens.|The alternative hypothesis is that narafilcon A provides a lowe level of upper lid margin staining than the habitual lens.||4.6564|0.2228|
70877478|NCT00708643|141239009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2596|STANDARD_ERROR_OF_MEAN|1.1873|||TWO_SIDED|98.75|1.2596|4.2599|||Mixed Models Analysis||The mean difference is calculated as narafilcon A minus the habitual lens.|||4.2599|1.2596|
70877479|NCT00708643|141239010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8625|STANDARD_ERROR_OF_MEAN|2.3407|||TWO_SIDED|98.75|-0.8625|5.0524|||Mixed Models Analysis||The mean difference is calculated as narafilcon A minus habitual lens.|The alternative hypothesis is that narafilcon A provides a lower level of tarsal hyperemia than the habitual lens.||5.0524|-0.8625|
70877480|NCT00708643|141239011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.241|STANDARD_ERROR_OF_MEAN|1.6975|||TWO_SIDED|98.75|-0.241|4.0043|||Mixed Models Analysis||The mean difference is calculated as narafilcon A minus habitual lens.|The alternative hypothesis is that narafilcon A provides lower levels of corneal staining than the habitual lens.||4.0043|-0.2410|
70877481|NCT00065507|141239012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.74|||<|0.0001|TWO_SIDED|95.0|-2.3|-1.18|||Regression, Linear|Linear regression model adjusted for baseline HBV DNA and LVDr status.||||-1.18|-2.30|<0.0001
70877482|NCT00065507|141239013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.85|-0.96|||Regression, Linear|adjusted for baseline HBV DNA and LVDr Status||||-0.96|-1.85|<0.0001
70877483|NCT00065507|141239014|SUPERIORITY_OR_OTHER||Mean Percent Difference|32.7|||<|0.0001|TWO_SIDED|95.0|20.2|45.2|||Cochran-Mantel-Haenszel|||||45.2|20.2|<0.0001
70877484|NCT00065507|141239015|SUPERIORITY_OR_OTHER||Mean percent treatment difference|38.0|||<|0.0001|TWO_SIDED|95.0|24.8|50.3|||Cochran-Mantel-Haenszel|||||50.3|24.8|<0.0001
70877485|NCT00065507|141239016|SUPERIORITY_OR_OTHER||percent treatment difference|19.2||||0.0193|TWO_SIDED|95.0|3.7|34.6|||Cochran-Mantel-Haenszel|||Week 24 treatment difference||34.6|3.7|0.0193
70877486|NCT00065507|141239016|SUPERIORITY_OR_OTHER||percent treatment difference|16.4||||0.0425|TWO_SIDED|95.0|0.9|32.0|||Cochran-Mantel-Haenszel|||Week 48 treatment difference||32.0|0.9|0.0425
70877487|NCT00065507|141239022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.51|TWO_SIDED|95.0|-1.63|0.82|||Regression, Linear|Model estimate incorporates prognostic factors measured at baseline. Adjusted for baseline||Covariate adjusted model for MELD score at Week 24||0.82|-1.63|0.51
70957607|NCT00759915|141418856|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|96.5||||||90.0|92.3|100.97|||ANOVA|log-transformation||||100.97|92.3|
70877488|NCT00065507|141239022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59|||<|0.0001|TWO_SIDED|95.0|-1.08|1.88|||Regression, Linear|Model estimate incorporates prognostic factors measured at baseline. Adjusted for baseline||Covariate adjusted model for MELD score at Week 48||1.88|-1.08|<0.0001
70877489|NCT00065507|141239030|SUPERIORITY_OR_OTHER||Difference Estimate|10.4|||||TWO_SIDED|95.0|-4.5|25.2||||||Difference estimate ETV - ADV at Week 48||25.2|-4.5|
70877490|NCT00065507|141239031|SUPERIORITY_OR_OTHER||Difference Estimate|-0.4|||||TWO_SIDED|95.0|-8.7|8.0||||||Difference Estimate at Week 48||8.0|-8.7|
70877491|NCT00065507|141239032|SUPERIORITY_OR_OTHER||Difference Estimate|-7.2|||||TWO_SIDED|95.0|-21.3|6.9||||||Difference Estimate at Week 48||6.9|-21.3|
70877492|NCT00065507|141239033|SUPERIORITY_OR_OTHER||Difference Estimate|5.7|||||TWO_SIDED|95.0|-0.3|11.7||||||Difference Estimate at Week 48||11.7|-0.3|
70877493|NCT00065507|141239034|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.2|TWO_SIDED|95.0|0.46|1.18|||Regression, Cox|Cox proportional hazard model, adjusted for age \<=45 versus age \>45 years, gender, and race (white versus non-white).||treatment comparison of HCC-free survival at Week 48||1.18|0.46|0.20
70877494|NCT03108027|141239098|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|0.6096|||||TWO_SIDED|90.0|0.538|0.6811|||Mixed Models Analysis|||||0.6811|0.5380|
70877495|NCT03108027|141239098|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|0.6152|||||TWO_SIDED|90.0|0.5437|0.6868|||Mixed Models Analysis|||||0.6868|0.5437|
70877496|NCT03108027|141239098|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|-0.0057|||||TWO_SIDED|90.0|-0.076|0.0647|||Mixed Models Analysis|||||0.0647|-0.0760|
70877497|NCT03108027|141239099|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|0.6206|||||TWO_SIDED|90.0|0.5335|0.7077|||Mixed Models Analysis|||||0.7077|0.5335|
70877498|NCT03108027|141239099|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|0.7347|||||TWO_SIDED|90.0|0.6469|0.8225|||Mixed Models Analysis|||||0.8225|0.6469|
70877499|NCT03108027|141239099|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|-0.1141|||||TWO_SIDED|90.0|-0.197|-0.0311|||Mixed Models Analysis|||||-0.0311|-0.1970|
70957608|NCT03527173|141418865|NON_INFERIORITY|VE in reduction of shigellosis is demonstrated if lower limit (LL) of 90% CI of VE estimated with Miettinen-Nurminen (M-N) method is above 0. This estimated CI was complemented with Barnard test. The LL of the 90% CI for VE calculated with M-N method is above 0 if the p-value of the one-sided Barnard test is below 5%.|Vaccine efficacy rate|-9.4||||0.4266|TWO_SIDED|90.0|-96.7|33.7|||1-sided Barnard Unconditional Exact Test|||To demonstrate the efficacy of two vaccinations with 25 µg of S. sonnei vaccine in healthy adults compared to placebo in preventing shigellosis, fulfilling the protocol primary case definition, after challenge with S. sonnei 53G strain. Vaccine efficacy (VE) rate was assessed as 1-Risk Ratio(RR) with RR = ratio of proportion of subjects with shigellosis in the vaccinated group on the proportion of subjects with shigellosis in the placebo group.||33.7|-96.7|0.4266
70957609|NCT01248780|141418891|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70957610|NCT01248780|141418892|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70957611|NCT01248780|141418893|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70957612|NCT01248780|141418894|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
70957613|NCT01190514|141418915|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for AUC48 fell wholly within (80%, 125%).|ratio (%) of adjusted geometric means|95.56|||||TWO_SIDED|90.0|86.94|105.04|||Mixed Models Analysis||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"DVS SR 25 mg\*2 fasted (test); DVS SR 50 mg fasted (reference).~Natural log transformed AUC48: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."||105.04|86.94|
70957614|NCT01190514|141418915|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for AUC48 fell wholly within (80%, 125%).|ratio (%) of adjusted geometric means|101.31|||||TWO_SIDED|90.0|97.17|105.64|||Mixed Models Analysis||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"DVS SR 25 mg\*2 fed (test); DVS SR 50 mg fed (reference).~Natural log transformed AUC48: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."||105.64|97.17|
70877500|NCT03108027|141239100|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|72.1|||||TWO_SIDED|90.0|61.3|82.9|||Mixed Models Analysis|||Morning average PEF||82.9|61.3|
70957615|NCT01190514|141418915|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for AUC48 fell wholly within (80%, 125%).|ratio (%) of adjusted geometric means|108.76|||||TWO_SIDED|90.0|101.1|117.01|||Mixed Models Analysis||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Food effect DVS SR 50 mg fed (test) versus DVS SR 50 mg fasted (reference).~Natural log transformed AUC48: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."||117.01|101.10|
70957616|NCT01190514|141418917|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for Cmax fell wholly within (80%, 125%).|Ratio (%) of adjusted geometric means|95.1|||||TWO_SIDED|90.0|89.37|101.2|||Mixed Models Analysis||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"DVS SR 25 mg\*2 fasted (test); DVS SR 50 mg fasted (reference).~Natural log transformed Cmax: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."||101.20|89.37|
70957617|NCT01190514|141418917|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for Cmax fell wholly within (80%, 125%).|Ratio (%) of adjusted geometric means|101.3|||||TWO_SIDED|90.0|94.66|108.4|||Mixed Models Analysis||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"DVS SR 25 mg\*2 fed (test); DVS SR 50 mg fed (reference).~Natural log transformed Cmax: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."||108.40|94.66|
70957618|NCT01190514|141418917|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for Cmax fell wholly within (80%, 125%).|ratio (%) of adjusted geometric means|115.54|||||TWO_SIDED|90.0|108.59|122.94|||Mixed Models Analysis||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Food effect DVS SR 50 mg fed (test) versus DVS SR 50 mg fasted (reference).~Natural log transformed Cmax: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."||122.94|108.59|
70957619|NCT04101318|141418951|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.625|TWO_SIDED|95.0|-0.38|0.62||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.62|-0.38|0.625
70957620|NCT04101318|141418952|SUPERIORITY||Odds Ratio (OR)|1.737||||0.036|TWO_SIDED|95.0|1.038|2.908||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Proportional odds ratio model|Ordinal regression model for itching evaluated on a 5 point scale. Product and period are fixed effects and subject is a random effect.|Odds ratio, marginal= Arm1/Arm2|Null hypothesis: There is no difference between the two arms.||2.908|1.038|0.036
70957621|NCT04101318|141418953|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.202|TWO_SIDED|95.0|-0.9|0.2||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|The mode had following fixed effects: product and period. Subject and the interaction between product and subject were random effects.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.20|-0.90|0.202
70877501|NCT03108027|141239100|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|86.9|||||TWO_SIDED|90.0|76.1|97.8|||Mixed Models Analysis|||Morning average PEF||97.8|76.1|
70877502|NCT03108027|141239100|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|-14.8|||||TWO_SIDED|90.0|-25.6|-4.1|||Mixed Models Analysis|||Morning average PEF||-4.1|-25.6|
70877503|NCT03108027|141239100|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|73.1|||||TWO_SIDED|90.0|61.9|84.2|||Mixed Models Analysis|||Evening average PEF||84.2|61.9|
70877504|NCT03108027|141239100|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|58.7||||||90.0|47.5|69.9|||Mixed Models Analysis|||Evening average PEF||69.9|47.5|
70877505|NCT03108027|141239100|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|14.4|||||TWO_SIDED|90.0|3.3|25.5|||Mixed Models Analysis|||Evening average PEF||25.5|3.3|
70877506|NCT00268996|141239101|SUPERIORITY_OR_OTHER||Adjusted percentage change|-11.717||||0.348|TWO_SIDED|95.0|-31.995|14.607|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100\]|||14.607|-31.995|0.348
70877507|NCT00268996|141239102|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|-0.082||||0.22|TWO_SIDED|95.0|-0.214|0.049|||ANCOVA||Difference in adjusted means is shown (Darapladib 160 mg EC tablet - Placebo).|||0.049|-0.214|0.220
70877508|NCT00268996|141239103|SUPERIORITY_OR_OTHER||Adjusted percentage change|3.977||||0.751|TWO_SIDED|95.0|-18.331|32.379|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100\]|||32.379|-18.331|0.751
70877509|NCT00268996|141239104|SUPERIORITY_OR_OTHER||Adjusted percentage change|-60.737|||<|0.001|TWO_SIDED|95.0|-63.486|-57.78|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet at Week 26 (LOCF)||-57.780|-63.486|<0.001
70877510|NCT00268996|141239104|SUPERIORITY_OR_OTHER||Adjusted percentage change|-59.326|||<|0.001|TWO_SIDED|95.0|-62.21|-56.222|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet at Week 52 (LOCF)||-56.222|-62.210|<0.001
70877511|NCT00268996|141239105|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|0.253||||0.945|TWO_SIDED|95.0|-6.998|7.504|||ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet - Placebo).|||7.504|-6.998|0.945
70877512|NCT00268996|141239106|SUPERIORITY_OR_OTHER||Difference in adjusted means|-0.062||||0.898|TWO_SIDED|95.0|-1.009|0.886|||ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet - Placebo).|||0.886|-1.009|0.898
70877513|NCT00268996|141239107|SUPERIORITY_OR_OTHER||Difference in adjusted means|-5.165||||0.012|TWO_SIDED|95.0|-9.185|-1.145|||ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet - Placebo).|||-1.145|-9.185|0.012
70957622|NCT04101318|141418954|SUPERIORITY||Odds Ratio (OR)|1.369||||0.267|TWO_SIDED|95.0|0.781|2.401||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Proportional odds ratio model|Ordinal regression model for pain evaluated on a 5 point scale. Product and period are fixed effects and subject is a random effect.|Odds ratio, marginal= Arm1/Arm2|Null hypothesis: There is no difference between the two arms.||2.401|0.781|0.267
70877514|NCT00268996|141239108|SUPERIORITY_OR_OTHER||Difference in adjusted means|-1.967||||0.047|TWO_SIDED|95.0|-3.912|-0.022|||ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet - Placebo).|||-0.022|-3.912|0.047
70877515|NCT00268996|141239109|SUPERIORITY_OR_OTHER||Adjusted percentage change|6.958||||0.487|TWO_SIDED|95.0|-11.568|29.364|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100\]|Week 26 (LOCF): Comparison between Placebo vs Darapladib 160 mg EC tablet||29.364|-11.568|0.487
70877516|NCT00268996|141239109|SUPERIORITY_OR_OTHER||Adjusted percentage change|12.255||||0.247|TWO_SIDED|95.0|-7.725|36.562|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100\]|Week 52 (LOCF): Comparison between Placebo Vs Darapladib 160 mg EC tablet||36.562|-7.725|0.247
70877517|NCT00268996|141239110|SUPERIORITY_OR_OTHER||Adjusted percentage change|-1.112||||0.687|TWO_SIDED|95.0|-6.363|4.433|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 26 (LOCF)||4.433|-6.363|0.687
70877518|NCT00268996|141239110|SUPERIORITY_OR_OTHER||Adjusted percentage change|-3.237||||0.29|TWO_SIDED|95.0|-8.976|2.865|||ANOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|||2.865|-8.976|0.290
70877519|NCT00268996|141239111|SUPERIORITY_OR_OTHER||Adjusted percentage change|16.725||||0.022|TWO_SIDED|95.0|2.232|33.271|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 26 (LOCF)||33.271|2.232|0.022
70877520|NCT00268996|141239111|SUPERIORITY_OR_OTHER||Adjusted percentage change|9.256||||0.252|TWO_SIDED|95.0|-6.136|27.172|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 52 (LOCF)||27.172|-6.136|0.252
70877521|NCT00268996|141239112|SUPERIORITY_OR_OTHER||Adjusted percentage change|15.449||||0.196|TWO_SIDED|95.0|-7.204|43.632|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 26||43.632|-7.204|0.196
70877522|NCT00268996|141239112|SUPERIORITY_OR_OTHER||Adjusted percentage change|38.567||||0.024|TWO_SIDED|95.0|4.355|83.997|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 52||83.997|4.355|0.024
70877523|NCT00268996|141239113|SUPERIORITY_OR_OTHER||Adjusted percentage change|-2.098||||0.79|TWO_SIDED|95.0|-16.303|14.517|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 26 (LOCF)||14.517|-16.303|0.790
70877524|NCT00268996|141239113|SUPERIORITY_OR_OTHER||Adjusted percentage change|1.986||||0.818|TWO_SIDED|95.0|-13.807|20.673|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 52 (LOCF)||20.673|-13.807|0.818
70877525|NCT00268996|141239114|SUPERIORITY_OR_OTHER||Adjusted percentage change|-0.252||||0.98|TWO_SIDED|95.0|-18.151|21.561|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 26 (LOCF)||21.561|-18.151|0.980
70877526|NCT00268996|141239114|SUPERIORITY_OR_OTHER||Adjusted percentage change|-8.585||||0.663|TWO_SIDED|95.0|-39.007|37.012|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 52 (LOCF)||37.012|-39.007|0.663
70877527|NCT00268996|141239116|SUPERIORITY_OR_OTHER||Adjusted treatment Difference|1.758||||0.811|TWO_SIDED|95.0|-12.675|16.192|||ANCOVA||Difference in adjusted means are shown (Darapladib 160mg EC tablet once daily - Placebo).|For vessel volume||16.192|-12.675|0.811
70877528|NCT00268996|141239116|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|2.627||||0.708|TWO_SIDED|95.0|-11.171|16.425|||ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet once daily - Placebo).|For lumen volume||16.425|-11.171|0.708
70877529|NCT00268996|141239117|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|-0.012||||0.873|TWO_SIDED|95.0|-0.16|0.136||Data analyzed using ANCOVA, with ACS status, pooled country, baseline value , matched segment length and treatment included as covariates.|ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Mean vessel area||0.136|-0.160|0.873
70877530|NCT00268996|141239117|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|0.048||||0.756|TWO_SIDED|95.0|-0.258|0.354|||ANCOVA|Data analyzed using ANCOVA, with ACS status, pooled country, baseline value , matched segment length and treatment included as covariates.|Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Mean vessel area||0.354|-0.258|0.756
70877531|NCT00268996|141239117|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|0.061||||0.687|TWO_SIDED|95.0|-0.237|0.36|||ANCOVA|Data analyzed using ANCOVA, with ACS status, pooled country, baseline value , matched segment length and treatment included as covariates.|Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Mean lumen area||0.360|-0.237|0.687
70877532|NCT00268996|141239118|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|-0.584||||0.854|TWO_SIDED|95.0|-6.819|5.65|||ANCOVA|Data analyzed using ANCOVA, with ACS status, pooled country, baseline value, matched segment length and treatment included as covariates.|Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Fibrous tissue volume||5.650|-6.819|0.854
70877533|NCT00268996|141239118|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|1.926||||0.418|TWO_SIDED|95.0|-2.748|6.6||Data analyzed using ANCOVA, with ACS status, pooled country, baseline value, matched segment length and treatment included as covariates.|ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Fibro-fatty volume||6.600|-2.748|0.418
70877534|NCT00268996|141239119|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|2.0||||0.021|TWO_SIDED|95.0|0.299|3.701|||ANOVA|Data analyzed using ANCOVA, with ACS status, pooled country, baseline value, matched segment length and treatment included as covariates.|Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Fibrous tissue as % of VH plaque||3.701|0.299|0.021
70877535|NCT00268996|141239119|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|0.739||||0.54|TWO_SIDED|95.0|-1.635|3.114|||ANCOVA|Data analyzed using ANCOVA, with ACS status, pooled country, baseline value, matched segment length and treatment included as covariates.|Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Fibro-fatty as percentage of VH plaque||3.114|-1.635|0.540
70877536|NCT00576927|141239139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.655|TWO_SIDED|95.0|0.156|8.717||p-value suspect because of sparse cell counts|Chi-squared|||||8.717|0.156|0.655
70877537|NCT03171415|141239160|SUPERIORITY||||||>|0.05|TWO_SIDED|5.0|||||Kruskal-Wallis|||The Kruskal-Wallis T-test was applied for analyzing the difference in between the study groups||||>0.05
70877538|NCT03171415|141239160|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|||The Kruskal-Wallis T-test was applied for analyzing the difference in between the study groups, at day 28 and Day 56||||<0.05
70877539|NCT03171415|141239160|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|||The Kruskal-Wallis T-test was applied for analyzing the difference in between the study groups||||<0.05
70877540|NCT03171415|141239160|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|||The Kruskal-Wallis T-test was applied for analyzing the difference in between the study groups||||<0.05
70877541|NCT03171415|141239161|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
70877542|NCT03171415|141239161|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
70877543|NCT03171415|141239161|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
70877544|NCT03171415|141239161|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
70877545|NCT03171415|141239167|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
70877546|NCT03715764|141239169|SUPERIORITY|||||||0.87||||||Results for the final model, variable GROUP, adjusted for confounders.|Mixed Models Analysis|||||||0.87
70877547|NCT03715764|141239169|SUPERIORITY||||||<|0.001||||||Results for the final model for the variable TIME, adjusted for confounders.|Mixed Models Analysis|||||||<0.001
70877548|NCT03715764|141239169|SUPERIORITY|||||||0.18||||||Results for the final model, variable Group x Time (Statistical interaction of group and time), adjusted for confounders.|Mixed Models Analysis|||||||0.18
70957623|NCT04101318|141418955|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.545|TWO_SIDED|95.0|-0.57|0.3||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.30|-0.57|0.545
70957624|NCT04101318|141418956|SUPERIORITY||Odds Ratio (OR)|1.316||||0.293|TWO_SIDED|95.0|0.783|2.211||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Proportional odds ratio model|Ordinal regression model for burning evaluated on a 5 point scale. Product and period are fixed effects and subject is a random effect.|Odds ratio, marginal= Arm1/Arm2|Null hypothesis: There is no difference between the two arms.||2.211|0.783|0.293
70957625|NCT04101318|141418957|SUPERIORITY||Odds Ratio (OR)|0.82||||0.375|TWO_SIDED|95.0|0.53|1.27||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|generalized linear mixed repeated model with fixed effects|Odds ratio, marginal= Arm1/Arm2|There is no difference between the two arms.||1.27|0.53|0.375
70957626|NCT04101318|141418958|SUPERIORITY||Odds Ratio (OR)|0.83||||0.482|TWO_SIDED|95.0|0.49|1.4||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|generalized linear mixed repeated model with fixed effects|Odds ratio, marginal= Arm1/Arm2|Null hypothesis: There is no difference between the two arms.||1.40|0.49|0.482
70957627|NCT04101318|141418959|SUPERIORITY||Odds Ratio (OR)|0.7||||0.151|TWO_SIDED|95.0|0.43|1.14||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|generalized linear mixed repeated model with fixed effects||Null hypothesis: There is no difference between the two arms.|Odds ratio, marginal= Arm1/Arm2|1.14|0.43|0.151
70957628|NCT04101318|141418960|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.725|TWO_SIDED|95.0|-0.39|0.56||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.56|-0.39|0.725
70957629|NCT04101318|141418961|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.721|TWO_SIDED|95.0|-0.39|0.56||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.56|-0.39|0.721
70957630|NCT04101318|141418962|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.753|TWO_SIDED|95.0|-0.38|0.28||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.28|-0.38|0.753
70957631|NCT04101318|141418963|SUPERIORITY||Mean Difference (Final Values)|1.37||||0.331|TWO_SIDED|95.0|-1.43|4.18||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||4.18|-1.43|0.331
70957632|NCT04101318|141418964|SUPERIORITY||Mean Difference (Final Values)|11.68||||0.239|TWO_SIDED|95.0|-7.98|31.34||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||31.34|-7.98|0.239
70957633|NCT04101318|141418965|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.322|TWO_SIDED|95.0|-0.91|0.31||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject was a random effect.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.31|-0.91|0.322
70957634|NCT04101318|141418966|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.343|TWO_SIDED|95.0|-0.44|0.15||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject was a random effect.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.15|-0.44|0.343
70957635|NCT04101318|141418967|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.387|TWO_SIDED|95.0|-0.53|0.21||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject was a random effect.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.21|-0.53|0.387
70957636|NCT04101318|141418968|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.899|TWO_SIDED|95.0|-0.18|0.16||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject was a random effect.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.16|-0.18|0.899
70877549|NCT03715764|141239170|SUPERIORITY|||||||0.56||||||Results for the final model, variable GROUP, adjusted for confounders.|Mixed Models Analysis|||||||0.56
70877550|NCT03715764|141239170|SUPERIORITY|||||||0.0049||||||Results for the final model, variable TIME, adjusted for confounders.|Mixed Models Analysis|||||||0.0049
70877551|NCT03715764|141239170|SUPERIORITY|||||||0.49||||||Results for the final model, adjusted for confounders, for the variable Group x Time (Statistical interaction of group and time).|Mixed Models Analysis|||||||0.49
70877552|NCT03715764|141239171|SUPERIORITY|Used as a confounder in the mixed effect model analysis for primary outcome. All participants enrolled in the study were included in the 12 months analysis.|||||<|0.2||||||Confounding variables with p-values \< 0.2 were carried forward to the final model.|Mixed Models Analysis|||||||<0.2
70957637|NCT01874431|141418969|OTHER||Least square mean ratio|0.926||||0.1973|TWO_SIDED|90.0|0.799|1.074|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an analysis of covariance (ANCOVA) with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a last-observation carried-forward (LOCF) method for missing observations.||1.074|0.799|0.1973
70957638|NCT01874431|141418969|OTHER||Least square mean ratio|0.949||||0.2808|TWO_SIDED|90.0|0.818|1.101|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.||1.101|0.818|0.2808
70957639|NCT01874431|141418969|OTHER||Least square mean ratio|0.878||||0.0723|TWO_SIDED|90.0|0.758|1.017|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.||1.017|0.758|0.0723
70957640|NCT01874431|141418969|OTHER||Least square mean ratio|0.787||||0.0039|TWO_SIDED|90.0|0.68|0.912|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.||0.912|0.68|0.0039
70957641|NCT01874431|141418969|OTHER||Least square mean ratio|0.755||||0.0009|TWO_SIDED|90.0|0.651|0.875|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.||0.875|0.651|0.0009
70957642|NCT01874431|141418969|OTHER||Least square mean ratio|0.671|||<|0.0001|TWO_SIDED|90.0|0.584|0.772|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.||0.772|0.584|< 0.0001
70957643|NCT01874431|141418969|OTHER||Least square mean ratio|0.624|||<|0.0001|TWO_SIDED|90.0|0.542|0.718|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.||0.718|0.542|< 0.0001
70957644|NCT01874431|141418970|OTHER||Least squares mean difference|0.107||||0.0428|TWO_SIDED|95.0|0.003|0.21|||t-test, 2 sided|||||0.21|0.003|0.0428
70957645|NCT01874431|141418970|OTHER||Least squares mean difference|0.121||||0.0223|TWO_SIDED|95.0|0.017|0.225|||t-test, 2 sided|||||0.225|0.017|0.0223
70957646|NCT01874431|141418970|OTHER||Least squares mean difference|0.2||||0.0002|TWO_SIDED|95.0|0.096|0.305|||t-test, 2 sided|||||0.305|0.096|0.0002
70957647|NCT01874431|141418970|OTHER||Least squares mean difference|0.125||||0.0181|TWO_SIDED|95.0|0.021|0.229|||t-test, 2 sided|||||0.229|0.021|0.0181
70957648|NCT01874431|141418970|OTHER||Least squares mean difference|0.166||||0.0019|TWO_SIDED|95.0|0.061|0.27|||t-test, 2 sided|||||0.27|0.061|0.0019
70877553|NCT03715764|141239172|SUPERIORITY|Used as a confounder in the mixed effect model analysis for primary outcome. All participants enrolled in the study were included in the 12 months analysis.|||||<|0.2||||||Confounding variables with p-values \< 0.2 were carried forward to the final model.|Mixed Models Analysis|||||||<0.2
70877554|NCT01338493|141239175|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70877555|NCT01338493|141239176|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70877556|NCT03194698|141239223|SUPERIORITY|||||||0.0312|||||||Wilcoxon (Mann-Whitney)|||||||0.0312
70957649|NCT01874431|141418970|OTHER||Least squares mean difference|0.236|||<|0.0001|TWO_SIDED|95.0|0.137|0.334|||t-test, 2 sided|||||0.334|0.137|< 0.0001
70957650|NCT01874431|141418970|OTHER||Least squares mean difference|0.186||||0.0002|TWO_SIDED|95.0|0.088|0.284|||t-test, 2 sided|||||0.284|0.088|0.0002
70877557|NCT03194698|141239224|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
70957651|NCT01874431|141418971|OTHER||Least squares mean difference|-0.786||||0.5454|TWO_SIDED|95.0|-3.337|1.765|||t-test, 2 sided|||||1.765|-3.337|0.5454
70957652|NCT01874431|141418971|OTHER||Least squares mean difference|-1.61||||0.2186|TWO_SIDED|95.0|-4.177|0.957|||t-test, 2 sided|||||0.957|-4.177|0.2186
70957653|NCT01874431|141418971|OTHER||Least squares mean difference|-0.918||||0.4859|TWO_SIDED|95.0|-3.503|1.667|||t-test, 2 sided|||||1.667|-3.503|0.4859
70957654|NCT01874431|141418971|OTHER||Least squares mean difference|-1.8||||0.1677|TWO_SIDED|95.0|-4.358|0.759|||t-test, 2 sided|||||0.759|-4.358|0.1677
70957655|NCT01874431|141418971|OTHER||Least squares mean difference|-2.613||||0.0462|TWO_SIDED|95.0|-5.183|-0.044|||t-test, 2 sided|||||-0.044|-5.183|0.0462
70957656|NCT01874431|141418971|OTHER||Least squares mean difference|-2.228||||0.0705|TWO_SIDED|95.0|-4.643|0.187|||t-test, 2 sided|||||0.187|-4.643|0.0705
70957657|NCT01874431|141418971|OTHER||Least squares mean difference|-2.446||||0.048|TWO_SIDED|95.0|-4.869|-0.022|||t-test, 2 sided|||||-0.022|-4.869|0.048
70957658|NCT01874431|141418972|OTHER||Least square mean difference|-2.863||||0.0757|TWO_SIDED|95.0|-6.022|0.297|||t-test, 2 sided|||||0.297|-6.022|0.0757
70957659|NCT01874431|141418972|OTHER||Least square mean difference|-0.643||||0.6941|TWO_SIDED|95.0|-3.851|2.565|||t-test, 2 sided|||||2.565|-3.851|0.6941
70957660|NCT01874431|141418972|OTHER||Least square mean difference|-1.976||||0.2228|TWO_SIDED|95.0|-5.155|1.203|||t-test, 2 sided|||||1.203|-5.155|0.2228
70957661|NCT01874431|141418972|OTHER||Least square mean difference|-1.932||||0.2313|TWO_SIDED|95.0|-5.098|1.234|||t-test, 2 sided|||||1.234|-5.098|0.2313
70957662|NCT01874431|141418972|OTHER||Least square mean difference|-3.342||||0.0386|TWO_SIDED|95.0|-6.509|-0.176|||t-test, 2 sided|||||-0.176|-6.509|0.0386
70957663|NCT01874431|141418972|OTHER||Least square mean difference|-0.634||||0.677|TWO_SIDED|95.0|-3.624|2.355|||t-test, 2 sided|||||2.355|-3.624|0.677
70957664|NCT01874431|141418972|OTHER||Least square mean difference|-0.688||||0.6536|TWO_SIDED|95.0|-3.699|2.322|||t-test, 2 sided|||||2.322|-3.699|0.6536
70877558|NCT03194698|141239225|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
70957665|NCT01874431|141418973|OTHER||Least square mean difference|-3.044||||0.0816|TWO_SIDED|95.0|-6.471|0.383|||t-test, 2 sided|||||0.383|-6.471|0.0816
70957666|NCT01874431|141418973|OTHER||Least square mean difference|-0.537||||0.7625|TWO_SIDED|95.0|-4.027|2.953|||t-test, 2 sided|||||2.953|-4.027|0.7625
70957667|NCT01874431|141418973|OTHER||Least square mean difference|-1.301|||=|0.4603|TWO_SIDED|95.0|-4.759|2.157|||t-test, 2 sided|||||2.157|-4.759|= 0.4603
70957668|NCT01874431|141418973|OTHER||Least square mean difference|-1.574||||0.3678|TWO_SIDED|95.0|-5.004|1.855|||t-test, 2 sided|||||1.855|-5.004|0.3678
70957669|NCT01874431|141418973|OTHER||Least square mean difference|-1.727||||0.3279|TWO_SIDED|95.0|-5.191|1.736|||t-test, 2 sided|||||1.736|-5.191|0.3279
70957670|NCT01874431|141418973|OTHER||Least square mean difference|-1.682||||0.3102|TWO_SIDED|95.0|-4.935|1.57|||t-test, 2 sided|||||1.57|-4.935|0.3102
70957671|NCT01874431|141418973|OTHER||Least square mean difference|-2.511||||0.1317|TWO_SIDED|95.0|-5.778|0.755|||t-test, 2 sided|||||0.755|-5.778|0.1317
70957672|NCT00757588|141418975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.089|<|0.0001|TWO_SIDED|95.0|-0.59|-0.24||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment + metformin use|||-0.24|-0.59|<0.0001
70957673|NCT00757588|141418976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3829.8|STANDARD_ERROR_OF_MEAN|1165.99||0.0011|TWO_SIDED|95.0|-6122.4|-1537.1||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment + metformin use|||-1537.1|-6122.4|0.0011
70957674|NCT00757588|141418977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.0|STANDARD_ERROR_OF_MEAN|7.24||0.0016|TWO_SIDED|95.0|-37.2|-8.7||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment + metformin use|||-8.7|-37.2|0.0016
70957675|NCT00757588|141418978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.02|STANDARD_ERROR_OF_MEAN|4.732||0.3958|TWO_SIDED|95.0|-13.32|5.28||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment + metformin use|||5.28|-13.32|0.3958
70957676|NCT00757588|141418980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|95.0|-5.6|-1.1||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment + metformin use|||-1.1|-5.6|
70957677|NCT05398237|141418989|OTHER|A self-contained, subject-level permutation test for changes of all analytes in a pathway, assuming all analyte levels increasing after SSL exposure.||||||0.0122||||||Change in pathway from baseline to 1 hour post-SSL. Threshold for p-value of each test is 0.05/4=0.0125 based on Bonferroni adjustment for four tests, with two time points and two pathways (TLR4 and TOPK/PRPK).|Permutation test|The self-contained, subject-level permutation test comparing the pre- and post-SSL levels of all analytes in the pathway.||This is a single-arm study||||0.0122
70957678|NCT05398237|141418989|OTHER|A self-contained, subject-level permutation test for changes of all analytes in a pathway, assuming all analyte levels increasing after SSL exposure.||||||0.009||||||Change in pathway from baseline to 24 hours post-SSL. Threshold for p-value of each test is 0.05/4=0.0125 based on Bonferroni adjustment for four tests, with two time points and two pathways (TLR4 and TOPK/PRPK)|Permutation test|The self-contained, subject-level permutation test comparing the pre- and post-SSL levels of all analytes in the pathway.||This is a single-arm study.||||0.009
70957679|NCT05398237|141418990|OTHER|A self-contained, subject-level permutation test for changes of all analytes in a pathway, assuming all analyte levels increasing after SSL exposure.||||||0.0063||||||Change in pathway from baseline to 1 hour post-SSL. Threshold for p-value of each test is 0.05/4=0.0125 based on Bonferroni adjustment for four tests, with two time points and two pathways (TLR4 and TOPK/PRPK)|Permutation test|The self-contained, subject-level permutation test comparing the pre- and post-SSL levels of all analytes in the pathway.||This is a single-arm study||||0.0063
70877559|NCT02625259|141239232|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.36|||||TWO_SIDED|90.0|1.0|1.83||||||Analysis of variance was performed for calculating 90 percent (%) confidence intervals (CIs) for the ratios of log-transformed geometric mean Cmax of TAK-117 tablet versus capsule dosage form.||1.83|1.00|
70877560|NCT02625259|141239232|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.2|||||TWO_SIDED|90.0|0.86|1.67||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean Cmax of TAK-117 tablet dosage form with food versus without food.||1.67|0.86|
70877561|NCT02625259|141239232|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.03|||||TWO_SIDED|90.0|0.02|0.07||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean Cmax of TAK-117 tablet dosage form with lansoprazole versus a single dose of TAK-117 alone.||0.07|0.02|
70877562|NCT02625259|141239234|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.47|||||TWO_SIDED|90.0|0.98|2.18||||||Analysis of variance was performed for calculating 90 % CIs for the ratios of log-transformed geometric mean AUClast of TAK-117 tablet versus capsule dosage form.||2.18|0.98|
70877563|NCT02625259|141239234|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.76|||||TWO_SIDED|90.0|1.11|2.78||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean AUClast of TAK-117 tablet dosage form with food versus without food.||2.78|1.11|
70877564|NCT02625259|141239234|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.02|||||TWO_SIDED|90.0|0.01|0.04||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean AUClast of TAK-117 tablet dosage form with lansoprazole versus a single dose of TAK-117 alone.||0.04|0.01|
70877565|NCT02625259|141239235|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.53|||||TWO_SIDED|90.0|0.93|2.51||||||Analysis of variance was performed for calculating 90 % CIs for the ratios of log-transformed geometric mean AUC∞ of TAK-117 tablet versus capsule dosage form.||2.51|0.93|
70877566|NCT02625259|141239235|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.5|||||TWO_SIDED|90.0|1.0|2.25||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean AUC∞ of TAK-117 tablet dosage form with food versus without food.||2.25|1.00|
70877567|NCT02625259|141239235|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.08|||||TWO_SIDED|90.0|0.03|0.18||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean AUC∞ of TAK-117 tablet dosage form with lansoprazole versus a single dose of TAK-117 alone.||0.18|0.03|
70877568|NCT00665847|141239242|SUPERIORITY_OR_OTHER||Proportion|52.5|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|42.7|62.2|||||The standard error for a proportion was calculated as the square root of the variance divided by the number of patients. The variance for a proportion is equal to p\*(1-p), with p being the proportion.|||62.2|42.7|
70877569|NCT03143569|141239252|OTHER|||||||0.45|||||||Fisher Exact|||||||.45
70957680|NCT05398237|141418990|OTHER|A self-contained, subject-level permutation test for changes of all analytes in a pathway, assuming all analyte levels increasing after SSL exposure.||||||0.0056||||||Change in pathway from baseline to 24 hours post-SSL. Threshold for p-value of each test is 0.05/4=0.0125 based on Bonferroni adjustment for four tests, with two time points and two pathways (TLR4 and TOPK/PRPK)|Permutation test|The self-contained, subject-level permutation test comparing the pre- and post-SSL levels of all analytes in the pathway.||This is a single-arm study.||||0.0056
70877570|NCT03143569|141239253|OTHER|||||||1|||||||Fisher Exact|||||||1.0
70877571|NCT03143569|141239254|OTHER|||||||1|||||||Fisher Exact|||||||1.0
70877572|NCT03143569|141239255|OTHER|||||||1|||||||Fisher Exact|||||||1.0
70877573|NCT03143569|141239256|OTHER|||||||0.018|||||||Chi-squared|||||||.018
70877574|NCT01031069|141239401|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% confidence interval (CI) for the ratio of GMTs (Cervarix over Gardasil) being above (\>) 0.5 for HPV-16 type.|Adjusted GMT ratio|2.95|||||TWO_SIDED|95.0|1.92|4.52||||||Adjusted GMT ratios for anti-HPV-16 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV+/Cervarix Group) was non-inferior to that of Gardasil vaccine (HIV+/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-16, measured by Pseudovirion-based neutralization assay (PBNA) one month after the administration of the third dose of vaccine in HIV+ subjects.|Primary objectives were to be assessed sequentially: firstly, non-inferiority for both HPV-16 and HPV-18, and then, superiority for HPV-18 followed by superiority for HPV-16.|4.52|1.92|
70877575|NCT01031069|141239401|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% confidence interval (CI) for the ratio of GMTs (Cervarix over Gardasil) being above (\>) 0.5 for HPV-18 type.|Adjusted GMT ratio|7.83|||||TWO_SIDED|95.0|4.84|12.66||||||Adjusted GMT ratios for anti-HPV-18 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV+/Cervarix Group) was non-inferior to that of Gardasil vaccine (HIV+/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-18, measured by Pseudovirion-based neutralization assay (PBNA) one month after the administration of the third dose of vaccine in HIV+ subjects.|Primary objectives were to be assessed sequentially: firstly, non-inferiority for both HPV-16 and HPV-18, and then, superiority for HPV-18 followed by superiority for HPV-16.|12.66|4.84|
70957681|NCT01383499|141419002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.023||0.0002|TWO_SIDED|95.0|0.042|0.132||First step of closed testing procedure, where the active treatments are compared to placebo. If this statistical test significant at the 0.05 alpha level then proceed to comparison of the next lower dose to placebo.|Mixed model repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as random effect.||Tio R5 minus Placebo||0.132|0.042|0.0002
70957682|NCT01383499|141419002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.059|0.149||Second step of closed testing procedure. If this statistical test significant at the 0.05 alpha level then proceed to comparison of the next lower dose to placebo.|Mixed model repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as random effect.||Tio R2.5 minus Placebo||0.149|0.059|<.0001
70957683|NCT01383499|141419002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|0.023||0.0011|TWO_SIDED|95.0|0.03|0.12|||Mixed model repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R1.25 minus Placebo||0.120|0.030|0.0011
70957684|NCT01383499|141419002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.023|||TWO_SIDED|95.0|-0.034|0.057|||Mixed model repeated measures (MMRM)|||Tio R5 minus Tio R1.25||0.057|-0.034|
70957685|NCT01383499|141419002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.017|STANDARD_ERROR_OF_MEAN|0.023|||TWO_SIDED|95.0|-0.063|0.028|||Mixed model repeated measures (MMRM)|||Tio R5 minus Tio R2.5||0.028|-0.063|
70957686|NCT01383499|141419002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.029|STANDARD_ERROR_OF_MEAN|0.023|||TWO_SIDED|95.0|-0.016|0.074|||Mixed models repeated measures (MMRM)|||Tio R2.5 minus Tio R1.25||0.074|-0.016|
70877576|NCT01031069|141239402|SUPERIORITY|Superiority was defined as the lower limit of the 95% CI for the ratio of GMTs (Cervarix over Gardasil) being above 1 for HPV-18 type, with a statistically significant p-value.|Adjusted GMT ratio|7.44|||<|0.0001|TWO_SIDED|95.0|4.79|11.54|||ANOVA|ANOVA model on the log10 transformation of the titers for HIV+ subjects and including the vaccine group as fixed effect.||Adjusted GMT ratios for anti-HPV-18 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV+/Cervarix Group) was superior to that of Gardasil vaccine (HIV+/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-18, measured by Pseudovirion-based neutralization assay (PBNA) in HIV+ subjects, assessed following a sequential approach.|Primary objectives were to be assessed sequentially: firstly, non-inferiority for both HPV-16 and HPV-18, and then, superiority for HPV-18 followed by superiority for HPV-16.|11.54|4.79|<0.0001
70877577|NCT01031069|141239402|SUPERIORITY|Superiority was defined as the lower limit of the 95% CI for the ratio of GMTs (Cervarix over Gardasil) being above 1 for HPV-16 type, with a statistically significant p-value.|Adjusted GMT ratio|2.74|||<|0.0001|TWO_SIDED|95.0|1.83|4.11|||ANOVA|ANOVA model on the log10 transformation of the titers for HIV+ subjects and including the vaccine group as fixed effect.||Adjusted GMT ratios for anti-HPV-16 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV+/Cervarix Group) was superior to that of Gardasil vaccine (HIV+/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-16, measured by Pseudovirion-based neutralization assay (PBNA) in HIV+ subjects, following a sequential approach.|Primary objectives were to be assessed sequentially: firstly, non-inferiority for both HPV-16 and HPV-18, and then, superiority for HPV-18 followed by superiority for HPV-16.|4.11|1.83|<0.0001
70877578|NCT01031069|141239419|SUPERIORITY|Superiority was defined as the lower limit of the 97.5% CI for the ratio of GMTs (Cervarix over Gardasil) for HPV-18 type being above 1, with a statistically significant p-value.|Adjusted GMT ratio|5.38|||<|0.0001|TWO_SIDED|97.5|3.2|9.06|||ANOVA|ANOVA model on the log10 transformation of the titers for HIV- subjects and including the vaccine group as fixed effect.||Adjusted GMT ratio for anti-HPV-18 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV-/Cervarix Group) was superior to that of Gardasil vaccine (HIV-/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-18, measured by Pseudovirion-based neutralization assay (PBNA) in HIV- subjects.||9.06|3.20|<0.0001
70877579|NCT01031069|141239419|SUPERIORITY|Superiority was defined as the lower limit of the 97.5% CI for the ratio of GMTs (Cervarix over Gardasil) for HPV-16 type being above 1, with a statistically significant p-value.|Adjusted GMT ratio|3.05|||<|0.0001|TWO_SIDED|97.5|1.84|5.06|||ANOVA|ANOVA model on the log10 transformation of the titers for HIV- subjects and including the vaccine group as fixed effect.||Adjusted GMT ratio for anti-HPV-16 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV-/Cervarix Group) was superior to that of Gardasil vaccine (HIV-/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-16, measured by Pseudovirion-based neutralization assay (PBNA) in HIV- subjects.||5.06|1.84|<0.0001
70877580|NCT01103284|141239434|SUPERIORITY_OR_OTHER|||||||0.33||||||The a priori threshold for statistical significance was 0.05|Mixed Models Analysis|The Mixed-Effect Model Repeated Measure (MMRM) was adjusted for the following baseline covariates: age, C-peptide, insulin dose by body weight and AUC||||||0.33
70877581|NCT01103284|141239435|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED|||||A priori threshold for statistical significance was 0.05|Mixed Models Analysis|The MMRM model was adjusted for the following covariates: age, Baseline C-peptide, Baseline insulin dose adjusted for body weight, and Baseline AUC.||||||0.68
70877582|NCT01103284|141239436|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED|||||The a priori threshold for statistical significance was 0.05|Mixed Models Analysis|The MMRM model was adjusted for the following covariates: age, Baseline C-peptide, Baseline insulin dose adjusted for body weight, and Baseline AUC||||||0.44
70877583|NCT01103284|141239438|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.38||||0.07|TWO_SIDED|95.0|-0.02|0.79||Standard multiple imputation was used to predict the number and timing of hypoglycemic events after discontinuing the study for subjects who did not remain in the study until Month 25.|negative binomial regression|||The number of hypoglycemia events during the study was analyzed using a negative binomial regression model, with number of events as the dependent variable, and treatment, age, baseline daily insulin dose, and baseline C-peptide as covariates. The log of duration in the study for each patient was used as an offset variable in the model.||0.79|-0.02|0.07
70877584|NCT02801942|141239439|OTHER||Mean Difference (Final Values)|2.31|STANDARD_ERROR_OF_MEAN|3.307|||TWO_SIDED|95.0|-4.59|9.21|||||The mean difference in circulating B lymphocytes (Healthy participants versus NOT1D participants) in blood has been presented.|||9.21|-4.59|
70877585|NCT02801942|141239439|OTHER||Mean Difference (Final Values)|3.54|STANDARD_ERROR_OF_MEAN|2.398|||TWO_SIDED|95.0|-1.46|8.54|||||The mean difference in Classical B Lymphocytes (Healthy participants versus NOT1D participants) in blood has been presented.|||8.54|-1.46|
70877586|NCT02801942|141239439|OTHER||Mean Difference (Final Values)|-3.01|STANDARD_ERROR_OF_MEAN|1.854|||TWO_SIDED|95.0|-6.87|0.86|||||The mean difference in Double Negative B Lymphocytes (Healthy participants versus NOT1D participants) in blood has been presented.|||0.86|-6.87|
70877587|NCT02801942|141239439|OTHER||Mean Difference (Final Values)|-2.51|STANDARD_ERROR_OF_MEAN|4.482||||95.0|-11.86|6.84|||||The mean difference in Naive B Lymphocytes (Healthy participants versus NOT1D participants) in blood has been presented.|||6.84|-11.86|
70957687|NCT03038438|141419028|OTHER|Single arm study with a hypothesis test comparing to performance goal|Proportion|88.0|||<|0.0001|ONE_SIDED|97.5|82.5||||Fisher Exact|||"The primary effectiveness endpoint, primary patency at 12 months, was tested against a PG of 75%. The null and alternative hypotheses tested appear below:~H0: π ≤ PG vs. HA: π \> PG where π is the primary patency rate at 12 months in the study population and PG is the performance goal of 75%. The primary effectiveness objective will be met if the lower limit of the 97.5% one-sided confidence interval is above 75%."|||82.5|<0.0001
70877588|NCT02801942|141239440|OTHER||Mean Difference (Final Values)|3.38|STANDARD_ERROR_OF_MEAN|2.658|||TWO_SIDED|95.0|-2.22|8.98|||||The mean difference in Circulating B Lymphocytes (Healthy participants versus NOT1D participants) in iLN has been presented.|||8.98|-2.22|
70877589|NCT02801942|141239440|OTHER||Mean Difference (Final Values)|8.59|STANDARD_ERROR_OF_MEAN|5.833|||TWO_SIDED|95.0|-3.72|20.91|||||The mean difference in Classical B Lymphocytes (Healthy participants versus NOT1D participants) in iLN has been presented.|||20.91|-3.72|
70877590|NCT02801942|141239440|OTHER||Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|2.347|||TWO_SIDED|95.0|-6.53|3.38|||||The mean difference in Double Negative B Lymphocytes (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.38|-6.53|
70877591|NCT02801942|141239440|OTHER||Mean Difference (Final Values)|-8.31|STANDARD_ERROR_OF_MEAN|5.221|||TWO_SIDED|95.0|-19.32|2.71|||||The mean difference in Naive B Lymphocytes (Healthy participants versus NOT1D participants) in iLN has been presented.|||2.71|-19.32|
70877592|NCT02801942|141239441|OTHER||Mean Difference (Final Values)|0.92|STANDARD_ERROR_OF_MEAN|0.873|||TWO_SIDED|95.0|-0.9|2.75|||||The mean difference in B-cells (Healthy participants versus NOT1D participants) in blood has been presented.|||2.75|-0.90|
70877593|NCT02801942|141239441|OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.063|||TWO_SIDED|95.0|-0.07|0.19|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.19|-0.07|
70877594|NCT02801942|141239441|OTHER||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|95.0|-3.41|2.84|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) in blood has been presented.|||2.84|-3.41|
70877595|NCT02801942|141239441|OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|95.0|-0.1|0.13|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) in blood has been presented.|||0.13|-0.10|
70877596|NCT02801942|141239441|OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.118|||TWO_SIDED|95.0|-0.19|0.31|||||The mean difference in Dendritic cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.31|-0.19|
70877597|NCT02801942|141239441|OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|1.482|||TWO_SIDED|95.0|-3.23|2.96|||||The mean difference in NK cells (Healthy participants versus NOT1D participants) in blood has been presented.|||2.96|-3.23|
70877598|NCT02801942|141239442|OTHER||Mean Difference (Final Values)|1.54|STANDARD_ERROR_OF_MEAN|2.231|||TWO_SIDED|95.0|-3.14|6.23|||||The mean difference in B-cells in (Healthy participants versus NOT1D participants) iLN has been presented.|||6.23|-3.14|
70877599|NCT02801942|141239442|OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.25|0.34|||||The mean difference in CD56bright sNK cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.34|-0.25|
70877600|NCT02801942|141239442|OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.253|||TWO_SIDED|95.0|-0.54|0.52|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.52|-0.54|
70877601|NCT02801942|141239442|OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.059|||TWO_SIDED|95.0|-0.15|0.1|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.10|-0.15|
70877602|NCT02801942|141239442|OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.128|||TWO_SIDED|95.0|-0.21|0.34|||||The mean difference in Dendritic cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.34|-0.21|
70877603|NCT02801942|141239442|OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.487|||TWO_SIDED|95.0|-1.1|0.96|||||The mean difference in NK cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.96|-1.10|
70877604|NCT02801942|141239443|OTHER||Mean Difference (Final Values)|1.03|STANDARD_ERROR_OF_MEAN|1.326|||TWO_SIDED|95.0|-1.73|3.8|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) in blood has been presented.|||3.80|-1.73|
70877605|NCT02801942|141239443|OTHER||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|2.324|||TWO_SIDED|95.0|-7.54|2.16|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) in blood has been presented.|||2.16|-7.54|
70957688|NCT03038438|141419029|OTHER|Single-arm study with a hypothesis test comparing to performance goal|Proportion|2.0|||<|0.0001|ONE_SIDED|97.5||5.0|||Fisher Exact|||"The primary safety endpoint, major adverse events at 30 days post-procedure, was tested against a performance goal of 12.5%. The null and alternative hypotheses tested appear below:~H0: P ≥ PG vs. HA: P \< PG where P is the primary safety endpoint at 30 days in the study population and PG is the performance goal.~The primary safety objective will be met if the upper limit of the 97.5% one-sided confidence interval is below 12.5%."||5.0||<0.0001
70957689|NCT02476279|141419087|NON_INFERIORITY|To declare noninferiority, the upper bound of the two-sided 95% CI for the risk difference in post-ERCP pancreatitis (indomethacin alone minus indomethacin plus stent) needed to be less than 5% in both the intention-to-treat and per protocol analysis populations.|Risk Difference (RD)|0.036|||||TWO_SIDED|95.0|0.006|0.066|||||These numbers are in the intention-to-treat analysis population. Risk difference in post-ERCP pancreatitis (PEP) is calculated as risk of PEP in indomethacin alone arm minus risk of PEP in indomethacin plus stent arm.|||0.066|0.006|
70957690|NCT02476279|141419087|NON_INFERIORITY|To declare noninferiority, the upper bound of the two-sided 95% CI for the risk difference in post-ERCP pancreatitis (indomethacin alone minus indomethacin plus stent) needed to be less than 5% in both the intention-to-treat and per protocol analysis populations.|Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.003|0.06|||||These numbers are in the per protocol analysis population. Risk difference in post-ERCP pancreatitis (PEP) is calculated as risk of PEP in indomethacin alone arm minus risk of PEP in indomethacin plus stent arm.|||0.060|-0.003|
70957691|NCT02476279|141419088|OTHER||Risk Difference (RD)|0.021|||||TWO_SIDED|95.0|-0.002|0.043|||||These numbers are in the intention-to-treat analysis population. Risk difference is calculated as risk of moderate-severe PEP in indomethacin alone arm minus risk of moderate-severe PEP in indomethacin plus stent arm.|||0.043|-0.002|
70957692|NCT02476279|141419088|OTHER||Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.004|0.044|||||These numbers are in the per protocol analysis population. Risk difference is calculated as risk of moderate-severe PEP in indomethacin alone arm minus risk of moderate-severe PEP in indomethacin plus stent arm.|||0.044|-0.004|
70957693|NCT00577473|141419093|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0455||||0.4411|TWO_SIDED|95.0|-7.01|16.11||4.8 g/day compared to 2.4 g/day|Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||16.11|-7.01|0.4411
70957694|NCT00577473|141419094|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.0331||||0.5677|TWO_SIDED|95.0|-14.67|8.04|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||8.04|-14.67|0.5677
70957695|NCT00577473|141419095|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.0445||||0.473|TWO_SIDED|95.0|-16.6|7.7|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||7.7|-16.6|0.4730
70957696|NCT00577473|141419096|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0339||||0.5761|TWO_SIDED|95.0|-8.48|15.26|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||15.26|-8.48|0.5761
70957697|NCT00577473|141419097|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0766||||0.215|TWO_SIDED|95.0|-4.41|19.74|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||19.74|-4.41|0.2150
70957698|NCT00577473|141419098|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0351||||0.5569|TWO_SIDED|95.0|-8.18|15.2|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||15.20|-8.18|0.5569
70957699|NCT00577473|141419099|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1091||||0.0769|TWO_SIDED|95.0|-1.1|22.91|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||22.91|-1.10|0.0769
70957700|NCT00577473|141419100|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1139||||0.0551|TWO_SIDED|95.0|-0.13|22.92|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||22.92|-0.13|0.0551
70957701|NCT00577473|141419101|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0738||||0.2306|TWO_SIDED|95.0|-4.66|19.43|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||19.43|-4.66|0.2306
70957702|NCT00577473|141419102|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0652||||0.2931|TWO_SIDED|95.0|-5.6|18.64|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||18.64|-5.60|0.2931
70957703|NCT00577473|141419103|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0051||||0.9349|TWO_SIDED|95.0|-11.67|12.69|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||12.69|-11.67|0.9349
70957704|NCT00577473|141419104|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.065||||0.2583|TWO_SIDED|95.0|-4.72|17.73|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||17.73|-4.72|0.2583
70957705|NCT01502631|141419108|SUPERIORITY||Least Squares (LS) Mean|5.61|STANDARD_ERROR_OF_MEAN|4.497||0.2182|TWO_SIDED|90.0|-1.93|13.14|||Mixed Model Repeated Measures (MMRM)|||Difference (SUN13837 - Placebo) at Week 2||13.14|-1.93|0.2182
70957706|NCT01502631|141419108|SUPERIORITY||Least Squares (LS) Mean|6.87|STANDARD_ERROR_OF_MEAN|5.583||0.226|TWO_SIDED|90.0|-2.54|16.27|||Mixed Model Repeated Measures (MMRM)|||Difference (SUN13837 - Placebo) at Week 4||16.27|-2.54|0.2260
70957707|NCT01502631|141419108|SUPERIORITY||Least Squares (LS) Mean|3.03|STANDARD_ERROR_OF_MEAN|6.023||0.6184|TWO_SIDED|90.0|-7.15|13.21|||Mixed Model Repeated Measures (MMRM)|||Difference (SUN13837 - Placebo) at Week 8||13.21|-7.15|0.6184
70957708|NCT01502631|141419108|SUPERIORITY||Least Squares (LS) Mean|4.54|STANDARD_ERROR_OF_MEAN|6.524||0.4912|TWO_SIDED|90.0|-6.48|15.56|||Mixed Model Repeated Measures (MMRM)|||Difference (SUN13837 - Placebo) at Week 16||15.56|-6.48|0.4912
70957709|NCT02084056|141419115|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|103.68|STANDARD_ERROR_OF_MEAN|1.018|<|0.0001|TWO_SIDED|90.0|100.703|106.747|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)|||106.747|100.703|<0.0001
70957710|NCT02084056|141419115|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|101.63|STANDARD_ERROR_OF_MEAN|1.047||0.0003|TWO_SIDED|90.0|93.721|110.202|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 2000 fed/ L+M 2000 fed)|||110.202|93.721|0.0003
70957711|NCT02084056|141419116|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|114.58|STANDARD_ERROR_OF_MEAN|1.038||0.0113|TWO_SIDED|90.0|107.687|121.908|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)|||121.908|107.687|0.0113
70957712|NCT02084056|141419116|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|98.28|STANDARD_ERROR_OF_MEAN|1.075||0.0064|TWO_SIDED|90.0|86.543|111.609|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 2000 fed/ L+M 2000 fed)|||111.609|86.543|0.0064
70877606|NCT02801942|141239443|OTHER||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.738|||TWO_SIDED|95.0|-1.12|1.95|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) in blood has been presented.|||1.95|-1.12|
70877607|NCT02801942|141239444|OTHER||Mean Difference (Final Values)|6.84|STANDARD_ERROR_OF_MEAN|5.564|||TWO_SIDED|95.0|-4.92|18.6|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||18.60|-4.92|
70877608|NCT02801942|141239444|OTHER||Mean Difference (Final Values)|-7.89|STANDARD_ERROR_OF_MEAN|7.918|||TWO_SIDED|95.0|-24.77|9.0|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) in iLN has been presented.|||9.00|-24.77|
70877609|NCT02801942|141239444|OTHER||Mean Difference (Final Values)|-1.46|STANDARD_ERROR_OF_MEAN|2.379|||TWO_SIDED|95.0|-6.66|3.73|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.73|-6.66|
70877610|NCT02801942|141239445|OTHER||Mean Difference (Final Values)|1.33|STANDARD_ERROR_OF_MEAN|4.558|||TWO_SIDED|95.0|-8.17|10.84|||||The mean difference in myeloid dendritic cells (Healthy participants versus NOT1D participants) in blood has been presented.|||10.84|-8.17|
70877611|NCT02801942|141239445|OTHER||Mean Difference (Final Values)|-1.85|STANDARD_ERROR_OF_MEAN|4.658|||TWO_SIDED|95.0|-11.57|7.86|||||The mean difference in plasmacytoid dendritic cells (Healthy participants versus NOT1D participants) in blood has been presented.|||7.86|-11.57|
70877612|NCT02801942|141239446|OTHER||Mean Difference (Final Values)|12.23|STANDARD_ERROR_OF_MEAN|5.658|||TWO_SIDED|95.0|0.38|24.09|||||The mean difference in myeloid dendritic cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||24.09|0.38|
70877613|NCT02801942|141239446|OTHER||Mean Difference (Final Values)|-10.87|STANDARD_ERROR_OF_MEAN|6.961|||TWO_SIDED|95.0|-25.52|3.78|||||The mean difference in plasmacytoid dendritic cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.78|-25.52|
70877614|NCT02801942|141239449|OTHER||Mean Difference (Final Values)|1.79|STANDARD_ERROR_OF_MEAN|6.329|||TWO_SIDED|95.0|-11.41|14.99|||||The mean difference in CD45RA+ Effector Memory CD8 (Healthy participants versus NOT1D participants) in blood has been presented.|||14.99|-11.41|
70877615|NCT02801942|141239449|OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|2.28|||TWO_SIDED|95.0|-4.6|4.91|||||The mean difference in Central Memory CD8 (Healthy participants versus NOT1D participants) in blood has been presented.|||4.91|-4.60|
70877616|NCT02801942|141239449|OTHER||Mean Difference (Final Values)|4.38|STANDARD_ERROR_OF_MEAN|3.297|||TWO_SIDED|95.0|-2.5|11.26|||||The mean difference in Effector Memory CD8 (Healthy participants versus NOT1D participants) in blood has been presented.|||11.26|-2.50|
70877617|NCT02801942|141239449|OTHER||Mean Difference (Final Values)|-6.06|STANDARD_ERROR_OF_MEAN|5.729|||TWO_SIDED|95.0|-18.01|5.89|||||The mean difference in Naive CD8 (Healthy participants versus NOT1D participants) in blood has been presented.|||5.89|-18.01|
70877618|NCT02801942|141239449|OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.305|||TWO_SIDED|95.0|-0.67|0.6|||||The mean difference in Stem Cell Memory-like CD8 (Healthy participants versus NOT1D participants) in blood has been presented.|||0.60|-0.67|
70877619|NCT02801942|141239450|OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|3.133|||TWO_SIDED|95.0|-5.33|7.73|||||The mean difference in CD45RA+ Effector Memory CD8 (Healthy participants versus NOT1D participants) in iLN has been presented.|||7.73|-5.33|
70877620|NCT02801942|141239450|OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|1.466|||TWO_SIDED|95.0|-3.73|2.41|||||The mean difference in Central Memory CD8 (Healthy participants versus NOT1D participants) in iLN has been presented.|||2.41|-3.73|
70877621|NCT02801942|141239450|OTHER||Mean Difference (Final Values)|-1.85|STANDARD_ERROR_OF_MEAN|2.79|||TWO_SIDED|95.0|-7.67|3.96|||||The mean difference in Effector Memory CD8 (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.96|-7.67|
70877622|NCT02801942|141239450|OTHER||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|6.342|||TWO_SIDED|95.0|-12.54|13.87|||||The mean difference in Naive CD8 (Healthy participants versus NOT1D participants) in iLN has been presented.|||13.87|-12.54|
70877623|NCT02801942|141239450|OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.492|||TWO_SIDED|95.0|-1.71|0.36|||||The mean difference in Stem Cell Memory-like CD8 (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.36|-1.71|
70877624|NCT02801942|141239453|OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.236|||TWO_SIDED|95.0|-0.84|0.16|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.16|-0.84|
70877625|NCT02801942|141239454|OTHER||Mean Difference (Final Values)|-6.21|STANDARD_ERROR_OF_MEAN|4.362|||TWO_SIDED|95.0|-15.37|2.96|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||2.96|-15.37|
70877626|NCT02801942|141239455|OTHER||Mean Difference (Final Values)|1.03|STANDARD_ERROR_OF_MEAN|1.269|||TWO_SIDED|95.0|-1.61|3.68|||||The mean difference in CD45RA+ Effector Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||3.68|-1.61|
70877627|NCT02801942|141239455|OTHER||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|3.152|||TWO_SIDED|95.0|-8.12|5.03|||||The mean difference in Central Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||5.03|-8.12|
70877628|NCT02801942|141239455|OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|2.089|||TWO_SIDED|95.0|-4.59|4.13|||||The mean difference in Effector Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||4.13|-4.59|
70957713|NCT02084056|141419117|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|96.45|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|91.23|101.97|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)|||101.97|91.23|<0.0001
70957714|NCT02084056|141419117|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|97.75|STANDARD_ERROR_OF_MEAN|1.04||0.0002|TWO_SIDED|90.0|90.47|105.63|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 2000 fed/ L+M 2000 fed)|||105.63|90.47|0.0002
70957715|NCT02084056|141419118|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|97.96|STANDARD_ERROR_OF_MEAN|1.038|<|0.0001|TWO_SIDED|90.0|92.046|104.257|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)|||104.257|92.046|<0.0001
70957716|NCT02084056|141419118|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|105.85|STANDARD_ERROR_OF_MEAN|1.053||0.003|TWO_SIDED|90.0|96.705|115.861|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 2000 fed/ L+M 2000 fed)|||115.861|96.705|0.0030
70957717|NCT02084056|141419119|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|103.48|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|98.426|108.79|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)|||108.790|98.426|<0.0001
70957718|NCT02084056|141419119|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|101.35|STANDARD_ERROR_OF_MEAN|1.062||0.0019|TWO_SIDED|90.0|91.13|112.708|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 2000 fed/ L+M 2000 fed)|||112.708|91.130|0.0019
70957719|NCT02084056|141419120|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|95.49|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|TWO_SIDED|90.0|89.73|101.62|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)|||101.62|89.73|<0.0001
70957720|NCT02084056|141419120|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|98.19|STANDARD_ERROR_OF_MEAN|1.05||0.0002|TWO_SIDED|90.0|90.73|106.27|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 2000 fed/ L+M 2000 fed)|||106.27|90.73|0.0002
70957721|NCT00395460|141419160|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was performed by means of a Confidence Interval (CI) approach: noninferiority of Gadavist was assumed if the one-sided 95% CI for pGadavist-pMagnevist was lying entirely to the right of the value -delta, where p is the estimated change in CNR and with pre-defined non-inferiority margin delta of 15% (=6.52 or 15% of 43.467).|Mean Difference (Final Values)|6.939|STANDARD_DEVIATION|38.83|||ONE_SIDED|95.0|-3.897||||non-inferiority||||||-3.897|
70957722|NCT00190749|141419281|SUPERIORITY_OR_OTHER|||||||0.226||95.0||||P-value for change to last observation|t-test, 2 sided|||||||0.226
70957723|NCT00190749|141419281|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-value is change to last observation|t-test, 2 sided|||||||0.030
70957724|NCT00190749|141419281|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||P-value for change to last observation.|ANCOVA|||||||0.204
70957725|NCT00190749|141419282|SUPERIORITY_OR_OTHER|||||||0.184||95.0|||||Pearson's correlation coefficient|||||||0.184
70957726|NCT00190749|141419282|SUPERIORITY_OR_OTHER|||||||0.295||95.0|||||Pearson's correlation coefficient|||||||0.295
70957727|NCT00190749|141419283|SUPERIORITY_OR_OTHER|||||||0.256||95.0|||||Pearson's correlation coefficient|||||||0.256
70957728|NCT00190749|141419283|SUPERIORITY_OR_OTHER|||||||0.277||95.0|||||Pearson's correlation coefficient|||||||0.277
70957729|NCT00190749|141419284|SUPERIORITY_OR_OTHER|||||||0.766||95.0|||||Pearson's correlation coefficient|||||||0.766
70957730|NCT00190749|141419284|SUPERIORITY_OR_OTHER|||||||0.622||95.0|||||Pearson's correlation coefficient|||||||0.622
70957731|NCT00190749|141419285|SUPERIORITY_OR_OTHER|||||||0.829||95.0|||||Pearson's correlation coefficient|||||||0.829
70957732|NCT00190749|141419285|SUPERIORITY_OR_OTHER|||||||0.714||95.0|||||Pearson's correlation coefficient|||||||0.714
70957733|NCT00190749|141419286|SUPERIORITY_OR_OTHER|||||||0.672||95.0|||||Pearson's correlation coefficient|||||||0.672
70957734|NCT00190749|141419286|SUPERIORITY_OR_OTHER|||||||0.191||95.0|||||Pearson's correlation coefficient|||||||0.191
70877629|NCT02801942|141239455|OTHER||Mean Difference (Final Values)|0.92|STANDARD_ERROR_OF_MEAN|3.835|||TWO_SIDED|95.0|-7.08|8.92|||||The mean difference in Naive Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||8.92|-7.08|
70877630|NCT02801942|141239455|OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.145|||TWO_SIDED|95.0|-0.4|0.21|||||The mean difference in Stem Cell Memory-like Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.21|-0.40|
70877631|NCT02801942|141239456|OTHER||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.236||||95.0|-0.23|0.75|||||The mean difference in CD45RA+ Effector Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.75|-0.23|
70877632|NCT02801942|141239456|OTHER||Mean Difference (Final Values)|-1.95|STANDARD_ERROR_OF_MEAN|3.943|||TWO_SIDED|95.0|-10.2|6.29|||||The mean difference in Central Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||6.29|-10.20|
70877633|NCT02801942|141239456|OTHER||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|3.621|||TWO_SIDED|95.0|-5.38|9.69|||||The mean difference in Effector Memory Conv T cells(Healthy participants versus NOT1D participants) in iLN has been presented.|||9.69|-5.38|
70877634|NCT02801942|141239456|OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|4.629|||TWO_SIDED|95.0|-10.47|8.86|||||The mean difference in Naive Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||8.86|-10.47|
70877635|NCT02801942|141239456|OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.268|||TWO_SIDED|95.0|-0.77|0.34|||||The mean difference in Stem cell Memory-like Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.34|-0.77|
70877636|NCT02801942|141239457|OTHER||Mean Difference (Final Values)|-5.09|STANDARD_ERROR_OF_MEAN|2.556|||TWO_SIDED|95.0|-10.42|0.25|||||The mean difference in TFH cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.25|-10.42|
70877637|NCT02801942|141239457|OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.15|0.07|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.07|-0.15|
70877638|NCT02801942|141239457|OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|1.428|||TWO_SIDED|95.0|-3.08|2.88|||||The mean difference in TH17 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||2.88|-3.08|
70877639|NCT02801942|141239457|OTHER||Mean Difference (Final Values)|2.09|STANDARD_ERROR_OF_MEAN|4.294|||TWO_SIDED|95.0|-6.87|11.05|||||The mean difference in TH1 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||11.05|-6.87|
70877640|NCT02801942|141239457|OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|2.382|||TWO_SIDED|95.0|-4.94|5.0|||||The mean difference in TH1 TH17 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||5.00|-4.94|
70877641|NCT02801942|141239457|OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|1.112|||TWO_SIDED|95.0|-2.31|2.32|||||The mean difference in TH1 TH17 TH2 T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||2.32|-2.31|
70877642|NCT02801942|141239457|OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|1.026|||TWO_SIDED|95.0|-2.73|1.55|||||The mean difference in TH1 TH2 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.55|-2.73|
70877643|NCT02801942|141239457|OTHER||Mean Difference (Final Values)|1.57|STANDARD_ERROR_OF_MEAN|1.474|||TWO_SIDED|95.0|-1.51|4.64|||||The mean difference in TH2 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||4.64|-1.51|
70877644|NCT02801942|141239457|OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.504|||TWO_SIDED|95.0|-1.05|1.05|||||The mean difference in TH22 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.05|-1.05|
70877645|NCT02801942|141239458|OTHER||Mean Difference (Final Values)|1.54|STANDARD_ERROR_OF_MEAN|3.607|||TWO_SIDED|95.0|-5.99|9.07|||||The mean difference in TFH cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||9.07|-5.99|
70877646|NCT02801942|141239458|OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.855|||TWO_SIDED|95.0|-2.43|1.18|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||1.18|-2.43|
70877647|NCT02801942|141239458|OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|1.391|||TWO_SIDED|95.0|-2.49|3.31|||||The mean difference in TH17 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.31|-2.49|
70877648|NCT02801942|141239458|OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|2.824|||TWO_SIDED|95.0|-9.39|2.39|||||The mean difference in TH1 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||2.39|-9.39|
70957735|NCT00190749|141419287|SUPERIORITY_OR_OTHER|||||||0.994||95.0|||||Pearson's correlation coefficient|||||||0.994
70877649|NCT02801942|141239458|OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.738|||TWO_SIDED|95.0|-1.29|1.78|||||The mean difference in TH1 TH17 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||1.78|-1.29|
70877650|NCT02801942|141239458|OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.544|||TWO_SIDED|95.0|-0.73|1.54|||||The mean difference in TH1 TH17 TH2 T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||1.54|-0.73|
70877651|NCT02801942|141239458|OTHER||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|1.246|||TWO_SIDED|95.0|-2.12|3.07|||||The mean difference in TH1 TH2 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.07|-2.12|
70877652|NCT02801942|141239458|OTHER||Mean Difference (Final Values)|3.05|STANDARD_ERROR_OF_MEAN|2.641|||TWO_SIDED|95.0|-2.45|8.55|||||The mean difference in TH2 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||8.55|-2.45|
70877653|NCT02801942|141239458|OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.448|||TWO_SIDED|95.0|-0.92|0.96|||||The mean difference in TH22 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.96|-0.92|
70877654|NCT02801942|141239459|OTHER||Mean Difference (Final Values)|-4.83|STANDARD_ERROR_OF_MEAN|2.82|||TWO_SIDED|95.0|-10.71|1.05|||||The mean difference in TFH cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.05|-10.71|
70957736|NCT00190749|141419287|SUPERIORITY_OR_OTHER|||||||0.456||95.0|||||Pearson's correlation coefficient|||||||0.456
70957737|NCT00190749|141419288|SUPERIORITY_OR_OTHER|||||||0.454||95.0|||||Pearson's correlation coefficient|||||||0.454
70957738|NCT00190749|141419288|SUPERIORITY_OR_OTHER|||||||0.974||95.0|||||Pearson's correlation coefficient|||||||0.974
70877655|NCT02801942|141239459|OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.953|||TWO_SIDED|95.0|-2.82|1.16|||||The mean difference in TH1 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.16|-2.82|
70877656|NCT02801942|141239459|OTHER||Mean Difference (Final Values)|-2.88|STANDARD_ERROR_OF_MEAN|1.536||||95.0|-6.08|0.33|||||The mean difference in TH1 TH17 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.33|-6.08|
70877657|NCT02801942|141239459|OTHER||Mean Difference (Final Values)|1.81|STANDARD_ERROR_OF_MEAN|0.963|||TWO_SIDED|95.0|-0.2|3.81|||||The mean difference in TH1 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||3.81|-0.20|
70877658|NCT02801942|141239459|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|1.289|||TWO_SIDED|95.0|-2.99|2.39|||||The mean difference in TH17 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||2.39|-2.99|
70877659|NCT02801942|141239459|OTHER||Mean Difference (Final Values)|3.38|STANDARD_ERROR_OF_MEAN|1.907|||TWO_SIDED|95.0|-0.59|7.36|||||The mean difference in TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||7.36|-0.59|
70877660|NCT02801942|141239459|OTHER||Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|1.413|||TWO_SIDED|95.0|-4.11|1.78|||||The mean difference in TH22 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.78|-4.11|
70877661|NCT02801942|141239460|OTHER||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|2.918|||TWO_SIDED|95.0|-5.6|6.63|||||The mean difference in TFH cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||6.63|-5.60|
70877662|NCT02801942|141239460|OTHER||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|1.842|||TWO_SIDED|95.0|-7.93|-0.26|||||The mean difference in TH1 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||-0.26|-7.93|
70877663|NCT02801942|141239460|OTHER||Mean Difference (Final Values)|-1.55|STANDARD_ERROR_OF_MEAN|1.209|||TWO_SIDED|95.0|-4.34|1.24|||||The mean difference in TH1 TH17 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||1.24|-4.34|
70877664|NCT02801942|141239460|OTHER||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|1.725|||TWO_SIDED|95.0|-4.51|2.77|||||The mean difference in TH1 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||2.77|-4.51|
70877665|NCT02801942|141239460|OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|2.193|||TWO_SIDED|95.0|-5.02|4.09|||||The mean difference in TH17 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||4.09|-5.02|
70877666|NCT02801942|141239460|OTHER||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|3.405|||TWO_SIDED|95.0|-6.52|7.68|||||The mean difference in TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||7.68|-6.52|
70877667|NCT02801942|141239460|OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.811|||TWO_SIDED|95.0|-2.21|1.4|||||The mean difference in TH22 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||1.40|-2.21|
70877668|NCT02801942|141239461|OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.601|||TWO_SIDED|95.0|-0.86|1.65|||||The mean difference in Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.65|-0.86|
70877669|NCT02801942|141239462|OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.929|||TWO_SIDED|95.0|-2.18|1.7|||||The mean difference in Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||1.70|-2.18|
70877670|NCT02801942|141239463|OTHER||Mean Difference (Final Values)|0.95|STANDARD_ERROR_OF_MEAN|0.443|||TWO_SIDED|95.0|0.02|1.87|||||The mean difference in CD69+ CD8 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.87|0.02|
70877671|NCT02801942|141239463|OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.58|||TWO_SIDED|95.0|-2.04|0.38|||||The mean difference in Ki67+ CD8 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.38|-2.04|
70877672|NCT02801942|141239464|OTHER||Mean Difference (Final Values)|-2.77|STANDARD_ERROR_OF_MEAN|4.299|||TWO_SIDED|95.0|-11.81|6.27|||||The mean difference in CD69+ CD8 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||6.27|-11.81|
70877673|NCT02801942|141239464|OTHER||Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|1.051|||TWO_SIDED|95.0|-0.04|4.44|||||The mean difference in Ki67+ CD8 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||4.44|-0.04|
70877674|NCT02801942|141239465|OTHER||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|2.214|||TWO_SIDED|95.0|-5.91|3.32|||||The mean difference in CD15s+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||3.32|-5.91|
70877675|NCT02801942|141239465|OTHER||Mean Difference (Final Values)|0.92|STANDARD_ERROR_OF_MEAN|0.308|||TWO_SIDED|95.0|0.28|1.57|||||The mean difference in CD69+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.57|0.28|
70877676|NCT02801942|141239465|OTHER||Mean Difference (Final Values)|4.21|STANDARD_ERROR_OF_MEAN|3.017|||TWO_SIDED|95.0|-2.08|10.51|||||The mean difference in Helios+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||10.51|-2.08|
70877677|NCT02801942|141239465|OTHER||Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.985|||TWO_SIDED|95.0|-3.03|1.08|||||The mean difference in Ki67+ T Reg cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.08|-3.03|
70957739|NCT00190749|141419289|SUPERIORITY_OR_OTHER|||||||0.249||95.0|||||Pearson's correlation coefficient|||||||0.249
70957740|NCT00190749|141419289|SUPERIORITY_OR_OTHER|||||||0.163||95.0|||||Pearson's correlation coefficient|||||||0.163
70957741|NCT00190749|141419290|SUPERIORITY_OR_OTHER|||||||0.201||95.0|||||Pearson's correlation coefficient|||||||0.201
70877678|NCT02801942|141239465|OTHER||Mean Difference (Final Values)|-4.86|STANDARD_ERROR_OF_MEAN|3.802|||TWO_SIDED|95.0|-12.8|3.07|||||The mean difference in Memory Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||3.07|-12.80|
70877679|NCT02801942|141239465|OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|4.733|||TWO_SIDED|95.0|-1.27|18.47|||||The mean difference in Resting Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||18.47|-1.27|
70877680|NCT02801942|141239466|OTHER||Mean Difference (Final Values)|6.53|STANDARD_ERROR_OF_MEAN|4.905||||95.0|-3.78|16.85|||||The mean difference in CD15s+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||16.85|-3.78|
70877681|NCT02801942|141239466|OTHER||Mean Difference (Final Values)|-8.54|STANDARD_ERROR_OF_MEAN|4.595|||TWO_SIDED|95.0|-18.17|1.1|||||The mean difference in CD69+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.10|-18.17|
70877682|NCT02801942|141239466|OTHER||Mean Difference (Final Values)|2.11|STANDARD_ERROR_OF_MEAN|2.519|||TWO_SIDED|95.0|-3.23|7.45|||||The mean difference in Helios+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||7.45|-3.23|
70877683|NCT02801942|141239466|OTHER||Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|2.02|||TWO_SIDED|95.0|-0.98|7.59|||||The mean difference in Ki67+ T Reg cells (Healthy participants versus NOT1D participants) in blood has been presented.|||7.59|-0.98|
70877684|NCT02801942|141239466|OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|4.026|||TWO_SIDED|95.0|-8.23|8.67|||||The mean difference in Memory Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||8.67|-8.23|
70877685|NCT02801942|141239466|OTHER||Mean Difference (Final Values)|8.31|STANDARD_ERROR_OF_MEAN|4.595|||TWO_SIDED|95.0|-1.32|17.95|||||The mean difference in Resting Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||17.95|-1.32|
70877686|NCT02801942|141239467|OTHER||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.601|||TWO_SIDED|95.0|-0.94|1.57|||||The mean difference in CD15s+ Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.57|-0.94|
70957742|NCT00190749|141419290|SUPERIORITY_OR_OTHER|||||||0.168||95.0|||||Pearson's correlation coefficient|||||||0.168
70957743|NCT00190749|141419291|SUPERIORITY_OR_OTHER|||||||0.793||95.0|||||Pearson's correlation coefficient|||||||0.793
70877687|NCT02801942|141239467|OTHER||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.306|||TWO_SIDED|95.0|0.0|1.28|||||The mean difference in CD69+ Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.28|0.00|
70877688|NCT02801942|141239467|OTHER||Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.345|||TWO_SIDED|95.0|-0.33|1.11|||||The mean difference in Helios+ Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.11|-0.33|
70877689|NCT02801942|141239467|OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.78|0.47|||||The mean difference in Ki67+ Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.47|-0.78|
70877690|NCT02801942|141239468|OTHER||Mean Difference (Final Values)|1.78|STANDARD_ERROR_OF_MEAN|0.989|||TWO_SIDED|95.0|-0.3|3.86|||||The mean difference in CD15s+ Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.86|-0.30|
70877691|NCT02801942|141239468|OTHER||Mean Difference (Final Values)|-2.55|STANDARD_ERROR_OF_MEAN|4.716|||TWO_SIDED|95.0|-12.45|7.35|||||The mean difference in CD69+ Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||7.35|-12.45|
70877692|NCT02801942|141239468|OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.957|||TWO_SIDED|95.0|-1.86|2.14|||||The mean difference in Helios+ Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||2.14|-1.86|
70877693|NCT02801942|141239468|OTHER||Mean Difference (Final Values)|2.74|STANDARD_ERROR_OF_MEAN|0.872|||TWO_SIDED|95.0|0.9|4.58|||||The mean difference in Ki67+ Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||4.58|0.90|
70957744|NCT00190749|141419291|SUPERIORITY_OR_OTHER|||||||0.777||95.0|||||Pearson's correlation coefficient|||||||0.777
70877694|NCT02801942|141239469|OTHER||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|1.344|||TWO_SIDED|95.0|-2.23|3.38|||||The mean difference in CD15s+ Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||3.38|-2.23|
70877695|NCT02801942|141239469|OTHER||Mean Difference (Final Values)|0.84|STANDARD_ERROR_OF_MEAN|0.351|||TWO_SIDED|95.0|0.1|1.57|||||The mean difference in CD69+ Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.57|0.10|
70877696|NCT02801942|141239469|OTHER||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.594|||TWO_SIDED|95.0|-0.41|2.07|||||The mean difference in Helios+ Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||2.07|-0.41|
70877697|NCT02801942|141239469|OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.589|||TWO_SIDED|95.0|-1.54|0.92|||||The mean difference in Ki67+ Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.92|-1.54|
70877698|NCT02801942|141239470|OTHER||Mean Difference (Final Values)|3.01|STANDARD_ERROR_OF_MEAN|1.728|||TWO_SIDED|95.0|-0.62|6.63|||||The mean difference in CD15s+ Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||6.63|-0.62|
70877699|NCT02801942|141239470|OTHER||Mean Difference (Final Values)|-2.06|STANDARD_ERROR_OF_MEAN|4.392|||TWO_SIDED|95.0|-11.33|7.21|||||The mean difference in CD69+ Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||7.21|-11.33|
70877700|NCT02801942|141239470|OTHER||Mean Difference (Final Values)|1.28|STANDARD_ERROR_OF_MEAN|2.042|||TWO_SIDED|95.0|-14.56|17.13|||||The mean difference in Helios+ Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||17.13|-14.56|
70877701|NCT02801942|141239470|OTHER||Mean Difference (Final Values)|2.14|STANDARD_ERROR_OF_MEAN|0.843|||TWO_SIDED|95.0|0.36|3.92|||||The mean difference in Ki67+ Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.92|0.36|
70957745|NCT00190749|141419292|SUPERIORITY_OR_OTHER|||||||0.815||95.0|||||Pearson's correlation coefficient|||||||0.815
70957746|NCT00190749|141419292|SUPERIORITY_OR_OTHER|||||||0.675||95.0|||||Pearson's correlation coefficient|||||||0.675
70957747|NCT00190749|141419293|SUPERIORITY_OR_OTHER|||||||0.393||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 1||||0.393
70877702|NCT02801942|141239471|OTHER||Mean Difference (Final Values)|2.29|STANDARD_ERROR_OF_MEAN|3.097|||TWO_SIDED|95.0|-4.24|8.83|||||The mean difference in Circulating B Lymphocytes (Healthy participants versus NOT1D participants) by FNA method has been presented.|||8.83|-4.24|
70877703|NCT02801942|141239471|OTHER||Mean Difference (Final Values)|4.46|STANDARD_ERROR_OF_MEAN|2.334|||TWO_SIDED|95.0|-0.47|9.39|||||The mean difference in Circulating B Lymphocytes (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||9.39|-0.47|
70877704|NCT02801942|141239471|OTHER||Mean Difference (Final Values)|11.54|STANDARD_ERROR_OF_MEAN|7.693|||TWO_SIDED|95.0|-5.24|28.32|||||The mean difference in Classical B Lymphocytes (Healthy participants versus NOT1D participants) by FNA method has been presented.|||28.32|-5.24|
70877705|NCT02801942|141239471|OTHER||Mean Difference (Final Values)|5.64|STANDARD_ERROR_OF_MEAN|6.0|||TWO_SIDED|95.0|-7.73|19.01|||||The mean difference in Classical B Lymphocytes (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||19.01|-7.73|
70877706|NCT02801942|141239471|OTHER||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|3.336|||TWO_SIDED|95.0|-8.46|5.71|||||The mean difference in Double Negative B Lymphocytes (Healthy participants versus NOT1D participants) by FNA method has been presented.|||5.71|-8.46|
70877707|NCT02801942|141239471|OTHER||Mean Difference (Final Values)|-1.78|STANDARD_ERROR_OF_MEAN|1.755|||TWO_SIDED|95.0|-5.54|1.98|||||The mean difference in Double Negative B Lymphocytes (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||1.98|-5.54|
70877708|NCT02801942|141239471|OTHER||Mean Difference (Final Values)|-8.3|STANDARD_ERROR_OF_MEAN|6.08|||TWO_SIDED|95.0|-21.58|4.98|||||The mean difference in Naive B Lymphocytes (Healthy participants versus NOT1D participants) by FNA method has been presented.|||4.98|-21.58|
70877709|NCT02801942|141239471|OTHER||Mean Difference (Final Values)|-8.31|STANDARD_ERROR_OF_MEAN|6.019|||TWO_SIDED|95.0|-21.49|4.87|||||The mean difference in Naive B Lymphocytes by (Healthy participants versus NOT1D participants) core biopsy method has been presented.|||4.87|-21.49|
70877710|NCT02801942|141239472|OTHER||Mean Difference (Final Values)|4.97|STANDARD_ERROR_OF_MEAN|2.538|||TWO_SIDED|95.0|-0.54|10.48|||||The mean difference in B-cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||10.48|-0.54|
70957748|NCT00190749|141419293|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 1||||0.033
70877711|NCT02801942|141239472|OTHER||Mean Difference (Final Values)|-1.88|STANDARD_ERROR_OF_MEAN|2.99|||TWO_SIDED|95.0|-8.37|4.61|||||The mean difference in B-cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||4.61|-8.37|
70877712|NCT02801942|141239472|OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.189|||TWO_SIDED|95.0|-0.26|0.54|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.54|-0.26|
70877713|NCT02801942|141239472|OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.147|||TWO_SIDED|95.0|-0.37|0.27|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.27|-0.37|
70877714|NCT02801942|141239472|OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.402|||TWO_SIDED|95.0|-1.27|0.49|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.49|-1.27|
70877715|NCT02801942|141239472|OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.312|||TWO_SIDED|95.0|-0.33|1.07|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||1.07|-0.33|
70877716|NCT02801942|141239472|OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.068|||TWO_SIDED|95.0|-0.16|0.13|||||The mean difference in CD56lo CD16- by (Healthy participants versus NOT1D participants) FNA method has been presented.|||0.13|-0.16|
70877717|NCT02801942|141239472|OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.068|||TWO_SIDED|95.0|-0.17|0.12|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.12|-0.17|
70877718|NCT02801942|141239472|OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.114|||TWO_SIDED|95.0|-0.03|0.47|||||The mean difference in Dendritic cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.47|-0.03|
70877719|NCT02801942|141239472|OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.221|||TWO_SIDED|95.0|-0.59|0.4|||||The mean difference in Dendritic cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.40|-0.59|
70877720|NCT02801942|141239472|OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.766|||TWO_SIDED|95.0|-1.72|1.6|||||The mean difference in NK cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||1.60|-1.72|
70877721|NCT02801942|141239472|OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.417|||TWO_SIDED|95.0|-0.99|0.82|||||The mean difference in NK cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.82|-0.99|
70877722|NCT02801942|141239473|OTHER||Mean Difference (Final Values)|13.72|STANDARD_ERROR_OF_MEAN|7.475|||TWO_SIDED|95.0|-2.72|30.15|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||30.15|-2.72|
70877723|NCT02801942|141239473|OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|7.566|||TWO_SIDED|95.0|-16.85|16.78|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||16.78|-16.85|
70877724|NCT02801942|141239473|OTHER||Mean Difference (Final Values)|-20.03|STANDARD_ERROR_OF_MEAN|8.586|||TWO_SIDED|95.0|-38.98|-1.08|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) by FNA method has been presented.|||-1.08|-38.98|
70877725|NCT02801942|141239473|OTHER||Mean Difference (Final Values)|4.25|STANDARD_ERROR_OF_MEAN|12.739|||TWO_SIDED|95.0|-24.14|32.65|||||The mean difference in CD56lo CD16+ by (Healthy participants versus NOT1D participants) core biopsy method has been presented.|||32.65|-24.14|
70877726|NCT02801942|141239473|OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|2.429|||TWO_SIDED|95.0|-5.54|5.26|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) by FNA method has been presented.|||5.26|-5.54|
70877727|NCT02801942|141239473|OTHER||Mean Difference (Final Values)|-2.79|STANDARD_ERROR_OF_MEAN|4.148|||TWO_SIDED|95.0|-12.31|6.73|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||6.73|-12.31|
70877728|NCT02801942|141239474|OTHER||Mean Difference (Final Values)|8.25|STANDARD_ERROR_OF_MEAN|7.673|||TWO_SIDED|95.0|-8.58|25.08|||||The mean difference in Myeloid Dendritic cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||25.08|-8.58|
70877729|NCT02801942|141239474|OTHER||Mean Difference (Final Values)|16.22|STANDARD_ERROR_OF_MEAN|6.189|||TWO_SIDED|95.0|3.17|29.26|||||The mean difference in Myeloid Dendritic cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||29.26|3.17|
70877730|NCT02801942|141239474|OTHER||Mean Difference (Final Values)|-7.89|STANDARD_ERROR_OF_MEAN|10.509|||TWO_SIDED|95.0|-31.03|15.25|||||The mean difference in Plasmacytoid Dendritic cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||15.25|-31.03|
70877731|NCT02801942|141239474|OTHER||Mean Difference (Final Values)|-13.85|STANDARD_ERROR_OF_MEAN|5.781|||TWO_SIDED|95.0|-26.04|-1.66|||||The mean difference in (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||-1.66|-26.04|
70877732|NCT02801942|141239476|OTHER||Mean Difference (Final Values)|-1.62|STANDARD_ERROR_OF_MEAN|3.561|||TWO_SIDED|95.0|-9.05|5.82|||||The mean difference in CD45RA+ Effector Memory CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||5.82|-9.05|
70957749|NCT00190749|141419293|SUPERIORITY_OR_OTHER|||||||0.392||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 2||||0.392
70877733|NCT02801942|141239476|OTHER||Mean Difference (Final Values)|4.01|STANDARD_ERROR_OF_MEAN|3.418|||TWO_SIDED|95.0|-3.13|11.16|||||The mean difference in CD45RA+ Effector Memory CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||11.16|-3.13|
70877734|NCT02801942|141239476|OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|1.428|||TWO_SIDED|95.0|-3.14|2.82|||||The mean difference in Central Memory CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||2.82|-3.14|
70877735|NCT02801942|141239476|OTHER||Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|1.851|||TWO_SIDED|95.0|-5.03|2.71|||||The mean difference in Central Memory CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||2.71|-5.03|
70877736|NCT02801942|141239476|OTHER||Mean Difference (Final Values)|-2.11|STANDARD_ERROR_OF_MEAN|3.132|||TWO_SIDED|95.0|-8.65|4.43|||||The mean difference in Effector Memory CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||4.43|-8.65|
70877737|NCT02801942|141239476|OTHER||Mean Difference (Final Values)|-1.59|STANDARD_ERROR_OF_MEAN|3.071|||TWO_SIDED|95.0|-8.0|4.81|||||The mean difference in Effector Memory CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||4.81|-8.00|
70877738|NCT02801942|141239476|OTHER||Mean Difference (Final Values)|3.51|STANDARD_ERROR_OF_MEAN|6.594|||TWO_SIDED|95.0|-10.21|17.24|||||The mean difference in Naive CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||17.24|-10.21|
70877739|NCT02801942|141239476|OTHER||Mean Difference (Final Values)|-2.18|STANDARD_ERROR_OF_MEAN|7.155|||TWO_SIDED|95.0|-17.1|12.74|||||The mean difference in Naive CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||12.74|-17.10|
70877740|NCT02801942|141239476|OTHER||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.708|||TWO_SIDED|95.0|-2.42|0.58|||||The mean difference in Stem Cell Memory-like CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.58|-2.42|
70877741|NCT02801942|141239476|OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.372|||TWO_SIDED|95.0|-1.19|0.35|||||The mean difference in Stem Cell Memory-like CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.35|-1.19|
70877742|NCT02801942|141239478|OTHER||Mean Difference (Final Values)|-5.39|STANDARD_ERROR_OF_MEAN|2.545|||TWO_SIDED|95.0|-11.56|0.78|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.78|-11.56|
70877743|NCT02801942|141239478|OTHER||Mean Difference (Final Values)|-7.03|STANDARD_ERROR_OF_MEAN|7.114|||TWO_SIDED|95.0|-22.22|8.16|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) by core biopsy FNA method has been presented.|||8.16|-22.22|
70877744|NCT02801942|141239479|OTHER||Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.358|||TWO_SIDED|95.0|-0.36|1.14|||||The mean difference in CD45RA+ Effector Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||1.14|-0.36|
70957750|NCT00190749|141419293|SUPERIORITY_OR_OTHER|||||||0.129||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 2||||0.129
70877745|NCT02801942|141239479|OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.184|||TWO_SIDED|95.0|-0.25|0.52|||||The mean difference in CD45RA+ Effector Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.52|-0.25|
70957751|NCT00190749|141419293|SUPERIORITY_OR_OTHER|||||||0.956||95.0|||||Pearson's correlation coefficient|||Change in Eating Bahavior Item 3||||0.956
70877746|NCT02801942|141239479|OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|4.22|||TWO_SIDED|95.0|-9.02|8.64|||||The mean difference in Central Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||8.64|-9.02|
70877747|NCT02801942|141239479|OTHER||Mean Difference (Final Values)|-3.72|STANDARD_ERROR_OF_MEAN|4.223|||TWO_SIDED|95.0|-12.57|5.13|||||The mean difference in Central Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||5.13|-12.57|
70957752|NCT00190749|141419293|SUPERIORITY_OR_OTHER|||||||0.846||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 3||||0.846
70877748|NCT02801942|141239479|OTHER||Mean Difference (Final Values)|2.25|STANDARD_ERROR_OF_MEAN|4.034|||TWO_SIDED|95.0|-6.16|10.66|||||The mean difference in Effector Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||10.66|-6.16|
70877749|NCT02801942|141239479|OTHER||Mean Difference (Final Values)|2.06|STANDARD_ERROR_OF_MEAN|3.994|||TWO_SIDED|95.0|-6.27|10.39|||||The mean difference in Effector Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||10.39|-6.27|
70957753|NCT00190749|141419293|SUPERIORITY_OR_OTHER|||||||0.675||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 4||||0.675
70957754|NCT00190749|141419293|SUPERIORITY_OR_OTHER|||||||0.306||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 4||||0.306
70877750|NCT02801942|141239479|OTHER||Mean Difference (Final Values)|-2.09|STANDARD_ERROR_OF_MEAN|5.727|||TWO_SIDED|95.0|-14.09|9.92|||||The mean difference in Naive Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||9.92|-14.09|
70877751|NCT02801942|141239479|OTHER||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|4.976|||TWO_SIDED|95.0|-9.91|10.87|||||The mean difference in Naive Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||10.87|-9.91|
70877752|NCT02801942|141239479|OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.314|||TWO_SIDED|95.0|-0.67|0.65|||||The mean difference in Stem Cell Memory-like Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.65|-0.67|
70877753|NCT02801942|141239479|OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.325|||TWO_SIDED|95.0|-1.1|0.26|||||The mean difference in Stem Cell Memory-like Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.26|-1.10|
70877754|NCT02801942|141239480|OTHER||Mean Difference (Final Values)|7.0|STANDARD_ERROR_OF_MEAN|4.671|||TWO_SIDED|95.0|-2.8|16.81|||||The mean difference in TFH cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||16.81|-2.80|
70877755|NCT02801942|141239480|OTHER||Mean Difference (Final Values)|-3.93|STANDARD_ERROR_OF_MEAN|4.828|||TWO_SIDED|95.0|-14.02|6.17|||||The mean difference in TFH cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||6.17|-14.02|
70877756|NCT02801942|141239480|OTHER||Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|0.651|||TWO_SIDED|95.0|-2.69|0.16|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.16|-2.69|
70877757|NCT02801942|141239480|OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|1.507|||TWO_SIDED|95.0|-3.21|3.24|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||3.24|-3.21|
70877758|NCT02801942|141239480|OTHER||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|1.709|||TWO_SIDED|95.0|-2.78|4.33|||||The mean difference in TH17 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||4.33|-2.78|
70877759|NCT02801942|141239480|OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|1.339|||TWO_SIDED|95.0|-2.75|2.85|||||The mean difference in TH17 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||2.85|-2.75|
70877760|NCT02801942|141239480|OTHER||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|3.631|||TWO_SIDED|95.0|-8.56|6.63|||||The mean difference in TH1 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||6.63|-8.56|
70877761|NCT02801942|141239480|OTHER||Mean Difference (Final Values)|-6.03|STANDARD_ERROR_OF_MEAN|2.708|||TWO_SIDED|95.0|-11.69|-0.38|||||The mean difference in TH1 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||-0.38|-11.69|
70877762|NCT02801942|141239480|OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.889|||TWO_SIDED|95.0|-1.98|1.78|||||The mean difference in TH1 TH17 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||1.78|-1.98|
70877763|NCT02801942|141239480|OTHER||Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.787|||TWO_SIDED|95.0|-1.07|2.24|||||The mean difference in TH1 TH17 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||2.24|-1.07|
70877764|NCT02801942|141239480|OTHER||Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.613|||TWO_SIDED|95.0|-0.85|1.72|||||The mean difference in TH1 TH17 TH2 T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||1.72|-0.85|
70877765|NCT02801942|141239480|OTHER||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.565|||TWO_SIDED|95.0|-0.8|1.56|||||The mean difference in TH1 TH17 TH2 T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||1.56|-0.80|
70877766|NCT02801942|141239480|OTHER||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|1.546|||TWO_SIDED|95.0|-2.71|3.76|||||The mean difference in TH1 TH2 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||3.76|-2.71|
70877767|NCT02801942|141239480|OTHER||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|1.61|||TWO_SIDED|95.0|-2.95|3.79|||||The mean difference in TH1 TH2 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||3.79|-2.95|
70877768|NCT02801942|141239480|OTHER||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|3.356|||TWO_SIDED|95.0|-4.84|9.14|||||The mean difference in TH2 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||9.14|-4.84|
70877769|NCT02801942|141239480|OTHER||Mean Difference (Final Values)|3.95|STANDARD_ERROR_OF_MEAN|2.481|||TWO_SIDED|95.0|-1.25|9.15|||||The mean difference in TH2 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||9.15|-1.25|
70877770|NCT02801942|141239480|OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.627|||TWO_SIDED|95.0|-1.28|1.38|||||The mean difference in TH22 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||1.38|-1.28|
70877771|NCT02801942|141239480|OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.438|||TWO_SIDED|95.0|-0.93|0.91|||||The mean difference in TH22 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.91|-0.93|
70877772|NCT02801942|141239481|OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|3.63|||TWO_SIDED|95.0|-7.4|8.0|||||The mean difference in TFH cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||8.00|-7.40|
70877773|NCT02801942|141239481|OTHER||Mean Difference (Final Values)|0.72|STANDARD_ERROR_OF_MEAN|2.694|||TWO_SIDED|95.0|-4.9|6.35|||||The mean difference in TFH cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||6.35|-4.90|
70877774|NCT02801942|141239481|OTHER||Mean Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|2.377|||TWO_SIDED|95.0|-9.89|0.08|||||The mean difference in TH1 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.08|-9.89|
70877775|NCT02801942|141239481|OTHER||Mean Difference (Final Values)|-3.29|STANDARD_ERROR_OF_MEAN|1.682|||TWO_SIDED|95.0|-6.82|0.24|||||The mean difference in TH1 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.24|-6.82|
70877776|NCT02801942|141239481|OTHER||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|1.036|||TWO_SIDED|95.0|-2.67|2.1|||||The mean difference in TH1 TH17 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||2.10|-2.67|
70877777|NCT02801942|141239481|OTHER||Mean Difference (Final Values)|-2.8|STANDARD_ERROR_OF_MEAN|1.929|||TWO_SIDED|95.0|-7.2|1.59|||||The mean difference in TH1 TH17 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||1.59|-7.20|
70877778|NCT02801942|141239481|OTHER||Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|2.117|||TWO_SIDED|95.0|-5.98|3.11|||||The mean difference in TH1 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||3.11|-5.98|
70877779|NCT02801942|141239481|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|2.047|||TWO_SIDED|95.0|-4.59|3.99|||||The mean difference in TH1 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||3.99|-4.59|
70877780|NCT02801942|141239481|OTHER||Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|2.645|||TWO_SIDED|95.0|-6.99|4.06|||||The mean difference in TH17 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||4.06|-6.99|
70877781|NCT02801942|141239481|OTHER||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|2.185|||TWO_SIDED|95.0|-4.05|5.11|||||The mean difference in TH17 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||5.11|-4.05|
70877782|NCT02801942|141239481|OTHER||Mean Difference (Final Values)|-2.25|STANDARD_ERROR_OF_MEAN|4.299|||TWO_SIDED|95.0|-11.23|6.73|||||The mean difference in TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||6.73|-11.23|
70877783|NCT02801942|141239481|OTHER||Mean Difference (Final Values)|3.42|STANDARD_ERROR_OF_MEAN|3.472|||TWO_SIDED|95.0|-3.84|10.67|||||The mean difference in TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||10.67|-3.84|
70877784|NCT02801942|141239481|OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|1.153|||TWO_SIDED|95.0|-3.3|2.0|||||The mean difference in TH22 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||2.00|-3.30|
70877785|NCT02801942|141239481|OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.869|||TWO_SIDED|95.0|-2.06|1.72|||||The mean difference in TH22 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||1.72|-2.06|
70877786|NCT02801942|141239482|OTHER||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|1.304|||TWO_SIDED|95.0|-2.27|3.19|||||The mean difference in Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||3.19|-2.27|
70877787|NCT02801942|141239482|OTHER||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|1.056|||TWO_SIDED|95.0|-3.24|1.36|||||The mean difference in Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||1.36|-3.24|
70877788|NCT02801942|141239483|OTHER||Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|5.069|||TWO_SIDED|95.0|-11.91|9.58|||||The mean difference in CD69+ CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||9.58|-11.91|
70877789|NCT02801942|141239483|OTHER||Mean Difference (Final Values)|-4.38|STANDARD_ERROR_OF_MEAN|5.301|||TWO_SIDED|95.0|-15.85|7.1|||||The mean difference in CD69+ CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||7.10|-15.85|
70877790|NCT02801942|141239483|OTHER||Mean Difference (Final Values)|1.48|STANDARD_ERROR_OF_MEAN|1.374|||TWO_SIDED|95.0|-1.62|4.59|||||The mean difference in Ki67+ CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||4.59|-1.62|
70877791|NCT02801942|141239483|OTHER||Mean Difference (Final Values)|2.91|STANDARD_ERROR_OF_MEAN|1.291|||TWO_SIDED|95.0|-0.05|5.88|||||The mean difference in Ki67+ CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||5.88|-0.05|
70877792|NCT02801942|141239484|OTHER||Mean Difference (Final Values)|4.86|STANDARD_ERROR_OF_MEAN|3.083|||TWO_SIDED|95.0|-1.6|11.31|||||The mean difference in CD15s+ Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||11.31|-1.60|
70877793|NCT02801942|141239484|OTHER||Mean Difference (Final Values)|8.21|STANDARD_ERROR_OF_MEAN|6.78|||TWO_SIDED|95.0|-6.15|22.57|||||The mean difference in CD15s+ Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||22.57|-6.15|
70877794|NCT02801942|141239484|OTHER||Mean Difference (Final Values)|-11.19|STANDARD_ERROR_OF_MEAN|5.812|||TWO_SIDED|95.0|-23.48|1.11|||||The mean difference in CD69+ Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||1.11|-23.48|
70877795|NCT02801942|141239484|OTHER||Mean Difference (Final Values)|-5.89|STANDARD_ERROR_OF_MEAN|3.855|||TWO_SIDED|95.0|-14.14|2.37|||||The mean difference in CD69+ Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||2.37|-14.14|
70877796|NCT02801942|141239484|OTHER||Mean Difference (Final Values)|1.65|STANDARD_ERROR_OF_MEAN|2.48|||TWO_SIDED|95.0|-3.54|6.84|||||The mean difference in Helios+ Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||6.84|-3.54|
70877797|NCT02801942|141239484|OTHER||Mean Difference (Final Values)|2.57|STANDARD_ERROR_OF_MEAN|2.937|||TWO_SIDED|95.0|-3.84|8.98|||||The mean difference in Helios+ Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||8.98|-3.84|
70877798|NCT02801942|141239484|OTHER||Mean Difference (Final Values)|3.22|STANDARD_ERROR_OF_MEAN|2.781|||TWO_SIDED|95.0|-2.67|9.12|||||The mean difference in Ki67+ T Reg cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||9.12|-2.67|
70877799|NCT02801942|141239484|OTHER||Mean Difference (Final Values)|3.38|STANDARD_ERROR_OF_MEAN|1.337|||TWO_SIDED|95.0|0.55|6.21|||||The mean difference in Ki67+ T Reg cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||6.21|0.55|
70877800|NCT02801942|141239484|OTHER||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|4.736|||TWO_SIDED|95.0|-11.49|8.58|||||The mean difference in Memory Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||8.58|-11.49|
70877801|NCT02801942|141239484|OTHER||Mean Difference (Final Values)|1.88|STANDARD_ERROR_OF_MEAN|4.142|||TWO_SIDED|95.0|-6.81|10.58|||||The mean difference in Memory Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||10.58|-6.81|
70877802|NCT02801942|141239484|OTHER||Mean Difference (Final Values)|10.45|STANDARD_ERROR_OF_MEAN|5.79|||TWO_SIDED|95.0|-2.01|22.92|||||The mean difference in Resting Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||22.92|-2.01|
70877803|NCT02801942|141239484|OTHER||Mean Difference (Final Values)|6.17|STANDARD_ERROR_OF_MEAN|4.913|||TWO_SIDED|95.0|-4.24|16.59|||||The mean difference in Resting Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||16.59|-4.24|
70877804|NCT02801942|141239485|OTHER||Mean Difference (Final Values)|1.38|STANDARD_ERROR_OF_MEAN|0.696|||TWO_SIDED|95.0|-0.08|2.83|||||The mean difference in CD15s+ Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||2.83|-0.08|
70877805|NCT02801942|141239485|OTHER||Mean Difference (Final Values)|2.19|STANDARD_ERROR_OF_MEAN|1.324|||TWO_SIDED|95.0|-0.61|4.98|||||The mean difference in CD15s+ Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||4.98|-0.61|
70877806|NCT02801942|141239485|OTHER||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|6.389|||TWO_SIDED|95.0|-14.66|12.85|||||The mean difference in CD69+ Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||12.85|-14.66|
70877807|NCT02801942|141239485|OTHER||Mean Difference (Final Values)|-4.19|STANDARD_ERROR_OF_MEAN|4.862|||TWO_SIDED|95.0|-14.71|6.33|||||The mean difference in CD69+ Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||6.33|-14.71|
70877808|NCT02801942|141239485|OTHER||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|1.234|||TWO_SIDED|95.0|-2.73|2.47|||||The mean difference in Helios+ Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||2.47|-2.73|
70877809|NCT02801942|141239485|OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.859|||TWO_SIDED|95.0|-1.45|2.28|||||The mean difference in Helios+ Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||2.28|-1.45|
70877810|NCT02801942|141239485|OTHER||Mean Difference (Final Values)|3.21|STANDARD_ERROR_OF_MEAN|1.205|||TWO_SIDED|95.0|0.64|5.78|||||The mean difference in Ki67+ Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||5.78|0.64|
70877811|NCT02801942|141239485|OTHER||Mean Difference (Final Values)|2.27|STANDARD_ERROR_OF_MEAN|0.712|||TWO_SIDED|95.0|0.75|3.79|||||The mean difference in Ki67+ Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||3.79|0.75|
70877812|NCT02801942|141239486|OTHER||Mean Difference (Final Values)|3.27|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|95.0|0.4|6.15|||||The mean difference in CD15s+ Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||6.15|0.40|
70877813|NCT02801942|141239486|OTHER||Mean Difference (Final Values)|2.74|STANDARD_ERROR_OF_MEAN|2.109|||TWO_SIDED|95.0|-1.68|7.17|||||The mean difference in CD15s+ Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||7.17|-1.68|
70877814|NCT02801942|141239486|OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|6.712|||TWO_SIDED|95.0|-14.49|14.48|||||The mean difference in CD69+ Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||14.48|-14.49|
70877815|NCT02801942|141239486|OTHER||Mean Difference (Final Values)|-4.12|STANDARD_ERROR_OF_MEAN|3.947|||TWO_SIDED|95.0|-12.67|4.43|||||The mean difference in CD69+ Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||4.43|-12.67|
70877816|NCT02801942|141239486|OTHER||Mean Difference (Final Values)|1.33|STANDARD_ERROR_OF_MEAN|2.967|||TWO_SIDED|95.0|-5.48|8.13|||||The mean difference in Helios+ Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||8.13|-5.48|
70877817|NCT02801942|141239486|OTHER||Mean Difference (Final Values)|1.24|STANDARD_ERROR_OF_MEAN|2.287|||TWO_SIDED|95.0|-4.36|6.84|||||The mean difference in Helios+ Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||6.84|-4.36|
70877818|NCT02801942|141239486|OTHER||Mean Difference (Final Values)|2.69|STANDARD_ERROR_OF_MEAN|1.019|||TWO_SIDED|95.0|0.54|4.84|||||The mean difference in Ki67+ Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||4.84|0.54|
70877819|NCT02801942|141239486|OTHER||Mean Difference (Final Values)|1.58|STANDARD_ERROR_OF_MEAN|0.737|||TWO_SIDED|95.0|0.03|3.13|||||The mean difference in Ki67+ Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||3.13|0.03|
70877820|NCT02057198|141239506|SUPERIORITY||Slope|-0.15||||0.52|TWO_SIDED|95.0|-0.34|0.05||Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models.|Mixed Models Analysis|A mixed effects model was used to compare decay slopes for the reduction in log(CFUs)/day according to each treatment group||||0.05|-0.34|0.52
70877821|NCT02057198|141239506|SUPERIORITY||Slope|-0.17||||0.66|TWO_SIDED|95.0|-0.69|0.35||Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models.|Mixed Models Analysis|A mixed effects model was used to compare decay slopes for the reduction in log(CFUs)/day according to each treatment group||||0.35|-0.69|0.66
70877822|NCT02057198|141239507|SUPERIORITY||||||<|0.001|||||||Chi square (2 proportion test)|||||||<0.001
70877823|NCT02057198|141239507|SUPERIORITY|||||||0.01|||||||Chi square (2 proportion test)|||||||0.01
70877824|NCT02057198|141239508|SUPERIORITY|||||||0.99|||||||Chi square (2 proportion test)|||||||0.99
70877825|NCT02057198|141239508|SUPERIORITY|||||||0.52|||||||Chi square (2 proportion test)|||||||0.52
70957755|NCT00190749|141419293|SUPERIORITY_OR_OTHER|||||||0.468||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 5||||0.468
70957756|NCT00190749|141419293|SUPERIORITY_OR_OTHER|||||||0.739||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 5||||0.739
70957757|NCT00190749|141419293|SUPERIORITY_OR_OTHER|||||||0.404||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 6||||0.404
70957758|NCT00190749|141419293|SUPERIORITY_OR_OTHER|||||||0.711||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 6||||0.711
70957759|NCT00190749|141419293|SUPERIORITY_OR_OTHER|||||||0.281||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 7||||0.281
70957760|NCT00190749|141419293|SUPERIORITY_OR_OTHER|||||||0.805||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 7||||0.805
70957761|NCT00190749|141419293|SUPERIORITY_OR_OTHER|||||||0.844||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 8||||0.844
70957762|NCT00190749|141419293|SUPERIORITY_OR_OTHER|||||||0.359||95.0|||||Pearson's correlation coefficient|||Change in Eating Bahavior Item 8||||0.359
70957763|NCT00190749|141419293|SUPERIORITY_OR_OTHER|||||||0.642||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 9||||0.642
70957764|NCT00190749|141419293|SUPERIORITY_OR_OTHER|||||||0.043||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 9||||0.043
70957765|NCT00190749|141419294|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on Least Squares Mean (LSMean) change||||||<.001
70957766|NCT00190749|141419294|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.019
70957767|NCT00190749|141419294|SUPERIORITY_OR_OTHER|||||||0.065||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change =Baseline Treatment Pooled Investigator||||||0.065
70957768|NCT00190749|141419295|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|With group p-values are from t-tests on LSMean change||||||<.001
70957769|NCT00190749|141419295|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.013
70957770|NCT00190749|141419295|SUPERIORITY_OR_OTHER|||||||0.076||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change = Baseline Treatment Pooled Investigator||||||0.076
70957771|NCT00190749|141419296|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.007
70957772|NCT00190749|141419296|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.266
70957773|NCT00190749|141419296|SUPERIORITY_OR_OTHER|||||||0.239||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change = Baseline Treatment Pooled Investigator||||||0.239
70957774|NCT00190749|141419297|SUPERIORITY_OR_OTHER|||||||0.274||95.0|||||t-test, 2 sided|Within group p-vales are from t-tests on LSMean change||||||0.274
70957775|NCT00190749|141419297|SUPERIORITY_OR_OTHER|||||||0.105||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change.||||||0.105
70957776|NCT00190749|141419297|SUPERIORITY_OR_OTHER|||||||0.609||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change= Baseline Treatment Pooled Investigator||||||0.609
70957777|NCT00190749|141419298|SUPERIORITY_OR_OTHER|||||||0.406||95.0|||||t-test, 2 sided|With group p-values are from t-tests on LSMean change||||||0.406
70957778|NCT00190749|141419298|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.011
70957779|NCT00190749|141419298|SUPERIORITY_OR_OTHER|||||||0.076||95.0|||||ANCOVA|Overall group p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.076
70957780|NCT00190749|141419299|SUPERIORITY_OR_OTHER|||||||0.456||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.456
70957781|NCT00190749|141419299|SUPERIORITY_OR_OTHER|||||||0.712||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.712
70957782|NCT00190749|141419299|SUPERIORITY_OR_OTHER|||||||0.689||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change= Baseline Treatment Pooled Investigator||||||0.689
70957783|NCT00190749|141419300|SUPERIORITY_OR_OTHER|||||||0.111||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean||Total Score||||0.111
70957784|NCT00190749|141419300|SUPERIORITY_OR_OTHER|||||||0.159||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean changes||Total Score||||0.159
70957785|NCT00190749|141419300|SUPERIORITY_OR_OTHER|||||||0.951||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change =Baseline Treatment Pooled Investigator||Total Score||||0.951
70957786|NCT00190749|141419300|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Positive Subscale||||0.012
70957787|NCT00190749|141419300|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|With group p-values are from t-tests on LSMean||Positive subscale||||0.002
70957788|NCT00190749|141419300|SUPERIORITY_OR_OTHER|||||||0.467||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change =Baseline Treatment Pooled Investigator||Positive subscale||||0.467
70957789|NCT00190749|141419300|SUPERIORITY_OR_OTHER|||||||0.365||95.0|||||t-test, 2 sided|With group p-values are from t-tests on LSMean change||Negative subscale||||0.365
70957790|NCT00190749|141419300|SUPERIORITY_OR_OTHER|||||||0.846||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Negative subscale||||0.846
70877826|NCT02057198|141239509|SUPERIORITY||Slope|-0.43||||0.05|TWO_SIDED|95.0|-0.67|-0.19|||Mixed Models Analysis|A mixed effects model was used to compare decay slopes for the reduction in log(CFUs)/day according to each treatment group||Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models. Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models.||-0.19|-0.67|0.05
70957791|NCT00190749|141419300|SUPERIORITY_OR_OTHER|||||||0.559||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Negative subscale||||0.559
70957792|NCT00190749|141419300|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Anxiety-Depression subscale||||0.150
70957793|NCT00190749|141419300|SUPERIORITY_OR_OTHER|||||||0.612||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Anxiety-Depression subscale||||0.612
70957794|NCT00190749|141419300|SUPERIORITY_OR_OTHER|||||||0.475||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Anxiety-Depression subscale||||0.475
70877827|NCT02057198|141239509|SUPERIORITY||Slope|-0.85||||0.002|TWO_SIDED|95.0|-1.14|-0.57|||Mixed Models Analysis|A mixed effects model was used to compare decay slopes for the reduction in log(CFUs)/day according to each treatment group||Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models. Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models.||-0.57|-1.14|0.002
70877828|NCT02057198|141239511|SUPERIORITY|||||||0.48|||||||Chi square (two proportion test)|||||||0.48
70877829|NCT02057198|141239511|SUPERIORITY|||||||0.66|||||||Chi square (two proportion test)|||||||0.66
70877830|NCT01985581|141239512|SUPERIORITY_OR_OTHER||LS mean difference|-3.0||||0.0392|TWO_SIDED|95.0|-5.9|-0.2|||ANOVA|||||-0.2|-5.9|0.0392
70877831|NCT01985581|141239513|SUPERIORITY_OR_OTHER||LS mean difference|0.3||||0.894|TWO_SIDED|95.0|-4.0|4.6|||ANOVA|||||4.6|-4.0|0.894
70877832|NCT01985581|141239514|SUPERIORITY_OR_OTHER||LS mean difference|-6.2||||0.0001|TWO_SIDED|95.0|-9.1|-3.2|||ANOVA|||||-3.2|-9.1|0.0001
70877833|NCT01985581|141239516|SUPERIORITY_OR_OTHER||LS mean difference|0.3||||0.8706|TWO_SIDED|95.0|-3.2|3.7|||ANOVA|||||3.7|-3.2|0.8706
70877834|NCT03878745|141239520|SUPERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> 0, we can conclude in superiority.|Overall Mean|0.21|||||TWO_SIDED|95.0|0.07|0.35||||||||0.35|0.07|
70957795|NCT00190749|141419301|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Within group p-values are from t-tests on LSMean change|t-test, 2 sided|||||||.012
70877835|NCT03878745|141239521|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-1.6|1.6||||||||1.6|-1.6|
70877836|NCT03878745|141239522|OTHER||Mean Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-3.6|0.1||||||||0.1|-3.6|
70877837|NCT03878745|141239523|SUPERIORITY|A mixed effect model was used (fixed effects of PN, abdomen site, order of pair, order of PN within pair and random subject effect) to estimate average difference (BD Nano PN - Terumo PN) in delivery time and total injection time. A Box-Cox transformation might be used to normalize the data if necessary.|Median Difference (Final Values)|-0.5|||<|0.001|ONE_SIDED|95.0||-0.026|||Mixed Models Analysis|||||-0.026||<0.001
70877838|NCT03878745|141239524|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-1.2|1.2||||||||1.2|-1.2|
70877839|NCT01042236|141239531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.88||0.4907|TWO_SIDED|95.0|-1.18|2.41||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||2.41|-1.18|0.4907
70877840|NCT01042236|141239531|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.88||0.5944|TWO_SIDED|95.0|-2.27|1.32||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||1.32|-2.27|0.5944
70957796|NCT00190749|141419301|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.010
70957797|NCT00190749|141419301|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of square ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.760
70877841|NCT01042236|141239532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.94||0.987|TWO_SIDED|95.0|-1.91|1.94||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||1.94|-1.91|0.9870
70957798|NCT00190749|141419302|SUPERIORITY_OR_OTHER|||||||0.943||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.943
70957799|NCT00190749|141419302|SUPERIORITY_OR_OTHER|||||||0.763||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.763
70957800|NCT00190749|141419302|SUPERIORITY_OR_OTHER|||||||0.832||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.832
70957801|NCT00190749|141419303|SUPERIORITY_OR_OTHER|||||||0.623||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.623
70877842|NCT01042236|141239532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.94||0.4167|TWO_SIDED|95.0|-2.71|1.15||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||1.15|-2.71|0.4167
70877843|NCT01042236|141239533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.12||0.9403|TWO_SIDED|95.0|-0.24|0.26||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||0.26|-0.24|0.9403
70877844|NCT01042236|141239533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.12||0.1881|TWO_SIDED|95.0|-0.42|0.09||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||0.09|-0.42|0.1881
70877845|NCT01042236|141239534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.12||0.8602|TWO_SIDED|95.0|-0.26|0.22||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||0.22|-0.26|0.8602
70877846|NCT01042236|141239534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.12||0.1271|TWO_SIDED|95.0|-0.43|0.06||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||0.06|-0.43|0.1271
70877847|NCT00227903|141239557|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88||95.0||||Not corrected for multiple comparison|Mixed Models Analysis|2 degrees of freedom||We estimated that 110 people with 10% attrition would provide 80% power||||0.88
70877848|NCT00227903|141239558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||95.0|||||Fisher Exact|||||||0.08
70877849|NCT00227903|141239559|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88||95.0||||Not corrected for multiple comparison.|Mixed Models Analysis|2 degrees of freedom||We estimated that 110 people with 10% attrition would provide 80% power.||||0.88
70877850|NCT00227903|141239560|SUPERIORITY_OR_OTHER_LEGACY|||||||0.41||95.0|||||Fisher Exact|||||||0.41
70877851|NCT00227903|141239561|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.77||||0.79|TWO_SIDED|95.0|0.36|1.67|||Regression, Logistic|||||1.67|0.36|0.79
70877852|NCT00227903|141239562|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||0.79|TWO_SIDED|95.0|0.42|2.62|||Regression, Logistic|||||2.62|0.42|0.79
70877853|NCT00227903|141239563|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.96||||0.88|TWO_SIDED|95.0|0.34|2.72|||Regression, Logistic|||||2.72|0.34|0.88
70877854|NCT00227903|141239564|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.21||||0.88|TWO_SIDED|95.0|0.57|2.57|||Regression, Logistic|||||2.57|0.57|0.88
70877855|NCT00227903|141239565|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.77||||0.5|TWO_SIDED|95.0|0.32|1.84|||Regression, Logistic|||||1.84|0.32|0.50
70877856|NCT00227903|141239566|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Mixed Models Analysis|||||||0.10
70877857|NCT00227903|141239567|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Mixed Models Analysis|||||||0.10
70877858|NCT00227903|141239568|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Mixed Models Analysis|||||||0.10
70877859|NCT00227903|141239569|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Mixed Models Analysis|||||||0.10
70877860|NCT00227903|141239570|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.76||||0.5|TWO_SIDED|95.0|0.27|2.11|||Regression, Logistic|||||2.11|0.27|0.50
70877861|NCT00227903|141239571|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.18||||0.07|TWO_SIDED|95.0|0.44|3.14|||Regression, Logistic|||||3.14|0.44|0.07
70877862|NCT00227903|141239572|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.46||||0.07|TWO_SIDED|95.0|0.47|4.52|||Regression, Logistic|||||4.52|0.47|0.07
70877863|NCT00227903|141239573|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.28||||0.07|TWO_SIDED|95.0|0.08|1.02|||Regression, Logistic|||||1.02|0.08|0.07
70877864|NCT00227903|141239574|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.62||||0.07|TWO_SIDED|95.0|0.1|3.9|||Regression, Logistic|||||3.90|0.10|0.07
70877865|NCT00227903|141239575|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.15||||0.91|TWO_SIDED|95.0|0.32|4.2|||Regression, Logistic|||||4.20|0.32|0.91
70877866|NCT00227903|141239576|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.33||||0.91|TWO_SIDED|95.0|0.35|5.07|||Regression, Logistic|||||5.07|0.35|0.91
70877867|NCT00227903|141239577|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.85||||0.91|TWO_SIDED|95.0|0.14|5.23|||Regression, Logistic|||||5.23|0.14|0.91
70877868|NCT00227903|141239578|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.23||||0.91|TWO_SIDED|95.0|0.21|7.12|||Regression, Logistic|||||7.12|0.21|0.91
70877869|NCT00227903|141239579|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.28||||0.04|TWO_SIDED|95.0|0.46|3.55|||Regression, Logistic|||||3.55|0.46|.04
70877870|NCT00227903|141239580|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.21||||0.04|TWO_SIDED|95.0|0.35|4.17|||Regression, Logistic|||||4.17|0.35|0.04
70877871|NCT00227903|141239581|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.25||||0.04|TWO_SIDED|95.0|0.04|1.63|||Regression, Logistic|||||1.63|0.04|0.04
70877872|NCT00227903|141239582|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.4||||0.04|TWO_SIDED|95.0|0.04|3.74|||Regression, Logistic|||||3.74|0.04|0.04
70877873|NCT00227903|141239583|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0|||||Cochran-Mantel-Haenszel|||||||0.01
70877874|NCT00227903|141239584|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Chi-squared|||||||>0.05
70957802|NCT00190749|141419303|SUPERIORITY_OR_OTHER|||||||0.853||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.853
70957803|NCT00190749|141419303|SUPERIORITY_OR_OTHER|||||||0.591||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.591
70877875|NCT01172847|141239705|SUPERIORITY_OR_OTHER||mean exposure ratio|0.98|||||TWO_SIDED|90.0|0.91|1.05|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|Mean exposure ratio of oseltamivir||1.05|0.91|
70957804|NCT00190749|141419304|SUPERIORITY_OR_OTHER|||||||0.302||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.302
70877876|NCT01172847|141239705|SUPERIORITY_OR_OTHER||mean exposure ratio|0.98|||||TWO_SIDED|90.0|0.95|1.02|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|Mean exposure ratio of oseltamivir carboxylate||1.02|0.95|
70957805|NCT00190749|141419304|SUPERIORITY_OR_OTHER|||||||0.922||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.922
70957806|NCT00190749|141419304|SUPERIORITY_OR_OTHER|||||||0.479||95.0|||||ANCOVA|Overall group p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.479
70957807|NCT00190749|141419305|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 1||||0.004
70877877|NCT01172847|141239706|SUPERIORITY_OR_OTHER||mean exposure ratio|1.03|||||TWO_SIDED|90.0|1.0|1.06|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|Mean exposure ratio of rimantadine||1.06|1.00|
70877878|NCT01172847|141239707|SUPERIORITY_OR_OTHER||mean exposure ratio|0.86|||||TWO_SIDED|90.0|0.77|0.96|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|Mean exposure ratio of oseltamivir||0.96|0.77|
70877879|NCT01172847|141239707|SUPERIORITY_OR_OTHER||mean exposure ratio|0.98|||||TWO_SIDED|90.0|0.92|1.05|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|Mean exposure ratio of oseltamivir carboxylate||1.05|0.92|
70877880|NCT01172847|141239708|SUPERIORITY_OR_OTHER||mean exposure ratio|1.03|||||TWO_SIDED|90.0|0.99|1.06|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|mean exposure ratio of rimantadine||1.06|0.99|
70877881|NCT01163279|141239713|SUPERIORITY_OR_OTHER|||||||0.03||||||Statistical analysis applies to post intervention performance category|Chi-squared|||||||0.03
70877882|NCT01163279|141239713|SUPERIORITY_OR_OTHER|||||||0.32||||||Statistical analysis applies to post intervention satisfaction category|Chi-squared|||||||0.32
70877883|NCT01163279|141239713|SUPERIORITY_OR_OTHER|||||||0.54||||||Statistical analysis applies to 3-month follow up performance category|Chi-squared|||||||0.54
70877884|NCT01163279|141239713|SUPERIORITY_OR_OTHER|||||||0.26||||||Statistical analysis applies to 3-month follow up satisfaction category|Chi-squared|||||||0.26
70877885|NCT01163279|141239714|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA|||||||<0.05
70877886|NCT01163279|141239715|SUPERIORITY_OR_OTHER||||||>|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA|||||||>0.05
70877887|NCT01163279|141239716|SUPERIORITY_OR_OTHER||||||>|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA|||||||>0.05
70877888|NCT01163279|141239717|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA|||||||<0.05
70877889|NCT01163279|141239718|SUPERIORITY_OR_OTHER||||||<|0.1||||||Statistical analysis applies to immediately post intervention category|ANOVA|||||||<0.1
70877890|NCT01163279|141239718|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to 3 months post intervention category|ANOVA|||||||<0.05
70877891|NCT01163279|141239719|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to immediately post intervention category|ANOVA|||||||<0.05
70877892|NCT01163279|141239719|SUPERIORITY_OR_OTHER||||||>|0.05||||||Statistical analysis applies to 3 months post intervention category|ANOVA|||||||>0.05
70877893|NCT01163279|141239720|SUPERIORITY_OR_OTHER||||||<|0.1||||||Statistical analysis applies to immediately post intervention category|ANOVA|||||||<0.1
70877894|NCT01163279|141239720|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to 3 months post intervention category|ANOVA|||||||<0.05
70877895|NCT01163279|141239721|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA|||||||<0.05
70877896|NCT01163279|141239722|SUPERIORITY_OR_OTHER||||||>|0.05||||||Statistical analysis applies to immediately post intervention category|ANOVA|||||||>0.05
70877897|NCT01163279|141239722|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to 3 months post intervention category|ANOVA|||||||<0.05
70877898|NCT01163279|141239723|SUPERIORITY_OR_OTHER||||||>|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA|||||||>0.05
70877899|NCT02493608|141239731|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70877900|NCT02493608|141239732|OTHER|||||||0.218||||||POD 1|t-test, 2 sided|||||||0.218
70877901|NCT02493608|141239732|OTHER|||||||0.638||||||POD 2|t-test, 2 sided|||||||0.638
70877902|NCT02493608|141239733|OTHER|||||||0.113|||||||t-test, 2 sided|||||||0.113
70877903|NCT00665353|141239747|SUPERIORITY_OR_OTHER||proportion|0.158||||0.29|ONE_SIDED|90.0|0.059|||This is an unadjusted p-value. Statistical significance was defined a priori as 0.10.|Exact test of proportions|||The proportion of subjects responding was compared to a historical null rate of 0.10. The hypothesized response rate was 0.30.|||0.059|0.29
70877904|NCT00665353|141239750|SUPERIORITY_OR_OTHER||proportion|0.053||||0.42|ONE_SIDED|90.0|0.001|||This is an unadjusted p-value. Statistical significance was defined a priori as 0.10.|Exact test of proportions|||The proportion of subjects responding was compared to a historical null rate of 0.02. The hypothesized response rate was 0.15.|||0.001|0.42
70957808|NCT00190749|141419305|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 1||||0.001
70877905|NCT02632552|141239788|EQUIVALENCE|Using a pre-intervention rate of 18 for both intervention and control, and a post-control change of 1, assuming an alpha of 0.05, we have power (0.8) to detect a difference of differences in change in mean urgent care/ED utilization of 0.75 with a standard deviation equal to the control mean; however, the equivalence boundary did not apply because this is a pragmatic trial.|Incidence Rate Ratio|1.11|STANDARD_ERROR_OF_MEAN|0.15||0.45|TWO_SIDED|95.0|0.85|1.45|||Mixed Effects Negative Binomial Model|A segmented negative binomial regression model was used to estimate changes in ED/urgent care utilization between the intervention and control groups.||||1.45|0.85|0.45
70877906|NCT02632552|141239789|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for the Mean Difference|-1.8||||0.05|TWO_SIDED|95.0|-7.21|3.61|||Mixed Models Analysis|||||3.61|-7.21|0.05
70957809|NCT00190749|141419305|SUPERIORITY_OR_OTHER|||||||0.549||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares, ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 1||||0.549
70957810|NCT00190749|141419305|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 2||||0.011
70957811|NCT00190749|141419305|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 2||||0.009
70957812|NCT00190749|141419305|SUPERIORITY_OR_OTHER|||||||0.793||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 2||||0.793
70957813|NCT00190749|141419305|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 3||||0.045
70957814|NCT00190749|141419305|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 3||||0.027
70957815|NCT00190749|141419305|SUPERIORITY_OR_OTHER|||||||0.699||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 3||||0.699
70957816|NCT00190749|141419305|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 4||||0.002
70957817|NCT00190749|141419305|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||ITem 4||||0.019
70957818|NCT00190749|141419305|SUPERIORITY_OR_OTHER|||||||0.733||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 4||||0.733
70957819|NCT00190749|141419305|SUPERIORITY_OR_OTHER|||||||0.034||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 5||||0.034
70957820|NCT00190749|141419305|SUPERIORITY_OR_OTHER|||||||0.235||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 5||||0.235
70957821|NCT00190749|141419305|SUPERIORITY_OR_OTHER|||||||0.532||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 5||||0.532
70957822|NCT00190749|141419305|SUPERIORITY_OR_OTHER|||||||0.242||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 6||||0.242
70957823|NCT00190749|141419305|SUPERIORITY_OR_OTHER|||||||0.186||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 6||||0.186
70957824|NCT00190749|141419305|SUPERIORITY_OR_OTHER|||||||0.799||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 6||||0.799
70957825|NCT00190749|141419305|SUPERIORITY_OR_OTHER|||||||0.097||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 7||||0.097
70957826|NCT00190749|141419305|SUPERIORITY_OR_OTHER|||||||0.214||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 7||||0.214
70957827|NCT00190749|141419305|SUPERIORITY_OR_OTHER|||||||0.827||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 7||||0.827
70957828|NCT00190749|141419305|SUPERIORITY_OR_OTHER|||||||0.151||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 8||||0.151
70957829|NCT00190749|141419305|SUPERIORITY_OR_OTHER|||||||0.071||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 8||||0.071
70877907|NCT02632552|141239790|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for the Mean Difference|0.82|STANDARD_ERROR_OF_MEAN|0.38||0.03|TWO_SIDED|95.0|0.08|1.57|||Mixed Models Analysis|MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.||||1.57|0.08|0.03
70877908|NCT02632552|141239791|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.18||0.75|TWO_SIDED|95.0|-0.41|0.29|||Mixed Models Analysis|MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.||||0.29|-0.41|0.75
70877909|NCT02632552|141239792|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.74|TWO_SIDED|95.0|-0.5|0.7|||Mixed Models Analysis|MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.||||0.70|-0.50|0.74
70877910|NCT02632552|141239793|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.87||0.63|TWO_SIDED|95.0|-2.21|1.29|||Mixed Models Analysis|MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.||||1.29|-2.21|0.63
70877911|NCT02632552|141239794|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta of Mean Difference|1.54|STANDARD_ERROR_OF_MEAN|1.26||0.23|TWO_SIDED|95.0|-0.97|4.05|||Mixed Models Analysis|MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.||||4.05|-0.97|0.23
70877912|NCT02632552|141239795|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for the Mean Difference|-2.43|STANDARD_ERROR_OF_MEAN|2.8||0.38|TWO_SIDED|95.0|-7.95|3.1||MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.|Mixed Models Analysis|||||3.10|-7.95|0.38
70877913|NCT02632552|141239796|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for the Mean Difference|-2.79|STANDARD_ERROR_OF_MEAN|3.2||0.38|TWO_SIDED|95.0|-9.1|3.52|||Mixed Models Analysis|MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.||||3.52|-9.10|0.38
70877914|NCT00546637|141239797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.1959||95.0|-0.9|0.2||P-value was based on an ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (Net) = Least squares mean|The null hypothesis was that the mean change from Baseline in 24-hour micturition-related urgency was the same at Week 12 for the two treatment groups: fesoterodine + alpha-blocker vs. placebo + alpha-blocker. It was estimated that 900 randomized subjects would have 85% power to detect a mean difference of -0.93(SD = 4.15) between the 2 treatments on the primary endpoint,mean reduction of micturition-related urgency episodes/24hr from Baseline to Week 12,assuming a 10% non-evaluability rate.||0.2|-0.9|0.1959
70877915|NCT00546637|141239798|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.0621||95.0|-1.0|0.0||P-value was based on an ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|||0.0|-1.0|0.0621
70877916|NCT00546637|141239800|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0056||95.0|-0.8|-0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||-0.1|-0.8|0.0056
70877917|NCT00546637|141239800|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.009||95.0|-0.7|-0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||-0.1|-0.7|0.0090
70877918|NCT00546637|141239801|SUPERIORITY_OR_OTHER|||||||0.0012||95.0||||P-value was based on a ranked ANCOVA model with terms for country, treatment, and ranked baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|Ranked ANCOVA|Treatment comparisons were performed only if the corresponding numerical change from Baseline at the same visit was statistically significant.||Week 4||||0.0012
70957830|NCT00190749|141419305|SUPERIORITY_OR_OTHER|||||||0.629||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 8||||0.629
70877919|NCT00546637|141239801|SUPERIORITY_OR_OTHER|||||||0.0027||95.0||||P-value was based on a ranked ANCOVA model with terms for country, treatment, and ranked baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|Ranked ANCOVA|Treatment comparisons were performed only if the corresponding numerical change from Baseline at the same visit was statistically significant.||Week 12||||0.0027
70877920|NCT00546637|141239802|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1112||95.0|-0.2|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||0.0|-0.2|0.1112
70957831|NCT00190749|141419305|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 9||||0.036
70957832|NCT00190749|141419305|SUPERIORITY_OR_OTHER|||||||0.112||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 9||||0.112
70957833|NCT00190749|141419305|SUPERIORITY_OR_OTHER|||||||0.806||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 9||||0.806
70957834|NCT00190749|141419306|SUPERIORITY_OR_OTHER|||||||0.156||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.156
70957835|NCT00190749|141419306|SUPERIORITY_OR_OTHER|||||||0.829||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.829
70957836|NCT00190749|141419306|SUPERIORITY_OR_OTHER|||||||0.352||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.352
70957837|NCT00190749|141419307|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.740
70957838|NCT00190749|141419307|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||t-test, 2 sided|Within group p-values are frm t-tests on LSMean change||||||0.760
70957839|NCT00190749|141419307|SUPERIORITY_OR_OTHER|||||||0.997||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.997
70957840|NCT00190749|141419308|SUPERIORITY_OR_OTHER|||||||0.176||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.176
70957841|NCT00190749|141419308|SUPERIORITY_OR_OTHER|||||||0.237||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.237
70957842|NCT00190749|141419308|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.996
70957843|NCT00190749|141419309|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.027
70957844|NCT00190749|141419309|SUPERIORITY_OR_OTHER|||||||0.545||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.545
70957845|NCT00190749|141419309|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.024
70957846|NCT00190749|141419310|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||HDL particles, total||||0.009
70957847|NCT00190749|141419310|SUPERIORITY_OR_OTHER|||||||0.959||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||HDL particles, total||||0.959
70957848|NCT00190749|141419310|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline TReatment Pooled Investigator|ANCOVA|||HDL particles, total||||0.038
70957849|NCT00190749|141419310|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||IDL||||0.013
70957850|NCT00190749|141419310|SUPERIORITY_OR_OTHER|||||||0.928||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||IDL||||0.928
70957851|NCT00190749|141419310|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||IDL||||0.049
70957852|NCT00190749|141419310|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Medium small LDL||||0.009
70957853|NCT00190749|141419310|SUPERIORITY_OR_OTHER|||||||0.662||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Medium small LDL||||0.662
70957854|NCT00190749|141419310|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Medium small LDL||||0.12
70957855|NCT00190749|141419310|SUPERIORITY_OR_OTHER|||||||0.099||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Small LDL||||0.099
70957856|NCT00190749|141419310|SUPERIORITY_OR_OTHER|||||||0.304||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Small LDL||||0.304
70957857|NCT00190749|141419310|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Small LDL||||0.024
70957858|NCT00190749|141419310|SUPERIORITY_OR_OTHER|||||||0.176||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Very small LDL||||0.176
70957859|NCT00190749|141419310|SUPERIORITY_OR_OTHER|||||||0.246||95.0|||||t-test, 2 sided|Withn group p-values are from t-tests on LSMean change||Very small LDL||||0.246
70957860|NCT00190749|141419310|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator|ANCOVA|||Very small LDL||||0.033
70957861|NCT00190749|141419310|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||VLDL mean particle size||||<0.001
70957862|NCT00190749|141419310|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||VLDL mean particle size||||0.047
70957863|NCT00190749|141419310|SUPERIORITY_OR_OTHER|||||||0.221||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||VLDL mean particle size||||0.221
70957864|NCT01200589|141419311|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.89|1.49||||||||1.49|0.89|
70957865|NCT01090427|141419321|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
70957866|NCT01090427|141419321|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
70957867|NCT01090427|141419322|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
70957868|NCT01090427|141419322|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
70957869|NCT01090427|141419323|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] will be used as factors in the model.||||||0.003
70877921|NCT00546637|141239802|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.0855||95.0|-0.3|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.0|-0.3|0.0855
70877922|NCT00546637|141239804|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.3847||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was estimated using Hodges-Lehmann estimate of the location shift between the two groups.|Week 4||||0.3847
70877923|NCT00546637|141239804|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.4449||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was estimated using Hodges-Lehmann estimate of the location shift between the two groups.|Week 12||||0.4449
70877924|NCT00546637|141239806|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.33||||0.0062||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|Week 4||||0.0062
70877925|NCT00546637|141239806|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.0825||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|Week 12||||0.0825
70877926|NCT00546637|141239807|SUPERIORITY_OR_OTHER|||||||0.0025||95.0||||P-value for median was based on a ranked ANCOVA model with terms for country, treatment, and ranked baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|Ranked ANCOVA|Treatment comparisons were performed only if the corresponding numerical change from Baseline at the same visit was statistically significant.||Week 4||||0.0025
70877927|NCT00546637|141239808|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1748||95.0|-0.3|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||0.0|-0.3|0.1748
70877928|NCT00546637|141239808|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.6572||95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.2|-0.1|0.6572
70877929|NCT00546637|141239810|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|0.6||0.0051||95.0|-2.9|-0.5||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||-0.5|-2.9|0.0051
70877930|NCT00546637|141239810|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|0.7||0.1231||95.0|-2.3|0.3||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.3|-2.3|0.1231
70877931|NCT00546637|141239811|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.4||0.3579||95.0|-1.0|0.4||P-value was based on an ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||0.4|-1.0|0.3579
70877932|NCT00546637|141239811|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.4||0.9274||95.0|-0.8|0.7||P-value was based on an ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.7|-0.8|0.9274
70877933|NCT00546637|141239812|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0223||95.0|-0.7|-0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||-0.1|-0.7|0.0223
70957870|NCT01090427|141419323|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] will be used as factors in the model.||||||<0.001
70957871|NCT01090427|141419324|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
70957872|NCT01090427|141419324|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
70957873|NCT01090427|141419325|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PGA of 0||||<0.001
70957874|NCT01090427|141419325|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PGA of 0||||<0.001
70957875|NCT01090427|141419325|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PGA of 0, 1, or 2||||<0.001
70957876|NCT01090427|141419325|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PGA of 0, 1, or 2||||<0.001
70877934|NCT00546637|141239812|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1744||95.0|-0.6|0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.1|-0.6|0.1744
70877935|NCT00546637|141239813|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.7564||95.0|-0.4|0.5||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||0.5|-0.4|0.7564
70877936|NCT00546637|141239813|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.401||95.0|-0.3|0.7||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.7|-0.3|0.4010
70957877|NCT01090427|141419326|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PASI 50 responders||||<0.001
70957878|NCT01090427|141419326|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PASI 50 responders||||<0.001
70957879|NCT01090427|141419326|SUPERIORITY_OR_OTHER|||||||0.014|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||Participants with PASI score of 0||||0.014
70957880|NCT01090427|141419326|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||Participants with PASI score of 0||||<0.001
70957881|NCT01090427|141419327|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] were used as factors in the model.||PedsQL Total Scale Score||||0.003
70957882|NCT01090427|141419327|SUPERIORITY_OR_OTHER|||||||0.028|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] were used as factors in the model.||PedsQL Total Scale Score||||0.028
70957883|NCT01090427|141419327|SUPERIORITY_OR_OTHER|||||||0.005|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] were used as factors in the model.||PedsQL Psychosocial health summary score||||0.005
70957884|NCT01090427|141419327|SUPERIORITY_OR_OTHER|||||||0.063|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] were used as factors in the model.||PedsQL Psychosocial health summary score||||0.063
70957885|NCT01090427|141419327|SUPERIORITY_OR_OTHER|||||||0.007|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] were used as factors in the model.||PedsQL Physical health summary score||||0.007
70957886|NCT01090427|141419327|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] were used as factors in the model.||PedsQL Physical health summary score||||0.020
70957887|NCT01090427|141419328|SUPERIORITY_OR_OTHER|||||||0.027|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||0.027
70957888|NCT01090427|141419328|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
70957889|NCT00107120|141419423|SUPERIORITY_OR_OTHER||Least Square Means Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.458||0.022||95.0|-6.2|-0.5||Two-sided at 5% level of significance p \< 0.05 considered significant|ANCOVA|The model included study center and treatment as factors and baseline core as covariate|Differences are Escitalopram-Placebo|The null hypothesis is that there is no difference in the Change from Baseline to Week 8 in CDRS-R total score between treatment groups. The power calculation was based on the change from baseline to Week 8 in CDRS-R total score (LOCF approach). Assuming an effect size (treatment group difference relative to standard deviation) of 0.325, a sample size of approximately 150 patients per treatment group was used to provide at least 80% power at a significance level of 0.05 using a two-sided test.||-0.5|-6.2|0.022
70957890|NCT00107120|141419424|SUPERIORITY_OR_OTHER||Least Square Means Difference|-0.344|STANDARD_ERROR_OF_MEAN|0.1128||0.008||95.0|-0.595|0.092||Two-sided at 5% level of significance|ANCOVA|The model included treatment and center as factors and baseline CGI-Severity score as covariate.|Differences are Escitalopram-Placebo|Missing values were imputed using the LOCF approach.||0.092|-0.595|0.008
70957891|NCT00107120|141419425|SUPERIORITY_OR_OTHER||Least Square Means Difference|2.169|STANDARD_ERROR_OF_MEAN|1.324||0.103||95.0|-0.439|4.777||Two-sided at 5% level of significance|ANCOVA||Differences are Escitalopram-Placebo|ANCOVA on the Change from Baseline to Week 8 in CGAS score. The model included treatment and center as factors and baseline score as covariate. Missing values were imputed using the LOCF approach.||4.777|-0.439|0.103
70957892|NCT00896051|141419433|SUPERIORITY_OR_OTHER||Least Squares (LS) Means Ratio|0.82|||||TWO_SIDED|90.0|0.55|1.22|||Linear mixed effects model|A linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.||Parameter: minimum plasma concentration (Cmin)||1.22|0.55|
70957893|NCT00896051|141419433|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Ratio|0.96|||||TWO_SIDED|90.0|0.8|1.16|||Linear mixed effects model|A linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.||Parameter: maximum plasma concentration (Cmax)||1.16|0.80|
70957894|NCT00896051|141419434|SUPERIORITY_OR_OTHER||Least Squares (LS) Means Ratio|0.96|||||TWO_SIDED|90.0|0.76|1.22|||Linear mixed effects model|linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.||Parameter: area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr)||1.22|0.76|
70957895|NCT00896051|141419435|SUPERIORITY_OR_OTHER||Least Squares (LS) Means Ratio|0.91|||||TWO_SIDED|90.0|0.63|1.33|||Linear mixed effects model|A linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.||Parameter: Minimum plasma concentration (Cmin)||1.33|0.63|
70957896|NCT00896051|141419435|SUPERIORITY_OR_OTHER||Least Squares (LS) Means Ratio|1.05|||||TWO_SIDED|90.0|0.86|1.27|||Linear mixed effects model|A linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.||Parameter: maximum plasma concentration (Cmax)||1.27|0.86|
70957897|NCT00896051|141419436|SUPERIORITY_OR_OTHER||Least Squares (LS) Means Ratio|0.99|||||TWO_SIDED|90.0|0.81|1.21|||Llinear mixed effects model|A linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.||Parameter: area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr)||1.21|0.81|
70957898|NCT00876928|141419455|SUPERIORITY_OR_OTHER||Percent of patients developing diabetes|10.0||||0.61|TWO_SIDED|95.0|8.0|12.0||A chi square test was used for the number of participants developing diabetes and a 2-way repeated measures ANOVA for the disposition index|Chi-squared||Primary outcome compared the number of participants developing diabetes after receiving vitamin D or placebo for one year. Secondary outcome compared changes in 2-way repeated measures ANOVA; therefore,no confidence intervals/dispersion parameters|Null hypothesis is that there is no effect of vitamin D on the development of diabetes in people with pre-diabetes and hypovitaminosis D. There were no published data when this trial was started on the effect of vitamin D in pre-diabetes making a power calculation difficult.||12|8|0.61
70957899|NCT00876928|141419456|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||ANOVA|||The null hypothesis is that there would be no difference in the changes in the Disposition Index between the 2 groups over the year.||||0.39
70957900|NCT03719170|141419457|SUPERIORITY||Slope|0.0000684|||||TWO_SIDED|95.0|-0.0003|0.000413||||||"Power Calculation:~Assuming approximately the same number of eligible subjects in each VISN (with an average of 10,563 candidates per VISN) and an Intraclass correlation coefficient (ICC) of 0.12, randomizing 17 VISNs will give more than 80% power to detect % days on PPI of 75% vs. 50%, 85% vs. 60%, 80% vs. 55%, or 70% vs. 45%, but to detect a difference between 70% vs. 50%, power is only 61% using 0.05 level 2-sided test."||0.000413|-0.0003|
70957901|NCT01346475|141419488|SUPERIORITY_OR_OTHER||Incident Risk Ratio|0.54|||<|0.001|TWO_SIDED|95.0|0.44|0.66|||Incident risk ratio|The model is adjusted for period effects.||This study had 80% power to detect a 50% reduction in HSV genital shedding rates for high-dose valacyclovir compared to standard dose valacyclovir.||0.66|0.44|<0.001
70957902|NCT00955253|141419492|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||between the placebo and guanfacine conditions||||0.013
70957903|NCT00558259|141419494|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.08|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.02|0.25|||Regression, Cox|||Dabigatran vs placebo||0.25|0.02|<0.0001
70957904|NCT00558259|141419495|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.08|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.03|0.27|||Regression, Cox|||Dabigatran vs placebo||0.27|0.03|<0.0001
70957905|NCT00558259|141419496|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||< 0.0001
70877937|NCT00546637|141239814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1472||95.0|-0.2|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||0.0|-0.2|0.1472
70877938|NCT00546637|141239814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.5839||95.0|-0.2|0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.1|-0.2|0.5839
70877939|NCT00546637|141239815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.6621||95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q1||0.2|-0.1|0.6621
70877940|NCT00546637|141239815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.5|-0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q2||-0.2|-0.5|<.0001
70877941|NCT00546637|141239815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3242||95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q3||0.2|-0.1|0.3242
70877942|NCT00546637|141239815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1604||95.0|-0.3|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q4||0.0|-0.3|0.1604
70877943|NCT00546637|141239815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4102||95.0|-0.2|0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q5||0.1|-0.2|0.4102
70877944|NCT00546637|141239815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3079||95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q6||0.2|-0.1|0.3079
70877945|NCT00546637|141239815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4066|TWO_SIDED|95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q7||0.2|-0.1|0.4066
70877946|NCT00546637|141239816|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1595||95.0|0.0|0.3||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q1||0.3|-0.0|0.1595
70877947|NCT00546637|141239816|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0614||95.0|-0.3|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q2||0.0|-0.3|0.0614
70877948|NCT00546637|141239816|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.2032||95.0|-0.1|0.3||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q3||0.3|-0.1|0.2032
70877949|NCT00546637|141239816|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0631||95.0|-0.3|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q4||0.0|-0.3|0.0631
70877950|NCT00546637|141239816|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.9706||95.0|-0.2|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q5||0.2|-0.2|0.9706
70877951|NCT00546637|141239816|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8058||95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q6||0.2|-0.1|0.8058
70877952|NCT00546637|141239816|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3302|TWO_SIDED|95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q7||0.2|-0.1|0.3302
70877953|NCT00546637|141239817|SUPERIORITY_OR_OTHER|||||||0.1136||95.0||||P-value was obtained from a Cochran-Mantel-Haenszel test with modified ridit scoring, stratified by center. No adjustment of p-value was made for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.1136
70877954|NCT00546637|141239818|SUPERIORITY_OR_OTHER|||||||0.5775||95.0||||P-value was obtained from a Cochran-Mantel-Haenszel test with modified ridit scoring, stratified by center. No adjustment of p-value was made for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.5775
70877955|NCT00546637|141239819|SUPERIORITY_OR_OTHER|||||||0.7433||95.0||||P-value was obtained from a Cochran-Mantel-Haenszel test with modified ridit scoring, stratified by center. No adjustment of p-value was made for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.7433
70877956|NCT00546637|141239820|SUPERIORITY_OR_OTHER|||||||0.9402||95.0||||P-value was obtained from a Cochran-Mantel-Haenszel test with modified ridit scoring, stratified by center. No adjustment of p-value was made for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.9402
70877957|NCT00546637|141239821|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7|STANDARD_ERROR_OF_MEAN|0.9||0.004||95.0|-4.5|-0.9||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||-0.9|-4.5|0.0040
70957906|NCT00558259|141419496|SUPERIORITY_OR_OTHER||Percentage of participants with events|0.3|||||TWO_SIDED|95.0|0.04|1.06|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing DVT in Dabigatran group.|||1.06|0.04|
70877958|NCT00546637|141239821|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.8|STANDARD_ERROR_OF_MEAN|1.0||0.0068||95.0|-4.8|-0.8||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||-0.8|-4.8|0.0068
70877959|NCT00546637|141239822|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|0.9||0.0412||95.0|0.1|3.6||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net)= Least squares mean|Week 4||3.6|0.1|0.0412
70877960|NCT00546637|141239822|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5|STANDARD_ERROR_OF_MEAN|1.0||0.1373||95.0|-0.5|3.4||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net)= Least squares mean|Week 12||3.4|-0.5|0.1373
70877961|NCT00546637|141239823|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.7|STANDARD_ERROR_OF_MEAN|1.0||0.0941||95.0|-0.3|3.8||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net) = Least squares mean|Week 4||3.8|-0.3|0.0941
70877962|NCT00546637|141239823|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|1.1||0.2273||95.0|-0.8|3.4||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net) = Least squares mean|Week 12||3.4|-0.8|0.2273
70877963|NCT00546637|141239824|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.1|STANDARD_ERROR_OF_MEAN|1.1||0.0507||95.0|0.0|4.3||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net)= Least squares mean|Week 4||4.3|-0.0|0.0507
70877964|NCT00546637|141239824|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|1.2||0.1136||95.0|-0.4|4.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net)= Least squares mean|Week 12||4.1|-0.4|0.1136
70877965|NCT00546637|141239825|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|1.1||0.0845||95.0|-0.3|4.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net)= Least squares mean|Week 4||4.1|-0.3|0.0845
70877966|NCT00546637|141239825|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2|STANDARD_ERROR_OF_MEAN|1.2||0.0662||95.0|-0.2|4.6||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net) = Least squares mean|Week 12||4.6|-0.2|0.0662
70877967|NCT00546637|141239826|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|0.9||0.1085||95.0|-0.3|3.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net) = Least squares mean|Week 4||3.2|-0.3|0.1085
70877968|NCT00546637|141239826|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.9||0.7685||95.0|-1.6|2.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net) = Least squares mean|Week 12||2.1|-1.6|0.7685
70877969|NCT00546637|141239827|SUPERIORITY_OR_OTHER||Median Difference (Net)|6.0||||0.0005||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|Week 4||||0.0005
70877970|NCT00546637|141239827|SUPERIORITY_OR_OTHER||Median Difference (Net)|7.0|||<|0.0001||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|Week 8||||<.0001
70877971|NCT00546637|141239827|SUPERIORITY_OR_OTHER||Median Difference (Net)|9.0||||0.0003||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|Week 12||||0.0003
70877972|NCT00546637|141239828|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.4||||0.2251||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|||||0.2251
70877973|NCT01074450|141239831|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.93|||||TWO_SIDED|90.0|94.23|108.1|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.1|94.23|
70877974|NCT01074450|141239832|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|104.71|||||TWO_SIDED|90.0|99.74|109.92|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||109.92|99.74|
70877975|NCT01074450|141239833|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|104.15|||||TWO_SIDED|90.0|99.05|109.52|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||109.52|99.05|
70877976|NCT04984993|141239850|OTHER||||||<|0.001||||||Significance level of 0.025|t-test, 1 sided|||Null hypothesis: mu \<= 0 versus alternative hypothesis: mu \>0, where mu is the population mean change from baseline in the EF domain of the IIEF questionnaire at week 24.||||<0.001
70877977|NCT04984993|141239851|OTHER||||||<|0.001||||||Significance level of 0.025|t-test, 1 sided|||Null hypothesis: mu \<= 30 versus alternative hypothesis: mu \>30, where mu is the population mean percentage of MED3000 uses per patient that resulted in the patient noticing their erection starting within 15 minutes.||||<0.001
70877978|NCT04984993|141239851|OTHER||||||<|0.001||||||Significance level of 0.025|t-test, 1 sided|||Null hypothesis: mu \<= 30 versus alternative hypothesis: mu \>30, where mu is the population mean percentage of MED3000 uses per patient that resulted in the patient noticing their erection starting within 10 minutes.||||<0.001
70877979|NCT04984993|141239851|OTHER|||||||0.89||||||Significance level of 0.025|t-test, 1 sided|||Null hypothesis: mu \<= 30 versus alternative hypothesis: mu \>30, where mu is the population mean percentage of MED3000 uses per patient that resulted in the patient noticing their erection starting within 5 minutes.||||0.890
70957907|NCT00558259|141419496|SUPERIORITY_OR_OTHER||Percentage of participants with events|3.5|||||TWO_SIDED|95.0|2.21|5.17|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing DVT in placebo group.|||5.17|2.21|
70957908|NCT00558259|141419497|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Fisher Exact|||Dabigatran vs. Placebo||||0.0004
70957909|NCT00558259|141419497|SUPERIORITY_OR_OTHER||Percentage of participants with events|0.1|||||TWO_SIDED|95.0|0.0|0.82|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing PE in Dabigatran group.|||0.82|0.00|
70957910|NCT00558259|141419497|SUPERIORITY_OR_OTHER||Percentage of participants with events|2.1|||||TWO_SIDED|95.0|1.16|3.52|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing PE in placebo group.|||3.52|1.16|
70957911|NCT00558259|141419498|SUPERIORITY_OR_OTHER|||||||0.2428|||||||Fisher Exact|||Dabigatran vs. Placebo||||0.2428
70957912|NCT00558259|141419498|SUPERIORITY_OR_OTHER||Percentage of participants with events|0.0|||||TWO_SIDED|95.0|0.0|0.54|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants with unexplained death in Dabigatran group.|||0.54|0.00|
70957913|NCT00558259|141419498|SUPERIORITY_OR_OTHER||Percentage of participants with events|0.3|||||TWO_SIDED|95.0|0.04|1.09|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants with unexplained death in placebo group.|||1.09|0.04|
70957914|NCT00558259|141419499|SUPERIORITY_OR_OTHER|||||||0.4998||||||As the Cox model did not converge due to too few events, hazard ratios are not estimable.|Fisher Exact|||Dabigatran vs. Placebo - Analysis of time to first occurrence of an MBE during the treatment period - FAS - as treated.||||0.4998
70957915|NCT00558259|141419499|SUPERIORITY_OR_OTHER||Percentage of participants with events|0.3|||||TWO_SIDED|95.0|0.04|1.05|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing MBE in Dabigatran group.|||1.05|0.04|
70957916|NCT00558259|141419499|SUPERIORITY_OR_OTHER||Percentage of participants with events|0.0|||||TWO_SIDED|95.0|0.0|0.56|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing MBE in placebo group.|||0.56|0.00|
70957917|NCT00558259|141419499|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.92|STANDARD_ERROR_OF_MEAN|0.97||0.0013|TWO_SIDED|95.0|1.52|5.6|||Regression, Cox|||Dabigatran vs. Placebo- Analysis of time to first occurrence of a MBE or CRBE during the treatment period - FAS - as treated.||5.60|1.52|0.0013
70957918|NCT00558259|141419499|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.82|STANDARD_ERROR_OF_MEAN|0.36||0.0027|TWO_SIDED|95.0|1.23|2.68|||Regression, Cox|||Dabigatran vs. Placebo- Analysis of time to first occurrence of any bleeding event during the treatment period - FAS - as treated||2.68|1.23|0.0027
70957919|NCT02874924|141419502|EQUIVALENCE|Pilot study, therefore, no power calculation available.|Mean Difference (Net)|-1.81||||0.56|TWO_SIDED|95.0|-8.48|4.86|||t-test, 2 sided|||Null hypothesis||4.86|-8.48|0.56
70957920|NCT00370331|141419543|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.2|||<|0.001||99.0|3.59|18.73|||Repeated measures model for binary data|Repeated measures model for binary data using Generalized Estimating Equations (GEE)||||18.73|3.59|<0.001
70957921|NCT01052103|141419568|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|1.0|STANDARD_ERROR_OF_MEAN|1.6||0.732||95.0||||One-sided p-value.|Type 3 Tests|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.732
70957922|NCT01052103|141419569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|2.2|STANDARD_ERROR_OF_MEAN|2.1||0.846||95.0||||One-sided p-value.|Type 3 Tests|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.846
70957923|NCT01052103|141419570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.201||95.0||||One-sided p-value.|Type 3 Tests|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.201
70957924|NCT01052103|141419571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|1.4|STANDARD_ERROR_OF_MEAN|1.3||0.136||95.0||||One-sided p-value.|Type 3 Tests|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.136
70957925|NCT01052103|141419572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|1.5|STANDARD_ERROR_OF_MEAN|2.4||0.739||95.0||||One-sided p-value.|Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.739
70877980|NCT04984993|141239852|OTHER||||||<|0.001||||||Significance level of 0.025|t-test, 1 sided|||||||<0.001
70877981|NCT04984993|141239852|OTHER|||||||0.3327||||||Significance level of 0.025|t-test, 1 sided|||||||0.3327
70957926|NCT01052103|141419573|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.19||95.0|||||Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.190
70957927|NCT01052103|141419574|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.702||95.0|||||Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.702
70957928|NCT01052103|141419575|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.851||95.0|||||Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.851
70957929|NCT01052103|141419579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.0||||0.999|TWO_SIDED|95.0|-4.3|4.3||P-value is for standing systolic BP.|Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||4.3|-4.3|0.999
70957930|NCT01052103|141419579|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|3.8||||0.009|TWO_SIDED|95.0|1.0|6.7||P-value is for standing diastolic BP.|Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||6.7|1.0|0.009
70957931|NCT01052103|141419580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.5||||0.818|TWO_SIDED|95.0|-5.0|3.9|||Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||3.9|-5.0|0.818
70957932|NCT01052103|141419581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.44||||0.571|TWO_SIDED|95.0|-1.98|1.1|||Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||1.10|-1.98|0.571
70957933|NCT01052103|141419586|SUPERIORITY_OR_OTHER_LEGACY|||||||0.682||95.0||||P-value is for treatment-emergent suicidal ideation.|Fisher Exact|||||||0.682
70957934|NCT01052103|141419587|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|1.0|STANDARD_ERROR_OF_MEAN|1.7||0.727||95.0||||One-sided p-value.|Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.727
70957935|NCT01052103|141419591|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-1.7|STANDARD_ERROR_OF_MEAN|3.4||0.305||95.0||||One-sided p-value.|Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.305
70877982|NCT04984993|141239852|OTHER||||||>|0.999||||||Significance level of 0.025|t-test, 1 sided|||||||>0.999
70957936|NCT01052103|141419592|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.5|STANDARD_ERROR_OF_MEAN|2.5||0.42||95.0||||One-sided p-value.|Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.420
70957937|NCT00545051|141419623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.25|||<|0.001|TWO_SIDED|95.0|2.09|4.41|||ANCOVA|||||4.41|2.09|<0.001
70957938|NCT00545051|141419624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22|||<|0.001|TWO_SIDED|95.0|1.22|3.23|||ANCOVA|||||3.23|1.22|<0.001
70957939|NCT00545051|141419625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55||||0.122|TWO_SIDED|95.0|-0.15|1.25|||ANCOVA|||Month 6||1.25|-0.15|0.122
70957940|NCT00545051|141419625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81|||<|0.001|TWO_SIDED|95.0|0.96|2.66|||ANCOVA|||Month 12||2.66|0.96|<0.001
70957941|NCT00545051|141419626|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||sCTX at Month 1||||<0.001
70957942|NCT00545051|141419626|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||sCTX at Month 6||||<0.001
70957943|NCT00545051|141419626|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||sCTX at Month 12||||<0.001
70957944|NCT00545051|141419626|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||P1NP at Month 1||||<0.001
70957945|NCT00545051|141419626|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||P1NP at Month 6||||<0.001
70957946|NCT00545051|141419626|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||P1NP at Month 12||||<0.001
70957947|NCT00545051|141419626|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||TRACP at Month 1||||<0.001
70877983|NCT02865187|141239855|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|7.0||0.71|TWO_SIDED|95.0|-7.4|5.1||a priori threshold for significance was set at p\<0.05|t-test, 2 sided|||||5.1|-7.4|0.71
70957948|NCT00545051|141419626|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||TRACP at Month 6||||<0.001
70957949|NCT00545051|141419626|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||TRACP at Month 12||||<0.001
70957950|NCT02469389|141419630|SUPERIORITY|Based on randomization to treatment condition, the model assumed no differences at BL (any difference was assumed due to random sampling error).||||||0.295|||||||Mixed Models Analysis|Post-hoc mixed effects model analyses of all outcomes were performed adjusting for BL CAINS MAP score.||Analyses of the primary and secondary outcomes utilized a linear mixed effects model accounting for random therapy group effects and included all available data at baseline (BL), post-treatment (PT; 12-week), and follow-up (FU; 24-week) timepoints (TPs). Error terms across TPs were assumed correlated with unstructured correlation matrix. To test time specific hypotheses, terms in the mean model included separate indicators for PT \& FU \& interaction terms between these indicators and conditions.||||0.295
70957951|NCT02469389|141419631|SUPERIORITY|||||||0.182|||||||Mixed Models Analysis|||||||0.182
70957952|NCT02469389|141419632|SUPERIORITY|||||||0.114|||||||Mixed Models Analysis|||||||0.114
70957953|NCT02469389|141419633|SUPERIORITY|||||||0.22|||||||Mixed Models Analysis|||||||0.220
70957954|NCT02469389|141419634|SUPERIORITY|||||||0.018|||||||Mixed Models Analysis|||||||0.018
70957955|NCT02469389|141419635|SUPERIORITY|||||||0.903|||||||Mixed Models Analysis|||||||0.903
70957956|NCT02469389|141419636|SUPERIORITY|||||||0.535|||||||Mixed Models Analysis|||||||0.535
70957957|NCT02469389|141419637|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.010
70957958|NCT02469389|141419638|SUPERIORITY|||||||0.692|||||||Mixed Models Analysis|||||||0.692
70957959|NCT02469389|141419639|SUPERIORITY|||||||0.498|||||||Mixed Models Analysis|||||||0.498
70957960|NCT02469389|141419640|SUPERIORITY|||||||0.079|||||||Mixed Models Analysis|||||||0.079
70957961|NCT02469389|141419641|SUPERIORITY|||||||0.539|||||||Mixed Models Analysis|||||||0.539
70957962|NCT01079663|141419642|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.1629|TWO_SIDED|95.0|-1.19|0.2|||Mixed Models Analysis|||||0.20|-1.19|0.1629
70957963|NCT01079663|141419643|SUPERIORITY||Mean Difference (Final Values)|-0.76||||0.0347|TWO_SIDED|95.0|-1.46|-0.06|||Mixed Models Analysis|||||-0.06|-1.46|0.0347
70957964|NCT02054741|141419662|SUPERIORITY||Risk Ratio (RR)|0.74||||0.0001|TWO_SIDED|95.0|0.64|0.86|||Mixed Models Analysis|Generalized Linear Mixed Model||||0.86|0.64|0.0001
70957965|NCT02054741|141419663|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.39|TWO_SIDED|95.0|0.85|1.5|||Regression, Cox|||||1.50|0.85|0.39
70957966|NCT02054741|141419664|SUPERIORITY||Risk Ratio (RR)|1.38||||0.015|TWO_SIDED|95.0|1.06|1.78|||Mixed Models Analysis|Generalized Linear Mixed Model||||1.78|1.06|0.015
70957967|NCT00986973|141419707|SUPERIORITY_OR_OTHER||||||>|0.05|ONE_SIDED||||||t-test, 2 sided|||||||>0.05
70957968|NCT00986973|141419708|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||Friedman test|Non-parametric test was used to examine neuropsychological outcomes||||||0.82
70957969|NCT00986973|141419709|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Friedman test|Non-parametric test was used to examine neuropsychological outcomes||||||0.46
70957970|NCT00986973|141419710|SUPERIORITY_OR_OTHER|||||||0.071|TWO_SIDED||||||Friedman test|Non-parametric test was used to examine neuropsychological outcomes||||||0.071
70957971|NCT00986973|141419711|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Friedman test|Non-parametric test was used to examine neuropsychological outcomes||||||0.25
70957972|NCT00986973|141419712|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Friedman test|Non-parametric test was used to examine neuropsychological outcomes||||||0.050
70957973|NCT00986973|141419713|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.34
70957974|NCT00598273|141419714|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 97.5% confidence interval for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ -1.0 g/dL.|Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.099|||TWO_SIDED|97.5|-0.19|0.26|||ANOVA|The ANOVA cell means model was used to estimate primary efficacy endpoint within the specified cells formed by the combination of treatment and strata||The sample size for this study was determined based on a two-group evaluation of non-inferiority in means with a non-inferiority margin (Δ) of -1.0 g/dL (one-sided significance level of 0.0125, or, comparably, a two-sided significance level of 0.025). A sample size of 450 (150 per treatment group) provided power greater than 99% for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a pooled standard deviation of 1.5 g/dL.||0.26|-0.19|
70957975|NCT00598273|141419714|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 97.5% confidence interval for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ -1.0 g/dL.|Least Squares Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.098|||TWO_SIDED|97.5|0.04|0.48|||ANOVA|The ANOVA cell means model was used to estimate primary efficacy endpoint within the specified cells formed by the combination of treatment and strata||The sample size for this study was determined based on a two-group evaluation of non-inferiority in means with a non-inferiority margin (Δ) of -1.0 g/dL (one-sided significance level of 0.0125, or, comparably, a two-sided significance level of 0.025). A sample size of 450 (150 per treatment group) provided power greater than 99% for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a pooled standard deviation of 1.5 g/dL.||0.48|0.04|
70957976|NCT00598273|141419715|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.25|||||TWO_SIDED|95.0|0.51|3.1|||Cochran-Mantel-Haenszel|||||3.10|0.51|
70957977|NCT00598273|141419715|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.48|||||TWO_SIDED|95.0|0.62|3.56|||Cochran-Mantel-Haenszel|||||3.56|0.62|
70957978|NCT00598273|141419716|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.94|1.05|||Cochran-Mantel-Haenszel|||||1.05|0.94|
70877984|NCT02865187|141239856|SUPERIORITY||Chi square|0.0||||1|TWO_SIDED|||||a priori threshold for significance was set at p\< 0.05.|Chi-squared|||||||1.00
70957979|NCT00598273|141419716|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.95|1.06|||Cochran-Mantel-Haenszel|||||1.06|0.95|
70957980|NCT02891408|141419809|OTHER||Geometric least-square mean (GLSM) ratio|181.0|||||TWO_SIDED|90.0|98.0|332.0||||||AUClast of Firsocostat||332|98|
70957981|NCT02891408|141419809|OTHER||GLSM ratio|881.0|||||TWO_SIDED|90.0|488.0|1589.0||||||AUClast of Firsocostat||1589|488|
70957982|NCT02891408|141419809|OTHER||GLSM ratio|3081.0|||||TWO_SIDED|90.0|2446.0|3881.0||||||AUClast of Firsocostat||3881|2446|
70957983|NCT02891408|141419809|OTHER||GLSM ratio|430.0|||||TWO_SIDED|90.0|185.0|998.0||||||AUClast of GS-834773||998|185|
70957984|NCT02891408|141419809|OTHER||GLSM ratio|4417.0|||||TWO_SIDED|90.0|1867.0|10449.0||||||AUClast of GS-834773||10449|1867|
70957985|NCT02891408|141419809|OTHER||GLSM ratio|14676.0|||||TWO_SIDED|90.0|7932.0|27153.0||||||AUClast of GS-834773||27153|7932|
70957986|NCT02891408|141419809|OTHER||GLSM ratio|122.0|||||TWO_SIDED|90.0|86.0|173.0||||||AUClast of Fenofibric Acid||173|86|
70957987|NCT02891408|141419810|OTHER||GLSM ratio|183.0|||||TWO_SIDED|90.0|100.0|337.0||||||AUCinf of Firsocostat||337|100|
70957988|NCT02891408|141419810|OTHER||GLSM ratio|869.0|||||TWO_SIDED|90.0|482.0|1568.0||||||AUCinf of Firsocostat||1568|482|
70957989|NCT02891408|141419810|OTHER||GLSM ratio|2976.0|||||TWO_SIDED|90.0|2389.0|3708.0||||||AUCinf of Firsocostat||3708|2389|
70957990|NCT02891408|141419810|OTHER||GLSM ratio|399.0|||||TWO_SIDED|90.0|179.0|892.0||||||AUCinf of GS-834773||892|179|
70957991|NCT02891408|141419810|OTHER||GLSM ratio|3843.0|||||TWO_SIDED|90.0|1641.0|9000.0||||||AUCinf of GS-834773||9000|1641|
70957992|NCT02891408|141419810|OTHER||GLSM ratio|10712.0|||||TWO_SIDED|90.0|6525.0|17585.0||||||AUCinf of GS-834773||17585|6525|
70957993|NCT02891408|141419810|OTHER||GLSM ratio|125.0|||||TWO_SIDED|90.0|89.0|174.0||||||AUCinf of Fenofibric Acid||174|89|
70957994|NCT02891408|141419811|OTHER||GLSM ratio|169.0|||||TWO_SIDED|90.0|87.0|326.0||||||Cmax of Firsocostat||326|87|
70957995|NCT02891408|141419811|OTHER||GLSM ratio|905.0|||||TWO_SIDED|90.0|537.0|1526.0||||||Cmax of Firsocostat||1526|537|
70957996|NCT02891408|141419811|OTHER||GLSM ratio|2719.0|||||TWO_SIDED|90.0|1994.0|3708.0||||||Cmax of Firsocostat||3708|1994|
70957997|NCT02891408|141419811|OTHER||GLSM ratio|391.0|||||TWO_SIDED|90.0|163.0|942.0||||||Cmax of GS-834773||942|163|
70957998|NCT02891408|141419811|OTHER||GLSM ratio|4470.0|||||TWO_SIDED|90.0|2170.0|9207.0||||||Cmax of GS-834773||9207|2170|
70957999|NCT02891408|141419811|OTHER||GLSM ratio|9278.0|||||TWO_SIDED|90.0|4945.0|17407.0||||||Cmax of GS-834773||17407|4945|
70958000|NCT02891408|141419811|OTHER||GLSM ratio|109.0|||||TWO_SIDED|90.0|81.0|146.0||||||Cmax of Fenofibric Acid||146|81|
70958001|NCT00709852|141419846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|STANDARD_DEVIATION|0.61|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
70958002|NCT00709852|141419846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.67|STANDARD_DEVIATION|0.66|<|0.0001||||||for border delineation|paired t-test|||||||< 0.0001
70958003|NCT00709852|141419846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62|STANDARD_DEVIATION|0.47|<|0.0001||||||for internal morphology|paired t-test|||||||< 0.0001
70958004|NCT00709852|141419847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.59|STANDARD_DEVIATION|0.77|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
70958005|NCT00709852|141419847|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.72|STANDARD_DEVIATION|0.78|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
70958006|NCT00709852|141419847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|STANDARD_DEVIATION|0.61|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
70958007|NCT00709852|141419848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06|STANDARD_DEVIATION|0.51|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
70958008|NCT00709852|141419848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43|STANDARD_DEVIATION|0.5|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
70958009|NCT00709852|141419848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_DEVIATION|0.52|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
70958010|NCT00709852|141419849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29|STANDARD_DEVIATION|0.56|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
70958011|NCT00709852|141419849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_DEVIATION|0.53|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
70958012|NCT00709852|141419849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61|STANDARD_DEVIATION|0.42|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
70958013|NCT00709852|141419850|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.39|STANDARD_DEVIATION|5.51|||TWO_SIDED|95.0|-0.199|0.984|||confidence interval for paired means|lower limit of interval is compared to noninferiority margin||BR 1||0.984|-0.199|
70958014|NCT00709852|141419850|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|-0.44|STANDARD_DEVIATION|12.38|||TWO_SIDED|95.0|-1.772|0.885|||confidence interval for paired means|lower limit of confidence interval (CI) is compared to noninferiority margin||BR 2||0.885|-1.772|
70958015|NCT00709852|141419850|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.56|STANDARD_DEVIATION|4.07|||TWO_SIDED|95.0|0.125|1.0|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||BR 3||1.000|0.125|
70958016|NCT00709852|141419850|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.17|STANDARD_DEVIATION|5.68|||TWO_SIDED|95.0|-0.439|0.78|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||AR||0.780|-0.439|
70958017|NCT00709852|141419851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.62|STANDARD_DEVIATION|0.3|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
70958018|NCT00709852|141419851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81|STANDARD_DEVIATION|0.37|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
70958019|NCT00709852|141419851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_DEVIATION|0.38|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
70958020|NCT00709852|141419852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.13|STANDARD_DEVIATION|0.62|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
70958021|NCT00709852|141419852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86|STANDARD_DEVIATION|0.46|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
70958022|NCT00709852|141419852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|STANDARD_DEVIATION|0.39|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
70958023|NCT00709852|141419853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.36|STANDARD_DEVIATION|0.33|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
70958024|NCT00709852|141419853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_DEVIATION|0.33|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
70958025|NCT00709852|141419853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43|STANDARD_DEVIATION|0.32|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
70958026|NCT00709852|141419854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|STANDARD_DEVIATION|0.3|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
70958027|NCT00709852|141419854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72|STANDARD_DEVIATION|0.23|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
70958028|NCT00709852|141419854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.76|STANDARD_DEVIATION|0.22|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
70958029|NCT00709852|141419855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83|STANDARD_DEVIATION|1.16|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
70958030|NCT00709852|141419855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52|STANDARD_DEVIATION|1.26|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
70958031|NCT00709852|141419855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_DEVIATION|0.82|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
70958032|NCT00709852|141419856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89|STANDARD_DEVIATION|1.29|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
70958033|NCT00709852|141419856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.54|STANDARD_DEVIATION|1.44|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
70958034|NCT00709852|141419856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48|STANDARD_DEVIATION|1.11|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
70958035|NCT00709852|141419857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|STANDARD_DEVIATION|0.95|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
70958036|NCT00709852|141419857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|STANDARD_DEVIATION|0.97|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
70958037|NCT00709852|141419857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39|STANDARD_DEVIATION|0.96|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
70958038|NCT00709852|141419858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.78|STANDARD_DEVIATION|1.06|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
70958039|NCT00709852|141419858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_DEVIATION|1.07|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
70958040|NCT00709852|141419858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42|STANDARD_DEVIATION|0.83|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
70958041|NCT00709852|141419859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24|STANDARD_DEVIATION|0.53|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
70958042|NCT00709852|141419859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|STANDARD_DEVIATION|0.48|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
70958043|NCT00709852|141419859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|STANDARD_DEVIATION|0.41|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
70958044|NCT00709852|141419860|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.16|STANDARD_DEVIATION|6.44|||TWO_SIDED|95.0|-0.532|0.851|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||||0.851|-0.532|
70958045|NCT00709852|141419861|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.33||||95.0|0.0004|0.078|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for contrast enhancement||0.078|0.0004|
70958046|NCT00709852|141419861|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.41||||95.0|-0.009|0.082|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for border delineation||0.082|-0.009|
70958047|NCT00709852|141419861|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.03|STANDARD_DEVIATION|0.29||||95.0|-0.006|0.059|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for internal morphology||0.059|-0.006|
70958048|NCT00709852|141419862|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.01|STANDARD_DEVIATION|5.7||||95.0|-0.601|0.622|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||||0.622|-0.601|
70958049|NCT00709852|141419863|SUPERIORITY_OR_OTHER||Difference in percentages|8.3|||||||||||||for BR1|||||
70958050|NCT00709852|141419863|SUPERIORITY_OR_OTHER||Difference in percentages|-0.9|||||||||||||for BR2|||||
70958051|NCT00709852|141419863|SUPERIORITY_OR_OTHER||Difference in percentages|15.8|||||||||||||for BR3|||||
70958052|NCT00709852|141419863|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|8.9|||||TWO_SIDED|95.0|-0.5|18.4|||CI for paired percentages|confidence interval is given for AR; lower limit is compared to the noninferiority margin||||18.4|-0.5|
70958053|NCT00709852|141419864|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|3.6||||||95.0|-5.9|13.1|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||13.1|-5.9|
70958054|NCT00709852|141419865|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|8.3||||||95.0|-0.9|17.6|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||17.6|-0.9|
70958055|NCT00709852|141419866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|STANDARD_DEVIATION|0.78|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
70877985|NCT00810407|141239906|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||"The factor tested was diagnosis. The null hypothesis was that there was no association between diagnosis and the number of participants with treatment-related adverse events."||||<0.001
70877986|NCT00810407|141239907|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||"The factor tested was gender. The null hypothesis was that there was no association between gender and the number of participants with treatment-related adverse events."||||<0.001
70877987|NCT00810407|141239908|SUPERIORITY_OR_OTHER|||||||0.587|||||||Fisher Exact|||"The factor tested was age. The null hypothesis was that there was no association between age of participants and the number of participants with treatment-related adverse events."||||0.587
70877988|NCT00810407|141239908|SUPERIORITY_OR_OTHER|||||||0.428|||||||Cochran-Armitage (EXACT)|||"The factor tested was age. The null hypothesis was that there was no ordinal trend in the number of participants with treatment-related adverse events across the age at baseline."||||0.428
70958056|NCT00709852|141419866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61|STANDARD_DEVIATION|0.61|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
70877989|NCT02574247|141239915|OTHER|||||||0.34|||||||Spearman partial rank correlation|Age and high-frequency pure-tone average controlled for.||Statistical analysis for the row CRM at -9 dB SNR||||0.34
70958057|NCT00709852|141419867|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.29|STANDARD_DEVIATION|3.21||||95.0|-0.053|0.636|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||||0.636|-0.053|
70958058|NCT00709852|141419868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_DEVIATION|0.64|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
70958059|NCT00709852|141419868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64|STANDARD_DEVIATION|0.5|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
70877990|NCT02574247|141239915|OTHER|||||||0.64|||||||Spearman partial rank correlation|Age and high-frequency pure-tone average controlled for.||Statistical analysis for the row CRM at -6 dB SNR||||0.64
70877991|NCT02574247|141239915|OTHER|||||||0.24|||||||Spearman partial rank correlation|Age and high-frequency average controlled for.||Statistical analysis for the row IEEE at -6 dB SNR||||0.24
70877992|NCT02574247|141239915|OTHER|||||||0.2|||||||Spearman partial rank correlation|Age and high-frequency average controlled for.||Statistical analysis for the row IEEE at -3 dB SNR||||0.20
70877993|NCT02574247|141239918|OTHER|||||||0.03|||||||Spearman partial rank correlation|Age and high-frequency pure-tone average controlled for.||Statistical analysis for the row CRM slope||||0.03
70877994|NCT02574247|141239918|OTHER|||||||0.04|||||||Spearman partial rank correlation|Age and high-frequency pure-tone average controlled for.||Statistical analysis for row IEEE slope||||0.04
70877995|NCT02707991|141239920|SUPERIORITY||Mean Difference (Final Values)|22.0|STANDARD_ERROR_OF_MEAN|0.115||0.036|ONE_SIDED|||||one-sided test|z-test for difference in proportions|||||||0.036
70877996|NCT01528254|141239937|SUPERIORITY||Hazard Ratio (HR)|0.51|||<|0.001|TWO_SIDED|95.0|0.45|0.58|||Regression, Cox|||||0.58|0.45|<0.001
70877997|NCT01528254|141239938|OTHER||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.01||0.042|TWO_SIDED|95.0|-0.05|0.0|||Mixed Models Analysis|||||0.00|-0.05|0.042
70877998|NCT01528254|141239939|OTHER||Slope|0.09|STANDARD_ERROR_OF_MEAN|0.19||0.635|TWO_SIDED|95.0|-0.29|0.47|||Mixed Models Analysis|||||0.47|-0.29|0.635
70877999|NCT01528254|141239940|OTHER||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.53|TWO_SIDED|95.0|-0.05|0.02|||Mixed Models Analysis|||||0.02|-0.05|0.530
70878000|NCT01528254|141239941|OTHER||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.32||0.381|TWO_SIDED|95.0|-0.35|0.9|||Mixed Models Analysis|||||0.90|-0.35|0.381
70878001|NCT01528254|141239942|OTHER||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.23||0.744|TWO_SIDED|95.0|-0.53|0.38|||Mixed Models Analysis|||From Week 13 to end of Period 1||0.38|-0.53|0.744
70878002|NCT01528254|141239942|OTHER||Slope|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.017|TWO_SIDED|95.0|-0.91|-0.09|||Mixed Models Analysis|||From Week 13 to end of Period 2||-0.09|-0.91|0.017
70878003|NCT01528254|141239942|OTHER||Slope|-0.58|STANDARD_ERROR_OF_MEAN|0.21||0.006|TWO_SIDED|95.0|-0.99|-0.17|||Mixed Models Analysis|||From Week 13 to end of study||-0.17|-0.99|0.006
70878004|NCT01528254|141239943|OTHER||Slope|-5.03|STANDARD_ERROR_OF_MEAN|2.16||0.02|TWO_SIDED|95.0|-9.26|-0.79|||Mixed Models Analysis|||From Week 13 to end of Period 1||-0.79|-9.26|0.020
70878005|NCT01528254|141239943|OTHER||Slope|-5.08|STANDARD_ERROR_OF_MEAN|1.73||0.003|TWO_SIDED|95.0|-8.46|-1.69|||Mixed Models Analysis|||From Week 13 to end of Period 2||-1.69|-8.46|0.003
70878006|NCT01528254|141239943|OTHER||Slope|-5.38|STANDARD_ERROR_OF_MEAN|1.64||0.001|TWO_SIDED|95.0|-8.61|-2.16|||Mixed Models Analysis|||From Week 13 to end of study||-2.16|-8.61|0.001
70878007|NCT04339296|141239948|EQUIVALENCE|An independent sample t-test was performed between intervention and control group to determine if the difference of the mean medication adherence is equal to zero (null hypothesis).|Mean Difference (Net)|7.18|||<|0.01|TWO_SIDED|||||Statistical test was set at 95% confidence level.|t-test, 2 sided||Medication Adherence Difference = Intervention Adherence - Control Adherence|||||<0.01
70878008|NCT04339296|141239949|EQUIVALENCE|The null hypothesis assumes that the true mean difference for intervention participants self-reported medication adherence scores (from baseline to 6-month) is equal to zero.|Mean Difference (Net)|-1.5|||<|0.01|TWO_SIDED|||||Statistical test was set at 95% confidence level.|t-test, 2 sided||Mean difference (intervention participants self-reported score) = baseline minus 6-month.|||||<0.01
70878009|NCT04339296|141239949|EQUIVALENCE|The null hypothesis assumes that the true mean difference for control participants self-reported medication adherence scores (from baseline to 6-month) is equal to zero.|Mean Difference (Net)|-1.07||||0.07|TWO_SIDED|||||Statistical tests was set at 95% confidence level.|t-test, 2 sided||Mean difference (control participants self-reported score) = baseline minus 6-month.|||||0.07
70878010|NCT04446377|141239957|SUPERIORITY|The alternative hypothesis for the statistical testing was that LAM-002A would induce greater changes in viral load from Day 1 to Day 4 than would Placebo.|Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.51||0.35|TWO_SIDED|95.0|-1.47|0.53||Pre-specified 2-sided significance level of 0.20|Mixed Models Analysis|ANCOVA linear mixed model to evaluate the relative differences between the LAM-002A and Placebo groups in the log10 viral load from Day 1 to Day 4.|The difference between the groups (LAM-002A vs Placebo).|The analysis tested whether the viral load in nasopharyngeal samples was lower at Day 4 in those receiving LAM-002A compared to Placebo.||0.53|-1.47|0.35
70878011|NCT04446377|141239959|SUPERIORITY|The alternative hypothesis for the statistical testing was that LAM-002A would reduce the cumulative rate of hospitalization or death during the 28-day period comprising 10 days of study drug administration and a further 18 days of observation.|Odds Ratio (OR)|2.03||||0.55|TWO_SIDED|95.0|0.18|22.89|||Log Rank|||||22.89|0.18|0.55
70878012|NCT04446377|141239961|SUPERIORITY|The alternative hypothesis for the statistical testing was that a higher proportion of participants would have ≥95% oxygen saturation during LAM-002A administration than during Placebo administration as assessed across Days 1, 4, and 11 of the study drug course.|Risk Difference (RD)|-1.4|||||TWO_SIDED|||||||||Risk Difference from generalized estimating equations (GEE) logistic regression at Baseline||||
70878013|NCT04446377|141239961|SUPERIORITY|The alternative hypothesis for the statistical testing was that a higher proportion of participants would have ≥95% oxygen saturation during LAM-002A administration than during Placebo administration as assessed across Days 1, 4, and 11 of the study drug course.|Risk Difference (RD)|-1.0|||||TWO_SIDED|||||||||Risk Difference from GEE Logistic Regression at Day 1||||
70878014|NCT04446377|141239961|SUPERIORITY|The alternative hypothesis for the statistical testing was that a higher proportion of participants would have ≥95% oxygen saturation during LAM-002A administration than during Placebo administration as assessed across Days 1, 4, and 11 of the study drug course.|Risk Difference (RD)|-8.8|||||TWO_SIDED|||||||||Risk Difference from GEE logistic regression at Day 4||||
70878015|NCT04446377|141239961|SUPERIORITY|The alternative hypothesis for the statistical testing was that a higher proportion of participants would have ≥95% oxygen saturation during LAM-002A administration than during Placebo administration as assessed across Days 1, 4, and 11 of the study drug course.|Risk Difference (RD)|-3.7|||||TWO_SIDED|||||||||Risk Difference from GEE logistic regression at Day 11||||
70878016|NCT04446377|141239962|SUPERIORITY|The alternative hypothesis for the statistical testing was that, relative to Placebo, LAM-002A would result in a greater proportion of participants with a SARS-CoV-2 viral load \<LLOQ on Day 4.|Relative Risk|2.51||||0.2|TWO_SIDED|95.0|0.74|8.48||Prespecified significance level of 0.20.|Fisher Exact|||||8.48|0.74|0.20
70878017|NCT00840294|141239987|SUPERIORITY_OR_OTHER|||||||0.33|||||||t-test, 2 sided|||||||0.33
70958060|NCT00709852|141419869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|STANDARD_DEVIATION|1.26|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
70878018|NCT04059094|141240010|OTHER||Adjusted means difference|1.5|STANDARD_ERROR_OF_MEAN|2.45||0.5468|TWO_SIDED|95.0|-3.5|6.5|||Mixed model with repeated measurements||Adjusted means difference was calculated as value from BI 1265162 200μg minus value from placebo group.|Mixed Model for Repeated Measures (MMRM) with fixed effects for baseline, visit, treatment, treatment-by-visit interaction, baseline-by-visit interaction, and random effect for patient was applied. No hypothesis testing was performed, as this trial was prematurely discontinued. MMRM only included data from 200µg BI and placebo, as the sample size of the BI 20µg, BI 50µg and BI 100µg dose levels was limited because of the premature discontinuation of the trial.||6.5|-3.5|0.5468
70878019|NCT04059094|141240011|OTHER||Adjuste means difference|2.1|STANDARD_ERROR_OF_MEAN|1.83||0.3039|TWO_SIDED|95.0|-2.4|6.5|||ANCOVA||Adjusted means difference was calculated as value from BI 1265162 200μg minus value from placebo group.|ANCOVA based on analysis of covariance with fixed effects for baseline and treatment was applied. Statistical analysis was performed for 200μg BI and placebo groups only. No hypothesis testing was performed, as this trial was prematurely discontinued. ANCOVA only included data from 200µg BI and placebo, as the sample size of the BI 20µg, BI 50µg and BI 100µg dose levels was limited because of the premature discontinuation of the trial.||6.5|-2.4|0.3039
70878020|NCT01705288|141240027|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||Intention to Treat Analysis||||0.36
70878021|NCT01705288|141240028|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Intention to Treat Analysis||||0.05
70878022|NCT01705288|141240029|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
70878023|NCT01662908|141240057|OTHER||Mean Difference (Final Values)|8.8|STANDARD_ERROR_OF_MEAN|10.74|||TWO_SIDED|95.0|-12.7|30.2||||||||30.2|-12.7|
70878024|NCT00613938|141240083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|62.4|STANDARD_ERROR_OF_MEAN|11.9|<|0.001||95.0|39.01|85.73||Comparisons of tapentadol dose groups and placebo was performed with Hochberg procedure for adjustment for the multiple tests.|ANCOVA||The results shown are the treatment group differences between Tapentadol IR 50mg group and placebo.|Null hypothesis: There are no differences in pain intensity measured by SPID-48 hours between any of tapentadol dose groups and placebo. ANCOVA model with factors of treatment, center and baseline pain intensity score was used for the primary analysis.||85.73|39.01|<0.001
70878025|NCT02636868|141240089|SUPERIORITY|||||||0.363||||||a priori threshold of statistical significance set at 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline fraction of inspired oxygen (FiO₂) in model||Null hypothesis is no difference across treatment groups||||0.363
70878026|NCT02636868|141240089|SUPERIORITY|||||||0.36||||||a priori threshold of statistical significance set at 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis of no difference between treatments||||0.360
70878027|NCT02636868|141240089|SUPERIORITY|||||||0.461||||||a priori threshold of statistical significance set at 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis of no difference between treatments||||0.461
70878028|NCT02636868|141240090|SUPERIORITY|||||||0.401||||||a priori threshold of statistical significance set at 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis is no difference across treatment groups||||0.401
70878029|NCT02636868|141240090|SUPERIORITY|||||||0.372||||||a priori threshold of statistical significance set at 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis is no difference across treatment groups||||0.372
70878030|NCT02636868|141240090|SUPERIORITY|||||||0.648||||||a priori threshold of statistical significance set at 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis is no difference across treatment groups||||0.648
70878031|NCT02636868|141240091|SUPERIORITY|||||||0.996||||||a priori threshold of statistical significance set at 0.05|Log Rank|||Null hypothesis of no difference across treatments||||0.996
70878032|NCT02636868|141240091|SUPERIORITY|||||||0.951||||||a priori threshold of statistical significance set at 0.05|Log Rank|||Null hypothesis of no difference between treatments||||0.951
70878033|NCT02636868|141240091|SUPERIORITY|||||||0.995||||||a priori threshold of statistical significance set at 0.05|Log Rank|||Null hypothesis of no difference between treatments||||0.995
70958061|NCT00709852|141419869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|STANDARD_DEVIATION|0.97|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
70958062|NCT00709852|141419870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71|STANDARD_DEVIATION|0.76|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
70958063|NCT00709852|141419870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|STANDARD_DEVIATION|0.63|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
70958064|NCT00709852|141419871|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.28|STANDARD_DEVIATION|3.39||||95.0|-0.087|0.641|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||||0.641|-0.087|
70878034|NCT02636868|141240092|SUPERIORITY|||||||0.312||||||A priori threshold of statistical significance set at 0.10|Regression, Linear|Generalized linear model using Poisson distribution with pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis of no difference between treatment groups||||0.312
70878035|NCT02636868|141240092|SUPERIORITY|||||||0.094||||||A priori threshold of statistical significance set at 0.10|Regression, Linear|Generalized linear model using Poisson distribution with pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis of no difference between treatment groups||||0.094
70958065|NCT00709852|141419872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.78|STANDARD_DEVIATION|0.61|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
70878036|NCT02636868|141240092|SUPERIORITY|||||||0.414||||||A priori threshold of statistical significance set at 0.10|Regression, Linear|Generalized linear model using Poisson distribution with pooled site, treatment, gender, birth weight, and baseline FiO₂ in model.||Null hypothesis of no difference between treatment groups||||0.414
70878037|NCT02636868|141240093|SUPERIORITY|||||||0.099||||||A priori statistical significance of 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline fraction of inspired oxygen (FiO2) in model||Null hypothesis of no difference between treatment groups||||0.099
70878038|NCT02636868|141240093|SUPERIORITY|||||||0.09||||||A priori statistical significance of 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO2 in model||Null hypothesis of no difference between treatments||||0.090
70878039|NCT02636868|141240093|SUPERIORITY|||||||0.461||||||A priori statistical significance of 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO2 in model||Null hypothesis of no difference between treatment groups||||0.461
70958066|NCT00709852|141419872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63|STANDARD_DEVIATION|0.49|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
70958067|NCT00709852|141419873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65|STANDARD_DEVIATION|1.27|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
70958068|NCT00709852|141419873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.51|STANDARD_DEVIATION|1.01|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
70958069|NCT00709852|141419874|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.06||||||95.0|0.03|0.096|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for contrast enhancement||0.096|0.030|
70958070|NCT00709852|141419874|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.04||||||95.0|0.003|0.071|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for border delineation||0.071|0.003|
70958071|NCT00709852|141419874|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.03||||||95.0|0.003|0.055|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for internal morphology||0.055|0.003|
70958072|NCT00709852|141419875|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.01|STANDARD_DEVIATION|0.59||||95.0|-0.049|0.078|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||||0.078|-0.049|
70878040|NCT02636868|141240094|SUPERIORITY|||||||0.534||||||A priori threshold for statistical significance set at 0.05|ANOVA|treatment and pooled site in model||Null hypothesis of no treatment between treatments||||0.534
70878041|NCT02636868|141240094|SUPERIORITY|||||||0.48||||||A priori threshold for statistical significance set at 0.05|ANOVA|Treatment and pooled site in model||Null hypothesis of no difference between treatment groups||||0.480
70878042|NCT02636868|141240094|SUPERIORITY|||||||0.313||||||A priori threshold for statistical significance set at 0.05|ANOVA|Treatment and pooled site in model||Null hypothesis of no difference between treatment groups||||0.313
70878043|NCT02127567|141240186|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.1|||<|0.001|TWO_SIDED|95.0|1.5|2.7|||Mixed Models Analysis|||||2.7|1.5|<0.001
70878044|NCT02127567|141240187|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.8|||<|0.01|TWO_SIDED|95.0|1.1|4.4|||Mixed Models Analysis|||||4.4|1.1|<0.01
70878045|NCT02127567|141240188|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7||||0.44|TWO_SIDED|95.0|-0.7|2.0|||Mixed Models Analysis|||||2.0|-0.7|0.44
70878046|NCT02127567|141240189|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.2|||<|0.01|TWO_SIDED|95.0|0.8|3.6|||Mixed Models Analysis|||||3.6|0.8|<0.01
70878047|NCT02127567|141240190|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.8|||<|0.01|TWO_SIDED|95.0|0.7|2.9|||Mixed Models Analysis|||||2.9|0.7|<0.01
70878048|NCT02127567|141240191|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.78|TWO_SIDED|95.0|-2.0|1.3|||Mixed Models Analysis|||||1.3|-2.0|0.78
70878049|NCT02127567|141240192|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.4|||<|0.01|TWO_SIDED|95.0|4.1|6.7|||Mixed Models Analysis|||||6.7|4.1|<0.01
70878050|NCT02127567|141240193|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4||||0.002|TWO_SIDED|95.0|0.5|2.3|||Mixed Models Analysis|||||2.3|0.5|0.002
70878051|NCT03182829|141240236|NON_INFERIORITY|non-inferiority was chosen|Mean Difference (Final Values)|100.0|||<|0.05|TWO_SIDED|95.0|90.0|100.0|||Chi-squared||||Fisher's exact test|100|90|<0.05
70878052|NCT00254540|141240237|SUPERIORITY_OR_OTHER||Objective Response Rate(percentage)|48.0||||||95.0|27.8|68.7||||||||68.7|27.8|
70878053|NCT00254540|141240237|SUPERIORITY_OR_OTHER||Objective Response Rate(percentage)|46.2||||||95.0|26.6|66.6||||||||66.6|26.6|
70878054|NCT00225251|141240253|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.0|||<|0.05|||||||t-test, 2 sided|||||||<.05
70878055|NCT00786487|141240272|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
70878056|NCT00786487|141240272|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
70878057|NCT03060447|141240283|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 1: Day 2||||0.55
70878058|NCT03060447|141240283|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 1: Day 8||||0.54
70878059|NCT03060447|141240283|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 2: Day 1||||0.54
70878060|NCT03060447|141240283|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 2: Day 8||||0.54
70878061|NCT03060447|141240283|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 3: Day 1||||0.54
70878062|NCT03060447|141240283|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 3: Day 8||||0.57
70878063|NCT03060447|141240283|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 4: Day 1||||0.54
70878064|NCT03060447|141240283|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 4: Day 2||||0.52
70878065|NCT03060447|141240283|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 4: Day 4||||0.52
70878066|NCT03060447|141240283|SUPERIORITY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 4: Day 8||||0.61
70878067|NCT03060447|141240283|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 5: Day 1||||0.54
70878068|NCT03060447|141240283|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 5: Day 8||||0.52
70878069|NCT03060447|141240283|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 6: Day 1||||0.52
70878070|NCT03060447|141240283|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests||Dose 6: Day 4||||0.52
70878071|NCT03060447|141240283|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 6: Day 8||||0.52
70958073|NCT00709852|141419876|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.03||||||95.0|-0.009|0.065|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for contrast enhancement||0.065|-0.009|
70878072|NCT03060447|141240283|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 7: Day 1||||0.52
70878073|NCT03060447|141240283|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 7 - Day 8||||0.52
70878074|NCT03060447|141240283|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 8: Day 1||||0.52
70878075|NCT03060447|141240283|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 8: Day 8||||0.52
70878076|NCT03060447|141240283|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 9: Day 1||||0.52
70878077|NCT03060447|141240283|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests||Dose 9: Day 8||||1.00
70958074|NCT00709852|141419876|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|-0.01||||||95.0|-0.04|0.02|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for border delineation||0.020|-0.040|
70958075|NCT00709852|141419876|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.01||||||95.0|-0.015|0.035|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for internal morphology||0.035|-0.015|
70958076|NCT00709852|141419877|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.1||||||95.0|0.042|0.153|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for contrast enhancement||0.153|0.042|
70958077|NCT00709852|141419877|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.1||||||95.0|0.03|0.161|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for border delineation||0.161|0.030|
70958078|NCT00709852|141419877|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.05||||||95.0|0.006|0.098|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for internal morphology||0.098|0.006|
70958079|NCT00709852|141419878|SUPERIORITY_OR_OTHER||Difference|6.2||||0.0082|||||||McNemar|||||||0.0082
70958080|NCT00709852|141419879|SUPERIORITY_OR_OTHER||Difference|9.9|||<|0.0001|||||||McNemar|||||||< 0.0001
70958081|NCT00709852|141419880|SUPERIORITY_OR_OTHER||Difference|6.8||||0.0039|||||||McNemar|||||||0.0039
70878078|NCT03060447|141240283|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests||Dose 10: Day 1||||0.52
70878079|NCT03060447|141240283|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 10: Day 2||||0.52
70878080|NCT03060447|141240283|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 10: Day 4||||0.52
70878081|NCT03060447|141240283|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 10: Day 8||||0.52
70878082|NCT03060447|141240283|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 10: Day 14||||0.52
70958082|NCT00709852|141419881|SUPERIORITY_OR_OTHER||Difference|9.2|||<|0.0001|||||||McNemar|||||||< 0.0001
70958083|NCT00709852|141419882|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|-0.4||||||95.0|-3.8|2.9|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||2.9|-3.8|
70958084|NCT00709852|141419883|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|0.7||||||95.0|-0.3|1.6|||CI for paired percentages|lower limit of interval is compared to noninferiority margin||||1.6|-0.3|
70958085|NCT00709852|141419884|SUPERIORITY_OR_OTHER||Difference|10.5||||0.0002|||||||McNemar|||||||0.0002
70958086|NCT00709852|141419885|SUPERIORITY_OR_OTHER||Difference|13.6|||<|0.0001|||||||McNemar|||||||< 0.0001
70958087|NCT00709852|141419886|SUPERIORITY_OR_OTHER||Difference|0.0||||1|||||||McNemar|||||||1.0000
70958088|NCT00709852|141419887|SUPERIORITY_OR_OTHER||Difference|10.5||||0.0002|||||||McNemar|||||||0.0002
70958089|NCT00709852|141419888|SUPERIORITY_OR_OTHER||Difference|13.1||||0.0001|||||||McNemar|||||||0.0001
70958090|NCT00709852|141419889|SUPERIORITY_OR_OTHER||Difference|1.6||||0.763|||||||McNemar|||||||0.7630
70958091|NCT00709852|141419890|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|0.0||||||95.0|-3.1|3.1|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||3.1|-3.1|
70958092|NCT00709852|141419891|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|0.5||||||95.0|-2.7|3.6|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||3.6|-2.7|
70958093|NCT00709852|141419892|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|-1.6||||||95.0|-10.1|6.9|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||6.9|-10.1|
70958094|NCT00709852|141419893|SUPERIORITY_OR_OTHER||Difference|6.5||||0.0006|||||||McNemar|||||||0.0006
70958095|NCT00709852|141419894|SUPERIORITY_OR_OTHER||Difference|19.4||||0.0004|||||||McNemar|||||||0.0004
70958096|NCT00709852|141419895|SUPERIORITY_OR_OTHER||Difference|0.5||||0.6547|||||||McNemar|||||||0.6547
70958097|NCT00709852|141419896|SUPERIORITY_OR_OTHER||Difference|7.9|||<|0.0001|||||||McNemar|||||||< 0.0001
70958098|NCT00709852|141419897|SUPERIORITY_OR_OTHER||Difference|21.5|||<|0.0001|||||||McNemar|||||||< 0.0001
70958099|NCT00709852|141419898|SUPERIORITY_OR_OTHER||Difference|1.5||||0.0833|||||||McNemar|||||||0.0833
70958100|NCT00709852|141419899|SUPERIORITY_OR_OTHER||Difference|4.5||||0.0236|||||||McNemar|||||||0.0236
70958101|NCT00709852|141419900|SUPERIORITY_OR_OTHER||Difference|12.9||||0.0186|||||||McNemar|||||||0.0186
70878083|NCT03060447|141240284|SUPERIORITY|||||||0.035|||||||Log Rank|P-value between treatment groups was based on log-rank test.||≥ 50 Copies/mL||||0.035
70878084|NCT03060447|141240284|SUPERIORITY|||||||0.024|||||||Log Rank|P-value between treatment groups was based on log-rank test.||≥ 200 Copies/mL||||0.024
70878085|NCT03060447|141240285|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|P-values between treatment groups were based on Wilcoxon rank sum test.||||||0.67
70878086|NCT03060447|141240286|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|P-values between treatment groups were based on Wilcoxon rank sum test.||||||0.78
70878087|NCT03060447|141240287|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Baseline||||0.34
70878088|NCT03060447|141240287|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 1: Day 2||||0.11
70878089|NCT03060447|141240287|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 1: Day 8||||0.81
70878090|NCT03060447|141240287|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 4: Day 1||||0.83
70958102|NCT00709852|141419901|SUPERIORITY_OR_OTHER||Difference|0.5||||0.7055|||||||McNemar|||||||0.7055
70878091|NCT03060447|141240287|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 4: Day 2||||0.12
70878092|NCT03060447|141240287|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 4: Day 8||||0.45
70878093|NCT03060447|141240287|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 10: Day 1||||0.25
70878094|NCT03060447|141240287|SUPERIORITY|||||||0.053|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 10: Day 2||||0.053
70878095|NCT03060447|141240287|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 10: Day 8||||0.16
70878096|NCT03060447|141240287|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, ATI Remission Visit||||0.27
70878097|NCT03060447|141240287|SUPERIORITY|||||||0.35|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Baseline||||0.35
70878098|NCT03060447|141240287|SUPERIORITY|||||||0.013|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 1: Day 2||||0.013
70878099|NCT03060447|141240287|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 1: Day 8||||0.15
70958103|NCT00709852|141419902|SUPERIORITY_OR_OTHER||Difference|7.2|||<|0.0001|||||||McNemar|||||||< 0.0001
70878100|NCT03060447|141240287|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 4: Day 1||||0.30
70878101|NCT03060447|141240287|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 4: Day 2||||0.003
70878102|NCT03060447|141240287|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 4: Day 8||||0.49
70878103|NCT03060447|141240287|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 10: Day 1||||0.25
70878104|NCT03060447|141240287|SUPERIORITY|||||||0.055|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 10: Day 2||||0.055
70878105|NCT03060447|141240287|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 10: Day 8||||0.90
70878106|NCT03060447|141240287|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, ATI Remission Visit||||0.39
70878107|NCT03060447|141240287|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Baseline||||0.75
70878108|NCT03060447|141240287|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 1: Day 2||||<0.001
70958104|NCT00709852|141419903|SUPERIORITY_OR_OTHER||Difference|20.4|||<|0.0001|||||||McNemar|||||||< 0.0001
70878109|NCT03060447|141240287|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 1: Day 8||||0.69
70878110|NCT03060447|141240287|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 4: Day 1||||0.15
70878111|NCT03060447|141240287|SUPERIORITY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 4: Day 2||||0.018
70878112|NCT03060447|141240287|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 4: Day 8||||0.030
70878113|NCT03060447|141240287|SUPERIORITY|||||||0.087|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 10: Day 1||||0.087
70878114|NCT03060447|141240287|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 10: Day 2||||<0.001
70878115|NCT03060447|141240287|SUPERIORITY|||||||0.066|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 10: Day 8||||0.066
70878116|NCT03060447|141240287|SUPERIORITY|||||||0.86|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, ATI Remission||||0.86
70878117|NCT03060447|141240287|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Baseline||||0.19
70878118|NCT03060447|141240287|SUPERIORITY|||||||0.021|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 1: Day 2||||0.021
70878119|NCT03060447|141240287|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 1: Day 8||||0.31
70878120|NCT03060447|141240287|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 4: Day 1||||0.10
70878121|NCT03060447|141240287|SUPERIORITY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 4: Day 2||||0.018
70878122|NCT03060447|141240287|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 4: Day 8||||0.69
70878123|NCT03060447|141240287|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 10: Day 1||||0.46
70878124|NCT03060447|141240287|SUPERIORITY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 10: Day 2||||0.21
70878125|NCT03060447|141240287|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 10: Day 8||||0.67
70878126|NCT03060447|141240287|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, ATI Remission||||0.60
70878127|NCT03060447|141240288|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ISG15, Dose 1: Day 2||||0.002
70878128|NCT03060447|141240288|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ISG15, Dose 4: Day 1||||0.58
70878129|NCT03060447|141240288|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ISG15, Dose 4: Day 2||||0.009
70878130|NCT03060447|141240288|SUPERIORITY|ISG15, Dose 10: Day 1||||||0.031|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||||||0.031
70878131|NCT03060447|141240288|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ISG15, Dose 10: Day 2||||0.001
70878132|NCT03060447|141240288|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||OAS-1, Dose 1: Day 2||||0.003
70878133|NCT03060447|141240288|SUPERIORITY|||||||0.057|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||OAS-1, Dose 4: Day 1||||0.057
70878134|NCT03060447|141240288|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||OAS-1, Dose 4: Day 2||||0.009
70878135|NCT03060447|141240288|SUPERIORITY|||||||0.057|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||OAS-1, Dose 10: Day 1||||0.057
70878136|NCT03060447|141240288|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||OAS-1, Dose 10: Day 2||||0.005
70878137|NCT03060447|141240288|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||MX1, Dose 1: Day 2||||<0.001
70878138|NCT03060447|141240288|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||MX1, Dose 4: Day 1||||0.17
70878139|NCT03060447|141240288|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||MX1, Dose 4: Day 2||||0.003
70878140|NCT03060447|141240288|SUPERIORITY|MX1, Dose 10: Day 1||||||0.1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||||||0.100
70878141|NCT03060447|141240288|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||MX1, Dose 10: Day 2||||<0.001
70878142|NCT03060447|141240289|SUPERIORITY|||||||0.7469|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Baseline||||0.7469
70878143|NCT03060447|141240289|SUPERIORITY|||||||0.1207|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 4: Day 1||||0.1207
70878144|NCT03060447|141240289|SUPERIORITY|||||||0.4113|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 4: Day 2||||0.4113
70878145|NCT03060447|141240289|SUPERIORITY|||||||0.1113|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 4: Day 4||||0.1113
70958105|NCT00709852|141419904|SUPERIORITY_OR_OTHER||Difference|1.0||||0.1573|||||||McNemar|||||||0.1573
70958106|NCT00709852|141419905|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|2.1||||||95.0|0.2|3.9|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||3.9|0.2|
70958107|NCT00709852|141419906|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|6.5||||||95.0|1.5|11.4|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||11.4|1.5|
70958108|NCT00709852|141419907|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|0.0||||||95.0|-1.4|1.4|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||1.4|-1.4|
70958109|NCT00709852|141419908|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|0.7||||||95.0|-0.3|1.6|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||1.6|-0.3|
70958110|NCT00709852|141419909|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|1.1||||||95.0|-1.0|3.2|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||3.2|-1.0|
70958111|NCT00709852|141419910|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|0.5||||||95.0|-0.5|1.5|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||1.5|-0.5|
70958112|NCT00709852|141419911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57|STANDARD_DEVIATION|0.56|<|0.0001|||||||paired t test|||||||< 0.0001
70958113|NCT00709852|141419912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57|STANDARD_DEVIATION|0.58|<|0.0001|||||||paired t test|||||||< 0.0001
70958114|NCT00709852|141419913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.48||||||||||||||||
70958115|NCT00709852|141419914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.76|STANDARD_DEVIATION|0.93|<|0.0001|||||||paired t test|||||||< 0.0001
70958116|NCT00709852|141419915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73|STANDARD_DEVIATION|0.89|<|0.0001|||||||paired t test|||||||< 0.0001
70958117|NCT00709852|141419916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.39||||||||||||||||
70958118|NCT00709852|141419917|SUPERIORITY_OR_OTHER||||||<|0.0001||||||for all three readers|t-test, 2 sided|||||||< 0.0001
70878146|NCT03060447|141240289|SUPERIORITY|||||||0.241|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 6: Day 1||||0.2410
70958119|NCT00709852|141419919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|1.06||||||||||||||||
70958120|NCT00709852|141419920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_DEVIATION|26.6||||||||||||||||
70958121|NCT00825825|141419985|SUPERIORITY_OR_OTHER|||||||0.000704||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the escitalopram and citalopram medication periods.||||0.000704
70878147|NCT03060447|141240289|SUPERIORITY|||||||0.1098|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 6: Day 4||||0.1098
70878148|NCT03060447|141240289|SUPERIORITY|||||||0.0369|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 10: Day 1||||0.0369
70878149|NCT03060447|141240289|SUPERIORITY|||||||0.0814|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 10: Day 2||||0.0814
70878150|NCT03060447|141240289|SUPERIORITY|||||||0.1658|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 10: Day 4||||0.1658
70958122|NCT00825825|141419986|SUPERIORITY_OR_OTHER|||||||1.62e-05||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the escitalopram and citalopram medication periods.||||0.0000162
70958123|NCT00825825|141419987|SUPERIORITY_OR_OTHER|||||||9.36e-06||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the citalopram and placebo medication periods.||||0.00000936
70958124|NCT00825825|141419988|SUPERIORITY_OR_OTHER|||||||0.0279||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the citalopram and placebo medication periods.||||0.0279
70958125|NCT00825825|141419989|SUPERIORITY_OR_OTHER|||||||0.00124||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the escitalopram and placebo medication periods.||||0.00124
70958126|NCT00825825|141419990|SUPERIORITY_OR_OTHER|||||||6.33e-05||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the placebo and citalopram medication periods.||||0.0000633
70958127|NCT00825825|141419991|SUPERIORITY_OR_OTHER|||||||0.0241||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the escitalopram and citalopram medication periods.||||0.0241
70958128|NCT01043393|141420033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.779|||||TWO_SIDED|95.0|0.055|11.126||||||||11.126|0.055|
70958129|NCT00112047|141420088|NON_INFERIORITY_OR_EQUIVALENCE|Assuming 70% response rate for each group at Week 48, 500 participants (250 per group) were sufficient to achieve at least 85% power to establish non-inferiority between the 2 study groups with a delta of 13%. The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in percentages|11.4||||0.002|TWO_SIDED|95.0|4.3|18.6||The difference and 95% CI are stratum-weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the percentage of responders (who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 48 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the percentage of responders who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 48 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."||18.6|4.3|0.002
70958130|NCT00112047|141420089|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in percentages|9.1||||0.021|TWO_SIDED|95.0|1.6|16.6||The difference and 95% CI are stratum-weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the percentage of responders (who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 48 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the percentage of responders who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 48 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."||16.6|1.6|0.021
70958131|NCT00112047|141420090|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in percentages|11.2||||0.004|TWO_SIDED|95.0|3.7|18.6||The difference and 95% CI are stratum-weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made||Null hypothesis: The percentage of participants with HIV-1 RNA \< 400 c/mL at Week 48 in the EFV+FTC+TDF group is more than 13% worse than the CBV+EFV group. Alternative hypothesis: The percentage of participants with HIV-1 RNA \< 400 c/mL at Week 48 in the EFV+FTC+TDF group is no more than 13% worse than the CBV+EFV group.||18.6|3.7|0.004
70958132|NCT00112047|141420091|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in percentages|7.9||||0.058|TWO_SIDED|95.0|0.1|15.6||The difference and 95% CI are stratum-weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||Null hypothesis: The percentage of participants with HIV-1 RNA \< 50 c/mL at Week 48 in the EFV+FTC+TDF group is more than 13% worse than the CBV+EFV group. Alternative hypothesis: The percentage of participants with HIV-1 RNA \< 50 c/mL at Week 48 in the EFV+FTC+TDF group is no more than 13% worse than the CBV+EFV group.||15.6|0.1|0.058
70958133|NCT00112047|141420092|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||The distribution of time to loss-of-virologic response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with Loss of Virologic Response through Week 48 is equal between the two treatment groups. Alternative hypothesis: The percentage of participants with Loss of Virologic Response through Week 48 is different between the two treatment groups.||||0.003
70958134|NCT00112047|141420093|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||The distribution of time to loss-of-virologic response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null hypothesis: The percentage of participants with Loss of Virologic Response through Week 48 is equal between the two treatment groups. Alternative hypothesis: The percentage of participants with Loss of Virologic Response through Week 48 is different between the two treatment groups.||||0.046
70958135|NCT00112047|141420094|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 48 is equal for the 2 treatment groups. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 48 is different between the 2 treatment groups.||||0.026
70958136|NCT00112047|141420095|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 50 c/mL) through Week 48 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 50 c/mL) through Week 48 for the EFV+FTC+TDF and CBV+EFV groups are different.||||0.063
70958137|NCT00112047|141420096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.31|TWO_SIDED|95.0|-0.16|0.06||The change from baseline to Week 48 in HIV-1 RNA was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from stratum-weighted Van Elteren test.|Van Elteren|No other adjustments were made.||Null Hypothesis: Changes from baseline through Week 48 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are different.||0.06|-0.16|0.31
70958138|NCT00112047|141420097|SUPERIORITY_OR_OTHER||stratum-weighted difference|31.74||||0.002||95.0|8.96|54.52||The change from baseline to Week 48 in HIV-1 RNA was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from stratum weighted Van Elteren test.|Van Elteren|No other adjustments were made.||Null Hypothesis: Changes from baseline through Week 48 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are different.||54.52|8.96|0.002
70958139|NCT00112047|141420098|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in percentages|12.7||||0.004|TWO_SIDED|95.0|4.3|21.1||The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from Cochran-Mantel-Haenszel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the percentage of responders (who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 96 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the percentage of responders who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 96 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."||21.1|4.3|0.004
70958140|NCT00112047|141420099|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in proportions|6.4||||0.158|TWO_SIDED|95.0|-2.3|15.0||The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from Cochran-Mantel-Haenszel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the percentage of responders (who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 96 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the percentage of responders who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 96 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."||15.0|-2.3|0.158
70958141|NCT00112047|141420100|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||The distribution of time to loss-of-virologic response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: Ther percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 400 c/mL) at Week 96 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 400 c/mL) at Week 96 for the EFV+FTC+TDF and CBV+EFV groups are different||||0.003
70958142|NCT00112047|141420101|SUPERIORITY_OR_OTHER|||||||0.124||95.0||||The distribution of time to loss-of-virologic response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 50 c/mL) through Week 96 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 50 c/mL) through Week 96 for the EFV+FTC+TDF and CBV+EFV groups are different||||0.124
70958143|NCT00112047|141420102|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 96 is equal for the 2 treatment groups. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 96 is different between the 2 treatment groups.||||0.025
70958144|NCT00112047|141420103|SUPERIORITY_OR_OTHER|||||||0.41||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (HIV-1 RNA \< 50 c/mL) through Week 96 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with pure virological failure (HIV-1 RNA \< 50 c/mL) through Week 96 for the EFV+FTC+TDF and CBV+EFV groups are different||||0.41
70878151|NCT03060447|141240289|SUPERIORITY|||||||0.9431|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 10: Day 14||||0.9431
70958145|NCT00112047|141420104|SUPERIORITY_OR_OTHER||stratum-weighted difference|-0.05||||0.45||95.0|-0.17|0.08||The change from baseline to Week 96 in HIV-1 RNA was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference.|Van Elteren|No other adjustments were made.||Null Hypothesis: Changes from baseline through Week 96 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline through Week 96 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are different.||0.08|-0.17|0.45
70958146|NCT00112047|141420105|SUPERIORITY_OR_OTHER||stratum-weighted difference|32.93||||0.036||95.0|0.87|64.99||The change from baseline to Week 96 in CD4 cell count was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from stratum weighted Van Elteren test.|Van Elteren|No other adjustments were made.||Null Hypothesis: Changes from baseline through Week 96 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline through Week 96 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are different.||64.99|0.87|0.036
70958147|NCT00112047|141420106|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The change from Week 48 to Week 96 in limb fat was compared between the 2 treatment groups; the P-value is from the Wilcoxon Rank Sum Test.|Wilcoxon Rank Sum Test|No other adjustments were made.||Null Hypothesis: Change from Week 48 to Week 96 in limb fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Change from Week 48 to Week 96 in limb fat for the EFV+FTC+TDF and CBV+EFV groups are not equal||||<0.001
70958148|NCT00112047|141420107|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||The change from Week 48 to Week 96 in trunk fat was compared between the 2 treatment groups; the P-value is from the Wilcoxon Rank Sum Test.|Wilcoxon Rank Sum test|No other adjustments were made.||Null Hypothesis: Changes from Week 48 to Week 96 in Trunk Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 to Week 96 in Trunk Fat for the EFV+FTC+TDF and CBV+EFV groups are different||||0.025
70958149|NCT00112047|141420108|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The change from Week 48 to Week 96 in trunk fat was compared between the 2 treatment groups; the P-value is from the Wilcoxon Rank Sum Test.|Wilcoxon Rank Sum test|No other adjustments were made.||Null Hypothesis: Changes from Week 48 to Week 96 in Total Body Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 to Week 96 in Total Body Fat for the EFV+FTC+TDF and CBV+EFV groups are different||||<0.001
70958150|NCT00112047|141420109|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in proportions|12.9||||0.004|TWO_SIDED|95.0|4.2|21.6||The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from Cochran-Mantel-Haenzel test.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the proportion of responders (who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 144 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the proportion of responders who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 144 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."||21.6|4.2|0.004
70958151|NCT00112047|141420110|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in proportions|8.1||||0.082|TWO_SIDED|95.0|-0.8|17.0||The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenszel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the proportion of responders (who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 144 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the proportion of responders who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 144 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."||17.0|-0.8|0.082
70958152|NCT00112047|141420111|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in proportions|11.6||||0.009||95.0|3.1|20.1||The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||Null Hypothesis: The percentage of participants with HIV-1 RNA \< 400 c/mL at Week 144 in the EFV+FTC+TDF group is more than 13% worse than the CBV+EFV group. Alternative hypothesis: The percentage of participants with HIV-1 RNA \< 400 c/mL at Week 144 in the EFV+FTC+TDF group is no more than 13% worse than the CBV+EFV group.||20.1|3.1|0.009
70878152|NCT03060447|141240289|SUPERIORITY|||||||0.6514|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Baseline||||0.6514
70878153|NCT03060447|141240289|SUPERIORITY|||||||0.0821|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 4: Day 1||||0.0821
70878154|NCT03060447|141240289|SUPERIORITY|||||||0.2353|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 4: Day 2||||0.2353
70878155|NCT03060447|141240289|SUPERIORITY|||||||0.1779|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 4: Day 4||||0.1779
70878156|NCT03060447|141240289|SUPERIORITY|||||||0.7491|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 6: Day 1||||0.7491
70878157|NCT03060447|141240289|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 6: Day 4||||0.0700
70878158|NCT03060447|141240289|SUPERIORITY|||||||0.3711|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 10: Day 1||||0.3711
70878159|NCT03060447|141240289|SUPERIORITY|||||||0.0814|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 10: Day 2||||0.0814
70878160|NCT03060447|141240289|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 10: Day 4||||0.0700
70878161|NCT03060447|141240289|SUPERIORITY|||||||0.8303|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 10: Day 14||||0.8303
70878162|NCT03060447|141240289|SUPERIORITY|||||||0.953|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Baseline||||0.9530
70878163|NCT03060447|141240289|SUPERIORITY|||||||0.1735|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 4: Day 1||||0.1735
70878164|NCT03060447|141240289|SUPERIORITY|||||||0.2971|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 4: Day 2||||0.2971
70878165|NCT03060447|141240289|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 4: Day 4||||1.0000
70878166|NCT03060447|141240289|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 6: Day 1||||1.0000
70878167|NCT03060447|141240289|SUPERIORITY|||||||0.3374|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 6: Day 4||||0.3374
70878168|NCT03060447|141240289|SUPERIORITY|||||||0.7656|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 10: Day 1||||0.7656
70878169|NCT03060447|141240289|SUPERIORITY|||||||0.0814|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 10: Day 2||||0.0814
70878170|NCT03060447|141240289|SUPERIORITY|||||||0.3374|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 10: Day 4||||0.3374
70878171|NCT03060447|141240289|SUPERIORITY|||||||0.432|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 10: Day 14||||0.4320
70878172|NCT03060447|141240289|SUPERIORITY|||||||0.8597|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Baseline||||0.8597
70878173|NCT03060447|141240289|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 4: Day 1||||1.0000
70878174|NCT03060447|141240289|SUPERIORITY|||||||0.0306|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 4: Day 2||||0.0306
70878175|NCT03060447|141240289|SUPERIORITY|||||||0.8345|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 4: Day 4||||0.8345
70878176|NCT03060447|141240289|SUPERIORITY|||||||0.9151|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 6: Day 1||||0.9151
70878177|NCT03060447|141240289|SUPERIORITY|||||||0.1098|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 6: Day 4||||0.1098
70878178|NCT03060447|141240289|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 10: Day 1||||1.0000
70878179|NCT03060447|141240289|SUPERIORITY|||||||0.0814|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 10: Day 2||||0.0814
70878180|NCT03060447|141240289|SUPERIORITY|||||||0.4555|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 10: Day 4||||0.4555
70878181|NCT03060447|141240289|SUPERIORITY|||||||0.6171|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 10: Day 14||||0.6171
70878182|NCT03060447|141240289|SUPERIORITY|||||||0.0677|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Baseline||||0.0677
70878183|NCT03060447|141240289|SUPERIORITY|||||||0.4712|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 4: Day 1||||0.4712
70878184|NCT03060447|141240289|SUPERIORITY|||||||0.6889|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 4: Day 2||||0.6889
70878185|NCT03060447|141240289|SUPERIORITY|||||||0.1437|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 4: Day 4||||0.1437
70878186|NCT03060447|141240289|SUPERIORITY|||||||0.7491|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 6: Day 1||||0.7491
70878187|NCT03060447|141240289|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 6: Day 4||||0.0700
70878188|NCT03060447|141240289|SUPERIORITY|||||||0.7656|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 10: Day 1||||0.7656
70878189|NCT03060447|141240289|SUPERIORITY|||||||0.1752|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 10: Day 2||||0.1752
70878190|NCT03060447|141240289|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 10: Day 4||||0.0700
70878191|NCT03060447|141240289|SUPERIORITY|CD69+CD56brCD16dim, Dose 10: Day 14||||||0.2246|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||||||0.2246
70958153|NCT00112047|141420112|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in proportions|10.4||||0.019|TWO_SIDED|95.0|1.8|19.0||The p-value for the superiority test is from Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||Null hypothesis: The percentage of participants with HIV-1 RNA \< 50 c/mL at Week 144 in the EFV+FTC+TDF group is more than 13% worse than the CBV+EFV group. Alternative hypothesis: The percentage of participants with HIV-1 RNA \< 50 c/mL at Week 144 in the EFV+FTC+TDF group is no more than 13% worse than the CBV+EFV group.||19.0|1.8|0.019
70958154|NCT00112047|141420113|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||The distribution of loss of virological response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 400 c/mL) through Week 144 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 400 c/mL) through Week 144 for the EFV+FTC+TDF and CBV+EFV groups are different||||0.003
70878192|NCT03274440|141240298|OTHER|A random-effects linear mixed model evaluated changes in YBOCCS as a function of condition (THC, CBD, placebo \[PBO\]), time point, and their interaction.||||||0.577|||||||Linear mixed effects regression|||Test for interaction effect between condition and time (includes all three groups and all time points)||||.577
70878193|NCT03274440|141240298|OTHER|A random-effects linear mixed model evaluated changes in YBOCCS as a function of condition (THC, CBD, placebo \[PBO\]), time point, and their interaction.|||||<|0.001|||||||Linear mixed effects regression|F=10.50; df=6, 10||Test for main effect of time (includes all three groups and all time points)||||<.001
70878194|NCT03274440|141240298|OTHER|A random-effects linear mixed model evaluated changes in YBOCCS as a function of condition (THC, CBD, placebo \[PBO\]), time point, and their interaction.||||||0.72|||||||Linear mixed effects regression|||Test for main effect of condition (includes all three groups and all time points)||||.72
70878195|NCT03274440|141240299|OTHER|A random-effects linear mixed model evaluated changes in STAI-S as a function of condition (THC, CBD, placebo \[PBO\]), time point, and their interaction.||||||0.577|||||||Linear mixed effects regression|||Test for interaction between condition and time||||.577
70878196|NCT03274440|141240299|OTHER|A random-effects linear mixed model evaluated changes in STAI-S as a function of condition (THC, CBD, placebo \[PBO\]), time point, and their interaction.|||||<|0.001|||||||Linear mixed effects regression|F=7.00, df=6,10||Test for main effect of time||||<.001
70878197|NCT03274440|141240299|OTHER|A random-effects linear mixed model evaluated changes in STAI-S as a function of condition (THC, CBD, placebo \[PBO\]), time point, and their interaction.||||||0.002|||||||Linear mixed effects regression|F=6.26, df=2, 10||Test for main effect of condition||||.002
70878198|NCT04249310|141240328|OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.32|2.46|||||\[(Tiotropium/Olodaterol) / Tiotropium\] Cox-regression was used to estimate the hazard ratios and 95% confidence intervals.|||2.46|0.32|
70958155|NCT00112047|141420114|SUPERIORITY_OR_OTHER|||||||0.056||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 50 c/mL) through Week 144 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 50 c/mL) through Week 144 for the EFV+FTC+TDF and CBV+EFV groups are different||||0.056
70878199|NCT04249310|141240329|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.63|1.15|||||\[(Tiotropium/Olodaterol) / Tiotropium\] Cox regression was used to estimate the hazard ratios and 95% confidence intervals.|Moderate or Severe COPD Exacerbation||1.15|0.63|
70878200|NCT04249310|141240329|OTHER||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.43|1.01|||||\[(Tiotropium/Olodaterol) / Tiotropium\] Cox regression was used to estimate the hazard ratios and 95% confidence intervals.|Moderate COPD Exacerbation||1.01|0.43|
70878201|NCT04249310|141240329|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.62|1.31|||||\[(Tiotropium/Olodaterol) / Tiotropium\] Cox regression was used to estimate the hazard ratios and 95% confidence intervals.|Severe COPD Exacerbation||1.31|0.62|
70878202|NCT01928329|141240393|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.13||0.0816|TWO_SIDED|95.0|-0.5|0.03||The \<0.05 is the apriori threshold for statistical significance.|Mixed Models Analysis|HbA1c Linear Mixed Model Results (adjusts the model for: baseline BMI, gender, study site, race (White/Non White) and Baseline C-Peptide production).||||0.03|-0.50|0.0816
70878203|NCT01928329|141240394|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.13||0.912|TWO_SIDED|95.0|-0.28|0.25||The \<0.05 is the apriori threshold for statistical significance.|Mixed Models Analysis|HbA1c Linear Mixed Model Results (adjusts the model for: baseline BMI, gender, study site, race (White/Non White) and Baseline C-Peptide production).||||0.25|-0.28|0.912
70878204|NCT01928329|141240395|SUPERIORITY||Z score|-0.801||||0.423|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.423
70878205|NCT01928329|141240396|SUPERIORITY||Z score|-1.312||||0.189|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.189
70878206|NCT05167734|141240403|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.02|TWO_SIDED|95.0|0.1|1.2|||Mixed Models Analysis|linear mixed effects model adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|values greater than 0 infer higher hemoglobin in active intervention|||1.2|0.1|0.02
70878207|NCT05167734|141240404|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.04|TWO_SIDED|95.0|0.0|1.1|||Mixed Models Analysis|linear mixed effects model adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|adjusted mean difference|3-months post hospitalization||1.1|0.0|0.04
70878208|NCT05167734|141240404|SUPERIORITY||Mean Difference (Net)|0.2||||0.42|TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|linear mixed effects model adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission||Hospital Discharge||0.7|-0.3|0.42
70878209|NCT05167734|141240405|SUPERIORITY|||||||0.352|||||||Mixed Models Analysis|||||||0.352
70878210|NCT05167734|141240406|SUPERIORITY||||||<|0.001||||||threshold for significance - p\<0.05|Mixed Models Analysis|||||||<0.001
70878211|NCT05167734|141240407|SUPERIORITY||Odds Ratio (OR)|1.03||||0.94|TWO_SIDED|95.0|0.44|2.4|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|Hospital Discharge||2.40|0.44|0.94
70878212|NCT05167734|141240407|SUPERIORITY||Odds Ratio (OR)|1.79||||0.18|TWO_SIDED|95.0|0.76|4.2|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|1-month post hospitalization||4.20|0.76|0.18
70878213|NCT05167734|141240407|SUPERIORITY||Odds Ratio (OR)|1.23||||0.64|TWO_SIDED|95.0|0.51|3.0|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|3-months post hospitalization||3.00|0.51|0.64
70958156|NCT00112047|141420115|SUPERIORITY_OR_OTHER|||||||0.066||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 144 is equal for the 2 treatment groups. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 144 is different between the 2 treatment groups||||0.066
70958157|NCT00112047|141420116|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 50 c/mL) at Week 144 is equal for the 2 treatment groups. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 50 c/mL) at Week 144 is different between the 2 treatment groups||||0.30
70958158|NCT00112047|141420117|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.39|TWO_SIDED|95.0|-0.16|0.08||The change from baseline to Week 144 in HIV-1 RNA was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from a stratum weighted Van Elteren test.|Van Elteren|No other adjustments were made||Null Hypothesis: Changes from baseline to Week 144 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline to Week 144 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are different.||0.08|-0.16|0.39
70878214|NCT05167734|141240408|SUPERIORITY||Odds Ratio (OR)|1.81||||0.23|TWO_SIDED|95.0|0.68|4.8|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|Hospital discharge||4.80|0.68|0.23
70878215|NCT05167734|141240408|SUPERIORITY||Odds Ratio (OR)|2.43||||0.09|TWO_SIDED|95.0|0.87|6.8|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|1-month post hospitalization||6.80|0.87|0.09
70878216|NCT05167734|141240408|SUPERIORITY||Odds Ratio (OR)|2.52||||0.084|TWO_SIDED|95.0|0.88|7.2|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|3-months post hospitalization||7.20|0.88|0.084
70878217|NCT05167734|141240409|SUPERIORITY||Mean Difference (Net)|218.0||||0.13|TWO_SIDED|95.0|-73.0|510.0|||Mixed Models Analysis|adjusting for baseline hemoglobin, age, sex, surgical vs. non-surgical admission, and baseline ADLs|scores greater than 0 reflect greater ambulatory distance in active intervention|1-month post hospitalization||510|-73|0.13
70958159|NCT00112047|141420118|SUPERIORITY_OR_OTHER||Mean Difference (Net)|41.3||||0.089|TWO_SIDED|95.0|4.05|78.55||The change from baseline to Week 144 in CD4 cell count was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from a stratum weighted Van Elteren test.|Van Elteren|No other adjustments were made||Null Hypothesis: Changes from baseline toWeek 144 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline to Week 144 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are different.||78.55|4.05|0.089
70878218|NCT05167734|141240409|SUPERIORITY||Median Difference (Net)|178.0||||0.27|TWO_SIDED|95.0|-154.0|510.0|||Mixed Models Analysis|adjusting for baseline hemoglobin, age, sex, surgical vs. non-surgical admission, baseline ADLs||3-months post hospitalization||510|-154|0.27
70878219|NCT05167734|141240410|SUPERIORITY||Odds Ratio (OR)|2.49||||0.12|TWO_SIDED|95.0|0.79|7.8|||proportional odds|adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|1-month post hospitalization||7.80|0.79|0.12
70878220|NCT05167734|141240410|SUPERIORITY||Odds Ratio (OR)|3.1||||0.07|TWO_SIDED|95.0|0.91|10.5|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|3-months post hospitalization||10.5|0.91|0.07
70878221|NCT05167734|141240411|SUPERIORITY||Odds Ratio (OR)|0.5||||0.29|TWO_SIDED|95.0|0.14|1.8|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|1-month post hospitalization for anxiety score||1.80|0.14|0.29
70878222|NCT05167734|141240411|SUPERIORITY||Odds Ratio (OR)|0.68||||0.57|TWO_SIDED|95.0|0.18|2.6|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|3-months post hospitalization for anxiety score||2.60|0.18|0.57
70878223|NCT05167734|141240411|SUPERIORITY||Odds Ratio (OR)|0.36||||0.12|TWO_SIDED|95.0|0.1|1.3|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|1-month post hospitalization for depression score||1.30|0.10|0.12
70878224|NCT05167734|141240411|SUPERIORITY||Odds Ratio (OR)|0.62||||0.48|TWO_SIDED|95.0|0.16|2.4|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|3-months post hospitalization for depression score||2.40|0.16|0.48
70878225|NCT05167734|141240412|SUPERIORITY||Odds Ratio (OR)|1.48||||0.56|TWO_SIDED|95.0|0.39|5.6|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|1-month post hospitalization||5.60|0.39|0.56
70878226|NCT05167734|141240412|SUPERIORITY||Odds Ratio (OR)|9.16||||0.02|TWO_SIDED|95.0|1.4|59.9|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|3-months post hospitalization||59.9|1.40|0.02
70878227|NCT05167734|141240413|SUPERIORITY||Odds Ratio (OR)|0.16||||0.09|TWO_SIDED|95.0|0.02|1.4|||Regression, Logistic|adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|||1.40|0.02|0.09
70878228|NCT05167734|141240415|SUPERIORITY||Odds Ratio (OR)|0.73||||0.48|TWO_SIDED|95.0|0.3|1.8|||Regression, Logistic|logistic models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds for the given event associated with intervention associated with active intervention|3-months post hospitalization||1.80|0.30|0.48
70878229|NCT05167734|141240416|SUPERIORITY||Odds Ratio (OR)|2.13||||0.54|TWO_SIDED|95.0|0.19|24.0|||Regression, Logistic|logistic models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds for the given event associated with intervention associated with active intervention|3-months post hospitalization||24.0|0.19|0.54
70878230|NCT02604212|141240420|SUPERIORITY||LS Mean Difference|-0.042|STANDARD_ERROR_OF_MEAN|0.102||0.6815|TWO_SIDED|95.0|-0.243|0.159|||MMRM|||||0.159|-0.243|0.6815
70878231|NCT02604212|141240420|SUPERIORITY||LS Mean Difference|-0.438|STANDARD_ERROR_OF_MEAN|0.101|<|0.0001|TWO_SIDED|95.0|-0.638|-0.237|||MMRM|||||-0.237|-0.638|<.0001
70878232|NCT02604212|141240420|SUPERIORITY||LS Mean Difference|-0.396|STANDARD_ERROR_OF_MEAN|0.088|<|0.0001|TWO_SIDED|95.0|-0.569|-0.223|||MMRM|||||-0.223|-0.569|<.0001
70878233|NCT02604212|141240421|SUPERIORITY||LS Mean Difference|-0.208|STANDARD_ERROR_OF_MEAN|0.083||0.0131|TWO_SIDED|95.0|-0.372|-0.044|||MMRM|||Day 15||-0.044|-0.372|0.0131
70878234|NCT02604212|141240421|SUPERIORITY||LS Mean Difference|-0.247|STANDARD_ERROR_OF_MEAN|0.084||0.0036|TWO_SIDED|95.0|-0.412|-0.082|||MMRM|||Day 15||-0.082|-0.412|0.0036
70878235|NCT02604212|141240421|SUPERIORITY||LS Mean Difference|-0.039|STANDARD_ERROR_OF_MEAN|0.077||0.6136|TWO_SIDED|95.0|-0.192|0.113|||MMRM|||Day 15||0.113|-0.192|0.6136
70878236|NCT02604212|141240421|SUPERIORITY||LS Mean Difference|-0.085|STANDARD_ERROR_OF_MEAN|0.083||0.3104|TWO_SIDED|95.0|-0.249|0.08|||MMRM|||Day 29||0.080|-0.249|0.3104
70878237|NCT02604212|141240421|SUPERIORITY||LS Mean Difference|-0.174|STANDARD_ERROR_OF_MEAN|0.084||0.0401|TWO_SIDED|95.0|-0.34|-0.008|||MMRM|||Day 29||-0.008|-0.340|0.0401
70878238|NCT02604212|141240421|SUPERIORITY||LS Mean Difference|-0.089|STANDARD_ERROR_OF_MEAN|0.077||0.2494|TWO_SIDED|95.0|-0.242|0.063|||MMRM|||Day 29||0.063|-0.242|0.2494
70878239|NCT02604212|141240421|SUPERIORITY||LS Mean Difference|-0.211|STANDARD_ERROR_OF_MEAN|0.085||0.0149|TWO_SIDED|95.0|-0.38|-0.042|||MMRM|||Day 43||-0.042|-0.380|0.0149
70878240|NCT02604212|141240421|SUPERIORITY||LS Mean Difference|-0.319|STANDARD_ERROR_OF_MEAN|0.086||0.0003|TWO_SIDED|95.0|-0.489|-0.149|||MMRM|||Day 43||-0.149|-0.489|0.0003
70878241|NCT02604212|141240421|SUPERIORITY||LS Mean Difference|-0.108|STANDARD_ERROR_OF_MEAN|0.078||0.1655|TWO_SIDED|95.0|-0.262|0.045|||MMRM|||Day 29||0.045|-0.262|0.1655
70878242|NCT02604212|141240421|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.088||0.0889|TWO_SIDED|95.0|-0.324|0.023|||MMRM|||Day 57||0.023|-0.324|0.0889
70878243|NCT02604212|141240421|SUPERIORITY||LS Mean Difference|-0.322|STANDARD_ERROR_OF_MEAN|0.088||0.0004|TWO_SIDED|95.0|-0.497|-0.147|||MMRM|||Day 57||-0.147|-0.497|0.0004
70878244|NCT02604212|141240421|SUPERIORITY||LS Mean Difference|-0.172|STANDARD_ERROR_OF_MEAN|0.078||0.0298|TWO_SIDED|95.0|-0.326|-0.017|||MMRM|||Day 57||-0.017|-0.326|0.0298
70878245|NCT02604212|141240421|SUPERIORITY||LS Mean Difference|-0.184|STANDARD_ERROR_OF_MEAN|0.089||0.0415|TWO_SIDED|95.0|-0.361|-0.007|||MMRM|||Day 71||-0.007|-0.361|0.0415
70878246|NCT02604212|141240421|SUPERIORITY||LS Mean Difference|-0.441|STANDARD_ERROR_OF_MEAN|0.091|<|0.0001|TWO_SIDED|95.0|-0.62|-0.261|||MMRM|||Day 71||-0.261|-0.620|<.0001
70878247|NCT02604212|141240421|SUPERIORITY||LS Mean Difference|-0.257|STANDARD_ERROR_OF_MEAN|0.079||0.0015|TWO_SIDED|95.0|-0.413|-0.1|||MMRM|||Day 71||-0.100|-0.413|0.0015
70878248|NCT02604212|141240421|SUPERIORITY||LS Mean Difference|-0.086|STANDARD_ERROR_OF_MEAN|0.092||0.351|TWO_SIDED|95.0|-0.268|0.096|||MMRM|||Day 85||0.096|-0.268|0.3510
70878249|NCT02604212|141240421|SUPERIORITY||LS Mean Difference|-0.404|STANDARD_ERROR_OF_MEAN|0.094|<|0.0001|TWO_SIDED|95.0|-0.59|-0.219|||MMRM|||Day 85||-0.219|-0.590|<.0001
70878250|NCT02604212|141240421|SUPERIORITY||LS Mean Difference|-0.318|STANDARD_ERROR_OF_MEAN|0.082||0.0002|TWO_SIDED|95.0|-0.481|-0.156|||MMRM|||Day 85||-0.156|-0.481|0.0002
70878251|NCT02604212|141240421|SUPERIORITY||LS Mean Difference|-0.151|STANDARD_ERROR_OF_MEAN|0.096||0.1198|TWO_SIDED|95.0|-0.341|0.04|||MMRM|||Day 99||0.040|-0.341|0.1198
70878252|NCT02604212|141240421|SUPERIORITY||LS Mean Difference|-0.516|STANDARD_ERROR_OF_MEAN|0.097|<|0.0001|TWO_SIDED|95.0|-0.708|-0.325|||MMRM|||Day 99||-0.325|-0.708|<.0001
70878253|NCT02604212|141240421|SUPERIORITY||LS Mean Difference|-0.366|STANDARD_ERROR_OF_MEAN|0.085|<|0.0001|TWO_SIDED|95.0|-0.535|-0.197|||MMRM|||Day 99||-0.197|-0.535|<.0001
70878254|NCT02604212|141240422|SUPERIORITY|||||||0.0867|||||||Fisher Exact|||||||0.0867
70878255|NCT02604212|141240422|SUPERIORITY|||||||0.6285|||||||Fisher Exact|||||||0.6285
70878256|NCT02604212|141240422|SUPERIORITY|||||||0.7214|||||||Fisher Exact|||||||0.7214
70878257|NCT02604212|141240423|SUPERIORITY|||||||0.0325|||||||Fisher Exact|||||||0.0325
70878258|NCT02604212|141240423|SUPERIORITY|||||||0.1409|||||||Fisher Exact|||||||0.1409
70878259|NCT02604212|141240423|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
70878260|NCT02604212|141240424|SUPERIORITY|||||||0.0824|||||||Fisher Exact|||||||0.0824
70878261|NCT02604212|141240424|SUPERIORITY|||||||0.2217|||||||Fisher Exact|||||||0.2217
70878262|NCT02604212|141240424|SUPERIORITY|||||||0.1409|||||||Fisher Exact|||||||0.1409
70878263|NCT02604212|141240425|SUPERIORITY|||||||0.0625|||||||Fisher Exact|||||||0.0625
70958160|NCT00112047|141420119|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value is from the Wilcoxon Rank Sum Test|Wilcoxon Rank Sum test|No other adjustments were made||Null Hypothesis: Changes from Week 48 baseline to Week 144 in Limb Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 baseline to Week 144 in Limb Fat for the EFV+FTC+TDF and CBV+EFV groups are different||||0.001
70878264|NCT02604212|141240425|SUPERIORITY|||||||0.0684|||||||Fisher Exact|||||||0.0684
70878265|NCT02604212|141240425|SUPERIORITY|||||||0.2105|||||||Fisher Exact|||||||0.2105
70878266|NCT02604212|141240426|SUPERIORITY|||||||0.175|||||||Fisher Exact|||||||0.1750
70878267|NCT02604212|141240426|SUPERIORITY|||||||0.0229|||||||Fisher Exact|||||||0.0229
70878268|NCT02604212|141240426|SUPERIORITY|||||||0.0294|||||||Fisher Exact|||||||0.0294
70878269|NCT02604212|141240427|SUPERIORITY|||||||0.4615|||||||Fisher Exact|||||||0.4615
70878270|NCT02604212|141240427|SUPERIORITY|||||||0.0508|||||||Fisher Exact|||||||0.0508
70878271|NCT02604212|141240427|SUPERIORITY|||||||0.0769|||||||Fisher Exact|||||||0.0769
70878272|NCT02604212|141240428|SUPERIORITY|||||||0.0699|||||||Fisher Exact|||||||0.0699
70878273|NCT02604212|141240428|SUPERIORITY|||||||0.0179|||||||Fisher Exact|||||||0.0179
70878274|NCT02604212|141240428|SUPERIORITY|||||||0.043|||||||Fisher Exact|||||||0.0430
70878275|NCT02604212|141240429|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
70878276|NCT02604212|141240429|SUPERIORITY|||||||0.0849|||||||Fisher Exact|||||||0.0849
70878277|NCT02604212|141240429|SUPERIORITY|||||||0.0849|||||||Fisher Exact|||||||0.0849
70878278|NCT00598663|141240459|SUPERIORITY||Mean Difference (Final Values)|0.43|||<|0.0001|ONE_SIDED|97.5|||||ANCOVA|ANOVA with adjustment for period effect and subject as random effect. Period was included in the model regardless of statistical significance.||||||<0.0001
70878279|NCT01119131|141240466|SUPERIORITY_OR_OTHER|||||||0.699|TWO_SIDED||||||ANOVA|||||||0.699
70878280|NCT01119131|141240467|SUPERIORITY_OR_OTHER|||||||0.308|TWO_SIDED||||||ANOVA|||||||0.308
70878281|NCT01119131|141240468|SUPERIORITY_OR_OTHER|||||||0.419|TWO_SIDED||||||ANOVA|||||||0.419
70878282|NCT01119131|141240469|SUPERIORITY_OR_OTHER|||||||0.253|TWO_SIDED||||||ANOVA|||||||0.253
70878283|NCT01119131|141240470|SUPERIORITY_OR_OTHER|||||||0.793|TWO_SIDED||||||ANOVA|||||||0.793
70878284|NCT01119131|141240472|SUPERIORITY_OR_OTHER|||||||0.949|TWO_SIDED||||||ANOVA|||||||0.949
70878285|NCT01119131|141240473|SUPERIORITY_OR_OTHER|||||||0.957|TWO_SIDED||||||ANOVA|||||||0.957
70878286|NCT01341964|141240474|SUPERIORITY||Median Difference (Final Values)|0.05||||0.66|TWO_SIDED||||||t-test, 2 sided|not normally distributed, values were log-transformed.||||||0.66
70878287|NCT01516424|141240477|NON_INFERIORITY_OR_EQUIVALENCE|The power is 80%, non-inferiority margin is 7.0.|Mean Difference (Final Values)|3.69|||<|0.05|TWO_SIDED|95.0|-0.36|7.75||Satisfaction with the non-inferiority criteria was determined by the upper limit of confidence interval. If the upper limit of 95% confidence interval was less than 7.0, then non-inferiority was concluded.|ANCOVA|Study center and grouping as fixed effects.|This is ITT analysis data.|"ANCOVA was employed to compare the changes of PANSS scores at week 8 relative to the baseline in these 2 groups. Least Squares Means for the differences in changes between the 2 groups (μ blonanserin - μ risperidone) and the two-sided 95% Confidence Interval were calculated in accordance with the main model.~H0: Compared with risperidone, blonanserin reduced more than 7.0 in mean change in PANSS total score from baseline at week 8 of treatment (μ blonanserin-μ risperidone\> 7.0)."||7.75|-0.36|<0.05
70878288|NCT01516424|141240477|NON_INFERIORITY_OR_EQUIVALENCE|The power is 80%, non-inferiority margin is 7.0.|Mean Difference (Final Values)|2.94|||<|0.05|TWO_SIDED|95.0|-0.76|6.65||Satisfaction with the non-inferiority criteria was determined by the upper limit of confidence interval. If the upper limit of 95% confidence interval was less than 7.0, then non-inferiority was concluded.|ANCOVA|Study center and grouping as fixed effects.|This is PPS analysis data.|"ANCOVA was employed to compare the changes of PANSS total scores at end of treatment relative to the baseline in these 2 groups. LSMeans for the differences in changes between the 2 groups (μ blonanserin - μ risperidone) and the two-sided 95% Confidence Interval were calculated in accordance with the main model.~H0: Compared with risperidone, blonanserin reduced more than 7.0 in mean change in PANSS total score from baseline at week 8 of treatment (μ blonanserin-μ risperidone\> 7.0)."||6.65|-0.76|<0.05
70878289|NCT00597766|141240482|SUPERIORITY_OR_OTHER||GroupXtime interaction|-0.17||||0.16|TWO_SIDED|95.0||||Comparison 60mg vs. 20mg: F (1,92)=2.06, p=0.16|Linear mixed model|1st order antedependence covariance structure||"Hypothesis that 60mg group would have greater pain relief than the the 20mg group.~The study was powered to detect the difference in pain between the 40mg and placebo at 4-wks. To detect effect size 0.75 with alpha of 0.05, beta of 0.20, 31 the difference between the 60mg and placebo groups (effect size \> 1.0),18 participants per group are needed. \*NOTE\* the design was changed from placebo-control due to ethical concerns arising from ethical concerns of placebo injection."||||0.16
70878290|NCT00597766|141240482|SUPERIORITY_OR_OTHER||group x time interaction|-0.04||||0.77|TWO_SIDED|95.0||||Comparison 40mg vs. 20mg: F (1,90)=0.1, p=0.77|linear mixed model|first order antedependent covariance structure||"Hypothesis that 40mg group would have greater pain reduction than the 20mg group.~The study was powered to detect the difference in pain between the 40mg and placebo at 4-wks. To detect effect size 0.75 with alpha of 0.05, beta of 0.20, 31 the difference between the 60mg and placebo groups (effect size \> 1.0),18 participants per group are needed. \*NOTE\* the design was changed from placebo-control due to ethical concerns arising from ethical concerns of placebo injection."||||0.77
70958161|NCT00112047|141420120|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value is from the Wilcoxon Rank Sum Test|Wilcoxon Rank Sum test|No other adjustments were made||Null Hypothesis: Changes from Week 48 baseline to Week 144 in Trunk Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 baseline to Week 144 in Trunk Fat for the EFV+FTC+TDF and CBV+EFV groups are different||||0.011
70958162|NCT00112047|141420121|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from the Wilcoxon Rank Sum Test|Wilcoxon Rank Sum test|No other adjustments were made||Null Hypothesis: Changes from Week 48 baseline to Week 144 in Total Body Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 baseline to Week 144 in Total Body Fat for the EFV+FTC+TDF and CBV+EFV groups are different||||<0.001
70958163|NCT00112047|141420131|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||P-value is from the Wilcoxon Signed Rank test. No adjustments for multiple comparisons were made|Wilcoxon Signed Rank test|||Null Hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) limb fat value is equal to zero. Alternative hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) limb fat value is not equal to zero.||||0.16
70958164|NCT00112047|141420132|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||P-value is from the Wilcoxon Signed Rank test. No adjustments for multiple comparisons were made|Wilcoxon Signed Rank test|||Null Hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) trunk fat value is equal to zero. Alternative hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) trunk fat value is not equal to zero.||||0.049
70958165|NCT00112047|141420133|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||P-value is from the Wilcoxon Signed Rank test. No adjustments for multiple comparisons were made|Wilcoxon Signed Rank test|||Null Hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) total body fat value is equal to zero. Alternative hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) total body fat value is not equal to zero.||||0.055
70958166|NCT00112047|141420134|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||"The number and proportion of participants in each category (very satisfied, not very satisfied) were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test."|McNemar|||Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||<0.001
70958167|NCT00112047|141420135|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||"The number and proportion of participants in each category (very satisfied, not very satisfied) were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test."|McNemar|||Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||0.12
70958168|NCT00112047|141420136|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||"The number and proportion of participants in each category (very satisfied, not very satisfied) were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test."|McNemar|||Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||0.037
70878291|NCT00597766|141240483|SUPERIORITY_OR_OTHER||group x time interaction|-0.3||||0.2|TWO_SIDED|95.0||||Comparison 60mg vs. 20mg: F (1,36)=1.7, p=0.2|Linear mixed model|first order antedpendent covariance structure||This study was not powered for secondary outcomes. The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.||||0.2
70958169|NCT00112047|141420137|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||"The number and proportion of participants in each category (very satisfied, not very satisfied) were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test."|McNemar|||Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||0.013
70958170|NCT00112047|141420138|SUPERIORITY_OR_OTHER|||||||0.7||95.0||||"The number and proportion of participants in each category (bothers, does not bother) were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test."|McNemar|||Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||0.70
70958171|NCT00112047|141420139|SUPERIORITY_OR_OTHER|||||||0.95||95.0||||P-value is from the Wilcoxon Signed Rank Test.|Wilcoxon Signed Rank Test|||Null Hypothesis: There is no change in the PCS score from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a change in the PCS score from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||0.95
70958172|NCT00112047|141420140|SUPERIORITY_OR_OTHER|||||||0.23||95.0||||P-value is from the Wilcoxon Signed Rank Test|Wilcoxon Signed Rank Test|||Null Hypothesis: There is no change in the MCS score from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a change in the MCS score from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||0.23
70958173|NCT00910689|141420189|SUPERIORITY_OR_OTHER||||||<|0.01||||||Post tests consisted of 6 pair wise contrasts: The first 3 contrasts compared each of the 3 additive treatments (Trial Arms 2, 3, 4) to OAT + PL (Trial arm 1); 3 additional contrasts compared the 3 additive treatments to one another.|Mixed Models Analysis|A Bonferoni procedure was used to control the family-wise type I error for the 6 post test contrasts at .05. Adjusted p =.0083.||Omnibus Test: A mixed model with fixed effects for treatment,natural time(defined as natural log of months) and treatment-by-time interaction was used to obtain maximum likelihood estimates of missing values and to evaluate treatment effects(using the PROC MIXED procedure in SAS statistical software,version 9;www.sas.com). A significant treatment by time interaction(p \< .05, 2-tailed) was followed by post-tests (see below). Details of significant post tests are reported as separate analyses.||||< .01
70958174|NCT00910689|141420189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2|STANDARD_DEVIATION|0.57|<|0.001||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
70958175|NCT00910689|141420189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|0.68|>|0.25|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.||||> .25
70958176|NCT00910689|141420189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.59|>|0.98|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||> .98
70878292|NCT00597766|141240483|SUPERIORITY_OR_OTHER||group x time interaction|-0.02||||0.9|TWO_SIDED|95.0||||Comparison 40mg vs. 20mg: F (1,35)=0.0, p=0.9|linear mixed model|1st order antedependence covariance structure||This study was not powered for secondary outcomes.The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.||||0.9
70958177|NCT00910689|141420189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|STANDARD_DEVIATION|0.69|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
70958178|NCT00910689|141420189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_DEVIATION|0.61|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 120.||Post-test contrast. Mean difference in change.||||<.001
70958179|NCT00910689|141420189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|0.72|>|0.29|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||>.29
70958180|NCT00910689|141420190|SUPERIORITY_OR_OTHER||||||<|0.03|TWO_SIDED|95.0||||6 pair wise contrasts were conducted: The first 3 contrasts compared each of the 3 additive treatments to OAT + PL. The 3 additional contrasts compared the 3 additive treatments to one another.|Mixed Models Analysis|A Bonferoni procedure was used to control the family wise type I error for the 6 post test contrasts at .05. Adjusted p =.0083.||Omnibus test:A mixed model with fixed effects for treatment, time (defined as the natural log of months), and the treatment-by-time interaction was used to obtain maximum likelihood estimates of missing values and to evaluate treatment effects (PROC MIXED, SAS 9).When the treatment by time interaction was significant (p \< .05, 2-tailed)post-tests were conducted (see below).Details of significant post tests are reported as separate analyses.||||< .03
70958181|NCT00910689|141420190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|STANDARD_DEVIATION|1.03|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
70958182|NCT00910689|141420190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5|STANDARD_DEVIATION|1.12|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
70878293|NCT00597766|141240484|SUPERIORITY_OR_OTHER||Groupxtime interaction|1.3||||0.2|TWO_SIDED|95.0||||Comparison 60mg vs. 20mg: F (1,36)=1.6, p=0.2|linear mixed model|unstructured covariance structure||The study was not powered for secondary analyses. The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.||||0.2
70878294|NCT00597766|141240484|SUPERIORITY_OR_OTHER||Groupxtime interaction|1.1||||0.3|TWO_SIDED|95.0||||Comparison 40mg vs. 20mg: F (1,35)=1.0, p=0.3|linear mixed model|Unstructured covariance structure||Secondary outcomes were not powered for analysis. The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.||||0.3
70878295|NCT00597766|141240485|SUPERIORITY_OR_OTHER||group x time interaction|0.4||||0.8|TWO_SIDED|95.0||||Comparison 60mg vs. 20mg: F (1,36)=0.06, p=0.8|linear mixed model|first order antedepentent covariance structure||This study was not powered for secondary outcomes.The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.||||0.8
70878296|NCT00597766|141240485|SUPERIORITY_OR_OTHER||group x time interaction|1.7||||0.3|TWO_SIDED|95.0||||Comparison 40mg vs. 20mg: F (1,35)=1.1, p=0.3|linear mixed model|first order antedependent covariance structure||This study was not powered for secondary outcomes.The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.||||0.3
70878297|NCT00775645|141240498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.17|TWO_SIDED|95.0|-2.2|0.4|||Regression, Linear|Linear regression model adjusted for baseline score, taxane regiment, and age.||||0.4|-2.2|0.17
70878298|NCT00775645|141240499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.92|TWO_SIDED|95.0|-3.0|2.7|||Regression, Linear|Linear regression model adjusted for baseline score, taxane regiment, and age.||||2.7|-3|0.92
70878299|NCT00775645|141240500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.2|TWO_SIDED|95.0|-0.7|3.3|||Regression, Linear|Linear regression model adjusted for baseline score, taxane regiment, and age.||||3.3|-0.7|0.20
70878300|NCT00775645|141240501|SUPERIORITY|||||||0.46|||||||Regression, Linear|Adjusted for randomization stratification factors.||||||0.46
70878301|NCT00513474|141240514|SUPERIORITY|||||||0.036|||||||Gray's test for competing risks|||||||.036
70878302|NCT00605813|141240536|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was renal dysfunction. The null hypothesis is there is no difference between with and without renal dysfunction in the participants of responders."||||0.003
70878303|NCT00605813|141240537|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was past medical history of other illness. The null hypothesis is there is no difference between with and without past medical history of other illness in the participants of responders."||||<0.001
70878304|NCT00605813|141240538|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was non-pharmaceutical therapies. The null hypothesis is there is no difference between with or without non-pharmaceutical therapies in the participants of responders."||||0.040
70958183|NCT00910689|141420190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.1|STANDARD_DEVIATION|1.26|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
70958184|NCT00910689|141420190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_DEVIATION|1.2|>|0.02|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||> .02
70958185|NCT00910689|141420190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|1.35|>|0.79||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.||||>.79
70958186|NCT00910689|141420190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_DEVIATION|1.43|>|0.02||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|||Post-test contrast. Mean difference in change.||||>.02
70958187|NCT00910689|141420191|SUPERIORITY_OR_OTHER||||||<|0.005|TWO_SIDED|95.0||||Post tests consisted of 6 pair wise contrasts: The first 3 contrasts compared each of the 3 additive treatments (Trial Arms 2, 3, 4) to OAT + PL (Trial arm 1); three additional contrasts compared the 3 additive treatments to one another.|Mixed Models Analysis|A Bonferoni procedure controlled the familywise type I error for the 6 contrasts at .05. Adjusted p=.0083.||Omnibus test:A mixed model with fixed effects for treatment, time (defined as the natural log of months), and the treatment-by-time interaction and pretreatment Migraine Specific Quality of Life scores as covariate was used to obtain maximum likelihood estimates of missing values and to evaluate treatment effects (using the PROC MIXED procedure in SAS statistical software, version 9; www. sas.com).A significant treatment by time interaction (p \< .05, 2-tailed) was followed by post-tests||||<.005
70958188|NCT00910689|141420191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5|STANDARD_DEVIATION|2.18|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.||||< .001
70958189|NCT00910689|141420191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.0|STANDARD_DEVIATION|2.41|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
70958190|NCT00910689|141420191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4|STANDARD_DEVIATION|1.67|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||< .001
70958191|NCT00910689|141420191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.9|STANDARD_DEVIATION|2.03|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 120.||Post-test contrast. Mean difference in change.||||<.001
70958192|NCT00910689|141420191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.5|STANDARD_DEVIATION|1.83|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
70958193|NCT00910689|141420191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|2.38|>|0.87||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||>.87
70958194|NCT00910689|141420192|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_DEVIATION|0.77|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||<.001
70958195|NCT00910689|141420192|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.79|>|0.83|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||> .83
70958196|NCT00910689|141420192|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|0.67|>|0.05|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.||||> .05
70958197|NCT00910689|141420192|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|STANDARD_DEVIATION|0.86|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Significant post-test contrast. Mean difference in change.||||< .001
70958198|NCT00910689|141420192|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_DEVIATION|0.95|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 120.||Post-test contrast. Mean difference in change.||||<.001
70958199|NCT00910689|141420192|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|0.89|>|0.2|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||> .20
70958200|NCT00910689|141420193|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2|STANDARD_DEVIATION|1.7|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||<.001
70958201|NCT00910689|141420193|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.6|STANDARD_DEVIATION|1.96|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 120.||Post-test contrast. Mean difference in change.||||<.001
70958202|NCT00910689|141420193|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|STANDARD_DEVIATION|1.69|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
70958203|NCT00910689|141420193|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_DEVIATION|1.69|>|0.04||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||>.04
70958204|NCT00910689|141420193|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.34|>|0.33||95.0||||Bonerfoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.||||>0.33
70958205|NCT00910689|141420193|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.68|>|0.21||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||>0.21
70958206|NCT00910689|141420194|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.4|STANDARD_DEVIATION|3.0|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
70958207|NCT00910689|141420194|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.7|STANDARD_DEVIATION|3.29|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
70958208|NCT00910689|141420194|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.6|STANDARD_DEVIATION|2.99|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
70958209|NCT00910689|141420194|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_DEVIATION|2.85|>|0.56||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||>0.56
70958210|NCT00910689|141420194|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|STANDARD_DEVIATION|2.45|>|0.08||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.||||>0.08
70958211|NCT00910689|141420194|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|STANDARD_DEVIATION|2.83|>|0.03||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||>0.03
70958212|NCT02349425|141420223|SUPERIORITY||Estimated percent change|-41.222||||0.0055|TWO_SIDED|95.0|-59.294|-15.127|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-15.127|-59.294|0.0055
70958213|NCT02349425|141420223|SUPERIORITY||Estimated percent change|-51.973||||0.0008|TWO_SIDED|95.0|-68.23|-27.397|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-27.397|-68.230|0.0008
70878305|NCT00605813|141240539|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was present or past history of intentional suicidal ideation. The null hypothesis is there is no difference between present or past history of intentional suicidal ideation (including suicide attempt) in the participants of responders."||||0.004
70958214|NCT02349425|141420223|SUPERIORITY||Estimated percent change|-46.853||||0.0075|TWO_SIDED|95.0|-66.291|-16.206|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-16.206|-66.291|0.0075
70958215|NCT02349425|141420223|SUPERIORITY||Estimated percent change|-57.067||||0.0009|TWO_SIDED|95.0|-73.375|-30.771|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-30.771|-73.375|0.0009
70958216|NCT02349425|141420224|SUPERIORITY||Estimated percent change|-14.691||||0.2542|TWO_SIDED|95.0|-35.307|12.493|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||12.493|-35.307|0.2542
70958217|NCT02349425|141420224|SUPERIORITY||Estimated percent change|-25.165||||0.0267|TWO_SIDED|95.0|-42.014|-3.421|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-3.4210|-42.014|0.0267
70958218|NCT02349425|141420224|SUPERIORITY||Estimated percent change|-37.146||||0.0198|TWO_SIDED|95.0|-57.345|-7.3821|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-7.3821|-57.345|0.0198
70958219|NCT02349425|141420224|SUPERIORITY||Estimated percent change|-55.92||||0.0006|TWO_SIDED|95.0|-71.923|-30.797|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-30.797|-71.923|0.0006
70958220|NCT02349425|141420229|SUPERIORITY||Mean Difference (Final Values)|-19.0||||0.003|TWO_SIDED|95.0|-31.2|-6.8|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-6.8|-31.2|0.003
70958221|NCT02349425|141420229|SUPERIORITY||Mean Difference (Final Values)|-24.4|||<|0.001|TWO_SIDED|95.0|-36.7|-12.1|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-12.1|-36.7|<0.001
70958222|NCT02349425|141420229|SUPERIORITY||Mean Difference (Final Values)|-29.3||||0.005|TWO_SIDED|95.0|-49.0|-9.5|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model.||||-9.5|-49.0|0.005
70958223|NCT02349425|141420229|SUPERIORITY||Mean Difference (Final Values)|-29.6|||<|0.001|TWO_SIDED|95.0|-44.6|-14.7|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-14.7|-44.6|<0.001
70958224|NCT02349425|141420230|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.332|TWO_SIDED|95.0|-21.0|7.2|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||7.2|-21.0|0.332
70958225|NCT02349425|141420230|SUPERIORITY||Mean Difference (Final Values)|-13.5||||0.008|TWO_SIDED|95.0|-23.3|-3.6|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-3.6|-23.3|0.008
70878306|NCT02132767|141240549|SUPERIORITY_OR_OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
70878307|NCT02132767|141240550|SUPERIORITY_OR_OTHER|||||||0.003|||||||Log Rank|||||||0.003
70958226|NCT02349425|141420230|SUPERIORITY||Mean Difference (Final Values)|-30.2|||<|0.001|TWO_SIDED|95.0|-44.7|-15.7|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-15.7|-44.7|<0.001
70958227|NCT02349425|141420230|SUPERIORITY||Mean Difference (Final Values)|-26.7||||0.001|TWO_SIDED|95.0|-42.3|-11.0|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-11.0|-42.3|0.001
70958228|NCT02349425|141420231|SUPERIORITY||Mean Difference (Final Values)|-15.2|||<|0.001|TWO_SIDED|95.0|-23.5|-6.8|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-6.8|-23.5|<0.001
70958229|NCT02349425|141420231|SUPERIORITY||Mean Difference (Final Values)|-16.7|||<|0.001|TWO_SIDED|95.0|-26.1|-7.4|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-7.4|-26.1|<0.001
70958230|NCT02349425|141420231|SUPERIORITY||Mean Difference (Final Values)|-19.5||||0.002|TWO_SIDED|95.0|-31.1|-7.8|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-7.8|-31.1|0.002
70958231|NCT02349425|141420231|SUPERIORITY||Mean Difference (Final Values)|-20.5|||<|0.001|TWO_SIDED|95.0|-31.8|-9.3|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-9.3|-31.8|<0.001
70958232|NCT02349425|141420232|SUPERIORITY||Mean Difference (Final Values)|-4.1||||0.315|TWO_SIDED|95.0|-12.3|4.0|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||4.0|-12.3|0.315
70958233|NCT02349425|141420232|SUPERIORITY||Mean Difference (Final Values)|-7.2||||0.03|TWO_SIDED|95.0|-13.7|-0.7|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.7|-13.7|0.030
70958234|NCT02349425|141420232|SUPERIORITY||Mean Difference (Final Values)|-18.2|||<|0.001|TWO_SIDED|95.0|-27.4|-9.1|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-9.1|-27.4|<0.001
70958235|NCT02349425|141420232|SUPERIORITY||Mean Difference (Final Values)|-17.6|||<|0.001|TWO_SIDED|95.0|-26.3|-9.0|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-9.0|-26.3|<0.001
70958236|NCT02349425|141420233|SUPERIORITY||Mean Difference (Final Values)|-3.5||||0.169|TWO_SIDED|95.0|-8.6|1.6|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||1.6|-8.6|0.169
70958237|NCT02349425|141420233|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.341|TWO_SIDED|95.0|-7.5|2.6|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||2.6|-7.5|0.341
70958238|NCT02349425|141420233|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.311|TWO_SIDED|95.0|-5.8|1.9|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||1.9|-5.8|0.311
70958239|NCT02349425|141420233|SUPERIORITY||Mean Difference (Final Values)|-3.7||||0.128|TWO_SIDED|95.0|-8.6|1.1|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||1.1|-8.6|0.128
70958240|NCT02349425|141420234|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.613|TWO_SIDED|95.0|-3.5|5.9|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||5.9|-3.5|0.613
70958241|NCT02349425|141420234|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.743|TWO_SIDED|95.0|-4.3|3.1|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||3.1|-4.3|.743
70958242|NCT02349425|141420234|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.589|TWO_SIDED|95.0|-4.1|2.3|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||2.3|-4.1|0.589
70878308|NCT02132767|141240551|SUPERIORITY_OR_OTHER|||||||0.14|||||||Chi-squared|||||||0.14
70878309|NCT02132767|141240552|SUPERIORITY_OR_OTHER|||||||0.71|||||||Chi-squared|||||||0.71
70878310|NCT02132767|141240553|SUPERIORITY_OR_OTHER|||||||0.03|||||||Chi-squared|||||||0.03
70878311|NCT02132767|141240554|SUPERIORITY_OR_OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
70958243|NCT02349425|141420234|SUPERIORITY||Mean Difference (Final Values)|-5.1||||0.205|TWO_SIDED|95.0|-13.2|2.9|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||2.9|-13.2|0.205
70958244|NCT02349425|141420235|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.0811|TWO_SIDED|95.0|-1.4|0.1|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||0.1|-1.4|0.0811
70958245|NCT02349425|141420235|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.0097|TWO_SIDED|95.0|-2.2|-0.3|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.3|-2.2|0.0097
70958246|NCT02349425|141420235|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.0025|TWO_SIDED|95.0|-2.6|-0.6|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.6|-2.6|0.0025
70878312|NCT02132767|141240555|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.82
70878313|NCT02132767|141240556|SUPERIORITY_OR_OTHER|||||||0.73|||||||Regression, Poisson|||||||0.73
70878314|NCT00778700|141240569|SUPERIORITY||Least Squares (LS) Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.406||0.0041|TWO_SIDED|90.0|-1.85|-0.51|||ANCOVA|The ANCOVA model included treatment as the main factor and Baseline score as the covariate.||||-0.51|-1.85|0.0041
70958247|NCT02349425|141420235|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.005|TWO_SIDED|95.0|-2.8|-0.5|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.5|-2.8|0.0050
70958248|NCT02349425|141420236|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.0506|TWO_SIDED|95.0|-1.4|0.0|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||0.0|-1.4|0.0506
70958249|NCT02349425|141420236|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.0447|TWO_SIDED|95.0|-1.7|0.0|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.0|-1.7|0.0447
70958250|NCT02349425|141420236|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.0026|TWO_SIDED|95.0|-2.2|-0.5|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.5|-2.2|0.0026
70958251|NCT02349425|141420236|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.0405|TWO_SIDED|95.0|-2.2|0.0|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.0|-2.2|0.0405
70958252|NCT02349425|141420237|SUPERIORITY||Mean Difference (Final Values)|3.84|||<|0.001|TWO_SIDED|95.0|1.88|5.8|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||5.80|1.88|<0.001
70958253|NCT02349425|141420237|SUPERIORITY||Mean Difference (Final Values)|3.52|||<|0.001|TWO_SIDED|95.0|1.66|5.38|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||5.38|1.66|<0.001
70878315|NCT00778700|141240569|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.408||0.0007|TWO_SIDED|90.0|-2.08|-0.73|||ANCOVA|The ANCOVA model included treatment as the main factor and Baseline score as the covariate.||||-0.73|-2.08|0.0007
70958254|NCT02349425|141420238|SUPERIORITY||Mean Difference (Final Values)|-10.6||||0.096|TWO_SIDED|95.0|-23.2|1.9|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||1.9|-23.2|0.096
70958255|NCT02349425|141420238|SUPERIORITY||Mean Difference (Final Values)|-20.0||||0.005|TWO_SIDED|95.0|-33.6|-6.3|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-6.3|-33.6|0.005
70958256|NCT02349425|141420238|SUPERIORITY||Mean Difference (Final Values)|-26.1|||<|0.001|TWO_SIDED|95.0|-40.7|-11.6|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-11.6|-40.7|<0.001
70958257|NCT02349425|141420238|SUPERIORITY||Mean Difference (Final Values)|-33.8|||<|0.001|TWO_SIDED|95.0|-48.4|-19.1|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-19.1|-48.4|<0.001
70958258|NCT02349425|141420239|SUPERIORITY||Mean Difference (Final Values)|-6.4||||0.311|TWO_SIDED|95.0|-19.1|6.2|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||6.2|-19.1|0.311
70958259|NCT02349425|141420239|SUPERIORITY||Mean Difference (Final Values)|-7.4||||0.232|TWO_SIDED|95.0|-19.7|4.9|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||4.9|-19.7|0.232
70958260|NCT02349425|141420239|SUPERIORITY||Mean Difference (Final Values)|-15.6||||0.012|TWO_SIDED|95.0|-27.6|-3.6|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-3.6|-27.6|0.012
70958261|NCT02349425|141420239|SUPERIORITY||Mean Difference (Final Values)|-15.4||||0.043|TWO_SIDED|95.0|-30.4|-0.5|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.5|-30.4|0.043
70958262|NCT00118755|141420248|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.3883|TWO_SIDED|95.0|0.67|1.17|||Log Rank|||||1.17|0.67|0.3883
70958263|NCT00118755|141420249|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.2458|TWO_SIDED|95.0|0.64|1.12|||Log Rank|||||1.12|0.64|0.2458
70958264|NCT00118755|141420250|SUPERIORITY_OR_OTHER||Difference in Response Rate|9.8||||||95.0|0.9|18.7|||||95% Wald asymptotic CI using normal approximation (continuity corrected)|||18.7|0.9|
70958265|NCT00118755|141420251|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.6294||95.0|0.66|1.97|||Log Rank|||||1.97|0.66|0.6294
70958266|NCT00686725|141420255|SUPERIORITY_OR_OTHER|||||||0.183||95.0|||||Log Rank|||||||0.183
70958267|NCT00686725|141420256|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||Log Rank|||||||0.35
70958268|NCT00686725|141420259|SUPERIORITY_OR_OTHER|||||||0.648||95.0|||||Log Rank|||||||0.648
70958269|NCT00686725|141420260|SUPERIORITY_OR_OTHER|||||||0.915||95.0|||||Log Rank|||||||0.915
70958270|NCT01143038|141420270|SUPERIORITY_OR_OTHER_LEGACY||Mean|9.2|||||TWO_SIDED|95.0|8.3|10.1|||||Based on the t-distribution|||10.1|8.3|
70958271|NCT01143038|141420270|SUPERIORITY_OR_OTHER_LEGACY||Bootstrap mean|9.1|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|8.3|10.0|||||Estimates are based on bootstrap method with 1000 samples with replacement.|Bootstrap analysis||10.0|8.3|
70958272|NCT01749904|141420292|NON_INFERIORITY|The 2 treatments were compared for each time point by visit. LS mean of each treatment group, the difference in the LS mean, and the 2-sided 95% CI for the difference were obtained. Noninferiority could be claimed if the upper limit of the CIs \<1.5 mmHg at all time points of each visit and \<1.00 mmHg for at least 5 out of the 9 time points. If noninferiority was determined, superiority at each time point could be claimed if the upper limit of the 95% CI\<0 mmHg at all time points of each visit.|||||<|0.01||||||The ANCOVA results for the comparison of LS means of mean IOP between treatment groups demonstrated noninferiority of BOL-303259-X to timolol and also superiority of BOL-303259-X to timolol|ANCOVA|||||||<0.01
70958273|NCT01749904|141420293|OTHER|||||||0.005|||||||Chi-squared|||||||0.005
70958274|NCT01749904|141420294|OTHER|||||||0.001|||||||Chi-squared|||||||0.001
70958275|NCT01749904|141420295|OTHER||||||||||||||||||No statistical analysis was performed on these proportions.|||
70958276|NCT01878214|141420331|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Chi-squared|||||||0.76
70958277|NCT01878214|141420332|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||Regression, Logistic|||||||0.79
70958278|NCT01878214|141420333|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED||||||Regression, Logistic|||Smoking frequency||||0.63
70958279|NCT01878214|141420333|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Regression, Logistic|||Smoking quantity||||0.30
70958280|NCT01878214|141420334|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Regression, Logistic|||||||0.28
70958281|NCT01878214|141420335|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Regression, Logistic|||Motivation to quit||||0.09
70958282|NCT01878214|141420335|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Regression, Logistic|||Thinking about quitting||||0.04
70878316|NCT00778700|141240569|SUPERIORITY||LS Mean Difference|-1.21|STANDARD_ERROR_OF_MEAN|0.407||0.0035|TWO_SIDED|90.0|-1.88|-0.53|||ANCOVA|The ANCOVA model included treatment as the main factor and Baseline score as the covariate.||||-0.53|-1.88|0.0035
70878317|NCT01857232|141240691|SUPERIORITY|||||||0.004|||||||Regression, Logistic|||||||0.004
70878318|NCT01857232|141240691|SUPERIORITY|||||||0.0987|||||||Regression, Logistic|||||||0.0987
70878319|NCT01857232|141240691|SUPERIORITY|||||||0.1041|||||||Regression, Logistic|||||||0.1041
70878320|NCT01857232|141240692|SUPERIORITY|||||||0.0235|||||||Chi-squared, Corrected|1-sided||||||0.0235
70878321|NCT01857232|141240692|SUPERIORITY|||||||0.1651|||||||Chi-squared, Corrected|1-sided||||||0.1651
70878322|NCT01857232|141240692|SUPERIORITY|||||||0.1332|||||||Chi-squared, Corrected|1-sided||||||0.1332
70878323|NCT00416078|141240693|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED|||||F test of time X group effect F(1,3)=.26|Mixed Models Analysis|||intent to treat||||.65
70878324|NCT00416078|141240694|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED|||||t test of differential change over time in the two groups t(30)=.67|Mixed Models Analysis|||intent to treat analysis||||.51
70878325|NCT00416078|141240695|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED|||||t test of differential change over time in the two groups t(29)=.27|Mixed Models Analysis|||intent to treat analysis||||.79
70878326|NCT00416078|141240696|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED|||||t test for differential change over time in the two groups t(29)=.70|Mixed Models Analysis|||intent to treat analysis||||.49
70878327|NCT00416078|141240697|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED|||||t test for differential change over time in the two groups t(29)=.43|Mixed Models Analysis|||intent to treat analysis||||.67
70878328|NCT00416078|141240698|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||Fisher Exact|||||||.64
70878329|NCT00969150|141240736|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.49||||0.2492|TWO_SIDED|95.0|-4.02|1.05|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||1.05|-4.02|0.2492
70878330|NCT00969150|141240737|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.54||||0.5625|TWO_SIDED|95.0|-2.38|1.29|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||1.29|-2.38|0.5625
70878331|NCT00883116|141240753|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.0397|TWO_SIDED|95.0|1.0|1.7|||Log Rank|||||1.7|1.0|0.0397
70878332|NCT00883116|141240754|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.8011|TWO_SIDED|95.0|0.8|1.3|||Log Rank|||||1.3|0.8|0.8011
70878333|NCT04501666|141240778|SUPERIORITY||Strata adjusted percentage difference|40.1|||<|0.0001|TWO_SIDED|95.0|29.4|50.8||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||50.8|29.4|< 0.0001
70878334|NCT04501666|141240779|SUPERIORITY||Strata adjusted percentage difference|14.6||||0.0025|TWO_SIDED|95.0|6.7|22.6||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||22.6|6.7|0.0025
70878335|NCT04501666|141240781|SUPERIORITY||Strata adjusted percentage difference|31.7|||<|0.0001|TWO_SIDED|95.0|23.0|40.4||A 2-sided p-value was derived from CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||40.4|23.0|< 0.0001
70878336|NCT04501666|141240782|SUPERIORITY||Strata adjusted percentage difference|30.5|||<|0.0001|TWO_SIDED|95.0|22.3|38.7||A 2-sided p-value was derived from CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||38.7|22.3|< 0.0001
70878337|NCT04501666|141240783|SUPERIORITY||Strata adjusted percentage difference|38.0|||<|0.0001|TWO_SIDED|95.0|27.8|48.2||A 2-sided p-value was derived from CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||48.2|27.8|< 0.0001
70878338|NCT04501666|141240784|SUPERIORITY||Strata adjusted percentage difference|22.7|||<|0.0001|TWO_SIDED|95.0|14.7|30.7||A 2-sided p-value was derived from CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||30.7|14.7|< 0.0001
70878339|NCT04501666|141240785|SUPERIORITY||Strata adjusted percentage difference|18.7|||<|0.0001|TWO_SIDED|95.0|12.3|25.0||A 2-sided p-value was derived from CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||25.0|12.3|< 0.0001
70878340|NCT01722071|141240789|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED|||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||A two-sided paired t-test was performed to determine whether oxytocin administration was associated with reward-related BOLD signal changes (within the Nucleus Accumbens \[Bilateral\]). For the group of 18 participants, BOLD signal activity was compared between oxytocin and placebo scanning days.||||0.890
70878341|NCT01722071|141240789|SUPERIORITY_OR_OTHER|||||||0.422|TWO_SIDED|||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||A two-sided paired t-test was performed to determine whether oxytocin administration was associated with reward-related BOLD signal changes (within the Nucleus Accumbens \[Bilateral\]). For the group of 8 participants, BOLD signal activity was compared between oxytocin and placebo scanning days.||||0.422
70878342|NCT01722071|141240789|SUPERIORITY_OR_OTHER|||||||0.814|TWO_SIDED|||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||A two-sided paired t-test was performed to determine whether oxytocin administration was associated with reward-related BOLD signal changes (within the Nucleus Accumbens \[Bilateral\]). For the group of 10 participants, BOLD signal activity was compared between oxytocin and placebo scanning days.||||0.814
70878343|NCT00680043|141240822|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.238|||TWO_SIDED|97.5|-0.79|0.29|||ANOVA|||||0.29|-0.79|
70878344|NCT00680043|141240822|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.238|||TWO_SIDED|97.5|-0.56|0.52|||ANOVA|||||0.52|-0.56|
70878345|NCT00680043|141240824|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.84|1.01|||Cochran-Mantel-Haenszel|||||1.01|0.84|
70878346|NCT00680043|141240824|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.92|1.03|||Cochran-Mantel-Haenszel|||||1.03|0.92|
70878347|NCT00553150|141240825|SUPERIORITY_OR_OTHER_LEGACY||Maximum Tolerated Dose (mg)|70.0|||||TWO_SIDED|||||||||||||
70878348|NCT03061331|141240831|SUPERIORITY||Least Squares Mean Difference|0.1||||0.9277|TWO_SIDED|95.0|-2.5|2.7|||Mixed Model Repeated Measure (MMRM)|||||2.7|-2.5|0.9277
70878349|NCT01686633|141240842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108|||<|0.001|TWO_SIDED|95.0|0.045|0.171|||ANCOVA|||||0.171|0.045|<0.001
70878350|NCT01686633|141240842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|||||TWO_SIDED|95.0|-0.037|0.086||||||||0.086|-0.037|
70878351|NCT03761147|141240879|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70878352|NCT03204305|141240897|SUPERIORITY||t-test|-2.51||||0.02|TWO_SIDED|||||p \< 0.05 for all analyses. Bonferroni corrections were made to reduce family-wise error rate.|t-test, 2 sided|Composite VT was compared using independent t-tests.||VT in the 8 volumes of interest were analyzed using linear regression model group coded encoded as a dummy variable \[1=females cannabis users; 2= female healthy controls\], age as a covariate, and VT for VOIs (ventral striatum, amygdala, putamen, cingulate, globus pallidus, insula, frontal cortex, and hippocampus) as dependent variables, followed by post hoc Tukey's HSD between between groups.||||0.02
70878353|NCT03204305|141240897|SUPERIORITY||t-test|-2.36||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
70878354|NCT03204305|141240897|SUPERIORITY||t-test|-2.35||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
70878355|NCT03204305|141240897|SUPERIORITY||t-test|-2.23||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||0.04
70878356|NCT03204305|141240898|SUPERIORITY||t test|-2.52||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
70878357|NCT02335099|141240920|SUPERIORITY||Odds Ratio (OR)|3.77||||0.32|TWO_SIDED|95.0|0.27|217.52|||Fisher Exact|||||217.52|0.27|0.32
70878358|NCT02335099|141240921|SUPERIORITY||Cox Proportional Hazard|0.86||||0.82|TWO_SIDED|95.0|0.23|3.2|||Log Rank|||||3.20|0.23|0.82
70878359|NCT01765153|141240973|SUPERIORITY_OR_OTHER|||||||0.04366667|||||||t-test, 2 sided|||||||0.04366667
70878360|NCT00319644|141241024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.0||||0.26||95.0|||||Chi-squared|||The chi-square test(or Fisher exact test where needed) was used to compare proportions with dichotomous variables. The Student-t test was used for quantitative variables woth normal distribution, and Mann-Whitney-U test was used for data not normally distributed.||||0.26
70878361|NCT03232281|141241131|NON_INFERIORITY|If the lower limit of the 95% CI for the difference was \>-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was confirmed.|Rate difference (%)|-0.7|||||TWO_SIDED|95.0|-4.41|2.58|||||The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.|The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.||2.58|-4.41|
70878362|NCT03232281|141241132|NON_INFERIORITY|If the lower limit of the 95% CI for the difference was \>-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was observed without multiplicity adjustment.|Rate difference (%)|-1.3|||||TWO_SIDED|95.0|-5.26|1.93|||||The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.|Rate difference at Week 4. The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.||1.93|-5.26|
70958283|NCT00946101|141420336|NON_INFERIORITY_OR_EQUIVALENCE|For the calculation of the power to rule out a 10% increase of fever rate in vaccine recipients with 300 evaluable subjects (240 vaccine and 60 placebo recipients), it is assumed that the true fever rate in the monovalent vaccine group is 3.0% to 8.0%,and the true fever rate in placebo group is 0% to 3% lower than the fever rate in the vaccine group.|rate difference|0.0|||||TWO_SIDED|95.0|-6.4|3.1|||score|||The rate of subjects with fever between the two treatment groups was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo). The upper limit of the two-sided 95% confidence intervals was evaluated against the pre-specified equivalence criterion of 10% which corresponds to the following hypotheses: H0 (null): rate difference ≥ 10%, HA (alternative): rate difference \< 10%||3.1|-6.4|
70958284|NCT00946101|141420337|SUPERIORITY_OR_OTHER||rate difference|1.5|||||TWO_SIDED|95.0|-12.8|9.8|||score|||The number of subjects who experienced a post-dose seroresponse was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).||9.8|-12.8|
70958285|NCT00946101|141420338|SUPERIORITY_OR_OTHER||rate difference|4.9|||||TWO_SIDED|95.0|-9.6|13.8|||score|||The number of subjects who experienced a post-dose seroresponse was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).||13.8|-9.6|
70958286|NCT00946101|141420339|SUPERIORITY_OR_OTHER||rate difference|17.5|||||TWO_SIDED|95.0|5.5|27.1|||score|||The number of subjects who experienced a post-dose seroresponse was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).||27.1|5.5|
70958287|NCT00946101|141420340|SUPERIORITY_OR_OTHER||rate difference|5.1|||||TWO_SIDED|95.0|-8.4|17.6|||score|||Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compated following each dose. Exact two-sided 95% confidence intervals (Chan and Zhang, 1999) on the rate difference (Vaccine minus Placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.||17.6|-8.4|
70958288|NCT00946101|141420343|SUPERIORITY_OR_OTHER||rate difference|13.3|||||TWO_SIDED|95.0|-0.4|25.7|||score|||Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% confidence intervals (Chan and Zhang, 1999) on the rate difference (Vaccine minus Placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.||25.7|-0.4|
70958289|NCT00946101|141420346|SUPERIORITY_OR_OTHER||rate difference|-6.3|||||TWO_SIDED|95.0|-19.7|6.1|||score|||Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% confidence intervals (Chan and Zhang, 1999) on the rate difference (Vaccine minus Placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.||6.1|-19.7|
70958290|NCT00946101|141420349|SUPERIORITY_OR_OTHER||rate difference|-6.4|||||TWO_SIDED|95.0|-20.3|7.1|||score|||Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% confidence intervals (Chan and Zhang, 1999) on the rate difference (Vaccine minus Placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.||7.1|-20.3|
70958291|NCT00946101|141420358|SUPERIORITY_OR_OTHER||rate difference|7.0|||||TWO_SIDED|95.0|-6.1|14.7|||score|||The number of subjects who achieved a post Dose 1 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).||14.7|-6.1|
70958292|NCT00946101|141420359|SUPERIORITY_OR_OTHER||rate difference|7.2|||||TWO_SIDED|95.0|-5.8|15.1|||score|||The number of subjects who achieved a post Dose 1 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).||15.1|-5.8|
70958293|NCT00946101|141420360|SUPERIORITY_OR_OTHER||rate difference|16.7|||||TWO_SIDED|95.0|5.9|25.2|||score|||The number of subjects who achieved a post Dose 2 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).||25.2|5.9|
70958294|NCT02318992|141420369|OTHER|||||||0.157|||||||Chi-squared, Corrected|||||||0.157
70958295|NCT02318992|141420370|OTHER|||||||0.041|||||||Chi-squared, Corrected|||||||0.041
70878363|NCT03232281|141241132|NON_INFERIORITY|If the lower limit of the 95% CI for the difference was \>-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was observed without multiplicity adjustment.|Rate difference (%)|-2.7|||||TWO_SIDED|95.0|-6.8|-0.16|||||The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.|Rate difference at Week 8. The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.||-0.16|-6.80|
70878364|NCT03232281|141241133|NON_INFERIORITY|If the lower limit of the 95% CI for the difference was \>-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was observed without multiplicity adjustment.|Rate difference (%)|-1.3|||||TWO_SIDED|95.0|-5.26|1.93|||||The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.|Rate difference at Week 4. The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.||1.93|-5.26|
70958296|NCT00552240|141420375|NON_INFERIORITY_OR_EQUIVALENCE|A point estimate of -6.5% or higher for the diff. in the prop. of responders (NVP - ATV/r) was to be considered consistent with a successful ArTEN study. In the worst case for both studies, if the 2 studies were to be pooled, the non-inferiority margin of -12% would then be outside the 95% confidence interval (CI).|Difference in proportion of responders|-0.041||||0.7142||95.0|-0.183|0.101|||Cochran-Mantel-Haenszel|Controlling for screening viral load and CD4+ categories||With 75 evaluable patients per treatment group, this study had 80% power to observe a difference no lower than -6.5% assuming the true proportions of responders are both 65%.||0.101|-0.183|0.7142
70958297|NCT00552240|141420376|NON_INFERIORITY_OR_EQUIVALENCE|Same as for the primary analysis|Difference in proportion of responders|-0.027||||0.6479||95.0|-0.167|0.113|||Cochran-Mantel-Haenszel|Controlling for screening viral load and CD4+ categories||||0.113|-0.167|0.6479
70958298|NCT00552240|141420377|NON_INFERIORITY_OR_EQUIVALENCE|Same as for primary analysis|Difference in proportion of responders|0.084||||0.1477||95.0|-0.03|0.197|||Cochran-Mantel-Haenszel|Controlling for screening viral load and CD4+ categories||||0.197|-0.030|0.1477
70958299|NCT00552240|141420378|NON_INFERIORITY_OR_EQUIVALENCE|Same as for primary analysis|Difference in proportion of responders|-0.067||||0.3703||95.0|-0.215|0.08|||Cochran-Mantel-Haenszel|Controlling for screening viral load and CD4+ categories||||0.080|-0.215|0.3703
70958300|NCT00552240|141420379|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.666||||0.0314||95.0|0.46|0.964|||Regression, Cox|Controlling for screening viral load and CD4+ categories.||Hazard ratio Atazanavir plus ritonavir / Nevirapine. Values \< 1 indicate faster response in nevirapine.||0.964|0.460|0.0314
70958301|NCT00552240|141420380|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.628||||0.0172||95.0|0.428|0.921|||Regression, Cox|Controlling for screening viral load and CD4+ categories||"Responders only~Hazard ratio Atazanavir plus ritonavir / Nevirapine. Values \< 1 indicate faster response in nevirapine."||0.921|0.428|0.0172
70958302|NCT00552240|141420408|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.8||||0.7315||95.0|-8.4|11.9|||ANCOVA|Controlling for screening viral load and CD4+ categories||||11.9|-8.4|0.7315
70958303|NCT00552240|141420409|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-10.6||||0.3625||95.0|-33.4|12.3|||ANCOVA|Controlling for screening viral load and CD4+ categories||||12.3|-33.4|0.3625
70958304|NCT00552240|141420410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8||||0.0164||95.0|0.9|8.8|||ANCOVA|Controlling for screening viral load and CD4+ categories||||8.8|0.9|0.0164
70958305|NCT00552240|141420411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.9257||95.0|-8.4|9.3|||ANCOVA|Controlling for screening viral load and CD4+ categories||||9.3|-8.4|0.9257
70878365|NCT03232281|141241133|NON_INFERIORITY|If the lower limit of the 95% CI for the difference was \>-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was observed without multiplicity adjustment.|Rate difference (%)|-4.1|||||TWO_SIDED|95.0|-8.93|-0.52|||||The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.|Rate difference at Week 8. The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.||-0.52|-8.93|
70958306|NCT00552240|141420412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.0375||95.0|-0.64|-0.02|||ANCOVA|Controlling for screening viral load and CD4+ categories||||-0.02|-0.64|0.0375
70958307|NCT00552240|141420413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.4645||95.0|-1.02|0.47|||ANCOVA|Controlling for screening viral load and CD4+ categories||||0.47|-1.02|0.4645
70958308|NCT02783768|141420423|OTHER|Testing for difference in the outcome measure according to the exposure (which was not a treatment) in a randomized crossover setting.|Mean Difference (Net)|13.98||||0.012|TWO_SIDED|95.0|4.012|23.94|||Mixed Models Analysis||Measurements were included for participants with at least one valid MRI measurement.|"Within-person effects of e-cigarette exposure on pulmonary microvascular blood flow (PMBF) was assessed via mixed models accounting for order effects.~Null hypothesis: e-cigarette exposure is NOT associated with a change in PMBF.~Alternative hypothesis: e-cigarette exposure IS associated with a change in PMBF.~Power calculation: not applicable since this was a pilot/feasibility study."||23.94|4.012|0.012
70958309|NCT02319525|141420450|SUPERIORITY_OR_OTHER|||||||0.005|||||||t-test, 2 sided|||||||0.005
70958310|NCT02319525|141420451|SUPERIORITY_OR_OTHER|||||||0.08||||||We compared informed choice vs. no informed choice made between the decision aid and the pamphlet groups.|Chi-squared|||||||0.08
70958311|NCT02319525|141420452|SUPERIORITY_OR_OTHER|||||||0.252|||||||Chi-squared|||We compared concordance between preferred and actual roles vs. no concordance between roles between decision aid and pamphlet.||||0.252
70958312|NCT02319525|141420453|SUPERIORITY_OR_OTHER|||||||0.504|||||||t-test, 2 sided|||||||0.504
70958313|NCT02319525|141420454|SUPERIORITY_OR_OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.06
70958314|NCT02319525|141420455|SUPERIORITY_OR_OTHER|||||||0.006|||||||Chi-squared|||"statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the Impact of lupus nephritis"||||0.006
70958315|NCT02319525|141420455|SUPERIORITY_OR_OTHER|||||||0.006|||||||Chi-squared|||"statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the Risk factors"||||0.006
70958316|NCT02319525|141420455|SUPERIORITY_OR_OTHER|||||||0.003|||||||Chi-squared|||"statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the medication options"||||0.003
70958317|NCT02319525|141420455|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||"statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the evidence about medications"||||<0.001
70958318|NCT02319525|141420455|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||"statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the study about other patients"||||<0.001
70958319|NCT02319525|141420456|SUPERIORITY_OR_OTHER|||||||0.006|||||||Chi-squared|||The test of significance compared all the rows, i.e., all response options for the statement.||||0.006
70958320|NCT03386110|141420515|SUPERIORITY||Risk Ratio, log|1.19||||0.08|TWO_SIDED|95.0|-0.15|2.54|||Mixed Models Analysis|Model testing whether condition predicted illicit drug use at 3-months||Multi-level models tested whether treatment condition predicted outcome at 3-month follow-up, and controlled for the nesting of participants within couples.||2.54|-0.15|0.08
70958321|NCT03386110|141420515|SUPERIORITY||Risk Ratio, log|0.7||||0.25|TWO_SIDED|95.0|-0.49|1.89|||Mixed Models Analysis|Model testing whether condition predicted illicit drug use at 6-months||Multi-level models tested whether treatment condition predicted outcome at 6-months, and controlled for the nesting of participants within couples.||1.89|-0.49|0.25
70958322|NCT03386110|141420515|SUPERIORITY||Risk Ratio, log|1.79||||0.007|TWO_SIDED|95.0|0.49|3.09|||Mixed Models Analysis|Three-way interaction model testing whether baseline use (actor and partner) moderated the effect of condition on illicit drug use at 3-months||"Moderation analysis in 3-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment at 3-months was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples."||3.09|0.49|0.007
70958323|NCT03386110|141420515|SUPERIORITY||Risk Ratio, log|-0.36||||0.71|TWO_SIDED|95.0|-2.26|1.53|||Mixed Models Analysis|Three-way interaction model testing whether baseline use (actor and partner) moderated the effect of condition on illicit drug use at 6-months||"Moderation analysis in 6-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment at 6-months was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples."||1.53|-2.26|0.71
70878366|NCT03232281|141241133|NON_INFERIORITY|If the lower limit of the 95% CI for the difference was \>-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was observed without multiplicity adjustment.|Rate difference (%)|-2.7|||||TWO_SIDED|95.0|-7.44|1.17|||||The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.|Rate difference at Week 12. The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.||1.17|-7.44|
70878367|NCT00174915|141241145|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The overall 0.05 level of significance for the multiple comparisons of each febuxostat dose to placebo was controlled using Hochberg's method. The p-value was statistically significant.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL versus \[v.\] \>1.5 mg/dL).||||||<0.001
70878368|NCT00174915|141241145|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The overall 0.05 level of significance for the multiple comparisons of each febuxostat dose to placebo was controlled using Hochberg's method. The p-value was statistically significant.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
70958324|NCT03386110|141420516|SUPERIORITY||Risk Ratio, log|0.36||||0.36|TWO_SIDED|95.0|-0.65|1.37|||Mixed Models Analysis|Model testing whether condition predicted CAS events at 3-months||Multi-level models tested whether treatment condition predicted outcome at 3-months, and controlled for the nesting of participants within couples.||1.37|-0.65|0.36
70878369|NCT00174915|141241145|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The overall 0.05 level of significance for the multiple comparisons of each febuxostat dose to placebo was controlled using Hochberg's method. The p-value was statistically significant.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
70958325|NCT03386110|141420516|SUPERIORITY||Risk Ratio, log|-0.18||||0.63|TWO_SIDED|95.0|-1.15|0.78|||Mixed Models Analysis|Model testing whether condition predicted CAS events at 6-months||Multi-level models tested whether treatment condition predicted outcome at 6-months, and controlled for the nesting of participants within couples.||0.78|-1.15|0.63
70878370|NCT00174915|141241145|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of febuxostat 80 mg to allopurinol was declared if the value of the lower bound of the 97.5% confidence interval is \> -10%.|Difference in percentage|25.7||||||97.5|16.7|34.7||||||||34.7|16.7|
70878371|NCT00174915|141241145|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of febuxostat 120 mg to allopurinol was declared if the value of the lower bound of the 97.5% confidence interval is \> -10%.|Difference in percentage|42.7||||||97.5|34.0|51.3||||||||51.3|34.0|
70878372|NCT00174915|141241145|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparisons of each febuxostat dose to allopurinol were adjusted to control the overall 0.05 level of significance for superiority by using Hochberg's method. The p-value was statistically significant.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
70878373|NCT00174915|141241145|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparisons of each febuxostat dose to allopurinol were adjusted to control the overall 0.05 level of significance for superiority by using Hochberg's method. The p-value was statistically significant.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
70878374|NCT00174915|141241145|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
70878375|NCT00174915|141241145|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
70878376|NCT00174915|141241145|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
70878377|NCT00174915|141241145|SUPERIORITY_OR_OTHER|||||||0.479||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.479
70878378|NCT00174915|141241145|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
70878379|NCT00174915|141241146|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
70878380|NCT00174915|141241146|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
70878381|NCT00174915|141241146|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
70878382|NCT00174915|141241146|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
70878383|NCT00174915|141241146|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
70878384|NCT00174915|141241146|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
70878385|NCT00174915|141241146|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.011
70878386|NCT00174915|141241146|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
70878387|NCT00174915|141241146|SUPERIORITY_OR_OTHER|||||||0.091||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.091
70878388|NCT00174915|141241146|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
70878389|NCT00174915|141241147|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
70878390|NCT00174915|141241147|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
70878391|NCT00174915|141241147|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
70878392|NCT00174915|141241147|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
70878393|NCT00174915|141241147|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
70878394|NCT00174915|141241147|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
70878395|NCT00174915|141241147|SUPERIORITY_OR_OTHER|||||||0.074||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.074
70878396|NCT00174915|141241147|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
70878397|NCT00174915|141241147|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.001
70878398|NCT00174915|141241147|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
70878399|NCT00174915|141241148|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
70878400|NCT00174915|141241148|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
70878401|NCT00174915|141241148|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
70878402|NCT00174915|141241148|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
70878403|NCT00174915|141241148|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
70878404|NCT00174915|141241148|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
70878405|NCT00174915|141241148|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
70878406|NCT00174915|141241148|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
70878407|NCT00174915|141241148|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
70878408|NCT00174915|141241148|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
70878409|NCT00174915|141241149|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
70878410|NCT00174915|141241149|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
70878411|NCT00174915|141241149|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
70878412|NCT00174915|141241149|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
70878413|NCT00174915|141241149|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
70878414|NCT00174915|141241149|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
70878415|NCT00174915|141241149|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
70878416|NCT00174915|141241149|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
70958326|NCT03386110|141420516|SUPERIORITY||Risk Ratio, log|-0.54||||0.42|TWO_SIDED|95.0|-1.85|0.77|||Mixed Models Analysis|Three-way interaction model testing whether baseline rates of CAS (actor and partner) moderated the effect of condition on CAS events at 3-months||"Moderation analysis in 3-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment at 3-months was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples."||0.77|-1.85|0.42
70878417|NCT00174915|141241149|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
70958327|NCT03386110|141420516|SUPERIORITY||Risk Ratio, log|-1.7||||0.02|TWO_SIDED|95.0|-3.14|-0.27|||Mixed Models Analysis|Three-way interaction model testing whether baseline rates of CAS (actor and partner) moderated the effect of condition on CAS events at 6-months||"Moderation analysis in 6-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment at 6-months was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples."||-0.27|-3.14|0.02
70958328|NCT03386110|141420517|SUPERIORITY||Risk Ratio, log|0.48||||0.15|TWO_SIDED|95.0|-0.18|1.44|||Mixed Models Analysis|Model testing whether condition predicted marijuana use at 3-months||Multi-level models tested whether treatment condition predicted outcome at 3-months, and controlled for the nesting of participants within couples.||1.44|-0.18|0.15
70878418|NCT00174915|141241149|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
70878419|NCT00174915|141241150|SUPERIORITY_OR_OTHER|||||||0.789||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.789
70878420|NCT00174915|141241150|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.320
70878421|NCT00174915|141241150|SUPERIORITY_OR_OTHER|||||||0.381||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.381
70878422|NCT00174915|141241150|SUPERIORITY_OR_OTHER|||||||0.809||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.809
70878423|NCT00174915|141241150|SUPERIORITY_OR_OTHER|||||||0.154||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.154
70878424|NCT00174915|141241150|SUPERIORITY_OR_OTHER|||||||0.247||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.247
70878425|NCT00174915|141241150|SUPERIORITY_OR_OTHER|||||||0.415||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.415
70878426|NCT00174915|141241150|SUPERIORITY_OR_OTHER|||||||0.649||95.0||||Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.649
70878427|NCT00174915|141241150|SUPERIORITY_OR_OTHER|||||||0.807||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.807
70878428|NCT00174915|141241150|SUPERIORITY_OR_OTHER|||||||0.844||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.844
70878429|NCT00174915|141241151|SUPERIORITY_OR_OTHER|||||||0.699||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.699
70878430|NCT00174915|141241151|SUPERIORITY_OR_OTHER|||||||0.822||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.822
70878431|NCT00174915|141241151|SUPERIORITY_OR_OTHER|||||||0.579||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.579
70878432|NCT00174915|141241151|SUPERIORITY_OR_OTHER|||||||0.679||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.679
70878433|NCT00174915|141241151|SUPERIORITY_OR_OTHER|||||||0.278||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.278
70878434|NCT00174915|141241151|SUPERIORITY_OR_OTHER|||||||0.104||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.104
70878435|NCT00174915|141241151|SUPERIORITY_OR_OTHER|||||||0.56||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.560
70878436|NCT00174915|141241151|SUPERIORITY_OR_OTHER|||||||0.309||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.309
70878437|NCT00174915|141241151|SUPERIORITY_OR_OTHER|||||||0.759||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.759
70878438|NCT00174915|141241151|SUPERIORITY_OR_OTHER|||||||0.385||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.385
70878439|NCT00174915|141241152|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.949
70878440|NCT00174915|141241152|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.050
70878441|NCT00174915|141241152|SUPERIORITY_OR_OTHER|||||||0.577||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.577
70878442|NCT00174915|141241152|SUPERIORITY_OR_OTHER|||||||0.598||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.598
70878443|NCT00174915|141241152|SUPERIORITY_OR_OTHER|||||||0.062||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.062
70878444|NCT00174915|141241152|SUPERIORITY_OR_OTHER|||||||0.969||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.969
70878445|NCT00174915|141241152|SUPERIORITY_OR_OTHER|||||||0.056||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.056
70878446|NCT00174915|141241152|SUPERIORITY_OR_OTHER|||||||0.659||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.659
70878447|NCT00174915|141241152|SUPERIORITY_OR_OTHER|||||||0.197||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.197
70878448|NCT00174915|141241152|SUPERIORITY_OR_OTHER|||||||0.521||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.521
70878449|NCT00174915|141241153|SUPERIORITY_OR_OTHER|||||||0.683||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.683
70878450|NCT00174915|141241153|SUPERIORITY_OR_OTHER|||||||0.078||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.078
70878451|NCT00174915|141241153|SUPERIORITY_OR_OTHER|||||||0.442||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.442
70878452|NCT00174915|141241153|SUPERIORITY_OR_OTHER|||||||0.99||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.990
70878453|NCT00174915|141241153|SUPERIORITY_OR_OTHER|||||||0.077||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.077
70878454|NCT00174915|141241153|SUPERIORITY_OR_OTHER|||||||0.662||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.662
70878455|NCT00174915|141241153|SUPERIORITY_OR_OTHER|||||||0.139||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.139
70878456|NCT00174915|141241153|SUPERIORITY_OR_OTHER|||||||0.705||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.705
70878457|NCT00174915|141241153|SUPERIORITY_OR_OTHER|||||||0.337||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.337
70878458|NCT00174915|141241153|SUPERIORITY_OR_OTHER|||||||0.643||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.643
70878459|NCT00174915|141241154|SUPERIORITY_OR_OTHER|||||||0.645||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.645
70878460|NCT00174915|141241154|SUPERIORITY_OR_OTHER|||||||0.756||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.756
70878461|NCT00174915|141241154|SUPERIORITY_OR_OTHER|||||||0.428||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.428
70958329|NCT03386110|141420517|SUPERIORITY||Risk Ratio, log|0.24||||0.5|TWO_SIDED|95.0|-0.44|0.92|||Mixed Models Analysis|Model testing whether condition predicted marijuana use at 6-months||Multi-level models tested whether treatment condition predicted outcome at 6-months, and controlled for the nesting of participants within couples.||0.92|-0.44|0.50
70878462|NCT00174915|141241154|SUPERIORITY_OR_OTHER|||||||0.076||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons..|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL)||||||0.076
70958330|NCT03386110|141420517|SUPERIORITY||Risk Ratio, log|-0.02||||0.91|TWO_SIDED|95.0|-0.34|0.31|||Mixed Models Analysis|Three-way interaction model testing whether baseline use moderated the effect of condition on marijuana use at 3-months||"Moderation analysis in 3-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples."||0.31|-0.34|0.910
70878463|NCT00174915|141241154|SUPERIORITY_OR_OTHER|||||||0.106||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.106
70878464|NCT00174915|141241154|SUPERIORITY_OR_OTHER|||||||0.069||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.069
70878465|NCT00174915|141241154|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.837
70878466|NCT00174915|141241154|SUPERIORITY_OR_OTHER|||||||0.749||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.749
70878467|NCT00174915|141241154|SUPERIORITY_OR_OTHER|||||||0.581||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.581
70878468|NCT00174915|141241154|SUPERIORITY_OR_OTHER|||||||0.311||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.311
70878469|NCT00183092|141241155|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.43||||0.43|TWO_SIDED|95.0|0.58|3.53|||Regression, Cox|||||3.53|0.58|0.43
70878470|NCT00183092|141241156|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5||||0.54||95.0||||Threshold for statistical significance = 0.05. One subject in the placebo group was administered only 25 items on the MMSE due to visual impairment, and this subject's score was scaled based on percentage correct.|ANCOVA|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted changed (worsening) in the quinacrine group.||||.54
70878471|NCT00183092|141241157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.9||||0.36||95.0||||significance threshold p=0.05|Quade's rank analysis of covariance|||The difference between scores, adjusted for Month-0 performance.||||.36
70878472|NCT00183092|141241158|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.8||||0.01||95.0||||Significance threshold p\<0.05|Quade's rank analysis of covariance|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted changed (worsening) in the quinacrine group.||||.01
70878473|NCT00183092|141241159|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5||||0.03||95.0||||Threshold for significance p\<0.05|Quade's rank analysis of covariance|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted changed (worsening) in the quinacrine group.||||0.03
70878474|NCT00183092|141241160|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.92||95.0||||Significance threshold p\<0.05|ANCOVA|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted changed (worsening) in the quinacrine group.||||0.92
70878475|NCT00183092|141241161|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.71||95.0||||Significance threshold p\<0.05|ANCOVA|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted changed (worsening) in the quinacrine group.||||0.71
70878476|NCT00183092|141241162|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8||||0.7||95.0||||Significance threshold p\<0.05|ANCOVA|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted change (worsening) in the quinacrine group.||||0.70
70878477|NCT00469092|141241168|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is shown if the upper limit of the 95% CI is less than 0.4%. Furthermore, superiority of BIAsp 30 OD over insulin glargine OD was shown if the upper limit of the 95% CI for the difference is lower than 0%. Equivalence is shown if the upper limit of the 95% CI for the difference is lower than 0.4% and the lower limit of the 95% CI is greater than -0.4%.|Mean Difference (Net)|-0.16||||0.029||95.0|-0.3|-0.02||P-value is for the test for difference in means equals 0 against the alternative that the difference is different from 0.|Regression, Linear|||HbA1c was compared between the treatment groups by fitting a linear regression model (ANCOVA) with treatment and country as factors and the baseline values as a continuous covariate. Mean and SE are estimated from the model.||-0.02|-0.30|0.029
70878478|NCT00469092|141241169|SUPERIORITY_OR_OTHER|||||||0.0059||95.0||||P-value for parallelism is overall test for parallel time profiles between treatment groups i.e. time by treatment group interaction effect.|Mixed Models Analysis|||The profiles were compared between the treatment groups by fitting a repeated measures mixed model including treatment, time, the treatment-by-time interaction and country as fixed effects, and subject as random effect.||||0.0059
70878479|NCT00469092|141241170|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.914||||||95.0|0.57|1.47|||||The OR and 95% CI is for the HbA1c \<= 6.5% treatment target.|||1.47|0.57|
70878480|NCT00469092|141241170|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.014||||||95.0|0.67|1.54|||||The OR and 95% CI is for the HbA1c \< 7.0% treatment target.|||1.54|0.67|
70878481|NCT00469092|141241170|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.131||||||95.0|0.72|1.77|||||The OR and 95% CI is for the reduction more than 1.0% from baseline treatment target.|||1.77|0.72|
70878482|NCT00469092|141241170|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.905||||||95.0|0.59|1.38|||||The OR and 95% CI is for the HbA1c \< 7% no nocturnal (00:00-06:00) hypoglycemia treatment target|||1.38|0.59|
70878483|NCT00469092|141241170|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.181||||||95.0|0.74|1.87|||||The OR and 95% CI is for the HbA1c \< 7%, no daytime (06:01-23:59) hypoglycemia treatment target|||1.87|0.74|
70878484|NCT00469092|141241170|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.122||||||95.0|0.69|1.82|||||The OR and 95% CI is for the HbA1c \< 7%, no hypoglycemia treatment target.|||1.82|0.69|
70878485|NCT00469092|141241171|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||||95.0|-2.4|2.48|||||The mean difference and 95% CI is for the burden score. The scores were compared between the treatment groups by fitting a linear regression model with treatment and country as factors and the baseline values as a continuous covariate.|The Diab MedSat measure was scored as an overall score as well as three subscale scores. The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale. The overall score is the mean of all three subscales.||2.48|-2.40|
70878486|NCT00469092|141241171|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||||95.0|-3.56|3.11|||||The mean difference and 95% CI is for the efficacy score. The scores were compared between the treatment groups by fitting a linear regression model with treatment and country as factors and the baseline values as a continuous covariate.|The Diab MedSat measure was scored as an overall score as well as three subscale scores. The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale. The overall score is the mean of all three subscales.||3.11|-3.56|
70878487|NCT00469092|141241171|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||||95.0|-3.14|2.35|||||The mean difference and 95% CI is for the symptoms score. The scores were compared between the treatment groups by fitting a linear regression model with treatment and country as factors and the baseline values as a continuous covariate.|The Diab MedSat measure was scored as an overall score as well as three subscale scores. The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale. The overall score is the mean of all three subscales.||2.35|-3.14|
70878488|NCT00469092|141241171|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||||95.0|-2.36|2.14|||Regression, Linear||The mean difference and 95% CI is for the overall score. The scores were compared between the treatment groups by fitting a linear regression model with treatment and country as factors and the baseline values as a continuous covariate.|Diab MedSat measure was scored as an overall score as well as three subscale scores, and transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale. The overall score is the mean of all three subscales.||2.14|-2.36|
70878489|NCT02024867|141241174|NON_INFERIORITY_OR_EQUIVALENCE|The sample size of 120 per group was calculated according to an assumed treatment cure rate of 95% with 10 days of antibiotics, and a non-inferiority margin of 7% (allowing up to 88% cure rate with 3 days of antibiotics), to achieve a power of 0.80 (alpha=0.05). An additional 25 patients were recruited to account for an estimated 10% lost to follow-up.|Rate Difference|4.0||||0.25|TWO_SIDED|95.0|-1.5|9.5|||Chi-squared|||||9.5|-1.5|0.25
70878490|NCT02024867|141241175|NON_INFERIORITY_OR_EQUIVALENCE|described previously|Rate Difference|10.7||||0.02|TWO_SIDED|95.0|2.1|19.2|||Chi-squared|||||19.2|2.1|0.02
70878491|NCT02024867|141241176|NON_INFERIORITY_OR_EQUIVALENCE|described previously|Rate Difference|10.1||||0.03|TWO_SIDED|95.0|2.1|18.2|||Chi-squared|||||18.2|2.1|0.03
70878492|NCT02024867|141241177|NON_INFERIORITY_OR_EQUIVALENCE|described previously|Rate Difference|0.1|||>|0.05|TWO_SIDED|95.0|-6.9|7.0|||Chi-squared|||||7.0|-6.9|>0.05
70878493|NCT02024867|141241178|NON_INFERIORITY_OR_EQUIVALENCE|described previously|Rate Difference|10.3||||0.046|TWO_SIDED|95.0|0.8|19.9|||Chi-squared|||||19.9|0.8|0.046
70878494|NCT02024867|141241179|NON_INFERIORITY_OR_EQUIVALENCE|described previously|rate difference|0.0|||>|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||>0.05
70878495|NCT03992781|141241214|SUPERIORITY||Relative change|-53.1|||<|0.001|||||||t-test|||Relative change in CUDOS score between Visit 3 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
70878496|NCT03992781|141241215|SUPERIORITY||Relative change|-35.4|||<|0.001|||||||t-test|||Relative change in CUDOS score between Visit 2 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
70878497|NCT03992781|141241216|SUPERIORITY||Relative change|-33.2|||<|0.001|||||||t-test|||Relative change in CUXOS score between Visit 2 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
70878498|NCT03992781|141241216|SUPERIORITY||Relative change|-47.1|||<|0.001|||||||t-test|||Relative change in CUXOS score between Visit 3 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
70878499|NCT03992781|141241217|SUPERIORITY||Relative change|-27.6|||<|0.001|||||||t-test|||Relative change in JSEQ score between Visit 2 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
70878500|NCT03992781|141241217|SUPERIORITY||Relative change|-34.5|||<|0.001|||||||t-test|||Relative change in JSEQ score between Visit 3 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
70878501|NCT03992781|141241218|SUPERIORITY||Relative change|-43.4|||<|0.001|||||||t-test|||Relative change in VAS score between Visit 2 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
70878502|NCT03992781|141241218|SUPERIORITY||Relative change|-35.4|||<|0.001|||||||t-test|||Relative change in VAS score between Visit 3 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
70878503|NCT00385996|141241236|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Binomial distribution|Binomial distribution and test proportion =0.50||One arm phase 2 trial. This study is designed to asses response rate and defined as the percentage of subjects achieving at least 50% tumor volume. One-sided alpha is set at no more than 5% and the power no less than 90%,and the null hypothesis of RR of less than 10% and alternative hypothesis of RR of greater than 30%, a total of 30 patients will be enrolled (Fleming 1982).At least 7 responders out of 30 patients are needed to reject the null hypothesis of a 10% RR.||||<0.01
70878504|NCT00385996|141241238|OTHER||TTP [% without disease at 24 months]|63.6|||||TWO_SIDED|95.0|43.4|83.8|||||Using the Kaplan-Meier method.|One arm study||83.8|43.4|
70878505|NCT00385996|141241239|OTHER||% alive without disease at 25 months|72.7|||||TWO_SIDED|95.0|54.1|91.3|||||Using the Kaplan-Meier method.|One arm study||91.3|54.1|
70878506|NCT02733991|141241244|SUPERIORITY||Mean Difference (Final Values)|-2.88|||<|0.0001|TWO_SIDED|95.0|-3.51|-2.25|||Mixed Models Analysis||Model based Estimated mean; Treatment arm - Control arm|||-2.25|-3.51|<0.0001
70878507|NCT02733991|141241245|SUPERIORITY||Mean Difference (Final Values)|-42.62|||<|0.0001|TWO_SIDED|95.0|-52.01|-33.19|||Mixed Models Analysis||Model based Estimated mean; Treatment arm - Control arm|||-33.19|-52.01|<0.0001
70878508|NCT02733991|141241246|NON_INFERIORITY|Non-inferiority margin of 40 min/day|Mean Difference (Final Values)|-38.8|||||ONE_SIDED|97.5||-0.46|||||Model based Estimated mean; difference = control arm - treatment arm|||-0.46||
70878509|NCT02733991|141241246|SUPERIORITY||Mean Difference (Final Values)|38.8||||0.0474|TWO_SIDED|95.0|0.46|77.11|||Mixed Models Analysis||Model based Estimated mean; Difference = Treatment arm - Control arm|||77.11|0.46|0.0474
70878510|NCT00680745|141241263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.0867|<|0.0001|TWO_SIDED|95.0|-0.61|-0.27||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided)||-0.27|-0.61|<0.0001
70878511|NCT00680745|141241263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.0885|<|0.0001|TWO_SIDED|95.0|-0.67|-0.32||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided).||-0.32|-0.67|<0.0001
70878512|NCT00680745|141241263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.0873|<|0.0001|TWO_SIDED|95.0|-0.86|-0.51||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided).||-0.51|-0.86|<0.0001
70878513|NCT00680745|141241264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.3153||0.141|TWO_SIDED|95.0|-1.08|0.15||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||0.15|-1.08|0.1410
70878514|NCT00680745|141241264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.3217||0.0091|TWO_SIDED|95.0|-1.47|-0.21||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.21|-1.47|0.0091
70878515|NCT00680745|141241264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|0.3168|<|0.0001|TWO_SIDED|95.0|-2.17|-0.92||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.92|-2.17|<0.0001
70878516|NCT00680745|141241265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.5|STANDARD_ERROR_OF_MEAN|6.874|||TWO_SIDED|95.0|-45.0|-18.0||Not significant. Hierarchical closed testing procedure within treatment group stopped at previous endpoint.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-18.0|-45.0|
70958331|NCT03386110|141420517|SUPERIORITY||Risk Ratio, log|0.34||||0.11|TWO_SIDED|95.0|-0.07|0.75|||Mixed Models Analysis|||"Moderation analysis in 6-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples."||0.75|-0.07|0.11
70958332|NCT02697292|141420518|SUPERIORITY||Odds Ratio (OR)|10.5||||0.044|TWO_SIDED|95.0|1.1|98.9|||t-test, 1 sided|||||98.9|1.1|0.044
70958333|NCT02697292|141420519|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||0.100
70958334|NCT02318797|141420553|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Treatment by time interaction test||||<0.0001
70958335|NCT02318797|141420553|SUPERIORITY|||||||0.0019|||||||Mixed Models Analysis|||Test for gender by treatment by time interaction||||0.0019
70958336|NCT02318797|141420554|SUPERIORITY|||||||0.4103|||||||Mixed Models Analysis|||Treatment by time interaction test||||0.4103
70878517|NCT00680745|141241265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.0|STANDARD_ERROR_OF_MEAN|6.968||0.0002|TWO_SIDED|95.0|-39.7|-12.3||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-12.3|-39.7|0.0002
70878518|NCT00680745|141241265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.9|STANDARD_ERROR_OF_MEAN|6.77|<|0.0001|TWO_SIDED|95.0|-42.2|-15.6||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-15.6|-42.2|<0.0001
70958337|NCT02318797|141420554|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Test for change over time from baseline (only conducted if treatment by time interaction test non-significant)||||<0.0001
70958338|NCT02318797|141420554|SUPERIORITY|||||||0.4068|||||||Mixed Models Analysis|||Test for gender by treatment by time interaction||||0.4068
70958339|NCT02318797|141420554|SUPERIORITY|||||||0.2656|||||||Mixed Models Analysis|||Test for gender by treatment interaction (only calculated if gender by treatment by time non-significant)||||0.2656
70958340|NCT02318797|141420555|SUPERIORITY|||||||0.4582|||||||Mixed Models Analysis|||Treatment by time interaction test||||0.4582
70958341|NCT02318797|141420555|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Test for change over time from baseline (only conducted if treatment by time interaction test non-significant)||||<0.0001
70958342|NCT02318797|141420555|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||Test for gender by treatment by time interaction||||0.05
70958343|NCT02318797|141420555|SUPERIORITY|||||||0.1792|||||||Mixed Models Analysis|||Test for gender by treatment interaction (only calculated if gender by treatment by time non-significant)||||0.1792
70958344|NCT02318797|141420556|SUPERIORITY|||||||0.2179|||||||Mixed Models Analysis|||Treatment by time interaction test||||0.2179
70958345|NCT02318797|141420556|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Test for change over time from baseline (only conducted if treatment by time interaction test non-significant)||||<0.0001
70958346|NCT02318797|141420556|SUPERIORITY|||||||0.4797|||||||Mixed Models Analysis|||Test for gender by treatment by time interaction||||0.4797
70958347|NCT02318797|141420556|SUPERIORITY|||||||0.0014|||||||Mixed Models Analysis|||Test for gender by treatment interaction (only calculated if gender by treatment by time non-significant)||||0.0014
70958348|NCT02318797|141420557|SUPERIORITY|||||||0.0058|||||||Mixed Models Analysis|||Treatment by time interaction test||||0.0058
70958349|NCT02318797|141420558|SUPERIORITY|||||||0.0014|||||||Mixed Models Analysis|||Treatment by time interaction test||||0.0014
70958350|NCT02318797|141420559|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.0001
70958351|NCT02318797|141420560|SUPERIORITY|||||||0.5566|||||||Mixed Models Analysis|||Treatment by time interaction test||||0.5566
70958352|NCT02318797|141420560|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Test for change over time (only calculated if treatment by time interaction non-significant)||||<0.0001
70958353|NCT02318797|141420561|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.002
70958354|NCT02318797|141420562|SUPERIORITY|||||||0.0029|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.0029
70958355|NCT02318797|141420563|SUPERIORITY|||||||0.0021|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.0021
70958356|NCT02318797|141420564|SUPERIORITY|||||||0.1183|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.1183
70958357|NCT02318797|141420564|SUPERIORITY|||||||0.0569|||||||Mixed Models Analysis|||Test for change over time (only calculated if treatment by time interaction non-significant)||||0.0569
70958358|NCT02318797|141420565|SUPERIORITY|||||||0.0745|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.0745
70958359|NCT02318797|141420565|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Test for change over time (only calculated if treatment by time interaction non-significant)||||<0.0001
70958360|NCT02318797|141420566|SUPERIORITY|||||||0.1653|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.1653
70958361|NCT02318797|141420566|SUPERIORITY|||||||0.1772|||||||Mixed Models Analysis|||Test for change over time (only calculated if treatment by time interaction non-significant)||||0.1772
70958362|NCT02318797|141420567|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Test for treatment by time interaction||||<0.0001
70958363|NCT02318797|141420568|SUPERIORITY|||||||0.0202|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.0202
70958364|NCT02318797|141420569|SUPERIORITY|||||||0.4715|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.4715
70878519|NCT00680745|141241266|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.7|STANDARD_ERROR_OF_MEAN|4.265|||TWO_SIDED|95.0|5.4|22.1||Not significant. Hierarchical closed testing procedure within treatment group stopped at previous endpoint.|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||22.1|5.4|
70878520|NCT00680745|141241266|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.3|STANDARD_ERROR_OF_MEAN|4.392||0.0001|TWO_SIDED|95.0|8.7|25.9||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||25.9|8.7|0.0001
70878521|NCT00680745|141241266|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.7|STANDARD_ERROR_OF_MEAN|4.457|<|0.0001|TWO_SIDED|95.0|9.9|27.4||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||27.4|9.9|<0.0001
70878522|NCT00680745|141241267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.4159|||TWO_SIDED|95.0|-1.19|0.45||Not significant. Hierarchical closed testing procedure within treatment group stopped at previous endpoint.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||0.45|-1.19|
70878523|NCT00680745|141241267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|0.4234||0.0262|TWO_SIDED|95.0|-1.78|-0.11||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.11|-1.78|0.0262
70878524|NCT00680745|141241267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.67|STANDARD_ERROR_OF_MEAN|0.4211|<|0.0001|TWO_SIDED|98.0|-2.5|-0.84||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.84|-2.50|<0.0001
70878525|NCT00680745|141241268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9|STANDARD_ERROR_OF_MEAN|3.522|||TWO_SIDED|95.0|-21.8|-7.9||Not significant. Hierarchical closed testing procedure within treatment group stopped at previous endpoint.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-7.9|-21.8|
70878526|NCT00680745|141241268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.3|STANDARD_ERROR_OF_MEAN|3.594|<|0.0001|TWO_SIDED|95.0|-26.3|-12.2||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-12.2|-26.3|<0.0001
70878527|NCT00680745|141241268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.5|STANDARD_ERROR_OF_MEAN|3.545|<|0.0001|TWO_SIDED|95.0|-33.5|-19.5||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-19.5|-33.5|<0.0001
70878528|NCT02612428|141241269|SUPERIORITY||Hazard Ratio (HR)|0.913||||0.762|TWO_SIDED|95.0|0.509|1.64|||Log Rank|||The primary endpoint was assessed using a Kaplan-Meier survival analysis of the Intent-to-treat (ITT) population utilizing a log-rank test.||1.640|0.509|0.762
70878529|NCT02612428|141241270|SUPERIORITY|||||||0.6829|||||||Chi-squared|||||||0.6829
70878530|NCT02612428|141241271|SUPERIORITY|||||||0.048|||||||Chi-squared|||||||0.048
70878531|NCT00137423|141241272|SUPERIORITY_OR_OTHER||Objective Response Rate|28.3||||||95.0|16.8|42.3|||F distribution|||Objective response rate required a sample size of 100 to test null hypothesis that true response rate was \<=5% versus alternative hypothesis that true response rate was \>=15% with 90% power and alpha level of 0.05. If number of OR\> =11 null hypothesis that true response rate was \<=5% could be rejected with a target α error rate of 0.05.||42.3|16.8|
70878532|NCT00137423|141241272|SUPERIORITY_OR_OTHER||Objective Response Rate|11.5||||||95.0|4.4|23.4|||F distribution|||Objective response rate required a sample size of 100 to test null hypothesis that true response rate was \<=5% versus alternative hypothesis that true response rate was \>=15% with 90% power and alpha level of 0.05. If number of OR\> =11 null hypothesis that true response rate was \<=5% could be rejected with a target α error rate of 0.05.||23.4|4.4|
70878533|NCT00137423|141241276|SUPERIORITY_OR_OTHER||1-year survival rate|77.4||||||95.0|63.6|86.5|||Kaplan-Meier method||valid presentation only if at least 1 patient has overall survival \>=1 year. Based on normal approximation, 95% CI will be derived by log transformation of the cumulative hazard rate.|||86.5|63.6|
70958365|NCT02318797|141420569|SUPERIORITY|||||||0.9209|||||||Mixed Models Analysis|||Test for change over time (only calculated if treatment by time interaction non-significant)||||0.9209
70958366|NCT02673515|141420584|OTHER|||||||0.797|||||||t-test, 2 sided|||Comparison of changes from baseline to 4 weeks between groups was tested with student´s t-test or Mann Whitney-U-Test||||0.797
70958367|NCT04227704|141420641|SUPERIORITY|||||||0.09|||||||ANOVA|||||||0.09
70958368|NCT04227704|141420642|SUPERIORITY|||||||0.08|||||||ANOVA|||||||0.08
70958369|NCT04227704|141420649|SUPERIORITY|||||||0.44|||||||ANOVA|||||||0.44
70958370|NCT02390050|141420666|SUPERIORITY||Difference of LS Means|-0.55|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.34||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates||||-0.34|-0.76|< 0.0001
70958371|NCT02390050|141420666|SUPERIORITY||Difference of LS Means|-0.68|||<|0.0001|TWO_SIDED|95.0|-0.89|-0.47||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates||||-0.47|-0.89|< 0.0001
70958372|NCT02390050|141420666|SUPERIORITY||Difference of LS Means|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.01|-0.59||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates||||-0.59|-1.01|< 0.0001
70958373|NCT02390050|141420667|SUPERIORITY||Odds Ratio (OR)|2.1||||0.1308|TWO_SIDED|95.0|0.8|5.3|||Regression, Logistic|Treatment, country, baseline HbA1c and prior anti-diabetic treatment status as predictor variables and a dependable variable of 1 (\<7%) or 0 (\>7%).||Odds ratio of having at least 1 post-baseline HbA1c value \<7% in the 5 mg bexagliflozin group was compared to placebo group.||5.3|0.8|0.1308
70958374|NCT02390050|141420667|SUPERIORITY||Odds Ratio (OR)|2.0||||0.1294|TWO_SIDED|95.0|0.8|5.1|||Regression, Logistic|Treatment, country, baseline HbA1c and prior anti-diabetic treatment status as predictor variables and a dependable variable of 1 (\<7%) or 0 (\>7%).||Odds ratio of having at least 1 post-baseline HbA1c value \<7% in the 10 mg bexagliflozin group was compared to placebo group.||5.1|0.8|0.1294
70958375|NCT02390050|141420667|SUPERIORITY||Odds Ratio (OR)|4.2||||0.0015|TWO_SIDED|95.0|1.7|10.3|||Regression, Logistic|Treatment, country, baseline HbA1c and prior anti-diabetic treatment status as predictor variables and a dependable variable of 1 (\<7%) or 0 (\>7%).||Odds ratio of having at least 1 post-baseline HbA1c value \<7% in the 20 mg bexagliflozin group was compared to placebo group.||10.3|1.7|0.0015
70958376|NCT02390050|141420668|SUPERIORITY||Difference of LS Means|-0.74|||||TWO_SIDED|95.0|-1.13|-0.36||||||Week 2: Difference in LS mean change in body weight from baseline to week 2 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.36|-1.13|
70958377|NCT02390050|141420668|SUPERIORITY||Difference of LS Means|-0.76|||||TWO_SIDED|95.0|-1.15|-0.38||||||Week 2: Difference in LS mean change in body weight from baseline to week 2 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.38|-1.15|
70878534|NCT00137423|141241276|SUPERIORITY_OR_OTHER||1-year survival rate|66.0||||||95.0|51.6|77.1|||Kaplan-Meier method||valid presentation only if at least 1 patient has overall survival \>=1 year. Based on normal approximation, 95% CI will be derived by log transformation of the cumulative hazard rate.|||77.1|51.6|
70878535|NCT02141997|141241281|SUPERIORITY_OR_OTHER||||||=|0.863|||||||Fisher Exact|||P-value calculated using 1-sided Fisher's Exact test.||||=0.863
70878536|NCT02141997|141241281|SUPERIORITY_OR_OTHER||||||=|0.414|||||||Fisher Exact|||P-value calculated using 1-sided Fisher's Exact test.||||=0.414
70878537|NCT02141997|141241281|SUPERIORITY_OR_OTHER||||||=|0.196|||||||Fisher Exact|||P-value calculated using 1-sided Fisher's Exact test.||||=0.196
70878538|NCT04105998|141241292|SUPERIORITY|Exploratory analysis without power calculation||||||0.64|||||||t-test, 2 sided|||Exploratory analysis without power calculation||||0.64
70878539|NCT04105998|141241293|SUPERIORITY|Exploratory analysis without power calculation||||||0.19|||||||t-test, 2 sided|||Exploratory analysis without power calculation||||0.19
70878540|NCT04105998|141241294|SUPERIORITY|Exploratory analysis without power calculation||||||0.067|||||||t-test, 2 sided|||Exploratory analysis without power calculation||||0.067
70878541|NCT04105998|141241295|SUPERIORITY|Exploratory analysis without power calculation||||||0.25|||||||t-test, 2 sided|||Exploratory analysis without power calculation||||0.25
70878542|NCT04105998|141241296|SUPERIORITY|Exploratory analysis without power calculation||||||0.058|||||||t-test, 2 sided|||Exploratory analysis without power calculation||||0.058
70878543|NCT04105998|141241297|SUPERIORITY|Exploratory analysis without power calculation||||||0.111|||||||t-test, 2 sided|||Exploratory analysis without power calculation||||0.111
70878544|NCT01698801|141241344|SUPERIORITY_OR_OTHER||Overall dichotomized response rate|87.5|||<|0.0001|TWO_SIDED|95.0|74.269|100.0||One sample binomial test for the overall response rate was performed to provide p-value (significance level: 0.05) based on EE population. The hypotheses of interest are: H0: p = 0.3, H1: p ≠ 0.3, where p is overall response.|Binomial test for dichotomized response|||||100|74.269|<0.0001
70878545|NCT00312494|141241393|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1077||95.0||||The p-values reported are unadjusted for multiple comparisons. Dunnet's procedure for multiple dose comparisons to placebo was used for primary efficacy measure at Week 3.|Mixed Models Analysis|||N=135/arm (405 total) for 85% power for 2-sample t-test (2-sided alpha=0.05) based on true mean difference=3.5 and SD=10. Interim Analysis (IA) to validate sample-size assumptions and adjust sample-size if needed. Based on IA results total sample-size increased to N=223/arm (669 total) to maintain desired power. Null Hypothesis=No statistically significant difference between add-on ziprasidone (higher, lower dose) and add-on placebo groups with respect to the population mean for primary endpoint||||0.1077
70878546|NCT00312494|141241393|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4274||95.0||||The p-values reported are unadjusted for multiple comparisons. Dunnet's procedure for multiple dose comparisons to placebo was used for primary efficacy measure at Week 3.|Mixed Models Analysis|||Week 3 Mixed Model Repeated Measures (MMRM) with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score. Tests were 2-sided and performed at the 0.05 significance level.||||0.4274
70878547|NCT00312494|141241394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4025||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score.||||0.4025
70878548|NCT00312494|141241394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.283||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score.||||0.2830
70878549|NCT00312494|141241394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4125||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score.||||0.4125
70958378|NCT02390050|141420668|SUPERIORITY||Difference of LS Means|-0.99|||||TWO_SIDED|95.0|-1.38|-0.61||||||Week 2: Difference in LS mean change in body weight from baseline to week 2 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.61|-1.38|
70878550|NCT00312494|141241394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1527||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score.||||0.1527
70878551|NCT00312494|141241395|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0101||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.||||0.0101
70878552|NCT00312494|141241395|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0694||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.||||0.0694
70878553|NCT00312494|141241395|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0183||95.0||||The p-values reported are unadjusted for multiple comparisons|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.||||0.0183
70878554|NCT00312494|141241395|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0176||95.0||||The p-values reported are unadjusted for multiple comparisons|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.||||0.0176
70878555|NCT00312494|141241395|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2302||95.0||||The p-values reported are unadjusted for multiple comparisons|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.||||0.2302
70878556|NCT00312494|141241395|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0796||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.||||0.0796
70878557|NCT00312494|141241396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6191||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.||||0.6191
70958379|NCT02390050|141420668|SUPERIORITY||Difference of LS Means|-1.02|||||TWO_SIDED|95.0|-1.53|-0.52||||||Week 6: Difference in LS mean change in body weight from baseline to week 6 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.52|-1.53|
70878558|NCT00312494|141241396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5629||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.||||0.5629
70878559|NCT00312494|141241396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9049||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.||||0.9049
70958380|NCT02390050|141420668|SUPERIORITY||Difference of LS Means|-1.45|||||TWO_SIDED|95.0|-1.95|-0.94||||||Week 6: Difference in LS mean change in body weight from baseline to week 6 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.94|-1.95|
70958381|NCT02390050|141420668|SUPERIORITY||Difference of LS Means|-1.51|||||TWO_SIDED|95.0|-2.01|-1.01||||||Week 6: Difference in LS mean change in body weight from baseline to week 6 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-1.01|-2.01|
70958382|NCT02390050|141420668|SUPERIORITY||Difference of LS Means|-1.44|||<|0.0001|TWO_SIDED|95.0|-2.12|-0.76||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline weight as covariates||Week 12: Difference in LS mean change in body weight from baseline to week 12 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.76|-2.12|< 0.0001
70958383|NCT02390050|141420668|SUPERIORITY||Difference of LS Means|-1.59|||<|0.0001|TWO_SIDED|95.0|-2.26|-0.91||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline weight as covariates||Week 12: Difference in LS mean change in body weight from baseline to week 12 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.91|-2.26|< 0.0001
70958384|NCT02390050|141420668|SUPERIORITY||Difference of LS Means|-1.75|||<|0.0001|TWO_SIDED|95.0|-2.43|-1.08||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline weight as covariates||Week 12: Difference in LS mean change in body weight from baseline to week 12 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-1.08|-2.43|< 0.0001
70958385|NCT02390050|141420669|SUPERIORITY||Difference of LS Means|-0.48|||||TWO_SIDED|95.0|-0.9|-0.06||||||Week 2: Difference in LS mean change in FPG from baseline to week 2 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.06|-0.90|
70958386|NCT02390050|141420669|SUPERIORITY||Difference of LS Means|-0.9|||||TWO_SIDED|95.0|-1.31|-0.48||||||Week 2: Difference in LS mean change in FPG from baseline to week 2 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.48|-1.31|
70958387|NCT02390050|141420669|SUPERIORITY||Difference of LS Means|-1.04|||||TWO_SIDED|95.0|-1.45|-0.62||||||Week 2: Difference in LS mean change in FPG from baseline to week 2 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.62|-1.45|
70958388|NCT02390050|141420669|SUPERIORITY||Difference of LS Means|-0.93|||||TWO_SIDED|95.0|-1.39|-0.48||||||Week 6: Difference in LS mean change in FPG from baseline to week 6 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.48|-1.39|
70958389|NCT02390050|141420669|SUPERIORITY||Difference of LS Means|-1.17|||||TWO_SIDED|95.0|-1.62|-0.72||||||Week 6: Difference in LS mean change in FPG from baseline to week 6 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.72|-1.62|
70958390|NCT02390050|141420669|SUPERIORITY||Difference of LS Means|-1.1|||||TWO_SIDED|95.0|-1.55|-0.65||||||Week 6: Difference in LS mean change in FPG from baseline to week 6 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.65|-1.55|
70958391|NCT02390050|141420669|SUPERIORITY||Difference of LS Means|-0.85||||0.0002|TWO_SIDED|95.0|-1.29|-0.41||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline FPG as covariates||Week 12: Difference in LS mean change in FPG from baseline to week 12 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.41|-1.29|0.0002
70958392|NCT02390050|141420669|SUPERIORITY||Difference of LS Means|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.49|-0.6||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline FPG as covariates||Week 12: Difference in LS mean change in FPG from baseline to week 12 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.60|-1.49|< 0.0001
70958393|NCT02390050|141420669|SUPERIORITY||Difference of LS Means|-1.07|||<|0.0001|TWO_SIDED|95.0|-1.52|-0.63||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline FPG as covariates||Week 12: Difference in LS mean change in FPG from baseline to week 12 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.63|-1.52|< 0.0001
70958394|NCT02390050|141420670|SUPERIORITY||Difference of LS Means|-0.19|||||TWO_SIDED|95.0|-3.9|3.51||||||Week 2: Difference in LS mean change in SBP from baseline to week 2 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||3.51|-3.90|
70958395|NCT02390050|141420670|SUPERIORITY||Difference of LS Means|-2.41|||||TWO_SIDED|95.0|-6.09|1.28||||||Week 2: Difference in LS mean change in SBP from baseline to week 2 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||1.28|-6.09|
70958396|NCT02390050|141420670|SUPERIORITY||Difference of LS Means|-4.25|||||TWO_SIDED|95.0|-7.93|-0.58||||||Week 2: Difference in LS mean change in SBP from baseline to week 2 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.58|-7.93|
70958397|NCT02390050|141420670|SUPERIORITY||Difference of LS Means|-0.18|||||TWO_SIDED|95.0|-2.5|2.13||||||Week 2: Difference in LS mean change in DBP from baseline to week 2 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||2.13|-2.50|
70958398|NCT02390050|141420670|SUPERIORITY||Difference of LS Means|-1.74|||||TWO_SIDED|95.0|-4.03|0.56||||||Week 2: Difference in LS mean change in DBP from baseline to week 2 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||0.56|-4.03|
70958399|NCT02390050|141420670|SUPERIORITY||Difference of LS Means|-2.15|||||TWO_SIDED|95.0|-4.45|0.14||||||Week 2: Difference in LS mean change in DBP from baseline to week 2 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||0.14|-4.45|
70958400|NCT02390050|141420670|SUPERIORITY||Difference of LS Means|-0.84|||||TWO_SIDED|95.0|-4.57|2.9||||||Week 6: Difference in LS mean change in SBP from baseline to week 6 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||2.90|-4.57|
70878560|NCT00312494|141241396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7153||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.||||0.7153
70878561|NCT00312494|141241396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.242||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.||||0.2420
70878562|NCT00312494|141241396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6121||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.||||0.6121
70878563|NCT00312494|141241397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6138||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.||||0.6138
70878564|NCT00312494|141241397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6536||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.||||0.6536
70878565|NCT00312494|141241397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4758||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.||||0.4758
70878566|NCT00312494|141241397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7581||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.||||0.7581
70878567|NCT00312494|141241397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2221||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.||||0.2221
70878568|NCT00312494|141241397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5665||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.||||0.5665
70878569|NCT00312494|141241398|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1063||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 total score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS total score.||||0.1063
70878570|NCT00312494|141241398|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2499||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 total score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS total score.||||0.2499
70878571|NCT00312494|141241398|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0876||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 positive score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS positive score.||||0.0876
70878572|NCT00312494|141241398|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3623||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 positive score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS positive score.||||0.3623
70878573|NCT00312494|141241398|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4686||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 negative score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS negative score.||||0.4686
70878574|NCT00312494|141241398|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2202||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 negative score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS negative score.||||0.2202
70878575|NCT00312494|141241399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0728||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline GAF score.||||0.0728
70878576|NCT00312494|141241399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3174||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline GAF score.||||0.3174
70878577|NCT00312494|141241400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.446||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline LIFE-RIFT total score.||||0.4460
70878578|NCT00312494|141241400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3253||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline LIFE-RIFT total score.||||0.3253
70878579|NCT01304966|141241417|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||t-test, 1 sided|||||||0.013
70878580|NCT00003901|141241421|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.59||||0.007|TWO_SIDED|95.0|1.13|2.23|||Regression, Cox|||||2.23|1.13|0.007
70878581|NCT00003901|141241422|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.03||||0.886|TWO_SIDED|95.0|0.69|1.54|||Regression, Cox|||||1.54|0.69|0.886
70878582|NCT00003901|141241423|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.63||||0.009|TWO_SIDED|95.0|1.13|2.36|||Regression, Cox|||||2.36|1.13|0.009
70958401|NCT02390050|141420670|SUPERIORITY||Difference of LS Means|-3.39|||||TWO_SIDED|95.0|-7.12|0.34||||||Week 6: Difference in LS mean change in SBP from baseline to week 6 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||0.34|-7.12|
70958402|NCT02390050|141420670|SUPERIORITY||Difference of LS Means|-2.51|||||TWO_SIDED|95.0|-6.21|1.2||||||Week 6: Difference in LS mean change in SBP from baseline to week 6 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||1.20|-6.21|
70958403|NCT02390050|141420670|SUPERIORITY||Difference of LS Means|0.25|||||TWO_SIDED|95.0|-2.15|2.66||||||Week 6: Difference in LS mean change in DBP from baseline to week 6 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||2.66|-2.15|
70958404|NCT02390050|141420670|SUPERIORITY||Difference of LS Means|-1.02|||||TWO_SIDED|95.0|-3.42|1.38||||||Week 6: Difference in LS mean change in DBP from baseline to week 6 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||1.38|-3.42|
70958405|NCT02390050|141420670|SUPERIORITY||Difference of LS Means|-0.84|||||TWO_SIDED|95.0|-3.22|1.54||||||Week 6: Difference in LS mean change in DBP from baseline to week 6 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||1.54|-3.22|
70958406|NCT02390050|141420670|SUPERIORITY||Difference of LS Means|-2.16||||0.3001|TWO_SIDED|95.0|-6.26|1.94||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates||Week 12: Difference in LS mean change in SBP from baseline to week 12 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||1.94|-6.26|0.3001
70958407|NCT02390050|141420670|SUPERIORITY||Difference of LS Means|-4.41||||0.0343|TWO_SIDED|95.0|-8.49|-0.33||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates||Week 12: Difference in LS mean change in SBP from baseline to week 12 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.33|-8.49|0.0343
70878583|NCT00003901|141241424|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.78||||0.332|TWO_SIDED|95.0|0.48|1.28|||Regression, Cox|||||1.28|0.48|0.332
70958408|NCT02390050|141420670|SUPERIORITY||Difference of LS Means|-3.83||||0.0679|TWO_SIDED|95.0|-7.95|0.28|||ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates||Week 12: Difference in LS mean change in SBP from baseline to week 12 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||0.28|-7.95|0.0679
70958409|NCT02390050|141420670|SUPERIORITY||Difference of LS Means|-2.24||||0.0776|TWO_SIDED|95.0|-4.73|0.25||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates||Week 12: Difference in LS mean change in DBP from baseline to week 12 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||0.25|-4.73|0.0776
70958410|NCT02390050|141420670|SUPERIORITY||Difference of LS Means|-1.47||||0.2415|TWO_SIDED|95.0|-3.95|1.0||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates||Week 12: Difference in LS mean change in DBP from baseline to week 12 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||1.00|-3.95|0.2415
70878584|NCT00527943|141241439|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.92||||0.072|TWO_SIDED|95.0|0.85|1.01|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.01|0.85|0.072
70878585|NCT00527943|141241440|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.89||||0.018|TWO_SIDED|95.0|0.81|0.98|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.98|0.81|0.018
70878586|NCT00527943|141241441|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.36|||<|0.001|TWO_SIDED|95.0|1.18|1.57|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.57|1.18|<0.001
70878587|NCT00527943|141241442|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.41|||<|0.001|TWO_SIDED|95.0|1.29|1.54|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.54|1.29|<0.001
70878588|NCT00527943|141241443|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.91||||0.038|TWO_SIDED|95.0|0.84|1.0|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.00|0.84|0.038
70878589|NCT00527943|141241444|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9||||0.027|TWO_SIDED|95.0|0.81|0.99|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.99|0.81|0.027
70878590|NCT00527943|141241445|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.94||||0.174|TWO_SIDED|95.0|0.87|1.03|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.03|0.87|0.174
70878591|NCT00527943|141241446|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.93||||0.108|TWO_SIDED|95.0|0.86|1.02|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.02|0.86|0.108
70878592|NCT00527943|141241447|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.0||||0.963|TWO_SIDED|95.0|0.83|1.22|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.22|0.83|0.963
70878593|NCT00527943|141241448|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.021|TWO_SIDED|95.0|0.79|0.98|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.98|0.79|0.021
70878594|NCT00527943|141241449|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.14||||0.418|TWO_SIDED|95.0|0.83|1.58|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.58|0.83|0.418
70878595|NCT00527943|141241450|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.07||||0.493|TWO_SIDED|95.0|0.88|1.31|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.31|0.88|0.493
70878596|NCT00527943|141241451|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.05||||0.515|TWO_SIDED|95.0|0.9|1.23|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.23|0.90|0.515
70958411|NCT02390050|141420670|SUPERIORITY||Difference of LS Means|-2.04||||0.1086|TWO_SIDED|95.0|-4.54|0.46||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates||Week 12: Difference in LS mean change in DBP from baseline to week 12 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||0.46|-4.54|0.1086
70958412|NCT02390050|141420671|SUPERIORITY||Difference of LS Means|-0.09|||||TWO_SIDED|95.0|-0.2|0.03||||||Week 2: Difference in LS Mean change in HbA1c (%) from baseline to Week 2 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||0.03|-0.20|
70958413|NCT02390050|141420671|SUPERIORITY||Difference of LS Means|-0.13|||||TWO_SIDED|95.0|-0.24|-0.02||||||Week 2: Difference in LS Mean change in HbA1c (%) from baseline to Week 2 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.02|-0.24|
70878597|NCT00527943|141241452|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.93||||0.606|TWO_SIDED|95.0|0.7|1.23|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.23|0.70|0.606
70878598|NCT04949165|141241483|NON_INFERIORITY|The study employed a non-inferiority design with a non-inferiority margin of 1 g/dL for haemoglobin levels at 4 months, a 1-sided alpha level of 0.025, at least 85% power and under the assumption that the true difference in the means was 0.3 g/dL. The estimated sample size also allowed for up to 10% loss to follow- up or iron supplementation for those initially not requiring supplements, thus the sample size was 292.||||||0.025||||||Non-inferiority threshold of -1 g/dL for the lower bound of the 97.5% CI.|t-test, 1 sided|||||||0.025
70878599|NCT03033511|141241487|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.537|TWO_SIDED|95.0|0.84|1.36||stratified log-rank test|Log Rank|||||1.36|0.84|0.537
70878600|NCT03033511|141241488|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.237|TWO_SIDED|95.0|0.92|1.36||stratified log-rank test|Log Rank|||||1.36|0.92|0.237
70878601|NCT03033511|141241489|SUPERIORITY||Least Squares (LS) Mean of Difference|-0.36|STANDARD_ERROR_OF_MEAN|1.39|||TWO_SIDED|95.0|-3.08|2.35||||||Change at Week 6||2.35|-3.08|
70878602|NCT03033511|141241489|SUPERIORITY||LS Mean of Difference|-10.43|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|95.0|-14.58|-6.29||||||Change at Week 12||-6.29|-14.58|
70878603|NCT03033511|141241489|SUPERIORITY||LS Mean of Difference|-27.67|STANDARD_ERROR_OF_MEAN|10.57|||TWO_SIDED|95.0|-46.19|-9.16||||||Change at Week 18||-9.16|-46.19|
70878604|NCT03033511|141241489|SUPERIORITY||LS Mean of Difference|-18.44|STANDARD_ERROR_OF_MEAN|9.99|||TWO_SIDED|95.0|-38.28|1.39||||||Change at Week 24||1.39|-38.28|
70878605|NCT03033511|141241489|SUPERIORITY||LS Mean of Difference|-22.0|STANDARD_ERROR_OF_MEAN|11.27|||TWO_SIDED|95.0|-42.63|-1.37||||||Change at Week 30||-1.37|-42.63|
70878606|NCT03033511|141241489|SUPERIORITY||LS Mean of Difference|0.0|||||TWO_SIDED|||||||||Change at Week 36||||
70878607|NCT03033511|141241489|SUPERIORITY||LS Mean of Difference|3.33|||||TWO_SIDED|||||||||Change at Week 42||||
70878608|NCT03033511|141241489|SUPERIORITY||LS Mean of Difference|-56.67|||||TWO_SIDED|||||||||Change at Week 48||||
70878609|NCT03033511|141241489|SUPERIORITY||LS Mean of Difference|0.0|||||TWO_SIDED|||||||||Change at Week 60||||
70878610|NCT03033511|141241489|SUPERIORITY||LS Mean of Difference|0.0|||||TWO_SIDED|||||||||Change at Week 66||||
70878611|NCT03033511|141241489|SUPERIORITY||LS Mean of Difference|0.0|||||TWO_SIDED|||||||||Change at Week 78||||
70878612|NCT03033511|141241489|SUPERIORITY||LS Mean of Difference|-9.17|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|95.0|-12.16|-6.19||||||Change at Final Visit||-6.19|-12.16|
70958414|NCT02390050|141420671|SUPERIORITY||Difference of LS Means|-0.13|||||TWO_SIDED|95.0|-0.24|-0.02||||||Week 2: Difference in LS Mean change in HbA1c (%) from baseline to Week 2 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.02|-0.24|
70878613|NCT00531817|141241736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.85|||<|0.0001|TWO_SIDED|95.0|12.29|25.42||The p-value was not adjusted. The primary objective was a single comparison with an a priori threshold of 0.05 for statistical significance.|Fisher Exact|||Power calculation: Assuming placebo+DMARDs response rate of 15% and tocilizumab 8 mg/kg+DMARDs response rate of 28% based on previous trials, a sample size of 570 patients (2:1 ratio, tocilizumab+DMARDs n=380 and placebo+DMARDs n=190) will provide \> 90% power to detect a difference between 2 treatment arms with 5% Type I error with a 2-sided Fisher's exact test. Null Hypothesis: The percentage of patients responding in each treatment group (tocilizumab+DMARDs vs placebo+ DMARDs) is the same.||25.42|12.29|<0.0001
70878614|NCT00894322|141241757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.269||0.0013|TWO_SIDED|95.0|-1.5|-0.4||Treatment group and HbA1c stratum at screening were factors. Placebo was reference group.|ANOVA|||||-0.40|-1.50|0.0013
70878615|NCT00894322|141241758|SUPERIORITY_OR_OTHER|||||||0.0033|||||||Cochran-Mantel-Haenszel|Adjusted for HbA1c strata at screening.||||||0.0033
70878616|NCT00894322|141241759|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.835||0.2285|TWO_SIDED|95.0|-2.73|0.68|||ANOVA|treatment group and HbA1c stratum at screening were factors.||Least square mean (LS) mean, 95% confidence interval (CI) and p-value calculated for the changes in weight from baseline in participants in cohort 2 treated with exenatide with placebo as reference group.||0.68|-2.73|0.2285
70878617|NCT00894322|141241760|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.4|STANDARD_ERROR_OF_MEAN|12.8||0.0035|TWO_SIDED|95.0|-66.5|-14.3|||ANOVA|treatment group and HbA1c stratum at screening were factors.||||-14.3|-66.5|0.0035
70878618|NCT03338855|141241766|SUPERIORITY||Least Square (LS) Mean Difference|-1.068|STANDARD_ERROR_OF_MEAN|1.014||0.3047|TWO_SIDED|95.0|-3.183|1.047|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of delta RD (basal vs high insulin) between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||1.047|-3.183|0.3047
70878619|NCT03338855|141241767|SUPERIORITY||LS Mean Difference|-1.705|STANDARD_ERROR_OF_MEAN|0.517||0.0036|TWO_SIDED|95.0|-2.784|-0.625|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of delta EGP (basal vs low insulin) between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||-0.625|-2.784|0.0036
70878620|NCT03338855|141241767|SUPERIORITY||LS Mean Difference|-2.292|STANDARD_ERROR_OF_MEAN|0.409|<|0.0001|TWO_SIDED|95.0|-3.146|-1.438|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of delta EGP (basal vs high insulin) between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||-1.438|-3.146|<0.0001
70878621|NCT03338855|141241768|SUPERIORITY||LS Mean Difference|0.012|STANDARD_ERROR_OF_MEAN|0.009||0.1842|TWO_SIDED|95.0|-0.006|0.03|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of delta RER (basal vs high insulin) between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||0.030|-0.006|0.1842
70958415|NCT02390050|141420671|SUPERIORITY||Difference of LS Means|-0.45|||||TWO_SIDED|95.0|-0.62|-0.28||||||Week 6: Difference in LS Mean change in HbA1c (%) from baseline to Week 6 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.28|-0.62|
70878622|NCT03338855|141241769|SUPERIORITY||LS Mean Difference|-0.023|STANDARD_ERROR_OF_MEAN|0.005||0.0001|TWO_SIDED|95.0|-0.033|-0.013|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of 24-hour RER between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||-0.013|-0.033|0.0001
70878623|NCT03338855|141241770|SUPERIORITY||LS Mean Difference|-0.109|STANDARD_ERROR_OF_MEAN|0.065||0.1095|TWO_SIDED|95.0|-0.245|0.027|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of energy expenditure between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||0.027|-0.245|0.1095
70878624|NCT03338855|141241771|SUPERIORITY||LS Mean Difference|-246.7|STANDARD_ERROR_OF_MEAN|464.3||0.6005|TWO_SIDED|95.0|-1209.5|716.2|||Linear Mixed Effects Model||A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.|Comparison of fat mass between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||716.2|-1209.5|0.6005
70878625|NCT03338855|141241771|SUPERIORITY||LS Mean Difference|-666.5|STANDARD_ERROR_OF_MEAN|301.1||0.0376|TWO_SIDED|95.0|-1291.0|-41.9|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of lean mass between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||-41.9|-1291.0|0.0376
70958416|NCT02390050|141420671|SUPERIORITY||Difference of LS Means|-0.49|||||TWO_SIDED|95.0|-0.66|-0.32||||||Week 6: Difference in LS Mean change in HbA1c (%) from baseline to Week 6 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.32|-0.66|
70878626|NCT03338855|141241772|SUPERIORITY||LS Mean Difference|-1.256|STANDARD_ERROR_OF_MEAN|0.289||0.0003|TWO_SIDED|95.0|-1.854|-0.657|||Linear Mixed Effects Model||A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.|Comparison of total mass between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||-0.657|-1.854|0.0003
70878627|NCT03338855|141241773|SUPERIORITY||LS Mean Difference|-244.301|STANDARD_ERROR_OF_MEAN|165.168||0.1555|TWO_SIDED|95.0|-590.002|101.401|||Linear Mixed Effects Model||A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.|Comparison of FGF21 AUC between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||101.401|-590.002|0.1555
70958417|NCT02390050|141420671|SUPERIORITY||Difference of LS Means|-0.53|||||TWO_SIDED|95.0|-0.7|-0.36||||||Week 6: Difference in LS Mean change in HbA1c (%) from baseline to Week 6 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.36|-0.70|
70878628|NCT00056407|141241781|SUPERIORITY_OR_OTHER||Relative Risk Reduction|23.3|||<|0.0001||95.0|15.6|30.3||The p value is given is for the overall assessment.|Mantel-Cox||Estimation data given are for the overall assessment.|||30.3|15.6|<0.0001
70878629|NCT00056407|141241782|SUPERIORITY_OR_OTHER||Relative Risk Reduction|23.1|||<|0.0001||95.0|15.5|30.0||The p value is given is for the overall assessment.|Mantel-Cox||Estimation data are given are for the overall assessment.|||30.0|15.5|<0.0001
70878630|NCT00056407|141241783|SUPERIORITY_OR_OTHER||Relative Risk Reduction|22.8|||<|0.0001||95.0|15.2|29.8||The p value is given for the overall assessment.|Mantel-Cox||Estimation data are given for the overall assessment.|||29.8|15.2|<0.0001
70878631|NCT00056407|141241806|SUPERIORITY_OR_OTHER||Difference in adjusted means|18.8|||<|0.001||95.0|17.3|20.4|||general linear model, t-test||The adjusted mean difference was calculated as the difference between the adjusted means (-6.1 and 12.7) for the placebo and Dutasteride arms, respectively.|||20.4|17.3|<0.001
70878632|NCT00951808|141241818|SUPERIORITY_OR_OTHER||optimal threshold level of sPLA2|48.0|STANDARD_DEVIATION|5.0|||TWO_SIDED|95.0|38.0|58.0|||||The optimal threshold level (TL) was determined to be the same for all analysis groups.|The optimal threshold level (TL), determined via receiver operating characteristic (ROC) curve analysis, maximizes the difference between the true positive rate (TPR) and the false positive rate (FPR). Since there is no corresponding analytic standard deviation (SD) for this value, we computed a robust SD based upon the interquartile range (IQR)/1.35 from a bootstrap sample of optimal TLs.||58|38|
70878633|NCT00455429|141241822|SUPERIORITY_OR_OTHER|||||||0.6|||||||Cochran-Mantel-Haenszel|||||||0.600
70878634|NCT00455429|141241822|SUPERIORITY_OR_OTHER|||||||0.822|||||||Cochran-Mantel-Haenszel|||||||0.822
70878635|NCT00455429|141241822|SUPERIORITY_OR_OTHER|||||||0.656|||||||Cochran-Mantel-Haenszel|||||||0.656
70878636|NCT00455429|141241823|SUPERIORITY_OR_OTHER||LS Mean difference|-3.4|STANDARD_ERROR_OF_MEAN|2.63||0.427|TWO_SIDED|95.0|-9.7|2.9|||Dunnett-Hsu|||||2.90|-9.70|0.427
70878637|NCT00455429|141241823|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|2.55||0.922|TWO_SIDED|95.0|-7.37|4.82|||Dunnett-Hsu|||||4.82|-7.37|0.922
70878638|NCT00455429|141241823|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.24||0.919|TWO_SIDED|95.0|-6.49|4.21|||Dunnett-Hsu|||||4.21|-6.49|0.919
70878639|NCT00455429|141241824|SUPERIORITY_OR_OTHER||LS Mean difference|3.7|STANDARD_ERROR_OF_MEAN|8.15||0.941|TWO_SIDED|95.0|-15.83|23.18|||Dunnett-Hsu|||||23.18|-15.83|0.941
70878640|NCT00455429|141241824|SUPERIORITY_OR_OTHER||LS Mean Difference|14.2|STANDARD_ERROR_OF_MEAN|8.07||0.196|TWO_SIDED|95.0|-5.12|33.52|||Dunnett-Hsu|||||33.52|-5.12|0.196
70878641|NCT00455429|141241824|SUPERIORITY_OR_OTHER||LS Mean Difference|14.9|STANDARD_ERROR_OF_MEAN|7.08||0.096|TWO_SIDED|95.0|-2.0|31.86|||Dunnett-Hsu|||||31.86|-2.00|0.096
70878642|NCT00455429|141241825|SUPERIORITY_OR_OTHER|||||||0.46|||||||Regression, Logistic|||||||0.460
70878643|NCT00455429|141241825|SUPERIORITY_OR_OTHER|||||||0.479|||||||Regression, Logistic|||||||0.479
70878644|NCT00455429|141241825|SUPERIORITY_OR_OTHER|||||||0.462|||||||Regression, Logistic|||||||0.462
70878645|NCT00455429|141241826|SUPERIORITY_OR_OTHER|||||||0.363|||||||Regression, Logistic|||||||0.363
70878646|NCT00455429|141241826|SUPERIORITY_OR_OTHER|||||||0.968|||||||Regression, Logistic|||||||0.968
70878647|NCT00455429|141241826|SUPERIORITY_OR_OTHER|||||||0.501|||||||Regression, Logistic|||||||0.501
70878648|NCT00455429|141241827|SUPERIORITY_OR_OTHER|||||||0.333|||||||Regression, Logistic|||||||0.333
70878649|NCT00455429|141241827|SUPERIORITY_OR_OTHER|||||||0.527|||||||Regression, Logistic|||||||0.527
70878650|NCT00455429|141241827|SUPERIORITY_OR_OTHER|||||||0.353|||||||Regression, Logistic|||||||0.353
70878651|NCT00455429|141241828|SUPERIORITY_OR_OTHER|||||||0.631|||||||Regression, Logistic|||||||0.631
70878652|NCT00455429|141241828|SUPERIORITY_OR_OTHER|||||||0.523|||||||Regression, Logistic|||||||0.523
70878653|NCT00455429|141241828|SUPERIORITY_OR_OTHER|||||||0.101|||||||Regression, Logistic|||||||0.101
70878654|NCT00455429|141241829|SUPERIORITY_OR_OTHER|||||||0.429|||||||Regression, Logistic|||||||0.429
70878655|NCT00455429|141241829|SUPERIORITY_OR_OTHER|||||||0.206|||||||Regression, Logistic|||||||0.206
70878656|NCT00455429|141241829|SUPERIORITY_OR_OTHER|||||||0.107|||||||Regression, Logistic|||||||0.107
70878657|NCT00455429|141241830|SUPERIORITY_OR_OTHER|||||||0.097|||||||Regression, Logistic|||||||0.097
70878658|NCT00455429|141241830|SUPERIORITY_OR_OTHER|||||||0.077|||||||Regression, Logistic|||||||0.077
70878659|NCT00455429|141241830|SUPERIORITY_OR_OTHER|||||||0.489|||||||Regression, Logistic|||||||0.489
70878660|NCT00455429|141241831|SUPERIORITY_OR_OTHER|||||||0.566|||||||Regression, Logistic|||||||0.566
70878661|NCT00455429|141241831|SUPERIORITY_OR_OTHER|||||||0.382|||||||Regression, Logistic|||||||0.382
70878662|NCT00455429|141241831|SUPERIORITY_OR_OTHER|||||||0.282|||||||Regression, Logistic|||||||0.282
70878663|NCT00455429|141241832|SUPERIORITY_OR_OTHER|||||||0.206|||||||Regression, Logistic|||||||0.206
70878664|NCT00455429|141241832|SUPERIORITY_OR_OTHER|||||||0.433|||||||Regression, Logistic|||||||0.433
70878665|NCT00455429|141241832|SUPERIORITY_OR_OTHER|||||||0.29|||||||Regression, Logistic|||||||0.290
70878666|NCT00455429|141241833|SUPERIORITY_OR_OTHER|||||||0.484|||||||Regression, Logistic|||||||0.484
70878667|NCT00455429|141241833|SUPERIORITY_OR_OTHER|||||||0.952|||||||Regression, Logistic|||||||0.952
70878668|NCT00455429|141241833|SUPERIORITY_OR_OTHER|||||||0.35|||||||Regression, Logistic|||||||0.350
70878669|NCT04351087|141241859|EQUIVALENCE|Power analysis based on (MCID) for the KOOS-Pain, alpha 0.05 \& SD 15 points, 88 patients (44/group) would be required to detect a 9-point difference between treatment groups with 80% power. Due to change in regulatory requirements during accrual, enrollment was halted at 79 patients with 71 meeting inclusion criteria. A repeated power calculation demonstrated that the study achieved 56% power to detect a between-group difference in excess of the 9-point MCID for the KOOS-Pain.|Mean Difference (Final Values)|2.17||||0.69|TWO_SIDED|95.0|-8.57|12.92|||t-test, 2 sided|||||12.92|-8.57|0.69
70878670|NCT05517382|141241882|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||At baseline||||0.20
70878671|NCT05517382|141241882|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||At Post game||||0.59
70878672|NCT05517382|141241882|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||At 3 month||||0.94
70878673|NCT05517382|141241882|SUPERIORITY|||||||0.55|||||||GEE|Controlling for baseline thriving status, this reflects the interaction between the intervention group and time.||||||0.55
70878674|NCT05517382|141241883|SUPERIORITY||Mean Difference (Net)|-0.09||||0.1759|TWO_SIDED|95.0|-0.23|0.04|||Mixed Models Analysis||Group effect.|At post game.||0.04|-0.23|0.1759
70878675|NCT05517382|141241883|SUPERIORITY||Mean Difference (Net)|-0.16||||0.0857|TWO_SIDED|95.0|-0.35|0.02|||Mixed Models Analysis||Group effect.|At 3 month||0.02|-0.35|0.0857
70878676|NCT01641692|141241893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.066||||0.036|TWO_SIDED|95.0|0.004|0.127|||Mixed Models Analysis|||||0.127|0.004|0.036
70878677|NCT01641692|141241893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.331|TWO_SIDED|95.0|-0.03|0.09|||Mixed Models Analysis|||||0.090|-0.030|0.331
70878678|NCT01641692|141241893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.034||||0.272|TWO_SIDED|95.0|-0.027|0.095|||Mixed Models Analysis|||||0.095|-0.027|0.272
70878679|NCT01641692|141241893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088||||0.005|TWO_SIDED|95.0|0.026|0.149|||Mixed Models Analysis|||||0.149|0.026|0.005
70878680|NCT01641692|141241893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011||||0.722|TWO_SIDED|95.0|-0.05|0.073|||Mixed Models Analysis|||||0.073|-0.050|0.722
70878681|NCT01641692|141241893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057||||0.076|TWO_SIDED|95.0|-0.006|0.119|||Mixed Models Analysis|||||0.119|-0.006|0.076
70878682|NCT01641692|141241893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.051||||0.101|TWO_SIDED|95.0|-0.01|0.113|||Mixed Models Analysis|||||0.113|-0.010|0.101
70878683|NCT01641692|141241896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.84|TWO_SIDED|95.0|-2.1|1.7|||Mixed Models Analysis|||||1.7|-2.1|0.840
70878684|NCT01641692|141241896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.553|TWO_SIDED|95.0|-2.4|1.3|||Mixed Models Analysis|||||1.3|-2.4|0.553
70878685|NCT01641692|141241896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.121|TWO_SIDED|95.0|-0.4|3.3|||Mixed Models Analysis|||||3.3|-0.4|0.121
70878686|NCT01641692|141241896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.814|TWO_SIDED|95.0|-2.1|1.7|||Mixed Models Analysis|||||1.7|-2.1|0.814
70878687|NCT01641692|141241896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.683|TWO_SIDED|95.0|-1.5|2.3|||Mixed Models Analysis|||||2.3|-1.5|0.683
70878688|NCT01641692|141241896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.456|TWO_SIDED|95.0|-1.2|2.7|||Mixed Models Analysis|||||2.7|-1.2|0.456
70878689|NCT01641692|141241896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.399|TWO_SIDED|95.0|-2.7|1.1|||Mixed Models Analysis|||||1.1|-2.7|0.399
70878690|NCT01641692|141241897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.03|TWO_SIDED|95.0|0.2|3.2|||Mixed Models Analysis|||||3.2|0.2|0.030
70878691|NCT01641692|141241897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.077|TWO_SIDED|95.0|-0.1|2.8|||Mixed Models Analysis|||||2.8|-0.1|0.077
70878692|NCT01641692|141241897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.01|TWO_SIDED|95.0|0.5|3.5|||Mixed Models Analysis|||||3.5|0.5|0.010
70878693|NCT01641692|141241897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4||||0.002|TWO_SIDED|95.0|0.9|3.9|||Mixed Models Analysis|||||3.9|0.9|0.002
70878694|NCT01641692|141241897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2||||0.005|TWO_SIDED|95.0|0.7|3.7|||Mixed Models Analysis|||||3.7|0.7|0.005
70878695|NCT01641692|141241897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|||<|0.001|TWO_SIDED|95.0|1.2|4.3|||Mixed Models Analysis|||||4.3|1.2|<0.001
70878696|NCT01641692|141241897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.054|TWO_SIDED|95.0|0.0|3.0|||Mixed Models Analysis|||||3.0|0.0|0.054
70958418|NCT02390050|141420671|SUPERIORITY||Difference of LS Means|-0.55|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.34||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates||Week 12: Difference in LS Mean change in HbA1c (%) from baseline to Week 12 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.34|-0.76|< 0.0001
70878697|NCT01641692|141241898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.752|TWO_SIDED|95.0|-1.4|2.0|||Mixed Models Analysis|||||2.0|-1.4|0.752
70958419|NCT02390050|141420671|SUPERIORITY||Difference of LS Means|-0.68|||<|0.0001|TWO_SIDED|95.0|-0.89|-0.47||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates||Week 12: Difference in LS Mean change in HbA1c (%) from baseline to Week 12 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.47|-0.89|< 0.0001
70878698|NCT01641692|141241898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.072|TWO_SIDED|95.0|-0.1|3.2|||Mixed Models Analysis|||||3.2|-0.1|0.072
70878699|NCT01641692|141241898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.503|TWO_SIDED|95.0|-1.1|2.2|||Mixed Models Analysis|||||2.2|-1.1|0.503
70878700|NCT01641692|141241898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.476|TWO_SIDED|95.0|-1.1|2.3|||Mixed Models Analysis|||||2.3|-1.1|0.476
70878701|NCT01641692|141241898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.084|TWO_SIDED|95.0|-0.2|3.2|||Mixed Models Analysis|||||3.2|-0.2|0.084
70878702|NCT01641692|141241898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.97|TWO_SIDED|95.0|-1.8|1.7|||Mixed Models Analysis|||||1.7|-1.8|0.970
70878703|NCT01641692|141241898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.423|TWO_SIDED|95.0|-2.4|1.0|||Mixed Models Analysis|||||1.0|-2.4|0.423
70878704|NCT02461225|141241924|SUPERIORITY||||||<|0.0005|||||||Fisher Exact|||||||<.0005
70878705|NCT02461225|141241925|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
70878706|NCT00484939|141241926|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||||||<0.001
70878707|NCT00484939|141241927|SUPERIORITY_OR_OTHER|||||||0.029|||||||Fisher Exact|||This statistical analysis compared the number of responders in the 2 treatment groups. A responder was defined as any participant with a best overall response of complete response or partial response. There were 28 responders in the bevacizumab + capecitabine group and 14 responders in the capecitabine group.||||0.029
70878708|NCT00484939|141241930|SUPERIORITY_OR_OTHER|||||||0.13|||||||Log Rank|||||||0.130
70878709|NCT00735787|141241951|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Fisher Exact|||The primary null hypothesis for this study was that there was no difference in the proportion of subjects that achieved PGA clear or almost clear at Week 16 between the adalimumab and placebo groups. Analysis was done using a two-sided Fisher's exact test at alpha level=0.05.||||0.014
70878710|NCT01566461|141241971|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||z-test|||||||<0.001
70878711|NCT01566461|141241972|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
70878712|NCT01566461|141241973|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
70878713|NCT01566461|141241974|SUPERIORITY_OR_OTHER|||||||0.926|TWO_SIDED||||||Chi-squared|||||||0.926
70878714|NCT01566461|141241975|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
70878715|NCT01566461|141241976|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
70878716|NCT01566461|141241977|SUPERIORITY_OR_OTHER|||||||0.859|TWO_SIDED||||||t-test, 1 sided|||||||0.859
70878717|NCT01566461|141241978|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Chi-squared|||||||>0.999
70878718|NCT01566461|141241979|SUPERIORITY_OR_OTHER|||||||0.096|TWO_SIDED||||||Chi-squared|||||||0.096
70958420|NCT02390050|141420671|SUPERIORITY||Difference of LS Means|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.01|-0.59||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates||Week 12: Difference in LS Mean change in HbA1c (%) from baseline to Week 12 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.59|-1.01|< 0.0001
70958421|NCT01775124|141420691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6|||||TWO_SIDED|95.0|-2.95|-0.2|||ANOVA|||Descriptive, no hypothesis||-0.2|-2.95|
70958422|NCT00189488|141420721|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference (%)|-17.9||||0.034|TWO_SIDED|95.0|-33.4|-2.4|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|The difference between treatment groups in the percentage of participants with Grade 2 to 4 acute GVHD, adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||-2.4|-33.4|0.034
70958423|NCT00189488|141420722|SUPERIORITY_OR_OTHER||Adjusted Difference (%)|0.5||||0.929|TWO_SIDED|95.0|-11.0|12.1|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|The difference between treatment groups in the percentage of participants with severe GVHD, adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||12.1|-11.0|0.929
70958424|NCT00189488|141420723|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference (%)|-6.5||||0.352|TWO_SIDED|95.0|-19.4|6.4|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|The difference between treatment groups in the percentage of participants with Day 11 Methotrexate GVHD, adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||6.4|-19.4|0.352
70958425|NCT00189488|141420724|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference (%)|-2.6||||0.675|TWO_SIDED|95.0|-14.2|9.0|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|Difference between treatment groups in the percentage of participants with severe oral mucositis, adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|"Participants with Unknown incidence are treated as Yes when constructing the differences, 95% confidence intervals and p-value."||9.0|-14.2|0.675
70878719|NCT01566461|141241980|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
70878720|NCT01566461|141241981|SUPERIORITY_OR_OTHER|||||||0.121|TWO_SIDED||||||Chi-squared|||||||0.121
70958426|NCT00189488|141420725|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|0.5||||0.953|TWO_SIDED|95.0|-1.5|2.5|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||2.5|-1.5|0.953
70958427|NCT00189488|141420726|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference (%)|2.0||||0.797|TWO_SIDED|95.0|-12.5|16.5|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|Difference between treatment groups in the percentage of participants with opioid analgesic use, adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||16.5|-12.5|0.797
70958428|NCT00189488|141420727|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|-5.5||||0.186|TWO_SIDED|95.0|-12.7|1.8|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||1.8|-12.7|0.186
70958429|NCT00189488|141420728|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|-4.1||||0.219|TWO_SIDED|5.0|-12.2|4.0|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||4.0|-12.2|0.219
70958430|NCT02831387|141420729|SUPERIORITY||Mean Difference (Net)|-1.88||||0.749|TWO_SIDED|95.0|-13.696|9.936|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline to Day 29 in the Subject Reported Dry Eye Questionnaire||9.936|-13.696|0.749
70878721|NCT01566461|141241982|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Chi-squared|||||||0.001
70878722|NCT01566461|141241983|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
70878723|NCT01566461|141241984|SUPERIORITY_OR_OTHER|||||||0.095|TWO_SIDED||||||t-test, 1 sided|||||||0.095
70878724|NCT01566461|141241985|SUPERIORITY_OR_OTHER|||||||0.878|TWO_SIDED||||||t-test, 1 sided|||||||0.878
70878725|NCT01566461|141241986|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||t-test, 1 sided|||||||0.590
70878726|NCT01566461|141241987|SUPERIORITY_OR_OTHER|||||||0.302|TWO_SIDED||||||Chi-squared|||||||0.302
70878727|NCT01566461|141241988|SUPERIORITY_OR_OTHER|||||||0.111|TWO_SIDED||||||Chi-squared|||||||0.111
70958431|NCT02831387|141420730|SUPERIORITY||Mean Difference (Net)|-6.6||||0.267|TWO_SIDED|95.0|-18.4|5.3|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline (Visit 2) to Day 29 in Frequency Scores||5.3|-18.4|0.267
70958432|NCT02831387|141420731|SUPERIORITY||Mean Difference (Net)|3.9||||0.495|TWO_SIDED|95.0|-7.6|15.4|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline (Visit 2) to Day 29 in Severity Scores||15.4|-7.6|0.495
70958433|NCT02831387|141420732|SUPERIORITY||Mean Difference (Net)|0.6||||0.316|TWO_SIDED|95.0|-0.6|1.9|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline to Day 29 in Fluorescein Staining of the Cornea||1.9|-0.6|0.316
70958434|NCT02831387|141420733|SUPERIORITY||Mean Difference (Net)|-0.2||||0.823|TWO_SIDED|95.0|-1.9|1.5|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline to Day 29 in Lissamine Green Staining of the Conjunctiva||1.5|-1.9|0.823
70958435|NCT02831387|141420734|SUPERIORITY||Odds Ratio (OR)|1.923|||||TWO_SIDED|95.0|0.515|7.184||||||Statistical Analysis 1 for the Number of participants with at least 20% improvement in symptoms from baseline to Day 29||7.184|0.515|
70958436|NCT02831387|141420735|SUPERIORITY||Mean Difference (Net)|1.666||||0.723|TWO_SIDED|95.0|-7.759|11.092|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline (Visit 2) to Day 15 (Visit 3) in the Subject-reported Dry Eye Symptom Score||11.092|-7.759|0.723
70958437|NCT00192647|141420736|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.2893|TWO_SIDED|95.0|0.88|1.52|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by viral load and country||||1.52|0.88|0.2893
70958438|NCT00192647|141420737|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.91|1.63||||||||1.63|0.91|
70878728|NCT01566461|141241989|SUPERIORITY_OR_OTHER|||||||0.103|TWO_SIDED||||||Chi-squared|||||||0.103
70878729|NCT01566461|141241990|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||t-test, 1 sided|||||||0.049
70878730|NCT00657241|141242010|SUPERIORITY|All hemodynamic variables are continuous and all participants received both treatments, so paired-t analysis could be used. While paired t-tests do not necessarily require a power and sample size analysis, we estimated that 30 subjects were sufficient to detect an 8% difference in CTTI between comparators at p\<0.05 with a conservatively estimated power of 0.8.|||||<|0.05|||||||t-test, 2 sided|||Statistical analysis performed on treatment groups (valsartan or carvedilol CR) at end of treatment period (4 weeks), not on the randomization arms in the crossover design (which controlled for carryover effects of the prior treatment arm).||||<0.05
70958439|NCT00192647|141420738|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68|||||TWO_SIDED|95.0|1.24|2.27||||||Week 4||2.27|1.24|
70958440|NCT00192647|141420738|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64|||||TWO_SIDED|95.0|1.24|2.17||||||Week 8||2.17|1.24|
70958441|NCT00192647|141420738|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88|||||TWO_SIDED|95.0|1.4|2.53||||||Week 12||2.53|1.40|
70878731|NCT00657241|141242012|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|paired t-test||Statistical analysis performed on treatment groups (valsartan or carvedilol CR) at end of treatment period (4 weeks), not on the randomization arms in the crossover design (which controlled for carryover effects of the prior treatment arm).||||0.05
70958442|NCT00192647|141420738|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46|||||TWO_SIDED|95.0|1.08|1.98||||||Week 24||1.98|1.08|
70958443|NCT01828073|141420744|OTHER||Clopper-Pearson Confidence Interval (CI)|31.82|||||TWO_SIDED|90.0|16.0|51.5|||||With the small sample size, the CI estimate tend to be wide.|Point and 90% CI estimates of percentage of full term infants meeting the composite safety endpoint (grade 3/4 adverse event, adverse birth outcome, death)||51.50|16.00|
70958444|NCT01828073|141420744|OTHER||Clopper-Pearson Confidence Interval (CI)|50.0|||||TWO_SIDED|90.0|29.1|70.9|||||With the small sample size, the CI estimate tend to be wide.|Point and 90% CI estimates of percentage of full term infants meeting the composite safety endpoint (grade 3/4 adverse event, death)||70.90|29.10|
70958445|NCT01828073|141420748|OTHER|||||||0.747||||||The study was not powered to do the comparison. This was an exploratory analysis.|Wilcoxon (Mann-Whitney)|||To investigate the relationship between neonatal RAL elimination and UGT1A1 genotype in full term infants.||||0.747
70958446|NCT01828073|141420748|OTHER|||||||0.341||||||The study was not powered to do the comparison. This was an exploratory analysis.|Wilcoxon (Mann-Whitney)|||To investigate the relationship between neonatal RAL elimination and UGT1A1 genotype in LBW infants.||||0.341
70958447|NCT02915302|141420749|NON_INFERIORITY|Non-inferiority was demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the difference in fever rate was \<5%.|Difference in Fever Rate|0.84|||||TWO_SIDED|95.0|-2.13|3.8|||||Fever rate: Fluzone Quadrivalent vaccine (0.5-mL vs. 0.25-mL)|Difference in fever rate was defined as the fever rate following a 0.5-mL dose of Fluzone Quadrivalent vaccine minus the fever rate following a 0.25-mL dose of Fluzone Quadrivalent vaccine.||3.80|-2.13|
70958448|NCT02915302|141420750|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio of GMTs was \>0.667.|GMTs Ratio (A/H1N1)|1.45|||||TWO_SIDED|95.0|1.19|1.77|||||A/H1N1 strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For A/H1N1 strain, GMT ratio was defined as the GMT after 0.5 mL dose(s) of Fluzone Quadrivalent vaccine divided by the GMT after 0.25 mL dose(s) of Fluzone Quadrivalent vaccine.||1.77|1.19|
70958449|NCT02915302|141420750|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio of GMTs was \>0.667.|GMTs Ratio (A/H3N2)|1.5|||||TWO_SIDED|95.0|1.23|1.83|||||A/H3N2 strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For A/H3N2 strain, GMT ratio was defined as the GMT after 0.5 mL dose(s) of Fluzone Quadrivalent vaccine divided by the GMT after 0.25 mL dose(s) of Fluzone Quadrivalent vaccine.||1.83|1.23|
70958450|NCT02915302|141420750|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio of GMTs was \>0.667.|GMTs Ratio (B Victoria lineage)|1.33|||||TWO_SIDED|95.0|1.1|1.62|||||B Victoria lineage strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For B Victoria lineage strain, GMT ratio was defined as the GMT after 0.5 mL dose(s) of Fluzone Quadrivalent vaccine divided by the GMT after 0.25 mL dose(s) of Fluzone Quadrivalent vaccine.||1.62|1.10|
70958451|NCT02915302|141420750|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio of GMTs was \>0.667.|GMTs Ratio (B Yamagata lineage)|1.44|||||TWO_SIDED|95.0|1.2|1.73|||||B Yamagata lineage strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For B Yamagata lineage strain, GMT ratio was defined as the GMT after 0.5 mL dose(s) of Fluzone Quadrivalent vaccine divided by the GMT after 0.25 mL dose(s) of Fluzone Quadrivalent vaccine.||1.73|1.20|
70958452|NCT02915302|141420751|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in SCRs was \>-10%.|Difference in SCR (A/H1N1)|5.1|||||TWO_SIDED|95.0|0.189|10.0|||||A/H1N1 strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For A/H1N1 strain, difference in SCR was defined as SCR after 0.5-mL dose(s) of Fluzone Quadrivalent Vaccine minus SCR after 0.25-mL dose(s) of Fluzone Quadrivalent Vaccine.||10.0|0.189|
70878732|NCT00657241|141242013|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|Paired t-test||Statistical analysis performed on treatment groups (valsartan or carvedilol CR) at end of treatment period (4 weeks), not on the randomization arms in the crossover design (which controlled for carryover effects of the prior treatment arm).||||0.05
70878733|NCT00657241|141242014|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|paired t-test||Statistical analysis performed on treatment groups (valsartan or carvedilol CR) at end of treatment period (4 weeks), not on the randomization arms in the crossover design (which controlled for carryover effects of the prior treatment arm).||||0.05
70958453|NCT02915302|141420751|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in SCRs was \>-10%.|Difference in SCR (A/H3N2)|4.3|||||TWO_SIDED|95.0|-0.283|8.99|||||A/H3N2 strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For A/H3N2 strain, difference in SCR was defined as SCR after 0.5-mL dose(s) of Fluzone Quadrivalent Vaccine minus SCR after 0.25-mL dose(s) of Fluzone Quadrivalent Vaccine.||8.99|-0.283|
70958454|NCT02915302|141420751|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in SCRs was \>-10%.|Difference in SCR (B Victoria lineage)|1.4|||||TWO_SIDED|95.0|-2.78|5.56|||||B Victoria lineage strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For B Victoria lineage strain, difference in SCR was defined as SCR after 0.5-mL dose(s) of Fluzone Quadrivalent Vaccine minus SCR after 0.25-mL dose(s) of Fluzone Quadrivalent Vaccine.||5.56|-2.78|
70958455|NCT02915302|141420751|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in SCRs was \>-10%.|Difference in SCR (B Yamagata lineage)|3.4|||||TWO_SIDED|95.0|-0.465|7.36|||||B Yamagata lineage strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For B Yamagata lineage strain, difference in SCR was defined as SCR after 0.5-mL dose(s) of Fluzone Quadrivalent Vaccine minus SCR after 0.25-mL dose(s) of Fluzone Quadrivalent Vaccine.||7.36|-0.465|
70958456|NCT00645801|141420757|SUPERIORITY|||||||0.05||||||A 2-sided 2 sample t test was used to compare the overall cleanliness score between the 2 treatment groups.|t-test, 2 sided|||Based on the assumption that 70% of patients using PEG plus placebo (group 2) will have good results, by allocating 100 cases in each group, we will have 84% power to detect a difference of 18% or more in the effectiveness of PEG plus lubiprostone combination (group 1) (eg, 70% in group 2 vs. 88% in group 1) at the alpha level of significancelevel of significance.||||0.05
70958457|NCT00645801|141420758|SUPERIORITY||||||<|0.05|||||||2 sided Cochran-Armitage trend test|||||||<0.05
70958458|NCT00645801|141420759|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
70878734|NCT00657241|141242015|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|paired t-test||Statistical analysis performed on treatment groups (valsartan or carvedilol CR) at end of treatment period (4 weeks), not on the randomization arms in the crossover design (which controlled for carryover effects of the prior treatment arm).||||0.05
70878735|NCT02226003|141242052|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-1.16|||<|0.001|TWO_SIDED|95.0|-1.49|-0.84|||Constrained Longitudinal Data Analysis|||||-0.84|-1.49|< 0.001
70878736|NCT02226003|141242052|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-1.24|||<|0.001|TWO_SIDED|95.0|-1.57|-0.91|||Constrained Longitudinal Data Analysis|||||-0.91|-1.57|< 0.001
70878737|NCT02226003|141242053|SUPERIORITY_OR_OTHER||Difference in Percentage vs Placebo|2.6|||||TWO_SIDED|95.0|-11.2|16.4||||||||16.4|-11.2|
70878738|NCT02226003|141242053|SUPERIORITY_OR_OTHER||Difference in Percentage vs Placebo|2.5|||||TWO_SIDED|95.0|-11.4|16.4||||||||16.4|-11.4|
70958459|NCT00705679|141420763|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85||||0.37|TWO_SIDED|95.0|0.61|1.21||The two-sided test a priori threshold for statistical significance is 0.05 against an alternative of 0% effectiveness for estimated effectiveness levels between 33.3% and 50.0%.|Regression, Cox|The Cox proportional-hazards model was stratified by site.|A ratio less than 1 indicates a lower rate of HIV infection in the active arm compared to the placebo arm. A ratio more than 1 indicates a higher rate of HIV infection in the active arm compared to the placebo arm.|The null hypothesis is that the active product will be no more than 25% effective. The trial was designed so that 94 events per pairwise comparison are needed to detect 55% effectiveness while ruling out a lower effectiveness of 25% with 90% power and a false-positive error rate of 0.0025.||1.21|0.61|0.37
70958460|NCT00705679|141420766|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.49||||0.07|TWO_SIDED|95.0|0.97|2.29||The two-sided test a priori threshold for statistical significance is 0.05 against an alternative of 0% effectiveness for estimated effectiveness levels between 33.3% and 50.0%.|Regression, Cox|The Cox proportional-hazards model was stratified by site.|A ratio less than 1 indicates a lower rate of HIV infection in the active arm compared to the placebo arm. A ratio more than 1 indicates a higher rate of HIV infection in the active arm compared to the placebo arm.|The null hypothesis is that the active product will be no more than 25% effective. The trial was designed so that 94 events per pairwise comparison are needed to detect 55% effectiveness while ruling out a lower effectiveness of 25% with 90% power and a false-positive error rate of 0.0025.||2.29|0.97|0.07
70958461|NCT00705679|141420769|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04||||0.81|TWO_SIDED|95.0|0.73|1.49||The two-sided test a priori threshold for statistical significance is 0.05 against an alternative of 0% effectiveness for estimated effectiveness levels between 33.3% and 50.0%.|Regression, Cox|The Cox proportional-hazards model was stratified by site.|A ratio less than 1 indicates a lower rate of HIV infection in the active arm compared to the placebo arm. A ratio more than 1 indicates a higher rate of HIV infection in the active arm compared to the placebo arm.|The null hypothesis is that the active product will be no more than 25% effective. The trial was designed so that 94 events per pairwise comparison are needed to detect 55% effectiveness while ruling out a lower effectiveness of 25% with 90% power and a false-positive error rate of 0.0025.||1.49|0.73|0.81
70958462|NCT00705679|141420770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED||||||Fisher Exact|Two-sided Fisher's Exact Test.||||||0.004
70958463|NCT00932113|141420771|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70958464|NCT00522873|141420811|SUPERIORITY_OR_OTHER||proportion|0.0|||||TWO_SIDED|95.0|0.0|0.0119|||||The number of women who had a biopsy classified as 'hyperplasia or worse' was divided by the number of women with an evaluable biopsy (i.e. classified as 'normal' after 1 year of treatment or as 'hyperplasia or worse' at any time during the study).|Exact 95% confidence interval for proportion of participants with hyperplasia or worse at EoS||0.0119|0.0000|
70878739|NCT02226003|141242055|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-38.94|||<|0.001|TWO_SIDED|95.0|-49.93|-27.96|||Constrained Longitudinal Data Analysis|||||-27.96|-49.93|< 0.001
70878740|NCT02226003|141242055|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-46.05|||<|0.001|TWO_SIDED|95.0|-57.09|-35.02|||Constrained Longitudinal Data Analysis|||||-35.02|-57.09|< 0.001
70878741|NCT02226003|141242056|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-62.42|||<|0.001|TWO_SIDED|95.0|-80.47|-44.37|||Constrained Longitudinal Data Analysis|||||-44.37|-80.47|< 0.001
70958465|NCT00522873|141420812|SUPERIORITY_OR_OTHER||proportion|0.687|||||TWO_SIDED|95.0|0.637|0.734||||||exact 95% confidence intervall (Clopper-Pearson) for proportion of participants with amenorrhea||0.734|0.637|
70958466|NCT00522873|141420812|SUPERIORITY_OR_OTHER||proportion|0.593|||||TWO_SIDED|95.0|0.496|0.684||||||exact 95% confidence intervall (Clopper-Pearson) for proportion of participants with amenorrhea||0.684|0.496|
70958467|NCT00522873|141420813|SUPERIORITY_OR_OTHER||proportion|0.789|||||TWO_SIDED|95.0|0.743|0.83||||||exact 95% confidence intervall (Clopper-Pearson) for proportion of participants with amenorrhea||0.830|0.743|
70958468|NCT00522873|141420813|SUPERIORITY_OR_OTHER||proportion|0.84|||||TWO_SIDED|95.0|0.756|0.904||||||exact 95% confidence intervall (Clopper-Pearson) for proportion of participants with amenorrhea||0.904|0.756|
70958469|NCT00069108|141420867|NON_INFERIORITY_OR_EQUIVALENCE|The pre-specified non-inferiority margin (1.30) was compared with the upper limit of the 95% confidence interval (CI) of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population|Hazard Ratio (HR)|1.03||||0.00584|TWO_SIDED|95.0|0.87|1.24|||Chi-squared||The pre-specified non-inferiority margin (1.30) was compared with the upper limit of the 95% confidence interval (CI) of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population|||1.24|0.87|0.00584
70958470|NCT00069108|141420868|NON_INFERIORITY_OR_EQUIVALENCE|While the study was not designed to demonstrate non-inferiority in PFS based on IRC assessments the pre-specified margin (1.30) was compared with the upper limit of the 95% confidence interval (CI) of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population.|Hazard Ratio (HR)|0.93||||0.00223|TWO_SIDED|95.0|0.74|1.17|||Chi-squared||The pre-specified non-inferiority margin (1.30) was compared with the upper limit of the 95% confidence interval (CI) of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population|||1.17|0.74|0.00223
70958471|NCT00069108|141420869|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.91|1.37||||||||1.37|0.91|
70958472|NCT00069108|141420870|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.95|1.47||||||||1.47|0.95|
70958473|NCT00069108|141420871|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.4028|TWO_SIDED|95.0|0.79|1.77||p-value is for difference between response rates.|Chi-squared|||||1.77|0.79|0.4028
70958474|NCT00069108|141420872|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.2911|TWO_SIDED|95.0|0.81|2.01||p-value is for difference between response rates.|Chi-squared|||||2.01|0.81|0.2911
70958475|NCT00069108|141420873|NON_INFERIORITY_OR_EQUIVALENCE|The pre-specified non-inferiority margin (1.30) was compared with the upper limit of the 95% CI of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population.|Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.87|1.23||||||||1.23|0.87|
70958476|NCT00069108|141420875|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.79|1.68||||||||1.68|0.79|
70958477|NCT00069108|141420876|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.81|1.12||||||||1.12|0.81|
70958478|NCT01415531|141420882|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.3|||<|0.0001|TWO_SIDED|95.0|-7.7|-4.8|||ANCOVA|||||-4.8|-7.7|<0.0001
70958479|NCT02344004|141420903|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||The proportion of participants achieving culture conversion by Month 6 was analyzed using the Cochran-Mantel-Haenszel test, stratified by smoking status and prior multi-drug regimen. The treatment comparison was tested at two-sided significance level of 0.05. The null hypothesis assumed that culture conversion by Month 6 is independent of treatment, and the alternative hypothesis assumed that culture conversion by Month 6 is associated with treatment.|The final analysis of the primary endpoint, the number of participants achieving culture conversion at by Month 6, was performed after the last participants completed Month 6 and his/her Month 6 sputum culture result was available.|||<0.0001
70958480|NCT02344004|141420904|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70878742|NCT02226003|141242056|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-69.65|||<|0.001|TWO_SIDED|95.0|-87.83|-51.46|||Constrained Longitudinal Data Analysis|||||-51.46|-87.83|< 0.001
70878743|NCT02226003|141242057|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.88|||<|0.001|TWO_SIDED|95.0|2.81|16.83|||Logistic regression model|||||16.83|2.81|< 0.001
70878744|NCT02226003|141242057|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.39|||<|0.001|TWO_SIDED|95.0|2.98|18.31|||Logistic regression model|||||18.31|2.98|< 0.001
70878745|NCT02226003|141242058|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-2.0|||<|0.001|TWO_SIDED|95.0|-2.99|-1.01|||Constrained Longitudinal Data Analysis|||||-1.01|-2.99|< 0.001
70878746|NCT02226003|141242058|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-2.1|||<|0.001|TWO_SIDED|95.0|-3.1|-1.11|||Constrained Longitudinal Data Analysis|||||-1.11|-3.10|< 0.001
70878747|NCT02226003|141242059|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-4.44||||0.011|TWO_SIDED|95.0|-7.87|-1.01|||Constrained Longitudinal Data Analysis|||||-1.01|-7.87|0.011
70878748|NCT02226003|141242059|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-6.39|||<|0.001|TWO_SIDED|95.0|-9.83|-2.95|||Constrained Longitudinal Data Analysis|||||-2.95|-9.83|< 0.001
70878749|NCT02226003|141242060|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-1.65||||0.184|TWO_SIDED|95.0|-4.09|0.79|||Constrained Longitudinal Data Analysis|||||0.79|-4.09|0.184
70878750|NCT02226003|141242060|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-2.18||||0.08|TWO_SIDED|95.0|-4.62|0.26|||Constrained Longitudinal Data Analysis|||||0.26|-4.62|0.080
70878751|NCT02467465|141242062|SUPERIORITY|||||||0.175|||||||Wilcoxon (Mann-Whitney)|||||||0.175
70878752|NCT02467465|141242063|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.250
70878753|NCT02467465|141242064|SUPERIORITY|||||||0.466|||||||Wilcoxon (Mann-Whitney)|||||||0.466
70878754|NCT02467465|141242066|SUPERIORITY|||||||0.737|||||||Wilcoxon (Mann-Whitney)|||||||0.737
70878755|NCT02467465|141242067|SUPERIORITY|||||||0.275|||||||Wilcoxon (Mann-Whitney)|||||||0.275
70878756|NCT02467465|141242068|SUPERIORITY|||||||0.066|||||||Wilcoxon (Mann-Whitney)|||||||0.066
70878757|NCT02467465|141242070|SUPERIORITY|||||||0.849|||||||Wilcoxon (Mann-Whitney)|||||||0.849
70878758|NCT02467465|141242071|SUPERIORITY|||||||0.425|||||||Wilcoxon (Mann-Whitney)|||||||0.425
70878759|NCT02467465|141242072|SUPERIORITY|||||||0.487|||||||Wilcoxon (Mann-Whitney)|||||||0.487
70878760|NCT02467465|141242074|SUPERIORITY|||||||0.651|||||||t-test, 1 sided|||||||0.651
70878761|NCT02467465|141242075|SUPERIORITY|||||||0.387|||||||t-test, 1 sided|||||||0.387
70878762|NCT02467465|141242076|SUPERIORITY|||||||0.755|||||||t-test, 1 sided|||||||0.755
70878763|NCT02467465|141242078|SUPERIORITY|||||||0.032|||||||t-test, 1 sided|||||||0.032
70878764|NCT02467465|141242079|SUPERIORITY|||||||0.058|||||||t-test, 1 sided|||||||0.058
70878765|NCT02467465|141242080|SUPERIORITY|||||||0.279|||||||t-test, 1 sided|||||||0.279
70878766|NCT04262232|141242089|SUPERIORITY||Mean Difference (Net)|-1.8||||0.0001|TWO_SIDED|95.0|-2.6|-0.95|||Paired t-test, two-sided||Baseline value minus two weeks post-intervention value.|||-0.95|-2.6|0.0001
70878767|NCT04262232|141242090|SUPERIORITY||Mean Difference (Net)|1.4|||<|0.0001|TWO_SIDED|95.0|1.17|1.63|||Paired t-test, two-sided||Baseline value minus two weeks post-intervention value.|||1.63|1.17|<0.0001
70878768|NCT04262232|141242092|SUPERIORITY||Mean Difference (Net)|-2.8||||0.01|TWO_SIDED|95.0|-4.99|-0.61|||Paired t-test, two-sided||Baseline value minus two weeks post-intervention value.|||-0.61|-4.99|0.01
70878769|NCT04262232|141242094|SUPERIORITY||Mean Difference (Net)|0.5||||0.51|TWO_SIDED|95.0|-1.02|2.02|||Paired t-test, two-sided||Baseline value minus two weeks post-intervention value.|||2.02|-1.02|0.51
70958481|NCT02344004|141420905|SUPERIORITY|||||||0.7804|||||||Mixed Model Repeated Measures (MMRM)|||This was analyzed using a mixed model repeated measures (MMRM) analysis of change from Baseline at Months 4\&6. MMRM included treatment, month, treatment-by-month interaction, combination of smoking status \& prior MDR (4 levels: Yes/Yes, Yes/No, No/Yes, and No/No) as fixed factors, baseline 6MWD as a covariate \& baseline 6MWD-by-month interaction. An unstructured covariance matrix was used for the MMRM.|"* Baseline is defined as the last non-missing value prior to first dose of study drug.~* Statistics were obtained from an mixed-effects model repeated measures (MMRM) model with pattern-mixture modeling of missing values due to dropout, which included treatment, month, the treatment-by-month interaction, and the combination of smoking status and prior multidrug regimen as fixed factors, the baseline 6MWT distance as a covariate and baseline 6MWT distance-by-month interaction. MMRM included postbaseline data through Month 6.~* For baseline, n is the number of participants with a baseline score and at least 1 postbaseline score. For Month 6, n is the number of participants with a baseline score and a postbaseline score at the summarized visit."|||0.7804
70958482|NCT02344004|141420906|SUPERIORITY||Cox Proportional Hazard|3.92|||<|0.0001|TWO_SIDED|95.0|2.01|7.63|||Regression, Cox|||Kaplan Meier estimates for the distribution of time to culture conversion were constructed for treatment arms. The treatment comparison was made using the stratified log rank test for the ITT population. The estimated median time to culture conversion for each treatment arm was not estimable. The time to culture conversion was analyzed using Cox regression model to estimate hazards ratio.||7.63|2.01|<0.0001
70958483|NCT02481947|141420910|NON_INFERIORITY|Non-inferiority margin = 12.6% (pre-specified)||||||0.016||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|||||||0.016
70958484|NCT05249829|141420911|NON_INFERIORITY|Non-inferiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>0.667.|Geometric Mean Ratio|1.73|||||TWO_SIDED|99.0|1.493|2.005||||||Geometric Mean Ratio = GMCmRNA-1273.529/GMCmRNA-1273 against the B.1.1.529 strain at Day 29 after study vaccine administration.||2.005|1.493|
70958485|NCT05249829|141420912|NON_INFERIORITY|Non-inferiority was demonstrated if the lower bound of the 96% CI of the Geometric Mean Ratio was \>0.667.|Geometric Mean Ratio|1.763|||||TWO_SIDED|96.0|1.546|2.01||||||Geometric Mean Ratio = GMCmRNA-1273.529/GMCmRNA-1273 against the B.1.1.529 strain at Day 85 after study vaccine administration.||2.010|1.546|
70958486|NCT05249829|141420913|OTHER|Non-inferiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>0.667. Superiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>1.|Geometric Mean Ratio|1.535|||||TWO_SIDED|99.0|1.409|1.672||||||Geometric Mean Ratio = GMCmRNA-1273.214/GMCmRNA-1273 against the B.1.1.529 strain at Day 29 after study vaccine administration.||1.672|1.409|
70958487|NCT05249829|141420914|OTHER|Non-inferiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>0.667. Superiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>1.|Geometric Mean Ratio|1.713|||||TWO_SIDED|96.0|1.583|1.853||||||Geometric Mean Ratio = GMCmRNA-1273.214/GMCmRNA-1273 against the B.1.1.529 strain at Day 85 after study vaccine administration.||1.853|1.583|
70958488|NCT05249829|141420915|NON_INFERIORITY|Non-inferiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>0.667.|Geometric Mean Ratio|1.048|||||TWO_SIDED|99.0|0.958|1.147||||||Geometric Mean Ratio = GMCmRNA-1273.214/GMCmRNA-1273 against the ancestral strain at Day 29 after study vaccine administration. Reported statistical analysis based upon the number of participants with non-missing data at baseline and the corresponding timepoint (N=1818).||1.147|0.958|
70958489|NCT05249829|141420916|OTHER|Non-inferiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>0.667.|Geometric Mean Ratio|1.104|||||TWO_SIDED|96.0|1.032|1.18||||||Geometric Mean Ratio = GMCmRNA-1273.214/GMCmRNA-1273 against the ancestral strain at Day 85 after study vaccine administration. Reported statistical analysis based upon the number of participants with non-missing data at baseline and the corresponding timepoint (N=1418).||1.180|1.032|
70878770|NCT01975909|141242095|EQUIVALENCE|We hypothesized that the real TMS would improve the performance of SARA (i.e., greater percent decrease of SARA score from baseline) as compared to the sham TMS.||||||0.29|||||||t-test, 2 sided|||||||0.29
70958490|NCT05249829|141420923|SUPERIORITY|Superiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>1.|Geometric Mean Ratio|1.73|||||TWO_SIDED|99.0|1.493|2.005||||||Geometric Mean Ratio = GMCmRNA-1273.529/GMCmRNA-1273 against the B.1.1.529 strain at Day 29 after study vaccine administration.||2.005|1.493|
70958491|NCT05249829|141420923|SUPERIORITY|Superiority was demonstrated if the lower bound of the 96% CI of the Geometric Mean Ratio was \>1.|Geometric Mean Ratio|1.763|||||TWO_SIDED|96.0|1.546|2.01||||||Geometric Mean Ratio = GMCmRNA-1273.529/GMCmRNA-1273 against the B.1.1.529 strain at Day 85 after study vaccine administration. Reported statistical analysis based upon the number of participants with non-missing data at baseline and the corresponding timepoint (N=460).||2.010|1.546|
70958492|NCT02842827|141420958|OTHER|||||||0.3868|||||||Kruskal-Wallis|p-value of the treatment effect was calculated between all dose arms with ≥3 participants||||||0.3868
70958493|NCT02842827|141420959|OTHER|||||||0.7744|||||||Kruskal-Wallis|p-value of the treatment effect was calculated between all dose arms with ≥3 participants||||||0.7744
70958494|NCT02842827|141420960|OTHER|||||||0.508|||||||Kruskal-Wallis|p-value of the treatment effect was calculated between all dose arms with ≥3 participants||||||0.5080
70958495|NCT02842827|141420961|OTHER|||||||0.6109|||||||Kruskal-Wallis|p-value of the treatment effect was calculated between all dose arms with ≥3 participants||||||0.6109
70958496|NCT02842827|141420962|OTHER|||||||0.1151|||||||Kruskal-Wallis|p-value of the treatment effect was calculated between all dose arms with ≥3 participants||||||0.1151
70958497|NCT02842827|141420963|OTHER|||||||0.0791|||||||Kruskal-Wallis|p-value of the treatment effect was calculated between all dose arms with ≥3 participants||||||0.0791
70958498|NCT01815138|141420965|OTHER||Odds Ratio (OR)|0.05|||<|0.05|TWO_SIDED||||||Fisher Exact|||||||<0.05
70958499|NCT01815138|141420966|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
70958500|NCT03426267|141420968|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
70958501|NCT03426267|141420969|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
70958502|NCT00882687|141420975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3235|||||||Wilcoxon rank-sum test|||||||0.3235
70958503|NCT00882687|141420975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9144|||||||Wilcoxon rank-sum test|||||||0.9144
70958504|NCT00882687|141420975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3324|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.3324
70958505|NCT00882687|141420976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5846|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.5846
70958506|NCT00882687|141420976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1493|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.1493
70958507|NCT00882687|141420976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0404|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.0404
70958508|NCT00882687|141420977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0578|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.0578
70958509|NCT00882687|141420977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8988|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.8988
70958510|NCT00882687|141420977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4709|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.4709
70958511|NCT00882687|141420978|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1773|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.1773
70958512|NCT00882687|141420978|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4222|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.4222
70958513|NCT00882687|141420978|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4326|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.4326
70958514|NCT02649946|141420982|SUPERIORITY|TLPP evaluated at 6 months post-index procedure to assess if TLPP of COVERA is superior to that of PTA alone, by direct comparison.|||||<|0.001||||||Test successful if the one-side p-value is less than 0.025 and the result is in favor of the COVERA Vascular Covered Stent.|Chi-squared|||"Hypothesis: The (survival) rate in subjects treated with the COVERA Vascular Covered Stent (following PTA) with respect to TLPP through 6 months is greater than that in subjects treated with PTA alone in the treatment of stenoses in the upper extremity venous outflow of subjects dializing with an AV fistula.~Sample size calculation: 238 randomized subjects \[214 evaluable\] will give 92% power with one-sided type 1 error = 0.025."||||<0.001
70958515|NCT02649946|141420983|NON_INFERIORITY|Non-inferiority Farrington and Manning Exact Test is used to test the primary safety hypothesis. The test is successful if the one-sided p-value is less than 0.025.||||||0.0022|||||||Farrington and Manning|Non-inferiority test with non-inferiority margin of 10%.||"Hypothesis: The safety rate in subjects treated with the COVERA Vascular Covered Stent (following PTA) is non-inferior to the safety rate in subjects treated with PTA alone through 30 days in the treatment of stenotic lesions.~Sample size: 238 randomized subjects \[226 evaluable\] will give 85% power with one-sided type 1 error = 0.025."||||0.0022
70958516|NCT01809002|141421028|NON_INFERIORITY|The primary endpoint tested non-inferiority as compared to collagen nerve cuff and superior to no treatment. Non-inferiority is defined as the lower limit of the 95% CI about the difference of \> -2 and the upper limit of the 95% CI for s2PD for Avance of \< 13 in ITT table.|Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-1.087|1.574|||ANCOVA|||The analysis was performed using a pre-defined standard statistical analysis with a non-response/failure assigned a worst-case scenario value of 16mm.||1.574|-1.087|
70958517|NCT01809002|141421029|SUPERIORITY|||||||0.035|||||||Wilcoxon (Mann-Whitney)|||||||0.035
70958518|NCT01809002|141421029|SUPERIORITY|||||||0.365|||||||Wilcoxon (Mann-Whitney)|||||||0.365
70958519|NCT01809002|141421030|SUPERIORITY|||||||0.915||||||The number and percentage of all treated subjects who recovered s2PD in the target repair at Month 12 (i.e., s2PD of 2 - 15 mm) were summarized by repair type. Differences between the repair types were assessed using a logistic regression analysis.|Regression, Logistic|||Responders were defined as subjects achieving s2PD of 2-15 mm on the target nerve repair.||||0.915
70958520|NCT01809002|141421031|SUPERIORITY||LS Means difference|-2.84|||||TWO_SIDED|95.0|-11.6316|5.9541||Pre-injury baseline was defined as s2PD in the contralateral digit associated with the target digit.|ANCOVA|This analysis was assessed in the ITT population, at Month 12 using the LS Mean differences from a repeated measures ANCOVA model.||||5.9541|-11.6316|
70958521|NCT01809002|141421032|SUPERIORITY|||||||0.792|||||||Kaplan-Meier median and 95% CI|Differences between the repair types were assessed with a KM log-rank test that was appropriate for the handing of interval-censored data.||||||0.792
70958522|NCT01809002|141421033|SUPERIORITY|||||||0.526|||||||Wilcoxon (Mann-Whitney)|This analysis was completed to detect a distribution shift of the MRCC score between repairs with PNA and repairs with nerve cuff at Month 12.||||||0.526
70958523|NCT01809002|141421034|OTHER||Mean Difference (Final Values)|-24.09|||||TWO_SIDED|||||||||"This analysis compares the change in 12 Month Pain VAS scores from Baseline. Missing or incomplete data was extrapolated using a pre-defined repeated measures modeling approach for calculations in this analysis.~This analysis assesses each treatment group for clinically meaningful improvement in VAS from Baseline assuming a Meaningful Clinically Important Difference delta of 20 points (mm)."||||
70958524|NCT01809002|141421036|SUPERIORITY|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
70958525|NCT01809002|141421037|SUPERIORITY|||||||0.037|||||||Wilcoxon (Mann-Whitney)|This analysis was completed utilizing a one-sided Wilcoxon Rank Sum test.||||||0.037
70958526|NCT01809002|141421038|SUPERIORITY|||||||0.021|||||||Wilcoxon (Mann-Whitney)|One-sided Wilcoxon Rank Sum test was utilized for this analysis.||||||0.021
70958527|NCT03102645|141421073|SUPERIORITY||Mean Difference (Final Values)|6.5||||0.07|TWO_SIDED|95.0|-0.5|13.5|||t-test, 2 sided|CROS. DF=14.||CROS test||13.5|-0.5|0.07
70878771|NCT01975909|141242096|EQUIVALENCE|We hypothesized that the real TMS would improve the performance of 25-foot walking test (i.e., greater percent increase of walking speed from baseline) as compared to the sham TMS.||||||0.47|||||||t-test, 2 sided|||||||0.47
70878772|NCT01975909|141242097|EQUIVALENCE|We hypothesized that the real TMS would improve the performance of 9-hole peg test (i.e., greater percent decrease of time to complete the test from baseline) as compared to the sham TMS.||||||0.12|||||||t-test, 2 sided|||||||0.12
70878773|NCT01975909|141242098|EQUIVALENCE|We hypothesized that the real TMS would improve the performance of 90-second walking test (i.e., greater percent increase of walking speed from baseline) as compared to the sham TMS.||||||0.69|||||||t-test, 2 sided|||||||0.69
70878774|NCT01975909|141242099|EQUIVALENCE|We hypothesized that the real TMS would improve the standing postural control stability (i.e., greater percent decrease increase of postural sway speed from baseline) as compared to the sham TMS.||||||0.009|||||||t-test, 2 sided|||||||0.009
70878775|NCT01975909|141242100|EQUIVALENCE|We hypothesized that the real TMS would improve the performance of TUG test (i.e., greater percent decrease of time to complete TUG test from baseline) as compared to the sham TMS.||||||0.18|||||||t-test, 2 sided|||||||0.18
70878776|NCT00670800|141242179|SUPERIORITY_OR_OTHER|||||||0.143||95.0|||||t-test, 2 sided|||||||0.143
70878777|NCT00670800|141242179|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||t-test, 2 sided|||||||0.900
70878778|NCT00670800|141242179|SUPERIORITY_OR_OTHER|||||||0.133||95.0|||||t-test, 2 sided|||||||0.133
70878779|NCT00670800|141242180|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||t-test, 2 sided|||||||0.049
70878780|NCT00670800|141242180|SUPERIORITY_OR_OTHER|||||||0.717||95.0|||||t-test, 2 sided|||||||0.717
70878781|NCT00670800|141242180|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||t-test, 2 sided|||||||0.038
70878782|NCT00670800|141242181|SUPERIORITY_OR_OTHER|||||||0.498||95.0|||||t-test, 2 sided|||||||0.498
70878783|NCT00670800|141242181|SUPERIORITY_OR_OTHER|||||||0.835||95.0|||||t-test, 2 sided|||||||0.835
70878784|NCT00670800|141242181|SUPERIORITY_OR_OTHER|||||||0.606||95.0|||||t-test, 2 sided|||||||0.606
70878785|NCT00670800|141242182|SUPERIORITY_OR_OTHER|||||||0.118||95.0|||||t-test, 2 sided|||||||0.118
70878786|NCT00670800|141242182|SUPERIORITY_OR_OTHER|||||||0.581||95.0|||||t-test, 2 sided|||||||0.581
70878787|NCT00670800|141242182|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||t-test, 2 sided|||||||0.190
70958528|NCT03102645|141421074|SUPERIORITY||Mean Difference (Final Values)|15.2||||0.03|TWO_SIDED|95.0|2.0|28.2|||t-test, 2 sided|CROS test||CROS test||28.2|2.0|0.03
70878788|NCT05027438|141242187|SUPERIORITY||Mean Difference (Net)|-7.58|STANDARD_DEVIATION|5.19|<|0.001|TWO_SIDED||||||Mixed Models Analysis||post-treatment - baseline (negative value indicates reduction of symptoms)|baseline to post-treatment|effect size (f2) = 1.42 (large \>=0.35)|||<0.001
70878789|NCT05027438|141242187|SUPERIORITY||Mean Difference (Net)|-7.06|STANDARD_DEVIATION|4.4|<|0.001|TWO_SIDED||||||Mixed Models Analysis||3-month follow-up - baseline (negative value indicates reduction of symptoms)|baseline to 3-month follow-up|effect size (f2) = 1.54 (large \>=0.35)|||<0.001
70878790|NCT05027438|141242188|SUPERIORITY||Mean Difference (Net)|58.55|STANDARD_DEVIATION|43.98||0.004|TWO_SIDED|||||Bonferroni correction|Friedman test|||% change in medication dose from baseline to post-treatment||||0.004
70878791|NCT05027438|141242188|SUPERIORITY||Mean Difference (Net)|62.26|STANDARD_DEVIATION|54.93||0.005|TWO_SIDED|||||Bonferroni correction|Friedman test|||% change in medication dose from baseline to 3-month follow-up||||0.005
70878792|NCT05027438|141242189|SUPERIORITY||Proportion (%)|31.8||||0.052|TWO_SIDED||||||Cochran's Q test|Bonferroni correction||baseline to post-treatment||||0.052
70878793|NCT05027438|141242189|SUPERIORITY||Proportion (%)|60.0|||<|0.001|TWO_SIDED||||||Cochran's Q test|Bonferroni correction||baseline to 3-month follow-up||||<0.001
70878794|NCT05027438|141242190|SUPERIORITY||Mean Difference (Net)|-16.67|STANDARD_DEVIATION|20.57|<|0.001|TWO_SIDED||||||Mixed Models Analysis||post-treatment - baseline (negative value indicates reduction of symptoms)|baseline to post-treatment|effect size (f2) = 0.54 (large \>=0.35)|||<0.001
70878795|NCT05027438|141242190|SUPERIORITY||Mean Difference (Net)|-17.11|STANDARD_DEVIATION|22.11|<|0.001|TWO_SIDED||||||Mixed Models Analysis||3-month follow-up - baseline (negative value indicates reduction of symptoms)|baseline to 3-month follow-up|effect size (f2) = 0.47 (large \>=0.35)|||<0.001
70878796|NCT05027438|141242191|SUPERIORITY||Mean Difference (Net)|-6.24|STANDARD_DEVIATION|20.34||0.101|TWO_SIDED||||||Mixed Models Analysis||post-treatment - baseline (negative value indicates reduction of symptoms)|baseline to post-treatment|effect size (f2) = 0.10 (small \>=0.02)|||0.101
70878797|NCT05027438|141242191|SUPERIORITY||Mean Difference (Net)|-10.34|STANDARD_DEVIATION|18.28|<|0.001|TWO_SIDED||||||Mixed Models Analysis||3-month follow-up - baseline (negative value indicates reduction of symptoms)|baseline to 3-month follow-up|effect size (f2) = 0.34 (medium; large \>=0.35)|||<0.001
70878798|NCT05027438|141242192|SUPERIORITY||Mean Difference (Net)|5.0|STANDARD_DEVIATION|6.0|<|0.001|TWO_SIDED||||||Mixed Models Analysis||post-treatment - baseline (positive value indicates improvement)|baseline to post-treatment|effect size (f2) = 0.87 (large \>=0.35)|||<0.001
70958529|NCT01413087|141421075|SUPERIORITY|||||||0.483|||||||Log Rank|P value by log-rank test for the difference between treatment groups||||||0.483
70958530|NCT01413087|141421076|SUPERIORITY|||||||0.992|||||||Log Rank|P value by log-rank test for the difference between treatment groups||||||0.992
70958531|NCT00704405|141421088|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|53.6|||<|0.001|TWO_SIDED|95.0|34.5|69.1|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 19.0%) that achieved SVR24 and stratifies by prior treatment response.|||69.1|34.5|<0.001
70958532|NCT00704405|141421088|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|64.4|||<|0.001|TWO_SIDED|95.0|45.2|78.3|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 19.0%) that achieved SVR24 and stratifies by prior treatment response.|||78.3|45.2|<0.001
70958533|NCT00704405|141421088|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|59.0|||<|0.001|TWO_SIDED|95.0|40.2|73.4|||Miettinen and Nurminen||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 19.0%) that achieved SVR24 and stratifies by prior treatment response.|||73.4|40.2|<0.001
70958534|NCT00704405|141421091|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|47.3|||<|0.001|TWO_SIDED|95.0|29.2|63.2|||Miettinen and Nurminen||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 19.0%) that achieved SVR24 and stratifies by prior treatment response.|||63.2|29.2|<0.001
70958535|NCT00704405|141421092|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|82.6|||||TWO_SIDED|95.0|69.5|90.2|||||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 9.5%) that achieved cEVR and stratifies by prior treatment response.|||90.2|69.5|
70958536|NCT00704405|141421092|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|76.1|||||TWO_SIDED|95.0|60.1|86.7|||||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 9.5%) that achieved cEVR and stratifies by prior treatment response.|||86.7|60.1|
70958537|NCT00704405|141421093|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|35.8|||||TWO_SIDED|95.0|15.5|53.4|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of PBO patients (36.6%) with undetectable HCV RNA at Week 48 and stratifies by prior treatment response.|||53.4|15.5|
70958538|NCT03218397|141421100|SUPERIORITY||Difference in means|5.6||||0.013|TWO_SIDED|95.0|1.2|10.0||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first antibiotic modification (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||10|1.2|0.013
70958539|NCT03218397|141421101|SUPERIORITY|||||||0.265||||||alpha = 0.05|Fisher Exact|||||||0.265
70878799|NCT05027438|141242192|SUPERIORITY||Mean Difference (Net)|6.0|STANDARD_DEVIATION|6.0|<|0.001|TWO_SIDED||||||Mixed Models Analysis||3-month follow-up - baseline (positive value indicates improvement)|baseline to 3-month follow-up|effect size (f2) = 0.96 (large \>=0.35)|||<0.001
70878800|NCT05027438|141242193|SUPERIORITY||Mean Difference (Net)|-7.48|STANDARD_DEVIATION|6.08|<|0.001|TWO_SIDED||||||Mixed Models Analysis||post-treatment - baseline (negative value indicates improvement)|Sleep Disturbance - higher scores indicate more sleep disturbance. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10.|effect size (f2) = 1.14 (large \>=0.35)|||<0.001
70878801|NCT05027438|141242193|SUPERIORITY||Mean Difference (Net)|-7.82|STANDARD_DEVIATION|5.62|<|0.001|TWO_SIDED||||||Mixed Models Analysis||3-month follow-up - baseline (negative value indicates improvement)|Sleep Disturbance - higher scores indicate more sleep disturbance. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10.|effect size (f2) = 1.21 (large \>=0.35)|||<0.001
70878802|NCT05027438|141242194|SUPERIORITY||Mean Difference (Net)|0.11|STANDARD_DEVIATION|0.21||0.22|TWO_SIDED||||||Mixed Models Analysis||post-treatment - baseline (positive value indicates improvement)||effect size (f2) = 0.18 (medium \>=0.15)|||0.22
70878803|NCT05027438|141242194|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_DEVIATION|0.12|<|0.001|TWO_SIDED||||||Mixed Models Analysis||3-month follow-up - baseline (positive value indicates improvement)||effect size (f2) = 1.99 (large \>=0.35)|||<0.001
70878804|NCT01921179|141242239|EQUIVALENCE|A repeated measures MANOVA was used to compare the impact of GOALS training versus the BHE training on neurocognitive performance Attention and Executive Function Overall Domain Z Score|||||<|0.01|||||||ANOVA|||||||<0.01
70878805|NCT01921179|141242240|EQUIVALENCE|A repeated measure multivariate analysis of variance (MANOVA) was used to compare neurocognitive performance on Overall Attention /Executive Function overall score at baseline and at 6+ month post-GOALS training follow-up|||||<|0.001|||||||ANOVA|Repeated measure MANOVA was used to compare performance on neurocognitive domain scores at baseline and at 6+ month follow-up post-GOALS training||||||<0.001
70878806|NCT01921179|141242241|EQUIVALENCE|A repeated measures MANOVA was used to compare the impact of GOALS training versus the BHE training on functional performance|||||>|0.05|||||||ANOVA|A repeated measures MANOVA was used to compare the impact of GOALS training versus the BHE training on functional performance||||||>0.05
70878807|NCT01921179|141242242|EQUIVALENCE|A repeated measure multivariate analysis of variance (MANOVA) was used to compare performance on Goal Processing Scale Overall domain scores at baseline and 6+ month post-GOALS training follow-up|||||<|0.001|||||||ANOVA|||||||<0.001
70878808|NCT01921179|141242243|EQUIVALENCE|A repeated measures MANOVA was used to compare the impact of GOALS training versus the BHE training on emotional regulation measures - POMS Total score|||||<|0.05|||||||ANOVA|A repeated measures MANOVA was used to compare the impact of GOALS versus the BHE training on emotional regulation measures - POMS Total score||||||<0.05
70878809|NCT01921179|141242244|EQUIVALENCE|A repeated measure multivariate analysis of variance (MANOVA) was used to compare participants' self-report on POMS Total Mood Disturbance overall score at baseline and 6+ month post-GOALS training follow-up|||||<|0.01|||||||ANOVA|||||||<0.01
70878810|NCT00858442|141242315|NON_INFERIORITY_OR_EQUIVALENCE|"Applies normality test of shapiro Wilks = 0.953, P\> 0.449 in group without PRP and in PRP group shapiro Wilks=0.946, P \> 0.259.~The data were normally distributed, with equal variances (Test of levene: F = 0.1234, P\> 0.99)"|Mean Difference (Final Values)|-2.452|STANDARD_ERROR_OF_MEAN|2.452|>|0.1574|TWO_SIDED|95.0|-7.332|2.428||Applies t-test for equality of means. t = -1.016 is obtained. p\> 0.1574|t-test, 1 sided|||||2.428|-7.332|>0.1574
70878811|NCT00858442|141242316|NON_INFERIORITY_OR_EQUIVALENCE|"Applies normality test of shapiro Wilks =0.972, P\> 0.687 in group without PRP and in PRP group shapiro Wilks = 0.964, P \> 0.410.~The data were normally distributed, with equal variances (Test of levene: F = 3.153, P\> 0.082)"|Mean Difference (Final Values)|-0.27186|STANDARD_ERROR_OF_MEAN|0.50519|>|0.593|TWO_SIDED|95.0|-1.28561|0.74189||Applies t-test for equality of means. t = -0.538 is obtained. p\> 0.593|t-test, 2 sided|||||0.74189|-1.28561|>0.593
70878812|NCT00858442|141242317|NON_INFERIORITY_OR_EQUIVALENCE|"Applies normality test of shapiro Wilks=0.822, P\<0.001 in group without PRP, and in PRP group shapiro Wilks =0.910, P\<0.017.~The data were no normally distributed, with equal variances (Test of levene, F=1.324, P\>0.255)"|||||>|0.398|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Mean rank group without PRP= 28.88 Mean rank group with PRP= 26.31 Z value = -0.027||||||>0.398
70878813|NCT00202644|141242323|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Noninferiority of anagrelide could be concluded if lower limit of 95% Confidence Interval for the difference between treatment groups (Hydroxyurea - Anagrelide) was \> -100 x 10\^9/Liter.|Least Square Mean|-100.5|STANDARD_ERROR_OF_MEAN|39.93|||TWO_SIDED|95.0|-179.42|-21.49||||||||-21.49|-179.42|
70878814|NCT00202644|141242324|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Noninferiority of anagrelide could be concluded if lower limit of 95% Confidence Interval for the difference between treatment groups (Hydroxyurea - Anagrelide) was \> -100 x 10\^9/Liter.|Least Square Mean|-113.1|STANDARD_ERROR_OF_MEAN|37.56|||TWO_SIDED|95.0|-187.4|-38.83||||||Month 3||-38.83|-187.40|
70878815|NCT00202644|141242324|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Noninferiority of anagrelide could be concluded if lower limit of 95% Confidence Interval for the difference between treatment groups (Hydroxyurea - Anagrelide) was \> -100 x 10\^9/Liter.|Least Square Mean|-68.3|STANDARD_ERROR_OF_MEAN|43.83|||TWO_SIDED|95.0|-154.95|18.43||||||Month 36||18.43|-154.95|
70878816|NCT00861146|141242357|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Chi-squared|df = 1||||||<.01
70878817|NCT00861146|141242358|SUPERIORITY_OR_OTHER_LEGACY||mixed model regression analyses (F)|2.04|||>|0.15|||||||mixed model regression analyses|||Drinking outcomes assessed using the timeline follow-back were evaluated with mixed model regression analyses using maximum likelihood estimation. Time was measured in three monthly periods and treated as a repeated factor (due to the fixed time period between estimates).||||> .15
70878818|NCT00861146|141242359|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|df=1||||||<.001
70878819|NCT02981342|141242360|SUPERIORITY|||||||0.0495|||||||Cochran-Mantel-Haenszel|||||||0.0495
70878820|NCT02981342|141242360|SUPERIORITY|||||||0.023|||||||Cochran-Mantel-Haenszel|||||||0.0230
70878821|NCT02981342|141242361|SUPERIORITY|||||||0.0085|||||||Log Rank|||||||0.0085
70878822|NCT02981342|141242361|SUPERIORITY|||||||0.0123|||||||Log Rank|||||||0.0123
70878823|NCT02981342|141242362|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||||||1
70878824|NCT02981342|141242362|SUPERIORITY|||||||0.3017|||||||Cochran-Mantel-Haenszel|||||||0.3017
70878825|NCT02981342|141242367|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||||||1
70958540|NCT03218397|141421102|SUPERIORITY|||||||0.093||||||alpha = 0.05|t-test, 2 sided|T-test for the difference in mean length of stay (days) between treatment arms among subjects alive at 30 days.||||||0.093
70958541|NCT03218397|141421103|SUPERIORITY|||||||0.014||||||alpha = 0.05|Fisher Exact|||||||0.014
70958542|NCT03218397|141421104|SUPERIORITY||Difference in means|7.5||||0.009|TWO_SIDED|95.0|1.9|13.1||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first antibiotic escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||13.1|1.9|0.009
70958543|NCT03218397|141421105|SUPERIORITY||Difference in means|6.5||||0.022|TWO_SIDED|95.0|0.9|12.0||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first gram-negative antibiotic escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||12.0|0.9|0.022
70958544|NCT03218397|141421106|SUPERIORITY||Difference in means|0.7||||0.46|TWO_SIDED|95.0|-1.2|2.7||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first gram-positive antibiotic escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||2.7|-1.2|0.46
70958545|NCT03218397|141421107|SUPERIORITY||Difference in means|4.6||||0.074|TWO_SIDED|95.0|-0.4|9.6||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first antibiotic de-escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||9.6|-0.4|0.074
70958546|NCT03218397|141421108|SUPERIORITY||Difference in means|6.5||||0.008|TWO_SIDED|95.0|1.7|11.2||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first gram-negative antibiotic de-escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||11.2|1.7|0.008
70958547|NCT03218397|141421109|SUPERIORITY||Difference in means|-1.9||||0.37|TWO_SIDED|95.0|-5.9|2.2||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first gram-positive antibiotic de-escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||2.2|-5.9|0.37
70958548|NCT00943111|141421112|NON_INFERIORITY_OR_EQUIVALENCE|The sample size for study was based on expected stability rates of 95% for the Imiglucerase group and 85% for the Eliglustat group, power of 85%, a one-sided significance level of 0.025, a non-inferiority margin of 25%, and a 20% non-evaluable/drop-out rate. Eliglustat was declared non-inferior to Imiglucerase if the lower-bound of the 95% confidence interval for the difference was within the non-inferiority margin of 25%.|Difference in Percentage Stable|-8.8|||||TWO_SIDED|95.0|-17.6|4.2||||||||4.2|-17.6|
70958549|NCT00998335|141421143|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||ANOVA|||Baseline versus 3 months||||0.03
70958550|NCT00409773|141421170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.1|STANDARD_ERROR_OF_MEAN|1.7|<|0.001||95.0|-16.5|-9.8||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-9.8|-16.5|<0.001
70958551|NCT00409773|141421170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.2|STANDARD_ERROR_OF_MEAN|1.7|<|0.001||95.0|-13.6|-6.9||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-6.9|-13.6|<0.001
70958552|NCT00409773|141421170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001||95.0|-11.3|-4.6||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-4.6|-11.3|<0.001
70958553|NCT00409773|141421171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.2|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-9.6|-4.8|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-4.8|-9.6|<0.001
70958554|NCT00409773|141421171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.4|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-7.8|-2.9|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-2.9|-7.8|<0.001
70958555|NCT00409773|141421171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.4|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-6.8|-2.0|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-2.0|-6.8|<0.001
70958556|NCT00409773|141421172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.69||95.0|-5.4|3.3|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum||||3.3|-5.4|0.690
70958557|NCT00409773|141421172|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|2.8||||0.2||95.0|-1.6|7.1|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum||||7.1|-1.6|0.200
70958558|NCT00409773|141421172|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.4||||0.48||95.0|-4.7|3.9|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum||||3.9|-4.7|0.480
70958559|NCT00409773|141421173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.4|STANDARD_ERROR_OF_MEAN|1.3||0.013||95.0|0.7|6.0|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||6.0|0.7|0.013
70958560|NCT00409773|141421173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.3||0.378||95.0|-1.5|3.8|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||3.8|-1.5|0.378
70878826|NCT02981342|141242367|SUPERIORITY|||||||0.3017|||||||Cochran-Mantel-Haenszel|||||||0.3017
70958561|NCT00409773|141421173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|1.3||0.003||95.0|1.3|6.6|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||6.6|1.3|0.003
70958562|NCT00409773|141421174|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.3|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-13.3|-7.3|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-7.3|-13.3|<0.001
70958563|NCT00409773|141421174|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-10.2|-4.3|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-4.3|-10.2|<0.001
70958564|NCT00409773|141421174|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-9.9|-3.9|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-3.9|-9.9|<0.001
70958565|NCT00409773|141421175|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.6||0.809||95.0|-5.7|4.5|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||4.5|-5.7|0.809
70958566|NCT00409773|141421175|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|2.6||0.217||95.0|-1.9|8.4|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||8.4|-1.9|0.217
70878827|NCT02981342|141242369|SUPERIORITY||Hazard Ratio (HR)|1.6||||0.1938|TWO_SIDED|95.0|0.782|3.272|||Log Rank|||||3.272|0.782|0.1938
70878828|NCT02981342|141242369|SUPERIORITY||Hazard Ratio (HR)|1.533||||0.2477|TWO_SIDED|95.0|0.746|3.15|||Log Rank|||||3.150|0.746|0.2477
70878829|NCT02981342|141242371|SUPERIORITY||LSMean Difference|0.65|STANDARD_ERROR_OF_MEAN|0.74||0.383|TWO_SIDED|95.0|-0.84|2.13|||Mixed Models Analysis|||Pain at its Worst in Last 24 Hours||2.13|-0.84|0.383
70878830|NCT02981342|141242371|SUPERIORITY||LSMean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.79||0.692|TWO_SIDED|95.0|-1.91|1.28|||Mixed Models Analysis|||Pain at its Worst in Last 24 Hours||1.28|-1.91|0.692
70878831|NCT02981342|141242371|SUPERIORITY||LSMean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.66||0.469|TWO_SIDED|95.0|-0.85|1.8|||Mixed Models Analysis|||Pain at its Least in Last 24 Hours||1.80|-0.85|0.469
70878832|NCT02981342|141242371|SUPERIORITY||LSMean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.7||0.776|TWO_SIDED|95.0|-1.62|1.22|||Mixed Models Analysis|||Pain at its Least in Last 24 Hours||1.22|-1.62|0.776
70878833|NCT02981342|141242371|SUPERIORITY||LSMean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.7||0.328|TWO_SIDED|95.0|-0.72|2.11|||Mixed Models Analysis|||Pain on the Average||2.11|-0.72|0.328
70878834|NCT02981342|141242371|SUPERIORITY||LSMean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.74||0.954|TWO_SIDED|95.0|-1.45|1.54|||Mixed Models Analysis|||Pain on the Average||1.54|-1.45|0.954
70878835|NCT02981342|141242371|SUPERIORITY||LSMean Difference|0.75|STANDARD_ERROR_OF_MEAN|0.8||0.35|TWO_SIDED|95.0|-0.85|2.36|||Mixed Models Analysis|||Pain Right Now||2.36|-0.85|0.350
70878836|NCT02981342|141242371|SUPERIORITY||LSMean Difference|0.72|STANDARD_ERROR_OF_MEAN|0.85||0.405|TWO_SIDED|95.0|-1.01|2.44|||Mixed Models Analysis|||Pain right now.||2.44|-1.01|0.405
70878837|NCT02981342|141242371|SUPERIORITY||LSMean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.73||0.565|TWO_SIDED|95.0|-1.06|1.91|||Mixed Models Analysis|||Pain Interfered General Activity||1.91|-1.06|0.565
70878838|NCT02981342|141242371|SUPERIORITY||LSMean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.79||0.848|TWO_SIDED|95.0|-1.74|1.43|||Mixed Models Analysis|||Pain Interfered General Activity||1.43|-1.74|0.848
70878839|NCT02981342|141242371|SUPERIORITY||LSMean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.65||0.928|TWO_SIDED|95.0|-1.37|1.25|||Mixed Models Analysis|||Pain Interfered with Mood||1.25|-1.37|0.928
70878840|NCT02981342|141242371|SUPERIORITY||LSMean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.69||0.65|TWO_SIDED|95.0|-1.71|1.08|||Mixed Models Analysis|||Pain Interfered with Mood||1.08|-1.71|0.650
70878841|NCT02981342|141242371|SUPERIORITY||LSMean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.86||0.865|TWO_SIDED|95.0|-1.89|1.6|||Mixed Models Analysis|||Pain Interfered Walking Ability||1.60|-1.89|0.865
70878842|NCT02981342|141242371|SUPERIORITY||LSMean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.92||0.497|TWO_SIDED|95.0|-1.23|2.5|||Mixed Models Analysis|||Pain Interfered Walking Ability||2.50|-1.23|0.497
70958567|NCT00409773|141421175|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|2.6||0.796||95.0|-5.8|4.4|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||4.4|-5.8|0.796
70878843|NCT02981342|141242371|SUPERIORITY||LSMean Difference|0.89|STANDARD_ERROR_OF_MEAN|0.8||0.272|TWO_SIDED|95.0|-0.72|2.5|||Mixed Models Analysis|||Pain Interfered with Normal Work||2.50|-0.72|0.272
70958568|NCT00409773|141421176|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.4|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-12.1|-6.6|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-6.6|-12.1|<0.001
70958569|NCT00409773|141421176|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-8.1|-2.6|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-2.6|-8.1|<0.001
70958570|NCT00409773|141421176|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-8.0|-2.5|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-2.5|-8.0|<0.001
70958571|NCT00409773|141421177|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|1.2||0.042||95.0|0.1|4.8|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||4.8|0.1|0.042
70878844|NCT02981342|141242371|SUPERIORITY||LSMean Difference|0.47|STANDARD_ERROR_OF_MEAN|0.85||0.583|TWO_SIDED|95.0|-1.25|2.19|||Mixed Models Analysis|||Pain Interfered with Normal Work||2.19|-1.25|0.583
70878845|NCT02981342|141242371|SUPERIORITY||LSMean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.82||0.876|TWO_SIDED|95.0|-1.53|1.79|||Mixed Models Analysis|||Pain Interfered with Relations||1.79|-1.53|0.876
70878846|NCT02981342|141242371|SUPERIORITY||LSMean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.88||0.644|TWO_SIDED|95.0|-1.37|2.19|||Mixed Models Analysis|||Pain Interfered with relations.||2.19|-1.37|0.644
70878847|NCT02981342|141242371|SUPERIORITY||LSMean Difference|0.75|STANDARD_ERROR_OF_MEAN|0.85||0.384|TWO_SIDED|95.0|-0.97|2.48|||Mixed Models Analysis|||Pain Interfered with Sleep||2.48|-0.97|0.384
70878848|NCT02981342|141242371|SUPERIORITY||LSMean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.89||0.318|TWO_SIDED|95.0|-0.9|2.71|||Mixed Models Analysis|||||2.71|-0.90|0.318
70878849|NCT02981342|141242371|SUPERIORITY||LSMean Difference|0.81|STANDARD_ERROR_OF_MEAN|0.97||0.407|TWO_SIDED|95.0|-1.15|2.78|||Mixed Models Analysis|||Pain Interfered Enjoyment of Life||2.78|-1.15|0.407
70878850|NCT02981342|141242371|SUPERIORITY||LSMean Difference|0.52|STANDARD_ERROR_OF_MEAN|1.04||0.62|TWO_SIDED|95.0|-1.58|2.62|||Mixed Models Analysis|||Pain Interfered Enjoyment of Life||2.62|-1.58|0.620
70878851|NCT02981342|141242371|SUPERIORITY||LSMean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.7||0.475|TWO_SIDED|95.0|-0.9|1.91|||Mixed Models Analysis|||BPI-Mean Interference Score||1.91|-0.90|0.475
70878852|NCT02981342|141242371|SUPERIORITY||LSMean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.74||0.54|TWO_SIDED|95.0|-1.04|1.96|||Mixed Models Analysis|||BPI-Mean Interference Score||1.96|-1.04|0.540
70878853|NCT02981342|141242372|SUPERIORITY||LSMean Difference|-1.39|STANDARD_ERROR_OF_MEAN|5.98||0.818|TWO_SIDED|95.0|-13.46|10.68|||Mixed Models Analysis|||Global health status||10.68|-13.46|0.818
70878854|NCT02981342|141242372|SUPERIORITY||LSMean Difference|-3.8|STANDARD_ERROR_OF_MEAN|6.06||0.533|TWO_SIDED|95.0|-16.03|8.42|||Mixed Models Analysis|||Global health status||8.42|-16.03|0.533
70878855|NCT02981342|141242372|SUPERIORITY||LSMean Difference|-2.79|STANDARD_ERROR_OF_MEAN|6.75||0.681|TWO_SIDED|95.0|-16.4|10.82|||Mixed Models Analysis|||Functional Scales: Physical functioning||10.82|-16.40|0.681
70878856|NCT02981342|141242372|SUPERIORITY||LSMean Difference|-9.02|STANDARD_ERROR_OF_MEAN|6.75||0.189|TWO_SIDED|95.0|-22.63|4.59|||Mixed Models Analysis|||Functional Scales: Physical functioning||4.59|-22.63|0.189
70958572|NCT00409773|141421177|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-0.2|4.5|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||4.5|-0.2|<0.001
70958573|NCT00409773|141421177|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-7.0|4.0|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||4.0|-7.0|<0.001
70878857|NCT02981342|141242372|SUPERIORITY||LSMean Difference|0.96|STANDARD_ERROR_OF_MEAN|9.54||0.921|TWO_SIDED|95.0|-18.29|20.21|||Mixed Models Analysis|||Functional Scales: Role functioning||20.21|-18.29|0.921
70878858|NCT02981342|141242372|SUPERIORITY||LSMean Difference|0.01|STANDARD_ERROR_OF_MEAN|9.62||0.999|TWO_SIDED|95.0|-19.4|19.42|||Mixed Models Analysis|||Functional Scales: Role functioning.||19.42|-19.40|0.999
70878859|NCT02981342|141242372|SUPERIORITY||LSMean Difference|-4.26|STANDARD_ERROR_OF_MEAN|6.91||0.541|TWO_SIDED|95.0|-18.2|9.68|||Mixed Models Analysis|||Functional Scales: Emotional functioning||9.68|-18.20|0.541
70878860|NCT02981342|141242372|SUPERIORITY||LSMean Difference|-6.95|STANDARD_ERROR_OF_MEAN|7.05||0.33|TWO_SIDED|95.0|-21.17|7.27|||Mixed Models Analysis|||Functional Scales: Emotional functioning||7.27|-21.17|0.330
70878861|NCT02981342|141242372|SUPERIORITY||LSMean Difference|-2.04|STANDARD_ERROR_OF_MEAN|6.29||0.747|TWO_SIDED|95.0|-14.74|10.66|||Mixed Models Analysis|||Functional Scales: Cognitive Functioning||10.66|-14.74|0.747
70878862|NCT02981342|141242372|SUPERIORITY||LSMean Difference|-5.25|STANDARD_ERROR_OF_MEAN|6.43||0.419|TWO_SIDED|95.0|-18.22|7.73|||Mixed Models Analysis|||Functional Scales: Cognitive functioning||7.73|-18.22|0.419
70958574|NCT00409773|141421178|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-11.6|-6.0|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-6.0|-11.6|<0.001
70958575|NCT00409773|141421178|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-8.2|-2.5|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-2.5|-8.2|<0.001
70958576|NCT00409773|141421178|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.9|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-8.7|-3.1|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-3.1|-8.7|<0.001
70878863|NCT02981342|141242372|SUPERIORITY||LSMean Difference|-4.02|STANDARD_ERROR_OF_MEAN|7.53||0.596|TWO_SIDED|95.0|-19.23|11.19|||Mixed Models Analysis|||Functional Scales: Social functioning||11.19|-19.23|0.596
70878864|NCT02981342|141242372|SUPERIORITY||LSMean Difference|-19.12|STANDARD_ERROR_OF_MEAN|7.71||0.017|TWO_SIDED|95.0|-34.68|-3.55|||Mixed Models Analysis|||Functional Scales: Social functioning||-3.55|-34.68|0.017
70878865|NCT02981342|141242372|SUPERIORITY||LSMean Difference|-0.77|STANDARD_ERROR_OF_MEAN|7.57||0.919|TWO_SIDED|95.0|-16.03|14.49||Social Scales: Fatigue|Mixed Models Analysis|||Symptoms Scales: Fatigue||14.49|-16.03|0.919
70878866|NCT02981342|141242372|SUPERIORITY||LSMean Difference|8.48|STANDARD_ERROR_OF_MEAN|7.54||0.267|TWO_SIDED|95.0|-6.72|23.69|||Mixed Models Analysis|||Symptom Scales: Fatigue||23.69|-6.72|0.267
70878867|NCT02981342|141242372|SUPERIORITY||LSMean Difference|-1.45|STANDARD_ERROR_OF_MEAN|8.54||0.866|TWO_SIDED|95.0|-18.66|15.77|||Mixed Models Analysis|||Symptom Scales: Nausea and Vomiting||15.77|-18.66|0.866
70878868|NCT02981342|141242372|SUPERIORITY||LSMean Difference|-3.9|STANDARD_ERROR_OF_MEAN|8.59||0.652|TWO_SIDED|95.0|-21.23|13.43|||Mixed Models Analysis|||Symptom Scales: Nausea and Vomiting||13.43|-21.23|0.652
70878869|NCT02981342|141242372|SUPERIORITY||LSMean Difference|7.11|STANDARD_ERROR_OF_MEAN|8.67||0.417|TWO_SIDED|95.0|-10.39|24.6|||Mixed Models Analysis|||Symptom Scales: Pain||24.60|-10.39|0.417
70958577|NCT00409773|141421179|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.0|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-17.6|-10.5|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-10.5|-17.6|<0.001
70878870|NCT02981342|141242372|SUPERIORITY||LSMean Difference|4.36|STANDARD_ERROR_OF_MEAN|8.69||0.618|TWO_SIDED|95.0|-13.16|21.89|||Mixed Models Analysis|||Symptom Scales: Pain||21.89|-13.16|0.618
70878871|NCT02981342|141242372|SUPERIORITY||LSMean Difference|-10.84|STANDARD_ERROR_OF_MEAN|8.44||0.206|TWO_SIDED|95.0|-27.85|6.18|||Mixed Models Analysis|||Symptom Scales: Dyspnoea||6.18|-27.85|0.206
70878872|NCT02981342|141242372|SUPERIORITY||LSMean Difference|4.86|STANDARD_ERROR_OF_MEAN|8.4||0.566|TWO_SIDED|95.0|-12.08|21.8|||Mixed Models Analysis|||Symptom Scales: Dyspnoea||21.80|-12.08|0.566
70878873|NCT02981342|141242372|SUPERIORITY||LSMean Difference|-7.02|STANDARD_ERROR_OF_MEAN|7.93||0.38|TWO_SIDED|95.0|-23.01|8.96|||Mixed Models Analysis|||Symptom Scales: Insomnia||8.96|-23.01|0.380
70878874|NCT02981342|141242372|SUPERIORITY||LSMean Difference|1.52|STANDARD_ERROR_OF_MEAN|7.99||0.85|TWO_SIDED|95.0|-14.6|17.64|||Mixed Models Analysis|||Symptom Scales: Insomnia||17.64|-14.60|0.850
70878875|NCT02981342|141242372|SUPERIORITY||LSMean Difference|-2.79|STANDARD_ERROR_OF_MEAN|8.91||0.756|TWO_SIDED|95.0|-20.78|15.21|||Mixed Models Analysis|||Symptom Scales: Appetite loss||15.21|-20.78|0.756
70878876|NCT02981342|141242372|SUPERIORITY||LSMean Difference|3.02|STANDARD_ERROR_OF_MEAN|9.31||0.747|TWO_SIDED|95.0|-15.77|21.82|||Mixed Models Analysis|||Symptom Scales: Appetite loss||21.82|-15.77|0.747
70878877|NCT02981342|141242372|SUPERIORITY||LSMean Difference|9.47|STANDARD_ERROR_OF_MEAN|9.23||0.311|TWO_SIDED|95.0|-9.16|28.09|||Mixed Models Analysis|||Symptom Scales: Constipation||28.09|-9.16|0.311
70878878|NCT02981342|141242372|SUPERIORITY||LSMean Difference|-9.97|STANDARD_ERROR_OF_MEAN|9.3||0.29|TWO_SIDED|95.0|-28.75|8.8|||Mixed Models Analysis|||Symptom Scales: Constipation||8.80|-28.75|0.290
70958578|NCT00409773|141421179|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.7|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-13.2|-6.1|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-6.1|-13.2|<0.001
70878879|NCT02981342|141242372|SUPERIORITY||LSMean Difference|-10.57|STANDARD_ERROR_OF_MEAN|10.58||0.323|TWO_SIDED|95.0|-31.93|10.78|||Mixed Models Analysis|||Symptom Scales: Diarrhoea||10.78|-31.93|0.323
70878880|NCT02981342|141242372|SUPERIORITY||LSMean Difference|-4.8|STANDARD_ERROR_OF_MEAN|10.54||0.651|TWO_SIDED|95.0|-26.08|16.48|||Mixed Models Analysis|||Symptom Scales: Diarrhoea||16.48|-26.08|0.651
70878881|NCT02981342|141242372|SUPERIORITY||LSMean Difference|1.51|STANDARD_ERROR_OF_MEAN|7.47||0.841|TWO_SIDED|95.0|-13.57|16.59|||Mixed Models Analysis|||Symptom Scales: Financial Difficulties||16.59|-13.57|0.841
70878882|NCT02981342|141242372|SUPERIORITY||LSMean Difference|7.26|STANDARD_ERROR_OF_MEAN|7.57||0.344|TWO_SIDED|95.0|-8.03|22.54|||Mixed Models Analysis|||Symptom Scales: Financial Difficulties||22.54|-8.03|0.344
70878883|NCT01466348|141242377|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.6||||0.0008|TWO_SIDED|95.0|1.5|5.6|||ANOVA|No baseline covariate adjustment was carried out.|A positive difference favors the paracetamol/ caffeine treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.||5.6|1.5|0.0008
70878884|NCT01466348|141242378|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.5|||<|0.0001|TWO_SIDED|95.0|4.5|8.4|||ANOVA|No baseline covariate adjustment was applied.|A positive difference favors the paracetamol/ caffeine treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.||8.4|4.5|<0.0001
70878885|NCT03989440|141242399|SUPERIORITY||LS Mean Difference|0.54||||0.59|TWO_SIDED|95.0|-1.48|2.55|||Mixed Models Analysis|||||2.55|-1.48|0.59
70958579|NCT00409773|141421179|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.5|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-12.0|-4.9|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-4.9|-12.0|<0.001
70878886|NCT03989440|141242400|SUPERIORITY||LS Mean Difference|-1.56||||0.13|TWO_SIDED|95.0|-3.62|0.5|||Mixed Models Analysis|||||0.50|-3.62|0.13
70958580|NCT00409773|141421180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-14.0|-8.0|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-8.0|-14.0|<0.001
70958581|NCT00409773|141421180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.4|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-9.4|-3.3|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-3.3|-9.4|<0.001
70958582|NCT00409773|141421180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.7|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-8.7|-2.7|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-2.7|-8.7|<0.001
70958583|NCT00409773|141421181|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.5|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-15.0|-8.1|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-8.1|-15.0|<0.001
70958584|NCT00409773|141421181|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-10.4|-3.6|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-3.6|-10.4|<0.001
70958585|NCT00409773|141421181|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.7|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-11.2|-4.3|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-4.3|-11.2|<0.001
70958586|NCT00409773|141421184|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-2.9||||0.42||95.0|-11.0|5.0|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum||||5.0|-11.0|0.420
70958587|NCT00409773|141421184|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.9||||0.555||95.0|-9.5|7.2|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum||||7.2|-9.5|0.555
70878887|NCT03989440|141242401|SUPERIORITY||LS Mean Difference|-1.16||||0.16|TWO_SIDED|95.0|-2.81|0.5|||Mixed Models Analysis|||||0.50|-2.81|0.16
70958588|NCT00409773|141421184|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|2.3||||0.41||95.0|-5.1|9.6|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum||||9.6|-5.1|0.410
70958589|NCT00153062|141421185|NON_INFERIORITY_OR_EQUIVALENCE|The pre-defined non-inferiority margin of 1.075|Hazard Ratio (HR)|1.01||||0.783|TWO_SIDED|95.0|0.92|1.11|||Cox Proportional Hazard model|Cox proportional hazards model with age, baseline diabetes status, baseline ACE-I use, and baseline modified Rankin score as covariates||ASA+ER-DP vs clopidogrel||1.11|0.92|0.7830
70958590|NCT00153062|141421186|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.8292|TWO_SIDED|95.0|0.92|1.07|||Cox Proportional Hazard model|Cox proportional hazards model with age, baseline diabetes status, baseline ACE-I use, and baseline modified Rankin score as covariates||ASA+ER-DP vs Clopidogrel||1.07|0.92|0.8292
70958591|NCT00153062|141421187|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.1073|TWO_SIDED|95.0|0.87|1.01|||Cox Proportional Hazard model|Cox proportional hazards model with age, baseline diabetes status, baseline ACE-I use, and baseline modified Rankin score as covariates.||Telmisartan vs Placebo||1.01|0.87|0.1073
70958592|NCT00153062|141421188|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.1007|TWO_SIDED|95.0|0.65|1.04|||Cox Proportional Hazard model|Cox proportional hazards model with age, baseline ACE-I use, and baseline modified Rankin score as covariates||Telmisartan vs Placebo||1.04|0.65|0.1007
70958593|NCT00153062|141421189|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.2312|TWO_SIDED|95.0|0.86|1.04|||Cox Proportional Hazard model|Cox proportional hazards model with age, baseline diabetes status, baseline ACE-I use, and baseline Modified Rankin score as covariates||Telmisartan vs placebo||1.04|0.86|0.2312
70958594|NCT01919814|141421203|SUPERIORITY||||||>|0.05||||||Threshold P-Value was 0.05|t-test, 2 sided|||||||>0.05
70878888|NCT03989440|141242402|SUPERIORITY||% Difference in responder rate|-9.3||||0.68|TWO_SIDED|95.0|-43.3|25.4|||Fisher Exact|||||25.4|-43.3|0.68
70958595|NCT00275262|141421207|SUPERIORITY_OR_OTHER|||||||0.125|||||||ANOVA|The statistical method used for a 1-way ANOVA between treatment groups.||The final on treatment values were included in the analysis.||||0.125
70958596|NCT00275262|141421208|SUPERIORITY_OR_OTHER|||||||0.299|||||||ANOVA|The statistical method used for a 1-way ANOVA between treatment groups.||The final on treatment values were included in the analysis.||||0.299
70958597|NCT02164383|141421213|SUPERIORITY||Mean Difference (Final Values)|1.82||||0.85|TWO_SIDED||||||ANOVA||ANOVA results: F(1,28)=.04, p=.85, partial eta-squared (as a measure of effect size) = .001|||||.85
70958598|NCT00666679|141421272|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.05||||0.033||95.0|0.0|0.09|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|Least-Squares Means for average change from baseline are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|||0.09|0.00|0.033
70958599|NCT00666679|141421273|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|-0.15||||0.005||95.0|-0.26|-0.05|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|Least-Squares Means for average change from baseline are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|||-0.05|-0.26|0.005
70878889|NCT01955161|141242452|SUPERIORITY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.47||0.9591|TWO_SIDED|95.0|-0.59|1.26||Corrected for multiplicity|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.||1.26|-0.59|0.9591
70878890|NCT01955161|141242452|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.47||1|TWO_SIDED|95.0|-0.88|0.98||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.||0.98|-0.88|1.000
70878891|NCT01955161|141242453|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.66||1|TWO_SIDED|95.0|-1.37|1.21||Corrected for multiplicity according toe the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A positive mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.||1.21|-1.37|1.000
70878892|NCT01955161|141242453|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.66||1|TWO_SIDED|95.0|-1.29|1.31||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A positive mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.||1.31|-1.29|1.000
70958600|NCT00666679|141421274|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|-0.09||||0.015||95.0|-0.17|-0.02|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|Least-Squares Means for average change from baseline are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|||-0.02|-0.17|0.015
70958601|NCT00666679|141421275|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|-0.6||||0.073||95.0|-1.26|0.06|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|Least-Squares Means for average change from baseline are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|||0.06|-1.26|0.073
70958602|NCT00666679|141421276|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|6.08||||0.004||95.0|1.94|10.23|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction and period.|Least-Squares Means for average percentage of days are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction and period.|||10.23|1.94|0.004
70958603|NCT00666679|141421277|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|-5.43|||<=|0.001||95.0|-8.67|-2.19|||ANCOVA|Model with terms for patient, treatment and period.|Least-Squares Means for percentage of days are derived from ANCOVA model with terms for patient, treatment and period.|||-2.19|-8.67|<=0.001
70958604|NCT00666679|141421278|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|-0.07||||0.013||95.0|-0.12|-0.01|||Mixed Models Analysis|Model with fixed effects for treatment, period and baseline covariate.|Least-Squares Means for change from baseline are derived from mixed model with terms for treatment, period and baseline covariate.|||-0.01|-0.12|0.013
70958605|NCT00666679|141421279|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.08||||0.002||95.0|0.03|0.13|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|Least-Squares Means for average change from baseline are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|||0.13|0.03|0.002
70958606|NCT05062759|141421289|OTHER||Geometric Least square (LS) mean ratio|0.65|||||TWO_SIDED|90.0|0.43|0.98||||||Influenza A H1N1 Ratio of placebo over tezepelumab. Results based on ANCOVA model.||0.98|0.43|
70958607|NCT05062759|141421289|OTHER||Geometeric LS mean ratio|0.83|||||TWO_SIDED|90.0|0.6|1.15||||||Influenza B Yamagata Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.15|0.60|
70878893|NCT01955161|141242454|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.09||1|TWO_SIDED|95.0|-0.15|0.2||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.||0.20|-0.15|1.000
70958608|NCT05062759|141421289|OTHER||Geometric LS mean ratio|0.99|||||TWO_SIDED|90.0|0.71|1.37||||||Influenza B Victoria Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.37|0.71|
70958609|NCT05062759|141421290|OTHER||Geometeric LS mean ratio|0.73|||||TWO_SIDED|90.0|0.42|1.28||||||Influenza A H1N1 Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.28|0.42|
70958610|NCT05062759|141421290|OTHER||Geometeric LS mean ratio|1.25|||||TWO_SIDED|90.0|0.72|2.17||||||Influenza A H3N2 Ratio of placebo over tezepelumab. Results based on ANCOVA model||2.17|0.72|
70958611|NCT05062759|141421290|OTHER||Geometric LS mean ratio|1.23|||||TWO_SIDED|90.0|0.73|2.07||||||Influenza B Victoria Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||2.07|0.73|
70878894|NCT01955161|141242454|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.09||1|TWO_SIDED|95.0|-0.34|0.02||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, ADAS-cog total score and either ADCS-ADL23 total score or ADCS CGIC had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.||0.02|-0.34|1.000
70878895|NCT01245270|141242463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||"For the incremental area under the curve (AUCi), only the extent of interpolated values above baseline contributed.~Values obtained following the control and extract capsules were compared by paired t-tests."|t-test, 2 sided|||||||0.003
70878896|NCT01245270|141242464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.028||95.0||||For incremental area under the curve (AUCi), only the extent of interpolated values above baseline contributed. Values obtained following the control and extract capsules were compared by paired t-tests.|t-test, 2 sided|||||||0.028
70958612|NCT05062759|141421290|OTHER||Geometeric LS mean ratio|0.89|||||TWO_SIDED|90.0|0.54|1.48||||||Influenza B Yamagata Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.48|0.54|
70958613|NCT05062759|141421291|OTHER||Geometeric LS mean ratio|0.74|||||TWO_SIDED|90.0|0.52|1.04||||||Influenza A H1N1 Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.04|0.52|
70958614|NCT05062759|141421291|OTHER||Geometeric LS mean ratio|0.96|||||TWO_SIDED|90.0|0.72|1.29||||||Influenza B Yamagata Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.29|0.72|
70958615|NCT05062759|141421291|OTHER||Geometric LS mean ratio|1.03|||||TWO_SIDED|90.0|0.73|1.46||||||Influenza B Victoria Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.46|0.73|
70958616|NCT05062759|141421292|OTHER||Geometeric LS mean ratio|0.79|||||TWO_SIDED|90.0|0.51|1.25||||||Influenza A H1N1 Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.25|0.51|
70958617|NCT05062759|141421292|OTHER||Geometeric LS mean ratio|0.76|||||TWO_SIDED|90.0|0.42|1.28||||||Influenza A H3N2 Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.28|0.42|
70958618|NCT05062759|141421292|OTHER||Geometric LS mean ratio|0.99|||||TWO_SIDED|90.0|0.49|1.99||||||Influenza B Victoria Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.99|0.49|
70958619|NCT05062759|141421292|OTHER||Geometeric LS mean ratio|1.03|||||TWO_SIDED|90.0|0.7|1.52||||||Influenza B Yamagata Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.52|0.70|
70958620|NCT00477334|141421349|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.26||||0.4161|TWO_SIDED|95.0|-0.4|0.98|||Hodges-Lehman Shift Model||Difference in time to healing= time to healing for Famciclovir-time to healing for Placebo. Hodges-Lehman shift model is used to estimate the difference in treatment effect. P-value is from the Wilcoxon rank-sum test.|Participants who discontinued from the study before healing of non-aborted lesions was confirmed and participants who completed the study 21 days since treatment initiation without non-aborted lesion stages and without a final assessment on aborted lesion status are imputed according to the distribution of the time to healing among the subjects in the placebo group whose time to healing is greater than or equal to the observed discontinuation time. (Censor time)||0.98|-0.40|0.4161
70878897|NCT02432846|141242527|OTHER|Exploratory superiority (non-powered)|Hazard Ratio (HR)|0.978||||0.964|TWO_SIDED|95.0|0.371|2.579|||Log Rank|||||2.579|0.371|0.964
70878898|NCT02432846|141242527|OTHER|Exploratory superiority (non-powered)|Hazard Ratio (HR)|0.619||||0.163|TWO_SIDED|95.0|0.314|1.222|||Log Rank|||||1.222|0.314|0.163
70958621|NCT00477334|141421349|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.01||||0.9372|TWO_SIDED|95.0|0.74|1.39|||Kaplan-Meier & Cox Regression||"Hazard ratio in time to healing=hazard rate of Famciclovir/hazard rate of Placebo.~Based on Cox proportional hazards model with treatment, pooled center and gender as explanatory variables."|Participants who discontinued from the study before healing of non-aborted lesions was confirmed and participants who completed the study after 21 days since treatment initiation without non-aborted lesion stages and without a final assessment on aborted lesion status were censored at the time of the last clinical lesion observation.||1.39|0.74|0.9372
70878899|NCT02432846|141242527|OTHER|Exploratory superiority (non-powered)|Hazard Ratio (HR)|0.732||||0.25|TWO_SIDED|95.0|0.421|1.27|||Log Rank|||||1.270|0.421|0.250
70878900|NCT02432846|141242528|OTHER|Exploratory superiority (non-powered)|Hazard Ratio (HR)|0.756||||0.596|TWO_SIDED|95.0|0.268|2.134|||Log Rank|||||2.134|0.268|0.596
70878901|NCT02432846|141242528|OTHER|Exploratory superiority (non-powered)|Hazard Ratio (HR)|0.661||||0.285|TWO_SIDED|95.0|0.308|1.418|||Log Rank|||||1.418|0.308|0.285
70878902|NCT02432846|141242528|OTHER|Exploratory superiority (non-powered)|Hazard Ratio (HR)|0.699||||0.24|TWO_SIDED|95.0|0.378|1.29|||Log Rank|||||1.290|0.378|0.240
70878903|NCT02432846|141242529|OTHER|Exploratory superiority (non-powered)|||||=|0.812|||||||Log Rank|||||||= 0.812
70878904|NCT02432846|141242530|OTHER|Exploratory superiority (non-powered)|||||=|0.861|||||||Log Rank|||||||= 0.861
70878905|NCT01770379|141242542|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.2001|TWO_SIDED|95.0|0.79|3.03|||Regression, Logistic|||||3.03|0.79|0.2001
70958622|NCT03486457|141421366|SUPERIORITY||Difference in percentage of participants|32.35|STANDARD_ERROR_OF_MEAN|5.05|<|0.0001|TWO_SIDED|95.0|22.45|42.25|||Normal approximation|||The normal approximation to the difference in binomial proportions was used to test the difference between tofacitinib 5 mg BID and placebo and to generate 95% CI and p-value for the difference in response rates.||42.25|22.45|<0.0001
70958623|NCT03486457|141421367|SUPERIORITY||Difference in percentage of participants|15.44|STANDARD_ERROR_OF_MEAN|4.79||0.0013|TWO_SIDED|95.0|6.05|24.83|||Normal approximation|||Week 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||24.83|6.05|0.0013
70878906|NCT01770379|141242542|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.1574|TWO_SIDED|95.0|0.83|3.15|||Regression, Logistic|||||3.15|0.83|0.1574
70878907|NCT03045887|141242566|OTHER||Ratio|0.41|STANDARD_ERROR_OF_MEAN|0.243|||TWO_SIDED|90.0|0.27|0.61|||||AUC(0-t). Standard error of mean was on logged scale|||0.61|0.27|
70878908|NCT03045887|141242566|OTHER||Ratio|0.98|STANDARD_ERROR_OF_MEAN|0.243|||TWO_SIDED|90.0|0.65|1.47|||||AUC(0-t).Standard error of mean was on logged scale|||1.47|0.65|
70878909|NCT03045887|141242566|OTHER||Ratio|1.33|STANDARD_ERROR_OF_MEAN|0.161|||TWO_SIDED|90.0|1.01|1.74|||||AUC(0-t).Standard error of mean was on logged scale|||1.74|1.01|
70878910|NCT03045887|141242566|OTHER||Ratio|1.06|STANDARD_ERROR_OF_MEAN|0.255|||TWO_SIDED|90.0|0.69|1.62|||||AUC(0-t).Standard error of mean was on logged scale|||1.62|0.69|
70878911|NCT03045887|141242566|OTHER||Ratio|1.25|STANDARD_ERROR_OF_MEAN|0.161|||TWO_SIDED|90.0|0.95|1.64|||||AUC(0-t).Standard error of mean was on logged scale|||1.64|0.95|
70878912|NCT03045887|141242567|OTHER||Ratio|1.22|STANDARD_ERROR_OF_MEAN|0.098|||TWO_SIDED|90.0|1.01|1.47|||||Treatment ratio of adjusted geometric mean (Day 14/Day 1) for AUC(0-24) is presented|||1.47|1.01|
70878913|NCT03045887|141242568|OTHER||ratio|0.78|STANDARD_ERROR_OF_MEAN|0.145|||TWO_SIDED|90.0|0.61|0.99||||||||0.99|0.61|
70878914|NCT03045887|141242568|OTHER||ratio|0.96|STANDARD_ERROR_OF_MEAN|0.145|||TWO_SIDED|90.0|0.75|1.22||||||||1.22|0.75|
70878915|NCT03045887|141242568|OTHER||ratio|0.81|STANDARD_ERROR_OF_MEAN|0.106|||TWO_SIDED|90.0|0.68|0.97||||||||0.97|0.68|
70878916|NCT03045887|141242568|OTHER||ratio|0.66|STANDARD_ERROR_OF_MEAN|0.154|||TWO_SIDED|90.0|0.51|0.86||||||||0.86|0.51|
70878917|NCT03045887|141242568|OTHER||ratio|0.76|STANDARD_ERROR_OF_MEAN|0.106|||TWO_SIDED|90.0|0.63|0.9||||||||0.90|0.63|
70878918|NCT03045887|141242569|OTHER||ratio|1.14|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|90.0|0.96|1.36|||||Treatment ratio of adjusted geometric mean (Day 14/Day 1) for Cmax is presented|||1.36|0.96|
70878919|NCT03045887|141242575|OTHER||Ratio|2.06|STANDARD_ERROR_OF_MEAN|0.128|||TWO_SIDED|90.0|1.67|2.55|||||Treatment ratio of adjusted geometric mean (Day 14/Day 1) for Ctau is presented.|||2.55|1.67|
70878920|NCT01912287|141242580|SUPERIORITY||Odds Ratio (OR)|2.46||||0.03|TWO_SIDED|95.0|1.12|5.42|||Generalized Linear Mixed Models|||This comparison is from the Generalized Linear Mixed Models (GLMM) analysis using a quadratic growth curve over time. This comparison is at post-treatment. Note, although all 3 groups are included in the GLMM, this statistical test specifically compares response rates of KY vs. SE at post-treatment||5.42|1.12|.03
70958624|NCT03486457|141421367|SUPERIORITY||Difference in percentage of participants|30.15|STANDARD_ERROR_OF_MEAN|5.41|<|0.0001|TWO_SIDED|95.0|19.53|40.76|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||40.76|19.53|<0.0001
70958625|NCT03486457|141421367|SUPERIORITY||Difference in percentage of participants|51.47|STANDARD_ERROR_OF_MEAN|5.56|<|0.0001|TWO_SIDED|95.0|40.57|62.37|||Normal approximation|||Month 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||62.37|40.57|<0.0001
70958626|NCT03486457|141421367|SUPERIORITY||Difference in percentage of participants|36.76|STANDARD_ERROR_OF_MEAN|6.81|<|0.0001|TWO_SIDED|95.0|23.41|50.12|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||50.12|23.41|<0.0001
70958627|NCT03486457|141421367|SUPERIORITY||Difference in percentage of participants|24.26|STANDARD_ERROR_OF_MEAN|7.21||0.0008|TWO_SIDED|95.0|10.14|38.39|||Normal approximation|||Month 4: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||38.39|10.14|0.0008
70958628|NCT03486457|141421367|SUPERIORITY||Difference in percentage of participants|13.97|STANDARD_ERROR_OF_MEAN|7.08||0.0486|TWO_SIDED|95.0|0.09|27.85|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||27.85|0.09|0.0486
70958629|NCT03486457|141421368|SUPERIORITY||Difference in percentage of participants|1.1|STANDARD_ERROR_OF_MEAN|1.53||0.473|TWO_SIDED|95.0|-1.9|4.1|||Normal approximation|||Week 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||4.10|-1.90|0.4730
70958630|NCT03486457|141421368|SUPERIORITY||Difference in percentage of participants|1.83|STANDARD_ERROR_OF_MEAN|1.69||0.2792|TWO_SIDED|95.0|-1.48|5.14|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||5.14|-1.48|0.2792
70958631|NCT03486457|141421368|SUPERIORITY||Difference in percentage of participants|7.35|STANDARD_ERROR_OF_MEAN|2.84||0.0095|TWO_SIDED|95.0|1.79|12.91|||Normal approximation|||Month 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||12.91|1.79|0.0095
70958632|NCT03486457|141421368|SUPERIORITY||Difference in percentage of participants|13.24|STANDARD_ERROR_OF_MEAN|3.37|<|0.0001|TWO_SIDED|95.0|6.63|19.84|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||19.84|6.63|<0.0001
70878921|NCT01912287|141242580|SUPERIORITY||Odds Ratio, log|5.0|||<|0.001|TWO_SIDED|95.0|2.12|11.82|||Generalized Linear Mixed Models|||This comparison is from the Generalized Linear Mixed Models (GLMM) analysis using a quadratic growth curve over time. This comparison is at post-treatment. Note, although all 3 groups are included in the GLMM, this statistical test specifically compares response rates of CBT vs. SE at post-treatment||11.82|2.12|<.001
70878922|NCT01912287|141242580|SUPERIORITY||Odds Ratio (OR)|0.49||||0.07|TWO_SIDED|95.0|0.24|1.03|||Generalized Linear Mixed Models|||This comparison is from the Generalized Linear Mixed Models (GLMM) analysis using a quadratic growth curve over time. This comparison is at post-treatment. Note, although all 3 groups are included in the GLMM, this statistical test specifically compares response rates of KY vs. CBT at post-treatment||1.03|0.24|0.07
70878923|NCT03226392|141242583|SUPERIORITY||Mean Difference (Net)|-0.031||||0.214|TWO_SIDED|95.0|-0.08|0.018|||ANCOVA|||||0.018|-0.080|0.214
70878924|NCT03226392|141242584|SUPERIORITY||Mean Difference (Net)|-0.1||||0.035|TWO_SIDED|0.035|-0.19|0.01|||ANCOVA|||||0.01|-0.19|0.035
70878925|NCT03226392|141242585|SUPERIORITY||Mean Difference (Net)|0.093||||0.893|TWO_SIDED|95.0|-0.2|0.17|||ANCOVA|||||0.17|-0.20|0.893
70878926|NCT03226392|141242586|SUPERIORITY||Mean Difference (Net)|0.061||||0.448|TWO_SIDED|95.0|-0.07|0.17|||ANCOVA|||||0.17|-0.07|0.448
70958633|NCT03486457|141421368|SUPERIORITY||Difference in percentage of participants|13.24|STANDARD_ERROR_OF_MEAN|4.69||0.0048|TWO_SIDED|95.0|4.03|22.44|||Normal approximation|||Month 4: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||22.44|4.03|0.0048
70878927|NCT02357901|141242587|SUPERIORITY||||||<|0.0001||||||significance at the 0.025 level|Wilcoxon rank-sum test|||||||<0.0001
70878928|NCT02357901|141242587|SUPERIORITY||||||<|0.0001||||||significance at the 0.025 level|Wilcoxon rank-sum test|||||||<0.0001
70878929|NCT02357901|141242588|SUPERIORITY||||||<|0.0001||||||Significance level of 0.05.|Cochran-Mantel-Haenszel|||||||<0.0001
70878930|NCT02357901|141242588|SUPERIORITY||||||<|0.0001||||||Significance level of 0.05.|Cochran-Mantel-Haenszel|||||||<0.0001
70878931|NCT02357901|141242589|SUPERIORITY||||||<|0.0001||||||Significance level of 0.05.|Wilcoxon rank-sum test|||||||<0.0001
70878932|NCT02357901|141242589|SUPERIORITY||||||<|0.0001||||||Significance level of 0.05.|Wilcoxon rank-sum test|||||||<0.0001
70878933|NCT02357901|141242590|SUPERIORITY||||||<|0.0001||||||Significance level of 0.05.|Wilcoxon rank-sum test|||||||<0.0001
70878934|NCT02357901|141242590|SUPERIORITY||||||<|0.0001||||||Significance level of 0.05.|Wilcoxon rank-sum test|||||||<0.0001
70878935|NCT02357901|141242591|SUPERIORITY||LSM difference|-9.4|STANDARD_ERROR_OF_MEAN|2.62||0.0003|TWO_SIDED|95.0|-14.56|-4.3||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-4.30|-14.56|0.0003
70878936|NCT02357901|141242591|SUPERIORITY||LSM difference|-12.4|STANDARD_ERROR_OF_MEAN|2.61|<|0.0001|TWO_SIDED|95.0|-17.51|-7.28||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-7.28|-17.51|<0.0001
70878937|NCT02357901|141242592|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|stratified by site||||||<0.0001
70958634|NCT03486457|141421368|SUPERIORITY||Difference in percentage of participants|13.24|STANDARD_ERROR_OF_MEAN|6.6||0.0449|TWO_SIDED|95.0|0.3|26.17|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||26.17|0.30|0.0449
70958635|NCT03486457|141421369|SUPERIORITY||Difference in percentage of participants|2.94|STANDARD_ERROR_OF_MEAN|2.29||0.1985|TWO_SIDED|95.0|-1.54|7.42|||Normal approximation|||Week 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||7.42|-1.54|0.1985
70958636|NCT03486457|141421369|SUPERIORITY||Difference in percentage of participants|8.09|STANDARD_ERROR_OF_MEAN|2.91||0.0055|TWO_SIDED|95.0|2.38|13.8|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||13.80|2.38|0.0055
70878938|NCT02357901|141242592|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|stratified by site||||||<0.0001
70878939|NCT02357901|141242593|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|stratified by site||||||<0.0001
70878940|NCT02357901|141242593|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|stratified by site||||||<0.0001
70878941|NCT02357901|141242594|SUPERIORITY||LSM difference|-0.7|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.96|-0.46||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-0.46|-0.96|<0.0001
70878942|NCT02357901|141242594|SUPERIORITY||LSM difference|-0.9|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.12|-0.62||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-0.62|-1.12|<0.0001
70878943|NCT02357901|141242595|SUPERIORITY||LSM difference|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.89|-0.33||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-0.33|-0.89|<0.0001
70878944|NCT02357901|141242595|SUPERIORITY||LSM difference|-0.7|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.97|-0.41||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-0.41|-0.97|<0.0001
70958637|NCT03486457|141421369|SUPERIORITY||Difference in percentage of participants|27.21|STANDARD_ERROR_OF_MEAN|4.44|<|0.0001|TWO_SIDED|95.0|18.51|35.9|||Normal approximation|||Month 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||35.90|18.51|<0.0001
70958638|NCT03486457|141421369|SUPERIORITY||Difference in percentage of participants|22.06|STANDARD_ERROR_OF_MEAN|6.37||0.0005|TWO_SIDED|95.0|9.58|34.54|||Normal approximation|||Month 4: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||34.54|9.58|0.0005
70958639|NCT03486457|141421369|SUPERIORITY||Difference in percentage of participants|18.38|STANDARD_ERROR_OF_MEAN|7.24||0.0111|TWO_SIDED|95.0|4.2|32.57|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||32.57|4.20|0.0111
70878945|NCT02357901|141242596|SUPERIORITY||LSM difference|-0.4|STANDARD_ERROR_OF_MEAN|0.38||0.3143|TWO_SIDED|95.0|-1.13|0.36||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||0.36|-1.13|0.3143
70958640|NCT03486457|141421370|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.044||0.0097|TWO_SIDED|95.0|-0.2|-0.03|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.03|-0.20|0.0097
70958641|NCT03486457|141421370|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.045||0.0043|TWO_SIDED|95.0|-0.22|-0.04|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.04|-0.22|0.0043
70958642|NCT03486457|141421370|SUPERIORITY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001|TWO_SIDED|95.0|-0.3|-0.11|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.11|-0.30|<0.0001
70958643|NCT03486457|141421370|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.053|<|0.0001|TWO_SIDED|95.0|-0.32|-0.11|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.11|-0.32|<0.0001
70958644|NCT03486457|141421370|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.046||0.0535|TWO_SIDED|95.0|-0.18|0.0|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.00|-0.18|0.0535
70958645|NCT03486457|141421370|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.044||0.094|TWO_SIDED|95.0|-0.16|0.01|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.01|-0.16|0.0940
70958646|NCT03486457|141421371|SUPERIORITY||Difference in percentage of participants|13.07|STANDARD_ERROR_OF_MEAN|8.56||0.127|TWO_SIDED|95.0|-3.72|29.85|||Normal approximation|||Week 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||29.85|-3.72|0.1270
70958647|NCT03486457|141421371|SUPERIORITY||Difference in percentage of participants|4.02|STANDARD_ERROR_OF_MEAN|9.23||0.6634|TWO_SIDED|95.0|-14.07|22.1|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||22.10|-14.07|0.6634
70958648|NCT03486457|141421371|SUPERIORITY||Difference in percentage of participants|21.78|STANDARD_ERROR_OF_MEAN|9.46||0.0214|TWO_SIDED|95.0|3.23|40.33|||Normal approximation|||Month 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||40.33|3.23|0.0214
70878946|NCT02357901|141242596|SUPERIORITY||LSM difference|-1.0|STANDARD_ERROR_OF_MEAN|0.38||0.0101|TWO_SIDED|95.0|-1.72|-0.23||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-0.23|-1.72|0.0101
70878947|NCT02357901|141242597|SUPERIORITY||LSM difference|-1.6|STANDARD_ERROR_OF_MEAN|0.87||0.0726|TWO_SIDED|95.0|-3.29|0.14||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||0.14|-3.29|0.0726
70878948|NCT02357901|141242597|SUPERIORITY||LSM difference|-2.6|STANDARD_ERROR_OF_MEAN|0.87||0.0028|TWO_SIDED|95.0|-4.32|-0.9||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-0.90|-4.32|0.0028
70878949|NCT02357901|141242598|SUPERIORITY||LSM difference|7.5|STANDARD_ERROR_OF_MEAN|0.86|<|0.0001|TWO_SIDED|95.0|5.81|9.2||Significance level of 0.05.|ANOVA|a random effects ANOVA model with treatment included as fixed effect and center as random effect.||||9.20|5.81|<0.0001
70878950|NCT02357901|141242598|SUPERIORITY||LSM difference|7.5|STANDARD_ERROR_OF_MEAN|0.86|<|0.0001|TWO_SIDED|95.0|5.82|9.21||Significance level of 0.05.|ANOVA|a random effects ANOVA model with treatment included as fixed effect and center as random effect.||||9.21|5.82|<0.0001
70878951|NCT01086540|141242613|SUPERIORITY||Median Difference (Final Values)|23.1|STANDARD_ERROR_OF_MEAN|14.71||0.12|TWO_SIDED||||||Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 24.|The null hypothesis was that the mean change in 6MWD between baseline and Week 24 does not differ between rituximab and placebo. A repeated measures random effect model was fit to model the distance walked as a function of treatment, visit week, a treatment by visit week interaction, and a quadratic visit term. A random slope and intercept were fit for each participant using a separate unstructured covariance matrix for each treatment group. The model included all available data up to Week 24.||||0.12
70958649|NCT03486457|141421371|SUPERIORITY||Difference in percentage of participants|24.03|STANDARD_ERROR_OF_MEAN|9.46||0.011|TWO_SIDED|95.0|5.5|42.57|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||42.57|5.50|0.0110
70878952|NCT01086540|141242614|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.71||0.42|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis|||A repeated measures mixed model was fit with PVR as the outcome and treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.42
70878953|NCT01086540|141242615|SUPERIORITY||Mean Difference (Final Values)|16.4|STANDARD_ERROR_OF_MEAN|15.1||0.28|TWO_SIDED|||||Week 48 value. P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 48.|A repeated measures random effect model was fit to model the distance walked as a function of treatment, visit week, a treatment by visit week interaction, and a quadratic visit term. A random slope and intercept were fit for each participant using a separate unstructured covariance matrix for each treatment group. The model included all available data up to Week 48.||||0.28
70878954|NCT01086540|141242615|SUPERIORITY||Mean Difference (Final Values)|25.1|STANDARD_ERROR_OF_MEAN|11.5||0.031|TWO_SIDED|||||Week 24 value. P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 24.|A repeated measures random effect model was fit to model the distance walked as a function of treatment, visit week, a treatment by visit week interaction, and a quadratic visit term. A random slope and intercept were fit for each participant using a separate unstructured covariance matrix for each treatment group. The model included all available data up to Week 48.||||0.031
70878955|NCT01086540|141242616|SUPERIORITY|||||||0.92||||||P-values not adjusted for multiple comparisons.|Log Rank|||Kaplan-Meier curves for time to clinical worsening were compared using a log-rank test.||||0.92
70878956|NCT01086540|141242617|SUPERIORITY|||||||0.36||||||P-values not adjusted for multiple comparisons.|Log Rank|||Kaplan-Meier curves for time to change or addition of PAH medications were compared using a log-rank test.||||0.36
70878957|NCT01086540|141242618|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.7||0.81|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 48.|A repeated measures random effect model was fit with the mental component score as the outcome, and treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.81
70958650|NCT03486457|141421371|SUPERIORITY||Difference in percentage of participants|12.57|STANDARD_ERROR_OF_MEAN|9.58||0.1896|TWO_SIDED|95.0|-6.21|31.36|||Normal approximation|||Month 4: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||31.36|-6.21|0.1896
70958651|NCT03486457|141421371|SUPERIORITY||Difference in percentage of participants|6.83|STANDARD_ERROR_OF_MEAN|8.97||0.4466|TWO_SIDED|95.0|-10.75|24.41|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||24.41|-10.75|0.4466
70958652|NCT03486457|141421372|SUPERIORITY||Difference in percentage of participants|13.07|STANDARD_ERROR_OF_MEAN|8.56||0.127|TWO_SIDED|95.0|-3.72|29.85|||Normal approximation|||Week 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||29.85|-3.72|0.1270
70878958|NCT01086540|141242619|SUPERIORITY||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|2.1||0.3|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 48.|A repeated measures random effect model was fit with the physical component score as the outcome, and treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.30
70878959|NCT01086540|141242620|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.58|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 48.|A repeated measures random effect model was fit with HAQ-DI as the outcome, and treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.58
70878960|NCT01086540|141242621|SUPERIORITY|||||||0.47||||||P-values not adjusted for multiple comparisons.|Regression, Linear|||A Poisson model was used to describe the rate of new digital ulcers (per week) as the outcome with treatment, number of digital ulcers at Baseline, and if the measurement was affected by changed or new PAH therapeutic agents as covariates.||||0.47
70878961|NCT01086540|141242622|SUPERIORITY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|5.7||0.43|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 48.|A repeated measures random effect model was fit with severity of Raynaud's (0 to 100) as the outcome, and treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.43
70878962|NCT01086540|141242623|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|2.8||0.65|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 48.|A repeated measures random effect model was fit with DLCO as the outcome, and treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.65
70958653|NCT03486457|141421372|SUPERIORITY||Difference in percentage of participants|4.02|STANDARD_ERROR_OF_MEAN|9.23||0.6634|TWO_SIDED|95.0|-14.07|22.1|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||22.10|-14.07|0.6634
70878963|NCT01086540|141242625|SUPERIORITY||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|9.7||0.42|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis|||A repeated measures mixed model was fit with percent change in PVR as the outcome and baseline PVR, treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.42
70878964|NCT01086540|141242630|SUPERIORITY|||||||0.17||||||P-values not adjusted for multiple comparisons.|Log Rank|||Kaplan-Meier curves for time to all-cause mortality were compared using a log-rank test.||||0.17
70878965|NCT01086540|141242631|SUPERIORITY|||||||0.35||||||P-values not adjusted for multiple comparisons.|Log Rank|||Kaplan-Meier curves for time to all-cause mortality were compared using a log-rank test.||||0.35
70878966|NCT02278263|141242632|SUPERIORITY||||||<|0.05|||||||ANOVA|||Assuming a common standard deviation of 412 mL, to detect a difference of 300 mL of blood loss between the two treatment arms (sTXA and tTXA) and the placebo group, a sample size of 125 participants is required for a statistical power of 0.85, and a type I error of 0.05. The sample size required was 125 participants in total. The was increased by 15% to allow for expected dropouts. Therefore, a minimum of 147 patients was required for the study.||||<0.05
70878967|NCT03164928|141242639|SUPERIORITY||Least Squares Mean Difference|0.11||||0.68|TWO_SIDED|95.0|-0.45|0.673|||ANCOVA|||||0.673|-0.450|0.68
70878968|NCT03164928|141242640|SUPERIORITY||Least Squares Mean Difference|0.17||||0.34|TWO_SIDED|95.0|-0.194|0.542|||Repeated Measures Model|||Month 6||0.542|-0.194|0.34
70878969|NCT03164928|141242640|SUPERIORITY||Least Squares Mean Difference|0.03||||0.93|TWO_SIDED|95.0|-0.609|0.661|||Repeated Measures Model|||Month 18||0.661|-0.609|0.93
70878970|NCT03164928|141242640|SUPERIORITY||Least Squares Mean Difference|0.11||||0.74|TWO_SIDED|95.0|-0.572|0.795|||Repeated Measures Model|||Month 24||0.795|-0.572|0.74
70958654|NCT03486457|141421372|SUPERIORITY||Difference in percentage of participants|21.78|STANDARD_ERROR_OF_MEAN|9.46||0.0214|TWO_SIDED|95.0|3.23|40.33|||Normal approximation|||Month 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||40.33|3.23|0.0214
70878971|NCT03164928|141242640|SUPERIORITY||Least Squares Means Difference|-0.8||||0.12|TWO_SIDED|95.0|-1.848|0.239|||Repeated Measures Model|||Month 36||0.239|-1.848|0.12
70958655|NCT03486457|141421372|SUPERIORITY||Difference in percentage of participants|24.03|STANDARD_ERROR_OF_MEAN|9.46||0.011|TWO_SIDED|95.0|5.5|42.57|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||42.57|5.50|0.0110
70878972|NCT03164928|141242641|SUPERIORITY||Least Squares Mean Difference|-0.41||||0.19|TWO_SIDED|95.0|-1.05|0.223|||Repeated Measures Model|||Month 6 (Total Hip)||0.223|-1.050|0.19
70878973|NCT03164928|141242641|SUPERIORITY||Least Squares Mean Difference|-0.06||||0.83|TWO_SIDED|95.0|-0.631|0.515|||Repeated Measures Model|||Month 12 (Total Hip)||0.515|-0.631|0.83
70878974|NCT03164928|141242641|SUPERIORITY||Least Squares Mean Difference|-0.27||||0.51|TWO_SIDED|95.0|-1.108|0.565|||Repeated Measures Model|||Month 18 (Total Hip)||0.565|-1.108|0.51
70878975|NCT03164928|141242641|SUPERIORITY||Least Squares Mean Difference|-0.18||||0.69|TWO_SIDED|95.0|-1.098|0.746|||Repeated Measures Model|||Month 24 (Total Hip)||0.746|-1.098|0.69
70878976|NCT03164928|141242641|SUPERIORITY||Least Squares Mean Difference|-0.09||||0.89|TWO_SIDED|95.0|-1.465|1.286|||Repeated Measures Model|||Month 36 (Total Hip)||1.286|-1.465|0.89
70878977|NCT03164928|141242641|SUPERIORITY||Least Squares Mean Difference|-0.18||||0.64|TWO_SIDED|95.0|-0.969|0.614|||Repeated Measures Model|||Month 6 (Femoral Neck)||0.614|-0.969|0.64
70878978|NCT03164928|141242641|SUPERIORITY||Least Squares Mean Difference|0.1||||0.83|TWO_SIDED|95.0|-0.808|1.0|||Repeated Measures Model|||Month 12 (Femoral Neck)||1.000|-0.808|0.83
70878979|NCT03164928|141242641|SUPERIORITY||Least Squares Mean Difference|0.37||||0.48|TWO_SIDED|95.0|-0.697|1.442|||Repeated Measures Model|||Month 18 (Femoral Neck)||1.442|-0.697|0.48
70878980|NCT03164928|141242641|SUPERIORITY||Least Squares Mean Difference|0.11||||0.86|TWO_SIDED|95.0|-1.222|1.443|||Repeated Measures Model|||Month 24 (Femoral Neck)||1.443|-1.222|0.86
70878981|NCT03164928|141242641|SUPERIORITY||Least Squares Mean Difference|0.38||||0.66|TWO_SIDED|95.0|-1.378|2.13|||Repeated Measures Model|||Month 36 (Femoral Neck)||2.130|-1.378|0.66
70878982|NCT01474876|141242681|SUPERIORITY_OR_OTHER|||||||0.0164|TWO_SIDED||||||Regression, Logistic|||Treatment response and participant age||||0.0164
70878983|NCT01474876|141242681|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Regression, Logistic|||Treatment response and presence of enthesitis at Visit 0||||0.0200
70878984|NCT01474876|141242681|SUPERIORITY_OR_OTHER|||||||0.0867|TWO_SIDED||||||Regression, Logistic|||Treatment response and BASDAI score at Visit 0||||0.0867
70958656|NCT03486457|141421372|SUPERIORITY||Difference in percentage of participants|12.57|STANDARD_ERROR_OF_MEAN|9.58||0.1896|TWO_SIDED|95.0|-6.21|31.36|||Normal approximation|||Month 4: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||31.36|-6.21|0.1896
70878985|NCT01474876|141242681|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Regression, Logistic|||Remission and participant age||||0.0001
70878986|NCT01474876|141242681|SUPERIORITY_OR_OTHER|||||||0.0734|TWO_SIDED||||||Regression, Logistic|||Remission and positive tuberculosis screening at Visit 0||||0.0734
70878987|NCT01474876|141242681|SUPERIORITY_OR_OTHER|||||||0.0438|TWO_SIDED||||||Regression, Logistic|||Remission and male gender||||0.0438
70878988|NCT01474876|141242681|SUPERIORITY_OR_OTHER|||||||0.503|TWO_SIDED||||||Regression, Logistic|||Remission and BASDAI score at Visit 0||||0.5030
70878989|NCT01474876|141242690|SUPERIORITY_OR_OTHER|||||||0.0576|TWO_SIDED||||||Regression, Logistic|||Treatment response and presence of enthesitis at Visit 0||||0.0576
70878990|NCT01474876|141242690|SUPERIORITY_OR_OTHER|||||||0.1739|TWO_SIDED||||||Regression, Logistic|||Treatment response and BASDAI score at Visit 0||||0.1739
70878991|NCT01474876|141242690|SUPERIORITY_OR_OTHER|||||||0.0733|TWO_SIDED||||||Regression, Logistic|||Remission and Psoriasis at Visit 0||||0.0733
70878992|NCT01474876|141242690|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Regression, Logistic|||Remission and BASDAI at Visit 0||||0.5000
70878993|NCT04736199|141242715|SUPERIORITY||Hazard Ratio (HR)|0.541|||<|0.0001|TWO_SIDED|95.0|0.413|0.707||One-sided|Log Rank|||Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||0.707|0.413|<0.0001
70958657|NCT03486457|141421372|SUPERIORITY||Difference in percentage of participants|6.83|STANDARD_ERROR_OF_MEAN|8.97||0.4466|TWO_SIDED|95.0|-10.75|24.41|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||24.41|-10.75|0.4466
70878994|NCT04736199|141242716|SUPERIORITY||Hazard Ratio (HR)|0.813||||0.1007|TWO_SIDED|95.0|0.591|1.118||One-sided|Log Rank||significance level of 0.0185 (one-sided)|Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||1.118|0.591|0.1007
70958658|NCT03486457|141421373|SUPERIORITY||LS mean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.633|<|0.0001|TWO_SIDED|95.0|-3.95|-1.45|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.45|-3.95|<0.0001
70878995|NCT04736199|141242717|OTHER||Hazard Ratio (HR)|0.404|||||TWO_SIDED|95.0|0.321|0.508||||||Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||0.508|0.321|
70878996|NCT04736199|141242718|OTHER||Hazard Ratio (HR)|0.401|||||TWO_SIDED|95.0|0.288|0.558||||||Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||0.558|0.288|
70878997|NCT04736199|141242719|OTHER||Hazard Ratio (HR)|0.306|||||TWO_SIDED|95.0|0.231|0.405||||||Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||0.405|0.231|
70878998|NCT04736199|141242720|OTHER||Rate difference|44.3|||||TWO_SIDED|95.0|37.4|51.2||||||Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||51.2|37.4|
70878999|NCT04736199|141242721|OTHER||Hazard Ratio (HR)|0.721|||||TWO_SIDED|95.0|0.544|0.957||||||Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||0.957|0.544|
70879000|NCT04318080|141242723|SUPERIORITY|Analysis tested whether ORR with tislelizumab was superior to a historical ORR of 45% using a one-sided binomial exact test (α = 0.05).|Z-test|2.62||||0.0044|TWO_SIDED|||||One-sided p-value based on a binomial exact test comparing observed ORR to historical rate of 45%.|Binomial Exact Test|||The primary analysis was conducted on both cohorts combined, A binomial exact test was performed to test the null hypothesis (H0: ORR = 45% based on previous clinical trials) and alternative hypothesis (ORR \>45%). If the one-sided p-value was ≤ 0.05, tislelizumab was considered to statistically significantly increase ORR compared to the historical control.||||0.0044
70879001|NCT03914326|141242807|SUPERIORITY|Time from randomisation to first EAC-confirmed MACE was analysed using a Cox proportional hazards model with treatment as categorical fixed factor.|Hazard Ratio (HR)|0.86||||0.0028|TWO_SIDED|95.0|0.77|0.96|||Regression, Cox|||||0.96|0.77|0.0028
70879002|NCT04259762|141242834|OTHER|This is a summary of the total number of participants in the focus groups who endorsed the particular theme.|Proportion endorsing themes|1.0|||||TWO_SIDED|||||||||All focus groups were summarized together and, therefore, the denominators (N=85 \[Community\], N=11 \[Provider\]) for each theme are the same. Further, the focus groups only made qualitative (and no quantitative) assessments/endoresement of themes. No formal comparisons among groups were made.||||
70879003|NCT04259762|141242836|OTHER|Formal statistical comparisons were not made.|Proportion endorsing attempt to screen|0.567|||||TWO_SIDED|95.0|0.303|0.831|||||"Pooled estimate of attempt to screening. Using R:~n1 \<- c(20,28,11,15,26,23,21); nt \<- c(45,50,45,50,50,50,22) p1 \<- n1/nt; v1 \<- p1\*(1-p1)/nt fit \<- lm(p1 \~ 1,weight=1/v1) summary(fit)$coef\[1\] + qt(.975,6)\*c(0,-1,1)\*summary(fit)$coef\[2\]"|||0.831|0.303|
70879004|NCT01203046|141242837|NON_INFERIORITY_OR_EQUIVALENCE|It was used for the calculation of statistical power an author of 5% level, it was felt that the difference between the minimum value of non inferiority does not exceed 10%.|Odds Ratio (OR)|2.65|||<|0.05|TWO_SIDED|95.0|0.35|19.83|||Regression, Logistic|||||19.83|0.35|<0.05
70879005|NCT01203046|141242838|NON_INFERIORITY_OR_EQUIVALENCE|Consider a 5% confidence level, the power of assigned contrast was 80% to detect a difference minima of at least 10% of equivalence between the analyzed groups.|Odds Ratio (OR)|1.18|||<|0.05|TWO_SIDED|95.0|0.21|6.51|||Regression, Logistic|||||6.51|0.21|<0.05
70879006|NCT04788953|141242848|SUPERIORITY||||||<|0.001||||||Change from baseline using mixed-effects tobit regression model (censored normal). Group (Solriamfetol, Placebo), visit (Baseline, End-of-Treatment), trial (1-4) main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||The statistical null hypothesis was that solriamfetol does not improve change in MWT scores versus placebo after 4 weeks of treatment (H0: µsol - µpl ≤ 0). Study was designed to have 97% power to detect a difference of 5.7 minutes or greater on MWT sleep latency (α=0.05, assumed σ=7.2) with 100 participants. Blinded interim power analysis on the baseline data conducted in October 2023 indicated the trial would have \>99% power to detect a similar difference with only 74 participants.||||<0.001
70879007|NCT04788953|141242849|SUPERIORITY||||||<|0.001||||||Change from baseline using mixed-effects linear regression model. Group (Solriamfetol, Placebo), visit (Baseline, End-of-Treatment), trial (1-4) main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||||||<0.001
70879008|NCT04788953|141242850|SUPERIORITY|||||||0.01||||||"Chi-squared tests performed on dichotomized CGI-Change data (Improved \[very much improved, much improved, minimally improved\] vs. Not Improved \[no change, minimally worse, much worse, very much worse\])."|Chi-squared|P-value is difference between groups.||||||0.01
70958659|NCT03486457|141421373|SUPERIORITY||LS mean difference|-3.79|STANDARD_ERROR_OF_MEAN|0.711|<|0.0001|TWO_SIDED|95.0|-5.2|-2.39|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-2.39|-5.20|<0.0001
70958660|NCT03486457|141421373|SUPERIORITY||LS mean difference|-4.89|STANDARD_ERROR_OF_MEAN|0.76|<|0.0001|TWO_SIDED|95.0|-6.39|-3.39|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-3.39|-6.39|<0.0001
70958661|NCT03486457|141421373|SUPERIORITY||LS mean difference|-5.85|STANDARD_ERROR_OF_MEAN|0.852|<|0.0001|TWO_SIDED|95.0|-7.53|-4.17|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-4.17|-7.53|<0.0001
70958662|NCT03486457|141421373|SUPERIORITY||LS mean difference|-3.2|STANDARD_ERROR_OF_MEAN|0.583|<|0.0001|TWO_SIDED|95.0|-4.35|-2.04|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-2.04|-4.35|<0.0001
70879009|NCT04788953|141242852|SUPERIORITY|Change from baseline using mixed-effects linear regression model. Group (Solriamfetol vs. Placebo) and visit (Baseline vs. End-of-Treatment) as main factors and their interactions. Covariates considered: age, sex, ethnicity, race.||||||0.02|||||||Mixed Models Analysis|P-value is difference between groups.||||||0.02
70879010|NCT04788953|141242853|SUPERIORITY|||||||0.64||||||Change from baseline using mixed-effects linear regression model. Group (Solriamfetol vs. Placebo) and visit (Baseline vs. End-of-Treatment) as main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||||||0.64
70879011|NCT04788953|141242854|SUPERIORITY|||||||0.04||||||Change from baseline using mixed-effects linear regression model. Group (Solriamfetol vs. Placebo) and visit (Baseline vs. End-of-Treatment) as main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||||||0.04
70879012|NCT04788953|141242855|SUPERIORITY|||||||0.61||||||Change from baseline using mixed-effects linear regression model. Group (Solriamfetol vs. Placebo) and Condition (Baseline vs. Treatment) as main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||||||0.61
70879013|NCT04788953|141242856|SUPERIORITY|||||||0.57||||||Change from baseline using mixed-effects linear regression model. Group (Solriamfetol vs. Placebo) and Condition (Baseline vs. Treatment) as main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||||||0.57
70879014|NCT04788953|141242857|SUPERIORITY||||||<|0.001||||||Change from baseline using mixed-effects linear regression model. Group (Solriamfetol vs. Placebo) and visit (Baseline vs. End-of-Treatment) as main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||||||<0.001
70958663|NCT03486457|141421373|SUPERIORITY||LS mean difference|-2.59|STANDARD_ERROR_OF_MEAN|0.668||0.0002|TWO_SIDED|95.0|-3.91|-1.27|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.27|-3.91|0.0002
70958664|NCT03486457|141421374|SUPERIORITY||LS mean difference|-3.4|STANDARD_ERROR_OF_MEAN|1.012||0.001|TWO_SIDED|95.0|-5.4|-1.4|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.40|-5.40|0.0010
70958665|NCT03486457|141421374|SUPERIORITY||LS mean difference|-5.03|STANDARD_ERROR_OF_MEAN|1.024|<|0.0001|TWO_SIDED|95.0|-7.05|-3.01|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-3.01|-7.05|<0.0001
70958666|NCT03486457|141421374|SUPERIORITY||LS mean difference|-5.68|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|95.0|-7.7|-3.66|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-3.66|-7.70|<0.0001
70958667|NCT03486457|141421374|SUPERIORITY||LS mean difference|-7.01|STANDARD_ERROR_OF_MEAN|1.111|<|0.0001|TWO_SIDED|95.0|-9.2|-4.82|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-4.82|-9.20|<0.0001
70958668|NCT03486457|141421374|SUPERIORITY||LS mean difference|-3.95|STANDARD_ERROR_OF_MEAN|1.073||0.0003|TWO_SIDED|95.0|-6.07|-1.83|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.83|-6.07|0.0003
70958669|NCT03486457|141421374|SUPERIORITY||LS mean difference|-2.39|STANDARD_ERROR_OF_MEAN|1.108||0.0323|TWO_SIDED|95.0|-4.58|-0.2|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.20|-4.58|0.0323
70958670|NCT03486457|141421375|SUPERIORITY||LS mean difference|-6.57|STANDARD_ERROR_OF_MEAN|2.481||0.0087|TWO_SIDED|95.0|-11.46|-1.68|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.68|-11.46|0.0087
70958671|NCT03486457|141421375|SUPERIORITY||LS mean difference|-11.7|STANDARD_ERROR_OF_MEAN|2.487|<|0.0001|TWO_SIDED|95.0|-16.6|-6.79|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-6.79|-16.60|<0.0001
70958672|NCT03486457|141421375|SUPERIORITY||LS mean difference|-16.14|STANDARD_ERROR_OF_MEAN|2.796|<|0.0001|TWO_SIDED|95.0|-21.66|-10.63|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-10.63|-21.66|<0.0001
70958673|NCT03486457|141421375|SUPERIORITY||LS mean difference|-21.87|STANDARD_ERROR_OF_MEAN|3.027|<|0.0001|TWO_SIDED|95.0|-27.84|-15.9|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-15.90|-27.84|<0.0001
70958674|NCT03486457|141421375|SUPERIORITY||LS mean difference|-6.94|STANDARD_ERROR_OF_MEAN|2.865||0.0163|TWO_SIDED|95.0|-12.6|-1.29|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.29|-12.60|0.0163
70958675|NCT03486457|141421375|SUPERIORITY||LS mean difference|-3.1|STANDARD_ERROR_OF_MEAN|2.967||0.2977|TWO_SIDED|95.0|-8.95|2.76|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||2.76|-8.95|0.2977
70958676|NCT03486457|141421376|SUPERIORITY||LS mean difference|-6.15|STANDARD_ERROR_OF_MEAN|2.646||0.0211|TWO_SIDED|95.0|-11.37|-0.93|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.93|-11.37|0.0211
70958677|NCT03486457|141421376|SUPERIORITY||LS mean difference|-13.08|STANDARD_ERROR_OF_MEAN|2.79|<|0.0001|TWO_SIDED|95.0|-18.59|-7.58|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-7.58|-18.59|<0.0001
70958678|NCT03486457|141421376|SUPERIORITY||LS mean difference|-13.16|STANDARD_ERROR_OF_MEAN|2.928|<|0.0001|TWO_SIDED|95.0|-18.93|-7.38|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-7.38|-18.93|<0.0001
70958679|NCT03486457|141421376|SUPERIORITY||LS mean difference|-18.77|STANDARD_ERROR_OF_MEAN|3.187|<|0.0001|TWO_SIDED|95.0|-25.06|-12.49|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-12.49|-25.06|<0.0001
70958680|NCT03486457|141421376|SUPERIORITY||LS mean difference|-7.01|STANDARD_ERROR_OF_MEAN|2.827||0.014|TWO_SIDED|95.0|-12.59|-1.43|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.43|-12.59|0.0140
70958681|NCT03486457|141421376|SUPERIORITY||LS mean difference|-5.14|STANDARD_ERROR_OF_MEAN|2.931||0.0811|TWO_SIDED|95.0|-10.93|0.64|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.64|-10.93|0.0811
70958682|NCT03486457|141421377|SUPERIORITY||LS mean difference|-9.64|STANDARD_ERROR_OF_MEAN|1.939|<|0.0001|TWO_SIDED|95.0|-13.46|-5.81|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-5.81|-13.46|<0.0001
70958683|NCT03486457|141421377|SUPERIORITY||LS mean difference|-9.52|STANDARD_ERROR_OF_MEAN|2.305|<|0.0001|TWO_SIDED|95.0|-14.07|-4.98|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-4.98|-14.07|<0.0001
70958684|NCT03486457|141421377|SUPERIORITY||LS mean difference|-16.97|STANDARD_ERROR_OF_MEAN|2.472|<|0.0001|TWO_SIDED|95.0|-21.85|-12.1|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-12.10|-21.85|<0.0001
70879015|NCT02293655|141242858|SUPERIORITY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|2.6||0.55|TWO_SIDED||||||t-test, 2 sided|||Compared at Baseline Time point||||0.55
70958685|NCT03486457|141421377|SUPERIORITY||LS mean difference|-18.42|STANDARD_ERROR_OF_MEAN|2.506|<|0.0001|TWO_SIDED|95.0|-23.36|-13.48|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-13.48|-23.36|<0.0001
70958686|NCT03486457|141421377|SUPERIORITY||LS mean difference|-7.22|STANDARD_ERROR_OF_MEAN|2.453||0.0037|TWO_SIDED|95.0|-12.06|-2.38|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-2.38|-12.06|0.0037
70958687|NCT03486457|141421377|SUPERIORITY||LS mean difference|-7.66|STANDARD_ERROR_OF_MEAN|2.267||0.0009|TWO_SIDED|95.0|-12.13|-3.18|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-3.18|-12.13|0.0009
70958688|NCT03486457|141421378|SUPERIORITY||LS mean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.108|<|0.0001|TWO_SIDED|95.0|-9.39|-5.02|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-5.02|-9.39|<0.0001
70958689|NCT03486457|141421378|SUPERIORITY||LS mean difference|-7.87|STANDARD_ERROR_OF_MEAN|1.171|<|0.0001|TWO_SIDED|95.0|-10.18|-5.56|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-5.56|-10.18|<0.0001
70958690|NCT03486457|141421378|SUPERIORITY||LS mean difference|-7.41|STANDARD_ERROR_OF_MEAN|1.182|<|0.0001|TWO_SIDED|95.0|-9.74|-5.08|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-5.08|-9.74|<0.0001
70958691|NCT03486457|141421378|SUPERIORITY||LS mean difference|-7.8|STANDARD_ERROR_OF_MEAN|1.221|<|0.0001|TWO_SIDED|95.0|-10.21|-5.39|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-5.39|-10.21|<0.0001
70958692|NCT03486457|141421378|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.615||0.6264|TWO_SIDED|95.0|-0.91|1.51|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||1.51|-0.91|0.6264
70958693|NCT03486457|141421378|SUPERIORITY||LS mean difference|-1.29|STANDARD_ERROR_OF_MEAN|0.778||0.1008|TWO_SIDED|95.0|-2.82|0.25|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.25|-2.82|0.1008
70958694|NCT03486457|141421379|SUPERIORITY||Difference in percentage of participants|0.44|STANDARD_ERROR_OF_MEAN|1.77||0.8032|TWO_SIDED|95.0|-3.02|3.9|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||3.90|-3.02|0.8032
70958695|NCT03486457|141421379|SUPERIORITY||Difference in percentage of participants|7.47|STANDARD_ERROR_OF_MEAN|3.44||0.0298|TWO_SIDED|95.0|0.73|14.21|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||14.21|0.73|0.0298
70958696|NCT03486457|141421379|SUPERIORITY||Difference in percentage of participants|-11.19|STANDARD_ERROR_OF_MEAN|6.48||0.084|TWO_SIDED|95.0|-23.88|1.5|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||1.50|-23.88|0.0840
70958697|NCT03486457|141421380|SUPERIORITY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.111||0.002|TWO_SIDED|95.0|-0.57|-0.13|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.13|-0.57|0.0020
70958698|NCT03486457|141421380|SUPERIORITY||LS mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.87|-0.32|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.32|-0.87|<0.0001
70958699|NCT03486457|141421380|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.156||0.9678|TWO_SIDED|95.0|-0.3|0.31|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.31|-0.30|0.9678
70958700|NCT03486457|141421381|SUPERIORITY||Difference in percentage of participants|14.96|STANDARD_ERROR_OF_MEAN|5.78||0.0097|TWO_SIDED|95.0|3.63|26.3|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||26.30|3.63|0.0097
70958701|NCT03486457|141421381|SUPERIORITY||Difference in percentage of participants|24.89|STANDARD_ERROR_OF_MEAN|8.2||0.0024|TWO_SIDED|95.0|8.81|40.97|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||40.97|8.81|0.0024
70958702|NCT03486457|141421381|SUPERIORITY||Difference in percentage of participants|-17.93|STANDARD_ERROR_OF_MEAN|11.03||0.1042|TWO_SIDED|95.0|-39.55|3.7|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||3.70|-39.55|0.1042
70879016|NCT02293655|141242858|SUPERIORITY||Mean Difference (Final Values)|2.41|STANDARD_ERROR_OF_MEAN|2.3||0.3|TWO_SIDED||||||t-test, 2 sided|||Comparison at MPH Maintenance Visit (Week 8)||||.30
70958703|NCT03486457|141421382|SUPERIORITY||LS mean difference|-25.89|STANDARD_ERROR_OF_MEAN|7.858||0.0014|TWO_SIDED|95.0|-41.49|-10.29|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-10.29|-41.49|0.0014
70879017|NCT02293655|141242858|SUPERIORITY||Mean Difference (Final Values)|4.01|STANDARD_ERROR_OF_MEAN|3.9||0.28|TWO_SIDED||||||t-test, 2 sided|||Comparison at Randomization Phase 1 (Week 9)||||.28
70879018|NCT02293655|141242858|SUPERIORITY||Mean Difference (Final Values)|9.64|STANDARD_ERROR_OF_MEAN|2.5||0|TWO_SIDED||||||t-test, 2 sided|||Comparison at Randomization Phase 2 (Week 10)||||.00
70879019|NCT02293655|141242858|SUPERIORITY||Mean Difference (Final Values)|7.96|STANDARD_ERROR_OF_MEAN|3.2||0.01|TWO_SIDED||||||t-test, 2 sided|||Comparison at Randomization Phase 3 (Week 12)||||.01
70958704|NCT03486457|141421382|SUPERIORITY||LS mean difference|-34.91|STANDARD_ERROR_OF_MEAN|8.948||0.0002|TWO_SIDED|95.0|-52.69|-17.13|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-17.13|-52.69|0.0002
70958705|NCT03486457|141421382|SUPERIORITY||LS mean difference|5.31|STANDARD_ERROR_OF_MEAN|10.663||0.62|TWO_SIDED|95.0|-15.9|26.51|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||26.51|-15.90|0.6200
70958706|NCT03486457|141421383|SUPERIORITY||LS mean difference|-39.65|STANDARD_ERROR_OF_MEAN|10.862||0.0004|TWO_SIDED|95.0|-61.21|-18.08|||Mixed Models Analysis|||Month 1, Erythema: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-18.08|-61.21|0.0004
70879020|NCT02293655|141242859|SUPERIORITY||Mean Difference (Final Values)|36.04|STANDARD_ERROR_OF_MEAN|25.4||0.32|TWO_SIDED||||||t-test, 2 sided|||Compared at baseline timepoint||||.32
70879021|NCT02293655|141242859|SUPERIORITY||Mean Difference (Final Values)|4.38|STANDARD_ERROR_OF_MEAN|30.1||0.9|TWO_SIDED||||||t-test, 2 sided|||Compared at Maintenance Time Point (week 8)||||.90
70879022|NCT02293655|141242859|SUPERIORITY||Mean Difference (Final Values)|100.81|STANDARD_ERROR_OF_MEAN|37.5||0.007|TWO_SIDED||||||t-test, 2 sided|||Compared at Randomization Phase 1 (week 9)||||.007
70879023|NCT02293655|141242859|SUPERIORITY||Mean Difference (Final Values)|49.07|STANDARD_ERROR_OF_MEAN|56.6||0.26|TWO_SIDED||||||t-test, 2 sided|||Compared at Randomization Phase 2 (week 10)||||.26
70879024|NCT02293655|141242859|SUPERIORITY||Mean Difference (Final Values)|123.9|STANDARD_ERROR_OF_MEAN|37.6||0.01|TWO_SIDED||||||t-test, 2 sided|||Compared at Randomization Phase 3 (week 12)||||.01
70879025|NCT02293655|141242860|SUPERIORITY||Mean Difference (Final Values)|31.13|STANDARD_ERROR_OF_MEAN|32.9||0.33|TWO_SIDED||||||t-test, 2 sided|||Comparison at Baseline||||.33
70879026|NCT02293655|141242860|SUPERIORITY||Mean Difference (Final Values)|56.86|STANDARD_ERROR_OF_MEAN|29.5||0.06|TWO_SIDED||||||t-test, 2 sided|||Comparison at Maintenance (week 8)||||.06
70879027|NCT02293655|141242860|SUPERIORITY||Mean Difference (Final Values)|108.78|STANDARD_ERROR_OF_MEAN|46.8||0.05|TWO_SIDED||||||t-test, 2 sided|||Comparison at Randomization Phase 1 (week 9)||||.05
70879028|NCT02293655|141242860|SUPERIORITY||Mean Difference (Final Values)|118.12|STANDARD_ERROR_OF_MEAN|44.2||0.008|TWO_SIDED||||||t-test, 2 sided|||Comparison at Randomization Phase 2 (week 10)||||.008
70958707|NCT03486457|141421383|SUPERIORITY||LS mean difference|-25.18|STANDARD_ERROR_OF_MEAN|8.453||0.0037|TWO_SIDED|95.0|-41.97|-8.4|||Mixed Models Analysis|||Month 1, Induration: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-8.40|-41.97|0.0037
70958708|NCT03486457|141421383|SUPERIORITY||LS mean difference|-21.3|STANDARD_ERROR_OF_MEAN|10.423||0.0438|TWO_SIDED|95.0|-42.0|-0.61|||Mixed Models Analysis|||Month 1, Scaling: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.61|-42.00|0.0438
70958709|NCT03486457|141421383|SUPERIORITY||LS mean difference|-49.11|STANDARD_ERROR_OF_MEAN|10.529|<|0.0001|TWO_SIDED|95.0|-70.03|-28.19|||Mixed Models Analysis|||Month 3, Erythema: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-28.19|-70.03|<0.0001
70958710|NCT03486457|141421383|SUPERIORITY||LS mean difference|-29.71|STANDARD_ERROR_OF_MEAN|9.47||0.0023|TWO_SIDED|95.0|-48.52|-10.89|||Mixed Models Analysis|||Month 3, Induration: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-10.89|-48.52|0.0023
70958711|NCT03486457|141421383|SUPERIORITY||LS mean difference|-36.78|STANDARD_ERROR_OF_MEAN|10.72||0.0009|TWO_SIDED|95.0|-58.08|-15.49|||Mixed Models Analysis|||Month 3, Scaling: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-15.49|-58.08|0.0009
70879029|NCT02293655|141242860|SUPERIORITY||Mean Difference (Final Values)|77.09|STANDARD_ERROR_OF_MEAN|42.9||0.07|TWO_SIDED||||||t-test, 2 sided|||Comparison at Randomization Phase 3 (week 12)||||.07
70958712|NCT03486457|141421383|SUPERIORITY||LS mean difference|7.03|STANDARD_ERROR_OF_MEAN|10.495||0.5048|TWO_SIDED|95.0|-13.84|27.9|||Mixed Models Analysis|||Month 6, Erythema: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||27.90|-13.84|0.5048
70958713|NCT03486457|141421383|SUPERIORITY||LS mean difference|9.16|STANDARD_ERROR_OF_MEAN|12.273||0.4575|TWO_SIDED|95.0|-15.24|33.57|||Mixed Models Analysis|||Month 6, Induration: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||33.57|-15.24|0.4575
70958714|NCT03486457|141421383|SUPERIORITY||LS mean difference|0.69|STANDARD_ERROR_OF_MEAN|11.539||0.9523|TWO_SIDED|95.0|-22.26|23.65|||Mixed Models Analysis|||Month 6, Scaling: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||23.65|-22.26|0.9523
70958715|NCT03486457|141421384|SUPERIORITY||LS mean difference|-28.69|STANDARD_ERROR_OF_MEAN|8.386||0.0008|TWO_SIDED|95.0|-45.24|-12.15|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-12.15|-45.24|0.0008
70958716|NCT03486457|141421384|SUPERIORITY||LS mean difference|-46.47|STANDARD_ERROR_OF_MEAN|10.632|<|0.0001|TWO_SIDED|95.0|-67.45|-25.49|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-25.49|-67.45|<0.0001
70958717|NCT03486457|141421384|SUPERIORITY||LS mean difference|-26.76|STANDARD_ERROR_OF_MEAN|10.778||0.0141|TWO_SIDED|95.0|-48.05|-5.47|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-5.47|-48.05|0.0141
70958718|NCT03486457|141421385|SUPERIORITY||LS mean difference|-10.75|STANDARD_ERROR_OF_MEAN|2.399|<|0.0001|TWO_SIDED|95.0|-15.48|-6.02|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-6.02|-15.48|<0.0001
70958719|NCT03486457|141421385|SUPERIORITY||LS mean difference|-19.45|STANDARD_ERROR_OF_MEAN|2.575|<|0.0001|TWO_SIDED|95.0|-24.52|-14.37|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-14.37|-24.52|<0.0001
70958720|NCT03486457|141421385|SUPERIORITY||LS mean difference|-6.7|STANDARD_ERROR_OF_MEAN|2.289||0.0039|TWO_SIDED|95.0|-11.22|-2.18|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-2.18|-11.22|0.0039
70958721|NCT03486457|141421386|SUPERIORITY||Difference in percentage of participants|14.19|STANDARD_ERROR_OF_MEAN|5.89||0.016|TWO_SIDED|95.0|2.64|25.73|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||25.73|2.64|0.0160
70958722|NCT03486457|141421386|SUPERIORITY||Difference in percentage of participants|25.65|STANDARD_ERROR_OF_MEAN|8.06||0.0015|TWO_SIDED|95.0|9.86|41.44|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||41.44|9.86|0.0015
70958723|NCT03486457|141421386|SUPERIORITY||Difference in percentage of participants|23.05|STANDARD_ERROR_OF_MEAN|9.16||0.0118|TWO_SIDED|95.0|5.11|41.0|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||41.00|5.11|0.0118
70958724|NCT03486457|141421387|SUPERIORITY||LS mean difference|-3.09|STANDARD_ERROR_OF_MEAN|1.259||0.0156|TWO_SIDED|95.0|-5.58|-0.6|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.60|-5.58|0.0156
70958725|NCT03486457|141421387|SUPERIORITY||LS mean difference|-4.06|STANDARD_ERROR_OF_MEAN|0.989|<|0.0001|TWO_SIDED|95.0|-6.02|-2.1|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-2.10|-6.02|<0.0001
70879030|NCT03814746|141242884|SUPERIORITY||Rate ratio|1.08|||>|0.999|TWO_SIDED|95.0|0.76|1.55|||negative binomial regression model|||||1.55|0.76|> 0.999
70958726|NCT03486457|141421387|SUPERIORITY||LS mean difference|-0.97|STANDARD_ERROR_OF_MEAN|0.346||0.0061|TWO_SIDED|95.0|-1.65|-0.28|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.28|-1.65|0.0061
70958727|NCT03486457|141421388|SUPERIORITY||Difference in percentage of participants|13.03|STANDARD_ERROR_OF_MEAN|10.01||0.193|TWO_SIDED|95.0|-6.59|32.64|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||32.64|-6.59|0.1930
70958728|NCT03486457|141421388|SUPERIORITY||Difference in percentage of participants|24.3|STANDARD_ERROR_OF_MEAN|10.11||0.0162|TWO_SIDED|95.0|4.48|44.11|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||44.11|4.48|0.0162
70958729|NCT03486457|141421388|SUPERIORITY||Difference in percentage of participants|4.07|STANDARD_ERROR_OF_MEAN|10.83||0.7068|TWO_SIDED|95.0|-17.15|25.3|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||25.30|-17.15|0.7068
70958730|NCT03486457|141421389|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.271||0.2811|TWO_SIDED|95.0|-0.83|0.25|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.25|-0.83|0.2811
70958731|NCT03486457|141421389|SUPERIORITY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.295||0.214|TWO_SIDED|95.0|-0.96|0.22|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.22|-0.96|0.2140
70958732|NCT03486457|141421389|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.239||0.2817|TWO_SIDED|95.0|-0.74|0.22|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.22|-0.74|0.2817
70879031|NCT03814746|141242884|SUPERIORITY||Rate ratio|0.89|||>|0.999|TWO_SIDED|95.0|0.62|1.27|||negative binomial regression model|||||1.27|0.62|> 0.999
70879032|NCT03814746|141242885|SUPERIORITY||Rate ratio|1.21|||||TWO_SIDED|95.0|0.87|1.7|||negative binomial regression model|||||1.70|0.87|
70879033|NCT03814746|141242885|SUPERIORITY||Rate ratio|0.83|||||TWO_SIDED|95.0|0.59|1.17|||negative binomial regression model|||||1.17|0.59|
70958733|NCT03486457|141421390|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.182||0.9407|TWO_SIDED|95.0|-0.37|0.35|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.35|-0.37|0.9407
70958734|NCT03486457|141421390|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.293||0.4295|TWO_SIDED|95.0|-0.81|0.35|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.35|-0.81|0.4295
70958735|NCT03486457|141421390|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.314||0.2946|TWO_SIDED|95.0|-0.95|0.29|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.29|-0.95|0.2946
70958736|NCT03486457|141421391|SUPERIORITY||Difference in percentage of participants|21.32|STANDARD_ERROR_OF_MEAN|5.62||0.0001|TWO_SIDED|95.0|10.32|32.33|||Normal approximation|||Week 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||32.33|10.32|0.0001
70958737|NCT03486457|141421391|SUPERIORITY||Difference in percentage of participants|36.03|STANDARD_ERROR_OF_MEAN|6.49|<|0.0001|TWO_SIDED|95.0|23.31|48.75|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||48.75|23.31|<0.0001
70958738|NCT03486457|141421391|SUPERIORITY||Difference in percentage of participants|52.21|STANDARD_ERROR_OF_MEAN|5.79|<|0.0001|TWO_SIDED|95.0|40.86|63.55|||Normal approximation|||Month 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||63.55|40.86|<0.0001
70879034|NCT03814746|141242890|SUPERIORITY||Hazard Ratio (HR)|1.34|||||TWO_SIDED|95.0|0.92|1.97|||Cox Model|for time to first occurrence of VOC||||1.97|0.92|
70958739|NCT03486457|141421391|SUPERIORITY||Difference in percentage of participants|39.71|STANDARD_ERROR_OF_MEAN|6.8|<|0.0001|TWO_SIDED|95.0|26.38|53.03|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||53.03|26.38|<0.0001
70958740|NCT03486457|141421391|SUPERIORITY||Difference in percentage of participants|18.38|STANDARD_ERROR_OF_MEAN|7.23||0.011|TWO_SIDED|95.0|4.22|32.55|||Normal approximation|||Month 4: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||32.55|4.22|0.0110
70958741|NCT03486457|141421391|SUPERIORITY||Difference in percentage of participants|16.18|STANDARD_ERROR_OF_MEAN|6.8||0.0173|TWO_SIDED|95.0|2.85|29.5|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||29.50|2.85|0.0173
70958742|NCT03486457|141421392|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.79|-0.47|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.47|-0.79|<0.0001
70958743|NCT03486457|141421392|SUPERIORITY||LS mean difference|-0.81|STANDARD_ERROR_OF_MEAN|0.095|<|0.0001|TWO_SIDED|95.0|-0.99|-0.62|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.62|-0.99|<0.0001
70958744|NCT03486457|141421392|SUPERIORITY||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.105|<|0.0001|TWO_SIDED|95.0|-1.08|-0.66|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.66|-1.08|<0.0001
70958745|NCT03486457|141421392|SUPERIORITY||LS mean difference|-1.04|STANDARD_ERROR_OF_MEAN|0.122|<|0.0001|TWO_SIDED|95.0|-1.28|-0.8|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.80|-1.28|<0.0001
70958746|NCT03486457|141421392|SUPERIORITY||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.129||0.0009|TWO_SIDED|95.0|-0.69|-0.18|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.18|-0.69|0.0009
70958747|NCT03486457|141421392|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.145||0.1202|TWO_SIDED|95.0|-0.51|0.06|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.06|-0.51|0.1202
70958748|NCT03486457|141421393|SUPERIORITY||LS mean difference|3.72|STANDARD_ERROR_OF_MEAN|0.998||0.0003|TWO_SIDED|95.0|1.76|5.69|||Mixed Models Analysis|||Month 1, Physical Functioning Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.69|1.76|0.0003
70958749|NCT03486457|141421393|SUPERIORITY||LS mean difference|3.18|STANDARD_ERROR_OF_MEAN|1.102||0.0043|TWO_SIDED|95.0|1.01|5.35|||Mixed Models Analysis|||Month 1, Role - Physical Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.35|1.01|0.0043
70958750|NCT03486457|141421393|SUPERIORITY||LS mean difference|3.12|STANDARD_ERROR_OF_MEAN|0.861||0.0004|TWO_SIDED|95.0|1.42|4.82|||Mixed Models Analysis|||Month 1, Bodily Pain Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.82|1.42|0.0004
70958751|NCT03486457|141421393|SUPERIORITY||LS mean difference|3.54|STANDARD_ERROR_OF_MEAN|0.938||0.0002|TWO_SIDED|95.0|1.69|5.39|||Mixed Models Analysis|||Month 1, General Health Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.39|1.69|0.0002
70958752|NCT03486457|141421393|SUPERIORITY||LS mean difference|3.04|STANDARD_ERROR_OF_MEAN|1.203||0.0123|TWO_SIDED|95.0|0.67|5.41|||Mixed Models Analysis|||Month 1, Vitality Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.41|0.67|0.0123
70958753|NCT03486457|141421393|SUPERIORITY||LS mean difference|2.58|STANDARD_ERROR_OF_MEAN|1.115||0.0216|TWO_SIDED|95.0|0.38|4.78|||Mixed Models Analysis|||Month 1, Social Function Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.78|0.38|0.0216
70958754|NCT03486457|141421393|SUPERIORITY||LS mean difference|2.04|STANDARD_ERROR_OF_MEAN|1.336||0.129|TWO_SIDED|95.0|-0.6|4.67|||Mixed Models Analysis|||Month 1, Role - Emotional Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.67|-0.60|0.1290
70958755|NCT03486457|141421393|SUPERIORITY||LS mean difference|1.91|STANDARD_ERROR_OF_MEAN|1.172||0.1043|TWO_SIDED|95.0|-0.4|4.22|||Mixed Models Analysis|||Month 1, Mental Health Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.22|-0.40|0.1043
70958756|NCT03486457|141421393|SUPERIORITY||LS mean difference|3.77|STANDARD_ERROR_OF_MEAN|0.763|<|0.0001|TWO_SIDED|95.0|2.26|5.27|||Mixed Models Analysis|||Month 1, Physical Component Summary: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.27|2.26|<0.0001
70958757|NCT03486457|141421393|SUPERIORITY||LS mean difference|1.78|STANDARD_ERROR_OF_MEAN|1.178||0.1318|TWO_SIDED|95.0|-0.54|4.1|||Mixed Models Analysis|||Month 1, Mental Component Summary: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.10|-0.54|0.1318
70958758|NCT03486457|141421393|SUPERIORITY||LS mean difference|2.53|STANDARD_ERROR_OF_MEAN|1.225||0.0402|TWO_SIDED|95.0|0.11|4.95|||Mixed Models Analysis|||Month 3, Physical Functioning Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.95|0.11|0.0402
70958759|NCT03486457|141421393|SUPERIORITY||LS mean difference|4.41|STANDARD_ERROR_OF_MEAN|1.227||0.0004|TWO_SIDED|95.0|1.99|6.83|||Mixed Models Analysis|||Month 3, Role - Physical Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||6.83|1.99|0.0004
70958760|NCT03486457|141421393|SUPERIORITY||LS mean difference|5.29|STANDARD_ERROR_OF_MEAN|1.069|<|0.0001|TWO_SIDED|95.0|3.18|7.4|||Mixed Models Analysis|||Month 3, Bodily Pain Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||7.40|3.18|<0.0001
70958761|NCT03486457|141421393|SUPERIORITY||LS mean difference|5.28|STANDARD_ERROR_OF_MEAN|1.261|<|0.0001|TWO_SIDED|95.0|2.79|7.76|||Mixed Models Analysis|||Month 3, General Health Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||7.76|2.79|<0.0001
70958762|NCT03486457|141421393|SUPERIORITY||LS mean difference|2.1|STANDARD_ERROR_OF_MEAN|1.366||0.1254|TWO_SIDED|95.0|-0.59|4.8|||Mixed Models Analysis|||Month 3, Vitality Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.80|-0.59|0.1254
70958763|NCT03486457|141421393|SUPERIORITY||LS mean difference|4.34|STANDARD_ERROR_OF_MEAN|1.186||0.0003|TWO_SIDED|95.0|2.0|6.68|||Mixed Models Analysis|||Month 3, Social Function Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||6.68|2.00|0.0003
70958764|NCT03486457|141421393|SUPERIORITY||LS mean difference|3.43|STANDARD_ERROR_OF_MEAN|1.384||0.014|TWO_SIDED|95.0|0.7|6.16|||Mixed Models Analysis|||Month 3, Role - Emotional Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||6.16|0.70|0.0140
70958765|NCT03486457|141421393|SUPERIORITY||LS mean difference|3.47|STANDARD_ERROR_OF_MEAN|1.268||0.0067|TWO_SIDED|95.0|0.97|5.98|||Mixed Models Analysis|||Month 3, Mental Health Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.98|0.97|0.0067
70958766|NCT03486457|141421393|SUPERIORITY||LS mean difference|4.17|STANDARD_ERROR_OF_MEAN|0.986|<|0.0001|TWO_SIDED|95.0|2.23|6.12|||Mixed Models Analysis|||Month 3, Physical Component Summary: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||6.12|2.23|<0.0001
70958767|NCT03486457|141421393|SUPERIORITY||LS mean difference|3.27|STANDARD_ERROR_OF_MEAN|1.248||0.0094|TWO_SIDED|95.0|0.81|5.73|||Mixed Models Analysis|||Month 3, Mental Component Summary: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.73|0.81|0.0094
70958768|NCT03486457|141421393|SUPERIORITY||LS mean difference|0.39|STANDARD_ERROR_OF_MEAN|1.049||0.7098|TWO_SIDED|95.0|-1.68|2.46|||Mixed Models Analysis|||Month 6, Physical Functioning Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||2.46|-1.68|0.7098
70958769|NCT03486457|141421393|SUPERIORITY||LS mean difference|1.04|STANDARD_ERROR_OF_MEAN|1.234||0.4019|TWO_SIDED|95.0|-1.4|3.47|||Mixed Models Analysis|||Month 6, Role - Physical Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||3.47|-1.40|0.4019
70958770|NCT03486457|141421393|SUPERIORITY||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|1.186||0.7537|TWO_SIDED|95.0|-1.97|2.71|||Mixed Models Analysis|||Month 6, Bodily Pain Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||2.71|-1.97|0.7537
70958771|NCT03486457|141421393|SUPERIORITY||LS mean difference|1.22|STANDARD_ERROR_OF_MEAN|1.33||0.3595|TWO_SIDED|95.0|-1.4|3.85|||Mixed Models Analysis|||Month 6, General Health Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||3.85|-1.40|0.3595
70879035|NCT03814746|141242890|SUPERIORITY||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.72|1.58|||Cox Model|for time to first occurrence of VOC||||1.58|0.72|
70958772|NCT03486457|141421393|SUPERIORITY||LS mean difference|1.99|STANDARD_ERROR_OF_MEAN|1.52||0.1919|TWO_SIDED|95.0|-1.01|4.99|||Mixed Models Analysis|||Month 6, Vitality Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.99|-1.01|0.1919
70958773|NCT03486457|141421393|SUPERIORITY||LS mean difference|0.28|STANDARD_ERROR_OF_MEAN|1.209||0.8163|TWO_SIDED|95.0|-2.1|2.67|||Mixed Models Analysis|||Month 6, Social Function Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||2.67|-2.10|0.8163
70958774|NCT03486457|141421393|SUPERIORITY||LS mean difference|2.23|STANDARD_ERROR_OF_MEAN|1.368||0.1048|TWO_SIDED|95.0|-0.47|4.93|||Mixed Models Analysis|||Month 6, Role - Emotional Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.93|-0.47|0.1048
70958775|NCT03486457|141421393|SUPERIORITY||LS mean difference|0.71|STANDARD_ERROR_OF_MEAN|1.392||0.6118|TWO_SIDED|95.0|-2.04|3.45|||Mixed Models Analysis|||Month 6, Mental Health Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||3.45|-2.04|0.6118
70958776|NCT03486457|141421393|SUPERIORITY||LS mean difference|0.39|STANDARD_ERROR_OF_MEAN|1.014||0.6996|TWO_SIDED|95.0|-1.61|2.39|||Mixed Models Analysis|||Month 6, Physical Component Summary: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||2.39|-1.61|0.6996
70958777|NCT03486457|141421393|SUPERIORITY||LS mean difference|1.78|STANDARD_ERROR_OF_MEAN|1.424||0.2122|TWO_SIDED|95.0|-1.03|4.59|||Mixed Models Analysis|||Month 6, Mental Component Summary: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.59|-1.03|0.2122
70958778|NCT03486457|141421394|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.067||0.0722|TWO_SIDED|95.0|-0.25|0.01|||Mixed Models Analysis|||Month 1, Mobility: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.01|-0.25|0.0722
70958779|NCT03486457|141421394|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.055||0.0035|TWO_SIDED|95.0|-0.27|-0.05|||Mixed Models Analysis|||Month 1, Self-Care: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.05|-0.27|0.0035
70958780|NCT03486457|141421394|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.069||0.0475|TWO_SIDED|95.0|-0.27|0.0|||Mixed Models Analysis|||Month 1, Usual Activities: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.00|-0.27|0.0475
70958781|NCT03486457|141421394|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.066||0.0537|TWO_SIDED|95.0|-0.26|0.0|||Mixed Models Analysis|||Month 1, Pain/Discomfort: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.00|-0.26|0.0537
70958782|NCT03486457|141421394|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.062||0.1977|TWO_SIDED|95.0|-0.2|0.04|||Mixed Models Analysis|||Month 1, Anxiety/Depression: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.04|-0.20|0.1977
70958783|NCT03486457|141421394|SUPERIORITY||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.064||0.0001|TWO_SIDED|95.0|-0.38|-0.13|||Mixed Models Analysis|||Month 3, Mobility: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.13|-0.38|0.0001
70958784|NCT03486457|141421394|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.057||0.0018|TWO_SIDED|95.0|-0.29|-0.07|||Mixed Models Analysis|||Month 3, Self-Care: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.07|-0.29|0.0018
70879036|NCT03814746|141242890|SUPERIORITY|for time to second occurrence of VOC|Hazard Ratio (HR)|1.29|||||TWO_SIDED|95.0|0.81|2.04|||Cox Model|||||2.04|0.81|
70879037|NCT03814746|141242890|SUPERIORITY||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.59|1.54|||Cox Model|for time to second occurrence of VOC||||1.54|0.59|
70958785|NCT03486457|141421394|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.47|-0.19|||Mixed Models Analysis|||Month 3, Usual Activities: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.19|-0.47|<0.0001
70958786|NCT03486457|141421394|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.073||0.0002|TWO_SIDED|95.0|-0.42|-0.14|||Mixed Models Analysis|||Month 3, Pain/Discomfort: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.14|-0.42|0.0002
70958787|NCT03486457|141421394|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.063||0.0835|TWO_SIDED|95.0|-0.23|0.01|||Mixed Models Analysis|||Month 3, Anxiety/Depression: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.01|-0.23|0.0835
70958788|NCT03486457|141421394|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.056||0.0825|TWO_SIDED|95.0|-0.21|0.01|||Mixed Models Analysis|||Month 6, Mobility: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.01|-0.21|0.0825
70958789|NCT03486457|141421394|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.049||0.5616|TWO_SIDED|95.0|-0.13|0.07|||Mixed Models Analysis|||Month 6, Self-Care: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.07|-0.13|0.5616
70879038|NCT03814746|141242891|SUPERIORITY||Rate ratio|1.03|||||TWO_SIDED|95.0|0.75|1.43|||Negative binomial regression model|for the Annualized rate of all visits to clinics, emergency rooms and hospitalizations||||1.43|0.75|
70879039|NCT03814746|141242891|SUPERIORITY||Rate ratio|0.82|||||TWO_SIDED|95.0|0.59|1.14|||Negative binomial regression model|for the Annualized rate of all visits to clinics, emergency rooms and hospitalizations||||1.14|0.59|
70958790|NCT03486457|141421394|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.065||0.0748|TWO_SIDED|95.0|-0.24|0.01|||Mixed Models Analysis|||Month 6, Usual Activities: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.01|-0.24|0.0748
70958791|NCT03486457|141421394|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.08||0.9477|TWO_SIDED|95.0|-0.15|0.16|||Mixed Models Analysis|||Month 6, Pain/Discomfort: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.16|-0.15|0.9477
70958792|NCT03486457|141421394|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.067||0.3829|TWO_SIDED|95.0|-0.07|0.19|||Mixed Models Analysis|||Month 6, Anxiety/Depression: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.19|-0.07|0.3829
70958793|NCT03486457|141421395|SUPERIORITY||LS mean difference|6.01|STANDARD_ERROR_OF_MEAN|2.084||0.0044|TWO_SIDED|95.0|1.9|10.12|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||10.12|1.90|0.0044
70879040|NCT03814746|141242891|SUPERIORITY||Rate ratio|1.11|||||TWO_SIDED|95.0|0.77|1.59|||Negative binomial regression model|for the Annualized rate of VOC-related visits to clinics, emergency rooms and hospitalizations||||1.59|0.77|
70958794|NCT03486457|141421395|SUPERIORITY||LS mean difference|10.8|STANDARD_ERROR_OF_MEAN|2.578|<|0.0001|TWO_SIDED|95.0|5.71|15.88|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||15.88|5.71|<0.0001
70958795|NCT03486457|141421395|SUPERIORITY||LS mean difference|0.92|STANDARD_ERROR_OF_MEAN|2.442||0.7062|TWO_SIDED|95.0|-3.9|5.74|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.74|-3.90|0.7062
70958796|NCT03486457|141421396|SUPERIORITY||LS mean difference|0.86|STANDARD_ERROR_OF_MEAN|2.404||0.7228|TWO_SIDED|95.0|-3.92|5.63|||Mixed Models Analysis|||Month 3, Work Time Missed: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.63|-3.92|0.7228
70958797|NCT03486457|141421396|SUPERIORITY||LS mean difference|-6.34|STANDARD_ERROR_OF_MEAN|4.561||0.1682|TWO_SIDED|95.0|-15.39|2.72|||Mixed Models Analysis|||Month 3, Impairment While Working: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||2.72|-15.39|0.1682
70958798|NCT03486457|141421396|SUPERIORITY||LS mean difference|-6.21|STANDARD_ERROR_OF_MEAN|4.707||0.19|TWO_SIDED|95.0|-15.56|3.13|||Mixed Models Analysis|||Month 3, Overall Work Impairment: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||3.13|-15.56|0.1900
70958799|NCT03486457|141421396|SUPERIORITY||LS mean difference|-1.08|STANDARD_ERROR_OF_MEAN|2.581||0.6757|TWO_SIDED|95.0|-6.22|4.05|||Mixed Models Analysis|||Month 6, Work Time Missed: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.05|-6.22|0.6757
70958800|NCT03486457|141421396|SUPERIORITY||LS mean difference|-2.38|STANDARD_ERROR_OF_MEAN|4.905||0.6285|TWO_SIDED|95.0|-12.13|7.37|||Mixed Models Analysis|||Month 6, Impairment While Working: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||7.37|-12.13|0.6285
70958801|NCT03486457|141421396|SUPERIORITY||LS mean difference|-2.63|STANDARD_ERROR_OF_MEAN|5.333||0.6228|TWO_SIDED|95.0|-13.23|7.97|||Mixed Models Analysis|||Month 6, Overall Work Impairment: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||7.97|-13.23|0.6228
70958802|NCT03486457|141421397|SUPERIORITY||LS mean difference|-12.81|STANDARD_ERROR_OF_MEAN|3.089|<|0.0001|TWO_SIDED|95.0|-18.9|-6.72|||Mixed Models Analysis|||Month 3, Activity Impairment: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-6.72|-18.90|<0.0001
70958803|NCT03486457|141421397|SUPERIORITY||LS mean difference|1.06|STANDARD_ERROR_OF_MEAN|3.157||0.7384|TWO_SIDED|95.0|-5.17|7.28|||Mixed Models Analysis|||Month 6, Activity Impairment: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||7.28|-5.17|0.7384
70958804|NCT00372229|141421398|SUPERIORITY_OR_OTHER_LEGACY||Difference|-28.5|STANDARD_ERROR_OF_MEAN|5.45|||TWO_SIDED|96.0|-39.7|-17.3||||||||-17.3|-39.7|
70958805|NCT00372229|141421399|SUPERIORITY_OR_OTHER_LEGACY||Difference|-11.3|STANDARD_ERROR_OF_MEAN|3.83|||TWO_SIDED|96.0|-19.2|-3.4||||||||-3.4|-19.2|
70958806|NCT00372229|141421400|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2509|STANDARD_ERROR_OF_MEAN|0.1838||0.1739|TWO_SIDED|99.0|-0.2271|0.7289|||F-test|||||0.7289|-0.2271|0.1739
70958807|NCT00372229|141421433|OTHER|Descriptive analysis|Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|8.71|||TWO_SIDED|95.0|-20.2|13.9||||||||13.9|-20.2|
70958808|NCT00372229|141421434|OTHER|Descriptive analysis|Mean Difference (Final Values)|12.1|STANDARD_ERROR_OF_MEAN|6.21|||TWO_SIDED|95.0|-0.1|24.2||||||||24.2|-0.1|
70879041|NCT03814746|141242891|SUPERIORITY||Rate ratio|0.87|||||TWO_SIDED|95.0|0.6|1.25|||Negative binomial regression model|for the Annualized rate of VOC-related visits to clinics, emergency rooms and hospitalizations||||1.25|0.60|
70879042|NCT03814746|141242892|SUPERIORITY||Rate ratio|1.34|||||TWO_SIDED|95.0|0.85|2.09|||Negative binomial regression model|for the Annualized days of all visits to clinics, emergency rooms and hospitalizations||||2.09|0.85|
70879043|NCT03814746|141242892|SUPERIORITY||Rate ratio|0.88|||||TWO_SIDED|95.0|0.57|1.38|||Negative binomial regression model|for the Annualized days of all visits to clinics, emergency rooms and hospitalizations||||1.38|0.57|
70879044|NCT03814746|141242892|SUPERIORITY||Rate ratio|1.27|||||TWO_SIDED|95.0|0.77|2.09|||Negative binomial regression model|for the Annualized days of VOC-related visits to clinics, emergency rooms and hospitalizations||||2.09|0.77|
70958809|NCT02700945|141421440|SUPERIORITY|The 12-month Kaplan-Meier estimate will be reported for each arm. The hazard ratio estimate for the treatment effect with its 95% confidence interval will be reported.|Hazard Ratio (HR)|7.4|||<|0.001|TWO_SIDED|95.0|2.6|21.3||A priori threshold is .05|Log Rank||A hazard ratio of \> 1 indicates that continuous monitoring arm is superior to control arm in detecting AF.|H0: h(t) = hT(t) for t ≤ 12 months HA: hC(t) ≠ hT(t) for t ≤ 12 months where hT(t) and hC(t) are the hazard functions of first detected and adjudicated AF at time t for subjects with and without the Reveal LINQ diagnostics for AF, respectively. Hazard functions and survival functions are transformations of each other.||21.3|2.6|<0.001
70958810|NCT00116337|141421445|OTHER|Statistical analyses was performed using a repeated measures analysis of variance and Paired t test. A p value of \< 0.05 was taken as indicating statistical significance.|||||<|0.05|||||||ANOVA|Statistical analyses will be performed using a repeated measures analysis of variance and Paired t test.||Each patient was served as their own control; comparisons was made at various points in the study. Clinical parameters was assessed before the study and also at several end points following the Reconditioning Phase.||||<0.05
70879045|NCT03814746|141242892|SUPERIORITY||Rate ratio|0.87|||||TWO_SIDED|95.0|0.52|1.44|||Negative binomial regression model|for the Annualized days of VOC-related visits to clinics, emergency rooms and hospitalizations||||1.44|0.52|
70879046|NCT03997383|141242927|SUPERIORITY||Median Difference (Net)|14.693||||0.0162|TWO_SIDED|95.0|0.693|28.692||P-value was determined by the Wilcoxon Rank Sum test,stratified by baseline tafamidis use.Analysis was performed on the 100 multiply-imputed datasets.|Wilcoxon Rank Sum Test||Median difference estimated by the Hodges-Lehmann method, stratified by baseline tafamidis use. Analysis was performed on the 100 multiply-imputed datasets.|||28.692|0.693|0.0162
70879047|NCT03997383|141242928|SUPERIORITY||Least squares (LS) mean difference|3.709|STANDARD_ERROR_OF_MEAN|1.796||0.0397|TWO_SIDED|95.0|0.176|7.242||P-value was analyzed using mixed model repeated measures (MMRM) as described in the Statistical analysis plan.|MMRM|||||7.242|0.176|0.0397
70879048|NCT03997383|141242929|SUPERIORITY||Stratified Win Ratio|1.27||||0.0574|TWO_SIDED|95.0|0.99|1.61|||Z-test|P-value was analyzed by a z-test using the mean and variance of the log-transformed win ratio estimate.||||1.61|0.99|0.0574
70879049|NCT03997383|141242930|SUPERIORITY||Hazard Ratio (HR)|0.997||||0.9888|TWO_SIDED|95.0|0.62|1.602|||Andersen-Gill||HR was derived using an Andersen-Gill model, including the treatment arm, type of ATTR amyloidosis, baseline New York Heart Association (NYHA) class, and age as covariates.|||1.602|0.620|0.9888
70958811|NCT00116337|141421447|OTHER||||||<|0.05|||||||nonparametric analog (Freidman Test)|||The data prior to implantation were compared with data obtained after implantation of the cough system using a nonparametric analog (Freidman Test) to the standard repeated measures analysis of variance. Statistical significance was assumed at P\<0.05. This alpha level was chosen as a correlation for inflated type I error rates because of multiple comparisons. Results are reported as means ± SEs.||||<0.05
70958812|NCT02943226|141421475|SUPERIORITY|||||||0.4487|||||||two sample t-test|||||||0.4487
70958813|NCT02943226|141421476|SUPERIORITY|||||||0.0112|||||||Wilcoxon (Mann-Whitney)|||||||0.0112
70958814|NCT02943226|141421477|SUPERIORITY|||||||0.0784|||||||two sample t-test|||||||0.0784
70958815|NCT02996565|141421479|SUPERIORITY||Mean Difference (Net)|-0.76||||0.45|TWO_SIDED|95.0|-2.84|1.33||The threshold for statistical significance was p = 0.05.|planned contrast|The planned contrast compares model-predicted change in SBP from index to 365 days in Telehealth Care vs. Best Practice Clinic-Based Care.|adjusted for baseline SBP, baseline DBP, baseline age, sex, Asian race|||1.33|-2.84|0.45
70958816|NCT02996565|141421480|SUPERIORITY|Random coefficients model predicted all EHR-documented DBPs from treatment group, days elapsed from index to each DBP (time) and treatment group by time with random clinic and patient intercepts.|Mean Difference (Net)|0.28||||0.64|TWO_SIDED|95.0|-0.95|1.51||The threshold for statistical significance was p\<0.05|planned contrast|The planned contrast compares the model-predicted change in DBP from index to 365 days in Telehealth care vs. index to 365 days in clinic based care.|adjusted for baseline SBP, baseline DBP, baseline age, sex, Asian race|||1.51|-0.95|0.64
70879050|NCT03997383|141242931|SUPERIORITY||Hazard Ratio (HR)|0.883||||0.5609|TWO_SIDED|95.0|0.582|1.341|||Modified Andersen-Gill|P-value was derived using the modified Andersen-Gill model stratified by baseline tafamidis use.|HR was derived using the modified Andersen-Gill model stratified by baseline tafamidis use, including treatment arm, type of ATTR amyloidosis, baseline NYHA class, and age as covariates.|||1.341|0.582|0.5609
70879051|NCT06273124|141243102|SUPERIORITY||Kaplan-Meier 7 Day Survival Estimate|95.0|||<|0.001|TWO_SIDED|95.0|94.0|97.0|||Bootstrapping Kaplan-Meier estimates|||Ninety-five percent confidence intervals for the 7-day survival rates and p-values for the survival probabilities being greater than 75% were calculated with a bootstrap to account for the correlated data from having each participant wear multiple infusion sets.||97|94|<0.001
70879052|NCT06273124|141243103|SUPERIORITY||Kaplan-Meier 7 Day Survival Estimate|95.0|||<|0.001|TWO_SIDED|95.0|93.0|96.0|||Bootstrapping Kaplan-Meier estimates|||Ninety-five percent confidence intervals for the 7-day survival rates and p-values for the survival probabilities being greater than 75% were calculated with a bootstrap to account for the correlated data from having each participant wear multiple infusion sets.||96|93|<0.001
70879053|NCT04327388|141243120|SUPERIORITY||Hazard Ratio (HR)|1.026||||0.9561|TWO_SIDED|95.0|0.751|1.402|||Log-rank test|Analyzed based on logrank test stratified by severity of illness (severe, critical) and use of systemic corticosteroids (Yes, No) as entered in IRT.|Hazard ratio for estimation of treatment effect of each sarilumab dose versus placebo was assessed by cox proportional hazard model stratified by severity of illness (severe, critical) and use of systemic corticosteroids (Yes, No) as entered in IRT.|||1.402|0.751|0.9561
70879054|NCT04327388|141243120|SUPERIORITY||Hazard Ratio (HR)|1.135||||0.3376|TWO_SIDED|95.0|0.835|1.543|||Log-rank test|Analyzed based on logrank test stratified by severity of illness (severe, critical) and use of systemic corticosteroids (Yes, No) as entered in IRT.|Hazard ratio for estimation of treatment effect of each sarilumab dose versus placebo was assessed by cox proportional hazard model stratified by severity of illness (severe, critical) and use of systemic corticosteroids (Yes, No) as entered in IRT.|||1.543|0.835|0.3376
70879055|NCT04327388|141243121|SUPERIORITY||Difference in percentage|-1.7||||0.628|TWO_SIDED|95.0|-9.27|5.81|||Cochran-Mantel-Haenszel|By Cochran-Mantel-Haenszel test stratified by severity of illness (severe, critical) and use of systemic corticosteroids (Yes, No) as entered in IRT.||||5.81|-9.27|0.6280
70879056|NCT04327388|141243121|SUPERIORITY||Difference in percentage|0.2||||0.8478|TWO_SIDED|95.0|-6.93|7.41|||Cochran-Mantel-Haenszel|By Cochran-Mantel-Haenszel test stratified by severity of illness (severe, critical) and use of systemic corticosteroids (Yes, No) as entered in IRT.||||7.41|-6.93|0.8478
70958817|NCT02996565|141421481|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.53|||<|0.001|TWO_SIDED|95.0|1.27|1.85||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood pf reporting high satisfaction at 6 months relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.85|1.27|<0.001
70879057|NCT00399360|141243233|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||ANOVA|||||||0.37
70879058|NCT00399360|141243234|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||ANOVA|||||||0.80
70879059|NCT00399360|141243235|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANOVA|||||||0.08
70958818|NCT02996565|141421482|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.25||||0.03|TWO_SIDED|95.0|1.02|1.52||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood pf reporting high satisfaction at 6 months relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.52|1.02|0.03
70879060|NCT00399360|141243236|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||ANOVA|||||||0.13
70879061|NCT00399360|141243237|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANOVA|||||||0.85
70879062|NCT00399360|141243238|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANOVA|||||||0.03
70879063|NCT00399360|141243239|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||ANOVA|||||||0.10
70879064|NCT00399360|141243240|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||ANOVA|||||||0.63
70879065|NCT00399360|141243241|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.05
70879066|NCT00399360|141243242|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|||||||0.02
70879067|NCT01412021|141243243|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
70879068|NCT01412021|141243244|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
70879069|NCT01412021|141243245|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
70879070|NCT01412021|141243246|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
70879071|NCT01412021|141243247|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
70879072|NCT01412021|141243249|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
70879073|NCT01412021|141243251|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
70879074|NCT01412021|141243252|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
70879075|NCT01412021|141243253|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
70879076|NCT01412021|141243254|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
70879077|NCT01412021|141243255|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
70879078|NCT01412021|141243256|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
70879079|NCT01412021|141243257|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
70879080|NCT01412021|141243258|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
70879081|NCT01412021|141243259|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
70879082|NCT01412021|141243260|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
70879083|NCT01412021|141243261|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
70879084|NCT01412021|141243263|SUPERIORITY|||||||0.0132|||||||paired t-test|||||||0.0132
70879085|NCT01412021|141243264|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
70879086|NCT01412021|141243265|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
70879087|NCT01412021|141243266|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
70879088|NCT01412021|141243267|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
70879089|NCT01412021|141243268|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
70879090|NCT01412021|141243269|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
70879091|NCT01412021|141243270|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
70958819|NCT02996565|141421483|SUPERIORITY|Random coefficients model predicted the likelihood that smoking was current 12 months by treatment group with random clinic intercept.|Risk Ratio (RR)|1.01||||0.73|TWO_SIDED|95.0|0.95|1.07||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The risk ratio compares the likelihood of current smoking at 12 months in Telehealth care vs. clinic based care|unadjusted|||1.07|0.95|0.73
70958820|NCT02996565|141421484|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.17||||0.08|TWO_SIDED|95.0|0.98|1.4||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the side effect was a problem at 6m relative to baseline in Telehealth vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.4|.98|0.08
70958821|NCT02996565|141421485|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.11||||0.18|TWO_SIDED|95.0|0.95|1.29||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the side effect was a problem at 6m relative to baseline in Telehealth vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.29|0.95|0.18
70958822|NCT02996565|141421486|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.98||||0.77|TWO_SIDED|95.0|0.87|1.11||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the side effect was a problem at 6m relative to baseline in Telehealth vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.11|0.87|0.77
70958823|NCT02996565|141421487|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.93||||0.32|TWO_SIDED|95.0|0.8|1.08||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the side effect was a problem at 6m relative to baseline in Telehealth vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.08|0.80|0.32
70879092|NCT01412021|141243271|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
70879093|NCT01412021|141243272|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
70958824|NCT02996565|141421488|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.95||||0.62|TWO_SIDED|95.0|0.76|1.19||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the side effect was a problem at 6m relative to baseline in Telehealth vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.19|0.76|0.62
70958825|NCT02996565|141421489|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.99||||0.87|TWO_SIDED|95.0|0.91|1.08||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the side effect was a problem at 6m relative to baseline in Telehealth vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.08|0.91|0.87
70958826|NCT02996565|141421490|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.95||||0.51|TWO_SIDED|95.0|0.82|1.11||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the activity is helpful at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.11|0.82|0.51
70958827|NCT02996565|141421491|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.09||||0.41|TWO_SIDED|95.0|0.87|1.37||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the activity is helpful at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.37|0.87|0.41
70958828|NCT02996565|141421492|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.9||||0.18|TWO_SIDED|95.0|0.77|1.06||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the activity was helpful at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.06|0.77|0.18
70958829|NCT02996565|141421493|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.92||||0.31|TWO_SIDED|95.0|0.78|1.09||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the activity is helpful at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.09|0.78|0.31
70958830|NCT02996565|141421494|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.04||||0.56|TWO_SIDED|95.0|0.89|1.22||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the activity is helpful at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.22|0.89|0.56
70958831|NCT02996565|141421495|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.84||||0.08|TWO_SIDED|95.0|0.68|1.03||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.03|0.68|0.08
70958832|NCT02996565|141421496|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.9||||0.32|TWO_SIDED|95.0|0.73|1.11||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.11|.73|0.32
70958833|NCT02996565|141421497|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.14||||0.09|TWO_SIDED|95.0|0.98|1.33||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.33|0.98|0.09
70958834|NCT02996565|141421498|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.98||||0.77|TWO_SIDED|95.0|0.83|1.16||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.16|0.83|0.77
70958835|NCT02996565|141421499|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.21||||0.09|TWO_SIDED|95.0|0.97|1.5||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.5|.97|0.09
70958836|NCT02996565|141421500|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.64||||0.02|TWO_SIDED|95.0|0.45|0.92||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||0.92|0.45|0.02
70958837|NCT02996565|141421501|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.7||||0.006|TWO_SIDED|95.0|0.55|0.89||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||.89|.55|0.006
70958838|NCT02996565|141421502|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.78||||0.06|TWO_SIDED|95.0|0.6|1.01||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.01|0.60|0.06
70879094|NCT00529542|141243291|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.58|TWO_SIDED|95.0|-9.3|5.3||All hypotheses tests were two-sided.|Linear mixed-effects models|Linear mixed-effects models were fit to continuous outcomes to assess the change from baseline to 6 weeks between groups.|This analysis revealed that the required sample size was 235 subjects per group for 80% power to detect an absolute 2% increase in FMD with Atorvastatin vs. Placebo. We stopped the trial because we had insufficient funds for the required sample size.|This study was initiated as a pilot study with the goal of enrolling 19 women in each group, which we hypothesized would provide 80% power to detect an absolute difference in the change in FMD from baseline between the two groups (Atorvastatin vs. Placebo) of 3.75%, assuming a common standard deviation (SD) of 4%, using a two-sided, two-sample t-test with α=0.05. Recruitment was slow due to strict inclusion/ exclusion criteria so we analyzed our data after the first 20 women completed the study.||5.3|-9.3|0.58
70879095|NCT00529542|141243292|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7||||0.39|TWO_SIDED|95.0|-0.9|2.3|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||2.3|-0.9|0.39
70879096|NCT00529542|141243293|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-70.8|||<|0.001|TWO_SIDED|95.0|-95.2|-46.4|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||-46.4|-95.2|<0.001
70879097|NCT00529542|141243294|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-57.6|||<|0.001|TWO_SIDED|95.0|-79.3|-35.9|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||-35.9|-79.3|<0.001
70879098|NCT00529542|141243295|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.4||||0.26|TWO_SIDED|95.0|-2.7|9.5|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||9.5|-2.7|0.26
70879099|NCT00529542|141243296|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-82.2|||<|0.001|TWO_SIDED|95.0|-126.2|-38.1|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||-38.1|-126.2|<0.001
70958839|NCT02996565|141421503|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.02||||0.65|TWO_SIDED|95.0|0.94|1.1||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting very/extremely confident at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.10|0.94|0.65
70958840|NCT02996565|141421504|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.02||||0.83|TWO_SIDED|95.0|0.83|1.25||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting very/extremely confident at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.25|0.83|0.83
70958841|NCT02996565|141421505|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.04||||0.41|TWO_SIDED|95.0|0.95|1.13||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting very/extremely confident at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.13|0.95|0.41
70958842|NCT02996565|141421506|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.04||||0.4|TWO_SIDED|95.0|0.94|1.16||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting very/extremely confident at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.16|0.94|0.40
70958843|NCT02996565|141421507|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.01||||0.74|TWO_SIDED|95.0|0.95|1.07||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting very/extremely confident at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.07|0.95|0.74
70958844|NCT02996565|141421508|SUPERIORITY|Random coefficients model predicted the likelihood that a new statin was current at 12 months by treatment group with random clinic intercept.|Risk Ratio (RR)|1.05||||0.71|TWO_SIDED|95.0|0.81|1.37||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The risk ratio compares the likelihood of a new statin medication that is current at 12 months in Telehealth care vs. clinic based care|adjusted for baseline SBP , baseline DBP, baseline age, sex, Asian race|||1.37|0.81|0.71
70958845|NCT01602562|141421509|SUPERIORITY_OR_OTHER||percentage of participants|0.0|||||TWO_SIDED|95.0|0.0|16.11|||||The estimated value reflects the percentage of participants with an HSV infection.|||16.11|0.00|
70958846|NCT01602562|141421509|SUPERIORITY_OR_OTHER||percentage of participants|0.0|||||TWO_SIDED|95.0|0.0|17.65|||||The estimated value reflects the percentage of participants with an HSV infection.|||17.65|0.00|
70958847|NCT03881553|141421524|OTHER|Non-parametric Friedmans||||||0.081||||||χ2 =5.03|Friedman's|||||||0.081
70958848|NCT03881553|141421524|OTHER|Post hoc: Wilcoxon||||||0.05||||||ON1 compared to OFF1|Wilcoxon (Mann-Whitney)|||||||0.05
70958849|NCT03881553|141421524|OTHER|Post Hoc Wilcoxon||||||0.021||||||ON1 compared to OFF2|Wilcoxon (Mann-Whitney)|||||||0.021
70958850|NCT01959516|141421528|SUPERIORITY_OR_OTHER|||||||0.025|||||||Mixed Models Analysis|||||||0.0250
70958851|NCT01959516|141421529|SUPERIORITY_OR_OTHER|||||||0.1439|||||||Mixed Models Analysis|||||||0.1439
70958852|NCT04217590|141421580|SUPERIORITY||Odds Ratio (OR)|5.1|||<|0.001|TWO_SIDED|95.0|1.9|15.12|||Fisher Exact||The CI for OR is calculated as an exact CI. An OR \> 1 favours SZC.|||15.12|1.90|<0.001
70958853|NCT04217590|141421581|SUPERIORITY||Odds Ratio (OR)|6.41|||<|0.001|TWO_SIDED|95.0|2.64|15.55|||Regression, Logistic|The OR, 95% CI and p-value are obtained from a pooled logistic regression model after multiple imputation (MI) of missing pre-dialysis S-K values.|An OR \> 1 favours SZC.|||15.55|2.64|<0.001
70958854|NCT04217590|141421582|SUPERIORITY||Odds Ratio (OR)|6.41|||<|0.001|TWO_SIDED|95.0|2.71|15.12|||Regression, Logistic|The OR, 95% CI and p-value are obtained from a pooled logistic regression model after multiple imputation (MI) of missing pre-dialysis S-K values.|An OR \> 1 favours SZC.|||15.12|2.71|<0.001
70958855|NCT04217590|141421583|SUPERIORITY||Odds Ratio (OR)|4.41|||<|0.001|TWO_SIDED|95.0|2.53|7.67|||Generalised linear mixed model (GLMM)|The p-value was obtained from a test of equality of odds ratios.|The OR was obtained from GLMM model with random intercept and logit link. Treatment, visit, visit by treatment interaction and baseline were specified as fixed effects. An OR \> 1 favours SZC.|||7.67|2.53|<0.001
70958856|NCT04217590|141421584|SUPERIORITY||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|0.77|1.64|||||Endpoint analysed with Generalised linear mixed model. The CI for the mean difference was calculated by bootstrapping. A mean difference \> 0 favours SZC.|||1.64|0.77|
70958857|NCT04217590|141421585|SUPERIORITY||Odds Ratio (OR)|5.82|||<|0.001|TWO_SIDED|95.0|3.15|10.73|||Generalised linear mixed model (GLMM)|The p-value was obtained from a test of equality of odds ratios.|The OR was obtained from GLMM model with random intercept and logit link. Treatment, visit, visit by treatment interaction and baseline were specified as fixed effects. An OR \> 1 favours SZC.|||10.73|3.15|<0.001
70879100|NCT00529542|141243297|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3||||0.45|TWO_SIDED|95.0|-12.4|5.8|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||5.8|-12.4|0.45
70879101|NCT00529542|141243298|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5||||0.33|TWO_SIDED|95.0|-2.8|7.9|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||7.9|-2.8|0.33
70879102|NCT00529542|141243299|SUPERIORITY_OR_OTHER||Mean Difference (Net)|586.0||||0.61|TWO_SIDED|95.0|-1811.0|2983.0|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||2983|-1811|0.61
70879103|NCT00529542|141243300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3385.0||||0.07|TWO_SIDED|95.0|-287.0|7056.0|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||7056|-287|0.07
70879104|NCT00529542|141243301|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8||||0.88|TWO_SIDED|95.0|-24.1|27.8|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||27.8|-24.1|0.88
70879105|NCT00529542|141243302|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|||<|0.001|TWO_SIDED|95.0|-1.6|-0.5|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||-0.5|-1.6|<0.001
70879106|NCT00529542|141243303|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-364.3||||0.02|TWO_SIDED|95.0|-655.3|-73.2|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||-73.2|-655.3|0.02
70879107|NCT00529542|141243304|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4||||0.21|TWO_SIDED|95.0|-6.4|1.5|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||1.5|-6.4|0.21
70879108|NCT00529542|141243305|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.9||||0.27|TWO_SIDED|95.0|-16.9|5.0|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||5.0|-16.9|0.27
70879109|NCT00529542|141243306|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.8||||0.05|TWO_SIDED|95.0|-15.8|0.1|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||0.1|-15.8|0.05
70879110|NCT00529542|141243307|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.5||||0.48|TWO_SIDED|95.0|-6.8|13.7|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||13.7|-6.8|0.48
70879111|NCT00529542|141243308|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.63|TWO_SIDED|95.0|-0.6|1.0|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||1.0|-0.6|0.63
70879112|NCT05778786|141243309|SUPERIORITY|A superiority margin of 0.0 logMAR was used.|Least-Square Mean|-0.13|STANDARD_ERROR_OF_MEAN|0.012|||ONE_SIDED|95.0||-0.1|||Linear Mixed Model|||It was calculated using a 1-sided one sample mean t-test with a type I error rate of 0.025 that 9 subjects provide at least 99% statistical power to test for superiority.||-0.10||
70879113|NCT05778786|141243310|SUPERIORITY|A superiority margin of 62 points was used.|Least-quares mean|69.4|STANDARD_ERROR_OF_MEAN|2.13|||ONE_SIDED|95.0|65.2||||Linear Mixed Model|||It was calculated using a 1-sided one sample mean t-test with a type I error rate of 0.025 that 165 subjects provide at least 99% statistical power to test for superiority.|||65.2|
70879114|NCT05778786|141243311|SUPERIORITY|A superiority margin of 0.80 was used|Mean Central Posterior Proportion|0.974|STANDARD_DEVIATION|0.01|||TWO_SIDED|95.0|0.95|0.989|||Bayesian beta- binomial model|Method used is Bayesian beta- binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.99 and an intraclass correlation of 0.70, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible interval.||0.989|0.950|
70879115|NCT05778786|141243312|SUPERIORITY|A superiority margin of 0.80 was used|Mean Central Posterior Proportion|0.989|STANDARD_DEVIATION|0.0054|||TWO_SIDED|95.0|0.976|0.997|||Bayesian beta-binomial model|Method used is Bayesian beta- binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.99 and an intraclass correlation of 0.70, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible interval.||0.997|0.976|
70879116|NCT05778786|141243313|SUPERIORITY|A superiority margin of 0.80 was used|Mean Central Posterior Proportion|0.989|STANDARD_DEVIATION|0.0053|||TWO_SIDED|95.0|0.977|0.997|||Bayesian beta- binomial model|Method used is Bayesian beta- binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.99 and an intraclass correlation of 0.70, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible interval.||0.997|0.977|
70958858|NCT04619251|141421587|OTHER|Since the main focus is on estimation and not testing, a formal hypothesis test and associated acceptance range is not specified.|Geometric Least Squares Mean ratio (%)|337.6|||||TWO_SIDED|90.0|302.8|376.4|||||Geometric Least Squares Mean ratio was estimated by the ratios of the geometric means (T/R). Intra-individual geometric coefficient variation (gCV %) =15.9|The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: subject and treatment. The effect 'subject' was considered as random, whereas the effect 'treatment' was considered as fixed. These quantities were then back-transformed to the original scale.||376.4|302.8|
70958859|NCT04619251|141421588|OTHER|Since the main focus is on estimation and not testing, a formal hypothesis test and associated acceptance range is not specified.|Geometric Least Squares Mean ratio (%)|184.4|||||TWO_SIDED|90.0|156.0|218.0|||||Geometric Least Squares Mean ratio was estimated by the ratios of the geometric means (T/R). Intra-individual geometric coefficient variation (gCV %) =26.4|The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: subject and treatment. The effect 'subject' was considered as random, whereas the effect 'treatment' was considered as fixed. These quantities were then back-transformed to the original scale.||218.0|156.0|
70958860|NCT04619251|141421589|OTHER|Since the main focus is on estimation and not testing, a formal hypothesis test and associated acceptance range is not specified.|Geometric Least Squares Mean ratio (%)|356.8|||||TWO_SIDED|90.0|315.7|403.2|||||Geometric Least Squares Mean ratio was estimated by the ratios of the geometric means (T/R). Intra-individual geometric coefficient variation (gCV %) =18.4|The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: subject and treatment. The effect 'subject' was considered as random, whereas the effect 'treatment' was considered as fixed. These quantities were then back-transformed to the original scale.||403.2|315.7|
70958861|NCT00803751|141421603|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Fisher Exact|||||||0.17
70879117|NCT05778786|141243314|SUPERIORITY|A superiority margin of 0.05 was used.|Mean Central Posterior Proportion|0.003|STANDARD_DEVIATION|0.0028|||TWO_SIDED|95.0|0.0|0.01|||Bayesian beta-binomial model|Bayesian beta- binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.01 and an intraclass correlation of 0.70, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible Interval.||0.010|0.000|
70879118|NCT05778786|141243315|SUPERIORITY|A superiority margin of 58 points was used.|Least-squares Mean|66.1|STANDARD_ERROR_OF_MEAN|2.48|||ONE_SIDED|95.0|61.2||||Linear Mixed Model|||It was calculated using a 1-sided one sample mean t-test with a type I error rate of 0.025 that 135 subjects provide at least 97% statistical power to test for superiority.|||61.2|
70879119|NCT05778786|141243316|SUPERIORITY|A superiority margin of 61 points was used.|Least-squares Mean|69.9|STANDARD_ERROR_OF_MEAN|1.66|||ONE_SIDED|95.0|66.6||||Linear Mixed Model|||It was calculated using a 1-sided one sample mean t-test with a type I error rate of 0.025 that 135 subjects provide at least 97% statistical power to test for superiority.|||66.6|
70958862|NCT00803751|141421604|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||Fisher Exact|||||||0.45
70958863|NCT00803751|141421605|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||t-test, 2 sided|||||||0.36
70958864|NCT00803751|141421606|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||||||0.002
70958865|NCT00803751|141421607|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
70958866|NCT00803751|141421608|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||t-test, 2 sided|||||||0.0004
70958867|NCT01242800|141421609|SUPERIORITY|||||||0.32|||||||Log Rank|Stratified log rank test was used for arm comparison||||||0.32
70958868|NCT00953745|141421612|SUPERIORITY_OR_OTHER|||||||0.029||||||paired t-test thresholded at cluster level significance of p=0.001; family-wise error multiple comparisons corrected|t-test, 1 sided|||A region of increased relative Fluorodopa (FDOPA) uptake in the right medial caudate was anticipated for the aripiprazole augmentation responders over the 6 weeks of augmentation treatment (Weeks 10-16).||||0.029
70958869|NCT00953745|141421613|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70958870|NCT00953745|141421613|SUPERIORITY_OR_OTHER|||||||0.366|||||||t-test, 2 sided|||||||0.366
70879120|NCT05413369|141243325|NON_INFERIORITY|The non-inferiority was assessed using the upper bound of the 2-sided 95% confidence interval (CI). Non-inferiority p-value was calculated from a non-inferiority margin of 0.3%.|Least Squares (LS) Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.33|-0.07|||ANCOVA|Treatment groups and randomization stratum of previous oral anti-diabetic drug(OADs) as fixed effects,and baseline HbA1c continuous value as covariate||Statistical analysis for change from baseline in HbA1c||-0.07|-0.33|<0.001
70958871|NCT01395888|141421615|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.259||||0.484|TWO_SIDED|95.0|-0.468|0.986|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)||||0.986|-0.468|0.484
70958872|NCT02640157|141421618|NON_INFERIORITY|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was \>92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm A was \>92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was below 92%.|Difference in percentage of participants|-1.2|||||TWO_SIDED|95.0|-5.6|3.1||||||Difference in SVR12 rates (Arm A - Arm B).||3.1|-5.6|
70958873|NCT02640157|141421618|NON_INFERIORITY|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was \>92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm A was \>92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was below 92%.|percentage of participants|95.3|||||TWO_SIDED|97.5|92.2|98.4||||||||98.4|92.2|
70958874|NCT02640157|141421618|NON_INFERIORITY|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was \>92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm A was \>92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was below 92%.|Difference in percentage of participants|-1.2|||||TWO_SIDED|97.5|-6.2|3.7||||||Difference in SVR12 rates (Arm A - Arm B).||3.7|-6.2|
70958875|NCT02640157|141421619|NON_INFERIORITY|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was \>92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm C was \>92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was below 92%.|Difference in percentage of participants|-0.4|||||TWO_SIDED|95.0|-4.8|4.0||||||Difference in SVR12 rates (Arm C - Arm A)||4.0|-4.8|
70958876|NCT02640157|141421619|NON_INFERIORITY|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was \>92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm C was \>92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was below 92%.|Percentage of participants|94.9|||||TWO_SIDED|97.5|91.0|98.8||||||||98.8|91.0|
70958877|NCT02640157|141421619|NON_INFERIORITY|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was \>92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm C was \>92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was below 92%.|Difference in percentage of participants|-0.4|||||TWO_SIDED|97.5|-5.4|4.6||||||||4.6|-5.4|
70958878|NCT04677179|141421637|SUPERIORITY||Odds Ratio (OR)|0.57||||0.75|TWO_SIDED|95.0|0.03|11.32|||Cochran-Mantel-Haenszel|||||11.32|0.03|0.750
70958879|NCT04677179|141421637|SUPERIORITY||Odds Ratio (OR)|0.8||||0.838|TWO_SIDED|95.0|0.1|6.21|||Cochran-Mantel-Haenszel|||||6.21|0.10|0.838
70958880|NCT04677179|141421638|SUPERIORITY||Odds Ratio (OR)|0.57||||0.563|TWO_SIDED|95.0|0.1|3.3|||Cochran-Mantel-Haenszel|||||3.30|0.10|0.563
70958881|NCT04677179|141421638|SUPERIORITY||Odds Ratio (OR)|0.78||||0.759|TWO_SIDED|95.0|0.17|3.64|||Cochran-Mantel-Haenszel|||||3.64|0.17|0.759
70958882|NCT04677179|141421639|SUPERIORITY||Odds Ratio (OR)|0.18||||0.163|TWO_SIDED|95.0|0.02|1.93|||Cochran-Mantel-Haenszel|||||1.93|0.02|0.163
70958883|NCT04677179|141421639|SUPERIORITY||Odds Ratio (OR)|0.54||||0.439|TWO_SIDED|95.0|0.11|2.77|||Cochran-Mantel-Haenszel|||||2.77|0.11|0.439
70958884|NCT04677179|141421640|SUPERIORITY||Odds Ratio (OR)|1.29||||0.821|TWO_SIDED|95.0|0.17|9.88|||Cochran-Mantel-Haenszel|||||9.88|0.17|0.821
70958885|NCT04677179|141421640|SUPERIORITY||Odds Ratio (OR)|1.43||||0.572|TWO_SIDED|95.0|0.37|5.49|||Cochran-Mantel-Haenszel|||||5.49|0.37|0.572
70958886|NCT04677179|141421641|SUPERIORITY||Odds Ratio (OR)|1.18||||0.886|TWO_SIDED|95.0|0.14|10.16|||Cochran-Mantel-Haenszel|||||10.16|0.14|0.886
70958887|NCT04677179|141421641|SUPERIORITY||Odds Ratio (OR)|0.78||||0.784|TWO_SIDED|95.0|0.14|4.18|||Cochran-Mantel-Haenszel|||||4.18|0.14|0.784
70958888|NCT04677179|141421642|SUPERIORITY||Odds Ratio (OR)|0.37||||0.331|TWO_SIDED|95.0|0.06|2.43|||Cochran-Mantel-Haenszel|||||2.43|0.06|0.331
70958889|NCT04677179|141421642|SUPERIORITY||Odds Ratio (OR)|0.51||||0.407|TWO_SIDED|95.0|0.1|2.52|||Cochran-Mantel-Haenszel|||||2.52|0.10|0.407
70958890|NCT04677179|141421643|SUPERIORITY||Risk Ratio (RR)|1.5||||0.564|TWO_SIDED|95.0|0.38|6.0|||Cochran-Mantel-Haenszel|||||6.00|0.38|0.564
70879121|NCT05413369|141243326|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.003|TWO_SIDED|97.5|-0.35|-0.05|||ANCOVA|Treatment groups and randomization stratum of previous as fixed effects, and baseline HbA1c continuous value as covariate||Statistical analysis for change from baseline in HbA1c||-0.05|-0.35|0.003
70879122|NCT05413369|141243327|SUPERIORITY||LS Mean Difference|-1.49|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|97.5|-2.32|-0.66|||ANCOVA|Treatment groups, randomization stratums of HbA1c and previous OADs as fixed effects, and baseline body weight continuous value as covariate.||Statistical analysis for change from baseline in body weight||-0.66|-2.32|<0.001
70958891|NCT04677179|141421643|SUPERIORITY||Risk Ratio (RR)|1.51||||0.681|TWO_SIDED|95.0|0.21|10.97|||Cochran-Mantel-Haenszel|||||10.97|0.21|0.681
70879123|NCT05413369|141243328|SUPERIORITY||Odds Ratio (OR)|1.89|||<|0.001|TWO_SIDED|97.5|1.25|2.85|||Regression, Logistic|Adjusted for treatment group, randomization stratum of previous OADs, and continuous baseline value of HbA1c||Statistical analysis for percentage of participants reaching HbA1c value \<7% at Week 24||2.85|1.25|<0.001
70879124|NCT05413369|141243329|SUPERIORITY||Odds Ratio (OR)|2.59|||<|0.001|TWO_SIDED|95.0|1.79|3.76|||Regression, Logistic|Adjusted for treatment group, randomization stratum of previous OADs, and continuous baseline value of HbA1c and body weight.||Statistical analysis for percentage of participants reaching HbA1c value \<7% with no body weight gain at Week 24||3.76|1.79|<0.001
70879125|NCT05413369|141243330|SUPERIORITY||Odds Ratio (OR)|2.34|||<|0.001|TWO_SIDED|95.0|1.52|3.6|||Regression, Logistic|Adjusted for treatment group, randomization stratum of previous OADs, and continuous baseline value of HbA1c and body weight.||Statistical analysis for percentage of participants reaching HbA1c value \<7% with no body weight gain at Week 24 and no hypoglycemia during treatment||3.60|1.52|<0.001
70879126|NCT04103892|141243352|SUPERIORITY||Least square (LS) mean difference|-1.26|STANDARD_ERROR_OF_MEAN|1.69||0.46|TWO_SIDED|95.0|-4.6|2.09|||Mixed Models Repeated Measures (MMRM|||||2.09|-4.60|0.46
70879127|NCT04103892|141243353|SUPERIORITY||Least square (LS) mean difference|-5.28|STANDARD_ERROR_OF_MEAN|2.34||0.03|TWO_SIDED|95.0|-9.91|-0.65|||Mixed Models Repeated Measures (MMRM)|||||-0.65|-9.91|0.03
70879128|NCT01602380|141243416|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.797||||0.0486|TWO_SIDED|95.0|0.637|0.999||2-sided p-value|Log Rank|Stratified log-rank test with factors for prior chemotherapy for locally advanced or metastatic disease and measurable disease at baseline.|A hazard ratio \< 1 favours fulvestrant.|If the true PFS HR for comparison of fulvestrant vs. anastrozole was 0.69 (likely to correspond to a 45% prolongation of PFS) the study had 90% power to demonstrate a statistically significant difference for PFS with a one-sided type 1 error of 2.5% (two-sided 5%).||0.999|0.637|0.0486
70879129|NCT01602380|141243417|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.966||||0.7579|TWO_SIDED|95.0|0.773|1.206||2-sided p-value|Log Rank|Stratified log-rank test with factors for prior chemotherapy for locally advanced or metastatic disease and measurable disease at baseline.|A HR of \<1 favours fulvestrant.|65% OS maturity||1.206|0.773|0.7579
70879130|NCT01602380|141243418|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.074||||0.729|TWO_SIDED|95.0|0.716|1.614||2-sided p-value|Regression, Logistic|||||1.614|0.716|0.7290
70879131|NCT01602380|141243420|SUPERIORITY_OR_OTHER_LEGACY||Rato of EDoR|1.52||||0.0367|TWO_SIDED|95.0|1.03|2.26||2-sided p-value|Method of Ellis et al|||||2.26|1.03|0.0367
70879132|NCT01602380|141243421|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.253||||0.3045|TWO_SIDED|95.0|0.815|1.932||2-sided p-value|Regression, Logistic|||||1.932|0.815|0.3045
70879133|NCT01602380|141243423|SUPERIORITY_OR_OTHER_LEGACY||Ratio of EDoCB|1.26||||0.0561||95.0|0.99|1.59||2-sided p-value|Method of Ellis et al|||||1.59|0.99|0.0561
70879134|NCT01602380|141243424|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.2846|TWO_SIDED|95.0|0.7|1.11||2-sided p-value|Log Rank|Stratified log-rank test with factors for prior chemotherapy for locally advanced/metastatic disease and measurable/non-measurable disease at baseline|A hazard ratio \< 1 favours fulvestrant.|Comparative statistical analysis for time to deterioration of TOI score is presented (fulvestrant versus anastrozole).||1.11|0.70|0.2846
70879135|NCT01602380|141243424|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.0844|TWO_SIDED|95.0|0.66|1.03||2-sided p-value|Log Rank|Stratified log-rank test with factors for prior chemotherapy for locally advanced/metastatic disease and measurable/non-measurable disease at baseline|A hazard ratio \< 1 favours fulvestrant.|Comparative statistical analysis for time to deterioration of FACT-B total score is presented (fulvestrant versus anastrozole).||1.03|0.66|0.0844
70879136|NCT03658538|141243425|SUPERIORITY||Mean Difference (Final Values)|-4.4||||0.025|TWO_SIDED|95.0|-8.2|-0.5||P-value corresponds to the statistical significance of the group difference (active vs. control) in the primary outcome, and was not adjusted for the multiple comparison and based on the a priori threshold for statistical significance (P\<0.05).|Generalized Linear Mixed Model (GLMM)|The analysis was adjusted for covariates.||||-0.5|-8.2|0.025
70879137|NCT03658538|141243426|SUPERIORITY|||||||0.061||||||P-value corresponds to the statistical significance of the group difference (active vs. control) in the primary outcome, and was not adjusted for the multiple comparison and based on the a priori threshold for statistical significance (P\<0.05).|Generalized Linear Mixed Model (GLMM)|The analysis was adjusted for covariates.||||||0.061
70879138|NCT05478252|141243506|NON_INFERIORITY|Non-inferiority of insulin semaglutide J versus insulin semaglutide B was considered as confirmed if the 95% confidence interval (CI) for the mean treatment difference lied entirely below 2.5%. Non-inferiority was investigated on the FAS.|Treatment difference|-0.11|||<|0.0001|TWO_SIDED|95.0|-0.3|0.08|||ANCOVA|||||0.08|-0.30|<.0001
70879139|NCT03939897|141243518|OTHER|This test is used to compare the survival distributions of different groups in a survival analysis. It's a nonparametric test.||||||0.506|||||||Log Rank|||||||0.5060
70879140|NCT03939897|141243521|OTHER|This test is used to compare the survival distributions of different groups in a survival analysis. It's a nonparametric test.||||||0.2989|||||||Log Rank|||||||0.2989
70879141|NCT01277523|141243546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.055||0.0457|TWO_SIDED|95.0|0.002|0.22||Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo.|Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.220|0.002|0.0457
70958892|NCT04677179|141421644|SUPERIORITY||Risk Difference (RD)|3.6||||0.317|TWO_SIDED|95.0|-3.3|10.4|||Cochran-Mantel-Haenszel|||||10.4|-3.3|0.317
70958893|NCT04677179|141421644|SUPERIORITY||Risk Difference (RD)|6.9||||0.238|TWO_SIDED|95.0|-2.3|16.1|||Cochran-Mantel-Haenszel|||||16.1|-2.3|0.238
70958894|NCT04677179|141421645|SUPERIORITY||LS Mean Difference|9.71|STANDARD_ERROR_OF_MEAN|10.935||0.378|TWO_SIDED|95.0|-12.17|31.6|||ANCOVA|||||31.60|-12.17|0.378
70958895|NCT04677179|141421645|SUPERIORITY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|10.406||0.928|TWO_SIDED|95.0|-21.78|19.88|||ANCOVA|||||19.88|-21.78|0.928
70958896|NCT02641496|141421647|OTHER|ANOVA||||||0.027||||||Significance threshold p\<0.05; one-tailed|ANOVA|||Treatment 1 to Treatment 4 (approximately first 30 days of treatment)||||0.027
70958897|NCT02641496|141421647|OTHER|ANOVA||||||0.919||||||Significance threshold p\<0.05; one-tailed|ANOVA|||Last 30 Days of 1 Year Study||||0.919
70958898|NCT02641496|141421648|OTHER|||||||0.696||||||Significance threshold p\<0.05; one-tailed|ANOVA|||||||0.696
70958899|NCT02641496|141421649|OTHER|||||||0.593||||||Significance threshold p\<0.05; two-tailed|ANOVA|||||||0.593
70958900|NCT02641496|141421650|OTHER|||||||0.925||||||Significance threshold p\<0.05; one-tailed|ANOVA|||||||0.925
70958901|NCT03075410|141421684|OTHER||Ratio|1.07|||||TWO_SIDED|90.0|0.87|1.34|||||Mixed Effect Model has been used to assess Food Effect for the log transformed parameter AUC(0-t). Treatment in the fed/fasted state is fitted as Fixed Effect. Participant is fitted as Random Effect. Variance Components covariance structure is used.|||1.34|0.87|
70958902|NCT03075410|141421685|OTHER||Ratio|0.94|||||TWO_SIDED|90.0|0.71|1.26|||||Mixed Effect Model has been used to assess Food Effect for the log transformed parameter AUC(0-inf). Treatment in the fed/fasted state is fitted as Fixed Effect. Participant is fitted as Random Effect. Variance Components covariance structure is use|||1.26|0.71|
70958903|NCT03075410|141421686|OTHER||Ratio|0.97|||||TWO_SIDED|90.0|0.76|1.23|||||Mixed Effect Model has been used to assess Food Effect for the log transformed parameter Cmax. Treatment in the fed/fasted state is fitted as Fixed Effect. Participant is fitted as Random Effect. Variance Components covariance structure is used.|||1.23|0.76|
70958904|NCT03075410|141421687|OTHER||Ratio|0.89|||||TWO_SIDED|90.0|0.64|1.23|||||Fixed Effect Model has been used to assess Food Effect for the log transformed parameter t1/2 Treatment in the fed/fasted state is fitted as Fixed Effect.|||1.23|0.64|
70958905|NCT03075410|141421688|OTHER||Median Difference (Final Values)|0.75|||||TWO_SIDED|90.0|-0.5|2.5|||||Hodges-Lehmann estimation is used to calculate the 90% confidence interval.|||2.50|-0.50|
70958906|NCT03075410|141421692|OTHER||Slope|1.1|||||TWO_SIDED|90.0|1.09|1.1|||||Mixed Effect Model has been used to assess Steady State. Day is fitted as a Fixed Effect. Participant is fitted as Random Effect Variance Components covariance structure is used.|Repeat GSK3036656 5mg Day 1-14||1.10|1.09|
70958907|NCT03075410|141421692|OTHER||Slope|1.08|||||TWO_SIDED|90.0|1.07|1.08|||||Mixed Effect Model has been used to assess Steady State. Day is fitted as a Fixed Effect. Participant is fitted as Random Effect Variance Components covariance structure is used.|Repeat GSK3036656 15mg Day 1-14||1.08|1.07|
70958908|NCT03075410|141421693|OTHER||Slope|0.96|||||TWO_SIDED|90.0|0.82|1.1|||||A slope of 1 indicates the pharmacokinetics are dose proportional. A slope greater than 1 indicates the increase in PK is greater than proportional to dose.||Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect and Participant is fitted as Random Effect. An Unstructured covariance structure is used.|1.10|0.82|
70958909|NCT03075410|141421694|OTHER||Slope|1.32|||||TWO_SIDED|90.0|1.24|1.39|||||Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect and Participant is fitted as Random Effect. An Unstructured covariance structure is used.|||1.39|1.24|
70958910|NCT03075410|141421695|OTHER||Slope|0.96|||||TWO_SIDED|90.0|0.81|1.11|||||Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect and Participant is fitted as Random Effect. An Unstructured covariance structure is used.|||1.11|0.81|
70958911|NCT03075410|141421696|OTHER||Slope|1.24|||||TWO_SIDED|90.0|1.15|1.33|||||Day 1.Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect.|||1.33|1.15|
70958912|NCT03075410|141421696|OTHER||Slope|1.06|||||TWO_SIDED|90.0|0.9|1.22|||||Day 14. Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect.|||1.22|0.90|
70958913|NCT03075410|141421697|OTHER||Slope|1.19|||||TWO_SIDED|90.0|0.92|1.46|||||Day 1. Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect.|||1.46|0.92|
70958914|NCT03075410|141421697|OTHER||Slope|1.06|||||TWO_SIDED|90.0|0.89|1.22|||||Day 14. Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect.|||1.22|0.89|
70958915|NCT00346268|141421714|SUPERIORITY_OR_OTHER||least square (LS) mean difference (net)|-7.58|STANDARD_ERROR_OF_MEAN|3.55||0.035|TWO_SIDED|95.0|-14.63|-0.53||Adjusted for treatment group and center|ANOVA|||||-0.53|-14.63|0.035
70958916|NCT00346268|141421715|SUPERIORITY_OR_OTHER||least square (LS) mean difference (net)|-15.16|STANDARD_ERROR_OF_MEAN|5.2||0.004|TWO_SIDED|95.0|-25.47|-4.85||Adjusted for treatment group and center|ANOVA|||||-4.85|-25.47|0.004
70958917|NCT00346268|141421716|SUPERIORITY_OR_OTHER|||||||0.257||95.0|||||Log Rank|Stratified by center||||||0.257
70958918|NCT00346268|141421717|SUPERIORITY_OR_OTHER||LS mean difference (net)|-0.07|STANDARD_ERROR_OF_MEAN|0.3||0.81|TWO_SIDED|95.0|-0.68|0.53||Adjusted for treatment group and center|ANCOVA|Covariates:Total RBCUs and RBCUs substituted during surgery, baseline hemoglobin, swab and lavage weights, intraoperative blood loss fluid volume||||0.53|-0.68|0.810
70958919|NCT00346268|141421719|SUPERIORITY_OR_OTHER||Least squares mean difference (net)|0.17|STANDARD_ERROR_OF_MEAN|0.09||0.07|TWO_SIDED|95.0|-0.01|0.35|||ANOVA|||The difference in pain at rest prior to administration and pain at rest post administration compared between treatments at 48 hours post surgery.||0.35|-0.01|0.070
70879142|NCT01277523|141243546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.055||0.1039|TWO_SIDED|95.0|-0.019|0.198||Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo.|Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.198|-0.019|0.1039
70879143|NCT01277523|141243547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.059||0.0509|TWO_SIDED|95.0|0.0|0.231||Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo.|Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.231|-0.000|0.0509
70879144|NCT01277523|141243547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.058||0.3605|TWO_SIDED|95.0|-0.061|0.168||Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo.|Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.168|-0.061|0.3605
70879145|NCT01277523|141243548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.059||0.1264|TWO_SIDED|95.0|-0.026|0.207|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.207|-0.026|0.1264
70879146|NCT01277523|141243548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.059||0.2845|TWO_SIDED|95.0|-0.053|0.179|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.179|-0.053|0.2845
70879147|NCT01277523|141243549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.053||0.0338|TWO_SIDED|95.0|0.009|0.217|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.217|0.009|0.0338
70879148|NCT01277523|141243549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.053||0.0999|TWO_SIDED|95.0|-0.017|0.191|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.191|-0.017|0.0999
70879149|NCT01277523|141243550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.057||0.1252|TWO_SIDED|95.0|-0.024|0.198|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.198|-0.024|0.1252
70879150|NCT01277523|141243550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|STANDARD_ERROR_OF_MEAN|0.056||0.3549|TWO_SIDED|95.0|-0.058|0.163|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.163|-0.058|0.3549
70879151|NCT01277523|141243551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.088||0.1819|TWO_SIDED|95.0|-0.055|0.292|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.292|-0.055|0.1819
70879152|NCT01277523|141243551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.088||0.5448|TWO_SIDED|95.0|-0.119|0.226|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.226|-0.119|0.5448
70879153|NCT01277523|141243553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.082||0.4762|TWO_SIDED|95.0|-0.102|0.219|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.219|-0.102|0.4762
70879154|NCT01277523|141243553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036|STANDARD_ERROR_OF_MEAN|0.081||0.6558|TWO_SIDED|95.0|-0.123|0.196|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.196|-0.123|0.6558
70879155|NCT01277523|141243555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.153||0.996|TWO_SIDED|95.0|-0.301|0.3|||Mixed Models Analysis|||||0.300|-0.301|0.9960
70879156|NCT01277523|141243555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.058|STANDARD_ERROR_OF_MEAN|0.151||0.703|TWO_SIDED|95.0|-0.355|0.239|||Mixed Models Analysis|||||0.239|-0.355|0.7030
70879157|NCT01277523|141243556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.032|STANDARD_ERROR_OF_MEAN|0.094||0.7309|TWO_SIDED|95.0|-0.217|0.153|||Mixed Models Analysis|||||0.153|-0.217|0.7309
70879158|NCT01277523|141243556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.049|STANDARD_ERROR_OF_MEAN|0.093||0.5954|TWO_SIDED|95.0|-0.232|0.133|||Mixed Models Analysis|||||0.133|-0.232|0.5954
70879159|NCT01277523|141243557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.083||0.2841|TWO_SIDED|95.0|-0.074|0.252|||Mixed Models Analysis|||||0.252|-0.074|0.2841
70879160|NCT01277523|141243557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.082||0.795|TWO_SIDED|95.0|-0.14|0.182|||Mixed Models Analysis|||||0.182|-0.140|0.7950
70879161|NCT01277523|141243558|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.9671|TWO_SIDED|95.0|0.07|16.95|||Regression, Cox|||||16.95|0.07|0.9671
70879162|NCT01277523|141243558|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.06||||0.5557|TWO_SIDED|95.0|0.19|22.7|||Regression, Cox|||||22.70|0.19|0.5557
70879163|NCT01277523|141243559|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.3567|TWO_SIDED|95.0|0.41|1.38|||Regression, Cox|||||1.38|0.41|0.3567
70879164|NCT01277523|141243559|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.1168|TWO_SIDED|95.0|0.32|1.14|||Regression, Cox|||||1.14|0.32|0.1168
70879165|NCT02389998|141243588|SUPERIORITY||||||<|0.03|||||||ANCOVA|||||||<0.03
70879166|NCT02389998|141243589|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||.001
70879167|NCT02389998|141243590|SUPERIORITY|||||||0.3|||||||McNemar|||||||0.3
70958920|NCT00346268|141421719|SUPERIORITY_OR_OTHER||LS Mean Difference (net)|0.16|STANDARD_ERROR_OF_MEAN|0.09||0.074|TWO_SIDED|95.0|-0.02|0.33|||ANOVA|||The difference in pain at movement prior to administration and pain at movement post administration compared between treatments at 48 hours post surgery.||0.33|-0.02|0.074
70958921|NCT00346268|141421720|SUPERIORITY_OR_OTHER||LS mean difference (net)|-0.71|STANDARD_ERROR_OF_MEAN|0.23||0.002|TWO_SIDED|95.0|-1.16|-0.26||Adjusted for treatment group and center|ANOVA|||24 hours post surgery||-0.26|-1.16|0.002
70958922|NCT00346268|141421720|SUPERIORITY_OR_OTHER||LS mean difference (net)|-0.73|STANDARD_ERROR_OF_MEAN|0.25||0.004|TWO_SIDED|95.0|-1.22|-0.23||Adjusted for treatment group and center|ANOVA|||48 hours post surgery||-0.23|-1.22|0.004
70958923|NCT00346268|141421721|SUPERIORITY_OR_OTHER||LS mean difference (net)|-1.16|STANDARD_ERROR_OF_MEAN|0.3||0.001|TWO_SIDED|95.0|-1.77|-0.56||Adjusted for treatment group and center|ANOVA|||24 hours post surgery||-0.56|-1.77|0.001
70958924|NCT00346268|141421721|SUPERIORITY_OR_OTHER||LS mean difference (net)|-0.83|STANDARD_ERROR_OF_MEAN|0.3||0.006|TWO_SIDED|95.0|-1.41|-0.24||Adjusted for treatment group and center|ANOVA|||48 hours post surgery||-0.24|-1.41|0.006
70958925|NCT03938545|141421737|SUPERIORITY||Risk Difference (RD)|21.4|||=|0.1993|TWO_SIDED|95.0|-11.3|54.1||p-values were obtained from a Mantel-Haenszel test stratified by smoking status at baseline comparing RVT-1401 680 mg/Week group to placebo.|Cochran-Mantel-Haenszel||The risk difference was obtained from a weighted average of the difference within each stratum using Cochran Mantel-Haenszel weights.|||54.1|-11.3|=0.1993
70958926|NCT03938545|141421737|SUPERIORITY||Risk Difference (RD)|24.2|||=|0.1016|TWO_SIDED|95.0|-4.8|53.2||p-values were obtained from a Mantel-Haenszel test stratified by smoking status at baseline comparing RVT-1401 340 mg/Week group to placebo.|Cochran-Mantel-Haenszel||The risk difference was obtained from a weighted average of the difference within each stratum using Cochran Mantel-Haenszel weights.|||53.2|-4.8|=0.1016
70958927|NCT03938545|141421737|SUPERIORITY||Risk Difference (RD)|-8.3|||=|0.2963|TWO_SIDED|95.0|-24.0|7.3||p-values were obtained from a Mantel-Haenszel test stratified by smoking status at baseline comparing RVT-1401 255 mg/Week group to placebo.|Cochran-Mantel-Haenszel||The risk difference was obtained from a weighted average of the difference within each stratum using Cochran Mantel-Haenszel weights.|||7.3|-24.0|=0.2963
70958928|NCT03938545|141421739|SUPERIORITY||Least Square Mean Difference|-60.085|||<|0.001|TWO_SIDED|95.0|-88.857|-31.313|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||||-31.313|-88.857|<0.001
70879168|NCT00706979|141243599|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.008|TWO_SIDED|95.0|1.1|1.4|||Regression, Logistic|||A logistic regression model was used to examine the primary hypothesis that NRT-enhanced PQAs would yield a higher rate of any ever-occurring quit attempt.||1.4|1.1|0.008
70879169|NCT00706979|141243600|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.09|TWO_SIDED|95.0|1.0|1.7|||Regression, Logistic|||A logistic regression model was used to examine the secondary hypothesis that NRT-enhanced PQAs would yield a higher rate of 7 days of abstinence at some point during the study.||1.7|1.0|0.09
70958929|NCT03938545|141421739|SUPERIORITY||Least Square Mean Difference|-65.143|||<|0.001|TWO_SIDED|95.0|-91.927|-38.358|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||||-38.358|-91.927|<0.001
70958930|NCT03938545|141421739|SUPERIORITY||Least Square Mean Difference|-37.323|||=|0.0284|TWO_SIDED|95.0|-70.455|-4.19|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||||-4.190|-70.455|=0.0284
70958931|NCT03938545|141421740|SUPERIORITY||Least Square Mean Difference|-73.003|||<|0.001|TWO_SIDED|95.0|-82.309|-63.697|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||Week 13||-63.697|-82.309|<0.001
70958932|NCT03938545|141421740|SUPERIORITY||Least Square Mean Difference|-59.005|||<|0.001|TWO_SIDED|95.0|-67.821|-50.19|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||Week 13||-50.190|-67.821|<0.001
70958933|NCT03938545|141421740|SUPERIORITY||Least Square Mean Difference|-51.836|||<|0.001|TWO_SIDED|95.0|-62.66|-41.012|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||Week 13||-41.012|-62.660|<0.001
70958934|NCT03938545|141421741|SUPERIORITY||Least Square Mean Difference|-81.49|||<|0.001|TWO_SIDED|95.0|-93.203|-69.777|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG1||-69.777|-93.203|<0.001
70958935|NCT03938545|141421741|SUPERIORITY||Least Square Mean Difference|-67.591|||<|0.001|TWO_SIDED|95.0|-78.562|-56.62|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG1||-56.620|-78.562|<0.001
70958936|NCT03938545|141421741|SUPERIORITY||Least Square Mean Difference|-67.233|||<|0.001|TWO_SIDED|95.0|-81.073|-53.394|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG1||-53.394|-81.073|<0.001
70958937|NCT03938545|141421741|SUPERIORITY||Least Square Mean Difference|-74.865|||<|0.001|TWO_SIDED|95.0|-86.898|-62.832|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG2||-62.832|-86.898|<0.001
70879170|NCT00706979|141243601|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.004|TWO_SIDED|95.0|1.1|1.5|||Regression, Logistic|||A logistic regression model was used to examine the primary hypothesis that NRT-enhanced PQAs would yield a higher rate for the primary outcome of any 24hr quit attempt.||1.5|1.1|0.004
70879171|NCT00706979|141243602|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.3|TWO_SIDED|95.0|0.9|1.6|||Regression, Logistic|||A logistic regression model was used to examine the secondary hypothesis that NRT-enhanced PQAs would yield a higher rate for 7 days of abstinence at the six month follow-up.||1.6|0.9|0.3
70879172|NCT01996826|141243603|OTHER|Based on prior studies endothelial rejection episodes tend to occur in the range of about 60% of transplants. We used rates ranging from 50 to 70 % to compute the sample size. We specified the probability of a type 1 error equal to 0.05, study power equal to 80%, a follow-up period of 12 months, and 4% loss to follow-up. Calculations resulted in sample size estimates of between 65 and 124 participants.|Hazard Ratio (HR)|0.35||||0.1|TWO_SIDED|95.0|0.12|1.14|||Log Rank|||Endothelial rejection rates in patients in the treatment group and the control group were calculated using the Kaplan-Meier survival curve. The Kaplan-Meier/product limit estimator is a non-parametric statistical test used to show the probability of an event occurring at a given time interval. The Kaplan-Meier estimator is used to show what the probability of corneal transplant rejection (and therefore transplant survival) after administration of the active treatment or control.||1.14|0.12|0.10
70879173|NCT01996826|141243604|OTHER|The count of ocular adverse events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.|Risk Ratio (RR)|0.92||||0.36|TWO_SIDED|95.0|0.78|1.06|||Fisher Exact|||The incidence of Ocular Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.||1.06|0.78|0.36
70879174|NCT01996826|141243604|OTHER|Mild ocular adverse events for subjects in intervention group and control group were counted and compared.|Risk Ratio (RR)|0.95||||0.82|TWO_SIDED|95.0|0.63|1.4|||Fisher Exact|||The number of mild severity Ocular Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.||1.4|0.63|0.82
70879175|NCT01996826|141243604|OTHER|Moderate severity ocular adverse events for subjects in intervention group and control group were counted and compared.|Risk Ratio (RR)|0.95|||>|0.99|TWO_SIDED|95.0|0.41|2.2|||Fisher Exact|||The number of moderate severity Ocular Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.||2.2|0.41|>0.99
70958938|NCT03938545|141421741|SUPERIORITY||Least Square Mean Difference|-53.198|||<|0.001|TWO_SIDED|95.0|-64.799|-41.596|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG2||-41.596|-64.799|<0.001
70879176|NCT01996826|141243604|OTHER|Severe ocular adverse events for subjects in intervention group and control group were counted and compared.|Risk Ratio (RR)|0.63||||0.51|TWO_SIDED|95.0|0.2|1.9|||Fisher Exact|||Severe ocular adverse events for subjects in intervention group and control group were counted and compared.||1.9|0.20|0.51
70879177|NCT01996826|141243605|OTHER|The incidence of Systematic Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were calculated and compared.|Risk Ratio (RR)|0.92||||0.24|TWO_SIDED|95.0|0.79|1.02|||Fisher Exact|||||1.02|0.79|0.24
70879178|NCT01996826|141243605|OTHER|Mild severity systemic adverse events for subjects in intervention group and control group were counted and compared.|Risk Ratio (RR)|1.62||||0.4|TWO_SIDED|95.0|0.68|3.9|||Fisher Exact|||The number of mild systemic Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.||3.9|0.68|0.40
70879179|NCT01996826|141243605|OTHER|Moderate severity systemic adverse events for subjects in intervention group and control group were counted and compared.|Risk Ratio (RR)|1.95|||>|0.99|TWO_SIDED|95.0|0.26|14.5|||Fisher Exact|||The number of moderate severity systemic Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.||14.5|0.26|>0.99
70879180|NCT01996826|141243605|OTHER|Severe systemic adverse events for subjects in intervention group and control group were counted and compared.|Risk Ratio (RR)|1.9|||>|0.99|TWO_SIDED|95.0|0.26|14.5|||Fisher Exact|||The number of severe systemic Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.||14.5|0.26|>0.99
70879181|NCT02255981|141243614|OTHER|Non-inferiority could be considered if the outcomes were comparable to the most known studies yet published or, in the case of non-treatable disorder, if the acupuncture treatment got to maintain the VA and prevent the losses. There are many known studies with conventional treatment and estimations of the worsening of vision in this pathologies on the time without treatment.|Mean Difference (Final Values)|15.392|||<|0.05|TWO_SIDED|95.0||||"Using the SPSS program and the non-parametrical technic of Wilcoxon it was determined the p-value.~It should be noted that the null hypothesis is that all these eyes should have a zero gain or perhaps a loss in VA at two years of follow-up."|t-test, 1 sided|From this estimation, it is induced that there are differences in results before and after the treatment.|The datum corresponds to the difference in letters seen between exams at the start and the final examination for all participants. Calculi were made by a Microsoft Excel Descriptive Statistics program.|"Besides that it is of interest to compare with the published studies outcomes, realized with anti-VEGF treatments, and with the known expectations of AV lost without treatment, the data were converted in letters ETDRS chart and here are registered the mean number of letters gained or lost in each group.~Ho: Differences between mean measurements before and after are similar H1: Differences between mean measurements before and after are different."|The null hypothesis was no gain or loss in VA. The alternative hypothesis was stabilization or some gain in letters seen over the baseline count.The published studies report a small gain in VA in about a third of participants and only in cases of NV-AMD with conventional treatment, and an expectancy of loss of vision in the other non treated or non-treatable macular diseases. Some of the participants in this trial had had ocular injections without positive change. Non-inferiority in this trial means outcomes of similar magnitude to the known studies.|||<0.05
70879182|NCT00518323|141243618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|3.17||0.508||95.0|-8.36|4.16||The p value was associated with the closed testing procedure using Dunnett's test.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.|The 95% confidence intervals were unadjusted for multiplicity.|If there were approximately 49 subjects per treatment group who had Week 6 (LOCF or end point) PANSS total measurements, the study was expected to have approximately 80% power to detect a clinically relevant difference of 13.2 points between any paliperidone ER group compared with placebo for the primary outcome measure.||4.16|-8.36|0.508
70879183|NCT00518323|141243618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.1|STANDARD_ERROR_OF_MEAN|3.27||0.006||95.0|-16.58|-3.67||The p value was associated with the closed testing procedure using Dunnett's test.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.|The 95% confidence intervals were unadjusted for multiplicity.|If there were approximately 49 subjects per treatment group who had Week 6 (LOCF or end point) PANSS total measurements, the study was expected to have approximately 80% power to detect a clinically relevant difference of 13.2 points between any paliperidone ER group compared with placebo for the primary outcome measure.||-3.67|-16.58|0.006
70879184|NCT00518323|141243618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6|STANDARD_ERROR_OF_MEAN|3.29||0.086||95.0|-13.07|-0.09||The p value was associated with the closed testing procedure using Dunnett's test.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.|The 95% confidence intervals were unadjusted for multiplicity.|If there were approximately 49 subjects per treatment group who had Week 6 (LOCF or end point) PANSS total measurements, the study was expected to have approximately 80% power to detect a clinically relevant difference of 13.2 points between any paliperidone ER group compared with placebo for the primary outcome measure.||-0.09|-13.07|0.086
70879185|NCT00518323|141243619|SUPERIORITY_OR_OTHER|||||||0.968||95.0||||Comparison with placebo was without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment (placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors, and (non-ranked) baseline CGI-S score as a covariate.||||0.968
70958939|NCT03938545|141421741|SUPERIORITY||Least Square Mean Difference|-53.398|||<|0.001|TWO_SIDED|95.0|-67.552|-39.245|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG2||-39.245|-67.552|<0.001
70879186|NCT00518323|141243619|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparison with placebo was without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment (placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors, and (non-ranked) baseline CGI-S score as a covariate.||||<0.001
70958940|NCT03938545|141421741|SUPERIORITY||Least Square Mean Difference|-88.764|||<|0.001|TWO_SIDED|95.0|-103.039|-74.489|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG3||-74.489|-103.039|<0.001
70958941|NCT03938545|141421741|SUPERIORITY||Least Square Mean Difference|-65.714|||<|0.001|TWO_SIDED|95.0|-78.742|-52.686|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG3||-52.686|-78.742|<0.001
70958942|NCT03938545|141421741|SUPERIORITY||Least Square Mean Difference|-66.685|||<|0.001|TWO_SIDED|95.0|-83.157|-50.214|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG3||-50.214|-83.157|<0.001
70958943|NCT03938545|141421741|SUPERIORITY||Least Square Mean Difference|-68.722|||<|0.001|TWO_SIDED|95.0|-80.877|-56.568|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG4||-56.568|-80.877|<0.001
70958944|NCT03938545|141421741|SUPERIORITY||Least Square Mean Difference|-55.554|||<|0.001|TWO_SIDED|95.0|-67.182|-43.926|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG4||-43.926|-67.182|<0.001
70958945|NCT03938545|141421741|SUPERIORITY||Least Square Mean Difference|-53.079|||<|0.001|TWO_SIDED|95.0|-67.948|-38.21|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG4||-38.210|-67.948|<0.001
70958946|NCT02079610|141421754|SUPERIORITY||Mean Difference (Final Values)|10.0|STANDARD_DEVIATION|3.93|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
70958947|NCT02079610|141421755|SUPERIORITY||Mean Difference (Final Values)|8.2|STANDARD_DEVIATION|5.2||0.03|TWO_SIDED||||||Mixed Models Analysis|||||||0.03
70958948|NCT02079610|141421756|SUPERIORITY||Mean Difference (Final Values)|6.8|STANDARD_DEVIATION|3.5||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.01
70958949|NCT01016977|141421759|SUPERIORITY_OR_OTHER|||||||0.9597||95.0||||Week 1|ANCOVA|||||||0.9597
70958950|NCT01016977|141421759|SUPERIORITY_OR_OTHER|||||||0.5538||95.0||||Week 2|ANCOVA|||||||0.5538
70958951|NCT01016977|141421759|SUPERIORITY_OR_OTHER|||||||0.6315||95.0||||Week 4|ANCOVA|||||||0.6315
70958952|NCT01016977|141421759|SUPERIORITY_OR_OTHER|||||||0.5655||95.0||||Week 8|ANCOVA|||||||0.5655
70958953|NCT01016977|141421759|SUPERIORITY_OR_OTHER|||||||0.7917||95.0||||Week 12|ANCOVA|||||||0.7917
70958954|NCT01016977|141421760|SUPERIORITY_OR_OTHER|||||||0.5961||95.0||||Week 1|ANCOVA|||||||0.5961
70958955|NCT01016977|141421760|SUPERIORITY_OR_OTHER|||||||0.2293||95.0||||Week 2|ANCOVA|||||||0.2293
70958956|NCT01016977|141421760|SUPERIORITY_OR_OTHER|||||||0.9852||95.0||||Week 4|ANCOVA|||||||0.9852
70958957|NCT01016977|141421760|SUPERIORITY_OR_OTHER|||||||0.5538||95.0||||Week 8|ANCOVA|||||||0.5538
70958958|NCT01016977|141421760|SUPERIORITY_OR_OTHER|||||||0.654||95.0||||Week 12|ANCOVA|||||||0.6540
70958959|NCT01016977|141421761|SUPERIORITY_OR_OTHER|||||||0.8545||95.0||||Week 1|ANCOVA|||||||0.8545
70958960|NCT01016977|141421761|SUPERIORITY_OR_OTHER|||||||0.2895||95.0||||Week 2|ANCOVA|||||||0.2895
70958961|NCT01016977|141421761|SUPERIORITY_OR_OTHER|||||||0.8234||95.0||||Week 4|ANCOVA|||||||0.8234
70958962|NCT01016977|141421761|SUPERIORITY_OR_OTHER|||||||0.3644||95.0||||Week 8|ANCOVA|||||||0.3644
70958963|NCT01016977|141421761|SUPERIORITY_OR_OTHER|||||||0.654||95.0||||Week 12|ANCOVA|||||||0.6540
70958964|NCT01016977|141421762|SUPERIORITY_OR_OTHER|||||||0.7546||95.0||||Week 1|ANCOVA|||||||0.7546
70958965|NCT01016977|141421762|SUPERIORITY_OR_OTHER|||||||0.7705||95.0||||Week 2|ANCOVA|||||||0.7705
70958966|NCT01016977|141421762|SUPERIORITY_OR_OTHER|||||||0.0259||95.0||||Week 4|ANCOVA|||||||0.0259
70958967|NCT01016977|141421762|SUPERIORITY_OR_OTHER|||||||0.9252||95.0||||Week 8|ANCOVA|||||||0.9252
70958968|NCT01016977|141421762|SUPERIORITY_OR_OTHER|||||||0.2927||95.0||||Week 12|ANCOVA|||||||0.2927
70958969|NCT01016977|141421763|SUPERIORITY_OR_OTHER|||||||0.401||95.0||||Week 1|ANCOVA|||||||0.4010
70958970|NCT01016977|141421763|SUPERIORITY_OR_OTHER|||||||0.0963||95.0||||Week 2|ANCOVA|||||||0.0963
70958971|NCT01016977|141421763|SUPERIORITY_OR_OTHER|||||||0.9291||95.0||||Week 4|ANCOVA|||||||0.9291
70958972|NCT01016977|141421763|SUPERIORITY_OR_OTHER|||||||0.5523||95.0||||Week 8|ANCOVA|||||||0.5523
70958973|NCT01016977|141421763|SUPERIORITY_OR_OTHER|||||||0.2556||95.0||||Week 12|ANCOVA|||||||0.2556
70958974|NCT01016977|141421764|SUPERIORITY_OR_OTHER|||||||0.4037||95.0||||Week 1|ANCOVA|||||||0.4037
70958975|NCT01016977|141421764|SUPERIORITY_OR_OTHER|||||||0.8662||95.0||||Week 2|ANCOVA|||||||0.8662
70958976|NCT01016977|141421764|SUPERIORITY_OR_OTHER|||||||0.5951||95.0||||Week 4|ANCOVA|||||||0.5951
70958977|NCT01016977|141421764|SUPERIORITY_OR_OTHER|||||||0.2349||95.0||||Week 8|ANCOVA|||||||0.2349
70958978|NCT01016977|141421764|SUPERIORITY_OR_OTHER|||||||0.3461||95.0||||Week 12|ANCOVA|||||||0.3461
70958979|NCT01016977|141421765|SUPERIORITY_OR_OTHER|||||||0.725||95.0||||Week 1|ANCOVA|||||||0.7250
70958980|NCT01016977|141421765|SUPERIORITY_OR_OTHER|||||||0.9743||95.0||||Week 2|ANCOVA|||||||0.9743
70958981|NCT01016977|141421765|SUPERIORITY_OR_OTHER|||||||0.9816||95.0||||Week 4|ANCOVA|||||||0.9816
70958982|NCT01016977|141421765|SUPERIORITY_OR_OTHER|||||||0.8809||95.0||||Week 8|ANCOVA|||||||0.8809
70958983|NCT01016977|141421765|SUPERIORITY_OR_OTHER|||||||0.1679||95.0||||Week 12|ANCOVA|||||||0.1679
70958984|NCT01236365|141421774|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Change in LDL-C between Atorvastatin and Placebo|Mixed Models Analysis|||||||<0.0001
70958985|NCT01236365|141421775|SUPERIORITY_OR_OTHER|||||||0.913|TWO_SIDED|||||Change in hsCRP (6months minus 0months) between Atorvastatin and Placebo|Wilcoxon (Mann-Whitney)|||||||0.913
70958986|NCT01236365|141421778|OTHER|||||||0.09|||||||t-test, 2 sided|||||||0.09
70958987|NCT00717067|141421779|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|129.17||||||90.0|92.16|181.04|||ANOVA|||Ratio (%) test (mild) / reference (normal). AUClast was calculated using the log-linear trapezoidal method.||181.04|92.16|
70958988|NCT00717067|141421779|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|88.31||||||90.0|61.97|125.83|||ANOVA|||Ratio (%) test (moderate) / reference (normal). AUClast was calculated using the log-linear trapezoidal method.||125.83|61.97|
70958989|NCT00717067|141421779|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|322.23||||||90.0|171.97|603.78|||ANOVA|||Ratio (%) test (severe) / reference (normal). AUClast was calculated using the log-linear trapezoidal method.||603.78|171.97|
70958990|NCT00717067|141421780|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|151.99||||||90.0|109.53|210.92|||ANOVA|||Ratio (%) test (mild) / reference (normal).||210.92|109.53|
70958991|NCT00717067|141421780|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|115.95||||||90.0|82.23|163.5|||ANOVA|||Ratio (%) test (moderate) / reference (normal).||163.50|82.23|
70958992|NCT00717067|141421781|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|121.01||||||90.0|83.15|176.13|||ANOVA|||Ratio (%) test (mild) / reference (normal).||176.13|83.15|
70958993|NCT00717067|141421781|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|70.9||||||90.0|47.83|105.1|||ANOVA|||Ratio (%) test (moderate) / reference (normal).||105.10|47.83|
70958994|NCT00717067|141421781|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|238.73||||||90.0|106.83|533.48|||ANOVA|||Ratio (%) test (severe) / reference (normal).||533.48|106.83|
70958995|NCT00717067|141421783|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|323.91||||||90.0|174.32|601.88|||ANOVA|||Ratio (%) test (severe) / reference (normal).||601.88|174.32|
70958996|NCT03536143|141421848|SUPERIORITY|||||||0.0216|||||||Log Rank|||||||0.0216
70958997|NCT03536143|141421849|SUPERIORITY|||||||0.0009|||||||Log Rank|||||||0.0009
70879187|NCT00518323|141243619|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||Comparison with placebo was without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment (placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors, and (non-ranked) baseline CGI-S score as a covariate.||||0.021
70958998|NCT00871780|141421889|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Wilcoxon signed rank test|||Baseline, Week 24||||0.0003
70958999|NCT00871780|141421889|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Wilcoxon signed rank test|||Baseline, Week 48||||0.0002
70959000|NCT00871780|141421890|SUPERIORITY_OR_OTHER|||||||0.0148|||||||Wilcoxon signed rank test|||Baseline, Week 24||||0.0148
70959001|NCT00871780|141421890|SUPERIORITY_OR_OTHER|||||||0.0119|||||||Wilcoxon signed rank test|||Baseline, Week 48||||0.0119
70959002|NCT00871780|141421891|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon signed rank test|||Baseline, Week 24||||<0.0001
70959003|NCT00871780|141421891|SUPERIORITY_OR_OTHER|||||||0.0157|TWO_SIDED||||||Wilcoxon signed rank test|||Baseline, Week 48||||0.0157
70959004|NCT00871780|141421892|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon signed rank test|||Baseline, Week 24||||<0.0001
70959005|NCT00871780|141421892|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon signed rank test|||Baseline, Week 48||||<0.0001
70959006|NCT00871780|141421893|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Baseline||||<0.0001
70959007|NCT00871780|141421893|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 24||||<0.0001
70959008|NCT00871780|141421893|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 48||||<0.0001
70959009|NCT00871780|141421894|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Baseline||||<0.0001
70959010|NCT00871780|141421894|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 24||||<0.0001
70959011|NCT00871780|141421894|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 48||||<0.0001
70959012|NCT00871780|141421895|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Baseline||||<0.0001
70959013|NCT00871780|141421895|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 24||||<0.0001
70959014|NCT00871780|141421895|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 48||||<0.0001
70959015|NCT00871780|141421896|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Baseline||||<0.0001
70959016|NCT00871780|141421896|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 24||||<0.0001
70959017|NCT00871780|141421896|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 48||||<0.0001
70959018|NCT00871780|141421897|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Baseline||||<0.0001
70959019|NCT00871780|141421897|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 24||||<0.0001
70959020|NCT00871780|141421897|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 48||||<0.0001
70959021|NCT00871780|141421898|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Baseline||||<0.0001
70959022|NCT00871780|141421898|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 24||||<0.0001
70959023|NCT00871780|141421898|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 48||||<0.0001
70959024|NCT00871780|141421899|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Baseline||||<0.0001
70959025|NCT00871780|141421899|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 24||||0.0016
70959026|NCT00871780|141421899|SUPERIORITY_OR_OTHER|||||||0.0866|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 48||||0.0866
70959027|NCT00871780|141421900|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Baseline||||<0.0001
70959028|NCT00871780|141421900|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 24||||<0.0001
70959029|NCT00871780|141421900|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 48||||<0.0001
70959030|NCT03406260|141421902|NON_INFERIORITY|A p-value \< 0.05 indicates lasmiditan can be declared noninferior to placebo with noninferiority margin of 10 mmHg, i.e. the difference lasmiditan mean minus placebo mean is less than 10 mmHg.|LS Mean Difference (Final Vaules)|-1.63|||<|0.0001|TWO_SIDED|95.0|-1000.0|1.81|||Linear Mixed Effects Model|||||1.81|-1000|<0.0001
70959031|NCT03406260|141421902|NON_INFERIORITY|A p-value \< 0.05 indicates lasmiditan can be declared noninferior to placebo with noninferiority margin of 10 mmHg, i.e. the difference lasmiditan mean minus placebo mean is less than 10 mmHg.|LS Mean Difference (Final Vaules)|-1.35|||<|0.0001|TWO_SIDED|95.0|-1000.0|2.06|||Linear Mixed Effects Model|||||2.06|-1000|<0.0001
70959032|NCT02527343|141421905|SUPERIORITY||Difference in Least Square Mean|-66.83||||0.0009|TWO_SIDED|95.0|-104.17|-29.48|||ANCOVA|||||-29.48|-104.17|0.0009
70959033|NCT02527343|141421906|SUPERIORITY||Difference in Least Square Mean|-25.69||||0.0736|TWO_SIDED|95.0|-54.03|2.65|||ANCOVA|||Month 6||2.65|-54.03|0.0736
70959034|NCT02527343|141421906|SUPERIORITY||Difference in Least Square Mean|-53.33||||0.0039|TWO_SIDED|95.0|-87.71|-18.95|||ANCOVA|||Month 12||-18.95|-87.71|0.0039
70959035|NCT02527343|141421908|SUPERIORITY||Difference in Least Square Mean|0.3||||0.4108|TWO_SIDED|95.0|-0.43|1.03|||ANCOVA|||Month 3||1.03|-0.43|0.4108
70959036|NCT02527343|141421908|SUPERIORITY||Difference in Least Square Mean|0.19||||0.7308|TWO_SIDED|95.0|-0.95|1.34|||ANCOVA|||Month 6||1.34|-0.95|0.7308
70959037|NCT02527343|141421908|SUPERIORITY||Difference in Least Square Mean|-0.2||||0.7511|TWO_SIDED|95.0|-1.45|1.06|||ANCOVA|||Month 9||1.06|-1.45|0.7511
70959038|NCT02527343|141421908|SUPERIORITY||Difference in Least Square Mean|-0.19||||0.7659|TWO_SIDED|95.0|-1.52|1.13|||ANCOVA|||Month 12||1.13|-1.52|0.7659
70959039|NCT00701220|141421922|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||ANOVA|||The data were analyzed using analysis of variance for repeated measures with two groups. The repeated measure was the proportion of circulating blood cells that were positive for aldehyde dehydrogenase using the commercially available Aldofluor assay. The two groups were those with ischemic and non-ischemic cardiomyopathy. This analysis permitted both intergroup and intragroup analysis of the change in aldehyde dehydrogenase positive cells.||||<0.05
70879188|NCT00518323|141243620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|2.1||0.846||95.0|-4.54|3.73||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment (placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||3.73|-4.54|0.846
70879189|NCT00518323|141243620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|2.17|<|0.001||95.0|4.28|12.82||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||12.82|4.28|<0.001
70879190|NCT00518323|141243620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|2.18||0.067||95.0|-0.28|8.33||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||8.33|-0.28|0.067
70879191|NCT00518323|141243621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.1|STANDARD_ERROR_OF_MEAN|4.27||0.058||95.0|-0.29|16.56||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||16.56|-0.29|0.058
70879192|NCT00518323|141243621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.8|STANDARD_ERROR_OF_MEAN|4.4|<|0.001||95.0|8.08|25.43||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||25.43|8.08|<0.001
70879193|NCT00518323|141243621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.5|STANDARD_ERROR_OF_MEAN|4.43||0.003||95.0|4.76|22.23||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||22.23|4.76|0.003
70879194|NCT00518323|141243622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|4.15||0.237||95.0|-13.11|3.26||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||3.26|-13.11|0.237
70879195|NCT00518323|141243622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|4.28||0.119||95.0|-15.15|1.74||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||1.74|-15.15|0.119
70879196|NCT00518323|141243622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|4.34||0.574||95.0|-11.0|6.11||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||6.11|-11.00|0.574
70879197|NCT01514760|141243626|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||ANCOVA|||This a comparison for participants with uncontrolled asthma at baseline and change in scores over time.||||0.03
70879198|NCT03329690|141243645|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|CMH test with region as a stratification factor||||||<0.0001
70879199|NCT02418468|141243663|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.262|TWO_SIDED|95.0|-0.26|0.07|||mixed models for repeated measures (MMRM|||||0.07|-0.26|0.262
70879200|NCT02337907|141243677|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.073||0.7907|TWO_SIDED|95.0|-0.163|0.124||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.124|-0.163|0.7907
70879201|NCT02337907|141243677|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.075||0.7622|TWO_SIDED|95.0|-0.125|0.171||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.171|-0.125|0.7622
70879202|NCT02337907|141243677|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.071||0.8789|TWO_SIDED|95.0|-0.13|0.152||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.152|-0.130|0.8789
70879203|NCT02337907|141243677|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.074||0.0609|TWO_SIDED|95.0|-0.285|0.006||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.006|-0.285|0.0609
70879204|NCT02337907|141243677|SUPERIORITY|H1-0: Mean NTB response of pooled doses of 10 mg QD, 25 mg QD, 25 mg BID and 50 mg QD = Mean NTB response of placebo|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.053||0.5687|TWO_SIDED|95.0|-0.135|0.074||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.074|-0.135|0.5687
70879205|NCT02337907|141243678|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.056||0.8694|TWO_SIDED|95.0|-0.101|0.12||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.||0.120|-0.101|0.8694
70959040|NCT00440999|141421931|NON_INFERIORITY|The primary efficacy analysis tested the non-inferiority of the PA group compared to the comparator group with regard to the crude cure rate on Day 14 using the 2-sided 95% confidence interval (CI) (Newcombe-Wilson score method without continuity correction) and a 10% non-inferiority margin. Non-inferiority was claimed if the lower limit of the 2-sided 95% CI for the difference in cure rates on Day 14 was \>10%.|Difference in cure rate|-0.5|||||TWO_SIDED|95.0|-2.6|1.4|||||Conclusion: non-inferiority between PA \& chloroquine.|"Null hypothesis: The cure rate on Day 14 for the PA group is inferior to the cure rate on Day 14 for the chloroquine group by more than 10%.~Was tested against the alternative:~Alternative hypothesis: The cure rate on Day 14 for the PA group was not inferior to the cure rate on Day 14 for the chloroquine group by more than 10%."||1.4|-2.6|
70959041|NCT04745026|141421940|SUPERIORITY||Least square mean difference|3.37|STANDARD_ERROR_OF_MEAN|1.931|=|0.085|TWO_SIDED|95.0|-0.48|7.21||Randomization factors, baseline score, visit, treatment arm, visit by treatment arm (fixed), and visit repeated within each patient (repeated).|Mixed models for repeated measures|||Irritability (Week 12)||7.21|-0.48|=0.085
70959042|NCT04745026|141421940|SUPERIORITY||Least square mean difference|1.14|STANDARD_ERROR_OF_MEAN|1.16|=|0.3107|TWO_SIDED|95.0|-1.08|3.36|||Mixed models for repeated measures|Randomization factors, baseline score, visit, treatment arm, visit by treatment arm (fixed), and visit repeated within each patient (repeated).||Social Withdrawal Week 12)||3.36|-1.08|=0.3107
70959043|NCT04745026|141421940|SUPERIORITY||Least square mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.695|=|0.9513|TWO_SIDED|95.0|-1.34|1.42|||Mixed models for repeated measures|Randomization factors, baseline score, visit, treatment arm, visit by treatment arm (fixed), and visit repeated within each patient (repeated).||Stereotypic Behavior (Week 12)||1.42|-1.34|=0.9513
70959044|NCT04745026|141421940|SUPERIORITY||Least square mean difference|2.01|STANDARD_ERROR_OF_MEAN|1.943|=|0.305|TWO_SIDED|95.0|-1.86|5.88|||Mixed models repeated measures|Randomization factors, baseline score, visit, treatment arm, visit by treatment arm (fixed), and visit repeated within each patient (repeated).||Hyperactivity/Noncompliance (Week 12)||5.88|-1.86|=0.305
70959045|NCT04745026|141421940|SUPERIORITY||Least square mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.517|=|0.4754|TWO_SIDED|95.0|-1.4|0.66|||Mixed models repeated measures|Randomization factors, baseline score, visit, treatment arm, visit by treatment arm (fixed), and visit repeated within each patient (repeated).||Inappropriate Speech (Week 12)||0.66|-1.4|=0.4754
70959046|NCT04745026|141421941|SUPERIORITY||Least square mean difference|0.45|STANDARD_ERROR_OF_MEAN|2.36|=|0.8506|TWO_SIDED|95.0|-4.26|5.15|||Mixed models for repeated measures|Randomization factors, baseline score, visit, treatment arm, visit by treatment arm (fixed), and visit repeated within each patient (repeated).||Week 12||5.15|-4.26|=0.8506
70959047|NCT04745026|141421942|SUPERIORITY||Odds Ratio (OR)|1.22|||=|0.7087|TWO_SIDED|95.0|0.43|3.51|||Regression, Logistic|Includes treatment arm, randomization variables and baseline score (CGI-S) covariates. Responders achieved a score of 1 or 2 at post-baseline visits.||Responders with 'Very Much Improved' or 'Much Improved' response at week 12||3.51|0.43|=0.7087
70959048|NCT04745026|141421943|SUPERIORITY||||||=|0.6108|||||||Cochran-Mantel-Haenszel|||Week 12||||=0.6108
70959049|NCT01205152|141421955|OTHER|||||||0.002||||||Two-sided with p-value threshold \<0.05 for statistical significance.|Wilcoxon signed-rank test|||Change is relative to Baseline in Study ENB-002-08 (NCT00744042). The RGI-C score represents evaluation of skeletal X-rays at each post-treatment study timepoint compared with pre-treatment X-rays from Study ENB-002-08 using an ordinal scale. Therefore, an RGI-C score is not applicable for radiographs obtained at Baseline.||||0.0020
70959050|NCT02483585|141421989|SUPERIORITY|A sequential testing procedure, specifically, the hierarchical gate-keeping procedures and Hochberg method, was used to maintain the 2-sided study-wise type I error at 0.05 between the primary and efficacy secondary endpoints.|LS Mean Difference|-1.04|||<|0.001|TWO_SIDED|95.0|-1.61|-0.47|||Generalized Linear Mixed Model|||The primary endpoint was analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and prior/current treatment with migraine prophylactic medication), scheduled visit, and the interaction of treatment group with scheduled visit.||-0.47|-1.61|< 0.001
70959051|NCT02483585|141421990|SUPERIORITY||Odds Ratio (OR)|1.59||||0.01|TWO_SIDED|95.0|1.12|2.27|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel (CMH) test after the missing data were imputed as nonresponse, stratified by stratification factors (region and prior/current treatment with migraine prophylactic medication).||2.27|1.12|0.010
70959052|NCT02483585|141421991|SUPERIORITY||LS Mean Difference|-0.59||||0.002|TWO_SIDED|95.0|-0.96|-0.21|||Generalized Linear Mixed Model|||Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and prior/current treatment with migraine prophylactic medication), scheduled visit, and the interaction of treatment group with scheduled visit.||-0.21|-0.96|0.002
70959053|NCT02483585|141421992|SUPERIORITY||Odds Ratio (OR)|1.22||||0.26|TWO_SIDED|95.0|0.87|1.71|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel (CMH) test after the missing data were imputed as nonresponse, stratified by stratification factors (region and prior/current treatment with migraine prophylactic medication).||1.71|0.87|0.26
70959054|NCT02483585|141421993|SUPERIORITY||Odds Ratio (OR)|1.33||||0.13|TWO_SIDED|95.0|0.92|1.9|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel (CMH) test after the missing data were imputed as nonresponse, stratified by stratification factors (region and prior/current treatment with migraine prophylactic medication).||1.90|0.92|0.13
70959055|NCT00912301|141422000|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Dunnett's test|pairwise comparison low dose NaCDC against placebo||||||0.031
70959056|NCT00912301|141422000|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Dunnett's test|pairwise comparison high dose NaCDC against placebo||||||0.010
70959057|NCT00138671|141422030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||||90.0|-0.17|0.36||||||Week 6||0.36|-0.17|
70959058|NCT00138671|141422030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||||90.0|-0.27|0.26||||||Week 12||0.26|-0.27|
70959059|NCT00138671|141422030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||||90.0|-0.29|0.26||||||Week 26||0.26|-0.29|
70959060|NCT00138671|141422030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||||90.0|-0.36|0.2||||||Week 39||0.20|-0.36|
70959061|NCT00138671|141422030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||||90.0|-0.23|0.35||||||Week 52||0.35|-0.23|
70959062|NCT00138671|141422030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||||90.0|-0.29|0.31||||||Week 52 LOCF||0.31|-0.29|
70959063|NCT00138671|141422031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.475||||||90.0|-23.47|14.518||||||Week 6||14.518|-23.47|
70959064|NCT00138671|141422031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.91||||||90.0|-30.04|8.232||||||Week 12||8.232|-30.04|
70959065|NCT00138671|141422031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.84||||||90.0|-42.51|-3.166||||||Week 26||-3.166|-42.51|
70959066|NCT00138671|141422031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.222||||||90.0|-28.52|12.075||||||Week 39||12.075|-28.52|
70959067|NCT00138671|141422031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.329||||||90.0|-29.27|12.616||||||Week 52||12.616|-29.27|
70959068|NCT00138671|141422031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.406||||||90.0|-13.7|16.514||||||Week 52 LOCF||16.514|-13.70|
70959069|NCT00138671|141422032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.884||||||90.0|-0.317|2.084||||||Week 1||2.084|-0.317|
70959070|NCT00138671|141422032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||||90.0|-0.728|1.668||||||Week 2||1.668|-0.728|
70959071|NCT00138671|141422032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.382||||||90.0|-0.815|1.579||||||Week 3||1.579|-0.815|
70959072|NCT00138671|141422032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.405||||||90.0|-0.793|1.602||||||Week 4||1.602|-0.793|
70959073|NCT00138671|141422032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.562||||||90.0|-0.642|1.766||||||Week 6||1.766|-0.642|
70959074|NCT00138671|141422032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.416||||||90.0|-0.809|1.641||||||Week 9||1.641|-0.809|
70959075|NCT00138671|141422032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.019||||||90.0|-1.416|1.454||||||Week 11||1.454|-1.416|
70959076|NCT00138671|141422032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091||||||90.0|-1.127|1.308||||||Week 12||1.308|-1.127|
70959077|NCT00138671|141422032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.309||||||90.0|-1.551|0.934||||||Week 18||0.934|-1.551|
70959078|NCT00138671|141422032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.869||||||90.0|-2.123|0.384||||||Week 26||0.384|-2.123|
70959079|NCT00138671|141422032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.664||||||90.0|-2.968|-0.36||||||Week 39||-0.360|-2.968|
70959080|NCT00138671|141422032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.116||||||90.0|-3.829|-0.403||||||Week 50||-0.403|-3.829|
70959081|NCT00138671|141422032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.801||||||90.0|-3.204|-0.397||||||Week 51||-0.397|-3.204|
70959082|NCT00138671|141422032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.026||||||90.0|-3.384|-0.668||||||Week 52||-0.668|-3.384|
70959083|NCT00138671|141422032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.451||||||90.0|-3.003|0.101||||||Week 52 LOCF||0.101|-3.003|
70959084|NCT01691768|141422102|NON_INFERIORITY|We estimated that we would need to enrol 700 women after taking into account the anticipated loss-to follow-up in order to provide 90% power to demonstrate whether gel use in women attending family planning (intervention) services is similar to, but no more than 20% lower than, gel use among women attending CAPRISA research clinics (control).|Mean Difference (Final Values)|-0.47|||||TWO_SIDED|95.0|-1.16|0.21||||Univariate Linear Mixed Models were used to analyze primary outcome.|The least square mean from the intervention arm was the minuend and the least square mean from the control arm was the subtrahend.|Intent to treat population (all participants who were randomized, met pre-randomization eligibility criteria and who have post-enrollment follow-up data) was used for this analyses.|The primary endpoint was compared using univariate linear mixed model with compound symmetry structure.|0.21|-1.16|
70959085|NCT01691768|141422102|NON_INFERIORITY|We estimated that we would need to enrol 700 women after taking into account the anticipated loss-to follow-up in order to provide 90% power to demonstrate whether gel use in women attending family planning (intervention) services is similar to, but no more than 20% lower than, gel use among women attending CAPRISA research clinics (control)|Median Difference (Final Values)|-0.25|||||TWO_SIDED|95.0|-0.98|0.48||||Univariable Linear Mixed Models was used for the analyses|We calculated the difference in means between the two arms. The mean from the intervention arm was the minuend and the mean from the control arm was the subtrahend.|This is the analyses from the per protocol population (excluding all subsequent data collected from participants who were not dispensed product for more than 120 days).||0.48|-0.98|
70959086|NCT01691768|141422103|SUPERIORITY||Incidence rate ratio|0.96||||0.928|TWO_SIDED|95.0|0.4|2.35|||z-test|We used z-test to compare incidence rates between the arms. We did not use log-rank test because we did not present survival curves.|We calculated incidence rate ratio, where the HIV incidence rate for the intervention arm represents the numerator and the HIV incidence rate for the control arm represents the denominator.|The power was not calculated for all the secondary outcomes.||2.35|0.40|0.928
70959087|NCT01691768|141422104|SUPERIORITY||incidence rate ratio|0.96||||0.895|TWO_SIDED|95.0|0.45|2.04|||z-test|We used z-test to compare pregnancy incidence rates between the arms. We did not use log-rank test because we did not present survival curves.|We calculated incidence rate ratio, where the pregnancy incidence rate for the intervention arm represents the numerator and the pregnancy incidence rate for the control arm represents the denominator.|Power was not calculated for all the secondary outcomes.||2.04|0.45|0.895
70959088|NCT01691768|141422105|SUPERIORITY||Risk Ratio (RR)|1.08||||0.304|TWO_SIDED|95.0|0.94|1.24|||Regression, Log-binomial|||Power was not calculated for all secondary outcomes.||1.24|0.94|0.304
70959089|NCT01691768|141422106|SUPERIORITY|||||||0.455|||||||t-test, 2 sided|||||||0.455
70959090|NCT01691768|141422108|SUPERIORITY||incidence rate ratio|0.33||||0.097|TWO_SIDED|95.0|0.06|1.32|||z-test||We calculated incidence rate ratio, where the HPV incidence rate for the intervention arm represents the numerator and the HPV incidence rate for the control arm represents the denominator.|||1.32|0.06|0.097
70959091|NCT01691768|141422109|SUPERIORITY||Risk Ratio (RR)|0.91||||0.462|TWO_SIDED|95.0|0.7|1.18|||Regression, Log-binomial|||||1.18|0.70|0.462
70959092|NCT00819390|141422131|SUPERIORITY_OR_OTHER|||||||0.428||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05.|Wilcoxon (Mann-Whitney)|No other adjustments||Null hypothesis: There is no difference between the two arms/groups with respect to change in percent CD8 HLA-DR+/CD38+ from baseline to week 12.||||0.428
70959093|NCT00819390|141422131|SUPERIORITY_OR_OTHER|||||||0.247||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05.|Wilcoxon (Mann-Whitney)|No other adjustments.||Null hypothesis: There is no difference between the two arms/groups with respect to change in percent CD8 HLA-DR+/CD38+ from baseline to week 12.||||0.247
70959094|NCT01191268|141422169|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 95% Confidence Interval (CI) of 1.5 mg LY2189265 versus Insulin Glargine was below 0.4%, 1.5 mg LY2189265 was declared non-inferior to Insulin Glargine.|LS Mean Difference|-0.22|||<|0.001|TWO_SIDED|95.0|-0.38|-0.07||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||The study was designed to enroll 837 randomized participants (279 per treatment arm) with 90% power to detect non-inferiority of 1.5 mg LY2189265 versus Insulin Glargine on HbA1c change from baseline at the 26-week primary endpoint with a margin of 0.4%, a standard deviation of 1.3%, and a 1-sided alpha of 0.025 assuming no true difference between treatments. This corresponds to 248 participants per arm, with an assumed drop-out rate of 11%.||-0.07|-0.38|<0.001
70959095|NCT01191268|141422169|NON_INFERIORITY_OR_EQUIVALENCE|If the 1-sided adjusted p-value was below 0.025, then 0.75 mg LY2189265 was declared non-inferior to Insulin Glargine.|LS Mean Difference|-0.17|||<|0.001|TWO_SIDED|95.0|-0.33|-0.02||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||||-0.02|-0.33|<0.001
70879206|NCT02337907|141243678|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.057||0.9512|TWO_SIDED|95.0|-0.116|0.109||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.||0.109|-0.116|0.9512
70879207|NCT02337907|141243678|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.056||0.9321|TWO_SIDED|95.0|-0.105|0.115||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.||0.115|-0.105|0.9321
70879208|NCT02337907|141243678|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.057||0.1288|TWO_SIDED|95.0|-0.199|0.025||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.||0.025|-0.199|0.1288
70879209|NCT02337907|141243678|SUPERIORITY|H1-0: Mean NTB response of pooled doses of 10 mg QD, 25 mg QD, 25 mg BID and 50 mg QD = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.041||0.6492|TWO_SIDED|95.0|-0.098|0.061||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.||0.061|-0.098|0.6492
70879210|NCT02337907|141243679|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|1.066||0.5287|TWO_SIDED|95.0|-1.43|2.77||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||2.77|-1.43|0.5287
70879211|NCT02337907|141243679|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|1.099||0.7105|TWO_SIDED|95.0|-2.57|1.76||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||1.76|-2.57|0.7105
70879212|NCT02337907|141243679|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|1.064||0.3822|TWO_SIDED|95.0|-1.16|3.03||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||3.03|-1.16|0.3822
70959096|NCT01191268|141422169|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22||||0.005|TWO_SIDED|95.0|-0.38|-0.07||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||Superiority analysis.||-0.07|-0.38|0.005
70959097|NCT01191268|141422169|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17||||0.015|TWO_SIDED|95.0|-0.33|-0.02||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||Superiority analysis.||-0.02|-0.33|0.015
70959098|NCT01191268|141422170|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 95% Confidence Interval (CI) of 1.5 mg LY2189265 versus Insulin Glargine was below 0.4%, 1.5 mg LY2189265 was declared non-inferior to Insulin Glargine.|LS Mean Difference|-0.25|||<|0.001|TWO_SIDED|95.0|-0.42|-0.07||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||||-0.07|-0.42|<0.001
70959099|NCT01191268|141422170|NON_INFERIORITY_OR_EQUIVALENCE|If the 1-sided adjusted p-value was below 0.025, then 0.75 mg LY2189265 was declared non-inferior to Insulin Glargine.|LS Mean Difference|-0.19|||<|0.001|TWO_SIDED|95.0|-0.37|-0.02||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||||-0.02|-0.37|<0.001
70959100|NCT01191268|141422170|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25||||0.005|TWO_SIDED|95.0|-0.42|-0.07||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||Superiority analysis.||-0.07|-0.42|0.005
70959101|NCT01191268|141422170|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.014|TWO_SIDED|95.0|-0.37|-0.02||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||Superiority analysis.||-0.02|-0.37|0.014
70959102|NCT01191268|141422171|SUPERIORITY_OR_OTHER|||||||0.014||||||Treatment comparison for HbA1c less than 7.0% at 26 weeks.|Regression, Logistic|||||||0.014
70959103|NCT01191268|141422171|SUPERIORITY_OR_OTHER|||||||0.01||||||Treatment comparison for HbA1c less than 7.0% at 26 weeks.|Regression, Logistic|||||||0.010
70959104|NCT01191268|141422171|SUPERIORITY_OR_OTHER|||||||0.027||||||Treatment comparison for HbA1c less than or equal to 6.5% at 26 weeks.|Regression, Logistic|||||||0.027
70959105|NCT01191268|141422171|SUPERIORITY_OR_OTHER|||||||0.384||||||Treatment comparison for HbA1c less than or equal to 6.5% at 26 weeks.|Regression, Logistic|||||||0.384
70959106|NCT01191268|141422171|SUPERIORITY_OR_OTHER||||||<|0.05||||||Treatment comparison for HbA1c less than 7% at 52 weeks.|Regression, Logistic|||||||<0.05
70959107|NCT01191268|141422171|SUPERIORITY_OR_OTHER|||||||0.25||||||Treatment comparison for HbA1c less than 7% at 52 weeks.|Regression, Logistic|||||||0.250
70959108|NCT01191268|141422171|SUPERIORITY_OR_OTHER|||||||0.272||||||Treatment comparison for HbA1c less than or equal to 6.5% at 52 weeks.|Regression, Logistic|||||||0.272
70959109|NCT01191268|141422171|SUPERIORITY_OR_OTHER|||||||0.623||||||Treatment comparison for HbA1c less than or equal to 6.5% at 52 weeks.|Regression, Logistic|||||||0.623
70959110|NCT01191268|141422172|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 26 weeks.|Regression, Logistic|||||||<0.001
70959111|NCT01191268|141422172|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 26 weeks.|Regression, Logistic|||||||<0.001
70959112|NCT01191268|141422172|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 52 weeks.|Regression, Logistic|||||||<0.001
70959113|NCT01191268|141422172|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 52 weeks.|Regression, Logistic|||||||<0.001
70879213|NCT02337907|141243679|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|1.066||0.6472|TWO_SIDED|95.0|-2.59|1.61||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||1.61|-2.59|0.6472
70879214|NCT02337907|141243680|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.28||0.7551|TWO_SIDED|95.0|-0.46|0.64||p-value was nominal and not adjusted.|Mixed-effects Model for Repeated Measure|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.64|-0.46|0.7551
70879215|NCT02337907|141243680|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.28||0.3643|TWO_SIDED|95.0|-0.29|0.8||p-value was nominal and not adjusted.|Mixed-effects Model for Repeated Measure|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.80|-0.29|0.3643
70879216|NCT02337907|141243680|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.27||0.7822|TWO_SIDED|95.0|-0.45|0.6||p-value was nominal and not adjusted.|Mixed-effects Model for Repeated Measure|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.60|-0.45|0.7822
70879217|NCT02337907|141243680|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.28||0.6889|TWO_SIDED|95.0|-0.43|0.65||p-value was nominal and not adjusted.|Mixed-effects Model for Repeated Measure|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.65|-0.43|0.6889
70879218|NCT02337907|141243681|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|1.32|STANDARD_ERROR_OF_MEAN|0.933||0.1595|TWO_SIDED|95.0|-0.52|3.15||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||3.15|-0.52|0.1595
70879219|NCT02337907|141243681|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|0.962||0.2455|TWO_SIDED|95.0|-0.77|3.01||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||3.01|-0.77|0.2455
70879220|NCT02337907|141243681|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|1.28|STANDARD_ERROR_OF_MEAN|0.94||0.1732|TWO_SIDED|95.0|-0.57|3.13||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||3.13|-0.57|0.1732
70879221|NCT02337907|141243681|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|2.47|STANDARD_ERROR_OF_MEAN|0.936||0.0088|TWO_SIDED|95.0|0.63|4.31||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||4.31|0.63|0.0088
70959114|NCT01191268|141422173|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.628|TWO_SIDED|95.0|-0.35|0.21||Treatment comparison of Daily Mean values at 26 weeks.|Mixed Models Analysis|||||0.21|-0.35|0.628
70959115|NCT01191268|141422173|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.368|TWO_SIDED|95.0|-0.15|0.41||Treatment comparison of Daily Mean values at 26 weeks.|Mixed Models Analysis|||||0.41|-0.15|0.368
70959116|NCT01191268|141422173|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.37|TWO_SIDED|95.0|-0.16|0.42||Treatment comparison of Daily Mean values at 52 weeks.|Mixed Models Analysis|||||0.42|-0.16|0.370
70959117|NCT01191268|141422173|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.879|TWO_SIDED|95.0|-0.26|0.3||Treatment comparison of Daily Mean values at 52 weeks.|Mixed Models Analysis|||||0.30|-0.26|0.879
70959118|NCT01191268|141422174|SUPERIORITY_OR_OTHER||LS Mean Difference|1.31|||<|0.001|TWO_SIDED|95.0|0.83|1.79||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||1.79|0.83|<0.001
70959119|NCT01191268|141422174|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8|||<|0.001|TWO_SIDED|95.0|1.32|2.28||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||2.28|1.32|<0.001
70959120|NCT01191268|141422174|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|||<|0.001|TWO_SIDED|95.0|0.55|1.64||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||1.64|0.55|<0.001
70959121|NCT01191268|141422174|SUPERIORITY_OR_OTHER||LS Mean Difference|1.42|||<|0.001|TWO_SIDED|95.0|0.88|1.96||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||1.96|0.88|<0.001
70959122|NCT01191268|141422176|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.2|||<|0.001|TWO_SIDED|95.0|-3.81|-2.59||Treatment comparison at 26 weeks.|ANCOVA|||||-2.59|-3.81|<0.001
70879222|NCT02876900|141243682|SUPERIORITY|Assuming an effect size of 0.35 on the change in PANSS total score from baseline to Week 6 for the 2 pairwise comparisons between each active asenapine maleate transdermal patch treatment arm and placebo, the power for detecting a statistically significant HP-3070 advantage was approximately 0.90, having 204 evaluable participants per each treatment arm using a 2-sided alpha level of 0.025 for each comparison.|Least Square Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|1.634||0.003|TWO_SIDED|95.0|-8.06|-1.64||Adjusted p-value was calculated according to the truncated Hochberg procedure with a truncation factor y=0.9. Adjustment for multiple comparisons uses a parallel gatekeeping procedure.|Mixed Model Repeated Measures Analysis|||The mixed model for repeated measures includes treatment, country, visit, treatment by visit interaction, and baseline value as covariates, and participant as random effect. The correlation of repeated measures within a participant is estimated with an unstructured covariance matrix. The Kenward-Rogers method is used to estimate the denominator degrees of freedom.||-1.64|-8.06|0.003
70879223|NCT02876900|141243682|SUPERIORITY|Assuming an effect size of 0.35 on the change in PANSS total score from baseline to Week 6 for the 2 pairwise comparisons between each active asenapine maleate transdermal patch treatment arm and placebo, the power for detecting a statistically significant HP-3070 advantage was approximately 0.90, having 204 evaluable participants per each treatment arm using a 2-sided alpha level of 0.025 for each comparison.|Least Square Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|1.63|<|0.001|TWO_SIDED|95.0|-9.81|-3.4||Adjusted p-value was calculated according to the truncated Hochberg procedure with a truncation factor y=0.9. Adjustment for multiple comparisons uses a parallel gatekeeping procedure.|Mixed Model Repeated Measures Analysis|||The mixed model for repeated measures includes treatment, country, visit, treatment by visit interaction, and baseline value as covariates, and participant as random effect. The correlation of repeated measures within a participant is estimated with an unstructured covariance matrix. The Kenward-Rogers method is used to estimate the denominator degrees of freedom.||-3.4|-9.81|<0.001
70879224|NCT02876900|141243683|SUPERIORITY||Least Square Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.55|-0.16||Adjusted p-value was calculated according to the Hochberg procedure. Adjustment for multiple comparisons uses a parallel gatekeeping procedure.|Mixed Model Repeated Measures Analysis|||The mixed model for repeated measures includes treatment, country, visit, treatment by visit interaction, and baseline value as covariates, and participant as random effect. The correlation of repeated measures within a participant is estimated with an unstructured covariance matrix. The Kenward-Rogers method is used to estimate the denominator degrees of freedom.||-0.16|-0.55|<0.001
70879225|NCT02876900|141243683|SUPERIORITY||Least Square Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.64|-0.25||Adjusted p-value was calculated according to the Hochberg procedure. Adjustment for multiple comparisons uses a parallel gatekeeping procedure.|Mixed Model Repeated Measures Analysis|||The mixed model for repeated measures includes treatment, country, visit, treatment by visit interaction, and baseline value as covariates, and participant as random effect. The correlation of repeated measures within a participant is estimated with an unstructured covariance matrix. The Kenward-Rogers method is used to estimate the denominator degrees of freedom.||-0.25|-0.64|<0.001
70879226|NCT01592344|141243684|SUPERIORITY_OR_OTHER|||||||0.0048|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0048
70879227|NCT01592344|141243685|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
70879228|NCT01592344|141243686|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
70879229|NCT01592344|141243687|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
70879230|NCT00720057|141243694|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||The treatment differences between the two groups were tested each at the 5% two-sided significant level using a hierarchal testing procedure to control the overall type 1 error. SPID16-24 was eligible for testing only after a statistically significant difference between the two arms with respect to SPID0-24 was observed. The SPIDs were analyzed via ANCOVA model with treatment and trial site as fixed effects and baseline pain intensity score as the covariate.||||<0.001
70879231|NCT00720057|141243695|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
70879232|NCT00720057|141243696|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
70879233|NCT00720057|141243697|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||The statistics are from the Kaplan-Meier method. The median for naproxen treatment arm was not estimable from Kaplan-Meier method, therefore it is presented as the maximum value from the full range.||||<0.001
70879234|NCT00720057|141243698|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
70879235|NCT00720057|141243699|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Log Rank|||||||<0.001
70879236|NCT00525733|141243720|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Chi-squared|||||||0.46
70879237|NCT00391274|141243741|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.1326||95.0|0.76|8.25||Logistic regression of best overall tumor response (complete response + partial response).|Regression, Logistic|Treatment was the only covariate.||||8.25|0.76|0.1326
70879238|NCT00391274|141243742|SUPERIORITY_OR_OTHER|||||||0.7704||95.0|||||Log Rank|||||||0.7704
70879239|NCT00391274|141243742|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.7784||95.0|0.75|1.46|||Regression, Cox|Treatment was the only covariate.||||1.46|0.75|0.7784
70879240|NCT00391274|141243745|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.4921||95.0|0.78|1.68||P-value for Overall Survival (up to 24 months)|Regression, Cox|Treatment was the only covariate.||||1.68|0.78|0.4921
70879241|NCT00391274|141243745|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.9256|TWO_SIDED|95.0|0.74|1.4||P-value for Overall Survival (up to 30 months)|Regression, Cox|||||1.40|0.74|0.9256
70879242|NCT03341533|141243747|EQUIVALENCE|The null hypothesis is that there is no difference in NPIS between the two groups.|difference in medians|0.0||||0.39|TWO_SIDED||||||Kruskal-Wallis|||||||0.39
70879243|NCT03341533|141243748|EQUIVALENCE|The null hypothesis is that there is no difference in MME use on the hospital floor between groups.|Difference of medians|-4.5||||0.88|TWO_SIDED||||||Kruskal-Wallis||Ice packs - Usual care|||||0.88
70879244|NCT03341533|141243749|EQUIVALENCE|The null hypothesis is that the outpatient MME consumption will be the same across the two groups.|difference in medians|-7.5||||0.75|TWO_SIDED||||||Kruskal-Wallis||Ice packs - Usual Care|||||0.75
70879245|NCT03341533|141243750|EQUIVALENCE|The null hypothesis is that the postoperative BPI pain severity score will be the same between groups|difference in medians|-0.3||||0.8|TWO_SIDED||||||Kruskal-Wallis||Ice Packs - Usual Care|||||0.80
70879246|NCT03559257|141243780|SUPERIORITY||LSMean Difference|-3.12|STANDARD_ERROR_OF_MEAN|0.41|<|0.0001|TWO_SIDED|95.0|-3.92|-2.32|||Mixed Models Analysis|||||-2.32|-3.92|<0.0001
70879247|NCT03559257|141243781|SUPERIORITY||LSMean Difference|-2.57|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-3.41|-1.72|||Mixed Models Analysis|||||-1.72|-3.41|<0.0001
70879248|NCT03559257|141243782|SUPERIORITY||Odds Ratio (OR)|3.935|||<|0.0001|TWO_SIDED|95.0|2.719|5.693|||pseudo likelihood-based repeated measure|||||5.693|2.719|<0.0001
70879249|NCT03559257|141243783|SUPERIORITY||Odds Ratio (OR)|3.481|||<|0.0001|TWO_SIDED|95.0|2.252|5.381|||Pseudo likelihood-based repeated measure|||||5.381|2.252|<0.0001
70959123|NCT01191268|141422176|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.15|||<|0.001|TWO_SIDED|95.0|-2.76|-1.54||Treatment comparison at 26 weeks.|ANCOVA|||||-1.54|-2.76|<0.001
70879250|NCT03559257|141243784|SUPERIORITY||LSMean Difference|12.53|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|TWO_SIDED|95.0|9.19|15.87|||Mixed Models Analysis|||||15.87|9.19|<0.0001
70879251|NCT03559257|141243785|SUPERIORITY||LSMean Difference|11.51|STANDARD_ERROR_OF_MEAN|2.22|<|0.0001|TWO_SIDED|95.0|7.14|15.89|||Mixed Models Analysis|||||15.89|7.14|<0.0001
70879252|NCT03559257|141243786|SUPERIORITY||Odds Ratio (OR)|5.878||||0.0001|TWO_SIDED|95.0|2.374|14.554|||Pseudo likelihood-based repeated measure|||||14.554|2.374|0.0001
70879253|NCT03559257|141243787|SUPERIORITY||Odds Ratio (OR)|999.999|||<|0.0001|TWO_SIDED|95.0|548.706|999.999|||Pseudo likelihood-based repeated measure||Estimated value and upper bound are \>999.999|||999.999|548.706|<0.0001
70879254|NCT03559257|141243788|SUPERIORITY||Odds Ratio (OR)|5.012|||<|0.0001|TWO_SIDED|95.0|2.352|10.679|||pseudo likelihood-based repeated measure|||||10.679|2.352|<0.0001
70879255|NCT03559257|141243789|SUPERIORITY||Odds Ratio (OR)|999.99|||<|0.0001|TWO_SIDED|95.0|999.99|999.99|||Pseudo likelihood-based repeated measure||Point estimate, upper limit and lower limit are \>999.99|||999.99|999.99|<0.0001
70879256|NCT03559257|141243790|SUPERIORITY||LSMean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.38|<|0.0001|TWO_SIDED|95.0|-4.14|-2.65|||Mixed Models Analysis|||||-2.65|-4.14|<0.0001
70879257|NCT03559257|141243791|SUPERIORITY||LSMean Difference|-3.13|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-3.96|-2.29|||Mixed Models Analysis|||||-2.29|-3.96|<0.0001
70879258|NCT03559257|141243792|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70879259|NCT03559257|141243793|SUPERIORITY||LSMean Difference|-1.06|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-1.58|-0.54|||Mixed Models Analysis|||||-0.54|-1.58|<0.0001
70879260|NCT03559257|141243794|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Activity Impairment.||||<0.0001
70879261|NCT03559257|141243794|SUPERIORITY|||||||0.388|||||||ANCOVA|||Absenteeism.||||0.3880
70879262|NCT03559257|141243794|SUPERIORITY|||||||0.0004|||||||ANCOVA|||Presenteeism.||||0.0004
70879263|NCT03559257|141243794|SUPERIORITY|||||||0.0003|||||||ANCOVA|||Work impairment.||||0.0003
70879264|NCT03559257|141243795|SUPERIORITY|||||||0.0003|||||||ANCOVA|||||||0.0003
70879265|NCT03559257|141243796|SUPERIORITY|||||||0.1267|||||||ANCOVA|||||||0.1267
70879266|NCT03559257|141243797|SUPERIORITY|||||||0.163|||||||ANCOVA|||||||0.1630
70879267|NCT03559257|141243798|SUPERIORITY|||||||0.0277|||||||ANCOVA|||||||0.0277
70879268|NCT01519960|141243805|OTHER||Odds Ratio (OR)|5.43|||=|0.0043|TWO_SIDED|95.0|1.54|19.2|||Cochran-Mantel-Haenszel|||Analysis stratified by hepatitis B virus (HBV) genotype A versus non-A genotypes and alanine aminotransferase (ALT) less than (\<) 5 times (×) upper limit of normal (ULN) versus greater than or equal to (≥) 5 × ULN at Baseline. The OR was calculated using Group B as reference.||19.2|1.54|= 0.0043
70879269|NCT01519960|141243805|OTHER||||||=|0.3732|||||||Breslow-Day|||||||= 0.3732
70879270|NCT01387347|141243878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.2596|||||||t-test, 2 sided|||Inferior corneal fluorescein staining score at Day 29(primary sign) was summarized using descriptive statistics (number of observations, mean, standard deviation, median, minimum, and maximum). Active treatment was compared to placebo using a two-sample t-test assuming unequal variances, assessed at the α = 0.05 level||||0.2596
70879271|NCT01387347|141243878|SUPERIORITY_OR_OTHER|||||||0.0075|TWO_SIDED||||||t-test, 2 sided|||Comparison of central corneal fluorescein staining score between the placebo and Thymosin beta 4 groups||||0.0075
70879272|NCT01387347|141243878|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||t-test, 2 sided|||Comparison of superior corneal fluorescein staining score between the placebo and Thymosin beta 4 groups||||0.0210
70879273|NCT01387347|141243879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.3734|TWO_SIDED||||||t-test, 2 sided|||Comparison between the groups uses a two-sample t-test assuming unequal variances, assessed at the alpha = 0.05 level.||||0.3734
70879274|NCT01387347|141243879|SUPERIORITY_OR_OTHER|||||||0.0244|TWO_SIDED||||||t-test, 2 sided|||Comparison of discomfort score between the placebo and Thymosin beta 4 groups on Day 28||||0.0244
70879275|NCT00561080|141243911|NON_INFERIORITY_OR_EQUIVALENCE|Superiority was achieved if the lower bound of the 2-sided 95% CI of the GMT ratio was greater than 1.2|Geometric Mean Titer Ratio (GMTR)|1.11||||0.948|TWO_SIDED|95.0|1.02|1.22|||ANOVA||GMTR = GMT Post Dose 2/GMT Post dose 1|||1.22|1.02|0.948
70879276|NCT00561080|141243911|NON_INFERIORITY_OR_EQUIVALENCE|Superiority was achieved if the lower bound of the 2-sided 95% CI of the GMT ratio was greater than 1.2|GMTR|0.78|||>|0.999|TWO_SIDED|95.0|0.73|0.85|||ANOVA||GMTR = GMT Post Dose 2/GMT Post dose 1|||0.85|0.73|>0.999
70879277|NCT00561080|141243912|SUPERIORITY_OR_OTHER||GMFR|2.35|||||TWO_SIDED|95.0|2.11|2.62|||||GMFR=GMT Post Dose/GMT Pre Dose|||2.62|2.11|
70879278|NCT00561080|141243914|SUPERIORITY_OR_OTHER||GMT Ratio|1.06|||||TWO_SIDED|95.0|0.96|1.17|||||GMT Ratio = Group 2 GMT/Group 1 GMT|ANCOVA model includes country and age at first vaccination as independent variables and baseline antibody titre as covariate. The GMT 12-month post-last dose is the GMT adjusted from the ANCOVA model||1.17|0.96|
70879279|NCT00561080|141243914|SUPERIORITY_OR_OTHER||GMT Ratio|1.08|||||TWO_SIDED|95.0|0.98|1.19|||||GMT Ratio = GMT Group 3/GMT Group 1|ANCOVA model includes country and age at first vaccination as independent variables and baseline antibody titre as covariate. The GMT 12-month post-last dose is the GMT adjusted from the ANCOVA model||1.19|0.98|
70959124|NCT01191268|141422176|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.23|||<|0.001|TWO_SIDED|95.0|-3.99|-2.48||Treatment comparison at 52 weeks.|ANCOVA|||||-2.48|-3.99|<0.001
70959125|NCT01191268|141422176|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.03|||<|0.001|TWO_SIDED|95.0|-2.78|-1.27||Treatment comparison at 52 weeks.|ANCOVA|||||-1.27|-2.78|<0.001
70959126|NCT01191268|141422178|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.2|||<|0.001|TWO_SIDED|95.0|-1.44|-0.96||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||-0.96|-1.44|<0.001
70879280|NCT00827983|141243934|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis (H0) was tested against the alternative by calculating a two-sided 95% confidence interval for the difference in ongoing pregnancy rates. If the lower bound of the 95% confidence interval was greater than the non-inferiority limit (-10.0%), the null hypothesis was rejected and the test group considered not inferior to the control treatment.|Difference in pregnancy rates|-3.1||||0.37|TWO_SIDED|95.0|-9.9|3.7|||Chi-squared|||"The non -inferiority hypothesis to be tested for the primary endpoint was that the ongoing pregnancy rate (oPR) in the test group (Pe)was lower than the oPR in the control group (Pc)against the alternative one that the oPR in the test group was equal to or higher than the oPR in the control group.~H0 : Pc\>= Pe + d(-10%) H1 : Pc\< Pe + d(-10%)"||3.7|-9.9|0.37
70879281|NCT00827983|141243935|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.1||||0.37|TWO_SIDED|95.0|-9.87|3.68|||Chi-squared|||||3.68|-9.87|0.37
70879282|NCT00827983|141243936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|1.33||0.85|TWO_SIDED|95.0|-4.7|5.8|||t-test, 2 sided|||||5.8|-4.7|0.85
70879283|NCT01876485|141243943|SUPERIORITY||Mean Difference (Final Values)|0.43||||0.003|TWO_SIDED||||||proc mixed in SAS (multilevel modeling)|Numerator degrees of freedom = 1 for both models (4mo and 10mo) and denominator degrees of freedom vary based on multiple imputation.||"We compared group differences in HbA1c at 4. The value of HbA1c at 4 months was the dependent variable, treatment group was the independent variable, and baseline HbA1c was a covariate.~Power calculations were based on effect sizes for the HbA1c in similar trial that revealed small-to-medium effect sizes. Our goal was to include 130 patients in each arm. The randomized samples (n = 140 EPIC, n = 140 EUC) exceed the required 130 per group."||||0.003
70879284|NCT01876485|141243943|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.6|TWO_SIDED||||||proc mixed in SAS (multilevel modeling)|Numerator degrees of freedom = 1 for both models (4mo and 10mo) and denominator degrees of freedom vary based on multiple imputation.||"We compared group differences in HbA1c at 10 months. The value of HbA1c at 10 months was the dependent variable, treatment group was the independent variable, and baseline HbA1c was a covariate.~Power calculations were based on effect sizes for the HbA1c in similar trial that revealed small-to-medium effect sizes. Our goal was to include 130 patients in each arm. The randomized samples (n = 140 EPIC, n = 140 EUC) exceed the required 130 per group."||||.60
70879285|NCT01876485|141243944|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.003|TWO_SIDED||||||proc mixed in SAS (multilevel modeling)|||We compared group differences in DDS at 4 months. The value of DDS at 4 months was the dependent variable, treatment group was the independent variable, and baseline DDS was a covariate. Power calculations were based on effect sizes for the DDS in similar trial that revealed small-to-medium effect sizes. Our goal was to include 130 patients in each arm. The randomized samples (n=138 EPIC, n=135 EUC) exceed the required 130 per group.||||0.003
70879286|NCT01876485|141243944|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.003|TWO_SIDED||||||proc mixed in SAS (multilevel modeling)|||We compared group differences in DDS at 10 months. The value of DDS at 10 months was the dependent variable, treatment group was the independent variable, and baseline DDS was a covariate. Power calculations were based on effect sizes for the DDS in similar trial that revealed small-to-medium effect sizes. Our goal was to include 130 patients in each arm. The randomized samples (n=138 EPIC, n=135 EUC) exceed the required 130 per group.||||.003
70879287|NCT02446990|141243945|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.08|STANDARD_ERROR_OF_MEAN|0.06||0.1969|TWO_SIDED|95.0|0.96|1.2|||Regression, Cox|||||1.2|0.96|0.1969
70959127|NCT01191268|141422178|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.79|||<|0.001|TWO_SIDED|95.0|-1.03|-0.55||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||-0.55|-1.03|<0.001
70959128|NCT01191268|141422178|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.24|||<|0.001|TWO_SIDED|95.0|-1.55|-0.94||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||-0.94|-1.55|<0.001
70879288|NCT02446990|141243946|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.06|STANDARD_ERROR_OF_MEAN|0.07||0.3461|TWO_SIDED|95.0|0.94|1.21|||Regression, Cox|||||1.21|0.94|0.3461
70879289|NCT02446990|141243947|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.1|STANDARD_ERROR_OF_MEAN|0.09||0.2493|TWO_SIDED|95.0|0.94|1.28|||Regression, Cox|||||1.28|0.94|0.2493
70879290|NCT02446990|141243948|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.06|STANDARD_ERROR_OF_MEAN|0.09||0.5162|TWO_SIDED|95.0|0.89|1.26|||Regression, Cox|||||1.26|0.89|0.5162
70879291|NCT02446990|141243949|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.35|STANDARD_ERROR_OF_MEAN|0.29||0.1647|TWO_SIDED|95.0|0.88|2.05|||Regression, Cox|||||2.05|0.88|0.1647
70879292|NCT02446990|141243950|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.04|STANDARD_ERROR_OF_MEAN|0.08||0.6024|TWO_SIDED|95.0|0.9|1.21|||Regression, Cox|||||1.21|0.90|0.6024
70879293|NCT02446990|141243951|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.89||||0.1458|TWO_SIDED|95.0|0.75|1.04|||Regression, Cox|||||1.04|0.75|0.1458
70879294|NCT02446990|141243952|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.0||||0.979|TWO_SIDED|95.0|0.89|1.12|||Regression, Cox|||||1.12|0.89|0.9790
70879295|NCT02446990|141243953|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.06||||0.4299|TWO_SIDED|95.0|0.92|1.22|||Regression, Cox|||||1.22|0.92|0.4299
70879296|NCT02446990|141243954|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.97||||0.5916|TWO_SIDED|95.0|0.88|1.08|||Regression, Cox|||||1.08|0.88|0.5916
70879297|NCT02446990|141243955|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.98||||0.6963|TWO_SIDED|95.0|0.89|1.08|||Regression, Cox|||||1.08|0.89|0.6963
70879298|NCT02446990|141243956|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.06||||0.2222|TWO_SIDED|95.0|0.96|1.18|||Regression, Cox|||||1.18|0.96|0.2222
70879299|NCT02446990|141243957|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.05||||0.3671|TWO_SIDED|95.0|0.94|1.18|||Regression, Cox|||||1.18|0.94|0.3671
70879300|NCT02446990|141243958|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.97||||0.5285|TWO_SIDED|95.0|0.87|1.07|||Regression, Cox|||||1.07|0.87|0.5285
70959129|NCT01191268|141422178|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.76|||<|0.001|TWO_SIDED|95.0|-1.06|-0.46||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||-0.46|-1.06|<0.001
70959130|NCT01270971|141422200|SUPERIORITY_OR_OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
70959131|NCT01270971|141422201|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70959132|NCT01270971|141422202|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70959133|NCT01270971|141422203|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70959134|NCT02411357|141422204|SUPERIORITY||||||<|0.001|||||||Cochran-Armitage Chi-square trend test|||||||<.001
70959135|NCT01588496|141422213|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-29.78|STANDARD_ERROR_OF_MEAN|5.54|<|0.001|TWO_SIDED|95.0|-40.94|-18.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, baseline LDL-C level (\< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-18.62|-40.94|<0.001
70959136|NCT01588496|141422214|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-23.14|STANDARD_ERROR_OF_MEAN|5.81|<|0.001|TWO_SIDED|95.0|-34.83|-11.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, baseline LDL-C level (\< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-11.45|-34.83|<0.001
70959137|NCT01588496|141422215|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-22.89|STANDARD_ERROR_OF_MEAN|5.38|<|0.001|TWO_SIDED|95.0|-33.72|-12.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, baseline LDL-C level (\< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-12.05|-33.72|<0.001
70959138|NCT01588496|141422216|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-11.83|STANDARD_ERROR_OF_MEAN|6.77||0.088|TWO_SIDED|95.0|-25.48|1.82||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, baseline LDL-C level (\< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||1.82|-25.48|0.088
70959139|NCT01588496|141422217|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-11.27|STANDARD_ERROR_OF_MEAN|5.86||0.088|TWO_SIDED|95.0|-23.11|0.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects|Model includes treatment group, baseline LDL-C level (\< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||0.56|-23.11|0.088
70959140|NCT01588496|141422218|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-30.93|STANDARD_ERROR_OF_MEAN|6.42|<|0.001|TWO_SIDED|95.0|-43.86|-18.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, baseline LDL-C level (\< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|LDL-C lowering was analyzed by comparing evolocumab and placebo. Statistical analysis was 2-sided with a significance level of 0.05.||-18.00|-43.86|<0.001
70959141|NCT00705523|141422259|SUPERIORITY_OR_OTHER|||||||0.1|||||||Regression, Logistic|beta=-0.67, exp(beta)=0.51, chi-squared(1) = 0.2.71||Self-reported drinking results, as gathered by the TLFB, were compared by the generalized estimating equations (GEE) (Diggle et al., 1994), using Poisson models for counts of drinking and heavy drinking days, and logistic regression models for absence/presence binary indicators of drinking. In the GEE model, the pre-treatment of the response was included as a covariate, together with the treatment group indicator, and a linear time effect.||||0.10
70959142|NCT03110185|141422284|OTHER|Correlation||||||0.0761||||||Delirium Incidence. There were no multiple comparisons, but includes age as a regressor. a priori threshold was p \< 0.05.|Regression, Logistic|Generalized logistic regression for delirium incidence and total DMN fc with age as a regressor.||||||0.0761
70959143|NCT00600886|141422285|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.942||||0.007|TWO_SIDED|95.0|1.19|3.168|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel adjusting for randomization stratification factor||Overall - All patients||3.168|1.190|0.007
70959144|NCT00600886|141422285|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.337|||||TWO_SIDED|95.0|1.14|4.79||||||Post surgery - patients with prior surgery but no previous medical treatment for acromegaly||4.790|1.140|
70959145|NCT00600886|141422285|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.654|||||TWO_SIDED|95.0|0.846|3.234||||||De novo - patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.||3.234|0.846|
70959146|NCT03319849|141422330|SUPERIORITY||Median Difference (Final Values)|-0.049|STANDARD_ERROR_OF_MEAN|0.0206||0.0186|TWO_SIDED|95.0|-0.089|-0.0082|||Mixed Models Analysis|||||-0.0082|-0.0890|0.0186
70959147|NCT01060540|141422333|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.44|TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|Adjusted for family history (low/unknown vs. high/moderate) and BMI\>=35 (yes vs no) stratification variables||||0.7|-0.3|0.44
70959148|NCT01060540|141422334|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.19|TWO_SIDED|95.0|-0.1|0.3||adjusted for baseline BMI class and family history level stratification variables|Mixed Models Analysis|||||0.3|-0.1|0.19
70959149|NCT01060540|141422335|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.38|TWO_SIDED|95.0|-0.4|0.1||adjusted for stratification variables baseline BMI and family history|Mixed Models Analysis|||||0.1|-0.4|0.38
70879301|NCT02738151|141243985|NON_INFERIORITY|Non-inferiority of Toujeo vs Tresiba was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for the difference between groups was \<0.3%.|Least Square (LS) Mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001|TWO_SIDED|95.0|-0.152|0.051||Threshold for significance at 0.025 level.|Mixed Models Analysis||Toujeo vs. Tresiba|A hierarchical step-down testing procedure was used to control type 1 error. Analysis was performed using a MMRM approach with treatment groups, randomization strata, visit, and treatment-by-visit interaction as fixed categorical effects and baseline HbA1c value and baseline HbA1c value-by-visit interaction as continuous fixed covariates.||0.051|-0.152|<.0001
70879302|NCT02738151|141243985|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.052||0.3302|TWO_SIDED|95.0|-0.152|0.051|||Mixed Models Analysis|||Superiority of Toujeo over Tresiba was demonstrated if the upper bound of the two-sided 95% CI for the difference in the mean change in HbA1c from baseline to Week 24 between Toujeo over Tresiba on ITT population was \<0 (zero).||0.051|-0.152|0.3302
70879303|NCT03649711|141244006|OTHER|Post treatment values were compared using ANCOVA||||||0.002|||||||ANCOVA|||||||0.002
70879304|NCT03649711|141244006|OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||mean changes in values were compared by Wilcoxon rank sum test adjusted for multiple comparisons (Bonferonni method) between CKD-ticagrelor arm, and the non-CKD controls||||0.18
70879305|NCT03649711|141244007|OTHER|||||||0.22|||||||ANCOVA|||CKD groups randomized were compared for post treatment values.||||0.22
70879306|NCT02016625|141244017|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis (H0): ratio is outside of interval (80%, 125%) vs. alternative hypothesis (H1): ratio is inside of interval (80%, 125%)|gMean ratio (%)|108.2|STANDARD_ERROR_OF_MEAN|11.5||0.0033|TWO_SIDED|90.0|99.992|117.076|||ANOVA||ratio of cyclo + FDV to cyclo treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|Geometric mean (gMean) ratio of cyclo + FDV to cyclo treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||117.076|99.992|0.0033
70879307|NCT02016625|141244018|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) vs. H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|106.6|STANDARD_ERROR_OF_MEAN|11.7||0.0019|TWO_SIDED|90.0|98.36|115.534|||ANOVA||gMean ratio of cyclo+FDV to cyclo treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of cyclo+FDV to cyclo treatment The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||115.534|98.360|0.0019
70879308|NCT02016625|141244019|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|90.14|STANDARD_ERROR_OF_MEAN|16.6||0.0457|TWO_SIDED|90.0|80.281|101.205|||ANOVA||gMean ratio of cyclo+FDV to cyclo treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of cyclo+FDV to cyclo treatment The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||101.205|80.281|0.0457
70879309|NCT02016625|141244020|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|140.98|STANDARD_ERROR_OF_MEAN|35.8||0.8122|TWO_SIDED|90.0|111.772|177.833|||ANOVA||gMean ratio of cyclo+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of cyclo+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||177.833|111.772|0.8122
70879310|NCT02016625|141244021|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|116.92|STANDARD_ERROR_OF_MEAN|11.0||0.065|TWO_SIDED|90.0|108.674|125.801|||ANOVA||gMean ratio of cyclo+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of cyclo+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||125.801|108.674|0.0650
70879311|NCT02016625|141244022|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|122.68|STANDARD_ERROR_OF_MEAN|23.9||0.4181|TWO_SIDED|90.0|104.8|143.6|||ANOVA||gMean ratio of cyclo+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of cyclo+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||143.60|104.80|0.4181
70959150|NCT01060540|141422336|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.05|TWO_SIDED|95.0|-0.2|0.0||adjusted for baseline family history and BMI|Mixed Models Analysis|||||0.0|-0.2|0.05
70959151|NCT01060540|141422337|SUPERIORITY_OR_OTHER||incident rate ratio|0.9||||0.68|TWO_SIDED|95.0|0.7|1.2||adjusted for baseline family history and BMI|generalized linear model for count data|||||1.2|0.7|0.68
70959152|NCT02502097|141422338|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-2.5||||0.5096|TWO_SIDED|95.0|-10.1|5.1|||Mixed Models Analysis||LS mean difference Day 7|||5.1|-10.1|0.5096
70879312|NCT02016625|141244023|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|127.41|STANDARD_ERROR_OF_MEAN|16.8||0.6207|TWO_SIDED|90.0|114.453|141.827|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||141.827|114.453|0.6207
70959153|NCT02502097|141422338|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-0.8||||0.8983|TWO_SIDED|95.0|-13.4|11.8|||Mixed Models Analysis||LS mean difference Day 14|||11.8|-13.4|0.8983
70959154|NCT02502097|141422342|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-3.7||||0.5005|TWO_SIDED|95.0|-14.6|7.2|||Mixed Models Analysis||LS means difference Day 7|||7.2|-14.6|0.5005
70959155|NCT02502097|141422342|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-1.8||||0.8382|TWO_SIDED|95.0|-19.8|16.1|||Mixed Models Analysis||LS means difference Day 14|||16.1|-19.8|0.8382
70879313|NCT02016625|141244024|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|136.85|STANDARD_ERROR_OF_MEAN|22.4||0.8592|TWO_SIDED|90.0|118.683|157.793|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||157.793|118.683|0.8592
70879314|NCT02016625|141244025|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|99.15|STANDARD_ERROR_OF_MEAN|28.5||0.0269|TWO_SIDED|90.0|82.857|118.644|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||118.644|82.857|0.0269
70879315|NCT02016625|141244026|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|93.85|STANDARD_ERROR_OF_MEAN|25.1||0.0493|TWO_SIDED|90.0|80.059|110.022|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||110.022|80.059|0.0493
70879316|NCT02016625|141244027|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|99.54|STANDARD_ERROR_OF_MEAN|10.0||0|TWO_SIDED|90.0|93.375|106.115|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||106.115|93.375|0.0000
70879317|NCT02016625|141244028|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|96.16|STANDARD_ERROR_OF_MEAN|12.9||0.0008|TWO_SIDED|90.0|88.53|104.45|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||104.45|88.53|0.0008
70879318|NCT00380978|141244032|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence|Risk Ratio (RR)|1.04||||0.65|TWO_SIDED|95.0|0.9|1.2|||Chi-squared, Corrected|||Group sample sizes of 800 in each group achieve 80% power to detect equivalence when the margin of equivalence extends from 0.1 to 0.25||1.20|0.90|0.65
70879319|NCT00380978|141244033|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98||||0.63|TWO_SIDED|95.0|0.8|1.2|||Chi-squared|||There rate of instrumented vaginal delivery will be equal in both groups.||1.20|0.80|0.63
70879320|NCT00380978|141244034|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Log Rank|||||||0.047
70879321|NCT00380978|141244035|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||Chi-squared|||||||0.35
70959156|NCT02502097|141422343|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-1.3||||0.8008|TWO_SIDED|95.0|-11.9|9.2|||Mixed Models Analysis||LS means difference Day 7|||9.2|-11.9|0.8008
70959157|NCT02502097|141422343|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|0.2||||0.9805|TWO_SIDED|95.0|-17.6|18.0|||Mixed Models Analysis||LS means difference Day 14|||18.0|-17.6|0.9805
70959158|NCT02502097|141422346|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-2.4||||0.3279|TWO_SIDED|95.0|-7.1|2.4|||Mixed Models Analysis||LS means difference Day 7|||2.4|-7.1|0.3279
70959159|NCT02502097|141422346|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|1.5||||0.7772|TWO_SIDED|95.0|-9.2|12.3|||Mixed Models Analysis||LS means difference Day 14|||12.3|-9.2|0.7772
70959160|NCT02502097|141422347|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-3.2||||0.3493|TWO_SIDED|95.0|-10.1|3.6|||Mixed Models Analysis||LS means difference Day 7|||3.6|-10.1|0.3493
70959161|NCT02502097|141422347|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|1.0||||0.8952|TWO_SIDED|95.0|-14.3|16.3|||Mixed Models Analysis||LS means difference Day 14|||16.3|-14.3|0.8952
70959162|NCT02502097|141422348|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-1.5||||0.6597|TWO_SIDED|95.0|-8.1|5.2|||Mixed Models Analysis||LS means difference Day 7|||5.2|-8.1|0.6597
70959163|NCT02502097|141422348|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|2.1||||0.788|TWO_SIDED|95.0|-13.1|17.2|||Mixed Models Analysis||LS means difference Day 14|||17.2|-13.1|0.7880
70959164|NCT02502097|141422352|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-2.5||||0.1856|TWO_SIDED|95.0|-6.3|1.3|||Mixed Models Analysis||LS mean difference Day 7|||1.3|-6.3|0.1856
70959165|NCT02502097|141422352|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|2.7||||0.5658|TWO_SIDED|95.0|-6.6|12.1|||Mixed Models Analysis||LS mean difference Day 14|||12.1|-6.6|0.5658
70959166|NCT02502097|141422353|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-8.0||||0.0847|TWO_SIDED|95.0|-17.2|1.1|||Mixed Models Analysis||LS mean difference Day 7|||1.1|-17.2|0.0847
70959167|NCT02502097|141422353|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-5.8||||0.3083|TWO_SIDED|95.0|-17.0|5.4|||Mixed Models Analysis||LS mean difference Day 14|||5.4|-17.0|0.3083
70959168|NCT02502097|141422354|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-2.0||||0.229|TWO_SIDED|95.0|-5.3|1.3|||Mixed Models Analysis||LS mean difference Day 7|||1.3|-5.3|0.2290
70959169|NCT02502097|141422354|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|0.0||||0.9794|TWO_SIDED|95.0|-3.5|3.4|||Mixed Models Analysis||LS mean difference Day 14|||3.4|-3.5|0.9794
70959170|NCT02502097|141422355|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-1.0||||0.0009|TWO_SIDED|95.0|-1.5|-0.4|||Mixed Models Analysis||LS mean difference Week 1|||-0.4|-1.5|0.0009
70959171|NCT02502097|141422355|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-1.0||||0.005|TWO_SIDED|95.0|-1.7|-0.3|||Mixed Models Analysis||LS mean difference Week 2|||-0.3|-1.7|0.0050
70959172|NCT02502097|141422356|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-2.8||||0.2938|TWO_SIDED|95.0|-8.2|2.5|||Mixed Models Analysis||LS mean difference Day 7|||2.5|-8.2|0.2938
70959173|NCT02502097|141422356|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-4.0||||0.1319|TWO_SIDED|95.0|-9.2|1.2|||Mixed Models Analysis||LS mean difference Day 14|||1.2|-9.2|0.1319
70959174|NCT02502097|141422357|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.2175|TWO_SIDED|95.0|-1.5|0.4|||Mixed Models Analysis||LS mean difference Day 7|||0.4|-1.5|0.2175
70959175|NCT02502097|141422357|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.5312|TWO_SIDED|95.0|-1.4|0.7|||Mixed Models Analysis||LS mean difference Day 14|||0.7|-1.4|0.5312
70959176|NCT00252733|141422379|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.821||||0.0508|TWO_SIDED|95.0|0.673|1.001|||Log Rank|Generalized||||1.001|0.673|0.0508
70959177|NCT01350336|141422381|NON_INFERIORITY|An upper 95% confidence limit of the difference between Year 2 compared to the first 12-month proportion is less than 20% will demonstrate that the proportions are not substantially worse during each of the subsequent evaluation periods.|Difference of proportions|-0.038|||||TWO_SIDED|95.0|-0.1251|0.0497||||||Comparison of Years 1 and 2||0.0497|-0.1251|
70959178|NCT01350336|141422381|NON_INFERIORITY|An upper 95% confidence limit of the difference between Year 3 compared to the first 12-month proportion is less than 20% will demonstrate that the proportions are not substantially worse during each of the subsequent evaluation periods.|Difference of proportions|-0.0325|||||TWO_SIDED|95.0|-0.1197|0.0565||||||Comparison of Years 1 and 3||0.0565|-0.1197|
70959179|NCT01350336|141422381|NON_INFERIORITY|An upper 95% confidence limit of the difference between Year 4 compared to the first 12-month proportion is less than 20% will demonstrate that the proportions are not substantially worse during each of the subsequent evaluation periods.|Difference of proportions|-0.0566|||||TWO_SIDED|95.0|-0.1444|0.0329||||||Comparison of Years 1 and 4||0.0329|-0.1444|
70959180|NCT01350336|141422381|NON_INFERIORITY|An upper 95% confidence limit of the difference between Year 5 compared to the first 12-month proportion is less than 20% will demonstrate that the proportions are not substantially worse during each of the subsequent evaluation periods.|Difference of proportions|-0.0765|||||TWO_SIDED|95.0|-0.1661|0.013||||||Comparison of Years 1 and 5||0.0130|-0.1661|
70959181|NCT02795429|141422404|SUPERIORITY||Odds Ratio (OR)|0.561|||||||||||Bayesian Logistic Regression Model||Posterior probability that the odds ratio (ORRspartalizumab +capmatinib to ORRspartalizumab) was ≥ 1|||||
70959182|NCT03310268|141422432|OTHER||Difference of Least Square mean|0.19|STANDARD_ERROR_OF_MEAN|0.094||0.0476|TWO_SIDED|95.0|0.002|0.374|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.374|0.002|0.0476
70879322|NCT00380978|141244036|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.0|||<|0.005|TWO_SIDED|95.0|-4.0|-3.0|||Wilcoxon (Mann-Whitney)|||||-3|-4|<0.005
70959183|NCT03310268|141422432|OTHER||Difference of Least Square mean|-0.02|STANDARD_ERROR_OF_MEAN|0.093||0.8411|TWO_SIDED|95.0|-0.202|0.164|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.164|-0.202|0.8411
70959184|NCT03310268|141422432|OTHER||Difference of Least Square mean|0.21|STANDARD_ERROR_OF_MEAN|0.094||0.0298|TWO_SIDED|95.0|0.02|0.393|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.393|0.020|0.0298
70959185|NCT03310268|141422433|OTHER||Difference of Least Square mean|-7.2|STANDARD_ERROR_OF_MEAN|4.649||0.1232|TWO_SIDED|95.0|-16.376|1.975|||ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||1.975|-16.376|0.1232
70879323|NCT00380978|141244037|SUPERIORITY_OR_OTHER||||||<|0.005||95.0|||||Chi-squared, Corrected|||||||<0.005
70879324|NCT00380978|141244038|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Fisher Exact|||||||0.11
70879325|NCT00380978|141244039|SUPERIORITY_OR_OTHER||||||<|0.005||95.0|||||Chi-squared, Corrected|||||||<0.005
70879326|NCT01729754|141244042|SUPERIORITY||Difference in percentages|59.8|||<|0.001|TWO_SIDED|95.0|52.9|65.9|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and confidence intervals (CIs) are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||65.9|52.9|<0.001
70879327|NCT01729754|141244042|SUPERIORITY||Difference in percentages|55.5|||<|0.001|TWO_SIDED|95.0|48.3|61.8|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||61.8|48.3|<0.001
70879328|NCT01729754|141244043|SUPERIORITY||Difference in percentages|54.7|||<|0.001|TWO_SIDED|95.0|47.9|60.8|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||60.8|47.9|<0.001
70879329|NCT01729754|141244043|SUPERIORITY||Difference in percentages|50.2|||<|0.001|TWO_SIDED|95.0|43.2|56.5||Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Cochran-Mantel-Haenszel||Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||56.5|43.2|<0.001
70879330|NCT01729754|141244046|SUPERIORITY||Difference in percentages|19.2|||<|0.001|TWO_SIDED|95.0|11.5|26.7||Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Cochran-Mantel-Haenszel||Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||26.7|11.5|<0.001
70879331|NCT01729754|141244046|SUPERIORITY||Difference in percentages|20.1|||<|0.001|TWO_SIDED|95.0|12.4|27.6||Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Cochran-Mantel-Haenszel||Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||27.6|12.4|<0.001
70879332|NCT01729754|141244049|SUPERIORITY||Difference in percentages|24.1|||<|0.001|TWO_SIDED|95.0|16.2|31.7|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||31.7|16.2|<0.001
70879333|NCT01729754|141244049|SUPERIORITY||Difference in percentages|19.6|||<|0.001|TWO_SIDED|95.0|11.7|27.3|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights|||27.3|11.7|<0.001
70879334|NCT01729754|141244052|SUPERIORITY||Difference in percentages|35.3|||<|0.001|TWO_SIDED|95.0|29.2|41.1|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||41.1|29.2|<0.001
70879335|NCT01729754|141244052|SUPERIORITY||Difference in percentages|37.5|||<|0.001|TWO_SIDED|95.0|31.1|43.4|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights|||43.4|31.1|<0.001
70879336|NCT01729754|141244052|SUPERIORITY||Difference in percentages|15.2|||<|0.001|TWO_SIDED|95.0|8.3|22.1|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||22.1|8.3|<0.001
70879337|NCT01729754|141244052|SUPERIORITY||Difference in percentages|17.4|||<|0.001|TWO_SIDED|95.0|10.3|24.4|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||24.4|10.3|<0.001
70879338|NCT01729754|141244053|OTHER||Difference in percentages|27.1|||<|0.001|TWO_SIDED|95.0|19.1|34.7||Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Cochran-Mantel-Haenszel||Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||34.7|19.1|<0.001
70879339|NCT01729754|141244053|OTHER||Difference in percentages|24.9|||<|0.001|TWO_SIDED|95.0|17.0|32.6|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||32.6|17.0|<0.001
70879340|NCT01729754|141244056|SUPERIORITY||Difference in percentages|11.7|||<|0.001|TWO_SIDED|95.0|7.8|16.0|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||16.0|7.8|<0.001
70879341|NCT01729754|141244056|SUPERIORITY||Difference in percentages|12.4|||<|0.001|TWO_SIDED|95.0|8.5|16.6|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||16.6|8.5|<0.001
70879342|NCT01729754|141244056|SUPERIORITY||Difference in percentages|7.0||||0.001|TWO_SIDED|95.0|2.8|11.6|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||11.6|2.8|0.001
70879343|NCT01729754|141244056|SUPERIORITY||Difference in percentages|7.6|||<|0.001|TWO_SIDED|95.0|3.3|12.3|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||12.3|3.3|<0.001
70879344|NCT01729754|141244057|SUPERIORITY||Difference in percentages|15.7|||<|0.001|TWO_SIDED|95.0|9.4|22.1|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||22.1|9.4|<0.001
70879345|NCT01729754|141244057|SUPERIORITY||Difference in percentages|11.7|||<|0.001|TWO_SIDED|95.0|5.6|17.9|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||17.9|5.6|<0.001
70879346|NCT01729754|141244061|OTHER||Difference in least squares means|-8.2|||<|0.001|TWO_SIDED|95.0|-9.3|-7.2|||cLDA|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-7.2|-9.3|<0.001
70879347|NCT01729754|141244061|OTHER||Difference in least squares means|-8.3|||<|0.001|TWO_SIDED|95.0|-9.3|-7.3|||cLDA|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-7.3|-9.3|<0.001
70879348|NCT01729754|141244061|OTHER||Difference in least squares means|-1.3||||0.002|TWO_SIDED|95.0|-2.1|-0.5|||cLDA|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-0.5|-2.1|0.002
70879349|NCT01729754|141244061|OTHER||Difference in least squares means|-1.4||||0.001|TWO_SIDED|95.0|-2.2|-0.6|||cLDA|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-0.6|-2.2|0.001
70879350|NCT01729754|141244062|OTHER||Difference in least squares means|-1.7|||<|0.001|TWO_SIDED|95.0|-2.4|-1.0|||cLDA|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-1.0|-2.4|<0.001
70879351|NCT01729754|141244062|OTHER||Difference in least squares means|-2.2|||<|0.001|TWO_SIDED|95.0|-2.9|-1.5|||cLDA|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-1.5|-2.9|<0.001
70959186|NCT03310268|141422433|OTHER||Difference of Least Square mean|-4.04|STANDARD_ERROR_OF_MEAN|4.588||0.3793|TWO_SIDED|95.0|-13.099|5.011|||ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||5.011|-13.099|0.3793
70959187|NCT03310268|141422433|OTHER||Difference of Least Square mean|-3.16|STANDARD_ERROR_OF_MEAN|4.648||0.4979|TWO_SIDED|95.0|-12.33|6.017|||ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||6.017|-12.330|0.4979
70959188|NCT00706433|141422446|SUPERIORITY_OR_OTHER|||||||0.768||95.0|||||ANCOVA|Rank ANCOVA with baseline total inflammatory lesion counts serving as the covariate.||Null hypothesis: equal median changes from baseline in total inflammatory lesion counts among the treatments||||0.7680
70959189|NCT00706433|141422447|SUPERIORITY_OR_OTHER|||||||0.7975||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Null hypothesis: equal success rates.||||0.7975
70959190|NCT00706433|141422448|SUPERIORITY_OR_OTHER||||||>|0.1||95.0|||||ANOVA|Rank transformed data.||Null hypothesis: equal median percent changes from baseline in total inflammatory lesion counts among the treatments||||>0.10
70959191|NCT00706433|141422449|SUPERIORITY_OR_OTHER||||||>|0.1||95.0|||||ANOVA|Rank transformed data.||Null hypothesis: equal median percent changes from baseline in total inflammatory lesion counts among the treatments||||>0.10
70879352|NCT01729754|141244065|OTHER||Difference in percentages|39.3|||<|0.001|TWO_SIDED|95.0|31.8|46.1|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||46.1|31.8|<0.001
70879353|NCT01729754|141244065|OTHER||Difference in percentages|32.1|||<|0.001|TWO_SIDED|95.0|24.5|39.1|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||39.1|24.5|<0.001
70959192|NCT00706433|141422451|SUPERIORITY_OR_OTHER|||||||0.1103||95.0|||||ANCOVA|Rank ANCOVA with baseline total inflammatory lesion counts serving as the covariate.||Null hypothesis: equal median changes from baseline in total inflammatory lesion counts among the treatments||||0.1103
70959193|NCT00706433|141422452|SUPERIORITY_OR_OTHER|||||||0.7228||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Null hypothesis: equal success rates.||||0.7228
70879354|NCT01729754|141244065|OTHER||Difference in percentages|11.9||||0.003|TWO_SIDED|95.0|4.1|19.5|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||19.5|4.1|0.003
70879355|NCT01729754|141244065|OTHER||Difference in percentages|4.8||||0.221|TWO_SIDED|95.0|-2.9|12.5|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||12.5|-2.9|0.221
70879356|NCT01729754|141244066|OTHER||Difference in percentages|25.7|||<|0.001|TWO_SIDED|95.0|17.7|33.4|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||33.4|17.7|<0.001
70879357|NCT01729754|141244066|OTHER||Difference in percentages|15.0|||<|0.001|TWO_SIDED|95.0|6.9|22.9|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||22.9|6.9|<0.001
70879358|NCT00773292|141244076|OTHER|change from baseline||||||0.24|||||||t-test, 2 sided|||||||0.24
70879359|NCT04608500|141244101|SUPERIORITY||Mean Difference (Final Values)|3.85|STANDARD_ERROR_OF_MEAN|0.861|<|0.0001|TWO_SIDED|95.0|2.16|5.54|||ANCOVA|Analysis of covariance (ANCOVA) model includes treatment, Baseline inflammatory lesion count, and analysis center.||||5.54|2.16|<0.0001
70879360|NCT04608500|141244102|SUPERIORITY||Risk Ratio (RR)|1.263||||0.0077|TWO_SIDED|95.0|1.064|1.499||The p-value is for the null hypothesis that the combined risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by analysis center.||||1.499|1.064|0.0077
70879361|NCT04608500|141244103|SUPERIORITY||Risk Ratio (RR)|1.193||||0.0189|TWO_SIDED|95.0|1.024|1.39||The p-value is for the null hypothesis that the combined risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Test Stratified by Analysis Center||||1.390|1.024|0.0189
70879362|NCT04608500|141244104|SUPERIORITY||Mean Difference (Final Values)|11.3|STANDARD_ERROR_OF_MEAN|2.672|<|0.0001|TWO_SIDED|95.0|6.05|16.54|||ANCOVA|ANCOVA model includes treatment, Baseline inflammatory lesion count, and analysis center.||||16.54|6.05|<0.0001
70879363|NCT04608500|141244105|SUPERIORITY||Mean Difference (Final Values)|4.38|STANDARD_ERROR_OF_MEAN|0.821|<|0.0001|TWO_SIDED|95.0|2.77|5.99|||ANCOVA|ANCOVA model includes treatment, Baseline inflammatory lesion count, and analysis center.||Statistical Analysis For Week 4||5.99|2.77|<0.0001
70879364|NCT04608500|141244105|SUPERIORITY||Mean Difference (Final Values)|5.07|STANDARD_ERROR_OF_MEAN|0.793|<|0.0001|TWO_SIDED|95.0|3.52|6.63|||ANCOVA|ANCOVA model includes treatment, Baseline inflammatory lesion count, and analysis center.||Statistical Analysis For Week 8||6.63|3.52|<0.0001
70879365|NCT04608500|141244106|SUPERIORITY||Risk Ratio (RR)|1.715||||0.0114|TWO_SIDED|95.0|1.129|2.605||p-value is for the null hypothesis that the risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by analysis center.||Statistical Analysis For Week 4||2.605|1.129|0.0114
70959194|NCT00706433|141422453|SUPERIORITY_OR_OTHER|||||||0.3416||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates||||0.3416
70959195|NCT00706433|141422454|SUPERIORITY_OR_OTHER|||||||0.5759||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5759
70959196|NCT00706433|141422455|SUPERIORITY_OR_OTHER|||||||0.4754||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4754
70959197|NCT00706433|141422456|SUPERIORITY_OR_OTHER|||||||0.4096||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4096
70959198|NCT00706433|141422457|SUPERIORITY_OR_OTHER|||||||0.5812||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5812
70959199|NCT00706433|141422458|SUPERIORITY_OR_OTHER|||||||0.8679||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.8679
70959200|NCT00706433|141422459|SUPERIORITY_OR_OTHER|||||||0.3666||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3666
70959201|NCT00706433|141422460|SUPERIORITY_OR_OTHER|||||||0.308||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3080
70959202|NCT00706433|141422461|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
70959203|NCT00706433|141422462|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
70879366|NCT04608500|141244106|SUPERIORITY||Risk Ratio (RR)|1.319||||0.0061|TWO_SIDED|95.0|1.082|1.607||p-value is for the null hypothesis that the risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by analysis center.||Statistical Analysis For Week 8||1.607|1.082|0.0061
70879367|NCT03928847|141244108|SUPERIORITY|The mean EGCG blood levels were compared among 450 mg, 600 mg, and 750 mg groups.|Mean Difference (Net)|250.0|||||TWO_SIDED|||||||||||||
70959204|NCT00706433|141422463|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
70959205|NCT00706433|141422464|SUPERIORITY_OR_OTHER|||||||0.3916||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3916
70959206|NCT00706433|141422465|SUPERIORITY_OR_OTHER|||||||0.8387||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.8387
70959207|NCT00706433|141422466|SUPERIORITY_OR_OTHER|||||||0.1489||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1489
70879368|NCT03928847|141244109|OTHER|ELISA data from each patient before and after EGCG treatment were compared and analyzed with the use of the Wilcoxon signed-rank test (two-tailed).|||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
70959208|NCT00706433|141422467|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||<0.0001
70959209|NCT00706433|141422467|SUPERIORITY_OR_OTHER|||||||0.4143||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4143
70959210|NCT00706433|141422467|SUPERIORITY_OR_OTHER|||||||0.0005||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0005
70959211|NCT00706433|141422467|SUPERIORITY_OR_OTHER|||||||0.0003||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0003
70959212|NCT00706433|141422467|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||<0.0001
70879369|NCT03928847|141244110|OTHER|ELISA data from each patient before and after EGCG treatment were compared and analyzed with the use of the Wilcoxon signed-rank test (two-tailed).|||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
70879370|NCT03928847|141244111|OTHER||||||<|0.01|||||||Kruskal-Wallis|||||||<0.01
70879371|NCT03928847|141244112|OTHER||||||<|0.01|||||||Kruskal-Wallis|||||||<0.01
70879372|NCT03928847|141244113|OTHER||||||<|0.01|||||||Kruskal-Wallis|||||||<0.01
70879373|NCT01010906|141244114|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval falls within the interval \[0.50, 2.00\], then treatment of HI participants is similar to treatment of healthy matched for mild HI participants.|Geometric Least-Square Mean Ratio|1.82|||||TWO_SIDED|90.0|0.96|3.43||||||||3.43|0.96|
70879374|NCT01010906|141244114|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval falls within the interval \[0.50, 2.00\], then treatment of HI participants is similar to treatment of healthy matched for moderate HI participants.|Geometric Least-Square Mean Ratio|3.11|||||TWO_SIDED|90.0|1.6|6.04||||||||6.04|1.60|
70879375|NCT01010906|141244114|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval falls within the interval \[0.50, 2.00\], then treatment of HI participants is similar to treatment of healthy matched for severe HI participants.|Geometric Least-Square Mean Ratio|8.42|||||TWO_SIDED|90.0|5.2|13.64||||||||13.64|5.20|
70879376|NCT01010906|141244115|SUPERIORITY_OR_OTHER||Geometric Least-Square Mean Ratio|1.57|||||TWO_SIDED|90.0|0.76|3.24||||||||3.24|0.76|
70879377|NCT01010906|141244115|SUPERIORITY_OR_OTHER||Geometric Least-Square Mean Ratio|2.21|||||TWO_SIDED|90.0|1.21|4.03||||||||4.03|1.21|
70879378|NCT01010906|141244115|SUPERIORITY_OR_OTHER||Geometric Least-Square Mean Ratio|6.16|||||TWO_SIDED|90.0|3.9|9.71||||||||9.71|3.90|
70879379|NCT01881230|141244122|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.692||||0.0183|TWO_SIDED|95.0|1.089|2.629|||Log Rank|||For stratified analysis, the stratified log-rank test and stratified Cox proportional hazards model were used, where the stratification factor is the disease free interval (\<= 1 year; \> 1 year).||2.629|1.089|0.0183
70879380|NCT01881230|141244122|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.581||||0.0152|TWO_SIDED|95.0|0.373|0.904|||Log Rank|||For stratified analysis, the stratified log-rank test and stratified Cox proportional hazards model were used, where the stratification factor is the disease free interval (\<= 1 year; \> 1 year).||0.904|0.373|0.0152
70879381|NCT01881230|141244122|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.039||||0.8599|TWO_SIDED|95.0|0.676|1.597|||Log Rank|||For stratified analysis, the stratified log-rank test and stratified Cox proportional hazards model were used, where the stratification factor is the disease free interval (\<= 1 year; \> 1 year).||1.597|0.676|0.8599
70879382|NCT01881230|141244125|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.375||||0.1579|TWO_SIDED|95.0|0.882|2.143|||Log Rank|||Hazard ratios and associated two-sided 95% confidence intervals were estimated using stratified Cox proportional hazard model. The stratification factor is the disease free interval (≤ 1 year; \> 1 year).||2.143|0.882|0.1579
70879383|NCT01881230|141244125|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.796||||0.2945|TWO_SIDED|95.0|0.52|1.221|||Log Rank|||Hazard ratios and associated two-sided 95% confidence intervals were estimated using stratified Cox proportional hazard model. The stratification factor is the disease free interval (≤ 1 year; \> 1 year).||1.221|0.520|0.2945
70879384|NCT01881230|141244125|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.101||||0.6691|TWO_SIDED|95.0|0.71|1.708|||Log Rank|||Hazard ratios and associated two-sided 95% confidence intervals were estimated using stratified Cox proportional hazard model. The stratification factor is the disease free interval (≤ 1 year; \> 1 year).||1.708|0.710|0.6691
70879385|NCT00112502|141244129|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.8|1.7||||||||1.7|0.8|
70879386|NCT00112502|141244130|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.6|1.2||||||||1.2|0.6|
70879387|NCT00112502|141244131|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.9|1.8||||||||1.8|0.9|
70879388|NCT00112502|141244132|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.6|1.3||||||||1.3|0.6|
70879389|NCT00112502|141244134|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.7|1.5||||||||1.5|0.7|
70879390|NCT00112502|141244135|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.5|1.2||||||||1.2|0.5|
70879391|NCT00112502|141244136|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.8|1.8||||||||1.8|0.8|
70879392|NCT00112502|141244137|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.5|1.1||||||||1.1|0.5|
70879393|NCT03739112|141244149|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the two-sided 95% confidence interval (CI) for relative vaccine efficacy (VE) was \> -20%.|percent VE|8.8|||||TWO_SIDED|95.0|-16.7|28.7|||||VE of VLP vaccine versus Fluarix = (1-ARVv/ARVc) x 100% where ARVv = attack rate in participants vaccinated with the Quadrivalent VLP Influenza vaccine and ARVc = attack rate in participants vaccinated with an active Fluarix.|||28.7|-16.7|
70879394|NCT01959542|141244181|OTHER|Pearson's product-moment correlation|Pearson's product-moment correlation|-0.53||||0.09|TWO_SIDED|95.0|-86.0|0.1|||Pearson's product-moment correlation|||||0.10|-086|0.09
70959213|NCT00706433|141422467|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||<0.0001
70959214|NCT00706433|141422467|SUPERIORITY_OR_OTHER|||||||0.97||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.9700
70959215|NCT00706433|141422468|SUPERIORITY_OR_OTHER|||||||0.2544||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2544
70959216|NCT00706433|141422469|SUPERIORITY_OR_OTHER|||||||0.4321||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4321
70879395|NCT01959542|141244182|OTHER||Pearson's product-moment correlation|-0.62||||0.03|TWO_SIDED|95.0|-0.62|-0.15|||Pearson's product-moment correlation|Pearson's product moment correlation||||-0.15|-0.62|0.03
70959217|NCT00706433|141422470|SUPERIORITY_OR_OTHER|||||||0.0317||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0317
70959218|NCT00706433|141422470|SUPERIORITY_OR_OTHER|||||||0.5818||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5818
70959219|NCT00706433|141422470|SUPERIORITY_OR_OTHER|||||||0.0395||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0395
70959220|NCT00706433|141422470|SUPERIORITY_OR_OTHER|||||||0.7426||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.7426
70959221|NCT00706433|141422470|SUPERIORITY_OR_OTHER|||||||0.0029||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0029
70959222|NCT00706433|141422470|SUPERIORITY_OR_OTHER|||||||0.2142||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2142
70959223|NCT00706433|141422470|SUPERIORITY_OR_OTHER|||||||0.0781||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0781
70959224|NCT00706433|141422471|SUPERIORITY_OR_OTHER|||||||0.9886||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.9886
70959225|NCT00706433|141422472|SUPERIORITY_OR_OTHER|||||||0.6907||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.6907
70959226|NCT00706433|141422473|SUPERIORITY_OR_OTHER|||||||0.0047||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0047
70959227|NCT00706433|141422473|SUPERIORITY_OR_OTHER|||||||0.6116||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.6116
70959228|NCT00706433|141422473|SUPERIORITY_OR_OTHER|||||||0.0209||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0209
70959229|NCT00706433|141422473|SUPERIORITY_OR_OTHER|||||||0.0513||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0513
70959230|NCT00706433|141422473|SUPERIORITY_OR_OTHER|||||||0.0019||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0019
70959231|NCT00706433|141422473|SUPERIORITY_OR_OTHER|||||||0.0089||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0089
70959232|NCT00706433|141422473|SUPERIORITY_OR_OTHER|||||||0.526||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5260
70959233|NCT00706433|141422474|SUPERIORITY_OR_OTHER|||||||0.782||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.7820
70959234|NCT00706433|141422475|SUPERIORITY_OR_OTHER|||||||0.4965||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4965
70959235|NCT00706433|141422476|SUPERIORITY_OR_OTHER|||||||0.0728||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0728
70959236|NCT00706433|141422477|SUPERIORITY_OR_OTHER|||||||0.548||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5480
70959237|NCT00706433|141422478|SUPERIORITY_OR_OTHER|||||||0.0301||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0301
70959238|NCT00706433|141422478|SUPERIORITY_OR_OTHER|||||||0.0564||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0564
70959239|NCT00706433|141422478|SUPERIORITY_OR_OTHER|||||||0.447||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4470
70959240|NCT00706433|141422478|SUPERIORITY_OR_OTHER|||||||0.2804||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2804
70959241|NCT00706433|141422478|SUPERIORITY_OR_OTHER|||||||0.1835||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1835
70959242|NCT00706433|141422478|SUPERIORITY_OR_OTHER|||||||0.0103||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0103
70959243|NCT00706433|141422478|SUPERIORITY_OR_OTHER|||||||0.1319||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1319
70959244|NCT00706433|141422479|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
70959245|NCT00706433|141422480|SUPERIORITY_OR_OTHER|||||||0.4378||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4378
70959246|NCT00706433|141422481|SUPERIORITY_OR_OTHER|||||||0.343||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3430
70959247|NCT00706433|141422482|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
70879396|NCT03388138|141244204|NON_INFERIORITY|Non-inferiority of the etafilcon A with ketotifen lens relative to the etafilcon A lens was established if the upper limit of the 95% confidence interval was below 0.1 logMAR.|Least-Square Mean Difference|0.0017|STANDARD_ERROR_OF_MEAN|0.01169|||TWO_SIDED|95.0|-0.021|0.025|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as etafilcon A with ketotifen - etafilcon A|||0.025|-0.021|
70879397|NCT03388138|141244205|NON_INFERIORITY|Non-inferiority of the etafilcon A with ketotifen lens relative to the etafilcon A lens was established if the upper limit of the 95% confidence interval was below 0.1 logMAR.|Least-Square Mean Difference|0.0007|STANDARD_ERROR_OF_MEAN|0.01158|||TWO_SIDED|95.0|-0.022|0.024|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as etafilcon A with ketotifen - etafilcon A|||0.024|-0.022|
70959248|NCT00706433|141422483|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
70959249|NCT00706433|141422484|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
70959250|NCT00706433|141422485|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
70959251|NCT00706433|141422486|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
70959252|NCT00706433|141422487|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
70959253|NCT00706433|141422488|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
70959254|NCT00706433|141422489|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
70959255|NCT00706433|141422490|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
70879398|NCT01268111|141244209|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||t-test, 2 sided|||||||0.4
70959256|NCT00706433|141422491|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
70959257|NCT00706433|141422492|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
70959258|NCT00706433|141422493|SUPERIORITY_OR_OTHER|||||||0.0165||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0165
70959259|NCT00706433|141422493|SUPERIORITY_OR_OTHER|||||||0.2252||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2252
70959260|NCT00706433|141422493|SUPERIORITY_OR_OTHER|||||||0.0179||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0179
70959261|NCT00706433|141422493|SUPERIORITY_OR_OTHER|||||||0.0233||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0233
70959262|NCT00706433|141422493|SUPERIORITY_OR_OTHER|||||||0.1573||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1573
70959263|NCT00706433|141422493|SUPERIORITY_OR_OTHER|||||||0.2039||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2039
70959264|NCT00706433|141422493|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
70959265|NCT00706433|141422494|SUPERIORITY_OR_OTHER|||||||0.1594||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1594
70879399|NCT02529137|141244221|NON_INFERIORITY|the non-inferiority margin was set at 4%|difference|0.4|||||TWO_SIDED|95.0|-0.3|1.01||||||||1.01|-0.30|
70879400|NCT02063854|141244222|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested using t-test at a one-sided significance level of 2.5% and a non-inferiority margin (Δ) of 1.5%.||||||0.1346|||||||t-test, 1 sided|With a non-inferiority margin (Δ) of 1.5%.||||||0.1346
70879401|NCT02063854|141244222|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested using t-test at a one-sided significance level of 2.5% and a non-inferiority margin (Δ) of 1.5%.||||||0.6711|||||||t-test, 1 sided|With a non-inferiority margin (Δ) of 1.5%.||||||0.6711
70959266|NCT00706433|141422495|SUPERIORITY_OR_OTHER|||||||0.5838||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5838
70959267|NCT00706433|141422496|SUPERIORITY_OR_OTHER|||||||0.0064||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0064
70959268|NCT00706433|141422496|SUPERIORITY_OR_OTHER|||||||0.0939||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0939
70959269|NCT00706433|141422496|SUPERIORITY_OR_OTHER|||||||0.3173||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3173
70959270|NCT00706433|141422496|SUPERIORITY_OR_OTHER|||||||0.2207||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2207
70959271|NCT00706433|141422496|SUPERIORITY_OR_OTHER|||||||0.0183||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0183
70959272|NCT00706433|141422496|SUPERIORITY_OR_OTHER|||||||0.0254||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0254
70879402|NCT02063854|141244222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|||||TWO_SIDED|95.0|-1.92|0.001||||||||0.001|-1.920|
70879403|NCT02063854|141244222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71|||||TWO_SIDED|95.0|-2.617|-0.794||||||||-0.794|-2.617|
70879404|NCT02063854|141244222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75|||||TWO_SIDED|95.0|-0.166|1.658||||||||1.658|-0.166|
70879405|NCT03538158|141244235|SUPERIORITY||Slope|5.7||||0.82|TWO_SIDED|95.0|-287.7|299.1|||Mixed Models Analysis|F(2,131)=.07||||299.1|-287.7|.82
70879406|NCT03538158|141244236|SUPERIORITY||Slope|0.5||||0.97|TWO_SIDED|95.0|-3.5|4.4|||Mixed Models Analysis|F(2,75)=.03||||4.4|-3.5|.97
70879407|NCT00930579|141244241|OTHER|This study used two-sided t-tests to compare changes within group- before and after metformin treatment.|Mean Difference (Final Values)|-0.006||||0.98|TWO_SIDED||||||paired t-test|||Null hypothesis: there will be no statistically significant change between the amount of Ki-67 (protein involved in cell proliferation) in participants' tumor cells before and after taking the prescribed dose of Metformin, as measured at the 5% significance level.||||0.98
70879408|NCT01519414|141244276|OTHER|||||||0.02|||||||Log Rank|||||||0.02
70879409|NCT03194555|141244303|SUPERIORITY||Risk Difference (RD)|-2.17||||0.4267|TWO_SIDED|95.0|-3.67|8.01|||Chi-squared|||||8.01|-3.67|0.4267
70879410|NCT03194555|141244304|SUPERIORITY||Risk Difference (RD)|2.0||||0.268|TWO_SIDED|95.0|-18.46|66.83|||Chi-squared|||||66.83|-18.46|0.268
70879411|NCT03194555|141244305|SUPERIORITY||Risk Difference (RD)|3.0||||0.0926|TWO_SIDED|95.0|-17.2|67.4|||Chi-squared|||||67.4|-17.2|0.0926
70879412|NCT03194555|141244306|SUPERIORITY||Risk Difference (RD)|2.0||||0.2894|TWO_SIDED|95.0|-17.2|67.4|||Chi-squared|||||67.4|-17.2|0.2894
70879413|NCT03194555|141244307|SUPERIORITY||Risk Difference (RD)|-1.83||||0.5724|TWO_SIDED|95.0|-5.1557|8.8157|||Chi-squared|||||8.8157|-5.1557|0.5724
70879414|NCT03194555|141244308|SUPERIORITY||Risk Difference (RD)|-9.84||||0.2998|TWO_SIDED|95.0|-11.15|30.83|||Chi-squared|||||30.83|-11.15|0.2998
70879415|NCT03194555|141244309|SUPERIORITY||Risk Difference (RD)|-11.67||||0.2673|TWO_SIDED||||||Chi-squared|||||||0.2673
70959273|NCT00706433|141422496|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
70879416|NCT03194555|141244312|SUPERIORITY||Risk Difference (RD)|28.76||||0.3527|TWO_SIDED|95.0|-94.5005|36.9805|||Chi-squared|||||36.9805|-94.5005|0.3527
70879417|NCT03194555|141244313|SUPERIORITY||Risk Difference (RD)|-1.95||||0.5246|TWO_SIDED||||||Chi-squared|||||||0.5246
70879418|NCT03194555|141244315|SUPERIORITY||Risk Difference (RD)|0.34||||0.8649|TWO_SIDED||||||Chi-squared|||||||0.8649
70879419|NCT03706794|141244355|SUPERIORITY||Mann-Whitney U|43.0||||0.829|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.829
70879420|NCT03706794|141244356|SUPERIORITY||Mann-Whitney U|45.5||||0.633|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.633
70879421|NCT03706794|141244357|SUPERIORITY||Mann-Whitney U|45.5||||0.633|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.633
70879422|NCT03706794|141244358|SUPERIORITY||Mann-Whitney U|46.0||||0.633|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.633
70879423|NCT03706794|141244359|SUPERIORITY||Mann-Whitney U|52.0||||0.315|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.315
70879424|NCT03526458|141244392|SUPERIORITY||Mean Difference (Final Values)|16.6|STANDARD_ERROR_OF_MEAN|5.6||0.012|TWO_SIDED|95.0|4.4|28.9|||t-test, 2 sided|||||28.9|4.4|0.012
70879425|NCT03526458|141244393|SUPERIORITY||Mean Difference (Final Values)|11.3|STANDARD_ERROR_OF_MEAN|7.3||0.132|TWO_SIDED|95.0|-3.6|26.3|||t-test, 2 sided|||||26.3|-3.6|0.132
70879426|NCT03526458|141244394|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|2.7||0.654|TWO_SIDED|95.0|-4.4|6.9|||t-test, 2 sided|||||6.9|-4.4|0.654
70879427|NCT03526458|141244395|SUPERIORITY|||||||0.299|||||||Chi-squared|||||||0.299
70879428|NCT03526458|141244396|SUPERIORITY|||||||0.076|||||||Chi-squared|||||||0.076
70879429|NCT03526458|141244397|SUPERIORITY||Mean Difference (Final Values)|10.4|STANDARD_ERROR_OF_MEAN|143.9||0.943|TWO_SIDED|95.0|-286.0|306.8|||t-test, 2 sided|||||306.8|-286|0.943
70879430|NCT03526458|141244398|SUPERIORITY|||||||0.185|||||||Chi-squared|||||||0.185
70879431|NCT02404285|141244429|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
70879432|NCT02404285|141244431|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
70879433|NCT01082965|141244447|SUPERIORITY_OR_OTHER||Leasts Square (LS) Mean|-0.01|STANDARD_ERROR_OF_MEAN|0.265||0.9742|TWO_SIDED|95.0|-0.6|0.58||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Mixed model for repeated measures (MMRM) was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, Apolipoprotein E (ApoE) genotype, site as covariates.||0.58|-0.60|0.9742
70879434|NCT01082965|141244448|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.232||0.9638|TWO_SIDED|95.0|-0.51|0.49||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.49|-0.51|0.9638
70879435|NCT01082965|141244449|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.153||0.2548|TWO_SIDED|95.0|-0.53|0.16||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.16|-0.53|0.2548
70879436|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.057||0.6316|TWO_SIDED|95.0|-0.18|0.12||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Whole Brain Gray: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.12|-0.18|0.6316
70879437|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.063||0.6256|TWO_SIDED|95.0|-0.12|0.19||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Whole Brain Gray: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.19|-0.12|0.6256
70879438|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.059||0.5847|TWO_SIDED|95.0|-0.12|0.19||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Whole Brain Gray: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.19|-0.12|0.5847
70959274|NCT00706433|141422497|SUPERIORITY_OR_OTHER|||||||0.4753||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4753
70879439|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.123||0.1555|TWO_SIDED|95.0|-0.46|0.09||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Superior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.09|-0.46|0.1555
70879440|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.151||0.2416|TWO_SIDED|95.0|-0.51|0.14||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Superior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.14|-0.51|0.2416
70879441|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.134||0.807|TWO_SIDED|95.0|-0.33|0.26||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Superior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.26|-0.33|0.8070
70879442|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.189||0.6828|TWO_SIDED|95.0|-0.59|0.43||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Medial Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.43|-0.59|0.6828
70879443|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.109||0.8987|TWO_SIDED|95.0|-0.26|0.29||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Medial Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.29|-0.26|0.8987
70879444|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.117||0.8922|TWO_SIDED|95.0|-0.28|0.25||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Medial Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.25|-0.28|0.8922
70879445|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.203||0.7555|TWO_SIDED|95.0|-0.39|0.52||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Inferior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.52|-0.39|0.7555
70879446|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.218||0.1928|TWO_SIDED|95.0|-0.18|0.79||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Inferior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.79|-0.18|0.1928
70879447|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.161||0.4946|TWO_SIDED|95.0|-0.26|0.49||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Inferior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.49|-0.26|0.4946
70959275|NCT00706433|141422498|SUPERIORITY_OR_OTHER|||||||0.1728||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1728
70959276|NCT00706433|141422499|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0002
70879448|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.196||0.7029|TWO_SIDED|95.0|-0.56|0.4||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Medial Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.40|-0.56|0.7029
70959277|NCT00706433|141422499|SUPERIORITY_OR_OTHER|||||||0.5313||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5313
70879449|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.171||0.1085|TWO_SIDED|95.0|-0.68|0.08||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Medial Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.08|-0.68|0.1085
70879450|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.132||0.3588|TWO_SIDED|95.0|-0.44|0.18||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Medial Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.18|-0.44|0.3588
70879451|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.151||0.3053|TWO_SIDED|95.0|-0.2|0.53||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Inferior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.53|-0.20|0.3053
70959278|NCT00706433|141422499|SUPERIORITY_OR_OTHER|||||||0.0045||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0045
70959279|NCT00706433|141422499|SUPERIORITY_OR_OTHER|||||||0.0045||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0045
70959280|NCT00706433|141422499|SUPERIORITY_OR_OTHER|||||||0.0012||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0012
70959281|NCT00706433|141422499|SUPERIORITY_OR_OTHER|||||||0.0015||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0015
70879452|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.16||0.9861|TWO_SIDED|95.0|-0.36|0.36||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Inferior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.36|-0.36|0.9861
70879453|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.6558|TWO_SIDED|95.0|-0.41|0.28||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Inferior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.28|-0.41|0.6558
70879454|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.145||0.9471|TWO_SIDED|95.0|-0.53|0.51||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Superior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.51|-0.53|0.9471
70879455|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.186||0.2136|TWO_SIDED|95.0|-0.77|0.23||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Superior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.23|-0.77|0.2136
70879456|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.189||0.6435|TWO_SIDED|95.0|-0.47|0.67||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Superior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.67|-0.47|0.6435
70879457|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.086||0.0659|TWO_SIDED|95.0|-0.41|0.02||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Inferior Parietal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.02|-0.41|0.0659
70879458|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.158||0.7687|TWO_SIDED|95.0|-0.41|0.31||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Inferior Parietal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.31|-0.41|0.7687
70879459|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.163||0.1061|TWO_SIDED|95.0|-0.73|0.1||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Inferior Parietal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.10|-0.73|0.1061
70879460|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.124||0.3925|TWO_SIDED|95.0|-0.41|0.19||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Insula: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.19|-0.41|0.3925
70879461|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.161||0.1991|TWO_SIDED|95.0|-0.58|0.14||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Insula: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.14|-0.58|0.1991
70879462|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.151||0.5176|TWO_SIDED|95.0|-0.45|0.24||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Insula: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.24|-0.45|0.5176
70879463|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.143||0.314|TWO_SIDED|95.0|-0.5|0.18||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Precuneus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.18|-0.50|0.3140
70879464|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.171||0.6348|TWO_SIDED|95.0|-0.46|0.29||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Precuneus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.29|-0.46|0.6348
70879465|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.165||0.1491|TWO_SIDED|95.0|-0.64|0.12||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Precuneus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.12|-0.64|0.1491
70959282|NCT00706433|141422499|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
70879466|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.192||0.4226|TWO_SIDED|95.0|-0.59|0.27||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Anterior Cingulate Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.27|-0.59|0.4226
70879467|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.228||0.9778|TWO_SIDED|95.0|-0.49|0.5||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Anterior Cingulate Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.50|-0.49|0.9778
70959283|NCT00706433|141422500|SUPERIORITY_OR_OTHER|||||||0.0892||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0892
70959284|NCT00706433|141422501|SUPERIORITY_OR_OTHER|||||||0.4575||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4575
70879468|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.179||0.9456|TWO_SIDED|95.0|-0.4|0.43||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Anterior Cingulate Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.43|-0.40|0.9456
70879469|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.162||0.2299|TWO_SIDED|95.0|-0.55|0.15||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Amygdala: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.15|-0.55|0.2299
70879470|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.188||0.5069|TWO_SIDED|95.0|-0.54|0.28||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Amygdala: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.28|-0.54|0.5069
70879471|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.143||0.3524|TWO_SIDED|95.0|-0.45|0.17||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Amygdala: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.17|-0.45|0.3524
70959285|NCT00706433|141422502|SUPERIORITY_OR_OTHER|||||||0.8848||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.8848
70959286|NCT00706433|141422503|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0008
70959287|NCT00706433|141422503|SUPERIORITY_OR_OTHER|||||||0.4091||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4091
70959288|NCT00706433|141422503|SUPERIORITY_OR_OTHER|||||||0.0176||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0176
70959289|NCT00706433|141422503|SUPERIORITY_OR_OTHER|||||||0.0245||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0245
70959290|NCT00706433|141422503|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0020
70959291|NCT00706433|141422503|SUPERIORITY_OR_OTHER|||||||0.0022||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0022
70959292|NCT00706433|141422503|SUPERIORITY_OR_OTHER|||||||0.9372||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.9372
70959293|NCT00706433|141422504|SUPERIORITY_OR_OTHER|||||||0.239||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2390
70959294|NCT00706433|141422505|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
70879472|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.358||0.4182|TWO_SIDED|95.0|-0.8|1.47||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Thalamus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||1.47|-0.80|0.4182
70879473|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_DEVIATION|0.326||0.363|TWO_SIDED|95.0|-0.42|1.04||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Thalamus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||1.04|-0.42|0.3630
70959295|NCT00706433|141422506|SUPERIORITY_OR_OTHER|||||||0.0463||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0463
70959296|NCT00706433|141422506|SUPERIORITY_OR_OTHER|||||||0.1261||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1261
70959297|NCT00706433|141422506|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
70959298|NCT00706433|141422506|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
70959299|NCT00706433|141422506|SUPERIORITY_OR_OTHER|||||||0.0947||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0947
70959300|NCT00706433|141422506|SUPERIORITY_OR_OTHER|||||||0.0886||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0886
70959301|NCT00706433|141422506|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
70879474|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.263||0.9837|TWO_SIDED|95.0|-0.73|0.74||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Thalamus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.74|-0.73|0.9837
70879475|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.102||0.0974|TWO_SIDED|95.0|-0.04|0.42||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Basal Ganglia: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.42|-0.04|0.0974
70879476|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.067||0.1246|TWO_SIDED|95.0|-0.04|0.27||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Basal Ganglia: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.27|-0.04|0.1246
70879477|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.119||0.619|TWO_SIDED|95.0|-0.2|0.32||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Basal Ganglia: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.32|-0.20|0.6190
70879478|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.635|TWO_SIDED|95.0|-0.39|0.25||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Hippocampus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.25|-0.39|0.6350
70879479|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.164||0.8205|TWO_SIDED|95.0|-0.4|0.32||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Hippocampus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.32|-0.40|0.8205
70879480|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.123||0.2959|TWO_SIDED|95.0|-0.42|0.14||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Hippocampus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.14|-0.42|0.2959
70879481|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.194||0.552|TWO_SIDED|95.0|-0.56|0.32||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Landau: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.32|-0.56|0.5520
70879482|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.22||0.9046|TWO_SIDED|95.0|-0.5|0.45||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Landau: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.45|-0.50|0.9046
70879483|NCT01082965|141244450|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.125||0.0402|TWO_SIDED|95.0|-0.62|-0.02||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Landau: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||-0.02|-0.62|0.0402
70879484|NCT01082965|141244451|SUPERIORITY_OR_OTHER||LS Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|12.11||0.688|TWO_SIDED|95.0|-21.82|31.82||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 1: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||31.82|-21.82|0.6880
70879485|NCT01082965|141244451|SUPERIORITY_OR_OTHER||LS Mean Difference|9.79|STANDARD_ERROR_OF_MEAN|9.143||0.3157|TWO_SIDED|95.0|-11.3|30.87||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||30.87|-11.30|0.3157
70879486|NCT01082965|141244451|SUPERIORITY_OR_OTHER||LS Mean Difference|9.86|STANDARD_ERROR_OF_MEAN|8.921||0.3228|TWO_SIDED|95.0|-13.56|33.28||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 8: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||33.28|-13.56|0.3228
70879487|NCT01082965|141244452|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.39|STANDARD_ERROR_OF_MEAN|3.479||0.254|TWO_SIDED|95.0|-12.9|4.12||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Total IR: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||4.12|-12.90|0.2540
70879488|NCT01082965|141244452|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.95||0.7684|TWO_SIDED|95.0|-4.17|5.37||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Total DR: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||5.37|-4.17|0.7684
70959302|NCT00706433|141422507|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||<0.0001
70879489|NCT01082965|141244453|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.059||0.494|TWO_SIDED|95.0|-0.09|0.17||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 1, Detection Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.17|-0.09|0.4940
70879490|NCT01082965|141244453|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.057||0.1031|TWO_SIDED|95.0|-0.02|0.22||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Detection Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.22|-0.02|0.1031
70879491|NCT01082965|141244453|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.048||0.3277|TWO_SIDED|95.0|-0.06|0.16||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 8, Detection Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.16|-0.06|0.3277
70879492|NCT01082965|141244453|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.029||0.6585|TWO_SIDED|95.0|-0.05|0.08||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 1, Identification Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.08|-0.05|0.6585
70879493|NCT01082965|141244453|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.033||0.8863|TWO_SIDED|95.0|-0.07|0.08||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Identification Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.08|-0.07|0.8863
70879494|NCT01082965|141244453|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.044||0.4388|TWO_SIDED|95.0|-0.06|0.13||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 8, Identification Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.13|-0.06|0.4388
70879495|NCT02587065|141244456|OTHER||Spearman's correlation coefficient|-0.85||||0.56|TWO_SIDED|95.0|-3.72|2.02|||Mixed-effects REML regression|||Adjusted change of convenience satisfaction domain of TSQM-9.||2.02|-3.72|0.56
70879496|NCT04035161|141244495|NON_INFERIORITY|A non-inferiority criterion with a 0.5 log10 margin will be implemented for the average treatment effect (ATE) of the Investigational Product compared to the Active Control (i.e., the upper two-sided 95% confidence bound of the post-product application bacterial load corrected for pre-product application bacterial load of the Investigational Product - Active Control should be less than 0.5 log10).|Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.15|0.16||||||"Abdomen at 10 minutes post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Active Control on the abdomen at 10 minutes post-product application. ATE was calculated using a linear regression model for each body site used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||0.16|-0.15|
70879497|NCT04035161|141244495|NON_INFERIORITY|A non-inferiority criterion with a 0.5 log10 margin will be implemented for the average treatment effect (ATE) of the Investigational Product compared to the Active Control (i.e., the upper two-sided 95% confidence bound of the post-product application bacterial load corrected for pre-product application bacterial load of the Investigational Product - Active Control should be less than 0.5 log10).|Mean Difference (Final Values)|-0.24|||||TWO_SIDED|95.0|-0.43|-0.05||||||"Groin at 10 minutes post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Active Control on the groin at 10 minutes post-product application. ATE was calculated using a linear regression model for each body site used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||-0.05|-0.43|
70879498|NCT04035161|141244495|SUPERIORITY||Mean Difference (Final Values)|1.82|||||TWO_SIDED|95.0|1.66|1.97||||||"Abdomen at 10 minutes post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Negative Control on the abdomen at 10 minutes post-product application. ATE was calculated using a linear regression model for each body site used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||1.97|1.66|
70959303|NCT00706433|141422507|SUPERIORITY_OR_OTHER|||||||0.0255||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0255
70959304|NCT00706433|141422507|SUPERIORITY_OR_OTHER|||||||0.0576||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0576
70959305|NCT00706433|141422507|SUPERIORITY_OR_OTHER|||||||0.0686||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0686
70959306|NCT00706433|141422507|SUPERIORITY_OR_OTHER|||||||0.0004||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0004
70959307|NCT00706433|141422507|SUPERIORITY_OR_OTHER|||||||0.0005||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0005
70959308|NCT00706433|141422507|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
70959309|NCT00706433|141422508|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0006
70959310|NCT00706433|141422508|SUPERIORITY_OR_OTHER|||||||0.0245||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0245
70879499|NCT04035161|141244495|SUPERIORITY||Mean Difference (Final Values)|2.38|||||TWO_SIDED|95.0|2.19|2.56||||||"Groin at 10 minutes post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Negative Control on the groin at 10 minutes post-product application. ATE was calculated using a linear regression model for each body site used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||2.56|2.19|
70879500|NCT04035161|141244498|NON_INFERIORITY|A non-inferiority criterion with a 0.5 log10 margin will be implemented for the average treatment effect (ATE) of the Investigational Product compared to the Active Control (i.e., the upper two-sided 95% confidence bound of the post-product application bacterial load corrected for pre-product application bacterial load of the Investigational Product - Active Control should be less than 0.5 log10).|Mean Difference (Final Values)|0.08|||||TWO_SIDED|95.0|-0.08|0.23||||||"Abdomen at 30 seconds post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Active Control on the abdomen at 30 seconds post-product application. ATE was calculated using a linear regression model for each body site used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||0.23|-0.08|
70879501|NCT04035161|141244498|SUPERIORITY||Mean Difference (Final Values)|1.99|||||TWO_SIDED|95.0|1.84|2.15||||||"Abdomen at 30 seconds post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Negative Control on the abdomen at 30 seconds post-product application. ATE was calculated using a linear regression model for each body site used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||2.15|1.84|
70879502|NCT03479307|141244502|SUPERIORITY||Mean Difference (Final Values)|-0.71|||<|0.0001|TWO_SIDED|95.0|-1.013|-0.407|||ANCOVA|||Treatment Difference (95% CI): Bilastine Ophthalmic Solution 0.6% arm minus Vehicle of Bilastine Ophthalmic Solution arm at Visit 4b (including all time points).||-0.407|-1.013|< 0.0001
70879503|NCT03479307|141244502|SUPERIORITY||Mean Difference (Final Values)|-1.167|||<|0.0001|TWO_SIDED|95.0|-1.439|-0.895|||ANCOVA|||Treatment Difference (95% CI): Bilastine Ophthalmic Solution 0.6% arm minus Vehicle of Bilastine Ophthalmic Solution arm at Visit 5 (including all time points).||-0.895|-1.439|< 0.0001
70879504|NCT03479307|141244502|SUPERIORITY||Mean Difference (Final Values)|-1.14|||<|0.0001|TWO_SIDED|95.0|-1.413|-0.868|||ANCOVA|||Treatment Difference (95% CI): Ketotifen Ophthalmic Solution 0.025% (Zaditen) arm minus Vehicle of Bilastine Ophthalmic Solution arm at Visit 5 (including all time points).||-0.868|-1.413|< 0.0001
70879505|NCT03479307|141244502|NON_INFERIORITY|Non-inferiority margin of 0.40|Mean Difference (Final Values)|0.009||||0.0007|ONE_SIDED|97.5||0.235|||ANCOVA|||Treatment Difference (one-sided, 97.5% CI): Bilastine Ophthalmic Solution 0.6% arm minus Ketotiphen Ophthalmic Solution 0.025% (Zaditen) arm at Visit 5, 3 minutes Post-CAC (non-inferiority test).||0.235||0.0007
70879506|NCT03479307|141244502|NON_INFERIORITY|Non-inferiority margin of 0.40|Mean Difference (Final Values)|-0.077||||0.0002|ONE_SIDED|97.5||0.175|||ANCOVA|||Treatment Difference (one-sided, 97.5% CI): Bilastine Ophthalmic Solution 0.6% arm minus Ketotiphen Ophthalmic Solution 0.025% (Zaditen) arm at Visit 5, 5 minutes Post-CAC (non-inferiority test).||0.175||0.0002
70879507|NCT03479307|141244502|NON_INFERIORITY|Non-inferiority margin of 0.40|Mean Difference (Final Values)|-0.159|||<|0.0001|ONE_SIDED|97.5||0.101|||ANCOVA|||Treatment Difference (one-sided, 97.5% CI): Bilastine Ophthalmic Solution 0.6% arm minus Ketotiphen Ophthalmic Solution 0.025% (Zaditen) arm at Visit 5, 7 minutes Post-CAC (non-inferiority test).||0.101||< 0.0001
70879508|NCT02295995|141244536|OTHER|||||||||||||||||The between-group difference at 12 weeks \[mean difference (MD) and 95% Confidence Interval\] was calculated for all outcome measures. Cohen's d effect sizes were calculated as the difference in mean-level change (from baseline to 12 weeks) between the two groups divided by the standard deviation (SD) and is interpreted as d=0.20 (small), d=0.50 (medium), and d=0.80 (large). Cohen's d for physical activity in this sample was 1.37|Cohen's d calculated as the change from baseline to 12 weeks in both groups.|||
70879509|NCT02295995|141244537|OTHER|||||||||||||||||The between-group difference at 12 weeks \[mean difference (MD) and 95% Confidence Interval\] was calculated for all outcome measures. Cohen's d effect sizes were calculated as the difference in mean-level change (from baseline to 12 weeks) between the two groups divided by the standard deviation (SD) and is interpreted as d=0.20 (small), d=0.50 (medium), and d=0.80 (large). Cohen's d for PCL-5 in this sample was 0.38|Cohen's d calculated as the change from baseline to 12 weeks in both groups.|||
70879510|NCT02295995|141244538|OTHER|||||||||||||||||The between-group difference at 12 weeks \[mean difference (MD) and 95% Confidence Interval\] was calculated for all outcome measures. Cohen's d effect sizes were calculated as the difference in mean-level change (from baseline to 12 weeks) between the two groups divided by the standard deviation (SD) and is interpreted as d=0.20 (small), d=0.50 (medium), and d=0.80 (large). Cohen's d for 6-minute walk in this sample was 0.50|Cohen's d calculated as the change from baseline to 12 weeks in both groups.|||
70959311|NCT00706433|141422508|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
70879511|NCT01787175|141244550|SUPERIORITY_OR_OTHER||Difference in time to complete A&P|-17.73||||0.047|TWO_SIDED|95.0|-35.24|-0.23|||Mixed-effects linear model|||Null hypothesis: Participants will require the same amount of time to complete assessments and plans using either IMM or CPRS. Power calculation: With 2 replications per subject, and assuming an ICC of 0.15, a two-sided alpha 0.05 comparison adjusted for 5 multiple comparisons (adjusted alpha = 0.01), and power of 80%, an N of 32 clinicians was required for each group (32 using IMM, and 32 using CPRS).||-0.23|-35.24|0.047
70959312|NCT00706433|141422508|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
70959313|NCT00706433|141422508|SUPERIORITY_OR_OTHER|||||||0.0097||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0097
70959314|NCT00706433|141422508|SUPERIORITY_OR_OTHER|||||||0.0146||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0146
70879512|NCT01787175|141244551|SUPERIORITY_OR_OTHER||Value of problem scores for A&P complete|0.04||||0.15|TWO_SIDED|95.0|-0.01|0.09|||Mixed-effects linear model|||Null hypothesis: Participants will receive the same scores for assessments and plans completed using either IMM or CPRS. Power calculation: With 2 replications per subject, and assuming an ICC of 0.15, a two-sided alpha 0.05 comparison adjusted for 5 multiple comparisons (adjusted alpha = 0.01), and power of 80%, an N of 32 clinicians was required for each group (32 using IMM, and 32 using CPRS).||0.09|-0.01|0.15
70879513|NCT01787175|141244552|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9||||0.005|TWO_SIDED|95.0|1.22|2.98|||Regression, Logistic|||Null hypothesis: Participants will receive the same proportion of acceptable scores for assessments and plans completed using either IMM or CPRS. Power calculation: With 2 replications per subject, and assuming an ICC of 0.15, a two-sided alpha 0.05 comparison adjusted for 5 multiple comparisons (adjusted alpha = 0.01), and power of 80%, an N of 32 clinicians was required for each group (32 using IMM, and 32 using CPRS).||2.98|1.22|0.005
70879514|NCT02113956|141244554|SUPERIORITY||Incident Rate Ratio (IRR)|1.42|||||TWO_SIDED|95.0|0.79|2.57|||Poisson regression||Adjusted for age and baseline number of condomless sex acts|||2.57|0.79|
70879515|NCT02113956|141244555|SUPERIORITY||Odds Ratio (OR)|0.63|||||TWO_SIDED|95.0|0.36|1.12|||Regression, Logistic||||Adjusted for age and baseline rate of abstinence|1.12|0.36|
70879516|NCT02113956|141244556|SUPERIORITY||Incident Rate Ratio|0.95|||||TWO_SIDED|95.0|0.45|2.02|||Poisson||||Adjusted for age and baseline number of condomless sex acts|2.02|0.45|
70879517|NCT02113956|141244557|SUPERIORITY||Incident Rate Ratio (IRR)|0.62|||||TWO_SIDED|95.0|0.12|3.18|||Poisson||||Adjusted for age and baseline number of condomless sex acts|3.18|0.12|
70879518|NCT02113956|141244558|SUPERIORITY||Odds Ratio (OR)|0.48|||||TWO_SIDED|95.0|0.23|0.997|||Regression, Logistic||||Adjusted for age and baseline rate of abstinence|0.997|0.23|
70879519|NCT02113956|141244559|SUPERIORITY||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.38|2.53|||Regression, Logistic||||Adjusted for age and baseline rate of abstinence|2.53|0.38|
70879520|NCT02113956|141244560|SUPERIORITY||Odds Ratio (OR)|3.42|||||TWO_SIDED|95.0|1.65|7.09|||Regression, Logistic||||Adjusted for age and baseline rate of HIV testing|7.09|1.65|
70879521|NCT02113956|141244561|SUPERIORITY||Incident Risk Ratio (IRR)|0.58|||||TWO_SIDED|95.0|0.22|1.5|||Poisson||||Adjusted for age and baseline number of condomless sex acts|1.5|0.22|
70879522|NCT02113956|141244562|SUPERIORITY||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.6|2.09|||Regression, Logistic||||Adjusted for age and baseline rate of abstinence|2.09|0.6|
70959315|NCT00706433|141422508|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
70959316|NCT00706433|141422509|SUPERIORITY_OR_OTHER|||||||0.4235||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4235
70879523|NCT02113956|141244563|SUPERIORITY||Incident Rate Ratio (IRR)|0.6|||||TWO_SIDED|95.0|0.22|1.68|||||||Adjusted for age and baseline number of condomless sex acts|1.68|0.22|
70879524|NCT02113956|141244564|SUPERIORITY||Incident Rate Ratio (IRR)|1.1|||||TWO_SIDED|95.0|0.01|92.03|||||||Adjusted for age and baseline number of condomless sex acts|92.03|0.01|
70959317|NCT00706433|141422510|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
70879525|NCT02113956|141244565|SUPERIORITY||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.46|1.88|||Regression, Logistic||||Adjusted for age and baseline rate of abstinence|1.88|0.46|
70879526|NCT02113956|141244566|SUPERIORITY||Odds Ratio (OR)|3.4|||||TWO_SIDED|95.0|0.88|16.95|||Regression, Logistic||||Adjusted for age and baseline rate of abstinence|16.95|0.88|
70879527|NCT02113956|141244567|SUPERIORITY||Odds Ratio (OR)|3.39|||||TWO_SIDED|95.0|1.52|7.58|||Regression, Logistic||||Adjusted for age and baseline rate of HIV testing|7.58|1.52|
70879528|NCT02921776|141244589|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.45|TWO_SIDED||||||t-test, 2 sided|||||||0.45
70879529|NCT02921776|141244590|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.55|TWO_SIDED||||||t-test, 2 sided|||||||0.55
70879530|NCT02921776|141244591|OTHER|||||||0.1|||||||Effect size|Effect size =-0.29||||||0.10
70879531|NCT02921776|141244591|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.1|TWO_SIDED||||||t-test, 2 sided|||||||.10
70879532|NCT02921776|141244592|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||Benzodiazepine exposure||||0.02
70879533|NCT02921776|141244592|SUPERIORITY|||||||0.291|||||||Mixed Models Analysis|||Opioid Exposure||||0.291
70879534|NCT02921776|141244593|SUPERIORITY||Mean Difference (Final Values)|3.04||||0.38|TWO_SIDED||||||t-test, 2 sided|||||||0.38
70879535|NCT02921776|141244594|SUPERIORITY|||||||0.32|TWO_SIDED|95.0|||||Chi-squared|||||||0.32
70879536|NCT02921776|141244595|SUPERIORITY||Odds Ratio (OR)|0.93||||0.93|TWO_SIDED|95.0|0.19|4.72|||Mixed Models Analysis|||||4.72|0.19|0.93
70879537|NCT02921776|141244596|SUPERIORITY||Mean Difference (Final Values)|10.6||||0.07|TWO_SIDED||||||t-test, 2 sided|||||||0.07
70879538|NCT02921776|141244598|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||||||0.71
70879539|NCT02921776|141244599|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||Baseline||||0.94
70879540|NCT02921776|141244599|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||Patient Extubation or Discharge from ICU||||0.89
70879541|NCT02921776|141244599|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||1-Month||||0.38
70879542|NCT02921776|141244599|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||3-Month||||0.63
70879543|NCT02921776|141244599|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||||||.73
70879544|NCT02921776|141244600|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||Baseline||||0.82
70879545|NCT02921776|141244600|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||Patient extubation or discharge from ICU||||0.84
70879546|NCT02921776|141244600|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||1-month||||0.96
70879547|NCT02921776|141244600|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||3-Month||||0.17
70879548|NCT02921776|141244600|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||||||.39
70879549|NCT02921776|141244601|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||1-month||||0.26
70879550|NCT02921776|141244601|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||3-month||||0.25
70879551|NCT02921776|141244601|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||6-month||||0.79
70959318|NCT00706433|141422511|SUPERIORITY_OR_OTHER|||||||0.0865||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0865
70879552|NCT02921776|141244609|SUPERIORITY||Odds Ratio (OR)|0.23||||0.05|TWO_SIDED|95.0|0.05|1.01|||t-test, 2 sided|||||1.01|0.05|0.05
70879553|NCT02921776|141244609|SUPERIORITY||Odds Ratio (OR)|0.27||||0.1|TWO_SIDED|95.0|0.06|1.3|||Regression, Linear|||Adjusted for baseline communication difficulty||1.30|0.06|0.10
70879554|NCT02496533|141244621|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8|||<|0.001|TWO_SIDED|||||No multiple comparisons were conducted in this analysis. P-value not adjusted for multiple comparisons. No interim analyses performed.|ANOVA|||H0: No difference in reported anxiety as self-reported change of VAS between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.||||<0.001
70959319|NCT00706433|141422512|SUPERIORITY_OR_OTHER|||||||0.623||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.6230
70879555|NCT02496533|141244622|SUPERIORITY_OR_OTHER||||||<|0.02||||||No multiple comparisons were conducted in this analysis. P-value not adjusted for multiple comparisons. No interim analyses performed.|ANOVA|||H0: No difference in reported systolic blood pressure measurements between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.||||<0.02
70879556|NCT02496533|141244622|SUPERIORITY_OR_OTHER||||||<|0.09||||||No multiple comparisons were conducted in this analysis. P-Value not adjusted for multiple comparisons. No interim analyses were performed.|ANOVA|||H0: No difference in reported diastolic blood pressure between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.||||<0.09
70879557|NCT02496533|141244623|SUPERIORITY_OR_OTHER||||||<|0.009||||||No multiple comparisons were conducted in this analysis. P-value not adjusted for multiple comparisons. No interim analyses performed.|ANOVA|||H0: No difference in reported respiration rate between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.||||<0.009
70879558|NCT02496533|141244624|SUPERIORITY_OR_OTHER||||||<|0.45||||||No multiple comparisons were conducted in this analysis. P-value not adjusted for multiple comparisons. No interim analyses performed.|ANOVA|||H0: No difference in reported pulse rate between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.||||<0.45
70879559|NCT04729127|141244629|OTHER|||||||0.79|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.79
70879560|NCT04729127|141244629|OTHER|||||||0.27|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.27
70879561|NCT04729127|141244630|OTHER|||||||0.04|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.04
70879562|NCT04729127|141244630|OTHER|||||||0.02|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.02
70879563|NCT04729127|141244631|OTHER|||||||0.78|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.78
70879564|NCT04729127|141244631|OTHER|||||||0.89|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.89
70879565|NCT04729127|141244632|OTHER|||||||0.07|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.07
70879566|NCT04729127|141244632|OTHER|||||||0.88|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.88
70879567|NCT04729127|141244635|OTHER|||||||0.26|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.26
70879568|NCT04729127|141244635|OTHER|||||||0.74|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.74
70879569|NCT00525174|141244650|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Regression, Logistic|||Logistic regression was performed comparing the proportions of patients in each treatment group who had no improvement or worsening in amblyopic eye visual acuity from baseline to 24 weeks (change from baseline \<= +4 letters for E-ETDRS testing).||||0.02
70879570|NCT00525174|141244651|NON_INFERIORITY_OR_EQUIVALENCE|The trial was designed as a non-inferiority study. The sample size was computed to be 170 subjects to have 90% power and a type I error rate of 5% for a noninferiority limit of 0.075 logarithm of minimum angle of resolution (logMAR), based on assumed standard deviation of 24-week visual acuity scores of 0.16 logMAR, a correlation between baseline and final acuities of 0.20, and 10% noncompletion of the study primary outcome examination.|Mean Difference (Net)|0.38|||||ONE_SIDED|95.0||0.76|||ANCOVA|The logMAR visual acuity scores were adjusted for baseline amblyopic eye acuity.||The trial was designed as a non-inferiority study. The sample size was computed to be 170 subjects to have 90% power and a type I error rate of 5% for a noninferiority limit of 0.075 logarithm of minimum angle of resolution (logMAR), based on assumed standard deviation of 24-week visual acuity scores of 0.16 logMAR, a correlation between baseline and final acuities of 0.20, and 10% noncompletion of the study primary outcome examination.||0.76||
70879571|NCT00525174|141244651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.38||||0.09|TWO_SIDED|95.0|-0.06|0.83|||ANCOVA|The logMAR visual acuity scores were adjusted for baseline amblyopic eye acuity.||In addition to the test of non-inferiority, an efficacy test of Patching over Bangerter filters was also completed.||0.83|-0.06|0.09
70879572|NCT00525174|141244651|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Mixed Models Analysis|||Treatment group difference in rate of improvement was evaluated using a population averaged linear mixed model after performing an inverse transformation of time to obtain linearity.||||0.20
70879573|NCT00525174|141244651|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||ANCOVA|||The relationship between the fellow eye blur from the Bangerter filter at baseline and amblyopic improvement at the 24-week outcome was evaluated with an ANCOVA model with acuity in the fellow eye being categorized as better than versus equal to or worse than acuity in the amblyopic eye.||||0.49
70879574|NCT00525174|141244651|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||ANCOVA|||The association of fixation preference while the Bangerter filter was over the fellow eye at baseline (amblyopic eye, fellow eye, alternates) with 24-week amblyopic eye acuity was evaluated in an ANCOVA model.||||0.21
70879575|NCT00525174|141244653|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Regression, Logistic|||Logistic regression was used to compare the proportion of patients in each treatment group with amblyopic eye visual acuity within 1 line of the fellow eye or better.||||0.27
70879576|NCT00525174|141244654|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Regression, Logistic|||Logistic regression was used to compare the proportion of patients in each treatment group with amblyopic visual acuity 20/25 or better at 24 weeks.||||0.86
70879577|NCT00525174|141244654|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||Regression, Cox|||The time to first achieve amblyopic eye visual acuity of 20/25 or better was evaluated using a Cox proportional hazard model.||||0.28
70879578|NCT00525174|141244655|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Regression, Logistic|||Logistic regression was used to compare the proportion of patients with 3 or more lines of amblyopic eye visual acuity improvement from baseline to 24 weeks.||||0.61
70879579|NCT00525174|141244658|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Wilcoxon rank-sum|||A Wilcoxon rank-sum test was used to evaluate change in Randot Preschool stereoacuity levels from baseline to 24 weeks by treatment group.||||0.90
70879580|NCT00525174|141244659|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||Wilcoxon rank-sum|||A Wilcoxon rank-sum test was used to evaluate change in Randot Preschool stereoacuity levels from baseline to 24 weeks by treatment group.||||0.88
70879581|NCT00525174|141244661|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||ANCOVA|||A treatment group difference in the fellow eye visual acuity at 24 weeks was evaluated in an ANCOVA model adjusted for the baseline fellow eye acuity.||||0.07
70879582|NCT00525174|141244661|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Fisher Exact|||The Fisher exact test was used to compare the proportion of subjects in each treatment group who tested 2 or more logMAR lines worse in the fellow eye at 24 weeks compared with baseline.||||0.21
70879583|NCT00525174|141244662|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of impact of treatment at 6 weeks.||||0.03
70879584|NCT00525174|141244663|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of impact of treatment at 24 weeks.||||<0.001
70879585|NCT00525174|141244664|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of the adverse effects subscale at 6 weeks.||||0.90
70879586|NCT00525174|141244665|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of the adverse effects subscale at 24 weeks.||||0.01
70879587|NCT00525174|141244666|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of the compliance subscale at 6 weeks.||||0.12
70879588|NCT00525174|141244667|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of the compliance subscale at 24 weeks.||||0.001
70879589|NCT00525174|141244668|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of social stigma at 6 weeks.||||<0.001
70879590|NCT00525174|141244669|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of social stigma at 24 weeks.||||<0.001
70879591|NCT00870363|141244674|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Kruskal-Wallis|||||||>0.05
70879592|NCT01327300|141244686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.72||||0.001||95.0|||||t-test, 2 sided|||"The GIS scoring system is from 1-7 with one being a worse outcome and 7 the better outcome.~Comparisons below list the p values for comparison of difference in GIS between baseline and mesalamine."||||.001
70879593|NCT01327300|141244686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22||||0.008||95.0|||||t-test, 2 sided|||Comparisons of mean difference in GIS scores between baseline and placebo is made below.||||0.008
70879594|NCT01327300|141244687|SUPERIORITY_OR_OTHER|||||||0.873|||||||Wilcoxon (Mann-Whitney)|||Correlation coefficients were used for each of three biomarkers in relation to other biomarkers and to the questionnaires and patient's symptoms.||||0.873
70879595|NCT01327300|141244687|SUPERIORITY_OR_OTHER|||||||0.81|||||||Wilcoxon (Mann-Whitney)|Pearson's linear coefficient||The study tested three biomarkers and symptom domains at baseline and the end of 12 weeks of placebo using the Mann-Whitney test, as well as correlations between domains with Pearson's linear correlation coefficient.||||0.810
70879596|NCT01327300|141244688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.5||||0.67|||||||t-test, 2 sided|Two-tailed P values are listed for baseline versus 12 weeks of mesalamine||"The FBDSI score is based on the severity of abdominal pian. Severity is rated as the following:~None= 0 points Mild= (1-36) Moderate =(37-110) Severe= (\>110 points)"||||0.67
70879597|NCT01327300|141244688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.0||||0.77|||||||t-test, 2 sided|||See prior description of the FBDSI score. Change in the FBDSI after 12 weeks of intervention is made using a two sided t-test.||||0.77
70879598|NCT01327300|141244689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0||||0.61|||||||t-test, 2 sided|||For the IBS QOL we compared the change in IBS-Quality of Life (IBS-QOL) after 12 weeks of mesalamine.||||0.61
70879599|NCT01327300|141244689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.2||||0.33|||||||t-test, 2 sided|||Comparison of change in IBS-Quality of Life (IBS-QOL)from baseline after 12 weeks of intervention was made.||||0.33
70879600|NCT01327300|141244690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.71||95.0|||||t-test, 2 sided|||Comparison of the change in HADS score of baseline to 12 weeks of mesalamine is made.||||0.71
70879601|NCT01327300|141244690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.57||95.0|||||t-test, 2 sided|||Comparison of change in HADS score between baseline and after 12 weeks of placebo is made.||||0.57
70959320|NCT00706433|141422513|SUPERIORITY_OR_OTHER|||||||0.0963||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0963
70879602|NCT01327300|141244691|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||t-test, 2 sided|||Comparison of the lactulose/mannitol ratio is made after a 12 week intervention with mesalamine to 12 weeks of placebo.||||0.55
70879603|NCT02807350|141244696|OTHER||Risk Difference (RD)|19.0|||||TWO_SIDED|95.0|7.0|29.0||||||\>1 point analysis||29|7|
70879604|NCT02807350|141244696|OTHER|\>2 points analysis|Risk Difference (RD)|20.0|||||TWO_SIDED|95.0|10.0|28.0||||||||28|10|
70879605|NCT02807350|141244697|OTHER|\>1 analysis|Risk Difference (RD)|4.0|||||TWO_SIDED|95.0|-7.0|15.0||||||||15|-7|
70879606|NCT02807350|141244697|OTHER|\>2 analysis|Risk Difference (RD)|8.0|||||TWO_SIDED|95.0|-2.0|17.0||||||||17|-2|
70879607|NCT00587483|141244758|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.427|TWO_SIDED|95.0|0.48|1.37||An alpha of 0.0167 was used to account for multiple comparisons among the 3 groups. Given the total of 3 comparisons, 0.05/3 = 0.0167 was used in the calculation.|Regression, Logistic|||The expected overall incidence of ventricular fibrillation after removal of the aortic clamp is at least 70%. Using a chi square analysis with 80% power and an alpha of 0.0167, we estimate that we will need 113 patients in each group to show a 30% reduction in the incidence of ventricular fibrillation with amiodarone.||1.37|0.48|0.427
70879608|NCT00587483|141244758|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.117|TWO_SIDED|95.0|0.39|1.11|||Regression, Logistic|||||1.11|0.39|0.117
70879609|NCT00587483|141244758|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.433|TWO_SIDED|95.0|0.47|1.37|||Regression, Logistic|||||1.37|0.47|0.433
70879610|NCT00587483|141244759|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.215|TWO_SIDED|95.0|0.45|1.19|||Regression, Logistic|||||1.19|0.45|0.215
70879611|NCT00587483|141244759|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.51||||0.008|TWO_SIDED|95.0|0.32|0.84|||Regression, Logistic|||||0.84|0.32|0.008
70879612|NCT00587483|141244759|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.424|TWO_SIDED|95.0|0.52|1.33|||Regression, Logistic|||||1.33|0.52|0.424
70879613|NCT01046682|141244771|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Wilcoxon rank sum test|||Using data from a different population, ie, patients with peripheral artery disease, and a different intervention, ie, omega-3 fatty acids, 15 participants were needed per group to achieve 80% power to detect a difference in means of -3.6% (the difference between the control group mean of -0.3% and a treatment group mean of 3.3%) assuming a common standard deviation of 3.3 using a two group t-test with a 0.05 two-sided significance level. 5 patients added to each arm in case nonparametric.||||<0.05
70879614|NCT02246673|141244807|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-28.18|||<|0.0001|TWO_SIDED|95.0|-33.85|-22.51|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||-22.51|-33.85|<0.0001
70959321|NCT00706433|141422514|SUPERIORITY_OR_OTHER|||||||0.4814||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4814
70879615|NCT02246673|141244807|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-25.29|||<|0.0001|TWO_SIDED|95.0|-31.23|-19.34|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||-19.34|-31.23|<0.0001
70879616|NCT02246673|141244807|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-29.15|||<|0.0001|TWO_SIDED|95.0|-33.15|-25.15|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||-25.15|-33.15|<0.0001
70879617|NCT02246673|141244807|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-22.25|||<|0.0001|TWO_SIDED|95.0|-26.36|-18.14|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||-18.14|-26.36|<0.0001
70879618|NCT02246673|141244807|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-17.52|||<|0.0001|TWO_SIDED|95.0|-21.54|-13.5|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||-13.50|-21.54|<0.0001
70879619|NCT02246673|141244807|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-15.51|||<|0.0001|TWO_SIDED|95.0|-19.53|-11.49|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||-11.49|-19.53|<0.0001
70879620|NCT02246673|141244807|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-9.74|||<|0.0001|TWO_SIDED|95.0|-13.97|-5.51|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4||-5.51|-13.97|<0.0001
70879621|NCT02246673|141244807|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-4.98||||0.0221|TWO_SIDED|95.0|-9.19|-0.76|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect||Cohort 4||-0.76|-9.19|0.0221
70879622|NCT02246673|141244807|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-35.38|||<|0.0001|TWO_SIDED|95.0|-38.89|-31.87|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||-31.87|-38.89|<0.0001
70879623|NCT02246673|141244807|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-27.08|||<|0.0001|TWO_SIDED|95.0|-30.6|-23.57|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||-23.57|-30.60|<0.0001
70879624|NCT02246673|141244807|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-31.26|||<|0.0001|TWO_SIDED|95.0|-34.77|-27.75|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||-27.75|-34.77|<0.0001
70879625|NCT02246673|141244808|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|24.27||||0.0002|TWO_SIDED|95.0|12.57|35.98|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||35.98|12.57|0.0002
70879626|NCT02246673|141244808|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|20.08||||0.0013|TWO_SIDED|95.0|8.38|31.79|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||31.79|8.38|0.0013
70879627|NCT02246673|141244808|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|23.7|||<|0.0001|TWO_SIDED|95.0|14.23|33.17|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||33.17|14.23|<0.0001
70879628|NCT02246673|141244808|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|18.37||||0.0008|TWO_SIDED|95.0|8.3|28.44|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||28.44|8.30|0.0008
70879629|NCT02246673|141244808|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|18.82||||0.0101|TWO_SIDED|95.0|4.86|32.79|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||32.79|4.86|0.0101
70879630|NCT02246673|141244808|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|20.52||||0.0055|TWO_SIDED|95.0|6.56|34.48|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||34.48|6.56|0.0055
70879631|NCT02246673|141244808|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|10.36||||0.0065|TWO_SIDED|95.0|3.13|17.59|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4||17.59|3.13|0.0065
70879632|NCT02246673|141244808|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|1.79||||0.614|TWO_SIDED|95.0|-5.37|8.94|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect||Cohort 4||8.94|-5.37|0.6140
70879633|NCT02246673|141244808|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|30.83||||0.0002|TWO_SIDED|95.0|15.62|46.04|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||46.04|15.62|0.0002
70879634|NCT02246673|141244808|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|24.38||||0.0019|TWO_SIDED|95.0|9.63|39.14|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||39.14|9.63|0.0019
70879635|NCT02246673|141244808|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|26.35||||0.0009|TWO_SIDED|95.0|11.59|41.11|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||41.11|11.59|0.0009
70879636|NCT02246673|141244809|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|139.11|||<|0.0001|TWO_SIDED|95.0|93.92|184.31|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||184.31|93.92|<0.0001
70879637|NCT02246673|141244809|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|174.47|||<|0.0001|TWO_SIDED|95.0|125.52|233.42|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||233.42|125.52|<0.0001
70879638|NCT02246673|141244809|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|168.03|||<|0.0001|TWO_SIDED|95.0|123.13|212.93|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||212.93|123.13|<0.0001
70879639|NCT02246673|141244809|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|188.75|||<|0.0001|TWO_SIDED|95.0|138.04|239.46|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||239.46|138.04|<0.0001
70879640|NCT02246673|141244809|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|70.43||||0.0005|TWO_SIDED|95.0|33.74|107.12|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||107.12|33.74|0.0005
70879641|NCT02246673|141244809|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|91.5|||<|0.0001|TWO_SIDED|95.0|54.81|128.19|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||128.19|54.81|<0.0001
70879642|NCT02246673|141244809|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|40.11|||<|0.0001|TWO_SIDED|95.0|25.17|55.05|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4||55.05|25.17|<0.0001
70879643|NCT02246673|141244809|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|15.96||||0.035|TWO_SIDED|95.0|1.2|30.71|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4||30.71|1.20|0.0350
70959322|NCT00706433|141422515|SUPERIORITY_OR_OTHER|||||||0.7153||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.7153
70959323|NCT00706433|141422516|SUPERIORITY_OR_OTHER|||||||0.3832||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3832
70959324|NCT00706433|141422517|SUPERIORITY_OR_OTHER|||||||0.2908||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2908
70959325|NCT00706433|141422518|SUPERIORITY_OR_OTHER|||||||0.8096||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.8096
70959326|NCT00706433|141422519|SUPERIORITY_OR_OTHER|||||||0.308||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3080
70879644|NCT02246673|141244809|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|236.08|||<|0.0001|TWO_SIDED|95.0|178.29|293.86|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||293.86|178.29|<0.0001
70879645|NCT02246673|141244809|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|146.2|||<|0.0001|TWO_SIDED|95.0|90.4|202.01|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||202.01|90.40|<0.0001
70959327|NCT00706433|141422520|SUPERIORITY_OR_OTHER|||||||0.3208||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3208
70959328|NCT00706433|141422521|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
70959329|NCT00706433|141422522|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
70959330|NCT04426851|141422532|OTHER||Ratio of the geometric means (%)|45.9|||||TWO_SIDED|90.0|41.4|50.9|||||"Ratio was calculated as: BI 1358894 100 mg tablet fasted/BI 1358894 (C-14) 100 ug i.v.~Intra-individual geometric coefficient of variation (gCV)=14.3."|The Analysis of variance (ANOVA) model included effects accounting for the following sources of variation: 'subjects' and 'formulation'. The effect 'subjects' was considered as random, whereas 'formulation' was considered as fixed.||50.9|41.4|
70959331|NCT04426851|141422533|OTHER||Ratio of the geometric means (%)|141.4|||||TWO_SIDED|90.0|129.3|154.6|||||Ratio was calculated as: BI 1358894 100 mg oral suspension fed/BI 1358894 100 mg oral suspension fasted. Intra -individual geometric coefficient of variation (gCV)=10.9.|The ANOVA model included effects accounting for the following sources of variation: 'sequence or block', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||154.6|129.3|
70959332|NCT04426851|141422535|OTHER||Ratio of the geometric means (%)|65.3|||||TWO_SIDED|90.0|54.6|78.0|||||Ratio was calculated as: BI 1358894 100 mg oral suspension fed/BI 1358894 100 mg oral suspension fasted. Intra - individual geometric coefficient of variation (gCV)=22.5.|The ANOVA model included effects accounting for the following sources of variation: 'sequence or block', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||78.0|54.6|
70959333|NCT04426851|141422536|OTHER||Ratio of the geometric means (%)|148.4|||||TWO_SIDED|90.0|138.1|159.5|||||Ratio was calculated as: BI 1358894 100 mg oral suspension fed/BI 1358894 100 mg oral suspension fasted. Intra - individual geometric coefficient of variation (gCV) =8.7.|The ANOVA model included effects accounting for the following sources of variation: 'sequence or block', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||159.5|138.1|
70879646|NCT02246673|141244809|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|176.57|||<|0.0001|TWO_SIDED|95.0|120.77|232.38|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||232.38|120.77|<0.0001
70879647|NCT02246673|141244810|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|135.82|||<|0.0001|TWO_SIDED|95.0|93.33|178.32|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||178.32|93.33|<0.0001
70879648|NCT02246673|141244810|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|178.58|||<|0.0001|TWO_SIDED|95.0|129.25|227.9|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||227.90|129.25|<0.0001
70959334|NCT00825916|141422548|SUPERIORITY_OR_OTHER|||||||0.078||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.078
70959335|NCT00825916|141422548|SUPERIORITY_OR_OTHER|||||||0.086||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.086
70959336|NCT00825916|141422548|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.92
70879649|NCT02246673|141244810|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|163.98|||<|0.0001|TWO_SIDED|95.0|120.8|207.16|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||207.16|120.80|<0.0001
70879650|NCT02246673|141244810|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|169.93|||<|0.0001|TWO_SIDED|95.0|122.82|217.03|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||217.03|122.82|<0.0001
70879651|NCT02246673|141244810|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|59.6||||0.0007|TWO_SIDED|95.0|28.85|90.34|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||90.34|28.85|0.0007
70879652|NCT02246673|141244810|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|73.54|||<|0.0001|TWO_SIDED|95.0|42.79|104.28|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||104.28|42.79|<0.0001
70879653|NCT02246673|141244810|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|33.7|||<|0.0001|TWO_SIDED|95.0|21.21|46.2|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4||46.20|21.21|<0.0001
70879654|NCT02246673|141244810|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|27.08||||0.0001|TWO_SIDED|95.0|14.58|39.58|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4||39.58|14.58|0.0001
70879655|NCT02246673|141244810|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|188.83|||<|0.0001|TWO_SIDED|95.0|152.55|225.1|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||225.10|152.55|<0.0001
70879656|NCT02246673|141244810|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|116.83|||<|0.0001|TWO_SIDED|95.0|81.76|151.9|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||151.90|81.76|<0.0001
70879657|NCT02246673|141244810|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|151.66|||<|0.0001|TWO_SIDED|95.0|116.59|186.73|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||186.73|116.59|<0.0001
70879658|NCT00189228|141244870|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||95.0|||||t-test, 2 sided|||This is not a drug study.||||<0.01
70879659|NCT01265849|141244877|SUPERIORITY|||||||0.4051||||||For the primary efficacy measure a two-sided p-value of 0.05 or less is considered to be statistically significant in comparing the LI+CIZ+SOC treatment vs. SOC alone for superiority.|Log Rank|Log Rank statistic is based on an unstratified analysis.||The primary objective was to compare overall survival in the LI + CIZ + SOC group to that in the SOC alone group for superiority of the former.||||0.4051
70879660|NCT01265849|141244877|SUPERIORITY|||||||0.5402|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.5402
70879661|NCT01265849|141244877|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.4128|TWO_SIDED|95.0|0.89|1.32|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + CIZ + SOC.|||1.32|0.89|0.4128
70879662|NCT01265849|141244877|SUPERIORITY|||||||0.7181|||||||Log Rank|This Log Rank statistic is based on an unstratified analysis.||||||0.7181
70879663|NCT01265849|141244877|SUPERIORITY|||||||0.948|||||||Log Rank|This log Rank p-value is based on a stratified analysis.||||||0.9480
70879664|NCT01265849|141244877|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.6101|TWO_SIDED|95.0|0.81|1.42|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A hazard Ratio \< 1.0 would favor LI + SOC.|||1.42|0.81|0.6101
70879665|NCT01265849|141244878|SUPERIORITY|||||||0.0478|||||||Log Rank|This Log Rank statistic is based on an unstratified analysis.||||||0.0478
70879666|NCT01265849|141244878|SUPERIORITY|||||||0.0137|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.0137
70879667|NCT01265849|141244878|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0236|TWO_SIDED|95.0|0.48|0.95|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + CIZ + SOC.|||0.95|0.48|0.0236
70879668|NCT01265849|141244878|SUPERIORITY|||||||0.4115|||||||Log Rank|This Log Rank statistic is based on an unstratified analysis.||||||0.4115
70879669|NCT01265849|141244878|SUPERIORITY|||||||0.2862|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.|||This HR is presented as (LI + SOC) / SOC. A HR \< 1.0 favors LI+SOC. Wald p-value for this HR is 0.3859.|||0.2862
70879670|NCT01265849|141244878|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.3859|TWO_SIDED|95.0|0.52|1.29|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + SOC.|||1.29|0.52|0.3859
70879671|NCT01265849|141244879|SUPERIORITY|||||||0.7304||||||P-values are not adjusted for multiple comparisons.|Log Rank|This Log Rank P-value is based on an unstratified analysis.||The secondary endpoint LRC failure is analyzed similar to the primary OS endpoint. The primary comparison is LI+CIZ+SOC vs SOC; LI+SOC vs SOC results are also reported.||||0.7304
70879672|NCT01265849|141244879|SUPERIORITY|||||||0.7171||||||P-values are reported unadjusted for multiplicity.|Log Rank|The Log Rank statistic is based on a stratified analysis.||||||0.7171
70959337|NCT00825916|141422548|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.49
70959338|NCT00825916|141422549|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.74
70959339|NCT00825916|141422549|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.59
70959340|NCT00825916|141422549|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.69
70959341|NCT00825916|141422549|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||1.00
70959342|NCT00825916|141422550|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.34
70959343|NCT00825916|141422550|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.98
70959344|NCT00825916|141422550|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.15
70959345|NCT00825916|141422550|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.83
70959346|NCT00825916|141422550|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.95
70959347|NCT00825916|141422550|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.59
70879673|NCT01265849|141244879|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.802|TWO_SIDED|95.0|0.79|1.36|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + CIZ + SOC.|||1.36|0.79|0.8020
70879674|NCT01265849|141244879|SUPERIORITY|||||||0.4231|||||||Log Rank|The Log Rank statistic is based on an unstratified analysis.||||||0.4231
70879675|NCT01265849|141244879|SUPERIORITY|||||||0.6998|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.6998
70959348|NCT00825916|141422550|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.76
70959349|NCT00825916|141422550|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.63
70959350|NCT00825916|141422550|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.92
70959351|NCT00825916|141422550|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.69
70959352|NCT00825916|141422551|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED|95.0|||||Wilcoxon (signed rank)|For this early phase study, no adjustment was used.||||||0.95
70959353|NCT00825916|141422551|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED|95.0||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)|||||||0.76
70959354|NCT00825916|141422551|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED|95.0||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)|||||||0.60
70959355|NCT00825916|141422551|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED|95.0||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)|||||||0.44
70959356|NCT00825916|141422551|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED|95.0||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)|||||||0.85
70959357|NCT00825916|141422551|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|95.0||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)|||||||0.83
70959358|NCT01778023|141422552|SUPERIORITY_OR_OTHER||Treatment Difference|5.15|||<|0.0001|TWO_SIDED|95.0|4.09|6.21|||ANOVA|The HV after 6 months of treatment was analysed using an ANCOVA method with group and sex as fixed effects, and age as a covariate.||Let D be a mean difference of the primary endpoint between group A and group B. Null hypothesis H0: D = 0 vs. alternative H1: D ≠ 0 will be statistically tested by an ANOVA model.||6.21|4.09|<0.0001
70959359|NCT03086213|141422606|NON_INFERIORITY|the definition of non-inferiority analysis is that the new method is no less effective than standard interventions.|Mean Difference (Final Values)|10.0|STANDARD_DEVIATION|0.025||0.025|TWO_SIDED|95.0|5.0|95.0||whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance|t-test, 2 sided|degrees of freedom|Paravertebral nerve block arm represents the numerator and intercostal block represents the denominator for relative risk|null hypothesis||95|5|0.025
70879676|NCT01265849|141244879|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.3944|TWO_SIDED|95.0|0.81|1.69|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + SOC.|||1.69|0.81|0.3944
70879677|NCT01265849|141244880|SUPERIORITY|||||||0.6142|||||||Log Rank|The Log Rank statistic is based on an unstratified analysis.||||||0.6142
70879678|NCT01265849|141244880|SUPERIORITY|||||||0.3024|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.3024
70879679|NCT01265849|141244880|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.42082|TWO_SIDED|95.0|0.55|1.28|||Regression, Cox||A Hazard Ratio \< 1.0 would favor LI + CIZ + SOC.|||1.28|0.55|0.42082
70879680|NCT01265849|141244880|SUPERIORITY|||||||0.9784|||||||Log Rank|The Log Rank statistic is based on an unstratified analysis.||||||0.9784
70879681|NCT01265849|141244880|SUPERIORITY|||||||0.8461||||||This Log Rank statistic is based on a stratified analysis.|Log Rank|||||||0.8461
70879682|NCT01265849|141244880|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.8131|TWO_SIDED|95.0|0.53|1.65|||Regression, Cox||A Hazard Ratio of \< 1.0 would favor LI + SOC.|||1.65|0.53|0.8131
70879683|NCT01265849|141244881|SUPERIORITY|||||||0.3303|||||||Log Rank|This Log Rank statistic is from an unstratified analysis.||This secondary endpoint PFS is analyzed similar to OS and LRC.||||0.3303
70879684|NCT01265849|141244881|SUPERIORITY|||||||0.6669|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.6669
70879685|NCT01265849|141244881|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.3728|TWO_SIDED|95.0|0.9|1.31|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + CIZ + SOC.|||1.31|0.90|0.3728
70879686|NCT01265849|141244881|SUPERIORITY|||||||0.5739|||||||Log Rank|This Log Rank statistic is based on an unstratified analysis.||||||0.5739
70879687|NCT01265849|141244881|SUPERIORITY|||||||0.8162|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.8162
70879688|NCT01265849|141244881|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.4728|TWO_SIDED|95.0|0.84|1.43|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + SOC.|||1.43|0.84|0.4728
70879689|NCT01265849|141244882|SUPERIORITY|||||||0.1797|||||||Log Rank|This Log Rank statistic is based on an unstratified analysis.||||||0.1797
70879690|NCT01265849|141244882|SUPERIORITY|||||||0.0159|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.0159
70879691|NCT01265849|141244882|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0896|TWO_SIDED|95.0|0.55|1.04|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio of \< 1.0 would favor LI + CIZ + SOC.|||1.04|0.55|0.0896
70879692|NCT01265849|141244882|SUPERIORITY|||||||0.5175|||||||Log Rank|This Log Rank statistic is based on an unstratified analysis.||||||0.5175
70879693|NCT01265849|141244882|SUPERIORITY|||||||0.453|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.4530
70879694|NCT01265849|141244882|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.4376|TWO_SIDED|95.0|0.54|1.3|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + SOC.|||1.30|0.54|0.4376
70879695|NCT01265849|141244883|SUPERIORITY||Mean Difference (Net)|-3.0|STANDARD_ERROR_OF_MEAN|2.395||0.21|TWO_SIDED|||||This p-value for Long Term Follow-up at Month 2 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Positive value for the difference (Mean Difference (Net)) favors LI + CIZ + SOC.|Approximately 30% of participants completed the QOL instrument at first administration (Month2), thus the study did not have the power for QoL comparisons. These completer analyses are descriptive only.||||0.2100
70879696|NCT01265849|141244883|SUPERIORITY||Mean Difference (Net)|4.67|STANDARD_ERROR_OF_MEAN|3.401||0.1701|TWO_SIDED|||||This p-value for Long Term Follow-up at Month 2 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Positive value for the difference (Mean Difference (Net)) favors LI + SOC.|Approximately 30% of participants completed the QOL instrument at last administration (Month 36), thus the study did not have power for QoL comparisons. These completer analyses are descriptive only.||||0.1701
70879697|NCT01265849|141244884|SUPERIORITY|This p-value for Long Term Follow-up at Month 36 is not adjusted for multiplicity.|Median Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|2.397||0.5871|TWO_SIDED|||||This p-value for Long Term Follow-up at Month 36 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Positive value for the difference (Mean Difference (Net)) favors LI + CIZ + SOC.|LI + CIZ + SOC, Standard of Care (SOC)||||0.5871
70879698|NCT01265849|141244884|SUPERIORITY||Mean Difference (Net)|4.46|STANDARD_ERROR_OF_MEAN|3.247||0.17|TWO_SIDED|||||This p-value for Long Term Follow-up at Month 36 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Positive value for the difference (Mean Difference (Net)) favors LI + SOC.|||||0.1700
70879699|NCT01265849|141244885|SUPERIORITY||Mean Difference (Net)|1.05|STANDARD_ERROR_OF_MEAN|2.183||0.6296|TWO_SIDED|||||This p-value for head and neck pain at Long Term Follow-up Month 2 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed effects of treatment, visit, treatment by visit, tumor location \& stage, geographic region, and baseline with compound symmetry.|Negative value for the difference (Mean Difference (Net)) favors LI + CIZ + SOC.|||||0.6296
70879700|NCT01265849|141244885|SUPERIORITY||Mean Difference (Net)|1.01|STANDARD_ERROR_OF_MEAN|3.103||0.7454|TWO_SIDED|||||This p-value for head and neck pain at Long Term Follow-up Month 2 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed effects of treatment, visit, treatment by visit, tumor location \& stage, geographic region, and baseline with compound symmetry.|Negative value for the difference (Mean Difference (Net)) favors LI + SOC.|||||0.7454
70879701|NCT01265849|141244885|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|2.465||0.7452|TWO_SIDED|||||This p-value for Long Term Follow-up for swallowing at month 2 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed effects of treatment, visit, treatment by visit, tumor location \& stage, geographic region, and baseline with compound symmetry.|Negative value for the difference (Mean Difference (Net)) favors LI + CIZ + SOC.|||||0.7452
70959360|NCT03086213|141422607|SUPERIORITY|During the calculation of sample size,a sample size of 24 patients per group was calculated as being required to ensure 90% power of detecting the difference-if any-as statistically significant at the 5% level|||||<|0.05||||||the p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance.|t-test, 2 sided|degrees of freedom is defined as sample size subtraction one.||null hypothesis||||<0.05
70959361|NCT03086213|141422610|SUPERIORITY|During the calculation of sample size,a sample size of 24 patients per group was calculated as being required to ensure 90% power of detecting the difference-if any-as statistically significant at the 5% level||||||0.05|||||||t-test, 2 sided|Degree of freedom is defined as sample size subtraction one.||null hypothesis||||0.05
70879702|NCT01265849|141244885|SUPERIORITY||Mean Difference (Net)|-1.02|STANDARD_ERROR_OF_MEAN|3.496||0.771|TWO_SIDED|||||This p-value for Long Term Follow-up for swallowing at Month 2 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed effects of treatment, visit, treatment by visit, and baseline with compound symmetry.|Negative value for the difference (Mean Difference (Net)) favors LI + SOC.|||||0.7710
70879703|NCT01265849|141244886|SUPERIORITY||Mean Difference (Net)|-1.04|STANDARD_ERROR_OF_MEAN|2.185||0.6337|TWO_SIDED|||||This p-value for Long Term Follow-up for head and neck pain at Month 36 is not adjusted for multiplicity|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Negative value for the difference (Mean Difference (Net)) favors LI + CIZ + SOC.|||||0.6337
70879704|NCT01265849|141244886|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|2.962||0.945|TWO_SIDED|||||This p-value for Long Term Follow-up for head and neck pain at Month 36 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Negative value for the difference (Mean Difference (Net)) favors LI + SOC.|||||0.9450
70879705|NCT01265849|141244886|SUPERIORITY||Mean Difference (Net)|-2.04|STANDARD_ERROR_OF_MEAN|2.465||0.4071|TWO_SIDED|||||This p-value for Long Term Follow-up for Swallowing at Month 36 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Negative value for the difference (Mean Difference (Net)) favors LI+ CIZ + SOC.|||||0.4071
70879706|NCT01265849|141244886|SUPERIORITY||Mean Difference (Net)|-7.29|STANDARD_ERROR_OF_MEAN|3.347||0.0296|TWO_SIDED|||||This p-value for Long Term Follow-up for Swallowing at Month 36 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Negative value for the difference (Mean Difference (Net)) favors LI + SOC.|||||0.0296
70959362|NCT01616056|141422630|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
70959363|NCT01616056|141422632|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
70959364|NCT01616056|141422634|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
70959365|NCT01616056|141422637|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
70879707|NCT01265849|141244887|SUPERIORITY|Statistical tests were for a significant treatment effect in the Cox Proportional Hazards model including treatment, disease stage, tumor location, and geographical region.|% of significant test results|21.6|||<|0.05|TWO_SIDED|95.0|17.0|26.9||"Under the null hypothesis of no effect the expected number of significant test results would be balanced between treatments.~The expected number (%) of statistically significant results would be approximately 14 (5%) of 282."|Regression, Cox|||"Treatment comparisons of LI+CIZ+SOC v. SOC were repeated at all levels of HP, HP ratios, and HP combinations for endpoints OS, PFS, and LRC.~Significant outcomes for the treatment term in the model (two-sided p\<0.05) were accumulated."||26.9|17.0|<0.05
70879708|NCT01265849|141244888|SUPERIORITY||Percent (%) of Participants|8.1|||<|0.0001|TWO_SIDED|95.0|5.6|11.2|||Fisher Exact|||Null hypothesis is that percent (%) of participants with an objective response (CR+PR) is the same for LI + CIZ + SOC and SOC.||11.2|5.6|<.0001
70879709|NCT01265849|141244888|SUPERIORITY||Percent (%) of Participants|9.7|||<|0.0001|TWO_SIDED|95.0|4.7|14.7|||Fisher Exact|||Null hypothesis is that percent (%) of participants with an objective response (CR+PR) is the same for LI + SOC and SOC.||14.7|4.7|<0.0001
70879710|NCT01265849|141244889|SUPERIORITY||Percent (%) of Participants|15.2|||<|0.0001|TWO_SIDED|95.0|9.6|20.8|||Fisher Exact|||Null hypothesis is that percent (%) of participants with an objective response (CR+PR) is the same for LI + CIZ + SOC and SOC.||20.8|9.6|<0.0001
70879711|NCT01265849|141244889|SUPERIORITY||Percent (%) of Participants|18.5|||<|0.0001|TWO_SIDED|95.0|8.2|28.9|||Fisher Exact|||Null hypothesis is that percent (%) of participants with an objective response (CR+PR) is the same for LI + SOC and SOC.||28.9|8.2|<0.0001
70879712|NCT01265849|141244890|SUPERIORITY|||||||0.0007|||||||Fisher Exact|||The null hypothesis that survival is unrelated to objective response versus the alternative hypothesis that objective response is predictive of increased survival for participants receiving LI + CIZ + SOC.||||0.0007
70879713|NCT01265849|141244890|SUPERIORITY|||||||0.0434|||||||Fisher Exact|||The null hypothesis is that survival is unrelated to objective response versus the alternative that response is predictive of increased survival in subjects receiving LI + SOC.||||0.0434
70879714|NCT01265849|141244890|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||The null hypothesis is that survival is unrelated to objective response versus the alternative hypothesis that objective response is predictive of increased survival for participants receiving LI, considering both treatment groups combined.||||<0.0001
70879715|NCT01265849|141244891|SUPERIORITY|||||||0.0101|||||||Fisher Exact|||The null hypothesis that survival is unrelated to objective response versus the alternative hypothesis that objective response is predictive of increased survival for low risk participants receiving LI + CIZ + SOC.||||0.0101
70879716|NCT01265849|141244891|SUPERIORITY|||||||0.4843|||||||Fisher Exact|||The null hypothesis that survival is unrelated to objective response versus the alternative hypothesis that objective response is predictive of increased survival for low risk participants receiving LI + SOC.||||0.4843
70879717|NCT01265849|141244891|SUPERIORITY||||||<|0.0067||||||The null hypothesis is that survival is unrelated to objective response versus the alternative hypothesis that objective response is predictive of increased survival for participants receiving LI, considering both treatment groups combined.|Fisher Exact|||||||<0.0067
70879718|NCT01265849|141244892|SUPERIORITY||Hazard Ratio (HR)|0.348||||0.0131|TWO_SIDED|95.0|0.152|0.801|||Regression, Cox|||Null hypothesis is that the Hazard Ratio (HR) for low risk subjects responding to LI (combined arms LI + CIZ + SOC, LI + SOC) is \>=1.0 versus the alternative hypothesis that subjects responding to LI are at reduced risk of death (HR \< 1.0).||0.801|0.152|0.0131
70879719|NCT01265849|141244892|SUPERIORITY||Hazard Ratio (HR)|0.246||||0.0181|TWO_SIDED|95.0|0.077|0.787|||Regression, Cox|||Null hypothesis is that the Hazard Ratio (HR) for low risk subjects responding to LI + CIZ + SOC is \>=1.0 versus the alternative hypothesis that subjects responding to LI + CIZ + SOC are at reduced risk of death (HR \< 1.0).||0.787|0.077|0.0181
70879720|NCT01895855|141244897|SUPERIORITY|The lower, two sided 95% confidence bound on protective efficacy must be \>/= 30%.|Vaccine Efficacy|90.3|||||ONE_SIDED|95.1|62.7||||||Confidence intervals for the protective vaccine efficacy (PE) estimates were calculated using the method of Farrington and Manning (Farrington 1990).|35 participants were challenged 10 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.|||62.7|
70879721|NCT01895855|141244898|SUPERIORITY|The lower, two sided 95% confidence bound on protective efficacy must be \>/= 30%.|Vaccine Efficacy|79.5|||||ONE_SIDED|95.1|49.9||||||Confidence intervals for the protective vaccine efficacy (PE) estimates were calculated using the method of Farrington and Manning (Farrington 1990).|33 participants were challenged 90 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.|||49.9|
70879722|NCT01895855|141244899|SUPERIORITY|||||||0.0073|||||||Wilcoxon (Mann-Whitney)|||35 participants were challenged 10 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||0.0073
70879723|NCT01895855|141244900|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||33 participants were challenge 90 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||<0.0001
70879724|NCT01895855|141244901|SUPERIORITY||Vaccine Efficacy|84.5|||||TWO_SIDED|95.0|67.0|100.0|||||Confidence interval for the protective vaccine efficacy (PE) estimates were calculated using the method of Farrington and Manning (Farrington 1990).|35 participants were challenged 10 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||100.0|67.0|
70879725|NCT01895855|141244902|SUPERIORITY||Vaccine Efficacy|50.8|||||TWO_SIDED|95.0|33.6|66.8|||||Confidence interval for protective vaccine efficacy (PE) estimates were calculated using the method of Farrington and Manning (Farrington 1990).|33 participants were challenged 90 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||66.8|33.6|
70879726|NCT01895855|141244903|SUPERIORITY|||||||0.0025|||||||Fisher Exact|||35 participants were challenged 10 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||0.0025
70879727|NCT01895855|141244904|SUPERIORITY|||||||0.0159|||||||Fisher Exact|||33 participants were challenged 90 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||0.0159
70879728|NCT01895855|141244905|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||35 participants were challenged 10 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||<0.0001
70879729|NCT01895855|141244906|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||33 participants were challenged 90 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||<0.0001
70879730|NCT01895855|141244907|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||35 participants were challenged 10 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||<0.0001
70879731|NCT01895855|141244908|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||33 participants were challenged 90 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||<0.0001
70879732|NCT03255382|141244932|OTHER||Adjusted percentage difference|73.3|||<|0.001|TWO_SIDED|95.0|61.3|85.3|||Cochran-Mantel-Haenszel|||P-value was calculated from the Cochran-Mantel-Haenszel (CMH) test adjusted for strata (prior phototherapy \[yes/no\]).||85.3|61.3|< 0.001
70879733|NCT03255382|141244933|OTHER||Adjusted percentage difference|46.8|||<|0.001|TWO_SIDED|95.0|32.8|60.8|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||60.8|32.8|< 0.001
70879734|NCT03255382|141244934|OTHER||Adjusted percentage difference|63.4|||<|0.001|TWO_SIDED|95.0|50.2|76.6|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||76.6|50.2|< 0.001
70879735|NCT03255382|141244935|OTHER||Adjusted percentage difference|53.1|||<|0.001|TWO_SIDED|95.0|40.4|65.7|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||65.7|40.4|< 0.001
70879736|NCT03255382|141244936|OTHER||Adjusted percentage difference|39.6|||<|0.001|TWO_SIDED|95.0|27.3|51.9|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||51.9|27.3|< 0.001
70879737|NCT03255382|141244937|OTHER||Adjusted percentage difference|36.3|||<|0.001|TWO_SIDED|95.0|24.1|48.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||48.5|24.1|< 0.001
70879738|NCT03255382|141244938|OTHER||Adjusted percentage difference|46.4|||<|0.001|TWO_SIDED|95.0|33.7|59.0|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||59.0|33.7|< 0.001
70879739|NCT03255382|141244939|OTHER||Adjusted percentage difference|9.9||||0.047|TWO_SIDED|95.0|0.1|19.7|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||19.7|0.1|0.047
70879740|NCT03255382|141244940|OTHER||Adjusted percentage difference|66.6|||<|0.001|TWO_SIDED|95.0|53.8|79.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||79.5|53.8|< 0.001
70879741|NCT03255382|141244941|OTHER||Adjusted percentage difference|66.6|||<|0.001|TWO_SIDED|95.0|53.3|79.9|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||79.9|53.3|< 0.001
70879742|NCT03255382|141244942|OTHER||Adjusted percentage difference|66.6|||<|0.001|TWO_SIDED|95.0|53.8|79.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||79.5|53.8|< 0.001
70879743|NCT03255382|141244943|OTHER||Adjusted percentage difference|56.5|||<|0.001|TWO_SIDED|95.0|43.0|70.0|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||70.0|43.0|< 0.001
70879744|NCT03255382|141244944|OTHER||Adjusted percentage difference|64.8|||<|0.001|TWO_SIDED|95.0|52.5|77.2|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||77.2|52.5|< 0.001
70879745|NCT03255382|141244945|OTHER||Adjusted percentage difference|1.7||||0.392|TWO_SIDED|95.0|-2.1|5.4|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||5.4|-2.1|0.392
70879746|NCT03255382|141244946|OTHER||Adjusted percentage difference|36.6|||<|0.001|TWO_SIDED|95.0|23.8|49.3|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||49.3|23.8|< 0.001
70879747|NCT03255382|141244947|OTHER||Adjusted percentage difference|56.6|||<|0.001|TWO_SIDED|95.0|43.2|70.0|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||70.0|43.2|< 0.001
70879748|NCT03255382|141244948|OTHER||Adjusted percentage difference|64.9|||<|0.001|TWO_SIDED|95.0|51.5|78.3|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||78.3|51.5|< 0.001
70879749|NCT03255382|141244949|OTHER||Adjusted percentage difference|66.6|||<|0.001|TWO_SIDED|95.0|53.3|79.8|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||79.8|53.3|< 0.001
70879750|NCT03255382|141244950|OTHER||Adjusted percentage difference|0.0||||0.991|TWO_SIDED|95.0|-2.0|2.1|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||2.1|-2.0|0.991
70879751|NCT03255382|141244951|OTHER||Adjusted percentage difference|3.3||||0.323|TWO_SIDED|95.0|-3.2|9.8|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||9.8|-3.2|0.323
70879752|NCT03255382|141244952|OTHER||Adjusted percentage difference|21.5|||<|0.001|TWO_SIDED|95.0|10.4|32.6|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||32.6|10.4|< 0.001
70879753|NCT03255382|141244953|OTHER||Adjusted percentage difference|33.1|||<|0.001|TWO_SIDED|95.0|20.7|45.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||45.5|20.7|< 0.001
70879754|NCT03255382|141244954|OTHER||Adjusted percentage difference|41.3|||<|0.001|TWO_SIDED|95.0|27.3|55.3|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||55.3|27.3|< 0.001
70879755|NCT03255382|141244955|OTHER||Adjusted percentage difference|44.7|||<|0.001|TWO_SIDED|95.0|30.9|58.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||58.5|30.9|< 0.001
70879756|NCT03255382|141244956|OTHER||Least Squares Mean Difference|-7.19|STANDARD_ERROR_OF_MEAN|0.825|<|0.001|TWO_SIDED|95.0|-8.82|-5.56|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and the treatment in this model.||-5.56|-8.82|< 0.001
70879757|NCT03255382|141244957|OTHER||Least Squares Mean Difference|-9.58|STANDARD_ERROR_OF_MEAN|0.936|<|0.001|TWO_SIDED|95.0|-11.43|-7.72|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-7.72|-11.43|< 0.001
70879758|NCT03255382|141244958|OTHER||Least Squares Mean Difference|-8.8|STANDARD_ERROR_OF_MEAN|0.972|<|0.001|TWO_SIDED|95.0|-10.72|-6.87|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-6.87|-10.72|< 0.001
70879759|NCT03255382|141244959|OTHER||Least Squares Mean Difference|-7.78|STANDARD_ERROR_OF_MEAN|0.958|<|0.001|TWO_SIDED|95.0|-9.68|-5.88|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-5.88|-9.68|< 0.001
70879760|NCT03255382|141244960|OTHER||Least Squares Mean Difference|-7.89|STANDARD_ERROR_OF_MEAN|1.101|<|0.001|TWO_SIDED|95.0|-10.07|-5.71|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-5.71|-10.07|< 0.001
70879761|NCT03255382|141244961|OTHER||Least Squares Mean Difference|-8.39|STANDARD_ERROR_OF_MEAN|1.175|<|0.001|TWO_SIDED|95.0|-10.71|-6.06|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-6.06|-10.71|< 0.001
70879762|NCT03255382|141244962|OTHER||Adjusted percentage difference|29.7|||<|0.001|TWO_SIDED|95.0|17.1|42.4|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||42.4|17.1|< 0.001
70879763|NCT03255382|141244963|OTHER||Adjusted percentage difference|66.7|||<|0.001|TWO_SIDED|95.0|53.4|80.0|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||80.0|53.4|< 0.001
70879764|NCT03255382|141244964|OTHER||Adjusted percentage difference|56.8|||<|0.001|TWO_SIDED|95.0|42.7|70.8|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||70.8|42.7|< 0.001
70879765|NCT03255382|141244965|OTHER||Adjusted percentage difference|59.9|||<|0.001|TWO_SIDED|95.0|46.3|73.6|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||73.6|46.3|< 0.001
70879766|NCT03255382|141244966|OTHER||Adjusted percentage difference|44.9|||<|0.001|TWO_SIDED|95.0|30.8|59.1|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||59.1|30.8|< 0.001
70879767|NCT03255382|141244967|OTHER||Adjusted percentage difference|55.0|||<|0.001|TWO_SIDED|95.0|41.2|68.8|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||68.8|41.2|< 0.001
70879768|NCT03255382|141244968|OTHER||Adjusted percentage difference|1.7||||0.392|TWO_SIDED|95.0|-2.1|5.4|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||5.4|-2.1|0.392
70879769|NCT03255382|141244969|OTHER||Adjusted percentage difference|8.4||||0.048|TWO_SIDED|95.0|0.1|16.7|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||16.7|0.1|0.048
70879770|NCT03255382|141244970|OTHER||Adjusted percentage difference|18.3||||0.001|TWO_SIDED|95.0|7.1|29.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||29.5|7.1|0.001
70879771|NCT03255382|141244971|OTHER||Adjusted percentage difference|33.0|||<|0.001|TWO_SIDED|95.0|20.2|45.9|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||45.9|20.2|< 0.001
70879772|NCT03255382|141244972|OTHER||Adjusted percentage difference|41.3|||<|0.001|TWO_SIDED|95.0|27.3|55.3|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||55.3|27.3|< 0.001
70879773|NCT03255382|141244973|OTHER||Adjusted percentage difference|46.4|||<|0.001|TWO_SIDED|95.0|32.6|60.1|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||60.1|32.6|< 0.001
70879774|NCT03255382|141244974|OTHER||Adjusted percentage difference|19.8||||0.001|TWO_SIDED|95.0|7.6|31.9|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||31.9|7.6|0.001
70879775|NCT03255382|141244975|OTHER||Adjusted percentage difference|38.3|||<|0.001|TWO_SIDED|95.0|25.0|51.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||51.5|25.0|< 0.001
70879776|NCT03255382|141244976|OTHER||Least Squares Mean Difference|-3.2|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|-4.5|-2.0|||van Elteren test|||P-values were calculated by stratified van Elteren test.||-2.0|-4.5|< 0.001
70879777|NCT03255382|141244977|OTHER||Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|-5.1|-2.7|||van Elteren test|||P-values were calculated by stratified van Elteren test.||-2.7|-5.1|< 0.001
70879778|NCT03255382|141244978|OTHER||Least Squares Mean Difference|1.146|||<|0.001|TWO_SIDED|95.0|0.764|1.528|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||1.528|0.764|< 0.001
70879779|NCT03255382|141244979|OTHER||Least Squares Mean Difference|1.32|||<|0.001|TWO_SIDED|95.0|0.936|1.704|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||1.704|0.936|< 0.001
70879780|NCT03255382|141244980|OTHER||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|-3.6|-1.1|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-1.1|-3.6|< 0.001
70879781|NCT03255382|141244981|OTHER||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.66|<|0.001|TWO_SIDED|95.0|-4.3|-1.6|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-1.6|-4.3|< 0.001
70879782|NCT03255382|141244982|OTHER||Least Squares Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.307||0.352|TWO_SIDED|95.0|-0.9|0.32|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||0.32|-0.90|0.352
70879783|NCT03255382|141244983|OTHER||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.296||0.315|TWO_SIDED|95.0|-0.88|0.29|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||0.29|-0.88|0.315
70879784|NCT03255382|141244984|OTHER||Least Squares Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|1.06|<|0.001|TWO_SIDED|95.0|-6.9|-2.7|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-2.7|-6.9|< 0.001
70879785|NCT03255382|141244985|OTHER||Least Squares Mean Difference|-9.3|STANDARD_ERROR_OF_MEAN|1.64|<|0.001|TWO_SIDED|95.0|-12.6|-6.1|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-6.1|-12.6|< 0.001
70879786|NCT03255382|141244986|OTHER||Least Squares Mean Difference|-10.2|STANDARD_ERROR_OF_MEAN|1.51|<|0.001|TWO_SIDED|95.0|-13.2|-7.2|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-7.2|-13.2|< 0.001
70879787|NCT03255382|141244987|OTHER||Least Squares Mean Difference|-9.8|STANDARD_ERROR_OF_MEAN|1.51|<|0.001|TWO_SIDED|95.0|-12.8|-6.8|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-6.8|-12.8|< 0.001
70879788|NCT03255382|141244988|OTHER||Least Squares Mean Difference|-9.6|STANDARD_ERROR_OF_MEAN|1.39|<|0.001|TWO_SIDED|95.0|-12.4|-6.8|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-6.8|-12.4|< 0.001
70879789|NCT03255382|141244989|OTHER||Least Squares Mean Difference|-10.0|STANDARD_ERROR_OF_MEAN|1.47|<|0.001|TWO_SIDED|95.0|-12.9|-7.1|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-7.1|-12.9|< 0.001
70879790|NCT03255382|141244990|OTHER||Least Squares Mean Difference|4.49|STANDARD_ERROR_OF_MEAN|1.385||0.002|TWO_SIDED|95.0|1.74|7.23|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||7.23|1.74|0.002
70879791|NCT03255382|141244991|OTHER||Least Squares Mean Difference|4.63|STANDARD_ERROR_OF_MEAN|1.322|<|0.001|TWO_SIDED|95.0|2.01|7.25|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||7.25|2.01|< 0.001
70879792|NCT03255382|141244992|OTHER||Least Squares Mean Difference|6.66|STANDARD_ERROR_OF_MEAN|1.787|<|0.001|TWO_SIDED|95.0|3.11|10.2|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||10.20|3.11|< 0.001
70879793|NCT03255382|141244993|OTHER||Least Squares Mean Difference|7.85|STANDARD_ERROR_OF_MEAN|1.784|<|0.001|TWO_SIDED|95.0|4.31|11.38|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||11.38|4.31|< 0.001
70879794|NCT03255382|141244994|OTHER||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.2|-0.7|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-0.7|-1.2|< 0.001
70879795|NCT03255382|141244995|OTHER||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.3|-0.8|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-0.8|-1.3|< 0.001
70879796|NCT03255382|141244996|OTHER||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|95.0|-3.2|-0.9|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-0.9|-3.2|< 0.001
70879797|NCT03255382|141244997|OTHER||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|-3.5|-1.1|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-1.1|-3.5|< 0.001
70879798|NCT03255382|141244998|OTHER||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|0.61|<|0.001|TWO_SIDED|95.0|-4.3|-1.9|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-1.9|-4.3|< 0.001
70879799|NCT03255382|141244999|OTHER||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|-4.4|-1.8|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-1.8|-4.4|< 0.001
70879800|NCT03255382|141245000|OTHER||Adjusted percentage difference|38.3|||<|0.001|TWO_SIDED|95.0|23.6|53.1|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||53.1|23.6|< 0.001
70879801|NCT03255382|141245001|OTHER||Adjusted percentage difference|56.8|||<|0.001|TWO_SIDED|95.0|42.7|70.9|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||70.9|42.7|< 0.001
70879802|NCT03255382|141245002|OTHER||Least Squares Mean Difference|-7.4|STANDARD_ERROR_OF_MEAN|1.15|<|0.001|TWO_SIDED|95.0|-9.6|-5.1|||ANCOVA|||P-values were calculated using ANCOVA with prior phototherapy (yes/no), baseline value, and treatment in the model.||-5.1|-9.6|< 0.001
70879803|NCT03255382|141245003|OTHER||Least Squares Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|1.06|<|0.001|TWO_SIDED|95.0|-9.7|-5.5|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-5.5|-9.7|< 0.001
70879804|NCT03255382|141245004|OTHER||Least Squares Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|1.23|<|0.001|TWO_SIDED|95.0|-9.0|-4.1|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-4.1|-9.0|< 0.001
70879805|NCT03255382|141245005|OTHER||Least Squares Mean Difference|-8.1|STANDARD_ERROR_OF_MEAN|1.53|<|0.001|TWO_SIDED|95.0|-11.1|-5.0|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-5.0|-11.1|< 0.001
70879806|NCT03255382|141245006|OTHER||Least Squares Mean Difference|0.087|STANDARD_ERROR_OF_MEAN|0.0215|<|0.001|TWO_SIDED|95.0|0.045|0.13|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||0.130|0.045|< 0.001
70879807|NCT03255382|141245007|OTHER||Least Squares Mean Difference|0.059|STANDARD_ERROR_OF_MEAN|0.0186||0.002|TWO_SIDED|95.0|0.022|0.096|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||0.096|0.022|0.002
70879808|NCT03255382|141245008|OTHER||Least Squares Mean Difference|14.9|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|9.4|20.5|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||20.5|9.4|< 0.001
70879809|NCT03255382|141245009|OTHER||Least Squares Mean Difference|16.8|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|11.4|22.2|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||22.2|11.4|< 0.001
70879810|NCT03255382|141245010|OTHER||Least Squares Mean Difference|-11.4|STANDARD_ERROR_OF_MEAN|2.64|<|0.001|TWO_SIDED|95.0|-16.6|-6.2|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and the treatment in this model.||-6.2|-16.6|< 0.001
70879811|NCT03255382|141245011|OTHER||Least Squares Mean Difference|-13.7|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-19.1|-8.4|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and the treatment in this model.||-8.4|-19.1|< 0.001
70879812|NCT03255382|141245012|OTHER||Least Squares Mean Difference|-17.3|STANDARD_ERROR_OF_MEAN|3.75|<|0.001|TWO_SIDED|95.0|-24.8|-9.8|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and the treatment in this model.||-9.8|-24.8|< 0.001
70879813|NCT03255382|141245013|OTHER||Least Squares Mean Difference|-21.5|STANDARD_ERROR_OF_MEAN|3.66|<|0.001|TWO_SIDED|95.0|-28.8|-14.2|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and the treatment in this model.||-14.2|-28.8|< 0.001
70879814|NCT03011307|141245023|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Intercept Difference in score on a scale|0.1||||0.75|TWO_SIDED|95.0|0.0|0.2||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||.2|0|0.75
70959366|NCT01831856|141422646|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.5749|TWO_SIDED|95.0|0.71|1.85|||Log Rank|||The primary criterion, time to first Atrial Fibrillation (AF) recurrence or atrial flutter emergence, was described using survival curves according to the Kaplan-Meier method, reporting the first and third quartiles (Q1, Q3), median, and 95% confidence interval. The time to first AF recurrence or atrial flutter emergence was compared between treatment groups using the Log rank test. Hazard ratios and 95% confidence intervals were estimated with the Cox regression model.||1.85|0.71|0.5749
70959367|NCT02294227|141422660|SUPERIORITY||Odds Ratio (OR)|3.07||||0.0002|TWO_SIDED|95.0|1.66|5.66|||Chi-squared|||||5.66|1.66|0.0002
70879815|NCT03011307|141245024|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Slope Difference|0.1||||0.057|TWO_SIDED|95.0|0.0|0.2||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||0.2|0.0|0.057
70879816|NCT03011307|141245025|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Intercept Difference in Daily Steps|-402.0||||0.41|TWO_SIDED|95.0|-1358.0|553.0||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||553|-1358|0.41
70879817|NCT03011307|141245026|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Mean Difference (Final Values)|344.0|||<|0.001|TWO_SIDED|95.0|173.0|515.0||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Slope Difference|||"The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.~The slope is the number of daily steps divided by the natural log of time in days."||515|173|<0.001
70959368|NCT02294227|141422660|SUPERIORITY||Odds Ratio (OR)|3.24||||0.0003|TWO_SIDED|95.0|1.76|5.97|||Chi-squared, Corrected|||||5.97|1.76|0.0003
70959369|NCT00887432|141422669|SUPERIORITY||Mean Difference (Net)|0.24||||0.431|TWO_SIDED|95.0|-0.36|0.84||Significance level of 0.05.|t-test, 2 sided|Paired t-test, df=86||Evaluated the change in PSA under the vitamin D and placebo conditions using the combined data (n=87).||0.84|-0.36|0.431
70959370|NCT00887432|141422670|SUPERIORITY|Comparing the mean PSA slopes between conditions (on vitamin D versus on placebo).|Mean Difference (Net)|-0.00019||||0.112|TWO_SIDED|95.0|-0.00042|0.000045||Significance level of 0.05.|Mixed Models Analysis|||||0.000045|-0.00042|0.112
70959371|NCT01209780|141422688|NON_INFERIORITY_OR_EQUIVALENCE|The investigational TIV was to be considered non-inferior to the control TIV if for all three strains the upper bound of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion control - Seroconversion investigational) at 21 days after last vaccination does not exceed 10 percentage points.|Vaccine group difference (%)|-1.0|||||TWO_SIDED|95.0|-4.0|2.0||||||Non-inferiority of investigational TIV to control TIV against A/H1N1 influenza strain||2|-4|
70959372|NCT01209780|141422688|NON_INFERIORITY_OR_EQUIVALENCE|The investigational TIV was to be considered non-inferior to the control TIV if, for all three strains, the upper bound of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion control - Seroconversion investigational), at 21 days after last vaccination, does not exceed 10 percentage points|Vaccine group difference (%)|10.0|||||TWO_SIDED|95.0|6.0|14.0||||||Non-inferiority of investigational TIV to control TIV against A/H3N2 influenza strain||14|6|
70959373|NCT01209780|141422688|NON_INFERIORITY_OR_EQUIVALENCE|The investigational TIV was to be considered non-inferior to the control TIV if, for all three strains, the upper bound of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion control - Seroconversion investigational), at 21 days after last vaccination, does not exceed 10 percentage points|Vaccine group difference (%)|-1.0|||||TWO_SIDED|95.0|-5.0|3.0||||||Non-inferiority of investigational TIV to the control TIV against B influenza strain||3|-5|
70879818|NCT03011307|141245027|SUPERIORITY|A likelihood-ratio test for change in World Health Organization Disability Assessment Score 2.0 value was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Intercept Difference: score on a scale|-5.9||||0.002|TWO_SIDED|95.0|-9.5|-2.3||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline World Health Organization Disability Assessment Score 2.0 value, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||-2.3|-9.5|0.002
70879819|NCT03011307|141245028|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Slope Difference|1.5||||0.001|TWO_SIDED|95.0|0.6|2.4||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||2.4|0.6|0.001
70879820|NCT03011307|141245029|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Mean Difference (Final Values)|0.00035||||0.537|TWO_SIDED|95.0|-0.00085|0.0015||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Intercept difference: Opioid probability|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||.0015|-.00085|0.537
70879821|NCT03011307|141245030|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Slope Difference: Opioid probability|-0.166||||0.01|TWO_SIDED|95.0|-0.172|-0.16||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||-0.160|-0.172|0.010
70879822|NCT03011307|141245031|SUPERIORITY||Mean Difference (Net)|3.0|STANDARD_DEVIATION|14.0||0.55|TWO_SIDED||||||Regression, Linear|||Scores were compared statistically at baseline and 2 months between groups using a generalized linear model with time as a fixed factor.||||.55
70879823|NCT03011307|141245032|SUPERIORITY||Mean Difference (Net)|1.2|STANDARD_DEVIATION|2.2||0.46|TWO_SIDED||||||Regression, Linear|||Groups were compared over time from baseline to 2 months using a generalized linear model with time as a fixed factor.||||0.46
70879824|NCT03011307|141245033|SUPERIORITY||Mean Difference (Final Values)|0.24|STANDARD_DEVIATION|0.84||0.38|TWO_SIDED||||||Regression, Linear|||Groups were compared between preoperative and 2 month postoperative sessions using linear regression with time as a fixed factor.||||0.38
70879825|NCT00651755|141245052|NON_INFERIORITY_OR_EQUIVALENCE|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|Ratio Geometric Mean AUC|1.2|||||TWO_SIDED|90.0|1.08|1.33|||90% CI||Ratio Geometric Mean AUC (Area Under Curve) of Analyte,CP, between Aprepitant treatment to control Group.|||1.33|1.08|
70879826|NCT00651755|141245053|NON_INFERIORITY_OR_EQUIVALENCE|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|ratio Geometric mean AUC|0.75|STANDARD_DEVIATION|0.29|||TWO_SIDED|95.0|0.65|0.86|||equivalence analysis||The geometric mean AUC ratio is the ratio of geometric mean AUC between aprepitant treatment and the control group|||0.86|0.65|
70879827|NCT00651755|141245054|NON_INFERIORITY_OR_EQUIVALENCE|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|Ratio Geometric Mean AUC|0.97|STANDARD_DEVIATION|0.35|||TWO_SIDED|90.0|0.83|1.13|||equivalence analysis|The geometric mean AUC ratio is the ratio of geometric mean AUC between aprepitant treatment to the control group|Ratio Geometric Mean AUC of Analyte, 4-OHCP, between Aprepitant treatment to control Group|||1.13|0.83|
70879828|NCT00651755|141245055|NON_INFERIORITY_OR_EQUIVALENCE|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|Ratio Geometric Mean AUC|1.04|STANDARD_DEVIATION|0.68|||TWO_SIDED|90.0|0.82|1.33|||equivalence analysis||Ratio Geometric Mean AUC (Area Under Curve) of Analyte, VC, Between Aprepitant treatment to control Group.|||1.33|0.82|
70879829|NCT00651755|141245056|NON_INFERIORITY_OR_EQUIVALENCE|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|Ratio Geometric Mean AUC|1.08|STANDARD_DEVIATION|0.17||||90.0|1.02|1.15|||equivalence analysis||The geometric mean AUC ratio is the ratio of geometric mean AUC between aprepitant treatment and the control group.|||1.15|1.02|
70959374|NCT01209780|141422690|NON_INFERIORITY_OR_EQUIVALENCE|The investigational TIV was to be considered non-inferior to the control TIV, if for all three strains, the upper bound of the two-sided 95% CI on the ratio of the GMTs (GMTcontrol/GMTinvestigational) at 21 days after last vaccination does not exceed 1.5|Ratio of GMTs|1.32|||||TWO_SIDED|95.0|1.11|1.56||||||Non-inferiority of investigational TIV to licensed control TIV against A/H1N1 influenza strain||1.56|1.11|
70959375|NCT01209780|141422690|NON_INFERIORITY_OR_EQUIVALENCE|The investigational TIV was to be considered non-inferior to the control TIV, if for all three strains, the upper bound of the two-sided 95% CI on the ratio of the GMTs (GMTcontrol/GMTinvestigational) at 21 days after last vaccination does not exceed 1.5|Ratio of GMTs|1.48|||||TWO_SIDED|95.0|1.34|1.64||||||Non-inferiority of investigational TIV to licensed control TIV against A/H3N2 influenza strain||1.64|1.34|
70959376|NCT01209780|141422690|NON_INFERIORITY_OR_EQUIVALENCE|The investigational TIV was to be considered non-inferior to the control TIV, if for all three strains, the upper bound of the two-sided 95% CI on the ratio of the GMTs (GMTcontrol/GMTinvestigational) at 21 days after last vaccination does not exceed 1.5|Ratio of GMTs|0.95|||||TWO_SIDED|95.0|0.85|1.07||||||Non-inferiority of investigational TIV to licensed control TIV against B influenza strain||1.07|0.85|
70959377|NCT05007808|141422700|SUPERIORITY|ANCOVA model with Change from Baseline to Week 4/EOT as the outcome (dependent) variable, treatment as the independent variable, and baseline score as covariate. The p-value was derived from the t-test for the comparison of adjusted LS means between the treatment groups.|LS Mean Difference|-0.19||||0.6742|TWO_SIDED|95.0|-1.081|0.701|||t-test, 2 sided|||||0.701|-1.081|0.6742
70959378|NCT00511472|141422736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.1|STANDARD_ERROR_OF_MEAN|14.15||0.001|TWO_SIDED|90.0|22.71|69.5|||ANOVA|||For the least square mean difference - baseline in the ANOVA model = glucose value at Titration Day 1 pre-Breakfast for Titration Group 1||69.50|22.71|0.001
70959379|NCT00511472|141422736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.28|STANDARD_ERROR_OF_MEAN|13.67|<|0.001|TWO_SIDED|90.0|27.68|72.88|||ANOVA|||For the least square mean difference - baseline in the ANOVA model = glucose value at Titration Day 1 pre-breakfast for Titration Group 2||72.88|27.68|<0.001
70959380|NCT00731120|141422750|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.803||0.279|TWO_SIDED|95.0|-2.45|0.71||Hierarchical testing stopped at 10 mg versus placebo for HAM-A total score at Week 8 in the testing sequence, a nominal p-value is provided.|ANCOVA|Analysis of covariance (ANCOVA), with treatment and center as fixed factors and baseline HAM-A as a covariate.||P-values were tested at the 5% significance level (ie, statistical significance if P\<0.05). To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 2.5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.05, the testing procedure stopped for all subsequent endpoints.||0.71|-2.45|0.279
70959381|NCT00731120|141422750|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.791||0.306|TWO_SIDED|95.0|-2.36|0.74||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.05, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|ANCOVA|Analysis of covariance (ANCOVA), with treatment and center as fixed factors and baseline HAM-A as a covariate.||||0.74|-2.36|0.306
70959382|NCT01551212|141422760|SUPERIORITY||Mean Difference (Final Values)|4.09||||0.097|TWO_SIDED|95.0|-0.74|8.91|||ANCOVA|factors: treatment, center, HCV-Class (positive, negative) and lab MELD (≤ 30 vs \> 30) covariate: baseline value||||8.91|-0.74|0.097
70959383|NCT01551212|141422761|SUPERIORITY||Mean Difference (Final Values)|7.99||||0.0085|TWO_SIDED|95.0|2.06|13.92|||ANCOVA|factors: treatment, center, HCV-Class (positive, negative) and lab MELD (≤ 30 vs \> 30) covariate: baseline value||||13.92|2.06|0.0085
70959384|NCT01551212|141422762|SUPERIORITY|||||||0.699|||||||Fisher Exact|||||||0.699
70959385|NCT00529958|141422768|EQUIVALENCE|The sample size calculation was based on 88 ACL-deficient patients with surgical intervention and an ACL-QOL score of 74.5 (SD=20.1) at a mean 39-month follow-up, a minimal clinically important difference of 10 points, power=0.80 and p=0.05.|||||<|0.05||||||A Bonferroni adjustment for multiple comparisons was used in the sample size calculation, resulting in 90 patients per group. With a 20% lost-to-follow-up rate, the final sample size was 108 patients per group for a total of 324 patients.|Mixed Models Analysis|||"All patients were analyzed on an intention-to-treat basis using a 5% significance level for all analyses. The ACL-QOL scores for each study group were analyzed using adjusted Bonferroni comparisons and repeated-measures analyses, using a mixed-model analysis of variance for treatment group over time of assessment."||||<0.05
70959386|NCT03534284|141422788|SUPERIORITY|||||||0.6761||||||0.05 threshold for significance; no adjustment for multiple comparisons|Mixed Models Analysis|||Null hypothesis: average CBT-I=Trazodone=Placebo at week 7||||0.6761
70959387|NCT03534284|141422789|SUPERIORITY|||||||0.8375|||||||Mixed Models Analysis|||Null hypothesis: average CBT-I=Trazodone=Placebo at week 25||||0.8375
70959388|NCT03316300|141422812|SUPERIORITY||Mean Difference (Final Values)|-0.091|STANDARD_ERROR_OF_MEAN|0.0176|<|0.0001|TWO_SIDED|95.0|-0.13|-0.06|||Mixed Models Analysis|||||-0.06|-0.13|<0.0001
70959389|NCT04737187|141422815|SUPERIORITY||Hazard Ratio (HR)|0.61|||<|0.001|TWO_SIDED|95.0|0.49|0.77||Stratified log-rank test, with a target p-value \< 0.025 for level of significance.|Stratified log-rank test||Hazard ratio and 95% confidence interval was estimated with stratified Cox proportional hazard model.|Overall Survival Median analysis: The primary estimand was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy).||0.77|0.49|< 0.001
70959390|NCT04737187|141422819|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.001|TWO_SIDED|95.0|0.36|0.54||Stratified log-rank test, with a target p-value \< 0.025 for level of significance.|Stratified log-rank test||Hazard ratio and 95% confidence interval was estimated with stratified Cox proportional hazard model.|PFS Median analysis: A hierarchical testing method was used to control type I error and handle key secondary endpoint analysis. When the primary outcome measure significant testing was then performed sequentially on the key secondary outcome measure. statistically significant at 0.05 level.||0.54|0.36|< 0.001
70959391|NCT03756129|141422828|SUPERIORITY||Median Difference (Net)|-8.25||||0.0013|TWO_SIDED|80.0|-11.67|-4.83|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: Pooled MIJ821 0.16 mg/kg minus placebo. The MIJ821 treatment arms vs placebo are primary."||-4.83|-11.67|0.0013
70959392|NCT03756129|141422828|SUPERIORITY||Mean Difference (Net)|-5.71||||0.0196|TWO_SIDED|80.0|-9.22|-2.2|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: Pooled MIJ821 0.32 mg/kg minus placebo. The MIJ821 treatment arms vs placebo are primary."||-2.20|-9.22|0.0196
70959393|NCT03756129|141422829|SUPERIORITY||Mean Difference (Net)|-7.06||||0.013|TWO_SIDED|80.0|-11.06|-3.06|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: Pooled MIJ821 0.16 mg/kg minus placebo."||-3.06|-11.06|0.0130
70959394|NCT03756129|141422829|SUPERIORITY||Median Difference (Net)|-7.37||||0.0133|TWO_SIDED|80.0|-11.57|-3.18|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: Pooled MIJ821 0.32 mg/kg minus placebo."||-3.18|-11.57|0.0133
70879830|NCT00651755|141245057|NON_INFERIORITY_OR_EQUIVALENCE|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|Ratio Geometric Mean AUC|1.16|STANDARD_DEVIATION|0.47|||TWO_SIDED|90.0|1.01|1.32|||equivalence analysis||Ratio Geometric Mean AUC (Area Under Curve) of Analyte,PL, Between Aprepitant treatment to control Group.|||1.32|1.01|
70879831|NCT00624052|141245058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||||95.0|0.47|1.66|||Cochran-Mantel-Haenszel|||||1.66|0.47|
70879832|NCT00624052|141245058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.28||||||95.0|0.14|0.59|||Cochran-Mantel-Haenszel|||||0.59|0.14|
70879833|NCT00624052|141245058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.24||||||95.0|0.12|0.48|||Cochran-Mantel-Haenszel|||||0.48|0.12|
70879834|NCT00624052|141245058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32||||||95.0|0.17|0.59|||Cochran-Mantel-Haenszel|||||0.59|0.17|
70879835|NCT00624052|141245058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||||95.0|0.15|0.49|||Cochran-Mantel-Haenszel|||||0.49|0.15|
70879836|NCT00624052|141245058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||||95.0|0.42|1.68|||Cochran-Mantel-Haenszel|||||1.68|0.42|
70879837|NCT03760146|141245111|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the geometric mean ratio (GMR) for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.8|||||TWO_SIDED|95.0|0.71|0.9||||||Serotype 1: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.90|0.71|
70879838|NCT03760146|141245111|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.85|||||TWO_SIDED|95.0|0.78|0.93||||||Serotype 3: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.93|0.78|
70959395|NCT03756129|141422830|SUPERIORITY||Mean Difference (Net)|-5.09||||0.1082|TWO_SIDED|80.0|-10.37|0.19|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: MIJ821 0.16 mg/kg weekly minus placebo."||0.19|-10.37|0.1082
70879839|NCT03760146|141245111|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.81|||||TWO_SIDED|95.0|0.71|0.93||||||Serotype 4: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.93|0.71|
70959396|NCT03756129|141422830|SUPERIORITY||Mean Difference (Net)|-5.42||||0.0993|TWO_SIDED|80.0|-10.83|-0.02|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: MIJ821 0.32 mg/kg weekly minus placebo."||-0.02|-10.83|0.0993
70959397|NCT03756129|141422830|SUPERIORITY||Mean Difference (Net)|-6.46||||0.0598|TWO_SIDED|80.0|-11.78|-1.15|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: MIJ821 0.16 mg/kg biweekly minus placebo."||-1.15|-11.78|0.0598
70959398|NCT03756129|141422830|SUPERIORITY||Mean Difference (Net)|-3.06||||0.2491|TWO_SIDED|80.0|-8.86|2.74|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: MIJ821 0.32 mg/kg biweekly minus placebo."||2.74|-8.86|0.2491
70959399|NCT03035201|141422847|OTHER|two-tailed test of the null hypothesis of no differences between groups.|Mean from linear contrast|0.03|STANDARD_ERROR_OF_MEAN|0.02|<|0.05|TWO_SIDED|95.0|-0.02|0.08||Not adjusted|Mixed Models Analysis||Marginal effect of cocoa flavonal versus cocoa placebo based on the mean difference between linear contrasts.|Marginal comparisons from a repeated measures model using a linear contrast to estimate the mean differences between baseline versus average values across follow-up.|Wald test of a linear contrast from the mixed effects analysis....see protocol.|0.08|-0.02|<0.05
70959400|NCT03035201|141422848|EQUIVALENCE|two-tailed test of the null hypothesis of no differences between groups.|Mean difference of linear contrasts|0.07|STANDARD_ERROR_OF_MEAN|0.02|<|0.05|TWO_SIDED|95.0|0.02|0.12||Not adjusted|Wald test||Marginal effects of multivitamin versus multivitamin placebo|Marginal comparisons from a repeated measures model using a linear contrast to estimate the mean differences between baseline versus average values across follow-up.|Wald test of a linear contrast from the mixed effects analysis....see protocol|0.12|0.02|<0.05
70959401|NCT03035201|141422849|EQUIVALENCE|Proportional hazards regression -- unadjusted two-sided test|Hazard Ratio (HR)|0.76||||0.15|TWO_SIDED|95.0|0.52|1.11||Not adjusted|Regression, Cox||Comparison group is placebo|||1.11|0.52|0.15
70959402|NCT03035201|141422850|EQUIVALENCE|Unadjusted 2-sided test|Cox Proportional Hazard|0.91||||0.62|TWO_SIDED|95.0|0.63|1.32||Unadjusted|Regression, Cox||Comparison group is placebo.|||1.32|0.63|0.62
70959403|NCT03035201|141422851|EQUIVALENCE|Cocoa Flavonal minus Placebo|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.24|TWO_SIDED|95.0|-0.02|0.08||Unadjusted|Mixed Models Analysis|Wald test comparing linear contrasts|Cocoa Flavonal minus placebo|||0.08|-0.02|0.24
70959404|NCT03035201|141422852|EQUIVALENCE|two-sided|Median Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.41|TWO_SIDED|95.0|-0.04|0.09||Unadjusted|Mixed Models Analysis|Comparison of linear contrasts: cocoa flavonal minus placebo|Cocoa flavonal minus placebo|Unadjusted 2-tailed test||0.09|-0.04|0.41
70959405|NCT03035201|141422853|EQUIVALENCE|2 sided test, multivitamin minus placebo|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.02|TWO_SIDED|95.0|0.01|0.11||Unadjusted|Mixed Models Analysis|Comparison of linear contrasts|Multivitamin minus placebo|2-sided test, unadjusted||0.11|0.01|0.02
70879840|NCT03760146|141245111|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.83|||||TWO_SIDED|95.0|0.74|0.94||||||Serotype 5: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.94|0.74|
70879841|NCT03760146|141245111|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.76|||||TWO_SIDED|95.0|0.66|0.88||||||Serotype 6A: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.88|0.66|
70959406|NCT03035201|141422854|EQUIVALENCE|2-sided, unadjusted|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.04|TWO_SIDED|95.0|0.002|0.126||Unadjusted|Mixed Models Analysis|Comparison of linear contrasts|Multivitamin minus placebo|Multivitamin minus placebo||0.126|0.002|0.04
70959407|NCT01880528|141422871|SUPERIORITY|||||||0.006|||||||Kruskal-Wallis|||||||0.006
70959408|NCT01880528|141422872|SUPERIORITY|||||||0.0337|||||||Kruskal-Wallis|||||||0.0337
70959409|NCT01880528|141422873|SUPERIORITY|||||||0.0427|||||||Kruskal-Wallis|||||||0.0427
70959410|NCT01880528|141422874|SUPERIORITY|||||||0.0237|||||||Kruskal-Wallis|||||||0.0237
70959411|NCT01439360|141422875|SUPERIORITY_OR_OTHER||Vaccine efficacy (VE)|63.2|||||TWO_SIDED|97.5|51.8|72.3|||Regression, Cox|Adjusted for age category and stratified for cohort.|VE was defined as the hazard ratio of cases of influenza A and or B disease in subjects receiving D-QIV vaccine in contrast with subjects receiving non-influenza vaccine control subtracted from 1.|The efficacy of the D-QIV vaccine would be demonstrated if the LL of the two-sided 97.5% CI for vaccine efficacy (VE) is above (\>) 25%.||72.3|51.8|
70959412|NCT01439360|141422876|SUPERIORITY_OR_OTHER||Vaccine efficacy (VE)|49.8|||||TWO_SIDED|97.5|41.8|56.8|||Regression, Cox|Adjusted for age category and stratified for cohort|VE was defined as the hazard ratio of cases of influenza A and or B disease in subjects receiving D-QIV vaccine in contrast with subjects receiving non-influenza vaccine control subtracted from 1.|The efficacy of the D-QIV vaccine would be demonstrated if the LL of the two-sided 97.5% CI for VE is above 15%.||56.8|41.8|
70959413|NCT01912456|141422919|OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||< 0.001
70959414|NCT01912456|141422919|OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||< 0.001
70879842|NCT03760146|141245111|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.83|||||TWO_SIDED|95.0|0.73|0.95||||||Serotype 6B: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.95|0.73|
70959415|NCT01912456|141422919|OTHER||||||=|0.114|||||||Mixed Models Analysis|||||||= 0.114
70959416|NCT01912456|141422920|OTHER||difference in percentages of responder|13.8|||||TWO_SIDED|95.0|-2.8|29.7||||||||29.7|-2.8|
70959417|NCT01912456|141422921|OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||< 0.001
70959418|NCT01912456|141422921|OTHER||||||=|0.018|||||||Mixed Models Analysis|||||||= 0.018
70959419|NCT01912456|141422921|OTHER||||||=|0.31|||||||Mixed Models Analysis|||||||= 0.31
70959420|NCT00596427|141422970|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||mixed-effects regression models|||Change from baseline between groups were compared.||||<0.01
70959421|NCT00596427|141422971|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||mixed-effects regression models|||Change from baseline between groups was compared.||||<0.001
70959422|NCT00596427|141422972|SUPERIORITY_OR_OTHER||||||<|0.1||95.0|||||mixed-effects regression models|This model had fixed effects of treatment, visit and treatment by visit interaction and a random subject effect.||Comparison of change from baseline between groups (treatment effect)||||<0.1
70959423|NCT00596427|141422973|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||mixed-effects regression models|||||||<0.01
70959424|NCT00596427|141422974|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||mixed-effects regression models|||||||<0.05
70959425|NCT00596427|141422975|SUPERIORITY_OR_OTHER||||||<|0.1||95.0|||||mixed-effects regression models|||Change from baseline between groups were compared (treatment effect)||||<0.1
70959426|NCT00596427|141422976|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||mixed-effects regression models|||||||0.05
70959427|NCT00596427|141422977|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||mixed-effects regression models|||||||0.6
70959428|NCT00596427|141422978|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||mixed-effects regression models|||Treatment effect of change from baseline||||0.3
70959429|NCT00596427|141422979|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||mixed-effects regression models|||Treatment effect of change from baseline||||<0.0001
70959430|NCT00596427|141422980|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||mixed-effects regression models|||Treatment effect of change from baseline||||<0.01
70959431|NCT00596427|141422981|SUPERIORITY_OR_OTHER||||||<|0.1||95.0|||||mixed-effects regression models|||||||<0.1
70959432|NCT00320541|141422982|SUPERIORITY_OR_OTHER|||||||0.117||95.0||||Statistical significance at 0.05 level was required.|Fisher Exact|||Assuming the response rate for the PB arm is 34% and the addition of gemcitabine will improve it to 54%, then a sample size of 170 evaluable participants (85 per arm) will give an 80% statistical power to detect the difference, using a 1-sided test at the significance level of 0.05. Confidence levels are exact binomial 95% Confidence Intervals.||||0.117
70959433|NCT00320541|141422983|SUPERIORITY_OR_OTHER|||||||0.247||95.0|||||Log Rank|||||||0.247
70959434|NCT00320541|141422984|SUPERIORITY_OR_OTHER|||||||0.475||95.0|||||Log Rank|||||||0.475
70959435|NCT00320541|141422985|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.010
70959436|NCT00320541|141422986|SUPERIORITY_OR_OTHER|||||||0.119||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.119
70959437|NCT00320541|141422987|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.023
70959438|NCT00320541|141422988|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.002
70959439|NCT00320541|141422989|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.004
70879843|NCT03760146|141245111|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.86|||||TWO_SIDED|95.0|0.77|0.96||||||Serotype 7F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.96|0.77|
70879844|NCT03760146|141245111|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.93|||||TWO_SIDED|95.0|0.82|1.05||||||Serotype 9V: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||1.05|0.82|
70879845|NCT03760146|141245111|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.89|1.13||||||Serotype 14: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||1.13|0.89|
70959440|NCT00320541|141422990|SUPERIORITY_OR_OTHER|||||||0.067||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.067
70879846|NCT03760146|141245111|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.85|||||TWO_SIDED|95.0|0.74|0.97||||||Serotype 18C: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.97|0.74|
70959441|NCT00320541|141422991|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.036
70959442|NCT01605292|141422992|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
70959443|NCT01605292|141422993|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||t-test, 2 sided|||||||0.006
70879847|NCT03760146|141245111|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.8|||||TWO_SIDED|95.0|0.71|0.9||||||Serotype 19A: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.90|0.71|
70879848|NCT03760146|141245111|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.8|||||TWO_SIDED|95.0|0.7|0.91||||||Serotype 19F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.91|0.70|
70959444|NCT01605292|141422994|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
70959445|NCT01605292|141422995|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||Fisher Exact|||||||0.56
70959446|NCT01605292|141422996|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
70959447|NCT01605292|141422997|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Chi-squared|||||||0.07
70959448|NCT01605292|141422998|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Fisher Exact|||||||0.75
70959449|NCT01605292|141423000|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Fisher Exact|||||||0.007
70959450|NCT03057977|141423002|SUPERIORITY|H0: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.75|||<|0.0001|TWO_SIDED|95.04|0.65|0.86|||Regression, Cox||Comparison vs. Placebo \[T/P\]|"Model with terms for age, baseline eGFR (CKD-EPK)cr, region, baseline diabetes status, sex, baseline LVEF, and treatment.~alpha = 0.0496 (resulting from interim analysis) eGFR (CKP-EPI)cr: Glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement LVEF: Left ventricular ejection fraction."||0.86|0.65|<0.0001
70879849|NCT03760146|141245111|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.83|||||TWO_SIDED|95.0|0.7|0.97||||||Serotype 23F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.97|0.70|
70879850|NCT03760146|141245112|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.55|||||TWO_SIDED|95.0|0.49|0.62||||||Serotype 8: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.62|0.49|
70959451|NCT03057977|141423003|SUPERIORITY|H0: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.7||||0.0003|TWO_SIDED|95.04|0.58|0.85|||Joint frailty model||HR vs placebo of recurrent HFF|"Model accounts for dependence between recurrent HHF and cardiovascular death, with terms for age, baseline eGFR (CKD-EPK)cr, region, baseline diabetes status, sex, baseline LVEF, and treatment.~eGFR (CKP-EPI)cr: Glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement LVEF: Left ventricular ejection fraction."||0.85|0.58|0.0003
70879851|NCT03760146|141245112|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.86|||||TWO_SIDED|95.0|1.63|2.12||||||Serotype 10A: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||2.12|1.63|
70879852|NCT03760146|141245112|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.75|||||TWO_SIDED|95.0|1.52|2.01||||||Serotype 11A: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||2.01|1.52|
70959452|NCT03057977|141423004|SUPERIORITY|H0: There is no difference between the effect of placebo and the effect of empagliflozin.|Treatment by time interaction|1.733|||<|0.0001|TWO_SIDED|99.9|0.669|2.796|||Random intercept random coef. model||Empa vs Placebo slope \[/year\]|"Random coefficient model allowing for random intercept and random slope per patient, with the same factors used for the primary endpoint (age, baseline eGFR (CKD-EPK)cr, region, baseline diabetes status, sex, baseline LVEF, and treatment) and additional factors time, treatment-by-time interaction, and baseline eGFR (CKD-EPI)cr-by-time interaction. Only on-treatment data from treated patients were used.~alpha=0.001"||2.796|0.669|<0.0001
70959453|NCT03057977|141423005|OTHER||Hazard Ratio (HR)|0.5||||0.0019|TWO_SIDED|95.0|0.32|0.77|||Regression, Cox|Cox regression model with terms for age, baseline eGFR (CKD-EPK)cr, region, baseline diabetes status, sex, baseline LVEF, and treatment.|Comparison vs. Placebo|||0.77|0.32|0.0019
70959454|NCT03057977|141423006|OTHER||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.59|0.81|||Regression, Cox|Cox regression model with terms for age, baseline eGFR (CKD-EPK)cr, region, baseline diabetes status, sex, baseline LVEF, and treatment.|Comparison vs Placebo|||0.81|0.59|<0.0001
70959455|NCT03057977|141423007|OTHER||Hazard Ratio (HR)|0.92||||0.4133|TWO_SIDED|95.0|0.75|1.12|||Regression, Cox|Model with terms for age, baseline eGFR (CKD-EPI), region, baseline diabetes status, sex, baseline LVEF and treatment.|Comparison vs. Placebo|||1.12|0.75|0.4133
70959456|NCT03057977|141423008|OTHER||Hazard Ratio (HR)|0.92||||0.3536|TWO_SIDED|95.0|0.77|1.1|||Regression, Cox|Cox regression model with terms for age, baseline eGFR (CKD-EPI), region, baseline diabetes status, sex, baseline LVEF and treatment.|Comparison vs. placebo|||1.10|0.77|0.3536
70959457|NCT03057977|141423009|OTHER||Hazard Ratio (HR)|0.86||||0.3576|TWO_SIDED|95.0|0.62|1.19|||Regression, Cox|Cox regression model with terms for age, baseline eGFR (CDK-EPI), region, sex, baseline LVEF and treatment.|Comparison vs. placebo|||1.19|0.62|0.3576
70959458|NCT03057977|141423010|OTHER||Difference of adjusted means|2.06|STANDARD_ERROR_OF_MEAN|0.97||0.034|TWO_SIDED|95.0|0.16|3.96|||Mixed Model|Mixed model for repeated measures (MMRM)|Comparison vs. placebo|Mixed model with age, baseline eGFR (CKD-EPI) as linear covariate(s) and region, baseline diabetes status, sex, baseline LVEF, week reachable, treatment by visit interaction, baseline KCCQ - Clinical Summary Score by Visit interaction as fixed effects. An unstructured covariance structure has been used.||3.96|0.16|0.0340
70959459|NCT03057977|141423011|OTHER||Hazard Ratio (HR)|0.85||||0.0065|TWO_SIDED|95.0|0.75|0.95|||Joint frailty model||Comparison vs. placebo|Joint frailty model with terms for age, baseline eGFR (CDK-EPI), region, sex, baseline diabetes status and baseline LVEF. Model accounts for dependence between recurrent all-cause hospitalizations and all-cause mortality.||0.95|0.75|0.0065
70959460|NCT02401867|141423012|NON_INFERIORITY_OR_EQUIVALENCE|We selected our initial sample size of 150 participants to detect a clinically meaningful % discordance between the two sampling approaches and achieve 90% power at the 0.05 alpha-level using McNemar's test adjusted for analysis of clustered matched-pair data.||||||0.29||||||Statistical significance was determined at an a priori threshold of p \<0.05|McNemar|Degrees of freedom = 1||Comparing the concordance of the HPV DNA-positive results to the cervical provider swab HPV DNA test results (reference) using the McNemar's test, a two-sample test for binomial proportions for matched-pair data. Null hypothesis: The sensitivities between swab 1 (self-vaginal) and swab 2 (provider-cervical) are equal \[ H0 : p1 = p2 \]||||.29
70959461|NCT02401867|141423012|SUPERIORITY_OR_OTHER||Kappa|0.75|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|0.58|0.92||A priori threshold: p\<0.05|Kappa||Using the asymptotic standard error assuming the null hypothesis.|Concordance of HPV DNA detection between self-swab and provider swab assessed via an unweighted Kappa (K) statistic to determine the percentage agreement beyond that expected by chance.||0.92|0.58|<0.001
70959462|NCT02401867|141423012|SUPERIORITY_OR_OTHER||Sensitivity|71.43|||||TWO_SIDED|95.0|47.82|88.72|||||Used exact confidence intervals.|Assessed sensitivity of vaginal self-swab HPV DNA with respect to provider cervical HPV DNA (reference test).||88.72|47.82|
70959463|NCT02401867|141423012|NON_INFERIORITY_OR_EQUIVALENCE|Assessed specificity of vaginal self-swab HPV DNA with respect to provider cervical HPV DNA (reference test).|Specificity|98.18|||||TWO_SIDED|95.0|93.59|99.78|||||Used exact confidence intervals.|||99.78|93.59|
70959464|NCT02401867|141423012|SUPERIORITY_OR_OTHER||Positive Predictive Value|88.24|||||TWO_SIDED|95.0|63.56|98.54|||||Used exact confidence intervals.|Assessed positive predictive value of vaginal self-swab HPV DNA with respect to provider cervical HPV DNA (reference test).||98.54|63.56|
70959465|NCT02401867|141423012|SUPERIORITY_OR_OTHER||Negative predictive value|94.74|||||TWO_SIDED|95.0|88.9|98.04|||||Used exact confidence intervals|Assessed negative predictive value of vaginal self-swab HPV DNA with respect to provider cervical HPV DNA (reference test).||98.04|88.90|
70959466|NCT00362453|141423013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-118.8||||0.0005|TWO_SIDED|95.0|-183.66|-53.94|||Mixed Models Analysis|||||-53.94|-183.66|0.0005
70959467|NCT00362453|141423014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-324.6||||0.001|TWO_SIDED|95.0|-513.98|-135.22|||Mixed Models Analysis|||12 Week||-135.22|-513.98|0.001
70959468|NCT00362453|141423014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-183.2||||0.06|TWO_SIDED|95.0|-372.58|6.18|||Mixed Models Analysis|||24 Week||6.18|-372.58|0.06
70959469|NCT00362453|141423014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-105.3||||0.3|TWO_SIDED|95.0|-294.68|84.08|||Mixed Models Analysis|||48 week||84.08|-294.68|0.3
70959470|NCT00362453|141423015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.9||||0.1|TWO_SIDED|95.0|-53.04|7.24|||Mixed Models Analysis|||12 week||7.24|-53.04|0.1
70959471|NCT00362453|141423015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.8||||0.3|TWO_SIDED|95.0|-44.94|15.34|||Mixed Models Analysis|||24 week||15.34|-44.94|0.3
70959472|NCT00362453|141423015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.65||||0.8|TWO_SIDED|95.0|-33.79|26.49|||Mixed Models Analysis|||48 Week||26.49|-33.79|0.8
70959473|NCT00362453|141423016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-66.95||||0.05|TWO_SIDED|95.0|-131.81|-2.09|||Mixed Models Analysis|||24 Week||-2.09|-131.81|0.05
70959474|NCT00362453|141423016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.15||||0.2|TWO_SIDED|95.0|-111.01|18.71|||Mixed Models Analysis|||48 Week||18.71|-111.01|0.2
70959475|NCT00362453|141423017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15||||0.01|TWO_SIDED|95.0|-3.82|-0.49|||Mixed Models Analysis|||12 Week||-0.49|-3.82|0.01
70959476|NCT00362453|141423017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.4|TWO_SIDED|95.0|-2.31|1.02|||Mixed Models Analysis|||24 Week||1.02|-2.31|0.4
70959477|NCT00362453|141423017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||1|TWO_SIDED|95.0|-1.62|1.7|||Mixed Models Analysis|||48 weeks||1.70|-1.62|1.0
70959478|NCT00362453|141423018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71||||0.002|TWO_SIDED|95.0|-2.75|-0.66|||Mixed Models Analysis|||12 Week||-0.66|-2.75|0.002
70959479|NCT00362453|141423018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.3|TWO_SIDED|95.0|-1.58|0.51|||Mixed Models Analysis|||24 Week||0.51|-1.58|0.3
70959480|NCT00362453|141423018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.06|TWO_SIDED|95.0|-2.09|0.02|||Mixed Models Analysis|||48 Week||0.02|-2.09|0.06
70959481|NCT00362453|141423019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.88||||5e-05|TWO_SIDED|95.0|-15.91|-5.84|||Mixed Models Analysis|||12 Week||-5.84|-15.91|0.00005
70959482|NCT00362453|141423019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.12||||0.05|TWO_SIDED|95.0|-10.15|-0.08|||Mixed Models Analysis|||24 Week||-0.08|-10.15|0.05
70959483|NCT00362453|141423019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.98||||0.02|TWO_SIDED|95.0|-11.06|-0.91|||Mixed Models Analysis|||48 Week||-0.91|-11.06|0.02
70959484|NCT00362453|141423020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.08||||0.1|TWO_SIDED|95.0|-10.34|110.5|||Mixed Models Analysis|||12 Week||110.50|-10.34|0.1
70959485|NCT00362453|141423020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.71||||0.1|TWO_SIDED|95.0|-15.07|102.5|||Mixed Models Analysis|||24 Week||102.50|-15.07|0.1
70959486|NCT00362453|141423020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.61||||0.7|TWO_SIDED|95.0|-49.36|78.59|||Mixed Models Analysis|||48 Weeks||78.59|-49.36|0.7
70959487|NCT00362453|141423021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.7|TWO_SIDED|95.0|-0.54|0.34|||Mixed Models Analysis|||12 Weeks||0.34|-0.54|0.7
70959488|NCT00362453|141423021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.7|TWO_SIDED|95.0|-0.37|0.52|||Mixed Models Analysis|||24 Weeks||0.52|-0.37|0.7
70959489|NCT00362453|141423021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.6|TWO_SIDED|95.0|-0.55|0.34|||Mixed Models Analysis|||48 weeks||0.34|-0.55|0.6
70959490|NCT00362453|141423022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7||||0.009|TWO_SIDED|95.0|-11.63|-1.77|||Mixed Models Analysis|||12 Week||-1.77|-11.63|0.009
70959491|NCT00362453|141423022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3||||0.04|TWO_SIDED|95.0|-10.23|-0.37|||Mixed Models Analysis|||24 Weeks||-0.37|-10.23|0.04
70959492|NCT00362453|141423022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.9||||0.0006|TWO_SIDED|95.0|-13.83|-3.97|||Mixed Models Analysis|||48 Week||-3.97|-13.83|0.0006
70959493|NCT00362453|141423023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71||||0.04|TWO_SIDED|95.0|0.03|1.39|||Mixed Models Analysis|||12 Weeks||1.39|0.03|0.04
70959494|NCT00362453|141423023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.02|TWO_SIDED|95.0|0.17|1.53|||Mixed Models Analysis|||24 Weeks||1.53|0.17|0.02
70959495|NCT00362453|141423023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96||||0.007|TWO_SIDED|95.0|0.28|1.64|||Mixed Models Analysis|||48 Weeks||1.64|0.28|0.007
70959496|NCT00362453|141423024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.43||||0.004|TWO_SIDED|95.0|2.5|12.36|||Mixed Models Analysis|||12 Weeks||12.36|2.50|0.004
70959497|NCT00362453|141423024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.51||||0.08|TWO_SIDED|95.0|-0.42|9.45|||Mixed Models Analysis|||24 Weeks||9.45|-0.42|0.08
70959498|NCT00362453|141423024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.32||||0.01|TWO_SIDED|95.0|1.38|11.25|||Mixed Models Analysis|||48 Weeks||11.25|1.38|0.01
70959499|NCT00362453|141423025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.9|TWO_SIDED|95.0|-6.15|6.57|||Mixed Models Analysis|||12 Weeks||6.57|-6.15|0.9
70959500|NCT00362453|141423025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||1|TWO_SIDED|95.0|-6.47|6.25|||Mixed Models Analysis|||24 Weeks||6.25|-6.47|1.0
70959501|NCT00362453|141423025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.77||||0.1|TWO_SIDED|95.0|-1.59|11.13|||Mixed Models Analysis|||48 Weeks||11.13|-1.59|0.10
70959502|NCT02047643|141423034|OTHER|||||||0.45|||||||Fisher Exact|Two-sided Fisher Exact test||||||.45
70959503|NCT02047643|141423035|OTHER|||||||0.66|||||||Fisher Exact|Two-sided Fisher Exact test||||||.66
70959504|NCT00120406|141423057|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 10%.|||||<|0.01||95.0||||P-value has been adjusted for multiplicity.|z-test, one-sided|||||||<0.01
70959505|NCT00120406|141423058|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||P-value has been adjusted for multiplicity.|Generalized estimating equation (GEE)|||||||<0.01
70959506|NCT03907410|141423126|SUPERIORITY||Mean Difference (Final Values)|15.0|||||TWO_SIDED|95.0|2.0|28.0||||||Multivariate comparison of Experiment phase adherence (Months 1-3) comparing Arm 1 (Full Intervention arm) to Arm 3 (Active control). Arm 3 is used as the reference. This randomized controlled trial was powered for Arm 1 vs. Arm 3 comparisons, hence the Arm 1 vs. Arm 3 outcome data for adherence to the inhaled corticosteroid regime. The study did not have sufficient power for Arm 2 comparisons.||28|2|
70959507|NCT03907410|141423126|SUPERIORITY||Mean Difference (Final Values)|-6.0|||||TWO_SIDED|95.0|-20.0|7.0||||||Multivariate comparison of Observation phase adherence (Months 4-6) comparing Arm 1 (Full Intervention arm) to Arm 3 (Active control). Arm 3 is used as the reference. This randomized controlled trial was powered for Arm 1 vs. Arm 3 comparisons, hence the Arm 1 vs. Arm 3 outcome data for adherence to the inhaled corticosteroid regime. The study did not have sufficient power for Arm 2 comparisons.||7|-20|
70959508|NCT04218084|141423160|OTHER|Mixed Model Repeated Measures analysis|Difference in LS mean|-7.73||||0.0043|TWO_SIDED|95.0|-13.03|-2.42|||Mixed Models for Repeated Measures|||Week 24||-2.42|-13.03|0.0043
70879853|NCT03760146|141245112|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.48|||||TWO_SIDED|95.0|1.27|1.72||||||Serotype 12F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||1.72|1.27|
70879854|NCT03760146|141245112|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|3.12|||||TWO_SIDED|95.0|2.62|3.71||||||Serotype 15B: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||3.71|2.62|
70959509|NCT00712673|141423185|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.088|<|0.0001|TWO_SIDED|95.0|-0.657|-0.312||Stepwise testing procedure applied to control type 1 error: lixisenatide (morning) compared with placebo (combined), if found statistically significant, then lixisenatide (evening) compared with placebo (combined).|ANCOVA|||To detect 0.5%(or 0.4%) difference between 1 lixisenatide arm and placebo(combined), 225 patients in lixisenatide arm, 170 in placebo(combined) would provide a power of 97% (or 87%) assuming common standard deviation=1.3% with 2-sided test at 5% significance. Statistical testing:2-sided at significance level=0.05. Analysis of co-variance(ANCOVA)included treatment arms, randomization strata of screening HbA1c(\<8.0,\>=8.0%),BMI(\<30,\>=30 kg/m\^2),country as fixed effects, baseline HbA1c as covariate.||-0.312|-0.657|<0.0001
70959510|NCT00712673|141423185|SUPERIORITY_OR_OTHER||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.088|<|0.0001|TWO_SIDED|95.0|-0.54|-0.193||Stepwise testing procedure applied to control type 1 error: lixisenatide (morning) compared with placebo (combined), if found statistically significant, then lixisenatide (evening) compared with placebo (combined).|ANCOVA|||To detect 0.5%(or 0.4%) difference between 1 lixisenatide arm and placebo(combined), 225 patients in lixisenatide arm, 170 in placebo(combined) would provide a power of 97% (or 87%) assuming common standard deviation=1.3% with 2-sided test at 5% significance. Statistical testing:2-sided at significance level=0.05. Analysis of co-variance(ANCOVA)included treatment arms, randomization strata of screening HbA1c(\<8.0,\>=8.0%),BMI(\<30,\>=30 kg/m\^2),country as fixed effects, baseline HbA1c as covariate.||-0.193|-0.540|<0.0001
70959511|NCT01498653|141423227|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|28.5|||<|0.001|TWO_SIDED|95.0|20.1|36.9|||ANCOVA|||||36.9|20.1|<0.001
70959512|NCT00298090|141423243|SUPERIORITY_OR_OTHER||Other|0.0||||0.55|TWO_SIDED|95.0|-0.8|1.48|||repeated measures model||A repeated measures model was used to assess whether the one-minute average StO2 values differed systematically between pre and post arterial line placement.|||1.48|-0.80|0.55
70959513|NCT01718353|141423250|OTHER|||||||0.02|||||||ANOVA|||%ARNL change from baseline at Cycle 1 Day 8 in participants with ≥50% decrease in PSA at Cycle 4 was compared with that of participants who did not have ≥50% decrease in PSA at Cycle 4||||0.02
70959514|NCT01718353|141423258|OTHER|||||||0.0927|||||||ANOVA|||MTB change from baseline at Cycle 1 Day 8 in participants with ≥30% decrease in PSA at Cycle 4 was compared with that of participants who did not have ≥30% decrease in PSA at Cycle 4||||0.0927
70959515|NCT01078675|141423259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.88|STANDARD_DEVIATION|18.222|<|0.001|TWO_SIDED|-42.88|-45.44|-40.32||P-value\<0.001 at Month 24. No adjustment for multiple comparisons is made for individual age group.|ANCOVA|P-value is two-sided and based on ANCOVA using age group as the fixed factor, and study centre and the baseline value as covariates.||||-40.32|-45.44|<0.001
70959516|NCT00899548|141423285|SUPERIORITY||Hazard Ratio (HR)|1.76||||0.0002|TWO_SIDED|95.0|1.23|2.52|||Gehan|Distributions compared between using the Gehan test, which gives more weight to early differences.||||2.52|1.23|.0002
70959517|NCT00899548|141423286|OTHER||Cox Proportional Hazard|1.19||||0.001|TWO_SIDED|95.0|1.07|1.32|||Regression, Cox|||Hazard ratio||1.32|1.07|0.001
70959518|NCT00899548|141423289|SUPERIORITY||Hazard Ratio (HR)|1.7||||0.001|TWO_SIDED|95.0|1.18|2.45|||Gehan|Distributions compared between using the Gehan test, which gives more weight to early differences.||||2.45|1.18|.001
70879855|NCT03760146|141245112|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.99|||||TWO_SIDED|95.0|1.7|2.32||||||Serotype 22F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||2.32|1.70|
70879856|NCT03760146|141245112|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.38|||||TWO_SIDED|95.0|1.21|1.57||||||Serotype 33F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||1.57|1.21|
70879857|NCT03760146|141245113|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.84|1.26||||||Serotype 1: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.26|0.84|
70879858|NCT03760146|141245113|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.06|||||TWO_SIDED|95.0|0.92|1.22||||||Serotype 3: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.22|0.92|
70879859|NCT03760146|141245113|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.1|||||TWO_SIDED|95.0|0.87|1.38||||||Serotype 4: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.38|0.87|
70959519|NCT00710021|141423308|SUPERIORITY_OR_OTHER|||||||0.53||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||0.53
70959520|NCT00710021|141423309|SUPERIORITY_OR_OTHER|||||||0.038||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||0.038
70959521|NCT00710021|141423310|SUPERIORITY_OR_OTHER|||||||0.047||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||0.047
70959522|NCT00710021|141423311|SUPERIORITY_OR_OTHER|||||||0.12||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||0.12
70879860|NCT03760146|141245113|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.88|||||TWO_SIDED|95.0|0.72|1.07||||||Serotype 5: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.07|0.72|
70959523|NCT00710021|141423312|SUPERIORITY_OR_OTHER|||||||0.31||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Ifit1 expression.||||||0.31
70959524|NCT00710021|141423313|SUPERIORITY_OR_OTHER|||||||0.019||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Ifit1 expression.||||||0.019
70959525|NCT00710021|141423314|SUPERIORITY_OR_OTHER|||||||0.28||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Ifi44 expression.||||||0.28
70959526|NCT00710021|141423315|SUPERIORITY_OR_OTHER|||||||0.05||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Ifi44 expression.||||||0.050
70959527|NCT00710021|141423316|SUPERIORITY_OR_OTHER|||||||0.29||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Mx1 expression.||||||0.29
70959528|NCT00710021|141423317|SUPERIORITY_OR_OTHER|||||||0.014||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Mx1 expression.||||||0.014
70959529|NCT00710021|141423318|SUPERIORITY_OR_OTHER|||||||0.96||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline serum C3 level.||||||0.96
70879861|NCT03760146|141245113|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.21|||||TWO_SIDED|95.0|0.95|1.53||||||Serotype 6A: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.53|0.95|
70959530|NCT00710021|141423319|SUPERIORITY_OR_OTHER|||||||0.67||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline serum C3 level.||||||0.67
70959531|NCT00710021|141423320|SUPERIORITY_OR_OTHER|||||||0.59||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline serum C4 level.||||||0.59
70959532|NCT00710021|141423321|SUPERIORITY_OR_OTHER|||||||0.65||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline serum C4 level.||||||0.65
70959533|NCT00710021|141423322|SUPERIORITY_OR_OTHER|||||||0.86||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||0.86
70959534|NCT00710021|141423323|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
70959535|NCT00710021|141423324|SUPERIORITY_OR_OTHER|||||||0.62||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline SELENA-SLEDAI score.||||||0.62
70879862|NCT03760146|141245113|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.25|||||TWO_SIDED|95.0|1.0|1.56||||||Serotype 6B: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.56|1.00|
70959536|NCT00710021|141423325|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
70959537|NCT00710021|141423326|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
70959538|NCT00710021|141423327|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
70959539|NCT00710021|141423328|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
70959540|NCT00710021|141423329|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
70959541|NCT00710021|141423330|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
70959542|NCT00710021|141423331|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
70959543|NCT00710021|141423332|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
70959544|NCT00710021|141423333|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
70959545|NCT00710021|141423334|SUPERIORITY_OR_OTHER|||||||0.1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Cochran-Mantel-Haenszel|Note that none of the Grade 3 or above events were considered by the investigators to be related to study treatment.||||||0.10
70959546|NCT02112838|141423335|SUPERIORITY||Mean Difference (Final Values)|19.9||||0.97|TWO_SIDED|95.0|-910.6|950.5|||ANCOVA|||||950.5|-910.6|0.97
70959547|NCT02112838|141423335|SUPERIORITY||Mean Difference (Final Values)|-399.7||||0.4|TWO_SIDED|95.0|-1320.8|521.3|||ANCOVA|||||521.3|-1320.8|0.40
70959548|NCT00557947|141423352|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence is demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of INTRADERMAL SUTURE successful subjects) does not exceed 12%.|difference proportions of successes (%)|4.8||||0.2188|TWO_SIDED|95.0|0.0|10.9|||McNemar||The level of significance for statistical testing was 0.05 for this study.|||10.9|-0.0|0.2188
70959549|NCT00557947|141423353|SUPERIORITY_OR_OTHER||||||<|0.0001||0.0|||||t-test, 2 sided|||||||<0.0001
70959550|NCT00557947|141423354|SUPERIORITY_OR_OTHER|||||||0.3877||0.0|||||McNemar|||||||0.3877
70959551|NCT00557947|141423355|SUPERIORITY_OR_OTHER|||||||0.7539||0.0|||||McNemar|||||||0.7539
70959552|NCT00557947|141423356|SUPERIORITY_OR_OTHER|||||||1||0.0|||||McNemar|||||||1.0000
70959553|NCT00822523|141423370|SUPERIORITY_OR_OTHER|||||||0.61|||||||t-test, 2 sided|||Two sample t-test comparing baseline and day 1 H0: There is no change in mean force between baseline and day 1 HA: There is change in mean force between baseline and day 1||||0.61
70959554|NCT00822523|141423370|SUPERIORITY_OR_OTHER|||||||0.787|||||||t-test, 2 sided|||Two sample t-test comparing baseline and day 2 H0: There is no change in mean force between baseline and day 2 HA: There is change in mean force between baseline and day 2||||0.787
70959555|NCT00822523|141423370|SUPERIORITY_OR_OTHER|||||||0.234|||||||t-test, 2 sided|||Two sample t-test comparing baseline and day 4 H0: There is no change in mean force between baseline and day 4 HA: There is change in mean force between baseline and day 4||||0.234
70959556|NCT00822523|141423370|SUPERIORITY_OR_OTHER|||||||0.256|||||||t-test, 2 sided|||Two sample t-test comparing baseline and day 14 H0: There is no change in mean force between baseline and day 14 HA: There is change in mean force between baseline and day 14||||0.256
70959557|NCT00822523|141423370|SUPERIORITY_OR_OTHER|||||||0.292|||||||t-test, 2 sided|||Two sample t-test comparing baseline and day 21 H0: There is no change in mean force between baseline and day 21 HA: There is change in mean force between baseline and day 21||||0.292
70959558|NCT00822523|141423370|SUPERIORITY_OR_OTHER|||||||0.589|||||||t-test, 2 sided|||Two sample t-test comparing baseline and month 4 H0: There is no change in mean force between baseline and month 4 HA: There is change in mean force between baseline and month 4||||0.589
70959559|NCT00822523|141423371|SUPERIORITY_OR_OTHER|||||||0.636|||||||Repeated measure ANOVA|||Repeated measure ANOVA assessing change in the three baseline force measurements H0: There no significant difference in the three baseline force measurements HA: There is a significant difference in the three baseline force measurements||||0.636
70959560|NCT00822523|141423371|SUPERIORITY_OR_OTHER|||||||0.178|||||||Repeated measure ANOVA|||Repeated measure ANOVA assessing change in baseline force by treatment arm. H0: There is no difference in mean baseline force by treatment arm HA: There is a difference in mean baseline force by treatment arm||||0.178
70959561|NCT00822523|141423372|SUPERIORITY_OR_OTHER|||||||0.995|||||||Repeated measure ANOVA|||Repeated measure ANOVA assessing percent change (from baseline) in force for contrast of day 14 and day 21 H0: There is no difference in percent change in force between day 14 and day 21 HA: There is a difference in percent change in force between day 14 and day 21||||0.995
70959562|NCT00822523|141423372|SUPERIORITY_OR_OTHER|||||||0.2088|||||||Repeated measure ANOVA|||"Repeated measure ANOVA assessing percent change in force from baseline for day 14 and 21 by treatment arm.~H0: There is no significant different in percent change in force by treatment arm HA: There is a significant different in percent change in force by treatment arm"||||0.2088
70959563|NCT00822523|141423374|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||0.0374
70959564|NCT00822523|141423374|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.188
70959565|NCT00822523|141423374|SUPERIORITY_OR_OTHER||r value|0.8||||0.104|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.104
70959566|NCT00822523|141423376|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||0.0374
70959567|NCT00822523|141423376|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.188
70959568|NCT00822523|141423376|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.0374
70959569|NCT00822523|141423377|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||0.0374
70959570|NCT00822523|141423377|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.188
70959571|NCT00822523|141423377|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.188
70959572|NCT00822523|141423378|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||0.0374
70959573|NCT00822523|141423378|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.188
70959574|NCT00822523|141423378|SUPERIORITY_OR_OTHER||r value|0.5||||0.391|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.391
70959575|NCT00822523|141423379|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||0.0374
70959576|NCT00822523|141423379|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.188
70959577|NCT00822523|141423379|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.0374
70959578|NCT00822523|141423380|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||0.0374
70959579|NCT00822523|141423380|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.188
70959580|NCT00822523|141423380|SUPERIORITY_OR_OTHER||r value|0.4||||0.505|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.505
70959581|NCT00822523|141423381|SUPERIORITY_OR_OTHER||r value|0.99|||<|0.0001|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||<0.0001
70959582|NCT00822523|141423381|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.0374
70959583|NCT00822523|141423381|SUPERIORITY_OR_OTHER||r value|0.8||||0.104|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.104
70959584|NCT00822523|141423382|SUPERIORITY_OR_OTHER||r value|0.99|||<|0.0001|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||<0.0001
70959585|NCT00822523|141423382|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.0374
70959586|NCT00822523|141423382|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.0374
70959587|NCT00822523|141423383|SUPERIORITY_OR_OTHER||r value|0.99|||<|0.0001|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||<0.0001
70959588|NCT00822523|141423383|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.0374
70959589|NCT00822523|141423383|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.188
70959590|NCT00822523|141423384|SUPERIORITY_OR_OTHER||r value|0.99|||<|0.0001|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||<0.0001
70959591|NCT00822523|141423384|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.0374
70959592|NCT00822523|141423384|SUPERIORITY_OR_OTHER||r value|0.5||||0.391|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.391
70959593|NCT00822523|141423385|SUPERIORITY_OR_OTHER||r value|0.99|||<|0.0001|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||<0.0001
70959594|NCT00822523|141423385|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.0374
70959595|NCT00822523|141423385|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.0374
70959596|NCT00822523|141423386|SUPERIORITY_OR_OTHER||r value|0.99|||<|0.0001|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||<0.0001
70959597|NCT00822523|141423386|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.0374
70959598|NCT00822523|141423386|SUPERIORITY_OR_OTHER||r value|0.4||||0.505|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.505
70959599|NCT01315353|141423387|SUPERIORITY|Confidence interval estimation was stratified by ART use at screening using Greenwood's variance with the inverse of this variance used for the stratum weights.|Cumulative rate difference|1.7|||||ONE_SIDED|95.0|-7.9||||||The lower bound of the (lower) one-sided 95% confidence interval was provided.|Treatment comparison was made using the difference (arm B - arm A) in the stratified Kaplan-Meier estimate for the week 130 cumulative rate of CIN2+ with 95% one-sided confidence interval.|||-7.9|
70959600|NCT01315353|141423388|OTHER|||||||0.94||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05.|Log Rank|Log-rank test was stratified by ART use at screening.||Null Hypothesis: There is no difference between Arm A and Arm B with respect to time to CIN2+.||||0.94
70959601|NCT01315353|141423389|OTHER||Cumulative rate difference|4.4|||||TWO_SIDED|95.0|-4.8|13.6|||||Confidence interval estimation was stratified by ART use at screening using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (arm B - arm A) in the stratified Kaplan-Meier estimate for the week 130 cumulative rate of CIN3+ with 95% two-sided confidence interval.||13.6|-4.8|
70959602|NCT01315353|141423390|OTHER|||||||0.445||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05.|Fisher Exact|||Null hypothesis: There is no difference between Arm A and Arm B with respect to rate of premature study discontinuation.||||0.445
70959603|NCT01315353|141423391|OTHER|||||||1||||||P-value for the week 26 comparison. The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05.|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with abnormal cervical cytology results at week 26.||||1.000
70879863|NCT03760146|141245113|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.89|||||TWO_SIDED|95.0|0.74|1.07||||||Serotype 7F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.07|0.74|
70879864|NCT03760146|141245113|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.02|||||TWO_SIDED|95.0|0.83|1.26||||||Serotype 9V: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.26|0.83|
70879865|NCT03760146|141245113|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.25|||||TWO_SIDED|95.0|1.01|1.54||||||Serotype 14: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.54|1.01|
70959604|NCT01315353|141423391|OTHER|||||||0.279||||||"P-value for the week 52 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between the Arm A and Arm B with respect to the proportion of participants with abnormal cervical cytology results at week 52.||||0.279
70879866|NCT03760146|141245113|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.33|||||TWO_SIDED|95.0|1.06|1.68||||||Serotype 18C: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.68|1.06|
70879867|NCT03760146|141245113|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.85|1.25||||||Serotype 19A: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.25|0.85|
70879868|NCT03760146|141245113|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.99|||||TWO_SIDED|95.0|0.8|1.22||||||Serotype 19F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.22|0.80|
70879869|NCT03760146|141245113|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.68|||||TWO_SIDED|95.0|1.27|2.22||||||Serotype 23F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.22|1.27|
70879870|NCT03760146|141245113|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.97|||||TWO_SIDED|95.0|0.78|1.2||||||Serotype 8: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.20|0.78|
70879871|NCT03760146|141245113|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.84|1.28||||||Serotype 10A: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.28|0.84|
70879872|NCT03760146|141245113|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.22|||||TWO_SIDED|95.0|0.96|1.56||||||Serotype 11A: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.56|0.96|
70879873|NCT03760146|141245113|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.11|||||TWO_SIDED|95.0|0.88|1.39||||||Serotype 12F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.39|0.88|
70879874|NCT03760146|141245113|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.17|||||TWO_SIDED|95.0|0.88|1.56||||||Serotype 15B: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.56|0.88|
70879875|NCT03760146|141245113|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.9|||||TWO_SIDED|95.0|0.69|1.17||||||Serotype 22F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.17|0.69|
70879876|NCT03760146|141245113|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.02|||||TWO_SIDED|95.0|0.81|1.3||||||Serotype 33F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.30|0.81|
70879877|NCT03760146|141245114|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.23|||||TWO_SIDED|95.0|1.01|1.5||||||Serotype 1: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.50|1.01|
70879878|NCT03760146|141245114|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.87|1.16||||||Serotype 3: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.16|0.87|
70879879|NCT03760146|141245114|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|3.31|||||TWO_SIDED|95.0|2.65|4.13||||||Serotype 4: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||4.13|2.65|
70879880|NCT03760146|141245114|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.11|||||TWO_SIDED|95.0|0.91|1.36||||||Serotype 5: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.36|0.91|
70879881|NCT03760146|141245114|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|3.84|||||TWO_SIDED|95.0|3.06|4.83||||||Serotype 6A: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||4.83|3.06|
70879882|NCT03760146|141245114|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|3.41|||||TWO_SIDED|95.0|2.73|4.26||||||Serotype 6B: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||4.26|2.73|
70879883|NCT03760146|141245114|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.58|||||TWO_SIDED|95.0|1.3|1.91||||||Serotype 7F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.91|1.30|
70879884|NCT03760146|141245114|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|3.5|||||TWO_SIDED|95.0|2.83|4.33||||||Serotype 9V: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||4.33|2.83|
70879885|NCT03760146|141245114|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|2.39|||||TWO_SIDED|95.0|1.93|2.96||||||Serotype 14: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.96|1.93|
70879886|NCT03760146|141245114|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|3.2|||||TWO_SIDED|95.0|2.53|4.04||||||Serotype 18C: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||4.04|2.53|
70879887|NCT03760146|141245114|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|2.31|||||TWO_SIDED|95.0|1.91|2.81||||||Serotype 19A: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.81|1.91|
70879888|NCT03760146|141245114|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|2.17|||||TWO_SIDED|95.0|1.76|2.68||||||Serotype 19F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.68|1.76|
70879889|NCT03760146|141245114|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|4.8|||||TWO_SIDED|95.0|3.65|6.32||||||Serotype 23F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||6.32|3.65|
70959605|NCT01315353|141423391|OTHER|||||||0.781||||||"P-value for the week 78 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with abnormal cervical cytology results at week 78.||||0.781
70959606|NCT01315353|141423391|OTHER|||||||0.375||||||"P-value for the week 104 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with abnormal cervical cytology results at week 104.||||0.375
70959607|NCT01315353|141423391|OTHER|||||||0.444||||||"P-value for the week 130 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with abnormal cervical cytology results at week 130.||||0.444
70959608|NCT01315353|141423392|OTHER|||||||0.132||||||"P-value for the week 26 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with hr-HPV at week 26.||||0.132
70959609|NCT01315353|141423393|OTHER|||||||0.227||||||"P-value for the week 26 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with hr-HPV at week 26.||||0.227
70959610|NCT01315353|141423394|OTHER|||||||1||||||"P-value for the week 26 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with hr-HPV at week 26.||||1.000
70959611|NCT03567434|141423397|SUPERIORITY|The original hypothesis was that resting MSNA burst frequency would be higher the morning after evening binge alcohol when compared to fluid control condition. A p-value of \< 0.05 was used for significance.||||||0.283||||||The original hypothesis was that resting MSNA burst frequency would be higher the morning after evening binge alcohol when compared to fluid control condition. A p-value of \< 0.05 was used for significance.|t-test, 2 sided|||Statistical analysis on Burst Frequency (Burst/Min)||||0.283
70959612|NCT03567434|141423397|SUPERIORITY|The original hypothesis was that resting MSNA burst incidence would be higher the morning after evening binge alcohol when compared to fluid control condition. A p-value of \< 0.05 was used for significance.||||||0.92||||||The original hypothesis was that resting MSNA burst frequency would be higher the morning after evening binge alcohol when compared to fluid control condition. A p-value of \< 0.05 was used for significance.|t-test, 2 sided|||Statistical analysis on Burst Incidence (Burst/100hb)||||0.920
70959613|NCT03567434|141423399|SUPERIORITY|The original hypothesis was that sympathetic baroreflex sensitivity would be blunted the morning after evening binge alcohol when compared to fluid control condition. A p-value of \< 0.05 was used for significance.||||||0.888||||||The original hypothesis was that sympathetic baroreflex sensitivity would be blunted the morning after evening binge alcohol when compared to fluid control condition. A p-value of \< 0.05 was used for significance.|t-test, 2 sided|||||||0.888
70959614|NCT03727438|141423510|EQUIVALENCE|alpha = .05|Mean Difference (Final Values)|-3.7|||<|0.01|TWO_SIDED|95.0|-5.0|-2.4||alpha=.05|Mixed Models Analysis|Model parameters included a common intercept (baseline means constrained to be equal), stratification variables, timepoint, and arm by timepoint.||"Analyses were conducted according to the intention-to-treat principle. All available data, including observations from participants who dropped out of the study, were used for primary and secondary analyses. Our modeling estimation approach was conducted with full-likelihood methods, providing unbiased treatment effect estimates under a missing-data framework known as missing at random (MAR)."||-2.4|-5.0|<0.01
70959615|NCT03727438|141423511|EQUIVALENCE|alpha= .05|Mean Difference (Final Values)|-19.6|||<|0.01|TWO_SIDED|95.0|-26.7|-12.5||alpha = 0.05|Mixed Models Analysis|||||-12.5|-26.7|<0.01
70959616|NCT03727438|141423512|EQUIVALENCE|alpha = .05|Mean Difference (Final Values)|-20.6|||<|0.01|TWO_SIDED|95.0|-29.1|-12.0||alpha = .05|Mixed Models Analysis|||||-12.0|-29.1|<0.01
70959617|NCT03727438|141423513|EQUIVALENCE|alpha = .05|Mean Difference (Final Values)|11.0|||<|0.01|TWO_SIDED|95.0|7.7|14.3|||Mixed Models Analysis|alpha = 0.05||||14.3|7.7|<0.01
70959618|NCT03727438|141423514|EQUIVALENCE|Alpha = .05|Mean Difference (Final Values)|-6.2|||>|0.05|TWO_SIDED|95.0|-12.5|0.1||Alpha = .05|Mixed Models Analysis|||||0.1|-12.5|> 0.05
70879890|NCT03760146|141245114|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.71|||||TWO_SIDED|95.0|1.38|2.12||||||Serotype 8: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.12|1.38|
70879891|NCT03760146|141245114|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.62|||||TWO_SIDED|95.0|1.31|2.0||||||Serotype 10A: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.00|1.31|
70879892|NCT03760146|141245114|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.32|||||TWO_SIDED|95.0|1.04|1.68||||||Serotype 11A: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.68|1.04|
70879893|NCT03760146|141245114|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.91|||||TWO_SIDED|95.0|1.51|2.41||||||Serotype 12F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.41|1.51|
70879894|NCT03760146|141245114|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.52|||||TWO_SIDED|95.0|1.13|2.05||||||Serotype 15B: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.05|1.13|
70879895|NCT03760146|141245114|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.69|||||TWO_SIDED|95.0|1.3|2.2||||||Serotype 22F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.20|1.30|
70879896|NCT03760146|141245114|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.4|||||TWO_SIDED|95.0|1.1|1.79||||||Serotype 33F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.79|1.10|
70879897|NCT01464346|141245139|SUPERIORITY_OR_OTHER||Intercept from ANCOVA as agreement rate|88.01|STANDARD_ERROR_OF_MEAN|1.2|<|0.05|TWO_SIDED|95.0|85.69|90.33|||ANCOVA|Mixed effects model was used, with day of sensor wear(1,3 or 6) as covariate. Day was centered to 0 to permit interpretation of the model intercept||||90.33|85.69|<0.05
70879898|NCT01464346|141245140|SUPERIORITY_OR_OTHER||Intercept from ANCOVA as agreement rate|90.52|STANDARD_ERROR_OF_MEAN|0.9|<|0.05|TWO_SIDED|95.0|88.77|92.28|||ANCOVA|Mixed effects model was used, with day of sensor wear(1,3 or 6) as covariate. Day was centered to 0 to permit interpretation of the model intercept||||92.28|88.77|< 0.05
70879899|NCT03245008|141245145|SUPERIORITY||Least Squares Mean Difference|-1.22|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.57|-0.86||Adjusted P-value|Mixed Models Analysis|||||-0.86|-1.57|<0.001
70879900|NCT03245008|141245145|SUPERIORITY||Least Squares Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.21||0.103|TWO_SIDED|95.0|-0.76|0.07||Adjusted P-value|Mixed Models Analysis|||||0.07|-0.76|0.103
70959619|NCT03727438|141423515|EQUIVALENCE|alpha = .05|Mean Difference (Final Values)|0.0|||>|0.05|TWO_SIDED|95.0|-0.4|0.5||alpha =.05|Mixed Models Analysis|||||.5|-.4|>0.05
70959620|NCT03727438|141423516|EQUIVALENCE|alpha = .05|Mean Difference (Final Values)|1.5|||<|0.05|TWO_SIDED|95.0|0.2|2.9||alpha = .05|Mixed Models Analysis|||||2.9|0.2|<0.05
70959621|NCT02647320|141423518|OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.157||0.755|TWO_SIDED|90.0|-0.211|0.309|||Mixed Model Repeated Measure|||Difference in change at week 12||0.309|-0.211|.755
70959622|NCT02647320|141423518|OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.161||0.512|TWO_SIDED|90.0|-0.16|0.371|||Mixed Model Repeated Measure|||Difference in change at week 12||0.371|-0.160|.512
70959623|NCT02647320|141423518|OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.566|TWO_SIDED|90.0|-0.312|0.151|||Mixed Model Repeated Measure|||Difference in change at week 12||0.151|-0.312|.566
70959624|NCT02647320|141423518|OTHER||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.139||0.002|TWO_SIDED|90.0|-0.655|-0.197|||Mixed Model Repeated Measure|||Difference in change at week 12||-0.197|-0.655|.002
70959625|NCT02647320|141423519|OTHER||LS Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|3.13||0.144|TWO_SIDED|90.0|-9.76|0.58|||Mixed Model Repeated Measure|||Difference in change at week 12||0.58|-9.76|.144
70959626|NCT02647320|141423519|OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|3.16||0.773|TWO_SIDED|90.0|-6.14|4.31|||Mixed Model Repeated Measure|||Difference in change at week 12||4.31|-6.14|.773
70959627|NCT02647320|141423519|OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|2.79||0.963|TWO_SIDED|90.0|-4.73|4.48|||Mixed Model Repeated Measure|||Difference in change at week 12||4.48|-4.73|.963
70959628|NCT02647320|141423519|OTHER||LS Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|2.74||0.258|TWO_SIDED|90.0|-7.64|1.42|||Mixed Model Repeated Measure|||Difference in change at week 12||1.42|-7.64|.258
70959629|NCT02647320|141423520|OTHER||LS Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|5.5||0.228|TWO_SIDED|90.0|-15.74|2.43|||Mixed Model Repeated Measure|||Difference in change at week 12||2.43|-15.74|.228
70959630|NCT02647320|141423520|OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|5.51||0.894|TWO_SIDED|90.0|-8.36|9.84|||Mixed Model Repeated Measure|||Difference in change at week 12||9.84|-8.36|.894
70959631|NCT02647320|141423520|OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|4.86||0.846|TWO_SIDED|90.0|-8.97|7.08|||Mixed Model Repeated Measure|||Difference in change at week 12||7.08|-8.97|.846
70959632|NCT02647320|141423520|OTHER||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|4.77||0.409|TWO_SIDED|90.0|-11.82|3.93|||Mixed Model Repeated Measure|||Difference in change at week 12||3.93|-11.82|.409
70959633|NCT02647320|141423521|OTHER||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|2.59||0.576|TWO_SIDED|90.0|-2.83|5.73|||Mixed Model Repeated Measure|||Difference in change at week 12||5.73|-2.83|.576
70959634|NCT02647320|141423521|OTHER||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|2.62||0.646|TWO_SIDED|90.0|-5.53|3.12|||Mixed Model Repeated Measure|||Difference in change at week 12||3.12|-5.53|.646
70959635|NCT02647320|141423521|OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|2.3||0.902|TWO_SIDED|90.0|-3.52|4.08|||Mixed Model Repeated Measure|||Difference in change at week 12||4.08|-3.52|.902
70959636|NCT02647320|141423521|OTHER||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|2.27||0.478|TWO_SIDED|90.0|-5.35|2.13|||Mixed Model Repeated Measure|||Difference in change at week 12||2.13|-5.35|.478
70959637|NCT02647320|141423522|OTHER||LS Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|4.22||0.072|TWO_SIDED|90.0|-14.57|-0.64|||Mixed Model Repeated Measure|||Difference in change at week 12||-0.64|-14.57|.072
70959638|NCT02647320|141423522|OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|4.26||0.794|TWO_SIDED|90.0|-8.15|5.92|||Mixed Model Repeated Measure|||Difference in change at week 12||5.92|-8.15|.794
70959639|NCT02647320|141423522|OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|3.75||0.946|TWO_SIDED|90.0|-6.45|5.94|||Mixed Model Repeated Measure|||Difference in change at week 12||5.94|-6.45|.946
70959640|NCT02647320|141423522|OTHER||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|3.68||0.431|TWO_SIDED|90.0|-8.99|3.18|||Mixed Model Repeated Measure|||Difference in change at week 12||3.18|-8.99|.431
70959641|NCT02647320|141423523|OTHER||LS Mean Difference|-10.3|STANDARD_ERROR_OF_MEAN|8.54||0.228|TWO_SIDED|90.0|-24.43|3.78|||Mixed Model Repeated Measure|||Difference in change at week 12||3.78|-24.43|.228
70959642|NCT02647320|141423523|OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|8.62||0.951|TWO_SIDED|90.0|-13.7|14.77|||Mixed Model Repeated Measure|||Difference in change at week 12||14.77|-13.70|.951
70959643|NCT02647320|141423523|OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|7.59||0.852|TWO_SIDED|90.0|-13.96|11.13|||Mixed Model Repeated Measure|||Difference in change at week 12||11.13|-13.96|.852
70959644|NCT02647320|141423523|OTHER||LS Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|7.45||0.608|TWO_SIDED|90.0|-16.13|8.48|||Mixed Model Repeated Measure|||Difference in change at week 12||8.48|-16.13|.608
70959645|NCT02647320|141423524|OTHER||LS Mean Difference|5.32|STANDARD_ERROR_OF_MEAN|15.289||0.728|TWO_SIDED|90.0|-19.932|30.566|||Mixed Model Repeated Measure|||Difference in change at week 4||30.566|-19.932|.728
70959646|NCT02647320|141423524|OTHER||LS Mean Difference|-3.27|STANDARD_ERROR_OF_MEAN|15.853||0.837|TWO_SIDED|90.0|-29.446|22.914|||Mixed Model Repeated Measure|||Difference in change at week 4||22.914|-29.446|.837
70959647|NCT02647320|141423524|OTHER||LS Mean Difference|-3.65|STANDARD_ERROR_OF_MEAN|13.747||0.791|TWO_SIDED|90.0|-26.352|19.051|||Mixed Model Repeated Measure|||Difference in change at week 4||19.051|-26.352|.791
70959648|NCT02647320|141423524|OTHER||LS Mean Difference|-40.03|STANDARD_ERROR_OF_MEAN|13.472||0.003|TWO_SIDED|90.0|-62.283|-17.787|||Mixed Model Repeated Measure|||Difference in change at week 4||-17.787|-62.283|.003
70959649|NCT02647320|141423525|OTHER||LS Mean Difference|4.39|STANDARD_ERROR_OF_MEAN|20.396||0.83|TWO_SIDED|90.0|-29.312|38.087|||Mixed Model Repeated Measure|||Difference in change at week 12||38.087|-29.312|.830
70959650|NCT02647320|141423525|OTHER||LS Mean Difference|24.25|STANDARD_ERROR_OF_MEAN|20.335||0.235|TWO_SIDED|90.0|-9.354|57.848|||Mixed Model Repeated Measure|||Difference in change at week 12||57.848|-9.354|.235
70959651|NCT02647320|141423525|OTHER||LS Mean Difference|17.25|STANDARD_ERROR_OF_MEAN|17.72||0.331|TWO_SIDED|90.0|-12.03|46.529|||Mixed Model Repeated Measure|||Difference in change at week 12||46.529|-12.030|.331
70959652|NCT02647320|141423525|OTHER||LS Mean Difference|-29.51|STANDARD_ERROR_OF_MEAN|17.393||0.091|TWO_SIDED|90.0|-58.254|-0.775|||Mixed Model Repeated Measure|||Difference in change at week 12||-0.775|-58.254|.091
70959653|NCT02647320|141423526|OTHER||LS Mean Difference|1.49|STANDARD_ERROR_OF_MEAN|9.28||0.873|TWO_SIDED|90.0|-13.835|16.815|||Mixed Model Repeated Measure|||Difference in change at week 4||16.815|-13.835|.873
70959654|NCT02647320|141423526|OTHER||LS Mean Difference|-8.09|STANDARD_ERROR_OF_MEAN|9.505||0.395|TWO_SIDED|90.0|-23.79|7.604|||Mixed Model Repeated Measure|||Difference in change at week 4||7.604|-23.790|.395
70959655|NCT02647320|141423526|OTHER||LS Mean Difference|-2.53|STANDARD_ERROR_OF_MEAN|8.306||0.761|TWO_SIDED|90.0|-16.247|11.185|||Mixed Model Repeated Measure|||Difference in change at week 4||11.185|-16.247|.761
70959656|NCT02647320|141423526|OTHER||LS Mean Difference|-27.73|STANDARD_ERROR_OF_MEAN|8.17|<|0.001|TWO_SIDED|90.0|-41.22|-14.236|||Mixed Model Repeated Measure|||Difference in change at week 4||-14.236|-41.220|<0.001
70959657|NCT02647320|141423527|OTHER||LS Mean Difference|-7.61|STANDARD_ERROR_OF_MEAN|12.001||0.527|TWO_SIDED|90.0|-27.441|12.221|||Mixed Model Repeated Measure|||Difference in change at week 12||12.221|-27.441|.527
70959658|NCT02647320|141423527|OTHER||LS Mean Difference|-7.39|STANDARD_ERROR_OF_MEAN|0.532||0.532|TWO_SIDED|90.0|-26.927|12.138|||Mixed Model Repeated Measure|||Difference in change at week 12||12.138|-26.927|.532
70959659|NCT02647320|141423527|OTHER||LS Mean Difference|-4.41|STANDARD_ERROR_OF_MEAN|10.421||0.672|TWO_SIDED|90.0|-21.635|12.807|||Mixed Model Repeated Measure|||Difference in change at week 12||12.807|-21.635|.672
70959660|NCT02647320|141423527|OTHER||LS Mean Difference|-31.58|STANDARD_ERROR_OF_MEAN|10.229||0.002|TWO_SIDED|90.0|-48.482|-14.676|||Mixed Model Repeated Measure|||Difference in change at week 12||-14.676|-48.482|.002
70959661|NCT02647320|141423528|OTHER||LS Mean Difference|-6.2|STANDARD_ERROR_OF_MEAN|5.9||0.298|TWO_SIDED|90.0|-15.9|3.6|||Mixed Model Repeated Measure|||Difference in change at week 2||3.60|-15.90|.298
70959662|NCT02647320|141423528|OTHER||LS Mean Difference|-16.3|STANDARD_ERROR_OF_MEAN|6.09||0.008|TWO_SIDED|90.0|-26.37|-6.27|||Mixed Model Repeated Measure|||Difference in change at week 2||-6.27|-26.37|.008
70959663|NCT02647320|141423528|OTHER||LS Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|5.32||0.074|TWO_SIDED|90.0|-18.31|-0.75|||Mixed Model Repeated Measure|||Difference in change at week 2||-0.75|-18.31|.074
70959664|NCT02647320|141423528|OTHER||LS Mean Difference|-27.2|STANDARD_ERROR_OF_MEAN|5.32|<|0.001|TWO_SIDED|90.0|-35.96|-18.38|||Mixed Model Repeated Measure|||Difference in change at week 2||-18.38|-35.96|<0.001
70959665|NCT02647320|141423529|OTHER||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|5.96||0.84|TWO_SIDED|90.0|-11.04|8.63|||Mixed Model Repeated Measure|||Difference in change at week 4||8.63|-11.04|.840
70959666|NCT02647320|141423529|OTHER||LS Mean Difference|-11.9|STANDARD_ERROR_OF_MEAN|6.06||0.05|TWO_SIDED|90.0|-21.94|-1.91|||Mixed Model Repeated Measure|||Difference in change at week 4||-1.91|-21.94|.050
70959667|NCT02647320|141423529|OTHER||LS Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|5.31||0.227|TWO_SIDED|90.0|-15.21|2.33|||Mixed Model Repeated Measure|||Difference in change at week 4||2.33|-15.21|.227
70959668|NCT02647320|141423529|OTHER||LS Mean Difference|-13.1|STANDARD_ERROR_OF_MEAN|5.27||0.13|TWO_SIDED|90.0|-21.83|-4.43|||Mixed Model Repeated Measure|||Difference in change at week 4||-4.43|-21.83|0.13
70959669|NCT02647320|141423530|OTHER||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|6.55||0.642|TWO_SIDED|90.0|-7.77|13.88|||Mixed Model Repeated Measure|||Difference in change at week 8||13.88|-7.77|.642
70959670|NCT02647320|141423530|OTHER||LS Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|6.72||0.512|TWO_SIDED|90.0|-15.52|6.68|||Mixed Model Repeated Measure|||Difference in change at week 8||6.68|-15.52|.512
70959671|NCT02647320|141423530|OTHER||LS Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|5.81||0.486|TWO_SIDED|90.0|-13.66|5.54|||Mixed Model Repeated Measure|||Difference in change at week 8||5.54|-13.66|.486
70959672|NCT02647320|141423530|OTHER||LS Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|5.8||0.004|TWO_SIDED|90.0|-26.31|-7.16|||Mixed Model Repeated Measure|||Difference in change at week 8||-7.16|-26.31|.004
70959673|NCT02647320|141423531|OTHER||LS Mean Difference|-8.7|STANDARD_ERROR_OF_MEAN|8.11||0.285|TWO_SIDED|90.0|-22.09|4.7|||Mixed Model Repeated Measure|||Difference in change at week 12||4.70|-22.09|.285
70959674|NCT02647320|141423531|OTHER||LS Mean Difference|-18.6|STANDARD_ERROR_OF_MEAN|7.94||0.02|TWO_SIDED|90.0|-31.73|-5.49|||Mixed Model Repeated Measure|||Difference in change at week 12||-5.49|-31.73|.020
70879901|NCT03245008|141245146|SUPERIORITY||Least Squares Mean Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.6|-0.92||Adjusted P-value|Mixed Models Analysis|||||-0.92|-1.60|<0.001
70879902|NCT03245008|141245146|SUPERIORITY||Least Squares Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.84|-0.05||||||||-0.05|-0.84|
70879903|NCT01286012|141245156|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
70879904|NCT01286012|141245157|SUPERIORITY_OR_OTHER|||||||0.915|||||||Cochran-Mantel-Haenszel|||||||0.915
70879905|NCT01286012|141245158|SUPERIORITY_OR_OTHER|||||||0.6714|||||||Cochran-Mantel-Haenszel|||||||0.6714
70959675|NCT02647320|141423531|OTHER||LS Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|7.03||0.067|TWO_SIDED|90.0|-24.6|-1.35|||Mixed Model Repeated Measure|||Difference in change at week 12||-1.35|-24.60|.067
70959676|NCT02647320|141423531|OTHER||LS Mean Difference|-17.4|STANDARD_ERROR_OF_MEAN|6.88||0.012|TWO_SIDED|90.0|-28.76|-6.03|||Mixed Model Repeated Measure|||Difference in change at week 12||-6.03|-28.76|.012
70959677|NCT03435497|141423548|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions in which the response may have come from either follow-up, and the predictors were an indicator for study arm, the baseline value of the outcome, the follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.017|TWO_SIDED||||||Regression, Linear|||||||.017
70959678|NCT03435497|141423549|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical logistic repeated-measures regressions in which the response may have come from either follow-up, and the predictors were an indicator for study arm, the baseline value of the outcome, the follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Net)|0.5||||0.05|TWO_SIDED|95.0|0.2|1.6|||Regression, Logistic|||||1.6|0.2|.05
70959679|NCT03435497|141423550|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions in which the response may have come from either follow-up, and the predictors were an indicator for study arm, the baseline value of the outcome, the follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.48|TWO_SIDED||||||Regression, Linear|||||||0.48
70959680|NCT03435497|141423551|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions in which the response may have come from either follow-up, and the predictors were an indicator for study arm, the baseline value of the outcome, the follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.012|TWO_SIDED||||||Regression, Linear|||||||0.012
70959681|NCT03435497|141423552|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical logistic repeated-measures regressions in which the response may have come from either follow-up, and the predictors were an indicator for study arm, the baseline value of the outcome, the follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Odds Ratio (OR)|10.0||||0.022|TWO_SIDED|95.0|1.5|67.7|||Regression, Logistic|||||67.7|1.5|0.022
70959682|NCT01468831|141423586|OTHER|The mean difference between the minocycline and placebo arms in change in BCVA in the study eye at Month 12 compared to baseline is reported.|Mean Difference (Net)|7.8|STANDARD_DEVIATION|7.4|||TWO_SIDED|95.0|-10.6|26.1|||||Difference = Minocycline - Placebo|||26.1|-10.6|
70959683|NCT01468831|141423587|OTHER|The mean difference between the minocycline and placebo treatment arms in number of bevacizumab injections received from baseline to Month 12 is reported.|Mean Difference (Net)|1.1|STANDARD_DEVIATION|1.4|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
70959684|NCT01468831|141423588|OTHER||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|3.5|||TWO_SIDED||||||||Difference = Minocycline - Placebo|The mean difference between the minocycline and placebo treatment arms in number of bevacizumab injections received from baseline to Month 24 is reported.||||
70959685|NCT01468831|141423589|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 3 compared to baseline is reported.|Mean Difference (Net)|-0.8|STANDARD_DEVIATION|1.3|||TWO_SIDED|95.0|-3.9|2.3|||||Difference = Minocycline - Placebo|||2.3|-3.9|
70959686|NCT01468831|141423590|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 6 compared to baseline is reported.|Mean Difference (Net)|-2.1|STANDARD_DEVIATION|1.0|||TWO_SIDED|95.0|-4.5|0.3|||||Difference = Minocycline - Placebo|||0.3|-4.5|
70959687|NCT01468831|141423591|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 12 compared to baseline is reported.|Mean Difference (Net)|-2.5|STANDARD_DEVIATION|1.8|||TWO_SIDED|95.0|-7.5|2.5|||||Difference = Minocycline - Placebo|||2.5|-7.5|
70879906|NCT01286012|141245159|SUPERIORITY_OR_OTHER|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
70959688|NCT01468831|141423592|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 18 compared to baseline is reported.|Mean Difference (Net)|-3.5|STANDARD_DEVIATION|2.2|||TWO_SIDED|95.0|-9.4|2.4|||||Difference = Minocycline - Placebo|||2.4|-9.4|
70959689|NCT01468831|141423593|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 24 compared to baseline is reported.|Mean Difference (Net)|-3.7|STANDARD_DEVIATION|2.4|||TWO_SIDED|95.0|-9.5|2.0|||||Difference = Minocycline - Placebo|||2|-9.5|
70879907|NCT01286012|141245160|SUPERIORITY_OR_OTHER|||||||0.361|||||||Wilcoxon (Mann-Whitney)|||||||0.361
70879908|NCT01064401|141245162|SUPERIORITY_OR_OTHER||Rate Ratio|0.55|||<|0.0001|TWO_SIDED|95.0|0.469|0.645||Estimated from a negative binomial regression model adjusted for the baseline relapse rate, history of prior IFN beta use, baseline EDSS (≤ 2.5 vs \> 2.5) and baseline age (≤ 35 vs \> 35 years).|Negative Binomial Regression|||||0.645|0.469|< 0.0001
70879909|NCT01064401|141245162|SUPERIORITY_OR_OTHER||Percent Reduction|45.0|||||TWO_SIDED|95.0|35.5|53.1||||||||53.1|35.5|
70879910|NCT01064401|141245163|SUPERIORITY_OR_OTHER||Percent Reduction|54.4|||<|0.0001|TWO_SIDED|95.0|46.9|60.8||Estimated from a negative binomial regression model, adjusted for baseline volume of T2 hyperintense lesions, history of prior IFN beta use and baseline age (≤ 35 vs \> 35 years).|Negative Binomial Regression|The logarithmic transformation of the scan number of the MRI assessment was included in the model as the 'offset' parameter.||||60.8|46.9|< 0.0001
70879911|NCT01064401|141245164|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.84||||0.1575|TWO_SIDED|95.0|0.66|1.07||Based on Cox Proportional Hazards model, adjusted by baseline EDSS values as continuous variable, history of prior IFN beta use, and baseline age (≤ 35 vs \> 35 years).|Cox Proportional Hazard|||||1.07|0.66|0.1575
70879912|NCT01064401|141245164|SUPERIORITY_OR_OTHER||Percent Reduction|16.1|||||TWO_SIDED|95.0|-7.0|34.2||||||||34.2|-7.0|
70879913|NCT01064401|141245165|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.59|||<|0.0001|TWO_SIDED|95.0|0.5|0.69||Based on Cox proportional hazards model, adjusted for baseline relapse rate, history of prior IFN beta use, baseline EDSS (EDSS ≤ 2.5 vs EDSS \> 2.5) and baseline age (≤ 35 vs \> 35 years).|Cox Proportional Hazard|||||0.69|0.50|< 0.0001
70879914|NCT01064401|141245165|SUPERIORITY_OR_OTHER||Percent Reduction in Risk of Relapse|40.9|||||TWO_SIDED|95.0|30.8|49.5||||||||49.5|30.8|
70879915|NCT01064401|141245166|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.0176|TWO_SIDED|95.0|0.6|0.95||Based on logistic regression model, adjusted for baseline MSIS-29 physical score, baseline Beck Depression Inventory (BDI) score, history of prior IFN beta use, and baseline age (≤ 35 vs \> 35 years).|Regression, Logistic|||||0.95|0.60|0.0176
70879916|NCT01064401|141245166|SUPERIORITY_OR_OTHER||Percent Reduction in Odds of Worsening|24.2|||||TWO_SIDED|95.0|4.7|39.6||||||||39.6|4.7|
70959690|NCT01468831|141423594|OTHER|The mean difference between the minocycline and placebo arms in change in BCVA in the study eye at Month 24 compared to baseline is reported.|Mean Difference (Net)|5.8|STANDARD_DEVIATION|9.1|||TWO_SIDED|95.0|-17.1|28.6|||||Difference = Minocycline - Placebo|||28.6|-17.1|
70959691|NCT01468831|141423595|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 6 compared to baseline is reported.|Mean Difference (Net)|-51.8|STANDARD_DEVIATION|70.8|||TWO_SIDED|95.0|-231.2|127.6|||||Difference = Minocycline - Placebo|||127.6|-231.2|
70879917|NCT02117999|141245175|NON_INFERIORITY|Sample size calculation was performed to detect a difference of 0.95 D between the average Kmax changes for the T-ionto CL and standard CL groups at 12 months, at a significance level of 5% and a power of 81%, assuming a standard deviation of 1.20 D.|||||<|0.05|||||||ANOVA|||Analysis of changes from baseline in each group was made using the paired Student t-test. Treatment effects were assessed using repeated measures ANOVA between groups and time (3 days, 7 days, 1-, 3-, 6- and 12-months). The outcome measures over time were corrected for baseline values. The relationship between the change in Kmax at 12 months and baseline parameters was assessed using Pearson's correlation analysis for either group.||||<0.05
70879918|NCT02117999|141245176|NON_INFERIORITY|sample size calculation was performed to detect a difference of 0.95 D between the average Kmax changes for the T-ionto CL and standard CL groups at 12 months, at a significance level of 5% and a power of 81%, assuming a standard deviation of 1.20 D. The sample size of the study was 34 cases (allocation ratio of 2:1)|Mean Difference (Final Values)|35.0||||0.05|TWO_SIDED||||||ANOVA|||Analysis of changes from baseline in each group was made using the paired Student t-test. Treatment effects were assessed using repeated measures ANOVA between groups and time (3 days, 7 days, 1-, 3-, 6- and 12-months). The outcome measures over time were corrected for baseline values.||||0.05
70879919|NCT01536379|141245196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-34.4|STANDARD_ERROR_OF_MEAN|37.24|||TWO_SIDED|95.0|-109.5|40.7||||||||40.7|-109.5|
70879920|NCT01536379|141245217|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|204.35|||||TWO_SIDED|95.0|90.0|550.0|||||Week 24 comparison|||550.00|90.00|
70879921|NCT01536379|141245217|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-33.06|||||TWO_SIDED|95.0|-169.84|25.0|||||Week 52 comparison|||25.00|-169.84|
70879922|NCT01536379|141245218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1232.4|STANDARD_ERROR_OF_MEAN|25735.56|||TWO_SIDED|95.0|-50457.0|52921.8|||||Week 24 comparison|||52921.8|-50457.0|
70879923|NCT01536379|141245218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13128.35|STANDARD_ERROR_OF_MEAN|24165.18|||TWO_SIDED|95.0|-61868.9|35612.2|||||Week 52 comparison|||35612.2|-61868.9|
70879924|NCT01536379|141245219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.8|STANDARD_ERROR_OF_MEAN|8.78|||TWO_SIDED|95.0|-31.3|3.7|||||Week 24 comparison|||3.7|-31.3|
70879925|NCT01536379|141245219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8|STANDARD_ERROR_OF_MEAN|7.68|||TWO_SIDED|95.0|-8.6|22.2|||||Week 52 comparison|||22.2|-8.6|
70879926|NCT01536379|141245220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2791.0|STANDARD_ERROR_OF_MEAN|4651.1|||TWO_SIDED|95.0|-12105.0|6524.0|||||Week 24 comparison|||6524|-12105|
70879927|NCT01536379|141245220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-458.0|STANDARD_ERROR_OF_MEAN|4501.8|||TWO_SIDED|95.0|-9487.0|8572.0|||||Week 52 comparison|||8572|-9487|
70879928|NCT01536379|141245221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|1.156|||TWO_SIDED|95.0|-3.59|1.01|||||Week 24 comparison|||1.01|-3.59|
70879929|NCT01536379|141245221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|1.017|||TWO_SIDED|95.0|-1.24|2.82|||||Week 52 comparison|||2.82|-1.24|
70879930|NCT01536379|141245222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30326.9|STANDARD_ERROR_OF_MEAN|34677.86|||TWO_SIDED|95.0|-100559.1|39905.3|||||Week 24 comparison|||39905.3|-100559.1|
70879931|NCT01536379|141245222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46955.3|STANDARD_ERROR_OF_MEAN|32594.81|||TWO_SIDED|95.0|-113218.9|19308.3|||||Week 52 comparison|||19308.3|-113218.9|
70879932|NCT01536379|141245223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|3.54|||TWO_SIDED|95.0|-10.1|4.2|||||Week 24 comparison|||4.2|-10.1|
70959692|NCT01468831|141423596|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 12 compared to baseline is reported.|Mean Difference (Net)|-45.5|STANDARD_DEVIATION|153.5|||TWO_SIDED|95.0|-522.6|431.6|||||Difference = Minocycline - Placebo|||431.6|-522.6|
70959693|NCT01468831|141423597|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 18 compared to baseline is reported.|Mean Difference (Net)|-12.8|STANDARD_DEVIATION|163.8|||TWO_SIDED|95.0|-513.1|487.6|||||Difference = Minocycline - Placebo|||487.6|-513.1|
70959694|NCT01468831|141423598|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 24 compared to baseline is reported.|Mean Difference (Net)|-9.5|STANDARD_DEVIATION|156.8|||TWO_SIDED|95.0|-487.0|468.0|||||Difference = Minocycline - Placebo|||468|-487|
70959695|NCT01468831|141423599|OTHER|The difference between the minocycline and placebo treatment arms in number of participants improving ≥ 1 logOCT scale step in the study eye at Month 12 compared to baseline is reported.|Difference in Number of Participants|1.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
70959696|NCT01468831|141423600|OTHER|The difference between the minocycline and placebo treatment arms in number of participants improving ≥ 1 logOCT scale step in the study eye at Month 24 compared to baseline is reported|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
70959697|NCT01468831|141423601|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing a decrease in fluid leakage at Month 12 compared to baseline is reported.|Difference in Number of Participants|-2.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
70959698|NCT01468831|141423601|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing an increase in fluid leakage at Month 12 compared to baseline is reported.|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
70959699|NCT01468831|141423601|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing no change in fluid leakage at Month 12 compared to baseline is reported.|Difference in Number of Participants|2.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
70959700|NCT01468831|141423602|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing a decrease in fluid leakage at Month 24 compared to baseline is reported.|Difference in Number of Participants|-1.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
70959701|NCT01468831|141423602|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing an increase in fluid leakage at Month 24 compared to baseline is reported.|Difference in Number of Participants|1.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
70959702|NCT01468831|141423602|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing no change in fluid leakage at Month 24 compared to baseline is reported.|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
70959703|NCT01037244|141423604|SUPERIORITY_OR_OTHER||Difference in Least Square (LS) Means|5.04|||<|0.0001|TWO_SIDED|95.0|3.36|6.73|||ANCOVA|Baseline Domain Score and pooled sites as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||6.73|3.36|<0.0001
70959704|NCT01037244|141423604|SUPERIORITY_OR_OTHER||Difference in LS Means|7.18|||<|0.0001|TWO_SIDED|95.0|5.49|8.86|||ANCOVA|Baseline domain score and pooled sites as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||8.86|5.49|<0.0001
70959705|NCT01037244|141423604|SUPERIORITY_OR_OTHER||Difference in LS Means|7.95|||<|0.0001|TWO_SIDED|95.0|6.27|9.63|||ANCOVA|Baseline domain score and pooled sites as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||9.63|6.27|<0.0001
70959706|NCT01037244|141423605|SUPERIORITY_OR_OTHER||Difference in LS Means|18.6|||<|0.0001|TWO_SIDED|95.0|11.72|25.48|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||25.48|11.72|<0.0001
70959707|NCT01037244|141423605|SUPERIORITY_OR_OTHER||Difference in LS Means|29.02|||<|0.0001|TWO_SIDED|95.0|22.13|35.9|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||35.90|22.13|<0.0001
70879933|NCT01536379|141245223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|3.35|||TWO_SIDED|95.0|-7.2|6.3|||||Week 52 comparison|||6.3|-7.2|
70879934|NCT01536379|141245224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|648.3|STANDARD_ERROR_OF_MEAN|12618.44|||TWO_SIDED|95.0|-24661.1|25957.7|||||Week 24 comparison|||25957.7|-24661.1|
70879935|NCT01536379|141245224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5618.9|STANDARD_ERROR_OF_MEAN|12153.03|||TWO_SIDED|95.0|-29994.8|18757.0|||||Week 52 comparison|||18757.0|-29994.8|
70959708|NCT01037244|141423605|SUPERIORITY_OR_OTHER||Difference in LS Means|31.51|||<|0.0001|TWO_SIDED|95.0|24.68|38.34|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||38.34|24.68|<0.0001
70959709|NCT01037244|141423606|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Armitage test|||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||||<0.0001
70959710|NCT01037244|141423606|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||||<0.0001
70959711|NCT01037244|141423606|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||||<0.0001
70879936|NCT01536379|141245225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|1.67|||TWO_SIDED|95.0|-3.2|3.5|||||Week 24 comparison|||3.5|-3.2|
70959712|NCT01037244|141423606|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||||<0.0001
70959713|NCT01037244|141423607|SUPERIORITY_OR_OTHER||Difference in LS Means|0.44|||<|0.0001|TWO_SIDED|95.0|0.3|0.59|||ANCOVA|p-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||0.59|0.30|<0.0001
70879937|NCT01536379|141245225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|95.0|-3.5|2.3|||||Week 52 comparison|||2.3|-3.5|
70879938|NCT01536379|141245226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|1.255|||TWO_SIDED|95.0|-4.07|0.98|||||Week 24 comparison|||0.98|-4.07|
70879939|NCT01536379|141245226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|1.329|||TWO_SIDED|95.0|-3.68|1.67|||||Week 52 comparison|||1.67|-3.68|
70879940|NCT01536379|141245227|SUPERIORITY_OR_OTHER||Difference in Proportion|-0.067|||||TWO_SIDED|95.0|-0.638|0.505|||||Week 24 comparison|||0.505|-0.638|
70879941|NCT01536379|141245227|SUPERIORITY_OR_OTHER||Difference in Proportion|-0.267|||||TWO_SIDED|95.0|-0.838|0.305|||||Week 52 comparison|||0.305|-0.838|
70879942|NCT01536379|141245228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8|STANDARD_ERROR_OF_MEAN|52.06|||TWO_SIDED|95.0|-105.9|100.3|||||Week 24 comparison|||100.3|-105.9|
70879943|NCT01536379|141245228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.9|STANDARD_ERROR_OF_MEAN|47.52|||TWO_SIDED|95.0|-107.1|81.4|||||Week 52 comparison|||81.4|-107.1|
70879944|NCT01536379|141245229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.92|STANDARD_ERROR_OF_MEAN|9.44|||TWO_SIDED|95.0|-31.56|5.71|||||Week 24 comparison|||5.71|-31.56|
70879945|NCT01536379|141245229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|8.315|||TWO_SIDED|95.0|-19.11|13.72|||||Week 52 comparison|||13.72|-19.11|
70879946|NCT01536379|141245230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|2.225|||TWO_SIDED|95.0|-4.84|3.96||||||||3.96|-4.84|
70879947|NCT03971695|141245241|OTHER||Adjusted geometric mean (gMean) ratio(%)|100.26|||||TWO_SIDED|90.0|90.18|111.48|||||Intra-individual geometric coefficient of variance (gCV) = 14.2. Ratio is T1/R.|Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.||111.48|90.18|
70879948|NCT03971695|141245241|OTHER||Adjusted geometric mean (gMean) ratio(%)|91.63|||||TWO_SIDED|90.0|85.37|98.35|||||Intra-individual geometric coefficient of variance (gCV) = 9.5. Ratio is T2/T1.|Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.||98.35|85.37|
70879949|NCT03971695|141245242|OTHER||Adjusted geometric mean (gMean) ratio(%)|98.01|||||TWO_SIDED|90.0|84.2|114.08|||||Intra-individual geometric coefficient of variance (gCV) = 20.5. Ratio is T1/R.|Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.||114.08|84.20|
70879950|NCT03971695|141245242|OTHER||Adjusted geometric mean (gMean) ratio(%)|77.52|||||TWO_SIDED|90.0|68.11|88.22|||||Intra-individual geometric coefficient of variance (gCV) = 17.4. Ratio is T2/T1.|Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.||88.22|68.11|
70879951|NCT03971695|141245246|OTHER||Adjusted geometric mean (gMean) ratio(%)|96.42|||||TWO_SIDED|90.0|86.96|106.9|||||Intra-individual geometric coefficient of variance (gCV) = 13.9. Ratio is T1/R.|Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.||106.90|86.96|
70879952|NCT03971695|141245246|OTHER||Adjusted geometric mean (gMean) ratio(%)|91.27|||||TWO_SIDED|90.0|85.4|97.54|||||Intra-individual geometric coefficient of variance (gCV) = 8.9. Ratio is T2/T1.|Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.||97.54|85.40|
70959714|NCT01037244|141423607|SUPERIORITY_OR_OTHER||Difference in LS Means|0.68|||<|0.0001|TWO_SIDED|95.0|0.54|0.83|||ANCOVA|p-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||0.83|0.54|<0.0001
70959715|NCT01037244|141423607|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8|||<|0.0001|TWO_SIDED|95.0|0.66|0.95|||ANCOVA|p-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||0.95|0.66|<0.0001
70959716|NCT01037244|141423608|SUPERIORITY_OR_OTHER||Difference in LS Means|16.67|||<|0.0001|TWO_SIDED|95.0|11.23|22.11|||ANOVA|p-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||22.11|11.23|<0.0001
70959717|NCT01037244|141423608|SUPERIORITY_OR_OTHER||Difference in LS Means|22.57|||<|0.0001|TWO_SIDED|95.0|17.11|28.03|||ANOVA|p-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||28.03|17.11|<0.0001
70959718|NCT01037244|141423608|SUPERIORITY_OR_OTHER||Difference in LS Means|28.39|||<|0.0001|TWO_SIDED|95.0|22.98|33.79|||ANOVA|p-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||33.79|22.98|<0.0001
70959719|NCT01037244|141423609|SUPERIORITY_OR_OTHER||Difference in LS Means|1.89|||<|0.0001|TWO_SIDED|95.0|1.17|2.61|||ANCOVA|P-values were obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.61|1.17|<0.0001
70959720|NCT01037244|141423609|SUPERIORITY_OR_OTHER||Difference in LS Means|2.27|||<|0.0001|TWO_SIDED|95.0|1.54|2.99|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.99|1.54|<0.0001
70959721|NCT01037244|141423609|SUPERIORITY_OR_OTHER||Difference in LS Means|3.02|||<|0.0001|TWO_SIDED|95.0|2.3|3.73|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||3.73|2.30|<0.0001
70959722|NCT01037244|141423610|SUPERIORITY_OR_OTHER||Difference in LS Means|1.42|||<|0.0001|TWO_SIDED|95.0|0.81|2.03|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.03|0.81|<0.0001
70879953|NCT04447417|141245247|OTHER||Point estimate|0.43|||<=|0.0001|TWO_SIDED|90.0|0.37|0.49||One-sided p-value. Threshold for significance at 0.05 level.|linear mixed model||Point estimate obtained was back-transformed by exponentiation|TEWL data for linear mixed model was log-transformed to account for right skewness of data and heteroskedasticity. The linear mixed effect on log (TEWL) included age, sex, number of STS, localization on the body, visit, number of STS-by-visit interaction and number of STS-by-age interaction as fixed effects. Model was run on data on lesional skin area.||0.49|0.37|<=0.0001
70959723|NCT01037244|141423610|SUPERIORITY_OR_OTHER||Difference in LS Means|1.65|||<|0.0001|TWO_SIDED|95.0|1.04|2.26|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.26|1.04|<0.0001
70959724|NCT01037244|141423610|SUPERIORITY_OR_OTHER||Difference in LS Means|1.98|||<|0.0001|TWO_SIDED|95.0|1.37|2.59|||ANCOVA|P-values are obtained from ANCOVA model with baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.59|1.37|<0.0001
70959725|NCT01037244|141423611|SUPERIORITY_OR_OTHER||Difference in LS Means|0.57||||0.0019|TWO_SIDED|95.0|0.21|0.93|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||0.93|0.21|0.0019
70959726|NCT01037244|141423611|SUPERIORITY_OR_OTHER||Difference in LS Means|0.74|||<|0.0001|TWO_SIDED|95.0|0.38|1.1|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||1.10|0.38|<0.0001
70959727|NCT01037244|141423611|SUPERIORITY_OR_OTHER||Difference in LS Means|0.85|||<|0.0001|TWO_SIDED|95.0|0.49|1.21|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||1.21|0.49|<0.0001
70959728|NCT01037244|141423612|SUPERIORITY_OR_OTHER||Difference in LS Means|1.66|||<|0.0001|TWO_SIDED|95.0|1.13|2.19|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.19|1.13|<0.0001
70959729|NCT01037244|141423612|SUPERIORITY_OR_OTHER||Difference in LS Means|1.76|||<|0.0001|TWO_SIDED|95.0|1.23|2.29|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.29|1.23|<0.0001
70879954|NCT01280552|141245283|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||Stratified for age and MGMT methylation status|Log Rank|||Stratified log rank p value stratified for age and MGMT methylation status||||0.010
70879955|NCT01280552|141245285|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|||||Analyses were stratified for age and MGMT methylation status.|Log Rank|||||||0.033
70879956|NCT02155738|141245286|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Aim 1: Quantify the impact of IV acetaminophen on 1a) postoperative pain scores ... 1a) To achieve this aim, we will measure the degree of postoperative pain using visual analog scales (VAS) at multiple specified time points throughout the postoperative period; we report on change from Baseline VAS at 24 Hours Postop. Null Hypothesis is that there is no difference between subgroups in VAS scores. Sample size was determined considering significant differences in VAS scores.||||<0.05
70879957|NCT02155738|141245287|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||1b) We will use equianalgesic dosage tables to convert intra- and postoperative narcotics into morphine equivalents to compare narcotic requirements for the first week after surgery. We hypothesize that those patients receiving preemptive IV acetaminophen will have lower postoperative VAS scores and reduced narcotic requirements compared to placebo.||||<0.05
70879958|NCT01190254|141245289|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares (LS) Means|-4.8||||0.07|TWO_SIDED|95.0|-9.9|0.4||p-value is adjusted by Hochberg's method for testing two asenapine groups versus the placebo group|Mixed Model for Repeated Measures (MMRM)|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.4|-9.9|0.070
70879959|NCT01190254|141245289|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-5.6||||0.064|TWO_SIDED|95.0|-10.7|-0.5||p-value is adjusted by Hochberg's method for testing two asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||-0.5|-10.7|0.064
70879960|NCT01190254|141245289|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064||||||p-value (adjusted to control Type I error in multiple testing) for Linear dose-response pattern (Placebo\<2.5 mg\<5.0 mg)|MMRM|||Investigation of dose-response relationship of change from baseline to Day 56 in PANSS Total Score was a Secondary study endpoint. Multiple contrast testing using MMRM model was used to evaluate 3 pre-defined dose-response patterns (Linear, Convex, Concave)||||0.064
70879961|NCT01190254|141245289|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046||||||p-value (adjusted to control Type I error in multiple testing) for Convex dose-response pattern (Placebo\<2.5 mg=5.0 mg)|MMRM|||Investigation of dose-response relationship of change from baseline to Day 56 in PANSS Total Score was a Secondary study endpoint. Multiple contrast testing using MMRM model was used to evaluate 3 pre-defined dose-response patterns (Linear, Convex, Concave)||||0.046
70879962|NCT01190254|141245289|SUPERIORITY_OR_OTHER_LEGACY|||||||0.273||||||p-value (adjusted to control Type I error in multiple testing) for Concave dose-response pattern (Placebo=2.5 mg\<5.0 mg)|MMRM|||Investigation of dose-response relationship of change from baseline to Day 56 in PANSS Total Score was a Secondary study endpoint. Multiple contrast testing using MMRM model was used to evaluate 3 pre-defined dose-response patterns (Linear, Convex, Concave)||||0.273
70879963|NCT01190254|141245290|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.2||||0.218|TWO_SIDED|95.0|-0.5|0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Confirmative testing for the key secondary endpoint was to be performed only if both asenapine doses were superior to placebo in change from baseline in PANSS total score at Day 56 (hypotheses associated with Primary outcome measure). If this did not occur, no confirmative testing could be performed and multiplicity unadjusted p-values are provided. Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.1|-0.5|0.218
70879964|NCT01190254|141245290|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.3||||0.024||95.0|-0.6|0.0|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Confirmative testing for the key secondary endpoint was to be performed only if both asenapine doses were superior to placebo in change from baseline in PANSS total score at Day 56 (hypotheses associated with Primary outcome measure). If this did not occur, no confirmative testing could be performed and multiplicity unadjusted p-values are provided. Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||-0.0|-0.6|0.024
70879965|NCT01190254|141245291|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.6||||0.067|TWO_SIDED|95.0|-3.3|0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.1|-3.3|0.067
70879966|NCT01190254|141245291|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.1||||0.012|TWO_SIDED|95.0|-3.8|-0.5|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||-0.5|-3.8|0.012
70879967|NCT01190254|141245292|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.2||||0.097|TWO_SIDED|95.0|-2.6|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.2|-2.6|0.097
70879968|NCT01190254|141245292|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.2||||0.099|TWO_SIDED|95.0|-2.6|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.2|-2.6|0.099
70879969|NCT01190254|141245293|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.7||||0.062|TWO_SIDED|95.0|-5.6|0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.1|-5.6|0.062
70879970|NCT01190254|141245293|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-3.2||||0.025|TWO_SIDED|95.0|-6.0|-0.4|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||-0.4|-6.0|0.025
70879971|NCT01190254|141245294|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.1||||0.098|TWO_SIDED|95.0|-4.6|0.4|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.4|-4.6|0.098
70879972|NCT01190254|141245294|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.3||||0.071|TWO_SIDED|95.0|-4.8|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.2|-4.8|0.071
70879973|NCT01190254|141245295|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.4||||0.106|TWO_SIDED|95.0|-3.1|0.3|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.3|-3.1|0.106
70879974|NCT01190254|141245295|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.9||||0.026|TWO_SIDED|95.0|-3.6|-0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||-0.2|-3.6|0.026
70879975|NCT01190254|141245296|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.2||||0.083|TWO_SIDED|95.0|-2.6|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.2|-2.6|0.083
70879976|NCT01190254|141245296|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.3||||0.067|TWO_SIDED|95.0|-2.7|0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.1|-2.7|0.067
70879977|NCT01190254|141245297|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.9||||0.131|TWO_SIDED|95.0|-2.1|0.3|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.3|-2.1|0.131
70879978|NCT01190254|141245297|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.9||||0.135|TWO_SIDED|95.0|-2.1|0.3|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.3|-2.1|0.135
70879979|NCT01190254|141245298|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.0||||0.071|TWO_SIDED|95.0|-2.0|0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.1|-2.0|0.071
70879980|NCT01190254|141245298|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.8||||0.12|TWO_SIDED|95.0|-1.9|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.2|-1.9|0.120
70879981|NCT01190254|141245299|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.4||||0.263|TWO_SIDED|95.0|-1.2|0.3|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.3|-1.2|0.263
70879982|NCT01190254|141245299|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.5||||0.146|TWO_SIDED|95.0|-1.3|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.2|-1.3|0.146
70879983|NCT01190254|141245300|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.0||||0.028|TWO_SIDED|95.0|1.1|3.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of (pooled) site, treatment, and baseline PANSS Total Score|OR was adjusted for baseline and (pooled) site. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total PANSS 30% response|||3.6|1.1|0.028
70879984|NCT01190254|141245300|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.8||||0.048|TWO_SIDED|95.0|1.0|3.3||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of (pooled) site, treatment, and baseline PANSS Total Score|OR was adjusted for baseline and (pooled) site. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total PANSS 30% response|||3.3|1.0|0.048
70879985|NCT01190254|141245301|SUPERIORITY_OR_OTHER_LEGACY|||||||0.576||||||p-value is for Log Rank test of difference in time to event (PANSS 30% response) curves between the three treatment groups|Log Rank|||||||0.576
70879986|NCT01190254|141245301|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3||||0.171|TWO_SIDED|95.0|0.9|2.0|||Regression, Cox|Model included factors for (pooled) site, treatment and baseline PANSS Total Score|An HR of \>1 is considered to mean that asenapine has a higher likelihood of being a Total PANSS 30% Responder than placebo|||2.0|0.9|0.171
70879987|NCT01190254|141245301|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.2||||0.368|TWO_SIDED|95.0|0.8|1.8|||Regression, Cox|Model included factors for (pooled) site, treatment and baseline PANSS Total Score|An HR of \>1 is considered to mean that asenapine has a higher likelihood of being a Total PANSS 30% Responder than placebo|||1.8|0.8|0.368
70879988|NCT01190254|141245302|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.3||||0.094|TWO_SIDED|95.0|-0.6|0.0|||MMRM|Model included terms of (pooled) site, treatment, visit, and the interaction of visit by treatment|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.0|-0.6|0.094
70879989|NCT01190254|141245302|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.5||||0.003|TWO_SIDED|95.0|-0.8|-0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, and the interaction of visit by treatment|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||-0.2|-0.8|0.003
70879990|NCT01190254|141245303|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.5||||0.177|TWO_SIDED|95.0|0.8|2.8||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of region (Asia-Pacific, North America, Eastern Europe \[Africa/Latin America sites assigned to this region\]) and treatment|OR was adjusted for region. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving CGI-I response|||2.8|0.8|0.177
70879991|NCT01190254|141245303|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.6||||0.114|TWO_SIDED|95.0|0.9|2.9||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of region (Asia-Pacific, North America, Eastern Europe \[Africa/Latin America sites assigned to this region\]) and treatment|OR was adjusted for region. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving CGI-I response|||2.9|0.9|0.114
70879992|NCT01190254|141245304|SUPERIORITY_OR_OTHER_LEGACY|||||||0.057||||||p-value is for Log Rank test of difference in time to event (CGI-I response) curves between the three treatment groups|Log Rank|||||||0.057
70879993|NCT01190254|141245304|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.4||||0.135|TWO_SIDED|95.0|0.9|2.3|||Regression, Cox|Model included factors for (pooled) site and treatment|An HR of \>1 is considered to mean that asenapine has a higher likelihood of being a CGI-I Responder than placebo|||2.3|0.9|0.135
70879994|NCT01190254|141245304|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.8||||0.01|TWO_SIDED|95.0|1.2|2.9|||Regression, Cox|Model included factors for (pooled) site and treatment|An HR of \>1 is considered to mean that asenapine has a higher likelihood of being a CGI-I Responder than placebo|||2.9|1.2|0.010
70879995|NCT01190254|141245305|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|1.4||||0.417|TWO_SIDED|95.0|-2.0|4.8|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||4.8|-2.0|0.417
70879996|NCT01190254|141245305|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|4.2||||0.017|TWO_SIDED|95.0|0.8|7.6|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||7.6|0.8|0.017
70879997|NCT01190254|141245306|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.6||||0.6|TWO_SIDED|95.0|-1.6|2.8|||ANCOVA|Model included terms of (pooled) site, treatment, and baseline|Estimate is asenapine versus placebo|||2.8|-1.6|0.600
70879998|NCT01190254|141245306|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|2.1||||0.064|TWO_SIDED|95.0|-0.1|4.3|||ANCOVA|Model included terms of (pooled) site, treatment, and baseline|Estimate is asenapine versus placebo|||4.3|-0.1|0.064
70879999|NCT01190254|141245307|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.1||||0.407|TWO_SIDED|95.0|-0.13|0.33|||ANCOVA|Model included terms of (pooled) site, treatment, and baseline|Estimate is asenapine versus placebo|||0.33|-0.13|0.407
70880000|NCT01190254|141245307|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.19||||0.111|TWO_SIDED|95.0|-0.04|0.42|||ANCOVA|Model included terms of (pooled) site, treatment, and baseline|Estimate is asenapine versus placebo|||0.42|-0.04|0.111
70880001|NCT02603809|141245308|OTHER||||||<|0.001|||||||Multiple Comparison Procedure-Modeling|||"Multiple Comparison Procedure-Modeling (MCP-Mod) was used to assess a dose-response across placebo and all aprocitentan doses. The null hypothesis of no dose-response was rejected if at least one of the six Multiple Contrast Tests (MCTs) had a multiplicity adjusted p-value \<0.05. The analysis was performed using the R-package DoseFinding (Bornkamp B, Pinheiro J, Bretz F. Planning and analyzing dose finding experiments. 2016. Available from: cran.r-projects.org/web/packages/DoseFinding.)"||||<0.001
70880002|NCT02603809|141245308|SUPERIORITY||LS Mean|-1.31|STANDARD_ERROR_OF_MEAN|1.548||0.8117|TWO_SIDED|95.0|-5.1|2.49|||ANCOVA|with Dunnett correction.||||2.49|-5.10|0.8117
70880003|NCT02603809|141245308|SUPERIORITY||LS Mean|-4.93|STANDARD_ERROR_OF_MEAN|1.532||0.0053|TWO_SIDED|95.0|-8.68|-1.17|||ANCOVA|with Dunnett correction.||||-1.17|-8.68|0.0053
70880004|NCT02603809|141245308|SUPERIORITY||LS Mean|-6.99|STANDARD_ERROR_OF_MEAN|1.554|<|0.0001|TWO_SIDED|95.0|-10.8|-3.19|||ANCOVA|with Dunnett correction.||||-3.19|-10.80|<.0001
70880005|NCT02603809|141245308|SUPERIORITY||LS Mean|-4.95|STANDARD_ERROR_OF_MEAN|1.549||0.0057|TWO_SIDED|95.0|-8.75|-1.15|||ANCOVA|with Dunnett correction.||||-1.15|-8.75|0.0057
70880006|NCT02603809|141245309|OTHER||||||<|0.001|||||||Multiple Comparison Procedure-Modeling|||"Multiple Comparison Procedure-Modeling (MCP-Mod) was used to assess a dose-response across placebo and all aprocitentan doses. The null hypothesis of no dose-response was rejected if at least one of the six Multiple Contrasts Tests (MCTs) had a multiplicity adjusted p-value \<0.05. The analysis was performed using the R-package DoseFinding (Bornkamp B, Pinheiro J, Bretz F. Planning and analyzing dose finding experiments. 2016. Available from: cran-rprojects.org/web/packages/DoseFinding.)"||||<0.001
70880007|NCT02603809|141245309|SUPERIORITY||LS Mean|-2.45|STANDARD_ERROR_OF_MEAN|2.445||0.7071|TWO_SIDED|95.0|-8.44|3.54|||ANCOVA|with Dunnett correction.||||3.54|-8.44|0.7071
70880008|NCT02603809|141245309|SUPERIORITY||LS Mean|-7.05|STANDARD_ERROR_OF_MEAN|2.42||0.0138|TWO_SIDED|95.0|-12.98|-1.12|||ANCOVA|with Dunnett correction.||||-1.12|-12.98|0.0138
70880009|NCT02603809|141245309|SUPERIORITY||LS Mean|-9.9|STANDARD_ERROR_OF_MEAN|2.457||0.0003|TWO_SIDED|95.0|-15.92|-3.88|||ANCOVA|with Dunnett correction.||||-3.88|-15.92|0.0003
70880010|NCT02603809|141245309|SUPERIORITY||LS Mean|-7.58|STANDARD_ERROR_OF_MEAN|0.0077||0.0077|TWO_SIDED|95.0|-13.58|-1.59|||ANCOVA|with Dunnett correction.||||-1.59|-13.58|0.0077
70959730|NCT01037244|141423612|SUPERIORITY_OR_OTHER||Difference in LS Means|2.56|||<|0.0001|TWO_SIDED|95.0|2.03|3.09|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||3.09|2.03|<0.0001
70959731|NCT01037244|141423613|SUPERIORITY_OR_OTHER||Difference in LS Means|12.34|||<|0.0001|TWO_SIDED|95.0|7.29|17.4|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||17.40|7.29|<0.0001
70959732|NCT01037244|141423613|SUPERIORITY_OR_OTHER||Difference in LS Means|19.29|||<|0.0001|TWO_SIDED|95.0|14.23|24.36|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||24.36|14.23|<0.0001
70959733|NCT01037244|141423613|SUPERIORITY_OR_OTHER||Difference in LS Means|19.16|||<|0.0001|TWO_SIDED|95.0|14.14|24.18|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled sites as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||24.18|14.14|<0.0001
70959734|NCT01037244|141423614|SUPERIORITY_OR_OTHER||Difference in LS Means|18.07|||<|0.0001|TWO_SIDED|95.0|10.7|25.43|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||25.43|10.70|<0.0001
70959735|NCT01037244|141423614|SUPERIORITY_OR_OTHER||Difference in LS Means|23.53|||<|0.0001|TWO_SIDED|95.0|16.12|30.94|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||30.94|16.12|<0.0001
70959736|NCT01037244|141423614|SUPERIORITY_OR_OTHER||Difference in LS Means|36.25|||<|0.0001|TWO_SIDED|95.0|28.92|43.59|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||43.59|28.92|<0.0001
70959737|NCT01037244|141423615|SUPERIORITY_OR_OTHER||Difference in LS Means|18.2|||<|0.0001|TWO_SIDED|95.0|10.79|25.6|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||25.60|10.79|<0.0001
70880011|NCT02603809|141245315|OTHER||||||<|0.001|||||||Multiple Comparison Procedure-Modeling|||"Multiple Comparison Procedure-Modeling (MCP-Mod) was used to assess a dose-response across placebo and all aprocitentan doses. The null hypothesis of no dose-response was rejected if at least one of the six Multiple Contrast Tests (MCTs) had a multiplicity adjusted p-value \<0.05. The analysis was performed using the R-package DoseFinding (Bornkamp B, Pinheiro J, Bretz F. Planning and analyzing dose finding experiments. 2016. Available from: cran.r-projects.org/web/packages/DoseFinding.)"||||<0.001
70959738|NCT01037244|141423615|SUPERIORITY_OR_OTHER||Difference in LS Means|25.25|||<|0.0001|TWO_SIDED|95.0|17.82|32.69|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||32.69|17.82|<0.0001
70959739|NCT01037244|141423615|SUPERIORITY_OR_OTHER||Difference in LS Means|36.99|||<|0.0001|TWO_SIDED|95.0|29.63|44.36|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||44.36|29.63|<0.0001
70959740|NCT01037244|141423616|SUPERIORITY_OR_OTHER||Difference in LS Means|19.98|||<|0.0001|TWO_SIDED|95.0|12.69|27.26|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||27.26|12.69|<0.0001
70959741|NCT01037244|141423616|SUPERIORITY_OR_OTHER||Difference in LS Means|27.58|||<|0.0001|TWO_SIDED|95.0|20.29|34.88|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||34.88|20.29|<0.0001
70959742|NCT01037244|141423616|SUPERIORITY_OR_OTHER||Difference in LS Means|37.8|||<|0.0001|TWO_SIDED|95.0|30.57|45.03|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||45.03|30.57|<0.0001
70959743|NCT00690820|141423617|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
70959744|NCT00690820|141423618|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
70959745|NCT00690820|141423619|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
70880012|NCT02603809|141245315|SUPERIORITY||LS Mean|-1.75|STANDARD_ERROR_OF_MEAN|1.401||0.5356|TWO_SIDED|95.0|-5.19|1.69|||ANCOVA|with Dunnett correction.||||1.69|-5.19|0.5356
70959746|NCT00690820|141423620|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
70880013|NCT02603809|141245315|SUPERIORITY||LS Mean|-5.82|STANDARD_ERROR_OF_MEAN|1.396||0.0001|TWO_SIDED|95.0|-9.25|-2.4|||ANCOVA|with Dunnett correction.||||-2.40|-9.25|0.0001
70880014|NCT02603809|141245315|SUPERIORITY||LS Mean|-7.5|STANDARD_ERROR_OF_MEAN|1.41|<|0.0001|TWO_SIDED|95.0|-10.96|-4.04|||ANCOVA|with Dunnett correction.||||-4.04|-10.96|<.0001
70880015|NCT02603809|141245315|SUPERIORITY||LS Mean|-5.65|STANDARD_ERROR_OF_MEAN|1.41||0.0003|TWO_SIDED|95.0|-9.11|-2.19|||ANCOVA|with Dunnett correction.||||-2.19|-9.11|0.0003
70880016|NCT00887354|141245318|SUPERIORITY_OR_OTHER_LEGACY||LS Mean|0.04|||<|0.0001|TWO_SIDED|95.0|0.025|0.055|||Mixed Models Analysis|||||0.055|0.025|<.0001
70880017|NCT03265249|141245325|SUPERIORITY||Median Difference (Final Values)|5.7||||0.8|TWO_SIDED|95.0|-17.5|29.0|||Mixed Models Analysis|||||29|-17.5|0.80
70880018|NCT00914810|141245333|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.55|TWO_SIDED|95.0|-0.8|1.5|||t-test, 2 sided|||||1.5|-0.8|0.55
70880019|NCT00914810|141245334|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.5|||<|0.0001|TWO_SIDED|95.0|7.4|13.6|||t-test, 2 sided|||||13.6|7.4|<0.0001
70959747|NCT00690820|141423621|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
70880020|NCT02063516|141245357|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|95.0|||||t-test, 2 sided|||It was calculated that 80 adult patients randomized from different surgical department would have 80% power to detect a difference in 2 point in mean. Sampling size was determined using 2 sided t-test (alpha=0.05).||||0.04
70880021|NCT02063516|141245358|SUPERIORITY_OR_OTHER|||||||0.836|TWO_SIDED|95.0|||||Chi-squared|||||||0.836
70880022|NCT02063516|141245359|SUPERIORITY_OR_OTHER|||||||0.0035|TWO_SIDED||||||t-test, 2 sided|||Amount of air added at 30 minutes to maintain cuff pressure 60cmH2O||||0.0035
70880023|NCT02063516|141245359|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|||Amount of air added at 60 minutes to maintain cuff pressure 60cmH2O||||0.003
70880024|NCT02063516|141245359|SUPERIORITY_OR_OTHER|||||||0.0042|TWO_SIDED||||||t-test, 2 sided|||Amount of air added at 90 minutes to maintain cuff pressure 60cmH2O||||0.0042
70880025|NCT02063516|141245359|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||Amount of air added at 120 minutes to maintain cuff pressure 60cmH2O||||0.004
70880026|NCT02449174|141245386|SUPERIORITY|||||||0.8958|||||||Chi-squared, Corrected|||||||0.8958
70880027|NCT02449174|141245387|SUPERIORITY|||||||0.2059|||||||Chi-squared, Corrected|||||||0.2059
70880028|NCT02188589|141245392|EQUIVALENCE|The difference between the mean baseline and mean follow-up NOSE scores was evaluated by paired t-test with significance indicated by p\<0.05.|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70880029|NCT00867451|141245394|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||||||<.05
70959748|NCT00690820|141423622|SUPERIORITY_OR_OTHER|||||||0.671||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||0.671
70959749|NCT00690820|141423623|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||0.003
70959750|NCT00690820|141423624|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||0.023
70959751|NCT01249274|141423636|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.19||||0.01|TWO_SIDED|95.0|1.04|1.36|||Generalized Estimating Equation|Negative binomial distribution, log link, and first-order autoregressive covariance structure|Estimated value is the risk ratio estimate for the treatment x time interaction term. Time was treated as a continuous variable and progesterone was the reference group for the treatment variable.|||1.36|1.04|0.010
70959752|NCT01249274|141423637|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|30.39||||0.003|TWO_SIDED|95.0|3.18|290.04|||Generalized Estimating Equation|Negative binomial distribution, log link, and first-order autoregressive covariance structure|Estimated value is RR for treatment\*time interaction for placebo at 3-mo post-trial follow-up. Time treated as a 3-level categorical variable; week 0 (ref), week 12 \& 3-month post-trial follow-up. Treatment variable reference group was progesterone.|We calculated that a sample size of 50 women would have 80% power to detect a significant (p\<0.05) difference between groups if the effect size for the primary outcome was large.||290.04|3.18|0.003
70959753|NCT01249274|141423637|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|16.65||||0.038|TWO_SIDED|95.0|1.18|235.52|||Generalized Estimating Equation||Estimated value is RR for treatment\*time interaction term for placebo at week 12. Time was treated as a 3-level categorical variable; week 0 (ref), week 12 and 3-month post-trial follow-up. Treatment variable reference group was progesterone.|Negative binomial distribution, log link, and first-order autoregressive covariance structure||235.52|1.18|0.038
70959754|NCT01249274|141423638|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.99|TWO_SIDED|95.0|0.87|1.15|||Generalized Estimating Equation||Estimated value is the risk ratio for the treatment x time interaction term. Time was treated as a continuous variable and progesterone was the reference group for treatment.|We calculated that a sample size of 50 women would have 80% power to detect a significant (p\<0.05) difference between groups if the effect size for the primary outcome was large.||1.15|0.87|0.99
70959755|NCT01249274|141423639|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.34||||0.75|TWO_SIDED|95.0|0.23|7.88|||Generalized Estimating Equation||Estimated value is RR for treatment\*time interaction for placebo at 3-mo post-trial follow-up. Time treated as a 3-level categorical variable; week 0 (ref), week 12 \& 3-month post-trial follow-up. Treatment variable reference group was progesterone.|We calculated that a sample size of 50 women would have 80% power to detect a significant (p\<0.05) difference between groups if the effect size for the primary outcome was large.||7.88|0.23|0.75
70959756|NCT01249274|141423639|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.18||||0.84|TWO_SIDED|95.0|0.24|5.84|||Generalized Estimating Equation|Negative binomial distribution, log link, and first-order autoregressive covariance structure|Estimated value is RR for treatment\*time interaction for placebo at week 12. Time was treated as a 3-level categorical variable; week 0 (ref), week 12 \& 3-month post-trial follow-up. Treatment variable reference group was progesterone.|||5.84|0.24|0.84
70959757|NCT01249274|141423640|SUPERIORITY_OR_OTHER|||||||0.103|TWO_SIDED||||||Fisher Exact|||||||0.1030
70959758|NCT01249274|141423641|SUPERIORITY_OR_OTHER||Score Statistic For Type 3 GEE Analysis|0.01||||0.9116|TWO_SIDED||||||Generalized Estimating Equation|Gamma distribution, logit link, 1st-order autoregressive covariance structure; p-value is for chi-sq (df=1) for type 3 GEE analysis score statistic|Estimated value is chi-sq (df=1) for type 3 GEE analysis score statistic for week\*treatment interaction term.|||||0.9116
70959759|NCT01249274|141423644|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|4.71||||0.048|TWO_SIDED|95.0|1.09|20.5|||Regression, Cox||Ratio presented is for placebo versus progesterone|||20.50|1.09|0.048
70959760|NCT01249274|141423645|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|3.5||||0.06|TWO_SIDED|95.0|0.92|13.3|||Regression, Cox||Ratio presented is for placebo versus progesterone|||13.30|0.92|0.06
70959761|NCT01708213|141423687|SUPERIORITY_OR_OTHER||Parametric Testing|0.05|||<|0.05|TWO_SIDED||||||Parametric testing|||||||<0.05
70959762|NCT04964414|141423705|SUPERIORITY|||||||0.6|||||||Paired t-test|||||||0.6
70959763|NCT04964414|141423706|SUPERIORITY|||||||0.6|||||||Wilcoxon signed-rank|||||||0.6
70959764|NCT04964414|141423707|SUPERIORITY|||||||0.09|||||||Paired t-test|||||||0.09
70959765|NCT04964414|141423712|SUPERIORITY|||||||0.2|||||||Paired t-test|||||||0.2
70959766|NCT04964414|141423713|SUPERIORITY|||||||0.2|||||||Paired t-test|||||||0.2
70959767|NCT00679627|141423764|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
70959768|NCT00679627|141423765|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.011|TWO_SIDED|95.0|0.37|0.89|||Regression, Cox|||||0.89|0.37|0.011
70959769|NCT00679627|141423766|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
70959770|NCT00679627|141423767|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANCOVA|||||||0.002
70959771|NCT00679627|141423770|SUPERIORITY_OR_OTHER|||||||0.269||||||Baseline|Cochran-Mantel-Haenszel|||||||0.269
70959772|NCT00679627|141423770|SUPERIORITY_OR_OTHER|||||||0.835||||||Month 24|Cochran-Mantel-Haenszel|||||||0.835
70959773|NCT00679627|141423771|SUPERIORITY_OR_OTHER|||||||0.194||||||Orientation subscale|ANCOVA|||||||0.194
70959774|NCT00679627|141423771|SUPERIORITY_OR_OTHER|||||||0.353||||||Registration subscale|ANCOVA|||||||0.353
70959775|NCT00679627|141423771|SUPERIORITY_OR_OTHER|||||||0.009||||||Attention and Calculation subscale|ANCOVA|||||||0.009
70959776|NCT00679627|141423771|SUPERIORITY_OR_OTHER|||||||0.158||||||Recall subscale|ANCOVA|||||||0.158
70959777|NCT00679627|141423771|SUPERIORITY_OR_OTHER|||||||0.088||||||Language subscale|ANCOVA|||||||0.088
70959778|NCT00679627|141423772|SUPERIORITY_OR_OTHER|||||||0.01||||||Initiation subscale|ANCOVA|||||||0.010
70959779|NCT00679627|141423772|SUPERIORITY_OR_OTHER|||||||0.043||||||Planning and Organization subscale|ANCOVA|||||||0.043
70959780|NCT00679627|141423772|SUPERIORITY_OR_OTHER|||||||0.018||||||Effective Performance subscale|ANCOVA|||||||0.018
70959781|NCT00679627|141423772|SUPERIORITY_OR_OTHER|||||||0.005||||||Basic subscale|ANCOVA|||||||0.005
70959782|NCT00679627|141423772|SUPERIORITY_OR_OTHER|||||||0.054||||||Instrumental subscale|ANCOVA|||||||0.054
70959783|NCT00679627|141423772|SUPERIORITY_OR_OTHER|||||||0.137||||||Leisure subscale|ANCOVA|||||||0.137
70959784|NCT01886378|141423773|SUPERIORITY||Least squares (LS) mean|423.594||||0.1518|TWO_SIDED|95.0|-155.66|1002.85||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% confidence interval (CI), and p-values are based on the GEE model.|||1002.85|-155.66|0.1518
70959785|NCT01886378|141423774|SUPERIORITY||LS mean|-0.011||||0.3964|TWO_SIDED|95.0|-0.04|0.01||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% CI, and p-values are based on the GEE model.|||0.01|-0.04|0.3964
70959786|NCT01886378|141423775|SUPERIORITY||LS mean|4.671||||0.0777|TWO_SIDED|95.0|-0.52|9.86||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% CI, and p-values are based on the GEE model.|||9.86|-0.52|0.0777
70959787|NCT01886378|141423776|SUPERIORITY||LS mean|181.37||||0.083|TWO_SIDED|95.0|-23.7|386.45||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% CI, and p-values are based on the GEE model.|||386.45|-23.70|0.0830
70959788|NCT01886378|141423777|SUPERIORITY||LS mean|-0.185||||0.032|TWO_SIDED|95.0|-0.35|-0.02||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% CI, and p-values are based on the GEE model.|||-0.02|-0.35|0.0320
70959789|NCT01886378|141423778|SUPERIORITY||LS mean|12.44||||0.085|TWO_SIDED|95.0|-1.72|26.6||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% CI, and p-values are based on the GEE model.|||26.60|-1.72|0.0850
70959790|NCT01886378|141423779|SUPERIORITY||LS mean|2.16||||0.3754|TWO_SIDED|95.0|-2.62|6.94||The LS Mean, standard error (SE), 95% CI, and 2-sided p-value are from the GEE model.|GEE model|||||6.94|-2.62|0.3754
70959791|NCT01886378|141423780|SUPERIORITY||LS mean|0.816||||0.7564|TWO_SIDED|95.0|-4.34|5.97||The LS Mean, SE, 95% CI, and 2-sided p-value are from the GEE model.|GEE model|||||5.97|-4.34|0.7564
70959792|NCT01886378|141423781|SUPERIORITY||LS mean|8.88|||<|0.0001|TWO_SIDED|95.0|5.67|12.08||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model|||||12.08|5.67|<0.0001
70959793|NCT01886378|141423782|SUPERIORITY||LS mean|9.7||||0.0152|TWO_SIDED|95.0|1.87|17.54||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% CI, and p-values are based on the GEE model.|||17.54|1.87|0.0152
70959794|NCT02656160|141423800|OTHER|||||||0.85||||||P\<0.05 considered statistically significant|Wilcoxon (Mann-Whitney)|||tonic||||0.85
70959795|NCT02656160|141423800|OTHER|||||||0.322||||||P\<0.05 considered statistically significant|Wilcoxon (Mann-Whitney)|||Phasic activity||||0.322
70959796|NCT02656160|141423801|OTHER|||||||0.42||||||P\<0.05 considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.42
70959797|NCT00446992|141423805|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||<0.001
70959798|NCT00446992|141423806|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||.043
70959799|NCT00446992|141423807|SUPERIORITY_OR_OTHER||||||=|0.69|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||= 0.690
70959800|NCT00446992|141423808|SUPERIORITY_OR_OTHER||||||=|0.691|TWO_SIDED||||||Intervariate|||Baseline compared to Week 16||||= 0.691
70959801|NCT00446992|141423809|SUPERIORITY_OR_OTHER||||||=|0.877|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||= 0.877
70959802|NCT00446992|141423810|SUPERIORITY_OR_OTHER||||||=|0.003|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||= 0.003
70959803|NCT00446992|141423811|SUPERIORITY_OR_OTHER||||||=|0.005|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||= .005
70959804|NCT00446992|141423812|SUPERIORITY_OR_OTHER||||||=|0.696|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||= 0.696
70959805|NCT00446992|141423813|SUPERIORITY_OR_OTHER||||||=|0.013|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||= 0.013
70959806|NCT01275131|141423814|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|13.95||||0.0009|TWO_SIDED|90.0|7.37|20.54|||Mixed Models Analysis|A mixed model with fixed effects for treatment, day, and interaction of treatment with day was performed using a compound symmetric covariance matrix.||Comparison at Stage 1, Day 2/6||20.54|7.37|0.0009
70959807|NCT01275131|141423814|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|18.14|||<|0.0001|TWO_SIDED|90.0|11.55|24.72|||Mixed Models Analysis|A mixed model with fixed effects for treatment, day, and interaction of treatment with day was performed using a compound symmetric covariance matrix.||Comparison at Stage 1, Day 4/8||24.72|11.55|<0.0001
70880030|NCT00975481|141245402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.8096|||<|0.0001|TWO_SIDED|95.0|15.0866|26.5327|||Mixed Models Analysis|Mixed-effect model was implemented with Restricted Maximum Likelihood (REML) estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95 percent (%) Confidence Interval (CI) were obtained from the model.||26.5327|15.0866|<0.0001
70880031|NCT00975481|141245402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.4625|||<|0.0001|TWO_SIDED|95.0|18.7321|30.1929|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||30.1929|18.7321|<0.0001
70880032|NCT00975481|141245402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5792||||0.8428|TWO_SIDED|95.0|-6.3385|5.18|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.1800|-6.3385|0.8428
70880033|NCT00975481|141245402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9993||||0.4957|TWO_SIDED|95.0|-7.7832|3.7845|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.7845|-7.7832|0.4957
70880034|NCT00975481|141245402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9683||||0.7431|TWO_SIDED|95.0|-4.8567|6.7932|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.7932|-4.8567|0.7431
70880035|NCT00975481|141245402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.3889|||<|0.0001|TWO_SIDED|95.0|-27.1044|-15.6734|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-15.6734|-27.1044|<0.0001
70880036|NCT00975481|141245402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.809|||<|0.0001|TWO_SIDED|95.0|-28.5584|-17.0596|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-17.0596|-28.5584|<0.0001
70880037|NCT00975481|141245402|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-19.8414|||<|0.0001|TWO_SIDED|95.0|-25.6435|-14.0393|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-14.0393|-25.6435|<0.0001
70959808|NCT01275131|141423816|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|16.41|||<|0.0001|TWO_SIDED|90.0|11.86|20.97|||Mixed Models Analysis|Mixed model with fixed effects for treatment, day, and interaction of treatment with day. A compound symmetric covariance matrix was assumed.||Comparison at Stage 3, Day 2/7||20.97|11.86|<0.0001
70959809|NCT01275131|141423816|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|14.1|||<|0.0001|TWO_SIDED|90.0|9.55|18.65|||Mixed Models Analysis|Mixed model with fixed effects for treatment, day, and interaction of treatment with day. A compound symmetric covariance matrix was assumed.||Comparison at Stage 3, Day 3/8||18.65|9.55|<0.0001
70880038|NCT00975481|141245402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.0418|||<|0.0001|TWO_SIDED|95.0|-30.6705|-19.413|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-19.4130|-30.6705|<0.0001
70880039|NCT00975481|141245402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.4618|||<|0.0001|TWO_SIDED|95.0|-32.1455|-20.7782|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-20.7782|-32.1455|<0.0001
70880040|NCT00975481|141245402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.4943|||<|0.0001|TWO_SIDED|95.0|-29.244|-17.7445|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-17.7445|-29.2440|<0.0001
70880041|NCT00975481|141245402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4538||||0.572|TWO_SIDED|95.0|-6.5274|3.6198|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.6198|-6.5274|0.5720
70880042|NCT00975481|141245402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.9938||||0.0006|TWO_SIDED|95.0|-14.0695|-3.918|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.9180|-14.0695|0.0006
70880043|NCT00975481|141245402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8686||||0.4704|TWO_SIDED|95.0|-3.2342|6.9713|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.9713|-3.2342|0.4704
70880044|NCT00975481|141245402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0725||||0.4255|TWO_SIDED|95.0|-3.0533|7.1984|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||7.1984|-3.0533|0.4255
70880045|NCT00975481|141245402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3425||||0.8959|TWO_SIDED|95.0|-5.5053|4.8204|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.8204|-5.5053|0.8959
70880046|NCT00975481|141245402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3224||||0.1967|TWO_SIDED|95.0|-1.7402|8.385|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.3850|-1.7402|0.1967
70880047|NCT00975481|141245402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5264||||0.1733|TWO_SIDED|95.0|-1.5676|8.6203|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.6203|-1.5676|0.1733
70959810|NCT01275131|141423816|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.32||||0.0552|TWO_SIDED|90.0|0.77|9.88|||Mixed Models Analysis|Mixed model with fixed effects for treatment, day, and interaction of treatment with day. A compound symmetric covariance matrix was assumed.||Comparison at Stage 3, Day 5/10||9.88|0.77|0.0552
70959811|NCT02076178|141423828|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Fisher Exact|||Any Grade 2 or higher event, any Grade 2 or higher event Vs Cabotegravir||||<0.01
70959812|NCT02434939|141423886|NON_INFERIORITY_OR_EQUIVALENCE|a clinically significant difference in validated pain scores was defined as 1.3. assuming both treatments are on average equal, 240 patients provided 95% power to demonstrate that IV low dose ketamine is non inferior to IV morphine with a 0.05 level of significance.|Mean Difference (Final Values)|5.5||||0.18|TWO_SIDED|95.0|-2.2|13.2|||t-test, 2 sided|||||13.2|-2.2|0.18
70959813|NCT02434939|141423889|NON_INFERIORITY_OR_EQUIVALENCE|A clinically meaningful difference in validated pain scores was defined as 1.3.Assuming both treatments are on average equal, a sample size of 240 patients (120 per group) provided 95% power to demonstrate that IV LDK is non-inferior to IV morphine with a 0.05 level of significance.||||||0.07|||||||t-test, 2 sided|||||||0.07
70959814|NCT03430206|141423890|OTHER|||||||0.206|||||||Regression, Negative Binomial|||||||0.206
70959815|NCT03430206|141423891|OTHER|||||||0.101|||||||Regression, Negative Binomial|||||||0.101
70959816|NCT03430206|141423892|OTHER|||||||0.371|||||||Regression, Negative Binomial|||||||0.371
70959817|NCT03430206|141423894|OTHER|||||||0.601|||||||Regression, Negative Binomial|||||||0.601
70959818|NCT03430206|141423895|OTHER|||||||0.738|||||||Regression, Negative Binomial|||||||0.738
70959819|NCT01992393|141423936|OTHER|||||||0.036|||||||GEE|||||||0.036
70959820|NCT01992393|141423937|OTHER|||||||0.042|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.042
70959821|NCT01992393|141423937|OTHER|||||||0.204|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU||||0.204
70959822|NCT01992393|141423938|OTHER|||||||0.129|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.129
70959823|NCT01992393|141423938|OTHER|||||||0.978|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.||||0.978
70959824|NCT01992393|141423939|OTHER|||||||0.128|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.128
70959825|NCT01992393|141423939|OTHER|||||||0.015|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.||||0.015
70959826|NCT01992393|141423940|OTHER|||||||0.759|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.759
70959827|NCT01992393|141423940|OTHER|||||||0.471|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.||||0.471
70959828|NCT01992393|141423941|OTHER|||||||0.775|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.775
70959829|NCT01992393|141423941|OTHER|||||||0.433|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.||||0.433
70959830|NCT01992393|141423942|OTHER|||||||0.936|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.936
70959831|NCT01992393|141423942|OTHER|||||||0.6|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.||||0.600
70959832|NCT01992393|141423943|OTHER|||||||0.56|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.560
70959833|NCT01992393|141423943|OTHER|||||||0.305|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.305
70959834|NCT00585195|141423973|SUPERIORITY||Ratio of adjusted geometric means|131.72|||||TWO_SIDED|90.0|96.59|179.63||||||||179.63|96.59|
70959835|NCT00585195|141423973|SUPERIORITY||Ratio of adjusted geometric means|239.03|||||TWO_SIDED|90.0|172.14|331.93||||||||331.93|172.14|
70959836|NCT00585195|141423973|SUPERIORITY||Ratio of adjusted geometric means|201.56|||||TWO_SIDED|90.0|139.33|291.58||||||||291.58|139.33|
70959837|NCT00585195|141423974|SUPERIORITY||Ratio of adjusted geometric means|216.19|||||TWO_SIDED|90.0|161.41|289.56||||||||289.56|161.41|
70959838|NCT00585195|141423974|SUPERIORITY||Ratio of adjusted geometric means|350.0|||||TWO_SIDED|90.0|141.09|868.23||||||||868.23|141.09|
70959839|NCT00585195|141423974|SUPERIORITY||Ratio of adjusted geometric means|365.43|||||TWO_SIDED|90.0|263.22|507.31||||||||507.31|263.22|
70959840|NCT00585195|141423977|SUPERIORITY||Ratio of adjusted geometric mean|15.57|||||TWO_SIDED|90.0|10.89|22.26||||||||22.26|10.89|
70959841|NCT00585195|141423978|SUPERIORITY||Ratio of adjusted geometric mean|20.64|||||TWO_SIDED|90.0|14.59|29.18||||||||29.18|14.59|
70959842|NCT00585195|141423980|SUPERIORITY||Ratio of adjusted geometric means|157.4|||||TWO_SIDED|90.0|136.89|180.97||||||||180.97|136.89|
70959843|NCT00585195|141423981|SUPERIORITY||Ratio of adjusted geometric means|132.81|||||TWO_SIDED|90.0|119.1|148.1||||||||148.10|119.10|
70959844|NCT02881957|141424024|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||Two-sided t-test evaluated comparing length of stay in vitamin D3 vs. placebo treated patients utilizing patients as randomized (e.g., intent-to-treat) using a p\<0.05 as significant. Adverse events were monitored until discharge.||||0.2
70959845|NCT02881957|141424025|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||0.4
70959846|NCT02881957|141424026|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.3
70959847|NCT02881957|141424027|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.6
70959848|NCT02881957|141424028|SUPERIORITY|||||||0.7|||||||Chi-squared|||||||0.7
70959849|NCT02881957|141424029|SUPERIORITY|||||||0.99|||||||Chi-squared|||Adverse events were monitored until patient discharge from the hospital.||||0.99
70959850|NCT02881957|141424030|SUPERIORITY|||||||0.6|||||||Chi-squared|||Adverse events were monitored until patient discharge from the hospital.||||0.6
70959851|NCT02881957|141424031|SUPERIORITY|||||||0.7|||||||Chi-squared|||Adverse events were monitored until patient discharge from the hospital.||||0.7
70959852|NCT02881957|141424032|SUPERIORITY|||||||0.4|||||||Chi-squared|||Adverse events were monitored until patient discharge from the hospital.||||0.4
70959853|NCT02881957|141424033|SUPERIORITY|||||||0.1|||||||Chi-squared|||Adverse events were monitored until patient discharge from the hospital.||||0.1
70959854|NCT01440374|141424046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.202||||0.0315|TWO_SIDED|95.0|0.047|0.868|||Generalized Linear Mixed Models|||||0.868|0.047|0.0315
70880048|NCT00975481|141245402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1113||||0.6697|TWO_SIDED|95.0|-4.0285|6.2512|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.2512|-4.0285|0.6697
70880049|NCT00975481|141245402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.8623|||<|0.0001|TWO_SIDED|95.0|5.8712|15.8535|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||15.8535|5.8712|<0.0001
70959855|NCT00231153|141424068|SUPERIORITY_OR_OTHER||Net percentage difference|2.25||||0.082||95.0|-0.3|4.81||The primary null hypothesis was tested using the CMH chi-square test stratified region: North America or Europe. Alpha for this test will be 0.05, tow-tailed. No adjustment for multiplicity was performed.|Cochran-Mantel-Haenszel|||Adequate power was provided to test the null hypothesis that there would be no difference between treatment groups for LCSI. Overall LCSI rate was assumed to be approx. 7.5%, with reduction of LCSI by 40% with omiganan. LCSI rates in placebo and omiganan groups would be 9.375% and 5.625%. Sample size of 1548 in MITT set would provide 80% power to detect this difference between treatments. Sample size was also increased by 19% to account for deaths, for total of 1850 planned patients.||4.81|-0.30|0.082
70959856|NCT00231153|141424069|SUPERIORITY_OR_OTHER||Net percentage difference|3.67||||0.002||95.0|1.4|5.93|||Cochran-Mantel-Haenszel|||||5.93|1.40|0.002
70880050|NCT00975481|141245402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0663|||<|0.0001|TWO_SIDED|95.0|6.0281|16.1045|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||16.1045|6.0281|<0.0001
70959857|NCT00231153|141424070|SUPERIORITY_OR_OTHER||Net percentage difference|11.4|||<|0.001||95.0|6.7|16.11|||Cochran-Mantel-Haenszel|||||16.11|6.70|<0.001
70959858|NCT04487834|141424071|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
70959859|NCT04487834|141424072|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||||||0.0001
70959860|NCT04487834|141424073|SUPERIORITY|||||||0.4852|||||||Fisher Exact|||||||0.4852
70959861|NCT04234425|141424075|OTHER|paired t test|Mean Difference (Final Values)|2.702|STANDARD_DEVIATION|5.36||0.017|TWO_SIDED||||||t-test, 2 sided|||||||.017
70959862|NCT04234425|141424076|OTHER|paired t test|Mean Difference (Final Values)|4.2|STANDARD_DEVIATION|7.06||0.08|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.08
70959863|NCT04234425|141424077|OTHER|paired t test|Mean Difference (Final Values)|20.47|STANDARD_DEVIATION|7.33||0.026|TWO_SIDED||||||t-test, 2 sided|||||||.026
70959864|NCT04281004|141424079|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
70959865|NCT04281004|141424080|SUPERIORITY|||||||0.869|||||||Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.869
70959866|NCT04281004|141424081|SUPERIORITY|||||||0.007||||||Significance of treatment effect at month 1.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.007
70959867|NCT04281004|141424081|SUPERIORITY|||||||0.953||||||Significance of treatment effect at month 3.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.953
70959868|NCT04281004|141424081|SUPERIORITY|||||||0.841||||||Significance of treatment effect at month 6.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.841
70959869|NCT04281004|141424081|SUPERIORITY|||||||0.137||||||Significance of treatment effect at month 12.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.137
70959870|NCT04281004|141424082|SUPERIORITY|||||||0.614|||||||t-test, 2 sided|||||||0.614
70959871|NCT04281004|141424083|SUPERIORITY|||||||0.594|||||||Fisher Exact|||||||0.594
70959872|NCT04281004|141424084|SUPERIORITY|||||||0.663||||||Significance of treatment effect at month 1.|Wilcoxon (Mann-Whitney)|Clustered version of the Wilcoxon test||||||0.663
70959873|NCT04281004|141424084|SUPERIORITY|||||||0.416||||||Significance of treatment effect at month 3.|Wilcoxon (Mann-Whitney)|Clustered version of the Wilcoxon test||||||0.416
70959874|NCT04281004|141424084|SUPERIORITY|||||||0.89||||||Significance of treatment effect at month 6.|Wilcoxon (Mann-Whitney)|Clustered version of the Wilcoxon test||||||0.890
70959875|NCT04281004|141424084|SUPERIORITY|||||||0.192||||||Significance of treatment effect at month 12.|Wilcoxon (Mann-Whitney)|Clustered version of the Wilcoxon test||||||0.192
70959876|NCT04281004|141424085|SUPERIORITY|||||||0.057||||||Significance of treatment effect at month 1.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.057
70959877|NCT04281004|141424085|SUPERIORITY|||||||0.528||||||Significance of treatment effect at month 3.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.528
70959878|NCT04281004|141424085|SUPERIORITY|||||||0.21||||||Significance of treatment effect at month 6.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.210
70959879|NCT04281004|141424085|SUPERIORITY|||||||0.853||||||Significance of treatment effect at month 12.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.853
70880051|NCT00975481|141245402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6513||||0.001|TWO_SIDED|95.0|3.5552|13.7474|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||13.7474|3.5552|0.0010
70880052|NCT00975481|141245403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.6388|||<|0.0001|TWO_SIDED|95.0|10.5727|22.7049|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||22.7049|10.5727|<0.0001
70880053|NCT00975481|141245403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.8432|||<|0.0001|TWO_SIDED|95.0|13.7627|25.9238|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||25.9238|13.7627|<0.0001
70880054|NCT00975481|141245403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6121||||0.6029|TWO_SIDED|95.0|-7.7209|4.4967|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.4967|-7.7209|0.6029
70959880|NCT02482870|141424118|SUPERIORITY_OR_OTHER_LEGACY|||||||0.119|TWO_SIDED|||||A priori threshold for statistical significance was 0.05.|Chi-squared|Chi-square value = 2.424; degrees of freedom = 1||Sample size was calculated according to the first 60 patients. To obtain 90% power with an alpha error of 0.05, a total of 378 patients were required. Considering a possible drop-out rate of 2.5% due to unexpected complications, we aimed for 388 patients.||||0.119
70959881|NCT02482870|141424119|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.8|||<|0.0001|TWO_SIDED|95.0|3.0|4.6||A priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||||4.6|3|<0.0001
70959882|NCT02482870|141424120|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.9|||<|0.0001|TWO_SIDED|95.0|0.5|1.4||A priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||||1.4|0.5|<0.0001
70959883|NCT02482870|141424121|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.81|||<|0.0001|TWO_SIDED|95.0|-0.95|-0.67||A priori threshold for statistical significance was 0.05.|t-test, 2 sided|t value = -11.224, degrees of freedom = 773.99||"For each patient, the difference between Cormack-Lehane score and Mallampati class was calculated for each laryngoscope. As an example, the first patient had a Mallampati score 3. Macintosh laryngoscope provided a Cormack-Lehane score of 2, therefore the difference is - 1, calculated as 2 - 3. In the same patient, King Vision video laryngoscope provided a Cormack-Lehane score of 1, therefore the difference is - 2, calculated as 1 - 3. T-test was used to compare the differences."||-0.67|-0.95|<0.0001
70959884|NCT02482870|141424122|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75|TWO_SIDED|||||A priori threshold for statistical significance was 0.05.|Chi-squared, Corrected|Chi-square test with Yates' continuity correction: chi-square = 0.101; degrees of freedom = 1||||||0.75
70959885|NCT01313637|141424147|SUPERIORITY_OR_OTHER||Least squares mean difference|0.16|||<|0.001|TWO_SIDED|95.0|0.122|0.198|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC 125 µg minus Placebo.|||0.198|0.122|<0.001
70959886|NCT01313637|141424147|SUPERIORITY_OR_OTHER||Least squares mean difference|0.124|||<|0.001|TWO_SIDED|95.0|0.086|0.162|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=VI 25 µg minus Placebo.|||0.162|0.086|<0.001
70959887|NCT01313637|141424147|SUPERIORITY_OR_OTHER||Least squares mean difference|0.238|||<|0.001|TWO_SIDED|95.0|0.2|0.276|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 µg minus Placebo.|||0.276|0.200|<0.001
70959888|NCT01313637|141424147|SUPERIORITY_OR_OTHER||Least squares mean difference|0.079|||<|0.001|TWO_SIDED|95.0|0.046|0.112|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 minus UMEC 125 µg.|||0.112|0.046|<0.001
70959889|NCT01313637|141424147|SUPERIORITY_OR_OTHER||Least squares mean difference|0.114|||<|0.001|TWO_SIDED|95.0|0.081|0.148|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 minus VI 25 µg.|||0.148|0.081|<0.001
70959890|NCT03339570|141424153|SUPERIORITY||Mean Difference (Final Values)|18.3|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||Student's t test was used if they were variables adjusted to a normal distribution, or the Mann-Whitney U test if they were non-normal variables.||||<0.01
70880055|NCT00975481|141245403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9241||||0.3477|TWO_SIDED|95.0|-9.0571|3.2089|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.2089|-9.0571|0.3477
70959891|NCT03021954|141424190|SUPERIORITY|||||||0.086|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is in the intervention group, we expect a decrease in the area of the levator hiatus at 40 days and 3 months post-partum. Power 90 % confidence interval β = 0.10, α = 0.05||||0.086
70959892|NCT03021954|141424191|EQUIVALENCE|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is platelet rich plasma can maintain or increase levator ani muscle contractions post-partum||||0.29
70959893|NCT02594826|141424220|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|35.8|||<|0.001|TWO_SIDED|95.0|11.1|114.9|||Mixed Models Analysis|This is the calculated p-value, which is adjusted for age, marital status, prior screening, health insurance, and having a healthcare provider.||||114.9|11.1|<0.001
70959894|NCT02594826|141424221|SUPERIORITY|||||||0.005|||||||Regression, Linear|Controlling for: marital status, education, language spoken at home, health insurance, regular physician, language of physician, ever had Pap test.||The null hypothesis is that the two conditions would not differ in their knowledge following program participation. The study biostatistician conducted full regression models to examine change in knowledge (from pre- to post-program) within each group and across groups over time. The models controlled for relevant covariates.||||0.005
70959895|NCT03581825|141424257|SUPERIORITY|Statistically superiority was concluded if the lower limit of the confidence intervals of the Test lens are greater than 40 points.|Least-Square Mean|56.3|STANDARD_ERROR_OF_MEAN|2.55|||TWO_SIDED|95.0|51.2|61.4|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||61.4|51.2|
70959896|NCT03581825|141424258|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control was concluded if the lower confidence limit of LSM difference was above the non-inferiority margin -5.|Least-Square Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|-0.5|7.4|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean Difference was calculated as Test minus Control|||7.4|-0.5|
70959897|NCT01668667|141424259|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|-2.57|STANDARD_ERROR_OF_MEAN|0.745||0.014|TWO_SIDED|95.0|-4.62|-0.52|||ANCOVA|No adjustment for multiplicity will be made for these analyses.|The change from baseline data is analyzed using an ANCOVA model with treatment and pooled site as the main effects and the baseline IRLS Rating Scale total score as a covariate.|The null hypothesis for this study is that there is no difference between GEn and placebo in the change from Baseline to the end of treatment in the IRLS Rating Scale total score. All comparisons will be made at the two-sided 0.05 level of significance.||-0.52|-4.62|0.014
70959898|NCT01668667|141424259|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|-2.61|STANDARD_ERROR_OF_MEAN|0.764||0.014|TWO_SIDED|95.0|-4.68|-0.54|||ANCOVA|No adjustment for multiplicity will be made for these analyses.|The change from baseline data is analyzed using an ANCOVA model with treatment and pooled site as the main effects and the baseline IRLS Rating Scale total score as a covariate.|The null hypothesis for this study is that there is no difference between GEn and placebo in the change from Baseline to the end of treatment in the IRLS Rating Scale total score. All comparisons will be made at the two-sided 0.05 level of significance.||-0.54|-4.68|0.014
70959899|NCT01668667|141424259|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|-1.55|STANDARD_ERROR_OF_MEAN|0.767||0.144|TWO_SIDED|95.0|-3.63|0.53|||ANCOVA|No adjustment for multiplicity will be made for these analyses.|The change from baseline data is analyzed using an ANCOVA model with treatment and pooled site as the main effects and the baseline IRLS Rating Scale total score as a covariate|The null hypothesis for this study is that there is no difference between GEn and placebo in the change from Baseline to the end of treatment in the IRLS Rating Scale total score. All comparisons will be made at the two-sided 0.05 level of significance.||0.53|-3.63|0.144
70959900|NCT01668667|141424260|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.26||||0.004|TWO_SIDED|95.0|1.3|3.95|||Regression, Logistic||The analysis method used was logistic regression with terms of pooled site and treatment.|"The null hypothesis for this study is that there is no difference between GEn and placebo in the proportion of subjects who are responders with much improved or very much improved on the investigator-rated CGI-I at the end of treatment."||3.95|1.30|0.004
70959901|NCT01668667|141424260|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.15||||0.007|TWO_SIDED|95.0|1.23|3.77|||Regression, Logistic||The analysis method used was logistic regression with terms of pooled site and treatment.|"The null hypothesis for this study is that there is no difference between GEn and placebo in the proportion of subjects who are responders with much improved or very much improved on the investigator-rated CGI-I at the end of treatment."||3.77|1.23|0.007
70880056|NCT00975481|141245403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0908||||0.9769|TWO_SIDED|95.0|-6.085|6.2667|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.2667|-6.0850|0.9769
70880057|NCT00975481|141245403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.2509|||<|0.0001|TWO_SIDED|95.0|-24.3155|-12.1864|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-12.1864|-24.3155|<0.0001
70880058|NCT00975481|141245403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5629|||<|0.0001|TWO_SIDED|95.0|-25.6616|-13.4642|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-13.4642|-25.6616|<0.0001
70880059|NCT00975481|141245403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.548|||<|0.0001|TWO_SIDED|95.0|-22.7036|-10.3923|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-10.3923|-22.7036|<0.0001
70880060|NCT00975481|141245403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.4554|||<|0.0001|TWO_SIDED|95.0|-27.4199|-15.4908|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-15.4908|-27.4199|<0.0001
70880061|NCT00975481|141245403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.7673|||<|0.0001|TWO_SIDED|95.0|-28.7925|-16.7422||Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.|Mixed Models Analysis|||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-16.7422|-28.7925|<0.0001
70880062|NCT00975481|141245403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.7524|||<|0.0001|TWO_SIDED|95.0|-25.8485|-13.6563|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-13.6563|-25.8485|<0.0001
70880063|NCT00975481|141245403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.0888||||0.0006|TWO_SIDED|95.0|5.3225|18.8551|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||18.8551|5.3225|0.0006
70880064|NCT00975481|141245403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0768||||0.0038|TWO_SIDED|95.0|3.3132|16.8403|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||16.8403|3.3132|0.0038
70880065|NCT00975481|141245403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1875||||0.2257|TWO_SIDED|95.0|-10.989|2.6139|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||2.6139|-10.9890|0.2257
70880066|NCT00975481|141245403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8589||||0.8042|TWO_SIDED|95.0|-7.6927|5.975|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.9750|-7.6927|0.8042
70880067|NCT00975481|141245403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6335||||0.6399|TWO_SIDED|95.0|-8.5177|5.2506|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.2506|-8.5177|0.6399
70880068|NCT00975481|141245403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2763|||<|0.0001|TWO_SIDED|95.0|-23.0228|-9.5229|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-9.5229|-23.0228|<0.0001
70880069|NCT00975481|141245403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.9477||||0.0002|TWO_SIDED|95.0|-19.7374|-6.158|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-6.1580|-19.7374|0.0002
70959902|NCT01668667|141424260|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.24||||0.005|TWO_SIDED|95.0|1.27|3.94|||Regression, Logistic||The analysis method used was logistic regression with terms of pooled site and treatment.|"The null hypothesis for this study is that there is no difference between GEn and placebo in the proportion of subjects who are responders with much improved or very much improved on the investigator-rated CGI-I at the end of treatment."||3.94|1.27|0.005
70880070|NCT00975481|141245403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7223||||0.0001|TWO_SIDED|95.0|-20.572|-6.8727|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-6.8727|-20.5720|0.0001
70880071|NCT00975481|141245403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.2643|||<|0.0001|TWO_SIDED|95.0|-20.9226|-7.606|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-7.6060|-20.9226|<0.0001
70880072|NCT00975481|141245403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9356||||0.0016|TWO_SIDED|95.0|-17.6548|-4.2165|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-4.2165|-17.6548|0.0016
70880073|NCT00975481|141245403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.7103||||0.0008|TWO_SIDED|95.0|-18.5055|-4.9151|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-4.9151|-18.5055|0.0008
70880074|NCT00975481|141245404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.009|||<|0.0001|TWO_SIDED|95.0|13.7265|34.2916|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||34.2916|13.7265|<0.0001
70880075|NCT00975481|141245404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.4156|||<|0.0001|TWO_SIDED|95.0|19.116|39.7151|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||39.7151|19.1160|<0.0001
70880076|NCT00975481|141245404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3979||||0.2239|TWO_SIDED|95.0|-16.7479|3.9521|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.9521|-16.7479|0.2239
70880077|NCT00975481|141245404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1396||||0.4326|TWO_SIDED|95.0|-14.5328|6.2526|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.2526|-14.5328|0.4326
70880078|NCT00975481|141245404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7283||||0.7447|TWO_SIDED|95.0|-12.195|8.7383|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.7383|-12.1950|0.7447
70880079|NCT00975481|141245404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.4069|||<|0.0001|TWO_SIDED|95.0|-40.6795|-20.1343|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-20.1343|-40.6795|<0.0001
70880080|NCT00975481|141245404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.1487|||<|0.0001|TWO_SIDED|95.0|-38.4812|-17.8161|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-17.8161|-38.4812|<0.0001
70880081|NCT00975481|141245404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.7374|||<|0.0001|TWO_SIDED|95.0|-36.1651|-15.3096|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-15.3096|-36.1651|<0.0001
70880082|NCT00975481|141245404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.8134|||<|0.0001|TWO_SIDED|95.0|-45.9257|-25.7012|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-25.7012|-45.9257|<0.0001
70959903|NCT01668667|141424261|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022|TWO_SIDED||||||ANOVA|||For the mean change from Baseline for IRLS Rating Scale total score at the EOT, the linear contrast test based on an analysis of variance with treatment effect was used to detect linear dose-response trends across increasing levels of GEn dosage.||||0.022
70959904|NCT01668667|141424261|SUPERIORITY_OR_OTHER_LEGACY|||||||0.072|TWO_SIDED||||||ANOVA|||Overall treatment effect||||0.072
70959905|NCT01668667|141424262|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|TWO_SIDED|||||A significant p-value will indicate a nonzero linear effect across increasing levels of GEn dosage.|Cochran-Armitage trend test|||||||0.012
70959906|NCT00511901|141424263|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.7||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.02
70959907|NCT00511901|141424264|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8||||1||95.0|||||Wilcoxon (Mann-Whitney)|||FIM at 3 weeks||||1.00
70959908|NCT00511901|141424264|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.3||||0.17||95.0|||||Wilcoxon (Mann-Whitney)|||FIM at 8 weeks||||0.17
70959909|NCT00511901|141424264|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.59||95.0|||||Wilcoxon (Mann-Whitney)|||FIM at 12 weeks||||0.59
70959910|NCT00511901|141424265|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.3||||0.21||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.21
70959911|NCT00511901|141424266|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.66||95.0|||||Wilcoxon (Mann-Whitney)|||Grip strength at 3 weeks||||0.66
70959912|NCT00511901|141424266|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||1||95.0|||||Wilcoxon (Mann-Whitney)|||Grip strength at 8 weeks||||1.00
70959913|NCT00511901|141424266|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.6||||0.53||95.0|||||Wilcoxon (Mann-Whitney)|||Grip strength at 12 weeks||||0.53
70959914|NCT00511901|141424267|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.96||95.0|||||Wilcoxon (Mann-Whitney)|||SPPB at 3 weeks||||0.96
70959915|NCT00511901|141424267|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||1||95.0|||||Wilcoxon (Mann-Whitney)|||SPPB at 8 weeks||||1.00
70959916|NCT00511901|141424267|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.66||95.0|||||Wilcoxon (Mann-Whitney)|||SPPB at 12 weeks||||0.66
70959917|NCT00511901|141424268|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6||||0.64||95.0|||||Wilcoxon (Mann-Whitney)|||FACIT at 3 weeks||||0.64
70959918|NCT00511901|141424268|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5||||0.83||95.0|||||Wilcoxon (Mann-Whitney)|||FACIT at 8 weeks||||0.83
70959919|NCT00511901|141424268|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1||||0.46||95.0|||||Wilcoxon (Mann-Whitney)|||FACIT at 12 weeks||||0.46
70959920|NCT00511901|141424269|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.57||||0.37||95.0|||||Wilcoxon (Mann-Whitney)|||Activity Counts at 3 weeks||||0.37
70959921|NCT00511901|141424269|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.39||||0.69||95.0|||||Wilcoxon (Mann-Whitney)|||Activity Counts at 8 weeks||||0.69
70959922|NCT00511901|141424269|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.15||||0.36||95.0|||||Wilcoxon (Mann-Whitney)|||Activity Counts at 12 weeks||||0.36
70959923|NCT00511901|141424270|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.5||||0.97||95.0|||||Wilcoxon (Mann-Whitney)|||POMS at 3 weeks||||0.97
70959924|NCT00511901|141424270|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.0||||0.46||95.0|||||Wilcoxon (Mann-Whitney)|||POMS at 8 weeks||||0.46
70959925|NCT00511901|141424270|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.0||||0.68||95.0|||||Wilcoxon (Mann-Whitney)|||POMS at 12 weeks||||0.68
70959926|NCT00178126|141424271|SUPERIORITY_OR_OTHER|||||||0.04|||||||Fisher Exact|||||||0.04
70959927|NCT04262817|141424284|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||Comparison of Nicotine type.||||0.01
70959928|NCT04262817|141424284|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|||Comparison of Flavor type.||||0.34
70959929|NCT04262817|141424285|SUPERIORITY|||||||0.38|||||||Mixed Models Analysis|||Comparison of Nicotine type.||||0.38
70959930|NCT04262817|141424285|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||Comparison of Flavor type.||||0.85
70959931|NCT04262817|141424286|SUPERIORITY|||||||0.39|||||||Mixed Models Analysis|||Comparison of Nicotine type.||||0.39
70959932|NCT04262817|141424286|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||Comparison of Flavor type.||||0.77
70959933|NCT04262817|141424287|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||Comparison of Nicotine type.||||0.43
70959934|NCT04262817|141424287|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||Comparison of Flavor type.||||0.05
70959935|NCT04262817|141424288|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||Comparison of Nicotine type.||||0.05
70959936|NCT04262817|141424288|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||Comparison of Flavor type.||||0.04
70959937|NCT04262817|141424289|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||Comparison of Nicotine type.||||0.01
70959938|NCT04262817|141424289|SUPERIORITY|||||||0.38|||||||Mixed Models Analysis|||Comparison of Flavor type.||||0.38
70959939|NCT01182194|141424290|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|92.5|||||TWO_SIDED|90.0|85.53|100.03|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||100.03|85.53|
70959940|NCT01182194|141424291|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.76|||||TWO_SIDED|90.0|95.66|101.96|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.96|95.66|
70959941|NCT01182194|141424292|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.47|||||TWO_SIDED|90.0|95.35|101.7|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.70|95.35|
70959942|NCT01182194|141424293|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|101.45|||||TWO_SIDED|90.0|94.36|109.08|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||109.08|94.36|
70959943|NCT01182194|141424294|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.54|||||TWO_SIDED|90.0|94.55|102.71|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||102.71|94.55|
70959944|NCT01182194|141424295|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.7|||||TWO_SIDED|90.0|96.07|103.46|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||103.46|96.07|
70959945|NCT01013597|141424312|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98|||||||t-test, 2 sided|||||||0.98
70959946|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.1|1.78||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.78|1.10|
70959947|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.9|1.32||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.32|0.90|
70959948|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.6|||||TWO_SIDED|95.0|1.19|2.13||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||2.13|1.19|
70959949|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.2|||||TWO_SIDED|95.0|0.93|1.62||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.62|0.93|
70959950|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|12.1|||||TWO_SIDED|95.0|8.63|17.08||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||17.08|8.63|
70880083|NCT00975481|141245404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.5552|||<|0.0001|TWO_SIDED|95.0|-43.7675|-23.3429|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-23.3429|-43.7675|<0.0001
70959951|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.5|||||TWO_SIDED|95.0|1.82|3.48||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||3.48|1.82|
70880084|NCT00975481|141245404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.1439|||<|0.0001|TWO_SIDED|95.0|-41.4754|-20.8124|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-20.8124|-41.4754|<0.0001
70880085|NCT00975481|141245405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.8779|||<|0.0001|TWO_SIDED|95.0|19.5658|30.1899|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||30.1899|19.5658|<0.0001
70880086|NCT00975481|141245405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.9857|||<|0.0001|TWO_SIDED|95.0|20.667|31.3043|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||31.3043|20.6670|<0.0001
70880087|NCT00975481|141245405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0544||||0.4489|TWO_SIDED|95.0|-3.2911|7.3998|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||7.3998|-3.2911|0.4489
70880088|NCT00975481|141245405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5743||||0.8329|TWO_SIDED|95.0|-4.7941|5.9427|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.9427|-4.7941|0.8329
70880089|NCT00975481|141245405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6863||||0.5387|TWO_SIDED|95.0|-3.7203|7.0929|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||7.0929|-3.7203|0.5387
70880090|NCT00975481|141245405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.8235|||<|0.0001|TWO_SIDED|95.0|-28.1283|-17.5187|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-17.5187|-28.1283|<0.0001
70880091|NCT00975481|141245405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.3036|||<|0.0001|TWO_SIDED|95.0|-29.64|-18.9672|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-18.9672|-29.6400|<0.0001
70880092|NCT00975481|141245405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.1916|||<|0.0001|TWO_SIDED|95.0|-28.5768|-17.8064|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-17.8064|-28.5768|<0.0001
70880093|NCT00975481|141245405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.9313|||<|0.0001|TWO_SIDED|95.0|-29.1559|-18.7066|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-18.7066|-29.1559|<0.0001
70880094|NCT00975481|141245405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.4114|||<|0.0001|TWO_SIDED|95.0|-30.6869|-20.1358|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-20.1358|-30.6869|<0.0001
70880095|NCT00975481|141245405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.2994|||<|0.0001|TWO_SIDED|95.0|-29.6361|-18.9626|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-18.9626|-29.6361|<0.0001
70959952|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.8|||||TWO_SIDED|95.0|1.98|3.87||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||3.87|1.98|
70880096|NCT00975481|141245405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4301||||0.5349|TWO_SIDED|95.0|-5.9725|3.1123|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.1123|-5.9725|0.5349
70880097|NCT00975481|141245405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.1367||||0.0001|TWO_SIDED|95.0|-13.6684|-4.605|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-4.6050|-13.6684|0.0001
70880098|NCT00975481|141245405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3357||||0.5637|TWO_SIDED|95.0|-3.2244|5.8958|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.8958|-3.2244|0.5637
70880099|NCT00975481|141245405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4065||||0.8612|TWO_SIDED|95.0|-4.1779|4.9909|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.9909|-4.1779|0.8612
70880100|NCT00975481|141245405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9175||||0.6954|TWO_SIDED|95.0|-3.7022|5.5373|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.5373|-3.7022|0.6954
70880101|NCT00975481|141245405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7658||||0.2287|TWO_SIDED|95.0|-1.7552|7.2868|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||7.2868|-1.7552|0.2287
70880102|NCT00975481|141245405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8366||||0.4267|TWO_SIDED|95.0|-2.7158|6.389|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.3890|-2.7158|0.4267
70880103|NCT00975481|141245405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3476||||0.314|TWO_SIDED|95.0|-2.2429|6.9381|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.9381|-2.2429|0.3140
70880104|NCT00975481|141245405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.4724|||<|0.0001|TWO_SIDED|95.0|5.9992|14.9456|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||14.9456|5.9992|<0.0001
70880105|NCT00975481|141245405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.5432|||<|0.0001|TWO_SIDED|95.0|5.032|14.0544|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||14.0544|5.0320|<0.0001
70880106|NCT00975481|141245405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0542|||<|0.0001|TWO_SIDED|95.0|5.494|14.6144|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||14.6144|5.4940|<0.0001
70880107|NCT00975481|141245406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.4728|||<|0.0001|TWO_SIDED|95.0|9.4718|19.4737|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||19.4737|9.4718|<0.0001
70959953|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.9|||||TWO_SIDED|95.0|2.0|4.08||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||4.08|2.00|
70959954|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.64|1.21||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.21|0.64|
70880108|NCT00975481|141245406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.7284|||<|0.0001|TWO_SIDED|95.0|14.7131|24.7437|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||24.7437|14.7131|<0.0001
70880109|NCT00975481|141245406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2088||||0.9348|TWO_SIDED|95.0|-4.8289|5.2466|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.2466|-4.8289|0.9348
70880110|NCT00975481|141245406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7271||||0.5009|TWO_SIDED|95.0|-6.7841|3.3299|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.3299|-6.7841|0.5009
70880111|NCT00975481|141245406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3325||||0.8975|TWO_SIDED|95.0|-5.4245|4.7595|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.7595|-5.4245|0.8975
70880112|NCT00975481|141245406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.264|||<|0.0001|TWO_SIDED|95.0|-19.266|-9.2619|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-9.2619|-19.2660|<0.0001
70880113|NCT00975481|141245406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.1999|||<|0.0001|TWO_SIDED|95.0|-21.2294|-11.1704|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-11.1704|-21.2294|<0.0001
70880114|NCT00975481|141245406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.8053|||<|0.0001|TWO_SIDED|95.0|-19.8822|-9.7283|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-9.7283|-19.8822|<0.0001
70880115|NCT00975481|141245406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5195|||<|0.0001|TWO_SIDED|95.0|-24.4361|-14.603|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-14.6030|-24.4361|<0.0001
70880116|NCT00975481|141245406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.4555|||<|0.0001|TWO_SIDED|95.0|-26.423|-16.488|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-16.4880|-26.4230|<0.0001
70880117|NCT00975481|141245406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.0609|||<|0.0001|TWO_SIDED|95.0|-25.0872|-15.0345|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-15.0345|-25.0872|<0.0001
70880118|NCT00975481|141245407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1634|||<|0.0001|TWO_SIDED|95.0|1.9014|4.4254|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.4254|1.9014|<0.0001
70880119|NCT00975481|141245407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6706|||<|0.0001|TWO_SIDED|95.0|3.4066|5.9346|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.9346|3.4066|<0.0001
70959955|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.9|||||TWO_SIDED|95.0|1.39|2.51||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||2.51|1.39|
70959956|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.9|||||TWO_SIDED|95.0|1.56|2.41||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||2.41|1.56|
70959957|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.72|1.28||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.28|0.72|
70959958|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|5.2|||||TWO_SIDED|95.0|3.67|7.33||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||7.33|3.67|
70959959|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.08|1.73||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.73|1.08|
70959960|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.81|1.19||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.19|0.81|
70959961|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.07|1.77||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.77|1.07|
70959962|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4||||||95.0|1.01|1.8||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.80|1.01|
70880120|NCT00975481|141245407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1478||||0.8184|TWO_SIDED|95.0|-1.1217|1.4173|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.4173|-1.1217|0.8184
70959963|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.7|||||TWO_SIDED|95.0|1.3|2.15||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||2.15|1.30|
70959964|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.6|||||TWO_SIDED|95.0|1.24|2.12||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||2.12|1.24|
70959965|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.03|1.79||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.79|1.03|
70959966|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.5||||||95.0|1.11|1.98||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.98|1.11|
70959967|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.6|||||TWO_SIDED|95.0|1.16|2.12||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||2.12|1.16|
70959968|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.86|1.47||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.47|0.86|
70959969|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.16|1.69||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.69|1.16|
70880121|NCT00975481|141245407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2211||||0.7324|TWO_SIDED|95.0|-1.054|1.4963|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.4963|-1.0540|0.7324
70880122|NCT00975481|141245407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0946||||0.8844|TWO_SIDED|95.0|-1.1898|1.3791|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.3791|-1.1898|0.8844
70880123|NCT00975481|141245407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0156|||<|0.0001|TWO_SIDED|95.0|-4.2754|-1.7558|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-1.7558|-4.2754|<0.0001
70880124|NCT00975481|141245407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9423|||<|0.0001|TWO_SIDED|95.0|-4.2101|-1.6745|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-1.6745|-4.2101|<0.0001
70880125|NCT00975481|141245407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0688|||<|0.0001|TWO_SIDED|95.0|-4.3484|-1.7891|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-1.7891|-4.3484|<0.0001
70880126|NCT00975481|141245407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5228|||<|0.0001|TWO_SIDED|95.0|-5.7651|-3.2805|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.2805|-5.7651|<0.0001
70880127|NCT00975481|141245407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4495|||<|0.0001|TWO_SIDED|95.0|-5.7031|-3.1959|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.1959|-5.7031|<0.0001
70959970|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.2|||||TWO_SIDED|95.0|0.87|1.54||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.54|0.87|
70880128|NCT00975481|141245407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.576|||<|0.0001|TWO_SIDED|95.0|-5.8438|-3.3081|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.3081|-5.8438|<0.0001
70880129|NCT00975481|141245408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.0798|||<|0.0001|TWO_SIDED|95.0|34.0453|58.1142|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||58.1142|34.0453|<0.0001
70880130|NCT00975481|141245408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.8771|||<|0.0001|TWO_SIDED|95.0|37.8247|61.9295|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||61.9295|37.8247|<0.0001
70880131|NCT00975481|141245408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5797||||0.9248|TWO_SIDED|95.0|-12.6918|11.5325|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||11.5325|-12.6918|0.9248
70880132|NCT00975481|141245408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3632||||0.5857|TWO_SIDED|95.0|-15.5264|8.8|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.8000|-15.5264|0.5857
70880133|NCT00975481|141245408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4225||||0.4768|TWO_SIDED|95.0|-7.827|16.6719|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||16.6719|-7.8270|0.4768
70880134|NCT00975481|141245408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.6594|||<|0.0001|TWO_SIDED|95.0|-58.6804|-34.6385|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-34.6385|-58.6804|<0.0001
70880135|NCT00975481|141245408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-49.443|||<|0.0001|TWO_SIDED|95.0|-61.5346|-37.3514|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-37.3514|-61.5346|<0.0001
70880136|NCT00975481|141245408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.6573|||<|0.0001|TWO_SIDED|95.0|-53.86|-29.4546|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-29.4546|-53.8600|<0.0001
70880137|NCT00975481|141245408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.4567|||<|0.0001|TWO_SIDED|95.0|-62.2925|-38.621|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-38.6210|-62.2925|<0.0001
70880138|NCT00975481|141245408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-53.2403|||<|0.0001|TWO_SIDED|95.0|-65.1923|-41.2882|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-41.2882|-65.1923|<0.0001
70880139|NCT00975481|141245408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-45.4546|||<|0.0001|TWO_SIDED|95.0|-57.5459|-33.3633|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-33.3633|-57.5459|<0.0001
70880140|NCT00975481|141245409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.845|||<|0.0001|TWO_SIDED|95.0|34.6464|59.0436|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||59.0436|34.6464|<0.0001
70880141|NCT00975481|141245409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|57.5013|||<|0.0001|TWO_SIDED|95.0|45.3036|69.6991|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||69.6991|45.3036|<0.0001
70880142|NCT00975481|141245409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.0913||||0.4129|TWO_SIDED|95.0|-17.3421|7.1595|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||7.1595|-17.3421|0.4129
70959971|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.3|||||TWO_SIDED|95.0|0.94|1.84||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.84|0.94|
70959972|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.4|||||TWO_SIDED|95.0|2.03|2.87||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||2.87|2.03|
70880143|NCT00975481|141245409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1893||||0.8488|TWO_SIDED|95.0|-13.4954|11.1168|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||11.1168|-13.4954|0.8488
70880144|NCT00975481|141245409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1995||||0.4086|TWO_SIDED|95.0|-7.1963|17.5954|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||17.5954|-7.1963|0.4086
70880145|NCT00975481|141245409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.9363|||<|0.0001|TWO_SIDED|95.0|-64.1108|-39.7618|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-39.7618|-64.1108|<0.0001
70880146|NCT00975481|141245409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-48.0343|||<|0.0001|TWO_SIDED|95.0|-60.2801|-35.7885|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-35.7885|-60.2801|<0.0001
70880147|NCT00975481|141245409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.6455|||<|0.0001|TWO_SIDED|95.0|-53.9964|-29.2946|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-29.2946|-53.9964|<0.0001
70880148|NCT00975481|141245409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-62.5926|||<|0.0001|TWO_SIDED|95.0|-74.5881|-50.5971|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-50.5971|-74.5881|<0.0001
70880149|NCT00975481|141245409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-58.6906|||<|0.0001|TWO_SIDED|95.0|-70.7965|-46.5847|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-46.5847|-70.7965|<0.0001
70880150|NCT00975481|141245409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-52.3018|||<|0.0001|TWO_SIDED|95.0|-64.5427|-40.0609|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-40.0609|-64.5427|<0.0001
70880151|NCT00975481|141245410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.4604||||0.0016|TWO_SIDED|95.0|6.321|26.5998|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||26.5998|6.3210|0.0016
70880152|NCT00975481|141245410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.9971|||<|0.0001|TWO_SIDED|95.0|17.8247|38.1696|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||38.1696|17.8247|<0.0001
70880153|NCT00975481|141245410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1425||||0.8254|TWO_SIDED|95.0|-11.3591|9.0742|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||9.0742|-11.3591|0.8254
70880154|NCT00975481|141245410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.747||||0.8858|TWO_SIDED|95.0|-9.5075|11.0015|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||11.0015|-9.5075|0.8858
70880155|NCT00975481|141245410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4279||||0.5128|TWO_SIDED|95.0|-6.8972|13.7529|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||13.7529|-6.8972|0.5128
70880156|NCT00975481|141245410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.6028||||0.0008|TWO_SIDED|95.0|-27.7485|-7.4572|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-7.4572|-27.7485|0.0008
70880157|NCT00975481|141245410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.7134||||0.0028|TWO_SIDED|95.0|-25.9136|-5.5132|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-5.5132|-25.9136|0.0028
70880158|NCT00975481|141245410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.0325||||0.0135|TWO_SIDED|95.0|-23.3295|-2.7355|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-2.7355|-23.3295|0.0135
70880159|NCT00975481|141245410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.1396|||<|0.0001|TWO_SIDED|95.0|-39.1071|-19.1721|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-19.1721|-39.1071|<0.0001
70880160|NCT00975481|141245410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.2502|||<|0.0001|TWO_SIDED|95.0|-37.3224|-17.178|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-17.1780|-37.3224|<0.0001
70880161|NCT00975481|141245410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.5693|||<|0.0001|TWO_SIDED|95.0|-34.7614|-14.3772|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-14.3772|-34.7614|<0.0001
70880162|NCT00975481|141245411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2535||||0.0005|TWO_SIDED|95.0|0.5623|1.9446|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.9446|0.5623|0.0005
70880163|NCT00975481|141245411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.501|||<|0.0001|TWO_SIDED|95.0|2.8073|4.1948|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.1948|2.8073|<0.0001
70880164|NCT00975481|141245411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3418||||0.3347|TWO_SIDED|95.0|-0.3559|1.0396|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.0396|-0.3559|0.3347
70959973|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.84|1.13||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||1.13|0.84|
70880165|NCT00975481|141245411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3208||||0.3678|TWO_SIDED|95.0|-0.3808|1.0225|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.0225|-0.3808|0.3678
70880166|NCT00975481|141245411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036||||0.9197|TWO_SIDED|95.0|-0.6686|0.7406|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.7406|-0.6686|0.9197
70880167|NCT00975481|141245411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9117||||0.0099|TWO_SIDED|95.0|-1.6013|-0.222|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-0.2220|-1.6013|0.0099
70880168|NCT00975481|141245411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9326||||0.0088|TWO_SIDED|95.0|-1.6269|-0.2384|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-0.2384|-1.6269|0.0088
70880169|NCT00975481|141245411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2175||||0.0008|TWO_SIDED|95.0|-1.9171|-0.5178|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-0.5178|-1.9171|0.0008
70880170|NCT00975481|141245411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1592|||<|0.0001|TWO_SIDED|95.0|-3.838|-2.4804|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-2.4804|-3.8380|<0.0001
70880171|NCT00975481|141245411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1802|||<|0.0001|TWO_SIDED|95.0|-3.8656|-2.4947|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-2.4947|-3.8656|<0.0001
70880172|NCT00975481|141245411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.465|||<|0.0001|TWO_SIDED|95.0|-4.1583|-2.7717|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-2.7717|-4.1583|<0.0001
70880173|NCT00975481|141245412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.2943|||<|0.0001|TWO_SIDED|95.0|4.0783|6.5102|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.5102|4.0783|<0.0001
70880174|NCT00975481|141245412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8983|||<|0.0001|TWO_SIDED|95.0|5.6799|8.1167|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.1167|5.6799|<0.0001
70959974|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.3|||||TWO_SIDED|95.0|1.92|2.76||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||2.76|1.92|
70959975|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.9|||||TWO_SIDED|95.0|1.55|2.42||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||2.42|1.55|
70880175|NCT00975481|141245412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6545||||0.2917|TWO_SIDED|95.0|-0.5676|1.8767|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.8767|-0.5676|0.2917
70880176|NCT00975481|141245412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8489||||0.1738|TWO_SIDED|95.0|-0.3784|2.0763|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||2.0763|-0.3784|0.1738
70880177|NCT00975481|141245412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9372||||0.1373|TWO_SIDED|95.0|-0.3024|2.1767|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||2.1767|-0.3024|0.1373
70880178|NCT00975481|141245412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6397|||<|0.0001|TWO_SIDED|95.0|-5.8537|-3.4257|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.4257|-5.8537|<0.0001
70880179|NCT00975481|141245412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4453|||<|0.0001|TWO_SIDED|95.0|-5.6662|-3.2244|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.2244|-5.6662|<0.0001
70959976|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.2|||||TWO_SIDED|95.0|1.84|2.67||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||2.67|1.84|
70880180|NCT00975481|141245412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3571|||<|0.0001|TWO_SIDED|95.0|-5.5887|-3.1255|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.1255|-5.5887|<0.0001
70880181|NCT00975481|141245412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.2437|||<|0.0001|TWO_SIDED|95.0|-7.4397|-5.0477|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-5.0477|-7.4397|<0.0001
70880182|NCT00975481|141245412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0493|||<|0.0001|TWO_SIDED|95.0|-7.2568|-4.8419|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-4.8419|-7.2568|<0.0001
70880183|NCT00975481|141245412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9611|||<|0.0001|TWO_SIDED|95.0|-7.1812|-4.741|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-4.7410|-7.1812|<0.0001
70880184|NCT00975481|141245413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.6205|||<|0.0001|TWO_SIDED|95.0|-33.1192|-20.1219|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-20.1219|-33.1192|<0.0001
70880185|NCT00975481|141245413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.5724|||<|0.0001|TWO_SIDED|95.0|-39.1073|-26.0375|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-26.0375|-39.1073|<0.0001
70880186|NCT00975481|141245413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8966||||0.5685|TWO_SIDED|95.0|-4.6607|8.454|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.4540|-4.6607|0.5685
70880187|NCT00975481|141245413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5761||||0.2848|TWO_SIDED|95.0|-10.159|3.0068|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.0068|-10.1590|0.2848
70880188|NCT00975481|141245413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1754||||0.344|TWO_SIDED|95.0|-9.7855|3.4347|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.4347|-9.7855|0.3440
70880189|NCT00975481|141245413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.5172|||<|0.0001|TWO_SIDED|95.0|22.0454|34.989|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||34.9890|22.0454|<0.0001
70880190|NCT00975481|141245413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.0445|||<|0.0001|TWO_SIDED|95.0|16.5383|29.5506|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||29.5506|16.5383|<0.0001
70880191|NCT00975481|141245413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.4452|||<|0.0001|TWO_SIDED|95.0|16.8772|30.0131|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||30.0131|16.8772|<0.0001
70880192|NCT00975481|141245413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.469|||<|0.0001|TWO_SIDED|95.0|28.1136|40.8244|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||40.8244|28.1136|<0.0001
70959977|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.9|||||TWO_SIDED|95.0|4.13|5.93||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||5.93|4.13|
70880193|NCT00975481|141245413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.9963|||<|0.0001|TWO_SIDED|95.0|22.5734|35.4192|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||35.4192|22.5734|<0.0001
70959978|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.9|||||TWO_SIDED|95.0|2.41|3.49||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||3.49|2.41|
70880194|NCT00975481|141245413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.397|||<|0.0001|TWO_SIDED|95.0|22.8946|35.8994|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||35.8994|22.8946|<0.0001
70880195|NCT00975481|141245414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.6044|||<|0.0001|TWO_SIDED|95.0|33.4091|59.7996|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||59.7996|33.4091|<0.0001
70880196|NCT00975481|141245414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.7222|||<|0.0001|TWO_SIDED|95.0|37.5038|63.9407|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||63.9407|37.5038|<0.0001
70880197|NCT00975481|141245414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6987||||0.9174|TWO_SIDED|95.0|-13.9815|12.584|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||12.5840|-13.9815|0.9174
70880198|NCT00975481|141245414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5629||||0.5002|TWO_SIDED|95.0|-17.9006|8.7749|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.7749|-17.9006|0.5002
70959979|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.9|||||TWO_SIDED|95.0|2.34|3.52||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||3.52|2.34|
70959980|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.9|||||TWO_SIDED|95.0|4.01|5.93||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||5.93|4.01|
70959981|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.3|||||TWO_SIDED|95.0|1.91|2.79||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||2.79|1.91|
70959982|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.3|||||TWO_SIDED|95.0|2.02|2.66||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||2.66|2.02|
70959983|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.0|||||TWO_SIDED|95.0|2.44|3.6||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||3.60|2.44|
70959984|NCT00427895|141424317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.2|||||TWO_SIDED|95.0|3.31|5.31||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||5.31|3.31|
70959985|NCT00427895|141424318|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|Difference in Percentage|39.2|||||TWO_SIDED|95.0|33.0|45.1||||||||45.1|33.0|
70959986|NCT00427895|141424319|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.4|||||TWO_SIDED|95.0|2.32|5.09||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||5.09|2.32|
70880199|NCT00975481|141245414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3982||||0.3482|TWO_SIDED|95.0|-7.0337|19.8301|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||19.8301|-7.0337|0.3482
70959987|NCT00427895|141424319|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.6|||||TWO_SIDED|95.0|1.13|2.16||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.16|1.13|
70880200|NCT00975481|141245414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.3031|||<|0.0001|TWO_SIDED|95.0|-60.4869|-34.1193|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-34.1193|-60.4869|<0.0001
70880201|NCT00975481|141245414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.1672|||<|0.0001|TWO_SIDED|95.0|-64.4276|-37.9069|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-37.9069|-64.4276|<0.0001
70880202|NCT00975481|141245414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.2062|||<|0.0001|TWO_SIDED|95.0|-53.589|-26.8234|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-26.8234|-53.5890|<0.0001
70880203|NCT00975481|141245414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.421|||<|0.0001|TWO_SIDED|95.0|-64.3974|-38.4445|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-38.4445|-64.3974|<0.0001
70880204|NCT00975481|141245414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-55.2851|||<|0.0001|TWO_SIDED|95.0|-68.3904|-42.1798|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-42.1798|-68.3904|<0.0001
70880205|NCT00975481|141245414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.3241|||<|0.0001|TWO_SIDED|95.0|-57.5825|-31.0656|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-31.0656|-57.5825|<0.0001
70880206|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.3823|||<|0.0001|TWO_SIDED|95.0|-62.1244|-30.6401|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI was obtained from the model.||-30.6401|-62.1244|<0.0001
70880207|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.5199|||<|0.0001|TWO_SIDED|95.0|-67.2633|-35.7765|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-35.7765|-67.2633|<0.0001
70880208|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0366||||0.4524|TWO_SIDED|95.0|-9.7924|21.8657|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||21.8657|-9.7924|0.4524
70880209|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4423||||0.762|TWO_SIDED|95.0|-13.4599|18.3446|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||18.3446|-13.4599|0.7620
70880210|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1573||||0.9846|TWO_SIDED|95.0|-15.8609|16.1754|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||16.1754|-15.8609|0.9846
70880211|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|52.4189|||<|0.0001|TWO_SIDED|95.0|36.7157|68.1221|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||68.1221|36.7157|<0.0001
70959988|NCT00427895|141424319|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.3|||||TWO_SIDED|95.0|0.88|1.98||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||1.98|0.88|
70880212|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|48.8246|||<|0.0001|TWO_SIDED|95.0|33.0228|64.6264|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||64.6264|33.0228|<0.0001
70880213|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.5395|||<|0.0001|TWO_SIDED|95.0|30.5968|62.4823|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||62.4823|30.5968|<0.0001
70880214|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|57.5565|||<|0.0001|TWO_SIDED|95.0|42.0679|73.0451|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||73.0451|42.0679|<0.0001
70880215|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.9622|||<|0.0001|TWO_SIDED|95.0|38.3293|69.5952|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||69.5952|38.3293|<0.0001
70880216|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.6772|||<|0.0001|TWO_SIDED|95.0|35.866|67.4884|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||67.4884|35.8660|<0.0001
70880217|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.4454||||0.0003|TWO_SIDED|95.0|17.7051|57.1857|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||57.1857|17.7051|0.0003
70880218|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.6714|||<|0.0001|TWO_SIDED|95.0|22.2888|61.054|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||61.0540|22.2888|<0.0001
70880219|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.7583||||0.0744|TWO_SIDED|95.0|-37.2956|1.7789|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.7789|-37.2956|0.0744
70880220|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.5551||||0.3458|TWO_SIDED|95.0|-29.5573|10.4471|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||10.4471|-29.5573|0.3458
70880221|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.792||||0.9375|TWO_SIDED|95.0|-19.1777|20.7616|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||20.7616|-19.1777|0.9375
70880222|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-55.2037|||<|0.0001|TWO_SIDED|95.0|-74.8113|-35.5961|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-35.5961|-74.8113|<0.0001
70880223|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.0005|||<|0.0001|TWO_SIDED|95.0|-67.002|-26.9989|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-26.9989|-67.0020|<0.0001
70959989|NCT00427895|141424319|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.2|||||TWO_SIDED|95.0|2.04|4.97||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||4.97|2.04|
70880224|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.6534||||0.0004|TWO_SIDED|95.0|-56.7246|-16.5822|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-16.5822|-56.7246|0.0004
70880225|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-59.4297|||<|0.0001|TWO_SIDED|95.0|-78.5162|-40.3433|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-40.3433|-78.5162|<0.0001
70880226|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.2265|||<|0.0001|TWO_SIDED|95.0|-70.8131|-31.6399|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-31.6399|-70.8131|<0.0001
70880227|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.8794||||0.0001|TWO_SIDED|95.0|-60.4726|-21.2862|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-21.2862|-60.4726|0.0001
70880228|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.5197||||0.0102|TWO_SIDED|95.0|5.7096|41.3298|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||41.3298|5.7096|0.0102
70880229|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.7321||||0.0021|TWO_SIDED|95.0|10.3632|45.1011|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||45.1011|10.3632|0.0021
70880230|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7334||||0.5935|TWO_SIDED|95.0|-22.2807|12.814|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||12.8140|-22.2807|0.5935
70880231|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5486||||0.6945|TWO_SIDED|95.0|-14.3397|21.437|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||21.4370|-14.3397|0.6945
70959990|NCT00427895|141424319|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.5|||||TWO_SIDED|95.0|1.5|4.0||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||4.00|1.50|
70959991|NCT00427895|141424319|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.7|||||TWO_SIDED|95.0|2.76|7.99||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||7.99|2.76|
70959992|NCT00427895|141424319|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.7|||||TWO_SIDED|95.0|0.93|2.97||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.97|0.93|
70880232|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.2936||||0.4177|TWO_SIDED|95.0|-10.4975|25.0847|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||25.0847|-10.4975|0.4177
70959993|NCT00427895|141424319|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.5|||||TWO_SIDED|95.0|0.99|2.39||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.39|0.99|
70959994|NCT00427895|141424319|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.2|||||TWO_SIDED|95.0|1.37|3.5||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||3.50|1.37|
70959995|NCT00427895|141424319|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.6|||||TWO_SIDED|95.0|1.78|3.68||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||3.68|1.78|
70880233|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.2531||||0.0019|TWO_SIDED|95.0|-45.802|-10.7042|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-10.7042|-45.8020|0.0019
70880234|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.9711||||0.0299|TWO_SIDED|95.0|-37.9541|-1.988|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-1.9880|-37.9541|0.0299
70880235|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2261||||0.0759|TWO_SIDED|95.0|-34.1785|1.7264|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.7264|-34.1785|0.0759
70880236|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.4655||||0.0002|TWO_SIDED|95.0|-49.2278|-15.7032|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-15.7032|-49.2278|0.0002
70959996|NCT00427895|141424319|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.7|||||TWO_SIDED|95.0|1.77|4.01||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||4.01|1.77|
70880237|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.1835||||0.0069|TWO_SIDED|95.0|-41.5832|-6.7838|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-6.7838|-41.5832|0.0069
70880238|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.4385||||0.0222|TWO_SIDED|95.0|-37.8861|-2.991|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-2.9910|-37.8861|0.0222
70880239|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.589||||0.0002|TWO_SIDED|95.0|12.0126|37.1654|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||37.1654|12.0126|0.0002
70880240|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.11|||<|0.0001|TWO_SIDED|95.0|16.4903|41.7298|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||41.7298|16.4903|<0.0001
70880241|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6428||||0.6809|TWO_SIDED|95.0|-10.0309|15.3165|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||15.3165|-10.0309|0.6809
70880242|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3215||||0.6067|TWO_SIDED|95.0|-16.0415|9.3985|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||9.3985|-16.0415|0.6067
70880243|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4722||||0.3999|TWO_SIDED|95.0|-7.335|18.2795|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||18.2795|-7.3350|0.3999
70880244|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.9461||||0.0007|TWO_SIDED|95.0|-34.5327|-9.3596|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-9.3596|-34.5327|0.0007
70880245|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.9105|||<|0.0001|TWO_SIDED|95.0|-40.564|-15.257|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-15.2570|-40.5640|<0.0001
70880246|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.1168||||0.0036|TWO_SIDED|95.0|-31.8907|-6.3428|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-6.3428|-31.8907|0.0036
70880247|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.4672|||<|0.0001|TWO_SIDED|95.0|-38.8298|-14.1046|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-14.1046|-38.8298|<0.0001
70880248|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.4315|||<|0.0001|TWO_SIDED|95.0|-44.925|-19.938|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-19.9380|-44.9250|<0.0001
70959997|NCT00427895|141424319|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.5|||||TWO_SIDED|95.0|1.99|6.13||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||6.13|1.99|
70959998|NCT00427895|141424319|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.2|||||TWO_SIDED|95.0|2.87|6.08||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||6.08|2.87|
70959999|NCT00427895|141424319|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.1|||||TWO_SIDED|95.0|2.26|4.3||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||4.30|2.26|
70960000|NCT00427895|141424319|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT ratio|2.6|||||TWO_SIDED|95.0|1.72|3.8||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||3.80|1.72|
70960001|NCT00427895|141424319|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|6.5|||||TWO_SIDED|95.0|4.09|10.19||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||10.19|4.09|
70960002|NCT00427895|141424319|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.9|||||TWO_SIDED|95.0|1.83|4.63||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||4.63|1.83|
70880249|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.6378||||0.0003|TWO_SIDED|95.0|-36.2802|-10.9954|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-10.9954|-36.2802|0.0003
70960003|NCT00427895|141424319|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.8|||||TWO_SIDED|95.0|2.41|6.03||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||6.03|2.41|
70880250|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6675||||0.9728|TWO_SIDED|95.0|-39.708|41.043|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||41.0430|-39.7080|0.9728
70880251|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.7977||||0.0246|TWO_SIDED|95.0|6.1059|79.4894|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||79.4894|6.1059|0.0246
70880252|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.5411||||0.7068|TWO_SIDED|95.0|-33.785|48.8672|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||48.8672|-33.7850|0.7068
70880253|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.7069||||0.5492|TWO_SIDED|95.0|-26.0358|47.4496|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||47.4496|-26.0358|0.5492
70880254|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.1248||||0.5899|TWO_SIDED|95.0|-31.3098|53.5595|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||53.5595|-31.3098|0.5899
70880255|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8736||||0.6998|TWO_SIDED|95.0|-29.8691|43.6163|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||43.6163|-29.8691|0.6998
70880256|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0394||||0.6187|TWO_SIDED|95.0|-31.4818|51.5606|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||51.5606|-31.4818|0.6187
70880257|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.4573||||0.5863|TWO_SIDED|95.0|-29.0355|49.9502|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||49.9502|-29.0355|0.5863
70880258|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.2566||||0.0832|TWO_SIDED|95.0|-75.608|5.0948|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.0948|-75.6080|0.0832
70880259|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.0907||||0.0827|TWO_SIDED|95.0|-68.7519|4.5704|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.5704|-68.7519|0.0827
70880260|NCT00975481|141245415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.6728||||0.1386|TWO_SIDED|95.0|-74.5352|11.1895|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||11.1895|-74.5352|0.1386
70880261|NCT00975481|141245416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3637||||0.1691|TWO_SIDED|95.0|-0.1566|0.884|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.8840|-0.1566|0.1691
70880262|NCT00975481|141245416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8444||||0.0017|TWO_SIDED|95.0|0.3238|1.365|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.3650|0.3238|0.0017
70880263|NCT00975481|141245416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2093||||0.4305|TWO_SIDED|95.0|-0.3141|0.7327|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.7327|-0.3141|0.4305
70960004|NCT00427895|141424319|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|5.8|||||TWO_SIDED|95.0|3.13|10.82||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||10.82|3.13|
70960005|NCT00427895|141424319|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.9|||||TWO_SIDED|95.0|1.3|2.84||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.84|1.30|
70880264|NCT00975481|141245416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1206||||0.6517|TWO_SIDED|95.0|-0.4064|0.6476|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.6476|-0.4064|0.6517
70880265|NCT00975481|141245416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0374||||0.8892|TWO_SIDED|95.0|-0.5666|0.4919|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.4919|-0.5666|0.8892
70880266|NCT00975481|141245416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1544||||0.5576|TWO_SIDED|95.0|-0.6737|0.3649|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.3649|-0.6737|0.5576
70880267|NCT00975481|141245416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2431||||0.3594|TWO_SIDED|95.0|-0.7658|0.2796|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.2796|-0.7658|0.3594
70880268|NCT00975481|141245416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4011||||0.1355|TWO_SIDED|95.0|-0.9291|0.127|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.1270|-0.9291|0.1355
70880269|NCT00975481|141245416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6351||||0.0153|TWO_SIDED|95.0|-1.1466|-0.1236|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-0.1236|-1.1466|0.0153
70880270|NCT00975481|141245416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7238||||0.0065|TWO_SIDED|95.0|-1.2418|-0.2059|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-0.2059|-1.2418|0.0065
70880271|NCT00975481|141245416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8818||||0.0011|TWO_SIDED|95.0|-1.4042|-0.3594|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-0.3594|-1.4042|0.0011
70880272|NCT00975481|141245416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1614|||<|0.0001|TWO_SIDED|95.0|-2.9373|-1.3856|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-1.3856|-2.9373|<0.0001
70880273|NCT00975481|141245416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0336|||<|0.0001|TWO_SIDED|95.0|-3.8085|-2.2587|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-2.2587|-3.8085|<0.0001
70880274|NCT00975481|141245416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2791||||0.4804|TWO_SIDED|95.0|-1.0586|0.5004|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.5004|-1.0586|0.4804
70880275|NCT00975481|141245416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024||||0.9519|TWO_SIDED|95.0|-0.7608|0.8087|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.8087|-0.7608|0.9519
70880276|NCT00975481|141245416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.497||||0.2152|TWO_SIDED|95.0|-1.286|0.2921|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.2921|-1.2860|0.2152
70880277|NCT00975481|141245416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8824|||<|0.0001|TWO_SIDED|95.0|1.1094|2.6553|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||2.6553|1.1094|<0.0001
70960006|NCT00427895|141424319|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.1|||||TWO_SIDED|95.0|2.02|4.78||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||4.78|2.02|
70960007|NCT00427895|141424319|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.7|||||TWO_SIDED|95.0|1.87|3.76||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||3.76|1.87|
70960008|NCT00427895|141424319|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.4|||||TWO_SIDED|95.0|2.97|6.58||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||6.58|2.97|
70960009|NCT00427895|141424319|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|5.5|||||TWO_SIDED|95.0|3.2|9.41||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||9.41|3.20|
70960010|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|6.5|||||TWO_SIDED|95.0|1.9|11.2||||||Serotype 1: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||11.2|1.9|
70960011|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.9|||||TWO_SIDED|95.0|-0.3|8.1||||||Serotype 3: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||8.1|-0.3|
70960012|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.4|||||TWO_SIDED|95.0|-0.2|7.2||||||Serotype 4: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||7.2|-0.2|
70960013|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|2.3|||||TWO_SIDED|95.0|-2.6|7.2||||||Serotype 5: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||7.2|-2.6|
70960014|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|26.6|||||TWO_SIDED|95.0|21.7|31.7||||||Serotype 6A: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||31.7|21.7|
70960015|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|7.5|||||TWO_SIDED|95.0|3.2|12.0||||||Serotype 6B: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||12.0|3.2|
70960016|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|12.3|||||TWO_SIDED|95.0|7.3|17.4||||||Serotype 7F: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||17.4|7.3|
70960017|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|14.1|||||TWO_SIDED|95.0|8.7|19.5||||||Serotype 9V: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||19.5|8.7|
70960018|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|-0.9|||||TWO_SIDED|95.0|-5.6|3.8||||||Serotype 14: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||3.8|-5.6|
70960019|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|6.5|||||TWO_SIDED|95.0|2.6|10.5||||||Serotype 18C: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||10.5|2.6|
70960020|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|4.1|||||TWO_SIDED|95.0|1.2|7.1||||||Serotype 19A: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||7.1|1.2|
70960021|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|Difference in Percentage|-1.2|||||TWO_SIDED|95.0|-5.5|3.2||||||Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.||3.2|-5.5|
70960022|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|23.2|||||TWO_SIDED|95.0|17.0|29.3||||||Serotype 23F: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||29.3|17.0|
70960023|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.6|||||TWO_SIDED|95.0|-0.2|7.5||||||Serotype 1: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||7.5|-0.2|
70960024|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|0.2|||||TWO_SIDED|95.0|-3.6|4.1||||||Serotype 3: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||4.1|-3.6|
70960025|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|2.4|||||TWO_SIDED|95.0|-0.4|5.5||||||Serotype 4: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||5.5|-0.4|
70960026|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|-0.9|||||TWO_SIDED|95.0|-5.8|3.9||||||Serotype 5: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||3.9|-5.8|
70960027|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|2.2|||||TWO_SIDED|95.0|-0.4|4.8||||||Serotype 6A: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||4.8|-0.4|
70960028|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|4.0|||||TWO_SIDED|95.0|0.8|7.2||||||Serotype 6B: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||7.2|0.8|
70960029|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|4.4|||||TWO_SIDED|95.0|0.6|8.2||||||Serotype 7F: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||8.2|0.6|
70960030|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.8|||||TWO_SIDED|95.0|-0.3|7.9||||||Serotype 9V: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||7.9|-0.3|
70960031|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Perecentage|4.2|||||TWO_SIDED|95.0|-0.1|8.7||||||Serotype 14: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||8.7|-0.1|
70960032|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|-0.6|||||TWO_SIDED|95.0|-3.8|2.5||||||Serotype 18C: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||2.5|-3.8|
70960033|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|-0.1|||||TWO_SIDED|95.0|-2.1|1.9||||||Serotype 19A: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||1.9|-2.1|
70960034|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|1.9|||||TWO_SIDED|95.0|-2.4|6.2||||||Serotype 19F: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||6.2|-2.4|
70960035|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|0.5|||||TWO_SIDED|95.0|-4.7|5.7||||||Serotype 23F: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||5.7|-4.7|
70960036|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|7.2|||||TWO_SIDED|95.0|4.3|10.6||||||Serotype 1: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||10.6|4.3|
70960037|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|2.6|||||TWO_SIDED|95.0|-0.3|5.9||||||Serotype 3: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||5.9|-0.3|
70960038|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|4.2|||||TWO_SIDED|95.0|2.1|6.9||||||Serotype 4: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||6.9|2.1|
70960039|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|5.1|||||TWO_SIDED|95.0|1.4|9.1||||||Serotype 5: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||9.1|1.4|
70960040|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.7|||||TWO_SIDED|95.0|1.7|6.1||||||Serotype 6A: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||6.1|1.7|
70960041|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|6.4|||||TWO_SIDED|95.0|4.1|9.3||||||Serotype 6B: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||9.3|4.1|
70960042|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|8.2|||||TWO_SIDED|95.0|5.4|11.6||||||Serotype 7F: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||11.6|5.4|
70880278|NCT00975481|141245416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1854|||<|0.0001|TWO_SIDED|95.0|1.407|2.9638|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||2.9638|1.4070|<0.0001
70960043|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|7.8|||||TWO_SIDED|95.0|4.8|11.4||||||Serotype 9V: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||11.4|4.8|
70960044|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|11.2|||||TWO_SIDED|95.0|8.0|14.9||||||Serotype 14: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||14.9|8.0|
70960045|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.1|||||TWO_SIDED|95.0|0.9|5.7||||||Serotype 18C: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||5.7|0.9|
70960046|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|1.4|||||TWO_SIDED|95.0|0.3|3.1||||||Serotype 19A: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||3.1|0.3|
70960047|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|8.4|||||TWO_SIDED|95.0|5.4|12.0||||||Serotype 19F: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||12.0|5.4|
70960048|NCT00427895|141424320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|10.5|||||TWO_SIDED|95.0|6.8|14.7||||||Serotype 23F: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||14.7|6.8|
70960049|NCT00427895|141424322|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.31|||||TWO_SIDED|95.0|1.52|3.51||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||3.51|1.52|
70960050|NCT00427895|141424322|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.37|||||TWO_SIDED|95.0|0.95|1.99||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||1.99|0.95|
70960051|NCT00427895|141424322|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.32|||||TWO_SIDED|95.0|1.47|3.64||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||3.64|1.47|
70960052|NCT00427895|141424322|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.4|||||TWO_SIDED|95.0|0.92|2.12||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.12|0.92|
70960053|NCT00427895|141424322|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.47|||||TWO_SIDED|95.0|1.01|2.16||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.16|1.01|
70960054|NCT00427895|141424322|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.03|||||TWO_SIDED|95.0|0.67|1.59||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||1.59|0.67|
70960055|NCT00427895|141424322|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.34|||||TWO_SIDED|95.0|0.94|1.92||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||1.92|0.94|
70960056|NCT00427895|141424322|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.33|||||TWO_SIDED|95.0|0.8|2.23||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.23|0.80|
70880279|NCT00975481|141245416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6645|||<|0.0001|TWO_SIDED|95.0|0.8786|2.4503|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||2.4503|0.8786|<0.0001
70880280|NCT00975481|141245416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7545|||<|0.0001|TWO_SIDED|95.0|1.9912|3.5179|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.5179|1.9912|<0.0001
70880281|NCT00975481|141245416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0576|||<|0.0001|TWO_SIDED|95.0|2.2858|3.8294|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.8294|2.2858|<0.0001
70880282|NCT00975481|141245416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5366|||<|0.0001|TWO_SIDED|95.0|1.7578|3.3155|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.3155|1.7578|<0.0001
70880283|NCT01826487|141245434|OTHER||Mean Difference (Final Values)|12.98|STANDARD_ERROR_OF_MEAN|10.415||0.213|TWO_SIDED|95.0|-7.44|33.39||Threshold for significance at 0.05. Secondary endpoints were tested for significance, only if the primary endpoint was statistically significant.|Mixed Models Analysis|||Analysis was performed using analysis of covariance (ANCOVA) method including stratification factors for age (less than \[\<\] 9 years versus \[vs.\] greater than or equal to \[\>=\] 9 years), duration of use of corticosteroids at baseline (approx. \>=6 to \<12 months vs. \>=12 months), and baseline 6MWD category (\>=350 meters vs \<350 meters), as well as baseline 6MWD as covariate.||33.39|-7.44|0.213
70880284|NCT01408030|141245445|OTHER|Two sided testing was performed with a significance level of 0.05.||||||0.97|||||||ANOVA|||||||0.97
70880285|NCT01408030|141245446|OTHER|Two sided testing was performed with a significance level of 0.05.||||||0.47|||||||ANOVA|||||||.47
70880286|NCT01408030|141245447|OTHER|Two sided testing was performed with a significance level of 0.05.|||||<|0.001||||||"A mixed-model repeated-measures ANOVA was used to analyze ESS for drug and time (baseline, week 12) effects.~Listed P value is for time effect."|Mixed Models Analysis|Clinical site and patient were included in the model as random effects.||||||<0.001
70880287|NCT01408030|141245448|OTHER|Two sided testing was performed with a significance level of 0.05.||||||0.43|||||||ANCOVA|Adjusted for baseline values and random effect of clinic site.||||||0.43
70880288|NCT01408030|141245449|OTHER|Two sided testing was performed with a significance level of 0.05.||||||0.42|||||||Fisher Exact|||||||0.42
70880289|NCT01408030|141245450|OTHER|Two sided testing was performed with a significance level of 0.05.||||||0.08|||||||Fisher Exact|||||||0.08
70880290|NCT00944450|141245467|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified equivalence bounds = (0.80, 1.25) for AUC geometric mean ratio (B/A)|Geometric Mean Ratio|1.05||||||90.0|1.02|1.07||||||100 mg MK0431 monohydrate (Phase III/FMI formulation) (B) vs. 100 mg MK0431 anhydrous (Phase IIB formulation) (A)||1.07|1.02|
70880291|NCT00944450|141245468|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified equivalence bounds = (0.80, 1.25) for Cmax geometric mean ratio (B/A)|Geometric Mean Ratio|1.07||||||90.0|0.94|1.22||||||100 mg MK0431 monohydrate (Phase III/FMI formulation) (B) vs. 100 mg MK0431 anhydrous (Phase IIB formulation) (A)||1.22|0.94|
70880292|NCT01831154|141245477|SUPERIORITY_OR_OTHER|||||||0.512|||||||Chi-squared|Chi-squared value of 1.34 and Cramer's V .190||Cross tabulation with statistical testing with chi-square and Cramer's V was performed on infection to determine if there was any difference in surgical site infections between the interventional groups in 30 day period.||||0.512
70880293|NCT01831154|141245478|SUPERIORITY_OR_OTHER|||||||0.024|||||||ANOVA|||||||0.024
70880294|NCT01831154|141245480|SUPERIORITY_OR_OTHER|||||||0.132|||||||ANOVA|||||||0.132
70880295|NCT01831154|141245481|SUPERIORITY_OR_OTHER|||||||0.908||||||A one way ANOVA was used to determine if participants in the tight glycemic group had shorter intensive care unit (ICU) length of stay (LOS) than participants in the other interventional groups.|ANOVA|||||||0.908
70880296|NCT03886220|141245490|SUPERIORITY||Odds Ratio (OR)|3.22||||0.035|TWO_SIDED|95.0|1.086|9.546||P-value for test of difference between elagolix dose group and placebo is by pooling the results from a logistic regression model including treatment as the main effect and baseline MBL volume as a covariate in each dataset from multiple imputation.|Regression, Logistic|||||9.546|1.086|0.035
70880297|NCT00768300|141245491|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.74||||0.01|TWO_SIDED|95.0|1.14|2.66||P-value was based on a stratified log-rank test with strata of baseline presence of pulmonary hypertension and whether a surgical lung biopsy was performed with definite or probable usual interstitial pneumonia (UIP) based on core pathology review.|Log Rank||The hazard ratio was based on a stratified Cox proportional hazards model with strata of baseline presence of pulmonary hypertension and whether a surgical lung biopsy was performed with definite or probable UIP based on core pathology review.|||2.66|1.14|0.010
70880298|NCT00768300|141245493|SUPERIORITY_OR_OTHER||Point estimate|4.29||||0.086|TWO_SIDED|95.0|-0.805|9.376||P-value was calculated using the Van Elteren test with strata of baseline presence of PH and whether a SLB was performed with definite or probable UIP based on core pathology review.|Van Elteren test||The point estimate and 95% confidence interval (CI) were based on the Hodges-Lehmann Estimate of treatment effect for percent change from baseline.|||9.376|-0.805|0.086
70880299|NCT00768300|141245494|SUPERIORITY_OR_OTHER||Point estimate|2.85||||0.25|TWO_SIDED|95.0|-2.2|7.9||P-value was calculated using the Van Elteren test with strata of baseline presence of PH and whether a SLB was performed with definite or probable UIP based on core pathology review.|Van Elteren test||The point estimate and its 95% CI were based on the Hodges-Lehmann Estimate of treatment effect for percent change from baseline.|||7.90|-2.20|0.250
70880300|NCT00768300|141245495|SUPERIORITY_OR_OTHER||Point estimate|16.0||||0.15|TWO_SIDED|95.0|-5.0|37.0||P-value was calculated using the Van Elteren test with strata of baseline presence of PH and whether a SLB was performed with definite or probable UIP based on core pathology review.|Van Elteren test||The point estimate and 95% CI were based on the Hodges-Lehmann Estimate of treatment effect for percent change from baseline.|||37.00|-5.00|0.150
70880301|NCT00768300|141245498|SUPERIORITY_OR_OTHER||Point estimate|0.5||||0.793|TWO_SIDED|95.0|0.0|1.0||The p-value was based on a Wilcoxon rank sum test stratified by baseline pulmonary hypertension (Yes/No) and surgical lung biopsy was performed with definite or probable UIP based on core pathology review (Yes/No).|Wilcoxon (Mann-Whitney)||The point estimate and 95% confidence interval were based on the Hodges-Lehmann Estimate of treatment effect|||1.00|0.00|0.793
70880302|NCT02448654|141245509|SUPERIORITY|||||||0.18||||||The a priori threshold for statistical significance was p\<0.05.|ANOVA|||||||0.18
70880303|NCT02448654|141245510|SUPERIORITY|||||||0.03||||||The a priori threshold for statistical significance was p\<0.05.|ANOVA|||||||0.03
70880304|NCT02448654|141245511|SUPERIORITY|||||||0.037||||||The a priori threshold for statistical significance was p\<0.05.|ANOVA|||||||0.037
70880305|NCT00449644|141245535|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|11.77||||0.0034|TWO_SIDED|95.0|2.26|61.23|||Cox proportional hazards model|Treatment, lung cavitation and pooled center were used as covaritates.||||61.23|2.26|0.0034
70880306|NCT00449644|141245536|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.44|||<|0.0001|TWO_SIDED|95.0|1.57|3.8|||Cox proportional hazards model|Treatment, lung cavitation and pooled center were used as covaritates.||||3.80|1.57|<0.0001
70880307|NCT00449644|141245537|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.14||||0.0022|TWO_SIDED|95.0|1.51|6.53|||Cox-proportional hazards model|Treatment, lung cavitation and pooled center were used as covaritates.||||6.53|1.51|0.0022
70880308|NCT00449644|141245538|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.029|TWO_SIDED|95.0|1.05|2.59|||Cox proportional hazards model|Treatment, lung cavitation and pooled center were used as covaritates.||MGIT negative (Responders)||2.59|1.05|0.0290
70880309|NCT00449644|141245539|SUPERIORITY_OR_OTHER||Risk Difference (RD)|38.9|STANDARD_ERROR_OF_MEAN|12.38||0.003|TWO_SIDED|95.0|13.97|63.88|||Regression, Logistic|Treatment as covariate||Week 8||63.88|13.97|0.003
70880310|NCT00449644|141245539|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.7|STANDARD_ERROR_OF_MEAN|13.12||0.237|TWO_SIDED|95.0|-10.7|42.17|||Regression, Logistic|Treatment as covariate||Week 24||42.17|-10.70|0.237
70880311|NCT00449644|141245539|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.9|STANDARD_ERROR_OF_MEAN|15.02||0.5564|TWO_SIDED|95.0|-21.37|39.18|||Regression, Logistic|Treatment as covariate||Week 104 (Stage 1 Trial End)||39.18|-21.37|0.5564
70880312|NCT00449644|141245540|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.2|STANDARD_ERROR_OF_MEAN|7.9||0.008|TWO_SIDED|95.0|5.59|36.83|||Regression, Logistic|Treatment as covariate||Week 24||36.83|5.59|0.008
70880313|NCT00449644|141245540|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.2|STANDARD_ERROR_OF_MEAN|8.27||0.069|TWO_SIDED|95.0|-1.21|31.51|||Regression, Logistic|Treatment as covariate||Week 72||31.51|-1.21|0.069
70880314|NCT00449644|141245540|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.2|STANDARD_ERROR_OF_MEAN|8.54||0.035|TWO_SIDED|95.0|1.28|35.08|||Regression, Logistic|Treatment as covariate||Week 120||35.08|1.28|0.035
70880315|NCT03642717|141245546|OTHER||||||<|0.0001||||||Paired t-test was applied comparing the difference in mean of change in Glycosylated hemoglobin (HbA1c) at Last Visit versus at Baseline.|Paired t-test|||||||< 0.0001
70880316|NCT03642717|141245549|OTHER||||||<|0.0001||||||Paired t-test was applied comparing the difference in mean of change in Fasting Plasma Glucose (FPG) at Last Visit versus at Baseline.|Paired t-test|||||||< 0.0001
70880317|NCT03642717|141245550|OTHER||||||<|0.0001||||||Paired t-test was applied comparing the difference in mean of change in body weight at Last Visit versus at Baseline.|Paired t-test|||||||< 0.0001
70880318|NCT03642717|141245551|OTHER|||||||0.0076||||||Paired t-test was applied comparing the difference in mean of change in systolic blood pressure (SBP) at Last Visit versus at Baseline.|Paired t-test|||||||0.0076
70880319|NCT03642717|141245552|OTHER||||||<|0.0001||||||Paired t-test was applied comparing the difference in mean of change in diastolic blood pressure (DBP) at Last Visit versus at Baseline.|Paired t-test|||||||< 0.0001
70880320|NCT01559012|141245555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2|STANDARD_DEVIATION|2.7||0.001|TWO_SIDED|95.0|1.05|3.32||A sample size modeling (MGH Mallinckrodt General Clinical Research Center) showed that a total of 12 patients were needed in order to detect a difference of 2 points of PUQE score between the two groups at P \< 0.01 and a beta \> 0.90.|Wilcoxon (Mann-Whitney)|Statistical signiﬁcance was assessed by the use of Mann-Whitney U test. P \< 0.05 was deﬁned as statistically signiﬁcant||This is an analysis between groups of intervention clonidine versus placebo. Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P \< 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean + SD.||3.32|1.05|0.001
70880321|NCT01559012|141245555|NON_INFERIORITY_OR_EQUIVALENCE|A sample size modeling (MGH Mallinckrodt General Clinical Research Center) showed that a total of 12 patients were needed in order to detect a difference of 2 points of PUQE score between the two groups at P \< 0.01|within patient variation|1.83|||<|0.02|TWO_SIDED|95.0|0.43|3.24|||Wilcoxon (Mann-Whitney)|||This is a within patient variation between clonidine and placebo. Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P \< 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean +/- Standard Deviation (SD).||3.24|0.43|<0.02
70880322|NCT01559012|141245556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0||||0.009|TWO_SIDED|95.0|1.78|11.5|||Wilcoxon (Mann-Whitney)|||Analysis within groups clonidine versus placebo. Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P \< 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean + SD. .||11.5|1.78|0.009
70880323|NCT01559012|141245556|NON_INFERIORITY_OR_EQUIVALENCE|A sample size modeling for crossover studies (MGH Mallinckrodt General Clinical Research Center) showed that a total of 12 patients were needed in order to detect a difference of 2 points of PUQE score between the two groups at P \< 0.01|within patient variation|7.5|||<|0.01|TWO_SIDED|95.0|2.17|12.83|||Wilcoxon (Mann-Whitney)|||Analysis within-patient. Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P \< 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean + SD.||12.83|2.17|<0.01
70880324|NCT01559012|141245557|SUPERIORITY_OR_OTHER||difference of percentage of positivity|0.3||||0|TWO_SIDED|95.0|0.04|0.47|||Wilcoxon (Mann-Whitney)|||"All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round~Allocation order randomized"||0.47|0.04|0.000
70880325|NCT01559012|141245558|SUPERIORITY_OR_OTHER||mean values|0.8||||0.013|TWO_SIDED|95.0|0.13|1.57|||Wilcoxon (Mann-Whitney)|||Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P \< 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean + SD. .||1.57|0.13|0.013
70880326|NCT01559012|141245559|SUPERIORITY_OR_OTHER||days off-therapy %|29.0||||0.051|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P \< 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean + SD. .||||0.051
70880327|NCT01559012|141245560|SUPERIORITY_OR_OTHER||proportion|0.0||||0.0089|TWO_SIDED|95.0|||||Fisher Exact|||||||0.0089
70880328|NCT01559012|141245563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0||||0.01|TWO_SIDED|95.0|0.9|10.9|||Wilcoxon (Mann-Whitney)|||||10.9|0.9|0.01
70880329|NCT01559012|141245564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||0.055|TWO_SIDED|95.0|0.3|6.3|||Wilcoxon (Mann-Whitney)|||||6.3|0.3|0.055
70880330|NCT00946712|141245565|OTHER||Hazard Ratio (HR)|0.93||||0.22|TWO_SIDED|95.0|0.83|1.04|||Log Rank|A stratified log rank test was used.||||1.04|0.83|0.22
70880331|NCT00946712|141245566|OTHER||Hazard Ratio (HR)|0.92||||0.4|TWO_SIDED|95.0|0.75|1.12|||Log Rank|A stratified log rank test was used.||||1.12|0.75|0.40
70880332|NCT00946712|141245567|OTHER||Hazard Ratio (HR)|0.81||||0.054|TWO_SIDED|95.0|0.66|1.0|||Log Rank|A stratified log rank test was used.||||1.00|0.66|0.054
70880333|NCT00946712|141245569|OTHER||Hazard Ratio (HR)|0.99||||0.83|TWO_SIDED|95.0|0.88|1.1|||Log Rank|A stratified log rank test was used.||||1.10|0.88|0.83
70880334|NCT00946712|141245571|OTHER|||||||0.48|||||||Cochran-Mantel-Haenszel|A stratified Cochran-Mantel-Haenszel test was conducted.||||||0.48
70880335|NCT00946712|141245572|OTHER|||||||0.06|||||||Cochran-Mantel-Haenszel|A stratified Cochran-Mantel-Haenszel test was conducted.||||||0.060
70880336|NCT04665050|141245575|OTHER|Estimated difference and confidence interval (CI) are calculated based on the Miettinen \& Nurminen method|Difference in percentage|0.0|||||TWO_SIDED|95.0|-12.7|12.7|||||V116 minus PNEUMOVAX™23|Injection Site Erythema||12.7|-12.7|
70880337|NCT04665050|141245575|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|-11.8|||||TWO_SIDED|95.0|-30.0|7.3|||||V116 minus PNEUMOVAX™23|Injection Site Pain||7.3|-30.0|
70880338|NCT04665050|141245575|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|0.0|||||TWO_SIDED|95.0|-14.1|14.1|||||V116 minus PNEUMOVAX™23|Injection Site Swelling||14.1|-14.1|
70880339|NCT04665050|141245576|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|3.9|||||TWO_SIDED|95.0|-9.4|17.5|||||V116 minus PNEUMOVAX™23|Fatigue||17.5|-9.4|
70880340|NCT04665050|141245576|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|0.0|||||TWO_SIDED|95.0|-9.9|9.9|||||V116 minus PNEUMOVAX™23|Arthralgia||9.9|-9.9|
70880341|NCT04665050|141245576|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|-2.0|||||TWO_SIDED|95.0|-17.5|13.6|||||V116 minus PNEUMOVAX™23|Myalgia||13.6|-17.5|
70880342|NCT04665050|141245576|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|0.0|||||TWO_SIDED|95.0|-12.7|12.7|||||V116 minus PNEUMOVAX™23|Headache||12.7|-12.7|
70880343|NCT04665050|141245577|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|0.0|||||TWO_SIDED|95.0|-7.1|7.1|||||V116 minus PNEUMOVAX™23|||7.1|-7.1|
70880344|NCT04665050|141245578|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|1.6|||||TWO_SIDED|95.0|1.07|2.4|||||V116/PNEUMOVAX™23|Serotype 3||2.40|1.07|
70880345|NCT04665050|141245578|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|1.21|||||TWO_SIDED|95.0|0.69|2.11|||||V116/PNEUMOVAX™23|Serotype 7F||2.11|0.69|
70880346|NCT04665050|141245578|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|2.0|||||TWO_SIDED|95.0|1.24|3.24|||||V116/PNEUMOVAX™23|Serotype 19A||3.24|1.24|
70880347|NCT04665050|141245578|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|1.92|||||TWO_SIDED|95.0|1.04|3.57|||||V116/PNEUMOVAX™23|Serotype 22F||3.57|1.04|
70880348|NCT04665050|141245578|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|1.15|||||TWO_SIDED|95.0|0.71|1.86|||||V116/PNEUMOVAX™23|Serotype 33F||1.86|0.71|
70880349|NCT04665050|141245578|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|1.78|||||TWO_SIDED|95.0|1.24|2.58|||||V116/PNEUMOVAX™23|Serotype 8||2.58|1.24|
70880350|NCT04665050|141245578|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|1.89|||||TWO_SIDED|95.0|1.19|3.0|||||V116/PNEUMOVAX™23|Serotype 9N||3.00|1.19|
70880351|NCT04665050|141245578|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|2.71|||||TWO_SIDED|95.0|1.47|5.0|||||V116/PNEUMOVAX™23|Serotype 10A||5.00|1.47|
70880352|NCT04665050|141245578|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|2.43|||||TWO_SIDED|95.0|1.52|3.89|||||V116/PNEUMOVAX™23|Serotype 11A||3.89|1.52|
70880353|NCT04665050|141245578|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|2.4|||||TWO_SIDED|95.0|1.2|4.83|||||V116/PNEUMOVAX™23|Serotype 12F||4.83|1.20|
70880354|NCT04665050|141245578|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|2.57|||||TWO_SIDED|95.0|1.59|4.17|||||V116/PNEUMOVAX™23|Serotype 17F||4.17|1.59|
70880355|NCT04665050|141245578|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|2.28|||||TWO_SIDED|95.0|1.46|3.56|||||V116/PNEUMOVAX™23|Serotype 20A||3.56|1.46|
70880356|NCT04665050|141245579|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.54|||||TWO_SIDED|95.0|1.08|2.21|||||V116/PNEUMOVAX™23|Serotype 3||2.21|1.08|
70880357|NCT04665050|141245579|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.21|||||TWO_SIDED|95.0|1.36|3.6|||||V116/PNEUMOVAX™23|Serotype 7F||3.60|1.36|
70880358|NCT04665050|141245579|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.16|||||TWO_SIDED|95.0|1.45|3.23|||||V116/PNEUMOVAX™23|Serotype 19A||3.23|1.45|
70880359|NCT04665050|141245579|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.33|||||TWO_SIDED|95.0|1.36|3.99|||||V116/PNEUMOVAX™23|Serotype 22F||3.99|1.36|
70880360|NCT04665050|141245579|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.52|||||TWO_SIDED|95.0|0.97|2.37|||||V116/PNEUMOVAX™23|Serotype 33F||2.37|0.97|
70880361|NCT04665050|141245579|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.88|||||TWO_SIDED|95.0|1.32|2.68|||||V116/PNEUMOVAX™23|Serotype 8||2.68|1.32|
70880362|NCT04665050|141245579|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.37|||||TWO_SIDED|95.0|1.49|3.74|||||V116/PNEUMOVAX™23|Serotype 9N||3.74|1.49|
70880363|NCT04665050|141245579|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.16|||||TWO_SIDED|95.0|1.28|3.65|||||V116/PNEUMOVAX™23|Serotype 10A||3.65|1.28|
70880364|NCT04665050|141245579|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.92|||||TWO_SIDED|95.0|1.28|2.89|||||V116/PNEUMOVAX™23|Serotype 11A||2.89|1.28|
70880365|NCT04665050|141245579|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|3.49|||||TWO_SIDED|95.0|1.94|6.27|||||V116/PNEUMOVAX™23|Serotype 12F||6.27|1.94|
70880366|NCT04665050|141245579|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.88|||||TWO_SIDED|95.0|1.92|4.31|||||V116/PNEUMOVAX™23|Serotype 17F||4.31|1.92|
70880367|NCT04665050|141245579|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.05|||||TWO_SIDED|95.0|1.3|3.25|||||V116/PNEUMOVAX™23|Serotype 20A||3.25|1.30|
70880368|NCT04665050|141245580|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|3.58|||||TWO_SIDED|95.0|1.86|6.88|||||V116/PNEUMOVAX™23|Serotype 6A||6.88|1.86|
70880369|NCT04665050|141245580|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|6.23|||||TWO_SIDED|95.0|3.54|10.98|||||V116/PNEUMOVAX™23|Serotype 15A||10.98|3.54|
70880370|NCT04665050|141245580|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|2.33|||||TWO_SIDED|95.0|1.23|4.39|||||V116/PNEUMOVAX™23|Serotype 15C||4.39|1.23|
70880371|NCT04665050|141245580|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|10.06|||||TWO_SIDED|95.0|5.39|18.78|||||V116/PNEUMOVAX™23|Serotype 16F||18.78|5.39|
70880372|NCT04665050|141245580|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|42.09|||||TWO_SIDED|95.0|19.67|90.03|||||V116/PNEUMOVAX™23|Serotype 23A||90.03|19.67|
70880373|NCT04665050|141245580|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|12.37|||||TWO_SIDED|95.0|6.97|21.94|||||V116/PNEUMOVAX™23|Serotype 23B||21.94|6.97|
70880374|NCT04665050|141245580|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|24.82|||||TWO_SIDED|95.0|11.65|52.86|||||V116/PNEUMOVAX™23|Serotype 24F||52.86|11.65|
70880375|NCT04665050|141245580|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|25.66|||||TWO_SIDED|95.0|14.65|44.93|||||V116/PNEUMOVAX™23|Serotype 31||44.93|14.65|
70880376|NCT04665050|141245580|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|14.3|||||TWO_SIDED|95.0|8.72|23.47|||||V116/PNEUMOVAX™23|Serotype 35B||23.47|8.72|
70880377|NCT04665050|141245581|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|3.0|||||TWO_SIDED|95.0|1.73|5.19|||||V116/PNEUMOVAX™23|Serotype 6A||5.19|1.73|
70880378|NCT04665050|141245581|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|8.03|||||TWO_SIDED|95.0|4.61|13.98|||||V116/PNEUMOVAX™23|Serotype 15A||13.98|4.61|
70880379|NCT04665050|141245581|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|3.14|||||TWO_SIDED|95.0|1.77|5.58|||||V116/PNEUMOVAX™23|Serotype 15C||5.58|1.77|
70880380|NCT04665050|141245581|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|13.06|||||TWO_SIDED|95.0|8.45|20.19|||||V116/PNEUMOVAX™23|Serotype 16F||20.19|8.45|
70880381|NCT04665050|141245581|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|8.55|||||TWO_SIDED|95.0|5.19|14.09|||||V116/PNEUMOVAX™23|Serotype 23A||14.09|5.19|
70880382|NCT04665050|141245581|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|4.15|||||TWO_SIDED|95.0|2.72|6.36|||||V116/PNEUMOVAX™23|Serotype 23B||6.36|2.72|
70880383|NCT04665050|141245581|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|28.68|||||TWO_SIDED|95.0|16.59|49.58|||||V116/PNEUMOVAX™23|Serotype 24F||49.58|16.59|
70880384|NCT04665050|141245581|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|10.27|||||TWO_SIDED|95.0|6.71|15.73|||||V116/PNEUMOVAX™23|Serotype 31||15.73|6.71|
70880385|NCT04665050|141245581|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|15.95|||||TWO_SIDED|95.0|11.62|21.9|||||V116/PNEUMOVAX™23|Serotype 35B||21.90|11.62|
70880386|NCT00853723|141245597|NON_INFERIORITY_OR_EQUIVALENCE|An equivalence test of means for the percentage change in PINP and CTX using two one-sided tests applied to data from the parallel group design with a sample size of 31 in the PTH(1-34) group and 62 in the combined PTHrP(1-36) group achieved 80% power at 2.5% significant level for two-sided hypothesis testing (adjusted for the hypothesis testing at two key endpoints).|||||<|0.0005|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline by day 15 in all three arms.|Kruskal-Wallis|||||||<0.0005
70880387|NCT00853723|141245598|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline in all Arms/groups.|Kruskal-Wallis|The threshold for stasistical significance was p=0.05||||||<0.05
70880388|NCT00853723|141245599|NON_INFERIORITY_OR_EQUIVALENCE|An equivalence test of means for the percentage change in PINP and CTX using two one-sided tests applied to data from the parallel group design with a sample size of 31 in the PTH(1-34) group and 62 in the combined PTHrP(1-36) group achieved 80% power at 2.5% significant level for two-sided hypothesis testing (adjusted for the hypothesis testing at two key endpoints).|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline at Day 60 and at Day 90 for the PTH group and at day 90 for the PTHrP 400 and PTHrP 600 groups .|Kruskal-Wallis|||||||<0.05
70880389|NCT00853723|141245600|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline in PTHrP 400 and 600 groups.|Kruskal-Wallis|The threshold for stastistical significance was p=0.05||||||<0.05
70880390|NCT00853723|141245601|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline in the PTHrP 400 group|Kruskal-Wallis|The threshold for stastistical significance was p=0.05||||||<0.05
70880391|NCT00853723|141245602|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline in all Arms/groups|Kruskal-Wallis|The threshold for statistical signifcance was p=0.05||||||>0.05
70880392|NCT00853723|141245603|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline in all Arms/groups|Kruskal-Wallis|The threshold for statistical significance was p=0.05||||||>0.05
70880393|NCT00853723|141245604|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.0005|TWO_SIDED|||||The reported p-value corresponds to change from baseline at Day 15 and 30 in the PTHrP 400 group and at Day 15 in the PTHrP 600 group|F-test, one way analysis of variance|The threshold for statistical significance was p=0.05||||||<0.0005
70880394|NCT00853723|141245605|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds to PTH group on Day 60 compared to the PTHrP 400|F-test, one way analysis of variance|The threshold for statistical significance was p=0.05||||||<0.05
70880395|NCT00853723|141245605|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.005|TWO_SIDED|||||The reported p-value corresponds to the PTH group on Day 30 compared to the PTHrP 400 group and Day 60 compared to the PTHRp 600 group|Kruskal-Wallis|The threshold for statistical significance was p=0.05||||||<0.005
70880396|NCT00853723|141245605|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.0005|TWO_SIDED|||||The reported p-value correspond to the PTH group on Day 15 compared to the PTHrP 400 group and Day 15 and 30 compared to the PTHrP 600 group.|Kruskal-Wallis|The threshold for statistical significance was p=0.05||||||<0.0005
70880397|NCT00853723|141245606|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.005|TWO_SIDED|||||The reported p-value corresponds to the increase from baseline to D90 in the PTHrP 400 group.|F-test, one way analysis of variance|the threshold for statistical significance was p=0.05||||||<0.005
70880398|NCT00853723|141245607|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05|TWO_SIDED|||||The reported p value corresponds to an increased from baseline at all time points in all Arms/groups as well as to the increase in the in the PTHrP 400 group at Day 60 and 90 compared to the PTHrP 600 and PTH groups .|F-test, one way analysis of variance|the threshold for statistical significance was p=0.05||||||<0.05
70880399|NCT00853723|141245607|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes|||||<|0.005|TWO_SIDED|||||The reported p-value corresponds to the comparison of the PTHrP 400 group at Day 15 to the PTHrP 600 and PTH groups|Kruskal-Wallis|The threshold for statistical significance was p=0.05||||||<0.005
70880400|NCT00853723|141245608|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate.|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds to an increase compared to baseline in the PTHrP 600 group at D15 and D30|F-test, one way analysis of variance|The threshold for stastistical significance was p=0.05||||||<0.05
70880401|NCT00853723|141245608|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate.|||||<|0.005|TWO_SIDED|||||the reported p-value corresponds to change from baseline in the PTHrP 400 group at Day 15,30, 60 and 90 and the PTH group at day 90.|Kruskal-Wallis|the threshold for statistical significance was p=0.05||||||<0.005
70880402|NCT00853723|141245609|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds the PTH group on Day 15 compared to the PTHrP 400 group and to the PTHrP 600 group at Day 30 and Day 60|Kruskal-Wallis|The threshold for statistical significance was p=0.05||||||<0.05
70880403|NCT00853723|141245609|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate.|||||<|0.0005|TWO_SIDED|||||Thre reported p-value correspond to the PTH group compared to the PTHrp 600 group at day 15|Kruskal-Wallis|the threshold for statistical significance was p=0.05||||||<0.0005
70880404|NCT01252940|141245636|NON_INFERIORITY_OR_EQUIVALENCE|A 95% confidence interval (CI) for the difference between treatment groups in the percentages of virologic success was constructed using normal approximation. Noninferiority was assessed using a conventional 95% CI approach, with a noninferiority margin of 12%. It would be concluded that the FTC/RPV/TDF STR group was not inferior to the SBR group if the lower bound of the 2-sided 95% CI of the difference (FTC/RPV/TDF STR - SBR) in the response rate was greater than -12%.|Mean Difference (Net)|3.8|||||TWO_SIDED|95.0|-1.6|9.1||||||||9.1|-1.6|
70960057|NCT00427895|141424322|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.04|||||TWO_SIDED|95.0|0.68|1.59||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||1.59|0.68|
70880405|NCT03759379|141245657|EQUIVALENCE|H0: No difference between vutrisiran and external placebo comparator (APOLLO): difference (vutrisiran - placebo) = 0|LS Mean Difference|-17.0|STANDARD_ERROR_OF_MEAN|2.44|<|1e-07|TWO_SIDED|95.0|-21.78|-12.22||P=3.542E-12|ANCOVA with Multiple Imputation|||Multiple imputation estimates and p-value derived per combining least squares (LS) estimates per Rubin's rules based on 100 datasets where missing Month 9 values were imputed using a regression procedure including select baseline variables. LS estimates derived from analysis of covariance model, controlling for categorical factors (treatment, genotype, age of disease onset) and continuous covariate (baseline value).||-12.22|-21.78|<0.0000001
70880406|NCT03759379|141245658|EQUIVALENCE|H0: No difference between vutrisiran and external placebo comparator (APOLLO): difference (vutrisiran - placebo) = 0|LS Mean Difference|-16.2|STANDARD_ERROR_OF_MEAN|2.8|<|1e-07|TWO_SIDED|95.0|-21.7|-10.8||P=5.426E-09|ANCOVA with Multiple Imputation|||Multiple imputation estimates and p-value derived per combining least squares (LS) estimates per Rubin's rules based on 100 datasets where missing Month 9 values were imputed using a regression procedure including select baseline variables. LS estimates derived from analysis of covariance model, controlling for categorical factors (treatment, genotype, age of disease onset baseline NIS) and continuous covariate (baseline value).||-10.8|-21.7|<0.0000001
70880407|NCT03759379|141245659|EQUIVALENCE|H0: No difference between vutrisiran and external placebo comparator (APOLLO): difference (vutrisiran - placebo) = 0|LS Mean Difference|0.131|STANDARD_ERROR_OF_MEAN|0.031|<|1e-07|TWO_SIDED|95.0|0.07|0.193||P=3.103E-05|ANCOVA with Multiple Imputation|||Multiple imputation estimates and p-value derived per combining least squares (LS) estimates per Rubin's rules based on 100 datasets where missing Month 9 values were imputed using a regression procedure including select baseline variables. LS estimates derived from analysis of covariance model, controlling for categorical factors (treatment, genotype, age of disease onset, baseline NIS) and continuous covariate (baseline value).||0.193|0.070|<0.0000001
70880408|NCT02436759|141245755|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Two-sided t-test with treatment as a fixed factor and baseline score as a covariate||||||<0.0001
70880409|NCT02436759|141245756|SUPERIORITY|||||||0.12|||||||ANCOVA|Two-sided t-test||||||0.12
70880410|NCT03054857|141245757|SUPERIORITY||Risk Ratio (RR)|1.532||||0.289|TWO_SIDED|95.0|0.689|3.406|||Chi-squared|||||3.406|0.689|0.289
70880411|NCT03054857|141245758|SUPERIORITY||Risk Ratio (RR)|1.329||||0.636|TWO_SIDED|95.0|0.409|4.319|||Chi-squared|||||4.319|0.409|0.636
70880412|NCT03054857|141245760|SUPERIORITY||Mean Difference (Final Values)|-1.053|STANDARD_DEVIATION|0.792||0.187|TWO_SIDED|95.0|-2.626|0.52|||t-test, 2 sided|||||0.52|-2.626|0.187
70880413|NCT03054857|141245761|SUPERIORITY||Mean Difference (Final Values)|-4.644|STANDARD_DEVIATION|7.606||0.543|TWO_SIDED|95.0|-19.74|10.45|||t-test, 2 sided|||||10.45|-19.74|0.543
70880414|NCT02666183|141245784|OTHER||Estimated marginal mean difference|-2.251||||0.162|TWO_SIDED|95.0|-5.051|0.55|||ANCOVA|Covariates: DCG age, gender, race, income||||0.550|-5.051|0.162
70880415|NCT02666183|141245784|OTHER||Estimated marginal mean difference|-3.663||||0.007|TWO_SIDED|95.0|-6.538|-0.789|||ANCOVA|Covariates: DCG age, gender, race, income||||-0.789|-6.538|0.007
70880416|NCT02666183|141245784|OTHER||Estimated marginal mean difference|-1.413||||0.714|TWO_SIDED|95.0|-4.29|1.464|||ANCOVA|Covariates: DCG age, gender, race, income||||1.464|-4.290|0.714
70880417|NCT02666183|141245785|OTHER||Estimated marginal mean difference|-0.531||||0.173|TWO_SIDED|95.0|-1.297|0.234|||ANCOVA|Covariates: DCG age, gender, race, income||||0.234|-1.297|0.173
70880418|NCT02666183|141245785|OTHER||Estimated marginal mean difference|-1.456||||0.001|TWO_SIDED|95.0|-2.241|-0.671|||ANCOVA|Covariates: DCG age, gender, race, income||||-0.671|-2.241|0.001
70880419|NCT02666183|141245785|OTHER||Estimated marginal mean difference|-0.925||||0.021|TWO_SIDED|95.0|-1.711|-0.139|||ANCOVA|Covariates: DCG age, gender, race, income||||-0.139|-1.711|0.021
70880420|NCT02666183|141245786|OTHER||Estimated marginal mean difference|-0.984||||0.323|TWO_SIDED|95.0|-2.939|0.971|||ANCOVA|Covariates: DCG age, gender, race, income||||0.971|-2.939|0.323
70880421|NCT02666183|141245786|OTHER||Estimated marginal mean difference|-1.768||||0.086|TWO_SIDED|95.0|-3.785|0.249|||ANCOVA|Covariates: DCG age, gender, race, income||||0.249|-3.785|0.086
70880422|NCT02666183|141245786|OTHER||Estimated marginal mean difference|-0.784||||0.443|TWO_SIDED|95.0|-2.794|1.226|||ANCOVA|Covariates: DCG age, gender, race, income||||1.226|-2.794|0.443
70880423|NCT03616912|141245787|SUPERIORITY||Odds Ratio (OR)|1.57||||0.016|TWO_SIDED|95.0|1.09|2.27|||Regression, Logistic|||||2.27|1.09|0.016
70880424|NCT03616912|141245788|SUPERIORITY||Odds Ratio (OR)|1.14||||0.47|TWO_SIDED|95.0|0.79|1.65|||Regression, Logistic|||||1.65|0.79|0.470
70880425|NCT03616912|141245789|SUPERIORITY||Odds Ratio (OR)|0.96||||0.839|TWO_SIDED|95.0|0.63|1.45|||Regression, Logistic|||||1.45|0.63|0.839
70880426|NCT03616912|141245789|SUPERIORITY||Odds Ratio (OR)|1.19||||0.391|TWO_SIDED|95.0|0.8|1.79|||Regression, Logistic|||||1.79|0.80|0.391
70880427|NCT03616912|141245791|SUPERIORITY||Odds Ratio (OR)|0.94||||0.82|TWO_SIDED|95.0|0.53|1.66|||Regression, Logistic|||||1.66|0.53|0.820
70880428|NCT03616912|141245791|SUPERIORITY||Odds Ratio (OR)|1.18||||0.565|TWO_SIDED|95.0|0.67|2.08|||Regression, Logistic|||||2.08|0.67|0.565
70880429|NCT03616912|141245792|SUPERIORITY||LS Mean Difference Final Values|-0.11|STANDARD_ERROR_OF_MEAN|0.21||0.598|TWO_SIDED|95.0|-0.52|0.3|||Mixed Models Analysis|||||0.30|-0.52|0.598
70880430|NCT03616912|141245792|SUPERIORITY||LS Mean Difference Final Values|-0.09|STANDARD_ERROR_OF_MEAN|0.21||0.674|TWO_SIDED|95.0|-0.5|0.32|||Mixed Models Analysis|||||0.32|-0.50|0.674
70880431|NCT03616912|141245793|SUPERIORITY||LS Mean Difference Final Values|0.02|STANDARD_ERROR_OF_MEAN|0.85||0.979|TWO_SIDED|95.0|-1.65|1.7|||Mixed Models Analysis|||||1.70|-1.65|0.979
70960058|NCT00427895|141424322|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.15|||||TWO_SIDED|95.0|0.8|1.66||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||1.66|0.80|
70960059|NCT00427895|141424322|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.79||||||95.0|1.07|3.0||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||3.00|1.07|
70960060|NCT00427895|141424322|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.45|||||TWO_SIDED|95.0|0.95|2.24||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.24|0.95|
70960061|NCT00427895|141424322|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.18|||||TWO_SIDED|95.0|1.53|3.12||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||3.12|1.53|
70960062|NCT00427895|141424322|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.42|||||TWO_SIDED|95.0|1.06|1.91||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||1.91|1.06|
70960063|NCT00427895|141424322|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.47|||||TWO_SIDED|95.0|1.71|3.55||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||3.55|1.71|
70960064|NCT00427895|141424322|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.99|||||TWO_SIDED|95.0|1.45|2.74||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.74|1.45|
70960065|NCT00427895|141424322|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.04|||||TWO_SIDED|95.0|1.5|2.76||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.76|1.50|
70960066|NCT00427895|141424322|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.85|||||TWO_SIDED|95.0|1.32|2.58||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.58|1.32|
70960067|NCT00427895|141424322|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.96|||||TWO_SIDED|95.0|1.46|2.62||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.62|1.46|
70960068|NCT00427895|141424322|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.96|||||TWO_SIDED|95.0|1.32|2.91||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.91|1.32|
70960069|NCT00427895|141424322|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.36|||||TWO_SIDED|95.0|0.94|1.97||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||1.97|0.94|
70960070|NCT00427895|141424322|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.48|||||TWO_SIDED|95.0|1.08|2.03||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.03|1.08|
70960071|NCT00427895|141424322|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|3.35|||||TWO_SIDED|95.0|2.19|5.12||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||5.12|2.19|
70880432|NCT03616912|141245793|SUPERIORITY||LS Mean Difference Final Values|-0.36|STANDARD_ERROR_OF_MEAN|0.86||0.678|TWO_SIDED|95.0|-2.03|1.32|||Mixed Models Analysis|||||1.32|-2.03|0.678
70960072|NCT00427895|141424322|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.0|||||TWO_SIDED|95.0|1.41|2.83||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.83|1.41|
70960073|NCT03373201|141424347|SUPERIORITY||Difference between LS means|60.3|||<|0.0001|TWO_SIDED|95.0|44.0|76.7|||ANOVA|||||76.7|44.0|<.0001
70960074|NCT03373201|141424348|SUPERIORITY||Difference between LS Means.|85.5|||<|0.0001|TWO_SIDED|95.0|64.3|106.6|||ANOVA|||||106.6|64.3|<.0001
70880433|NCT03616912|141245794|SUPERIORITY||Odds Ratio (OR)|1.02||||0.965|TWO_SIDED|95.0|0.43|2.42|||Regression, Logistic|||||2.42|0.43|0.965
70880434|NCT03616912|141245794|SUPERIORITY||Odds Ratio (OR)|1.22||||0.661|TWO_SIDED|95.0|0.51|2.92|||Regression, Logistic|||||2.92|0.51|0.661
70960075|NCT03373201|141424349|SUPERIORITY||Difference between LS means|-15.1|||<|0.0001|TWO_SIDED|95.0|-26.2|-4.0|||ANOVA|||||-4.0|-26.2|<.0001
70960076|NCT03373201|141424350|SUPERIORITY||Difference between LS means|-74.6|||<|0.0001|TWO_SIDED|95.0|-94.8|-54.3|||ANOVA|||||-54.3|-94.8|<.0001
70880435|NCT03616912|141245795|SUPERIORITY||LS Mean Difference Final Values|0.24|STANDARD_ERROR_OF_MEAN|0.43||0.578|TWO_SIDED|95.0|-0.61|1.08|||Mixed Models Analysis|||||1.08|-0.61|0.578
70880436|NCT03616912|141245795|SUPERIORITY||LS Mean Difference Final Values|-0.44|STANDARD_ERROR_OF_MEAN|0.433||0.309|TWO_SIDED|95.0|-1.29|0.41|||Mixed Models Analysis|||||0.41|-1.29|0.309
70880437|NCT03616912|141245796|SUPERIORITY||LS Mean Difference Final Values|-0.29|STANDARD_ERROR_OF_MEAN|0.277||0.287|TWO_SIDED|95.0|-0.84|0.25|||Mixed Models Analysis|||||0.25|-0.84|0.287
70880438|NCT03616912|141245796|SUPERIORITY||LS Mean Difference Final Values|-0.44|STANDARD_ERROR_OF_MEAN|0.278||0.113|TWO_SIDED|95.0|-0.99|0.11|||Mixed Models Analysis|||||0.11|-0.99|0.113
70880439|NCT02584504|141245799|SUPERIORITY||Least Square (LS) Mean Difference|-39.5|||<|0.0001|TWO_SIDED|97.5|-46.5|-32.4||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis|Threshold for significance at 0.025 level.|Alirocumab 150 mg Q4W vs. Placebo|Alirocumab 150 mg Q4W group was compared to placebo group using an appropriate contrast statement.||-32.4|-46.5|<0.0001
70880440|NCT02584504|141245799|SUPERIORITY||LS Mean Difference|-65.8|||<|0.0001|TWO_SIDED|97.5|-72.9|-58.7||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Alirocumab 150 mg Q2W group was compared to placebo group using an appropriate contrast statement.||-58.7|-72.9|<0.0001
70880441|NCT02584504|141245799|OTHER|Statistical test was not planned because this comparison was for a descriptive purpose.|LS Mean Difference|-26.3|||||TWO_SIDED|95.0|-32.5|-20.0|||||Alirocumab 150 mg Q4W group vs Alirocumab 150 mg Q2W|Alirocumab 150 mg Q4W group was compared to Alirocumab 150 mg Q2W group using an appropriate contrast statement.||-20.0|-32.5|
70880442|NCT02584504|141245800|SUPERIORITY||LS Mean Difference|-40.6|||<|0.0001|TWO_SIDED|97.5|-47.4|-33.8||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level. Hierarchical procedure for comparisons of Alirocumab 150 mg Q4W versus Placebo Q2W and Alirocumab 150 mg Q2W versus Placebo Q2W were processed separately.||-33.8|-47.4|<0.0001
70880443|NCT02584504|141245800|SUPERIORITY||LS Mean Difference|-67.4|||<|0.0001|TWO_SIDED|97.5|-74.2|-60.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-60.5|-74.2|<0.0001
70880444|NCT02584504|141245801|SUPERIORITY||LS Mean Difference|-50.5|||<|0.0001|TWO_SIDED|97.5|-56.6|-44.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-44.5|-56.6|<0.0001
70880445|NCT02584504|141245801|SUPERIORITY||LS Mean Difference|-66.2|||<|0.0001|TWO_SIDED|97.5|-72.3|-60.1||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-60.1|-72.3|<0.0001
70880446|NCT02584504|141245802|SUPERIORITY||LS Mean Difference|-51.4|||<|0.0001|TWO_SIDED|97.5|-57.4|-45.4||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-45.4|-57.4|<0.0001
70880447|NCT02584504|141245802|SUPERIORITY||LS Mean Difference|-67.3|||<|0.0001|TWO_SIDED|97.5|-73.3|-61.3||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-61.3|-73.3|<0.0001
70880448|NCT02584504|141245803|SUPERIORITY||LS Mean Difference|-26.2|||<|0.0001|TWO_SIDED|97.5|-32.5|-19.9||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-19.9|-32.5|<0.0001
70960077|NCT03373201|141424351|SUPERIORITY||Difference between LS Means.|-0.5||||0.0083|TWO_SIDED|95.0|-0.9|-0.1|||ANOVA|||||-0.1|-0.9|0.0083
70960078|NCT03373201|141424352|SUPERIORITY||Difference between LS Means.|6.6||||0.0099|TWO_SIDED|95.0|1.6|11.6|||ANOVA|||||11.6|1.6|0.0099
70960079|NCT05269355|141424370|OTHER||Hazard Ratio (HR)|0.61||||0.0017|TWO_SIDED|95.0|0.45|0.83|||Regression, Cox|||||0.83|0.45|0.0017
70880449|NCT02584504|141245803|SUPERIORITY||LS Mean Difference|-51.9|||<|0.0001|TWO_SIDED|97.5|-58.3|-45.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-45.5|-58.3|<0.0001
70880450|NCT02584504|141245804|SUPERIORITY||LS Mean Difference|-27.2|||<|0.0001|TWO_SIDED|97.5|-33.5|-20.9||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-20.9|-33.5|<0.0001
70960080|NCT00081497|141424376|SUPERIORITY_OR_OTHER||Change in Slope Mean|-0.029||||0.013||95.0|-0.051|-0.007|||Mixed Models Analysis|Mixed effects model with a population level (fixed effect) intercept and slope and a subject level (random effect) intercept and slope.||The statistical analysis represents the primary outcome measure results.||-0.007|-0.051|0.0130
70960081|NCT00081497|141424377|SUPERIORITY_OR_OTHER||Mean Difference|-6.787||||0.0027||95.0|-11.123|-2.45|||Mixed Effects Model|||Statistical Analysis 1 represents the post-hoc outcome results for difference in slope mean of eGFR subgroup \>60.||-2.450|-11.123|0.0027
70960082|NCT00081497|141424377|SUPERIORITY_OR_OTHER||Mean Difference|2.33||||0.1268||95.0|-0.685|5.345|||Mixed Effects Model|||Statistical Analysis 2 represents the post-hoc outcome results for difference in slope mean of eGFR subgroup ≤ 60.||5.345|-0.685|0.1268
70960083|NCT01786174|141424386|SUPERIORITY_OR_OTHER||Slope|1.4|STANDARD_ERROR_OF_MEAN|4.3||0.746|TWO_SIDED|95.0|-7.17|9.96|||Random slopes model|||Fingolimod vs. Placebo Weeks 0-4||9.96|-7.17|0.746
70880451|NCT02584504|141245804|SUPERIORITY||LS Mean Difference|-53.4|||<|0.0001|TWO_SIDED|97.5|-59.7|-47.1||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-47.1|-59.7|<0.0001
70880452|NCT02584504|141245805|SUPERIORITY||LS Mean Difference|-31.3|||<|0.0001|TWO_SIDED|97.5|-37.7|-25.0||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-25.0|-37.7|<0.0001
70880453|NCT02584504|141245805|SUPERIORITY||LS Mean Difference|-56.2|||<|0.0001|TWO_SIDED|97.5|-62.5|-49.8||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-49.8|-62.5|<0.0001
70880454|NCT02584504|141245806|SUPERIORITY||LS Mean Difference|-32.4|||<|0.0001|TWO_SIDED|97.5|-38.6|-26.3||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-26.3|-38.6|<0.0001
70880455|NCT02584504|141245806|SUPERIORITY||LS Mean Difference|-57.6|||<|0.0001|TWO_SIDED|97.5|-63.8|-51.4||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-51.4|-63.8|<0.0001
70880456|NCT02584504|141245807|SUPERIORITY||LS Mean Difference|-22.5|||<|0.0001|TWO_SIDED|97.5|-27.4|-17.6||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-17.6|-27.4|<0.0001
70960084|NCT01786174|141424387|SUPERIORITY_OR_OTHER||Slope|0.25|STANDARD_ERROR_OF_MEAN|0.89||0.78|TWO_SIDED|95.0|-1.53|2.03|||Random slopes model|||Fingolimod vs. Placebo Weeks 0-4||2.03|-1.53|0.780
70880457|NCT02584504|141245807|SUPERIORITY||LS Mean Difference|-41.4|||<|0.0001|TWO_SIDED|97.5|-46.4|-36.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-36.5|-46.4|<0.0001
70880458|NCT02584504|141245808|SUPERIORITY||Odds Ratio (OR)|61.2|||<|0.0001|TWO_SIDED|97.5|13.9|268.9||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||268.9|13.9|<0.0001
70880459|NCT02584504|141245808|SUPERIORITY||Odds Ratio (OR)|281.4|||<|0.0001|TWO_SIDED|97.5|33.3|2382.2||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||2382.2|33.3|<0.0001
70880460|NCT02584504|141245809|SUPERIORITY||Odds Ratio (OR)|102.8|||<|0.0001|TWO_SIDED|97.5|19.0|556.8||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||556.8|19.0|<0.0001
70880461|NCT02584504|141245809|SUPERIORITY||Odds Ratio (OR)|500.8|||<|0.0001|TWO_SIDED|97.5|47.9|5230.9||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||5230.9|47.9|<0.0001
70880462|NCT02584504|141245810|SUPERIORITY||Adjusted Mean Difference|-32.9|||<|0.0001|TWO_SIDED|97.5|-43.4|-22.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-22.5|-43.4|<0.0001
70880463|NCT02584504|141245810|SUPERIORITY||Adjusted Mean Difference|-50.9|||<|0.0001|TWO_SIDED|97.5|-61.5|-40.3||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-40.3|-61.5|<0.0001
70880464|NCT02584504|141245811|SUPERIORITY||LS Mean Difference|5.7||||0.0241|TWO_SIDED|97.5|0.0|11.3||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||11.3|0.0|0.0241
70880465|NCT02584504|141245811|SUPERIORITY||LS Mean Difference|7.8||||0.0022|TWO_SIDED|97.5|2.1|13.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||13.5|2.1|0.0022
70880466|NCT02584504|141245812|SUPERIORITY||Adjusted Mean Difference|5.9||||0.2645|TWO_SIDED|97.5|-5.9|17.7||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||17.7|-5.9|0.2645
70880467|NCT02584504|141245812|SUPERIORITY||Adjusted Mean Difference|-11.6||||0.0299|TWO_SIDED|97.5|-23.5|0.4||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Robust||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||0.4|-23.5|0.0299
70880468|NCT03036098|141245850|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.0032|TWO_SIDED|95.0|0.64|0.97|||Log Rank|Stratified weighted log-rank test||||0.97|0.64|0.0032
70880469|NCT03036098|141245857|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0018|TWO_SIDED|95.0|0.59|0.88|||Log Rank|Stratified weighted log-rank test||||0.88|0.59|0.0018
70880470|NCT03036098|141245858|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0171|TWO_SIDED|95.0|0.63|0.96|||Log Rank|Stratified weighted log-rank test||||0.96|0.63|0.0171
70880471|NCT03453684|141245862|OTHER||Overall SE of the estimate|0.009|||||TWO_SIDED||||||||Standard error of the estimate of Typical value: 0.45 Standard error of the estimate of w\^2: 0.39|||||
70880472|NCT03453684|141245863|OTHER||Overall Standard Error of the Estimate|9.85|||||TWO_SIDED||||||||Standard error of the estimate of Typical value: 0.61 Standard error of the estimate of ꙍ\^2 (intersubject variability): \^a (fixed to 0)|||||
70880473|NCT03453684|141245864|OTHER||Overall Standard Error of the Estimate|8.37|||||TWO_SIDED||||||||Standard error of the estimate of Typical value: 0.02 Standard error of the estimate of ꙍ\^2 (intersubject variability): \^a (fixed to 0)|||||
70960085|NCT01786174|141424388|SUPERIORITY_OR_OTHER||Slope|-0.51|STANDARD_ERROR_OF_MEAN|2.26||0.823|TWO_SIDED|95.0|-5.0|3.99|||Random slopes model|||Fingolimod vs. Placebo Weeks 0-4||3.99|-5.00|0.823
70880474|NCT03453684|141245865|OTHER||Overall Standard Error of the Estimate|4.83|||||TWO_SIDED||||||||Standard error of the estimate of Typical value: 0.003 Standard error of the estimate of ꙍ\^2 (intersubject variability): 0.03|||||
70880475|NCT03453684|141245866|OTHER||Overall Standard Error of the Estimate|17.21|||||TWO_SIDED||||||||Standard error of the estimate of Typical value: 0.13|||||
70880476|NCT03453684|141245867|OTHER||SE of the estimate of Typical Value|0.2|||||TWO_SIDED|||||||||||||
70880477|NCT03453684|141245868|OTHER||SE of the estimate of Typical Value|2.1|||||TWO_SIDED||||||||Standard error of the estimate of Typical value should be read as: 2.1E-06 Standard error of the estimate of ꙍ\^2 (intersubject variability): 0.24|||||
70960086|NCT01786174|141424390|SUPERIORITY_OR_OTHER||Slope|4.27|STANDARD_ERROR_OF_MEAN|4.04||0.294|TWO_SIDED|95.0|-3.78|12.33|||Random slopes model|||Fingolimod vs. Placebo Weeks 0-4||12.33|-3.78|0.294
70960087|NCT03442985|141424395|OTHER||Risk Ratio (RR)|2.109||||0.2556|TWO_SIDED|95.0|0.583|7.638||The p-values were not adjusted for multiple testing due to small sample size.|Negative binomial regression model|||Palovarotene 2.5 mg versus (vs) Palovarotene 5.0 mg: The annualized rate for number of new OCs was estimated using an unadjusted negative binomial regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||7.638|0.583|0.2556
70960088|NCT03442985|141424395|OTHER||Risk Ratio (RR)|3.04||||0.1788|TWO_SIDED|95.0|0.601|15.373||The p-values were not adjusted for multiple testing due to small sample size.|Negative binomial regression model|||Palovarotene 2.5 mg vs Placebo: The annualized rate for number of new OCs was estimated using an unadjusted negative binomial regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||15.373|0.601|0.1788
70960089|NCT03442985|141424395|OTHER||Risk Ratio (RR)|1.441||||0.657|TWO_SIDED|95.0|0.287|7.234||The p-values were not adjusted for multiple testing due to small sample size.|Negative binomial regression model|||Palovarotene 5.0 mg vs Placebo: The annualized rate for number of new OCs was estimated using an unadjusted negative binomial regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||7.234|0.287|0.6570
70960090|NCT03442985|141424396|OTHER||Risk Ratio (RR)|-4412.6||||0.4252|TWO_SIDED|95.0|-15257.3|6432.1||The p-values were not adjusted for multiple testing due to small sample size.|Unadjusted estimation equation model|||Palovarotene 2.5 mg vs Palovarotene 5.0 mg: The mean difference in the change from baseline for total OC volume was estimated using an unadjusted estimation equation model with independent working covariance matrix to address potential correlation within the same family members.||6432.1|-15257.3|0.4252
70960091|NCT03442985|141424396|OTHER||Risk Ratio (RR)|-4640.9||||0.4053|TWO_SIDED|95.0|-15570.8|6289.0||The p-values were not adjusted for multiple testing due to small sample size.|Unadjusted estimation equation model|||Palovarotene 2.5 mg vs Placebo: The mean difference in the change from baseline for total OC volume was estimated using an unadjusted estimation equation model with independent working covariance matrix to address potential correlation within the same family members.||6289.0|-15570.8|0.4053
70960092|NCT03442985|141424396|OTHER||Risk Ratio (RR)|-228.3||||0.9677|TWO_SIDED|95.0|-11265.0|10808.4||The p-values were not adjusted for multiple testings due to small sample size.|Unadjusted estimation equation model|||Palovarotene 5.0 mg vs Placebo: The mean difference in the change from baseline for total OC volume was estimated using an unadjusted estimation equation model with independent working covariance matrix to address potential correlation within the same family members.||10808.4|-11265.0|0.9677
70960093|NCT03442985|141424397|OTHER||Odds Ratio (OR)|0.643||||0.5025|TWO_SIDED|95.0|0.177|2.335|||Regression, Logistic|Logistic regression was adjusted for the following covariates: baseline age, sex, and Ext1/2 mutation status.||||2.335|0.177|0.5025
70960094|NCT03442985|141424397|OTHER||Odds Ratio (OR)|0.528||||0.3763|TWO_SIDED|95.0|0.128|2.175|||Regression, Logistic|Logistic regression was adjusted for the following covariates: baseline age, sex, and Ext1/2 mutation status.||||2.175|0.128|0.3763
70960095|NCT03442985|141424397|OTHER||Odds Ratio (OR)|0.82||||0.7714|TWO_SIDED|95.0|0.215|3.123|||Regression, Logistic|Logistic regression was adjusted for the following covariates: baseline age, sex, and Ext1/2 mutation status.||||3.123|0.215|0.7714
70960096|NCT03442985|141424398|OTHER||Risk Ratio (RR)|0.951||||0.8155|TWO_SIDED|95.0|0.623|1.451||The p-values were not adjusted for multiple testing due to small sample size. The correlation matrix type = compound symmetry was used.|Negative binomial regression model|||Palovarotene 2.5 mg vs Palovarotene 5.0 mg: The annualized rate for number of new or worsening deformities was estimated using an unadjusted negative binomial regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||1.451|0.623|0.8155
70960097|NCT03442985|141424398|OTHER||Risk Ratio (RR)|1.003||||0.9918|TWO_SIDED|95.0|0.592|1.699||The p-values were not adjusted for multiple testing due to small sample size. The correlation matrix type = compound symmetry was used.|Negative binomial regression model|||Palovarotene 2.5 mg vs Placebo: The annualized rate for number of new or worsening deformities was estimated using an unadjusted negative binomial regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||1.699|0.592|0.9918
70960098|NCT03442985|141424398|OTHER||Risk Ratio (RR)|1.055||||0.7997|TWO_SIDED|95.0|0.7|1.589||The p-values were not adjusted for multiple testing due to small sample size. The correlation matrix type = compound symmetry was used.|Negative binomial regression model|||Palovarotene 5.0 mg vs Placebo: The annualized rate for number of new or worsening deformities was estimated using an unadjusted negative binomial regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||1.589|0.700|0.7997
70960099|NCT03442985|141424399|OTHER||Risk Ratio (RR)|1.548||||0.2186|TWO_SIDED|95.0|0.772|3.108||The p-values were not adjusted for multiple testing due to small sample size. The correlation matrix type = independent was used.|Poisson regression model|||Palovarotene 2.5 mg vs Palovarotene 5.0 mg: The annualized rate for number of MO-related surgeries was estimated using an unadjusted poisson regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||3.108|0.772|0.2186
70960100|NCT03442985|141424399|OTHER||Risk Ratio (RR)|1.655||||0.27|TWO_SIDED|95.0|0.676|4.052||The p-values were not adjusted for multiple testing due to small sample size. The correlation matrix type = independent was used.|Poisson regression model|||Palovarotene 2.5 mg vs Placebo: The annualized rate for number of MO-related surgeries was estimated using an unadjusted poisson regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||4.052|0.676|0.2700
70960101|NCT03442985|141424399|OTHER||Risk Ratio (RR)|1.069||||0.8546|TWO_SIDED|95.0|0.524|2.178||The p-values were not adjusted for multiple testing due to small sample size. The correlation matrix type = independent was used.|Poisson regression model|||Palovarotene 5.0 mg vs Placebo: The annualized rate for number of MO-related surgeries was estimated using an unadjusted poisson regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||2.178|0.524|0.8546
70960102|NCT03645057|141424416|SUPERIORITY|||||||0.433|||||||Wilcoxon rank sum test|||||||0.433
70960103|NCT03645057|141424417|SUPERIORITY|||||||0.836|||||||Wilcoxon rank sum test|||||||0.836
70960104|NCT03645057|141424418|SUPERIORITY|||||||0.073|||||||Wilcoxon rank sum test|||||||0.073
70960105|NCT03645057|141424419|SUPERIORITY|||||||0.989|||||||Wilcoxon rank sum test|||||||0.989
70960106|NCT03645057|141424420|SUPERIORITY|||||||0.565|||||||Wilcoxon rank sum test|||||||0.565
70960107|NCT03645057|141424421|SUPERIORITY|||||||0.479|||||||Wilcoxon rank sum test|||||||0.479
70960108|NCT03645057|141424422|SUPERIORITY|||||||0.577|||||||Wilcoxon rank sum test|||||||0.577
70880478|NCT03453684|141245869|OTHER||SE of the estimate of Typical Value|2.3|||||TWO_SIDED||||||||Standard error of the estimate of ꙍ\^2 (intersubject variability): 0.08|||||
70880479|NCT03453684|141245870|OTHER||Overall Standard Error of the Estimate|10.8|||||TWO_SIDED||||||||Standard error of the estimate of Typical value: 0.02|||||
70880480|NCT03453684|141245871|OTHER||SE of the estimate of Typical Value|0.9|||||TWO_SIDED|||||||||||||
70880481|NCT00464568|141245913|SUPERIORITY_OR_OTHER||Treatment Ratios|1.14|STANDARD_ERROR_OF_MEAN|0.037||0.1351|TWO_SIDED|95.0|0.96|1.35|||ANOVA|||CREM; Placebo vs GSK256066 1 mcg||1.35|0.96|0.1351
70880482|NCT00464568|141245913|SUPERIORITY_OR_OTHER||Treatment Ratios|1.19|STANDARD_ERROR_OF_MEAN|0.037||0.0383|TWO_SIDED|95.0|1.01|1.41|||ANOVA|||CREM; Placebo vs GSK256066 10 mcg||1.41|1.01|0.0383
70960109|NCT03645057|141424423|SUPERIORITY|||||||0.439|||||||Wilcoxon (Mann-Whitney)|||||||0.439
70880483|NCT00464568|141245913|SUPERIORITY_OR_OTHER||Treatment Ratios|1.2|STANDARD_ERROR_OF_MEAN|0.037||0.0325|TWO_SIDED|95.0|1.02|1.43|||ANOVA|||CREM; Placebo vs GSK256066 50 mcg||1.43|1.02|0.0325
70880484|NCT00464568|141245913|SUPERIORITY_OR_OTHER||Treatment Ratios|1.42|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|1.2|1.68|||ANOVA|||CREM; Placebo vs GSK256066 200 mcg||1.68|1.20|<0.0001
70880485|NCT00464568|141245913|SUPERIORITY_OR_OTHER||Treatment Ratios|1.45|STANDARD_ERROR_OF_MEAN|0.049||0.0015|TWO_SIDED|95.0|1.16|1.82|||ANOVA|||DUSP1; Placebo vs GSK256066 1 mcg||1.82|1.16|0.0015
70960110|NCT03645057|141424424|SUPERIORITY|||||||0.242|||||||Wilcoxon rank sum test|||||||0.242
70960111|NCT00388453|141424432|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||.05
70960112|NCT03818204|141424447|OTHER||||||>=|0.46|||||||Regression, Linear|||The effect of angular position was modeled using linear mixed-effects (multiple regression) models. The five angles were randomly mapped for the dependent variable interpalpebral fissure. Because there were repeated measurements on each eye and each participant might respond differently to each angular position, participant and angular position within participant-eye were included as random effects.||||>=0.46
70960113|NCT01211197|141424541|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|100.59|STANDARD_DEVIATION|7.6|||TWO_SIDED|90.0|95.75|105.67|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Ratio calculated as FDC fasted divided by individual tablets fasted.||105.67|95.75|
70880486|NCT00464568|141245913|SUPERIORITY_OR_OTHER||Treatment Ratios|1.55|STANDARD_ERROR_OF_MEAN|0.049||0.0002|TWO_SIDED|95.0|1.24|1.93|||ANOVA|||DUSP1; Placebo vs GSK256066 10 mcg||1.93|1.24|0.0002
70880487|NCT00464568|141245913|SUPERIORITY_OR_OTHER||Treatment Ratios|1.74|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|1.38|2.17|||ANOVA|||DUSP1; Placebo vs GSK256066 50 mcg||2.17|1.38|<0.0001
70880488|NCT00464568|141245913|SUPERIORITY_OR_OTHER||Treatment Ratios|1.75|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001|TWO_SIDED|95.0|1.4|2.18|||ANOVA|||DUSP1; Placebo vs GSK256066 200 mcg||2.18|1.40|<0.0001
70880489|NCT00464568|141245913|SUPERIORITY_OR_OTHER||Treatment Ratios|1.49|STANDARD_ERROR_OF_MEAN|0.043||0.0001|TWO_SIDED|95.0|1.22|1.81|||ANOVA|||FOSL2; Placebo vs GSK256066 1 mcg||1.81|1.22|0.0001
70880490|NCT00464568|141245913|SUPERIORITY_OR_OTHER||Treatment Ratios|1.52|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|1.25|1.85|||ANOVA|||FOSL2; Placebo vs GSK256066 10 mcg||1.85|1.25|<0.0001
70880491|NCT00464568|141245913|SUPERIORITY_OR_OTHER||Treatment Ratios|1.68|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|1.38|2.05|||ANOVA|||FOSL2; Placebo vs GSK256066 50 mcg||2.05|1.38|<0.0001
70880492|NCT00464568|141245913|SUPERIORITY_OR_OTHER||Treatment Ratios|1.55|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|1.28|1.89|||ANOVA|||FOSL2; Placebo vs GSK256066 200 mcg||1.89|1.28|<0.0001
70880493|NCT00464568|141245913|SUPERIORITY_OR_OTHER||Treatment Ratios|1.55|STANDARD_ERROR_OF_MEAN|0.064||0.0034|TWO_SIDED|95.0|1.16|2.07|||ANOVA|||IRS2; Placebo vs GSK256066 1 mcg||2.07|1.16|0.0034
70880494|NCT00464568|141245913|SUPERIORITY_OR_OTHER||Treatment Ratios|1.55|STANDARD_ERROR_OF_MEAN|0.063||0.0029|TWO_SIDED|95.0|1.17|2.07|||ANOVA|||IRS2; Placebo vs GSK256066 10 mcg||2.07|1.17|0.0029
70880495|NCT00464568|141245913|SUPERIORITY_OR_OTHER||Treatment Ratios|1.74|STANDARD_ERROR_OF_MEAN|0.064||0.0003|TWO_SIDED|95.0|1.3|2.33|||ANOVA|||IRS2; Placebo vs GSK256066 50 mcg||2.33|1.30|0.0003
70880496|NCT00464568|141245913|SUPERIORITY_OR_OTHER||Treatment Ratios|1.56|STANDARD_ERROR_OF_MEAN|0.063||0.0027|TWO_SIDED|95.0|1.17|2.08|||ANOVA|||IRS2; Placebo vs GSK256066 200 mcg||2.08|1.17|0.0027
70880497|NCT00464568|141245913|SUPERIORITY_OR_OTHER||Treatment Ratios|1.54|STANDARD_ERROR_OF_MEAN|0.092||0.0448|TWO_SIDED|95.0|1.01|2.34|||ANOVA|||NR4A2; Placebo vs GSK256066 1 mcg||2.34|1.01|0.0448
70880498|NCT00464568|141245913|SUPERIORITY_OR_OTHER||Treatment Ratios|1.87|STANDARD_ERROR_OF_MEAN|0.091||0.0033|TWO_SIDED|95.0|1.24|2.83|||ANOVA|||NR4A2; Placebo vs GSK256066 10 mcg||2.83|1.24|0.0033
70960114|NCT01211197|141424541|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|94.94|STANDARD_DEVIATION|8.0|||TWO_SIDED|90.0|89.85|100.33|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted||100.33|89.85|
70960115|NCT01211197|141424542|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|99.31|STANDARD_DEVIATION|12.2|||TWO_SIDED|90.0|91.76|107.49|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fasted divided by individual tablets fasted||107.49|91.76|
70880499|NCT00464568|141245913|SUPERIORITY_OR_OTHER||Treatment Ratios|2.16|STANDARD_ERROR_OF_MEAN|0.092||0.0004|TWO_SIDED|95.0|1.42|3.3|||ANOVA|||NR4A2; Placebo vs GSK256066 50 mcg||3.30|1.42|0.0004
70880500|NCT00464568|141245913|SUPERIORITY_OR_OTHER||Treatment Ratios|2.03|STANDARD_ERROR_OF_MEAN|0.091||0.001||95.0|1.34|3.08|||ANOVA|||NR4A2; Placebo vs GSK256066 200 mcg||3.08|1.34|0.0010
70880501|NCT00464568|141245913|SUPERIORITY_OR_OTHER||Treatment Ratios|1.03|STANDARD_ERROR_OF_MEAN|0.072||0.8718|TWO_SIDED|95.0|0.74|1.43|||ANOVA|||PDE4A; Placebo vs GSK256066 1 mcg||1.43|0.74|0.8718
70880502|NCT00464568|141245913|SUPERIORITY_OR_OTHER||Treatment Ratios|1.18|STANDARD_ERROR_OF_MEAN|0.071||0.3078|TWO_SIDED|95.0|0.86|1.63|||ANOVA|||PDE4A; Placebo vs GSK256066 10 mcg||1.63|0.86|0.3078
70880503|NCT00464568|141245913|SUPERIORITY_OR_OTHER||Treatment Ratios|1.19|STANDARD_ERROR_OF_MEAN|0.072||0.2909|TWO_SIDED|95.0|0.86|1.66|||ANOVA|||PDE4A; Placebo vs GSK256066 50 mcg||1.66|0.86|0.2909
70880504|NCT00464568|141245913|SUPERIORITY_OR_OTHER||Treatment Ratios|1.38|STANDARD_ERROR_OF_MEAN|0.071||0.0539|TWO_SIDED|95.0|0.99|1.91|||ANOVA|||PDE4A; Placebo vs GSK256066 200 mcg||1.91|0.99|0.0539
70880505|NCT00464568|141245913|SUPERIORITY_OR_OTHER||Treatment Ratios|1.06|STANDARD_ERROR_OF_MEAN|0.081||0.7393|TWO_SIDED|95.0|0.74|1.54|||ANOVA|||RGS1; Placebo vs GSK256066 1 mcg||1.54|0.74|0.7393
70880506|NCT00464568|141245913|SUPERIORITY_OR_OTHER||Treatment Ratios|1.21|STANDARD_ERROR_OF_MEAN|0.08||0.2967|TWO_SIDED|95.0|0.84|1.74|||ANOVA|||RGS1; Placebo vs GSK256066 10 mcg||1.74|0.84|0.2967
70880507|NCT00464568|141245913|SUPERIORITY_OR_OTHER||Treatment Ratios|1.37|STANDARD_ERROR_OF_MEAN|0.081||0.0934|TWO_SIDED|95.0|0.95|1.98|||ANOVA|||RGS1; Placebo vs GSK256066 50 mcg||1.98|0.95|0.0934
70880508|NCT00464568|141245913|SUPERIORITY_OR_OTHER||Treatment Ratios|1.37|STANDARD_ERROR_OF_MEAN|0.08||0.0919|TWO_SIDED|95.0|0.95|1.97|||ANOVA|||RGS1; Placebo vs GSK256066 200 mcg||1.97|0.95|0.0919
70880509|NCT00464568|141245913|SUPERIORITY_OR_OTHER||Treatment Ratios|2.72|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|2.11|3.51|||ANOVA|||SNF1LK; Placebo vs GSK256066 1 mcg||3.51|2.11|<0.0001
70880510|NCT00464568|141245913|SUPERIORITY_OR_OTHER||Treatment Ratios|3.04|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001|TWO_SIDED|95.0|2.37|3.9|||ANOVA|||SNF1LK; Placebo vs GSK256066 10 mcg||3.90|2.37|<0.0001
70880511|NCT00464568|141245913|SUPERIORITY_OR_OTHER||Treatment Ratios|3.28|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|2.54|4.23|||ANOVA|||RGS1; Placebo vs GSK256066 50 mcg||4.23|2.54|<0.0001
70880512|NCT00464568|141245913|SUPERIORITY_OR_OTHER||Treatment Ratios|3.32|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001|TWO_SIDED|95.0|2.59|4.27|||ANOVA|||RGS1; Placebo vs GSK256066 200 mcg||4.27|2.59|<0.0001
70880513|NCT00464568|141245928|SUPERIORITY_OR_OTHER||Mean treatment difference|-0.5545|STANDARD_DEVIATION|7.79598||0.647226|||||||Mixed effects analysis of variance model|||Placebo vs GSK256066 1 mcg: VASP||||0.647226
70880514|NCT00464568|141245928|SUPERIORITY_OR_OTHER||Mean treatment difference|-0.3816|STANDARD_DEVIATION|9.00754||0.95084|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo vs GSK256066 10 mcg: VASP||||0.95084
70880515|NCT00464568|141245928|SUPERIORITY_OR_OTHER||Mean treatment difference|0.0256|STANDARD_DEVIATION|9.24118||0.53499|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo Vs GSK256066 50 mcg: VASP||||0.53499
70880516|NCT00464568|141245928|SUPERIORITY_OR_OTHER||Mean treatment difference|-1.3371|STANDARD_DEVIATION|7.5459||0.81527|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo vs GSK256066 200 mcg: VASP||||0.81527
70880517|NCT00464568|141245928|SUPERIORITY_OR_OTHER||Mean treatment difference|-2.8053|STANDARD_DEVIATION|10.88217||0.32998|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo Vs GSK256066 1 mcg: pVASP||||0.32998
70880518|NCT00464568|141245928|SUPERIORITY_OR_OTHER||Mean treatment difference|-1.6602|STANDARD_DEVIATION|12.30724||0.65729|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo vs GSK256066 10 mcg: pVASP||||0.65729
70880519|NCT00464568|141245928|SUPERIORITY_OR_OTHER||Mean treatment difference|0.156|STANDARD_DEVIATION|4.73976||0.89831|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo vs GSK256066 50 mcg: pVASP||||0.89831
70880520|NCT00464568|141245928|SUPERIORITY_OR_OTHER||Mean treatment difference|-1.5165|STANDARD_DEVIATION|12.70748||0.84479|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo vs GSK256066 200 mcg: pVASP||||0.84479
70880521|NCT00885755|141245937|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41|||||TWO_SIDED|95.0|0.109|1.535||||||Univariate Cox regression Hazard ratio (Positive / Negative) for the biomarker p95.||1.535|0.109|
70880522|NCT00885755|141245937|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.43|3.282||||||Univariate Cox regression: Hazard ratio (Membrane H-Score: \<median / ≥median) for the biomarker IGF1R.||3.282|0.430|
70880523|NCT00885755|141245937|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.306|2.425||||||Univariate Cox regression Hazard ratio (Membrane H-Score: \<median / ≥median) for the biomarker c-MET.||2.425|0.306|
70880524|NCT00885755|141245937|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||||TWO_SIDED|95.0|0.164|1.453||||||Univariate Cox regression Hazard ratio (Cytoplasm H-Score: \<median / ≥median) for the biomarker PTEN.||1.453|0.164|
70880525|NCT00885755|141245937|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.377|3.16||||||Univariate Cox regression Hazard ratio (Membrane H-Score: \< median / ≥median) for the biomarker HER2.||3.160|0.377|
70880526|NCT00885755|141245937|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.409|4.132||||||Univariate Cox regression Hazard ratio (Mutation Status: Wild type / Mutation) for the biomarker PI3K amino acids.||4.132|0.409|
70880527|NCT00885755|141245937|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.183|||||TWO_SIDED|95.0|0.226|6.197||||||Univariate Cox regression Hazard ratio (Phenotype: FF / VF) for the biomarker FC Gamma Receptor IIIa F176V.||6.197|0.226|
70880528|NCT00885755|141245937|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.989|||||TWO_SIDED|95.0|0.378|10.47||||||Univariate Cox regression Hazard ratio (Phenotype: FF / VV) for the biomarker FC Gamma Receptor IIIa F176V.||10.470|0.378|
70880529|NCT00885755|141245937|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.732|||||TWO_SIDED|95.0|0.235|12.783||||||Univariate Cox regression Hazard ratio (Phenotype: VF / VV) for the biomarker FC Gamma Receptor IIIa F176V.||12.783|0.235|
70960116|NCT01211197|141424542|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|64.3|STANDARD_DEVIATION|20.6|||TWO_SIDED|90.0|55.97|73.87|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted||73.87|55.97|
70960117|NCT01211197|141424543|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|100.94|STANDARD_DEVIATION|7.7|||TWO_SIDED|90.0|96.03|106.11|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fasted divided by individual tablets fasted||106.11|96.03|
70960118|NCT01211197|141424543|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|94.39|STANDARD_DEVIATION|8.2|||TWO_SIDED|90.0|89.22|99.87|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted||99.87|89.22|
70880530|NCT00885755|141245937|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.576|||||TWO_SIDED|95.0|0.067|4.968||||||Univariate Cox regression Hazard ratio (Phenotype: HH / HR) for the biomarker FC Gamma Receptor IIa R166H.||4.968|0.067|
70880531|NCT00885755|141245937|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.743|||||TWO_SIDED|95.0|0.082|6.72||||||Univariate Cox regression Hazard ratio (Phenotype: HH / RR) for the biomarker FC Gamma Receptor IIa R166H.||6.720|0.082|
70880532|NCT00885755|141245937|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.073|||||TWO_SIDED|95.0|0.274|4.199||||||Univariate Cox regression Hazard ratio (Phenotype: HR / RR) for the biomarker FC Gamma Receptor IIa R166H.||4.199|0.274|
70880533|NCT00885755|141245940|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.12|1.79||||||Univariate Cox regression Hazard ratio (Positive / Negative) for the biomarker p95 HER2.||1.790|0.120|
70880534|NCT00885755|141245940|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.394|3.518||||||Univariate Cox regressionHazard ratio (Membrane H-Score: \<median / ≥median) for the biomarker IGF1R.||3.518|0.394|
70880535|NCT00885755|141245940|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.268|2.514||||||Univariate Cox regression Hazard ratio (Membrane H-Score: \< median / ≥median) for the biomarker c-met.||2.514|0.268|
70880536|NCT00885755|141245940|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.183|1.768||||||Univariate Cox regression Hazard ratio (Cytoplasm H-Score: \< median / ≥median) for the marker PTEN.||1.768|0.183|
70880537|NCT00885755|141245940|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.242|2.733||||||Univariate Cox regression Hazard ratio (Membrane H-Score: \< median / ≥median) for the biomarker HER2.||2.733|0.242|
70880538|NCT00885755|141245940|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.337|3.632||||||Univariate Cox regressionHazard ratio (Mutation Status: Wild type / Mutation) for the biomarker PI3K amino acids.||3.632|0.337|
70880539|NCT00885755|141245940|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.957|||||TWO_SIDED|95.0|0.172|5.336||||||Hazard ratio (Phenotype: FF / VF) for the biomarker FC Gamma Receptor IIIa F176V.||5.336|0.172|
70880540|NCT00885755|141245940|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.666|||||TWO_SIDED|95.0|0.298|9.305||||||Hazard ratio (Phenotype: FF / VV) for the biomarker FC Gamma Receptor IIIa F176V.||9.305|0.298|
70880541|NCT00885755|141245940|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.732|||||TWO_SIDED|95.0|0.235|12.783||||||Hazard ratio (Phenotype: VF / VV) for the biomarker FC Gamma Receptor IIIa F176V.||12.783|0.235|
70880542|NCT00885755|141245940|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.576|||||TWO_SIDED|95.0|0.067|4.968||||||Univariate Cox regression Hazard ratio (Phenotype: HH / HR) for the biomarker FC Gamma Receptor IIa R166H.||4.968|0.067|
70880543|NCT00885755|141245940|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.956|||||TWO_SIDED|95.0|0.098|9.319||||||Univariate Cox regression Hazard ratio (Phenotype: HH / RR) for the biomarker FC Gamma Receptor IIa R166H.||9.319|0.098|
70880544|NCT00885755|141245940|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.292|||||TWO_SIDED|95.0|0.296|5.64||||||Univariate Cox regression Hazard ratio (Phenotype: HR / RR) for the biomarker FC Gamma Receptor IIa R166H.||5.640|0.296|
70880545|NCT00885755|141245948|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.03|||||TWO_SIDED|95.0|0.001|0.641||||||Univariate logistic regression Odds ratio (Positive / Negative) for the biomarker p95 HER 2.||0.641|0.001|
70880546|NCT00885755|141245948|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.208|||||TWO_SIDED|95.0|0.017|2.6||||||Univariate logistic regression Odds ratio (Membrane H-Score: ≥median /\<median) for the biomarker IGF1R.||2.600|0.017|
70880547|NCT00885755|141245948|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.143|||||TWO_SIDED|95.0|0.169|27.103||||||Univariate logistic regression Odds ratio (Membrane H-Score: ≥ median /\<median) for the biomarker c-MET.||27.103|0.169|
70880548|NCT00885755|141245948|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.875|||||TWO_SIDED|95.0|0.15|23.396||||||Univariate logistic regression Odds ratio (Cytoplasm H-Score: ≥ median /\< median) for the biomarker PTEN.||23.396|0.150|
70880549|NCT00885755|141245948|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.857|||||TWO_SIDED|95.0|0.091|8.075||||||Univariate logistic regression Odds ratio (Membrane H-Score: ≥median /\< median) for the biomarker HER2.||8.075|0.091|
70880550|NCT00885755|141245948|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.148|||||TWO_SIDED|95.0|0.012|1.9||||||Univariate logistic regression Odds ratio (PI3K mutation status: WT versus M) for the biomarker PI3K Amino Acids.||1.900|0.012|
70880551|NCT00885755|141245948|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.053|18.915||||||Univariate logistic regressionOdds ratio (Phenotype: FF / VF) for the biomarker FC Gamma Receptor IIIa F176V.||18.915|0.053|
70880552|NCT00885755|141245948|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.083|||||TWO_SIDED|95.0|0.004|1.945||||||Univariate logistic regression Odds ratio (Phenotype: HR / RR) for the biomarker FC Gamma Receptor IIa R166H||1.945|0.004|
70880553|NCT00751348|141245964|NON_INFERIORITY|Criterion for evaluation of non-inferiority: the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Priorix-Tetra Group minus Priorix+Varilrix Group) in seroconversion rate for anti-measles was above -10%.|Difference in percentage|-1.36|||<|0.05|TWO_SIDED|95.0|-3.77|1.66||The P-value for all reactogenicity comparisons was below (\<) 0.05.|Fisher Exact|||Non-inferiority of Priorix-Tetra® vaccine vs Priorix™ and Varilrix™ administered as concomitant vaccine 42-56 days after vaccination at Day 0 in terms of anti-measles seroconversion rates.||1.66|-3.77|<0.05
70880554|NCT00751348|141245964|NON_INFERIORITY|Criterion for evaluation of non-inferiority: the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Priorix-Tetra Group minus Priorix+Varilrix Group) in seroconversion rate for anti-mumps was above -10%.|Difference in percentage|-5.34|||<|0.05|TWO_SIDED|95.0|-10.4|0.38||The P-value for all reactogenicity comparisons was below (\<) 0.05.|Fisher Exact|||Non-inferiority of Priorix-Tetra® vaccine vs Priorix™ and Varilrix™ administered as concomitant vaccine 42-56 days after vaccination at Day 0 in terms of anti-mumps seroconversion rates.||0.38|-10.4|<0.05
70960119|NCT01211197|141424544|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|103.13|STANDARD_DEVIATION|11.7|||TWO_SIDED|90.0|95.59|111.25|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fasted divided by individual tablets fasted||111.25|95.59|
70960120|NCT01211197|141424544|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|96.96|STANDARD_DEVIATION|15.5|||TWO_SIDED|90.0|87.23|107.78|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted||107.78|87.23|
70960121|NCT01211197|141424545|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|102.15|STANDARD_DEVIATION|13.0|||TWO_SIDED|90.0|93.87|111.15|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fasted divided by individual tablets fasted||111.15|93.87|
70960122|NCT01211197|141424545|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|100.67|STANDARD_DEVIATION|13.7|||TWO_SIDED|90.0|91.7|110.51|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted||110.51|91.70|
70960123|NCT01211197|141424546|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|103.49|STANDARD_DEVIATION|12.7|||TWO_SIDED|90.0|95.3|112.39|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fasted divided by individual tablets fasted||112.39|95.30|
70960124|NCT01211197|141424546|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|75.13|STANDARD_DEVIATION|24.5|||TWO_SIDED|90.0|63.68|88.64|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted||88.64|63.68|
70960125|NCT00892723|141424599|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.87
70960126|NCT00892723|141424599|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.86
70960127|NCT00892723|141424599|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.11
70960128|NCT00892723|141424599|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.91
70960129|NCT00892723|141424600|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.23
70960130|NCT00892723|141424600|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.82
70960131|NCT00892723|141424600|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.23
70960132|NCT00892723|141424600|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.71
70960133|NCT00892723|141424601|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.73
70960134|NCT00892723|141424601|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.94
70960135|NCT00892723|141424601|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.14
70960136|NCT00892723|141424601|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.68
70960137|NCT00892723|141424601|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.56
70960138|NCT00892723|141424601|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.32
70960139|NCT00892723|141424601|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.33
70960140|NCT00892723|141424601|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.65
70960141|NCT00892723|141424601|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.21
70960142|NCT00892723|141424601|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.90
70960143|NCT00892723|141424602|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED|95.0|||||Wilcoxon (signed rank)|For this early phase study, no adjustment was used.||||||0.16
70960144|NCT00892723|141424602|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED|95.0||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)|||||||0.74
70960145|NCT00892723|141424602|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED|95.0||||For this early phase study, no adjustments were used.|Wilcoxon (signed rank)|||||||0.45
70960146|NCT00892723|141424602|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED|95.0|||||Wilcoxon (signed rank)|For this early phase study, no adjustments were used.||||||0.079
70960147|NCT00892723|141424602|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED|95.0|||||Wilcoxon (signed rank)|For this early phase study, no adjustments were used.||||||0.16
70960148|NCT00892723|141424602|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED|95.0||||For this early phase study, no adjustments were used.|Wilcoxon (signed rank)|For this early phase study, no adjustments were used.||||||0.45
70960149|NCT00150969|141424603|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
70960150|NCT00150969|141424610|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
70960151|NCT01313689|141424630|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.2677|TWO_SIDED|95.0|0.5|1.24|||Log Rank|P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum|||1.24|0.50|0.2677
70960152|NCT01313689|141424630|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.54||||0.0837|TWO_SIDED|95.0|0.19|1.53|||Log Rank|P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum|||1.53|0.19|0.0837
70960153|NCT01313689|141424631|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.56||||0.003|TWO_SIDED|95.0|0.35|0.87|||Log Rank|P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum.|||0.87|0.35|0.0030
70960154|NCT01313689|141424631|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49||||0.0262|TWO_SIDED|95.0|0.21|1.17|||Log Rank|P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum|||1.17|0.21|0.0262
70960155|NCT01313689|141424632|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.942||||0.0223|TWO_SIDED|95.0|1.166|7.424|||Regression, Logistic|conditional logistic regression with interval and pooled stratum||||7.424|1.166|0.0223
70960156|NCT01313689|141424632|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|999.999||||0.9985|TWO_SIDED|95.0|0.001|999.999|||Regression, Logistic|conditional logistic regression with interval and pooled stratum||||999.999|0.001|0.9985
70960157|NCT01313689|141424633|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.366||||0.4159|TWO_SIDED|95.0|0.644|2.899||Odds ratios and p-value are based on conditional logistic regression with interval and pooled stratum included in the Strata statement|Regression, Logistic|||||2.899|0.644|0.4159
70960158|NCT01313689|141424633|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.225||||0.8866|TWO_SIDED|95.0|0.076|19.862||Odds ratios and p-value are based on conditional logistic regression with interval and pooled stratum in the strata statement|Regression, Logistic|||||19.862|0.076|0.8866
70960159|NCT01313689|141424634|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.1732|TWO_SIDED|95.0|0.48|1.17|||Log Rank|P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum|||1.17|0.48|0.1732
70960160|NCT01313689|141424634|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.8128|TWO_SIDED|95.0|0.46|2.68||P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Log Rank||Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum|||2.68|0.46|0.8128
70960161|NCT01337115|141424670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.44|STANDARD_ERROR_OF_MEAN|8.4||0.001|TWO_SIDED|95.0|11.55|45.34|||t-test, 2 sided|||Difference between mean VAS pain scores. Power 80%. Null hypothesis states there is no difference between pains scores in both groups||45.34|11.55|0.001
70960162|NCT01337115|141424671|SUPERIORITY_OR_OTHER|||||||0.537||||||The null hypothesis is that there is no difference in patient satisfaction distribution by the three categories used (Bad; Reasonable; Good/Very Good) between groups.|Fisher's exact test|Fisher's Exact test allows to test for the significance of the distribution in the results table with three categories.||||||0.537
70960163|NCT01337115|141424672|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|16.92|STANDARD_ERROR_OF_MEAN|5.67||0.006|TWO_SIDED|95.0|5.52|28.33|||t-test, 2 sided|||Null hypothesis states that there is no difference between groups. Power 80%||28.33|5.52|0.006
70960164|NCT01337115|141424673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.55|STANDARD_ERROR_OF_MEAN|7.14||0.723|TWO_SIDED|95.0|-16.93|11.83|||t-test, 2 sided|||Null hypothesis states there is no difference between both groups. Power 80% to detect 15% difference in means||11.83|-16.93|0.723
70960165|NCT00406653|141424743|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.611|TWO_SIDED|95.0|0.6|2.4||Due to randomization misspecification, 2:2:2:1 ratio applied instead of planned 2:1:2:2 (placebo, ABA 3mg/kg, \~10mg/kg, 30/\~10mg/kg). Only \~half intended number assigned to ABA 30/\~10 mg/kg arm and \~double intended number assigned to ABA 3 mg/kg arm|Cochran-Mantel-Haenszel|Second primary comparison (conditional on first): power=91%, sample size=134, 5% significance; expected PLA response rate= 25%, ABA/\~10 mg/kg=45%|All participants who prematurely discontinued for any reason considered not to have achieved clinical response. Normal approximation used if number of responses in treatment group was ≥5. Otherwise an exact method was used.|Conditional on abatacept (ABA) 30/\~10 mg/kg vs placebo (PLA)comparison being statistically significant at 5% significance level, ABA \~10 mg/kg vs PLA to be tested at 5% significance level. Null hypothesis=no treatment difference (relative risk \[RR\] of ABA over placebo=1).First comparison: power=99%,sample size=134,expected PLA response rate=25%, ABA 30/\~10 mg/kg=55%. Cochran-Mantel-Haenszel Chi square p-value and RR along with 95% confidence interval provided, adjusting for randomization strata||2.4|0.6|0.611
70960166|NCT00406653|141424746|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.18|||||TWO_SIDED|95.0|0.4|3.44||Due to randomization misspecification, 2:2:2:1 ratio applied instead of planned 2:1:2:2 (placebo, ABA mg/kg, \~10 mg/kg, 30/\~10 mg/kg). Only \~half intended number assigned to ABA 30/\~10 mg/kg arm and \~double intended number assigned to ABA 3 mg/kg arm|Cochran-Mantel-Haenszel|Second primary comparison (conditional on first): power=80%, sample size=134, 5% significance; expected PLA response rate= 15%, ABA/\~10 mg/kg=30%|All participants who prematurely discontinued for any reason considered not to have achieved clinical response. Normal approximation used if number of responses in treatment group was ≥5. Otherwise an exact method was used.|Conditional on abatacept (ABA) 30/\~10 mg/kg vs placebo (PLA)comparison being statistically significant at 5% significance level, ABA \~10 mg/kg vs PLA to be tested at 5% signficance level. Null hypothesis=no treatment difference (relative risk \[RR\] of ABA over placebo=1).First comparison: power=95%,sample size=134,expected PLA response rate=15%, ABA 30/\~10 mg/kg=35%. Cochran-Mantel-Haenszel Chi square p-value and RR along with 95% confidence interval provided, adjusting for randomization strata||3.44|0.4|
70960167|NCT00406653|141424747|SUPERIORITY_OR_OTHER|||||||0.436||95.0||||All statistical testing was performed at a pre-specified alpha-level of 5%.|Cochran-Armitage Trend Test|||The Cochran-Armitage trend test was performed to evaluate whether a relationship existed between the response and dose regimen by comparing the proportion of participants in response across all four treatment arms. Normal approximation was used if the number of responses in a treatment group is at least 5. Otherwise an exact method was used.||||0.436
70960168|NCT00406653|141424754|SUPERIORITY_OR_OTHER|||||||0.112|TWO_SIDED|95.0||||All statistical testing was performed at a pre-specified alpha-level of 5%.|Cochran-Armitage Trend Test|||The Cochran-Armitage trend test was performed to evaluate whether a relationship existed between the response and dose regimen by comparing the proportion of participants in response across all four treatment arms. Normal approximation was used if the number of responses in a treatment group is at least 5. Otherwise an exact method was used.||||0.112
70960169|NCT03513588|141424775|OTHER||Least Squares Mean Difference|-24.34|||<|0.001|TWO_SIDED|80.0|-31.28|-16.7|||ANCOVA|||||-16.70|-31.28|<0.001
70960170|NCT03513588|141424775|OTHER||Least Squares Mean Difference|-33.91|||<|0.001|TWO_SIDED|80.0|-39.78|-27.47|||ANCOVA|||||-27.47|-39.78|<0.001
70960171|NCT01054846|141424856|SUPERIORITY_OR_OTHER||z value|2.696|||<|0.01|TWO_SIDED||||||Chi-squared|||Differences between Survey 1 and Survey 2||||<0.01
70960172|NCT01054846|141424856|SUPERIORITY_OR_OTHER||z value|1.351|||>|0.05|TWO_SIDED||||||Chi-squared|||Difference between Survey 1 and Survey 2||||>0.05
70960173|NCT02446886|141424858|SUPERIORITY||Mean Difference (Final Values)|1.65||||0.04|TWO_SIDED||||||t-test, 2 sided|||Previously published reproducibility of our MWF imaging (FAST-T2) has been established to be +/- 2.0 Our hypothesis for this study was the monthly ACTH would lead to greater remylination in acute MS lesions. However, to reach this goal, improvement must be beyond established reproducibility. Note: Since MWF is a fraction of myelin water to total water, it does not have a unit.||||0.04
70960174|NCT02446886|141424863|SUPERIORITY||Mean Difference (Final Values)|1.65||||0.077|TWO_SIDED||||||Mixed Models Analysis|||Linear mixed-effects models were implemented to assess the variables of interest (lesion MWF) among patients randomized to once versus the monthly ACTH treatment group. The modeling strategy accounts for multiple lesions per patient, repeated measurements (longitudinal analysis) and the following covariates were always considered: patient age, gender, disease duration, individual T2w lesion volume, time on disease modifying treatments (DMT) prior to enrollment, and DMT during the study.|Linear mixed-effects models were implemented|||0.077
70960175|NCT02988622|141424870|SUPERIORITY||Mean Difference (Net)|0.1205|STANDARD_DEVIATION|0.5499||0.0492|TWO_SIDED||||||t-test, 2 sided|||||||0.0492
70960176|NCT02988622|141424871|SUPERIORITY||Mean Difference (Net)|0.241|STANDARD_DEVIATION|0.0817||0.0817|TWO_SIDED||||||t-test, 2 sided|||||||0.0817
70960177|NCT02988622|141424872|SUPERIORITY||Mean Difference (Net)|0.3659|STANDARD_DEVIATION|1.7951||0.0686|TWO_SIDED||||||t-test, 2 sided|||||||0.0686
70960178|NCT02988622|141424873|SUPERIORITY||Mean Difference (Net)|-0.0843|STANDARD_DEVIATION|1.5789||0.6278|TWO_SIDED||||||t-test, 2 sided|||||||0.6278
70960179|NCT02988622|141424874|SUPERIORITY||Mean Difference (Net)|0.3373|STANDARD_DEVIATION|1.7619||0.0848|TWO_SIDED||||||t-test, 2 sided|||||||0.0848
70960180|NCT02988622|141424875|SUPERIORITY||Mean Difference (Net)|0.2195|STANDARD_DEVIATION|2.0788||0.3418|TWO_SIDED||||||t-test, 2 sided|||||||0.3418
70960181|NCT02988622|141424876|SUPERIORITY||Mean Difference (Net)|0.2375|STANDARD_DEVIATION|1.5528||0.1752|TWO_SIDED||||||t-test, 2 sided|||||||0.1752
70960182|NCT02988622|141424878|SUPERIORITY||Mean Difference (Net)|0.3824|STANDARD_DEVIATION|1.5685||0.0281|TWO_SIDED||||||t-test, 2 sided|||||||0.0281
70960183|NCT06020118|141424892|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.938|TWO_SIDED|95.0||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H1N1)pdm09||||0.938
70960184|NCT06020118|141424892|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.451||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H3N2)||||0.451
70960185|NCT06020118|141424892|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.819||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Victoria||||0.819
70960186|NCT06020118|141424892|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.5||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Yamagata||||0.500
70960187|NCT06020118|141424892|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H1N1)pdm09||||<.001
70960188|NCT06020118|141424892|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.001||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H3N2)||||0.001
70960189|NCT06020118|141424892|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Victoria||||<0.001
70960190|NCT06020118|141424892|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Yamagata||||<0.001
70960191|NCT06020118|141424893|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.894||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H1N1)pdm09||||0.894
70960192|NCT06020118|141424893|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.104||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H3N2)||||0.104
70960193|NCT06020118|141424893|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.815||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Victoria||||0.815
70960194|NCT06020118|141424893|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.814||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Yamagata||||0.814
70960195|NCT06020118|141424893|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H1N1)pdm09||||<0.001
70960196|NCT06020118|141424893|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H3N2)||||<0.001
70960197|NCT06020118|141424893|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Victoria||||<0.001
70960198|NCT06020118|141424893|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Yamagata||||<0.001
70960199|NCT06020118|141424894|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.699||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen A(H1N1)pdm09||||0.699
70960200|NCT06020118|141424894|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.88||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen A(H1N1)pdm09||||0.880
70960201|NCT06020118|141424894|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.72||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen A(H3N2)||||0.720
70960202|NCT06020118|141424894|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.238||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen A(H3N2)||||0.238
70960203|NCT06020118|141424894|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.28||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen B/Victoria||||0.280
70960204|NCT06020118|141424894|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.094||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen B/Victoria||||0.094
70960205|NCT06020118|141424894|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.216||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen B/Yamagata||||0.216
70960206|NCT06020118|141424894|SUPERIORITY|P values and confidence intervals for the geometric mean titer ratio were estimated using a generalized estimating equation logistic regression accounting for site clustering.||||||0.436||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen B/Yamagata||||0.436
70880555|NCT00751348|141245964|NON_INFERIORITY|Criterion for evaluation of non-inferiority: the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Priorix-Tetra Group minus Priorix+Varilrix Group) in seroconversion rate for anti-rubella was above -10%.|Difference in percentage|-0.34|||<|0.05|TWO_SIDED|95.0|-1.88|2.06||The P-value for all reactogenicity comparisons was below (\<) 0.05.|Fisher Exact|||Non-inferiority of Priorix-Tetra® vaccine vs Priorix™ and Varilrix™ administered as concomitant vaccine 42-56 days after vaccination at Day 0 in terms of anti-rubella seroconversion rates.||2.06|-1.88|<0.05
70880556|NCT00751348|141245964|NON_INFERIORITY|Criterion for evaluation of non-inferiority: the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Priorix-Tetra Group minus Priorix+Varilrix Group) in seroconversion rate for anti-VZV was above -10%.|Difference in percentage|-1.06|||<|0.05|TWO_SIDED|95.0|-3.07|1.44||The P-value for all reactogenicity comparisons was below (\<) 0.05.|Fisher Exact|||Non-inferiority of Priorix-Tetra® vaccine vs Priorix™ and Varilrix™ administered as concomitant vaccine 42-56 days after vaccination at Day 0 in terms of anti-varicella zoster virus (anti-VZV) seroconversion rates.||1.44|-3.07|<0.05
70880557|NCT04191382|141245973|OTHER|Other descriptive analysis|Ratio of Geometric Means|1.08|||||TWO_SIDED|95.0|0.72|1.63||||||Geometric LS-means ratio of proportional change was the ratio of geometric LS-means of the proportional change between groups (Amcenestrant 400 mg versus Letrozole 2.5 mg).||1.63|0.72|
70880558|NCT04191382|141245973|OTHER|Other descriptive analysis|Ratio of Geometric Means|1.42|||||TWO_SIDED|95.0|0.95|2.12||||||Geometric LS-means ratio of proportional change was the ratio of geometric LS-means of the proportional change between groups (Amcenestrant 200 mg versus Letrozole 2.5 mg).||2.12|0.95|
70880559|NCT02867709|141245981|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0285|TWO_SIDED|95.0|1.09|2.22||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.22|1.09|0.0285
70880560|NCT02867709|141245981|SUPERIORITY||Odds Ratio (OR)|1.62||||0.0129|TWO_SIDED|95.0|1.14|2.29||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.29|1.14|0.0129
70880561|NCT02867709|141245982|SUPERIORITY||Odds Ratio (OR)|1.37||||0.0711|TWO_SIDED|95.0|1.02|1.83||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, underlying symptom as explanatory variables.||||1.83|1.02|0.0711
70960207|NCT06020118|141424894|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.615||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen A(H1N1)pdm09||||0.615
70880562|NCT02867709|141245982|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0129|TWO_SIDED|95.0|1.25|2.2||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, underlying symptom as explanatory variables.||||2.20|1.25|0.0129
70880563|NCT02867709|141245983|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0711|TWO_SIDED|95.0|1.25|2.17||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.17|1.25|0.0711
70880564|NCT02867709|141245983|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0129|TWO_SIDED|95.0|1.35|2.32||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.32|1.35|0.0129
70880565|NCT02867709|141245984|SUPERIORITY||Odds Ratio (OR)|1.82||||0.0711|TWO_SIDED|95.0|1.33|2.48||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.48|1.33|0.0711
70880566|NCT02867709|141245984|SUPERIORITY||Odds Ratio (OR)|2.16||||0.0129|TWO_SIDED|95.0|1.59|2.92||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.92|1.59|0.0129
70880567|NCT02867709|141245985|SUPERIORITY||Odds Ratio (OR)|1.62||||0.0711|TWO_SIDED|95.0|1.04|2.53||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.53|1.04|0.0711
70880568|NCT02867709|141245985|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0129|TWO_SIDED|95.0|1.2|2.83||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.83|1.20|0.0129
70880569|NCT02867709|141245986|SUPERIORITY||Odds Ratio (OR)|1.28||||0.1833|TWO_SIDED|95.0|0.96|1.72||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, photophobia were explanatory variables.||||1.72|0.96|0.1833
70880570|NCT02867709|141245986|SUPERIORITY||Odds Ratio (OR)|1.52||||0.0167|TWO_SIDED|95.0|1.14|2.02||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, photophobia were explanatory variables.||||2.02|1.14|0.0167
70880571|NCT02867709|141245987|SUPERIORITY||Odds Ratio (OR)|1.38||||0.1066|TWO_SIDED|95.0|1.04|1.83||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, phonophobia were explanatory variables.||||1.83|1.04|0.1066
70880572|NCT02867709|141245987|SUPERIORITY||Odds Ratio (OR)|1.39||||0.044|TWO_SIDED|95.0|1.05|1.84||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, phonophobia were explanatory variables.||||1.84|1.05|0.0440
70880573|NCT02867709|141245988|SUPERIORITY||Odds Ratio (OR)|1.1||||0.9522|TWO_SIDED|95.0|0.81|1.49||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, nausea were explanatory variables.||||1.49|0.81|0.9522
70880574|NCT02867709|141245988|SUPERIORITY||Odds Ratio (OR)|1.12||||0.9522|TWO_SIDED|95.0|0.83|1.51||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, nausea were explanatory variables.||||1.51|0.83|0.9522
70880575|NCT00663052|141245998|SUPERIORITY_OR_OTHER||Proportion difference|18.34||||0.0015|TWO_SIDED|95.0|6.8|29.88|||Fisher Exact||Primary endpoint used 95% CI to compare to prespecified target rates for each treatment arm.|With 125 participants/group, estimation was: 1)approximately 90% power to reject null hypothesis- PASI 75 response rate at 24 weeks: 50% in ETN 50 mg QW, assuming true rate is 65% or greater; 2)90% power to reject null hypothesis- PASI 75 response rate at 24 weeks: 60% in 50 mg BIW, assuming true rate is 74% or greater. The 95% CI widths on these are approximately ±8.8%, indicating PASI 75 for ETN 50 mg QW and ETN 50 mg BIW must be at least 58.8% \& 68.8%, respectively to reject null hypotheses.||29.88|6.80|0.0015
70880576|NCT00663052|141245999|SUPERIORITY_OR_OTHER||Proportion difference|3.14||||0.3605|TWO_SIDED|95.0|-3.88|10.16|||Fisher Exact|||Comparison between treatment groups at Week 2||10.16|-3.88|0.3605
70880577|NCT00663052|141245999|SUPERIORITY_OR_OTHER||Proportion difference|17.91||||0.0013|TWO_SIDED|95.0|6.5|29.32|||Fisher Exact|||Comparison between treatment groups at Week 4||29.32|6.50|0.0013
70960208|NCT06020118|141424894|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen A(H1N1)pdm09||||<0.001
70960209|NCT06020118|141424894|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.87||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen A(H3N2)||||0.870
70880578|NCT00663052|141245999|SUPERIORITY_OR_OTHER||Proportion difference|19.6||||0.0011|TWO_SIDED|95.0|7.51|31.7|||Fisher Exact|||Comparison between treatment groups at Week 8||31.70|7.51|0.0011
70960210|NCT06020118|141424894|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001|||||||Regression, Linear|GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.||Post-vaccine: Antigen A(H3N2)||||<0.001
70960211|NCT06020118|141424894|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.64||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen B/Victoria||||0.640
70960212|NCT06020118|141424894|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen B/Victoria||||<0.001
70960213|NCT06020118|141424894|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.444||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen B/Yamagata||||0.444
70960214|NCT06020118|141424894|SUPERIORITY|P values and confidence intervals for the geometric mean titer ratio were estimated using a generalized estimating equation logistic regression accounting for site clustering.|||||<|0.001||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen B/Yamagata||||<0.001
70960215|NCT06020118|141424895|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.793||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: A(H1N1)pdm09||||0.793
70960216|NCT06020118|141424895|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.326||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: A(H3N2)||||0.326
70960217|NCT06020118|141424895|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.933||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: B/Victoria||||0.933
70960218|NCT06020118|141424895|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.424||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: B/Yamagata||||0.424
70960219|NCT06020118|141424895|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: A(H1N1)pdm09||||<0.001
70960220|NCT06020118|141424895|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: A(H3N2)||||<0.001
70960221|NCT06020118|141424895|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: B/Victoria||||<0.001
70960222|NCT06020118|141424895|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: B/Yamagata||||<0.001
70960223|NCT03261700|141424896|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Comparison of groups on Empowerment via the Personal Progress Scale Revised||||<.05
70960224|NCT03261700|141424897|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Comparison of groups on self-efficacy via the General Self-Efficacy Scale||||<.05
70960225|NCT01281969|141424927|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.97||||0.44|TWO_SIDED|95.0|-7.1|3.15||p-value is unadjusted. a priori threshold for statistical significance is .05|ANCOVA|F(1,34)=0.62, p=.44||Analysis of covariance model controlling for baseline scores. A priori power calculations based on the Perlmutter et al. study (IVIG effect size 1.2) suggested that a sample size of 16 per group would be sufficient to detect an effect size of 1.0 with 80% power.||3.15|-7.1|0.44
70880579|NCT00663052|141245999|SUPERIORITY_OR_OTHER||Proportion difference|20.09|||<|0.0001|TWO_SIDED|95.0|9.77|30.4|||Fisher Exact|||Comparison between treatment groups at Week 12||30.40|9.77|<.0001
70960226|NCT01281969|141424928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||p-value is not adjusted.|Wilcoxon (Mann-Whitney)|Mean rank sum in the placebo group = 19.92; mean rank sum in the IVIG group = 15.97. Z = -1.18, p=.12||The Wilcoxon two-sample test was used to compare CGI-Improvement ratings (an ordinal variable) at week 6. Power calculation was based on CYBOCS as primary outcome.||||.12
70960227|NCT01281969|141424929|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4||||||p-value is not adjusted for multiple comparisons.|Chi-squared|X2 = 0.72, p=.40||Chi-squared test was used to compare distribution of responders by randomization group. Power calculation was based on CY-BOCS (primary outcome).||||.40
70960228|NCT01257425|141424960|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin defined as 0.8 to 1.25|Ratio of AUC values|0.977|||||TWO_SIDED|90.0|0.88|1.08|||ANCOVA|||||1.08|0.88|
70960229|NCT01257425|141424961|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin is 0.8 to 1.25|Ratio of AUC values|0.932|||||TWO_SIDED|90.0|0.82|1.06|||ANCOVA|||||1.06|0.82|
70960230|NCT01257425|141424962|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin is 0.8 to 1.25|Ratio of AUC values|0.91|||||TWO_SIDED|90.0|0.81|1.02|||ANCOVA|||||1.02|0.81|
70960231|NCT01257425|141424964|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.85|TWO_SIDED|95.0|-0.09|0.11|||ANCOVA|||||0.11|-0.09|0.85
70960232|NCT01257425|141424965|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||Log Rank|||||||0.98
70960233|NCT01257425|141424966|SUPERIORITY_OR_OTHER|||||||0.84|||||||Log Rank|||||||0.84
70960234|NCT02668185|141424967|SUPERIORITY|Generalised linear mixed model with a Poisson error structure|Mean Difference (Net)|29.66|||<|0.0001|TWO_SIDED|95.0|17.39|42.87||Intention to treat adjusted means.|generalised linear mixed model with a Po|Adjusted for intention to treat||||42.87|17.39|<0.0001
70960235|NCT02668185|141424968|SUPERIORITY||Mean Difference (Net)|50.0|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
70960236|NCT02668185|141424969|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
70960237|NCT02668185|141424970|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
70960238|NCT02668185|141424971|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
70960239|NCT00883051|141425009|OTHER|A hierarchical test procedure was applied only for analysis of the primary efficacy endpoint.|||||<|0.0001|||||||Cochran-Armitage test for trend|||||||<0.0001
70960240|NCT00883051|141425010|OTHER|A hierarchical test procedure was applied only for analysis of the primary efficacy endpoint.|||||=|0.0006|||||||Cochran-Armitage test for trend]|||||||=0.0006
70880580|NCT00663052|141245999|SUPERIORITY_OR_OTHER||Proportion difference|14.38||||0.001|TWO_SIDED|95.0|5.39|23.37|||Fisher Exact|||Comparison between treatment groups at Week 16||23.37|5.39|0.0010
70960241|NCT02618642|141425033|SUPERIORITY|||||||0.3879|||||||Wilcoxon (Mann-Whitney)|||the results in the irradiated group (n=45) and the control group (n=15) were compared||||0.3879
70960242|NCT02618642|141425033|SUPERIORITY|||||||0.5361|||||||Kruskal-Wallis|||comparison was conducted of the results obtained with a different filter were compared||||0.5361
70960243|NCT02618642|141425034|SUPERIORITY|||||||0.4669|||||||Wilcoxon (Mann-Whitney)|||the results in the irradiated group (n=45) vs the control group (placebo) (n=15) were compared.||||0.4669
70960244|NCT02618642|141425034|SUPERIORITY|||||||0.4161|||||||Kruskal-Wallis|||||||0.4161
70960245|NCT02618642|141425035|SUPERIORITY|||||||0.9596|||||||Wilcoxon (Mann-Whitney)|||the results in the irradiated group (n=45) and the control group (n=15) were compared.||||0.9596
70960246|NCT02618642|141425035|SUPERIORITY|||||||0.0907|||||||Kruskal-Wallis|||||||0.0907
70960247|NCT02618642|141425036|SUPERIORITY|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||the results in the irradiated group (n=45) and the control group (n=15) were compared.||||0.0110
70960248|NCT02618642|141425036|SUPERIORITY|||||||0.1165|||||||Kruskal-Wallis|||comparison was conducted of the results obtained with a different filter (groups v, x, y,||||0.1165
70960249|NCT02618642|141425037|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||he results in the irradiated group (n=45) and the control group (n=15) were compared||||0.0200
70960250|NCT02618642|141425037|SUPERIORITY|comparison was conducted of the results obtained with a different filter (groups v, x, y,||||||0.0014|||||||Kruskal-Wallis|||||||0.0014
70960251|NCT01078220|141425060|SUPERIORITY_OR_OTHER||Relative Risk|6.0|||||TWO_SIDED|95.0|3.91|9.21|||unconditional logistic regression||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.|||9.21|3.91|
70960252|NCT01078220|141425060|SUPERIORITY_OR_OTHER||Relative Risk|2.88|||||TWO_SIDED|95.0|1.18|7.08|||unconditional logistic regression||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.|||7.08|1.18|
70960253|NCT01078220|141425064|SUPERIORITY_OR_OTHER||Relative Risk|1.64|||||TWO_SIDED|95.0|1.17|2.3|||unconditional logistic regression||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.|Days 1-14 after vaccination.||2.3|1.17|
70960254|NCT01078220|141425064|SUPERIORITY_OR_OTHER||Relative Risk|1.05|||||TWO_SIDED|95.0|0.82|1.35|||unconditional logistic regression||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.|Days 1-60 after vaccination.||1.35|0.82|
70960255|NCT01078220|141425064|SUPERIORITY_OR_OTHER||Relative Risk|1.02|||||TWO_SIDED|95.0|0.53|1.98|||unconditional logistic regression||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.|Days 1-14 after vaccination.||1.98|0.53|
70960256|NCT01078220|141425064|SUPERIORITY_OR_OTHER||Relative Risk|0.78|||||TWO_SIDED|95.0|0.5|1.21|||unconditional logistic regression||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.|Days 1-60 after vaccination.||1.21|0.5|
70960257|NCT03824639|141425065|OTHER|Cohen's d will be used to estimate the effect size for comparing change in outcome measurements over 6 months in the exercise group to the control group. This effect size will be used for sample size calculations.|Cohen's d|0.37|||||TWO_SIDED|||||||||||||
70960258|NCT03824639|141425066|OTHER|Cohen's d will be used to estimate the effect size for comparing change in outcome measurements over 6 months in the exercise group to the control group. This effect size will be used for sample size calculations.|Cohen's d|0.18|||||TWO_SIDED|||||||||||||
70960259|NCT01620255|141425081|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.08||||0.0213|TWO_SIDED|90.0|0.019|0.14||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg versus (vs) placebo, centrally read||0.140|0.019|0.0213
70960260|NCT01620255|141425081|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.128||||0.0025|TWO_SIDED|90.0|0.056|0.199||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, centrally read||0.199|0.056|0.0025
70960261|NCT01620255|141425081|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.118||||0.004|TWO_SIDED|90.0|0.048|0.188||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, centrally read||0.188|0.048|0.0040
70960262|NCT01620255|141425081|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.026||||0.1803|TWO_SIDED|90.0|-0.012|0.064||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, centrally read||0.064|-0.012|0.1803
70960263|NCT01620255|141425081|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.08||||0.0582|TWO_SIDED|90.0|0.002|0.159||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo, locally read||0.159|0.002|0.0582
70960264|NCT01620255|141425081|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.178||||0.0014|TWO_SIDED|90.0|0.083|0.272||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, locally read||0.272|0.083|0.0014
70960265|NCT01620255|141425081|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.122||||0.0125|TWO_SIDED|90.0|0.036|0.208||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, locally read||0.208|0.036|0.0125
70960266|NCT01620255|141425081|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.066||||0.0927|TWO_SIDED|90.0|-0.009|0.142||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, locally read||0.142|-0.009|0.0927
70960267|NCT01620255|141425082|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.089||||0.1379|TWO_SIDED|90.0|-0.037|0.214||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo, centrally read||0.214|-0.037|0.1379
70960268|NCT01620255|141425082|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.254||||0.0011|TWO_SIDED|90.0|0.121|0.388||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, centrally read||0.388|0.121|0.0011
70960269|NCT01620255|141425082|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.163||||0.0239|TWO_SIDED|90.0|0.032|0.293||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, centrally read||0.293|0.032|0.0239
70960270|NCT01620255|141425082|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.213||||0.0052|TWO_SIDED|90.0|0.08|0.347||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, centrally read||0.347|0.080|0.0052
70960271|NCT01620255|141425082|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.056||||0.2617|TWO_SIDED|90.0|-0.075|0.186||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo, locally read||0.186|-0.075|0.2617
70960272|NCT01620255|141425082|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.212||||0.0058|TWO_SIDED|90.0|0.077|0.347||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, locally read||0.347|0.077|0.0058
70960273|NCT01620255|141425082|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.156||||0.0326|TWO_SIDED|90.0|0.022|0.29||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, locally read||0.290|0.022|0.0326
70960274|NCT01620255|141425082|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.185||||0.0145|TWO_SIDED|90.0|0.05|0.32||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, locally read||0.320|0.050|0.0145
70960275|NCT01620255|141425083|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.081||||0.0618|TWO_SIDED|90.0|0.0|0.162||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo, centrally read||0.162|0.000|0.0618
70960276|NCT01620255|141425083|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.187||||0.0009|TWO_SIDED|90.0|0.091|0.284||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, centrally read||0.284|0.091|0.0009
70960277|NCT01620255|141425083|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.159||||0.0027|TWO_SIDED|90.0|0.068|0.25||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, centrally read||0.250|0.068|0.0027
70960278|NCT01620255|141425083|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.069||||0.0999|TWO_SIDED|90.0|-0.013|0.151||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, centrally read||0.151|-0.013|0.0999
70960279|NCT01620255|141425083|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.001||||0.5225|TWO_SIDED|90.0|-0.111|0.114||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo, locally read||0.114|-0.111|0.5225
70960280|NCT01620255|141425083|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.154||||0.0246|TWO_SIDED|90.0|0.03|0.278||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, locally read||0.278|0.030|0.0246
70960281|NCT01620255|141425083|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.13||||0.0464|TWO_SIDED|90.0|0.008|0.253||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, locally read||0.253|0.008|0.0464
70960282|NCT01620255|141425083|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.066||||0.2|TWO_SIDED|90.0|-0.053|0.186||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, locally read||0.186|-0.053|0.2000
70960283|NCT01620255|141425085|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean (LSM) Difference|-0.88||||0.0494|TWO_SIDED|90.0|-1.623|-0.145|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 7.5 mg vs placebo, centrally read change||-0.145|-1.623|0.0494
70960284|NCT01620255|141425085|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.53||||0.0005|TWO_SIDED|90.0|-2.254|-0.809|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 22.5 mg vs placebo, centrally read change||-0.809|-2.254|0.0005
70960285|NCT01620255|141425085|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.12||||0.0117|TWO_SIDED|90.0|-1.845|-0.39|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 75 mg vs placebo, centrally read change||-0.390|-1.845|0.0117
70960286|NCT01620255|141425085|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.27||||0.0049|TWO_SIDED|90.0|-2.016|-0.533|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 225 mg vs placebo, centrally read change||-0.533|-2.016|0.0049
70960287|NCT01620255|141425085|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.94||||0.0543|TWO_SIDED|90.0|-1.737|-0.137|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 7.5 mg vs placebo, locally read change||-0.137|-1.737|0.0543
70960288|NCT01620255|141425085|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.6||||0.0008|TWO_SIDED|90.0|-2.372|-0.819|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 22.5 mg vs placebo, locally read change||-0.819|-2.372|0.0008
70960289|NCT01620255|141425085|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.07||||0.0255|TWO_SIDED|90.0|-1.858|-0.284|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 75 mg vs placebo, locally read change||-0.284|-1.858|0.0255
70960290|NCT01620255|141425085|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.29||||0.0079|TWO_SIDED|90.0|-2.082|-0.493|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 225 mg vs placebo, locally read change||-0.493|-2.082|0.0079
70960291|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.25||||0.1016|TWO_SIDED|90.0|-0.511|0.001|||Mixed Models Analysis|Linear Mixed Model (LMM) with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Stool Frequency, W4||0.001|-0.511|0.1016
70960292|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.28||||0.0654|TWO_SIDED|90.0|-0.529|-0.03|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Stool Frequency, W4||-0.030|-0.529|0.0654
70960293|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.22||||0.15|TWO_SIDED|90.0|-0.472|0.031|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Stool Frequency, W4||0.031|-0.472|0.1500
70960294|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.38||||0.0132|TWO_SIDED|90.0|-0.637|-0.129|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Stool Frequency, W4||-0.129|-0.637|0.0132
70960295|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.3||||0.0526|TWO_SIDED|90.0|-0.555|-0.046|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Stool Frequency, W8||-0.046|-0.555|0.0526
70960296|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.31||||0.0422|TWO_SIDED|90.0|-0.554|-0.058|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Stool Frequency, W8||-0.058|-0.554|0.0422
70960297|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.39||||0.011|TWO_SIDED|90.0|-0.637|-0.137|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Stool Frequency, W8||-0.137|-0.637|0.0110
70960298|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.5||||0.001|TWO_SIDED|90.0|-0.755|-0.254|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Stool Frequency, W8||-0.254|-0.755|0.0010
70960299|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.22||||0.1611|TWO_SIDED|90.0|-0.475|0.038|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Stool Frequency, W12||0.038|-0.475|0.1611
70960300|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.36||||0.0186|TWO_SIDED|90.0|-0.608|-0.108|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Stool Frequency, W12||-0.108|-0.608|0.0186
70960301|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.21||||0.1647|TWO_SIDED|90.0|-0.465|0.039|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Stool Frequency, W12||0.039|-0.465|0.1647
70960302|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.35||||0.0231|TWO_SIDED|90.0|-0.607|-0.097|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Stool Frequency, W12||-0.097|-0.607|0.0231
70960303|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.46||||0.0002|TWO_SIDED|90.0|-0.658|-0.26|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Rectal Bleeding, W4||-0.260|-0.658|0.0002
70960304|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.52|||<|0.0001|TWO_SIDED|90.0|-0.71|-0.322|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Rectal Bleeding, W4||-0.322|-0.710|<0.0001
70960305|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.49|||<|0.0001|TWO_SIDED|90.0|-0.686|-0.295|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Rectal Bleeding, W4||-0.295|-0.686|<0.0001
70960306|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.39||||0.0012|TWO_SIDED|90.0|-0.587|-0.192|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Rectal Bleeding, W4||-0.192|-0.587|0.0012
70960307|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.28||||0.0207|TWO_SIDED|90.0|-0.475|-0.081|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Rectal Bleeding, W8||-0.081|-0.475|0.0207
70960308|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.24||||0.0402|TWO_SIDED|90.0|-0.432|-0.048|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Rectal Bleeding, W8||-0.048|-0.432|0.0402
70960309|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.32||||0.0071|TWO_SIDED|90.0|-0.511|-0.124|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Rectal Bleeding, W8||-0.124|-0.511|0.0071
70960310|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.47|||<|0.0001|TWO_SIDED|90.0|-0.664|-0.275|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Rectal Bleeding, W8||-0.275|-0.664|<0.0001
70960311|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.25||||0.0395|TWO_SIDED|90.0|-0.449|-0.05|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Rectal Bleeding, W12||-0.050|-0.449|0.0395
70960312|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.32||||0.0073|TWO_SIDED|90.0|-0.511|-0.123|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Rectal Bleeding, W12||-0.123|-0.511|0.0073
70880581|NCT00663052|141245999|SUPERIORITY_OR_OTHER||Proportion difference|10.75||||0.0087|TWO_SIDED|95.0|2.35|19.16|||Fisher Exact|||Comparison between treatment groups at Week 20||19.16|2.35|0.0087
70960313|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.24||||0.0413|TWO_SIDED|90.0|-0.439|-0.047|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Rectal Bleeding, W12||-0.047|-0.439|0.0413
70960314|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.4||||0.0008|TWO_SIDED|90.0|-0.602|-0.206|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Rectal Bleeding, W12||-0.206|-0.602|0.0008
70960315|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.19||||0.1862|TWO_SIDED|90.0|-0.421|0.046|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, PGA, W4||0.046|-0.421|0.1862
70960316|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.23||||0.0998|TWO_SIDED|90.0|-0.455|0.0|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, PGA, W4||-0.000|-0.455|0.0998
70960317|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.22||||0.1085|TWO_SIDED|90.0|-0.453|0.006|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, PGA, W4||0.006|-0.453|0.1085
70960318|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.14||||0.3161|TWO_SIDED|90.0|-0.372|0.09|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, PGA, W4||0.090|-0.372|0.3161
70960319|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.1||||0.4962|TWO_SIDED|90.0|-0.328|0.136|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, PGA, W8||0.136|-0.328|0.4962
70960320|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.29||||0.0371|TWO_SIDED|90.0|-0.512|-0.06|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, PGA, W8||-0.060|-0.512|0.0371
70960321|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.21||||0.1212|TWO_SIDED|90.0|-0.441|0.013|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, PGA, W8||0.013|-0.441|0.1212
70960322|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.18||||0.187|TWO_SIDED|90.0|-0.41|0.045|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, PGA, W8||0.045|-0.410|0.1870
70960323|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.23||||0.1133|TWO_SIDED|90.0|-0.459|0.009|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, PGA, W12||0.009|-0.459|0.1133
70960324|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.43||||0.0022|TWO_SIDED|90.0|-0.653|-0.198|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, PGA, W12||-0.198|-0.653|0.0022
70960325|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.25||||0.0788|TWO_SIDED|90.0|-0.475|-0.016|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, PGA, W12||-0.016|-0.475|0.0788
70960326|NCT01620255|141425086|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.25||||0.0717|TWO_SIDED|90.0|-0.485|-0.022|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, PGA, W12||-0.022|-0.485|0.0717
70960327|NCT01620255|141425087|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.08||||0.5406|TWO_SIDED|90.0|-0.286|0.131|||ANCOVA|ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo||0.131|-0.286|0.5406
70960328|NCT01620255|141425087|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.42||||0.0007|TWO_SIDED|90.0|-0.628|-0.221|||ANCOVA|ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo||-0.221|-0.628|0.0007
70960329|NCT01620255|141425087|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.34||||0.0063|TWO_SIDED|90.0|-0.549|-0.137|||ANCOVA|ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.||PF-00547659 75 mg vs placebo||-0.137|-0.549|0.0063
70960330|NCT01620255|141425087|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.23||||0.0748|TWO_SIDED|90.0|-0.436|-0.018|||ANCOVA|ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.||PF-00547659 225 mg vs placebo||-0.018|-0.436|0.0748
70960331|NCT01620255|141425088|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.9||||0.9744|TWO_SIDED|90.0|-101.0|97.14|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 4||97.14|-101.00|0.9744
70960332|NCT01620255|141425088|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|74.9||||0.2023|TWO_SIDED|90.0|-21.77|171.66|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 4||171.66|-21.77|0.2023
70960333|NCT01620255|141425088|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|32.9||||0.5808|TWO_SIDED|90.0|-65.09|130.79|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Week 4||130.79|-65.09|0.5808
70960334|NCT01620255|141425088|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|37.6||||0.5388|TWO_SIDED|90.0|-63.12|138.34|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 4||138.34|-63.12|0.5388
70960335|NCT01620255|141425088|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-8.2||||0.8902|TWO_SIDED|90.0|-106.24|89.81|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 8||89.81|-106.24|0.8902
70960336|NCT01620255|141425088|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|10.2||||0.8616|TWO_SIDED|90.0|-86.14|106.54|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 8||106.54|-86.14|0.8616
70960337|NCT01620255|141425088|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-34.3||||0.5684|TWO_SIDED|90.0|-133.49|64.79|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Week 8||64.79|-133.49|0.5684
70960338|NCT01620255|141425088|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|33.8||||0.57|TWO_SIDED|90.0|-64.2|131.86|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 8||131.86|-64.20|0.5700
70960339|NCT01620255|141425088|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-30.0||||0.6234|TWO_SIDED|90.0|-130.56|70.57|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 12||70.57|-130.56|0.6234
70960340|NCT01620255|141425088|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|36.0||||0.5474|TWO_SIDED|90.0|-62.44|134.38|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 12||134.38|-62.44|0.5474
70960341|NCT01620255|141425088|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|78.5||||0.1918|TWO_SIDED|90.0|-20.48|177.56|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo,Week 12||177.56|-20.48|0.1918
70960342|NCT01620255|141425088|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-3.0||||0.9615|TWO_SIDED|90.0|-104.88|98.91|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 12||98.91|-104.88|0.9615
70960343|NCT01620255|141425089|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|6.4||||0.9328|TWO_SIDED|90.0|-118.6|131.41|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 4||131.41|-118.60|0.9328
70960344|NCT01620255|141425089|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-9.8||||0.8962|TWO_SIDED|90.0|-132.91|113.39|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 4||113.39|-132.91|0.8962
70960345|NCT01620255|141425089|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|11.5||||0.8775|TWO_SIDED|90.0|-110.83|133.74|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Week 4||133.74|-110.83|0.8775
70880582|NCT00663052|141245999|SUPERIORITY_OR_OTHER||Proportion difference|11.46||||0.0068|TWO_SIDED|95.0|2.77|20.15|||Fisher Exact|||Comparison between treatment groups at Week 24||20.15|2.77|0.0068
70880583|NCT00663052|141246000|SUPERIORITY_OR_OTHER||Proportion difference|1.5||||0.2435|TWO_SIDED|95.0|-1.31|4.32|||Fisher Exact|||Comparison between treatment groups at Week 2||4.32|-1.31|0.2435
70960346|NCT01620255|141425089|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-17.0||||0.8224|TWO_SIDED|90.0|-142.02|107.94|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 4||107.94|-142.02|0.8224
70960347|NCT01620255|141425089|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-52.7||||0.4831|TWO_SIDED|90.0|-176.48|71.02|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 8||71.02|-176.48|0.4831
70960348|NCT01620255|141425089|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-115.2||||0.1183|TWO_SIDED|90.0|-236.63|6.13|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 8||6.13|-236.63|0.1183
70960349|NCT01620255|141425089|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-115.8||||0.1139|TWO_SIDED|90.0|-236.29|4.69|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Week 8||4.69|-236.29|0.1139
70880584|NCT00663052|141246000|SUPERIORITY_OR_OTHER||Proportion difference|1.64||||0.5929|TWO_SIDED|95.0|-4.4|7.67|||Fisher Exact|||Comparison between treatment groups at Week 4||7.67|-4.40|0.5929
70880585|NCT00663052|141246000|SUPERIORITY_OR_OTHER||Proportion difference|13.44||||0.0156|TWO_SIDED|95.0|2.02|24.86|||Fisher Exact|||Comparison between treatment groups at Week 8||24.86|2.02|0.0156
70880586|NCT00663052|141246000|SUPERIORITY_OR_OTHER||Proportion difference|25.18|||<|0.0001|TWO_SIDED|95.0|12.89|37.47|||Fisher Exact|||Comparison between treatment groups at Week 12||37.47|12.89|<.0001
70960350|NCT01620255|141425089|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-96.4||||0.1931|TWO_SIDED|90.0|-218.17|25.46|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 8||25.46|-218.17|0.1931
70960351|NCT01620255|141425089|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-119.7||||0.1182|TWO_SIDED|90.0|-245.66|6.32|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 12||6.32|-245.66|0.1182
70960352|NCT01620255|141425089|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-41.7||||0.5784|TWO_SIDED|90.0|-165.34|81.87|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 12||81.87|-165.34|0.5784
70960353|NCT01620255|141425089|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-163.6||||0.0279|TWO_SIDED|90.0|-285.84|-41.29|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo,Week 12||-41.29|-285.84|0.0279
70960354|NCT01620255|141425089|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-123.5||||0.1053|TWO_SIDED|90.0|-249.0|1.93|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 12||1.93|-249.00|0.1053
70960355|NCT01620255|141425090|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.1||||0.8302|TWO_SIDED|90.0|-9.507|7.317|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, change from BL at W12||7.317|-9.507|0.8302
70960356|NCT01620255|141425090|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|12.33||||0.0141|TWO_SIDED|90.0|4.084|20.567|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, change from BL at W12||20.567|4.084|0.0141
70960357|NCT01620255|141425090|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|11.7||||0.0182|TWO_SIDED|90.0|3.564|19.84|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, change from BL at W12||19.840|3.564|0.0182
70960358|NCT01620255|141425090|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|15.48||||0.0026|TWO_SIDED|90.0|7.056|23.907|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, change from BL at W12||23.907|7.056|0.0026
70960359|NCT01620255|141425091|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.73||||0.6862|TWO_SIDED|90.0|-3.689|2.235|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, bowel fx change from BL at W12||2.235|-3.689|0.6862
70960360|NCT01620255|141425091|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|4.37||||0.0135|TWO_SIDED|90.0|1.467|7.28|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, bowel fx change from BL at W12||7.280|1.467|0.0135
70960361|NCT01620255|141425091|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|4.16||||0.0171|TWO_SIDED|90.0|1.293|7.023|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, bowel fx change from BL at W12||7.023|1.293|0.0171
70960362|NCT01620255|141425091|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|5.2||||0.0041|TWO_SIDED|90.0|2.232|8.172|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, bowel fx change from BL at W12||8.172|2.232|0.0041
70960363|NCT01620255|141425091|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|0.22||||0.9072|TWO_SIDED|90.0|-2.897|3.339|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, emotional fx change from BL at W12||3.339|-2.897|0.9072
70960364|NCT01620255|141425091|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|4.47||||0.0161|TWO_SIDED|90.0|1.42|7.522|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, emotional fx change from BL at W12||7.522|1.420|0.0161
70960365|NCT01620255|141425091|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|4.06||||0.0271|TWO_SIDED|90.0|1.042|7.071|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, emotional fx change from BL at W12||7.071|1.042|0.0271
70960366|NCT01620255|141425091|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|5.9||||0.002|TWO_SIDED|90.0|2.778|9.026|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, emotional fx change from BL at W12||9.026|2.778|0.0020
70880587|NCT00663052|141246000|SUPERIORITY_OR_OTHER||Proportion difference|21.84||||0.0003|TWO_SIDED|95.0|9.82|33.85|||Fisher Exact|||Comparison between treatment groups at Week 16||33.85|9.82|0.0003
70960367|NCT01620255|141425091|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.26||||0.7711|TWO_SIDED|90.0|-1.756|1.229|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, systemic symptoms change from BL at W12||1.229|-1.756|0.7711
70960368|NCT01620255|141425091|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|1.69||||0.0582|TWO_SIDED|90.0|0.223|3.147|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, systemic symptoms change from BL at W12||3.147|0.223|0.0582
70960369|NCT01620255|141425091|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|1.68||||0.0558|TWO_SIDED|90.0|0.235|3.12|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, systemic symptoms change from BL at W12||3.120|0.235|0.0558
70960370|NCT01620255|141425091|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|1.66||||0.0686|TWO_SIDED|90.0|0.161|3.153|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, systemic symptoms change from BL at W12||3.153|0.161|0.0686
70960371|NCT01620255|141425091|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.33||||0.7561|TWO_SIDED|90.0|-2.094|1.429|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, social fx change from BL at W12||1.429|-2.094|0.7561
70960372|NCT01620255|141425091|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|2.17||||0.0384|TWO_SIDED|90.0|0.447|3.891|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, social fx change from BL at W12||3.891|0.447|0.0384
70960373|NCT01620255|141425091|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|1.86||||0.0729|TWO_SIDED|90.0|0.154|3.557|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, social fx change from BL at W12||3.557|0.154|0.0729
70960374|NCT01620255|141425091|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|2.95||||0.006|TWO_SIDED|90.0|1.19|4.715|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, social fx change from BL at W12||4.715|1.190|0.0060
70960375|NCT01620255|141425092|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-0.002||||0.5201|TWO_SIDED|90.0|-0.145|0.142||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo||0.142|-0.145|0.5201
70960376|NCT01620255|141425092|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.183||||0.0217|TWO_SIDED|90.0|0.039|0.328||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo||0.328|0.039|0.0217
70960377|NCT01620255|141425092|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.096||||0.1473|TWO_SIDED|90.0|-0.045|0.237||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo||0.237|-0.045|0.1473
70960378|NCT01620255|141425092|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.112||||0.1231|TWO_SIDED|90.0|-0.038|0.261||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo||0.261|-0.038|0.1231
70960379|NCT03794908|141425096|SUPERIORITY||Mean Difference (Net)|3.8|STANDARD_ERROR_OF_MEAN|3.49||0.28|TWO_SIDED|95.0|-3.03|10.64|||Mixed Models Analysis|The comparison was done using a mixed model with assessments at 3 time points (pre-treatment, mid-treatment, and end of treatment).||Test of between-arm difference at mid-treatment.||10.64|-3.03|0.28
70960380|NCT03794908|141425096|SUPERIORITY||Mean Difference (Net)|4.48|STANDARD_ERROR_OF_MEAN|3.53||0.21|TWO_SIDED|95.0|-2.44|11.4|||Mixed Models Analysis|The comparison was done using a mixed model with assessments at 3 time points (pre-treatment, mid-treatment, and end of treatment).||Test of between-arm difference at end of treatment.||11.40|-2.44|0.21
70960381|NCT04256603|141425106|OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||wilcox two sample test||||0.67
70960382|NCT04981366|141425110|SUPERIORITY|||||||0.013|TWO_SIDED|95.0||||We applied the restricted maximum likelihood, compound symmetry covariance structure, and Kenward-Roger degrees of freedom approximation. To maintain the significance level at 0.05, the primary endpoints were assessed using Hochberg's procedure.|Mixed Models Analysis|||||||0.013
70960383|NCT04981366|141425111|SUPERIORITY||||||<|0.001||||||We applied the restricted maximum likelihood, compound symmetry covariance structure, and Kenward-Roger degrees of freedom approximation. To maintain the significance level at 0.05, the primary endpoints were assessed using Hochberg's procedure.|Mixed Models Analysis|||||||<0.001
70960384|NCT04981366|141425112|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70880588|NCT00663052|141246000|SUPERIORITY_OR_OTHER||Proportion difference|19.8||||0.0006|TWO_SIDED|95.0|8.23|31.38|||Fisher Exact|||Comparison between treatment groups at Week 20||31.38|8.23|0.0006
70960385|NCT04981366|141425113|SUPERIORITY|||||||0.007||||||We applied the restricted maximum likelihood, compound symmetry covariance structure, and Kenward-Roger degrees of freedom approximation. To maintain the significance level at 0.05, the primary endpoints were assessed using Hochberg's procedure.|Mixed Models Analysis|||||||0.007
70960386|NCT04981366|141425114|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70960387|NCT04981366|141425115|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70960388|NCT04981366|141425116|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|||||||0.005
70960389|NCT04981366|141425117|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70960390|NCT04981366|141425118|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70960391|NCT04981366|141425119|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70960392|NCT04981366|141425120|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70960393|NCT04981366|141425121|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
70960394|NCT04981366|141425122|SUPERIORITY|||||||0.033|||||||Mixed Models Analysis|||||||0.033
70960395|NCT04981366|141425123|SUPERIORITY|||||||0.944|||||||Mixed Models Analysis|||||||0.944
70960396|NCT04981366|141425124|SUPERIORITY|||||||0.203|||||||Mixed Models Analysis|||||||0.203
70960397|NCT04981366|141425125|SUPERIORITY|||||||0.027|||||||Mixed Models Analysis|||||||0.027
70960398|NCT04981366|141425126|SUPERIORITY|||||||0.145|||||||Mixed Models Analysis|||||||0.145
70960399|NCT04981366|141425127|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
70960400|NCT04981366|141425128|SUPERIORITY|||||||0.551|||||||Mixed Models Analysis|||||||0.551
70960401|NCT04981366|141425129|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
70960402|NCT04981366|141425130|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
70960403|NCT04981366|141425131|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
70960404|NCT04981366|141425132|SUPERIORITY|||||||0.008|||||||Mixed Models Analysis|||||||0.008
70960405|NCT04981366|141425133|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70960406|NCT04981366|141425134|SUPERIORITY|||||||0.344|||||||Mixed Models Analysis|||||||0.344
70960407|NCT04981366|141425135|SUPERIORITY|||||||0.613|||||||Mixed Models Analysis|||||||0.613
70880589|NCT00663052|141246000|SUPERIORITY_OR_OTHER||Proportion difference|18.34||||0.0015|TWO_SIDED|95.0|6.8|29.88|||Fisher Exact|||Comparison between treatment groups at Week 24||29.88|6.80|0.0015
70960408|NCT04981366|141425136|SUPERIORITY|||||||0.944|||||||Mixed Models Analysis|||||||0.944
70960409|NCT04981366|141425137|SUPERIORITY|||||||0.601|||||||Mixed Models Analysis|||||||0.601
70960410|NCT04981366|141425138|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70960411|NCT04981366|141425139|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70960412|NCT04981366|141425140|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70960413|NCT04981366|141425142|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70960414|NCT04981366|141425143|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70960415|NCT04981366|141425144|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70960416|NCT04981366|141425145|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70960417|NCT04981366|141425146|SUPERIORITY|||||||0.017|||||||Mixed Models Analysis|||||||0.017
70960418|NCT04981366|141425147|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70960419|NCT04981366|141425148|SUPERIORITY|||||||0.949|||||||Mixed Models Analysis|||||||0.949
70960420|NCT04981366|141425149|SUPERIORITY|||||||0.993|||||||Mixed Models Analysis|||||||0.993
70960421|NCT04981366|141425150|SUPERIORITY|||||||0.601|||||||Mixed Models Analysis|||||||0.601
70960422|NCT04981366|141425151|SUPERIORITY|||||||0.408|||||||Mixed Models Analysis|||||||0.408
70960423|NCT04981366|141425152|SUPERIORITY|||||||0.082|||||||Mixed Models Analysis|||||||0.082
70960424|NCT04981366|141425153|SUPERIORITY|||||||0.55|||||||Mixed Models Analysis|||||||0.550
70960425|NCT04981366|141425154|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|||||||0.700
70960426|NCT04981366|141425155|SUPERIORITY|||||||0.254|||||||Mixed Models Analysis|||||||0.254
70960427|NCT04981366|141425156|SUPERIORITY|||||||0.373|||||||Mixed Models Analysis|||||||0.373
70960428|NCT04981366|141425157|SUPERIORITY|||||||0.407|||||||Mixed Models Analysis|||||||0.407
70960429|NCT04981366|141425158|SUPERIORITY|||||||0.051|||||||Mixed Models Analysis|||||||0.051
70960430|NCT04981366|141425159|SUPERIORITY|||||||0.385|||||||Mixed Models Analysis|||||||0.385
70960431|NCT04981366|141425160|SUPERIORITY|||||||0.239|||||||Mixed Models Analysis|||||||0.239
70960432|NCT04981366|141425161|SUPERIORITY|||||||0.463|||||||Mixed Models Analysis|||||||0.463
70960433|NCT04981366|141425162|SUPERIORITY|||||||0.032|||||||Mixed Models Analysis|||||||0.032
70960434|NCT04981366|141425163|SUPERIORITY|||||||0.469|||||||Mixed Models Analysis|||||||0.469
70960435|NCT04981366|141425164|SUPERIORITY|||||||0.013|||||||Mixed Models Analysis|||||||0.013
70960436|NCT04981366|141425165|SUPERIORITY|||||||0.064|||||||Mixed Models Analysis|||||||0.064
70960437|NCT04981366|141425166|SUPERIORITY|||||||0.0314|||||||Mixed Models Analysis|||||||0.0314
70960438|NCT04981366|141425167|SUPERIORITY|||||||0.0147|||||||Mixed Models Analysis|||||||0.0147
70960439|NCT04981366|141425168|SUPERIORITY|||||||0.007|||||||Mixed Models Analysis|||||||0.007
70960440|NCT04981366|141425169|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70960441|NCT04981366|141425170|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
70960442|NCT01122862|141425177|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21||||0.0915|TWO_SIDED|95.0|-0.45|0.03||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||0.03|-0.45|0.0915
70880590|NCT00663052|141246001|SUPERIORITY_OR_OTHER||Proportion difference|0.0|||||TWO_SIDED|95.0|-0.74|0.74||The P-value at Week 2 was not applicable as the percentage of participants achieving 90% improvement in PASI in both treatment groups were 0%.|Fisher Exact|||Comparison between treatment groups at Week 2||0.74|-0.74|
70880591|NCT00663052|141246001|SUPERIORITY_OR_OTHER||Proportion difference|0.02||||1|TWO_SIDED|95.0|-2.77|2.81|||Fisher Exact|||Comparison between treatment groups at Week 4||2.81|-2.77|1.0000
70880592|NCT00663052|141246001|SUPERIORITY_OR_OTHER||Proportion difference|3.94||||0.2611|TWO_SIDED|95.0|-3.2|11.07|||Fisher Exact|||Comparison between treatment groups at Week 8||11.07|-3.20|0.2611
70880593|NCT00663052|141246001|SUPERIORITY_OR_OTHER||Proportion difference|18.37||||0.0002|TWO_SIDED|95.0|8.3|28.45|||Fisher Exact|||Comparison between treatment groups at Week 12||28.45|8.30|0.0002
70880594|NCT00663052|141246001|SUPERIORITY_OR_OTHER||Proportion difference|17.31||||0.0031|TWO_SIDED|95.0|5.43|29.19|||Fisher Exact|||Comparison between treatment groups at Week 16||29.19|5.43|0.0031
70880595|NCT00663052|141246001|SUPERIORITY_OR_OTHER||Proportion difference|15.92||||0.0081|TWO_SIDED|95.0|3.8|28.04|||Fisher Exact|||Comparison between treatment groups at Week 20||28.04|3.80|0.0081
70880596|NCT00663052|141246001|SUPERIORITY_OR_OTHER||Proportion difference|16.78||||0.0064|TWO_SIDED|95.0|4.46|29.1|||Fisher Exact|||Comparison between treatment groups at Week 24||29.10|4.46|0.0064
70960443|NCT01122862|141425178|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.66|||<|0.0001|TWO_SIDED|95.0|1.42|1.9||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference in treatments being compared.||1.90|1.42|<0.0001
70960444|NCT01122862|141425179|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.04||||0.6682|TWO_SIDED|95.0|-0.14|0.21|||ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||0.21|-0.14|0.6682
70880597|NCT00663052|141246002|SUPERIORITY_OR_OTHER||Proportion difference|0.0|||||TWO_SIDED|95.0|-0.74|0.74||The P-value at Week 2 was to be calculated by Fisher Exact method but was not estimable as the percentage of participants achieving 100% improvement in PASI in both treatment groups were 0%.||||Comparison between treatment groups at Week 2||0.74|-0.74|
70880598|NCT00663052|141246002|SUPERIORITY_OR_OTHER||Proportion difference|-0.73||||1|TWO_SIDED|95.0|-2.9|1.44|||Fisher Exact|||Comparison between treatment groups at Week 4||1.44|-2.90|1.0000
70880599|NCT00663052|141246002|SUPERIORITY_OR_OTHER||Proportion difference|-1.46||||0.4983|TWO_SIDED|95.0|-4.21|1.29|||Fisher Exact|||Comparison between treatment groups at Week 8||1.29|-4.21|0.4983
70880600|NCT00663052|141246002|SUPERIORITY_OR_OTHER||Proportion difference|1.57||||0.4957|TWO_SIDED|95.0|-3.23|6.37|||Fisher Exact|||Comparison between treatment groups at Week 12||6.37|-3.23|0.4957
70880601|NCT00663052|141246002|SUPERIORITY_OR_OTHER||Proportion difference|3.14||||0.3115|TWO_SIDED|95.0|-3.24|9.52|||Fisher Exact|||Comparison between treatment groups at Week 16||9.52|-3.24|0.3115
70880602|NCT00663052|141246002|SUPERIORITY_OR_OTHER||Proportion difference|6.99||||0.0773|TWO_SIDED|95.0|-1.13|15.1|||Fisher Exact|||Comparison between treatment groups at Week 20||15.10|-1.13|0.0773
70880603|NCT00663052|141246002|SUPERIORITY_OR_OTHER||Proportion difference|5.53||||0.183|TWO_SIDED|95.0|-2.82|13.87|||Fisher Exact|||Comparison between treatment groups at Week 24||13.87|-2.82|0.1830
70880604|NCT00663052|141246003|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-1.3||||0.0103|TWO_SIDED|95.0|-2.3|-0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2||-0.3|-2.3|0.0103
70880605|NCT00663052|141246003|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-1.8||||0.0031|TWO_SIDED|95.0|-3.0|-0.6|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4||-0.6|-3.0|0.0031
70880606|NCT00663052|141246003|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-3.0|||<|0.0001|TWO_SIDED|95.0|-4.4|-1.7|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8||-1.7|-4.4|<0.0001
70880607|NCT00663052|141246003|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-3.6|||<|0.0001|TWO_SIDED|95.0|-5.0|-2.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||-2.2|-5.0|<0.0001
70880608|NCT00663052|141246003|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-2.8|||<|0.0001|TWO_SIDED|95.0|-4.0|-1.5|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16||-1.5|-4.0|<0.0001
70880609|NCT00663052|141246003|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-2.1||||0.0012|TWO_SIDED|95.0|-3.3|-0.8|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20||-0.8|-3.3|0.0012
70880610|NCT00663052|141246003|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-2.0||||0.0042|TWO_SIDED|95.0|-3.4|-0.7|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||-0.7|-3.4|0.0042
70880611|NCT00663052|141246004|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|||Comparison of treatment groups for PASI 50. Log rank test used to compare groups; CI based on product-limit method.||||<0.0001
70880612|NCT00663052|141246004|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|||Comparison of treatment groups for PASI 75. Log rank test used to compare groups; CI based on product-limit method.||||<0.0001
70880613|NCT00663052|141246004|SUPERIORITY_OR_OTHER|||||||0.0053|TWO_SIDED||||||Log Rank|||Comparison of treatment groups for PASI 90. Log rank test used to compare groups; CI based on product-limit method.||||0.0053
70880614|NCT00663052|141246004|SUPERIORITY_OR_OTHER|||||||0.0432|TWO_SIDED||||||Log Rank|||Comparison of treatment groups for PASI 100. Log rank test used to compare groups; CI based on product-limit method.||||0.0432
70960445|NCT01122862|141425179|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|0.74|||<|0.0001|TWO_SIDED|95.0|0.57|0.92||No adjustment for multiple comparisons was made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||0.92|0.57|<0.0001
70960446|NCT01122862|141425180|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.2||||0.11|TWO_SIDED|95.0|-0.44|0.05||No adjustment for multiple comparisons was made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||0.05|-0.44|0.1100
70960447|NCT01122862|141425180|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.68|||<|0.0001|TWO_SIDED|95.0|1.44|1.93||No adjustment for multiple comparisons was made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||1.93|1.44|<0.0001
70960448|NCT01122862|141425181|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.03||||0.728||95.0|-0.16|0.23||No adjustment for multiple comparisons was made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||0.23|-0.16|0.7280
70960449|NCT01122862|141425181|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.88|||<|0.0001|TWO_SIDED|95.0|0.68|1.08||No adjustment for multiple comparisons was made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||1.08|0.68|<0.0001
70960450|NCT03421431|141425221|SUPERIORITY||Least Squares (LS) mean difference|12.46||||0.0495|TWO_SIDED|95.0|0.029|24.891|||ANCOVA|||||24.891|0.029|0.0495
70960451|NCT03421431|141425221|SUPERIORITY||LS mean difference|6.257||||0.3039|TWO_SIDED|95.0|-5.754|18.268|||ANCOVA|||||18.268|-5.754|0.3039
70960452|NCT03421431|141425221|SUPERIORITY||LS mean difference|6.203||||0.213|TWO_SIDED|95.0|-3.615|16.021|||ANCOVA|||||16.021|-3.615|0.2130
70960453|NCT03421431|141425222|SUPERIORITY||LS mean difference|4.717||||0.0009|TWO_SIDED|95.0|1.98|7.455|||ANCOVA|||||7.455|1.980|0.0009
70960454|NCT03421431|141425222|SUPERIORITY||LS mean difference|0.934||||0.4946|TWO_SIDED|95.0|-1.766|3.635|||ANCOVA|||||3.635|-1.766|0.4946
70960455|NCT03421431|141425222|SUPERIORITY||LS mean difference|3.783||||0.0005|TWO_SIDED|95.0|1.708|5.858|||ANCOVA|||||5.858|1.708|0.0005
70960456|NCT03421431|141425223|SUPERIORITY||LS mean difference|0.076||||0.2756|TWO_SIDED|95.0|-0.062|0.214|||ANCOVA|||||0.214|-0.062|0.2756
70960457|NCT03421431|141425223|SUPERIORITY||LS mean difference|-0.003||||0.9686|TWO_SIDED|95.0|-0.136|0.131|||ANCOVA|||||0.131|-0.136|0.9686
70960458|NCT03421431|141425223|SUPERIORITY||LS mean difference|0.079||||0.1406|TWO_SIDED|95.0|-0.026|0.184|||ANCOVA|||||0.184|-0.026|0.1406
70960459|NCT03421431|141425224|SUPERIORITY||LS mean difference|-0.125||||0.613|TWO_SIDED|95.0|-0.613|0.363|||ANCOVA|||||0.363|-0.613|0.6130
70960460|NCT03421431|141425224|SUPERIORITY||LS mean difference|-0.049||||0.8366|TWO_SIDED|95.0|-0.521|0.423|||ANCOVA|||||0.423|-0.521|0.8366
70960461|NCT03421431|141425224|SUPERIORITY||LS mean difference|-0.076||||0.7015|TWO_SIDED|95.0|-0.466|0.315|||ANCOVA|||||0.315|-0.466|0.7015
70960462|NCT03421431|141425225|SUPERIORITY||LS mean difference|-0.186||||0.3875|TWO_SIDED|95.0|-0.613|0.24|||ANCOVA|||||0.240|-0.613|0.3875
70960463|NCT03421431|141425225|SUPERIORITY||LS mean difference|-0.248||||0.2331|TWO_SIDED|95.0|-0.657|0.162|||ANCOVA|||||0.162|-0.657|0.2331
70960464|NCT03421431|141425225|SUPERIORITY||LS mean difference|0.061||||0.7164|TWO_SIDED|95.0|-0.272|0.395|||ANCOVA|||||0.395|-0.272|0.7164
70960465|NCT03421431|141425226|SUPERIORITY||LS mean difference|0.21|||<|0.0001|TWO_SIDED|95.0|0.11|0.311|||ANCOVA|||||0.311|0.110|<0.0001
70960466|NCT03421431|141425226|SUPERIORITY||LS mean difference|0.046||||0.348|TWO_SIDED|95.0|-0.051|0.143|||ANCOVA|||||0.143|-0.051|0.3480
70960467|NCT03421431|141425226|SUPERIORITY||LS mean difference|0.164|||<|0.0001|TWO_SIDED|95.0|0.085|0.243|||ANCOVA|||||0.243|0.085|<0.0001
70960468|NCT03421431|141425227|SUPERIORITY||LS mean difference|-0.299||||0.0897|TWO_SIDED|95.0|-0.645|0.047|||ANCOVA|||||0.047|-0.645|0.0897
70960469|NCT03421431|141425227|SUPERIORITY||LS mean difference|-0.251||||0.1411|TWO_SIDED|95.0|-0.586|0.085|||ANCOVA|||||0.085|-0.586|0.1411
70960470|NCT03421431|141425227|SUPERIORITY||LS mean difference|-0.048||||0.733|TWO_SIDED|95.0|-0.326|0.23|||ANCOVA|||||0.230|-0.326|0.7330
70960471|NCT03421431|141425228|SUPERIORITY||LS mean difference|51.873||||0.9143|TWO_SIDED|95.0|-901.574|1005.32|||ANCOVA|||||1005.320|-901.574|0.9143
70960472|NCT03421431|141425228|SUPERIORITY||LS mean difference|404.168||||0.3718|TWO_SIDED|95.0|-489.519|1297.854|||ANCOVA|||||1297.854|-489.519|0.3718
70960473|NCT03421431|141425228|SUPERIORITY||LS mean difference|-352.295||||0.3466|TWO_SIDED|95.0|-1091.308|386.719|||ANCOVA|||||386.719|-1091.308|0.3466
70960474|NCT03421431|141425229|SUPERIORITY||LS mean difference|0.173||||0.0003|TWO_SIDED|95.0|0.081|0.264|||ANCOVA|||||0.264|0.081|0.0003
70960475|NCT03421431|141425229|SUPERIORITY||LS mean difference|0.025||||0.5685|TWO_SIDED|95.0|-0.062|0.113|||ANCOVA|||||0.113|-0.062|0.5685
70960476|NCT03421431|141425229|SUPERIORITY||LS mean difference|0.147|||<|0.0001|TWO_SIDED|95.0|0.075|0.219|||ANCOVA|||||0.219|0.075|<0.0001
70960477|NCT03421431|141425230|SUPERIORITY||LS mean difference|-0.133||||0.0282|TWO_SIDED|95.0|-0.252|-0.015|||ANCOVA|||||-0.015|-0.252|0.0282
70960478|NCT03421431|141425230|SUPERIORITY||LS mean difference|-0.068||||0.2412|TWO_SIDED|95.0|-0.182|0.046|||ANCOVA|||||0.046|-0.182|0.2412
70960479|NCT03421431|141425230|SUPERIORITY||LS mean difference|-0.066||||0.1649|TWO_SIDED|95.0|-0.158|0.027|||ANCOVA|||||0.027|-0.158|0.1649
70960480|NCT03421431|141425231|SUPERIORITY||LS mean difference|0.009||||0.4357|TWO_SIDED|95.0|-0.014|0.032|||ANCOVA|||||0.032|-0.014|0.4357
70960481|NCT03421431|141425231|SUPERIORITY||LS mean difference|0.001||||0.8989|TWO_SIDED|95.0|-0.021|0.023|||ANCOVA|||||0.023|-0.021|0.8989
70960482|NCT03421431|141425231|SUPERIORITY||LS mean difference|0.008||||0.412|TWO_SIDED|95.0|-0.011|0.026|||ANCOVA|||||0.026|-0.011|0.4120
70960483|NCT03421431|141425232|SUPERIORITY||LS mean difference|-1.731||||0.0134|TWO_SIDED|95.0|-3.095|-0.368|||ANCOVA|||||-0.368|-3.095|0.0134
70960484|NCT03421431|141425232|SUPERIORITY||LS mean difference|-0.327||||0.6263|TWO_SIDED|95.0|-1.656|1.001|||ANCOVA|||||1.001|-1.656|0.6263
70960485|NCT03421431|141425232|SUPERIORITY||LS mean difference|-1.404||||0.0115|TWO_SIDED|95.0|-2.487|-0.322|||ANCOVA|||||-0.322|-2.487|0.0115
70880615|NCT00663052|141246005|SUPERIORITY_OR_OTHER||Proportion difference|0.0|||||TWO_SIDED|95.0|-0.74|0.74|||Fisher Exact|||Comparison between treatment groups at Week 2||0.74|-0.74|
70960486|NCT03421431|141425233|SUPERIORITY||LS mean difference|-3.723||||0.4608|TWO_SIDED|95.0|-13.7|6.253|||ANCOVA|||||6.253|-13.700|0.4608
70960487|NCT03421431|141425233|SUPERIORITY||LS mean difference|-2.377||||0.6238|TWO_SIDED|95.0|-11.962|7.207|||ANCOVA|||||7.207|-11.962|0.6238
70960488|NCT03421431|141425233|SUPERIORITY||LS mean difference|-1.346||||0.7367|TWO_SIDED|95.0|-9.268|6.576|||ANCOVA|||||6.576|-9.268|0.7367
70960489|NCT03421431|141425234|SUPERIORITY||LS mean difference|-0.407||||0.8302|TWO_SIDED|95.0|-4.287|3.474|||ANCOVA|||||3.474|-4.287|0.8302
70960490|NCT03421431|141425234|SUPERIORITY||LS mean difference|-1.28||||0.5053|TWO_SIDED|95.0|-5.192|2.632|||ANCOVA|||||2.632|-5.192|0.5053
70960491|NCT03421431|141425234|SUPERIORITY||LS mean difference|0.873||||0.476|TWO_SIDED|95.0|-1.62|3.366|||ANCOVA|||||3.366|-1.620|0.4760
70960492|NCT03421431|141425235|SUPERIORITY||LS mean difference|-5.91||||0.0639|TWO_SIDED|95.0|-12.171|0.351|||ANCOVA|||||0.351|-12.171|0.0639
70960493|NCT03421431|141425235|SUPERIORITY||LS mean difference|-2.064||||0.4884|TWO_SIDED|95.0|-7.971|3.843|||ANCOVA|||||3.843|-7.971|0.4884
70960494|NCT03421431|141425235|SUPERIORITY||LS mean difference|-3.846||||0.1532|TWO_SIDED|95.0|-9.156|1.464|||ANCOVA|||||1.464|-9.156|0.1532
70960495|NCT03421431|141425236|SUPERIORITY||LS mean difference|-0.46||||0.0811|TWO_SIDED|95.0|-0.978|0.058|||ANCOVA|||||0.058|-0.978|0.0811
70960496|NCT03421431|141425236|SUPERIORITY||LS mean difference|0.117||||0.6312|TWO_SIDED|95.0|-0.367|0.601|||ANCOVA|||||0.601|-0.367|0.6312
70960497|NCT03421431|141425236|SUPERIORITY||LS mean difference|-0.577||||0.0099|TWO_SIDED|95.0|-1.011|-0.143|||ANCOVA|||||-0.143|-1.011|0.0099
70960498|NCT03421431|141425249|SUPERIORITY||LS mean difference|1.356||||0.112|TWO_SIDED|95.0|-0.322|3.034|||ANCOVA|||||3.034|-0.322|0.1120
70960499|NCT03421431|141425249|SUPERIORITY||LS mean difference|0.647||||0.4229|TWO_SIDED|95.0|-0.947|2.24|||ANCOVA|||||2.240|-0.947|0.4229
70960500|NCT03421431|141425249|SUPERIORITY||LS mean difference|0.71||||0.2764|TWO_SIDED|95.0|-0.577|1.996|||ANCOVA|||||1.996|-0.577|0.2764
70960501|NCT03421431|141425250|SUPERIORITY||LS mean difference|0.008||||0.5606|TWO_SIDED|95.0|-0.02|0.037|||ANCOVA|||||0.037|-0.020|0.5606
70960502|NCT03421431|141425250|SUPERIORITY||LS mean difference|0.023||||0.1002|TWO_SIDED|95.0|-0.004|0.05|||ANCOVA|||||0.050|-0.004|0.1002
70960503|NCT03421431|141425250|SUPERIORITY||LS mean difference|-0.014||||0.2002|TWO_SIDED|95.0|-0.036|0.008|||ANCOVA|||||0.008|-0.036|0.2002
70960504|NCT03421431|141425251|SUPERIORITY||LS mean difference|-178.787||||0.7014|TWO_SIDED|95.0|-1098.454|740.88|||ANCOVA|||||740.880|-1098.454|0.7014
70960505|NCT03421431|141425251|SUPERIORITY||LS mean difference|52.307||||0.907|TWO_SIDED|95.0|-830.934|935.547|||ANCOVA|||||935.547|-830.934|0.9070
70960506|NCT03421431|141425251|SUPERIORITY||LS mean difference|-231.094||||0.536|TWO_SIDED|95.0|-967.273|505.086|||ANCOVA|||||505.086|-967.273|0.5360
70960507|NCT03421431|141425252|SUPERIORITY||LS mean difference|-753.153||||0.2985|TWO_SIDED|95.0|-2183.92|677.614|||ANCOVA|||||677.614|-2183.920|0.2985
70960508|NCT03421431|141425252|SUPERIORITY||LS mean difference|139.107||||0.8413|TWO_SIDED|95.0|-1236.689|1514.902|||ANCOVA|||||1514.902|-1236.689|0.8413
70960509|NCT03421431|141425252|SUPERIORITY||LS mean difference|-892.26||||0.1168|TWO_SIDED|95.0|-2011.705|227.186|||ANCOVA|||||227.186|-2011.705|0.1168
70960510|NCT03421431|141425253|SUPERIORITY||LS mean difference|33.491|||<|0.0001|TWO_SIDED|95.0|17.984|48.998|||ANCOVA|||||48.998|17.984|<0.0001
70960511|NCT03421431|141425253|SUPERIORITY||LS mean difference|30.814|||<|0.0001|TWO_SIDED|95.0|15.802|45.825|||ANCOVA|||||45.825|15.802|<0.0001
70960512|NCT03421431|141425253|SUPERIORITY||LS mean difference|2.677||||0.6757|TWO_SIDED|95.0|-9.946|15.3|||ANCOVA|||||15.300|-9.946|0.6757
70960513|NCT03421431|141425254|SUPERIORITY||LS mean difference|21.3||||0.0134|TWO_SIDED|95.0|4.533|38.067|||ANCOVA|||||38.067|4.533|0.0134
70960514|NCT03421431|141425254|SUPERIORITY||LS mean difference|5.847||||0.4686|TWO_SIDED|95.0|-10.116|21.811|||ANCOVA|||||21.811|-10.116|0.4686
70880616|NCT00663052|141246005|SUPERIORITY_OR_OTHER||Proportion difference|-0.73||||1|TWO_SIDED|95.0|-2.9|1.44|||Fisher Exact|||Comparison between treatment groups at Week 4||1.44|-2.90|1.0000
70880617|NCT00663052|141246005|SUPERIORITY_OR_OTHER||Proportion difference|0.04||||1|TWO_SIDED|95.0|-3.58|3.67|||Fisher Exact|||Comparison between treatment groups at Week 8||3.67|-3.58|1.0000
70880618|NCT00663052|141246005|SUPERIORITY_OR_OTHER||Proportion difference|6.1||||0.0401|TWO_SIDED|95.0|-0.26|12.47|||Fisher Exact|||Comparison between treatment groups at Week 12||12.47|-0.26|0.0401
70880619|NCT00663052|141246005|SUPERIORITY_OR_OTHER||Proportion difference|3.29||||0.4415|TWO_SIDED|95.0|-4.95|11.54|||Fisher Exact|||Comparison between treatment groups at Week 16||11.54|-4.95|0.4415
70880620|NCT00663052|141246005|SUPERIORITY_OR_OTHER||Proportion difference|8.6||||0.0617|TWO_SIDED|95.0|-0.67|17.87|||Fisher Exact|||Comparison between treatment groups at Week 20||17.87|-0.67|0.0617
70880621|NCT00663052|141246005|SUPERIORITY_OR_OTHER||Proportion difference|8.64||||0.072|TWO_SIDED|95.0|-0.96|18.24|||Fisher Exact|||Comparison between treatment groups at Week 24||18.24|-0.96|0.0720
70880622|NCT00663052|141246006|SUPERIORITY_OR_OTHER||Proportion difference|-1.45||||0.6223|TWO_SIDED|95.0|-5.07|2.16|||Fisher Exact|||Comparison between treatment groups at Week 2||2.16|-5.07|0.6223
70880623|NCT00663052|141246006|SUPERIORITY_OR_OTHER||Proportion difference|6.21||||0.1|TWO_SIDED|95.0|-1.56|13.98|||Fisher Exact|||Comparison between treatment groups at Week 4||13.98|-1.56|0.1000
70880624|NCT00663052|141246006|SUPERIORITY_OR_OTHER||Proportion difference|15.59||||0.0037|TWO_SIDED|95.0|4.53|26.65|||Fisher Exact|||Comparison between treatment groups at Week 8||26.65|4.53|0.0037
70880625|NCT00663052|141246006|SUPERIORITY_OR_OTHER||Proportion difference|22.04||||0.0004|TWO_SIDED|95.0|9.75|34.33|||Fisher Exact|||Comparison between treatment groups at Week 12||34.33|9.75|0.0004
70960515|NCT03421431|141425254|SUPERIORITY||LS mean difference|15.453||||0.0181|TWO_SIDED|95.0|2.699|28.206|||ANCOVA|||||28.206|2.699|0.0181
70960516|NCT03421431|141425255|SUPERIORITY||LS mean difference|4.324||||0.0557|TWO_SIDED|95.0|-0.108|8.756|||ANCOVA|||||8.756|-0.108|0.0557
70960517|NCT03421431|141425255|SUPERIORITY||LS mean difference|2.305||||0.2867|TWO_SIDED|95.0|-1.955|6.566|||ANCOVA|||||6.566|-1.955|0.2867
70960518|NCT03421431|141425255|SUPERIORITY||LS mean difference|2.019||||0.2437|TWO_SIDED|95.0|-1.39|5.429|||ANCOVA|||||5.429|-1.390|0.2437
70960519|NCT03421431|141425256|SUPERIORITY||LS mean difference|0.019||||0.9913|TWO_SIDED|95.0|-3.491|3.53|||ANCOVA|||||3.530|-3.491|0.9913
70960520|NCT03421431|141425256|SUPERIORITY||LS mean difference|0.995||||0.553|TWO_SIDED|95.0|-2.323|4.314|||ANCOVA|||||4.314|-2.323|0.5530
70960521|NCT03421431|141425256|SUPERIORITY||LS mean difference|-0.976||||0.4729|TWO_SIDED|95.0|-3.665|1.713|||ANCOVA|||||1.713|-3.665|0.4729
70960522|NCT04147650|141425262|SUPERIORITY||Odds Ratio (OR)|2.18||||0.1352|TWO_SIDED|95.0|0.62|7.62|||Regression, Logistic|||0.05 % VOS versus vehicle||7.62|0.62|0.1352
70960523|NCT04147650|141425262|SUPERIORITY||Odds Ratio (OR)|1.78||||0.2823|TWO_SIDED|95.0|0.49|6.45|||Regression, Logistic|||0.10% VOS versus vehicle||6.45|0.49|0.2823
70960524|NCT04147650|141425262|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0889|TWO_SIDED|95.0|0.7|8.3|||Regression, Logistic|||0.20% VOS versus vehicle||8.30|0.70|0.0889
70960525|NCT04147650|141425263|SUPERIORITY||Least square mean difference|-2.6||||0.3604|TWO_SIDED|95.0|-9.6|4.3|||ANCOVA|||0.05% VOS versus vehicle||4.3|-9.6|0.3604
70960526|NCT04147650|141425263|SUPERIORITY||Least square mean difference|-2.6||||0.3737|TWO_SIDED|95.0|-9.6|4.4|||ANCOVA|||0.10% VOS versus vehicle||4.4|-9.6|0.3737
70960527|NCT04147650|141425263|SUPERIORITY||Least square mean difference|1.8||||0.5307|TWO_SIDED|95.0|-5.1|8.6|||ANCOVA|||0.20% VOS versus vehicle||8.6|-5.1|0.5307
70960528|NCT01128738|141425282|SUPERIORITY_OR_OTHER||Percentage difference|50.2|||<|0.001|TWO_SIDED|95.0|38.1|62.3|||Fisher Exact||Percentage difference was estimated as BTX 50 U minus placebo.|||62.3|38.1|<0.001
70960529|NCT01178671|141425330|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||Mixed Models Analysis|||||||0.17
70880626|NCT00663052|141246006|SUPERIORITY_OR_OTHER||Proportion difference|13.46||||0.0285|TWO_SIDED|95.0|0.94|25.97|||Fisher Exact|||Comparison between treatment groups at Week 16||25.97|0.94|0.0285
70960530|NCT01178671|141425331|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||t-test, 2 sided|||||||0.82
70960531|NCT01178671|141425332|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||t-test, 2 sided|||||||.14
70960532|NCT01178671|141425333|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||.50
70960533|NCT01178671|141425334|SUPERIORITY_OR_OTHER|||||||0.023|TWO_SIDED||||||Mixed Models Analysis|||||||0.023
70960534|NCT01178671|141425335|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.31|TWO_SIDED||||||Mixed Models Analysis|||||||0.31
70960535|NCT01178671|141425336|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.7||||0.042|TWO_SIDED|95.0|1.1|19.9|||Mixed Models Analysis|||||19.9|1.1|0.042
70960536|NCT01178671|141425337|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||Chi-squared|||||||0.14
70960537|NCT01178671|141425338|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||Mixed Models Analysis|||||||0.21
70960538|NCT01178671|141425339|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||Mixed Models Analysis|||||||0.65
70960539|NCT02349451|141425345|SUPERIORITY||response rate difference|39.8|||<|0.001|TWO_SIDED|95.0|17.2|57.7||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group. The a priori statistical significance threshold is P = 0.025.|Fisher Exact|||||57.7|17.2|<0.001
70960540|NCT02349451|141425345|SUPERIORITY||response rate difference|50.3|||<|0.001|TWO_SIDED|95.0|28.1|67.4||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group. The a priori statistical significance threshold is P = 0.025.|Fisher Exact|||||67.4|28.1|<0.001
70960541|NCT02349451|141425346|SUPERIORITY||response rate difference|-3.3||||0.723|TWO_SIDED|95.0|-18.5|12.1||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact|||||12.1|-18.5|0.723
70960542|NCT02349451|141425346|SUPERIORITY||response rate difference|7.3||||0.215|TWO_SIDED|95.0|-7.4|21.6||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact|||||21.6|-7.4|0.215
70960543|NCT02349451|141425347|SUPERIORITY||response rate difference|24.1||||0.021|TWO_SIDED|95.0|3.9|39.3||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.|Fisher Exact|||||39.3|3.9|0.021
70960544|NCT02349451|141425347|SUPERIORITY||response rate difference|-0.9||||0.611|TWO_SIDED|95.0|-16.5|14.8||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact|||||14.8|-16.5|0.611
70960545|NCT02349451|141425347|SUPERIORITY||response rate difference|40.9|||<|0.001|TWO_SIDED|95.0|20.1|55.8||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.|Fisher Exact|||||55.8|20.1|<0.001
70960546|NCT02349451|141425347|SUPERIORITY||response rate difference|15.9||||0.039|TWO_SIDED|95.0|-0.3|31.3||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact|||||31.3|-0.3|0.039
70960547|NCT02349451|141425348|SUPERIORITY||response rate difference|18.4||||0.034|TWO_SIDED|95.0|1.5|29.7||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.|Fisher Exact|||||29.7|1.5|0.034
70960548|NCT02349451|141425348|SUPERIORITY||response rate difference|7.3||||0.185|TWO_SIDED|95.0|-5.8|19.9||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact|||||19.9|-5.8|0.185
70960549|NCT02349451|141425348|SUPERIORITY||response rate difference|27.3||||0.004|TWO_SIDED|95.0|9.6|39.0||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.|Fisher Exact|||||39.0|9.6|0.004
70960550|NCT02349451|141425348|SUPERIORITY||response rate difference|16.2||||0.017|TWO_SIDED|95.0|2.3|29.3||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact|||||29.3|2.3|0.017
70960551|NCT02349451|141425349|SUPERIORITY||||||<|0.001||||||Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with placebo group.|Kolmogorov-Smirnov test|||||||<0.001
70960552|NCT02349451|141425349|SUPERIORITY|||||||0.561||||||Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with adalimumab group.|Kolmogorov-Smirnov test|||||||0.561
70960553|NCT02349451|141425349|SUPERIORITY||||||<|0.001||||||Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with placebo group.|Kolmogorov-Smirnov test|||||||<0.001
70960554|NCT02349451|141425349|SUPERIORITY|||||||0.106||||||Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with adalimumab group.|Kolmogorov-Smirnov test|||||||0.106
70960555|NCT02349451|141425350|SUPERIORITY||Least squares mean difference|-1.07|||<|0.001|TWO_SIDED|95.0|-1.58|-0.57||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-0.57|-1.58|<0.001
70960556|NCT02349451|141425350|SUPERIORITY||Least squares mean difference|-0.13||||0.479|TWO_SIDED|95.0|-0.48|0.23||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||0.23|-0.48|0.479
70960557|NCT02349451|141425350|SUPERIORITY||Least squares mean difference|-1.4|||<|0.001|TWO_SIDED|95.0|-1.9|-0.89||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-0.89|-1.90|<0.001
70960558|NCT02349451|141425350|SUPERIORITY||Least squares mean difference|-0.45||||0.012|TWO_SIDED|95.0|-0.81|-0.1||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-0.10|-0.81|0.012
70960559|NCT02349451|141425351|SUPERIORITY||Least squares mean difference|-1.17|||<|0.001|TWO_SIDED|95.0|-1.81|-0.53||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-0.53|-1.81|<0.001
70960560|NCT02349451|141425351|SUPERIORITY||Least squares mean difference|-0.09||||0.696|TWO_SIDED|95.0|-0.54|0.36||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||0.36|-0.54|0.696
70960561|NCT02349451|141425351|SUPERIORITY||Least squares mean difference|-1.41|||<|0.001|TWO_SIDED|95.0|-2.04|-0.77||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-0.77|-2.04|<0.001
70960562|NCT02349451|141425351|SUPERIORITY||Least squares mean difference|-0.33||||0.151|TWO_SIDED|95.0|-0.77|0.12||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||0.12|-0.77|0.151
70960563|NCT02349451|141425352|SUPERIORITY||Least squares mean difference|-3.17|||<|0.001|TWO_SIDED|95.0|-4.14|-2.19||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-2.19|-4.14|<0.001
70880627|NCT00663052|141246006|SUPERIORITY_OR_OTHER||Proportion difference|15.05||||0.0139|TWO_SIDED|95.0|2.67|27.43|||Fisher Exact|||Comparison between treatment groups at Week 20||27.43|2.67|0.0139
70880628|NCT00663052|141246006|SUPERIORITY_OR_OTHER||Proportion difference|19.56||||0.0012|TWO_SIDED|95.0|7.38|31.74|||Fisher Exact|||Comparison between treatment groups at Week 24||31.74|7.38|0.0012
70880629|NCT00663052|141246007|SUPERIORITY_OR_OTHER||Proportion difference|5.01||||0.3956|TWO_SIDED|95.0|-6.01|16.03|||Fisher Exact|||Comparison between treatment groups at Week 2||16.03|-6.01|0.3956
70880630|NCT00663052|141246007|SUPERIORITY_OR_OTHER||Proportion difference|8.66||||0.1754|TWO_SIDED|95.0|-3.82|21.14|||Fisher Exact|||Comparison between treatment groups at Week 4||21.14|-3.82|0.1754
70880631|NCT00663052|141246007|SUPERIORITY_OR_OTHER||Proportion difference|13.81||||0.0207|TWO_SIDED|95.0|1.9|25.72|||Fisher Exact|||Comparison between treatment groups at Week 8||25.72|1.90|0.0207
70880632|NCT00663052|141246007|SUPERIORITY_OR_OTHER||Proportion difference|19.38|||<|0.0001|TWO_SIDED|95.0|9.23|29.53|||Fisher Exact|||Comparison between treatment groups at Week 12||29.53|9.23|<0.0001
70880633|NCT00663052|141246007|SUPERIORITY_OR_OTHER||Proportion difference|13.54||||0.0044|TWO_SIDED|95.0|3.79|23.29|||Fisher Exact|||Comparison between treatment groups at Week 16||23.29|3.79|0.0044
70880634|NCT00663052|141246007|SUPERIORITY_OR_OTHER||Proportion difference|10.62||||0.0223|TWO_SIDED|95.0|1.11|20.13|||Fisher Exact|||Comparison between treatment groups at Week 20||20.13|1.11|0.0223
70880635|NCT00663052|141246007|SUPERIORITY_OR_OTHER||Proportion difference|11.37||||0.0133|TWO_SIDED|95.0|1.96|20.78|||Fisher Exact|||Comparison between treatment groups at Week 24||20.78|1.96|0.0133
70880636|NCT00663052|141246008|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Log Rank|||Comparison between treatment groups for PGA Clear/Almost Clear (0,1). Log rank test used to compare groups; CI based on product-limit method.||||0.0003
70880637|NCT00663052|141246008|SUPERIORITY_OR_OTHER|||||||0.0022|TWO_SIDED||||||Log Rank|||Comparison between treatment groups for PGA Clear/Almost Clear/Mild (0,1,2). Log rank test used to compare groups; CI based on product-limit method.||||0.0022
70880638|NCT00663052|141246009|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||0.0193|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2||-0.0|-0.3|0.0193
70880639|NCT00663052|141246009|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||0.0114|TWO_SIDED|95.0|-0.4|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4||-0.1|-0.4|0.0114
70880640|NCT00663052|141246009|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.3||||0.0006|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8||-0.2|-0.5|0.0006
70880641|NCT00663052|141246009|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||-0.3|-0.7|<0.0001
70880642|NCT00663052|141246009|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.3||||0.0058|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16||-0.1|-0.5|0.0058
70880643|NCT00663052|141246009|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.4||||0.0018|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20||-0.1|-0.6|0.0018
70880644|NCT00663052|141246009|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.4||||0.0009|TWO_SIDED|95.0|-0.6|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||-0.2|-0.6|0.0009
70880645|NCT00663052|141246010|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.1||||0.6396|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2||0.2|-0.3|0.6396
70880646|NCT00663052|141246010|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.4||||0.0074|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4||-0.1|-0.7|0.0074
70880647|NCT00663052|141246010|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.6||||0.0007|TWO_SIDED|95.0|-0.9|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8||-0.2|-0.9|0.0007
70880648|NCT00663052|141246010|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.5|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||-0.5|-1.1|<0.0001
70880649|NCT00663052|141246010|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.5||||0.004|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16||-0.1|-0.8|0.0040
70880650|NCT00663052|141246010|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.6||||0.0004|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20||-0.3|-0.9|0.0004
70880651|NCT00663052|141246010|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||0.1799|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||-0.1|-0.5|0.1799
70960564|NCT02349451|141425352|SUPERIORITY||Least squares mean difference|-0.81||||0.021|TWO_SIDED|95.0|-1.51|-0.12||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-0.12|-1.51|0.021
70960565|NCT02349451|141425352|SUPERIORITY||Least squares mean difference|-2.73|||<|0.001|TWO_SIDED|95.0|-3.7|-1.75||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-1.75|-3.70|<0.001
70960566|NCT02349451|141425352|SUPERIORITY||Least squares mean difference|-0.37||||0.288|TWO_SIDED|95.0|-1.06|0.32||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||0.32|-1.06|0.288
70960567|NCT02683941|141425354|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.866|TWO_SIDED|95.0|0.48|1.95|||Log Rank|||The hazard ratio and the 95% confidence interval (CI) were estimated using a Cox proportional hazards model, stratified for interactive web response system (IWRS) tumour subtype (typical versus \[vs\] atypical) using the exact method for ties. P-value of stratified log rank test comparing lanreotide to placebo with strata based on the IWRS tumour subtype (typical vs atypical) stratification factor.||1.95|0.48|0.866
70960568|NCT02683941|141425355|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.837|TWO_SIDED|95.0|0.48|1.88|||Log Rank|||The hazard ratio and the 95% CI were estimated using a Cox proportional hazards model, stratified for IWRS tumour subtype (typical vs atypical) using the exact method for ties. P-value of stratified log rank test comparing lanreotide to placebo with strata based on the IWRS tumour subtype (typical vs atypical) stratification factor.||1.88|0.48|0.837
70960569|NCT02683941|141425356|OTHER||Percentage difference|14.0|||||TWO_SIDED|95.0|-10.97|37.86||||||The treatment difference compares lanreotide to placebo (central review). The 95% exact unconditional CI was used for ORR difference.||37.86|-10.97|
70960570|NCT02683941|141425356|OTHER||Percentage difference|2.0|||||TWO_SIDED|95.0|-22.69|26.53||||||The treatment difference compares lanreotide to placebo (local review). The 95% exact unconditional CI was used for ORR difference.||26.53|-22.69|
70960571|NCT02683941|141425357|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.582|TWO_SIDED|95.0|0.5|1.5|||Log Rank|||The hazard ratio and the 95% CI were estimated using a Cox proportional hazards model, stratified for IWRS tumour subtype (typical vs atypical) using the exact method for ties. P-value of stratified log rank test comparing lanreotide to placebo with strata based on the IWRS tumour subtype (typical vs atypical) stratification factor.||1.50|0.50|0.582
70960572|NCT01519466|141425400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_DEVIATION|2.32||0.0926|TWO_SIDED|95.0|-1.55|0.12|||t-test, 2 sided|||||0.12|-1.55|0.0926
70960573|NCT01519466|141425400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17|STANDARD_DEVIATION|2.97||||||||||||||||
70960574|NCT01519466|141425401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|0.49||0.3251|TWO_SIDED|95.0|-0.27|0.09|||t-test, 2 sided|||||0.09|-0.27|0.3251
70960575|NCT01519466|141425401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|0.51||||||||||||||||
70960576|NCT01519466|141425402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_DEVIATION|1.26||0.5798|TWO_SIDED|95.0|-0.33|0.58|||t-test, 2 sided|||Hyperglycaemia, glucose above 10mmol/l (180mg/dL)||0.58|-0.33|0.5798
70960577|NCT01519466|141425402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|STANDARD_DEVIATION|1.03||0.096|TWO_SIDED|95.0|-0.68|0.06|||t-test, 2 sided|||Hypoglycaemia, glucose below 3.9mmol/l (70mg/dL)||0.06|-0.68|0.0960
70960578|NCT01519466|141425402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.36|STANDARD_DEVIATION|6.53||0.0007|TWO_SIDED|95.0|2.01|6.71|||t-test, 2 sided|||Treatment Satisfaction||6.71|2.01|0.0007
70960579|NCT00147823|141425404|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|Using baseline (6 wk) and two year post operative predicted effects data, and setting desirable power to detect our effects to 80%||The sample size provided at least 80% power at a 5% alpha level to detect a medium to large effect in patients receiving Vitoss alone compared to combination therapy consisting of Vitoss with Bone Marrow Aspirate. Since a random coefficients model was used to analyze the data, the sample size calculation was estimated under this model assuming a 3% attrition rate between all measurement times.||||<0.01
70960580|NCT00147823|141425405|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared, Corrected|||||||<0.01
70960581|NCT00561951|141425432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.002||95.0|-0.56|-0.13||The closed testing procedure was used in order to control the probability of a type 1 error.|ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.13|-0.56|0.002
70960582|NCT00561951|141425432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||<|0.001||95.0|-0.6|-0.17||The closed testing procedure was used in order to control the probability of a type 1 error.|ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.17|-0.60|<0.001
70960583|NCT00561951|141425434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.002||95.0|-0.91|-0.22|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.22|-0.91|0.002
70960584|NCT00561951|141425434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|||<|0.001||95.0|-1.01|-0.32|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.32|-1.01|<0.001
70960585|NCT00561951|141425436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.003||95.0|-1.07|-0.22|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.22|-1.07|0.003
70960586|NCT00561951|141425436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.002||95.0|-1.09|-0.23|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.23|-1.09|0.002
70960587|NCT00561951|141425438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.002||95.0|-0.63|-0.14|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.14|-0.63|0.002
70880652|NCT00663052|141246011|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|0.0||||0.7757|TWO_SIDED|95.0|-0.2|0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2||0.3|-0.2|0.7757
70880653|NCT00663052|141246011|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||0.2112|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4||0.1|-0.4|0.2112
70880654|NCT00663052|141246011|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.1||||0.5467|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8||0.2|-0.3|0.5467
70880655|NCT00663052|141246011|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.1||||0.3684|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||0.1|-0.4|0.3684
70880656|NCT00663052|141246011|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||-0.2046|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16||0.1|-0.4|-0.2046
70880657|NCT00663052|141246011|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||0.0649|TWO_SIDED|95.0|-0.5|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20||0.0|-0.5|0.0649
70880658|NCT00663052|141246011|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|0.0||||0.8683|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||0.2|-0.3|0.8683
70880659|NCT00663052|141246012|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|0.0||||0.8898|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2||0.2|-0.3|0.8898
70880660|NCT00663052|141246012|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.4||||0.009|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4||-0.1|-0.7|0.0090
70880661|NCT00663052|141246012|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.4||||0.0028|TWO_SIDED|95.0|-0.7|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8||-0.2|-0.7|0.0028
70880662|NCT00663052|141246012|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.6||||0.0001|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||-0.3|-0.9|0.0001
70880663|NCT00663052|141246012|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16||-0.3|-0.9|<0.0001
70880664|NCT00663052|141246012|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.5||||0.0016|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20||-0.2|-0.8|0.0016
70880665|NCT00663052|141246012|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.3||||0.0602|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||0.0|-0.6|0.0602
70880666|NCT00663052|141246015|SUPERIORITY_OR_OTHER||Proportion difference|0.42||||1|TWO_SIDED|95.0|-7.7|8.55|||Fisher Exact|||Comparison between treatment groups at Week 12||8.55|-7.70|1.0000
70880667|NCT00663052|141246015|SUPERIORITY_OR_OTHER||Proportion difference|3.94||||0.4213|TWO_SIDED|95.0|-5.75|13.63|||Fisher Exact|||Comparison between treatment groups at Week 16||13.63|-5.75|0.4213
70880668|NCT00663052|141246015|SUPERIORITY_OR_OTHER||Proportion difference|3.98||||0.4039|TWO_SIDED|95.0|-5.38|13.35|||Fisher Exact|||Comparison between treatment groups at Week 20||13.35|-5.38|0.4039
70880669|NCT00663052|141246015|SUPERIORITY_OR_OTHER||Proportion difference|2.5||||0.6168|TWO_SIDED|95.0|-6.87|11.88|||Fisher Exact|||Comparison between treatment groups at Week 24||11.88|-6.87|0.6168
70880670|NCT00663052|141246016|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||0.862|TWO_SIDED|95.0|-2.8|2.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||||2.3|-2.8|0.8620
70880671|NCT00663052|141246017|SUPERIORITY_OR_OTHER||Proportion difference|5.68||||0.3525|TWO_SIDED|95.0|-6.05|17.4|||Fisher Exact|||Comparison between treatment groups at Week 2||17.40|-6.05|0.3525
70880672|NCT00663052|141246017|SUPERIORITY_OR_OTHER||Proportion difference|14.7||||0.0202|TWO_SIDED|95.0|2.19|27.2|||Fisher Exact|||Comparison between treatment groups at Week 4||27.20|2.19|0.0202
70880673|NCT00663052|141246017|SUPERIORITY_OR_OTHER||Proportion difference|14.41||||0.0178|TWO_SIDED|95.0|2.17|26.64|||Fisher Exact|||Comparison between treatment groups at Week 8||26.64|2.17|0.0178
70960588|NCT00561951|141425438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.03||95.0|-0.52|-0.03|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.03|-0.52|0.030
70960589|NCT00561951|141425440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.624||95.0|-0.18|0.11|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||0.11|-0.18|0.624
70960590|NCT00561951|141425440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.129||95.0|-0.26|0.03|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||0.03|-0.26|0.129
70960591|NCT04508023|141425477|SUPERIORITY||Cox Proportional Hazard|1.16||||0.626|TWO_SIDED|95.0|0.63|2.15|||Log Rank|Log rank test stratified by the time from COVID-19 positive test to randomization.||||2.15|0.63|0.626
70960592|NCT01323634|141425524|SUPERIORITY_OR_OTHER||Least square mean difference|0.08|||<|0.001|TWO_SIDED|95.0|0.037|0.124|||ANCOVA|||||0.124|0.037|<0.001
70960593|NCT03622619|141425577|OTHER|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
70960594|NCT03622619|141425578|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
70960595|NCT03622619|141425579|SUPERIORITY|||||||0.055|||||||Wilcoxon (Mann-Whitney)|||||||0.055
70960596|NCT03622619|141425580|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|Burning/stinging||||||0.90
70960597|NCT03622619|141425580|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|Grittiness/foreign body sensation||||||0.30
70960598|NCT03622619|141425580|SUPERIORITY|||||||0.66||||||Dryness|Wilcoxon (Mann-Whitney)|||||||0.66
70880674|NCT00663052|141246017|SUPERIORITY_OR_OTHER||Proportion difference|21.52|||<|0.0001|TWO_SIDED|95.0|11.02|32.03|||Fisher Exact|||Comparison between treatment groups at Week 12||32.03|11.02|<0.0001
70960599|NCT03622619|141425580|SUPERIORITY|||||||0.14||||||Blurred vision|Wilcoxon (Mann-Whitney)|||||||0.14
70960600|NCT03622619|141425580|SUPERIORITY|||||||0.3||||||Overall discomfort|Wilcoxon (Mann-Whitney)|||||||0.30
70960601|NCT04223856|141425581|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|1e-05|TWO_SIDED|95.0|0.377|0.538||P value was calculated using stratified log-rank test. The p-value threshold for statistical significance is 0.005.|Log Rank||HR was calculated using stratified Cox proportional hazards model.|||0.538|0.377|<0.00001
70960602|NCT04223856|141425582|SUPERIORITY|P value was calculated using stratified log-rank test. The p-value threshold for statistical significance is 0.01548.|Hazard Ratio (HR)|0.468|||<|1e-05|TWO_SIDED|95.0|0.376|0.582|||Log Rank||HR was calculated using stratified Cox proportional hazards model.|||0.582|0.376|<0.00001
70960603|NCT03226275|141425602|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|99.46|||||TWO_SIDED|90.0|93.25|106.09||||||Statistical Comparison of Bisoprolol in Fasting state||106.09|93.25|
70960604|NCT03226275|141425602|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|96.76|||||TWO_SIDED|90.0|92.95|100.73||||||Statistical Comparison of Amlodipine in Fasting State||100.73|92.95|
70960605|NCT03226275|141425602|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|98.95|||||TWO_SIDED|90.0|90.02|108.76||||||Statistical Comparison of Bisoprolol in Fed State||108.76|90.02|
70960606|NCT03226275|141425602|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|103.07|||||TWO_SIDED|90.0|95.53|111.2||||||Statistical Comparison of Amlodipine in Fed State||111.20|95.53|
70960607|NCT03226275|141425603|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|97.85|||||TWO_SIDED|90.0|92.29|103.74||||||Statistical Comparison of Bisoprolol in Fasting State||103.74|92.29|
70960608|NCT03226275|141425603|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|100.03|||||TWO_SIDED|90.0|94.37|106.03||||||Statistical Comparison of Amlodipine in Fasting State||106.03|94.37|
70960609|NCT03226275|141425603|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|93.87|||||TWO_SIDED|90.0|84.56|104.2||||||Statistical Comparison of Bisoprolol in Fed State||104.20|84.56|
70960610|NCT03226275|141425603|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|106.56|||||TWO_SIDED|90.0|97.82|116.08||||||Statistical Comparison of Amlodipine in Fed State||116.08|97.82|
70960611|NCT03226275|141425604|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Median Difference|0.13|||||TWO_SIDED|90.0|0.0|0.5||||||Statistical Comparison of Bisoprolol in Fasting State||0.50|0.00|
70960612|NCT03226275|141425604|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Median Difference|0.0|||||TWO_SIDED|90.0|-1.0|0.0||||||Statistical Comparison of Amlodipine in Fasting State||0.00|-1.00|
70960613|NCT03226275|141425604|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Median Difference|0.0|||||TWO_SIDED|90.0|-1.0|0.5||||||Statistical Comparison of Bisoprolol in Fed State||0.50|-1.00|
70960614|NCT03226275|141425604|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Median Difference|0.0|||||TWO_SIDED|90.0|-1.0|0.5||||||Statistical Comparison of Amlodipine in Fed State||0.50|-1.00|
70960615|NCT03226275|141425606|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|99.98|||||TWO_SIDED|90.0|93.61|106.79||||||Statistical Comparison of Bisoprolol in Fasting State||106.79|93.61|
70880675|NCT00663052|141246017|SUPERIORITY_OR_OTHER||Proportion difference|10.53||||0.0325|TWO_SIDED|95.0|0.43|20.64|||Fisher Exact|||Comparison between treatment groups at Week 16||20.64|0.43|0.0325
70880676|NCT00663052|141246017|SUPERIORITY_OR_OTHER||Proportion difference|12.04||||0.0129|TWO_SIDED|95.0|2.1|21.97|||Fisher Exact|||Comparison between treatment groups at Week 20||21.97|2.10|0.0129
70880677|NCT00663052|141246017|SUPERIORITY_OR_OTHER||Proportion difference|11.28||||0.0209|TWO_SIDED|95.0|1.26|21.3|||Fisher Exact|||Comparison between treatment groups at Week 24||21.30|1.26|0.0209
70880678|NCT00663052|141246018|SUPERIORITY_OR_OTHER||Proportion difference|12.1||||0.0461|TWO_SIDED|95.0|-0.24|24.44|||Fisher Exact|||Comparison between treatment groups at Week 2||24.44|-0.24|0.0461
70880679|NCT00663052|141246018|SUPERIORITY_OR_OTHER||Proportion difference|8.83||||0.1314|TWO_SIDED|95.0|-2.44|20.1|||Fisher Exact|||Comparison between treatment groups at Week 4||20.10|-2.44|0.1314
70880680|NCT00663052|141246018|SUPERIORITY_OR_OTHER||Proportion difference|11.2||||0.0289|TWO_SIDED|95.0|0.65|21.74|||Fisher Exact|||Comparison between treatment groups at Week 8||21.74|0.65|0.0289
70880681|NCT00663052|141246018|SUPERIORITY_OR_OTHER||Proportion difference|8.52||||0.0433|TWO_SIDED|95.0|-0.04|17.07|||Fisher Exact|||Comparison between treatment groups at Week 12||17.07|-0.04|0.0433
70880682|NCT00663052|141246018|SUPERIORITY_OR_OTHER||Proportion difference|7.06||||0.0902|TWO_SIDED|95.0|-1.32|15.43|||Fisher Exact|||Comparison between treatment groups at Week 16||15.43|-1.32|0.0902
70880683|NCT00663052|141246018|SUPERIORITY_OR_OTHER||Proportion difference|7.79||||0.063|TWO_SIDED|95.0|-0.68|16.26|||Fisher Exact|||Comparison between treatment groups at Week 20||16.26|-0.68|0.0630
70880684|NCT00663052|141246018|SUPERIORITY_OR_OTHER||Proportion difference|7.7||||0.0907|TWO_SIDED|95.0|-1.53|16.93|||Fisher Exact|||Comparison between treatment groups at Week 24||16.93|-1.53|0.0907
70880685|NCT00663052|141246021|SUPERIORITY_OR_OTHER||Proportion difference|3.25||||0.6255|TWO_SIDED|95.0|-9.39|15.9|||Fisher Exact|||Comparison between treatment groups at Week 2||15.90|-9.39|0.6255
70880686|NCT00663052|141246021|SUPERIORITY_OR_OTHER||Proportion difference|9.3||||0.1292|TWO_SIDED|95.0|-2.85|21.45|||Fisher Exact|||Comparison between treatment groups at Week 4||21.45|-2.85|0.1292
70880687|NCT00663052|141246021|SUPERIORITY_OR_OTHER||Proportion difference|11.86||||0.0251|TWO_SIDED|95.0|0.94|22.78|||Fisher Exact|||Comparison between treatment groups at Week 8||22.78|0.94|0.0251
70880688|NCT00663052|141246021|SUPERIORITY_OR_OTHER||Proportion difference|14.16||||0.0055|TWO_SIDED|95.0|3.68|24.64|||Fisher Exact|||Comparison between treatment groups at Week 12||24.64|3.68|0.0055
70880689|NCT00663052|141246021|SUPERIORITY_OR_OTHER||Proportion difference|11.99||||0.0159|TWO_SIDED|95.0|1.78|22.2|||Fisher Exact|||Comparison between treatment groups at Week 16||22.20|1.78|0.0159
70880690|NCT00663052|141246021|SUPERIORITY_OR_OTHER||Proportion difference|9.05||||0.0672|TWO_SIDED|95.0|-1.08|19.18|||Fisher Exact|||Comparison between treatment groups at Week 20||19.18|-1.08|0.0672
70880691|NCT00663052|141246021|SUPERIORITY_OR_OTHER||Proportion difference|10.51||||0.0351|TWO_SIDED|95.0|0.27|20.75|||Fisher Exact|||Comparison between treatment groups at Week 24||20.75|0.27|0.0351
70880692|NCT00663052|141246022|SUPERIORITY_OR_OTHER||Proportion difference|6.24||||0.2283|TWO_SIDED|95.0|-4.11|16.58|||Fisher Exact|||Comparison between treatment groups at Week 2||16.58|-4.11|0.2283
70880693|NCT00663052|141246022|SUPERIORITY_OR_OTHER||Proportion difference|5.49||||0.2326|TWO_SIDED|95.0|-3.68|14.66|||Fisher Exact|||Comparison between treatment groups at Week 4||14.66|-3.68|0.2326
70880694|NCT00663052|141246022|SUPERIORITY_OR_OTHER||Proportion difference|10.0||||0.0165|TWO_SIDED|95.0|1.47|18.52|||Fisher Exact|||Comparison between treatment groups at Week 8||18.52|1.47|0.0165
70880695|NCT00663052|141246022|SUPERIORITY_OR_OTHER||Proportion difference|10.0||||0.0165|TWO_SIDED|95.0|1.47|18.52|||Fisher Exact|||Comparison between treatment groups at Week 12||18.52|1.47|0.0165
70880696|NCT00663052|141246022|SUPERIORITY_OR_OTHER||Proportion difference|4.85||||0.2536|TWO_SIDED|95.0|-3.46|13.15|||Fisher Exact|||Comparison between treatment groups at Week 16||13.15|-3.46|0.2536
70880697|NCT00663052|141246022|SUPERIORITY_OR_OTHER||Proportion difference|5.6||||0.1761|TWO_SIDED|95.0|-2.59|13.78|||Fisher Exact|||Comparison between treatment groups at Week 20||13.78|-2.59|0.1761
70880698|NCT00663052|141246022|SUPERIORITY_OR_OTHER||Proportion difference|4.01||||0.3943|TWO_SIDED|95.0|-5.18|13.2|||Fisher Exact|||Comparison between treatment groups at Week 24||13.20|-5.18|0.3943
70880699|NCT00663052|141246023|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.3||||0.5748|TWO_SIDED|95.0|-1.5|0.8|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2||0.8|-1.5|0.5748
70880700|NCT00663052|141246023|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-1.2||||0.0471|TWO_SIDED|95.0|-2.4|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4||-0.0|-2.4|0.0471
70880701|NCT00663052|141246023|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-2.0||||0.0025|TWO_SIDED|95.0|-3.3|-0.7|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8||-0.7|-3.3|0.0025
70880702|NCT00663052|141246023|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-2.2||||0.0009|TWO_SIDED|95.0|-3.5|-0.9|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||-0.9|-3.5|0.0009
70880703|NCT00663052|141246023|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-1.9||||0.0015|TWO_SIDED|95.0|-3.1|-0.7|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16||-0.7|-3.1|0.0015
70880704|NCT00663052|141246023|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-1.5||||0.0197|TWO_SIDED|95.0|-2.7|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20||-0.2|-2.7|0.0197
70880705|NCT00663052|141246023|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-1.3||||0.0506|TWO_SIDED|95.0|-2.6|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||0.0|-2.6|0.0506
70880706|NCT00663052|141246024|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|0.04||||0.0435|TWO_SIDED|95.0|0.0|0.09|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||0.09|0.00|0.0435
70880707|NCT00663052|141246024|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|0.05||||0.0275|TWO_SIDED|95.0|0.01|0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||0.10|0.01|0.0275
70880708|NCT00663052|141246025|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|0.0||||0.9473|TWO_SIDED|95.0|-0.7|0.7|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||0.7|-0.7|0.9473
70880709|NCT00663052|141246025|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.1||||0.8217|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||0.6|-0.8|0.8217
70880710|NCT00663052|141246026|SUPERIORITY_OR_OTHER||Difference of Adjusted Mean Change|-0.7||||0.0539|TWO_SIDED|95.0|-1.4|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||0.0|-1.4|0.0539
70880711|NCT00663052|141246026|SUPERIORITY_OR_OTHER||Difference of Adjusted Mean Change|-0.5||||0.1494|TWO_SIDED|95.0|-1.3|0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||0.2|-1.3|0.1494
70880712|NCT00663052|141246032|SUPERIORITY_OR_OTHER|||||||0.2139|TWO_SIDED||||||Fisher Exact|||Comparison between treatment groups at Week 12||||0.2139
70880713|NCT00663052|141246032|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Comparison between treatment groups at Week 24||||1.0000
70880714|NCT00663052|141246034|SUPERIORITY_OR_OTHER|||||||0.2443|TWO_SIDED||||||Fisher Exact|||Comparison between treatment groups at Week 12||||0.2443
70880715|NCT00663052|141246034|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Comparison between treatment groups at Week 24||||1.0000
70880716|NCT00663052|141246035|SUPERIORITY_OR_OTHER|||||||0.0807|TWO_SIDED||||||ANCOVA|||Comparison of treatment groups at Week 12||||0.0807
70880717|NCT00663052|141246035|SUPERIORITY_OR_OTHER|||||||0.1454|TWO_SIDED||||||ANCOVA|||Comparison of treatment groups at Week 24||||0.1454
70880718|NCT05760300|141246036|OTHER||Geometric Least-squares Mean Ratio|84.5|||||TWO_SIDED|90.0|60.1|119.0|||||Parametric (normal theory) analysis of covariance (ANOVA) model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||119|60.1|
70880719|NCT05760300|141246036|OTHER||Geometric Least-squares Mean Ratio|104.0|||||TWO_SIDED|90.0|80.8|133.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||133|80.8|
70880720|NCT05760300|141246037|OTHER||Geometric Least-squares Mean Ratio|106.0|||||TWO_SIDED|90.0|63.6|175.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||175|63.6|
70880721|NCT05760300|141246037|OTHER||Geometric Least-squares Mean Ratio|108.0|||||TWO_SIDED|90.0|77.8|151.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||151|77.8|
70880722|NCT05760300|141246038|OTHER||Geometric Least-squares Mean Ratio|83.8|||||TWO_SIDED|90.0|67.4|104.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||104|67.4|
70960616|NCT03226275|141425606|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|98.68|||||TWO_SIDED|90.0|93.38|104.28||||||Statistical Comparison of Amlodipine in Fasting State||104.28|93.38|
70960617|NCT03226275|141425606|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|98.52|||||TWO_SIDED|90.0|89.75|108.15||||||Statistical Comparison of Bisoprolol in Fed State||108.15|89.75|
70960618|NCT03226275|141425606|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|104.06|||||TWO_SIDED|90.0|96.11|112.66||||||Statistical Comparison of Amlodipine in Fed State||112.66|96.11|
70960619|NCT01340196|141425614|SUPERIORITY_OR_OTHER||Geometric mean ratio|121.89|STANDARD_DEVIATION|14.1|||TWO_SIDED|90.0|111.714|132.999|||ANOVA|No formal testing. Investigation of relative bioavailability.|The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|||132.999|111.714|
70960620|NCT01340196|141425615|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.72|STANDARD_DEVIATION|17.2|||TWO_SIDED|90.0|85.215|105.29|||ANOVA|No formal testing. Investigation of relative bioavailability.|The standard deviation is actually the intra-individual gCV.|||105.290|85.215|
70960621|NCT01340196|141425616|SUPERIORITY_OR_OTHER||Geometric mean ratio|147.12|STANDARD_DEVIATION|14.6||||90.0|134.482|160.943|||ANOVA|No formal testing. Investigation of relative bioavailability.|The standard deviation is actually the intra-individual gCV.|||160.943|134.482|
70960622|NCT01340196|141425617|SUPERIORITY_OR_OTHER||Geometric mean ratio|77.88|STANDARD_DEVIATION|13.4|||TWO_SIDED|90.0|71.24|85.15|||ANOVA|No formal testing. Investigation of relative bioavailability.|The standard deviation is actually the intra-individual gCV.|||85.15|71.24|
70960623|NCT01340196|141425618|SUPERIORITY_OR_OTHER||Geometric mean ratio|81.73|STANDARD_DEVIATION|20.1|||TWO_SIDED|90.0|71.56|93.34|||ANOVA|No formal testing. Investigation of relative bioavailability.|The standard deviation is actually the intra-individual gCV.|||93.34|71.56|
70960624|NCT01340196|141425619|SUPERIORITY_OR_OTHER||Geometric mean ratio|75.27|STANDARD_DEVIATION|13.7|||TWO_SIDED|90.0|68.71|82.45|||ANOVA|No formal testing. Investigation of relative bioavailability.|The standard deviation is actually the intra-individual gCV.|||82.45|68.71|
70960625|NCT00879762|141425630|NON_INFERIORITY|The non-inferiority margin is 2.5. Non-inferiority of Group B is concluded if the upper limit of the 95% confidence interval for the hazard ratio is less than 2.5.|Hazard Ratio (HR)|0.587|||||TWO_SIDED|95.0|0.398|0.868|||||A survival analysis for interval censored data was performed to estimate the hazard ratio. The 95% CI for the hazard ratio was estimated using bootstrap.|Null hypothesis: Median time to seroconversion among participants receiving one standard dose in Group B is 2.5-fold higher compared to participants receiving one high dose in Group A (hazard ratio = 2.5).||0.868|0.398|
70960626|NCT00879762|141425631|NON_INFERIORITY|The non-inferiority margin is 2.5. Non-inferiority of Group B is concluded if the upper limit of the 95% confidence interval for the hazard ratio is less than 2.5.|Hazard Ratio (HR)|0.583|||||TWO_SIDED|95.0|0.384|0.853|||||A survival analysis for interval censored data was performed to estimate the hazard ratio. The 95% CI for the hazard ratio was estimated using bootstrap.|Null hypothesis: Median time to seroconversion among participants receiving one standard dose in Group B is 2.5-fold higher compared to participants receiving one high dose in Group A (hazard ratio = 2.5).||0.853|0.384|
70960627|NCT00879762|141425637|NON_INFERIORITY|The non-inferiority margin is 1. Non-inferiority of Group B is concluded if the upper limit of the 95% confidence interval for the mean difference in the log2.5 transformed peak titers between groups is less than 1.|Mean Difference (Final Values)|0.38|||||TWO_SIDED|95.0|-0.2|0.97|||||Estimate and corresponding 95% confidence interval are calculated on the log2.5 scale.|Null hypothesis: The mean difference in log2.5 transformed peak titers between Group A and Group B \>= 1.||0.97|-0.20|
70960628|NCT00879762|141425638|NON_INFERIORITY|The non-inferiority margin is 1. Non-inferiority of Group B is concluded if the upper limit of the 95% confidence interval for the mean difference in the log2.5 transformed peak titers between groups is less than 1.|Mean Difference (Final Values)|0.42|||||TWO_SIDED|95.0|-0.17|1.0|||||Estimate and corresponding 95% confidence interval are calculated on the log2.5 scale.|Null hypothesis: The mean difference in log2.5 transformed peak titers between Group A and Group B \>= 1.||1.00|-0.17|
70960629|NCT00676065|141425649|NON_INFERIORITY_OR_EQUIVALENCE|The LASS study was designed to analyse rare events (incidence rate \<1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.2|0.9|||||Hazard ratio was adjusted for age, BMI, smoking, hypertension and family history|Tested null hypotheses: the ATE hazard ratio for DRSP/E2 vs. OCs containing LNG is higher or equal to 2.||0.9|0.2|
70960630|NCT00676065|141425649|NON_INFERIORITY_OR_EQUIVALENCE|The LASS study was designed to analyse rare events (incidence rate \<1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.2|0.9|||||Hazard ratio was adjusted for age, BMI, smoking, hypertension and family history|Tested null hypotheses: the ATE hazard ratio for DRSP/E2 vs. OCs containing other progestogens is higher or equal to 2.||0.9|0.2|
70960631|NCT00676065|141425650|NON_INFERIORITY_OR_EQUIVALENCE|The LASS study was designed to analyse rare events (incidence rate \<1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.8|1.7|||||Hazard ratio was adjusted for age, BMI, current duration of use, and family history of VTE.|Tested null hypotheses: the VTE hazard ratio for DRSP/E2 vs. OCs containing LNG is higher or equal to 2.||1.7|0.8|
70960632|NCT00676065|141425650|NON_INFERIORITY_OR_EQUIVALENCE|The LASS study was designed to analyse rare events (incidence rate \<1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.5|1.0|||||Hazard ratio was adjusted for age, BMI, current duration of use, and family history of VTE.|Tested null hypotheses: the VTE hazard ratio for DRSP/E2 vs. OCs containing other progestogens is higher or equal to 2.||1.0|0.5|
70960633|NCT00676065|141425651|NON_INFERIORITY_OR_EQUIVALENCE|The LASS study was designed to analyse rare events (incidence rate \<1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.5|1.4|||||Hazard ratio was adjusted for age, BMI, smoking, educational level and age at menarche.|Tested null hypotheses: the breast cancer hazard ratio for DRSP/E2 vs. OCs containing LNG is higher or equal to 2.||1.4|0.5|
70960634|NCT00676065|141425651|NON_INFERIORITY_OR_EQUIVALENCE|The LASS study was designed to analyse rare events (incidence rate \<1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.6|1.5|||||Hazard ratio was adjusted for age, BMI, smoking, educational level and age at menarche.|Tested null hypotheses: the breast cancer hazard ratio for DRSP/E2 vs. OCs containing other progestogens is higher or equal to 2.||1.5|0.6|
70960635|NCT03401229|141425665|SUPERIORITY||Mean Difference (Net)|-0.57|||<|0.0001|TWO_SIDED|95.0|-0.852|-0.289||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate. Both of the co-primary endpoints were tested at 0.01 (two-sided).|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||The primary analysis compared the changes from baseline of benralizumab with placebo. H0: The change from baseline in total NPS and/or the change from baseline in NBS are similar between benralizumab and placebo. H1: Both of the change from baseline in total NPS and the change from baseline in NBS are different between benralizumab and placebo.||-0.289|-0.852|<0.0001
70960636|NCT03401229|141425666|SUPERIORITY||Mean Difference (Net)|-0.27||||0.0048|TWO_SIDED|95.0|-0.458|-0.083||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate. Both of the co-primary endpoints were tested at 0.01 (two-sided).|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||The primary analysis compared the changes from baseline of benralizumab with placebo. H0: The change from baseline in total NPS and/or the change from baseline in NBS are similar between benralizumab and placebo. H1: Both of the change from baseline in total NPS and the change from baseline in NBS are different between benralizumab and placebo.||-0.083|-0.458|0.0048
70960637|NCT03401229|141425667|SUPERIORITY||Mean Difference (Net)|-5.212||||0.0821|TWO_SIDED|95.0|-11.087|0.664||Since both primary endpoints were significant at significant level of 0.01 level, this endpoint was tested at significant level of 0.05.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline of benralizumab with placebo. H0: The change from baseline in SNOT-22 total score is similar between benralizumab and placebo. H1: The change from baseline in SNOT-22 total score is different between benralizumab and placebo.||0.664|-11.087|0.0821
70960638|NCT03401229|141425668|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.066|TWO_SIDED|95.0|0.55|1.02||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal because test for change from baseline in SNOT-22 at week 40 was not statistically significant.|Regression, Cox|A Cox proportional hazards model including covariates treatment group, region (US/Non-US) and baseline comorbid asthma status.||This endpoint compared the rate of incidence of first NP surgery and/or SCS use for NP between benralizumab and placebo. H0: The rate is similar between benralizumab and placebo. H1: the rate is different between benralizumab and placebo. Hazard ratio is benralizumab vs placebo and HR less than 1 indicates longer time to event||1.02|0.55|0.0660
70960639|NCT03401229|141425669|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.5008|TWO_SIDED|95.0|0.53|1.36||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|Regression, Cox|A Cox proportional hazards model including covariates treatment group, region (US/Non-US) and baseline comorbid asthma status.||The endpoint compared the rate of incidence of first NP surgery between benralizumab and placebo. H0: The rate is similar between benralizumab and placebo. H1: the rate is different between benralizumab and placebo. Hazard ratio (HR) is benralizumab vs placebo and HR less than 1 indicates longer time to event||1.36|0.53|0.5008
70960640|NCT03401229|141425670|SUPERIORITY||Mean Difference (Net)|-0.218||||0.0029|TWO_SIDED|95.0|-0.361|-0.074||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline DSS score of benralizumab with placebo. H0: The change from baseline in DSS score is similar between benralizumab and placebo. H1: The change from baseline in DSS score is different between benralizumab and placebo.||-0.074|-0.361|0.0029
70960641|NCT03401229|141425671|SUPERIORITY||Mean Difference (Net)|-0.475||||0.0054|TWO_SIDED|95.0|-0.81|-0.141||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline of benralizumab with placebo. H0: The change from baseline in NPS is similar between benralizumab and placebo. H1: The change from baseline in NPS is different between benralizumab and placebo.||-0.141|-0.810|0.0054
70960642|NCT03401229|141425672|SUPERIORITY||Mean Difference (Net)|-0.287||||0.0032|TWO_SIDED|95.0|-0.477|-0.096||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline of benralizumab with placebo. H0: The change from baseline in NBS is similar between benralizumab and placebo. H1: The change from baseline in NBS is different between benralizumab and placebo.||-0.096|-0.477|0.0032
70960643|NCT03401229|141425673|SUPERIORITY||Mean Difference (Net)|-7.492||||0.0188|TWO_SIDED|95.0|-13.741|-1.243||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline of benralizumab with placebo. H0: The change from baseline in SNOT-22 total score is similar between benralizumab and placebo. H1: The change from baseline in SNOT-22 total score is different between benralizumab and placebo.||-1.243|-13.741|0.0188
70960644|NCT03401229|141425674|SUPERIORITY||Mean Difference (Net)|-0.237||||0.0023|TWO_SIDED|95.0|-0.389|-0.084||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline DSS score of benralizumab with placebo. H0: The change from baseline in DSS score is similar between benralizumab and placebo. H1: The change from baseline in DSS score is different between benralizumab and placebo.||-0.084|-0.389|0.0023
70960645|NCT03401229|141425675|SUPERIORITY||Mean Difference (Net)|-0.856||||0.2375|TWO_SIDED|95.0|-2.281|0.57||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|ANCOVA|ANCOVA following WP (WP for NP surgery), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status.||This endpoint compared the changes from baseline LMS score of benralizumab with placebo. H0: The change from baseline in LMS score is similar between benralizumab and placebo. H1: The change from baseline in LMS score is different between benralizumab and placebo.||0.570|-2.281|0.2375
70960646|NCT03401229|141425676|SUPERIORITY||Odds Ratio (OR)|0.85||||0.5419|TWO_SIDED|95.0|0.51|1.43||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|Cochran-Mantel-Haenszel|The odds ratio estimate was obtained from the Cochran-Mantel-Haenszel test controlling for region (US/non-US) and baseline comorbid asthma status.||This endpoint compared the proportion of subjects with NP surgery between benralizumab and placebo. H0: The proportion is similar between benralizumab and placebo. H1: The proportion is different between benralizumab and placebo.||1.43|0.51|0.5419
70960647|NCT03401229|141425677|SUPERIORITY||Odds Ratio (OR)|0.69||||0.0913|TWO_SIDED|95.0|0.44|1.06||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|Cochran-Mantel-Haenszel|The odds ratio estimate was obtained from the Cochran-Mantel-Haenszel test controlling for region (US/non-US) and baseline comorbid asthma status.||This endpoint compared the proportion of subjects with SCS\_NP between benralizumab and placebo. H0: The proportion is similar between benralizumab and placebo. H1: The proportion is different between benralizumab and placebo.||1.06|0.44|0.0913
70960648|NCT03401229|141425678|SUPERIORITY||Odds Ratio (OR)|0.65||||0.0362|TWO_SIDED|95.0|0.44|0.97||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|Cochran-Mantel-Haenszel|The odds ratio estimate was obtained from the Cochran-Mantel-Haenszel test controlling for region (US/non-US) and baseline comorbid asthma status.||This endpoint compared the proportion of subjects with NP surgery or SCS\_NP between benralizumab and placebo. H0: The proportion is similar between benralizumab and placebo. H1: The proportion is different between benralizumab and placebo.||0.97|0.44|0.0362
70960649|NCT03401229|141425679|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.1505|TWO_SIDED|95.0|0.53|1.1||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|Regression, Cox|A Cox proportional hazards model including covariates treatment group, region (US/Non-US) and baseline comorbid asthma status.||The endpoint compared the rate of incidence of SCS\_NP use between benralizumab and placebo. H0: The rate is similar between benralizumab and placebo. H1: the rate is different between benralizumab and placebo. Hazard ratio (HR) is benralizumab vs placebo and HR less than 1 indicates longer time to event||1.10|0.53|0.1505
70960650|NCT03401229|141425683|SUPERIORITY||Rate Ratio|0.79||||0.2189|TWO_SIDED|95.0|0.54|1.15||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|Negative Bionomial Model|Model included treatment, US/non-US and prior use of SCS\_NP with total number of courses of SCS\_NP as outcome and log of follow-up time as an offset||The endpoint compared the rate of SCS\_NP use between benralizumab and placebo. H0: The rate is similar between benralizumab and placebo. H1: the rate is different between benralizumab and placebo. Rate ratio is benralizumab vs placebo and Rate ratio less than 1 indicates less likely of SCS\_NP use.||1.15|0.54|0.2189
70960651|NCT03401229|141425684|SUPERIORITY||Median Difference (Net)|-1.854||||0.0036|TWO_SIDED|95.0|-3.101|-0.608||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline score between benralizumab and placebo. H0: The change from baseline score is similar between benralizumab and placebo. H1: The change from baseline score is different between benralizumab and placebo.||-0.608|-3.101|0.0036
70880723|NCT05760300|141246038|OTHER||Geometric Least-squares Mean Ratio|100.0|||||TWO_SIDED|90.0|56.2|179.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||179|56.2|
70880724|NCT05760300|141246039|OTHER||Geometric Least-squares Mean Ratio|96.5|||||TWO_SIDED|90.0|65.1|143.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||143|65.1|
70960652|NCT03401229|141425685|SUPERIORITY||Mean Difference (Net)|-0.166||||0.0941|TWO_SIDED|95.0|-0.36|0.028||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline score between benralizumab and placebo. H0: The change from baseline score is similar between benralizumab and placebo. H1: The change from baseline score is different between benralizumab and placebo.||0.028|-0.360|0.0941
70960653|NCT03401229|141425686|SUPERIORITY||Mean Difference (Net)|-0.213||||0.0246|TWO_SIDED|95.0|-0.399|-0.027||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline score between benralizumab and placebo. H0: The change from baseline score is similar between benralizumab and placebo. H1: The change from baseline score is different between benralizumab and placebo.||-0.027|-0.399|0.0246
70960654|NCT03401229|141425687|SUPERIORITY||Mean Difference (Net)|0.672||||0.5833|TWO_SIDED|95.0|-1.73|3.074||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline score between benralizumab and placebo. H0: The change from baseline score is similar between benralizumab and placebo. H1: The change from baseline score is different between benralizumab and placebo.||3.074|-1.730|0.5833
70960655|NCT03401229|141425688|SUPERIORITY||Median Difference (Net)|2.684||||0.0619|TWO_SIDED|95.0|-0.134|5.502||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline score between benralizumab and placebo. H0: The change from baseline score is similar between benralizumab and placebo. H1: The change from baseline score is different between benralizumab and placebo.||5.502|-0.134|0.0619
70960656|NCT03401229|141425689|SUPERIORITY||Median Difference (Net)|-5.057||||0.102|TWO_SIDED|95.0|-11.129|1.015||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|ANCOVA|Following WP (WP for NP surgery rescued subjects), model included treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline score between benralizumab and placebo. H0: The change from baseline score is similar between benralizumab and placebo. H1: The change from baseline score is different between benralizumab and placebo.||1.015|-11.129|0.1020
70960657|NCT01287065|141425722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.377|||||TWO_SIDED|90.0|0.293|0.462|||Mixed Models Analysis||Mean difference =FF/VI 100/25 µg PM minus Placebo|||0.462|0.293|
70960658|NCT01287065|141425722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.422|||||TWO_SIDED|90.0|0.337|0.507|||Mixed Models Analysis||Mean difference =FF/VI 100/25 µg AM minus Placebo|||0.507|0.337|
70960659|NCT01287065|141425722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044|||||TWO_SIDED|90.0|-0.125|0.036|||Mixed Models Analysis||Mean difference =FF/VI 100/25 µg AM minusFF/VI 100/25 µg PM|||0.036|-0.125|
70960660|NCT02875977|141425726|SUPERIORITY||Odds Ratio (OR)|1.794||||0.17|TWO_SIDED|95.0|0.782|4.119|||Regression, Logistic|||The null hypothesis is that there is no difference in the odds of completing half of the recommended PFPT visits between those assigned to standard versus experimental counseling||4.119|0.782|0.17
70960661|NCT02875977|141425727|SUPERIORITY||Odds Ratio (OR)|0.564||||0.056|TWO_SIDED|95.0|0.314|1.014|||Regression, Logistic|||The null hypothesis is that there is no difference in the odds of initiating PFPT between those assigned to standard versus experimental counseling||1.014|0.314|0.056
70960662|NCT02875977|141425728|SUPERIORITY||Odds Ratio (OR)|1.044||||0.9|TWO_SIDED|95.0|0.517|2.11|||Regression, Logistic|The statistical test of the hypothesis excludes the three individuals with unknown PFPT discharge status||The null hypothesis is that there is no difference in the odds of discharge from PFPT between those assigned to standard versus experimental counseling||2.110|0.517|0.90
70960663|NCT02875977|141425729|SUPERIORITY||Z-Score|-1.4262||||0.16|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Among those who initiated PFPT therapy, the null hypothesis is that there is no difference in the number of days to initiating PFPT therapy between those assigned to standard versus experimental counseling||||0.16
70960664|NCT02875977|141425730|SUPERIORITY||Mean Difference (Final Values)|-4.456|STANDARD_ERROR_OF_MEAN|6.5481||0.5|TWO_SIDED|95.0|-17.6149|8.7028|||t-test, 2 sided|||The null hypothesis is that there is no difference in the change from pre-PFPT to post-PFPT UDI-6 scores between those assigned to standard versus experimental counseling||8.7028|-17.6149|0.50
70960665|NCT01259726|141425732|SUPERIORITY_OR_OTHER_LEGACY||||||<=|0.0001|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||<=0.0001
70960666|NCT01259726|141425732|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||<0.0001
70960667|NCT01259726|141425732|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||<0.0001
70960668|NCT01259726|141425733|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.088|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.088
70960669|NCT01259726|141425733|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.002|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.002
70960670|NCT01259726|141425733|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.088|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.088
70960671|NCT01259726|141425734|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.054|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.054
70960672|NCT01259726|141425734|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.008|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.008
70960673|NCT01259726|141425734|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.101|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.101
70960674|NCT01259726|141425735|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.045|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.045
70960675|NCT01259726|141425735|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.066|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.066
70960676|NCT01259726|141425735|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.045|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.045
70960677|NCT02168842|141425773|EQUIVALENCE|Comparison of the risk of need for antiparkinsonian therapy in Isradipine group to the risk in placebo group.|Hazard Ratio (HR)|0.79||||0.073|TWO_SIDED|95.0|0.61|1.03|||Log Rank|||||1.03|0.61|0.073
70960678|NCT02168842|141425774|EQUIVALENCE|Comparison the risk of need for dyskinesia in Isradipine group to the risk in a placebo group.|Hazard Ratio (HR)|1.53||||0.21|TWO_SIDED|95.0|0.78|3.01|||Log Rank|||||3.01|0.78|0.21
70960679|NCT02168842|141425775|EQUIVALENCE|Comparison of the risk of need for antiparkinsonian therapy in Isradipine group to the risk in placebo group.|Hazard Ratio (HR)|0.83||||0.35|TWO_SIDED|95.0|0.56|1.22|||Log Rank|||||1.22|0.56|0.35
70960680|NCT00325039|141425783|NON_INFERIORITY_OR_EQUIVALENCE|This study was an equivalence trial and was designed to have 80% power to show equivalence between the two sling procedures, with an equivalence margin of +/- 12 percentage points, at a two-sided significance level of 5%. The margin of +/- 12 was chosen on the basis of clinical considerations and a calculation of the number of patients it was feasible to enroll in the trial.|difference in success rate (RMUS-TMUS)|3.0|||||TWO_SIDED|95.0|-3.6|9.6||||||With 294 women/arm, the study would have 80% power to show equivalence between the two procedures, with an equivalence margin of +/- 12 percentage points, at a two-sided significance level of 5%. A planned time-to-event interim analysis of the primary outcome (objective treatment success) was conducted when 33% of the anticipated treatment failures occurred. We adjusted the primary outcome analysis for this interim look by assigning nominal alpha values of 0.049 to the 95% confidence intervals.||9.6|-3.6|
70960681|NCT00325039|141425784|SUPERIORITY_OR_OTHER||Difference in proportions|-4.1||||0.14||95.0||||This was not adjusted for multiple comparisons; the a priori threshold for statistical significance was 0.05.|Chi-squared|||Although the primary aim of the study was designed as an equivalence trial, the secondary aims were considered as superiority tests.||||0.14
70960682|NCT00325039|141425785|NON_INFERIORITY_OR_EQUIVALENCE|This study was an equivalence trial and was designed to have 80% power to show equivalence between the two sling procedures, with an equivalence margin of +/- 12 percentage points, at a two-sided significance level of 5%. The margin of +/- 12 was chosen on the basis of clinical considerations and a calculation of the number of patients it was feasible to enroll in the trial.|difference in success (RMUS - TMUS)|6.4|||||TWO_SIDED|95.0|-1.6|14.3||||||With 294 women/arm, the study would have 80% power to show equivalence between the two procedures, with an equivalence margin of +/- 12 percentage points, at a two-sided significance level of 5%. A planned time-to-event interim analysis of the primary outcome (objective treatment success) was conducted when 33% of the anticipated treatment failures occurred. We adjusted the primary outcome analysis for this interim look by assigning nominal alpha values of 0.049 to the 95% confidence intervals.||14.3|-1.6|
70960683|NCT00325039|141425786|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||t-test, 2 sided|||The null hypothesis is that the two arms do not differ according to quality of life, as measured by the IIQ.||||0.47
70960684|NCT00325039|141425787|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||t-test, 2 sided|||The UDI measure was compared using a two-sample t test.||||0.41
70960685|NCT00426153|141425791|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||Rank-sum test|||P values \<0.05 were considered statistically significant.||||0.048
70960686|NCT00426153|141425792|SUPERIORITY_OR_OTHER|||||||0.045||95.0||||P values \< 0.05 were considered statistically significant|Rank sum|||||||0.045
70960687|NCT00426153|141425793|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||P Values \< 0.05 were considered statistically significant|Rank sum|||||||0.98
70960688|NCT00343252|141425808|SUPERIORITY_OR_OTHER|||||||0.642||95.0||||All comparisons were conducted using a 2-sided significance level of 0.05.|Chi-square|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of worst back pain from baseline to the 6-month endpoint.||||0.642
70960689|NCT00343252|141425809|SUPERIORITY_OR_OTHER|||||||0.683||95.0||||All comparisons were conducted using a 2-sided significance level of 0.05.|Chi-square|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of worst back pain from baseline at the 12-month endpoint.||||0.683
70960690|NCT00343252|141425810|SUPERIORITY_OR_OTHER|||||||0.809||95.0||||All comparisons were conducted using a 2-sided significance level of 0.05.|Chi-square|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of average back pain from baseline to the 6-month endpoint.||||0.809
70960691|NCT00343252|141425811|SUPERIORITY_OR_OTHER|||||||0.986||95.0||||All comparisons were conducted using a 2-sided significance level of 0.05.|Chi-square|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of average back pain from baseline to the 12-month endpoint.||||0.986
70960692|NCT00343252|141425812|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.746|TWO_SIDED|95.0|0.85|1.26||Comparison of the Kaplan-Meier survival curves between treatment groups was conducted using log-rank, significance level of 0.05.|Log Rank|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a \>=30% reduction in worst back pain at the 6-month endpoint.||1.26|0.85|0.746
70960693|NCT00343252|141425813|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.719|TWO_SIDED|95.0|0.86|1.25||Comparison of the Kaplan-Meier survival curves between treatment groups was conducted using log-rank, significance level of 0.05.|Log Rank|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a \>=30% reduction in worst back pain at the 12-month endpoint.||1.25|0.86|0.719
70960694|NCT00343252|141425814|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.681|TWO_SIDED|95.0|0.86|1.26||Comparison of the Kaplan-Meier survival curves between treatment groups was conducted using log-rank, significance level of 0.05.|Log Rank|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a \>=30% reduction for average back pain at the 6-month endpoint.||1.26|0.86|0.681
70960695|NCT00343252|141425815|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.789|TWO_SIDED|95.0|0.86|1.23||Comparison of the Kaplan-Meier survival curves between treatment groups was conducted using log-rank, significance level of 0.05.|Log Rank|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a \>=30% reduction in average back pain at the 12-month endpoint.||1.23|0.86|0.789
70960696|NCT00343252|141425816|SUPERIORITY_OR_OTHER|||||||0.968||95.0||||No adjustments for multiplicity were performed.|ANCOVA|The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.||Tested the null hypothesis that there is no statistically significant difference between the treatment groups in the proportion of participants with a reduction in disability at the 3-month endpoint.||||0.968
70960697|NCT00343252|141425817|SUPERIORITY_OR_OTHER|||||||0.568||95.0||||No adjustments for multiplicity were performed.|ANCOVA|The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with a reduction in disability at the 6-month endpoint.||||0.568
70960698|NCT00343252|141425818|SUPERIORITY_OR_OTHER|||||||0.932||95.0||||No adjustments for multiplicity were performed.|ANCOVA|The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with a reduction in disability at the 12-month endpoint.||||0.932
70960699|NCT00343252|141425819|SUPERIORITY_OR_OTHER|||||||0.814||95.0||||No adjustments for multiplicity were performed.|ANCOVA|The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with an improvement in quality of life at the 6-month endpoint.||||0.814
70960700|NCT00343252|141425820|SUPERIORITY_OR_OTHER|||||||0.572||95.0||||No adjustments for multiplicity were performed.|ANCOVA|The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with an improvement in quality of life at the 12-month endpoint.||||0.572
70960701|NCT00343252|141425823|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||P-value is for responder versus non-responder.|Chi-squared|||||||0.600
70960702|NCT00343252|141425824|SUPERIORITY_OR_OTHER|||||||0.399||95.0||||P-value is for responder versus non-responder.|Chi-squared|||||||0.399
70960703|NCT00343252|141425825|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.453|TWO_SIDED|95.0|0.89|1.28|||Log Rank|||||1.28|0.89|0.453
70960704|NCT00343252|141425826|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.353|TWO_SIDED|95.0|0.91|1.3|||Log Rank|||||1.30|0.91|0.353
70960705|NCT00343252|141425827|SUPERIORITY_OR_OTHER|||||||0.943||95.0|||||ANCOVA|||||||0.943
70960706|NCT00343252|141425828|SUPERIORITY_OR_OTHER|||||||0.553||95.0|||||ANCOVA|||||||0.553
70960707|NCT00307125|141425925|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Fisher Exact|||Analysis by Fisher's exact test counting participants with 50% decrease in anti-HLA antibodies at any time within 12 months post treatment initiation||||>0.999
70960708|NCT00307125|141425930|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Fisher Exact|||||||>0.999
70960709|NCT00307125|141425931|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Fisher Exact|||||||>0.999
70960710|NCT00051363|141425933|SUPERIORITY_OR_OTHER|||||||0.0074||||||"2M E/F Function- SWMT-OMD; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).~After correction for multiple comparisons (sequential Bonferroni) P Value=0.0444 (NS)"|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||Comparison of means (regression estimates) between arms for 2M E/F Function- SWMT-OMD.||||0.0074
70960711|NCT00051363|141425933|SUPERIORITY_OR_OTHER|||||||0.2254||||||6M E/F Function- SWMT-OMD; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||Comparison of means (regression estimates) between arms for 6M E/F Function- SWMT-OMD.||||0.2254
70960712|NCT00051363|141425934|SUPERIORITY_OR_OTHER|||||||0.4538||||||DX A/P Function- PFN-TOTL; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Parametric survival analysis|Parametric survival analyses were conducted using by-visit comparisons for A/P Function- PFN-TOTL since these data were right censored at 60.||"Comparison of means (regression estimates) between arms for DX A/P Function- PFN-TOTL.~Data were reciprocal transformed for analysis and back-transformed for reporting."||||0.4538
70960713|NCT00051363|141425934|SUPERIORITY_OR_OTHER|||||||0.086||||||2M A/P Function- PFN-TOTL; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Parametric survival analysis|Parametric survival analyses were conducted using by-visit comparisons for A/P Function- PFN-TOTL since these data were right censored at 60.||"Comparison of means (regression estimates) between arms for 2M A/P Function- PFN-TOTL.~Data were reciprocal transformed for analysis and back-transformed for reporting."||||0.0860
70960714|NCT00051363|141425934|SUPERIORITY_OR_OTHER|||||||0.2103||||||6M A/P Function- PFN-TOTL; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Parametric survival analysis|Parametric survival analyses were conducted using by-visit comparisons for A/P Function- PFN-TOTL since these data were right censored at 60.||"Comparison of means (regression estimates) between arms for 6M A/P Function- PFN-TOTL.~Data were reciprocal transformed for analysis and back-transformed for reporting."||||0.2103
70960715|NCT00051363|141425935|SUPERIORITY_OR_OTHER|||||||0.7936||||||DX L/M Function- BSRT-SR; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||Comparison of means (regression estimates) between arms for DX L/M Function- BSRT-SR.||||0.7936
70960716|NCT00051363|141425935|SUPERIORITY_OR_OTHER|||||||0.5444||||||2M L/M Function- BSRT-SR; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||Comparison of means (regression estimates) between arms for 2M L/M Function- BSRT-SR.||||0.5444
70960717|NCT00051363|141425935|SUPERIORITY_OR_OTHER|||||||0.7569||||||6M L/M Function- BSRT-SR; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||Comparison of means (regression estimates) between arms for 6M L/M Function- BSRT-SR.||||0.7569
70960718|NCT00051363|141425936|SUPERIORITY_OR_OTHER|||||||0.5606||||||"2M L/M Function- PN-RT (Mild OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."||||0.5606
70960719|NCT00051363|141425936|SUPERIORITY_OR_OTHER|||||||0.6487||||||"2M L/M Function- PN-RT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."||||0.6487
70960720|NCT00051363|141425936|SUPERIORITY_OR_OTHER|||||||0.5667||||||"2M L/M Function- PN-RT (Severe OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."||||0.5667
70880725|NCT05760300|141246039|OTHER||Geometric Least-squares Mean Ratio|77.8|||||TWO_SIDED|90.0|42.7|142.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||142|42.7|
70960721|NCT00051363|141425936|SUPERIORITY_OR_OTHER|||||||0.3972||||||"6M L/M Function- PN-RT (Mild OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."||||0.3972
70960722|NCT00051363|141425936|SUPERIORITY_OR_OTHER|||||||0.3973||||||"6M L/M Function- PN-RT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."||||0.3973
70880726|NCT05760300|141246044|OTHER||Geometric Least-squares Mean Ratio|160.0|||||TWO_SIDED|90.0|97.2|263.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 1||263|97.2|
70880727|NCT05760300|141246044|OTHER||Geometric Least-squares Mean Ratio|65.9|||||TWO_SIDED|90.0|35.0|124.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 6||124|35.0|
70880728|NCT05760300|141246044|OTHER||Geometric Least-squares Mean Ratio|86.7|||||TWO_SIDED|90.0|53.3|141.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 1||141|53.3|
70880729|NCT05760300|141246044|OTHER||Geometric Least-squares Mean Ratio|72.6|||||TWO_SIDED|90.0|50.4|105.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 6||105|50.4|
70880730|NCT05760300|141246045|OTHER||Geometric Least-squares Mean Ratio|139.0|||||TWO_SIDED|90.0|87.8|221.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 1||221|87.8|
70880731|NCT05760300|141246045|OTHER||Geometric Least-squares Mean Ratio|66.8|||||TWO_SIDED|90.0|37.3|120.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 6||120|37.3|
70880732|NCT05760300|141246045|OTHER||Geometric Least-squares Mean Ratio|85.7|||||TWO_SIDED|90.0|54.5|135.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 1||135|54.5|
70880733|NCT05760300|141246045|OTHER||Geometric Least-squares Mean Ratio|70.3|||||TWO_SIDED|90.0|49.4|100.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 6||100|49.4|
70880734|NCT05760300|141246046|OTHER||Geometric Least-squares Mean Ratio|84.2|||||TWO_SIDED|90.0|32.7|217.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 1||217|32.7|
70880735|NCT05760300|141246046|OTHER||Geometric Least-squares Mean Ratio|58.0|||||TWO_SIDED|90.0|30.1|112.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 6||112|30.1|
70880736|NCT05760300|141246046|OTHER||Geometric Least-squares Mean Ratio|85.6|||||TWO_SIDED|90.0|54.1|135.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 1||135|54.1|
70880737|NCT05760300|141246046|OTHER||Geometric Least-squares Mean Ratio|69.6|||||TWO_SIDED|90.0|48.9|99.2|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 6||99.2|48.9|
70880738|NCT00877058|141246049|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27|||<|0.05|TWO_SIDED|95.0|0.15|0.48|||Chi-squared|||||0.48|0.15|<0.05
70880739|NCT00877058|141246049|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.001|TWO_SIDED|0.05|0.24|0.68|||Chi-squared|||||0.68|0.24|0.001
70880740|NCT00877058|141246050|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56|||<|0.05|TWO_SIDED|95.0|0.96|2.52|||Chi-squared|||||2.52|0.96|<0.05
70880741|NCT00877058|141246050|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28|||<|0.05|TWO_SIDED|95.0|0.79|2.08|||Chi-squared|||||2.08|0.79|<0.05
70880742|NCT00877058|141246051|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55|||<|0.05|TWO_SIDED|95.0|0.31|0.97|||Chi-squared|||||0.97|0.31|<0.05
70880743|NCT00877058|141246051|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58|||<|0.05|TWO_SIDED|95.0|0.33|1.02|||Chi-squared|||||1.02|0.33|<0.05
70880744|NCT03628703|141246056|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||||||0.49
70880745|NCT04350788|141246061|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||We analyzed program satisfaction between SCP and ESCP by role (patient vs partner). The following result is for patient.||||0.02
70880746|NCT04350788|141246061|SUPERIORITY|||||||0.25|||||||t-test, 1 sided|||We analyzed program satisfaction between SCP and ESCP by role (patient vs partner). The following result is for partner.||||0.25
70880747|NCT04350788|141246062|SUPERIORITY|||||||0.36|||||||t-test, 1 sided|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in general domain.||||0.36
70880748|NCT04350788|141246062|SUPERIORITY|||||||0.38|||||||t-test, 1 sided|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in content domain.||||0.38
70880749|NCT04350788|141246062|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in navigation domain.||||0.02
70880750|NCT04350788|141246062|SUPERIORITY|||||||0.62|||||||t-test, 1 sided|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in general domain.||||0.62
70880751|NCT04350788|141246062|SUPERIORITY|||||||0.65|||||||t-test, 1 sided|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in content domain.||||0.65
70880752|NCT04350788|141246062|SUPERIORITY|||||||0.45|||||||t-test, 1 sided|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in navigation domain.||||0.45
70880753|NCT04350788|141246063|SUPERIORITY|||||||0.35|||||||Mixed Models Analysis|||||||0.35
70880754|NCT04350788|141246064|SUPERIORITY|||||||0.01|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in urinary domain.||||0.01
70880755|NCT04350788|141246064|SUPERIORITY|||||||0.41|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in bowel domain.||||0.41
70880756|NCT04350788|141246064|SUPERIORITY|||||||0.21|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in sexual domain.||||0.21
70880757|NCT04350788|141246064|SUPERIORITY|||||||0.52|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in hormonal domain.||||0.52
70960723|NCT00051363|141425936|SUPERIORITY_OR_OTHER|||||||0.3055||||||"6M L/M Function- PN-RT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."||||0.3055
70960724|NCT00051363|141425937|SUPERIORITY_OR_OTHER|||||||0.3699||||||"2M A/P Function- PVT-MedRT (Mild OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.3699
70960725|NCT00051363|141425937|SUPERIORITY_OR_OTHER|||||||0.9673||||||"2M A/P Function- PVT-MedRT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.9673
70960726|NCT00051363|141425937|SUPERIORITY_OR_OTHER|||||||0.3426||||||"2M A/P Function- PVT-MedRT (Severe OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.3426
70960727|NCT00051363|141425937|SUPERIORITY_OR_OTHER|||||||0.3901||||||"6M A/P Function- PVT-MedRT (Mild OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.3901
70960728|NCT00051363|141425937|SUPERIORITY_OR_OTHER|||||||0.9464||||||"6M A/P Function- PVT-MedRT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.9464
70960729|NCT00051363|141425937|SUPERIORITY_OR_OTHER|||||||0.4372||||||"6M A/P Function- PVT-MedRT (Severe OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.4372
70880758|NCT04350788|141246064|SUPERIORITY|||||||0.79|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in urinary domain.||||0.79
70880759|NCT04350788|141246064|SUPERIORITY|||||||0.84|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in bowel domain.||||0.84
70960730|NCT00051363|141425938|SUPERIORITY_OR_OTHER|||||||0.9656||||||"2M A/P Function- PVT-Slo10%RT (Mild OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.9656
70960731|NCT00051363|141425938|SUPERIORITY_OR_OTHER|||||||0.6765||||||"2M A/P Function- PVT-Slo10%RT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.6765
70960732|NCT00051363|141425938|SUPERIORITY_OR_OTHER|||||||0.5288||||||"2M A/P Function- PVT-Slo10%RT (Severe OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.5288
70960733|NCT00051363|141425938|SUPERIORITY_OR_OTHER|||||||0.7807||||||"6M A/P Function- PVT-Slo10%RT (Mild OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.7807
70960734|NCT00051363|141425938|SUPERIORITY_OR_OTHER|||||||0.9603||||||"6M A/P Function- PVT-Slo10%RT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.9603
70960735|NCT00051363|141425938|SUPERIORITY_OR_OTHER|||||||0.3075||||||"6M A/P Function- PVT-Slo10%RT (Severe OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.3075
70960736|NCT00051363|141425939|SUPERIORITY_OR_OTHER|||||||0.4262||||||2M L/M Function- BSRTDR-TotRec (Mild OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."||||0.4262
70960737|NCT00051363|141425939|SUPERIORITY_OR_OTHER|||||||0.3161||||||2M L/M Function- BSRTDR-TotRec (Moderate OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."||||0.3161
70960738|NCT00051363|141425939|SUPERIORITY_OR_OTHER|||||||0.1835||||||2M L/M Function- BSRTDR-TotRec (Severe OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."||||0.1835
70960739|NCT00051363|141425939|SUPERIORITY_OR_OTHER|||||||0.2462||||||6M L/M Function- BSRTDR-TotRec (Mild OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."||||0.2462
70960740|NCT00051363|141425939|SUPERIORITY_OR_OTHER|||||||0.2069||||||6M L/M Function- BSRTDR-TotRec (Moderate OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."||||0.2069
70960741|NCT00051363|141425939|SUPERIORITY_OR_OTHER|||||||0.5235||||||6M L/M Function- BSRTDR-TotRec (Severe OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."||||0.5235
70960742|NCT00051363|141425940|SUPERIORITY_OR_OTHER|||||||0.5419||||||2M E/F Function- SWMT-BehMD (Mild OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.5419
70960743|NCT00051363|141425940|SUPERIORITY_OR_OTHER|||||||0.89||||||2M E/F Function- SWMT-BehMD (Moderate OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.8900
70960744|NCT00051363|141425940|SUPERIORITY_OR_OTHER|||||||0.0031||||||2M E/F Function- SWMT-BehMD (Severe OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.0031
70960745|NCT00051363|141425940|SUPERIORITY_OR_OTHER|||||||0.8703||||||6M E/F Function- SWMT-BehMD (Mild OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.8703
70960746|NCT00051363|141425940|SUPERIORITY_OR_OTHER|||||||0.1838||||||6M E/F Function- SWMT-BehMD (Moderate OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.1838
70960747|NCT00051363|141425940|SUPERIORITY_OR_OTHER|||||||0.0739||||||6M E/F Function- SWMT-BehMD (Severe OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.0739
70960748|NCT00051363|141425941|SUPERIORITY_OR_OTHER|||||||0.045||||||2M E/F Function- SWMT-ActMD (Mild OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.0450
70960749|NCT00051363|141425941|SUPERIORITY_OR_OTHER|||||||0.4512||||||2M E/F Function- SWMT-ActMD (Moderate OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.4512
70960750|NCT00051363|141425941|SUPERIORITY_OR_OTHER|||||||0.6672||||||2M E/F Function- SWMT-ActMD (Severe OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.6672
70960751|NCT00051363|141425941|SUPERIORITY_OR_OTHER|||||||0.8197||||||6M E/F Function- SWMT-ActMD (Mild OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.8197
70960752|NCT00051363|141425941|SUPERIORITY_OR_OTHER|||||||0.989||||||6M E/F Function- SWMT-ActMD (Moderate OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.9890
70960753|NCT00051363|141425941|SUPERIORITY_OR_OTHER|||||||0.5029||||||6M E/F Function- SWMT-ActMD (Severe OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.5029
70960754|NCT00051363|141425942|SUPERIORITY_OR_OTHER|||||||0.9518||||||2M E/F Function- SAT-D-NumRuCh (Mild OSA); P\<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (\<=2 vs. \>=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.9518
70960755|NCT00051363|141425942|SUPERIORITY_OR_OTHER|||||||0.4108||||||2M E/F Function- SAT-D-NumRuCh (Moderate OSA); P\<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (\<=2 vs. \>=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.4108
70960756|NCT00051363|141425942|SUPERIORITY_OR_OTHER|||||||0.4528||||||2M E/F Function- SAT-D-NumRuCh (Severe OSA); P\<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (\<=2 vs. \>=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.4528
70880760|NCT04350788|141246064|SUPERIORITY|||||||0.82|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in sexual domain.||||0.82
70880761|NCT04350788|141246064|SUPERIORITY|||||||0.33|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in hormonal domain.||||0.33
70880762|NCT04350788|141246065|SUPERIORITY|||||||0.18|||||||ANCOVA|||||||0.18
70880763|NCT04350788|141246065|SUPERIORITY|||||||0.38|||||||ANCOVA|||||||0.38
70880764|NCT04350788|141246066|SUPERIORITY|||||||0.05|||||||generalized linear regression|||||||0.05
70880765|NCT04350788|141246067|SUPERIORITY|||||||0.1|||||||Mixed Models Analysis|||||||0.10
70880766|NCT04350788|141246068|SUPERIORITY|||||||0.29|||||||Mixed Models Analysis|||||||0.29
70880767|NCT04350788|141246069|SUPERIORITY|||||||0.49|||||||Mixed Models Analysis|||||||0.49
70880768|NCT04350788|141246070|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
70880769|NCT04350788|141246071|SUPERIORITY|||||||0.16|||||||Mixed Models Analysis|||||||0.16
70880770|NCT04350788|141246072|SUPERIORITY|||||||0.55|||||||Mixed Models Analysis|||||||0.55
70880771|NCT02967692|141246130|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.042|TWO_SIDED|95.0|0.655|1.027|||Log Rank|||||1.027|0.655|0.042
70880772|NCT02967692|141246138|SUPERIORITY||Hazard Ratio (HR)|1.183||||0.2975|TWO_SIDED|95.0|0.865|1.619|||Log Rank|||||1.619|0.865|0.2975
70880773|NCT04916600|141246155|SUPERIORITY||Difference in percentages|22.0||||0.043|TWO_SIDED|||||The threshold for statistical significance was p = .05|Chi-squared||Treatment difference = Active device \>=24 hour group - remainder of participants (Active \<24 hr, Sham \>=24 hr, and Sham \<24 hr groups)|||||.043
70880774|NCT04916600|141246156|SUPERIORITY||Mean Difference (Net)|-3.4||||0.032|TWO_SIDED|||||The threshold for statistical significance was p = .05|t-test, 2 sided|df=101||||||.032
70880775|NCT02094716|141246251|SUPERIORITY|||||||0.6084|||||||Chi-squared|||||||0.6084
70880776|NCT02094716|141246253|SUPERIORITY|||||||0.6937|||||||Chi-squared|||||||0.6937
70880777|NCT02094716|141246254|SUPERIORITY|||||||0.101|||||||Fisher Exact|||||||0.1010
70880778|NCT02094716|141246254|SUPERIORITY|||||||0.0764|||||||Fisher Exact|||||||0.0764
70880779|NCT02310919|141246266|NON_INFERIORITY|For the non-inferiority hypothesis testing of the primary outcome, a one-sided 95% CI was constructed for the relative risk. The alternative trigger will be considered non-inferior to the standard trigger if the lower bound of the one-sided CI of the relative risk is not less than 0.8 (i.e. risk reduction limit of 20%).|Risk Ratio (RR)|0.91|||||ONE_SIDED|95.0|0.83|||Using the standard trigger as the reference, the relative risk (i.e. risk ratio) (RR) with 95% confidence interval (CI) for the probability of the outcome was calculated using log-binomial regression models with application of GEE.|log-binomial regression with GEE||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|The alternative trigger will be considered non-inferior to the standard hCG trigger if it is at least 80% as effective at inducing oocyte competence. Considering a cluster size of 15 oocytes and an estimated intra-cluster correlation of 0.1, we calculated that approximately 50 participants were needed in each study arm when the non-inferiority difference is -0.1 (i.e. 20% of 0.5 total competent proportion) with a power of 0.8 and a one-sided alpha of 0.05.|||0.83|
70880780|NCT02310919|141246267|SUPERIORITY||Risk Ratio (RR)|0.85||||0.06|TWO_SIDED|95.0|0.71|1.01||The statistical significance was based on a two-sided alpha of 0.05.|generalized linear model with log link|Comparison was done using generalized linear modeling with log link function|The numerator was the outcome with the alternative trigger, and the denominator was the outcome with the standard trigger.|The null hypothesis was that there would be no difference in number of oocytes retrieved between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||1.01|0.71|0.06
70880781|NCT02310919|141246268|SUPERIORITY||Risk Ratio (RR)|0.87||||0.13|TWO_SIDED|95.0|0.72|1.04||The statistical significance was based on a two-sided alpha of 0.05.|generalized linear model with log link|Comparison was done using generalized linear modeling with log link function.|The numerator was the outcome with the alternative trigger, and the denominator was the outcome with the standard trigger.|The null hypothesis was that there would be no difference in the number of MII oocytes retrieved between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||1.04|0.72|0.13
70880782|NCT02310919|141246269|SUPERIORITY||Risk Ratio (RR)|0.97||||0.47|TWO_SIDED|95.0|0.9|1.05||The statistical significance was based on a two-sided alpha of 0.05.|log-binomial regression with GEE||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|The null hypothesis was that there would be no difference in oocyte maturity rate retrieved between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||1.05|0.90|0.47
70880783|NCT02310919|141246270|SUPERIORITY||Risk Ratio (RR)|0.88||||0.01|TWO_SIDED|95.0|0.76|0.97||The statistical significance was based on a two-sided alpha of 0.05.|log-binomial regression with GEE||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|||0.97|0.76|0.01
70960757|NCT00051363|141425942|SUPERIORITY_OR_OTHER|||||||0.8391||||||6M E/F Function- SAT-D-NumRuCh (Mild OSA); P\<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (\<=2 vs. \>=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.8391
70960758|NCT00051363|141425942|SUPERIORITY_OR_OTHER|||||||0.2771||||||6M E/F Function- SAT-D-NumRuCh (Moderate OSA); P\<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (\<=2 vs. \>=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.2771
70960759|NCT00051363|141425942|SUPERIORITY_OR_OTHER|||||||0.8961||||||6M E/F Function- SAT-D-NumRuCh (Severe OSA); P\<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (\<=2 vs. \>=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.8961
70960760|NCT00051363|141425943|SUPERIORITY_OR_OTHER|||||||0.654||||||DX- MWT-MSL; Comparison of means by visit only; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for DX Objective Sleepiness/Alertness- MWT-MSL.||||0.6540
70960761|NCT00051363|141425943|SUPERIORITY_OR_OTHER|||||||0.9778||||||DX- MWT-MSL (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for DX Objective Sleepiness/Alertness- MWT-MSL.||||0.9778
70960762|NCT00051363|141425943|SUPERIORITY_OR_OTHER|||||||0.8314||||||DX- MWT-MSL (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for DX Objective Sleepiness/Alertness- MWT-MSL.||||0.8314
70960763|NCT00051363|141425943|SUPERIORITY_OR_OTHER|||||||0.5018||||||DX- MWT-MSL (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for DX Objective Sleepiness/Alertness- MWT-MSL.||||0.5018
70960764|NCT00051363|141425943|SUPERIORITY_OR_OTHER|||||||0.0052||||||2M- MWT-MSL; Comparison of means by visit only; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 2M Objective Sleepiness/Alertness- MWT-MSL.||||0.0052
70960765|NCT00051363|141425943|SUPERIORITY_OR_OTHER|||||||0.2476||||||2M- MWT-MSL (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 2M Objective Sleepiness/Alertness- MWT-MSL.||||0.2476
70960766|NCT00051363|141425943|SUPERIORITY_OR_OTHER|||||||0.752||||||2M- MWT-MSL (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 2M Objective Sleepiness/Alertness- MWT-MSL.||||0.7520
70880784|NCT02310919|141246271|SUPERIORITY||Risk Ratio (RR)|1.0||||0.95|TWO_SIDED|95.0|0.9|1.1||The statistical significance was based on a two-sided alpha of 0.05.|log-binomial regression with GEE||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|The null hypothesis was that there would be no difference in ICSI fertilization rate retrieved between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||1.10|0.90|0.95
70960767|NCT00051363|141425943|SUPERIORITY_OR_OTHER|||||||0.0002||||||2M- MWT-MSL (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 2M Objective Sleepiness/Alertness- MWT-MSL.||||0.0002
70960768|NCT00051363|141425943|SUPERIORITY_OR_OTHER|||||||0.0022||||||6M- MWT-MSL; Comparison of means by visit only; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 6M Objective Sleepiness/Alertness- MWT-MSL.||||0.0022
70960769|NCT00051363|141425943|SUPERIORITY_OR_OTHER|||||||0.763||||||6M- MWT-MSL (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 6M Objective Sleepiness/Alertness- MWT-MSL.||||0.7630
70960770|NCT00051363|141425943|SUPERIORITY_OR_OTHER|||||||0.517||||||6M- MWT-MSL (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 6M Objective Sleepiness/Alertness- MWT-MSL.||||0.5170
70960771|NCT00051363|141425943|SUPERIORITY_OR_OTHER|||||||0.0002||||||6M- MWT-MSL (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 6M Objective Sleepiness/Alertness- MWT-MSL.||||0.0002
70960772|NCT00051363|141425944|SUPERIORITY_OR_OTHER|||||||0.9291||||||DX- ESS-TS; Comparison of means by visit only; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for DX Subjective Sleepiness/Alertness- ESS-TS.||||0.9291
70960773|NCT00051363|141425944|SUPERIORITY_OR_OTHER|||||||0.6152||||||DX- ESS-TS (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for DX Subjective Sleepiness/Alertness- ESS-TS.||||0.6152
70960774|NCT00051363|141425944|SUPERIORITY_OR_OTHER|||||||0.704||||||DX- ESS-TS (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for DX Subjective Sleepiness/Alertness- ESS-TS.||||0.7040
70960775|NCT00051363|141425944|SUPERIORITY_OR_OTHER|||||||0.9537||||||DX- ESS-TS (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for DX Subjective Sleepiness/Alertness- ESS-TS.||||0.9537
70960776|NCT00051363|141425944|SUPERIORITY_OR_OTHER|||||||0.0004||||||2M- ESS-TS; Comparison of means by visit only; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 2M Subjective Sleepiness/Alertness- ESS-TS.||||0.0004
70960777|NCT00051363|141425944|SUPERIORITY_OR_OTHER|||||||0.3886||||||2M- ESS-TS (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 2M Subjective Sleepiness/Alertness- ESS-TS.||||0.3886
70960778|NCT00051363|141425944|SUPERIORITY_OR_OTHER|||||||0.0236||||||2M- ESS-TS (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 2M Subjective Sleepiness/Alertness- ESS-TS.||||0.0236
70960779|NCT00051363|141425944|SUPERIORITY_OR_OTHER|||||||0.0005||||||2M- ESS-TS (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 2M Subjective Sleepiness/Alertness- ESS-TS.||||0.0005
70960780|NCT00051363|141425944|SUPERIORITY_OR_OTHER|||||||0.0005||||||6M- ESS-TS; Comparison of means by visit only; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 6M Subjective Sleepiness/Alertness- ESS-TS.||||0.0005
70960781|NCT00051363|141425944|SUPERIORITY_OR_OTHER|||||||0.3796||||||6M- ESS-TS (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 6M Subjective Sleepiness/Alertness- ESS-TS.||||0.3796
70960782|NCT00051363|141425944|SUPERIORITY_OR_OTHER|||||||0.0106||||||6M- ESS-TS (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 6M Subjective Sleepiness/Alertness- ESS-TS.||||0.0106
70960783|NCT00051363|141425944|SUPERIORITY_OR_OTHER|||||||0.001||||||6M- ESS-TS (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 6M Subjective Sleepiness/Alertness- ESS-TS.||||0.0010
70960784|NCT02678247|141425986|SUPERIORITY||Mean Difference (Final Values)|1.5|STANDARD_DEVIATION|1.5|<|0.001|TWO_SIDED|95.0|0.8|2.3||alpha = 0.05|t-test, 2 sided|paired t-test||||2.3|0.8|<0.001
70960785|NCT02678247|141425987|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.1||0.664|TWO_SIDED|95.0|-0.06|0.04||p-value was adjusted using a Bonferonni correction with alpha set at 0.017|t-test, 2 sided|paired t-test||||0.04|-0.06|0.664
70960786|NCT02678247|141425988|SUPERIORITY||Mean Difference (Final Values)|-1.7|STANDARD_DEVIATION|3.05||0.026|TWO_SIDED|95.0|-3.17|-0.23||p-value was adjusted using a Bonferonni correction with alpha set at 0.017|t-test, 2 sided|paired t-test||||-0.23|-3.17|0.026
70960787|NCT02678247|141425989|SUPERIORITY||Mean Difference (Final Values)|0.21|STANDARD_DEVIATION|4.58||0.847|TWO_SIDED|95.0|-2.0|2.42||p-value was adjusted using a Bonferonni correction with alpha set at 0.025|t-test, 2 sided|paired t-test||||2.42|-2|0.847
70960788|NCT02678247|141425990|SUPERIORITY||Mean Difference (Final Values)|-1.04|STANDARD_DEVIATION|2.87|<|0.017|TWO_SIDED|95.0|-2.42|0.34||p-value was adjusted using a Bonferonni correction with alpha set at 0.017|t-test, 2 sided|paired t-test||||0.34|-2.42|<0.017
70960789|NCT02678247|141425991|OTHER||Mean Difference (Final Values)|0.12|STANDARD_DEVIATION|4.58||0.7|TWO_SIDED|95.0|-0.53|0.77||p-value was adjusted using a Bonferonni correction with alpha set at 0.025|t-test, 2 sided|paired t-test||||0.77|-0.53|0.7
70960790|NCT02678247|141425992|SUPERIORITY||Mean Difference (Final Values)|2.7|STANDARD_DEVIATION|8.9||0.2|TWO_SIDED|95.0|-1.6|7.0||alpha = 0.05|t-test, 2 sided|paired t-test||||7.0|-1.6|0.20
70960791|NCT02678247|141425993|SUPERIORITY||Mean Difference (Final Values)|-1.2|STANDARD_DEVIATION|10.0||0.62|TWO_SIDED|95.0|-6.0|3.7||alpha = 0.05|t-test, 2 sided|paired t-test||||3.7|-6.0|0.62
70960792|NCT02678247|141425994|SUPERIORITY||Mean Difference (Final Values)|2.6|STANDARD_DEVIATION|5.7||0.07|TWO_SIDED|95.0|-0.2|5.3||alpha = 0.05|t-test, 2 sided|paired t-test||||5.3|-0.2|0.07
70960793|NCT02678247|141425995|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_DEVIATION|6.3||0.18|TWO_SIDED|95.0|-5.4|1.1||alpha = 0.05|t-test, 2 sided|paired t-test||||1.1|-5.4|0.18
70960794|NCT02678247|141425996|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|1.3||0.47|TWO_SIDED|95.0|-0.4|0.9||alpha = 0.05|t-test, 2 sided|paired t-test||||0.9|-0.4|0.47
70960795|NCT02678247|141425997|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|3.5||0.68|TWO_SIDED|95.0|-1.4|2.0||alpha = 0.05|t-test, 2 sided|paired t-test||||2.0|-1.4|0.68
70960796|NCT02092220|141426003|SUPERIORITY||Mean Difference (Final Values)|-20.28|STANDARD_DEVIATION|24.59|<|0.0001|TWO_SIDED|95.0|-28.0|-12.56||Repeated measures model.|t-test, 2 sided||Bionic Pancreas Arm - Usual Care Arm|||-12.56|-28.00|<0.0001
70960797|NCT02092220|141426004|SUPERIORITY||Mean Difference (Final Values)|1.3|||<|0.0001|TWO_SIDED|95.0|0.8|1.8||Repeated measures model.|t-test, 2 sided|||||1.8|0.8|<0.0001
70960798|NCT01231516|141426051|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority of DTG 50 mg and RAL at Week 48 can be concluded if the lower bound of a two-sided 95% confidence interval (CI) for the difference in percentages (DTG - RAL) is greater than -12%. If non-inferiority were established, superiority would be tested at the nominal 5% level based on a pre-specified testing procedure.|Difference in percentage|7.4||||0.03|TWO_SIDED|95.0|0.7|14.2||P-value is for test of superiority.|Cochran-Mantel-Haenszel|Adjusted difference in proportion which is based on the difference in percentage, adjusted for Baseline (BL) stratification factors.|Analysis was adjusted for BL stratification factors: HIV-1 RNA (\<=50000 versus \[vs\]\>50000 c/mL), darunavir-ritonavir use without primary protease inhibitor mutations (yes vs no), and phenotypic susceptibility score (2 vs \<2) to background regimen.|||14.2|0.7|0.030
70960799|NCT02146326|141426093|SUPERIORITY|||||||0.8|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.80
70960800|NCT02146326|141426094|SUPERIORITY|||||||0.8|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.80
70960801|NCT02146326|141426095|SUPERIORITY|||||||0.54|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.54
70960802|NCT02146326|141426096|SUPERIORITY|||||||0.94|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.94
70960803|NCT02146326|141426097|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.96
70960804|NCT02146326|141426098|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.17
70960805|NCT02146326|141426099|SUPERIORITY|||||||0.47|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.47
70960806|NCT02146326|141426100|SUPERIORITY|||||||0.6|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.60
70960807|NCT02146326|141426101|SUPERIORITY|||||||0.37|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.37
70960808|NCT02146326|141426102|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.83
70960809|NCT02146326|141426103|SUPERIORITY|||||||0.64|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.64
70960810|NCT02146326|141426104|SUPERIORITY|||||||0.37|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.37
70960811|NCT02146326|141426105|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.13
70960812|NCT02146326|141426106|SUPERIORITY|||||||0.93|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.93
70960813|NCT02146326|141426107|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.11
70960814|NCT02146326|141426108|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.21
70960815|NCT02146326|141426110|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.17
70960816|NCT02146326|141426111|SUPERIORITY|||||||0.24|||||||Mixed Models Analysis|||||||0.24
70960817|NCT02146326|141426112|SUPERIORITY|||||||0.35|||||||Chi-squared|||||||0.35
70960818|NCT02146326|141426113|SUPERIORITY|||||||0.67|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.67
70960819|NCT02146326|141426114|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.04
70960820|NCT02146326|141426115|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.34
70960821|NCT02146326|141426116|SUPERIORITY|||||||0.71|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.71
70960822|NCT02146326|141426117|SUPERIORITY|||||||0.22|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.22
70960823|NCT02146326|141426118|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.11
70960824|NCT02146326|141426119|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.14
70960825|NCT02146326|141426120|SUPERIORITY|||||||0.55|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.55
70960826|NCT02146326|141426121|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.91
70960827|NCT02146326|141426122|SUPERIORITY|||||||0.48|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.48
70960828|NCT02146326|141426123|SUPERIORITY|||||||0.67|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.67
70960829|NCT02146326|141426124|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.77
70880785|NCT02310919|141246272|SUPERIORITY||Risk Ratio (RR)|0.95||||0.52|TWO_SIDED|95.0|0.81|1.12||The statistical significance was based on a two-sided alpha of 0.05.|log-binomial regression with GEE||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|The null hypothesis was that there would be no difference in the percentage of high quality cleavage-stage embryos between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||1.12|0.81|0.52
70960830|NCT02146326|141426125|SUPERIORITY|||||||0.59|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.59
70960831|NCT02146326|141426126|SUPERIORITY|||||||0.64|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.64
70960832|NCT02146326|141426127|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.05
70960833|NCT02146326|141426128|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.06
70960834|NCT02146326|141426129|SUPERIORITY|||||||0.84|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.84
70960835|NCT02146326|141426130|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.14
70960836|NCT02146326|141426131|SUPERIORITY|||||||0.45|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.45
70960837|NCT02910739|141426132|OTHER|The pharmacokinetic condition to initiate Part 2 of the study would be met if the point estimate for the AUC0-∞ ratio of geometric means (participants with moderate HI / healthy matched control participants) exceeds 1.5.|Geometric least-squares mean ratio (GMR)|1.04|||||TWO_SIDED|90.0|0.83|1.3|||||GMR = geometric least squares mean (GLSM) for moderate HI participants / GLSM for healthy participants.|Per study protocol, the purpose of this analysis is only to estimate the effect of moderate HI on AUC0-∞; no hypothesis testing was planned for this outcome measure.||1.30|0.83|
70960838|NCT02910739|141426133|OTHER||GMR|1.07|||||TWO_SIDED|90.0|0.77|1.5|||||GMR = GLSM for moderate HI participants / GLSM for healthy participants.|Per study protocol, the purpose of this analysis is only to estimate the effect of moderate HI on Cmax; no hypothesis testing was planned for this outcome measure.||1.50|0.77|
70960839|NCT02910739|141426134|OTHER||GMR|1.04|||||TWO_SIDED|90.0|0.82|1.31|||||GMR = GLSM for moderate HI participants / GLSM for healthy participants.|Per study protocol, the purpose of this analysis is only to estimate the effect of moderate HI on AUC0-last; no hypothesis testing was planned for this outcome measure.||1.31|0.82|
70960840|NCT02910739|141426135|OTHER||GMR|1.01|||||TWO_SIDED|90.0|0.8|1.27|||||GMR = GLSM for moderate HI participants / GLSM for healthy participants.|Per study protocol, the purpose of this analysis is only to estimate the effect of moderate HI on AUC0-24hr; no hypothesis testing was planned for this outcome measure.||1.27|0.80|
70960841|NCT02910739|141426136|OTHER||GMR|1.08|||||TWO_SIDED|90.0|0.9|1.3|||||GMR = GLSM for moderate HI participants / GLSM for healthy participants.|Per study protocol, the purpose of this analysis is only to estimate the effect of moderate HI on C24hr; no hypothesis testing was planned for this outcome measure.||1.30|0.90|
70960842|NCT02181387|141426153|OTHER|unpaired t-test compared between groups|||||>|0.05|||||||unpaired t-test compared between groups|||||||>0.05
70960843|NCT02181387|141426153|OTHER|unpaired t-test compared between groups|||||>|0.05|||||||unpaired t-test compared between groups|||||||>0.05
70960844|NCT00081770|141426251|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.567||95.0|0.79|1.14||Holm's method for multiplicity adjustment was to be used to control the overall Type I error rate at α = 0.05. However, since there was no significant difference in the overall SVR rates between the three groups, no Type-1 error adjustment was made.|Regression, Logistic|The p-value is based on the logistic regression model that includes treatment and baseline stratification factors (viral load and race).|The odds ratio is based on the logistic regression model that includes treatment and baseline stratification factors: viral load (≤600,000 IU/mL vs \>600,000 IU/mL) and race (Black vs non-Black).|||1.14|0.79|0.567
70960845|NCT00081770|141426251|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.195||95.0|0.9|1.3||Holm's method for multiplicity adjustment was to be used to control the overall Type I error rate at α = 0.05. However, since there was no significant difference in the overall SVR rates between the three groups, no Type-1 error adjustment was made.|Regression, Logistic|The p-value is based on the logistic regression model that includes treatment and baseline stratification factors (viral load and race).|The odds ratio is based on the logistic regression model that includes treatment and baseline stratification factors: viral load (≤600,000 IU/mL vs \>600,000 IU/mL) and race (Black vs non-Black).|||1.30|0.90|0.195
70960846|NCT00081770|141426253|SUPERIORITY_OR_OTHER||Percentage of participants|39.9||||||95.0|36.9|42.9|||||Percentage of participants with undetectable HCV-RNA at Treatment Week 12|||42.9|36.9|
70960847|NCT00081770|141426253|SUPERIORITY_OR_OTHER||Percentage of participants|36.0||||||95.0|33.1|39.0|||||Percentage of participants with undetectable HCV-RNA at Treatment Week 12|||39.0|33.1|
70960848|NCT00081770|141426253|SUPERIORITY_OR_OTHER||Percentage of participants|45.0||||||95.0|42.0|48.1|||||Percentage of participants with undetectable HCV-RNA at Treatment Week 12|||48.1|42.0|
70960849|NCT00601419|141426257|SUPERIORITY_OR_OTHER||||||=|0.556|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is that there is no difference between \<65 years and \>=65 years in the frequency of treatment related adverse events."||||=0.556
70960850|NCT00601419|141426258|SUPERIORITY_OR_OTHER||||||=|0.845|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is that there is no difference between Male and Female in the frequency of treatment related adverse events."||||=0.845
70960851|NCT00601419|141426259|SUPERIORITY_OR_OTHER||||||=|0.038|TWO_SIDED||||||Fisher Exact|||"The null hypothesis is that there is no difference between With TSH deficiency and Without TSH deficiency in the frequency of treatment related adverse events."||||=0.038
70960852|NCT00601419|141426260|SUPERIORITY_OR_OTHER||||||=|0.013|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Past history. The null hypothesis is that there is no difference between With past history and Without past history in the frequency of treatment related adverse events."||||=0.013
70960853|NCT00601419|141426261|SUPERIORITY_OR_OTHER||||||=|0.037|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Initial Dose. The null hypothesis is that there is no association between Initial Dose and the frequency of treatment related adverse events."||||=0.037
70960854|NCT00601419|141426261|SUPERIORITY_OR_OTHER||||||=|0.063|TWO_SIDED||||||Cochran-Armitage Exact|||"The risk factor tested was Initial Dose. The null hypothesis is that there is no linear trend in the frequency of treatment related adverse events across increasing levels of initial dose."||||=0.063
70960855|NCT00601419|141426263|SUPERIORITY_OR_OTHER||||||=|0.019|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is that there is no difference between \<65 years of age and \>=65 years of age in the efficacy of somatropin."||||=0.019
70960856|NCT00601419|141426264|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is that there is no difference between male and female in the efficacy of somatropin."||||=1.000
70960857|NCT00601419|141426265|SUPERIORITY_OR_OTHER||||||=|0.037|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was ACTH deficiency. The null hypothesis is that there is no difference between With ACTH deficiency and Without ACTH deficiency in the efficacy of somatropin."||||=0.037
70960858|NCT02245672|141426269|SUPERIORITY|In order for the bioequivalence results to be valid, assay sensitivity had to be established. For assay sensitivity, the following comparisons were performed using the Full Analysis Set for each co-primary endpoint: MGR001 versus placebo, and Advair Diskus versus placebo. Assay sensitivity was demonstrated if the p-values for active treatment versus placebo were less than 0.05|||||<|0.0001|||||||ANCOVA|||MGR001 (Test) vs Placebo||||<0.0001
70960859|NCT02245672|141426269|SUPERIORITY|In order for the bioequivalence results to be valid, assay sensitivity had to be established.For assay sensitivity, the following comparisons were performed using the Full Analysis Set for each co-primary endpoint: MGR001 versus placebo, and Advair Diskus versus placebo. Assay sensitivity was demonstrated if the p-values for active treatment versus placebo were less than 0.05|||||<|0.0001|||||||ANCOVA|||Advair Diskus (Reference) vs Placebo||||<0.0001
70960860|NCT02245672|141426270|EQUIVALENCE|A linear analysis of covariance (ANCOVA) model was fitted for the endpoint and least-squares (LS) means were derived for each treatment. To assess equivalence, LS means (one for Test and one for Reference) from the ANCOVA models were used to generate Test/Reference ratios and 90% CIs were calculated by using Fieller's theorem. To demonstrate equivalence, the 90% CIs were each required to be wholly contained within the interval 0.80-1.25 (i.e., 80%-125%).|Ratio (MGR001/Advair Diskus)|1.12|||||TWO_SIDED|90.0|1.016|1.237|||||Bioequivalence was established between active treatments (MGR001 and Advair Diskus) for the FEV1 AUEC0-12 clinical endpoint|Equivalence of MGR001 and Advair Diskus is established if the ratio of the LS means and 90% confidence interval are wholly contained within the interval 0.80-1.25 (i.e., 80%-125%).||1.237|1.016|
70960861|NCT02245672|141426271|SUPERIORITY|In order for the bioequivalence results to be valid, assay sensitivity had to be established. For assay sensitivity, the following comparisons were performed using the Full Analysis Set for each co-primary endpoint: MGR001 versus placebo, and Advair Diskus versus placebo. Assay sensitivity was demonstrated if the p-values for active treatment versus placebo were less than 0.05|||||<|0.0001|||||||ANCOVA|||MGR001 (Test) vs Placebo||||<0.0001
70960862|NCT02245672|141426271|SUPERIORITY|In order for the bioequivalence results to be valid, assay sensitivity had to be established. For assay sensitivity, the following comparisons were performed using the Full Analysis Set for each co-primary endpoint: MGR001 versus placebo, and Advair Diskus versus placebo. Assay sensitivity was demonstrated if the p-values for active treatment versus placebo were less than 0.05|||||<|0.0001|||||||ANCOVA|||Advair Diskus (Reference) vs Placebo||||<0.0001
70960863|NCT02245672|141426272|EQUIVALENCE|A linear analysis of covariance (ANCOVA) model was fitted for the endpoint and least-squares (LS) means were derived for each treatment. To assess equivalence, LS means (one for Test and one for Reference) from the ANCOVA models were used to generate Test/Reference ratios and 90% CIs were calculated by using Fieller's theorem. To demonstrate equivalence, the 90% CIs were each required to be wholly contained within the interval 0.80-1.25 (i.e., 80%-125%).|Ratio (MGR001/Advair Diskus)|1.069|||||TWO_SIDED|90.0|0.938|1.22|||||Bioequivalence was established between active treatments (MGR001 and Advair Diskus) for change from baseline in trough FEV1 endpoint on Day 29|Equivalence of MGR001 and Advair Diskus is established if the ratio of the LS means and 90% confidence interval are wholly contained within the interval 0.80-1.25 (i.e., 80%-125%).||1.220|0.938|
70960864|NCT01097785|141426280|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Student's t-test|||||||<0.05
70960865|NCT01097785|141426281|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Student's t-test|||||||<0.05
70960866|NCT01765192|141426282|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.039||0.013|TWO_SIDED|95.0|0.0219|0.1795|||ANCOVA|||The primary endpoint was analyzed using an analysis of covariance model adapted for the crossover design. The following fixed factors and covariates were included in the model: Treatment, sequence, period, and baseline FEV1 measurement of the respective treatment period. The reported analysis results are for the 2 crossover treatment periods combined.||0.1795|0.0219|0.013
70960867|NCT01765192|141426283|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.04||0.129|TWO_SIDED|95.0|-0.0185|0.1422||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline pre-bronchodilator FVC measurement as the covariate.|ANCOVA|||||0.1422|-0.0185|0.129
70960868|NCT01765192|141426284|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.056||0.032|TWO_SIDED|95.0|0.0113|0.2364||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline pre-bronchodilator FEF measurement as the covariate.|ANCOVA|||||0.2364|0.0113|0.032
70960869|NCT01765192|141426285|SUPERIORITY_OR_OTHER||LS Mean Difference|7.21|STANDARD_ERROR_OF_MEAN|15.105||0.635||95.0|-23.0531|37.466||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline pre-bronchodilator PEF measurement as the covariate.|ANCOVA|||||37.4660|-23.0531|0.635
70960870|NCT01765192|141426286|SUPERIORITY_OR_OTHER||LS Mean Difference|13.62|STANDARD_ERROR_OF_MEAN|5.206||0.011|TWO_SIDED|95.0|3.1896|24.0553||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline pre-bronchodilator PEF measurement as the covariate.|ANCOVA|||||24.0553|3.1896|0.011
70960871|NCT01765192|141426287|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.089||0.025|TWO_SIDED|95.0|-0.385|-0.0271||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline Daytime Asthma Symptom Score as the covariate.|ANCOVA|||||-0.0271|-0.3850|0.025
70960872|NCT01765192|141426288|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.075||0.217|TWO_SIDED|95.0|-0.2426|0.0563||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline Nighttime Asthma Symptoms measurement as the covariate.|ANCOVA|||||0.0563|-0.2426|0.217
70960873|NCT01535014|141426300|SUPERIORITY|||||||0.04|||||||Chi-squared|||||||0.04
70960874|NCT01535014|141426300|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
70960875|NCT01535014|141426300|SUPERIORITY|||||||0.0007|||||||Cochran-Mantel-Haenszel|||||||0.0007
70960876|NCT01535014|141426301|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
70960877|NCT01535014|141426301|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
70960878|NCT01535014|141426302|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
70960879|NCT01535014|141426302|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
70960880|NCT01535014|141426303|SUPERIORITY||||||<|0.05||||||For week 12, 16, 20, 24|Chi-squared|||||||<0.05
70960881|NCT01535014|141426303|SUPERIORITY||||||<|0.05||||||For week 16, 20, 24|Chi-squared|||||||<0.05
70960882|NCT01535014|141426304|SUPERIORITY|||||||0.019|||||||ANCOVA|||||||0.019
70960883|NCT01535014|141426304|SUPERIORITY|||||||0.043|||||||ANCOVA|||||||0.043
70960884|NCT01535014|141426305|SUPERIORITY|||||||0.2|||||||ANCOVA|||||||0.20
70960885|NCT01535014|141426305|SUPERIORITY|||||||0.75|||||||ANCOVA|||||||0.75
70960886|NCT01535014|141426306|SUPERIORITY|||||||0.02|||||||ANCOVA|||SF-36 Mental Health Domain||||0.02
70960887|NCT01535014|141426306|SUPERIORITY|||||||0.63|||||||ANCOVA|||SF-36 Mental Health Domain||||0.63
70960888|NCT01535014|141426306|SUPERIORITY|||||||0.6|||||||ANCOVA|||SF-36 Physical Health Domain||||0.60
70960889|NCT01535014|141426306|SUPERIORITY|||||||0.98|||||||ANCOVA|||SF-36 Physical Health Domain||||0.98
70960890|NCT01215422|141426307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0|||>|0.05|ONE_SIDED|95.0|0.15||||Regression, Logistic||||||0.15|>0.05
70960891|NCT01215422|141426308|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||The p-value represents the comparison of the two interventions combined and compared against baseline for Grades III and IV summed together.|Fisher Exact|||||||0.03
70960892|NCT01215422|141426311|SUPERIORITY_OR_OTHER||R-squared|0.16|||>|0.05||95.0||||Correlation between years of experience (all anesthesiologists, pooled) and time to intubation (both GS and KS VLSs, pooled)|Correlation|||||||>0.05
70960893|NCT02864381|141426319|SUPERIORITY||Odds Ratio (OR)|1.5||||0.8|TWO_SIDED|95.0|0.4|6.1||P-value is derived from Cochran-Mantel Haenszel (CMH) test stratified by programmed death ligand 1 (PD-L1) stratification factor status.|Cochran-Mantel-Haenszel||Odds Ratio is derived from CMH test stratified by PD-L1 stratification factor status, the Nivolumab alone arm serves as the reference.|||6.1|0.4|0.8
70960894|NCT02864381|141426320|SUPERIORITY||Hazard Ratio (HR)|0.836||||0.306|TWO_SIDED|95.0|0.589|1.189||P-value is derived from log-rank test stratified by PD-L1 stratification factor status.|Log Rank||Hazard ratio is derived from Cox model stratified by PD-L1 stratification factor status, the Nivolumab alone arm serves as the reference.|||1.189|0.589|0.306
70960895|NCT02864381|141426321|SUPERIORITY||Hazard Ratio (HR)|0.786||||0.312|TWO_SIDED|95.0|0.491|1.257||P-value is derived from log-rank test stratified by PD-L1 stratification factor status.|Log Rank||Hazard ratio is derived from Cox model stratified by PD-L1 stratification factor status, the Nivolumab alone arm serves as the reference.|||1.257|0.491|0.312
70960896|NCT02113241|141426472|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||<0.001
70960897|NCT02113241|141426472|SUPERIORITY|||||||0.089||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.089
70960898|NCT02113241|141426473|SUPERIORITY|||||||0.003||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.003
70960899|NCT02113241|141426473|SUPERIORITY|||||||0.248||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.248
70960900|NCT02113241|141426474|SUPERIORITY|||||||0.161||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.161
70960901|NCT02113241|141426474|SUPERIORITY|||||||0.079||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.079
70960902|NCT02113241|141426475|SUPERIORITY|||||||0.067||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.067
70960903|NCT02113241|141426475|SUPERIORITY|||||||0.918||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.918
70960904|NCT02113241|141426476|SUPERIORITY|||||||0.128||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.128
70960905|NCT02113241|141426476|SUPERIORITY|||||||0.454||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.454
70960906|NCT02113241|141426477|SUPERIORITY|||||||0.433|||||||Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.433
70960907|NCT02113241|141426477|SUPERIORITY|||||||0.407||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.407
70960908|NCT02113241|141426478|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||<0.001
70960909|NCT02113241|141426478|SUPERIORITY|||||||0.826||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.826
70960910|NCT02113241|141426479|SUPERIORITY|||||||0.791||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.791
70960911|NCT02113241|141426479|SUPERIORITY|||||||0.413||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.413
70960912|NCT02113241|141426480|SUPERIORITY|||||||0.075||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.075
70960913|NCT02113241|141426480|SUPERIORITY|||||||0.432||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.432
70960914|NCT02113241|141426481|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||<0.001
70960915|NCT02113241|141426481|SUPERIORITY|||||||0.835||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.835
70960916|NCT02113241|141426482|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||<0.001
70960917|NCT02113241|141426482|SUPERIORITY|||||||0.778||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.778
70960918|NCT02113241|141426483|SUPERIORITY|||||||0.338||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.338
70960919|NCT02113241|141426483|SUPERIORITY|||||||0.309||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.309
70960920|NCT02113241|141426484|SUPERIORITY|||||||0.049||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.049
70960921|NCT02113241|141426484|SUPERIORITY|||||||0.563||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.563
70960922|NCT02113241|141426485|SUPERIORITY|||||||0.85||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.850
70960923|NCT02113241|141426485|SUPERIORITY|||||||0.206||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.206
70960924|NCT02113241|141426486|SUPERIORITY|||||||0.006||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.006
70960925|NCT02113241|141426486|SUPERIORITY|||||||0.95||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.950
70960926|NCT02113241|141426487|SUPERIORITY|||||||0.011||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.011
70960927|NCT02113241|141426487|SUPERIORITY|||||||0.454||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.454
70960928|NCT02113241|141426488|SUPERIORITY|||||||0.652||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.652
70960929|NCT02113241|141426488|SUPERIORITY|||||||0.055||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.055
70960930|NCT02113241|141426489|SUPERIORITY|||||||0.254||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.254
70960931|NCT02113241|141426489|SUPERIORITY|||||||0.787||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.787
70960932|NCT02113241|141426490|SUPERIORITY|||||||0.129||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.129
70960933|NCT02113241|141426490|SUPERIORITY|||||||0.365||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.365
70960934|NCT02113241|141426491|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||<0.001
70960935|NCT02113241|141426491|SUPERIORITY|||||||0.175||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.175
70960936|NCT02113241|141426492|SUPERIORITY|||||||0.392||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.392
70960937|NCT02113241|141426492|SUPERIORITY|||||||0.123|||||||Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.123
70960938|NCT02113241|141426493|SUPERIORITY|||||||0.176||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.176
70960939|NCT02113241|141426493|SUPERIORITY|||||||0.268||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.268
70960940|NCT02113241|141426494|SUPERIORITY|||||||0.064||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.064
70960941|NCT02113241|141426494|SUPERIORITY|||||||0.462||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.462
70960942|NCT02113241|141426495|SUPERIORITY|||||||0.346||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.346
70960943|NCT02113241|141426495|SUPERIORITY|||||||0.002||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.002
70960944|NCT02901041|141426497|SUPERIORITY||Mean Difference (Net)|0.02||||0.98|TWO_SIDED|95.0|-1.41|1.45|||t-test, 2 sided|t=0.03, df=79.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||1.45|-1.41|.98
70960945|NCT02901041|141426498|SUPERIORITY||Mean Difference (Net)|-0.83||||0.13|TWO_SIDED|95.0|-1.92|0.26|||t-test, 2 sided|t=-1.52, df=56.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||0.26|-1.92|.13
70960946|NCT02901041|141426499|SUPERIORITY||Mean Difference (Net)|-0.07||||0.19|TWO_SIDED|95.0|-0.17|0.03||Equality of variance was not assumed.|t-test, 2 sided|t=-1.33, df=72.65||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||0.03|-0.17|.19
70960947|NCT02901041|141426500|SUPERIORITY||Mean Difference (Net)|-0.17||||0.05|TWO_SIDED|95.0|-0.34|0.0|||t-test, 2 sided|t=-1.99, df=56.00||||0.00|-0.34|.05
70960948|NCT02901041|141426501|SUPERIORITY||Mean Difference (Net)|0.03||||0.71|TWO_SIDED|95.0|-0.11|0.17|||t-test, 2 sided|t=0.37,df=79.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||0.17|-0.11|.71
70960949|NCT02901041|141426502|SUPERIORITY||Mean Difference (Net)|-0.11||||0.12|TWO_SIDED|95.0|-0.26|0.03|||t-test, 2 sided|t=-1.59,df=56.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||0.03|-0.26|.12
70960950|NCT02901041|141426503|SUPERIORITY||Mean Difference (Net)|0.14||||0.98|TWO_SIDED|95.0|-9.89|10.18|||t-test, 2 sided|t=0.03, df=79.00||||10.18|-9.89|.98
70960951|NCT02901041|141426504|SUPERIORITY||Mean Difference (Net)|-5.8||||0.13|TWO_SIDED|95.0|-13.43|1.83|||t-test, 2 sided|t=-1.52, df=56.00||||1.83|-13.43|.13
70960952|NCT02901041|141426505|SUPERIORITY||Mean Difference (Net)|27.07||||0.75|TWO_SIDED|95.0|-144.06|198.2|||t-test, 2 sided|t=0.32,df=61.00||||198.20|-144.06|.75
70960953|NCT02901041|141426506|SUPERIORITY||Mean Difference (Net)|99.05||||0.35|TWO_SIDED|95.0|-111.11|309.21|||t-test, 2 sided|t=0.95, df=46.00||||309.21|-111.11|.35
70880786|NCT02310919|141246273|SUPERIORITY||Risk Ratio (RR)|0.99||||0.87|TWO_SIDED|95.0|0.84|1.16||The statistical significance was based on a two-sided alpha of 0.05.|log-binomial regression with GEE||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|||1.16|0.84|0.87
70960954|NCT02901041|141426507|SUPERIORITY||Mean Difference (Net)|0.85||||0.51|TWO_SIDED|95.0|-1.69|3.4|||t-test, 2 sided|t=0.67, df=58.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||3.40|-1.69|.51
70880787|NCT02310919|141246274|SUPERIORITY||Risk Ratio (RR)|1.01||||1|TWO_SIDED|95.0|0.59|1.74||The statistical significance was based on a two-sided alpha of 0.05.|Fisher Exact||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|The null hypothesis was that there would be no difference in livebirths in fresh transfers between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||1.74|0.59|1.0
70880788|NCT02310919|141246275|SUPERIORITY|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that there would be no difference in the change in bloating scores from day of baseline ultrasound to post-trigger day 5 between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||||0.98
70880789|NCT02310919|141246276|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that there would be no difference in the change in abdominal circumference from day of baseline ultrasound to post-trigger day 5 between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||||0.39
70880790|NCT02310919|141246277|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that there would be no difference in the change in body weight from day of baseline ultrasound to post-trigger day 5 between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||||0.41
70880791|NCT02310919|141246278|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
70880792|NCT02310919|141246279|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
70880793|NCT02310919|141246280|SUPERIORITY|||||||0.08||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.08
70880794|NCT02310919|141246281|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
70880795|NCT02310919|141246282|SUPERIORITY|||||||0.67||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.67
70880796|NCT02310919|141246283|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
70880797|NCT02310919|141246284|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
70880798|NCT02310919|141246285|SUPERIORITY|||||||0.49||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.49
70880799|NCT02310919|141246286|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
70880800|NCT02310919|141246287|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
70880801|NCT02310919|141246288|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
70880802|NCT02310919|141246289|SUPERIORITY|||||||0.16||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.16
70880803|NCT02310919|141246290|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
70880804|NCT02310919|141246291|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
70880805|NCT02310919|141246292|SUPERIORITY|||||||0.95||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.95
70880806|NCT02310919|141246293|SUPERIORITY|||||||0.07||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.07
70880807|NCT02310919|141246294|SUPERIORITY|||||||0.66||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.66
70880808|NCT00697515|141246295|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
70880809|NCT00697515|141246296|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017||95.0|||||ANOVA|||2.0 hours post-dose||||0.0017
70880810|NCT00697515|141246296|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||4.0 hours post-dose||||<0.0001
70880811|NCT00697515|141246296|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||8.0 hours post-dose||||<0.0001
70880812|NCT00697515|141246296|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||10.0 hours post-dose||||<0.0001
70880813|NCT00697515|141246296|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||12.0 hours post-dose||||<0.0001
70880814|NCT00697515|141246296|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||14.0 hours post-dose||||<0.0001
70880815|NCT00697515|141246297|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||Average over the treatment day||||<0.0001
70880816|NCT00697515|141246297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||ANOVA|||2.0 hours post-dose||||0.0010
70880817|NCT00697515|141246297|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||4.0 hours post-dose||||<0.0001
70880818|NCT00697515|141246297|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||8.0 hours post-dose||||<0.0001
70880819|NCT00697515|141246297|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||10.0 hours post-dose||||<0.0001
70880820|NCT00697515|141246297|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||12.0 hours post-dose||||<0.0001
70880821|NCT00697515|141246297|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||14.0 hours post-dose||||<0.0001
70880822|NCT00697515|141246298|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||Over the treatment day||||<0.0001
70880823|NCT00697515|141246298|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0031||95.0|||||ANOVA|||2.0 hours post-dose||||0.0031
70880824|NCT00697515|141246298|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||4.0 hours post-dose||||<0.0001
70880825|NCT00697515|141246298|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||8.0 hours post-dose||||<0.0001
70880826|NCT00697515|141246298|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||10.0 hours post-dose||||<0.0001
70960955|NCT02901041|141426508|SUPERIORITY||Mean Difference (Net)|-0.42||||0.55|TWO_SIDED|95.0|-1.82|0.98|||t-test, 2 sided|t=-0.61,df=36||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||0.98|-1.82|.55
70880827|NCT00697515|141246298|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||12.0 hours post-dose||||<0.0001
70880828|NCT00697515|141246298|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||14.0 hours post-dose||||<0.0001
70880829|NCT00697515|141246299|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
70880830|NCT00697515|141246300|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
70880831|NCT00697515|141246303|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Prescott's Test|||||||<0.0001
70880832|NCT00697515|141246304|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
70880833|NCT00697515|141246306|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
70880834|NCT00697515|141246307|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
70880835|NCT02603432|141246312|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0005|TWO_SIDED|95.0|0.556|0.863||One-sided log-rank test was used.|Log Rank|Analysis was performed using a Cox's Proportional Hazard model.||||0.863|0.556|0.0005
70880836|NCT02603432|141246335|SUPERIORITY||Cox Proportional Hazard|1.26||||0.913|ONE_SIDED|95.0|0.901||||Log Rank||||||0.901|0.9130
70880837|NCT05954052|141246339|SUPERIORITY||Mean Difference (Final Values)|4.0|STANDARD_DEVIATION|9.0||0.1807|TWO_SIDED|95.0|-6.24|14.24|||Wilcoxon (Mann-Whitney)|||For the analysis of (ABC) scores at baseline and 12 weeks in this single-arm, open-label pilot study (n=6 participants, all with paired data including the early dropout), we use superiority test, This aligns with the study's hypothesis that oral glutathione supplementation would lead to an improvement (i.e., a decrease in ABC scores, indicating reduced irritability). Superiority testing evaluates whether the post-treatment mean (or median) is significantly lower than the baseline||14.24|-6.24|0.1807
70880838|NCT01856790|141246345|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Wilcoxon Matched Pairs signed rank tests|||||||0.05
70880839|NCT01856790|141246346|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon Matched Pairs signed rank tests|||||||0.002
70880840|NCT01856790|141246348|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97|||||||Wilcoxon Matched Pairs signed rank tests|||||||0.97
70880841|NCT01856790|141246352|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon Matched Pairs signed rank tests|||||||.001
70880842|NCT01856790|141246353|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Wilcoxon Matched Pairs signed rank tests|||||||0.005
70880843|NCT01124604|141246355|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.46||||95.0|-1.04|0.8|||||Test for no difference between treatments was derived from Analysis of covariance (ANCOVA) model with factors treatment, disease and Baseline pain intensity as covariate.|||0.80|-1.04|
70880844|NCT02596854|141246377|NON_INFERIORITY|α=0.025 with a margin of Δ=0.5 were used for non-inferiority testing|Median Difference (Net)|-0.428|STANDARD_ERROR_OF_MEAN|0.3522|<|0.001|TWO_SIDED|95.0|-0.428|-0.269||No adjustments were made for multiple comparisons.|Wilcoxon (Mann-Whitney)||Notably, no separate comparative statistical analysis was performed for the 1.5T and 3.0T subgroups, which were pooled for analysis. All patients underwent both synthetic MR and commercial conventional MR in a single arm.|Non-inferiority of synthetic MR versus conventional commercial MR the hypothesis can be stated as H0: S ≤ -Δ and HA: S \> -Δ.|To mitigate possible bias, the hypothesis test was executed via pre-programmed SAS module, which does not show the data for individual synthetic and conventional group values. The data for these individual groups is thus not currently available as part of the study report held by the sponsor or submitted to FDA. Thus, this data cannot be presented without additional analysis (re-programming) of the original SAS used to perform the study. Data were only reported as the difference between synthetic - conventional to determine non-inferiority, and data for individual crossovers (synthetic vs. conventional) were not calculated.The raw conventional scan images and those post-processed with the research software were combined as pre-specified in the study protocol|-0.269|-0.428|<0.001
70880845|NCT02864251|141246418|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0528|TWO_SIDED|95.0|0.56|1.0||Log-rank test stratified by PD-L1 expression (\>= 1% vs \<1%/indeterminate/not evaluable), brain metastases (presence vs absence), smoking history (current/former vs never smoker), and prior osimertinib use (yes vs no) from IRT.|Log Rank||Arm A over Arm C Stratified Cox proportional hazard model.|||1.00|0.56|0.0528
70880846|NCT02864251|141246418|SUPERIORITY||Hazard Ratio (HR)|2.07|||||TWO_SIDED|95.0|1.43|2.99|||||Arm B over Arm C Stratified Cox proportional hazard model.|||2.99|1.43|
70880847|NCT02864251|141246419|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.218|TWO_SIDED|95.0|0.62|1.12|||Log Rank||Hazard Ratio (Arm A over Arm C) is based on a stratified Cox proportional hazard model|||1.12|0.62|0.2180
70880848|NCT02864251|141246419|SUPERIORITY||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.75|1.52|||||Hazard Ratio (Arm B over Arm C) is based on a stratified Cox proportional hazard model.|||1.52|0.75|
70880849|NCT02864251|141246420|SUPERIORITY||Odds Ratio (OR)|1.27|||||TWO_SIDED|95.0|0.75|2.16|||||Strata adjusted odds ratio (Arm A over Arm C) using Mantel-Haenszel method.|||2.16|0.75|
70880850|NCT02438722|141246446|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.44|TWO_SIDED|95.0|0.5|1.36|||Log Rank|||||1.36|0.50|0.44
70880851|NCT02438722|141246447|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.94|TWO_SIDED|95.0|0.72|1.43|||Log Rank|||||1.43|0.72|0.94
70880852|NCT02438722|141246449|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.54|TWO_SIDED|95.0|0.64|1.26|||Log Rank|||||1.26|0.64|0.54
70960956|NCT02901041|141426509|SUPERIORITY||Mean Difference (Net)|0.15||||0.95|TWO_SIDED|95.0|-4.15|4.45|||t-test, 2 sided|t=0.07,df=58.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||4.45|-4.15|.95
70960957|NCT02901041|141426510|SUPERIORITY||Mean Difference (Net)|3.34||||0.42|TWO_SIDED|95.0|-4.93|11.62|||t-test, 2 sided|t=0.82, df=38.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||11.62|-4.93|.42
70960958|NCT02901041|141426511|SUPERIORITY||Mean Difference (Net)|0.32||||0.17|TWO_SIDED|95.0|-0.15|0.8||Equal variance was not assumed.|t-test, 2 sided|t=1.39, df=36.37||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||0.80|-0.15|.17
70960959|NCT02901041|141426512|SUPERIORITY||Mean Difference (Net)|0.41||||0.14|TWO_SIDED|95.0|-0.14|0.97||Equal variances were not assumed when conducting the t-test.|t-test, 2 sided|t=1.53, df=24.05||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||0.97|-0.14|0.14
70960960|NCT02901041|141426513|SUPERIORITY||Mean Difference (Net)|3.07||||0.14|TWO_SIDED|95.0|-1.03|7.16||Equal variances were not assumed when conducting the t-tests.|t-test, 2 sided|t=1.51,df=39.34||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||7.16|-1.03|.14
70960961|NCT02901041|141426514|SUPERIORITY||Mean Difference (Net)|3.18||||0.4|TWO_SIDED|95.0|-4.39|10.75||Equality of variance was not assumed.|t-test, 2 sided|t=0.85, df=39.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||10.75|-4.39|.40
70960962|NCT02901041|141426515|SUPERIORITY||Mean Difference (Net)|0.4||||0.06|TWO_SIDED|95.0|-0.01|0.81||Equal variances were not assumed when conducting the t-test.|t-test, 2 sided|t=1.97, df=38.37||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||0.81|-0.01|.06
70960963|NCT02901041|141426516|SUPERIORITY||Mean Difference (Net)|0.03||||0.96|TWO_SIDED|95.0|-1.0|1.05|||t-test, 2 sided|t=.06, df=39.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||1.05|-1.00|.96
70960964|NCT02901041|141426517|SUPERIORITY||Mean Difference (Net)|2.03||||0.6|TWO_SIDED|95.0|-5.58|9.64|||t-test, 2 sided|t=0.53,df=57.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||9.64|-5.58|.60
70960965|NCT02901041|141426518|SUPERIORITY||Mean Difference (Net)|-0.06||||0.21|TWO_SIDED|95.0|-0.15|0.03|||t-test, 2 sided|t=-1.27, df=39.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||0.03|-0.15|.21
70960966|NCT02901041|141426519|SUPERIORITY||Mean Difference (Net)|-0.28||||0.09|TWO_SIDED|95.0|-0.6|0.04|||t-test, 2 sided|t=-1.74,df=57.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||0.04|-0.60|.09
70960967|NCT02901041|141426520|SUPERIORITY||Mean Difference (Net)|-0.35||||0.1|TWO_SIDED|95.0|-0.78|0.07|||t-test, 2 sided|t=-1.69, df=39.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||0.07|-0.78|.10
70960968|NCT02901041|141426521|SUPERIORITY||Mean Difference (Net)|0.02||||0.8|TWO_SIDED|95.0|-0.15|0.19|||t-test, 2 sided|t=0.25,df=57.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||0.19|-0.15|0.80
70960969|NCT02901041|141426522|SUPERIORITY||Mean Difference (Net)|-5.61||||0.41|TWO_SIDED|95.0|-14.56|3.34|||t-test, 2 sided|t=-0.84,df=39.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||3.34|-14.56|.41
70880853|NCT02438722|141246450|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.95|TWO_SIDED|95.0|0.73|1.39|||Log Rank|||||1.39|0.73|0.95
70960970|NCT03249714|141426528|SUPERIORITY||Rate ratio|0.064|||<|0.001|TWO_SIDED|95.0|0.018|0.232|||negative binominal regression model|||||0.232|0.018|<0.001
70960971|NCT03249714|141426529|SUPERIORITY||rate ratio|0.136||||0.003|TWO_SIDED|95.0|0.036|0.513||Statistical significance (2-sided) at the 0.05 level|negative binomial regression|||||0.513|0.036|0.003
70960972|NCT03249714|141426529|SUPERIORITY||rate ratio|0.0|||<|0.001|TWO_SIDED|95.0|0.0|0.0|||negative binominal regression|Indicates statistical significance (2-sided) at the 0.05 level.||||0.000|0.000|< 0.001
70960973|NCT03249714|141426530|SUPERIORITY||Rate ratio|0.284||||0.002|TWO_SIDED|95.0|0.13|0.62|||negative binominal regression|||||0.620|0.130|0.002
70960974|NCT03249714|141426531|SUPERIORITY||Rate ratio|0.42||||0.119|TWO_SIDED|95.0|0.141|1.25|||negative binominal regression|||||1.250|0.141|0.119
70960975|NCT01942720|141426553|SUPERIORITY_OR_OTHER||Sperman correlation coeficient|-0.7||||0.631|TWO_SIDED||||||Sperman test|||Relationship of total PillCam SB Lewis score with PGA score change from baseline visit to 6 month follow-up||||0.631
70960976|NCT01942720|141426553|SUPERIORITY_OR_OTHER||Sperman correlation coeficient|0.022||||0.882|TWO_SIDED||||||Sperman correlation|||Relationship of total PillCam SB CECDEIS score with PGA score change from baseline visit to 6 month follow-up||||0.882
70960977|NCT01942720|141426554|SUPERIORITY_OR_OTHER||Sperman correlation coefficient|0.735|||<|0.001|TWO_SIDED||||||Sperman correlation|||Relationship of PillCam SB TI Lewis scores with TI SES-CD score at baseline visit||||<0.001
70960978|NCT01942720|141426554|SUPERIORITY_OR_OTHER||Sperman correlation coefficient|0.726|||<|0.001|TWO_SIDED||||||Sperman correlation|||Relationship of PillCam SB TI CECDEIS scores with TI SES-CD score at baseline visit||||<0.001
70960979|NCT01942720|141426555|SUPERIORITY_OR_OTHER||Sperman correlation coefficient|0.493||||0.002|TWO_SIDED||||||Sperman correlation|||Relationship of PillCam SB Lewis score with TI SES-CD score change from baseline visit to 6 month follow-up||||0.002
70880854|NCT03965962|141246540|NON_INFERIORITY|The two-sided 95 percent (%) confidence interval (CI) was calculated based on the Wilson score method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentages between the test group (Group 1) and control group (Group 2) was greater than (\>) -5% at Day 28.|Difference in Percentage|-0.42|||||TWO_SIDED|95.0|-2.33|4.35||||||||4.35|-2.33|
70880855|NCT03965962|141246540|NON_INFERIORITY|The two-sided 95 % CI was calculated based on the Wilson score method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentages between the test group (Group 1) and control group (Group 3) was \> -5% at Day 28.|Difference in Percentage|0.86|||||TWO_SIDED|95.0|-1.32|6.5||||||||6.50|-1.32|
70880856|NCT00003641|141246551|SUPERIORITY_OR_OTHER_LEGACY|||||||0.964|TWO_SIDED||||||Log Rank|stratified on the stratification factors used for randomization||||||0.964
70880857|NCT00003641|141246552|SUPERIORITY_OR_OTHER_LEGACY|||||||0.558|TWO_SIDED||||||Log Rank|Stratified on the stratification factors used for randomization||||||0.558
70880858|NCT00878709|141246572|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.008|TWO_SIDED|95.0|0.49|0.9|||Log Rank|The Log-rank test is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|Invasive disease-free survival (iDFS) in neratinib arm compared to placebo arm.||0.90|0.49|0.008
70880859|NCT00878709|141246574|SUPERIORITY||Hazard Ratio (HR)|0.952||||0.6914|TWO_SIDED|95.0|0.747|1.212|||Log Rank|||The 2-sided P-value was based on stratified log-rank test (stratification factors: prior Trastuzumab (concurrent or sequential), nodal status (\<=3 or \>=4) and ER/PgR status (positive or negative). The hazard ratio and corresponding 95% CI from the stratified cox proportional hazard model were also presented.||1.212|0.747|0.6914
70880860|NCT00878709|141246575|OTHER||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.45|0.83|||||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|Disease-free survival including ductal carcinoma in situ (DFS-DCIS) in neratinib arm compared to placebo arm.||0.83|0.45|
70880861|NCT00878709|141246577|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.52|1.05|||||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|Distant disease free survival (DDFS) in neratinib arm compared to placebo arm.||1.05|0.52|
70880862|NCT00878709|141246579|OTHER||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.51|1.04|||||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|Time to distant recurrence (TTDR) in neratinib arm compared to placebo arm.||1.04|0.51|
70880863|NCT00878709|141246583|OTHER||Hazard Ratio (HR)|0.73||||0.008|TWO_SIDED|95.0|0.57|0.92||The Log-rank test is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|Log Rank||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|Invasive disease-free survival (iDFS) in neratinib arm compared to placebo arm.||0.92|0.57|0.008
70880864|NCT00878709|141246585|OTHER||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.56|0.89|||||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|||0.89|0.56|
70880865|NCT00878709|141246586|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.6|1.01|||||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|||1.01|0.6|
70880866|NCT00878709|141246587|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.6|1.03|||||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|||1.03|0.60|
70880867|NCT05214768|141246596|SUPERIORITY||Least Square Mean Difference|-223.2|STANDARD_ERROR_OF_MEAN|74.98||0.003|TWO_SIDED|95.0|-370.2|-76.3|||ANCOVA|||||-76.3|-370.2|0.003
70880868|NCT04303780|141246630|EQUIVALENCE|A hazard ratio \<1.0 indicates a lower average event rate and a longer PFS for AMG 510 relative to docetaxel. P-value was calculated using a stratified log-rank test.|Hazard Ratio (HR)|0.663||||0.002|TWO_SIDED|95.0|0.509|0.864|||Log Rank|||||0.864|0.509|0.002
70880869|NCT00483223|141246632|OTHER|||||||0.54|||||||t-test, 2 sided|||H0: no association between expression ratio and response rate Ha: Participants with expression ratio greater than 2 would have higher response rate||||0.54
70880870|NCT01344161|141246635|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.001|TWO_SIDED|95.0|||||ANCOVA|An analysis of covariance (ANCOVA) was used to adjust mean differences on all variables.||||||0.001
70880871|NCT00066066|141246668|SUPERIORITY_OR_OTHER||||||>|0.05||||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in non-smokers was tested by comparing change in mean CAL in individuals at 3 months post-therapy.||||>0.05
70880872|NCT00066066|141246668|SUPERIORITY_OR_OTHER||||||>|0.05||||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in non-smokers was tested by comparing change in mean CAL in individuals at 6 months post-therapy.||||>0.05
70880873|NCT00066066|141246668|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in non-smokers was tested by comparing change in mean CAL in individuals at 12 months post-therapy.||||<0.05
70880874|NCT00066066|141246668|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in smokers was tested by comparing change in mean CAL in individuals at 3 months post-therapy.||||<0.05
70880875|NCT00066066|141246668|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in smokers was tested by comparing change in mean CAL in individuals at 6 months post-therapy.||||<0.05
70880876|NCT00066066|141246668|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in smokers was tested by comparing change in mean CAL in individuals at 12 months post-therapy.||||>0.05
70880877|NCT01925404|141246834|SUPERIORITY|We fitted difference-in-differences (DID) models between the two measurement waves and four study arms. The effect of the intervention was modeled as the wave by study arm interaction. All models used random effects to account for intra-class correlation within each park as well as fixed effects to account for observation times (time of day, weekend versus weekdays).||||||0.0063||||||Significance threshold. p=0.05|negative binomial distribution|||Comparison of change from baseline;||||.0063
70880878|NCT04091646|141246836|SUPERIORITY||Odds Ratio (OR)|4.95|||<|0.0001|TWO_SIDED|95.0|2.51|9.76|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with multiple imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|IGA Success at Week 8 Odds Ratio||9.76|2.51|<0.0001
70880879|NCT04091646|141246837|SUPERIORITY||Odds Ratio (OR)|3.31||||0.0033|TWO_SIDED|95.0|1.46|7.52|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with multiple imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|IGA Success at Week 2 Odds Ratio||7.52|1.46|0.0033
70880880|NCT04091646|141246837|SUPERIORITY||Odds Ratio (OR)|3.78||||0.0002|TWO_SIDED|95.0|1.94|7.38|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with multiple imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|IGA Success at Week 4 Odds Ratio||7.38|1.94|0.0002
70880881|NCT04091646|141246838|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 2 Erythema Score||||<0.0001
70880882|NCT04091646|141246838|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 4 Erythema Score||||<0.0001
70880883|NCT04091646|141246838|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 8 Erythema Score||||<0.0001
70960980|NCT01942720|141426555|SUPERIORITY_OR_OTHER||Sperman correlation coefficient|0.531|||<|0.001|TWO_SIDED||||||Sperman correlation|||Relationship of PillCam SB CECDEIS score with TI SES-CD score change from baseline visit to 6 month follow-up||||<0.001
70960981|NCT01942720|141426556|SUPERIORITY_OR_OTHER||Sperman correlation coefficient|0.752|||<|0.001|TWO_SIDED||||||Sperman correlation|||Relationship of PillCam total SB Lewis score change with TI Leis score change from baseline visit to 6 month follow-up||||<0.001
70960982|NCT01942720|141426556|SUPERIORITY_OR_OTHER||Sperman correlation coefficient|0.785|||<|0.001|TWO_SIDED||||||Sperman correlation|||Relationship of PillCam total SB CECDEIS score change with TI Leis score change from baseline visit to 6 month follow-up||||<0.001
70960983|NCT03952806|141426565|SUPERIORITY||Least Square mean difference|0.35|STANDARD_ERROR_OF_MEAN|0.48||0.4656|TWO_SIDED|95.0|-0.6|1.3|||Mixed Models Analysis|||||1.30|-0.60|0.4656
70960984|NCT01138007|141426576|SUPERIORITY_OR_OTHER||Least Squared Mean Difference|-0.5||||0.853|TWO_SIDED|95.0|-2.7|1.7||The p-value was estimated based on the ANCOVA model including Baseline MADRS score and region as covariates. The multiplicity was adjusted by Dunnett's step-down procedure.|ANCOVA||The confidence interval was estimated based on the ANCOVA model including Baseline MADRS score and region as covariates.|||1.7|-2.7|0.853
70960985|NCT01138007|141426576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|1.0||||95.0|||||||In the analysis plan, the second comparison of interest was not to be performed if the first comparison failed to show statistical significance.|||||
70960986|NCT01806129|141426597|SUPERIORITY||Odds Ratio (OR)|2.07|||||TWO_SIDED|90.0|1.29|3.31|||||Odds ratio represents the odds of adopting the appropriate reproductive health management for patients with intervention compared to the odds among patients without intervention. Odds ratio was calculated by GEE analysis.|||3.31|1.29|
70960987|NCT00744523|141426603|SUPERIORITY_OR_OTHER||proportion of the primary endpoint|2.7|STANDARD_ERROR_OF_MEAN|5.0|<|0.05|ONE_SIDED|95.0||5.2|||t-test, 1 sided||"Parameter Dispersion Type of Standard Error of the mean is meant to state that 'mean is the mean of proportions in the sense of a central-limit theorem"|The ARMOUR trial tested the null hypothesis that the MACCE rate was greater than or equal to the Performance Goal (PG) of 13% versus the alternative hypothesis that the true MACCE rate was less than the PG. The sample size was calculated based on 90% power and a Type I error rate of 0.05 (one-sided). The Performance Goal was calculated from results of carotid artery stenting trials that utilized embolic protection devices (EPD).||5.2||<0.05
70960988|NCT00394953|141426702|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.63|||<|0.0001|TWO_SIDED|95.0|1.83|3.79|||Chi-squared, Corrected|||The proportion of responders treated with methoxy polyethylene glycol-epoetin beta versus the proportion of responders treated with darbepoetin alpha during the evaluation period.||3.79|1.83|<0.0001
70960989|NCT04079803|141426730|SUPERIORITY|||||||0.087||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes two 100 mg subjects who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing two subjects with no detectable simufilam in plasma, P=0.0088 and CFB was 13.4. In percent change from baseline with these two subjects removed, P=0.004.|||0.087
70960990|NCT04079803|141426730|SUPERIORITY|||||||0.01||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes one 50 mg subject who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing one subject with no detectable simufilam in plasma, P=0.0006 and CFB was 16.9. In percent change from baseline with this subject removed, P=0.0004.|||0.01
70960991|NCT04079803|141426731|SUPERIORITY||||||<|0.0001||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes two 100 mg subjects who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing two subjects with no detectable simufilam in plasma, P\<0.0001 and CFB was -19.8.|||<0.0001
70960992|NCT04079803|141426731|SUPERIORITY|||||||0.0012||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes one 50 mg subject who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing one subject with no detectable simufilam in plasma, P=0.001 and CFB was -14.9.|||0.0012
70960993|NCT04079803|141426732|SUPERIORITY|||||||0.005||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes two 100 mg subjects who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing two subjects with no detectable simufilam in plasma, P=0.003 and CFB was -3.2.|||0.005
70960994|NCT04079803|141426732|SUPERIORITY|||||||0.002||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes one 50 mg subject who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing one subject with no detectable simufilam in plasma, P=0.003 and CFB was -2.5.|||0.002
70960995|NCT04079803|141426733|SUPERIORITY|||||||0.0002||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes two 100 mg subjects who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing two subjects with no detectable simufilam in plasma, P=0.0002 and CFB was -681.|||0.0002
70960996|NCT04079803|141426733|SUPERIORITY|||||||0.0005||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes one 50 mg subject who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing one subject with no detectable simufilam in plasma, P=0.0005 and CFB was -527.|||0.0005
70960997|NCT04079803|141426734|SUPERIORITY|||||||0.0003||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes two 100 mg subjects who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing two subjects with no detectable simufilam in plasma, P=0.0002 and CFB was -78.5.|||0.0003
70960998|NCT04079803|141426734|SUPERIORITY|||||||0.0058||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes one 50 mg subject who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing one subject with no detectable simufilam in plasma, P=0.0008 and CFB was -51.0.|||0.0058
70960999|NCT04079803|141426735|SUPERIORITY|||||||0.0001||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes two 100 mg subjects who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing two subjects with no detectable simufilam in plasma, P=0.0001 and CFB was -23.7.|||0.0001
70961000|NCT04079803|141426735|SUPERIORITY|||||||0.0001||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes one 50 mg subject who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing one subject with no detectable simufilam in plasma, P=0.0002 and CFB was -20.9.|||0.0001
70961001|NCT04079803|141426736|OTHER||Effect size|0.23|||||TWO_SIDED||||||||Reported effect size vs. placebo was calculated with Hedge's g (for groups of 20 or fewer) but was identical when calculated by Cohen's d.|This study was not powered for statistical significance on cognitive measures.||||
70961002|NCT04079803|141426736|OTHER||Effect size|0.37|||||TWO_SIDED||||||||Reported effect size vs. placebo was calculated with Hedge's g (for groups of 20 or fewer) but was identical when calculated by Cohen's d.|This study was not powered for statistical significance on cognitive measures.||||
70961003|NCT04079803|141426737|OTHER||Effect size|0.46|||||TWO_SIDED||||||||Reported effect size vs. placebo was calculated with Hedge's g (for groups of 20 or fewer) but was almost identical (0.45) when calculated by Cohen's d.|This study was not powered for statistical significance on cognitive measures.||||
70880884|NCT04091646|141246839|SUPERIORITY||Odds Ratio (OR)|5.05||||0.0065|TWO_SIDED|95.0|1.49|17.13|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data||Erythema Success at Week 2||17.13|1.49|0.0065
70961004|NCT04079803|141426737|OTHER||Effect size|0.25|||||TWO_SIDED||||||||Reported effect size vs. placebo was calculated with Hedge's g (for groups of 20 or fewer) but was identical when calculated by Cohen's d.|This study was not powered for statistical significance on cognitive measures.||||
70961005|NCT04079803|141426738|SUPERIORITY|||||||0.0078||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for IL-6.||||0.0078
70961006|NCT04079803|141426738|SUPERIORITY|||||||0.019||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for IL-6.||||0.019
70961007|NCT04079803|141426738|SUPERIORITY|||||||0.0002||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for sTREM2.||||0.0002
70961008|NCT04079803|141426738|SUPERIORITY|||||||0.0007||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for sTREM2.||||0.0007
70961009|NCT04079803|141426738|SUPERIORITY|||||||0.0001||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for HMGB1.||||0.0001
70880885|NCT04091646|141246839|SUPERIORITY||Odds Ratio (OR)|5.36||||0.0002|TWO_SIDED|95.0|2.15|13.38|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data||Erythema Success at Week 4||13.38|2.15|0.0002
70880886|NCT04091646|141246839|SUPERIORITY||Odds Ratio (OR)|3.15||||0.0021|TWO_SIDED|95.0|1.5|6.63|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data||Erythema Success at Week 8||6.63|1.50|0.0021
70880887|NCT04091646|141246840|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 2 Scaling Score||||<0.0001
70880888|NCT04091646|141246840|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 4 Scaling Score||||<0.0001
70880889|NCT04091646|141246840|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 8 Scaling Score||||<0.0001
70880890|NCT04091646|141246841|SUPERIORITY||Odds Ratio (OR)|1.98||||0.0759|TWO_SIDED|95.0|0.9|4.33|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with no imputation of missing data.|Scaling Success at Week 2||4.33|0.90|0.0759
70880891|NCT04091646|141246841|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0122|TWO_SIDED|95.0|1.18|4.61|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with no imputation of missing data.|Scaling Success at Week 4||4.61|1.18|0.0122
70880892|NCT04091646|141246841|SUPERIORITY||Odds Ratio (OR)|3.37||||0.0003|TWO_SIDED|95.0|1.74|6.55|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with no imputation of missing data.|Scaling Success at Week 8||6.55|1.74|0.0003
70880893|NCT04091646|141246843|SUPERIORITY||Odds Ratio (OR)|3.62||||0.0007|TWO_SIDED|95.0|1.72|7.63|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with no imputation of missing data.|WI-NRS Success at Week 2||7.63|1.72|0.0007
70880894|NCT04091646|141246843|SUPERIORITY||Odds Ratio (OR)|3.3||||0.0009|TWO_SIDED|95.0|1.63|6.68|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with no imputation of missing data.|WI-NRS Success at Week 4||6.68|1.63|0.0009
70880895|NCT04091646|141246843|SUPERIORITY||Odds Ratio (OR)|3.19||||0.0007|TWO_SIDED|95.0|1.6|6.35|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with no imputation of missing data.|WI-NRS Success at Week 8||6.35|1.60|0.0007
70880896|NCT00159588|141246867|SUPERIORITY|||||||0.056||||||Between-group analysis|Kruskal-Wallis|||Kruskal-Wallis test||||0.056
70880897|NCT00159588|141246868|SUPERIORITY|Between-group analysis||||||0.012||||||Between-group analysis|t-test, 2 sided|Kruskal-Wallis test||Kruskal-Wallis test||||0.012
70961010|NCT04079803|141426738|SUPERIORITY|||||||0.0001||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for HMGB1.||||0.0001
70961011|NCT04079803|141426738|SUPERIORITY|||||||0.0001||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for albumin.||||0.0001
70961012|NCT04079803|141426738|SUPERIORITY|||||||0.046||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for albumin.||||0.046
70961013|NCT04079803|141426738|SUPERIORITY|||||||0.012||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for Immunoglobulin G.||||0.012
70961014|NCT04079803|141426738|SUPERIORITY|||||||0.014||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for Immunoglobulin G.||||0.014
70961015|NCT04079803|141426739|SUPERIORITY|||||||0.005||||||As secondary endpoints, lymphocyte biomarkers were not adjusted for multiplicity.|ANOVA|ANOVA was used instead of ANCOVA due to the range in baseline values; it was deemed more appropriate to compare to each subject's own baseline value.||Change from baseline in FLNA linkage to alpha7nAChR in subject lymphocytes. FLNA linkage to alpha7nAChR was expressed as the ratio of densitometric units of immunoblot bands of alpha7nAChR (probed with a specific antibody) to densitometric units of total FLNA.||||0.005
70961016|NCT04079803|141426739|SUPERIORITY|||||||0.009||||||As secondary endpoints, lymphocyte biomarkers were not adjusted for multiplicity.|ANOVA|ANOVA was used instead of ANCOVA due to the range in baseline values; it was deemed more appropriate to compare to each subject's own baseline value.||Change from baseline in FLNA linkage to alpha7nAChR in subject lymphocytes. FLNA linkage to alpha7nAChR was expressed as ratios of densitometric units of immunoblot bands of alpha7nAChR (probed with a specific antibody) to densitometric units of total FLNA.||||0.009
70961017|NCT04079803|141426739|SUPERIORITY|||||||0.01||||||As secondary endpoints, lymphocyte biomarkers were not adjusted for multiplicity.|ANOVA|ANOVA was used instead of ANCOVA due to the range in baseline values; it was deemed more appropriate to compare to each subject's own baseline value.||Change from baseline in FLNA linkage to TLR4 in subject lymphocytes. FLNA linkage to TLR4 was expressed as the ratio of densitometric units of immunoblot bands of TLR4 (probed with a specific antibody) to densitometric units of total FLNA.||||0.01
70961018|NCT04079803|141426739|SUPERIORITY|||||||0.01||||||As secondary endpoints, lymphocyte biomarkers were not adjusted for multiplicity.|ANOVA|ANOVA was used instead of ANCOVA due to the range in baseline values; it was deemed more appropriate to compare to each subject's own baseline value.||Change from baseline in FLNA linkage to TLR4 in subject lymphocytes. FLNA linkage to TLR4 was expressed as the ratio of densitometric units of immunoblot bands of TLR4 (probed with a specific antibody) to densitometric units of total FLNA.||||0.01
70961019|NCT04079803|141426740|SUPERIORITY|||||||0.01|||||||ANOVA|ANOVA followed by Dunnett's multiple comparisons test.||||||0.01
70961020|NCT04079803|141426740|SUPERIORITY|||||||0.02|||||||ANOVA|ANOVA followed by Dunnett's multiple comparisons test.||||||0.02
70961021|NCT04079803|141426740|SUPERIORITY|||||||0.009|||||||ANOVA|This p value is for the main effect of treatment of the ANOVA.||||||0.009
70961022|NCT04079803|141426741|SUPERIORITY|||||||0.003|||||||ANOVA|||||||0.003
70961023|NCT04079803|141426741|SUPERIORITY|||||||0.016|||||||ANOVA|||||||0.016
70961024|NCT01294683|141426748|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.206||||0.654|TWO_SIDED|95.0|-1.434|0.936|||Miettinen and Nurminen|||Periods I/II||0.936|-1.434|0.654
70961025|NCT01294683|141426748|SUPERIORITY_OR_OTHER||Difference in Percentages|1.304||||0.09|TWO_SIDED|95.0|-0.427|3.768|||Miettinen and Nurminen|||Period III||3.768|-0.427|0.090
70961026|NCT01294683|141426749|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.206||||0.563|TWO_SIDED|95.0|-1.303|0.779|||Miettinen and Nurminen|||Periods I/II||0.779|-1.303|0.563
70961027|NCT01294683|141426749|SUPERIORITY_OR_OTHER||Difference in Percentages|0.87||||0.166|TWO_SIDED|95.0|-0.858|3.118|||Miettinen and Nurminen|||Period III||3.118|-0.858|0.166
70961028|NCT01294683|141426751|SUPERIORITY_OR_OTHER||Difference in Percentages|0.87||||0.166|TWO_SIDED|95.0|-0.858|3.118|||Miettinen and Nurminen|||Period III||3.118|-0.858|0.166
70961029|NCT01294683|141426754|SUPERIORITY_OR_OTHER||Difference in Percentages|0.617||||0.255|TWO_SIDED|95.0|-0.575|2.023|||Miettinen and Nurminen|||Periods I/II||2.023|-0.575|0.255
70880898|NCT02066467|141246869|OTHER||||||<|0.0001|||||||exact binominal methodology|||||||<0.0001
70961030|NCT01294683|141426754|SUPERIORITY_OR_OTHER||Difference in Percentages|0.395||||0.69|TWO_SIDED|95.0|-2.091|2.966|||Miettinen and Nurminen|||Period III||2.966|-2.091|0.690
70961031|NCT01294683|141426755|SUPERIORITY_OR_OTHER||Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-0.967|0.967|||Miettinen and Nurminen|||Periods I/II||0.967|-0.967|>0.999
70961032|NCT01294683|141426756|SUPERIORITY_OR_OTHER||Difference in Percentages|-1.029|||||TWO_SIDED|95.0|-7.301|5.252|||Miettinen and Nurminen||Miettinen and Nurminen Method|Periods I/II||5.252|-7.301|
70961033|NCT01294683|141426756|SUPERIORITY_OR_OTHER||Difference in Percentages|0.889|||||TWO_SIDED|95.0|-7.599|9.338|||||Miettinen and Nurminen Method|Period III||9.338|-7.599|
70961034|NCT01294683|141426757|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.412|||||TWO_SIDED|95.0|-4.28|3.45||||||Periods I/II||3.450|-4.280|
70961035|NCT01294683|141426757|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.533|||||TWO_SIDED|95.0|-3.916|2.619|||||Miettinen and Nurminen Method|Period III||2.619|-3.916|
70961036|NCT00412971|141426778|SUPERIORITY_OR_OTHER||difference in recurrence rate|0.25||||0.05|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.05
70961037|NCT01296347|141426788|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
70961038|NCT01296347|141426789|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||6 weeks||||0.71
70961039|NCT01296347|141426789|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||3 month||||1.0
70961040|NCT01296347|141426789|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||6 months||||0.32
70961041|NCT01296347|141426791|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
70961042|NCT01296347|141426792|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
70961043|NCT01296347|141426793|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
70961044|NCT01296347|141426794|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
70961045|NCT01585987|141426795|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.439||||0.0972|TWO_SIDED|80.0|1.085|1.908||Significance level used: 0.2|Log Rank||The hazard ratio and its associated two-sided 80% confidence interval (CI) was estimated via a stratified Cox model with treatment arm as the only covariate in the model|||1.908|1.085|0.0972
70961046|NCT01585987|141426796|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.588||||0.0336|TWO_SIDED|80.0|1.199|2.103||Significance level used: 0.2|Log Rank|||||2.103|1.199|0.0336
70880899|NCT02066467|141246871|OTHER||||||<|0.0001|||||||exact binominal methodology|||||||<0.0001
70880900|NCT00456521|141246872|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.21|||<|0.001||95.0|-5.56|-2.86|||ANCOVA|||||-2.86|-5.56|<0.001
70961047|NCT01585987|141426797|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.874||||0.6433|TWO_SIDED|80.0|0.602|1.269||Significance level used: 0.2|Log Rank||HR was based on a stratified Cox proportional hazards model with treatment arm as the only covariate in the model.|||1.269|0.602|0.6433
70961048|NCT01585987|141426799|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0549||||0.3686|TWO_SIDED|80.0|0.7009|47.6447||Significance level used: 0.2|Cochran-Mantel-Haenszel|||||47.6447|0.7009|0.3686
70961049|NCT01783041|141426827|OTHER||||||<|0.05||||||These are calculated p values.|ANOVA|Differences in continuous and categorical variables were compared using ANOVA and either Chi square test or Fisher's exact test, respectively.||||||<0.05
70961050|NCT01783041|141426828|OTHER||||||<|0.05||||||These are calculated p values.|Wilcoxon (Mann-Whitney)|This analysis applies to all sub-scales that were compared between the 2 study groups.||||||<0.05
70961051|NCT01783041|141426829|OTHER||||||<|0.05||||||Reported p values have been calculated.|t-test, 2 sided|Differences between the groups were analyzed using a two sided t-test.||||||<0.05
70961052|NCT01783041|141426830|OTHER||||||<|0.05||||||These are calculated p values.|ANOVA|Differences in continuous and categorical variables were compared using ANOVA and either Chi square test or Fisher's exact test, respectively.||||||<0.05
70961053|NCT03170154|141426849|OTHER||1-sided 95% Upper CL|99.99|||||ONE_SIDED||||||||Historical comparison to EN ISO 11979-7:2014: SPE rate of at least 92.5 for the AAS at 12 months.|||||
70961054|NCT03170154|141426850|OTHER||1-sided 95% Upper CL|99.98|||||ONE_SIDED|95.0|||||||Historical comparison to EN ISO 11979-7:2014: SPE rate of at least 96.7 for the BAS at 12 months.|||||
70961055|NCT05266586|141426855|SUPERIORITY||Least Squares (LS) Means|-58.38|STANDARD_ERROR_OF_MEAN|5.138|<|0.0001|TWO_SIDED|95.0|-68.59|-48.18|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-48.18|-68.59|<.0001
70961056|NCT05266586|141426856|SUPERIORITY||Least Squares (LS) Means|-58.38|STANDARD_ERROR_OF_MEAN|5.138|<|0.0001|TWO_SIDED|95.0|-68.59|-48.18|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-48.18|-68.59|<.0001
70961057|NCT05266586|141426857|SUPERIORITY||Least Squares (LS) Means|-58.38|STANDARD_ERROR_OF_MEAN|5.138|<|0.0001|TWO_SIDED|95.0|-68.59|-48.18|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-48.18|-68.59|<.0001
70961058|NCT05266586|141426858|SUPERIORITY||Least Squares (LS) Means|-58.15|STANDARD_ERROR_OF_MEAN|5.195|<|0.0001|TWO_SIDED|95.0|-68.47|-47.83|||ANCOVA|||||-47.83|-68.47|<.0001
70961059|NCT05266586|141426859|SUPERIORITY||Least Squares (LS) Means|-58.15|STANDARD_ERROR_OF_MEAN|5.195|<|0.0001|TWO_SIDED|95.0|-68.47|-47.83|||ANCOVA|||||-47.83|-68.47|<.0001
70961060|NCT05266586|141426860|SUPERIORITY||Least Squares (LS) Means|-58.15|STANDARD_ERROR_OF_MEAN|5.195|<|0.0001|TWO_SIDED|95.0|-68.47|-47.83|||ANCOVA|||||-47.83|-68.47|<.0001
70961061|NCT05266586|141426861|SUPERIORITY||Least Squares (LS) Means|-38.35|STANDARD_ERROR_OF_MEAN|5.397|<|0.0001|TWO_SIDED|95.0|-49.07|-27.63|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-27.63|-49.07|<.0001
70961062|NCT05266586|141426862|SUPERIORITY||Least Squares (LS) Means|-38.35|STANDARD_ERROR_OF_MEAN|5.397|<|0.0001|TWO_SIDED|95.0|-49.07|-27.63|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-27.63|-49.07|<.0001
70961063|NCT05266586|141426863|SUPERIORITY||Least Squares (LS) Means|-38.35|STANDARD_ERROR_OF_MEAN|5.397|<|0.0001|TWO_SIDED|95.0|-49.07|-27.63|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-27.63|-49.07|<.0001
70961064|NCT05266586|141426864|SUPERIORITY||Least Squares (LS) Means|-37.21|STANDARD_ERROR_OF_MEAN|5.465|<|0.0001|TWO_SIDED|95.0|-48.07|-26.35|||ANCOVA|||||-26.35|-48.07|<.0001
70961065|NCT05266586|141426865|SUPERIORITY||Least Squares (LS) Means|-37.21|STANDARD_ERROR_OF_MEAN|5.465|<|0.0001|TWO_SIDED|95.0|-48.07|-26.35|||ANCOVA|||||-26.35|-48.07|<.0001
70961066|NCT05266586|141426866|SUPERIORITY||Least Squares (LS) Means|-37.21|STANDARD_ERROR_OF_MEAN|5.465|<|0.0001|TWO_SIDED|95.0|-48.07|-26.35|||ANCOVA|||||-26.35|-48.07|<.0001
70961067|NCT05266586|141426867|SUPERIORITY||Least Squares (LS) Means|-35.68|STANDARD_ERROR_OF_MEAN|3.8|<|0.0001|TWO_SIDED|95.0|-43.23|-28.13|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-28.13|-43.23|<.0001
70961068|NCT05266586|141426868|SUPERIORITY||Least Squares (LS) Means|-35.68|STANDARD_ERROR_OF_MEAN|3.8|<|0.0001|TWO_SIDED|95.0|-43.23|-28.13|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-28.13|-43.23|<.0001
70961069|NCT05266586|141426869|SUPERIORITY||Least Squares (LS) Means|-35.68|STANDARD_ERROR_OF_MEAN|3.8|<|0.0001|TWO_SIDED|95.0|-43.23|-28.13|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-28.13|-43.23|<.0001
70880901|NCT00456521|141246873|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.89|||<|0.001||95.0|2.02|4.13|||Regression, Logistic|||||4.13|2.02|<0.001
70961070|NCT05266586|141426870|SUPERIORITY||Least Squares (LS) Means|-22.28|STANDARD_ERROR_OF_MEAN|3.991|<|0.0001|TWO_SIDED|95.0|-30.21|-14.36|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.36|-30.21|<.0001
70961071|NCT05266586|141426871|SUPERIORITY||Least Squares (LS) Means|-22.28|STANDARD_ERROR_OF_MEAN|3.991|<|0.0001|TWO_SIDED|95.0|-30.21|-14.36|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.36|-30.21|<.0001
70961072|NCT05266586|141426872|SUPERIORITY||Least Squares (LS) Means|-22.28|STANDARD_ERROR_OF_MEAN|3.991|<|0.0001|TWO_SIDED|95.0|-30.21|-14.36|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.36|-30.21|<.0001
70961073|NCT03282240|141426873|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is \> 0.667 for each of the comparisons.|GMT Ratio (QIV-HD/TIV-HDs)|1.08|||||TWO_SIDED|95.0|0.958|1.224||||||B Victoria: The 2-sided 95% confidence interval (CI) was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.||1.224|0.958|
70961074|NCT03282240|141426873|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is \> 0.667 for each of the comparisons.|GMT Ratio (QIV-HD/TIV-HDs)|1.0|||||TWO_SIDED|95.0|0.881|1.129||||||B Yamagata: The 2-sided 95% CI was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.||1.129|0.881|
70961075|NCT03282240|141426873|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is \> 0.667 for each of the comparisons.|GMT Ratio (QIV-HD/TIV-HDs)|0.83|||||TWO_SIDED|95.0|0.744|0.932||||||A/H1N1: The 2-sided 95% CI was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.||0.932|0.744|
70961076|NCT03282240|141426873|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is \> 0.667 for each of the comparisons.|GMT Ratio (QIV-HD/TIV-HDs)|0.95|||||TWO_SIDED|95.0|0.842|1.066||||||A/H3N2: The 2-sided 95% CI was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.||1.066|0.842|
70961077|NCT03282240|141426874|NON_INFERIORITY|Non-inferiority in seroconversion was concluded if the lower limit of the 2-sided 95% CI of the differences of seroconversion rates between groups is \> -10%.|Difference in Percentage|-2.41|||||TWO_SIDED|95.0|-7.66|2.7||||||B Victoria: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.||2.70|-7.66|
70961078|NCT03282240|141426874|NON_INFERIORITY|Non-inferiority in seroconversion was concluded if the lower limit of the 2-sided 95% CI of the differences of seroconversion rates between groups is \> -10%.|Difference in Percentage|-1.75|||||TWO_SIDED|95.0|-7.04|3.53||||||B Yamagata: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.||3.53|-7.04|
70961079|NCT03282240|141426874|NON_INFERIORITY|Non-inferiority in seroconversion was concluded if the lower limit of the 2-sided 95% CI of the differences of seroconversion rates between groups is \> -10%.|Difference in Percentage|-0.71|||||TWO_SIDED|95.0|-4.83|3.42||||||A/H3N2: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.||3.42|-4.83|
70961080|NCT03282240|141426874|NON_INFERIORITY|Non-inferiority in seroconversion was concluded if the lower limit of the 2-sided 95% CI of the differences of seroconversion rates between groups is \> -10%.|Difference in Percentage|-3.27|||||TWO_SIDED|95.0|-7.37|0.86||||||A/H1N1: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.||0.86|-7.37|
70961081|NCT03282240|141426875|SUPERIORITY|Superiority in GMTs was observed if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups was \> 1.5 for comparison group.|GMT Ratio (QIV-HD/TIV-HDs)|2.04|||||TWO_SIDED|95.0|1.804|2.315||||||The 2-sided 95% CI is based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.||2.315|1.804|
70961082|NCT03282240|141426875|SUPERIORITY|Superiority in GMTs was observed if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups was \> 1.5 for comparison group.|GMT Ratio (QIV-HD/TIV-HDs)|2.03|||||TWO_SIDED|95.0|1.802|2.288||||||The 2-sided 95% CI is based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.||2.288|1.802|
70961083|NCT03282240|141426877|SUPERIORITY|Superiority in seroconversion was observed if the lower limit of the 2-sided 95% CI of the difference of seroconversion rates between groups is \> 10% for each applicable comparison.|Difference in Percentage|29.27|||||TWO_SIDED|95.0|24.78|33.29||||||B Yamagata: The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.||33.29|24.78|
70961084|NCT03282240|141426877|SUPERIORITY|Superiority in seroconversion was observed if the lower limit of the 2-sided 95% CI of the difference of seroconversion rates between groups is \> 10% for each applicable comparison.|Difference in Percentage|20.78|||||TWO_SIDED|95.0|16.5|24.61||||||B Victoria: The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.||24.61|16.5|
70961085|NCT01101477|141426889|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||The patients with at lease one episode of hypoxemia (SPaO2\<90%) during FB were analyzed by Chi-square test. P value less 0.05 means significance, 2-sided.||||0.05
70961086|NCT02382016|141426895|SUPERIORITY||ratio of geometric means|0.65||||0.0001|TWO_SIDED|95.0|0.59|0.72|||ANCOVA|ANCOVA model adjusted by treatment, background PAH-specific therapy at baseline and region as factors \& log-transformed PVR at baseline as a covariate||The null hypothesis (change of PVR at Week 12 as a ratio of baseline PVR in subjects treated with placebo or macitentan is the same) is tested on the primary endpoint by means of an analysis of covariance (ANCOVA) model on the log(e) transformed ratio of PVR at Week 12 to baseline PVR.||0.72|0.59|0.0001
70961087|NCT02382016|141426896|SUPERIORITY||Least squares (LS) mean difference|9.73||||0.4264|TWO_SIDED|95.0|-14.5|33.95||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|mixed-effect model repeated measure||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in 6MWD (LS mean difference macitentan 10 mg - placebo).|The main analysis on 6MWD was performed using a mixed-effect model repeated measure (MMRM) adjusted for treatment, visit, region, PAH-specific therapy at baseline, and treatment-by-visit interaction as factors, and baseline 6MWD and WHO functional class (FC) as covariates.||33.95|-14.50|0.4264
70961088|NCT02382016|141426897|SUPERIORITY||Odds Ratio (OR)|6.253||||0.1278|TWO_SIDED|95.0|0.714|298.376||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|Regression, Logistic|||A logistic regression model (exact) adjusted for treatment, PAH-specific therapy at baseline, and region as covariates was used to analyze worsening in WHO FC.||298.376|0.714|0.1278
70961089|NCT02382016|141426898|SUPERIORITY||ratio of geometric means|0.874||||0.3951|TWO_SIDED|95.0|0.639|1.196||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA|||||1.196|0.639|0.3951
70961090|NCT02382016|141426899|SUPERIORITY||Least squares (LS) mean difference|1.67||||0.0637|TWO_SIDED|95.0|-0.1|3.44||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in mRAP (LS mean difference macitentan 10 mg - placebo).|||3.44|-0.10|0.0637
70880902|NCT00456521|141246874|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.92|||<|0.001|TWO_SIDED|95.0|1.95|4.37|||Regression, Logistic|||||4.37|1.95|<0.001
70880903|NCT00456521|141246875|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.21|||<|0.001|TWO_SIDED|95.0|-4.82|-1.6|||ANCOVA|||||-1.60|-4.82|<0.001
70880904|NCT00456521|141246876|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.11||||0.004|TWO_SIDED||||||ANCOVA|||||||0.004
70880905|NCT00456521|141246877|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.53||||0.003|TWO_SIDED||||||ANCOVA|||||||0.003
70880906|NCT00456521|141246878|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.23|||<|0.001|TWO_SIDED|95.0|1.52|4.95|||ANCOVA|||||4.95|1.52|<0.001
70880907|NCT00456521|141246879|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.14||||0.001|TWO_SIDED|95.0|1.23|5.04|||ANCOVA|||||5.04|1.23|0.001
70880908|NCT00456521|141246880|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.37||||0.003|TWO_SIDED||||||ANCOVA|||||||0.003
70880909|NCT00456521|141246881|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.98||||0.165|TWO_SIDED||||||ANCOVA|||||||0.165
70880910|NCT00456521|141246882|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.28|||||TWO_SIDED|95.0|-3.34|0.79||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.79|-3.34|
70880911|NCT00456521|141246883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7|||||TWO_SIDED|95.0|-7.26|1.86||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.86|-7.26|
70880912|NCT00456521|141246884|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.55|||||TWO_SIDED|95.0|0.97|4.14||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||4.14|0.97|
70880913|NCT00456521|141246885|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.37|||||TWO_SIDED|95.0|0.25|2.49||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||2.49|0.25|
70880914|NCT00456521|141246886|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09|||||TWO_SIDED|95.0|-0.7|0.87||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.87|-0.70|
70880915|NCT00456521|141246887|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|||||TWO_SIDED|95.0|-0.85|0.63||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.63|-0.85|
70880916|NCT00456521|141246888|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09|||||TWO_SIDED|95.0|-0.78|0.6||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.60|-0.78|
70880917|NCT00456521|141246889|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.29|||||TWO_SIDED|95.0|-9.16|-1.42||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||-1.42|-9.16|
70880918|NCT03615326|141246972|SUPERIORITY|The hazard ratio (HR) and its 95% confidence interval (CI) were estimated using a stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status (positive vs. negative) at baseline, and chemotherapy regimen (FP or CAPOX).|Hazard Ratio (HR)|0.73||||0.0002|TWO_SIDED|95.0|0.61|0.87|||Log Rank|One-sided p-value based on log-rank test stratified by geographic region, PD-L1 status, and chemotherapy regimen with small strata collapsed.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status, and chemotherapy regimen with small strata collapsed.|PFS in all participants of the Global Pembrolizumab + SOC First Course was compared to PFS in all participants of the Global Standard of Care to address the hypothesis (pembrolizumab in combination with trastuzumab plus chemotherapy is superior to trastuzumab plus chemotherapy alone).||0.87|0.61|0.0002
70880919|NCT03615326|141246973|SUPERIORITY|The hazard ratio (HR) and its 95% confidence interval (CI) were estimated using a stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status (positive vs. negative) at baseline, and chemotherapy regimen (FP or CAPOX).|Hazard Ratio (HR)|0.8||||0.004|TWO_SIDED|95.0|0.67|0.94|||Log Rank|One-sided p-value based on log-rank test stratified by geographic region, PD-L1 status, and chemotherapy regimen with small strata collapsed.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status, and chemotherapy regimen with small strata collapsed.|OS in all participants of the Global Pembrolizumab + SOC First Course was compared to PFS in all participants of the Global Standard of Care to address the hypothesis (pembrolizumab in combination with trastuzumab plus chemotherapy is superior to trastuzumab plus chemotherapy alone).||0.94|0.67|0.0040
70880920|NCT03615326|141246974|SUPERIORITY|The difference in percentage and its 95% confidence interval (CI) were estimated using the Miettinen \& Nurminen method stratified by geographic region, PD-L1 status (positive vs. negative) at baseline, and chemotherapy regimen (FP or CAPOX).|Difference in Percentage|12.6||||0.0002|TWO_SIDED|95.0|5.6|19.4||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen Method|||ORR in all participants of the Global Pembrolizumab + SOC First Course was compared to PFS in all participants of the Global Standard of Care to address the hypothesis (pembrolizumab in combination with trastuzumab plus chemotherapy is superior to trastuzumab plus chemotherapy alone).||19.4|5.6|0.00020
70880921|NCT02211131|141247036|OTHER||Hazard Ratio (HR)|0.75||||0.07|TWO_SIDED|80.0|0.58|0.96||Unstratified log-rank test|Log Rank||Unstratified Hazard Ratio (T-VEC + Surgery / Surgery)|||0.96|0.58|0.070
70880922|NCT02211131|141247037|OTHER||Hazard Ratio (HR)|0.76||||0.092|TWO_SIDED|80.0|0.6|0.97||Unstratified log-rank test|Log Rank||Unstratified Hazard Ratio (T-VEC + Surgery / Surgery)|||0.97|0.60|0.092
70880923|NCT02211131|141247039|OTHER||Treatment Difference|4.3||||0.594|TWO_SIDED|80.0|-6.9|15.3||The two-sided p-value is based on the Pearson's Chi-square test.|Chi-squared||An 80% approximate exact CI for between-arm differences in binary rate is calculated using Wilson's score method with continuity correction.|||15.3|-6.9|0.594
70880924|NCT02211131|141247040|OTHER||Treatment Difference|14.4||||0.003|TWO_SIDED|80.0|7.4|21.6||The two-sided p-value is based on the Pearson's Chi-square test.|Chi-squared||80% exact CI for binary rate of each arm is calculated using the Clopper Pearson method.|||21.6|7.4|0.003
70880925|NCT02211131|141247045|OTHER||Hazard Ratio (HR)|0.54||||0.05|TWO_SIDED|80.0|0.36|0.81||Unstratified log-rank test|Log Rank||Unstratified Hazard Ratio (T-VEC + Surgery / Surgery)|||0.81|0.36|0.050
70880926|NCT02120950|141247051|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.7||||0.548|TWO_SIDED|95.0|-2.9|1.6|||ANCOVA|||||1.6|-2.9|0.5480
70880927|NCT02120950|141247052|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|0.6||||0.7402|TWO_SIDED|95.0|-3.1|4.3|||Cochran-Mantel-Haenszel|||||4.3|-3.1|0.7402
70880928|NCT02120950|141247054|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.1||||0.0682|TWO_SIDED|95.0|0.0|0.2|||ANCOVA||Point estimate, 95% CI and p-value are based on treatment difference (AFL-sham - AFL-PDT) of the LS mean changes using an ANOVA model with treatment group and ethnicity and qualification for rescue therapy at Week 12 as fixed effects.|||0.2|0.0|0.0682
70880929|NCT02120950|141247055|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.1||||0.164|TWO_SIDED|95.0|-0.1|0.3|||ANCOVA||Point estimate, 95% CI and p-value are based on treatment difference (AFL-sham - AFL-PDT) of the LS mean changes using an ANOVA model with treatment group and ethnicity and qualification for rescue therapy at Week 12 as fixed effects.|||0.3|-0.1|0.1640
70880930|NCT02120950|141247058|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|-5.6||||0.2348|TWO_SIDED|95.0|-14.9|3.7|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Gained ≥ 5||3.7|-14.9|0.2348
70880931|NCT02120950|141247058|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|-2.2||||0.6877|TWO_SIDED|95.0|-13.1|8.6|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Gained ≥ 10||8.6|-13.1|0.6877
70880932|NCT02120950|141247058|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|-4.0||||0.4556|TWO_SIDED|95.0|-14.5|6.5|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Gained ≥ 15||6.5|-14.5|0.4556
70880933|NCT02120950|141247059|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|1.7||||0.5372|TWO_SIDED|95.0|-3.7|7.2|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Lost ≥ 5||7.2|-3.7|0.5372
70880934|NCT02120950|141247059|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|0.6||||0.7569|TWO_SIDED|95.0|-3.4|4.7|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Lost ≥ 10||4.7|-3.4|0.7569
70880935|NCT02120950|141247059|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|-0.6||||0.7402|TWO_SIDED|95.0|-4.3|3.1|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Lost ≥ 15||3.1|-4.3|0.7402
70961091|NCT02382016|141426900|SUPERIORITY||Least squares (LS) mean difference|-5.99||||0.0001|TWO_SIDED|95.0|-8.4|-3.57||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in mPAP (LS mean difference macitentan 10 mg - placebo).|||-3.57|-8.40|0.0001
70961092|NCT02382016|141426901|SUPERIORITY||Least squares (LS) mean difference|0.52||||0.0009|TWO_SIDED|95.0|0.22|0.81||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in cardiac index (LS mean difference macitentan 10 mg - placebo).|||0.81|0.22|0.0009
70961093|NCT02382016|141426902|SUPERIORITY||Least squares (LS) mean difference|-171.48||||0.0001|TWO_SIDED|95.0|-223.67|-119.3||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in TPR (LS mean difference macitentan 10 mg - placebo).|||-119.30|-223.67|0.0001
70961094|NCT02382016|141426903|SUPERIORITY||Least squares (LS) mean difference|0.03||||0.9844|TWO_SIDED|95.0|-2.85|2.91||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in SVO2 (LS mean difference macitentan 10 mg - placebo).|||2.91|-2.85|0.9844
70961095|NCT00084266|141426904|NON_INFERIORITY_OR_EQUIVALENCE|The final p-value was compared against an O'Brien-Fleming boundary of 0.048.||||||0.042|TWO_SIDED||||||Chi-squared|||"Chi-squared test was used to calculate p-value. P-value was calculated for participants with clinical outcome as cure."||||0.042
70961096|NCT00084266|141426916|SUPERIORITY_OR_OTHER|||||||0.9344|TWO_SIDED||||||Log Rank|||Statistical comparison of survival analysis was performed.Log rank method was used to calculate p-value.||||0.9344
70961097|NCT00084266|141426917|SUPERIORITY_OR_OTHER|||||||0.5985|TWO_SIDED||||||Log Rank|||Statistical comparison of survival analysis was performed.Log rank method was used to calculate p-value.||||0.5985
70961098|NCT00084266|141426918|SUPERIORITY_OR_OTHER|||||||0.859|TWO_SIDED||||||Log Rank|||Statistical comparison of survival analysis was performed.Log rank method was used to calculate p-value.||||0.8590
70961099|NCT00655863|141426927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-307.229|||<|0.001|TWO_SIDED|95.0|-443.168|-171.29||p-value and confidence interval presented without multiplicity adjustment.|ANCOVA|||The null hypothesis that there was no difference between Alogliptin 25 mg QD and placebo groups was tested at a 2-sided 0.05 significance level. The ANCOVA model used for the change in postprandial incremental area the curver for total triglycerides includes treatment and statin use as fixed effects and baseline AUC(0-8h) for total triglycerides as a covariate.||-171.290|-443.168|<0.001
70961100|NCT00655863|141426927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-253.711|||<|0.001||95.0|-394.161|-113.262||p-value and confidence interval presented without multiplicity adjustment.|ANCOVA|||The null hypothesis that there was no difference between Alogliptin 25 mg QD + Pioglitazone 30 mg QD and placebo QD groups was tested at a 2-sided 0.05 significance level. The ANCOVA model used for the change in postprandial incremental area the curve for total triglycerides includes treatment and statin use as fixed effects and baseline AUC(0-8h) for total triglycerides as a covariate.||-113.262|-394.161|<0.001
70961101|NCT03588728|141427006|SUPERIORITY|||||||0.781|||||||ANOVA|P value indicates the interaction term.||Test of between-subjects effects||||.781
70961102|NCT03588728|141427007|SUPERIORITY|||||||0.409|||||||ANOVA|P value indicates the interaction term.||Test of between-subjects effects||||.409
70961103|NCT03588728|141427008|SUPERIORITY|||||||0.697|||||||ANOVA|P value indicates the interaction term.||Test of between-subjects effects||||.697
70961104|NCT03588728|141427009|SUPERIORITY|||||||0.193|||||||ANOVA|P value indicates interaction term.||Test of between subjects effects||||.193
70961105|NCT03588728|141427010|SUPERIORITY|||||||0.185|||||||ANOVA|P value indicates the interaction term||Test of between-subjects effects||||.185
70961106|NCT03588728|141427011|SUPERIORITY|||||||0.198|||||||ANOVA|P value indicates the interaction term||Test of between-measures effects||||.198
70961107|NCT03588728|141427012|SUPERIORITY|||||||0.638|||||||ANOVA|||Test of between-subjects effects||||.638
70961108|NCT03588728|141427013|SUPERIORITY|||||||0.574|||||||ANOVA|p-value indicates the interaction term||Test of between-subjects effectd||||.574
70961109|NCT03588728|141427014|SUPERIORITY|||||||0.564|||||||ANOVA|P-value indicates the interaction term||Test of between-subjects effects||||.564
70961110|NCT03588728|141427015|SUPERIORITY|||||||0.998|||||||ANOVA|p-value indicates the interaction term||Tests of between-subjects effects||||.998
70961111|NCT03588728|141427016|SUPERIORITY|||||||0.348|||||||ANOVA|P-value indicates the interaction term||Tests of between-subjecs effects||||.348
70961112|NCT01128894|141427023|NON_INFERIORITY_OR_EQUIVALENCE|The p-value was from a 1-sided t test testing whether or not the difference of least square means (albiglutide - liraglutide) was less than or equal to the prespecified noninferiority margin of 0.3%.|Mean Difference (Final Values)|0.21||||0.0846|TWO_SIDED|95.0|0.08|0.34|||ANCOVA|||||0.34|0.08|0.0846
70961113|NCT00195507|141427030|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53|||<|0.001||95.0|-0.64|-0.43|||ANCOVA|Treatment and center as main effects, and baseline score as a covariant.||||-0.43|-0.64|<0.001
70961114|NCT00195507|141427031|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
70961115|NCT00195507|141427033|SUPERIORITY_OR_OTHER|||||||0.143|||||||Fisher Exact|||||||0.143
70961116|NCT00973362|141427034|SUPERIORITY_OR_OTHER||Sensitivity (%)|75.0|||||TWO_SIDED|95.0|53.1|88.8||||||||88.8|53.1|
70961117|NCT00973362|141427034|SUPERIORITY_OR_OTHER||Specificity (%)|62.6|||||TWO_SIDED|95.0|59.2|65.9||||||||65.9|59.2|
70961118|NCT00973362|141427034|SUPERIORITY_OR_OTHER||Positive Predictive Value [PPV] (%)|4.8|||||TWO_SIDED|95.0|3.4|5.8||||||||5.8|3.4|
70961119|NCT00973362|141427034|SUPERIORITY_OR_OTHER||Negative Predictive Value [NPV] (%)|99.0|||||TWO_SIDED|95.0|98.1|99.6||||||||99.6|98.1|
70961120|NCT00973362|141427034|SUPERIORITY_OR_OTHER||Prevalence (%)|2.4|||||TWO_SIDED|||||||||||||
70961121|NCT00973362|141427034|SUPERIORITY_OR_OTHER||Relative Risk|4.8|||||TWO_SIDED|95.0|1.8|13.1|||||The relative risk of CIN2+ is defined as the \[ absolute risk of APTIMA HPV (Positive Result) / absolute risk of APTIMA HPV (Negative Result) \] .|||13.1|1.8|
70961122|NCT00973362|141427035|SUPERIORITY_OR_OTHER||Sensitivity (%)|84.2|||||TWO_SIDED|95.0|62.4|94.5||||||||94.5|62.4|
70961123|NCT00973362|141427035|SUPERIORITY_OR_OTHER||Specificity (%)|48.7|||||TWO_SIDED|95.0|45.2|52.2||||||||52.2|45.2|
70961124|NCT00973362|141427035|SUPERIORITY_OR_OTHER||Positive Predictive Value [PPV] (%)|3.8|||||TWO_SIDED|95.0|2.9|4.4||||||||4.4|2.9|
70961125|NCT00973362|141427035|SUPERIORITY_OR_OTHER||Negative Predictive Value [NPV] (%)|99.2|||||TWO_SIDED|95.0|98.1|99.8||||||||99.8|98.1|
70961126|NCT00973362|141427035|SUPERIORITY_OR_OTHER||Prevalence (%)|2.4|||||TWO_SIDED|||||||||||||
70961127|NCT00973362|141427035|SUPERIORITY_OR_OTHER||Relative Risk|4.9|||||TWO_SIDED|95.0|1.4|16.7|||||The relative risk of CIN2+ is defined as the \[ absolute risk of FDA-Approved HPV DNA Assay (Positive Result) / absolute risk of FDA-Approved HPV DNA Assay (Negative Result) \] .|||16.7|1.4|
70961128|NCT00973362|141427036|SUPERIORITY_OR_OTHER||Sensitivity(%)|86.8|||||TWO_SIDED|95.0|78.4|92.3||||||||92.3|78.4|
70961129|NCT00973362|141427036|SUPERIORITY_OR_OTHER||Specificty|62.9|||||TWO_SIDED|95.0|59.6|66.0||||||||66.0|59.6|
70961130|NCT00973362|141427036|SUPERIORITY_OR_OTHER||PPV|20.1|||||TWO_SIDED|95.0|18.1|22.0||||||||22.0|18.1|
70961131|NCT00973362|141427036|SUPERIORITY_OR_OTHER||NPV|97.8|||||TWO_SIDED|95.0|96.5|98.8||||||||98.8|96.5|
70961132|NCT00973362|141427036|SUPERIORITY_OR_OTHER||Prevalence (%)|9.7|||||TWO_SIDED|||||||||||||
70961133|NCT00973362|141427037|SUPERIORITY_OR_OTHER||Sensitivity (%)|88.8|||||TWO_SIDED|95.0|80.5|93.8||||||||93.8|80.5|
70961134|NCT00973362|141427037|SUPERIORITY_OR_OTHER||Specificity(%)|55.8|||||TWO_SIDED|95.0|52.3|59.3||||||||59.3|52.3|
70961135|NCT00973362|141427037|SUPERIORITY_OR_OTHER||PPV(%)|18.7|||||TWO_SIDED|95.0|17.0|20.4||||||||20.4|17.0|
70961136|NCT00973362|141427037|SUPERIORITY_OR_OTHER||NPV(%)|97.7|||||TWO_SIDED|95.0|96.2|98.8||||||||98.8|96.2|
70961137|NCT00973362|141427037|SUPERIORITY_OR_OTHER||Prevalence(%)|10.3|||||TWO_SIDED|||||||||||||
70961138|NCT01630434|141427050|NON_INFERIORITY|The non-inferiority margin, which is here taken to be 0.04.|difference of proportion|-0.091||||0.004|ONE_SIDED|95.0||-0.01|||Wald Method|||||-0.01||0.004
70961139|NCT01630434|141427050|NON_INFERIORITY|The non-inferiority margin, which is here taken to be 0.04.|difference of proportion|-0.038||||0.06|ONE_SIDED|95.0||0.045|||Wald Method|||||0.045||0.06
70961140|NCT01630434|141427051|NON_INFERIORITY|The non-inferiority margin is 5%.|Difference of proportions|-0.015||||0.0003|ONE_SIDED|95.0||0.016|||Wald Method|||||0.016||0.0003
70961141|NCT01630434|141427051|NON_INFERIORITY|The non-inferiority margin is 5%.|Difference of proportions|0.006||||0.027|ONE_SIDED|95.0||0.044|||Wald Method|||||0.044||0.027
70961142|NCT01630434|141427052|NON_INFERIORITY|The non-inferiority margin is 7.5%.|Difference of proportions|0.035||||0.118|ONE_SIDED|95.0||0.091|||Wald Method|||||0.091||0.118
70961143|NCT01630434|141427052|NON_INFERIORITY|The non-inferiority margin is 7.5%.|Difference of proportions|0.065||||0.389|ONE_SIDED|95.0||0.124|||Wald Method|||||0.124||0.389
70961144|NCT01630434|141427053|NON_INFERIORITY|The non-inferiority margin is 4%|Difference of proportions|0.043|||||ONE_SIDED|95.0||0.071||||||||0.071||
70961145|NCT01630434|141427053|NON_INFERIORITY|The non-inferiority margin is 4%.|Difference of proportions|0.054|||||ONE_SIDED|95.0||0.087||||||||0.087||
70961146|NCT01630434|141427054|NON_INFERIORITY|The non-inferiority margin is 0.7.|Mean Difference (Final Values)|-0.045|||<|0.0001|ONE_SIDED|95.0||0.047|||t-test, 2 sided|||||0.047||<0.0001
70961147|NCT01592864|141427117|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.2||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a negative difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||-0.2|-0.6|<0.0001
70961148|NCT01592864|141427118|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.3||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a negative difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||-0.3|-0.6|<0.0001
70961149|NCT01592864|141427119|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|16.9|||<|0.0001|TWO_SIDED|95.0|11.1|22.8||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a positive difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||22.8|11.1|<0.0001
70961150|NCT01592864|141427120|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.6|||<|0.0001|TWO_SIDED|95.0|5.4|13.9||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a positive difference favors first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||13.9|5.4|<0.0001
70961151|NCT02120716|141427122|OTHER|Logistic regression analysis.|Odds Ratio (OR)|5.5||||0.13|TWO_SIDED|95.0|0.6|51.2|||Regression, Logistic|||||51.2|0.6|0.13
70961152|NCT02120716|141427123|SUPERIORITY||Odds Ratio (OR)|11.7|||<|0.015|TWO_SIDED|95.0|4.2|33.0|||Regression, Logistic|||The reported percentages were captured at two separate time points (baseline, and at 4-Month Follow-Up).||33.0|4.2|<0.015
70961153|NCT02858349|141427124|SUPERIORITY||Mean Difference (Net)|0.13||||0.0042|TWO_SIDED|95.0|0.05|0.21|||Mixed Models Analysis|||||0.21|0.05|0.0042
70961154|NCT01881750|141427136|SUPERIORITY_OR_OTHER|||||||0.42|||||||Mixed Effects Regression Model|||Group X Time Interaction Cohen's d||||0.42
70961155|NCT04668586|141427145|SUPERIORITY||||||<|0.006|||||||Chi-squared|||||||<0.006
70961156|NCT04668586|141427146|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|Adjusted for four-category stratification group.||||||0.008
70961157|NCT04668586|141427148|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
70961158|NCT04668586|141427149|SUPERIORITY|||||||0.09|||||||Chi-squared, Corrected|Adjusted for four-category stratification group.||||||0.09
70961159|NCT01106404|141427151|SUPERIORITY_OR_OTHER||binomial proportion|0.865|||<|0.001|ONE_SIDED|97.5|0.765||||Fisher Exact||In this ITT analysis, the combined percentage of subjects with improved pain relief and/or convenience during the AdaptiveStim programming relative to the manual programming in both groups was reported.|"ITT analysis:~Hypothesis: The percentage of subjects who succeed must be greater than 25%. H0: p ≤ 0.25 HA: p \> 0.25"|||0.765|< 0.001
70880936|NCT02120950|141247060|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|-6.0||||0.3244|TWO_SIDED|95.0|-17.8|5.9|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|||5.9|-17.8|0.3244
70880937|NCT02120950|141247061|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.1||||0.7109|TWO_SIDED|95.0|-0.9|0.6|||ANCOVA||Point estimate, 95% CI and p-value are based on difference (AFL-sham - AFL-PDT) of LS mean changes using an ANCOVA model with treatment group and ethnicity and qualification for rescue therapy at Week 12 as fixed effects, baseline value as covariate.|The analysis population included only subjects with leakage in FA at baseline and Week 52. Baseline values were not carried forward.||0.6|-0.9|0.7109
70880938|NCT02120950|141247062|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.1||||0.8355|TWO_SIDED|95.0|-9.2|11.3|||ANCOVA||Point estimate, 95% CI and p-value are based on difference (AFL-sham - AFL-PDT) of LS mean changes using an ANCOVA model with treatment group and ethnicity and qualification for rescue therapy at Week 12 as fixed effects, baseline value as covariate.|The analysis population included only subjects with values for CST at baseline and Week 52. Baseline values were not carried forward.||11.3|-9.2|0.8355
70880939|NCT02120950|141247063|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.7||||0.5069|TWO_SIDED|95.0|-2.9|1.4|||ANCOVA||Point estimate, 95% CI and p-value are based on difference (AFL-sham - AFL-PDT) of LS mean changes using an ANCOVA model with treatment group and ethnicity and qualification for rescue therapy at Week 12 as fixed effects, baseline value as covariate.|The analysis population included only subjects with values for NEI VFQ-25 score at baseline and Week 52.||1.4|-2.9|0.5069
70880940|NCT02120950|141247064|SUPERIORITY_OR_OTHER_LEGACY||Difference %|-0.6||||0.8423|TWO_SIDED|95.0|-6.3|5.1||The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12.|Cochran-Mantel-Haenszel||CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12.|||5.1|-6.3|0.8423
70880941|NCT02424383|141247065|OTHER||||||||||||||||||Freedom from Target LesionRevascularization (TLR) were reported through 12 months with frequency counts, percentages and 95% confidence intervals from exact binomial test. In addition, Kaplan-Meier tables and curves were created.|||
70880942|NCT02424383|141247066|OTHER||||||||||||||||||Freedom from composite of safety events from the time following the index procedure through 30 days post procedure were reported with frequency counts, percentages and 95% confidence intervals from exact binomial test. Kaplan-Meier tables and curves were also calculated.|||
70880943|NCT01549964|141247089|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.108|<|0.001|TWO_SIDED|95.0|-0.77|-0.34||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-0.34|-0.77|<0.001
70880944|NCT01549964|141247089|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.087|<|0.001|TWO_SIDED|95.0|0.15|0.49||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||0.49|0.15|<0.001
70880945|NCT01549964|141247089|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.109|<|0.001|TWO_SIDED|95.0|-1.03|-0.6||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-0.60|-1.03|<0.001
70880946|NCT01549964|141247089|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.087||0.524|TWO_SIDED|95.0|-0.12|0.23||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||0.23|-0.12|0.524
70880947|NCT01549964|141247090|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.25||||0.05|TWO_SIDED|95.0|1.0|5.08||P-Value was obtained from a logistic model with treatment, schedule, baseline HbA1c as explanatory variables.|Regression, Logistic|||||5.08|1.00|0.050
70880948|NCT01549964|141247090|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.39|||<|0.001|TWO_SIDED|95.0|0.23|0.67||P-Value was obtained from a logistic model with treatment, schedule, baseline HbA1c as explanatory variables.|Regression, Logistic|||||0.67|0.23|<0.001
70880949|NCT01549964|141247090|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.06|||<|0.001|TWO_SIDED|95.0|2.24|11.42||P-Value was obtained from a logistic model with treatment, schedule, baseline HbA1c as explanatory variables.|Regression, Logistic|||||11.42|2.24|<0.001
70880950|NCT01549964|141247090|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.493|TWO_SIDED|95.0|0.5|1.39||P-Value was obtained from a logistic model with treatment, schedule, baseline HbA1c as explanatory variables.|Regression, Logistic|||||1.39|0.50|0.493
70880951|NCT01549964|141247091|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.2|STANDARD_ERROR_OF_MEAN|4.36|<|0.001|TWO_SIDED|95.0|-33.8|-16.6||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-16.6|-33.8|<0.001
70880952|NCT01549964|141247091|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|3.49||0.142|TWO_SIDED|95.0|-12.0|1.7||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||1.7|-12.0|0.142
70880953|NCT01549964|141247091|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.3|STANDARD_ERROR_OF_MEAN|4.4|<|0.001|TWO_SIDED|95.0|-39.9|-22.6||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-22.6|-39.9|<0.001
70961160|NCT01106404|141427151|SUPERIORITY_OR_OTHER||binomial proportion|0.901|||<|0.001|ONE_SIDED|97.5|0.807||||Fisher Exact||In this completed case analysis, the combined percentage of subjects with improved pain relief and/or convenience during the AdaptiveStim programming relative to the manual programming in both groups was reported.|Completed case analysis|||0.807|< 0.001
70961161|NCT01106404|141427152|SUPERIORITY_OR_OTHER||binomial proportion|0.028|||||TWO_SIDED|95.0|0.003|0.098|||||The combined percentage of subjects with worsened pain relief was reported.|||0.098|0.003|
70961162|NCT01106404|141427153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.8|STANDARD_DEVIATION|51.9|<|0.001||95.0|||||Wilcoxon signed rank test|||||||< 0.001
70961163|NCT01106404|141427154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.77|STANDARD_DEVIATION|1.93|<|0.001||95.0|||||Wilcoxon signed rank test|||||||< 0.001
70961164|NCT01106404|141427154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|STANDARD_DEVIATION|2.04|<|0.001|TWO_SIDED|95.0|||||Wilcoxon signed rank test|||||||< 0.001
70961165|NCT03552822|141427167|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
70961166|NCT03552822|141427168|SUPERIORITY|||||||0.037|||||||Wilcoxon (Mann-Whitney)|||||||0.037
70961167|NCT03552822|141427169|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
70961168|NCT03552822|141427170|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
70961169|NCT03552822|141427171|SUPERIORITY|||||||0.108|||||||Wilcoxon (Mann-Whitney)|||||||0.108
70961170|NCT03552822|141427172|SUPERIORITY|||||||0.159|||||||Fisher Exact|||||||0.159
70961171|NCT03552822|141427173|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
70961172|NCT03552822|141427174|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
70961173|NCT03552822|141427175|SUPERIORITY|||||||0.085|||||||Wilcoxon (Mann-Whitney)|||||||0.085
70961174|NCT00954421|141427234|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.6|STANDARD_DEVIATION|19.4||0.026|TWO_SIDED|95.0|-30.61|-4.65|||two-sided sign-rank test||p-value assessed via sign-rank test (pre-planned method)|The null hypothesis is that the mean change in Tremor Rating Scale score from baseline to six months post-implant (with VIM and VO stimulators turned ON) will be zero||-4.65|-30.61|.026
70961175|NCT00954421|141427235|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.4|STANDARD_DEVIATION|9.1||0.011|TWO_SIDED|95.0|2.2|14.5||Sign rank test was pre-planned for P-value|Sign-Rank test||p-value assessed using sign rank test|The null hypothesis is that difference in change in Tremor Rating Scale (TRS) score from baseline to 6 months when both stimulators are on (VIM and VO), versus when both stimulators are off, will be zero (i.e., that there will be no difference in effect between having both stimulators on versus both stimulators off)||14.5|2.2|0.011
70961176|NCT00954421|141427235|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.73|STANDARD_DEVIATION|8.49||0.68||95.0|-4.96|6.42|||two-sided sign rank test|two sided sign rank test as pre-planned||The null hypothesis is that difference in change in Tremor Rating Scale (TRS) score from baseline to 6 months when VO is on and VIM is off, versus when VIM is on and VO is off, will be zero (i.e., that there will be no difference in effect between having exclusively VIM versus VO on)||6.42|-4.96|.68
70961177|NCT05245097|141427238|OTHER|For the multiple imputation, a total of 50 imputed datasets will be calculated (Graham et al.). Fully conditional specification (FCS) discriminant function method will be used to impute missing primary endpoint using the baseline covariates of age, sex, race, ethnicity, mobility level, and BIMS Score. The FCS logistic method was replaced with the FCS discriminant function method due to a quasi-separation caused by only one observed primary endpoint event in the treatment group.||||||0.004||||||The null hypothesis was tested at a one-sided 0.025 level of significance using a logistic regression analysis to compare treatment groups while controlling for propensity score.|Regression, Logistic|||||||0.004
70961178|NCT05245097|141427239|OTHER|||||||0.003||||||The hip fracture due to fall rate was compared between treatment groups using firth logistic regression while controlling for propensity score. A one-sided 0.025 level of significance was used.|Regression, Logistic|||||||0.003
70961179|NCT05245097|141427239|SUPERIORITY|||||||0.003|||||||Regression, Logistic|||||||0.003
70961180|NCT05245097|141427240|SUPERIORITY|||||||0.001||||||The emergency department visit due to fall rate was compared between treatment groups using firth logistic regression while controlling for propensity score. A one-sided 0.025 level of significance was used.|Regression, Logistic|Subjects with multiple ED visits due to falls are only counted once.||||||0.001
70961181|NCT05245097|141427241|SUPERIORITY|||||||0.003||||||The hospitalization due to fall rate was compared between treatment groups using firth logistic regression while controlling for propensity score. A one-sided 0.025 level of significance was used.|Regression, Logistic|Subjects with multiple hospitalizations due to falls are only counted once.||||||0.003
70961182|NCT00692978|141427265|EQUIVALENCE|Log transformed parametric ANOVA|||||<|0.05||||||calculated|ANOVA|||||||<0.05
70961183|NCT00607022|141427266|OTHER|Kruskal-Wallis values between each loading group and for Wilcoxon Signed Rank for measures on the mesial vs buccal side of the implant.|||||>|0.05||||||0.0501 \< p \< 0.9797|Kruskal-Wallis|Kruskal-Wallis test evaluated ISQ at each time point..||Comparison between loading groups at 16 weeks - loading at baseline, Loading at 6 weeks, and loading at 12 weeks. Scores for all groups were compared at 16 weeks from implant placement..||||>0.05
70961184|NCT01005459|141427267|OTHER|unpaired t-test|||||>|0.05|||||||unpaired t-test compared between groups|||||||>0.05
70961185|NCT01005459|141427267|OTHER|unpaired t-test compared between groups|||||>|0.05|||||||unpaired t-test compared between groups|||||||>0.05
70961186|NCT03254485|141427269|SUPERIORITY||Least Squares Mean Difference|-0.3|||=|0.3681|TWO_SIDED|95.0|-0.95|0.35|||ANCOVA|||||0.35|-0.95|=0.3681
70961187|NCT03254485|141427270|SUPERIORITY||Least Squares Mean Difference|-16.74|||=|0.2817|TWO_SIDED|95.0|-47.38|13.9|||ANCOVA|||||13.90|-47.38|=0.2817
70961188|NCT03254485|141427271|SUPERIORITY||Least Squares Mean Difference|-0.297|||=|0.6508|TWO_SIDED|95.0|-1.591|0.997|||ANCOVA|||||0.997|-1.591|=0.6508
70880954|NCT01549964|141247091|SUPERIORITY_OR_OTHER||Least Square Mean difference|-11.2|STANDARD_ERROR_OF_MEAN|3.53||0.002|TWO_SIDED|95.0|-18.1|-4.2||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-4.2|-18.1|0.002
70880955|NCT01154218|141247095|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|99.56|||||TWO_SIDED|90.0|91.49|108.33||||||Natural log transformed AUC (0-∞) of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||108.33|91.49|
70880956|NCT01154218|141247095|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|106.93|||||TWO_SIDED|90.0|98.26|116.35||||||Natural log transformed AUC (0-∞) of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||116.35|98.26|
70880957|NCT01154218|141247095|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|85.76|||||TWO_SIDED|90.0|78.88|93.25||||||Natural log transformed AUC (0-∞) of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||93.25|78.88|
70880958|NCT01154218|141247096|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|99.6|||||TWO_SIDED|90.0|91.3|108.66||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||108.66|91.30|
70880959|NCT01154218|141247096|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|107.56|||||TWO_SIDED|90.0|98.58|117.35||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||117.35|98.58|
70880960|NCT01154218|141247096|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|85.52|||||TWO_SIDED|90.0|78.45|93.22||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||93.22|78.45|
70880961|NCT01154218|141247099|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|106.97|||||TWO_SIDED|90.0|96.55|118.51||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||118.51|96.55|
70880962|NCT01154218|141247099|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|111.32|||||TWO_SIDED|90.0|100.47|123.33||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||123.33|100.47|
70880963|NCT01154218|141247099|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|86.22|||||TWO_SIDED|90.0|77.89|95.43||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||95.43|77.89|
70880964|NCT01154218|141247102|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|100.03|||||TWO_SIDED|90.0|90.16|110.97||||||Natural log transformed AUClast of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||110.97|90.16|
70880965|NCT01154218|141247102|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|108.85|||||TWO_SIDED|90.0|98.11|120.77||||||Natural log transformed AUClast of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||120.77|98.11|
70961189|NCT00467285|141427273|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||comparison of changes in BMD at 6months compared to baseline||||<0.05
70961190|NCT01658826|141427371|SUPERIORITY||Risk Ratio (RR)|0.43|||<|0.0001|TWO_SIDED|95.0|0.3|0.63|||non-linear mixed effects model|||||0.63|0.30|<0.0001
70880966|NCT01154218|141247102|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|74.87|||||TWO_SIDED|90.0|67.55|82.98||||||Natural log transformed AUClast of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||82.98|67.55|
70880967|NCT01154218|141247103|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|100.08|||||TWO_SIDED|90.0|90.46|110.73||||||Natural log transformed AUC (0-∞) of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||110.73|90.46|
70880968|NCT01154218|141247103|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|108.47|||||TWO_SIDED|90.0|98.03|120.02||||||Natural log transformed AUC (0-∞) of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||120.02|98.03|
70880969|NCT01154218|141247103|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|76.59|||||TWO_SIDED|90.0|69.23|84.74||||||Natural log transformed AUC (0-∞) of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||84.74|69.23|
70880970|NCT01154218|141247104|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|102.11|||||TWO_SIDED|90.0|92.84|112.31||||||Natural log transformed Cmax of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||112.31|92.84|
70880971|NCT01154218|141247104|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|108.87|||||TWO_SIDED|90.0|98.98|119.75||||||Natural log transformed Cmax of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||119.75|98.98|
70961191|NCT01598311|141427385|NON_INFERIORITY|Non-inferiority was declared when the lower bound of the 95% CI for the difference in adjusted percentage of cured subjects was \> -10%.|Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-4.9|7.6||||||||7.6|-4.9|
70961192|NCT01598311|141427387|SUPERIORITY|Superiority was declared if the lower bound of the 95% CI of the adjusted difference in sustained response was \> 0.|Mean Difference (Final Values)|4.3|||||TWO_SIDED|95.0|-3.6|12.2||||||||12.2|-3.6|
70961193|NCT03602261|141427409|OTHER|||||||0.5536|||||||Fisher Exact|||||||0.5536
70961194|NCT03081052|141427431|EQUIVALENCE|We estimated sample size based on equivalence test of the incidence rates of a binary outcome (e.g. PGD grade 3 (PGD-3)) of two treatment groups as an illustration. Assuming the incidence rate of PGD-3 under iEPO treatment is 0.30 and acceptable margin of the equivalence is ± 0.19, we will need 200 lung transplant patients to have 80% power to detect an actual difference at α=0.05 between two treatment group under this margin.|Risk Difference (RD)|0.049||||0.019|TWO_SIDED|90.0|-0.064|0.162|||two one sided test p-value|||||0.162|-0.064|0.019
70961195|NCT03081052|141427432|NON_INFERIORITY|We estimated sample size based on equivalence test of the incidence rates of a binary outcome of two treatment groups as an illustration. Assuming the incidence rate of moderate or severe RV failure under iEPO treatment is 0.113 and acceptable margin of the equivalence is ± 0.15, we will need 224 heart failure patients to have 80% power to detect an actual difference at α=0.05 between two treatment group under this margin.|Risk Difference (RD)|0.025||||0.012|TWO_SIDED|90.0|-0.066|0.116|||two one-sided test p-value|||||0.116|-0.066|0.012
70961196|NCT03081052|141427433|OTHER||Hodges-Lehmann Location Shift|0.0||||0.747|TWO_SIDED|95.0|-3.0|3.0|||Log Rank|||||3|-3|0.747
70961197|NCT03081052|141427433|OTHER||Hodges-Lehmann Location Shift|0.0||||0.638|TWO_SIDED|95.0|-1.0|1.0|||Log Rank|||||1|-1|0.638
70961198|NCT03081052|141427435|OTHER||mean ratio|1.19||||0.453|TWO_SIDED|95.0|0.76|1.87|||log-linear regression|||||1.87|0.76|0.453
70961199|NCT03081052|141427435|OTHER||mean ratio|0.94||||0.816|TWO_SIDED|95.0|0.57|1.56|||log-linear regression|||||1.56|0.57|0.816
70961200|NCT03081052|141427436|OTHER||mean ratio|1.03||||0.864|TWO_SIDED|95.0|0.75|1.41|||log-linear regression|||||1.41|0.75|0.864
70961201|NCT03081052|141427436|OTHER||mean ratio|0.97||||0.825|TWO_SIDED|95.0|0.73|1.28|||log-linear regression|||||1.28|0.73|0.825
70961202|NCT03081052|141427437|OTHER||Odds Ratio (OR)|1.43||||0.251|TWO_SIDED|95.0|0.78|2.61|||Chi-squared|||||2.61|0.78|0.251
70961203|NCT03081052|141427437|OTHER||Odds Ratio (OR)|1.2||||0.619|TWO_SIDED|95.0|0.58|2.5|||Chi-squared|||||2.5|0.58|0.619
70961204|NCT03081052|141427439|OTHER||Odds Ratio (OR)|2.13||||0.614|TWO_SIDED|95.0|0.19|23.82|||Fisher Exact|||||23.82|0.19|0.614
70961205|NCT03081052|141427439|OTHER||Odds Ratio (OR)|0.6||||0.5424|TWO_SIDED|95.0|0.17|2.12|||Fisher Exact|||||2.12|0.17|0.5424
70961206|NCT00604279|141427452|NON_INFERIORITY_OR_EQUIVALENCE|The predetermined margin for non-inferiority of paliperidone palmitate was 5.5 points|Least Square Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.48||||95.0|-5.2|0.63|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used.||||0.63|-5.20|
70961207|NCT00604279|141427453|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.34||||95.0|-2.14|3.12|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used.||||3.12|-2.14|
70961208|NCT00604279|141427454|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||||95.0|-0.33|0.1|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used.||||0.10|-0.33|
70961209|NCT00604279|141427455|SUPERIORITY_OR_OTHER||Least Square Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|2.08||||95.0|-0.67|7.5|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used.||Statistical Analysis for Quality of sleep||7.50|-0.67|
70961210|NCT00604279|141427455|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.02||||95.0|-5.04|2.9|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used.||Statistical Analysis for Daytime drowsiness||2.90|-5.04|
70961211|NCT00604279|141427456|SUPERIORITY_OR_OTHER||Point estimate of relative risk|0.9||||||95.0|0.81|1.01|||Cochran-Mantel-Haenszel|||||1.01|0.81|
70961212|NCT00719563|141427527|SUPERIORITY_OR_OTHER|||||||0.0737|||||||Wilcoxon Rank Sum|||||||0.0737
70961213|NCT00567268|141427546|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.004|||||||Fisher Exact|||"The risk factor tested was age. The null hypothesis was that there was no association between the age and the number of responders to the treatment with gabapentin."||||=0.004
70961214|NCT00567268|141427547|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.003|||||||Fisher Exact|||"The risk factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across increasing levels of the number of concomitant antiepileptic drugs at baseline."||||=0.003
70961215|NCT00567268|141427547|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.003|||||||Cochran-Armitage|||"The risk factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across increasing levels of the number of concomitant antiepileptic drugs at baseline."||||=0.003
70961216|NCT00567268|141427548|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The factor tested was age. The null hypothesis was that there was no difference between \<65 years and \>=65 years in the number of participants who responded to the treatment with gabapentin."||||<0.001
70961217|NCT00567268|141427549|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The factor tested was age. The null hypothesis was that there was no association between the age and the number of participants who responded to the treatment with gabapentin."||||<0.001
70961218|NCT00567268|141427549|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Armitage|||"The factor tested was age. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across increasing levels of age categories."||||<0.001
70880972|NCT01154218|141247104|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|71.94|||||TWO_SIDED|90.0|65.46|79.05||||||Natural log transformed Cmax of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||79.05|65.46|
70961219|NCT00567268|141427550|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.008|||||||Chi-squared|||"The factor tested was severity of partial epileptic seizure . The null hypothesis was that there was no association between the degree of severity of partial epileptic seizure (mild, moderate, and severe) and the number of participants who responded to the treatment with gabapentin."||||=0.008
70880973|NCT00362115|141247107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9||||0.0631|TWO_SIDED|95.0|-5.96|0.16||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.16|-5.96|0.0631
70880974|NCT00362115|141247107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3||||0.0008|TWO_SIDED|95.0|-8.33|-2.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.20|-8.33|0.0008
70880975|NCT00362115|141247107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7||||0.0188|TWO_SIDED|95.0|-6.73|-0.61||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.61|-6.73|0.0188
70880976|NCT00362115|141247107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.0003|TWO_SIDED|95.0|-8.8|-2.63||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.63|-8.80|0.0003
70880977|NCT00362115|141247107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7||||0.0177|TWO_SIDED|95.0|-6.77|-0.65||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.65|-6.77|0.0177
70880978|NCT00362115|141247107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.855||95.0|-2.72|3.27||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.27|-2.72|0.8550
70880979|NCT00362115|141247107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.1719|TWO_SIDED|95.0|-5.08|0.91||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.91|-5.08|0.1719
70880980|NCT00362115|141247107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.7469|TWO_SIDED|95.0|-3.49|2.5||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.50|-3.49|0.7469
70961220|NCT00567268|141427550|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.002|||||||Cochran-Armitage|||"The factor tested was severity of partial epileptic seizure. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across the degree of severity of partial epileptic seizure (mild, moderate, and severe)."||||=0.002
70961221|NCT00567268|141427551|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.018|||||||Chi-squared|||"The factor tested was baseline frequency of epileptic seizure. The null hypothesis was that there was no difference between the baseline frequency of epileptic seizure and the number of participants who responded to the treatment with gabapentin."||||=0.018
70880981|NCT00362115|141247107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.1001|TWO_SIDED|95.0|-5.55|0.49||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.49|-5.55|0.1001
70880982|NCT00362115|141247107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.7294|TWO_SIDED|95.0|-3.52|2.47||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.47|-3.52|0.7294
70880983|NCT00362115|141247108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||0.0111|TWO_SIDED|95.0|-10.84|-1.41||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.41|-10.84|0.0111
70880984|NCT00362115|141247108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|||<|0.0001|TWO_SIDED|95.0|-15.51|-6.08||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.08|-15.51|< 0.0001
70880985|NCT00362115|141247108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.8|||<|0.0001|TWO_SIDED|95.0|-14.53|-5.1||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.10|-14.53|< 0.0001
70880986|NCT00362115|141247108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.3|||<|0.0001|TWO_SIDED|95.0|-17.02|-7.52||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.52|-17.02|< 0.0001
70880987|NCT00362115|141247108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.5||||0.0005|TWO_SIDED|95.0|-13.19|-3.76||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.76|-13.19|0.0005
70880988|NCT00362115|141247108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.2768|TWO_SIDED|95.0|-2.06|7.17||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||7.17|-2.06|0.2768
70880989|NCT00362115|141247108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.3688|TWO_SIDED|95.0|-6.74|2.51||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.51|-6.74|0.3688
70880990|NCT00362115|141247108|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.1||||0.6293|TWO_SIDED|95.0|-5.75|3.48||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.48|-5.75|0.6293
70880991|NCT00362115|141247108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.1298|TWO_SIDED|95.0|-8.25|1.06||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.06|-8.25|0.1298
70880992|NCT00362115|141247108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.9315|TWO_SIDED|95.0|-4.41|4.82||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.82|-4.41|0.9315
70880993|NCT00362115|141247109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1||||0.0016|TWO_SIDED|95.0|-13.17|-3.09||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.09|-13.17|0.0016
70880994|NCT00362115|141247109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.1|||<|0.0001|TWO_SIDED|95.0|-15.17|-5.09||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.09|-15.17|< 0.0001
70880995|NCT00362115|141247109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.8|||<|0.0001|TWO_SIDED|95.0|-17.8|-7.72||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.72|-17.80|< 0.0001
70880996|NCT00362115|141247109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.3|||<|0.0001|TWO_SIDED|95.0|-16.36|-6.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.20|-16.36|< 0.0001
70880997|NCT00362115|141247109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.7|||<|0.0001|TWO_SIDED|95.0|-15.75|-5.63||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.63|-15.75|< 0.0001
70880998|NCT00362115|141247109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9909|TWO_SIDED|95.0|-4.96|4.91||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.91|-4.96|0.9909
70880999|NCT00362115|141247109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.4213|TWO_SIDED|95.0|-6.96|2.92||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.92|-6.96|0.4213
70881000|NCT00362115|141247109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7||||0.0646|TWO_SIDED|95.0|-9.59|0.28||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.28|-9.59|0.0646
70881001|NCT00362115|141247109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2||||0.2107|TWO_SIDED|95.0|-8.15|1.8||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.80|-8.15|0.2107
70961222|NCT00567268|141427552|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no association between the number of concomitant antiepileptic drugs at baseline and the number of participants who responded to the treatment with gabapentin."||||<0.001
70961223|NCT00567268|141427552|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Armitage|||"The factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across increasing levels of the number of concomitant antiepileptic drugs at baseline."||||<0.001
70961224|NCT00567268|141427553|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.025|||||||Cochran-Armitage|||"The factor tested was baseline creatinine clearance. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across increasing levels of the baseline creatinine clearance."||||=0.025
70961225|NCT00567268|141427554|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.043|||||||Chi-squared|||"The factor tested was non-drug therapy. The null hypothesis was that there was no difference between the non-drug therapy and the number of participants who responded to the treatment with gabapentin."||||=0.043
70961226|NCT00420017|141427555|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.38||||0.02|TWO_SIDED|95.0|0.16|0.86|||Chi-squared|||||0.86|0.16|0.02
70961227|NCT00420017|141427556|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.31
70961228|NCT00420017|141427557|SUPERIORITY_OR_OTHER|||||||0.097||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.097
70961229|NCT00420017|141427558|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||Chi-squared|||||||0.66
70881002|NCT00362115|141247109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.3059|TWO_SIDED|95.0|-7.54|2.37||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.37|-7.54|0.3059
70961230|NCT02952001|141427583|SUPERIORITY|||||||0.562||||||The a priori threshold for statistical significance was 0.050. No adjustments made or required for multiplicity.|Log-rank chi-square test|||The null hypothesis of no difference in the survival time distributions was tested.||||0.562
70961231|NCT04533451|141427590|SUPERIORITY|||||||0.0385|||||||Log Rank|||||||0.0385
70961232|NCT04533451|141427592|EQUIVALENCE|Relatively large sample size and groups are independent.||||||0.9829|||||||Chi-squared|||||||0.9829
70961233|NCT01996813|141427595|SUPERIORITY||Odds Ratio (OR)|0.115||||0.0553|TWO_SIDED|95.0|0.002|1.034||The exact p-value was estimated|Regression, Logistic|The method was exact logistic regression||The null hypothesis is that there is no difference in the odds of a cerebral desaturation event between patients wearing versus not wearing thigh-high compression stockings during shoulder arthroscopy in the beach chair position||1.034|0.002|.0553
70961234|NCT01996813|141427596|SUPERIORITY||Mean Difference (Final Values)|40.31|||<|0.001|TWO_SIDED|95.0|20.22|60.39|||t-test, 2 sided|A Satterthwaite correction was used to adjust the degrees of freedom||The null hypothesis is that there is no difference in the average length of surgery between patients wearing versus not wearing thigh-high compression stockings during shoulder arthroscopy in the beach chair position||60.39|20.22|<.001
70961235|NCT02982187|141427605|SUPERIORITY||Odds Ratio (OR)|29.114|||<|0.001|TWO_SIDED|95.0|11.047||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 1: DISKUS + HandiHaler vs ELLIPTA|||11.047|<0.001
70961236|NCT02982187|141427605|SUPERIORITY||Odds Ratio (OR)|27.744|||<|0.001|TWO_SIDED|95.0|10.512||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|||10.512|<0.001
70961237|NCT02982187|141427606|SUPERIORITY||Odds Ratio (OR)|4.248||||0.029|TWO_SIDED|95.0|1.416||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 1:DISKUS + HandiHaler vs ELLIPTA|||1.416|0.029
70961238|NCT02982187|141427606|SUPERIORITY||Odds Ratio (OR)|3.855||||0.026|TWO_SIDED|95.0|1.394||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|||1.394|0.026
70961239|NCT02982187|141427607|SUPERIORITY||Odds Ratio (OR)|2.0||||0.4|TWO_SIDED|95.0|0.459||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 1:DISKUS + HandiHaler vs ELLIPTA|||0.459|0.400
70961240|NCT02982187|141427607|SUPERIORITY||Odds Ratio (OR)|1.732||||0.5|TWO_SIDED|95.0|0.397||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|||0.397|0.500
70961241|NCT02982187|141427608|SUPERIORITY||Odds Ratio (OR)|24.539|||<|0.001|TWO_SIDED|95.0|9.268||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 1:DISKUS + HandiHaler vs ELLIPTA|||9.268|<0.001
70961242|NCT02982187|141427608|SUPERIORITY||Odds Ratio (OR)|17.974|||<|0.001|TWO_SIDED|95.0|7.239||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|||7.239|<0.001
70961243|NCT02982187|141427609|SUPERIORITY||Odds Ratio (OR)|3.237||||0.067|TWO_SIDED|95.0|1.124||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 1:DISKUS + HandiHaler vs ELLIPTA|||1.124|0.067
70961244|NCT02982187|141427609|SUPERIORITY||Odds Ratio (OR)|6.357||||0.003|TWO_SIDED|95.0|2.219||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|||2.219|0.003
70961245|NCT02982187|141427610|SUPERIORITY||||||||||||||stratified exact logistic model|||Sub study 1: DISKUS + HandiHaler vs ELLIPTA|These statistics were only presented when the model successfully converged. A stratified exact logistic model was used with participant included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|||
70961246|NCT02982187|141427610|SUPERIORITY||Odds Ratio (OR)|1.732||||0.5|TWO_SIDED|95.0|0.397||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|||0.397|0.500
70961247|NCT02982187|141427611|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|This method of analysis does not take sequence of treatment option into account||Sub study 1:DISKUS + HandiHaler vs ELLIPTA||||<0.001
70961248|NCT02982187|141427611|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|This method of analysis does not take sequence of treatment option into account||Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA||||<0.001
70961249|NCT02982187|141427615|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70961250|NCT02982187|141427615|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70961251|NCT02982187|141427616|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70961252|NCT02982187|141427616|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70961253|NCT02604433|141427617|SUPERIORITY||Odds Ratio (OR)|5.62|||<|0.0001|TWO_SIDED|95.0|2.17|14.53||Significance level of 0.050 for 2-sided tests.|Cochran-Mantel-Haenszel|||Odds ratio 95% confidence intervals (CIs), and p-value were estimated from the Cochran Mantel-Haenszel (CMH) test stratified by the geographical regions defined at randomization.||14.53|2.17|<0.0001
70961254|NCT02604433|141427617|SUPERIORITY||Difference in Percentages|16.5|||||TWO_SIDED|95.0|10.0|23.1|||||Luspatercept - Placebo|||23.1|10.0|
70881003|NCT00362115|141247110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.1653|TWO_SIDED|95.0|-5.69|0.98||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.98|-5.69|0.1653
70881004|NCT00362115|141247110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2||||0.0151|TWO_SIDED|95.0|-7.5|-0.81||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.81|-7.50|0.0151
70881005|NCT00362115|141247110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.048|TWO_SIDED|95.0|-6.7|-0.03||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.03|-6.70|0.0480
70961255|NCT02604433|141427617|SUPERIORITY||Common Risk Difference|16.5||||||95.0|9.9|23.1|||||Luspatercept - Placebo|||23.1|9.9|
70961256|NCT02604433|141427618|SUPERIORITY||Odds Ratio (OR)|6.44|||<|0.0001|TWO_SIDED|95.0|2.27|18.26||Significance level of 0.050 for 2-sided tests.|Cochran-Mantel-Haenszel|||Odds ratio 95% CIs, and p-value were estimated from the CMH test stratified by the geographical regions defined at randomization. To control the overall Type 1 error rate for outcomes 2-4, the testing procedure was implemented strictly in order: the test for this outcome was only conducted when there was evidence showing that erythroid response was achieved in the luspatercept group from Week 13 to Week 24 (primary endpoint).||18.26|2.27|<0.0001
70961257|NCT02604433|141427619|SUPERIORITY||Odds Ratio (OR)|4.24||||0.0402|TWO_SIDED|95.0|0.96|18.79||Significance level of 0.050 for 2-sided tests.|Cochran-Mantel-Haenszel|||Odds ratio, 95% CIs, and p-value were estimated from the Cochran-Mantel-Haenszel (CMH) test stratified by the geographical regions defined at randomization. To control the overall Type 1 error rate, the testing procedure was done strictly in order: the test for this outcome was only conducted when there was evidence showing erythroid response was achieved in the luspatercept group for the primary endpoint, and 33% hematological improvement was achieved in the luspatercept group in outcome 2.||18.79|0.96|0.0402
70881006|NCT00362115|141247110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.0098|TWO_SIDED|95.0|-7.81|-1.08||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.08|-7.81|0.0098
70881007|NCT00362115|141247110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3||||0.0113|TWO_SIDED|95.0|-7.68|-0.98||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.98|-7.68|0.0113
70961258|NCT02604433|141427620|SUPERIORITY||Odds Ratio (OR)|11.92||||0.0017|TWO_SIDED|95.0|1.65|86.29||Significance level of 0.050 for 2-sided tests.|Cochran-Mantel-Haenszel|||Odds ratio, 95% CIs, and p-value were estimated from the Cochran-Mantel-Haenszel (CMH) test stratified by the geographical regions defined at randomization. To control the overall Type 1 error rate, the testing procedure was done strictly in order: the test for this outcome was only conducted when there was evidence showing erythroid response was achieved in the luspatercept group for the primary endpoint, and achievement of objective in the luspatercept group in outcomes 2+3.||86.29|1.65|0.0017
70961259|NCT02604433|141427621|SUPERIORITY||LSM Difference|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.76|-0.93||Significance level of 0.050 for 2-sided tests.|ANCOVA|Estimates were based on an ANCOVA model with geographical regions defined at randomization and baseline transfusion burden as covariates.|luspatercept - placebo|Change from baseline at Week 48 LSM = least squares mean||-0.93|-1.76|<0.0001
70961260|NCT02604433|141427622|SUPERIORITY||LS Mean of Difference|0.2||||0.7598|TWO_SIDED|95.0|-1.1|1.51||Significance level of 0.050 for 2-sided tests.|ANCOVA||luspatercept - placebo|Change from baseline at Week 48 P-value ANCOVA model with geographical regions defined at randomization and baseline LIC as covariates. LS = least square||1.51|-1.10|0.7598
70961261|NCT02604433|141427623|SUPERIORITY||LS Mean of Difference|-68.0||||0.2552|TWO_SIDED|95.0|-185.8|49.7||Significance level of 0.050 for 2-sided tests|ANCOVA|Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline ICT as covariates.|luspatercept - placebo|Deferasirox: Change from baseline at Week 48 LS = least squares||49.7|-185.8|0.2552
70961262|NCT02604433|141427623|SUPERIORITY||LS Mean of Difference|-76.4||||0.7746|TWO_SIDED|95.0|-612.9|460.1||Significance level of 0.050 for 2-sided tests|ANCOVA|Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline ICT as covariates.|luspatercept - placebo|Deferiprone: Change from baseline at Week 48 LS = least squares||460.1|-612.9|0.7746
70961263|NCT02604433|141427623|SUPERIORITY||LS Mean of Difference|-147.3||||0.5186|TWO_SIDED|95.0|-673.1|378.5||Significance level of 0.050 for 2-sided tests|ANCOVA|Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline ICT as covariates.|luspatercept - placebo|Deferoxamine Mesilate / Deferoxamine: Change from baseline at Week 48 LS = least squares||378.5|-673.1|0.5186
70961264|NCT02604433|141427624|SUPERIORITY||LS Mean of Difference|-342.59|||<|0.0001|TWO_SIDED|95.0|-498.3|-186.87||Significance level of 0.050 for 2-sided tests|ANCOVA|Estimates based on an ANCOVA model with geographical regions defined at randomization and baseline serum ferritin as covariates.|luspatercept - placebo|Change from baseline at Week 48 LS = least squares||-186.87|-498.30|<0.0001
70961265|NCT02604433|141427625|SUPERIORITY||LS Mean of Difference|0.0||||0.9201|TWO_SIDED|95.0|-0.01|0.01||Significance level of 0.050 for 2-sided tests.|ANCOVA|Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline BMD measurement as covariates.|luspatercept - placebo|Total Hip Bone Mineral Density: Change from baseline at Week 48 LS = least squares||0.01|-0.01|0.9201
70961266|NCT02604433|141427625|SUPERIORITY||LS Mean of Difference|-0.01||||0.462|TWO_SIDED|95.0|-0.02|0.01||Significance level of 0.050 for 2-sided tests.|ANCOVA|Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline BMD measurement as covariates.|luspatercept - placebo|Lumbar Spine Bone Mineral Density: Change from baseline at Week 48 LS = least squares||0.01|-0.02|0.4620
70961267|NCT02604433|141427626|SUPERIORITY||LS Mean of Difference|-2.22||||0.0543|TWO_SIDED|95.0|-4.48|0.04||Significance level of 0.050 for 2-sided tests.|ANCOVA|Estimates were based on an ANCOVA model with geographical regions defined at randomization and baseline myocardial T2\* as covariates.|luspatercept - placebo|Change from baseline at Week 48 LS = least square||0.04|-4.48|0.0543
70961268|NCT02604433|141427627|SUPERIORITY|||||||0.666||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||Physical Health Domain Score - Change from Baseline at Week 24||||0.666
70961269|NCT02604433|141427627|SUPERIORITY|||||||0.384||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||Total Score - Change from Baseline at Week 24||||0.384
70961270|NCT02604433|141427628|SUPERIORITY|||||||0.918||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||Physical Functioning Domain - Change from Baseline at Week 24||||0.918
70961271|NCT02604433|141427628|SUPERIORITY|||||||0.857||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||General Health Domain - Change from Baseline at Week 24||||0.857
70961272|NCT02604433|141427628|SUPERIORITY|||||||0.839||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||PCS - Change from Baseline at Week 24||||0.839
70961273|NCT02604433|141427631|SUPERIORITY||Odds Ratio (OR)|7.6||||0.0015|TWO_SIDED|95.0|1.8|32.9||Significance level of 0.050 for 2-sided tests.|Cochran-Mantel-Haenszel|||Odds ratio 95% confidence intervals (CIs), and p-value were estimated from the Cochran Mantel-Haenszel (CMH) test stratified by the geographical regions defined at randomization.||32.9|1.8|0.0015
70961274|NCT02604433|141427634|SUPERIORITY||Mean Difference (Final Values)|-67.27||||0.0195|TWO_SIDED|95.0|-123.63|-10.91||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided||luspatercept - placebo|≥ 33% Transfusion Burden Reduction||-10.91|-123.63|0.0195
70961275|NCT02604433|141427634|SUPERIORITY||Mean Difference (Final Values)|28.24||||0.7473|TWO_SIDED|95.0|-144.87|201.34||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided||luspatercept - placebo|≥ 50% Transfusion Burden Reduction||201.34|-144.87|0.7473
70961276|NCT01326533|141427682|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANCOVA|Adjusted for baseline value as covariate||||||<0.01
70961277|NCT01326533|141427683|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||ANCOVA|Adjusted for baseline value as covariate||||||0.013
70881008|NCT00362115|141247110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.3416|TWO_SIDED|95.0|-1.68|4.84||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.84|-1.68|0.3416
70881009|NCT00362115|141247110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.8973|TWO_SIDED|95.0|-3.49|3.06||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.06|-3.49|0.8973
70881010|NCT00362115|141247110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.7292|TWO_SIDED|95.0|-2.69|3.84||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.84|-2.69|0.7292
70881011|NCT00362115|141247110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.7646|TWO_SIDED|95.0|-3.79|2.79||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.79|-3.79|0.7646
70881012|NCT00362115|141247110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.8133|TWO_SIDED|95.0|-3.67|2.88||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.88|-3.67|0.8133
70881013|NCT00362115|141247111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.5|||<|0.0001|TWO_SIDED|95.0|-12.51|-4.51||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.51|-12.51|< 0.0001
70881014|NCT00362115|141247111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.1|||<|0.0001|TWO_SIDED|95.0|-17.31|-8.9||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.90|-17.31|< 0.0001
70881015|NCT00362115|141247111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.1|||<|0.0001|TWO_SIDED|95.0|-16.27|-7.95||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.95|-16.27|< 0.0001
70881016|NCT00362115|141247111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|||<|0.0001|TWO_SIDED|95.0|-21.07|-12.46||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-12.46|-21.07|< 0.0001
70881017|NCT00362115|141247111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.4|||<|0.0001|TWO_SIDED|95.0|-17.58|-9.17||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.17|-17.58|< 0.0001
70881018|NCT00362115|141247111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.3735|TWO_SIDED|95.0|-2.1|5.58||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||5.58|-2.10|0.3735
70881019|NCT00362115|141247111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9||||0.1668|TWO_SIDED|95.0|-6.91|1.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.20|-6.91|0.1668
70881020|NCT00362115|141247111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.3629|TWO_SIDED|95.0|-5.86|2.15||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.15|-5.86|0.3629
70881021|NCT00362115|141247111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5||||0.0022|TWO_SIDED|95.0|-10.67|-2.36||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.36|-10.67|0.0022
70881022|NCT00362115|141247111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1||||0.1303|TWO_SIDED|95.0|-7.18|0.93||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.93|-7.18|0.1303
70881023|NCT00362115|141247112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.4|||<|0.0001|TWO_SIDED|95.0|-8.12|-2.72||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.72|-8.12|< 0.0001
70881024|NCT00362115|141247112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.5|||<|0.0001|TWO_SIDED|95.0|-11.33|-5.65||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.65|-11.33|< 0.0001
70881025|NCT00362115|141247112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.7|||<|0.0001|TWO_SIDED|95.0|-11.52|-5.9||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.90|-11.52|< 0.0001
70881026|NCT00362115|141247112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|||<|0.0001|TWO_SIDED|95.0|-13.73|-7.91||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.91|-13.73|< 0.0001
70881027|NCT00362115|141247112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.5|||<|0.0001|TWO_SIDED|95.0|-12.31|-6.64||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.64|-12.31|< 0.0001
70881028|NCT00362115|141247112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.1249|TWO_SIDED|95.0|-0.56|4.61||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.61|-0.56|0.1249
70881029|NCT00362115|141247112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.4542|TWO_SIDED|95.0|-3.79|1.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.70|-3.79|0.4542
70881030|NCT00362115|141247112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.3574|TWO_SIDED|95.0|-3.97|1.44||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.44|-3.97|0.3574
70881031|NCT00362115|141247112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.0184|TWO_SIDED|95.0|-6.18|-0.57||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.57|-6.18|0.0184
70881032|NCT00362115|141247112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.145|TWO_SIDED|95.0|-4.77|0.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.70|-4.77|0.1450
70961278|NCT00926211|141427684|NON_INFERIORITY_OR_EQUIVALENCE|Initial planned sample size of 26 would provide approximately 90% power if the survival rate in the implanted transected follicles is at least 40%. Sample size used was 36 with 35 participants completing the 9 month study.|Mean Difference (Net)|-1.4|STANDARD_DEVIATION|15.5||0.023|ONE_SIDED|97.5||3.9||t-test comparison to the upper limit of the non-inferiority margin|t-test, 1 sided|Paired t-test compared to the non-inferiority margin of 4 follicles.|The number of implanted hairs surviving that were harvested using the computer assisted method was subtracted from the number of implanted hairs surviving that were harvested manually.|The hypothesis to be tested is one of non-inferiority. Tests of non-inferiority are one-sided tests and the significance level will be 0.025.||3.9||0.023
70961279|NCT00926211|141427685|NON_INFERIORITY_OR_EQUIVALENCE|Study was powered for the primary efficacy outcome.|Mean Difference (Final Values)|0.045|STANDARD_DEVIATION|0.146|<|0.001|ONE_SIDED|97.5|-0.004||||t-test, 1 sided|Paired t-test.||Paired data with each subject as their own control (treatment was randomly assigned to the left or right side of the scalp). Paired difference was analyzed.|||-.004|<0.001
70961280|NCT00078754|141427686|SUPERIORITY_OR_OTHER_LEGACY|||||||0.622|TWO_SIDED||||||ANCOVA|||||||0.622
70961281|NCT00078754|141427687|SUPERIORITY|||||||0.029||||||LHA score main effect.|ANCOVA|The LHA Score F\[1,83\] = 4.91, p = 0.029; Condition F\[2,83\] = 0.20, p = 0.815; Condition x LHA Score F\[2,83\] = 0.255, p = 0.799.||The hypothesis was that subjects with LHA Scores = 18 or more would respond better to divalproex (than fluoxetine) while those with LHA scores = or \< 17 would respond better to fluoxetine (than divalproex).||||0.029
70961282|NCT00078754|141427687|SUPERIORITY||Mean Difference (Final Values)|19.0|STANDARD_ERROR_OF_MEAN|2.7||0.8|TWO_SIDED||||||ANCOVA|Baseline OAS-M Aggression score as covariate.||ANCOVA at endpoint with baseline OAS-M AGG score as covariate.||||0.80
70961283|NCT02240693|141427743|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.075||0.3236|TWO_SIDED|95.0|-0.074|0.223||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 10 milligram (mg) once daily (QD) minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|0.223|-0.074|0.3236
70961284|NCT02240693|141427743|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.076||0.3694|TWO_SIDED|95.0|-0.22|0.082||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg QD minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|0.082|-0.220|0.3694
70961285|NCT02240693|141427743|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.078||0.8374|TWO_SIDED|95.0|-0.171|0.139||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 50 mg QD minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.139|-0.171|0.8374
70961286|NCT02240693|141427743|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.077||0.5484|TWO_SIDED|95.0|-0.106|0.199||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg twice daily (BID) minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.199|-0.106|0.5484
70961287|NCT02240693|141427743|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.054||0.7905|TWO_SIDED|95.0|-0.092|0.121||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (Pooled BI 409306 minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.121|-0.092|0.7905
70881033|NCT00362115|141247113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.9||||0.0009|TWO_SIDED|95.0|-12.46|-3.26||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.26|-12.46|0.0009
70881034|NCT00362115|141247113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.6|||<|0.0001|TWO_SIDED|95.0|-18.46|-8.77||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.77|-18.46|< 0.0001
70881035|NCT00362115|141247113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4|||<|0.0001|TWO_SIDED|95.0|-17.21|-7.63||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.63|-17.21|< 0.0001
70881036|NCT00362115|141247113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.9|||<|0.0001|TWO_SIDED|95.0|-22.83|-12.92||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-12.92|-22.83|< 0.0001
70881037|NCT00362115|141247113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||<|0.0001|TWO_SIDED|95.0|-18.52|-8.84||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.84|-18.52|< 0.0001
70881038|NCT00362115|141247113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.9424|TWO_SIDED|95.0|-4.25|4.58||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.58|-4.25|0.9424
70881039|NCT00362115|141247113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6||||0.0189|TWO_SIDED|95.0|-10.26|-0.93||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.93|-10.26|0.0189
70881040|NCT00362115|141247113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.0612|TWO_SIDED|95.0|-9.01|0.21||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.21|-9.01|0.0612
70881041|NCT00362115|141247113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.9|||<|0.0001|TWO_SIDED|95.0|-14.63|-5.07||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.07|-14.63|< 0.0001
70881042|NCT00362115|141247113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.0175|TWO_SIDED|95.0|-10.33|-1.0||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.00|-10.33|0.0175
70881043|NCT00362115|141247114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1||||0.0108|TWO_SIDED|95.0|-7.26|-0.95||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.95|-7.26|0.0108
70881044|NCT00362115|141247114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.9|||<|0.0001|TWO_SIDED|95.0|-11.16|-4.55||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.55|-11.16|< 0.0001
70881045|NCT00362115|141247114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.5|||<|0.0001|TWO_SIDED|95.0|-11.82|-5.26||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.26|-11.82|< 0.0001
70881046|NCT00362115|141247114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.6|||<|0.0001|TWO_SIDED|95.0|-13.98|-7.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.20|-13.98|< 0.0001
70881047|NCT00362115|141247114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2|||<|0.0001|TWO_SIDED|95.0|-12.52|-5.9||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.90|-12.52|< 0.0001
70881048|NCT00362115|141247114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.306|TWO_SIDED|95.0|-1.45|4.59||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.59|-1.45|0.3060
70881049|NCT00362115|141247114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.1823|TWO_SIDED|95.0|-5.37|1.02||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.02|-5.37|0.1823
70881050|NCT00362115|141247114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9||||0.0751|TWO_SIDED|95.0|-6.01|0.29||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.29|-6.01|0.0751
70881051|NCT00362115|141247114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9||||0.0034|TWO_SIDED|95.0|-8.18|-1.64||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.64|-8.18|0.0034
70881052|NCT00362115|141247114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.0306|TWO_SIDED|95.0|-6.72|-0.33||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.33|-6.72|0.0306
70881053|NCT00362115|141247115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1||||0.0061|TWO_SIDED|95.0|-13.9|-2.33||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.33|-13.90|0.0061
70881054|NCT00362115|141247115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.5||||0.0002|TWO_SIDED|95.0|-17.56|-5.44||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.44|-17.56|0.0002
70881055|NCT00362115|141247115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.3|||<|0.0001|TWO_SIDED|95.0|-18.34|-6.28||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.28|-18.34|< 0.0001
70881056|NCT00362115|141247115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.5|||<|0.0001|TWO_SIDED|95.0|-23.75|-11.34||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-11.34|-23.75|< 0.0001
70881057|NCT00362115|141247115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.8|||<|0.0001|TWO_SIDED|95.0|-19.86|-7.8||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.80|-19.86|< 0.0001
70881058|NCT00362115|141247115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.9355|TWO_SIDED|95.0|-5.74|5.28||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||5.28|-5.74|0.9355
70881059|NCT00362115|141247115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.2223|TWO_SIDED|95.0|-9.41|2.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.20|-9.41|0.2223
70881060|NCT00362115|141247115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.1328|TWO_SIDED|95.0|-10.19|1.35||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.35|-10.19|0.1328
70881061|NCT00362115|141247115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.7||||0.0016|TWO_SIDED|95.0|-15.61|-3.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.70|-15.61|0.0016
70881062|NCT00362115|141247115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9||||0.0437|TWO_SIDED|95.0|-11.7|-0.17||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.17|-11.70|0.0437
70881063|NCT00362115|141247116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3||||0.0417|TWO_SIDED|95.0|-8.39|-0.16||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.16|-8.39|0.0417
70881064|NCT00362115|141247116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||0.0053|TWO_SIDED|95.0|-10.44|-1.84||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.84|-10.44|0.0053
70881065|NCT00362115|141247116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.8||||0.0004|TWO_SIDED|95.0|-12.12|-3.56||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.56|-12.12|0.0004
70881066|NCT00362115|141247116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.6|||<|0.0001|TWO_SIDED|95.0|-13.97|-5.16||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.16|-13.97|< 0.0001
70881067|NCT00362115|141247116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.3|||<|0.0001|TWO_SIDED|95.0|-13.6|-5.03||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.03|-13.60|< 0.0001
70881068|NCT00362115|141247116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.6372|TWO_SIDED|95.0|-2.97|4.85||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.85|-2.97|0.6372
70881069|NCT00362115|141247116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.6588|TWO_SIDED|95.0|-5.05|3.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.20|-5.05|0.6588
70881070|NCT00362115|141247116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.2082|TWO_SIDED|95.0|-6.72|1.47||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.47|-6.72|0.2082
70881071|NCT00362115|141247116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3||||0.0437|TWO_SIDED|95.0|-8.57|-0.12||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.12|-8.57|0.0437
70881072|NCT00362115|141247116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1||||0.0495|TWO_SIDED|95.0|-8.19|-0.01||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.01|-8.19|0.0495
70881073|NCT00362115|141247117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.4||||0.0007|TWO_SIDED|95.0|-14.74|-3.97||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.97|-14.74|0.0007
70881074|NCT00362115|141247117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.4|||<|0.0001|TWO_SIDED|95.0|-19.02|-7.73||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.73|-19.02|< 0.0001
70881075|NCT00362115|141247117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4||||0.0003|TWO_SIDED|95.0|-16.0|-4.83||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.83|-16.00|0.0003
70881076|NCT00362115|141247117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.3|||<|0.0001|TWO_SIDED|95.0|-23.11|-11.47||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-11.47|-23.11|< 0.0001
70881077|NCT00362115|141247117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4|||<|0.0001|TWO_SIDED|95.0|-18.01|-6.78||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.78|-18.01|< 0.0001
70881078|NCT00362115|141247117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9||||0.2594|TWO_SIDED|95.0|-2.17|8.01||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||8.01|-2.17|0.2594
70881079|NCT00362115|141247117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.6859|TWO_SIDED|95.0|-6.46|4.26||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.26|-6.46|0.6859
70881080|NCT00362115|141247117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9||||0.4898|TWO_SIDED|95.0|-3.43|7.15||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||7.15|-3.43|0.4898
70881081|NCT00362115|141247117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.0||||0.076|TWO_SIDED|95.0|-10.55|0.53||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.53|-10.55|0.0760
70881082|NCT00362115|141247117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.9647|TWO_SIDED|95.0|-5.44|5.21||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||5.21|-5.44|0.9647
70881083|NCT00362115|141247118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.3||||0.0002|TWO_SIDED|95.0|-11.13|-3.43||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.43|-11.13|0.0002
70881084|NCT00362115|141247118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0|||<|0.0001|TWO_SIDED|95.0|-15.01|-6.97||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.97|-15.01|< 0.0001
70881085|NCT00362115|141247118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6|||<|0.0001|TWO_SIDED|95.0|-12.59|-4.64||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.64|-12.59|< 0.0001
70881086|NCT00362115|141247118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.6|||<|0.0001|TWO_SIDED|95.0|-17.79|-9.5||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.50|-17.79|< 0.0001
70881087|NCT00362115|141247118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.7|||<|0.0001|TWO_SIDED|95.0|-12.69|-4.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.70|-12.69|< 0.0001
70881088|NCT00362115|141247118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.279|TWO_SIDED|95.0|-1.63|5.62||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||5.62|-1.63|0.2790
70881089|NCT00362115|141247118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.3772|TWO_SIDED|95.0|-5.53|2.1||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.10|-5.53|0.3772
70881090|NCT00362115|141247118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.7302|TWO_SIDED|95.0|-3.11|4.43||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.43|-3.11|0.7302
70881091|NCT00362115|141247118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.0302|TWO_SIDED|95.0|-8.31|-0.42||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.42|-8.31|0.0302
70881092|NCT00362115|141247118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.7644|TWO_SIDED|95.0|-3.22|4.38||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.38|-3.22|0.7644
70961288|NCT02240693|141427744|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|1.102||0.8973|TWO_SIDED|95.0|-2.33|2.04||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 10 milligram (mg) once daily (QD) minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|2.04|-2.33|0.8973
70961289|NCT02240693|141427744|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|1.122||0.2141|TWO_SIDED|95.0|-0.82|3.63||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 25 mg QD minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|3.63|-0.82|0.2141
70961290|NCT02240693|141427744|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|1.085||0.6553|TWO_SIDED|95.0|-2.64|1.67||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 50 mg QD minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|1.67|-2.64|0.6553
70961291|NCT02240693|141427744|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|1.144||0.7166|TWO_SIDED|95.0|-1.85|2.69||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 25 mg twice daily (BID) minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|2.69|-1.85|0.7166
70961292|NCT02240693|141427745|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.24||0.9491|TWO_SIDED|95.0|-0.49|0.46||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 10 milligram (mg) once daily (QD) minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|0.46|-0.49|0.9491
70961293|NCT02240693|141427745|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.25||0.1699|TWO_SIDED|95.0|-0.15|0.84||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg QD minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|0.84|-0.15|0.1699
70961294|NCT02240693|141427745|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.26||0.4948|TWO_SIDED|95.0|-0.69|0.33||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 50 mg QD minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.33|-0.69|0.4948
70881093|NCT00362115|141247119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.4||||0.0001|TWO_SIDED|95.0|-12.7|-4.19||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.19|-12.70|0.0001
70881094|NCT00362115|141247119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||<|0.0001|TWO_SIDED|95.0|-18.19|-9.24||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.24|-18.19|< 0.0001
70881095|NCT00362115|141247119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.2|||<|0.0001|TWO_SIDED|95.0|-16.66|-7.8||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.80|-16.66|< 0.0001
70961295|NCT02240693|141427745|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.25||0.7548|TWO_SIDED|95.0|-0.42|0.58||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg twice daily (BID) minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.58|-0.42|0.7548
70961296|NCT02240693|141427746|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|1.081||0.8137|TWO_SIDED|95.0|-2.4|1.89||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 10 milligram (mg) once daily (QD) minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|1.89|-2.40|0.8137
70961297|NCT02240693|141427746|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|1.12||0.5801|TWO_SIDED|95.0|-2.84|1.6||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 25 mg QD minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|1.60|-2.84|0.5801
70961298|NCT02240693|141427746|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|1.072||0.2978|TWO_SIDED|95.0|-3.25|1.0||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 50 mg QD minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|1.00|-3.25|0.2978
70961299|NCT02240693|141427746|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-2.51|STANDARD_ERROR_OF_MEAN|1.072||0.0209|TWO_SIDED|95.0|-4.64|-0.39||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 25 mg twice daily (BID) minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|-0.39|-4.64|0.0209
70961300|NCT02240693|141427747|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.056||0.8694|TWO_SIDED|95.0|-0.101|0.12||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 10 milligram (mg) once daily (QD) minus Placebo matching BI 409306)|"Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.~The study identifier is also a categorical covariate for the twin studies analyses."|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|0.120|-0.101|0.8694
70961301|NCT02240693|141427747|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.057||0.9512|TWO_SIDED|95.0|-0.116|0.109||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg QD minus Placebo matching BI 409306)|"Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.~The study identifier is also a categorical covariate for the twin studies analyses."|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|0.109|-0.116|0.9512
70881096|NCT00362115|141247119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.9|||<|0.0001|TWO_SIDED|95.0|-22.51|-13.35||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-13.35|-22.51|< 0.0001
70961302|NCT02240693|141427747|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.056||0.9321|TWO_SIDED|95.0|-0.105|0.115||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 50 mg QD minus Placebo matching BI 409306)|"Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.~The study identifier is also a categorical covariate for the twin studies analyses."|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.115|-0.105|0.9321
70881097|NCT00362115|141247119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||<|0.0001|TWO_SIDED|95.0|-18.21|-9.25||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.25|-18.21|< 0.0001
70881098|NCT00362115|141247119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.6905|TWO_SIDED|95.0|-3.26|4.91||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.91|-3.26|0.6905
70881099|NCT00362115|141247119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.0433|TWO_SIDED|95.0|-8.76|-0.13||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.13|-8.76|0.0433
70881100|NCT00362115|141247119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.1736|TWO_SIDED|95.0|-7.22|1.31||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.31|-7.22|0.1736
70881101|NCT00362115|141247119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.7||||0.0001|TWO_SIDED|95.0|-13.08|-4.23||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.23|-13.08|0.0001
70881102|NCT00362115|141247119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5||||0.0429|TWO_SIDED|95.0|-8.77|-0.14||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANOVA|||||-0.14|-8.77|0.0429
70881103|NCT00362115|141247120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9||||0.0009|TWO_SIDED|95.0|-7.77|-2.04||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.04|-7.77|0.0009
70881104|NCT00362115|141247120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.3|||<|0.0001|TWO_SIDED|95.0|-11.33|-5.32||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.32|-11.33|< 0.0001
70881105|NCT00362115|141247120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.7|||<|0.0001|TWO_SIDED|95.0|-11.63|-5.67||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.67|-11.63|< 0.0001
70881106|NCT00362115|141247120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.3|||<|0.0001|TWO_SIDED|95.0|-14.34|-8.18||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.18|-14.34|< 0.0001
70881107|NCT00362115|141247120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.4|||<|0.0001|TWO_SIDED|95.0|-12.37|-6.36||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.36|-12.37|< 0.0001
70881108|NCT00362115|141247120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.2068|TWO_SIDED|95.0|-0.98|4.5||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.50|-0.98|0.2068
70881109|NCT00362115|141247120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.2622|TWO_SIDED|95.0|-4.56|1.25||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.25|-4.56|0.2622
70881110|NCT00362115|141247120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.173|TWO_SIDED|95.0|-4.85|0.88||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.88|-4.85|0.1730
70881111|NCT00362115|141247120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6||||0.0025|TWO_SIDED|95.0|-7.56|-1.62||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.62|-7.56|0.0025
70881112|NCT00362115|141247120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.0681|TWO_SIDED|95.0|-5.6|0.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.20|-5.60|0.0681
70881113|NCT00362115|141247121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6||||0.0004|TWO_SIDED|95.0|-13.28|-3.87||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.87|-13.28|0.0004
70881114|NCT00362115|141247121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.3|||<|0.0001|TWO_SIDED|95.0|-17.26|-7.42||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.42|-17.26|< 0.0001
70881115|NCT00362115|141247121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6|||<|0.0001|TWO_SIDED|95.0|-16.51|-6.78||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.78|-16.51|< 0.0001
70881116|NCT00362115|141247121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.3|||<|0.0001|TWO_SIDED|95.0|-19.38|-9.25||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.25|-19.38|< 0.0001
70881117|NCT00362115|141247121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.6|||<|0.0001|TWO_SIDED|95.0|-17.53|-7.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.70|-17.53|< 0.0001
70881118|NCT00362115|141247121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3||||0.1479|TWO_SIDED|95.0|-1.17|7.72||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||7.72|-1.17|0.1479
70881119|NCT00362115|141247121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.8382|TWO_SIDED|95.0|-5.16|4.19||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.19|-5.16|0.8382
70881120|NCT00362115|141247121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.9317|TWO_SIDED|95.0|-4.42|4.82||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.82|-4.42|0.9317
70881121|NCT00362115|141247121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.3169|TWO_SIDED|95.0|-7.29|2.37||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.37|-7.29|0.3169
70961303|NCT02240693|141427747|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.057||0.1288|TWO_SIDED|95.0|-0.199|0.025||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg twice daily (BID) minus Placebo matching BI 409306)|"Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.~The study identifier is also a categorical covariate for the twin studies analyses."|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.025|-0.199|0.1288
70961304|NCT02240693|141427747|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.041||0.6492|TWO_SIDED|95.0|-0.098|0.061||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (Pooled BI 409306 minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.061|-0.098|0.6492
70961305|NCT03291587|141427751|SUPERIORITY|With 418 analyzable participants across 13 clinics per group, we have 80% power to detect a group difference in primary outcome (7-day abstinence). This assumes control abstinence rate will be 10% versus 20% intervention rate using a 2-sided Z-test for proportions with alpha=0.05 (2-sided). To account for the clustering we used an intra-class correlation value of 0.03. We plan to enroll 1114-1300 patients (or approximately 42-50 per site) to conservatively allow for 25%- 35.5% loss to follow-up.|Odds Ratio (OR)|0.967||||0.865|TWO_SIDED|96.0|0.652|1.433|||Mixed Models Analysis|||A generalized estimating equation marginal model was used in an intent-to-treat analysis to predict the 7-day tobacco use binary outcome. A binomial distribution with logit link was specified with group, time, and the interaction of group by time included as covariates while allowing intercept and time to vary by participants within site with an exchangeable working correlation matrix designation.||1.433|0.652|0.865
70961306|NCT02197767|141427760|SUPERIORITY|||||||0.072|||||||t-test, 2 sided|||||||0.072
70961307|NCT02197767|141427761|SUPERIORITY|||||||0.068|||||||t-test, 2 sided|||||||0.068
70961308|NCT00413972|141427767|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<.0001
70961309|NCT00413972|141427767|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<.0001
70961310|NCT00413972|141427767|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<.0001
70961311|NCT00381303|141427775|NON_INFERIORITY_OR_EQUIVALENCE|Test for non-inferiority (Delta=15%)|Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|0.052||0.3|TWO_SIDED|95.0|-19.85|0.68||P-Value for difference (Female - Male): Test for non-inferiority (Delta=15%)|Regression, Logistic|Estimates from logistic regression analysis include baseline log10 viral load and baseline CD4 cell count as covariates and gender as a factor.||"Confidence interval of the difference in proportion of response between two sexes estimated by:~* Application of delta method to be obtained Standard Error (SE)~* Calculation of lower and upper bound using normal approximation to the difference in response rates"||0.68|-19.85|0.30
70961312|NCT03933774|141427785|SUPERIORITY|||||||0.002||||||P value \< 0.05 was considered significant.|t-test, 2 sided|||Null hypothesis: The degree of hyperpigmentation is the same between the tretinoin applied side and placebo applied side.||||0.002
70961313|NCT03933774|141427786|SUPERIORITY|||||||0.479||||||P value \< 0.05 was considered significant.|McNemar|||Null hypothesis: The number of participants who showed ≥75% repigmentation is the same between the tretinoin applied side and placebo applied side.||||0.479
70961314|NCT01966471|141427787|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.827||95.0|0.71|1.32|||Log Rank|||||1.32|0.71|0.8270
70961315|NCT01966471|141427788|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9291||95.0|0.77|1.34|||Log Rank|||||1.34|0.77|0.9291
70961316|NCT01966471|141427789|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.8756||95.0|0.74|1.3|||Log Rank|||||1.30|0.74|0.8756
70961317|NCT01966471|141427790|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9341||95.0|0.75|1.31|||Log Rank|||||1.31|0.75|0.9341
70961318|NCT01966471|141427791|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.4577||95.0|0.61|1.25|||Log Rank|||||1.25|0.61|0.4577
70961319|NCT01966471|141427792|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.2864||95.0|0.83|1.84|||Log Rank|||||1.84|0.83|0.2864
70961320|NCT01163721|141427828|SUPERIORITY_OR_OTHER||difference in least squares mean (LSM)|-0.53|STANDARD_ERROR_OF_MEAN|0.2||0.01|TWO_SIDED|95.0|-0.93|-0.13||P-value is from an Analysis of Covariance (ANCOVA) model with treatment as factor and baseline HbA1c value as covariate. Due to the exploratory nature of this study, there were no adjustments for multiplicity.|ANCOVA|||Assuming a common standard deviation of 1.1%, 60 evaluable participants would provide 93% power to detect a statistically significant -1.0% difference in change from baseline HbA1c at Week 12 between ranolazine and placebo (2-sided alpha = 0.05). 80 participants were randomized to ensure at least 60 evaluable participants.||-0.13|-0.93|0.010
70961321|NCT01163721|141427829|SUPERIORITY_OR_OTHER||difference in LSM|-15.4|STANDARD_ERROR_OF_MEAN|12.83||0.234|TWO_SIDED|95.0|-41.0|10.2||P-value is from an ANCOVA model with treatment and baseline HbA1c stratification as factors and baseline value as covariate.|ANCOVA|||||10.2|-41.0|0.234
70881122|NCT00362115|141247121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.7488|TWO_SIDED|95.0|-5.44|3.91||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.91|-5.44|0.7488
70881123|NCT00362115|141247122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||<|0.0001|TWO_SIDED|95.0|-9.98|-3.4||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.40|-9.98|< 0.0001
70881124|NCT00362115|141247122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.3|||<|0.0001|TWO_SIDED|95.0|-12.76|-5.86||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.86|-12.76|< 0.0001
70881125|NCT00362115|141247122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6|||<|0.0001|TWO_SIDED|95.0|-12.05|-5.22||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.22|-12.05|< 0.0001
70881126|NCT00362115|141247122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4|||<|0.0001|TWO_SIDED|95.0|-13.92|-6.79||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.79|-13.92|< 0.0001
70881127|NCT00362115|141247122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.7|||<|0.0001|TWO_SIDED|95.0|-13.11|-6.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.20|-13.11|< 0.0001
70881128|NCT00362115|141247122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.4188|TWO_SIDED|95.0|-1.83|4.4||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.40|-1.83|0.4188
70881129|NCT00362115|141247122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.4255|TWO_SIDED|95.0|-4.62|1.95||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.95|-4.62|0.4255
70881130|NCT00362115|141247122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.6869|TWO_SIDED|95.0|-3.91|2.58||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.58|-3.91|0.6869
70881131|NCT00362115|141247122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.1678|TWO_SIDED|95.0|-5.77|1.01||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.01|-5.77|0.1678
70881132|NCT00362115|141247122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.3132|TWO_SIDED|95.0|-4.96|1.6||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.60|-4.96|0.3132
70881133|NCT00362115|141247123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.0||||0.0005|TWO_SIDED|95.0|-12.48|-3.52||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.52|-12.48|0.0005
70881134|NCT00362115|141247123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.6|||<|0.0001|TWO_SIDED|95.0|-15.24|-5.93||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.93|-15.24|< 0.0001
70881135|NCT00362115|141247123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.1|||<|0.0001|TWO_SIDED|95.0|-14.7|-5.44||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.44|-14.70|< 0.0001
70881136|NCT00362115|141247123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.2|||<|0.0001|TWO_SIDED|95.0|-17.95|-8.42||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.42|-17.95|< 0.0001
70881137|NCT00362115|141247123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.1|||<|0.0001|TWO_SIDED|95.0|-16.74|-7.48||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.48|-16.74|< 0.0001
70881138|NCT00362115|141247123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.8103|TWO_SIDED|95.0|-4.79|3.75||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.75|-4.79|0.8103
70881139|NCT00362115|141247123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1||||0.1702|TWO_SIDED|95.0|-7.57|1.34||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.34|-7.57|0.1702
70881140|NCT00362115|141247123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.2504|TWO_SIDED|95.0|-7.02|1.84||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.84|-7.02|0.2504
70881141|NCT00362115|141247123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.0144|TWO_SIDED|95.0|-10.28|-1.14||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.14|-10.28|0.0144
70881142|NCT00362115|141247123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6||||0.0402|TWO_SIDED|95.0|-9.06|-0.21||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.21|-9.06|0.0402
70881143|NCT00362115|141247124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.2||||0.0014|TWO_SIDED|95.0|-8.41|-2.04||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.04|-8.41|0.0014
70881144|NCT00362115|141247124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5|||<|0.0001|TWO_SIDED|95.0|-10.82|-4.22||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.22|-10.82|< 0.0001
70881145|NCT00362115|141247124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2|||<|0.0001|TWO_SIDED|95.0|-11.51|-4.93||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.93|-11.51|< 0.0001
70881146|NCT00362115|141247124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.1|||<|0.0001|TWO_SIDED|95.0|-12.49|-5.72||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.72|-12.49|< 0.0001
70961322|NCT01163721|141427830|SUPERIORITY_OR_OTHER||difference in least squares mean (LSM)|-2.5|STANDARD_ERROR_OF_MEAN|9.38||0.794|TWO_SIDED|95.0|-21.1|16.2||P-value is from an ANCOVA model with treatment and baseline HbA1c stratification as factors and baseline value as covariate.|ANCOVA|||||16.2|-21.1|0.794
70961323|NCT06515483|141427864|OTHER||Mean Difference (Final Values)|0.079||||0.323|TWO_SIDED|95.0|-0.095|0.254||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)||Comparing baseline PLI between groups|Due to non-normally distributed data, differences in each index between the experimental and control groups at baseline were compared using non-parametric Wilcoxon Rank Sum tests.||0.254|-0.095|0.323
70961324|NCT06515483|141427864|OTHER||Mean Difference (Final Values)|-0.036||||0.371|TWO_SIDED|95.0|-0.156|0.084||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)||Comparing 30-day PLI between groups|Due to non-normally distributed data, differences in each index between the experimental and control groups at 30 days were compared using non-parametric Wilcoxon Rank Sum tests.||0.084|-0.156|0.371
70961325|NCT06515483|141427864|OTHER||Mean Difference (Net)|-0.115||||0.12|TWO_SIDED|95.0|-0.262|0.031||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Comparing the mean difference in PLI from baseline to 30 days between groups|||0.031|-0.262|0.120
70961326|NCT06515483|141427865|OTHER||Mean Difference (Final Values)|0.078||||0.27|TWO_SIDED|95.0|-0.048|0.204||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)||Comparing baseline MGI between groups|Due to non-normally distributed data, differences in each index between the experimental and control groups at baseline were compared using non-parametric Wilcoxon Rank Sum tests.||0.204|-0.048|0.270
70961327|NCT06515483|141427865|OTHER||Mean Difference (Final Values)|-0.085||||0.071|TWO_SIDED|95.0|-0.203|0.033||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)||Comparing 30-day MGI between groups|Due to non-normally distributed data, differences in each index between the experimental and control groups at 30 days were compared using non-parametric Wilcoxon Rank Sum tests.||0.033|-0.203|0.071
70961328|NCT06515483|141427865|OTHER||Mean Difference (Net)|-0.163|||<|0.001|TWO_SIDED|95.0|-0.249|-0.077|||t-test, 2 sided||Comparing the mean difference in MGI from baseline to 30 days between groups|||-0.077|-0.249|<0.001
70961329|NCT06515483|141427866|OTHER||Mean Difference (Final Values)|0.31||||0.902|TWO_SIDED|95.0|-6.23|6.85||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)||Comparing baseline BOMP between groups|Due to non-normally distributed data, differences in each index between the experimental and control groups at baseline were compared using non-parametric Wilcoxon Rank Sum tests.||6.85|-6.23|0.902
70961330|NCT06515483|141427866|OTHER||Mean Difference (Final Values)|-8.22||||0.006|TWO_SIDED|95.0|-16.46|0.02||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)||Comparing 30-day BOMP between groups|Due to non-normally distributed data, differences in each index between the experimental and control groups at 30 days were compared using non-parametric Wilcoxon Rank Sum tests.||0.02|-16.46|0.006
70961331|NCT06515483|141427866|OTHER||Mean Difference (Net)|-8.53||||0.032|TWO_SIDED|95.0|-16.31|-0.75||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Comparing the mean difference in BOMP from baseline to 30 days between groups|||-0.75|-16.31|0.032
70961332|NCT00720941|141427873|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority is defined as excluding a difference of greater than 25% in the hazards. The upper limit of the 95% confidence interval must be \<1.25.|Hazard Ratio (HR)|1.0466|||||TWO_SIDED|95.0|0.8982|1.2195|||||The HR is estimated by the Cox regression model using treatment stratification factors as covariates. The HR is adjusted for Karnofsky Performance Scale scores, prior nephrectomy, and Baseline levels of lactate dehydrogenase (\<=1.5xULN, \>1.5xULN).|||1.2195|0.8982|
70961333|NCT01072877|141427906|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.49|||=|0.0001|TWO_SIDED|95.0|-3.72|-1.27|||ANCOVA|||||-1.27|-3.72|=0.0001
70961334|NCT01072877|141427906|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.54|||<|0.0001|TWO_SIDED|95.0|-4.8|-2.29|||ANCOVA|||||-2.29|-4.80|<0.0001
70961335|NCT01072877|141427906|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.73|||<|0.0001|TWO_SIDED|95.0|-3.98|-1.48|||ANCOVA|||||-1.48|-3.98|<0.0001
70961336|NCT01072877|141427906|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.65|||<|0.0001|TWO_SIDED|95.0|-4.84|-2.46|||ANCOVA|||||-2.46|-4.84|<0.0001
70961337|NCT01072877|141427907|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|||=|0.0001|TWO_SIDED|95.0|-1.17|-0.4|||ANCOVA|||||-0.40|-1.17|=0.0001
70961338|NCT01072877|141427907|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.26|||<|0.0001|TWO_SIDED|95.0|-1.65|-0.86|||ANCOVA|||||-0.86|-1.65|<0.0001
70961339|NCT01072877|141427907|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.45|||<|0.0001|TWO_SIDED|95.0|-1.85|-1.06|||ANCOVA|||||-1.06|-1.85|<0.0001
70961340|NCT01072877|141427907|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6|||<|0.0001|TWO_SIDED|95.0|-1.98|-1.23|||ANCOVA|||||-1.23|-1.98|<0.0001
70961341|NCT01072877|141427908|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|||=|0.0001|TWO_SIDED|95.0|-0.66|-0.23|||ANCOVA|||||-0.23|-0.66|=0.0001
70961342|NCT01072877|141427908|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.76|||<|0.0001|TWO_SIDED|95.0|-0.98|-0.53|||ANCOVA|||||-0.53|-0.98|<0.0001
70961343|NCT01072877|141427908|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75|||<|0.0001|TWO_SIDED|95.0|-0.97|-0.53|||ANCOVA|||||-0.53|-0.97|<0.0001
70961344|NCT01072877|141427908|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.11|-0.68|||ANCOVA|||||-0.68|-1.11|<0.0001
70961345|NCT00820027|141427927|SUPERIORITY||Difference in Least Squares Mean|-0.49||||0.018|TWO_SIDED|95.0|-0.89|-0.08|||longitudinal data analysis (LDA)|Estimate from LDA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.||||-0.08|-0.89|0.018
70961346|NCT00820027|141427927|SUPERIORITY||Difference in Least Squares Mean|-0.54||||0.009|TWO_SIDED|95.0|-0.95|-0.14|||LDA|Estimate from LDA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.||||-0.14|-0.95|0.009
70961347|NCT00820027|141427928|SUPERIORITY||Between-Treatment Ratio|0.69|||<|0.001|TWO_SIDED|95.0|0.56|0.85|||ANOVA|Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.|A ratio \<1 indicates a beneficial effect of Etoricoxib.|||0.85|0.56|<0.001
70961348|NCT00820027|141427928|SUPERIORITY||Between-Treatment Ratio|0.66|||<|0.001|TWO_SIDED|95.0|0.54|0.82|||ANOVA|Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.|A ratio \<1 indicates a beneficial effect of Etoricoxib.|||0.82|0.54|<0.001
70961349|NCT00820027|141427929|OTHER||Difference in Percent|0.5||||0.506|TWO_SIDED|95.0|-3.3|2.5|||Miettinen & Nurminen|||||2.5|-3.3|0.506
70961350|NCT00820027|141427929|OTHER||Difference in Percent|0.0|||>|0.999|TWO_SIDED|95.0|-3.8|1.7|||Miettinen & Nurminen|||||1.7|-3.8|>0.999
70961351|NCT00820027|141427929|OTHER||Difference in Percent|0.0|||>|0.999|TWO_SIDED|95.0|-3.8|1.7|||Miettinen & Nurminen|||||1.7|-3.8|>0.999
70961352|NCT00820027|141427929|OTHER||Difference in Percent|0.5||||0.316|TWO_SIDED|95.0|-1.3|2.5|||Miettinen & Nurminen|||||2.5|-1.3|0.316
70961353|NCT00820027|141427929|SUPERIORITY||Difference in Percent|0.0|||>|0.999|TWO_SIDED|95.0|-1.7|1.7|||Miettinen & Nurminen|||||1.7|-1.7|>0.999
70961354|NCT00820027|141427929|OTHER||Difference in Percent|0.0|||>|0.999|TWO_SIDED|95.0|-1.7|3.8|||Miettinen & Nurminen|||Placebo vs. Ibuprofen 1800 mg||3.8|-1.7|>0.999
70961355|NCT00820027|141427929|OTHER||Difference in Percent|-0.5||||0.309|TWO_SIDED|95.0|-2.5|1.2|||Miettinen & Nurminen|||||1.2|-2.5|0.309
70961356|NCT00820027|141427930|OTHER||Difference in Percent|-3.2||||0.054|TWO_SIDED|95.0|-9.2|0.1|||Miettinen & Nurminen|||||0.1|-9.2|0.054
70961357|NCT00820027|141427930|OTHER||Difference in Percent|-2.3||||0.209|TWO_SIDED|95.0|-8.4|1.2|||Miettinen & Nurminen|||||1.2|-8.4|0.209
70961358|NCT00820027|141427930|OTHER||Difference in Percent|-2.3||||0.227|TWO_SIDED|95.0|-8.4|1.3|||Miettinen & Nurminen|||||1.3|-8.4|0.227
70961359|NCT00820027|141427930|OTHER||Difference in Percent|-0.9||||0.415|TWO_SIDED|95.0|-3.7|1.6|||Miettinen & Nurminen|||||1.6|-3.7|0.415
70961360|NCT00820027|141427930|OTHER||Difference in Percent|-0.1||||0.965|TWO_SIDED|95.0|-3.0|2.8|||Miettinen & Nurminen|||||2.8|-3.0|0.965
70961361|NCT00820027|141427930|OTHER||Difference in Percent|2.3||||0.227|TWO_SIDED|95.0|-1.3|8.4|||Miettinen & Nurminen|||Placebo vs. Ibuprofen 1800 mg||8.4|-1.3|0.227
70961362|NCT00820027|141427930|OTHER||Difference in Percent|0.8||||0.437|TWO_SIDED|95.0|-1.7|3.6|||Miettinen & Nurminen|||||3.6|-1.7|0.437
70961363|NCT00820027|141427931|OTHER||Difference in Percent|0.5||||0.806|TWO_SIDED|95.0|-5.3|4.5|||Miettinen & Nurminen|||||4.5|-5.3|0.806
70961364|NCT00820027|141427931|OTHER||Difference in Percent|-1.8||||0.278|TWO_SIDED|95.0|-7.4|1.4|||Miettinen & Nurminen|||||1.4|-7.4|0.278
70961365|NCT00820027|141427931|OTHER||Difference in Percent|0.1||||0.971|TWO_SIDED|95.0|-5.7|3.9|||Miettinen & Nurminen|||||3.9|-5.7|0.971
70961366|NCT00820027|141427931|OTHER||Difference in Percent|0.5||||0.786|TWO_SIDED|95.0|-3.2|4.2|||Miettinen & Nurminen|||||4.2|-3.2|0.786
70961367|NCT00820027|141427931|OTHER||Difference in Percent|-1.8||||0.184|TWO_SIDED|95.0|-5.2|1.0|||Miettinen & Nurminen|||||1.0|-5.2|0.184
70961368|NCT00820027|141427931|OTHER||Difference in Percent|-0.1||||0.971|TWO_SIDED|95.0|-3.9|5.7|||Miettinen & Nurminen|||Placebo vs. Ibuprofen 1800 mg||5.7|-3.9|0.971
70961369|NCT00820027|141427931|OTHER||Difference in Percent|-2.3||||0.113|TWO_SIDED|95.0|-5.8|0.6|||Miettinen & Nurminen|||||0.6|-5.8|0.113
70961370|NCT00820027|141427932|OTHER||Difference in Percent|-5.3||||0.365|TWO_SIDED|95.0|-17.0|6.0|||Miettinen & Nurminen|||||6.0|-17.0|0.365
70961371|NCT00820027|141427932|OTHER||Difference in Percent|-7.2||||0.222||95.0|-18.8|4.2|||Miettinen & Nurminen|||||4.2|-18.8|0.222
70961372|NCT00820027|141427932|OTHER||Difference in Percent|-5.5||||0.349|TWO_SIDED|95.0|-17.2|5.9|||Miettinen & Nurminen|||||5.9|-17.2|0.349
70961373|NCT00820027|141427932|OTHER||Difference in Percent|0.2||||0.965|TWO_SIDED|95.0|-8.7|9.0|||Miettinen & Nurminen|||||9.0|-8.7|0.965
70961374|NCT00820027|141427932|OTHER||Difference in Percent|-1.6||||0.718|TWO_SIDED|95.0|-10.5|7.3|||Miettinen & Nurminen|||||7.3|-10.5|0.718
70961375|NCT00820027|141427932|OTHER||Difference in Percent|5.5||||0.349|TWO_SIDED|95.0|-5.9|17.2|||Miettinen & Nurminen|||Placebo vs. Ibuprofen 1800 mg||17.2|-5.9|0.349
70961376|NCT00820027|141427932|OTHER||Difference in Percent|1.8||||0.684|TWO_SIDED|95.0|-7.0|10.6|||Miettinen & Nurminen|||||10.6|-7.0|0.684
70961377|NCT00820027|141427933|NON_INFERIORITY|Non-inferiority reached if the upper bound of the 95% confidence interval of the between-treatment difference (Etoricoxib minus Ibuprofen) in LS means is no greater than 1.|Difference in Least Squares Mean|-0.04|||||TWO_SIDED|95.0|-0.36|0.27||||||||0.27|-0.36|
70961378|NCT00820027|141427933|NON_INFERIORITY|Non-inferiority reached if the upper bound of the 95% confidence interval of the between-treatment difference (Etoricoxib minus Ibuprofen) in LS means is no greater than 1.|Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.42|0.22||||||||0.22|-0.42|
70961379|NCT00820027|141427934|OTHER|Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.|Between-Treatment Ratio|1.05|||||TWO_SIDED|95.0|0.89|1.23|||||A ratio \<1 indicates a beneficial effect of Etoricoxib.|||1.23|0.89|
70961380|NCT00820027|141427934|OTHER|Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.|Between-Treatment Ratio|1.01|||||TWO_SIDED|95.0|0.85|1.18|||||A ratio \<1 indicates a beneficial effect of Etoricoxib.|||1.18|0.85|
70961381|NCT00820027|141427934|OTHER|Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.|Between-Treatment Ratio|1.04|||||TWO_SIDED|95.0|0.89|1.23|||||A ratio \<1 indicates a beneficial effect of Etoricoxib.|||1.23|0.89|
70961382|NCT01776424|141427990|SUPERIORITY||Hazard Ratio (HR)|0.76||||4e-05|TWO_SIDED|95.0|0.66|0.86||Independent DSMB recommended to stop rivaroxaban/aspirin arms on 06FEB2017. At first interim analysis(\~50% events) the log-rank test statistic for one primary comparison had crossed the modified Haybittle-Peto boundary(z=4) consistently over 3 months|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||0.86|0.66|0.00004
70961383|NCT01776424|141427990|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.1149|TWO_SIDED|95.0|0.79|1.03|||Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||1.03|0.79|0.11490
70961384|NCT01776424|141427991|SUPERIORITY||Hazard Ratio (HR)|1.7|||<|1e-05|TWO_SIDED|95.0|1.4|2.05|||Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||2.05|1.40|<0.00001
70961385|NCT01776424|141427991|SUPERIORITY||Hazard Ratio (HR)|1.51||||3e-05|TWO_SIDED|95.0|1.25|1.84|||Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||1.84|1.25|0.00003
70961386|NCT01776424|141427992|SUPERIORITY||Hazard Ratio (HR)|0.72||||1e-05|TWO_SIDED|95.0|0.63|0.83||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||0.83|0.63|0.00001
70961387|NCT01776424|141427992|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.06437|TWO_SIDED|95.0|0.77|1.01||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||1.01|0.77|0.06437
70961388|NCT01776424|141427993|SUPERIORITY||Hazard Ratio (HR)|0.74||||1e-05|TWO_SIDED|95.0|0.65|0.85||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||0.85|0.65|0.00001
70961389|NCT01776424|141427993|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.03995||95.0|0.77|0.99||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||0.99|0.77|0.03995
70961390|NCT01776424|141427994|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.01062|TWO_SIDED|95.0|0.71|0.96||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||0.96|0.71|0.01062
70961391|NCT01776424|141427994|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.66418|TWO_SIDED|95.0|0.84|1.12||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||1.12|0.84|0.66418
70961392|NCT00186069|141428014|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.68|TWO_SIDED|95.0|0.77|1.86|||Fisher Exact|||||1.86|0.77|0.68
70961393|NCT00186069|141428015|SUPERIORITY_OR_OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||||||0.52
70961394|NCT00186069|141428016|SUPERIORITY_OR_OTHER|||||||0.95|||||||Fisher Exact|||||||0.95
70961395|NCT00752622|141428108|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||Comparison of Infliximab from Induction baseline to evaluation Week 10.||||<.0001
70961396|NCT00752622|141428108|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||Comparison of Infliximab from Induction baseline to Week 30 of the Observational Phase.||||<.0001
70961397|NCT00752622|141428108|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||Comparison of Infliximab from Induction baseline to Week 54 of the Observational Phase.||||<.0001
70961398|NCT00267631|141428130|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Chi-squared|||||||.026
70961399|NCT00504881|141428192|SUPERIORITY_OR_OTHER||Percent Reduction over Placebo|7.3|||=|0.125|TWO_SIDED|95.0|-2.2|15.9|||ANCOVA|||ANCOVA on log-transformed partial seizure frequency per week over the treatment period, with log-transformed baseline seizure frequency per week as covariate, and including terms for treatment and stratification factors.||15.9|-2.2|=0.125
70961400|NCT01777269|141428214|SUPERIORITY_OR_OTHER||Adjusted mean difference|-8.0|||<|0.001|TWO_SIDED|95.0|-10.22|-5.79|||mixed-model repeated-measures|||||-5.79|-10.22|<0.001
70961401|NCT01777269|141428215|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.11|||<|0.001|TWO_SIDED|95.0|-6.01|-2.21|||mixed-model repeated-measures||Month 1|||-2.21|-6.01|<0.001
70961402|NCT01777269|141428215|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.43|||<|0.001|TWO_SIDED|95.0|-8.45|-4.41|||Adjusted mean difference||Month 3|||-4.41|-8.45|<0.001
70961403|NCT01777269|141428215|SUPERIORITY_OR_OTHER||Adjusted mean difference|-9.04|||<|0.001|TWO_SIDED|95.0|-11.31|-6.77|||mixed-model repeated-measures||Month 6|||-6.77|-11.31|<0.001
70961404|NCT01777269|141428215|SUPERIORITY_OR_OTHER||Adjusted mean difference|-8.82|||<|0.001|TWO_SIDED|95.0|-10.96|-6.67|||mixed-model repeated-measures||Month 9|||-6.67|-10.96|<0.001
70961405|NCT01777269|141428217|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.2||||0.37|TWO_SIDED|95.0|-0.62|0.23|||mixed-model repeated-measures||Month 1|||0.23|-0.62|0.37
70961406|NCT01777269|141428217|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.24||||0.33|TWO_SIDED|95.0|-0.71|0.24|||mixed-model repeated-measures||Month 3|||0.24|-0.71|0.33
70961407|NCT01777269|141428217|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.37||||0.16|TWO_SIDED|95.0|-0.88|0.15|||mixed-model repeated-measures||Month 6|||0.15|-0.88|0.16
70961408|NCT01777269|141428217|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.68||||0.009|TWO_SIDED|95.0|-1.19|-0.17|||mixed-model repeated-measures||Month 9|||-0.17|-1.19|0.009
70961409|NCT01777269|141428217|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.46||||0.091|TWO_SIDED|95.0|-0.99|0.07|||mixed-model repeated-measures||Month 12|||0.07|-0.99|0.091
70961410|NCT01777269|141428218|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.89|||<|0.001|TWO_SIDED|95.0|-4.07|-1.7|||mixed-model repeated-measures||Month 1|||-1.70|-4.07|<0.001
70961411|NCT01777269|141428218|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.24|||<|0.001|TWO_SIDED|95.0|-6.59|-3.9|||mixed-model repeated-measures||Month 3|||-3.90|-6.59|<0.001
70961412|NCT01777269|141428218|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.82|||<|0.001|TWO_SIDED|95.0|-8.3|-5.34|||mixed-model repeated-measures||Month 6|||-5.34|-8.30|<0.001
70961413|NCT01777269|141428218|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.05|||<|0.001|TWO_SIDED|95.0|-8.51|-5.59|||mixed-model repeated-measures||Month 9|||-5.59|-8.51|<0.001
70961414|NCT01777269|141428218|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.92|||<|0.001|TWO_SIDED|95.0|-8.47|-5.38|||mixed-model repeated-measures||Month 12|||-5.38|-8.47|<0.001
70961415|NCT01777269|141428219|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.94||||0.012|TWO_SIDED|95.0|-1.67|-0.21|||mixed-model repeated-measures||Month 1|||-0.21|-1.67|0.012
70961416|NCT01777269|141428219|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.93||||0.017|TWO_SIDED|95.0|-1.69|-0.17|||mixed-model repeated-measures||Month 3|||-0.17|-1.69|0.017
70961417|NCT01777269|141428219|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.73|||<|0.001|TWO_SIDED|95.0|-2.57|-0.88|||mixed-model repeated-measures||Month 6|||-0.88|-2.57|<0.001
70961418|NCT01777269|141428219|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.15||||0.009|TWO_SIDED|95.0|-2.01|-0.3|||mixed-model repeated-measures||Month 9|||-0.30|-2.01|0.009
70961419|NCT01777269|141428219|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.83||||0.047|TWO_SIDED|95.0|-1.65|-0.01|||mixed-model repeated-measures||Month 12|||-0.01|-1.65|0.047
70961420|NCT01777269|141428220|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.65|||<|0.001|TWO_SIDED|95.0|-2.45|-0.85|||mixed-model repeated-measures||Week 2|||-0.85|-2.45|<0.001
70961421|NCT01777269|141428220|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.55||||0.24|TWO_SIDED|95.0|-1.47|0.37|||mixed-model repeated-measures||Month 1|||0.37|-1.47|0.24
70881147|NCT00362115|141247124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.6|||<|0.0001|TWO_SIDED|95.0|-10.87|-4.3||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.30|-10.87|< 0.0001
70881148|NCT00362115|141247124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.5519|TWO_SIDED|95.0|-2.11|3.95||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.95|-2.11|0.5519
70881149|NCT00362115|141247124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.3938|TWO_SIDED|95.0|-4.54|1.79||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.79|-4.54|0.3938
70881150|NCT00362115|141247124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.1949|TWO_SIDED|95.0|-5.21|1.07||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.07|-5.21|0.1949
70961422|NCT01777269|141428220|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.27||||0.006|TWO_SIDED|95.0|-2.19|-0.36|||mixed-model repeated-measures||Month 3|||-0.36|-2.19|0.006
70961423|NCT01777269|141428220|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.73|||<|0.001|TWO_SIDED|95.0|-2.74|-0.72|||mixed-model repeated-measures||Month 6|||-0.72|-2.74|<0.001
70961424|NCT01777269|141428220|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.34||||0.013|TWO_SIDED|95.0|-2.4|-0.28|||mixed-model repeated-measures||Month 9|||-0.28|-2.40|0.013
70961425|NCT01777269|141428220|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.97|||<|0.001|TWO_SIDED|95.0|-3.12|-0.83|||mixed-model repeated-measures||Month 12|||-0.83|-3.12|<0.001
70961426|NCT01777269|141428221|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.4||||0.036|TWO_SIDED|95.0|-0.78|-0.03|||mixed-model repeated-measures||Week 2|||-0.03|-0.78|0.036
70961427|NCT01777269|141428221|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.0||||1|TWO_SIDED|95.0|-0.37|0.37|||mixed-model repeated-measures||Month 1|||0.37|-0.37|1.00
70961428|NCT01777269|141428221|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.26||||0.21|TWO_SIDED|95.0|-0.67|0.15|||mixed-model repeated-measures||Month 3|||0.15|-0.67|0.21
70961429|NCT01777269|141428221|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.62||||0.009|TWO_SIDED|95.0|-1.09|-0.15|||mixed-model repeated-measures||Month 6|||-0.15|-1.09|0.009
70961430|NCT01777269|141428221|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.45||||0.056|TWO_SIDED|95.0|-0.91|0.01|||mixed-model repeated-measures||Month 9|||0.01|-0.91|0.056
70961431|NCT01777269|141428221|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.58||||0.023|TWO_SIDED|95.0|-1.08|-0.08|||mixed-model repeated-measures||Month 12|||-0.08|-1.08|0.023
70961432|NCT01777269|141428222|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.0|||<|0.001|TWO_SIDED|95.0|-3.89|-2.1|||mixed-model repeated-measures||Week 2|||-2.10|-3.89|<0.001
70961433|NCT01777269|141428222|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.1|||<|0.001|TWO_SIDED|95.0|-3.15|-1.06|||mixed-model repeated-measures||Month 1|||-1.06|-3.15|<0.001
70961434|NCT01777269|141428222|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.11|||<|0.001|TWO_SIDED|95.0|-3.25|-0.98|||mixed-model repeated-measures||Month 3|||-0.98|-3.25|<0.001
70961435|NCT01777269|141428222|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.53|||<|0.001|TWO_SIDED|95.0|-3.76|-1.3|||mixed-model repeated-measures||Month 6|||-1.30|-3.76|<0.001
70961436|NCT01777269|141428222|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.3||||0.042|TWO_SIDED|95.0|-2.56|-0.05|||mixed-model repeated-measures||Month 9|||-0.05|-2.56|0.042
70961437|NCT01777269|141428222|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.51|||<|0.001|TWO_SIDED|95.0|-4.87|-2.14|||mixed-model repeated-measures||Month 12|||-2.14|-4.87|<0.001
70961438|NCT01777269|141428223|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.78|||<|0.001|TWO_SIDED|95.0|-10.07|-5.49|||mixed-model repeated-measures||Par. with IPSS change from baseline \>=2 points improvement at any time post-baseline visit|||-5.49|-10.07|<0.001
70961439|NCT01777269|141428223|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.39|||<|0.001|TWO_SIDED|95.0|-9.79|-4.99|||mixed-model repeated-measures||Par. with IPSS change from baseline \>=3 points improvement at any time post-baseline visit|||-4.99|-9.79|<0.001
70961440|NCT01777269|141428224|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.79|||<|0.001|TWO_SIDED|95.0|-10.22|-5.35|||mixed-model repeated-measures||Par. with IPSS change from baseline \>=25 points improvement at any time post-baseline visit|||-5.35|-10.22|<0.001
70961441|NCT00803270|141428228|SUPERIORITY_OR_OTHER||Difference of proportions|0.08|STANDARD_ERROR_OF_MEAN|0.19||0.99|TWO_SIDED|95.0|-0.28|0.44|||Fisher Exact|||||0.44|-0.28|0.99
70961442|NCT00803270|141428229|SUPERIORITY_OR_OTHER||difference of proportions|0.45|STANDARD_ERROR_OF_MEAN|0.21||0.08|TWO_SIDED|95.0|0.03|0.87||Fisher's Exact Test of equality of percent meeting optimal outcome.|Fisher Exact|||||0.87|0.03|0.08
70961443|NCT00593957|141428240|SUPERIORITY_OR_OTHER||||||<|0.4|||||||t-test, 2 sided|||||||<0.40
70961444|NCT00593957|141428240|SUPERIORITY_OR_OTHER||||||<|0.62||95.0|||||t-test, 2 sided|||||||<0.62
70961445|NCT00593957|141428240|SUPERIORITY_OR_OTHER||||||<|0.38||95.0|||||t-test, 2 sided|||||||<0.38
70961446|NCT00593957|141428242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.38|||<|0.1|||||||ANOVA|||Null hypothesis is that there would be no significant difference in social abilities as measured by the SSI score in this treatment group baseline to 6 months post-treatment.||||<0.10
70961447|NCT00593957|141428242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5|||<|0.5|||||||ANOVA|||||||<0.50
70961448|NCT00593957|141428242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|||<|0.48|||||||ANOVA|||||||<0.48
70961449|NCT00593957|141428243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.947|||<|0.05|||||||ANOVA|||||||<0.05
70961450|NCT01786239|141428248|SUPERIORITY_OR_OTHER|||||||0.0493|||||||Mixed Models Analysis|||||||0.0493
70961451|NCT02511678|141428249|SUPERIORITY|||||||0.0746||||||The 1-sided p-value was based on a t-test against a performance goal of -2.|t-test, 1 sided|||||||0.0746
70881151|NCT00362115|141247124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.0732|TWO_SIDED|95.0|-6.21|0.28||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.28|-6.21|0.0732
70881152|NCT00362115|141247124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.3669|TWO_SIDED|95.0|-4.59|1.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.70|-4.59|0.3669
70881153|NCT00362115|141247125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2||||0.0019|TWO_SIDED|95.0|-14.94|-3.41||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.41|-14.94|0.0019
70881154|NCT00362115|141247125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.2||||0.0008|TWO_SIDED|95.0|-16.15|-4.26||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.26|-16.15|0.0008
70881155|NCT00362115|141247125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.9||||0.004|TWO_SIDED|95.0|-14.88|-2.85||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.85|-14.88|0.0040
70881156|NCT00362115|141247125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.6||||0.0001|TWO_SIDED|95.0|-18.96|-6.22||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.22|-18.96|0.0001
70881157|NCT00362115|141247125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9||||0.0004|TWO_SIDED|95.0|-16.85|-4.89||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.89|-16.85|0.0004
70881158|NCT00362115|141247125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.3499|TWO_SIDED|95.0|-8.39|2.98||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.98|-8.39|0.3499
70881159|NCT00362115|141247125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7||||0.2115|TWO_SIDED|95.0|-9.61|2.14||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.14|-9.61|0.2115
70881160|NCT00362115|141247125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.4279|TWO_SIDED|95.0|-8.34|3.54||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.54|-8.34|0.4279
70881161|NCT00362115|141247125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||0.0566|TWO_SIDED|95.0|-12.41|0.17||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.17|-12.41|0.0566
70881162|NCT00362115|141247125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.1435|TWO_SIDED|95.0|-10.3|1.5||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.50|-10.30|0.1435
70881163|NCT00362115|141247126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.1162|TWO_SIDED|95.0|-6.16|0.68||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.68|-6.16|0.1162
70881164|NCT00362115|141247126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.2494|TWO_SIDED|95.0|-5.69|1.48||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.48|-5.69|0.2494
70881165|NCT00362115|141247126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.4247|TWO_SIDED|95.0|-5.01|2.12||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.12|-5.01|0.4247
70881166|NCT00362115|141247126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.3007|TWO_SIDED|95.0|-5.79|1.8||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.80|-5.79|0.3007
70881167|NCT00362115|141247126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.1195|TWO_SIDED|95.0|-6.67|0.77||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.77|-6.67|0.1195
70881168|NCT00362115|141247126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.2032|TWO_SIDED|95.0|-5.76|1.23||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.23|-5.76|0.2032
70881169|NCT00362115|141247126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.3787|TWO_SIDED|95.0|-5.27|2.01||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.01|-5.27|0.3787
70961452|NCT01295281|141428259|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"Two catheters were tested regarding subjects' perception when using them, in a cross over design. After using each catheter for 1 week the subjects were asked: Do you experience discomfort when using your catheter?, and the subjects were supposed to answer Yes or No. The hypothesis to be investigated was that the tolerability/perception was about the same for each type of catheter, i.e. the POBE 2.0 should be non-inferior compared to PVC. H0: p(disc. POBE - Yes) = p(disc. PVC - Yes)"||||||0.0066|||||||McNemar|||The size of the target population was estimated by calculating 95% Confidence Interval (CI) of a possible difference between the two catheter types. The width of the interval was decided on the proportion of patients who would prefer one or the other catheter. Max width was seen when both proportions were 0.5. A total of 90 evaluable subjects limited the maximum width to 0.41, which was considered narrow enough from a scientific point of view, why this sample size was used in the study.||||0.0066
70961453|NCT05461794|141428292|OTHER||Odds Ratio (OR)|2.1|||||TWO_SIDED|95.0|0.3|23.9|||||The crude odds ratio was estimated along with exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||23.9|0.3|
70961454|NCT05461794|141428292|OTHER||Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|-9.3|19.5|||||The risk difference was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||19.5|-9.3|
70961455|NCT05461794|141428294|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.45|1.61|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by PD-L1 tumor area positivity score (\>=10% versus \< 10%)|||1.61|0.45|
70961456|NCT05461794|141428295|OTHER||Odds Ratio (OR)|2.5|||||TWO_SIDED|95.0|0.9|6.8|||||The crude odds ratio was estimated along with exact unconditional 95% CIs constructed by the tail method based on the score statistics|||6.8|0.9|
70961457|NCT05461794|141428295|OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.3|3.7|||||The odds ratio was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||3.7|0.3|
70881170|NCT00362115|141247126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.5967|TWO_SIDED|95.0|-4.59|2.64||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.64|-4.59|0.5967
70881171|NCT00362115|141247126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.4345|TWO_SIDED|95.0|-5.36|2.31||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.31|-5.36|0.4345
70961458|NCT05461794|141428295|OTHER||Risk Difference (RD)|22.0|||||TWO_SIDED|95.0|-1.5|43.3|||||The risk difference was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||43.3|-1.5|
70961459|NCT05461794|141428295|OTHER||Risk Difference (RD)|0.9|||||TWO_SIDED|95.0|-24.5|28.4|||||The risk difference was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||28.4|-24.5|
70961460|NCT05461794|141428296|OTHER||Odds Ratio (OR)|3.9|||||TWO_SIDED|95.0|0.7|40.8|||||The crude odds ratio was estimated along with exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||40.8|0.7|
70961461|NCT05461794|141428296|OTHER||Odds Ratio (OR)|0.6|||||TWO_SIDED|95.0|0.1|2.9|||||The odds ratio was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||2.9|0.1|
70961462|NCT05461794|141428296|OTHER||Risk Difference (RD)|12.7|||||TWO_SIDED|95.0|-2.3|29.5|||||The risk difference was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||29.5|-2.3|
70961463|NCT05461794|141428296|OTHER||Risk Difference (RD)|-8.4|||||TWO_SIDED|95.0|-34.7|13.8|||||The risk difference was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||13.8|-34.7|
70961464|NCT05461794|141428297|OTHER||Hazard Ratio (HR)|0.53|||||TWO_SIDED|95.0|0.29|0.96|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by the selected stratification factors PD-L1 tumor area positivity score (\>=10% versus \< 10%)|||0.96|0.29|
70961465|NCT05461794|141428297|OTHER||Hazard Ratio (HR)|1.96|||||TWO_SIDED|95.0|0.79|4.82|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by the selected stratification factors PD-L1 tumor area positivity score (\>=10% versus \< 10%)|||4.82|0.79|
70881172|NCT00362115|141247126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.1954|TWO_SIDED|95.0|-6.24|1.28||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.28|-6.24|0.1954
70881173|NCT00335972|141247127|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was based on being able to detect noninferiority on both analgesia (pain score and opioids) and hemodynamic responses, and superiority on at least one of them with 90% power and significance level of 0.025 for each of noninferiority and superiority. For MAP with a noninferiority delta of 7.5 mmHg and expected the SD of 12, we needed a maximum of N= 65 per group. Incorporating the two interim and one final analyses, we thus planned a maximum sample size of N=71/group (N=142 total).|Mean Difference (Net)|-9.0|||<|0.001|TWO_SIDED|95.0|-13.0|-5.0||Noninferiority confidence intervals are 95% (alpha of 0.05/2=0.025 in direction of interest). Bonferroni correction was used for superiority testing and 97.5% CI were reported.|repeated measures ANOVA||mean difference: Dexmedetomidine arm - Remifentanil arm|||-5|-13|<0.001
70881174|NCT00335972|141247127|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.0|||<|0.001|TWO_SIDED|97.5|-13.0|-4.0||Bonferroni correction was used for superiority testing since superiority on either hemodynamics or pain control would be interpreted as Dex better than Remi (alpha=0.0125 = 0.025/2, 97.5% CI).|repeated measures ANOVA model||mean difference: dexmedetomidine arm - remifentanil arm|superiority test||-4|-13|<0.001
70961466|NCT05461794|141428298|OTHER||Odds Ratio (OR)|0.4|||||TWO_SIDED|95.0|0.1|2.7|||||The crude odds ratio was estimated along with exact unconditional 95% CIs constructed by the tail method based on the score statistics|||2.7|0.1|
70961467|NCT02684357|141428300|OTHER||Adjusted percentage difference|72.5|||<|0.001|TWO_SIDED|95.0|66.8|78.2||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||78.2|66.8|< 0.001
70961468|NCT02684357|141428301|OTHER||Adjusted percentage difference|78.5|||<|0.001|TWO_SIDED|95.0|72.4|84.5||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||84.5|72.4|< 0.001
70961469|NCT02684357|141428302|OTHER||Adjusted percentage difference|47.5|||<|0.001|TWO_SIDED|95.0|40.9|54.2||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||54.2|40.9|< 0.001
70961470|NCT02684357|141428303|OTHER||Adjusted percentage difference|48.2|||<|0.001|TWO_SIDED|95.0|41.9|54.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||54.6|41.9|< 0.001
70961471|NCT02684357|141428304|OTHER||Adjusted percentage difference|62.2|||<|0.001|TWO_SIDED|95.0|55.5|68.9||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||68.9|55.5|< 0.001
70961472|NCT02684357|141428305|OTHER||Adjusted percentage difference|31.2|||<|0.001|TWO_SIDED|95.0|25.7|36.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||36.6|25.7|< 0.001
70961473|NCT02684357|141428306|OTHER||Adjusted percentage difference|27.6|||<|0.001|TWO_SIDED|95.0|16.7|38.5||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||38.5|16.7|< 0.001
70961474|NCT02684357|141428307|OTHER||Adjusted percentage difference|22.3|||<|0.001|TWO_SIDED|95.0|12.0|32.5||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||32.5|12.0|< 0.001
70961475|NCT02684357|141428308|OTHER||Adjusted percentage difference|27.0|||<|0.001|TWO_SIDED|95.0|17.0|37.0||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||37.0|17.0|< 0.001
70961476|NCT02684357|141428309|OTHER||Adjusted percentage difference|26.3|||<|0.001|TWO_SIDED|95.0|16.1|36.4||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||36.4|16.1|< 0.001
70961477|NCT02684357|141428310|OTHER||Adjusted percentage difference|30.2|||<|0.001|TWO_SIDED|95.0|19.6|40.9||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||40.9|19.6|< 0.001
70881175|NCT00335972|141247128|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was based on being able to detect noninferiority on both analgesia (pain score and opioids) and hemodynamic responses, and superiority on at least one of them with 90% power and significance level of 0.025 for each of noninferiority and superiority. For VRS pain, the standard deviation (SD) was expected to be about 1.75, such that with a noninferiority delta of 1, we needed a maximum of N= 66 per group|Mean Difference (Net)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.7|-1.1||noninferiority confidence intervals are 95% (alpha of 0.05/2=0.025 in direction of interest).|repeated measures ANOVA model||mean difference: Dexmedetomidine arm - Remifentanil arm|||-1.1|-2.7|<0.001
70961478|NCT02684357|141428311|OTHER||Adjusted percentage difference|29.5|||<|0.001|TWO_SIDED|95.0|18.9|40.1||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||40.1|18.9|< 0.001
70961479|NCT02684357|141428312|OTHER||Adjusted percentage difference|29.5|||<|0.001|TWO_SIDED|95.0|18.9|40.1||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||40.1|18.9|< 0.001
70961480|NCT02684357|141428313|OTHER||Adjusted percentage difference|19.2|||<|0.001|TWO_SIDED|95.0|9.5|28.8||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||28.8|9.5|< 0.001
70961481|NCT02684357|141428314|OTHER||Adjusted percentage difference|18.0|||<|0.001|TWO_SIDED|95.0|7.8|28.3||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||28.3|7.8|< 0.001
70961482|NCT02684357|141428315|OTHER||Adjusted percentage difference|20.2|||<|0.001|TWO_SIDED|95.0|9.1|31.4||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||31.4|9.1|< 0.001
70961483|NCT02684357|141428316|OTHER||Mean Difference (Final Values)|-6.375|||<|0.001|TWO_SIDED|95.0|-7.102|-5.648|||van Elteren test|||P-value calculated by the van Elteren test stratified for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||-5.648|-7.102|< 0.001
70961484|NCT02684357|141428317|OTHER||Adjusted percentage difference|84.7|||<|0.001|TWO_SIDED|95.0|79.0|90.4||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||90.4|79.0|< 0.001
70881176|NCT00335972|141247128|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9|||<|0.001|TWO_SIDED|97.5|-2.8|-0.9||Bonferroni correction was used for superiority testing since superiority on either hemodynamics or pain control would be interpreted as Dex better than Remi (alpha=0.0125 = 0.025/2, 97.5% CI).|repeated measures ANOVA model||mean difference: dexmedetomidine arm - remifentanil arm|superiority test||-0.9|-2.8|<0.001
70961485|NCT02684357|141428318|OTHER||Adjusted percentage difference|29.1|||<|0.001|TWO_SIDED|95.0|18.5|39.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||39.6|18.5|< 0.001
70961486|NCT02684357|141428319|OTHER||Adjusted percentage difference|14.7||||0.001|TWO_SIDED|95.0|5.9|23.5||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||23.5|5.9|0.001
70961487|NCT03714425|141428327|SUPERIORITY||||||<|0.05||||||The primary research objective to measure perceived improvement in pain at three months was assessed using a two-sample t-test of PGIC scores between the two treatment groups using a type I error rate of 0.05 (two-sided).|t-test, 2 sided|Most of the analyses involved delta scores reflecting changes within subjects, though we compared PGIC raw scores rather than change scores.||||||<0.05
70961488|NCT03019796|141428329|OTHER|||||||0.04|||||||ANOVA|repeated measures||||||0.040
70961489|NCT03019796|141428330|OTHER|||||||0.054|||||||ANOVA|repeated measures||||||0.054
70961490|NCT03019796|141428331|OTHER|||||||0.04|||||||ANOVA|REPEATED MEASURES||||||0.040
70961491|NCT03019796|141428332|OTHER|||||||0.321|||||||ANOVA|REPEATED MEASURES||||||0.321
70961492|NCT03019796|141428333|OTHER|||||||0.401|||||||ANOVA|REPEATED MEASURES||||||0.401
70961493|NCT03019796|141428334|OTHER|||||||0.021|||||||ANOVA|REPEATED MEASURES||||||0.021
70961494|NCT03444324|141428343|NON_INFERIORITY|The primary efficacy analysis of this endpoint was to test non-inferiority in the Per-protocol Set. The final analysis was performed using a two-way analysis of variance (ANOVA). Non-inferiority was to be demonstrated if the upper confidence limit of the two-sided 95 % confidence interval (CI) for the difference in the least squares mean (LSM) was less than the non-inferiority margin (150 mL).|Difference in LSM|-279.43|||<|0.001|TWO_SIDED|95.0|-552.38|-6.48||p-value from Van Elteren test, stratified by predictive blood loss (\> 1,000 mL to = 2,000 mL and \>2,000 mL)|Van Elteren test|||||-6.48|-552.38|<0.001
70961495|NCT03444324|141428344|OTHER||Difference in response rate|38.1|||<|0.001|TWO_SIDED|95.0|26.0|50.3|||Cochran-Mantel-Haenszel|P-value is from a Cochran-Mantel-Haenszel model stratified by predictive blood loss (\> 1,000 mL to ≤ 2,000 mL and \> 2,000 mL).||||50.3|26|<0.001
70961496|NCT03444324|141428345|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
70961497|NCT03444324|141428351|OTHER||Difference in LSM|-15.5|||<|0.831|TWO_SIDED|95.0|-157.83|126.88|||ANOVA|||||126.88|-157.83|<0.831
70961498|NCT03444324|141428352|OTHER||Difference in LSM|12.4|||=|0.809|TWO_SIDED|95.0|-88.84|113.66|||ANOVA|||||113.66|-88.84|=0.809
70961499|NCT03444324|141428353|OTHER||Difference in proportion|-4.8|||=|0.022|TWO_SIDED|95.0|-8.9|-0.7|||Cochran-Mantel-Haenszel|||||-0.7|-8.9|=0.022
70961500|NCT02425644|141428369|SUPERIORITY||Rate ratio|0.695||||0.0003|TWO_SIDED|99.0|0.536|0.902|||Negative binomial regression model|||||0.902|0.536|0.0003
70961501|NCT02425644|141428370|SUPERIORITY||Mean Difference (Final Values)|-3.57||||0.0019|TWO_SIDED|95.0|-5.83|-1.32|||Mixed Models Analysis|||||-1.32|-5.83|0.0019
70961502|NCT02425644|141428371|SUPERIORITY||Rate Ratio|0.444|||<|0.0001|TWO_SIDED|95.0|0.364|0.542|||Negative binomial regression model|||||0.542|0.364|<.0001
70961503|NCT02425644|141428372|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.2939|TWO_SIDED|95.0|0.58|1.18|||Log Rank|||||1.18|0.58|0.2939
70961504|NCT02425644|141428373|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.372|TWO_SIDED|95.0|0.57|1.24|||Log Rank|||||1.24|0.57|0.3720
70961505|NCT01177787|141428376|OTHER||Mean Difference (Final Values)|-0.669|STANDARD_DEVIATION|0.03||0.503|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.503
70961506|NCT00402363|141428387|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.263|TWO_SIDED|95.0|0.9|1.46|||Regression, Cox|||||1.46|0.90|0.263
70961507|NCT00402363|141428388|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.64||||0.089|TWO_SIDED|95.0|0.92|2.92|||Log Rank|||||2.92|0.92|0.089
70961508|NCT00402363|141428388|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22||||0.081|TWO_SIDED|95.0|0.98|1.52|||Regression, Cox|||||1.52|0.98|0.081
70961509|NCT00402363|141428389|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.213|TWO_SIDED|95.0|0.91|1.49|||Regression, Cox|||||1.49|0.91|0.213
70961510|NCT00402363|141428389|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.5||||0.171|TWO_SIDED|95.0|0.83|2.69|||Log Rank|||||2.69|0.83|0.171
70961511|NCT00402363|141428390|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22||||0.082|TWO_SIDED|95.0|0.98|1.53|||Regression, Cox|||||1.53|0.98|0.082
70961512|NCT00402363|141428391|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12||||0.331|TWO_SIDED|95.0|0.89|1.4|||Regression, Cox|||||1.40|0.89|0.331
70961513|NCT00402363|141428391|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.297|TWO_SIDED|95.0|0.79|2.11|||Log Rank|||||2.11|0.79|0.297
70961514|NCT00402363|141428392|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.168|TWO_SIDED|95.0|0.94|1.42|||Regression, Cox|||||1.42|0.94|0.168
70961515|NCT00402363|141428393|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.27|TWO_SIDED|95.0|0.9|1.43|||Regression, Cox|||||1.43|0.90|0.270
70961516|NCT00402363|141428393|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.486|TWO_SIDED|95.0|0.73|1.95|||Log Rank|||||1.95|0.73|0.486
70961517|NCT00402363|141428394|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.167|TWO_SIDED|95.0|0.94|1.42|||Regression, Cox|||||1.42|0.94|0.167
70961518|NCT00402363|141428395|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.565|TWO_SIDED|95.0|0.81|1.47|||Regression, Cox|||||1.47|0.81|0.565
70961519|NCT00402363|141428395|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.68||||0.103|TWO_SIDED|95.0|0.89|3.15|||Log Rank|||||3.15|0.89|0.103
70961520|NCT00402363|141428396|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.185|TWO_SIDED|95.0|0.92|1.56|||Regression, Cox|||||1.56|0.92|0.185
70961521|NCT00402363|141428397|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12||||0.461|TWO_SIDED|95.0|0.83|1.51|||Regression, Cox|||||1.51|0.83|0.461
70961522|NCT00402363|141428397|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51||||0.206|TWO_SIDED|95.0|0.79|2.86|||Log Rank|||||2.86|0.79|0.206
70961523|NCT00402363|141428398|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.188|TWO_SIDED|95.0|0.92|1.57|||Regression, Cox|||||1.57|0.92|0.188
70961524|NCT00402363|141428399|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.07||||0.29|TWO_SIDED|95.0|-0.09|2.08|||non-parametric ANCOVA|||||2.08|-0.09|0.290
70961525|NCT00402363|141428399|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.063||||0.479|TWO_SIDED|95.0|-0.08|2.02|||Wilcoxon (Mann-Whitney)|||||2.02|-0.08|0.479
70961526|NCT00402363|141428399|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.039||||0.218|TWO_SIDED|95.0|-0.06|1.49|||non-parametric ANCOVA|||||1.49|-0.06|0.218
70961527|NCT00402363|141428400|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.321||||0.218|TWO_SIDED|95.0|-0.18|2.21|||non-parametric ANCOVA|||||2.21|-0.18|0.218
70961528|NCT00402363|141428400|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.216||||0.188|TWO_SIDED|95.0|-0.14|3.14|||Wilcoxon (Mann-Whitney)|||||3.14|-0.14|0.188
70961529|NCT00402363|141428400|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.181||||0.097|TWO_SIDED|95.0|-0.1|2.1|||non-parametric ANCOVA|||||2.10|-0.10|0.097
70961530|NCT00402363|141428401|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.242||||0.239|TWO_SIDED|95.0|-0.19|2.17|||non-parametric ANCOVA|||||2.17|-0.19|0.239
70961531|NCT00402363|141428401|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.249||||0.152|TWO_SIDED|95.0|-0.09|4.31|||Wilcoxon (Mann-Whitney)|||||4.31|-0.09|0.152
70961532|NCT00402363|141428401|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.2||||0.094|TWO_SIDED|95.0|-0.08|2.11|||non-parametric ANCOVA|||||2.11|-0.08|0.094
70961533|NCT02634346|141428417|SUPERIORITY||Least square mean difference|-6.4|STANDARD_ERROR_OF_MEAN|1.83|<|0.001|TWO_SIDED|95.0|-10.0|-2.8|||Mixed Models Analysis|Mixed model for repeated measures is based on observed data without imputation of missing data.||||-2.8|-10.0|<0.001
70961534|NCT02634346|141428417|SUPERIORITY||Least square mean difference|-5.3|STANDARD_ERROR_OF_MEAN|1.84||0.004|TWO_SIDED|95.0|-8.9|-1.7|||Mixed Models Analysis|Mixed model for repeated measures is based on observed data without imputation of missing data.||||-1.7|-8.9|0.004
70961535|NCT02634346|141428418|SUPERIORITY||Least square mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.118||0.002|TWO_SIDED|95.0|-0.61|-0.14|||Mixed Models Analysis|Mixed model for repeated measures is based on observed data without imputation of missing data.||||-0.14|-0.61|0.002
70961536|NCT02634346|141428418|SUPERIORITY||Least square mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.118|<|0.001|TWO_SIDED|95.0|-0.67|-0.2|||Mixed Models Analysis|Mixed model for repeated measures is based on observed data without imputation of missing data.||||-0.20|-0.67|<0.001
70961537|NCT01346488|141428420|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
70961538|NCT01346488|141428420|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
70961539|NCT01346488|141428420|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
70961540|NCT01346488|141428420|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
70961541|NCT01346488|141428420|SUPERIORITY_OR_OTHER|||||||1||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||1.0000
70961542|NCT01346488|141428420|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
70961543|NCT01346488|141428421|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
70961544|NCT01346488|141428421|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
70961545|NCT01346488|141428421|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
70961546|NCT01346488|141428421|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
70961547|NCT01346488|141428421|SUPERIORITY_OR_OTHER|||||||0.0054||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||0.0054
70961548|NCT01346488|141428421|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
70961549|NCT01346488|141428422|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||<0.0001
70961550|NCT01346488|141428422|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||<0.0001
70961551|NCT01346488|141428422|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
70961552|NCT01346488|141428422|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||<0.0001
70961553|NCT01346488|141428422|SUPERIORITY_OR_OTHER|||||||0.0592||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||0.0592
70961554|NCT01346488|141428422|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
70961555|NCT01346488|141428423|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
70961556|NCT01346488|141428423|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||<0.0001
70961557|NCT01346488|141428423|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||<0.0001
70961558|NCT01346488|141428423|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||<0.0001
70961559|NCT01346488|141428423|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||< 0.0001
70961560|NCT01346488|141428423|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
70961561|NCT01346488|141428424|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
70961562|NCT01346488|141428424|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
70961563|NCT01346488|141428424|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
70961564|NCT01346488|141428424|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
70961565|NCT01346488|141428424|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||< 0.0001
70961566|NCT01346488|141428424|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
70961567|NCT01346488|141428425|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 12 (Remission)||||<0.0001
70961568|NCT01346488|141428425|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 24 (Remission)||||< 0.0001
70961569|NCT01346488|141428425|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 36 (Remission)||||< 0.0001
70961570|NCT01346488|141428425|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 48 (Remission)||||< 0.0001
70961571|NCT01346488|141428425|SUPERIORITY_OR_OTHER||||||=|0.0005||||||P-value adjusted for multiplicity|McNemar|||at discontinuation of ADA therapy (Remission)||||= 0.0005
70961572|NCT01346488|141428425|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at final assessment (Remission)||||< 0.0001
70961573|NCT01346488|141428426|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
70961574|NCT01346488|141428426|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
70961575|NCT01346488|141428426|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
70961576|NCT01346488|141428426|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
70961577|NCT01346488|141428426|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||< 0.0001
70961578|NCT01346488|141428426|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
70961579|NCT01346488|141428427|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 12 (Remission)||||< 0.0001
70961580|NCT01346488|141428427|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 24 (Remission)||||< 0.0001
70961581|NCT01346488|141428427|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 36 (Remission)||||< 0.0001
70961582|NCT01346488|141428427|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 48 (Remission)||||< 0.0001
70961583|NCT01346488|141428427|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at discontinuation of ADA therapy (Remission)||||< 0.0001
70961584|NCT01346488|141428427|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at final assessment (Remission)||||< 0.0001
70961585|NCT01346488|141428428|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
70961586|NCT01346488|141428428|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
70961587|NCT01346488|141428428|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
70961588|NCT01346488|141428428|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
70961589|NCT01346488|141428428|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||< 0.0001
70961590|NCT01346488|141428428|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
70881177|NCT00335972|141247129|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was based on being able to detect noninferiority on both analgesia (pain score and opioids) and hemodynamic responses, and superiority on at least one of them with 90% power and significance level of 0.025 for each of noninferiority and superiority.we needed a maximum of N= 65 per group. We assumed for opioids that the coefficient of variation (SD/mean) was about 0.4, resulting in a similar sample size (64/group) with noninferiority deltas of 20% of the observed mean|Mean Difference (Net)|-5.0|||<|0.001|TWO_SIDED|95.0|-10.0|-5.0||noninferiority confidence intervals are 95% (alpha of 0.05/2=0.025 in direction of interest)|Wilcoxon (Mann-Whitney)||mean difference: Dexmedetomidine arm - Remifentanil|||-5|-10|<0.001
70881178|NCT00335972|141247129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.0|||<|0.001|TWO_SIDED|97.5|-10.0|-3.0||Bonferroni correction was used for superiority testing since superiority on either hemodynamics or pain control would be interpreted as Dex better than Remi (alpha=0.0125 = 0.025/2, 97.5% CI)|repeated measures ANOVA model||mean difference: dexmedetomidine arm - remifentanil arm|superiority||-3|-10|<0.001
70881179|NCT06002958|141247149|OTHER||Cohen's d|-0.29|||||TWO_SIDED|95.0|-0.815|0.255|||||Inner|||0.255|-0.815|
70881180|NCT06002958|141247149|OTHER||Cohen's d|0.02|||||TWO_SIDED|95.0|-0.503|0.545|||||Outer|||0.545|-0.503|
70881181|NCT06002958|141247149|OTHER||Cohen's d|-0.32|||||TWO_SIDED|95.0|-0.85|0.225|||||Individual|||0.225|-0.850|
70881182|NCT06002958|141247149|OTHER||Cohen's d|0.01|||||TWO_SIDED|95.0|-0.85|0.534|||||Process|||0.534|-0.850|
70881183|NCT05497284|141247155|OTHER|Probability (LTP001 is better than placebo)|Slope|-2.6|STANDARD_DEVIATION|2.07|||TWO_SIDED|80.0|-6.9|1.3||Probability that LTP001 is better than placebo is 10.3%|Baysesian random slope model|Bayesian random slope model to assess the difference in reduction rate (slope) in years between the treatment group and placebo group.||||1.3|-6.9|
70881184|NCT03878446|141247165|SUPERIORITY||Treatment difference|-1.4|||||TWO_SIDED|95.0|-3.2|0.4||||||||0.4|-3.2|
70881185|NCT03878446|141247165|SUPERIORITY||Treatment difference|0.7|||||TWO_SIDED|95.0|-1.1|2.5||||||||2.5|-1.1|
70881186|NCT03878446|141247165|SUPERIORITY||Treatment difference|-0.9|||||TWO_SIDED|95.0|-2.6|0.9||||||||0.9|-2.6|
70881187|NCT03878446|141247165|SUPERIORITY||Treatment difference|-0.6|||||TWO_SIDED|95.0|-2.4|1.2||||||||1.2|-2.4|
70881188|NCT04365556|141247175|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance is p\<.05|ANCOVA|||||||<0.001
70881189|NCT04365556|141247176|SUPERIORITY|||||||0.69|||||||ANCOVA|||||||0.69
70881190|NCT04865354|141247206|NON_INFERIORITY|Noninferiority to be concluded if least squares means difference upper confidence limit is less than 0.05.|Least Squares Mean Difference|0.003|STANDARD_ERROR_OF_MEAN|0.0034|||ONE_SIDED|95.0||0.009||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.||LSM results based on general linear mixed effects model with terms for lens, period and sequence as fixed effects, subject as a random effect|Difference = PRECISION1 minus Clariti 1-Day|||0.009||
70881191|NCT00706641|141247209|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||paired t-test|||Tumor samples from 20 patients were analyzed for expression of pSFK. A paired t-Test was used to calculate the significance of the difference in expression levels before and after treatment.||||0.003
70881192|NCT00706641|141247212|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||paired t-test|||||||0.20
70881193|NCT00706641|141247213|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED||||||paired t-test|||||||0.42
70961591|NCT01346488|141428429|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 12 (Remission)||||< 0.0001
70961592|NCT01346488|141428429|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 24 (Remission)||||< 0.0001
70961593|NCT01346488|141428429|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 36 (Remission)||||< 0.0001
70961594|NCT01346488|141428429|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 48 (Remission)||||< 0.0001
70961595|NCT01346488|141428429|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at discontinuation of ADA therapy (Remission)||||< 0.0001
70961596|NCT01346488|141428429|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at final assessment (Remission)||||< 0.0001
70961597|NCT01346488|141428430|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
70961598|NCT01346488|141428430|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
70961599|NCT01346488|141428430|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
70961600|NCT01346488|141428430|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
70961601|NCT01346488|141428430|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||< 0.0001
70881194|NCT02515942|141247218|SUPERIORITY|Least squares mean for change from baseline from ANCOVA model with treatment, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal), baseline lesion size as covariates after multiple imputations.|Treatment Effect|-0.35||||0.0636|TWO_SIDED|80.0|-0.64|-0.06|||ANCOVA|||||-0.06|-0.64|0.0636
70961602|NCT01346488|141428430|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
70961603|NCT01346488|141428431|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 12 (Remission)||||< 0.0001
70961604|NCT01346488|141428431|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 24 (Remission)||||< 0.0001
70961605|NCT01346488|141428431|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 36 (Remission)||||< 0.0001
70961606|NCT01346488|141428431|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 48 (Remission)||||< 0.0001
70961607|NCT01346488|141428431|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at discontinuation of ADA therapy (Remission)||||< 0.0001
70881195|NCT02515942|141247218|SUPERIORITY||Treatment Effect|-0.29||||0.1019|TWO_SIDED|80.0|-0.59|0.0|||ANCOVA|||Least squares mean for change from baseline from ANCOVA model with treatment, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal), baseline lesion size as covariates after multiple imputations.||0.00|-0.59|0.1019
70881196|NCT02515942|141247218|SUPERIORITY||Treatment Effect|0.06||||0.5987|TWO_SIDED|80.0|-0.24|0.35|||ANCOVA|||Least squares mean for change from baseline from ANCOVA model with treatment, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal), baseline lesion size as covariates after multiple imputations.||0.35|-0.24|0.5987
70961608|NCT01346488|141428431|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at final assessment (Remission)||||< 0.0001
70961609|NCT01346488|141428432|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
70961610|NCT01346488|141428432|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
70961611|NCT01346488|141428432|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
70961612|NCT01346488|141428432|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
70961613|NCT01346488|141428432|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||< 0.0001
70961614|NCT01346488|141428432|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
70961615|NCT01008696|141428442|SUPERIORITY_OR_OTHER|||||||0.8849||||||Homozygous extensive metabolizer|Chi-squared|||||||0.8849
70961616|NCT01008696|141428442|SUPERIORITY_OR_OTHER|||||||0.865||||||Heterozygous extensive metabolizer|Chi-squared|||||||0.8650
70961617|NCT01008696|141428442|SUPERIORITY_OR_OTHER|||||||0.266||||||Poor metabolizer|Chi-squared|||||||0.2660
70961618|NCT01008696|141428443|SUPERIORITY_OR_OTHER|||||||0.7734||||||Change at Day 57: Heartburn|Wilcoxon rank-sum test|||||||0.7734
70961619|NCT01008696|141428443|SUPERIORITY_OR_OTHER|||||||0.6414||||||Change at Day 57: Regurgitation|Wilcoxon rank-sum test|||||||0.6414
70961620|NCT01008696|141428443|SUPERIORITY_OR_OTHER|||||||0.7809||||||Change at Day 57: Globus sensation|Wilcoxon rank-sum test|||||||0.7809
70961621|NCT01008696|141428443|SUPERIORITY_OR_OTHER|||||||0.8294||||||Change at Day 57: Chronic cough|Wilcoxon rank-sum test|||||||0.8294
70961622|NCT01008696|141428443|SUPERIORITY_OR_OTHER|||||||0.9874||||||Change at Day 57: Epigastric pain|Wilcoxon rank-sum test|||||||0.9874
70961623|NCT01008696|141428443|SUPERIORITY_OR_OTHER|||||||0.2776||||||Change at Day 57: Non cardiac chest pain|Wilcoxon rank-sum test|||||||0.2776
70961624|NCT01008696|141428443|SUPERIORITY_OR_OTHER|||||||0.6295||||||Change at Day 57: Hoarseness|Wilcoxon rank-sum test|||||||0.6295
70961625|NCT01008696|141428443|SUPERIORITY_OR_OTHER|||||||0.5335||||||Change at Day 57: Dysphagia|Wilcoxon rank-sum test|||||||0.5335
70961626|NCT01008696|141428443|SUPERIORITY_OR_OTHER|||||||0.8068||||||Change at Day 57: Abdominal distension|Wilcoxon rank-sum test|||||||0.8068
70961627|NCT01008696|141428443|SUPERIORITY_OR_OTHER|||||||0.568||||||Change at Day 57: Bloating|Wilcoxon rank-sum test|||||||0.5680
70961628|NCT01008696|141428443|SUPERIORITY_OR_OTHER|||||||0.5913||||||Change at Day 57: Post-prandial discomfort|Wilcoxon rank-sum test|||||||0.5913
70961629|NCT01008696|141428443|SUPERIORITY_OR_OTHER|||||||0.5566||||||Change at Day 57: Early satiety|Wilcoxon rank-sum test|||||||0.5566
70961630|NCT01008696|141428443|SUPERIORITY_OR_OTHER|||||||0.7047||||||Change at Day 57: Nausea|Wilcoxon rank-sum test|||||||0.7047
70961631|NCT01008696|141428443|SUPERIORITY_OR_OTHER|||||||0.3654||||||Change at Day 57: Vomitting|Wilcoxon rank-sum test|||||||0.3654
70961632|NCT01008696|141428443|SUPERIORITY_OR_OTHER|||||||0.531||||||Change at Day 57: Belching|Wilcoxon rank-sum test|||||||0.5310
70961633|NCT01008696|141428444|SUPERIORITY_OR_OTHER|||||||0.5032|||||||Wilcoxon rank-sum test|||||||0.5032
70961634|NCT00568321|141428445|SUPERIORITY||LS Mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.43||0.687|TWO_SIDED|90.0|-0.5|0.92|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Least square (LS) mean difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.92|-0.50|0.687
70961635|NCT00568321|141428445|SUPERIORITY||LS Mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.44||0.111|TWO_SIDED|90.0|-1.25|0.19|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||LS mean difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.19|-1.25|0.111
70961636|NCT00568321|141428446|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.41||0.399|TWO_SIDED|90.0|-0.79|0.58|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.58|-0.79|0.399
70961637|NCT00568321|141428446|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.42||0.189|TWO_SIDED|90.0|-1.06|0.32|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.32|-1.06|0.189
70961638|NCT00568321|141428446|SUPERIORITY||LS Mean Difference|0.35|STANDARD_ERROR_OF_MEAN|0.42||0.802|TWO_SIDED|90.0|-0.33|1.04|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.04|-0.33|0.802
70961639|NCT00568321|141428446|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.42||0.582|TWO_SIDED|90.0|-0.61|0.78|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.78|-0.61|0.582
70961640|NCT00568321|141428446|SUPERIORITY||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.42||0.789|TWO_SIDED|90.0|-0.36|1.04|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.04|-0.36|0.789
70961641|NCT00568321|141428446|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.42||0.29|TWO_SIDED|90.0|-0.94|0.47|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.47|-0.94|0.290
70961642|NCT00568321|141428446|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.44||0.568|TWO_SIDED|90.0|-0.65|0.81|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.81|-0.65|0.568
70961643|NCT00568321|141428446|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.45||0.116|TWO_SIDED|90.0|-1.27|0.2|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.20|-1.27|0.116
70961644|NCT00568321|141428446|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.46||0.218|TWO_SIDED|90.0|-1.11|0.4|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.40|-1.11|0.218
70961645|NCT00568321|141428446|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.46||0.261|TWO_SIDED|90.0|-1.06|0.47|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.47|-1.06|0.261
70961646|NCT00568321|141428446|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.48||0.252|TWO_SIDED|90.0|-1.11|0.47|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.47|-1.11|0.252
70961647|NCT00568321|141428446|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.49||0.182|TWO_SIDED|90.0|-1.26|0.36|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.36|-1.26|0.182
70961648|NCT00568321|141428447|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.39||0.683|TWO_SIDED|90.0|-0.46|0.84|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.84|-0.46|0.683
70961649|NCT00568321|141428447|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.4||0.31|TWO_SIDED|90.0|-0.85|0.46|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.46|-0.85|0.310
70961650|NCT00568321|141428447|SUPERIORITY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.37||0.668|TWO_SIDED|90.0|-0.46|0.78|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.78|-0.46|0.668
70961651|NCT00568321|141428447|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.38||0.165|TWO_SIDED|90.0|-0.99|0.26|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.26|-0.99|0.165
70961652|NCT00568321|141428447|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.36||0.546|TWO_SIDED|90.0|-0.55|0.64|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.64|-0.55|0.546
70961653|NCT00568321|141428447|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.36||0.19|TWO_SIDED|90.0|-0.92|0.28|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.28|-0.92|0.190
70961654|NCT00568321|141428447|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.35||0.467|TWO_SIDED|90.0|-0.6|0.55|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.55|-0.60|0.467
70961655|NCT00568321|141428447|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.35||0.153|TWO_SIDED|90.0|-0.94|0.22|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.22|-0.94|0.153
70961656|NCT00568321|141428447|SUPERIORITY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.41||0.632|TWO_SIDED|90.0|-0.54|0.81|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 5 to 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.81|-0.54|0.632
70961657|NCT00568321|141428447|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.41||0.094|TWO_SIDED|90.0|-1.22|0.14|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 5 to 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.14|-1.22|0.094
70961658|NCT00568321|141428447|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.39||0.468|TWO_SIDED|90.0|-0.68|0.61|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 5 to 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.61|-0.68|0.468
70961659|NCT00568321|141428447|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.39||0.167|TWO_SIDED|90.0|-1.03|0.27|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 5 to 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.27|-1.03|0.167
70961660|NCT00568321|141428447|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.37||0.394|TWO_SIDED|90.0|-0.72|0.52|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 5 to 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.52|-0.72|0.394
70961661|NCT00568321|141428447|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.38||0.138|TWO_SIDED|90.0|-1.04|0.21|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 5 to 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.21|-1.04|0.138
70961662|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.55||0.764|TWO_SIDED|90.0|-0.51|1.3|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.30|-0.51|0.764
70961663|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.55||0.75|TWO_SIDED|90.0|-0.54|1.28|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.28|-0.54|0.750
70961664|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|0.45||0.734|TWO_SIDED|90.0|-0.46|1.03|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.03|-0.46|0.734
70961665|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.45||0.514|TWO_SIDED|90.0|-0.73|0.77|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.77|-0.73|0.514
70961666|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|1.37|STANDARD_ERROR_OF_MEAN|1.89||0.765|TWO_SIDED|90.0|-1.76|4.5|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||4.50|-1.76|0.765
70961667|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|0.71|STANDARD_ERROR_OF_MEAN|1.9||0.646|TWO_SIDED|90.0|-2.43|3.86|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||3.86|-2.43|0.646
70961668|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.55||0.895|TWO_SIDED|90.0|-0.22|1.6|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.60|-0.22|0.895
70961669|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|0.42|STANDARD_ERROR_OF_MEAN|0.56||0.776|TWO_SIDED|90.0|-0.5|1.34|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.34|-0.50|0.776
70961670|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|0.72|STANDARD_ERROR_OF_MEAN|0.45||0.944|TWO_SIDED|90.0|-0.03|1.47|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.47|-0.03|0.944
70961671|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|0.45|STANDARD_ERROR_OF_MEAN|0.46||0.835|TWO_SIDED|90.0|-0.31|1.21|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.21|-0.31|0.835
70961672|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|3.23|STANDARD_ERROR_OF_MEAN|1.9||0.955|TWO_SIDED|90.0|0.09|6.37|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||6.37|0.09|0.955
70961673|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|2.31|STANDARD_ERROR_OF_MEAN|1.93||0.884|TWO_SIDED|90.0|-0.88|5.49|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||5.49|-0.88|0.884
70961674|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.56||0.737|TWO_SIDED|90.0|-0.57|1.28|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.28|-0.57|0.737
70961675|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.56||0.628|TWO_SIDED|90.0|-0.74|1.11|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.11|-0.74|0.628
70961676|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|0.67|STANDARD_ERROR_OF_MEAN|0.46||0.925|TWO_SIDED|90.0|-0.1|1.43|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.43|-0.10|0.925
70961677|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.46||0.518|TWO_SIDED|90.0|-0.75|0.79|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.79|-0.75|0.518
70961678|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|1.93||0.81|TWO_SIDED|90.0|-1.49|4.88|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||4.88|-1.49|0.810
70961679|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|1.94||0.6|TWO_SIDED|90.0|-2.72|3.7|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||3.70|-2.72|0.600
70961680|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.58||0.651|TWO_SIDED|90.0|-0.73|1.18|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.18|-0.73|0.651
70961681|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.59||0.342|TWO_SIDED|90.0|-1.21|0.73|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.73|-1.21|0.342
70961682|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|0.35|STANDARD_ERROR_OF_MEAN|0.48||0.768|TWO_SIDED|90.0|-0.44|1.14|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.14|-0.44|0.768
70961683|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.48||0.211|TWO_SIDED|90.0|-1.19|0.41|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.41|-1.19|0.211
70961684|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|0.56|STANDARD_ERROR_OF_MEAN|1.99||0.61|TWO_SIDED|90.0|-2.73|3.85|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||3.85|-2.73|0.610
70961685|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|-1.43|STANDARD_ERROR_OF_MEAN|2.02||0.241|TWO_SIDED|90.0|-4.76|1.91|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.91|-4.76|0.241
70961686|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.59||0.789|TWO_SIDED|90.0|-0.5|1.45|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.45|-0.50|0.789
70961687|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.6||0.57|TWO_SIDED|90.0|-0.88|1.09|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.09|-0.88|0.570
70961688|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|0.38|STANDARD_ERROR_OF_MEAN|0.49||0.782|TWO_SIDED|90.0|-0.43|1.19|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.19|-0.43|0.782
70961689|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.49||0.295|TWO_SIDED|90.0|-1.08|0.55|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.55|-1.08|0.295
70961690|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|1.75|STANDARD_ERROR_OF_MEAN|2.04||0.804|TWO_SIDED|90.0|-1.62|5.11|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||5.11|-1.62|0.804
70961691|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|0.82|STANDARD_ERROR_OF_MEAN|2.06||0.655|TWO_SIDED|90.0|-2.58|4.22|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||4.22|-2.58|0.655
70961692|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.6||0.409|TWO_SIDED|90.0|-1.13|0.86|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.86|-1.13|0.409
70961693|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.61||0.482|TWO_SIDED|90.0|-1.03|0.97|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.97|-1.03|0.482
70961694|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.5||0.592|TWO_SIDED|90.0|-0.71|0.94|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.94|-0.71|0.592
70961695|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.5||0.368|TWO_SIDED|90.0|-1.0|0.66|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.66|-1.00|0.368
70961696|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|2.08||0.396|TWO_SIDED|90.0|-3.98|2.88|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.88|-3.98|0.396
70961697|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|2.09||0.545|TWO_SIDED|90.0|-3.21|3.69|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||3.69|-3.21|0.545
70961698|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.62||0.486|TWO_SIDED|90.0|-1.04|1.0|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.00|-1.04|0.486
70961699|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.63||0.324|TWO_SIDED|90.0|-1.33|0.75|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.75|-1.33|0.324
70961700|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.51||0.563|TWO_SIDED|90.0|-0.76|0.92|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.92|-0.76|0.563
70961701|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.52||0.282|TWO_SIDED|90.0|-1.16|0.56|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.56|-1.16|0.282
70961702|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|2.12||0.409|TWO_SIDED|90.0|-3.99|3.01||P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.|Repeated Measures Model|||Week 16 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||3.01|-3.99|0.409
70961703|NCT00568321|141428448|SUPERIORITY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|2.17||0.293|TWO_SIDED|90.0|-4.76|2.39||P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.|Repeated Measures Model|||Week 16 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.39|-4.76|0.293
70961704|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.5||0.343|TWO_SIDED|90.0|-1.03|0.62|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.62|-1.03|0.343
70961705|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.51||0.576|TWO_SIDED|90.0|-0.75|0.94|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.94|-0.75|0.576
70961706|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.63||0.46|TWO_SIDED|90.0|-1.1|0.98|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.98|-1.10|0.460
70961707|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.63||0.435|TWO_SIDED|90.0|-1.15|0.94|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.94|-1.15|0.435
70881197|NCT02515942|141247219|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.0||||0.5029|TWO_SIDED|80.0|-0.11|0.11|||Mixed Models Analysis|||Change from baseline at Day 85||0.11|-0.11|0.5029
70881198|NCT02515942|141247219|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.04||||0.682|TWO_SIDED|80.0|-0.07|0.14|||Mixed Models Analysis|||Change from baseline at Day 85||0.14|-0.07|0.6820
70881199|NCT02515942|141247219|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.04||||0.6826|TWO_SIDED|80.0|-0.07|0.14|||Mixed Models Analysis|||Change from baseline at Day 85||0.14|-0.07|0.6826
70881200|NCT02515942|141247219|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.12||||0.1545|TWO_SIDED|80.0|-0.28|0.03|||Mixed Models Analysis|||Change from baseline at Day 169||0.03|-0.28|0.1545
70881201|NCT02515942|141247219|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.13||||0.1398|TWO_SIDED|80.0|-0.29|0.02|||Mixed Models Analysis|||Change from baseline at Day 169||0.02|-0.29|0.1398
70881202|NCT02515942|141247219|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.01||||0.4717|TWO_SIDED|80.0|-0.16|0.14|||Mixed Models Analysis|||Change from baseline at Day 169||0.14|-0.16|0.4717
70961708|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.56||0.104|TWO_SIDED|90.0|-1.62|0.22|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.22|-1.62|0.104
70961709|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.57||0.204|TWO_SIDED|90.0|-1.42|0.47|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.47|-1.42|0.204
70961710|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|0.75|STANDARD_ERROR_OF_MEAN|0.5||0.931|TWO_SIDED|90.0|-0.08|1.58|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.58|-0.08|0.931
70961711|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|0.81|STANDARD_ERROR_OF_MEAN|0.52||0.941|TWO_SIDED|90.0|-0.04|1.67|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.67|-0.04|0.941
70961712|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|0.96|STANDARD_ERROR_OF_MEAN|0.63||0.936|TWO_SIDED|90.0|-0.08|2.01|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.01|-0.08|0.936
70961713|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|1.17|STANDARD_ERROR_OF_MEAN|0.64||0.965|TWO_SIDED|90.0|0.11|2.23|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.23|0.11|0.965
70961714|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.56||0.855|TWO_SIDED|90.0|-0.33|1.51|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.51|-0.33|0.855
70961715|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|0.42|STANDARD_ERROR_OF_MEAN|0.58||0.765|TWO_SIDED|90.0|-0.54|1.38|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.38|-0.54|0.765
70961716|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.51||0.504|TWO_SIDED|90.0|-0.84|0.85|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.85|-0.84|0.504
70961717|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.52||0.643|TWO_SIDED|90.0|-0.67|1.06|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.06|-0.67|0.643
70961718|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.64||0.486|TWO_SIDED|90.0|-1.09|1.04|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.04|-1.09|0.486
70961719|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.65||0.6|TWO_SIDED|90.0|-0.91|1.24|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.24|-0.91|0.600
70961720|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.57||0.418|TWO_SIDED|90.0|-1.05|0.82|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.82|-1.05|0.418
70961721|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.59||0.515|TWO_SIDED|90.0|-0.95|0.99|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.99|-0.95|0.515
70961722|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.53||0.456|TWO_SIDED|90.0|-0.93|0.81|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.81|-0.93|0.456
70961723|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.54||0.556|TWO_SIDED|90.0|-0.82|0.97|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.97|-0.82|0.556
70961724|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.67||0.448|TWO_SIDED|90.0|-1.19|1.02|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.02|-1.19|0.448
70961725|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.68||0.6|TWO_SIDED|90.0|-0.95|1.3|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.30|-0.95|0.600
70961726|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.59||0.225|TWO_SIDED|90.0|-1.41|0.52|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.52|-1.41|0.225
70961727|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.61||0.387|TWO_SIDED|90.0|-1.18|0.83|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.83|-1.18|0.387
70961728|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.54||0.657|TWO_SIDED|90.0|-0.67|1.11|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.11|-0.67|0.657
70961729|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.55||0.808|TWO_SIDED|90.0|-0.43|1.4|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.40|-0.43|0.808
70961730|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|0.45|STANDARD_ERROR_OF_MEAN|0.68||0.742|TWO_SIDED|90.0|-0.68|1.57|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.57|-0.68|0.742
70961731|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|0.99|STANDARD_ERROR_OF_MEAN|0.7||0.923|TWO_SIDED|90.0|-0.16|2.14|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.14|-0.16|0.923
70961732|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.6||0.49|TWO_SIDED|90.0|-1.01|0.98|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.98|-1.01|0.490
70961733|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.62||0.609|TWO_SIDED|90.0|-0.86|1.2|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.20|-0.86|0.609
70961734|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.55||0.362|TWO_SIDED|90.0|-1.1|0.71|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.71|-1.10|0.362
70881203|NCT02515942|141247219|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.25||||0.053|TWO_SIDED|80.0|-0.45|-0.05|||Mixed Models Analysis|||Change from baseline at Day 253||-0.05|-0.45|0.0530
70961735|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.56||0.61|TWO_SIDED|90.0|-0.77|1.09|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.09|-0.77|0.610
70961736|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.7||0.376|TWO_SIDED|90.0|-1.37|0.93|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.93|-1.37|0.376
70961737|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.71||0.733|TWO_SIDED|90.0|-0.73|1.6|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.60|-0.73|0.733
70961738|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.61||0.303|TWO_SIDED|90.0|-1.33|0.69|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.69|-1.33|0.303
70961739|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.63||0.548|TWO_SIDED|90.0|-0.97|1.12|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.12|-0.97|0.548
70961740|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.56||0.609|TWO_SIDED|90.0|-0.77|1.08|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.08|-0.77|0.609
70961741|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.59||0.59|TWO_SIDED|90.0|-0.83|1.1|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.10|-0.83|0.590
70961742|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.71||0.556|TWO_SIDED|90.0|-1.07|1.27|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.27|-1.07|0.556
70961743|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.73||0.443|TWO_SIDED|90.0|-1.32|1.11|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.11|-1.32|0.443
70961744|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.62||0.527|TWO_SIDED|90.0|-0.99|1.07|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.07|-0.99|0.527
70961745|NCT00568321|141428455|SUPERIORITY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.66||0.583|TWO_SIDED|90.0|-0.95|1.22|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.22|-0.95|0.583
70961746|NCT00568321|141428458|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.63||0.111|TWO_SIDED|90.0|-1.81|0.27|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.27|-1.81|0.111
70961747|NCT00568321|141428458|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.64||0.523|TWO_SIDED|90.0|-1.02|1.09|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.09|-1.02|0.523
70961748|NCT00568321|141428458|SUPERIORITY||LS Mean Difference|0.77|STANDARD_ERROR_OF_MEAN|0.63||0.887|TWO_SIDED|90.0|-0.28|1.81|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.81|-0.28|0.887
70961749|NCT00568321|141428458|SUPERIORITY||LS Mean Difference|0.85|STANDARD_ERROR_OF_MEAN|0.65||0.903|TWO_SIDED|90.0|-0.23|1.92|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.92|-0.23|0.903
70961750|NCT00568321|141428458|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.64||0.472|TWO_SIDED|90.0|-1.11|1.02|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.02|-1.11|0.472
70881204|NCT02515942|141247219|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.17||||0.1386|TWO_SIDED|80.0|-0.37|0.03|||Mixed Models Analysis|||Change from baseline at Day 253||0.03|-0.37|0.1386
70961751|NCT00568321|141428458|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.66||0.628|TWO_SIDED|90.0|-0.87|1.3|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.30|-0.87|0.628
70961752|NCT00568321|141428458|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.67||0.243|TWO_SIDED|90.0|-1.58|0.64|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.64|-1.58|0.243
70961753|NCT00568321|141428458|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.69||0.346|TWO_SIDED|90.0|-1.42|0.87|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.87|-1.42|0.346
70961754|NCT00568321|141428458|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.69||0.467|TWO_SIDED|90.0|-1.19|1.08|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.08|-1.19|0.467
70961755|NCT00568321|141428458|SUPERIORITY||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.7||0.67|TWO_SIDED|90.0|-0.85|1.47|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.47|-0.85|0.670
70961756|NCT00568321|141428458|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.7||0.286|TWO_SIDED|90.0|-1.55|0.76|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.76|-1.55|0.286
70961757|NCT00568321|141428458|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.71||0.598|TWO_SIDED|90.0|-1.0|1.35|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.35|-1.00|0.598
70961758|NCT00568321|141428458|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.71||0.453|TWO_SIDED|90.0|-1.26|1.09|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.09|-1.26|0.453
70961759|NCT00568321|141428458|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.74||0.472|TWO_SIDED|90.0|-1.28|1.17|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.17|-1.28|0.472
70961760|NCT00568321|141428472|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|1.02||0.548|TWO_SIDED|90.0|-1.81|1.56|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.56|-1.81|0.548
70961761|NCT00568321|141428472|SUPERIORITY||LS Mean Difference|1.24|STANDARD_ERROR_OF_MEAN|1.04||0.117|TWO_SIDED|90.0|-0.48|2.96|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.96|-0.48|0.117
70961762|NCT00568321|141428472|SUPERIORITY||LS Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|1.11||0.779|TWO_SIDED|90.0|-2.69|0.98|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.98|-2.69|0.779
70961763|NCT00568321|141428472|SUPERIORITY||LS Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|1.14||0.375|TWO_SIDED|90.0|-1.52|2.25|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.25|-1.52|0.375
70961764|NCT00568321|141428472|SUPERIORITY||LS Mean Difference|-1.36|STANDARD_ERROR_OF_MEAN|1.15||0.881|TWO_SIDED|90.0|-3.26|0.54|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.54|-3.26|0.881
70961765|NCT00568321|141428472|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|1.17||0.636|TWO_SIDED|90.0|-2.33|1.52|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.52|-2.33|0.636
70961766|NCT00568321|141428472|SUPERIORITY||LS Mean Difference|-1.54|STANDARD_ERROR_OF_MEAN|1.17||0.905|TWO_SIDED|90.0|-3.46|0.39|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.39|-3.46|0.905
70881205|NCT02515942|141247219|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.08||||0.7087|TWO_SIDED|80.0|-0.11|0.27|||Mixed Models Analysis|||Change from baseline at Day 253||0.27|-0.11|0.7087
70961767|NCT00568321|141428472|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.21||0.499|TWO_SIDED|90.0|-2.0|2.0|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.00|-2.00|0.499
70961768|NCT00568321|141428472|SUPERIORITY||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.5||0.297|TWO_SIDED|90.0|-0.56|1.09|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.09|-0.56|0.297
70961769|NCT00568321|141428472|SUPERIORITY||LS Mean Difference|0.91|STANDARD_ERROR_OF_MEAN|0.5||0.035|TWO_SIDED|90.0|0.09|1.74|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.74|0.09|0.035
70961770|NCT00568321|141428472|SUPERIORITY||LS Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.54||0.222|TWO_SIDED|90.0|-0.48|1.31|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.31|-0.48|0.222
70961771|NCT00568321|141428472|SUPERIORITY||LS Mean Difference|0.81|STANDARD_ERROR_OF_MEAN|0.54||0.069|TWO_SIDED|90.0|-0.09|1.7|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.70|-0.09|0.069
70961772|NCT00568321|141428472|SUPERIORITY||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.55||0.338|TWO_SIDED|90.0|-0.68|1.15|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.15|-0.68|0.338
70881206|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.72||||0.9243|TWO_SIDED|80.0|-5.15|-0.29|||Mixed Models Analysis|||Change from baseline at Day 2||-0.29|-5.15|0.9243
70881207|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.51||||0.3929|TWO_SIDED|80.0|-1.89|2.91|||Mixed Models Analysis|||Change from baseline at Day 2||2.91|-1.89|0.3929
70881208|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.23||||0.0418|TWO_SIDED|80.0|0.85|5.61|||Mixed Models Analysis|||Change from baseline at Day 2||5.61|0.85|0.0418
70881209|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.32||||0.5632|TWO_SIDED|80.0|-2.91|2.27|||Mixed Models Analysis|||Change from baseline at Day 8||2.27|-2.91|0.5632
70881210|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.29||||0.2575|TWO_SIDED|80.0|-1.25|3.83|||Mixed Models Analysis|||Change from baseline at Day 8||3.83|-1.25|0.2575
70881211|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.61||||0.2058|TWO_SIDED|80.0|-0.91|4.12|||Mixed Models Analysis|||Change from baseline at Day 8||4.12|-0.91|0.2058
70881212|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.94||||0.8392|TWO_SIDED|80.0|-4.44|0.57|||Mixed Models Analysis|||Change from baseline at Day 15||0.57|-4.44|0.8392
70881213|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effecgt|-0.12||||0.5255|TWO_SIDED|80.0|-2.59|2.35|||Mixed Models Analysis|||Change from baseline at Day 15||2.35|-2.59|0.5255
70881214|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.81||||0.1685|TWO_SIDED|80.0|-0.61|4.24|||Mixed Models Analysis|||Change from baseline at Day 15||4.24|-0.61|0.1685
70881215|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment|-2.01||||0.8544|TWO_SIDED|80.0|-4.45|0.43|||Mixed Models Analysis|||Change from baseline at Day 29||0.43|-4.45|0.8544
70881216|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.03||||0.1402|TWO_SIDED|80.0|-0.38|4.44|||Mixed Models Analysis|||Change from baseline at Day 29||4.44|-0.38|0.1402
70881217|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|4.03||||0.015|TWO_SIDED|80.0|1.67|6.4|||Mixed Models Analysis|||Change from baseline at Day 29||6.40|1.67|0.0150
70881218|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.14||||0.4682|TWO_SIDED|80.0|-2.11|2.39|||Mixed Models Analysis|||Change from baseline at Day 30||2.39|-2.11|0.4682
70881219|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.38||||0.4125|TWO_SIDED|80.0|-1.84|2.6|||Mixed Models Analysis|||Change from baseline at Day 30||2.60|-1.84|0.4125
70881220|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.24||||0.4431|TWO_SIDED|80.0|-1.94|2.42|||Mixed Models Analysis|||Change from baseline at Day 30||2.42|-1.94|0.4431
70881221|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.04||||0.6924|TWO_SIDED|80.0|-3.72|1.63|||Mixed Models Analysis|||Change from baseline at Day 57||1.63|-3.72|0.6924
70881222|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.61||||0.616|TWO_SIDED|80.0|-3.26|2.04|||Mixed Models Analysis|||Change from baseline at Day 57||2.04|-3.26|0.6160
70881223|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.44||||0.4149|TWO_SIDED|80.0|-2.18|3.06|||Mixed Models Analysis|||Change from baseline at Day 57||3.06|-2.18|0.4149
70881224|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.29||||0.2582|TWO_SIDED|80.0|-1.27|3.85|||Mixed Models Analysis|||Change from baseline at Day 85||3.85|-1.27|0.2582
70881225|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.81||||0.3402|TWO_SIDED|80.0|-1.72|3.34|||Mixed Models Analysis|||Change from baseline at Day 85||3.34|-1.72|0.3402
70881226|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.48||||0.5976|TWO_SIDED|80.0|-2.99|2.03|||Mixed Models Analysis|||Change from baseline at Day 85||2.03|-2.99|0.5976
70881227|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.5||||0.5916|TWO_SIDED|80.0|-3.3|2.29|||Mixed Models Analysis|||Change from baseline at Day 113||2.29|-3.30|0.5916
70961773|NCT00568321|141428472|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.56||0.381|TWO_SIDED|90.0|-0.75|1.09|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.09|-0.75|0.381
70881228|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.3||||0.5564|TWO_SIDED|80.0|-3.05|2.45|||Mixed Models Analysis|||Change from baseline at Day 113||2.45|-3.05|0.5564
70881229|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.2||||0.4625|TWO_SIDED|80.0|-2.53|2.93|||Mixed Models Analysis|||Change from baseline at Day 113||2.93|-2.53|0.4625
70881230|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.94||||0.8221|TWO_SIDED|80.0|-4.64|0.76|||Mixed Models Analysis|||Change from baseline at Day 141||0.76|-4.64|0.8221
70881231|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.98||||0.3179|TWO_SIDED|80.0|-1.68|3.64|||Mixed Models Analysis|||Change from baseline at Day 141||3.64|-1.68|0.3179
70881232|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.92||||0.0773|TWO_SIDED|80.0|0.29|5.55|||Mixed Models Analysis|||Change from baseline at Day 141||5.55|0.29|0.0773
70881233|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.95||||0.6708|TWO_SIDED|80.0|-3.71|1.81|||Mixed Models Analysis|||Change from baseline at Day 169||1.81|-3.71|0.6708
70881234|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.99||||0.679|TWO_SIDED|80.0|-3.71|1.74|||Mixed Models Analysis|||Change from baseline at Day 169||1.74|-3.71|0.6790
70881235|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.04||||0.507|TWO_SIDED|80.0|-2.72|2.64|||Mixed Models Analysis|||Change from baseline at Day 169||2.64|-2.72|0.5070
70881236|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.3||||0.5487|TWO_SIDED|80.0|-3.44|2.84|||Mixed Models Analysis|||Change from baseline at Day 197||2.84|-3.44|0.5487
70881237|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.25||||0.6973|TWO_SIDED|80.0|-4.35|1.85|||Mixed Models Analysis|||Change from baseline at Day 197||1.85|-4.35|0.6973
70881238|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.95||||0.6548|TWO_SIDED|80.0|-4.0|2.11|||Mixed Models Analysis|||Change from baseline at Day 197||2.11|-4.00|0.6548
70961774|NCT00568321|141428472|SUPERIORITY||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.56||0.306|TWO_SIDED|90.0|-0.64|1.21|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.21|-0.64|0.306
70961775|NCT00568321|141428472|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.58||0.44|TWO_SIDED|90.0|-0.87|1.04|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.04|-0.87|0.440
70961776|NCT01676909|141428480|SUPERIORITY|||||||0.362|||||||Mixed Models Analysis|||To test hypothesis 1, regarding the three SF-12 subscales, a linear mixed effects models was used. All available data were used from all three assessment time points. Group, time, and group-by-time terms were included in the model. To test for a group difference in mean change from baseline to post-intervention, the significance test of the group-by-post-intervention coefficient was performed. A logistic mixed model for change in proportion with an ED visit was used to test hypothesis 2.||||0.362
70961777|NCT01676909|141428481|SUPERIORITY|||||||0.026|||||||Mixed Models Analysis|||To test hypothesis 1, regarding the three SF-12 subscales, a linear mixed effects models was used. All available data were used from all three assessment time points. Group, time, and group-by-time terms were included in the model. To test for a group difference in mean change from baseline to post-intervention, the significance test of the group-by-post-intervention coefficient was performed. A logistic mixed model for change in proportion with an ED visit was used to test hypothesis 2.||||0.026
70961778|NCT01676909|141428482|SUPERIORITY|||||||0.032|||||||Mixed Models Analysis|||To test hypothesis 1, regarding the three SF-12 subscales, a linear mixed effects models was used. All available data were used from all three assessment time points. Group, time, and group-by-time terms were included in the model. To test for a group difference in mean change from baseline to post-intervention, the significance test of the group-by-post-intervention coefficient was performed. A logistic mixed model for change in proportion with an ED visit was used to test hypothesis 2.||||0.032
70961779|NCT01676909|141428483|SUPERIORITY|||||||0.64|||||||Mixed Models Analysis|||A logistic mixed effects model over two 6-month time periods (prior to baseline and between baseline and the 6-month follow-up visit) was used. Terms in the model included group, binary time (pre-f/u versus pre-baseline), and group by time interaction. Two-sided alpha = .05 level tests were used. The hypothesis that the proportion with ER visits would decrease in the Living Well group versus the control group was tests by test of the interaction term.||||.64
70961780|NCT01676909|141428484|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||<.0001
70881239|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.35||||0.5533|TWO_SIDED|80.0|-3.76|3.05|||Mixed Models Analysis|||Change from baseline at Day 225||3.05|-3.76|0.5533
70961781|NCT01676909|141428485|SUPERIORITY|||||||0.038|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.038
70961782|NCT01676909|141428486|SUPERIORITY|||||||0.544|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.544
70961783|NCT01676909|141428487|SUPERIORITY|||||||0.699|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.699
70961784|NCT01676909|141428488|SUPERIORITY|||||||0.006|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.006
70961785|NCT01676909|141428489|SUPERIORITY|||||||0.762|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.762
70961786|NCT01676909|141428490|SUPERIORITY|||||||0.326|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.326
70961787|NCT01676909|141428491|SUPERIORITY|||||||0.667|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.667
70961788|NCT01676909|141428492|SUPERIORITY|||||||0.142|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.142
70961789|NCT01676909|141428493|SUPERIORITY|||||||0.342|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.342
70961790|NCT01676909|141428494|SUPERIORITY|||||||0.563|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.563
70881240|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.11||||0.3358|TWO_SIDED|80.0|-2.25|4.46|||Mixed Models Analysis|||Change from baseline at Day 225||4.46|-2.25|0.3358
70961791|NCT01676909|141428495|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.004
70961792|NCT01676909|141428496|SUPERIORITY|||||||0.727|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.727
70881241|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.46||||0.285|TWO_SIDED|80.0|-1.85|4.77|||Mixed Models Analysis|||Change from baseline at Day 225||4.77|-1.85|0.2850
70961793|NCT01676909|141428497|SUPERIORITY|||||||0.446|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.446
70881242|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.55||||0.5778|TWO_SIDED|80.0|-4.14|3.04|||Mixed Models Analysis|||Change from baseline at Day 253||3.04|-4.14|0.5778
70961794|NCT01676909|141428498|SUPERIORITY|||||||0.459|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.459
70881243|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.3||||0.2018|TWO_SIDED|80.0|-1.24|5.85|||Mixed Models Analysis|||Change from baseline at Day 253||5.85|-1.24|0.2018
70961795|NCT01676909|141428499|SUPERIORITY|||||||0.038|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.038
70961796|NCT01676909|141428500|SUPERIORITY|||||||0.238|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.238
70961797|NCT01676909|141428501|SUPERIORITY|||||||0.011|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.011
70961798|NCT01676909|141428502|SUPERIORITY|||||||0.709|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.709
70961799|NCT01676909|141428503|SUPERIORITY|||||||0.134|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.134
70961800|NCT01676909|141428504|SUPERIORITY|||||||0.045|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.045
70961801|NCT01676909|141428505|SUPERIORITY|||||||0.099|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.099
70961802|NCT01676909|141428506|SUPERIORITY|||||||0.852|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.852
70961803|NCT01676909|141428507|SUPERIORITY|||||||0.285|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.285
70961804|NCT01676909|141428508|SUPERIORITY|||||||0.222|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.222
70961805|NCT00221195|141428524|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||The Wilcoxin signed-rank test was used to compare the frequency of bleeds between the prophylaxis and on-demand periods.||||<0.001
70961806|NCT03548987|141428555|SUPERIORITY||Treatment difference|-14.75|||<|0.0001|TWO_SIDED|95.0|-16.0|-13.5|||ANCOVA|||Treatment policy estimand||-13.50|-16.00|<0.0001
70961807|NCT03548987|141428555|OTHER||Treatment difference|-15.33|||<|0.0001|TWO_SIDED|95.0|-16.52|-14.13|||MMRM (mixed model repeated measurement)|||Hypothetical estimand||-14.13|-16.52|<0.0001
70961808|NCT01106014|141428595|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||<|0.0001|TWO_SIDED|99.0|0.46|0.78||one-sided p-value|Log Rank|||The primary analysis was performed on the Full Analysis Set by a one-sided unstratified log-rank test||0.78|0.46|<0.0001
70961809|NCT01106014|141428596|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|12.0||||0.0027|TWO_SIDED|99.0|1.0|24.0||One-sided p-value of the nonparametric ANCOVA, adjusted for 6-minute walk distance at baseline|ANCOVA||Point estimate and 2-sided 99% CI for location shift using the HodgesLehmann method|Non-parametric ANCOVA with 6MWD as covariate at baseline. Missing values were imputed based on the following imputation rules: 1) if patient was unable to walk at week 26, 0 meter was imputed, 2) if rule 1 did not apply, the second lowest observed 6MWD value (10 meters) at Week 26 was imputed. Missing values were imputed for 21.6% of the subjects.||24|1|0.0027
70961810|NCT01106014|141428597|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|It was assumed that the probabilities for absence of worsening in WHO FC at Week 26 were the same for both treatment groups|Odds Ratio, log|1.161||||0.2843|TWO_SIDED|99.0|0.811|1.664||Cochran-Mantel-Haenszel test stratified by WHO FC at baseline. For patients with missing NYHA/WHO FC at Week 26, the NYHA/WHO FC is considered as having worsened from baseline at Week 26. Missing values were imputed for 18.3% of subjects .|Cochran-Mantel-Haenszel|||||1.664|0.811|0.2843
70961811|NCT00784693|141428598|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|90.0|-0.87|1.69||||||Week 8: Analysis was based on analysis of co-variance (ANCOVA) model with main effects of treatment, contraceptive use and baseline severity of pain.||1.69|-0.87|
70961812|NCT02260882|141428631|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Serotype 3. The statistical success criterion for demonstrating greater geometric mean antibody concentrations at 4 weeks postvaccination is that the lower bound of the 2-sided 95% confidence interval in Geometric Mean Fold Rise will be greater than 1 for all 3 serotypes.||||<0.001
70961813|NCT02260882|141428631|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Serotype 6B. The statistical success criterion for demonstrating greater geometric mean antibody concentrations at 4 weeks postvaccination is that the lower bound of the 2-sided 95% confidence interval in Geometric Mean Fold Rise will be greater than 1 for all 3 serotypes.||||<0.001
70961814|NCT02260882|141428631|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Serotype 23F. The statistical success criterion for demonstrating greater geometric mean antibody concentrations at 4 weeks postvaccination is that the lower bound of the 2-sided 95% confidence interval in Geometric Mean Fold Rise will be greater than 1 for all 3 serotypes.||||<0.001
70961815|NCT02119325|141428641|SUPERIORITY_OR_OTHER||Difference in Adjusted Mean|-4.64||||0.0487|TWO_SIDED|95.0|-9.26|-0.03||Statistical significance at the 5% level was required for both co-primary endpoints in order to progress to formal assessment of secondary endpoints.|ANOVA||Difference is test minus placebo such that a positive difference means the test has higher Cmax|"H0: There was no difference in the post prandial glucose peak for participants with IFG between the test and placebo.~The primary parameter was analysed using a mixed effects model with glucose as dependent variable, treatment and period as fixed effects and subject as random effect."||-0.03|-9.26|0.0487
70961816|NCT02119325|141428642|SUPERIORITY_OR_OTHER||Difference in Adjusted Mean|-6.79||||0.6116|TWO_SIDED|95.0|-34.02|20.44||Statistical significance at the 5% level was required for both co-primary endpoints in order to progress to formal assessment of secondary endpoints.|ANOVA||Difference is test minus placebo such that a positive difference means the test has higher Cmax|"H0: There was no difference in the post prandial triglyceride peak for participants with IFG between the test and placebo.~The primary parameter was analysed using a mixed effects model with triglyceride as dependent variable, treatment and period as fixed effects and subject as random effect."||20.44|-34.02|0.6116
70961817|NCT01794923|141428698|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2|TWO_SIDED||||||ANOVA|||Analysis was performed using an analysis of variance (ANOVA) model with treatment, baseline categorical pain severity rating (PSR), sex, and baseline muscle soreness with movement (MSM) terms.||||0.200
70961818|NCT01794923|141428698|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|7.6||||0.23|TWO_SIDED|95.0|-4.81|19.92|||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical pain severity rating (PSR), sex, and baseline muscle soreness with movement (MSM) terms.||19.92|-4.81|0.230
70961819|NCT01794923|141428698|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.4||||0.484|TWO_SIDED|95.0|-16.81|7.99|||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical pain severity rating (PSR), sex, and baseline muscle soreness with movement (MSM) terms.||7.99|-16.81|0.484
70961820|NCT01794923|141428698|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|12.0||||0.077|TWO_SIDED|95.0|-1.32|25.25|||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical pain severity rating (PSR), sex, and baseline muscle soreness with movement (MSM) terms.||25.25|-1.32|0.077
70961821|NCT01794923|141428699|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86|TWO_SIDED||||||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.860
70961822|NCT01794923|141428699|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|7.0||||0.584|TWO_SIDED|95.0|-18.3|32.38|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||32.38|-18.30|0.584
70961823|NCT01794923|141428699|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.6||||0.838|TWO_SIDED|95.0|-22.77|28.06|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||28.06|-22.77|0.838
70961824|NCT01794923|141428699|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.4||||0.75|TWO_SIDED|95.0|-22.81|31.61|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||31.61|-22.81|0.750
70961825|NCT01794923|141428699|SUPERIORITY_OR_OTHER_LEGACY|||||||0.533|TWO_SIDED||||||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.533
70961826|NCT01794923|141428699|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-13.9||||0.326|TWO_SIDED|95.0|-41.81|13.95|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||13.95|-41.81|0.326
70961827|NCT01794923|141428699|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.0||||0.945|TWO_SIDED|95.0|-26.98|28.94|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||28.94|-26.98|0.945
70961828|NCT01794923|141428699|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-14.9||||0.327|TWO_SIDED|95.0|-44.85|15.03|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||15.03|-44.85|0.327
70961829|NCT01794923|141428699|SUPERIORITY_OR_OTHER_LEGACY|||||||0.988|TWO_SIDED||||||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.988
70961830|NCT01794923|141428699|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.2||||0.887|TWO_SIDED|95.0|-48.31|41.81|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||41.81|-48.31|0.887
70961831|NCT01794923|141428699|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.7||||0.907|TWO_SIDED|95.0|-47.88|42.5|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||42.50|-47.88|0.907
70961832|NCT01794923|141428699|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.982|TWO_SIDED|95.0|-48.95|47.83|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||47.83|-48.95|0.982
70961833|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63|TWO_SIDED||||||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.630
70961834|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.342|TWO_SIDED|95.0|-0.39|0.14|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.14|-0.39|0.342
70961835|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.6|TWO_SIDED|95.0|-0.34|0.19|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.19|-0.34|0.600
70961836|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.691|TWO_SIDED|95.0|-0.34|0.23|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.23|-0.34|0.691
70961837|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.091|TWO_SIDED||||||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.091
70961838|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.351|TWO_SIDED|95.0|-0.44|0.16|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.16|-0.44|0.351
70961839|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.029|TWO_SIDED|95.0|-0.64|-0.04|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||-0.04|-0.64|0.029
70961840|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.238|TWO_SIDED|95.0|-0.13|0.52|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.52|-0.13|0.238
70961841|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.305|TWO_SIDED||||||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.305
70961842|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.37|TWO_SIDED|95.0|-0.54|0.2|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.20|-0.54|0.370
70961843|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.13|TWO_SIDED|95.0|-0.66|0.09|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.09|-0.66|0.130
70961844|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.561|TWO_SIDED|95.0|-0.28|0.51|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.51|-0.28|0.561
70961845|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.209|TWO_SIDED||||||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.209
70961846|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.277|TWO_SIDED|95.0|-0.68|0.19|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.19|-0.68|0.277
70961847|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.085|TWO_SIDED|95.0|-0.82|0.05|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.05|-0.82|0.085
70961848|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.546|TWO_SIDED|95.0|-0.32|0.61|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.61|-0.32|0.546
70961849|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.185|TWO_SIDED||||||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.185
70961850|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.4|TWO_SIDED|95.0|-0.64|0.26|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.26|-0.64|0.400
70961851|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.067|TWO_SIDED|95.0|-0.88|0.03|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.03|-0.88|0.067
70961852|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.35|TWO_SIDED|95.0|-0.25|0.71|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.71|-0.25|0.350
70961853|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.493|TWO_SIDED||||||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.493
70961854|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.922|TWO_SIDED|95.0|-0.53|0.48|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.48|-0.53|0.922
70961855|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.265|TWO_SIDED|95.0|-0.8|0.22|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.22|-0.80|0.265
70961856|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.342|TWO_SIDED|95.0|-0.28|0.81|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.81|-0.28|0.342
70881244|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.85||||0.1457|TWO_SIDED|80.0|-0.62|6.32|||Mixed Models Analysis|||Change from baseline at Day 253||6.32|-0.62|0.1457
70881245|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.56||||0.5758|TWO_SIDED|80.0|-4.29|3.18|||Mixed Models Analysis|||Change from baseline at Day 281||3.18|-4.29|0.5758
70881246|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.85||||0.3833|TWO_SIDED|80.0|-2.84|4.55|||Mixed Models Analysis|||Change from baseline at Day 281||4.55|-2.84|0.3833
70881247|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.41||||0.3083|TWO_SIDED|80.0|-2.21|5.02|||Mixed Models Analysis|||Change from baseline at Day 281||5.02|-2.21|0.3083
70881248|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.54||||0.7063|TWO_SIDED|80.0|-5.19|2.11|||Mixed Models Analysis|||Change from baseline at Day 309||2.11|-5.19|0.7063
70881249|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.14||||0.2227|TWO_SIDED|80.0|-1.46|5.74|||Mixed Models Analysis|||Change from baseline at Day 309||5.74|-1.46|0.2227
70881250|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.68||||0.0907|TWO_SIDED|80.0|0.15|7.21|||Mixed Models Analysis|||Change from baseline at Day 309||7.21|0.15|0.0907
70881251|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.17||||0.4799|TWO_SIDED|80.0|-4.23|4.57|||Mixed Models Analysis|||Change from baseline at Day 337||4.57|-4.23|0.4799
70881252|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.2||||0.5237|TWO_SIDED|80.0|-4.54|4.14|||Mixed Models Analysis|||Change from baseline at Day 337||4.14|-4.54|0.5237
70881253|NCT02515942|141247221|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.37||||0.5451|TWO_SIDED|80.0|-4.62|3.87|||Mixed Models Analysis|||Change from baseline at Day 337||3.87|-4.62|0.5451
70881254|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.15||||0.4609|TWO_SIDED|80.0|-1.79|2.09|||Mixed Models Analysis|||Change from baseline at Day 2||2.09|-1.79|0.4609
70881255|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.46||||0.3771|TWO_SIDED|80.0|-1.44|2.37|||Mixed Models Analysis|||Change from baseline at Day 2||2.37|-1.44|0.3771
70881256|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.32||||0.4161|TWO_SIDED|80.0|-1.6|2.24|||Mixed Models Analysis|||Change from baseline at Day 2||2.24|-1.60|0.4161
70881257|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.88||||0.9385|TWO_SIDED|80.0|-5.26|-0.49|||Mixed Models Analysis|||Change from baseline at Day 29||-0.49|-5.26|0.9385
70881258|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.4||||0.5862|TWO_SIDED|80.0|-2.76|1.96|||Mixed Models Analysis|||Change from baseline at Day 29||1.96|-2.76|0.5862
70961857|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.311|TWO_SIDED||||||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.311
70881259|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.48||||0.0875|TWO_SIDED|80.0|0.14|4.82|||Mixed Models Analysis|||Change from baseline at Day 29||4.82|0.14|0.0875
70961858|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.865|TWO_SIDED|95.0|-0.49|0.58|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.58|-0.49|0.865
70881260|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.53||||0.4059|TWO_SIDED|80.0|-2.32|3.37|||Mixed Models Analysis|||Change from baseline at Day 57||3.37|-2.32|0.4059
70881261|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.24||||0.286|TWO_SIDED|80.0|-1.58|4.05|||Mixed Models Analysis|||Change from baseline at Day 57||4.05|-1.58|0.2860
70961859|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.193|TWO_SIDED|95.0|-0.89|0.18|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.18|-0.89|0.193
70961860|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.17|TWO_SIDED|95.0|-0.17|0.97|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.97|-0.17|0.170
70961861|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.383|TWO_SIDED||||||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.383
70881262|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.71||||0.3727|TWO_SIDED|80.0|-2.1|3.52|||Mixed Models Analysis|||Change from baseline at Day 57||3.52|-2.10|0.3727
70961862|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.802|TWO_SIDED|95.0|-0.48|0.62|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.62|-0.48|0.802
70881263|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.91||||0.336|TWO_SIDED|80.0|-1.85|3.66|||Mixed Models Analysis|||Change from baseline at Day 85||3.66|-1.85|0.3360
70961863|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.26|TWO_SIDED|95.0|-0.87|0.24|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.24|-0.87|0.260
70961864|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.199|TWO_SIDED|95.0|-0.21|0.98|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.98|-0.21|0.199
70881264|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.95||||0.0316|TWO_SIDED|80.0|1.24|6.66|||Mixed Models Analysis|||Change from baseline at Day 85||6.66|1.24|0.0316
70961865|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.139|TWO_SIDED||||||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.139
70961866|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.441|TWO_SIDED|95.0|-0.35|0.8|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.80|-0.35|0.441
70961867|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.183|TWO_SIDED|95.0|-0.96|0.18|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.18|-0.96|0.183
70961868|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.6||||0.05|TWO_SIDED|95.0|0.0|1.23|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.23|-0.00|0.050
70961869|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.221|TWO_SIDED||||||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.221
70961870|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.526|TWO_SIDED|95.0|-0.4|0.79|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.79|-0.40|0.526
70961871|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-0.4||||0.232|TWO_SIDED|95.0|-0.96|0.23|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.23|-0.96|0.232
70961872|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.6||||0.089|TWO_SIDED|95.0|-0.08|1.19|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.19|-0.08|0.089
70961873|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19|TWO_SIDED||||||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.190
70961874|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.365|TWO_SIDED|95.0|-0.31|0.85|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.85|-0.31|0.365
70961875|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.295|TWO_SIDED|95.0|-0.89|0.27|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.27|-0.89|0.295
70961876|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.6||||0.069|TWO_SIDED|95.0|-0.05|1.2|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.20|-0.05|0.069
70961877|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.197|TWO_SIDED||||||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.197
70961878|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.309|TWO_SIDED|95.0|-0.29|0.92|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.92|-0.29|0.309
70961879|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.359|TWO_SIDED|95.0|-0.89|0.33|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.33|-0.89|0.359
70961880|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.6||||0.072|TWO_SIDED|95.0|-0.05|1.25|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.25|-0.05|0.072
70961881|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.151|TWO_SIDED||||||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.151
70961882|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.6||||0.09|TWO_SIDED|95.0|-0.1|1.32|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.32|-0.10|0.090
70961883|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.889|TWO_SIDED|95.0|-0.76|0.66|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.66|-0.76|0.889
70961884|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.7||||0.088|TWO_SIDED|95.0|-0.1|1.42|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.42|-0.10|0.088
70961885|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.673|TWO_SIDED||||||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.673
70961886|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.393|TWO_SIDED|95.0|-0.41|1.04|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.04|-0.41|0.393
70961887|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.887|TWO_SIDED|95.0|-0.67|0.78|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.78|-0.67|0.887
70881265|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.04||||0.0762|TWO_SIDED|80.0|0.32|5.76|||Mixed Models Analysis|||Change from baseline at Day 85||5.76|0.32|0.0762
70961888|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.507|TWO_SIDED|95.0|-0.51|1.04|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.04|-0.51|0.507
70961889|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.873|TWO_SIDED||||||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.873
70961890|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.605|TWO_SIDED|95.0|-0.58|1.0|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.00|-0.58|0.605
70961891|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.86|TWO_SIDED|95.0|-0.72|0.86|||ANOVA|||26 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.86|-0.72|0.860
70961892|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.751|TWO_SIDED|95.0|-0.71|0.98|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.98|-0.71|0.751
70961893|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.528|TWO_SIDED||||||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.528
70961894|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.486|TWO_SIDED|95.0|-1.09|0.52|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.52|-1.09|0.486
70961895|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.61|TWO_SIDED|95.0|-0.6|1.02|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.02|-0.60|0.610
70881266|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.68||||0.0544|TWO_SIDED|80.0|0.75|6.61|||Mixed Models Analysis|||Change from baseline at Day 113||6.61|0.75|0.0544
70961896|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5||||0.261|TWO_SIDED|95.0|-1.36|0.37|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.37|-1.36|0.261
70961897|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.943|TWO_SIDED||||||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.943
70961898|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.733|TWO_SIDED|95.0|-0.96|0.68|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.68|-0.96|0.733
70961899|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.902|TWO_SIDED|95.0|-0.87|0.77|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.77|-0.87|0.902
70961900|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.84|TWO_SIDED|95.0|-0.97|0.79|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.79|-0.97|0.840
70961901|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.758|TWO_SIDED||||||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.758
70961902|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.493|TWO_SIDED|95.0|-1.12|0.54|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.54|-1.12|0.493
70961903|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.974|TWO_SIDED|95.0|-0.84|0.82|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.82|-0.84|0.974
70961904|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.543|TWO_SIDED|95.0|-1.16|0.61|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.61|-1.16|0.543
70961905|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.238|TWO_SIDED||||||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.238
70961906|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7||||0.106|TWO_SIDED|95.0|-1.46|0.14|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.14|-1.46|0.106
70961907|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.817|TWO_SIDED|95.0|-0.9|0.71|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.71|-0.90|0.817
70961908|NCT01794923|141428700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.197|TWO_SIDED|95.0|-1.43|0.3|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.30|-1.43|0.197
70961909|NCT01794923|141428701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.702|TWO_SIDED||||||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||||0.702
70961910|NCT01794923|141428701|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.8||||0.664|TWO_SIDED|95.0|-9.91|15.53|||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||15.53|-9.91|0.664
70961911|NCT01794923|141428701|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.0||||0.637|TWO_SIDED|95.0|-15.77|9.68|||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||9.68|-15.77|0.637
70961912|NCT01794923|141428701|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.9||||0.401|TWO_SIDED|95.0|-7.85|19.57|||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||19.57|-7.85|0.401
70961913|NCT01794923|141428701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.926|TWO_SIDED||||||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||||0.926
70961914|NCT01794923|141428701|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.2||||0.743|TWO_SIDED|95.0|-29.51|21.1|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||21.10|-29.51|0.743
70961915|NCT01794923|141428701|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.8||||0.952|TWO_SIDED|95.0|-24.55|26.08|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||26.08|-24.55|0.952
70961916|NCT01794923|141428701|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.0||||0.719|TWO_SIDED|95.0|-32.25|22.3|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||22.30|-32.25|0.719
70961917|NCT01794923|141428701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.284|TWO_SIDED||||||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||||0.284
70961918|NCT01794923|141428701|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-19.0||||0.171|TWO_SIDED|95.0|-46.21|8.28|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||8.28|-46.21|0.171
70961919|NCT01794923|141428701|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.2||||0.875|TWO_SIDED|95.0|-25.08|29.42|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||29.42|-25.08|0.875
70961920|NCT01794923|141428701|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-21.1||||0.157|TWO_SIDED|95.0|-50.5|8.23|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||8.23|-50.50|0.157
70961921|NCT01794923|141428701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.699|TWO_SIDED||||||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||||0.699
70961922|NCT01794923|141428701|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-17.8||||0.433|TWO_SIDED|95.0|-62.58|26.9|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||26.90|-62.58|0.433
70961923|NCT01794923|141428701|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0||||0.966|TWO_SIDED|95.0|-45.73|43.78|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||43.78|-45.73|0.966
70961924|NCT01794923|141428701|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-16.9||||0.491|TWO_SIDED|95.0|-65.08|31.36|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||31.36|-65.08|0.491
70961925|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.219|TWO_SIDED||||||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.219
70881267|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.91||||0.1955|TWO_SIDED|80.0|-0.95|4.77|||Mixed Models Analysis|||Change from baseline at Day 113||4.77|-0.95|0.1955
70961926|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.214|TWO_SIDED|95.0|-0.37|0.08|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.08|-0.37|0.214
70961927|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.555|TWO_SIDED|95.0|-0.16|0.29|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.29|-0.16|0.555
70961928|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.09|TWO_SIDED|95.0|-0.45|0.03|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.03|-0.45|0.090
70961929|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.161|TWO_SIDED||||||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.161
70961930|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.056|TWO_SIDED|95.0|-0.55|0.01|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.01|-0.55|0.056
70961931|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.395|TWO_SIDED|95.0|-0.4|0.16|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.16|-0.40|0.395
70961932|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.324|TWO_SIDED|95.0|-0.45|0.15|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.15|-0.45|0.324
70961933|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.246|TWO_SIDED||||||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.246
70961934|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.094|TWO_SIDED|95.0|-0.68|0.05|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.05|-0.68|0.094
70961935|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.491|TWO_SIDED|95.0|-0.5|0.24|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.24|-0.50|0.491
70961936|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.359|TWO_SIDED|95.0|-0.58|0.21|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.21|-0.58|0.359
70961937|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.294|TWO_SIDED||||||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.294
70961938|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.136|TWO_SIDED|95.0|-0.74|0.1|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.10|-0.74|0.136
70961939|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.293|TWO_SIDED|95.0|-0.65|0.2|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.20|-0.65|0.293
70961940|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.682|TWO_SIDED|95.0|-0.55|0.36|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.36|-0.55|0.682
70961941|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.747|TWO_SIDED||||||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.747
70961942|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.592|TWO_SIDED|95.0|-0.6|0.34|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.34|-0.60|0.592
70961943|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.473|TWO_SIDED|95.0|-0.64|0.3|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.30|-0.64|0.473
70961944|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.866|TWO_SIDED|95.0|-0.46|0.55|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.55|-0.46|0.866
70881268|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.77||||0.7844|TWO_SIDED|80.0|-4.65|1.12|||Mixed Models Analysis|||Change from baseline at Day 113||1.12|-4.65|0.7844
70961945|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.776|TWO_SIDED||||||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.776
70961946|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.761|TWO_SIDED|95.0|-0.59|0.43|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.43|-0.59|0.761
70961947|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.477|TWO_SIDED|95.0|-0.69|0.33|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.33|-0.69|0.477
70961948|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.705|TWO_SIDED|95.0|-0.44|0.65|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.65|-0.44|0.705
70961949|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|TWO_SIDED||||||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.600
70961950|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.931|TWO_SIDED|95.0|-0.52|0.56|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.56|-0.52|0.931
70961951|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.381|TWO_SIDED|95.0|-0.78|0.3|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.30|-0.78|0.381
70961952|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.371|TWO_SIDED|95.0|-0.32|0.85|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.85|-0.32|0.371
70961953|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.67|TWO_SIDED||||||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.670
70961954|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.941|TWO_SIDED|95.0|-0.54|0.58|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.58|-0.54|0.941
70961955|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.437|TWO_SIDED|95.0|-0.78|0.34|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.34|-0.78|0.437
70961956|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.429|TWO_SIDED|95.0|-0.36|0.84|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.84|-0.36|0.429
70961957|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.484|TWO_SIDED||||||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.484
70961958|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.504|TWO_SIDED|95.0|-0.38|0.78|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.78|-0.38|0.504
70881269|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.49||||0.2973|TWO_SIDED|80.0|-2.11|5.08|||Mixed Models Analysis|||Change from baseline at Day 141||5.08|-2.11|0.2973
70881270|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.33||||0.3127|TWO_SIDED|80.0|-2.18|4.84|||Mixed Models Analysis|||Change from baseline at Day 141||4.84|-2.18|0.3127
70881271|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.16||||0.5227|TWO_SIDED|80.0|-3.67|3.36|||Mixed Models Analysis|||Change from baseline at Day 141||3.36|-3.67|0.5227
70881272|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.63||||0.7643|TWO_SIDED|80.0|-4.54|1.28|||Mixed Models Analysis|||Change from baseline at Day 169||1.28|-4.54|0.7643
70961959|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.528|TWO_SIDED|95.0|-0.77|0.4|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.40|-0.77|0.528
70881273|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.38||||0.7331|TWO_SIDED|80.0|-4.25|1.48|||Mixed Models Analysis|||Change from baseline at Day 169||1.48|-4.25|0.7331
70961960|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.229|TWO_SIDED|95.0|-0.24|1.01|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||1.01|-0.24|0.229
70961961|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.536|TWO_SIDED||||||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.536
70961962|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.728|TWO_SIDED|95.0|-0.49|0.7|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.70|-0.49|0.728
70961963|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.414|TWO_SIDED|95.0|-0.84|0.35|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.35|-0.84|0.414
70961964|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.28|TWO_SIDED|95.0|-0.29|0.99|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.99|-0.29|0.280
70961965|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.402|TWO_SIDED||||||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.402
70961966|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.513|TWO_SIDED|95.0|-0.41|0.81|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.81|-0.41|0.513
70961967|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.424|TWO_SIDED|95.0|-0.86|0.36|||ANOVA|||11 hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.36|-0.86|0.424
70961968|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.178|TWO_SIDED|95.0|-0.21|1.1|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||1.10|-0.21|0.178
70961969|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.442|TWO_SIDED||||||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.442
70961970|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.357|TWO_SIDED|95.0|-0.33|0.91|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.91|-0.33|0.357
70961971|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.675|TWO_SIDED|95.0|-0.75|0.49|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.49|-0.75|0.675
70961972|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.215|TWO_SIDED|95.0|-0.25|1.09|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||1.09|-0.25|0.215
70961973|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.643|TWO_SIDED||||||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.643
70961974|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.466|TWO_SIDED|95.0|-0.46|0.99|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.99|-0.46|0.466
70961975|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.818|TWO_SIDED|95.0|-0.81|0.64|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.64|-0.81|0.818
70961976|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.373|TWO_SIDED|95.0|-0.43|1.13|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||1.13|-0.43|0.373
70961977|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.984|TWO_SIDED||||||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.984
70961978|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.874|TWO_SIDED|95.0|-0.79|0.68|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.68|-0.79|0.874
70961979|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.99|TWO_SIDED|95.0|-0.73|0.74|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.74|-0.73|0.990
70961980|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.875|TWO_SIDED|95.0|-0.85|0.73|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.73|-0.85|0.875
70961981|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.841|TWO_SIDED||||||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.841
70961982|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.58|TWO_SIDED|95.0|-1.01|0.57|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.57|-1.01|0.580
70961983|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.958|TWO_SIDED|95.0|-0.81|0.77|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.77|-0.81|0.958
70961984|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.643|TWO_SIDED|95.0|-1.05|0.65|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.65|-1.05|0.643
70961985|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.299|TWO_SIDED||||||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.299
70961986|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-0.5||||0.23|TWO_SIDED|95.0|-1.26|0.31|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.31|-1.26|0.230
70961987|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.694|TWO_SIDED|95.0|-0.63|0.94|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.94|-0.63|0.694
70961988|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.14|TWO_SIDED|95.0|-1.48|0.21|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.21|-1.48|0.140
70961989|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.503|TWO_SIDED||||||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.503
70961990|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5||||0.262|TWO_SIDED|95.0|-1.28|0.35|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.35|-1.28|0.262
70881274|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.25||||0.4557|TWO_SIDED|80.0|-2.59|3.09|||Mixed Models Analysis|||Change from baseline at Day 169||3.09|-2.59|0.4557
70881275|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.29||||0.4549|TWO_SIDED|80.0|-2.97|3.55|||Mixed Models Analysis|||Change from baseline at Day 197||3.55|-2.97|0.4549
70881276|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.93||||0.3535|TWO_SIDED|80.0|-2.26|4.13|||Mixed Models Analysis|||Change from baseline at Day 197||4.13|-2.26|0.3535
70881277|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.65||||0.397|TWO_SIDED|80.0|-2.54|3.84|||Mixed Models Analysis|||Change from baseline at Day 197||3.84|-2.54|0.3970
70881278|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.78||||0.2714|TWO_SIDED|80.0|-1.99|5.55|||Mixed Models Analysis|||Change from baseline at Day 225||5.55|-1.99|0.2714
70881279|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.72||||0.2741|TWO_SIDED|80.0|-1.97|5.41|||Mixed Models Analysis|||Change from baseline at Day 225||5.41|-1.97|0.2741
70881280|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.06||||0.5084|TWO_SIDED|80.0|-3.74|3.62|||Mixed Models Analysis|||Change from baseline at Day 225||3.62|-3.74|0.5084
70961991|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.871|TWO_SIDED|95.0|-0.88|0.75|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.75|-0.88|0.871
70961992|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.373|TWO_SIDED|95.0|-1.27|0.48|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.48|-1.27|0.373
70961993|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.413|TWO_SIDED||||||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.413
70961994|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.317|TWO_SIDED|95.0|-1.22|0.4|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.40|-1.22|0.317
70961995|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.708|TWO_SIDED|95.0|-0.66|0.97|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.97|-0.66|0.708
70961996|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.202|TWO_SIDED|95.0|-1.44|0.31|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.31|-1.44|0.202
70961997|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19|TWO_SIDED||||||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.190
70961998|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7||||0.094|TWO_SIDED|95.0|-1.44|0.11|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.11|-1.44|0.094
70961999|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.96|TWO_SIDED|95.0|-0.8|0.76|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.76|-0.80|0.960
70962000|NCT01794923|141428702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.132|TWO_SIDED|95.0|-1.48|0.2|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.20|-1.48|0.132
70962001|NCT01794923|141428703|SUPERIORITY_OR_OTHER_LEGACY|||||||0.163|TWO_SIDED||||||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.163
70962002|NCT01794923|141428703|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.6||||0.162|TWO_SIDED|95.0|-1.86|11.02|||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||11.02|-1.86|0.162
70962003|NCT01794923|141428703|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.9||||0.559|TWO_SIDED|95.0|-8.42|4.57|||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||4.57|-8.42|0.559
70962004|NCT01794923|141428703|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.5||||0.066|TWO_SIDED|95.0|-0.44|13.45|||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||13.45|-0.44|0.066
70962005|NCT01794923|141428703|SUPERIORITY_OR_OTHER_LEGACY|||||||0.957|TWO_SIDED||||||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.957
70962006|NCT01794923|141428703|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.1||||0.864|TWO_SIDED|95.0|-11.2|13.33|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||13.33|-11.20|0.864
70962007|NCT01794923|141428703|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9||||0.883|TWO_SIDED|95.0|-13.3|11.45|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||11.45|-13.30|0.883
70962008|NCT01794923|141428703|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.0||||0.767|TWO_SIDED|95.0|-11.24|15.22|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||15.22|-11.24|0.767
70962009|NCT01794923|141428703|SUPERIORITY_OR_OTHER_LEGACY|||||||0.243|TWO_SIDED||||||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.243
70962010|NCT01794923|141428703|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-8.2||||0.176|TWO_SIDED|95.0|-20.12|3.7|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||3.70|-20.12|0.176
70962011|NCT01794923|141428703|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.0||||0.741|TWO_SIDED|95.0|-10.0|14.03|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||14.03|-10.00|0.741
70962012|NCT01794923|141428703|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-10.2||||0.118|TWO_SIDED|95.0|-23.07|2.62|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||2.62|-23.07|0.118
70962013|NCT01794923|141428703|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92|TWO_SIDED||||||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.920
70962014|NCT01794923|141428703|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.2||||0.685|TWO_SIDED|95.0|-24.64|16.23|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||16.23|-24.64|0.685
70962015|NCT01794923|141428703|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.4||||0.892|TWO_SIDED|95.0|-22.04|19.19|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||19.19|-22.04|0.892
70962016|NCT01794923|141428703|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.8||||0.804|TWO_SIDED|95.0|-24.82|19.25|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||19.25|-24.82|0.804
70962017|NCT01794923|141428704|SUPERIORITY_OR_OTHER_LEGACY|||||||0.533|TWO_SIDED||||||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMSM terms.||||0.533
70962018|NCT01794923|141428704|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.5||||0.266|TWO_SIDED|95.0|-0.38|1.38|||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMSM terms.||1.38|-0.38|0.266
70962019|NCT01794923|141428704|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.73|TWO_SIDED|95.0|-0.74|1.05|||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMSM terms.||1.05|-0.74|0.730
70962020|NCT01794923|141428704|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.479|TWO_SIDED|95.0|-0.61|1.3|||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMSM terms.||1.30|-0.61|0.479
70962021|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.189|TWO_SIDED||||||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.189
70962022|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.389|TWO_SIDED|95.0|-0.17|0.07|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.07|-0.17|0.389
70962023|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.273|TWO_SIDED|95.0|-0.05|0.19|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.19|-0.05|0.273
70962024|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.069|TWO_SIDED|95.0|-0.25|0.01|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.01|-0.25|0.069
70962025|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.716|TWO_SIDED||||||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.716
70962026|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.735|TWO_SIDED|95.0|-0.15|0.11|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.11|-0.15|0.735
70962027|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.414|TWO_SIDED|95.0|-0.19|0.08|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.08|-0.19|0.414
70962028|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.652|TWO_SIDED|95.0|-0.11|0.17|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.17|-0.11|0.652
70962029|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.622|TWO_SIDED||||||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.622
70962030|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.83|TWO_SIDED|95.0|-0.17|0.21|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.21|-0.17|0.830
70962031|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.442|TWO_SIDED|95.0|-0.26|0.11|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.11|-0.26|0.442
70962032|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.358|TWO_SIDED|95.0|-0.11|0.29|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.29|-0.11|0.358
70962033|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.714|TWO_SIDED||||||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.714
70962034|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.683|TWO_SIDED|95.0|-0.29|0.19|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.19|-0.29|0.683
70962035|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.413|TWO_SIDED|95.0|-0.34|0.14|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.14|-0.34|0.413
70962036|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.699|TWO_SIDED|95.0|-0.21|0.31|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.31|-0.21|0.699
70962037|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.244|TWO_SIDED||||||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.244
70962038|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.833|TWO_SIDED|95.0|-0.21|0.26|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.26|-0.21|0.833
70962039|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.156|TWO_SIDED|95.0|-0.41|0.07|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.07|-0.41|0.156
70962040|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.128|TWO_SIDED|95.0|-0.06|0.46|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.46|-0.06|0.128
70962041|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.359|TWO_SIDED||||||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.359
70962042|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.278|TWO_SIDED|95.0|-0.12|0.43|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.43|-0.12|0.278
70962043|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.699|TWO_SIDED|95.0|-0.33|0.22|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.22|-0.33|0.699
70962044|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.172|TWO_SIDED|95.0|-0.09|0.5|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.50|-0.09|0.172
70962045|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.515|TWO_SIDED||||||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.515
70962046|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.527|TWO_SIDED|95.0|-0.19|0.37|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.37|-0.19|0.527
70962047|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.545|TWO_SIDED|95.0|-0.37|0.19|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.19|-0.37|0.545
70962048|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.25|TWO_SIDED|95.0|-0.12|0.47|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.47|-0.12|0.250
70962049|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.568|TWO_SIDED||||||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.568
70962050|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.381|TWO_SIDED|95.0|-0.16|0.41|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.41|-0.16|0.381
70962051|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.863|TWO_SIDED|95.0|-0.31|0.26|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.26|-0.31|0.863
70962052|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.33|TWO_SIDED|95.0|-0.16|0.46|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.46|-0.16|0.330
70962053|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.167|TWO_SIDED||||||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.167
70962054|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.165|TWO_SIDED|95.0|-0.09|0.5|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.50|-0.09|0.165
70962055|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.564|TWO_SIDED|95.0|-0.39|0.21|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.21|-0.39|0.564
70962056|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.068|TWO_SIDED|95.0|-0.02|0.62|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.62|-0.02|0.068
70962057|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.131|TWO_SIDED||||||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.131
70962058|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.119|TWO_SIDED|95.0|-0.06|0.56|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.56|-0.06|0.119
70962059|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.616|TWO_SIDED|95.0|-0.39|0.23|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.23|-0.39|0.616
70962060|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.056|TWO_SIDED|95.0|-0.01|0.66|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.66|-0.01|0.056
70962061|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.255|TWO_SIDED||||||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.255
70962062|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.144|TWO_SIDED|95.0|-0.08|0.57|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.57|-0.08|0.144
70962063|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.935|TWO_SIDED|95.0|-0.34|0.31|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.31|-0.34|0.935
70962064|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.153|TWO_SIDED|95.0|-0.1|0.61|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.61|-0.10|0.153
70962065|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.128|TWO_SIDED||||||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.128
70962066|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.067|TWO_SIDED|95.0|-0.02|0.63|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.63|-0.02|0.067
70962067|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.999|TWO_SIDED|95.0|-0.33|0.33|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.33|-0.33|0.999
70962068|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.088|TWO_SIDED|95.0|-0.05|0.66|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.66|-0.05|0.088
70962069|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.195|TWO_SIDED||||||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.195
70962070|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.175|TWO_SIDED|95.0|-0.12|0.67|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.67|-0.12|0.175
70962071|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.61|TWO_SIDED|95.0|-0.5|0.3|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.30|-0.50|0.610
70962072|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.083|TWO_SIDED|95.0|-0.05|0.81|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.81|-0.05|0.083
70962073|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.884|TWO_SIDED||||||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.884
70962074|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.833|TWO_SIDED|95.0|-0.43|0.35|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.35|-0.43|0.833
70962075|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.62|TWO_SIDED|95.0|-0.49|0.29|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.29|-0.49|0.620
70962076|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.788|TWO_SIDED|95.0|-0.36|0.48|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.48|-0.36|0.788
70962077|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.755|TWO_SIDED||||||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.755
70962078|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.787|TWO_SIDED|95.0|-0.45|0.34|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.34|-0.45|0.787
70962079|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.455|TWO_SIDED|95.0|-0.56|0.25|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.25|-0.56|0.455
70962080|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.654|TWO_SIDED|95.0|-0.33|0.53|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.53|-0.33|0.654
70962081|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|TWO_SIDED||||||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.370
70962082|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.472|TWO_SIDED|95.0|-0.51|0.24|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.24|-0.51|0.472
70962083|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.427|TWO_SIDED|95.0|-0.23|0.53|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.53|-0.23|0.427
70962084|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.159|TWO_SIDED|95.0|-0.69|0.11|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.11|-0.69|0.159
70962085|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48|TWO_SIDED||||||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.480
70962086|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.238|TWO_SIDED|95.0|-0.59|0.15|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.15|-0.59|0.238
70962087|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.794|TWO_SIDED|95.0|-0.42|0.32|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.32|-0.42|0.794
70962088|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.395|TWO_SIDED|95.0|-0.57|0.23|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.23|-0.57|0.395
70962089|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|TWO_SIDED||||||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.400
70962090|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.176|TWO_SIDED|95.0|-0.61|0.11|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.11|-0.61|0.176
70962091|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.573|TWO_SIDED|95.0|-0.47|0.26|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.26|-0.47|0.573
70962092|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.466|TWO_SIDED|95.0|-0.53|0.24|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.24|-0.53|0.466
70962093|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.092|TWO_SIDED||||||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.092
70962094|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.086|TWO_SIDED|95.0|-0.67|0.04|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.04|-0.67|0.086
70962095|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.616|TWO_SIDED|95.0|-0.27|0.45|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.45|-0.27|0.616
70962096|NCT01794923|141428705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.04|TWO_SIDED|95.0|-0.79|-0.02|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||-0.02|-0.79|0.040
70962097|NCT01794923|141428706|SUPERIORITY_OR_OTHER_LEGACY|||||||0.751|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for baseline categorical PSR (BLPSR) and sex.||||0.751
70962098|NCT01794923|141428706|SUPERIORITY_OR_OTHER_LEGACY||Weighted Gamma Statistic|0.0||||0.696|TWO_SIDED|95.0|-0.28|0.2|||Cochran-Mantel-Haenszel|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for baseline categorical PSR (BLPSR) and sex.||0.20|-0.28|0.696
70962099|NCT01794923|141428706|SUPERIORITY_OR_OTHER_LEGACY||Weighted Gamma Statistic|0.0||||0.76|TWO_SIDED|95.0|-0.21|0.29|||Cochran-Mantel-Haenszel|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for baseline categorical PSR (BLPSR) and sex.||0.29|-0.21|0.760
70962100|NCT01794923|141428706|SUPERIORITY_OR_OTHER_LEGACY||Weighted Gamma Statistic|-0.1||||0.463|TWO_SIDED|95.0|-0.36|0.16|||Cochran-Mantel-Haenszel|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for baseline categorical PSR (BLPSR) and sex.||0.16|-0.36|0.463
70962101|NCT03318809|141428710|OTHER|Analysis of Variance|Ratio (Group 1/Group 2)|1.24|||||TWO_SIDED|90.0|0.73|2.1|||||The ratio and confidence interval (CI) are based on natural log scale data converted back to the original scale.|||2.10|0.73|
70962102|NCT03318809|141428711|OTHER|Analysis of Variance|Ratio (Group 1/Group 2)|1.41|||||TWO_SIDED|90.0|0.88|2.27|||||The ratio and CI are based on natural log scale data converted back to the original scale.|||2.27|0.88|
70962103|NCT03318809|141428714|OTHER|Analysis of Variance|Ratio (Group 1/Group 2)|1.24|||||TWO_SIDED|90.0|0.73|2.1|||||The ratio and CI are based on natural log scale data converted back to the original scale.|||2.10|0.73|
70962104|NCT00986440|141428741|SUPERIORITY||Z statistic for difference|3.92|||<|0.0001|TWO_SIDED||||||2-sided P value for z test|||||||<0.0001
70962105|NCT00986440|141428741|SUPERIORITY||Hazard Ratio, log|-0.41|||||TWO_SIDED|||||||||||||
70962106|NCT00986440|141428742|SUPERIORITY|||||||0.038|||||||Log Rank|||||||0.0380
70962107|NCT00986440|141428742|SUPERIORITY|||||||0.1773|||||||Peto-Peto-Prentice|||||||0.1773
70962108|NCT00986440|141428742|SUPERIORITY|||||||0.2844|||||||Wilcoxon (Mann-Whitney)|||||||0.2844
70962109|NCT00986440|141428742|SUPERIORITY|||||||0.114|||||||Tarone-Ware|||||||0.1140
70962110|NCT00986440|141428743|SUPERIORITY|||||||0.1213|||||||Log Rank|||||||0.1213
70962111|NCT02340091|141428769|SUPERIORITY||Subjects % with difference in VAS ≥ 10mm|0.9194|||||TWO_SIDED|95.0|0.8|0.97||||||||0.97|0.80|
70962112|NCT02460666|141428774|SUPERIORITY|||||||0.3|||||||Mixed Models Analysis|||||||0.3
70962113|NCT02460666|141428775|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.2
70962114|NCT02460666|141428776|SUPERIORITY|||||||0.5|||||||Mixed Models Analysis|||||||0.5
70962115|NCT02460666|141428777|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
70962116|NCT01323621|141428800|SUPERIORITY_OR_OTHER||Least squares mean difference|0.029||||0.267||95.0|-0.022|0.08|||ANCOVA||ANCOVA analysis was conducted with covariates for country, smoking status, reversibility, and Baseline FEV1.|||0.080|-0.022|0.267
70962117|NCT00292461|141428817|SUPERIORITY_OR_OTHER|||||||0.24|||||||ANOVA|||||||0.240
70962118|NCT00292461|141428818|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||Cochran-Mantel-Haenszel|||||||0.460
70962119|NCT00292461|141428819|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||Cochran-Mantel-Haenszel|||||||0.079
70962120|NCT00292461|141428820|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Cochran-Mantel-Haenszel|||||||0.860
70962121|NCT05629962|141428836|SUPERIORITY|||||||0.954|||||||Cochran-Mantel-Haenszel|||||||0.954
70962122|NCT05640648|141428843|OTHER||Incidence rate ratio|1.84|||<|0.001|TWO_SIDED|95.0|1.62|2.09|||Mixed Models Analysis|Mixed-effects Poisson model adjusting for time and group level (paired health centres, based on randomization) cluster||||2.09|1.62|<0.001
70962123|NCT05640648|141428844|OTHER||Incidence Rate Ratio|7.46||||0.002|TWO_SIDED|95.0|2.06|26.95|||Mixed Models Analysis|Mixed-effects Poisson model adjusting for time and group level (paired health centres, based on randomization) cluster||||26.95|2.06|0.002
70962124|NCT05640648|141428845|OTHER||Incidence Rate Ratio|1.25||||0.5|TWO_SIDED|95.0|0.65|2.42|||Mixed Models Analysis|Mixed effects poisson model adjusting for time and group (paired healthcentres, based on randomization)||||2.42|0.65|0.50
70962125|NCT05640648|141428848|OTHER||Incidence Rate Ratio|4.75|||<|0.001|TWO_SIDED|95.0|2.07|10.91|||Mixed Models Analysis|Mixed-effects Poisson model adjusting for time and group level (paired health centres, based on randomization) cluster||||10.91|2.07|<0.001
70962126|NCT04908189|141428850|SUPERIORITY||Adjusted Mean Difference|-0.4743|STANDARD_ERROR_OF_MEAN|0.08735|<|0.0001|TWO_SIDED|95.0|-0.6455|-0.3031|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|||-0.3031|-0.6455|<0.0001
70962127|NCT04908189|141428851|SUPERIORITY||Adjusted mean difference|-0.1126|STANDARD_ERROR_OF_MEAN|0.03511||0.0013|TWO_SIDED|95.0|-0.1814|-0.0438|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|||-0.0438|-0.1814|0.0013
70962128|NCT04908189|141428853|SUPERIORITY||Adjusted mean difference|2.042|STANDARD_ERROR_OF_MEAN|0.5421||0.0002|TWO_SIDED|95.0|0.98|3.105|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|||3.105|0.980|0.0002
70962129|NCT04908189|141428856|SUPERIORITY||Adjusted mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.61||0.2017|TWO_SIDED|95.0|-0.4|2.0|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|||2.0|-0.4|0.2017
70962130|NCT04908189|141428860|SUPERIORITY||Adjusted mean difference|0.0643|STANDARD_ERROR_OF_MEAN|0.02831||0.0231|TWO_SIDED|95.0|0.0088|0.1198|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 2||0.1198|0.0088|0.0231
70962131|NCT04908189|141428860|SUPERIORITY||Adjusted mean difference|0.0085|STANDARD_ERROR_OF_MEAN|0.03126||0.7865|TWO_SIDED|95.0|-0.0528|0.0697|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.0697|-0.0528|0.7865
70962132|NCT04908189|141428860|SUPERIORITY||Adjusted mean difference|-0.0515|STANDARD_ERROR_OF_MEAN|0.03386||0.128|TWO_SIDED|95.0|-0.1179|0.0148|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 8||0.0148|-0.1179|0.1280
70962133|NCT04908189|141428860|SUPERIORITY||Adjusted mean differnce|-0.0541|STANDARD_ERROR_OF_MEAN|0.0346||0.118|TWO_SIDED|95.0|-0.1219|0.0137|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||0.0137|-0.1219|0.1180
70962134|NCT04908189|141428860|SUPERIORITY||Adjusted mean difference|-0.1126|STANDARD_ERROR_OF_MEAN|0.03511||0.0013|TWO_SIDED|95.0|-0.1814|-0.0438|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||-0.0438|-0.1814|0.0013
70962135|NCT04908189|141428865|SUPERIORITY||Adjusted mean difference|0.692|STANDARD_ERROR_OF_MEAN|0.4384||0.1147|TWO_SIDED|95.0|-0.168|1.551|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||1.551|-0.168|0.1147
70962136|NCT04908189|141428865|SUPERIORITY||Adjusted mean difference|1.999|STANDARD_ERROR_OF_MEAN|0.5147||0.0001|TWO_SIDED|95.0|0.991|3.008|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||3.008|0.991|0.0001
70962137|NCT04908189|141428865|SUPERIORITY||Adjusted mean difference|2.042|STANDARD_ERROR_OF_MEAN|0.5421||0.0002|TWO_SIDED|95.0|0.98|3.105|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||3.105|0.980|0.0002
70962138|NCT04908189|141428869|SUPERIORITY||Adjusted mean difference|-0.284|STANDARD_ERROR_OF_MEAN|0.567||0.6159|TWO_SIDED|95.0|-1.396|0.827|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.827|-1.396|0.6159
70962139|NCT04908189|141428869|SUPERIORITY||Adjusted mean difference|0.829|STANDARD_ERROR_OF_MEAN|0.625||0.1847|TWO_SIDED|95.0|-0.396|2.054|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||2.054|-0.396|0.1847
70962140|NCT04908189|141428869|SUPERIORITY||Adjusted mean difference|1.145|STANDARD_ERROR_OF_MEAN|0.673||0.0888|TWO_SIDED|95.0|-0.174|2.464|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||2.464|-0.174|0.0888
70962141|NCT04908189|141428870|SUPERIORITY||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.49||0.1924|TWO_SIDED|95.0|-1.6|0.3|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 2||0.3|-1.6|0.1924
70962142|NCT04908189|141428870|SUPERIORITY||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.51||0.7601|TWO_SIDED|95.0|-1.2|0.8|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.8|-1.20|0.7601
70962143|NCT04908189|141428870|SUPERIORITY||Adjusted mean difference|1.3|STANDARD_ERROR_OF_MEAN|0.59||0.0303|TWO_SIDED|95.0|0.1|2.4|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 8||2.4|0.1|0.0303
70962144|NCT04908189|141428870|SUPERIORITY||Adjusted mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.63||0.4747|TWO_SIDED|95.0|-0.8|1.7|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||1.7|-0.8|0.4747
70962145|NCT04908189|141428870|SUPERIORITY||Adjusted mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.61||0.2017|TWO_SIDED|95.0|-0.4|2.0|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||2.0|-0.4|0.2017
70962146|NCT04908189|141428872|SUPERIORITY||Adjusted mean difference|-0.077|STANDARD_ERROR_OF_MEAN|0.1015||0.4459|TWO_SIDED|95.0|-0.276|0.122|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 2||0.122|-0.276|0.4459
70962147|NCT04908189|141428872|SUPERIORITY||Adjusted mean difference|-0.232|STANDARD_ERROR_OF_MEAN|0.1164||0.0461|TWO_SIDED|95.0|-0.46|-0.004|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||-0.004|-0.460|0.0461
70962148|NCT04908189|141428872|SUPERIORITY||Adjusted mean difference|-0.598|STANDARD_ERROR_OF_MEAN|0.1321|<|0.0001|TWO_SIDED|95.0|-0.857|-0.339|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 8||-0.339|-0.857|<0.0001
70881281|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.82||||0.1537|TWO_SIDED|80.0|-0.73|6.37|||Mixed Models Analysis|||Change from baseline at Day 253||6.37|-0.73|0.1537
70962149|NCT04908189|141428872|SUPERIORITY||Adjusted mean difference|-0.605|STANDARD_ERROR_OF_MEAN|0.1416|<|0.0001|TWO_SIDED|95.0|-0.882|-0.327|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||-0.327|-0.882|<0.0001
70962150|NCT04908189|141428872|SUPERIORITY||Adjusted mean difference|-0.786|STANDARD_ERROR_OF_MEAN|0.1455|<|0.0001|TWO_SIDED|95.0|-1.071|-0.501|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||-0.501|-1.071|<0.0001
70962151|NCT04908189|141428873|SUPERIORITY||Adjusted mean difference|0.3525|STANDARD_ERROR_OF_MEAN|0.9227||0.7025|TWO_SIDED|95.0|-1.456|2.1609|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 2||2.1609|-1.4560|0.7025
70962152|NCT04908189|141428873|SUPERIORITY||Adjusted mean difference|-1.373|STANDARD_ERROR_OF_MEAN|0.93331||0.1413|TWO_SIDED|95.0|-3.2023|0.4562|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.4562|-3.2023|0.1413
70962153|NCT04908189|141428873|SUPERIORITY||Adjused mean difference|-3.7522|STANDARD_ERROR_OF_MEAN|1.10374||0.0007|TWO_SIDED|95.0|-5.9155|-1.589|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 8||-1.5890|-5.9155|0.0007
70962154|NCT04908189|141428873|SUPERIORITY||Adjusted mean difference|-4.8072|STANDARD_ERROR_OF_MEAN|1.13857|<|0.0001|TWO_SIDED|95.0|-7.0388|-2.5757|||ANOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||-2.5757|-7.0388|<0.0001
70962155|NCT04908189|141428873|SUPERIORITY||Adjusted mean difference|-6.2006|STANDARD_ERROR_OF_MEAN|1.2284|<|0.0001|TWO_SIDED|95.0|-8.6082|-3.793|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||-3.7930|-8.6082|<0.0001
70962156|NCT04908189|141428877|SUPERIORITY||Adjusted mean difference|0.0318|STANDARD_ERROR_OF_MEAN|0.05613||0.5707|TWO_SIDED|95.0|-0.0782|0.1419|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 2||0.1419|-0.0782|0.5707
70962157|NCT04908189|141428877|SUPERIORITY||Adjusted mean difference|-0.0833|STANDARD_ERROR_OF_MEAN|0.06303||0.1862|TWO_SIDED|95.0|-0.2069|0.0402|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.0402|-0.2069|0.1862
70962158|NCT04908189|141428877|SUPERIORITY||Adjusted mean difference|-0.2958|STANDARD_ERROR_OF_MEAN|0.07854||0.0002|TWO_SIDED|95.0|-0.4497|-0.1418|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 8||-0.1418|-0.4497|0.0002
70962159|NCT04908189|141428877|SUPERIORITY||Adjusted mean difference|-0.3262|STANDARD_ERROR_OF_MEAN|0.083|<|0.0001|TWO_SIDED|95.0|-0.4889|-0.1635|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||-0.1635|-0.4889|<0.0001
70962160|NCT04908189|141428877|SUPERIORITY||Adjusted mean difference|-0.4743|STANDARD_ERROR_OF_MEAN|0.08735|<|0.0001|TWO_SIDED|95.0|-0.6455|-0.3031|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||-0.3031|-0.6455|<0.0001
70962161|NCT04908189|141428880|SUPERIORITY||Adjusted mean difference|-0.0758|STANDARD_ERROR_OF_MEAN|0.07069||0.2836|TWO_SIDED|95.0|-0.2144|0.0627|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.0627|-0.2144|0.2836
70962162|NCT04908189|141428880|SUPERIORITY||Adjusted mean difference|-0.5548|STANDARD_ERROR_OF_MEAN|0.09431|<|0.0001|TWO_SIDED|95.0|-0.7396|-0.3699|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||-0.3699|-0.7396|<0.0001
70962163|NCT04908189|141428880|SUPERIORITY||Adjusted mean difference|-0.5835|STANDARD_ERROR_OF_MEAN|0.10162|<|0.0001|TWO_SIDED|95.0|-0.7826|-0.3843|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||-0.3843|-0.7826|<0.0001
70962164|NCT04908189|141428881|SUPERIORITY||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.2143|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.1|-0.4|0.2143
70962165|NCT04908189|141428881|SUPERIORITY||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13||0.0001|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 8||-0.2|-0.8|0.0001
70962166|NCT04908189|141428881|SUPERIORITY||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.0|-0.4|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||-0.4|-1.0|<0.0001
70962167|NCT04908189|141428881|SUPERIORITY||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.9|-0.4|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||-0.4|-0.9|<0.0001
70881282|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.79||||0.2542|TWO_SIDED|80.0|-1.69|5.27|||Mixed Models Analysis|||Change from baseline at Day 253||5.27|-1.69|0.2542
70962168|NCT04908189|141428884|SUPERIORITY||Adjusted mean difference|-0.38|STANDARD_ERROR_OF_MEAN|1.801||0.8316|TWO_SIDED|95.0|-3.91|3.15|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Absenteeism||3.15|-3.91|0.8316
70962169|NCT04908189|141428884|SUPERIORITY||Adjusted mean difference|-2.95|STANDARD_ERROR_OF_MEAN|1.827||0.106|TWO_SIDED|95.0|-6.54|0.63|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Presenteeism||0.63|-6.54|0.1060
70962170|NCT04908189|141428884|SUPERIORITY||Adjusted mean difference|-2.71|STANDARD_ERROR_OF_MEAN|1.918||0.1578|TWO_SIDED|95.0|-6.47|1.05|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Work Productivity||1.05|-6.47|0.1578
70962171|NCT04908189|141428884|SUPERIORITY||Adjusted mean difference|-7.59|STANDARD_ERROR_OF_MEAN|1.719|<|0.0001|TWO_SIDED|95.0|-10.96|-4.22|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Activity Impairment||-4.22|-10.96|<0.0001
70962172|NCT04908189|141428885|SUPERIORITY||Adjusted mean difference|-0.0026|STANDARD_ERROR_OF_MEAN|0.01224||0.8487|TWO_SIDED|95.0|-0.0291|0.0239|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4 Utility Score||0.0239|-0.0291|0.8487
70962173|NCT04908189|141428885|SUPERIORITY||Adjusted mean difference|0.0365|STANDARD_ERROR_OF_MEAN|0.01531||0.0171|TWO_SIDED|95.0|0.0065|0.0665|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16 Utility Score||0.0665|0.0065|0.0171
70962174|NCT04908189|141428885|SUPERIORITY||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.9254|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4 Mobility||0.1|-0.1|0.9254
70962175|NCT04908189|141428885|SUPERIORITY||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.06||0.0566|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16 Mobility||0.0|-0.2|0.0566
70962176|NCT04908189|141428885|SUPERIORITY||Ajudted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.8933|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4 Self-Care||0.1|-0.1|0.8933
70962177|NCT04908189|141428885|SUPERIORITY||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.05||0.0738|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16 Self-Care||0.0|-0.2|0.0738
70962178|NCT04908189|141428885|SUPERIORITY||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.6176|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4 Usual Activities||0.1|-0.1|0.6176
70962179|NCT04908189|141428885|SUPERIORITY||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.06||0.1544|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16 Usual Activities||0.0|-0.2|0.1544
70962180|NCT04908189|141428885|SUPERIORITY||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.4707|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4 Pain/Discomfort||0.1|-0.2|0.4707
70962181|NCT04908189|141428885|SUPERIORITY||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.06||0.0114|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16 Pain/Discomfort||0.0|-0.3|0.0114
70881283|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.03||||0.6504|TWO_SIDED|80.0|-4.46|2.4|||Mixed Models Analysis|||Change from baseline at Day 253||2.40|-4.46|0.6504
70962182|NCT04908189|141428885|SUPERIORITY||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.6594|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4 Anxiety/Depression||0.1|-0.1|0.6594
70962183|NCT04908189|141428885|SUPERIORITY||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.7123|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16 Anxiety/Depression||0.1|-0.1|0.7123
70962184|NCT04908189|141428886|SUPERIORITY||Adjusted mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.498||0.9834|TWO_SIDED|95.0|-0.99|0.97|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.97|-0.99|0.9834
70962185|NCT04908189|141428886|SUPERIORITY||Adjusted mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.565||0.6099|TWO_SIDED|95.0|-1.39|0.82|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||0.82|-1.39|0.6099
70962186|NCT04908189|141428886|SUPERIORITY||Adjusted mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.538||0.2205|TWO_SIDED|95.0|-1.71|0.4|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||0.40|-1.71|0.2205
70962187|NCT02083705|141428900|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||"We hypothesised that during neonatal CPR, CC+SI will reduce the time needed to achieve ROSC. Our aim was to examine if CC+SI reduces ROSC compared with 3:1 C:V CPR in preterm infants \<33 weeks of gestation.~For this pilot study, based on the local incidence of CPR in preterm neonates, a convenient sample size of five patients per group was enrolled. Our primary outcome was time to achieve ROSC measured using ECG."||||0.05
70962188|NCT01839487|141428909|OTHER||Hazard Ratio (HR)|0.74||||0.058|TWO_SIDED|95.0|0.54|1.01||Threshold for significance at 0.1 level.|Log Rank|P-value was based on stratified log-rank test with the KPS category at screening as the stratification factor.||Hazard ratio PAG/AG was based on Cox proportional hazards model stratified by the Karnofsky Performance Status (KPS) category (70-80% and 90-100%) at screening using AG as the reference arm.||1.01|0.54|0.058
70962189|NCT01839487|141428911|OTHER||Hazard Ratio (HR)|0.57||||0.092|TWO_SIDED|95.0|0.3|1.1||Threshold for significance at 0.1 level.|Log Rank|P-value was based on stratified log-rank test with the KPS category at screening as the stratification factor.||Hazard ratio PAG/AG for HA-high was based on Cox proportional hazards model stratified by the KPS category (70-80% and 90-100%) at screening using AG as the reference arm.||1.10|0.30|0.092
70962190|NCT01839487|141428911|OTHER||Hazard Ratio (HR)|0.88||||0.514|TWO_SIDED|95.0|0.59|1.31||Threshold for significance at 0.1 level.|Log Rank|P-value was based on stratified log-rank test with the KPS category at screening as the stratification factor.||Hazard ratio PAG/AG for HA-low was based on Cox proportional hazards model stratified by the KPS category (70-80% and 90-100%) at screening using AG as the reference arm.||1.31|0.59|0.514
70962191|NCT01839487|141428912|OTHER||Risk Ratio (RR)|1.22||||0.225|TWO_SIDED|95.0|0.88|1.68||Threshold for significance at 0.1 level.|Cochran-Mantel-Haenszel|||p-Value and relative risk were based on a stratified Cochran-Mantel-Haenszel method using KPS category at screening as the stratification factor.||1.68|0.88|0.225
70962192|NCT01839487|141428913|OTHER||Hazard Ratio (HR)|0.91||||0.495|TWO_SIDED|95.0|0.7|1.19||Threshold for significance at 0.1 level.|Log Rank|P-value was based on stratified log-rank test with the KPS category at screening as the stratification factor.||Hazard ratio PAG/AG was based on Cox proportional hazards model stratified by the KPS category (70-80% and 90-100%) at screening using AG as the reference arm.||1.19|0.70|0.495
70962193|NCT00475033|141428921|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|-2.4|||||TWO_SIDED|95.0|-5.3|-0.1|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|Meningococcal C: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||-0.1|-5.3|
70962194|NCT00475033|141428922|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.19|||||TWO_SIDED|95.0|0.96|1.48|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Ratio of GMs (13vPnC, 7vPnC)||1.48|0.96|
70962195|NCT00475033|141428923|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.6|1.7|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|PT: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||1.7|-1.6|
70962196|NCT00475033|141428923|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.3|1.3|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|FHA: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||1.3|-1.3|
70962197|NCT00475033|141428923|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|1.1|||||TWO_SIDED|95.0|-1.7|4.2|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|PRN: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||4.2|-1.7|
70962198|NCT00475033|141428923|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|-2.1|||||TWO_SIDED|95.0|-5.5|1.2|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|FIM: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage||1.2|-5.5|
70962199|NCT00475033|141428924|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.4|1.4|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|Meningococcal C: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||1.4|-1.4|
70962200|NCT00475033|141428925|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.27|||||TWO_SIDED|95.0|1.08|1.5|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Meningococcal C: Ratio of geometric means (13vPnC, 7vPnC)||1.50|1.08|
70962201|NCT00475033|141428930|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.14|||||TWO_SIDED|95.0|1.02|1.27|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|PT: Ratio of geometric means (13vPnC, 7vPnC)||1.27|1.02|
70962202|NCT00475033|141428930|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.12|||||TWO_SIDED|95.0|1.01|1.25|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|FHA: Ratio of geometric means (13vPnC, 7vPnC)||1.25|1.01|
70962203|NCT00475033|141428930|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.05|||||TWO_SIDED|95.0|0.89|1.24|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|PRN: Ratio of geometric means (13vPnC, 7vPnC)||1.24|0.89|
70962204|NCT00475033|141428930|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.89|||||TWO_SIDED|95.0|0.78|1.02|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|FIM: Ratio of geometric means (13vPnC, 7vPnC)||1.02|0.78|
70962205|NCT00475033|141428931|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|-1.8|||||TWO_SIDED|95.0|-4.4|0.1|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||0.1|-4.4|
70962206|NCT00475033|141428932|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.91|||||TWO_SIDED|95.0|0.75|1.12|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|PRP in Hib: Ratio of geometric means (13vPnC, 7vPnC)||1.12|0.75|
70962207|NCT00475033|141428933|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|-3.0|||||TWO_SIDED|95.0|-9.4|3.4|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|PRP: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||3.4|-9.4|
70962208|NCT04356183|141428956|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
70962209|NCT04356183|141428957|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
70962210|NCT04356183|141428958|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
70962211|NCT01570036|141428959|OTHER|Kaplan-Meier Survival Analysis|Hazard Ratio (HR)|0.62||||0.18|TWO_SIDED|95.0|0.31|1.25|||Kaplan-Meier Survival Analysis|||||1.25|.31|0.18
70962212|NCT01570036|141428961|OTHER|||||||0.02||||||Comparison of the mean LVEF from baseline to 3 months, 6 months, and 12 months; this time period includes the therapy period of trastuzumab.|ANOVA|||||||0.02
70962213|NCT01570036|141428961|OTHER|||||||0.58||||||The mean LVEF compared at baseline to 3 months, 6 months, 12 months and 24 months; this time period includes the duration of trastuzumab therapy and 1 year after completion of trastuzumab therapy.|ANOVA|||||||0.58
70962214|NCT01570036|141428961|OTHER|||||||0.65||||||Evaluating LVEF at all time points with a linear mixed regression model, this analysis compared cardiac ejection fraction over time.|Regression, Linear|||||||0.65
70962215|NCT01570036|141428961|OTHER|||||||0.91||||||This analysis evaluated LVEF at all time points with a linear mixed regression model between randomization arms.|Regression, Linear|||||||0.91
70962216|NCT01570036|141428961|OTHER|||||||0.81||||||This analysis evaluated LVEF at all time points with a linear mixed regression model between the arms over time.|Regression, Linear|||||||0.81
70962217|NCT01570036|141428962|OTHER|||||||0.149|||||||Chi-squared|Comparison of the maximum related local toxicity experienced per patient and compared between treatment arms.||The safety group consisted of any patients who received NPS with GM-CSF or placebo with GM-CSF inoculations.||||0.149
70962218|NCT01570036|141428962|OTHER|||||||0.901|||||||Chi-squared|Comparison of the maximum related systemic toxicity experienced per patient and compared between treatment arms.||||||0.901
70962219|NCT00823901|141429002|SUPERIORITY_OR_OTHER|||||||0.15|||||||t-test, 2 sided|||||||0.15
70962220|NCT01369511|141429003|SUPERIORITY_OR_OTHER|||||||0.527|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 12||||0.527
70962221|NCT01369511|141429003|SUPERIORITY_OR_OTHER|||||||0.291|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 12||||0.291
70962222|NCT01369511|141429003|SUPERIORITY_OR_OTHER|||||||0.129|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 12||||0.129
70962223|NCT01369511|141429004|SUPERIORITY_OR_OTHER|||||||0.751|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 8||||0.751
70962224|NCT01369511|141429004|SUPERIORITY_OR_OTHER|||||||0.066|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 8||||0.066
70962225|NCT01369511|141429004|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 8||||0.031
70962226|NCT01369511|141429004|SUPERIORITY_OR_OTHER|||||||0.315|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 16||||0.315
70962227|NCT01369511|141429004|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 16||||0.002
70962228|NCT01369511|141429004|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 16||||0.007
70962229|NCT01376349|141429010|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
70962230|NCT01376349|141429010|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
70962231|NCT01176968|141429014|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.581|||<|0.0001|TWO_SIDED|95.0|0.446|0.756||All analyses for primary endpoint were tested at two-sided, α-level of 0.05, without adjusting for multiplicity.|Regression, Cox|||Hazard ratio, 95% confidence interval (CI) of hazard ratio, and p-value for the Primary Analysis based on a Cox proportional hazard model with treatment as the major factor, adjusted for baseline estimated glomerular filtration rate (eGFR), with/without previous MI, time of first dose administered post onset of index symptom, and location of index MI anterior or non-anterior.||0.756|0.446|< 0.0001
70962232|NCT01176968|141429015|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.562||||0.6406|TWO_SIDED|95.0|0.05|6.308|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as the major factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.||6.308|0.050|0.6406
70962233|NCT01176968|141429016|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.726||||0.5338|TWO_SIDED|95.0|0.265|1.99|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as a factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.||1.990|0.265|0.5338
70962234|NCT01176968|141429018|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.083||||0.8042|TWO_SIDED|95.0|0.575|2.04|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as the major factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.||2.040|0.575|0.8042
70962235|NCT01176968|141429019|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.598||||0.0003|TWO_SIDED|95.0|0.452|0.791|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as a factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.||0.791|0.452|0.0003
70962236|NCT01176968|141429020|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.069||||0.9353|TWO_SIDED|95.0|0.213|5.371|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as a factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.||5.371|0.213|0.9353
70962237|NCT01176968|141429021|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.6||||0.3757|TWO_SIDED|95.0|0.566|4.525|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as the major factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.||4.525|0.566|0.3757
70962238|NCT01176968|141429022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.45||||0.1744|TWO_SIDED|95.0|-3.55|0.65|||ANCOVA|||ANCOVA model was used with observed value as the dependent variable, treatment as a major factor, and baseline QRS duration, baseline eGFR, with/without previous MI, time (in hours) of first dose administered post onset of index symptom, and location of index MI (anterior versus all other locations) as covariates.||0.65|-3.55|0.1744
70962239|NCT01176968|141429023|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.7123|TWO_SIDED|95.0|-0.1|0.14||ANCOVA was used for between-treatment comparisons of the LSMeans, 95% CI of LSMEANS, LSMeans difference, 95% CI of LSMeans difference, and p-value with observed value at the given time point as variable.|ANCOVA|||For the Between-Treatment difference for Eplerenone and Placebo groups of observed value taken at Month 6 visit, ANCOVA model was performed for LAD based on the LOCF method including treatment groups with/without adjustments for baseline eGFR (in mL/min/1.73 m2), previous MI (yes/no), time (in hours) of first dose administered post-onset of symptom, index MI location (anterior versus all others) as covariates.||0.14|-0.10|0.7123
70962240|NCT01176968|141429023|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04||||0.4105|TWO_SIDED|95.0|-0.05|0.13||ANCOVA was used for between-treatment comparisons of the LSMeans, 95% CI of LSMEANS, LSMeans difference, 95% CI of LSMeans difference, and p-value with observed value at the given time point as variable.|ANCOVA|||For the Between-Treatment difference for Eplerenone and Placebo groups of observed value taken at Month 6 visit, ANCOVA model was performed for LAD based on the LOCF method including treatment groups with/without adjustments for baseline eGFR (in mL/min/1.73 m2), previous MI (yes/no), time (in hours) of first dose administered post-onset of symptom, index MI location (anterior versus all others) as covariates.||0.13|-0.05|0.4105
70962241|NCT01176968|141429024|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Aldosterone, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
70962242|NCT01176968|141429024|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.5552|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Aldosterone, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.5552
70962243|NCT01176968|141429024|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Wilcoxon Rank-Sum test|||For Biomarker- Aldosterone, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||< 0.0001
70962244|NCT01176968|141429024|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Serum Cortisol, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
70962245|NCT01176968|141429024|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Serum Cortisol, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
70962246|NCT01176968|141429024|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3347|TWO_SIDED||||||Wilcoxon Rank-Sum test|||For Biomarker- Serum Cortisol, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||0.3347
70962247|NCT01176968|141429025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005|TWO_SIDED||||||Signed Rank Test|||For Biomarker- PIIINP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||0.0005
70962248|NCT01176968|141429025|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- PIIINP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
70962249|NCT01176968|141429025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1558|TWO_SIDED||||||Wilcoxon-Rank Sum test|||For Biomarker- PIIINP, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||0.1558
70962250|NCT01176968|141429025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Galecting 3, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||0.0008
70962251|NCT01176968|141429025|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Galecting 3, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
70962252|NCT01176968|141429025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0293|TWO_SIDED||||||Wilcoxon Rank-Sum test|||For Biomarker- Galecting 3, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||0.0293
70962253|NCT01176968|141429025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1723|TWO_SIDED||||||Signed Rank Test|||For Biomarker- PINP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||0.1723
70962254|NCT01176968|141429025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0295|TWO_SIDED||||||Signed Rank Test|||For Biomarker- PINP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||0.0295
70962255|NCT01176968|141429025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0865|TWO_SIDED||||||Wilcoxon Rank-Sum test|||For Biomarker- PINP, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||0.0865
70962256|NCT01176968|141429026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0944|TWO_SIDED||||||Signed Rank Test|||For Biomarker- ICTP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||0.0944
70962257|NCT01176968|141429026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036|TWO_SIDED||||||Signed Rank Test|||For Biomarker- ICTP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||0.0360
70962258|NCT01176968|141429026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6459|TWO_SIDED||||||Wilcoxon Rank-Sum test|||For Biomarker- ICTP, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||0.6459
70962259|NCT01176968|141429027|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Interleukin-6, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
70962260|NCT01176968|141429027|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Interleukin-6, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
70962261|NCT01176968|141429027|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0801|TWO_SIDED||||||Wilcoxon Rank-Sum test|||For Biomarker- Interleukin-6, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||0.0801
70962262|NCT05193500|141429034|OTHER|||||||0.085||||||a priori threshold for statistical significance is 0.05|t-test, 2 sided|one-sample t-test, compared to 0.5 (chance)||||||0.085
70962263|NCT05193500|141429034|OTHER|||||||0.049||||||a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.049
70962264|NCT05193500|141429035|OTHER|||||||0.015||||||a priori threshold for statistical significance = 0.05|t-test, 2 sided|||||||0.015
70962265|NCT01324323|141429065|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean (%)|179.3|||||TWO_SIDED|90.0|160.3|200.7|||ANOVA||"Ratio (Romidepsin + rifampin/Romidepsin) and 90% CI of the ratio of geometric means are from an ANOVA model with treatment as fixed effect and subject as random effect on the natural log transformed PK values."|||200.7|160.3|
70962266|NCT01324323|141429066|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean|178.3|||||TWO_SIDED|90.0|159.4|199.4|||ANOVA||"Ratio (Romidepsin + rifampin/Romidepsin) and 90% CI of the ratio of geometric means are from an ANOVA model with treatment as fixed effect and subject as random effect on the natural log transformed PK values."|||199.4|159.4|
70962267|NCT01324323|141429067|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean|179.6|||||TWO_SIDED|90.0|160.5|201.0|||ANOVA||"Ratio (Romidepsin + rifampin/Romidepsin) and 90% CI of the ratio of geometric means are from an ANOVA model with treatment as fixed effect and subject as random effect on the natural log transformed PK values."|||201.0|160.5|
70962268|NCT01324323|141429068|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean|159.1|||||TWO_SIDED|90.0|135.8|186.5|||ANOVA||"Ratio (Romidepsin + rifampin/Romidepsin) and 90% CI of the ratio of geometric means are from an ANOVA model with treatment as fixed effect and subject as random effect on the natural log transformed PK values."|||186.5|135.8|
70962269|NCT01324323|141429069|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.15||||0.791|TWO_SIDED|90.0|-1.0|1.01|||Wilcoxon signed-rank|||"Note: The median, median difference (romidepsin + rifampin minus romidepsin) and 90% CI of the median difference are from Hodges-Lehmann Estimate. The P-value is from Wilcoxon signed-rank test."||1.01|-1.0|0.7910
70962270|NCT01821378|141429074|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.1||||0.255|TWO_SIDED|95.0|-8.4|2.2|||Mixed Models Analysis|||||2.2|-8.4|0.255
70962271|NCT01821378|141429074|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-10.3|||<|-0.001|TWO_SIDED|95.0|-14.9|-5.7|||Mixed Models Analysis|||||-5.7|-14.9|<-0.001
70962272|NCT01821378|141429075|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.2||||0.169|TWO_SIDED|95.0|-0.49|0.09|||Mixed Models Analysis|||||0.09|-0.49|0.169
70962273|NCT01821378|141429075|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.57|||<|0.001|TWO_SIDED|95.0|-0.83|-0.32|||Mixed Models Analysis|||||-0.32|-0.83|<0.001
70962274|NCT01821378|141429076|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.3||||0.706|TWO_SIDED|95.0|-1.8|1.2|||ANCOVA|||||1.2|-1.8|0.706
70962275|NCT01821378|141429076|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.0||||0.003|TWO_SIDED|95.0|-3.3|-0.7|||ANCOVA|||||-0.7|-3.3|0.003
70962276|NCT01821378|141429077|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.173|TWO_SIDED|95.0|0.8|2.5|||Regression, Logistic|||||2.5|0.8|0.173
70962277|NCT01821378|141429077|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.2|||<|0.001|TWO_SIDED|95.0|2.0|5.2|||Regression, Logistic|||||5.2|2.0|<0.001
70962278|NCT01821378|141429078|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-7.7||||0.023|TWO_SIDED|95.0|-14.3|-1.1|||Mixed Models Analysis|||||-1.1|-14.3|0.023
70962279|NCT01821378|141429079|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.8||||0.464|TWO_SIDED|95.0|-2.9|1.3|||ANCOVA|||||1.3|-2.9|0.464
70962280|NCT01821378|141429079|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.8||||0.122|TWO_SIDED|95.0|-4.1|0.5|||ANCOVA|||||0.5|-4.1|0.122
70962281|NCT01821378|141429080|SUPERIORITY_OR_OTHER||Least Square Mean Difference|2.3||||0.258|TWO_SIDED|95.0|-1.7|6.2|||Mixed Models Analysis|||||6.2|-1.7|0.258
70962282|NCT01821378|141429080|SUPERIORITY_OR_OTHER||Slope|6.6|||<|0.001|TWO_SIDED|95.0|3.2|10.1|||Mixed Models Analysis|||||10.1|3.2|<0.001
70962283|NCT01821378|141429081|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.35||||0.052|TWO_SIDED|95.0|-0.7|0.0|||Mixed Models Analysis|||||0.00|-0.70|0.052
70962284|NCT01821378|141429082|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.084||||0.012|TWO_SIDED|95.0|0.018|0.149|||ANCOVA|||||0.149|0.018|0.012
70962285|NCT01821378|141429082|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.138|||<|0.001|TWO_SIDED|95.0|0.081|0.194|||ANCOVA|||||0.194|0.081|<0.001
70962286|NCT01821378|141429083|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.0||||0.992|TWO_SIDED|95.0|-6.6|6.6|||Mixed Models Analysis|||||6.6|-6.6|0.992
70962287|NCT01821378|141429083|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-7.3||||0.044|TWO_SIDED|95.0|-14.4|-0.2|||Mixed Models Analysis|||||-0.2|-14.4|0.044
70962288|NCT01821378|141429084|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.1||||0.578|TWO_SIDED|95.0|-0.45|0.25|||Mixed Models Analysis|||||0.25|-0.45|0.578
70962289|NCT01821378|141429084|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.58||||0.003|TWO_SIDED|95.0|-0.96|-0.2|||Mixed Models Analysis|||||-0.20|-0.96|0.003
70962290|NCT02888665|141429086|OTHER||see above|||||||||||see above. target ORR was not met.|||see above. target ORR was not met.|The primary objective of the phase II design compared ORR with historical rates (Judson et al. Lancet Onc., 2014). A 2-stage design with null hypothesis of 15% using a 1-sided 0.05 α level test has 85% power to detect an increase to 35%. This required up to 35 patients. After 2 responses in stage 1 (20 pts), the study moved to stage 2 (15 pts). If 10 responses were seen (29%), this would have ruled out an ORR of 15%. The study was closed when it became clear we would not meet this benchmark.|see above. target ORR was not met.|||
70881284|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.3||||0.3405|TWO_SIDED|80.0|-2.78|5.38|||Mixed Models Analysis|||Change from baseline at Day 281||5.38|-2.78|0.3405
70962291|NCT01498289|141429140|SUPERIORITY||Cox Proportional Hazard|0.91||||0.83|TWO_SIDED|95.0|0.41|2.05|||Regression, Cox|||||2.05|0.41|0.83
70962292|NCT01498289|141429141|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.02|TWO_SIDED|95.0|0.5|0.93|||Regression, Cox|||||0.93|0.50|0.02
70962293|NCT01498289|141429142|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.2|TWO_SIDED|95.0|0.61|1.11|||Regression, Cox|||||1.11|0.61|0.20
70881285|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.41||||0.2194|TWO_SIDED|80.0|-1.59|6.42|||Mixed Models Analysis|||Change from baseline at Day 281||6.42|-1.59|0.2194
70881286|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.11||||0.3596|TWO_SIDED|80.0|-2.87|5.09|||Mixed Models Analysis|||Change from baseline at Day 281||5.09|-2.87|0.3596
70962294|NCT01498289|141429143|SUPERIORITY|||||||0.1|||||||Chi-squared|||||||0.10
70962295|NCT01498289|141429144|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.41|TWO_SIDED|95.0|0.44|1.4|||Regression, Cox|||Statistical analysis for Q1 ERCC1||1.40|0.44|0.41
70962296|NCT01498289|141429144|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.06|TWO_SIDED|95.0|0.32|1.02|||Regression, Cox|||Statistical analysis for Q2 ERCC1||1.02|0.32|0.06
70962297|NCT01498289|141429144|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.66|TWO_SIDED|95.0|0.49|1.58|||Regression, Cox|||Statistical analysis for Q3 ERCC1||1.58|0.49|0.66
70962298|NCT01498289|141429144|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.3|TWO_SIDED|95.0|0.42|1.31|||Regression, Cox|||Statistical analysis for Q4 ERCC1||1.31|0.42|0.30
70962299|NCT04526197|141429152|OTHER|Confidence Interval|Ratio of geometric LS means|0.881|||||TWO_SIDED|90.0|0.776|1.001||||||||1.001|0.776|
70962300|NCT04526197|141429153|OTHER|Confidence Interval|Ratio of geometric LS means|1.016|||||TWO_SIDED|90.0|0.959|1.077||||||||1.077|0.959|
70962301|NCT04526197|141429154|OTHER|Confidence Interval|Ratio of geometric LS means|1.01|||||TWO_SIDED|90.0|0.954|1.07||||||||1.070|0.954|
70962302|NCT00372385|141429158|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.758||||0.0026|TWO_SIDED|95.0|1.424|5.34|||Regression, Logistic|||||5.340|1.424|0.0026
70962303|NCT00372385|141429158|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.709||||0.959|TWO_SIDED|95.0|0.91|3.212|||Regression, Logistic|||||3.212|0.910|0.959
70962304|NCT00372385|141429158|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.589||||0.1089|TWO_SIDED|95.0|0.309|1.125|||Regression, Logistic|||||1.125|0.309|0.1089
70962305|NCT00372385|141429159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.632||||0.0041|TWO_SIDED|95.0|1.359|5.097|||Regression, Logistic|||||5.097|1.359|0.0041
70962306|NCT00372385|141429159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.623||||0.1324|TWO_SIDED|95.0|0.864|3.05|||Regression, Logistic|||||3.050|0.864|0.1324
70962307|NCT00372385|141429159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.591||||0.1099|TWO_SIDED|95.0|0.311|1.126|||Regression, Logistic|||||1.126|0.311|0.1099
70962308|NCT01699789|141429164|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.74|||||TWO_SIDED|95.0|0.57|0.95||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||0.95|0.57|
70962309|NCT01699789|141429165|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.48|1.26||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.26|0.48|
70962310|NCT01699789|141429166|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.61|0.97||||||Intent-to-treat analyses of repeated measures were developed including all participants with data at baseline, 6-month, or 12-month. Missing data were imputed. A generalized estimating equation (GEE) with a logit link function was used with adjustment for covariates.|In an analysis of change from baseline in likelihood of Poor Mental Health Quality of Life, CEP showed a significant advantage at 6 months, but not at 12 months.|0.97|0.61|
70962311|NCT01699789|141429167|SUPERIORITY||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|0.7|2.3||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients at 3 years to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.3|0.7|
70962312|NCT01699789|141429168|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.6|1.7||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients at 3 years to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.7|0.6|
70962313|NCT01699789|141429169|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.75|||||TWO_SIDED|95.0|1.19|2.59||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.59|1.19|
70962314|NCT01699789|141429170|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.45|||||TWO_SIDED|95.0|1.03|2.04||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.04|1.03|
70962315|NCT01699789|141429171|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|1.14|1.98||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.98|1.14|
70962316|NCT01699789|141429172|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.61|||||TWO_SIDED|95.0|0.38|0.96||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||0.96|0.38|
70962317|NCT01699789|141429173|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09|||||TWO_SIDED|95.0|0.69|1.7||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.70|0.69|
70962318|NCT01699789|141429174|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.59|||||TWO_SIDED|95.0|0.32|1.09||||||Adjusted analyses used multiply imputed data (N= 249), weighted for eligible sample for enrollment; logistic regression model adjusted for baseline and covariates and accounted for the design effect of the cluster randomization.||1.09|0.32|
70962319|NCT01699789|141429175|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.51|||||TWO_SIDED|95.0|0.28|0.95||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||0.95|0.28|
70962320|NCT01699789|141429176|SUPERIORITY||Odds Ratio (OR)|0.34|||||TWO_SIDED|95.0|0.14|0.88||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||0.88|0.14|
70962321|NCT01699789|141429177|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.52|1.25|||||Median cut point for baseline variable.|Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.25|0.52|
70962322|NCT01699789|141429178|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.69|1.41||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition||1.41|0.69|
70962323|NCT01699789|141429179|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.7|1.46||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.46|0.70|
70881287|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.07||||0.5086|TWO_SIDED|80.0|-4.04|3.9|||Mixed Models Analysis|||Change from baseline at Day 309||3.90|-4.04|0.5086
70881288|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.33||||0.2211|TWO_SIDED|80.0|-1.57|6.23|||Mixed Models Analysis|||Change from baseline at Day 309||6.23|-1.57|0.2211
70881289|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.4||||0.2126|TWO_SIDED|80.0|-1.47|6.26|||Mixed Models Analysis|||Change from baseline at Day 309||6.26|-1.47|0.2126
70881290|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.56||||0.2053|TWO_SIDED|80.0|-1.44|6.55|||Mixed Models Analysis|||Change from baseline at Day 337||6.55|-1.44|0.2053
70962324|NCT01699789|141429180|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.63|||<|0.01|TWO_SIDED|95.0|1.4|4.94|||Regression, Logistic|||Adjusted analyses used multiply imputed data (N=298), weighted for eligible sample for enrollment; logistic regression model adjusted for baseline and covariates and accounted for the design effect of the cluster randomization.||4.94|1.40|<.01
70962325|NCT01699789|141429181|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.66|1.21||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a generalized estimating equation logistic regression model adjusted for covariates, accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.21|0.66|
70962326|NCT01699789|141429182|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.61|1.4||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.40|0.61|
70962327|NCT01699789|141429183|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.34|1.25||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.25|0.34|
70962328|NCT01699789|141429184|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio (RR)|0.49|||||TWO_SIDED|95.0|0.3|0.82||||||Adjusted analyses used multiply imputed data (N=553), weighted for eligible sample for enrollment; Poisson regression model adjusted for baseline and covariates and accounted for the design effect of the cluster randomization.||0.82|0.30|
70962329|NCT01699789|141429185|SUPERIORITY||Rate Ratio (RR)|2.84|||||TWO_SIDED|95.0|1.39|5.8||||||Adjusted analyses used multiply imputed data (N=588), weighted for eligible sample for enrollment; Poisson regression model adjusted for baseline status of the dependent variable and covariates and accounted for the design effect of the cluster randomization.||5.80|1.39|
70962330|NCT01699789|141429186|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio (RR)|6.2|||||TWO_SIDED|95.0|1.5|24.9||||||Adjusted analyses used multiply imputed data (N=410), weighted for eligible sample for enrollment; Poisson regression model adjusted for baseline and covariates and accounted for the design effect of the cluster randomization.||24.9|1.5|
70881291|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.2||||0.2353|TWO_SIDED|80.0|-1.72|6.12|||Mixed Models Analysis|||Change from baseline at Day 337||6.12|-1.72|0.2353
70881292|NCT02515942|141247222|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.36||||0.5471|TWO_SIDED|80.0|-4.24|3.53|||Mixed Models Analysis|||Change from baseline at Day 337||3.53|-4.24|0.5471
70881293|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.74||||0.0913|TWO_SIDED|80.0|-5.38|-0.11|||Mixed Models Analysis|||Change from baseline at Day 2||-0.11|-5.38|0.0913
70881294|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.28||||0.4454|TWO_SIDED|80.0|-2.89|2.33|||Mixed Models Analysis|||Change from baseline at Day 2||2.33|-2.89|0.4454
70962331|NCT01699789|141429187|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.59|1.57||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.57|0.59|
70881295|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.46||||0.8861|TWO_SIDED|80.0|-0.16|5.08|||Mixed Models Analysis|||Change from baseline at Day 2||5.08|-0.16|0.8861
70962332|NCT01699789|141429188|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.4|1.22|||||When analyzed as change from baseline, CEP showed significant reductions in likelihood of behavioral health hospitalizations at 6 months (P \< 0.01) and 12 months (P \< 0.01).|Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a generalized estimating equation logistic regression model adjusted for covariates, accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.22|.40|
70962333|NCT01699789|141429189|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.66|1.66||||||Intent-to-treat analyses of repeated measures were developed including all participants with data at baseline, 6-month, or 12-month. Missing data were imputed. A generalized estimating equation (GEE) with a logit link function was used with adjustment for covariates.||1.66|.66|
70962334|NCT01699789|141429190|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.74|1.42||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a generalized estimating equation logistic regression model adjusted for covariates, accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.42|0.74|
70962335|NCT01699789|141429191|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.6|1.05||||||Intent-to-treat analyses of repeated measures were developed including all participants with data at baseline, 6-month, or 12-month. Missing data were imputed. A generalized estimating equation (GEE) with a logit link function was used with adjustment for covariates.||1.05|.60|
70962336|NCT01699789|141429192|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.72|1.32||||||Intent-to-treat analyses of repeated measures were developed including all participants with data at baseline, 6-month, or 12-month. Missing data were imputed. A generalized estimating equation (GEE) with a logit link function was used with adjustment for covariates.||1.32|0.72|
70962337|NCT01699789|141429193|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.55|1.39||||||Intent-to-treat analyses of repeated measures were developed including all participants with data at baseline, 6-month, or 12-month. Missing data were imputed. A generalized estimating equation (GEE) with a logit link function was used with adjustment for covariates.||1.39|0.55|
70962338|NCT01699789|141429194|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.65|1.29||||||Intent-to-treat analyses of repeated measures were developed including all participants with data at baseline, 6-month, or 12-month. Missing data were imputed. A generalized estimating equation (GEE) with a log link function was used with adjustment for covariates.||1.29|0.65|
70881296|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.16||||0.713|TWO_SIDED|80.0|-1.49|3.8|||Mixed Models Analysis|||Change from baseline at Day 29||3.80|-1.49|0.7130
70881297|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.37||||0.8759|TWO_SIDED|80.0|-0.26|5.01|||Mixed Models Analysis|||Change from baseline at Day 29||5.01|-0.26|0.8759
70962339|NCT01699789|141429195|SUPERIORITY||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|0.2|2.0||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a linear regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.0|0.2|
70881298|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.22||||0.7256|TWO_SIDED|80.0|-1.39|3.82|||Mixed Models Analysis|||Change from baseline at Day 29||3.82|-1.39|0.7256
70962340|NCT01699789|141429196|SUPERIORITY||Rate Ratio (RR)|0.2|||||TWO_SIDED|95.0|0.1|0.8||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||0.8|0.1|
70962341|NCT01699789|141429197|SUPERIORITY||Rate Ratio (RR)|1.2|||||TWO_SIDED|95.0|0.4|3.7||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||3.7|0.4|
70962342|NCT01699789|141429198|SUPERIORITY||Rate Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.8|1.5||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.5|0.8|
70962343|NCT01699789|141429199|SUPERIORITY||Rate Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.5|2.1||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.1|0.5|
70881299|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.17||||0.3111|TWO_SIDED|80.0|-4.22|1.88|||Mixed Models Analysis|||Change from baseline at Day 57||1.88|-4.22|0.3111
70881300|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.7||||0.236|TWO_SIDED|80.0|-4.73|1.34|||Mixed Models Analysis|||Change from baseline at Day 57||1.34|-4.73|0.2360
70962344|NCT01699789|141429200|SUPERIORITY||Rate Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.7|1.6||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.6|0.7|
70962345|NCT01699789|141429201|SUPERIORITY||Rate Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.3|4.0||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||4.0|0.3|
70962346|NCT01699789|141429202|SUPERIORITY||Rate Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.4|2.7||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.7|0.4|
70962347|NCT01699789|141429203|SUPERIORITY||Rate Ratio (RR)|1.4|||||TWO_SIDED|95.0|0.2|8.6||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||8.6|0.2|
70962348|NCT01699789|141429204|SUPERIORITY||Rate Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.4|1.8||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.8|0.4|
70962349|NCT01699789|141429205|SUPERIORITY||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|1.2|2.6||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.6|1.2|
70962350|NCT01699789|141429206|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.5|1.5||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.5|0.5|
70881301|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.53||||0.411|TWO_SIDED|80.0|-3.55|2.49|||Mixed Models Analysis|||Change from baseline at Day 57||2.49|-3.55|0.4110
70881302|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.13||||0.5247|TWO_SIDED|80.0|-2.57|2.83|||Mixed Models Analysis|||Change from baseline at Day 85||2.83|-2.57|0.5247
70962351|NCT01699789|141429207|SUPERIORITY||Odds Ratio (OR)|2.9|||||TWO_SIDED|95.0|1.0|8.3||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||8.3|1.0|
70962352|NCT01699789|141429208|SUPERIORITY||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.7|1.7||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.7|0.7|
70962353|NCT01699789|141429209|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.5|2.0||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.0|0.5|
70881303|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.37||||0.0534|TWO_SIDED|80.0|-6.04|-0.7|||Mixed Models Analysis|||Change from baseline at Day 85||-0.70|-6.04|0.0534
70881304|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.5||||0.0475|TWO_SIDED|80.0|-6.18|-0.82|||Mixed Models Analysis|||Change from baseline at Day 85||-0.82|-6.18|0.0475
70881305|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.92||||0.0575|TWO_SIDED|80.0|-7.11|-0.74|||Mixed Models Analysis|||Change from baseline at Day 113||-0.74|-7.11|0.0575
70881306|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.16||||0.1876|TWO_SIDED|80.0|-5.29|0.97|||Mixed Models Analysis|||Change from baseline at Day 113||0.97|-5.29|0.1876
70962354|NCT01699789|141429210|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|1.0|2.0||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.0|1.0|
70962355|NCT01699789|141429211|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.6|1.7||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.7|0.6|
70962356|NCT01699789|141429212|SUPERIORITY||Cox Proportional Hazard|1.12|||>|0.05|TWO_SIDED|95.0|0.83|1.5|||Regression, Cox|||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Cox proportional-hazards model adjusted for baseline covariates. Data were multiply imputed and weighted for eligible sample for enrollment, accounted for the design effect of the cluster randomization.||1.50|0.83|>.05
70962357|NCT01699789|141429213|SUPERIORITY||Cox Proportional Hazard|1.23|||>|0.05|TWO_SIDED|95.0|0.99|1.52|||Regression, Cox|||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Cox proportional-hazards model adjusted for baseline covariates. Data were multiply imputed and weighted for eligible sample for enrollment, accounted for the design effect of the cluster randomization.||1.52|0.99|>0.05
70962358|NCT01699789|141429214|SUPERIORITY||Odds Ratio (OR)|1.73|||||TWO_SIDED|95.0|1.0|2.99||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline covariates. Data were multiply imputed and weighted for eligible sample for enrollment, accounted for the design effect of the cluster randomization.||2.99|1.00|
70962359|NCT01699789|141429215|SUPERIORITY||Odds Ratio (OR)|2.62|||||TWO_SIDED|95.0|1.24|5.54||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline covariates. Data were multiply imputed and weighted for eligible sample for enrollment, accounted for the design effect of the cluster randomization.||5.54|1.24|
70962360|NCT02411578|141429226|SUPERIORITY|||||||0.99||||||Proportions of successes in each arm were compared using a generalized linear mixed model with a logistic link function, random participant effect to account for correlated data from some pts having multiple events, and adjustment for baseline BG.|Mixed Models Analysis|||For the crossover trial primary analysis, analyzed events were study treatment events meeting the following criteria: a) a survey was completed in the smart phone application, b) the initial BG measurement was 40 to 69 mg/dL, c) BG measurements were performed at both the 15-minute (in a window of 13 to 20 minutes) and 30-minute (28 to 40 minutes) time points, and d) appropriate treatment including dose was taken both at the initial and 15-minute time points.||||0.99
70962361|NCT02411578|141429227|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.34
70962362|NCT02411578|141429228|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.01
70962363|NCT02411578|141429229|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.02
70962364|NCT02411578|141429230|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.86
70962365|NCT02411578|141429231|SUPERIORITY|||||||0.95|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.95
70962366|NCT02411578|141429232|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.78
70962367|NCT02411578|141429233|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.21
70962368|NCT02411578|141429234|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.09
70962369|NCT02411578|141429235|SUPERIORITY|||||||0.49|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.49
70962370|NCT02411578|141429236|SUPERIORITY|||||||0.63|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.63
70962371|NCT02411578|141429237|SUPERIORITY|||||||0.41|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.41
70962372|NCT02411578|141429238|SUPERIORITY|||||||0.8|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.80
70962373|NCT02411578|141429239|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.13
70962374|NCT02411578|141429240|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.70
70962375|NCT02411578|141429241|SUPERIORITY|||||||0.93||||||Proportions of successes in each arm were compared using a generalized linear mixed model with a logistic link function, random participant effect to account for correlated data from some pts having multiple events, and adjustment for baseline BG.|Mixed Models Analysis|||||||0.93
70962376|NCT02411578|141429242|SUPERIORITY|||||||0.66||||||Proportions of successes in each arm were compared using a generalized linear mixed model with a logistic link function, random participant effect to account for correlated data from some pts having multiple events, and adjustment for baseline BG.|Mixed Models Analysis|||||||0.66
70962377|NCT02411578|141429243|SUPERIORITY|||||||0.08||||||Proportions of successes in each arm were compared using a generalized linear mixed model with a logistic link function, random participant effect to account for correlated data from some pts having multiple events, and adjustment for baseline BG.|Mixed Models Analysis|||||||0.08
70962378|NCT01557348|141429244|SUPERIORITY_OR_OTHER|||||||0.0068||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||||||0.0068
70962379|NCT01557348|141429245|SUPERIORITY_OR_OTHER|||||||0.0588||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||||||0.0588
70962380|NCT01557348|141429246|SUPERIORITY_OR_OTHER|||||||0.1126||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in TJC at Month 6||||0.1126
70962381|NCT01557348|141429246|SUPERIORITY_OR_OTHER|||||||0.2342||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in TJC at Month 12||||0.2342
70962382|NCT01557348|141429247|SUPERIORITY_OR_OTHER|||||||0.4168||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in SJC at Month 6||||0.4168
70962383|NCT01557348|141429247|SUPERIORITY_OR_OTHER|||||||0.5867||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in SJC at Month 12||||0.5867
70962384|NCT01557348|141429248|SUPERIORITY_OR_OTHER|||||||0.8758||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in CRP at Month 6||||0.8758
70962385|NCT01557348|141429248|SUPERIORITY_OR_OTHER|||||||0.4849||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in CRP at Month 12||||0.4849
70962386|NCT01557348|141429249|SUPERIORITY_OR_OTHER|||||||0.0086||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in ESR at Month 6||||0.0086
70962387|NCT01557348|141429249|SUPERIORITY_OR_OTHER|||||||0.2918||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in ESR at Month 12||||0.2918
70962388|NCT01557348|141429250|SUPERIORITY_OR_OTHER|||||||0.0764||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Physician Global Assessment of Disease at Month 6||||0.0764
70962389|NCT01557348|141429250|SUPERIORITY_OR_OTHER|||||||0.0587||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Physician Global Assessment of Disease at Month 12||||0.0587
70962390|NCT01557348|141429251|SUPERIORITY_OR_OTHER|||||||0.0443||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Patient Global Assessment of Disease at Month 6||||0.0443
70962391|NCT01557348|141429251|SUPERIORITY_OR_OTHER|||||||0.4802||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Patient Global Assessment of Disease at Month 12||||0.4802
70962392|NCT01557348|141429252|SUPERIORITY_OR_OTHER|||||||0.2026||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Participant's Visual Analogue Scale Pain Score at Months 6||||0.2026
70962393|NCT01557348|141429252|SUPERIORITY_OR_OTHER|||||||0.0295||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Participant's Visual Analogue Scale Pain Score at Months 12||||0.0295
70962394|NCT01557348|141429253|SUPERIORITY_OR_OTHER|||||||0.337||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in HAQ-DI at Month 6||||0.3370
70962395|NCT01557348|141429253|SUPERIORITY_OR_OTHER|||||||0.1515||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in HAQ-DI at Month 12||||0.1515
70962396|NCT01557348|141429254|SUPERIORITY_OR_OTHER|||||||0.3253||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in duration of morning stiffness at month 6||||0.3253
70962397|NCT01557348|141429254|SUPERIORITY_OR_OTHER|||||||0.3535||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in duration of morning stiffness at month 12||||0.3535
70962398|NCT04484259|141429284|NON_INFERIORITY|non-inferiority margin 45 PRU|Mean Difference (Final Values)|7.0|||||TWO_SIDED|95.0|-23.0|38.0||||||The primary end point was non-inferiority of Ticagrelor 60 mg monotherapy vs. aspirin plus Ticagrelor 60 mg||38|-23|
70962399|NCT03645954|141429308|SUPERIORITY||||||<|0.01||||||The threshold for statistical significance was p = 0.05.|Chi-squared|||||||<0.01
70962400|NCT03645954|141429309|SUPERIORITY||||||>|0.05||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||>0.05
70962401|NCT03645954|141429310|OTHER||||||>|0.05||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||>0.05
70962402|NCT03645954|141429311|OTHER||||||>|0.05||||||The threshold for statistical significance was p = 0.05.|Chi-squared|||||||>0.05
70962403|NCT03645954|141429312|OTHER||||||>|0.05||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||>0.05
70962404|NCT03645954|141429313|OTHER||||||>|0.05||||||The threshold for statistical significance was p = 0.05.|Chi-squared|||||||>0.05
70962405|NCT02445196|141429359|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.57||||0.035|TWO_SIDED||||||ANOVA|||Repeated measures ANOVAs assessed the condition by time (baseline to posttreatment) interaction effects covarying PTSD treatment. Following the ITT principle, data from all randomized participants were analyzed and multiple imputation replaced missing values. A power analysis indicated that to achieve 80% power to detect an effect size in the magnitude (i.e., d = 0.25 to .33) with alpha of .05 and a correlation between repeated measures of .5, 60 participants per condition would be needed.||||.035
70962406|NCT02445196|141429360|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.87||||0.086|TWO_SIDED||||||ANOVA|||||||.086
70962407|NCT02445196|141429361|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.75||||0.007|TWO_SIDED||||||ANOVA|||||||.007
70962408|NCT02445196|141429362|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.72||||0.005|TWO_SIDED||||||ANOVA|||||||.005
70881307|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.76||||0.7644|TWO_SIDED|80.0|-1.38|4.91|||Mixed Models Analysis|||Change from baseline at Day 113||4.91|-1.38|0.7644
70962409|NCT02445196|141429363|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.78||||0.113|TWO_SIDED||||||t-test, 2 sided|||||||.113
70962410|NCT02072434|141429431|OTHER||Odds Ratio (OR)|0.46|||||TWO_SIDED|95.0|0.12|1.43||||||||1.43|0.12|
70962411|NCT02072434|141429432|OTHER||Odds Ratio (OR)|1.48|||||TWO_SIDED|95.0|0.64|3.55||||||||3.55|0.64|
70962412|NCT02072434|141429433|OTHER||Difference between percentages|-0.72|||||TWO_SIDED|95.0|-1.59|0.15||||||||0.15|-1.59|
70962413|NCT02525861|141429442|OTHER||Geometric Mean Ratio|5.398|||<|0.001|||||||Mixed-effects model|||Statistical analysis was collected and assessed based on A1P1 Levels at baseline and On-treatment BAL visit.||||<0.001
70962414|NCT02525861|141429443|OTHER||Geometric Mean Ratio|2.259|||<|0.001|||||||mixed-effects model|||Statistical analysis was collected and assessed based on functional A1P1 Levels at baseline and On-treatment BAL visit.||||<0.001
70962415|NCT01117454|141429450|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank with continuity correction||||||0.008
70962416|NCT01681628|141429452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.9|STANDARD_ERROR_OF_MEAN|2.0|<|0.001|TWO_SIDED|95.0|16.1|24.0||This was an a priori threshold.|t-test, 2 sided|||Means and differences were calculated for both groups before (time 1) and after treatment (or no treatment) (time 2). Also, the differences in mean scores from time 1 to 2 were compared between the two groups, the primary outcome. The numbers in the groups were considered adequate based on previous similar studies. The null hypothesis was that there would be no difference in any mean change in scores from time 1 to 2, between both groups.||24.0|16.1|<0.001
70962417|NCT01681628|141429452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.4|STANDARD_DEVIATION|14.7|<|0.001|TWO_SIDED|95.0|29.1|34.7|||t-test, 2 sided|||Change in PCL-C scores from before to after treatment.||34.7|29.1|<0.001
70962418|NCT01681628|141429452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.4|STANDARD_DEVIATION|14.2|<|0.001|TWO_SIDED|95.0|11.4|17.1|||t-test, 2 sided|||Changes in PCL-C scores for control group after no treatment.||17.1|11.4|<0.001
70962419|NCT01681628|141429452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.6|STANDARD_DEVIATION|13.5|<|0.001|TWO_SIDED|95.0|17.1|22.5|||t-test, 2 sided|Degrees of freedom 94||Change in control group PCL-C scores after treatment, that is from time 2 to time 3.||22.5|17.1|<0.001
70962420|NCT01681628|141429453|SUPERIORITY_OR_OTHER||percentage of participants|65.7|||<|0.001|TWO_SIDED||||||Chi-squared|||Chi-squared test of any change in PCL-C from time 1 to time 2.||||<0.001
70962421|NCT01681628|141429453|SUPERIORITY_OR_OTHER||% of participants with PCL score > 50|41.0|||<|0.001|TWO_SIDED||||||Chi-squared|||Comparison of the percentage with diagnostic scores in the wait list group after no treatment at times 1 and 2.||||<0.001
70962422|NCT01681628|141429453|SUPERIORITY_OR_OTHER||Percentage|39.9|||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
70962423|NCT01681628|141429454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.8|||<|0.001|TWO_SIDED|95.0|15.2|20.5|||t-test, 2 sided|||Both the original treatment and control groups were combined as both groups had been treated at a similar time before the nineteen month assessment. The null hypothesis was that there had been no change in the PCL-C scores at nineteen months compared to one week following treatment.||20.5|15.2|<0.001
70881308|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.85||||0.0838|TWO_SIDED|80.0|-7.42|-0.28|||Mixed Models Analysis|||Change from baseline at Day 141||-0.28|-7.42|0.0838
70881309|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.38||||0.4444|TWO_SIDED|80.0|-3.89|3.13|||Mixed Models Analysis|||Change from baseline at Day 141||3.13|-3.89|0.4444
70881310|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.47||||0.8977|TWO_SIDED|80.0|-0.04|6.97|||Mixed Models Analysis|||Change from baseline at Day 141||6.97|-0.04|0.8977
70881311|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.05||||0.4917|TWO_SIDED|80.0|-2.92|2.82|||Mixed Models Analysis|||Change from baseline at Day 169||2.82|-2.92|0.4917
70881312|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.05||||0.4909|TWO_SIDED|80.0|-2.89|2.79|||Mixed Models Analysis|||Change from baseline at Day 169||2.79|-2.89|0.4909
70881313|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.0||||0.4992|TWO_SIDED|80.0|-2.82|2.81|||Mixed Models Analysis|||Change from baseline at Day 169||2.81|-2.82|0.4992
70881314|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.09||||0.3285|TWO_SIDED|80.0|-4.25|2.07|||Mixed Models Analysis|||Change from baseline at Day 197||2.07|-4.25|0.3285
70962424|NCT04796896|141429476|NON_INFERIORITY|"The noninferiority of GM value (based on GLSM) was considered demonstrated if:~The lower bound of the 95% confidence interval (CI) of the geometric mean ratio (GMR) was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold)."|GMR|1.224|||||TWO_SIDED|95.0|1.061|1.413||||||||1.413|1.061|
70881315|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.45||||0.1568|TWO_SIDED|80.0|-5.57|0.67|||Mixed Models Analysis|||Change from baseline at Day 197||0.67|-5.57|0.1568
70881316|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.36||||0.2867|TWO_SIDED|80.0|-4.46|1.74|||Mixed Models Analysis|||Change from baseline at Day 197||1.74|-4.46|0.2867
70881317|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.93||||0.0798|TWO_SIDED|80.0|-7.51|-0.35|||Mixed Models Analysis|||Change from baseline at Day 225||-0.35|-7.51|0.0798
70962425|NCT04796896|141429477|NON_INFERIORITY|"The noninferiority of GM value (based on GLSM) was considered demonstrated if the following were true:~The lower bound of the 95% CI of the GMR was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold)."|GMR|0.995|||||TWO_SIDED|95.0|0.87|1.139||||||||1.139|0.870|
70962426|NCT04796896|141429477|NON_INFERIORITY|"The noninferiority of GM value (based on GLSM) was considered demonstrated if the following were true:~The lower bound of the 95% CI of the GMR was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold)."|GMR|1.257|||||TWO_SIDED|95.0|1.101|1.434||||||||1.434|1.101|
70962427|NCT04796896|141429478|NON_INFERIORITY|The noninferiority of the SRR was considered demonstrated if the following were true: The lower bound of the 95% CI of the SRR difference was \>-10% based on the noninferiority margin of 10% and the SRR difference point estimate was ≥-5% (minimum threshold).|percentage difference|-0.3|||||TWO_SIDED|95.0|-2.2|1.6||||||||1.6|-2.2|
70962428|NCT04796896|141429479|NON_INFERIORITY|The noninferiority of the SRR was considered demonstrated if the following were true: The lower bound of the 95% CI of the SRR difference was \>-10% based on the noninferiority margin of 10% and the SRR difference point estimate was ≥-5% (minimum threshold).|percentage difference|-0.4|||||TWO_SIDED|95.0|-2.5|1.5||||||||1.5|-2.5|
70962429|NCT04796896|141429479|NON_INFERIORITY|The noninferiority of the SRR was considered demonstrated if the following were true: The lower bound of the 95% CI of the SRR difference was \>-10% based on the noninferiority margin of 10% and the SRR difference point estimate was ≥-5% (minimum threshold).|percentage difference|0.7|||||TWO_SIDED|95.0|-0.8|2.4||||||||2.4|-0.8|
70962430|NCT04796896|141429480|NON_INFERIORITY|"The noninferiority of GM value (based on GLSM) was considered demonstrated if the following were true:~The lower bound of the 95% CI of the GMR was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold)."|GMR|3.897|||||TWO_SIDED|95.0|3.158|4.808||||||||4.808|3.158|
70962431|NCT04796896|141429480|NON_INFERIORITY|"The noninferiority of GM value (based on GLSM) was considered demonstrated if the following were true:~The lower bound of the 95% CI of the GMR was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold)."|GMR|3.982|||||TWO_SIDED|95.0|3.404|4.657||||||||4.657|3.404|
70962432|NCT04796896|141429482|NON_INFERIORITY|The noninferiority of the SRR was considered demonstrated if the following were true: The lower bound of the 95% CI of the SRR difference was \>-10% based on the noninferiority margin of 10% and the SRR difference point estimate was ≥-5% (minimum threshold).|percentage difference|0.7|||||TWO_SIDED|95.0|-4.4|2.4||||||||2.4|-4.4|
70962433|NCT04796896|141429482|NON_INFERIORITY|The noninferiority of the SRR was considered demonstrated if the following were true: The lower bound of the 95% CI of the SRR difference was \>-10% based on the noninferiority margin of 10% and the SRR difference point estimate was ≥-5% (minimum threshold).|percentage difference|0.7|||||TWO_SIDED|95.0|-2.2|2.4||||||||2.4|-2.2|
70962434|NCT04796896|141429491|OTHER|The 95% confidence interval (CI) of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.706|||||TWO_SIDED|95.0|0.325|0.873|||||Vaccine efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.873|0.325|
70962435|NCT04796896|141429491|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.409|||||TWO_SIDED|95.0|0.287|0.509|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.509|0.287|
70962436|NCT04796896|141429491|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.324|||||TWO_SIDED|95.0|0.127|0.474|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.474|0.127|
70962437|NCT04796896|141429492|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.683|||||TWO_SIDED|95.0|0.151|0.882|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.882|0.151|
70962438|NCT04796896|141429492|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.281|||||TWO_SIDED|95.0|-0.007|0.48|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.480|-0.007|
70881318|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.47||||0.2962|TWO_SIDED|80.0|-5.0|2.06|||Mixed Models Analysis|||Change from baseline at Day 225||2.06|-5.00|0.2962
70881319|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.46||||0.8163|TWO_SIDED|80.0|-1.05|5.98|||Mixed Models Analysis|||Change from baseline at Day 225||5.98|-1.05|0.8163
70881320|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.64||||0.0708|TWO_SIDED|80.0|-6.81|-0.47|||Mixed Models Analysis|||Change from baseline at Day 253||-0.47|-6.81|0.0708
70881321|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.46||||0.575|TWO_SIDED|80.0|-2.67|3.59|||Mixed Models Analysis|||Change from baseline at Day 253||3.59|-2.67|0.5750
70881322|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|4.1||||0.956|TWO_SIDED|80.0|1.03|7.17|||Mixed Models Analysis|||Change from baseline at Day 253||7.17|1.03|0.9560
70881323|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.22||||0.1283|TWO_SIDED|80.0|-6.86|0.42|||Mixed Models Analysis|||Change from baseline at Day 281||0.42|-6.86|0.1283
70962439|NCT04796896|141429492|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|-0.068|||||TWO_SIDED|95.0|-0.832|0.352|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.352|-0.832|
70962440|NCT04796896|141429493|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.76|||||TWO_SIDED|95.0|-0.416|0.965|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.965|-0.416|
70962441|NCT04796896|141429493|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.466|||||TWO_SIDED|95.0|0.328|0.574|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.574|0.328|
70962442|NCT04796896|141429493|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.432|||||TWO_SIDED|95.0|0.232|0.576|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.576|0.232|
70962443|NCT02175004|141429511|SUPERIORITY||Least Squares Mean Difference|-17.84|||<|0.001|TWO_SIDED|95.0|-26.12|-9.56||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS+7 Composite Score at Week 78||-9.56|-26.12|<0.001
70962444|NCT02175004|141429511|SUPERIORITY||Least Squares Mean Difference|-20.11|||<|0.001|TWO_SIDED|95.0|-31.27|-8.95||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS+7 Composite Score at Week 156||-8.95|-31.27|<0.001
70962445|NCT02175004|141429512|SUPERIORITY||Least Squares Mean Difference|-0.06||||0.638|TWO_SIDED|95.0|-0.32|0.2||P-value=MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Heart Rate to Deep Breathing Score at Week 78||0.20|-0.32|0.638
70962446|NCT02175004|141429512|SUPERIORITY||Least Squares Mean Difference|-0.01||||0.965|TWO_SIDED|95.0|-0.3|0.29||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Heart Rate to Deep Breathing Score at Week 156||0.29|-0.30|0.965
70962447|NCT02175004|141429513|SUPERIORITY||Least Squares Mean Difference|-1.09|||<|0.001|TWO_SIDED|95.0|-1.68|-0.5||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Nerve Conduction Score at Week 78||-0.50|-1.68|<0.001
70962448|NCT02175004|141429513|SUPERIORITY||Least Squares Mean Difference|-0.66||||0.067|TWO_SIDED|95.0|-1.38|0.05||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Nerve Conduction Score at Week 156||0.05|-1.38|0.067
70962449|NCT02175004|141429514|SUPERIORITY||Least Squares Mean Difference|0.34||||0.821|TWO_SIDED|95.0|-2.67|3.36||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Heat-Pain Sensory Score at Week 78||3.36|-2.67|0.821
70962450|NCT02175004|141429514|SUPERIORITY||Least Squares Mean Difference|-2.16||||0.293|TWO_SIDED|95.0|-6.21|1.9||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Heat-Pain Sensory Score at Week 156||1.90|-6.21|0.293
70962451|NCT02175004|141429515|SUPERIORITY||Least Squares Mean Difference|-2.78||||0.047|TWO_SIDED|95.0|-5.53|-0.03||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Touch-Pressure Sensory Score at Week 78||-0.03|-5.53|0.047
70962452|NCT02175004|141429515|SUPERIORITY||Least Squares Mean Difference|-3.07||||0.041|TWO_SIDED|95.0|-6.0|-0.13||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Touch-Pressure Sensory Score at Week 156||-0.13|-6.00|0.041
70962453|NCT02175004|141429516|OTHER||Least Squares Mean Difference|-17.48|||<|0.001|TWO_SIDED|95.0|-26.92|-8.03||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the NIS Composite Score at Week 52 of Year 4||-8.03|-26.92|<0.001
70962454|NCT02175004|141429517|SUPERIORITY||Least Squares Mean Difference|-0.01||||0.941|TWO_SIDED|95.0|-0.19|0.17||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change from Baseline in the NIS Component: Cranial Nerves Score Score at Week 52 of Year 4||0.17|-0.19|0.941
70962455|NCT02175004|141429518|SUPERIORITY||Least Squares Mean Difference|-9.56||||0.011|TWO_SIDED|95.0|-16.97|-2.16||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change from Baseline in the NIS Component: Muscle Weakness Score at Week 52 of Years 4||-2.16|-16.97|0.011
70962456|NCT02175004|141429519|SUPERIORITY||Least Squares Mean Difference|-1.05||||0.356|TWO_SIDED|95.0|-3.28|1.18||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change from Baseline in the NIS Component: Reflexes Score at Week 52 of Years 4||1.18|-3.28|0.356
70962457|NCT02175004|141429520|SUPERIORITY||Least Squares Mean Difference|-5.38|||<|0.001|TWO_SIDED|95.0|-8.58|-2.19||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change from Baseline in the NIS Component: Sensory Score at Week 52 of Years 4||-2.19|-8.58|<0.001
70962458|NCT02175004|141429521|SUPERIORITY||Least Squares Mean Difference|-9.31||||0.026|TWO_SIDED|95.0|-17.48|-1.14||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the Norfolk QOL-DN Questionnaire Total Score at Week 78||-1.14|-17.48|0.026
70962459|NCT02175004|141429521|SUPERIORITY||Least Squares Mean Difference|-7.4||||0.107|TWO_SIDED|95.0|-16.41|1.62||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the Norfolk QOL-DN Questionnaire Total Score at Week 156||1.62|-16.41|0.107
70962460|NCT02175004|141429521|SUPERIORITY||Least Squares Mean Difference|-2.72||||0.669|TWO_SIDED|95.0|-15.22|9.77||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the Norfolk QOL-DN Questionnaire Total Score at Week 52 of Year 4||9.77|-15.22|0.669
70962461|NCT02175004|141429522|SUPERIORITY||Least Squares Mean Difference|-6.3||||0.097|TWO_SIDED|95.0|-13.75|1.15||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the Norfolk QOL-DN Change From CS2 Baseline in the Norfolk QOL-DN Questionnaire Total Score at Week 78||1.15|-13.75|0.097
70962462|NCT02175004|141429522|SUPERIORITY||Least Squares Mean Difference|-8.89||||0.081|TWO_SIDED|95.0|-18.88|1.11||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change from Baseline in the Norfolk QoL-DN Physical Functioning/Large Fiber Neuropathy Domain Score at Week 156||1.11|-18.88|0.081
70962463|NCT02175004|141429522|SUPERIORITY||Least Squares Mean Difference|-11.87||||0.171|TWO_SIDED|95.0|-28.89|5.16||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the Norfolk QOL-DN Physical Functioning/Large Fiber Neuropathy Domain Score at Week 52 of Year 4||5.16|-28.89|0.171
70962464|NCT01383161|141429531|SUPERIORITY|||||||0.5|||||||mixed-effects general linear model|||||||0.5
70962465|NCT01383161|141429531|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
70962466|NCT01383161|141429531|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.2
70962467|NCT01383161|141429532|SUPERIORITY|||||||0.08|||||||mixed-effects general linear model|||||||0.08
70962468|NCT01383161|141429532|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||.006
70962469|NCT01383161|141429532|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
70962470|NCT01383161|141429533|SUPERIORITY|||||||0.05|||||||mixed-effects general linear model|||||||0.05
70962471|NCT01383161|141429533|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||0.002
70962472|NCT01383161|141429533|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
70962473|NCT01383161|141429534|SUPERIORITY|||||||0.08|||||||mixed-effects general linear model|||||||0.08
70962474|NCT01383161|141429534|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||.002
70962475|NCT01383161|141429534|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.5
70962476|NCT01383161|141429535|SUPERIORITY|||||||0.04|||||||mixed-effects general linear model|||||||0.04
70962477|NCT01383161|141429535|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
70962478|NCT01383161|141429535|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
70962479|NCT01383161|141429536|SUPERIORITY|||||||0.3|||||||mixed-effects general linear model|||||||0.3
70962480|NCT01383161|141429536|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
70962481|NCT01383161|141429536|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.6
70962482|NCT00819286|141429557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.003|TWO_SIDED|95.0|||||t-test, 2 sided|||3 Month CT Scores (Plates vs Wires)||||0.003
70962483|NCT00819286|141429557|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||6 Month CT Scores (Plates vs Wires)||||0.01
70962484|NCT00819286|141429558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.93||95.0|||||t-test, 1 sided|||Plates vs Wires||||0.93
70962485|NCT03153137|141429587|SUPERIORITY|For each stage, the p-value from the ANCOVA model including randomized treatment, geographical region, and baseline peak VO2 was used to construct the final adjusted p-value.|Median unbiased estimate and repeated CI|0.62|||=|0.193|TWO_SIDED|99.0|-0.62|1.85||Final adjusted p-value (from weighted inverse normal combination test)|ANCOVA|||Due to adaptive nature of the design, the main analysis was conducted on FAS using the inverse normal combination method with pre-specified weights to combine first and second stage p-values.||1.85|-0.62|= 0.1930
70962486|NCT01372410|141429625|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Day 8 analysis.|Wald Test|||||||<0.0001
70962487|NCT01372410|141429625|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Pooled Day 7 and 8 analysis.|Wald Test|||||||<0.0001
70962488|NCT01372410|141429626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|||<|0.001|TWO_SIDED|95.0|0.058|0.168|||Mixed Models Analysis|||||0.168|0.058|<0.001
70962489|NCT01372410|141429626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|||<|0.001|TWO_SIDED|95.0|0.045|0.158|||Mixed Models Analysis|||||0.158|0.045|<0.001
70962490|NCT01372410|141429626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.124|||<|0.001|TWO_SIDED|95.0|0.068|0.179|||Mixed Models Analysis|||||0.179|0.068|<0.001
70962491|NCT01372410|141429626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|||<|0.001|TWO_SIDED|95.0|0.127|0.239|||Mixed Models Analysis|||||0.239|0.127|<0.001
70962492|NCT01372410|141429626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|||<|0.001|TWO_SIDED|95.0|0.069|0.182|||Mixed Models Analysis|||||0.182|0.069|<0.001
70962493|NCT01372410|141429626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.139|||<|0.001|TWO_SIDED|95.0|0.083|0.196|||Mixed Models Analysis|||||0.196|0.083|<0.001
70962494|NCT01372410|141429626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|||<|0.001|TWO_SIDED|95.0|0.045|0.157|||Mixed Models Analysis|||||0.157|0.045|<0.001
70962495|NCT01067326|141429661|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||Change in EPCs from baseline to 4 months||||0.02
70962496|NCT01067326|141429662|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||t-test, 2 sided|||Difference in systolic blood pressure from baseline to 4 months.||||.006
70962497|NCT01067326|141429663|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||t-test, 2 sided|||Difference in diastolic blood pressure from baseline to 4 months.||||0.04
70962498|NCT01067326|141429664|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||t-test, 2 sided|||P-value for intergroup comparison of change from baseline to month 4||||0.94
70962499|NCT00696761|141429665|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
70962500|NCT00696761|141429666|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Kruskal-Wallis|||The Kruskal-Wallis test, analysis of variance, and the Wilcoxon signed rank-sum test were used to compare changes from baseline to endpoint after treatment.||||<0.05
70962501|NCT01603082|141429693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-159.1|STANDARD_ERROR_OF_MEAN|17.9|<|0.001|TWO_SIDED|95.0|-194.7|-123.5|||t-test, 2 sided||Ticagrelor minus clopidogrel.|||-123.5|-194.7|<0.001
70962502|NCT01603082|141429694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.4|STANDARD_ERROR_OF_MEAN|15.2||0.182|TWO_SIDED|95.0|-50.5|9.7|||t-test, 2 sided||Ticagrelor minus clopidogrel.|Analysis at 0.5 hours after the loading dose||9.7|-50.5|0.182
70962503|NCT01603082|141429694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-158.5|STANDARD_ERROR_OF_MEAN|15.5|<|0.001|TWO_SIDED|95.0|-189.4|-127.7|||t-test, 2 sided||Ticagrelor minus clopidogrel.|Analysis at 8 hours after the loading dose.||-127.7|-189.4|<0.001
70962504|NCT01603082|141429694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.6|STANDARD_ERROR_OF_MEAN|16.5||0.01|TWO_SIDED|95.0|-76.5|-10.7|||t-test, 2 sided||Ticagrelor minus clopidogrel.|Analysis at end of PCI.||-10.7|-76.5|0.010
70962505|NCT00852592|141429695|SUPERIORITY_OR_OTHER||||||=|0.005|||||||ANOVA|||||||=0.005
70962506|NCT00852592|141429696|SUPERIORITY_OR_OTHER||||||=|0.004|||||||ANOVA|||||||=0.004
70962507|NCT02979925|141429700|SUPERIORITY|||||||0.246|||||||Mixed Models Analysis|||||||0.246
70962508|NCT02979925|141429701|SUPERIORITY|||||||0.651|||||||Mixed Models Analysis|||||||0.651
70962509|NCT02979925|141429702|SUPERIORITY|||||||0.902|||||||Mixed Models Analysis|||||||0.902
70962510|NCT02708095|141429715|SUPERIORITY||Odds Ratio (OR)|1.28||||0.392|TWO_SIDED|95.0|0.73|2.27|||Regression, Logistic|||||2.27|0.73|0.392
70962511|NCT02708095|141429715|SUPERIORITY||Odds Ratio (OR)|1.84||||0.041|TWO_SIDED|95.0|1.02|3.29|||Regression, Logistic|||||3.29|1.02|0.041
70962512|NCT02708095|141429716|SUPERIORITY||Odds Ratio, log|1.25||||0.44|TWO_SIDED|95.0|0.71|2.19|||Regression, Logistic|||||2.19|0.71|0.440
70962513|NCT02708095|141429716|SUPERIORITY||Odds Ratio (OR)|2.04||||0.015|TWO_SIDED|95.0|1.15|3.62|||Regression, Logistic|||||3.62|1.15|0.015
70962514|NCT02708095|141429717|SUPERIORITY||LS Mean Difference (Final Vaules)|-0.26||||0.6|TWO_SIDED|95.0|-1.23|0.71|||Mixed Models Analysis|||||0.71|-1.23|0.600
70962515|NCT02708095|141429717|SUPERIORITY||LS Mean Difference (Final Vaules)|-0.58||||0.243|TWO_SIDED|95.0|-1.55|0.39|||Mixed Models Analysis|||||0.39|-1.55|0.243
70962516|NCT02708095|141429718|SUPERIORITY||LS Mean Difference (Final Vaules)|-0.16||||0.285|TWO_SIDED|95.0|-0.45|0.13|||Mixed Models Analysis|||||0.13|-0.45|0.285
70962517|NCT02708095|141429718|SUPERIORITY||LS Mean Difference (Final Vaules)|-0.33||||0.026|TWO_SIDED|95.0|-0.62|-0.04|||Mixed Models Analysis|||||-0.04|-0.62|0.026
70962518|NCT01313650|141429721|SUPERIORITY_OR_OTHER||Least squares mean difference|0.115|||<|0.001|TWO_SIDED|95.0|0.076|0.155|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC 62.5 µg minus Placebo.|||0.155|0.076|<0.001
70962519|NCT01313650|141429721|SUPERIORITY_OR_OTHER||Least squares mean difference|0.072|||<|0.001|TWO_SIDED|95.0|0.032|0.112|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=VI 25 µg minus Placebo.|||0.112|0.032|<0.001
70962520|NCT01313650|141429721|SUPERIORITY_OR_OTHER||Least squares mean difference|0.167|||<|0.001|TWO_SIDED|95.0|0.128|0.207|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus Placebo.|||0.207|0.128|<0.001
70962521|NCT01313650|141429721|SUPERIORITY_OR_OTHER||Least squares mean difference|0.052||||0.004|TWO_SIDED|95.0|0.017|0.087|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 minus UMEC 62.5 µg.|||0.087|0.017|0.004
70962522|NCT01313650|141429721|SUPERIORITY_OR_OTHER||Least squares mean difference|0.095|||<|0.001|TWO_SIDED|95.0|0.06|0.13|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 minus VI 25 µg.|||0.130|0.060|<0.001
70962523|NCT00458341|141429745|OTHER|||||||0.133||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||Baseline of Cycle 1 versus Day 14 of Cycle 1||||0.133
70962524|NCT00458341|141429745|OTHER|||||||0.19||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||Baseline of Cycle 1 versus Day 14 of Cycle 1||||0.190
70962525|NCT00458341|141429745|OTHER|||||||0.123||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||Baseline of Cycle 2 versus Day 14 of Cycle 2||||0.123
70962526|NCT00458341|141429745|OTHER|||||||0.592||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||Baseline of Cycle 2 versus Day 14 of Cycle 2||||0.592
70962527|NCT00458341|141429746|OTHER|||||||0.021|||||||Chi-squared|||Analysis of Cycle 1 data. Analysis was to compare the observed rate with the null hypothesis response rate of 10%.||||0.021
70962528|NCT00458341|141429746|OTHER|||||||0.021|||||||Chi-squared|||Analysis of Cycle 1 data. Analysis was to compare the observed rate with the null hypothesis response rate of 10%.||||0.021
70962529|NCT00458341|141429746|OTHER|||||||0.021|||||||Chi-squared|||Analysis of Cycle 2 data. Analysis was to compare the observed rate with the null hypothesis response rate of 10%.||||0.021
70962530|NCT00458341|141429746|OTHER|||||||0.518|||||||Chi-squared|||Analysis of Cycle 2 data. Analysis was to compare the observed rate with the null hypothesis response rate of 10%.||||0.518
70962531|NCT01389765|141429795|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|1.01|||||TWO_SIDED|90.0|0.97|1.05|||Mixed Models Analysis|Analyzed was a ratio of geometric LS means between the 2 treatment states (fed/fasted), and the 90% confidence interval for the ratio.||||1.05|0.97|
70962532|NCT01389765|141429796|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.96|||||TWO_SIDED|90.0|0.92|1.01|||Mixed Models Analysis|Analyzed was a ratio of geometric LS means between the 2 treatments states (fed/fasted), and the 90% confidence interval for the ratio.||||1.01|0.92|
70962533|NCT01389765|141429797|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.0||||0.0031|TWO_SIDED|90.0|0.5|1.5|||Wilcoxon (Mann-Whitney)|Analyzed were the median of paired differences between the 2 treatment states (fed versus fasted) and the 90% confidence interval.||||1.50|0.50|0.0031
70962534|NCT03877432|141429798|SUPERIORITY|||||||0.012|||||||ANOVA|||All data were presented as means ± standard deviations (SDs). Analysis of variance (ANOVA) was used to compare the effects of 1T stimulation amplitude changes on bladder capacity.||||0.012
70962535|NCT03877432|141429798|SUPERIORITY|||||||0.017|||||||ANOVA|||All data were presented as means ± standard deviations (SDs). Analysis of variance (ANOVA) was used to compare the effects of 2T stimulation amplitude changes on bladder capacity.||||0.017
70962536|NCT03877432|141429798|SUPERIORITY|||||||0.003|||||||ANOVA|||All data were presented as means ± standard deviations (SDs). Analysis of variance (ANOVA) was used to compare the effects of 3T stimulation amplitude changes on bladder capacity.||||0.003
70962537|NCT03877432|141429798|SUPERIORITY|||||||0.004|||||||ANOVA|||All data were presented as means ± standard deviations (SDs). Analysis of variance (ANOVA) was used to compare the effects of 4T stimulation amplitude changes on bladder capacity.||||0.004
70962538|NCT00174265|141429800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0148||95.0||||The test of hypothesis was a 2-tailed test with alpha=0.05 (0.049 to adjust for one interim analysis).|Mixed Model for Repeated Measurements|||The null hypothesis was that there was no difference in change from Baseline in NSA Scale total score between asenapine and olanzapine at Day 365.||||0.0148
70962539|NCT00174265|141429801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81||95.0||||Significant level adjusted for one interim analysis was set as 0.049 two-sided.|Mixed Model for Repeated Measurements|||The null hypothesis was that there was no difference in change from Baseline in QLS total score between asenapine and olanzapine at Week 52.||||0.8100
70962540|NCT03471871|141429809|OTHER||Least squares (LS) mean difference|-0.36||||0.099|TWO_SIDED|95.0|-0.78|0.07||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||||0.07|-0.78|0.099
70962541|NCT03471871|141429809|OTHER||LS mean difference|-0.29||||0.176|TWO_SIDED|95.0|-0.72|0.14||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||||0.14|-0.72|0.176
70962542|NCT03471871|141429810|OTHER||LS mean difference|-0.06||||0.948|TWO_SIDED|95.0|-1.95|1.83||P-Value was at the 0.05 level of significance.|Mixed effect model|AHI was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||||1.83|-1.95|0.948
70962543|NCT03471871|141429811|OTHER||LS mean difference|0.52||||0.639|TWO_SIDED|95.0|-1.72|2.76||P-Value was at the 0.05 level of significance.|Mixed effect model|AHI was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||||2.76|-1.72|0.639
70962544|NCT03471871|141429811|OTHER||LS mean difference|-1.16||||0.297|TWO_SIDED|95.0|-3.4|1.08||P-Value was at the 0.05 level of significance.|mixed effect model|AHI was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||||1.08|-3.40|0.297
70962545|NCT03471871|141429812|OTHER||LS mean difference|-0.03||||0.979|TWO_SIDED|95.0|-2.22|2.17||P-Value was at the 0.05 level of significance.|Mixed effect model|AHI was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||||2.17|-2.22|0.979
70962546|NCT03471871|141429813|OTHER||LS mean difference|0.185||||0.095|TWO_SIDED|95.0|-0.034|0.405||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||SpO2 is \<90%||0.405|-0.034|0.095
70962547|NCT03471871|141429813|OTHER||LS mean difference|0.245||||0.03|TWO_SIDED|95.0|0.025|0.464||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||When SpO2 is \<90%||0.464|0.025|0.030
70962548|NCT03471871|141429813|OTHER||LS mean difference|0.004||||0.885|TWO_SIDED|95.0|-0.058|0.067||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||SpO2 is \<85%||0.067|-0.058|0.885
70962549|NCT03471871|141429813|OTHER||LS mean difference|0.044||||0.158|TWO_SIDED|95.0|-0.018|0.107||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||SpO2 is \<85%||0.107|-0.018|0.158
70962550|NCT03471871|141429813|OTHER||LS mean difference|0.001||||0.462|TWO_SIDED|95.0|-0.002|0.005||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||SpO2 is \<80%||0.005|-0.002|0.462
70962551|NCT03471871|141429813|OTHER||LS mean difference|0.002||||0.166|TWO_SIDED|95.0|-0.001|0.006||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||SpO2 is \<80%||0.006|-0.001|0.166
70962552|NCT03471871|141429815|OTHER||LS mean difference|0.07||||0.699|TWO_SIDED|95.0|-0.31|0.46||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 1: Mean SpO2 during TST||0.46|-0.31|0.699
70962553|NCT03471871|141429815|OTHER||LS mean difference|0.25||||0.169|TWO_SIDED|95.0|-0.11|0.61||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 8: Mean SpO2 during TST||0.61|-0.11|0.169
70962554|NCT03471871|141429816|OTHER||LS mean difference|0.312||||0.472|TWO_SIDED|95.0|-0.558|1.181||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 1: SpO2 is \<90%||1.181|-0.558|0.472
70962555|NCT03471871|141429816|OTHER||LS mean difference|0.067||||0.479|TWO_SIDED|95.0|-0.124|0.258||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 1: SpO2 is \<85%||0.258|-0.124|0.479
70962556|NCT03471871|141429816|OTHER||LS mean difference|0.002||||0.852|TWO_SIDED|95.0|-0.019|0.023||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 1: SpO2 is \<80%||0.023|-0.019|0.852
70962557|NCT03471871|141429816|OTHER||LS mean difference|0.088||||0.733|TWO_SIDED|95.0|-0.431|0.607||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 8: SpO2 is \<90%||0.607|-0.431|0.733
70962558|NCT03471871|141429816|OTHER||LSM difference|0.056||||0.518|TWO_SIDED|95.0|-0.117|0.228||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 8: When SpO2 is \<85%||0.228|-0.117|0.518
70962559|NCT03471871|141429816|OTHER||LS mean difference|0.006||||0.576|TWO_SIDED|95.0|-0.015|0.026||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 8: SpO2 is \<80%||0.026|-0.015|0.576
70962560|NCT04600336|141429819|SUPERIORITY||Mean Difference (Final Values)|-9.11||||0.0019|TWO_SIDED|90.0|-13.76|-4.46|||t-test, 2 sided|||||-4.46|-13.76|0.0019
70962561|NCT04600336|141429819|SUPERIORITY||Mean Difference (Final Values)|-5.09||||0.0732|TWO_SIDED|90.0|-9.7|-0.48|||t-test, 2 sided|||||-0.48|-9.70|0.0732
70962562|NCT04600336|141429822|SUPERIORITY|||||||0.012|||||||Kruskal-Wallis|||||||0.0120
70962563|NCT04600336|141429825|SUPERIORITY|||||||0.0057|||||||Kruskal-Wallis|||||||0.0057
70962564|NCT03971422|141429868|SUPERIORITY||LS Mean Difference|-2.586|||<|0.001|TWO_SIDED|95.0|-4.091|-1.249||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||Mixed model repeated measure (MMRM) ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-1.249|-4.091|<0.001
70962565|NCT03971422|141429868|SUPERIORITY||LS Mean Difference|-2.619|||<|0.001|TWO_SIDED|95.0|-3.994|-1.163||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM analysis of covariance (ANCOVA) model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-1.163|-3.994|<0.001
70962566|NCT03971422|141429869|SUPERIORITY||Odds Ratio (OR)|5.765|||<|0.001|TWO_SIDED|95.0|2.1|14.882||p-value is nominal. Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Wald test||The OR of responder rates is estimated and tested between treatment groups using logistic regression model with treatment group, Baseline MG-ADL score and stratification factor (MuSK+ or AChR+). An OR \> 1 favours rozanolixizumab.|||14.882|2.100|<0.001
70962567|NCT03971422|141429869|SUPERIORITY||Odds Ratio (OR)|4.273|||<|0.001|TWO_SIDED|95.0|1.653|11.791||p-value is nominal. Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Wald test||The OR of responder rates is estimated and tested between treatment groups using logistic regression model with treatment group, Baseline MG-ADL score and stratification factor (MuSK+ or AChR+). An OR \> 1 favours rozanolixizumab.|||11.791|1.653|<0.001
70962568|NCT03971422|141429870|SUPERIORITY||LS Mean Difference|-3.901|||<|0.001|TWO_SIDED|95.0|-6.634|-1.245||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-1.245|-6.634|<0.001
70962569|NCT03971422|141429870|SUPERIORITY||LS Mean Difference|-5.525|||<|0.001|TWO_SIDED|95.0|-8.303|-2.968||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-2.968|-8.303|<0.001
70962570|NCT03971422|141429871|SUPERIORITY||LS Mean Difference|-3.483|||<|0.001|TWO_SIDED|95.0|-5.614|-1.584||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-1.584|-5.614|<0.001
70962571|NCT03971422|141429871|SUPERIORITY||LS Mean Difference|-4.756|||<|0.001|TWO_SIDED|95.0|-6.821|-2.859||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-2.859|-6.821|<0.001
70962572|NCT03971422|141429872|SUPERIORITY||LS Mean Difference|-12.441|||<|0.001|TWO_SIDED|95.0|-21.804|-4.089||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-4.089|-21.804|<0.001
70962573|NCT03971422|141429872|SUPERIORITY||LS Mean Difference|-15.163|||<|0.001|TWO_SIDED|95.0|-23.596|-6.45||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-6.450|-23.596|<0.001
70962574|NCT03971422|141429873|SUPERIORITY||LS Mean Difference|-8.65||||0.012|TWO_SIDED|95.0|-18.058|-0.134||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-0.134|-18.058|0.012
70962575|NCT03971422|141429873|SUPERIORITY||LS Mean Difference|-14.822|||<|0.001|TWO_SIDED|95.0|-23.759|-5.936||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-5.936|-23.759|<0.001
70962576|NCT03971422|141429874|SUPERIORITY||LS Mean Difference|-11.32|||<|0.001|TWO_SIDED|95.0|-18.958|-4.998||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-4.998|-18.958|<0.001
70962577|NCT03971422|141429874|SUPERIORITY||LS Mean Difference|-10.705|||<|0.001|TWO_SIDED|95.0|-17.787|-3.998||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-3.998|-17.787|<0.001
70962578|NCT03566810|141429877|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric Least Square(LS)Mean%|98.69|||||TWO_SIDED|90.0|92.2|105.64||||||Statistical Comparison of Test GXR Versus Reference GXR under Fasting conditions.||105.64|92.20|
70962579|NCT03566810|141429877|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric LS Mean Percentage|99.39|||||TWO_SIDED|90.0|93.15|106.05||||||Statistical Comparison of Test GXR Versus Reference GXR under Fed conditions.||106.05|93.15|
70962580|NCT03566810|141429878|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric LS Mean Percentage|98.92|||||TWO_SIDED|90.0|91.08|107.44||||||Statistical Comparison of Test GXR Versus Reference GXR under Fasting conditions.||107.44|91.08|
70962581|NCT03566810|141429878|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric LS Mean Percentage|96.89|||||TWO_SIDED|90.0|89.87|104.46||||||Statistical Comparison of Test GXR Versus Reference GXR under Fed conditions.||104.46|89.87|
70962582|NCT03566810|141429879|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Median point estimate difference|0.0|||||TWO_SIDED|90.0|-0.5|0.0||||||Statistical Comparison of Test GXR Versus Reference GXR under Fasting conditions.||0.00|-0.50|
70962583|NCT03566810|141429879|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Median point estimate difference|0.0|||||TWO_SIDED|90.0|-0.5|0.5||||||Statistical Comparison of Test GXR Versus Reference GXR under Fed conditions.||0.50|-0.50|
70962584|NCT03566810|141429881|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric LS Mean Percentage|97.89|||||TWO_SIDED|90.0|91.38|104.86||||||Statistical Comparison of Test GXR Versus Reference GXR under Fasting conditions.||104.86|91.38|
70881324|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.28||||0.2085|TWO_SIDED|80.0|-5.88|1.33|||Mixed Models Analysis|||Change from baseline at Day 281||1.33|-5.88|0.2085
70881325|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.94||||0.6335|TWO_SIDED|80.0|-2.61|4.49|||Mixed Models Analysis|||Change from baseline at Day 281||4.49|-2.61|0.6335
70881326|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.64||||0.1778|TWO_SIDED|80.0|-6.31|1.03|||Mixed Models Analysis|||Change from baseline at Day 309||1.03|-6.31|0.1778
70962585|NCT03566810|141429881|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric LS Mean Percentage|98.08|||||TWO_SIDED|90.0|92.37|104.14||||||Statistical Comparison of Test GXR Versus Reference GXR under Fed conditions.||104.14|92.37|
70962586|NCT02087748|141429904|SUPERIORITY_OR_OTHER|||||||0.0324|||||||t-test, 2 sided|||||||0.0324
70962587|NCT02087748|141429905|SUPERIORITY_OR_OTHER|||||||0.3688|||||||t-test, 2 sided|||||||0.3688
70962588|NCT02087748|141429906|SUPERIORITY_OR_OTHER|||||||0.0275|||||||t-test, 2 sided|||||||0.0275
70962589|NCT03078907|141429916|OTHER||Least Square (LS) mean|13.79|STANDARD_ERROR_OF_MEAN|13.695|||TWO_SIDED|95.0|13.366|40.944|||ANCOVA|||Daily time spent in non-sedentary activity (minutes), Freedson '98||40.944|13.366|
70962590|NCT03078907|141429916|OTHER||LS means|2.31|STANDARD_ERROR_OF_MEAN|6.601|||TWO_SIDED|95.0|-10.782|15.396|||ANCOVA|||Daily time spent in MVPA (minutes), Freedson '98||15.396|-10.782|
70962591|NCT03078907|141429916|OTHER||LS mean|17.81|STANDARD_ERROR_OF_MEAN|12.008|||TWO_SIDED|95.0|-6.003|41.619|||ANCOVA|||Daily time spent in non-sedentary activity (minutes), Koster '16||41.619|-6.003|
70962592|NCT03078907|141429917|OTHER||LS mean|0.67|STANDARD_ERROR_OF_MEAN|1.204|||TWO_SIDED|95.0|-1.713|3.06|||ANCOVA|||Percentage of daily time spent in non-sedentary activity (%), Freedson '98||3.060|-1.713|
70962593|NCT03078907|141429917|OTHER||LS mean|-0.05|STANDARD_ERROR_OF_MEAN|0.658|||TWO_SIDED|95.0|-1.351|1.258|||ANCOVA|||Percentage of daily time spent in MVPA (%), Freedson '98||1.258|-1.351|
70962594|NCT03078907|141429917|OTHER||LS mean|1.26|STANDARD_ERROR_OF_MEAN|1.191|||TWO_SIDED|95.0|-1.104|3.618|||ANCOVA|||Percentage of daily time spent in non-sedentary activity (%), Koster '16||3.618|-1.104|
70962595|NCT03078907|141429918|OTHER||LS mean|20.66|STANDARD_ERROR_OF_MEAN|63.695|||TWO_SIDED|95.0|-105.632|146.958|||ANCOVA|||Volume of total daily activities (counts / minute)||146.958|-105.632|
70962596|NCT03078907|141429918|OTHER||LS means|27.52|STANDARD_ERROR_OF_MEAN|65.291|||TWO_SIDED|95.0|-101.945|156.976|||ANCOVA|||Volume of non-sedentary activity (counts/minute), Koster '16||156.976|-101.945|
70962597|NCT03078907|141429919|OTHER||LS means|58409.0|STANDARD_ERROR_OF_MEAN|64985.0|||TWO_SIDED|95.0|-70444.0|187263.0|||ANCOVA|||||187263|-70444|
70881327|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.7||||0.4027|TWO_SIDED|80.0|-4.33|2.94|||Mixed Models Analysis|||Change from baseline at Day 309||2.94|-4.33|0.4027
70962598|NCT03078907|141429920|OTHER||LS means|201.59|STANDARD_ERROR_OF_MEAN|224.212|||TWO_SIDED|95.0|-242.977|646.163|||ANCOVA|||||646.163|-242.977|
70962599|NCT03078907|141429921|OTHER||LS means|0.07|STANDARD_ERROR_OF_MEAN|0.221|||TWO_SIDED|95.0|-0.366|0.51|||ANCOVA|||||0.510|-0.366|
70962600|NCT00826111|141429938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0085|STANDARD_ERROR_OF_MEAN|0.0534||0.88|TWO_SIDED|95.0|-0.139|0.0122|||t-test, 2 sided|||||.01220|-0.1390|0.88
70962601|NCT00826111|141429939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.031|STANDARD_ERROR_OF_MEAN|0.112||0.79|TWO_SIDED|95.0|-0.286|0.224|||t-test, 2 sided|||||0.224|-0.286|0.79
70962602|NCT00826111|141429940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0222|STANDARD_ERROR_OF_MEAN|0.0128||0.16|TWO_SIDED|95.0|-0.58|0.0136|||t-test, 2 sided|||||.0136|-0.580|0.16
70962603|NCT00826111|141429941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|0.515||0.29|TWO_SIDED|95.0|-1.35|2.77|||t-test, 2 sided|||||2.77|-1.35|0.29
70962604|NCT00826111|141429942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0048|STANDARD_ERROR_OF_MEAN|0.005||0.37|TWO_SIDED|95.0|-0.0077|0.0174|||t-test, 2 sided|||||0.0174|-0.0077|0.37
70962605|NCT00826111|141429943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0056|STANDARD_ERROR_OF_MEAN|0.0042||0.21|TWO_SIDED|95.0|-0.0037|0.1481|||t-test, 2 sided|||||0.1481|-0.0037|0.21
70962606|NCT00826111|141429944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.35|STANDARD_ERROR_OF_MEAN|3.94||0.1|TWO_SIDED|95.0|-1.76|16.46|||t-test, 2 sided|||||16.46|-1.76|0.10
70962607|NCT00826111|141429945|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|4.06||0.89|TWO_SIDED|95.0|-9.31|10.51|||t-test, 2 sided|||||10.51|-9.31|0.89
70962608|NCT00826111|141429946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|3.78||0.66|TWO_SIDED|95.0|-10.31|6.91|||t-test, 2 sided|||||6.91|-10.31|0.66
70962609|NCT01672788|141429947|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose|Geometric Mean Ratio|101.31|STANDARD_DEVIATION|10.7|||TWO_SIDED|90.0|96.89|105.93|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||105.93|96.89|
70962610|NCT01672788|141429947|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose|Geometric Mean Ratio|100.3|STANDARD_DEVIATION|7.0|||TWO_SIDED|90.0|97.4|103.29|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||103.29|97.40|
70962611|NCT01672788|141429948|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose.|Geometric Mean Ratio|101.61|STANDARD_DEVIATION|8.8|||TWO_SIDED|90.0|97.94|105.41|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the gCV|||105.41|97.94|
70962612|NCT01672788|141429948|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose.|Geometric Mean Ratio|98.56|STANDARD_DEVIATION|10.8|||TWO_SIDED|90.0|94.24|103.08|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the gCV|||103.08|94.24|
70962613|NCT01672788|141429949|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose|Geometric Mean Ratio|101.2|STANDARD_DEVIATION|10.4|||TWO_SIDED|90.0|96.89|105.71|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||105.71|96.89|
70962614|NCT01672788|141429949|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose|Geometric Mean Ratio|100.31|STANDARD_DEVIATION|7.0|||TWO_SIDED|90.0|97.41|103.3|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the gCV|||103.30|97.41|
70962615|NCT01672788|141429950|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose|Geometric Mean Ratio|102.7|STANDARD_DEVIATION|9.4|||TWO_SIDED|90.0|98.75|106.81|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||106.81|98.75|
70962616|NCT01672788|141429950|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose|Geometric Mean Ratio|100.97|STANDARD_DEVIATION|12.3|||TWO_SIDED|90.0|95.94|106.27|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the gCV|||106.27|95.94|
70962617|NCT01672788|141429951|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose .|Geometric Mean Ratio|99.64|STANDARD_DEVIATION|10.5|||TWO_SIDED|90.0|95.39|104.09|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||104.09|95.39|
70962618|NCT01672788|141429951|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose.|Geometric Mean Ratio|97.89|STANDARD_DEVIATION|10.2|||TWO_SIDED|90.0|93.82|102.15|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the gCV|||102.15|93.82|
70962619|NCT01672788|141429952|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose .|Geometric Mean Ratio|101.51|STANDARD_DEVIATION|8.6|||TWO_SIDED|90.0|97.95|105.21|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||105.21|97.95|
70962620|NCT01672788|141429952|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose .|Geometric Mean Ratio|98.57|STANDARD_DEVIATION|10.1|||TWO_SIDED|90.0|94.5|102.81|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the gCV|||102.81|94.50|
70962621|NCT04697264|141429973|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.026||||||Adjustments to the p-values for multiple comparison were performed using Benjamini and Hochberg approach on 'R' and represented in the text as adjusted p-value.|Regression, Linear|||The influence of age on adiponectin levels was analysed by dividing the population into binary groups (\<60 years and \>/= 60 years) to facilitate comparison.||||0.026
70881328|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.94||||0.757|TWO_SIDED|80.0|-1.64|5.53|||Mixed Models Analysis|||Change from baseline at Day 309||5.53|-1.64|0.7570
70881329|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.9||||0.1132|TWO_SIDED|80.0|-8.03|0.23|||Mixed Models Analysis|||Change from baseline at Day 337||0.23|-8.03|0.1132
70881330|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.71||||0.1965|TWO_SIDED|80.0|-6.8|1.37|||Mixed Models Analysis|||Change from baseline at Day 337||1.37|-6.80|0.1965
70881331|NCT02515942|141247223|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.18||||0.6471|TWO_SIDED|80.0|-2.85|5.21|||Mixed Models Analysis|||Change from baseline at Day 337||5.21|-2.85|0.6471
70881332|NCT01649375|141247251|SUPERIORITY||Odds Ratio (OR)|1.82||||0.0967|TWO_SIDED|95.0|0.9|3.67|||Regression, Logistic|Missing ASAS responses considered nonresponders||||3.67|0.90|0.0967
70881333|NCT01649375|141247251|SUPERIORITY||Odds Ratio (OR)|4.38|||<|0.0001|TWO_SIDED|95.0|2.14|8.96|||Regression, Logistic|Missing ASAS responses considered nonresponders||||8.96|2.14|<.0001
70881334|NCT01649375|141247252|SUPERIORITY||Odds Ratio (OR)|2.99||||0.0194|TWO_SIDED|95.0|1.19|7.48|||Regression, Logistic|Missing ASAS responses considered nonresponders||||7.48|1.19|0.0194
70881335|NCT01649375|141247252|SUPERIORITY||Odds Ratio (OR)|5.07|||<|0.0004|TWO_SIDED|95.0|2.06|12.44|||Regression, Logistic|Missing ASAS responses considered nonresponders||||12.44|2.06|<.0004
70881336|NCT01649375|141247253|SUPERIORITY||Mean Difference (Net)|0.54|||<|0.0001|TWO_SIDED|95.0|0.41|0.71|||Mixed Models Analysis|||||0.71|0.41|<0.0001
70881337|NCT01649375|141247253|SUPERIORITY||Mean Difference (Net)|0.49|||<|0.0001|TWO_SIDED|95.0|0.37|0.64|||Mixed Models Analysis|||||0.64|0.37|<0.0001
70881338|NCT01649375|141247254|SUPERIORITY||Odds Ratio (OR)|6.13||||0.0003|TWO_SIDED|95.0|2.31|16.26|||Regression, Logistic|Missing ASAS responses considered nonresponders||||16.26|2.31|0.0003
70881339|NCT01649375|141247254|SUPERIORITY||Odds Ratio (OR)|9.15|||<|0.0001|TWO_SIDED|95.0|3.47|24.12|||Regression, Logistic|Missing ASAS responses considered nonresponders||||24.12|3.47|<.0001
70881340|NCT01649375|141247255|SUPERIORITY||Mean Difference (Net)|-1.07|STANDARD_ERROR_OF_MEAN|0.353|<|0.0001|TWO_SIDED|95.0|-1.77|-0.37|||Mixed Models Analysis|||||-0.37|-1.77|<0.0001
70881341|NCT01649375|141247255|SUPERIORITY||Mean Difference (Net)|-1.34|STANDARD_ERROR_OF_MEAN|0.353||0.0002|TWO_SIDED|95.0|-2.04|-0.65|||Mixed Models Analysis|||||-0.65|-2.04|0.0002
70881342|NCT01649375|141247256|SUPERIORITY||Mean Difference (Net)|2.84|STANDARD_ERROR_OF_MEAN|1.108||0.011|TWO_SIDED|95.0|0.66|5.03|||Mixed Models Analysis|||||5.03|0.66|0.0110
70881343|NCT01649375|141247256|SUPERIORITY||Mean Difference (Net)|4.14|STANDARD_ERROR_OF_MEAN|1.105||0.0002|TWO_SIDED|95.0|1.96|6.32|||Mixed Models Analysis|||||6.32|1.96|0.0002
70881344|NCT01649375|141247257|SUPERIORITY||Mean Difference (Net)|-1.96|STANDARD_ERROR_OF_MEAN|0.748||0.0096|TWO_SIDED|95.0|-3.43|-0.48|||Mixed Models Analysis|||||-0.48|-3.43|0.0096
70881345|NCT01649375|141247257|SUPERIORITY||Mean Difference (Net)|-2.63|STANDARD_ERROR_OF_MEAN|0.743||0.0005|TWO_SIDED|95.0|-4.09|-1.16|||Mixed Models Analysis|||||-1.16|-4.09|0.0005
70881346|NCT01649375|141247258|SUPERIORITY||Odds Ratio (OR)|4.28||||0.0325|TWO_SIDED|95.0|1.13|16.21|||Regression, Logistic|Missing ASAS responses considered nonresponders||||16.21|1.13|0.0325
70881347|NCT01649375|141247258|SUPERIORITY||Odds Ratio (OR)|3.91||||0.0471|TWO_SIDED|95.0|1.02|15.01|||Regression, Logistic|Missing ASAS responses considered nonresponders||||15.01|1.02|0.0471
70881348|NCT01762943|141247263|SUPERIORITY|||||||0.27|||||||repeated measures ANOVA|F=1.40, df=2,26||||||.27
70881349|NCT01762943|141247264|SUPERIORITY|||||||0.018|||||||repeated measures ANOVA|F=6.29, df=1,28||||||.018
70881350|NCT00952341|141247315|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Regression, Logistic|||"Adjusted by gender and concomitant~chemotherapy.~The apriori significance level was set at 0.05.~There was no adjustment for multiplicity."||||0.007
70881351|NCT00952341|141247316|SUPERIORITY_OR_OTHER|||||||0.942||95.0|||||Regression, Logistic|||"Adjusted by gender and concomitant chemotherapy.~The apriori significance level was set at 0.05.~There was no adjustment for multiplicity."||||0.942
70881352|NCT00952341|141247317|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Regression, Logistic|||"Adjusted by gender and concomitant chemotherapy.~The apriori significance level was set at 0.05.~There was no adjustment for multiplicity."||||0.001
70881353|NCT00952341|141247318|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Regression, Logistic|||"Adjusted by gender and concomitant~chemotherapy."||||0.003
70881354|NCT00952341|141247319|SUPERIORITY_OR_OTHER|||||||0.882||95.0|||||Regression, Logistic|||Adjusted by gender and concomitant chemotherapy.||||0.882
70881355|NCT00952341|141247320|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Regression, Logistic|||Adjusted by gender and concomitant chemotherapy.||||0.001
70881356|NCT01232920|141247334|SUPERIORITY_OR_OTHER|||||||0.09|||||||Fisher Exact|||||||0.09
70962622|NCT04697264|141429973|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.496||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of age on adiponectin levels was analysed by dividing the population into binary groups (\<60years and \>/=60years) to facilitate comparison.||||0.496
70962623|NCT04697264|141429973|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.|||||>|0.05|||||||Regression, Linear|||The influence of age on leptin levels was analysed by dividing the population into binary groups (\<60years and \>/=60years) to facilitate comparison.||||>0.05
70962624|NCT04697264|141429973|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.|||||>|0.05||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of age on IGF1 and 2 levels were analysed by dividing the population into binary groups (\<60years and \>/=60years) to facilitate comparison.||||>0.05
70962625|NCT04697264|141429973|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|||||>|0.05||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of age on IGF1 and 2 levels were analysed by dividing the population into binary groups (\<60years and \>/=60years) to facilitate comparison.||||>0.05
70962626|NCT04697264|141429973|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.|||||>|0.05||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of menopausal status on levels of adiponectin, leptin, IGF1 and 2 were analysed by dividing the population into binary groups (pre-menopausal and menopausal) to facilitate comparison.||||>0.05
70962627|NCT04697264|141429973|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.014||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of menopausal status on levels of adiponectin was analysed by dividing the population into binary groups (pre-menopausal and menopausal) to facilitate comparison.||||0.014
70962628|NCT04697264|141429973|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.006||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of menopausal status on levels of leptin was analysed by dividing the population into binary groups (pre-menopausal and menopausal) to facilitate comparison.||||0.006
70962629|NCT04697264|141429973|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.019||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of menopausal status on levels of IGF1 and IGF2 were analysed by dividing the population into binary groups (pre-menopausal and menopausal) to facilitate comparison.||||0.019
70962630|NCT04697264|141429974|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.033||||||Adjustments to the p-values for multiple comparison were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||Effects of LVSI on adiponectin levels were assessed using multivariate linear regression, with binary categorisations (presence and absence of LVSI) to facilitate comparisons.||||0.033
70962631|NCT04697264|141429974|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.015||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||Effects of MELF on TNF levels were assessed using multivariate linear regression, with binary categorisations (presence and absence of MELF) to facilitate comparisons.||||0.015
70962632|NCT04697264|141429974|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.|||||>|0.05||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||Effects of tumour grade (Grade 1/2), stage (Stage 1/ \>/=1), histology (type 1 and type 2), and MSI (presence or absence) on the biomarker levels (adiponectin, leptin, IGF 1 and 2, IL6 and TNF) were assessed using multivariate linear regression, with binary categorisations to facilitate comparisons.||||>0.05
70962633|NCT04697264|141429975|OTHER||||||<|0.0001||||||Adjustments to the p-values for multiple comparison were performed using the Benjamini and Hochberg approach in 'R'.|Regression, Linear|||To compare biomarker levels between study and control populations, a linear regression model was used, adjusting for BMI, diabetes, and parity, which are the unmatched factors between the study and control groups. This adjustment aimed to mitigate the confounding impact of these factors, considering their individual influence on the risk of endometrial cancer.||||<0.0001
70881357|NCT00755131|141247339|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Sample size determination was based on a t-test assuming a normal distribution with non-equal variance with the mean and standard deviation for the experimental group (postinfarction patients) of HMGB1 levels equal to 15 ± 7 and 2 ± 1 ng/dl for the control group derived from a previous study, respectively. The required sample size was calculated to be 30 subjects per group to detect on the size of one SD with α value of 0.05 (two-sided) and power (1 - β) of 0.8.||||<0.05
70881358|NCT00755131|141247340|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
70881359|NCT00755131|141247341|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
70881360|NCT01480076|141247351|SUPERIORITY_OR_OTHER||||||<|0.0001||||||within group p-value|mixed effect model|||Month 3: Mixed effect model for repeated measures with visit, baseline PCS score, baseline Expanded Disability Status Scale (EDSS) score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881361|NCT01480076|141247351|SUPERIORITY_OR_OTHER||||||<|0.0001||||||within group p-value|mixed effect model|||Month 6: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70962634|NCT04697264|141429976|OTHER||||||>|0.05||||||Adjustments to the p-values for multiple comparison were performed using the Benjamini and Hochberg approach in 'R'.|Regression, Linear|||To compare biomarker levels between study and control populations, a linear regression model was used, adjusting for BMI, diabetes, and parity, which are the unmatched factors between the study and control groups. This adjustment aimed to mitigate the confounding impact of these factors, considering their individual influence on the risk of endometrial cancer.||||>0.05
70962635|NCT04697264|141429977|OTHER||||||<|0.05||||||Adjustments to the p-values for multiple comparison were performed using the Benjamini and Hochberg approach in 'R'.|Regression, Linear|||To compare biomarker levels between study and control populations, a linear regression model was used, adjusting for BMI, diabetes, and parity, which are the unmatched factors between the study and control groups. This adjustment aimed to mitigate the confounding impact of these factors, considering their individual influence on the risk of endometrial cancer.||||<0.05
70881362|NCT01480076|141247351|SUPERIORITY_OR_OTHER||least squares mean|0.8|STANDARD_ERROR_OF_MEAN|0.22||0.0007|TWO_SIDED||||||mixed effect model|||Difference of Month 3 versus Month 6: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0007
70881363|NCT01480076|141247351|SUPERIORITY_OR_OTHER||||||<|0.0001||||||within-group p-value|mixed effect model|||Month 9: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881364|NCT01480076|141247351|SUPERIORITY_OR_OTHER||least squares mean|0.2|STANDARD_ERROR_OF_MEAN|0.21||0.2531|TWO_SIDED||||||mixed effect model|||Difference of Month 6 versus Month 9: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2531
70881365|NCT01480076|141247351|SUPERIORITY_OR_OTHER||||||<|0.0001||||||within group p-value|mixed effect model|||Month 12: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881366|NCT01480076|141247351|SUPERIORITY_OR_OTHER||least squares mean|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.2299|TWO_SIDED||||||mixed effect model|||Difference of Month 9 versus Month 12: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2299
70881367|NCT01480076|141247352|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881368|NCT01480076|141247352|SUPERIORITY_OR_OTHER|||||||0.5405|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5405
70881369|NCT01480076|141247352|SUPERIORITY_OR_OTHER||least squares mean|3.7|STANDARD_ERROR_OF_MEAN|0.58|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881370|NCT01480076|141247352|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881371|NCT01480076|141247352|SUPERIORITY_OR_OTHER|||||||0.7272|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7272
70881372|NCT01480076|141247352|SUPERIORITY_OR_OTHER||least squares mean|4.3|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881373|NCT01480076|141247352|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881374|NCT01480076|141247352|SUPERIORITY_OR_OTHER|||||||0.7484|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7484
70881375|NCT01480076|141247352|SUPERIORITY_OR_OTHER||least squares mean|3.0|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70962636|NCT04697264|141429978|OTHER||||||>|0.05||||||Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. P value \<0.05 was considered significant.|Regression, Linear|||"The impact of BMI on biomarker levels was assessed by categorising the population into two groups-normal weight and overweight/obese-for straightforward comparison.~Here, we present the associations between adiponectin and the BMI of the study population at baseline."||||>0.05
70962637|NCT04697264|141429978|OTHER|||||||0.09||||||Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. P value \<0.05 was considered significant.|Regression, Linear|||"The impact of BMI on biomarker levels was assessed by categorising the population into two groups-normal weight and overweight/obese-for straightforward comparison.~Here, we present the associations between leptin and the BMI of the study population at baseline."||||0.09
70962638|NCT04697264|141429978|OTHER||||||>|0.05||||||Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. P value \<0.05 was considered significant.|Regression, Linear|||"The impact of BMI on biomarker levels was assessed by categorising the population into two groups-normal weight and overweight/obese-for straightforward comparison.~Here, we present the association between IL6, TNFα, IGF1, and IGF2 and the BMI of the study population at baseline."||||>0.05
70962639|NCT04697264|141429979|OTHER|||||||0.004||||||Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. P value \<0.05 was considered significant.|Regression, Linear|||"The impact of BMI on biomarker levels was assessed by categorising the population into two groups-normal weight and overweight/obese-for straightforward comparison.~Here, we present the associations between adiponectin and the BMI of the control population at baseline."||||0.004
70962640|NCT04697264|141429979|OTHER|||||||0.0002||||||Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. P value \<0.05 was considered significant.|Regression, Linear|||"The impact of BMI on biomarker levels was assessed by categorising the population into two groups-normal weight and overweight/obese-for straightforward comparison.~Here, we present the associations between leptin and the BMI of the control population at baseline."||||0.0002
70962641|NCT04697264|141429979|OTHER||||||>|0.05||||||Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. P value \<0.05 was considered significant.|Regression, Linear|||"The impact of BMI on biomarker levels was assessed by categorising the population into two groups-normal weight and overweight/obese-for straightforward comparison.~Here, we present the associations between IL6, TNFα, IGF1, and IGF2 and the BMI of the control population at baseline."||||>0.05
70962642|NCT04697264|141429980|OTHER|||||||0.0007||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Mixed Models Analysis|||||||0.0007
70962643|NCT04697264|141429981|OTHER||||||>|0.05||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Mixed Models Analysis|||Leptin levels were compared between the day 0 and 6 months post-operative bloods.||||>0.05
70962644|NCT04697264|141429981|OTHER|||||||0.004||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Mixed Models Analysis|||IGF1 levels were compared between the day 0 and 6 months post-operative bloods.||||0.004
70962645|NCT04697264|141429981|OTHER||||||<|0.0001||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Mixed Models Analysis|||IGF2 levels were compared between the day 0 and 6 months post-operative bloods.||||<0.0001
70962646|NCT04697264|141429983|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Expression of adiponectin was studied in endometrial cancer tissue and fat tissue using qRT-PCR.||||<0.0001
70962647|NCT04697264|141429983|OTHER||||||<|0.05|||||||t-test, 2 sided|||Expression of leptin and their receptors were studied in endometrial cancer tissue and fat tissue using qRT-PCR.||||<0.05
70962648|NCT04697264|141429983|OTHER||||||>|0.05|||||||t-test, 2 sided|||Expression of adiponectin receptors were studied in endometrial cancer tissue and fat tissue using qRT-PCR.||||>0.05
70962649|NCT04697264|141429984|OTHER|||||||0.0002|||||||t-test, 2 sided|||Expression of adiponectin was studied in endometrial cancer tissue and lymph node tissue using qRT-PCR.||||0.0002
70962650|NCT04697264|141429984|OTHER|||||||0.011|||||||t-test, 2 sided|||Expression of leptin was studied in endometrial cancer tissue and lymphnode tissue using qRT-PCR.||||0.011
70962651|NCT04697264|141429984|OTHER|||||||0.009|||||||t-test, 2 sided|||The expression of IL6 receptor (IL6R) was studied in endometrial cancer tissue and lymphnode tissue using qRT-PCR.||||0.009
70962652|NCT04697264|141429984|OTHER||||||>|0.05|||||||t-test, 2 sided|||The expression of adiponectin receptor, leptin receptor, IGF1 and IGF 2 receptors, IL6, TNF, IGF1 and IGF2 were studied in endometrial cancer tissue and lymphnode tissue using qRT-PCR.||||>0.05
70962653|NCT04697264|141429985|OTHER||||||>|0.05|||||||Pearson's correlation test|||Circulating adiponectin levels and the expression of these markers and their receptors in endometrial tissue were compared using correlation studies.||||>0.05
70962654|NCT04697264|141429986|OTHER||||||>|0.05|||||||Pearson's correlation test|||Circulating leptin, IGF1 and IGF2 levels and the expression of these markers and their receptors in endometrial tissue were compared using Pearson's correlation studies.||||>0.05
70962655|NCT04697264|141429987|OTHER||||||>|0.05|||||||Pearson's correlation test|||Circulating IL6 and TNF levels and the expression of these markers and their receptors in endometrial tissue were compared using Pearson's correlation studies.||||>0.05
70962656|NCT04682977|141430110|SUPERIORITY||Mean difference (adjusted)|1.58|STANDARD_ERROR_OF_MEAN|0.76||0.04|TWO_SIDED|||||Sidak correction for multiple comparisons.|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF-Control|||||0.04
70962657|NCT04682977|141430111|SUPERIORITY||Mean difference (adjusted)|1.98|STANDARD_ERROR_OF_MEAN|1.75||0.26|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF-Control|||||0.26
70962658|NCT04682977|141430112|SUPERIORITY||Mean difference (adjusted)|-1.06|STANDARD_ERROR_OF_MEAN|1.6||0.51|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF-Control|||||0.51
70962659|NCT04682977|141430113|SUPERIORITY||Mean difference (adjusted)|2.17|STANDARD_ERROR_OF_MEAN|1.78||0.23|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF - Control|||||0.23
70962660|NCT04682977|141430114|SUPERIORITY||Mean difference (adjusted)|4.65|STANDARD_ERROR_OF_MEAN|5.97||0.44|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF - Control|||||0.44
70962661|NCT04682977|141430115|SUPERIORITY||Mean difference (adjusted)|4.37|STANDARD_ERROR_OF_MEAN|3.47||0.22|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF - Control|||||0.22
70962662|NCT04682977|141430116|SUPERIORITY||Mean difference (adjusted)|0.91|STANDARD_ERROR_OF_MEAN|1.8||0.91|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF - Control|||||0.91
70881376|NCT01480076|141247352|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881377|NCT01480076|141247352|SUPERIORITY_OR_OTHER|||||||0.1877|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1877
70881378|NCT01480076|141247352|SUPERIORITY_OR_OTHER||least squares mean|4.1|STANDARD_ERROR_OF_MEAN|0.78|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881379|NCT01480076|141247352|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881380|NCT01480076|141247352|SUPERIORITY_OR_OTHER|||||||0.546|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5460
70881381|NCT01480076|141247352|SUPERIORITY_OR_OTHER||least squares mean|3.3|STANDARD_ERROR_OF_MEAN|0.79|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881382|NCT01480076|141247353|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881383|NCT01480076|141247353|SUPERIORITY_OR_OTHER|||||||0.9073|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9073
70881384|NCT01480076|141247353|SUPERIORITY_OR_OTHER||least squares mean|3.0|STANDARD_ERROR_OF_MEAN|0.89||0.0009|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0009
70962663|NCT04682977|141430117|SUPERIORITY||Mean difference (adjusted)|0.18|STANDARD_ERROR_OF_MEAN|0.65||0.78|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF - Control|||||0.78
70962664|NCT04682977|141430118|SUPERIORITY||Mean difference (adjusted)|-0.12|STANDARD_ERROR_OF_MEAN|0.53||0.83|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF - Control|||||0.83
70962665|NCT04682977|141430119|SUPERIORITY|||||||0.67||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.67
70881385|NCT01480076|141247353|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70962666|NCT04682977|141430120|SUPERIORITY|||||||0.77||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.77
70881386|NCT01480076|141247353|SUPERIORITY_OR_OTHER|||||||0.5542|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5542
70962667|NCT04682977|141430121|SUPERIORITY|||||||0.79||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.79
70881387|NCT01480076|141247353|SUPERIORITY_OR_OTHER||least squares mean|4.8|STANDARD_ERROR_OF_MEAN|0.99|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70962668|NCT04682977|141430122|SUPERIORITY|||||||0.44||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.44
70962669|NCT04682977|141430123|SUPERIORITY|||||||0.65||||||The threshold for statistical significance was p = 0.05|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r||||||0.65
70962670|NCT04682977|141430124|SUPERIORITY|||||||0.66||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.66
70881388|NCT01480076|141247353|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881389|NCT01480076|141247353|SUPERIORITY_OR_OTHER|||||||0.581|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5810
70881390|NCT01480076|141247353|SUPERIORITY_OR_OTHER||least squares mean|2.7|STANDARD_ERROR_OF_MEAN|1.08||0.014|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0140
70881391|NCT01480076|141247353|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881392|NCT01480076|141247353|SUPERIORITY_OR_OTHER|||||||0.4138|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4138
70881393|NCT01480076|141247353|SUPERIORITY_OR_OTHER||least squares mean|1.3|STANDARD_ERROR_OF_MEAN|1.19||0.274|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2740
70881394|NCT01480076|141247353|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881395|NCT01480076|141247353|SUPERIORITY_OR_OTHER|||||||0.6453|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6453
70881396|NCT01480076|141247353|SUPERIORITY_OR_OTHER||least squares mean|3.1|STANDARD_ERROR_OF_MEAN|1.18||0.009|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0090
70881397|NCT01480076|141247354|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881398|NCT01480076|141247354|SUPERIORITY_OR_OTHER|||||||0.2475|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2475
70881399|NCT01480076|141247354|SUPERIORITY_OR_OTHER||least squares mean|-8.2|STANDARD_ERROR_OF_MEAN|1.66|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881400|NCT01480076|141247354|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881401|NCT01480076|141247354|SUPERIORITY_OR_OTHER|||||||0.2422|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2422
70881402|NCT01480076|141247354|SUPERIORITY_OR_OTHER||least squares mean|-10.9|STANDARD_ERROR_OF_MEAN|1.72|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881403|NCT01480076|141247354|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881404|NCT01480076|141247354|SUPERIORITY_OR_OTHER|||||||0.1262|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1262
70962671|NCT04682977|141430125|SUPERIORITY|||||||0.81||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.81
70962672|NCT04682977|141430126|SUPERIORITY|||||||0.89||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.89
70962673|NCT01621230|141430127|OTHER|The median (first and third quartile) lengths of the second stage of labor were estimated at 28min (15, 58) in women without epidural analgesia. Assuming a one-third increase in the length of the second stage to 37min due to epidural bupivacaine, a sample size of 155 per arm (310 total) was required for 80% power to detect such a difference using a two-sided Wilcoxon rank sum test.||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
70962674|NCT01621230|141430130|OTHER|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||.55
70962675|NCT01621230|141430131|OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||.57
70962676|NCT01284062|141430170|SUPERIORITY_OR_OTHER||Least squares (LS) mean|0.41|||||TWO_SIDED|80.0|0.225|0.766|||||LS mean and confidence interval (CI) were based on back log-transformation of those from the analysis of covariance (ANCOVA) model.|||0.766|0.225|
70962677|NCT01284062|141430170|SUPERIORITY_OR_OTHER||LS mean|0.29|||||TWO_SIDED|80.0|0.187|0.446|||||LS mean and CI were based on back log-transformation of those from the ANCOVA model.|||0.446|0.187|
70962678|NCT01284062|141430170|SUPERIORITY_OR_OTHER||LS mean|0.79|||||TWO_SIDED|80.0|0.517|1.203|||||LS mean and CI were based on back log-transformation of those from the ANCOVA model.|||1.203|0.517|
70962679|NCT01284062|141430170|SUPERIORITY_OR_OTHER||LS mean|1.24|||||TWO_SIDED|80.0|0.794|1.949|||||LS mean and CI were based on back log-transformation of those from the ANCOVA model.|||1.949|0.794|
70962680|NCT01284062|141430170|SUPERIORITY_OR_OTHER||LS mean ratio|0.7||||0.532|TWO_SIDED|80.0|0.329|1.472|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||1.472|0.329|0.5320
70962681|NCT01284062|141430170|SUPERIORITY_OR_OTHER||LS mean ratio|1.9||||0.27|TWO_SIDED|80.0|0.9|4.013|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||4.013|0.900|0.2700
70962682|NCT01284062|141430170|SUPERIORITY_OR_OTHER||LS mean ratio|3.0||||0.0666|TWO_SIDED|80.0|1.403|6.409|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||6.409|1.403|0.0666
70962683|NCT01284062|141430177|SUPERIORITY_OR_OTHER||LS mean|0.7|||||TWO_SIDED|80.0|0.466|1.048||||||Week 2: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.048|0.466|
70962684|NCT01284062|141430177|SUPERIORITY_OR_OTHER||LS mean|0.81|||||TWO_SIDED|80.0|0.552|1.185||||||Week 2: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.185|0.552|
70962685|NCT01284062|141430177|SUPERIORITY_OR_OTHER||LS mean|0.71|||||TWO_SIDED|80.0|0.488|1.027||||||Week 2: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.027|0.488|
70962686|NCT01284062|141430177|SUPERIORITY_OR_OTHER||LS mean|0.77|||||TWO_SIDED|80.0|0.5|1.195||||||Week 2: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.195|0.500|
70962687|NCT01284062|141430177|SUPERIORITY_OR_OTHER||LS mean|0.92|||||TWO_SIDED|80.0|0.631|1.328||||||Week 4: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.328|0.631|
70962688|NCT01284062|141430177|SUPERIORITY_OR_OTHER||LS mean|0.47|||||TWO_SIDED|80.0|0.339|0.655||||||Week 4: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||0.655|0.339|
70962689|NCT01284062|141430177|SUPERIORITY_OR_OTHER||LS mean|0.92|||||TWO_SIDED|80.0|0.669|1.269||||||Week 4: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.269|0.669|
70962690|NCT01284062|141430177|SUPERIORITY_OR_OTHER||LS mean|0.55|||||TWO_SIDED|80.0|0.388|0.779||||||Week 4: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||0.779|0.388|
70962691|NCT01284062|141430177|SUPERIORITY_OR_OTHER||LS mean|0.78|||||TWO_SIDED|80.0|0.454|1.331||||||Week 8: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.331|0.454|
70962692|NCT01284062|141430177|SUPERIORITY_OR_OTHER||LS mean|0.36|||||TWO_SIDED|80.0|0.236|0.553||||||Week 8: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||0.553|0.236|
70962693|NCT01284062|141430177|SUPERIORITY_OR_OTHER||LS mean|1.14|||||TWO_SIDED|80.0|0.757|1.722||||||Week 8: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.722|0.757|
70962694|NCT01284062|141430177|SUPERIORITY_OR_OTHER||LS mean|0.52|||||TWO_SIDED|80.0|0.338|0.788||||||Week 8: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||0.788|0.338|
70962695|NCT01284062|141430177|SUPERIORITY_OR_OTHER||LS mean|0.64|||||TWO_SIDED|80.0|0.374|1.084||||||Week 12: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.084|0.374|
70962696|NCT01284062|141430177|SUPERIORITY_OR_OTHER||LS mean|0.19|||||TWO_SIDED|80.0|0.122|0.297||||||Week 12: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||0.297|0.122|
70962697|NCT01284062|141430177|SUPERIORITY_OR_OTHER||LS mean|0.96|||||TWO_SIDED|80.0|0.623|1.465||||||Week 12: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.465|0.623|
70881405|NCT01480076|141247354|SUPERIORITY_OR_OTHER||least squares mean|-7.6|STANDARD_ERROR_OF_MEAN|1.9|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881406|NCT01480076|141247354|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881407|NCT01480076|141247354|SUPERIORITY_OR_OTHER|||||||0.8858|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8858
70962698|NCT01284062|141430177|SUPERIORITY_OR_OTHER||LS mean|0.67|||||TWO_SIDED|80.0|0.411|1.076||||||Week 12: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.076|0.411|
70881408|NCT01480076|141247354|SUPERIORITY_OR_OTHER||least squares mean|-8.6|STANDARD_ERROR_OF_MEAN|2.12|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881409|NCT01480076|141247354|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881410|NCT01480076|141247354|SUPERIORITY_OR_OTHER|||||||0.2111|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2111
70881411|NCT01480076|141247354|SUPERIORITY_OR_OTHER||least squares mean|-5.8|STANDARD_ERROR_OF_MEAN|2.16||0.0072|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0072
70881412|NCT01480076|141247355|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881413|NCT01480076|141247355|SUPERIORITY_OR_OTHER|||||||0.5577|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5577
70881414|NCT01480076|141247355|SUPERIORITY_OR_OTHER||least squares mean|-6.7|STANDARD_ERROR_OF_MEAN|1.64|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881415|NCT01480076|141247355|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881416|NCT01480076|141247355|SUPERIORITY_OR_OTHER|||||||0.9365|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9365
70962699|NCT01284062|141430177|SUPERIORITY_OR_OTHER||LS mean ratio|1.16||||0.7352|TWO_SIDED|80.0|0.663|2.021|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 2: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||2.021|0.663|0.7352
70962700|NCT01284062|141430177|SUPERIORITY_OR_OTHER||LS mean ratio|1.01||||0.9754|TWO_SIDED|80.0|0.586|1.753|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 2: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||1.753|0.586|0.9754
70962701|NCT01284062|141430177|SUPERIORITY_OR_OTHER||LS mean ratio|1.11||||0.8277|TWO_SIDED|80.0|0.609|2.008|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 2: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||2.008|0.609|0.8277
70962702|NCT01284062|141430177|SUPERIORITY_OR_OTHER||LS mean ratio|0.51||||0.0885|TWO_SIDED|80.0|0.313|0.846|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 4: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||0.846|0.313|0.0885
70962703|NCT01284062|141430177|SUPERIORITY_OR_OTHER||LS mean ratio|1.01||||0.9856|TWO_SIDED|80.0|0.617|1.644|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 4: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||1.644|0.617|0.9856
70962704|NCT01284062|141430177|SUPERIORITY_OR_OTHER||LS mean ratio|0.6||||0.1996|TWO_SIDED|80.0|0.361|1.0|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 4: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||1.000|0.361|0.1996
70962705|NCT01284062|141430177|SUPERIORITY_OR_OTHER||LS mean ratio|0.46||||0.1553|TWO_SIDED|80.0|0.233|0.926|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 8: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||0.926|0.233|0.1553
70962706|NCT01284062|141430177|SUPERIORITY_OR_OTHER||LS mean ratio|1.47||||0.4633|TWO_SIDED|80.0|0.748|2.882|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 8: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||2.882|0.748|0.4633
70962707|NCT01284062|141430177|SUPERIORITY_OR_OTHER||LS mean ratio|0.66||||0.4409|TWO_SIDED|80.0|0.335|1.316|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 8: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||1.316|0.335|0.4409
70962708|NCT01284062|141430177|SUPERIORITY_OR_OTHER||LS mean ratio|0.3||||0.0283|TWO_SIDED|80.0|0.15|0.598|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 12: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||0.598|0.150|0.0283
70962709|NCT01284062|141430177|SUPERIORITY_OR_OTHER||LS mean ratio|1.5||||0.4434|TWO_SIDED|80.0|0.758|2.97|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 12: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||2.970|0.758|0.4434
70962710|NCT01284062|141430177|SUPERIORITY_OR_OTHER||LS mean ratio|1.04||||0.9372|TWO_SIDED|80.0|0.51|2.141|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 12: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||2.141|0.510|0.9372
70962711|NCT01284062|141430182|SUPERIORITY_OR_OTHER||percentage of participants|41.67|||||TWO_SIDED|80.0|25.53|59.81|||||CI was assessed by Wilson score method.|||59.81|25.53|
70962712|NCT01284062|141430182|SUPERIORITY_OR_OTHER||percentage of participants|60.0|||||TWO_SIDED|80.0|43.59|74.43|||||CI was assessed by Wilson score method.|||74.43|43.59|
70962713|NCT01284062|141430182|SUPERIORITY_OR_OTHER||percentage of participants|50.0|||||TWO_SIDED|80.0|34.74|65.26|||||CI was assessed by Wilson score method.|||65.26|34.74|
70962714|NCT01284062|141430182|SUPERIORITY_OR_OTHER||percentage of participants|15.38|||||TWO_SIDED|80.0|6.58|31.96|||||CI was assessed by Wilson score method.|||31.96|6.58|
70962715|NCT01284062|141430182|SUPERIORITY_OR_OTHER||percent difference|18.33||||0.4495|TWO_SIDED|80.0|-6.13|39.98|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher's exact test.||39.98|-6.13|0.4495
70962716|NCT01284062|141430182|SUPERIORITY_OR_OTHER||percent difference|8.33||||0.7177|TWO_SIDED|80.0|-15.37|30.54|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher's exact test.||30.54|-15.37|0.7177
70962717|NCT01284062|141430182|SUPERIORITY_OR_OTHER||percent difference|-26.28||||0.2016|TWO_SIDED|80.0|-46.45|-3.15|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher's exact test.||-3.15|-46.45|0.2016
70962718|NCT01284062|141430183|SUPERIORITY_OR_OTHER||percentage of participants|16.67|||||TWO_SIDED|80.0|7.14|34.22|||||CI was assessed by Wilson score method.|||34.22|7.14|
70962719|NCT01284062|141430183|SUPERIORITY_OR_OTHER||percentage of participants|33.33|||||TWO_SIDED|80.0|20.08|49.88|||||CI was assessed by Wilson score method.|||49.88|20.08|
70962720|NCT01284062|141430183|SUPERIORITY_OR_OTHER||percentage of participants|18.75|||||TWO_SIDED|80.0|9.4|33.92|||||CI was assessed by Wilson score method.|||33.92|9.40|
70962721|NCT01284062|141430183|SUPERIORITY_OR_OTHER||percentage of participants|0.0|||||TWO_SIDED|80.0|0.0|11.22|||||CI was assessed by Wilson score method.|||11.22|0.00|
70962722|NCT01284062|141430183|SUPERIORITY_OR_OTHER||percent difference|16.67||||0.4082|TWO_SIDED|80.0|-5.33|35.76|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher's exact test.||35.76|-5.33|0.4082
70962723|NCT01284062|141430183|SUPERIORITY_OR_OTHER||percent difference|2.08||||1|TWO_SIDED|80.0|-17.8|19.99|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher's exact test.||19.99|-17.80|1.0000
70962724|NCT01284062|141430183|SUPERIORITY_OR_OTHER||percent difference|-16.67||||0.22|TWO_SIDED|80.0|-34.22|-1.95|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher's exact test.||-1.95|-34.22|0.2200
70962725|NCT01284062|141430184|SUPERIORITY_OR_OTHER||LS mean|-1.32|||||TWO_SIDED|80.0|-2.332|-0.3||||||||-0.300|-2.332|
70962726|NCT01284062|141430184|SUPERIORITY_OR_OTHER||LS mean|-2.28|||||TWO_SIDED|80.0|-3.19|-1.374||||||||-1.374|-3.190|
70962727|NCT01284062|141430184|SUPERIORITY_OR_OTHER||LS mean|-2.3|||||TWO_SIDED|80.0|-3.178|-1.419||||||||-1.419|-3.178|
70962728|NCT01284062|141430184|SUPERIORITY_OR_OTHER||LS mean|-0.79|||||TWO_SIDED|80.0|-1.761|0.19||||||||0.190|-1.761|
70962729|NCT01284062|141430184|SUPERIORITY_OR_OTHER||LS mean difference|-0.97||||0.3639|TWO_SIDED|80.0|-2.335|0.403|||ANCOVA|||P-value was analyzed from ANCOVA model with terms for treatment group and baseline.||0.403|-2.335|0.3639
70962730|NCT01284062|141430184|SUPERIORITY_OR_OTHER||LS mean difference|-0.98||||0.3446|TWO_SIDED|80.0|-2.32|0.355|||ANCOVA|||P-value was analyzed from ANCOVA model with terms for treatment group and baseline.||0.355|-2.320|0.3446
70962731|NCT01284062|141430184|SUPERIORITY_OR_OTHER||LS mean difference|0.53||||0.6285|TWO_SIDED|80.0|-0.884|1.945|||ANCOVA|||P-value was analyzed from ANCOVA model with terms for treatment group and baseline.||1.945|-0.884|0.6285
70962732|NCT00809523|141430228|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|||Data were analyzed at the follow up timepoint (4 weeks) to test for differences between the experimental groups.||||0.007
70962733|NCT00809523|141430229|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||t-test, 2 sided|||||||0.014
70962734|NCT04721821|141430241|SUPERIORITY||Odds Ratio (OR)|1.09|||||TWO_SIDED|95.0|0.82|1.44||||||||1.44|0.82|
70962735|NCT04721821|141430242|SUPERIORITY||Odds Ratio (OR)|0.72|||||TWO_SIDED|95.0|0.44|1.16||||||||1.16|0.44|
70962736|NCT04721821|141430243|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.73|1.27||||||||1.27|0.73|
70962737|NCT04721821|141430244|SUPERIORITY||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.79|1.88||||||||1.88|0.79|
70962738|NCT04721821|141430245|SUPERIORITY||Odds Ratio (OR)|1.14|||||TWO_SIDED|95.0|0.79|1.67||||||||1.67|0.79|
70962739|NCT04721821|141430246|SUPERIORITY||Odds Ratio (OR)|1.29|||||TWO_SIDED|95.0|0.94|1.76||||||||1.76|0.94|
70962740|NCT04721821|141430247|SUPERIORITY||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.7|1.89||||||||1.89|0.70|
70962741|NCT04721821|141430248|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.69|1.32||||||||1.32|0.69|
70962742|NCT04721821|141430249|SUPERIORITY||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.81|2.16||||||||2.16|0.81|
70962743|NCT04721821|141430250|SUPERIORITY||Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|0.81|1.87||||||||1.87|0.81|
70962744|NCT04721821|141430251|SUPERIORITY||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.8|1.66||||||Month 6 follow-up visit analysis||1.66|0.80|
70962745|NCT04721821|141430251|SUPERIORITY||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.75|1.65||||||Month 12 follow-up visit analysis||1.65|0.75|
70962746|NCT04721821|141430252|SUPERIORITY||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.57|1.99||||||Month 6 follow-up visit analysis||1.99|0.57|
70962747|NCT04721821|141430252|SUPERIORITY||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.49|1.75||||||Month 12 follow-up visit analysis||1.75|0.49|
70962748|NCT04721821|141430253|SUPERIORITY||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.79|1.58||||||Month 6 follow-up visit analysis||1.58|0.79|
70962749|NCT04721821|141430253|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.6|1.35||||||Month 12 follow-up visit analysis||1.35|0.60|
70962750|NCT04721821|141430254|SUPERIORITY||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.77|2.29||||||Month 6 follow-up visit analysis||2.29|0.77|
70962751|NCT04721821|141430254|SUPERIORITY||Odds Ratio (OR)|1.49|||||TWO_SIDED|95.0|0.82|2.71||||||Month 12 follow-up visit analysis||2.71|0.82|
70962752|NCT04721821|141430255|SUPERIORITY||Odds Ratio (OR)|1.35|||||TWO_SIDED|95.0|0.81|2.24||||||Month 6 follow-up visit analysis||2.24|0.81|
70962753|NCT04721821|141430255|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.5|1.62||||||Month 12 follow-up visit analysis||1.62|0.50|
70962754|NCT04721821|141430256|SUPERIORITY||Mean Difference (Net)|0.21|||||TWO_SIDED|95.0|-0.88|1.31||||||Month 6 follow-up visit analysis||1.31|-0.88|
70962755|NCT04721821|141430256|SUPERIORITY||Mean Difference (Net)|-1.5|||||TWO_SIDED|95.0|-2.73|-0.27||||||Month 12 follow-up visit analysis||-0.27|-2.73|
70962756|NCT04721821|141430257|SUPERIORITY||Median Difference (Net)|0.39|||||TWO_SIDED|95.0|-1.24|2.02||||||Month 6 follow-up visit analysis||2.02|-1.24|
70962757|NCT04721821|141430257|SUPERIORITY||Median Difference (Net)|0.96|||||TWO_SIDED|95.0|-0.92|2.84||||||Month 12 follow-up visit analysis||2.84|-0.92|
70962758|NCT04721821|141430258|SUPERIORITY||Mean Difference (Net)|-0.56|||||TWO_SIDED|95.0|-1.68|0.56||||||Month 6 follow-up visit analysis||0.56|-1.68|
70962759|NCT04721821|141430258|SUPERIORITY||Mean Difference (Net)|0.74|||||TWO_SIDED|95.0|-0.51|1.99||||||Month 12 follow-up visit analysis||1.99|-0.51|
70962760|NCT04721821|141430259|SUPERIORITY||Mean Difference (Net)|-1.11|||||TWO_SIDED|95.0|-2.66|0.45||||||Month 6 follow-up visit analysis||0.45|-2.66|
70962761|NCT04721821|141430259|SUPERIORITY||Mean Difference (Net)|-1.73|||||TWO_SIDED|95.0|-3.52|0.05||||||Month 12 follow-up visit analysis||0.05|-3.52|
70962762|NCT04721821|141430260|SUPERIORITY||Mean Difference (Net)|-0.93|||||TWO_SIDED|95.0|-2.3|0.44||||||Month 6 follow-up visit analysis||0.44|-2.30|
70881417|NCT01480076|141247355|SUPERIORITY_OR_OTHER||least squares mean|-9.4|STANDARD_ERROR_OF_MEAN|1.82|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881418|NCT01480076|141247355|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881419|NCT01480076|141247355|SUPERIORITY_OR_OTHER|||||||0.2008|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2008
70962763|NCT04721821|141430260|SUPERIORITY||Mean Difference (Net)|-0.99|||||TWO_SIDED|95.0|-2.6|0.62||||||Month 12 follow-up visit analysis||0.62|-2.60|
70962764|NCT04721821|141430261|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.8|1.35||||||Month 6 follow-up visit analysis: mACR 20||1.35|0.80|
70962765|NCT04721821|141430261|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.86|1.67||||||Month 6 follow-up visit analysis: mACR 50||1.67|0.86|
70962766|NCT04721821|141430261|SUPERIORITY||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.57|1.54||||||Month 6 follow-up visit analysis: mACR 70||1.54|0.57|
70962767|NCT04721821|141430261|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.77|1.41||||||Month 12 follow-up visit analysis: mACR 20||1.41|0.77|
70962768|NCT04721821|141430261|SUPERIORITY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.89|1.95||||||Month 12 follow-up visit analysis: mACR 50||1.95|0.89|
70962769|NCT04721821|141430261|SUPERIORITY||Odds Ratio (OR)|1.49|||||TWO_SIDED|95.0|0.85|2.6||||||Month 12 follow-up visit analysis: mACR 70||2.60|0.85|
70962770|NCT04721821|141430262|SUPERIORITY||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.59|1.34||||||Month 6 follow-up visit analysis: mACR 20||1.34|0.59|
70962771|NCT04721821|141430262|SUPERIORITY||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.39|1.15||||||Month 6 follow-up visit analysis: mACR 50||1.15|0.39|
70962772|NCT04721821|141430262|SUPERIORITY||Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.34|1.83||||||Month 6 follow-up visit analysis: mACR 70||1.83|0.34|
70962773|NCT04721821|141430262|SUPERIORITY||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.56|1.42||||||Month 12 follow-up visit analysis: mACR 20||1.42|0.56|
70962774|NCT04721821|141430262|SUPERIORITY||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.46|1.8||||||Month 12 follow-up visit analysis: mACR 50||1.80|0.46|
70962775|NCT04721821|141430262|SUPERIORITY||Odds Ratio (OR)|0.54|||||TWO_SIDED|95.0|0.19|1.48||||||Month 12 follow-up visit analysis: mACR 70||1.48|0.19|
70962776|NCT04721821|141430263|SUPERIORITY||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.86|1.45||||||Month 6 follow-up visit analysis: mACR 20||1.45|0.86|
70962777|NCT04721821|141430263|SUPERIORITY||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.67|1.26||||||Month 6 follow-up visit analysis: mACR 50||1.26|0.67|
70962778|NCT04721821|141430263|SUPERIORITY||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.44|1.09||||||Month 6 follow-up visit analysis: mACR 70||1.09|0.44|
70962779|NCT04721821|141430263|SUPERIORITY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.74|1.38||||||Month 12 follow-up visit analysis: mACR 20||1.38|0.74|
70962780|NCT04721821|141430263|SUPERIORITY||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.69|1.52||||||Month 12 follow-up visit analysis: mACR 50||1.52|0.69|
70962781|NCT04721821|141430263|SUPERIORITY||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.46|1.33||||||Month 12 follow-up visit analysis: mACR 70||1.33|0.46|
70962782|NCT04721821|141430264|SUPERIORITY||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.78|1.77||||||Month 6 follow-up visit analysis: mACR 20||1.77|0.78|
70962783|NCT04721821|141430264|SUPERIORITY||Odds Ratio (OR)|1.17|||||TWO_SIDED|95.0|0.71|1.95||||||Month 6 follow-up visit analysis: mACR 50||1.95|0.71|
70962784|NCT04721821|141430264|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.45|2.39||||||Month 6 follow-up visit analysis: mACR 70||2.39|0.45|
70962785|NCT04721821|141430264|SUPERIORITY||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.5|1.4||||||Month 12 follow-up visit analysis: mACR 20||1.40|0.50|
70962786|NCT04721821|141430264|SUPERIORITY||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.49|1.83||||||Month 12 follow-up visit analysis: mACR 50||1.83|0.49|
70962787|NCT04721821|141430264|SUPERIORITY||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.33|1.95||||||Month 12 follow-up visit analysis: mACR 70||1.95|0.33|
70962788|NCT04721821|141430265|SUPERIORITY||Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.76|1.49||||||Month 6 follow-up visit analysis: mACR 20||1.49|0.76|
70962789|NCT04721821|141430265|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.55|1.37||||||Month 6 follow-up visit analysis: mACR 50||1.37|0.55|
70962790|NCT04721821|141430265|SUPERIORITY||Odds Ratio (OR)|0.62|||||TWO_SIDED|95.0|0.32|1.2||||||Month 6 follow-up visit analysis: mACR 70||1.20|0.32|
70962791|NCT04721821|141430265|SUPERIORITY||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.59|1.3||||||Month 12 follow-up visit analysis: mACR 20||1.30|0.59|
70962792|NCT04721821|141430265|SUPERIORITY||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.65|1.86||||||Month 12 follow-up visit analysis: mACR 50||1.86|0.65|
70962793|NCT04721821|141430265|SUPERIORITY||Odds Ratio (OR)|1.43||||||95.0|0.62|3.28||||||Month 12 follow-up visit analysis: mACR 70||3.28|0.62|
70962794|NCT04721821|141430266|SUPERIORITY||Odds Ratio (OR)|1.42|||||TWO_SIDED|95.0|0.94|2.15||||||Month 6 follow-up visit analysis||2.15|0.94|
70962795|NCT04721821|141430266|SUPERIORITY||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.68|1.84||||||Month 12 follow-up visit analysis||1.84|0.68|
70962796|NCT04721821|141430267|SUPERIORITY||Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.41|1.67||||||Month 6 follow-up visit analysis||1.67|0.41|
70962797|NCT04721821|141430267|SUPERIORITY||Odds Ratio (OR)|1.38|||||TWO_SIDED|95.0|0.62|3.07||||||Month 12 follow-up visit analysis||3.07|0.62|
70962798|NCT04721821|141430268|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.66|1.52||||||Month 6 follow-up visit analysis||1.52|0.66|
70962799|NCT04721821|141430268|SUPERIORITY||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.64|1.74||||||Month 12 follow-up visit analysis||1.74|0.64|
70962800|NCT04721821|141430269|SUPERIORITY||Odds Ratio (OR)|1.54|||||TWO_SIDED|95.0|0.8|2.94||||||Month 6 follow-up visit analysis||2.94|0.80|
70962801|NCT04721821|141430269|SUPERIORITY||Odds Ratio (OR)|1.72|||||TWO_SIDED|95.0|0.76|3.87||||||Month 12 follow-up visit analysis||3.87|0.76|
70962802|NCT04721821|141430270|SUPERIORITY||Odds Ratio (OR)|1.29|||||TWO_SIDED|95.0|0.73|2.27||||||Month 6 follow-up visit analysis||2.27|0.73|
70962803|NCT04721821|141430270|SUPERIORITY||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.63|2.23||||||Month 12 follow-up visit analysis||2.23|0.63|
70962804|NCT04721821|141430271|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.06|0.04||||||Month 6 follow-up visit analysis||0.04|-0.06|
70962805|NCT04721821|141430271|SUPERIORITY||Mean Difference (Final Values)|0.04|||||TWO_SIDED|95.0|-0.01|0.09||||||Month 12 follow-up visit analysis||0.09|-0.01|
70962806|NCT04721821|141430272|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.08|0.06||||||Month 6 follow-up visit analysis||0.06|-0.08|
70962807|NCT04721821|141430272|SUPERIORITY||Median Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.11|0.05||||||Month 12 follow-up visit analysis||0.05|-0.11|
70962808|NCT04721821|141430273|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.07|0.03||||||Month 6 follow-up visit analysis||0.03|-0.07|
70962809|NCT04721821|141430273|SUPERIORITY||Odds Ratio (OR)|0.01|||||TWO_SIDED|95.0|-0.05|0.07||||||Month 12 follow-up visit analysis||0.07|-0.05|
70962810|NCT04721821|141430274|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.06|0.07||||||Month 6 follow-up visit analysis||0.07|-0.06|
70962811|NCT04721821|141430274|SUPERIORITY||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.12|0.06||||||Month 12 follow-up visit analysis||0.06|-0.12|
70962812|NCT04721821|141430275|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.09|0.04||||||Month 6 follow-up visit analysis||0.04|-0.09|
70962813|NCT04721821|141430275|SUPERIORITY||Odds Ratio (OR)|0.02|||||TWO_SIDED|95.0|-0.06|0.09||||||Month 12 follow-up visit analysis||0.09|-0.06|
70962814|NCT04721821|141430276|SUPERIORITY||Odds Ratio (OR)|1.14|||||TWO_SIDED|95.0|0.9|1.45||||||Month 6 follow-up visit analysis||1.45|0.90|
70962815|NCT04721821|141430276|SUPERIORITY||Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.54|0.94||||||Month 12 follow-up visit analysis||0.94|0.54|
70962816|NCT04721821|141430277|SUPERIORITY||Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.53|1.11||||||Month 6 follow-up visit analysis||1.11|0.53|
70962817|NCT04721821|141430277|SUPERIORITY||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.72|1.61||||||Month 12 follow-up visit analysis||1.61|0.72|
70962818|NCT04721821|141430278|SUPERIORITY||Odds Ratio (OR)|0.94|||||TWO_SIDED|95.0|0.73|1.21||||||Month 6 follow-up visit analysis||1.21|0.73|
70962819|NCT04721821|141430278|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.77|1.39||||||Month 12 follow-up visit analysis||1.39|0.77|
70962820|NCT04721821|141430279|SUPERIORITY||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.64|1.32||||||Month 6 follow-up visit analysis||1.32|0.64|
70962821|NCT04721821|141430279|SUPERIORITY||Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.69|1.64||||||Month 12 follow-up visit analysis||1.64|0.69|
70962822|NCT04721821|141430280|SUPERIORITY||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.84|1.59||||||Month 6 follow-up visit analysis||1.59|0.84|
70962823|NCT04721821|141430280|SUPERIORITY||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.65|1.32||||||Month 12 follow-up visit analysis||1.32|0.65|
70962824|NCT04721821|141430281|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.03|0.04||||||Month 6 follow-up visit analysis||0.04|-0.03|
70962825|NCT04721821|141430281|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.04|0.05||||||Month 12 follow-up visit analysis||0.05|-0.04|
70962826|NCT04721821|141430282|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.05|0.05||||||Month 6 follow-up visit analysis||0.05|-0.05|
70962827|NCT04721821|141430282|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.07|0.06||||||Month 12 follow-up visit analysis||0.06|-0.07|
70962828|NCT04721821|141430283|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.06|0.02||||||Month 6 follow-up visit analysis||0.02|-0.06|
70962829|NCT04721821|141430283|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.04|0.04||||||Month 12 follow-up visit analysis||0.04|-0.04|
70962830|NCT04721821|141430284|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.06|0.04||||||Month 6 follow-up visit analysis||0.04|-0.06|
70962831|NCT04721821|141430284|SUPERIORITY||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.1|0.03||||||Month 12 follow-up visit analysis||0.03|-0.10|
70962832|NCT04721821|141430285|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.05|0.04||||||Month 6 follow-up visit analysis||0.04|-0.05|
70881420|NCT01480076|141247355|SUPERIORITY_OR_OTHER||least squares mean|-5.1|STANDARD_ERROR_OF_MEAN|1.98||0.0102|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0102
70962833|NCT04721821|141430285|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.06|0.06||||||Month 12 follow-up visit analysis||0.06|-0.06|
70962834|NCT04721821|141430286|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-2.65|2.45||||||Month 6 follow-up visit analysis||2.45|-2.65|
70962835|NCT04721821|141430286|SUPERIORITY||Mean Difference (Final Values)|0.26|||||TWO_SIDED|95.0|-2.59|3.11||||||Month 12 follow-up visit analysis||3.11|-2.59|
70962836|NCT04721821|141430287|SUPERIORITY||Mean Difference (Final Values)|0.83|||||TWO_SIDED|95.0|-2.71|4.38||||||Month 6 follow-up visit analysis||4.38|-2.71|
70962837|NCT04721821|141430287|SUPERIORITY||Mean Difference (Final Values)|-1.09|||||TWO_SIDED|95.0|-5.12|2.95||||||Month 12 follow-up visit analysis||2.95|-5.12|
70962838|NCT04721821|141430288|SUPERIORITY||Mean Difference (Final Values)|-1.25|||||TWO_SIDED|95.0|-3.94|1.45||||||Month 6 follow-up visit analysis||1.45|-3.94|
70962839|NCT04721821|141430288|SUPERIORITY||Mean Difference (Final Values)|-0.59|||||TWO_SIDED|95.0|-3.61|2.42||||||Month 12 follow-up visit analysis||2.42|-3.61|
70962840|NCT04721821|141430289|SUPERIORITY||Mean Difference (Final Values)|-0.67|||||TWO_SIDED|95.0|-4.39|3.05||||||Month 6 follow-up visit analysis||3.05|-4.39|
70962841|NCT04721821|141430289|SUPERIORITY||Mean Difference (Final Values)|-4.84|||||TWO_SIDED|95.0|-9.19|-0.48||||||Month 12 follow-up visit analysis||-0.48|-9.19|
70962842|NCT04721821|141430290|SUPERIORITY||Mean Difference (Final Values)|-0.39|||||TWO_SIDED|95.0|-3.59|2.82||||||Month 6 follow-up visit analysis||2.82|-3.59|
70962843|NCT04721821|141430290|SUPERIORITY||Mean Difference (Final Values)|0.76|||||TWO_SIDED|95.0|-2.97|4.49||||||Month 12 follow-up visit analysis||4.49|-2.97|
70962844|NCT04721821|141430291|SUPERIORITY||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.73|1.34||||||Month 6 follow-up visit analysis||1.34|0.73|
70962845|NCT04721821|141430291|SUPERIORITY||Odds Ratio (OR)|0.94|||||TWO_SIDED|95.0|0.66|1.34||||||Month 12 follow-up visit analysis||1.34|0.66|
70962846|NCT04721821|141430292|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.62|1.73||||||Month 6 follow-up visit analysis||1.73|0.62|
70962847|NCT04721821|141430292|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.5|1.6||||||Month 12 follow-up visit analysis||1.60|0.50|
70962848|NCT04721821|141430293|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.64|1.19||||||Month 6 follow-up visit analysis||1.19|0.64|
70962849|NCT04721821|141430293|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.6|1.26||||||Month 12 follow-up visit analysis||1.26|0.60|
70962850|NCT04721821|141430294|SUPERIORITY||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.55|1.46||||||Month 6 follow-up visit analysis||1.46|0.55|
70962851|NCT04721821|141430294|SUPERIORITY||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.47|1.51||||||Month 12 follow-up visit analysis||1.51|0.47|
70962852|NCT04721821|141430295|SUPERIORITY||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.6|1.38||||||Month 6 follow-up visit analysis||1.38|0.60|
70962853|NCT04721821|141430295|SUPERIORITY||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.56|1.5||||||Month 12 follow-up visit analysis||1.50|0.56|
70962854|NCT04721821|141430296|SUPERIORITY||Mean Difference (Final Values)|1.71|||||TWO_SIDED|95.0|-0.69|4.11||||||Month 6 follow-up visit analysis||4.11|-0.69|
70962855|NCT04721821|141430296|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-2.79|2.77||||||Month 12 follow-up visit analysis||2.77|-2.79|
70962856|NCT04721821|141430297|SUPERIORITY||Mean Difference (Final Values)|-1.71|||||TWO_SIDED|95.0|-5.02|1.6||||||Month 6 follow-up visit analysis||1.60|-5.02|
70962857|NCT04721821|141430297|SUPERIORITY||Mean Difference (Final Values)|1.06|||||TWO_SIDED|95.0|-2.85|4.96||||||Month 12 follow-up visit analysis||4.96|-2.85|
70962858|NCT04721821|141430298|SUPERIORITY||Mean Difference (Final Values)|-1.15|||||TWO_SIDED|95.0|-3.75|1.45||||||Month 6 follow-up visit analysis||1.45|-3.75|
70962859|NCT04721821|141430298|SUPERIORITY||Median Difference (Final Values)|-0.53|||||TWO_SIDED|95.0|-3.54|2.47||||||Month 12 follow-up visit analysis||2.47|-3.54|
70962860|NCT04721821|141430299|SUPERIORITY||Mean Difference (Final Values)|1.19|||||TWO_SIDED|95.0|-2.36|4.73||||||Month 6 follow-up visit analysis||4.73|-2.36|
70962861|NCT04721821|141430299|SUPERIORITY||Mean Difference (Final Values)|-3.15|||||TWO_SIDED|95.0|-7.36|1.07||||||Month 12 follow-up visit analysis||1.07|-7.36|
70962862|NCT04721821|141430300|SUPERIORITY||Mean Difference (Final Values)|2.37|||||TWO_SIDED|95.0|-0.66|5.41||||||Month 6 follow-up visit analysis||5.41|-0.66|
70962863|NCT04721821|141430300|SUPERIORITY||Mean Difference (Final Values)|1.01|||||TWO_SIDED|95.0|-2.69|4.71||||||Month 12 follow-up visit analysis||4.71|-2.69|
70962864|NCT04721821|141430301|SUPERIORITY||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.16|0.4||||||Month 6 follow-up visit analysis||0.40|-0.16|
70962865|NCT04721821|141430301|SUPERIORITY||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.21|0.45||||||Month 12 follow-up visit analysis||0.45|-0.21|
70962866|NCT04721821|141430302|SUPERIORITY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.4|0.43||||||Month 6 follow-up visit analysis||0.43|-0.40|
70962867|NCT04721821|141430302|SUPERIORITY||Mean Difference (Final Values)|-0.23|||||TWO_SIDED|95.0|-0.74|0.29||||||Month 12 follow-up visit analysis||0.29|-0.74|
70962868|NCT04721821|141430303|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.51|0.1||||||Month 6 follow-up visit analysis||0.10|-0.51|
70962869|NCT04721821|141430303|SUPERIORITY||Mean Difference (Final Values)|-0.05|||||TWO_SIDED|95.0|-0.42|0.31||||||Month 12 follow-up visit analysis||0.31|-0.42|
70962870|NCT04721821|141430304|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.34|0.32||||||Month 6 follow-up visit analysis||0.32|-0.34|
70962871|NCT04721821|141430304|SUPERIORITY||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-0.69|0.31||||||Month 12 follow-up visit analysis||0.31|-0.69|
70962872|NCT04721821|141430305|SUPERIORITY||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.37|0.32||||||Month 6 follow-up visit analysis||0.32|-0.37|
70962873|NCT04721821|141430305|SUPERIORITY||Mean Difference (Final Values)|0.15|||||TWO_SIDED|95.0|-0.3|0.59||||||Month 12 follow-up visit analysis||0.59|-0.30|
70881421|NCT01480076|141247355|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70962874|NCT02876835|141430330|NON_INFERIORITY|Non-inferiority was achieved if the upper limit of the two-sided 95% CI for the hazard ratio was below the pre-specified non-inferiority margin of 1.25.|Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.89|1.19|||||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.19|0.89|
70881422|NCT01480076|141247355|SUPERIORITY_OR_OTHER|||||||0.7134|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7134
70962875|NCT02876835|141430331|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was greater than -0.75 g/dL.|Least square (LS) mean difference|0.08|||||TWO_SIDED|95.0|0.03|0.13||||||||0.13|0.03|
70962876|NCT02876835|141430332|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.670884|TWO_SIDED|95.0|0.89|1.19||The p-value was compared against 0.008333 based on the Holm-Bonferonni adjustment.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.19|0.89|0.670884
70962877|NCT02876835|141430333|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.800813|TWO_SIDED|95.0|0.93|1.22||The p-value was compared against 0.012500 based on the Holm-Bonferonni adjustment.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.22|0.93|0.800813
70962878|NCT02876835|141430334|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.886195|TWO_SIDED|95.0|0.95|1.24||The p-value was compared against 0.025000 based on the Holm-Bonferonni adjustment.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.24|0.95|0.886195
70962879|NCT02876835|141430335|SUPERIORITY||Subdistribution hazard ratio|0.98||||0.36947|TWO_SIDED|95.0|0.84|1.13|||Wald test||Subdistribution hazard ratio was estimated using Fine and Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use, and region as covariates.|||1.13|0.84|0.369470
70881423|NCT01480076|141247355|SUPERIORITY_OR_OTHER||least squares mean|-6.0|STANDARD_ERROR_OF_MEAN|2.2||0.0066|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0066
70881424|NCT01480076|141247355|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70962880|NCT02876835|141430336|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.6197|TWO_SIDED|95.0|0.87|1.2|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.20|0.87|0.6197
70881425|NCT01480076|141247355|SUPERIORITY_OR_OTHER|||||||0.8202|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8202
70881426|NCT01480076|141247355|SUPERIORITY_OR_OTHER||least squares mean|-6.4|STANDARD_ERROR_OF_MEAN|2.28||0.0049|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0049
70962881|NCT02876835|141430337|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.8976|TWO_SIDED|95.0|0.91|1.58|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.58|0.91|0.8976
70962882|NCT02876835|141430338|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.6581|TWO_SIDED|95.0|0.8|1.4|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.40|0.80|0.6581
70962883|NCT02876835|141430339|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.894|TWO_SIDED|95.0|0.85|2.07|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||2.07|0.85|0.8940
70962884|NCT02876835|141430340|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.9422|TWO_SIDED|95.0|0.98|1.23|||Chi-squared||Overall HR is presented using Model 1. Model 1 assumed a common treatment effect, regardless of number of events experienced. HR was estimated using a Prentice, Williams and Peterson(PWP) model, with treatment, dialysis type and region as covariates.|||1.23|0.98|0.9422
70962885|NCT02876835|141430340|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.8862|TWO_SIDED|95.0|0.95|1.24|||Chi-squared||First Event Hazard ratio is presented using Model 2. Model 2 assumed treatment effect differs by number of events experienced. Hazard Ratio (HR) was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.24|0.95|0.8862
70881427|NCT01480076|141247356|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70962886|NCT02876835|141430340|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.6789|TWO_SIDED|95.0|0.82|1.39|||Chi-squared||Second Event Hazard ratio is presented using Model 2. Model 2 assumed treatment effect differs by number of events experienced. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.39|0.82|0.6789
70962887|NCT02876835|141430340|SUPERIORITY||Hazard Ratio (HR)|1.37||||0.9016|TWO_SIDED|95.0|0.85|2.19|||Chi-squared||Third Event Hazard ratio is presented using Model 2. Model 2 assumed treatment effect differs by number of events experienced. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||2.19|0.85|0.9016
70962888|NCT02876835|141430340|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.8862|TWO_SIDED|95.0|0.95|1.24|||Chi-squared||First Event Hazard ratio is presented using Model 3. Model 3 assumed treatment effect for first event differs from a common effect for subsequent events. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.24|0.95|0.8862
70962889|NCT02876835|141430340|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.8989|TWO_SIDED|95.0|0.92|1.46|||Chi-squared||Subsequent Event Hazard ratio is presented using Model 3. Model 3 assumed treatment effect for first event differs from a common effect for subsequent events. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.46|0.92|0.8989
70962890|NCT02876835|141430341|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.7673|TWO_SIDED|95.0|0.88|1.33|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.33|0.88|0.7673
70962891|NCT02876835|141430342|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.8601|TWO_SIDED|95.0|0.96|1.15|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.15|0.96|0.8601
70962892|NCT02876835|141430343|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.6207|TWO_SIDED|95.0|0.86|1.22|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.22|0.86|0.6207
70962893|NCT02876835|141430344|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.9393|TWO_SIDED|95.0|0.97|1.26|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.26|0.97|0.9393
70962894|NCT02876835|141430345|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.9412|TWO_SIDED|95.0|0.95|1.56|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.56|0.95|0.9412
70962895|NCT02876835|141430346|SUPERIORITY||Hazard Ratio (HR)|1.27||||0.8994|TWO_SIDED|95.0|0.88|1.84|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.84|0.88|0.8994
70962896|NCT02876835|141430347|SUPERIORITY||Subdistribution hazard ratio|0.92||||0.2073|TWO_SIDED|95.0|0.75|1.13|||Wald test||Subdistribution hazard ratio was estimated using Fine \& Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use, and region as covariates.|||1.13|0.75|0.2073
70962897|NCT02876835|141430348|SUPERIORITY||Subdistribution hazard ratio|1.0||||0.5068|TWO_SIDED|95.0|0.84|1.19|||Wald test||Subdistribution hazard ratio was estimated using Fine \& Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use, and region as covariates.|||1.19|0.84|0.5068
70962898|NCT02876835|141430349|SUPERIORITY||Subdistribution hazard ratio|0.88||||0.3285|TWO_SIDED|95.0|0.51|1.54|||Wald test||Subdistribution hazard ratio was estimated using Fine \& Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use, and region as covariates.|||1.54|0.51|0.3285
70962899|NCT02876835|141430350|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was greater than the pre-specified non-inferiority margin of -0.75 g/dL.|LS mean difference|0.03|||||TWO_SIDED|95.0|-0.05|0.11||||||||0.11|-0.05|
70962900|NCT02876835|141430351|SUPERIORITY||Difference in response rate|8.3|||<|0.0001|TWO_SIDED|95.0|5.2|11.4|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel (CMH) test adjusted for current ESA use and region was used to compare the number of responders between the treatment groups.|||11.4|5.2|<0.0001
70962901|NCT02876835|141430352|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% confidence interval for the treatment difference was greater than non-inferiority margin of -15%.|Mean Difference (Final Values)|4.57|||||TWO_SIDED|95.0|2.04|7.11|||||Hodges-Lehmann estimate of the treatment difference (daprodustat-darbepoetin alfa) and associated two-sided asymptotic 95% CI is presented.|||7.11|2.04|
70962902|NCT02876835|141430353|SUPERIORITY||Probability|0.55|||<|0.0001|TWO_SIDED|95.0|0.53|0.57|||van Elteren test||Mann-Whitney estimate (Probability) of the treatment effect has been presented.|||0.57|0.53|<0.0001
70962903|NCT02876835|141430354|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% confidence interval for the treatment difference was greater than non-inferiority margin of -15%.|Median Difference (Final Values)|3.94|||||TWO_SIDED|95.0|1.9|5.91|||||Hodges-Lehmann estimate of the treatment difference (daprodustat-darbepoetin alfa) and associated two-sided asymptotic 95% CI is presented.|||5.91|1.90|
70962904|NCT02876835|141430355|SUPERIORITY||Probability|0.54|||<|0.0001|TWO_SIDED|95.0|0.52|0.56|||van Elteren test||Mann-Whitney estimate (Probability) of the treatment effect has been presented.|||0.56|0.52|<0.0001
70962905|NCT02876835|141430356|SUPERIORITY||LS mean difference|0.56||||0.7916|TWO_SIDED|95.0|-0.79|1.9|||MMRM||The difference in change from Baseline in SBP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||1.90|-0.79|0.7916
70962906|NCT02876835|141430356|SUPERIORITY||LS mean difference|0.65||||0.9581|TWO_SIDED|95.0|-0.09|1.38|||MMRM||The difference in change from Baseline in DBP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||1.38|-0.09|0.9581
70962907|NCT02876835|141430356|SUPERIORITY||LS mean difference|0.6||||0.9241|TWO_SIDED|95.0|-0.22|1.43|||MMRM||The difference in change from Baseline in MAP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||1.43|-0.22|0.9241
70962908|NCT02876835|141430357|SUPERIORITY||LS mean difference|-0.08||||0.442|TWO_SIDED|95.0|-1.18|1.02|||ANCOVA||For SBP: Treatment group comparisons were based on an ANCOVA model with terms for treatment group, current ESA use at randomization, region and Baseline value.|||1.02|-1.18|0.4420
70962909|NCT02876835|141430357|SUPERIORITY||LS mean difference|0.11||||0.6369|TWO_SIDED|95.0|-0.52|0.75|||ANCOVA||For DBP: Treatment group comparisons were based on an ANCOVA model with terms for treatment group, current ESA use at randomization, region and Baseline value.|||0.75|-0.52|0.6369
70881428|NCT01480076|141247356|SUPERIORITY_OR_OTHER|||||||0.1324|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1324
70881429|NCT01480076|141247356|SUPERIORITY_OR_OTHER||least squares mean|-2.3|STANDARD_ERROR_OF_MEAN|0.56|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70962910|NCT02876835|141430357|SUPERIORITY||LS mean difference|0.04||||0.549|TWO_SIDED|95.0|-0.65|0.74|||ANCOVA||For MAP: Treatment group comparisons were based on an ANCOVA model with terms for treatment group, current ESA use at randomization, region and Baseline value.|||0.74|-0.65|0.5490
70881430|NCT01480076|141247356|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881431|NCT01480076|141247356|SUPERIORITY_OR_OTHER|||||||0.4759|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4759
70881432|NCT01480076|141247356|SUPERIORITY_OR_OTHER||least squares mean|-1.9|STANDARD_ERROR_OF_MEAN|0.59||0.0016|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0016
70962911|NCT02876835|141430358|SUPERIORITY||Ratio of exacerbation rate|0.88||||0.0074|TWO_SIDED|95.0|0.79|0.98|||Negative binomial model||Ratio of model estimated exacerbation rates and CIs estimated using negative binomial model with treatment,current ESA use at randomization and region as covariates and logarithm of time on treatment as offset variable for treatment group comparison.|||0.98|0.79|0.0074
70962912|NCT02876835|141430360|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0113|TWO_SIDED|95.0|0.42|0.94|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model adjusted for treatment group, current ESA use and region.|||0.94|0.42|0.0113
70881433|NCT01480076|141247356|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error||||<0.0001
70881434|NCT01480076|141247356|SUPERIORITY_OR_OTHER|||||||0.2489|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2489
70881435|NCT01480076|141247356|SUPERIORITY_OR_OTHER||least squares mean|-2.2|STANDARD_ERROR_OF_MEAN|0.71||0.0017|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0017
70962913|NCT02876835|141430361|SUPERIORITY||LS mean difference|-0.36||||0.932|TWO_SIDED|95.0|-0.83|0.11|||MMRM||Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time,current ESA use at randomization, region,Baseline value and Baseline value by time and treatment by time interactions|||0.11|-0.83|0.9320
70881436|NCT01480076|141247356|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881437|NCT01480076|141247356|SUPERIORITY_OR_OTHER|||||||0.0126|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0126
70881438|NCT01480076|141247356|SUPERIORITY_OR_OTHER||least squares mean|-3.1|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881439|NCT01480076|141247356|SUPERIORITY_OR_OTHER|||||||0.0033|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0033
70881440|NCT01480076|141247356|SUPERIORITY_OR_OTHER|||||||0.1758|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1758
70962914|NCT02876835|141430361|SUPERIORITY||LS mean difference|-0.11||||0.6761|TWO_SIDED|95.0|-0.59|0.36|||MMRM||Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions|||0.36|-0.59|0.6761
70962915|NCT02876835|141430361|SUPERIORITY||LS mean difference|0.12||||0.3335|TWO_SIDED|95.0|-0.43|0.67|||MMRM||Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions|||0.67|-0.43|0.3335
70962916|NCT02876835|141430361|SUPERIORITY||LS mean difference|-0.2||||0.7423|TWO_SIDED|95.0|-0.81|0.41|||MMRM||Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions|||0.41|-0.81|0.7423
70962917|NCT02876835|141430362|SUPERIORITY||LS mean difference|-0.29||||0.8268|TWO_SIDED|95.0|-0.9|0.32|||MMRM||Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions.|||0.32|-0.90|0.8268
70962918|NCT02876835|141430362|SUPERIORITY||LS mean difference|-0.15||||0.6851|TWO_SIDED|95.0|-0.77|0.47|||MMRM||Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions|||0.47|-0.77|0.6851
70962919|NCT02876835|141430362|SUPERIORITY||LS mean difference|-0.33||||0.8316|TWO_SIDED|95.0|-1.01|0.35|||MMRM||Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions|||0.35|-1.01|0.8316
70962920|NCT02876835|141430362|SUPERIORITY||LS mean difference|-0.35||||0.8032|TWO_SIDED|95.0|-1.16|0.46|||MMRM||Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions|||0.46|-1.16|0.8032
70962921|NCT02876835|141430363|SUPERIORITY||LS mean difference|-0.34||||0.8562|TWO_SIDED|95.0|-0.95|0.28|||MMRM||B pain,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.28|-0.95|0.8562
70962922|NCT02876835|141430363|SUPERIORITY||LS mean difference|-0.15||||0.6849|TWO_SIDED|95.0|-0.77|0.47|||MMRM||B pain,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.47|-0.77|0.6849
70962923|NCT02876835|141430363|SUPERIORITY||LS mean difference|-0.49||||0.9074|TWO_SIDED|95.0|-1.22|0.24|||MMRM||B pain,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.24|-1.22|0.9074
70962924|NCT02876835|141430363|SUPERIORITY||LS mean difference|-0.47||||0.8765|TWO_SIDED|95.0|-1.26|0.32|||MMRM||B pain,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.32|-1.26|0.8765
70962925|NCT02876835|141430363|SUPERIORITY||LS mean difference|-0.08||||0.6252|TWO_SIDED|95.0|-0.56|0.4|||MMRM||GH,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.40|-0.56|0.6252
70962926|NCT02876835|141430363|SUPERIORITY||LS mean difference|-0.2||||0.7852|TWO_SIDED|95.0|-0.68|0.29|||MMRM||GH,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.29|-0.68|0.7852
70962927|NCT02876835|141430363|SUPERIORITY||LS mean difference|0.1||||0.3614|TWO_SIDED|95.0|-0.46|0.66|||MMRM||GH,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.66|-0.46|0.3614
70962928|NCT02876835|141430363|SUPERIORITY||LS mean difference|-0.08||||0.5991|TWO_SIDED|95.0|-0.7|0.54|||MMRM||GH,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.54|-0.70|0.5991
70962929|NCT02876835|141430363|SUPERIORITY||LS mean difference|-0.31||||0.8526|TWO_SIDED|95.0|-0.88|0.27|||MMRM||MH,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.27|-0.88|0.8526
70962930|NCT02876835|141430363|SUPERIORITY||LS mean difference|0.02||||0.4673|TWO_SIDED|95.0|-0.56|0.61|||MMRM||MH,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.61|-0.56|0.4673
70881441|NCT01480076|141247356|SUPERIORITY_OR_OTHER||least squares mean|-1.9|STANDARD_ERROR_OF_MEAN|0.84||0.0246|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0246
70881442|NCT01480076|141247357|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881443|NCT01480076|141247357|SUPERIORITY_OR_OTHER|||||||0.0111|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0111
70881444|NCT01480076|141247357|SUPERIORITY_OR_OTHER||least squares mean|11.1|STANDARD_ERROR_OF_MEAN|1.61|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder Versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881445|NCT01480076|141247357|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881446|NCT01480076|141247357|SUPERIORITY_OR_OTHER|||||||0.097|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0970
70881447|NCT01480076|141247357|SUPERIORITY_OR_OTHER||least squares mean|11.1|STANDARD_ERROR_OF_MEAN|1.82|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder Versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881448|NCT01480076|141247357|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881449|NCT01480076|141247357|SUPERIORITY_OR_OTHER|||||||0.0789|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0789
70962931|NCT02876835|141430363|SUPERIORITY||LS mean difference|-0.31||||0.8262|TWO_SIDED|95.0|-0.95|0.33|||MMRM||MH,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.33|-0.95|0.8262
70881450|NCT01480076|141247357|SUPERIORITY_OR_OTHER||least squares mean|9.7|STANDARD_ERROR_OF_MEAN|2.0|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 6, Responder Versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70962932|NCT02876835|141430363|SUPERIORITY||LS mean difference|-0.25||||0.738|TWO_SIDED|95.0|-1.0|0.51|||MMRM||MH,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.51|-1.00|0.7380
70881451|NCT01480076|141247357|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881452|NCT01480076|141247357|SUPERIORITY_OR_OTHER|||||||0.0284|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0284
70962933|NCT02876835|141430363|SUPERIORITY||LS mean difference|-0.09||||0.5997|TWO_SIDED|95.0|-0.8|0.62|||MMRM||RE,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.62|-0.80|0.5997
70881453|NCT01480076|141247357|SUPERIORITY_OR_OTHER||least squares mean|11.2|STANDARD_ERROR_OF_MEAN|2.16|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 9, Responder Versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881454|NCT01480076|141247357|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881455|NCT01480076|141247357|SUPERIORITY_OR_OTHER|||||||0.0108|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0108
70962934|NCT02876835|141430363|SUPERIORITY||LS mean difference|-0.26||||0.7649|TWO_SIDED|95.0|-0.98|0.45|||MMRM||RE,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.45|-0.98|0.7649
70881456|NCT01480076|141247357|SUPERIORITY_OR_OTHER||least squares mean|12.3|STANDARD_ERROR_OF_MEAN|2.29|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 12, Responder Versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881457|NCT01480076|141247358|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881458|NCT01480076|141247358|SUPERIORITY_OR_OTHER|||||||0.8392|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8392
70881459|NCT01480076|141247358|SUPERIORITY_OR_OTHER||least squares mean|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.0162|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0162
70881460|NCT01480076|141247358|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881461|NCT01480076|141247358|SUPERIORITY_OR_OTHER|||||||0.6956|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6956
70962935|NCT02876835|141430363|SUPERIORITY||LS mean difference|-0.37||||0.8175|TWO_SIDED|95.0|-1.18|0.43|||MMRM||RE,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.43|-1.18|0.8175
70881462|NCT01480076|141247358|SUPERIORITY_OR_OTHER||least squares mean|0.06|STANDARD_ERROR_OF_MEAN|0.02||0.0042|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0042
70881463|NCT01480076|141247358|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881464|NCT01480076|141247358|SUPERIORITY_OR_OTHER|||||||0.7949|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7949
70962936|NCT02876835|141430363|SUPERIORITY||LS mean difference|-0.52||||0.8591|TWO_SIDED|95.0|-1.47|0.43|||MMRM||RE,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.43|-1.47|0.8591
70962937|NCT02876835|141430363|SUPERIORITY||LS mean difference|-0.5||||0.9588|TWO_SIDED|95.0|-1.06|0.06|||MMRM||RP,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.06|-1.06|0.9588
70962938|NCT02876835|141430363|SUPERIORITY||LS mean difference|-0.33||||0.8761|TWO_SIDED|95.0|-0.9|0.23|||MMRM||RP,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.23|-0.90|0.8761
70962939|NCT02876835|141430363|SUPERIORITY||LS mean difference|0.06||||0.4293|TWO_SIDED|95.0|-0.58|0.7|||MMRM||RP,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.70|-0.58|0.4293
70962940|NCT02876835|141430363|SUPERIORITY||LS mean difference|-0.19||||0.6983|TWO_SIDED|95.0|-0.92|0.53|||MMRM||RP,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.53|-0.92|0.6983
70962941|NCT02876835|141430363|SUPERIORITY||LS mean difference|-0.62||||0.9743|TWO_SIDED|95.0|-1.25|0.0|||MMRM||SF,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.00|-1.25|0.9743
70881465|NCT01480076|141247358|SUPERIORITY_OR_OTHER||least squares mean|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.0679|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0679
70881466|NCT01480076|141247358|SUPERIORITY_OR_OTHER|||||||0.0027|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0027
70881467|NCT01480076|141247358|SUPERIORITY_OR_OTHER|||||||0.8053|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8053
70881468|NCT01480076|141247358|SUPERIORITY_OR_OTHER||least squares mean|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.2638|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2638
70881469|NCT01480076|141247358|SUPERIORITY_OR_OTHER|||||||0.0007|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0007
70881470|NCT01480076|141247358|SUPERIORITY_OR_OTHER|||||||0.8502|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8502
70881471|NCT01480076|141247358|SUPERIORITY_OR_OTHER||least squares mean|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.0917|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0917
70881472|NCT01480076|141247359|SUPERIORITY_OR_OTHER|||||||0.1795|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1795
70881473|NCT01480076|141247359|SUPERIORITY_OR_OTHER|||||||0.0715|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0715
70881474|NCT01480076|141247359|SUPERIORITY_OR_OTHER||least squares mean|5.8|STANDARD_ERROR_OF_MEAN|4.6||0.2065|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2065
70881475|NCT01480076|141247359|SUPERIORITY_OR_OTHER|||||||0.1649|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1649
70881476|NCT01480076|141247359|SUPERIORITY_OR_OTHER|||||||0.4894|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4894
70881477|NCT01480076|141247359|SUPERIORITY_OR_OTHER||least squares mean|1.0|STANDARD_ERROR_OF_MEAN|5.89||0.8611|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8611
70881478|NCT01480076|141247359|SUPERIORITY_OR_OTHER|||||||0.0073|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0073
70881479|NCT01480076|141247359|SUPERIORITY_OR_OTHER|||||||0.1343|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1343
70881480|NCT01480076|141247359|SUPERIORITY_OR_OTHER||least squares mean|2.3|STANDARD_ERROR_OF_MEAN|5.09||0.6468|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6468
70881481|NCT01480076|141247359|SUPERIORITY_OR_OTHER|||||||0.6441|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6441
70881482|NCT01480076|141247359|SUPERIORITY_OR_OTHER|||||||0.2176|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2176
70881483|NCT01480076|141247359|SUPERIORITY_OR_OTHER||least squares mean|8.5|STANDARD_ERROR_OF_MEAN|7.91||0.2814|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2814
70881484|NCT01480076|141247359|SUPERIORITY_OR_OTHER|||||||0.7533|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7533
70881485|NCT01480076|141247359|SUPERIORITY_OR_OTHER|||||||0.0653|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0653
70881486|NCT01480076|141247359|SUPERIORITY_OR_OTHER||least squares mean|11.4|STANDARD_ERROR_OF_MEAN|6.65||0.0876|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0876
70881487|NCT01480076|141247360|SUPERIORITY_OR_OTHER|||||||0.0281|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0281
70962942|NCT02876835|141430363|SUPERIORITY||LS mean difference|-0.32||||0.8405|TWO_SIDED|95.0|-0.94|0.31|||MMRM||SF,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.31|-0.94|0.8405
70881488|NCT01480076|141247360|SUPERIORITY_OR_OTHER|||||||0.0654|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0654
70881489|NCT01480076|141247360|SUPERIORITY_OR_OTHER||least squares mean|4.3|STANDARD_ERROR_OF_MEAN|4.47||0.34|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3400
70962943|NCT02876835|141430363|SUPERIORITY||LS mean difference|-0.13||||0.6459|TWO_SIDED|95.0|-0.82|0.56|||MMRM||SF,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.56|-0.82|0.6459
70962944|NCT02876835|141430363|SUPERIORITY||LS mean difference|-0.38||||0.8272|TWO_SIDED|95.0|-1.17|0.41|||MMRM||SF,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.41|-1.17|0.8272
70881490|NCT01480076|141247360|SUPERIORITY_OR_OTHER|||||||0.0012|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0012
70881491|NCT01480076|141247360|SUPERIORITY_OR_OTHER|||||||0.749|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7490
70962945|NCT02876835|141430364|SUPERIORITY||LS mean difference|-0.56||||0.9786|TWO_SIDED|95.0|-1.09|-0.02|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and model adjusted Week 8 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||-0.02|-1.09|0.9786
70881492|NCT01480076|141247360|SUPERIORITY_OR_OTHER||least squares mean|-5.1|STANDARD_ERROR_OF_MEAN|5.53||0.3592|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3592
70881493|NCT01480076|141247360|SUPERIORITY_OR_OTHER|||||||0.0015|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0015
70881494|NCT01480076|141247360|SUPERIORITY_OR_OTHER|||||||0.2967|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2967
70881495|NCT01480076|141247360|SUPERIORITY_OR_OTHER||least squares mean|-0.9|STANDARD_ERROR_OF_MEAN|5.34||0.8735|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8735
70881496|NCT01480076|141247360|SUPERIORITY_OR_OTHER|||||||0.1696|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1696
70881497|NCT01480076|141247360|SUPERIORITY_OR_OTHER|||||||0.0089|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0089
70962946|NCT02876835|141430364|SUPERIORITY||LS mean difference|-0.12||||0.6642|TWO_SIDED|95.0|-0.68|0.44|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and model adjusted Week 12 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.44|-0.68|0.6642
70962947|NCT02876835|141430364|SUPERIORITY||LS mean difference|-0.1||||0.6261|TWO_SIDED|95.0|-0.72|0.52|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and model adjusted Week 28 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.52|-0.72|0.6261
70881498|NCT01480076|141247360|SUPERIORITY_OR_OTHER||least squares mean|14.9|STANDARD_ERROR_OF_MEAN|6.83||0.0297|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0297
70962948|NCT02876835|141430364|SUPERIORITY||LS mean difference|-0.49||||0.9161|TWO_SIDED|95.0|-1.19|0.21|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and model adjusted Week 52 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.21|-1.19|0.9161
70881499|NCT01480076|141247360|SUPERIORITY_OR_OTHER|||||||0.8806|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8806
70881500|NCT01480076|141247360|SUPERIORITY_OR_OTHER|||||||0.217|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2170
70881501|NCT01480076|141247360|SUPERIORITY_OR_OTHER||least squares mean|8.1|STANDARD_ERROR_OF_MEAN|6.86||0.2392|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2392
70881502|NCT01480076|141247361|SUPERIORITY_OR_OTHER|||||||0.0219|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0219
70881503|NCT01480076|141247361|SUPERIORITY_OR_OTHER|||||||0.1259|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1259
70881504|NCT01480076|141247361|SUPERIORITY_OR_OTHER||least squares mean|3.6|STANDARD_ERROR_OF_MEAN|5.68||0.5312|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5312
70962949|NCT02876835|141430365|SUPERIORITY||LS mean difference|-0.32||||0.8703|TWO_SIDED|95.0|-0.88|0.24|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and model adjusted Week 8 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.24|-0.88|0.8703
70881505|NCT01480076|141247361|SUPERIORITY_OR_OTHER|||||||0.0022|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0022
70962950|NCT02876835|141430365|SUPERIORITY||LS mean difference|0.13||||0.3167|TWO_SIDED|95.0|-0.41|0.67|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and model adjusted Week 12 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.67|-0.41|0.3167
70962951|NCT02876835|141430365|SUPERIORITY||LS mean difference|0.15||||0.3155|TWO_SIDED|95.0|-0.47|0.78|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and model adjusted Week 28 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.78|-0.47|0.3155
70962952|NCT02876835|141430365|SUPERIORITY||LS mean difference|-0.32||||0.8069|TWO_SIDED|95.0|-1.06|0.41|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and model adjusted Week 52 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.41|-1.06|0.8069
70962953|NCT02876835|141430366|SUPERIORITY||LS mean difference|-0.0234||||0.9724|TWO_SIDED|95.0|-0.0474|0.0005|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.0005|-0.0474|0.9724
70962954|NCT02876835|141430367|SUPERIORITY||LS mean difference|0.7||||0.2687|TWO_SIDED|95.0|-1.5|2.9|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.|||2.9|-1.5|0.2687
70881506|NCT01480076|141247361|SUPERIORITY_OR_OTHER|||||||0.4968|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4968
70881507|NCT01480076|141247361|SUPERIORITY_OR_OTHER||least squares mean|-3.2|STANDARD_ERROR_OF_MEAN|6.64||0.6283|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6283
70881508|NCT01480076|141247361|SUPERIORITY_OR_OTHER|||||||0.0016|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0016
70881509|NCT01480076|141247361|SUPERIORITY_OR_OTHER|||||||0.6631|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6631
70881510|NCT01480076|141247361|SUPERIORITY_OR_OTHER||least squares mean|-4.8|STANDARD_ERROR_OF_MEAN|6.77||0.477|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4770
70881511|NCT01480076|141247361|SUPERIORITY_OR_OTHER|||||||0.4027|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4027
70881512|NCT01480076|141247361|SUPERIORITY_OR_OTHER|||||||0.1077|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1077
70881513|NCT01480076|141247361|SUPERIORITY_OR_OTHER||least squares mean|13.5|STANDARD_ERROR_OF_MEAN|9.98||0.1781|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1781
70881514|NCT01480076|141247361|SUPERIORITY_OR_OTHER|||||||0.2422|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2422
70881515|NCT01480076|141247361|SUPERIORITY_OR_OTHER|||||||0.0994|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0994
70881516|NCT01480076|141247361|SUPERIORITY_OR_OTHER||least squares mean|8.8|STANDARD_ERROR_OF_MEAN|7.13||0.2194|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2194
70881517|NCT01480076|141247362|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881518|NCT01480076|141247362|SUPERIORITY_OR_OTHER|||||||0.086|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0860
70881519|NCT01480076|141247362|SUPERIORITY_OR_OTHER||least squares mean|-7.3|STANDARD_ERROR_OF_MEAN|2.2||0.001|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0010
70881520|NCT01480076|141247362|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881521|NCT01480076|141247362|SUPERIORITY_OR_OTHER|||||||0.2777|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2777
70962955|NCT02876835|141430368|SUPERIORITY||LS mean difference|-1.22||||0.978|TWO_SIDED|95.0|-2.4|-0.03|||MMRM||Tired/LE/Weak domain,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-0.03|-2.40|0.9780
70962956|NCT02876835|141430368|SUPERIORITY||LS mean difference|-0.97||||0.943|TWO_SIDED|95.0|-2.18|0.23|||MMRM||Tired/LE/Weak domain,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.23|-2.18|0.9430
70881522|NCT01480076|141247362|SUPERIORITY_OR_OTHER||least squares mean|-10.4|STANDARD_ERROR_OF_MEAN|2.76||0.0002|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0002
70881523|NCT01480076|141247362|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881524|NCT01480076|141247362|SUPERIORITY_OR_OTHER|||||||0.1078|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1078
70881525|NCT01480076|141247362|SUPERIORITY_OR_OTHER||least squares mean|-7.6|STANDARD_ERROR_OF_MEAN|2.87||0.0082|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0082
70881526|NCT01480076|141247362|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881527|NCT01480076|141247362|SUPERIORITY_OR_OTHER|||||||0.1838|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1838
70881528|NCT01480076|141247362|SUPERIORITY_OR_OTHER||least squares mean|-6.3|STANDARD_ERROR_OF_MEAN|3.02||0.0364|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0364
70881529|NCT01480076|141247362|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881530|NCT01480076|141247362|SUPERIORITY_OR_OTHER|||||||0.1714|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1714
70881531|NCT01480076|141247362|SUPERIORITY_OR_OTHER||least squares mean|-4.8|STANDARD_ERROR_OF_MEAN|3.14||0.1259|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1259
70881532|NCT01480076|141247363|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881533|NCT01480076|141247363|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881534|NCT01480076|141247363|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881535|NCT01480076|141247363|SUPERIORITY_OR_OTHER|||||||0.0004|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0004
70881536|NCT01480076|141247363|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881537|NCT01480076|141247363|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881538|NCT01480076|141247363|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881539|NCT01480076|141247363|SUPERIORITY_OR_OTHER|||||||0.0069|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0069
70881540|NCT01480076|141247363|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881541|NCT01480076|141247363|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881542|NCT01480076|141247363|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0001
70881543|NCT01480076|141247363|SUPERIORITY_OR_OTHER|||||||0.0006|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0006
70881544|NCT01480076|141247363|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881545|NCT01480076|141247363|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881546|NCT01480076|141247363|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881547|NCT01480076|141247363|SUPERIORITY_OR_OTHER|||||||0.004|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0040
70881548|NCT01480076|141247363|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881549|NCT01480076|141247363|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881550|NCT01480076|141247363|SUPERIORITY_OR_OTHER|||||||0.0047|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0047
70881551|NCT01480076|141247363|SUPERIORITY_OR_OTHER|||||||0.0118|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0118
70881552|NCT01480076|141247364|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881553|NCT01480076|141247364|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881554|NCT01480076|141247364|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881555|NCT01480076|141247364|SUPERIORITY_OR_OTHER|||||||0.1398|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1398
70881556|NCT01480076|141247364|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881557|NCT01480076|141247364|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881558|NCT01480076|141247364|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881559|NCT01480076|141247364|SUPERIORITY_OR_OTHER|||||||0.0935|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0935
70881560|NCT01480076|141247364|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881561|NCT01480076|141247364|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881562|NCT01480076|141247364|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881563|NCT01480076|141247364|SUPERIORITY_OR_OTHER|||||||0.076|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0760
70881564|NCT01480076|141247364|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881565|NCT01480076|141247364|SUPERIORITY_OR_OTHER|||||||0.0019|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0019
70962957|NCT02876835|141430368|SUPERIORITY||LS mean difference|-0.6||||0.8042|TWO_SIDED|95.0|-1.98|0.77|||MMRM||Tired/LE/Weak domain,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.77|-1.98|0.8042
70962958|NCT02876835|141430368|SUPERIORITY||LS mean difference|-1.57||||0.977|TWO_SIDED|95.0|-3.11|-0.03|||MMRM||Tired/LE/Weak domain,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-0.03|-3.11|0.9770
70962959|NCT02876835|141430368|SUPERIORITY||LS mean difference|-1.2||||0.9905|TWO_SIDED|95.0|-2.2|-0.2|||MMRM||CP/SOB,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-0.20|-2.20|0.9905
70881566|NCT01480076|141247364|SUPERIORITY_OR_OTHER|||||||0.0037|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0037
70881567|NCT01480076|141247364|SUPERIORITY_OR_OTHER|||||||0.2489|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2489
70881568|NCT01480076|141247364|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70962960|NCT02876835|141430368|SUPERIORITY||LS mean difference|-0.65||||0.8939|TWO_SIDED|95.0|-1.67|0.37|||LS mean difference||CP/SOB,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.37|-1.67|0.8939
70962961|NCT02876835|141430368|SUPERIORITY||LS mean difference|-0.52||||0.807|TWO_SIDED|95.0|-1.7|0.66|||MMRM||CP/SOB,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.66|-1.70|0.8070
70962962|NCT02876835|141430368|SUPERIORITY||LS mean difference|-1.18||||0.9615|TWO_SIDED|95.0|-2.49|0.13|||MMRM||CP/SOB,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.13|-2.49|0.9615
70962963|NCT02876835|141430368|SUPERIORITY||LS mean difference|-0.76||||0.9015|TWO_SIDED|95.0|-1.91|0.39|||MMRM||Cog domain,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.39|-1.91|0.9015
70962964|NCT02876835|141430368|SUPERIORITY||LS mean difference|-1.18||||0.9781|TWO_SIDED|95.0|-2.32|-0.03|||MMRM||Cog domain,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-0.03|-2.32|0.9781
70962965|NCT02876835|141430368|SUPERIORITY||LS mean difference|-0.77||||0.8778|TWO_SIDED|95.0|-2.07|0.53|||MMRM||Cog domain,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.53|-2.07|0.8778
70962966|NCT02876835|141430368|SUPERIORITY||LS mean difference|-1.65||||0.9864|TWO_SIDED|95.0|-3.11|-0.19|||MMRM||Cog domain,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-0.19|-3.11|0.9864
70962967|NCT02876835|141430368|SUPERIORITY||LS mean difference|-1.1||||0.9725|TWO_SIDED|95.0|-2.3|0.0|||MMRM||SOB, no activity,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.0|-2.3|0.9725
70962968|NCT02876835|141430368|SUPERIORITY||LS mean difference|-0.3||||0.7188|TWO_SIDED|95.0|-1.5|0.8|||MMRM||SOB, no activity,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.8|-1.5|0.7188
70962969|NCT02876835|141430368|SUPERIORITY||LS mean difference|-0.9||||0.8903|TWO_SIDED|95.0|-2.3|0.5|||MMRM||SOB, no activity,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.5|-2.3|0.8903
70962970|NCT02876835|141430368|SUPERIORITY||LS mean difference|0.0||||0.5011|TWO_SIDED|95.0|-1.6|1.6|||MMRM||SOB, no activity,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||1.6|-1.6|0.5011
70962971|NCT02876835|141430368|SUPERIORITY||LS mean difference|-1.1||||0.9716|TWO_SIDED|95.0|-2.2|0.0|||MMRM||S-SB,Resting, Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.0|-2.2|0.9716
70962972|NCT02876835|141430368|SUPERIORITY||LS mean difference|-0.3||||0.6908|TWO_SIDED|95.0|-1.4|0.9|||MMRM||S-SB,Resting, Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.9|-1.4|0.6908
70962973|NCT02876835|141430368|SUPERIORITY||LS mean difference|-0.5||||0.7462|TWO_SIDED|95.0|-1.8|0.9|||MMRM||S-SB,Resting, Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.9|-1.8|0.7462
70962974|NCT02876835|141430368|SUPERIORITY||LS mean difference|-1.5||||0.977|TWO_SIDED|95.0|-2.9|0.0|||MMRM||S-SB,Resting, Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.0|-2.9|0.9770
70881569|NCT01480076|141247364|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0001
70962975|NCT02876835|141430368|SUPERIORITY||LS mean difference|-1.4||||0.9471|TWO_SIDED|95.0|-3.2|0.3|||MMRM||Diff std for LT, Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.3|-3.2|0.9471
70962976|NCT02876835|141430368|SUPERIORITY||LS mean difference|-0.9||||0.833|TWO_SIDED|95.0|-2.6|0.9|||MMRM||Diff std for LT, Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.9|-2.6|0.8330
70962977|NCT02876835|141430368|SUPERIORITY||LS mean difference|-1.2||||0.8918|TWO_SIDED|95.0|-3.2|0.7|||MMRM||Diff std for LT, Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.7|-3.2|0.8918
70962978|NCT02876835|141430368|SUPERIORITY||LS mean difference|-3.2||||0.9986|TWO_SIDED|95.0|-5.4|-1.1|||MMRM||Diff std for LT, Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-1.1|-5.4|0.9986
70962979|NCT02876835|141430368|SUPERIORITY||LS mean difference|0.4||||0.3035|TWO_SIDED|95.0|-1.2|2.1|||MMRM||Diff sleep, Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||2.1|-1.2|0.3035
70962980|NCT02876835|141430368|SUPERIORITY||LS mean difference|-1.4||||0.9563|TWO_SIDED|95.0|-3.1|0.2|||MMRM||Diff sleep, Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.2|-3.1|0.9563
70962981|NCT02876835|141430368|SUPERIORITY||LS mean difference|-0.4||||0.6548|TWO_SIDED|95.0|-2.3|1.5|||MMRM||Diff sleep, Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||1.5|-2.3|0.6548
70962982|NCT02876835|141430368|SUPERIORITY||LS mean difference|-2.4||||0.9832|TWO_SIDED|95.0|-4.5|-0.2|||MMRM||Diff sleep, Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-0.2|-4.5|0.9832
70962983|NCT02876835|141430369|SUPERIORITY||LS mean difference|0.02||||0.6917|TWO_SIDED|95.0|-0.05|0.08|||MMRM||Week 8: Model was fitted from Baseline up to Week52 and model adjusted Week 8 data has been presented, with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.08|-0.05|0.6917
70962984|NCT02876835|141430369|SUPERIORITY||LS mean difference|0.05||||0.951|TWO_SIDED|95.0|-0.01|0.11|||MMRM||Week 12: Model was fitted from Baseline up to Week52 and model adjusted Week 12 data has been presented, with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.11|-0.01|0.9510
70962985|NCT02876835|141430369|SUPERIORITY||LS mean difference|-0.04||||0.1136|TWO_SIDED|95.0|-0.11|0.03|||MMRM||Week 28: Model was fitted from Baseline up to Week52 and model adjusted Week 28 data has been presented, with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.03|-0.11|0.1136
70962986|NCT02876835|141430369|SUPERIORITY||LS mean difference|0.05||||0.8859|TWO_SIDED|95.0|-0.03|0.13|||MMRM||Week 52: Model was fitted from Baseline up to Week52 and model adjusted Week 52 data has been presented, with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.13|-0.03|0.8859
70962987|NCT02876835|141430370|SUPERIORITY||LS mean difference|-0.2||||0.7716|TWO_SIDED|95.0|-0.74|0.33|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, current ESA use at randomization, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.33|-0.74|0.7716
70962988|NCT05090995|141430378|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
70962989|NCT05090995|141430379|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
70962990|NCT05090995|141430380|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
70962991|NCT05090995|141430381|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
70962992|NCT05090995|141430382|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||For baseline consequences||||<.0001
70962993|NCT05090995|141430382|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||For effects with time||||<.0001
70962994|NCT05090995|141430383|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
70962995|NCT05090995|141430384|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||Effect of baseline sleep scores||||<.0001
70962996|NCT05090995|141430384|OTHER|||||||0.04|||||||Mixed Models Analysis|||For effects with time||||0.04
70962997|NCT05090995|141430385|OTHER|||||||0.02|||||||Mixed Models Analysis|||For interaction between treatment group and time||||0.02
70962998|NCT05090995|141430385|OTHER|||||||0.02|||||||Mixed Models Analysis|||Main effects of sex||||0.02
70962999|NCT05090995|141430385|OTHER|||||||0.0007|||||||Mixed Models Analysis|||Main effects of type of day of the week (weekday vs. weekend)||||0.0007
70963000|NCT05090995|141430385|OTHER|||||||0.02|||||||Mixed Models Analysis|||||||0.02
70881570|NCT01480076|141247364|SUPERIORITY_OR_OTHER|||||||0.0052|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0052
70963001|NCT05090995|141430386|OTHER|||||||0.0001|||||||Mixed Models Analysis|||Main effect of day of the week.||||0.0001
70963002|NCT05090995|141430387|OTHER|||||||0.04|||||||Mixed Models Analysis|||For interaction between treatment condition and time||||0.04
70963003|NCT05090995|141430387|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||Main effects of sex||||<.0001
70963004|NCT05090995|141430387|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||Main effects of type of day of the week (weekday vs. weekend)||||<0.0001
70963005|NCT05090995|141430387|OTHER|||||||0.03|||||||Mixed Models Analysis|||||||0.03
70963006|NCT03049735|141430392|SUPERIORITY||Treatment difference|54.54|||<|0.0001|TWO_SIDED|95.0|44.3|64.78||P-value was stratified by baseline MBL volume (\< 225 mL or ≥ 225 mL) and geographic region (North America or Rest of World). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference is relugolix + E2/NETA minus placebo.|The primary efficacy analysis was the comparison of the relugolix + E2/NETA group with the placebo group with respect to responder rate.||64.78|44.3|<0.0001
70963007|NCT03049735|141430393|SUPERIORITY||Treatment difference|46.83|||<|0.0001|TWO_SIDED|95.0|37.31|56.35||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America or Rest of World). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference was relugolix plus E2/NETA minus placebo. 95% confidence interval (CI) for difference is based on the normal approximation.|||56.35|37.31|<0.0001
70963008|NCT03049735|141430394|SUPERIORITY||Treatment difference|-61.1|STANDARD_ERROR_OF_MEAN|6.32|<|0.0001|TWO_SIDED|95.0|-73.5|-48.6||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|Assessed at a 2-sided α = 0.05 significance. Treatment difference is relugolix plus E2/NETA minus placebo.||||-48.6|-73.5|<0.0001
70881571|NCT01480076|141247364|SUPERIORITY_OR_OTHER|||||||0.7714|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.7714
70963009|NCT03049735|141430395|SUPERIORITY||Treatment difference|28.26|||=|0.0377|TWO_SIDED|95.0|3.68|52.84||P-value is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference is relugolix plus E2/NETA minus placebo. 95% CI for difference is based on the normal approximation.|||52.84|3.68|= 0.0377
70963010|NCT03049735|141430396|SUPERIORITY||Treatment difference|33.0|||<|0.0001|TWO_SIDED|95.0|18.36|47.56||P-value is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference is relugolix plus E2/NETA minus placebo. 95% CI for difference is based on the normal approximation.|||47.56|18.36|<0.0001
70963011|NCT03049735|141430397|SUPERIORITY||Treatment difference|-12.1|STANDARD_ERROR_OF_MEAN|7.19||0.0921|TWO_SIDED|95.0|-26.3|2.0||Based on analysis of covariance model with treatment, randomization stratification factors, Baseline MBL volume, geographic region (North America, Rest of World), and Baseline values as covariate. Assessed at a 2-sided α = 0.05 significance level.|ANCOVA|||||2|-26.3|0.0921
70963012|NCT03049735|141430398|SUPERIORITY||Treatment difference|-15.1|STANDARD_ERROR_OF_MEAN|3.98||0.0002|TWO_SIDED|95.0|-23.0|-7.3||Based on analysis of covariance model with treatment, randomization stratification factors, Baseline MBL volume, geographic region (North America, Rest of World), and Baseline values as covariate. Assessed at a 2-sided α = 0.05 significance level.|ANCOVA|||||-7.3|-23|0.0002
70963013|NCT03049735|141430399|SUPERIORITY||Treatment difference|-28.9|STANDARD_ERROR_OF_MEAN|3.75|<|0.0001|TWO_SIDED|95.0|-36.3|-21.5||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|Assessed at a 2-sided α = 0.05 significance level. LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||-21.5|-36.3|<0.0001
70963014|NCT03049735|141430402|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
70963015|NCT03049735|141430407|SUPERIORITY||||||<|0.0001||||||P-value is based on Log-rank test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World) from the proportional hazard regression model comparing relugolix + E2/NETA with placebo.|Log Rank|||||||<0.0001
70963016|NCT03049735|141430408|SUPERIORITY||||||<|0.0001||||||P-value for testing difference between relugolix plus E2/NETA and placebo is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||<0.0001
70963017|NCT03049735|141430409|SUPERIORITY||||||<|0.0001||||||P-value is based on Log-rank test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World) from the proportional hazard regression model comparing relugolix plus E2/NETA with placebo.|Log Rank|||||||<0.0001
70963018|NCT03049735|141430410|SUPERIORITY||||||<|0.0001||||||P-value was based on Log-rank test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World) from the proportional hazard regression model comparing relugolix + E2/NETA with placebo.|Log Rank|||||||<0.0001
70881572|NCT01480076|141247365|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70963019|NCT03049735|141430411|SUPERIORITY|||||||0.0377||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL).|Cochran-Mantel-Haenszel|||||||0.0377
70963020|NCT03049735|141430412|SUPERIORITY|||||||0.0117||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||0.0117
70963021|NCT03049735|141430413|SUPERIORITY|||||||0.0084||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World). Lower limit of normal is Hgb \< 11.6 g/dL.|Cochran-Mantel-Haenszel|||||||0.0084
70963022|NCT03049735|141430414|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
70963023|NCT03049735|141430415|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
70963024|NCT03049735|141430416|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
70963025|NCT03049735|141430417|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
70963026|NCT03049735|141430418|SUPERIORITY||||||<|0.0001||||||P-value for testing difference between Relugolix plus E2/NETA and placebo is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||<0.0001
70963027|NCT03049735|141430419|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
70963028|NCT03049735|141430420|SUPERIORITY||||||<|0.0001||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||<0.0001
70881573|NCT01480076|141247365|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881574|NCT01480076|141247365|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70963029|NCT03049735|141430421|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
70963030|NCT03049735|141430422|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
70963031|NCT03049735|141430424|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
70963032|NCT03049735|141430431|SUPERIORITY|||||||0.0002||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL).|Cochran-Mantel-Haenszel|||||||0.0002
70963033|NCT03153111|141430436|SUPERIORITY||Geometric mean ratio|1.02||||0.7923|TWO_SIDED|90.0|0.88|1.19|||ANCOVA|||||1.19|0.88|0.7923
70963034|NCT03153111|141430437|SUPERIORITY||Least square mean difference|-3.5|STANDARD_ERROR_OF_MEAN|2.82||0.2172|TWO_SIDED|90.0|-8.17|1.17|||ANCOVA|||||1.17|-8.17|0.2172
70963035|NCT03153111|141430438|SUPERIORITY||Least square mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.3665|TWO_SIDED|90.0|-0.05|0.02|||ANCOVA|||||0.02|-0.05|0.3665
70963036|NCT03891524|141430468|OTHER|||||||0.0004|||||||MCP-mod analysis|||||||0.0004
70963037|NCT03891524|141430469|OTHER|||||||0.7188|||||||MCP-MOD analysis|||||||0.7188
70963038|NCT03040622|141430477|OTHER|||||||0.06|||||||ANOVA|||||||0.06
70963039|NCT03040622|141430478|OTHER|||||||0.009|||||||ANOVA|||||||0.009
70963040|NCT03040622|141430479|OTHER|||||||0.001|||||||ANOVA|||||||0.001
70963041|NCT00447382|141430493|SUPERIORITY_OR_OTHER_LEGACY||Treatment Ratio|1.04||||0.649||95.0|0.86|1.26|||ANOVA|Treatment, previous insulin detemir exposure and country as fixed effects and the baseline value as a covariate. (Log transformed data).|The treatment ratio calculated is the NN729-NN304 ratio for the change from baseline to Week 52. The 95% confidence interval for this ratio was also calculated.|"Null hypothesis:Treatment with detemir produced with the NN729 process result in a similar change in cross reacting antibody levels as the NN304 process. Alternative hypothesis: change in antibody levels differ after treatment with detemir produced by the two manufacturing processes.~The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA."||1.26|0.86|0.649
70963042|NCT00447382|141430495|SUPERIORITY_OR_OTHER_LEGACY||Estimated treatment difference|-0.03||||0.758||95.0|-0.21|0.15|||ANOVA|Adjustments: Treatment, previous insulin detemir exposure and country as fixed effects and the baseline value as covariate.|The estimated treatment difference calculated is the NN729-NN304 treatment difference for the change from baseline to Week 52. The 95% confidence interval for this difference was also calculated.|The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA.||0.15|-0.21|0.758
70963043|NCT00447382|141430496|SUPERIORITY_OR_OTHER_LEGACY||Estimated treatment difference|-0.1||||0.812||95.0|-0.89|0.7|||ANOVA|Adjustments: Treatment, previous insulin detemir exposure and country as fixed effects and the baseline value as covariate.|The estimated treatment difference calculated is the NN729-NN304 treatment difference for the change from baseline to Week 52. The 95% confidence interval for this difference was also calculated|The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA.||0.7|-0.89|0.812
70963044|NCT00447382|141430498|SUPERIORITY_OR_OTHER_LEGACY||Treatment Ratio|0.93||||0.15||95.0|0.84|1.03|||ANOVA|Adjustments:Treatment, previous insulin detemir exposure and country as fixed effects and the baseline value as a covariate. (Log transformed data)|The treatment ratio calculated is the NN729-NN304 ratio for the change from baseline to Week 52. The 95% confidence interval for this ratio was also calculated.|The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA. The analysis was based on an assumption of a log-normal distribution for antibody data and was thus built on log-transformed data.||1.03|0.84|0.15
70963045|NCT00447382|141430499|SUPERIORITY_OR_OTHER_LEGACY||Treatment Ratio|1.0||||0.966||95.0|0.87|1.15|||ANOVA|Adjustments: Treatment, previous insulin detemir exposure and country as fixed effects and the baseline value as a covariate. (Log transformed data)|The treatment ratio calculated is the NN729-NN304 ratio for the change from baseline to Week 52. The 95% confidence interval for this ratio was also calculated.|The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA. The analysis was based on an assumption of a log-normal distribution for antibody data and was thus built on log-transformed data.||1.15|0.87|0.966
70963046|NCT04091451|141430521|NON_INFERIORITY|The non-inferiority was to be demonstrated if the upper limit (UL) of the 95% confidence interval (CI) of the ratio of the incidence of HZ recurrence between HZ/su group and Placebo group was below (\<) 5.|Incidence Rate Ratio (IRR)|0.0|||||TWO_SIDED|95.0|0.0|0.46|||Poisson||IRR = incidence rate of HZ recurrence in HZ/su group divided by the incidence rate of HZ recurrence in Placebo group. Poisson method was used to adjust for differences in follow-up time across individuals.|To demonstrate the non-inferiority of HZ/su vaccine compared to placebo in terms of incidence of HZ recurrence from 30 days post-second vaccination (Month 3) until study end (duration of approximately 2 years to 4 years and 5 months).||0.46|0.00|
70963047|NCT04124614|141430535|SUPERIORITY|MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|Treatment Difference|-5.59||||0.0007|TWO_SIDED|95.0|-8.79|-2.38|||MMRM|||||-2.38|-8.79|0.0007
70963048|NCT04124614|141430536|SUPERIORITY|MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|Treatment Difference|-0.47||||0.0019|TWO_SIDED|95.0|-0.76|-0.17|||MMRM|||||-0.17|-0.76|0.0019
70963049|NCT04124614|141430537|SUPERIORITY|MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|Treatment Difference|-12.03||||0.0016|TWO_SIDED|95.0|-19.44|-4.62|||MMRM|||||-4.62|-19.44|0.0016
70963050|NCT03801902|141430600|OTHER||||||||||||||||||"If 0-1 of initial 6 evaluable patients on an arm have a safety event, then the regimen will be deemed safe and that arm will continue to the second part of the study to enroll 6 additional evaluable patients. However, if 2 or more of the 6 patients develop a safety event, then that arm is considered not safe and will not continue to second part. The probability of the treatment being judged to be too toxic when the true toxicity rate is ≥ 40% is at least 77%. If the true toxicity rate is ≤ 18%, then the probability that the treatment will be deemed to be safe is at least 70%.~If fewer than 4 of the total of 12 evaluable patients on an arm experience a safety event, then the treatment will be considered tolerable. With a cohort of 12 patients, the probability of the treatment being judged to be too toxic when the true toxicity rate is ≥ 40% at least 78%. If the true toxicity rate is ≤ 18%, the probability that the treatment will be deemed to be safe is 85%."|||
70963051|NCT03258554|141430607|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.8878|TWO_SIDED|95.0|0.84|2.12||One-sided significance level = 0.2|Log Rank||Reference arm = radiation therapy + cetuximab|Sixty-nine progression-free survival (PFS) events provides 0.80 power for a log-rank test with one-sided alpha of 0.20 to detect an improvement in PFS corresponding to a median of 2.35 years (RT+Durvalumab) compared to 1.53 years (RT+Cetuximab). A hazard ratio (RT+Durvalumab/RT+Cetuximab) ≤ 0.806 would indicate a rejection of the null hypothesis (no difference between the arms) and the study would continue to phase III; otherwise, the study would not continue to phase III.||2.12|0.84|0.8878
70963052|NCT03258554|141430608|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.8175|TWO_SIDED|95.0|0.74|2.28||One-side significance level = 0.025|Log Rank|||||2.28|0.74|0.8175
70963053|NCT03258554|141430609|SUPERIORITY||Hazard Ratio (HR)|1.71||||0.1001|TWO_SIDED|95.0|0.89|3.28||Two-sided significance level = 0.05|Log Rank||Reference level = RT+ Cetuximab|||3.28|0.89|0.1001
70963054|NCT03258554|141430610|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.5197|TWO_SIDED|95.0|0.32|1.77||Two-sided significance level = 0.05|Log Rank||Reference level = RT+ Cetuximab|||1.77|0.32|0.5197
70963055|NCT03258554|141430611|SUPERIORITY||Hazard Ratio (HR)|1.75||||0.3201|TWO_SIDED|95.0|0.57|5.38||Two-sided significance level = 0.05|Log Rank|||||5.38|0.57|0.3201
70963056|NCT03258554|141430612|SUPERIORITY|||||||1||||||Two-sided significance level = 0.05|Fisher Exact|||||||1.00
70963057|NCT03258554|141430613|SUPERIORITY|||||||0.0688||||||Two-side significance level = 0.05|Fisher Exact|||||||0.0688
70963058|NCT03258554|141430616|SUPERIORITY||Cox Proportional Hazard|1.11|||||TWO_SIDED|95.0|0.62|1.97|||||Reference arm = RT + Cetuximab|CPS ≥ 1||1.97|0.62|
70963059|NCT03258554|141430616|SUPERIORITY||Cox Proportional Hazard|1.64|||||TWO_SIDED|95.0|0.66|4.06|||||Reference arm = RT + Cetuximab|CPS = 0||4.06|0.66|
70963060|NCT03258554|141430616|SUPERIORITY|||||||0.41||||||Testing the interaction of treatment arm and PD-L1 expression (CPS ≥ 1, CPS = 0)|Regression, Cox|||Interaction||||0.41
70963061|NCT03258554|141430617|SUPERIORITY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.57|2.51|||||Reference arm = RT + cetuximab|p16-positive||2.51|0.57|
70963062|NCT03258554|141430617|SUPERIORITY||Hazard Ratio (HR)|1.55|||||TWO_SIDED|95.0|0.83|2.89|||||Reference arm = RT + cetuximab|p16-negative||2.89|0.83|
70963063|NCT03258554|141430617|SUPERIORITY|||||||0.61||||||Testing the interaction of treatment arm and p16 status (positive, negative)|Regression, Cox|||Interaction||||0.61
70963064|NCT01601847|141430631|SUPERIORITY||Risk Ratio (RR)|0.66||||0.02|TWO_SIDED|95.0|0.47|0.94|||Poisson|Poisson regression using GEE with robust variance estimation (e.g. Zou, American Journal Epidemiology, 2004)||||0.94|0.47|0.02
70963065|NCT01601847|141430631|SUPERIORITY||Odds Ratio (OR)|0.522||||0.0185|TWO_SIDED|95.0|0.304|0.897|||logistic regression with GEE|||||0.897|0.304|0.0185
70963066|NCT01601847|141430632|SUPERIORITY|||||||0.228|||||||Regression, Logistic|||For secondary outcomes, GEE is used to assess randomization arm association.||||0.228
70963067|NCT01601847|141430633|SUPERIORITY|||||||0.798|||||||Regression, Logistic|||||||0.798
70881575|NCT01480076|141247365|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881576|NCT01480076|141247365|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881577|NCT01480076|141247365|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70963068|NCT01009554|141430704|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.126|STANDARD_ERROR_OF_MEAN|0.0905||0.168|TWO_SIDED|95.0|-0.054|0.306||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter values (L, a, and b) and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.306|-0.054|0.168
70963069|NCT01009554|141430706|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.006|STANDARD_ERROR_OF_MEAN|0.067||0.928|TWO_SIDED|95.0|-0.127|0.139||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter values (L, a, and b) and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.139|-0.127|0.928
70963070|NCT01009554|141430707|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.235|STANDARD_ERROR_OF_MEAN|0.0718||0.002|TWO_SIDED|95.0|0.092|0.378||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter values (L, a, and b) and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.378|0.092|0.002
70963071|NCT01009554|141430708|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.041|STANDARD_ERROR_OF_MEAN|0.1235||0.741|TWO_SIDED|95.0|-0.205|0.286||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value L and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.286|-0.205|0.741
70963072|NCT01009554|141430709|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.161|STANDARD_ERROR_OF_MEAN|0.1386||0.249|TWO_SIDED|95.0|-0.437|0.115||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value L and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.115|-0.437|0.249
70963073|NCT01009554|141430710|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.201|STANDARD_ERROR_OF_MEAN|0.1398||0.154|TWO_SIDED|95.0|-0.479|0.077||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value L and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.077|-0.479|0.154
70963074|NCT01009554|141430711|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.195|STANDARD_ERROR_OF_MEAN|0.0746||0.011|TWO_SIDED|95.0|-0.343|-0.047||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value b and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.047|-0.343|0.011
70881578|NCT01480076|141247365|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70963075|NCT01009554|141430712|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.334|STANDARD_ERROR_OF_MEAN|0.0703|<|0.001|TWO_SIDED|95.0|-0.474|-0.195||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value b and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.195|-0.474|<0.001
70963076|NCT01009554|141430713|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.214|STANDARD_ERROR_OF_MEAN|0.0939||0.025|TWO_SIDED|95.0|-0.401|-0.027||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value b and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.027|-0.401|0.025
70963077|NCT01009554|141430714|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.056|STANDARD_ERROR_OF_MEAN|0.0562||0.319|TWO_SIDED|95.0|-0.055|0.168||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.168|-0.055|0.319
70963078|NCT01009554|141430715|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.272|STANDARD_ERROR_OF_MEAN|0.0668|<|0.001|TWO_SIDED|95.0|0.139|0.405||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.405|0.139|<0.001
70963079|NCT01009554|141430716|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.398|STANDARD_ERROR_OF_MEAN|0.084|<|0.001|TWO_SIDED|95.0|0.231|0.565||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.565|0.231|<0.001
70963080|NCT01009554|141430717|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.0271||0.27|TWO_SIDED|95.0|-0.024|0.084||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.084|-0.024|0.270
70963081|NCT01009554|141430718|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.137|STANDARD_ERROR_OF_MEAN|0.0324|<|0.001|TWO_SIDED|95.0|0.073|0.202||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.202|0.073|<0.001
70963082|NCT01009554|141430719|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.193|STANDARD_ERROR_OF_MEAN|0.0399|<|0.001|TWO_SIDED|95.0|0.114|0.273||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.273|0.114|<0.001
70963083|NCT01009554|141430720|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.034|STANDARD_ERROR_OF_MEAN|0.0273||0.217|TWO_SIDED|95.0|-0.02|0.088||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.088|-0.020|0.217
70963084|NCT01009554|141430721|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.137|STANDARD_ERROR_OF_MEAN|0.032|<|0.001|TWO_SIDED|95.0|0.073|0.2||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.200|0.073|<0.001
70963085|NCT01009554|141430722|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.195|STANDARD_ERROR_OF_MEAN|0.0406|<|0.001|TWO_SIDED|95.0|0.114|0.276||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.276|0.114|<0.001
70963086|NCT01009554|141430723|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.055|STANDARD_ERROR_OF_MEAN|0.0716||0.444|TWO_SIDED|95.0|-0.087|0.197||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area score for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.197|-0.087|0.444
70963087|NCT01009554|141430724|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.349|STANDARD_ERROR_OF_MEAN|0.0843|<|0.001|TWO_SIDED|95.0|0.182|0.517||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.517|0.182|<0.001
70881579|NCT01480076|141247365|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70963088|NCT01009554|141430725|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.542|STANDARD_ERROR_OF_MEAN|0.1063|<|0.001|TWO_SIDED|95.0|0.331|0.754||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.754|0.331|<0.001
70963089|NCT01009554|141430726|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.032|STANDARD_ERROR_OF_MEAN|0.0344||0.361|TWO_SIDED|95.0|-0.037|0.1||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.100|-0.037|0.361
70963090|NCT01009554|141430727|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.174|STANDARD_ERROR_OF_MEAN|0.0414|<|0.001|TWO_SIDED|95.0|0.092|0.256||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.256|0.092|<0.001
70963091|NCT01009554|141430728|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.264|STANDARD_ERROR_OF_MEAN|0.0504|<|0.001|TWO_SIDED|95.0|0.164|0.364||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.364|0.164|<0.001
70963092|NCT01009554|141430729|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.034|STANDARD_ERROR_OF_MEAN|0.0345||0.331|TWO_SIDED|95.0|-0.035|0.102||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.102|-0.035|0.331
70963093|NCT01009554|141430730|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.177|STANDARD_ERROR_OF_MEAN|0.0414|<|0.001|TWO_SIDED|95.0|0.095|0.259||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.259|0.095|<0.001
70963094|NCT01009554|141430731|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.265|STANDARD_ERROR_OF_MEAN|0.0519|<|0.001|TWO_SIDED|95.0|0.162|0.368||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.368|0.162|<0.001
70963095|NCT01009554|141430732|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.138|STANDARD_ERROR_OF_MEAN|0.0726||0.06|TWO_SIDED|95.0|-0.006|0.282||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.282|-0.006|0.060
70963096|NCT01009554|141430733|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.338|STANDARD_ERROR_OF_MEAN|0.087|<|0.001|TWO_SIDED|95.0|0.165|0.51||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.510|0.165|<0.001
70963097|NCT01009554|141430734|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.394|STANDARD_ERROR_OF_MEAN|0.1095|<|0.001|TWO_SIDED|95.0|0.176|0.612||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.612|0.176|<0.001
70963098|NCT01009554|141430735|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.072|STANDARD_ERROR_OF_MEAN|0.0355||0.045|TWO_SIDED|95.0|0.002|0.143||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.143|0.002|0.045
70963099|NCT01009554|141430736|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.178|STANDARD_ERROR_OF_MEAN|0.0415|<|0.001|TWO_SIDED|95.0|0.095|0.26||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.260|0.095|<0.001
70963100|NCT01009554|141430737|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.197|STANDARD_ERROR_OF_MEAN|0.052|<|0.001|TWO_SIDED|95.0|0.094|0.3||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.300|0.094|<0.001
70963101|NCT01009554|141430738|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.077|STANDARD_ERROR_OF_MEAN|0.0355||0.034|TWO_SIDED|95.0|0.006|0.147||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.147|0.006|0.034
70881580|NCT01480076|141247365|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881581|NCT01480076|141247365|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881582|NCT01480076|141247365|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881583|NCT01480076|141247365|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881584|NCT01480076|141247365|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881585|NCT01480076|141247365|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881586|NCT01480076|141247365|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881587|NCT01480076|141247365|SUPERIORITY_OR_OTHER|||||||0.0009|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0009
70881588|NCT01480076|141247365|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881589|NCT01480076|141247365|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881590|NCT01480076|141247365|SUPERIORITY_OR_OTHER|||||||0.0002|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0002
70881591|NCT01480076|141247365|SUPERIORITY_OR_OTHER|||||||0.0002|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0002
70881592|NCT01480076|141247366|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881593|NCT01480076|141247366|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881594|NCT01480076|141247366|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881595|NCT01480076|141247366|SUPERIORITY_OR_OTHER|||||||0.0032|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0032
70881596|NCT01480076|141247366|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881597|NCT01480076|141247366|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881598|NCT01480076|141247366|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881599|NCT01480076|141247366|SUPERIORITY_OR_OTHER|||||||0.0021|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0021
70881600|NCT01480076|141247366|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881601|NCT01480076|141247366|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881602|NCT01480076|141247366|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881603|NCT01480076|141247366|SUPERIORITY_OR_OTHER|||||||0.0097|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0097
70881604|NCT01480076|141247366|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881605|NCT01480076|141247366|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881606|NCT01480076|141247366|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881607|NCT01480076|141247366|SUPERIORITY_OR_OTHER|||||||0.0103|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0103
70881608|NCT01480076|141247366|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881609|NCT01480076|141247366|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881610|NCT01480076|141247366|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70963102|NCT01009554|141430739|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.168|STANDARD_ERROR_OF_MEAN|0.0398|<|0.001|TWO_SIDED|95.0|0.089|0.247||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.247|0.089|<0.001
70881611|NCT01480076|141247366|SUPERIORITY_OR_OTHER|||||||0.1227|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1227
70881612|NCT01480076|141247367|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881613|NCT01480076|141247367|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881614|NCT01480076|141247367|SUPERIORITY_OR_OTHER|||||||0.1754|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1754
70963103|NCT01009554|141430740|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.193|STANDARD_ERROR_OF_MEAN|0.0516|<|0.001|TWO_SIDED|95.0|0.091|0.296||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.296|0.091|<0.001
70881615|NCT01480076|141247367|SUPERIORITY_OR_OTHER|||||||0.0192|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0192
70881616|NCT01480076|141247367|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881617|NCT01480076|141247367|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881618|NCT01480076|141247367|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0001
70881619|NCT01480076|141247367|SUPERIORITY_OR_OTHER|||||||0.0157|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0157
70881620|NCT01480076|141247367|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70963104|NCT01009554|141430741|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.031||0.524|TWO_SIDED|95.0|-0.082|0.042||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.042|-0.082|0.524
70963105|NCT01009554|141430742|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.055|STANDARD_ERROR_OF_MEAN|0.0395||0.172|TWO_SIDED|95.0|-0.024|0.133||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.133|-0.024|0.172
70881621|NCT01480076|141247367|SUPERIORITY_OR_OTHER|||||||0.0002|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0002
70881622|NCT01480076|141247367|SUPERIORITY_OR_OTHER|||||||0.1012|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1012
70881623|NCT01480076|141247367|SUPERIORITY_OR_OTHER|||||||0.0749|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0749
70881624|NCT01480076|141247367|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881625|NCT01480076|141247367|SUPERIORITY_OR_OTHER|||||||0.0455|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0455
70963106|NCT01009554|141430743|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.116|STANDARD_ERROR_OF_MEAN|0.0439||0.01|TWO_SIDED|95.0|0.028|0.203||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.203|0.028|0.010
70881626|NCT01480076|141247367|SUPERIORITY_OR_OTHER|||||||0.4699|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4699
70881627|NCT01480076|141247367|SUPERIORITY_OR_OTHER|||||||0.0235|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0235
70881628|NCT01480076|141247367|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70963107|NCT01009554|141430744|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.014|STANDARD_ERROR_OF_MEAN|0.0145||0.348|TWO_SIDED|95.0|-0.043|0.015||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.015|-0.043|0.348
70881629|NCT01480076|141247367|SUPERIORITY_OR_OTHER|||||||0.1978|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1978
70881630|NCT01480076|141247367|SUPERIORITY_OR_OTHER|||||||0.1977|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1977
70963108|NCT01009554|141430745|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.025|STANDARD_ERROR_OF_MEAN|0.0186||0.185|TWO_SIDED|95.0|-0.012|0.062||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.062|-0.012|0.185
70881631|NCT01480076|141247367|SUPERIORITY_OR_OTHER|||||||0.225|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2250
70881632|NCT01480076|141247368|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70963109|NCT01009554|141430746|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.049|STANDARD_ERROR_OF_MEAN|0.0196||0.014|TWO_SIDED|95.0|0.01|0.088||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.088|0.010|0.014
70963110|NCT01009554|141430747|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.008|STANDARD_ERROR_OF_MEAN|0.016||0.623|TWO_SIDED|95.0|-0.04|0.024||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.024|-0.040|0.623
70881633|NCT01480076|141247368|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70963111|NCT01009554|141430748|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.024|STANDARD_ERROR_OF_MEAN|0.0186||0.192|TWO_SIDED|95.0|-0.013|0.061||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.061|-0.013|0.192
70881634|NCT01480076|141247368|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881635|NCT01480076|141247368|SUPERIORITY_OR_OTHER|||||||0.0649|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0649
70881636|NCT01480076|141247368|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881637|NCT01480076|141247368|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881638|NCT01480076|141247368|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881639|NCT01480076|141247368|SUPERIORITY_OR_OTHER|||||||0.1138|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1138
70881640|NCT01480076|141247368|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70963112|NCT01009554|141430749|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.057|STANDARD_ERROR_OF_MEAN|0.0213||0.009|TWO_SIDED|95.0|0.014|0.099||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.099|0.014|0.009
70963113|NCT01009554|141430750|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.005|STANDARD_ERROR_OF_MEAN|0.0384||0.893|TWO_SIDED|95.0|-0.081|0.071||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.071|-0.081|0.893
70963114|NCT01009554|141430751|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.021|STANDARD_ERROR_OF_MEAN|0.0476||0.655|TWO_SIDED|95.0|-0.073|0.116||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.116|-0.073|0.655
70963115|NCT01009554|141430752|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.222|STANDARD_ERROR_OF_MEAN|0.0693||0.002|TWO_SIDED|95.0|0.084|0.359||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.359|0.084|0.002
70963116|NCT01009554|141430753|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.002|STANDARD_ERROR_OF_MEAN|0.0187||0.914|TWO_SIDED|95.0|-0.039|0.035||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.035|-0.039|0.914
70963117|NCT01009554|141430754|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.011|STANDARD_ERROR_OF_MEAN|0.0229||0.646|TWO_SIDED|95.0|-0.035|0.056||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.056|-0.035|0.646
70963118|NCT01009554|141430755|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.102|STANDARD_ERROR_OF_MEAN|0.0309||0.001|TWO_SIDED|95.0|0.04|0.163||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.163|0.040|0.001
70963119|NCT01009554|141430756|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.002|STANDARD_ERROR_OF_MEAN|0.0179||0.93|TWO_SIDED|95.0|-0.034|0.037||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.037|-0.034|0.930
70881641|NCT01480076|141247368|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881642|NCT01480076|141247368|SUPERIORITY_OR_OTHER|||||||0.0003|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0003
70881643|NCT01480076|141247368|SUPERIORITY_OR_OTHER|||||||0.185|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1850
70881644|NCT01480076|141247368|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881645|NCT01480076|141247368|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881646|NCT01480076|141247368|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881647|NCT01480076|141247368|SUPERIORITY_OR_OTHER|||||||0.0887|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0887
70881648|NCT01480076|141247368|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881649|NCT01480076|141247368|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881650|NCT01480076|141247368|SUPERIORITY_OR_OTHER|||||||0.0011|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0011
70881651|NCT01480076|141247368|SUPERIORITY_OR_OTHER|||||||0.1853|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1853
70881652|NCT01480076|141247369|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881653|NCT01480076|141247369|SUPERIORITY_OR_OTHER|||||||0.0005|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0005
70881654|NCT01480076|141247369|SUPERIORITY_OR_OTHER|||||||0.0027|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0027
70881655|NCT01480076|141247369|SUPERIORITY_OR_OTHER|||||||0.0167|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0167
70881656|NCT01480076|141247369|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881657|NCT01480076|141247369|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881658|NCT01480076|141247369|SUPERIORITY_OR_OTHER|||||||0.0024|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0024
70881659|NCT01480076|141247369|SUPERIORITY_OR_OTHER|||||||0.0669|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0669
70881660|NCT01480076|141247369|SUPERIORITY_OR_OTHER|||||||0.0018|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0018
70881661|NCT01480076|141247369|SUPERIORITY_OR_OTHER|||||||0.0004|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0004
70881662|NCT01480076|141247369|SUPERIORITY_OR_OTHER|||||||0.019|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0190
70881663|NCT01480076|141247369|SUPERIORITY_OR_OTHER|||||||0.0106|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0106
70881664|NCT01480076|141247369|SUPERIORITY_OR_OTHER|||||||0.0009|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0009
70881665|NCT01480076|141247369|SUPERIORITY_OR_OTHER|||||||0.1937|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1937
70881666|NCT01480076|141247369|SUPERIORITY_OR_OTHER|||||||0.0445|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0445
70881667|NCT01480076|141247369|SUPERIORITY_OR_OTHER|||||||0.6475|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6475
70881668|NCT01480076|141247369|SUPERIORITY_OR_OTHER|||||||0.0097|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0097
70881669|NCT01480076|141247369|SUPERIORITY_OR_OTHER|||||||0.0386|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0386
70881670|NCT01480076|141247369|SUPERIORITY_OR_OTHER|||||||0.0219|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0219
70881671|NCT01480076|141247369|SUPERIORITY_OR_OTHER|||||||0.0076|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0076
70881672|NCT01480076|141247370|SUPERIORITY_OR_OTHER|||||||0.1471|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1471
70881673|NCT01480076|141247370|SUPERIORITY_OR_OTHER|||||||0.5503|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5503
70881674|NCT01480076|141247370|SUPERIORITY_OR_OTHER|||||||0.3854|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.3854
70881675|NCT01480076|141247370|SUPERIORITY_OR_OTHER|||||||0.4893|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.4893
70881676|NCT01480076|141247370|SUPERIORITY_OR_OTHER|||||||0.2166|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2166
70881677|NCT01480076|141247370|SUPERIORITY_OR_OTHER|||||||0.4149|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.4149
70881678|NCT01480076|141247370|SUPERIORITY_OR_OTHER|||||||0.3849|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.3849
70881679|NCT01480076|141247370|SUPERIORITY_OR_OTHER|||||||0.898|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.8980
70881680|NCT01480076|141247370|SUPERIORITY_OR_OTHER|||||||0.0046|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0046
70881681|NCT01480076|141247370|SUPERIORITY_OR_OTHER|||||||0.0594|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0594
70881682|NCT01480076|141247370|SUPERIORITY_OR_OTHER|||||||0.2975|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2975
70881683|NCT01480076|141247370|SUPERIORITY_OR_OTHER|||||||0.7155|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.7155
70881684|NCT01480076|141247370|SUPERIORITY_OR_OTHER|||||||0.507|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5070
70881685|NCT01480076|141247370|SUPERIORITY_OR_OTHER|||||||0.5848|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5848
70881686|NCT01480076|141247370|SUPERIORITY_OR_OTHER|||||||0.802|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.8020
70881687|NCT01480076|141247370|SUPERIORITY_OR_OTHER|||||||0.254|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2540
70881688|NCT01480076|141247370|SUPERIORITY_OR_OTHER|||||||0.9057|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.9057
70881689|NCT01480076|141247370|SUPERIORITY_OR_OTHER|||||||0.9679|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.9679
70881690|NCT01480076|141247370|SUPERIORITY_OR_OTHER|||||||0.5875|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5875
70881691|NCT01480076|141247370|SUPERIORITY_OR_OTHER|||||||0.744|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.7440
70881692|NCT01480076|141247371|SUPERIORITY_OR_OTHER|||||||0.0032|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0032
70881693|NCT01480076|141247371|SUPERIORITY_OR_OTHER|||||||0.0828|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0828
70881694|NCT01480076|141247371|SUPERIORITY_OR_OTHER|||||||0.7756|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.7756
70881695|NCT01480076|141247371|SUPERIORITY_OR_OTHER|||||||0.22|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2200
70881696|NCT01480076|141247371|SUPERIORITY_OR_OTHER|||||||0.0002|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0002
70881697|NCT01480076|141247371|SUPERIORITY_OR_OTHER|||||||0.0061|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0061
70881698|NCT01480076|141247371|SUPERIORITY_OR_OTHER|||||||0.6258|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.6258
70881699|NCT01480076|141247371|SUPERIORITY_OR_OTHER|||||||0.6987|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.6987
70881700|NCT01480076|141247371|SUPERIORITY_OR_OTHER|||||||0.0025|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0025
70881701|NCT01480076|141247371|SUPERIORITY_OR_OTHER|||||||0.0021|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0021
70881702|NCT01480076|141247371|SUPERIORITY_OR_OTHER|||||||0.4385|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.4385
70881703|NCT01480076|141247371|SUPERIORITY_OR_OTHER|||||||0.2275|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2275
70881704|NCT01480076|141247371|SUPERIORITY_OR_OTHER|||||||0.0446|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0446
70881705|NCT01480076|141247371|SUPERIORITY_OR_OTHER|||||||0.5757|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5757
70881706|NCT01480076|141247371|SUPERIORITY_OR_OTHER|||||||0.8936|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.8936
70881707|NCT01480076|141247371|SUPERIORITY_OR_OTHER|||||||0.5675|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5675
70881708|NCT01480076|141247371|SUPERIORITY_OR_OTHER|||||||0.2539|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2539
70881709|NCT01480076|141247371|SUPERIORITY_OR_OTHER|||||||0.6673|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.6673
70881710|NCT01480076|141247371|SUPERIORITY_OR_OTHER|||||||0.0849|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0849
70881711|NCT01480076|141247371|SUPERIORITY_OR_OTHER|||||||0.1187|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1187
70881712|NCT01480076|141247372|SUPERIORITY_OR_OTHER|||||||0.0022|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0022
70881713|NCT01480076|141247372|SUPERIORITY_OR_OTHER|||||||0.0299|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0299
70881714|NCT01480076|141247372|SUPERIORITY_OR_OTHER|||||||0.8135|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.8135
70881715|NCT01480076|141247372|SUPERIORITY_OR_OTHER|||||||0.3526|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.3526
70881716|NCT01480076|141247372|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0001
70881717|NCT01480076|141247372|SUPERIORITY_OR_OTHER|||||||0.0039|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0039
70881718|NCT01480076|141247372|SUPERIORITY_OR_OTHER|||||||0.6924|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.6924
70881719|NCT01480076|141247372|SUPERIORITY_OR_OTHER|||||||0.7639|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.7639
70881720|NCT01480076|141247372|SUPERIORITY_OR_OTHER|||||||0.0013|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0013
70881721|NCT01480076|141247372|SUPERIORITY_OR_OTHER|||||||0.0011|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0011
70881722|NCT01480076|141247372|SUPERIORITY_OR_OTHER|||||||0.434|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.4340
70881723|NCT01480076|141247372|SUPERIORITY_OR_OTHER|||||||0.4224|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.4224
70881724|NCT01480076|141247372|SUPERIORITY_OR_OTHER|||||||0.1628|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1628
70963120|NCT01009554|141430757|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.016|STANDARD_ERROR_OF_MEAN|0.0224||0.486|TWO_SIDED|95.0|-0.029|0.06||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.060|-0.029|0.486
70881725|NCT01480076|141247372|SUPERIORITY_OR_OTHER|||||||0.5666|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5666
70881726|NCT01480076|141247372|SUPERIORITY_OR_OTHER|||||||0.8315|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.8315
70881727|NCT01480076|141247372|SUPERIORITY_OR_OTHER|||||||0.3852|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.3852
70881728|NCT01480076|141247372|SUPERIORITY_OR_OTHER|||||||0.0652|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0652
70881729|NCT01480076|141247372|SUPERIORITY_OR_OTHER|||||||0.5719|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5719
70881730|NCT01480076|141247372|SUPERIORITY_OR_OTHER|||||||0.9237|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.9237
70881731|NCT01480076|141247372|SUPERIORITY_OR_OTHER|||||||0.131|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1310
70881732|NCT01480076|141247373|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881733|NCT01480076|141247373|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881734|NCT01480076|141247373|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0001
70881735|NCT01480076|141247373|SUPERIORITY_OR_OTHER|||||||0.0003|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0003
70881736|NCT01480076|141247373|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881737|NCT01480076|141247373|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881738|NCT01480076|141247373|SUPERIORITY_OR_OTHER|||||||0.0002|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0002
70881739|NCT01480076|141247373|SUPERIORITY_OR_OTHER|||||||0.0102|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0102
70881740|NCT01480076|141247373|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881741|NCT01480076|141247373|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881742|NCT01480076|141247373|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0001
70881743|NCT01480076|141247373|SUPERIORITY_OR_OTHER|||||||0.0012|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0012
70881744|NCT01480076|141247373|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881745|NCT01480076|141247373|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881746|NCT01480076|141247373|SUPERIORITY_OR_OTHER|||||||0.0026|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0026
70881747|NCT01480076|141247373|SUPERIORITY_OR_OTHER|||||||0.0161|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0161
70881748|NCT01480076|141247373|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881749|NCT01480076|141247373|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
70881750|NCT01480076|141247373|SUPERIORITY_OR_OTHER|||||||0.1151|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1151
70881751|NCT01480076|141247373|SUPERIORITY_OR_OTHER|||||||0.004|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0040
70881752|NCT01480076|141247374|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881753|NCT01480076|141247374|SUPERIORITY_OR_OTHER|||||||0.6769|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6769
70881754|NCT01480076|141247374|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881755|NCT01480076|141247374|SUPERIORITY_OR_OTHER|||||||0.578|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5780
70881756|NCT01480076|141247374|SUPERIORITY_OR_OTHER||difference of LS means|3.4|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881757|NCT01480076|141247374|SUPERIORITY_OR_OTHER||difference of LS means|4.5|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881758|NCT01480076|141247374|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881759|NCT01480076|141247374|SUPERIORITY_OR_OTHER|||||||0.8886|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8886
70881760|NCT01480076|141247374|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881761|NCT01480076|141247374|SUPERIORITY_OR_OTHER|||||||0.3221|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3221
70881762|NCT01480076|141247374|SUPERIORITY_OR_OTHER||difference of LS means|3.9|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881763|NCT01480076|141247374|SUPERIORITY_OR_OTHER||difference of LS means|5.3|STANDARD_ERROR_OF_MEAN|1.23|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881764|NCT01480076|141247374|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881765|NCT01480076|141247374|SUPERIORITY_OR_OTHER|||||||0.4668|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4668
70881766|NCT01480076|141247374|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881767|NCT01480076|141247374|SUPERIORITY_OR_OTHER|||||||0.5695|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5695
70881768|NCT01480076|141247374|SUPERIORITY_OR_OTHER||difference of LS means|2.4|STANDARD_ERROR_OF_MEAN|0.88||0.0058|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0058
70881769|NCT01480076|141247374|SUPERIORITY_OR_OTHER||difference of LS means|4.6|STANDARD_ERROR_OF_MEAN|1.4||0.001|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0010
70881770|NCT01480076|141247374|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881771|NCT01480076|141247374|SUPERIORITY_OR_OTHER|||||||0.204|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2040
70881772|NCT01480076|141247374|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881773|NCT01480076|141247374|SUPERIORITY_OR_OTHER|||||||0.6306|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6306
70881774|NCT01480076|141247374|SUPERIORITY_OR_OTHER||difference of LS means|3.9|STANDARD_ERROR_OF_MEAN|0.9|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non- responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881775|NCT01480076|141247374|SUPERIORITY_OR_OTHER||difference of LS means|4.7|STANDARD_ERROR_OF_MEAN|1.51||0.002|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0020
70881776|NCT01480076|141247374|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881777|NCT01480076|141247374|SUPERIORITY_OR_OTHER|||||||0.4052|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4052
70881778|NCT01480076|141247374|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881779|NCT01480076|141247374|SUPERIORITY_OR_OTHER|||||||0.8626|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8626
70881780|NCT01480076|141247374|SUPERIORITY_OR_OTHER||difference of LS means|3.3|STANDARD_ERROR_OF_MEAN|0.93||0.0004|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0004
70881781|NCT01480076|141247374|SUPERIORITY_OR_OTHER||difference of LS means|3.3|STANDARD_ERROR_OF_MEAN|1.49||0.0263|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0263
70881782|NCT01480076|141247375|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881783|NCT01480076|141247375|SUPERIORITY_OR_OTHER|||||||0.8999|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8999
70881784|NCT01480076|141247375|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881785|NCT01480076|141247375|SUPERIORITY_OR_OTHER|||||||0.7156|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7156
70881786|NCT01480076|141247375|SUPERIORITY_OR_OTHER||difference of LS means|2.9|STANDARD_ERROR_OF_MEAN|1.03||0.005|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0050
70881787|NCT01480076|141247375|SUPERIORITY_OR_OTHER||difference of LS means|3.3|STANDARD_ERROR_OF_MEAN|1.68||0.049|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0490
70881788|NCT01480076|141247375|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881789|NCT01480076|141247375|SUPERIORITY_OR_OTHER|||||||0.274|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2740
70881790|NCT01480076|141247375|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881791|NCT01480076|141247375|SUPERIORITY_OR_OTHER|||||||0.5556|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5556
70881792|NCT01480076|141247375|SUPERIORITY_OR_OTHER||difference of LS means|5.2|STANDARD_ERROR_OF_MEAN|1.15|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881793|NCT01480076|141247375|SUPERIORITY_OR_OTHER||difference of LS means|3.7|STANDARD_ERROR_OF_MEAN|1.88||0.0476|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0476
70881794|NCT01480076|141247375|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881795|NCT01480076|141247375|SUPERIORITY_OR_OTHER|||||||0.8627|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8627
70881796|NCT01480076|141247375|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881797|NCT01480076|141247375|SUPERIORITY_OR_OTHER|||||||0.4312|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4312
70881798|NCT01480076|141247375|SUPERIORITY_OR_OTHER||difference of LS means|2.8|STANDARD_ERROR_OF_MEAN|1.27||0.0305|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0305
70881799|NCT01480076|141247375|SUPERIORITY_OR_OTHER||difference of LS means|2.6|STANDARD_ERROR_OF_MEAN|2.03||0.2059|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2059
70881800|NCT01480076|141247375|SUPERIORITY_OR_OTHER|||||||0.0008|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0008
70881801|NCT01480076|141247375|SUPERIORITY_OR_OTHER|||||||0.3685|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3685
70881802|NCT01480076|141247375|SUPERIORITY_OR_OTHER|||||||0.0016|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0016
70881803|NCT01480076|141247375|SUPERIORITY_OR_OTHER|||||||0.9862|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9862
70881804|NCT01480076|141247375|SUPERIORITY_OR_OTHER||difference of LS means|0.8|STANDARD_ERROR_OF_MEAN|1.38||0.5561|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5561
70881805|NCT01480076|141247375|SUPERIORITY_OR_OTHER||difference of LS means|2.8|STANDARD_ERROR_OF_MEAN|2.32||0.2281|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2281
70881806|NCT01480076|141247375|SUPERIORITY_OR_OTHER|||||||0.0006|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0006
70881807|NCT01480076|141247375|SUPERIORITY_OR_OTHER|||||||0.6004|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6004
70881808|NCT01480076|141247375|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70963121|NCT01009554|141430758|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.112|STANDARD_ERROR_OF_MEAN|0.0338||0.001|TWO_SIDED|95.0|0.045|0.18||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.180|0.045|0.001
70881809|NCT01480076|141247375|SUPERIORITY_OR_OTHER|||||||0.904|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9040
70963122|NCT01009554|141430759|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.1006||0.237|TWO_SIDED|95.0|-0.08|0.32||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.320|-0.080|0.237
70881810|NCT01480076|141247375|SUPERIORITY_OR_OTHER||difference of LS means|2.8|STANDARD_ERROR_OF_MEAN|1.38||0.0401|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0401
70881811|NCT01480076|141247375|SUPERIORITY_OR_OTHER||difference of LS means|4.1|STANDARD_ERROR_OF_MEAN|2.23||0.0651|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0651
70881812|NCT01480076|141247376|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881813|NCT01480076|141247376|SUPERIORITY_OR_OTHER|||||||0.454|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4540
70881814|NCT01480076|141247376|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881815|NCT01480076|141247376|SUPERIORITY_OR_OTHER|||||||0.2949|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2949
70881816|NCT01480076|141247376|SUPERIORITY_OR_OTHER||difference of LS means|-8.1|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881817|NCT01480076|141247376|SUPERIORITY_OR_OTHER||difference of LS means|-9.0|STANDARD_ERROR_OF_MEAN|3.16||0.0046|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0046
70881818|NCT01480076|141247376|SUPERIORITY_OR_OTHER||difference of LS means|-12.6|STANDARD_ERROR_OF_MEAN|1.07|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881819|NCT01480076|141247376|SUPERIORITY_OR_OTHER|||||||0.502|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5020
70881820|NCT01480076|141247376|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881821|NCT01480076|141247376|SUPERIORITY_OR_OTHER|||||||0.2157|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2157
70881822|NCT01480076|141247376|SUPERIORITY_OR_OTHER||difference of LS means|-11.2|STANDARD_ERROR_OF_MEAN|2.0|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881823|NCT01480076|141247376|SUPERIORITY_OR_OTHER||difference of LS means|-10.0|STANDARD_ERROR_OF_MEAN|3.3||0.0026|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0026
70881824|NCT01480076|141247376|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70963123|NCT01009554|141430760|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.521|STANDARD_ERROR_OF_MEAN|0.112|<|0.001|TWO_SIDED|95.0|0.298|0.743||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.743|0.298|<0.001
70881825|NCT01480076|141247376|SUPERIORITY_OR_OTHER|||||||0.3435|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3435
70881826|NCT01480076|141247376|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881827|NCT01480076|141247376|SUPERIORITY_OR_OTHER|||||||0.1357|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1357
70881828|NCT01480076|141247376|SUPERIORITY_OR_OTHER||difference of LS means|-7.8|STANDARD_ERROR_OF_MEAN|2.22||0.0004|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0004
70881829|NCT01480076|141247376|SUPERIORITY_OR_OTHER||difference of LS means|-7.0|STANDARD_ERROR_OF_MEAN|3.58||0.0511|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0511
70881830|NCT01480076|141247376|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881831|NCT01480076|141247376|SUPERIORITY_OR_OTHER|||||||0.8703|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8703
70881832|NCT01480076|141247376|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881833|NCT01480076|141247376|SUPERIORITY_OR_OTHER|||||||0.9049|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9049
70881834|NCT01480076|141247376|SUPERIORITY_OR_OTHER||difference of LS means|-7.6|STANDARD_ERROR_OF_MEAN|2.44||0.0019|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0019
70881835|NCT01480076|141247376|SUPERIORITY_OR_OTHER||difference of LS means|-12.3|STANDARD_ERROR_OF_MEAN|4.15||0.0033|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0033
70881836|NCT01480076|141247376|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881837|NCT01480076|141247376|SUPERIORITY_OR_OTHER|||||||0.4087|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4087
70881838|NCT01480076|141247376|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881839|NCT01480076|141247376|SUPERIORITY_OR_OTHER|||||||0.2755|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2755
70881840|NCT01480076|141247376|SUPERIORITY_OR_OTHER||difference of LS means|-5.7|STANDARD_ERROR_OF_MEAN|2.52||0.0251|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0251
70881841|NCT01480076|141247376|SUPERIORITY_OR_OTHER||difference of LS means|-6.7|STANDARD_ERROR_OF_MEAN|4.08||0.0989|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0989
70881842|NCT01480076|141247377|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881843|NCT01480076|141247377|SUPERIORITY_OR_OTHER|||||||0.8767|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8767
70881844|NCT01480076|141247377|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881845|NCT01480076|141247377|SUPERIORITY_OR_OTHER|||||||0.3673|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3673
70881846|NCT01480076|141247377|SUPERIORITY_OR_OTHER||difference of LS means|-6.8|STANDARD_ERROR_OF_MEAN|1.91||0.0004|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0004
70881847|NCT01480076|141247377|SUPERIORITY_OR_OTHER||difference of LS means|-6.9|STANDARD_ERROR_OF_MEAN|3.12||0.0273|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0273
70881848|NCT01480076|141247377|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881849|NCT01480076|141247377|SUPERIORITY_OR_OTHER|||||||0.9091|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9091
70881850|NCT01480076|141247377|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881851|NCT01480076|141247377|SUPERIORITY_OR_OTHER|||||||0.7718|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7718
70881852|NCT01480076|141247377|SUPERIORITY_OR_OTHER||difference of LS means|-9.2|STANDARD_ERROR_OF_MEAN|2.11|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881853|NCT01480076|141247377|SUPERIORITY_OR_OTHER||difference of LS means|-10.1|STANDARD_ERROR_OF_MEAN|3.5||0.0038|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0038
70881854|NCT01480076|141247377|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881855|NCT01480076|141247377|SUPERIORITY_OR_OTHER|||||||0.272|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2720
70881856|NCT01480076|141247377|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881857|NCT01480076|141247377|SUPERIORITY_OR_OTHER|||||||0.4767|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4767
70881858|NCT01480076|141247377|SUPERIORITY_OR_OTHER||difference of LS means|-4.5|STANDARD_ERROR_OF_MEAN|2.32||0.0553|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0553
70881859|NCT01480076|141247377|SUPERIORITY_OR_OTHER||difference of LS means|-6.9|STANDARD_ERROR_OF_MEAN|3.73||0.0632|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0632
70881860|NCT01480076|141247377|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881861|NCT01480076|141247377|SUPERIORITY_OR_OTHER|||||||0.9398|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9398
70881862|NCT01480076|141247377|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881863|NCT01480076|141247377|SUPERIORITY_OR_OTHER|||||||0.5655|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5655
70881864|NCT01480076|141247377|SUPERIORITY_OR_OTHER||difference of LS means|-5.9|STANDARD_ERROR_OF_MEAN|2.54||0.0204|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0204
70881865|NCT01480076|141247377|SUPERIORITY_OR_OTHER||difference of LS means|-6.4|STANDARD_ERROR_OF_MEAN|4.37||0.1414|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1414
70881866|NCT01480076|141247377|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881867|NCT01480076|141247377|SUPERIORITY_OR_OTHER|||||||0.6279|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6279
70881868|NCT01480076|141247377|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881869|NCT01480076|141247377|SUPERIORITY_OR_OTHER|||||||0.2239|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2239
70881870|NCT01480076|141247377|SUPERIORITY_OR_OTHER||difference of LS means|-7.5|STANDARD_ERROR_OF_MEAN|2.67||0.0049|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0049
70881871|NCT01480076|141247377|SUPERIORITY_OR_OTHER||difference of LS means|-4.1|STANDARD_ERROR_OF_MEAN|4.32||0.3457|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3457
70881872|NCT01480076|141247378|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881873|NCT01480076|141247378|SUPERIORITY_OR_OTHER|||||||0.2087|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2087
70881874|NCT01480076|141247378|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881875|NCT01480076|141247378|SUPERIORITY_OR_OTHER|||||||0.4487|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4487
70881876|NCT01480076|141247378|SUPERIORITY_OR_OTHER||difference of LS means|-2.1|STANDARD_ERROR_OF_MEAN|0.64||0.0013|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0013
70881877|NCT01480076|141247378|SUPERIORITY_OR_OTHER||difference of LS means|-2.7|STANDARD_ERROR_OF_MEAN|1.15||0.0188|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0188
70881878|NCT01480076|141247378|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881879|NCT01480076|141247378|SUPERIORITY_OR_OTHER|||||||0.4243|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4243
70881880|NCT01480076|141247378|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881881|NCT01480076|141247378|SUPERIORITY_OR_OTHER|||||||0.9989|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9989
70881882|NCT01480076|141247378|SUPERIORITY_OR_OTHER||difference of LS means|-1.6|STANDARD_ERROR_OF_MEAN|0.68||0.0207|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0207
70881883|NCT01480076|141247378|SUPERIORITY_OR_OTHER||difference of LS means|-2.9|STANDARD_ERROR_OF_MEAN|1.18||0.0161|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0161
70881884|NCT01480076|141247378|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881885|NCT01480076|141247378|SUPERIORITY_OR_OTHER|||||||0.4256|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4256
70881886|NCT01480076|141247378|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881887|NCT01480076|141247378|SUPERIORITY_OR_OTHER|||||||0.3313|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3313
70963124|NCT01009554|141430761|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.567|STANDARD_ERROR_OF_MEAN|0.1367|<|0.001|TWO_SIDED|95.0|0.295|0.839||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.839|0.295|<0.001
70881888|NCT01480076|141247378|SUPERIORITY_OR_OTHER||difference of LS means|-1.9|STANDARD_ERROR_OF_MEAN|0.83||0.0238|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0238
70881889|NCT01480076|141247378|SUPERIORITY_OR_OTHER||difference of LS means|-3.4|STANDARD_ERROR_OF_MEAN|1.39||0.015|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0150
70881890|NCT01480076|141247378|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881891|NCT01480076|141247378|SUPERIORITY_OR_OTHER|||||||0.0171|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0171
70881892|NCT01480076|141247378|SUPERIORITY_OR_OTHER|||||||0.0007|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0007
70881893|NCT01480076|141247378|SUPERIORITY_OR_OTHER|||||||0.5146|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5146
70881894|NCT01480076|141247378|SUPERIORITY_OR_OTHER||difference of LS means|-3.0|STANDARD_ERROR_OF_MEAN|0.84||0.0003|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0003
70881895|NCT01480076|141247378|SUPERIORITY_OR_OTHER||difference of LS means|-2.7|STANDARD_ERROR_OF_MEAN|1.72||0.1224|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1224
70881896|NCT01480076|141247378|SUPERIORITY_OR_OTHER|||||||0.0168|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0168
70881897|NCT01480076|141247378|SUPERIORITY_OR_OTHER|||||||0.2272|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2272
70881898|NCT01480076|141247378|SUPERIORITY_OR_OTHER|||||||0.057|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0570
70881899|NCT01480076|141247378|SUPERIORITY_OR_OTHER|||||||0.5832|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5832
70881900|NCT01480076|141247378|SUPERIORITY_OR_OTHER||difference of LS means|-1.8|STANDARD_ERROR_OF_MEAN|0.94||0.0561|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0561
70881901|NCT01480076|141247378|SUPERIORITY_OR_OTHER||difference of LS means|-1.9|STANDARD_ERROR_OF_MEAN|1.86||0.2971|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2971
70881902|NCT01480076|141247379|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881903|NCT01480076|141247379|SUPERIORITY_OR_OTHER|||||||0.0029|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0029
70881904|NCT01480076|141247379|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881905|NCT01480076|141247379|SUPERIORITY_OR_OTHER|||||||0.8041|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8041
70881906|NCT01480076|141247379|SUPERIORITY_OR_OTHER||difference of LS means|11.8|STANDARD_ERROR_OF_MEAN|1.85|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881907|NCT01480076|141247379|SUPERIORITY_OR_OTHER||difference of LS means|9.4|STANDARD_ERROR_OF_MEAN|3.1||0.0026|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0026
70881908|NCT01480076|141247379|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881909|NCT01480076|141247379|SUPERIORITY_OR_OTHER|||||||0.0689|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0689
70881910|NCT01480076|141247379|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881911|NCT01480076|141247379|SUPERIORITY_OR_OTHER|||||||0.7182|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7182
70881912|NCT01480076|141247379|SUPERIORITY_OR_OTHER||difference of LS means|11.6|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881913|NCT01480076|141247379|SUPERIORITY_OR_OTHER||difference of LS means|9.8|STANDARD_ERROR_OF_MEAN|3.57||0.0061|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0061
70881914|NCT01480076|141247379|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881915|NCT01480076|141247379|SUPERIORITY_OR_OTHER|||||||0.0179|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0179
70881916|NCT01480076|141247379|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881917|NCT01480076|141247379|SUPERIORITY_OR_OTHER|||||||0.6911|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6911
70881918|NCT01480076|141247379|SUPERIORITY_OR_OTHER||difference of LS means|10.8|STANDARD_ERROR_OF_MEAN|2.31|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881919|NCT01480076|141247379|SUPERIORITY_OR_OTHER||difference of LS means|7.1|STANDARD_ERROR_OF_MEAN|3.85||0.0666|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0666
70881920|NCT01480076|141247379|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881921|NCT01480076|141247379|SUPERIORITY_OR_OTHER|||||||0.0158|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0158
70881922|NCT01480076|141247379|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881923|NCT01480076|141247379|SUPERIORITY_OR_OTHER|||||||0.6684|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6684
70881924|NCT01480076|141247379|SUPERIORITY_OR_OTHER||difference of LS means|11.6|STANDARD_ERROR_OF_MEAN|2.49|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881925|NCT01480076|141247379|SUPERIORITY_OR_OTHER||difference of LS means|10.5|STANDARD_ERROR_OF_MEAN|4.28||0.0141|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0141
70881926|NCT01480076|141247379|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881927|NCT01480076|141247379|SUPERIORITY_OR_OTHER|||||||0.0042|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0042
70881928|NCT01480076|141247379|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881929|NCT01480076|141247379|SUPERIORITY_OR_OTHER|||||||0.7329|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7329
70881930|NCT01480076|141247379|SUPERIORITY_OR_OTHER||difference of LS means|13.2|STANDARD_ERROR_OF_MEAN|2.65|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881931|NCT01480076|141247379|SUPERIORITY_OR_OTHER||difference of LS means|10.1|STANDARD_ERROR_OF_MEAN|4.49||0.0242|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0242
70881932|NCT01480076|141247380|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0001
70881933|NCT01480076|141247380|SUPERIORITY_OR_OTHER|||||||0.9151|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9151
70881934|NCT01480076|141247380|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881935|NCT01480076|141247380|SUPERIORITY_OR_OTHER|||||||0.6128|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6128
70881936|NCT01480076|141247380|SUPERIORITY_OR_OTHER||difference of LS means|0.05|STANDARD_ERROR_OF_MEAN|0.02||0.0331|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0331
70881937|NCT01480076|141247380|SUPERIORITY_OR_OTHER||difference of LS means|0.05|STANDARD_ERROR_OF_MEAN|0.04||0.1919|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1919
70881938|NCT01480076|141247380|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881939|NCT01480076|141247380|SUPERIORITY_OR_OTHER|||||||0.4481|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4481
70881940|NCT01480076|141247380|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70881941|NCT01480076|141247380|SUPERIORITY_OR_OTHER|||||||0.5454|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5454
70881942|NCT01480076|141247380|SUPERIORITY_OR_OTHER||difference of LS means|0.05|STANDARD_ERROR_OF_MEAN|0.02||0.0516|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0516
70881943|NCT01480076|141247380|SUPERIORITY_OR_OTHER||difference of LS means|0.09|STANDARD_ERROR_OF_MEAN|0.04||0.0175|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0175
70881944|NCT01480076|141247380|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0001
70881945|NCT01480076|141247380|SUPERIORITY_OR_OTHER|||||||0.9371|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9371
70881946|NCT01480076|141247380|SUPERIORITY_OR_OTHER|||||||0.0056|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0056
70881947|NCT01480076|141247380|SUPERIORITY_OR_OTHER|||||||0.5475|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5475
70881948|NCT01480076|141247380|SUPERIORITY_OR_OTHER||difference of LS means|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.0699|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0699
70881949|NCT01480076|141247380|SUPERIORITY_OR_OTHER||difference of LS means|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.587|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5870
70881950|NCT01480076|141247380|SUPERIORITY_OR_OTHER|||||||0.0245|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0245
70881951|NCT01480076|141247380|SUPERIORITY_OR_OTHER|||||||0.9926|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9926
70881952|NCT01480076|141247380|SUPERIORITY_OR_OTHER|||||||0.0027|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0027
70881953|NCT01480076|141247380|SUPERIORITY_OR_OTHER|||||||0.6368|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6368
70881954|NCT01480076|141247380|SUPERIORITY_OR_OTHER||difference of LS means|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3358|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3358
70881955|NCT01480076|141247380|SUPERIORITY_OR_OTHER||difference of LS means|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.5089|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5089
70881956|NCT01480076|141247380|SUPERIORITY_OR_OTHER|||||||0.0141|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0141
70881957|NCT01480076|141247380|SUPERIORITY_OR_OTHER|||||||0.428|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4280
70881958|NCT01480076|141247380|SUPERIORITY_OR_OTHER|||||||0.0002|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0002
70881959|NCT01480076|141247380|SUPERIORITY_OR_OTHER|||||||0.3827|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3827
70881960|NCT01480076|141247380|SUPERIORITY_OR_OTHER||difference of LS means|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.0748|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0748
70881961|NCT01480076|141247380|SUPERIORITY_OR_OTHER||least squares mean|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.5663|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5663
70881962|NCT01480076|141247381|SUPERIORITY_OR_OTHER|||||||0.1544|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1544
70881963|NCT01480076|141247381|SUPERIORITY_OR_OTHER|||||||0.0167|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0167
70881964|NCT01480076|141247381|SUPERIORITY_OR_OTHER|||||||0.3868|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3868
70881965|NCT01480076|141247381|SUPERIORITY_OR_OTHER|||||||0.2214|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2214
70881966|NCT01480076|141247381|SUPERIORITY_OR_OTHER||difference of LS means|8.9|STANDARD_ERROR_OF_MEAN|4.96||0.0743|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0743
70881967|NCT01480076|141247381|SUPERIORITY_OR_OTHER||difference of LS means|-17.2|STANDARD_ERROR_OF_MEAN|12.22||0.1601|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1601
70881968|NCT01480076|141247381|SUPERIORITY_OR_OTHER|||||||0.1251|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1251
70881969|NCT01480076|141247381|SUPERIORITY_OR_OTHER|||||||0.1764|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1764
70881970|NCT01480076|141247381|SUPERIORITY_OR_OTHER|||||||0.5528|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5528
70881971|NCT01480076|141247381|SUPERIORITY_OR_OTHER|||||||0.108|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1080
70881972|NCT01480076|141247381|SUPERIORITY_OR_OTHER||difference of LS means|4.6|STANDARD_ERROR_OF_MEAN|6.27||0.4644|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4644
70881973|NCT01480076|141247381|SUPERIORITY_OR_OTHER||difference of LS means|-30.6|STANDARD_ERROR_OF_MEAN|17.91||0.0887|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0887
70881974|NCT01480076|141247381|SUPERIORITY_OR_OTHER|||||||0.0071|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0071
70881975|NCT01480076|141247381|SUPERIORITY_OR_OTHER|||||||0.064|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0640
70881976|NCT01480076|141247381|SUPERIORITY_OR_OTHER|||||||0.1552|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1552
70881977|NCT01480076|141247381|SUPERIORITY_OR_OTHER|||||||0.5979|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5979
70881978|NCT01480076|141247381|SUPERIORITY_OR_OTHER||difference of LS means|4.3|STANDARD_ERROR_OF_MEAN|5.58||0.4444|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4444
70881979|NCT01480076|141247381|SUPERIORITY_OR_OTHER||difference of LS means|-10.7|STANDARD_ERROR_OF_MEAN|12.27||0.3863|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3863
70881980|NCT01480076|141247381|SUPERIORITY_OR_OTHER|||||||0.6352|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6352
70881981|NCT01480076|141247381|SUPERIORITY_OR_OTHER|||||||0.1265|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1265
70881982|NCT01480076|141247381|SUPERIORITY_OR_OTHER|||||||0.6161|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6161
70881983|NCT01480076|141247381|SUPERIORITY_OR_OTHER|||||||0.528|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5280
70881984|NCT01480076|141247381|SUPERIORITY_OR_OTHER||difference of LS means|11.5|STANDARD_ERROR_OF_MEAN|8.51||0.1769|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1769
70881985|NCT01480076|141247381|SUPERIORITY_OR_OTHER||difference of LS means|-16.0|STANDARD_ERROR_OF_MEAN|22.24||0.4743|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4743
70881986|NCT01480076|141247381|SUPERIORITY_OR_OTHER|||||||0.6901|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6901
70881987|NCT01480076|141247381|SUPERIORITY_OR_OTHER|||||||0.0245|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0245
70881988|NCT01480076|141247381|SUPERIORITY_OR_OTHER|||||||0.7707|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7707
70881989|NCT01480076|141247381|SUPERIORITY_OR_OTHER|||||||0.4989|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4989
70881990|NCT01480076|141247381|SUPERIORITY_OR_OTHER||difference of LS means|15.2|STANDARD_ERROR_OF_MEAN|7.31||0.0387|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0387
70881991|NCT01480076|141247381|SUPERIORITY_OR_OTHER||difference of LS means|-11.7|STANDARD_ERROR_OF_MEAN|15.88||0.4635|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4635
70881992|NCT01480076|141247382|SUPERIORITY_OR_OTHER|||||||0.1392|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1392
70881993|NCT01480076|141247382|SUPERIORITY_OR_OTHER|||||||0.1448|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1448
70881994|NCT01480076|141247382|SUPERIORITY_OR_OTHER|||||||0.0187|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0187
70881995|NCT01480076|141247382|SUPERIORITY_OR_OTHER|||||||0.292|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2920
70881996|NCT01480076|141247382|SUPERIORITY_OR_OTHER||difference of LS means|4.2|STANDARD_ERROR_OF_MEAN|4.95||0.3968|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3968
70881997|NCT01480076|141247382|SUPERIORITY_OR_OTHER||difference of LS means|5.1|STANDARD_ERROR_OF_MEAN|10.95||0.642|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6420
70881998|NCT01480076|141247382|SUPERIORITY_OR_OTHER|||||||0.01|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0100
70881999|NCT01480076|141247382|SUPERIORITY_OR_OTHER|||||||0.8634|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8634
70882000|NCT01480076|141247382|SUPERIORITY_OR_OTHER|||||||0.0134|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0134
70882001|NCT01480076|141247382|SUPERIORITY_OR_OTHER|||||||0.8147|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8147
70882002|NCT01480076|141247382|SUPERIORITY_OR_OTHER||difference of LS means|-5.1|STANDARD_ERROR_OF_MEAN|6.06||0.4035|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4035
70882003|NCT01480076|141247382|SUPERIORITY_OR_OTHER||difference of LS means|-4.8|STANDARD_ERROR_OF_MEAN|14.25||0.7385|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7385
70882004|NCT01480076|141247382|SUPERIORITY_OR_OTHER|||||||0.0139|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0139
70882005|NCT01480076|141247382|SUPERIORITY_OR_OTHER|||||||0.5207|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5207
70882006|NCT01480076|141247382|SUPERIORITY_OR_OTHER|||||||0.0091|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0091
70882007|NCT01480076|141247382|SUPERIORITY_OR_OTHER|||||||0.2312|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2312
70882008|NCT01480076|141247382|SUPERIORITY_OR_OTHER||difference of LS means|-1.8|STANDARD_ERROR_OF_MEAN|5.89||0.7578|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7578
70882009|NCT01480076|141247382|SUPERIORITY_OR_OTHER||difference of LS means|7.9|STANDARD_ERROR_OF_MEAN|13.42||0.5575|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5575
70882010|NCT01480076|141247382|SUPERIORITY_OR_OTHER|||||||0.4486|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4486
70882011|NCT01480076|141247382|SUPERIORITY_OR_OTHER|||||||0.0102|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0102
70882012|NCT01480076|141247382|SUPERIORITY_OR_OTHER|||||||0.1185|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1185
70882013|NCT01480076|141247382|SUPERIORITY_OR_OTHER|||||||0.7523|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7523
70963125|NCT01009554|141430762|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.062|STANDARD_ERROR_OF_MEAN|0.0491||0.21|TWO_SIDED|95.0|-0.036|0.16||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.160|-0.036|0.210
70882014|NCT01480076|141247382|SUPERIORITY_OR_OTHER||difference of LS means|17.1|STANDARD_ERROR_OF_MEAN|7.38||0.0214|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0214
70882015|NCT01480076|141247382|SUPERIORITY_OR_OTHER||difference of LS means|0.4|STANDARD_ERROR_OF_MEAN|19.12||0.9826|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9826
70882016|NCT01480076|141247382|SUPERIORITY_OR_OTHER|||||||0.6627|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6627
70882017|NCT01480076|141247382|SUPERIORITY_OR_OTHER|||||||0.4674|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4674
70882018|NCT01480076|141247382|SUPERIORITY_OR_OTHER|||||||0.2965|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2965
70882019|NCT01480076|141247382|SUPERIORITY_OR_OTHER|||||||0.1778|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1778
70882020|NCT01480076|141247382|SUPERIORITY_OR_OTHER||difference of LS means|6.6|STANDARD_ERROR_OF_MEAN|7.65||0.3903|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3903
70882021|NCT01480076|141247382|SUPERIORITY_OR_OTHER||difference of LS means|16.8|STANDARD_ERROR_OF_MEAN|15.53||0.2794|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2794
70882022|NCT01480076|141247383|SUPERIORITY_OR_OTHER|||||||0.0628|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0628
70882023|NCT01480076|141247383|SUPERIORITY_OR_OTHER|||||||0.1166|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1166
70882024|NCT01480076|141247383|SUPERIORITY_OR_OTHER|||||||0.0451|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0451
70882025|NCT01480076|141247383|SUPERIORITY_OR_OTHER|||||||0.9327|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9327
70882026|NCT01480076|141247383|SUPERIORITY_OR_OTHER||difference of LS means|5.1|STANDARD_ERROR_OF_MEAN|6.28||0.4177|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4177
70882027|NCT01480076|141247383|SUPERIORITY_OR_OTHER||difference of LS means|-7.9|STANDARD_ERROR_OF_MEAN|14.64||0.5885|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5885
70882028|NCT01480076|141247383|SUPERIORITY_OR_OTHER|||||||0.0059|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0059
70882029|NCT01480076|141247383|SUPERIORITY_OR_OTHER|||||||0.3467|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3467
70882030|NCT01480076|141247383|SUPERIORITY_OR_OTHER|||||||0.0654|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0654
70882031|NCT01480076|141247383|SUPERIORITY_OR_OTHER|||||||0.3965|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3965
70882032|NCT01480076|141247383|SUPERIORITY_OR_OTHER||difference of LS means|-1.3|STANDARD_ERROR_OF_MEAN|7.11||0.8548|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8548
70882033|NCT01480076|141247383|SUPERIORITY_OR_OTHER||difference of LS means|-25.1|STANDARD_ERROR_OF_MEAN|21.35||0.2405|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2405
70882034|NCT01480076|141247383|SUPERIORITY_OR_OTHER|||||||0.0056|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0056
70882035|NCT01480076|141247383|SUPERIORITY_OR_OTHER|||||||0.8105|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8105
70882036|NCT01480076|141247383|SUPERIORITY_OR_OTHER|||||||0.047|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0470
70882037|NCT01480076|141247383|SUPERIORITY_OR_OTHER|||||||0.6067|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6067
70882038|NCT01480076|141247383|SUPERIORITY_OR_OTHER||difference of LS means|-6.0|STANDARD_ERROR_OF_MEAN|7.56||0.4309|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4309
70882039|NCT01480076|141247383|SUPERIORITY_OR_OTHER||difference of LS means|0.5|STANDARD_ERROR_OF_MEAN|16.09||0.9761|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9761
70882040|NCT01480076|141247383|SUPERIORITY_OR_OTHER|||||||0.6261|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6261
70882041|NCT01480076|141247383|SUPERIORITY_OR_OTHER|||||||0.086|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0860
70882042|NCT01480076|141247383|SUPERIORITY_OR_OTHER|||||||0.2884|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2884
70882043|NCT01480076|141247383|SUPERIORITY_OR_OTHER|||||||0.8854|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8854
70882044|NCT01480076|141247383|SUPERIORITY_OR_OTHER||difference of LS means|16.9|STANDARD_ERROR_OF_MEAN|10.88||0.1226|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1226
70882045|NCT01480076|141247383|SUPERIORITY_OR_OTHER||difference of LS means|-9.2|STANDARD_ERROR_OF_MEAN|26.07||0.7249|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7249
70882046|NCT01480076|141247383|SUPERIORITY_OR_OTHER|||||||0.5129|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5129
70882047|NCT01480076|141247383|SUPERIORITY_OR_OTHER|||||||0.1138|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1138
70882048|NCT01480076|141247383|SUPERIORITY_OR_OTHER|||||||0.1086|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1086
70882049|NCT01480076|141247383|SUPERIORITY_OR_OTHER|||||||0.5746|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5746
70882050|NCT01480076|141247383|SUPERIORITY_OR_OTHER||difference of LS means|10.8|STANDARD_ERROR_OF_MEAN|8.07||0.1831|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1831
70882051|NCT01480076|141247383|SUPERIORITY_OR_OTHER||difference of LS means|2.1|STANDARD_ERROR_OF_MEAN|15.54||0.8917|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8917
70882052|NCT01480076|141247384|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70882053|NCT01480076|141247384|SUPERIORITY_OR_OTHER|||||||0.1152|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1152
70882054|NCT01480076|141247384|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70882055|NCT01480076|141247384|SUPERIORITY_OR_OTHER|||||||0.4578|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4578
70882056|NCT01480076|141247384|SUPERIORITY_OR_OTHER||difference of LS means|-6.4|STANDARD_ERROR_OF_MEAN|2.56||0.0125|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0125
70882057|NCT01480076|141247384|SUPERIORITY_OR_OTHER||difference of LS means|-10.2|STANDARD_ERROR_OF_MEAN|4.23||0.0158|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0158
70882058|NCT01480076|141247384|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70882059|NCT01480076|141247384|SUPERIORITY_OR_OTHER|||||||0.2894|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2894
70882060|NCT01480076|141247384|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70882061|NCT01480076|141247384|SUPERIORITY_OR_OTHER|||||||0.723|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7230
70882062|NCT01480076|141247384|SUPERIORITY_OR_OTHER||difference of LS means|-9.3|STANDARD_ERROR_OF_MEAN|3.2||0.0038|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0038
70882063|NCT01480076|141247384|SUPERIORITY_OR_OTHER||difference of LS means|-13.9|STANDARD_ERROR_OF_MEAN|5.37||0.0097|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0097
70882064|NCT01480076|141247384|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70882065|NCT01480076|141247384|SUPERIORITY_OR_OTHER|||||||0.0628|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0628
70882066|NCT01480076|141247384|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70882067|NCT01480076|141247384|SUPERIORITY_OR_OTHER|||||||0.9232|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9232
70882068|NCT01480076|141247384|SUPERIORITY_OR_OTHER||difference of LS means|-5.2|STANDARD_ERROR_OF_MEAN|3.37||0.1249|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1249
70882069|NCT01480076|141247384|SUPERIORITY_OR_OTHER||difference of LS means|-14.1|STANDARD_ERROR_OF_MEAN|5.42||0.0093|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0093
70963126|NCT01009554|141430763|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.262|STANDARD_ERROR_OF_MEAN|0.055|<|0.001|TWO_SIDED|95.0|0.153|0.372||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.372|0.153|<0.001
70963127|NCT01009554|141430764|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.281|STANDARD_ERROR_OF_MEAN|0.0654|<|0.001|TWO_SIDED|95.0|0.151|0.411||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.411|0.151|<0.001
70963128|NCT01009554|141430765|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.066|STANDARD_ERROR_OF_MEAN|0.0496||0.187|TWO_SIDED|95.0|-0.033|0.165||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.165|-0.033|0.187
70963129|NCT01009554|141430766|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.256|STANDARD_ERROR_OF_MEAN|0.0544|<|0.001|TWO_SIDED|95.0|0.148|0.364||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.364|0.148|<0.001
70963130|NCT01009554|141430767|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.273|STANDARD_ERROR_OF_MEAN|0.0669|<|0.001|TWO_SIDED|95.0|0.14|0.406||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.406|0.140|<0.001
70963131|NCT01405937|141430773|SUPERIORITY_OR_OTHER||||||<|0.001||||||The Type-I error rate over the multiple tests comparisons was controlled by the Hochberg testing procedure.|exact test for binomial proportion|||The null hypothesis that the percentage of participants achieving SVR24 of vaniprevir treatment was 20% versus the alternative that the percentage of participants achieving SVR24 of vaniprevir treatment was over 20% was tested.||||<0.001
70882070|NCT01480076|141247384|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70963132|NCT01405937|141430773|SUPERIORITY_OR_OTHER||||||<|0.001||||||The Type-I error rate over the multiple tests comparisons was controlled by the Hochberg testing procedure.|exact test for binomial proportion|||The null hypothesis that the percentage of participants achieving SVR24 of vaniprevir treatment was 20% versus the alternative that the percentage of participants achieving SVR24 of vaniprevir treatment was over 20% was tested.||||<0.001
70963133|NCT03829319|141430795|OTHER||Hazard Ratio (HR)|0.88||||0.07976|TWO_SIDED|95.0|0.74|1.05|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.05|0.74|0.07976
70963134|NCT03829319|141430796|OTHER||Hazard Ratio (HR)|1.05||||0.70818|TWO_SIDED|95.0|0.88|1.26|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.26|0.88|0.70818
70963135|NCT03829319|141430797|OTHER||Percent Difference|6.3||||0.08643|TWO_SIDED|95.0|-2.8|15.4|||Stratified Miettinen & Nurminen|One-sided p-value for testing. H0: difference in percent = 0 versus H1: difference in percent \> 0.||Comparison based on Miettinen \& Nurminen method stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50% ).||15.4|-2.8|0.08643
70963136|NCT03829319|141430801|OTHER||Difference in Least Square Means|-1.01||||0.4805|TWO_SIDED|95.0|-3.83|1.8|||t-test, 2 sided|||Comparision based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (baseline ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status ( \<50% versus ≥50%)) as covariates.||1.80|-3.83|0.4805
70963137|NCT03829319|141430802|OTHER||Difference in Least Square Means|-0.29||||0.8747|TWO_SIDED|95.0|-3.95|3.36|||t-test, 2 sided|||Comparision based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (baseline ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status ( \<50% versus ≥50%)) as covariates.||3.36|-3.95|0.8747
70963138|NCT03829319|141430803|OTHER||Difference in Least Square Means|-0.91||||0.5941|TWO_SIDED|95.0|-4.24|2.43|||t-test, 2 sided|||Comparision based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (baseline ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (\<50% versus ≥50%)) as covariates.||2.43|-4.24|0.5941
70882071|NCT01480076|141247384|SUPERIORITY_OR_OTHER|||||||0.0937|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0937
70882072|NCT01480076|141247384|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70882073|NCT01480076|141247384|SUPERIORITY_OR_OTHER|||||||0.7814|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7814
70882074|NCT01480076|141247384|SUPERIORITY_OR_OTHER||difference of LS means|-3.9|STANDARD_ERROR_OF_MEAN|3.47||0.2561|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2561
70882075|NCT01480076|141247384|SUPERIORITY_OR_OTHER||difference of LS means|-13.6|STANDARD_ERROR_OF_MEAN|6.07||0.0255|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0255
70882076|NCT01480076|141247384|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70882077|NCT01480076|141247384|SUPERIORITY_OR_OTHER|||||||0.7241|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7241
70882078|NCT01480076|141247384|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
70882079|NCT01480076|141247384|SUPERIORITY_OR_OTHER|||||||0.0427|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0427
70882080|NCT01480076|141247384|SUPERIORITY_OR_OTHER||difference of LS means|-7.2|STANDARD_ERROR_OF_MEAN|3.67||0.0498|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0498
70882081|NCT01480076|141247384|SUPERIORITY_OR_OTHER||difference of LS means|0.7|STANDARD_ERROR_OF_MEAN|5.95||0.9078|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9078
70963139|NCT03829319|141430804|OTHER||covariate|-2.16||||0.3115|TWO_SIDED|95.0|-6.36|2.03|||t-test, 2 sided|||Comparision based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (baseline ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status ( \<50% versus ≥50%)) as covariates.||2.03|-6.36|0.3115
70963140|NCT03829319|141430805|OTHER||covariate|-0.37||||0.8134|TWO_SIDED|95.0|-3.47|2.72|||t-test, 2 sided|||Comparision based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (baseline ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status ( \<50% versus ≥50%)) as covariates.||2.72|-3.47|0.8134
70882082|NCT00909779|141247418|NON_INFERIORITY_OR_EQUIVALENCE|"The study was powered under a one-sided alternative hypothesis, in which arformoterol is superior to placebo, with a hazard ratio of 0.80 or less. To achieve 80% power, it was necessary to observe 86 total events for the primary endpoint adjusted for interim analysis. Assuming an annual event proportion of 17.3% in the placebo group and 30% lost to follow-up, we anticipated to randomize approximately 900 subjects (450 per arm).~The non-inferiority margin for the hazard ratio is 1.4."|Hazard Ratio (HR)|0.606|||||TWO_SIDED|95.0|0.425|0.864|||Regression, Cox||Hazard ratio was calculated as arformoterol vs. placebo.|"The null hypothesis is: There is 40% or higher excess risk of the primary events in the arformoterol group relative to placebo (a constant hazard ratio of 1.4).~The primary analysis was a Cox proportional hazards regression model, with treatment group, baseline smoking status, sex, age, BMI, and baseline FEV1 as covariates. The hazard ratio and 90% two-sided confidence interval for the hazard ratio (adjusted for the interim analysis) comparing arformoterol to placebo were estimated."||0.864|0.425|
70882083|NCT00117559|141247427|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<.05
70882084|NCT02016482|141247428|SUPERIORITY_OR_OTHER||Difference in percentage|43.2|||<|0.001|TWO_SIDED|95.0|32.8|53.6||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||For US regulatory purposes, ranked first secondary endpoint.||53.6|32.8|< 0.001
70882085|NCT02016482|141247429|SUPERIORITY_OR_OTHER||Difference in percentage|42.0|||<|0.001|TWO_SIDED|95.0|30.8|53.2||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||Ranked sixth secondary endpoint. For US regulatory purposes, this was the primary endpoint.||53.2|30.8|< 0.001
70882086|NCT02016482|141247430|SUPERIORITY_OR_OTHER||LS Mean|-44.8|||<|0.001|TWO_SIDED|95.0|-53.5|-36.0||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Ranked first secondary endpoint. For US regulatory purposes, ranked second secondary endpoint.||-36.0|-53.5|< 0.001
70882087|NCT02016482|141247431|SUPERIORITY_OR_OTHER||Difference in percentage|6.6||||0.008|TWO_SIDED|95.0|1.8|11.3||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||Ranked second secondary endpoint. For US regulatory purposes, ranked third secondary endpoint.||11.3|1.8|0.008
70882088|NCT02016482|141247432|SUPERIORITY_OR_OTHER||LS Mean Percent Change|-2.6|||<|0.001|TWO_SIDED|95.0|-3.3|-2.0||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Ranked third secondary endpoint. For US regulatory purposes, ranked fourth secondary endpoint.||-2.0|-3.3|< 0.001
70882089|NCT02016482|141247433|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.9|||<|0.001|TWO_SIDED|95.0|-3.6|-2.2||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Ranked fourth secondary endpoint. For US regulatory purposes, ranked fifth secondary endpoint.||-2.2|-3.6|< 0.001
70882090|NCT02016482|141247434|SUPERIORITY_OR_OTHER||Difference in percentage|57.9||||0.002|TWO_SIDED|95.0|33.8|82.0||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||Ranked fifth secondary endpoint. For US regulatory purposes, ranked sixth secondary endpoint.||82.0|33.8|0.002
70882091|NCT02016482|141247435|SUPERIORITY_OR_OTHER||Difference in percentage|43.3|||<|0.001|TWO_SIDED|95.0|31.3|55.2||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||55.2|31.3|< 0.001
70882092|NCT02016482|141247436|SUPERIORITY_OR_OTHER||Difference in percentage|44.8|||<|0.001|TWO_SIDED|95.0|33.2|56.5||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||56.5|33.2|< 0.001
70882093|NCT02016482|141247437|SUPERIORITY_OR_OTHER||Difference in percentage|18.6|||<|0.001|TWO_SIDED|95.0|10.6|26.6||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||26.6|10.6|< 0.001
70882094|NCT02016482|141247438|SUPERIORITY_OR_OTHER||Difference in percentage|36.0|||<|0.001|TWO_SIDED|95.0|25.0|46.9||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||46.9|25.0|< 0.001
70882095|NCT02016482|141247439|SUPERIORITY_OR_OTHER||Difference in percentage|13.3|||<|0.001|TWO_SIDED|95.0|6.5|20.0||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||20.0|6.5|<0.001
70882096|NCT02016482|141247440|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.5|||<|0.001|TWO_SIDED|95.0|-4.3|-2.8||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-2.8|-4.3|< 0.001
70882097|NCT02016482|141247441|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.9|||<|0.001|TWO_SIDED|95.0|-46.9|-30.8||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-30.8|-46.9|< 0.001
70882098|NCT02016482|141247442|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.6|||<|0.001|TWO_SIDED|95.0|-33.5|-23.7||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-23.7|-33.5|< 0.001
70882099|NCT02016482|141247443|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.1|||<|0.001|TWO_SIDED|95.0|-58.3|-41.9||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-41.9|-58.3|< 0.001
70882100|NCT02016482|141247444|SUPERIORITY_OR_OTHER||Difference in percentage|7.4||||0.004|TWO_SIDED|95.0|2.4|12.4||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||12.4|2.4|0.004
70882101|NCT02016482|141247445|SUPERIORITY_OR_OTHER||Difference in percentage|18.5|||<|0.001|TWO_SIDED|95.0|10.1|26.8||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||26.8|10.1|< 0.001
70882102|NCT02016482|141247446|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5|||<|0.001|TWO_SIDED|95.0|-3.1|-1.9||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-1.9|-3.1|< 0.001
70882103|NCT02016482|141247447|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.2|||<|0.001|TWO_SIDED|95.0|-50.0|-30.4||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-30.4|-50.0|< 0.001
70882104|NCT02016482|141247448|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.5|||<|0.001|TWO_SIDED|95.0|-23.6|-15.3||Across all strata, P values were calculated from ANCOVA with stratum, Baseline value, and treatment in the model.|ANCOVA|||||-15.3|-23.6|< 0.001
70882105|NCT02016482|141247449|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.1|||<|0.001|TWO_SIDED|95.0|-10.0|-6.1||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-6.1|-10.0|< 0.001
70882106|NCT02016482|141247450|SUPERIORITY_OR_OTHER||LS Mean Difference|-71.2|||<|0.001|TWO_SIDED|95.0|-87.3|-55.0||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-55.0|-87.3|< 0.001
70882107|NCT02016482|141247451|SUPERIORITY_OR_OTHER||Difference in percentage|51.1|||<|0.001|TWO_SIDED|95.0|38.6|63.5||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||PASI 75||63.5|38.6|< 0.001
70882108|NCT02016482|141247451|SUPERIORITY_OR_OTHER||Difference in percentage|52.5|||<|0.001|TWO_SIDED|95.0|39.9|65.0||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||PASI 50||65.0|39.9|< 0.001
70882109|NCT02016482|141247451|SUPERIORITY_OR_OTHER||Difference in percentage|40.9|||<|0.001|TWO_SIDED|95.0|29.0|52.9||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||PASI 90||52.9|29.0|< 0.001
70882110|NCT02016482|141247451|SUPERIORITY_OR_OTHER||Difference in percentage|26.4|||<|0.001|TWO_SIDED|95.0|15.8|36.9||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||PASI 100||36.9|15.8|< 0.001
70882111|NCT02016482|141247452|SUPERIORITY_OR_OTHER||Difference in percentage|52.2|||<|0.001|TWO_SIDED|95.0|40.8|63.7||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||63.7|40.8|< 0.001
70963141|NCT03829319|141430806|OTHER||Hazard Ratio (HR)|1.16||||0.2133|TWO_SIDED|95.0|0.92|1.47|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.47|0.92|0.2133
70882112|NCT02016482|141247453|SUPERIORITY_OR_OTHER||Difference in percentage|24.8|||<|0.001|TWO_SIDED|95.0|15.3|34.3||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||34.3|15.3|< 0.001
70882113|NCT02016482|141247454|SUPERIORITY_OR_OTHER||Difference in percentage|90.4|||<|0.001|TWO_SIDED|95.0|72.5|108.3||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||108.3|72.5|< 0.001
70882114|NCT02016482|141247455|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.1|||<|0.001|TWO_SIDED|95.0|-13.9|-8.4||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-8.4|-13.9|< 0.001
70882115|NCT02016482|141247456|SUPERIORITY_OR_OTHER||LS Mean Difference|-80.6|||<|0.001|TWO_SIDED|95.0|-97.9|-63.3||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-63.3|-97.9|< 0.001
70882116|NCT02016482|141247457|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.9|||<|0.001|TWO_SIDED|95.0|-64.0|-37.8||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-37.8|-64.0|< 0.001
70882117|NCT02016482|141247458|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.7|||<|0.001|TWO_SIDED|95.0|-73.1|-42.4||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-42.4|-73.1|< 0.001
70882118|NCT02016482|141247459|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|||<|0.001|TWO_SIDED|95.0|-1.1|-0.7||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-0.7|-1.1|< 0.001
70882119|NCT02016482|141247460|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.7|||<|0.001|TWO_SIDED|95.0|-33.9|-21.6||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-21.6|-33.9|< 0.001
70882120|NCT02016482|141247461|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.1|||<|0.001|TWO_SIDED|95.0|-7.8|-4.5||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-4.5|-7.8|< 0.001
70882121|NCT02016482|141247462|SUPERIORITY_OR_OTHER||Difference in percentage|15.7|||<|0.001|TWO_SIDED|95.0|7.1|24.3||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||DLQI = 0||24.3|7.1|< 0.001
70882122|NCT02016482|141247462|SUPERIORITY_OR_OTHER||Difference in percentage|27.1|||<|0.001|TWO_SIDED|95.0|16.7|37.4||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||DLQI = 0/1||37.4|16.7|< 0.001
70882123|NCT02016482|141247463|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.416|TWO_SIDED|95.0|-1.0|2.5||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Absenteeism||2.5|-1.0|0.416
70882124|NCT02016482|141247463|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.3|||<|0.001|TWO_SIDED|95.0|-22.9|-11.6||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Presenteeism||-11.6|-22.9|< 0.001
70882125|NCT02016482|141247463|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.2|||<|0.001|TWO_SIDED|95.0|-21.0|-9.3||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Overall work impairment||-9.3|-21.0|< 0.001
70882126|NCT02016482|141247463|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.4|||<|0.001|TWO_SIDED|95.0|-27.3|-15.4||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Activity impairment||-15.4|-27.3|< 0.001
70882127|NCT02016482|141247464|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|||<|0.001|TWO_SIDED|95.0|0.1|0.2||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||0.2|0.1|< 0.001
70882128|NCT02016482|141247465|SUPERIORITY_OR_OTHER||LS Mean Difference|5.5||||0.012|TWO_SIDED|95.0|1.2|9.8||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||9.8|1.2|0.012
70882129|NCT02016482|141247466|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1||||0.025|TWO_SIDED|95.0|-2.0|-0.1||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||HADS anxiety score||-0.1|-2.0|0.025
70882130|NCT02016482|141247466|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.3||||0.005|TWO_SIDED|95.0|-2.3|-0.4||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||HADS depression score||-0.4|-2.3|0.005
70882131|NCT02016482|141247467|SUPERIORITY_OR_OTHER||Difference in percentage|2.5||||0.164|TWO_SIDED|95.0|-0.9|6.0||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Chi-squared|||||6|-0.9|0.164
70882132|NCT02016482|141247468|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8|||<|0.001|TWO_SIDED|95.0|-3.4|-2.1||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-2.1|-3.4|< 0.001
70882133|NCT02738333|141247473|NON_INFERIORITY|A sample size of 100 participants per treatment group would provide over 90% power to establish non-inferiority in the SVR12 rates between the LDV/SOF group and SOF+RBV group. Sample size was based on the assumptions that the clinically meaningful non-inferiority margin is 10%, both groups have a SVR12 rate of 96%, and the significance level is 0.025 one-sided.|Difference in proportions|0.9|||||TWO_SIDED|95.0|-5.3|7.1|||||Difference in proportions between treatment groups and associated 95% confidence intervals (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions.|||7.1|-5.3|
70882134|NCT00791518|141247511|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2||||||95.0|0.1|0.4|||||Least squares mean differences are calculated as \<80% group minus \>=80% group and are adjusted for Investigator.|||0.4|0.1|
70882135|NCT00791518|141247512|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||||95.0|0.2|0.4|||||Least squares mean differences are calculated as \<50% group minus \>=50% group and was adjusted for Investigator.|||0.4|0.2|
70882136|NCT00791518|141247517|SUPERIORITY_OR_OTHER||Least squares mean difference|0.7||||||95.0|-0.4|1.7|||||Least squares mean differences are calculated as \<80% group minus \>=80% group and was adjusted for Investigator.|||1.7|-0.4|
70882137|NCT00791518|141247518|SUPERIORITY_OR_OTHER||Least squares mean difference|0.9||||||95.0|-0.2|2.1|||||Least squares mean differences are calculated as \<50% group minus \>=50% group and was adjusted for Investigator.|||2.1|-0.2|
70882138|NCT01520363|141247520|SUPERIORITY||Mean Difference (Net)|-1.182|STANDARD_DEVIATION|4.294||0.211|TWO_SIDED|95.0|-3.086|0.722|||t-test, 2 sided|df=21|||t= -1.291; p=.211|.722|-3.086|.211
70882139|NCT01520363|141247520|SUPERIORITY||Median Difference (Final Values)|0.043|STANDARD_ERROR_OF_MEAN|0.67||0.949|TWO_SIDED|95.0|-1.345|1.432|||t-test, 2 sided|df=22||||1.432|-1.345|.949
70882140|NCT01520363|141247521|SUPERIORITY||Mean Difference (Final Values)|0.333|STANDARD_DEVIATION|2.456||0.541|TWO_SIDED|95.0|-0.785|1.451||df=20|t-test, 2 sided|df=20|||t=0.622; p=.541|1.451|-0.785|.541
70882141|NCT01520363|141247521|SUPERIORITY||Mean Difference (Net)|-0.042|STANDARD_DEVIATION|2.956||0.946|TWO_SIDED|95.0|-1.29|1.206||df=23|t-test, 2 sided||||t=-.069; p=0.946|1.206|-1.290|.946
70882142|NCT01520363|141247522|SUPERIORITY||Mean Difference (Net)|-0.227|STANDARD_DEVIATION|3.116||0.736|TWO_SIDED|95.0|-1.609|1.154|||t-test, 2 sided|df=21|||t=-0.342; p=0.736|1.154|-1.609|.736
70882143|NCT01520363|141247522|SUPERIORITY||Mean Difference (Net)|0.409|STANDARD_DEVIATION|3.5||0.589|TWO_SIDED|95.0|-1.143|1.961|||t-test, 2 sided||||t=0.548; p=0.589|1.961|-1.143|.589
70882144|NCT01520363|141247523|SUPERIORITY||Mean Difference (Net)|-1.429|STANDARD_DEVIATION|3.203||0.05|TWO_SIDED|95.0|-2.886|0.029|||t-test, 2 sided|df=20|||t=-2.044; p=0.05|0.029|-2.886|.05
70882145|NCT01520363|141247523|SUPERIORITY||Mean Difference (Net)|0.042|STANDARD_DEVIATION|3.862||0.958|TWO_SIDED|95.0|-1.589|1.672|||t-test, 2 sided||||t=0.053; p=0.958|1.672|-1.589|0.958
70882146|NCT01520363|141247524|SUPERIORITY||Median Difference (Net)|0.227|STANDARD_DEVIATION|1.51||0.488|TWO_SIDED|95.0|-0.442|0.897|||t-test, 2 sided|df=21|||t=0.706; p=0.488|0.897|-0.442|0.488
70882147|NCT01520363|141247524|SUPERIORITY||Median Difference (Net)|0.24|STANDARD_DEVIATION|1.535||0.442|TWO_SIDED|95.0|-0.394|0.874|||t-test, 2 sided|df=24|||t=0.782; p=0.442|0.874|-0.394|0.442
70882148|NCT01520363|141247525|SUPERIORITY||Mean Difference (Net)|0.682|STANDARD_DEVIATION|2.317||0.182|TWO_SIDED|95.0|-0.346|1.709|||t-test, 2 sided|df=21|||t=1.380; p=0.182|1.709|-0.346|0.182
70882149|NCT01520363|141247525|SUPERIORITY||Mean Difference (Net)|1.16|STANDARD_DEVIATION|1.864|<|0.005|TWO_SIDED|95.0|0.391|1.929|||t-test, 2 sided|df=24|||t=3.112; p=0.005|1.929|0.391|<0.005
70882150|NCT01520363|141247526|SUPERIORITY||Mean Difference (Net)|0.091|STANDARD_DEVIATION|3.504||0.9|TWO_SIDED|95.0|-1.463|1.644|||t-test, 2 sided||||t=0.122; p=0.90|1.644|-1.463|0.90
70882151|NCT01520363|141247526|SUPERIORITY||Mean Difference (Net)|0.48|STANDARD_DEVIATION|2.551||0.356|TWO_SIDED|95.0|-0.573|1.533|||t-test, 2 sided|df=24|||t=0.941; p=0.356|1.533|-0.573|0.356
70882152|NCT01520363|141247527|SUPERIORITY||Mean Difference (Net)|0.136|STANDARD_DEVIATION|3.06||0.836|TWO_SIDED|95.0|-1.22|1.493|||t-test, 2 sided||||t=0.209; p=0.836|1.493|-1.220|0.836
70882153|NCT01520363|141247527|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_DEVIATION|2.698||0.826|TWO_SIDED|95.0|-0.993|1.233|||t-test, 2 sided|df=24|||t=0.222; p=0.826|1.233|-0.993|0.826
70882154|NCT01520363|141247528|SUPERIORITY||Mean Difference (Net)|-3.38|STANDARD_ERROR_OF_MEAN|4.18||0.42|TWO_SIDED|95.0|-11.8|5.05|||t-test, 2 sided|||||5.05|-11.80|0.42
70882155|NCT01520363|141247529|SUPERIORITY||Mean Difference (Net)|-1.03|STANDARD_ERROR_OF_MEAN|2.97|<|0.73|TWO_SIDED|95.0|-7.02|4.96|||t-test, 2 sided|||||4.96|-7.02|<0.73
70882156|NCT01520363|141247530|SUPERIORITY||Mean Difference (Net)|8.4615|STANDARD_DEVIATION|32.8016||0.371|TWO_SIDED|95.0|-11.3603|28.2834|||t-test, 2 sided|df=12|||t=0.903; p=0.371|28.2834|-11.3603|0.371
70882157|NCT01520363|141247530|SUPERIORITY||Mean Difference (Net)|4.9917|STANDARD_DEVIATION|18.0163||0.358|TWO_SIDED|95.0|-6.4553|16.4387|||t-test, 2 sided|df=11|t=0.960; p=0.358|||16.4387|-6.4553|0.358
70882158|NCT01520363|141247531|SUPERIORITY||Mean Difference (Net)|3.09412|STANDARD_DEVIATION|24.06228||0.603|TWO_SIDED|95.0|-9.27756|15.4658|||t-test, 2 sided|df=16|t=0.530; p=0.603|||15.46580|-9.27756|0.603
70882159|NCT01520363|141247531|SUPERIORITY||Mean Difference (Net)|2.42857|STANDARD_DEVIATION|11.21479||0.432|TWO_SIDED|95.0|-4.04665|8.9038|||t-test, 2 sided|df=13|t=0.810; p=0.432|||8.90380|-4.04665|0.432
70882160|NCT01520363|141247532|SUPERIORITY||Mean Difference (Net)|11.765|STANDARD_DEVIATION|26.276||0.083|TWO_SIDED|95.0|-1.745|25.275|||t-test, 2 sided|df=16|||t=1.846; p=0.083|25.275|-1.745|0.083
70882161|NCT01520363|141247532|SUPERIORITY||Mean Difference (Net)|7.5|STANDARD_DEVIATION|14.378||0.073|TWO_SIDED|95.0|-0.802|15.802|||t-test, 2 sided|df=13|||t=1.952; p=0.073|15.802|-0.802|0.073
70882162|NCT01520363|141247533|SUPERIORITY||Mean Difference (Net)|3.7474|STANDARD_DEVIATION|26.711||0.549|TWO_SIDED|95.0|-9.1269|16.6217|||t-test, 2 sided|df=18|t=0.612; p=0.549|||16.6217|-9.1269|0.549
70882163|NCT01520363|141247533|SUPERIORITY||Mean Difference (Net)|0.7143|STANDARD_DEVIATION|16.5084||0.874|TWO_SIDED|95.0|-8.8174|10.246|||t-test, 2 sided|df=13|t=0.162; p=0.874|||10.2460|-8.8174|0.874
70882164|NCT01520363|141247534|SUPERIORITY||Mean Difference (Net)|3.8167|STANDARD_DEVIATION|40.2609||0.693|TWO_SIDED|95.0|-16.2046|23.8379|||t-test, 2 sided|df=17|t=0.402; p=0.693|||23.8379|-16.2046|0.693
70882165|NCT01520363|141247534|SUPERIORITY||Mean Difference (Net)|0.84|STANDARD_DEVIATION|27.8994||0.909|TWO_SIDED|95.0|-14.6102|16.2902|||t-test, 2 sided|df=14|t=0.117; p=0.909|||16.2902|-14.6102|0.909
70882166|NCT01520363|141247535|SUPERIORITY||Mean Difference (Net)|-0.83|STANDARD_ERROR_OF_MEAN|0.64||0.21|TWO_SIDED|95.0|-2.17|0.52|||t-test, 2 sided|||||0.52|-2.17|0.21
70882167|NCT01520363|141247536|SUPERIORITY||Mean Difference (Net)|0.74|STANDARD_ERROR_OF_MEAN|0.68||0.28|TWO_SIDED|95.0|-0.66|2.15|||t-test, 2 sided|||||2.15|-0.66|0.28
70882168|NCT01272830|141247537|SUPERIORITY|||||||0.0063||||||Significance threshold p\<0.05|paired t-test|||Change from baseline data.||||0.0063
70882169|NCT01272830|141247537|SUPERIORITY||||||>|0.05||||||Significant threshold p\<0.05|paired t-test|||Changes from baseline data||||>0.05
70882170|NCT01272830|141247538|SUPERIORITY|||||||0.0226||||||Significance threshold p\<0.5|paired|||Change from baseline data (HSS pain walking)||||0.0226
70882171|NCT01272830|141247538|SUPERIORITY|||||||0.0375||||||Significance threshold P\<0.05|paired t-test|||Change from baseline data (HSS total score)||||0.0375
70882172|NCT01272830|141247538|SUPERIORITY|||||||0.0391||||||Significance threshold p\<0.05|paired t-test|||Change from baseline data (KSS knee pain)||||0.0391
70882173|NCT01272830|141247538|SUPERIORITY|||||||0.2137|||||||paired t-test|||Changes from baseline data (HSS pain walking)||||0.2137
70882174|NCT01272830|141247538|SUPERIORITY|||||||0.1312|||||||paired t-test|||Change from baseline data (HSS total score)||||0.1312
70882175|NCT01272830|141247538|SUPERIORITY|||||||0.1578|||||||paired t-test|||Change from baseline data (KSS knee pain)||||0.1578
70882176|NCT01272830|141247539|SUPERIORITY|||||||0.0083||||||Significance threshold p\<0.05|t-test|||Changes from baseline data||||0.0083
70882177|NCT01272830|141247539|SUPERIORITY||||||>|0.05||||||Significant threshold p\<0.05|paired t-test|||Change from baseline data||||>0.05
70882178|NCT01272830|141247540|SUPERIORITY|||||||0.01||||||Significance threshold p\<0.05|ANOVA|||Change from baseline data||||0.01
70882179|NCT01272830|141247540|SUPERIORITY||||||>|0.05|||||||paired t-test|Significant threshold p\<0.05||Changes from baseline data||||>0.05
70882180|NCT00579826|141247557|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.92
70882181|NCT00579826|141247558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
70882182|NCT00579826|141247559|SUPERIORITY_OR_OTHER_LEGACY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
70882183|NCT00579826|141247560|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
70882184|NCT00579826|141247561|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
70882185|NCT00620828|141247599|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Patient cohort was inclusive of patient undergoing single TKA from June 2007 to July 2008. Effect size was calculated for the numeric pain rating scale at the immediate post-operative period, 4-hour, 8-hour , 12-hour, and 24-hour time periods as a means to assess post-operative pain control.||||<0.05
70882186|NCT00620828|141247600|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||Significant differences in Fentanyl PCA pump usage across study arms were assessed for the 4-8h,8-12h,and 12h-24h time frames.||||.05
70882187|NCT00620828|141247601|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||This analysis was performed on data collected 24-hours post-operatively for patient cohort.||||.05
70882188|NCT00620828|141247602|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||Knee extension and knee flexion measured at 24-hours post-operatively for patient cohort.||||.05
70882189|NCT00620828|141247603|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|||Straight leg raise data collected at 4-hours, 8-hours, 12-hours and 24-hours post-operatively for patient cohort.||||.05
70882190|NCT02073279|141247609|SUPERIORITY||Hazard Ratio (HR)|0.45||||0.0184|TWO_SIDED|95.0|0.23|0.89|||Log Rank|||Stratified by prior therapy (B-cell depleting therapy or immunosuppressants/others) and most recent attack (first attack or relapse).||0.89|0.23|0.0184
70882191|NCT02073279|141247610|SUPERIORITY||Mean Difference (Final Values)|3.215|STANDARD_ERROR_OF_MEAN|4.178||0.4436||95.0|-5.086|11.515|||ANCOVA|ANCOVA model: treatment group as fixed effect and baseline measurements, prior therapy, most recent attack (first attack/relapse) as covariates.||||11.515|-5.086|0.4436
70882192|NCT02073279|141247611|SUPERIORITY||Mean Difference (Final Values)|2.107|STANDARD_ERROR_OF_MEAN|1.567||0.1824||95.0|-1.008|5.221|||ANCOVA|ANCOVA model included treatment group as fixed effect. Baseline measurements, prior therapy, most recent attack (first attack/relapse) as covariates.||||5.221|-1.008|0.1824
70882193|NCT00729183|141247654|SUPERIORITY_OR_OTHER||Difference in LS Means|3.49|||<|0.001|TWO_SIDED|95.0|2.66|4.32|||Longitudinal Data Analysis (LDA) Model|||A longitudinal ANCOVA was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% confidence interval (CI). The model, applied on all time points during treatment (Screening Visit \[BL\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and BL value as covariate. The weighted Least Squares (LS) mean is based on the described model. Difference in LS Means = Odancatib 50 mg minus Placebo.||4.32|2.66|<0.001
70882194|NCT00729183|141247655|SUPERIORITY_OR_OTHER||Difference in Percentage|-2.2|||||TWO_SIDED|95.0|-12.3|7.9||||||Estimated difference (versus Placebo) and CI were based on the Miettinen \& Nurminen method.||7.9|-12.3|
70882195|NCT00729183|141247656|SUPERIORITY_OR_OTHER||Difference in Percentage|4.4|||||TWO_SIDED|95.0|-3.2|12.3||||||Estimated difference (versus Placebo) and CI were based on the Miettinen \& Nurminen method.||12.3|-3.2|
70882196|NCT00729183|141247657|SUPERIORITY_OR_OTHER||Difference in LS Means|5.39|||<|0.001|TWO_SIDED|95.0|4.36|6.42|||LDA|||A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and BL value as covariate. The weighted LS mean is based on the described model. Difference in LS Means = Odancatib 50 mg minus Placebo.||6.42|4.36|<0.001
70882197|NCT00729183|141247658|SUPERIORITY_OR_OTHER||Difference in LS Means|1.57|||<|0.001|TWO_SIDED|95.0|0.88|2.25|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||2.25|0.88|<0.001
70882198|NCT00729183|141247658|SUPERIORITY_OR_OTHER||Difference in LS Means|3.32|||<|0.001|TWO_SIDED|95.0|2.39|4.26|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||4.26|2.39|<0.001
70882199|NCT00729183|141247659|SUPERIORITY_OR_OTHER||Difference in LS Means|1.48||||0.001|TWO_SIDED|95.0|0.6|2.35|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||2.35|0.60|0.001
70882200|NCT00729183|141247659|SUPERIORITY_OR_OTHER||Difference in LS Means|3.81|||<|0.001|TWO_SIDED|95.0|2.69|4.93|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||4.93|2.69|<0.001
70882201|NCT00729183|141247660|SUPERIORITY_OR_OTHER||Difference in LS Means|2.19|||<|0.001|TWO_SIDED|95.0|1.09|3.29|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||3.29|1.09|<0.001
70882202|NCT00729183|141247660|SUPERIORITY_OR_OTHER||Difference in LS Means|5.48|||<|0.001|TWO_SIDED|95.0|4.08|6.89|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||6.89|4.08|<0.001
70882203|NCT00729183|141247661|SUPERIORITY_OR_OTHER||Difference in LS Means|0.71||||0.03|TWO_SIDED|95.0|0.07|1.35|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||1.35|0.07|0.030
70882204|NCT00729183|141247661|SUPERIORITY_OR_OTHER||Difference in LS Means|1.7|||<|0.001|TWO_SIDED|95.0|0.97|2.43|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||2.43|0.97|<0.001
70882205|NCT00729183|141247662|SUPERIORITY_OR_OTHER||Difference in LS Means|1.71||||0.001|TWO_SIDED|95.0|0.69|2.73|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||2.73|0.69|0.001
70882206|NCT00729183|141247662|SUPERIORITY_OR_OTHER||Difference in LS Means|2.7|||<|0.001|TWO_SIDED|95.0|1.62|3.78|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||3.78|1.62|<0.001
70882207|NCT00729183|141247663|SUPERIORITY_OR_OTHER||Difference in LS Means|0.16||||0.697|TWO_SIDED|95.0|-0.63|0.95|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||0.95|-0.63|0.697
70882208|NCT00729183|141247663|SUPERIORITY_OR_OTHER||Difference in LS Means|1.22||||0.013|TWO_SIDED|95.0|0.27|2.18|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||2.18|0.27|0.013
70882209|NCT00729183|141247664|SUPERIORITY_OR_OTHER||Difference in LS Means|8.01|||<|0.001|TWO_SIDED|95.0|6.03|9.99|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||9.99|6.03|<0.001
70882210|NCT00729183|141247664|SUPERIORITY_OR_OTHER||Difference in LS Means|11.46|||<|0.001|TWO_SIDED|95.0|8.96|13.97|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||13.97|8.96|<0.001
70963142|NCT03829319|141430807|OTHER||Hazard Ratio (HR)|1.41||||0.0377|TWO_SIDED|95.0|1.02|1.94|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.94|1.02|0.0377
70882211|NCT00729183|141247665|SUPERIORITY_OR_OTHER||Difference in LS Means|5.68|||<|0.001|TWO_SIDED|95.0|3.77|7.58|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||7.58|3.77|<0.001
70963143|NCT03829319|141430808|OTHER||Hazard Ratio (HR)|0.87||||0.4084|TWO_SIDED|95.0|0.62|1.21|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.21|0.62|0.4084
70882212|NCT00729183|141247665|SUPERIORITY_OR_OTHER||Difference in LS Means|9.38|||<|0.001|TWO_SIDED|95.0|6.98|11.77|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||11.77|6.98|<0.001
70882213|NCT00729183|141247666|SUPERIORITY_OR_OTHER||Difference in LS Means|-54.03|||<|0.001|TWO_SIDED|95.0|-64.81|-43.26|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain geometric LS mean percent change from BL in s-CTx (back-transformation of the log-transformed fraction from BL) and its 95% CI. The model, applied on all time points during treatment (Baseline \[Randomization\], Month 6, Month 12, Month 18, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||-43.26|-64.81|<0.001
70882214|NCT00729183|141247666|SUPERIORITY_OR_OTHER||Difference in LS Means|-45.59|||<|0.001|TWO_SIDED|95.0|-62.22|-28.96|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain geometric LS mean percent change from BL in s-CTx (back-transformation of the log-transformed fraction from BL) and its 95% CI. The model, applied on all time points during treatment (Baseline \[Randomization\], Month 6, Month 12, Month 18, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||-28.96|-62.22|<0.001
70882215|NCT00729183|141247667|SUPERIORITY_OR_OTHER||Difference in LS Means|-25.34|||<|0.001|TWO_SIDED|95.0|-37.77|-12.92|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain geometric LS mean percent change from BL in s-P1NP (back-transformation of the log-transformed fraction from BL) and its 95% CI. The model, applied on all time points during treatment (Baseline \[Randomization\], Month 6, Month 12, Month 18, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and BL value as covariate. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo.||-12.92|-37.77|<0.001
70882216|NCT00729183|141247667|SUPERIORITY_OR_OTHER||Difference in LS Means|-9.07||||0.225|TWO_SIDED|95.0|-23.69|5.56|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain geometric LS mean percent change from BL in s-P1NP (back-transformation of the log-transformed fraction from BL) and its 95% CI. The model, applied on all time points during treatment (Baseline \[Randomization\], Month 6, Month 12, Month 18, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and BL value as covariate. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo.||5.56|-23.69|0.225
70882217|NCT00567892|141247701|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.944|TWO_SIDED|95.0|-6.0|4.0||All statistical tests were two-sided and were evaluated at the α = 0.05 level of significance.|Wilcoxon signed rank test|Since the assumptions of parametric tests were not met we used non-parametric tests for the analysis.||The null hypothesis for this study was the difference between the change in THI score due to active rTMS treatment and the change in THI score due to rTMS sham was not different from 0.||4|-6|0.944
70882218|NCT00567892|141247701|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.0||||0.674|TWO_SIDED|95.0|-9.0|10.0|||Wilcoxon signed rank test|The assumptions of parametric tests were not met.|All statistical tests were two-sided and were evaluated at the α = 0.05 level of significance.|The null hypothesis for this study was the difference between the change in THI score due to 4 weeks active rTMS treatment and the change in THI score due to 4 weeks rTMS sham was not different from 0.||10|-9|0.674
70882219|NCT00004888|141247704|SUPERIORITY_OR_OTHER||Overall Response Rate|0.474|||||TWO_SIDED|95.0|0.31|0.642||||||||0.642|0.31|
70882220|NCT00004888|141247704|SUPERIORITY_OR_OTHER||Overall Response Rate|0.457|||||TWO_SIDED|95.0|0.309|0.61||||||||0.61|0.309|
70882221|NCT02174848|141247727|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||This comparison is for the initial study, during which patients in the placebo-DFP group received placebo and patients in the DFP-DFP group received deferiprone.||||0.0500
70882222|NCT02174848|141247727|SUPERIORITY|||||||0.9781|||||||t-test, 2 sided|||This comparison is for the extension study, during which patients in both groups received deferiprone.||||0.9781
70882223|NCT02174848|141247728|SUPERIORITY|||||||0.0206|||||||paired t-test|||||||0.0206
70882224|NCT02174848|141247729|SUPERIORITY|||||||0.2684|||||||paired t-test|||||||0.2684
70963144|NCT03829319|141430809|OTHER||Hazard Ratio (HR)|1.04||||0.7955|TWO_SIDED|95.0|0.79|1.36|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.36|0.79|0.7955
70882225|NCT02174848|141247730|SUPERIORITY|||||||0.0821|||||||t-test, 2 sided|||This comparison is for the initial study, during which patients in the placebo-DFP group received placebo and patients in the DFP-DFP group received deferiprone||||0.0821
70882226|NCT02174848|141247730|SUPERIORITY|||||||0.5885|||||||t-test, 2 sided|||For the placebo-DFP group, the comparison is of the scores at the start vs. the end of the extension study; for the DFP-DFP group, the comparison is of the scores at the start vs. the end of the initial study||||0.5885
70882227|NCT02174848|141247731|SUPERIORITY|||||||0.3306|||||||t-test, 2 sided|||||||0.3306
70882228|NCT00644969|141247749|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.74||||0.0457|TWO_SIDED|95.0|1.03|21.78|||Regression, Logistic|||||21.78|1.03|0.0457
70882229|NCT00644969|141247750|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.18||||0.0901|TWO_SIDED|95.0|0.75|50.71|||Regression, Logistic|||||50.71|0.75|0.0901
70882230|NCT00644969|141247751|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.1524|TWO_SIDED|95.0|0.82|3.68|||Regression, Logistic|||Week 12||3.68|0.82|0.1524
70882231|NCT00644969|141247751|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.9235|TWO_SIDED|95.0|0.45|2.05|||Regression, Logistic|||Week 24||2.05|0.45|0.9235
70882232|NCT00644969|141247752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.65||||0.0077|TWO_SIDED|95.0|-6.32|-0.99|||ANCOVA||Least squares mean difference|Week 12 treatment difference||-0.99|-6.32|0.0077
70882233|NCT00644969|141247752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.9022|TWO_SIDED|95.0|-3.99|3.52|||ANCOVA||Least squares mean difference|Week 24 treatment difference||3.52|-3.99|0.9022
70963145|NCT03829319|141430811|OTHER||Hazard Ratio (HR)|1.04||||0.7191|TWO_SIDED|95.0|0.84|1.28|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.28|0.84|0.7191
70882234|NCT00277212|141247753|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.552||||0.058|TWO_SIDED|95.0|0.296|1.03||stratified Log-Rank test, controlling for type of index mood episode|Log Rank||Cox's proportional hazards model, with type of index modd episode as stratification factor, and randomized treatment group as covariate.|||1.030|0.296|0.058
70882235|NCT00277212|141247754|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.671||||0.055|TWO_SIDED|95.0|0.446|1.011||p-value for equality of survival curves|Log Rank|stratified log-rank test, controlling for type of index mood episode|aripiprazole/placebo; Cox's proportional hazards model, with type of index mood episode as stratification facto, and randomized treatment group as covariate.|||1.011|0.446|0.055
70882236|NCT00277212|141247755|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.784||||0.381|TWO_SIDED|95.0|0.454|1.354||p-value for equality of survival curves|Log Rank|stratified log-rank test, conrolling for type of index mood episode|aripiprazole/placebo; Cox's proportional hazards model, with type of index mood episode as stratification facto, and randomized treatment group as covariate.|||1.354|0.454|0.381
70882237|NCT00277212|141247756|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.871||||0.295|TWO_SIDED|95.0|0.672|1.128||p-value for equality of survival curves|Log Rank|stratified Log-Rank Test, controlling for type of index mood episode|aripiprazole/placebo; Cox's proportional hazards model, with type of index mood episode as stratification facto, and randomized treatment group as covariate.|||1.128|0.672|0.295
70882238|NCT00277212|141247758|SUPERIORITY_OR_OTHER||Treatement Difference|2.24||||0.001|TWO_SIDED|95.0|0.91|3.57||ANOVA (main effects=double-blind treatment, covariate=index mood episode) used for baseline comparisons. ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons|ANCOVA||Aripiprazole vs. placebo|Week 52 LOCF||3.57|0.91|0.001
70882239|NCT00277212|141247759|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.56||||0.073|TWO_SIDED|95.0|0.29|1.07|||Cochran-Mantel-Haenszel||aripiprazole/placebo|Week 52 LOCF||1.07|0.29|0.073
70882240|NCT00277212|141247759|SUPERIORITY_OR_OTHER|||||||0.194||95.0|||||Cochran-Mantel-Haenszel|||At Any Time||||0.194
70882241|NCT00277212|141247760|SUPERIORITY_OR_OTHER||relative risk|3.41||||0.007|TWO_SIDED|95.0|1.3|8.94|||Cochran-Mantel-Haenszel|||Week 52 LOCF||8.94|1.30|0.007
70882242|NCT00277212|141247760|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
70882243|NCT00277212|141247761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.467|TWO_SIDED|95.0|-2.37|1.09||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA model, with double-blind treatment as main effects and index mood episode as covariate, is used for Baseline comparisons.|aripiprazole - placebo|Baseline||1.09|-2.37|0.467
70882244|NCT00277212|141247761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.36|||||TWO_SIDED|95.0|-0.06|0.78||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 12||0.78|-0.06|
70882245|NCT00277212|141247761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75|||||TWO_SIDED|95.0|0.19|1.3||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 24||1.30|0.19|
70882246|NCT00277212|141247761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.97|||||TWO_SIDED|95.0|0.08|1.86||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 36||1.86|0.08|
70882247|NCT00277212|141247761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92|||||TWO_SIDED|95.0|-0.08|1.92||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 52||1.92|-0.08|
70882248|NCT00277212|141247761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79||||0.001|TWO_SIDED|95.0|0.31|1.26||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 52 (LOCF)||1.26|0.31|0.001
70882249|NCT00277212|141247761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.002|TWO_SIDED|95.0|0.23|1.04||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Highest Change from baseline||1.04|0.23|0.002
70882250|NCT00277212|141247767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.971|TWO_SIDED|95.0|-0.35|0.34||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANOVA|ANOVA model, with double-blind treatment as main effects, is used for Baseline comparisons.|aripiprazole - placebo|Baseline||0.34|-0.35|0.971
70882251|NCT00277212|141247767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|||||TWO_SIDED|95.0|-0.03|0.51||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 8||0.51|-0.03|
70882252|NCT00277212|141247767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|||||TWO_SIDED|95.0|-0.13|0.6||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 24||0.60|-0.13|
70882253|NCT00277212|141247767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||||TWO_SIDED|95.0|-0.06|0.55||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 36||0.55|-0.06|
70882254|NCT00277212|141247767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|||||TWO_SIDED|95.0|-0.06|0.65||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 52||0.65|-0.06|
70882255|NCT00277212|141247767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.095|TWO_SIDED|95.0|-0.04|0.52||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 52 (LOCF)||0.52|-0.04|0.095
70882256|NCT00277212|141247767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.061|TWO_SIDED|95.0|-0.01|0.63||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripirazole - placebo|Highest change from Baseline||0.63|-0.01|0.061
70882257|NCT00277212|141247768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.458||95.0|-0.25|0.11||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANOVA|ANOVA model, controlling for treatment, is used for baseline estimates.|aripiprazole - placebo|Baseline||0.11|-0.25|0.458
70882258|NCT00277212|141247768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-0.05|0.26||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 8||0.26|-0.05|
70882259|NCT00277212|141247768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|||||TWO_SIDED|95.0|-0.11|0.2||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 24||0.20|-0.11|
70882260|NCT00277212|141247768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|||||TWO_SIDED|95.0|0.0|0.42||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 36||0.42|0.00|
70882261|NCT00277212|141247768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.05|0.16||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at week 52||0.16|-0.05|
70882262|NCT00277212|141247768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.515|TWO_SIDED|95.0|-0.22|0.11||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 52 (LOCF)||0.11|-0.22|0.515
70882263|NCT00277212|141247768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.73|TWO_SIDED|95.0|-0.16|0.23||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Highest Change from Baseline||0.23|-0.16|0.730
70882264|NCT00277212|141247769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.435|TWO_SIDED|95.0|-0.08|0.2||Means, mean differences, 95% confidence intervals for the differences, and the p-values are based on ANOVA/ANCOVA model.|ANOVA|ANOVA, controlling for treatment, used for baseline estimates.|aripiprazole - placebo|Baseline||0.20|-0.08|0.435
70882265|NCT00277212|141247769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|0.04|0.3||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 8||0.30|0.04|
70882266|NCT00277212|141247769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-0.11|0.17||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 24||0.17|-0.11|
70882267|NCT00277212|141247769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.13|0.13||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 36||0.13|-0.13|
70882268|NCT00277212|141247769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-0.08|0.14||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 52||0.14|-0.08|
70882269|NCT00277212|141247769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.358|TWO_SIDED|95.0|-0.06|0.17||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 52 (LOCF)||0.17|-0.06|0.358
70882270|NCT00277212|141247769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.021|TWO_SIDED|95.0|0.03|0.31||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Highest Change from Baseline||0.31|0.03|0.021
70882271|NCT03336216|141247770|SUPERIORITY||Hazard Ratio (HR)|1.47|||||TWO_SIDED|60.0|1.19|1.82||||||||1.82|1.19|
70882272|NCT03336216|141247770|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|60.0|0.77|1.3||||||||1.30|0.77|
70882273|NCT03336216|141247770|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|60.0|0.6|1.03||||||||1.03|0.60|
70963146|NCT04498832|141430812|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% Confidence Interval (CI) for the ratio of GMTs was greater than (\>) 1 between groups for each of the comparisons.|GMT ratio|2.81|||||TWO_SIDED|95.0|2.46|3.2|||||The 2-sided 95% CI was based on the student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.|A/H1N1||3.20|2.46|
70882274|NCT03336216|141247771|SUPERIORITY||Hazard Ratio (HR)|1.64|||||TWO_SIDED|60.0|1.33|2.02||||||||2.02|1.33|
70882275|NCT03336216|141247771|SUPERIORITY||Hazard Ratio (HR)|1.13||||||60.0|0.87|1.46||||||||1.46|0.87|
70882276|NCT03336216|141247771|SUPERIORITY||Hazard Ratio (HR)|0.72||||||60.0|0.55|0.94||||||||0.94|0.55|
70882277|NCT03336216|141247774|SUPERIORITY||Strata adjusted difference|1.8||||0.6537||95.0|-5.5|9.0||Stratified CMH test stratified by ECOG and prior chemotherapy|Cochran-Mantel-Haenszel||Based on Cochran-Mantel-Haenszel (CMH) method of weighting|||9.0|-5.5|0.6537
70882278|NCT03336216|141247774|SUPERIORITY||Strata adjusted difference|12.5||||0.0951||95.0|3.1|21.9||Stratified CMH test stratified by ECOG and prior chemotherapy|Cochran-Mantel-Haenszel||Based on Cochran-Mantel-Haenszel (CMH) method of weighting|||21.9|3.1|0.0951
70882279|NCT03336216|141247774|SUPERIORITY||Strata adjusted difference|5.0||||0.5171||95.0|-8.0|18.1||Stratified CMH test stratified by ECOG and prior chemotherapy|Cochran-Mantel-Haenszel||Based on Cochran-Mantel-Haenszel (CMH) method of weighting|||18.1|-8.0|0.5171
70882280|NCT03336216|141247775|SUPERIORITY||Strata adjusted difference|-0.8||||0.8505|TWO_SIDED|95.0|-9.4|7.7||Stratified CMH test stratified by ECOG and prior chemotherapy|Cochran-Mantel-Haenszel||Based on Cochran-Mantel-Haenszel (CMH) method of weighting|||7.7|-9.4|0.8505
70882281|NCT03336216|141247775|SUPERIORITY||Strata adjusted difference|1.5||||0.8144|TWO_SIDED|95.0|-9.9|12.8||Stratified CMH test stratified by ECOG and prior chemotherapy|Cochran-Mantel-Haenszel||Based on Cochran-Mantel-Haenszel (CMH) method of weighting|||12.8|-9.9|0.8144
70882282|NCT03336216|141247775|SUPERIORITY||Strata adjusted difference|0.7||||0.9087|TWO_SIDED|95.0|-10.7|12.1||Stratified CMH test stratified by ECOG and prior chemotherapy.|Cochran-Mantel-Haenszel||Based on Cochran-Mantel-Haenszel (CMH) method of weighting|||12.1|-10.7|0.9087
70882283|NCT03336216|141247778|SUPERIORITY||Cox Proportional Hazard|1.22|||||TWO_SIDED|95.0|0.76|1.96|||||Stratified Cox proportional hazard model by ECOG and type of prior chemotherapy|||1.96|0.76|
70882284|NCT03336216|141247778|SUPERIORITY||Cox Proportional Hazard|1.04|||||TWO_SIDED|95.0|0.59|1.86|||||Stratified Cox proportional hazard model by ECOG and type of prior chemotherapy|||1.86|0.59|
70882285|NCT03336216|141247778|SUPERIORITY||Cox Proportional Hazard|0.81|||||TWO_SIDED|95.0|0.45|1.46|||||Stratified Cox proportional hazard model by ECOG and type of prior chemotherapy|||1.46|0.45|
70882286|NCT01023581|141247787|SUPERIORITY_OR_OTHER||LS mean difference|-0.67|||<|0.001|TWO_SIDED|95.0|-0.96|-0.37||For each set of comparisons in the primary analysis, the null hypothesis was rejected only if both comparisons between a combination and its constituent doses were statistically significant at the 2-sided 2.5% level.|ANCOVA|ANCOVA model with treatment and geographic region as fixed effects and baseline HbA1c as a covariate.||The primary efficacy analysis consisted of 2 separate sets of comparisons between each BID combination of alogliptin and metformin (alogliptin/metformin 12.5/500 mg BID and 12.5/1000 mg BID) and its constituent doses of alogliptin and metformin. The null hypothesis was that the combination of alogliptin and metformin had no additional effect on glycemic control at Week 26 either when compared with the constituent dose of alogliptin or with the constituent dose of metformin.||-0.37|-0.96|<0.001
70882287|NCT01023581|141247787|SUPERIORITY_OR_OTHER||LS mean difference|-0.57|||<|0.001|TWO_SIDED|95.0|-0.87|-0.27|||ANCOVA|ANCOVA model with treatment and geographic region as fixed effects and baseline HbA1c as a covariate||||-0.27|-0.87|<0.001
70882288|NCT01023581|141247787|SUPERIORITY_OR_OTHER||LS mean difference|-1.0|||<|0.001|TWO_SIDED|95.0|-1.29|-0.71|||ANCOVA|ANCOVA model with treatment and geographic region as fixed effects and baseline HbA1c as a covariate.||||-0.71|-1.29|<0.001
70882289|NCT01023581|141247787|SUPERIORITY_OR_OTHER||LS mean difference|-0.44|||<|0.001|TWO_SIDED|95.0|-0.73|-0.16|||ANCOVA|ANCOVA model with treatment and geographic region as fixed effects and baseline HbA1c as a covariate.||||-0.16|-0.73|<0.001
70882290|NCT01231581|141247790|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.352|TWO_SIDED|95.0|0.66|1.32|||Log Rank||Hazard ratios are estimated using a Pike estimator.|||1.32|0.66|0.352
70882291|NCT03090100|141247810|NON_INFERIORITY|Non-inferiority margin of 10%|Difference in percentage|14.2|||<|0.001|TWO_SIDED|95.0|9.2|19.2|||z-test|||||19.2|9.2|<0.001
70882292|NCT03090100|141247810|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70882293|NCT03090100|141247811|NON_INFERIORITY|Non-inferiority margin of 10%|Difference in percentage|4.3|||<|0.001|TWO_SIDED|95.0|-0.2|8.9|||z-test|||||8.9|-0.2|<0.001
70882294|NCT03090100|141247811|SUPERIORITY|||||||0.062|||||||Cochran-Mantel-Haenszel|||||||0.062
70882295|NCT03090100|141247812|OTHER||Difference in percentage|-7.0|||||TWO_SIDED|95.0|-12.2|-1.7||||||||-1.7|-12.2|
70882296|NCT03090100|141247813|OTHER||Difference in percentage|-2.3|||||TWO_SIDED|95.0|-6.0|1.2||||||||1.2|-6.0|
70882297|NCT03090100|141247814|OTHER||Difference in percentage|9.7|||||TWO_SIDED|95.0|3.8|15.5||||||||15.5|3.8|
70963147|NCT04498832|141430812|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95%CI for the ratio of GMTs was \>1 between groups for each of the comparisons.|GMT ratio|2.25|||||TWO_SIDED|95.0|2.03|2.5|||||The 2-sided 95% CI was based on the student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.|A/H3N2-like||2.50|2.03|
70963148|NCT04498832|141430812|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95%CI for the ratio of GMTs was \>1 between groups for each of the comparisons.|GMT ratio|2.55|||||TWO_SIDED|95.0|2.31|2.81|||||The 2-sided 95% CI was based on the student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.|B/Victoria-like||2.81|2.31|
70963149|NCT04498832|141430812|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95%CI for the ratio of GMTs was \>1 between groups for each of the comparisons.|GMT ratio|3.12|||||TWO_SIDED|95.0|2.85|3.42|||||The 2-sided 95% CI was based on the student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.|B/Yamagata||3.42|2.85|
70882298|NCT03090100|141247815|OTHER||Difference in percentage|11.6|||||TWO_SIDED|95.0|5.8|17.4||||||||17.4|5.8|
70882299|NCT03090100|141247816|OTHER||Difference in percentage|9.7|||||TWO_SIDED|95.0|4.9|14.5||||||||14.5|4.9|
70882300|NCT03090100|141247817|OTHER||Difference in percentage|7.8|||||TWO_SIDED|95.0|2.3|13.2||||||||13.2|2.3|
70882301|NCT03090100|141247818|OTHER||Difference in percentage|-0.3|||||TWO_SIDED|95.0|-3.5|3.1||||||||3.1|-3.5|
70882302|NCT03090100|141247819|OTHER||Difference in percentage|-1.4|||||TWO_SIDED|95.0|-6.2|3.4||||||||3.4|-6.2|
70882303|NCT03090100|141247820|OTHER||Difference in percentage|9.8|||||TWO_SIDED|95.0|4.2|15.3||||||||15.3|4.2|
70882304|NCT03090100|141247821|OTHER||Difference in percentage|-0.1|||||TWO_SIDED|95.0|-4.2|3.9||||||||3.9|-4.2|
70882305|NCT03090100|141247822|OTHER||Difference in percentage|-0.9|||||TWO_SIDED|95.0|-5.0|3.3||||||||3.3|-5.0|
70882306|NCT05352815|141247834|SUPERIORITY|Change in HbA1c from baseline to week 52 is analysed using an analysis of covariance (ANCOVA) model with region and randomised treatment as fixed factors and baseline HbA1c as covariate. Missing HbA1c values at week 52 are imputed by using multiple imputation. Each imputed dataset is analysed separately and estimates are combined using Rubin's rules.|Treatment difference|-0.66|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.57|||ANCOVA|||||-0.57|-0.76|<0.0001
70882307|NCT02759120|141247844|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.83|TWO_SIDED|95.0|0.71|1.53|||Regression, Cox|||||1.53|0.71|0.83
70882308|NCT02759120|141247845|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.65|TWO_SIDED|95.0|0.7|1.78|||Regression, Cox|||||1.78|0.70|0.65
70882309|NCT02759120|141247846|SUPERIORITY||Hazard Ratio (HR)|1.34||||0.25|TWO_SIDED|95.0|0.82|2.17|||Regression, Cox|||||2.17|0.82|0.25
70882310|NCT02759120|141247847|SUPERIORITY||Hazard Ratio (HR)|1.36||||0.13|TWO_SIDED|95.0|0.91|2.01|||Regression, Cox|||||2.01|0.91|0.13
70882311|NCT02759120|141247848|SUPERIORITY||Risk Ratio (RR)|1.21||||0.4|TWO_SIDED|95.0|0.78|1.89|||Regression, Cox|||||1.89|0.78|0.40
70882312|NCT02759120|141247849|SUPERIORITY||Risk Ratio (RR)|1.29||||0.16|TWO_SIDED|95.0|0.9|1.83|||Regression, Cox|||||1.83|0.90|0.16
70882313|NCT02759120|141247850|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.19|TWO_SIDED|95.0|-0.56|2.83|||Regression, Cox|||||2.83|-0.56|0.19
70882314|NCT02759120|141247851|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.51|TWO_SIDED|95.0|-1.67|3.35|||Regression, Cox|||||3.35|-1.67|0.51
70882315|NCT02759120|141247852|SUPERIORITY||Risk Ratio (RR)|0.71||||0.13|TWO_SIDED|95.0|0.46|1.11|||Regression, Cox|||||1.11|0.46|0.13
70882316|NCT02759120|141247853|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.76|TWO_SIDED|95.0|-4.64|3.39|||Regression, Cox|||||3.39|-4.64|0.76
70882317|NCT02759120|141247854|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.54|TWO_SIDED|95.0|-0.24|0.46|||Regression, Cox|||||0.46|-0.24|0.54
70882318|NCT02759120|141247855|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.99|TWO_SIDED|95.0|-0.79|0.8|||Regression, Linear|||||0.80|-0.79|0.99
70882319|NCT02759120|141247856|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.76|TWO_SIDED|95.0|-4.64|3.39|||Regression, Cox|||||3.39|-4.64|0.76
70882320|NCT02759120|141247857|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.63|TWO_SIDED|95.0|-0.031|0.051|||Regression, Cox|||||0.051|-0.031|0.63
70882321|NCT02759120|141247858|SUPERIORITY||Mean Difference (Final Values)|0.018||||0.15|TWO_SIDED|95.0|-0.007|0.043|||Regression, Cox|||||0.043|-0.007|0.15
70882322|NCT02759120|141247859|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.53|TWO_SIDED|95.0|-1.11|2.15|||Regression, Cox|||||2.15|-1.11|0.53
70882323|NCT02759120|141247860|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.75|TWO_SIDED|95.0|-1.61|2.2|||Regression, Linear|||||2.20|-1.61|0.75
70882324|NCT04452331|141247919|SUPERIORITY|||||||0.06|||||||Regression, Linear|Adjusted for clinical site||Diastolic BP||||0.06
70882325|NCT04452331|141247919|SUPERIORITY|||||||0.9|||||||Regression, Linear|||Systolic BP||||0.90
70882326|NCT04452331|141247921|SUPERIORITY|||||||0.29|||||||Regression, Linear|||||||.29
70882327|NCT04452331|141247922|SUPERIORITY|||||||0.1|||||||Regression, Logistic|||||||.10
70882328|NCT04452331|141247923|SUPERIORITY|||||||0.44|||||||Regression, Linear|||||||0.44
70882329|NCT04452331|141247924|SUPERIORITY|||||||0.01|||||||Regression, Linear|||||||0.01
70882330|NCT04452331|141247925|SUPERIORITY|||||||0.01|||||||Regression, Logistic|||||||0.01
70882331|NCT04452331|141247926|SUPERIORITY|||||||0.54|||||||Regression, negative binomial|||||||0.54
70882332|NCT04452331|141247927|SUPERIORITY|||||||0.74|||||||Regression, negative binomial|||||||0.74
70882333|NCT04452331|141247928|SUPERIORITY|||||||0.03|||||||Regression, Linear|||||||0.03
70882334|NCT04452331|141247928|SUPERIORITY|||||||0.06|||||||Regression, Linear|||||||0.06
70882335|NCT04452331|141247929|SUPERIORITY||||||<|0.001|||||||Regression, negative binomial|||||||<0.001
70882336|NCT04452331|141247929|SUPERIORITY|||||||0.03|||||||Regression, negative binomial|||||||0.03
70882337|NCT04452331|141247930|SUPERIORITY||||||<|0.001|||||||Regression, poisson|||||||<0.001
70882338|NCT04452331|141247930|SUPERIORITY|||||||0.08|||||||Regression, poisson|||||||0.08
70882339|NCT04452331|141247931|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Mixed effects logistic regression including random effect of visit, to incorporate clustering of prescriptions within visits.||||||<.001
70882340|NCT04452331|141247931|SUPERIORITY|||||||0.98|||||||Mixed Models Analysis|Mixed effects logistic regression including random effect of visit, to incorporate clustering of prescriptions within visits.||||||0.98
70963150|NCT04498832|141430813|SUPERIORITY|Superiority on seroconversions was concluded if the lower limit of the 2-sided 95% CI of the difference in percentage between groups was \> 0% for each of the comparisons.|Difference in percentage|29.7|||||TWO_SIDED|95.0|25.7|33.5|||||The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.|A/H1N1||33.5|25.7|
70882341|NCT04452331|141247932|SUPERIORITY|||||||0.2|||||||Regression, Linear|||Systolic BP||||0.20
70882342|NCT04452331|141247932|SUPERIORITY|||||||0.82|||||||Regression, Linear|||Systolic BP||||0.82
70882343|NCT04452331|141247932|SUPERIORITY|||||||0.12|||||||Regression, Linear|||Diastolic BP||||0.12
70882344|NCT04452331|141247932|SUPERIORITY|||||||0.1|||||||Regression, Linear|||Diastolic BP||||0.10
70882345|NCT03760796|141247993|OTHER||Hazard Ratio (HR)|0.48||||0.018|TWO_SIDED|95.0|0.26|0.88||The a priori threshold for statistical significance was \<0.05.|Regression, Cox|Adjusting for hospital site and a propensity score inclusive of individual level baseline characteristics.||||0.88|0.26|0.018
70882346|NCT03760796|141247994|OTHER|A Markov Model of cost-effectiveness, based on 30-day readmission rates, was built to assess the Incremental Cost-Effectiveness Ratio (ICER) of adopting the Corrie Platform compared to standard of care for post AMI patients; taking into account the estimated cost of Corrie ($2,750 per patient for a 1-year use term). The reported value is a ratio of the relative cost of intervention compared to the standard of care divided by the change in the outcome, quality-adjusted life years (QALYs).|Incremental Cost-Effectiveness Ratio|-7.0|||||TWO_SIDED||||||||A negative ICER means the intervention cost is lower than the cost of standard of care, while the denominator was positive. A positive ICER means the intervention cost is greater than the cost of standard of care, while the denominator was positive.|||||
70882347|NCT03760796|141248008|OTHER||Hazard Ratio (HR)|1.45||||0.33|TWO_SIDED|95.0|0.69|2.98||The a priori threshold for statistical significance was \<0.05.|Regression, Cox|Adjusting for hospital site and a propensity score inclusive of individual level baseline characteristics.||||2.98|0.69|0.33
70882348|NCT01334723|141248050|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.38||||||95.0|0.35|0.412|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.|||0.412|0.350|
70882349|NCT01334723|141248050|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.294||||||95.0|0.235|0.368|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.|||0.368|0.235|
70882350|NCT01334723|141248051|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.613||||||95.0|0.562|0.668|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.|||0.668|0.562|
70882351|NCT01334723|141248051|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.542||||||95.0|0.427|0.689|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.|||0.689|0.427|
70882352|NCT01334723|141248052|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.519||||||95.0|0.472|0.57|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.|||0.570|0.472|
70882353|NCT01334723|141248052|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.436||||||95.0|0.333|0.57|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.|||0.570|0.333|
70882354|NCT02439320|141248096|SUPERIORITY||Odds Ratio (OR)|2.2|||<|0.001|TWO_SIDED|95.0|1.6|3.0|||Regression, Logistic|||||3.0|1.6|<0.001
70882355|NCT02439320|141248096|SUPERIORITY||Odds Ratio (OR)|2.6|||<|0.001|TWO_SIDED|95.0|2.0|3.6|||Regression, Logistic|||||3.6|2.0|<0.001
70882356|NCT02439320|141248097|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.3|2.2|||Regression, Logistic|||||2.2|1.3|<0.001
70882357|NCT02439320|141248097|SUPERIORITY||Odds Ratio, log|1.6|||<|0.001|TWO_SIDED|95.0|1.3|2.1|||Regression, Logistic|||||2.1|1.3|<0.001
70882358|NCT02439320|141248098|SUPERIORITY||Odds Ratio, log|2.4|||<|0.001|TWO_SIDED|95.0|1.8|3.1|||Regression, Logistic|||||3.1|1.8|<0.001
70882359|NCT02439320|141248098|SUPERIORITY||Odds Ratio (OR)|2.5|||<|0.001|TWO_SIDED|95.0|1.9|3.3|||Regression, Logistic|||||3.3|1.9|<0.001
70882360|NCT02439320|141248099|SUPERIORITY||Odds Ratio (OR)|1.7|||=|0.029|TWO_SIDED|95.0|1.1|2.8|||Regression, Logistic|||||2.8|1.1|=0.029
70882361|NCT02439320|141248099|SUPERIORITY||Odds Ratio (OR)|2.1|||=|0.002|TWO_SIDED|95.0|1.3|3.4|||Regression, Logistic|||||3.4|1.3|=0.002
70882362|NCT02439320|141248100|SUPERIORITY||Odds Ratio (OR)|0.4|||<|0.001|TWO_SIDED|95.0|0.3|0.5|||Regression, Logistic|||||0.5|0.3|<0.001
70882363|NCT02439320|141248100|SUPERIORITY||Odds Ratio (OR)|0.3|||<|0.001|TWO_SIDED|95.0|0.2|0.4|||Regression, Logistic|||||0.4|0.2|<0.001
70882364|NCT02439320|141248101|SUPERIORITY||Odds Ratio, log|0.7||||0.12|TWO_SIDED|95.0|0.5|1.1|||Regression, Logistic|||||1.1|0.5|0.120
70882365|NCT02439320|141248101|SUPERIORITY||Odds Ratio (OR)|0.6||||0.035|TWO_SIDED|95.0|0.4|1.0|||Regression, Logistic|||||1.0|0.4|0.035
70882366|NCT02439320|141248103|SUPERIORITY||Odds Ratio (OR)|1.1||||0.386|TWO_SIDED|95.0|0.9|1.4|||Regression, Linear|||||1.4|0.9|0.386
70882367|NCT02439320|141248103|SUPERIORITY||Odds Ratio (OR)|1.1||||0.47|TWO_SIDED|95.0|0.9|1.4|||Regression, Linear|||||1.4|0.9|0.470
70882368|NCT02439320|141248104|SUPERIORITY||Odds Ratio (OR)|1.4||||0.006|TWO_SIDED|95.0|1.1|1.8|||Regression, Logistic|||||1.8|1.1|0.006
70882369|NCT02439320|141248104|SUPERIORITY||Odds Ratio (OR)|1.3||||0.037|TWO_SIDED|95.0|1.0|1.6|||Regression, Logistic|||||1.6|1.0|0.037
70882370|NCT02439320|141248105|SUPERIORITY||Odds Ratio (OR)|1.9|||<|0.001|TWO_SIDED|95.0|1.5|2.4|||Regression, Logistic|||||2.4|1.5|<0.001
70882371|NCT02439320|141248105|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.4|2.2|||Regression, Logistic|||||02.2|1.4|<0.001
70882372|NCT02972632|141248109|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 6 relative to baseline||||<0.001
70882373|NCT02972632|141248109|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline||||<0.001
70882374|NCT02972632|141248110|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 6 relative to baseline||||<0.001
70882375|NCT02972632|141248110|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline||||<0.001
70882376|NCT02972632|141248111|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 6 relative to baseline||||<0.001
70882377|NCT02972632|141248111|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline||||<0.001
70882378|NCT02972632|141248112|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline||||<0.001
70882379|NCT02972632|141248113|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline||||<0.001
70882380|NCT02972632|141248114|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline||||<0.001
70882381|NCT02245841|141248116|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||Analysis performed was two-sided Wilcoxon signed rank test. Median differences with interquartile range are reported in outcome measure data.||||< .001
70882382|NCT02245841|141248117|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||Analysis performed was two-sided Wilcoxon signed rank test. Median differences with interquartile range are reported in outcome measure data.||||<0.001
70882383|NCT02245841|141248118|SUPERIORITY|||||||0.002|||||||Wilcoxon signed rank test|||Analysis performed was two-sided Wilcoxon signed rank test. Median differences with interquartile range are reported in outcome measure data.||||0.002
70882384|NCT02245841|141248119|SUPERIORITY|||||||0.05|||||||Wilcoxon signed rank test|||Analysis performed was two-sided Wilcoxon signed rank test. Median differences with interquartile range are reported in outcome measure data.||||0.050
70882385|NCT02245841|141248120|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||Analysis performed was two-sided Wilcoxon signed rank test. Median differences with interquartile range are reported in outcome measure data.||||<0.001
70882386|NCT01451775|141248124|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability study with standard bioequivalence range of 80% to 125%. Ratio calculated as empa 25mg fed divided by empa 25mg fasted.|Geometric mean ratio|84.04|STANDARD_DEVIATION|6.4|||TWO_SIDED|90.0|80.856|87.344|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation.|||87.344|80.856|
70882387|NCT01451775|141248124|NON_INFERIORITY_OR_EQUIVALENCE|This is an analysis of dose proportionality|Slope|0.9367|STANDARD_ERROR_OF_MEAN|0.0178|||TWO_SIDED|95.0|0.8988|0.9746||Does proportionality would be assumed if the 95% confidence interval includes one.|ANCOVA|ANCOVA with logarithm of the dose fitted as a continuous covariate and sequence, subjects within sequence, period included as categorical variables.||||0.9746|0.8988|
70882388|NCT01451775|141248125|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability study with standard bioequivalence range of 80% to 125%. Ratio calculated as empa 25mg fed divided by empa 25mg fasted.|Geometric mean ratio|63.22|STANDARD_DEVIATION|18.1|||TWO_SIDED|90.0|56.736|70.439|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation.|||70.439|56.736|
70882389|NCT01451775|141248125|NON_INFERIORITY_OR_EQUIVALENCE|This is an analysis of dose proportionality|Slope|0.9065|STANDARD_DEVIATION|0.0495|||TWO_SIDED|95.0|0.8011|1.012||Does proportionality would be assumed if the 95% confidence interval includes one.|ANCOVA|ANCOVA with logarithm of the dose fitted as a continuous covariate and sequence, subjects within sequence, period included as categorical variables.||||1.0120|0.8011|
70882390|NCT03441633|141248143|SUPERIORITY||Odds Ratio (OR)|0.74||||0|TWO_SIDED|95.0|0.68|0.82|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Non-smoker)||0.82|0.68|0.000
70882391|NCT03441633|141248143|SUPERIORITY||Odds Ratio (OR)|1.32||||0|TWO_SIDED|95.0|1.14|1.52|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Ex-smoker)||1.52|1.14|0.000
70882392|NCT03441633|141248143|SUPERIORITY||Odds Ratio (OR)|1.04||||0|TWO_SIDED|95.0|0.93|1.17|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Smoker)||1.17|0.93|0.000
70882393|NCT03441633|141248143|SUPERIORITY||Odds Ratio (OR)|0.95||||0.755|TWO_SIDED|95.0|0.8|1.13|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Non-smoker)||1.13|0.80|0.755
70882394|NCT03441633|141248143|SUPERIORITY||Odds Ratio (OR)|1.32||||0.426|TWO_SIDED|95.0|0.95|1.83|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Ex-smoker)||1.83|0.95|0.426
70882395|NCT03441633|141248143|SUPERIORITY||Odds Ratio (OR)|0.93||||0.93|TWO_SIDED|95.0|0.77|1.12|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Smoker)||1.12|0.77|0.930
70882396|NCT03441633|141248143|SUPERIORITY||Odds Ratio (OR)|0.78||||0|TWO_SIDED|95.0|0.72|0.84|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Non-smoker)||0.84|0.72|0.000
70882397|NCT03441633|141248143|SUPERIORITY||Odds Ratio (OR)|1.25||||0|TWO_SIDED|95.0|1.1|1.42|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Ex-smoker)||1.42|1.10|0.000
70882398|NCT03441633|141248143|SUPERIORITY||Odds Ratio (OR)|1.08||||0|TWO_SIDED|95.0|0.98|1.19|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Smoker)||1.19|0.98|0.000
70882399|NCT03441633|141248143|SUPERIORITY||Odds Ratio (OR)|0.98||||0.755|TWO_SIDED|95.0|0.84|1.14|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Non-smoker)||1.14|0.84|0.755
70882400|NCT03441633|141248143|SUPERIORITY||Odds Ratio (OR)|1.13||||0.426|TWO_SIDED|95.0|0.84|1.52|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Ex-smoker)||1.52|0.84|0.426
70882401|NCT03441633|141248143|SUPERIORITY||Odds Ratio (OR)|0.98||||0.93|TWO_SIDED|95.0|0.81|1.12|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Smoker)||1.12|0.81|0.930
70882402|NCT03441633|141248143|SUPERIORITY||Odds Ratio (OR)|0.79||||0|TWO_SIDED|95.0|0.74|0.84|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Non-smoker)||0.84|0.74|0.000
70882403|NCT03441633|141248143|SUPERIORITY||Odds Ratio (OR)|1.19||||0|TWO_SIDED|95.0|1.08|1.32|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Ex-smoker)||1.32|1.08|0.000
70882404|NCT03441633|141248143|SUPERIORITY||Odds Ratio (OR)|1.16||||0|TWO_SIDED|95.0|1.08|1.26|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Smoker)||1.26|1.08|0.000
70882405|NCT03441633|141248143|SUPERIORITY||Odds Ratio (OR)|0.82||||0.755|TWO_SIDED|95.0|0.6|1.13|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Non-smoker)||1.13|0.60|0.755
70882406|NCT03441633|141248143|SUPERIORITY||Odds Ratio (OR)|1.48||||0.426|TWO_SIDED|95.0|0.82|2.52|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Ex-smoker)||2.52|0.82|0.426
70882407|NCT03441633|141248143|SUPERIORITY||Odds Ratio (OR)|1.0||||0.93|TWO_SIDED|95.0|0.7|1.4|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Smoker)||1.40|0.70|0.930
70882408|NCT03441633|141248143|SUPERIORITY||Odds Ratio (OR)|0.54||||0|TWO_SIDED|95.0|0.49|0.6|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Non-smoker)||0.60|0.49|0.000
70882409|NCT03441633|141248143|SUPERIORITY||Odds Ratio (OR)|1.51||||0|TWO_SIDED|95.0|1.29|1.76|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Ex-smoker)||1.76|1.29|0.000
70882410|NCT03441633|141248143|SUPERIORITY||Odds Ratio (OR)|1.72||||0|TWO_SIDED|95.0|1.54|1.93|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Smoker)||1.93|1.54|0.000
70882411|NCT03441633|141248143|SUPERIORITY||Odds Ratio (OR)|0.91||||0.755|TWO_SIDED|95.0|0.72|1.17|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Non-smoker)||1.17|0.72|0.755
70882412|NCT03441633|141248143|SUPERIORITY||Odds Ratio (OR)|1.25||||0.426|TWO_SIDED|95.0|0.78|1.95|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Ex-smoker)||1.95|0.78|0.426
70882413|NCT03441633|141248143|SUPERIORITY||Odds Ratio (OR)|0.92||||0.93|TWO_SIDED|95.0|0.7|1.2|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Smoker)||1.20|0.70|0.930
70882414|NCT03441633|141248144|SUPERIORITY||Odds Ratio (OR)|0.99||||0|TWO_SIDED|95.0|0.9|1.09|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (No intake)||1.09|0.90|0.000
70882415|NCT03441633|141248144|SUPERIORITY||Odds Ratio (OR)|1.11||||0|TWO_SIDED|95.0|0.98|1.25|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Moderate intake)||1.25|0.98|0.000
70882416|NCT03441633|141248144|SUPERIORITY||Odds Ratio (OR)|1.52||||0.164|TWO_SIDED|95.0|0.94|2.45|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Risk consumption)||2.45|0.94|0.164
70882417|NCT03441633|141248144|SUPERIORITY||Odds Ratio (OR)|1.03||||0.826|TWO_SIDED|95.0|0.87|1.22|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (No intake)||1.22|0.87|0.826
70882418|NCT03441633|141248144|SUPERIORITY||Odds Ratio (OR)|1.16||||0.19|TWO_SIDED|95.0|0.94|1.43|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Moderate intake)||1.43|0.94|0.190
70882419|NCT03441633|141248144|SUPERIORITY||Odds Ratio (OR)|0.58||||0.526|TWO_SIDED|95.0|0.18|1.57|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Risk consumption)||1.57|0.18|0.526
70882420|NCT03441633|141248144|SUPERIORITY||Odds Ratio (OR)|0.84||||0|TWO_SIDED|95.0|0.77|0.91|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (No intake)||0.91|0.77|0.000
70882421|NCT03441633|141248144|SUPERIORITY||Odds Ratio (OR)|1.12||||0|TWO_SIDED|95.0|1.01|1.24|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Moderate intake)||1.24|1.01|0.000
70882422|NCT03441633|141248144|SUPERIORITY||Odds Ratio (OR)|1.17||||0.164|TWO_SIDED|95.0|0.76|1.83|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Risk consumption)||1.83|0.76|0.164
70882423|NCT03441633|141248144|SUPERIORITY||Odds Ratio (OR)|1.09||||0.826|TWO_SIDED|95.0|0.95|1.26|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (No intake)||1.26|0.95|0.826
70882424|NCT03441633|141248144|SUPERIORITY||Odds Ratio (OR)|0.93||||0.19|TWO_SIDED|95.0|0.77|1.13|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Moderate intake)||1.13|0.77|0.190
70882425|NCT03441633|141248144|SUPERIORITY||Odds Ratio (OR)|1.26||||0.526|TWO_SIDED|95.0|0.62|2.65|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Risk consumption)||2.65|0.62|0.526
70882426|NCT03441633|141248144|SUPERIORITY||Odds Ratio (OR)|1.36||||0|TWO_SIDED|95.0|1.28|1.45|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (No intake)||1.45|1.28|0.000
70882427|NCT03441633|141248144|SUPERIORITY||Odds Ratio (OR)|1.24||||0|TWO_SIDED|95.0|1.14|1.35|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Moderate intake)||1.35|1.14|0.000
70882428|NCT03441633|141248144|SUPERIORITY||Odds Ratio (OR)|1.36||||0.164|TWO_SIDED|95.0|0.98|1.95|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Risk consumption)||1.95|0.98|0.164
70882429|NCT03441633|141248144|SUPERIORITY||Odds Ratio (OR)|1.04||||0.826|TWO_SIDED|95.0|0.76|1.41|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (No intake)||1.41|0.76|0.826
70882430|NCT03441633|141248144|SUPERIORITY||Odds Ratio (OR)|1.22||||0.19|TWO_SIDED|95.0|0.82|1.76|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Moderate intake)||1.76|0.82|0.190
70882431|NCT03441633|141248144|SUPERIORITY||Odds Ratio (OR)|1.21||||0.526|TWO_SIDED|95.0|0.17|4.5|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Risk consumption)||4.50|0.17|0.526
70882432|NCT03441633|141248144|SUPERIORITY||Odds Ratio (OR)|1.28||||0|TWO_SIDED|95.0|1.16|1.42|||Chi-squared|||Warfarin vs. Apixaban in naive participants (No intake)||1.42|1.16|0.000
70882433|NCT03441633|141248144|SUPERIORITY||Odds Ratio (OR)|1.25||||0|TWO_SIDED|95.0|1.1|1.43|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Moderate intake)||1.43|1.10|0.000
70882434|NCT03441633|141248144|SUPERIORITY||Odds Ratio (OR)|0.92||||0.164|TWO_SIDED|95.0|0.49|1.64|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Risk consumption)||1.64|0.49|0.164
70882435|NCT03441633|141248144|SUPERIORITY||Odds Ratio (OR)|1.06||||0.826|TWO_SIDED|95.0|0.84|1.34|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (No intake)||1.34|0.84|0.826
70882436|NCT03441633|141248144|SUPERIORITY||Odds Ratio (OR)|0.91||||0.19|TWO_SIDED|95.0|0.66|1.23|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Moderate intake)||1.23|0.66|0.190
70882437|NCT03441633|141248144|SUPERIORITY||Odds Ratio (OR)|0.64||||0.526|TWO_SIDED|95.0|0.09|2.36|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Risk consumption)||2.36|0.09|0.526
70882438|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|1.36||||0|TWO_SIDED|95.0|1.2|1.53|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Quintile 1 - Urban area)||1.53|1.20|0.000
70882439|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|1.01||||0.014|TWO_SIDED|95.0|0.89|1.15|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Quintile 2 - Urban area)||1.15|0.89|0.014
70882440|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|0.87||||0|TWO_SIDED|95.0|0.77|0.99|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Quintile 3 - Urban area)||0.99|0.77|0.000
70882441|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|0.86||||0|TWO_SIDED|95.0|0.75|0.97|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Quintile 4 - Urban area)||0.97|0.75|0.000
70882442|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|0.85||||0.013|TWO_SIDED|95.0|0.74|0.97|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Quintile 5 - Urban area)||0.97|0.74|0.013
70963151|NCT04498832|141430813|SUPERIORITY|Superiority on seroconversions was concluded if the lower limit of the 2-sided 95% CI of the difference in percentage between groups was \> 0% for each of the comparisons.|Difference in percentage|28.1|||||TWO_SIDED|95.0|24.0|32.0|||||The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.|A/H3N2-like||32.0|24.0|
70882443|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|1.05||||0.157|TWO_SIDED|95.0|0.84|1.31|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Quintile 1 - Urban area)||1.31|0.84|0.157
70882444|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|1.03||||0.124|TWO_SIDED|95.0|0.82|1.29|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Quintile 2 - Urban area)||1.29|0.82|0.124
70882445|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|0.77||||0.062|TWO_SIDED|95.0|0.61|0.96|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Quintile 3 - Urban area)||0.96|0.61|0.062
70882446|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|0.98||||0.079|TWO_SIDED|95.0|0.78|1.22|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Quintile 4 - Urban area)||1.22|0.78|0.079
70882447|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|1.09||||0.14|TWO_SIDED|95.0|0.86|1.38|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Quintile 5 - Urban area)||1.38|0.86|0.140
70882448|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|1.31||||0|TWO_SIDED|95.0|1.17|1.45|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Quintile 1 - Urban area)||1.45|1.17|0.000
70882449|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|0.97||||0.014|TWO_SIDED|95.0|0.87|1.09|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Quintile 2 - Urban area)||1.09|0.87|0.014
70882450|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|1.01||||0|TWO_SIDED|95.0|0.91|1.12|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Quintile 3 - Urban area)||1.12|0.91|0.000
70882451|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|0.94||||0|TWO_SIDED|95.0|0.85|1.05|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Quintile 4 - Urban area)||1.05|0.85|0.000
70882452|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|0.83||||0.013|TWO_SIDED|95.0|0.74|0.93|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Quintile 5 - Urban area)||0.93|0.74|0.013
70882453|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|0.92||||0.157|TWO_SIDED|95.0|0.76|1.13|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Quintile 1 - Urban area)||1.13|0.76|0.157
70882454|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|0.98||||0.124|TWO_SIDED|95.0|0.81|1.2|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Quintile 2 - Urban area)||1.20|0.81|0.124
70882455|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|0.79||||0.062|TWO_SIDED|95.0|0.65|0.96|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Quintile 3 - Urban area)||0.96|0.65|0.062
70882456|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|1.23||||0.079|TWO_SIDED|95.0|1.02|1.48|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Quintile 4 - Urban area)||1.48|1.02|0.079
70882457|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|1.21||||0.14|TWO_SIDED|95.0|0.99|1.49|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Quintile 5 - Urban area)||1.49|0.99|0.140
70882458|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|0.96||||0|TWO_SIDED|95.0|0.88|1.05|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Quintile 1 - Urban area)||1.05|0.88|0.000
70882459|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|0.91||||0.014|TWO_SIDED|95.0|0.84|0.99|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Quintile 2 - Urban area)||0.99|0.84|0.014
70882460|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|0.83||||0|TWO_SIDED|95.0|0.76|0.9|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Quintile 3 - Urban area)||0.90|0.76|0.000
70882461|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|0.84||||0|TWO_SIDED|95.0|0.77|0.91|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Quintile 4 - Urban area)||0.91|0.77|0.000
70882462|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|0.92||||0.013|TWO_SIDED|95.0|0.85|1.0|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Quintile 5 - Urban area)||1.00|0.85|0.013
70882463|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|1.03||||0.157|TWO_SIDED|95.0|0.68|1.54|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Quintile 1 - Urban area)||1.54|0.68|0.157
70882464|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|0.84||||0.124|TWO_SIDED|95.0|0.53|1.29|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Quintile 2 - Urban area)||1.29|0.53|0.124
70882465|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|0.75||||0.062|TWO_SIDED|95.0|0.48|1.13|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Quintile 3 - Urban area)||1.13|0.48|0.062
70882466|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|0.88||||0.079|TWO_SIDED|95.0|0.57|1.33|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Quintile 4 - Urban area)||1.33|0.57|0.079
70882467|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|1.05||||0.14|TWO_SIDED|95.0|0.67|1.59|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Quintile 5 - Urban area)||1.59|0.67|0.140
70882468|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|0.39||||0|TWO_SIDED|95.0|0.32|0.47|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Quintile 1 - Urban area)||0.47|0.32|0.000
70882469|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|0.84||||0.014|TWO_SIDED|95.0|0.73|0.97|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Quintile 2 - Urban area)||0.97|0.73|0.014
70882470|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|1.7||||0|TWO_SIDED|95.0|1.51|1.91|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Quintile 3 - Urban area)||1.91|1.51|0.000
70882471|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|1.86||||0|TWO_SIDED|95.0|1.65|2.1|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Quintile 4 - Urban area)||2.10|1.65|0.000
70882472|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|0.94||||0.013|TWO_SIDED|95.0|0.82|1.08|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Quintile 5 - Urban area)||1.08|0.82|0.013
70882473|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|1.35||||0.157|TWO_SIDED|95.0|1.0|1.8|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Quintile 1 - Urban area)||1.80|1.00|0.157
70882474|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|1.41||||0.124|TWO_SIDED|95.0|1.04|1.88|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Quintile 2 - Urban area)||1.88|1.04|0.124
70882475|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|0.76||||0.062|TWO_SIDED|95.0|0.55|1.05|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Quintile 3 - Urban area)||1.05|0.55|0.062
70882476|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|0.92||||0.079|TWO_SIDED|95.0|0.67|1.26|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Quintile 4 - Urban area)||1.26|0.67|0.079
70963152|NCT04498832|141430813|SUPERIORITY|Superiority on seroconversions was concluded if the lower limit of the 2-sided 95% CI of the difference in percentage between groups was \> 0% for each of the comparisons.|Difference in percentage|31.4|||||TWO_SIDED|95.0|27.4|35.2|||||The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.|B/Victoria-like||35.2|27.4|
70963153|NCT04498832|141430813|SUPERIORITY|Superiority on seroconversions was concluded if the lower limit of the 2-sided 95% CI of the difference in percentage between groups was \> 0% for each of the comparisons.|Difference in percentage|35.4|||||TWO_SIDED|95.0|31.4|39.3|||||The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.|B/Yamagata||39.3|31.4|
70963154|NCT01474863|141430840|SUPERIORITY|||||||0.86|||||||ANOVA|||||||0.86
70963155|NCT03231943|141430897|OTHER||Power model|0.9476|||||TWO_SIDED|90.0|0.8982|0.9971|||||The statistical model (power model) is based on the PK parameters (AUC0-inf) from all active doses in Part 1|||0.9971|0.8982|
70882477|NCT03441633|141248145|SUPERIORITY||Odds Ratio (OR)|0.81||||0.14|TWO_SIDED|95.0|0.56|1.15|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Quintile 5 - Urban area)||1.15|0.56|0.140
70882478|NCT03441633|141248146|SUPERIORITY||Odds Ratio (OR)|1.07||||0|TWO_SIDED|95.0|0.91|1.25|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (18.5 - 25 kg per m\^2 Normal)||1.25|0.91|0.000
70882479|NCT03441633|141248146|SUPERIORITY||Odds Ratio (OR)|1.38||||0.202|TWO_SIDED|95.0|0.58|3.23|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (\<18.5 kg per m\^2 Underweight)||3.23|0.58|0.202
70882480|NCT03441633|141248146|SUPERIORITY||Odds Ratio (OR)|0.98||||0|TWO_SIDED|95.0|0.88|1.09|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (25 - 30 kg per m\^2 Overweight)||1.09|0.88|0.000
70882481|NCT03441633|141248146|SUPERIORITY||Odds Ratio (OR)|0.84||||0.003|TWO_SIDED|95.0|0.76|0.93|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (\>30 kg per m\^2 Obese)||0.93|0.76|0.003
70882482|NCT03441633|141248146|SUPERIORITY||Odds Ratio (OR)|0.82||||0.083|TWO_SIDED|95.0|0.66|1.03|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (18.5 - 25 kg per m\^2 Normal)||1.03|0.66|0.083
70882483|NCT03441633|141248146|SUPERIORITY||Odds Ratio (OR)|1.99||||0.011|TWO_SIDED|95.0|0.68|6.18|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (\<18.5 kg per m\^2 Underweight)||6.18|0.68|0.011
70882484|NCT03441633|141248146|SUPERIORITY||Odds Ratio (OR)|0.89||||0.227|TWO_SIDED|95.0|0.75|1.06|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (25 - 30 kg per m\^2 Overweight)||1.06|0.75|0.227
70882485|NCT03441633|141248146|SUPERIORITY||Odds Ratio (OR)|1.23||||0|TWO_SIDED|95.0|1.03|1.47|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (\>30 kg per m\^2 Obese)||1.47|1.03|0.000
70882486|NCT03441633|141248146|SUPERIORITY||Odds Ratio (OR)|1.01||||0|TWO_SIDED|95.0|0.88|1.16|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (18.5 - 25 kg per m\^2 Normal)||1.16|0.88|0.000
70882487|NCT03441633|141248146|SUPERIORITY||Odds Ratio (OR)|1.22||||0.202|TWO_SIDED|95.0|0.58|2.66|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (\<18.5 kg per m\^2 Underweight)||2.66|0.58|0.202
70882488|NCT03441633|141248146|SUPERIORITY||Odds Ratio (OR)|0.95||||0|TWO_SIDED|95.0|0.87|1.04|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (25 - 30 kg per m\^2 Overweight)||1.04|0.87|0.000
70882489|NCT03441633|141248146|SUPERIORITY||Odds Ratio (OR)|0.87||||0.003|TWO_SIDED|95.0|0.8|0.95|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (\>30 kg per m\^2 Obese)||0.95|0.80|0.003
70963156|NCT03231943|141430898|OTHER||Power model|0.928|||||TWO_SIDED|90.0|0.8877|0.9683|||||The statistical model (power model) is based on the PK parameters (AUC0-24) from all active doses in Part 1|||0.9683|0.8877|
70963157|NCT03231943|141430899|OTHER||Power Model|0.9352|||||TWO_SIDED|90.0|0.897|0.9734|||||The statistical model (power model) is based on the PK parameters (Cmax) from all active doses in Part 1|||0.9734|0.8970|
70882490|NCT03441633|141248146|SUPERIORITY||Odds Ratio (OR)|0.97||||0.083|TWO_SIDED|95.0|0.8|1.17|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (18.5 - 25 kg per m\^2 Normal)||1.17|0.80|0.083
70882491|NCT03441633|141248146|SUPERIORITY||Odds Ratio (OR)|0.06||||0.011|TWO_SIDED|95.0|0.02|1.05|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (\<18.5 kg per m\^2 Underweight)||1.05|0.02|0.011
70882492|NCT03441633|141248146|SUPERIORITY||Odds Ratio (OR)|0.84||||0.227|TWO_SIDED|95.0|0.72|0.98|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (25 - 30 kg per m\^2 Overweight)||0.98|0.72|0.227
70882493|NCT03441633|141248146|SUPERIORITY||Odds Ratio (OR)|1.16||||0|TWO_SIDED|95.0|0.99|1.35|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (\>30 kg per m\^2 Obese)||1.35|0.99|0.000
70882494|NCT03441633|141248146|SUPERIORITY||Odds Ratio (OR)|1.63||||0|TWO_SIDED|95.0|1.47|1.82|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (18.5 - 25 kg per m\^2 Normal)||1.82|1.47|0.000
70882495|NCT03441633|141248146|SUPERIORITY||Odds Ratio (OR)|1.7||||0.202|TWO_SIDED|95.0|0.98|3.25|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (\<18.5 kg per m\^2 Underweight)||3.25|0.98|0.202
70882496|NCT03441633|141248146|SUPERIORITY||Odds Ratio (OR)|1.29||||0|TWO_SIDED|95.0|1.2|1.38|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (25 - 30 kg per m\^2 Overweight)||1.38|1.20|0.000
70882497|NCT03441633|141248146|SUPERIORITY||Odds Ratio (OR)|0.94||||0.003|TWO_SIDED|95.0|0.88|1.0|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (\>30 kg per m\^2 Obese)||1.00|0.88|0.003
70882498|NCT03441633|141248146|SUPERIORITY||Odds Ratio (OR)|0.86||||0.083|TWO_SIDED|95.0|0.56|1.28|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (18.5 - 25 kg per m\^2 Normal)||1.28|0.56|0.083
70882499|NCT03441633|141248146|SUPERIORITY||Odds Ratio (OR)|0.49||||0.011|TWO_SIDED|95.0|0.13|8.58|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (\<18.5 kg per m\^2 Underweight)||8.58|0.13|0.011
70882500|NCT03441633|141248146|SUPERIORITY||Odds Ratio (OR)|1.04||||0.227|TWO_SIDED|95.0|0.75|1.42|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (25 - 30 kg per m\^2 Overweight)||1.42|0.75|0.227
70882501|NCT03441633|141248146|SUPERIORITY||Odds Ratio (OR)|1.12||||0|TWO_SIDED|95.0|0.81|1.55|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (\>30 kg per m\^2 Obese)||1.55|0.81|0.000
70882502|NCT03441633|141248146|SUPERIORITY||Odds Ratio (OR)|1.5||||0|TWO_SIDED|95.0|1.28|1.76|||Chi-squared|||Warfarin vs. Apixaban in naive participants (18.5 - 25 kg per m\^2 Normal)||1.76|1.28|0.000
70882503|NCT03441633|141248146|SUPERIORITY||Odds Ratio (OR)|1.04||||0.202|TWO_SIDED|95.0|0.36|2.73|||Chi-squared|||Warfarin vs. Apixaban in naive participants (\<18.5 kg per m\^2 Underweight)||2.73|0.36|0.202
70882504|NCT03441633|141248146|SUPERIORITY||Odds Ratio (OR)|1.28||||0|TWO_SIDED|95.0|1.15|1.43|||Chi-squared|||Warfarin vs. Apixaban in naive participants (25 - 30 kg per m\^2 Overweight)||1.43|1.15|0.000
70882505|NCT03441633|141248146|SUPERIORITY||Odds Ratio (OR)|0.95||||0.003|TWO_SIDED|95.0|0.86|1.06|||Chi-squared|||Warfarin vs. Apixaban in naive participants (\>30 kg per m\^2 Obese)||1.06|0.86|0.003
70882506|NCT03441633|141248146|SUPERIORITY||Odds Ratio (OR)|1.27||||0.083|TWO_SIDED|95.0|0.95|1.68|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (18.5 - 25 kg per m\^2 Normal)||1.68|0.95|0.083
70963158|NCT03231943|141430900|OTHER||Power model|0.7968|||||TWO_SIDED|90.0|0.6424|0.9512|||||The statistical model (power model) is based on the PK parameters (AUC0-tau) from all active doses in Part 1|||0.9512|0.6424|
70882507|NCT03441633|141248146|SUPERIORITY||Odds Ratio (OR)|1.37||||0.011|TWO_SIDED|95.0|0.18|6.21|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (\<18.5 kg per m\^2 Underweight)||6.21|0.18|0.011
70882508|NCT03441633|141248146|SUPERIORITY||Odds Ratio (OR)|0.92||||0.227|TWO_SIDED|95.0|0.72|1.17|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (25 - 30 kg per m\^2 Overweight)||1.17|0.72|0.227
70882509|NCT03441633|141248146|SUPERIORITY||Odds Ratio (OR)|0.67||||0|TWO_SIDED|95.0|0.5|0.87|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (\>30 kg per m\^2 Obese)||0.87|0.50|0.000
70882510|NCT03441633|141248147|SUPERIORITY||Odds Ratio (OR)|0.68||||0|TWO_SIDED|95.0|0.61|0.75|||Chi-squared|||Dabigatran vs. Apixaban in naive participants||0.75|0.61|0.000
70882511|NCT03441633|141248147|SUPERIORITY||Odds Ratio (OR)|0.85||||0.052|TWO_SIDED|95.0|0.63|1.15|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants||1.15|0.63|0.052
70882512|NCT03441633|141248147|SUPERIORITY||Odds Ratio (OR)|0.73||||0|TWO_SIDED|95.0|0.67|0.8|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants||0.80|0.67|0.000
70882513|NCT03441633|141248147|SUPERIORITY||Odds Ratio (OR)|0.79||||0.052|TWO_SIDED|95.0|0.61|1.03|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants||1.03|0.61|0.052
70882514|NCT03441633|141248147|SUPERIORITY||Odds Ratio (OR)|1.26||||0|TWO_SIDED|95.0|1.17|1.36|||Chi-squared|||Acenocumarol vs. Apixaban in naive participants||1.36|1.17|0.000
70882515|NCT03441633|141248147|SUPERIORITY||Odds Ratio (OR)|0.74||||0.052|TWO_SIDED|95.0|0.45|1.27|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants||1.27|0.45|0.052
70882516|NCT03441633|141248147|SUPERIORITY||Odds Ratio (OR)|1.07||||0|TWO_SIDED|95.0|0.95|1.21|||Chi-squared|||Warfarin vs. Apixaban in naive participants||1.21|0.95|0.000
70882517|NCT03441633|141248147|SUPERIORITY||Odds Ratio (OR)|0.57||||0.052|TWO_SIDED|95.0|0.4|0.84|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants||0.84|0.40|0.052
70882518|NCT03441633|141248148|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0|TWO_SIDED|95.0|-0.26|-0.17|||ANOVA|||Dabigatran vs. Apixaban in naive participants (HAS - BLED)||-0.17|-0.26|0.000
70882519|NCT03441633|141248148|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.001|TWO_SIDED|95.0|-0.18|-0.01|||ANOVA|||Dabigatran vs. Apixaban in non-naive participants (HAS - BLED)||-0.01|-0.18|0.001
70882520|NCT03441633|141248148|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0|TWO_SIDED|95.0|-0.23|-0.15|||ANOVA|||Rivaroxaban vs. Apixaban in naive participants (HAS - BLED)||-0.15|-0.23|0.000
70882521|NCT03441633|141248148|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.001|TWO_SIDED|95.0|-0.19|-0.04|||ANOVA|||Rivaroxaban vs. Apixaban in non-naive participants (HAS - BLED)||-0.04|-0.19|0.001
70882522|NCT03441633|141248148|SUPERIORITY||Mean Difference (Final Values)|0.5||||0|TWO_SIDED|95.0|0.47|0.53|||ANOVA|||Acenocumarol vs. Apixaban in naive participants (HAS - BLED)||0.53|0.47|0.000
70882523|NCT03441633|141248148|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.001|TWO_SIDED|95.0|-0.32|-0.02|||ANOVA|||Acenocumarol vs. Apixaban in non-naive participants (HAS - BLED)||-0.02|-0.32|0.001
70882524|NCT03441633|141248148|SUPERIORITY||Mean Difference (Final Values)|0.17||||0|TWO_SIDED|95.0|0.12|0.23|||ANOVA|||Warfarin vs. Apixaban in naive participants (HAS - BLED)||0.23|0.12|0.000
70882525|NCT03441633|141248148|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.001|TWO_SIDED|95.0|-0.37|-0.1|||ANOVA|||Warfarin vs. Apixaban in non-naive participants (HAS - BLED)||-0.10|-0.37|0.001
70882526|NCT03441633|141248149|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0|TWO_SIDED|95.0|-0.24|-0.12|||ANOVA|||Dabigatran vs. Apixaban in naive participants (CHADS2)||-0.12|-0.24|0.000
70882527|NCT03441633|141248149|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0|TWO_SIDED|95.0|-0.35|-0.12|||ANOVA|||Dabigatran vs. Apixaban in non-naive participants (CHADS2)||-0.12|-0.35|0.000
70882528|NCT03441633|141248149|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0|TWO_SIDED|95.0|-0.28|-0.18|||ANOVA|||Rivaroxaban vs. Apixaban in naive participants (CHADS2)||-0.18|-0.28|0.000
70882529|NCT03441633|141248149|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0|TWO_SIDED|95.0|-0.31|-0.11|||ANOVA|||Rivaroxaban vs. Apixaban in non-naive participants (CHADS2)||-0.11|-0.31|0.000
70963159|NCT03231943|141430901|OTHER||Power model|0.789|||||TWO_SIDED|90.0|0.6149|0.9631|||||The statistical model (power model) is based on the PK parameters (Ctrough) from all active doses in Part 2|||0.9631|0.6149|
70882530|NCT03441633|141248149|SUPERIORITY||Mean Difference (Final Values)|0.21||||0|TWO_SIDED|95.0|0.17|0.25|||ANOVA|||Acenocumarol vs. Apixaban in naive participants (CHADS2)||0.25|0.17|0.000
70882531|NCT03441633|141248149|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0|TWO_SIDED|95.0|-0.7|-0.3|||ANOVA|||Acenocumarol vs. Apixaban in non-naive participants (CHADS2)||-0.30|-0.70|0.000
70882532|NCT03441633|141248149|SUPERIORITY||Mean Difference (Final Values)|0.08||||0|TWO_SIDED|95.0|0.01|0.14|||ANOVA|||Warfarin vs. Apixaban in naive participants (CHADS2)||0.14|0.01|0.000
70882533|NCT03441633|141248149|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0|TWO_SIDED|95.0|-0.54|-0.2|||ANOVA|||Warfarin vs. Apixaban in non-naive participants (CHADS2)||-0.20|-0.54|0.000
70882534|NCT03441633|141248150|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0|TWO_SIDED|95.0|-0.42|-0.26|||ANOVA|||Dabigatran vs. Apixaban in naive participants (CHA2DS2Vasc)||-0.26|-0.42|0.000
70882535|NCT03441633|141248150|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0|TWO_SIDED|95.0|-0.46|-0.19|||ANOVA|||Dabigatran vs. Apixaban in non-naive participants (CHA2DS2Vasc)||-0.19|-0.46|0.000
70882536|NCT03441633|141248150|SUPERIORITY||Mean Difference (Final Values)|-0.38||||0|TWO_SIDED|95.0|-0.45|-0.32|||ANOVA|||Rivaroxaban vs. Apixaban in naive participants (CHA2DS2Vasc)||-0.32|-0.45|0.000
70882537|NCT03441633|141248150|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0|TWO_SIDED|95.0|-0.39|-0.15|||ANOVA|||Rivaroxaban vs. Apixaban in non-naive participants (CHA2DS2Vasc)||-0.15|-0.39|0.000
70882538|NCT03441633|141248150|SUPERIORITY||Mean Difference (Final Values)|0.19||||0|TWO_SIDED|95.0|0.14|0.24|||ANOVA|||Acenocumarol vs. Apixaban in naive participants (CHA2DS2Vasc)||0.24|0.14|0.000
70882539|NCT03441633|141248150|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0|TWO_SIDED|95.0|-0.86|-0.37|||ANOVA|||Acenocumarol vs. Apixaban in non-naive participants (CHA2DS2Vasc)||-0.37|-0.86|0.000
70882540|NCT03441633|141248150|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0|TWO_SIDED|95.0|-0.18|-0.01|||ANOVA|||Warfarin vs. Apixaban in naive participants (CHA2DS2Vasc)||-0.01|-0.18|0.000
70882541|NCT03441633|141248150|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0|TWO_SIDED|95.0|-0.64|-0.21|||ANOVA|||Warfarin vs. Apixaban in non-naive participants (CHA2DS2Vasc)||-0.21|-0.64|0.000
70882542|NCT03441633|141248151|SUPERIORITY||Odds Ratio (OR)|1.88||||0.008|TWO_SIDED|95.0|0.77|5.3|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants||5.30|0.77|0.008
70882543|NCT03441633|141248151|SUPERIORITY||Odds Ratio (OR)|0.62||||0.008|TWO_SIDED|95.0|0.33|1.12|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants||1.12|0.33|0.008
70882544|NCT03441633|141248151|SUPERIORITY||Odds Ratio (OR)|0.55||||0.008|TWO_SIDED|95.0|0.2|1.99|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants||1.99|0.20|0.008
70882545|NCT03441633|141248151|SUPERIORITY||Odds Ratio (OR)|0.39||||0.008|TWO_SIDED|95.0|0.18|0.86|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants||0.86|0.18|0.008
70882546|NCT03441633|141248152|SUPERIORITY||Odds Ratio (OR)|1.41||||0|TWO_SIDED|95.0|1.14|1.75|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Poor adherence)||1.75|1.14|0.000
70882547|NCT03441633|141248152|SUPERIORITY||Odds Ratio (OR)|0.67||||0|TWO_SIDED|95.0|0.55|0.82|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Good adherence)||0.82|0.55|0.000
70882548|NCT03441633|141248152|SUPERIORITY||Odds Ratio (OR)|0.1||||0|TWO_SIDED|95.0|0.03|2.01|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Over adherence)||2.01|0.03|0.000
70882549|NCT03441633|141248152|SUPERIORITY||Odds Ratio (OR)|1.58||||0|TWO_SIDED|95.0|1.23|2.04|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Poor adherence)||2.04|1.23|0.000
70882550|NCT03441633|141248152|SUPERIORITY||Odds Ratio (OR)|0.44||||0|TWO_SIDED|95.0|0.34|0.57|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Good adherence)||0.57|0.34|0.000
70882551|NCT03441633|141248152|SUPERIORITY||Odds Ratio (OR)|0.43||||0|TWO_SIDED|95.0|0.02|3.73|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Over adherence)||3.73|0.02|0.000
70882552|NCT03441633|141248152|SUPERIORITY||Odds Ratio (OR)|0.66||||0|TWO_SIDED|95.0|0.52|0.84|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Poor adherence)||0.84|0.52|0.000
70882553|NCT03441633|141248152|SUPERIORITY||Odds Ratio (OR)|1.14||||0|TWO_SIDED|95.0|0.95|1.36|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Good adherence)||1.36|0.95|0.000
70882554|NCT03441633|141248152|SUPERIORITY||Odds Ratio (OR)|0.52||||0|TWO_SIDED|95.0|0.06|3.41|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Over adherence)||3.41|0.06|0.000
70882555|NCT03441633|141248152|SUPERIORITY||Odds Ratio (OR)|0.65||||0|TWO_SIDED|95.0|0.5|0.85|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Poor adherence)||0.85|0.50|0.000
70882556|NCT03441633|141248152|SUPERIORITY||Odds Ratio (OR)|1.11||||0|TWO_SIDED|95.0|0.9|1.37|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Good adherence)||1.37|0.90|0.000
70882557|NCT03441633|141248152|SUPERIORITY||Odds Ratio (OR)|1.07||||0|TWO_SIDED|95.0|0.22|5.85|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Over adherence)||5.85|0.22|0.000
70882558|NCT03441633|141248152|SUPERIORITY||Odds Ratio (OR)|3.37||||0|TWO_SIDED|95.0|2.86|3.99|||Chi-squared|||Acenocumarol vs. Apixaban in naive participants (Poor adherence)||3.99|2.86|0.000
70882559|NCT03441633|141248152|SUPERIORITY||Odds Ratio (OR)|0.11||||0|TWO_SIDED|95.0|0.09|0.13|||Chi-squared|||Acenocumarol vs. Apixaban in naive participants (Good adherence)||0.13|0.09|0.000
70882560|NCT03441633|141248152|SUPERIORITY||Odds Ratio (OR)|0.34||||0|TWO_SIDED|95.0|0.11|1.52|||Chi-squared|||Acenocumarol vs. Apixaban in naive participants (Over adherence)||1.52|0.11|0.000
70882561|NCT03441633|141248152|SUPERIORITY||Odds Ratio (OR)|1.23||||0|TWO_SIDED|95.0|0.78|1.91|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants (Poor adherence)||1.91|0.78|0.000
70882562|NCT03441633|141248152|SUPERIORITY||Odds Ratio (OR)|0.01||||0|TWO_SIDED|95.0|0.0|0.09|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants (Good adherence)||0.09|0.00|0.000
70882563|NCT03441633|141248152|SUPERIORITY||Odds Ratio (OR)|2.07||||0|TWO_SIDED|95.0|0.07|18.0|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants (Over adherence)||18.00|0.07|0.000
70882564|NCT03441633|141248152|SUPERIORITY||Odds Ratio (OR)|0.58||||0|TWO_SIDED|95.0|0.45|0.75|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Poor adherence)||0.75|0.45|0.000
70882565|NCT03441633|141248152|SUPERIORITY||Odds Ratio (OR)|0.51||||0|TWO_SIDED|95.0|0.41|0.63|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Good adherence)||0.63|0.41|0.000
70882566|NCT03441633|141248152|SUPERIORITY||Odds Ratio (OR)|29.4||||0|TWO_SIDED|95.0|11.01|123.8|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Over adherence)||123.80|11.01|0.000
70882567|NCT03441633|141248152|SUPERIORITY||Odds Ratio (OR)|1.31||||0|TWO_SIDED|95.0|0.91|1.86|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Poor adherence)||1.86|0.91|0.000
70882568|NCT03441633|141248152|SUPERIORITY||Odds Ratio (OR)|0.1||||0|TWO_SIDED|95.0|0.05|0.17|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Good adherence)||0.17|0.05|0.000
70882569|NCT03441633|141248152|SUPERIORITY||Odds Ratio (OR)|9.73||||0|TWO_SIDED|95.0|2.81|46.5|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Over adherence)||46.50|2.81|0.000
70882570|NCT03441633|141248153|SUPERIORITY||Odds Ratio (OR)|1.08||||0|TWO_SIDED|95.0|0.92|1.27|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Discontinuation first year)||1.27|0.92|0.000
70882571|NCT03441633|141248153|SUPERIORITY||Odds Ratio (OR)|1.45||||0|TWO_SIDED|95.0|1.15|1.83|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Discontinuation first year)||1.83|1.15|0.000
70882572|NCT03441633|141248153|SUPERIORITY||Odds Ratio (OR)|1.09||||0|TWO_SIDED|95.0|0.93|1.27|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Discontinuation first year)||1.27|0.93|0.000
70882573|NCT03441633|141248153|SUPERIORITY||Odds Ratio (OR)|1.18||||0|TWO_SIDED|95.0|0.96|1.47|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Discontinuation first year)||1.47|0.96|0.000
70882574|NCT03441633|141248153|SUPERIORITY||Odds Ratio (OR)|0.89||||0|TWO_SIDED|95.0|0.79|1.01|||Chi-squared|||Acenocumarol vs. Apixaban in naive participants (Discontinuation first year)||1.01|0.79|0.000
70882575|NCT03441633|141248153|SUPERIORITY||Odds Ratio (OR)|4.82||||0|TWO_SIDED|95.0|3.14|7.55|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants (Discontinuation first year)||7.55|3.14|0.000
70882576|NCT03441633|141248153|SUPERIORITY||Odds Ratio (OR)|1.41||||0|TWO_SIDED|95.0|1.19|1.67|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Discontinuation first year)||1.67|1.19|0.000
70882577|NCT03441633|141248153|SUPERIORITY||Odds Ratio (OR)|2.92||||0|TWO_SIDED|95.0|2.12|4.05|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Discontinuation first year)||4.05|2.12|0.000
70882578|NCT03441633|141248154|SUPERIORITY||Mean Difference (Final Values)|3.63||||0|TWO_SIDED|95.0|3.02|4.24|||ANOVA|||Dabigatran vs. Apixaban in naive participants (NDDDs)||4.24|3.02|0.000
70882579|NCT03441633|141248154|SUPERIORITY||Mean Difference (Final Values)|0.11||||0|TWO_SIDED|95.0|-0.77|0.98|||ANOVA|||Dabigatran vs. Apixaban in non-naive participants (NDDDs)||0.98|-0.77|0.000
70882580|NCT03441633|141248154|SUPERIORITY||Mean Difference (Final Values)|1.51||||0|TWO_SIDED|95.0|0.84|2.17|||ANOVA|||Rivaroxaban vs. Apixaban in naive participants (NDDDs)||2.17|0.84|0.000
70882581|NCT03441633|141248154|SUPERIORITY||Mean Difference (Final Values)|1.98||||0|TWO_SIDED|95.0|1.16|2.8|||ANOVA|||Rivaroxaban vs. Apixaban in non-naive participants (NDDDs)||2.80|1.16|0.000
70882582|NCT03441633|141248154|SUPERIORITY||Mean Difference (Final Values)|0.9||||0|TWO_SIDED|95.0|0.41|1.39|||ANOVA|||Acenocumarol vs. Apixaban in naive participants (NDDDs)||1.39|0.41|0.000
70882583|NCT03441633|141248154|SUPERIORITY||Mean Difference (Final Values)|-2.25||||0|TWO_SIDED|95.0|-4.32|-0.18|||ANOVA|||Acenocumarol vs. Apixaban in non-naive participants (NDDDs)||-0.18|-4.32|0.000
70882584|NCT03441633|141248154|SUPERIORITY||Mean Difference (Final Values)|28.52||||0|TWO_SIDED|95.0|27.56|29.48|||ANOVA|||Warfarin vs. Apixaban in naive participants (NDDDs)||29.48|27.56|0.000
70882585|NCT03441633|141248154|SUPERIORITY||Mean Difference (Final Values)|1.93||||0|TWO_SIDED|95.0|-1.05|4.9|||ANOVA|||Warfarin vs. Apixaban in non-naive participants (NDDDs)||4.90|-1.05|0.000
70882586|NCT01748643|141248178|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
70882587|NCT01748643|141248179|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
70882588|NCT01748643|141248180|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
70882589|NCT01748643|141248181|SUPERIORITY|||||||0.97|||||||t-test, 1 sided|||||||0.97
70882590|NCT01748643|141248182|SUPERIORITY|||||||0.64|||||||t-test, 1 sided|||||||0.64
70882591|NCT01748643|141248183|SUPERIORITY|||||||0.58|||||||t-test, 1 sided|||||||0.58
70882592|NCT03054870|141248219|NON_INFERIORITY|The non-inferiority margin was determined from a separate study where 6 blinded readers read and re-read 75 Xe-133 planar ventilation imaging studies in 2 read sessions separated by a minimum of 4 weeks. The readers scored the 6 regions of the lung using the same ventilation scoring metric used in this study. Based on analysis of the read/re-read results, 60% was established as a suitable margin for establishing the non-inferiority of Technegas compared to Xe-133.|||||<|0.0141||||||P-value is one-sided; for testing non-inferiority the associated critical value for PA is provided by lower bound of the 97.18% confidence interval.|Mixed Models Analysis|Binary agreement scores between Technegas and Xe-133 ventilation scores by subject-lung region served as the dependent variable in the model.||PA between Technegas and Xe-133 from analysis of each of the 3 blinded readers' ventilation scores was subjected to the following test of null (H0) versus alternate hypotheses (HA): H0: PA \<= 60% versus HA: PA \> 60%. The original sample size of 240 subjects was based on 90% power and one-sided alpha=0.025. For the unplanned interim analysis of 200 subjects, testing for non-inferiority used one-sided alpha=0.0141 (critical value provided by lower bound of the 97.18% confidence interval).|Binary agreement scores were analyzed for each reader separately using a generalized linear model with SAS® PROC GENMOD. The logit function (log odds ratio) was specified as the link function, and subject was specified as a repeated measure to allow for correlations between lung regions within a subject. The estimate of the intercept of the model using generalized estimating equation (GEE) methodology provided an overall estimate of the agreement and corresponding confidence interval in terms of the log odds ratio. Simple algebra was used to obtain the corresponding estimates and confidence intervals in terms of percent agreement (PA). For the study to be considered a success, the null hypothesis had to be rejected for at least 2 of the 3 blinded readers for the primary efficacy endpoint.|||<0.0141
70882593|NCT03054870|141248220|NON_INFERIORITY|The non-inferiority margin was determined from a separate study where 6 blinded readers read and re-read 75 Xe-133 planar ventilation imaging studies in 2 read sessions separated by a minimum of 4 weeks. The readers scored the 6 regions of the lung using the same ventilation scoring metric used in this study. Based on analysis of the read/re-read results, 60% was established as a suitable margin for establishing the non-inferiority of Technegas compared to Xe-133.|||||<|0.0141||||||P-value is one-sided; for testing non-inferiority the associated critical value for PA is provided by lower bound of the 97.18% confidence interval.|Mixed Models Analysis|Binary agreement scores between Technegas and Xe-133 ventilation scores by subject-lung region served as the dependent variable in the model.||PA between Technegas and Xe-133 from analysis of each of the 3 blinded readers' ventilation scores was subjected to the following test of null (H0) versus alternate hypotheses (HA): H0: PA \<= 60% versus HA: PA \> 60%. The original sample size of 240 subjects was based on 90% power and one-sided alpha=0.025. For the unplanned interim analysis of 200 subjects, testing for non-inferiority used one-sided alpha=0.0141 (critical value provided by lower bound of the 97.18% confidence interval).|Binary agreement scores were analyzed for each reader separately using a generalized linear model with SAS® PROC GENMOD. The logit function (log odds ratio) was specified as the link function, and subject was specified as a repeated measure to allow for correlations between lung regions within a subject. The estimate of the intercept of the model using generalized estimating equation (GEE) methodology provided an overall estimate of the agreement and corresponding confidence interval in terms of the log odds ratio. Simple algebra was used to obtain the corresponding estimates and confidence intervals in terms of percent agreement (PA). For the study to be considered a success, the null hypothesis had to be rejected for at least 2 of the 3 blinded readers for the primary efficacy endpoint.|||<0.0141
70882594|NCT03054870|141248221|OTHER||||||||||||||||||Estimates of inter-observer percent agreement were obtained as follows. For each reader-pair, binary agreement scores by subject and lung region were analyzed using a generalized linear model with SAS® PROC GENMOD. The logit function (log odds ratio) was specified as the link function, and subject was specified as a repeated measure to allow for correlations between lung regions within a subject. The estimate of the intercept of the model using generalized estimating equation (GEE) methodology provided an overall estimate of the agreement and corresponding confidence interval in terms of the log odds ratio. Simple algebra was used to obtain the corresponding estimates and confidence intervals in terms of percent agreement.|||
70882595|NCT03054870|141248222|OTHER||||||||||||||||||For each pair of readers, by lung region estimates of kappa statistics and their corresponding 95% confidence intervals were generated from cross-tabulation frequencies of the readers' ventilation scores using SAS® PROC FREQ and the AGREE option.|||
70882596|NCT02009046|141248223|SUPERIORITY||Odds Ratio (OR)|1.09||||0.643|TWO_SIDED|95.0|0.75|1.6|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.60|0.75|0.6430
70882597|NCT02009046|141248223|SUPERIORITY||Odds Ratio (OR)|0.75||||0.3718|TWO_SIDED|95.0|0.39|1.44|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.44|0.39|0.3718
70882598|NCT02009046|141248224|SUPERIORITY||Odds Ratio (OR)|0.96||||0.8083|TWO_SIDED|95.0|0.67|1.37|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.37|0.67|0.8083
70882599|NCT02009046|141248224|SUPERIORITY||Odds Ratio (OR)|0.6||||0.1083|TWO_SIDED|95.0|0.32|1.13|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.13|0.32|0.1083
70882600|NCT02009046|141248225|SUPERIORITY||Odds Ratio (OR)|0.62||||0.1006|TWO_SIDED|95.0|0.35|1.1|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.10|0.35|0.1006
70882601|NCT02009046|141248225|SUPERIORITY||Odds Ratio (OR)|0.49||||0.2117|TWO_SIDED|95.0|0.16|1.53|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.53|0.16|0.2117
70882602|NCT02009046|141248226|SUPERIORITY||Odds Ratio (OR)|1.37||||0.0218|TWO_SIDED|95.0|1.05|1.78|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.78|1.05|0.0218
70882603|NCT02009046|141248226|SUPERIORITY||Odds Ratio (OR)|1.73||||0.0211|TWO_SIDED|95.0|1.09|2.75|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||2.75|1.09|0.0211
70882604|NCT02009046|141248227|SUPERIORITY||Odds Ratio (OR)|1.25||||0.1763|TWO_SIDED|95.0|0.9|1.73|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.73|0.90|0.1763
70882605|NCT02009046|141248227|SUPERIORITY||Odds Ratio (OR)|0.85||||0.5869|TWO_SIDED|95.0|0.45|1.58|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.58|0.45|0.5869
70882606|NCT02009046|141248228|SUPERIORITY||Odds Ratio (OR)|1.04||||0.8102|TWO_SIDED|95.0|0.75|1.44|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.44|0.75|0.8102
70882607|NCT02009046|141248228|SUPERIORITY||Odds Ratio (OR)|0.72||||0.2956|TWO_SIDED|95.0|0.39|1.34|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.34|0.39|0.2956
70882608|NCT02009046|141248229|SUPERIORITY||Odds Ratio (OR)|1.13||||0.4645|TWO_SIDED|95.0|0.82|1.56|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.56|0.82|0.4645
70882609|NCT02009046|141248229|SUPERIORITY||Odds Ratio (OR)|0.77||||0.3809|TWO_SIDED|95.0|0.43|1.4|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.40|0.43|0.3809
70882610|NCT02009046|141248230|SUPERIORITY||Odds Ratio (OR)|0.75||||0.1335|TWO_SIDED|95.0|0.52|1.09|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.09|0.52|0.1335
70882611|NCT02009046|141248230|SUPERIORITY||Odds Ratio (OR)|0.56||||0.0741|TWO_SIDED|95.0|0.29|1.06|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.06|0.29|0.0741
70882612|NCT02009046|141248231|SUPERIORITY||Odds Ratio (OR)|1.04||||0.9085|TWO_SIDED|95.0|0.54|2.01|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||2.01|0.54|0.9085
70882613|NCT02009046|141248231|SUPERIORITY||Odds Ratio (OR)|1.15||||0.8059|TWO_SIDED|95.0|0.36|3.62|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||3.62|0.36|0.8059
70882614|NCT02009046|141248232|SUPERIORITY||Odds Ratio (OR)|0.87||||0.6861|TWO_SIDED|95.0|0.44|1.71|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.71|0.44|0.6861
70882615|NCT02009046|141248232|SUPERIORITY||Odds Ratio (OR)|0.0||||0.9973|TWO_SIDED||||||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.|No results provided, as model would not converge.|||||0.9973
70882616|NCT02009046|141248233|SUPERIORITY||Odds Ratio (OR)|1.97||||0.0002|TWO_SIDED|95.0|1.39|2.8|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||2.80|1.39|0.0002
70882617|NCT02009046|141248233|SUPERIORITY||Odds Ratio (OR)|2.71||||0.003|TWO_SIDED|95.0|1.44|5.09|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||5.09|1.44|0.0030
70882618|NCT00973479|141248246|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70882619|NCT00973479|141248247|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70882620|NCT00973479|141248248|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA of van der Waerden scores|||||||<0.001
70882621|NCT00973479|141248249|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70882622|NCT00973479|141248250|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA of van der Waerden scores|||||||<0.001
70882623|NCT03089606|141248251|OTHER|2-tailed Fisher's exact test||||||0.08|||||||2-tailed Fisher's exact test|||Null hypothesis. No association between baseline C11-AMT PET SUVmax value and antitumor response to pembrolizumab.||||0.08
70882624|NCT02136576|141248267|SUPERIORITY|||||||0.72||||||"This p-value is for the Air Schiff comparison.~The threshold of significance was 0.05 and no multiple comparisons were necessary."|Kruskal-Wallis|||Assuming the control group may exhibit a modest improvement in dentinal hypersensitivity (\~5%) whereas the two test groups should demonstrate a more significant improvement (\~30%). Assuming a common standard deviation of 25%, we will have 58% power to detect a difference between the 3 groups using one way analysis of variance, with 10 subjects per group, and setting alpha to 0.05 (nQuery Advisor, Version 7.0). Up to 13 subjects per group will be recruited, to allow for a 20% dropout rate.||||0.72
70882625|NCT02136576|141248267|SUPERIORITY|||||||0.93||||||"This p-value is for the Air VAS comparison.~The threshold of significance was 0.05 and no multiple comparisons were necessary."|Kruskal-Wallis|||Assuming the control group may exhibit a modest improvement in dentinal hypersensitivity (\~5%) whereas the two test groups should demonstrate a more significant improvement (\~30%). Assuming a common standard deviation of 25%, we will have 58% power to detect a difference between the 3 groups using one way analysis of variance, with 10 subjects per group, and setting alpha to 0.05 (nQuery Advisor, Version 7.0). Up to 13 subjects per group will be recruited, to allow for a 20% dropout rate.||||.93
70882626|NCT02136576|141248267|SUPERIORITY|||||||0.77||||||"This p-value is for the WaterSchiff comparison.~The threshold of significance was 0.05 and no multiple comparisons were necessary."|Kruskal-Wallis|||Assuming the control group may exhibit a modest improvement in dentinal hypersensitivity (\~5%) whereas the two test groups should demonstrate a more significant improvement (\~30%). Assuming a common standard deviation of 25%, we will have 58% power to detect a difference between the 3 groups using one way analysis of variance, with 10 subjects per group, and setting alpha to 0.05 (nQuery Advisor, Version 7.0). Up to 13 subjects per group will be recruited, to allow for a 20% dropout rate.||||.77
70882627|NCT02136576|141248267|SUPERIORITY|||||||0.93||||||"This p-value is for the WaterVAS comparison.~The threshold of significance was 0.05 and no multiple comparisons were necessary."|Kruskal-Wallis|||Assuming the control group may exhibit a modest improvement in dentinal hypersensitivity (\~5%) whereas the two test groups should demonstrate a more significant improvement (\~30%). Assuming a common standard deviation of 25%, we will have 58% power to detect a difference between the 3 groups using one way analysis of variance, with 10 subjects per group, and setting alpha to 0.05 (nQuery Advisor, Version 7.0). Up to 13 subjects per group will be recruited, to allow for a 20% dropout rate.||||.93
70882628|NCT00537381|141248268|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.728||||0.014|TWO_SIDED|95.0|1.112|2.686|||Log Rank||Hazard ratio and 95% confidence interval was estimated from a Cox proportional hazards model with treatment as the only explanatory factor.|||2.686|1.112|0.014
70882629|NCT00537381|141248269|SUPERIORITY_OR_OTHER|||||||0.795|||||||Fisher Exact|||||||0.795
70882630|NCT00537381|141248270|SUPERIORITY_OR_OTHER|||||||0.018|||||||Fisher Exact|||||||0.018
70882631|NCT00537381|141248271|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.476||||0.163|TWO_SIDED|95.0|0.853|2.522|||Log Rank||Hazard ratio and 95% confidence interval was estimated from a Cox proportional hazards model with treatment as the only explanatory factor.|||2.522|0.853|0.163
70882632|NCT01527682|141248285|OTHER||Proportion|76.7|||||TWO_SIDED|95.0|64.1|89.4|||||||The statistical analysis was performed according to study design. Using a Fleming single stage design (A'Hern approach) setting the probability of erroneously concluding that the responders rate is greater than 35% at 5% (one-sided alpha=0.05) and the probability of correctly concluding that the responders rate is at least 50% at 80% (beta error = 0.20), the minimum number of responder eyes was set at 31 out of 68, since this result is associated with a lower limit of the 90% exact confidence interval of 35.2%.|89.4|64.1|
70963160|NCT03231943|141430902|OTHER||Power model|0.7955|||||TWO_SIDED|90.0|0.6562|0.9349|||||The statistical model (power model) is based on the PK parameters (Cmax) from all active doses in Part 2|||0.9349|0.6562|
70882633|NCT01698463|141248320|OTHER||||||<|0.05||||||\<0.05 (threshold for significance).|Wilcoxon (Mann-Whitney)|||||||<0.05
70882634|NCT04709575|141248321|SUPERIORITY||linear mixed-effect model|-0.995||||0.0497|TWO_SIDED|95.0|-1.9886|-0.0011|||LS Mean Difference|||||-0.0011|-1.9886|0.0497
70882635|NCT04254978|141248346|SUPERIORITY||||||<|0.0001|||||||Exact binomial distribution|||Comparison of the true response rate of bomedemstat to a fixed efficacy target of 5%: Null hypothesis (H0): p ≤ 0.05 versus alternate hypothesis (H1): p \> 0.05||||<.0001
70882636|NCT00666757|141248366|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Mixed Models Analysis|||Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). The analysis will contrast the remission rates at 12 week endpoint between treatment groups.||||0.26
70882637|NCT00666757|141248367|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis.Treatment comparisons will include the contrast between treatment groups at 12-week endpoint.||||0.07
70882638|NCT00666757|141248368|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Mixed Models Analysis|||Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). Repeated Measures Analysis. The analysis will contrast the remission remission rates at 12-week endpoint.||||0.03
70882639|NCT00666757|141248369|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Mixed Models Analysis|||Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). The analysis will contrast the response rates at 12-week endpoint.||||0.09
70882640|NCT00666757|141248370|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Mixed Models Analysis|||Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). The analysis will contrast the response rates at 12-week endpoint.||||0.001
70882641|NCT00666757|141248371|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.002
70882642|NCT00666757|141248372|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.001
70882643|NCT00666757|141248373|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.003
70882644|NCT00666757|141248374|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis.Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.01
70882645|NCT00666757|141248375|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.02
70882646|NCT00666757|141248376|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.20
70882647|NCT00666757|141248377|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Mixed Models Analysis|||Only those patients who had at least moderate pain at baseline (defined as baseline BPI Average 24-Hour Pain Score greater than or equal to 3). Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.03
70882648|NCT00666757|141248378|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.03
70882649|NCT00666757|141248379|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.002
70882650|NCT00666757|141248380|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.01
70882651|NCT00666757|141248381|SUPERIORITY_OR_OTHER|||||||0.07||95.0||||Between group P-value|ANCOVA|||||||0.07
70882652|NCT00666757|141248382|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||Between group P-value|ANCOVA|||||||0.34
70882653|NCT00666757|141248383|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.02
70882654|NCT00666757|141248384|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.01
70882655|NCT00666757|141248385|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.97
70882656|NCT00666757|141248386|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.32
70882657|NCT00666757|141248387|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||Between group P-value|ANCOVA|||Transformed absolute score||||0.12
70963161|NCT03231943|141430907|OTHER||Power model|0.737|||||TWO_SIDED|90.0|0.5649|0.9091|||||The statistical model (power model) is based on the PK parameters (Cmax) from all active doses in Part 2|||0.9091|0.5649|
70882658|NCT00666757|141248388|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||Between group P-value|ANCOVA|||Transformed Absolute Score||||0.16
70882659|NCT00666757|141248389|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.002
70882660|NCT00666757|141248390|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.53
70882661|NCT05664490|141248401|SUPERIORITY||Risk Ratio (RR)|0.88||||0.44|TWO_SIDED|95.0|0.64|1.22||The threshold for statistical significance is 0.05.|Poisson regression|We used Poisson regression with a log-link and robust standard errors to assess the effect of our intervention on PrEP adherence at Week 12|The Standard of Care Mental Health Services arm was the reference category for the risk ratio.|||1.22|0.64|0.44
70882662|NCT05664490|141248402|SUPERIORITY||Risk Ratio (RR)|1.0||||0.99|TWO_SIDED|95.0|0.71|1.42||The threshold for statistical significance was 0.05.|Poisson regression|We used Poisson regression with a log-link and robust standard errors to assess the effect of our intervention on reduced CMD symptoms at Week 12.|The reference category for the risk ratio presented is the Standard of Care Mental Health Services arm.|||1.42|0.71|0.99
70882663|NCT05664490|141248403|SUPERIORITY||Risk Ratio (RR)|1.4||||0.03|TWO_SIDED|95.0|1.03|1.89||The threshold for statistical significance was 0.05|Poisson regression|We used Poisson regression with a log-link to estimate to assess the effect of our intervention on PrEP adherence at Week 4.|The Standard of Care Mental Health Services arm was the reference category for the risk ratio.|||1.89|1.03|0.03
70882664|NCT05664490|141248404|SUPERIORITY||Risk Ratio (RR)|0.81||||0.37|TWO_SIDED|95.0|0.5|1.29||The threshold for statistical significance was 0.05|Poisson regression|We used Poisson regression with a log-link to assess the effect of the intervention on common mental disorders at Week 4.|The Standard of Care Mental Health Services arm was the reference category.|||1.29|0.50|0.37
70882665|NCT03167879|141248429|SUPERIORITY||Odds Ratio (OR)|10.63|||||TWO_SIDED|95.0|2.79|40.49||||||||40.49|2.79|
70882666|NCT03167879|141248430|SUPERIORITY||Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.25|2.09||||||||2.09|0.25|
70882667|NCT03167879|141248431|SUPERIORITY||Odds Ratio (OR)|2.23|||||TWO_SIDED|95.0|0.02|257.6||||||||257.6|0.02|
70882668|NCT01589445|141248440|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.06|STANDARD_DEVIATION|39.47|<|0.161||95.0|-88.0|118.0||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||TC||118|-88.0|<0.161
70882669|NCT01589445|141248440|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.66|STANDARD_DEVIATION|143.22|<|0.913|TWO_SIDED|95.0|-397.0|976.0||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||TG||976|-397.0|<0.913
70882670|NCT01589445|141248440|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47|STANDARD_DEVIATION|9.59|<|0.322|TWO_SIDED|95.0|-35.0|19.0||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||HDL||19.0|-35.0|<0.322
70882671|NCT01589445|141248440|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.62|STANDARD_DEVIATION|32.05|<|0.21|TWO_SIDED|95.0|-113.8|76.2||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||LDL||76.2|-113.8|<0.210
70882672|NCT01589445|141248441|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74|STANDARD_DEVIATION|2.41|<|0.05|TWO_SIDED|95.0|-7.9|8.0||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, Multiple Logistic Regression (MLR), OR, Pearson Correlation)|ANOVA||The group 001 was divided according to Pro12Pro and Pro12Ala groups.There was no Ala12Ala group.These two groups were compared also in accordance with all parameters (glycemic levels, insulin levels, lipid profiles, BMI).|Change from Baseline in FSG at 3rd month||8.0|-7.9|<0.05
70882673|NCT01589445|141248442|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64|STANDARD_DEVIATION|1.07|>|0.05|TWO_SIDED|95.0|-4.4|2.4||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||||2.4|-4.4|>0.05
70882674|NCT01589445|141248443|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02|STANDARD_DEVIATION|0.12|<|0.001|TWO_SIDED|95.0|-0.4|0.27||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||||0.27|-0.40|<0.001
70882675|NCT01589445|141248443|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.04|STANDARD_DEVIATION|4.25|<|0.004|TWO_SIDED|95.0|-14.12|15.52||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||HOMA IR||15.52|-14.12|<0.004
70882676|NCT01589445|141248444|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.79|STANDARD_DEVIATION|84.46|<|0.808|TWO_SIDED|95.0|-346.4|328.1||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||HOMA B||328.10|-346.40|<0.808
70882677|NCT01589445|141248444|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.53|STANDARD_DEVIATION|54.0|<|0.025|TWO_SIDED|95.0|-148.7|180.0||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||HOMA S||180|-148.70|<0.025
70882678|NCT01589445|141248445|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.09|STANDARD_DEVIATION|10.2|<|0.039|TWO_SIDED|95.0|-27.04|26.52||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||FSI||26.52|-27.04|<0.039
70882679|NCT01835743|141248446|SUPERIORITY_OR_OTHER||||||<|5e-05|TWO_SIDED||||||Fisher Exact|||||||<0.00005
70882680|NCT01835743|141248447|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|t-test for two independent samples to compare the change in VAS scores across the evaluation period between the two procedure administration groups||||||<0.0001
70882681|NCT00176592|141248474|SUPERIORITY|This includes p value for rank sum test treatment comparison. This includes p value for rank sum test treatment comparison of intention to treat study population.|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||Fisher Exact|||This includes p value for rank sum test treatment comparison. This includes p value for rank sum test treatment comparison of intention to treat study population.||||<0.05
70882682|NCT03519971|141248477|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.247|TWO_SIDED|95.0|0.647|1.123|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).||The hazard ratio (HR) and confidence intervals (CIs) were calculated using a stratified Cox proportional hazards model, adjusting for age \[\< 65 versus (vs.) \>= 65 years\] and stage (IIIA vs. IIIB/C), with treatment as the only covariate and ties handled by Efron approach.||1.123|0.647|0.247
70882683|NCT03519971|141248478|SUPERIORITY||Difference in percentages|0.2||||0.976|TWO_SIDED|99.5|-15.2|16.3|||Cochran-Mantel-Haenszel|The analysis was performed using a Cochran-Mantel-Haenszel (CMH) test, stratified by age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).|The CIs for difference in percentages were estimated using Miettinen and Nurminen's method.|||16.3|-15.2|0.976
70882684|NCT03519971|141248479|SUPERIORITY|The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C), with treatment as the only covariate and ties handled by Efron approach.|Hazard Ratio (HR)|1.03||||0.823|TWO_SIDED|95.0|0.778|1.386|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).||||1.386|0.778|0.823
70882685|NCT03519971|141248480|SUPERIORITY|For the comparison between treatments, the Kaplan-Meier estimator of survival at 24 months for each treatment was used to obtain the HR and the test is based on the method described in Klein 2007. To account for the stratification factors, the estimates and test statistics in each strata were combined by weighting inversely proportionately according to each within stratum variance.|Hazard Ratio (HR)|1.04||||0.847|TWO_SIDED|95.0|0.716|1.502|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).||||1.502|0.716|0.847
70882686|NCT03519971|141248481|SUPERIORITY|The analysis was performed using a CMH test, stratified by age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).|Difference in percentages|0.0|||||TWO_SIDED|95.0|-4.8|3.0|||||The CIs for difference in percentages was calculated using Miettinen and Nurminen's method.|||3.0|-4.8|
70882687|NCT03519971|141248484|SUPERIORITY|The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C), with treatment as the only covariate and ties handled by Efron approach.|Hazard Ratio (HR)|0.95||||0.79|TWO_SIDED|95.0|0.649|1.413|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).||||1.413|0.649|0.790
70882688|NCT03519971|141248485|SUPERIORITY|The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C), with treatment as the only covariate and ties handled by Efron approach.|Hazard Ratio (HR)|0.81||||0.132|TWO_SIDED|95.0|0.614|1.071|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).||||1.071|0.614|0.132
70882689|NCT02039674|141248616|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|26.3||||0.0016|TWO_SIDED|95.0|8.9|42.1|||Miettinen & Nurminen Method|||||42.1|8.9|0.0016
70963162|NCT03231943|141430908|OTHER||Power model|0.7397|||||TWO_SIDED|90.0|0.5576|0.9218|||||The statistical model (power model) is based on the PK parameters (AUC0-24) from all active doses in Part 2|||0.9218|0.5576|
70882690|NCT02039674|141248617|SUPERIORITY|||||||0.0858|||||||Exact binomial distribution for testing|HO: ORR ≤20% versus H1: ORR \>20%||||||0.0858
70882691|NCT02039674|141248619|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.54||||0.00252|TWO_SIDED|95.0|0.35|0.83|||Log Rank|One-sided p-value based on log-rank test||||0.83|0.35|0.00252
70963163|NCT05564299|141430909|OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test||||0.053
70882692|NCT02039674|141248620|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.06762|TWO_SIDED|95.0|0.45|1.12|||Log Rank|One-sided p-value based on log-rank test||||1.12|0.45|0.06762
70963164|NCT03808688|141430954|OTHER|Descriptive statistics included the number of subjects/eyes(n), mean, SD, median, minimum, and maximum for continuous variables, and frequency and percentages for categorical variables.||||||||||||||||Cohorts assessed versus baseline treatment|All efficacy data were summarized at each timepoint using appropriate descriptive statistics for the overall populations as well as separately for monotherapy and concomitant therapy groups.|||
70963165|NCT02021292|141430971|SUPERIORITY||ratio of geometric means|0.84||||0.041|TWO_SIDED|95.0|0.7|0.99|||ANCOVA|ANCOVA model on log-transformed % of baseline PVR at Week 16 adjusted by treatment as a factor and log transformed PVR at baseline as a covariate.||The null hypothesis (change of PVR at rest in Week 16 in percent of baseline PVR in subjects treated with placebo or macitentan is the same) is tested on the primary endpoint by means of an analysis of covariance (ANCOVA) model on the log(e) transformed % of baseline PVR at rest at Week 16.||0.99|0.70|0.0410
70963166|NCT02021292|141430972|SUPERIORITY||least squares (LS) mean difference|34.04||||0.0326|TWO_SIDED|95.0|2.9|65.2||To control multiplicity across all endpoints, secondary endpoints were analyzed in sequence using hierarchical approach based on order and significance as pre-specified in protocol eliminating further adjustment for multiple comparisons.|ANCOVA|||The null hypothesis is that the mean change from baseline in 6MWD at Week 24 is the same in the placebo and the macitentan group. Statistical model is ANCOVA including 6MWD at baseline as a covariate, with treatment as factor in the model.||65.2|2.9|0.0326
70963167|NCT02021292|141430973|SUPERIORITY||least squares (LS) mean difference|-0.39||||0.3492|TWO_SIDED|95.0|-1.21|0.43||To control multiplicity across all endpoints, secondary endpoints were analyzed in sequence using hierarchical approach based on order and significance as pre-specified in protocol eliminating further adjustment for multiple comparisons.|ANCOVA|||The null hypothesis is that the mean change from baseline is the same in the placebo and the macitentan group. Statistical model is Analysis of Covariance including Borg dyspnea index at baseline as a covariate, with Treatment as factor in the model.||0.43|-1.21|0.3492
70963168|NCT02021292|141430974|SUPERIORITY||Odds Ratio (OR)|0.212||||0.0962|TWO_SIDED|95.0|0.001|1.464||To control multiplicity across all endpoints, secondary endpoints were analyzed in sequence using hierarchical approach based on order and significance as pre-specified in protocol eliminating further adjustment for multiple comparisons.|ANCOVA|||The null hypothesis is the odds of worsening are the same in the placebo and the macitentan group. Logistic regression is used for Treatment Group vs. Placebo comparison to generate odds ratio, confidence levels, and p-values with treatment and WHO functional class at baseline as factors in the model.||1.464|0.001|0.0962
70963169|NCT02021292|141430975|SUPERIORITY||Model-adjusted geometric mean ratio|0.81||||0.0098|TWO_SIDED|95.0|0.7|0.95||This is the post-hoc analysis and p-value is an exploratory p-value.|ANCOVA|ANCOVA model on log-transformed % of baseline PVR at Week 16 adjusted by treatment as a factor and log transformed PVR at baseline as a covariate.||The same statistical model as for the predefined analysis (ANCOVA) was applied, including 13 subjects with corrected hemodynamic values.||0.95|0.70|0.0098
70963170|NCT02021292|141430976|SUPERIORITY||Model-adjusted geometric mean ratio|0.79||||0.0061|TWO_SIDED|95.0|0.68|0.93||This is the post-hoc analysis and p-value is an exploratory p-value.|ANCOVA|ANCOVA model on log-transformed % of baseline PVR at Week 16 adjusted by treatment as a factor and log transformed PVR at baseline as a covariate.||||0.93|0.68|0.0061
70963171|NCT02021292|141430977|SUPERIORITY||Geometric mean ratio|0.85||||0.0414|TWO_SIDED|95.0|0.73|0.99||This is the post-hoc analysis and p-value is an exploratory p-value.|ANCOVA|ANCOVA model on log-transformed % of baseline PVR at Week 16 adjusted by treatment as a factor and log transformed PVR at baseline as a covariate.||||0.99|0.73|0.0414
70882693|NCT01358357|141248622|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||<|0.078|TWO_SIDED|95.0|0.49|1.04||A hazard ratio of time to recurrence and its corresponding 95% Wald CI were estimated for the lurasidone arm vs.placebo arm, using a Cox proportional hazards model.Cox model included treatment effect as fixed effect, and stratified by pooled country.|Cox Proportional Hazards Model|||It was assumed that the recurrence event rates during the double-blind phase were to be 24% and 39% for subjects treated with lurasidone and placebo, respectively. A total of 120 recurrence events were required to achieve 90% power to detect the 15% difference in subjects who had a recurrence event during the double-blind phase between the treatment groups using a log-rank test with two sided alpha level of 0.05.||1.04|0.49|<0.078
70963172|NCT02021292|141430978|SUPERIORITY||least squares (LS) mean difference|37.19||||0.0468|TWO_SIDED|95.0|0.54|73.83||This is the post-hoc analysis and p-value is an exploratory p-value.|ANCOVA|Statistical model is ANCOVA including 6MWD at baseline as a covariate, with treatment as factor in the model.||||73.83|0.54|0.0468
70963173|NCT02022085|141430987|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||PTA4 6 months with Baha Attract vs Unaided||||<0.0001
70963174|NCT02022085|141430987|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||PTA4 12 months with Baha Attract vs Unaided||||<0.0001
70963175|NCT02022085|141430987|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||PTA4 24 months with Baha Attract vs Unaided||||<0.0001
70963176|NCT02022085|141430988|SUPERIORITY_OR_OTHER||||||<|0.0001||||||All comparisons to the Unaided situation were p=\<0.0001.|Fisher's non-parametric permutation test|||Baha Attract after 24 months vs Unaided situation Pre-Op||||<0.0001
70882694|NCT01358357|141248623|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.72|||<|0.034|TWO_SIDED|95.0|0.54|0.98||A HR of time to discontinuation and corresponding 95% Wald CI were est. for lurasidone arm vs.the placebo arm, using a Cox proportional hazards model. Model included treatment effect including treatment as a fixed effect,stratified by pooled country.|Cox Proportional Hazards Model|||||0.98|0.54|<0.034
70882695|NCT01358357|141248624|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.72||||0.113|TWO_SIDED|95.0|0.48|1.08||A HR of time to recurrence and its corresponding 95% Wald CI were estimated for lurasidone arm vs. placebo arm,using a Cox proportional hazards model. Model included treatment effect including treatment as a fixed effect stratified by pooled country.|Cox Proportional hazard Model|||||1.08|0.48|0.113
70963177|NCT02022085|141430989|SUPERIORITY_OR_OTHER||||||<|0.0001||||||All comparisons to the Unaided situation were p=\<0.0001.|Fisher's non-parametric permutation test|||Baha Attract after 12 months vs Unaided situation Pre-Op||||<0.0001
70882696|NCT01358357|141248626|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|-0.09||||0.406|TWO_SIDED|95.0|-0.29|0.12||analysis of ANCOVA model contains treatment ,pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.12|-0.29|0.406
70882697|NCT01358357|141248627|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|-0.11||||0.162|TWO_SIDED|95.0|-0.26|0.04||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.04|-0.26|0.162
70882698|NCT01358357|141248628|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|-0.07||||0.496|TWO_SIDED|95.0|-0.27|0.13||Analysis of covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.13|-0.27|0.496
70882699|NCT01358357|141248629|SUPERIORITY_OR_OTHER||LS mean difference|-0.8||||0.128|TWO_SIDED|95.0|-1.8|0.2||Analysis of Covariance (ANCOVA) model contains treatment, and pool country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.2|-1.8|0.128
70882700|NCT01358357|141248630|SUPERIORITY_OR_OTHER||LS mean difference lurasdione vs.Placebo|-0.5||||0.485|TWO_SIDED|95.0|-1.9|0.9||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.9|-1.9|0.485
70882701|NCT01358357|141248631|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.582|TWO_SIDED|95.0|-0.8|0.5||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.5|-0.8|0.582
70882702|NCT01358357|141248632|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|-0.01||||0.42|TWO_SIDED|95.0|-0.5|0.2||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.2|-0.5|0.420
70882703|NCT01358357|141248633|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|-0.2||||0.788|TWO_SIDED|95.0|-1.6|1.2||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||1.2|-1.6|0.788
70882704|NCT01358357|141248634|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|-0.1||||0.38|TWO_SIDED|95.0|-0.3|0.1||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.1|-0.3|0.380
70882705|NCT01358357|141248635|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|0.37||||0.772|TWO_SIDED|95.0|-2.14|2.88||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||2.88|-2.14|0.772
70882706|NCT02590939|141248636|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
70882707|NCT02590939|141248637|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
70882708|NCT02590939|141248638|SUPERIORITY|||||||0.666||||||Statistical significance threshold set to 0.05|Fisher Exact|||||||0.666
70882709|NCT02590939|141248639|SUPERIORITY|||||||0.026||||||Statistical significance threshold set to 0.05|Wilcoxon (Mann-Whitney)|||||||0.026
70882710|NCT02590939|141248640|SUPERIORITY|||||||1||||||Statistical significance threshold set to 0.05|Wilcoxon (Mann-Whitney)|||||||1
70882711|NCT02590939|141248641|SUPERIORITY|||||||0.037||||||Statistical significance threshold set to 0.05|Wilcoxon (Mann-Whitney)|||||||0.037
70882712|NCT02590939|141248642|SUPERIORITY|||||||0.028||||||Statistical significance threshold set to 0.05|Wilcoxon (Mann-Whitney)|||||||0.028
70882713|NCT02590939|141248643|SUPERIORITY|||||||0.062||||||Statistical significance threshold set to 0.05|Wilcoxon (Mann-Whitney)|||||||0.062
70882714|NCT03979638|141248663|SUPERIORITY||Estimated percent change|-10.8||||0.1424|TWO_SIDED|95.0|-23.5|4.0|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||4.0|-23.5|0.1424
70882715|NCT03979638|141248663|SUPERIORITY||Estimated percent change|-6.1||||0.4602|TWO_SIDED|95.0|-20.8|11.2|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||11.2|-20.8|0.4602
70882716|NCT03979638|141248663|SUPERIORITY||Estimated percent change|-7.8||||0.4181|TWO_SIDED|95.0|-24.4|12.5|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||12.5|-24.4|0.4181
70882717|NCT03979638|141248663|SUPERIORITY||Estimated percent change|-16.7||||0.0855|TWO_SIDED|95.0|-32.3|2.6|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||2.6|-32.3|0.0855
70882718|NCT03979638|141248664|SUPERIORITY||Estimated percent change|-20.3||||0.001|TWO_SIDED|95.0|-29.9|-9.5|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-9.5|-29.9|0.0010
70882719|NCT03979638|141248664|SUPERIORITY||Estimated percent change|-17.7||||0.0186|TWO_SIDED|95.0|-29.9|-3.3|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-3.3|-29.9|0.0186
70882720|NCT03979638|141248664|SUPERIORITY||Estimated percent change|-19.4||||0.032|TWO_SIDED|95.0|-33.9|-1.9|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-1.9|-33.9|0.0320
70882721|NCT03979638|141248664|SUPERIORITY||Estimated percent change|-27.0||||0.0026|TWO_SIDED|95.0|-40.3|-10.8|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-10.8|-40.3|0.0026
70882722|NCT03979638|141248665|SUPERIORITY||Estimated percent change|-28.1||||0.0005|TWO_SIDED|95.0|-39.5|-14.5|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-14.5|-39.5|0.0005
70882723|NCT03979638|141248665|SUPERIORITY||Estimated percent change|-28.4||||0.0003|TWO_SIDED|95.0|-39.7|-15.0|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-15.0|-39.7|0.0003
70882724|NCT03979638|141248665|SUPERIORITY||Estimated percent change|-29.5||||0.0014|TWO_SIDED|95.0|-42.7|-13.2|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-13.2|-42.7|0.0014
70882725|NCT03979638|141248665|SUPERIORITY||Estimated percent change|-32.4||||0.0006|TWO_SIDED|95.0|-45.3|-16.4|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-16.4|-45.3|0.0006
70882726|NCT01883427|141248682|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Not significant|Wilcoxon (Mann-Whitney)|||Too few included to reach power||||>0.05
70882727|NCT01331148|141248696|OTHER|||||||0.0507|||||||t-test, 2 sided|||Due to the longitudinal nature of the data and presence of missing values, repeated measures analyses were conducted using the MIXED procedure in SAS. Spearman's rank correlation coefficient was used to quantify the relationship between PedsQL scores with 25OHD concentrations and pain days. Two-way analysis of variance models compared PedsQL scores between treatment groups over time.||||0.0507
70882728|NCT04920123|141248712|SUPERIORITY|||||||0.997||||||The threshold for statistical significance was p=0.05|t-test, 1 sided|||Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||0.997
70882729|NCT04920123|141248713|SUPERIORITY|||||||0.5||||||The threshold for statistical significance was p=0.05|t-test, 1 sided|||Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||0.500
70882730|NCT04920123|141248714|SUPERIORITY|||||||0.821||||||The threshold for statistical significance was p=0.05|t-test, 1 sided|||Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||0.821
70882731|NCT04920123|141248715|SUPERIORITY|||||||0.995||||||The threshold for statistical significance was p=0.05|t-test, 1 sided|||Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||0.995
70882732|NCT04920123|141248716|NON_INFERIORITY|Higher scores indicate more severe depression.||||||0.076|||||||t-test, 1 sided|||Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||0.076
70882733|NCT04920123|141248717|SUPERIORITY|||||||0.432|||||||t-test, 1 sided|The threshold for statistical significance was p=0.05||Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||0.432
70882734|NCT04920123|141248718|SUPERIORITY|Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||||0.75|||||||t-test, 1 sided|||||||0.750
70882735|NCT00278954|141248721|SUPERIORITY_OR_OTHER||SABI per subject per year|0.0||||0.01||99.0|0.0|0.101|||Poisson regression with log link||Mean SABI rate = 0 per subject per year. 1-sided 99% upper confidence bound could not be calculated.|The estimated serious acute bacterial infection (SABI) rate was calculated by dividing no. of infections by no.of subject years. The exponential of the upper limit of the 98% 2-sided Confidence Interval (CI) gave the upper, 1-sided, 99% confidence bound, estimated using Poisson regression. The equivalent upper bound per subject year was obtained by dividing this figure by total subject years.||0.101|0|0.01
70882736|NCT02121483|141248729|SUPERIORITY_OR_OTHER||Slope|0.949|STANDARD_ERROR_OF_MEAN|0.1075|||TWO_SIDED|95.0|0.7276|1.1704|||||Dose proportionality was assessed based on a power model that describes the functional relationship between the dose and AUC0-inf. Based on the estimate for the slope parameter β, a 2-sided 95% confidence interval (CI) for the slope was computed.|||1.1704|0.7276|
70882737|NCT02121483|141248730|SUPERIORITY_OR_OTHER||Slope|0.9597|STANDARD_ERROR_OF_MEAN|0.1088|||TWO_SIDED|95.0|0.7356|1.1838|||||Dose proportionality was assessed based on a power model that describes the functional relationship between the dose and AUC0-tz. Based on the estimate for the slope parameter β, a 2-sided 95% CI for the slope was computed.|||1.1838|0.7356|
70882738|NCT02121483|141248731|SUPERIORITY_OR_OTHER||Slope|0.8554|STANDARD_ERROR_OF_MEAN|0.1481|||TWO_SIDED|95.0|0.5504|1.1603|||||Dose proportionality was assessed based on a power model that describes the functional relationship between the dose and Cmax. Based on the estimate for the slope parameter β, a 2-sided 95% CI for the slope was computed.|||1.1603|0.5504|
70882739|NCT01817725|141248737|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70882740|NCT01420289|141248741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.0|STANDARD_ERROR_OF_MEAN|15.0||0.086|TWO_SIDED|95.0|10.0|80.0|||t-test, 2 sided|||||80|10|0.086
70882741|NCT01420289|141248742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.0|STANDARD_ERROR_OF_MEAN|11.0|<|0.05|TWO_SIDED|95.0|10.0|100.0|||t-test, 2 sided|||||100|10|<0.05
70882742|NCT00481195|141248745|SUPERIORITY_OR_OTHER|||||||0.0439||95.0|||||ANOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an analysis of variance (ANOVA) with treatment ands concurrent treatment for bipolar disorders as factors. A significant treatment-by baseline interaction was observed in the total score that violates the assumption of parallelism on which an ANCOVA is based, so the data was analyzed using ANOVA without baseline as a covariate rather than ANCOVA.||||0.0439
70882743|NCT00481195|141248746|SUPERIORITY_OR_OTHER|||||||0.0795||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0795
70882744|NCT00481195|141248747|SUPERIORITY_OR_OTHER|||||||0.0272||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0272
70882745|NCT00481195|141248748|SUPERIORITY_OR_OTHER|||||||0.0802||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0802
70882746|NCT00481195|141248749|SUPERIORITY_OR_OTHER|||||||0.2407||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.2407
70882747|NCT00481195|141248750|SUPERIORITY_OR_OTHER|||||||0.0502||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0502
70882748|NCT00481195|141248751|SUPERIORITY_OR_OTHER|||||||0.0612||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0612
70882749|NCT00481195|141248752|SUPERIORITY_OR_OTHER|||||||0.198||95.0||||P-value is from a Cochran-Mantel-Haenzel chi-square test adjusted for concurrent treatment for bipolar disorder|Cochran-Mantel-Haenszel|||||||0.1980
70882750|NCT00481195|141248753|SUPERIORITY_OR_OTHER|||||||0.896||95.0||||P-value is from a Cochran-Mantel-Haenzel chi-square test adjusted for concurrent treatment for bipolar disorder|Cochran-Mantel-Haenszel|||||||0.8960
70882751|NCT00481195|141248754|SUPERIORITY_OR_OTHER|||||||0.2575||95.0||||P-value is from a Cochran-Mantel-Haenzel chi-square test adjusted for concurrent treatment for bipolar disorder|Cochran-Mantel-Haenszel|||||||0.2575
70882752|NCT00481195|141248755|SUPERIORITY_OR_OTHER|||||||0.3129||95.0||||P-value is from a Cochran-Mantel-Haenzel chi-square test adjusted for concurrent treatment for bipolar disorder|Cochran-Mantel-Haenszel|||||||0.3129
70882753|NCT00481195|141248756|SUPERIORITY_OR_OTHER|||||||0.1565||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.1565
70882754|NCT00481195|141248757|SUPERIORITY_OR_OTHER|||||||0.6737||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.6737
70882755|NCT00481195|141248758|SUPERIORITY_OR_OTHER|||||||0.2249||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.2249
70882756|NCT00481195|141248759|SUPERIORITY_OR_OTHER|||||||0.0862||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0862
70882757|NCT00481195|141248760|SUPERIORITY_OR_OTHER|||||||0.9281||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.9281
70882758|NCT00481195|141248761|SUPERIORITY_OR_OTHER|||||||0.4428||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.4428
70882759|NCT00481195|141248762|SUPERIORITY_OR_OTHER|||||||0.0965||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0965
70963178|NCT02022085|141430990|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||All comparisons to the Unaided situation were p=\<0.0001.|Fisher's non-parametric permutation test|||Baha Attract after 6 months vs Unaided situation Pre-Op||||<0.0001
70963179|NCT02022085|141430991|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in Noise, 6 months Baha Attract vs Unaided||||<0.0001
70963180|NCT02022085|141430991|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Speech in Noise, 12 months Baha Attract vs Unaided||||<0.0001
70882760|NCT00481195|141248763|SUPERIORITY_OR_OTHER|||||||0.5389||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.5389
70882761|NCT00481195|141248764|SUPERIORITY_OR_OTHER|||||||0.0793||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0793
70963181|NCT02022085|141430991|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Speech in Noise, 24 months Baha Attract vs Unaided||||<0.0001
70882762|NCT00481195|141248765|SUPERIORITY_OR_OTHER|||||||0.3814||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.3814
70882763|NCT00481195|141248766|SUPERIORITY_OR_OTHER|||||||0.8099||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.8099
70882764|NCT00481195|141248767|SUPERIORITY_OR_OTHER|||||||0.0968||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0968
70882765|NCT00481195|141248768|SUPERIORITY_OR_OTHER|||||||0.1605||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.1605
70882766|NCT00481195|141248769|SUPERIORITY_OR_OTHER|||||||0.1869||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.1869
70882767|NCT00481195|141248770|SUPERIORITY_OR_OTHER|||||||0.0817||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0817
70882768|NCT00481195|141248771|SUPERIORITY_OR_OTHER|||||||0.3712||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.3712
70882769|NCT00481195|141248772|SUPERIORITY_OR_OTHER|||||||0.5427||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.5427
70882770|NCT00481195|141248773|SUPERIORITY_OR_OTHER|||||||0.3463||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.3463
70882771|NCT00481195|141248774|SUPERIORITY_OR_OTHER|||||||0.273||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.2730
70882772|NCT00481195|141248775|SUPERIORITY_OR_OTHER|||||||0.7791||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.7791
70882773|NCT00481195|141248776|SUPERIORITY_OR_OTHER|||||||0.9007||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.9007
70882774|NCT00481195|141248777|SUPERIORITY_OR_OTHER|||||||0.6431||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.6431
70882775|NCT00481195|141248778|SUPERIORITY_OR_OTHER|||||||0.6631||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder.||||||0.6631
70882776|NCT00481195|141248779|SUPERIORITY_OR_OTHER|||||||0.9768||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder||||||0.9768
70882777|NCT00481195|141248780|SUPERIORITY_OR_OTHER|||||||0.9873||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment fro bipolar disorder||||||0.9873
70963182|NCT02022085|141430992|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months: Speech in quiet at 50dB||||<0.0001
70963183|NCT02022085|141430992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||6 months: Speech in quiet at 65dB||||<0.0001
70963184|NCT02022085|141430992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||6 months: Speech in quiet at 80dB||||<0.0001
70963185|NCT02022085|141430992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||12 months: Speech in quiet at 50dB||||<0.0001
70882778|NCT00481195|141248781|SUPERIORITY_OR_OTHER|||||||0.4567||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder||||||0.4567
70882779|NCT00481195|141248782|SUPERIORITY_OR_OTHER|||||||0.6475||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder||||||0.6475
70882780|NCT00481195|141248783|SUPERIORITY_OR_OTHER|||||||0.5066||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder||||||0.5066
70882781|NCT00481195|141248784|SUPERIORITY_OR_OTHER|||||||0.4438||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder||||||0.4438
70882782|NCT02932904|141248785|SUPERIORITY||Least square (LS) Mean Difference|2.74|STANDARD_ERROR_OF_MEAN|1.04||0.009|TWO_SIDED|95.0|0.69|4.78||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA with last observation carried forward (LOCF) model was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||4.78|0.69|0.009
70963186|NCT02022085|141430992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||12 months: Speech in quiet at 65dB||||<0.0001
70963187|NCT02022085|141430992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||12 months: Speech in quiet at 80dB||||<0.0001
70963188|NCT02022085|141430992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||24 months: Speech in quiet at 50dB||||<0.0001
70882783|NCT02932904|141248785|SUPERIORITY||LS Mean Difference|1.05|STANDARD_ERROR_OF_MEAN|1.017||0.303|TWO_SIDED|95.0|-0.95|3.05||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||3.05|-0.95|0.303
70882784|NCT02932904|141248786|SUPERIORITY||LS Mean Difference|1.13|STANDARD_ERROR_OF_MEAN|0.627||0.072|TWO_SIDED|95.0|-0.1|2.37|||ANCOVA with LOCF|||Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||2.37|-0.10|0.072
70882785|NCT02932904|141248786|SUPERIORITY||LS Mean Difference|1.29|STANDARD_ERROR_OF_MEAN|0.612||0.035|TWO_SIDED|95.0|0.09|2.5|||ANCOVA with LOCF|||Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||2.50|0.09|0.035
70882786|NCT02932904|141248786|SUPERIORITY||LS Mean Difference|1.22|STANDARD_ERROR_OF_MEAN|0.846||0.149|TWO_SIDED|95.0|-0.44|2.89|||ANCOVA with LOCF|||Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||2.89|-0.44|0.149
70882787|NCT02932904|141248786|SUPERIORITY||LS Mean Difference|0.85|STANDARD_ERROR_OF_MEAN|0.828||0.303|TWO_SIDED|95.0|-0.78|2.48|||ANCOVA with LOCF|||Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||2.48|-0.78|0.303
70882788|NCT02932904|141248786|SUPERIORITY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|0.906||0.028|TWO_SIDED|95.0|0.22|3.78|||ANCOVA with LOCF|||Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||3.78|0.22|0.028
70882789|NCT02932904|141248786|SUPERIORITY||LS Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.886||0.645|TWO_SIDED|95.0|-1.33|2.15|||ANCOVA with LOCF|||Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||2.15|-1.33|0.645
70882790|NCT02932904|141248786|SUPERIORITY||LS Mean Difference|1.91|STANDARD_ERROR_OF_MEAN|0.943||0.043|TWO_SIDED|95.0|0.06|3.77|||ANCOVA with LOCF|||Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||3.77|0.06|0.043
70882791|NCT02932904|141248786|SUPERIORITY||LS Mean Difference|0.68|STANDARD_ERROR_OF_MEAN|0.923||0.465|TWO_SIDED|95.0|-1.14|2.49|||ANCOVA with LOCF|||Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||2.49|-1.14|0.465
70882792|NCT02932904|141248787|SUPERIORITY||LS Mean Difference|-1.63|STANDARD_ERROR_OF_MEAN|0.616||0.009|TWO_SIDED|95.0|-2.84|-0.41|||ANCOVA with LOCF|||Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||-0.41|-2.84|0.009
70882793|NCT02932904|141248787|SUPERIORITY||LS Mean Difference|-1.29|STANDARD_ERROR_OF_MEAN|0.834||0.123|TWO_SIDED|95.0|-2.93|0.35|||ANCOVA with LOCF|||Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||0.35|-2.93|0.123
70882794|NCT02932904|141248787|SUPERIORITY||LS Mean Difference|-1.85|STANDARD_ERROR_OF_MEAN|0.892||0.039|TWO_SIDED|95.0|-3.61|-0.1|||ANCOVA with LOCF|||Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||-0.10|-3.61|0.039
70882795|NCT02932904|141248787|SUPERIORITY||LS Mean Difference|-2.49|STANDARD_ERROR_OF_MEAN|0.929||0.008|TWO_SIDED|95.0|-4.32|-0.66|||ANCOVA with LOCF|||Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||-0.66|-4.32|0.008
70882796|NCT02932904|141248787|SUPERIORITY||LS Mean Difference|-2.77|STANDARD_ERROR_OF_MEAN|1.024||0.007|TWO_SIDED|95.0|-4.78|-0.75|||ANCOVA with LOCF|||Week 5, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||-0.75|-4.78|0.007
70882797|NCT02932904|141248788|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.612||0.419|TWO_SIDED|95.0|-1.7|0.71|||ANCOVA with LOCF|||Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||0.71|-1.70|0.419
70882798|NCT02932904|141248788|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.6||0.581|TWO_SIDED|95.0|-1.51|0.85|||ANCOVA with LOCF|||Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||0.85|-1.51|0.581
70882799|NCT02932904|141248788|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.828||0.938|TWO_SIDED|95.0|-1.69|1.56|||ANCOVA with LOCF|||Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||1.56|-1.69|0.938
70882800|NCT02932904|141248788|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.814||0.592|TWO_SIDED|95.0|-2.04|1.17|||ANCOVA with LOCF|||Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||1.17|-2.04|0.592
70882801|NCT02932904|141248788|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.886||0.87|TWO_SIDED|95.0|-1.6|1.89|||ANCOVA with LOCF|||Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||1.89|-1.60|0.870
70882802|NCT02932904|141248788|SUPERIORITY||LS Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|0.871||0.098|TWO_SIDED|95.0|-3.16|0.27|||ANCOVA with LOCF|||Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||0.27|-3.16|0.098
70882803|NCT02932904|141248788|SUPERIORITY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.923||0.532|TWO_SIDED|95.0|-2.39|1.24|||ANCOVA with LOCF|||Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||1.24|-2.39|0.532
70882804|NCT02932904|141248788|SUPERIORITY||LS Mean Difference|-1.82|STANDARD_ERROR_OF_MEAN|0.907||0.046|TWO_SIDED|95.0|-3.6|-0.03|||ANCOVA with LOCF|||Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||-0.03|-3.60|0.046
70882805|NCT02932904|141248788|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|1.018||0.977|TWO_SIDED|95.0|-2.03|1.97|||ANCOVA with LOCF|||Week 5, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||1.97|-2.03|0.977
70882806|NCT02932904|141248788|SUPERIORITY||LS Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|1.0||0.087|TWO_SIDED|95.0|-3.68|0.25|||ANCOVA with LOCF|||Week 5, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||0.25|-3.68|0.087
70882807|NCT02932904|141248789|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.44||||0.515|TWO_SIDED|95.0|0.037|5.201|||Regression, Logistic|||Week 1||5.201|0.037|0.515
70882808|NCT02932904|141248789|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.59||||0.677|TWO_SIDED|95.0|0.049|7.051|||Regression, Logistic|||Week 1||7.051|0.049|0.677
70882809|NCT02932904|141248789|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|1.47||||0.72|TWO_SIDED|95.0|0.181|11.912|||Regression, Logistic|||Week 1||11.912|0.181|0.720
70882810|NCT02932904|141248789|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.65||||0.732|TWO_SIDED|95.0|0.053|7.861|||Regression, Logistic|||Week 1||7.861|0.053|0.732
70882811|NCT02932904|141248789|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.87||||0.913|TWO_SIDED|95.0|0.066|11.303|||Regression, Logistic|||Week 1||11.303|0.066|0.913
70882812|NCT02932904|141248789|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.37||||0.164|TWO_SIDED|95.0|0.09|1.507|||Regression, Logistic|||Week 2||1.507|0.090|0.164
70882813|NCT02932904|141248789|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.25||||0.098|TWO_SIDED|95.0|0.05|1.287|||Regression, Logistic|||Week 2||1.287|0.050|0.098
70882814|NCT02932904|141248789|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|1.2||||0.758|TWO_SIDED|95.0|0.383|3.731|||Regression, Logistic|||Week 2||3.731|0.383|0.758
70882815|NCT02932904|141248789|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.44||||0.256|TWO_SIDED|95.0|0.107|1.814|||Regression, Logistic|||Week 2||1.814|0.107|0.256
70882816|NCT02932904|141248789|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.3||||0.154|TWO_SIDED|95.0|0.059|1.561|||Regression, Logistic|||Week 2||1.561|0.059|0.154
70882817|NCT02932904|141248789|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.36||||0.16|TWO_SIDED|95.0|0.087|1.497|||Regression, Logistic|||Week 3||1.497|0.087|0.160
70882818|NCT02932904|141248789|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.82||||0.744|TWO_SIDED|95.0|0.252|2.679|||Regression, Logistic|||Week 3||2.679|0.252|0.744
70882819|NCT02932904|141248789|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|2.43||||0.194|TWO_SIDED|95.0|0.636|9.317|||Regression, Logistic|||Week 3||9.317|0.636|0.194
70882820|NCT02932904|141248789|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.88||||0.871|TWO_SIDED|95.0|0.181|4.261|||Regression, Logistic|||Week 3||4.261|0.181|0.871
70882821|NCT02932904|141248789|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|2.0||||0.329|TWO_SIDED|95.0|0.497|8.037|||Regression, Logistic|||Week 3||8.037|0.497|0.329
70882822|NCT02932904|141248789|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.42||||0.187|TWO_SIDED|95.0|0.119|1.514|||Regression, Logistic|||Week 4||1.514|0.119|0.187
70882823|NCT02932904|141248789|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.82||||0.729|TWO_SIDED|95.0|0.273|2.476|||Regression, Logistic|||Week 4||2.476|0.273|0.729
70882824|NCT02932904|141248789|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|2.71||||0.133|TWO_SIDED|95.0|0.739|9.917|||Regression, Logistic|||Week 4||9.917|0.739|0.133
70882825|NCT02932904|141248789|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|1.15||||0.852|TWO_SIDED|95.0|0.266|4.961|||Regression, Logistic|||Week 4||4.961|0.266|0.852
70882826|NCT02932904|141248789|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|2.23||||0.24|TWO_SIDED|95.0|0.585|8.472|||Regression, Logistic|||Week 4||8.472|0.585|0.240
70882827|NCT02932904|141248789|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using rate of subjects that shifted from normal at baseline to abnormal after baseline as response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.55||||0.317|TWO_SIDED|95.0|0.166|1.789|||Regression, Logistic|||Week 5||1.789|0.166|0.317
70882828|NCT02932904|141248789|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|1.15||||0.79|TWO_SIDED|95.0|0.41|3.233|||Regression, Logistic|||Week 5||3.233|0.410|0.790
70882829|NCT02932904|141248789|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using rate of subjects that shifted from normal at baseline to abnormal after baseline as response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|3.64||||0.073|TWO_SIDED|95.0|0.888|14.911|||Regression, Logistic|||Week 5||14.911|0.888|0.073
70882830|NCT02932904|141248789|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using rate of subjects that shifted from normal at baseline to abnormal after baseline as response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|1.98||||0.371|TWO_SIDED|95.0|0.442|8.902|||Regression, Logistic|||Week 5||8.902|0.442|0.371
70882831|NCT02932904|141248789|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using rate of subjects that shifted from normal at baseline to abnormal after baseline as response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|4.19||||0.046|TWO_SIDED|95.0|1.027|17.063|||Regression, Logistic|||Week 5||17.063|1.027|0.046
70882832|NCT02932904|141248792|SUPERIORITY||LS Mean Difference|3.38|STANDARD_ERROR_OF_MEAN|1.082||0.002|TWO_SIDED|95.0|1.25|5.51||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||5.51|1.25|0.002
70882833|NCT02932904|141248792|SUPERIORITY||LS Mean Difference|1.63|STANDARD_ERROR_OF_MEAN|1.068||0.129|TWO_SIDED|95.0|-0.47|3.73||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||3.73|-0.47|0.129
70882834|NCT02932904|141248793|SUPERIORITY||LS Mean Difference|4.31|STANDARD_ERROR_OF_MEAN|1.078|<|0.001|TWO_SIDED|95.0|2.19|6.43||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||6.43|2.19|<0.001
70882835|NCT02932904|141248793|SUPERIORITY||LS Mean Difference|3.06|STANDARD_ERROR_OF_MEAN|1.072||0.005|TWO_SIDED|95.0|0.95|5.17||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||5.17|0.95|0.005
70882836|NCT03792672|141248818|SUPERIORITY||Least square mean (LSM) difference|115.0|STANDARD_ERROR_OF_MEAN|144.0||0.4278|TWO_SIDED|90.0|-128.0|359.0||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||||359|-128|0.4278
70882837|NCT03792672|141248818|SUPERIORITY||LSM difference|338.0|STANDARD_ERROR_OF_MEAN|147.0||0.0269|TWO_SIDED|90.0|90.5|585.0||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||||585|90.5|0.0269
70963189|NCT02022085|141430992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||24 months: Speech in quiet at 65dB||||<0.0001
70963190|NCT02022085|141430992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||24 months: Speech in quiet at 80dB||||<0.0001
70882838|NCT03792672|141248819|SUPERIORITY||LSM difference|-0.388|STANDARD_ERROR_OF_MEAN|0.582||0.5089|TWO_SIDED|90.0|-1.37|0.595||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||||0.595|-1.37|0.5089
70882839|NCT03792672|141248819|SUPERIORITY||LSM difference|-0.209|STANDARD_ERROR_OF_MEAN|0.581||0.7208|TWO_SIDED|90.0|-1.19|0.773||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||||0.773|-1.19|0.7208
70882840|NCT03792672|141248820|SUPERIORITY||LSM difference|14.0|STANDARD_ERROR_OF_MEAN|17.1||0.4174|TWO_SIDED|90.0|-14.8|42.8||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 50 ms peak-to-peak amplitude||42.8|-14.8|0.4174
70882841|NCT03792672|141248820|SUPERIORITY||LSM difference|15.1|STANDARD_ERROR_OF_MEAN|17.1||0.3832|TWO_SIDED|90.0|-25.3|31.5||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 50 ms peak-to-peak amplitude||31.5|-25.3|0.3832
70882842|NCT03792672|141248820|SUPERIORITY||LSM difference|-0.326|STANDARD_ERROR_OF_MEAN|4.09||0.9368|TWO_SIDED|90.0|-7.23|6.58||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 100 ms peak-to-peak amplitude||6.58|-7.23|0.9368
70882843|NCT03792672|141248820|SUPERIORITY||LSM difference|3.71|STANDARD_ERROR_OF_MEAN|4.16||0.379|TWO_SIDED|90.0|-3.32|10.7||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 100 ms peak-to-peak amplitude||10.7|-3.32|0.3790
70882844|NCT03792672|141248820|SUPERIORITY||LSM difference|7.36|STANDARD_ERROR_OF_MEAN|6.41||0.258|TWO_SIDED|90.0|-3.44|18.2||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 200 ms peak-to-peak amplitude||18.2|-3.44|0.2580
70882845|NCT03792672|141248820|SUPERIORITY||LSM difference|9.36|STANDARD_ERROR_OF_MEAN|6.41||0.1524|TWO_SIDED|90.0|-1.45|20.2|||Mixed Models Analysis|||LICI 200 ms peak-to-peak amplitude||20.2|-1.45|0.1524
70882846|NCT03792672|141248820|SUPERIORITY||LSM difference|17.2|STANDARD_ERROR_OF_MEAN|7.21||0.022|TWO_SIDED|90.0|5.06|29.4||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 300 ms peak-to-peak amplitude||29.4|5.06|0.0220
70882847|NCT03792672|141248820|SUPERIORITY||LSM difference|9.58|STANDARD_ERROR_OF_MEAN|7.23||0.1927|TWO_SIDED|90.0|-2.59|21.8||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 300 ms peak-to-peak amplitude||21.8|-2.59|0.1927
70882848|NCT03792672|141248821|SUPERIORITY||LSM difference|-5.65|STANDARD_ERROR_OF_MEAN|9.59||0.559|TWO_SIDED|90.0|-21.8|10.5||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||SICI 2 ms peak-to-peak amplitude||10.5|-21.8|0.5590
70882849|NCT03792672|141248821|SUPERIORITY||LSM difference|-16.1|STANDARD_ERROR_OF_MEAN|9.72||0.1049|TWO_SIDED|90.0|-32.5|0.242|||Mixed Models Analysis|||SICI 2 ms peak-to-peak amplitude||0.242|-32.5|0.1049
70882850|NCT03792672|141248821|SUPERIORITY||LSM difference|-16.7|STANDARD_ERROR_OF_MEAN|13.5||0.2238|TWO_SIDED|90.0|-39.4|6.06||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||SICI 5 ms peak-to-peak amplitude||6.06|-39.4|0.2238
70882851|NCT03792672|141248821|SUPERIORITY||LSM difference|-18.3|STANDARD_ERROR_OF_MEAN|13.6||0.1847|TWO_SIDED|90.0|-41.3|4.56|||Mixed Models Analysis|||SICI 5 ms peak-to-peak amplitude||4.56|-41.3|0.1847
70882852|NCT01907828|141248830|OTHER|||||||0.22|||||||Log Rank|||Kaplan-Meier analysis performed to provide freedom from atrial fibrillation rates at one year for each randomization arm using date of ablation procedure to date of first event.||||0.22
70882853|NCT01907828|141248834|SUPERIORITY|||||||0.2766|||||||Paired Student's t-test|||||||0.2766
70882854|NCT01907828|141248835|SUPERIORITY|||||||0.7663|||||||Wilcoxon signed-rank test|||||||0.7663
70882855|NCT01907828|141248838|SUPERIORITY||Mean Difference (Final Values)|-5.86|STANDARD_DEVIATION|15.21||0.0849|TWO_SIDED|95.0|-12.61|0.88|||Paired Student's t-test|||Change in ASBP at 12 months||0.88|-12.61|0.0849
70882856|NCT01907828|141248838|SUPERIORITY||Mean Difference (Final Values)|-5.82|STANDARD_DEVIATION|7.45||0.0014|TWO_SIDED|95.0|-9.12|-2.52|||Paired Student's t-test|||Change in ADBP at 12 months||-2.52|-9.12|0.0014
70882857|NCT01907828|141248838|SUPERIORITY||Mean Difference (Final Values)|-3.07|STANDARD_DEVIATION|19.21||0.5599|TWO_SIDED|95.0|-14.16|8.02|||Paired Student's t-test|||Change in ASBP at 12 months.||8.02|-14.16|0.5599
70882858|NCT01907828|141248838|SUPERIORITY||Mean Difference (Final Values)|-8.43|STANDARD_DEVIATION|9.42||0.0052|TWO_SIDED|95.0|-13.87|-2.99|||Paired Student's t-test|||Change in ADBP at 12 months||-2.99|-13.87|0.0052
70882859|NCT01907828|141248839|SUPERIORITY||Mean Difference (Final Values)|-5.71|STANDARD_DEVIATION|14.84||0.1326|TWO_SIDED|95.0|-13.34|1.93|||Paired Student's t-test|||Change in ASBP at 24 months||1.93|-13.34|0.1326
70882860|NCT01907828|141248839|SUPERIORITY||Mean Difference (Final Values)|-6.94|STANDARD_DEVIATION|6.06||0.0002|TWO_SIDED|95.0|-10.06|-3.83|||Paired Student's t-test|||Change in ADBP at 24 months||-3.83|-10.06|0.0002
70882861|NCT01907828|141248839|SUPERIORITY||Mean Difference (Final Values)|-8.58|STANDARD_DEVIATION|12.41||0.0354|TWO_SIDED|95.0|-16.47|-0.7|||Paired Student's t-test|||Change in ASBP at 24 months||-0.70|-16.47|0.0354
70882862|NCT01907828|141248839|SUPERIORITY||Mean Difference (Final Values)|-10.33|STANDARD_DEVIATION|8.53||0.0015|TWO_SIDED|95.0|-15.75|-4.91|||Paired Student's t-test|||Change in ADBP at 24 months||-4.91|-15.75|0.0015
70963191|NCT02022085|141430993|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months with Baha Attract vs Softband: change in PTA4||||0.38
70882863|NCT01907828|141248840|SUPERIORITY||Mean Difference (Final Values)|2.6|STANDARD_DEVIATION|24.4||0.5399|TWO_SIDED|95.0|-6.0|11.3|||Paired Student's t-test|||Change in OSBP at 12 months.||11.3|-6.0|0.5399
70882864|NCT01907828|141248840|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|11.8||0.8489|TWO_SIDED|95.0|-4.6|3.8|||Paired Student's t-test|||Change in Office Diastolic Blood Pressure (ODBP) at 12 months||3.8|-4.6|0.8489
70882865|NCT01907828|141248840|SUPERIORITY|Change in Office Systolic Blood Pressure (OSBP) at 12 months.|Mean Difference (Final Values)|2.0|STANDARD_DEVIATION|30.0||0.7999|TWO_SIDED|95.0|-14.6|18.6|||Paired Student's t-test|||||18.6|-14.6|0.7999
70882866|NCT01907828|141248840|SUPERIORITY||Mean Difference (Final Values)|-5.4|STANDARD_DEVIATION|15.8||0.2076|TWO_SIDED|95.0|-14.2|3.4|||Paired Student's t-test|||Change in ODBP at 12 months||3.4|-14.2|0.2076
70882867|NCT01907828|141248841|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_DEVIATION|22.3||0.882|TWO_SIDED|95.0|-7.9|9.1|||Paired Student's t-test|||Change in OSBP at 24 months||9.1|-7.9|0.8820
70882868|NCT01907828|141248841|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_DEVIATION|11.0||0.8019|TWO_SIDED|95.0|-3.7|4.7|||Paired Student's t-test|||Change in ODBP at 24 months||4.7|-3.7|0.8019
70882869|NCT01907828|141248841|SUPERIORITY||Mean Difference (Final Values)|7.4|STANDARD_DEVIATION|22.9||0.2177|TWO_SIDED|95.0|-4.8|19.6|||Paired Student's t-test|||Change in OSBP at 24 months||19.6|-4.8|0.2177
70882870|NCT01907828|141248841|SUPERIORITY||Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|15.5||0.4502|TWO_SIDED|95.0|-11.2|5.2|||Paired Student's t-test|||Change in ODBP at 24 months||5.2|-11.2|0.4502
70882871|NCT00591942|141248842|NON_INFERIORITY|95% CI were used|KM Survival Curves|0.5637||||0.5637|TWO_SIDED||||||Chi-squared|df=1||||||0.5637
70882872|NCT04007523|141248843|OTHER|Fisher's Exact Test||||||0.653|||||||Fisher Exact|||||||0.653
70882873|NCT04007523|141248843|OTHER|Fisher's Exact Test||||||0.614|||||||Fisher Exact|||||||0.614
70882874|NCT04007523|141248843|OTHER|Fisher's Exact Test||||||0.999|||||||Fisher Exact|||||||0.999
70882875|NCT00108160|141248873|SUPERIORITY_OR_OTHER|||||||0.356||||||No adjustments were made for multiple comparisons.|Chi-squared|||Our null hypothesis was that no significant effect of mupirocin ointment (treatment) on S. aureus re-infection would be seen at 18 months compared with placebo ointment. Based on prior studies, we estimated that 198 participants would need to be enrolled assuming a 20% dropout rate; 84 participants per arm would be required to detect a 66% decrease in re-infection from 30% to 10% with a significance level alpha of 0.05 and a power of 0.9.||||0.356
70882876|NCT02486042|141248897|OTHER|T-test for equality in means. The p-value threshold for significance was p \< 0.05.||||||0.22|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of STAT-3 in T0 blood samples in the Standard of Care versus Omegaven group||||0.22
70882877|NCT02486042|141248897|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.15|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of PPAR-gamma in T0 blood samples in the Standard of Care versus Omegaven group||||0.15
70882878|NCT02486042|141248897|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.78|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of STC-1 in T0 blood samples in the Standard of Care versus Omegaven group||||0.78
70882879|NCT02486042|141248901|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.43|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of STAT-3 in T1 blood samples in the Standard of Care versus Omegaven group||||0.43
70882880|NCT02486042|141248901|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.44|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of PPAR-gamma in T1 blood samples in the Standard of Care versus Omegaven group||||0.44
70882881|NCT02486042|141248901|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.5|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of STC-1 in T1 blood samples in the Standard of Care versus Omegaven group||||0.50
70882882|NCT02486042|141248902|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.001|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of STAT-3 in T2 blood samples in the Standard of Care versus Omegaven group||||0.001
70882883|NCT02486042|141248902|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.001|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of PPAR-gamma in T2 blood samples in the Standard of Care versus Omegaven group||||0.001
70882884|NCT02486042|141248902|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.01|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of STC-1 in T2 blood samples in the Standard of Care versus Omegaven group||||0.01
70882885|NCT01466387|141248904|NON_INFERIORITY_OR_EQUIVALENCE|GMC TF+YF+MenACWY-CRM/GMC TF+YF.|Ratio of GMC|1.14|||||TWO_SIDED|95.0|0.81|1.6||The testing was done by assessing the confidence interval of the ratio.|ANCOVA|The ANCOVA model included vaccine group and center as factors, age as covariate and was adjusted for baseline.||The primary criterion for immunogenicity (postvaccination, day 29) was that the lower limit of the two-sided 95% confidence interval around the observed ratio of geometric mean concentrations between one dose of typhoid Vi polysaccharide and yellow fever vaccines given concomitantly with MenACWY-CRM197 to typhoid Vi polysaccharide and yellow fever vaccines given alone was greater than 0.5.||1.6|0.81|
70882886|NCT01466387|141248905|NON_INFERIORITY_OR_EQUIVALENCE|GMT TF+YF+MenACWY/GMT TF+YF.|Ratio of GMT.|0.96|||||TWO_SIDED|95.0|0.65|1.41||The testing was done by assessing the confidence interval of the ratio.|ANCOVA|The ANCOVA model included vaccine group and center as factors, age as covariate and was adjusted for baseline.||The primary criterion for immunogenicity (postvaccination, day 29) was that the lower limit of the two sided 95% CI around the observed ratio of geometric mean titers between one dose of typhoid Vi polysaccharide and yellow fever vaccines given concomitantly with MenACWY-CRM197 to typhoid Vi polysaccharide and yellow fever vaccines given alone was greater than 0.5.||1.41|0.65|
70963192|NCT02022085|141430993|SUPERIORITY_OR_OTHER|||||||0.84|||||||Fisher's non-parametric permutation test|||12 months with Baha Attract vs Softband: change in PTA4||||0.84
70882887|NCT01466387|141248906|NON_INFERIORITY_OR_EQUIVALENCE|GMT JE + Rab + MenACWY-CRM/GMT JE + Rab.|Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.7|1.16||The testing was done by assessing the confidence interval of the ratio.|ANCOVA|The ANCOVA model included vaccine group and centers as factors, age as covariate and was adjusted for baseline.||The primary criterion for immunogenicity (postvaccination, day 57) was that the lower limit of the two sided 95% CI around the observed ratio of geometric mean titers between the second dose of Japanese Encephalitis and third dose of rabies virus vaccines given concomitantly with MenACWY-CRM197 to Japanese Encephalitis and rabies virus vaccines given alone was greater than 0.5.||1.16|0.7|
70882888|NCT01466387|141248907|NON_INFERIORITY_OR_EQUIVALENCE|GMC JE + Rab + MenACWY-CRM/GMC JE + Rab.|Ratio of GMC|0.91|||||TWO_SIDED|95.0|0.71|1.17||The testing was done by assessing the confidence interval of the ratio.|ANCOVA|The ANCOVA model included vaccine group and center as factors, age as covariate and was adjusted for baseline.||The primary criterion for immunogenicity (postvaccination, day 57) was that the lower limit of the two sided 95% CI around the observed ratio of geometric mean concentrations between the second dose of Japanese encephalitis and third dose of rabies virus vaccines given concomitantly with MenACWY-CRM197 to Japanese encephalitis and rabies virus vaccines given alone was greater than 0.5.||1.17|0.71|
70882889|NCT00566150|141248918|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|TWO_SIDED|95.0||||Unadjusted. Statistical significance was p\<0.05.|Mixed Models Analysis|Fixed categorical effects: group (as a between-subjects factor), time (as a within-subjects factor), group x time interaction.||Comparison of changes in outcome between treatment groups at week 6.||||0.29
70882890|NCT00566150|141248919|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07|TWO_SIDED|95.0||||Unadjusted. Statistical significance was p\<0.05.|Mixed Models Analysis|Fixed categorical effects: group (as a between-subjects factor), time (as a within-subjects factor), group x time interaction.||Comparison of changes in outcome between treatment groups at week 6.||||0.07
70882891|NCT00566150|141248920|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038||95.0||||Statistical significance was p\<0.05|Fisher Exact|Fisher's exact test was used to test for significance between groups.||Week 6||||.038
70882892|NCT00566150|141248921|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79||95.0||||Unadjusted. Statistical significance was p\<0.05.|Mixed Models Analysis|Fixed categorical effects: group (as a between-subjects factor), time (as a within-subjects factor), group x time interaction.||Comparison of changes in outcome between treatment groups.||||0.79
70882893|NCT02968979|141248928|OTHER|||||||0.0032|||||||likelihood-ratio test|||Statistical analysis applies to all rows and columns.||||0.0032
70882894|NCT02968979|141248928|OTHER|||||||0.0008|||||||Chi-squared|||"Statistical Analysis 2 for Frequency of the Different Stages of Cachexia, excluding the refractory cachexia stage, in the General NSCLC Population According to Molecular Abnormalities Associated With NSCLC.~Statistical analysis applies to all rows and columns."||||0.0008
70882895|NCT02968979|141248938|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||Statistical analysis compares all cachexia stages.||||<0.0001
70882896|NCT02968979|141248938|OTHER||||||<|0.0001||||||Without refractory cachexia|Kruskal-Wallis|Without refractory cachexia||Statistical analysis compares all cachexia stages.||||<0.0001
70882897|NCT02968979|141248938|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||Statistical analysis compares all cachexia stages.||||<0.0001
70882898|NCT02968979|141248938|OTHER||||||<|0.0001||||||Without refractory cachexia|Kruskal-Wallis|Without refractory cachexia||Statistical analysis compares all cachexia stages.||||<0.0001
70882899|NCT02968979|141248938|OTHER|||||||0.1085|||||||Kruskal-Wallis|||Statistical analysis compares all cachexia stages.||||0.1085
70882900|NCT02968979|141248938|OTHER|||||||0.0482||||||Without refractory cachexia|Kruskal-Wallis|Without refractory cachexia||Statistical analysis compares all cachexia stages.||||0.0482
70882901|NCT02968979|141248938|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||Statistical analysis compares all cachexia stages.||||<0.0001
70882902|NCT02968979|141248938|OTHER||||||<|0.0001||||||Without refractory cachexia|Kruskal-Wallis|Without refractory cachexia||Statistical analysis compares all cachexia stages.||||<0.0001
70882903|NCT02968979|141248938|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||Statistical analysis compares all cachexia stages.||||<0.0001
70882904|NCT02968979|141248938|OTHER||||||<|0.0001||||||Without refractory cachexia|Kruskal-Wallis|Without refractory cachexia||Statistical analysis compares all cachexia stages.||||<0.0001
70882905|NCT00788827|141248954|OTHER||||||<|0.05|||||||Mixed Models Analysis|||Each participants Hba1c (%) lab result was analysed pre and post stem cell infusion to achieve 2 mean readings per participant.||||<0.05
70882906|NCT01586819|141248972|SUPERIORITY||Z score|-3.3902||||0.002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that subjects receiving Botox A as an added pre-treatment would have lower scores on the facial wrinkle severity scale post-treatment.||||.002
70882907|NCT01586819|141248973|SUPERIORITY||Z score|3.6115||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that subjects receiving Botox A as an added pre-treatment would have higher difference scores, pre- to post-treatment, on the facial wrinkle severity scale suggesting a more pronounced effect of the chemical peel in combination with the Botox A therapy.||||.001
70882908|NCT00896337|141248974|SUPERIORITY_OR_OTHER||9-month major adverse event rate|3.4|||<|0.0001|TWO_SIDED|95.0|0.9|8.5||A one-sided exact-test was used to test the hypothesis that the primary endpoint rate in the Epic-treated cohort is less than the predefined performance goal of 17.0%.|One-sided exact-test|||MAE rate was compared to a predefined performance goal of 17.0%, based on literature-derived expected rate of 8.0% for iliac stenting plus a 9.0% margin. Study had 87% statistical power to show the MAE rate (accounting for 9-month attrition of \<=15%) is less than the performance goal, assuming a 9-month MAE rate of 8.0%. If the exact one-sided 95% upper confidence bound of the observed rate is lower than the performance goal, the Epic stent would be considered to have acceptable performance.||8.5|0.9|<0.0001
70882909|NCT02586896|141249042|SUPERIORITY|||||||0.29|||||||ANOVA|||||||0.29
70882910|NCT02586896|141249044|SUPERIORITY|||||||0.91|||||||ANOVA|||||||0.91
70882911|NCT02586896|141249045|SUPERIORITY|||||||0.09|||||||ANOVA|||||||0.09
70882912|NCT02586896|141249046|SUPERIORITY|||||||0.54|||||||ANOVA|||||||0.54
70882913|NCT02678676|141249110|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.3444|TWO_SIDED|95.0|0.88|1.04||No adjustment to the p-value|Regression, Cox|||Test for statistical difference between pioglitazone and placebo with respect to time of first occurrence of the primary composite outcome event.||1.04|0.88|0.3444
70963193|NCT02022085|141430993|SUPERIORITY_OR_OTHER|||||||0.89|||||||Fisher's non-parametric permutation test|||24 months with Baha Attract vs Softband: change in PTA4||||0.89
70882914|NCT02678676|141249111|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.83|1.16||||||Test for statistical difference between pioglitazone and placebo with respect to time of first occurrence of the primary composite outcome event.||1.16|0.83|
70882915|NCT00851799|141249119|SUPERIORITY_OR_OTHER||Difference in annual rate of change|-4.7||||0.013|TWO_SIDED|97.5|-8.9|-0.4||Inference was assessed against a type I error of 2.5% to account for multiple comparisons.|Mixed Models Analysis||The difference in the rate of CIMT change (Cohort A: ATV/RTV + FTC/TDF - Cohort C: DRV/RTV + FTC/TDF) was estimated by mixed effects linear regression model that adjusted for screening HIV-1 RNA level and Framingham risk score stratification factors.|The primary hypothesis was that rate of change of CIMT would be faster over 144 weeks in participants initiating a RTV-boosted protease inhibitor-containing regimen (the pooled ATV/RTV and DRV/RTV groups) compared with a RAL-containing regimen. However, In the event of a significant difference between ATV/RTV and DRV/RTV groups, the study was designed to make all pairwise treatment group comparisons.||-0.4|-8.9|0.013
70882916|NCT00851799|141249119|SUPERIORITY_OR_OTHER||Difference in annual rate of change|-2.8||||0.15|TWO_SIDED|97.5|-7.0|1.5||Inference was assessed against a type I error of 2.5% to account for multiple comparisons.|Mixed Models Analysis||The difference in the rate of CIMT change (Cohort A: ATV/RTV + FTC/TDF - Cohort B: RAL + FTC/TDF) was estimated by mixed effects linear regression model that adjusted for screening HIV-1 RNA level and Framingham risk score stratification factors.|The primary hypothesis was that rate of change of CIMT would be faster over 144 weeks in participants initiating a RTV-boosted protease inhibitor-containing regimen (the pooled ATV/RTV and DRV/RTV groups) compared with a RAL-containing regimen. However, In the event of a significant difference between ATV/RTV and DRV/RTV groups, the study was designed to make all pairwise treatment group comparisons.||1.5|-7.0|0.15
70882917|NCT00851799|141249119|SUPERIORITY_OR_OTHER||Difference in annual rate of change|1.9||||0.31|TWO_SIDED|97.5|-2.4|6.2||Inference was assessed against a type I error of 2.5% to account for multiple comparisons.|Mixed Models Analysis||The difference in the rate of CIMT change (Cohort C: DRV/RTV + FTC/TDF - Cohort B: RAL + FTC/TDF) was estimated by mixed effects linear regression model that adjusted for screening HIV-1 RNA level and Framingham risk score stratification factors.|The primary hypothesis was that rate of change of CIMT would be faster over 144 weeks in participants initiating a RTV-boosted protease inhibitor-containing regimen (the pooled ATV/RTV and DRV/RTV groups) compared with a RAL-containing regimen. However, In the event of a significant difference between ATV/RTV and DRV/RTV groups, the study was designed to make all pairwise treatment group comparisons.||6.2|-2.4|0.31
70882918|NCT00851799|141249120|SUPERIORITY_OR_OTHER||Difference in Change|0.24||||0.53|TWO_SIDED|97.5|-0.63|1.11||Inference was assessed against a type I error of 2.5% to account for multiple comparisons.|Regression, Linear||The difference in change in relative FMD (Cohort A: ATV/RTV+FTC/TDF - Cohort C: DRV/RTV+FTC/TDF); estimated by linear regression that adjusted for study entry BA diameter and screening HIV-1 RNA level and Framingham risk score stratification factors.|The study was designed to compare change from study entry to week 24 in brachial artery (BA) flow mediated dilation (FMD) between a RTV-boosted protease inhibitor-containing regimen (the pooled ATV/RTV and DRV/RTV groups) and a RAL-containing regimen. However, in the event of a significant difference between ATV/RTV and DRV/RTV groups, the study was designed to make all pairwise treatment group comparisons.||1.11|-0.63|0.53
70882919|NCT00851799|141249120|SUPERIORITY_OR_OTHER||Difference in Change (%)|-0.21||||0.53|TWO_SIDED|97.5|-0.98|0.55||Inference was assessed against a type I error of 2.5% to account for multiple comparisons.|Regression, Linear||The difference in change in relative FMD (Cohort B - Cohort A and C); estimated by linear regression that adjusted for study entry BA diameter and screening HIV-1 RNA level and Framingham risk score stratification factors.|The study was designed to compare change from study entry to week 24 in brachial artery (BA) flow mediated dilation (FMD) between a RTV-boosted protease inhibitor-containing regimen (the pooled ATV/RTV and DRV/RTV groups) and a RAL-containing regimen. However, in the event of a significant difference between ATV/RTV and DRV/RTV groups, the study was designed to make all pairwise treatment group comparisons.||0.55|-0.98|0.53
70882920|NCT01538862|141249191|SUPERIORITY|||||||0.82|||||||Regression, Linear|||||||0.82
70882921|NCT01400516|141249194|SUPERIORITY||Median Difference (Final Values)|9.5||||0.28|TWO_SIDED|||||A p-value \< 0.05 is considered statistically significant.|Linear mixed model||control-teriparatide|||||0.28
70882922|NCT01412866|141249197|SUPERIORITY_OR_OTHER|||||||0.08|||||||Chi-squared|df=1||||||0.08
70882923|NCT01796197|141249231|SUPERIORITY||Pathelogic Complete Response Rate|40.0|||||TWO_SIDED||||||Two stage design, exact method||Decision Rule: If the percentage of participants experiencing pathologic complete response (pCR) is ≤ 15% then the preoperative regimen is considered minimally effective. If the proportion of pCR ≥ 40% then the regimen is worthy of further study.|Null Hypothesis: pCR rate is less than or equal to 15% Alternative Hypothesis: pCR rate is greater than or equal to 40% Hypothesized False Positive Rate (alpha) : 3.9% Hypothesized False Negative Rate (1-beta) : 9.9%||||
70882924|NCT05477875|141249309|EQUIVALENCE|Two-way ANOVA using group and intervention as fixed factors were analyzed, with outcome variable p-value reported below, threshold 0.05.||||||0.538|||||||Wilcoxon (Mann-Whitney)|||||||0.538
70882925|NCT05477875|141249310|EQUIVALENCE|Two-way ANOVA using group and intervention as fixed factors were analyzed, with outcome variable p-value reported below, threshold 0.05.||||||0.538|||||||ANOVA|||||||0.538
70882926|NCT05477875|141249311|EQUIVALENCE|Two-way ANOVA using group and intervention as fixed factors were analyzed, with outcome variable p-value reported below, threshold 0.05.||||||0.516|||||||ANOVA|||||||0.516
70882927|NCT05477875|141249312|EQUIVALENCE|"Alpha = 0.05, two-way ANOVA with Group x Time Points as fixed factors and PROWL-SS from (1-100) as the dependent variable."|||||<|0.851|||||||ANOVA|||||||<0.851
70963194|NCT02022085|141430994|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||250Hz: 6 months with Baha Attract vs Softband||||0.34
70963195|NCT02022085|141430994|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||500Hz: 6 months with Baha Attract vs Softband||||0.0004
70963196|NCT02022085|141430994|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||1000Hz: 6 months with Baha Attract vs Softband||||0.22
70963197|NCT02022085|141430994|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||2000Hz: 6 months with Baha Attract vs Softband||||0.64
70963198|NCT02022085|141430994|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||3000Hz: 6 months with Baha Attract vs Softband||||0.039
70882928|NCT05477875|141249313|EQUIVALENCE|"Alpha = 0.05, two-way ANOVA with Group x Time Points as fixed factors and QIRC from (1-100) as the dependent variable."|||||<|0.543|||||||ANOVA|||||||<0.543
70882929|NCT05477875|141249314|EQUIVALENCE|"Alpha = 0.05, two-way ANOVA with Group x Time Points as fixed factors and OSDI from (0-48) as the dependent variable."||||||0.725|||||||ANOVA|||||||0.725
70882930|NCT05477875|141249315|EQUIVALENCE|Two-way ANOVA using group and intervention as fixed factors were analyzed, with outcome variable p-value reported below, threshold 0.05.||||||0.516|||||||ANOVA|||||||0.516
70882931|NCT05620576|141249322|SUPERIORITY||Posterior Mean Difference|0.1|||||TWO_SIDED|95.0|-0.61|0.82|||||Posterior mean difference with 95% credible interval is reported.|||0.82|-0.61|
70882932|NCT05620576|141249323|SUPERIORITY||Posterior Mean Difference|0.26|||||TWO_SIDED|95.0|-0.47|0.99|||||Posterior mean difference with 95% credible interval is reported.|||0.99|-0.47|
70882933|NCT05620576|141249324|SUPERIORITY||Posterior Mean Difference|0.33|||||TWO_SIDED|95.0|-0.11|0.78|||||Posterior mean difference with 95% credible interval is reported.|||0.78|-0.11|
70882934|NCT05620576|141249325|SUPERIORITY||Posterior Mean Difference|0.2|||||TWO_SIDED|95.0|-0.56|0.96|||||Posterior mean difference with 95% credible interval is reported.|||0.96|-0.56|
70882935|NCT05620576|141249326|SUPERIORITY||Posterior Mean Difference|-0.77|||||TWO_SIDED|95.0|-9.41|7.75|||||Posterior mean difference with 95% credible interval is reported.|||7.75|-9.41|
70882936|NCT05620576|141249327|SUPERIORITY||Posterior Mean Difference|-0.13|||||TWO_SIDED|95.0|-0.51|0.24|||||Posterior mean difference with 95% credible interval is reported.|||0.24|-0.51|
70963199|NCT02022085|141430994|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||4000Hz: 6 months with Baha Attract vs Softband||||0.012
70963200|NCT02022085|141430994|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6000Hz: 6 months with Baha Attract vs Softband||||<0.0001
70882937|NCT05620576|141249328|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.11|0.08|||||Posterior mean difference with 95% credible interval is reported.|||0.08|-0.11|
70882938|NCT05620576|141249329|SUPERIORITY||Posterior Mean Difference|23.02|||||TWO_SIDED|95.0|-108.05|152.33|||||Posterior mean difference with 95% credible interval is reported.|||152.33|-108.05|
70882939|NCT05394025|141249336|SUPERIORITY||Interaction|0.02||||0.77|TWO_SIDED|95.0|-0.13|0.18|||likelihood ratio test||Beta for time by COVID-19 status|Null hypothesis no difference in trends of I/ADL scores between Veterans with COVID-19 and comparators. We used adjusted linear mixed model (LMM) to model ADL scores over time (i.e., survey cycles) and by COVID-19 status. The LMM included an interaction term for time and COVID-19 status. LMM models were fitted with random intercepts (i.e., patient ID) and slopes (i.e., survey cycle). LMMs included fixed effects for patient baseline age, sex, and care assessment needs score.||0.18|-0.13|0.77
70882940|NCT05394025|141249336|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.6|TWO_SIDED|95.0|-0.44|0.67|||likelihood ratio test||Beta coefficient for mean difference in mean longitudinal I/ADL score|Null hypothesis no difference in trends of I/ADL scores between Veterans with COVID-19 and comparators. We used adjusted linear mixed model (LMM) to model I/ADL scores over time (i.e., survey cycles) and by COVID-19 status. The LMM included an interaction term for time and COVID-19 status. LMM models were fitted with random intercepts (i.e., patient ID) and slopes (i.e., survey cycle). LMMs included fixed effects for patient baseline age, sex, and care assessment needs score.||0.67|-0.44|0.60
70882941|NCT01203072|141249342|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significance level for Cochran-Armitage test and comparison using Shirley-Williams method was set at one-sided, 0.025. For other tests, significance level and confidence coefficient were set at two-sided, 0.05 and 0.95, respectively, unless specified|Cochran-Armitage|||As the primary analysis, the dose-response relationship in the incidence of thromboembolic event was verified using the Cochran-Armitage test.||||<0.001
70882942|NCT04064294|141249376|SUPERIORITY|||||||0.63||||||the threshold for statistical significance was p = 0.05|ANOVA|degrees of freedom = 78||||||0.63
70882943|NCT04064294|141249377|SUPERIORITY|||||||0.09||||||the threshold for statistical significance was p = 0.05|ANOVA|degrees of freedom = 78||||||0.09
70882944|NCT04064294|141249378|SUPERIORITY|||||||0.011|||||||Chi-squared|threshold for significance is 0.05, degrees of freedom = 2||||||0.011
70882945|NCT04064294|141249379|SUPERIORITY|||||||0.033|||||||ANOVA|degrees of freedom = 75||||||0.033
70882946|NCT03450707|141249380|OTHER||Mean Difference (Final Values)|0.34||||0.72|TWO_SIDED|95.0|-1.82|2.5||"Mixed model controlling for repeated measures within patients used to get a mean difference in lactate between the thiamine and placebo groups at 24 hours.~Lactate imputed using a penalty (20pc increase) for patients who expired."|Mixed Models Analysis|P-value is for the comparison at 24 hours from the mixed model (i.e, not a global p-value)||||2.50|-1.82|0.72
70882947|NCT03450707|141249381|OTHER||Mean Difference (Final Values)|-0.38||||0.43|TWO_SIDED|95.0|-1.34|0.58|||Regression, Linear|||As AUC-VO2s turned out to be normally distributed, we used a linear regression model to compare mean AUC-VO2s between treatment groups controlling for average temperature.||0.58|-1.34|0.43
70882948|NCT03450707|141249382|OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank-sum test, testing the null hypothesis that there is no difference in the distribution of 72-hour lactates between thiamine and placebo groups.|No parameter estimated other than p-value = 0.88 from Wilcoxon rank-sum test.|||0.88
70882949|NCT03450707|141249383|OTHER||Mean Difference (Final Values)|0.4||||0.072|TWO_SIDED|95.0|0.01|0.8||Mixed model controlling for repeated measures within patients used to get a mean difference in PDH specific activity between the thiamine and placebo groups at 72 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model. P-value is obtained from a model that uses a log-transformed version of the variable.||||0.80|0.01|0.072
70963201|NCT02022085|141430995|SUPERIORITY_OR_OTHER|||||||0.11|||||||Fisher's non-parametric permutation test|||250Hz: 12 months with Baha Attract vs Softband||||0.11
70963202|NCT02022085|141430995|SUPERIORITY_OR_OTHER|||||||0.066|||||||Fisher's non-parametric permutation test|||500Hz: 12 months with Baha Attract vs Softband||||0.066
70963203|NCT02022085|141430995|SUPERIORITY_OR_OTHER|||||||0.71|||||||Fisher's non-parametric permutation test|||1000Hz: 12 months with Baha Attract vs Softband||||0.71
70963204|NCT02022085|141430995|SUPERIORITY_OR_OTHER|||||||0.78|||||||Fisher's non-parametric permutation test|||2000Hz: 12 months with Baha Attract vs Softband||||0.78
70963205|NCT02022085|141430995|SUPERIORITY_OR_OTHER|||||||0.015|||||||Fisher's non-parametric permutation test|||3000Hz: 12 months with Baha Attract vs Softband||||0.015
70963206|NCT02022085|141430995|SUPERIORITY_OR_OTHER|||||||0.035|||||||Fisher's non-parametric permutation test|||4000Hz: 12 months with Baha Attract vs Softband||||0.035
70963207|NCT02022085|141430995|SUPERIORITY_OR_OTHER|||||||0.0013|||||||Fisher's non-parametric permutation test|||6000Hz: 12 months with Baha Attract vs Softband||||0.0013
70882950|NCT03450707|141249384|OTHER||Mean Difference (Final Values)|2.4||||0.044|TWO_SIDED|95.0|0.1|4.7||Mixed model controlling for repeated measures within patients used to get a mean difference in PDH activity between the thiamine and placebo groups at 72 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model. P-value is obtained from a model that uses a log-transformed version of the variable.||||4.7|0.1|0.044
70963208|NCT02022085|141430996|SUPERIORITY_OR_OTHER|||||||0.0051|||||||Fisher's non-parametric permutation test|||250Hz: 24 months with Baha Attract vs Softband||||0.0051
70963209|NCT02022085|141430996|SUPERIORITY_OR_OTHER|||||||0.26|||||||Fisher's non-parametric permutation test|||500Hz: 24 months with Baha Attract vs Softband||||0.26
70963210|NCT02022085|141430996|SUPERIORITY_OR_OTHER|||||||0.22|||||||Fisher's non-parametric permutation test|||1000Hz: 24 months with Baha Attract vs Softband||||0.22
70963211|NCT02022085|141430996|SUPERIORITY_OR_OTHER|||||||0.57|||||||Fisher's non-parametric permutation test|||2000Hz: 24 months with Baha Attract vs Softband||||0.57
70963212|NCT02022085|141430996|SUPERIORITY_OR_OTHER|||||||0.064|||||||Fisher's non-parametric permutation test|||3000Hz: 24 months with Baha Attract vs Softband||||0.064
70963213|NCT02022085|141430996|SUPERIORITY_OR_OTHER|||||||0.064|||||||Fisher's non-parametric permutation test|||4000Hz: 24 months with Baha Attract vs Softband||||0.064
70963214|NCT02022085|141430996|SUPERIORITY_OR_OTHER|||||||0.0051|||||||Fisher's non-parametric permutation test|||6000Hz: 24 months with Baha Attract vs Softband||||0.0051
70963215|NCT02022085|141430997|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months: Speech in Noise with Baha Attract vs Softband||||0.46
70963216|NCT02022085|141430997|SUPERIORITY_OR_OTHER|||||||0.19|||||||Fisher's non-parametric permutation test|||12 months: Speech in Noise with Baha Attract vs Softband||||0.19
70963217|NCT02022085|141430997|SUPERIORITY_OR_OTHER|||||||0.31|||||||Fisher's non-parametric permutation test|||24 months: Speech in Noise with Baha Attract vs Softband||||0.31
70963218|NCT02022085|141430998|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months Speech in Quiet at 50dB||||0.43
70963219|NCT02022085|141430998|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months Speech in Quiet at 65dB||||0.16
70963220|NCT02022085|141430998|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months Speech in Quiet at 80dB||||0.65
70963221|NCT02022085|141430998|SUPERIORITY_OR_OTHER|||||||0.93|||||||Fisher's non-parametric permutation test|||12 months Speech in Quiet at 50dB||||0.93
70963222|NCT02022085|141430998|SUPERIORITY_OR_OTHER|||||||0.094|||||||Fisher's non-parametric permutation test|||12 months Speech in Quiet at 65dB||||0.094
70963223|NCT02022085|141430998|SUPERIORITY_OR_OTHER|||||||0.44|||||||Fisher's non-parametric permutation test|||12 months Speech in Quiet at 80dB||||0.44
70963224|NCT02022085|141430998|SUPERIORITY_OR_OTHER|||||||0.021|||||||Fisher's non-parametric permutation test|||24 months Speech in Quiet at 50dB||||0.021
70963225|NCT02022085|141430998|SUPERIORITY_OR_OTHER|||||||0.024|||||||Fisher's non-parametric permutation test|||24 months Speech in Quiet at 65dB||||0.024
70963226|NCT02022085|141430998|SUPERIORITY_OR_OTHER|||||||0.59|||||||Fisher's non-parametric permutation test|||24 months Speech in Quiet at 80dB||||0.59
70963227|NCT02022085|141430999|SUPERIORITY_OR_OTHER|||||||0.088|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Comprehensive health state||||0.088
70963228|NCT02022085|141430999|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Vision||||0.88
70963229|NCT02022085|141430999|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Hearing||||0.020
70963230|NCT02022085|141430999|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Speech||||0.039
70963231|NCT02022085|141430999|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Ambulation||||0.25
70963232|NCT02022085|141430999|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Dexterity||||0.38
70963233|NCT02022085|141430999|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Emotion||||0.43
70963234|NCT02022085|141430999|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Cognition||||0.85
70963235|NCT02022085|141430999|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Pain||||0.25
70963236|NCT02022085|141430999|SUPERIORITY_OR_OTHER|||||||0.088|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||24 months change in Comprehensive health state||||0.088
70963237|NCT02022085|141430999|SUPERIORITY_OR_OTHER|||||||0.63|||||||Fisher's non-parametric permutation test|||24 months change in Vision||||0.63
70963238|NCT02022085|141430999|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||24 months change in Hearing||||0.045
70963239|NCT02022085|141430999|SUPERIORITY_OR_OTHER|||||||0.016|||||||Fisher's non-parametric permutation test|||24 months change in Speech||||0.016
70963240|NCT02022085|141430999|SUPERIORITY_OR_OTHER|||||||0.25|||||||Fisher's non-parametric permutation test|||24 months change in Ambulation||||0.25
70963241|NCT02022085|141430999|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxan Signed Rank Test|Fisher's non-parametric permutation test failed to approximate p value so Wilcoxan Signed Rank Test instead||24 months change in Dexterity||||0.50
70963242|NCT02022085|141430999|SUPERIORITY_OR_OTHER|||||||0.29|||||||Fisher's non-parametric permutation test|||24 months change in Emotion||||0.29
70963243|NCT02022085|141430999|SUPERIORITY_OR_OTHER|||||||0.92|||||||Fisher's non-parametric permutation test|||24 months change in Cognition||||0.92
70963244|NCT02022085|141430999|SUPERIORITY_OR_OTHER|||||||0.02|||||||Fisher's non-parametric permutation test|||24 months change in Pain||||0.020
70963245|NCT02022085|141431000|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months: Ease of communication||||<0.0001
70963246|NCT02022085|141431000|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months: Background noise||||<0.0001
70963247|NCT02022085|141431000|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||6 months: Reverberation||||<0.0001
70882951|NCT03450707|141249385|OTHER||Mean Difference (Final Values)|-48.5||||0.828|TWO_SIDED|95.0|-297.0|200.0||Mixed model controlling for repeated measures within patients used to get a mean difference in PDH quantity between the thiamine and placebo groups at 72 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model. P-value is obtained from a model that uses a log-transformed version of the variable.||||200.0|-297.0|0.828
70882952|NCT03450707|141249388|OTHER||Mean Difference (Final Values)|2.34||||0.1|TWO_SIDED|95.0|0.47|4.22||Mixed model controlling for repeated measures within patients used to get a mean difference in SOFA scores between the thiamine and placebo groups at 72 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model.||||4.22|0.47|0.10
70882953|NCT03450707|141249390|OTHER||Mean Difference (Final Values)|-1.0||||0.43|TWO_SIDED|95.0|-3.6|1.6||Mixed model controlling for repeated measures within patients used to get a mean difference in Basal Respiration between the thiamine and placebo groups at 24 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model. P-value is obtained from a model that uses a log-transformed version of the variable.|Mean difference uses a non-logged version of the variable.|||1.6|-3.6|0.43
70882954|NCT03450707|141249391|OTHER||Mean Difference (Final Values)|0.76||||0.02|TWO_SIDED|95.0|-0.27|1.78||Mixed model controlling for repeated measures within patients used to get a mean difference in creatinine between the thiamine and placebo groups at 72 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model. P-value is obtained from a model that uses a log-transformed version of the variable.||||1.78|-0.27|0.02
70882955|NCT03343483|141249393|SUPERIORITY||Mean Difference (Final Values)|-0.138|STANDARD_ERROR_OF_MEAN|1.06||0.896|TWO_SIDED|95.0|-2.21|1.93|||Mixed Models Analysis|||||1.93|-2.21|.896
70882956|NCT03343483|141249394|SUPERIORITY||Mean Difference (Final Values)|0.44||||0.8|TWO_SIDED||||||ANOVA|||||||0.80
70882957|NCT03343483|141249395|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.33|TWO_SIDED||||||Mixed Models Analysis|||||||0.33
70882958|NCT03343483|141249396|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.58|TWO_SIDED||||||Mixed Models Analysis|||||||0.58
70882959|NCT03343483|141249397|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.73|TWO_SIDED||||||Mixed Models Analysis|||||||0.73
70882960|NCT03343483|141249398|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.57|TWO_SIDED||||||Mixed Models Analysis|||||||0.57
70882961|NCT03387813|141249422|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1624|TWO_SIDED|95.0|0.74|1.05|||Anderson-Gill model (robust sandwich)|||||1.05|0.74|0.1624
70882962|NCT03387813|141249426|EQUIVALENCE|Clinical equivalence was met if the lower limit of the confidence interval (CI) of ln(HR) for the primary endpoint in Elevated NT-proBNP/BNP only vs. prior HFH only subjects is \> -0.2877 and the upper limit is \< 0.2877.|Hazard Ratio (HR)|0.51|||||TWO_SIDED|90.0|0.44|0.6||||||||0.60|0.44|
70882963|NCT03387813|141249430|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0958|TWO_SIDED|95.0|0.7|1.03|||Anderson-Gill model (robust sandwich)|||||1.03|0.70|0.0958
70882964|NCT03387813|141249434|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0644|TWO_SIDED|95.0|0.68|1.01|||Anderson-Gill model (robust sandwich)|||||1.01|0.68|0.0644
70882965|NCT03387813|141249438|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.8867|TWO_SIDED|95.0|0.61|1.77|||Anderson-Gill model (robust sandwich)|||||1.77|0.61|0.8867
70882966|NCT03387813|141249442|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.7119|TWO_SIDED|95.0|0.7|1.7|||Anderson-Gill model (robust sandwich)|||||1.70|0.70|0.7119
70882967|NCT03387813|141249446|SUPERIORITY||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|1.44||0.3484|TWO_SIDED|95.0|-4.16|1.47|||t-test, 1 sided|||||1.47|-4.16|0.3484
70882968|NCT03387813|141249446|SUPERIORITY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|1.47||0.6684|TWO_SIDED|95.0|-3.51|2.26|||t-test, 1 sided|||||2.26|-3.51|0.6684
70882969|NCT03387813|141249448|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|1.37||0.9901|TWO_SIDED|95.0|-2.68|2.71|||t-test, 1 sided|||||2.71|-2.68|0.9901
70882970|NCT03387813|141249448|SUPERIORITY||Mean Difference (Final Values)|1.48|STANDARD_ERROR_OF_MEAN|1.41||0.2947|TWO_SIDED|95.0|-1.29|4.24|||t-test, 1 sided|||||4.24|-1.29|0.2947
70882971|NCT03387813|141249450|SUPERIORITY||Mean Difference (Final Values)|4.14|STANDARD_ERROR_OF_MEAN|7.36||0.5741|TWO_SIDED|95.0|-10.32|18.6|||t-test, 1 sided|||||18.60|-10.32|0.5741
70882972|NCT03387813|141249450|SUPERIORITY||Mean Difference (Final Values)|2.93|STANDARD_ERROR_OF_MEAN|7.81||0.7077|TWO_SIDED|95.0|-12.41|18.27|||t-test, 1 sided|||||18.27|-12.41|0.7077
70882973|NCT03387813|141249453|EQUIVALENCE|Clinical equivalence was met if the lower limit of the CI of ln(HR) for the primary endpoint in Elevated NT-proBNP/BNP only vs. prior HFH only subjects is \> -0.2877 and the upper limit is \< 0.2877.|Hazard Ratio (HR)|0.46|||||TWO_SIDED|90.0|0.38|0.55||||||||0.55|0.38|
70882974|NCT03387813|141249457|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
70882975|NCT03387813|141249461|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
70882976|NCT03387813|141249465|OTHER|||||||0.0001|||||||ANOVA|||||||0.0001
70882977|NCT03387813|141249471|OTHER||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.39|0.54|||Anderson-Gill model (robust sandwich)|||||0.54|0.39|<0.0001
70882978|NCT03387813|141249472|OTHER||Hazard Ratio (HR)|0.63|||<|0.001|TWO_SIDED|95.0|0.53|0.76|||Anderson-Gill model (robust sandwich)|||||0.76|0.53|<0.001
70882979|NCT03387813|141249477|SUPERIORITY||Least Square Means Difference (T vs C)|1.53|STANDARD_ERROR_OF_MEAN|0.64||0.016|TWO_SIDED|95.0|0.29|2.78|||Mixed Models Analysis|||Comparisons of PA Systolic Pressure at 6 months between Treatment vs Control group||2.78|0.29|0.0160
70882980|NCT03387813|141249477|SUPERIORITY||Least Square Means Difference (T vs C)|0.79|STANDARD_ERROR_OF_MEAN|0.39||0.0427|TWO_SIDED|95.0|0.03|1.56|||Mixed Models Analysis|||Comparisons of PA Diastolic Pressure at 6 months between Treatment vs Control group.||1.56|0.03|0.0427
70882981|NCT03387813|141249477|SUPERIORITY||Least Square Means Difference (T vs C)|1.13|STANDARD_ERROR_OF_MEAN|0.48||0.0188|TWO_SIDED|95.0|0.19|2.08|||Mixed Models Analysis|||Comparisons of PA Mean Pressure at 6 months between Treatment vs Control group.||2.08|0.19|0.0188
70882982|NCT03387813|141249477|SUPERIORITY||Least Square Means Difference (T vs C)|0.63|STANDARD_ERROR_OF_MEAN|0.66||0.3405|TWO_SIDED|95.0|-0.66|1.92|||Mixed Models Analysis|||Comparisons of PA Systolic Pressure at 12 months between Treatment vs Control group.||1.92|-0.66|0.3405
70882983|NCT03387813|141249477|SUPERIORITY||Least Square Means Difference (T vs C)|0.2|STANDARD_ERROR_OF_MEAN|0.4||0.6174|TWO_SIDED|95.0|-0.59|0.99|||Mixed Models Analysis|||Comparisons of PA Diastolic Pressure at 12 months between Treatment vs Control group.||0.99|-0.59|0.6174
70882984|NCT03387813|141249477|SUPERIORITY||Least Square Means Difference (T vs C)|0.4|STANDARD_ERROR_OF_MEAN|0.5||0.4231|TWO_SIDED|95.0|-0.58|1.38|||Mixed Models Analysis|||Comparisons of PA Mean Pressure at 12 months between Treatment vs Control group.||1.38|-0.58|0.4231
70882985|NCT03387813|141249478|SUPERIORITY|||||||0.0214|||||||t-test, 2 sided|||Comparison of PA Systolic Pressure AUC between Treatment and Control group.||||0.0214
70882986|NCT03387813|141249478|OTHER|||||||0.1002|||||||t-test, 2 sided|||Comparison of PA Diastolic Pressure AUC between Treatment and Control group.||||0.1002
70882987|NCT03387813|141249478|OTHER|||||||0.0402|||||||t-test, 2 sided|||Comparison of PA Mean Pressure AUC between Treatment and Control group.||||0.0402
70882988|NCT03387813|141249479|SUPERIORITY||Least Square Means Difference (T vs C)|37.19|STANDARD_ERROR_OF_MEAN|75.52||0.6227|TWO_SIDED|95.0|-111.38|185.77|||Mixed Models Analysis|||Comparisons of change from baseline in BNP levels at 6 months between Treatment vs Control group||185.77|-111.38|0.6227
70882989|NCT03387813|141249480|SUPERIORITY||Least Square Means Difference (T vs C)|59.78|STANDARD_ERROR_OF_MEAN|76.87||0.4373|TWO_SIDED|95.0|-91.44|211.01|||Mixed Models Analysis|||Comparisons of change from baseline in BNP levels at 12 months between Treatment vs Control group||211.01|-91.44|0.4373
70882990|NCT03387813|141249481|SUPERIORITY||Least Square Means Difference (T vs C)|468.1|STANDARD_ERROR_OF_MEAN|256.65||0.0692|TWO_SIDED|95.0|-37.09|973.3|||Mixed Models Analysis|||Comparisons of change from baseline in NT-proBNP levels at 6months between Treatment vs Control group||973.30|-37.09|0.0692
70882991|NCT03387813|141249482|SUPERIORITY||Least Square Means Difference (T vs C)|284.67|STANDARD_ERROR_OF_MEAN|268.72||0.2903|TWO_SIDED|95.0|-244.27|813.6|||Mixed Models Analysis|||Comparisons of change from baseline in NT-proBNP levels at 12 months between Treatment vs Control group||813.60|-244.27|0.2903
70882992|NCT03387813|141249483|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.53|0.78|||Anderson-Gill model (robust sandwich)|||||0.78|0.53|<0.0001
70882993|NCT03387813|141249484|SUPERIORITY||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|95.0|0.57|0.81|||Anderson-Gill model (robust sandwich)|||||0.81|0.57|<0.0001
70882994|NCT01289847|141249500|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||one-sample Poisson rate|||For the primary efficacy analysis, the SABI rate for GAMMAPLEX and the upper bound of its one-sided 99% confidence interval (CI) were estimated by using the exact method for a one-sample Poisson rate.||||0.01
70882995|NCT01289847|141249501|SUPERIORITY_OR_OTHER|||||||0.01|ONE_SIDED|99.0|||||one-sample Poisson method|||||||0.01
70882996|NCT05876273|141249506|OTHER|The statistical analysis included general linear models (GLM), with repeated measures (NAP vs UMPC) and a covariate the 1-hour average CGM level prior to initiating either controller. This covariate was used to compute the adjusted performance differences between NAP and UMPC. The data was analyzed using the GLM procedures of IBM SPSS 28.0.||||||0.2||||||1-hour average CGM level prior to initiating either controller was included as a covariate in the analysis. This covariate was used to compute the adjusted performance differences between NAP and UMPC.|GLM with Repeated Measures|General linear models (GLM), with repeated measures (NAP vs UMPC)||||||0.2
70882997|NCT03975647|141249514|OTHER||Hazard Ratio (HR)|0.759||||0.0163|TWO_SIDED|95.0|0.607|0.95|||Log Rank||HR was calculated from Cox proportional hazards model. (line of treatment for metastatic: first versus \[vs\] other; hormone receptor status: negative vs positive; presence or history of brain metastases: yes vs no; ECOG status: 0,1 at randomization.|||0.950|0.607|0.0163
70882998|NCT03975647|141249516|OTHER||Hazard Ratio (HR)|0.639||||0.0078|TWO_SIDED|95.0|0.459|0.891|||Log Rank||HR was calculated from Cox proportional hazards model. (line of treatment for metastatic: first versus \[vs\] other; hormone receptor status: negative vs positive; presence or history of brain metastases: yes vs no; ECOG status: 0,1 at randomization.|||0.891|0.459|0.0078
70882999|NCT03975647|141249517|OTHER|||||||0.2055|||||||Cochran-Mantel-Haenszel|||||||0.2055
70883000|NCT02872116|141249527|SUPERIORITY||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|98.4|0.59|0.86|||Log Rank|||||0.86|0.59|<0.0001
70883001|NCT02872116|141249528|SUPERIORITY||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|98.0|0.56|0.81|||Log Rank|||||0.81|0.56|<0.0001
70883002|NCT03735667|141249536|NON_INFERIORITY|A Bayesian analysis based on 10,000 samples from the posterior distribution, using a piecewise exponential survival model. The criteria for non-inferiority is met if the posterior probability of non-inferiority is greater than the non-inferiority test threshold.|||||||||||||||||A Bayesian analysis was used to test the non-inferiority hypothesis for the primary endpoint using a non-inferiority margin of 8%. The pre-specified success criteria (the non-inferiority test threshold) was a posterior probability of non-inferiority greater than 97.5%. The observed posterior probability of non-inferiority was 77.9%. The posterior median percentage difference in the rate of the primary outcome was 6.63% (95% Bayesian credible interval: 3.04% to 10.20%).|||
70883003|NCT03552575|141249565|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.19|TWO_SIDED|95.0|-4.8|1.0|||Regression, Linear|Adjusted for randomized treatment, baseline value of the outcome, use of diuretics at baseline and time from randomization to cardiac MRI||||1.0|-4.8|0.19
70883004|NCT03552575|141249566|SUPERIORITY||Ratio of adjusted geometric means|0.85||||0.31|TWO_SIDED|95.0|0.63|1.16|||Regression, Linear|Adjusted for randomized treatment, baseline value of the outcome, and use of diuretics at baseline||||1.16|0.63|0.31
70883005|NCT03552575|141249567|SUPERIORITY||Ratio of adjusted geometric means|0.87||||0.41|TWO_SIDED|95.0|0.62|1.22|||Regression, Linear|Adjusted for randomized treatment, baseline value of the outcome, and use of diuretics at baseline||||1.22|0.62|0.41
70883006|NCT03552575|141249568|SUPERIORITY||Mean Difference (Final Values)|-3.1||||0.1|TWO_SIDED|95.0|-6.8|0.6|||Regression, Linear|Adjusted for randomized treatment, baseline value of the outcome, use of diuretics at baseline and time from randomization to cardiac MRI||||0.6|-6.8|0.10
70883007|NCT03552575|141249569|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.29|TWO_SIDED|95.0|-6.6|2.0|||Regression, Linear|Adjusted for randomized treatment, baseline value of the outcome, use of diuretics at baseline and time from randomization to cardiac MRI||||2.0|-6.6|0.29
70883008|NCT03552575|141249570|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.46|TWO_SIDED|95.0|-2.0|0.9|||Regression, Linear|adjusted for randomized treatment, baseline value of the outcome, use of diuretics at baseline and time from randomization to cardiac MRI||||0.9|-2.0|0.46
70963248|NCT02022085|141431000|SUPERIORITY_OR_OTHER|||||||0.69|||||||Fisher's non-parametric permutation test|||6 months: Aversiveness||||0.69
70963249|NCT02022085|141431000|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||6 months: Global||||<0.0001
70883009|NCT03552575|141249571|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.16|TWO_SIDED|95.0|-3.5|0.6|||Regression, Linear|Adjusted for randomized treatment, baseline value of the outcome, use of diuretics at baseline and time from randomization to cardiac MRI||||0.6|-3.5|0.16
70883010|NCT03552575|141249572|SUPERIORITY|||||||0.56|||||||Fisher Exact|||||||0.56
70883011|NCT04534764|141249585|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the upper confidence limit of LSM difference is below the non-inferiority margin 0.05 logMAR.|Least Square Mean Difference|-0.016|STANDARD_ERROR_OF_MEAN|0.0114|||TWO_SIDED|95.0|-0.039|0.006|||Mixed Models Analysis||LS Mean difference was calculated as Test - Control.|High Luminance Low Contrast||0.006|-0.039|
70883012|NCT04534764|141249585|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the upper confidence limit of LSM difference is below the non-inferiority margin 0.05 logMAR.|Least Square Mean Difference|0.009|STANDARD_ERROR_OF_MEAN|0.0114|||TWO_SIDED|95.0|-0.014|0.031|||Mixed Models Analysis||LS Mean difference was calculated as Test - Control.|Low Luminance High Contrast||0.031|-0.014|
70883013|NCT03583996|141249586|OTHER||Negative Likelihood Ratio (NLR)|0.293|||||TWO_SIDED|95.0|0.097|0.882||||||The performance goal for validation of DSI ≤18.3 was the upper limit of the confidence interval (CI) for negative likelihood ratio (NLR) to rule out an NLR of \>0.52. For the null and alternate hypotheses, the upper limit of the 95% CI was NLR \>0.52 and the upper limit of the 95% CI was NLR \<=0.52, respectively. The confidence level for the CI was adjusted to maintain a 1-sided type I error rate of 0.025.||0.882|0.097|
70883014|NCT03583996|141249586|OTHER||Sensitivity|0.917|||||TWO_SIDED|95.0|0.775|0.982||||||The performance goal for validation of DSI \<= 18.3 was the observed sensitivity must have been \>0.85. The confidence level for the confidence interval (CI) was adjusted to maintain a 1-sided type I error rate of 0.025.||0.982|0.775|
70883015|NCT03583996|141249587|OTHER||Odds Ratio (OR)|1.094|||<|0.0001|TWO_SIDED|95.0|1.047|1.143||The odds ratio was for a 1-unit increase in DSI based on continuous DSI.|Regression, Logistic|Unadjusted (no covariates)||||1.143|1.047|<0.0001
70883016|NCT03583996|141249587|OTHER||Odds Ratio (OR)|1.109|||<|0.0001|TWO_SIDED|95.0|1.058|1.163|||Regression, Logistic|Adjusted for demographic covariates, including age, race, sex, BMI, and ethnicity.||||1.163|1.058|<0.0001
70883017|NCT03583996|141249587|OTHER||Odds Ratio (OR)|1.092|||<|0.001|TWO_SIDED|95.0|1.041|1.145|||Regression, Logistic|Adjusted for severity of liver disease covariates, compensated cirrhosis (CP class A)||||1.145|1.041|<0.001
70883018|NCT03583996|141249587|OTHER||Odds Ratio (OR)|1.089|||<|0.001|TWO_SIDED|95.0|1.038|1.142|||Regression, Logistic|Adjusted for severity of liver disease covariates, decompensated cirrhosis (CP class B)||||1.142|1.038|<0.001
70883019|NCT03161483|141249588|SUPERIORITY||Stratified difference|11.4||||0.214|TWO_SIDED|95.0|-6.57|29.0|||Cochran-Mantel-Haenszel|||||29.00|-6.57|0.214
70883020|NCT03161483|141249588|SUPERIORITY||Stratified difference|5.0||||0.512|TWO_SIDED|95.0|-9.77|19.48|||Cochran-Mantel-Haenszel|||||19.48|-9.77|0.512
70883021|NCT03161483|141249588|SUPERIORITY||Stratified difference|19.4||||0.011|TWO_SIDED|95.0|4.12|33.42|||Cochran-Mantel-Haenszel|||||33.42|4.12|0.011
70883022|NCT03161483|141249589|SUPERIORITY||Stratified difference|10.3||||0.264|TWO_SIDED|95.0|-7.66|27.97|||Cochran-Mantel-Haenszel|||||27.97|-7.66|0.264
70883023|NCT03161483|141249589|SUPERIORITY||Stratified difference|6.5||||0.399|TWO_SIDED|95.0|-8.45|21.0|||Cochran-Mantel-Haenszel|||||21.00|-8.45|0.399
70883024|NCT03161483|141249589|SUPERIORITY||Stratified difference|19.3||||0.012|TWO_SIDED|95.0|4.01|33.36|||Cochran-Mantel-Haenszel|||||33.36|4.01|0.012
70963250|NCT02022085|141431000|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher's non-parametric permutation test|||24 months: Ease of communication||||<0.001
70883025|NCT03161483|141249590|SUPERIORITY||Stratified difference|24.0||||0.446|TWO_SIDED|95.0|-12.38|53.11|||Cochran-Mantel-Haenszel|||||53.11|-12.38|0.446
70883026|NCT03161483|141249590|SUPERIORITY||Stratified difference|5.3|||>|0.999|TWO_SIDED|95.0|-27.64|39.38|||Cochran-Mantel-Haenszel|||||39.38|-27.64|>0.999
70883027|NCT03161483|141249590|SUPERIORITY||Stratified difference|14.2||||0.488|TWO_SIDED|95.0|-19.54|44.48|||Cochran-Mantel-Haenszel|||||44.48|-19.54|0.488
70883028|NCT03161483|141249591|SUPERIORITY||Stratified difference|12.4||||0.092|TWO_SIDED|95.0|-2.74|24.07|||Cochran-Mantel-Haenszel|||||24.07|-2.74|0.092
70883029|NCT03161483|141249591|SUPERIORITY||Stratified difference|-5.3||||0.434|TWO_SIDED|95.0|-18.43|8.06|||Cochran-Mantel-Haenszel|||||8.06|-18.43|0.434
70883030|NCT03161483|141249591|SUPERIORITY||Stratified difference|8.0||||0.182|TWO_SIDED|95.0|-3.88|19.65|||Cochran-Mantel-Haenszel|||||19.65|-3.88|0.182
70883031|NCT03161483|141249592|SUPERIORITY||Stratified difference|12.1||||0.098|TWO_SIDED|95.0|-2.98|23.78|||Cochran-Mantel-Haenszel|||||23.78|-2.98|0.098
70883032|NCT03161483|141249592|SUPERIORITY||Stratified difference|-4.3||||0.521|TWO_SIDED|95.0|-17.36|8.92|||Cochran-Mantel-Haenszel|||||8.92|-17.36|0.521
70883033|NCT03161483|141249592|SUPERIORITY||Stratified difference|6.8||||0.267|TWO_SIDED|95.0|-5.24|18.55|||Cochran-Mantel-Haenszel|||||18.55|-5.24|0.267
70883034|NCT03161483|141249593|SUPERIORITY||Difference in adjusted mean|0.7||||0.116|TWO_SIDED|95.0|-0.2|1.5|||longitudinal data analysis model|||||1.5|-0.2|0.116
70883035|NCT03161483|141249593|SUPERIORITY||Difference in adjusted mean|0.7||||0.094|TWO_SIDED|95.0|-0.1|1.6|||longitudinal data analysis model|||||1.6|-0.1|0.094
70883036|NCT03161483|141249593|SUPERIORITY||Difference in adjusted mean|0.1||||0.881|TWO_SIDED|95.0|-0.6|0.8|||longitudinal data analysis model|||||0.8|-0.6|0.881
70883037|NCT03161483|141249594|SUPERIORITY||Difference in adjusted mean|1.1||||0.16|TWO_SIDED|95.0|-0.4|2.6|||longitudinal data analysis model|||||2.6|-0.4|0.160
70963251|NCT02022085|141431000|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher's non-parametric permutation test|||24 months: Background noise||||<0.001
70963252|NCT02022085|141431000|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher's non-parametric permutation test|||24 months: Reverberation||||<0.001
70963253|NCT02022085|141431000|SUPERIORITY_OR_OTHER|||||||0.84|||||||Fisher's non-parametric permutation test|||24 months: Aversiveness||||0.84
70883038|NCT03161483|141249594|SUPERIORITY||Difference in adjusted mean|1.3||||0.056|TWO_SIDED|95.0|0.0|2.6|||longitudinal data analysis model|||||2.6|0.0|0.056
70883039|NCT03161483|141249594|SUPERIORITY||Difference in adjusted mean|0.3||||0.621|TWO_SIDED|95.0|-1.0|1.6|||longitudinal data analysis model|||||1.6|-1.0|0.621
70963254|NCT02022085|141431000|SUPERIORITY_OR_OTHER||Fisher's non-parametric permutation test||||<|0.001|||||||Fisher's non-parametric permutation test|||24 months: Global||||<0.001
70883040|NCT03161483|141249596|SUPERIORITY||Difference in adjusted mean|-1.1||||0.546|TWO_SIDED|95.0|-4.7|2.5|||longitudinal data analysis model|||||2.5|-4.7|0.546
70883041|NCT03161483|141249596|SUPERIORITY||Difference in adjusted mean|-0.6||||0.681|TWO_SIDED|95.0|-3.7|2.4|||longitudinal data analysis model|||||2.4|-3.7|0.681
70883042|NCT03161483|141249596|SUPERIORITY||Difference in adjusted mean|1.4||||0.35|TWO_SIDED|95.0|-1.6|4.4|||longitudinal data analysis model|||||4.4|-1.6|0.350
70883043|NCT03161483|141249597|SUPERIORITY|\<= 7.5 mg/day|Stratified difference|0.2|||>|0.999|TWO_SIDED|95.0|-15.13|15.91|||longitudinal data analysis model|||||15.91|-15.13|>0.999
70883044|NCT03161483|141249597|SUPERIORITY|\< 10 mg/day|Stratified difference|-3.2|||>|0.999|TWO_SIDED|95.0|-17.74|13.0|||longitudinal data analysis model|||||13.00|-17.74|>0.999
70883045|NCT03161483|141249598|SUPERIORITY||Difference in adjusted means|2.8||||0.535|TWO_SIDED|95.0|-6.0|11.6|||longitudinal data analysis model|||||11.6|-6.0|0.535
70883046|NCT03161483|141249598|SUPERIORITY||Difference in adjusted means|4.2||||0.309|TWO_SIDED|95.0|-3.9|12.2|||longitudinal data analysis model|||||12.2|-3.9|0.309
70883047|NCT03161483|141249598|SUPERIORITY||Difference in adjusted means|6.5||||0.091|TWO_SIDED|95.0|-1.0|14.1|||longitudinal data analysis model|||||14.1|-1.0|0.091
70883048|NCT02767427|141249601|EQUIVALENCE|An equivalence test on data from a parallel-group design with sample sizes of 18 in the reference group and 18 in the treatment group achieves 80% power. The significance was set at 5%. The standard deviation was 1.00, and the equivalence limits were set at -1.00 and 1.00.|||||<|0.05|||||||t-test, 1 sided|Two one-sided t-tests were conducted with 18 in each group.||||||<0.05
70883049|NCT02404350|141249615|SUPERIORITY||Odds Ratio (OR)|4.02|||<|0.0001|TWO_SIDED|95.0|2.78|5.79|||Regression, Logistic|||Statistical values were calculated from a logistic regression model with treatment and randomization stratum (TNF-a status -naive or Incidence Rate) as factors and baseline weight as a covariate.||5.79|2.78|<0.0001
70883050|NCT02404350|141249615|SUPERIORITY||Odds Ratio (OR)|3.38|||<|0.0001|TWO_SIDED|95.0|2.35|4.87|||Regression, Logistic|||Statistical values were calculated from a logistic regression model with treatment and randomization stratum (TNF-a status -naive or Incidence Rate) as factors and baseline weight as a covariate.||4.87|2.35|<0.0001
70883051|NCT02404350|141249615|SUPERIORITY||Odds Ratio (OR)|4.58|||<|0.0001|TWO_SIDED|95.0|3.16|6.63|||Regression, Logistic|||Statistical values were calculated from a logistic regression model with treatment and randomization stratum (TNF-a status -naive or Incidence Rate) as factors and baseline weight as a covariate.||6.63|3.16|<0.0001
70883052|NCT02404350|141249616|SUPERIORITY||Difference in Mean|-0.61|STANDARD_ERROR_OF_MEAN|0.22||0.0061|TWO_SIDED||||||Non-parametric ANCOVA model||\*For the Statistical Test of the Hypothesis for the Secondary Outcome, The Estimation Parameter is the Standard Error of the Difference in Mean and not Standard Error of the Mean|Secukinumab 300 mg With Load compared to Placebo Estimate (for the difference in mean), SE and p-value are from a non-parametric ANCOVA model (Koch, 1998) with the change from baseline van der Heijde total modified Sharp score (or Erosion Score or Joint Space Narrowing Score) as the dependent variable, treatment and randomization stratum (TNFa status -naive or IR ) as factors, and weight and baseline van der Heijde total modified Sharp score as covariates.||||0.0061
70883053|NCT02404350|141249616|SUPERIORITY||Difference in Mean|-0.36|STANDARD_ERROR_OF_MEAN|0.13||0.0048|TWO_SIDED||||||Non-parametric ANCOVA model||\*For the Statistical Test of the Hypothesis for the Secondary Outcome, The Estimation Parameter is the Standard Error of the Difference in Mean and not Standard Error of the Mean|Secukinumab 300 mg With Load compared to Placebo Estimate (for the difference in mean), SE and p-value are from a non-parametric ANCOVA model (Koch, 1998) with the change from baseline van der Heijde total modified Sharp score (or Erosion Score or Joint Space Narrowing Score) as the dependent variable, treatment and randomization stratum (TNFa status -naive or IR ) as factors, and weight and baseline van der Heijde total modified Sharp score as covariates.||||0.0048
70883054|NCT02404350|141249616|SUPERIORITY||Difference in Mean|-0.48|STANDARD_ERROR_OF_MEAN|0.13||0.0003|||||||Non-parametric ANCOVA model||For the Statistical Test of the Hypothesis for the Secondary Outcome, The Estimation Parameter is the Standard Error of the Difference in Mean and not Standard Error of the Mean|Secukinumab 300 mg With Load compared to Placebo Estimate (for the difference in mean), SE and p-value are from a non-parametric ANCOVA model (Koch, 1998) with the change from baseline van der Heijde total modified Sharp score (or Erosion Score or Joint Space Narrowing Score) as the dependent variable, treatment and randomization stratum (TNFa status -naive or IR ) as factors, and weight and baseline van der Heijde total modified Sharp score as covariates.||||0.0003
70883055|NCT02404350|141249617|SUPERIORITY||Odds Ratio (OR)|10.15|||<|0.0001|TWO_SIDED|95.0|5.52|18.63|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.||18.63|5.52|<0.0001
70883056|NCT02404350|141249617|SUPERIORITY||Odds Ratio (OR)|11.66|||<|0.0001|TWO_SIDED|95.0|6.37|21.37|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.||21.37|6.37|<0.0001
70883057|NCT02404350|141249617|SUPERIORITY||Odds Ratio (OR)|18.06|||<|0.0001|TWO_SIDED|95.0|9.56|34.12|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.||34.12|9.56|<0.0001
70883058|NCT02404350|141249618|SUPERIORITY||Odds Ratio (OR)|4.51|||<|0.0001|TWO_SIDED|95.0|2.31|8.83|||Regression, Logistic|||"Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.~Missing responses are imputed as non-responders."||8.83|2.31|<0.0001
70883059|NCT02404350|141249618|SUPERIORITY||Odds Ratio (OR)|6.14|||<|0.0001|TWO_SIDED|95.0|3.18|11.87|||Regression, Logistic|||"Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.~Missing responses are imputed as non-responders."||11.87|3.18|<0.0001
70963255|NCT02022085|141431001|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech: Change from pre-op to 6 months||||<0.0001
70963256|NCT02022085|141431001|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Spatial: Change from pre-op to 6 months||||<0.0001
70883060|NCT02404350|141249618|SUPERIORITY||Odds Ratio (OR)|12.55|||<|0.0001|TWO_SIDED|95.0|6.43|24.48|||Regression, Logistic|||"Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.~Missing responses are imputed as non-responders."||24.48|6.43|<0.0001
70883061|NCT02404350|141249619|SUPERIORITY||Odds Ratio, log|5.37|||<|0.0001|TWO_SIDED|95.0|3.3|8.73|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.||8.73|3.30|<0.0001
70883062|NCT02404350|141249619|SUPERIORITY||Odds Ratio (OR)|6.37|||<|0.0001|TWO_SIDED|95.0|3.93|10.32|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.||10.32|3.93|<0.0001
70883063|NCT02404350|141249619|SUPERIORITY||Odds Ratio (OR)|7.43|||<|0.0001|TWO_SIDED|95.0|4.61|12.0|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.||12.00|4.61|<0.0001
70883064|NCT02404350|141249620|SUPERIORITY|Mixed model with treatment regimen, analysis visit and randomization stratum (TNF-alpha status -naïve or IR) as factors, weight and baseline score as continuous covariates, and treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure|Treatment contrast in LS mean (Change)|-0.24|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|-0.32|-0.15|||Mixed Models Analysis|LS Mean, 95% confidence interval, and p-value are from a mixed model for repeated measures (MMRM)||||-0.15|-0.32|<0.0001
70883065|NCT02404350|141249620|SUPERIORITY||Treatment Contrast in LS mean (Change)|-0.23|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|-0.32|-0.14|||Mixed Models Analysis|LS Mean, 95% confidence interval, and p-value are from a mixed model for repeated measures (MMRM)||||-0.14|-0.32|<0.0001
70883066|NCT02404350|141249620|SUPERIORITY||Treatment Contrast inj LS mean (Change)|-0.33|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|-0.42|-0.24|||Mixed Models Analysis|LS Mean, 95% confidence interval, and p-value are from a mixed model for repeated measures (MMRM)||||-0.24|-0.42|<0.0001
70883067|NCT02404350|141249621|SUPERIORITY||Treatment contrast in LS mean (Change)|-0.66|STANDARD_ERROR_OF_MEAN|0.096|<|0.0001|TWO_SIDED|95.0|-0.85|-0.47|||Mixed Models Analysis|LS Mean, 95% CI, and p-value are from a mixed model repeated measures (MMRM)||Mixed model with treatment regimen, analysis visit and randomization stratum (TNF-alpha status -naïve or IR) as factors, weight and baseline score as continuous covariates, and treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure||-0.47|-0.85|<0.0001
70883068|NCT02404350|141249621|SUPERIORITY||Treatment Contrast in LS Mean (Change)|-0.66|STANDARD_ERROR_OF_MEAN|0.096|<|0.0001|TWO_SIDED|95.0|-0.85|-0.47|||Mixed Models Analysis|LS Mean, 95% CI, and p-value are from a mixed model repeated measures (MMRM)||Mixed model with treatment regimen, analysis visit and randomization stratum (TNF-alpha status -naïve or IR) as factors, weight and baseline score as continuous covariates, and treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure||-0.47|-0.85|<0.0001
70883069|NCT02404350|141249621|SUPERIORITY||Treatment contrast in LS mean (Change)|-0.86|STANDARD_ERROR_OF_MEAN|0.096|<|0.0001|TWO_SIDED|95.0|-1.05|-0.67|||Mixed Models Analysis|LS Mean, 95% CI, and p-value are from a mixed model repeated measures (MMRM)||Mixed model with treatment regimen, analysis visit and randomization stratum (TNF-alpha status -naïve or IR) as factors, weight and baseline score as continuous covariates, and treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure||-0.67|-1.05|<0.0001
70883070|NCT02404350|141249622|SUPERIORITY||Odds Ratio (OR)|0.75||||0.225|TWO_SIDED|95.0|0.47|1.19|||Regression, Logistic|||||1.19|0.47|0.2250
70883071|NCT02404350|141249622|SUPERIORITY||Odds Ratio (OR)|0.45||||0.0004|TWO_SIDED|95.0|0.29|0.7|||Regression, Logistic|||||0.70|0.29|0.0004
70883072|NCT02404350|141249622|SUPERIORITY||Odds Ratio, log|0.44||||0.0004|TWO_SIDED|95.0|0.28|0.69|||Regression, Logistic|||||0.69|0.28|0.0004
70883073|NCT02404350|141249623|SUPERIORITY||Odds Ratio (OR)|0.37||||0.0004|TWO_SIDED|95.0|0.22|0.65|||Regression, Logistic|||||0.65|0.22|0.0004
70883074|NCT02404350|141249623|SUPERIORITY||Odds Ratio (OR)|0.34||||0.0003|TWO_SIDED|95.0|0.19|0.6|||Regression, Logistic|||||0.60|0.19|0.0003
70883075|NCT02404350|141249623|SUPERIORITY||Odds Ratio (OR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.13|0.44|||Regression, Logistic|||||0.44|0.13|<0.0001
70883076|NCT05389657|141249637|SUPERIORITY||Odds Ratio (OR)|0.617||||0.47|TWO_SIDED|95.0|0.167|2.283|||Regression, Logistic|multilevel logistic regression||We used logistic multilevel models to examine the impact of training assignment (reference = live training) on training completion, with a random intercept at the agency level. Covariates included prior level of training and/or experience in FBT, attitudes towards evidence-based practice (MPAS), perceived importance of eating disorder treatment to organization, and training preference.||2.283|0.167|0.47
70883077|NCT05389657|141249638|SUPERIORITY||adjusted group difference unstandardized|-1.268||||0.29|TWO_SIDED|95.0|-3.618|1.083|||Regression, Linear|multilevel linear regression with restricted maximum likelihood (REML) estimation||We used linear multilevel models with restricted maximum likelihood (REML) estimation to examine the impact of training assignment (reference = live training) on knowledge acquisition at post-training, with a random intercept at the agency level. Covariates included baseline FBT-KA score, prior level of training and/or experience in FBT, attitudes towards evidence-based practice (MPAS), perceived importance of eating disorder treatment to organization, and training preference.||1.083|-3.618|.29
70883078|NCT05389657|141249639|SUPERIORITY||Odds Ratio (OR)|1.16||||0.92|TWO_SIDED|95.0|0.07|19.293|||Regression, Logistic|multilevel logistic regression||We used logistic multilevel models to examine the impact of training assignment (reference = live training) on engagement in FBT consultation at 12 months, with a random intercept at the agency level. Covariates included baseline intent to seek FBT consultation, prior level of training and/or experience in FBT, attitudes towards evidence-based practice (MPAS), perceived importance of eating disorder treatment to organization, and training preference.||19.293|0.070|0.92
70883079|NCT04414553|141249643|SUPERIORITY|||||||0.29||||||Threshold for statistical significance was \<0.05|t-test, 2 sided|||This compares pre/post data.||||0.29
70883080|NCT04414553|141249644|SUPERIORITY|||||||0.35|||||||Chi-squared|||||||0.35
70883081|NCT04414553|141249645|SUPERIORITY|||||||0.21|||||||Chi-squared|||||||0.21
70883082|NCT04414553|141249646|SUPERIORITY|||||||0.018|||||||t-test, 2 sided|||||||0.018
70883083|NCT04414553|141249647|SUPERIORITY|||||||0.062|||||||t-test, 2 sided|||||||0.062
70883084|NCT04652479|141249653|OTHER|||||||0.0028||||||A p-value of \<0.05 would be considered statistically significant|Mixed effects model|||Within-group analysis||||0.0028
70883085|NCT04652479|141249653|OTHER|||||||0.0005||||||A p-value of \<0.05 would be considered statistically significant|Mixed effects model|||Within-group analysis||||0.0005
70883086|NCT04652479|141249654|OTHER|||||||0.0027||||||A p-value of \<0.05 would be considered statistically significant|Mixed effects model|||Within-group analysis||||0.0027
70883087|NCT04652479|141249654|OTHER|||||||0.0043||||||A p-value of \<0.05 would be considered statistically significant|Mixed effects model|||Within-group analysis||||0.0043
70883088|NCT04652479|141249655|OTHER|||||||0.0003||||||A p-value of \<0.05 would be considered statistically significant|Mixed effects model|||Within-group analysis||||0.0003
70883089|NCT04652479|141249655|OTHER|||||||0.0003||||||A p-value of \<0.05 would be considered statistically significant|Mixed effects model|||Within-group analysis||||0.0003
70883090|NCT04652479|141249656|OTHER|||||||0.161||||||A p-value of \<0.05 would be considered statistically significant|t-test, 2 sided|||Between-group analysis of change from baseline||||0.161
70883091|NCT04652479|141249656|OTHER||Mean Difference (Net)|-35.66||||0.201|TWO_SIDED|||||A p-value of \<0.05 would be considered statistically significant|t-test, 2 sided|||Within-group analysis of change from baseline||||0.201
70883092|NCT04652479|141249656|OTHER||Mean Difference (Net)|-67.65||||0.001|TWO_SIDED|||||A p-value of \<0.05 would be considered statistically significant|t-test, 2 sided|||Within-group analysis of change from baseline||||0.001
70883093|NCT04652479|141249657|OTHER|||||||0.145||||||A p-value of \<0.05 would be considered statistically significant|t-test, 2 sided|||Between-group analysis of change from baseline||||0.145
70883094|NCT04652479|141249657|OTHER||Mean Difference (Net)|-31.88||||0.111|TWO_SIDED|||||A p-value of \<0.05 would be considered statistically significant|t-test, 2 sided||Change in percentage|Within-group analysis of change from baseline||||0.111
70883095|NCT04652479|141249657|OTHER||Mean Difference (Net)|-53.37||||0.001|TWO_SIDED|||||A p-value of \<0.05 would be considered statistically significant|t-test, 2 sided||Change in percentage|Within-group analysis of change from baseline||||0.001
70883096|NCT05045144|141249678|OTHER|The lot-to-lot consistency is demonstrated only if two-sided 95% confidence intervals (CI) for the 3 pair-wise geometric mean ratios of RSV MAT IgG ELISA concentration falls within 0.67 and 1.5.|GMC Ratio|1.02|||||TWO_SIDED|95.0|0.92|1.13|||GMC ratio|||To demonstrate lot-to-lot consistency of the immune responses of Lot 1 and Lot 2 of the RSV MAT vaccine, as measured by ELISA in terms of IgG GMCs at Day 31.||1.13|0.92|
70883097|NCT05045144|141249678|OTHER|The lot-to-lot consistency is demonstrated only if two-sided 95% confidence intervals (CI) for the 3 pair-wise geometric mean ratios of RSV MAT IgG ELISA concentration falls within 0.67 and 1.5.|GMC ratio|0.95|||||TWO_SIDED|95.0|0.85|1.05|||GMC ratio|||To demonstrate lot-to-lot consistency of the immune responses of Lot 1 and Lot 3 of the RSV MAT vaccine, as measured by ELISA in terms of IgG GMCs at Day 31.||1.05|0.85|
70883098|NCT05045144|141249678|OTHER|The lot-to-lot consistency is demonstrated only if two-sided 95% confidence intervals (CI) for the 3 pair-wise geometric mean ratios of RSV MAT IgG ELISA concentration falls within 0.67 and 1.5.|GMC ratio|0.93|||||TWO_SIDED|95.0|0.83|1.03|||GMC ratio|||To demonstrate lot-to-lot consistency of the immune responses of Lot 2 and Lot 3 of the RSV MAT vaccine, as measured by ELISA in terms of IgG GMCs at Day 31.||1.03|0.83|
70883099|NCT05045144|141249679|NON_INFERIORITY|The non-inferiority of Flu D-QIV vaccine is demonstrated for the A/Tasmania/503/2020 (H3N2) IVR-221 strain, if the lower limit (LL) of the 95% CI on the GMT ratio (RSV MAT + Flu D-QIV vaccine divided by Flu D-QIV vaccine) is greater than 0.67 at Day 31 post vaccination.|GMC ratio|0.72|||||TWO_SIDED|95.0|0.63|0.82|||GMC ratio|||To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the ratio of HI GMTs of Flu D-QIV antibody titers against A/Tasmania/503/2020 (H3N2) IVR-221 strain at 30 days post administration (Day 31).||0.82|0.63|
70883100|NCT05045144|141249679|NON_INFERIORITY|The non-inferiority of Flu D-QIV vaccine is demonstrated for B/Washington/02/2019 strain, if the lower limit (LL) of the 95% CI on the GMT ratio (RSV MAT + Flu D-QIV vaccine divided by Flu D-QIV vaccine) is greater than 0.67 at Day 31 post vaccination.|GMC ratio|0.93|||||TWO_SIDED|95.0|0.79|1.1|||GMC ratio|||To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the ratio of HI GMTs of Flu D-QIV antibody titers against B/Washington/02/2019 strain at 30 days post administration (Day 31).||1.10|0.79|
70883101|NCT05045144|141249679|NON_INFERIORITY|The non-inferiority of Flu D-QIV vaccine is demonstrated for B/Phuket/3073/2013 strain, if the lower limit (LL) of the 95% CI on the GMT ratio (RSV MAT + Flu D-QIV vaccine divided by Flu D-QIV vaccine) is greater than 0.67 at Day 31 post vaccination.|GMC ratio|0.8|||||TWO_SIDED|95.0|0.69|0.93|||GMC ratio|||To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the ratio of HI GMTs of Flu D-QIV antibody titers against B/Phuket/3073/2013 strain at 30 days post administration (Day 31).||0.93|0.69|
70883102|NCT05045144|141249680|NON_INFERIORITY|The non-inferiority of RSV MAT vaccine is demonstrated for RSV A neutralizing antibody titers, if the LL of the 95% CI on the GMT ratio (RSV MAT + Flu D-QIV vaccine divided by RSV MAT vaccine) is greater than 0.67 at Day 31 post vaccination.|GMC ratio|0.87|||||TWO_SIDED|95.0|0.78|0.97|||GMC ratio|||To demonstrate the immunological non-inferiority of the RSV MAT vaccine when co-administered with Flu D-QIV vaccine, compared to RSV MAT vaccine given alone as measured by the ratio of GMTs of RSV A neutralizing antibody titers at 30 days post administration (Day 31).||0.97|0.78|
70883103|NCT05045144|141249681|NON_INFERIORITY|The non-inferiority of Flu D-QIV vaccine is demonstrated with respect to the SCR difference for Flu D-QIV antibody titers against A/Tasmania/503/2020 (H3N2) IVR-221 strain, if the upper limit (UL) of the 95% CI on the SCR difference (Flu D-QIV vaccine minus RSV MAT + Flu D-QIV vaccine) is less than or equal to the pre-defined clinical limit of 10% at Day 31 post vaccination.|Difference of Proportion|3.44|||||TWO_SIDED|95.0|-3.44|10.29|||Miettinen and Nurminen|||To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the difference of proportion of participants achieving seroconversion for HI antibody titers against A/Tasmania/503/2020 (H3N2) IVR-221 strain at 30 days post administration (Day 31).||10.29|-3.44|
70963257|NCT02022085|141431001|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Qualities: Change from pre-op to 6 months||||<0.0001
70963258|NCT02022085|141431001|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Speech: Change from pre-op to 24 months||||<0.0001
70963259|NCT02022085|141431001|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Spatial: Change from pre-op to 24 months||||<0.0001
70963260|NCT02022085|141431001|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Qualities: Change from pre-op to 24 months||||<0.0001
70963261|NCT03865940|141431015|SUPERIORITY|||||||0.374|TWO_SIDED|95.0||||P-values less than 0.05 considered significant.|Regression, Cox|Testing null hypothesis that guanfacine has no effect on time from injection to return to baseline.||||||0.374
70963262|NCT03865940|141431016|SUPERIORITY||||||<|0.001||||||P-values less than 0.05 considered significant.|Regression, Logistic|Analysis adjusted for pre-injection score and accounted for repeated measures. Effect of study drug was tested using a four degree-of-freedom test.||||||<0.001
70963263|NCT03865940|141431017|SUPERIORITY|||||||0.775|||||||Regression, Linear|The analysis adjusted for pre-injection score and accounted for repeat measures.The results of the analyses tested using a two degree-of-freedom test.||||||0.775
70963264|NCT03865940|141431018|SUPERIORITY|||||||0.099|||||||Regression, Linear|The analysis adjusted for pre-injection score and accounted for repeat measures.The results of the analyses tested using a two degree-of-freedom test.||||||0.099
70963265|NCT03865940|141431019|SUPERIORITY|||||||0.907|||||||Proportional Odds Regression|The analysis was not adjusted for baseline factors.||||||0.907
70963266|NCT03865940|141431020|SUPERIORITY|||||||0.373|||||||Regression, Logistic|Adjusted for use of pain medication at baseline||||||0.373
70963267|NCT02366728|141431061|OTHER|||||||0.072|||||||Log Rank|||||||0.072
70963268|NCT02366728|141431061|OTHER|||||||0.089|||||||Log Rank|||||||0.089
70963269|NCT02366728|141431062|OTHER|||||||0.0195|||||||Wilcoxon (Mann-Whitney)|||||||0.0195
70963270|NCT02366728|141431063|OTHER|||||||0.4|||||||Log Rank|||||||0.40
70963271|NCT02366728|141431064|OTHER|||||||0.4|||||||Log Rank|||||||0.40
70963272|NCT02366728|141431065|OTHER|||||||0.16|||||||Log Rank|||||||0.16
70963273|NCT02366728|141431065|OTHER|||||||0.078|||||||Log Rank|||||||0.078
70963274|NCT02366728|141431066|OTHER|||||||0.64|||||||Log Rank|||||||0.64
70963275|NCT02366728|141431067|OTHER|||||||0.29|||||||Log Rank|||||||0.29
70963276|NCT00992511|141431070|NON_INFERIORITY|Criterion for non-inferiority: upper limit (UL) of the two-sided 95% Confidence Interval (CI) for the ratio of GMT between the initial process-manufactured vaccine (GSK2340272A INI 2D Group) and (over) new process-manufactured vaccine (GSK2340272A NEW 2D Group) was less than or equal to (≤) 2.|Adjusted GMT ratio|1.06|||||TWO_SIDED|95.0|0.77|1.46||||||To evaluate the immunological non-inferiority (in terms of vaccine-homologous virus H1N1 Haemagglutinin Inhibition \[HI\] antibody geometric mean titres \[GMTs\]) of the new process-manufactured A/California/7/2009 (H1N1)v-like antigen compared to the initial process-manufactured A/California/7/2009 (H1N1)v-like antigen, 21 days after first vaccination in healthy subjects aged 18 to 60 years.||1.46|0.77|
70963277|NCT00992511|141431070|NON_INFERIORITY|Criterion for non-inferiority: upper limit (UL) of the two-sided 95% Confidence Interval (CI) for the ratio of GMT between the initial process-manufactured vaccine (GSK2340272A INI 2D Group) and (over) new process-manufactured vaccine (GSK2340272A NEW 2D Group) was less than or equal to (≤) 2.|Adjusted GMT ratio|1.17|||||TWO_SIDED|95.0|0.86|1.61||||||To evaluate the immunological non-inferiority (in terms of vaccine-homologous virus H1N1 Haemagglutinin Inhibition \[HI\] antibody geometric mean titres \[GMTs\]) of the new process-manufactured A/California/7/2009 (H1N1)v-like antigen compared to the initial process-manufactured A/California/7/2009 (H1N1)v-like antigen, 21 days after first vaccination in healthy subjects aged 18 to 60 years.||1.61|0.86|
70963278|NCT04498169|141431088|SUPERIORITY|With a sample size of up-to 20 subjects within a treatment group, the study had 80% power to demonstrate a statistically significant mean change from baseline, assuming the true effect size (mean change / SD) was 0.577 or larger (e.g. assuming the true mean change from baseline was 34.6 μm and the SD was 60 μm), a one sample t-test and a two-sided alpha = 0.10.||||||0.0021|||||||One-sample t-test (within group)|||The primary analysis used the mITT population with available data per subject at eye level (ie., ODO). Robustness analyses was also performed based on the MI methodology under different assumptions of missingness and intercurrent events (where missing data or withdrawal due to lack of efficacy or AEs were imputed using FCS regression method and missing data for all other reasons were imputed using worst within subject observation prior to the intercurrent event).||||0.0021
70963279|NCT02993523|141431089|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.465|0.723||Stratified log-rank test stratified by age (18 - \< 75, ≥ 75) and cytogenetic risk (intermediate, poor).|Log Rank||HR from Cox proportional hazards model stratified by age (18 - \< 75, ≥ 75) and cytogenetic risk (intermediate, poor).|||0.723|0.465|<0.001
70963280|NCT02993523|141431090|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by age (18 - \< 75, ≥ 75) and cytogenetic risk (intermediate, poor).||||||<0.001
70963281|NCT03694418|141431098|OTHER||Incident Rate Ratio|1.73|STANDARD_DEVIATION|0.35|<|0.05|TWO_SIDED|95.0|1.02|2.95|||Wilcoxon (Mann-Whitney)|||||2.95|1.02|<0.05
70963282|NCT02673619|141431137|OTHER||Percentage difference|25.0|||||TWO_SIDED|90.0|-21.1|75.1||||||||75.1|-21.1|
70963283|NCT02673619|141431137|OTHER||Percentage difference|25.5|||||TWO_SIDED|90.0|-10.2|59.2||||||||59.2|-10.2|
70963284|NCT02673619|141431138|OTHER||Percentage Difference|-16.2|||||TWO_SIDED|90.0|-59.7|32.0||||||||32.0|-59.7|
70963285|NCT02673619|141431138|OTHER||Percentage Difference|18.0|||||TWO_SIDED|90.0|-18.8|52.1||||||||52.1|-18.8|
70963286|NCT02673619|141431142|OTHER||Percentage Difference|16.2|||||TWO_SIDED|90.0|-32.0|59.7||||||||59.7|-32.0|
70963287|NCT02673619|141431142|OTHER||Percentage Difference|7.5|||||TWO_SIDED|90.0|-27.7|42.3||||||||42.3|-27.7|
70963288|NCT03660826|141431189|SUPERIORITY||Hazard Ratio (HR)|1.45||||0.93|TWO_SIDED|95.0|0.91|2.3||Comparing Arm II vs Arm I (reference group)|Log Rank||||Comparing Arm II vs Arm I (reference group)|2.30|0.91|0.93
70963289|NCT03660826|141431189|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.06|TWO_SIDED|95.0|0.43|1.14|||Log Rank|||Comparing Arm III vs Arm I||1.14|0.43|0.06
70963290|NCT03660826|141431189|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.62|TWO_SIDED|95.0|0.67|1.7|||Log Rank|||Comparing Arm IV vs Arm VII||1.70|0.67|0.62
70963291|NCT03660826|141431189|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.36|TWO_SIDED|95.0|0.58|1.46|||Log Rank|||Comparing Arm V vs Arm VII||1.46|0.58|0.36
70883104|NCT05045144|141249681|NON_INFERIORITY|The non-inferiority of Flu D-QIV vaccine is demonstrated with respect to the SCR difference for Flu D-QIV antibody titers against B/Washington/02/2019 strain, if the upper limit (UL) of the 95% CI on the SCR difference (Flu D-QIV vaccine minus RSV MAT + Flu D-QIV vaccine) is less than or equal to the pre-defined clinical limit of 10% at Day 31 post vaccination.|Difference of Proportion|4.15|||||TWO_SIDED|95.0|-2.04|10.32|||Miettinen and Nurminen|||To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the difference of proportion of participants achieving seroconversion for HI antibody titers against B/Washington/02/2019 strain at 30 days post administration (Day 31).||10.32|-2.04|
70883105|NCT05045144|141249681|NON_INFERIORITY|The non-inferiority of Flu D-QIV vaccine is demonstrated with respect to the SCR difference for Flu D-QIV antibody titers against B/Phuket/3073/2013 strain, if the upper limit (UL) of the 95% CI on the SCR difference (Flu D-QIV vaccine minus RSV MAT + Flu D-QIV vaccine) is less than or equal to the pre-defined clinical limit of 10% at Day 31 post vaccination.|Difference of Proportion|4.08|||||TWO_SIDED|95.0|-2.46|10.58|||Miettinen and Nurminen|||To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the difference of proportion of participants achieving seroconversion for HI antibody titers against B/Phuket/3073/2013 strain at 30 days post administration (Day 31).||10.58|-2.46|
70883106|NCT00744627|141249695|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.81|STANDARD_ERROR_OF_MEAN|0.981|<|0.001|TWO_SIDED|95.0|-5.74|-1.88||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.||P-values were tested at the 5% level of significance (ie, statistical significance if P\<0.05). To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.05, the testing procedure stopped for all subsequent endpoints.||-1.88|-5.74|<0.001
70883107|NCT00744627|141249696|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.555|<|0.001|TWO_SIDED|95.0|-3.39|-1.2||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis||||-1.20|-3.39|<0.001
70883108|NCT00744627|141249697|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.138|<|0.001|TWO_SIDED|95.0|-0.73|-0.19||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.||||-0.19|-0.73|<0.001
70883109|NCT00744627|141249698|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.96|STANDARD_ERROR_OF_MEAN|0.901||0.031|TWO_SIDED|95.0|-3.74|-0.18||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.||||-0.18|-3.74|0.031
70883110|NCT00744627|141249699|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.393|||<|0.001|TWO_SIDED|95.0|1.496|3.83||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.||||3.830|1.496|<0.001
70883111|NCT00744627|141249700|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|1.267|<|0.001|TWO_SIDED|95.0|-7.61|-2.6||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.||||-2.60|-7.61|<0.001
70883112|NCT00744627|141249701|SUPERIORITY_OR_OTHER||LS Mean Difference|8.78|STANDARD_ERROR_OF_MEAN|2.774||0.002|TWO_SIDED|95.0|3.32|14.25||SF-36 social functioning subscore was the last endpoint to be tested in the hierarchical testing sequence.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.||Results presented are for the number of participants at week 8 only.||14.25|3.32|0.002
70883113|NCT00323492|141249721|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.42||||0.034||95.0|-0.86|-0.03||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were applied.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||-0.03|-0.86|0.034
70883114|NCT00323492|141249722|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.36||||0.031||95.0|-0.67|-0.03||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum text|No adjustments were made.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||-0.03|-0.67|0.031
70883115|NCT00323492|141249723|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.1||||0.009||95.0|-0.18|-0.02||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||-0.02|-0.18|0.009
70963292|NCT03660826|141431189|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.14|TWO_SIDED|95.0|0.49|1.25|||Log Rank|||Comparing Arm VI vs VII||1.25|0.49|0.14
70963293|NCT02960113|141431221|OTHER|||||||0.98||||||Bonferroni-adjusted P-value, calculated as two times the nominal p-value because there are two primary outcomes|Chi-squared|d.f.=2||Null hypothesis: Percent experiencing nausea equal between groups||||0.98
70963294|NCT02960113|141431222|OTHER|||||||0.9||||||Bonferroni-adjusted P-value, calculated as two times the nominal p-value because there are two primary outcomes|Chi-squared|d.f.=2||Null hypothesis: Percent experiencing vomiting equal across groups||||0.90
70963295|NCT02960113|141431223|OTHER|Null hypothesis: Mean scores equal across treatment groups||||||0.026|||||||ANOVA|||||||0.026
70883116|NCT00323492|141249724|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.64|||<|0.001||95.0|-1.01|-0.27||No adjustments for multiple comparisons were made.|Wicoxon Rank Sum test|no adjustments were made.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||-0.27|-1.01|< 0.001
70883117|NCT00323492|141249725|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.1||||0.51||95.0|-0.44|0.19||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||0.19|-0.44|0.51
70883118|NCT00323492|141249726|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.79||95.0|-0.03|0.02||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||0.02|-0.03|0.79
70883119|NCT00323492|141249727|SUPERIORITY_OR_OTHER|||||||0.86||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.86
70883120|NCT00323492|141249729|SUPERIORITY_OR_OTHER|||||||0.65||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.65
70883121|NCT00323492|141249730|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||No adjustments were made.|Wilcoxon Signed Rank test|No adjustments were made.||Null Hypothesis: no indication of shift from 0 in distribution of change from baseline. Alternative Hypothesis: shift from 0 is observed in distribution of change from baseline.||||0.11
70883122|NCT00323492|141249730|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||No adjustments were made.|Wilcoxon Signed Rank test|No adjustments were made.||Null Hypothesis: no indication of shift from 0 in distribution of change from baseline. Alternative Hypothesis: shift from 0 is observed in distribution of change from baseline.||||0.34
70883123|NCT00323492|141249731|SUPERIORITY_OR_OTHER|||||||1||95.0||||No adjustments were made.|Fisher Exact|No adjustments were made.||Null Hypothesis: treatment is not associated with the observed virologic response. Alternative Hypothesis: treatment is associated with the observed virologic response||||1.00
70883124|NCT02530450|141249734|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Testing the change between two time points within each group using Wilcoxon signed rank test.||||< 0.05
70883125|NCT04681482|141249773|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.001|TWO_SIDED|95.0|0.54|0.7|||Cox Proportional Hazards Model|||Cox Proportional Hazards Model was used to compare the risk of MB between cohorts.||0.70|0.54|<0.001
70883126|NCT04681482|141249775|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.088|TWO_SIDED|95.0|0.66|1.03|||Cox Proportional Hazards Model|||Cox Proportional Hazards Model was used to compare the risk of stroke/SE between cohorts.||1.03|0.66|0.088
70883127|NCT04681482|141249777|SUPERIORITY||Hazard Ratio (HR)|0.67|||<|0.001|TWO_SIDED|95.0|0.6|0.76|||Cox Proportional Hazards Model|||Cox Proportional Hazards Model was used to compare the risk of net clinical benefit between cohorts.||0.76|0.60|<0.001
70883128|NCT03608774|141249786|SUPERIORITY||Risk Difference (RD)|0.26|||<|0.001|TWO_SIDED|95.0|0.16|0.36||Protocol pre-specified an interim analysis of the primary outcome using O'Brien-Fleming bounds to maintain an overall 5% alpha level. The trial was stopped at the interim analysis. P-value was derived using stage-wise ordering of the sample space.|Chi-squared||Protocol pre-specified an interim analysis of the primary outcome using O'Brien-Fleming bounds to maintain an overall 5% alpha level. The trial was stopped at the interim analysis. Estimates were derived using stage-wise ordering of the sample space.|||0.36|0.16|<0.001
70883129|NCT03608774|141249787|OTHER||Risk Difference (RD)|0.11|||||TWO_SIDED|95.0|0.0|0.22||||||||0.22|0.00|
70883130|NCT03608774|141249788|OTHER||Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.01|0.21||||||||0.21|-0.01|
70883131|NCT03608774|141249789|OTHER||Risk Difference (RD)|0.26|||||TWO_SIDED|95.0|0.15|0.38||||||||0.38|0.15|
70883132|NCT03608774|141249790|OTHER||Risk Difference (RD)|0.25|||||TWO_SIDED|95.0|-0.28|0.7||||||||0.70|-0.28|
70883133|NCT03608774|141249791|OTHER||Risk Difference (RD)|0.25|||||TWO_SIDED|95.0|-0.28|0.7||||||||0.70|-0.28|
70883134|NCT01713868|141249841|SUPERIORITY|GEE logistic regression accounted for within-hospital clustering, individual-level \& hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was significant, we presented results from the interaction model.||||||0.03||||||Adjusted education effect p=0.34. Adjusted mHealth effect p\<0.001. Test for interaction p=0.01. Adjusted education only effect p=0.74. Adjusted mHealth only effect p=0.02. Adjusted mHealth and education effect: p=0.03|Regression, Logistic|||Sample size provided power of detecting the effect of an individual intervention in the presence of interaction.We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p\<0.05). Allowing for 20% loss to follow-up, this led to a sample of n=1600.||||0.03
70963296|NCT02960113|141431224|OTHER|Null hypothesis: means equal across treatment groups||||||0.91|||||||ANOVA|||||||0.91
70963297|NCT02960113|141431225|OTHER|||||||0.8|||||||ANOVA|||Null hypothesis: means equal across treatment groups||||0.80
70963298|NCT02960113|141431226|OTHER|||||||0.82|||||||ANOVA|||Null hypothesis: means equal across treatment groups||||0.82
70963299|NCT02960113|141431227|OTHER|||||||0.93|||||||ANOVA|||Null hypothesis: means equal across treatment groups||||0.93
70963300|NCT02960113|141431228|OTHER|Null hypothesis: percent of vomiting equal across treatment groups||||||0.55|||||||Chi-squared|d.f.=2||||||0.55
70883135|NCT01713868|141249842|SUPERIORITY|GEE logistic regression accounted for within-hospital clustering, individual-level \& hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was not significant, we only presented main effects model.|||||<|0.001||||||Adjusted education effect: p=0.22. Adjusted mHealth effect p\<0.001. Test for interaction p=0.08.|Regression, Logistic|||Sample size provided power of detecting the effect of an individual intervention in the presence of interaction. We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p\<0.05). Allowing for 20% loss to follow-up,this led to a sample of n=1600.||||<0.001
70883136|NCT01713868|141249843|SUPERIORITY|GEE logistic regression accounted for within-hospital clustering, individual-level \& hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was not significant, we only presented main effects model.|||||<|0.001||||||Adjusted education effect p=0.07. Adjusted mHealth effect p\<0.001. Test for interaction p=0.54|Regression, Logistic|||Sample size provided power of detecting the effect of an individual intervention in the presence of interaction. We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p\<0.05). Allowing for 20% loss to follow-up, this led to a sample of n=1600.||||<0.001
70883137|NCT01713868|141249844|SUPERIORITY|GEE logistic regression accounted for within-hospital clustering, individual-level \& hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was not significant, we only presented main effects model.|||||<|0.001||||||Adjusted education effect p=0.33. Adjusted mHealth effect p\<0.001. Test for interaction p=0.29.|Regression, Logistic|||Sample size provided power of detecting the effect of an individual intervention in the presence of interaction. We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p\<0.05). Allowing for 20% loss to follow-up, this led to a sample of n=1600.||||<0.001
70883138|NCT01713868|141249845|OTHER|Causal mediation analysis|Difference in proportions|0.16|||||TWO_SIDED|95.0|||||||||We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.|||
70883139|NCT01713868|141249846|OTHER|Causal mediation analysis|Difference in proportions|0.14|||||TWO_SIDED|95.0|||||||||We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.|||
70883140|NCT01713868|141249847|OTHER|Causal mediation analysis|Difference in proportions|0.14|||||TWO_SIDED|95.0|||||||||We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.|||
70883141|NCT01713868|141249848|OTHER|Causal mediation analysis|Difference in proportions|0.15|||||TWO_SIDED|95.0|||||||||We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.|||
70883142|NCT03249779|141249856|SUPERIORITY|||||||0.0396|||||||t-test, 2 sided|||||||0.0396
70883143|NCT03249779|141249857|SUPERIORITY|||||||0.133|||||||t-test, 2 sided|||||||0.1330
70883144|NCT03314584|141249858|SUPERIORITY||||||<|0|||||||Mixed Models Analysis|F=21.662, df = 1||||||<0.000
70883145|NCT03314584|141249859|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|F=5.624, df=1||||||0.004
70883146|NCT03314584|141249860|SUPERIORITY|||||||0.046|||||||Mixed Models Analysis|F=3.092, df=1||||||0.046
70883147|NCT03314584|141249861|SUPERIORITY|||||||0.018|||||||Mixed Models Analysis|F=4.022, df=1||||||0.018
70883148|NCT03314584|141249862|SUPERIORITY|||||||0.598|||||||Mixed Models Analysis|F=0.279, df=1||||||0.598
70883149|NCT03314584|141249863|SUPERIORITY|||||||0.296|||||||Mixed Models Analysis|F=1.101, df=1||||||0.296
70883150|NCT03314584|141249864|SUPERIORITY|||||||0.033|||||||Mixed Models Analysis|F=4.672, df = 1||||||0.033
70883151|NCT03314584|141249865|SUPERIORITY|||||||0.606|||||||Mixed Models Analysis|F=0.268, df=1||||||0.606
70883152|NCT03314584|141249866|SUPERIORITY|||||||0.287|||||||Mixed Models Analysis|F=1.142, df=1||||||0.287
70963301|NCT02960113|141431229|OTHER|||||||0.71|||||||Chi-squared|d.f.=2||Null hypothesis: percent of vomiting equal across treatment groups||||0.71
70963302|NCT02960113|141431230|OTHER|||||||0.55|||||||Chi-squared|d.f.=2||Null hypothesis: percent of vomiting equal across treatment groups||||0.55
70883153|NCT03314584|141249867|SUPERIORITY|||||||0.049|||||||Mixed Models Analysis|F=4.039, df=1||||||0.049
70883154|NCT03314584|141249868|SUPERIORITY|||||||0.338|||||||Mixed Models Analysis|F=1.084, df=1||||||0.338
70883155|NCT04302389|141249873|OTHER||||||<|0.001|||||||t-test, 2 sided|||This was a within-subject comparison at two timepoints (baseline, 3 months)||||<0.001
70883156|NCT04214288|141249892|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.0167||90.0|0.42|0.82|||Log Rank|The analysis was performed using a stratified Cox Proportional Hazards model.|A hazard ratio \< 1 favours AZD9833 to be associated with a longer progression-free survival than fulvestrant.|||0.82|0.42|0.0167
70883157|NCT04214288|141249892|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.009||90.0|0.46|0.89|||Log Rank|The analysis was performed using a stratified Cox Proportional Hazards model.|A hazard ratio \< 1 favours AZD9833 to be associated with a longer progression-free survival than fulvestrant.|||0.89|0.46|0.0090
70883158|NCT04214288|141249893|SUPERIORITY||Odds Ratio (OR)|1.42||||0.4828||90.0|0.63|3.31|||Regression, Logistic|The analysis was performed using logistic regression model adjusting for prior use of CDK4/6 inhibitors and presence of lung and/or liver metastasis.|An odds ratio \> 1 favours AZD9833.|||3.31|0.63|0.4828
70883159|NCT04214288|141249893|SUPERIORITY||Odds Ratio (OR)|1.57||||0.3691||90.0|0.69|3.67|||Regression, Logistic|The analysis was performed using logistic regression model adjusting for prior use of CDK4/6 inhibitors and presence of lung and/or liver metastasis.|An odds ratio \> 1 favours AZD9833.|||3.67|0.69|0.3691
70883160|NCT04214288|141249897|SUPERIORITY||Odds Ratio (OR)|1.48||||0.2554|TWO_SIDED|90.0|0.84|2.64|||Regression, Logistic|The analysis was performed using logistic regression model adjusting for prior use of CDK4/6 inhibitors and presence of lung and/or liver metastasis.|An odds ratio \> 1 favours AZD9833.|||2.64|0.84|0.2554
70883161|NCT04214288|141249897|SUPERIORITY||Odds Ratio (OR)|1.62||||0.1658||90.0|0.91|2.89|||Regression, Logistic|The analysis was performed using logistic regression model adjusting for prior use of CDK4/6 inhibitors and presence of lung and/or liver metastasis.|An odds ratio \> 1 favours AZD9833.|||2.89|0.91|0.1658
70883162|NCT01928862|141249915|OTHER||Treatment difference|-31.3|||||TWO_SIDED|90.0|-58.8|0.8||||||Confidence interval (CI) of the difference in proportions between each Prepopik® group and PEG within each age group was calculated using the Clopper-Pearson method.||0.8|-58.8|
70883163|NCT01928862|141249915|OTHER||Treatment Difference|6.3|||||TWO_SIDED|90.0|-25.3|36.9||||||CI of the difference in proportions between each Prepopik® group and PEG within each age group was calculated using the Clopper-Pearson method.||36.9|-25.3|
70883164|NCT01928862|141249915|OTHER||Treatment Difference|-4.5|||||TWO_SIDED|90.0|-33.5|26.3||||||CI of the difference in proportions between each Prepopik® group and PEG within each age group was calculated using the Clopper-Pearson method.||26.3|-33.5|
70883165|NCT04649164|141249936|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||Paired t-tests comparing peer mentors' baseline and 16-week scores, and caregiver mentees' baseline and 16-week scores, respectively||||0.36
70883166|NCT04649164|141249938|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.30
70883167|NCT04649164|141249939|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
70883168|NCT04649164|141249940|SUPERIORITY||Mean Difference (Final Values)|0.78||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||0.04
70883169|NCT04649164|141249943|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||0.13
70883170|NCT02053753|141249947|NON_INFERIORITY_OR_EQUIVALENCE|The 2 treatments were considered bioequivalent if the 90% CIs for the ratio of the geometric means were between 0.80 and 1.25.|Ratio of Geometrc Means (CP4:CP2)|1.084|||||TWO_SIDED|90.0|0.995|1.181|||||The ratio and confidence interval of the geometric means are based on natural log scale data converted back to the original scale.|||1.181|0.995|
70883171|NCT02053753|141249948|NON_INFERIORITY_OR_EQUIVALENCE|The 2 treatments were considered bioequivalent if the 90% CIs for the ratio of the geometric means were between 0.80 and 1.25.|Ratio of Geometric Means (CP4:CP2)|1.028|||||TWO_SIDED|90.0|0.934|1.131|||||The ratio and confidence interval of the geometric means are based on natural log scale data converted back to the original scale.|||1.131|0.934|
70883172|NCT00499096|141249995|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<.05
70883173|NCT00314236|141250021|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED||||||ANCOVA|||||||0.011
70883174|NCT00314236|141250022|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||ANCOVA|||||||0.033
70883175|NCT05544786|141250035|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with water (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|113.13|||||TWO_SIDED|90.0|102.77|124.53|||||The ratios (and 90% confidence Intervals \[CIs\]) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)||124.53|102.77|
70883176|NCT05544786|141250035|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with infant formula (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|121.91|||||TWO_SIDED|90.0|110.75|134.2|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)||134.20|110.75|
70883177|NCT05544786|141250035|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|125.49|||||TWO_SIDED|90.0|114.43|137.61|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)||137.61|114.43|
70883178|NCT05544786|141250035|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fed) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|121.09|||||TWO_SIDED|90.0|110.42|132.79|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||132.79|110.42|
70883179|NCT05544786|141250036|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with water (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|113.62|||||TWO_SIDED|90.0|102.96|125.4|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)||125.40|102.96|
70963303|NCT02960113|141431231|OTHER|||||||0.2|||||||Chi-squared|d.f.=2||Null hypothesis: percent of vomiting equal across treatment groups||||0.20
70883180|NCT05544786|141250036|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with infant formula (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|122.53|||||TWO_SIDED|90.0|111.02|135.22|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)||135.22|111.02|
70883181|NCT05544786|141250036|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|126.55|||||TWO_SIDED|90.0|115.0|139.27|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)||139.27|115.00|
70883182|NCT05544786|141250036|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fed) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|122.28|||||TWO_SIDED|90.0|111.11|134.57|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||134.57|111.11|
70883183|NCT05544786|141250037|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with water (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|110.28|||||TWO_SIDED|90.0|99.01|122.82|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)||122.82|99.01|
70883184|NCT05544786|141250037|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with infant formula (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|140.97|||||TWO_SIDED|90.0|126.57|157.01|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)||157.01|126.57|
70883185|NCT05544786|141250037|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|149.83|||||TWO_SIDED|90.0|132.86|168.96|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)||168.96|132.86|
70883186|NCT05544786|141250037|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fed) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|147.05|||||TWO_SIDED|90.0|130.4|165.83|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||165.83|130.40|
70883187|NCT05544786|141250038|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with water (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|96.76|||||TWO_SIDED|90.0|87.31|107.23|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)||107.23|87.31|
70883188|NCT05544786|141250038|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with infant formula (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|86.86|||||TWO_SIDED|90.0|78.38|96.26|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)||96.26|78.38|
70883189|NCT05544786|141250038|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|99.29|||||TWO_SIDED|90.0|87.39|112.8|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)||112.80|87.39|
70883190|NCT05544786|141250038|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fed) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|79.29|||||TWO_SIDED|90.0|70.07|89.73|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||89.73|70.07|
70883191|NCT05544786|141250039|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with water (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|95.92|||||TWO_SIDED|90.0|86.45|106.44|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)||106.44|86.45|
70883192|NCT05544786|141250039|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with infant formula (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|86.5|||||TWO_SIDED|90.0|77.96|95.98|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)||95.98|77.96|
70883193|NCT05544786|141250039|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|88.29|||||TWO_SIDED|90.0|72.97|106.83|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)||106.83|72.97|
70883194|NCT05544786|141250039|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fed) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|77.49|||||TWO_SIDED|90.0|64.04|93.76|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||93.76|64.04|
70883195|NCT05544786|141250040|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with water (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|101.92|||||TWO_SIDED|90.0|87.71|118.44|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)||118.44|87.71|
70883196|NCT05544786|141250040|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with infant formula (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|92.4|||||TWO_SIDED|90.0|79.52|107.38|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)||107.38|79.52|
70883197|NCT05544786|141250040|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|97.04|||||TWO_SIDED|90.0|78.4|120.1|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)||120.10|78.40|
70883198|NCT05544786|141250040|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fed) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|70.45|||||TWO_SIDED|90.0|56.92|87.19|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||87.19|56.92|
70883199|NCT05544786|141250041|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect.|Ratio (%) of Adjusted Geometric Mean|96.5|||||TWO_SIDED|90.0|90.08|103.37|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||103.37|90.08|
70883200|NCT05544786|141250042|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect.|Ratio (%) of Adjusted Geometric Mean|96.63|||||TWO_SIDED|90.0|90.13|103.59|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||103.59|90.13|
70883201|NCT05544786|141250043|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect.|Ratio (%) of Adjusted Geometric Mean|98.15|||||TWO_SIDED|90.0|87.28|110.36|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||110.36|87.28|
70883202|NCT05544786|141250044|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect.|Ratio (%) of Adjusted Geometric Mean|78.49|||||TWO_SIDED|90.0|72.42|85.07|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||85.07|72.42|
70883203|NCT05544786|141250045|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect.|Ratio (%) of Adjusted Geometric Mean|87.77|||||TWO_SIDED|90.0|69.45|110.92|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||110.92|69.45|
70963304|NCT03434353|141431240|OTHER||Percentage Difference|-2.0|||||TWO_SIDED|95.0|-30.4|26.4|||||The percentage difference (Group 1 - Group 2) \& corresponding 2-sided 95% confidence interval (CI) were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline hepatitis B e antigen (HBeAg) status (positive,negative).|||26.4|-30.4|
70883204|NCT05544786|141250046|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect.|Ratio (%) of Adjusted Geometric Mean|72.6|||||TWO_SIDED|90.0|56.87|92.68|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||92.68|56.87|
70883205|NCT01774786|141250122|SUPERIORITY|The study was designed to have 80% power to show a significant difference with respect to the primary endpoint.|Hazard Ratio (HR)|0.84||||0.0565|TWO_SIDED|95.0|0.71|1.0||The actual p-value significance threshold required for OS was 0.0455, after alpha spent at the interim analysis was taken into account.|Stratified Log-Rank|Stratified analysis by geographic region, HER2 status, and prior gastrectomy.|HR was calculated as pertuzumab arm vs. placebo arm.|Primary Analysis. The null hypothesis is that the survival distribution of OS is the same in the two treatment arms.||1.00|0.71|0.0565
70883206|NCT01774786|141250122|OTHER|Exploratory|Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.72|0.99|||||HR was calculated as pertuzumab arm vs. placebo arm. Stratified analysis by geographic region, HER2 status, and prior gastrectomy.|Final Analysis||0.99|0.72|
70883207|NCT01774786|141250123|SUPERIORITY||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.62|0.86||As pre-specified in the protocol, a p-value was only to be calculated for PFS if OS was statistically significant.|||A stratified Cox proportional hazards regression model was used to estimate the HR between the pertuzumab arm vs. the placebo arm.|Primary Analysis||0.86|0.62|
70883208|NCT01774786|141250123|OTHER|Exploratory|Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.62|0.85|||||A stratified Cox proportional hazards regression model was used to estimate the HR between the pertuzumab arm vs. the placebo arm.|Final Analysis||0.85|0.62|
70883209|NCT01774786|141250124|OTHER|Exploratory|Difference in Objective Response|8.4|||||TWO_SIDED|95.0|0.89|15.91|||||Difference in objective response was calculated as the pertuzumab arm minus placebo arm.|Primary Analysis of Objective Response Rate||15.91|0.89|
70883210|NCT01774786|141250124|OTHER|Exploratory|Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|1.04|1.89|||||Odds ratio was calculated as the pertuzumab arm vs. placebo arm.|Primary Analysis of Objective Response Rate||1.89|1.04|
70883211|NCT01774786|141250125|OTHER|Exploratory|Difference in Objective Response|8.4|||||TWO_SIDED|95.0|0.89|15.91|||||Difference in objective response was calculated as the pertuzumab arm minus placebo arm.|Final Analysis of Objective Response Rate||15.91|0.89|
70883212|NCT01774786|141250125|OTHER|Exploratory|Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|1.04|1.89|||||Odds ratio was calculated as the pertuzumab arm vs. placebo arm.|Final Analysis of Objective Response Rate||1.89|1.04|
70883213|NCT01774786|141250126|OTHER|Exploratory|Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.64|1.06|||||HR was calculated as pertuzumab arm vs. placebo arm. Stratified analysis by geographic region, HER2 status, and prior gastrectomy.|Primary Analysis||1.06|0.64|
70883214|NCT01774786|141250126|OTHER|Exploratory|Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.62|0.98|||||HR was calculated as pertuzumab arm vs. placebo arm. Stratified analysis by geographic region, HER2 status, and prior gastrectomy.|Final Analysis||0.98|0.62|
70883215|NCT01774786|141250127|OTHER|Exploratory|Difference in Clinical Benefit Rate|3.37|||||TWO_SIDED|95.0|-2.34|9.07|||||Difference in clinical benefit rate was calculated as the pertuzumab arm minus placebo arm.|||9.07|-2.34|
70883216|NCT01774786|141250127|OTHER|Exploratory|Odds Ratio (OR)|1.27|||||TWO_SIDED|95.0|0.86|1.88|||||Odds ratio was calculated as the pertuzumab arm vs. placebo arm.|||1.88|0.86|
70883217|NCT04903249|141250148|OTHER|||||||0.137|||||||t-test, 2 sided|||||||0.137
70883218|NCT04903249|141250149|OTHER|||||||0.293|||||||t-test, 2 sided|||||||0.293
70883219|NCT04903249|141250150|OTHER|||||||0.609|||||||t-test, 2 sided|||||||0.609
70883220|NCT04903249|141250156|OTHER|||||||0.025|||||||t-test, 2 sided|||||||0.025
70883221|NCT04903249|141250157|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70883222|NCT04903249|141250158|OTHER|||||||0.327|||||||t-test, 2 sided|||||||.327
70883223|NCT04903249|141250159|OTHER|||||||0.479|||||||t-test, 2 sided|||||||0.479
70883224|NCT04903249|141250160|OTHER|||||||0.424|||||||t-test, 2 sided|||||||0.424
70883225|NCT04903249|141250161|OTHER|||||||0.279|||||||t-test, 2 sided|||||||0.279
70883226|NCT04903249|141250162|OTHER|||||||0.052|||||||t-test, 2 sided|||||||0.052
70883227|NCT03556579|141250163|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.162|||TWO_SIDED|95.0|-1.01|-0.36|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|Without Distance Filter||-0.36|-1.01|
70883228|NCT03556579|141250163|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-1.13|STANDARD_ERROR_OF_MEAN|0.162|||TWO_SIDED|95.0|-1.45|-0.81|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|Without Distance Filter||-0.81|-1.45|
70883229|NCT03556579|141250164|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-8.86|STANDARD_ERROR_OF_MEAN|2.173|||TWO_SIDED|95.0|-13.16|-4.55|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|||-4.55|-13.16|
70883230|NCT03556579|141250164|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-24.93|STANDARD_ERROR_OF_MEAN|2.173|||TWO_SIDED|95.0|-29.24|-20.62|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|||-20.62|-29.24|
70883231|NCT03556579|141250165|SUPERIORITY|"Superiority was concluded if the lower limit of the 95% confidence interval was above 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|95.0|0.15|0.23|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean Difference was calculated as Test minus Control|||0.23|0.15|
70883232|NCT03556579|141250166|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Ratio|0.55|||||TWO_SIDED|95.0|0.46|0.65|||Generalized linear mixed model|Generalized Linear mixed model with a lognormal distribution using the Kenward and Roger method for the denominator degrees of freedom.||||0.65|0.46|
70883233|NCT03556579|141250167|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|-1.07|-0.15|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean Difference was calculated as Test minus Control|||-0.15|-1.07|
70883234|NCT03556579|141250168|SUPERIORITY|"Superiority was concluded if the lower limit of the 95% confidence interval was above 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|95.0|0.14|0.23|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean Difference was calculated as Test minus Control|||0.23|0.14|
70883235|NCT03556579|141250169|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-30.56|STANDARD_ERROR_OF_MEAN|2.555|||TWO_SIDED|95.0|-31.66|-25.46|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test minus Control.|||-25.46|-31.66|
70883236|NCT03556579|141250169|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-15.38|STANDARD_ERROR_OF_MEAN|2.555|||TWO_SIDED|95.0|-20.48|-10.27|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test Minus Control.|||-10.27|-20.48|
70883237|NCT05218018|141250187|OTHER|||||||0.002|||||||t-test, 2 sided|||||||.002
70883238|NCT02120794|141250202|NON_INFERIORITY|non-inferiority test with an A1C margin of 0.4% and a significance level of 0.025 (one-sided).|Mean Difference (Net)|0.26|||||TWO_SIDED|95.0|0.125|0.395||||||||0.395|0.125|
70883239|NCT00082433|141250248|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79||||0.0005||95.0|0.69|0.9|||Log Rank|||The analysis was conducted when 903 progressions or deaths (446 in combination:457 in capecitabine) were observed in 960 participants.||.90|.69|.0005
70883240|NCT00082433|141250249|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.89|||<|0.0001||95.0|1.44|2.5|||Cochran-Mantel-Haenszel|||||2.50|1.44|<.0001
70883241|NCT00082433|141250253|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wei-Lachin|||There was a statistically significant difference between groups in change from baseline FBSI score favoring capecitabine. A mean change from baseline of 2.5 was considered a clinically meaningful difference (minimally important difference or MID). On-treatment mean changes in the FBSI did not reach the MID in either group.||||<0.0001
70883242|NCT00082433|141250254|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.1162||95.0|0.78|1.03||The test was stratified by (taxane resistance \[yes/no\], measurable disease versus non-measurable disease, prior chemotherapy for metastatic disease \[yes/no\], and anthracycline resistance \[yes/no\]).|Log Rank|The analysis was conducted at the 0.05 level and no adjustments were performed||This primary analysis was a comparison between the 2 treatment arms using a 2-sided, α=0.05 level log-rank test (to reject the null hypothesis of equality of survival). The analysis was conducted when 880 deaths (430 in combination:450 in capecitabine) were observed from the 1221 randomized participants.||1.03|.78|.1162
70883243|NCT00082433|141250254|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85||||0.0231||95.0|0.75|0.98|||Regression, Cox|||This prespecified secondary analysis was a Cox model adjusted for age, Karnofsky performance status, number of organ sites, estrogen receptor status, hepatic impairment, time from diagnosis, liver/lung metastases.||.98|.75|.0231
70883244|NCT02818218|141250276|SUPERIORITY||correlation coefficient|0.0005||||0.944|TWO_SIDED|98.3|-0.161|0.17|||Repeated measures correlation (rmcorr)||The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CVP. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CVP, and vice versa|||0.170|-0.161|0.944
70883245|NCT02818218|141250277|SUPERIORITY||correlation coefficient|0.27|||<|0.001|TWO_SIDED|98.3|0.11|0.42|||Repeated measures correlation (rmcorr)||The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CVP. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CVP, and vice versa|||0.42|0.11|<0.001
70883246|NCT02818218|141250278|SUPERIORITY||correlation coefficient|0.34|||<|0.001|TWO_SIDED|98.3|0.19|0.48|||Repeated measures correlation (rmcorr)||The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CVP. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CVP, and vice versa|||0.48|0.19|<0.001
70883247|NCT02818218|141250280|SUPERIORITY||correlation coefficient|0.07||||0.298|TWO_SIDED|98.3|-0.1|0.24|||Repeated measures correlation (rmcorr)||The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CI. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CI, and vice versa|||0.24|-0.10|0.298
70883248|NCT02818218|141250281|SUPERIORITY||correlation coefficient|0.22||||0.002|TWO_SIDED|98.3|0.05|0.37|||Repeated measures correlation (rmcorr)||The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CI. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CI, and vice versa|||0.37|0.05|0.002
70883249|NCT02818218|141250282|SUPERIORITY||correlation coefficient|0.33|||<|0.001|TWO_SIDED|98.3|0.17|0.47|||Repeated measures correlation (rmcorr)||The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CI. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CI, and vice versa|||0.47|0.17|<0.001
70883250|NCT04477304|141250283|SUPERIORITY||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|-0.12|-0.07||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Left-Censored Tobit Regression||Assuming a clinic-level intraclass correlation of 0.01, alpha 0.025, 86 clinics, and 5.5 clinicians per-clinic (N = 473), it was calculated we would have over 85% power for a one-tailed test detecting a 12% reduction in MME from baseline to intervention.||-0.07|-0.12|<0.001
70883251|NCT04477304|141250284|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|95.0|-0.23|-0.16||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Left-Censored Tobit Regression||Assuming a clinic-level intraclass correlation of 0.01, alpha 0.025, 86 clinics, and 5.5 clinicians per-clinic (N = 473), it was calculated we would have over 85% power for a one-tailed test detecting a 12% reduction in MME from baseline to intervention.||-0.16|-0.23|<0.001
70883252|NCT04477304|141250285|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|-0.1|-0.06||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||Assuming a clinic-level intraclass correlation of 0.01, alpha 0.025, 86 clinics, and 5.5 clinicians per-clinic (N = 473), it was calculated we would have over 85% power for a one-tailed test detecting a 12% reduction in MME from baseline to intervention.||-0.06|-0.10|<0.001
70883253|NCT04477304|141250286|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|-0.08|-0.03||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Left-Censored Tobit Regression||Assuming a clinic-level intraclass correlation of 0.01, alpha 0.025, 86 clinics, and 5.5 clinicians per-clinic (N = 473), it was calculated we would have over 85% power for a one-tailed test detecting a 12% reduction in MME from baseline to intervention.||-0.03|-0.08|<0.001
70883254|NCT04477304|141250287|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.392|TWO_SIDED|95.0|-0.03|-0.01||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||Assuming a clinic-level intraclass correlation of 0.01, alpha 0.025, 86 clinics, and 5.5 clinicians per-clinic (N = 473), it was calculated we would have over 85% power for a one-tailed test detecting a 12% reduction in MME from baseline to intervention.||-0.01|-0.03|0.392
70883255|NCT04477304|141250288|SUPERIORITY||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|95.0|-0.13|-0.05||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Left-Censored Tobit Regression||Assuming a clinic-level intraclass correlation of 0.01, alpha 0.025, 86 clinics, and 5.5 clinicians per-clinic (N = 473), it was calculated we would have over 85% power for a one-tailed test detecting a 12% reduction in MME from baseline to intervention.||-0.05|-0.13|<0.001
70883256|NCT00502697|141250305|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The original proposed sample size for this study was 300. This sample size was based on previous evidence that indicated that a reduction of 15% in the rate of preterm birth would be detectable with groups of 150. Because of concerns with systemic changes in the study's health care delivery environment, an interim analysis was conducted after 200 women had delivered. As a result of that analysis a decision was made to stop recruitment.||||.64
70883257|NCT00589108|141250327|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||ANOVA|||P-value for the difference between the mean maximum flexion between the three groups at 2 years post-surgery.||||0.64
70883258|NCT00589108|141250327|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||ANOVA|||P-value for the difference between the mean maximum flexion between the three groups at 5 years post-surgery.||||0.80
70883259|NCT00589108|141250328|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||ANOVA|||P-value for the difference for the Knee Society Function Score between the three groups at 5 years post-surgery.||||0.06
70883260|NCT00589108|141250329|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||ANOVA|||P-value for the difference for the Knee Society Pain Score between the three groups at 5 years post-surgery.||||0.87
70883261|NCT00589108|141250330|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||ANOVA|||P-value for the difference between the Knee Society Stair Climbing Score between the three groups at 2 years post-surgery.||||0.44
70883262|NCT00589108|141250330|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANOVA|||P-value for the difference between the Knee Society Stair Climbing Score between the three groups at 5 years post-surgery.||||0.08
70883263|NCT00589108|141250331|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||ANOVA|||P-value for the difference between the percentage of knees surviving between the three groups at 5 years post-surgery.||||0.92
70883264|NCT03722017|141250339|SUPERIORITY||Risk Ratio (RR)|0.91||||0.006|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 1 applies to the Hospital Discharge Timepoint||||0.006
70883265|NCT03722017|141250339|SUPERIORITY||Risk Ratio (RR)|0.93||||0.11|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 2 applies to the SNF Discharge Timepoint||||0.110
70883266|NCT03722017|141250339|SUPERIORITY||Risk Ratio (RR)|0.92||||0.06|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 3 applies to the 90 Day Follow-Up Timepoint||||0.060
70883267|NCT03722017|141250340|SUPERIORITY||Mean Difference (Net)|-0.049||||0.738|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 1 applies to the Hospital Discharge Timepoint||||0.738
70883268|NCT03722017|141250340|SUPERIORITY||Mean Difference (Net)|0.001||||0.995|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 2 applies to the SNF Discharge Timepoint||||0.995
70883269|NCT03722017|141250340|SUPERIORITY||Mean Difference (Net)|0.058||||0.721|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 3 applies to the 90 Day Follow Up Timepoint||||0.721
70883270|NCT03026257|141250343|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
70883271|NCT03026257|141250343|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
70883272|NCT03026257|141250343|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
70883273|NCT03026257|141250343|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
70883274|NCT03026257|141250343|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
70883275|NCT03026257|141250343|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
70883276|NCT03026257|141250343|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
70883277|NCT03026257|141250343|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
70883278|NCT01073865|141250393|NON_INFERIORITY_OR_EQUIVALENCE|The lower limit of the CI of the difference is greater than or equal to -17.5%. This non-inferiority margin was pre-defined in the study protocol.|Risk Difference (RD)|1.29|||||TWO_SIDED|95.0|-11.4|13.9|||||%PFS at 24 weeks for Zoladex 10.8mg - %PFS at 24 weeks for Zoladex 3.6mg|CI for the difference (10.8 mg-3.6 mg) in %PFS at 24 weeks calculated using the score method recommended by Newcombe et al||13.90|-11.40|
70883279|NCT01073865|141250394|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.02|||||TWO_SIDED|95.0|-15.47|9.67|||||ORR at 24 weeks for Zoladex 10.8mg - ORR at 24 weeks for Zoladex 3.6mg|CI for the difference (10.8 mg-3.6 mg) in ORR at 24 weeks calculated using the score method recommended by Newcombe et al||9.67|-15.47|
70883280|NCT03969992|141250452|SUPERIORITY|||||||0.1924||||||A closed test procedure is used to protect the type I error rate; the order of testing was: AeroFact high dose compared to control and if significant (p-value \<0.05), the AeroFact low dose was compared to the control.|Generalized estimating equation method|||||||0.1924
70883281|NCT02063737|141250458|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.3882||||0.083|TWO_SIDED|95.0|-0.8272|0.0508|||Mixed Models Analysis|adjusting for shift length|Adjusted difference between intervention groups (intervention - control) from the linear mixed model adjusting for shift length and repeated measures within individuals.|||0.0508|-0.8272|0.0830
70883282|NCT02063737|141250459|SUPERIORITY_OR_OTHER|||||||0.0114|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.0114
70883283|NCT02063737|141250460|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||ANCOVA|adjusting for the baseline measure||||||.99
70883284|NCT02063737|141250461|SUPERIORITY_OR_OTHER|||||||0.0927|TWO_SIDED||||||ANCOVA|adjusted for baseline measure||||||0.0927
70883285|NCT02063737|141250462|SUPERIORITY_OR_OTHER|||||||0.0578|TWO_SIDED||||||ANCOVA|adjusting for the baseline measure||||||0.0578
70883286|NCT02063737|141250463|SUPERIORITY_OR_OTHER|||||||0.69|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.69
70883287|NCT02063737|141250464|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.65
70883288|NCT02063737|141250465|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.95
70883289|NCT02063737|141250466|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.21
70883290|NCT02063737|141250467|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.51
70883291|NCT02063737|141250468|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.28
70883292|NCT02063737|141250469|SUPERIORITY_OR_OTHER|||||||0.093|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.0930
70883293|NCT02063737|141250470|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.56
70883294|NCT02063737|141250471|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.20
70883295|NCT03373383|141250480|SUPERIORITY||Percent reduction|17.2|||=|0.102|TWO_SIDED|95.0|-3.8|33.9||Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp(diff)), where diff was the model estimate of the log ratio between each PSL group and placebo group.||33.9|-3.8|=0.102
70883296|NCT03373383|141250480|SUPERIORITY||Percent reduction|19.1|||=|0.064|TWO_SIDED|95.0|-1.2|35.4||Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp(diff)), where diff was the model estimate of the log ratio between each PSL group and placebo group.||35.4|-1.2|=0.064
70883297|NCT03373383|141250480|SUPERIORITY||Percent reduction|19.2|||=|0.063|TWO_SIDED|95.0|-1.2|35.5||Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp(diff)), where diff was the model estimate of the log ratio between each PSL group and placebo group.||35.5|-1.2|=0.063
70883298|NCT03373383|141250480|SUPERIORITY||Percent reduction|12.4|||=|0.248|TWO_SIDED|95.0|-9.7|30.1||Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp\[diff\]), where diff was the model estimate of the log ratio between each PSL group and placebo group.||30.1|-9.7|=0.248
70883299|NCT03373383|141250481|SUPERIORITY||Odds Ratio (OR)|2.72|||=|0.081|TWO_SIDED|95.0|0.88|8.39||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo was calculated using logistic regression with categorical factors for treatment group, Region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||8.39|0.88|=0.081
70883300|NCT03373383|141250481|SUPERIORITY||Odds Ratio (OR)|2.37|||=|0.137|TWO_SIDED|95.0|0.76|7.41||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo was calculated using logistic regression with categorical factors for treatment group, Region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||7.41|0.76|=0.137
70883301|NCT03373383|141250481|SUPERIORITY||Odds Ratio (OR)|2.16|||=|0.192|TWO_SIDED|95.0|0.68|6.89||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo was calculated using logistic regression with categorical factors for treatment group, Region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||6.89|0.68|=0.192
70883302|NCT03373383|141250481|SUPERIORITY||Odds Ratio (OR)|3.14|||=|0.041|TWO_SIDED|95.0|1.05|9.42||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo was calculated using logistic regression with categorical factors for treatment group, Region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||9.42|1.05|=0.041
70883303|NCT03373383|141250485|SUPERIORITY||Odds Ratio (OR)|2.09|||=|0.045|TWO_SIDED|95.0|1.02|4.3||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||4.30|1.02|=0.045
70883304|NCT03373383|141250485|SUPERIORITY||Odds Ratio (OR)|1.91|||=|0.079|TWO_SIDED|95.0|0.93|3.93||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||3.93|0.93|=0.079
70883305|NCT03373383|141250485|SUPERIORITY||Odds Ratio (OR)|1.44|||=|0.338|TWO_SIDED|95.0|0.68|3.02||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||3.02|0.68|=0.338
70883306|NCT03373383|141250485|SUPERIORITY||Odds Ratio (OR)|1.88|||=|0.087|TWO_SIDED|95.0|0.91|3.87||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group, Region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||3.87|0.91|=0.087
70883307|NCT03373383|141250486|OTHER||Median Difference (Net)|7.4|||=|0.316|TWO_SIDED|95.0|-6.59|21.89||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value were based on the Wilcoxon-Mann-Whitney test. The Hodges-Lehmann nonparametric estimator was used to estimate the median difference between each PSL dose group versus placebo, along with the corresponding 95% CI of the estimate.||21.89|-6.59|=0.316
70963305|NCT03434353|141431240|OTHER||Percentage Difference|-24.7|||||TWO_SIDED|95.0|-49.2|-0.2|||||The percentage difference (Group 3 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative).|||-0.2|-49.2|
70883308|NCT03373383|141250486|OTHER||Median Difference (Net)|9.99|||=|0.133|TWO_SIDED|95.0|-3.15|23.26||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value were based on the Wilcoxon-Mann-Whitney test. The Hodges-Lehmann nonparametric estimator was used to estimate the median difference between each PSL dose group versus placebo, along with the corresponding 95% CI of the estimate.||23.26|-3.15|=0.133
70883309|NCT03373383|141250486|OTHER||Median Difference (Net)|8.19|||=|0.203|TWO_SIDED|95.0|-3.95|21.37||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value were based on the Wilcoxon-Mann-Whitney test. The Hodges-Lehmann nonparametric estimator was used to estimate the median difference between each PSL dose group versus placebo, along with the corresponding 95% CI of the estimate.||21.37|-3.95|=0.203
70883310|NCT03373383|141250486|OTHER||Median Difference (Net)|2.39|||=|0.784|TWO_SIDED|95.0|-13.65|17.79||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value were based on the Wilcoxon-Mann-Whitney test. The Hodges-Lehmann nonparametric estimator was used to estimate the median difference between each PSL dose group versus placebo, along with the corresponding 95% CI of the estimate.||17.79|-13.65|=0.784
70883311|NCT03317431|141250487|SUPERIORITY||||||<|0.01|||||||Regression, Linear|||Analysis the relationship between the duration of mechanical ventilation with DRD1 expression.||||<0.01
70883312|NCT03317431|141250488|SUPERIORITY||||||>|0.01|||||||Regression, Linear|||Analysis the relationship between the duration of mechanical ventilation with DRD2 expression.||||>0.01
70883313|NCT03317431|141250489|SUPERIORITY||||||>|0.01|||||||Regression, Linear|||Analysis the relationship between the duration of mechanical ventilation with TH expression.||||>0.01
70883314|NCT03317431|141250490|SUPERIORITY||||||>|0.01|||||||Regression, Linear|||Analysis the relationship between the duration of mechanical ventilation with DDC expression.||||>0.01
70883315|NCT03317431|141250491|SUPERIORITY||||||<|0.01|||||||Regression, Linear|||Analysis the relationship between the duration of mechanical ventilation with Ac-a-tubulin expression.||||<0.01
70883316|NCT04753164|141250501|OTHER|Mixed effects model for Repeated Measures: Change from baseline in the number of BE days per week = baseline number of BE days per week + sex (Male; Female) + BMI group (\< 30 ; ≥ 30 kg/m2) + treatment + visit + treatment × visit + baseline × visit.|LS Mean Difference to Placebo|0.0||||0.9992|TWO_SIDED|95.0|-0.69|0.69|||Mixed effects model f. repeated measures|||||0.69|-0.69|0.9992
70883317|NCT00694369|141250502|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||0.05 critical level was used.|ANOVA|"Step-down manner was used (p-value for 90-mg dose comparison was reported only if the p-value~for 120-mg dose comparison is significant)."||||||<0.001
70883318|NCT00694369|141250502|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||0.05 critical level was used.|ANOVA|Step-down manner was used (p-value for 90-mg dose comparison was reported only if the p-value for 120-mg dose comparison is significant)||||||<0.001
70883319|NCT00694369|141250502|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority bound (etoricoxib minus ibuprofen) is -4.45.|Difference in LS Means|0.06||||||95.0|-1.37|1.48|||||Difference in Least squares means (LS Means) (etoricoxib minus ibuprofen)|||1.48|-1.37|
70883320|NCT00694369|141250502|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority bound (etoricoxib minus ibuprofen) is -4.45.|Difference in LS Means|0.43||||||95.0|-0.73|1.6|||||Difference in LS Means (etoricoxib minus ibuprofen)|||1.60|-0.73|
70883321|NCT00694369|141250502|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority bound (etoricoxib minus cetaminophen/codeine) is -2.41.|Difference in LS Means|3.9||||||95.0|2.04|5.76|||||Difference in LS Means (etoricoxib minus acetaminophen/codeine)|||5.76|2.04|
70883322|NCT00694369|141250502|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority bound (etoricoxib minus acetaminophen/codeine) is -2.41.|Difference in LS Means|4.27||||||95.0|2.61|5.94|||||Difference in LS Means (etoricoxib minus acetaminophen/codeine)|||5.94|2.61|
70883323|NCT00694369|141250502|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.38||||||95.0|-1.8|1.05|||||Difference in LS Means (etoricoxib 120 mg minus etoricoxib 90 mg)|||1.05|-1.80|
70883324|NCT00694369|141250502|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|10.59||||||95.0|8.72|12.47|||||Difference in LS Means (ibuprofen 2400 mg minus placebo)|||12.47|8.72|
70963306|NCT03434353|141431240|OTHER||Percentage Difference|-17.8|||||TWO_SIDED|95.0|-43.7|8.2|||||The percentage difference (Group 5 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative).|||8.2|-43.7|
70883325|NCT00694369|141250502|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|6.75||||||95.0|4.53|8.97|||||Difference in LS Means (acetaminophen 2400 mg/codeine 240 mg minus placebo)|||8.97|4.53|
70883326|NCT00694369|141250503|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||0.05 critical level was used.|stratified Wilcoxon rank sum test|Step-down manner was used (p-value for 90-mg dose comparison was reported only if the p-value for 120-mg dose comparison is significant).||||||<0.001
70883327|NCT00694369|141250503|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||0.05 critical level was used.|stratified Wilcoxon rank sum test|Step-down manner was used (p-value for 90-mg dose comparison was reported only if the p-value for 120-mg dose comparison is significant)||||||<0.001
70883328|NCT00694369|141250503|SUPERIORITY_OR_OTHER_LEGACY|||||||0.161||95.0||||0.05 critical level was used.|stratified Wilcoxon rank sum test|Nominal p-value was provided in lieu of the 95% CI. Step-down manner was used, and the nominal p-value for 90-mg dose comparison was not reported.||||||0.161
70883329|NCT00694369|141250503|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||95.0||||0.05 critical level was used.|stratified Wilcoxon rank sum test|Nominal p-value was provided in lieu of the 95% CI. Step-down manner was used.||||||0.014
70883330|NCT00694369|141250503|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0||||0.05 critical level was used.|stratified Wilcoxon rank sum test|Nominal p-value was provided in lieu of the 95% CI. Step-down manner was used.||||||0.007
70883331|NCT02907359|141250614|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.6063|TWO_SIDED|95.0|0.74|1.19||OS between Guadecitabine vs Treatment Choice using stratified log-rank test. Due to pre-specified hierarchical testing plan, other endpoints were not evaluated for statistical significance.|Stratified Log-rank test|||||1.19|0.74|0.6063
70963307|NCT03434353|141431242|OTHER||Percentage Difference|-16.6|||||TWO_SIDED|95.0|-37.7|4.4|||||The percentage difference (Group 1 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative).|||4.4|-37.7|
70883332|NCT01405963|141250628|OTHER||Treatment Difference|7.65||||0.09|TWO_SIDED|95.0|-1.3|16.6|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 42 was evaluated using a repeated-measures analysis of covariance (ANCOVA) that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||16.60|-1.30|0.09
70883333|NCT01405963|141250628|OTHER||Treatment Difference|9.91||||0.02|TWO_SIDED|95.0|1.59|18.23|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||18.23|1.59|0.02
70883334|NCT01405963|141250629|OTHER||Treatment Difference|-4.35||||0.11|TWO_SIDED|95.0|-9.8|1.1|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 42 was evaluated using a repeated-measures analysis of covariance (ANCOVA) that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||1.10|-9.80|0.11
70883335|NCT01405963|141250629|OTHER||Treatment Difference|-4.66||||0.07|TWO_SIDED|95.0|-9.71|0.39|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.39|-9.71|0.07
70883336|NCT01405963|141250633|OTHER||Treatment Difference|8.57||||0.05|TWO_SIDED|95.0|0.01|17.13|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 42 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||17.13|0.01|0.05
70883337|NCT01405963|141250633|OTHER||Treatment Difference|10.27||||0.06|TWO_SIDED|95.0|-0.46|21.0|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||21.00|-0.46|0.06
70883338|NCT01405963|141250634|OTHER||Treatment Difference|-6.08||||0.03|TWO_SIDED|95.0|-11.56|-0.6|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 42 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||-0.60|-11.56|0.03
70883339|NCT01405963|141250634|OTHER||Treatment Difference|-7.44||||0.03|TWO_SIDED|95.0|-14.22|-0.66|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||-0.66|-14.22|0.03
70883340|NCT01405963|141250635|OTHER||Treatment Difference|0.33||||0.05|TWO_SIDED|95.0|-0.01|0.68|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 42 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.68|-0.01|0.05
70883341|NCT01405963|141250635|OTHER||Treatment Difference|0.39||||0.08|TWO_SIDED|95.0|-0.06|0.84|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.84|-0.06|0.08
70883342|NCT01405963|141250636|OTHER||Treatment Difference|0.28||||0.03|TWO_SIDED|95.0|0.03|0.53|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 42 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.53|0.03|0.03
70883343|NCT01405963|141250636|OTHER||Treatment Difference|0.33||||0.06|TWO_SIDED|95.0|-0.01|0.66|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.66|-0.01|0.06
70883344|NCT01405963|141250637|OTHER||Treatment Difference|0.41||||0.01|TWO_SIDED|95.0|0.12|0.7|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 42 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.70|0.12|0.01
70883345|NCT01405963|141250637|OTHER||Treatment Difference|0.42||||0.01|TWO_SIDED|95.0|0.11|0.72|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.72|0.11|0.01
70883346|NCT01405963|141250638|OTHER||Treatment Difference|0.24||||0.02|TWO_SIDED|95.0|0.04|0.45|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 42 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.45|0.04|0.02
70883347|NCT01405963|141250638|OTHER||Treatment Difference|0.18||||0.15|TWO_SIDED|95.0|-0.07|0.44|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.44|-0.07|0.15
70883348|NCT00680901|141250672|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.3492|TWO_SIDED|95.0|0.73|1.12||Stratified log-rank test was conducted stratifying for prior adjuvant/neo-adjuvant treatment use and region.|Log Rank||Pike estimator of HR was based on the stratified log rank test.|Primary Analysis: OS (PE population)||1.12|0.73|0.3492
70883349|NCT00680901|141250673|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.3244|TWO_SIDED|95.0|0.74|1.1||Stratified log-rank test was conducted stratifying for prior adjuvant/neo-adjuvant treatment use and region.|Log Rank||Pike estimator of HR was based on the stratified log rank test.|Primary Analysis: OS (ITT population)||1.10|0.74|0.3244
70883350|NCT04544293|141250689|SUPERIORITY||Mean Difference (Net)|6.0||||0.0007|TWO_SIDED|95.0|2.5|9.4|||Mixed Models Analysis|Modelled using MMRM adjusted for baseline % predicted DLCOadj, treatment, visit, region, severity stratification and treatment-visit interaction.|Difference from placebo|||9.4|2.5|0.0007
70883351|NCT04544293|141250690|SUPERIORITY||Mean Difference (Net)|6.9||||0.0008|TWO_SIDED|95.0|2.9|10.9||Modelled using MMRM adjusted for baseline % predicted DLCOadj, treatment, visit, region, severity stratification and treatment-visit interaction.|Mixed Models Analysis||Difference from Placebo|||10.9|2.9|0.0008
70883352|NCT04544293|141250691|SUPERIORITY||Mean Difference (Net)|-6.59||||0.0072|TWO_SIDED|95.0|-11.4|-1.79|||Mixed Models Analysis|||||-1.79|-11.40|0.0072
70883353|NCT04544293|141250692|SUPERIORITY||Mean Difference (Net)|-7.81||||0.0149|TWO_SIDED|95.0|-14.1|-1.52|||Mixed Models Analysis|||||-1.52|-14.10|0.0149
70883354|NCT04544293|141250693|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.0845|TWO_SIDED|95.0|-0.06|0.89|||Mixed Models Analysis|||||0.89|-0.06|0.0845
70883355|NCT04544293|141250694|SUPERIORITY||Mean Difference (Net)|-4.87||||0.1046|TWO_SIDED|95.0|-10.76|1.01|||Mixed Models Analysis|||||1.01|-10.76|0.1046
70883356|NCT04544293|141250695|SUPERIORITY||Mean Difference (Net)|-5.99||||0.1216|TWO_SIDED|95.0|-13.57|1.59|||Mixed Models Analysis|||||1.59|-13.57|0.1216
70883357|NCT04544293|141250696|SUPERIORITY||Mean Difference (Final Values)|0.55||||0.0234|TWO_SIDED|95.0|0.07|1.03|||Mixed Models Analysis||Change from baseline compared to placebo.|||1.03|0.07|0.0234
70883358|NCT04544293|141250697|SUPERIORITY||Mean Difference (Final Values)|-4.01||||0.1043|TWO_SIDED|95.0|-8.84|0.83|||Mixed Models Analysis|||||0.83|-8.84|0.1043
70883359|NCT01951157|141250703|SUPERIORITY||The exact binomial estimator|29.2|||||TWO_SIDED|95.0|13.2|48.4||||||The exact binomial estimator and its 95%CI was used. A pre-planned Bayesian supportive analysis test comparing PFS4 was performed.||48.4|13.2|
70883360|NCT01951157|141250703|SUPERIORITY||The exact binomial estimator|19.0|||||TWO_SIDED|95.0|5.7|37.9||||||The exact binomial estimator and its 95%CI was used. A pre-planned Bayesian supportive analysis test comparing PFS4 was performed||37.9|5.7|
70883361|NCT01951157|141250703|SUPERIORITY||The exact binomial estimator|28.0|||||TWO_SIDED|95.0|12.6|46.7||||||The exact binomial estimator and its 95%CI was used. A pre-planned Bayesian supportive analysis test comparing PFS4 was performed||46.7|12.6|
70883362|NCT01951157|141250704|SUPERIORITY|Pre-specified|||||=|0.3873|||||||Log Rank|||||||= 0.3873
70883363|NCT01951157|141250708|SUPERIORITY|Pre-specified|||||=|0.0177|||||||Log Rank|||||||= 0.0177
70883364|NCT01951157|141250709|SUPERIORITY_OR_OTHER_LEGACY|Pre-specified||||||0.3526|||||||Log Rank|||||||0.3526
70883365|NCT01951157|141250710|SUPERIORITY|Pre-specified||||||0.9026|||||||Wilcoxon signed ranks test repeat analys|||Changes in QoL scores over time were calculated and tested for statistical significance by means of wilcoxon signed ranks test repeat-measure analyses of variance.||||0.9026
70883366|NCT01951157|141250710|SUPERIORITY|||||||0.9862|||||||Wilcoxon signed ranks test repeat analys|||Changes in QoL scores over time were calculated and tested for statistical significance by means of wilcoxon signed ranks test repeat-measure analyses of variance.||||0.9862
70883367|NCT01951157|141250710|SUPERIORITY|||||||0.8057|||||||Wilcoxon signed ranks test repeat analys|||Changes in QoL scores over time were calculated and tested for statistical significance by means of ilcoxon signed ranks test repeat-measure analyses of variance.||||0.8057
70883368|NCT04809220|141250711|SUPERIORITY||LS Mean Difference|-0.29|||<|0.001|TWO_SIDED|95.0|-0.43|-0.14|||Mixed Models Analysis|||||-0.14|-0.43|<.001
70883369|NCT04809220|141250712|SUPERIORITY||LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.47|-0.15|||Mixed Models Analysis|||||-0.15|-0.47|<.001
70883370|NCT04809220|141250713|SUPERIORITY||Odds Ratio (OR)|1.15||||0.56|TWO_SIDED|95.0|0.71|1.87|||Generalized Linear Mixed Model (GLM)|||For HbA1c ≤6.5%||1.87|0.71|0.560
70883371|NCT04809220|141250713|SUPERIORITY||Odds Ratio (OR)|1.61||||0.028|TWO_SIDED|95.0|1.05|2.45|||Generalized Linear Mixed Model (GLM)|||For HbA1c \< 7%||2.45|1.05|0.028
70883372|NCT04809220|141250714|SUPERIORITY||LS Mean Difference|-9.4|||<|0.001|TWO_SIDED|95.0|-14.4|-4.3|||Mixed Models Analysis|||||-4.3|-14.4|<.001
70883373|NCT04809220|141250715|SUPERIORITY||LS Mean Difference|-7.2||||0.002|TWO_SIDED|95.0|-11.7|-2.7|||ANCOVA|||Morning premeal-fasting||-2.7|-11.7|0.002
70883374|NCT04809220|141250715|SUPERIORITY||LS Mean Difference|-10.1||||0.016|TWO_SIDED|95.0|-18.3|-1.9|||ANCOVA|||Morning 2-hour post meal||-1.9|-18.3|0.016
70883375|NCT04809220|141250715|SUPERIORITY||LS Mean Difference|-8.3||||0.007|TWO_SIDED|95.0|-14.2|-2.3|||ANCOVA|||Midday premeal||-2.3|-14.2|0.007
70883376|NCT04809220|141250715|SUPERIORITY||LS Mean Difference|-12.5||||0.002|TWO_SIDED|95.0|-20.5|-4.5|||ANCOVA|||Midday 2-hour post meal||-4.5|-20.5|0.002
70883377|NCT04809220|141250715|SUPERIORITY||LS Mean Difference|-3.9||||0.158|TWO_SIDED|95.0|-9.3|1.5|||ANCOVA|||Evening premeal||1.5|-9.3|0.158
70883378|NCT04809220|141250715|SUPERIORITY||LS Mean Difference|-11.3||||0.004|TWO_SIDED|95.0|-19.0|-3.7|||ANCOVA|||Evening 2-hour post meal||-3.7|-19.0|0.004
70963308|NCT03434353|141431242|OTHER||Percentage Difference|-16.9|||||TWO_SIDED|95.0|-38.1|4.3|||||The percentage difference (Group 3 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative).|||4.3|-38.1|
70883379|NCT04809220|141250716|SUPERIORITY||LS Mean Difference|-0.3||||0.213|TWO_SIDED|95.0|-0.8|0.2|||Mixed Models Analysis|||||0.2|-0.8|0.213
70883380|NCT00329407|141250720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|TWO_SIDED|95.0|-6.58|-3.14|||Mixed Models Analysis|The Dunnett-Hsu adjustment was used to correct for multiple comparisons.||This was a within subject analysis. The null hypothesis was that there would be no significant difference in least squares means values obtained for the baseline and week 10 assessment weeks.||-3.14|-6.58|<0.0001
70883381|NCT00329407|141250721|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.0|STANDARD_ERROR_OF_MEAN|2.7||0.001|ONE_SIDED|95.0||||There would a significant reduction in COWAT scores between baseline and Week 10.|Mixed Models Analysis|The Dunnett-Hsu adjustment was used to correct for multiple comparisons.||This is a within subject comparison of COWAT scores botained for the baseline session and the Week 10 session. The null hypothesis is that there would be no difference between these scores.||||0.001
70883382|NCT00978068|141250722|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.59||||0.04|TWO_SIDED|95.0|0.36|0.97|||Negative Binomial Regression||Group 1 represents the numerator for the rate ratio. Group 2 represents the denominator for the rate ratio.|We assumed that the incidence of malaria in Group 2 would be 0.70 episodes per person-year and estimated that we would need a sample of 300 participants for the study to have 80% power to show a 35% reduction in the incidence of malaria in Group 1, at a 2-sided significance level of 0.05. We then observed an incidence of malaria in Group 2 that was higher than anticipated (2.19 episodes/person-yr) and revised the sample size to 150 participants, who would be followed for at least 6 months.||0.97|0.36|0.04
70883383|NCT00978068|141250723|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Cox Proportional-Hazards|||||||0.13
70883384|NCT00978068|141250724|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.8||||0.87|TWO_SIDED|95.0|0.06|11.16|||Negative Binomial Regression||Group 1 represents the numerator for the rate ratio. Group 2 represents the denominator for the rate ratio.|We assumed that the incidence of malaria in Group 2 would be 0.70 episodes per person-year and estimated that we would need a sample of 300 participants for the study to have 80% power to show a 35% reduction in the incidence of malaria in Group 1, at a 2-sided significance level of 0.05. We then observed an incidence of malaria in Group 2 that was higher than anticipated (2.19 episodes/person-yr) and revised the sample size to 150 participants, who would be followed for at least 6 months.||11.16|0.06|0.87
70883385|NCT00978068|141250725|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.14|TWO_SIDED|95.0|0.45|1.12|||Cox Proportional-Hazards|Adjustment for repeated measures in the same patient|Group 1 represents the numerator for the hazard ratio. Group 2 represents the denominator for the hazard ratio.|||1.12|0.45|0.14
70883386|NCT00978068|141250726|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||0.004|TWO_SIDED|95.0|0.14|0.68|||Cox Proportional-Hazards|Adjustment for repeated measures in same participant.|Group 1 represents the numerator for the hazard ratio. Group 2 represents the denominator for the hazard ratio.|||0.68|0.14|0.004
70883387|NCT00978068|141250727|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41||||0.004|TWO_SIDED|95.0|0.22|0.76|||Cox Proportional-Hazards|Adjustment for repeated measures in the same patient.|Group 1 represents the numerator in the hazard ratio. Group 2 represents the denominator in the hazard ratio.|||0.76|0.22|0.004
70883388|NCT04258605|141250733|OTHER|P-values account for preoperative versus postoperative mean values at 1 and 2 years|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||"The small sample size of arm ASHCOM Shoulder System subjects - Fracture humeral stem of 2 cases is too low for a statistical analysis."||||<.0001
70883389|NCT04258605|141250734|OTHER|P-values account for preoperative versus postoperative mean values at 3-6 months, 1 year, 2 and 3 years|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||"The small sample size of arm ASHCOM Shoulder System subjects - Fracture humeral stem of 2 cases is too low for a statistical analysis."||||<0.001
70883390|NCT04258605|141250735|OTHER|P-values account for preoperative versus postoperative mean values at 3-6 months, 1, 2 and 3 years|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||"The small sample size of arm ASHCOM Shoulder System subjects - Fracture humeral stem of 2 cases is too low for a statistical analysis."||||<0.001
70883391|NCT04258605|141250736|OTHER|P-values account for preoperative versus postoperative mean values at 3-6 months, 1 year, 2 and 3 years|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||"The small sample size of arm ASHCOM Shoulder System subjects - Fracture humeral stem of 2 cases is too low for a statistical analysis."||||<0.001
70883392|NCT03200899|141250768|SUPERIORITY|||||||0.926|||||||ANCOVA|||||||0.926
70883393|NCT03200899|141250769|SUPERIORITY|||||||0.75|||||||ANCOVA|||||||0.750
70883394|NCT03200899|141250770|SUPERIORITY|||||||0.129|||||||ANCOVA|||||||0.129
70883395|NCT03200899|141250771|SUPERIORITY|||||||0.152|||||||ANCOVA|||||||0.152
70883396|NCT03200899|141250772|SUPERIORITY|||||||0.037|||||||ANCOVA|||||||0.037
70883397|NCT03200899|141250773|SUPERIORITY|||||||0.297|||||||ANCOVA|||||||0.297
70883398|NCT03200899|141250774|SUPERIORITY|||||||0.293|||||||ANCOVA|||||||0.293
70883399|NCT03200899|141250775|SUPERIORITY|||||||0.045|||||||ANCOVA|||||||0.045
70883400|NCT04646499|141250778|SUPERIORITY|||||||0.34|||||||Sign test|||||||0.34
70883401|NCT04646499|141250779|SUPERIORITY|||||||0.024|||||||Sign test|||||||0.024
70883402|NCT04646499|141250780|SUPERIORITY|||||||0.083|||||||Sign test|||||||0.083
70883403|NCT04646499|141250781|SUPERIORITY|||||||0.049|||||||Sign test|||||||0.049
70883404|NCT04646499|141250782|SUPERIORITY|||||||0.31|||||||Sign test|||||||0.31
70883405|NCT05083442|141250791|SUPERIORITY||Mean Difference (Net)|0.8||||0.19|TWO_SIDED|95.0|-0.4|1.9|||ANCOVA||Estimated difference between groups from analysis of covariance with baseline fat mass included as the covariate.|Groups were compared using analysis of covariance with baseline included as the covariate.||1.9|-0.4|0.19
70883406|NCT05083442|141250792|SUPERIORITY||Mean Difference (Net)|0.3||||0.745|TWO_SIDED|95.0|-1.5|2.1|||ANCOVA||Estimated difference between groups from analysis of covariance with baseline fat mass included as the covariate.|Groups were compared using analysis of covariance with baseline included as the covariate.||2.1|-1.5|0.745
70883407|NCT03711162|141250811|SUPERIORITY||Least square (LS) mean difference|22.7|STANDARD_ERROR_OF_MEAN|38.12||0.5525|TWO_SIDED|95.0|-52.3|97.6||P-value: based on random coefficient regression model (linear slope model) on FVC values.|Coefficient Regression Model|Treatment effect determined by using estimated slopes for each treatment group on basis of time-by-treatment interaction term from the mixed model.||||97.6|-52.3|0.5525
70883408|NCT03711162|141250811|SUPERIORITY||LS mean difference|-26.7|STANDARD_ERROR_OF_MEAN|37.53||0.4776|TWO_SIDED|95.0|-100.5|47.1||P-value: based on random coefficient regression model (linear slope model) on FVC values.|Coefficient Regression Model|Treatment effect was determined by using estimated slopes for each treatment group on basis of time-by-treatment interaction term from mixed model.||||47.1|-100.5|0.4776
70883409|NCT03711162|141250812|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9648|TWO_SIDED|95.0|0.56|1.74|||Regression, Logistic|||||1.74|0.56|0.9648
70883410|NCT03711162|141250812|SUPERIORITY||Odds Ratio (OR)|1.05||||0.853|TWO_SIDED|95.0|0.6|1.84|||Regression, Logistic|||||1.84|0.60|0.8530
70883411|NCT03711162|141250813|SUPERIORITY||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.5|2.05|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards for time to respiratory-related hospitalization.|||2.05|0.50|
70883412|NCT03711162|141250813|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.47|1.88|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards for time to respiratory-related hospitalization.|||1.88|0.47|
70883413|NCT03711162|141250814|SUPERIORITY||LS mean difference|-0.5||||0.785|TWO_SIDED|95.0|-4.4|3.3|||Mixed Models Analysis||LS mean difference (95% CI) per treatment group with treatment, time (categorical), treatment-by-time interaction, stratum and baseline SGRQ total score as fixed effects and participant as random effect.|||3.3|-4.4|0.7850
70883414|NCT03711162|141250814|SUPERIORITY||LS mean difference|0.3||||0.8617|TWO_SIDED|95.0|-3.4|4.1|||Mixed Models Analysis||LS mean difference (95% CI) per treatment group with treatment, time (categorical), treatment-by-time interaction, stratum and baseline SGRQ total score as fixed effects and participant as random effect.|||4.1|-3.4|0.8617
70883415|NCT03711162|141250815|SUPERIORITY||LS Mean difference|19.4|STANDARD_ERROR_OF_MEAN|33.68|||TWO_SIDED|95.0|-46.9|85.7|||||The treatment effect was determined by using estimated slopes for each study group on the basis of the time-by-treatment interaction term from the mixed model.|||85.7|-46.9|
70963309|NCT03434353|141431242|OTHER||Percentage Difference|-16.7|||||TWO_SIDED|95.0|-37.9|4.4|||||The percentage difference (Group 5 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative).|||4.4|-37.9|
70883416|NCT03711162|141250815|SUPERIORITY||LS Mean difference|-29.1|STANDARD_ERROR_OF_MEAN|32.95|||TWO_SIDED|95.0|-93.9|35.8|||||The treatment effect was determined by using estimated slopes for each study group on the basis of the time-by-treatment interaction term from the mixed model.|||35.8|-93.9|
70883417|NCT03711162|141250816|SUPERIORITY||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.68|1.95|||||Odds ratio and 95% confidence interval originated from a logistic regression.|||1.95|0.68|
70883418|NCT03711162|141250816|SUPERIORITY||Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.74|2.09|||||Odds ratio and 95% confidence interval originated from a logistic regression.|||2.09|0.74|
70883419|NCT03711162|141250817|SUPERIORITY||LS mean difference|3.7|||||TWO_SIDED|95.0|-11.5|19.0|||||The treatment effect was determined by using estimated least square mean difference between each active treatment group and placebo from the mixed model.|||19.0|-11.5|
70883420|NCT03711162|141250817|SUPERIORITY||LS mean difference|2.9|||||TWO_SIDED|95.0|-11.1|16.8|||||The treatment effect was determined by using estimated least square mean difference between each active treatment group and placebo from the mixed model.|||16.8|-11.1|
70883421|NCT03711162|141250818|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.65|1.78|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause hospitalization.|||1.78|0.65|
70883422|NCT03711162|141250818|SUPERIORITY||Hazard Ratio (HR)|1.23|||||TWO_SIDED|95.0|0.76|1.98|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause hospitalization.|||1.98|0.76|
70883423|NCT03711162|141250821|SUPERIORITY||Hazard Ratio (HR)|1.29|||||TWO_SIDED|95.0|0.44|3.81|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first acute IPF exacerbation.|||3.81|0.44|
70883424|NCT03711162|141250821|SUPERIORITY||Hazard Ratio (HR)|1.21|||||TWO_SIDED|95.0|0.42|3.5|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first acute IPF exacerbation.|||3.50|0.42|
70883425|NCT03711162|141250822|SUPERIORITY||Hazard Ratio (HR)|1.64|||||TWO_SIDED|95.0|0.66|4.08|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality or hospitalization for non-elective lung transplant.|||4.08|0.66|
70883426|NCT03711162|141250822|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.36|2.61|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality or hospitalization for non-elective lung transplant.|||2.61|0.36|
70883427|NCT03711162|141250823|SUPERIORITY||Hazard Ratio (HR)|1.64|||||TWO_SIDED|95.0|0.66|4.08|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality, hospitalization for non-elective lung transplant or hospitalization for qualifying for lung transplant.|||4.08|0.66|
70883428|NCT03711162|141250823|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.36|2.61|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality, hospitalization for non-elective lung transplant or hospitalization for qualifying for lung transplant.|||2.61|0.36|
70883429|NCT03711162|141250824|SUPERIORITY||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.59|1.91|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all-cause mortality or hospitalization that meets \>=10% absolute decline in %FVC or respiratory-related hospitalization.|||1.91|0.59|
70883430|NCT03711162|141250824|SUPERIORITY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.43|1.46|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all-cause mortality or hospitalization that meets \>=10% absolute decline in %FVC or respiratory-related hospitalization.|||1.46|0.43|
70883431|NCT03711162|141250825|SUPERIORITY||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.59|1.91|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to all-cause mortality or respiratory-related hospitalizations.|||1.91|0.59|
70883432|NCT03711162|141250825|SUPERIORITY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.43|1.46|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to all-cause mortality or respiratory-related hospitalizations.|||1.46|0.43|
70883433|NCT03034954|141250849|OTHER|||||||0.3||||||Reported p-value represents Time (baseline to post-tDCS) x Condition (Active or Sham) interaction for all OLTT Accuracy Measures. If the multivariate statistic is not significant no univariate statistical analyses are completed.|Repeated Measures ANOVA|repeated measures (OLTT baseline and post-tDCS); between-subjects (active vs. sham)||We used a multivariate statistic to compare OLTT means (Free Recall Total Error, Free Recall Average Error, Cued Recall Total Error, Cued Recall Average Error, Recognition Total Correct) at baseline (Version B) to post HD-tDCS OLTT means (Version C), by groups (active vs. sham). The overall statistic represents the simultaneous comparison of baseline OLTT measures to post HD-tDCS OLTT measures.||||.300
70883434|NCT03034954|141250851|OTHER|||||||0.044||||||Statistic represents the interaction between Time (baseline to post-tDCS) by Condition (Active vs. Sham).|Repeated Measures ANOVA|||A Repeated Measures ANOVA was used to compare baseline OLTT (Version B) to post-tDCS OLTT (Version C) across the treatment groups (Active vs. Sham). The multivariate analyses included OLTT Response Times (i.e., Free Recall Average Response Time, Cued Recall Average Response Time, Recognition Average Response Time)||||.044
70883435|NCT03034954|141250851|OTHER|||||||0.006|||||||Repeated Measures ANOVA|||Univariate analysis of the OLTT Free Recall Average Time to Respond following significant multivariate repeated measures ANOVA comparing baseline OLTT (Version B) to post-tDCS OLTT (Version C) across the treatment groups (Active vs. Sham).||||.006
70883436|NCT03034954|141250854|OTHER|||||||0.15|||||||Repeated Measures ANOVA|||Univariate analysis of the OLTT Cued Recall Average Time to Respond following significant multivariate repeated measures ANOVA comparing baseline OLTT (Version B) to post-tDCS OLTT (Version C) across the treatment groups (Active vs. Sham).||||.15
70883437|NCT03034954|141250856|OTHER|||||||0.3|||||||Repeated Measures ANOVA|||Univariate analysis of the OLTT Recognition Average Time to Respond following significant multivariate repeated measures ANOVA comparing baseline OLTT (Version B) to post-tDCS OLTT (Version C) across the treatment groups (Active vs. Sham).||||.3
70883438|NCT03034954|141250861|OTHER|||||||0.45|||||||MANOVA|||A Multivariate ANOVA was used to compare Active vs. Sham groups on discriminability measures (i.e. 0-back d', 2-back d', semantic 2-back d') and calculated working memory measures (i.e., 2-back d' minus 0-back d', semantic 2-back d' minus 0-back d').||||.450
70883439|NCT03034954|141250862|OTHER|||||||0.078|||||||Chi-squared|||Chi-squared tests were conducted to determine group differences in actual condition assignment vs. estimated/perceived condition||||.078
70883440|NCT03034954|141250863|OTHER|||||||0.233|||||||Fisher Exact|||||||.233
70883441|NCT03034954|141250865|OTHER|||||||0.6|||||||Fisher Exact|||||||.600
70883442|NCT03034954|141250866|OTHER|||||||0.999|||||||Fisher Exact|||||||.999
70883443|NCT03034954|141250867|OTHER|||||||0.281|||||||Fisher Exact|||||||.281
70883444|NCT03034954|141250868|OTHER|||||||0.082|||||||Fisher Exact|||||||.082
70883445|NCT03034954|141250869|OTHER|||||||0.49|||||||Fisher Exact|||||||.490
70883446|NCT03034954|141250870|OTHER|||||||0.488|||||||Fisher Exact|||||||.488
70883447|NCT03034954|141250871|OTHER|||||||0.219|||||||Fisher Exact|||||||.219
70883448|NCT05228470|141250893|OTHER|Null hypothesis of ORR by BICR was 30%.||||||0.0076|||||||Exact binomial test|||||||0.0076
70883449|NCT00136084|141250919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.624||||0.1559||95.0|0.832|3.205||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.041 so that the overall level of the study is maintained at 0.05 across the 4 interim analyses and the final analysis.|Cochran-Mantel-Haenszel|The p-value was computed using a Monte Carlo approximation (10000 permutations) to an exact, risk-group stratified, test.|The odds ratio is defined as the ratio of the odds that a LDAC patient is MRD positive to the odds that a HDAC patient is MRD positive.|The study was designed to test the null hypothesis that HDAC and LDAC result in the same proportion of patients with positive MRD after 22 days. Power calculations indicate that enrollment of a total of 186 MRD-evaluable patients in a 5-stage O'Brien-Fleming group sequential design gives 80% power at the 5% level to detect a change in the MRD-positive proportion from 0.50 to 0.30. The design was developed using East statistical software.||3.205|.832|.1559
70883450|NCT00136084|141250920|SUPERIORITY_OR_OTHER||Binomial proportion|0.733||||||95.0|0.449|0.922|||Binomial proportion|||Estimate of the proportion of negative minimal residual disease.||.922|.449|
70883451|NCT00136084|141250921|SUPERIORITY_OR_OTHER||Binomial proportion|0.931||||||95.0|0.772|0.992|||Binomial proportion|||||.992|.772|
70883452|NCT00136084|141250922|SUPERIORITY_OR_OTHER||Binomial proportion|0.9||||||95.0|0.735|0.979|||Binomial proportion|||||.979|.735|
70883453|NCT00136084|141250924|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||t-test, 2 sided|||||||0.60
70883454|NCT00136084|141250925|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.0139||||0.2287|TWO_SIDED|95.0|-0.0365|0.00873|||Regression, Logistic|||||0.00873|-0.0365|0.2287
70883455|NCT03244865|141250936|NON_INFERIORITY|Non-inferiority will be verified if the RMSE between the two systems is within 7 BPM. A complete power analysis was not included as this is a pilot study.|||||<|0.1||||||Pilot Study|t-test, 2 sided|||There is only one ARM in the study. Standard monitoring and LaborView monitoring will be collected simultaneously and analyzed.||||<.1
70883456|NCT00394212|141250937|SUPERIORITY_OR_OTHER|||||||0.066||95.0||||P-value from non-parametric Mann-Whitney-Wilcoxon test comparing treatments.|Wilcoxon (Mann-Whitney)|||Based on a 2-group test of means for unequal variance and unequal sample size (2:1 randomization ratio) with alpha = 0.05 and a power of 80%, the sample size required was 132; 88 subjects in the Transoral Suturing arm and 44 in the Sham Endoscopy arm. The study was prematurely discontinued due to reasons unrelated to safety and effectiveness and therefore was underpowered for evaluation of the primary and secondary hypotheses.||||0.066
70883457|NCT00394212|141250938|SUPERIORITY_OR_OTHER|||||||0.317||95.0||||P-value from two-sided Fisher's exact test comparing percents achieving 15% EWL at 6 months for the two treatments.|Fisher Exact|||||||0.317
70883458|NCT00394212|141250939|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-value from two-sided Fisher's exact test comparing percents achieved for the two treatments.|Fisher Exact|||||||0.019
70883459|NCT00394212|141250940|SUPERIORITY_OR_OTHER|||||||0.174||95.0||||P-value from two-sided Fisher's exact test comparing percents achieved for the two treatments.|Fisher Exact|||||||0.174
70883460|NCT03240133|141250943|SUPERIORITY|Comparisons were performed separately at each time point using a mixed effect linear model including treatment, period and sequence as fixed effects, subject within sequence as a random effect, and predose 3-symptom composite VAS score as a covariate.|Difference in Least Square Means|-6.98||||0.0024|TWO_SIDED|95.0|-11.37|-2.6|||Mixed effect linear model|||Change in HAE attack symptoms from pre-dose to 4 hours post-dose was assessed following treatment with either 750mg berotralstat or placebo.||-2.6|-11.37|0.0024
70883461|NCT03240133|141250943|SUPERIORITY|Comparisons were performed separately at each time point using a mixed effect linear model including treatment, period and sequence as fixed effects, subject within sequence as a random effect, and predose 3-symptom composite VAS score as a covariate.|Difference in Least Square Means|-2.1||||0.6424|TWO_SIDED|95.0|-11.49|7.29|||Mixed effect linear model|||Change in HAE attack symptoms from pre-dose to 4 hours post-dose was assessed following treatment with either 500mg berotralstat or placebo.||7.29|-11.49|0.6424
70883462|NCT03240133|141250943|SUPERIORITY|Comparisons were performed separately at each time point using a mixed effect linear model including treatment, period and sequence as fixed effects, subject within sequence as a random effect, and predose 3-symptom composite VAS score as a covariate.|Difference in Least Square Means|0.57||||0.8283|TWO_SIDED|95.0|-4.9|6.03|||Mixed effect linear model|||Change in HAE attack symptoms from pre-dose to 4 hours post-dose was assessed following treatment with either 250mg berotralstat or placebo.||6.03|-4.9|0.8283
70883463|NCT03240133|141250944|SUPERIORITY||Odds Ratio (OR)|0.196||||0.0029|TWO_SIDED|95.0|0.069|0.559|||logistic mixed effect model|||Analyses were performed using a generalized logistic model including treatment, period and sequence as fixed effects, and subject within sequence as a random effect. The odds of a berotralstat 750 mg-treated-attack requiring SOC-Rx was 0.196 that of a placebo attack.||0.559|0.069|0.0029
70883464|NCT03240133|141250944|SUPERIORITY||Odds Ratio (OR)|0.472||||0.4048|TWO_SIDED|95.0|0.074|2.988|||logistic mixed effect model|||Analyses were performed using a generalized logistic model including treatment, period and sequence as fixed effects, and subject within sequence as a random effect. The odds of a berotralstat 500 mg-treated-attack requiring SOC-Rx was 0.472 that of a placebo attack.||2.988|0.074|0.4048
70883465|NCT03240133|141250944|SUPERIORITY||Odds Ratio (OR)|0.587||||0.5984|TWO_SIDED|95.0|0.073|4.733|||logistic mixed effect model|||Analyses were performed using a generalized logistic model including treatment, period and sequence as fixed effects, and subject within sequence as a random effect. The odds of a berotralstat 250 mg-treated-attack requiring SOC-Rx was 0.587 that of a placebo attack.||4.733|0.073|0.5984
70883466|NCT00116831|141250990|SUPERIORITY_OR_OTHER||Mean diff (RSG-GLP) for atheroma volume|-4.58||||||95.0||||||||||||
70883467|NCT00116831|141250991|SUPERIORITY_OR_OTHER||Mean diff (RSG-GLP) for lumen volume|0.32||||||95.0||||||||||||
70883468|NCT00116831|141250992|SUPERIORITY_OR_OTHER||Mean diff (RSG-GLP) for vessel volume|-3.56||||||95.0||||||||||||
70883469|NCT00116831|141250994|SUPERIORITY_OR_OTHER||Mean diff (RSG-GLP) for atheroma area|-0.13||||||95.0||||||||||||
70883470|NCT00116831|141250995|SUPERIORITY_OR_OTHER||Mean diff (RSG-GLP) for lumen area|0.02||||||95.0||||||||||||
70883471|NCT00116831|141250996|SUPERIORITY_OR_OTHER||Mean diff (RSG-GLP) for vessel area|-0.11||||||95.0||||||||||||
70883472|NCT00116831|141250999|SUPERIORITY_OR_OTHER||Model adjusted mean diff. (RSG-GLP)|-0.64||||0.1221||95.0|-1.457|0.173|||ANCOVA|||||0.173|-1.457|0.1221
70883473|NCT00116831|141251000|SUPERIORITY_OR_OTHER||Model adjusted mean diff. (RSG-GLP)|-5.12||||||95.0||||||||||||
70883474|NCT00116831|141251002|SUPERIORITY_OR_OTHER||Model adjusted mean diff. (RSG-GLP)|-1.72||||||95.0||||||||||||
70883475|NCT00116831|141251004|SUPERIORITY_OR_OTHER||Model adjusted mean diff. (RSG-GLP)|-0.11||||||95.0||||||||||||
70883476|NCT00116831|141251005|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-0.1||||||95.0||||||||||||
70883477|NCT00116831|141251006|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-0.88||||||95.0||||||||||||
70883478|NCT00116831|141251007|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-47.23||||||95.0||||||||||||
70883479|NCT00116831|141251008|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-16.9||||||95.0||||||||||||
70883480|NCT00116831|141251010|SUPERIORITY_OR_OTHER||Ratio to GLP as % difference from GLP|30.591||||||95.0||||||||||||
70883481|NCT00116831|141251011|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|7.642||||||95.0||||||||||||
70883482|NCT00116831|141251012|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|7.316||||||95.0||||||||||||
70883483|NCT00116831|141251013|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|15.731||||||95.0||||||||||||
70883484|NCT00116831|141251014|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|3.998||||||95.0||||||||||||
70883485|NCT00116831|141251015|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|11.728||||||95.0||||||||||||
70883486|NCT00116831|141251016|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-6.768||||||95.0||||||||||||
70883487|NCT00116831|141251017|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-14.478||||||95.0||||||||||||
70883488|NCT00116831|141251018|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-0.462||||||95.0||||||||||||
70883489|NCT00116831|141251019|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|0.0164||||||95.0||||||||||||
70883490|NCT00116831|141251020|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|0.118||||||95.0||||||||||||
70883491|NCT00116831|141251021|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|0.14||||||95.0||||||||||||
70883492|NCT01933048|141251025|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority||||||0.43|||||||Farrington-Manning Method|based on margin of 0.05||A/H1N1||||0.43
70883493|NCT01933048|141251025|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority||||||0.8|||||||Farrington-Manning Method|based on margin of 0.05||A/H3N2||||0.80
70883494|NCT01933048|141251025|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority||||||0.55|||||||Farrington-Manning Method|based on margin of 0.05||B/Yamagata||||0.55
70883495|NCT01933048|141251025|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority||||||0.16|||||||Farrington-Manning Method|based on margin of 0.05||B/Brisbane||||0.16
70883496|NCT00110812|141251030|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|134.0|||<|0.001|TWO_SIDED|95.0|70.0|198.0||Adjusted for 3 pairwise comparisons.|ANOVA|stratified by geographic region and adjusted for baseline CD4.||||198|70|<.001
70883497|NCT00110812|141251030|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|133.0|||<|0.001|TWO_SIDED|95.0|68.0|199.0||Adjusted for 3 pairwise comparisons.|ANOVA|stratified by geographic region and adjusted for baseline CD4.||||199|68|<.001
70883498|NCT00110812|141251032|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.31||||0.01|TWO_SIDED|95.0|0.08|0.54|||ANOVA|stratified by region and adjusted for baseline HIV-RNA.||||.54|.08|.01
70883499|NCT00110812|141251032|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.36||||0.003|TWO_SIDED|95.0|0.12|0.6|||ANOVA|stratified by region and adjusted for baseline HIV-RNA.||||.60|.12|.003
70883500|NCT00110812|141251033|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|65.8||||0.009||95.0|||||ANOVA|ANOVA with stratification by region and adjustment for baseline CD4||||||.009
70883501|NCT00110812|141251033|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|58.2||||0.02||95.0|||||ANOVA|stratified by region and adjusted for baseline CD4||||||.02
70883502|NCT00110812|141251036|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|5.08||||0.14|TWO_SIDED|95.0|0.59|43.6|||Regression, Cox|Unadjusted, stratified by region.|Patients taking IL-2 alone compared to patients not taking IL-2.|||43.6|0.59|.14
70963310|NCT02464228|141431265|OTHER|||||||0|||||||Wilson approximation|||Null hypothesis H0: PORR = 10% versus HA: PORR \> 10% will be tested at a = 0.05 significance level using a two-sided binomial test. The choice of test statistics was driven by the method used for interval estimation.||||0.000
70883503|NCT00110812|141251036|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|6.56||||0.08|TWO_SIDED|95.0|0.8|53.6|||Regression, Cox|Unadjusted, stratified by region.|Patients taking IL-2 plus pericycle HAART compared to patients not receiving IL-2|||53.6|0.80|.08
70883504|NCT00110812|141251037|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.58||||0.048|TWO_SIDED|95.0|0.34|0.99|||Regression, Cox||IL-2 without ART vs control group|||.99|.34|.048
70883505|NCT00110812|141251037|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.32|||<|0.001|TWO_SIDED|95.0|0.17|0.62|||Regression, Cox||IL-2 with pericycle HAART compared to control|||.62|.17|<.001
70883506|NCT00110812|141251038|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.34||||0.03|TWO_SIDED|95.0|0.03|0.64|||ANOVA|Stratified by region and adjusted for baseline HIV-RNA||||0.64|0.03|.03
70883507|NCT00110812|141251038|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.54|||<|0.001|TWO_SIDED|95.0|0.24|0.85|||ANOVA|Stratified by region and adjusted for baseline HIV-RNA||||0.85|0.24|<.001
70883508|NCT00110812|141251041|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.45||||0.59|TWO_SIDED|95.0|0.38|5.45|||Regression, Cox|Stratification by region.|IL-2 group compared to control group|||5.45|0.38|.59
70883509|NCT00110812|141251042|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-55.9|STANDARD_ERROR_OF_MEAN|28.4||0.05||95.0|||||ANOVA|Last measured CD4 is imputed if month 24 CD4 count is missing. Analysis is adjusted for baseline CD4.|IL-2 group minus control group CD4.|||||.05
70883510|NCT00110812|141251044|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.03|TWO_SIDED|95.0|0.52|0.97|||Regression, Cox||IL-2 groups vs. control|||.97|.52|.03
70883511|NCT00380393|141251045|OTHER||Vaccine Efficacy|52.9|||<|0.001|TWO_SIDED|95.0|28.1|69.1|||Regression, Cox||Point estimate of VE was adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum||69.1|28.1|<0.001
70883512|NCT00380393|141251045|OTHER||Vaccine Efficacy|55.0|||<|0.001|TWO_SIDED|95.0|31.4|70.4|||Regression, Cox||Point estimate of VE was not adjusted for site, age, bednet use, area or distance from health center.|Vaccine efficacy against P. falciparum||70.4|31.4|<0.001
70883513|NCT00380393|141251046|OTHER||Vaccine efficacy|54.6|||<|0.001|TWO_SIDED|95.0|31.2|70.0|||Regression, Cox||Point estimate of VE was adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum.||70.0|31.2|<0.001
70883514|NCT00380393|141251046|OTHER||Vaccine efficacy|56.5|||<|0.001|TWO_SIDED|95.0|34.2|71.2|||Regression, Cox||Point estimate of VE was not adjusted for site, age, bednet use, area or distance from health center.|Vaccine efficacy against P. falciparum.||71.2|34.2|<0.001
70883515|NCT00380393|141251047|OTHER||Vaccine efficacy|55.8||||0.0003|TWO_SIDED|95.0|31.0|71.7|||Regression, Cox||Point estimate of VE was adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum.||71.7|31.0|0.0003
70883516|NCT00380393|141251047|OTHER||Vaccine efficacy|57.9|||<|0.001|TWO_SIDED|95.0|34.3|73.0|||Regression, Cox||Point estimate of VE was not adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum.||73.0|34.3|<0.001
70883517|NCT00380393|141251048|OTHER||Vaccine efficacy|58.0|||<|0.001|TWO_SIDED|95.0|34.8|73.0|||Regression, Cox||Point estimate of VE was adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum.||73.0|34.8|<0.001
70883518|NCT00380393|141251048|OTHER||Vaccine efficacy|59.5|||<|0.001|TWO_SIDED|95.0|37.1|73.9|||Regression, Cox||Point estimate of VE was not adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum.||73.9|37.1|<0.001
70883519|NCT01921829|141251109|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
70883520|NCT01921829|141251110|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||||||0.29
70883521|NCT01921829|141251112|SUPERIORITY||||||>|0.95|||||||Fisher Exact|||||||>0.95
70883522|NCT01921829|141251113|SUPERIORITY|||||||0.58|||||||Fisher Exact|||||||0.58
70883523|NCT01921829|141251114|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|||||||0.86
70883524|NCT01921829|141251115|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||0.40
70883525|NCT01921829|141251116|SUPERIORITY||||||>|0.95|||||||Fisher Exact|||||||>0.95
70883526|NCT01921829|141251117|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
70883527|NCT01921829|141251118|SUPERIORITY||||||>|0.95|||||||t-test, 2 sided|||||||>0.95
70883528|NCT01921829|141251119|SUPERIORITY|||||||0.52|||||||t-test, 2 sided|||||||0.52
70883529|NCT01921829|141251120|SUPERIORITY||||||>|0.95|||||||t-test, 2 sided|||||||>0.95
70883530|NCT01921829|141251121|SUPERIORITY||||||>|0.95|||||||t-test, 2 sided|||||||>0.95
70963311|NCT02464228|141431265|OTHER|||||||1|||||||Wilson approximation|||Null hypothesis H0: PORR = 10% versus HA: PORR \> 10% will be tested at a = 0.05 significance level using a two-sided binomial test. The choice of test statistics was driven by the method used for interval estimation.||||1.000
70883531|NCT01921829|141251122|SUPERIORITY|||||||0.52|||||||t-test, 2 sided|||||||0.52
70883532|NCT01921829|141251123|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
70883533|NCT01921829|141251124|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
70883534|NCT01921829|141251125|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||0.40
70883535|NCT01921829|141251126|SUPERIORITY||||||>|0.95|||||||t-test, 2 sided|||||||>0.95
70883536|NCT01921829|141251127|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
70883537|NCT01921829|141251128|SUPERIORITY||||||>|0.95|||||||t-test, 2 sided|||||||>0.95
70883538|NCT01921829|141251129|SUPERIORITY||||||>|0.95|||||||Fisher Exact|||||||>0.95
70883539|NCT04476030|141251130|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.55||0.0004|TWO_SIDED|95.0|-3.0|-0.9|||MMRM||Model used was the MMRM with treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||-0.9|-3.0|0.0004
70883540|NCT04476030|141251131|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.56||0.0054|TWO_SIDED|95.0|-2.7|-0.5|||MMRM||Model used was the MMRM with treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||-0.5|-2.7|0.0054
70883541|NCT04476030|141251132|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.7||0.2477|TWO_SIDED|95.0|-2.2|0.6|||MMRM||Model used was the MMRM with treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|Day 15||0.6|-2.2|0.2477
70883542|NCT04476030|141251132|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.79||0.9248|TWO_SIDED|95.0|-1.6|1.5|||MMRM||Model used was the MMRM with treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|Day 42||1.5|-1.6|0.9248
70883543|NCT04476030|141251133|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.65||0.4458|TWO_SIDED|95.0|-1.8|0.8|||MMRM||Model used was the MMRM with treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||0.8|-1.8|0.4458
70883544|NCT04476030|141251134|SUPERIORITY||Odds Ratio (OR)|1.15||||0.4946|TWO_SIDED|95.0|0.78|1.69|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|Day 15|Generalized estimating equation is abbreviated as GEE in the method of estimation section.|1.69|0.78|0.4946
70883545|NCT04476030|141251134|SUPERIORITY||Odds Ratio (OR)|0.82||||0.3579|TWO_SIDED|95.0|0.55|1.24|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|Day 42||1.24|0.55|0.3579
70883546|NCT04476030|141251135|SUPERIORITY||Odds Ratio (OR)|1.41||||0.1417|TWO_SIDED|95.0|0.89|2.24|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|Day 15||2.24|0.89|0.1417
70883547|NCT04476030|141251135|SUPERIORITY||Odds Ratio (OR)|0.94||||0.7872|TWO_SIDED|95.0|0.62|1.44|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|Day 42||1.44|0.62|0.7872
70883548|NCT04476030|141251136|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1993|TWO_SIDED|95.0|-0.4|0.1|||MMRM||Model used was the MMRM with treatment, baseline CGI-S score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||0.1|-0.4|0.1993
70883549|NCT04476030|141251137|SUPERIORITY||Odds Ratio (OR)|2.05||||0.0079|TWO_SIDED|95.0|1.21|3.47|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline CGI-S score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|Day 3||3.47|1.21|0.0079
70883550|NCT04476030|141251137|SUPERIORITY||Odds Ratio (OR)|1.09||||0.6588|TWO_SIDED|95.0|0.74|1.62|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline CGI-S score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|Day 15||1.62|0.74|0.6588
70883551|NCT04476030|141251138|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|1.06||0.2322|TWO_SIDED|95.0|-3.4|0.8|||MMRM||Model used was the MMRM with treatment, baseline MADRS total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||0.8|-3.4|0.2322
70883552|NCT04476030|141251139|SUPERIORITY||Odds Ratio (OR)|1.13||||0.5439|TWO_SIDED|95.0|0.76|1.68|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline MADRS total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|||1.68|0.76|0.5439
70883553|NCT04476030|141251140|SUPERIORITY||Odds Ratio (OR)|1.09||||0.7054|TWO_SIDED|95.0|0.7|1.69|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline MADRS total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|||1.69|0.70|0.7054
70883554|NCT04476030|141251141|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.62||0.4188|TWO_SIDED|95.0|-1.7|0.7|||MMRM||Model used was the MMRM with treatment, baseline HAM-A total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||0.7|-1.7|0.4188
70883555|NCT04476030|141251143|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.62||0.7758|TWO_SIDED|95.0|-1.4|1.0|||MMRM||Model used was the MMRM with treatment, baseline PHQ-9 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||1.0|-1.4|0.7758
70883556|NCT02404311|141251175|OTHER||Proportion Difference (Net)|-0.015||||1|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to 1086C\_D7gp120.avi/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||1.0000
70883557|NCT02404311|141251175|OTHER||Proportion Difference (Net)|-0.015||||1|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to 96ZM651.D11gp120.avi after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||1.0000
70883558|NCT02404311|141251175|OTHER||Proportion Difference (Net)|-0.015||||1|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to TV1c8\_D11gp120.avi/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||1.0000
70883559|NCT02404311|141251176|OTHER||Geometric Mean difference (Net)|0.914|||<|0.0001|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to 1086C\_D7gp120.avi/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||<.0001
70883560|NCT02404311|141251176|OTHER||Geometric Mean difference (Net)|0.945|||<|0.0001|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to 96ZM651.D11gp120.avi after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||<.0001
70883561|NCT02404311|141251176|OTHER||Geometric Mean difference (Net)|0.895|||<|0.0001|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to TV1c8\_D11gp120.avi/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||<.0001
70883562|NCT02404311|141251177|OTHER||Proportion Difference (Net)|0.0||||0.0215|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to C.1086C\_V1\_V2 Tags after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.0215
70883563|NCT02404311|141251177|OTHER||Proportion Difference (Net)|0.0||||0.0003|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to gp70-96ZM651.02 V1v2 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.0003
70963312|NCT02464228|141431265|OTHER|||||||0.026|||||||Wilson approximation|||Null hypothesis H0: PORR = 10% versus HA: PORR \> 10% will be tested at a = 0.05 significance level using a two-sided binomial test. The choice of test statistics was driven by the method used for interval estimation.||||0.026
70883564|NCT02404311|141251177|OTHER||Proportion Difference (Net)|0.228||||0.001|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to gp70-TV1.GSKvacV1V2/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.0010
70883565|NCT02404311|141251178|OTHER||Geometric Mean difference (Net)|0.0|||<|0.0001|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to C.1086C\_V1\_V2 Tags after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||<.0001
70883566|NCT02404311|141251178|OTHER||Geometric Mean difference (Net)|0.0|||<|0.0001|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to gp70-96ZM651.02 V1v2 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||<.0001
70883567|NCT02404311|141251178|OTHER||Geometric Mean difference (Net)|6.099||||0.0002|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to gp70-TV1.GSKvacV1V2/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.0002
70883568|NCT02404311|141251179|OTHER||Proportion Difference (Net)|0.018||||1|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|CD4+ T Cell Responses to 1086 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||1.0000
70883569|NCT02404311|141251179|OTHER||Proportion Difference (Net)|0.036||||0.6698|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|CD4+ T Cell Responses to TV1 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.6698
70883570|NCT02404311|141251179|OTHER||Proportion Difference (Net)|0.125||||0.1435|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|CD4+ T Cell Responses to ZM96 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.1435
70883571|NCT02404311|141251180|OTHER||Geometric Mean difference (Net)|0.965||||0.9661|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|CD4+ T Cell Responses to 1086 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.9661
70883572|NCT02404311|141251180|OTHER||Geometric Mean difference (Net)|1.118||||0.8593|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|CD4+ T Cell Responses to TV1 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.8593
70883573|NCT02404311|141251180|OTHER||Geometric Mean difference (Net)|1.138||||0.4396|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|CD4+ T Cell Responses to ZM96 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.4396
70883574|NCT01536496|141251190|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Chi-squared|||Chi-square test||||0.04
70883575|NCT01344447|141251215|SUPERIORITY_OR_OTHER||Percentage difference|22.3|||<|0.0001|TWO_SIDED|95.1|20.4||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Majority reader; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||20.4|<0.0001
70883576|NCT01344447|141251215|SUPERIORITY_OR_OTHER||Percentage difference|63.8|||<|0.0001|TWO_SIDED|95.1|60.9||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Blinded reader 1; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||60.9|<0.0001
70883577|NCT01344447|141251215|SUPERIORITY_OR_OTHER||Percentage difference|19.6|||<|0.0001|TWO_SIDED|95.1|17.8||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Blinded reader 2; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||17.8|<0.0001
70883578|NCT01344447|141251215|SUPERIORITY_OR_OTHER||Percentage difference|15.0|||<|0.0001|TWO_SIDED|95.1|13.3||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Blinded reader 3; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||13.3|<0.0001
70883579|NCT01344447|141251215|SUPERIORITY_OR_OTHER||Percentage difference|18.5|||<|0.0001|TWO_SIDED|95.1|16.5||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Clinical investigator; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||16.5|<0.0001
70883580|NCT01344447|141251216|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|5.7|||||TWO_SIDED|95.1|-3.6||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Majority reader; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-3.6|
70883581|NCT01344447|141251216|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|5.1|||||TWO_SIDED|95.1|-5.4||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 1; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-5.4|
70883582|NCT01344447|141251216|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|5.1|||||TWO_SIDED|95.1|-4.7||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 2; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-4.7|
70883583|NCT01344447|141251216|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|3.2|||||TWO_SIDED|95.1|-5.9||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 3; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-5.9|
70883584|NCT01344447|141251216|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|21.5|||||TWO_SIDED|95.1|14.1||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Clinical investigator; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||14.1|
70883585|NCT01344447|141251217|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|8.8|||||TWO_SIDED|95.1|7.7||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Majority reader; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||7.7|
70883586|NCT01344447|141251217|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|30.3|||||TWO_SIDED|95.1|28.6||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 1; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||28.6|
70883587|NCT01344447|141251217|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|9.7|||||TWO_SIDED|95.1|8.5||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 2; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||8.5|
70883588|NCT01344447|141251217|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|7.6|||||TWO_SIDED|95.1|6.6||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 3; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||6.6|
70883589|NCT01344447|141251217|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|9.1|||||TWO_SIDED|95.1|7.9||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Clinical investigator; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||7.9|
70883590|NCT01344447|141251218|SUPERIORITY_OR_OTHER||percentage|61.7|||||ONE_SIDED|95.1|55.3||||One sided 95.1% confidence interval|||Majority reader|||55.3|
70883591|NCT01344447|141251218|SUPERIORITY_OR_OTHER||percentage|60.3|||||ONE_SIDED|95.1|53.6||||One sided 95.1% confidence interval|||Blinded Reader 1|||53.6|
70883592|NCT01344447|141251218|SUPERIORITY_OR_OTHER||percentage|59.6|||||ONE_SIDED|95.1|53.1||||One sided 95.1% confidence interval|||Blinded Reader 2|||53.1|
70883593|NCT01344447|141251218|SUPERIORITY_OR_OTHER||percentage|58.7|||||ONE_SIDED|95.1|52.2||||One sided 95.1% confidence interval|||Blinded Reader 3|||52.2|
70883594|NCT01344447|141251218|SUPERIORITY_OR_OTHER||percentage|61.5|||||ONE_SIDED|95.1|56.7||||One sided 95.1% confidence interval|||Clinical investigator|||56.7|
70883595|NCT01344447|141251219|SUPERIORITY_OR_OTHER||percentage|98.0|||||ONE_SIDED|95.1|97.7||||One sided 95.1% confidence interval|||Majority reader|||97.7|
70883596|NCT01344447|141251219|SUPERIORITY_OR_OTHER||percentage|97.6|||||ONE_SIDED|95.1|97.3||||One sided 95.1% confidence interval|||Blinded Reader 1|||97.3|
70883597|NCT01344447|141251219|SUPERIORITY_OR_OTHER||percentage|97.2|||||ONE_SIDED|95.1|96.9||||One sided 95.1% confidence interval|||Blinded Reader 2|||96.9|
70883598|NCT01344447|141251219|SUPERIORITY_OR_OTHER||percentage|98.0|||||ONE_SIDED|95.1|97.7||||One sided 95.1% confidence interval|||Blinded Reader 3|||97.7|
70883599|NCT01344447|141251219|SUPERIORITY_OR_OTHER||percentage|99.2|||||ONE_SIDED|95.1|98.9||||One sided 95.1% confidence interval|||Clinical investigator|||98.9|
70883600|NCT01344447|141251220|SUPERIORITY_OR_OTHER||Diameter difference|0.21|STANDARD_DEVIATION|0.8|||||||||Mean Difference|||CTA Minus Unenhanced MRA for blinded Reader on vessel DIA at normal point||||
70883601|NCT01344447|141251220|SUPERIORITY_OR_OTHER||Diameter difference|0.0|STANDARD_DEVIATION|0.79|||||||||Mean Difference|||CTA minus Gadobutrol-Enhanced MRA for blinded reader on vessel DIA at normal point||||
70883602|NCT01344447|141251220|SUPERIORITY_OR_OTHER||Diameter difference|0.29|STANDARD_DEVIATION|0.87|||||||||Mean Difference|||CTA minus Unenhanced MRA for blinded reader on vessel DIA at narrowest point||||
70883603|NCT01344447|141251220|SUPERIORITY_OR_OTHER||Diameter difference|0.01|STANDARD_DEVIATION|0.8|||||||||Mean Difference|||CTA minus Gadobutrol-Enhanced MRA for blinded reader on vessel DIA at narrowest point||||
70883604|NCT01344447|141251220|SUPERIORITY_OR_OTHER||Diameter difference|0.48|STANDARD_DEVIATION|0.98|||||||||Mean Difference|||CTA minus Unenhanced MRA for clinical investigators on vessel DIA at normal point||||
70883605|NCT01344447|141251220|SUPERIORITY_OR_OTHER||Diameter difference|0.33|STANDARD_DEVIATION|1.01|||||||||Mean Difference|||CTA minus Gadobutrol-enhanced MRA for clinical investigators on vessel DIA at normal point||||
70883606|NCT01344447|141251220|SUPERIORITY_OR_OTHER||Diameter difference|0.02|STANDARD_DEVIATION|0.81|||||||||Mean Difference|||CTA minus Unenhanced MRA for clinical investigators on vessel DIA at narrowest point||||
70883607|NCT01344447|141251220|SUPERIORITY_OR_OTHER||Diameter difference|0.11|STANDARD_DEVIATION|0.79|||||||||Mean Difference|||CTA minus Gadobutrol-enhanced MRA for clinical investigators on vessel DIA at narrowest point||||
70883608|NCT00218296|141251235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.51||||0.04|TWO_SIDED|95.0|0.26|0.99|||Chi-squared|There were no adjustments in the analysis.|The reference group for the odds ratio estimate is the usual care condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.||0.99|0.26|0.04
70883609|NCT00218296|141251236|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.28||||0.019|TWO_SIDED|95.0|0.07|0.83|||Chi-squared|There were no adjustments in the analysis.|The reference group for the odds ratio estimate is the Usual Care condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.||0.83|0.07|0.019
70883610|NCT00218296|141251237|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42||||0.03|TWO_SIDED|95.0|0.18|0.94|||Chi-squared|There were no adjustments in the analysis.|The reference group for the odds ratio estimate is the usual care condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.||0.94|0.18|0.03
70883611|NCT00218296|141251238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.09||||0.002|TWO_SIDED|95.0|0.004|0.48|||Chi-squared|There were no adjustments in the analysis.|The reference group for the odds ratio estimate is the Usual Care Condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.||0.48|0.004|.002
70883612|NCT00218296|141251239|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.056|TWO_SIDED|95.0|0.2|1.03|||Chi-squared|There were no adjustments in the analysis.|The reference group for the odds ratio estimate is the Usual Care Condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.||1.03|0.20|0.056
70883613|NCT00218296|141251240|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.09||||0.002|TWO_SIDED|95.0|0.004|0.48||There were no adjustments in the analysis.|Chi-squared||The reference group for the odds ratio estimate is the Usual Care Condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.||0.48|0.004|0.002
70883614|NCT01067768|141251241|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.5|1.3|||||The primary outcome analysis was performed using relative risk (RR) between the rate of urinary tract infection per 1,000 days of exposure of the test subjects to intervention and that of patients undergoing routine care.|The sample size was calculated for the primary outcome. An infection rate 15 per 1,000 urinary catheter days in the control group and an expected reduction in the intervention group 40% clinically important effect. Mapping one to one, 5% alpha error and beta error 20%.||1.3|0.50|
70883615|NCT01067768|141251242|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||The difference between groups was evaluated with a U test Mann Whitney. The difference was statistically significant with p values less than 0.05|Wilcoxon (Mann-Whitney)|||Null hypothesis: On average catheterization are the same in patients with daily review of the indication and control group patients||||0.016
70883616|NCT01094548|141251268|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0000
70883617|NCT01094548|141251272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.431||||0.094|TWO_SIDED|95.0|0.157|1.185|||Log Rank|||||1.185|0.157|0.0940
70883618|NCT01094548|141251273|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.666||||0.3919|TWO_SIDED|95.0|0.261|1.698|||Log Rank|||||1.698|0.261|0.3919
70883619|NCT00746941|141251333|SUPERIORITY_OR_OTHER|||||||0.7132|||||||Student's t-test|||||||0.7132
70883620|NCT00746941|141251334|SUPERIORITY_OR_OTHER|||||||0.9086|||||||Student's t-test|||||||0.9086
70883621|NCT02180412|141251349|OTHER||Slope|7.76||||0.0434|TWO_SIDED|95.0|2.14|13.37|||ANCOVA|||ALA Day 1 vs Day 2||13.37|2.14|.0434
70883622|NCT02180412|141251349|OTHER||Slope|16.29||||0.0003|TWO_SIDED|95.0|11.32|21.25|||ANCOVA|||ALA Day 1 vs Day 3||21.25|11.32|.0003
70883623|NCT02180412|141251349|OTHER||Slope|15.98||||0.0198|TWO_SIDED|95.0|6.7|25.26|||ANCOVA|||ALA Day 1 vs Day 4||25.26|6.7|.0198
70883624|NCT02180412|141251349|OTHER||Slope|10.69||||0.158|TWO_SIDED|95.0|-1.67|22.49|||ANCOVA|||PBG Day 1 vs Day 2||22.49|-1.67|.158
70883625|NCT02180412|141251349|OTHER||Slope|24.52||||0.0127|TWO_SIDED|95.0|11.3|37.74|||ANCOVA|||PGB Day 1 vs Day 3||37.74|11.3|.0127
70883626|NCT02180412|141251349|OTHER||Slope|28.45||||0.0328|TWO_SIDED|95.0|9.64|47.27|||ANCOVA|||PBG Day 1 vs Day 4||47.27|9.64|.0328
70883627|NCT02180412|141251349|OTHER||Slope|12.2||||0.9993|TWO_SIDED|95.0|-465.4|489.8|||ANCOVA|||Total Porphyrins Day 1 vs Day 2||489.8|-465.4|.9993
70963313|NCT02464228|141431265|OTHER|||||||1|||||||Clopper-Pearson method|||Null hypothesis H0: PORR = 10% versus HA: PORR \> 10% will be tested at a = 0.05 significance level using a two-sided binomial test. The choice of test statistics was driven by the method used for interval estimation.||||1.000
70883628|NCT02180412|141251349|OTHER||Slope|454.5||||0.2915|TWO_SIDED|95.0|-200.87|1109.86|||ANCOVA|||Total Porphyrins Day 1 vs Day 3||1109.86|-200.87|.2915
70883629|NCT02180412|141251349|OTHER||Slope|326.12||||0.4382|TWO_SIDED|95.0|-292.0|944.25|||ANCOVA|||Total Porphyrins Day 1 vs Day 4||944.25|-292|.4382
70883630|NCT04654117|141251353|SUPERIORITY|Multilevel model predicting the effect of the overall consultation model on manual adherence, averaged across clinicians.|unstandardized beta|0.33|STANDARD_ERROR_OF_MEAN|3.85|<|0.05|TWO_SIDED||||||multilevel model|||||||<.05
70883631|NCT04654117|141251354|SUPERIORITY||unstandardized beta|0.04|STANDARD_ERROR_OF_MEAN|0.08|<|0.05|TWO_SIDED||||||multilevel model|||||||<.05
70883632|NCT04654117|141251355|OTHER|multilevel modeling|multilevel modeling|2.56|STANDARD_ERROR_OF_MEAN|0.74|<|0.05|TWO_SIDED||||||multilevel modeling|||||||<.05
70883633|NCT04654117|141251356|SUPERIORITY||ANOVA|17.0|||<|0.05|TWO_SIDED||||||ANOVA|||||||<.05
70883634|NCT04654117|141251357|OTHER|multilevel model|multilevel model|0.04|STANDARD_ERROR_OF_MEAN|0.02|<|0.05|TWO_SIDED||||||multilevel model|||||||<.05
70883635|NCT04654117|141251358|OTHER|multilevel model|multilevel model (beta)|-0.27|STANDARD_ERROR_OF_MEAN|0.15|<|0.05|TWO_SIDED||||||multilevel model|||||||<.05
70883636|NCT00405548|141251362|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
70883637|NCT00405548|141251363|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
70883638|NCT00405548|141251364|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
70883639|NCT00405548|141251365|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|A p-value of less 0.05 was considered to be statistically significant.||Mean LV filling pressure was compared from baseline to 12 weeks within the BNP group.||||0.004
70883640|NCT00405548|141251365|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||t-test, 2 sided|A p-value of less 0.05 was considered to be statistically significant.||Mean LV filling pressure was compared from baseline to 12 weeks within the Placebo group.||||0.43
70883641|NCT00923559|141251370|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.69|STANDARD_ERROR_OF_MEAN|3.04||0.006||95.0|2.64|14.74||Null hypothesis MIP and CHC care should yield equal outcomes. A priori threshold p\<.05.|Regression, Linear|Degrees of freedom (df) = 68.3||Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.||14.74|2.64|.006
70883642|NCT00923559|141251371|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.57|STANDARD_ERROR_OF_MEAN|1.06||0.018|TWO_SIDED|95.0|0.46|4.68||p-value unadjusted for multiple comparisons. A priori threshold p\<.05.|Regression, Linear|Degrees of freedom (df) = 69.3||Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.||4.68|0.46|.018
70883643|NCT00923559|141251372|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.27|STANDARD_ERROR_OF_MEAN|0.24||0.266|TWO_SIDED|95.0|-0.21|0.75||p-value unadjusted for multiple comparisons. A priori threshold p\<.05.|Regression, Linear|Degrees of freedom = 73.4||Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.||0.75|-0.21|.266
70883644|NCT00923559|141251373|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.08||0.052|TWO_SIDED|95.0|0.0|0.32||p-value unadjusted for multiple comparisons. A priori threshold p\<.05.|Regression, Linear|||Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.||0.32|0.00|.052
70883645|NCT00923559|141251374|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.84|STANDARD_ERROR_OF_MEAN|0.38||0.031|TWO_SIDED|95.0|-1.61|-0.08|||Regression, Linear|Degrees of freedom (df) = 61.2||see under the PIR-GAS||-0.08|-1.61|.031
70883646|NCT00923559|141251375|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.09||0.158|TWO_SIDED|95.0|-0.05|0.31|||Mixed Models Analysis|Degrees of freedom (df) = 71.2||Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.||0.31|-0.05|.158
70963314|NCT00148954|141431291|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.34||||0.003|TWO_SIDED|95.0|1.11|1.62|||Regression, Cox|||||1.62|1.11|0.003
70883647|NCT00811577|141251376|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED|95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using serial gate-keeping to preserve the 5% overall type I error of 1-4 two-sided tests, 2-sided Wilcoxon Signed Rank tests were used. Computer graphics were used to display outcomes at Month 12, compare paired differences of outcomes between the 2 dosages and placebo, and show time trends in mean outcomes. Repeated measures regression models (GEE models in SAS/STAT PROC GENMOD) were used to examine longitudinal outcomes with terms for treatment and trocar location adjusted for key covariates.||||0.57
70883648|NCT00811577|141251376|SUPERIORITY_OR_OTHER|||||||0.56||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using serial gate-keeping to preserve the 5% overall type I error of 1-4 two-sided tests, 2-sided Wilcoxon Signed Rank tests were used. Computer graphics were used to display outcomes at Month 12, compare paired differences of outcomes between the 2 dosages and placebo, and show time trends in mean outcomes. Repeated measures regression models (GEE models in SAS/STAT PROC GENMOD) were used to examine longitudinal outcomes with terms for treatment and trocar location adjusted for key covariates.||||0.56
70883649|NCT00811577|141251376|SUPERIORITY_OR_OTHER|||||||0.61||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using serial gate-keeping to preserve the 5% overall type I error of 1-4 two-sided tests, 2-sided Wilcoxon Signed Rank tests were used. Computer graphics were used to display outcomes at Month 12, compare paired differences of outcomes between the 2 dosages and placebo, and show time trends in mean outcomes. Repeated measures regression models (GEE models in SAS/STAT PROC GENMOD) were used to examine longitudinal outcomes with terms for treatment and trocar location adjusted for key covariates.||||0.61
70883650|NCT00811577|141251376|SUPERIORITY_OR_OTHER|||||||0.8||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using serial gate-keeping to preserve the 5% overall type I error of 1-4 two-sided tests, 2-sided Wilcoxon Signed Rank tests were used. Computer graphics were used to display outcomes at Month 12, compare paired differences of outcomes between the 2 dosages and placebo, and show time trends in mean outcomes. Repeated measures regression models (GEE models in SAS/STAT PROC GENMOD) were used to examine longitudinal outcomes with terms for treatment and trocar location adjusted for key covariates.||||0.80
70883651|NCT00811577|141251377|SUPERIORITY_OR_OTHER|||||||0.47||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using a 100 mm VAS scale, each photograph was assessed by two raters, who, in an end-of-study session, were presented with photographs in their longitudinal sequence, but blinded as to dosage group. These data were used for an inter-rater concordance analysis and also to compare the placebo, 3 and 10 mg dosages.||||0.47
70883652|NCT00811577|141251377|SUPERIORITY_OR_OTHER|||||||0.08||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using a 100 mm VAS scale, each photograph was assessed by two raters, who, in an end-of-study session, were presented with photographs in their longitudinal sequence, but blinded as to dosage group. These data were used for an inter-rater concordance analysis and also to compare the placebo, 3 and 10 mg dosages.||||0.080
70883653|NCT00811577|141251377|SUPERIORITY_OR_OTHER|||||||0.96||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using a 100 mm VAS scale, each photograph was assessed by two raters, who, in an end-of-study session, were presented with photographs in their longitudinal sequence, but blinded as to dosage group. These data were used for an inter-rater concordance analysis and also to compare the placebo, 3 and 10 mg dosages.||||0.96
70883654|NCT00811577|141251377|SUPERIORITY_OR_OTHER|||||||0.22||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using a 100 mm VAS scale, each photograph was assessed by two raters, who, in an end-of-study session, were presented with photographs in their longitudinal sequence, but blinded as to dosage group. These data were used for an inter-rater concordance analysis and also to compare the placebo, 3 and 10 mg dosages.||||0.22
70963315|NCT01387230|141431375|SUPERIORITY_OR_OTHER||Least squares mean difference|0.127|||<|0.001|TWO_SIDED|95.0|0.052|0.202|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|Least squares mean difference=UMEC 62.5 µg minus Placebo.|||0.202|0.052|<0.001
70883655|NCT00811577|141251378|SUPERIORITY_OR_OTHER|||||||0.87||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.87
70883656|NCT00811577|141251378|SUPERIORITY_OR_OTHER|||||||0.15||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.15
70883657|NCT00811577|141251378|SUPERIORITY_OR_OTHER|||||||0.77||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.77
70963316|NCT01387230|141431375|SUPERIORITY_OR_OTHER||Least squares mean difference|0.152|||<|0.001|TWO_SIDED|95.0|0.076|0.229|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|Least squares mean difference=UMEC 125 µg minus Placebo.|||0.229|0.076|<0.001
70963317|NCT04561765|141431384|SUPERIORITY|||||||0.051|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P values at discharge||||0.051
70963318|NCT04561765|141431384|SUPERIORITY|||||||0.206|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P values at discharge.||||0.206
70883658|NCT00811577|141251378|SUPERIORITY_OR_OTHER|||||||0.75||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.75
70883659|NCT00811577|141251378|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.050
70883660|NCT00811577|141251378|SUPERIORITY_OR_OTHER|||||||0.83||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.83
70883661|NCT00811577|141251378|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.37
70883662|NCT00811577|141251378|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.43
70883663|NCT00811577|141251379|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.16
70883664|NCT00811577|141251379|SUPERIORITY_OR_OTHER|||||||0.14||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.14
70883665|NCT00811577|141251379|SUPERIORITY_OR_OTHER|||||||0.69||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.69
70883666|NCT00811577|141251379|SUPERIORITY_OR_OTHER|||||||0.89||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.89
70883667|NCT00811577|141251379|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.30
70883668|NCT00811577|141251379|SUPERIORITY_OR_OTHER|||||||0.46||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.46
70883669|NCT00811577|141251380|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.||||0.086
70883670|NCT00811577|141251380|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.||||0.66
70883671|NCT00811577|141251380|SUPERIORITY_OR_OTHER|||||||0.069||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.||||0.069
70963319|NCT04561765|141431384|SUPERIORITY|||||||0.765|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P values at discharge||||0.765
70883672|NCT00811577|141251380|SUPERIORITY_OR_OTHER|||||||0.68||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.||||0.68
70883673|NCT00811577|141251380|SUPERIORITY_OR_OTHER|||||||0.095||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.||||0.095
70883674|NCT00811577|141251380|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.||||0.62
70883675|NCT00811577|141251381|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||Wilcoxon (signed rank)|||A regression analysis was run to compare alpha-SMA between 3 mg and 10 mg AZX100 and placebo, adjusted for the subject's gender and age. GEE regression in SAS/STAT PROC GENMOD was used because it properly handled the correlations among the three observations for each subject.||||0.44
70883676|NCT00811577|141251381|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||Wilcoxon (signed rank)|||A regression analysis was run to compare alpha-SMA between 3 mg and 10 mg AZX100 and placebo, adjusted for the subject's gender and age. GEE regression in SAS/STAT PROC GENMOD was used because it properly handled the correlations among the three observations for each subject.||||0.41
70883677|NCT02641379|141251384|SUPERIORITY_OR_OTHER|||||||0.1002|||||||Chi-squared|||For Genotype I, Week 4 response \< 600 U/ml: Comparison of Group A versus Group B was carried out using the Chi-Square test.||||0.1002
70883678|NCT02641379|141251384|SUPERIORITY_OR_OTHER|||||||0.0184|||||||Chi-squared|||For Genotype I, Week 4 response \>= 600 U/ml: Comparison of Group A versus Group B was carried out using the Chi-Square test.||||0.0184
70883679|NCT02641379|141251384|SUPERIORITY_OR_OTHER|||||||0.091|||||||Chi-squared|||For Genotype IV, Week 4 response \< 600 U/ml: Comparison of Group A versus Group B was carried out using the Chi-Square test.||||0.0910
70883680|NCT02641379|141251384|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||For Genotype IV, Week 4 response \>= 600 U/ml: Comparison of Group A versus Group B was carried out using the Chi-Square test.||||1.0000
70883681|NCT02641379|141251385|SUPERIORITY_OR_OTHER|||||||0.0021||||||The SVR rate i.e., 32.1% participants with genotype I who achieved SVR with 95 % confidence interval of 20.3 to 46.0 in groups A1+B1 was compared with SVR rate in group E using Cochran-Mantel-Haenszel method .|Cochran-Mantel-Haenszel|||Comparison of Groups A1+B1 versus group E stratified by genotype I.||||0.0021
70883682|NCT02641379|141251385|SUPERIORITY_OR_OTHER|||||||0.3031||||||The SVR rate i.e., 20.0% participants with genotype IV who achieved SVR with 95 % confidence interval of 0.5 to 71.6 in groups A1+B1 was compared with SVR rate in group E using Cochran-Mantel-Haenszel method .|Cochran-Mantel-Haenszel|||Comparison of Groups A1+B1 versus group E stratified by genotype IV||||0.3031
70883683|NCT01165138|141251399|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.136||||0.002|TWO_SIDED|95.0|0.051|0.222|||ANCOVA|||||0.222|0.051|0.002
70883684|NCT01165138|141251399|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.172|||<|0.001|TWO_SIDED|95.0|0.087|0.258|||ANCOVA|||||0.258|0.087|<0.001
70883685|NCT01165138|141251399|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.036||||0.405|TWO_SIDED|95.0|-0.048|0.12|||ANCOVA|||||0.120|-0.048|0.405
70883686|NCT01165138|141251400|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.186||||0.003|TWO_SIDED|95.0|0.062|0.31|||ANCOVA|||||0.310|0.062|0.003
70883687|NCT01165138|141251400|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.302|||<|0.001|TWO_SIDED|95.0|0.178|0.426|||ANCOVA|||||0.426|0.178|<0.001
70883688|NCT01165138|141251400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.116||||0.06|TWO_SIDED|95.0|-0.005|0.236|||ANCOVA|||||0.236|-0.005|0.060
70883689|NCT04982250|141251417|SUPERIORITY||Risk Difference (RD)|-6.0|||||TWO_SIDED|95.0|-26.0|11.0|||||Risk differences (RD) with 95% confidence intervals (CI) were estimated using regression models with Gaussian distributions, identify links, study group fixed effects, and index peer random effects (to adjust for clustering).|The sample size calculation was based on the primary PrEP initiation outcome at follow-up; 80 clusters (40 per study group) provided 80% power to detect a 17% difference in PrEP initiation between the enhanced (80%) and standard (63%) groups, assuming three referred peers per cluster (75% of those recommended), an intra-cluster correlation coefficient of 0.05, and an alpha level of 0.05.||11|-26|
70883690|NCT04982250|141251422|SUPERIORITY||Risk Difference (RD)|39.0|||||TWO_SIDED|95.0|24.0|54.0||||||||54|24|
70883691|NCT04982250|141251423|SUPERIORITY||Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-10.0|13.0||||||||13|-10|
70883692|NCT04982250|141251424|SUPERIORITY||Risk Difference (RD)|-19.0|||||TWO_SIDED|95.0|-40.0|2.0||||||||2|-40|
70963320|NCT04561765|141431384|SUPERIORITY|||||||0.991|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P values at follow-up.||||0.991
70883693|NCT04982250|141251425|SUPERIORITY||Median Difference (Final Values)|-16.9|||||TWO_SIDED|95.0|-36.3|2.5||||||||2.5|-36.3|
70883694|NCT04982250|141251426|SUPERIORITY||Median Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-0.2|1.1||||||||1.1|-0.2|
70883695|NCT01644175|141251442|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.9|||<|0.0001|TWO_SIDED|95.0|-52.5|-39.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-39.3|-52.5|<0.0001
70883696|NCT01644175|141251443|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.9|||<|0.0001|TWO_SIDED|95.0|-56.2|-43.6||Threshold for significance was ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-43.6|-56.2|<0.0001
70883697|NCT01644175|141251444|SUPERIORITY_OR_OTHER||LS Mean Difference|-47.4|||<|0.0001|TWO_SIDED|95.0|-53.6|-41.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-41.3|-53.6|<0.0001
70883698|NCT01644175|141251445|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.3|||<|0.0001|TWO_SIDED|95.0|-55.3|-43.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-43.3|-55.3|<0.0001
70883699|NCT01644175|141251446|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.8|||<|0.0001|TWO_SIDED|95.0|-41.3|-30.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-30.3|-41.3|<0.0001
70883700|NCT01644175|141251447|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.5|||<|0.0001|TWO_SIDED|95.0|-43.0|-32.0||Threshold for significance ≤0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-32.0|-43.0|<0.0001
70883701|NCT01644175|141251448|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.5|||<|0.0001|TWO_SIDED|95.0|-43.5|-31.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-31.4|-43.5|<0.0001
70883702|NCT01644175|141251449|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.4|||<|0.0001|TWO_SIDED|95.0|-46.4|-34.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-34.4|-46.4|<0.0001
70883703|NCT01644175|141251450|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.0|||<|0.0001|TWO_SIDED|95.0|-29.3|-20.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-20.7|-29.3|<0.0001
70883704|NCT01644175|141251451|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.2|||<|0.0001|TWO_SIDED|95.0|-43.7|-32.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-32.7|-43.7|<0.0001
70883705|NCT01644175|141251452|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.1|||<|0.0001|TWO_SIDED|95.0|-46.2|-33.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-33.9|-46.2|<0.0001
70963321|NCT04561765|141431384|SUPERIORITY|||||||0.963|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P values at discharge.||||0.963
70883706|NCT01644175|141251453|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.4|||<|0.0001|TWO_SIDED|95.0|-31.1|-21.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-21.7|-31.1|<0.0001
70883707|NCT01644175|141251454|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.0|||<|0.0001|TWO_SIDED|95.0|-51.6|-34.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-34.3|-51.6|<0.0001
70883708|NCT01644175|141251455|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|38.5|||<|0.0001|TWO_SIDED|95.0|16.5|89.8||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||89.8|16.5|<0.0001
70883709|NCT01644175|141251456|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|50.0|||<|0.0001|TWO_SIDED|95.0|20.6|121.0||Threshold for significance ≤ 0.05|Regression, Logistic|Multiple imputation approach followed by logistic regression model|Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||121.0|20.6|<0.0001
70883710|NCT01644175|141251457|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-14.6|||<|0.0001|TWO_SIDED|95.0|-21.3|-7.9||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-7.9|-21.3|<0.0001
70883711|NCT01644175|141251458|SUPERIORITY_OR_OTHER||LS Mean Difference|7.3||||0.0001|TWO_SIDED|95.0|3.6|11.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||11.0|3.6|0.0001
70883712|NCT01644175|141251459|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.6||||0.8699|TWO_SIDED|95.0|-8.3|7.0||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||7.0|-8.3|0.8699
70883713|NCT00181961|141251509|SUPERIORITY|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||.016
70963322|NCT04561765|141431384|SUPERIORITY|||||||0.916|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P values at discharge.||||0.916
70883714|NCT01667978|141251510|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
70883715|NCT01324349|141251511|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.0|||<|0.0001|||||||Log Rank||Median difference equals control median minus Hemostatic Patch median in minutes.|The primary effectiveness endpoint was time to hemostasis. The Kaplan-Meier method was used to estimate the survival distribution and to obtain the estimated median time to hemostasis for each treatment. Subjects who did not achieve hemostasis by 10 minutes were to be censored as of that time point. For each treatment, 95% Brookmeyer-Crowley confidence intervals for the median were computed based upon the sign test.||||<0.0001
70963323|NCT04561765|141431385|SUPERIORITY|||||||0.005|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.005
70963324|NCT04561765|141431385|SUPERIORITY|||||||0.27|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.270
70963325|NCT04561765|141431385|SUPERIORITY|||||||0.177|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.177
70963326|NCT04561765|141431385|SUPERIORITY|||||||0.3|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P Value at follow-up.||||0.300
70963327|NCT04561765|141431385|SUPERIORITY|||||||0.996|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.996
70963328|NCT04561765|141431385|SUPERIORITY|||||||0.334|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.334
70883716|NCT01324349|141251512|SUPERIORITY_OR_OTHER||Risk Difference (RD)|23.2||||0.0339|TWO_SIDED|95.0|1.9|47.3|||Suissa and Shuster test||Risk difference equals percentage hemostasis for Hemostatic Patch minus percentage hemostasis for control.|The secondary effectiveness endpoint was hemostasis within 3 minutes. The number and percentage of subjects who achieved hemostasis within 3 minutes are presented for each treatment group. The proportions of subjects who achieved hemostasis within 3 minutes were compared between treatments using the Suissa and Shuster test. Additionally, a 95% Blyth-Still-Casella confidence interval for the true proportion was computed for each treatment.||47.3|1.9|0.0339
70883717|NCT01324349|141251513|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.5||||0.5029|||||||Fisher Exact||Risk difference equals percent of subjects with any treatment emergent adverse events in control group minus percent of subjects with any treatment emergent adverse events in Hemostatic Patch group.|The incidence of subjects experiencing treatment-emergent adverse events (TEAEs) (defined under this protocol as Adverse Events) was summarized by MedDRA system organ class (SOC) and preferred term (PT) for each treatment group for the safety population. Tests for differences between the two treatments in the proportion of subjects experiencing any adverse event were made using Fisher's Exact Test.||||0.5029
70883718|NCT02531321|141251514|OTHER|Unpaired t test with Welch's correction|||||<|0.05|||||||t-test, 2 sided|||||||<.05
70883719|NCT02013167|141251517|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.012|TWO_SIDED|95.0|0.55|0.93|||Stratified Log Rank|Stratified by age (\< 35 years; ≥ 35 years), prior salvage therapy (yes vs. no), and prior allogeneic HSCT (yes vs. no).|Hazard ratio obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicated a lower average event rate and longer survival time for blinatumomab relative to SOC chemotherapy.|||0.93|0.55|0.012
70883720|NCT02013167|141251518|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|17.9|||<|0.001|TWO_SIDED|95.0|9.6|26.2|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors: age (\< 35 vs. ≥ 35), prior salvage therapy (yes vs. no), and prior allogeneic HSCT (yes vs. no).||||26.2|9.6|< 0.001
70883721|NCT02013167|141251519|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|19.3|||<|0.001|TWO_SIDED|95.0|9.9|28.7|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors: age (\< 35 vs. ≥ 35), prior salvage therapy (yes vs. no), and prior allogeneic HSCT (yes vs. no).||||28.7|9.9|< 0.001
70883722|NCT02013167|141251520|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.55|||||TWO_SIDED|95.0|0.43|0.71|||||The hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer survival for Blinatumomab relative to SOC Chemotherapy.|||0.71|0.43|
70883723|NCT01113879|141251529|OTHER||||||<|0.001|TWO_SIDED|85.0|||||Weighted Tau U|||Weighted Tau U effect size mean values in Block 1 of treatment (no aerobic exercise or stretching) were compared to weighted Tau U mean values in Block 2 of treatment (aerobic exercise or stretching adjuvant).||||< 0.001
70883724|NCT03865329|141251579|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||0.13
70883725|NCT03865329|141251580|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
70883726|NCT03865329|141251582|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.10
70883727|NCT03865329|141251583|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||0.25
70883728|NCT00526058|141251588|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of the Futura system to the Secura system would be demonstrated if the upper bound of the 90% confidence interval (CI) for the difference between the two systems (Secura-Futura) in percent change of LDL-C measurements from pre- to post-treatment is less than the noninferiority margin 5.7%.||||||0.005|TWO_SIDED|90.0|||||ANOVA|||||||0.005
70883729|NCT01714310|141251591|SUPERIORITY|||||||0.58||||||Group: F=.31, df=1/140|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).||||||.58
70883730|NCT01714310|141251591|SUPERIORITY|||||||0.85||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=.03, df=1/140||||||.85
70883731|NCT01714310|141251591|SUPERIORITY|||||||0.26||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=1.28, df=1/140||||||.26
70883732|NCT01714310|141251592|SUPERIORITY|||||||0.97||||||Group: F=0.00, df=1/44|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline through week 12) and time2 (weeks 4-12).||||||.97
70883733|NCT01714310|141251592|SUPERIORITY||||||<|0.0002||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=136.22, df=1/44||||||<.0002
70963329|NCT04561765|141431387|SUPERIORITY|||||||0.212|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.212
70883734|NCT01714310|141251592|SUPERIORITY||||||<|0.0001||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=64.90, df=1/44||||||<.0001
70883735|NCT01714310|141251593|SUPERIORITY||||||<|0.0001||||||Time: F=41.85, df=1/89, p\<.0001.|Mixed Models Analysis|Linear regression of outcome change over time within single group.||||||<0.0001
70883736|NCT01714310|141251594|SUPERIORITY||||||<|0.0001||||||Time: F=26.65, df=1/92, p \<.0001.|Mixed Models Analysis|Linear regression of outcome change over time within single group.||||||<0.0001
70883737|NCT01714310|141251595|SUPERIORITY||||||<|0.0001||||||Time: F=40.35, df=1/89, p \< .0001.|Mixed Models Analysis|Linear regression of outcome change over time within single group.||||||<0.0001
70883738|NCT01714310|141251596|SUPERIORITY||||||<|0.0001||||||Time: F=26.36, df=1/29, p \<.0001.|Mixed Models Analysis|Linear regression of outcome change over time within single group.||||||<0.0001
70883739|NCT01714310|141251597|SUPERIORITY|||||||0.44||||||Group: F=.60, df=1/157|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).||||||.44
70883740|NCT01714310|141251597|SUPERIORITY||||||<|0.0001||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=22.39, df=1/157||||||<.0001
70883741|NCT01714310|141251597|SUPERIORITY|||||||0.04||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=4.40, df=1/157||||||.04
70883742|NCT01714310|141251598|SUPERIORITY|||||||0.05||||||Group: F=3.81, df=1/145|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|||No significant group\*time interactions. Group trend likely due to baseline differences.|||.05
70883743|NCT01714310|141251598|SUPERIORITY|||||||0.0001||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Tie: F=15.28, df=1/145||||||.0001
70883744|NCT01714310|141251598|SUPERIORITY|||||||0.02||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=5.42, df=1/145||||||.02
70883745|NCT01714310|141251599|SUPERIORITY|||||||0.76|||||||Chi-squared|Chi Square = .10, df=1, p=.76||||||.76
70883746|NCT01714310|141251600|SUPERIORITY|||||||0.38||||||Group: F=.78, df=1/220|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline through week 12) and time2 (weeks 4-12).||||||.38
70883747|NCT01714310|141251600|SUPERIORITY|||||||0.42||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=.66, df=1/220||||||.42
70883748|NCT01714310|141251600|SUPERIORITY|||||||0.13||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=.66, df=1/220||||||.13
70883749|NCT01714310|141251601|SUPERIORITY|||||||0.21||||||Group: F=1.56, df=1/222|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).||||||.21
70883750|NCT01714310|141251601|SUPERIORITY||||||<|0.0001||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=63.11, df=1/222||||||<.0001
70883751|NCT01714310|141251601|SUPERIORITY|||||||0.0004||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=12.86, df=1/222||||||.0004
70963330|NCT04561765|141431387|SUPERIORITY|||||||0.965|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.965
70883752|NCT01714310|141251602|SUPERIORITY|||||||0.02||||||Group: F=5.42, df=1/223|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).||||||.02
70883753|NCT01714310|141251602|SUPERIORITY|||||||0.18||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=1.77, df=1/223||||||.18
70883754|NCT01714310|141251602|SUPERIORITY|||||||0.49||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=.47, df=1/223||||||.49
70883755|NCT01714310|141251603|SUPERIORITY|||||||0.9||||||Group: F=.02, df=1/223|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).||||||.90
70883756|NCT01714310|141251603|SUPERIORITY|||||||0.21||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=1.60, df=1/223||||||.21
70883757|NCT01714310|141251603|SUPERIORITY|||||||0.73||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=.12, df=1/223||||||.73
70883758|NCT01714310|141251604|SUPERIORITY|||||||0.15||||||Group: F=2.05, df=1/223|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).||||||.15
70883759|NCT01714310|141251604|SUPERIORITY|||||||0.59||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=.29, df=1/223||||||.59
70883760|NCT01714310|141251604|SUPERIORITY|||||||0.14||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=2.15, df=1/223||||||.14
70883761|NCT02822508|141251608|SUPERIORITY|||||||0.034|||||||Cochran-Mantel-Haenszel|||||||0.034
70883762|NCT00654381|141251609|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.04|-0.7|||ANCOVA|Model includes treatment,baseline HbA1c, and number of previous antidiabetic medication||Linagliptin 5 mg vs placebo at week 12||-0.7|-1.04|<0.0001
70963331|NCT04561765|141431387|SUPERIORITY|||||||0.294|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.294
70963332|NCT04561765|141431387|SUPERIORITY|||||||0.207|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.207
70963333|NCT04561765|141431387|SUPERIORITY|||||||0.158|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.158
70963334|NCT04561765|141431387|SUPERIORITY|||||||0.988|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.988
70883763|NCT00654381|141251609|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.05|-0.71|||ANCOVA|Model includes treatment,baseline HbA1c, and number of previous antidiabetic medication||Linagliptin 10 mg vs placebo at week 12||-0.71|-1.05|<0.0001
70883764|NCT00654381|141251610|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.09||0.0003|TWO_SIDED|95.0|-0.49|-0.15|||ANCOVA|Model includes treatment,baseline HbA1c, and number of previous antidiabetic medication||||-0.15|-0.49|0.0003
70883765|NCT00654381|141251610|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.56|-0.21|||ANCOVA|Model includes treatment,baseline HbA1c, and number of previous antidiabetic medication||Linagliptin 10 mg vs voglibose at week 26||-0.21|-0.56|<0.0001
70883766|NCT00654381|141251614|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-19.7|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-25.4|-14.0|||ANCOVA|Model includes treatment,baseline FPG, and number of previous antidiabetic medication||Linagliptin 5 mg vs placebo at week 12||-14.0|-25.4|<0.0001
70883767|NCT00654381|141251614|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-20.4|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-26.2|-14.7|||ANCOVA|Model includes treatment,baseline FPG, and number of previous antidiabetic medication||Linagliptin 10 mg vs placebo at week 12||-14.7|-26.2|<0.0001
70883768|NCT00654381|141251615|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.9|STANDARD_ERROR_OF_MEAN|3.1||0.0239|TWO_SIDED|95.0|-13.0|-0.9|||ANCOVA|Model includes treatment,baseline FPG, and number of previous antidiabetic medication||Linagliptin 5 mg vs Voglibose at week 26||-0.9|-13.0|0.0239
70883769|NCT00654381|141251615|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-9.8|STANDARD_ERROR_OF_MEAN|3.1||0.0015|TWO_SIDED|95.0|-15.8|-3.8|||ANCOVA|Model includes treatment,baseline FPG, and number of previous antidiabetic medication||Linagliptin 10 mg vs voglibose at week 26||-3.8|-15.8|0.0015
70883770|NCT04164901|141251632|SUPERIORITY||Cox Proportional Hazard|0.39|||<|1e-07|TWO_SIDED|95.0|0.27|0.56|||Kaplan-Meier|||||0.56|0.27|<0.0000001
70883771|NCT04164901|141251635|SUPERIORITY||Odds Ratio (OR)|4.88||||0.003|TWO_SIDED|95.0|1.56|15.25|||Cochran-Mantel-Haenszel||Odds ratio was calculated with placebo as the control (denominator).|||15.25|1.56|0.003
70883772|NCT04164901|141251642|SUPERIORITY||Cox Proportional Hazard|0.35||||2.4e-07|TWO_SIDED|95.0|0.23|0.54|||Kaplan-Meier|||||0.54|0.23|0.00000024
70883773|NCT03144180|141251685|EQUIVALENCE|A two-sided two-sample t-test with 80% power, an alpha of 0.05, and a common standard deviation of 14 seconds was used to determine the sample size.|Confidence Interval for a mean|49.0|STANDARD_DEVIATION|47.0|||TWO_SIDED|95.0|15.459|82.571||||||||82.571|15.459|
70883774|NCT03144180|141251686|EQUIVALENCE|A two-sided two-sample t-test with 80% power, an alpha of 0.05, and a common standard deviation of 14 seconds was used to determine the sample size.||||||0.0295||||||The threshold for statistical significance was p = 0.05.|Chi-squared|||||||0.0295
70883775|NCT03144180|141251687|EQUIVALENCE|A two-sided two-sample t-test with 80% power, an alpha of 0.05, and a common standard deviation of 14 seconds was used to determine the sample size.||||||0.403||||||The threshold for statistical significance was p = 0.05.|Chi-squared|||||||0.403
70883776|NCT03712410|141251762|OTHER|Group Comparisons||||||0.186||||||p-value for Difference (FollowUp-Baseline) Generalised Anxiety Disorder Assessment (GAD-7)|Kruskal-Wallis|||||||0.1860
70883777|NCT03712410|141251762|OTHER|Group Comparisons||||||0.2752||||||p-value for Difference (FollowUp-Baseline) Patient Health Questionnaire 9 (PHQ9)|Kruskal-Wallis|||||||0.2752
70883778|NCT03712410|141251762|OTHER|Group Comparisons||||||0.6233||||||p-value for Difference (FollowUp-Baseline) Caregiver Quality of Life Index (CQLI-R)|Kruskal-Wallis|||||||0.6233
70883779|NCT03712410|141251763|OTHER|Group Comparison||||||0.5638||||||p-value for Difference (FollowUp-Baseline) Generalised Anxiety Disorder Assessment (GAD-7)|Wilcoxon (Mann-Whitney)|||||||0.5638
70883780|NCT03712410|141251763|OTHER|Group Comparisons||||||0.9848||||||p-value for Difference (FollowUp-Baseline) Patient Health Questionnaire 9 (PHQ9)|Wilcoxon (Mann-Whitney)|||||||0.9848
70883781|NCT03712410|141251763|OTHER|Group Comparisons||||||0.9169||||||p-value for Difference (FollowUp-Baseline) Caregiver Quality of Life Index (CQLI-R)|Wilcoxon (Mann-Whitney)|||||||0.9169
70883782|NCT03712410|141251764|OTHER|Group Comparisons|||||<|0.0001||||||p-value for Generalised Anxiety Disorder Assessment (GAD-7) for arm Traditional PISCES|Wilcoxon Signed Rank Test|||||||<0.0001
70883783|NCT03712410|141251764|OTHER|Group Comparisons|||||<|0.0001||||||p-value for Patient Health Questionnaire 9 (PHQ9) for arm Traditional PISCES|Wilcoxon Signed Rank Test|||||||<0.0001
70883784|NCT03712410|141251764|OTHER|Group Comparisons||||||0.0155||||||p-value for Caregiver Quality of Life Index (CQLI-R) for arm Traditional PISCES|Wilcoxon Signed Rank Test|||||||0.0155
70883785|NCT03712410|141251764|OTHER|Group Comparisons|||||<|0.0001||||||p-value for Generalised Anxiety Disorder Assessment (GAD-7) for arm Online PISCES|Wilcoxon Signed Rank Test|||||||<0.0001
70883786|NCT03712410|141251764|OTHER|Group Comparisons|||||<|0.0001||||||p-value for Patient Health Questionnaire 9 (PHQ9) for arm Online PISCES|Wilcoxon Signed Rank Test|||||||<0.0001
70883787|NCT03712410|141251764|OTHER|Group Comparisons||||||0.0504||||||p-value for Caregiver Quality of Life Index (CQLI-R) for arm Online PISCES|Wilcoxon Signed Rank Test|||||||0.0504
70883788|NCT03316885|141251765|OTHER|The performance target in support of the primary effectiveness was percentage of eyes achieving objective monocular BCDVA at 1 year postoperative (Visit 5A) compared to the a priori SPE percentage of 92.5%. This is for the All Implanted Analysis Set (AAS) (as reported in EN ISO 11979-7:2014).|Comparison|100.0|||||ONE_SIDED|95.0||100.0||||||||100.0||
70883789|NCT03316885|141251766|OTHER|The performance target in support of the primary effectiveness was percentage of eyes achieving objective monocular BCDVA at 1 year postoperative (Visit 5A) compared to the a priori SPE percentage of 92.5%. This is for the All Implanted Analysis Set (AAS) (as reported in EN ISO 11979-7:2014).|Comparison|100.0|||||ONE_SIDED|95.0||100.0||||||||100.0||
70883790|NCT00828191|141251818|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis (H0) was tested against the alternative by calculating a two-sided 95% confidence interval for the difference in ongoing pregnancy rates. If the lower bound of the 95% confidence interval was greater than the non-inferiority limit (-10.0%), the null hypothesis was rejected and the test group considered not inferior to the control treatment.|Difference in pregnancy rates|-2.5||||0.52|TWO_SIDED|95.0|-9.4|4.4|||Fisher Exact|||"The non -inferiority hypothesis to be tested for the primary endpoint was that the ongoing pregnancy rate (oPR) in the test group (Pe)was lower than the oPR in the control group (Pc)against the alternative one that the oPR in the test group was equal to or higher than the oPR in the control group.~H0 : Pc\>= Pe + d(-10%) H1 : Pc\< Pe + d(-10%)"||4.4|-9.4|0.52
70883791|NCT00828191|141251819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|1.48||0.54|TWO_SIDED|95.0|-7.6|4.0|||ANOVA|||||4.0|-7.6|0.54
70883792|NCT00828191|141251820|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.0||||0.62|TWO_SIDED|95.0|-8.8|4.8|||Fisher Exact|||||4.8|-8.8|0.62
70883793|NCT00962104|141251835|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.78|||<|0.001|TWO_SIDED|95.0|-7.66|-3.91||Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline CAARS-Inv:SV 18-Item Total ADHD Symptom score .|ANCOVA|||||-3.91|-7.66|<0.001
70883794|NCT00962104|141251836|SUPERIORITY_OR_OTHER||Slope|4.76|||<|0.001|TWO_SIDED|95.0|1.97|7.56||First gated secondary outcome measure. A gatekeeper strategy (Westfall and Krishen 2001) controlled experiment-wise type I error for 2 QoL measures. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|ANCOVA|Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline AAQoL total score.||||7.56|1.97|<0.001
70883795|NCT00962104|141251837|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.82||||0.289|TWO_SIDED|95.0|-5.2|1.56||Second gated secondary outcome measure. A gatekeeper strategy (Westfall and Krishen 2001) controlled experiment-wise type I error for 2 QoL measures. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|ANCOVA|Least Squares Mean difference between 2 treatment groups from Type III sum of squares analysis of covariance model:Change=treatment+country+baseline.||||1.56|-5.20|0.289
70883796|NCT00962104|141251838|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.18|||<|0.001|TWO_SIDED|95.0|-8.13|-4.22|||Mixed Models Analysis|||||-4.22|-8.13|<0.001
70883797|NCT00962104|141251839|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.18|||<|0.001|TWO_SIDED|95.0|-8.21|-4.14|||Mixed Models Analysis|||||-4.14|-8.21|<0.001
70883798|NCT00962104|141251840|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.59||||0.001|TWO_SIDED|95.0|-5.73|-1.45||This is the p-value for the Raw Behavioral Regulation Index score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||-1.45|-5.73|0.001
70883799|NCT00962104|141251840|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.29|||<|0.001|TWO_SIDED|95.0|-9.28|-3.31||This is the p-value for the Raw MI score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||-3.31|-9.28|<0.001
70883800|NCT00962104|141251840|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-9.76|||<|0.001|TWO_SIDED|95.0|-14.75|-4.78||This is the p-value for the Global Executive Composite Index score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||-4.78|-14.75|<0.001
70883801|NCT00962104|141251841|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.93||||0.092|TWO_SIDED|95.0|-4.18|0.32||This is the p-value for the Raw Behavioral Regulation Index score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||0.32|-4.18|0.092
70883802|NCT00962104|141251841|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.62||||0.272|TWO_SIDED|95.0|-4.52|1.28||This is the p-value for the Raw MI Index score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||1.28|-4.52|0.272
70883803|NCT00962104|141251841|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.55||||0.153|TWO_SIDED|95.0|-8.43|1.32||This is the p-value for the Raw Global Executive Composite Index score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||1.32|-8.43|0.153
70883804|NCT00962104|141251842|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.67|-0.27||Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||-0.27|-0.67|<0.001
70883805|NCT00962104|141251843|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed using an analysis of variance (ANOVA) with term for treatment and country.|ANOVA|||||||<0.001
70883806|NCT00962104|141251844|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.05||||0.869|TWO_SIDED|95.0|-0.71|0.6||Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||0.60|-0.71|0.869
70883807|NCT00962104|141251845|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.05||||0.87|TWO_SIDED|95.0|-0.59|0.5||Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||0.50|-0.59|0.870
70883808|NCT03274986|141251848|SUPERIORITY||Least Squares Mean Difference|-0.164|STANDARD_ERROR_OF_MEAN|0.0168|<|0.001|TWO_SIDED|95.0|-0.197|-0.131||2-sided p-value reported. A hypothesis test was based on a two sample t-test, with a type I error rate of 0.025, 1-sided.|t-test, 2 sided||Least squares mean difference (DFT015 - SN60WF)|||-0.131|-0.197|<0.001
70883809|NCT03274986|141251849|NON_INFERIORITY|Non-Inferiority margin was 0.1 logMAR.|Least Squares Mean Difference|0.052|STANDARD_ERROR_OF_MEAN|0.0127|||ONE_SIDED|95.0||0.073||The hypothesis test was based on a two-sample t-test, with a type I error rate of 0.05, 1-sided.|t-test, 2 sided||Least squares mean difference (DFT015 - SN60WF). The 1-sided 95% Upper Confidence Limit is presented.|||0.073||
70883810|NCT03274986|141251850|OTHER||Difference in depth of focus|0.54|||||TWO_SIDED|||||Hypothesis testing was not pre-specified.|||Difference in depth of focus (DFT015 - SN60WF)|||||
70883811|NCT03274986|141251854|SUPERIORITY||Least Squares Mean Difference|-0.156|STANDARD_ERROR_OF_MEAN|0.0206|<|0.001|TWO_SIDED|95.0|-0.197|-0.115||2-sided p-value reported. A hypothesis test was based on a two sample t-test, with a type I error rate of 0.025, 1-sided.|t-test, 2 sided||Least squares mean difference (DFT015 - SN60WF)|||-0.115|-0.197|<0.001
70883812|NCT03274986|141251855|OTHER||Difference in percentage|18.0|||||TWO_SIDED|95.0|9.65|27.37|||||95% CI for the difference (DFT015 - SN60WF) is estimated using Miettinen-Nurminen method (1985).|||27.37|9.65|
70963335|NCT04561765|141431389|SUPERIORITY|||||||0.295|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.295
70963336|NCT04561765|141431389|SUPERIORITY|||||||0.718|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.718
70963337|NCT04561765|141431389|SUPERIORITY|||||||0.738|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.738
70963338|NCT04561765|141431389|SUPERIORITY|||||||0.797|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.797
70963339|NCT04561765|141431389|SUPERIORITY|||||||0.26|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.260
70963340|NCT04561765|141431389|SUPERIORITY|||||||0.616|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.616
70963341|NCT04561765|141431390|SUPERIORITY|||||||0.333|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.333
70883813|NCT00603746|141251862|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.275|||<|0.001||95.0|0.18|0.37|||ANCOVA|||||0.370|0.180|<0.001
70883814|NCT00603746|141251862|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.272|||<|0.001|TWO_SIDED|95.0|0.178|0.367|||ANCOVA|||||0.367|0.178|<0.001
70883815|NCT00603746|141251862|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.264|||<|0.001|TWO_SIDED|95.0|0.171|0.357|||ANCOVA|||||0.357|0.171|<0.001
70883816|NCT00603746|141251862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.225|||<|0.001|TWO_SIDED|95.0|0.131|0.32|||ANCOVA|||||0.320|0.131|<0.001
70883817|NCT00603746|141251862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|||<|0.001|TWO_SIDED|95.0|0.105|0.291|||ANCOVA|||||0.291|0.105|<0.001
70883818|NCT01524627|141251886|SUPERIORITY|||||||0.0004|||||||t-test, 2 sided|||||||0.0004
70883819|NCT01524627|141251886|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
70883820|NCT02196324|141251929|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.34|=|0.0111|TWO_SIDED|95.0|-1.5|-0.2|||Mixed Models Analysis|||||-0.2|-1.5|= 0.0111
70883821|NCT02196324|141251930|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.43|=|0.0248|TWO_SIDED|95.0|-1.8|-0.1|||Mixed Models Analysis|||||-0.1|-1.8|= 0.0248
70883822|NCT02196324|141251931|SUPERIORITY||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.47||0.0005|TWO_SIDED|95.0|-2.6|-0.7|||Mixed Models Analysis|||||-0.7|-2.6|0.0005
70883823|NCT02196324|141251937|SUPERIORITY||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-1.4|0.0||||||Week 2||-0.0|-1.4|
70883824|NCT02196324|141251937|SUPERIORITY||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-1.7|-0.1||||||Week 4||-0.1|-1.7|
70883825|NCT02196324|141251937|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.0175|TWO_SIDED|95.0|-2.0|-0.2||p-value assume equal variance|t-test, 2 sided|||Week 8||-0.2|-2.0|0.0175
70883826|NCT02196324|141251938|SUPERIORITY||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-3.1|1.6||||||Week 2||1.6|-3.1|
70883827|NCT02196324|141251938|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-2.7|2.3||||||Week 4||2.3|-2.7|
70883828|NCT02196324|141251938|SUPERIORITY||Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-3.6|2.1||||||Week 8||2.1|-3.6|
70883829|NCT02196324|141251939|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.4|0.1||||||Week 2||0.1|-0.4|
70883830|NCT02196324|141251939|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.4|0.2||||||Week 4||0.2|-0.4|
70883831|NCT02196324|141251939|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.6|0.1||||||Week 8||0.1|-0.6|
70883832|NCT02196324|141251940|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.0625|TWO_SIDED|95.0|-0.02|0.72||p-value assume equal variance.|t-test, 2 sided|||||0.72|-0.02|0.0625
70883833|NCT00692770|141251945|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||=|0.258329|TWO_SIDED|95.0|0.78|1.134||One sided P-value was stratified by region, risk of recurrence and previous curative treatment.|Log Rank|||||1.134|0.78|=0.258329
70883834|NCT00692770|141251946|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.891|||=|0.121383|TWO_SIDED|95.0|0.735|1.081||One sided P-value was stratified by region, risk of recurrence and previous curative treatment.|Log Rank|||||1.081|0.735|=0.121383
70883835|NCT00692770|141251947|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.995|||=|0.484742|TWO_SIDED|95.0|0.761|1.3||One-sided P-value was stratified by region, risk of recurrence and previous curative treatment.|Log Rank|||||1.3|0.761|=0.484742
70883836|NCT00692770|141251948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|||<|0.0001|TWO_SIDED|95.0|0.025|0.052|||ANCOVA|||An analysis of covariance (ANCOVA) model was used to estimate the mean difference in the timeadjusted Area Under Curve (AUC) between the two treatment groups, with covariates for baseline scores and stratification factors. To test the treatment effect, a mixed linear model (random coefficient model) was used for the EQ-5D index score. Statistical tests were performed with a 2 sided type I error of 5%.||0.052|0.025|<0.0001
70883837|NCT00692770|141251949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.978|||<|0.0001|TWO_SIDED|95.0|1.797|4.159|||ANCOVA|||An analysis of covariance (ANCOVA) model was used to estimate the mean difference in the timeadjusted Area Under Curve (AUC) between the two treatment groups, with covariates for baseline scores and stratification factors. To test the treatment effect, a mixed linear model (random coefficient model) was used for the EQ-5D VAS score. Statistical tests were performed with a 2 sided type I error of 5%.||4.159|1.797|<0.0001
70883838|NCT00692770|141251950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|||<|0.0001|TWO_SIDED|95.0|3.5|6.7|||ANCOVA|||An ANCOVA model was used to estimate the mean difference in the timeadjusted AUC between the two treatment groups, with covariates for baseline scores and stratification factors. To test the treatment effect, a mixed linear model (random coefficient model) was used for the FACT-HEP score. Statistical tests were performed with a 2 sided type I error of 5%.||6.7|3.5|<0.0001
70883839|NCT00692770|141251951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||<|0.0001|TWO_SIDED|95.0|1.4|3.6|||ANCOVA|||An ANCOVA model was used to estimate the mean difference in the timeadjusted AUC between the two treatment groups, with covariates for baseline scores and stratification factors. To test the treatment effect, a mixed linear model (random coefficient model) was used for the FACT-G score. Statistical tests were performed with a 2 sided type I error of 5%.||3.6|1.4|<0.0001
70883840|NCT00692770|141251952|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.562|||||TWO_SIDED|95.0|1.241|1.965|||||Significance of the biomarker main effect (RFS) and its corresponding hazard ratio estimate (HR) with 95% CI were reported. HR was expressed as high/low biomarker levels.|||1.965|1.241|
70883841|NCT00692770|141251953|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.747|||||TWO_SIDED|95.0|1.407|2.17|||||Significance of the biomarker main effect (RFS) and its corresponding hazard ratio estimate (HR) with 95% CI were reported. HR was expressed as high/low biomarker levels.|||2.170|1.407|
70883842|NCT00692770|141251954|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.56|||||TWO_SIDED|95.0|1.206|2.018|||||Significance of the biomarker main effect (RFS) and its corresponding hazard ratio estimate (HR) with 95% CI were reported. HR was expressed as high/low biomarker levels.|||2.018|1.206|
70883843|NCT01275066|141252114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.5|STANDARD_ERROR_OF_MEAN|9.35||0.0174||95.0||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p\<0.05 or either of p-values is p\<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category as covariates.||||||0.0174
70883844|NCT01275066|141252114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|9.29||0.9542||||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p\<0.05 or either of p-values is p\<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category as covariates.||||||0.9542
70963342|NCT04561765|141431390|SUPERIORITY|||||||0.003|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.003
70883845|NCT01275066|141252115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|1.66||0.4935||||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p\<0.05 or either of p-values is p\<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category, and baseline 3MSCT as covariates.||||||0.4935
70883846|NCT01275066|141252115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|1.66||0.7783||||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p\<0.05 or either of p-values is p\<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category, and baseline 3MSCT as covariates.||||||0.7783
70883847|NCT01275066|141252116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.7|STANDARD_ERROR_OF_MEAN|4.2|<|0.0001||||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p\<0.05 or either of p-values is p\<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category, and baseline uKS normalized for creatinine, as covariates.||||||<0.0001
70883848|NCT01275066|141252116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.2|STANDARD_ERROR_OF_MEAN|4.19|<|0.0001||||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p\<0.05 or either of p-values is p\<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category, and baseline uKS normalized for creatinine, as covariates.||||||<0.0001
70883849|NCT02623803|141252125|SUPERIORITY|||||||0.1459|||||||Wilcoxon (Mann-Whitney)|||||||0.1459
70883850|NCT02623803|141252126|SUPERIORITY|||||||0.205|||||||Wilcoxon (Mann-Whitney)|||||||0.2050
70883851|NCT02623803|141252127|SUPERIORITY|||||||0.3989|||||||Wilcoxon (Mann-Whitney)|||||||0.3989
70883852|NCT02623803|141252128|SUPERIORITY|||||||0.5285|||||||Wilcoxon (Mann-Whitney)|||||||0.5285
70883853|NCT02623803|141252129|SUPERIORITY|||||||0.0697|||||||Wilcoxon (Mann-Whitney)|||||||0.0697
70883854|NCT02623803|141252130|SUPERIORITY|||||||0.1029|||||||Wilcoxon (Mann-Whitney)|||||||0.1029
70883855|NCT02623803|141252131|SUPERIORITY|||||||0.3136|||||||Wilcoxon (Mann-Whitney)|||||||0.3136
70883856|NCT02623803|141252132|SUPERIORITY|||||||0.2196|||||||Wilcoxon (Mann-Whitney)|||||||0.2196
70883857|NCT02623803|141252133|SUPERIORITY|||||||0.3057|||||||Wilcoxon (Mann-Whitney)|||||||0.3057
70883858|NCT02623803|141252134|SUPERIORITY|||||||0.0404|||||||Wilcoxon (Mann-Whitney)|||||||0.0404
70883859|NCT02623803|141252135|SUPERIORITY|||||||0.5314|||||||Wilcoxon (Mann-Whitney)|||||||0.5314
70883860|NCT02623803|141252136|SUPERIORITY|||||||0.3166|||||||Wilcoxon (Mann-Whitney)|||||||0.3166
70883861|NCT02623803|141252137|SUPERIORITY|||||||0.2363|||||||Wilcoxon (Mann-Whitney)|||||||0.2363
70883862|NCT02623803|141252138|SUPERIORITY|||||||0.9171|||||||Wilcoxon (Mann-Whitney)|||||||0.9171
70883863|NCT02623803|141252139|SUPERIORITY|||||||0.4194|||||||Wilcoxon (Mann-Whitney)|||||||0.4194
70883864|NCT02623803|141252140|SUPERIORITY|||||||0.7073|||||||Wilcoxon (Mann-Whitney)|||||||0.7073
70883865|NCT02623803|141252141|SUPERIORITY|||||||0.5107|||||||Wilcoxon (Mann-Whitney)|||||||0.5107
70883866|NCT02623803|141252142|SUPERIORITY|||||||0.8339|||||||Wilcoxon (Mann-Whitney)|||||||0.8339
70883867|NCT02623803|141252143|SUPERIORITY|||||||0.8927|||||||Wilcoxon (Mann-Whitney)|||||||0.8927
70883868|NCT00802412|141252287|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.51|TWO_SIDED|95.0|0.4|6.5|||Regression, Logistic|||||6.5|0.4|0.51
70883869|NCT00802412|141252287|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.45|TWO_SIDED|95.0|0.66|2.55|||Regression, Cox|||||2.55|0.66|.45
70883870|NCT00606892|141252288|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Significant treatment or treatment-by-time interactions were followed up by post hoc comparisons of placebo vs. varenicline for time (Pre- vs. Post-Nicotine infusion) and testing block (Smoking Block vs. Negative Affect Block).|Mixed Models Analysis|||A mixed-effect repeated-measures crossover model with fixed main effect terms of treatment (placebo or varenicline) and time of measurement (Pre-Nicotine or Post-Nicotine) was utilized. Interactions between main effect terms were also analyzed.||||<0.05
70963343|NCT04561765|141431390|SUPERIORITY|||||||0.106|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.106
70883871|NCT00606892|141252289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.0|STANDARD_DEVIATION|40.0|<|0.3|TWO_SIDED|95.0|||||ANOVA|F(1,10)=1.1||||||<0.3
70883872|NCT00606892|141252290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||<|0.05|TWO_SIDED|95.0||||Values of p\<0.05 were considered statistically significant, based on 2-tailed tests. Significant treatment, or treatment-by-time interactions were followed by post hoc comparisons. To account for multiple testing, significance was set at p\<0.016.|Mixed Models Analysis|||A mixed-effect repeated-measures crossover model including fixed main effects for treatment condition (placebo or varenicline), time of measurement and interactions between treatment and time, was utilized. Because multiple measurements were collected before and after each nicotine dose, a change score (maximum post dose score - pre dose baseline) was used in the analysis.||||<0.05
70883873|NCT00606892|141252291|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||Post hoc comparisons of effects of varenicline versus placebo for different nicotine doses were performed and significance was adjusted for multiple testing using a p value of P\<0.016|ANOVA|Two-tailed tests were applied for main effects with P\<0.05||A mixed-effect, repeated-measures, crossover model was used with fixed main effects for treatment (placebo or varenicline), and time after treatment. Interactions between main effects were also analyzed.||||<0.05
70883874|NCT03917420|141252324|OTHER|Correlation|Spearman's Rho|-0.455|||||TWO_SIDED|||||||||||||
70883875|NCT03917420|141252325|OTHER|Correlation|Spearman's Rho|0.152|||||TWO_SIDED|||||||||||||
70883876|NCT03917420|141252326|OTHER|Correlation|Spearman's Rho|0.564|||||TWO_SIDED|||||||||||||
70883877|NCT03917420|141252327|OTHER|Correlation|Spearman's Rho|0.285|||||TWO_SIDED|||||||||||||
70883878|NCT01874262|141252356|SUPERIORITY_OR_OTHER|||||||0.025|||||||Wilcoxon (Mann-Whitney)|||||||0.025
70883879|NCT06049043|141252372|SUPERIORITY||Mean Difference (Final Values)|-5.09|STANDARD_ERROR_OF_MEAN|0.04||0.26|TWO_SIDED|95.0|-14.02|3.84|||t-test, 2 sided|||||3.84|-14.02|0.26
70883880|NCT06049043|141252373|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|4.84||0.44|TWO_SIDED|95.0|-13.43|5.85|||t-test, 2 sided|||||5.85|-13.43|0.44
70883881|NCT06049043|141252374|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.44||0.62|TWO_SIDED|95.0|-0.66|1.1|||t-test, 2 sided|||||1.10|-0.66|0.62
70883882|NCT06049043|141252375|SUPERIORITY||Mean Difference (Final Values)|6.34|STANDARD_ERROR_OF_MEAN|0.04||0.16|TWO_SIDED|95.0|-2.5|15.18|||t-test, 2 sided|||||15.18|-2.50|0.16
70883883|NCT06049043|141252375|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.28|TWO_SIDED|95.0|-0.13|0.04|||Regression, Linear|Controlled for participant characteristics at baseline.||||0.04|-0.13|0.28
70883884|NCT06049043|141252376|SUPERIORITY||Mean Difference (Final Values)|1.98|STANDARD_ERROR_OF_MEAN|4.67||0.67|TWO_SIDED|95.0|-7.31|11.28|||t-test, 2 sided|||||11.28|-7.31|0.67
70883885|NCT06049043|141252376|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.69|TWO_SIDED|95.0|-0.12|0.08|||Regression, Linear|Controlled for participant characteristics at baseline.||||0.08|-0.12|0.69
70883886|NCT06049043|141252377|SUPERIORITY||Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|0.32||0.09|TWO_SIDED|95.0|-0.09|1.18|||t-test, 2 sided|||||1.18|-0.09|0.09
70883887|NCT06049043|141252377|SUPERIORITY||Slope|-0.13|STANDARD_ERROR_OF_MEAN|0.36||0.71|TWO_SIDED|95.0|-0.86|0.59|||Regression, Linear|Controlled for participant characteristics at baseline.||||0.59|-0.86|0.71
70883888|NCT06049043|141252378|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.34||0.08|TWO_SIDED|95.0|-0.07|1.27|||t-test, 2 sided|||||1.27|-0.07|0.08
70883889|NCT06049043|141252378|SUPERIORITY||Slope|-0.36|STANDARD_ERROR_OF_MEAN|0.42||0.39|TWO_SIDED|95.0|-1.21|0.48|||Regression, Linear|Controlled for participant characteristics at baseline.||||0.48|-1.21|0.39
70883890|NCT06049043|141252380|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.22||0.89|TWO_SIDED|95.0|-0.95|0.82|||t-test, 2 sided|||||0.82|-0.95|0.89
70883891|NCT02739269|141252386|SUPERIORITY|||||||0.479|||||||Chi-squared|||||||0.479
70883892|NCT02739269|141252387|SUPERIORITY|||||||0.002|||||||Chi-squared|||||||0.002
70883893|NCT01354496|141252388|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|1.03|||||TWO_SIDED|90.0|0.897|1.18|||||AUC0-∞ was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||1.18|0.897|
70883894|NCT01354496|141252389|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|1.06|||||TWO_SIDED|90.0|0.922|1.22|||||Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||1.22|0.922|
70963344|NCT04561765|141431390|SUPERIORITY|||||||0.541|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.541
70883895|NCT01354496|141252390|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|1.02|||||TWO_SIDED|90.0|0.896|1.16|||||AUC0-∞ was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||1.16|0.896|
70883896|NCT01354496|141252391|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|1.01|||||TWO_SIDED|90.0|0.882|1.15|||||Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||1.15|0.882|
70883897|NCT01354496|141252393|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|0.993|||||TWO_SIDED|90.0|0.951|1.04|||||AUC0-∞ was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||1.04|0.951|
70883898|NCT01354496|141252393|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|0.943|||||TWO_SIDED|90.0|0.905|0.983|||||AUC0-∞ was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||0.983|0.905|
70883899|NCT01354496|141252394|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|0.98|||||TWO_SIDED|90.0|0.926|1.04|||||Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||1.04|0.926|
70883900|NCT01354496|141252394|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|0.94|||||TWO_SIDED|90.0|0.891|0.993|||||Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||0.993|0.891|
70883901|NCT01228747|141252405|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-56.13|STANDARD_ERROR_OF_MEAN|6.15|<|0.0001|TWO_SIDED|95.0|-68.24|-44.02||Statistical testing was 2-sided, and was performed using a significance (α) level of 0.05.|ANCOVA|||"The statistical hypotheses, null hypothesis (H0) and alternate hypothesis (H1), are stated below:~H0: μLEV = μPBO vs. H1: μLEV ≠ μPBO~ANCOVA on the endpoint percentage change from Combined Baseline of GTC seizures per week using treatment and country as factors (categorical predictors) and Combined Baseline GTC seizure frequency per week as a covariate (a continuous predictor) where μLEV and μPBO are adjusted means for LEV and PBO, respectively."||-44.02|-68.24|<0.0001
70883902|NCT02442778|141252423|SUPERIORITY||Least Squares (LS) Mean Difference|0.4||||0.789|TWO_SIDED|95.0|-2.7|3.5||MMRM included fixed effect treatment,visit,treatment-by-visit,baseline,baseline-by-visit,baseline Neuropsychiatric Inventory Agitation/Aggression(NPI AA)(≤6 vs. \>6),falls risk assessment,baseline concomitant use of antipsychotic medications,cohorts.|MMRM|||||3.5|-2.7|0.789
70883903|NCT02442778|141252423|SUPERIORITY||LS Mean Difference|-2.0||||0.2|TWO_SIDED|95.0|-5.0|1.0||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||1.0|-5.0|0.200
70883904|NCT02442778|141252424|SUPERIORITY||LS Mean Difference|0.1||||0.484|TWO_SIDED|95.0|-0.2|0.4||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.4|-0.2|0.484
70883905|NCT02442778|141252424|SUPERIORITY||LS Mean Difference|-0.1||||0.704|TWO_SIDED|95.0|-0.3|0.2||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.2|-0.3|0.704
70883906|NCT02442778|141252425|SUPERIORITY||LS Mean Difference|-0.3||||0.416|TWO_SIDED|95.0|-0.9|0.4||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.4|-0.9|0.416
70963345|NCT04561765|141431390|SUPERIORITY|||||||0.202|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.202
70883907|NCT02442778|141252425|SUPERIORITY||LS Mean Difference|-0.6||||0.066|TWO_SIDED|95.0|-1.3|0.0||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.0|-1.3|0.066
70883908|NCT02442778|141252426|SUPERIORITY||LS Mean Difference|-0.2||||0.249|TWO_SIDED|95.0|-0.5|0.1||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.1|-0.5|0.249
70883909|NCT02442778|141252426|SUPERIORITY||LS Mean Difference|-0.2||||0.199|TWO_SIDED|95.0|-0.5|0.1||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.1|-0.5|0.199
70883910|NCT02442778|141252427|SUPERIORITY||LS Mean Difference|0.0||||0.975|TWO_SIDED|95.0|-0.7|0.7||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.7|-0.7|0.975
70883911|NCT02442778|141252427|SUPERIORITY||LS Mean Difference|-0.3||||0.334|TWO_SIDED|95.0|-1.0|0.3||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.3|-1.0|0.334
70883912|NCT02442778|141252428|SUPERIORITY||LS Mean Difference|-0.1||||0.934|TWO_SIDED|95.0|-2.4|2.2||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||2.2|-2.4|0.934
70883913|NCT02442778|141252428|SUPERIORITY||LS Mean Difference|1.1||||0.342|TWO_SIDED|95.0|-1.2|3.4||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||3.4|-1.2|0.342
70883914|NCT02442778|141252429|SUPERIORITY||LS Mean Difference|0.0||||0.888|TWO_SIDED|95.0|-0.7|0.6||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.6|-0.7|0.888
70963346|NCT04561765|141431390|SUPERIORITY|||||||0.791|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.791
70963347|NCT04561765|141431391|SUPERIORITY|||||||0.026|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.026
70963348|NCT04561765|141431391|SUPERIORITY|||||||0.15|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.15
70963349|NCT04561765|141431391|SUPERIORITY|||||||0.745|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.745
70963350|NCT04561765|141431391|SUPERIORITY|||||||0.021|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.021
70963351|NCT04561765|141431391|SUPERIORITY|||||||0.155|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.155
70963352|NCT04561765|141431391|SUPERIORITY|||||||0.652|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.652
70963353|NCT04561765|141431392|SUPERIORITY|||||||0.343|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.343
70963354|NCT04561765|141431392|SUPERIORITY|||||||0.995|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.995
70963355|NCT04561765|141431392|SUPERIORITY|||||||0.371|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.371
70883915|NCT02442778|141252429|SUPERIORITY||LS Mean Difference|-0.7||||0.019|TWO_SIDED|95.0|-1.3|-0.1||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||-0.1|-1.3|0.019
70963356|NCT04561765|141431392|SUPERIORITY|||||||0.228|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.228
70963357|NCT04561765|141431392|SUPERIORITY|||||||0.282|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.282
70963358|NCT04561765|141431392|SUPERIORITY|||||||0.986|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.986
70963359|NCT04561765|141431393|SUPERIORITY|||||||0.421|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.421
70963360|NCT04561765|141431393|SUPERIORITY|||||||0.556|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.556
70963361|NCT03027557|141431394|SUPERIORITY||||||<|1e-05|||||||ANOVA|||||||< 0.00001
70963362|NCT03027557|141431395|SUPERIORITY||||||<|1e-05|||||||ANOVA|||||||< 0.00001
70963363|NCT03027557|141431396|SUPERIORITY||||||=|0.0019|||||||ANOVA|||||||= 0.0019
70963364|NCT03027557|141431397|SUPERIORITY||||||=|0.096|||||||ANOVA|||||||= 0.096
70963365|NCT03027557|141431398|SUPERIORITY||||||=|0.0001|||||||ANOVA|||||||= 0.0001
70963366|NCT03027557|141431399|SUPERIORITY||||||<|1e-05|||||||ANOVA|||||||< 0.00001
70963367|NCT03027557|141431400|SUPERIORITY||||||=|0.0027|||||||ANOVA|||||||= 0.0027
70963368|NCT03027557|141431401|SUPERIORITY||||||=|0.081|||||||ANOVA|||||||= 0.081
70963369|NCT03027557|141431402|SUPERIORITY||||||=|0.0071|||||||ANOVA|||||||= 0.0071
70963370|NCT03027557|141431403|SUPERIORITY||||||=|0.0001|||||||ANOVA|||||||= 0.0001
70963371|NCT03027557|141431404|SUPERIORITY||||||=|0.0001|||||||Kruskal-Wallis|||||||= 0.0001
70963372|NCT03027557|141431405|SUPERIORITY||||||=|0.38|||||||Kruskal-Wallis|||||||= 0.38
70963373|NCT03027557|141431410|SUPERIORITY||||||=|0.83|||||||Kruskal-Wallis|||||||= 0.83
70963374|NCT03027557|141431413|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||>0.05
70963375|NCT03027557|141431414|SUPERIORITY||||||=|0.0077|||||||ANOVA|||||||= 0.0077
70963376|NCT03027557|141431415|SUPERIORITY||||||=|0.011|||||||ANOVA|||||||= 0.011
70963377|NCT03027557|141431416|SUPERIORITY||||||=|0.011|||||||ANOVA|||||||= 0.011
70963378|NCT03027557|141431417|SUPERIORITY||||||=|0.0001|||||||Kruskal-Wallis|||||||= 0.0001
70963379|NCT03027557|141431418|SUPERIORITY||||||<|1e-05|||||||ANOVA|||||||< 0.00001
70963380|NCT03027557|141431419|SUPERIORITY||||||=|0.0001|||||||Kruskal-Wallis|||||||= 0.0001
70963381|NCT03027557|141431420|SUPERIORITY||||||=|0.0001|||||||ANOVA|||||||= 0.0001
70963382|NCT03027557|141431421|SUPERIORITY||||||=|0.0001|||||||Kruskal-Wallis|||||||= 0.0001
70963383|NCT03027557|141431423|SUPERIORITY||||||=|0.5|||||||Kruskal-Wallis|||||||= 0.5
70963384|NCT03027557|141431424|SUPERIORITY||||||=|0.85|||||||ANOVA|||||||= 0.85
70963385|NCT03027557|141431425|SUPERIORITY||||||=|0.22|||||||ANOVA|||||||= 0.22
70963386|NCT03027557|141431426|SUPERIORITY||||||=|0.18|||||||Kruskal-Wallis|||||||= 0.18
70963387|NCT03836807|141431437|SUPERIORITY|||||||0.02|||||||ANOVA|||||||0.020
70963388|NCT03836807|141431438|SUPERIORITY|||||||0.026|||||||ANOVA|||||||0.026
70963389|NCT03836807|141431439|SUPERIORITY||adjusted least square mean|-0.3||||0.914|TWO_SIDED|95.0|-5.5|5.0|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at Baseline (at 0')||5.0|-5.5|0.914
70963390|NCT03836807|141431439|SUPERIORITY||adjusted least square mean|1.3||||0.685|TWO_SIDED|95.0|-4.9|7.4|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 5'||7.4|-4.9|0.685
70963391|NCT03836807|141431439|SUPERIORITY||adjusted least square mean|-0.3||||0.93|TWO_SIDED|95.0|-7.4|6.8|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 10'||6.8|-7.4|0.930
70963392|NCT03836807|141431439|SUPERIORITY||adjusted least square mean|-2.1||||0.615|TWO_SIDED|95.0|-10.3|6.1|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 15'||6.1|-10.3|0.615
70963393|NCT03836807|141431439|SUPERIORITY||adjusted least square mean|-8.5||||0.051|TWO_SIDED|95.0|-17.0|0.0|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 30'||0|-17.0|0.051
70963394|NCT03836807|141431439|SUPERIORITY||adjusted least square mean|-8.4||||0.043|TWO_SIDED|95.0|-16.6|-0.3|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 45'||-0.3|-16.6|0.043
70883916|NCT02442778|141252430|SUPERIORITY||LS Mean Difference|0.6||||0.756|TWO_SIDED|95.0|-2.9|4.0||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||4.0|-2.9|0.756
70883917|NCT02442778|141252430|SUPERIORITY||LS Mean Difference|-3.6||||0.038|TWO_SIDED|95.0|-7.0|-0.2||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||-0.2|-7.0|0.038
70883918|NCT02442778|141252431|SUPERIORITY||LS Mean Difference|-0.1||||0.468|TWO_SIDED|95.0|-0.3|0.1||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.1|-0.3|0.468
70883919|NCT02442778|141252431|SUPERIORITY||LS Mean Difference|-0.1||||0.158|TWO_SIDED|95.0|-0.3|0.1||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.1|-0.3|0.158
70883920|NCT02442778|141252432|SUPERIORITY||LS Mean Difference|0.1||||0.4|TWO_SIDED|95.0|-0.2|0.4||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.4|-0.2|0.400
70963395|NCT03836807|141431439|SUPERIORITY||adjusted least square mean|-9.0||||0.023|TWO_SIDED|95.0|-16.7|-1.3|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 1h||-1.3|-16.7|0.023
70963396|NCT03836807|141431439|SUPERIORITY||adjusted least square mean|-10.5||||0.009|TWO_SIDED|95.0|-18.2|-2.7|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 1.5h||-2.7|-18.2|0.009
70963397|NCT03836807|141431439|SUPERIORITY||adjusted least square mean|-9.3||||0.018|TWO_SIDED|95.0|-17.0|-1.7|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 2h||-1.7|-17.0|0.018
70963398|NCT03836807|141431439|SUPERIORITY||adjusted least square mean|-5.5||||0.182|TWO_SIDED|95.0|-13.6|2.6|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 3h||2.6|-13.6|0.182
70963399|NCT03836807|141431439|SUPERIORITY||adjusted least square mean|-4.8||||0.236|TWO_SIDED|95.0|-12.9|3.2|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 4h||3.2|-12.9|0.236
70963400|NCT03836807|141431439|SUPERIORITY||adjusted least square mean|-3.6||||0.32|TWO_SIDED|95.0|-10.6|3.5|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 5h||3.5|-10.6|0.320
70963401|NCT03836807|141431439|SUPERIORITY||adjusted least square mean|-2.2||||0.572|TWO_SIDED|95.0|-10.0|5.6|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 6h||5.6|-10.0|0.572
70963402|NCT03836807|141431440|SUPERIORITY||adjusted least square mean|2.7||||0.361|TWO_SIDED|95.0|-3.1|8.4|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 5'||8.4|-3.1|0.361
70963403|NCT03836807|141431440|SUPERIORITY||adjusted least square mean|4.2||||0.298|TWO_SIDED|95.0|-3.8|12.3|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 10'||12.3|-3.8|0.298
70963404|NCT03836807|141431440|SUPERIORITY||adjusted least square mean|8.9||||0.112|TWO_SIDED|95.0|-2.1|19.8|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 15'||19.8|-2.1|0.112
70963405|NCT03836807|141431440|SUPERIORITY||adjusted least square mean|22.3||||0.003|TWO_SIDED|95.0|7.8|36.8|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 30'||36.8|7.8|0.003
70963406|NCT03836807|141431440|SUPERIORITY||adjusted least square mean|21.2||||0.008|TWO_SIDED|95.0|5.6|36.7|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 45'||36.7|5.6|0.008
70963407|NCT03836807|141431440|SUPERIORITY||adjusted least square mean|18.7||||0.018|TWO_SIDED|95.0|3.3|34.0|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 1h||34.0|3.3|0.018
70963408|NCT03836807|141431440|SUPERIORITY||adjusted least square mean|22.3||||0.003|TWO_SIDED|95.0|7.7|37.0|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 1.5h||37.0|7.7|0.003
70963409|NCT03836807|141431440|SUPERIORITY||adjusted least square mean|22.0||||0.003|TWO_SIDED|95.0|8.0|36.1|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 2h||36.1|8.0|0.003
70883921|NCT02442778|141252432|SUPERIORITY||LS Mean Difference|-0.1||||0.566|TWO_SIDED|95.0|-0.3|0.2||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.2|-0.3|0.566
70883922|NCT02442778|141252433|SUPERIORITY||LS Mean Difference|0.0||||0.751|TWO_SIDED|95.0|-0.2|0.3||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.3|-0.2|0.751
70883923|NCT02442778|141252433|SUPERIORITY||LS Mean Difference|-0.1||||0.32|TWO_SIDED|95.0|-0.3|0.1||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.1|-0.3|0.320
70963410|NCT03836807|141431440|SUPERIORITY||adjusted least square mean|16.7||||0.015|TWO_SIDED|95.0|3.4|30.0|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 3h||30.0|3.4|0.015
70883924|NCT02442778|141252434|SUPERIORITY||LS Mean Difference|0.3||||0.782|TWO_SIDED|95.0|-1.8|2.4||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||2.4|-1.8|0.782
70883925|NCT02442778|141252434|SUPERIORITY||LS Mean Difference|0.0||||0.991|TWO_SIDED|95.0|-2.1|2.0||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||2.0|-2.1|0.991
70883926|NCT02442778|141252435|SUPERIORITY||LS Mean Difference|0.6||||0.038|TWO_SIDED|95.0|0.0|1.2||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||1.2|0.0|0.038
70883927|NCT02442778|141252435|SUPERIORITY||LS Mean Difference|0.0||||0.911|TWO_SIDED|95.0|-0.6|0.5||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.5|-0.6|0.911
70883928|NCT02442778|141252437|SUPERIORITY||LS Mean Difference|1.0||||0.236|TWO_SIDED|95.0|-0.6|2.6||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||2.6|-0.6|0.236
70883929|NCT02442778|141252437|SUPERIORITY||LS Mean Difference|0.3||||0.684|TWO_SIDED|95.0|-1.3|1.9||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||1.9|-1.3|0.684
70883930|NCT00615056|141252454|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.273||||0.8268|TWO_SIDED|95.0|0.769|2.108||One-sided log-rank test at alpha = 0.15 significance level was used.|Log Rank|||Differences in PFS between treatment arms was analyzed by 1-sided log rank test, stratified for Eastern Cooperative Oncology Group (ECOG) performance status (0 versus 1) and prior treatment with bevacizumab (yes versus no).||2.108|0.769|0.8268
70883931|NCT00615056|141252454|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.041||||0.5498|TWO_SIDED|95.0|0.553|1.041||One-sided log-rank test at alpha = 0.15 significance level was used.|Log Rank|||Differences in PFS between treatment arms was analyzed by 1-sided log rank test, stratified for ECOG performance status (0 versus 1) and prior treatment with bevacizumab (yes versus no).||1.041|0.553|0.5498
70883932|NCT00615056|141252455|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.355||||0.8828|TWO_SIDED|95.0|0.82|2.238||One-sided log-rank test at alpha = 0.15 significance level was used.|Log Rank|||Differences in OS between treatment arms was analyzed by 1-sided log rank test, stratified for ECOG performance status (0 versus 1) and prior treatment with bevacizumab (yes versus no).||2.238|0.820|0.8828
70883933|NCT00615056|141252455|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.689||||0.1159|TWO_SIDED|95.0|0.373|1.273||One-sided log-rank test at alpha = 0.15 significance level was used.|Log Rank|||Differences in OS between treatment arms was analyzed by 1-sided log rank test, stratified for ECOG performance status (0 versus 1) and prior treatment with bevacizumab (yes versus no).||1.273|0.373|0.1159
70883934|NCT00615056|141252456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.4552|TWO_SIDED|95.0|-15.8|17.7|||Chi-squared|||One-sided Pearson chi square test at alpha = 0.15 significance level was used.||17.7|-15.8|0.4552
70963411|NCT03836807|141431440|SUPERIORITY||adjusted least square mean|10.8||||0.103|TWO_SIDED|95.0|-2.2|23.9|||ANOVA|||at 4h||23.9|-2.2|0.103
70963412|NCT03836807|141431440|SUPERIORITY||adjusted least square mean|5.9||||0.311|TWO_SIDED|95.0|-5.6|17.5|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 5'||17.5|-5.6|0.311
70883935|NCT00615056|141252456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.5235|TWO_SIDED|95.0|-19.1|18.0|||Chi-squared|||One-sided Pearson chi square test at alpha = 0.15 significance level was used.||18.0|-19.1|0.5235
70883936|NCT01888497|141252680|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|13.82|||<|0.001|TWO_SIDED|95.0|10.85|17.4||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For primary endpoint sequential order of testing: triazolam versus (vs) placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||17.40|10.85|<0.001
70883937|NCT01888497|141252680|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For gabapentin versus placebo comparison, the non-inferiority margin for upper limit of 95 percent (%) confidence interval (CI) was 2.4 cm.|Hodges-Lehman estimate|0.55|||||TWO_SIDED|95.0|-0.66|2.33|||||Hodges-Lehman estimate of treatment difference was reported.|For primary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||2.33|-0.66|
70883938|NCT01888497|141252680|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|1.02||||0.134|TWO_SIDED|95.0|-0.39|2.51||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For primary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||2.51|-0.39|0.134
70883939|NCT01888497|141252680|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|2.37|||<|0.001|TWO_SIDED|95.0|1.01|3.98||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For primary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||3.98|1.01|<0.001
70883940|NCT01888497|141252681|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|0.36|||<|0.001|TWO_SIDED|95.0|0.26|0.47||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||0.47|0.26|<0.001
70883941|NCT01888497|141252681|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For gabapentin versus placebo comparison, the non-inferiority margin for upper limit of 95% CI was 0.1 m/sec.|Hodges-Lehman estimate|-0.01|||||TWO_SIDED|95.0|-0.07|0.05|||||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||0.05|-0.07|
70883942|NCT01888497|141252681|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|0.07||||0.012|TWO_SIDED|95.0|0.02|0.12||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||0.12|0.02|0.012
70883943|NCT01888497|141252681|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|0.06||||0.014|TWO_SIDED|95.0|0.01|0.12||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||0.12|0.01|0.014
70883944|NCT01888497|141252682|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|103.25|||<|0.001|TWO_SIDED|95.0|72.0|130.5||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||130.50|72.00|<0.001
70883945|NCT01888497|141252682|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For gabapentin versus placebo comparison, the non-inferiority margin for upper limit of 95% CI was 8 lanes.|Hodges-Lehman estimate|5.0|||||TWO_SIDED|95.0|-4.0|16.5|||||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||16.50|-4.00|
70883946|NCT01888497|141252682|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|3.0||||0.213|TWO_SIDED|95.0|-3.0|9.0||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||9.00|-3.00|0.213
70883947|NCT01888497|141252682|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|11.0||||0.003|TWO_SIDED|95.0|4.0|20.5||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||20.50|4.00|0.003
70883948|NCT04013191|141252686|OTHER||Point Estimate|0.928|||||TWO_SIDED|90.0|0.725|1.19|||ANOVA|||The analysis of variance (ANOVA) model included the fixed effects of age group. The natural logs were taken of the dependent variables and back-transformed after the analysis.||1.19|0.725|
70883949|NCT04013191|141252687|OTHER||Point Estimate|1.22|||||TWO_SIDED|90.0|0.894|1.67|||ANOVA|||The ANOVA model included the fixed effects of age group. The natural logs were taken of the dependent variables and back-transformed after the analysis.||1.67|0.894|
70883950|NCT04013191|141252688|OTHER||Point Estimate|1.22|||||TWO_SIDED|90.0|0.893|1.68|||ANOVA|||The ANOVA model included the fixed effects of age group. The natural logs were taken of the dependent variables and back-transformed after the analysis.||1.68|0.893|
70883951|NCT04013191|141252689|OTHER||Point Estimate|1.02|||||TWO_SIDED|90.0|0.829|1.26|||ANOVA|||The ANOVA model included the fixed effects of age group. The natural logs were taken of the dependent variables and back-transformed after the analysis.||1.26|0.829|
70883952|NCT04013191|141252690|OTHER||Point Estimate|1.18|||||TWO_SIDED|90.0|0.908|1.53|||ANOVA|||The ANOVA model included the fixed effects of age group. The natural logs were taken of the dependent variables and back-transformed after the analysis.||1.53|0.908|
70883953|NCT02904057|141252698|SUPERIORITY||Difference between proportion|92.1|||<|0.0001|TWO_SIDED|95.0|73.4|98.8|||Fisher Exact|||Imputed Data: Difference between proportion of treatment responders and control responders (P\[treatment\] - P\[control\] with confidence interval (CI) was calculated using an exact approach.||98.8|73.4|<0.0001
70883954|NCT02904057|141252698|SUPERIORITY||Difference between proportion|92.1|||<|0.0001|TWO_SIDED|95.0|73.4|98.8|||Fisher Exact|||Observed Data: Difference between proportion of treatment responders and control responders (P\[treatment\] - P\[control\] with CI was calculated using an exact approach.||98.8|73.4|<0.0001
70883955|NCT00913744|141252700|SUPERIORITY_OR_OTHER||Difference in proportions|12.3||||0.262|TWO_SIDED|95.0|-3.7|28.4|||Fisher Exact|P-value is from Fisher's exact test, comparing sham and ocriplasmin.||||28.4|-3.7|0.262
70883956|NCT00805935|141252701|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|95.0|||||Fisher Exact|||||||1.000
70883957|NCT00805935|141252701|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.000
70883958|NCT00805935|141252701|SUPERIORITY_OR_OTHER|||||||0.481||95.0|||||Fisher Exact|||Comparing Progesterone vaginal insert to Progesterone in oil within the menotropin treatments arms.||||0.481
70883959|NCT00805935|141252701|SUPERIORITY_OR_OTHER|||||||0.483|TWO_SIDED|95.0|||||Fisher Exact|||Comparing Progesterone vaginal insert to Progesterone in oil within the follitropin beta treatment group.||||0.483
70883960|NCT01344369|141252723|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.44|||||TWO_SIDED|90.0|93.08|112.75|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||112.75|93.08|
70883961|NCT01344369|141252724|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|100.58|||||TWO_SIDED|90.0|96.66|104.66|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104.66|96.66|
70883962|NCT01344369|141252725|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|100.85|||||TWO_SIDED|90.0|96.43|105.48|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||105.48|96.43|
70883963|NCT01344369|141252726|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|100.59|||||TWO_SIDED|90.0|93.69|108.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.00|93.69|
70883964|NCT01344369|141252727|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.68|||||TWO_SIDED|90.0|92.76|100.77|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||100.77|92.76|
70883965|NCT01344369|141252728|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.44|||||TWO_SIDED|90.0|92.22|100.84|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||100.84|92.22|
70883966|NCT00934544|141252824|SUPERIORITY_OR_OTHER||Kaplan-Meir estimate|28.1|STANDARD_DEVIATION|22.123|<|0.0001|TWO_SIDED|95.0|21.3|36.6|||Cochran-Mantel-Haenszel|||||36.6|21.3|<0.0001
70883967|NCT01218516|141252839|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.23||||0.3519|TWO_SIDED|80.0|0.92|1.63||Per Primary Analysis Cut-Off Date|Log Rank|||||1.63|0.92|0.3519
70883968|NCT01218516|141252839|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.34||||0.1555|TWO_SIDED|80.0|1.03|1.74||Per Final Analysis Cut-Off Date|Log Rank|||||1.74|1.03|0.1555
70883969|NCT00283439|141252847|SUPERIORITY_OR_OTHER|||||||0.9654||||||One-sided test|Satterhwaite t-test|||||||0.9654
70883970|NCT00283439|141252847|SUPERIORITY_OR_OTHER|||||||0.869||||||One-sided test|Satterhwaite t-test|||||||0.8690
70963413|NCT03836807|141431440|SUPERIORITY||adjusted least square mean|2.8||||0.638|TWO_SIDED|95.0|-9.0|14.5|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 6h||14.5|-9.0|0.638
70883971|NCT00283439|141252847|SUPERIORITY_OR_OTHER|||||||0.7133||||||One-sided test|Satterhwaite t-test|||||||0.7133
70883972|NCT00283439|141252848|SUPERIORITY_OR_OTHER|||||||0.294|||||||Fisher Exact|||||||0.294
70883973|NCT00283439|141252848|SUPERIORITY_OR_OTHER|||||||0.608|||||||Fisher Exact|||||||0.608
70883974|NCT00283439|141252848|SUPERIORITY_OR_OTHER|||||||0.603|||||||Fisher Exact|||||||0.603
70883975|NCT00283439|141252849|SUPERIORITY_OR_OTHER|||||||0.091|||||||Satterhwaite t-test|||||||0.091
70883976|NCT00283439|141252849|SUPERIORITY_OR_OTHER|||||||0.3|||||||Satterhwaite t-test|||||||0.300
70883977|NCT00283439|141252849|SUPERIORITY_OR_OTHER|||||||0.881|||||||Satterhwaite t-test|||||||0.881
70883978|NCT00283439|141252850|SUPERIORITY_OR_OTHER|||||||0.576|||||||Fisher Exact|||||||0.576
70883979|NCT00283439|141252850|SUPERIORITY_OR_OTHER|||||||0.588|||||||Fisher Exact|||||||0.588
70883980|NCT00283439|141252850|SUPERIORITY_OR_OTHER|||||||0.421|||||||Fisher Exact|||||||0.421
70883981|NCT00430092|141252877|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mantel Haenszel|||||||<0.0001
70883982|NCT00265616|141252913|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
70883983|NCT00265616|141252914|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||Fisher Exact|||||||0.67
70883984|NCT00265616|141252915|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
70883985|NCT00265616|141252917|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Fisher Exact|||||||0.4
70883986|NCT00265616|141252918|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
70963414|NCT03836807|141431441|SUPERIORITY|||||||0.007|||||||ANOVA|||in the ITT population||||0.007
70883987|NCT01675882|141252960|SUPERIORITY||Relative risk|1.81||||0.0292|TWO_SIDED|95.0|1.05|3.11|||Fisher Exact|||The three pair-wise comparisons of viaskin peanut versus placebo were analyzed using the Bonferroni stepwise procedure, keeping the overall false-positive (alpha) risk below 5%. The comparison of viaskin peanut 250 µg versus placebo is statistically significant at p\<0.05. The subsequent comparison of viaskin peanut 100 µg versus placebo is not statistically significant at p\<0.05. Thus, no conclusion can be made on the comparison of viaskin peanut 50 µg vs placebo.||3.11|1.05|0.0292
70883988|NCT01675882|141252960|SUPERIORITY||Relative risk|1.64||||0.1074|TWO_SIDED|95.0|0.95|2.85|||Fisher Exact|||The three pair-wise comparisons of viaskin peanut versus placebo were analyzed using the Bonferroni stepwise procedure, keeping the overall false-positive (alpha) risk below 5%. The comparison of viaskin peanut 250 µg versus placebo is statistically significant at p\<0.05. The subsequent comparison of viaskin peanut 100 µg versus placebo is not statistically significant at p\<0.05.||2.85|0.95|0.1074
70883989|NCT01675882|141252960|SUPERIORITY||Relative risk|2.0||||0.0108|TWO_SIDED|95.0|1.18|3.38|||Fisher Exact|||The three pair-wise comparisons of viaskin peanut versus placebo were analyzed using the Bonferroni stepwise procedure, keeping the overall false-positive (alpha) risk below 5%. The comparison of viaskin peanut 250 µg versus placebo is statistically significant at p\<0.05.||3.38|1.18|0.0108
70883990|NCT01675882|141252961|SUPERIORITY||Relative risk|2.95||||0.0035|TWO_SIDED|95.0|1.34|6.49|||Fisher Exact|||||6.49|1.34|0.0035
70883991|NCT01675882|141252961|SUPERIORITY||Relative risk|2.38||||0.0453|TWO_SIDED|95.0|1.04|5.47|||Fisher Exact|||||5.47|1.04|0.0453
70883992|NCT01675882|141252961|SUPERIORITY||Relative risk|2.77||||0.0076|TWO_SIDED|95.0|1.25|6.14|||Fisher Exact|||||6.14|1.25|0.0076
70883993|NCT01675882|141252962|SUPERIORITY||Relative risk|1.5||||0.7112|TWO_SIDED|95.0|0.51|4.43|||Fisher Exact|||||4.43|0.51|0.7112
70883994|NCT01675882|141252962|SUPERIORITY||Relative risk|0.47||||0.4048|TWO_SIDED|95.0|0.1|2.28|||Fisher Exact|||||2.28|0.10|0.4048
70883995|NCT01675882|141252962|SUPERIORITY||Relative risk|1.75||||0.4705|TWO_SIDED|95.0|0.62|4.95|||Fisher Exact|||||4.95|0.62|0.4705
70883996|NCT01675882|141252963|SUPERIORITY||Relative risk|0.5||||0.5921|TWO_SIDED|95.0|0.13|1.9|||Fisher Exact|||||1.90|0.13|0.5921
70883997|NCT01675882|141252963|SUPERIORITY||Relative risk|1.43||||0.326|TWO_SIDED|95.0|0.71|2.88|||Fisher Exact|||||2.88|0.71|0.3260
70883998|NCT01675882|141252963|SUPERIORITY||Relative risk|1.05||||1|TWO_SIDED|95.0|0.46|2.38|||Fisher Exact|||||2.38|0.46|1.0000
70963415|NCT03836807|141431441|SUPERIORITY|||||||0.009|||||||ANOVA|||in the PP population||||0.009
70883999|NCT01675882|141252964|SUPERIORITY||Difference in LS mean|70.2||||0.0607|TWO_SIDED|95.0|-2.41|193.69||P-value was based on type III sum of squares from analysis of covariance (ANCOVA) model on log transformed values for peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The least squares (LS) mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||193.69|-2.41|0.0607
70884000|NCT01675882|141252964|SUPERIORITY||Difference in LS mean|97.5||||0.015|TWO_SIDED|95.0|14.45|237.82||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||237.82|14.45|0.0150
70884001|NCT01675882|141252964|SUPERIORITY||Difference in LS mean|242.2|||<|0.0001|TWO_SIDED|95.0|100.03|482.65||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||482.65|100.03|<0.0001
70884002|NCT01675882|141252965|SUPERIORITY||Difference in LS mean|73.9||||0.0372|TWO_SIDED|95.0|2.96|225.85||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||225.85|2.96|0.0372
70884003|NCT01675882|141252965|SUPERIORITY||Difference in LS mean|96.7||||0.0143|TWO_SIDED|95.0|12.92|278.11||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||278.11|12.92|0.0143
70884004|NCT01675882|141252965|SUPERIORITY||Difference in LS mean|260.3|||<|0.0001|TWO_SIDED|95.0|89.83|625.95||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||625.95|89.83|<0.0001
70884005|NCT01675882|141252966|SUPERIORITY||Difference in LS mean|26.1||||0.6596|TWO_SIDED|95.0|-59.58|236.0||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||236.00|-59.58|0.6596
70963416|NCT03836807|141431442|SUPERIORITY|||||||0.004|||||||Log Rank|||||||0.004
70963417|NCT03836807|141431443|SUPERIORITY|||||||0.002|||||||Log Rank|||||||0.002
70963418|NCT03836807|141431444|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.480
70963419|NCT02430051|141431445|SUPERIORITY|||||||0.01|||||||Mixed-effects regression model|Adjusted for attained age and first or second clinic visit.||||||0.01
70884006|NCT01675882|141252966|SUPERIORITY||Difference in LS mean|8.9||||0.8702|TWO_SIDED|95.0|-65.9|189.96||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||189.96|-65.90|0.8702
70884007|NCT01675882|141252966|SUPERIORITY||Difference in LS mean|158.9||||0.063|TWO_SIDED|95.0|-5.5|562.31||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||562.31|-5.50|0.0630
70884008|NCT01675882|141252967|SUPERIORITY||Difference in LS mean|-80.2||||0.6776|TWO_SIDED|95.0|-237.22|782.24||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||782.24|-237.22|0.6776
70884009|NCT01675882|141252967|SUPERIORITY||Difference in LS mean|158.8||||0.5068|TWO_SIDED|95.0|-166.1|1478.83||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||1478.83|-166.10|0.5068
70884010|NCT01675882|141252967|SUPERIORITY||Difference in LS mean|53.8||||0.7972|TWO_SIDED|95.0|-193.9|1085.38||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||1085.38|-193.90|0.7972
70884011|NCT01675882|141252968|SUPERIORITY||Difference in LS mean|120.0||||0.0444|TWO_SIDED|95.0|2.3|321.8||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for cumulative reactive dose at Month 12, including treatment group, baseline cumulative reactive dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean peanut protein cumulative reactive dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||321.80|2.30|0.0444
70884012|NCT01675882|141252968|SUPERIORITY||Difference in LS mean|147.6||||0.0175|TWO_SIDED|95.0|19.67|365.51||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the cumulative reactive dose at Month 12, including treatment group, baseline cumulative reactive dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean peanut protein cumulative reactive dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||365.51|19.67|0.0175
70884013|NCT01675882|141252968|SUPERIORITY||Difference in LS mean|386.0|||<|0.0001|TWO_SIDED|95.0|159.67|771.16||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the cumulative reactive dose at Month 12, including treatment group, baseline cumulative reactive dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean peanut protein cumulative reactive dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||771.16|159.67|<0.0001
70884014|NCT01675882|141252969|SUPERIORITY||Difference in LS mean|-0.6||||0.251|TWO_SIDED|95.0|-1.55|0.52||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the OFC symptom scores at Month 12, including treatment group, Baseline OFC symptom scores, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean OFC score for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||0.52|-1.55|0.2510
70884015|NCT01675882|141252969|SUPERIORITY||Difference in LS mean|-0.2||||0.682|TWO_SIDED|95.0|-1.24|1.05||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the OFC symptom scores at Month 12, including treatment group, Baseline OFC symptom scores, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean OFC score for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||1.05|-1.24|0.6820
70884016|NCT01675882|141252969|SUPERIORITY||Difference in LS mean|0.8||||0.2117|TWO_SIDED|95.0|-0.42|2.47||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the OFC symptom scores at Month 12, including treatment group, Baseline OFC symptom scores, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean OFC score for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||2.47|-0.42|0.2117
70884017|NCT01675882|141252971|SUPERIORITY||Difference in LS mean|17.4||||0.0337|TWO_SIDED|95.0|1.17|38.82||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all Baseline covariates in the analysis set.||38.82|1.17|0.0337
70963420|NCT02430051|141431446|SUPERIORITY|||||||0.25|||||||Mixed-effects regression model|Adjustment for attained age and first and second clinic visit.||||||0.25
70884018|NCT01675882|141252971|SUPERIORITY||Difference in LS mean|26.2||||0.002|TWO_SIDED|95.0|8.38|49.45||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all Baseline covariates in the analysis set.||49.45|8.38|0.0020
70884019|NCT01675882|141252971|SUPERIORITY||Difference in LS mean|20.0||||0.012|TWO_SIDED|95.0|3.85|40.91||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all Baseline covariates in the analysis set.||40.91|3.85|0.0120
70884020|NCT01675882|141252975|SUPERIORITY||Difference in LS mean|1.2|||<|0.0001|TWO_SIDED|95.0|0.72|1.9||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||1.90|0.72|<0.0001
70884021|NCT01675882|141252975|SUPERIORITY||Difference in LS mean|1.3|||<|0.0001|TWO_SIDED|95.0|0.79|2.01||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||2.01|0.79|<0.0001
70884022|NCT01675882|141252975|SUPERIORITY||Difference in LS mean|2.1|||<|0.0001|TWO_SIDED|95.0|1.39|3.11||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||3.11|1.39|<0.0001
70884023|NCT00735371|141252987|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||95.0|||||ANCOVA|||||||0.0056
70884024|NCT00735371|141252987|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
70884025|NCT00735371|141252987|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
70884026|NCT00735371|141252988|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0235||95.0|||||Cochran-Mantel-Haenszel|||||||0.0235
70884027|NCT00735371|141252988|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
70884028|NCT00735371|141252988|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
70884029|NCT00994448|141252990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.3|STANDARD_ERROR_OF_MEAN|8.6||0.08|TWO_SIDED|95.0|1.8|34.3|||t-test, 2 sided|||t test for mean of days retained in the bupropion versus placebo groups||34.3|1.8|0.08
70884030|NCT01604343|141252991|SUPERIORITY_OR_OTHER||Percentage Difference|28.4|||<|0.001|TWO_SIDED|95.0|22.8|33.8|||Cochran-Mantel-Haenszel|||||33.8|22.8|< 0.001
70963421|NCT02430051|141431447|SUPERIORITY|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
70884031|NCT01604343|141252991|SUPERIORITY_OR_OTHER||Percentage Difference|27.1|||<|0.001|TWO_SIDED|95.0|21.6|32.6|||Cochran-Mantel-Haenszel|||||32.6|21.6|< 0.001
70884032|NCT01604343|141252992|SUPERIORITY_OR_OTHER||||||<|0.001|||||||van der waerden ANOVA|||||||< 0.001
70884033|NCT01604343|141252992|SUPERIORITY_OR_OTHER||||||<|0.001|||||||van der waerden ANOVA|||||||< 0.001
70884034|NCT01604343|141252993|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.226|||<|0.001|TWO_SIDED|95.0|-0.29|-0.17|||ANCOVA|||||-0.17|-0.29|<0.001
70884035|NCT01604343|141252993|SUPERIORITY_OR_OTHER||LS mean difference|-0.256|||<|0.001|TWO_SIDED|95.0|-0.32|-0.2|||ANCOVA|||||-0.20|-0.32|<0.001
70884036|NCT01604343|141252994|SUPERIORITY_OR_OTHER||Percentage Difference|17.8|||<|0.001|TWO_SIDED|95.0|13.1|22.4|||Cochran-Mantel-Haenszel|||||22.4|13.1|< 0.001
70884037|NCT01604343|141252994|SUPERIORITY_OR_OTHER||Percentage Difference|20.8|||<|0.001|TWO_SIDED|95.0|16.1|25.6|||Cochran-Mantel-Haenszel|||||25.6|16.1|< 0.001
70884038|NCT01604343|141252995|SUPERIORITY_OR_OTHER||Percentage Difference|20.5|||<|0.001|TWO_SIDED|95.0|16.4|24.6|||Cochran-Mantel-Haenszel|||||24.6|16.4|< 0.001
70884039|NCT01604343|141252995|SUPERIORITY_OR_OTHER||Percentage Difference|19.9|||<|0.001|TWO_SIDED|95.0|15.8|24.0|||Cochran-Mantel-Haenszel|||||24.0|15.8|< 0.001
70884040|NCT01604343|141252996|SUPERIORITY_OR_OTHER||Percentage Difference|3.6||||0.001|TWO_SIDED|95.0|1.4|5.8|||Cochran-Mantel-Haenszel|||||5.8|1.4|0.001
70884041|NCT01604343|141252996|SUPERIORITY_OR_OTHER||Percentage Difference|7.2|||<|0.001|TWO_SIDED|95.0|4.6|9.8|||Cochran-Mantel-Haenszel|||||9.8|4.6|< 0.001
70884042|NCT00436748|141253027|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Exact|||The null hypothesis for the Darbepoetin Alfa QW group was that the correction proportion (p) ≤ 0.8 ; Th alternative hypothesis was that p \> 0.8. The correction proportion was compared with 0.8 using the exact method to test the null hypothesis at a 1-sided overall significance level of 0.025.||||<0.001
70884043|NCT00436748|141253027|SUPERIORITY_OR_OTHER_LEGACY|||||||0.293|||||||Exact|||The null hypothesis for the Darbepoetin Alfa Q2W group was that the correction proportion (p) ≤ 0.8 ; Th alternative hypothesis was that p \> 0.8. The correction proportion was compared with 0.8 using the exact method to test the null hypothesis at a 1-sided overall significance level of 0.025.||||0.293
70884044|NCT01610791|141253043|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Difference in ALT from Baseline to Week 24||||<0.001
70884045|NCT01610791|141253043|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Difference in AST from Baseline to Week 24||||<0.001
70884046|NCT01610791|141253044|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Diffrence in total cholesterol from baseline to Week 24||||<0.001
70884047|NCT01610791|141253044|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Difference in LDL cholesterol from baseline to Week 24||||<0.001
70884048|NCT04998136|141253079|SUPERIORITY||Treatment difference|-12.99|||<|0.0001|TWO_SIDED|95.0|-15.28|-10.7|||ANCOVA|||Treatment policy Estimand. The primary endpoint was analysed using an analysis of covariance (ANCOVA) model with randomized treatment as factor and baseline body weight as covariate. Analysed data is from in-trial observation period.||-10.70|-15.28|<0.0001
70884049|NCT04998136|141253080|SUPERIORITY||Treatment Difference|-13.4|||<|0.0001|TWO_SIDED|95.0|-15.7|-11.11|||MMRM|||Hypothetical Estimand. The primary endpoint was analysed using mixed model for repeated measurements (MMRM). All responses prior to first discontinuation of treatment (or dose reduction, or initiation of other anti-obesity medication or bariatric surgery) were included in MMRM with randomized treatment as factor and baseline body weight as covariate. Analysed data is from on-treatment observation period.||-11.11|-15.70|<0.0001
70884050|NCT04998136|141253081|SUPERIORITY||Odds Ratio (OR)|88.87|||<|0.0001|TWO_SIDED|95.0|21.96|359.61|||Regression, Logistic|||Treatment policy estimand. The primary endpoint was analysed using a binary logistic regression model with randomized treatment as factor and baseline body weight as covariate. Analysed data is from in-trial period.||359.61|21.96|<0.0001
70884051|NCT04998136|141253082|SUPERIORITY||Odds Ratio (OR)|253.47|||<|0.0001|TWO_SIDED|95.0|38.41|1672.57|||Regression, Logistic|||Hypothetical estimand. MMRM was used with randomized treatment as factor and baseline body weight as covariate. The MMRM was performed on body weight (kg) and individual missing week 44 responses were predicted from the MMRM, each participant was then classified for body weight loss \>= 5% and analysed using a binary logistic regression model with randomized treatment as factor and baseline body weight as covariate. Analysed data is from on-treatment observation period.||1672.57|38.41|<0.0001
70884052|NCT03754959|141253119|OTHER||Ratio|97.9|||||TWO_SIDED|90.0|90.2|106.2|||||Ratio is calculated with Placebo+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||106.2|90.2|
70884053|NCT03754959|141253119|OTHER||Ratio|95.9|||||TWO_SIDED|90.0|89.9|102.4|||||Ratio is calculated with BI 1358894 10 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|||102.4|89.9|
70884054|NCT03754959|141253119|OTHER||Ratio|101.0|||||TWO_SIDED|90.0|96.3|106.1|||||Ratio is calculated with BI 1358894 25 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||106.1|96.3|
70884055|NCT03754959|141253119|OTHER||Ratio|93.7|||||TWO_SIDED|90.0|86.8|101.1|||||Ratio is calculated with BI 1358894 50 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||101.1|86.8|
70884056|NCT03754959|141253119|OTHER||Ratio|93.1|||||TWO_SIDED|90.0|87.3|99.3|||||Ratio is calculated with BI 1358894 100 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||99.3|87.3|
70884057|NCT03754959|141253119|OTHER||Ratio|90.0|||||TWO_SIDED|90.0|83.8|96.7|||||Ratio is calculated with BI 1358894 200 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||96.7|83.8|
70884058|NCT03754959|141253120|OTHER||Ratio|105.7|||||TWO_SIDED|90.0|95.6|116.9|||||Ratio is calculated with Placebo+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||116.9|95.6|
70884059|NCT03754959|141253120|OTHER||Ratio|117.5|||||TWO_SIDED|90.0|106.5|129.6|||||Ratio is calculated with BI 1358894 10 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||129.6|106.5|
70884060|NCT03754959|141253120|OTHER||Ratio|112.6|||||TWO_SIDED|90.0|102.9|123.1|||||Ratio is calculated with BI 1358894 25 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||123.1|102.9|
70884061|NCT03754959|141253120|OTHER||Ratio|110.3|||||TWO_SIDED|90.0|90.1|135.1|||||Ratio is calculated with BI 1358894 50 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||135.1|90.1|
70963422|NCT02430051|141431448|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70884062|NCT03754959|141253120|OTHER||Ratio|96.4|||||TWO_SIDED|90.0|84.5|110.1|||||Ratio is calculated with BI 1358894 100 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||110.1|84.5|
70884063|NCT03754959|141253120|OTHER||Ratio|89.3|||||TWO_SIDED|90.0|74.9|106.4|||||Ratio is calculated with BI 1358894 200 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||106.4|74.9|
70884064|NCT03754959|141253121|OTHER||Ratio|98.3|||||TWO_SIDED|90.0|84.2|114.8|||||Ratio is calculated with Placebo+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||114.8|84.2|
70963423|NCT02430051|141431449|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70963424|NCT02430051|141431450|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70884065|NCT03754959|141253121|OTHER||Ratio|98.0|||||TWO_SIDED|90.0|87.9|109.3|||||Ratio is calculated with BI 1358894 10mg +Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||109.3|87.9|
70884066|NCT03754959|141253121|OTHER||Ratio|117.5|||||TWO_SIDED|90.0|102.6|134.6|||||Ratio is calculated with BI 1358894 25 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||134.6|102.6|
70884067|NCT03754959|141253121|OTHER||Ratio|94.5|||||TWO_SIDED|90.0|85.5|104.4|||||Ratio is calculated with BI 1358894 50 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||104.4|85.5|
70884068|NCT03754959|141253121|OTHER||Ratio|98.2|||||TWO_SIDED|90.0|87.3|99.3|||||Ratio is calculated with BI 1358894 100 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||99.3|87.3|
70884069|NCT03754959|141253121|OTHER||Ratio|98.0|||||TWO_SIDED|90.0|84.3|114.0|||||Ratio is calculated with BI 1358894 200 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||114.0|84.3|
70884070|NCT03754959|141253122|OTHER||Ratio|95.5|||||TWO_SIDED|90.0|81.3|112.1|||||Ratio is calculated with Placebo+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||112.1|81.3|
70884071|NCT03754959|141253122|OTHER||Ratio|105.7|||||TWO_SIDED|90.0|91.5|122.0|||||Ratio is calculated with BI 1358894 10mg +Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||122.0|91.5|
70884072|NCT03754959|141253122|OTHER||Ratio|116.3|||||TWO_SIDED|90.0|90.9|148.7|||||Ratio is calculated with BI 1358894 25 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||148.7|90.9|
70884073|NCT03754959|141253122|OTHER||Ratio|106.8|||||TWO_SIDED|90.0|92.4|123.4|||||Ratio is calculated with BI 1358894 50 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||123.4|92.4|
70884074|NCT03754959|141253122|OTHER||Ratio|83.9|||||TWO_SIDED|90.0|71.2|98.9|||||Ratio is calculated with BI 1358894 100 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||98.9|71.2|
70884075|NCT03754959|141253122|OTHER||Ratio|87.2|||||TWO_SIDED|90.0|73.5|103.5|||||Ratio is calculated with BI 1358894 200 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||103.5|73.5|
70963425|NCT02430051|141431451|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70963426|NCT02430051|141431452|SUPERIORITY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.92
70963427|NCT02430051|141431453|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
70963428|NCT02430051|141431454|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
70884076|NCT00449956|141253128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||||95.0|-1.3|-0.06|||||An analysis of covariance model with a factor for treatment and time-matched baseline as a covariate was used to compute 95% confidence intervals.|||-0.06|-1.30|
70884077|NCT00449956|141253128|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 1.2 mmHg|Mean Difference (Final Values)|0.28||||||95.0|-0.22|0.78|||||An analysis of covariance model with a factor for treatment and time-matched baseline as a covariate was used to compute 95% confidence intervals.|||0.78|-0.22|
70884078|NCT02462967|141253134|SUPERIORITY|||||||1|||||||ANCOVA|||||||1.000
70884079|NCT02462967|141253134|SUPERIORITY|||||||1|||||||ANCOVA|||||||1.000
70884080|NCT02462967|141253135|SUPERIORITY|||||||0.447|||||||ANCOVA|||||||0.447
70884081|NCT02462967|141253135|SUPERIORITY|||||||0.921|||||||ANCOVA|||||||0.921
70884082|NCT02462967|141253136|SUPERIORITY|||||||0.522|||||||ANCOVA|||||||0.522
70884083|NCT02462967|141253136|SUPERIORITY|||||||1|||||||ANCOVA|||||||1.000
70884084|NCT02462967|141253137|SUPERIORITY|||||||0.943|||||||ANCOVA|||||||0.943
70884085|NCT02462967|141253137|SUPERIORITY|||||||0.492|||||||ANCOVA|||||||0.492
70963429|NCT02430051|141431455|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.80
70884086|NCT02462967|141253138|SUPERIORITY|||||||0.832|||||||ANCOVA|||||||0.832
70884087|NCT02462967|141253138|SUPERIORITY|||||||0.558|||||||ANCOVA|||||||0.558
70884088|NCT02462967|141253139|SUPERIORITY|||||||0.362|||||||ANCOVA|||||||0.362
70884089|NCT02462967|141253139|SUPERIORITY|||||||0.602|||||||ANCOVA|||||||0.602
70884090|NCT02462967|141253140|SUPERIORITY|||||||0.633|||||||Chi-squared|||||||0.633
70884091|NCT02462967|141253140|SUPERIORITY|||||||0.814|||||||Chi-squared|||||||0.814
70884092|NCT01988571|141253152|SUPERIORITY|Power described in protocol.|Mean Difference (Net)|0.1608|STANDARD_ERROR_OF_MEAN|0.7787||0.84|TWO_SIDED||||||ANCOVA|Adjusted for multiple imputation of missing data||Linear models adjusting for baseline values and utilized multiple imputation for missing data.||||0.84
70884093|NCT00004412|141253162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.05|TWO_SIDED||||||Fisher Exact|||Percentage of ulcers undergoing partial and complete healing compared at 12 weeks. Mean Ulcer areas were calculated utilizing computerized planimetry, ulcer area tracings, and photography for baseline and 12 weeks and compared between the two study Arms.||||0.05
70884094|NCT00453999|141253166|SUPERIORITY_OR_OTHER|||||||0.306|TWO_SIDED||||||Log Rank|Differences between groups by log-rank statistic stratified by oxygen saturation and duration of illness at randomization, and flu season.||||||0.306
70884095|NCT00453999|141253167|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Sore Throat: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
70884096|NCT00453999|141253167|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Nasal Congestion: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
70884097|NCT00453999|141253167|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Cough: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
70884098|NCT00453999|141253167|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Aches and Pains: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
70884099|NCT00453999|141253167|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Fatigue: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
70884100|NCT00453999|141253167|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Headache: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
70884101|NCT00453999|141253167|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Feeling Feverish: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
70884102|NCT00453999|141253168|SUPERIORITY_OR_OTHER|||||||0.276|TWO_SIDED||||||Log Rank|||||||0.276
70884103|NCT00453999|141253170|SUPERIORITY_OR_OTHER|||||||0.994|TWO_SIDED||||||Log Rank|||||||0.994
70884104|NCT00453999|141253171|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Change from Baseline at 12 hours||||>0.05
70884105|NCT00453999|141253171|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Change from Baseline at 24 hours||||>0.05
70884106|NCT00453999|141253171|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Change from Baseline at 36 hours||||>0.05
70884107|NCT00453999|141253171|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Change from Baseline at 48 hours||||>0.05
70884108|NCT00453999|141253171|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Change from Baseline at 72 hours||||>0.05
70884109|NCT00453999|141253171|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Change from Baseline at 96 hours||||>0.05
70884110|NCT04180020|141253223|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||||||0.94
70884111|NCT02917031|141253248|SUPERIORITY||Mean Difference (Final Values)|-2.595||||0.252|TWO_SIDED|95.0|-7.04|1.85|||ANCOVA|||Change from baseline, saxagliptin versus placebo.||1.850|-7.040|0.252
70884112|NCT02917031|141253249|SUPERIORITY||Mean Difference (Final Values)|-1.631||||0.425|TWO_SIDED|95.0|-5.635|2.373|||ANCOVA|||Saxagliptin: Change from baseline||2.373|-5.635|0.425
70884113|NCT02917031|141253250|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.925|TWO_SIDED|95.0|-1.996|2.197|||ANCOVA|||"Saxagliptin vs Placebo:~Change from baseline"||2.197|-1.996|0.925
70884114|NCT02917031|141253251|SUPERIORITY||Mean Difference (Final Values)|-3.605||||0.105|TWO_SIDED|95.0|-7.97|0.76|||ANCOVA|||Saxagliptin vs placebo: Change from baseline||0.760|-7.970|0.105
70884115|NCT02917031|141253252|SUPERIORITY||Ratio for relative change|0.971||||0.796|TWO_SIDED|95.0|0.777|1.214|||ANCOVA|||Saxagliptin vs placebo: Change from baseline||1.214|0.777|0.796
70884116|NCT00403273|141253264|SUPERIORITY|||||||0.01||||||p-value not adjusted for multiple comparisons; the a priori threshold for statistical significance was \<0.05|t-test, 2 sided|||||||0.01
70884117|NCT00403273|141253265|SUPERIORITY_OR_OTHER||comparison of proportions|0.65|||<|0.05|TWO_SIDED|95.0||||No adjustment for multiple comparisons was made, since we analyzed only one primary outcome. 19 patients per group were needed for 80% power and 24 patients per group for 90% power to detect a difference of 43% in proportion with primary outcome|comparison of proportions|compare proportion of patients with clinically meaningful change in 0-10 VAS pain (at least 2-point reduction on VAS pain) at 2-mths \& all timepoints|we hypothesized a greater proportion with meaningful reduction in pain on 0-10 scale in intervention versus placebo group.|For primary outcome analysis, we compared the proportion of responders with clinically meaningful change \[improvement\] in 0-10 VAS Pain, i.e. those with 2-point reduction in 0-10 VAS pain score at 2-mths, in the 2 groups using comparison of proportions. Proportion of responders were also analyzed at all efficacy timepoints using generalized estimating equation (GEE) modeling. We used GEE for between-group comparisons in secondary outcomes at all efficacy endpoints, adjusted for baseline scores.||||<0.05
70884118|NCT00403273|141253266|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
70884119|NCT00403273|141253267|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
70884120|NCT00403273|141253268|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||||||0.046
70884121|NCT00403273|141253269|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
70884122|NCT00403273|141253270|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
70884123|NCT04041869|141253271|SUPERIORITY||Mean Difference (Final Values)|0.01|||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||In order to test the effect of the intervention on physical activity, linear mixed models examined changes in steps per day from study baseline (week 0) to the end of the active intervention (week 8).||||<0.01
70884124|NCT01852292|141253290|OTHER|Double Criteria for PFS|Cox Proportional Hazard|0.646|||||TWO_SIDED|95.0|0.44|0.94||||||||0.94|0.44|
70884125|NCT01852292|141253291|OTHER|Double criteria for OS|Cox Proportional Hazard|0.72|||||TWO_SIDED|95.0|0.49|1.04||||||||1.04|0.49|
70884126|NCT02586012|141253302|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
70884127|NCT02586012|141253303|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
70884128|NCT02586012|141253304|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
70884129|NCT03240575|141253338|SUPERIORITY||Mean Difference (Net)|0.052|STANDARD_ERROR_OF_MEAN|0.027||0.0543|TWO_SIDED|95.0|-0.001|0.105|||Mixed-effects model repeated measures|Treatment, visit and treatment by visit interaction as fixed effects, and baseline as well as baseline by visit interaction as covariates.||||0.105|-0.001|0.0543
70884130|NCT03240575|141253339|SUPERIORITY||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.027||0.0011|TWO_SIDED|95.0|0.037|0.144|||Mixed-effects model repeated measures|Treatment, visit and treatment by visit interaction as fixed effects, and baseline as well as baseline by visit interaction as covariates.||||0.144|0.037|0.0011
70884131|NCT03240575|141253340|SUPERIORITY||Mean Difference (Net)|0.005|STANDARD_ERROR_OF_MEAN|0.027||0.8593|TWO_SIDED|95.0|-0.048|0.058|||Mixed-effects model repeated measures|Treatment, visit and treatment by visit interaction as fixed effects, and baseline as well as baseline by visit interaction as covariates.||||0.058|-0.048|0.8593
70884132|NCT03240575|141253341|SUPERIORITY||Mean Difference (Net)|0.098|STANDARD_ERROR_OF_MEAN|0.029||0.001|TWO_SIDED|95.0|0.04|0.156|||Mixed-effects model repeated measures|Treatment, visit and treatment by visit interaction as fixed effects, and baseline as well as baseline by visit interaction as covariates.||||0.156|0.040|0.0010
70884133|NCT02431754|141253342|SUPERIORITY_OR_OTHER|||||||0.0937|||||||Normal approximation (Z-test)|||||||0.0937
70884134|NCT02431754|141253343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.1485|TWO_SIDED|95.0|-1.69|0.26|||Mixed Models Analysis|||||0.26|-1.69|0.1485
70884135|NCT02342704|141253369|SUPERIORITY_OR_OTHER|||||||0.126|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||Week 4||||0.1260
70884136|NCT02342704|141253369|SUPERIORITY_OR_OTHER|||||||0.3525|||||||negative binomial regression|p-value is based on negative binomial regression model, adjusted for baseline GD lesion count||Week 4||||0.3525
70963430|NCT02430051|141431456|SUPERIORITY||||||<|0.0001|||||||Multivariate linear regression|Adjusted for autism severity, IQ, dental fear and anxiety, sensory over-responsivity, general anxiety, expressive communication, gender, and age.||||||<0.0001
70884137|NCT02342704|141253369|SUPERIORITY_OR_OTHER|||||||0.0127|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||Week 12||||0.0127
70884138|NCT02342704|141253369|SUPERIORITY_OR_OTHER|||||||0.0299|||||||negative binomial regression|p-value is based on negative binomial regression model, adjusted for baseline GD lesion count||Week 12||||0.0299
70884139|NCT02342704|141253369|SUPERIORITY_OR_OTHER|||||||0.0123|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||Week 24||||0.0123
70884140|NCT02342704|141253369|SUPERIORITY_OR_OTHER|||||||0.0076|||||||negative binomial regression|p-value is based on negative binomial regression model, adjusted for baseline GD lesion count||Week 24||||0.0076
70884141|NCT02342704|141253370|SUPERIORITY_OR_OTHER|||||||0.5318|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||T1 Lesion Volume Change||||0.5318
70884142|NCT02342704|141253370|SUPERIORITY_OR_OTHER|||||||0.0528|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||T2 Lesion Volume Change||||0.0528
70884143|NCT02342704|141253372|SUPERIORITY_OR_OTHER|||||||0.2632|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||||||0.2632
70884144|NCT02347527|141253381|SUPERIORITY|||||||0.038|||||||ANOVA|||||||0.038
70884145|NCT02347527|141253381|SUPERIORITY|||||||0.036|||||||ANOVA|||||||0.036
70884146|NCT02347527|141253382|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.010
70884147|NCT02347527|141253383|OTHER|||||||0.04|||||||Pearson's correlation|||Relationship between change in high-calorie food ratings and subsequent food intake (kcals).||||0.040
70884148|NCT02347527|141253383|OTHER|||||||0.92|||||||Pearson's correlation|||Relationship between change in high-calorie food ratings and subsequent food intake (kcals).||||0.92
70884149|NCT01632891|141253384|SUPERIORITY|Test used alpha level of 0.05||||||1|||||||Fisher Exact|||Compare proportions of Pf SCP clearance between treatment arms||||1.00
70884150|NCT02624284|141253452|SUPERIORITY|Analysis: Multiple regression predicting main effects of dose on latency to smoke. Age, sex, race, nicotine dependence, and pre-session craving for negative affect relief (QSU-B Factor 2) were included as covariates.||||||0.94|||||||Regression, Linear|||||||0.94
70884151|NCT02624284|141253453|SUPERIORITY|Analysis: Multiple regression predicting main effects of dose on number of cigarettes smoked. Age, sex, race, nicotine dependence, and pre-session craving for negative affect relief (QSU-B Factor 2) were included as covariates.||||||0.53|||||||Regression, Linear|||||||0.53
70884152|NCT02624284|141253455|SUPERIORITY|Analysis: Multiple regression predicting main effects of dose on days of abstinence. Age, sex, race and nicotine dependence were included as covariates.||||||0.78|||||||Regression, Linear|||||||0.78
70884153|NCT00357370|141253564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.1898|||TWO_SIDED|95.0|-1.08|-0.32|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.|||-0.32|-1.08|
70884154|NCT00357370|141253564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.1903|||TWO_SIDED|95.0|-1.16|-0.4|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.|||-0.40|-1.16|
70884155|NCT00357370|141253565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.44|STANDARD_ERROR_OF_MEAN|11.4753|||TWO_SIDED|95.0|-38.37|7.48|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.|||7.48|-38.37|
70884156|NCT00357370|141253565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.44|STANDARD_ERROR_OF_MEAN|11.4574|||TWO_SIDED|95.0|-50.33|-4.55|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.|||-4.55|-50.33|
70884157|NCT00357370|141253569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.05|STANDARD_ERROR_OF_MEAN|3.8302|||TWO_SIDED|95.0|-10.69|4.6|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.|||4.60|-10.69|
70884158|NCT00357370|141253569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.52|STANDARD_ERROR_OF_MEAN|3.8291|||TWO_SIDED|95.0|-10.17|5.12|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.|||5.12|-10.17|
70884159|NCT00404352|141253589|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.||||||<0.001
70884160|NCT00404352|141253589|SUPERIORITY_OR_OTHER|||||||0.008|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.||||||0.008
70884161|NCT00404352|141253589|SUPERIORITY_OR_OTHER|||||||0.009|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.||||||0.009
70884162|NCT00404352|141253590|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.||||||<0.001
70884163|NCT00404352|141253590|SUPERIORITY_OR_OTHER|||||||0.002|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.||||||0.002
70884164|NCT00404352|141253590|SUPERIORITY_OR_OTHER|||||||0.774|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.||||||0.774
70884165|NCT03663283|141253596|SUPERIORITY|||||||0.0197|||||||Wilcoxon (Mann-Whitney)|||||||.0197
70884166|NCT03663283|141253597|SUPERIORITY|||||||0.584|||||||Wilcoxon (Mann-Whitney)|||72 hours||||0.584
70884167|NCT03663283|141253597|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||3 weeks||||.5800
70884168|NCT03663283|141253598|SUPERIORITY|||||||0.11|||||||Log Rank|||||||0.11
70884169|NCT03663283|141253599|SUPERIORITY|||||||0.7018|||||||Wilcoxon (Mann-Whitney)|||72 hours||||.7018
70884170|NCT03663283|141253599|SUPERIORITY|||||||0.5327|||||||Wilcoxon (Mann-Whitney)|||Week 3||||.5327
70963431|NCT02430051|141431457|SUPERIORITY|||||||0.61|||||||General linear mixed model|||||||0.61
70963432|NCT02019420|141431466|NON_INFERIORITY|Difference in ITT all-cause mortality (linezolid - tedizolid). Noninferiority is declared when the lower bound of the 95% CI \> -10.|Difference in all-cause mortality|-1.8|||||TWO_SIDED|95.0|-8.2|4.7|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||4.7|-8.2|
70884171|NCT02346136|141253600|SUPERIORITY||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.25||0.62|TWO_SIDED|95.0|-0.62|0.37||Tested as two-tailed p\<0.025 to accommodate two co-primary outcomes|Mixed Models Analysis|||||0.37|-0.62|0.62
70884172|NCT02346136|141253601|SUPERIORITY||Risk Ratio (RR)|0.535||||0.194|TWO_SIDED|95.0|0.182|1.57|||Mixed Models Analysis|Mixed model Poisson reg with fixed effects of age, baseline SPPB, baseline CES-D, and falls in prev year and random intercept and trt by site pair|Numerator of risk ratio is the rate among participants at sites receiving Tai Chi. Denominator of risk ratio is the rate among participants at sites receiving Health Education.|||1.57|0.182|0.194
70884173|NCT02346136|141253602|SUPERIORITY||Mean Difference (Net)|-0.65|STANDARD_ERROR_OF_MEAN|0.94||0.5|TWO_SIDED|95.0|-2.53|1.24|||Mixed Models Analysis|||||1.24|-2.53|.50
70884174|NCT02346136|141253603|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.85|TWO_SIDED|95.0|-0.04|0.05|||Mixed Models Analysis|||Gait NW velocity variable||.05|-.04|.85
70884175|NCT02346136|141253603|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.26|TWO_SIDED|95.0|-0.02|0.06|||Mixed Models Analysis|||Gait DT velocity variable||.06|-.02|.26
70884176|NCT02346136|141253604|SUPERIORITY||Mean Difference (Net)|-0.004|STANDARD_ERROR_OF_MEAN|0.02||0.84|TWO_SIDED|95.0|-0.04|0.03|||Mixed Models Analysis|||||0.03|-0.04|0.84
70884177|NCT02346136|141253605|SUPERIORITY||Mean Difference (Net)|0.81|STANDARD_ERROR_OF_MEAN|0.71||0.26|TWO_SIDED|95.0|-0.61|2.22|||Mixed Models Analysis|||||2.22|-0.61|.26
70884178|NCT02346136|141253606|SUPERIORITY||Median Difference (Net)|0.72|STANDARD_ERROR_OF_MEAN|7.29||0.92|TWO_SIDED|95.0|-13.9|15.3|||Mixed Models Analysis|||||15.3|-13.9|.92
70884179|NCT02346136|141253607|SUPERIORITY||Median Difference (Net)|1.36|STANDARD_ERROR_OF_MEAN|9.28||0.88|TWO_SIDED|95.0|-17.2|19.9|||Mixed Models Analysis|||||19.9|-17.2|.88
70884180|NCT02346136|141253608|SUPERIORITY||Mean Difference (Net)|0.85|STANDARD_ERROR_OF_MEAN|1.43||0.55|TWO_SIDED|95.0|-2.0|3.71|||Mixed Models Analysis|||Physical component score||3.71|-2.00|.55
70884181|NCT02346136|141253608|SUPERIORITY||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|1.66||0.51|TWO_SIDED|95.0|-4.41|2.21|||Mixed Models Analysis|||Mental component score||2.21|-4.41|.51
70884182|NCT02346136|141253609|SUPERIORITY||Median Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|1.0||0.69|TWO_SIDED|95.0|-1.6|2.41|||Mixed Models Analysis|||||2.41|-1.60|.69
70884183|NCT02346136|141253610|SUPERIORITY||Mean Difference (Net)|2.14|STANDARD_ERROR_OF_MEAN|2.56||0.41|TWO_SIDED|95.0|-2.98|7.26||to accommodate two co-primary outcomes|Mixed Models Analysis|||||7.26|-2.98|0.41
70884184|NCT02346136|141253612|SUPERIORITY||Risk Ratio (RR)|0.476||||0.06|TWO_SIDED|95.0|0.216|1.05|||Mixed Models Analysis|Mixed model Poisson reg with fixed effects of age, baseline SPPB, baseline CES-D, and falls in prev year and random intercept and trt by site pair|Numerator of risk ratio is the rate among participants at sites receiving Tai Chi. Denominator of risk ratio is the rate among participants at sites receiving Health Education.|||1.05|0.216|0.060
70884185|NCT02346136|141253613|SUPERIORITY||Mean Difference (Net)|1.27|STANDARD_ERROR_OF_MEAN|0.81||0.13|TWO_SIDED|95.0|-0.4|2.94|||Mixed Models Analysis|||||2.94|-0.40|0.13
70884186|NCT01052545|141253615|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Descriptive statistics were used to estimate the incidence rates per 1,000 bed-days and 95% confidence intervals (CI) for urine cultures ordered, ASB overtreatment and CAUTI under-treatment in each study period.|Regression, Logistic|to test whether there was a significant difference in monthly urine cultures ordered between the two study sites over time.||||||<0.05
70884187|NCT01052545|141253621|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||We used χ2 test, Fisher's exact test and one-way ANOVA to determine if patient-level covariates differed between the baseline, intervention and maintenance periods at each study site.|Regression, Logistic|||||||<0.05
70884188|NCT04120610|141253626|OTHER||Correlation|0.26|||||TWO_SIDED|95.0|0.1|0.41||||||Descriptive analysis of endpoint with no hypothesis.||0.41|0.10|
70884189|NCT04120610|141253627|OTHER||Correlation|-0.26|||||TWO_SIDED|95.0|-0.46|-0.03||||||Correlation of change in acceleration time and ABI. Descriptive analysis of endpoint with no hypothesis.||-0.03|-0.46|
70884190|NCT04120610|141253627|OTHER||Correlation|-0.33|||||TWO_SIDED|95.0|-0.51|-0.12||||||Correlation of change in acceleration time and ABI. Descriptive analysis of endpoint with no hypothesis.||-0.12|-0.51|
70884191|NCT04120610|141253627|OTHER||Correlation|-0.13|||||TWO_SIDED|95.0|-0.38|0.14||||||Correlation of change in acceleration time and ABI. Descriptive analysis of endpoint with no hypothesis.||0.14|-0.38|
70884192|NCT04120610|141253628|OTHER||Correlation|-0.34|||||TWO_SIDED|95.0|-0.52|-0.12||||||Correlation of change in acceleration time and TBI. Descriptive analysis of endpoint with no hypothesis.||-0.12|-0.52|
70884193|NCT04120610|141253628|OTHER||Correlation|-0.35|||||TWO_SIDED|95.0|-0.52|-0.15||||||Correlation of change in acceleration time and TBI. Descriptive analysis of endpoint with no hypothesis.||-0.15|-0.52|
70884194|NCT04120610|141253628|OTHER||Correlation|-0.24|||||TWO_SIDED|95.0|-0.47|0.02||||||Correlation of change in acceleration time and TBI. Descriptive analysis of endpoint with no hypothesis.||0.02|-0.47|
70884195|NCT04120610|141253629|OTHER||Correlation|0.15|||||TWO_SIDED|95.0|-0.08|0.36||||||Correlation of change in acceleration time and Rutherford Classification. Descriptive analysis of endpoint with no hypothesis.||0.36|-0.08|
70884196|NCT04120610|141253629|OTHER||Correlation|0.19|||||TWO_SIDED|95.0|-0.02|0.39||||||Correlation of change in acceleration time and Rutherford Classification. Descriptive analysis of endpoint with no hypothesis.||0.39|-0.02|
70884197|NCT04120610|141253629|OTHER||Correlation|0.24|||||TWO_SIDED|95.0|-0.02|0.47||||||Correlation of change in acceleration time and Rutherford Classification. Descriptive analysis of endpoint with no hypothesis.||0.47|-0.02|
70884198|NCT01465464|141253678|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.435|TWO_SIDED|95.0|0.878|1.352|||Log Rank|||||1.352|0.878|0.435
70884199|NCT00544076|141253684|EQUIVALENCE|The equivalence margin that would be possible to detect (had the protocol reached intended accrual) was 20%,|||||>|0.1||||||no adjustments were made.|Fisher Exact|||||||>0.1
70884200|NCT00544076|141253685|OTHER||||||>|0.1||||||no adjustments done|Chi-squared|no adjustments||compare percentage of patients potent at 6 and 18 months across pairs of treatment arms (arm I vs arm II, arm I vs arm III, arm II vs arm III)||||>0.1
70884201|NCT00544076|141253686|OTHER||||||>|0.2||||||no adjustments done.|ANOVA|||||||>0.2
70884202|NCT00544076|141253687|OTHER||Mean Difference (Final Values)|0.08||||0.08|TWO_SIDED|||||no adjustments|ANOVA|no adjustments for df||"ANOVA test to compare difference of penile length (from baseline to month 18) across arms.~calculations are underpowered, as study did not accrue or retain patients as intended, and many patients declined to have measurements taken."||||0.08
70963433|NCT02019420|141431467|OTHER|Difference in mITT all-cause mortality (linezolid - tedizolid)|Difference in all-cause mortality|-1.6|||||TWO_SIDED|95.0|-10.3|7.1|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||7.1|-10.3|
70884203|NCT01554618|141253688|SUPERIORITY||LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.33||0.012|TWO_SIDED|95.0|-1.51|-0.19|||Mixed Models Analysis||Exenatide versus Placebo|Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, and treatment group by visit interaction, baseline HbA1c value (continuous) and baseline HbA1c by visit interaction as fixed effects, using an unstructured covariance matrix.||-0.19|-1.51|0.012
70884204|NCT01554618|141253691|SUPERIORITY||LS Mean Difference|-21.6|STANDARD_ERROR_OF_MEAN|13.7||0.119|TWO_SIDED|95.0|-49.0|5.7|||Mixed Models Analysis||Exenatide versus Placebo|Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, and treatment group by visit interaction, baseline fasting plasma glucose value, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline fasting plasma glucose by visit interaction as fixed effects, using an unstructured covariance matrix.||5.7|-49.0|0.119
70963434|NCT02019420|141431468|OTHER|Difference in ITT clinical success (tedizolid - linezolid)|Difference in clinical success|-7.6|||||TWO_SIDED|95.0|-14.7|-0.5|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||-0.5|-14.7|
70884205|NCT01554618|141253692|SUPERIORITY||LS Mean Difference|-1.22|STANDARD_ERROR_OF_MEAN|1.189||0.307|TWO_SIDED|95.0|-3.59|1.15|||Mixed Models Analysis||Exenatide versus Placebo|Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, and treatment group by visit interaction, baseline body weight, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline body weight by visit interaction as fixed effects, using an unstructured covariance matrix.||1.15|-3.59|0.307
70884206|NCT01554618|141253693|SUPERIORITY||LS Mean Difference|94.9|STANDARD_ERROR_OF_MEAN|95.26||0.323|TWO_SIDED|95.0|-95.6|285.5|||Mixed Models Analysis||Exenatide versus Placebo|Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, treatment group by visit interaction, baseline fasting insulin, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline fasting insulin by visit interaction as fixed effects, using an unstructured covariance matrix.||285.5|-95.6|0.323
70884207|NCT01554618|141253694|SUPERIORITY||Difference|14.8||||0.077|TWO_SIDED|95.0|1.9|27.7|||Cochran-Mantel-Haenszel||Exenatide versus Placebo. Difference was the risk difference of the 2 proportions.|"Treatment difference in HbA1c \< 6.5%:~Treatment group comparison was based on CMH test stratified by screening HbA1c (\<9.0% or \>=9.0%). P-value was from the general association statistic."||27.7|1.9|0.077
70884208|NCT01554618|141253694|SUPERIORITY||Difference|14.8||||0.077|TWO_SIDED|95.0|1.9|27.7|||Cochran-Mantel-Haenszel||Exenatide versus Placebo. Difference was the risk difference of the 2 proportions.|"Treatment difference in HbA1c ≤ 6.5%:~Treatment group comparison was based on CMH test stratified by screening HbA1c (\<9.0% or \>=9.0%). P-value was from the general association statistic."||27.7|1.9|0.077
70884209|NCT01554618|141253694|SUPERIORITY||Difference|22.7||||0.02|TWO_SIDED|95.0|6.5|39.0|||Cochran-Mantel-Haenszel||Exenatide versus Placebo. Difference was the risk difference of the 2 proportions.|"Treatment difference in HbA1c \< 7.0%:~Treatment group comparison was based on CMH test stratified by screening HbA1c (\<9.0% or \>=9.0%). P-value was from the general association statistic."||39.0|6.5|0.020
70884210|NCT01554618|141253696|SUPERIORITY||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|2.61||0.284|TWO_SIDED|95.0|-8.0|2.4|||Mixed Models Analysis||Exenatide versus Placebo|"Treatment difference in SBP:~Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, treatment group by visit interaction, baseline SBP, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline SBP by visit interaction as fixed effects, using an unstructured covariance matrix."||2.4|-8.0|0.284
70884211|NCT01554618|141253696|SUPERIORITY||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|1.77||0.376|TWO_SIDED|95.0|-2.0|5.1|||Mixed Models Analysis||Exenatide versus Placebo|"Treatment difference in DBP:~Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, treatment group by visit interaction, baseline DBP, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline DBP by visit interaction as fixed effects, using an unstructured covariance matrix."||5.1|-2.0|0.376
70884212|NCT01554618|141253698|SUPERIORITY||LS Mean Difference|90.37|STANDARD_ERROR_OF_MEAN|69.207||0.211|TWO_SIDED|95.0|-57.27|238.0|||Mixed Models Analysis||Exenatide versus Placebo|"Treatment difference in HOMA-B:~Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, treatment group by visit interaction, baseline HOMA-B, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline HOMA-B by visit interaction as fixed effects, using an unstructured covariance matrix."||238.00|-57.27|0.211
70884213|NCT01554618|141253698|SUPERIORITY||LS Mean Difference|-6.75|STANDARD_ERROR_OF_MEAN|6.173||0.289|TWO_SIDED|95.0|-19.8|6.29|||Mixed Models Analysis||Exenatide versus Placebo|"Treatment difference in HOMA-S:~Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, treatment group by visit interaction, baseline HOMA-S, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline HOMA-S by visit interaction as fixed effects, using an unstructured covariance matrix."||6.29|-19.80|0.289
70884214|NCT01495585|141253786|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 2 sided|||Student t-test was used on the change in serum log HDV RNA after 28 days of therapy with lonafarnib.||||0.03
70884215|NCT01495585|141253786|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Student t-test was used on the change in serum log HDV RNA after 28 days of therapy with lonafarnib.||||<0.0001
70884216|NCT01495585|141253787|SUPERIORITY_OR_OTHER|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
70884217|NCT01495585|141253787|SUPERIORITY_OR_OTHER|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.6
70884218|NCT01696435|141253864|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.62|TWO_SIDED|95.0|0.87|1.09||P-value was not adjusted for multiple comparisons. A priori, two-sided tests with an alpha level of 0.025 were used to account for the 2 co-primary outcomes (depression event and mood scores).|Regression, Cox||Active treatment vs. Placebo comparison|||1.09|.87|0.62
70884219|NCT01696435|141253864|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.03|TWO_SIDED|95.0|1.01|1.26||P-value was not adjusted for multiple comparisons. A priori, two-sided tests with an alpha level of 0.025 were used to account for the 2 co-primary outcomes (depression event and mood scores).|Regression, Cox||Active treatment vs. Placebo comparison|||1.26|1.01|0.03
70884220|NCT01696435|141253865|SUPERIORITY||Mean Difference (Net)|0.01|||||TWO_SIDED|95.0|-0.04|0.05|||Mixed Models Analysis|||Test of whether the mean difference in change comparing the treatment groups is different than zero. See full SAP for all details.||0.05|-0.04|
70884221|NCT01696435|141253865|SUPERIORITY||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.01|0.07|||Mixed Models Analysis|||Test of whether the mean difference in change comparing the treatment groups is different than zero. See full SAP for all details.||0.07|-0.01|
70884222|NCT01696435|141253866|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.88|TWO_SIDED|95.0|0.87|1.13||P-value not adjusted for multiple comparisons. This outcome was not a pre-specified primary outcome and results are to be interpreted with caution.|Regression, Cox||Active treatment vs. Placebo comparison|||1.13|0.87|0.88
70884223|NCT01696435|141253866|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.02|TWO_SIDED|95.0|1.03|1.33||P-value not adjusted for multiple comparisons. This outcome was not a pre-specified primary outcome and results are to be interpreted with caution.|Regression, Cox||Active treatment vs. Placebo comparison|||1.33|1.03|0.02
70963435|NCT02019420|141431469|OTHER|Difference in CE clinical success (tedizolid - linezolid)|Difference in clinical success|-6.5|||||TWO_SIDED|95.0|-15.1|2.1|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||2.1|-15.1|
70963436|NCT02019420|141431470|OTHER|Difference in MSSA mITT all-cause mortality (linezolid - tedizolid)|Difference in all-cause mortality|-1.5|||||TWO_SIDED|95.0|-12.5|9.5|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||9.5|-12.5|
70884224|NCT01696435|141253867|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.67|TWO_SIDED|95.0|0.76|1.19|||Regression, Cox||Active treatment vs. Placebo comparison|P-value not adjusted for multiple comparisons. This outcome was not a pre-specified primary outcome and results are to be interpreted with caution.||1.19|0.76|0.67
70884225|NCT01696435|141253867|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.88|TWO_SIDED|95.0|0.82|1.27|||Regression, Cox||Active treatment vs. Placebo comparison|P-value not adjusted for multiple comparisons. This outcome was not a pre-specified primary outcome and results are to be interpreted with caution.||1.27|0.82|0.88
70884226|NCT02223767|141253939|SUPERIORITY|||||||0.025|||||||t-test, 1 sided|||||||0.025
70884227|NCT02223767|141253940|SUPERIORITY|||||||0.08|||||||t-test, 1 sided|||||||0.08
70884228|NCT02633956|141253958|OTHER|Estimation|Least Square Mean Difference|13.79|STANDARD_ERROR_OF_MEAN|5.75|||TWO_SIDED|95.0|2.28|25.3||||||||25.30|2.28|
70884229|NCT02633956|141253958|OTHER|Estimation|Least Square Mean Difference|9.06|STANDARD_ERROR_OF_MEAN|5.61|||TWO_SIDED|95.0|-2.18|20.3||||||||20.30|-2.18|
70884230|NCT02633956|141253958|OTHER|Estimation|Least Square Mean Difference|20.13|STANDARD_ERROR_OF_MEAN|6.39|||TWO_SIDED|95.0|7.33|32.92||||||||32.92|7.33|
70884231|NCT02633956|141253959|OTHER|Estimation|Least Square Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|0.07|0.75||||||||0.75|0.07|
70884232|NCT02633956|141253959|OTHER|Estimation|Least Square Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-0.25|0.42||||||||0.42|-0.25|
70884233|NCT02633956|141253959|OTHER|Estimation|Least Square Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|0.14|0.89||||||||0.89|0.14|
70884234|NCT02633956|141253960|OTHER|Estimation|Least Square Mean Difference|103.61|STANDARD_ERROR_OF_MEAN|69.51|||TWO_SIDED|95.0|-35.58|242.81||||||||242.81|-35.58|
70884235|NCT02633956|141253960|OTHER|Estimation|Least Square Mean Difference|114.8|STANDARD_ERROR_OF_MEAN|68.08|||TWO_SIDED|95.0|-21.53|251.13||||||||251.13|-21.53|
70884236|NCT02633956|141253960|OTHER|Estimation|Least Square Mean Difference|215.05|STANDARD_ERROR_OF_MEAN|79.51|||TWO_SIDED|95.0|55.84|374.26||||||||374.26|55.84|
70884237|NCT01166594|141253961|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70884238|NCT04206293|141253969|SUPERIORITY||Least Squares (LS) Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.9||0.0736|TWO_SIDED|95.0|-0.2|3.6|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||3.6|-0.2|0.0736
70884239|NCT04206293|141253969|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.0||0.5259|TWO_SIDED|95.0|-1.5|2.8|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||2.8|-1.5|0.5259
70963437|NCT02019420|141431471|OTHER|Difference in MRSA mITT all-cause mortality (linezolid - tedizolid)|Difference in all-cause mortality|3.1|||||TWO_SIDED|95.0|-12.8|18.9|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||18.9|-12.8|
70963438|NCT02019420|141431472|OTHER|Difference in mITT favorable response (tedizolid - linezolid)|Difference in clinical success|-13.1|||||TWO_SIDED|95.0|-21.7|-4.5|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||-4.5|-21.7|
70963439|NCT02019420|141431473|OTHER|Difference in ME-1 favorable response (tedizolid - linezolid)|Difference in clinical success|-13.1|||||TWO_SIDED|95.0|-21.7|-4.5|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||-4.5|-21.7|
70963440|NCT02019420|141431474|OTHER|Difference in mITT favorable response (tedizolid - linezolid)|Difference in clinical success|-12.5|||||TWO_SIDED|95.0|-21.5|-3.5|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||-3.5|-21.5|
70963441|NCT02019420|141431475|OTHER|Difference in ME-2 favorable response (tedizolid - linezolid)|Difference in clinical success|-13.7|||||TWO_SIDED|95.0|-26.2|-1.2|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||-1.2|-26.2|
70963442|NCT04722250|141431478|NON_INFERIORITY|The endpoint is designed to test whether the Medtronic SE TAV is non-inferior to Edwards BE TAV in the composite event rate of all-cause mortality, disabling stroke or heart failure rehospitalization at 12 months post-procedure with an absolute non-inferiority margin of 8.0%.|Risk Difference (RD)|-1.2|||<|0.001|TWO_SIDED|90.0|-4.9|2.5|||z-test on Kaplan-Meier percentages|||||2.5|-4.9|<0.001
70963443|NCT04722250|141431479|SUPERIORITY||Risk Difference (RD)|-32.2|||<|0.001|TWO_SIDED|95.0|-38.7|-25.6|||z-test on Kaplan-Meier percentages|||||-25.6|-38.7|<0.001
70963444|NCT02554903|141431499|SUPERIORITY||Geometric Mean Ratio|0.7393||||0.0158|TWO_SIDED|95.0|0.5798|0.9426|||ANCOVA|||||0.9426|0.5798|0.0158
70963445|NCT03739437|141431574|SUPERIORITY|||||||0.384|||||||Chi-squared|||||||0.384
70963446|NCT03951220|141431625|SUPERIORITY|||||||0.7343|||||||ANOVA|||||||0.7343
70884240|NCT04206293|141253970|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.2||0.8848|TWO_SIDED|95.0|-2.8|2.4|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||2.4|-2.8|0.8848
70963447|NCT03951220|141431626|OTHER|Correlation|Spearman (r)|0.39||||0.0445|TWO_SIDED|95.0|0.0|0.68|||Spearman's rank correlation coeffcieitn|||||0.68|0.00|0.0445
70963448|NCT03951220|141431627|SUPERIORITY|||||||0.0079||||||Dunn's multiple comparisons test|Kruskal-Wallis|||For baseline P1NP||||0.0079
70963449|NCT03951220|141431627|SUPERIORITY|||||||0.0482||||||Dunn's multiple comparison test|ANOVA|||For baseline sclerostin||||0.0482
70963450|NCT03951220|141431638|OTHER|||||||0.015|||||||Fisher-Freeman-Halton exact test|||||||0.015
70963451|NCT03951220|141431641|OTHER|||||||0.007|||||||Mann-Whitney test|||||||0.007
70963452|NCT02564926|141431673|OTHER||LS mean difference (kg)|-2.6|||<|0.001|TWO_SIDED|95.0|-3.346|-1.819|||ANCOVA|||||-1.819|-3.346|<0.001
70884241|NCT04206293|141253970|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.8||0.9505|TWO_SIDED|95.0|-1.8|1.7|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||1.7|-1.8|0.9505
70963453|NCT02564926|141431674|OTHER||LS mean difference (%)|-0.46||||0.014|TWO_SIDED|95.0|-0.821|-0.094|||Mixed Models Analysis|||||-0.094|-0.821|0.014
70963454|NCT02564926|141431675|OTHER||Odds Ratio (OR)|1.45||||0.343|TWO_SIDED|95.0|0.673|3.113|||Regression, Logistic|||||3.113|0.673|0.343
70963455|NCT02564926|141431676|OTHER||LS mean difference (mg/dL)|-18.25||||0.006|TWO_SIDED|95.0|-31.14|-5.351|||Mixed Models Analysis|||||-5.351|-31.140|0.006
70963456|NCT02564926|141431677|OTHER||LS mean difference (kg)|-3.7|||<|0.001|TWO_SIDED|95.0|-4.667|-2.631|||Mixed Models Analysis|||||-2.631|-4.667|<0.001
70963457|NCT02564926|141431678|OTHER||LS mean difference (cm)|-2.21||||0.006|TWO_SIDED|95.0|-3.785|-0.635|||Mixed Models Analysis|||||-0.635|-3.785|0.006
70963458|NCT02564926|141431679|OTHER||LS mean difference (kg/m2)|-1.37|||<|0.001|TWO_SIDED|95.0|-1.742|-0.99|||Mixed Models Analysis|||||-0.990|-1.742|<0.001
70963459|NCT02564926|141431680|OTHER||LS mean difference (mmHg)|-6.81||||0.002|TWO_SIDED|95.0|-10.969|-2.641|||Mixed Models Analysis|||||-2.641|-10.969|0.002
70963460|NCT02564926|141431681|OTHER||LS mean difference (mmHg)|-2.61||||0.11|TWO_SIDED|95.0|-5.829|0.6|||Mixed Models Analysis|||||0.600|-5.829|0.110
70963461|NCT02564926|141431682|OTHER||LS mean difference (cm2)|-17.55||||0.002|TWO_SIDED|95.0|-28.603|-6.489|||ANCOVA|||||-6.489|-28.603|0.002
70963462|NCT02564926|141431683|OTHER||LS mean difference (cm2)|-18.39|||<|0.001|TWO_SIDED|95.0|-27.561|-9.218|||ANCOVA|||||-9.218|-27.561|<0.001
70884242|NCT04206293|141253971|SUPERIORITY||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|0.6||0.0007|TWO_SIDED|95.0|1.4|4.0|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||4.0|1.4|0.0007
70963463|NCT02564926|141431684|OTHER||LS mean difference|-0.03||||0.503|TWO_SIDED|95.0|-0.127|0.063|||ANCOVA|||||0.063|-0.127|0.503
70963464|NCT02564926|141431685|OTHER||LS mean difference|-1.3|||<|0.001|TWO_SIDED|95.0|-1.992|-0.54|||ANCOVA|||||-0.540|-1.992|<0.001
70963465|NCT02564926|141431686|OTHER||LS mean difference (ng/mL)|657.71||||0.044|TWO_SIDED|95.0|18.325|1297.101|||ANCOVA|||||1297.101|18.325|0.044
70963466|NCT02564926|141431687|OTHER||LS mean difference (mg/L)|-0.12||||0.756|TWO_SIDED|95.0|-0.858|0.625|||ANCOVA|||||0.625|-0.858|0.756
70963467|NCT02564926|141431688|OTHER||LS mean difference (%)|-1.94|||<|0.001|TWO_SIDED|95.0|-2.807|-1.082|||ANCOVA|||||-1.082|-2.807|<0.001
70963468|NCT02038920|141431724|SUPERIORITY||Odds Ratio (OR)|1.8||||0.1448|TWO_SIDED|95.0|0.816|3.958|||Cochran-Mantel-Haenszel||MLN0002 group/placebo group. Cochran-Mantel-Haenszel (CMH) test was used for analysis. Prior tumor necrosis factor alpha (TNFα) antagonist use (yes/no) was used as stratification factor.|||3.958|0.816|0.1448
70963469|NCT02038920|141431725|SUPERIORITY||Odds Ratio (OR)|3.57||||0.1779|TWO_SIDED|95.0|0.532|23.953|||Pearson's Chi-square Test||MLN0002 group/placebo group|||23.953|0.532|0.1779
70963470|NCT02038920|141431731|SUPERIORITY||Odds Ratio (OR)|1.83||||0.1963|TWO_SIDED|95.0|0.72|4.673|||Cochran-Mantel-Haenszel||MLN0002 group/placebo group. Cochran-Mantel-Haenszel (CMH) test was used for analysis. Prior tumor necrosis factor alpha (TNFα) antagonist use (yes/no) was used as stratification factor.|||4.673|0.720|0.1963
70884243|NCT04206293|141253971|SUPERIORITY||LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|0.7||0.0033|TWO_SIDED|95.0|0.9|3.9|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||3.9|0.9|0.0033
70884244|NCT04206293|141253972|SUPERIORITY||LS Mean Difference|-0.095|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|-0.119|-0.07|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Uf: Change from Baseline to Day 28||-0.070|-0.119|<0.0001
70884245|NCT04206293|141253972|SUPERIORITY||LS Mean Difference|-0.071|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|-0.094|-0.048|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Uf: Change from Baseline to Day 84||-0.048|-0.094|<0.0001
70884246|NCT04206293|141253972|SUPERIORITY||LS Mean Difference|-0.089|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|-0.116|-0.061|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ue: Change from Baseline to Day 28||-0.061|-0.116|<0.0001
70884247|NCT04206293|141253972|SUPERIORITY||LS Mean Difference|-0.081|STANDARD_ERROR_OF_MEAN|0.009|<|0.0001|TWO_SIDED|95.0|-0.102|-0.061|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ue: Change from Baseline to Day 84||-0.061|-0.102|<0.0001
70884248|NCT04206293|141253972|SUPERIORITY||LS Mean Difference|-0.079|STANDARD_ERROR_OF_MEAN|0.018||0.0003||95.0|-0.116|-0.041|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ur: Change from Baseline to Day 28||-0.041|-0.116|0.0003
70884249|NCT04206293|141253972|SUPERIORITY||LS Mean Difference|-0.074|STANDARD_ERROR_OF_MEAN|0.013||0.0001|TWO_SIDED|95.0|-0.103|-0.044|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ur: Change from Baseline to Day 84||-0.044|-0.103|0.0001
70884250|NCT04206293|141253972|SUPERIORITY||LS Mean Difference|-0.081|STANDARD_ERROR_OF_MEAN|0.017||0.0002|TWO_SIDED|95.0|-0.117|-0.045|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ua: Change from Baseline to Day 28||-0.045|-0.117|0.0002
70884251|NCT04206293|141253972|SUPERIORITY||LS Mean Difference|-0.077|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|-0.103|-0.052|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ua: Change from Baseline to Day 84||-0.052|-0.103|<0.0001
70884252|NCT04206293|141253973|SUPERIORITY||LS Mean Difference|-0.008|STANDARD_ERROR_OF_MEAN|0.014||0.5786|TWO_SIDED|95.0|-0.038|0.022|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Q1: Change from Baseline to Day 28||0.022|-0.038|0.5786
70884253|NCT04206293|141253973|SUPERIORITY||LS Mean Difference|-0.023|STANDARD_ERROR_OF_MEAN|0.012||0.069|TWO_SIDED|95.0|-0.049|0.002|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Q1: Change from Baseline to Day 84||0.002|-0.049|0.0690
70884254|NCT04206293|141253973|SUPERIORITY||LS Mean Difference|-0.021|STANDARD_ERROR_OF_MEAN|0.016||0.1934|TWO_SIDED|95.0|-0.054|0.012|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Q2: Change from Baseline to Day 28||0.012|-0.054|0.1934
70884255|NCT04206293|141253973|SUPERIORITY||LS Mean Difference|-0.034|STANDARD_ERROR_OF_MEAN|0.013||0.0194|TWO_SIDED|95.0|-0.062|-0.006|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Q2: Change from Baseline to Day 84||-0.006|-0.062|0.0194
70884256|NCT04206293|141253973|SUPERIORITY||LS Mean Difference|0.013|STANDARD_ERROR_OF_MEAN|0.007||0.0652|TWO_SIDED|95.0|-0.001|0.028|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Q3: Change from Baseline to Day 28||0.028|-0.001|0.0652
70884257|NCT04206293|141253973|SUPERIORITY||LS Mean Difference|0.012|STANDARD_ERROR_OF_MEAN|0.006||0.0756|TWO_SIDED|95.0|-0.001|0.024|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Q3: Change from Baseline to Day 84||0.024|-0.001|0.0756
70884258|NCT04206293|141253974|SUPERIORITY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|2.68||0.8409|TWO_SIDED|95.0|-6.19|5.1|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||5.10|-6.19|0.8409
70884259|NCT04206293|141253974|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|3.98||0.9183|TWO_SIDED|95.0|-9.18|8.35|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||8.35|-9.18|0.9183
70884260|NCT04206293|141253975|SUPERIORITY||LS Mean Difference|70.0|STANDARD_ERROR_OF_MEAN|77.0||0.4128|TWO_SIDED|95.0|-142.0|282.0|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||282|-142|0.4128
70884261|NCT04206293|141253975|SUPERIORITY||LS Mean Difference|-82.0|STANDARD_ERROR_OF_MEAN|79.0||0.3851|TWO_SIDED|95.0|-355.0|191.0|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||191|-355|0.3851
70884262|NCT04206293|141253976|SUPERIORITY||LS Mean Difference|6.52|STANDARD_ERROR_OF_MEAN|3.44||0.0798|TWO_SIDED|95.0|-0.89|13.93|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||13.93|-0.89|0.0798
70884263|NCT04206293|141253976|SUPERIORITY||LS Mean Difference|5.56|STANDARD_ERROR_OF_MEAN|3.27||0.1142|TWO_SIDED|95.0|-1.55|12.67|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||12.67|-1.55|0.1142
70963471|NCT02038920|141431733|SUPERIORITY||Odds Ratio (OR)|15.4||||0.0094|TWO_SIDED|95.0|1.473|160.972|||Pearson's Chi-square Test|||||160.972|1.473|0.0094
70884264|NCT04206293|141253977|SUPERIORITY||LS Mean Difference|0.96|STANDARD_ERROR_OF_MEAN|0.82||0.2592|TWO_SIDED|95.0|-0.78|2.71|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ra: Change from Baseline to Day 28||2.71|-0.78|0.2592
70884265|NCT04206293|141253977|SUPERIORITY||LS Mean Difference|1.09|STANDARD_ERROR_OF_MEAN|0.69||0.1341|TWO_SIDED|95.0|-0.38|2.57|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ra: Change from Baseline to Day 84||2.57|-0.38|0.1341
70884266|NCT04206293|141253977|SUPERIORITY||LS Mean Difference|5.91|STANDARD_ERROR_OF_MEAN|4.55||0.2138|TWO_SIDED|95.0|-3.79|15.61|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Rz: Change from Baseline to Day 28||15.61|-3.79|0.2138
70884267|NCT04206293|141253977|SUPERIORITY||LS Mean Difference|8.22|STANDARD_ERROR_OF_MEAN|4.2||0.07|TWO_SIDED|95.0|-0.77|17.2|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Rz: Change from Baseline to Day 84||17.20|-0.77|0.0700
70884268|NCT04206293|141253978|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|2.17||0.9608|TWO_SIDED|95.0|-4.7|4.91|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||4.91|-4.70|0.9608
70884269|NCT04206293|141253978|SUPERIORITY||LS Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|2.79||0.6192|TWO_SIDED|95.0|-7.48|4.64|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||4.64|-7.48|0.6192
70884270|NCT04206293|141253979|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.08||0.8322|TWO_SIDED|95.0|-0.2|0.16|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||0.16|-0.20|0.8322
70884271|NCT04206293|141253979|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.1334|TWO_SIDED|95.0|-0.25|0.04|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||0.04|-0.25|0.1334
70884272|NCT04206293|141253980|SUPERIORITY||LS Mean Difference|-5.09|STANDARD_ERROR_OF_MEAN|7.78||0.5221|TWO_SIDED|95.0|-21.56|11.38|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||11.38|-21.56|0.5221
70884273|NCT04206293|141253980|SUPERIORITY||LS Mean Difference|6.74|STANDARD_ERROR_OF_MEAN|8.07||0.4174|TWO_SIDED|95.0|-10.55|24.03|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||24.03|-10.55|0.4174
70884274|NCT04206293|141253981|SUPERIORITY||LS Mean Difference|2.77|STANDARD_ERROR_OF_MEAN|2.58||0.3052|TWO_SIDED|95.0|-2.9|8.44|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||8.44|-2.90|0.3052
70884275|NCT04206293|141253981|SUPERIORITY||LS Mean Difference|9.99|STANDARD_ERROR_OF_MEAN|2.57||0.0016|TWO_SIDED|95.0|4.48|15.5|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||15.50|4.48|0.0016
70884276|NCT04206293|141253982|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.48||0.1672|TWO_SIDED|95.0|-0.33|1.73|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||1.73|-0.33|0.1672
70884277|NCT04206293|141253982|SUPERIORITY||LS Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.29||0.0881|TWO_SIDED|95.0|-0.1|1.21|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||1.21|-0.10|0.0881
70884278|NCT04206293|141253983|SUPERIORITY||LS Mean Difference|0.57|STANDARD_ERROR_OF_MEAN|0.28||0.0577|TWO_SIDED|95.0|-0.02|1.17|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||1.17|-0.02|0.0577
70884279|NCT04206293|141253983|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.31||0.5224|TWO_SIDED|95.0|-0.85|0.45|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||0.45|-0.85|0.5224
70884280|NCT04206293|141253984|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.2666|TWO_SIDED|95.0|-0.6|0.2|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||0.2|-0.6|0.2666
70884281|NCT04206293|141253984|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4366|TWO_SIDED|95.0|-0.3|0.7|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||0.7|-0.3|0.4366
70884282|NCT04206293|141253985|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4197|TWO_SIDED|95.0|-0.6|0.3|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||a\*: Change from Baseline to Day 28||0.3|-0.6|0.4197
70884283|NCT04206293|141253985|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.914|TWO_SIDED|95.0|-0.6|0.5|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||a\*: Change from Baseline to Day 84||0.5|-0.6|0.9140
70884284|NCT04206293|141253985|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.7604|TWO_SIDED|95.0|-0.6|0.4|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||b\*: Change from Baseline to Day 28||0.4|-0.6|0.7604
70884285|NCT04206293|141253985|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.4||0.5936|TWO_SIDED|95.0|-1.0|0.6|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||b\*: Change from Baseline to Day 84||0.6|-1.0|0.5936
70884286|NCT04206293|141253985|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0808|TWO_SIDED|95.0|-0.9|0.1|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||L\*: Change from Baseline to Day 28||0.1|-0.9|0.0808
70884287|NCT04206293|141253985|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.1633|TWO_SIDED|95.0|-1.0|0.2|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||L\*: Change from Baseline to Day 84||0.2|-1.0|0.1633
70884288|NCT04206293|141253986|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.4||0.1977|TWO_SIDED|95.0|-1.6|0.4|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||0.4|-1.6|0.1977
70884289|NCT04206293|141253986|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.9||0.7535|TWO_SIDED|95.0|-2.2|1.7|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||1.7|-2.2|0.7535
70884290|NCT04206293|141253987|SUPERIORITY||LS Mean Difference|4.35|STANDARD_ERROR_OF_MEAN|3.95||0.2905|TWO_SIDED|95.0|-4.16|12.85|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||12.85|-4.16|0.2905
70884291|NCT04206293|141253987|SUPERIORITY||LS Mean Difference|17.27|STANDARD_ERROR_OF_MEAN|6.37||0.0241|TWO_SIDED|95.0|2.84|31.69|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||31.69|2.84|0.0241
70884292|NCT01454934|141253997|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.16||||0.1343|TWO_SIDED|95.0|0.95|1.41||P-value was calculated from a 2-sided long-rank test stratified by histology, TPC option, and geographic region.|Log Rank||Hazard Ratio was based on a Cox regression model including treatment as covariate, and histology, TPC option and geographic region as strata.|OS was compared between eribulin and TPC testing the following null hypothesis: H0: OS in Arm A (eribulin) is equal to OS in Arm B (TPC) against the alternative: H1: OS in Arm A (eribulin) is not equal to OS in Arm B (TPC).||1.41|0.95|0.1343
70884293|NCT01454934|141253998|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.09||||0.3946|TWO_SIDED|95.0|0.9|1.32||P-value was calculated from a 2-sided long-rank test stratified by histology, TPC option, and geographic region.|Log Rank||The hazard ratio was based on a Cox regression model including treatment as covariate, and histology, TPC option, and geographic region as strata.|OS was compared between eribulin and TPC testing the following null hypothesis: H0: OS in Arm A (eribulin) is equal to OS in Arm B (TPC) against the alternative: H1: OS in Arm A (eribulin) is not equal to OS in Arm B (TPC).||1.32|0.90|0.3946
70884294|NCT01454934|141253999|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3034||||||The P-value was stratified by histology, TPC option, and geographic region.|Cochran-Mantel-Haenszel|||OS was compared between eribulin and TPC testing the following null hypothesis: H0: OS in Arm A (eribulin) is equal to OS in Arm B (TPC) against the alternative: H1: OS in Arm A (eribulin) is not equal to OS in Arm B (TPC).||||0.3034
70884295|NCT01993108|141254036|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.02|TWO_SIDED||||||t-test, 2 sided|||||||.02
70884296|NCT01993108|141254036|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.118|TWO_SIDED||||||t-test, 2 sided|||||||.118
70884297|NCT01993108|141254036|SUPERIORITY||Median Difference (Final Values)|0.02||||0.349|TWO_SIDED||||||t-test, 2 sided|||||||.349
70884298|NCT01993108|141254036|SUPERIORITY||Median Difference (Final Values)|0.02||||0.348|TWO_SIDED||||||t-test, 2 sided|||||||.348
70884299|NCT01993108|141254037|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.019|TWO_SIDED||||||t-test, 2 sided|||||||.019
70884300|NCT01993108|141254037|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.24|TWO_SIDED||||||t-test, 2 sided|||||||.240
70884301|NCT01993108|141254037|SUPERIORITY||Median Difference (Final Values)|0.06||||0.081|TWO_SIDED||||||t-test, 2 sided|||||||.081
70884302|NCT01993108|141254037|SUPERIORITY||Median Difference (Final Values)|0.04||||0.247|TWO_SIDED||||||t-test, 2 sided|||||||.247
70884303|NCT01993108|141254038|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.049|TWO_SIDED||||||t-test, 2 sided|||||||.049
70884304|NCT01993108|141254038|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.497|TWO_SIDED||||||t-test, 2 sided|||||||.497
70884305|NCT01993108|141254038|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.814|TWO_SIDED||||||t-test, 2 sided|||||||.814
70884306|NCT01993108|141254038|SUPERIORITY||Mean Difference (Net)|0.01||||0.593|TWO_SIDED||||||t-test, 2 sided|||||||.593
70884307|NCT01993108|141254039|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.926|TWO_SIDED||||||t-test, 2 sided|||||||.926
70884308|NCT01993108|141254039|SUPERIORITY||Mean Difference (Final Values)|0.31||||0.126|TWO_SIDED||||||t-test, 2 sided|||||||.126
70884309|NCT01993108|141254039|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.852|TWO_SIDED||||||t-test, 2 sided|||||||.852
70884310|NCT01993108|141254039|SUPERIORITY||Median Difference (Final Values)|0.11||||0.552|TWO_SIDED||||||t-test, 2 sided|||||||.552
70884311|NCT01802775|141254041|OTHER||Treatment Difference|-3.9|||||TWO_SIDED|95.0|-17.3|9.5||||||Treatment difference was edoxaban - clopidogrel. For the treatment difference, 95% Confidence interval was calculated using a normal approximation to the binomial distribution.||9.5|-17.3|
70884312|NCT00386256|141254046|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Statistical analyses included descriptive statistics to assess demographic and medical characteristics, safety, text messaging or phone adherence, exercise adherence, and patient satisfaction. T-tests were used to determine significant differences between the HB text messaging and telephone groups (with inpatients and outpatients combined within each group). All analyses were conducted using SPSS version 14.0 for Windows.||||<.05
70963472|NCT02038920|141431734|SUPERIORITY||Odds Ratio (OR)|1.5||||0.6534|TWO_SIDED|95.0|0.254|8.844|||Pearson's Chi-square Test||MLN0002 group/placebo group.|||8.844|0.254|0.6534
70963473|NCT02038920|141431735|SUPERIORITY|||||||0.2059|||||||Pearson's Chi-square Test|||||||0.2059
70884313|NCT00386256|141254047|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Statistical analyses included descriptive statistics to assess demographic and medical characteristics, safety, text messaging or phone adherence, exercise adherence, and patient satisfaction. T-tests were used to determine significant differences between the HB text messaging and telephone groups (with inpatients and outpatients combined within each group). All analyses were conducted using SPSS version 14.0 for Windows.||||<.05
70884314|NCT00782210|141254052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.135|0.209|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.209|0.135|<0.0001
70884315|NCT00782210|141254052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.139|0.214|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.214|0.139|<0.0001
70884316|NCT00782210|141254053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.054|0.128|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.128|0.054|<0.0001
70884317|NCT00782210|141254053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.064|0.137|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.137|0.064|<0.0001
70884318|NCT00782210|141254054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.113|0.233|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 5 mcg qd minus Placebo|||0.233|0.113|<0.0001
70884319|NCT00782210|141254054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.108|0.229|||Mixed Models Analysis|Treatment, tiotropium stratum and baseline as fixed effects|Olo 10 mcg qd minus Placebo|||0.229|0.108|<0.0001
70884320|NCT00782210|141254055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.128|0.201|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.201|0.128|<0.0001
70884321|NCT00782210|141254055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.139|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.212|0.139|<0.0001
70963474|NCT02383589|141431745|SUPERIORITY||Difference in proportion|30.8|||<|0.0001|TWO_SIDED|95.0|14.7|45.15||The analysis was stratified by the stratification factors applied at randomization.|Cochran-Mantel-Haenszel|||||45.15|14.70|<0.0001
70884322|NCT00782210|141254056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.181|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.144|0.217|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.217|0.144|<0.0001
70884323|NCT00782210|141254056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.156|0.229|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.229|0.156|<0.0001
70884324|NCT00782210|141254057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.133|0.207|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.207|0.133|<0.0001
70884325|NCT00782210|141254057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.13|0.204|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.204|0.130|<0.0001
70884326|NCT00782210|141254058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.136|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.212|0.136|<0.0001
70884327|NCT00782210|141254058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.123|0.199|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.199|0.123|<0.0001
70884328|NCT00782210|141254059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.134|0.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.211|0.134|<0.0001
70884329|NCT00782210|141254059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.131|0.208|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.208|0.131|<0.0001
70884330|NCT00782210|141254060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.095|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.059|0.131|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.131|0.059|<0.0001
70963475|NCT02383589|141431746|SUPERIORITY|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||||||0.0005
70963476|NCT02383589|141431747|SUPERIORITY||Adjusted Rate Ratio|0.12|||<|0.0001|TWO_SIDED|95.0|0.05|0.29||The model was adjusted for the following covariates in addition to log (each participant's duration in study) as an offset: treatment, region, duration of illness, baseline PDAI activity score, and baseline prednisone dose.|Negative Binominal Regression|||||0.29|0.05|<0.0001
70884331|NCT00782210|141254060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.075|0.147|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.147|0.075|<0.0001
70884332|NCT00782210|141254061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.095|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.059|0.131|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.131|0.059|<0.0001
70884333|NCT00782210|141254061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.054|0.127|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.127|0.054|<0.0001
70884334|NCT00782210|141254062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.061|0.135|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.135|0.061|<0.0001
70884335|NCT00782210|141254062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.064|0.138|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.138|0.064|<0.0001
70884336|NCT00782210|141254063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.049|0.123|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.123|0.049|<0.0001
70884337|NCT00782210|141254063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.051|0.126|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.126|0.051|<0.0001
70884338|NCT00782210|141254064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.054|0.13|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.130|0.054|<0.0001
70884339|NCT00782210|141254064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.048|0.123|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.123|0.048|<0.0001
70884340|NCT00782210|141254065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.069|0.145|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.145|0.069|<0.0001
70884341|NCT00782210|141254065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.068|0.143|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.143|0.068|<0.0001
70884342|NCT00782210|141254066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.055|0.13|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.130|0.055|<0.0001
70884343|NCT00782210|141254066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.053|0.129|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.129|0.053|<0.0001
70884344|NCT00782210|141254067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.115|0.194|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.194|0.115|<0.0001
70884345|NCT00782210|141254067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.131|0.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.211|0.131|<0.0001
70884346|NCT00782210|141254068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.177|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.137|0.217|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.217|0.137|<0.0001
70884347|NCT00782210|141254068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.15|0.23|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.230|0.150|<0.0001
70884348|NCT00782210|141254069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.132|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.212|0.132|<0.0001
70884349|NCT00782210|141254069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.132|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.212|0.132|<0.0001
70884350|NCT00782210|141254070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.123|0.204|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.204|0.123|<0.0001
70884351|NCT00782210|141254070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.124|0.206|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.206|0.124|<0.0001
70884352|NCT00782210|141254071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.134|0.216|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.216|0.134|<0.0001
70884353|NCT00782210|141254071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.11|0.192|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.192|0.110|<0.0001
70884354|NCT00782210|141254072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.128|0.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.211|0.128|<0.0001
70884355|NCT00782210|141254072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.163|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.121|0.205|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.205|0.121|<0.0001
70884356|NCT00782210|141254073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.288|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.216|0.359|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.359|0.216|<0.0001
70884357|NCT00782210|141254073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.258|0.401|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.401|0.258|<0.0001
70884358|NCT00782210|141254074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.296|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.224|0.368|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.368|0.224|<0.0001
70884359|NCT00782210|141254074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.327|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.255|0.399|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.399|0.255|<0.0001
70884360|NCT00782210|141254075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.254|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.181|0.327|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.327|0.181|<0.0001
70884361|NCT00782210|141254075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.293|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.22|0.366|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.366|0.220|<0.0001
70884362|NCT00782210|141254076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.275|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.201|0.348|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.348|0.201|<0.0001
70884363|NCT00782210|141254076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.292|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.219|0.366|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.366|0.219|<0.0001
70884364|NCT00782210|141254077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.235|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.161|0.309|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.309|0.161|<0.0001
70963477|NCT02383589|141431748|SUPERIORITY||Hazard Ratio (HR)|4.83||||0.0003|TWO_SIDED|95.0|1.97|11.81||P-value is from a stratified log-rank test used to test the time to first disease flare between the RTX and MMF treatment arms over the 52-week treatment period, adjusting for the stratification factors applied at randomization|Log Rank|||||11.81|1.97|0.0003
70884365|NCT00782210|141254077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.254|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.18|0.329|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.329|0.180|<0.0001
70884366|NCT00782210|141254078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.244|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.169|0.319|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.319|0.169|<0.0001
70884367|NCT00782210|141254078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.271|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.196|0.346|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.346|0.196|<0.0001
70884368|NCT00782210|141254079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.076|0.218|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.218|0.076|<0.0001
70884369|NCT00782210|141254079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.113|0.255|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.255|0.113|<0.0001
70963478|NCT02383589|141431749|SUPERIORITY||Hazard Ratio (HR)|0.15|||<|0.0001|TWO_SIDED|95.0|0.06|0.39||P-value is from a stratified log-rank test used to test the time to first disease flare between the RTX and MMF treatment arms over the 52-week treatment period, adjusting for the stratification factors applied at randomization|Log Rank|||||0.39|0.06|<0.0001
70963479|NCT02383589|141431750|SUPERIORITY||Difference in Estimated Means|-2.872||||0.0012|TWO_SIDED|95.0|-4.577|-1.167||P-value is from Mixed Model Repeated Measures (MMRM) with unstructured covariance matrix, adjusting for treatment, region, duration of illness, baseline DLQI score, visit, and an interaction terms for visit × baseline DLQI score and visit × treatment|Mixed Model Repeated Measures|||||-1.167|-4.577|0.0012
70963480|NCT00866697|141431760|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.766||||0.0021|TWO_SIDED|95.0|0.643|0.911||The P-value from the stratified log-rank test was adjusted for the two stratification factors.|Log Rank||The Hazard Ratio was estimated using a Pike estimator.|||0.911|0.643|0.0021
70884370|NCT00782210|141254080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.037||0.0003||95.0|0.059|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.203|0.059|0.0003
70884371|NCT00782210|141254080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.036||0.0001||95.0|0.069|0.213|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.213|0.069|0.0001
70884372|NCT00782210|141254081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.037||0.0019||95.0|0.043|0.187|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.187|0.043|0.0019
70884373|NCT00782210|141254081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.088|0.233|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.233|0.088|<0.0001
70884374|NCT00782210|141254082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.037||0.0005||95.0|0.057|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.203|0.057|0.0005
70884375|NCT00782210|141254082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.089|0.235|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.235|0.089|<0.0001
70884376|NCT00782210|141254083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.083|STANDARD_ERROR_OF_MEAN|0.037||0.0261||95.0|0.01|0.156|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.156|0.010|0.0261
70884377|NCT00782210|141254083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.037||0.001||95.0|0.05|0.197|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.197|0.050|0.0010
70884378|NCT00782210|141254084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.038||0.0154||95.0|0.018|0.165|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.165|0.018|0.0154
70884379|NCT00782210|141254084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.038||0.0011||95.0|0.049|0.197|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.197|0.049|0.0011
70884380|NCT00782210|141254085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.038||0.0006||95.0|0.057|0.205|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.205|0.057|0.0006
70884381|NCT00782210|141254085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.08|0.229|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.229|0.080|<0.0001
70884382|NCT00782210|141254086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.038||0.0134||95.0|0.019|0.168|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.168|0.019|0.0134
70884383|NCT00782210|141254086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.038||0.0025||95.0|0.04|0.19|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.190|0.040|0.0025
70884384|NCT00782210|141254087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.263|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.187|0.339|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.339|0.187|<0.0001
70884385|NCT00782210|141254087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.225|0.376|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.376|0.225|<0.0001
70963481|NCT00866697|141431761|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.6431|TWO_SIDED|95.0|0.805|1.145|||Log Rank|Stratified Log-Rank P-Value.|"The HR was estimated using a Pike estimator.~CIs were estimated using the Brookmeyer-Crowley method."|||1.145|0.805|0.6431
70884386|NCT00782210|141254088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.264|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.188|0.341|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.341|0.188|<0.0001
70884387|NCT00782210|141254088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.292|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.216|0.368|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.368|0.216|<0.0001
70884388|NCT00782210|141254089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.174|0.328|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.328|0.174|<0.0001
70884389|NCT00782210|141254089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.203|0.358|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.358|0.203|<0.0001
70884390|NCT00782210|141254090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.174|0.329|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.329|0.174|<0.0001
70884391|NCT00782210|141254090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.183|0.338|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.338|0.183|<0.0001
70884392|NCT00782210|141254091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.153|0.31|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.310|0.153|<0.0001
70884393|NCT00782210|141254091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.154|0.311|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.311|0.154|<0.0001
70884394|NCT00782210|141254092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.247|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.168|0.327|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.327|0.168|<0.0001
70884395|NCT00782210|141254092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.181|0.34|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.340|0.181|<0.0001
70884396|NCT00782210|141254093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.302|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.181|0.422|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 5 mcg qd minus Placebo|||0.422|0.181|<0.0001
70884397|NCT00782210|141254093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.249|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.128|0.37|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 10 mcg qd minus Placebo|||0.370|0.128|<0.0001
70884398|NCT00782210|141254094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.357|STANDARD_ERROR_OF_MEAN|4.253||0.0018|TWO_SIDED|95.0|5.005|21.709|||ANCOVA|non-MMRM ANCOVA models by week, with treatment, tiotropium strata and baseline as fixed effects.||||21.709|5.005|0.0018
70884399|NCT00782210|141254094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.457|STANDARD_ERROR_OF_MEAN|4.248||0.0003|TWO_SIDED|95.0|7.114|23.8|||ANCOVA|non-MMRM ANCOVA models by week, with treatment, tiotropium strata and baseline as fixed effects.||||23.800|7.114|0.0003
70884400|NCT00782210|141254095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.186|STANDARD_ERROR_OF_MEAN|4.245|<|0.0001|TWO_SIDED|95.0|8.849|25.523|||ANCOVA|non-MMRM ANCOVA models by week, with treatment, tiotropium strata and baseline as fixed effects.||||25.523|8.849|<0.0001
70884401|NCT00782210|141254095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.56|STANDARD_ERROR_OF_MEAN|4.226||0.0006|TWO_SIDED|95.0|6.259|22.86|||ANCOVA|non-MMRM ANCOVA models by week, with treatment, tiotropium strata and baseline as fixed effects.||||22.860|6.259|0.0006
70884402|NCT00782210|141254096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.182||0.0045|TWO_SIDED|95.0|-0.878|-0.162|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.162|-0.878|0.0045
70884403|NCT00782210|141254096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.648|STANDARD_ERROR_OF_MEAN|0.182||0.0004|TWO_SIDED|95.0|-1.005|-0.291|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.291|-1.005|0.0004
70884404|NCT00782210|141254097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.582|STANDARD_ERROR_OF_MEAN|0.202||0.0041|TWO_SIDED|95.0|-0.979|-0.185|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.185|-0.979|0.0041
70884405|NCT00782210|141254097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.792|STANDARD_ERROR_OF_MEAN|0.202||0.0001|TWO_SIDED|95.0|-1.189|-0.394|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.394|-1.189|0.0001
70884406|NCT00782210|141254098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.104|STANDARD_ERROR_OF_MEAN|0.354||0.0019|TWO_SIDED|95.0|-1.799|-0.409|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.409|-1.799|0.0019
70884407|NCT00782210|141254098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.435|STANDARD_ERROR_OF_MEAN|0.354|<|0.0001|TWO_SIDED|95.0|-2.13|-0.74|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.740|-2.130|<0.0001
70884408|NCT00782210|141254099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.7|-0.3|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.3|-0.7|<0.0001
70884409|NCT00782210|141254099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.7|-0.3|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.3|-0.7|<0.0001
70884410|NCT00782210|141254100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.7|-0.2|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.2|-0.7|<0.0001
70884411|NCT00782210|141254100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.6|-0.2|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.2|-0.6|<0.0001
70884412|NCT00782210|141254101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.7|-0.2|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.2|-0.7|<0.0001
70884413|NCT00782210|141254101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.7|-0.2|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.2|-0.7|<0.0001
70884414|NCT00782210|141254102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0109||95.0|-0.5|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum,visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.1|-0.5|0.0109
70884415|NCT00782210|141254102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0031||95.0|-0.6|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.1|-0.6|0.0031
70884416|NCT00782210|141254103|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.728|STANDARD_ERROR_OF_MEAN|0.124||0.0658|TWO_SIDED|95.0|0.522|1.016|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.016|0.522|0.0658
70884417|NCT00782210|141254103|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.799|STANDARD_ERROR_OF_MEAN|0.133||0.1701|TWO_SIDED|95.0|0.576|1.107|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.107|0.576|0.1701
70884418|NCT00782210|141254104|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.656|STANDARD_ERROR_OF_MEAN|0.247||0.2754|TWO_SIDED|95.0|0.313|1.374|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.374|0.313|0.2754
70884419|NCT00782210|141254104|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01|STANDARD_ERROR_OF_MEAN|0.342||0.9792|TWO_SIDED|95.0|0.521|1.961|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.961|0.521|0.9792
70963482|NCT03872453|141431854|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|4.2||||0.1214|TWO_SIDED|98.3|-2.3|10.7||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||||10.7|-2.3|0.1214
70884420|NCT00782210|141254105|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.739|STANDARD_ERROR_OF_MEAN|0.142||0.1194|TWO_SIDED|95.0|0.506|1.078|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.078|0.506|0.1194
70884421|NCT00782210|141254105|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.811|STANDARD_ERROR_OF_MEAN|0.153||0.257|TWO_SIDED|95.0|0.561|1.174|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.174|0.561|0.2570
70884422|NCT00782210|141254106|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.7815|STANDARD_ERROR_OF_MEAN|0.138||0.1631|TWO_SIDED|95.0|0.5524|1.1054|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.1054|0.5524|0.1631
70884423|NCT00782210|141254106|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.8456|STANDARD_ERROR_OF_MEAN|0.1467||0.3342|TWO_SIDED|95.0|0.6015|1.1889|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.1889|0.6015|0.3342
70884424|NCT00782210|141254107|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.655|STANDARD_ERROR_OF_MEAN|0.2664||0.2985|TWO_SIDED|95.0|0.2947|1.4556|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.4556|0.2947|0.2985
70884425|NCT00782210|141254107|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.1211|STANDARD_ERROR_OF_MEAN|0.4103||0.755|TWO_SIDED|95.0|0.5464|2.3003|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||2.3003|0.5464|0.7550
70884426|NCT00782210|141254108|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.8081|STANDARD_ERROR_OF_MEAN|0.163||0.2911|TWO_SIDED|95.0|0.5438|1.2008|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.2008|0.5438|0.2911
70884427|NCT00782210|141254108|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.8485|STANDARD_ERROR_OF_MEAN|0.1686||0.4086|TWO_SIDED|95.0|0.5743|1.2535|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.2535|0.5743|0.4086
70884428|NCT00048542|141254145|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Chi-square test|||The study was sized to detect a difference in the proportion of subjects (40%) between placebo and the active adalimumab dose group who would experience disease flare assuming a placebo rate of 70% vs. a rate of 30% in the active group. Assuming a binomial distribution, an alpha of 0.05, 80% power, two-sided test, and an initial monotherapy responder rate of 70%, a minimum of 29 subjects were needed per treatment group within the appropriate strata.||||0.031
70884429|NCT00048542|141254147|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||Chi-square test|||||||0.015
70884430|NCT00048542|141254148|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Log Rank|||||||0.029
70884431|NCT00048542|141254149|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Log Rank|||||||0.031
70884432|NCT00048542|141254150|SUPERIORITY_OR_OTHER|||||||0.061||95.0|||||Pearson's Chi-square test|||||||0.061
70884433|NCT00048542|141254150|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Pearson's Chi-square test|||||||0.028
70884434|NCT00048542|141254151|SUPERIORITY_OR_OTHER|||||||0.103||95.0|||||Pearson's Chi-square test|||||||0.103
70884435|NCT00048542|141254151|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Pearson's Chi-square test|||||||0.028
70884436|NCT00048542|141254152|SUPERIORITY_OR_OTHER|||||||0.156||95.0|||||Pearson's Chi-square test|||||||0.156
70884437|NCT00048542|141254152|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Pearson's Chi-square test|||||||0.002
70884438|NCT02272413|141254192|EQUIVALENCE|The null hypothesis was to be rejected in favor of equivalence if the 2-sided 90% confidence interval (CI) for the ratio in best ORR between the treatments was entirely contained within the equivalence margins of 0.736 to 1.359.|Ratio of best ORR|0.855|||||TWO_SIDED|90.0|0.7697|0.9506|||Log-binomial regression|||Analysis was based on a log-binomial regression model with subsequent transformation of the estimated parameter (ratio of best ORR) respective CIs to the ratio scale. The model included the following explanatory variables: treatment, sex (male versus female), smoking status (never smoked versus current/ex-smoker), NSCLC stage (recurrent versus Stage IV) and ethnicity (East Asian origin versus Non-East Asian).||0.9506|0.7697|
70884439|NCT02272413|141254192|EQUIVALENCE|Additional analysis of the primary endpoint was performed for Japan according to a local protocol amendment Japan. For the submission in Japan, to conclude on equivalence, the 2-sided 95% CI for the ratio of best ORR between the treatments had to be entirely contained within the equivalence margins of 0.736 to 1.359.|Ratio of best ORR|0.855|||||TWO_SIDED|95.0|0.7543|0.97|||Log-binomial regression|||Analysis was based on a log-binomial regression model with subsequent transformation of the estimated parameter (ratio of best ORR) respective CIs to the ratio scale. The model included the following explanatory variables: treatment, sex (male versus female), smoking status (never smoked versus current/ex-smoker), NSCLC stage (recurrent versus Stage IV) and ethnicity (East Asian origin versus Non-East Asian).||0.9700|0.7543|
70884440|NCT02272413|141254193|OTHER||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.99|1.37|||Score exact method|||At least 1 AE selected for comparability assessment, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||1.37|0.99|
70884441|NCT02272413|141254193|OTHER||Risk Ratio (RR)|1.28|||||TWO_SIDED|95.0|0.88|1.88|||Score exact method|||Infusion reactions, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||1.88|0.88|
70884442|NCT02272413|141254193|OTHER||Risk Ratio|1.2|||||TWO_SIDED|95.0|0.64|2.32|||Score exact method|||Thromboembolic events, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||2.32|0.64|
70884443|NCT02272413|141254193|OTHER||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.51|2.76|||Score exact method|||Febrile neutropenia, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||2.76|0.51|
70884444|NCT02272413|141254193|OTHER||Risk Ratio (RR)|3.43|||||TWO_SIDED|95.0|0.79|32.82|||Score exact method|||Gastrointestinal perforations, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||32.82|0.79|
70884445|NCT02272413|141254193|OTHER||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.66|1.39|||Score exact method|||Hypertension, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||1.39|0.66|
70884446|NCT02272413|141254193|OTHER||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.74|1.57|||Score exact method|||Proteinuria, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||1.57|0.74|
70884447|NCT02272413|141254193|OTHER||Risk Ratio (RR)|1.31|||||TWO_SIDED|95.0|0.28|10.79|||Score exact method|||Pulmonary haemorrhage, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||10.79|0.28|
70884448|NCT02272413|141254193|OTHER||Risk Ratio (RR)|1.24|||||TWO_SIDED|95.0|0.88|1.74|||Score exact method|||Other hemorrhages, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||1.74|0.88|
70884449|NCT02272413|141254193|OTHER||Risk Ratio (RR)|1.26|||||TWO_SIDED|95.0|0.47|3.57|||Score excat method|||Wound healing complications/ abscesses/ fistulas, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||3.57|0.47|
70963483|NCT03872453|141431854|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|7.0||||0.0113|TWO_SIDED|98.3|0.4|13.7||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||||13.7|0.4|0.0113
70963484|NCT03872453|141431854|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|7.7||||0.0055|TWO_SIDED|98.3|1.1|14.3||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||||14.3|1.1|0.0055
70963485|NCT03872453|141431855|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|5.4||||0.1162|TWO_SIDED|98.3|-2.8|13.6||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||||13.6|-2.8|0.1162
70963486|NCT03872453|141431855|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|8.3||||0.0155|TWO_SIDED|98.3|0.1|16.5||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||||16.5|0.1|0.0155
70963487|NCT03872453|141431855|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|8.9||||0.0094|TWO_SIDED|98.3|0.7|17.0||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||||17.0|0.7|0.0094
70963488|NCT03872453|141431856|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|7.1||||0.0439|TWO_SIDED|98.3|-1.3|15.4||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||If the coprimary endpoint tests were both significant for a zavegepant dose group versus placebo, the secondary endpoints were tested for that zavegepant dose group versus placebo using a hierarchical gate-keeping procedure in the order the endpoints are reported, with each test in the hierarchy conducted at alpha = 0.0167. If a test in the hierarchy was not significant, any further tests on endpoints in the sequence were not considered significant for any zavegepant dose group versus placebo.||15.4|-1.3|0.0439
70963489|NCT03872453|141431856|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|7.5||||0.0302|TWO_SIDED|98.3|-0.8|15.9||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||If the coprimary endpoint tests were both significant for a zavegepant dose group versus placebo, the secondary endpoints were tested for that zavegepant dose group versus placebo using a hierarchical gate-keeping procedure in the order the endpoints are reported, with each test in the hierarchy conducted at alpha = 0.0167. If a test in the hierarchy was not significant, any further tests on endpoints in the sequence were not considered significant for any zavegepant dose group versus placebo.||15.9|-0.8|0.0302
70963490|NCT00863109|141431887|SUPERIORITY_OR_OTHER|||||||0.027|||||||Student´s t-test for paired samples|||Within-group comparison of Worry domain between BL Visit and WK72 Visit||||0.027
70963491|NCT00863109|141431888|SUPERIORITY_OR_OTHER|||||||0.038|||||||Student´s t-test for paired samples|||Between-group comparison of change from baseline in MCS||||0.038
70963492|NCT00863109|141431889|SUPERIORITY_OR_OTHER|||||||0.014|||||||Student´s t-test for paired samples|||Between-group comparison of change from baseline in Emotional Function domain||||0.014
70963493|NCT00863109|141431889|SUPERIORITY_OR_OTHER|||||||0.009|||||||Student´s t-test for paired samples|||Between-group comparison of change from baseline in Worry domain||||0.009
70963494|NCT00863109|141431889|SUPERIORITY_OR_OTHER|||||||0.022|||||||Student´s t-test for paired samples|||Between-group comparison of change from baseline in CLDQ-HCV Global domain||||0.022
70963495|NCT00440700|141431910|SUPERIORITY_OR_OTHER||Slope|15.5|||<|0.05||95.0|||||Mixed Models Analysis|||Mixed models analysis was used to determine if there were any differences in anxiety levels in patients who listen to music as compared to headphones only or usual ICU care.||||<0.05
70963496|NCT00440700|141431912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|0.61|<|0.05|ONE_SIDED|95.0|||||Kruskal-Wallis||Usual care was the reference comparison group.|Length of mechanical ventilatory support was assessed among all 3 groups. Usual usual care was the reference group as compared to the experimental patient-directed music group.||||<0.05
70963497|NCT00440700|141431913|SUPERIORITY_OR_OTHER||Slope|5.0|||<|0.05||95.0|||||Mixed Models Analysis|||Cortisol levels were compared among all 3 groups.||||<0.05
70963498|NCT01423812|141431916|OTHER||||||<|0.05|||||||t-test, 2 sided|||p value||||<0.05
70884450|NCT02272413|141254194|OTHER||Hazard Ratio (HR)|1.22|||||TWO_SIDED|95.0|1.02|1.45|||Cox-proportional hazards regression|||Analysis based on a Cox-proportional hazards regression model. The model included the following explanatory variables: treatment, sex (male versus female), smoking status (never smoked versus current/ex-smoker), NSCLC stage (recurrent versus Stage IV) and ethnicity (East Asian origin versus non East Asian).||1.45|1.02|
70963499|NCT01423812|141431917|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70963500|NCT01179672|141431921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.03|TWO_SIDED|95.0|-0.82|-0.04|||Mixed Models Analysis|||||-0.04|-0.82|0.030
70963501|NCT01179672|141431922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.008|TWO_SIDED|95.0|-0.95|-0.14||P-value is for mean change from baseline to 12-week endpoint in night pain.|Mixed Models Analysis|||||-0.14|-0.95|0.008
70963502|NCT01179672|141431922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.017|TWO_SIDED|95.0|-1.0|-0.1||P-value is for mean change from baseline to 12 week endpoint in worst pain.|Mixed Models Analysis|||||-0.10|-1.00|0.017
70963503|NCT01179672|141431923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.016|TWO_SIDED|95.0|-0.9|-0.09|||Mixed Models Analysis|||||-0.09|-0.90|0.016
70963504|NCT01179672|141431924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.081|TWO_SIDED|95.0|-0.48|0.03|||Mixed Models Analysis|||||0.03|-0.48|0.081
70884451|NCT02272413|141254195|OTHER||Hazard Ratio (HR)|1.23|||||TWO_SIDED|95.0|1.0|1.51|||Cox-proportional hazards regression|||Analysis based on a Cox-proportional hazards regression model. The model included the following explanatory variables: treatment, sex (male versus female), smoking status (never smoked versus current/ex-smoker), NSCLC stage (recurrent versus Stage IV) and ethnicity (East Asian origin versus non East Asian).||1.51|1.00|
70884452|NCT02272413|141254196|OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.88|1.48|||Cox-proportional hazards regression|||Analysis based on a Cox-proportional hazards regression model. The model included the following explanatory variables: treatment, sex (male versus female), smoking status (never smoked versus current/ex-smoker), NSCLC stage (recurrent versus Stage IV) and ethnicity (East Asian origin versus non East Asian).||1.48|0.88|
70884453|NCT01461096|141254214|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78||||0.35|TWO_SIDED|95.1|0.47|1.31||P-value was unadjusted for multiple comparisons and a P-value less than 5% was the threshold for statistical significance.|generalized log-rank test (Sun 1996)|The generalized log-rank test (Sun 1996) was performed to evaluate whether participants in the two arms had the same survival rate.|qHPV group represented the numerator for the hazard ratio and Placebo group represented the denominator.|||1.31|0.47|0.350
70884454|NCT01417481|141254248|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 1 sided|Due to the cross-over, a paired analysis was done. The hypothesis was that glycine will improve variables, and thus significance was set at one-tail.||||||>0.05
70884455|NCT01417481|141254249|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 1 sided|The hypothesis was that glycine will improve inflammatory biomarkers, and thus statistical significance was set at one-tail.||||||>0.05
70884456|NCT01417481|141254250|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 1 sided|The hypothesis was that glycine will improve inflammatory biomarkers, and thus statistical significance was set at one-tail.||||||>0.05
70884457|NCT01417481|141254251|SUPERIORITY_OR_OTHER||||||=|0.061|TWO_SIDED||||||t-test, 1 sided|The hypothesis was that glycine will improve inflammatory biomarkers, and thus statistical significance was set at one-tail.||||||=0.061
70884458|NCT01417481|141254252|SUPERIORITY_OR_OTHER||||||=|0.068|TWO_SIDED||||||t-test, 1 sided|The hypothesis was that glycine will improve inflammatory biomarkers, and thus statistical significance was set at one-tail.||||||=0.068
70884459|NCT01417481|141254253|SUPERIORITY_OR_OTHER||||||=|0.04|TWO_SIDED||||||t-test, 1 sided|The hypothesis was that glycine will improve inflammatory biomarkers, and thus statistical significance was set at one-tail.||||||=0.040
70884460|NCT01417481|141254254|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|Due to the cross-over, a paired analysis was done. The hypothesis was that glycine will improve variables, and thus significance was set at one-tail.||||||<0.05
70884461|NCT01417481|141254255|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|Due to the cross-over, paired analysis was done. The hypothesis was that glycine will improve variables, thus significance was set at one-tail.||||||<0.05
70884462|NCT01417481|141254256|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 1 sided|Due to the cross-over, a paired analysis was done. The hypothesis was that glycine will improve variables, and thus significance was set at one-tail.||||||<0.01
70884463|NCT01417481|141254257|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 1 sided|Due to the cross-over, a paired analysis was done. The hypothesis was that glycine will improve variables, and thus significance was set at one-tail.||||||>0.05
70884464|NCT04630093|141254265|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Baseline vs. 6 months after receiving panel-based pharmacogenetic testing||||0.001
70884465|NCT04296396|141254270|NON_INFERIORITY|A non-inferiority design assumed a noninferiority margin of 5%. For 90% power and 0.025 significance level 1-sided, a total sample size of 4,300 participants was required to state that the IOPP is not inferior to the fixed amount of 20 tablets. Given the short window to assess pain at 1-week post-discharge, a 20% missing rate was incorporated which gives a final sample size of 5,500 (2,750 per group).|Risk Difference (RD)|0.67|||||TWO_SIDED|95.0|-2.03|3.37|||||The risk difference is the rate in the fixed group minus the rate in the IOPP group. IOPP was to be determined as non-inferior if the lower 95% confidence limit for the risk difference is -5 percentage points or greater (i.e., closer to zero).|||3.37|-2.03|
70884466|NCT04296396|141254271|SUPERIORITY||Risk Ratio (RR)|1.22||||0.046|TWO_SIDED|96.25|0.99|1.51|||Chi-squared||Confidence interval is 96.25% due to false discovery rate adjustment|||1.51|0.99|0.046
70884467|NCT04296396|141254272|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
70884468|NCT04296396|141254273|SUPERIORITY||Median Difference (Net)|-5.0|||<|0.001|TWO_SIDED|97.5|-6.6|-3.5|||quantile regression||Confidence interval is 97.5% due to false discovery rate adjustment|||-3.5|-6.6|<0.001
70884469|NCT04296396|141254274|SUPERIORITY||Median Difference (Net)|-15.0|||<|0.001|TWO_SIDED|98.75|-19.2|-10.8|||quartile regression||Confidence interval is 98.75% due to false discovery rate adjustment|||-10.8|-19.2|<0.001
70884470|NCT04296396|141254275|SUPERIORITY||Median Difference (Net)|0.0||||1|TWO_SIDED|95.0|0.0|0.0|||quantile regression|||||0|0|1.0
70884471|NCT04296396|141254276|SUPERIORITY||Risk Ratio (RR)|0.96||||0.52|TWO_SIDED|95.0|0.85|1.09|||Chi-squared|||||1.09|0.85|0.52
70884472|NCT04296396|141254277|SUPERIORITY||Risk Ratio (RR)|0.99||||0.15|TWO_SIDED|95.0|0.98|1.0|||Regression, Linear|||||1.00|0.98|0.15
70884473|NCT01077960|141254280|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
70884474|NCT01077960|141254281|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
70884475|NCT01077960|141254282|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
70884476|NCT01077960|141254283|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
70884477|NCT01077960|141254284|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|||||||0.007
70884478|NCT01077960|141254285|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||t-test, 2 sided|||||||0.015
70884479|NCT00847288|141254294|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.5||||0.0043|TWO_SIDED|95.0|1.1|2.0||Cox proportional hazard model was fitted with the group effect and other key baseline variables. The p-value for the main group effect is 0.0043, with an estimated hazard ratio of 1.5, monthly vs quarterly.|Regression, Cox|||"Let TM and TQ denote the median survival time to initiation of clinical action in monthly and quarterly review groups respectively. Null Hypothesis (HO): The time to initiation of clinical action is not affected by review frequency (monthly versus quarterly): TM=TQ Alternative Hypothesis (HA): The time to initiation of clinical action is affected by review frequency (monthly versus quarterly): TM≠TQ~Cox proportional hazard model will be fitted to estimate the hazard ratio."||2.0|1.1|0.0043
70884480|NCT00847288|141254296|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.0001|TWO_SIDED|95.0|1.2|1.74|||logistic GEE for repeated observations|||The probability of action taken in three months interval is evaluated using the generalized estimating equations (GEE) method under a logistic regression model. Univariate analysis is performed first for potential predictors and only those with a p-value less than 0.10 through univariate analysis are included in the multivariate model. Here we report the odds ratio of monthly arm against quarterly arm, adjusting for OptiVol crossing, new or chronic device, and AF or no AF.||1.74|1.20|0.0001
70884481|NCT04448210|141254298|SUPERIORITY||||||<|0.25|||||||ANOVA|||||||<.25
70884482|NCT04448210|141254299|SUPERIORITY|||||||0.72|||||||ANOVA|||||||.72
70884483|NCT04448210|141254300|SUPERIORITY|||||||0.16|||||||ANOVA|||||||.16
70884484|NCT04448210|141254301|SUPERIORITY|||||||0.43|||||||ANOVA|||||||.43
70884485|NCT04448210|141254302|SUPERIORITY|||||||0.69|||||||ANOVA|||||||.69
70884486|NCT04448210|141254303|SUPERIORITY|||||||0.38|||||||ANOVA|||||||.38
70884487|NCT04448210|141254304|SUPERIORITY|||||||0.94|||||||ANOVA|||||||.94
70884488|NCT04448210|141254305|SUPERIORITY|||||||0.94|||||||ANOVA|||||||.94
70884489|NCT04448210|141254306|SUPERIORITY|||||||0.3|||||||ANOVA|||||||.30
70884490|NCT00717769|141254473|SUPERIORITY|||||||0.519|||||||ANCOVA|||Change from Baseline to Day 8||||0.519
70884491|NCT00717769|141254473|SUPERIORITY|||||||0.032|||||||ANCOVA|||Change from Baseline to Day 15||||0.032
70884492|NCT00717769|141254473|SUPERIORITY|||||||0.008|||||||ANCOVA|||Change from Baseline to Day 22||||0.008
70884493|NCT00717769|141254473|SUPERIORITY|||||||0.006|||||||ANCOVA|||Change from Baseline to Day 29||||0.006
70884494|NCT00717769|141254475|SUPERIORITY|||||||0.533|||||||ANCOVA|||Change from Baseline to Day 8||||0.533
70884495|NCT00717769|141254475|SUPERIORITY|||||||0.009|||||||ANCOVA|||Change from Baseline to Day 15||||0.009
70884496|NCT00717769|141254475|SUPERIORITY|||||||0.002|||||||ANCOVA|||Change from Baseline to Day 22||||0.002
70884497|NCT00717769|141254475|SUPERIORITY|||||||0.003|||||||ANCOVA|||Change from Baseline to Day 29||||0.003
70884498|NCT01153581|141254493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
70884499|NCT01399593|141254494|SUPERIORITY||Proportion difference|-3.9||||0.76|TWO_SIDED|95.0|-23.9|16.3|||Fisher Exact|||||16.3|-23.9|0.76
70884500|NCT00244712|141254498|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the ABC/3TC to the TDF/FTC would be declared if the lower limit of the 2-sided 95% confidence interval on the difference in the percentage of participants with HIV-1 RNA \<50 copies/mL at Week 48 \[ABC/3TC minus TDF/FTC\] was -12% or greater.|difference in response percentage|0.39||||0.913||95.0|-6.63|7.4|||Cochran-Mantel-Haenszel||Difference in response percentage = percentage in Arm 1 minus percentage in Arm 2|||7.40|-6.63|0.913
70884501|NCT01336738|141254522|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.164||0.6803|TWO_SIDED|80.0|-0.13|0.29||One-sided p-value was calculated.|Mixed Models Analysis|||Treatment difference and 80% confidence interval (CI) were based on LS mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.29|-0.13|0.6803
70884502|NCT01336738|141254522|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.166||0.0017|TWO_SIDED|80.0|-0.71|-0.28||One-sided p-value was calculated.|Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.28|-0.71|0.0017
70884503|NCT01336738|141254522|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.168||0.0003|TWO_SIDED|80.0|-0.8|-0.36||One-sided p-value was calculated.|Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.36|-0.80|0.0003
70884504|NCT01336738|141254522|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.162|<|0.0001|TWO_SIDED|80.0|-0.91|-0.5||One-sided p-value was calculated.|Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.50|-0.91|<0.0001
70884505|NCT01336738|141254523|SUPERIORITY_OR_OTHER||LS Mean Difference|3.78|STANDARD_ERROR_OF_MEAN|5.292||0.4757|TWO_SIDED|95.0|-6.64|14.2||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||14.20|-6.64|0.4757
70884506|NCT01336738|141254523|SUPERIORITY_OR_OTHER||LS Mean Difference|1.32|STANDARD_ERROR_OF_MEAN|5.296||0.8031|TWO_SIDED|95.0|-9.11|11.75||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||11.75|-9.11|0.8031
70884507|NCT01336738|141254523|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.22|STANDARD_ERROR_OF_MEAN|5.364||0.549|TWO_SIDED|95.0|-13.78|7.34||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||7.34|-13.78|0.5490
70884508|NCT01336738|141254523|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.07|STANDARD_ERROR_OF_MEAN|5.34||0.0051|TWO_SIDED|95.0|-25.58|-4.55||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-4.55|-25.58|0.0051
70884509|NCT01336738|141254523|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.43|STANDARD_ERROR_OF_MEAN|5.02||0.6291|TWO_SIDED|95.0|-12.31|7.46||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||7.46|-12.31|0.6291
70884510|NCT01336738|141254523|SUPERIORITY_OR_OTHER||LS Mean Difference|3.87|STANDARD_ERROR_OF_MEAN|5.001||0.4396|TWO_SIDED|95.0|-5.98|13.72||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||13.72|-5.98|0.4396
70884511|NCT01336738|141254523|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.56|STANDARD_ERROR_OF_MEAN|5.03||0.1934|TWO_SIDED|95.0|-16.46|3.34||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||3.34|-16.46|0.1934
70884512|NCT01336738|141254523|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.32|STANDARD_ERROR_OF_MEAN|5.039||0.0007|TWO_SIDED|95.0|-27.24|-7.4||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-7.40|-27.24|0.0007
70884513|NCT01336738|141254523|SUPERIORITY_OR_OTHER||LS Mean Difference|3.13|STANDARD_ERROR_OF_MEAN|5.201||0.5479|TWO_SIDED|95.0|-7.11|13.37||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||13.37|-7.11|0.5479
70884514|NCT01336738|141254523|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.14|STANDARD_ERROR_OF_MEAN|5.209||0.4276|TWO_SIDED|95.0|-14.39|6.12||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||6.12|-14.39|0.4276
70884515|NCT01336738|141254523|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.38|STANDARD_ERROR_OF_MEAN|5.235||0.1596|TWO_SIDED|95.0|-17.69|2.92||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.92|-17.69|0.1596
70884516|NCT01336738|141254523|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.83|STANDARD_ERROR_OF_MEAN|5.198|<|0.0001|TWO_SIDED|95.0|-33.06|-12.6||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-12.60|-33.06|<0.0001
70884517|NCT01336738|141254523|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|5.855||0.8509|TWO_SIDED|95.0|-12.63|10.43||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||10.43|-12.63|0.8509
70884518|NCT01336738|141254523|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.53|STANDARD_ERROR_OF_MEAN|5.913||0.1505|TWO_SIDED|95.0|-20.17|3.12||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||3.12|-20.17|0.1505
70884519|NCT01336738|141254523|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.62|STANDARD_ERROR_OF_MEAN|5.94||0.2662|TWO_SIDED|95.0|-18.31|5.08||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||5.08|-18.31|0.2662
70884520|NCT01336738|141254523|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.52|STANDARD_ERROR_OF_MEAN|5.818||0.0003|TWO_SIDED|95.0|-32.97|-10.07||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-10.07|-32.97|0.0003
70884521|NCT01336738|141254523|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.01|STANDARD_ERROR_OF_MEAN|6.94||0.7724|TWO_SIDED|95.0|-15.68|11.66||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||11.66|-15.68|0.7724
70884522|NCT01336738|141254523|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|6.986||0.9202|TWO_SIDED|95.0|-14.47|13.07||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||13.07|-14.47|0.9202
70884523|NCT01336738|141254523|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.61|STANDARD_ERROR_OF_MEAN|6.998||0.8183|TWO_SIDED|95.0|-15.4|12.18||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||12.18|-15.40|0.8183
70884524|NCT01336738|141254523|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.96|STANDARD_ERROR_OF_MEAN|6.821||0.0003|TWO_SIDED|95.0|-38.4|-11.53||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-11.53|-38.40|0.0003
70884525|NCT01336738|141254524|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.048||0.2327|TWO_SIDED|80.0|-0.1|0.03||One-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.03|-0.10|0.2327
70963505|NCT01179672|141431925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.034|TWO_SIDED|95.0|-0.4|-0.02|||Mixed Models Analysis|||||-0.02|-0.40|0.034
70884526|NCT01336738|141254524|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.048||0.358|TWO_SIDED|80.0|-0.08|0.04||One-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.04|-0.08|0.3580
70884527|NCT01336738|141254524|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.049||0.0036|TWO_SIDED|80.0|-0.2|-0.07||One-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.07|-0.20|0.0036
70884528|NCT01336738|141254524|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.049||0.1251|TWO_SIDED|80.0|-0.12|0.01||One-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.01|-0.12|0.1251
70884529|NCT01336738|141254524|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.066||0.3466|TWO_SIDED|80.0|-0.11|0.06||One-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.06|-0.11|0.3466
70884530|NCT01336738|141254524|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.066||0.0439|TWO_SIDED|80.0|-0.2|-0.03||One-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.03|-0.20|0.0439
70884531|NCT01336738|141254524|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.067||0.004|TWO_SIDED|80.0|-0.27|-0.09||One-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.09|-0.27|0.0040
70884532|NCT01336738|141254524|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.065||0.0009|TWO_SIDED|80.0|-0.29|-0.12||One-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.12|-0.29|0.0009
70884533|NCT01336738|141254524|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.096||0.1405|TWO_SIDED|80.0|-0.23|0.02||One-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.02|-0.23|0.1405
70884534|NCT01336738|141254524|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.097||0.0067|TWO_SIDED|80.0|-0.36|-0.12||One-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.12|-0.36|0.0067
70884535|NCT01336738|141254524|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.098||0.0001|TWO_SIDED|80.0|-0.5|-0.24||One-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.24|-0.50|0.0001
70963506|NCT01179672|141431926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12||||0.022|TWO_SIDED|95.0|-2.07|-0.16|||ANCOVA|ANCOVA adjusted for treatment, pooled investigator and baseline.||||-0.16|-2.07|0.022
70963507|NCT01179672|141431927|SUPERIORITY_OR_OTHER|||||||0.014||||||P-value is for ≥30% reduction in 24-hour average pain.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by pooled investigator.||||||0.014
70884536|NCT01336738|141254524|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.094||0.0002|TWO_SIDED|80.0|-0.46|-0.22||One-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.22|-0.46|0.0002
70884537|NCT01336738|141254524|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.135||0.4887|TWO_SIDED|80.0|-0.18|0.17||One-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.17|-0.18|0.4887
70884538|NCT01336738|141254524|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.137||0.002|TWO_SIDED|80.0|-0.57|-0.22||One-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.22|-0.57|0.0020
70884539|NCT01336738|141254524|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.138|<|0.0001|TWO_SIDED|80.0|-0.76|-0.41||One-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.41|-0.76|<0.0001
70963508|NCT01179672|141431927|SUPERIORITY_OR_OTHER|||||||0.006||||||P-value is for ≥50% reduction in 24-hour average pain.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by pooled investigator.||||||0.006
70963509|NCT01179672|141431927|SUPERIORITY_OR_OTHER|||||||0.193||||||P-value is for ≥75% reduction in 24-hour average pain.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by pooled investigator.||||||0.193
70884540|NCT01336738|141254524|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.133|<|0.0001|TWO_SIDED|80.0|-0.76|-0.42||One-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.42|-0.76|<0.0001
70884541|NCT01336738|141254526|SUPERIORITY_OR_OTHER||LS Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|0.225||0.2067|TWO_SIDED|95.0|-0.16|0.73||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.73|-0.16|0.2067
70884542|NCT01336738|141254526|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.224||0.8602|TWO_SIDED|95.0|-0.4|0.48||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.48|-0.40|0.8602
70884543|NCT01336738|141254526|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.225||0.92|TWO_SIDED|95.0|-0.47|0.42||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.42|-0.47|0.9200
70884544|NCT01336738|141254526|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.223||0.0399|TWO_SIDED|95.0|0.02|0.9||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.90|0.02|0.0399
70884545|NCT01336738|141254526|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.242||0.2266|TWO_SIDED|95.0|-0.18|0.77||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.77|-0.18|0.2266
70884546|NCT01336738|141254526|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.241||0.8493|TWO_SIDED|95.0|-0.43|0.52||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.52|-0.43|0.8493
70884547|NCT01336738|141254526|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.242||0.9511|TWO_SIDED|95.0|-0.49|0.46||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.46|-0.49|0.9511
70884548|NCT01336738|141254526|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.241||0.1369|TWO_SIDED|95.0|-0.11|0.83||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.83|-0.11|0.1369
70884549|NCT01336738|141254526|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.272||0.1562|TWO_SIDED|95.0|-0.15|0.92||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.92|-0.15|0.1562
70884550|NCT01336738|141254526|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.272||0.4913|TWO_SIDED|95.0|-0.72|0.35||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.35|-0.72|0.4913
70884551|NCT01336738|141254526|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.272||0.513|TWO_SIDED|95.0|-0.36|0.71||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.71|-0.36|0.5130
70884552|NCT01336738|141254526|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.269||0.0298|TWO_SIDED|95.0|0.06|1.12||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.12|0.06|0.0298
70884553|NCT01336738|141254526|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.363||0.3196|TWO_SIDED|95.0|-0.35|1.08||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.08|-0.35|0.3196
70884554|NCT01336738|141254526|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.367||0.8884|TWO_SIDED|95.0|-0.77|0.67||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.67|-0.77|0.8884
70884555|NCT01336738|141254526|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.365||0.7325|TWO_SIDED|95.0|-0.59|0.84||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.84|-0.59|0.7325
70963510|NCT01179672|141431928|SUPERIORITY_OR_OTHER|||||||0.003||||||P-value is for ≥30% reduction in 24-hour BPI-Severity average pain.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by pooled investigator.||||||0.003
70963511|NCT01179672|141431928|SUPERIORITY_OR_OTHER|||||||0.001||||||P-value is for ≥50% reduction in 24-hour BPI-Severity average pain.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by pooled investigator.||||||0.001
70884556|NCT01336738|141254526|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.357||0.3395|TWO_SIDED|95.0|-0.36|1.04||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.04|-0.36|0.3395
70884557|NCT01336738|141254526|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.41||0.7514|TWO_SIDED|95.0|-0.68|0.94||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.94|-0.68|0.7514
70884558|NCT01336738|141254526|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.413||0.7529|TWO_SIDED|95.0|-0.68|0.94||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.94|-0.68|0.7529
70884559|NCT01336738|141254526|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.411||0.9638|TWO_SIDED|95.0|-0.79|0.83||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.83|-0.79|0.9638
70884560|NCT01336738|141254526|SUPERIORITY_OR_OTHER||LS Mean Difference|0.67|STANDARD_ERROR_OF_MEAN|0.404||0.0962|TWO_SIDED|95.0|-0.12|1.47||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.47|-0.12|0.0962
70884561|NCT02970968|141254530|SUPERIORITY|||||||0.0099|||||||Mixed Models Analysis|||||||.0099
70884562|NCT02970968|141254531|SUPERIORITY|||||||0.016|||||||Mixed Models Analysis|||||||.0160
70884563|NCT02970968|141254532|SUPERIORITY|||||||0.039|||||||Mixed Models Analysis|||||||.039
70884564|NCT02970968|141254533|SUPERIORITY|||||||0.0223|||||||Mixed Models Analysis|||||||.0223
70884565|NCT02970968|141254534|SUPERIORITY|||||||0.0497|||||||Mixed Models Analysis|||||||.0497
70884566|NCT02970968|141254535|SUPERIORITY|||||||0.0207|||||||Mixed Models Analysis|||||||.0207
70884567|NCT02970968|141254536|SUPERIORITY|||||||0.0429|||||||Mixed Models Analysis|||||||.0429
70884568|NCT02970968|141254537|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
70963512|NCT01179672|141431928|SUPERIORITY_OR_OTHER|||||||0.168||||||P-value is for ≥75% reduction in 24-hour BPI-Severity average pain.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel test was stratified by pooled investigator.||||||0.168
70884569|NCT02970968|141254538|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|||||||.0003
70884570|NCT02970968|141254539|SUPERIORITY|||||||0.023|||||||Mixed Models Analysis|||||||.023
70884571|NCT02970968|141254540|SUPERIORITY|||||||0.0078|||||||Mixed Models Analysis|||||||.0078
70884572|NCT02970968|141254541|SUPERIORITY|||||||0.0294|||||||Mixed Models Analysis|||||||.0294
70884573|NCT02970968|141254542|SUPERIORITY|||||||0.0229|||||||Mixed Models Analysis|||||||.0229
70884574|NCT02970968|141254543|SUPERIORITY|||||||0.0018|||||||Mixed Models Analysis|||||||.0018
70884575|NCT02970968|141254544|SUPERIORITY|||||||0.0013|||||||Mixed Models Analysis|||||||.0013
70884576|NCT02970968|141254545|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||||||.0001
70884577|NCT02970968|141254546|SUPERIORITY|||||||0.018|||||||Mixed Models Analysis|||||||.018
70884578|NCT02970968|141254547|SUPERIORITY|||||||0.0164|||||||Mixed Models Analysis|||||||.0164
70884579|NCT02970968|141254548|SUPERIORITY|||||||0.0053|||||||Mixed Models Analysis|||||||.0053
70884580|NCT02970968|141254549|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||.0020
70884581|NCT03003520|141254552|SUPERIORITY||||||>|0.99||||||Significance defined as 0.05.|Fisher Exact|||||||>0.99
70884582|NCT03003520|141254552|SUPERIORITY||AUC-ROC|0.477||||0.872|TWO_SIDED|||||Significance defined as 0.05.|Wilcoxon (Mann-Whitney)|||The Area Under the Receiver Operator Characteristic Curve (AUC-ROC) is the estimated parameter. Responders were compared to non-responders by ranking them according to their CD8 density.||||0.872
70884583|NCT03003520|141254553|SUPERIORITY|||||||0.0403||||||Significance defined as 0.05.|Fisher Exact|||||||0.0403
70884584|NCT03003520|141254553|SUPERIORITY||AUC-ROC|0.583||||0.523|TWO_SIDED|||||Significance defined as 0.05.|Wilcoxon (Mann-Whitney)|||The Area Under the Receiver Operator Characteristic Curve (AUC-ROC) is the estimated parameter. Responders were compared to non-responders by ranking them according to their PDL1 % of total cells.||||0.523
70884585|NCT03003520|141254554|SUPERIORITY||||||>|0.99||||||Significance defined as 0.05.|Fisher Exact|||||||>0.99
70884586|NCT03003520|141254554|SUPERIORITY||AUC-ROC|0.583||||0.557|TWO_SIDED|||||Significance defined as 0.05.|Wilcoxon (Mann-Whitney)|||The Area Under the Receiver Operator Characteristic Curve (AUC-ROC) is the estimated parameter. Responders were compared to non-responders by ranking them according to their PDL1 % of tumor cells.||||0.557
70884587|NCT03003520|141254555|SUPERIORITY|||||||0.662||||||Significance defined as 0.05.|Fisher Exact|||||||0.662
70884588|NCT03003520|141254555|SUPERIORITY||AUC-ROC|0.6||||0.399|TWO_SIDED|||||Significance defined as 0.05.|Wilcoxon (Mann-Whitney)|||The Area Under the Receiver Operator Characteristic Curve (AUC-ROC) is the estimated parameter. Responders were compared to non-responders by ranking them according to their IFNG-Score.||||0.399
70884589|NCT01332149|141254558|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.148||0.0559|TWO_SIDED|95.0|-0.58|0.01||Primary analysis was two-sided and performed at the 0.05 significance level. No multiple comparisons adjustment was made.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||0.01|-0.58|0.0559
70884590|NCT01332149|141254559|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.12||0.0527|TWO_SIDED|95.0|-0.47|0.0||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 1 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.00|-0.47|0.0527
70884591|NCT01332149|141254559|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.121||0.0279|TWO_SIDED|95.0|-0.5|-0.03||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 2 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.03|-0.50|0.0279
70884592|NCT01332149|141254559|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.121||0.0508|TWO_SIDED|95.0|-0.48|0.0||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 3 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.00|-0.48|0.0508
70884593|NCT01332149|141254559|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.121||0.0349|TWO_SIDED|95.0|-0.49|-0.02||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 4 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.02|-0.49|0.0349
70884594|NCT01332149|141254559|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.122||0.0672|TWO_SIDED|95.0|-0.46|0.02||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 5 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.02|-0.46|0.0672
70884595|NCT01332149|141254559|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.122||0.0469|TWO_SIDED|95.0|-0.48|0.0||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 6 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.00|-0.48|0.0469
70884596|NCT01332149|141254559|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.122||0.028|TWO_SIDED|95.0|-0.51|-0.03||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 7 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.03|-0.51|0.0280
70884597|NCT01332149|141254559|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.122||0.014|TWO_SIDED|95.0|-0.54|-0.06||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 8 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.06|-0.54|0.0140
70884598|NCT01332149|141254559|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.122||0.0375|TWO_SIDED|95.0|-0.49|-0.01||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 9 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.01|-0.49|0.0375
70884599|NCT01332149|141254559|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.105||0.0164|TWO_SIDED|95.0|-0.46|-0.05||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis||Overall change was estimated from the mixed effect model treatment main effect.|Overall change from baseline analysis. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.05|-0.46|0.0164
70884600|NCT01332149|141254561|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.143||0.134|TWO_SIDED|95.0|-0.49|0.07||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||0.07|-0.49|0.1340
70884601|NCT01332149|141254562|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.127||0.3438|TWO_SIDED|95.0|-0.37|0.13||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 1 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.13|-0.37|0.3438
70884602|NCT01332149|141254562|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.128||0.2482|TWO_SIDED|95.0|-0.4|0.1||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 2 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.10|-0.40|0.2482
70884603|NCT01332149|141254562|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.129||0.2249|TWO_SIDED|95.0|-0.41|0.1||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 3 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.10|-0.41|0.2249
70884604|NCT01332149|141254562|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.129||0.1094|TWO_SIDED|95.0|-0.46|0.05||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 4 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.05|-0.46|0.1094
70884605|NCT01332149|141254562|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.129||0.2095|TWO_SIDED|95.0|-0.41|0.09||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 5 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.09|-0.41|0.2095
70884606|NCT01332149|141254562|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.129||0.0531|TWO_SIDED|95.0|-0.5|0.0||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 6 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.00|-0.50|0.0531
70884607|NCT01332149|141254562|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.13||0.1628|TWO_SIDED|95.0|-0.44|0.07||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 7 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.07|-0.44|0.1628
70884608|NCT01332149|141254562|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.13||0.077|TWO_SIDED|95.0|-0.48|0.02||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 8 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.02|-0.48|0.0770
70884609|NCT01332149|141254562|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.13||0.1651|TWO_SIDED|95.0|-0.43|0.07||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 9 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.07|-0.43|0.1651
70884610|NCT01332149|141254562|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.11||0.1006|TWO_SIDED|95.0|-0.4|0.04||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Overall change from baseline analysis. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.04|-0.40|0.1006
70884611|NCT01332149|141254563|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.1309|TWO_SIDED|95.0|0.93|1.74||Analysis was two-sided and performed at the 0.05 significance level.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test comparing pregabalin to placebo adjusted for center.||||1.74|0.93|0.1309
70884612|NCT01332149|141254566|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.25|STANDARD_ERROR_OF_MEAN|1.628||0.0463|TWO_SIDED|95.0|-6.45|-0.05||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||-0.05|-6.45|0.0463
70884613|NCT01332149|141254567|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.061||0.2748|TWO_SIDED|95.0|-0.19|0.05||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||0.05|-0.19|0.2748
70884614|NCT01332149|141254569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|1.577||0.4758|TWO_SIDED|95.0|-4.22|1.97||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||1.97|-4.22|0.4758
70884615|NCT01332149|141254570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.31|STANDARD_ERROR_OF_MEAN|2.22||0.1363|TWO_SIDED|95.0|-1.05|7.67||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||7.67|-1.05|0.1363
70884616|NCT01332149|141254571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|1.371||0.8808|TWO_SIDED|95.0|-2.49|2.9||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||2.90|-2.49|0.8808
70963513|NCT01179672|141431929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.001|TWO_SIDED|95.0|-0.96|-0.24|||Mixed Models Analysis|||||-0.24|-0.96|0.001
70963514|NCT01179672|141431930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26||||0.02|TWO_SIDED|95.0|-2.33|-0.2|||Mixed Models Analysis|||||-0.20|-2.33|0.020
70884617|NCT01332149|141254572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.11||0.0887|TWO_SIDED|95.0|-0.03|0.4||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||0.40|-0.03|0.0887
70884618|NCT01332149|141254573|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||0.7929|TWO_SIDED|95.0|0.72|1.53||Analysis was two-sided and performed at the 0.05 significance level.|Regression, Logistic|||Analysis performed using a logistic regression model with treatment and center as factors, and baseline value as a covariate.||1.53|0.72|0.7929
70884619|NCT01332149|141254574|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.05|STANDARD_ERROR_OF_MEAN|1.973||0.596|TWO_SIDED|95.0|-2.83|4.92||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||4.92|-2.83|0.5960
70884620|NCT01332149|141254575|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|1.536||0.8216|TWO_SIDED|95.0|-3.36|2.67||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||2.67|-3.36|0.8216
70963515|NCT02748018|141431932|SUPERIORITY|Test of Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|-0.8|||||ONE_SIDED|97.5||-0.4||||||||-0.4||
70963516|NCT02748018|141431933|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-4.9|||||ONE_SIDED|97.5||-3.6||||||||-3.6||
70963517|NCT02748018|141431934|SUPERIORITY|Test of Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|-0.7|||||ONE_SIDED|97.5||-0.3||||||||-0.3||
70963518|NCT02748018|141431935|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-4.8|||||ONE_SIDED|97.5||-3.1||||||||-3.1||
70963519|NCT02748018|141431936|SUPERIORITY|Test of Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|0.0|||||ONE_SIDED|97.5||0.3||||||||0.3||
70884621|NCT01332149|141254576|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.177||0.4829|TWO_SIDED|95.0|-3.14|1.49||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||1.49|-3.14|0.4829
70884622|NCT01332149|141254577|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.073||0.0431|TWO_SIDED|95.0|-0.29|0.0||Analysis was two-sided and performed at the 0.05 significance level.|ANOVA|||Analysis performed using a general linear model with treatment and center as factors.||-0.00|-0.29|0.0431
70884623|NCT01332149|141254578|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.074||0.0602|TWO_SIDED|95.0|-0.28|0.01||Analysis was two-sided and performed at the 0.05 significance level.|ANOVA|||Analysis performed using a general linear model with treatment and center as factors.||0.01|-0.28|0.0602
70884624|NCT01332149|141254580|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.207||0.4172|TWO_SIDED|95.0|-0.57|0.24||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||0.24|-0.57|0.4172
70884625|NCT01332149|141254581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.218||0.3724|TWO_SIDED|95.0|-0.62|0.23||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||0.23|-0.62|0.3724
70884626|NCT01920932|141254592|SUPERIORITY||Binomial proportions|31.25|||||TWO_SIDED|90.0||||The comparison of the complete rate between the first 32 evaluable participants and the historical control of HOD99 unfavorable risk patients was estimated by the binomial proportions test.||||In the historical control (HOD99) 17% of patients had CR at week 8. Sample size for this objective is calculated based on a binomial distribution to test H0: p=17% vs. Ha: p\>17%, where p is the true CR rate after 2 cycles of AEPA. 32 patients are needed to detect 20% increase of CR rate with 80% power and 5% type I error. If it shows efficacy, the response results will be reported, and the study will continue to enroll for a total of 77 patients to assess response and EFS.||||
70884627|NCT01920932|141254594|SUPERIORITY|||||||0.004|||||||Fisher Exact|||Comparison of proportion of patient's complete response rate between HLHR13 and HOD99 (NCT00145600) unfavorable risk arm 2 (UR2).||||0.004
70884628|NCT01920932|141254595|SUPERIORITY|||||||0.0008|||||||Log Rank|||The comparison of the EFS between HLHR13 and historical control of HOD99 unfavorable risk 2 arm (UR2) was done by the two-sample log-rank test.||||0.0008
70884629|NCT01920932|141254600|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Total Score-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||<.001
70884630|NCT01920932|141254600|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Total Score-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.002
70884631|NCT01920932|141254600|SUPERIORITY|||||||0.067|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Total Score-T4, completion of radiation (approximately 8 months)||||0.067
70884632|NCT01920932|141254600|SUPERIORITY|||||||0.115|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Pain and Hurt-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.115
70884633|NCT01920932|141254600|SUPERIORITY|||||||0.455|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Pain and Hurt-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.455
70884634|NCT01920932|141254600|SUPERIORITY|||||||0.636|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Pain and Hurt-T4, completion of radiation (approximately 8 months)||||0.636
70963520|NCT02748018|141431937|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-1.0|||||ONE_SIDED|97.5||-0.2||||||||-0.2||
70884635|NCT01920932|141254600|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Nausea-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||<.001
70884636|NCT01920932|141254600|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Nausea-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||<.001
70884637|NCT01920932|141254600|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Nausea-T4, completion of radiation (approximately 8 months)||||0.006
70884638|NCT01920932|141254600|SUPERIORITY|||||||0.099|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Procedural Anxiety-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.099
70884639|NCT01920932|141254600|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Procedural Anxiety-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.050
70884640|NCT01920932|141254600|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Procedural Anxiety-T4, completion of radiation (approximately 8 months)||||0.520
70884641|NCT01920932|141254600|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Treatment Anxiety-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.024
70884642|NCT01920932|141254600|SUPERIORITY|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Treatment Anxiety-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.011
70884643|NCT01920932|141254600|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Treatment Anxiety-T4, completion of radiation (approximately 8 months)||||0.009
70884644|NCT01920932|141254600|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Worry-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||<.001
70884645|NCT01920932|141254600|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Worry-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||<.001
70884646|NCT01920932|141254600|SUPERIORITY|||||||0.035|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Worry-T4, completion of radiation (approximately 8 months)||||0.035
70884647|NCT01920932|141254600|SUPERIORITY|||||||0.037|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Cognitive Problems-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.037
70884648|NCT01920932|141254600|SUPERIORITY|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Cognitive Problems-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.043
70884649|NCT01920932|141254600|SUPERIORITY|||||||0.044|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Cognitive Problems-T4, completion of radiation (approximately 8 months)||||0.044
70884650|NCT01920932|141254600|SUPERIORITY|||||||0.091|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Perceived Physical Appearance-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.091
70884651|NCT01920932|141254600|SUPERIORITY|||||||0.248|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Perceived Physical Appearance-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.248
70884652|NCT01920932|141254600|SUPERIORITY|||||||0.069|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Perceived Physical Appearance-T4, completion of radiation (approximately 8 months)||||0.069
70884653|NCT01920932|141254600|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Communication-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.010
70884654|NCT01920932|141254600|SUPERIORITY|||||||0.292|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Communication-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.292
70884655|NCT01920932|141254600|SUPERIORITY|||||||0.429|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Communication-T4, completion of radiation (approximately 8 months)||||0.429
70884656|NCT01920932|141254601|SUPERIORITY|||||||0.975|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Total Score-T1, At Diagnosis (baseline)||||0.975
70884657|NCT01920932|141254601|SUPERIORITY|||||||0.032|||||||t-test, 2 sided|||PedsQL v.4.0 Total Score-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.032
70884658|NCT01920932|141254601|SUPERIORITY|||||||0.497|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Total Score-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.497
70963521|NCT02748018|141431938|NON_INFERIORITY|Non-inferiority margin: 2%. Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-2.2|||||ONE_SIDED|97.5||-0.9||||||||-0.9||
70963522|NCT02748018|141431939|NON_INFERIORITY|Non-inferiority margin: 0.4%. Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|-0.3|||||ONE_SIDED|97.5||-0.1||||||||-0.1||
70884659|NCT01920932|141254601|SUPERIORITY|||||||0.399|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Total Score-T4, completion of radiation (approximately 8 months)||||0.399
70884660|NCT01920932|141254601|SUPERIORITY|||||||0.451|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Physical Functioning-T1, At Diagnosis (baseline)||||0.451
70884661|NCT01920932|141254601|SUPERIORITY|||||||0.198|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Physical Functioning-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.198
70884662|NCT01920932|141254601|SUPERIORITY|||||||0.967|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Physical Functioning-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.967
70884663|NCT01920932|141254601|SUPERIORITY|||||||0.647|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Physical Functioning-T4, completion of radiation (approximately 8 months)||||0.647
70884664|NCT01920932|141254601|SUPERIORITY|||||||0.145|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Emotional Functioning-T1, At Diagnosis (baseline)||||0.145
70963523|NCT02748018|141431940|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%) During Night|Mean Difference (Final Values)|-5.4|||||ONE_SIDED|97.5||-3.7||||||||-3.7||
70884665|NCT01920932|141254601|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Emotional Functioning-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||<.001
70884666|NCT01920932|141254601|SUPERIORITY|||||||0.073|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Emotional Functioning-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.073
70884667|NCT01920932|141254601|SUPERIORITY|||||||0.156|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Emotional Functioning-T4, completion of radiation (approximately 8 months)||||0.156
70884668|NCT01920932|141254601|SUPERIORITY|||||||0.844|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Social Functioning-T1, At Diagnosis (baseline)||||0.844
70884669|NCT01920932|141254601|SUPERIORITY|||||||0.206|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Social Functioning-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.206
70884670|NCT01920932|141254601|SUPERIORITY|||||||0.491|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Social Functioning-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.491
70884671|NCT01920932|141254601|SUPERIORITY|||||||0.906|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Social Functioning-T4, completion of radiation (approximately 8 months)||||0.906
70884672|NCT01920932|141254601|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 School Functioning-T1, At Diagnosis (baseline)||||0.580
70884673|NCT01920932|141254601|SUPERIORITY|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 School Functioning-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.012
70884674|NCT01920932|141254601|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 School Functioning-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.010
70884675|NCT01920932|141254601|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 School Functioning-T4, completion of radiation (approximately 8 months)||||0.005
70884676|NCT02643251|141254711|SUPERIORITY|||||||0.3361|||||||Mixed Models Analysis|||||||0.3361
70884677|NCT02365636|141254719|SUPERIORITY||LSM difference from placebo|0.32||||0.13|TWO_SIDED|95.0|-0.094|0.726||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the daily average NRS scores at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the daily average NRS scores as covariate; and patient as a random effect.||0.726|-0.094|0.130
70884678|NCT02365636|141254719|SUPERIORITY||LSM difference from placebo|0.24||||0.245|TWO_SIDED|95.0|-0.167|0.652||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the daily average NRS scores at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the daily average NRS scores as covariate; and patient as a random effect.||0.652|-0.167|0.245
70884679|NCT02365636|141254720|SUPERIORITY||LSM difference from placebo|0.32||||0.128|TWO_SIDED|95.0|-0.093|0.735||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the average NRS pain scores recorded in the evening at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the average NRS pain scores recorded in the evening as covariate; and patient as a random effect.||0.735|-0.093|0.128
70963524|NCT02748018|141431941|SUPERIORITY|Test of Treatment Effect on Time in Target Range (%) During Night|Mean Difference (Final Values)|18.8|||||ONE_SIDED|97.5|14.5||||||||||14.5|
70963525|NCT02748018|141431942|SUPERIORITY|Test of Treatment Effect on Time in Target Range (%)|Mean Difference (Final Values)|12.0|||||ONE_SIDED|97.5|8.8||||||||||8.8|
70884680|NCT02365636|141254720|SUPERIORITY||LSM difference from placebo|0.27||||0.194|TWO_SIDED|95.0|-0.14|0.688||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the average NRS pain scores recorded in the evening at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the average NRS pain scores recorded in the evening as covariate; and patient as a random effect.||0.688|-0.140|0.194
70884681|NCT02365636|141254721|SUPERIORITY||LSM difference from placebo|0.28||||0.177|TWO_SIDED|95.0|-0.128|0.691||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the average NRS pain scores recorded in the morning at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the average NRS pain scores recorded in the morning as covariate; and patient as a random effect.||0.691|-0.128|0.177
70884682|NCT02365636|141254721|SUPERIORITY||LSM difference from placebo|0.2||||0.325|TWO_SIDED|95.0|-0.204|0.614||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the average NRS pain scores recorded in the morning at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the average NRS pain scores recorded in the morning as covariate; and patient as a random effect.||0.614|-0.204|0.325
70884683|NCT02365636|141254722|SUPERIORITY||LSM difference from placebo|0.29||||0.202|TWO_SIDED|95.0|-0.158|0.741||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the worst NRS pain scores recorded in the evening at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the worst NRS pain scores recorded in the evening as covariate; and patient as a random effect.||0.741|-0.158|0.202
70884684|NCT02365636|141254722|SUPERIORITY||LSM difference from placebo|0.457||||0.457|TWO_SIDED|95.0|-0.28|0.621||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the worst NRS pain scores recorded in the evening at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the worst NRS pain scores recorded in the evening as covariate; and patient as a random effect.||0.621|-0.280|0.457
70884685|NCT02365636|141254723|SUPERIORITY||Odds Ratio (OR)|0.92||||0.815|TWO_SIDED|95.0|0.456|1.856||5% level of significance|Regression, Logistic|||\>=30% improvement. P-value, odds ratio and CI for odds ratio are calculated using logistic model including response (yes/no) as dependent variable, treatment group and pooled study sites as factors.||1.856|0.456|0.815
70884686|NCT02365636|141254723|SUPERIORITY||Odds Ratio (OR)|1.05||||0.893|TWO_SIDED|95.0|0.52|2.117||5% level of significance|Regression, Logistic|||\>=30% improvement. P-value, odds ratio and CI for odds ratio are calculated using logistic model including response (yes/no) as dependent variable, treatment group and pooled study sites as factors.||2.117|0.520|0.893
70963526|NCT02748018|141431943|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-3.6|||||ONE_SIDED|97.5||-2.6||||||||-2.6||
70963527|NCT02748018|141431944|SUPERIORITY|Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|-0.6|||||ONE_SIDED|97.5||-0.3||||||||-0.3||
70884687|NCT02365636|141254723|SUPERIORITY||Odds Ratio (OR)|0.74||||0.43|TWO_SIDED|95.0|0.357|1.55||5% level of significance|Regression, Logistic|||\>=50% improvement. P-value, odds ratio and CI for odds ratio are calculated using logistic model including response (yes/no) as dependent variable, treatment group and pooled study sites as factors.||1.550|0.357|0.430
70884688|NCT02365636|141254723|SUPERIORITY||Odds Ratio (OR)|1.02||||0.967|TWO_SIDED|95.0|0.494|2.088||5% level of significance|Regression, Logistic|||\>=50% improvement. P-value, odds ratio and CI for odds ratio are calculated using logistic model including response (yes/no) as dependent variable, treatment group and pooled study sites as factors.||2.088|0.494|0.967
70884689|NCT02365636|141254724|SUPERIORITY||LSM of difference with placebo|2.2||||0.251|TWO_SIDED|95.0|-1.55|5.92||5% level of significance|mixed model for repeated measures|||Change from baseline at Week 2 The MMRM used pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||5.92|-1.55|0.251
70884690|NCT02365636|141254724|SUPERIORITY||LSM difference from placebo|1.3||||0.495|TWO_SIDED|95.0|-2.46|5.07||5% level of significance|mixed model for repeated measures|||Change from baseline at Week 2. The MMRM used pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||5.07|-2.46|0.495
70884691|NCT02365636|141254724|SUPERIORITY||LSM difference from placebo|3.1||||0.123|TWO_SIDED|95.0|-0.84|7.06||5% level of significance|mixed model for repeated measures|||Change from baseline at Week 4. The MMRM used pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||7.06|-0.84|0.123
70963528|NCT02748018|141431945|NON_INFERIORITY|Non-inferiority margin: 2%. Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-3.6|||||ONE_SIDED|97.5||-1.9||||||||-1.9||
70884692|NCT02365636|141254724|SUPERIORITY||LSM difference from placebo|2.8||||0.16|TWO_SIDED|95.0|-1.12|6.77||5% level of significance.|miex model for repeated measures|||Change from baseline at Week 4. The MMRM used pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||6.77|-1.12|0.160
70963529|NCT02748018|141431946|NON_INFERIORITY|Non-inferiority margin: 0.4%. Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|0.1|||||ONE_SIDED|97.5||0.3||||||||0.3||
70963530|NCT02748018|141431947|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%) during Night|Mean Difference (Final Values)|-7.3|||||ONE_SIDED|97.5||-4.7||||||||-4.7||
70963531|NCT02748018|141431948|SUPERIORITY|Test of Treatment Effect on Time in Target Range (%) during Night|Mean Difference (Final Values)|15.9|||||ONE_SIDED|97.5|11.1||||||||||11.1|
70963532|NCT02748018|141431949|SUPERIORITY|Test of Treatment Effect on Time in Target Range (%)|Mean Difference (Final Values)|13.6|||||ONE_SIDED|97.5|9.9||||||||||9.9|
70963533|NCT02748018|141431950|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-4.3|||||ONE_SIDED|97.5||-3.1||||||||-3.1||
70963534|NCT02748018|141431951|SUPERIORITY|Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|-0.2|||||ONE_SIDED|97.5||0.0||||||||0.0||
70963535|NCT02748018|141431952|NON_INFERIORITY|Non-inferiority margin: 2%. Treatment Effect on Time in Hypoglycemic Range (%) with Multiple Imputation|Mean Difference (Final Values)|-0.3|||||ONE_SIDED|97.5||0.7||||||||0.7||
70963536|NCT02748018|141431953|NON_INFERIORITY|Non-inferiority margin: 0.4%. Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|0.0|||||ONE_SIDED|97.5||0.1||||||||0.1||
70963537|NCT02748018|141431954|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%) during Night|Mean Difference (Final Values)|-0.7|||||ONE_SIDED|97.5||0.2||||||||0.2||
70963538|NCT02748018|141431955|SUPERIORITY|Test of Treatment Effect on Time in Target Range (%) during Night|Mean Difference (Final Values)|12.2|||||ONE_SIDED|97.5|8.3||||||||||8.3|
70963539|NCT02748018|141431956|SUPERIORITY|Test of Treatment Effect on Time in Target Range (%)|Mean Difference (Final Values)|6.3|||||ONE_SIDED|97.5|3.3||||||||||3.3|
70963540|NCT02748018|141431957|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-0.8|||||ONE_SIDED|97.5||-0.1||||||||-0.1||
70963541|NCT02748018|141431958|SUPERIORITY|Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|0.0|||||ONE_SIDED|97.5||0.1||||||||0.1||
70963542|NCT00578786|141431979|SUPERIORITY_OR_OTHER||Mean Difference (Net)|38.0|STANDARD_DEVIATION|74.28|||TWO_SIDED|95.0|22.7|53.3|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||53.3|22.7|
70884693|NCT02365636|141254725|SUPERIORITY||LSM difference from placebo|1.3||||0.609|TWO_SIDED|95.0|-3.81|6.48||5% level of significance|ANCOVA|ANCOVA model includes study center, treatment, and baseline.||||6.48|-3.81|0.609
70884694|NCT02365636|141254725|SUPERIORITY||LSM difference with placebo|2.1||||0.427|TWO_SIDED|95.0|-3.05|7.19||5% level of significance|ANCOVA|ANCOVA model includes study center, treatment, and baseline.||||7.19|-3.05|0.427
70884695|NCT02365636|141254726|SUPERIORITY||LSM difference from placebo|0.2||||0.166|TWO_SIDED|95.0|-0.07|0.43||5% level of significance|mixed model for repeated measures|||Week 2 Mixed model for repeated measures (MMRM) with pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||0.43|-0.07|0.166
70884696|NCT02365636|141254726|SUPERIORITY||LSM difference from placebo|0.3||||0.046|TWO_SIDED|95.0|0.0|0.51||5% level of significance|mixed model for repeated measures|||Week 2 Mixed model for repeated measures (MMRM) with pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||0.51|0.00|0.046
70884697|NCT02365636|141254726|SUPERIORITY||LSM difference from placebo|0.2||||0.152|TWO_SIDED|95.0|-0.08|0.53||5% level of significance|mixed model for repeated measures|||Week 4 Mixed model for repeated measures (MMRM) with pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||0.53|-0.08|0.152
70884698|NCT02365636|141254726|SUPERIORITY||LSM difference from placebo|0.1||||0.342|TWO_SIDED|95.0|-0.16|0.46||5% level of significance|mixed model for repeated measures|||Week 4 Mixed model for repeated measures (MMRM) with pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||0.46|-0.16|0.342
70884699|NCT02365636|141254727|SUPERIORITY||LSM difference from placebo|0.2||||0.311|TWO_SIDED|95.0|-0.22|0.7||5% level of significance|mixed model for repeated measures|||Change from baseline at Week 2 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.70|-0.22|0.311
70884700|NCT02365636|141254727|SUPERIORITY||LSM difference from placebo|0.3||||0.262|TWO_SIDED|95.0|-0.2|0.73||5% level of significance|mixed model for repeated measures|||Change from baseline at week 2 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.73|-0.20|0.262
70884701|NCT02365636|141254727|SUPERIORITY||LSM difference from placebo|0.5||||0.065|TWO_SIDED|95.0|-0.03|0.97||5% level of significance|mixed model for repeated measures|||Change from baseline at week 4 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.97|-0.03|0.065
70963543|NCT00578786|141431979|SUPERIORITY_OR_OTHER||Mean Difference (Net)|32.5|STANDARD_DEVIATION|78.55|||TWO_SIDED|95.0|21.1|43.8|||||Applies to Ambrisentan 5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||43.8|21.1|
70963544|NCT00578786|141431979|SUPERIORITY_OR_OTHER||Mean Difference (Net)|40.9|STANDARD_DEVIATION|72.85|||TWO_SIDED|95.0|26.1|55.7|||||Applies to Ambrisentan 10 mg group only. LOCF method of imputation. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||55.7|26.1|
70963545|NCT00578786|141431979|SUPERIORITY_OR_OTHER||Mean Difference (Net)|36.0|STANDARD_DEVIATION|75.97|||TWO_SIDED|95.0|28.3|43.7|||||Applies to Ambrisentan combined group only. LOCF method of imputation.|||43.7|28.3|
70963546|NCT00578786|141431980|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.9|STANDARD_DEVIATION|96.14|||TWO_SIDED|95.0|5.1|44.7|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||44.7|5.1|
70963547|NCT00578786|141431980|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.9|STANDARD_DEVIATION|94.5|||TWO_SIDED|95.0|14.2|41.6|||||Applies to Ambrisentan 5.0 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||41.6|14.2|
70963548|NCT00578786|141431980|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.2|STANDARD_DEVIATION|72.97|||TWO_SIDED|95.0|22.4|52.0|||||Applies to Ambrisentan 10 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||52.0|22.4|
70884702|NCT02365636|141254727|SUPERIORITY||LSM difference from placebo|0.3||||0.296|TWO_SIDED|95.0|-0.23|0.76||5% level of significance|mixed model for repeated measures|||Change from baseline at week 4 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.76|-0.23|0.296
70884703|NCT02365636|141254728|SUPERIORITY|||||||0.245||||||5% level of significance|Regression, Cox|||||||0.245
70884704|NCT02365636|141254728|SUPERIORITY|||||||0.304||||||5% level of significance|Regression, Cox|||||||0.304
70884705|NCT02365636|141254729|SUPERIORITY||LSM difference from placebo|-0.1||||0.556|TWO_SIDED|95.0|-0.61|0.33||5% level of significance|mixed model for repeated measures|||Change from baseline at week 2 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.33|-0.61|0.556
70884706|NCT02365636|141254729|SUPERIORITY||LSM difference from placebo|-0.2||||0.482|TWO_SIDED|95.0|-0.65|0.31||5% level of significance|mixed model for repeated measures|||Change from baseline at week 2 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.31|-0.65|0.482
70884707|NCT02365636|141254729|SUPERIORITY||LSM difference from placebo|-0.3||||0.333|TWO_SIDED|95.0|-0.81|0.28||5% level of significance|mixed model for repeated measures|||Change from baseline at week 4. The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.28|-0.81|0.333
70884708|NCT02365636|141254729|SUPERIORITY||LSM difference from placebo|-0.1||||0.833|TWO_SIDED|95.0|-0.62|0.5||5% level of significance|mixed model for repeated measures|||Change from baseline at week 4 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.50|-0.62|0.833
70884709|NCT02365636|141254730|SUPERIORITY||LSM difference from placebo|-0.2||||0.563|TWO_SIDED|95.0|-0.75|0.41||5% level of significance|mixed model for repeated measures|||Change from baseline at week 2 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.41|-0.75|0.563
70884710|NCT02365636|141254730|SUPERIORITY||LSM difference from placebo|-0.1||||0.804|TWO_SIDED|95.0|-0.64|0.5||5% level of significance|mixed model for repeated measures|||Change from baseline at week 2. The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.50|-0.64|0.804
70884711|NCT02365636|141254730|SUPERIORITY||LSM difference from placebo|0.1||||0.714|TWO_SIDED|95.0|-0.49|0.71||5% level of significance|mixed model for repeated measures|||Change from baseline at week 4 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.71|-0.49|0.714
70884712|NCT02365636|141254730|SUPERIORITY||LSM difference from placebo|0.0||||0.871|TWO_SIDED|95.0|-0.64|0.55||5% level of siignificance|mixed model for repeated measures|||Change from baseline at week 4. The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.55|-0.64|0.871
70884713|NCT02506816|141254765|OTHER|The P-valor Wilcoxon method is a non-parametric statistical hypothesis test used to evaluate changes from baseline H-score values of the three biomarkers.||||||0.033||||||In order to adjust the multiple comparisons made, Benjamini-Hochberg's false discovery rate (FDR) 10% method was used.|Wilcoxon (Mann-Whitney)|||After having analyzed the H-score for each of 3 biomarkers, we calculated the change from baseline subtracting post-treatment H-score from baseline H-score. Data were expressed as mean value and relative standard deviation.||||0.033
70884714|NCT02506816|141254766|OTHER|The differences in the change from baseline of different biomarkers were evaluated by the P-valor Wilcoxon method, a non-parametric statistical hypothesis test.||||||0.03||||||In order to adjust the multiple comparisons made, Benjamini-Hochberg's false discovery rate (FDR) 10% method was used.|Wilcoxon (Mann-Whitney)|||After having analyzed the H-score for each of several biomarkers, we calculated the change from baseline subtracting post-treatment H-score from baseline H-score. Data were expressed as mean value and relative standard deviation.||||0.03
70884715|NCT01236196|141254771|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Mixed Models Analysis|||||||0.11
70884716|NCT01236196|141254772|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||0.80
70884717|NCT01236196|141254773|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.01
70884718|NCT01236196|141254774|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Mixed Models Analysis|||||||0.09
70884719|NCT02281552|141254793|NON_INFERIORITY|Non-inferiority of tofacitinib MR 11 mg QD to IR 5 mg BID was concluded if the upper bound of the 2-sided 95% confidence interval of differences between the treatment groups (MR 11 mg QD - IR 5 mg BID) at Week 12 was less than the pre-specified non-inferiority margin of 0.6.|Least Square (LS) mean difference|0.43|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.17|0.69||||||Analysis was conducted using a linear mixed effect model with repeated measures (MMRM), which included treatment (tofacitinib MR 11 mg QD and IR 5 mg BID), visit, and treatment by visit interaction as fixed effects and participants as a random effect.||0.69|0.17|
70884720|NCT02540954|141254814|NON_INFERIORITY|Non-inferiority margin is 5 letters.|Least squares mean difference|0.22|||<|0.0001|TWO_SIDED|95.0|-1.51|1.96|||ANCOVA|||||1.96|-1.51|< 0.0001
70884721|NCT02540954|141254815|NON_INFERIORITY|Non inferiority margin is 7%.|Treatment difference in %|1.1|||||TWO_SIDED|95.0|-3.7|6.0||||||||6.0|-3.7|
70884722|NCT02540954|141254820|OTHER||Mean Difference (Final Values)|-1.88|||||TWO_SIDED|95.0|-4.152|0.392||||||||0.392|-4.152|
70884723|NCT01393743|141254822|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-30.81||||0.0001|TWO_SIDED|95.0|-45.49|-15.244||The P-value is based on a rank analysis of covariance with treatment and pooled country as factors, and prerandomization seizure frequency as a covariate.|ANCOVA|||The median difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.||-15.244|-45.49|0.0001
70884724|NCT01393743|141254823|SUPERIORITY_OR_OTHER|||||||0.0019||||||The P value is based on non-missing values and is from a Cochran-Mantel-Haenszel test stratified by pooled country.|Cochran-Mantel-Haenszel|||||||0.0019
70884725|NCT01393743|141254825|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-23.45||||0.0018|TWO_SIDED|95.0|-40.668|-8.518||The P value is based on a rank analysis of covariance with treatment and pooled country as factors, and prerandomization seizure frequency as a covariate.|ANCOVA|||The median difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.||-8.518|-40.668|0.0018
70884726|NCT01393743|141254826|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-12.25||||0.3478|TWO_SIDED|95.0|-53.054|26.989||The P value is based on a rank analysis of covariance with treatment and pooled country as factors, and prerandomization seizure frequency as a covariate.|ANCOVA||The median difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.|Median Difference to Placebo for Absence Seizures||26.989|-53.054|0.3478
70884727|NCT01393743|141254826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.87||||0.61|TWO_SIDED|95.0|-15.338|59.938|||ANCOVA|||Median Difference to Placebo for Myoclonic Seizure||59.938|-15.338|0.61
70884728|NCT01393743|141254827|SUPERIORITY_OR_OTHER|||||||0.1826||||||The P value is based on non-missing values and is from a Cochran-Mantel-Haenszel test stratified by pooled country.|Cochran-Mantel-Haenszel|||||||0.1826
70884729|NCT01393743|141254828|SUPERIORITY_OR_OTHER|||||||0.4653|||||||Cochran-Mantel-Haenszel|||P Value Compared to Placebo for Absence Seizures||||0.4653
70884730|NCT01393743|141254828|SUPERIORITY_OR_OTHER|||||||0.3694|||||||Cochran-Mantel-Haenszel|||P Value Compared to Placebo for Myoclonic Seizures||||0.3694
70884731|NCT02321462|141254843|NON_INFERIORITY|Non-inferiority would be demonstrated if the lower limit of the 95% confidence intervals (CI) of the difference was higher than the predefined noninferiority margin (-15%).|Adjusted difference|-0.46|||||TWO_SIDED|95.0|-4.22|3.29|||||To investigate noninferiority of Eziclen compared to Fortrans®, the adjusted difference between these 2 groups was calculated with 95% CI of the adjusted difference.|A multivariate logistic regression model, adjusted on centre, age class (≤65; \>65), gender and IBD status (No IBD, IBD) was used.||3.29|-4.22|
70884732|NCT02321462|141254844|SUPERIORITY||Adjusted difference|0.15|||=|0.0249|TWO_SIDED|95.0|0.02|0.28|||ANOVA|A 2-way analysis of variance model (ANOVA) with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||Treatment difference for Right Colon BBPS Score.||0.28|0.02|=0.0249
70884733|NCT02321462|141254844|SUPERIORITY||Adjusted difference|0.11|||=|0.0382|TWO_SIDED|95.0|0.01|0.22|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||Treatment difference for Transverse Colon BBPS Score.||0.22|0.01|=0.0382
70884734|NCT02321462|141254844|SUPERIORITY||Adjusted difference|0.06|||=|0.2538|TWO_SIDED|95.0|-0.04|0.16|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||Treatment difference for Left Colon BBPS Score.||0.16|-0.04|=0.2538
70884735|NCT02321462|141254844|SUPERIORITY||Adjusted difference|0.33|||=|0.0256|TWO_SIDED|95.0|0.04|0.62|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||Treatment difference for Global BBPS Score.||0.62|0.04|=0.0256
70884736|NCT02321462|141254845|SUPERIORITY||Adjusted difference|0.11|||=|0.084|TWO_SIDED|95.0|-0.02|0.24|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||Treatment difference for Right Colon BBPS Score (per protocol population).||0.24|-0.02|=0.0840
70884737|NCT02321462|141254845|SUPERIORITY||Treatment difference|0.08|||=|0.132|TWO_SIDED|95.0|-0.02|0.18|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||Treatment difference for Transverse Colon BBPS Score (per protocol population).||0.18|-0.02|=0.1320
70884738|NCT02321462|141254846|SUPERIORITY||Adjusted difference|-6.94|||=|0.2199|TWO_SIDED|95.0|-17.53|3.64|||Regression, Logistic|A multivariate logistic regression model, adjusted on centre, age class (≤65; \>65), gender and IBD status was used.||Treatment difference for detection of polyps.||3.64|-17.53|=0.2199
70884739|NCT02321462|141254846|SUPERIORITY||Adjusted difference|1.87|||=|0.6325|TWO_SIDED|95.0|-6.25|9.99|||Regression, Logistic|A multivariate logistic regression model, adjusted on centre, age class (≤65; \>65), gender and IBD status was used.||Treatment difference for detection of adenomas.||9.99|-6.25|=0.6325
70884740|NCT02321462|141254846|SUPERIORITY||Adjusted difference|-1.55|||=|0.7086|TWO_SIDED|95.0|-9.64|6.54|||Regression, Logistic|A multivariate logistic regression model, adjusted on centre, age class (≤65; \>65), gender and IBD status was used.||Treatment difference for detection of other lesions.||6.54|-9.64|=0.7086
70884741|NCT02321462|141254847|SUPERIORITY||Adjusted difference|0.01|||=|0.9927|TWO_SIDED|95.0|-3.12|3.14|||Regression, Logistic|A multivariate logistic regression model, adjusted on centre, age class (≤65; \>65), gender and IBD status was used.||||3.14|-3.12|=0.9927
70884742|NCT02321462|141254848|SUPERIORITY||Adjusted difference|-0.3|||=|0.7039|TWO_SIDED|95.0|-1.88|1.27|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||||1.27|-1.88|=0.7039
70884743|NCT02321462|141254849|SUPERIORITY||Adjusted difference|0.1|||=|0.1891|TWO_SIDED|95.0|-0.05|0.25|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||||0.25|-0.05|=0.1891
70884744|NCT02321462|141254850|SUPERIORITY||Adjusted difference|13.35|||=|0.0011|TWO_SIDED|95.0|6.37|20.32|||Regression, Logistic|A multivariate logistic regression model, adjusted on centre, age class (≤65; \>65), gender and IBD status was used.||||20.32|6.37|=0.0011
70884745|NCT05409235|141254873|SUPERIORITY||difference in percentage of participants|-1.064||||0.573|TWO_SIDED|90.0|-10.578|8.449|||Mantel Haenszel|MH test is adjusted for the randomization stratification factor (Screening DRSS score 47 or 53 or 61B).|A single imputation (non-response) when applying composite variable strategy. MI based for missing data at Week 24, assuming MAR when applying hypothetical strategy. Kept in the analysis when applying treatment policy strategy.|The study was powered to provide a 90% probability to detect a 20% difference between each treatment arm and the combined vehicle control.||8.449|-10.578|0.5730
70884746|NCT05409235|141254873|SUPERIORITY||difference in percentage of participants|-1.152||||0.575|TWO_SIDED|90.0|-11.178|8.874|||Mantel Haenszel|||||8.874|-11.178|0.5750
70884747|NCT05409235|141254874|SUPERIORITY||difference in percentage of participants|3.119||||0.7276|TWO_SIDED|90.0|-5.314|11.592|||Mantel Haenszel|||||11.592|-5.314|0.7276
70884748|NCT05409235|141254874|SUPERIORITY||difference in percentage of participants|5.779||||0.8492|TWO_SIDED|90.0|-3.424|14.982|||Mantel Haenszel|||||14.982|-3.424|0.8492
70884749|NCT05409235|141254875|SUPERIORITY||difference in percentage of participants|-1.863||||0.3097|TWO_SIDED|90.0|-8.036|4.309|||Mantel Haenszel|||||4.309|-8.036|0.3097
70884750|NCT05409235|141254875|SUPERIORITY||difference in percentage of participants|-1.596||||0.3414|TWO_SIDED|90.0|-8.021|4.829|||Mantel Haenszel|||||4.829|-8.021|0.3414
70884751|NCT05409235|141254876|SUPERIORITY||Cox Proportional Hazard|0.899||||0.397|TWO_SIDED|90.0|0.4378|1.8467|||Log Rank|||||1.8467|0.4378|0.397
70884752|NCT05409235|141254876|SUPERIORITY||Cox Proportional Hazard|1.113||||0.605|TWO_SIDED|90.0|0.5596|2.2117|||Log Rank|||||2.2117|0.5596|0.605
70884753|NCT05409235|141254877|SUPERIORITY||difference in percentage of participants|-10.622||||0.0619|TWO_SIDED|90.0|-21.972|0.728|||Mantel Haenszel|||||0.728|-21.972|0.0619
70884754|NCT05409235|141254877|SUPERIORITY||difference in percentage of participants|-4.942||||0.2483|TWO_SIDED|90.0|-16.897|7.013|||Mantel Haenszel|||||7.013|-16.897|0.2483
70884755|NCT05409235|141254878|SUPERIORITY||Cox Proportional Hazard|0.807||||0.237|TWO_SIDED|90.0|0.4675|1.392|||Log Rank|||||1.3920|0.4675|0.237
70884756|NCT05409235|141254878|SUPERIORITY||Cox Proportional Hazard|1.279||||0.766|TWO_SIDED|90.0|0.7795|2.0981|||Log Rank|||||2.0981|0.7795|0.766
70884757|NCT05409235|141254879|SUPERIORITY||difference in percentage of participants|-6.389||||0.2022|TWO_SIDED|90.0|-18.994|6.215|||Mantel Haenszel|||||6.215|-18.994|0.2022
70884758|NCT05409235|141254879|SUPERIORITY||difference in percentage of participants|-1.043||||0.4476|TWO_SIDED|90.0|-14.07|11.984|||Mantel Haenszel|||||11.984|-14.070|0.4476
70884759|NCT05409235|141254880|SUPERIORITY||Hazard Ratio (HR)|0.843||||0.268|TWO_SIDED|90.0|0.533|1.334||log-rank test stratified by randomization stratification factor|Log Rank|||||1.334|0.533|0.268
70884760|NCT05409235|141254880|SUPERIORITY||Hazard Ratio (HR)|1.145||||0.304|TWO_SIDED|90.0|0.738|1.775|||Log Rank|||||1.775|0.738|0.304
70884761|NCT05409235|141254881|SUPERIORITY||Odds Ratio (OR)|1.102||||0.428|TWO_SIDED|90.0|0.4573|2.657|||odds ratio|Odds ratio and p-value are from a proportional odds model with covariates for treatment group and the randomization stratification factor||||2.6570|0.4573|0.428
70884762|NCT05409235|141254881|SUPERIORITY||Odds Ratio (OR)|1.119||||0.419|TWO_SIDED|90.0|0.45|2.7846|||odds ratio|Odds ratio and p-value are from a proportional odds model with covariates for treatment group and the randomization stratification factor||||2.7846|0.4500|0.419
70884763|NCT05409235|141254882|SUPERIORITY||difference in percentage of participants|-1.544||||0.6716|TWO_SIDED|90.0|-7.26|4.172|||Mantel Haenszel|||||4.172|-7.260|0.6716
70884764|NCT05409235|141254882|SUPERIORITY||difference in percentage of participants|-3.412||||0.8414|TWO_SIDED|90.0|-9.025|2.2|||Mantel Haenszel|||||2.200|-9.025|0.8414
70884765|NCT05409235|141254883|SUPERIORITY||Mean Difference (Net)|-0.5325||||0.647|TWO_SIDED|90.0|-2.8478|1.7827|||ANCOVA|||||1.7827|-2.8478|0.647
70884766|NCT05409235|141254883|SUPERIORITY||Mean Difference (Net)|-2.2849||||0.945|TWO_SIDED|90.0|-4.6356|0.0658|||ANCOVA|||||0.0658|-4.6356|0.945
70884767|NCT05409235|141254884|SUPERIORITY||Odds Ratio (OR)|1.108||||0.367|TWO_SIDED|90.0|0.6722|1.8276|||odds ratio|Odds ratio and p-value are from a proportional odds model with covariates for treatment group and the randomization stratification factor||||1.8276|0.6722|0.367
70884768|NCT05409235|141254884|SUPERIORITY||Odds Ratio (OR)|0.717||||0.857|TWO_SIDED|90.0|0.4295|1.1981|||odds ratio|Odds ratio and p-value are from a proportional odds model with covariates for treatment group and the randomization stratification factor||||1.1981|0.4295|0.857
70884769|NCT05409235|141254885|SUPERIORITY||Mean Difference (Net)|4.1531||||0.437|TWO_SIDED|90.0|-38.793|47.0991|||ANCOVA|||||47.0991|-38.7930|0.437
70884770|NCT05409235|141254885|SUPERIORITY||Mean Difference (Net)|-16.2461||||0.733|TWO_SIDED|90.0|-59.2538|26.7616|||ANCOVA|||||26.7616|-59.2538|0.733
70884771|NCT05409235|141254886|SUPERIORITY||Mean Difference (Net)|4.0634||||0.77|TWO_SIDED|90.0|-4.9712|13.098|||ANCOVA|||||13.0980|-4.9712|0.770
70884772|NCT05409235|141254886|SUPERIORITY||Mean Difference (Net)|-1.0507||||0.424|TWO_SIDED|90.0|-10.1046|8.0032|||ANCOVA|||||8.0032|-10.1046|0.424
70884773|NCT05409235|141254887|SUPERIORITY||Mean Difference (Net)|0.0205||||0.606|TWO_SIDED|90.0|-0.1043|0.1452|||ANCOVA|||||0.1452|-0.1043|0.606
70884774|NCT05409235|141254887|SUPERIORITY||Mean Difference (Net)|0.0083||||0.544|TWO_SIDED|90.0|-0.1161|0.1326|||ANCOVA|||||0.1326|-0.1161|0.544
70884775|NCT05409235|141254888|SUPERIORITY||difference in percentage of participants|-1.544||||0.406|TWO_SIDED|90.0|-12.247|9.158|||Mantel Haenszel|||||9.158|-12.247|0.406
70884776|NCT05409235|141254888|SUPERIORITY||difference in percentage of participants|1.763||||0.605|TWO_SIDED|90.0|-9.114|12.64|||Mantel Haenszel|||||12.640|-9.114|0.605
70884777|NCT05409235|141254889|SUPERIORITY||Hazard Ratio (HR)|0.916||||0.404|TWO_SIDED|90.0|0.5068|1.6556|||Log Rank|||||1.6556|0.5068|0.404
70884778|NCT05409235|141254889|SUPERIORITY||Hazard Ratio (HR)|1.128||||0.624|TWO_SIDED|90.0|0.6399|1.9868|||Log Rank|||||1.9868|0.6399|0.624
70884779|NCT05409235|141254890|SUPERIORITY||Hazard Ratio (HR)|0.947||||0.478|TWO_SIDED|90.0|0.2473|3.6295|||Log Rank|Comparisons are made using the log-rank test stratified by randomization stratification factor.||||3.6295|0.2473|0.478
70884780|NCT05409235|141254890|SUPERIORITY||Hazard Ratio (HR)|1.296||||0.631|TWO_SIDED|90.0|0.3688|4.5512|||Log Rank|Comparisons are made using the log-rank test stratified by randomization stratification factor||||4.5512|0.3688|0.631
70884781|NCT05409235|141254891|SUPERIORITY||difference in percentage of participants|-13.7727||||0.045|TWO_SIDED|90.0|-27.1319|-0.4134|||Mantel Haenszel|||||-0.4134|-27.1319|0.0450
70884782|NCT05409235|141254891|SUPERIORITY||difference in percentage of participants|-3.8234||||0.3304|TWO_SIDED|90.0|-18.1549|10.5081|||Mantel Haenszel|||||10.5081|-18.1549|0.3304
70884783|NCT05409235|141254892|SUPERIORITY||difference in percentage of participants|-14.8877||||0.0275|TWO_SIDED|90.0|-27.6462|-2.1293|||Mantel Haenszel|||||-2.1293|-27.6462|0.0275
70884784|NCT05409235|141254892|SUPERIORITY||difference in percentage of participants|-7.5535||||0.179|TWO_SIDED|90.0|-21.0688|5.9617|||Mantel Haenszel|||||5.9617|-21.0688|0.1790
70884785|NCT00749931|141254898|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
70884786|NCT00749931|141254899|SUPERIORITY_OR_OTHER||Relative reduction|0.47||||0.002|||||||Fisher Exact|||||||0.002
70884787|NCT00249470|141254920|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.8||||0.004|TWO_SIDED|95.0|2.03|16.56|||General Estimating Equation (GEE)|||||16.56|2.03|.004
70884788|NCT00249470|141254921|SUPERIORITY||Odds Ratio (OR)|0.91|||=|0.82|TWO_SIDED|95.0|0.4|2.08|||General Estimating Equation (GEE)|||||2.08|0.40|=0.82
70884789|NCT00249470|141254922|SUPERIORITY||Odds Ratio (OR)|3.37||||0.04|TWO_SIDED|95.0|1.21|9.37|||General Estimating Equation (GEE)|||||9.37|1.21|0.04
70884790|NCT00500370|141254928|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||<0.0001
70884791|NCT00500370|141254929|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||<0.0001
70884792|NCT00500370|141254930|SUPERIORITY_OR_OTHER|||||||0.6766||95.0|||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.6766
70884793|NCT00500370|141254931|SUPERIORITY_OR_OTHER|||||||0.0393||95.0|||||Cochran-Mantel-Haenszel|||||||0.0393
70884794|NCT00500370|141254932|SUPERIORITY_OR_OTHER|||||||0.1808||95.0|||||ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.1808
70884795|NCT00500370|141254933|SUPERIORITY_OR_OTHER|||||||0.1204||95.0|||||ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.1204
70884796|NCT00500370|141254934|SUPERIORITY_OR_OTHER|||||||0.6651||95.0|||||ANCOVA|||||||0.6651
70884797|NCT00500370|141254935|SUPERIORITY_OR_OTHER|||||||0.1204||95.0|||||ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.1204
70884798|NCT00500370|141254936|SUPERIORITY_OR_OTHER|||||||0.8479||95.0|||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.8479
70884799|NCT00500370|141254937|SUPERIORITY_OR_OTHER|||||||0.2151||95.0|||||ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.2151
70884800|NCT00500370|141254938|SUPERIORITY_OR_OTHER|||||||0.7619||95.0|||||ANCOVA|||||||0.7619
70884801|NCT00500370|141254939|SUPERIORITY_OR_OTHER|||||||0.8973||95.0|||||ANCOVA|||||||0.8973
70884802|NCT00500370|141254940|SUPERIORITY_OR_OTHER|||||||0.6507||95.0|||||Cochran-Mantel-Haenszel|||||||0.6507
70884803|NCT00500370|141254941|SUPERIORITY_OR_OTHER|||||||0.2593||95.0|||||Cochran-Mantel-Haenszel|||||||0.2593
70884804|NCT00500370|141254942|SUPERIORITY_OR_OTHER|||||||0.2919||95.0|||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.2919
70884805|NCT00500370|141254943|SUPERIORITY_OR_OTHER|||||||0.0293||95.0|||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.0293
70884806|NCT01282424|141254944|SUPERIORITY||||||<|0.0001||||||The null hypothesis is ≤ 20%.|Exact binomial test|||||||< 0.0001
70884807|NCT05627518|141254979|OTHER||Ratio|1.9954|||<|0.0001|TWO_SIDED|95.0|1.8399|2.1641|||Mixed Models Analysis||Treatment B (1x100 mg test formulation) divided by treatment A (4x25 mg reference formulation)|The Ratio of geometric mean AUCinf comparing test formulation fasted (treatment B) vs. reference formulation fasted ( treatment A). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||2.1641|1.8399|<0.0001
70884808|NCT05627518|141254979|OTHER||Ratio|2.125|||<|0.0001|TWO_SIDED|95.0|1.9664|2.2963|||Mixed Models Analysis||Treatment B (1x100 mg test formulation) divided by treatment A (4x25 mg reference formulation)|AUClast: Ratio of geometric mean AUClast comparing test formulation fasted (treatment B) vs. reference formulation fasted (treatment A). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||2.2963|1.9664|<0.0001
70884809|NCT05627518|141254980|OTHER|Ratio|Ratio|2.3167|||<|0.0001|TWO_SIDED|95.0|2.0922|2.5652|||Mixed Models Analysis||Treatment B (1x100 mg test formulation) divided by treatment A (4x25 mg reference formulation)|Ratio of geometric mean Cmax comparing test formulation fasted (treatment B) vs. reference formulation fasted (treatment A). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||2.5652|2.0922|<0.0001
70884810|NCT05627518|141254981|OTHER|Ratio|Ratio|0.757|||<|0.0001|TWO_SIDED|95.0|0.7009|0.8177|||Mixed Models Analysis||Treatment C (1x100 mg test formulation fed) divided by treament B (100 mg test formulation fasted)|Ratio of geometric mean AUCinf comparing treatment C (fed) versus treatment B (fasted). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||0.8177|0.7009|<0.0001
70884811|NCT05627518|141254981|OTHER|Ratio|Ratio|0.7684|||<|0.0001|TWO_SIDED|95.0|0.7102|0.8313|||Mixed Models Analysis||Treatment C (1x100 mg test formulation fed) divided by treament B (100 mg test formulation fasted)|Ratio of geometric mean AUClast comparing treatment C (fed) versus treatment B (fasted). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||0.8313|0.7102|<0.0001
70884812|NCT05627518|141254982|OTHER|Ratio|Ratio|0.2548|||<|0.0001|TWO_SIDED|95.0|0.1999|0.3247|||Mixed Models Analysis||Treatment C (1x100 mg test formulation fed) divided by treament B (100 mg test formulation fasted)|Ratio of geometric mean Cmax comparing treatment C (fed) versus treatment B (fasted). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||0.3247|0.1999|<0.0001
70884813|NCT05627518|141254983|OTHER|Ratio|Ratio|3.0245|||<|0.0001|TWO_SIDED|95.0|2.5098|3.6446|||Mixed Models Analysis||Treatment B (1x100 mg test formulation) divided by treament A (4x25 mg reference formulation)|Ratio of geometric mean AUCinf comparing test formulation fasted (treatment B) vs. reference formulation fasted ( treatment A). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||3.6446|2.5098|<0.0001
70884814|NCT05627518|141254983|OTHER|Ratio|Ratio|3.5277|||<|0.0001|TWO_SIDED|95.0|2.9076|4.2799|||Mixed Models Analysis||Treatment B (1x100 mg test formulation) divided by treament A (4x25 mg reference formulation)|Ratio of geometric mean AUClast comparing test formulation fasted (treatment B) vs. reference formulation fasted (treatment A). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||4.2799|2.9076|<0.0001
70884815|NCT05627518|141254984|OTHER|Ratio|Ratio|3.0245|||<|0.0001|TWO_SIDED|95.0|2.5098|3.6446|||Mixed Models Analysis||Treatment B (1x100 mg test formulation) divided by treament A (4x25 mg reference formulation)|Ratio of geometric mean Cmax comparing test formulation fasted (treatment B) vs. reference formulation fasted ( treatment A). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||3.6446|2.5098|<0.0001
70884816|NCT05627518|141254985|OTHER|Ratio|Ratio|0.4923|||<|0.0001|TWO_SIDED|95.0|0.4131|0.5867|||Mixed Models Analysis||Treatment C (1x100 mg test formulation fed) divided by treament B (100 mg test formulation fasted)|Ratio of geometric mean AUCinf comparing treatment C (fed) versus treatment B (fasted). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||0.5867|0.4131|<0.0001
70884817|NCT05627518|141254985|OTHER|Ratio|Ratio|0.4923|||<|0.0001|TWO_SIDED|95.0|0.4047|0.5989|||Mixed Models Analysis||Treatment C (1x100 mg test formulation fed) divided by treament B (100 mg test formulation fasted)|Ratio of geometric mean AUClast comparing treatment C (fed) versus treatment B (fasted). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||0.5989|0.4047|<0.0001
70884818|NCT05627518|141254986|OTHER|Ratio|Ratio|0.2522|||<|0.0001|TWO_SIDED|95.0|0.198|0.3211|||Mixed Models Analysis||Treatment C (1x100 mg test formulation fed) divided by treament B (100 mg test formulation fasted)|Ratio of geometric mean Cmax comparing test formulation fed (treatment C) vs. reference formulation fasted (treatment B). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||0.3211|0.1980|<0.0001
70884819|NCT04976530|141254987|SUPERIORITY||win ratio|1.07||||0.748|TWO_SIDED|95.0|0.72|1.58|||Finkelstein Schoenfeld test|||||1.58|0.72|0.748
70884820|NCT04976530|141254988|SUPERIORITY||win ratio|1.33||||0.202|TWO_SIDED|95.0|0.86|2.04|||Finkelstein Schoenfeld test|||||2.04|0.86|0.202
70884821|NCT04976530|141254989|SUPERIORITY||win ratio|1.17||||0.451|TWO_SIDED|95.0|0.79|1.73|||Finkelstein Schoenfeld test|||||1.73|0.79|0.451
70884822|NCT04976530|141254990|SUPERIORITY||win ratio|1.59||||0.041|TWO_SIDED|95.0|1.02|2.46|||Finkelstein Schoenfeld test|||||2.46|1.02|0.041
70884823|NCT04976530|141254991|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.6
70884824|NCT04976530|141254992|SUPERIORITY|||||||0.079|||||||Wilcoxon (Mann-Whitney)|||||||0.079
70884825|NCT04976530|141254993|SUPERIORITY|||||||0.427|||||||Wilcoxon (Mann-Whitney)|||||||0.427
70884826|NCT04976530|141254994|SUPERIORITY|||||||0.042|||||||Wilcoxon (Mann-Whitney)|||||||0.042
70884827|NCT03750903|141254999|OTHER|||||||0.05|||||||ANOVA|||||||0.05
70884828|NCT00071812|141255027|SUPERIORITY_OR_OTHER||percent difference from placebo|18.8||||0.0097|TWO_SIDED|95.0|4.8|32.8||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||32.8|4.8|0.0097
70884829|NCT00071812|141255027|SUPERIORITY_OR_OTHER||percent difference from placebo|9.4||||0.1677|TWO_SIDED|95.0|-3.9|22.7||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||22.7|-3.9|0.1677
70884830|NCT00071812|141255027|SUPERIORITY_OR_OTHER||percent difference from placebo|12.2||||0.0796|TWO_SIDED|95.0|-1.3|25.8||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||25.8|-1.3|0.0796
70884831|NCT00071812|141255028|SUPERIORITY_OR_OTHER||percent difference from placebo|5.4||||0.2074|TWO_SIDED|95.0|-3.0|13.7||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||13.7|-3.0|0.2074
70884832|NCT00071812|141255028|SUPERIORITY_OR_OTHER||percent difference from placebo|4.1||||0.3177|TWO_SIDED|95.0|-4.0|12.2||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||12.2|-4.0|0.3177
70884833|NCT00071812|141255028|SUPERIORITY_OR_OTHER||percent difference from placebo|9.7||||0.0418|TWO_SIDED|95.0|0.3|19.2||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||19.2|0.3|0.0418
70884834|NCT00071812|141255029|SUPERIORITY_OR_OTHER||percent difference from placebo|2.7||||0.4299|TWO_SIDED|95.0|-4.0|9.3||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||9.3|-4.0|0.4299
70884835|NCT00071812|141255029|SUPERIORITY_OR_OTHER||percent difference from placebo|-1.5||||0.5393|TWO_SIDED|95.0|-6.3|3.3||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||3.3|-6.3|0.5393
70884836|NCT00071812|141255029|SUPERIORITY_OR_OTHER||percent difference from placebo|-0.1||||0.9769|TWO_SIDED|95.0|-5.6|5.4||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||5.4|-5.6|0.9769
70884837|NCT00071812|141255030|SUPERIORITY_OR_OTHER|||||||0.1752||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have any ACR response were censored at the last visit or exit visit, whichever occurred first. Patients who did not have an ACR response and discontinued from the study prior to study completion were censored at the last date on study.||||0.1752
70884838|NCT00071812|141255030|SUPERIORITY_OR_OTHER|||||||0.344||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have any ACR response were censored at the last visit or exit visit, whichever occurred first. Patients who did not have an ACR response and discontinued from the study prior to study completion were censored at the last date on study.||||0.3440
70884839|NCT00071812|141255030|SUPERIORITY_OR_OTHER|||||||0.4308||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have any ACR response were censored at the last visit or exit visit, whichever occurred first. Patients who did not have an ACR response and discontinued from the study prior to study completion were censored at the last date on study.||||0.4308
70884840|NCT00071812|141255033|SUPERIORITY_OR_OTHER|||||||0.0958||95.0||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using last observation carried forward (LOCF) imputation.||||0.0958
70884841|NCT00071812|141255033|SUPERIORITY_OR_OTHER|||||||0.7864||95.0||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||||0.7864
70884842|NCT00071812|141255033|SUPERIORITY_OR_OTHER|||||||0.0051||95.0||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||||0.0051
70963549|NCT00578786|141431980|SUPERIORITY_OR_OTHER||Median Difference (Net)|29.5|STANDARD_DEVIATION|89.81|||TWO_SIDED|95.0|20.4|38.7|||||Applies to Ambrisentan combined group only. LOCF method of imputation.|||38.7|20.4|
70884843|NCT00071812|141255034|SUPERIORITY_OR_OTHER|||||||0.096||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have good or moderate improvement in DAS28 were censored at the last visit or exit visit, whichever occurred first. Patients who did not have good or moderate improvement in DAS28 and discontinued from the study prior to study completion were censored at the last date on study.||||0.0960
70884844|NCT00071812|141255034|SUPERIORITY_OR_OTHER|||||||0.2859||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have good or moderate improvement in DAS28 were censored at the last visit or exit visit, whichever occurred first. Patients who did not have good or moderate improvement in DAS28 and discontinued from the study prior to study completion were censored at the last date on study.||||0.2859
70884845|NCT00071812|141255034|SUPERIORITY_OR_OTHER|||||||0.0109||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have good or moderate improvement in DAS28 were censored at the last visit or exit visit, whichever occurred first. Patients who did not have good or moderate improvement in DAS28 and discontinued from the study prior to study completion were censored at the last date on study.||||0.0109
70884846|NCT00071812|141255035|SUPERIORITY_OR_OTHER|||||||0.194||95.0||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||||0.1940
70884847|NCT00071812|141255035|SUPERIORITY_OR_OTHER|||||||0.2561||95.0||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||||0.2561
70884848|NCT00071812|141255035|SUPERIORITY_OR_OTHER|||||||0.8707||95.0||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||||0.8707
70884849|NCT00640510|141255093|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||t-test, 2 sided|||A sample size of at least 15 patients per group was necessary to verify that the decrease in PANSS-EC total score was significantly greater in the IM olanzapine group than the placebo group using Student's t-test with a power of 90% at a two-sided significance level of 5%.||||0.940
70884850|NCT00640510|141255094|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for Change from Baseline to 15 minutes. Change = Timepoint minus Baseline.|t-test, 2 sided|||||||1.000
70884851|NCT00640510|141255094|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||P-value for Change from Baseline to 30 minutes. Change = Timepoint minus baseline.|t-test, 2 sided|||||||0.620
70884852|NCT00640510|141255094|SUPERIORITY_OR_OTHER|||||||0.784||95.0||||P-value for Change from Baseline to 60 minutes. Change = Timepoint minus baseline.|t-test, 2 sided|||||||0.784
70884853|NCT00640510|141255094|SUPERIORITY_OR_OTHER|||||||0.756||95.0||||P-value for Change from Baseline to 90 minutes. Change = Timepoint minus baseline.|t-test, 2 sided|||||||0.756
70884854|NCT00640510|141255095|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.000
70884855|NCT00640510|141255096|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for 30 Minutes.|Fisher Exact|||||||1.000
70884856|NCT00640510|141255096|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for 60 Minutes.|Fisher Exact|||||||1.000
70963550|NCT00578786|141431981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.7|STANDARD_DEVIATION|97.48|||TWO_SIDED|95.0|-13.4|26.8|||||Applies to Ambrisentan 2.5 mg group only. LOCF method of imputation.|||26.8|-13.4|
70884857|NCT00640510|141255096|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for 90 Minutes.|Fisher Exact|||||||1.000
70884858|NCT00640510|141255096|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for 2 Hours.|Fisher Exact|||||||1.000
70884859|NCT01096784|141255116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0642||95.0|||||CMH Row Mean Score Test|||||||0.0642
70884860|NCT03761628|141255130|OTHER|The clinical performance endpoint - Clinical cure rate on Day 7 - was calculated and presented together with a one-sided 95% CI based on the exact binomial distribution (Clopper-Pearson).|Clinical cure rate|40.9|||||ONE_SIDED|95.0|23.3|||||||"It was assumed that the true cure rate was equal to 70%, therefore 22 patients were needed to obtain 90% chance (90% power) to show that the one-sided 95% CI for the observed cure rate was above 40%.~Hypotheses for the primary clinical performance endpoint:~* Null hypothesis: Clinical cure rate is less than or equal to 40%.~* Alternative hypothesis (one-sided): Clinical cure rate is above 40%."|||23.3|
70884861|NCT03761628|141255131|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Proportion with reduction|72.7|||||TWO_SIDED|95.0|49.8|89.3||||||||89.3|49.8|
70884862|NCT03761628|141255133|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Recurrence rate Day 14|12.5|||||TWO_SIDED|95.0|0.3|52.7||||||||52.7|0.3|
70884863|NCT03761628|141255133|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Recurrence rate Day 35|0.0|||||TWO_SIDED|95.0|0.0|45.9||||||||45.9|0|
70884864|NCT03064126|141255134|SUPERIORITY||Risk Difference (RD)|0.166||||0.0017|ONE_SIDED|97.5|0.0553||||Chi-squared||||||0.0553|0.0017
70884865|NCT03064126|141255135|NON_INFERIORITY|A Chi-Square Test was used to assess the hypothesis for the difference in 12-month MAE-free rate with non-inferiority margin (-10%).|Risk Difference (RD)|0.106|||<|0.0001|ONE_SIDED|97.5|0.0248||||Chi-squared||||||0.0248|<0.0001
70884866|NCT03907683|141255169|SUPERIORITY||Mean Difference (Final Values)|0.16412|STANDARD_ERROR_OF_MEAN|0.08||0.037|TWO_SIDED|95.0|0.0098|0.3185|||t-test, 2 sided|||Null hypothesis was that the mean steady state response to weekday move more messages would not differ from zero||0.3185|.0098|0.037
70884867|NCT03907683|141255169|SUPERIORITY||Mean Difference (Net)|0.12538|STANDARD_ERROR_OF_MEAN|0.07674||0.106|TWO_SIDED|95.0|-0.0274|0.2781|||t-test, 2 sided|||Null hypothesis was that the mean steady state response to weekday sit less messages would not differ from zero||0.2781|-0.0274|.106
70884868|NCT03907683|141255169|SUPERIORITY||Mean Difference (Net)|0.24738|STANDARD_ERROR_OF_MEAN|0.13746||0.076|TWO_SIDED|95.0|-0.0262|0.521|||t-test, 2 sided|||Null hypothesis was that the mean steady state response to weekday inspirational quote messages would not differ from zero||.5210|-.0262|.076
70884869|NCT03907683|141255169|SUPERIORITY||Mean Difference (Net)|0.30563|STANDARD_ERROR_OF_MEAN|0.16136||0.062|TWO_SIDED|95.0|-0.0156|0.6268|||t-test, 2 sided|||Null hypothesis was that the mean steady state response to weekend move more messages would not differ from zero||.6268|-.0156|.062
70963551|NCT00578786|141431981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|23.2|STANDARD_DEVIATION|100.69|||TWO_SIDED|95.0|8.7|37.8|||||Applies to Ambrisentan 5 mg group only. LOCF method of imputation.|||37.8|8.7|
70884870|NCT03907683|141255169|SUPERIORITY||Mean Difference (Net)|0.277|STANDARD_ERROR_OF_MEAN|0.10676||0.11|TWO_SIDED|95.0|0.0645|0.4895|||t-test, 2 sided|||Null hypothesis was that the mean steady state response to weekend sit less messages would not differ from zero||.4895|.0645|0.11
70884871|NCT03907683|141255169|SUPERIORITY||Mean Difference (Net)|0.10837|STANDARD_ERROR_OF_MEAN|0.16895||0.523|TWO_SIDED|95.0|-0.2279|0.4447|||t-test, 2 sided|||Null hypothesis was that the mean steady state response to weekend inspirational quote messages would not differ from zero||0.4447|-0.2279|.523
70884872|NCT02975934|141255170|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.36|0.69|||Log Rank|||||0.69|0.36|<0.001
70884873|NCT02975934|141255171|SUPERIORITY||Hazard Ratio (HR)|0.61|||<|0.001|TWO_SIDED|95.0|0.47|0.8|||Log Rank|||||0.80|0.47|<0.001
70884874|NCT02975934|141255172|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.5044|TWO_SIDED|95.0|0.68|1.2|||Log Rank|||||1.20|0.68|0.5044
70884875|NCT02975934|141255173|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9368|TWO_SIDED|95.0|0.78|1.26|||Log Rank|||||1.26|0.78|0.9368
70884876|NCT02075840|141255188|SUPERIORITY||Hazard Ratio, stratified|0.47|||<|0.0001|TWO_SIDED|95.0|0.34|0.65|||Log Rank|||Stratified hazard ratio and p-value are stratified for covariates Race (Asian vs Non-Asian) and CNS metastases at baseline by IRC.||0.65|0.34|<0.0001
70884877|NCT02075840|141255190|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.36|0.7|||Log Rank|Stratified hazard ratio and p-value are stratified for covariates Race (Asian vs Non-Asian) and CNS metastases at baseline by IRC.||||0.70|0.36|<0.0001
70884878|NCT02075840|141255192|SUPERIORITY|IRC, RECIST v1.1 Stratified Analysis (by race (Asian vs non-Asian) and CNS metastases at baseline by IRC)|Cause-Specific Hazard Ratio|0.16|||<|0.0001|TWO_SIDED|95.0|0.1|0.28|||Log Rank|||||0.28|0.10|<0.0001
70884879|NCT02075840|141255194|SUPERIORITY||Difference in Overall Response Rates|7.4||||0.0936|TWO_SIDED|95.0|-1.71|16.5||Stratified analysis|Mantel Haenszel|||||16.50|-1.71|0.0936
70884880|NCT02075840|141255196|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.2405|TWO_SIDED|95.0|0.48|1.2||Stratified analysis|Log Rank|||||1.20|0.48|0.2405
70884881|NCT02075840|141255207|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.2079|TWO_SIDED|95.0|0.46|1.19|||Log Rank|Stratified analysis||Fatigue||1.19|0.46|0.2079
70884882|NCT02075840|141255207|SUPERIORITY||Hazard Ratio (HR)|1.66||||0.1137|TWO_SIDED|95.0|0.88|3.15||Stratified analysis|Log Rank|||Dyspnea||3.15|0.88|0.1137
70884883|NCT02075840|141255209|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.7042|TWO_SIDED|95.0|0.44|1.74||Stratified analysis|Log Rank|||Coughing||1.74|0.44|0.7042
70884884|NCT02075840|141255209|SUPERIORITY||Hazard Ratio (HR)|1.76||||0.0285|TWO_SIDED|95.0|1.05|2.92||Stratified analysis|Log Rank|||Dyspnea||2.92|1.05|0.0285
70884885|NCT02075840|141255209|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.2377|TWO_SIDED|95.0|0.79|2.61||Stratified analysis|Log Rank|||Pain in arm and shoulder||2.61|0.79|0.2377
70884886|NCT02075840|141255209|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.0796|TWO_SIDED|95.0|0.24|1.1||Stratified analysis|Log Rank|||Pain in chest||1.10|0.24|0.0796
70884887|NCT02075840|141255209|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.6435|TWO_SIDED|95.0|0.72|1.68||Stratified analysis|Log Rank|||Composite score||1.68|0.72|0.6435
70884888|NCT00846742|141255216|SUPERIORITY|||||||0.0003||||||Comparison of proportion of patients' complete response rate between HOD99 (NCT number: NCT00145600) and HOD08|Exact Binominal Test|||The proportion of patients' complete response rate was provided with a 95% confidence interval.||||0.0003
70884889|NCT00846742|141255221|SUPERIORITY||Hazard Ratio (HR)|0.969||||0.732|TWO_SIDED|95.0|0.81|1.159|||Fine-Gray model||The sub-distribution hazard ratio for the 2-year cumulative incidence of local failure with a 1-year increase in age.|||1.159|0.810|0.732
70884890|NCT00846742|141255222|SUPERIORITY||Hazard Ratio (HR)|0.0|||<|0.001|TWO_SIDED|95.0|0.0|0.0|||Fine-Gray model||The sub-distribution hazard ratio for the 2-year cumulative incidence of local failure comparing males to females.|Male vs. Female, with Female as the reference level||0.000|0.000|<0.001
70884891|NCT00846742|141255223|SUPERIORITY||Hazard Ratio (HR)|30101.41|||<|0.001|TWO_SIDED|95.0|3329.573|272135.5|||Fine-Gray model||The sub-distribution hazard ratio for the 2-year cumulative incidence of local failure comparing Stage IIA to Stage IA.|Stage IIA vs. Stage IA, with Stage IA as the reference level||272135.500|3329.573|<0.001
70884892|NCT00846742|141255224|SUPERIORITY||Hazard Ratio (HR)|34027.68|||<|0.001|TWO_SIDED|95.0|4072.872|284291.6|||Fine-Gray model||The sub-distribution hazard ratio for the 2-year cumulative incidence of local failure comparing Classical (all combined) to Nodular Lymphocyte Predominant Hodgkin Lymphoma.|Classical (all combined) vs. Nodular lymphocyte predominant, with Nodular lymphocyte predominant as the reference level||284291.600|4072.872|<0.001
70884893|NCT00846742|141255225|SUPERIORITY|||||||0.461|||||||Log Rank|||Comparing the 2-year EFS between HOD08 Participants and HOD99 Participants||||0.461
70884894|NCT00846742|141255225|SUPERIORITY|||||||1|||||||Log Rank|||Comparing the 2-year OS between HOD08 Participants and HOD99 Participants||||1.000
70884895|NCT00846742|141255225|SUPERIORITY|||||||0.836|||||||Gray's test|||Comparing the 2-year CI of Local Failure between HOD08 Participants and HOD99 Participants||||0.836
70884896|NCT00846742|141255227|SUPERIORITY|||||||0.384|||||||Log Rank|||Comparing the 2-year EFS between HOD08 - CR and HOD99 - CR||||0.384
70884897|NCT00846742|141255227|SUPERIORITY|||||||1|||||||Log Rank|||Comparing the 2-year OS between HOD08 - CR and HOD99 - CR||||1.000
70884898|NCT00846742|141255227|SUPERIORITY|||||||0.386|||||||Gray's test|||Comparing the 2-year CI of Local Failure between HOD08 - CR and HOD99 - CR||||0.386
70884899|NCT00846742|141255228|SUPERIORITY|||||||0.986|||||||Log Rank|||Comparing the 2-year EFS of patients treated without and with RT||||0.986
70884900|NCT02775344|141255229|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.198|TWO_SIDED||||||Chi-squared, Corrected|||||||0.198
70884901|NCT02775344|141255230|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.393|TWO_SIDED||||||Chi-squared, Corrected|||||||0.393
70884902|NCT03909165|141255243|OTHER||Geometric Mean Ratio (GMR)|0.83|||||TWO_SIDED|90.0|0.56|1.21||||||2 mg/kg AUC0-inf Geometric Mean Ratio (GMR) = Birth to 27 days AUC0-inf Geometric Mean (GM) / 28 days to \< 3 months AUC0-inf GM.||1.21|0.56|
70884903|NCT03909165|141255243|OTHER||Geometric Mean Ratio (GMR)|1.41|||||TWO_SIDED|90.0|1.0|1.98||||||2 mg/kg AUC0-inf GMR = 28 days to \< 3 months AUC0-inf GM / 3 to \< 6 months AUC0-inf GM.||1.98|1.00|
70884904|NCT03909165|141255243|OTHER||Geometric Mean Ratio (GMR)|0.82|||||TWO_SIDED|90.0|0.6|1.11||||||2 mg/kg AUC0-inf GMR = 3 to \< 6 months AUC0-inf GM / 6 months to \< 2 years AUC0-inf GM.||1.11|0.60|
70884905|NCT03909165|141255243|OTHER||Geometric Mean Ratio (GMR)|1.23|||||TWO_SIDED|90.0|0.96|1.56||||||4 mg/kg AUC0-inf GMR = Birth to 27 days AUC0-inf GM / 28 days to \< 3 months AUC0-inf GM.||1.56|0.96|
70884906|NCT03909165|141255243|OTHER||Geometric Mean Ratio (GMR)|1.29|||||TWO_SIDED|90.0|1.03|1.62||||||4 mg/kg AUC0-inf GMR = 28 days to \< 3 months AUC0-inf GM / 3 to \< 6 months AUC0-inf GM.||1.62|1.03|
70884907|NCT03909165|141255243|OTHER||Geometric Mean Ratio (GMR)|0.89|||||TWO_SIDED|90.0|0.7|1.13||||||4 mg/kg AUC0-inf GMR = 3 to \< 6 months AUC0-inf GM / 6 months to \< 2 years AUC0-inf GM.||1.13|0.70|
70884908|NCT03909165|141255244|OTHER||Geometric Mean Ratio (GMR)|0.91|||||TWO_SIDED|90.0|0.67|1.23||||||2 mg/kg AUC0-1hr GMR = Birth to 27 days AUC0-1hr GM / 28 days to \< 3 months AUC0-1hr GM.||1.23|0.67|
70884909|NCT03909165|141255244|OTHER||Geometric Mean Ratio (GMR)|1.25|||||TWO_SIDED|90.0|0.92|1.69||||||2 mg/kg AUC0-1hr GMR = 28 days to \< 3 months AUC0-1hr GM / 3 to \< 6 months AUC0-1hr GM.||1.69|0.92|
70884910|NCT03909165|141255244|OTHER||Geometric Mean Ratio (GMR)|0.83|||||TWO_SIDED|90.0|0.64|1.08||||||2 mg/kg AUC0-1hr GMR = 3 to \< 6 months AUC0-1hr GM / 6 months to \< 2 years AUC0-1hr GM.||1.08|0.64|
70884911|NCT03909165|141255244|OTHER||Geometric Mean Ratio (GMR)|0.86|||||TWO_SIDED|90.0|0.7|1.06||||||4 mg/kg AUC0-1hr GMR = Birth to 27 days AUC0-1hr GM / 28 days to \< 3 months AUC0-1hr GM.||1.06|0.70|
70884912|NCT03909165|141255244|OTHER||Geometric Mean Ratio (GMR)|1.07|||||TWO_SIDED|90.0|0.89|1.29||||||4 mg/kg AUC0-1hr GMR = 28 days to \< 3 months AUC0-1hr GM / 3 to \< 6 months AUC0-1hr GM.||1.29|0.89|
70884913|NCT03909165|141255244|OTHER||Geometric Mean Ratio (GMR)|0.97|||||TWO_SIDED|90.0|0.8|1.17||||||4 mg/kg AUC0-1hr GMR = 3 to \< 6 months AUC0-1hr GM / 6 months to \< 2 years AUC0-1hr GM.||1.17|0.80|
70884914|NCT03909165|141255246|OTHER||Geometric Mean Ratio (GMR)|0.92|||||TWO_SIDED|90.0|0.61|1.4||||||2 mg/kg Cmax GMR = Birth to 27 days Cmax GM / 28 days to \< 3 months Cmax GM.||1.40|0.61|
70884915|NCT03909165|141255246|OTHER||Geometric Mean Ratio (GMR)|1.09|||||TWO_SIDED|90.0|0.7|1.7||||||2 mg/kg Cmax GMR = 28 days to \< 3 months Cmax GM / 3 to \< 6 months Cmax GM.||1.70|0.70|
70884916|NCT03909165|141255246|OTHER||Geometric Mean Ratio (GMR)|0.92|||||TWO_SIDED|90.0|0.63|1.36||||||2 mg/kg Cmax GMR = 3 to \< 6 months Cmax GM / 6 months to \< 2 years Cmax GM.||1.36|0.63|
70884917|NCT03909165|141255246|OTHER||Geometric Mean Ratio (GMR)|0.94|||||TWO_SIDED|90.0|0.7|1.26||||||4 mg/kg Cmax GMR = Birth to 27 days Cmax GM / 28 days to \< 3 months Cmax GM.||1.26|0.70|
70884918|NCT03909165|141255246|OTHER||Geometric Mean Ratio (GMR)|0.68|||||TWO_SIDED|90.0|0.52|0.89||||||4 mg/kg Cmax GMR = 28 days to \< 3 months Cmax GM / 3 to \< 6 months Cmax GM.||0.89|0.52|
70884919|NCT03909165|141255246|OTHER||Geometric Mean Ratio (GMR)|1.09|||||TWO_SIDED|90.0|0.83|1.43||||||4 mg/kg AUC0-1hr GMR = 3 to \< 6 months Cmax GM / 6 months to \< 2 years Cmax GM.||1.43|0.83|
70884920|NCT03909165|141255251|SUPERIORITY||Hazard Ratio (HR)|2.4|||=|0.0002|TWO_SIDED|95.0|1.37|4.18||Two-sided p-value based on log-rank test stratified by neuromuscular blocking agent and age groups.|Log Rank|||The Hazard Ratio (HR) for the pairwise comparison of Sugammadex 2 mg/kg vs. Neostigmine + (Glycopyrrolate or Atropine) was based on a Cox regression model with Efron's method of tie handling with covariates of treatment, age (continuous) and stratified by neuromuscular blocking agent.||4.18|1.37|= 0.0002
70884921|NCT03909165|141255252|OTHER||Difference in Percentage|7.6|||||TWO_SIDED|95.0|-14.2|29.5||||||The difference in percentage of participants with an AE in sugammadex 2 mg/kg group versus the Neostigmine + (Glycopyrrolate or Atropine) group was based on the Miettinen and Nurminen method stratified by neuromuscular blocking agent and age group.||29.5|-14.2|
70884922|NCT03909165|141255252|OTHER||Difference in Percentage|5.9|||||TWO_SIDED|95.0|-13.5|26.7||||||The difference in percentage of participants with an AE in sugammadex 4 mg/kg group versus the Neostigmine + (Glycopyrrolate or Atropine) group was based on the Miettinen and Nurminen method stratified by neuromuscular blocking agent and age group.||26.7|-13.5|
70884923|NCT04609020|141255254|SUPERIORITY||Mean Difference (Final Values)|46.6|STANDARD_DEVIATION|23.61|<|0.0001|ONE_SIDED|97.5|40.58|||P-value is calculated based on 1-sided t-test or Wilcoxon signed-rank test (if the normality assumption is not met) at 0.025 significance level.|t-test, 1 sided||||||40.58|<0.0001
70884924|NCT04609020|141255255|SUPERIORITY||Mean Difference (Final Values)|35.3|STANDARD_DEVIATION|22.36|<|0.0001|ONE_SIDED|97.5|29.61|||P-value is calculated based on 1-sided t-test or Wilcoxon signed-rank test (if the normality assumption is not met) at 0.025 significance level.|t-test, 1 sided||||||29.61|<0.0001
70884925|NCT04609020|141255256|SUPERIORITY||Mean Difference (Final Values)|27.6|STANDARD_DEVIATION|23.23|<|0.0001|ONE_SIDED|97.5|21.5|||P-value is calculated based on 1-sided t-test or Wilcoxon signed-rank test (if the normality assumption is not met) at 0.025 significance level.|t-test, 1 sided||||||21.50|<0.0001
70884926|NCT04609020|141255257|SUPERIORITY||Mean Difference (Final Values)|22.9|STANDARD_DEVIATION|20.56|<|0.0001|ONE_SIDED|97.5|17.65|||P-value is calculated based on 1-sided t-test or Wilcoxon signed-rank test (if the normality assumption is not met) at 0.025 significance level.|t-test, 1 sided||||||17.65|<0.0001
70884927|NCT04609020|141255258|SUPERIORITY||Mean Difference (Final Values)|43.1|STANDARD_DEVIATION|22.25|<|0.0001|ONE_SIDED|97.5|37.48|||P-value is calculated based on 1-sided t-test or Wilcoxon signed-rank test (if the normality assumption is not met) at 0.025 significance level.|t-test, 1 sided||||||37.48|<0.0001
70884928|NCT01479621|141255305|SUPERIORITY_OR_OTHER|||||||0.0001||||||The study was considered positive if the trend test was positive and the test involving the highest Fp MDPI dose (100 mcg twice daily) indicated significantly greater time averaged FEV1 mean than placebo.|Regression, Linear|||A linear in log-dose trend contrast evaluated the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo). A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level. Specifically, the 2-sided linear in log-dose time-averaged trend test was first performed followed by pairwise comparisons of each Fp MDPI dose versus placebo.||||0.0001
70884929|NCT01479621|141255305|SUPERIORITY_OR_OTHER||LSM difference|0.149||||0.0005|TWO_SIDED|95.0|0.066|0.233||The study was considered positive if the trend test was positive and the test involving the highest Fp MDPI dose (100 mcg twice daily) indicated significantly greater time averaged FEV1 mean than placebo.|mixed model for repeated measures|||This is the second analysis in the fixed-sequence testing procedure employed to control the overall Type I error rate at the 0.05 level.||0.233|0.066|0.0005
70884930|NCT01479621|141255305|SUPERIORITY_OR_OTHER||LSM difference|0.126||||0.0027|TWO_SIDED|95.0|0.044|0.208|||mixed model for repeated measures|||This is the third analysis in the fixed-sequence testing procedure employed to control the overall Type I error rate at the 0.05 level.||0.208|0.044|0.0027
70884931|NCT01479621|141255305|SUPERIORITY_OR_OTHER||LSM difference|0.111||||0.0086|TWO_SIDED|95.0|0.028|0.194|||mixed model for repeated measures|||This is the fourth analysis in the fixed-sequence testing procedure employed to control the overall Type I error rate at the 0.05 level.||0.194|0.028|0.0086
70884932|NCT01479621|141255305|SUPERIORITY_OR_OTHER||LSM difference|0.052||||0.2227|TWO_SIDED|95.0|-0.032|0.136|||mixed model for repeated measures|||This is the fifth analysis in the fixed-sequence testing procedure employed to control the overall Type I error rate at the 0.05 level.||0.136|-0.032|0.2227
70884933|NCT01479621|141255306|SUPERIORITY_OR_OTHER|||||||0.0017||||||Significance at 0.05|Regression, Linear|||A linear in log-dose trend contrast evaluated the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo).||||0.0017
70884934|NCT01479621|141255306|SUPERIORITY_OR_OTHER||LSM difference|18.29||||0.006|TWO_SIDED|95.0|5.28|31.29||Significance at 0.05|mixed model for repeated measures|||||31.29|5.28|0.0060
70884935|NCT01479621|141255306|SUPERIORITY_OR_OTHER||LSM difference|20.32||||0.0018|TWO_SIDED|95.0|7.61|33.03||Significance at 0.05|mixed model for repeated measures|||||33.03|7.61|0.0018
70884936|NCT01479621|141255306|SUPERIORITY_OR_OTHER||LSM difference|11.75||||0.0741|TWO_SIDED|95.0|-1.15|24.64||Significance at 0.05|mixed model for repeated measures|||||24.64|-1.15|0.0741
70884937|NCT01479621|141255306|SUPERIORITY_OR_OTHER||LSM difference|21.72||||0.0011|TWO_SIDED|95.0|8.73|34.72||Significance at 0.05|mixed model for repeated measures|||||34.72|8.73|0.0011
70884938|NCT01479621|141255307|SUPERIORITY_OR_OTHER|||||||0.0434||||||Significance at 0.05|Regression, Linear|||A linear in log-dose trend contrast evaluated the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo).||||0.0434
70884939|NCT01479621|141255307|SUPERIORITY_OR_OTHER||LSM difference|11.06||||0.0852|TWO_SIDED|95.0|-1.54|23.66||Significance at 0.05|mixed model for repeated measures|||||23.66|-1.54|0.0852
70884940|NCT01479621|141255307|SUPERIORITY_OR_OTHER||LSM difference|12.78||||0.0411|TWO_SIDED|95.0|0.52|25.04||Significance at 0.05|mixed model for repeated measures|||||25.04|0.52|0.0411
70884941|NCT01479621|141255307|SUPERIORITY_OR_OTHER||LSM difference|9.28||||0.1428|TWO_SIDED|95.0|-3.14|21.69||Significance at 0.05|mixed model for repeated measures|||||21.69|-3.14|0.1428
70884942|NCT01479621|141255307|SUPERIORITY_OR_OTHER||LSM difference|18.23||||0.0046|TWO_SIDED|95.0|5.64|30.82||Significance at 0.05|mixed model for repeated measures|||||30.82|5.64|0.0046
70884943|NCT01479621|141255308|SUPERIORITY_OR_OTHER||estimated mean difference from placebo|2.76||||0.66685|TWO_SIDED|95.0|-10.07|15.6|||GEE|The model contained covariates for sex, age, and treatment. The baseline level was estimated for all subjects combined, adjusted for covariates.||The generalized estimating equation (GEE) algorithm was used to fit the model, using a robust estimator for the variance which provided a proper adjustment for possible correlation between the 2 measurements on each subject. This model was used to obtain 2-sided 95% confidence limits for the difference in treatment effects of Fp MDPI versus placebo.||15.60|-10.07|0.66685
70884944|NCT01479621|141255308|SUPERIORITY_OR_OTHER||estimated mean difference from placebo|6.76||||0.26741|TWO_SIDED|95.0|-5.43|18.94||The model contained covariates for sex, age, and treatment. The baseline level was estimated for all subjects combined, adjusted for covariates.|GEE|||The generalized estimating equation (GEE) algorithm was used to fit the model, using a robust estimator for the variance which provided a proper adjustment for possible correlation between the 2 measurements on each subject. This model was used to obtain 2-sided 95% confidence limits for the difference in treatment effects of Fp MDPI versus placebo.||18.94|-5.43|0.26741
70884945|NCT01479621|141255308|SUPERIORITY_OR_OTHER||estimated mean difference from placebo|10.45||||0.09964|TWO_SIDED|95.0|-2.24|23.15||The model contained covariates for sex, age, and treatment. The baseline level was estimated for all subjects combined, adjusted for covariates.|GEE|||The generalized estimating equation (GEE) algorithm was used to fit the model, using a robust estimator for the variance which provided a proper adjustment for possible correlation between the 2 measurements on each subject. This model was used to obtain 2-sided 95% confidence limits for the difference in treatment effects of Fp MDPI versus placebo.||23.15|-2.24|0.09964
70884946|NCT01479621|141255308|SUPERIORITY_OR_OTHER||Slope|12.78||||0.03825|TWO_SIDED|95.0|0.44|25.11||The model contained covariates for sex, age, and treatment. The baseline level was estimated for all subjects combined, adjusted for covariates.|GEE|||The generalized estimating equation (GEE) algorithm was used to fit the model, using a robust estimator for the variance which provided a proper adjustment for possible correlation between the 2 measurements on each subject. This model was used to obtain 2-sided 95% confidence limits for the difference in treatment effects of Fp MDPI versus placebo.||25.11|0.44|0.03825
70884947|NCT01479621|141255309|SUPERIORITY_OR_OTHER|||||||0.2841||||||Significance at 0.05|Log Rank|||Comparison of survival curve to placebo||||0.2841
70884948|NCT01479621|141255309|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Significance at 0.05|Log Rank|||Comparison of survival curve to placebo||||<0.0001
70884949|NCT01479621|141255309|SUPERIORITY_OR_OTHER|||||||0.0008||||||Significance at 0.05|Log Rank|||Comparison of survival curve to placebo||||0.0008
70884950|NCT01479621|141255309|SUPERIORITY_OR_OTHER|||||||0.001||||||Significance at 0.05|Log Rank|||Comparison of survival curve to placebo||||0.0010
70884951|NCT01479621|141255315|SUPERIORITY_OR_OTHER||LSM difference|-0.114||||0.0058|TWO_SIDED|95.0|-0.195|-0.033||Significance at 0.05|mixed model for repeated measures|||||-0.033|-0.195|0.0058
70884952|NCT01479621|141255315|SUPERIORITY_OR_OTHER||LSM difference|0.034||||0.4083|TWO_SIDED|95.0|-0.046|0.114||Significance at 0.05|mixed model for repeated measures|||||0.114|-0.046|0.4083
70884953|NCT01479621|141255315|SUPERIORITY_OR_OTHER||LSM difference|0.011||||0.7882|TWO_SIDED|95.0|-0.068|0.089||Significance at 0.05|mixed model for repeated measures|||||0.089|-0.068|0.7882
70884954|NCT01479621|141255315|SUPERIORITY_OR_OTHER||LSM difference|-0.002||||0.9586|TWO_SIDED|95.0|-0.082|0.078||Significance at 0.05|mixed model for repeated measures|||||0.078|-0.082|0.9586
70884955|NCT01479621|141255315|SUPERIORITY_OR_OTHER||LSM difference|-0.062||||0.1306|TWO_SIDED|95.0|-0.143|0.018||Significance at 0.05|mixed model for repeated measures|||||0.018|-0.143|0.1306
70884956|NCT01479621|141255316|SUPERIORITY_OR_OTHER||LSM difference|-17.66||||0.0068|TWO_SIDED|95.0|-30.43|-4.89||Significance at 0.05|mixed model for repeated measures|||||-4.89|-30.43|0.0068
70884957|NCT01479621|141255316|SUPERIORITY_OR_OTHER||LSM difference|0.69||||0.9135|TWO_SIDED|95.0|-11.84|13.23||Significance at 0.05|mixed model for repeated measures|||||13.23|-11.84|0.9135
70884958|NCT01479621|141255316|SUPERIORITY_OR_OTHER||LSM difference|2.67||||0.6689|TWO_SIDED|95.0|-9.58|14.92||Significance at 0.05|mixed model for repeated measures|||||14.92|-9.58|0.6689
70884959|NCT01479621|141255316|SUPERIORITY_OR_OTHER||LSM difference|-5.69||||0.3691|TWO_SIDED|95.0|-18.12|6.74||Significance at 0.05|mixed model for repeated measures|||||6.74|-18.12|0.3691
70884960|NCT01479621|141255316|SUPERIORITY_OR_OTHER||LSM difference|4.24||||0.5072|TWO_SIDED|95.0|-8.31|16.78||Significance at 0.05|mixed model for repeated measures|||||16.78|-8.31|0.5072
70884961|NCT01479621|141255317|SUPERIORITY_OR_OTHER||LSM difference|-15.26||||0.0158|TWO_SIDED|95.0|-27.63|-2.88||Significance at 0.05|mixed model for repeated measures|||||-2.88|-27.63|0.0158
70884962|NCT01479621|141255317|SUPERIORITY_OR_OTHER||LSM difference|-4.48||||0.4709|TWO_SIDED|95.0|-16.69|7.721||Significance at 0.05|mixed model for repeated measures|||||7.721|-16.69|0.4709
70884963|NCT01479621|141255317|SUPERIORITY_OR_OTHER||LSM difference|-2.68||||0.6572|TWO_SIDED|95.0|-14.55|9.19||Significance at 0.05|mixed model for repeated measures|||||9.19|-14.55|0.6572
70884964|NCT01479621|141255317|SUPERIORITY_OR_OTHER||LSM difference|-5.98||||0.3292|TWO_SIDED|95.0|-18.01|6.05||Significance at 0.05|mixed model for repeated measures|||||6.05|-18.01|0.3292
70884965|NCT01479621|141255317|SUPERIORITY_OR_OTHER||LSM difference|3.05||||0.6237|TWO_SIDED|95.0|-9.16|15.26||Significance at 0.05|mixed model for repeated measures|||||15.26|-9.16|0.6237
70884966|NCT01434290|141255456|SUPERIORITY|||||||0.19|||||||One sample z-test|One-sided 0.025 significance level||≤35% was considered acceptable, ≥55% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used. For a given arm, if the null hypothesis of p ≤ 0.35 is rejected, then conclude that the regimen given on that arm is unacceptable. However if it not rejected for both bowel \& urinary domains, then that regimen will be considered acceptable for further use in a Phase III study.||||0.19
70884967|NCT01434290|141255456|SUPERIORITY|||||||0.08|||||||One sample z-test|one-sided 0.025 significance level||≤35% was considered acceptable, ≥55% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used. For a given arm, if the null hypothesis of p ≤ 0.35 is rejected, then conclude that the regimen given on that arm is unacceptable. However if it not rejected for both bowel \& urinary domains, then that regimen will be considered acceptable for further use in a Phase III study.||||0.08
70884968|NCT01434290|141255457|SUPERIORITY|||||||0.18|||||||One sample z-test|One-sided 0.025 significance level||≤40% was considered acceptable, ≥60% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used. For a given arm, if the null hypothesis of p ≤ 0.40 is rejected, then conclude that the regimen given on that arm is unacceptable. However if it not rejected for both bowel \& urinary domains, then that regimen will be considered acceptable for further use in a Phase III study.||||0.18
70884969|NCT01434290|141255457|SUPERIORITY|||||||0.38|||||||One sample z-test|One-sided 0.025 significance level||≤40% was considered acceptable, ≥60% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used. For a given arm, if the null hypothesis of p ≤ 0.40 is rejected, then conclude that the regimen given on that arm is unacceptable. However if it not rejected for both bowel \& urinary domains, then that regimen will be considered acceptable for further use in a Phase III study.||||0.38
70884970|NCT01434290|141255462|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||\[Bowel one-year results\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the normality of the data.||||0.03
70884971|NCT01434290|141255462|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||\[Bowel one-year results\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the normality of the data.||||0.03
70884972|NCT01434290|141255462|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017||\[Urinary one-year results\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the normality of the data.||||0.09
70884973|NCT01434290|141255462|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|Two-side significance level of 0.017||\[Urinary one-year results\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the normality of the data.||||0.43
70884974|NCT01434290|141255463|SUPERIORITY|||||||0.39|||||||One-sample z-test|One-sided 0.025 significance level||≤35% was considered acceptable, ≥55% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used.||||0.39
70884975|NCT01434290|141255463|SUPERIORITY|||||||0.21|||||||One sample z-test|One-side significance level of 0.025||≤35% was considered acceptable, ≥55% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used.||||0.21
70884976|NCT01434290|141255464|SUPERIORITY|||||||0.44|||||||one sampe z-test|One-sided significance level of 0.025||≤38% was considered acceptable, ≥58% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used.||||0.44
70884977|NCT01434290|141255464|SUPERIORITY|||||||0.53|||||||One sample z-test|One-sided significance level of 0.025||≤38% was considered acceptable, ≥58% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used.||||0.53
70884978|NCT01434290|141255465|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||\[One-year Index Score\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the non-normality of the data. Each arm analyzed separately.||||0.16
70884979|NCT01434290|141255465|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||\[One-year Index Score\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the non-normality of the data. Each arm analyzed separately.||||0.03
70884980|NCT01434290|141255465|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||\[One-year VAS Score\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the non-normality of the data. Each arm analyzed separately.||||0.83
70884981|NCT01434290|141255465|SUPERIORITY|||||||0.86|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||\[One-year VAS Score\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the non-normality of the data. Each arm analyzed separately.||||0.86
70884982|NCT03465878|141255480|SUPERIORITY||Ratio of geometric least squares means|0.999||||0.9813|TWO_SIDED|95.0|0.918|1.09|||Mixed Models Analysis|||||1.09|0.918|0.9813
70884983|NCT03465878|141255480|SUPERIORITY||Ratio of geometric least squares means|1.06||||0.1638|TWO_SIDED|95.0|0.976|1.15|||Mixed Models Analysis|||||1.15|0.976|0.1638
70884984|NCT03465878|141255480|SUPERIORITY||Ratio of geometric least squares means|1.01||||0.7623|TWO_SIDED|95.0|0.933|1.1|||Mixed Models Analysis|||||1.10|0.933|0.7623
70884985|NCT03465878|141255480|SUPERIORITY||Ratio of geometric least squares means|1.04||||0.2952|TWO_SIDED|95.0|0.962|1.13|||Mixed Models Analysis|||||1.13|0.962|0.2952
70884986|NCT03465878|141255480|SUPERIORITY||Ratio of geometric least squares means|0.97||||0.4052|TWO_SIDED|95.0|0.901|1.04|||Mixed Models Analysis|||||1.04|0.901|0.4052
70884987|NCT03465878|141255480|SUPERIORITY||Ratio of geometric least squares means|1.02||||0.5314|TWO_SIDED|95.0|0.948|1.11|||Mixed Models Analysis|||||1.11|0.948|0.5314
70884988|NCT01806896|141255536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|1.68||0.68|TWO_SIDED|90.0|-3.56|2.15||2-sided p-value|ANCOVA|Treatment differences are based on a mixed effect model including treatment as fixed effects and baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Day 28)||2.15|-3.56|0.68
70884989|NCT01806896|141255538|SUPERIORITY_OR_OTHER||Least square mean|-0.1|STANDARD_ERROR_OF_MEAN|0.36||0.79|TWO_SIDED|90.0|-0.72|0.52||2-sided p-value|ANCOVA|Treatment differences are based on a mixed effect model including treatment as fixed effect and baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Cue Rew\>Neut Left VS)||0.52|-0.72|0.79
70884990|NCT01806896|141255538|SUPERIORITY_OR_OTHER||Least square mean|-0.15|STANDARD_ERROR_OF_MEAN|0.37||0.7|TWO_SIDED|90.0|-0.8|0.51||2-sided p-value|ANCOVA|Treatment differences are based on a mixed effect model including treatment as fixed effect and baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Cue Rew\>Neut Right VS)||0.51|-0.80|0.70
70884991|NCT01806896|141255538|SUPERIORITY_OR_OTHER||Least square mean|-0.25|STANDARD_ERROR_OF_MEAN|0.37||0.51|TWO_SIDED|90.0|-0.89|0.4||2-sided p-value|ANCOVA|Treatment differences are based on a mixed effect model including treatment as fixed effect and baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Out\_win\_Rew\>Out\_win N Left VS)||0.40|-0.89|0.51
70884992|NCT01806896|141255538|SUPERIORITY_OR_OTHER||Least square mean|-0.53|STANDARD_ERROR_OF_MEAN|0.33||0.13|TWO_SIDED|90.0|-1.1|0.04||2-sided p-value|ANCOVA|Treatment differences are based on a mixed effect model including treatment as fixed effect and baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Out\_win\_Rew\>Out\_win N Right VS)||0.04|-1.10|0.13
70884993|NCT01806896|141255541|SUPERIORITY_OR_OTHER||Least square mean|7.3|STANDARD_ERROR_OF_MEAN|3.57||0.04|TWO_SIDED|90.0|1.43|13.18||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment\*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Emotional Incentive-Neutral) Day 28||13.18|1.43|0.04
70884994|NCT01806896|141255541|SUPERIORITY_OR_OTHER||Least square mean|7.57|STANDARD_ERROR_OF_MEAN|3.57||0.03|TWO_SIDED|90.0|1.69|13.45||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment\*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Emotional Incentive-Positive) Day 28||13.45|1.69|0.03
70884995|NCT01806896|141255541|SUPERIORITY_OR_OTHER||Least square mean|7.28|STANDARD_ERROR_OF_MEAN|3.56||0.04|TWO_SIDED|90.0|1.41|13.15||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment\*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Emotional Incentive-Negative) Day 28||13.15|1.41|0.04
70884996|NCT01806896|141255541|SUPERIORITY_OR_OTHER||Least square mean|0.98|STANDARD_ERROR_OF_MEAN|3.58||0.78|TWO_SIDED|90.0|-4.91|6.87||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment\*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Monetary Incentive-0.01 Euro) Day 28||6.87|-4.91|0.78
70884997|NCT01806896|141255541|SUPERIORITY_OR_OTHER||Least square mean|4.78|STANDARD_ERROR_OF_MEAN|3.58||0.18|TWO_SIDED|90.0|-1.11|10.67||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment\*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Monetary Incentive-0.1 Euro) Day 28||10.67|-1.11|0.18
70884998|NCT01806896|141255541|SUPERIORITY_OR_OTHER||Least square mean|16.35|STANDARD_ERROR_OF_MEAN|3.58|<|0.01|TWO_SIDED|90.0|10.46|22.24||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment\*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Monetary Incentive-1 Euro) Day 28||22.24|10.46|<0.01
70884999|NCT01896895|141255573|SUPERIORITY||LS mean difference|-1.2|||=|0.0004|TWO_SIDED|95.0|-1.9|-0.6|||ANCOVA|||The difference in change of JRS severity subscore between treatment groups was analyzed by an ANCOVA according to a hierarchical test procedure. First step of hierarchy is hypothesis of superiority of 50 unit dose group NT 201 compared to placebo. This was tested confirmatory (α=0.05, 2-sided) by an ANCOVA with treatment group, pooled site, and gender as fixed factors and baseline JRS severity subscore and age as covariates based on LS means comparison. Missing values were imputed by LOCF.||-0.6|-1.9|=0.0004
70885000|NCT01896895|141255573|SUPERIORITY||LS mean difference|-0.5|||=|0.1452|TWO_SIDED|95.0|-1.1|0.2|||ANCOVA|||The difference in change of JRS severity subscore between treatment groups was analyzed by an ANCOVA according to a hierarchical test procedure. Second step of hierarchy is hypothesis of superiority of 25 unit dose group NT 201 compared to placebo. This was tested confirmatory (α=0.05, 2-sided) by an ANCOVA with treatment group, pooled site, and gender as fixed factors and baseline JRS severity subscore and age as covariates based on LS means comparison. Missing values were imputed by LOCF.||0.2|-1.1|=0.1452
70885001|NCT04127786|141255576|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95 percent (%) confidence interval (CI) of the difference of the percentages between the test group (Group 1) and control groups (Group 2, Group 3) was greater than (\>) -5% at Day 42.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.4|4.3||||||Primary Series: Cohort-I Group 1: VRVg-2 versus Primary Series: Cohort-I Group 2: Verorab®: Pediatric (\< 18 years)||4.3|-1.4|
70885002|NCT04127786|141255576|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentages between the test group (Group 1) and control groups (Group 2, Group 3) was \> -5% at Day 42.|Percentage Difference|1.2|||||TWO_SIDED|95.0|-0.6|6.4||||||Primary Series: Cohort-I Group 1: VRVg-2 versus Primary Series: Cohort-I Group 2: Verorab®: Adult (\>=18 years)||6.4|-0.6|
70885003|NCT04127786|141255576|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentages between the test group (Group 1) and control groups (Group 2, Group 3) was \> -5% at Day 42.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.4|4.4||||||Primary Series: Cohort-I Group 1: VRVg-2 versus Primary Series: Cohort-I Group 3: Imovax Rabies: Pediatric (\< 18 years)||4.4|-1.4|
70885004|NCT04127786|141255576|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentages between the test group (Group 1) and control groups (Group 2, Group 3) was \> -5% at Day 42.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.5|4.6||||||Primary Series: Cohort-I Group 1: VRVg-2 versus Primary Series: Cohort-I Group 3: Imovax Rabies: Adult (\>= 18 years)||4.6|-1.5|
70885005|NCT04127786|141255577|SUPERIORITY|If the non-inferiority for VRVg-2 versus comparator vaccines was reached at Day 42, then superiority was demonstrated if the overall observed percentage of participants with an RVNA titer \>= 0.5 IU/mL at Day 42 was at least 99% in the VRVg-2 Group, with the lower limit of the 95% CI at least 97%.|Percentage Difference|100.0|||||TWO_SIDED|95.0|99.3|100.0||||||The secondary immunogenicity outcome measures were evaluated sequentially following a fixed-sequence method.||100|99.3|
70885006|NCT04127786|141255578|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between the test groups (Groups 1+4) and control groups (Groups 2+5, Groups 3+6) was \> -5% at Day 28.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.4|4.3||||||Pooled Groups 1 and 4: VRVg-2 versus Pooled Groups 2 and 5: Verorab®: Pediatric (\< 18 years)||4.3|-1.4|
70885007|NCT04127786|141255578|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between the test groups (Groups 1+4) and control groups (Groups 2+5, Groups 3+6) was \> -5% at Day 28.|Percentage Difference|-0.2|||||TWO_SIDED|95.0|-1.9|2.7||||||Pooled Groups 1 and 4: VRVg-2 versus Pooled Groups 2 and 5: Verorab®: Adult (\>=18 years)||2.7|-1.9|
70885008|NCT04127786|141255578|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between the test groups (Groups 1+4) and control groups (Groups 2+5, Groups 3+6) was \> -5% at Day 28.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.4|4.5||||||Pooled Groups 1 and 4: VRVg-2 versus Pooled Groups 3 and 6: Imovax Rabies®: Pediatric (\< 18 years)||4.5|-1.4|
70885009|NCT04127786|141255578|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between the test groups (Groups 1+4) and control groups (Groups 2+5, Groups 3+6) was \> -5% at Day 28.|Percentage Difference|1.8|||||TWO_SIDED|95.0|-0.5|5.3||||||Pooled Groups 1 and 4: VRVg-2 versus Pooled Groups 3 and 6: Imovax Rabies®: Adult (\>= 18 years)||5.3|-0.5|
70885010|NCT04127786|141255579|NON_INFERIORITY|If the non-inferiority objective for VRVg-2 versus comparator vaccines at Day 28 was demonstrated, the overall non-inferiority of 2-dose VRVg-2 at Day 28 versus 3-dose Imovax Rabies® at Day 42 was demonstrated if the non-inferiority between pooled Groups 1+4 and Group 3 were both demonstrated in each age group.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.4|4.4|||||Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between 2-dose VRVg-2 at Day 28 and 3-dose Imovax Rabies® at Day 42 was \> -10%.|Pooled Groups 1 and 4: VRVg-2 at Day 28 versus Primary Series: Cohort-1 Group 3: Imovax Rabies® at Day 42: Pediatric (\< 18 years)||4.4|-1.4|
70885011|NCT04127786|141255579|NON_INFERIORITY|If the non-inferiority objective for VRVg-2 versus comparator vaccines at Day 28 was demonstrated, the overall non-inferiority of 2-dose VRVg-2 at Day 28 versus 3-dose Imovax Rabies® at Day 42 was demonstrated if the non-inferiority between pooled Groups 1+4 and Group 3 were both demonstrated in each age group.|Percentage Difference|-1.7|||||TWO_SIDED|95.0|-3.1|3.0|||||Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between 2-dose VRVg-2 at Day 28 and 3-dose Imovax Rabies® at Day 42 was \> -10%.|Pooled Groups 1 and 4: VRVg-2 at Day 28 versus Primary Series: Cohort-1 Group 3: Imovax Rabies® at Day 42: Adult (\>= 18 years)||3.0|-3.1|
70885012|NCT04127786|141255581|NON_INFERIORITY|If the superiority objective of VRVg-2 was reached at Day 28, the non-inferiority of 2-dose Imovax Rabies® at Day 28 versus 3-dose Imovax Rabies® at Day 42 was demonstrated if the lower limit of the 95% CI of the difference of the percentage between the 2-dose Imovax Rabies® at Day 28 and 3-dose Imovax Rabies® at Day 42 was \> -10%.|Percentage Difference|-1.3|||||TWO_SIDED|95.0|-4.4|1.3||||||Imovax Rabies® at Day 28 versus Imovax Rabies® at Day 42||1.3|-4.4|
70885013|NCT01904604|141255606|SUPERIORITY_OR_OTHER||Risk Difference (RD)|33.8||||0.005|TWO_SIDED|33.8|10.2|57.5||A one-sided test was used with the a priori threshold for statistical significance of 0.0125. No adjustments were made to the p-value.|Barnard's statistic|||The null hypothesis was that there was no difference between treatment groups. Subjects who did not complete the Week 52 oral food challenge were counted as treatment failures.||57.5|10.2|0.005
70885014|NCT01904604|141255606|SUPERIORITY_OR_OTHER||Risk Difference (RD)|36.0||||0.003|TWO_SIDED|36.0|12.6|59.4||A one-sided test was used with the a priori threshold for statistical significance of 0.0125. No adjustments were made to the p-value.|Barnard's statistic|||The null hypothesis was that there was no difference between treatment groups. Subjects who did not complete the Week 52 oral food challenge were counted as treatment failures.||59.4|12.6|0.003
70885015|NCT01904604|141255606|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.2||||0.48|TWO_SIDED|2.2|-25.8|30.1||A one-sided test was used with the a priori threshold for statistical significance of 0.0125. No adjustments were made to the p-value.|Barnard's statistic|||||30.1|-25.8|0.48
70885016|NCT01904604|141255610|SUPERIORITY_OR_OTHER|||||||0.8||||||No adjustments were made to the p-value.|Wilcoxon (Mann-Whitney)|The two-sided t approximation was used.||The null hypothesis was that there was no difference between treatment groups.||||0.80
70885017|NCT01904604|141255610|SUPERIORITY_OR_OTHER|||||||0.008||||||No adjustments were made to the p-value.|Wilcoxon (Mann-Whitney)|The two-sided t approximation was used.||The null hypothesis was that there was no difference between treatment groups.||||0.008
70885018|NCT01904604|141255610|SUPERIORITY_OR_OTHER|||||||0.01||||||No adjustments were made to the p-value.|Wilcoxon (Mann-Whitney)|The two-sided t approximation was used.||The null hypothesis was that there was no difference between treatment groups.||||0.01
70885019|NCT05124665|141255614|EQUIVALENCE|Hypothesis is that proportion of contacts accepting HIV testing between two study arms is equivalent.|Odds Ratio (OR)|4.6||||0.004|TWO_SIDED|95.0|1.6|12.9|||Mixed Models Analysis|Cluster adjusted for household.||||12.9|1.6|0.004
70885020|NCT05124665|141255614|EQUIVALENCE|Hypothesis is proportion of contacts accepting HIV testing is equivalent between the two study arms|Mean Difference (Net)|6.0||||0.006|TWO_SIDED|95.0|2.0|10.0|||t-test, 2 sided||Estimated value and confidence interval reflects the values multiplied by 100 (converting decimal to percentage).|||10|2|0.006
70885021|NCT05124665|141255615|EQUIVALENCE|Hypothesis is that the change in stigma score is equivalent between the two study arms.|Slope|2.2||||0.358|TWO_SIDED|95.0|-2.5|6.9|||Mixed Models Analysis|||Van Rie Perceived TB and HIV Stigma scales adapted and validated in the Ugandan context are used. Scores range from 0 to 100 (standardized scale)||6.9|-2.5|0.358
70885022|NCT05124665|141255616|EQUIVALENCE|Hypothesis is that the difference in stigma score is equivalent between the two study arms|Slope|2.61||||0.199|TWO_SIDED|95.0|-1.38|6.59|||Mixed Models Analysis|||||6.59|-1.38|0.199
70885023|NCT05124665|141255617|EQUIVALENCE|Hypothesis is no effect from perceived HIV Stigma on HIV Test Uptake|Coefficient from Structural Equation|0.00087||||0.03|TWO_SIDED|95.0|0.00007|0.00167|||Structural Equation Modeling|||||0.00167|0.00007|0.03
70885024|NCT05124665|141255618|EQUIVALENCE|Hypothesis is that TB stigma has no effect of HIV test uptake|Coefficient Structural Equation Model|0.0002||||0.64|TWO_SIDED|95.0|-0.0007|0.0011|||Structural Equation Modeling|||||0.0011|-0.0007|0.64
70885025|NCT05124665|141255619|EQUIVALENCE|Hypothesis is that proportion of index patient nominated household contacts accepting HIV testing is equivalent between two study arms||||||0.452|||||||Chi-squared|||||||0.452
70885026|NCT05124665|141255620|NON_INFERIORITY|Hypothesis is that the first tester's decision to test does not impact subsequent household contacts decision to test for HIV.|Risk Ratio (RR)|1.23||||0.264|TWO_SIDED|95.0|0.86|1.76|||Regression, Logistic|||||1.76|0.86|0.264
70885027|NCT05124665|141255621|EQUIVALENCE|Hypothesis is that the index patient and contact nominations will match equally regardless of study arm.|||||<|0.001|||||||Chi-squared|||||||<0.001
70885028|NCT04144166|141255636|OTHER||||||||||||||See above|||"Mean value for visual CRT and median value for device CRI were calculated for each participant. 3 values were measured (each) for CRT and CRI. Mean value is equal to SUM(m1,m2,m3)/3.~Median value was then calculated for the set (57) of calculated mean visual CRT and mean device CRI. Median value is equal to the middle value of the series of mean values. All measurements are in units of seconds."|See above|||
70885029|NCT01481116|141255652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.13|||<|0.001|TWO_SIDED|95.0|0.09|0.18||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Regression, Logistic|||Day 1 up to Week 78: Odds Ratios, corresponding confidence interval, and p-values were calculated using logistic regression with factors for treatment, country, schedule and baseline HbA1c value.||0.18|0.09|<0.001
70885030|NCT01481116|141255652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.13|||<|0.001|TWO_SIDED|95.0|0.09|0.18||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Regression, Logistic|||Day 1 up to Week 78: Odds Ratios, corresponding confidence interval, and p-values were calculated using logistic regression with factors for treatment, country, schedule and baseline HbA1c value.||0.18|0.09|<0.001
70885031|NCT01481116|141255652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.13|||<|0.001|TWO_SIDED|95.0|0.09|0.18||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Regression, Logistic|||Day 1 up to Week 104: Odds Ratios, corresponding confidence interval, and p-values were calculated using logistic regression with factors for treatment, country, schedule and baseline HbA1c value.||0.18|0.09|<0.001
70885032|NCT01481116|141255652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.13|||<|0.001|TWO_SIDED|95.0|0.09|0.18||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Regression, Logistic|||Day 1 up to Week 104: Odds Ratios, corresponding confidence interval, and p-values were calculated using logistic regression with factors for treatment, country, schedule and baseline HbA1c value.||0.18|0.09|<0.001
70885033|NCT01481116|141255653|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.707||0.065|TWO_SIDED|95.0|-2.7|0.08||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Mixed Model Repeated Measures|Treatment, schedule and visit-by-treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates.||Change at Week 78||0.08|-2.70|0.065
70885034|NCT01481116|141255653|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|0.678||0.034|TWO_SIDED|95.0|-2.78|-0.11||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Mixed Model Repeated Measures|Treatment, schedule and visit-by-treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates.||Change at Week 78||-0.11|-2.78|0.034
70885035|NCT01956110|141255706|NON_INFERIORITY|The lower bound of the 95% CI was well above the pre-specified non-inferiority limit of -8.0%. Thus, non-inferiority of FE 999049 to GONAL-F with regard to ongoing pregnancy rate was demonstrated.|Treatment difference|-0.9|||||TWO_SIDED|95.0|-5.9|4.1||||||The pre-specified non-inferiority margin was -8.0% (absolute). Non-inferiority was evaluated based on a two-sided 95% confidence interval (CI) derived based on the asymptotic normal distribution. The treatment comparison was adjusted for age (\<35, 35-37 and 38-40 years) by using the Mantel-Haenszel method to combine results across age-strata.||4.1|-5.9|
70963552|NCT00578786|141431981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.0|STANDARD_DEVIATION|84.38|||TWO_SIDED|95.0|10.9|45.1|||||Applies to Ambrisentan 10 mg group only. LOCF method of imputation.|||45.1|10.9|
70885036|NCT01956110|141255707|NON_INFERIORITY|The lower bound of the 95% CI was well above the pre-specified non-inferiority limit of -8.0%. Thus, non-inferiority of FE 999049 to GONAL-F with regard to ongoing implantation rate was demonstrated.|Treatment difference|-0.6|||||TWO_SIDED|95.0|-6.1|4.8||||||The pre-specified non-inferiority margin was -8.0% (absolute). Non-inferiority was evaluated based on a two-sided 95% CI derived based on the asymptotic normal distribution. The treatment comparison was adjusted for age (\<35, 35-37 and 38-40 years) by using the Mantel-Haenszel method to combine results across age-strata.||4.8|-6.1|
70885037|NCT01956110|141255708|NON_INFERIORITY|The lower bound of the 95% CI was well above -8.0% (pre-specified non-inferiority limit for the co-primary endpoints). Thus, the result was supportive of the co-primary endpoint analyses.|Treatment difference|-1.6|||||TWO_SIDED|95.0|-6.7|3.4||||||Treatment groups were compared using a two-sided 95% CI derived based on the asymptotic normal distribution. The treatment comparison was adjusted for age (\<35, 35-37 and 38-40 years) by using the Mantel-Haenszel method to combine results across age-strata.||3.4|-6.7|
70885038|NCT01956110|141255709|NON_INFERIORITY|The lower bound of the 95% CI was well above -8.0% (pre-specified non-inferiority limit for the co-primary endpoints). Thus, the result was supportive of the co-primary endpoint analyses.|Treatment difference|-1.4|||||TWO_SIDED|95.0|-7.0|4.2||||||Treatment groups were compared using a two-sided 95% CI derived based on the asymptotic normal distribution. The treatment comparison was adjusted for age (\<35, 35-37 and 38-40 years) by using the Mantel-Haenszel method to combine results across age-strata.||4.2|-7.0|
70885039|NCT01956110|141255710|OTHER|A logistic regression model was fitted to the data including AMH, log(AMH)\^2, treatment group and interactions between treatment group and AMH and treatment group and log(AMH)\^2 in the linear predictor. A second logistic regression model (nested within the first model) was fitted including AMH and log(AMH)\^2 in the linear predictor.|||||=|0.001||||||Inclusion of treatment provides a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: \<4 or \>=15 oocytes retrieved||||=0.001
70885040|NCT01956110|141255710|OTHER|A logistic regression model was fitted to the data including AMH, log(AMH)2, treatment group and interactions between treatment group and AMH and treatment group and log(AMH)\^2 in the linear predictor. A second logistic regression model (nested within the first model) was fitted including AMH and log(AMH)\^2 in the linear predictor.|||||=|0.002||||||Inclusion of treatment provides a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: \<4 or \>=20 oocytes retrieved||||=0.002
70885041|NCT01956110|141255711|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.|||||=|0.291||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Early OHSS (any grade)||||=0.291
70885042|NCT01956110|141255711|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.|||||=|0.644||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Early OHSS (moderate/severe)||||=0.644
70885043|NCT01956110|141255711|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.|||||=|0.005||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Preventive interventions||||=0.005
70885044|NCT01956110|141255711|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.|||||=|0.046||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Early OHSS (any grade) and/or preventive interventions||||=0.046
70885045|NCT01956110|141255711|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.|||||=|0.019||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Early OHSS (moderate/severe) and/or preventive interventions||||=0.019
70885046|NCT01956110|141255712|EQUIVALENCE|Treatment groups were compared using a logistic regression model with treatment and age (\<35, 35- 37, and 38-40 years) as factors.|Odds Ratio (OR)|1.38|||=|0.302|TWO_SIDED|95.0|0.74|2.57||P-value corresponds to test for treatment difference.|Likelihood ratio test|||Treatment comparison: Cycle cancelled due to poor response||2.57|0.74|=0.302
70885047|NCT01956110|141255712|EQUIVALENCE|Treatment groups were compared using a logistic regression model with treatment and age (\<35, 35-37, and 38-40 years) as factors.|Odds Ratio (OR)|0.42||||0.019|TWO_SIDED|95.0|0.2|0.9||P-value corresponds to test for treatment difference.|Likelihood ratio test|||Treatment comparison:Triggering with GnRH agonist||0.9|0.2|0.019
70885048|NCT01956110|141255713|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.692|||||||van Elteren|||Treatment comparison: Number of oocytes retrieved||||=0.692
70963553|NCT00578786|141431981|SUPERIORITY_OR_OTHER||Median Difference (Net)|20.3|STANDARD_DEVIATION|96.05|||TWO_SIDED|95.0|10.6|30.1|||||Applies to Ambrisentan combined group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||30.1|10.6|
70885049|NCT01956110|141255714|OTHER|"A logistic regression model was fitted to the data including AMH, log(AMH)\^2, treatment group and interactions between treatment group and AMH and treatment group and log(AMH)\^2 in the linear predictor.~A second logistic regression model (nested within the first model) was fitted including AMH and log(AMH)\^2 in the linear predictor."|||||=|0.019||||||Inclusion of treatment provides a better fit to the data|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||The relation between ovarian response potential (AMH at screening) and probability of achieving the targeted response was modelled using logistic regression models.||||=0.019
70885050|NCT01956110|141255715|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.909|||||||van Elteren|||Treatment comparison: Number of metaphase II oocytes||||=0.909
70885051|NCT01956110|141255716|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).||||||0.53|||||||van Elteren|||Treatment comparison: Fertilisation rate||||0.53
70885052|NCT01956110|141255717|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.59|||||||van Elteren|||Treatment comparison: Number of embryos||||=0.59
70885053|NCT01956110|141255717|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.414|||||||van Elteren|||Treatment comparison: Good quality embryos||||=0.414
70885054|NCT01956110|141255718|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.344|||||||van Elteren|||Treatment comparison: Number of blastocysts||||= 0.344
70885055|NCT01956110|141255718|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.58|||||||van Elteren|||Treatment comparison: Good-quality blastocysts||||= 0.58
70885056|NCT01956110|141255719|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||<|0.001|||||||van Elteren|||Treatment comparison: Total gonadotropin dose||||<0.001
70885057|NCT01956110|141255720|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.062|||||||van Elteren|||Treatment comparison: Number of stimulation days||||=0.062
70885058|NCT01956110|141255721|EQUIVALENCE|Treatment groups were compared using a chi-square test.|||||=|0.178|||||||Chi-squared|||Treatment comparison: Investigator-requested gonadotropin dose adjustments||||=0.178
70885059|NCT01956110|141255727|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.||||||0.32||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Late OHSS (any grade)||||0.320
70885060|NCT01956110|141255727|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.||||||0.39||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Late OHSS (moderate/severe)||||0.390
70885061|NCT03400332|141255810|OTHER||Hazard Ratio, log|0.94||||0.7416|TWO_SIDED|95.0|0.61|1.45|||Log Rank|||||1.45|0.61|0.7416
70885062|NCT02704364|141255828|SUPERIORITY||Hodges-Lehmann estimate|-14.0|STANDARD_ERROR_OF_MEAN|21.4||0.434|TWO_SIDED|95.0|-68.0|28.0|||Wilcoxon (Mann-Whitney)|||||28.0|-68.0|0.434
70885063|NCT02704364|141255828|SUPERIORITY||Hodges-Lehmann estimate|13.0|STANDARD_ERROR_OF_MEAN|25.0||0.646|TWO_SIDED|95.0|-41.0|71.0|||Wilcoxon (Mann-Whitney)|||||71.0|-41.0|0.646
70885064|NCT02107599|141255861|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Asymptotic Z-test|||||||0.0001
70885065|NCT02107599|141255862|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Monte Carlo test|||Evaluate whether the VisQ interpretation significantly improves the reliability of Amyvid Scan interpretation.||||0.0060
70885066|NCT02107599|141255862|SUPERIORITY_OR_OTHER|||||||0.1229|TWO_SIDED||||||Monte Carlo test|||Evaluate whether the VisQ interpretation significantly improves the reliability of Amyvid Scan interpretation.||||0.1229
70885067|NCT02107599|141255862|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED||||||Monte Carlo test|||Evaluate whether the VisQ interpretation significantly improves the reliability of Amyvid Scan interpretation.||||0.0260
70885068|NCT05583903|141255890|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
70885069|NCT05583903|141255891|SUPERIORITY|||||||0.26|||||||Fisher Exact|||||||0.26
70885070|NCT05583903|141255892|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
70885071|NCT05583903|141255893|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
70885072|NCT05583903|141255894|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
70885073|NCT05583903|141255895|SUPERIORITY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||||||0.21
70885074|NCT05583903|141255896|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||0.66
70885075|NCT05583903|141255897|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
70885076|NCT05583903|141255898|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||||||0.71
70885077|NCT05583903|141255899|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
70885078|NCT05583903|141255900|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
70885079|NCT05583903|141255901|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||||||0.23
70885080|NCT05583903|141255902|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
70885081|NCT05583903|141255903|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||||||0.52
70885082|NCT05583903|141255904|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
70885083|NCT01103934|141255919|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.09
70885084|NCT01103934|141255920|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.04
70963554|NCT00578786|141431982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7|STANDARD_DEVIATION|95.21|||TWO_SIDED|95.0|-18.9|20.3|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||20.3|-18.9|
70885085|NCT02402452|141255923|OTHER||Geometric Least-Square Mean(GLSM)Ratio %|172.92|||||TWO_SIDED|90.0|97.93|305.33||||||An analysis of variance (ANOVA) appropriate for a parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUClast. A 90% confidence interval (CI) was constructed for the geometric least squares mean (GLSM) ratio of AUClast for the comparison groups using two 1-sided tests.||305.33|97.93|
70885086|NCT02402452|141255924|OTHER||GLSM Ratio (%)|171.27|||||TWO_SIDED|90.0|97.65|300.38||||||An ANOVA appropriate for parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUCinf. A 90% CI was constructed for the GLSM ratio of AUCinf for the comparison groups using two 1-sided tests.||300.38|97.65|
70885087|NCT02402452|141255925|OTHER||GLSM Ratio (%)|145.43|||||TWO_SIDED|90.0|83.77|252.48||||||An ANOVA appropriate for parallel design was fitted to the natural logarithmic transformation of voxilaprevir Cmax. A 90% CI was constructed for the GLSM ratio of Cmax for the comparison groups using two 1-sided tests.||252.48|83.77|
70885088|NCT00559962|141255934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.68|||<|0.001|TWO_SIDED|95.0|2.3|7.07|||ANOVA|||One-way analysis of variance (ANOVA) to compare the absolute change from baseline to Week 12 in percent hepatic fat between AEGR-755 5 mg and placebo.||7.07|2.30|<0.001
70885089|NCT00559962|141255935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.92|||<|0.001|TWO_SIDED|95.0|2.27|7.57||(All comparisons)|ANOVA|||One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo||7.57|2.27|<0.001
70885090|NCT00559962|141255935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.68|||<|0.001|TWO_SIDED|95.0|2.3|7.07||(All comparisons)|ANOVA|||||7.07|2.30|<0.001
70885091|NCT00559962|141255935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.91|||<|0.001|TWO_SIDED|95.0|1.73|6.1||(All comparisons)|ANOVA|||One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo||6.10|1.73|<0.001
70885092|NCT00559962|141255935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.82|||<|0.001|TWO_SIDED|95.0|4.31|11.33||(All comparisons)|ANOVA|||||11.33|4.31|<0.001
70885093|NCT00559962|141255935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.65|||<|0.001|TWO_SIDED|95.0|1.58|5.72||(All comparisons)|ANOVA|||One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo||5.72|1.58|<0.001
70885094|NCT00559962|141255935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.66|||<|0.001|TWO_SIDED|95.0|4.22|11.11||(All comparisons)|ANOVA|||One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo||11.11|4.22|<0.001
70885095|NCT00559962|141255935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.51|||<|0.001|TWO_SIDED|95.0|5.16|9.86||(All comparisons)|ANOVA|||One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo||9.86|5.16|<0.001
70885096|NCT05422053|141255948|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||End of Control-IQ Use (13 Weeks) compared to Control-IQ Start||||<0.001
70885097|NCT04382911|141255985|EQUIVALENCE|A 2x2 table was constructed among all patients with histopathologically identified endometriosis (true positive) to compare sensitivity for FES PET/MRI versus sensitivity of conventional MRI.||||||0.317|||||||McNemar|||||||0.317
70885098|NCT04382911|141255988|OTHER|A random effects linear regression model, modeling SUV-max as a function of the pain rating, while controlling for patient-level covariates (BMI, race, age) was performed. The investigators included physician as a random effect to account for physician-level correlation.|Slope|0.748||||0.24|TWO_SIDED||||||Pearson's Correlation Coefficient|||||||0.24
70885099|NCT04382911|141255988|OTHER|The investigators will implement a random effects linear regression model, modeling SUV-max as a function of EHP-30, while controlling for patient-level covariates (BMI, race, age). The investigators will include physician as a random effect to account for physician-level correlation.|Slope|0.406||||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.13
70885100|NCT00376168|141256020|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||one-sample t-test|one-sample t-test (combined) to test the null hypothesis that percent change = 0||"The primary efficacy analysis was based on two one-sample t-tests (one for each treatment group) to determine if the percent change in spleen volume is different than zero.~With 12 patients in each treatment group, there was greater than 95% power to detect a change of 20% or more using a one-sample t-test (alpha=0.025, 2-sided test to allow for each group to be tested separately) to evaluate the primary outcome of percent change in spleen volume after nine months."||||<0.0001
70885101|NCT00376168|141256020|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||threshold for statistical significance = 0.025|one-sample t-test|one-sample t-test (combined) to test the null hypothesis that percent change = 0||"The primary efficacy analysis was based on two one-sample t-tests (one for each treatment group) to determine if the percent change in spleen volume is different than zero.~With 12 patients in each treatment group, there was greater than 95% power to detect a change of 20% or more using a one-sample t-test (alpha=0.025, 2-sided test to allow for each group to be tested separately) to evaluate the primary outcome of percent change in spleen volume after nine months."||||<0.0001
70885102|NCT00376168|141256021|SUPERIORITY_OR_OTHER|||||||0.0041||95.0|||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.||||0.0041
70885103|NCT00376168|141256021|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.||||<0.0001
70885104|NCT00376168|141256022|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.||||0.0010
70885105|NCT00376168|141256022|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.||||<0.0001
70885106|NCT00376168|141256023|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.||||0.0460
70885107|NCT00376168|141256023|SUPERIORITY_OR_OTHER|||||||0.0031||95.0|||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.||||0.0031
70885108|NCT02350309|141256025|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.15||||0.0262|ONE_SIDED|95.0|-2.12|||The mixed model included treatment, period and sequence as fixed effects, baseline (predose) measurement as a covariate, and participant nested within treatment sequence as a random effect.|Mixed Models Analysis||||||-2.12|0.0262
70885109|NCT02350309|141256025|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.48|||<|0.0001|ONE_SIDED|95.0|-4.46|||The mixed model included treatment, period and sequence as fixed effects, baseline (predose) measurement as a covariate, and participant nested within treatment sequence as a random effect.|Mixed Models Analysis||||||-4.46|<0.0001
70885110|NCT02350309|141256026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0215||||||P-value was calculated based on non-missing two-way contingency table between placebo and study treatment.|McNemar|||||||0.0215
70885111|NCT02350309|141256026|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||P-value was calculated based on non-missing two-way contingency table between placebo and study treatment.|McNemar|||||||<0.0001
70885112|NCT02350309|141256026|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||P-value was calculated based on non-missing two-way contingency table between placebo and study treatment.|McNemar|||||||<0.0001
70885113|NCT04399161|141256045|SUPERIORITY|||||||0.123|||||||ANOVA|||Comparison among Children||||0.123
70885114|NCT04399161|141256045|SUPERIORITY|||||||0.314|||||||ANOVA|||Comparison among Elderly||||0.314
70885115|NCT02800148|141256054|EQUIVALENCE|provides 85% power of success|equivalence ratio|107.0|||||TWO_SIDED|90.0|96.1|115.5||No p-value as calculated for bioequivalence, just a T/R ratio and 90% confidence interval|Fieller's method|||||115.5|96.1|
70885116|NCT00739752|141256061|SUPERIORITY||Risk Ratio (RR)|0.99|||=|0.885|TWO_SIDED|95.0|0.88|1.12|||Regression, Poisson|||The two gain-framed groups were compared to the two loss-framed groups using poisson regression.||1.12|.88|=.885
70885117|NCT00739752|141256061|SUPERIORITY||Risk Ratio (RR)|1.17|||<|0.01|TWO_SIDED|95.0|1.06|1.31|||Regression, Poisson|||Groups receiving any framed interventions (gain-framed or loss-framed) were compared to those in the two non-framed control groups.||1.31|1.06|<.01
70885118|NCT00739752|141256061|SUPERIORITY||Risk Ratio (RR)|1.16|||<|0.01|TWO_SIDED|95.0|1.05|1.28|||Regression, Poisson|||The 3 vaccine-recommended groups were compared with the 3 vaccine-offered groups using poisson regression.||1.28|1.05|<.01
70885119|NCT03925727|141256066|SUPERIORITY||Mean Difference (Net)|1.4||||0.5533|TWO_SIDED|95.0|-3.2|6.0|||ANCOVA|||||6|-3.2|0.5533
70885120|NCT03925727|141256067|SUPERIORITY||Mean Difference (Net)|-0.6||||0.0192|TWO_SIDED|95.0|-1.1|-0.1|||ANCOVA|||||-0.1|-1.1|0.0192
70885121|NCT00558103|141256068|SUPERIORITY_OR_OTHER||Percentage of participants|29.0|||||TWO_SIDED|90.0|17.2|43.3|||||The estimated value represents the percentage of participants with CR and PR.|||43.3|17.2|
70885122|NCT00558103|141256068|SUPERIORITY_OR_OTHER||Percentage of participants|45.0|||||TWO_SIDED|90.0|30.9|59.3|||||The estimated value represents the percentage of participants with CR and PR.|||59.3|30.9|
70885123|NCT00558103|141256068|SUPERIORITY_OR_OTHER||Percentage of participants|47.0|||<|0.001|TWO_SIDED|90.0|32.8|62.1||Comparision of participants receiving lapatanib 1500 mg + placebo to historical control of 10% response rate|t-test, 1 sided||The estimated value represents the percentage of participants receiving lapatanib 1500 mg + placebo with CR and PR.|||62.1|32.8|<0.001
70885124|NCT00558103|141256068|SUPERIORITY_OR_OTHER||Percentage of participants|31.0|||||TWO_SIDED|90.0|11.3|57.3|||||The estimated value represents the percentage of participants with CR and PR.|||57.3|11.3|
70885125|NCT00558103|141256068|SUPERIORITY_OR_OTHER||Percentage of participants|58.0|||<|0.001|TWO_SIDED|90.0|43.3|71.5||Comparision of participants receiving lapatanib 1000 mg + pazopanib 400 mg to 10% historical response rate|t-test, 1 sided||The estimated value represents the percentage of participants receiving lapatanib 1000 mg + pazopanib 400 mg with CR and PR.|||71.5|43.3|<0.001
70885126|NCT00558103|141256068|SUPERIORITY_OR_OTHER||Difference in percentage of participants|11.0||||0.485|TWO_SIDED|90.0|-8.3|29.7|||Fisher Exact||The estimated value represents the percent difference in the percentage of participants with CR and PR.|||29.7|-8.3|0.485
70885127|NCT00558103|141256068|SUPERIORITY_OR_OTHER||Difference in percentage of participants|27.0||||0.116|TWO_SIDED|90.0|2.3|52.0|||Fisher Exact||The estimated value represents the percent difference in the percentage of participants with CR and PR.|||52.0|2.3|0.116
70885128|NCT02215070|141256075|OTHER|||||||0.12|||||||Chi-squared|||||||0.12
70885129|NCT02215070|141256077|OTHER|||||||0.006|||||||Log Rank|||||||0.006
70885130|NCT02215070|141256078|OTHER|||||||0.002|||||||Log Rank|||||||0.002
70885131|NCT00293384|141256099|SUPERIORITY_OR_OTHER||proportion|0.57||||0.1|TWO_SIDED|||||85% statistical power|Simon optimal design|||Optimal Simon design for phase II study. p0=45% p1=65%.||||0.10
70885132|NCT00293384|141256100|SUPERIORITY_OR_OTHER||proportion|0.63||||||||||||||||||
70885133|NCT00293384|141256102|SUPERIORITY_OR_OTHER||proportion|0.06|||||TWO_SIDED|||||||||||||
70963555|NCT00578786|141431982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.8|STANDARD_DEVIATION|101.22|||TWO_SIDED|95.0|4.2|33.5|||||Applies to Ambrisentan 5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||33.5|4.2|
70885134|NCT00773175|141256103|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-67.5||||0.5064|TWO_SIDED|95.0|-221.2|86.2||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department plus hospital stay|Treatment difference: subcutaneous minus intravenous|||86.2|-221.2|0.5064
70885135|NCT00773175|141256103|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|24.0||||0.0325|TWO_SIDED|95.0|-54.6|102.7||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department stay only|Treatment difference: subcutaneous minus intravenous|||102.7|-54.6|0.0325
70885136|NCT00773175|141256104|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-174.7||||0.8915|TWO_SIDED|95.0|-340.3|-9.1||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department plus hospital stay|Treatment difference: subcutaneous minus intravenous|||-9.1|-340.3|0.8915
70885137|NCT00773175|141256104|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-58.6||||0.5469|TWO_SIDED|95.0|-137.5|20.3||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department stay only|Treatment difference: subcutaneous minus intravenous|||20.3|-137.5|0.5469
70885138|NCT00773175|141256106|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-67.0||||0.5035|TWO_SIDED|95.0|-220.6|86.7||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department plus hospital stay|Treatment difference: subcutaneous minus intravenous|||86.7|-220.6|0.5035
70885139|NCT00773175|141256106|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|24.6||||0.0314|TWO_SIDED|95.0|-54.0|103.2||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department stay only|Treatment difference: subcutaneous minus intravenous|||103.2|-54.0|0.0314
70885140|NCT00773175|141256110|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-30.1|||||TWO_SIDED|95.0|-69.5|9.4|||||Treatment difference: subcutaneous minus intravenous; Emergency department plus hospital stay|||9.4|-69.5|
70885141|NCT00773175|141256110|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-40.2|||||TWO_SIDED|95.0|-77.3|-3.1|||||Treatment difference: subcutaneous minus intravenous; Emergency department stay only|||-3.1|-77.3|
70885142|NCT00773175|141256111|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-30.1|||||TWO_SIDED|95.0|-69.5|9.4|||||Treatment difference: subcutaneous minus intravenous; Emergency department plus hospital stay|||9.4|-69.5|
70885143|NCT00773175|141256111|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-40.2|||||TWO_SIDED|95.0|-77.3|-3.1|||||Treatment difference: subcutaneous minus intravenous; Emergency department stay only|||-3.1|-77.3|
70885144|NCT00773175|141256113|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|2.9|||||TWO_SIDED|95.0|0.3|5.5|||||Treatment difference: subcutaneous minus intravenous; Emergency department plus hospital stay|||5.5|0.3|
70885145|NCT00773175|141256113|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|2.2|||||TWO_SIDED|95.0|-0.2|4.7|||||Treatment difference: subcutaneous minus intravenous; Emergency department stay only|||4.7|-0.2|
70885146|NCT00773175|141256114|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.8|1.9|||||Treatment difference: subcutaneous minus intravenous; Emergency department plus hospital stay|||1.9|-2.8|
70885147|NCT00773175|141256114|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-3.4|0.8|||||Treatment difference: subcutaneous minus intravenous; Emergency department stay only|||0.8|-3.4|
70885148|NCT00773175|141256125|SUPERIORITY||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|0.1|0.3|||||Treatment difference = SC minus IV|||0.3|0.1|
70885149|NCT00773175|141256126|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.0658|TWO_SIDED|95.0|-0.9|0.0|||ANOVA|From Analysis of Variance (ANOVA) model with center and treatment as factors.|Treatment difference = SC minus IV.|||0.0|-0.9|0.0658
70885150|NCT00773175|141256127|SUPERIORITY||Mean Difference (Net)|-1.0||||0.6208|TWO_SIDED|95.0|-4.8|2.9|||ANOVA|From ANOVA model with center and treatment as factors|Treatment difference = SC minus IV|||2.9|-4.8|0.6208
70885151|NCT00773175|141256129|SUPERIORITY|||||||0.0685||||||Cochran-Mantel-Haenszel (CMH) test controlling for center|Cochran-Mantel-Haenszel|Question 1||||||0.0685
70885152|NCT00773175|141256129|SUPERIORITY|||||||0.0004||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 2||||||0.0004
70885153|NCT00773175|141256129|SUPERIORITY|||||||0.6861||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 3||||||0.6861
70885154|NCT00773175|141256129|SUPERIORITY|||||||0.2323||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 4||||||0.2323
70885155|NCT00773175|141256130|SUPERIORITY|||||||0.0033||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Effectiveness||||||0.0033
70885156|NCT00773175|141256130|SUPERIORITY||||||<|0.0001||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Degree of difficulty||||||< 0.0001
70885157|NCT00773175|141256131|SUPERIORITY|||||||0.2012||||||CMH test controlling for Center|Cochran-Mantel-Haenszel|Question 1||||||0.2012
70885158|NCT00773175|141256131|SUPERIORITY||||||<|0.0001||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 2||||||< 0.0001
70885159|NCT00773175|141256131|SUPERIORITY|||||||0.1302||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 4||||||0.1302
70885160|NCT00773175|141256131|SUPERIORITY|||||||0.0852||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 5||||||0.0852
70885161|NCT00773175|141256131|SUPERIORITY|||||||0.0275||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 6||||||0.0275
70885162|NCT00773175|141256137|SUPERIORITY|||||||0.0247|||||||Wilcoxon (Mann-Whitney)|||||||0.0247
70885163|NCT00773175|141256138|SUPERIORITY|||||||0.0007||||||CMH test controlling for center|Cochran-Mantel-Haenszel|||||||0.0007
70885164|NCT04300296|141256250|OTHER||Posterior median difference|-13.9|||||TWO_SIDED|95.0|-44.8|19.3|||||Bayesian model to obtain the posterior distribution of the treatment difference between AIN457 and placebo|||19.3|-44.8|
70885165|NCT04300296|141256250|OTHER||Posterior median difference|14.1|||||TWO_SIDED|95.0|-17.0|40.7|||||Bayesian model to obtain the posterior distribution of the treatment difference between AIN457 and placebo|||40.7|-17.0|
70885166|NCT04300296|141256250|OTHER||Posterior median difference|6.5|||||TWO_SIDED|95.0|-25.4|35.4|||||Bayesian model to obtain the posterior distribution of the treatment difference between AIN457 and placebo|||35.4|-25.4|
70885167|NCT01633944|141256275|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.67||||0.0012|TWO_SIDED|95.0|-1.07|-0.26|||ANCOVA|||||-0.26|-1.07|0.0012
70885168|NCT01633944|141256276|SUPERIORITY_OR_OTHER|||||||0.0012|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by stratum (dose level)||Responders with ≥30% pain reduction||||0.0012
70885169|NCT01633944|141256276|SUPERIORITY_OR_OTHER|||||||0.0754|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by stratum (dose level)||Responders with ≥50% pain reduction||||0.0754
70885170|NCT00958776|141256291|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.973|TWO_SIDED|95.0|0.69|1.55|||Wilcoxon-Gehan statistic|Analysis stratified by duration of illness at randomization, ICU status and use of supplemental oxygen at Baseline, influenza season and type.|The hazard ratio was calculated using a Cox regression model with factors of duration of illness at randomization, ICU status at Baseline, use of supplemental oxygen at Baseline, influenza season, and influenza type.|||1.55|0.69|0.973
70885171|NCT00958776|141256293|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.558|TWO_SIDED|95.0|0.75|1.72|||Wilcoxon-Gehan statistic|Analysis stratified by duration of illness at randomization, ICU status and use of supplemental oxygen at Baseline, influenza season and type.|The hazard ratio was calculated using a Cox regression model with factors of duration of illness at randomization, ICU status at Baseline, use of supplemental oxygen at Baseline, influenza season, and influenza type.|||1.72|0.75|0.558
70885172|NCT00958776|141256294|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.633|TWO_SIDED|95.0|0.59|1.31|||Wilcoxon-Gehan statistic|Analysis stratified by duration of illness at randomization, ICU status and use of supplemental oxygen at Baseline, influenza season and type.|The hazard ratio was calculated using a Cox regression model with factors of duration of illness at randomization, ICU status at Baseline, use of supplemental oxygen at Baseline, influenza season, and influenza type.|||1.31|0.59|0.633
70885173|NCT00958776|141256295|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.46||||0.747|TWO_SIDED|95.0|0.92|2.32|||Wilcoxon-Gehan statistic|Analysis stratified by duration of illness at randomization, ICU status and use of supplemental oxygen at Baseline, influenza season and type.|The hazard ratio was calculated using a Cox regression model with factors of duration of illness at randomization, ICU status at Baseline, use of supplemental oxygen at Baseline, influenza season, and influenza type.|||2.32|0.92|0.747
70885174|NCT00958776|141256297|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.303|TWO_SIDED|95.0|0.41|2.98|||Wilcoxon-Gehan statistic|Analysis stratified by duration of illness at randomization, ICU status and use of supplemental oxygen at Baseline, influenza season and type.|The hazard ratio is calculated using a Cox regression model with factors of duration of illness at randomization, ICU status at baseline, use of supplemental oxygen at baseline, influenza season, and influenza type.|||2.98|0.41|0.303
70885175|NCT00958776|141256299|SUPERIORITY_OR_OTHER|||||||0.768|TWO_SIDED||||||Cochran-Mantel-Haenszel|Analysis stratified by symptom onset prior to randomization, Baseline ICU status, need for supplemental oxygen at Baseline, influenza season and type.||||||0.768
70885176|NCT00958776|141256300|SUPERIORITY_OR_OTHER|||||||0.758|TWO_SIDED||||||Cochran-Mantel-Haenszel|Analysis stratified by symptom onset prior to randomization, Baseline ICU status, need for supplemental oxygen at Baseline, influenza season and type.||||||0.758
70885177|NCT03762083|141256344|OTHER|The clinical performance endpoint - Clinical cure rate on Day 7 - was calculated and presented together with a one-sided 95% CI based on the exact binomial distribution (Clopper-Pearson).|Clinical cure rate|81.9|||||ONE_SIDED|95.0|63.1|||||||"It was assumed that the true cure rate was equal to 70%, therefore 22 patients were needed to obtain 90% chance (90% power) to show that the one-sided 95% confidence interval (CI) for the observed cure rate was above 40%.~Hypotheses for the primary clinical performance endpoint:~* Null hypothesis: Clinical cure rate is less than or equal to 40%.~* Alternative hypothesis (one-sided): Clinical cure rate is above 40%."|||63.1|
70885178|NCT03762083|141256345|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Prop. negative for Amsel criterion 1.|85.7|||||TWO_SIDED|95.0|63.7|97.0||||||||97.0|63.7|
70885179|NCT03762083|141256346|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Prop. negative for Amsel criterion 2.|90.0|||||TWO_SIDED|95.0|68.3|98.8||||||||98.8|68.3|
70885180|NCT03762083|141256347|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Prop. negative for Amsel criterion 3.|86.4|||||TWO_SIDED|95.0|65.1|97.1||||||||97.1|65.1|
70885181|NCT03762083|141256349|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Recurrence rate Day 14|5.6|||||TWO_SIDED|95.0|0.1|27.3||||||||27.3|0.1|
70885182|NCT03762083|141256349|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Recurrence rate Day 35|0.0|||||TWO_SIDED|95.0|0.0|20.6||||||||20.6|0|
70963556|NCT00578786|141431982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.8|STANDARD_DEVIATION|87.07|||TWO_SIDED|95.0|10.1|45.4|||||Applies to Ambrisentan 10 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||45.4|10.1|
70885183|NCT04889625|141256371|NON_INFERIORITY|This study was powered to demonstrate non-inferiority of the Test lens relative to the Control lens with respect to binocular HLHC distance, intermediate and near visual acuity. A non-inferiority margin of 0.05 logMAR was used; (0.05) logMAR is approximately half a line on an ETDRS chart.|least-square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.0085|||TWO_SIDED|95.0|-0.017|0.017|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as senofilcon A - delefilcon A|Distance (4m)||0.017|-0.017|
70885184|NCT04889625|141256371|NON_INFERIORITY|This study was powered to demonstrate non-inferiority of the Test lens relative to the Control lens with respect to binocular HLHC distance, intermediate and near visual acuity. A non-inferiority margin of 0.05 logMAR was used; (0.05) logMAR is approximately half a line on an ETDRS chart.|least-square mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.0108|||TWO_SIDED|95.0|-0.051|-0.008|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as senofilcon A - delefilcon A|Intermediate (64cm)||-0.008|-0.051|
70885185|NCT04889625|141256371|NON_INFERIORITY|This study was powered to demonstrate non-inferiority of the Test lens relative to the Control lens with respect to binocular HLHC distance, intermediate and near visual acuity. A non-inferiority margin of 0.05 logMAR was used; (0.05) logMAR is approximately half a line on an ETDRS chart.|least-square mean difference|-0.036|STANDARD_ERROR_OF_MEAN|0.0129|||TWO_SIDED|95.0|-0.062|-0.011|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as senofilcon A - delefilcon A|Near (40cm)||-0.011|-0.062|
70885186|NCT04889625|141256372|NON_INFERIORITY|This study was powered to demonstrate the primary hypotheses. However, the final sample size calculation was deemed large enough to test for Non-inferiority of the Test relative to the Control. A non-inferiority margin of -5 points was used.|least-square mean difference|6.3|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|95.0|2.0|10.5|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as senofilcon A (C3)- delefilcon A|||10.5|2.0|
70885187|NCT03746522|141256373|OTHER|||||||0.0006||||||P-value was one-sided and compared with alpha = 0.025.|Rubin's Rule|||||||0.0006
70885188|NCT03746522|141256374|OTHER|||||||0.0005||||||p-value was one-sided and compared with alpha = 0.025|Rubin's Rule|||||||0.0005
70885189|NCT03746522|141256375|OTHER||||||<|0.0001||||||p-value was one-sided and compared with alpha=0.025.|Rubin's Rule|||||||<0.0001
70885190|NCT03746522|141256376|OTHER||||||<|0.0001||||||p-value was one-sided and compared with alpha = 0.025.|Rubin's Rule|||||||<0.0001
70885191|NCT02439775|141256378|SUPERIORITY|||||||0.1194||||||p\<0.05 required for significance|ANCOVA|||||||0.1194
70885192|NCT02659020|141256394|SUPERIORITY||Hazard Ratio (HR)|0.945||||0.775|TWO_SIDED|95.0|0.639|1.397||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and Eastern Cooperative Oncology Group Performance Status (ECOG PS) (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||1.397|0.639|0.775
70885193|NCT02659020|141256404|SUPERIORITY||Hazard Ratio (HR)|0.667||||0.148|TWO_SIDED|95.0|0.385|1.158||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||1.158|0.385|0.148
70885194|NCT02659020|141256405|SUPERIORITY||Hazard Ratio (HR)|0.692||||0.055|TWO_SIDED|95.0|0.476|1.007||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||1.007|0.476|0.055
70885195|NCT02659020|141256405|SUPERIORITY||Hazard Ratio (HR)|0.828||||0.482|TWO_SIDED|95.0|0.49|1.398||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank|||||1.398|0.490|0.482
70885196|NCT02659020|141256406|SUPERIORITY||Odds Ratio (OR)|1.589||||0.1891|TWO_SIDED|95.0|0.794|3.179||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Exact Mantel-Haenszel test||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||3.179|0.794|0.1891
70885197|NCT02659020|141256406|SUPERIORITY||Odds Ratio (OR)|2.668||||0.0642|TWO_SIDED|95.0|0.923|7.71||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Exact Mantel-Haenszel test||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||7.710|0.923|0.0642
70885198|NCT02659020|141256407|SUPERIORITY||Odds Ratio (OR)|1.106||||0.7724|TWO_SIDED|95.0|0.558|2.194||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Exact Mantel-Haenszel test||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||2.194|0.558|0.7724
70885199|NCT02659020|141256407|SUPERIORITY||Odds Ratio (OR)|1.222||||0.6508|TWO_SIDED|95.0|0.513|2.911||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Exact Mantel-Haenszel test||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||2.911|0.513|0.6508
70963557|NCT00578786|141431982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.6|STANDARD_DEVIATION|96.54|||TWO_SIDED|95.0|6.8|26.4|||||Applies to Ambrisentan combined group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||26.4|6.8|
70885200|NCT02659020|141256408|SUPERIORITY||Hazard Ratio (HR)|0.661||||0.073|TWO_SIDED|95.0|0.419|1.041||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||1.041|0.419|0.073
70885201|NCT02659020|141256408|SUPERIORITY||Hazard Ratio (HR)|0.703||||0.225|TWO_SIDED|95.0|0.395|1.253||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||1.253|0.395|0.225
70885202|NCT02659020|141256409|SUPERIORITY||Hazard Ratio (HR)|1.213||||0.332|TWO_SIDED|95.0|0.834|1.764||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Fatigue||1.764|0.834|0.332
70885203|NCT02659020|141256409|SUPERIORITY||Hazard Ratio (HR)|0.813||||0.389|TWO_SIDED|95.0|0.514|1.287||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Nausea and vomiting||1.287|0.514|0.389
70885204|NCT02659020|141256409|SUPERIORITY||Hazard Ratio (HR)|0.598||||0.02|TWO_SIDED|95.0|0.386|0.926||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Pain||0.926|0.386|0.020
70885205|NCT02659020|141256409|SUPERIORITY||Hazard Ratio (HR)|0.947||||0.821|TWO_SIDED|95.0|0.622|1.442||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Dyspnoea||1.442|0.622|0.821
70885206|NCT02659020|141256409|SUPERIORITY||Hazard Ratio (HR)|0.931||||0.812|TWO_SIDED|95.0|0.574|1.509||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Insomnia||1.509|0.574|0.812
70885207|NCT02659020|141256409|SUPERIORITY||Hazard Ratio (HR)|1.355||||0.162|TWO_SIDED|95.0|0.893|2.055||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Appetite loss||2.055|0.893|0.162
70885208|NCT02659020|141256409|SUPERIORITY||Hazard Ratio (HR)|0.881||||0.619|TWO_SIDED|95.0|0.55|1.413||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Constipation||1.413|0.550|0.619
70885209|NCT02659020|141256409|SUPERIORITY||Hazard Ratio (HR)|1.134||||0.597|TWO_SIDED|95.0|0.746|1.724||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Diarrhoea||1.724|0.746|0.597
70885210|NCT02659020|141256409|SUPERIORITY||Hazard Ratio (HR)|0.766||||0.38|TWO_SIDED|95.0|0.425|1.381||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Financial difficulties||1.381|0.425|0.380
70885211|NCT02659020|141256409|SUPERIORITY||Hazard Ratio (HR)|1.046||||0.877|TWO_SIDED|95.0|0.635|1.723||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Fatigue||1.723|0.635|0.877
70885212|NCT02659020|141256409|SUPERIORITY||Hazard Ratio (HR)|1.102||||0.791|TWO_SIDED|95.0|0.568|2.139||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Nausea and vomiting||2.139|0.568|0.791
70885213|NCT02659020|141256409|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.487|TWO_SIDED|95.0|0.454|1.443||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Pain||1.443|0.454|0.487
70885214|NCT02659020|141256409|SUPERIORITY||Hazard Ratio (HR)|1.014||||0.976|TWO_SIDED|95.0|0.556|1.85||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Dyspnoea||1.850|0.556|0.976
70885215|NCT02659020|141256409|SUPERIORITY||Hazard Ratio (HR)|1.694||||0.111|TWO_SIDED|95.0|0.882|3.25||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Insomnia||3.250|0.882|0.111
70885216|NCT02659020|141256409|SUPERIORITY||Hazard Ratio (HR)|1.108||||0.76|TWO_SIDED|95.0|0.62|1.979||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Appetite loss||1.979|0.620|0.760
70885217|NCT02659020|141256409|SUPERIORITY||Hazard Ratio (HR)|1.119||||0.747|TWO_SIDED|95.0|0.586|2.135||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Constipation||2.135|0.586|0.747
70885218|NCT02659020|141256409|SUPERIORITY||Hazard Ratio (HR)|1.367||||0.33|TWO_SIDED|95.0|0.726|2.576||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Diarrhoea||2.576|0.726|0.330
70885219|NCT02659020|141256409|SUPERIORITY||Hazard Ratio (HR)|1.373||||0.411|TWO_SIDED|95.0|0.636|2.965||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Financial difficulties||2.965|0.636|0.411
70885220|NCT01120210|141256429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.0595|TWO_SIDED|90.0|-0.016|0.564|||ANCOVA|one-sided p-value and one-sided alpha=0.05||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in cardiac index (CI) at the end of the 5 ng/kg/min dose.||0.564|-0.016|0.0595
70885221|NCT01120210|141256429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.0215|TWO_SIDED|90.0|0.064|0.595||one-sided p-value and one-sided alpha=0.05|ANCOVA|||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in cardiac index (CI) at the end of the 15 ng/kg/min dose.||0.595|0.064|0.0215
70885222|NCT01120210|141256429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57||||0.0049|TWO_SIDED|90.0|0.214|0.921||one-sided p-value and one-sided alpha=0.05|ANCOVA|||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in cardiac index (CI) at the end of the 30 ng/kg/min dose.||0.921|0.214|0.0049
70885223|NCT01120210|141256430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.4729|TWO_SIDED|90.0|-2.312|2.131||one-sided p-value and one-sided alpha=0.05|ANCOVA|||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in pulmonary capillary wedge pressure (PCWP) at the end of the 5 ng/kg/min dose.||2.131|-2.312|0.4729
70885224|NCT01120210|141256430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35||||0.2123|TWO_SIDED|90.0|-4.164|1.464||one-sided p-value and one-sided alpha=0.05|ANCOVA|||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in pulmonary capillary wedge pressure (PCWP) at the end of the 15 ng/kg/min dose.||1.464|-4.164|0.2123
70885225|NCT01120210|141256430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.58||||0.0821|TWO_SIDED|90.0|-5.639|0.483||one-sided p-value and one-sided alpha=0.05|ANCOVA|||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in pulmonary capillary wedge pressure (PCWP) at the end of the 30 ng/kg/min dose.||0.483|-5.639|0.0821
70885226|NCT01120210|141256431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.7682|TWO_SIDED|95.0|-2.527|1.879||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in heart rate (HR) at the end of the 5 ng/kg/min dose.||1.879|-2.527|0.7682
70885227|NCT01120210|141256431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24||||0.4107|TWO_SIDED|95.0|-1.764|4.235||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in heart rate (HR) at the end of the 15 ng/kg/min dose.||4.235|-1.764|0.4107
70885228|NCT01120210|141256431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.16||||0.1811|TWO_SIDED|95.0|-1.046|5.372||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in heart rate (HR) at the end of the 30 ng/kg/min dose.||5.372|-1.046|0.1811
70885229|NCT01120210|141256432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67||||0.803|TWO_SIDED|95.0|-6.06|4.718||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in systolic blood pressure (SBP) at the end of the 5 ng/kg/min dose.||4.718|-6.060|0.8030
70885230|NCT01120210|141256432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99||||0.4923|TWO_SIDED|95.0|-7.781|3.801||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in systolic blood pressure (SBP) at the end of the 15 ng/kg/min dose.||3.801|-7.781|0.4923
70963558|NCT00578786|141431984|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08|STANDARD_DEVIATION|2.254|||TWO_SIDED|95.0|-0.55|0.38|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||0.38|-0.55|
70885231|NCT01120210|141256432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.77||||0.3152|TWO_SIDED|95.0|-11.251|3.708||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in systolic blood pressure (SBP) at the end of the 30 ng/kg/min dose.||3.708|-11.251|0.3152
70885232|NCT01120210|141256433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.36||||0.1561||95.0|-8.047|1.331||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in diastolic blood pressure (DBP) at the end of the 5 ng/kg/min dose.||1.331|-8.047|0.1561
70885233|NCT01120210|141256433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.55||||0.0282|TWO_SIDED|95.0|-10.482|-0.622||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in diastolic blood pressure (DBP) at the end of the 15 ng/kg/min dose.||-0.622|-10.482|0.0282
70885234|NCT01120210|141256433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.08||||0.0043|TWO_SIDED|95.0|-11.818|-2.332||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in diastolic blood pressure (DBP) at the end of the 30 ng/kg/min dose.||-2.332|-11.818|0.0043
70885235|NCT01120210|141256434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.9769|TWO_SIDED|95.0|-16.347|16.823||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in left ventricular end systolic volume (LVESV) at the end of the 30 ng/kg/min dose.||16.823|-16.347|0.9769
70885236|NCT01120210|141256435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.98||||0.8297|TWO_SIDED|95.0|-16.592|20.551||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in LVEDV at the end of the 30 ng/kg/min dose.||20.551|-16.592|0.8297
70885237|NCT01120210|141256436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.865|TWO_SIDED|95.0|-3.352|3.968||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in LVEF at the end of the 30 ng/kg/min dose.||3.968|-3.352|0.8650
70885238|NCT01120210|141256437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.95||||0.3748|TWO_SIDED|95.0|-1.204|3.102||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in FS at the end of the 30 ng/kg/min dose.||3.102|-1.204|0.3748
70885239|NCT01120210|141256438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.08||||0.2123|TWO_SIDED|95.0|-4.198|18.359||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SV at the end of the 5 ng/kg/min dose.||18.359|-4.198|0.2123
70885240|NCT01120210|141256438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.78||||0.1083|TWO_SIDED|95.0|-2.016|19.575||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SV at the end of the 15 ng/kg/min dose.||19.575|-2.016|0.1083
70885241|NCT01120210|141256438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.16||||0.018|TWO_SIDED|95.0|2.557|25.771||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SV at the end of the 30 ng/kg/min dose.||25.771|2.557|0.0180
70885242|NCT01120210|141256439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38||||0.4841|TWO_SIDED|95.0|-5.308|2.554||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in PASP at the end of the 5 ng/kg/min dose.||2.554|-5.308|0.4841
70885243|NCT01120210|141256439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||0.6665|TWO_SIDED|95.0|-5.567|3.594||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SV at the end of the 15 ng/kg/min dose.||3.594|-5.567|0.6665
70885244|NCT01120210|141256439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02||||0.6904|TWO_SIDED|95.0|-4.107|6.148||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in PASP at the end of the 30 ng/kg/min dose.||6.148|-4.107|0.6904
70885245|NCT01120210|141256440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.6304|TWO_SIDED|95.0|-2.197|3.588||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in PADP at the end of the 5 ng/kg/min dose.||3.588|-2.197|0.6304
70885246|NCT01120210|141256440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.842|TWO_SIDED|95.0|-3.851|3.153||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in PADP at the end of the 15 ng/kg/min dose.||3.153|-3.851|0.8420
70885247|NCT01120210|141256440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73||||0.6658|TWO_SIDED|95.0|-4.138|2.669||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in PADP at the end of the 30 ng/kg/min dose.||2.669|-4.138|0.6658
70885248|NCT01120210|141256441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-264.36||||0.051|TWO_SIDED|95.0|-529.875|1.147||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SVR at the end of the 5 ng/kg/min dose.||1.147|-529.875|0.0510
70885249|NCT01120210|141256441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-383.32||||0.0006|TWO_SIDED|95.0|-592.781|-173.867||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SVR at the end of the 15 ng/kg/min dose.||-173.867|-592.781|0.0006
70885250|NCT01120210|141256441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-527.77||||0.0001|TWO_SIDED|95.0|-764.07|-291.478||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SVR at the end of the 30 ng/kg/min dose.||-291.478|-764.070|0.0001
70963559|NCT00578786|141431984|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59|STANDARD_DEVIATION|2.45|||TWO_SIDED|95.0|-0.94|-0.23|||||Applies to Ambrisentan 5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||-0.23|-0.94|
70885251|NCT01494610|141256475|NON_INFERIORITY_OR_EQUIVALENCE|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. A two one-sided t-test procedure with α=0.05 for each one-sided test was used. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|1.508|||||TWO_SIDED|90.0|1.366|1.665|||||Data reflect Asthma + COPD participants. The ratio of adjusted geometric means is a comparision of treatment administered by the capsule-based inhaler and the MDPI.|||1.665|1.366|
70885252|NCT01494610|141256475|NON_INFERIORITY_OR_EQUIVALENCE|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|1.598|||||TWO_SIDED|90.0|1.369|1.864|||||Data reflect participants with asthma only. The ratio of adjusted geometric means is a comparision of treatment administered by the capsule-based inhaler and the MDPI.|||1.864|1.369|
70885253|NCT01494610|141256475|NON_INFERIORITY_OR_EQUIVALENCE|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. A two one-sided t-test procedure with α=0.05 for each one-sided test was used. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|1.421|||||TWO_SIDED|90.0|1.274|1.584|||||Data reflect participants with COPD only. The ratio of adjusted geometric means is the comparision of treatment administered by the capsule-based inhaler and the MDPI.|||1.584|1.274|
70885254|NCT01494610|141256476|NON_INFERIORITY_OR_EQUIVALENCE|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. A two one-sided t-test procedure with α=0.05 for each one-sided test was used. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|0.928|||||TWO_SIDED|90.0|0.886|0.971|||||Data reflect Asthma + COPD participants. The ratio of adjusted geometric means is the comparision of treatment administered by the capsule-based inhaler and the MDPI.|||0.971|0.886|
70885255|NCT01494610|141256476|NON_INFERIORITY_OR_EQUIVALENCE|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. A two one-sided t-test procedure with α=0.05 for each one-sided test was used. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|0.892|||||TWO_SIDED|90.0|0.848|0.939|||||Data reflect participants with asthma only. The ratio of adjusted geometric means is the comparision of treatment administered by the capsule-based inhaler and the MDPI.|||0.939|0.848|
70885256|NCT01494610|141256476|NON_INFERIORITY_OR_EQUIVALENCE|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. A two one-sided t-test procedure with α=0.05 for each one-sided test was used. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|0.966|||||TWO_SIDED|90.0|0.889|1.049|||||Data reflect participants with COPD only. The ratio of adjusted geometric means is the comparision of treatment administered by the capsule-based inhaler and the MDPI.|||1.049|0.889|
70885257|NCT00915798|141256525|SUPERIORITY_OR_OTHER||F|0.56||||0.46|TWO_SIDED||||||ANOVA|Threshold for statistical significance p \< 0.05||Frontal BOLD during abstinence in smokers and nonsmokers||||0.46
70885258|NCT00915798|141256525|SUPERIORITY_OR_OTHER||F|6.64||||0.012|TWO_SIDED||||||ANOVA|Threshold for statistical significance p \< 0.05|Diagnosis by smoking status interaction.|Parietal BOLD during abstinence in smokers and nonsmokers||||0.012
70885259|NCT00915798|141256525|SUPERIORITY_OR_OTHER||F|211.2||||0.04|TWO_SIDED||||||ANOVA|Threshold for statistical significance p \< 0.05|Main effect for smoking status.|Occipital BOLD during abstinence in smokers and nonsmokers.||||0.04
70885260|NCT00915798|141256525|SUPERIORITY_OR_OTHER||F|1.6||||0.22|TWO_SIDED||||||ANOVA|Threshold for statistical significance p \< 0.05||Frontal BOLD smoking versus nonsmoking in smokers with ADHD compared to control smokers.||||0.22
70885261|NCT00915798|141256525|SUPERIORITY_OR_OTHER||F|0.43||||0.51|TWO_SIDED||||||ANOVA|Threshold for statistical significance p \< 0.05||Parietal BOLD smoking versus nonsmoking in smokers with ADHD compared to control smokers.||||0.51
70885262|NCT00915798|141256525|SUPERIORITY_OR_OTHER||F|0.16||||0.69|TWO_SIDED||||||ANOVA|Threshold for statistical significance p \< 0.05||Occipital BOLD smoking versus nonsmoking in smokers with ADHD compared to control smokers.||||0.69
70885263|NCT02244580|141256539|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.423||||0.0018|TWO_SIDED|95.0|0.246|0.726|||Regression, Cox|||||0.726|0.246|0.0018
70885264|NCT02244580|141256540|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.42||||0.001|TWO_SIDED|95.0|0.25|0.71|||Regression, Cox|||||0.71|0.25|0.001
70885265|NCT02114879|141256591|SUPERIORITY|||||||0.007||||||The p-value refers to the time by group interaction. The a priori threshold for statistical significance in this planned primary test was p\<0.05.|Marginal Model|||This Primary analysis used a marginal model with time (baseline and discharge), condition (EMR vs SOC), and time x condition as fixed effects, with an unstructured covariance structure specified, based on Bayesian information criteria (BIC).||||0.007
70885266|NCT02114879|141256592|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
70885267|NCT02114879|141256593|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
70885268|NCT02114879|141256594|SUPERIORITY|||||||0.96||||||The p-value refers to the time by group interaction. The statistical significance in this test was p\<0.05.|Mixed Models Analysis|||This Primary analysis used a marginal model with time (baseline and discharge), condition (EMR vs SOC), and time x condition as fixed effects, with an unstructured covariance structure specified, based on Bayesian information criteria (BIC).||||0.96
70885269|NCT02114879|141256595|SUPERIORITY|||||||0.37||||||The p-value is calculated from a 2x2 Contingency Table consisting of rows that represent Discharged Home Vs Discharged to Institution and columns that represent the EMR and SOC groups.|Chi-squared|||||||0.37
70885270|NCT02114879|141256596|SUPERIORITY|||||||0.85||||||The p-value is calculated from a 2x2 Contingency Table consisting of rows that represent Yes/No Rehospitalization and columns that represent the EMR and SOC groups.|Chi-squared|||||||0.85
70885271|NCT01455012|141256597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-160.34|STANDARD_ERROR_OF_MEAN|26.46|<|0.0001|TWO_SIDED|95.0|-213.23|-107.45||The analysis of this primary efficacy variable was performed using a two-sided alpha level of 5 %.|ANCOVA||The treatment effect was estimated on the basis of the Least Square Mean (LSM) of the difference as well as on the 95 % Confidence Interval and the p-value for that difference. Difference to Placebo was calculated as Rotigotine-Placebo.|The 95 % Confidence Interval (CI) and the p-value for the mean difference between Rotigotine and Placebo was obtained from a linear Analysis of Covariance (ANCOVA) model with fixed effects for treatment and Baseline antihypertensive use and a covariate for the Baseline number of nocturnal elevations of Systolic Blood Pressure that are associated with Periodic Limb Movements (PLMs).||-107.45|-213.23|<0.0001
70885272|NCT00613509|141256617|SUPERIORITY_OR_OTHER|||||||0.9406|TWO_SIDED|95.0|||||Log Rank|||||||0.9406
70885273|NCT00613509|141256617|SUPERIORITY_OR_OTHER|||||||0.9179|TWO_SIDED|95.0|||||Likelihood ratio test|||||||0.9179
70885274|NCT01686646|141256628|SUPERIORITY_OR_OTHER||LS Mean DIfference|3.5||||0.0248|TWO_SIDED|95.0|0.4|6.5||A hierarchical testing procedure was used such that p-values were only presented if the preceding treatment comparison was statistically significant (p\<0.05).|ANCOVA|From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.|A positive difference favored the first named treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.||6.5|0.4|0.0248
70885275|NCT01686646|141256628|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.1513|TWO_SIDED|95.0|-0.6|4.1||A hierarchical testing procedure was used such that p-values were only presented if the preceding treatment comparison was statistically significant (p\<0.05).|ANCOVA|From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.|A positive difference favoured the first named treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.||4.1|-0.6|0.1513
70885276|NCT01686646|141256628|SUPERIORITY_OR_OTHER||LS Mean Difference|3.9|||||TWO_SIDED|95.0|1.1|6.6||Not significant based on hierarchical testing.|ANCOVA|From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.|A positive difference favoured the first named treatment.|Null hypothesis was no difference in treatments in change from baseline in number of valid responses from RVIP task.||6.6|1.1|
70885277|NCT01686646|141256629|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9||||0.0696|TWO_SIDED|95.0|-0.2|6.1||A hierarchical testing procedure was used such that p-values were only presented if the preceding treatment comparison was statistically significant (p\<0.05).|ANCOVA|From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.|A positive difference favored the first named treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of accurate responses from the RVIP.||6.1|-0.2|0.0696
70885278|NCT01686646|141256629|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7|||||TWO_SIDED|95.0|0.3|5.2||A hierarchical testing procedure was used such that p-values were only presented if the preceding treatment comparison was statistically significant (p\<0.05).|ANCOVA|From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.|A positive difference favored the first named treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.||5.2|0.3|
70885279|NCT01686646|141256629|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|||||TWO_SIDED|95.0|-1.7|3.9||A hierarchical testing procedure was used such that p-values were only presented if the preceding treatment comparison was statistically significant (p\<0.05).|ANCOVA|From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.|A positive difference favored the first named treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.||3.9|-1.7|
70885280|NCT00556842|141256644|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|-6.37|||||TWO_SIDED|99.0|-9.18|-3.56||||||Using a multi-level model, the effect of THA versus HA on function (WOMAC) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for WOMAC total at 24 months.||-3.56|-9.18|
70885281|NCT00556842|141256644|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|-0.93|||||TWO_SIDED|99.0|-1.42|-0.44||||||Using a multi-level model, the effect of THA versus HA on function (WOMAC) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for WOMAC pain at 24 months.||-0.44|-1.42|
70885282|NCT00556842|141256644|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|-0.44|||||TWO_SIDED|99.0|-0.65|-0.23||||||Using a multi-level model, the effect of THA versus HA on function (WOMAC) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for WOMAC stiffness at 24 months.||-0.23|-0.65|
70885283|NCT00556842|141256644|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|-4.97|||||TWO_SIDED|99.0|-7.11|-2.83||||||Using a multi-level model, the effect of THA versus HA on function (WOMAC) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for WOMAC function at 24 months.||-2.83|-7.11|
70885284|NCT00556842|141256645|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Odds Ratio (OR)|0.72|||||TWO_SIDED|99.0|0.38|1.36||||||Using a multi-level model, the effect of THA versus HA on mobility (TUG) was estimated. We analyzed the TUG as a dichotomous outcome with the following categories: a) patients who complete the test in ≤12 seconds, and b) those who require \>12 seconds to complete the test or were unable to complete the test. We selected 12 seconds as the cut-off because this was the threshold used by the Centers for Disease Control and Prevention. The TUG was summarized using odds ratios and 99% CIs.||1.36|0.38|
70885285|NCT00556842|141256646|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|1.41|||||TWO_SIDED|99.0|-0.33|3.14||||||Using a multi-level model, the effect of THA versus HA on quality of life (SF-12) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for SF-12 PCS at 24 months.||3.14|-0.33|
70885286|NCT00556842|141256646|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|1.34|||||TWO_SIDED|99.0|-0.38|3.05||||||Using a multi-level model, the effect of THA versus HA on quality of life (SF-12) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for SF-12 MCS at 24 months.||3.05|-0.38|
70885287|NCT00556842|141256647|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|0.04|||||TWO_SIDED|99.0|-0.03|0.11||||||Using a multi-level model, the effect of THA versus HA on quality of life (EQ-5D) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for EQ-5D utility index at 24 months.||0.11|-0.03|
70885288|NCT00556842|141256647|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|0.72|||||TWO_SIDED|99.0|-2.02|3.46||||||Using a multi-level model, the effect of THA versus HA on quality of life (EQ-5D) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for EQ-5D VAS at 24 months.||3.46|-2.02|
70885289|NCT03400033|141256649|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95 percent (%) confidence interval (CI) for the treatment difference is greater than the pre-specified non-inferiority margin of -0.75 g/dL.|Least square (LS) mean difference|-0.05|||||TWO_SIDED|95.0|-0.21|0.1||||||||0.10|-0.21|
70885290|NCT03400033|141256650|SUPERIORITY||LS mean difference|-8.12||||0.3354|TWO_SIDED|95.0|-45.66|29.41|||ANCOVA|||||29.41|-45.66|0.3354
70885291|NCT03400033|141256651|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference is greater than the pre-specified non-inferiority margin of -0.75 g/dL.|LS mean difference|-0.14|||||TWO_SIDED|95.0|-0.37|0.1||||||||0.10|-0.37|
70885292|NCT03400033|141256652|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was above the non-inferiority margin of - 15%.|Median Difference (Final Values)|11.18||||0.0034|TWO_SIDED|95.0|2.83|19.56|||Van Elteren's test||Hodges-Lehmann Estimate of Treatment Difference has been reported.|||19.56|2.83|0.0034
70885293|NCT03400033|141256653|OTHER||Difference in response rate|0.1645||||0.0007|TWO_SIDED|95.0|0.06|0.27|||Cochran-Mantel-Haenszel|||||0.27|0.06|0.0007
70885294|NCT03400033|141256654|OTHER||Hazard Ratio (HR)|1.06||||0.5308|TWO_SIDED|95.0|0.26|4.22|||Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model adjusted for treatment group and region.|||4.22|0.26|0.5308
70885295|NCT03400033|141256655|SUPERIORITY||LS mean difference|-3.73||||0.083|TWO_SIDED|95.0|-9.03|1.56|||MMRM||SBP|||1.56|-9.03|0.083
70885296|NCT03400033|141256655|SUPERIORITY||LS mean difference|-2.23||||0.057|TWO_SIDED|95.0|-4.99|0.54|||MMRM||DBP|||0.54|-4.99|0.057
70885297|NCT03400033|141256655|SUPERIORITY||LS mean difference|-2.6||||0.059|TWO_SIDED|95.0|-5.86|0.67|||MMRM||MAP|||0.67|-5.86|0.059
70885298|NCT03400033|141256656|SUPERIORITY||Mean Difference (Net)|-0.5||||0.407|TWO_SIDED|95.0|-4.73|3.72|||ANCOVA||SBP|||3.72|-4.73|0.407
70885299|NCT03400033|141256656|SUPERIORITY||Mean Difference (Net)|-1.05||||0.179|TWO_SIDED|95.0|-3.29|1.19|||ANCOVA||DBP|||1.19|-3.29|0.179
70885300|NCT03400033|141256656|SUPERIORITY||Mean Difference (Net)|-0.86||||0.261|TWO_SIDED|95.0|-3.5|1.78|||ANCOVA||MAP|||1.78|-3.50|0.261
70885301|NCT03400033|141256657|OTHER||Ratio of exacerbation rate|0.7||||0.0093|TWO_SIDED|95.0|0.52|0.94|||Negative binomial model|||||0.94|0.52|0.0093
70885302|NCT03400033|141256659|SUPERIORITY||LS mean difference|-0.15||||0.0323|TWO_SIDED|95.0|-0.32|0.01|||MMRM||Week 8|||0.01|-0.32|0.0323
70885303|NCT03400033|141256659|SUPERIORITY||LS mean difference|-0.12||||0.0921|TWO_SIDED|95.0|-0.29|0.06|||MMRM||Week 12|||0.06|-0.29|0.0921
70885304|NCT03400033|141256659|SUPERIORITY||LS mean difference|-0.11||||0.1291|TWO_SIDED|95.0|-0.29|0.08|||MMRM||Week 28|||0.08|-0.29|0.1291
70885305|NCT03400033|141256659|SUPERIORITY||LS mean difference|-0.15||||0.0859|TWO_SIDED|95.0|-0.36|0.06|||MMRM||Week 52|||0.06|-0.36|0.0859
70885306|NCT03993938|141256667|OTHER|Delta PVI percentage change and Delta LAP (v-wave) percentage change were correlated using Spearman's rank correlation - two-tailed.|Spearman's rank correlation|0.34||||0.066|TWO_SIDED||||||Spearman's rank correlation|||||||0.066
70885307|NCT02434770|141256672|EQUIVALENCE|Primary efficacy objective 1 of this study was to demonstrate the equivalence of two lots of BBIBP bOPV in terms of post-vaccination anti-polio neutralizing antibody GMTs. The immune response of the two lots of BBIBP bOPV would be declared equivalent if the 95% confidence interval (CI) for the serotype-specific GMT ratio for both serotypes was contained within (0.5, 2.0).|Ratio of Geometric Mean Titers|0.84|||||TWO_SIDED|95.0|0.65|1.08|||||Lot 1 / Lot 2|||1.08|0.65|
70885308|NCT02434770|141256672|NON_INFERIORITY|Secondary efficacy objective 2 of this study was to demonstrate the non-inferiority of the two lots of BBIBP bOPV combined to the WHO control in terms of post-vaccination anti-polio neutralizing antibody GMTs. The two Lots combined would be declared non-inferior to the WHO control if the lower limit of the 95% CI for the serotype-specific GMT ratio of BBIBP Lots 1+2 over WHO control for both serotypes was \> 0.5.|Ratio of Geometric Mean Titers|1.08|||||TWO_SIDED|95.0|0.87|1.34|||||Lot 1 + Lot 2 / BioFarma bOPV|||1.34|0.87|
70885309|NCT02434770|141256673|EQUIVALENCE|Primary efficacy objective 1 of this study was to demonstrate the equivalence of two lots of BBIBP bOPV in terms of post-vaccination anti-polio neutralizing antibody GMTs. The immune response of the two lots of BBIBP bOPV would be declared equivalent if the 95% confidence interval (CI) for the serotype-specific GMT ratio for both serotypes was contained within (0.5, 2.0).|Ratio of Geometric Mean Titers|0.92|||||TWO_SIDED|95.0|0.73|1.15|||||Lot 1 / Lot 2|||1.15|0.73|
70885310|NCT02434770|141256673|NON_INFERIORITY|Secondary efficacy objective 2 of this study was to demonstrate the non-inferiority of the two lots of BBIBP bOPV combined to the WHO control in terms of post-vaccination anti-polio neutralizing antibody GMTs. The two Lots combined would be declared non-inferior to the WHO control if the lower limit of the 95% CI for the serotype-specific GMT ratio of BBIBP Lots 1+2 over WHO control for both serotypes was \> 0.5.|Ratio of Geometric Mean Titers|1.47|||||TWO_SIDED|95.0|1.21|1.79|||||BBIBP bOPV Lot 1 + Lot 2 / BioFarma bOPV|||1.79|1.21|
70963560|NCT00578786|141431984|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_DEVIATION|2.4|||TWO_SIDED|95.0|-1.0|-0.03|||||Applies to Ambrisentan 10 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||-0.03|-1.00|
70963561|NCT00578786|141431984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_DEVIATION|2.393|||TWO_SIDED|95.0|-0.69|-0.2|||||Applies to Ambrisentan combined group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||-0.20|-0.69|
70885311|NCT02434770|141256674|NON_INFERIORITY|Primary efficacy objective 2 of this study was to demonstrate the non-inferiority of the two lots of BBIBP bOPV combined to the WHO control in terms of post-vaccination anti-polio neutralizing antibody seroconversion rates. The immune response of the combined lots of BBIBP bOPV would be declared non-inferior to the WHO control if the lower limit of the 95% CI for the difference in percent responders is greater than negative 10, provided the two lots are declared equivalent.|Difference in seroconversion rate|1.5|||||TWO_SIDED|95.0|-0.5|4.6|||||BBIBP bOPV (Lot 1 + Lot 2) - BioFarma bOPV|For serotype 1||4.6|-0.5|
70885312|NCT02434770|141256674|NON_INFERIORITY|Primary efficacy objective 2 of this study was to demonstrate the non-inferiority of the two lots of BBIBP bOPV combined to the WHO control in terms of post-vaccination anti-polio neutralizing antibody seroconversion rates. The immune response of the combined lots of BBIBP bOPV would be declared non-inferior to the WHO control if the lower limit of the 95% CI for the difference in percent responders is greater than negative 10, provided the two lots are declared equivalent.|Difference in seroconversion rate|2.2|||||TWO_SIDED|95.0|-0.1|5.6|||||BBIBP bOPV (Lot 1 + Lot 2) - BioFarma bOPV|For Serotype 3||5.6|-0.1|
70885313|NCT02434770|141256674|OTHER|Secondary efficacy objective 1 of this study was to show consistency of the two lots in terms of post-vaccination anti-polio neutralizing antibody seroconversion rates. The two lots would be declared consistent if the upper and lower limits of the 95% CI for the difference in seroconversion rates is within 10 percentage points of the observed difference for both serotypes.|Difference in seroconversion rate|-0.4|||||TWO_SIDED|95.0|-3.0|2.1|||||Lot 1 - Lot 2|For Serotype 1||2.1|-3.0|
70885314|NCT02434770|141256674|NON_INFERIORITY|Secondary efficacy objective 1 of this study was to show consistency of the two lots in terms of post-vaccination anti-polio neutralizing antibody seroconversion rates. The two lots would be declared consistent if the upper and lower limits of the 95% CI for the difference in seroconversion rates is within 10 percentage points of the observed difference for both serotypes.|Difference in seroconversion rate|0.1|||||TWO_SIDED|95.0|-2.6|2.8|||||Lot 1 - Lot 2|For Serotype 3||2.8|-2.6|
70885315|NCT02434770|141256675|NON_INFERIORITY|To show non-inferiority of Lots 1+2 combined versus BioFarma bOPV Control, the lower limit of the 95% CI must be \> 0.5.|Ratio of Geometric Mean Titers|1.2|||||TWO_SIDED|95.0|0.89|1.63|||||Lot 1 + Lot 2 / BioFarma bOPV|||1.63|0.89|
70885316|NCT02434770|141256676|OTHER||Difference in seroprotection rate|-0.09||||0.5586|TWO_SIDED|95.0|-3.86|4.48|||Fisher's exact 1-tailed test|Fisher's exact 1-tailed test of a lower rate in Lots 1+2|BBIBP bOPV (Lot 1 + Lot 2) - BioFarma bOPV|||4.48|-3.86|0.5586
70885317|NCT02434770|141256677|NON_INFERIORITY|To show non-inferiority of Lots 1+2 combined versus BioFarma bOPV Control, the lower limit of the 95% CI must be \> 0.5.|Ratio of Geometric Mean Titers|0.99|||||TWO_SIDED|95.0|0.71|1.38|||||Lot 1 + Lot 2 / BioFarma bOPV|||1.38|0.71|
70885318|NCT00245765|141256693|SUPERIORITY||Odds Ratio (OR)|40.2|||<|0.001|TWO_SIDED|95.0|13.7|150.3|||Regression, Logistic|Logistic regression with treatment and baseline severity of psoriasis as factors.|Confidence limits are based on likelihood ratio statistics.|||150.3|13.7|<0.001
70885319|NCT00245765|141256693|SUPERIORITY||Odds Ratio (OR)|73.4|||<|0.001|TWO_SIDED|95.0|23.5|292.6|||Regression, Logistic|Logistic regression with treatment and baseline severity of psoriasis as factors.|Confidence limits are based on likelihood ratio statistics.|||292.6|23.5|<0.001
70885320|NCT00245765|141256694|SUPERIORITY||Odds Ratio (OR)|64.1|||<|0.001|TWO_SIDED|95.0|12.7|1169.1|||Regression, Logistic|Logistic regression with treatment and baseline severity of psoriasis as factors. Confidence limits are based on likelihood ratio statistics.||||1169.1|12.7|<0.001
70885321|NCT00245765|141256694|SUPERIORITY||Odds Ratio (OR)|162.6|||<|0.001|TWO_SIDED|95.0|31.4|2999.2|||Regression, Logistic|Logistic regression with treatment and baseline severity of psoriasis as factors.|Confidence limits are based on likelihood ratio statistics.|||2999.2|31.4|<0.001
70885322|NCT01966926|141256712|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power not calculated due to small sample size and pilot study intent.|chi square|2.05||||0.15|TWO_SIDED|||||P-value was unadjusted, with an a priori threshold for statistical significance set at p \<.05.|Chi-squared|1 degree of freedom||||||.15
70885323|NCT01966926|141256713|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power not calculated due to small sample size and pilot study intent.|Wilks' Lambda|0.96||||0.61||||||P-value not adjusted for multiple comparisons; a priori threshold of \<0.05 for statistical significance|MANOVA|Degrees of freedom: 2,27||Repeated measures analysis from baseline to six months.||||0.61
70885324|NCT01966926|141256714|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power not calculated due to small sample size and pilot study intent.|Wilks' Lambda|0.95||||0.5||||||P-value is unadjusted; a priori threshold for statistical significance was \<0.05.|MANOVA|Degrees of freedom: 2,27||Repeated measures analysis from baseline to six months.||||0.50
70885325|NCT01966926|141256715|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power not calculated due to small sample size and pilot study intent.|Wilks' Lambda|0.87||||0.15||||||P-value not adjusted for multiple comparisons; a priori threshold for statistical significance was \<0.05.|MANOVA|Degrees of freedom: 2,27||Repeated measures analysis from baseline to six months.||||0.15
70885326|NCT01966926|141256716|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power not calculated due to small sample size and pilot study intent.|Wilks' Lambda|0.91||||0.3||||||P-value not adjusted for multiple comparisons; a priori threshold for statistical significance was \<0.05.|MANOVA|Degrees of freedom: 2,26||Repeated measures analysis from baseline to six months.||||0.30
70885327|NCT01966926|141256717|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power not calculated due to small sample size and pilot study intent.|Wilks' Lambda|0.93||||0.17||||||P-value not adjusted for multiple comparisons; a priori threshold for statistical significance was \<0.05.|MANOVA|Degrees of freedom: 1,28||Repeated measures analysis from three to six months.||||0.17
70885328|NCT04074317|141256718|EQUIVALENCE|Treatment groups were compared using an analysis of variance (ANOVA) model, including sequence, period, and treatment as fixed effects and patient within sequence as random effect.|||||<|0.0001||||||Least-squares geometric means for ln-transformed data.|ANOVA|||||||<0.0001
70885329|NCT04074317|141256718|EQUIVALENCE|Treatment groups were compared using an analysis of variance (ANOVA) model, including sequence, period, and treatment as fixed effects and patient within sequence as random effect.||||||0.694|||||||ANOVA|||||||0.694
70885330|NCT04074317|141256718|EQUIVALENCE|Treatment groups were compared using an analysis of variance (ANOVA) model, including sequence, period, and treatment as fixed effects and patient within sequence as random effect.|||||<|0.0001|||||||ANOVA|||||||<0.0001
70885331|NCT04074317|141256719|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups.|LS Mean Difference|-21.29||||0.041|TWO_SIDED|95.0|-41.23|-1.36|||ANOVA|||Plasma Glucose Levels: \>180 mg/dL: 0 to 90 minutes||-1.36|-41.23|0.041
70885332|NCT04074317|141256719|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups.|LS Mean Difference|-7.45||||0.453|TWO_SIDED|95.0|-31.43|16.54|||ANOVA|||Plasma Glucose Levels: \>180 mg/dL: 0 to 90 minutes||16.54|-31.43|0.453
70885333|NCT04074317|141256719|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|13.85||||0.161|TWO_SIDED|95.0|-8.46|36.15|||ANOVA|||Plasma Glucose Levels: \>180 mg/dL: 0 to 90 minutes||36.15|-8.46|0.161
70885334|NCT04074317|141256719|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|-23.93|||<|0.001|TWO_SIDED|95.0|-35.37|-12.48|||ANOVA|||Plasma Glucose \>180 mg/dL: 0 to 180 minutes||-12.48|-35.37|<0.001
70885335|NCT04074317|141256719|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|3.1||||0.564|TWO_SIDED|95.0|-7.8|14.0|||ANOVA|||Plasma Glucose \>180 mg/dL: 0 to 180 minutes||14.00|-7.80|0.564
70885336|NCT04074317|141256719|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|27.03|||<|0.001|TWO_SIDED|95.0|15.96|38.09|||ANOVA|||Plasma Glucose \>180 mg/dL: 0 to 180 minutes||38.09|15.96|<0.001
70885337|NCT04074317|141256719|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|-1.74||||0.813|TWO_SIDED|95.0|-16.7|13.22|||ANOVA|||Plasma Glucose \>180 mg/dL: 0 to 360 minutes||13.22|-16.70|0.813
70885338|NCT04074317|141256719|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|2.35||||0.73|TWO_SIDED|95.0|-11.47|16.17|||ANOVA|||Plasma Glucose \>180 mg/dL: 0 to 360 minutes||16.17|-11.47|0.730
70885339|NCT04074317|141256719|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|4.09||||0.582|TWO_SIDED|95.0|-10.97|19.15|||ANOVA|||Plasma Glucose \>180 mg/dL: 0 to 360 minutes||19.15|-10.97|0.582
70885340|NCT04074317|141256725|EQUIVALENCE|"Bioequivalence would require 90% confidence intervals of the geometric mean ratio to be contained within the 80-125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|37.04|||<|0.0001|TWO_SIDED|90.0|31.36|43.75||Results of the statistical evaluation of ANOVA (alpha=0.05) for the hypothesis of equal treatment effects.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||43.75|31.36|<0.0001
70885341|NCT04074317|141256726|OTHER||Ratio of least-square means|435.96|||<|0.0001|TWO_SIDED|||||Results of the statistical evaluation of ANOVA (alpha = 0.05) for the hypothesis of equal treatment effects.|ANOVA||Ratio calculated as PRAM least-squares mean divided by the Regular Insulin + Pramlintide least-squares mean, expressed as a percentage.|The statistical model was an analysis of variance (ANOVA) with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||||<0.0001
70885342|NCT04074317|141256727|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|60.44||||0.0075|TWO_SIDED|90.0|45.41|80.43||Results of the statistical evaluation of ANOVA (alpha=0.05) for the hypothesis of equal treatment effects.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 90 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||80.43|45.41|0.0075
70885343|NCT04074317|141256727|EQUIVALENCE|"Bioequivalence would require 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|93.32||||0.6773|TWO_SIDED|90.0|70.14|124.16||Results of the statistical evaluation of ANOVA (alpha=0.05) for the hypothesis of equal treatment effects.|ANOVA|Based on Least-Squares geometric means for ln-transformed data.|"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 180 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||124.16|70.14|0.6773
70885344|NCT04074317|141256727|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|97.43||||0.8768|TWO_SIDED|90.0|72.94|130.14||Results of the statistical evaluation of ANOVA (alpha=0.05) for the hypothesis of equal treatment effects.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 360 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||130.14|72.94|0.8768
70885345|NCT04074317|141256728|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|53.83|||<|0.0001|TWO_SIDED|90.0|44.51|65.11||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|The statistical model was ana analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||65.11|44.51|<0.0001
70885346|NCT04074317|141256728|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|73.16||||0.0192|TWO_SIDED|90.0|61.06|87.67||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||87.67|61.06|0.0192
70885347|NCT04074317|141256728|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|135.91||||0.0244|TWO_SIDED|90.0|113.1|163.31||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as Regular Insulin geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||163.31|113.10|0.0244
70885348|NCT04074317|141256729|OTHER||Ratio of least-square means|73.53||||0.2541|TWO_SIDED|||||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05|ANOVA||Ratio calculated as PRAM least-squares mean divided by the Regular Insulin least-squares mean, expressed as a percentage.|The statistical model was an analysis of variance (ANOVA) with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||||0.2541
70885349|NCT04074317|141256729|OTHER||Ratio of least-squares means|103.89|||>|0.9999|TWO_SIDED|||||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||Ratio calculated as PRAM least-squares mean divided by the Regular Insulin + Pramlintide least-squares mean, expressed as a percentage.|The statistical model was an analysis of variance (ANOVA) with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||||>0.9999
70885350|NCT04074317|141256729|OTHER||Ratio of least-square means|141.29||||0.1747|TWO_SIDED|||||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||Ratio calculated as Regular Insulin least-squares mean divided by the Regular Insulin + Pramlintide least-squares mean, expressed as a percentage.|The statistical model was an analysis of variance (ANOVA) with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||||0.1747
70885351|NCT04074317|141256730|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|53.16|||<|0.0001|TWO_SIDED|90.0|43.59|64.83||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 90 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||64.83|43.59|<0.0001
70885352|NCT04074317|141256730|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|65.24||||0.0018|TWO_SIDED|90.0|54.02|78.8||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 90 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||78.80|54.02|0.0018
70885353|NCT04074317|141256730|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|122.73||||0.2391|TWO_SIDED|90.0|101.33|148.66||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05|ANOVA||"Ratio calculated as Regular Insulin geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 90 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||148.66|101.33|0.2391
70885354|NCT04074317|141256730|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|54.2|||<|0.0001|TWO_SIDED|90.0|47.58|61.73||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 180 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||61.73|47.58|<0.0001
70963562|NCT00578786|141431985|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23|STANDARD_DEVIATION|2.603|||TWO_SIDED|95.0|-0.31|0.76|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||0.76|-0.31|
70963563|NCT00578786|141431985|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.33|STANDARD_DEVIATION|2.477|||TWO_SIDED|95.0|-0.68|0.03|||||Applies to Ambrisentan 5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||0.03|-0.68|
70963564|NCT00578786|141431985|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.65|STANDARD_DEVIATION|2.305|||TWO_SIDED|95.0|-1.12|-0.18|||||Applies to Ambrisentan 10 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||-0.18|-1.12|
70885355|NCT04074317|141256730|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|71.29||||0.0002|TWO_SIDED|90.0|62.99|80.69||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 180 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||80.69|62.99|0.0002
70885356|NCT04074317|141256730|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|131.55||||0.0026|TWO_SIDED|90.0|116.01|149.17||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as Regular Insulin geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 180 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||149.17|116.01|0.0026
70885357|NCT04074317|141256730|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|51.34|||<|0.0001|TWO_SIDED|90.0|46.74|56.39||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 360 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||56.39|46.74|<0.0001
70885358|NCT04074317|141256730|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|78.24||||0.0003|TWO_SIDED|90.0|71.39|85.76||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 360 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||85.76|71.39|0.0003
70885359|NCT04074317|141256730|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|152.41|||<|0.0001|TWO_SIDED|90.0|138.91|167.22||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as Regular Insulin geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 360 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||167.22|138.91|<0.0001
70885360|NCT00653224|141256736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|||<|0.001||95.0|-1.33|-0.45||If the p-value of this estimated difference is lower than 5% the mean T5SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the mean of T5SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis for the primary endpoint is expressed as follows: 'The mean 24-hr reflective T5SS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.45|-1.33|<0.001
70885361|NCT00653224|141256737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.001||95.0|-0.52|-0.17||If the p-value of this estimated difference is lower than 5% the mean change from baseline in overall RQLQ score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in overall RQLQ score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in overall RQLQ score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.17|-0.52|<0.001
70885362|NCT00653224|141256738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|||<|0.001||95.0|-0.47|-0.15||If the p-value of this estimated difference is lower than 5% the mean change from baseline in overall RQLQ score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in overall RQLQ score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in overall RQLQ score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.15|-0.47|<0.001
70885363|NCT00653224|141256739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.001||95.0|-0.52|-0.17||If the p-value of this estimated difference is lower than 5% the mean change from baseline in overall RQLQ score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in overall RQLQ score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in overall RQLQ score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.17|-0.52|<0.001
70963565|NCT00578786|141431985|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27|STANDARD_DEVIATION|2.48|||TWO_SIDED|95.0|-0.52|-0.02|||||Applies to Ambrisentan combined group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||-0.02|-0.52|
70885364|NCT00653224|141256740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.042||95.0|-0.49|-0.01||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ activities score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ activities score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ activities score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.01|-0.49|0.042
70885365|NCT00653224|141256741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.014||95.0|-0.52|-0.06||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ activities score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ activities score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ activities score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.06|-0.52|0.014
70885366|NCT00653224|141256742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.036||95.0|-0.51|-0.02||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ activities score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ activities score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ activities score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.02|-0.51|0.036
70885367|NCT00653224|141256743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.01||95.0|-0.48|-0.07||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ sleep score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ sleep score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ sleep score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.07|-0.48|0.010
70885368|NCT00653224|141256744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.026||95.0|-0.43|-0.03||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ sleep score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ sleep score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ sleep score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.03|-0.43|0.026
70885369|NCT00653224|141256745|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.25||||0.018||95.0|-0.45|-0.04||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ sleep score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ sleep score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ sleep score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.04|-0.45|0.018
70885370|NCT00653224|141256746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.002||95.0|-0.47|-0.1||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ non-nose/eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ N-N/E symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as: 'The mean change from baseline in RQLQ non-nose/eye symptoms score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.10|-0.47|0.002
70885371|NCT00653224|141256747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.006||95.0|-0.41|-0.07||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ non-nose/eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ N-N/E symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ non-nose/eye symptoms score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.07|-0.41|0.006
70885372|NCT00653224|141256748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.003||95.0|-0.47|-0.1||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ non-nose/eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ N-N/E symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ non-nose/eye symptoms score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.10|-0.47|0.003
70885373|NCT00653224|141256749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||<|0.001||95.0|-0.61|-0.18||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ practical problems score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ practical pbs. score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ practical problems score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.18|-0.61|<0.001
70885374|NCT00653224|141256750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|||<|0.001||95.0|-0.57|-0.16||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ practical problems score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ practical pbs. score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ practical problems score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.16|-0.57|<0.001
70885375|NCT00653224|141256751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.001||95.0|-0.61|-0.18||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ practical problems score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ practical pbs. score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ practical problems score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.18|-0.61|<0.001
70885376|NCT00653224|141256752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|||<|0.001||95.0|-0.59|-0.18||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ nasal symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ nasal symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ nasal symptoms score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.18|-0.59|<0.001
70885377|NCT00653224|141256753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|||<|0.001||95.0|-0.55|-0.16||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ nasal symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ nasal symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ nasal symptoms score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.16|-0.55|<0.001
70885378|NCT00653224|141256754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|||<|0.001||95.0|-0.59|-0.17||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ nasal symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ nasal symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ nasal symptoms score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.17|-0.59|<0.001
70885379|NCT00653224|141256755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||<|0.001||95.0|-0.63|-0.21||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ eye symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ eye symptoms score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.21|-0.63|<0.001
70885380|NCT00653224|141256756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|||<|0.001||95.0|-0.56|-0.17||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ eye symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ eye symptoms score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.17|-0.56|<0.001
70885381|NCT00653224|141256757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||<|0.001||95.0|-0.63|-0.22||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ eye symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ eye symptoms score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.22|-0.63|<0.001
70885382|NCT00653224|141256758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|||<|0.001||95.0|-0.53|-0.13||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ emotional score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ emotional score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ emotional score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.13|-0.53|<0.001
70885383|NCT00653224|141256759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.001||95.0|-0.52|-0.15||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ emotional score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ emotional score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ emotional score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.15|-0.52|<0.001
70885384|NCT00653224|141256760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.001||95.0|-0.53|-0.14||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ emotional score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ emotional score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ emotional score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.14|-0.53|<0.001
70885385|NCT00653224|141256761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|||<|0.001||95.0|-1.32|-0.45||If the p-value of this estimated difference is lower than 5% the mean T5SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the mean of T5SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean T5SS over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.45|-1.32|<0.001
70885386|NCT00653224|141256762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|||<|0.001||95.0|-1.39|-0.36||If the p-value of this estimated difference is lower than 5% the mean T5SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the mean of T5SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean T5SS over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.36|-1.39|<0.001
70885387|NCT00653224|141256763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|||<|0.001||95.0|-1.2|-0.49||If the p-value of this estimated difference is lower than 5% the mean T4SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean T4SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean T4SS over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.49|-1.20|<0.001
70885388|NCT00653224|141256764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76|||<|0.001||95.0|-1.18|-0.35||If the p-value of this estimated difference is lower than 5% the mean T4SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean T4SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean T4SS over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.35|-1.18|<0.001
70885389|NCT00653224|141256765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81|||<|0.001||95.0|-1.17|-0.45||If the p-value of this estimated difference is lower than 5% the mean T4SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean T4SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean T4SS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.45|-1.17|<0.001
70885390|NCT00653224|141256766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|||<|0.001||95.0|-1.17|-0.31||If the p-value of this estimated difference is lower than 5% the mean TNSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TNSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean TNSS over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.31|-1.17|<0.001
70885391|NCT00653224|141256767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74||||0.005||95.0|-1.26|-0.22||If the p-value of this estimated difference is lower than 5% the mean TNSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TNSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean TNSS over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.22|-1.26|0.005
70885392|NCT00653224|141256768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|||<|0.001||95.0|-1.18|-0.3||If the p-value of this estimated difference is lower than 5% the mean TNSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TNSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean TNSS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.30|-1.18|<0.001
70885393|NCT00653224|141256769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||<|0.001||95.0|-0.87|-0.3||If the p-value of this estimated difference is lower than 5% the mean TOSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TOSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean TOSS over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.30|-0.87|<0.001
70885394|NCT00653224|141256770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.001||95.0|-0.91|-0.24||If the p-value of this estimated difference is lower than 5% the mean TOSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TOSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean TOSS over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.24|-0.91|<0.001
70885395|NCT00653224|141256771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.001||95.0|-0.86|-0.28||If the p-value of this estimated difference is lower than 5% the mean TOSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TOSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean TOSS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.28|-0.86|<0.001
70885396|NCT00653224|141256772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|||<|0.001||95.0|-0.34|-0.13||If the p-value of this estimated difference is lower than 5% the sneezing mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Sneezing Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The sneezing mean score over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.13|-0.34|<0.001
70885397|NCT00653224|141256773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|||<|0.001||95.0|-0.34|-0.09||If the p-value of this estimated difference is lower than 5% the sneezing mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Sneezing Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The sneezing mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.09|-0.34|<0.001
70885398|NCT00653224|141256774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|||<|0.001||95.0|-0.33|-0.12||If the p-value of this estimated difference is lower than 5% the sneezing mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Sneezing Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The sneezing mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.12|-0.33|<0.001
70885399|NCT00653224|141256775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|||<|0.001||95.0|-0.32|-0.11||If the p-value of this estimated difference is lower than 5% the rhinorrhea mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Rhinorrhea Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The rhinorrhea mean score over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.11|-0.32|<0.001
70885400|NCT00653224|141256776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.008||95.0|-0.3|-0.05||If the p-value of this estimated difference is lower than 5% the rhinorrhea mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Rhinorrhea Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The rhinorrhea mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.05|-0.30|0.008
70885401|NCT00653224|141256777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|||<|0.001||95.0|-0.3|-0.09||If the p-value of this estimated difference is lower than 5% the rhinorrhea mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Rhinorrhea Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The rhinorrhea mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.09|-0.30|<0.001
70885402|NCT00653224|141256778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.384||95.0|-0.15|0.06||If the p-value of this estimated difference is lower than 5% the nasal congestion mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Congestion Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The nasal congestion mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.06|-0.15|0.384
70885403|NCT00653224|141256779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.063||95.0|-0.24|0.01||If the p-value of this estimated difference is lower than 5% the nasal congestion mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Congestion Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The nasal congestion mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.01|-0.24|0.063
70885404|NCT00653224|141256780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.124||95.0|-0.19|0.02||If the p-value of this estimated difference is lower than 5% the nasal congestion mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Congestion Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The nasal congestion mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.02|-0.19|0.124
70885405|NCT00653224|141256781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.002||95.0|-0.28|-0.06||If the p-value of this estimated difference is lower than 5% the nasal pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The nasal pruritus mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.06|-0.28|0.002
70885406|NCT00653224|141256782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.016||95.0|-0.28|-0.03||If the p-value of this estimated difference is lower than 5% the nasal pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The nasal pruritus mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.03|-0.28|0.016
70963566|NCT00578786|141431986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|2.593|||TWO_SIDED|95.0|-0.33|0.74|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||0.74|-0.33|
70885407|NCT00653224|141256783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.003||95.0|-0.27|-0.06||If the p-value of this estimated difference is lower than 5% the nasal pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The nasal pruritus mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.06|-0.27|0.003
70885408|NCT00653224|141256784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.088||95.0|-0.2|0.01||If the p-value of this estimated difference is lower than 5% the post-nasal drip mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Post-Nasal Drip Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The post-nasal drip mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.01|-0.20|0.088
70885409|NCT00653224|141256785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.117||95.0|-0.23|0.03||If the p-value of this estimated difference is lower than 5% the post-nasal drip mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Post-Nasal Drip Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The post-nasal drip mean score over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.03|-0.23|0.117
70885410|NCT00653224|141256786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.065||95.0|-0.21|0.01||If the p-value of this estimated difference is lower than 5% the post-nasal drip mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Post-Nasal Drip Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The post-nasal drip mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.01|-0.21|0.065
70885411|NCT00653224|141256787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|||<|0.001||95.0|-0.32|-0.1||If the p-value of this estimated difference is lower than 5% the ocular pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular pruritus mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.10|-0.32|<0.001
70885412|NCT00653224|141256788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.002||95.0|-0.33|-0.08||If the p-value of this estimated difference is lower than 5% the ocular pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular pruritus mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.08|-0.33|0.002
70885413|NCT00653224|141256789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|||<|0.001||95.0|-0.32|-0.1||If the p-value of this estimated difference is lower than 5% the ocular pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular pruritus mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.10|-0.32|<0.001
70885414|NCT00653224|141256790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|||<|0.001||95.0|-0.3|-0.08||If the p-value of this estimated difference is lower than 5% the ocular itching/burning mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Itching/Burning Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular itching/burning mean score over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.08|-0.30|<0.001
70885415|NCT00653224|141256791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.006||95.0|-0.29|-0.05||If the p-value of this estimated difference is lower than 5% the ocular itching/burning mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Itching/Burning Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular itching/burning mean score over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.05|-0.29|0.006
70885416|NCT00653224|141256792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|||<|0.001||95.0|-0.29|-0.08||If the p-value of this estimated difference is lower than 5% the ocular itching/burning mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Itching/Burning Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular itching/burning mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.08|-0.29|<0.001
70885417|NCT00653224|141256793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||<|0.001||95.0|-0.31|-0.1||If the p-value of this estimated difference is lower than 5% the ocular tearing/watering mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Tearing/Watering Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular tearing/watering mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.10|-0.31|<0.001
70885418|NCT00653224|141256794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.011||95.0|-0.29|-0.04||If the p-value of this estimated difference is lower than 5% the ocular tearing/watering mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Tearing/Watering Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular tearing/watering mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.04|-0.29|0.011
70885419|NCT00653224|141256795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|||<|0.001||95.0|-0.29|-0.08||If the p-value of this estimated difference is lower than 5% the ocular tearing/watering mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Tearing/Watering Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular tearing/watering mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.08|-0.29|<0.001
70885420|NCT00653224|141256796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.004||95.0|-0.27|-0.05||If the p-value of this estimated difference is lower than 5% the ocular redness mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Redness Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular redness mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.05|-0.27|0.004
70885421|NCT00653224|141256797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|||<|0.001||95.0|-0.34|-0.1||If the p-value of this estimated difference is lower than 5% the ocular redness mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Redness Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular redness mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.10|-0.34|<0.001
70885422|NCT00653224|141256798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|||<|0.001||95.0|-0.29|-0.08||If the p-value of this estimated difference is lower than 5% the ocular redness mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Redness Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular redness mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.08|-0.29|<0.001
70885423|NCT00653224|141256799|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||If the p-value is lower than 5% the distribution is considered as different between the two treatment groups.|Wilcoxon (Mann-Whitney)|||The Wilcoxon-Mann-Whitney, or Wilcoxon rank-sum test is generally used to detect 'shift alternatives'. That is, the two distributions have the same general shape, but one of them is shifted relative to the other by a constant amount under the alternative hypothesis.||||<0.001
70885424|NCT00653224|141256800|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||If the p-value is lower than 5% the distribution is considered as different between the two treatment groups.|Wilcoxon (Mann-Whitney)|||The Wilcoxon-Mann-Whitney, or Wilcoxon rank-sum test (Lehmann, 1975 page 23) is generally used to detect 'shift alternatives'. That is, the two distributions have the same general shape, but one of them is shifted relative to the other by a constant amount under the alternative hypothesis.||||<0.001
70885425|NCT00653224|141256801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36||||0.027||95.0|-2.56|-0.16||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 1) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 1) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.16|-2.56|0.027
70885426|NCT00653224|141256802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.554||95.0|-1.56|0.84||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 1) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 1) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.84|-1.56|0.554
70885427|NCT00653224|141256803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.015||95.0|-2.72|-0.29||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 1) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 1) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.29|-2.72|0.015
70885428|NCT00653224|141256804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6||||0.016||95.0|-8.34|-0.86||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 2) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 2) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.86|-8.34|0.016
70963567|NCT00578786|141431986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14|STANDARD_DEVIATION|2.514|||TWO_SIDED|95.0|-0.51|0.22|||||Applies to Ambrisentan 5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||0.22|-0.51|
70885429|NCT00653224|141256805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.33||||0.017||95.0|-7.88|-0.79||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 2) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 2) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.79|-7.88|0.017
70885430|NCT00653224|141256806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.25||||0.027||95.0|-8.02|-0.47||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 2) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 2) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.47|-8.02|0.027
70885431|NCT00653224|141256807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.44||||0.023||95.0|-8.25|-0.63||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 3) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 3) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.63|-8.25|0.023
70885432|NCT00653224|141256808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.56||||0.015||95.0|-8.23|-0.89||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 3) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 3) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.89|-8.23|0.015
70885433|NCT00653224|141256809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.11||||0.036||95.0|-7.95|-0.27||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 3) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 3) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.27|-7.95|0.036
70885434|NCT00653224|141256810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.51||||0.102||95.0|-9.95|0.93||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 4) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 4) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.93|-9.95|0.102
70885435|NCT00653224|141256811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.44||||0.493||95.0|-5.66|2.78||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 4) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 4) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||2.78|-5.66|0.493
70885436|NCT00653224|141256812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.38||||0.117||95.0|-9.91|1.15||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 4) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 4) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||1.15|-9.91|0.117
70885437|NCT00653224|141256813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.58||||0.409||95.0|-15.65|6.49||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 5) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 5) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||6.49|-15.65|0.409
70885438|NCT00653224|141256814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.54||||0.432||95.0|-16.1|7.01||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 5) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 5) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||7.01|-16.10|0.432
70885439|NCT00653224|141256815|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.24||||0.45||95.0|-15.46|6.99||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 5) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 5) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||6.99|-15.46|0.450
70885440|NCT00653224|141256816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.37||||0.251||95.0|-17.4|4.67||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 6) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 6) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||4.67|-17.40|0.251
70885441|NCT00653224|141256817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.06||||0.258||95.0|-19.48|5.36||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 6) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 6) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||5.36|-19.48|0.258
70885442|NCT00653224|141256818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.96||||0.288||95.0|-17.13|5.22||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 6) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 6) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||5.22|-17.13|0.288
70885443|NCT00653224|141256819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.91|||<|0.001||95.0|-9.34|-2.47||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 7) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 7) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-2.47|-9.34|<0.001
70885444|NCT00653224|141256820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.62|||<|0.001||95.0|-9.88|-3.35||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 7) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 7) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-3.35|-9.88|<0.001
70885445|NCT00653224|141256821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.69||||0.001||95.0|-9.16|-2.21||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 7) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 7) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-2.21|-9.16|0.001
70885446|NCT00653224|141256822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.027||95.0|-1.29|-0.08||If the p-value of this estimated difference is lower than 5% the mean change from baseline in ESS score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in ESS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in ESS score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.08|-1.29|0.027
70885447|NCT00653224|141256823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.535||95.0|-0.7|0.37||If the p-value of this estimated difference is lower than 5% the mean change from baseline in ESS score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in ESS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in ESS score at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.37|-0.70|0.535
70885448|NCT00653224|141256824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.042||95.0|-1.26|-0.02||If the p-value of this estimated difference is lower than 5% the mean change from baseline in ESS score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in ESS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in ESS score at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.02|-1.26|0.042
70963568|NCT00578786|141431986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48|STANDARD_DEVIATION|2.215|||TWO_SIDED|95.0|-0.93|-0.03|||||Applies to Ambrisentan 10 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||-0.03|-0.93|
70885449|NCT00653224|141256825|SUPERIORITY_OR_OTHER|||||||0.171||95.0||||If the p-value of this estimated difference is lower than 5% the change from baseline is considered as different between the two treatment groups.|Repeated measure analysis (CATMOD)|||The Null Hypothesis is expressed as follows: 'The change from baseline to endpoint visit in score category (ESS score \< 8 or \>= 8) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||||0.171
70885450|NCT04482179|141256826|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<.05
70885451|NCT04482179|141256827|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<.05
70885452|NCT02489318|141256839|SUPERIORITY||Hazard Ratio (HR)|0.484|||<|0.0001|TWO_SIDED|95.0|0.391|0.6|||Log Rank|||||0.600|0.391|<0.0001
70885453|NCT02489318|141256840|SUPERIORITY||Hazard Ratio (HR)|0.651|||<|0.0001|TWO_SIDED|95.0|0.534|0.793|||Log Rank|||||0.793|0.534|<0.0001
70885454|NCT02489318|141256841|SUPERIORITY||Hazard Ratio (HR)|0.469|||<|0.0001|TWO_SIDED|95.0|0.35|0.63|||Log Rank|||||0.630|0.350|<.0001
70885455|NCT02489318|141256842|SUPERIORITY||Hazard Ratio (HR)|0.868||||0.1966|TWO_SIDED|95.0|0.7|1.076|||Log Rank|||||1.076|0.700|0.1966
70885456|NCT02489318|141256843|SUPERIORITY||Hazard Ratio (HR)|0.794||||0.1563|TWO_SIDED|95.0|0.576|1.094|||Log Rank|||||1.094|0.576|0.1563
70885457|NCT02489318|141256844|SUPERIORITY||Hazard Ratio (HR)|0.857||||0.3608|TWO_SIDED|95.0|0.615|1.194|||Log Rank|||||1.194|0.615|0.3608
70885458|NCT01276314|141256866|OTHER|||||||0.01||||||The p-value was analyzed for SJS/TEN participants with \>10% body surface area detachment.|Kaplan-Meier analysis|||For evaluating the time taken to heal skin erosion, the Kaplan-Meier product-limit estimates method was performed. Differences were considered statistically significant at P values of less than 0.05.||||0.01
70885459|NCT01276314|141256866|OTHER|||||||0.06||||||This p-value was analyzed for DRESS participants.|Kaplan-Meier analysis|||For evaluating the time taken to heal skin erosion, the Kaplan-Meier product-limit estimates method was performed. Differences were considered statistically significant at P values of less than 0.05.||||0.06
70885460|NCT04027218|141256877|SUPERIORITY||Odds Ratio (OR)|2.57||||0.001|TWO_SIDED|95.0|2.34|2.79|||McNemar|||||2.79|2.34|0.001
70885461|NCT04027218|141256877|SUPERIORITY||Odds Ratio (OR)|1.92||||0.002|TWO_SIDED|95.0|1.7|2.13|||McNemar|||||2.13|1.70|0.002
70885462|NCT04027218|141256877|SUPERIORITY||Odds Ratio (OR)|1.9||||0.004|TWO_SIDED|95.0|1.87|1.92|||McNemar|||||1.92|1.87|0.004
70885463|NCT04027218|141256878|SUPERIORITY||Median Difference (Net)|-4.179||||0|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.000
70885464|NCT04027218|141256878|SUPERIORITY||Median Difference (Net)|-3.619||||0|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.000
70885465|NCT04027218|141256878|SUPERIORITY||Median Difference (Net)|-4.099||||0|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.000
70885466|NCT04027218|141256879|SUPERIORITY||Median Difference (Net)|-1.073||||0.863|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the number of negative changes, which implies participants with decrease in VAS score.|||||0.863
70885467|NCT04027218|141256879|SUPERIORITY||Median Difference (Net)|-1.267||||0.205|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the number of negative changes, which implies participants with decrease in VAS score.|||||0.205
70885468|NCT04027218|141256879|SUPERIORITY||Median Difference (Net)|-0.858||||0.391|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the number of negative changes, which implies participants with decrease in VAS score.|||||0.391
70885469|NCT04027218|141256881|SUPERIORITY||Median Difference (Net)|-0.672||||0.502|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the absorbance comparing hemolysis in blood samples performed by clinical practice against to the corresponding intervention.|||||0.502
70885470|NCT04027218|141256881|SUPERIORITY||Median Difference (Net)|-0.327||||0.744|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the absorbance comparing hemolysis in blood samples performed by clinical practice against to the corresponding intervention.|||||0.744
70885471|NCT04027218|141256881|SUPERIORITY||Median Difference (Net)|-1.885||||0.059|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the absorbance comparing hemolysis in blood samples performed by clinical practice against to the corresponding intervention.|||||0.059
70885472|NCT05107128|141256890|SUPERIORITY||Difference in Least Square (LS) Means|-1.1|STANDARD_ERROR_OF_MEAN|0.81||0.1675|TWO_SIDED|95.0|-2.7|0.5||The p-value was obtained from Mixed Model for Repeated Measures (MMRM) model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and SDMT score at baseline as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||0.5|-2.7|0.1675
70885473|NCT05107128|141256891|SUPERIORITY||Difference in LS Means|-0.6|STANDARD_ERROR_OF_MEAN|0.9||0.4872|TWO_SIDED|95.0|-2.4|1.1||The p-value was obtained from MMRM model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and UHDRS - Independence Scale at baseline as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||1.1|-2.4|0.4872
70885474|NCT05107128|141256892|SUPERIORITY||Difference in LS Means|-5.0|STANDARD_ERROR_OF_MEAN|6.04||0.4089|TWO_SIDED|95.0|-17.0|6.9||The p-value was obtained from MMRM model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and SDMT score at baseline as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||6.9|-17.0|0.4089
70885475|NCT05107128|141256893|SUPERIORITY||Difference in LS Means|0.7|STANDARD_ERROR_OF_MEAN|1.26||0.5766|TWO_SIDED|95.0|-1.78|3.19||The p-value was obtained from MMRM model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and a baseline value as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||3.19|-1.78|0.5766
70885476|NCT05107128|141256894|SUPERIORITY||Difference in LS Means|-0.86|STANDARD_ERROR_OF_MEAN|0.64||0.1777|TWO_SIDED|95.0|-2.13|0.39||The p-value was obtained from MMRM model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and baseline value as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||0.39|-2.13|0.1777
70885477|NCT05107128|141256895|SUPERIORITY||Difference in LS Means|3.9|STANDARD_ERROR_OF_MEAN|1.76||0.0291|TWO_SIDED|95.0|0.4|7.3||The p-value was obtained from MMRM model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and Hi-DEF at baseline as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||7.3|0.4|0.0291
70963569|NCT00578786|141431986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14|STANDARD_DEVIATION|2.467|||TWO_SIDED|95.0|-0.39|0.11|||||Applies to Ambrisentan combined group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||0.11|-0.39|
70885478|NCT05107128|141256896|SUPERIORITY||Difference in LS Means|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.2923|TWO_SIDED|95.0|-0.3|0.1||The p-value was obtained from MMRM model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and CGI at baseline as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||0.1|-0.3|0.2923
70885479|NCT04988295|141256905|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.35|0.56|||Log Rank|||||0.56|0.35|<0.0001
70885480|NCT04988295|141256905|SUPERIORITY||Hazard Ratio (HR)|0.48|||<|0.0001||95.0|0.36|0.64|||Log Rank|||||0.64|0.36|<0.0001
70885481|NCT04649151|141256926|NON_INFERIORITY|The noninferiority of Geometric Mean value (based on geometric least squares means \[GLSM\]) was considered demonstrated if: The lower bound of the 95% confidence interval (CI) of the geometric mean ratio (GMR) was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold).|GMR|1.078|||||TWO_SIDED|95.0|0.94|1.237|||||GMR of P203 vs P301|||1.237|0.940|
70885482|NCT04649151|141256927|NON_INFERIORITY|Noninferiority margin of 10%. Lower bound of the 95% CI of the SRR difference \>-10%. and a point estimator \>-5% (minimum threshold)|percentage difference|-0.2|||||TWO_SIDED|95.0|-2.1|1.9|||||SRR difference of P203 vs P301|||1.9|-2.1|
70885483|NCT04649151|141256928|NON_INFERIORITY|The lower bound of the 95% CI of noninferiority margin of 1.5. GMR point estimate \>=0.8 (minimum threshold).|GMR|5.071|||||TWO_SIDED|95.0|4.477|5.745|||||GMR of GMC at BD-Day 29 P203 vs GMC at Day 57 P301|||5.745|4.477|
70885484|NCT04649151|141256929|NON_INFERIORITY|Noninferiority margin of 10%. Lower bound of the 95% CI of the SRR difference \>-10%.|SRR Difference|0.7|||||TWO_SIDED|95.0|-0.8|2.4|||||SRR difference of P203 BD-Day 29 vs P301 Day 57|||2.4|-0.8|
70885485|NCT04649151|141256930|SUPERIORITY|The superiority of GMC (based on GLSM\] was considered demonstrated if: The lower bound of the 95% CI of the GMR was \>1|GMR|48.191|||||TWO_SIDED|95.0|43.765|53.065|||||GMR of P203 vs P301|||53.065|43.765|
70885486|NCT04649151|141256933|NON_INFERIORITY|The noninferiority of Geometric Mean value (based on GLSM) was considered demonstrated if: The lower bound of the 95% CI of the GMR was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold).|GMR|4.493|||||TWO_SIDED|95.0|3.972|5.083|||||GMR of GMC at BD-Day 29 P203 vs GMC at Day 57 P301|||5.083|3.972|
70885487|NCT04649151|141256936|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|VE|60.3|||||TWO_SIDED|95.0|26.6|78.6|||VE|Vaccine efficacy (VE, percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).||||78.6|26.6|
70885488|NCT04649151|141256937|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|VE|43.5|||||TWO_SIDED|95.0|-16.5|72.2|||VE|VE (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).||||72.2|-16.5|
70885489|NCT04649151|141256938|OTHER||VE|100.0|||||TWO_SIDED|95.0|61.2||NA = not estimable (not reached).||VE|VE (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.||||61.2|
70885490|NCT04649151|141256939|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|VE|89.9|||||TWO_SIDED|95.0|51.0|98.9|||VE|VE (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).||||98.9|51.0|
70885491|NCT00433654|141257006|SUPERIORITY_OR_OTHER_LEGACY||Percentage|0.0|||<|0.001|ONE_SIDED|95.0||1.7|||exact test of binomial proportions|||Null hypothesis: rate \> 10%||1.7||<0.001
70885492|NCT00433654|141257007|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 10%.|Difference in percentages|0.0||||||95.0||||P-value and confidence interval could not be calculated because both groups were 100% successful.|Farrington-Manning|||Null hypothesis: success rate MRI group \<= success rate control group - 10%||||
70885493|NCT00433654|141257008|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 10%.|Difference in percentages|0.5|||<|0.001||95.0|||||Farrington-Manning|||Null hypothesis: success rate MRI group \<= success rate control group - 10%||||<0.001
70885494|NCT00433654|141257009|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 10%.|Difference in percentages|1.9|||<|0.001||95.0|||||Farrington-Manning|||Null hypothesis: success rate MRI group \<= success rate control group - 10%||||<0.001
70885495|NCT00433654|141257010|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 10%.|Difference in percentages|2.1|||<|0.001||95.0|||||Farrington-Manning|||Null hypothesis: success rate MRI group \<= success rate control group - 10%||||<0.001
70885496|NCT00433654|141257011|SUPERIORITY_OR_OTHER_LEGACY||Percentage|8.3|||<|0.001|ONE_SIDED|95.0||10.7|||exact test of binomial proportions|||Null hypothesis: Percentage of subjects with complication \> 20%||10.7||<0.001
70885497|NCT05320029|141257030|NON_INFERIORITY|If the two-side 95%CI limit of the difference between the two groups is greater than the non-inferiority margin of -10%, the non-inferiority hypothesis of this study is valid|Mean Difference (Final Values)|0.0|||<|0.05|TWO_SIDED|95.0|-0.0458|0.0458|||Newcombe-Wilson|||||0.0458|-0.0458|<0.05
70885498|NCT02703636|141257119|OTHER|The MMRM model contained visit as a fixed effect, baseline MMSE score as a covariate and patient as a random effect.|Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.259||0.175|TWO_SIDED|95.0|-0.87|0.16|||t-test, 2 sided||change at week 24|||0.16|-0.87|0.1750
70885499|NCT00393939|141257127|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9222||||0.2651|TWO_SIDED|95.0|0.7156|1.1885||1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)|Log Rank|||Independent radiology assessment||1.1885|0.7156|0.2651
70885500|NCT00393939|141257127|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.856||||0.0753|TWO_SIDED|95.0|0.6921|1.0589||1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)|Log Rank|||Investigator's assessment||1.0589|0.6921|0.0753
70885501|NCT00393939|141257128|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.0018|TWO_SIDED|95.0|1.17|2.33||1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)|Cochran-Mantel-Haenszel|||Independent radiology assessment||2.33|1.17|0.0018
70885502|NCT00393939|141257128|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.0172|TWO_SIDED|95.0|1.03|2.02||1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)|Cochran-Mantel-Haenszel|||Investigator's assessment||2.02|1.03|0.0172
70885503|NCT00393939|141257130|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1539||||0.8933|TWO_SIDED|95.0|0.9209|1.4458||1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)|Log Rank|||||1.4458|0.9209|0.8933
70885504|NCT00384813|141257191|SUPERIORITY_OR_OTHER||regression coefficient|0.33||||0.23||||||For both baseline to 4 month analyses (see above p value) and baseline to 10 month analyses, the variable of intervention group did not contribute significant additional variance.|Regression, Linear|||||||0.23
70885505|NCT00167934|141257198|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||< 0.0001
70885506|NCT00167934|141257199|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED||||||ANCOVA|||||||0.04
70885507|NCT04951622|141257202|SUPERIORITY||Difference of LS Means|-1.45|STANDARD_ERROR_OF_MEAN|0.47|=|0.002|TWO_SIDED|95.0|-2.38|-0.52|||mixed effects model for repeated measure|||||-0.52|-2.38|=0.002
70885508|NCT04108208|141257231|SUPERIORITY||Hazard Ratio (HR)|0.233|||=|0.0052|TWO_SIDED|95.0|0.077|0.705|||Log Rank|||||0.705|0.077|=0.0052
70885509|NCT00409292|141257263|SUPERIORITY_OR_OTHER|||||||0.1|||||||binomial hypothesis test|||||||0.10
70885510|NCT02942017|141257294|SUPERIORITY||Least Square (LS) Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|1.019||0.016|TWO_SIDED|95.0|-4.52|-0.48|||MMRM|||Mixed effect model for repeated measures (MMRM) was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.48|-4.52|0.0160
70885511|NCT02942017|141257295|SUPERIORITY||LS Mean Difference|0.54|STANDARD_ERROR_OF_MEAN|1.271||0.671|TWO_SIDED|95.0|-1.98|3.07|||MMRM|||MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||3.07|-1.98|0.6710
70885512|NCT02942017|141257296|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.738||0.4216|TWO_SIDED|95.0|-2.06|0.87|||MMRM|||Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.87|-2.06|0.4216
70885513|NCT02942017|141257296|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.905||0.3947|TWO_SIDED|95.0|-2.57|1.02|||MMRM|||Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.02|-2.57|0.3947
70885514|NCT02942017|141257296|SUPERIORITY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.962||0.328|TWO_SIDED|95.0|-2.86|0.96|||MMRM|||Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.96|-2.86|0.3280
70885515|NCT02942017|141257296|SUPERIORITY||LS Mean Difference|-1.14|STANDARD_ERROR_OF_MEAN|0.994||0.2522|TWO_SIDED|95.0|-3.12|0.83|||MMRM|||Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.83|-3.12|0.2522
70885516|NCT02942017|141257296|SUPERIORITY||LS Mean Difference|-1.61|STANDARD_ERROR_OF_MEAN|1.091||0.1431|TWO_SIDED|95.0|-3.78|0.55|||MMRM|||Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.55|-3.78|0.1431
70885517|NCT02942017|141257296|SUPERIORITY||LS Mean Difference|-1.85|STANDARD_ERROR_OF_MEAN|1.113||0.0991|TWO_SIDED|95.0|-4.06|0.36|||MMRM|||Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.36|-4.06|0.0991
70885518|NCT02942017|141257296|SUPERIORITY||LS Mean Difference|-2.42|STANDARD_ERROR_OF_MEAN|1.155||0.0389|TWO_SIDED|95.0|-4.71|-0.13|||MMRM|||Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.13|-4.71|0.0389
70885519|NCT02942017|141257296|SUPERIORITY||LS Mean Difference|-3.48|STANDARD_ERROR_OF_MEAN|1.108||0.0022|TWO_SIDED|95.0|-5.67|-1.28|||MMRM|||Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.28|-5.67|0.0022
70963570|NCT05105789|141431999|SUPERIORITY|"One-sample binomial test. Null hypothesis: NPV of BinaxNOW at Home testing is at most 91%.~Alternative hypothesis: NPV of BinaxNOW at Home testing is greater than 91%."|Kappa Co-efficient|100.0||||0.0015|TWO_SIDED|95.0|95.0|100.0|||one-sample binomial test||binary outcome|Negative Predictive Value||100|95|0.0015
70885520|NCT02942017|141257296|SUPERIORITY||LS Mean Difference|-3.24|STANDARD_ERROR_OF_MEAN|1.429||0.0255|TWO_SIDED|95.0|-6.08|-0.4|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.40|-6.08|0.0255
70885521|NCT02942017|141257296|SUPERIORITY||LS Mean Difference|-2.03|STANDARD_ERROR_OF_MEAN|1.356||0.1375|TWO_SIDED|95.0|-4.73|0.66|||MMRM|||Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.66|-4.73|0.1375
70885522|NCT02942017|141257296|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|1.4||0.817|TWO_SIDED|95.0|-3.11|2.46|||MMRM|||Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.46|-3.11|0.8170
70885523|NCT02942017|141257297|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0168|TWO_SIDED|95.0|1.2|6.7|||GEE method|||Hour 60: Generalized estimating equation (GEE) method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model.||6.7|1.2|0.0168
70885524|NCT02942017|141257297|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0482|TWO_SIDED|95.0|1.0|6.6|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model.||6.6|1.0|0.0482
70885525|NCT02942017|141257297|SUPERIORITY||Odds Ratio (OR)|0.8||||0.5857|TWO_SIDED|95.0|0.3|2.0|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||2.0|0.3|0.5857
70885526|NCT02942017|141257298|SUPERIORITY||Odds Ratio (OR)|3.4||||0.0033|TWO_SIDED|95.0|1.5|7.9||Hour 60:|GEE method|||Hour 60: GEE method was used for analysis. The HAM-D remission at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||7.9|1.5|0.0033
70885527|NCT02942017|141257298|SUPERIORITY||Odds Ratio (OR)|3.7||||0.0046|TWO_SIDED|95.0|1.5|9.3|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D remission at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||9.3|1.5|0.0046
70885528|NCT02942017|141257298|SUPERIORITY||Odds Ratio (OR)|0.6||||0.3085|TWO_SIDED|95.0|0.3|1.5|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D remission at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||1.5|0.3|0.3085
70885529|NCT02942017|141257299|SUPERIORITY||LS mean difference|-8.35|STANDARD_ERROR_OF_MEAN|2.989||0.0063|TWO_SIDED|95.0|-14.29|-2.42|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit was the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||-2.42|-14.29|0.0063
70885530|NCT02942017|141257299|SUPERIORITY||LS mean difference|-9.75|STANDARD_ERROR_OF_MEAN|3.566||0.0074|TWO_SIDED|95.0|-16.83|-2.68|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit was the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||-2.68|-16.83|0.0074
70885531|NCT02942017|141257299|SUPERIORITY||LS mean difference|1.37|STANDARD_ERROR_OF_MEAN|3.149||0.6637|TWO_SIDED|95.0|-4.88|7.63|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit was the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||7.63|-4.88|0.6637
70885532|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.154||0.5132|TWO_SIDED|95.0|-0.41|0.21|||MMRM|||Depressed Mood, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.41|0.5132
70885533|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.181||0.1672|TWO_SIDED|95.0|-0.61|0.11|||MMRM|||Depressed Mood, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.61|0.1672
70885534|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.178||0.0963|TWO_SIDED|95.0|-0.65|0.05|||MMRM|||Depressed Mood, Hour 8:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.65|0.0963
70885535|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.183||0.4803|TWO_SIDED|95.0|-0.49|0.23|||MMRM|||Depressed Mood, Hour 12:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.49|0.4803
70885536|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.191||0.0844|TWO_SIDED|95.0|-0.71|0.05|||MMRM|||Depressed Mood, Hour 24:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.71|0.0844
70885537|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.193||0.1325|TWO_SIDED|95.0|-0.68|0.09|||MMRM|||Depressed Mood, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.68|0.1325
70885538|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.192||0.0332|TWO_SIDED|95.0|-0.79|-0.03|||MMRM|||Depressed Mood, Hour 48:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.79|0.0332
70885539|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.189||0.1273|TWO_SIDED|95.0|-0.67|0.08|||MMRM|||Depressed Mood, Hour 60:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.67|0.1273
70885540|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.182||0.1059|TWO_SIDED|95.0|-0.66|0.06|||MMRM|||Depressed Mood, Hour 72:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.66|0.1059
70885541|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.215||0.0683|TWO_SIDED|95.0|-0.82|0.03|||MMRM|||Depressed Mood, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.82|0.0683
70885542|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.232||0.4458|TWO_SIDED|95.0|-0.64|0.28|||MMRM|||Depressed Mood, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.64|0.4458
70885543|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.228||0.2905|TWO_SIDED|95.0|-0.21|0.7|||MMRM|||Depressed Mood, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.70|-0.21|0.2905
70885544|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.182||0.3096|TWO_SIDED|95.0|-0.18|0.55|||MMRM|||Depressed Mood, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.55|-0.18|0.3096
70885545|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.165||0.1925|TWO_SIDED|95.0|-0.55|0.11|||MMRM|||Feeling of Guilt, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.55|0.1925
70963571|NCT05105789|141431999|NON_INFERIORITY|non-inferiority margin of δ=5% and a sensitivity/specificity of PCR of 99%||||||0.3308|||||||one-sample binomial test|||Sensitivity H0: Sens-0.99 ≤ 0.05 vs. HA: Sens-0.99 \> -0.05||||0.3308
70963572|NCT05105789|141431999|NON_INFERIORITY|a non-inferiority margin of δ=5% and a sensitivity/specificity of PCR of 99%||||||0.0536|||||||one-sample binomial test|||Specificity H0: Spec-0.99 ≤ 0.05 vs. HA: Spec-0.99 \> -0.05||||0.0536
70885546|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.168||0.0101|TWO_SIDED|95.0|-0.77|-0.11|||MMRM|||Feeling of Guilt, Hour 4:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.11|-0.77|0.0101
70885547|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.163||0.1546|TWO_SIDED|95.0|-0.56|0.09|||MMRM|||Feeling of Guilt, Hour 8:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.56|0.1546
70885548|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.168||0.0901|TWO_SIDED|95.0|-0.62|0.05|||MMRM|||Feeling of Guilt, Hour 12:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.62|0.0901
70885549|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.162||0.0717|TWO_SIDED|95.0|-0.62|0.03|||MMRM|||Feeling of Guilt, Hour 24:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.62|0.0717
70885550|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.169||0.0468|TWO_SIDED|95.0|-0.68|0.0|||MMRM|||Feeling of Guilt, Hour 36:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.68|0.0468
70885551|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.173||0.2222|TWO_SIDED|95.0|-0.56|0.13|||MMRM|||Feeling of Guilt, Hour 48:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.56|0.2222
70885552|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.156||0.0682|TWO_SIDED|95.0|-0.6|0.02|||MMRM|||Feeling of Guilt, Hour 60:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.60|0.0682
70885553|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.16||0.0147|TWO_SIDED|95.0|-0.72|-0.08|||MMRM|||Feeling of Guilt, Hour 72:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.08|-0.72|0.0147
70885554|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.182||0.0837|TWO_SIDED|95.0|-0.68|0.04|||MMRM|||Feeling of Guilt, Day 7:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.68|0.0837
70885555|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.179||0.5828|TWO_SIDED|95.0|-0.46|0.26|||MMRM|||Feeling of Guilt, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.46|0.5828
70885556|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.168||0.5674|TWO_SIDED|95.0|-0.43|0.24|||MMRM|||Feeling of Guilt, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.43|0.5674
70885557|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.145||0.4613|TWO_SIDED|95.0|-0.18|0.4|||MMRM|||Feeling of Guilt, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.40|-0.18|0.4613
70885558|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.082||0.324|TWO_SIDED|95.0|-0.24|0.08|||MMRM|||Suicide, Hour 2:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.24|0.3240
70885559|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.082||0.3023|TWO_SIDED|95.0|-0.24|0.08|||MMRM|||Suicide, Hour 4:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.24|0.3023
70885560|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.082||0.4127|TWO_SIDED|95.0|-0.23|0.09|||MMRM|||Suicide, Hour 8:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.23|0.4127
70885561|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.082||0.2819|TWO_SIDED|95.0|-0.25|0.07|||MMRM|||Suicide, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.25|0.2819
70885562|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.082||0.3884|TWO_SIDED|95.0|-0.23|0.09|||MMRM|||Suicide, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.23|0.3884
70885563|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.082||0.275|TWO_SIDED|95.0|-0.25|0.07|||MMRM|||Suicide, Hour 36:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.25|0.2750
70885564|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.082||0.1811|TWO_SIDED|95.0|-0.27|0.05|||MMRM|||Suicide, Hour 48:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.27|0.1811
70885565|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.082||0.3854|TWO_SIDED|95.0|-0.23|0.09|||MMRM|||Suicide, Hour 60:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.23|0.3854
70885566|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.082||0.3822|TWO_SIDED|95.0|-0.23|0.09|||MMRM|||Suicide, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.23|0.3822
70885567|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.082||0.9255|TWO_SIDED|95.0|-0.17|0.15|||MMRM|||Suicide, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.17|0.9255
70885568|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.091||0.6714|TWO_SIDED|95.0|-0.14|0.22|||MMRM|||Suicide, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.14|0.6714
70885569|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.091||0.9838|TWO_SIDED|95.0|-0.18|0.18|||MMRM|||Suicide, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.18|0.9838
70885570|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.083||0.8884|TWO_SIDED|95.0|-0.17|0.15|||MMRM|||Suicide, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.17|0.8884
70885571|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.097||0.6996|TWO_SIDED|95.0|-0.23|0.16|||MMRM|||Insomnia-Early, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.23|0.6996
70885572|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.121||0.4426|TWO_SIDED|95.0|-0.15|0.33|||MMRM|||Insomnia-Early, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.33|-0.15|0.4426
70885573|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.11||0.8743|TWO_SIDED|95.0|-0.2|0.24|||MMRM|||Insomnia-Early, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.20|0.8743
70885574|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.118||0.3498|TWO_SIDED|95.0|-0.12|0.35|||MMRM|||Insomnia-Early, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.12|0.3498
70885575|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.151||0.0839|TWO_SIDED|95.0|-0.56|0.04|||MMRM|||Insomnia-Early, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.56|0.0839
70885576|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.157||0.2595|TWO_SIDED|95.0|-0.49|0.13|||MMRM|||Insomnia-Early, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.49|0.2595
70885577|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.168||0.056|TWO_SIDED|95.0|-0.66|0.01|||MMRM|||Insomnia-Early, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.66|0.0560
70885578|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.18||0.6187|TWO_SIDED|95.0|-0.45|0.27|||MMRM|||Insomnia-Early, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.45|0.6187
70885579|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.163||0.0187|TWO_SIDED|95.0|-0.72|-0.07|||MMRM|||Insomnia-Early, Hour 72 MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.07|-0.72|0.0187
70885580|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.18||0.1531|TWO_SIDED|95.0|-0.62|0.1|||MMRM|||Insomnia-Early, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.62|0.1531
70885581|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.197||0.3341|TWO_SIDED|95.0|-0.58|0.2|||MMRM|||Insomnia-Early, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.58|0.3341
70885582|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.216||0.8969|TWO_SIDED|95.0|-0.4|0.46|||MMRM|||Insomnia-Early, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.40|0.8969
70885583|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.174||0.5862|TWO_SIDED|95.0|-0.25|0.44|||MMRM|||Insomnia-Early, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.44|-0.25|0.5862
70885584|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.117||0.3776|TWO_SIDED|95.0|-0.13|0.34|||MMRM|||Insomnia-Middle, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.34|-0.13|0.3776
70885585|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.121||0.9029|TWO_SIDED|95.0|-0.26|0.23|||MMRM|||Insomnia-Middle, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.26|0.9029
70885586|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.121||0.6173|TWO_SIDED|95.0|-0.18|0.3|||MMRM|||Insomnia-Middle, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.18|0.6173
70885587|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.124||0.2433|TWO_SIDED|95.0|-0.1|0.39|||MMRM|||Insomnia-Middle, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.39|-0.10|0.2433
70885588|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.139||0.0234|TWO_SIDED|95.0|-0.59|-0.04|||MMRM|||Insomnia-Middle, Hour 24 MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.04|-0.59|0.0234
70885589|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.139||0.054|TWO_SIDED|95.0|-0.55|0.0|||MMRM|||Insomnia-Middle, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.55|0.0540
70885590|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.144||0.0406|TWO_SIDED|95.0|-0.58|-0.01|||MMRM|||Insomnia-Middle, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.58|0.0406
70885591|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.132||0.0295|TWO_SIDED|95.0|-0.56|-0.03|||MMRM|||Insomnia-Middle, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.56|0.0295
70885592|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.135||0.0925|TWO_SIDED|95.0|-0.5|0.04|||MMRM|||Insomnia-Middle, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.50|0.0925
70885593|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.152||0.1631|TWO_SIDED|95.0|-0.52|0.09|||MMRM|||Insomnia-Middle, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.52|0.1631
70885594|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.185||0.2213|TWO_SIDED|95.0|-0.6|0.14|||MMRM|||Insomnia-Middle, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.60|0.2213
70885595|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.189||0.9175|TWO_SIDED|95.0|-0.36|0.39|||MMRM|||Insomnia-Middle, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.39|-0.36|0.9175
70885596|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.165||0.6763|TWO_SIDED|95.0|-0.4|0.26|||MMRM|||Insomnia-Middle, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.40|0.6763
70885597|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.121||0.3805|TWO_SIDED|95.0|-0.13|0.35|||MMRM|||Insomnia-Late, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.13|0.3805
70885598|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.127||0.6073|TWO_SIDED|95.0|-0.19|0.32|||MMRM|||Insomnia-Late, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.19|0.6073
70885599|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.119||0.7848|TWO_SIDED|95.0|-0.27|0.2|||MMRM|||Insomnia-Late, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.27|0.7848
70885600|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.121||0.9038|TWO_SIDED|95.0|-0.25|0.23|||MMRM|||Insomnia-Late, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.25|0.9038
70885601|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.134|STANDARD_ERROR_OF_MEAN|0.134||0.6869|TWO_SIDED|95.0|-0.32|0.21|||MMRM|||Insomnia-Late, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.32|0.6869
70885602|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.139||0.9272|TWO_SIDED|95.0|-0.26|0.29|||MMRM|||Insomnia-Late, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.26|0.9272
70885603|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.131||0.6931|TWO_SIDED|95.0|-0.31|0.21|||MMRM|||Insomnia-Late, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.31|0.6931
70885604|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.132||0.8262|TWO_SIDED|95.0|-0.29|0.23|||MMRM|||Insomnia-Late, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.29|0.8262
70885605|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.141||0.0749|TWO_SIDED|95.0|-0.54|0.03|||MMRM|||Insomnia-Late, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.54|0.0749
70885606|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.135||0.1923|TWO_SIDED|95.0|-0.45|0.09|||MMRM|||Insomnia-Late, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.45|0.1923
70885607|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.176||0.0326|TWO_SIDED|95.0|-0.73|-0.03|||MMRM|||Insomnia-Late, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.73|0.0326
70885608|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.171||0.444|TWO_SIDED|95.0|-0.47|0.21|||MMRM|||Insomnia-Late, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.47|0.4440
70885609|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.134||0.7057|TWO_SIDED|95.0|-0.32|0.22|||MMRM|||Insomnia-Late, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.32|0.7057
70885610|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.137||0.2865|TWO_SIDED|95.0|-0.42|0.13|||MMRM|||Work and Activities, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.42|0.2865
70885611|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.17||0.9475|TWO_SIDED|95.0|-0.33|0.35|||MMRM|||Work and Activities, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.33|0.9475
70885612|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.185||0.188|TWO_SIDED|95.0|-0.61|0.12|||MMRM|||Work and Activities, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.61|0.1880
70885613|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.203||0.595|TWO_SIDED|95.0|-0.51|0.29|||MMRM|||Work and Activities, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.51|0.5950
70885614|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.2||0.9636|TWO_SIDED|95.0|-0.39|0.41|||MMRM|||Work and Activities, Hour 24 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.41|-0.39|0.9636
70885615|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.196||0.5836|TWO_SIDED|95.0|-0.5|0.28|||MMRM|||Work and Activities, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.50|0.5836
70885616|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.184||0.1568|TWO_SIDED|95.0|-0.63|0.1|||MMRM|||Work and Activities, Hour 48 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.63|0.1568
70885617|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.177||0.0155|TWO_SIDED|5.0|-0.79|-0.09|||Wilcoxon (Mann-Whitney)|||Work and Activities, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-0.79|0.0155
70885618|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.192||0.0504|TWO_SIDED|95.0|-0.76|0.0|||MMRM|||Work and Activities, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.76|0.0504
70885619|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.212||0.1865|TWO_SIDED|95.0|-0.7|0.14|||MMRM|||Work and Activities, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.70|0.1865
70885620|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.22||0.0518|TWO_SIDED|95.0|-0.87|0.0|||MMRM|||Work and Activities, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.87|0.0518
70885621|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.239||0.833|TWO_SIDED|95.0|-0.42|0.53|||MMRM|||Work and Activities, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.53|-0.42|0.8330
70885622|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.191||0.844|TWO_SIDED|95.0|-0.34|0.42|||MMRM|||Work and Activities, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.42|-0.34|0.8440
70885623|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.121||0.4602|TWO_SIDED|95.0|-0.15|0.33|||MMRM|||Retardation, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.33|-0.15|0.4602
70885624|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.117||0.0891|TWO_SIDED|95.0|-0.03|0.43|||MMRM|||Retardation, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.03|0.0891
70885625|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.117||0.3088|TWO_SIDED|95.0|-0.11|0.35|||MMRM|||Retardation, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.11|0.3088
70885626|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.112||0.856|TWO_SIDED|95.0|-0.24|0.2|||MMRM|||Retardation, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.24|0.8560
70885627|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.125||0.9702|TWO_SIDED|95.0|-0.24|0.25|||MMRM|||Retardation, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.24|0.9702
70885628|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.114||0.8001|TWO_SIDED|95.0|-0.25|0.2|||MMRM|||Retardation, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.25|0.8001
70885629|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.109||0.3223|TWO_SIDED|95.0|-0.11|0.32|||MMRM|||Retardation, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||0.32|-0.11|0.3223
70885630|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.089||0.3385|TWO_SIDED|95.0|-0.26|0.09|||MMRM|||Retardation, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||0.09|-0.26|0.3385
70885631|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.1||0.7003|TWO_SIDED|95.0|-0.16|0.24|||MMRM|||Retardation, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||0.24|-0.16|0.7003
70885632|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.099||0.0311|TWO_SIDED|95.0|-0.41|-0.02|||MMRM|||Retardation, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||-0.02|-0.41|0.0311
70885633|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.079||0.1976|TWO_SIDED|95.0|-0.26|0.06|||MMRM|||Retardation, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||0.06|-0.26|0.1976
70885634|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.092||0.5489|TWO_SIDED|95.0|-0.24|0.13|||MMRM|||Retardation, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||0.13|-0.24|0.5489
70885635|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.075||0.7992|TWO_SIDED|95.0|-0.17|0.13|||MMRM|||Retardation, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||0.13|-0.17|0.7992
70885636|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.103||0.0573|TWO_SIDED|95.0|-0.4|0.01|||MMRM|||Agitation, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.40|0.0573
70885637|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.0431|TWO_SIDED|95.0|-0.44|-0.01|||MMRM|||Agitation, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.44|0.0431
70885638|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.108||0.006|TWO_SIDED|95.0|-0.52|-0.09|||MMRM|||Agitation, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-0.52|0.0060
70885639|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.127||0.0215|TWO_SIDED|95.0|-0.55|-0.04|||MMRM|||Agitation, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.04|-0.55|0.0215
70885640|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.109||0.0422|TWO_SIDED|95.0|-0.44|-0.01|||MMRM|||Agitation, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.44|0.0422
70885641|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.126||0.0433|TWO_SIDED|95.0|-0.51|-0.01|||MMRM|||Agitation, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.51|0.0433
70885642|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.118||0.0051|TWO_SIDED|95.0|-0.57|-0.1|||MMRM|||Agitation, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.10|-0.57|0.0051
70885643|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.133||0.0973|TWO_SIDED|95.0|-0.48|0.04|||MMRM|||Agitation, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.48|0.0973
70885644|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.126||0.0036|TWO_SIDED|95.0|-0.63|-0.13|||MMRM|||Agitation, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.13|-0.63|0.0036
70885645|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.131||0.0498|TWO_SIDED|95.0|-0.52|0.0|||MMRM|||Agitation, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.52|0.0498
70885646|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.147||0.5111|TWO_SIDED|95.0|-0.39|0.2|||MMRM|||Agitation, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.39|0.5111
70885647|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.155||0.5839|TWO_SIDED|95.0|-0.39|0.22|||MMRM|||Agitation, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.39|0.5839
70885648|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.1||0.1905|TWO_SIDED|95.0|-0.33|0.07|||MMRM|||Agitation, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.33|0.1905
70885649|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.162||0.1767|TWO_SIDED|95.0|-0.54|0.1|||MMRM|||Anxiety Psychic, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.54|0.1767
70885650|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.18||0.5182|TWO_SIDED|95.0|-0.47|0.24|||MMRM|||Anxiety Psychic, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.47|0.5182
70885651|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.185||0.393|TWO_SIDED|95.0|-0.53|0.21|||MMRM|||Anxiety Psychic, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.53|0.3930
70885652|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.189||0.5212|TWO_SIDED|95.0|-0.5|0.25|||MMRM|||Anxiety Psychic, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.50|0.5212
70885653|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.184||0.4741|TWO_SIDED|95.0|-0.5|0.23|||MMRM|||Anxiety Psychic, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.50|0.4741
70885654|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.186||0.4482|TWO_SIDED|95.0|-0.51|0.23|||MMRM|||Anxiety Psychic, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.51|0.4482
70885655|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.187||0.0963|TWO_SIDED|95.0|-0.69|0.06|||MMRM|||Anxiety Psychic, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.69|0.0963
70885656|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.171||0.003|TWO_SIDED|95.0|-0.86|-0.18|||MMRM|||Anxiety Psychic, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.18|-0.86|0.0030
70885657|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.177||0.1116|TWO_SIDED|95.0|-0.63|0.07|||MMRM|||Anxiety Psychic, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.63|0.1116
70885658|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.173||0.004|TWO_SIDED|95.0|-0.86|-0.17|||MMRM|||Anxiety Psychic, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.17|-0.86|0.0040
70885659|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.244||0.8253|TWO_SIDED|95.0|-0.54|0.43|||MMRM|||Anxiety Psychic, Day 14 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.54|0.8253
70885660|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.209||0.5795|TWO_SIDED|95.0|-0.3|0.53|||MMRM|||Anxiety Psychic, Day 21 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.53|-0.30|0.5795
70885661|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.182||0.4032|TWO_SIDED|95.0|-0.21|0.51|||MMRM|||Anxiety Psychic, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.51|-0.21|0.4032
70885662|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.133||0.6117|TWO_SIDED|95.0|-0.33|0.2|||MMRM|||Anxiety Somatic, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.33|0.6117
70885663|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.13||0.4716|TWO_SIDED|95.0|-0.35|0.16|||MMRM|||Anxiety Somatic, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.35|0.4716
70885664|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.136||0.6041|TWO_SIDED|95.0|-0.34|0.2|||MMRM|||Anxiety Somatic, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.34|0.6041
70885665|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.132||0.0424|TWO_SIDED|95.0|-0.53|-0.01|||MMRM|||Anxiety Somatic, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.53|0.0424
70885666|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.138||0.7622|TWO_SIDED|95.0|-0.32|0.23|||MMRM|||Anxiety Somatic, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.32|0.7622
70885667|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.13||0.2689|TWO_SIDED|95.0|-0.4|0.11|||MMRM|||Anxiety Somatic, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.40|0.2689
70885668|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.134||0.211|TWO_SIDED|95.0|-0.44|0.1|||MMRM|||Anxiety Somatic, Hour 48 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.44|0.2110
70885669|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.135||0.5873|TWO_SIDED|95.0|-0.34|0.2|||MMRM|||Anxiety Somatic, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.34|0.5873
70885670|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.114||0.045|TWO_SIDED|95.0|-0.46|-0.01|||MMRM|||Anxiety Somatic, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.46|0.0450
70885671|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.152||0.0847|TWO_SIDED|95.0|-0.57|0.04|||MMRM|||Anxiety Somatic, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.57|0.0847
70885672|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.189||0.2522|TWO_SIDED|95.0|-0.16|0.6|||MMRM|||Anxiety Somatic, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.60|-0.16|0.2522
70885673|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.16||0.5026|TWO_SIDED|95.0|-0.43|0.21|||MMRM|||Anxiety Somatic, day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.43|0.5026
70885674|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.149||0.5911|TWO_SIDED|95.0|-0.38|0.22|||MMRM|||Anxiety Somatic, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.38|0.5911
70885675|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.122||0.58|TWO_SIDED|95.0|-0.18|0.31|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.18|0.5800
70885676|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.129||0.6754|TWO_SIDED|95.0|-0.31|0.2|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.31|0.6754
70885677|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.116||0.1006|TWO_SIDED|95.0|-0.04|0.42|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.42|-0.04|0.1006
70885678|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.12||0.3588|TWO_SIDED|95.0|-0.13|0.35|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.13|0.3588
70885679|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.109||0.5807|TWO_SIDED|95.0|-0.28|0.16|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.28|0.5807
70885680|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.112||0.4241|TWO_SIDED|95.0|-0.13|0.31|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.13|0.4241
70885681|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.115||0.7984|TWO_SIDED|95.0|-0.26|0.2|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.26|0.7984
70885682|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.122||0.8732|TWO_SIDED|95.0|-0.22|0.26|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.22|0.8732
70885683|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.107||0.8621|TWO_SIDED|95.0|-0.19|0.23|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.19|0.8621
70885684|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.126||0.1087|TWO_SIDED|95.0|-0.45|0.05|||MMRM|||Somatic Symptoms Gastrointestinal, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.45|0.1087
70885685|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.125||0.2153|TWO_SIDED|95.0|-0.41|0.09|||MMRM|||Somatic Symptoms Gastrointestinal, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.41|0.2153
70885686|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.145||0.1422|TWO_SIDED|95.0|-0.51|0.07|||MMRM|||Somatic Symptoms Gastrointestinal, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.51|0.1422
70885687|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.114||0.7211|TWO_SIDED|95.0|-0.19|0.27|||MMRM|||Somatic Symptoms Gastrointestinal, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.19|0.7211
70885688|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.103||0.8224|TWO_SIDED|95.0|-0.18|0.23|||MMRM|||Somatic Symptoms General, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.18|0.8224
70885689|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.126||0.6362|TWO_SIDED|95.0|-0.31|0.19|||MMRM|||Somatic Symptoms General, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.31|0.6362
70885690|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.123||0.6094|TWO_SIDED|95.0|-0.31|0.18|||MMRM|||Somatic Symptoms General, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.31|0.6094
70885691|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.123||0.0457|TWO_SIDED|95.0|-0.49|0.0|||MMRM|||Somatic Symptoms General, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.49|0.0457
70885692|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.5691|TWO_SIDED|95.0|-0.36|0.2|||MMRM|||Somatic Symptoms General, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.36|0.5691
70885693|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.13||0.2942|TWO_SIDED|95.0|-0.4|0.12|||MMRM|||Somatic Symptoms General, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.40|0.2942
70885694|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.136||0.5389|TWO_SIDED|95.0|-0.35|0.19|||MMRM|||Somatic Symptoms General, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.35|0.5389
70885695|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.141||0.4061|TWO_SIDED|95.0|-0.4|0.16|||MMRM|||Somatic Symptoms General, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.40|0.4061
70885696|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.153||0.099|TWO_SIDED|95.0|-0.56|0.05|||MMRM|||Somatic Symptoms General, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.56|0.0990
70885697|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.138||0.0108|TWO_SIDED|95.0|-0.63|-0.08|||MMRM|||Somatic Symptoms General, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.08|-0.63|0.0108
70885698|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.16||0.0889|TWO_SIDED|95.0|-0.59|0.04|||MMRM|||Somatic Symptoms General, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.59|0.0889
70885699|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.169||0.3721|TWO_SIDED|95.0|-0.18|0.49|||MMRM|||Somatic Symptoms General, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.49|-0.18|0.3721
70885700|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.141||0.5513|TWO_SIDED|95.0|-0.36|0.2|||MMRM|||Somatic Symptoms General, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.36|0.5513
70885701|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.067||0.0748|TWO_SIDED|95.0|-0.01|0.26|||MMRM|||Genital Symptoms, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.01|0.0748
70885702|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.087||0.3545|TWO_SIDED|95.0|-0.09|0.25|||MMRM|||Genital Symptoms, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.09|0.3545
70885703|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.094||0.6531|TWO_SIDED|95.0|-0.14|0.23|||MMRM|||Genital Symptoms, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.14|0.6531
70885704|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.115||0.752|TWO_SIDED|95.0|-0.26|0.19|||MMRM|||Genital Symptoms, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.26|0.7520
70885705|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.123||0.8861|TWO_SIDED|95.0|-0.26|0.23|||MMRM|||Genital Symptoms, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.26|0.8861
70885706|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.127||0.328|TWO_SIDED|95.0|-0.38|0.13|||MMRM|||Genital Symptoms, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.38|0.3280
70885707|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.128||0.1123|TWO_SIDED|95.0|-0.46|0.05|||MMRM|||Genital Symptoms, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.46|0.1123
70885708|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.116||0.2541|TWO_SIDED|95.0|-0.36|0.1|||MMRM|||Genital Symptoms, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.36|0.2541
70885709|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.143||0.011|TWO_SIDED|95.0|-0.66|-0.09|||MMRM|||Genital Symptoms, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-0.66|0.0110
70885710|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.158||0.772|TWO_SIDED|95.0|-0.36|0.27|||MMRM|||Genital Symptoms, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.36|0.7720
70885711|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.6311|TWO_SIDED|95.0|-0.52|0.32|||MMRM|||Genital Symptoms, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.52|0.6311
70885712|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.207||0.6877|TWO_SIDED|95.0|-0.5|0.33|||MMRM|||Genital Symptoms, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.33|-0.50|0.6877
70885713|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.186||0.2465|TWO_SIDED|95.0|-0.15|0.58|||MMRM|||Genital Symptoms, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.58|-0.15|0.2465
70885714|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.101||0.1279|TWO_SIDED|95.0|-0.36|0.05|||MMRM|||Hypochondriasis, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.36|0.1279
70885715|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.093||0.3946|TWO_SIDED|95.0|-0.26|0.1|||MMRM|||Hypochondriasis, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.26|0.3946
70885716|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.095||0.6694|TWO_SIDED|95.0|-0.23|0.15|||MMRM|||Hypochondriasis, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.23|0.6694
70885717|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.1113|TWO_SIDED|95.0|-0.36|0.04|||MMRM|||Hypochondriasis, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.36|0.1113
70885718|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.089||0.5811|TWO_SIDED|95.0|-0.13|0.23|||MMRM|||Hypochondriasis, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.13|0.5811
70885719|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.106||0.6794|TWO_SIDED|95.0|-0.25|0.17|||MMRM|||Hypochondriasis, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.25|0.6794
70885720|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.099||0.6031|TWO_SIDED|95.0|-0.14|0.25|||MMRM|||Hypochondriasis, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.14|0.6031
70885721|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.099||0.6673|TWO_SIDED|95.0|-0.24|0.15|||MMRM|||Hypochondriasis, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.24|0.6673
70885722|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.102||0.6472|TWO_SIDED|95.0|-0.25|0.16|||MMRM|||Hypochondriasis, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.25|0.6472
70885723|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.119||0.8654|TWO_SIDED|95.0|-0.26|0.22|||MMRM|||Hypochondriasis, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.26|0.8654
70885724|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.14||0.2101|TWO_SIDED|95.0|-0.48|0.11|||MMRM|||Hypochondriasis, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.48|0.2101
70885725|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.126||0.7128|TWO_SIDED|95.0|-0.3|0.21|||MMRM|||Hypochondriasis, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.30|0.7128
70885726|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.09||0.3297|TWO_SIDED|95.0|-0.27|0.09|||MMRM|||Hypochondriasis, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.27|0.3297
70885727|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.069||0.4493|TWO_SIDED|95.0|-0.08|0.19|||MMRM|||Loss of weight, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.08|0.4493
70885728|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.081||0.0717|TWO_SIDED|95.0|-0.01|0.31|||MMRM|||Loss of weight, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.01|0.0717
70885729|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.066||0.1054|TWO_SIDED|95.0|-0.02|0.24|||MMRM|||Loss of Weight, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.02|0.1054
70885730|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.088||0.0408|TWO_SIDED|95.0|0.01|0.36|||MMRM|||Loss of Weight, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.36|0.01|0.0408
70885731|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.088||0.0233|TWO_SIDED|95.0|0.03|0.38|||MMRM|||Loss of Weight, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.38|0.03|0.0233
70885732|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.088||0.361|TWO_SIDED|95.0|-0.09|0.26|||MMRM|||Loss of Weight, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.09|0.3610
70885733|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.1||0.2358|TWO_SIDED|95.0|-0.08|0.32|||MMRM|||Loss of Weight, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.08|0.2358
70885734|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.085||0.9492|TWO_SIDED|95.0|-0.16|0.17|||MMRM|||Loss of Weight, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.16|0.9492
70885735|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.102||0.4352|TWO_SIDED|95.0|-0.28|0.12|||MMRM|||Loss of Weight, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.28|0.4352
70885736|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.125||0.1176|TWO_SIDED|95.0|-0.05|0.44|||MMRM|||Loss of Weight, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.44|-0.05|0.1176
70885737|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.174||0.7812|TWO_SIDED|95.0|-0.3|0.4|||MMRM|||Loss of Weight, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.40|-0.30|0.7812
70885738|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.182||0.5085|TWO_SIDED|95.0|-0.48|0.24|||MMRM|||Loss of Weight, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.48|0.5085
70885739|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.156||0.8274|TWO_SIDED|95.0|-0.28|0.34|||MMRM|||Loss of Weight, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.34|-0.28|0.8274
70885740|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.045||0.3675|TWO_SIDED|95.0|-0.13|0.05|||MMRM|||Insight, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.13|0.3675
70885741|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.045||0.1818|TWO_SIDED|95.0|-0.15|0.03|||MMRM|||Insight, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.15|0.1818
70885742|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.045||0.0826|TWO_SIDED|95.0|-0.17|0.01|||MMRM|||Insight, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.17|0.0826
70885743|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.045||0.6436|TWO_SIDED|95.0|-0.11|0.07|||MMRM|||Insight, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.11|0.6436
70885744|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.045||0.1827|TWO_SIDED|95.0|-0.15|0.03|||MMRM|||Insight, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.15|0.1827
70885745|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.045||0.9859|TWO_SIDED|95.0|-0.09|0.09|||MMRM|||Insight, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.09|0.9859
70885746|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.045||0.6672|TWO_SIDED|95.0|-0.07|0.11|||MMRM|||Insight, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.07|0.6672
70885747|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.046||0.2031|TWO_SIDED|95.0|-0.03|0.15|||MMRM|||Insight, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.03|0.2031
70885748|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.045||0.6664|TWO_SIDED|95.0|-0.07|0.11|||MMRM|||Insight, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.07|0.6664
70885749|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.045||0.3417|TWO_SIDED|95.0|-0.13|0.05|||MMRM|||Insight, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.13|0.3417
70885750|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.051||0.6622|TWO_SIDED|95.0|-0.12|0.08|||MMRM|||Insight, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.12|0.6622
70885751|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.051||0.9087|TWO_SIDED|95.0|-0.11|0.09|||MMRM|||Insight, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.11|0.9087
70963573|NCT05105789|141432000|EQUIVALENCE|Concordance between the PCR test results will be evaluated by calculating the Kappa statistic which will be reported along with corresponding two-sided 95% confidence interval. The nonparametric bootstrap technique will be used to construct the confidence interval. A kappa statistic of \>0.95 will be considered as sufficient to define lollipop swab test non-inferior to the gold-standard PCR testing of nasal swabs.|Kappa Co-efficient|0.91|||||TWO_SIDED|95.0|0.78|1.0||||||Kappa statistics for Nasal Swab PCR vs Lollipop Swab PCR||1.00|0.78|
70885752|NCT02942017|141257300|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.046||0.8263|TWO_SIDED|95.0|-0.08|0.1|||MMRM|||Insight, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.08|0.8263
70885753|NCT02942017|141257301|SUPERIORITY||LS mean difference|-4.86|STANDARD_ERROR_OF_MEAN|1.612||0.0033|TWO_SIDED|95.0|-8.06|-1.66|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.66|-8.06|0.0033
70885754|NCT02942017|141257301|SUPERIORITY||LS mean difference|-3.56|STANDARD_ERROR_OF_MEAN|2.154||0.1017|TWO_SIDED|95.0|-7.84|0.72|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.72|-7.84|0.1017
70885755|NCT02942017|141257301|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|1.884||0.9845|TWO_SIDED|95.0|-3.72|3.79|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||3.79|-3.72|0.9845
70885756|NCT02942017|141257302|SUPERIORITY||Odds Ratio (OR)|5.0||||0.0005|TWO_SIDED|95.0|2.0|12.5|||GEE method|||Hour 60: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||12.5|2.0|0.0005
70885757|NCT02942017|141257302|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0478|TWO_SIDED|95.0|1.0|8.4|||GEE method|||Day 7: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||8.4|1.0|0.0478
70885758|NCT02942017|141257302|SUPERIORITY||Odds Ratio (OR)|1.5||||0.4399|TWO_SIDED|95.0|0.5|4.6|||GEE method|||Day 30: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||4.6|0.5|0.4399
70885759|NCT02942017|141257303|SUPERIORITY||LS Mean Difference|-1.17|STANDARD_ERROR_OF_MEAN|1.041||0.2636|TWO_SIDED|95.0|-3.24|0.9|||MMRM|||Change at Hour 60: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.90|-3.24|0.2636
70885760|NCT02942017|141257303|SUPERIORITY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|1.103||0.4897|TWO_SIDED|95.0|-2.96|1.43|||MMRM|||Change at Day 7: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.43|-2.96|0.4897
70885761|NCT02942017|141257303|SUPERIORITY||LS Mean Difference|-1.86|STANDARD_ERROR_OF_MEAN|1.227||0.1341|TWO_SIDED|95.0|-4.3|0.59|||MMRM|||Change at Day 14: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.59|-4.30|0.1341
70885762|NCT02942017|141257303|SUPERIORITY||LS Mean Difference|-1.95|STANDARD_ERROR_OF_MEAN|1.408||0.1691|TWO_SIDED|95.0|-4.76|0.85|||MMRM|||Change at Day 21: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.85|-4.76|0.1691
70885763|NCT02942017|141257303|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|1.149||0.7852|TWO_SIDED|95.0|-2.6|1.97|||MMRM|||Change at Day 30: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.97|-2.60|0.7852
70885764|NCT00457197|141257306|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4709|TWO_SIDED||||||ANCOVA|||Baseline drinks/day used as covariate.||||0.4709
70885765|NCT00457197|141257307|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1272|TWO_SIDED||||||ANCOVA|||Baseline percent heavy drinking days included as covariate.||||0.1272
70885766|NCT00457197|141257308|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9642|TWO_SIDED||||||ANCOVA|||Baseline GGT used as covariate.||||0.9642
70885767|NCT00457197|141257309|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7222|TWO_SIDED||||||ANCOVA|||Baseline AST used as covariate.||||0.7222
70885768|NCT00457197|141257310|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1412|TWO_SIDED||||||ANCOVA|||Baseline ALT used as covariate.||||0.1412
70885769|NCT00457197|141257311|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7071|TWO_SIDED||||||ANCOVA|||Baseline HRSD used as covariate.||||0.7071
70885770|NCT00457197|141257312|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2569|TWO_SIDED||||||ANCOVA|||Baseline IDS-SR used as a covariate.||||0.2569
70885771|NCT00457197|141257313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8814|TWO_SIDED||||||ANCOVA|||Baseline YMRS used as a covariate.||||0.8814
70885772|NCT00457197|141257314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2473|TWO_SIDED||||||ANCOVA|||Baseline PACS used as a covariate.||||0.2473
70885773|NCT06561217|141257335|NON_INFERIORITY|A predefined non-inferiority margin of 0.05 was used. The primary study was powered on a retrospective, paired, non-inferiority design to evaluate abstraction accuracy of elements commonly used to help screen patients for clinical trials.|Mean Difference (Final Values)|0.02|||<|0.001|ONE_SIDED|95.0|0.00007515||||Wilcoxon (Mann-Whitney)||The upper bound of the 95% confidence interval is Inf due to the test being one-sided. Alternative hypothesis: true median location shift is greater than -0.05|A Shapiro-Wilk test was used to assess normality of paired differences in chart-level accuracy (alpha = 0.05). A one-sided, paired Wilcoxon Rank Sum test (alpha = 0.05) was employed to test the primary null hypothesis of whether chart-level accuracy of the Human+AI arm for EHR chart abstraction was non-inferior to the chart-level accuracy of a Human-alone arm abstraction by at least 5% (i.e., noninferiority margin).|||0.00007515|<0.001
70885774|NCT06561217|141257335|SUPERIORITY|The primary study was powered on a retrospective, paired, superiority design to evaluate abstraction accuracy of elements commonly used to help screen patients for clinical trials.|Mean Difference (Final Values)|0.02||||0.002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||A Shapiro-Wilk test was used to assess normality of paired differences in chart-level accuracy (alpha = 0.05). A one-sided, paired Wilcoxon Rank Sum test (alpha = 0.05) was employed to test the null hypothesis of whether chart-level accuracy of the Human+AI arm for EHR chart abstraction was superior to the chart-level accuracy of a Human-alone arm abstraction.||||0.002
70885775|NCT06561217|141257336|EQUIVALENCE|Null hypothesis: True difference is equal to 0. Alternate hypothesis: true difference is not equal to 0|Median Difference (Final Values)|0.66||||0.513|TWO_SIDED|95.0|-1.25|2.55|||Wilcoxon (Mann-Whitney)|||A two-sided, paired Wilcoxon Rank Sum test (alpha = 0.05) was employed to test for difference between chart-level efficiency of the Human+AI arm and chart-level efficiency of the Human-alone arm abstraction.||2.55|-1.25|0.513
70885776|NCT04552587|141257347|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||We compared change from baseline to follow up in our single group of caregivers.||||0.23
70885777|NCT02741115|141257416|SUPERIORITY||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.377||0.092|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|ANCOVA fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline maximal VO2. LOCF imputation used.||It was estimated that a sample size of 198 participants per group would provide 90% power to detect a mean treatment group difference in change from baseline to Week 26 in maximal VO2 scores of 10% (ie, an improvement of 2.8 mL/kg/min in the udenafil group compared to 0 in the control group, assuming a Type I error of 0.05 and standard deviation of 7.235). A difference of 2.8, equivalent to a 10% increase from a baseline of 28 mL/kg/min, represents approximately 0.4 standard deviations.||||0.092
70885778|NCT02741115|141257417|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.014||0.024|TWO_SIDED|||||LS mean was the estimated treatment difference from the analytical model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline maximal VO2.||||||0.024
70885779|NCT02741115|141257418|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.591||0.591|TWO_SIDED||||||ANCOVA|||||||0.591
70963574|NCT05105789|141432001|NON_INFERIORITY|a non-inferiority margin of δ=5% and a sensitivity/specificity of PCR testing of 99%||||||0.201|||||||one-sample binomial test|||Sensitivity H0: Sens-0.99 ≤ 0.05 vs. HA: Sens-0.99 \> -0.05||||0.2010
70885780|NCT02741115|141257419|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.094||0.169|TWO_SIDED||||||ANCOVA|||||||0.169
70885781|NCT02741115|141257420|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Median Difference (Final Values)|0.78|STANDARD_ERROR_OF_MEAN|0.308||0.012|TWO_SIDED|||||LS mean was the estimated treatment mean difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group, with a continuous covariate of Baseline maximal VO2. LOCF imputation.||||||0.012
70885782|NCT02741115|141257421|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|1.46||0.029|TWO_SIDED|||||LS mean was the estimated treatment difference in the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group, with a continuous covariate of Baseline maximal VO2. LOCF imputation.||||||0.029
70885783|NCT02741115|141257422|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.321||0.011|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline maximal VO2. LOCF imputation.||||||0.011
70885784|NCT02741115|141257423|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.903||0.696|TWO_SIDED||||||ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline VO2. LOCF imputation.||||||0.696
70885785|NCT02741115|141257424|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|1.319||0.915|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline maximal VO2. LOCF imputation.||||||0.915
70885786|NCT02741115|141257425|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|1.363||0.891|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline maximal VO2. LOCF imputation.||LS mean differences between treatment groups were analyzed.||||0.891
70885787|NCT02741115|141257426|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|1.1||0.691|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group, with a continuous covariate of Baseline physical functioning (child reported)||||||0.691
70963575|NCT05105789|141432001|NON_INFERIORITY|non-inferiority margin of δ=5% and a sensitivity/specificity of PCR testing of 99%||||||0.0705|||||||one-sample binomial test|||Specificity H0: Spec-0.99 ≤ 0.05 vs. HA: Spec-0.99 \> -0.05||||0.0705
70885788|NCT02741115|141257427|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|1.544||0.985|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline physical functioning (parent reported).||||||0.985
70885789|NCT02741115|141257428|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|1.14|STANDARD_ERROR_OF_MEAN|1.039||0.273|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline psychosocial health summary score (child reported).||||||0.273
70885790|NCT02741115|141257429|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|1.327||0.966|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline psychosocial health summary score (parent reported).||||||0.966
70885791|NCT02741115|141257430|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|1.011||0.706|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline cardiac module scale (Treatment II).||||||0.706
70885792|NCT02741115|141257431|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|1.707||0.382|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline cardiac module scale (perceived physical appearance)||||||0.382
70885793|NCT02741115|141257432|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|1.91|STANDARD_ERROR_OF_MEAN|1.611||0.236|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline cardiac module scale (treatment anxiety).||||||0.236
70885794|NCT02741115|141257433|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-0.99|STANDARD_ERROR_OF_MEAN|1.622||0.543|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline cardiac module scale (cognitive problems).||||||0.543
70885795|NCT02741115|141257434|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-1.66|STANDARD_ERROR_OF_MEAN|1.78||0.352|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline cardiac module scale (communication problems).||||||0.352
70885796|NCT02741115|141257435|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|3.59|STANDARD_ERROR_OF_MEAN|5.684||0.533|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors of ventricular morphology and treatment group with a continuous covariate of Baseline total score (age 8-12, child reported).||||||0.533
70885797|NCT02741115|141257436|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|1.84|STANDARD_ERROR_OF_MEAN|4.057||0.654|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline total score (age 8-12, parent reported).||||||0.654
70885798|NCT02741115|141257437|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|1.069||0.963|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline total score (ages 13-18, child reported)||||||0.963
70885799|NCT02741115|141257438|SUPERIORITY|LS mean differences between treatment group were analyzed.|Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|1.171||0.246|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors of ventricular morphology and treatment group with a continuous covariate of Baseline total score (ages 13-18, parent reported).||||||0.246
70885800|NCT03548584|141257439|SUPERIORITY||LS Mean Difference|-5.32||||0.0026|TWO_SIDED|95.0|-8.77|-1.87||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||||-1.87|-8.77|0.0026
70885801|NCT03548584|141257440|SUPERIORITY||LS Mean Difference|-0.27||||0.0078|TWO_SIDED|95.0|-0.47|-0.07||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||||-0.07|-0.47|0.0078
70885802|NCT03548584|141257441|SUPERIORITY||LS Mean Difference|-1.95||||0.004|TWO_SIDED|95.0|-3.28|-0.63||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Aggressive Behavior||-0.63|-3.28|0.0040
70885803|NCT03548584|141257441|SUPERIORITY||LS Mean Difference|-1.41||||0.0296|TWO_SIDED|95.0|-2.68|-0.14||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Physically Nonaggressive Behavior||-0.14|-2.68|0.0296
70885804|NCT03548584|141257441|SUPERIORITY||LS Mean Difference|-1.24||||0.0113|TWO_SIDED|95.0|-2.21|-0.28||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Verbally Agitated Behavior||-0.28|-2.21|0.0113
70885805|NCT03548584|141257441|SUPERIORITY||LS Mean Difference|-0.36||||0.1941|TWO_SIDED|95.0|-0.9|0.18||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Hiding and Hoarding||0.18|-0.90|0.1941
70885806|NCT03548584|141257442|SUPERIORITY||LS Mean Difference|0.85||||0.4242|TWO_SIDED|95.0|-1.24|2.93||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change From Baseline at Week 2||2.93|-1.24|0.4242
70885807|NCT03548584|141257442|SUPERIORITY||LS Mean Difference|-1.14||||0.3665|TWO_SIDED|95.0|-3.63|1.34||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change From Baseline at Week 4||1.34|-3.63|0.3665
70885808|NCT03548584|141257442|SUPERIORITY||LS Mean Difference|-2.32||||0.1065|TWO_SIDED|95.0|-5.15|0.5||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 6||0.50|-5.15|0.1065
70885809|NCT03548584|141257442|SUPERIORITY||LS Mean Difference|-5.08||||0.0011|TWO_SIDED|95.0|-8.12|-2.05||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 8||-2.05|-8.12|0.0011
70885810|NCT03548584|141257442|SUPERIORITY||LS Mean Difference|-6.47|||<|0.0001|TWO_SIDED|95.0|-9.54|-3.4||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 10||-3.40|-9.54|<.0001
70885811|NCT03548584|141257442|SUPERIORITY||LS Mean Difference|-5.32||||0.0026|TWO_SIDED|95.0|-8.77|-1.87||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 12||-1.87|-8.77|0.0026
70885812|NCT03548584|141257443|SUPERIORITY||LS Mean Difference|0.05||||0.3048|TWO_SIDED|95.0|-0.05|0.16||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 2||0.16|-0.05|0.3048
70885813|NCT03548584|141257443|SUPERIORITY||LS Mean Difference|-0.03||||0.7058|TWO_SIDED|95.0|-0.17|0.12||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 4||0.12|-0.17|0.7058
70885814|NCT03548584|141257443|SUPERIORITY||LS Mean Difference|-0.06||||0.4516|TWO_SIDED|95.0|-0.23|0.1||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 6||0.10|-0.23|0.4516
70885815|NCT03548584|141257443|SUPERIORITY||LS Mean Difference|-0.27||||0.0052|TWO_SIDED|95.0|-0.46|-0.08||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 8||-0.08|-0.46|0.0052
70885816|NCT03548584|141257443|SUPERIORITY||LS Mean Difference|-0.27||||0.006|TWO_SIDED|95.0|-0.47|-0.08||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 10||-0.08|-0.47|0.0060
70885817|NCT03548584|141257443|SUPERIORITY||LS Mean Difference|-0.27||||0.0078|TWO_SIDED|95.0|-0.47|-0.07||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 12||-0.07|-0.47|0.0078
70885818|NCT03548584|141257444|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.1975|TWO_SIDED|95.0|-0.05|0.26|||Cochran-Mantel-Haenszel|||Week 2||0.26|-0.05|0.1975
70885819|NCT03548584|141257444|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.0084|TWO_SIDED|95.0|-0.44|-0.06|||Cochran-Mantel-Haenszel|||Week 4||-0.06|-0.44|0.0084
70885820|NCT03548584|141257444|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.0101|TWO_SIDED|95.0|-0.46|-0.06|||Cochran-Mantel-Haenszel|||Week 6||-0.06|-0.46|0.0101
70885821|NCT03548584|141257444|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.0008|TWO_SIDED|95.0|-0.59|-0.15|||Cochran-Mantel-Haenszel|||Week 8||-0.15|-0.59|0.0008
70885822|NCT03548584|141257444|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.0023|TWO_SIDED|95.0|-0.55|-0.12|||Cochran-Mantel-Haenszel|||Week 10||-0.12|-0.55|0.0023
70885823|NCT03548584|141257444|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.007|TWO_SIDED|95.0|-0.57|-0.09|||Cochran-Mantel-Haenszel|||Week 12||-0.09|-0.57|0.0070
70885824|NCT03548584|141257445|SUPERIORITY||Ratio of Response Rate|1.1||||0.729|TWO_SIDED|95.0|0.64|1.91|||Cochran-Mantel-Haenszel|||\>/= 20%: Week 2||1.91|0.64|0.7290
70885825|NCT03548584|141257445|SUPERIORITY||Ratio of Response Rate|1.09||||0.6196|TWO_SIDED|95.0|0.78|1.52|||Cochran-Mantel-Haenszel|||\>/=20%: Week 4||1.52|0.78|0.6196
70885826|NCT03548584|141257445|SUPERIORITY||Ratio of Response Rate|1.16||||0.2718|TWO_SIDED|95.0|0.88|1.53|||Cochran-Mantel-Haenszel|||\>/=20%: Week 6||1.53|0.88|0.2718
70885827|NCT03548584|141257445|SUPERIORITY||Ratio of Response Rate|1.52||||0.0004|TWO_SIDED|95.0|1.19|1.93|||Cochran-Mantel-Haenszel|||\>/=20%: Week 8||1.93|1.19|0.0004
70885828|NCT03548584|141257445|SUPERIORITY||Ratio of Response Rate|1.42||||0.0006|TWO_SIDED|95.0|1.15|1.76|||Cochran-Mantel-Haenszel|||\>/=20%: Week 10||1.76|1.15|0.0006
70885829|NCT03548584|141257445|SUPERIORITY||Ratio of Response Rate|1.41||||0.0004|TWO_SIDED|95.0|1.15|1.72|||Cochran-Mantel-Haenszel|||\>/=20%: Week 12||1.72|1.15|0.0004
70885830|NCT03548584|141257445|SUPERIORITY||Ratio of Response Rate|1.22||||0.7211|TWO_SIDED|95.0|0.39|3.85|||Cochran-Mantel-Haenszel|||\>/=30%: Week 2||3.85|0.39|0.7211
70885831|NCT03548584|141257445|SUPERIORITY||Ratio of Response Rate|1.11||||0.7606|TWO_SIDED|95.0|0.57|2.14|||Cochran-Mantel-Haenszel|||\>/=30%: Week 4||2.14|0.57|0.7606
70885832|NCT03548584|141257445|SUPERIORITY||Ratio of Response Rate|1.12||||0.5902|TWO_SIDED|95.0|0.74|1.68|||Cochran-Mantel-Haenszel|||\>/=30%: Week 6||1.68|0.74|0.5902
70885833|NCT03548584|141257445|SUPERIORITY||Ratio of Response Rate|1.7||||0.0054|TWO_SIDED|95.0|1.14|2.54|||Cochran-Mantel-Haenszel|||\>/=30%: Week 8||2.54|1.14|0.0054
70885834|NCT03548584|141257445|SUPERIORITY||Ratio of Response Rate|1.59||||0.0066|TWO_SIDED|95.0|1.11|2.26|||Cochran-Mantel-Haenszel|||\>/=30%: Week 10||2.26|1.11|0.0066
70885835|NCT03548584|141257445|SUPERIORITY||Ratio of Response Rate|1.62||||0.0017|TWO_SIDED|95.0|1.18|2.23|||Cochran-Mantel-Haenszel|||\>/=30%: Week 12||2.23|1.18|0.0017
70885836|NCT03548584|141257445|SUPERIORITY||Ratio of Response Rate|1.11||||0.9074|TWO_SIDED|95.0|0.2|5.97|||Cochran-Mantel-Haenszel|||\>/=40%: Week 2||5.97|0.20|0.9074
70885837|NCT03548584|141257445|SUPERIORITY||Ratio of Response Rate|0.98||||0.9625|TWO_SIDED|95.0|0.36|2.64|||Cochran-Mantel-Haenszel|||\>/=40%: Week 4||2.64|0.36|0.9625
70885838|NCT03548584|141257445|SUPERIORITY||Ratio of Response Rate|1.26||||0.512|TWO_SIDED|95.0|0.63|2.53|||Cochran-Mantel-Haenszel|||\>/=40%: Week 6||2.53|0.63|0.5120
70885839|NCT03548584|141257445|SUPERIORITY||Ratio of Response Rate|1.98||||0.0244|TWO_SIDED|95.0|1.03|3.79|||Cochran-Mantel-Haenszel|||\>/=40%: Week 8||3.79|1.03|0.0244
70885840|NCT03548584|141257445|SUPERIORITY||Ratio of Response Rate|1.86||||0.0161|TWO_SIDED|95.0|1.08|3.18|||Cochran-Mantel-Haenszel|||\>/=40%: Week 10||3.18|1.08|0.0161
70885841|NCT03548584|141257445|SUPERIORITY||Ratio of Response Rate|1.62||||0.0347|TWO_SIDED|95.0|1.0|2.61|||Cochran-Mantel-Haenszel|||\>/=40%: Week 12||2.61|1.00|0.0347
70885842|NCT03548584|141257446|SUPERIORITY||Ratio of Response Rate|0.64||||0.1503|TWO_SIDED|95.0|0.35|1.16|||Cochran-Mantel-Haenszel|||Week 2||1.16|0.35|0.1503
70885843|NCT03548584|141257446|SUPERIORITY||Ratio of Response Rate|1.07||||0.7559|TWO_SIDED|95.0|0.69|1.67|||Cochran-Mantel-Haenszel|||Week 4||1.67|0.69|0.7559
70885844|NCT03548584|141257446|SUPERIORITY||Ratio of Response Rate|1.23||||0.2246|TWO_SIDED|95.0|0.88|1.72|||Cochran-Mantel-Haenszel|||Week 6||1.72|0.88|0.2246
70885845|NCT03548584|141257446|SUPERIORITY||Ratio of Response Rate|1.38||||0.0276|TWO_SIDED|95.0|1.02|1.87|||Cochran-Mantel-Haenszel|||Week 8||1.87|1.02|0.0276
70885846|NCT03548584|141257446|SUPERIORITY||Ratio of Response Rate|1.46||||0.0031|TWO_SIDED|95.0|1.12|1.89|||Cochran-Mantel-Haenszel|||Week 10||1.89|1.12|0.0031
70885847|NCT03548584|141257446|SUPERIORITY||Ratio of Response Rate|1.47||||0.0017|TWO_SIDED|95.0|1.14|1.89|||Cochran-Mantel-Haenszel|||Week 12||1.89|1.14|0.0017
70885848|NCT03548584|141257447|SUPERIORITY||Ratio of Response Rate|1.1||||0.8549|TWO_SIDED|95.0|0.4|3.03|||Cochran-Mantel-Haenszel|||Week 2||3.03|0.40|0.8549
70885849|NCT03548584|141257447|SUPERIORITY||Ratio of Response Rate|1.95||||0.0093|TWO_SIDED|95.0|1.14|3.32|||Cochran-Mantel-Haenszel|||Week 4||3.32|1.14|0.0093
70885850|NCT03548584|141257447|SUPERIORITY||Ratio of Response Rate|1.56||||0.0083|TWO_SIDED|95.0|1.1|2.22|||Cochran-Mantel-Haenszel|||Week 6||2.22|1.10|0.0083
70885851|NCT03548584|141257447|SUPERIORITY||Ratio of Response Rate|1.85|||<|0.0001|TWO_SIDED|95.0|1.32|2.58|||Cochran-Mantel-Haenszel|||Week 8||2.58|1.32|<.0001
70885852|NCT03548584|141257447|SUPERIORITY||Ratio of Response Rate|1.57||||0.0005|TWO_SIDED|95.0|1.18|2.09|||Cochran-Mantel-Haenszel|||Week 10||2.09|1.18|0.0005
70885853|NCT03548584|141257447|SUPERIORITY||Ratio of Response Rate|1.32||||0.016|TWO_SIDED|95.0|1.03|1.69|||Cochran-Mantel-Haenszel|||Week 12||1.69|1.03|0.0160
70885854|NCT01101841|141257448|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Week 4 frequency|Rank transformed ANCOVA|||||||<0.0001
70885855|NCT01101841|141257448|SUPERIORITY_OR_OTHER|||||||0.0001||||||Week 12 frequency|Rank transformed ANCOVA|||||||0.0001
70885856|NCT01101841|141257449|SUPERIORITY_OR_OTHER|||||||0.0066||||||Week 24 persistence of effect|Logit model|||||||0.0066
70885857|NCT01101841|141257464|SUPERIORITY_OR_OTHER|||||||0.0368||||||Week 4 severity|Rank transformed ANCOVA|||||||0.0368
70885858|NCT01101841|141257464|SUPERIORITY_OR_OTHER|||||||0.0064||||||Week 12 severity|Rank transformed ANCOVA|||||||0.0064
70885859|NCT03633396|141257481|OTHER||Least Squares (LS) Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.98||0.944|TWO_SIDED|95.0|-4.05|3.77|||Mixed-model Repeated Measures (MMRM)|MMRM including fixed effects of treatment, history of plaque psoriasis, visit, treatment by visit interaction, and Baseline PPPASI score as covariate.|Least-squares mean difference = Imsidolimab - Placebo|The change from Baseline in PPPASI at Week 16 was analyzed using a a general linear mixed model for repeated measures (MMRM). The model included fixed effects for treatment, history of plaque psoriasis (Yes/No), visit, treatment by visit interaction, and Baseline PPPASI score as covariate.||3.77|-4.05|0.944
70885860|NCT03633396|141257483|OTHER||Odds Ratio (OR)|0.879|||||TWO_SIDED|95.0|0.288|2.686|||||Odds ratio from a logistic regression model including treatment as fixed effect, history of plaque psoriasis and Baseline PPPASI score as covariates and using multiple imputation for missing data.|||2.686|0.288|
70885861|NCT03633396|141257484|OTHER||Odds Ratio (OR)|2.6|||||TWO_SIDED|95.0|0.5|13.9|||||Odds ratio from a logistic regression model including treatment as fixed effect, history of plaque psoriasis and Baseline PPPIGA score as covariates and using multiple imputation for missing data.|||13.9|0.5|
70885862|NCT05478174|141257503|NON_INFERIORITY|Non inferiority margin is -8%|Risk Difference (RD)|-0.0078|||<|0.001|TWO_SIDED|95.0|-0.0411|0.0255||P-Value for non inferiority test|Farrington-Manning method|||||0.0255|-0.0411|<0.001
70885863|NCT05478174|141257504|SUPERIORITY||Risk Difference (RD)|-0.0716||||0.171|TWO_SIDED|95.0|-0.1742|0.031|||Cochran-Mantel-Haenszel|||||0.0310|-0.1742|0.171
70885864|NCT05478174|141257505|SUPERIORITY||Mean Difference (Final Values)|-1.76|STANDARD_ERROR_OF_MEAN|0.231|<|0.001|TWO_SIDED|95.0|-2.22|-1.31|||ANOVA|||||-1.31|-2.22|<0.001
70885865|NCT00326612|141257552|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||||95.0||||||||||||
70885866|NCT00326612|141257553|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||||95.0|0.2|3.9||||||||3.9|0.2|
70885867|NCT00326612|141257554|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||||95.0|0.4|2.7||||||||2.7|0.4|
70885868|NCT00326612|141257555|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||||95.0|0.2|8.2||||||||8.2|0.2|
70885869|NCT00326612|141257556|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||||95.0|0.0|67.3||||||||67.3|0.0|
70885870|NCT00326612|141257557|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.6||||||95.0|0.2|140.7||||||||140.7|0.2|
70885871|NCT00548808|141257558|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 0.4% for HbA1c was used.|Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.11||0.716|TWO_SIDED|95.0|-0.25|0.17|||ANCOVA|ANCOVA Model: Change in HbA1c = Treatment + Baseline + Country + Sulfonylurea use (Type III sums of squares).|Least Squares Mean Difference = Insulin Lispro LM minus Insulin Glargine.|||0.17|-0.25|0.716
70885872|NCT00548808|141257559|SUPERIORITY_OR_OTHER|||||||0.279||95.0||||P-value for 16 Week Change from Baseline.|Mixed Models Analysis|Mixed Model Analysis: Change in HbA1c = Treatment + Baseline + Country + Sulfonylurea use + Visit + Treatment\*Visit (Type 3 sums of squares).||||||0.279
70885873|NCT00548808|141257559|SUPERIORITY_OR_OTHER|||||||0.846||95.0||||P-value for 32 Week Change from Baseline.|Mixed Models Analysis|Mixed Model Analysis: Change in HbA1c = Treatment + Baseline + Country + Sulfonylurea use + Visit + Treatment\*Visit (Type 3 sums of squares).||||||0.846
70885874|NCT00548808|141257559|SUPERIORITY_OR_OTHER|||||||0.741||95.0||||P-value for 48 Week Change from Baseline.|Mixed Models Analysis|Mixed Model Analysis: Change in HbA1c = Treatment + Baseline + Country + Sulfonylurea use + Visit + Treatment\*Visit (Type 3 sums of squares).||||||0.741
70885875|NCT00548808|141257560|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.465|TWO_SIDED|95.0|0.41|1.5||P-value for patients achieving HbA1c \<6.5% at 16 weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit\*treatment.||||1.50|0.41|0.465
70885876|NCT00548808|141257560|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.365|TWO_SIDED|95.0|0.51|1.28||P-value for Patients Achieving HbA1c \<7% at 16 Weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit\*treatment.||||1.28|0.51|0.365
70885877|NCT00548808|141257560|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.683|TWO_SIDED|95.0|0.65|1.95||P-value for patients achieving HbA1c \<6.5% at 32 weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit\*treatment.||||1.95|0.65|0.683
70885878|NCT00548808|141257560|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.81|TWO_SIDED|95.0|0.68|1.64||P-value for patients achieving HbA1c \<7% at 32 weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit\*treatment.||||1.64|0.68|0.810
70885879|NCT00548808|141257560|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.555|TWO_SIDED|95.0|0.69|2.01||P-value for patients achieving HbA1c \<6.5% at 48 weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit\*treatment.||||2.01|0.69|0.555
70885880|NCT00548808|141257560|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.829|TWO_SIDED|95.0|0.67|1.64||P-value for patients achieving HbA1c \<7% at 48 weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit\*treatment.||||1.64|0.67|0.829
70885881|NCT00548808|141257562|SUPERIORITY_OR_OTHER|||||||0.604||95.0||||P-value for Week 16 Change from Baseline|Mixed Models Analysis|Mixed Model Analysis: Change in Blood Glucose = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use + Visit + Treatment\*Visit||||||0.604
70885882|NCT00548808|141257562|SUPERIORITY_OR_OTHER|||||||0.814||95.0||||P-value for Week 32 Change from Baseline.|Mixed Models Analysis|Mixed Model Analysis: Change in Blood Glucose = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use + Visit + Treatment\*Visit||||||0.814
70885883|NCT00548808|141257562|SUPERIORITY_OR_OTHER|||||||0.582||95.0||||P-value for 48 Week Change from Baseline.|Mixed Models Analysis|Mixed Model Analysis: Change in Blood Glucose = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use + Visit + Treatment\*Visit||||||0.582
70885884|NCT00548808|141257565|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.08||0.162|TWO_SIDED|95.0|-0.26|0.04||P-value for Cholesterol.|ANCOVA|ANCOVA model: Lab Result = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use (Type III sums of squares).|Least Squares Mean Difference = Insulin Lispro LM minus Insulin Glargine.|||0.04|-0.26|0.162
70885885|NCT00548808|141257565|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.09||0.165|TWO_SIDED|95.0|-0.3|0.05||P-value for Triglycerides.|ANCOVA|ANCOVA model: Lab Result = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use (Type III sums of squares).|Least Squares Mean Difference = Insulin Lispro LM minus Insulin Glargine.|||0.05|-0.30|0.165
70885886|NCT00548808|141257565|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.51|TWO_SIDED|95.0|-0.18|0.09||P-value for Low Density Lipoprotein.|ANCOVA|ANCOVA model: Lab Result = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use (Type III sums of squares).|Least Squares Mean Difference = Insulin Lispro LM minus Insulin Glargine.|||0.09|-0.18|0.510
70885887|NCT00548808|141257565|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.382|TWO_SIDED|95.0|-0.02|0.06||P-value for High Density Lipoprotein.|ANCOVA|ANCOVA model: Lab Result = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use (Type III sums of squares).|Least Squares Mean Difference = Insulin Lispro LM minus Insulin Glargine.|||0.06|-0.02|0.382
70885888|NCT00749775|141257569|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean systolic blood pressure at 4 weeks does not differ from that at baseline.||||<0.001
70885889|NCT00749775|141257569|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean systolic blood pressure at 8 weeks does not differ from that at baseline.||||<0.001
70885890|NCT00749775|141257569|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean systolic blood pressure at 12 weeks does not differ from that at baseline.||||<0.001
70885891|NCT00749775|141257569|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean systolic blood pressure at last evaluation date does not differ from that at baseline.||||<0.001
70885892|NCT00749775|141257570|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean diastolic blood pressure at 4 weeks does not differ from that at baseline.||||<0.001
70885893|NCT00749775|141257570|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean diastolic blood pressure at 8 weeks does not differ from that at baseline.||||<0.001
70885894|NCT00749775|141257570|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean diastolic blood pressure at 12 weeks does not differ from that at baseline.||||<0.001
70885895|NCT00749775|141257570|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean diastolic blood pressure at last evaluation date does not differ from that at baseline.||||<0.001
70885896|NCT02583256|141257614|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.1|1.3||||||Comparison performed for strain A/H1N1.||1.3|1.1|
70885897|NCT02583256|141257614|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|0.93|||||TWO_SIDED|95.0|0.9|1.0||||||Comparison performed for strain A/H3N2.||1.0|0.9|
70885898|NCT02583256|141257614|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.1|1.3||||||Comparison performed for strain B/Yamagata.||1.3|1.1|
70885899|NCT02583256|141257614|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.18|||||TWO_SIDED|95.0|1.1|1.3||||||Comparison performed for strain B/Victoria.||1.3|1.1|
70885900|NCT02583256|141257615|SUPERIORITY|Superiority criterion for the GMT ratio: Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should exceed 1.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.1|1.3||||||Comparison performed for strain A/H1N1.||1.3|1.1|
70885901|NCT02583256|141257615|SUPERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should exceed 1.|GMT ratio|0.93|||||TWO_SIDED|95.0|0.9|1.0||||||Comparison performed for strain A/H3N2.||1.0|0.9|
70885902|NCT02583256|141257615|SUPERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should exceed 1.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.1|1.3||||||Comparison performed for strain B/Yamagata.||1.3|1.1|
70885903|NCT02583256|141257615|SUPERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should exceed 1.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.1|1.3||||||Comparison performed for strain B/Victoria.||1.3|1.1|
70885904|NCT02583256|141257616|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.39|||||TWO_SIDED|95.0|1.28|1.51||||||Comparison performed for strain A/H1N1.||1.51|1.28|
70885905|NCT02583256|141257616|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.06|||||TWO_SIDED|95.0|0.99|1.14||||||Comparison performed for strain A/H3N2||1.14|0.99|
70885906|NCT02583256|141257616|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.42|||||TWO_SIDED|95.0|1.27|1.58||||||Comparison performed for strain B/Yamagata.||1.58|1.27|
70885907|NCT02583256|141257616|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.36|||||TWO_SIDED|95.0|1.22|1.51||||||Comparison performed for strain B/Victoria.||1.51|1.22|
70885908|NCT02583256|141257617|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.07|1.32||||||Comparison performed for strain A/H1N1.||1.32|1.07|
70885909|NCT02583256|141257617|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|0.99|||||TWO_SIDED|95.0|0.9|1.09||||||Comparison performed for strain A/H3N2.||1.09|0.90|
70885910|NCT02583256|141257617|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.12|||||TWO_SIDED|95.0|1.01|1.25||||||Comparison performed for strain B/Yamagata.||1.25|1.01|
70885911|NCT02583256|141257617|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.11|||||TWO_SIDED|95.0|0.98|1.27||||||Comparison performed for strain B/Victoria.||1.27|0.98|
70885912|NCT02583256|141257617|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.4|||||TWO_SIDED|95.0|1.3|1.5||||||Comparison performed for strain A/H1N1.||1.5|1.3|
70885913|NCT02583256|141257617|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.01|||||TWO_SIDED|95.0|0.9|1.1||||||Comparison performed for strain A/H3N2.||1.1|0.9|
70885914|NCT02583256|141257617|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.3|||||TWO_SIDED|95.0|1.2|1.4||||||Comparison performed for strain B/Yamagata.||1.4|1.2|
70885915|NCT02583256|141257617|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.32|||||TWO_SIDED|95.0|1.2|1.5||||||Comparison performed for strain B/Victoria.||1.5|1.2|
70885916|NCT02583256|141257618|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|1.8|||||TWO_SIDED|95.0|-4.9|8.6||||||Comparison performed for strain A/H1N1.||8.6|-4.9|
70885917|NCT02583256|141257618|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|0.9|||||TWO_SIDED|95.0|-5.6|7.3||||||Comparison performed for strain A/H3N2.||7.3|-5.6|
70885918|NCT02583256|141257618|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|4.3|||||TWO_SIDED|95.0|-1.8|10.4||||||Comparison performed for strain B/Yamagata.||10.4|-1.8|
70885919|NCT02583256|141257618|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|2.6|||||TWO_SIDED|95.0|-3.3|8.5||||||Comparison performed for strain B/Victoria.||8.5|-3.3|
70885920|NCT02583256|141257618|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|9.67|||||TWO_SIDED|95.0|3.11|16.17||||||Comparison performed for strain A/H1N1.||16.17|3.11|
70885921|NCT02583256|141257618|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|-3.95|||||TWO_SIDED|95.0|-10.02|2.15||||||Comparison performed for strain A/H3N2.||2.15|-10.02|
70885922|NCT02583256|141257618|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|12.95|||||TWO_SIDED|95.0|6.73|19.12||||||Comparison performed for strain B/Yamagata.||19.12|6.73|
70885923|NCT02583256|141257618|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|8.36|||||TWO_SIDED|95.0|2.17|14.54||||||Comparison performed for strain B/Victoria.||14.54|2.17|
70885924|NCT04537806|141257636|SUPERIORITY||Proc Genmod|0.0||||1|TWO_SIDED|95.0|-31.8|31.8|||Chi-squared||Estimates for treatment, and the corresponding 95% confidence interval (CI) were estimated using Proc Genmod method, with treatment as a factor and age groups as a covariate variable.|||31.8|-31.8|1.0000
70885925|NCT05459129|141257639|SUPERIORITY||Difference in pCR Rates|33.33|||||TWO_SIDED|95.0|-33.23|99.9||||||||99.90|-33.23|
70885926|NCT05459129|141257640|SUPERIORITY||Difference in pRR|33.33|||||TWO_SIDED|95.0|-21.05|87.72||||||||87.72|-21.05|
70885927|NCT05459129|141257641|SUPERIORITY||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.11|3.91|||||HR was estimated by Cox regression. Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made in terms of median EFS per arm or HR between the arms.|||3.91|0.11|
70885928|NCT05459129|141257642|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.13|6.43|||||HR was estimated by Cox regression. Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made in terms of media RFS per arm or HR between the arms.|||6.43|0.13|
70885929|NCT05459129|141257644|SUPERIORITY||Difference in ORR|16.67|||||TWO_SIDED|95.0|-54.99|88.32||||||||88.32|-54.99|
70885930|NCT05459129|141257645|SUPERIORITY||Difference in Event Free Rate|16.67|||||TWO_SIDED|95.0|-31.42|64.75|||||Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made.|3 Months Analysis||64.75|-31.42|
70885931|NCT05459129|141257645|SUPERIORITY||Difference in Event Free Rate|0.0|||||TWO_SIDED|95.0|-53.34|53.34|||||Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made.|6 Months Analysis||53.34|-53.34|
70885932|NCT05459129|141257646|SUPERIORITY||Difference in Event Free Rate|-13.33|||||TWO_SIDED|95.0|-64.83|38.16|||||Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made|3 Months Analysis||38.16|-64.83|
70885933|NCT05459129|141257646|SUPERIORITY||Difference in Event Free Rate|6.67|||||TWO_SIDED|95.0|-50.49|63.82|||||Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made|6 Months Analysis||63.82|-50.49|
70885934|NCT05358821|141257683|SUPERIORITY||Mean Difference|3.3657|STANDARD_ERROR_OF_MEAN|0.2539|<|0.0001|TWO_SIDED|95.0|2.8566|3.8749|||T-test||Difference was calculated as HP - HD.|||3.8749|2.8566|<0.0001
70885935|NCT02504372|141257687|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.68|0.96|||||HR and 95% confidence interval (95%CI) were based on multivariate Cox regression model with treatment adjusted by stage, PD-L1 status, adjuvant chemotherapy, region, histology, and smoking status.|||0.96|0.68|
70885936|NCT02504372|141257688|OTHER||Hazard Ratio (HR)|0.83||||0.13499|TWO_SIDED|95.0|0.59|1.16|||Regression, Cox|One-sided p-value was based on the permutation test with multivariate Cox regression model.|HR and 95% confidence interval (95%CI) were based on multivariate Cox regression model with treatment adjusted by stage, PD-L1 status, adjuvant chemotherapy, region, histology, and smoking status.|||1.16|0.59|0.13499
70885937|NCT02504372|141257689|OTHER||Hazard Ratio (HR)|0.78||||0.01327|TWO_SIDED|95.0|0.62|0.97|||Regression, Cox|One-sided p-value was based on the permutation test with multivariate Cox regression model.|HR and 95% confidence interval (95%CI) were based on multivariate Cox regression model with treatment adjusted by stage, PD-L1 status, adjuvant chemotherapy, region, histology, and smoking status.|||0.97|0.62|0.01327
70885938|NCT02504372|141257696|OTHER||Hazard Ratio (HR)|0.76||||0.00143|TWO_SIDED|95.0|0.63|0.91|||Regression, Cox|One-sided p-value was based on the permutation test with multivariate Cox regression model.|HR and 95% confidence interval (95%CI) were based on multivariate Cox regression model with treatment adjusted by stage, PD-L1 status, adjuvant chemotherapy, region, histology, and smoking status.|||0.91|0.63|0.00143
70885939|NCT03901963|141257697|SUPERIORITY||Odds Ratio (OR)|4.51|||<|0.0001|TWO_SIDED|95.0|2.37|8.57||Tested at 2-sided 0.05 significance level through stratified CMH method. Stratification factor included baseline cytogenetic risk per investigator'|stratified Cochran-Mantel-Haenszel (CMH)||Odds ratio and 95% CI were estimated by Mantel-Haenszel method. Stratification factor included baseline cytogenetic risk per investigator's assessment (high risk versus standard/unknown risk) as used for randomization of the study.|||8.57|2.37|<0.0001
70885940|NCT05429203|141257716|OTHER|||||||0.8||||||The a priori threshold for statistical significance was \<0.05.|Chi-squared|||||||0.8
70885941|NCT05429203|141257717|OTHER|||||||1||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||1
70885942|NCT05429203|141257718|OTHER|||||||0.7||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.7
70885943|NCT05429203|141257719|OTHER|||||||0.4||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.4
70885944|NCT05429203|141257720|OTHER|||||||0.8||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.8
70885945|NCT05429203|141257721|OTHER|||||||0.8||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.8
70885946|NCT05429203|141257722|OTHER|||||||0.7||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.7
70885947|NCT05429203|141257723|OTHER|||||||0.6||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.6
70885948|NCT05429203|141257724|OTHER|||||||0.5||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.5
70885949|NCT05429203|141257725|OTHER|||||||0.9||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.9
70885950|NCT05429203|141257726|OTHER|||||||0.8||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.8
70885951|NCT05429203|141257727|OTHER|||||||0.9||||||the a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.9
70885952|NCT05944250|141257764|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||||||0.21
70885953|NCT05944250|141257768|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Wounds that reach \>50% healing from baseline per investigator assessment at Month 1||||1
70885954|NCT05944250|141257768|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Wounds that reach \>50% healing from baseline per investigator assessment at Month 2||||1
70885955|NCT05944250|141257768|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Wounds that reach \>50% healing from baseline per investigator assessment at Month 3||||1
70885956|NCT05944250|141257768|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||Wounds that reach \>50% healing from baseline per investigator assessment at Month 4||||0.15
70885957|NCT05944250|141257769|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Wounds that reach \>70% healing from baseline per investigator assessment at Month 1||||1
70885958|NCT05944250|141257769|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Wounds that reach \>70% healing from baseline per investigator assessment at Month 2||||1
70885959|NCT05944250|141257769|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||Wounds that reach \>70% healing from baseline per investigator assessment at Month 3||||0.59
70885960|NCT05944250|141257769|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||Wounds that reach \>70% healing from baseline per investigator assessment at Month 4||||0.09
70885961|NCT05619692|141257791|SUPERIORITY||Difference in LS Means|1.5|STANDARD_ERROR_OF_MEAN|1.11||0.1642|TWO_SIDED|95.0|-0.64|3.73||The p-value was obtained using MMRM model which included treatment, visit, treatment-by-visit interaction as categorical covariates, and WAIS-IV at baseline as continuous covariates.|MRMM||Difference was calculated as SAGE-718 - placebo.|||3.73|-0.64|0.1642
70885962|NCT01946204|141257795|SUPERIORITY||Hazard Ratio (HR)|0.271|||<|0.0001|TWO_SIDED|95.0|0.219|0.335|||Log Rank|||Statistical Analysis for TTM by BICR (US Regulatory)||0.335|0.219|<0.0001
70885963|NCT01946204|141257795|SUPERIORITY||Hazard Ratio (HR)|0.279|||<|0.0001|TWO_SIDED|95.0|0.227|0.342|||Log Rank|||Statistical Analysis for TTM by BICR (Ex-US Regulatory)||0.342|0.227|<0.0001
70885964|NCT01946204|141257796|SUPERIORITY||Hazard Ratio (HR)|0.291|||<|0.0001|TWO_SIDED|95.0|0.238|0.356|||Log Rank|||Statistical Analysis for PFS by BICR (US Regulatory)||0.356|0.238|<0.0001
70885965|NCT01946204|141257796|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.247|0.364|||Log Rank|||Statistical Analysis for PFS by BICR (EX-US Regulatory)||0.364|0.247|<0.0001
70885966|NCT01946204|141257797|SUPERIORITY||Hazard Ratio (HR)|0.447|||<|0.0001|TWO_SIDED|95.0|0.315|0.634|||Log Rank|||Statistical Analysis for Time to Symptomatic Progression||0.634|0.315|<0.0001
70885967|NCT01946204|141257800|SUPERIORITY||Hazard Ratio (HR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.227|0.346|||Log Rank|||Statistical Analysis for MFS by BICR (US Regulatory)||0.346|0.227|<0.0001
70885968|NCT01946204|141257800|SUPERIORITY||Hazard Ratio (HR)|0.297|||<|0.0001|TWO_SIDED|95.0|0.244|0.362|||Log Rank|||Statistical Analysis for MFS by BICR (Ex-US Regulatory)||0.362|0.244|<0.0001
70885969|NCT03466411|141257801|SUPERIORITY||Least Square (LS) Mean Difference|124.2|||<|0.001|TWO_SIDED|95.0|89.8|158.7|||Mixed Model for Repeated Measure||LS Mean difference between the treatment groups and p-values for the comparisons of each guselkumab treatment group with the placebo group were based on MMRM analysis.|||158.7|89.8|<0.001
70885970|NCT03466411|141257801|SUPERIORITY||LS Mean Difference|102.7|||<|0.001|TWO_SIDED|95.0|68.5|136.9|||Mixed Model for Repeated Measure||LS Mean difference between the treatment groups and p-values for the comparisons of each guselkumab treatment group with the placebo group were based on MMRM analysis.|||136.9|68.5|<0.001
70885971|NCT03466411|141257801|SUPERIORITY||LS Mean Difference|108.7|||<|0.001|TWO_SIDED|95.0|73.9|143.5|||Mixed Model for Repeated Measure||LS Mean difference between the treatment groups and p-values for the comparisons of each guselkumab treatment group with the placebo group were based on MMRM analysis.|||143.5|73.9|<0.001
70885972|NCT03466411|141257802|SUPERIORITY||Adjusted treatment difference|38.1|||<|0.001|TWO_SIDED|95.0|27.3|48.9|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||48.9|27.3|<0.001
70885973|NCT03466411|141257802|SUPERIORITY||Adjusted treatment difference|42.8|||<|0.001|TWO_SIDED|95.0|31.6|53.9|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel-Haenszel stratum weights and the Sato variance estimator.|||53.9|31.6|<0.001
70885974|NCT03466411|141257803|SUPERIORITY||Adjusted treatment difference|33.7|||<|0.001|TWO_SIDED|95.0|24.1|43.2|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||43.2|24.1|<0.001
70885975|NCT03466411|141257803|SUPERIORITY||Adjusted treatment difference|32.9|||<|0.001|TWO_SIDED|95.0|23.5|42.4|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel-Haenszel stratum weights and the Sato variance estimator.|||42.4|23.5|<0.001
70885976|NCT03466411|141257804|SUPERIORITY||Adjusted treatment difference|34.2|||<|0.001|TWO_SIDED|95.0|23.2|45.3|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||45.3|23.2|<0.001
70885977|NCT03466411|141257804|SUPERIORITY||Adjusted treatment difference|35.0|||<|0.001|TWO_SIDED|95.0|23.5|46.5|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel-Haenszel stratum weights and the Sato variance estimator.|||46.5|23.5|<0.001
70885978|NCT03466411|141257805|SUPERIORITY||Adjusted treatment difference|27.9|||<|0.001|TWO_SIDED|95.0|18.7|37.1|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel-Haenszel stratum weights and the Sato variance estimator.|||37.1|18.7|<0.001
70885979|NCT03466411|141257805|SUPERIORITY||Adjusted treatment difference|30.8|||<|0.001|TWO_SIDED|95.0|21.3|40.3|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel-Haenszel stratum weights and the Sato variance estimator.|||40.3|21.3|<0.001
70885980|NCT03466411|141257806|SUPERIORITY||Adjusted treatment difference|25.1|||<|0.001|TWO_SIDED|95.0|14.1|36.2|||Mantel Haenszel||Treatment difference between combined guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||36.2|14.1|<0.001
70885981|NCT03466411|141257807|SUPERIORITY||Adjusted treatment difference|27.7|||<|0.001|TWO_SIDED|95.0|19.3|36.1|||Mantel Haenszel||Treatment difference between combined guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||36.1|19.3|<0.001
70885982|NCT03466411|141257808|SUPERIORITY||Adjusted treatment difference|31.2|||<|0.001|TWO_SIDED|95.0|21.1|41.3|||Mantel Haenszel||Treatment difference between combined guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||41.3|21.1|<0.001
70885983|NCT03466411|141257809|SUPERIORITY||Adjusted treatment difference|22.1|||<|0.001|TWO_SIDED|95.0|12.2|31.9|||Mantel Haenszel||Treatment difference between combined guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||31.9|12.2|<0.001
70885984|NCT03778931|141257840|OTHER||Hazard Ratio (HR)|0.546||||0.0005|TWO_SIDED|95.0|0.387|0.768|||Log Rank|The p-value was generated by using a two-sided stratified log-rank test.||The analysis was performed using a stratified Cox Proportional Hazards model with ties=Efron and the stratification factors: prior treatment with fulvestrant (yes vs no) and presence of visceral metastases (yes vs no); the CI calculated using a profile likelihood approach.||0.768|0.387|0.0005
70885985|NCT03778931|141257841|OTHER||Hazard Ratio (HR)|0.697||||0.0018|TWO_SIDED|95.0|0.552|0.88|||Log Rank|The p-value was generated by using a two-sided stratified log-rank test.||The analysis was performed using a stratified Cox Proportional Hazards model with ties=Efron and the stratification factors: prior treatment with fulvestrant (yes vs no) and presence of visceral metastases (yes vs no); the CI calculated using a profile likelihood approach.||0.880|0.552|0.0018
70885986|NCT03778931|141257842|OTHER||Hazard Ratio (HR)|0.592||||0.0325|TWO_SIDED|95.0|0.361|0.958||The p-value was generated by using a two-sided stratified log-rank test.|Log Rank|||The analysis was performed using a stratified Cox Proportional Hazards model with ties=Efron and the stratification factors: prior treatment with fulvestrant (yes vs no) and presence of visceral metastases (yes vs no); the CI calculated using a profile likelihood approach.||0.958|0.361|0.0325
70885987|NCT03778931|141257843|OTHER||Hazard Ratio (HR)|0.742||||0.0697|TWO_SIDED|95.0|0.536|1.025|||Log Rank|The p-value was generated by using a two-sided stratified log-rank test.|Applied a stratified Cox Proportional Hazards model with ties=Efron and the stratification factors: ESR1-mutational status (ESR1-mut vs ESR1-wt), prior treatment with fulvestrant (yes vs no) and presence of visceral metastases (yes vs no).|||1.025|0.536|0.0697
70885988|NCT02115282|141257844|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.3|TWO_SIDED|95.0|0.67|1.13||The p value was based on stratified log rank test, the threshold for significance was two-sided p value of 0.2%.|Log Rank|||||1.13|0.67|0.30
70885989|NCT02115282|141257845|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.94|TWO_SIDED|95.0|0.82|1.21||The p value was based on stratified log rank test, stratified on the four randomization factors. The threshold for statistical significance was two-sided p value of 3.7% after taking into account the five interim analyses of OS into account.|Log Rank|||||1.21|0.82|0.94
70885990|NCT02026115|141257890|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||||||.43
70885991|NCT02026115|141257891|SUPERIORITY|||||||0.02||||||Experimental group performed worse than usual care.|Mixed Models Analysis|||||||.02
70885992|NCT02026115|141257892|SUPERIORITY|||||||0.32|||||||Regression, Linear|||||||.32
70885993|NCT02026115|141257893|SUPERIORITY|||||||0.36|||||||Regression, Logistic|||||||.36
70885994|NCT02026115|141257894|SUPERIORITY|||||||0.01|||||||Regression, Linear|||||||.01
70885995|NCT02026115|141257895|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
70885996|NCT04084769|141257933|OTHER|95% Confidence Interval (CI) of the difference in percentage was calculated from the Wilson Score method without continuity correction.|Difference in percentage|1.65|||||TWO_SIDED|95.0|-3.58|6.95||||||Serogroup A||6.95|-3.58|
70885997|NCT04084769|141257933|OTHER|95% CI of the difference in percentage was calculated from the Wilson Score Method without continuity correction.|Difference in percentage|-1.74|||||TWO_SIDED|95.0|-5.5|1.6||||||Serogroup C||1.60|-5.50|
70885998|NCT04084769|141257933|OTHER|95% CI of the difference in percentage was calculated from the Wilson Score Method without continuity correction.|Difference in percentage|-1.15|||||TWO_SIDED|95.0|-4.09|1.14||||||Serogroup Y||1.14|-4.09|
70885999|NCT04084769|141257933|OTHER|95% CI of the difference in percentage was calculated from the Wilson Score Method without continuity correction.|Difference in percentage|-1.16|||||TWO_SIDED|95.0|-4.72|2.07||||||Serogroup W||2.07|-4.72|
70886000|NCT06425458|141257970|OTHER|||||||0.0011||||||Threshold for statistical significance: P \<= 0.05. As this was an exploratory analysis only, p-values were not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-tests were conducted to compare T1 and T2 Self-Esteem (MAPS20 subscale) scores. This analysis included participants who completed both T1 and T2 data collection (n = 18).||||0.0011
70886001|NCT06425458|141257970|OTHER|||||||0.0719||||||Threshold for statistical significance: P \<= .05. As this was an exploratory analysis only, p-values were not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-tests were conducted to compare T1 and T2 Purpose in Life (MAPS20 subscale) scores. This analysis included participants who completed both T1 and T2 data collection (n = 18).||||0.0719
70886002|NCT06425458|141257970|OTHER|||||||0.7991||||||Threshold for statistical significance: P \<= .05. As this was an exploratory analysis only, p-values were not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-tests were conducted to compare T1 and T2 Locus of Control (MAPS20 subscale) scores. This analysis included participants who completed both T1 and T2 data collection (n = 18).||||0.7991
70886003|NCT06425458|141257970|OTHER|||||||0.2208||||||Threshold for statistical significance: P \<= .05. As this was an exploratory analysis only, p-values were not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-tests were conducted to compare T1 and T2 Self-Efficacy (MAPS20 subscale) scores. This analysis included participants who completed both T1 and T2 data collection (n = 18).||||0.2208
70886004|NCT06425458|141257970|OTHER||Spearman partial correlation coefficient|0.37|||||TWO_SIDED|||||||||We conducted an exploratory, descriptive analysis investigating the relationship between leadership program attendance and identity capital at T2, accounting for T1 scores (MAPS20 subscale: Self-Esteem). This analysis included participants who completed both T1 and T2 data collection (n = 18). We calculated the Spearman correlation coefficient only. Power calculation does not apply for this analysis.||||
70886005|NCT06425458|141257970|OTHER||Spearman partial correlation coefficient|-0.29|||||TWO_SIDED|||||||||We conducted an exploratory, descriptive analysis investigating the relationship between leadership program attendance and identity capital at T2, accounting for T1 scores (MAPS20 subscale: Purpose in Life). This analysis included participants who completed both T1 and T2 data collection (n = 18). We calculated the Spearman correlation coefficient only. Power calculation does not apply for this analysis.||||
70886006|NCT06425458|141257970|OTHER||Spearman partial correlation coefficient|-0.58|||||TWO_SIDED|||||||||We conducted an exploratory, descriptive analysis investigating the relationship between leadership program attendance and identity capital at T2, accounting for T1 scores (MAPS20 subscale: Locus of Control). This analysis included participants who completed both T1 and T2 data collection (n = 18). We calculated the Spearman correlation coefficient only. Power calculation does not apply for this analysis.||||
70886007|NCT06425458|141257970|OTHER||Spearman partial correlation coefficient|-0.14|||||TWO_SIDED|||||||||We conducted an exploratory, descriptive analysis investigating the relationship between leadership program attendance and identity capital at T2, accounting for T1 scores (MAPS20 subscale: Self-Efficacy). This analysis included participants who completed both T1 and T2 data collection (n = 18). We calculated the Spearman correlation coefficient only. Power calculation does not apply for this analysis.||||
70886008|NCT00445328|141258017|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is based on chi-square test with alpha as 0.01.|Chi-squared|||||||1.0000
70886009|NCT00445328|141258019|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Chi-squared|||Major Bleeding||||1.0000
70886010|NCT00445328|141258022|SUPERIORITY_OR_OTHER|||||||0.1355||95.0|||||Chi-squared|||||||0.1355
70886011|NCT03890367|141258084|NON_INFERIORITY|The two-sided 97.5 percent (%) confidence interval (CI) was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 97.5% CI of the percentage difference between compared groups was greater than (\>) -10%.|Difference in Percentage|10.43|||||TWO_SIDED|97.5|5.68|16.2||||||||16.2|5.68|
70886012|NCT03890367|141258085|NON_INFERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The non-inferiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1/1.5.|GMT Ratio|16.3|||||TWO_SIDED|97.5|12.7|21.0||||||||21.0|12.7|
70886013|NCT03890367|141258086|SUPERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The superiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1.|GMT Ratio|16.3|||||TWO_SIDED|97.5|12.7|21.0||||||||21.0|12.7|
70886014|NCT03890367|141258087|SUPERIORITY|The two-sided 97.5% CI was calculated based on the Wilson score method without continuity correction. The superiority was demonstrated if the lower limit of the 97.5% CI of the percentage difference between compared groups was \>0%.|Difference in Percentage|10.43|||||TWO_SIDED|97.5|5.68|16.2||||||||16.20|5.68|
70886015|NCT03890367|141258088|NON_INFERIORITY|The two-sided 97.5% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 97.5% CI of the percentage difference between compared groups was \>-10%.|Difference in Percentage|0.0|||||TWO_SIDED|97.5|-2.3|2.28||||||||2.28|-2.30|
70886016|NCT03890367|141258089|NON_INFERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The non-inferiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1/1.5.|GMT Ratio|1.32|||||TWO_SIDED|97.5|1.06|1.64||||||||1.64|1.06|
70886017|NCT03890367|141258090|SUPERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The superiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1.|GMT Ratio|1.32|||||TWO_SIDED|97.5|1.06|1.64||||||||1.64|1.06|
70886018|NCT03890367|141258091|NON_INFERIORITY|The two-sided 97.5% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 97.5% CI of the percentage difference between compared groups was \>-10%.|Difference in Percentage|5.24|||||TWO_SIDED|97.5|1.83|9.85||||||||9.85|1.83|
70886019|NCT03890367|141258092|NON_INFERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The non-inferiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1/1.5.|GMT Ratio|6.8|||||TWO_SIDED|97.5|5.04|9.18||||||||9.18|5.04|
70886020|NCT03890367|141258093|SUPERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The superiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1.|GMT Ratio|6.8|||||TWO_SIDED|97.5|5.04|9.18||||||||9.18|5.04|
70886021|NCT03890367|141258094|NON_INFERIORITY|The two-sided 97.5% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 97.5% CI of the percentage difference between compared groups was \>-10%.|Difference in Percentage|0.0|||||TWO_SIDED|97.5|-2.71|2.67||||||||2.67|-2.71|
70886022|NCT03890367|141258095|NON_INFERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The non-inferiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1/1.5.|GMT Ratio|2.27|||||TWO_SIDED|97.5|1.82|2.84||||||||2.84|1.82|
70886023|NCT03890367|141258096|SUPERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The superiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1.|GMT Ratio|2.27|||||TWO_SIDED|97.5|1.82|2.84||||||||2.84|1.82|
70886024|NCT02533921|141258097|SUPERIORITY||Mean Difference (Final Values)|1.5022|STANDARD_ERROR_OF_MEAN|0.6749||0.0272|TWO_SIDED|95.0|0.1706|2.8338|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.||2.8338|0.1706|0.0272
70886025|NCT02533921|141258098|SUPERIORITY||Mean Difference (Final Values)|-1.1236|STANDARD_ERROR_OF_MEAN|0.8267||0.1761|TWO_SIDED|95.0|-2.7569|0.5097|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.||0.5097|-2.7569|0.1761
70886026|NCT02533921|141258099|SUPERIORITY||Mean Difference (Final Values)|-0.4616|STANDARD_ERROR_OF_MEAN|0.3889||0.2369|TWO_SIDED|95.0|-1.2291|0.3059|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.||0.3059|-1.2291|0.2369
70886027|NCT02533921|141258100|SUPERIORITY||Mean Difference (Final Values)|-0.1309||||0.7484|TWO_SIDED|95.0|-0.9349|0.673|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|||0.6730|-0.9349|0.7484
70886028|NCT02533921|141258101|SUPERIORITY||Mean Difference (Final Values)|-0.6878|STANDARD_ERROR_OF_MEAN|0.4789||0.1529|TWO_SIDED|95.0|-1.6338|0.2581|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.||0.2581|-1.6338|0.1529
70886029|NCT02533921|141258102|SUPERIORITY||Mean Difference (Final Values)|-0.1608|STANDARD_ERROR_OF_MEAN|0.3934||0.6834|TWO_SIDED|95.0|-0.9382|0.6167|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.||0.6167|-0.9382|0.6834
70886030|NCT04368429|141258111|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% Confidence Interval (CI) of the difference in percentage was greater than (\>) -10% for the serogroup A.|Difference in percentage|20.27|||||TWO_SIDED|95.0|11.38|28.75|||||95% CI of the difference in percentage was calculated from the Wilson Score method without continuity correction.|Serogroup A||28.75|11.38|
70886031|NCT04368429|141258111|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in percentage was \>-10% for the serogroup C.|Difference in percentage|33.98|||||TWO_SIDED|95.0|26.2|41.5|||||95% CI of the difference in percentage was calculated from the Wilson Score method without continuity correction.|Serogroup C||41.50|26.20|
70886032|NCT04368429|141258111|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in percentage was \>-10% for the serogroup Y.|Difference in percentage|34.22|||||TWO_SIDED|95.0|26.66|41.64|||||95% CI of the difference in percentage was calculated from the Wilson Score method without continuity correction.|Serogroup Y||41.64|26.66|
70886033|NCT04368429|141258111|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in percentage was \>-10% for the serogroup W.|Difference in percentage|38.19|||||TWO_SIDED|95.0|28.93|46.53|||||95% CI of the difference in percentage was calculated from the Wilson Score method without continuity correction.|Serogroup W||46.53|28.93|
70886034|NCT01167712|141258121|SUPERIORITY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.74|1.06||||||Estimated hazard of first progression or death for weekly paclitaxel treatment relative to standard 3 week paclitaxel.||1.06|.74|
70886035|NCT01167712|141258122|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.72|1.23||||||||1.23|.72|
70886036|NCT02530294|141258161|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||< 0.001
70886037|NCT02530294|141258162|OTHER||||||<|0.001|||||||ANCOVA|Ranked ANCOVA||||||<0.001
70886038|NCT02530294|141258163|OTHER||||||<|0.001|||||||ANCOVA|Ranked ANCOVA||||||< 0.001
70886039|NCT02530294|141258164|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||< 0.001
70886040|NCT02530294|141258165|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||< 0.001
70886041|NCT01948375|141258166|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
70886042|NCT01948375|141258168|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.35||||0.007||95.0|1.26|4.4||For the comparison of direct effect of placebo needle and real needle, p=0.007|Generalized Estimating Equation|||||4.40|1.26|0.007
70886043|NCT01948375|141258169|SUPERIORITY_OR_OTHER||||||=|0.006||||||"for the comparison of difference of acupuncture pain in two periods between the two groups,t=-2.88, p=0.006.~t=-2.88 refers to the t value of t test."|t-test, 2 sided|||||||=0.006
70886044|NCT01948375|141258170|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63|||=|0.048||95.0|1.01|2.64||For the comparison of direct effect of placebo needle and real needle, p=0.048|Generalized Estimating Equation|||||2.64|1.01|=0.048
70886045|NCT03019627|141258171|SUPERIORITY||difference in least square means|-3.83|||=|0.428|TWO_SIDED|95.0|-13.34|5.68|||ANCOVA|||Frequency statistical analysis||5.68|-13.34|=0.428
70886046|NCT03019627|141258171|SUPERIORITY||difference in least square means|0.16|||=|0.974|TWO_SIDED|95.0|-9.45|9.76|||ANCOVA|||Severity statistical analysis||9.76|-9.45|=0.974
70886047|NCT03019627|141258172|SUPERIORITY||Difference in least square means|-1.12|||=|0.783|TWO_SIDED|95.0|-9.14|6.91|||ANCOVA|||frequency statistical analysis - week 4||6.91|-9.14|=0.783
70886048|NCT03019627|141258172|SUPERIORITY||difference in least square means|-3.82|||=|0.461|TWO_SIDED|95.0|-14.1|6.41|||ANCOVA|||Frequency statistical analysis - week 8||6.41|-14.1|=0.461
70886049|NCT03019627|141258172|SUPERIORITY||difference in least square means|-15.3|||=|0.004|TWO_SIDED|95.0|-25.6|-4.97|||ANCOVA|||Frequency statistical analysis - week 12||-4.97|-25.6|=0.004
70886050|NCT03019627|141258172|SUPERIORITY||difference in least square means|2.55|||=|0.544|TWO_SIDED|95.0|-5.72|10.82|||ANCOVA|||Severity statistical analysis - week 4||10.82|-5.72|=0.544
70886051|NCT03019627|141258172|SUPERIORITY||difference in least square means|1.06|||=|0.837|TWO_SIDED|95.0|-9.12|11.24|||ANCOVA|||Severity statistical analysis - week 8||11.24|-9.12|=0.837
70886052|NCT03019627|141258172|SUPERIORITY||difference in least square means|-13.8|||=|0.007|TWO_SIDED|95.0|-23.7|3.88|||ANCOVA|||Severity statistical analysis - week 12||3.88|-23.7|=0.007
70886053|NCT03019627|141258173|SUPERIORITY||Difference in least square means|-0.7|||=|0.046|TWO_SIDED|95.0|-1.38|-0.01|||ANCOVA|||week 4||-0.01|-1.38|=0.046
70886054|NCT03019627|141258173|SUPERIORITY||Difference in least square means|-0.3|||=|0.425|TWO_SIDED|95.0|-1.05|0.44|||ANCOVA|||week 8||0.44|-1.05|=0.425
70886055|NCT03019627|141258173|SUPERIORITY||Difference in least square means|-0.09|||=|0.788|TWO_SIDED|95.0|-0.76|0.58|||ANCOVA|||week 12||0.58|-0.76|=0.788
70886056|NCT03019627|141258174|SUPERIORITY||Difference in least square means|-0.71|||=|0.265|TWO_SIDED|95.0|-1.95|0.54|||ANCOVA|||week 4||0.54|-1.95|=0.265
70886057|NCT03019627|141258174|SUPERIORITY||Difference in least square means|-1.38|||=|0.026|TWO_SIDED|95.0|-2.59|-0.17|||ANCOVA|||week 8||-0.17|-2.59|=0.026
70886058|NCT03019627|141258174|SUPERIORITY||Difference in least square means|-0.6|||=|0.361|TWO_SIDED|95.0|-1.9|0.7|||ANCOVA|||week 12||0.70|-1.90|=0.361
70886059|NCT03019627|141258175|SUPERIORITY||Difference in least square means|-0.25|||=|0.323|TWO_SIDED|95.0|-0.76|0.25|||ANCOVA|||week 4||0.25|-0.76|=0.323
70886060|NCT03019627|141258175|SUPERIORITY||Difference in least square means|0.03|||=|0.908|TWO_SIDED|95.0|-0.55|0.62|||ANCOVA|||week 8||0.62|-0.55|=0.908
70886061|NCT03019627|141258175|SUPERIORITY||Difference in least square means|-0.12|||=|0.702|TWO_SIDED|95.0|-0.76|0.52|||ANCOVA|||week 12||0.52|-0.76|=0.702
70886062|NCT03019627|141258176|SUPERIORITY||Difference in least square means|5.75|||=|0.003|TWO_SIDED|95.0|2.02|9.48|||ANCOVA|||||9.48|2.02|=0.003
70886063|NCT02103478|141258197|EQUIVALENCE|The 95% confidence intervals for the difference (oral - IV) were generated using an ANOVA model separately for Course 1 and Course 2.|Mean Difference (Final Values)|-0.144|||||TWO_SIDED|95.0|-3.165|2.876|||||Course 1|||2.876|-3.165|
70886064|NCT02103478|141258197|EQUIVALENCE|The 95% confidence intervals for the difference (oral - IV) were generated using an ANOVA model separately for Course 1 and Course 2.|Mean Difference (Final Values)|-0.087|||||TWO_SIDED|95.0|-3.463|3.288|||||Course 2|||3.288|-3.463|
70886065|NCT02103478|141258197|EQUIVALENCE|The 95% confidence intervals for the difference (oral - IV) were generated using an ANOVA model separately for Course 1 and Course 2.|Mean Difference (Final Values)|-2.588|||||TWO_SIDED|95.0|-6.074|0.899|||||Course 1|||0.899|-6.074|
70886066|NCT02103478|141258197|EQUIVALENCE|The 95% confidence intervals for the difference (oral - IV) were generated using an ANOVA model separately for Course 1 and Course 2.|Mean Difference (Final Values)|-0.096|||||TWO_SIDED|95.0|-5.08|4.888|||||Course 2|||4.888|-5.080|
70886067|NCT04530552|141258265|OTHER||See above|0.895|||||TWO_SIDED|||||||||Posterior probability of observing a response rate ≥ 50%||||
70886068|NCT04530552|141258265|OTHER||See above|0.943|||||TWO_SIDED|||||||||Posterior probability of observing a response rate ≥ 25%||||
70886069|NCT04530552|141258266|OTHER|Two-sided paired t-test at 2.5% significance level (Bonferroni correction)||||||0.034||||||Two-sided paired t-test at 2.5% significance level (Bonferroni correction)|paired t-test|||||||0.034
70886070|NCT04530552|141258266|OTHER|||||||0.252||||||Two-sided paired t-test at 2.5% significance level (Bonferroni correction)|paired t-test|||||||0.252
70886071|NCT04530552|141258267|OTHER|||||||1||||||Significance level of 2.5% (Bonferroni correction)|Pearson correlation|||Correlation with % change PSA at end-of-intervention||||1.0
70886072|NCT04530552|141258267|OTHER|||||||1||||||Significance level of 2.5% (Bonferroni correction)|Pearson correlation|||Correlation with % change PSA at end-of-intervention||||1.0
70886073|NCT04530552|141258268|OTHER|||||||0.658||||||two-sided paired t-test (no Bonferroni adjustment)|paired t-test|||||||0.658
70886074|NCT04530552|141258268|OTHER|||||||0.167||||||Two-sided paired t-test (no Bonferroni adjustment)|paired t-test|||||||0.167
70886075|NCT03748641|141258272|SUPERIORITY||Hazard Ratio (HR)|0.729||||0.0217|TWO_SIDED|95.0|0.556|0.956|||Log Rank|||||0.956|0.556|0.0217
70886076|NCT03748641|141258273|SUPERIORITY||Hazard Ratio (HR)|0.533||||0.0014|TWO_SIDED|95.0|0.361|0.789|||Log Rank|||||0.789|0.361|0.0014
70886077|NCT06034496|141258282|SUPERIORITY|||||||0.012||||||CES main effect|ANOVA|||||||.012
70886078|NCT06034496|141258282|SUPERIORITY|||||||0.33||||||Session main effect|ANOVA|||||||.33
70886079|NCT06034496|141258282|SUPERIORITY|||||||0.85||||||Session (baseline, follow-up) x CES|ANOVA|||||||.85
70886080|NCT06034496|141258283|SUPERIORITY|||||||0.6||||||CES main effect|ANOVA|||||||.6
70886081|NCT06034496|141258283|SUPERIORITY|||||||0.9||||||Session main effect|ANOVA|||||||.9
70886082|NCT06034496|141258283|SUPERIORITY|||||||0.05||||||CES x Session interaction|ANOVA|||||||.05
70886083|NCT06034496|141258284|SUPERIORITY|||||||0.26||||||CES main effect|ANOVA|||||||.26
70886084|NCT06034496|141258284|SUPERIORITY|||||||0.17||||||Session main effect|ANOVA|||||||.17
70886085|NCT06034496|141258284|SUPERIORITY|||||||0.73||||||CES x Session main effect|ANOVA|||||||.73
70886086|NCT06034496|141258285|SUPERIORITY|||||||0.18||||||CES main effect|ANOVA|||||||.18
70886087|NCT06034496|141258285|SUPERIORITY|||||||0||||||Time main effect|ANOVA|||||||.00
70886088|NCT06034496|141258285|SUPERIORITY|||||||0.53||||||CES main effect|ANOVA|||||||.53
70886089|NCT06034496|141258285|SUPERIORITY|||||||0.07||||||CES x Time interaction|ANOVA|||||||.07
70886090|NCT06034496|141258285|SUPERIORITY|||||||0.46||||||CES x Session|ANOVA|||||||.46
70886091|NCT06034496|141258285|SUPERIORITY|||||||0.01||||||Time x Session interaction|ANOVA|||||||.01
70886092|NCT06034496|141258285|SUPERIORITY|||||||0.29||||||CES x Time x Session interaction|ANOVA|||||||.29
70886093|NCT06034496|141258286|SUPERIORITY|||||||0.1||||||CES main effect|ANOVA|||||||.10
70886094|NCT06034496|141258286|SUPERIORITY|||||||0||||||Time main effect|ANOVA|||||||.00
70886095|NCT06034496|141258286|SUPERIORITY|||||||0.81||||||Session main effect|ANOVA|||||||.81
70886096|NCT06034496|141258286|SUPERIORITY|||||||0.4||||||CES x Time interaction|ANOVA|||||||.40
70886097|NCT06034496|141258286|SUPERIORITY|||||||0.35||||||CES x Session interaction|ANOVA|||||||.35
70886098|NCT06034496|141258286|SUPERIORITY|||||||0||||||Time x Session interaction|ANOVA|||||||.00
70886099|NCT06034496|141258286|SUPERIORITY|||||||0.4||||||CES x Time x Session interaction|ANOVA|||||||.40
70886100|NCT06034496|141258287|SUPERIORITY|||||||0.23||||||STAI-T CES main effect|ANOVA|||||||.23
70886101|NCT06034496|141258287|SUPERIORITY|||||||0.45||||||STAI-T Session main effect|ANOVA|||||||.45
70886102|NCT06034496|141258287|SUPERIORITY|||||||0.38||||||STAI-T CES x Session interaction|ANOVA|||||||.38
70886103|NCT06034496|141258287|SUPERIORITY|||||||0.4||||||STAI-S CES main effect|ANOVA|||||||.40
70886104|NCT06034496|141258287|SUPERIORITY|||||||0||||||STAI-S Time main effect|ANOVA|||||||.00
70886105|NCT06034496|141258287|SUPERIORITY|||||||0||||||STAI-S Session main effect|ANOVA|||||||.00
70886106|NCT06034496|141258287|SUPERIORITY|||||||0.2||||||STAI-S CES x Time interaction|ANOVA|||||||.20
70886107|NCT06034496|141258287|SUPERIORITY|||||||0.39||||||STAI-S CES x Session interaction|ANOVA|||||||.39
70886108|NCT06034496|141258287|SUPERIORITY|||||||0||||||STAI-S Session x Time interaction|ANOVA|||||||.00
70886109|NCT06034496|141258287|SUPERIORITY|||||||0.38||||||STAI-S CES x Time x Session interaction|ANOVA|||||||.38
70886110|NCT06034496|141258288|SUPERIORITY|||||||0.85||||||CES main effect|ANOVA|||||||.85
70886111|NCT06034496|141258288|SUPERIORITY|||||||0.69||||||Session main effect|ANOVA|||||||.69
70886112|NCT06034496|141258288|SUPERIORITY|||||||0.4||||||CES x Session interaction|ANOVA|||||||.4
70886113|NCT06034496|141258289|SUPERIORITY|||||||0.13||||||CES main effect|ANOVA|||||||.13
70886114|NCT06034496|141258289|SUPERIORITY|||||||0.26||||||Session main effect|ANOVA|||||||.26
70886115|NCT06034496|141258289|SUPERIORITY|||||||0.44||||||CES x Session interaction|ANOVA|||||||.44
70886116|NCT06034496|141258290|SUPERIORITY|||||||0.36||||||CES main effect|ANOVA|||||||.36
70886117|NCT06034496|141258290|SUPERIORITY|||||||0||||||Session main effect|ANOVA|||||||.00
70886118|NCT06034496|141258290|SUPERIORITY|||||||0.96||||||CES x Session interaction|ANOVA|||||||.96
70886119|NCT03277261|141258323|SUPERIORITY||Rate Ratio (Ublituximab/Teriflunomide)|0.406|||<|0.0001|TWO_SIDED|95.0|0.268|0.615||GEE (Generalized Estimating Equation) model for the relapse count per participant with logarithmic link function, treatment, region, and baseline Expanded Disability Status Scale (EDSS) strata as covariates and log (years of treatment) as offset.|Negative Binomial Model|||||0.615|0.268|<0.0001
70886120|NCT03277261|141258324|SUPERIORITY||Rate Ratio (Ublituximab/Teriflunomide)|0.033|||<|0.0001|TWO_SIDED|95.0|0.019|0.058||GEE model for the relapse count per participant with logarithmic link function, treatment, region, and baseline EDSS strata as covariates and log (years of treatment) as offset.|Negative Binomial Model|||||0.058|0.019|<0.0001
70886121|NCT03277261|141258325|SUPERIORITY||Rate Ratio (Ublituximab/Teriflunomide)|0.076|||<|0.0001|TWO_SIDED|95.0|0.056|0.104||GEE model for the relapse count per participant with logarithmic link function, treatment, region, and baseline EDSS strata as covariates and log (years of treatment) as offset.|Negative Binomial Model|||||0.104|0.056|<0.0001
70886122|NCT03277261|141258327|SUPERIORITY||Odds Ratio (Ublituximab/Teriflunomide)|5.442|||<|0.0001|TWO_SIDED|95.0|3.536|8.375||Logistic regression model with treatment, region, baseline EDSS strata and log transformed baseline MRI lesion counts (T1 unenhancing, T2, Gd enhancing) as covariates.|Regression, Logistic|||||8.375|3.536|<0.0001
70886123|NCT03277261|141258328|SUPERIORITY||Odds Ratio (Ublituximab/Teriflunomide)|0.872|||=|0.4669|TWO_SIDED|95.0|0.603|1.261||Logistic regression model with treatment, region, baseline EDSS strata, and log-transformed baseline MRI counts (T1 unenhancing, T2, Gd enhancing) as covariates.|Logistic Regression|||||1.261|0.603|=0.4669
70886124|NCT03277261|141258329|SUPERIORITY||Least squares mean difference|-0.072|||<|0.0001|TWO_SIDED|95.0|-0.107|-0.036||The model includes treatment, region, baseline EDSS strata, visit, treatment-by-visit interaction, and baseline volume (cube root transformed) as covariates and an unstructured covariance matrix.|Mixed Model Repeated Measures (MMRM)|||||-0.036|-0.107|<0.0001
70886125|NCT05179421|141258334|OTHER|NONMEM applies nonlinear mixed effects modeling to evaluate the relationship between predicted drug concentration after administration from known pharmacokinetics and a pharmacodynamic effect, in this case being a reduction in pain from sustained heat application.|||||<|0.05|||||||Mixed Models Analysis|||Pain scores over time will first be modeled using NONMEM with derived parameters of maximum effect (Emax) and doses to produce a 50% and 90% maximum drug effect (C50 and C90, respectively), the steepness of the dose response curve (γ), and the time to peak effect. Inter-subject variability (e.g., biological variability) will evaluate additive, proportional, and exponential models. Residual intrasubject variability (e.g., noise) will typically require an additive and multiplicative error model.||||<0.05
70886126|NCT00792610|141258335|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1|STANDARD_DEVIATION|0.05|<|0.05||95.0|0.05|0.15|||t-test, 2 sided|||Chi-square analysis and Fischer's exact test were used for comparing group proportions between seropositive and seronegative participants. GMT and their 95% confidence intervals were also calculated using the software developed by Kirkman, T.W. (18) An ANOVA test was performed to compare the difference of the three groups at one, six and seven months categorized by the anti-HBs titers at 7-10 days after the booster.||.15|.05|<0.05
70886127|NCT04521166|141258349|OTHER|A linear mixed model was used to assess whether there was a difference between Settings 1 and 2.|Slope|-0.0099|STANDARD_ERROR_OF_MEAN|0.01572||0.5291|TWO_SIDED|95.0|-0.04075|0.02095||The a priori threshold for statistical significance was 0.05. P-value was adjusted for multiple comparisons using the Bonferroni correction.|Mixed Models Analysis||Setting 2 was considered as the reference and the estimate reflects whether the slope for Setting 1 is significantly different from the slope for Setting 2|||0.02095|-0.04075|0.5291
70886128|NCT04521166|141258349|OTHER|A linear mixed model was used to assess whether there was a difference between Setting 2 and Setting 3.|Slope|0.1329|STANDARD_ERROR_OF_MEAN|0.0174|<|0.001|TWO_SIDED|95.0|0.0988|0.1671||The a priori threshold for statistical significance was 0.05. P-value was adjusted for multiple comparisons using the Bonferroni correction.|Mixed Models Analysis||Setting 2 was considered as the reference and the estimate reflects whether the slope for Setting 3 is significantly different from the slope for Setting 2|||0.1671|0.09880|<0.001
70886129|NCT04521166|141258349|OTHER|A linear mixed model was used to assess whether there was a difference between Setting 2 and Setting 4.|Slope|0.2016|STANDARD_ERROR_OF_MEAN|0.01812|<|0.0001|TWO_SIDED|95.0|0.166|0.2371||The a priori threshold for statistical significance was 0.05. P-value was adjusted for multiple comparisons using the Bonferroni correction.|Mixed Models Analysis||Setting 2 was considered as the reference and the estimate reflects whether the slope for Setting 4 is significantly different from the slope for Setting|||0.2371|0.1660|<.0001
70886130|NCT04521166|141258349|OTHER|A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after controlling for age and degree of hearing loss (decibel hearing level)|Slope|0.002||||0.242|TWO_SIDED|||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after controlling for age and degree of hearing loss (decibel hearing level)||||0.242
70886131|NCT04521166|141258349|OTHER|A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after controlling for age and degree of hearing loss (decibel hearing level)|Slope|0.002||||0.242|TWO_SIDED|||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after controlling for age and degree of hearing loss (decibel hearing level)||||0.242
70886132|NCT04521166|141258349|OTHER|A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after accounting for age and degree of hearing loss (decibel hearing level).|Slope|0.002||||0.242|TWO_SIDED|||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after accounting for age and degree of hearing loss (decibel hearing level).||||0.242
70886133|NCT04521166|141258349|OTHER|A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after accounting for age and degree of hearing loss (decibel hearing level).|Slope|0.002||||0.242|TWO_SIDED|||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after accounting for age and degree of hearing loss (decibel hearing level).||||0.242
70886134|NCT02614547|141258351|SUPERIORITY||Least Squares Mean Difference|-12.22|STANDARD_ERROR_OF_MEAN|4.081||0.008|TWO_SIDED|95.0|-20.77|-3.67|||MMRM|||Mixed Effects Model for Repeated Measure (MMRM) used an unstructured covariance model time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment.||-3.67|-20.77|0.008
70886135|NCT02614547|141258352|SUPERIORITY||Odds Ratio (OR)|4.08||||0.198|TWO_SIDED|95.0|0.49|37.67|||Fisher Exact|||60 Hours||37.67|0.49|0.198
70886136|NCT02614547|141258352|SUPERIORITY||Odds Ratio (OR)|16.0||||0.023|TWO_SIDED|95.0|1.31|239.57|||Fisher Exact|||Day 7||239.57|1.31|0.023
70886137|NCT02614547|141258352|SUPERIORITY||Odds Ratio (OR)|6.22||||0.086|TWO_SIDED|95.0|0.7|62.08|||Fisher Exact|||Day 30||62.08|0.70|0.086
70886138|NCT02614547|141258353|SUPERIORITY||Odds Ratio (OR)|23.33||||0.008|TWO_SIDED|95.0|1.56|1152.71|||Fisher Exact|||60 Hours||1152.71|1.56|0.008
70886139|NCT02614547|141258353|SUPERIORITY|||||||0.003|||||||Fisher Exact|||Day 7||||0.003
70886140|NCT02614547|141258353|SUPERIORITY||Odds Ratio (OR)|10.5||||0.03|TWO_SIDED|95.0|1.01|140.57|||Fisher Exact|||Day 30||140.57|1.01|0.030
70886141|NCT02614547|141258354|SUPERIORITY||Least Squares Mean Difference|-15.86|STANDARD_ERROR_OF_MEAN|5.536||0.01|TWO_SIDED|95.0|-27.5|-4.22|||MMRM|||60 Hours: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment||-4.22|-27.50|0.010
70886142|NCT02614547|141258354|SUPERIORITY||Least Square Mean Difference|-15.96|STANDARD_ERROR_OF_MEAN|5.448||0.009|TWO_SIDED|95.0|-27.43|-4.5|||MMRM|||Day 7: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment||-4.50|-27.43|0.009
70886143|NCT02614547|141258354|SUPERIORITY||Least Square Mean Difference|-15.07|STANDARD_ERROR_OF_MEAN|5.213||0.01|TWO_SIDED|95.0|-26.05|-4.09|||MMRM|||Day 30: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment||-4.09|-26.05|0.010
70886144|NCT02614547|141258355|SUPERIORITY||Odds Ratio (OR)|7.0||||0.08|TWO_SIDED|95.0|0.73|90.81|||Fisher Exact|||60 Hours||90.81|0.73|0.080
70886145|NCT02614547|141258355|SUPERIORITY||Odds Ratio (OR)|16.0||||0.023|TWO_SIDED|95.0|1.31|239.57|||Fisher Exact|||Day 7||239.57|1.31|0.023
70886146|NCT02614547|141258355|SUPERIORITY||Odds Ratio (OR)|10.67||||0.03|TWO_SIDED|95.0|1.04|142.2|||Fisher Exact|||Day 30||142.20|1.04|0.030
70886147|NCT02614547|141258356|SUPERIORITY||Least Squares Mean Difference|-6.05|STANDARD_ERROR_OF_MEAN|2.466||0.025|TWO_SIDED|95.0|-11.24|-0.86|||MMRM|||60 Hours: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment.||-0.86|-11.24|0.025
70886148|NCT02614547|141258356|SUPERIORITY||Least Squares Mean Difference|-6.46|STANDARD_ERROR_OF_MEAN|2.427||0.016|TWO_SIDED|95.0|-11.57|-1.34|||MMRM|||Day 7: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment.||-1.34|-11.57|0.016
70886149|NCT02614547|141258356|SUPERIORITY||Least Squares Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|2.568||0.018|TWO_SIDED|95.0|-12.25|-1.35|||MMRM|||Day 30: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment.||-1.35|-12.25|0.018
70886150|NCT02614547|141258358|SUPERIORITY||Least Squares Mean Difference|1.87|STANDARD_ERROR_OF_MEAN|2.461||0.457|TWO_SIDED|95.0|-3.3|7.04|||ANCOVA|||60 Hours||7.04|-3.30|0.457
70886151|NCT02614547|141258358|SUPERIORITY||Least Square Mean|-1.47|STANDARD_ERROR_OF_MEAN|-1.47||0.613|TWO_SIDED|95.0|-7.5|4.55|||ANCOVA|||Day 7||4.55|-7.50|0.613
70886152|NCT02614547|141258358|SUPERIORITY||Least Square Mean|-2.1|STANDARD_ERROR_OF_MEAN|2.871||0.474|TWO_SIDED|95.0|-8.13|3.93|||ANCOVA|||Day 30||3.93|-8.13|0.474
70886153|NCT04697628|141258442|SUPERIORITY||Cox Proportional Hazard|0.7||||0.0038|TWO_SIDED|95.0|0.54|0.89||Two-sided p-value calculated from stratified log-rank test.|Stratified log-rank test||Hazard Ratio (HR) was calculated from Cox proportional hazards model and Efron method was used in handling ties and computed using stratification factors at randomization.|||0.89|0.54|0.0038
70886154|NCT04697628|141258443|SUPERIORITY||Cox Proportional Hazard|0.67|||<|0.0001|TWO_SIDED|95.0|0.54|0.82||Two-sided p-value calculated from stratified log-rank test.|Stratified log-rank test||HR was calculated from Cox proportional hazards model and Efron method was used in handling ties and computed using stratification factors at randomization.|||0.82|0.54|<0.0001
70886155|NCT04697628|141258444|SUPERIORITY||Odds Ratio (OR)|4.0|||<|0.0001|TWO_SIDED|95.0|2.1|7.6|||Cochran-Mantel-Haenszel||OR calculated using Cochran-Mantel-Haenszel (CMH) method controlling for stratification factors at randomization.|||7.6|2.1|<0.0001
70886156|NCT00087633|141258472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2||||0.725|TWO_SIDED|95.0|-20.8|14.4|||Cochran-Mantel-Haenszel|||||14.4|-20.8|0.725
70886157|NCT01110915|141258474|SUPERIORITY_OR_OTHER||Percentage|0.0|||<|0.0001|ONE_SIDED|97.5||2.5||A priori threshold for statistical significance was 0.025|exact test of binomial proportions|||Null Hypothesis: MRI-related complication rate between the MRI scan and one-month post-MRI \>=10%.||2.5||<0.0001
70886158|NCT01110915|141258475|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Difference in percentages|0.0|||||||||||Farrington-Manning test|A priori threshold for statistical significance was 0.025. Because there were no failures in either group, a p-value could not be calculated.||Null hypothesis: % successes MRI group ≤ % successes Control group -10%.||||
70886159|NCT01110915|141258476|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Difference in percentages|0.5|||<|0.0001|TWO_SIDED|95.0|-5.0|5.9||A priori threshold for statistical significance was 0.025.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group -10%.||5.9|-5.0|<0.0001
70886160|NCT01110915|141258477|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Difference in percentages|1.5||||0.001|ONE_SIDED|95.0|-6.1|||A priori threshold for statistical significance was 0.05.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group - 10%.|||-6.1|0.0010
70886161|NCT01110915|141258478|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Difference in percentages|0.1||||0.0001|ONE_SIDED|95.0|-4.6|||A priori threshold for statistical significance was 0.05.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group - 10%.|||-4.6|0.0001
70886162|NCT01110915|141258479|SUPERIORITY_OR_OTHER||Percentage|0.0|||<|0.0001|ONE_SIDED|95.0||1.9||A priori threshold for statistical significance was 0.05.|exact test of binomial proportions|||Null hypothesis: the proportion of subjects with sustained ventricular arrhythmias and asystole during MRI scans \>= 10%.||1.9||<0.0001
70886163|NCT01110915|141258480|SUPERIORITY_OR_OTHER||Complication rate at 4 months|7.7|||<|0.05|ONE_SIDED|95.0||10.9||A priori threshold for statistical significance was 0.05.|Kaplan-Meier method|||Null hypothesis: the system-related complication rate between the implant procedure and the 4-months visit \>= 20%.||10.9||<0.05
70886164|NCT03985813|141258481|SUPERIORITY|||||||0.083||||||Threshold for significance P\<0.05|Chi-squared|||||||0.083
70886165|NCT03985813|141258482|SUPERIORITY||||||>|0.99||||||Threshold for statistical significance P\<0.05|Chi-squared|||||||>0.99
70886166|NCT02161718|141258489|SUPERIORITY||Hazard Ratio (HR)|0.91|STANDARD_ERROR_OF_MEAN|0.251||0.746|TWO_SIDED|95.0|0.53|1.56|||Log Rank|||||1.56|0.53|0.746
70886167|NCT02161718|141258490|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.372|TWO_SIDED|95.0|0.43|1.37|||Andersen-Gill Recurrent-Event Cox Model|||||1.37|0.43|0.372
70886168|NCT02161718|141258491|SUPERIORITY||Odds Ratio (OR)|0.99||||0.963|TWO_SIDED|95.0|0.56|1.73|||Regression, Logistic|||||1.73|0.56|0.963
70886169|NCT00207142|141258510|NON_INFERIORITY_OR_EQUIVALENCE|Efficacy at Week 48 on the Switch Arm was considered to be non-inferior to the Continuation Arm if the lower limit of the 95% Confidence Interval was greater than -15%.|Difference in proportions|2.9||||||95.0|-9.8|15.5|||Normal approximation|||The planned sample size of 178 randomized subjects (89 on each regimen) provides at least 80% power to demonstrate that the response rate on ATV is within a 15% margin of the response rate on ATV/RTV assuming: a 2-sided 95% confidence interval for the difference in response rate between treatment regimens (switch-continuation); a response rate of 85% in both the Continuation and Switch regimens; a margin of -15% for the difference in response rates between treatment regimens.||15.5|-9.8|
70886170|NCT00207142|141258511|SUPERIORITY_OR_OTHER||Difference in Proportions|5.0||||||95.0|-6.0|16.1|||Normal Approximation|||||16.1|-6.0|
70886171|NCT00207142|141258512|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.97||||||95.0|0.5|1.88|||Cox Proportional Hazards Model|||Covariate in the model: treatment regimen.||1.88|0.50|
70886172|NCT00207142|141258513|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.84||||||95.0|0.37|1.9|||Cox Proportional Hazards Model|||Covariate in the model: treatment regimen||1.90|0.37|
70886173|NCT00207142|141258514|SUPERIORITY_OR_OTHER||Difference in means at Week 48|7.0||||||95.0|-38.0|53.0|||Normal approximation|||||53|-38|
70886174|NCT01857063|141258527|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares (LS) Means|-0.01||||0.913|TWO_SIDED|95.0|-0.11|0.1||Longitudinal Data Analysis (LDA) model with baseline TNSS as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.|Longitudinal Data Analysis (LDA)|||||0.10|-0.11|0.913
70886175|NCT01857063|141258529|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.0||||0.953|TWO_SIDED|95.0|-0.17|0.16||Longitudinal Data Analysis (LDA) model with baseline Weighted TNSS as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.|LDA|||||0.16|-0.17|0.953
70886176|NCT01857063|141258530|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.0||||0.974|TWO_SIDED|95.0|-0.07|0.07||Longitudinal Data Analysis (LDA) model with baseline nasal congestion score as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.|LDA|||||0.07|-0.07|0.974
70886177|NCT01857063|141258531|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.182|TWO_SIDED|95.0|-0.06|0.01||Longitudinal Data Analysis (LDA) model with baseline nasal discharge score as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.|LDA|||||0.01|-0.06|0.182
70886178|NCT01857063|141258532|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.02||||0.161|TWO_SIDED|95.0|-0.01|0.05||Longitudinal Data Analysis (LDA) model with baseline sneezing score as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.|LDA|||||0.05|-0.01|0.161
70886179|NCT04115358|141258541|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
70886180|NCT04115358|141258542|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
70886181|NCT04115358|141258543|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
70886182|NCT04115358|141258544|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
70886183|NCT04115358|141258545|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
70886184|NCT04115358|141258546|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
70886185|NCT04115358|141258547|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
70886186|NCT04115358|141258548|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
70886187|NCT04115358|141258549|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
70886188|NCT04115358|141258550|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
70886189|NCT04115358|141258551|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
70886190|NCT04115358|141258552|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
70886191|NCT04115358|141258553|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
70886192|NCT04115358|141258554|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
70886193|NCT04115358|141258555|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
70886194|NCT04115358|141258556|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
70886195|NCT04115358|141258557|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
70886196|NCT04115358|141258558|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
70886197|NCT04115358|141258559|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
70886198|NCT04115358|141258560|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
70886199|NCT04115358|141258561|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
70886200|NCT04115358|141258562|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
70886201|NCT04115358|141258563|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
70886202|NCT04115358|141258564|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
70886203|NCT04115358|141258565|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
70886204|NCT04115358|141258566|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
70886205|NCT04115358|141258567|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
70886206|NCT04115358|141258568|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
70886207|NCT04115358|141258569|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
70886208|NCT04115358|141258570|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
70886209|NCT04115358|141258571|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
70886210|NCT04115358|141258572|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
70886211|NCT01205165|141258573|SUPERIORITY_OR_OTHER|||||||0||95.0||||P-value is calculated from Wilcoxon signed rank test to compare difference between baseline and week12|Wilcoxon signed rank test|||Baseline and Week 12||||0.00000
70886212|NCT03306264|141258585|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% confidence interval (CI) of the 5-day AUC0-24 ratio of Least Square Mean (LSM) for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|98.93|||||TWO_SIDED|90.0|92.66|105.6|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|MDS or CMML: IV Decitabine Versus MDS or CMML: ASTX727||105.6|92.66|
70886213|NCT03306264|141258585|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-24 ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|99.64|||||TWO_SIDED|90.0|91.23|108.8|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|AML: IV Decitabine Versus AML: ASTX727||108.8|91.23|
70886214|NCT03306264|141258591|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-inf ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|98.0|||||TWO_SIDED|90.0|91.8|104.6|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|MDS or CMML: IV Decitabine Versus MDS or CMML: ASTX727||104.6|91.80|
70886215|NCT03306264|141258591|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-inf ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|99.61|||||TWO_SIDED|90.0|91.2|108.8|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|AML: IV Decitabine Versus AML: ASTX727||108.8|91.20|
70886216|NCT03306264|141258592|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-last ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|98.11|||||TWO_SIDED|90.0|91.88|104.8|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|MDS or CMML: IV Decitabine Versus MDS or CMML: ASTX727||104.8|91.88|
70886217|NCT03306264|141258592|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-last ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|98.11|||||TWO_SIDED|90.0|89.75|107.2|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|AML: IV Decitabine Versus AML: ASTX727||107.2|89.75|
70886218|NCT03306264|141258593|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-8 ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|97.93|||||TWO_SIDED|90.0|91.74|104.5|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|MDS or CMML: IV Decitabine Versus MDS or CMML: ASTX727||104.5|91.74|
70886219|NCT03306264|141258593|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-8 ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|97.55|||||TWO_SIDED|90.0|89.32|106.5|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|AML: IV Decitabine Versus AML: ASTX727||106.5|89.32|
70886220|NCT04538664|141258618|SUPERIORITY||Hazard Ratio (HR)|0.395|||<|0.0001|TWO_SIDED|95.0|0.296|0.528|||Log Rank|||||0.528|0.296|<0.0001
70886221|NCT03390504|141258657|SUPERIORITY||Hazard Ratio (HR)|0.65|||=|0.0031|TWO_SIDED|95.0|0.48|0.86|||Log Rank|||||0.86|0.48|=0.0031
70886222|NCT03390504|141258657|SUPERIORITY||Hazard Ratio (HR)|1.16|||=|0.2121|TWO_SIDED|95.0|0.92|1.48|||Stratified log-rank test|||||1.48|0.92|=0.2121
70886223|NCT02782949|141258692|SUPERIORITY|||||||0.399|||||||Wilcoxon Rank-Sum test|||||||0.3990
70886224|NCT02782949|141258695|SUPERIORITY|||||||0.74|||||||Fisher Exact|||||||0.74
70886225|NCT03370341|141258706|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||The null hypothesis was that of no difference in levels of IA between Active and Sham stimulation. A paired samples t-test was performed with a significance level of 0.05 (two-tailed).||||.56
70886226|NCT03370341|141258707|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||The null hypothesis was that of no difference in levels of IA between Active and Sham stimulation. A paired samples t-test was performed with a significance level of 0.05 (two-tailed).||||.38
70886227|NCT02984020|141258722|OTHER||Odds Ratio (OR)|0.77|||<|0.0001||95.0|0.69|0.86|||Regression, Logistic|Multiple logistic regression including total treatment duration of Xeljanz as factor||||0.86|0.69|<0.0001
70886228|NCT02984020|141258722|OTHER||Odds Ratio (OR)|2.43|||<|0.0001||95.0|1.64|3.59|||Regression, Logistic|Multiple logistic regression including other past/present disease as factor||||3.59|1.64|<0.0001
70886229|NCT02984020|141258733|OTHER||Odds Ratio (OR)|1.42||||0.0053|TWO_SIDED|95.0|1.11|1.82|||Regression, Logistic|Multiple logistic regression including total duration of treatment with Xeljanz as factor||||1.82|1.11|0.0053
70886230|NCT02610868|141258738|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70886231|NCT02610868|141258738|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70886232|NCT02610868|141258738|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70886233|NCT02610868|141258738|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70886234|NCT02610868|141258738|SUPERIORITY|||||||0.0006|||||||ANCOVA|||||||0.0006
70886235|NCT02610868|141258738|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70886236|NCT02610868|141258738|SUPERIORITY|||||||0.1131|||||||ANCOVA|||||||0.1131
70886237|NCT02610868|141258738|SUPERIORITY|||||||0.0026|||||||ANCOVA|||||||0.0026
70886238|NCT02610868|141258738|SUPERIORITY|||||||0.2569|||||||ANCOVA|||||||0.2569
70886239|NCT02610868|141258739|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70886240|NCT02610868|141258739|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70886241|NCT02610868|141258739|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70886242|NCT02610868|141258739|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70886243|NCT02610868|141258739|SUPERIORITY|||||||0.313|||||||ANCOVA|||||||0.3130
70886244|NCT02610868|141258739|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70886245|NCT02610868|141258739|SUPERIORITY|||||||0.1054|||||||ANCOVA|||||||0.1054
70886246|NCT02610868|141258739|SUPERIORITY|||||||0.0002|||||||ANCOVA|||||||0.0002
70886247|NCT02610868|141258739|SUPERIORITY|||||||0.1663|||||||ANCOVA|||||||0.1663
70886248|NCT02610868|141258741|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70886249|NCT02610868|141258741|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70886250|NCT02610868|141258741|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70886251|NCT02610868|141258741|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70886252|NCT02610868|141258741|SUPERIORITY|||||||0.11|||||||ANCOVA|||||||0.1100
70886253|NCT02610868|141258741|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70886254|NCT02610868|141258741|SUPERIORITY|||||||1|||||||ANCOVA|||||||1.0000
70886255|NCT02610868|141258741|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70886256|NCT02610868|141258741|SUPERIORITY|||||||0.029|||||||ANCOVA|||||||0.0290
70886257|NCT02610868|141258742|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70886258|NCT02610868|141258742|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70886259|NCT02610868|141258742|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70886260|NCT02610868|141258742|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70886261|NCT02610868|141258742|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70886262|NCT02610868|141258742|SUPERIORITY|||||||0.0003|||||||ANCOVA|||||||0.0003
70886263|NCT02610868|141258742|SUPERIORITY|||||||0.9016|||||||ANCOVA|||||||0.9016
70886264|NCT02610868|141258742|SUPERIORITY|||||||0.0753|||||||ANCOVA|||||||0.0753
70886265|NCT02610868|141258742|SUPERIORITY|||||||0.4992|||||||ANCOVA|||||||0.4992
70886266|NCT02610868|141258743|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70886267|NCT02610868|141258743|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70886268|NCT02610868|141258743|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70886269|NCT02610868|141258743|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70886270|NCT02610868|141258743|SUPERIORITY|||||||0.4567|||||||ANCOVA|||||||0.4567
70886271|NCT02610868|141258743|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70886272|NCT02610868|141258743|SUPERIORITY|||||||0.8115|||||||ANCOVA|||||||0.8115
70886273|NCT02610868|141258743|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70886274|NCT02610868|141258743|SUPERIORITY|||||||0.3282|||||||ANCOVA|||||||0.3282
70886275|NCT02610868|141258745|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70886276|NCT02610868|141258745|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70886277|NCT02610868|141258745|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70886278|NCT02610868|141258745|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70886279|NCT02610868|141258745|SUPERIORITY|||||||0.3786|||||||ANCOVA|||||||0.3786
70886280|NCT02610868|141258745|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70886281|NCT02610868|141258745|SUPERIORITY|||||||0.7787|||||||ANCOVA|||||||0.7787
70886282|NCT02610868|141258745|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70886283|NCT02610868|141258745|SUPERIORITY|||||||0.3825|||||||ANCOVA|||||||0.3825
70886284|NCT00667342|141258754|OTHER|The association between response and Ktrans at Week 10 was evaluated.||||||0.0863|||||||Logistic Regression|||||||0.0863
70886285|NCT00667342|141258755|OTHER|The association between response and Vp at Week 10 was evaluated.||||||0.0573|||||||Logistic Regression|||||||0.0573
70886286|NCT00667342|141258756|OTHER|The association between response and Ve at Week 10 was evaluated.||||||0.0863|||||||Logistic Regression|||||||0.0863
70886287|NCT00835497|141258780|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|86.5||||||90.0|81.8|91.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||91.6|81.8|
70886288|NCT00835497|141258781|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|97.0||||||90.0|94.2|99.9|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.9|94.2|
70886289|NCT00835497|141258782|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|97.0||||||90.0|94.2|99.8|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.8|94.2|
70886290|NCT00835497|141258783|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|88.9||||||90.0|83.5|94.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||94.6|83.5|
70886291|NCT00835497|141258784|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|92.7||||||90.0|88.4|97.1|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||97.1|88.4|
70886292|NCT00835497|141258785|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|93.0||||||90.0|88.8|97.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||97.5|88.8|
70886293|NCT01573624|141258788|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.026||||0.264|TWO_SIDED|95.0|-0.019|0.071|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.071|-0.019|0.264
70886294|NCT01573624|141258788|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.033||||0.165|TWO_SIDED|95.0|-0.013|0.079|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.079|-0.013|0.165
70886295|NCT01573624|141258788|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.026||||0.271|TWO_SIDED|95.0|-0.02|0.071|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.071|-0.020|0.271
70886296|NCT01573624|141258788|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.055||||0.018|TWO_SIDED|95.0|0.01|0.1|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.100|0.010|0.018
70886297|NCT01573624|141258788|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.055||||0.018|TWO_SIDED|95.0|0.01|0.101|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.101|0.010|0.018
70886298|NCT01573624|141258788|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.078|||<|0.001|TWO_SIDED|95.0|0.032|0.124|||Mixed Models Analysis|||||0.124|0.032|<0.001
70886299|NCT01573624|141258788|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.052||||0.023|TWO_SIDED|95.0|-0.097|-0.007|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-0.007|-0.097|0.023
70886300|NCT01573624|141258788|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.045||||0.051|TWO_SIDED|95.0|-0.091|0.0|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.000|-0.091|0.051
70886301|NCT01573624|141258788|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.053||||0.023|TWO_SIDED|95.0|-0.098|-0.007|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-0.007|-0.098|0.023
70886302|NCT01573624|141258788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023||||0.306|TWO_SIDED|95.0|-0.068|0.021|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.021|-0.068|0.306
70886303|NCT01573624|141258788|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.023||||0.33|TWO_SIDED|95.0|-0.068|0.023|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.023|-0.068|0.330
70886304|NCT01573624|141258789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.9|||<|0.001|TWO_SIDED|95.0|9.5|22.3|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||22.3|9.5|<0.001
70886305|NCT01573624|141258789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.4|||<|0.001|TWO_SIDED|95.0|10.9|23.9|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||23.9|10.9|<0.001
70886306|NCT01573624|141258789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.6|||<|0.001|TWO_SIDED|95.0|12.1|25.1|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||25.1|12.1|<0.001
70886307|NCT01573624|141258789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.9|||<|0.001|TWO_SIDED|95.0|16.5|29.4|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||29.4|16.5|<0.001
70886308|NCT01573624|141258789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.0|||<|0.001|TWO_SIDED|95.0|15.5|28.4|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||28.4|15.5|<0.001
70886309|NCT01573624|141258789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.0|||<|0.001|TWO_SIDED|95.0|20.6|33.5|||Mixed Models Analysis|||||33.5|20.6|<0.001
70886310|NCT01573624|141258789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.2|||<|0.001|TWO_SIDED|95.0|-17.6|-4.7|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-4.7|-17.6|<0.001
70886311|NCT01573624|141258789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.6||||0.004|TWO_SIDED|95.0|-16.1|-3.1|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-3.1|-16.1|0.004
70886312|NCT01573624|141258789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.4||||0.012|TWO_SIDED|95.0|-14.9|-1.9|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-1.9|-14.9|0.012
70886313|NCT01573624|141258789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1||||0.209|TWO_SIDED|95.0|-10.6|2.3|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||2.3|-10.6|0.209
70886314|NCT01573624|141258789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.1||||0.124|TWO_SIDED|95.0|-11.6|1.4|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||1.4|-11.6|0.124
70886315|NCT01573624|141258790|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.2|||<|0.001|TWO_SIDED|95.0|9.5|22.9|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||22.9|9.5|<0.001
70886316|NCT01573624|141258790|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.2|||<|0.001|TWO_SIDED|95.0|10.5|24.0|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||24.0|10.5|<0.001
70886317|NCT01573624|141258790|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.2|||<|0.001|TWO_SIDED|95.0|14.4|28.0|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||28.0|14.4|<0.001
70886318|NCT01573624|141258790|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.8|||<|0.001|TWO_SIDED|95.0|22.1|35.5|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||35.5|22.1|<0.001
70886319|NCT01573624|141258790|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.9|||<|0.001|TWO_SIDED|95.0|16.2|29.6|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||29.6|16.2|<0.001
70886320|NCT01573624|141258790|SUPERIORITY_OR_OTHER||Mean Difference (Net)|26.6|||<|0.001|TWO_SIDED|95.0|19.8|33.4|||Mixed Models Analysis|||||33.4|19.8|<0.001
70886321|NCT01573624|141258790|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.3||||0.003|TWO_SIDED|95.0|-17.2|-3.5|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-3.5|-17.2|0.003
70886322|NCT01573624|141258790|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.3||||0.007|TWO_SIDED|95.0|-16.2|-2.5|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-2.5|-16.2|0.007
70886323|NCT01573624|141258790|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.4||||0.126|TWO_SIDED|95.0|-12.3|1.5|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||1.5|-12.3|0.126
70886324|NCT01573624|141258790|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2||||0.523||95.0|-4.6|9.1|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||9.1|-4.6|0.523
70886325|NCT01573624|141258790|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.7||||0.29|TWO_SIDED|95.0|-10.5|3.1|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||3.1|-10.5|0.290
70886326|NCT01573624|141258791|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.036|TWO_SIDED|95.0|-0.5|0.0|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.0|-0.5|0.036
70886327|NCT01573624|141258791|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.064|TWO_SIDED|95.0|-0.5|0.0|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.0|-0.5|0.064
70886328|NCT01573624|141258791|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.335|TWO_SIDED|95.0|-0.3|0.1|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.1|-0.3|0.335
70886329|NCT01573624|141258791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.012|TWO_SIDED|95.0|-0.5|-0.1|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||-0.1|-0.5|0.012
70886330|NCT01573624|141258791|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.023|TWO_SIDED|95.0|-0.5|0.0|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.0|-0.5|0.023
70886331|NCT01573624|141258791|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.7|-0.2|||Mixed Models Analysis|||||-0.2|-0.7|<0.001
70886332|NCT01573624|141258791|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.104|TWO_SIDED|95.0|0.0|0.4|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.4|0.0|0.104
70886333|NCT01573624|141258791|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.062|TWO_SIDED|95.0|0.0|0.5|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.5|0.0|0.062
70886334|NCT01573624|141258791|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.006|TWO_SIDED|95.0|0.1|0.6|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.6|0.1|0.006
70886335|NCT01573624|141258791|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.217|TWO_SIDED|95.0|-0.1|0.4|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.4|-0.1|0.217
70886336|NCT01573624|141258791|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.143|TWO_SIDED|95.0|-0.1|0.4|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.4|-0.1|0.143
70886337|NCT03037528|141258806|SUPERIORITY|||||||0.214|||||||t-test, 2 sided|||||||.214
70886338|NCT03037528|141258806|SUPERIORITY|||||||0.017|||||||t-test, 2 sided|||||||.017
70886339|NCT03037528|141258806|SUPERIORITY|||||||0.457|||||||t-test, 2 sided|||||||.457
70886340|NCT03037528|141258806|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||.580
70886341|NCT03037528|141258806|SUPERIORITY|||||||0.275|||||||t-test, 2 sided|||||||.275
70886342|NCT03037528|141258806|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||.001
70886343|NCT03037528|141258806|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||.007
70886344|NCT03037528|141258806|SUPERIORITY|||||||0.142|||||||t-test, 2 sided|||||||.142
70886345|NCT03037528|141258807|SUPERIORITY|||||||0.027|||||||t-test, 2 sided|||||||.027
70886346|NCT03037528|141258807|SUPERIORITY|||||||0|||||||t-test, 2 sided|||||||.000
70886347|NCT03037528|141258807|SUPERIORITY|||||||0.054|||||||t-test, 2 sided|||||||.054
70886348|NCT03037528|141258807|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||.014
70886349|NCT03037528|141258807|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||||||.019
70886350|NCT03037528|141258807|SUPERIORITY|||||||0.026|||||||t-test, 2 sided|||||||.026
70886351|NCT03037528|141258807|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||||||.013
70886352|NCT03037528|141258807|SUPERIORITY|||||||0.163|||||||t-test, 2 sided|||||||.163
70886353|NCT03037528|141258808|SUPERIORITY|||||||0.018|||||||t-test, 2 sided|||||||.018
70886354|NCT03037528|141258808|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||.004
70886355|NCT03037528|141258808|SUPERIORITY|||||||0.134|||||||t-test, 2 sided|||||||.134
70886356|NCT03037528|141258808|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
70886357|NCT03037528|141258808|SUPERIORITY|||||||0.048|||||||t-test, 2 sided|||||||.048
70886358|NCT03037528|141258808|SUPERIORITY|||||||0.066|||||||t-test, 2 sided|||||||.066
70886359|NCT03037528|141258808|SUPERIORITY|||||||0.045|||||||t-test, 2 sided|||||||.045
70886360|NCT03037528|141258808|SUPERIORITY|||||||0.053|||||||t-test, 2 sided|||||||.053
70886361|NCT00308711|141258819|SUPERIORITY_OR_OTHER||Kaplan-Meier|1595.5||||0.974||||||The a priori threshold for statistical significance was 0.05.|Log Rank||This was a Kaplan-Meier analysis of median time to vaginal delivery. Cervidil was compared separately to MVI 100 and MVI 50.|Null hypothesis was that there would be no difference in time to vaginal delivery for MVI 100 compared to time to vaginal delivery for Cervidil.||||0.974
70886362|NCT00308711|141258819|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1977.0||||0.011||95.0|1977.0|2253.0|||Log Rank|||||2253|1977|0.011
70886363|NCT00308711|141258820|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority (NI) margin was within 15% relative to the rate of cesarean section for the comparator (Cervidil 10 mg dinoprostone vaginal insert).|Cox Proportional Hazard|27.8||||0.64||95.0|23.61|32.31|||Fisher Exact|||||32.31|23.61|0.64
70886364|NCT00308711|141258820|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin was rate of cearean section within 15% of Cervidil rate.|Cox Proportional Hazard|28.0||||0.59||95.0|23.86|32.42|||Fisher Exact|||||32.42|23.86|0.59
70886365|NCT04590495|141258834|SUPERIORITY|||||||0.946|||||||Mann Whitney U Test|||||||0.9460
70886366|NCT04590495|141258835|SUPERIORITY|||||||0.5699|||||||Mann Whitney U Test|||||||0.5699
70886367|NCT04590495|141258836|SUPERIORITY|||||||0.6068|||||||t-test, 2 sided|||||||0.6068
70886368|NCT04590495|141258837|SUPERIORITY|||||||0.903|||||||Mann Whitney U Test|||||||0.9030
70886369|NCT04590495|141258838|SUPERIORITY|||||||0.2668|||||||t-test, 2 sided|||||||0.2668
70886370|NCT04590495|141258839|SUPERIORITY|||||||0.8749||||||adjusted for baseline VAMS score|paired t test|||||||0.8749
70886371|NCT04590495|141258840|SUPERIORITY|||||||0.7922||||||adjusted for baseline VAMS score for physical sedation|paired t test|||||||0.7922
70886372|NCT04590495|141258841|SUPERIORITY|||||||0.9925||||||adjusted for baseline SSS score|paired t test|||||||0.9925
70886373|NCT04590495|141258842|SUPERIORITY|||||||0.2628||||||adjusted for baseline score|paired t test|||||||0.2628
70886374|NCT04590495|141258843|SUPERIORITY|||||||0.0347||||||adjusted for baseline scores|paired t test|||||||0.0347
70886375|NCT04590495|141258844|SUPERIORITY|||||||0.6331||||||adjusted for baseline score|paired t test|||||||0.6331
70886376|NCT04590495|141258845|SUPERIORITY|||||||0.472||||||adjusted for baseline score|paired t test|||||||0.4720
70886377|NCT04590495|141258846|SUPERIORITY|||||||0.02||||||adjusted for baseline reaction time|paired t test|||||||0.0200
70886378|NCT04590495|141258847|SUPERIORITY|||||||0.062||||||adjusted for baseline reaction time|paired t test|||||||0.0620
70886379|NCT03591575|141258851|SUPERIORITY|||||||0.0446|||||||Fisher Exact|||Patients who reached the serum ferritin threshold at any time point prior to Month 12 were withdrawn from the study as per protocol, so that they could begin on standard chelation therapy. For these individuals, imputed data were used to estimate the values that would likely have been seen at Month 12 had they remained in the study.||||0.0446
70886380|NCT03591575|141258852|SUPERIORITY|||||||0.0446||||||he p-value shown here is for the difference between the groups at Month 12.|Fisher Exact|||||||0.0446
70886381|NCT01723228|141258853|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.8||||0.2204|TWO_SIDED|95.0|-0.48|2.05|||repeated measures model|The statistical model is a repeated measures model with visit by treatment interaction, center, baseline score, and age as fixed effects.||||2.05|-0.48|0.2204
70886382|NCT01723228|141258854|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.1||||0.8428|TWO_SIDED|95.0|-0.99|0.81|||Repeated Measures Model|The statistical model is a repeated measures model with visit by treatment interaction, center, baseline score, and age as fixed effects.||||0.81|-0.99|0.8428
70886383|NCT01723228|141258855|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.7||||0.4796|TWO_SIDED|95.0|-2.74|1.3|||ANCOVA|The statistical model is an analysis of covariance (ANCOVA) with treatment, center, baseline score, and age as fixed effects.||||1.30|-2.74|0.4796
70886384|NCT01723228|141258856|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.61||||0.1148|TWO_SIDED|95.0|0.89|2.93|||Proportional Odds Model|The statistical model is a proportional odds model with terms for treatment, center, and age.||CGIC||2.93|0.89|0.1148
70886385|NCT01723228|141258856|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1052|TWO_SIDED||||||Cochran-Mantel-Haenszel|For the Cochran-Mantel-Haenszel (CMH) p-value, the statistical model is a CMH test controlling for center with scores=modridit option.||CGIC||||0.1052
70886386|NCT01723228|141258856|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.96||||0.8857|TWO_SIDED|95.0|0.52|1.75|||Proportional Odds Model|The statistical model is a proportional odds model with terms for treatment, center, and age.||CGIC Cognition||1.75|0.52|0.8857
70886387|NCT01723228|141258856|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9945|TWO_SIDED|||||For the CMH p-value, the statistical model is a CMH test controlling for center with scores=modridit option.|Cochran-Mantel-Haenszel|||CGIC Cognition||||0.9945
70886388|NCT01723228|141258856|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.6909|TWO_SIDED|95.0|0.56|2.43|||Proportional Odds Model|The statistical model is a proportional odds model with terms for treatment, center, and age.||CGIC Behavior||2.43|0.56|0.6909
70886389|NCT01723228|141258856|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6639|TWO_SIDED||||||Cochran-Mantel-Haenszel|For the CMH p-value, the statistical model is a CMH test controlling for center with scores=modridit option.||CGIC Behavior||||0.6639
70886390|NCT01723228|141258856|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.39||||0.3204|TWO_SIDED|95.0|0.72|2.68|||Proportional Odds Model|The statistical model is a proportional odds model with terms for treatment, center, and age.||CGIC Functional Abilities||2.68|0.72|0.3204
70886391|NCT01723228|141258856|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3331|TWO_SIDED||||||Cochran-Mantel-Haenszel|For the CMH p-value, the statistical model is a CMH test controlling for center with scores=modridit option.||CGIC Functional Abilities||||0.3331
70886392|NCT01723228|141258857|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.5||||0.0151|TWO_SIDED|95.0|-4.47|-0.49|||Repeated Measures Model|The statistical model is a repeated measures model with visit by treatment interaction, center, baseline score, and age as fixed effects.||||-0.49|-4.47|0.0151
70886393|NCT01723228|141258858|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.3||||0.0003|TWO_SIDED|95.0|-3.53|-1.08|||Repeated Measures Model|The statistical model is a repeated measures model with visit by treatment interaction, center, baseline score, and age as fixed effects.||||-1.08|-3.53|0.0003
70886394|NCT00689481|141258870|SUPERIORITY_OR_OTHER|||||||0.016|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.016
70886395|NCT00689481|141258870|SUPERIORITY_OR_OTHER|||||||0.843|||||||Breslow-Day test|Breslow-Day test of the homogeneity of the odds ratio using a 0.1 significance level.||Consistency of results across investigative centers was verified using the Breslow-Day test of homogeneity the odds ration using a significance level of 0.1||||0.843
70886396|NCT00689481|141258871|SUPERIORITY_OR_OTHER|||||||0.034|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.034
70886397|NCT00689481|141258872|SUPERIORITY_OR_OTHER|||||||0.004||||||P-value is significant based on the Holm stepwise closed testing procedure to control multiplicity for the key secondary analyses if primary analysis was significant.|Cochran-Mantel-Haenszel|Stratified by pooled center.||||||0.004
70886398|NCT00689481|141258873|SUPERIORITY_OR_OTHER|||||||0.052|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.052
70886399|NCT00689481|141258874|SUPERIORITY_OR_OTHER|||||||0.033|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.033
70886400|NCT00689481|141258875|SUPERIORITY_OR_OTHER|||||||0.859|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||Comparison of calcipotriene foam and vehicle foam for patients who had mild disease at baseline||||0.859
70886401|NCT00689481|141258875|SUPERIORITY_OR_OTHER|||||||0.015|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||Comparison of calcipotriene foam and vehicle foam for patients who had moderate disease at baseline||||0.015
70886402|NCT02254278|141258876|SUPERIORITY|||||||0.04|||||||binomial|One-sided significance level=0.10||Assuming a binomial distribution, 140 eligible patients per arm were required for 80% power and 1-sided type I error rate of 10% to test the null hypothesis of 2-year progression-free survival (PFS) rate ≤ 85% against the alternative hypothesis of \> 85% with a binomial test. The arms are not compared to each other; they are each tested separately against the null hypothesis.||||0.04
70886403|NCT02254278|141258876|SUPERIORITY|||||||0.23|||||||bionmial|One-sided significance level = 0.10||Assuming a binomial distribution, 140 eligible patients per arm were required for 80% power and 1-sided type I error rate of 10% to test the null hypothesis of 2-year PFS rate ≤ 85% against the alternative hypothesis of \> 85% with a binomial test. The arms are not compared to each other; they are each tested separately against the null hypothesis.||||0.23
70886404|NCT02254278|141258877|SUPERIORITY||Hazard Ratio (HR)|0.39||||0.02|TWO_SIDED|95.0|0.17|0.9|||Log Rank|Two-sided significance level = 0.05|Reference level = IMRT 5 weeks|||0.90|0.17|0.02
70886405|NCT02254278|141258878|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.58|TWO_SIDED|95.0|0.4|5.08|||Log Rank|Two-sided significance level = 0.05|Reference level = IMRT 5 weeks|||5.08|0.4|0.58
70886406|NCT02254278|141258879|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.93|TWO_SIDED|95.0|0.31|2.95||Two-side significance level = 0.05|Log Rank||Reference level = IMRT 5 weeks|||2.95|0.31|0.93
70886407|NCT02254278|141258880|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|Two-sided significance level = 0.05||End of RT||||<0.0001
70886408|NCT02254278|141258880|SUPERIORITY|||||||0.17|||||||Fisher Exact|Two-sided significance level = 0.05||One month after end of RT||||0.17
70886409|NCT02254278|141258880|SUPERIORITY|||||||0.16|||||||Fisher Exact|Two-side significance level = 0.05||Six months after end of RT||||0.16
70886410|NCT02254278|141258880|SUPERIORITY|||||||0.26|||||||Fisher Exact|Two-side significance level = 0.05||One year after end of RT||||0.26
70886411|NCT02254278|141258880|SUPERIORITY|||||||0.82|||||||Fisher Exact|Two-side significance level = 0.05||Two years after the end of RT||||0.82
70886412|NCT02254278|141258882|SUPERIORITY|||||||0.3|||||||binomial test|One-sided significance level = 0.10||Progression-free survival: The null hypothesis of negative predictive value ≤ 90% was tested against the alternative of \> 90% with a 1-sided binomial test at the 0.10 level.||||0.3
70886413|NCT02254278|141258882|SUPERIORITY|||||||0.07|||||||binomial test|One-sided significance level = 0.10||Local-regional control: The null hypothesis of negative predictive value ≤ 90% was tested against the alternative of \> 90% with a 1-sided binomial test at the 0.10 level.||||0.07
70886414|NCT02254278|141258883|SUPERIORITY|||||||0.28|||||||Fisher Exact|Two-sided significance level = 0.05||||||0.28
70886415|NCT02254278|141258884|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|Two-sided significance level = 0.05||||||0.03
70886416|NCT02254278|141258888|SUPERIORITY|||||||0.08|||||||Fisher Exact|Two-sided significance level = 0.05||||||0.08
70886417|NCT02254278|141258889|SUPERIORITY|||||||0.02||||||Two-sided significance level = 0.05|Fisher Exact|||||||0.02
70886418|NCT03091192|141258906|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.313|TWO_SIDED|95.0|0.37|1.36|||Log Rank|||||1.36|0.37|0.313
70886419|NCT03091192|141258907|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.11|TWO_SIDED|95.0|0.21|1.17|||Log Rank||A hazard ratio \< 1 favours Savolitinib|||1.17|0.21|0.110
70886420|NCT04487080|141258929|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0002|TWO_SIDED|95.0|0.58|0.85|||Log Rank||HR and its 95% CI was estimated based on a stratified Cox's regression model with treatment as the sole explanatory variable.|||0.85|0.58|0.0002
70886421|NCT01706952|141258991|SUPERIORITY_OR_OTHER|For surgical field grade, we calculated the mean within sides and assessed its difference, reporting a 95% confidence interval as calculated by a Student t test. We used the average per patient over time.||||||0.05|||||||t-test, 2 sided|||Data analysis was performed using SPSS version 13 for Windows (SPSS Inc, Chicago, IL). A power study was per formed with a power of 80% and a clinically significant difference in bleeding between the sides of 20% with a significance level of 5% (p \< 0.05).|"For the primary objective of surgical field grade, we calculated the mean within sides treated with cocaine vs adrenaline and assessed its difference, reporting a 95% con- fidence interval as calculated by a Student t test. As all of these values were measured over time, we used the average per patient over time. The total blood loss per side within subjects was also calculated, with 95% confidence interval again calculated by a Student t test. Once again, we took the average per patient over time as the main outcome.~Finally, we used a linear regression with surgical field improvement as the outcome and HR, MAP, or etCO2 as covariates, to investigate which variables may be related to the outcome. As these measures were taken over time, we used repeated measures analysis to investigate how these items correlate over time.~In addition to the operating surgeon, the statistician was blinded to the vasoconstrictor allocation."|||0.05
70886422|NCT02453113|141259000|SUPERIORITY||||||||||||||||||The statistical end point of the study will be the changes in density of CD11c+ dermal dendritic cells between two biopsies from a study subject where one sample is subjected to laser irradiation and the other is the control. For assessment of statistical significance, we will apply a paired sample t-test.|||
70886423|NCT02896400|141259013|SUPERIORITY||Odds Ratio (OR)|1.8||||0.01|TWO_SIDED|95.0|1.1|2.8|||Regression, Logistic|Adjusted for gender, age, race/ethnicity, baseline daily cigarette consumption||8 arms including BNI (BNI only, BNI+NRT, BNI+QL, BNI+Text, BNI+NRT+QL, BNI+NRT+Text, BNI+QL+Text, BNI+NRT+QL+Text) compared to the 8 arms that do not include BNI (Control, NRT only, QL only, Text only, NRT+QL, NRT+Text, QL+Text, NRT+QL+Text)||2.8|1.1|.01
70886424|NCT02896400|141259013|SUPERIORITY||Odds Ratio (OR)|2.1||||0.001|TWO_SIDED|95.0|1.3|3.2|||Regression, Logistic|adjusted for gender, age, race/ethnicity, baseline daily cigarette consumption||8 arms that include NRT (NRT only, BNI+NRT, NRT+QL, NRT+Text, BNI+NRT+QL, BNI+NRT+Text, NRT+QL+Text, BNI+NRT+QL+Text) compared to 8 arms that do not include NRT (Control, BNI only, QL only, Text only, BNI+QL, BNI+Text, QL+Text, BNI+QL+Text)||3.2|1.3|.001
70886425|NCT02896400|141259013|SUPERIORITY||Odds Ratio (OR)|1.4||||0.14|TWO_SIDED|95.0|0.9|2.2|||Regression, Logistic|adjusted for gender, age, race/ethnicity, baseline daily cigarette consumption||8 arms including QL intervention (QL only, BNI+QL, NRT+QL, QL+Text, BNI+NRT+QL, BNI+QL+Text, NRT+QL+Text, BNI+NRT+QL+Text) compared to all 8 arms that did not include QL (Control, BNI only, NRT only, Text only, BNI+NRT, BNI+Text, NRT+Text, BNI+NRT+Text)||2.2|0.9|0.14
70886426|NCT02896400|141259013|SUPERIORITY||Odds Ratio (OR)|1.1||||0.64|TWO_SIDED|95.0|0.7|1.7|||Regression, Logistic|adjusted for gender, age, race/ethnicity, baseline daily cigarette consumption||8 arms including Text (Text only, BNI+Text, NRT+Text, QL+Text, BNI+NRT+Text, BNI+QL+Text, NRT+QL+Text, BNI+NRT+QL+Text) compared to 8 arms that do not include Text (Control, BNI only, NRT only, QL only, BNI+NRT, BNI+QL, NRT+QL, BNI+NRT+QL)||1.7|0.7|0.64
70886427|NCT01221441|141259035|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Denominator degrees of freedom were adjusted using the Kenward-Roger's method.||"The primary efficacy evaluation based on IKDC and the VAS were tested at week 52 evaluated 100 mm VAS with the following superiority hypothesis:~HO: μTG = μPC vs. HA: μTG ≠ μPC, where μTG and μPC are the mean change from baseline in IKDC or VAS scores at week 52 for patients in the TG-C and placebo control groups, respectively. If the null hypotheses for both the IKDC and the VAS are rejected, it the clinical effect of TG-C is concluded to be superior to that of the control."||||<0.01
70886428|NCT01221441|141259036|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Denominator degrees of freedom were adjusted using the Kenward-Roger's method.||"The primary efficacy evaluation based on IKDC and the VAS were tested at week 52 evaluated 100 mm VAS with the following superiority hypothesis:~HO: μTG = μPC vs. HA: μTG ≠ μPC, where μTG and μPC are the mean change from baseline in IKDC or VAS scores at week 52 for patients in the TG-C and placebo control groups, respectively. If the null hypotheses for both the IKDC and the VAS are rejected, it the clinical effect of TG-C is concluded to be superior to that of the control."||||<0.01
70886429|NCT01221441|141259037|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Denominator degrees of freedom were adjusted using the Kenward-Roger's method.||"The efficacy evaluation at week 104 evaluated KOOS with the following superiority hypothesis:~HO: μTG = μPC vs. HA: μTG ≠ μPC, where μTG and μPC are the mean change from baseline in KOOS scores at week 104 for patients in the TG-C and placebo control groups, respectively. If the null hypotheses for KOOS is rejected, it the clinical effect of TG-C is concluded to be superior to that of the control."||||<0.01
70886430|NCT01221441|141259038|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Denominator degrees of freedom were adjusted using the Kenward-Roger's method.||"The efficacy evaluation at week 104 evaluated Lysholm score with the following superiority hypothesis:~HO: μTG = μPC vs. HA: μTG ≠ μPC, where μTG and μPC are the mean change from baseline in KOOS scores at week 104 for patients in the TG-C and placebo control groups, respectively. If the null hypotheses for Lysholm score is rejected, it the clinical effect of TG-C is concluded to be superior to that of the control."||||<0.01
70886431|NCT02665481|141259051|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.5|TWO_SIDED|95.0|-0.15|0.07|||Marginal Model|||Time x MBSR (Month 0 and Month 6)||0.07|-0.15|0.50
70886432|NCT02665481|141259051|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.18|TWO_SIDED|95.0|-0.04|0.19|||Marginal Model|||Time x MBSR (Month 0 and Month 18)||0.19|-0.04|0.18
70886433|NCT02665481|141259051|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.23|TWO_SIDED|95.0|-0.04|0.17|||Marginal Model|||Time x Exercise (Month 0 and Month 6)||0.17|-0.04|0.23
70886434|NCT02665481|141259051|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.47|TWO_SIDED|95.0|-0.15|0.07|||Marginal Model|||Time x Exercise (Month 0 and Month 18)||0.07|-0.15|0.47
70886435|NCT02665481|141259052|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.12|TWO_SIDED|95.0|-0.02|0.19|||Marginal Model|||Time x MBSR (Month 0 and Month 6)||0.19|-0.02|0.12
70886436|NCT02665481|141259052|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.44|TWO_SIDED|95.0|-0.15|0.07|||Marginal Model|||Time x MBSR (Month 0 and Month 18)||0.07|-0.15|0.44
70886437|NCT02665481|141259052|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.17|TWO_SIDED|95.0|-0.03|0.18|||Marginal Model|||Time x Exercise (Month 0 and Month 6)||0.18|-0.03|0.17
70886438|NCT02665481|141259052|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.93|TWO_SIDED|95.0|-0.12|0.11|||Marginal Model|||Time x Exercise (Month 0 and Month 18).||0.11|-0.12|0.93
70886439|NCT02665481|141259053|SUPERIORITY||Mean Difference (Final Values)|-3.46||||0.53|TWO_SIDED|95.0|-14.27|7.34|||Marginal Model|||Time x MBSR (Month 0 and Month 6)||7.34|-14.27|0.53
70886440|NCT02665481|141259053|SUPERIORITY||Mean Difference (Final Values)|-20.16||||0.004|TWO_SIDED|95.0|-33.88|-6.44|||Marginal Model|||Time x MBSR (Month 0 and Month 18).||-6.44|-33.88|0.004
70886441|NCT02665481|141259053|SUPERIORITY||Mean Difference (Final Values)|3.04||||0.58|TWO_SIDED|95.0|-7.76|13.85|||Marginal Model|||Time x Exercise (Month 0 and Month 6)||13.85|-7.76|0.58
70886442|NCT02665481|141259053|SUPERIORITY||Mean Difference (Final Values)|-6.26||||0.37|TWO_SIDED|95.0|-19.98|7.46|||Marginal Model|||Time x Exercise (Month 0 and Month 18).||7.46|-19.98|0.37
70886443|NCT02665481|141259054|SUPERIORITY||Mean Difference (Final Values)|22.71||||0.33|TWO_SIDED|95.0|-22.95|68.36|||Marginal Model|||Time x MBSR (Month 0 and Month 6)||68.36|-22.95|0.33
70886444|NCT02665481|141259054|SUPERIORITY||Mean Difference (Final Values)|25.35||||0.31|TWO_SIDED|95.0|-23.18|73.88|||Marginal Model|||Time x MBSR (Month 0 and Month 18)||73.88|-23.18|0.31
70886445|NCT02665481|141259054|SUPERIORITY||Mean Difference (Final Values)|-17.18||||0.46|TWO_SIDED|95.0|-62.83|28.48|||Marginal Model|||Time x Exercise (Month 0 and Month 6).||28.48|-62.83|0.46
70886446|NCT02665481|141259054|SUPERIORITY||Mean Difference (Final Values)|21.11||||0.39|TWO_SIDED|95.0|-27.41|69.64|||Marginal Model|||Time x Exercise (Month 0 and Month 18).||69.64|-27.41|0.39
70886447|NCT02665481|141259055|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.37|TWO_SIDED|95.0|-0.02|0.01|||Marginal Model|||Time x MBSR (Month 0 and Month 6).||0.01|-0.02|0.37
70886448|NCT02665481|141259055|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.1|TWO_SIDED|95.0|-0.02|0.0|||Marginal Model|||Time x MBSR (Month 0 and Month 18).||0.00|-0.02|0.10
70886449|NCT02665481|141259055|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.21|TWO_SIDED|95.0|-0.004|0.02|||Marginal Model|||Time x Exercise (Month 0 and Month 6).||0.02|-0.004|0.21
70886450|NCT02665481|141259055|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.09|TWO_SIDED|95.0|-0.02|0.0|||Marginal Model|||Time x Exercise (Month 0 and Month 18).||0.00|-0.02|0.09
70886451|NCT02665481|141259056|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.57|TWO_SIDED|95.0|-0.38|0.69|||Marginal Model|||Time x MBSR (Month 0 and Month 6)||0.69|-0.38|0.57
70886452|NCT02665481|141259056|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.96|TWO_SIDED|95.0|-0.58|0.55|||Marginal Model|||Time x MBSR (Month 0 and Month 18).||0.55|-0.58|0.96
70886453|NCT02665481|141259056|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.37|TWO_SIDED|95.0|-0.78|0.29|||Marginal Model|||Time x Exercise (Month 0 and Month 6).||0.29|-0.78|0.37
70886454|NCT02665481|141259056|SUPERIORITY||Mean Difference (Final Values)|-0.003||||0.99|TWO_SIDED|95.0|-0.57|0.57|||Marginal Model|||Time x Exercise (Month 0 and Month 18).||0.57|-0.57|0.99
70886455|NCT02665481|141259057|SUPERIORITY||Mean Difference (Final Values)|0.93||||0.19|TWO_SIDED|95.0|-0.47|2.33|||Marginal Model|||Time x MBSR (Month 0 and Month 6).||2.33|-0.47|0.19
70886456|NCT02665481|141259057|SUPERIORITY||Mean Difference (Final Values)|1.29||||0.09|TWO_SIDED|95.0|-0.19|2.77|||Marginal Model|||Time x MBSR (Month 0 and Month 18).||2.77|-0.19|0.09
70886457|NCT02665481|141259057|SUPERIORITY||Mean Difference (Final Values)|-0.57||||0.42|TWO_SIDED|95.0|-1.97|0.83|||Marginal Model|||Time x Exercise (Month 0 and Month 6).||0.83|-1.97|0.42
70886458|NCT02665481|141259057|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.54|TWO_SIDED|95.0|-1.01|1.94|||Marginal Model|||Time x Exercise (Month 0 and Month 18).||1.94|-1.01|0.54
70886459|NCT00494494|141259116|NON_INFERIORITY_OR_EQUIVALENCE|Our estimate of a clinically relevant increase is 25 microns. With these specifications, the sample size that is required to have 0.90 power for the comparison between two groups at the two-sided 0.05 significance level is about 10 per group.|Mean Difference (Net)|2.82|STANDARD_DEVIATION|13.8||0.7029|TWO_SIDED|95.0|-3.27|8.91|||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no correlation between the 2 groups. Standard methods were used for power calculation to determine the sample size needed to have 0.90 power for the comparison between two groups at the two-sided significance of 0.05.||8.91|-3.27|0.7029
70886460|NCT00494494|141259117|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.01|STANDARD_DEVIATION|9.56||0.1937|TWO_SIDED|95.0|-2.41|6.43|||Wilcoxon (Mann-Whitney)|||||6.43|-2.41|0.1937
70886461|NCT00494494|141259118|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.7|STANDARD_DEVIATION|19.6||0.5066|TWO_SIDED|95.0|-3.12|16.52|||Wilcoxon (Mann-Whitney)|||||16.52|-3.12|0.5066
70886462|NCT00494494|141259119|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.21||0.5099|TWO_SIDED|95.0|-0.13|0.227|||Wilcoxon (Mann-Whitney)|||||0.227|-0.13|0.5099
70886463|NCT00494494|141259120|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.03|STANDARD_DEVIATION|5.64||0.5005|TWO_SIDED|95.0|-1.49|3.55|||Wilcoxon (Mann-Whitney)|||||3.55|-1.49|0.5005
70886464|NCT01502644|141259141|OTHER||Mean Difference (Net)|18.0||||0.01|TWO_SIDED|95.0|3.7|32.2|||Linear Mixed Modeling|Group, group×week, average baseline pain, and opioid use at baseline were entered as fixed effects using an autoregressive covariance structure.||||32.2|3.7|0.01
70886465|NCT02388997|141259157|SUPERIORITY|||||||0.59|||||||2-sample t-test with unequal variences|||||||0.59
70886466|NCT02388997|141259158|SUPERIORITY|||||||0.58|||||||2-sample t-test with unequal variances|||||||0.58
70886467|NCT02388997|141259159|SUPERIORITY|||||||0.87|||||||2-sample t-test with unequal variances|||||||0.87
70886468|NCT02388997|141259160|SUPERIORITY|||||||0.55|||||||2-sample t-test with unequal variances|||||||0.55
70886469|NCT02388997|141259161|SUPERIORITY|||||||0.6|||||||2-sample t-test with unequal variances|||||||0.6
70886470|NCT02388997|141259163|SUPERIORITY|||||||0.037||||||The p value is based on the fold change (ratio) of the geometric means of the time (days) to peak symptoms among asthmatics in the omalizumab/placebo treatment groups.|2-sample t-test on the log scale|||||||0.037
70886471|NCT01559311|141259177|SUPERIORITY_OR_OTHER|||||||0.1734|||||||Wilcoxon (Mann-Whitney)|||"* H01: μ LVEF, 1= μ LVEF, 2a vs H1a: μ LVEF, 1 \< μ LVEF, 2a~* Where μ LVEF, 1 is the mean of LVEF at month 12 in DDDR Gp.~* μ LVEF, 2a is the mean of LVEF at month 12 in CRT-P ON Gp,"||||0.1734
70886472|NCT01559311|141259177|SUPERIORITY_OR_OTHER|||||||0.1439|||||||Wilcoxon (Mann-Whitney)|||"* H03: μ LVEF, 1= μ LVEF, 2b vs H1a: μ LVEF, 1 \< μ LVEF, 2b~* Where μ LVEF, 1 is the mean of LVEF at month 12 in DDDR Gp.~* μ LVEF, 2b is the mean of LVEF at month 12 in the CRT-P OFF Gp"||||0.1439
70886473|NCT01559311|141259178|SUPERIORITY_OR_OTHER|||||||0.6276|||||||Wilcoxon (Mann-Whitney)|||"* H02: μ LVESV, 1 = μ LVESV, 2a vs H1b: μ LVESV, 1 \> μ LVESV, 2a~* Where, μLVESV, 1 is the mean of LVESV at month 12 in the DDDR Group,~* μLVESV, 2a is the mean of LVESV at month 12 in the CRT-P ON group"||||0.6276
70886474|NCT01559311|141259178|SUPERIORITY_OR_OTHER|||||||0.5871|||||||Wilcoxon (Mann-Whitney)|||"* H04: μ LVESV, 1 = μ LVESV, 2b vs H1b: μ LVESV, 1 \> μ LVESV, 2b~* Where, μLVESV, 1 is the mean of LVESV at month 12 in the DDDR Group,~* and μLVESV, 2b is the mean of LVESV at month 12 in CRT-P OFF group."||||0.5871
70886475|NCT02346240|141259189|SUPERIORITY||Estimated difference in responder rate|61.6|||||TWO_SIDED|95.0|52.1|71.2|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||71.2|52.1|
70886476|NCT02346240|141259189|SUPERIORITY||Estimated difference in responder rate|56.2|||||TWO_SIDED|95.0|46.4|66.0|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||66.0|46.4|
70886477|NCT02346240|141259189|SUPERIORITY||Odds Ratio (OR)|37.988|||<|0.0001|TWO_SIDED|95.0|11.312|127.576||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO.|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||127.576|11.312|<0.0001
70886478|NCT02346240|141259189|SUPERIORITY||Odds Ratio (OR)|30.023|||<|0.0001|TWO_SIDED|95.0|8.971|100.481||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO.|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||100.481|8.971|<0.0001
70886479|NCT02346240|141259189|SUPERIORITY||Estimated difference in responder rate|13.4|||||TWO_SIDED|95.0|2.7|24.1|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure|Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Etanercept Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||24.1|2.7|
70886480|NCT02346240|141259189|SUPERIORITY||Estimated difference in responder rate|8.0|||||TWO_SIDED|95.0|-2.9|18.9|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Etanercept Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||18.9|-2.9|
70886481|NCT02346240|141259189|SUPERIORITY||Odds Ratio (OR)|1.756|||=|0.0152|TWO_SIDED|95.0|1.114|2.768||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. ETN.|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||2.768|1.114|=0.0152
70886482|NCT02346240|141259189|SUPERIORITY||Odds Ratio (OR)|1.388|||=|0.1523|TWO_SIDED|95.0|0.886|2.175||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. ETN|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||2.175|0.886|=0.1523
70886483|NCT02346240|141259190|SUPERIORITY||Estimated difference in responder rate|48.5|||||TWO_SIDED|95.0|39.33|57.63|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||57.63|39.33|
70886484|NCT02346240|141259190|SUPERIORITY||Estimated difference in responder rate|37.9|||||TWO_SIDED|95.0|28.88|46.96|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||46.96|28.88|
70886485|NCT02346240|141259190|SUPERIORITY||Odds Ratio (OR)|56.129|||<|0.0001|TWO_SIDED|95.0|7.787|404.555||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||404.555|7.787|<0.0001
70886486|NCT02346240|141259190|SUPERIORITY||Odds Ratio (OR)|36.566|||=|0.0004|TWO_SIDED|95.0|5.061|264.196||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||264.196|5.061|=0.0004
70886487|NCT02346240|141259191|SUPERIORITY||Estimated difference in responder rate|33.8|||||TWO_SIDED|95.0|20.68|46.98|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||46.98|20.68|
70886488|NCT02346240|141259191|SUPERIORITY||Estimated difference in responder rate|31.0|||||TWO_SIDED|95.0|18.18|43.8|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||43.80|18.18|
70886489|NCT02346240|141259191|SUPERIORITY||Odds Ratio (OR)|39.949|||<|0.0001|TWO_SIDED|95.0|8.407|189.828||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||189.828|8.407|<0.0001
70886490|NCT02346240|141259191|SUPERIORITY||Odds Ratio (OR)|35.084|||<|0.0001|TWO_SIDED|95.0|7.363|167.179||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||167.179|7.363|<0.0001
70886491|NCT02346240|141259192|SUPERIORITY||Estimated difference in responder rate|70.9|||||TWO_SIDED|95.0|62.15|79.59|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||79.59|62.15|
70886492|NCT02346240|141259192|SUPERIORITY||Estimated difference in responder rate|64.4|||||TWO_SIDED|95.0|55.12|73.63|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||73.63|55.12|
70886493|NCT02346240|141259192|SUPERIORITY||Odds Ratio (OR)|76.277|||<|0.0001|TWO_SIDED|95.0|17.952|324.094||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||324.094|17.952|<0.0001
70886494|NCT02346240|141259192|SUPERIORITY||Odds Ratio (OR)|55.413|||<|0.0001|TWO_SIDED|95.0|13.135|233.782||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||233.782|13.135|<0.0001
70886495|NCT02346240|141259193|SUPERIORITY||Estimated difference in responder rate|55.0|||||TWO_SIDED|95.0|45.59|64.35|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||64.35|45.59|
70886496|NCT02346240|141259193|SUPERIORITY||Estimated difference in responder rate|44.9|||||TWO_SIDED|95.0|35.39|54.49|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||54.49|35.39|
70886497|NCT02346240|141259193|SUPERIORITY||Odds Ratio (OR)|40.717|||<|0.0001|TWO_SIDED|95.0|9.741|170.198||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||170.198|9.741|<0.0001
70886498|NCT02346240|141259193|SUPERIORITY||Odds Ratio (OR)|27.165|||<|0.0001|TWO_SIDED|95.0|6.504|113.453||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||113.453|6.504|<0.0001
70886499|NCT02346240|141259194|SUPERIORITY||Estimated difference in responder rate|48.8|||||TWO_SIDED|95.0|34.22|63.41|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||63.41|34.22|
70886500|NCT02346240|141259194|SUPERIORITY||Estimated difference in responder rate|39.5|||||TWO_SIDED|95.0|25.58|53.38|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||53.38|25.58|
70886501|NCT02346240|141259194|SUPERIORITY||Odds Ratio (OR)|72.278|||<|0.0001|TWO_SIDED|95.0|14.65|356.602||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||356.602|14.650|<0.0001
70886502|NCT02346240|141259194|SUPERIORITY||Odds Ratio (OR)|49.527|||<|0.0001|TWO_SIDED|95.0|10.002|245.256||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||245.256|10.002|<0.0001
70886503|NCT00554749|141259196|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.09|STANDARD_DEVIATION|0.43|<|0.001||95.0|1.69|2.49|||paired t-test|Paired t-test of SSQ at baseline vs at 6 months, degrees of freedom=6. Difference in SSQ is reported.||||2.49|1.69|<0.001
70886504|NCT03417141|141259198|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||Week 12||||0.014
70886505|NCT03417141|141259198|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||Week 24||||0.006
70886506|NCT03417141|141259199|SUPERIORITY|||||||0.093|||||||Wilcoxon (Mann-Whitney)|||||||0.093
70886507|NCT03417141|141259200|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
70886508|NCT03417141|141259201|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
70886509|NCT03706690|141259208|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.038|TWO_SIDED|95.0|0.578|0.986|||Log Rank|Analysis performed using stratified log-rank test, adjusting for the level of PD-L1 expression and prior therapy (cCRT vs sCRT).||The hazard ratio and confidence intervals (CIs) were calculated using a stratified Cox proportional hazards model, adjusting for the level of programmed death ligand 1 (PD-L1) expression (PD-L1 \<1% versus \[vs\] PD-L1 \>=1%) and prior therapy (concurrent \[c\]CRT vs sequential \[s\]CRT), with treatment as the only covariate and ties handled by Efron approach.||0.986|0.578|0.038
70886510|NCT03706690|141259209|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.346|TWO_SIDED|95.0|0.656|1.166|||Log Rank|Analysis performed using stratified log-rank test, adjusting for level of PD-L1 expression and prior therapy (cCRT vs. sCRT).||For mITT set. The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs PD-L1 \>=1%) and prior therapy (cCRT vs sCRT), with treatment as the only covariate and ties handled by Efron approach.||1.166|0.656|0.346
70886511|NCT03706690|141259209|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.346|TWO_SIDED|95.0|0.663|1.162|||Log Rank|Analysis performed using stratified log-rank test, adjusting for level of PD-L1 expression and prior therapy (cCRT vs. sCRT).||For ITT set. The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs PD-L1 \>=1%) and prior therapy (cCRT vs sCRT), with treatment as the only covariate and ties handled by Efron approach.||1.162|0.663|0.346
70886512|NCT03706690|141259210|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.026|TWO_SIDED|95.0|0.575|0.966|||Log Rank|Analysis performed using stratified log-rank test, adjusting for the level of PD-L1 expression and prior therapy (cCRT vs sCRT).||The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs PD-L1\>=1%) and prior therapy (cCRT vs sCRT), with treatment as the only covariate and ties handled by Efron approach.||0.966|0.575|0.026
70886513|NCT03706690|141259212|SUPERIORITY||Odds Ratio (OR)|1.51||||0.128|TWO_SIDED|95.0|0.891|2.607|||Regression, Logistic|||For mITT set. The comparison was performed using a logistic regression model, with treatment as a covariate and adjusting for the level of PD-L1 expression (PD-L1 \<1% vs. PD-L1 \>=1%) and prior therapy (cCRT vs. sCRT), with 95% CI calculated by profile likelihood.||2.607|0.891|0.128
70886514|NCT03706690|141259212|SUPERIORITY||Odds Ratio (OR)|1.54||||0.105|TWO_SIDED|95.0|0.915|2.638|||Regression, Logistic|||For ITT set. The comparison was performed using a logistic regression model, with treatment as a covariate and adjusting for the level of PD-L1 expression (PD-L1 \<1% vs. PD-L1 \>=1%) and prior therapy (cCRT vs. sCRT), with 95% CI calculated by profile likelihood.||2.638|0.915|0.105
70886515|NCT03706690|141259215|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.275|TWO_SIDED|95.0|0.648|1.138|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for the level of PD-L1 expression and prior therapy (cCRT vs. sCRT).||For mITT set. The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs. PD-L1 \>=1%) and prior therapy (cCRT vs. sCRT), with treatment as the only covariate and ties handled by Efron approach.||1.138|0.648|0.275
70886516|NCT03706690|141259215|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.241|TWO_SIDED|95.0|0.648|1.122|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for the level of PD-L1 expression and prior therapy (cCRT vs. sCRT).||For ITT set. The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs. PD-L1 \>=1%) and prior therapy (cCRT vs. sCRT), with treatment as the only covariate and ties handled by Efron approach.||1.122|0.648|0.241
70886517|NCT03706690|141259216|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.769|TWO_SIDED|95.0|0.726|1.578|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for the level of PD-L1 expression and prior therapy (cCRT vs. sCRT).||For mITT set. The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs. PD-L1 \>=1%) and prior therapy (cCRT vs. sCRT), with treatment as the only covariate and ties handled by Efron approach.||1.578|0.726|0.769
70886518|NCT03706690|141259216|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.812|TWO_SIDED|95.0|0.726|1.539|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for the level of PD-L1 expression and prior therapy (cCRT vs. sCRT).||For ITT set. The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs. PD-L1 \>=1%) and prior therapy (cCRT vs. sCRT), with treatment as the only covariate and ties handled by Efron approach.||1.539|0.726|0.812
70886519|NCT03467425|141259297|SUPERIORITY||Odds Ratio (OR)|1.31|||<|0.001|TWO_SIDED|95.0|1.13|1.51||Analysis was performed using logistic regression model with covariates of treatment group, Baseline CAT score, number of exacerbations in the prior year, actual prior medication use strata and country.|Regression, Logistic||Statistical comparison is presented for combined data of responders, non-responders and those with imputed CAT score at Week 24.|||1.51|1.13|<0.001
70886520|NCT03467425|141259298|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.0121|<|0.001|TWO_SIDED|95.0|0.026|0.073|||ANCOVA||Analysis was performed using an ANCOVA with covariates of treatment group, Baseline FEV1, actual prior medication use strata, country and timing of spirometry.|||0.073|0.026|<0.001
70886521|NCT03467425|141259299|SUPERIORITY||Odds Ratio (OR)|1.99||||0.103|TWO_SIDED|95.0|0.87|4.53|||Regression, Logistic||Analysis was performed using logistic regression model with covariates of treatment group, actual prior medication use strata and country.|||4.53|0.87|0.103
70886522|NCT02318693|141259302|SUPERIORITY_OR_OTHER||LS Means Difference|-8.8||||0.245|TWO_SIDED|95.0|-23.8|6.2|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||The comparison was conducted at the α=0.05 (2-sided) significance level.||6.2|-23.8|0.245
70886523|NCT02318693|141259303|SUPERIORITY_OR_OTHER||LS Means Difference|-5.9||||0.029|TWO_SIDED|95.0|-11.3|-0.6|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||The comparison was conducted at the α=0.05 (2-sided) significance level.||-0.6|-11.3|0.029
70886524|NCT02318693|141259304|SUPERIORITY_OR_OTHER||LS Means Difference|-12.8||||0.041|TWO_SIDED|95.0|-25.1|-0.5|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||Comparison: Change from Baseline in Maximum Incremental Postprandial Glucose Levels at Breakfast. The comparison was conducted at the α=0.05 (2-sided) significance level.||-0.5|-25.1|0.041
70886525|NCT02318693|141259304|SUPERIORITY_OR_OTHER||LS Means Difference|-14.3||||0.043|TWO_SIDED|95.0|-28.1|-0.5|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||Comparison: Change from Baseline in Maximum Incremental Postprandial Glucose Levels at Lunch. The comparison was conducted at the α=0.05 (2-sided) significance level.||-0.5|-28.1|0.043
70886526|NCT02318693|141259304|SUPERIORITY_OR_OTHER||LS Means Difference|5.1||||0.509|TWO_SIDED|95.0|-10.3|20.4|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||Comparison: Change from Baseline in Maximum Incremental Postprandial Glucose Levels at Dinner. The comparison was conducted at the α=0.05 (2-sided) significance level.||20.4|-10.3|0.509
70886527|NCT02318693|141259305|SUPERIORITY_OR_OTHER||LS Means Difference|15.7||||0.02|TWO_SIDED|95.0|2.5|28.8|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||The comparison was conducted at the α=0.05 (2-sided) significance level.||28.8|2.5|0.020
70886528|NCT02318693|141259306|SUPERIORITY_OR_OTHER||LS Means Difference|-1.1||||0.134|TWO_SIDED|95.0|-2.5|0.3|||constrained longitudinal analysis model|||Comparison: Change in Baseline in Percentage of Hypoglycemic Values \< 70 mg/dL. The comparison was conducted at the α=0.05 (2-sided) significance level.||0.3|-2.5|0.134
70886529|NCT02318693|141259306|SUPERIORITY_OR_OTHER||LS Means Difference|-0.6||||0.226|TWO_SIDED|95.0|-1.5|0.4|||constrained longitudinal analysis model|||Comparison: Change in Baseline in Percentage of Hypoglycemic Values \< 60 mg/dL. The comparison was conducted at the α=0.05 (2-sided) significance level.||0.4|-1.5|0.226
70886530|NCT02318693|141259306|SUPERIORITY_OR_OTHER||LS Means Difference|0.0||||0.332|TWO_SIDED|95.0|-0.1|0.0|||constrained longitudinal analysis model|||Comparison: Change in Baseline in Percentage of Hypoglycemic Values \< 50 mg/dL. The comparison was conducted at the α=0.05 (2-sided) significance level.||0.0|-0.1|0.332
70886531|NCT00025883|141259307|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||A null hypothesis of interest is there is no significant change over three time points (baseline, 6 months, 12 months) in response to metreleptin within GLD group.||||<0.001
70886532|NCT00025883|141259307|SUPERIORITY_OR_OTHER|||||||0.004|||||||Mixed Models Analysis|||A null hypothesis of interest is there is no significant change over three time points (baseline, 6 months, 12 months) in response to metreleptin within PLD group.||||0.004
70886533|NCT00025883|141259308|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||Triglycerides were log transformed for analysis due to non-normal distribution. Changes in triglycedies in response to metreleptin over three time points (baseline, 6 months, 12 months) are tested within GLD group.||||0.05
70886534|NCT00025883|141259308|SUPERIORITY_OR_OTHER|||||||0.02|||||||Mixed Models Analysis|||Triglycerides were log transformed for analysis due to non-normal distribution. Changes in triglycedies in response to metreleptin over three time points (baseline, 6 months, 12 months) are tested within PLD group.||||0.02
70886535|NCT05569954|141259349|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|-1.6|||||TWO_SIDED|95.0|-4.0|0.7|||||V116 minus PPSV23|Injection site erythema: estimated difference in percent||0.7|-4.0|
70886536|NCT05569954|141259349|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|3.7|||||TWO_SIDED|95.0|-1.2|8.7|||||V116 minus PPSV23|Injection site pain: estimated difference in percent||8.7|-1.2|
70886537|NCT05569954|141259349|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|0.6|||||TWO_SIDED|95.0|-1.6|2.7|||||V116 minus PPSV23|Injection site swelling: estimated difference in percent||2.7|-1.6|
70886538|NCT05569954|141259350|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|0.9|||||TWO_SIDED|95.0|-2.9|4.6|||||V116 minus PPSV23|Fatigue: estimated difference in percent||4.6|-2.9|
70886539|NCT05569954|141259350|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|1.7||||||95.0|-1.8|5.1|||||V116 minus PPSV23|Headache: estimated difference in percent||5.1|-1.8|
70886540|NCT05569954|141259350|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|-0.7||||||95.0|-3.1|1.7|||||V116 minus PPSV23|Myalgia: estimated difference in percent||1.7|-3.1|
70886541|NCT05569954|141259350|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|-0.3||||||95.0|-1.5|0.9|||||V116 minus PPSV23|Pyrexia: estimated difference in percent||0.9|-1.5|
70886542|NCT05569954|141259351|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|0.0||||||95.0|-0.5|0.5|||||V116 minus PPSV23|Vaccine-Related Serious Adverse Events||0.5|-0.5|
70886543|NCT05569954|141259352|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.96|1.23||1-sided|cLDA model||V116/PPSV23|Serotype 3: V116/PPSV23 GMT Ratio||1.23|0.96|<0.001
70886544|NCT05569954|141259352|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.47|||<|0.001|TWO_SIDED|95.0|1.29|1.68||1-sided|cLDA model||V116/PPSV23|Serotype 7F: V116/PPSV23 GMT Ratio||1.68|1.29|<0.001
70886545|NCT05569954|141259352|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.17|||<|0.001|TWO_SIDED|95.0|1.04|1.32||1-sided|cLDA model||V116/PPSV23|Serotype 8: V116/PPSV23 GMT Ratio||1.32|1.04|<0.001
70886546|NCT05569954|141259352|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.12|||<|0.001||95.0|1.0|1.26||1-sided|cLDA model||V116/PPSV23|Serotype 9N: V116/PPSV23 GMT Ratio||1.26|1.00|<0.001
70886547|NCT05569954|141259352|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.55|||<|0.001|TWO_SIDED|95.0|1.37|1.77|||cLDA model||V116/PPSV23|Serotype 10A: V116/PPSV23 GMT Ratio||1.77|1.37|<0.001
70886548|NCT05569954|141259352|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|2.05|||<|0.001||95.0|1.82|2.31|||cLDA model||V116/PPSV23|Serotype 11A: V116/PPSV23 GMT Ratio||2.31|1.82|<0.001
70886549|NCT05569954|141259352|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.63|||<|0.001|TWO_SIDED|95.0|1.4|1.9|||cLDA model||V116/PPSV23|Serotype 12F: V116/PPSV23 GMT Ratio||1.90|1.40|<0.001
70886550|NCT05569954|141259352|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|2.02|||<|0.001|TWO_SIDED|95.0|1.77|2.31|||cLDA model||V116/PPSV23|Serotype 17F: V116/PPSV23GMT Ratio||2.31|1.77|<0.001
70886551|NCT05569954|141259352|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.42|||<|0.001|TWO_SIDED|95.0|1.26|1.6|||cLDA model||V116/PPSV23|Serotype 19A: V116/PPSV23 GMT Ratio||1.60|1.26|<0.001
70886552|NCT05569954|141259352|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.66|||<|0.001|TWO_SIDED|95.0|1.46|1.88|||cLDA model||V116/PPSV23|Serotype 20A: V116/PPSV23 GMT Ratio||1.88|1.46|<0.001
70886553|NCT05569954|141259352|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.53|||<|0.001|TWO_SIDED|95.0|1.34|1.75|||cLDA model||V116/PPSV23|Serotype 22F: V116/PPSV23 GMT Ratio||1.75|1.34|<0.001
70886554|NCT05569954|141259352|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|0.89|||<|0.001|TWO_SIDED|95.0|0.76|1.04|||cLDA model||V116/PPSV23|Serotype 33F: V116/PPSV23 GMT Ratio||1.04|0.76|<0.001
70886555|NCT05569954|141259352|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|3.31|||<|0.001|TWO_SIDED|95.0|2.84|3.87||1-sided|cLDA model||V116/PPSV23|Serotype 6A: V116/PPSV23 GMT Ratio||3.87|2.84|<0.001
70886556|NCT05569954|141259352|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|4.61|||<|0.001|TWO_SIDED|95.0|3.99|5.33||1-sided|cLDA model||V116/PPSV23|Serotype 15A: V116/PPSV23 GMT Ratio||5.33|3.99|<0.001
70886557|NCT05569954|141259352|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|2.92|||<|0.001||95.0|2.5|3.42||1-sided|cLDA model||V116/PPSV23|Serotype 15C: V116/PPSV23 GMT Ratio||3.42|2.50|<0.001
70886558|NCT05569954|141259352|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|4.5|||<|0.001|TWO_SIDED|95.0|3.99|5.09||1-sided|cLDA model||V116/PPSV23|Serotype 16F: V116/PPSV23 GMT Ratio||5.09|3.99|<0.001
70886559|NCT05569954|141259352|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|5.74|||<|0.001|TWO_SIDED|95.0|4.81|6.85||1-sided|cLDA model||V116/PPSV23|Serotype 23A: V116/PPSV23 GMT Ratio||6.85|4.81|<0.001
70886560|NCT05569954|141259352|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|16.42|||<|0.001|TWO_SIDED|95.0|13.46|20.03||1-sided|cLDA model||V116/PPSV23|Serotype 23B: V116/PPSV23 GMT Ratio||20.03|13.46|<0.001
70886561|NCT05569954|141259352|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|3.39|||<|0.001||95.0|2.97|3.87||1-sided|cLDA model||V116/PPSV23|Serotype 24F: V116/PPSV23 GMT Ratio||3.87|2.97|<0.001
70886562|NCT05569954|141259352|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|11.89|||<|0.001|TWO_SIDED|95.0|10.16|13.91||1-sided|cLDA model||V116/PPSV23|Serotype 31: V116/PPSV23 GMT Ratio||13.91|10.16|<0.001
70886563|NCT05569954|141259352|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|6.17|||<|0.001|TWO_SIDED|95.0|5.54|6.87||1-sided|cLDA model||V116/PPSV23|Serotype 35B: V116/PPSV23 GMT Ratio||6.87|5.54|<0.001
70886564|NCT05569954|141259353|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|26.0|||<|0.001|TWO_SIDED|95.0|20.9|31.0||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 6A: V116-PPSV23 Percentage Difference||31.0|20.9|<0.001
70886565|NCT05569954|141259353|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|39.4|||<|0.001|TWO_SIDED|95.0|33.6|44.8||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 15A: V116-PPSV23 Percentage Difference||44.8|33.6|<0.001
70886566|NCT05569954|141259353|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|11.7||||0.214|TWO_SIDED|95.0|7.5|15.9||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 15C: V116-PPSV23 Percentage Difference||15.9|7.5|0.214
70886567|NCT05569954|141259353|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|42.9|||<|0.001|TWO_SIDED|95.0|37.8|47.8||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 16F: V116-PPSV23 Percentage Difference||47.8|37.8|<0.001
70886568|NCT05569954|141259353|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|35.9|||<|0.001||95.0|29.6|41.8||1-sided|Stratified Miettinen & Nurminen method||V16 minus PPSV23|Serotype 23A: V116-PPSV23 Percentage Difference||41.8|29.6|<0.001
70886569|NCT05569954|141259353|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|42.4|||<|0.001|TWO_SIDED|95.0|37.6|47.0||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 23B: V116-PPSV23 Percentage Difference||47.0|37.6|<0.001
70886570|NCT05569954|141259353|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|35.9|||<|0.001||95.0|30.6|41.0||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 24F: V116-PPSV23 Percentage Difference||41.0|30.6|<0.001
70886571|NCT05569954|141259353|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|56.2|||<|0.001|TWO_SIDED|95.0|51.5|60.5||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 31: V116-PPSV23 Percentage Difference||60.5|51.5|<0.001
70886572|NCT05569954|141259353|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|58.7|||<|0.001||95.0|54.6|62.7||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 35B: V116-PPSV23 Percentage Difference||62.7|54.6|<0.001
70886573|NCT05569954|141259354|OTHER|"A conclusion of acceptability is based on the lower bound of the 95% CI of the percentages of participants with a~≥4 fold rise from baseline to 30 days postvaccination being \>50 percentage points (1-sided p-value \<0.025)."||||||0.093||||||1-sided|Clopper-Pearson method|||Serotype 6C||||0.093
70886574|NCT05569954|141259354|OTHER|"A conclusion of acceptability is based on the lower bound of the 95% CI of the percentages of participants with a~≥4 fold rise from baseline to 30 days postvaccination being \>50 percentage points (1-sided p-value \<0.025)."|||||<|0.001||||||1-sided|Clopper-Pearson method|||Serotype 15B||||<0.001
70886575|NCT05569954|141259356|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.14|||||TWO_SIDED|95.0|1.04|1.25|||||V116/PPSV23|Serotype 3: V116/PPSV23 GMC Ratio||1.25|1.04|
70886576|NCT05569954|141259356|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.86|||||TWO_SIDED|95.0|1.65|2.1|||||V116/PPSV23|Serotype 7F: V116/PPSV23 GMC Ratio||2.10|1.65|
70886577|NCT05569954|141259356|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.17|||||TWO_SIDED|95.0|1.04|1.31|||||V116/PPSV23|Serotype 8: V116/PPSV23 GMC Ratio||1.31|1.04|
70886578|NCT05569954|141259356|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.55|||||TWO_SIDED|95.0|1.37|1.76|||||V116/PPSV23|Serotype 9N: V116/PPSV23 GMC Ratio||1.76|1.37|
70886579|NCT05569954|141259356|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|2.03|||||TWO_SIDED|95.0|1.79|2.31|||||V116/PPSV23|Serotype 10A: V116/PPSV23 GMC Ratio||2.31|1.79|
70886580|NCT05569954|141259356|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|2.2|||||TWO_SIDED|95.0|1.97|2.46|||||V116/PPSV23|Serotype 11A: V116/PPSV23 GMC Ratio||2.46|1.97|
70886581|NCT05569954|141259356|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.99|||||TWO_SIDED|95.0|1.72|2.3|||||V116/PPSV23|Serotype 12F: V116/PPSV23 GMC Ratio||2.30|1.72|
70886582|NCT05569954|141259356|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|2.39|||||TWO_SIDED|95.0|2.12|2.7|||||V116/PPSV23|Serotype 17F: V116/PPSV23 GMC Ratio||2.70|2.12|
70886583|NCT05569954|141259356|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.49|||||TWO_SIDED|95.0|1.32|1.67||||||Serotype 19A: V116/PPSV23 GMC Ratio|V116/PPSV23|1.67|1.32|
70886584|NCT05569954|141259356|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.86|||||TWO_SIDED|95.0|1.65|2.1|||||V116/PPSV23|Serotype 20A: V116/PPSV23 GMC Ratio||2.10|1.65|
70886585|NCT05569954|141259356|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.77|||||TWO_SIDED|95.0|1.55|2.02|||||V116/PPSV23|Serotype 22F: V116/PPSV23 GMC Ratio||2.02|1.55|
70886586|NCT05569954|141259356|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.22|||||TWO_SIDED|95.0|1.08|1.37|||||V116/PPSV23|Serotype 33F: V116/PPSV23 GMC Ratio||1.37|1.08|
70886587|NCT05569954|141259356|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|3.78|||||TWO_SIDED|95.0|3.29|4.35|||||V116/PPSV23|Serotype 6A: V116/PPSV23 GMC Ratio||4.35|3.29|
70886588|NCT05569954|141259356|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|8.92|||||TWO_SIDED|95.0|7.89|10.09|||||V116/PPSV23|Serotype 15A: V116/PPSV23 GMC Ratio||10.09|7.89|
70886589|NCT05569954|141259356|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|3.43|||||TWO_SIDED|95.0|3.01|3.92|||||V116/PPSV23|Serotype 15C: V116/PPSV23 GMC Ratio||3.92|3.01|
70886590|NCT05569954|141259356|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|9.84|||||TWO_SIDED|95.0|8.83|10.97|||||V116/PPSV23|Serotype 16F: V116/PPSV23 GMC Ratio||10.97|8.83|
70886591|NCT05569954|141259356|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|7.59|||||TWO_SIDED|95.0|6.68|8.61|||||V116/PPSV23|Serotype 23A: V116/PPSV23 GMC Ratio||8.61|6.68|
70886592|NCT05569954|141259356|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|4.79|||||TWO_SIDED|95.0|4.26|5.38|||||V116/PPSV23|Serotype 23B: V116/PPSV23 GMC Ratio||5.38|4.26|
70886593|NCT05569954|141259356|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|21.19||||||95.0|18.98|23.65|||||V116/PPSV23|Serotype 24F: V116/PPSV23 GMC Ratio||23.65|18.98|
70886594|NCT05569954|141259356|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|8.69|||||TWO_SIDED|95.0|7.82|9.65|||||V116/PPSV23|Serotype 31: V116/PPSV23 GMC Ratio||9.65|7.82|
70886595|NCT05569954|141259356|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|15.53|||||TWO_SIDED|95.0|14.13|17.07|||||V116/PPSV23|Serotype 35B: V116/PPSV23 GMC Ratio||17.07|14.13|
70886596|NCT01660412|141259360|OTHER||Mean Difference (Final Values)|1.42|STANDARD_DEVIATION|2.17|<|0.0001|TWO_SIDED|95.0|0.85|2.0|||t-test, 2 sided|||||2.00|0.85|<0.0001
70886597|NCT04524403|141259398|SUPERIORITY||Least Squares Mean Difference|0.24||||0.787|TWO_SIDED|95.0|-1.52|2.01|||Mixed Models Analysis|||||2.01|-1.52|0.7870
70886598|NCT04524403|141259398|SUPERIORITY||Least Squares Mean Difference|0.75||||0.4018|TWO_SIDED|95.0|-1.01|2.51|||Mixed Models Analysis|||||2.51|-1.01|0.4018
70886599|NCT04524403|141259399|SUPERIORITY||Least Squares Mean Difference|0.5||||0.5228|TWO_SIDED|95.0|-1.03|2.02|||Mixed Models Analysis|||||2.02|-1.03|0.5228
70886600|NCT04524403|141259400|SUPERIORITY||Odds Ratio (OR)|1.781||||0.2537|TWO_SIDED|95.0|0.661|4.802|||Regression, Logistic|||||4.802|0.661|0.2537
70886601|NCT04524403|141259400|SUPERIORITY||Odds Ratio (OR)|0.916||||0.874|TWO_SIDED|95.0|0.308|2.722|||Regression, Logistic|||||2.722|0.308|0.8740
70886602|NCT04524403|141259401|SUPERIORITY||Least Squares Mean Difference|0.0||||0.987|TWO_SIDED|95.0|-0.021|0.021|||Mixed Models Analysis|||||0.021|-0.021|0.9870
70886603|NCT04524403|141259401|SUPERIORITY||Least Squares Mean Difference|0.008||||0.4624|TWO_SIDED|95.0|-0.013|0.029|||Mixed Models Analysis|||||0.029|-0.013|0.4624
70886604|NCT02449356|141259405|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73|||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
70886605|NCT02449356|141259406|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
70886606|NCT00533949|141259411|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.38||||0.0042|TWO_SIDED|95.0|1.09|1.76|||Log Rank||Reference group = 60 gy|The trial was a two-by-two factorial design with radiation therapy dose as one treatment factor and cetuximab as the other. A log-rank test for each factor at one-sided α of 0.0125 (α of 0.0250 for both factors to account for multiple comparisons) would yield power of 80% to detect an improvement in median survival from 17.1 to 24 months after 339 deaths were reported out of 500 patients. For RT analysis, the comparison was arms 1 \& 3 vs arms 2 \& 4; for cetuximab, arms 1 \& 2 vs arms 3 \& 4.||1.76|1.09|0.0042
70886607|NCT00533949|141259411|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.07||||0.29|TWO_SIDED|95.0|0.84|1.35|||Log Rank||Reference level = cetuximab|The trial was a two-by-two factorial design with radiation therapy dose as one treatment factor and cetuximab as the other. A log-rank test for each factor at one-sided α of 0.0125 (α of 0.0250 for both factors to account for multiple comparisons) would yield power of 80% to detect an improvement in median survival from 17.1 to 24 months after 339 deaths were reported out of 500 patients. For RT analysis, the comparison was arms 1 \& 3 vs arms 2 \& 4; for cetuximab, arms 1 \& 2 vs arms 3 \& 4.||1.35|0.84|0.29
70886608|NCT00533949|141259412|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.19||||0.12|TWO_SIDED|95.0|0.95|1.47|||Log Rank||Reference level = 60 Gy|Progression-free survival is estimated by the Kaplan-Meier method. Comparisons by RT level and by cetuximab assignment are performed separately and tested with a two-sided significance level of 0.05 for each comparison.||1.47|0.95|0.12
70886609|NCT00533949|141259412|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99||||0.89|TWO_SIDED|95.0|0.8|1.22|||Log Rank||Reference level = cetuximab|Progression-free survival is estimated by the Kaplan-Meier method. Comparisons by RT level and by cetuximab assignment are performed separately and tested with a two-sided significance level of 0.05.||1.22|0.80|0.89
70886610|NCT00533949|141259413|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17||||0.24|TWO_SIDED|95.0|0.89|1.53|||Gray's test||Reference level = 60 Gy|Local-regional failure was estimated by the cumulative incidence method. Comparisons by RT level and by cetuximab assignment are performed separately and tested with a two-sided significance level of 0.05 for each comparison.||1.53|0.89|0.24
70886611|NCT00533949|141259413|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.22|TWO_SIDED|95.0|0.64|1.1|||Gray's test||Reference level = cetuximab|Local-regional failure was estimated by the cumulative incidence method. Comparisons by RT level and by cetuximab assignment are performed separately and tested with a two-sided significance level of 0.05 for each comparison.||1.10|0.64|0.22
70886612|NCT00533949|141259414|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Chi-squared|||Esophagitis: Only those toxicities reported as possibly, probably, or definitely related to treatment were considered. The worst grade of esophagitis and the worst grade of pneumonitis at any time were classified by binary groupings of \< grade 3 and \>= grade 3. Comparisons were made using a two-sided chi-square test with a significance level of 0.05.||||<0.0001
70886613|NCT00533949|141259414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2533|||||||Chi-squared|||PNEUMONITIS: Only those toxicities reported as possibly, probably, or definitely related to treatment were considered. The worst grade of esophagitis and the worst grade of pneumonitis at any time were classified by binary groupings of \< grade 3 and \>= grade 3. Comparisons were made using a two-sided chi-square test with a significance level of 0.05.||||0.2533
70886614|NCT00533949|141259415|SUPERIORITY_OR_OTHER_LEGACY|||||||0.52|||||||Chi-squared|||Only those toxicities reported as possibly, probably, or definitely related to treatment were considered. The worst grade of of toxicity at any time was classified by a binary grouping of \< grade 3 and \>= grade 3. Comparisons were made using a two-sided chi-square test.||||0.52
70886615|NCT00533949|141259417|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0233|||||||Cochran-Mantel-Haenszel|||FACT-TOI-LCS was assessed and changes from baseline to 3 months calculated and grouped using a 2 point decline as the threshold. Comparisons of decline vs no decline by RT level were from a Cochran-Mantel-Haenszel test and controlling for cetuximab assignment using a two-side significance level of 0.05.||||0.0233
70886616|NCT00533949|141259418|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|Two-sided significance level = 0.05||||||0.92
70886617|NCT00533949|141259419|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|Two-sided significance level = 0.05||||||0.19
70886618|NCT00533949|141259420|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.78|TWO_SIDED|95.0|0.68|1.33|||Regression, Cox||Reference level = EGFR H-Score \< 200|Univariate model of overall survival by EGFR group||1.33|0.68|0.78
70886619|NCT00533949|141259420|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.61|TWO_SIDED|95.0|0.74|1.65|||Regression, Cox||Reference level = EGFR H-Score \< 200|Univariate model of time to local-regional failure by EGFR group||1.65|0.74|0.61
70886620|NCT00533949|141259421|SUPERIORITY|||||||0.02||||||Two-sided significance level = 0.05|Chi-squared|||||||0.02
70886621|NCT00533949|141259422|OTHER||Cox Proportional Hazard|1.001||||0.06|TWO_SIDED|95.0|1.0|1.002||Two-sided significance level = 0.05|Regression, Cox||Corresponding to a one unit increase in GTV|Univariate model with GTV as a continuous variable||1.002|1.000|0.06
70886622|NCT00533949|141259422|SUPERIORITY||Hazard Ratio (HR)|1.001||||0.78|TWO_SIDED|95.0|0.997|1.004||Two-sided significance level = 0.05|Regression, Cox||Corresponding to a one unit increase in GTV|Multivariate model with GTV as a continuous variable, adjusting for planned radiation therapy dose group (60 Gy or 74 Gy) and the interaction of GTV and planned dose.|P-Value for the interaction of GTV and planned dose = 0.77|1.004|0.997|0.78
70886623|NCT00533949|141259423|SUPERIORITY||Cox Proportional Hazard|1.0||||0.94|TWO_SIDED|95.0|0.98|1.02|||Regression, Cox||Corresponding to a one unit increase in SUV|Univariate model of overall survival time by PET SUV as a continuous variable||1.02|0.98|0.94
70886624|NCT00533949|141259423|SUPERIORITY||Cox Proportional Hazard|1.0||||0.72|TWO_SIDED|95.0|0.98|1.02|||Regression, Cox||Corresponding to a one unit increase in SUV|Univariate model of time to local-regional failure by PET SUV as a continuous variable||1.02|0.98|0.72
70886625|NCT00533949|141259423|SUPERIORITY||Cox Proportional Hazard|1.0||||0.79|TWO_SIDED|95.0|0.98|1.02|||Regression, Cox||Corresponding to a one unit increase in SUV|Univariate model of time to distant metastasis by PET SUV as a continuous variable||1.02|0.98|0.79
70886626|NCT00727194|141259425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.25||||0.0144|TWO_SIDED|95.0|-7.45|-1.05||No multiple comparisons or multiplicity adjustments were conducted.|paired t-test|||||-1.05|-7.45|0.0144
70886627|NCT00727194|141259425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.71||||0.117|TWO_SIDED|95.0|-10.8|1.37||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||||1.37|-10.80|0.1170
70886628|NCT00727194|141259426|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED|||||No multiple comparisons or multiplicity adjustments were conducted.|Chi-squared|||||||1.0000
70886629|NCT00727194|141259426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0606|TWO_SIDED|||||No multiple comparisons or multiplicity adjustments were conducted.|Chi-squared|||||||0.0606
70886630|NCT00727194|141259427|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.58||||0.1873|TWO_SIDED|95.0|-4.08|0.91||No multiple comparisons or multiplicity adjustments were conducted.|paired t-test|||||0.91|-4.08|0.1873
70886631|NCT00727194|141259427|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-3.57||||0.041|TWO_SIDED|95.0|-6.97|-0.17||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||||-0.17|-6.97|0.0410
70886632|NCT00727194|141259428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.83||||0.919|TWO_SIDED|95.0|-16.94|18.6||No multiple comparisons or multiplicity adjustments were conducted.|paired t-test|||Physical Functioning||18.60|-16.94|0.9190
70886633|NCT00727194|141259428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.86||||0.5931|TWO_SIDED|95.0|-39.05|23.33||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Physical Functioning||23.33|-39.05|0.5931
70886634|NCT00727194|141259428|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|3.13||||0.7319|TWO_SIDED|95.0|-16.64|22.89||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Role Physical||22.89|-16.64|0.7319
70886635|NCT00727194|141259428|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|-7.14||||0.691|TWO_SIDED|95.0|-45.36|31.08||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Role Physical||31.08|-45.36|0.6910
70886636|NCT00727194|141259428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-9.42||||0.1311|TWO_SIDED|95.0|-22.18|3.34||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Bodily Pain||3.34|-22.18|0.1311
70886637|NCT00727194|141259428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-14.86||||0.2406|TWO_SIDED|95.0|-41.08|11.36||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Bodily Pain||11.36|-41.08|0.2406
70886638|NCT00727194|141259428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.17||||0.0578|TWO_SIDED|95.0|-0.29|14.62||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||General Health||14.62|-0.29|0.0578
70886639|NCT00727194|141259428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.43||||0.5073|TWO_SIDED|95.0|-16.26|31.11||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||General Health||31.11|-16.26|0.5073
70886640|NCT00727194|141259428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.17||||0.2474|TWO_SIDED|95.0|-3.39|11.72||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Vitality||11.72|-3.39|0.2474
70886641|NCT00727194|141259428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.68||||0.8085|TWO_SIDED|95.0|-26.24|20.88||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Vitality||20.88|-26.24|0.8085
70886642|NCT00727194|141259428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-11.46||||0.0716|TWO_SIDED|95.0|-24.13|1.21||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Social Functioning||1.21|-24.13|0.0716
70886643|NCT00727194|141259428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-16.07||||0.1966|TWO_SIDED|95.0|-41.68|9.54||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Social Functioning||9.54|-41.68|0.1966
70886644|NCT00727194|141259428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-11.81||||0.1701|TWO_SIDED|95.0|-29.6|5.99||No multiple comparisons or multiplicity adjustments were conducted.|paired t-test|||Role Emotional||5.99|-29.60|0.1701
70886645|NCT00727194|141259428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.95||||0.7422|TWO_SIDED|95.0|-32.58|44.48||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Role Emotional||44.48|-32.58|0.7422
70886646|NCT00727194|141259428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.42||||0.9007|TWO_SIDED|95.0|-6.83|7.67||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Mental Health||7.67|-6.83|0.9007
70886647|NCT00727194|141259428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|17.86||||0.1519|TWO_SIDED|95.0|-7.57|43.29||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Mental Health||43.29|-7.57|0.1519
70886648|NCT00727194|141259428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.07||||0.6807|TWO_SIDED|95.0|-4.57|6.72||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Physical Component Score||6.72|-4.57|0.6807
70886649|NCT00727194|141259428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.23||||0.2226|TWO_SIDED|95.0|-16.79|4.32||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Physical Component Score||4.32|-16.79|0.2226
70886650|NCT00727194|141259428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.92||||0.1505|TWO_SIDED|95.0|-7.1|1.26||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Mental Component Score||1.26|-7.10|0.1505
70886651|NCT00727194|141259428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.55||||0.4151|TWO_SIDED|95.0|-8.77|19.87||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Mental Component Score||19.87|-8.77|0.4151
70886652|NCT00727194|141259429|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.25||||0.3377|TWO_SIDED|95.0|-3.94|10.44||No multiple comparisons or multiplicity adjustments were conducted.|paired t-test|||Forced Vital Capacity||10.44|-3.94|0.3377
70886653|NCT00727194|141259429|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|-10.57||||0.3391|TWO_SIDED|95.0|-33.71|12.56||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Forced Vital Capacity||12.56|-33.71|0.3391
70886654|NCT00727194|141259429|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||1|TWO_SIDED|95.0|-4.35|4.35||No multiple comparisons or multiplicity adjustments were conducted.|paired t test|||Negative Inspiratory Force||4.35|-4.35|1.0000
70886655|NCT00727194|141259429|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-6.57||||0.2292|TWO_SIDED|95.0|-17.87|4.73||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Negative Inspiratory Force||4.73|-17.87|0.2292
70886656|NCT04269161|141259442|NON_INFERIORITY|The margin of non-inferiority is 10 seconds such that the device is no worse than 10 seconds on average than manual mode. Our study is a 2-treatment, 24-period crossover design that accounts for first-order carryover effects, indicating a slightly higher power than a 2x2. Each subject acted as their own control. The study was defined as intention to treat, such that manual adjustments during the automated arm would be included in that arm.|Mean Difference (Net)|-9.885||||0.003|TWO_SIDED|95.0|-16.51|-3.27||The p-value is significant at 0.01.|t-test, 2 sided||The difference is time to re-establish in automatic mode minus time to re-establish in manual mode. (a negative number favors automatic mode)|A sample requirement of 48 patients was determined based on a pilot study to provide 88% power, and 0.05 significance (two sided) to show the mean difference is less than 10 seconds based on a 2x2 crossover design. Considering patient drop-out, a sample size of n=40 drops power to 82%.||-3.27|-16.51|0.003
70886657|NCT04269161|141259443|OTHER|The difference is defined as the difference of proportion of time in the target range of SpO2 in modes, automatic minus manual. Our study is a 2-treatment, 24-period crossover design that accounts for first-order carryover effects, indicating a slightly higher power than a 2x2. Each subject acted as their own control. The study was defined as intention to treat, such that manual adjustments during the automated arm would be included in that arm.|Mean Difference (Net)|0.018||||0.02|TWO_SIDED|95.0|0.003|0.034||The threshold for statistical significance is p=.05|t-test, 2 sided|Two-sample t test with equal variances. Linear mixed model patient random effects, adjusted for site, sex, race, weight, gestational age, bed type.|Treatment difference = automatic - manual. A positive number favors automatic.|The difference in the proportion of time in the target saturation is calculated between the automatic and manual models. For each 6-hour time block, we calculate the proportion of time the patient stays within the prescribed SpO2 range.||.034|0.003|.02
70886658|NCT01513317|141259444|SUPERIORITY_OR_OTHER||Difference in proportions|0.082||||0.271|TWO_SIDED|95.0|-0.03|0.2|||Cochran-Mantel-Haenszel||The estimated parameter is the difference in proportion of participants who had a reduction in RBC transfusion to treat the anemia of MDS.|||0.20|-0.03|0.271
70886659|NCT01513317|141259445|SUPERIORITY_OR_OTHER||Difference in LS means|0.07||||0.872|TWO_SIDED|95.0|-0.79|0.93|||ANCOVA||The estimated parameter is the difference in LS means of the change from baseline hemoglobin levels at Week 13.|||0.93|-0.79|0.872
70886660|NCT01513317|141259446|SUPERIORITY_OR_OTHER||Difference in proportions|0.042||||0.494|TWO_SIDED|95.0|-0.06|0.15|||Cochran-Mantel-Haenszel||The estimated parameter is the difference in proportion of participants achieving hemoglobin improvement at Week 13.|||0.15|-0.06|0.494
70886661|NCT01513317|141259447|SUPERIORITY_OR_OTHER||Difference in proportions|0.002||||0.986|TWO_SIDED|95.0|-0.09|0.09|||Cochran-Mantel-Haenszel||The estimated parameter is the difference in proportion of participants who did not require a blood transfusion in the 8 weeks of treatment before unblinding at Week 13.|||0.09|-0.09|0.986
70886662|NCT01513317|141259448|SUPERIORITY_OR_OTHER||Difference in LS means|1.96||||0.363|TWO_SIDED|95.0|-2.35|6.27|||ANCOVA||The estimated parameter is the difference in LS means for changes from baseline in bone marrow blasts at Week 13.|||6.27|-2.35|0.363
70886663|NCT01513317|141259449|SUPERIORITY_OR_OTHER||Difference in LS means|-1.69||||0.073|TWO_SIDED|95.0|-3.55|0.17|||ANCOVA||The estimated parameter is the difference in LS means of the number of RBC transfusions during the 8 weeks of treament before unblinding at Week 13.|||0.17|-3.55|0.073
70886664|NCT03354429|141259486|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.015|TWO_SIDED|95.0|0.71|0.96||The hypothesis was tested at the 4.996% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence was used to address the issue of multiple testing|Regression, Cox||Placebo is the reference group (denominator)|||0.96|0.71|0.015
70886665|NCT03354429|141259487|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.004|TWO_SIDED|95.0|0.68|0.93||The hypothesis was tested at the 4.996% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence was used to address the issue of multiple testing|Regression, Cox||Placebo is the reference group (denominator)|||0.93|0.68|0.004
70886666|NCT03354429|141259488|SUPERIORITY||Odds Ratio (OR)|0.98||||0.613|TWO_SIDED|95.0|0.89|1.07||The hypothesis was tested at the 4.996% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence was used to address the issue of multiple testing|Regression, Logistic|NIHSS (National Institutes of Health Stroke Scale) score and history of stroke (yes/no) included as covariates|Placebo is the reference group (denominator)|||1.07|0.89|0.613
70886667|NCT03354429|141259489|OTHER||Hazard Ratio (HR)|3.99||||0.001|TWO_SIDED|95.0|1.74|9.14|||Regression, Cox||Placebo is the reference group (denominator)|||9.14|1.74|0.001
70886668|NCT03354429|141259490|OTHER||Hazard Ratio (HR)|3.66||||0.005|TWO_SIDED|95.0|1.48|9.02|||Regression, Cox||Placebo is the reference group (denominator)|||9.02|1.48|0.005
70886669|NCT03354429|141259491|OTHER||Hazard Ratio (HR)|3.27|||<|0.001|TWO_SIDED|95.0|1.67|6.43|||Regression, Cox||Placebo is the reference group (denominator)|||6.43|1.67|<0.001
70886670|NCT03354429|141259492|OTHER||Hazard Ratio (HR)|4.8|||<|0.001|TWO_SIDED|95.0|3.28|7.02|||Regression, Cox||Placebo is the reference group (denominator)|||7.02|3.28|<0.001
70886671|NCT02566759|141259542|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.6662|||||TWO_SIDED|90.0|0.5969|0.7355||||||Dose proportionality was evaluated using the following power model: ln (PK Parameter) is equal to (=) a+b\*ln (dose), where a and b are the intercept and slope of the line, respectively. Dose proportionality was declared when the 90 percent (%) confidence interval (CI) of the slope lies entirely within the critical region (0.9483, 1.0517) for the dose range of 10 mg to 750 mg.||0.7355|0.5969|
70886672|NCT02566759|141259542|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.7795|||||TWO_SIDED|90.0|0.6597|0.8993|||Power model|||Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b\*ln (dose), where a and b were the intercept and slope of the line, respectively. Dose proportionality was declared when the 90% CI of the slope lies entirely within the critical region (0.9139, 1.0861) for the dose range of 30 mg to 400 mg.||0.8993|0.6597|
70886673|NCT02566759|141259542|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) Mean Ratio|0.362|||||TWO_SIDED|90.0|0.3043|0.4301||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed lease square (LS) Means.||0.4301|0.3043|
70886674|NCT02566759|141259542|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Ratio|1.799|||||TWO_SIDED|90.0|1.4625|2.2116||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.||2.2116|1.4625|
70886675|NCT02566759|141259545|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.872|||||TWO_SIDED|90.0|0.8145|0.9296||||||Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b\*ln (dose), where a and b are the intercept and slope of the line, respectively. Dose proportionality was declared when the 90 % CI of the slope lies entirely within the critical region (0.9483, 1.0517) for the dose range of 10 mg to 750 mg.||0.9296|0.8145|
70886676|NCT02566759|141259545|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.9135|||||TWO_SIDED|90.0|0.8062|1.0209|||Power model|||Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b\*ln (dose), where a and b were the intercept and slope of the line, respectively. Dose proportionality was declared when the 90% CI of the slope lies entirely within the critical region (0.9139, 1.0861) for the dose range of 30 mg to 400 mg.||1.0209|0.8062|
70886677|NCT02566759|141259545|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Ratio|0.5|||||TWO_SIDED|90.0|0.4324|0.5777||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.||0.5777|0.4324|
70886678|NCT02566759|141259545|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Ratio|2.563|||||TWO_SIDED|90.0|2.1|3.1275||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.||3.1275|2.1000|
70886679|NCT02566759|141259546|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.8505|||<|0.001|TWO_SIDED|90.0|0.7925|0.9084|||Power model|||Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b\*ln (dose), where a and b are the intercept and slope of the line, respectively. Dose proportionality was declared when the 90 % CI of the slope lies entirely within the critical region (0.9483, 1.0517) for the dose range of 10 mg to 750 mg.||0.9084|0.7925|<0.001
70886680|NCT02566759|141259546|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.8415|||<|0.001|TWO_SIDED|90.0|0.7618|0.9212|||Power model|||Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b\*ln (dose), where a and b were the intercept and slope of the line, respectively. Dose proportionality was declared when the 90% CI of the slope lies entirely within the critical region (0.9139, 1.0861) for the dose range of 30 mg to 400 mg.||0.9212|0.7618|<0.001
70886681|NCT02566759|141259546|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Ratio|0.543|||||TWO_SIDED|90.0|0.4797|0.6149||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.||0.6149|0.4797|
70886682|NCT02566759|141259546|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Ratio|2.336|||||TWO_SIDED|90.0|1.9592|2.7854||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.||2.7854|1.9592|
70886683|NCT01513291|141259555|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.4||||0.33153|TWO_SIDED|95.0|-1.3|0.4|||Constrained Longitudinal Analysis (cLDA)||Risk difference is for MK-6096 - Placebo. The cLDA model included terms for treatment, time, treatment-by-time interaction, monthly migraine days during the Screening (Baseline) Period (≤8, \>8) as covariates|||0.4|-1.3|0.33153
70886684|NCT01513291|141259556|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.3|||||TWO_SIDED|95.0|-3.4|21.6|||||Risk difference (MK-6096 - Placebo) was estimated based on the Miettinen \& Nurminen method|||21.6|-3.4|
70886685|NCT01513291|141259557|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.3|||||TWO_SIDED|95.0|-4.0|8.9|||||Risk difference (MK-6096 - Placebo) was estimated based on the Miettinen \& Nurminen method|||8.9|-4.0|
70886686|NCT01513291|141259558|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.5||||0.24008|TWO_SIDED|95.0|-1.4|0.4|||Constrained Longitudinal Analysis (cLDA)||Risk difference is for MK-6096 - Placebo. The cLDA model included terms for treatment, time, treatment-by-time interaction, monthly migraine days during the Screening (Baseline) Period (≤8, \>8) as covariates|||0.4|-1.4|0.24008
70886687|NCT01513291|141259559|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.43093|TWO_SIDED|95.0|0.7|2.0|||Generalized linear mixed effects model||Odds ratio is for MK-6096 / Placebo. The generalized linear mixed effects model included terms for treatment, time, treatment-by-time interaction, monthly migraine days during the Screening (Baseline) Period 1 (≤8, \>8) as covariates.|||2.0|0.7|0.43093
70886688|NCT01513291|141259560|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.9737|TWO_SIDED|95.0|0.7|1.5|||Generalized linear mixed effects model||Odds ratio is for MK-6096 / Placebo. The generalized linear mixed effects model included terms for treatment, time, treatment-by-time interaction, monthly migraine days during the Treatment Period 1 (≤8, \>8) as covariates.|||1.5|0.7|0.97370
70886689|NCT03732638|141259561|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.0099|TWO_SIDED|95.0|-1.46|-0.2|||Mixed Models Analysis|||||-0.20|-1.46|0.0099
70886690|NCT03732638|141259562|SUPERIORITY||Risk Difference (RD)|7.6||||0.0438|TWO_SIDED|95.0|0.2|14.9|||Cochran-Mantel-Haenszel|||||14.9|0.2|0.0438
70886691|NCT03732638|141259563|SUPERIORITY||Mean Difference (Net)|-0.8||||0.0017|TWO_SIDED|95.0|-1.34|-0.31|||Mixed Models Analysis|||||-0.31|-1.34|0.0017
70886692|NCT03732638|141259564|SUPERIORITY||Mean Difference (Net)|-0.2||||0.3868|TWO_SIDED|95.0|-0.8|0.31||P-value ≥ 0.05; therefore, all secondary endpoints listed after this endpoint in the hierarchy were not tested.|Mixed Models Analysis|||||0.31|-0.80|0.3868
70886693|NCT01034397|141259589|SUPERIORITY_OR_OTHER|||||||1||||||Wrist region: Tocilizumab versus placebo; Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided|||||||1.00
70886694|NCT01034397|141259589|SUPERIORITY_OR_OTHER|||||||0.026||||||2nd and 5th MCP joints: Tocilizumab versus placebo|t-test, 1 sided|||||||0.026
70886695|NCT01034397|141259589|SUPERIORITY_OR_OTHER|||||||1||||||Total synovitis score: Tocilizumab versus placebo; Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided|||||||1.00
70886696|NCT01034397|141259590|SUPERIORITY_OR_OTHER|||||||0.421||||||Percentage Change in OMERACT RAMRIS global score; Tocilizumab versus placebo.|t-test, 1 sided|||||||0.421
70886697|NCT01034397|141259591|SUPERIORITY_OR_OTHER|||||||0.434||||||Absolute change in OMERACT RAMRIS global score; Placebo versus Tocilizumab|t-test, 1 sided|||||||0.434
70886698|NCT01034397|141259594|SUPERIORITY_OR_OTHER|||||||1||||||Change in Wrist region; Tocilizumab versus placebo. Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided|||||||1.00
70886699|NCT01034397|141259594|SUPERIORITY_OR_OTHER|||||||0.065||||||Change in 2nd to 5th MCP; Tocilizumab versus placebo.|t-test, 1 sided|||||||0.065
70886700|NCT01034397|141259594|SUPERIORITY_OR_OTHER|||||||1||||||Change in Total synovitis; Tocilizumab versus placebo. Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided|||||||1.00
70886701|NCT01034397|141259596|SUPERIORITY_OR_OTHER|||||||1||||||Absolute Change in Bone erosion; Tocilizumab versus placebo. Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided|||||||1.00
70886702|NCT01034397|141259597|SUPERIORITY_OR_OTHER|||||||1||||||Percentage Change in Bone erosion; Tocilizumab versus placebo. Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided|||||||1.00
70886703|NCT01034397|141259600|SUPERIORITY_OR_OTHER|||||||0.266||||||Percentage Change in Bone oedema; Tocilizumab versus placebo.|t-test, 1 sided|||||||0.266
70886704|NCT01034397|141259601|SUPERIORITY_OR_OTHER|||||||0.337||||||Absolute Change in Bone edema; Tocilizumab versus placebo.|t-test, 1 sided|||||||0.337
70886705|NCT01034397|141259604|SUPERIORITY_OR_OTHER|||||||0.114||||||Percentage change in DCE-MRI EER (global); Placebo versus Tocilizumab|t-test, 1 sided|||||||0.114
70886706|NCT01034397|141259605|SUPERIORITY_OR_OTHER|||||||0.239||||||Absolute Change in DCE-MRI EER; Tocilizumab versus placebo.|t-test, 1 sided|||||||0.239
70886707|NCT01034397|141259608|SUPERIORITY_OR_OTHER|||||||0.271||||||Percentage change in DCE-MRI EER (MCP); Placebo versus Tocilizumab|t-test, 1 sided|||||||0.271
70886708|NCT01034397|141259609|SUPERIORITY_OR_OTHER|||||||0.37||||||Absolute change in DCE-MRI EER (MCP); Placebo versus Tocilizumab|t-test, 1 sided|||||||0.370
70886709|NCT01034397|141259612|SUPERIORITY_OR_OTHER|||||||1||||||Percentage and absolute change in DCE-MRI EER (wrist); Placebo versus Tocilizumab|t-test, 1 sided|||||||1.00
70886710|NCT01034397|141259617|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
70886711|NCT01034397|141259620|SUPERIORITY_OR_OTHER|||||||0.067|||||||t-test, 1 sided|||||||0.067
70886712|NCT01034397|141259622|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 1 sided|||||||0.001
70886713|NCT01034397|141259624|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 1 sided|||||||0.002
70886714|NCT01034397|141259626|SUPERIORITY_OR_OTHER||||||<|0.001||||||Change from Baseline to Week 12|Friedman's T test|||||||<0.001
70886715|NCT01034397|141259626|SUPERIORITY_OR_OTHER|||||||0.5||||||Change from Baseline to Week 12|Friedman's T test|||||||0.500
70886716|NCT01034397|141259627|SUPERIORITY_OR_OTHER|||||||0.007|||||||t-test, 1 sided|||||||0.007
70886717|NCT01034397|141259630|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 1 sided|||||||0.001
70886718|NCT01034397|141259632|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 1 sided|||||||0.002
70886719|NCT01034397|141259634|SUPERIORITY_OR_OTHER|||||||0.118|||||||t-test, 1 sided|||||||0.118
70886720|NCT01034397|141259636|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 1 sided|||||||1.00
70886721|NCT01034397|141259638|SUPERIORITY_OR_OTHER|||||||0.437|||||||t-test, 1 sided|||||||0.437
70886722|NCT01034397|141259639|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 1 sided|||||||1.00
70886723|NCT01034397|141259642|SUPERIORITY_OR_OTHER|||||||0.19|||||||t-test, 1 sided|||||||0.190
70886724|NCT01034397|141259644|SUPERIORITY_OR_OTHER|||||||0.051|||||||t-test, 1 sided|||||||0.051
70886725|NCT01018264|141259646|SUPERIORITY_OR_OTHER_LEGACY||Effect size|0.2||||0.53|TWO_SIDED||||||ANCOVA|Adjusted for baseline value|This represents the effect size between solifenacin and placebo.|||||0.53
70886726|NCT01018264|141259647|SUPERIORITY_OR_OTHER_LEGACY||Effect size|0.53||||0.01|TWO_SIDED||||||ANCOVA|||||||0.01
70886727|NCT01018264|141259648|SUPERIORITY_OR_OTHER_LEGACY||Effect size|0.35||||0.22|TWO_SIDED||||||ANCOVA|||||||0.22
70886728|NCT01018264|141259649|SUPERIORITY_OR_OTHER_LEGACY||Effect size|0.27||||0.47|TWO_SIDED||||||ANCOVA|||||||0.47
70886729|NCT01018264|141259650|SUPERIORITY_OR_OTHER_LEGACY||Effect size|0.11||||0.94|TWO_SIDED||||||ANCOVA|||||||0.94
70886730|NCT03915548|141259671|OTHER|Group by time interaction (difference in trajectory)||||||0.54||||||Adjusted|Mixed Models Analysis|multiple-degree-of-freedom test|||F(3,747)=0.88|||.54
70886731|NCT03915548|141259672|OTHER|Group by time interaction (difference in trajectory)||||||0.09||||||Adjusted|Mixed Models Analysis|multiple-degree-of-freedom test|||F(3,746.4)=2.64|||.09
70886732|NCT03915548|141259673|OTHER|Group by time interaction (difference in trajectory)||||||0.55||||||Adjusted|Mixed Models Analysis|Poisson model with log link; multiple-degree-of-freedom test|||F(3,717)=0.7|||.55
70886733|NCT03915548|141259674|OTHER|Group by time interaction (difference in trajectory)||||||0.99||||||Adjusted|Mixed Models Analysis|multiple-degree-of-freedom test|||F(3,394.7)=0.18|||.99
70886734|NCT03915548|141259675|OTHER|Group by time interaction (difference in trajectory)||||||0.99||||||Overall score adjusted P = 0.99 Physical subscale adjusted P = 0.99 Social subscale adjusted P = 0.99 Emotional subscale adjusted P = 0.99 Functional subscale adjusted P = 0.99|Mixed Models Analysis|multiple-degree-of-freedom test|||"Group by time interaction:~Overall score: F(3,731.3)=0.03 Physical subscale: F(3,744.5)=0.23 Social subscale: F(3,740.6)=0.32 Emotional subscale: F(3,743)=0.46 Functional subscale: F(3,746.1)=0.3"|||0.99
70886735|NCT03915548|141259676|OTHER|Group by time interaction (difference in trajectory)||||||0.99||||||Active coping adjusted P = 0.99 Planning adjusted P = 0.21 Positive reframing adjusted P = 0.99|Mixed Models Analysis|multiple-degrees-of-freedom test|||Active planning: F(3,746)=0.8 Planning: F(3,744.8)=2.93 Positive reframing = F(3,742)=0.21|||0.99
70886736|NCT03915548|141259677|OTHER|Group by time interaction (difference in trajectory)||||||0.02|||||||Mixed Models Analysis|multiple-degrees-of-freedom test|||Disengagement: F(3,741.2)=5.09 Reengagement: F(3,745.7)=0.81|||0.02
70886737|NCT03915548|141259678|OTHER|Group by time interaction (difference in trajectory)||||||0.99||||||Anxiety adjusted P = 0.99 Depression adjusted P = 0.99|Mixed Models Analysis|multiple-degrees-of-freedom test|||Anxiety: F(3,737.5)=0.17 Depression: F(3,733.6)=0.85|||0.99
70886738|NCT03915548|141259679|SUPERIORITY||Cohen's d|0.26||||0.09|TWO_SIDED|95.0|-0.01|0.54||Importance subscale: Adjusted P = .09 Performance subscale: Adjusted P = \<.001 Satisfaction subscale: Adjusted P = \<.001|Mixed Models Analysis|multiple-degrees-of-freedom test|Importance subscale: Cohen's d = 0.26 (-.01, 0.54) Performance subscale: Cohen's d = 0.60 (0.32, 0.87) Satisfaction subscale: Cohen's d = 0.76 (0.48, 1.02)|||0.54|-.01|.09
70886739|NCT03217136|141259680|OTHER|The Miettinen \& Nurminen method was used.|Difference in Percentage|18.1|||||TWO_SIDED|95.0|-2.6|41.1||||||Difference in Percentage (C/T+MTZ minus MERO)||41.1|-2.6|
70886740|NCT03217136|141259681|OTHER|The Miettinen \& Nurminen method was used.|Difference in Percentage|2.9|||||TWO_SIDED|95.0|-12.9|9.9||||||Difference in Percentage (C/T+MTZ minus MERO)||9.9|-12.9|
70886741|NCT03217136|141259682|OTHER|The difference in percentage was based on the Miettinen \& Nurminen method stratified by age group with Cochran-Mantel-Haenszel (CMH) weights. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Difference in Percentage|-14.3|||||TWO_SIDED|95.0|-26.67|4.93||||||Difference in Percentage (C/T+MTZ minus MERO)||4.93|-26.67|
70886742|NCT03217136|141259683|OTHER|The difference in percentage was based on the Miettinen \& Nurminen method stratified by age group with Cochran-Mantel-Haenszel (CMH) weights. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Difference in Percentage|-19.1|||||TWO_SIDED|95.0|-30.18|-2.89||||||Difference in Percentage (C/T+MTZ minus MERO)||-2.89|-30.18|
70886743|NCT03217136|141259684|OTHER|The difference in percentage was based on the Miettinen \& Nurminen method stratified by age group with Cochran-Mantel-Haenszel (CMH) weights. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Difference in Percentage|-11.2|||||TWO_SIDED|95.0|-23.66|9.61||||||Difference in Percentage (C/T+MTZ minus MERO)||9.61|-23.66|
70886744|NCT03217136|141259685|OTHER|The difference in percentage was based on the Miettinen \& Nurminen method stratified by age group with Cochran-Mantel-Haenszel (CMH) weights. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Difference in Percentage|-16.3|||||TWO_SIDED|95.0|-27.59|1.39||||||Difference in Percentage (C/T+MTZ minus MERO)||1.39|-27.59|
70886745|NCT03670810|141259690|SUPERIORITY||Odds Ratio (OR)|3.83|||<|0.001|TWO_SIDED|95.0|2.56|5.73|||Regression, Logistic|||||5.73|2.56|<0.001
70886746|NCT03670810|141259690|SUPERIORITY||Odds Ratio (OR)|4.56|||<|0.001|TWO_SIDED|95.0|3.07|6.77|||Regression, Logistic|||||6.77|3.07|<0.001
70886747|NCT03670810|141259691|SUPERIORITY||Odds Ratio (OR)|3.77|||<|0.001|TWO_SIDED|95.0|2.1|6.76|||Regression, Logistic|||||6.76|2.10|<.001
70886748|NCT03670810|141259691|SUPERIORITY||Odds Ratio (OR)|7.24|||<|0.001|TWO_SIDED|95.0|4.13|12.67|||Regression, Logistic|||||12.67|4.13|<.001
70886749|NCT03670810|141259692|SUPERIORITY||Odds Ratio (OR)|2.71|||<|0.001|TWO_SIDED|95.0|2.05|3.57|||Regression, Logistic|||||3.57|2.05|<0.001
70886750|NCT03670810|141259692|SUPERIORITY||Odds Ratio (OR)|2.68|||<|0.001|TWO_SIDED|95.0|2.04|3.53|||Regression, Logistic|||||3.53|2.04|<0.001
70886751|NCT03670810|141259693|SUPERIORITY||Odds Ratio (OR)|2.91|||<|0.001|TWO_SIDED|95.0|2.11|4.01|||Regression, Logistic|||||4.01|2.11|<0.001
70886752|NCT03670810|141259693|SUPERIORITY||Odds Ratio (OR)|3.5|||<|0.001|TWO_SIDED|95.0|2.53|4.85|||Regression, Logistic|||||4.85|2.53|<0.001
70886753|NCT03670810|141259694|SUPERIORITY||Odds Ratio (OR)|3.52|||<|0.001|TWO_SIDED|95.0|2.05|6.02|||Regression, Logistic|||||6.02|2.05|<0.001
70886754|NCT03670810|141259694|SUPERIORITY||Odds Ratio (OR)|4.67|||<|0.001|TWO_SIDED|95.0|2.77|7.88|||Regression, Logistic|||||7.88|2.77|<0.001
70886755|NCT03670810|141259695|SUPERIORITY||Odds Ratio (OR)|2.3||||0.004|TWO_SIDED|95.0|1.3|4.04|||Regression, Logistic|||||4.04|1.30|0.004
70886756|NCT03670810|141259695|SUPERIORITY||Odds Ratio (OR)|4.09|||<|0.001|TWO_SIDED|95.0|2.41|6.94|||Regression, Logistic|||||6.94|2.41|<0.001
70886757|NCT03670810|141259696|SUPERIORITY||Odds Ratio (OR)|3.29|||<|0.001|TWO_SIDED|95.0|1.8|6.02|||Regression, Logistic|||||6.02|1.80|<0.001
70886758|NCT03670810|141259696|SUPERIORITY||Odds Ratio (OR)|3.56|||<|0.001|TWO_SIDED|95.0|1.97|6.42|||Regression, Logistic|||||6.42|1.97|<0.001
70886759|NCT03670810|141259697|SUPERIORITY||Odds Ratio (OR)|2.22|||<|0.001|TWO_SIDED|95.0|1.48|3.33|||Regression, Logistic|||||3.33|1.48|<0.001
70886760|NCT03670810|141259697|SUPERIORITY||Odds Ratio (OR)|2.46|||<|0.001|TWO_SIDED|95.0|1.65|3.67|||Regression, Logistic|||||3.67|1.65|<0.001
70886761|NCT03670810|141259698|SUPERIORITY||Odds Ratio (OR)|2.73||||0.031|TWO_SIDED|95.0|1.1|6.78|||Regression, Logistic|||||6.78|1.10|0.031
70886762|NCT03670810|141259698|SUPERIORITY||Odds Ratio (OR)|5.64|||<|0.001|TWO_SIDED|95.0|2.4|13.25|||Regression, Logistic|||||13.25|2.40|<0.001
70886763|NCT03670810|141259699|SUPERIORITY||Odds Ratio (OR)|1.74|||<|0.001|TWO_SIDED|95.0|1.29|2.35|||Regression, Logistic|||||2.35|1.29|<0.001
70886764|NCT03670810|141259699|SUPERIORITY||Odds Ratio (OR)|1.63||||0.001|TWO_SIDED|95.0|1.21|2.2|||Regression, Logistic|||||2.20|1.21|0.001
70886765|NCT03670810|141259700|SUPERIORITY||Odds Ratio (OR)|0.46|||<|0.001|TWO_SIDED|95.0|0.33|0.65|||Regression, Logistic|||||0.65|0.33|<0.001
70886766|NCT03670810|141259700|SUPERIORITY||Odds Ratio (OR)|0.43|||<|0.001|TWO_SIDED|95.0|0.3|0.6|||Regression, Logistic|||||0.60|0.30|<0.001
70886767|NCT03670810|141259701|SUPERIORITY||Odds Ratio (OR)|2.77|||<|0.001|TWO_SIDED|95.0|1.79|4.28|||Regression, Logistic|||||4.28|1.79|<0.001
70886768|NCT03670810|141259701|SUPERIORITY||Odds Ratio (OR)|3.37|||<|0.001|TWO_SIDED|95.0|2.2|5.15|||Regression, Logistic|||||5.15|2.20|<0.001
70886769|NCT03670810|141259703|SUPERIORITY||Odds Ratio (OR)|6.4||||0.086|TWO_SIDED|95.0|0.77|53.37|||Regression, Logistic|||Pain Freedom 30 Min. Postdose||53.37|0.77|0.086
70886770|NCT03670810|141259703|SUPERIORITY||Odds Ratio (OR)|7.24||||0.065|TWO_SIDED|95.0|0.89|59.08|||Regression, Logistic|||Pain Freedom 30 Min. Postdose||59.08|0.89|0.065
70886771|NCT03670810|141259703|SUPERIORITY||Odds Ratio (OR)|3.08||||0.004|TWO_SIDED|95.0|1.42|6.68|||Regression, Logistic|||Pain Free 1 Hour Postdose||6.68|1.42|0.004
70886772|NCT03670810|141259703|SUPERIORITY||Odds Ratio (OR)|7.04|||<|0.001|TWO_SIDED|95.0|3.43|14.44|||Regression, Logistic|||Pain Free 1 Hour Postdose||14.44|3.43|<0.001
70886773|NCT03670810|141259703|SUPERIORITY||Odds Ratio (OR)|1.41||||0.065|TWO_SIDED|95.0|0.98|2.03|||Regression, Logistic|||Pain Relief 30 Min Postdose 100 mg||2.03|0.98|0.065
70886774|NCT03670810|141259703|SUPERIORITY||Odds Ratio (OR)|1.77||||0.001|TWO_SIDED|95.0|1.25|2.52|||Regression, Logistic|||Pain Relief 30 Min. Postdose 200 mg||2.52|1.25|0.001
70886775|NCT03670810|141259703|SUPERIORITY||Odds Ratio (OR)|2.31|||<|0.001|TWO_SIDED|95.0|1.74|3.06|||Regression, Logistic|||Pain Relief 1 Hour Postdose 100 mg||3.06|1.74|<0.001
70886776|NCT03670810|141259703|SUPERIORITY||Odds Ratio (OR)|2.18|||<|0.001|TWO_SIDED|95.0|1.64|2.88|||Regression, Logistic|||Pain Relief 1 Hour Postdose 200 mg||2.88|1.64|<0.001
70886777|NCT03670810|141259703|SUPERIORITY||Odds Ratio (OR)|1.11||||0.651|TWO_SIDED|95.0|0.71|1.71|||Regression, Logistic|||Freedom from MBS 30 Min 100 mg||1.71|0.71|0.651
70886778|NCT03670810|141259703|SUPERIORITY||Odds Ratio (OR)|1.3||||0.22|TWO_SIDED|95.0|0.85|1.98|||Regression, Logistic|||Freedom from MBS 30 Min. 200 mg||1.98|0.85|0.220
70886779|NCT03670810|141259703|SUPERIORITY||Odds Ratio (OR)|1.1||||0.593|TWO_SIDED|95.0|0.78|1.54|||Regression, Logistic|||Freedom from MBS 1 Hour 100 mg||1.54|0.78|0.593
70886780|NCT03670810|141259703|SUPERIORITY||Odds Ratio (OR)|1.43||||0.03|TWO_SIDED|95.0|1.04|1.98|||Regression, Logistic|||Freedom from MBS 1 Hour 200 mg||1.98|1.04|0.030
70886781|NCT03670810|141259704|SUPERIORITY|||||||0.092|||||||ANCOVA|||||||0.092
70886782|NCT03670810|141259704|SUPERIORITY|||||||0.211|||||||ANCOVA|||||||0.211
70886783|NCT03670810|141259705|SUPERIORITY||Odds Ratio (OR)|2.85|||<|0.001|TWO_SIDED|95.0|2.01|4.05|||Regression, Logistic|||||4.05|2.01|<0.001
70886784|NCT03670810|141259705|SUPERIORITY||Odds Ratio (OR)|3.0|||<|0.001|TWO_SIDED|95.0|2.12|4.26|||Regression, Logistic|||||4.26|2.12|<0.001
70886785|NCT03670810|141259706|SUPERIORITY|||||||0.056|||||||ANOVA|||Social Functioning||||0.056
70886786|NCT03670810|141259706|SUPERIORITY|||||||0.267|||||||ANOVA|||Social Functioning||||0.267
70886787|NCT03670810|141259706|SUPERIORITY|||||||0.003|||||||ANOVA|||Migraine Symptoms 100 mg||||0.003
70886788|NCT03670810|141259706|SUPERIORITY|||||||0.002|||||||ANOVA|||Migraine Symptoms 200 mg||||0.002
70886789|NCT03670810|141259706|SUPERIORITY|||||||0.014|||||||ANOVA|||Feeling/Concerns 100 mg||||0.014
70886790|NCT03670810|141259706|SUPERIORITY|||||||0.018|||||||ANOVA|||Feelings/Concerns 200 mg||||0.018
70886791|NCT03670810|141259707|SUPERIORITY||Odds Ratio (OR)|1.25||||0.101|TWO_SIDED|95.0|0.96|1.62|||Regression, Logistic|||Recommend Treatment - Agree Strongly Agree||1.62|0.96|0.101
70886792|NCT03670810|141259707|SUPERIORITY||Odds Ratio (OR)|1.28||||0.063|TWO_SIDED|95.0|0.99|1.67|||Regression, Logistic|||Recommend Treatment Agree/Strongly Agree||1.67|0.99|0.063
70886793|NCT03670810|141259707|SUPERIORITY||Odds Ratio (OR)|0.89||||0.376|TWO_SIDED|95.0|0.68|1.16|||Regression, Logistic|||Willing to Take This Treatment Again - Agree/Strongly Agree||1.16|0.68|0.376
70886794|NCT03670810|141259707|SUPERIORITY||Odds Ratio (OR)|0.79||||0.082|TWO_SIDED|95.0|0.6|1.03|||Regression, Logistic|||Willing to Take This Treatment Again - Agree/Strongly Agree||1.03|0.60|0.082
70886795|NCT03670810|141259707|SUPERIORITY||Odds Ratio (OR)|1.25||||0.096|TWO_SIDED|95.0|0.96|1.62|||Regression, Logistic|||Extremely/Very Satisfied||1.62|0.96|0.096
70886796|NCT03670810|141259707|SUPERIORITY||Odds Ratio (OR)|1.38||||0.016|TWO_SIDED|95.0|1.06|1.8|||Regression, Logistic|||Extremely/Very Satisfied||1.80|1.06|0.016
70886797|NCT03670810|141259707|SUPERIORITY||Odds Ratio (OR)|1.12||||0.445|TWO_SIDED|95.0|0.84|1.49|||Regression, Logistic|||Prefer This Treatment||1.49|0.84|0.445
70886798|NCT03670810|141259707|SUPERIORITY||Odds Ratio (OR)|1.19||||0.243|TWO_SIDED|95.0|0.89|1.58|||Regression, Logistic|||||1.58|0.89|0.243
70886799|NCT03670810|141259708|SUPERIORITY|||||||0.142|||||||ANCOVA|||||||0.142
70886800|NCT03670810|141259709|SUPERIORITY||Odds Ratio (OR)|3.01||||0.004|TWO_SIDED|95.0|1.42|6.4|||Regression, Logistic|||||6.40|1.42|0.004
70886801|NCT03670810|141259709|SUPERIORITY||Odds Ratio (OR)|4.58|||<|0.001|TWO_SIDED|95.0|2.22|9.47|||Regression, Logistic|||||9.47|2.22|<0.001
70886802|NCT03670810|141259710|SUPERIORITY||Odds Ratio (OR)|2.51|||<|0.001|TWO_SIDED|95.0|1.74|3.62|||Regression, Logistic|||||3.62|1.74|<0.001
70886803|NCT03670810|141259710|SUPERIORITY||Odds Ratio (OR)|3.61|||<|0.001|TWO_SIDED|95.0|2.5|5.2|||Regression, Logistic|||||5.20|2.50|<0.001
70886804|NCT03670810|141259711|SUPERIORITY||Odds Ratio (OR)|1.01||||0.953|TWO_SIDED|95.0|0.75|1.36|||Regression, Logistic|||Nausea||1.36|0.75|0.953
70886805|NCT03670810|141259711|SUPERIORITY||Odds Ratio (OR)|1.05||||0.768|TWO_SIDED|95.0|0.78|1.41|||Regression, Logistic|||Nausea||1.41|0.78|0.768
70886806|NCT03670810|141259711|SUPERIORITY||Odds Ratio (OR)|0.53|||<|0.001|TWO_SIDED|95.0|0.39|0.71|||Regression, Logistic|||Phonophobia||0.71|0.39|<0.001
70886807|NCT03670810|141259711|SUPERIORITY||Odds Ratio (OR)|0.46|||<|0.001|TWO_SIDED|95.0|0.34|0.62|||Regression, Linear|||Phonophobia||0.62|0.34|<0.001
70886808|NCT03670810|141259711|SUPERIORITY||Odds Ratio (OR)|0.48|||<|0.001|TWO_SIDED|95.0|0.36|0.63|||Regression, Logistic|||Photophobia||0.63|0.36|<0.001
70886809|NCT03670810|141259711|SUPERIORITY||Median Difference (Net)|0.53|||<|0.001|TWO_SIDED|95.0|0.4|0.71|||Regression, Logistic|||Photophobia||0.71|0.40|<0.001
70886810|NCT03670810|141259711|SUPERIORITY||Odds Ratio (OR)|0.46||||0.129|TWO_SIDED|95.0|0.17|1.25|||Regression, Logistic|||Vomiting||1.25|0.17|0.129
70886811|NCT03670810|141259711|SUPERIORITY||Odds Ratio (OR)|1.12||||0.769|TWO_SIDED|95.0|0.52|2.43|||Regression, Logistic|||Vomiting||2.43|0.52|0.769
70886812|NCT03192150|141259712|SUPERIORITY|Statistical hypotheses testing for the primary efficacy endpoint was two-sided and performed using a significance (alpha) level of 0.05.|||||<|0.0001||||||P-values were from a Chi-Square test (with continuity correction) of differences between treatments in the proportion of participants with ACC Grade 0 who did not receive rescue medication versus all other grades combined.|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||||||< 0.0001
70886813|NCT03192150|141259713|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|2.311||||0.0054|TWO_SIDED|95.0|1.311|4.074||P-values were from a Chi-Square test with continuity correction.|Chi-squared, Corrected|A Fisher's exact test was used if ≥ 1 of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 1||4.074|1.311|0.0054
70886814|NCT03192150|141259713|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|3.581|||<|0.0001|TWO_SIDED|95.0|1.967|6.519||P-values were from a Chi-Square test with continuity correction.|Chi-squared, Corrected|A Fisher's exact test was used if ≥ 1 of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 8||6.519|1.967|< 0.0001
70886815|NCT03192150|141259713|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|3.503|||<|0.0001|TWO_SIDED|95.0|1.909|6.426||P-values were from a Chi-Square test with continuity correction.|Chi-squared, Corrected|A Fisher's exact test was used if ≥ 1 of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 15||6.426|1.909|< 0.0001
70886816|NCT03192150|141259713|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|3.659|||<|0.0001|TWO_SIDED|95.0|1.987|6.736||P-values were from a Chi-Square test with continuity correction.|Chi-squared, Corrected|A Fisher's exact test was used if ≥ 1 of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 18||6.736|1.987|< 0.0001
70886817|NCT03192150|141259713|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|2.952||||0.0008|TWO_SIDED|95.0|1.596|5.462||P-values were from a Chi-Square test with continuity correction.|Chi-squared, Corrected|A Fisher's exact test was used if ≥ 1 of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 29||5.462|1.596|0.0008
70886818|NCT04875520|141259733|NON_INFERIORITY|Overall rate compared using GEE model includes any person affiliated with the school who tested positive at least once during the study period that the schools reported to us that were positive. This includes people in our testing program and not in our testing program.|Mean Difference (Final Values)|-0.01845||||0.25|TWO_SIDED|95.0|-0.04981|0.01292|||generalized estimating equations|||||0.01292|-0.04981|0.25
70886819|NCT05773287|141259749|SUPERIORITY|||||||0.509||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.509
70886820|NCT05773287|141259750|SUPERIORITY|||||||0.552||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.552
70886821|NCT03523117|141259767|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.3108|TWO_SIDED||||||ANCOVA|||||||0.3108
70886822|NCT03523117|141259768|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.0001|TWO_SIDED||||||ANCOVA|||||||0.0001
70886823|NCT03523117|141259769|SUPERIORITY||Mean Difference (Final Values)|15.64||||0.0001|TWO_SIDED||||||ANCOVA|||||||0.0001
70886824|NCT03523117|141259770|SUPERIORITY||Mean Difference (Final Values)|2.06||||0.0002|TWO_SIDED||||||Mixed Models Analysis|||||||0.0002
70886825|NCT02644967|141259783|OTHER|Estimation||||||0.0158||||||P-value of the overall response tested against the null rate of 11% based on 1-sided exact (Clopper-Pearson) test.|One-sided Clopper-Pearson test|||Testing the best overall confirmed response rate against the historical control rate of 0.11 (extracted from the literature review).||||0.0158
70886826|NCT02644967|141259784|OTHER|Estimation|Kaplan-Meier|5.06|||||TWO_SIDED|95.0|3.65|7.0|||||Kaplan-Meier estimate of median PFS in months.|||7.00|3.65|
70886827|NCT02644967|141259785|OTHER|Landmark analysis of overall survival at six (6) months.|Kaplan-Meier|87.5|||||TWO_SIDED|95.0|74.3|94.2|||||Kaplan-Meier estimate of percentage of participants surviving at six (6) months.|||94.2|74.3|
70886828|NCT02644967|141259786|OTHER|Landmark analysis of overall survival at twelve (12) months.|Kaplan-Meier|60.0|||||TWO_SIDED|95.0|44.7|72.4|||||Kaplan-Meier estimate of percentage of participants surviving at twelve (12) months.|||72.4|44.7|
70886829|NCT03254134|141259808|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.534|0.97||||||There was no formal hypothesis testing.|The hazard ratio of stroke for the dabigatran group as compared to the warfarin group and its 95% CI were estimated from the propensity score matched group using a Cox regression model with treatment group as the dependent variable|0.970|0.534|
70886830|NCT03254134|141259809|SUPERIORITY||Hazard Ratio (HR)|0.549|||||TWO_SIDED|95.0|0.303|0.994||||||There was no formal hypothesis testing.|The hazard ratio of systemic embolism for the dabigatran group as compared to the warfarin group and its 95% CI were estimated from the propensity score matched group using a Cox regression model with treatment group as the dependent variable|0.994|0.303|
70886831|NCT03385239|141259821|SUPERIORITY||Mean Difference in % CFB|-27.0||||0.0042|TWO_SIDED|95.0|-41.0|-10.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|||-10|-41|0.0042
70886832|NCT03385239|141259821|SUPERIORITY||Mean Difference in % CFB|-58.0|||<|0.0001|TWO_SIDED|95.0|-66.0|-48.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-48|-66|<0.0001
70886833|NCT03385239|141259821|SUPERIORITY||Mean Difference in % CFB|-63.0|||<|0.0001|TWO_SIDED|95.0|-70.0|-54.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-54|-70|<0.0001
70886834|NCT03385239|141259821|SUPERIORITY||Mean Difference in % CFB|-62.0|||<|0.0001|TWO_SIDED|95.0|-69.0|-53.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-53|-69|<0.0001
70886835|NCT03385239|141259823|SUPERIORITY||Mean Difference in % CFB|-30.0||||0.0123|TWO_SIDED|95.0|-47.0|-8.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoC III||-8|-47|0.0123
70886836|NCT03385239|141259823|SUPERIORITY||Mean Difference in % CFB|-68.0|||<|0.0001|TWO_SIDED|95.0|-76.0|-58.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Apo-C III||-58|-76|<0.0001
70886837|NCT03385239|141259823|SUPERIORITY||Mean Difference in % CFB|-74.0|||<|0.0001|TWO_SIDED|95.0|-80.0|-65.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Apo-C III||-65|-80|<0.0001
70886838|NCT03385239|141259823|SUPERIORITY||Mean Difference in % CFB|-74.0|||<|0.0001|TWO_SIDED|95.0|-80.0|-66.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Apo-C III||-66|-80|<0.0001
70886839|NCT03385239|141259823|SUPERIORITY||Mean Difference in % CFB|-3.0||||0.568|TWO_SIDED|95.0|-11.0|7.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|TC||7|-11|0.568
70886840|NCT03385239|141259823|SUPERIORITY||Mean Difference in % CFB|-12.0||||0.008|TWO_SIDED|95.0|-19.0|-3.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|TC||-3|-19|0.008
70886841|NCT03385239|141259823|SUPERIORITY||Mean Difference in % CFB|-3.0||||0.4476|TWO_SIDED|95.0|-12.0|6.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|TC||6|-12|0.4476
70886842|NCT03385239|141259823|SUPERIORITY||Mean Difference in % CFB|-8.0||||0.0606|TWO_SIDED|95.0|-16.0|0.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|TC||0|-16|0.0606
70886843|NCT03385239|141259823|SUPERIORITY||Mean Difference in % CFB|7.0||||0.4509|TWO_SIDED|95.0|-10.0|26.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||26|-10|0.4509
70886844|NCT03385239|141259823|SUPERIORITY||Mean Difference in % CFB|4.0||||0.6746|TWO_SIDED|95.0|-12.0|23.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||23|-12|0.6746
70886845|NCT03385239|141259823|SUPERIORITY||Mean Difference in % CFB|29.0||||0.0032|TWO_SIDED|95.0|9.0|53.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||53|9|0.0032
70886846|NCT03385239|141259823|SUPERIORITY||Mean Difference in % CFB|12.0||||0.1996|TWO_SIDED|95.0|-6.0|32.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||32|-6|0.1996
70886847|NCT03385239|141259823|SUPERIORITY||Mean Difference in % CFB|12.0||||0.0373|TWO_SIDED|95.0|1.0|24.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||24|1|0.0373
70886848|NCT03385239|141259823|SUPERIORITY||Mean Difference in % CFB|34.0|||<|0.0001|TWO_SIDED|95.0|21.0|49.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||49|21|<0.0001
70886849|NCT03385239|141259823|SUPERIORITY||Mean Difference in % CFB|42.0|||<|0.0001|TWO_SIDED|95.0|28.0|57.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||57|28|<0.0001
70886850|NCT03385239|141259823|SUPERIORITY||Mean Difference in % CFB|30.0|||<|0.0001|TWO_SIDED|95.0|18.0|44.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||44|18|<0.0001
70886851|NCT03385239|141259823|SUPERIORITY||Mean Difference in % CFB|-7.0||||0.2826|TWO_SIDED|95.0|-18.0|6.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||6|-18|0.2826
70886852|NCT03385239|141259823|SUPERIORITY||Mean Difference in % CFB|-24.0|||<|0.0001|TWO_SIDED|95.0|-34.0|-14.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||-14|-34|<0.0001
70886853|NCT03385239|141259823|SUPERIORITY||Mean Difference in % CFB|-15.0||||0.0118|TWO_SIDED|95.0|-26.0|-4.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||-4|-26|0.0118
70886854|NCT03385239|141259823|SUPERIORITY||Mean Difference in % CFB|-20.0||||0.0009|TWO_SIDED|95.0|-29.0|-9.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||-9|-29|0.0009
70886855|NCT03385239|141259823|SUPERIORITY||Mean Difference in % CFB|-21.0||||0.0086|TWO_SIDED|95.0|-34.0|-6.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-6|-34|0.0086
70886856|NCT03385239|141259823|SUPERIORITY||Mean Difference in % CFB|-53.0|||<|0.0001|TWO_SIDED|95.0|-60.0|-44.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-44|-60|<0.0001
70886857|NCT03385239|141259823|SUPERIORITY||Mean Difference in % CFB|-58.0|||<|0.0001|TWO_SIDED|95.0|-64.0|-50.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-50|-64|<0.0001
70886858|NCT03385239|141259823|SUPERIORITY||Mean Difference in % CFB|-60.0|||<|0.0001|TWO_SIDED|95.0|-66.0|-52.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-52|-66|<0.0001
70886859|NCT03385239|141259823|SUPERIORITY||Mean Difference in % CFB|2.0||||0.6801|TWO_SIDED|95.0|-7.0|13.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||13|-7|0.6801
70886860|NCT03385239|141259823|SUPERIORITY||Mean Difference in % CFB|-16.0||||0.0007|TWO_SIDED|95.0|-24.0|-7.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||-7|-24|0.0007
70886861|NCT03385239|141259823|SUPERIORITY||Mean Difference in % CFB|-5.0||||0.3183|TWO_SIDED|95.0|-14.0|5.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||5|-14|0.3183
70886862|NCT03385239|141259823|SUPERIORITY||Mean Difference in % CFB|-10.0||||0.024|TWO_SIDED|95.0|-19.0|-1.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||-1|-19|0.024
70886863|NCT03385239|141259823|SUPERIORITY||Mean Difference in % CFB|5.0||||0.0936|TWO_SIDED|95.0|-1.0|11.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoA-I||11|-1|0.0936
70886864|NCT03385239|141259823|SUPERIORITY||Mean Difference in % CFB|14.0|||<|0.0001|TWO_SIDED|95.0|8.0|21.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoA-I||21|8|<0.0001
70886865|NCT03385239|141259823|SUPERIORITY||Mean Difference in % CFB|18.0|||<|0.0001|TWO_SIDED|95.0|11.0|25.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoA-I||25|11|<0.0001
70886866|NCT03385239|141259823|SUPERIORITY||Mean Difference in % CFB|14.0|||<|0.0001|TWO_SIDED|95.0|7.0|20.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoA-I||20|7|<0.0001
70886867|NCT03385239|141259824|SUPERIORITY||Odds Ratio (OR)|3.34||||0.2591|TWO_SIDED|95.0|0.41|27.2|||Regression, Logistic|||||27.20|0.41|0.2591
70886868|NCT03385239|141259824|SUPERIORITY||Odds Ratio (OR)|84.02|||<|0.0001|TWO_SIDED|95.0|9.54|740.02|||Regression, Logistic|||||740.02|9.54|<0.0001
70886869|NCT03385239|141259824|SUPERIORITY||Odds Ratio (OR)|322.79|||<|0.0001|TWO_SIDED|95.0|20.31|5130.99|||Regression, Logistic|||||5130.99|20.31|<0.0001
70886870|NCT03385239|141259824|SUPERIORITY||Odds Ratio (OR)|342.13|||<|0.0001|TWO_SIDED|95.0|23.72|4933.89|||Regression, Logistic|||||4933.89|23.72|<0.0001
70886871|NCT03385239|141259825|SUPERIORITY||Odds Ratio (OR)|1.25||||0.9119|TWO_SIDED|95.0|0.02|69.88|||Regression, Logistic|||||69.88|0.02|0.9119
70886872|NCT03385239|141259825|SUPERIORITY||Odds Ratio (OR)|27.18||||0.0306|TWO_SIDED|95.0|1.36|542.48|||Regression, Logistic|||||542.48|1.36|0.0306
70886873|NCT03385239|141259825|SUPERIORITY||Odds Ratio (OR)|25.54||||0.0344|TWO_SIDED|95.0|1.27|514.2|||Regression, Logistic|||||514.20|1.27|0.0344
70886874|NCT03385239|141259825|SUPERIORITY||Odds Ratio (OR)|44.47||||0.0123|TWO_SIDED|95.0|2.28|866.49|||Regression, Logistic|||||866.49|2.28|0.0123
70886875|NCT01574703|141259829|SUPERIORITY_OR_OTHER|||||||0.37||||||P-value for the treatment effect from the Log-Rank test stratified by Cohort.|Log Rank|||Statistical analysis for overall treatment comparison.||||0.37
70886876|NCT01574703|141259830|SUPERIORITY_OR_OTHER|||||||0.53||||||P-value for the treatment effect from the Log-Rank test stratified by Cohort.|Log Rank|||Statistical analysis for overall treatment comparison.||||0.53
70886877|NCT01574703|141259831|SUPERIORITY_OR_OTHER|||||||0.34||||||P-value for the treatment effect from the Log-Rank test stratified by Cohort.|Log Rank|||Statistical analysis for overall treatment comparison.||||0.34
70886878|NCT01574703|141259832|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.49||||0.8375|TWO_SIDED|95.0|-5.22|4.23||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.||4.23|-5.22|0.8375
70886879|NCT01574703|141259832|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.07||||0.978|TWO_SIDED|95.0|-5.2|5.05||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.||5.05|-5.20|0.9780
70886880|NCT01574703|141259832|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.13||||0.6142|TWO_SIDED|95.0|-5.54|3.27||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.||3.27|-5.54|0.6142
70886881|NCT01574703|141259832|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.42||||0.8602|TWO_SIDED|95.0|-4.28|5.13||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.||5.13|-4.28|0.8602
70886882|NCT01574703|141259832|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.64||||0.7217|TWO_SIDED|95.0|-4.15|2.88||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.||2.88|-4.15|0.7217
70886883|NCT01574703|141259832|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.06||||0.6322|TWO_SIDED|95.0|-5.41|3.28||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.||3.28|-5.41|0.6322
70886884|NCT01574703|141259833|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.07||||0.9687|TWO_SIDED|95.0|-3.48|3.34||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.||3.34|-3.48|0.9687
70886885|NCT01574703|141259833|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.56||||0.7905|TWO_SIDED|95.0|-3.58|4.7||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.||4.70|-3.58|0.7905
70886886|NCT01574703|141259833|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.21||||0.8962|TWO_SIDED|95.0|-3.36|2.94||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.||2.94|-3.36|0.8962
70886887|NCT01574703|141259833|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.63||||0.7767|TWO_SIDED|95.0|-3.72|4.98||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.||4.98|-3.72|0.7767
70886888|NCT01574703|141259833|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.14||||0.926|TWO_SIDED|95.0|-3.13|2.85||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.||2.85|-3.13|0.9260
70886889|NCT01574703|141259833|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.77||||0.7113|TWO_SIDED|95.0|-4.85|3.31||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.||3.31|-4.85|0.7113
70886890|NCT01574703|141259834|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.57||||0.8117|TWO_SIDED|95.0|-5.27|4.13||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.||4.13|-5.27|0.8117
70886891|NCT01574703|141259834|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.78||||0.7303|TWO_SIDED|95.0|-5.21|3.65||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.||3.65|-5.21|0.7303
70886892|NCT01574703|141259834|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.2||||0.5946|TWO_SIDED|95.0|-5.6|3.21||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.||3.21|-5.60|0.5946
70886893|NCT01574703|141259834|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.21||||0.92|TWO_SIDED|95.0|-4.27|3.85||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.||3.85|-4.27|0.9200
70886894|NCT01574703|141259834|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.62||||0.7236|TWO_SIDED|95.0|-4.09|2.84||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.||2.84|-4.09|0.7236
70886895|NCT01574703|141259834|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.42||||0.8201|TWO_SIDED|95.0|-4.01|3.17||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.||3.17|-4.01|0.8201
70886896|NCT01574703|141259835|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.21||||0.8932|TWO_SIDED|95.0|-3.22|2.81||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.||2.81|-3.22|0.8932
70886897|NCT01574703|141259835|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.23||||0.8747|TWO_SIDED|95.0|-3.09|2.63||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.||2.63|-3.09|0.8747
70886898|NCT01574703|141259835|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.6||||0.671|TWO_SIDED|95.0|-3.35|2.15||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.||2.15|-3.35|0.6710
70886899|NCT01574703|141259835|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.02||||0.9886|TWO_SIDED|95.0|-3.32|3.27||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.||3.27|-3.32|0.9886
70886900|NCT01574703|141259835|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.39||||0.7631|TWO_SIDED|95.0|-2.92|2.14||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.||2.14|-2.92|0.7631
70886901|NCT01574703|141259835|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.37||||0.8022|TWO_SIDED|95.0|-3.23|2.5||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.||2.50|-3.23|0.8022
70886902|NCT01574703|141259836|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.91||||0.6441|TWO_SIDED|95.0|-4.78|2.96||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.||2.96|-4.78|0.6441
70886903|NCT01574703|141259836|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.69||||0.7327|TWO_SIDED|95.0|-4.63|3.26||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.||3.26|-4.63|0.7327
70886904|NCT01574703|141259836|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.99||||0.6109|TWO_SIDED|95.0|-4.8|2.82||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.||2.82|-4.80|0.6109
70886905|NCT01574703|141259836|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.22||||0.8707|TWO_SIDED|95.0|-2.48|2.93||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.||2.93|-2.48|0.8707
70886906|NCT01574703|141259836|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.08||||0.9531|TWO_SIDED|95.0|-2.63|2.48||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.||2.48|-2.63|0.9531
70886907|NCT01574703|141259836|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.3||||0.8262|TWO_SIDED|95.0|-2.99|2.39||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.||2.39|-2.99|0.8262
70886908|NCT01574703|141259837|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.59||||0.6105|TWO_SIDED|95.0|-2.84|1.67||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.||1.67|-2.84|0.6105
70886909|NCT01574703|141259837|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.32||||0.7895|TWO_SIDED|95.0|-2.65|2.01||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.||2.01|-2.65|0.7895
70886910|NCT01574703|141259837|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.48||||0.6804|TWO_SIDED|95.0|-2.75|1.8||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.||1.80|-2.75|0.6804
70886911|NCT01574703|141259837|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.27||||0.8127|TWO_SIDED|95.0|-1.95|2.49||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.||2.49|-1.95|0.8127
70886912|NCT01574703|141259837|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.11||||0.9218|TWO_SIDED|95.0|-2.04|2.25||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.||2.25|-2.04|0.9218
70886913|NCT01574703|141259837|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.16||||0.8841|TWO_SIDED|95.0|-2.32|2.0||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.||2.00|-2.32|0.8841
70886914|NCT02915744|141259848|OTHER||ESMO-MCBS (v1.0)|1.0|||||TWO_SIDED|||||||||||||
70886915|NCT00813358|141259850|NON_INFERIORITY|NI=7%|KM product-limit estimator|99.1|||||TWO_SIDED|95.0|97.4|100.0||||||||100|97.4|
70886916|NCT03851016|141259854|SUPERIORITY|||||||0.113|||||||Mancova|||"Null hypothesis is that there would be no difference in change of depressive symptoms between Life Story Book Intervention and Usual Care. A multivariate analysis of covariance (MANCOVA) models with the GDS-12R at baseline as the covariate, and the treatment group and study site as factors. The test was performed with a significance level of 0.05.~A sample size of 20 was needed to provide 90% power to detect a 5 point difference in depressive symptoms."||||.113
70886917|NCT03851016|141259855|SUPERIORITY|||||||0.123|||||||Mancova|||"Null hypothesis is that there would be no difference in change of Presence of Meaning (POM) between Life Story Book Intervention and Usual Care. A multivariate analysis of covariance (MANCOVA) models with the POM at baseline as the covariate, and the treatment group and study site as factors. The test was performed with a significance level of 0.05.~A sample size of 20 was needed to provide 90% power to detect a 5 point difference in POM."||||.123
70886918|NCT03851016|141259856|SUPERIORITY|||||||0.91|||||||Mancova|||"The null hypothesis is that there would be no difference in change of Search for Meaning (SFM) between Life Story Book Intervention and Usual Care. A multivariate analysis of covariance (MANCOVA) models with the SFM at baseline as the covariate, and the treatment group and study site as factors. The test was performed with a significance level of 0.05.~A sample size of 20 was needed to provide 90% power to detect a 5 point difference in SFM."||||.910
70886919|NCT03080961|141259857|OTHER||SADE percentage|0.0|||||TWO_SIDED|95.0|0.0|7.7||||||SADE rate after minimally 26 days of VIBLOK treatment will be assessed by calculating the upper limit of the 2-sided exact 95% Clopper-Pearson confidence interval which needs to be below 10%. With a sample size of 36, an exact two-sided 95.0% confidence interval for a single proportion would show that the SADE incidence is below 10% at an expected incidence of 0.1%.||7.7|0.0|
70886920|NCT03080961|141259858|SUPERIORITY|||||||0.248|||||||Wilcoxon (Mann-Whitney)|||Statistical analysis will evaluate the difference in detection rate between pre and post-VIBLOK swabs. For each person the number of swabs with shedding only pre-VIBLOK will be assessed, and then the number of swabs with shedding only post-VIBLOK will be subtracted. A number above 0 indicates a decreased detection rate after VIBLOK. With an 8% anticipated asymptomatic shedding rate, 80% power, 50 subjects taking samples for 28 days are needed to show a 50% reduction.||||0.248
70886921|NCT03080961|141259859|SUPERIORITY|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
70886922|NCT02908529|141259875|SUPERIORITY||Median Difference (Final Values)|-15.9|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70886923|NCT03337724|141259880|SUPERIORITY||Stratified Hazard Ratio|1.02||||0.9237|TWO_SIDED|95.0|0.71|1.45|||Log Rank||Stratification variables were: prior adjuvant/neoadjuvant chemotherapy (yes vs. no), region, tumor PIK3CA/AKT1/PTEN alteration status (PIK3CA/AKT1-activating mutations vs. PTEN alterations with no PIK3CA/AKT1-activating mutations).|||1.45|0.71|0.9237
70886924|NCT03337724|141259881|SUPERIORITY||Stratified Hazard Ratio|1.0||||0.9965|TWO_SIDED|95.0|0.71|1.4|||Log Rank||Stratification variables were: prior adjuvant/neoadjuvant chemotherapy (yes vs. no), region, prior therapy with a PI3K or mTOR inhibitor (yes vs. no).|||1.40|0.71|0.9965
70886925|NCT03337724|141259889|SUPERIORITY||Stratified Hazard Ratio|1.08|||||TWO_SIDED|95.0|0.73|1.58|||||Stratification was done prior adjuvant/neoadjuvant chemotherapy (yes vs. no), region, tumor PIK3CA/AKT1/PTEN alteration status (PIK3CA/AKT1-activating mutations vs. PTEN alterations with no PIK3CA/AKT1-activating mutations).|||1.58|0.73|
70886926|NCT03337724|141259889|SUPERIORITY||Stratified Hazard Ratio|0.94|||||TWO_SIDED|95.0|0.65|1.37|||||Stratification variables were: prior adjuvant/neoadjuvant chemotherapy (yes vs. no), region, prior therapy with a PI3K or mTOR inhibitor (yes vs. no).|||1.37|0.65|
70886927|NCT03337724|141259892|SUPERIORITY||Hazard Ratio (HR)|1.36||||0.2162|TWO_SIDED|95.0|0.83|2.22|||Log Rank||Stratification variables were: prior adjuvant/neoadjuvant chemotherapy (yes vs. no), region, prior therapy with a PI3K or mTOR inhibitor (yes vs. no).||Stratified Analysis|2.22|0.83|0.2162
70886928|NCT03551210|141259903|NON_INFERIORITY|The non-inferiority bound was designated at the level of -15%|Difference in percentage|6.1|||||TWO_SIDED|95.0|-0.7|13.0||||||||13.0|-0.7|
70886929|NCT03551210|141259903|OTHER||Odds Ratio (OR)|1.45|||=|0.499|TWO_SIDED|95.0|0.49|4.29|||Regression, Logistic|||||4.29|0.49|=0.499
70886930|NCT03551210|141259904|OTHER||Difference in percentage|4.3|||=|0.08|TWO_SIDED|95.0|-0.6|9.7|||Barnard's test|||Visit 2||9.7|-0.6|=0.08
70886931|NCT03551210|141259904|OTHER||Difference in percentage|3.7|||=|0.246|TWO_SIDED|95.0|-2.0|9.8|||Barnard's test|||Visit 3||9.8|-2.0|=0.246
70886932|NCT03551210|141259905|OTHER||||||=|0.154|||||||Barnard test|||||||=0.154
70886933|NCT03551210|141259906|OTHER||||||=|0.14|||||||Log Rank|||||||=0.14
70886934|NCT03551210|141259907|OTHER||||||=|0.26|||||||Barnard test|||||||=0.26
70886935|NCT03551210|141259908|OTHER||||||=|0.14||||||Visit 2 assessment|Barnard's test|||||||=0.14
70886936|NCT03551210|141259908|OTHER|||||||0.515||||||Visit 3 assessment|Barnard's test|||||||0.515
70886937|NCT03551210|141259908|OTHER|||||||0.515||||||Visit 4 assessment|Barnard's test|||||||0.515
70886938|NCT02239536|141259923|OTHER|||||||0.05|||||||Chi-squared|||||||0.05
70886939|NCT02239536|141259924|OTHER|||||||0.05|||||||Chi-squared|||||||0.05
70886940|NCT02239536|141259924|OTHER|||||||0.001|||||||Chi-squared|||||||0.001
70886941|NCT00368940|141259943|SUPERIORITY||Cohen D at week 12|0.6||||0.005|TWO_SIDED|95.0|0.13|1.06|||Mixed Models Analysis|||||1.06|0.13|0.005
70886942|NCT00368940|141259944|SUPERIORITY||Cohen D at week 12|0.67||||0.001|TWO_SIDED|95.0|0.2|1.14|||Mixed Models Analysis|||||1.14|0.20|0.001
70886943|NCT00368940|141259945|SUPERIORITY|||||||0.0268|||||||Wilcoxon (Mann-Whitney)|||||||0.0268
70886944|NCT00368940|141259946|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
70886945|NCT02896127|141259989|SUPERIORITY||Odds Ratio (OR)|2.47|||<|0.0001|TWO_SIDED|95.0|1.65|3.69|||Regression, Logistic||||"PTFU=post-treatment follow-up (12 weeks after last study treatment)~95% confidence intervals are from a score method with continuity correction."|3.69|1.65|<.0001
70886946|NCT00739336|141259997|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||Piecewise linear multilevel models with multiple observations nested within each participant were used. Random components (intercept, slope) were introduced into the model to account for dependence among measurements within a participant and assessed by nested model comparisons using the deviance statistic (difference in -2LL).||||<0.01
70886947|NCT02477020|141260011|SUPERIORITY_OR_OTHER||Least square mean difference|-5.46|STANDARD_ERROR_OF_MEAN|3.442||0.115|TWO_SIDED|95.0|-12.26|1.35||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using MMRM|MMRM||TAK-063 - Placebo. Baseline Positive and Negative Symptom Scale (PANSS) total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|||1.35|-12.26|0.115
70886948|NCT02477020|141260012|SUPERIORITY_OR_OTHER||Least square mean difference|-0.79|STANDARD_ERROR_OF_MEAN|1.508||0.602|TWO_SIDED|95.0|-3.77|2.19||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using MMRM.|MMRM||TAK-063 - Placebo. Baseline PANSS total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|Change at Week 1||2.19|-3.77|0.602
70886949|NCT02477020|141260012|SUPERIORITY_OR_OTHER||Least square mean difference|-2.22|STANDARD_ERROR_OF_MEAN|2.229||0.322|TWO_SIDED|95.0|-6.62|2.19||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline PANSS total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|Change at Week 2||2.19|-6.62|0.322
70886950|NCT02477020|141260012|SUPERIORITY_OR_OTHER||Least square mean difference|-3.46|STANDARD_ERROR_OF_MEAN|2.813||0.221|TWO_SIDED|95.0|-9.02|2.1||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline PANSS total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|Change at Week 3||2.10|-9.02|0.221
70886951|NCT02477020|141260012|SUPERIORITY_OR_OTHER||Least square mean difference|-2.11|STANDARD_ERROR_OF_MEAN|3.147||0.504|TWO_SIDED|95.0|-8.33|4.11||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline PANSS total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|Change at Week 4||4.11|-8.33|0.504
70886952|NCT02477020|141260012|SUPERIORITY_OR_OTHER||Least square mean difference|-3.91|STANDARD_ERROR_OF_MEAN|3.231||0.229|TWO_SIDED|95.0|-10.3|2.48||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline PANSS total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|Change at Week 5||2.48|-10.30|0.229
70886953|NCT02477020|141260013|SUPERIORITY_OR_OTHER||Least square mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.562||0.195|TWO_SIDED|95.0|-1.84|0.38||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 1||0.38|-1.84|0.195
70886954|NCT02477020|141260013|SUPERIORITY_OR_OTHER||Least square mean difference|-1.19|STANDARD_ERROR_OF_MEAN|0.786||0.132|TWO_SIDED|95.0|-2.74|0.36||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 2||0.36|-2.74|0.132
70886955|NCT02477020|141260013|SUPERIORITY_OR_OTHER||Least square mean difference|-1.94|STANDARD_ERROR_OF_MEAN|0.959||0.045|TWO_SIDED|95.0|-3.84|-0.05||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 3||-0.05|-3.84|0.045
70886956|NCT02477020|141260013|SUPERIORITY_OR_OTHER||Least square mean difference|-1.54|STANDARD_ERROR_OF_MEAN|1.025||0.135|TWO_SIDED|95.0|-3.56|0.49||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 4||0.49|-3.56|0.135
70886957|NCT02477020|141260013|SUPERIORITY_OR_OTHER||Least square mean difference|-2.01|STANDARD_ERROR_OF_MEAN|1.09||0.067|TWO_SIDED|95.0|-4.17|0.14||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 5||0.14|-4.17|0.067
70886958|NCT02477020|141260013|SUPERIORITY_OR_OTHER||Least square mean difference|-1.9|STANDARD_ERROR_OF_MEAN|1.119||0.092|TWO_SIDED|95.0|-4.11|0.31||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 6||0.31|-4.11|0.092
70886959|NCT02477020|141260013|SUPERIORITY_OR_OTHER||Least square mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.566||0.548|TWO_SIDED|95.0|-0.78|1.46||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 1||1.46|-0.78|0.548
70886960|NCT02477020|141260013|SUPERIORITY_OR_OTHER||Least square mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.756||0.42|TWO_SIDED|95.0|-2.11|0.88||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 2||0.88|-2.11|0.420
70886961|NCT02477020|141260013|SUPERIORITY_OR_OTHER||Least square mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.818||0.857|TWO_SIDED|95.0|-1.47|1.76||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 3||1.76|-1.47|0.857
70886962|NCT02477020|141260013|SUPERIORITY_OR_OTHER||Least square mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.936||0.527|TWO_SIDED|95.0|-2.44|1.26||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 4||1.26|-2.44|0.527
70886963|NCT02477020|141260013|SUPERIORITY_OR_OTHER||Least square mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.94||0.875|TWO_SIDED|95.0|-2.01|1.71||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 5||1.71|-2.01|0.875
70886964|NCT02477020|141260013|SUPERIORITY_OR_OTHER||Least square mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.94||0.441|TWO_SIDED|95.0|-2.58|1.13||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 6||1.13|-2.58|0.441
70886965|NCT02477020|141260013|SUPERIORITY_OR_OTHER||Least square mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.406||0.362|TWO_SIDED|95.0|-1.17|0.43||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 1||0.43|-1.17|0.362
70886966|NCT02477020|141260013|SUPERIORITY_OR_OTHER||Least square mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.53||0.687|TWO_SIDED|95.0|-1.26|0.83||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 2||0.83|-1.26|0.687
70886967|NCT02477020|141260013|SUPERIORITY_OR_OTHER||Least square mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.618||0.458|TWO_SIDED|95.0|-1.68|0.76||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 3||0.76|-1.68|0.458
70886968|NCT02477020|141260013|SUPERIORITY_OR_OTHER||Least square mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.704||0.991|TWO_SIDED|95.0|-1.38|1.4||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 4||1.40|-1.38|0.991
70886969|NCT02477020|141260013|SUPERIORITY_OR_OTHER||Least square mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.782||0.354|TWO_SIDED|95.0|-2.27|0.82||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 5||0.82|-2.27|0.354
70886970|NCT02477020|141260013|SUPERIORITY_OR_OTHER||Least square mean difference|-1.26|STANDARD_ERROR_OF_MEAN|0.804||0.119|TWO_SIDED|95.0|-2.85|0.33||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 6||0.33|-2.85|0.119
70886971|NCT02477020|141260013|SUPERIORITY_OR_OTHER||Least square mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.469||0.493|TWO_SIDED|95.0|-1.25|0.6||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 1||0.60|-1.25|0.493
70886972|NCT02477020|141260013|SUPERIORITY_OR_OTHER||Least square mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.504||0.949|TWO_SIDED|95.0|-0.96|1.03||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 2||1.03|-0.96|0.949
70886973|NCT02477020|141260013|SUPERIORITY_OR_OTHER||Least square mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.604||0.153|TWO_SIDED|95.0|-2.06|0.33||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 3||0.33|-2.06|0.153
70886974|NCT02477020|141260013|SUPERIORITY_OR_OTHER||Least square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.681||0.994|TWO_SIDED|95.0|-1.34|1.35||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 4||1.35|-1.34|0.994
70886975|NCT02477020|141260013|SUPERIORITY_OR_OTHER||Least square mean difference|-0.62|STANDARD_ERROR_OF_MEAN|0.679||0.365|TWO_SIDED|95.0|-1.96|0.73||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 5||0.73|-1.96|0.365
70886976|NCT02477020|141260013|SUPERIORITY_OR_OTHER||Least square mean difference|-1.12|STANDARD_ERROR_OF_MEAN|0.653||0.088|TWO_SIDED|95.0|-2.41|0.17||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 6||0.17|-2.41|0.088
70886977|NCT02477020|141260013|SUPERIORITY_OR_OTHER||Least square mean difference|0.25|STANDARD_ERROR_OF_MEAN|0.397||0.535|TWO_SIDED|95.0|-0.54|1.03||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 1||1.03|-0.54|0.535
70886978|NCT02477020|141260013|SUPERIORITY_OR_OTHER||Least square mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.502||0.412|TWO_SIDED|95.0|-1.4|0.58||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 2||0.58|-1.40|0.412
70886979|NCT02477020|141260013|SUPERIORITY_OR_OTHER||Least square mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.522||0.354|TWO_SIDED|95.0|-1.52|0.55||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 3||0.55|-1.52|0.354
70886980|NCT02477020|141260013|SUPERIORITY_OR_OTHER||Least square mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.59||0.589|TWO_SIDED|95.0|-1.49|0.85||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 4||0.85|-1.49|0.589
70886981|NCT02477020|141260013|SUPERIORITY_OR_OTHER||Least square mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.569||0.36|TWO_SIDED|95.0|-1.65|0.6||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 5||0.60|-1.65|0.360
70886982|NCT02477020|141260013|SUPERIORITY_OR_OTHER||Least square mean difference|-0.68|STANDARD_ERROR_OF_MEAN|0.635||0.288|TWO_SIDED|95.0|-1.93|0.58||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 6||0.58|-1.93|0.288
70886983|NCT02477020|141260014|SUPERIORITY_OR_OTHER||Least square mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.59||0.238|TWO_SIDED|95.0|-1.87|0.47||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 1||0.47|-1.87|0.238
70886984|NCT02477020|141260014|SUPERIORITY_OR_OTHER||Least square mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.784||0.359|TWO_SIDED|95.0|-2.27|0.83||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 2||0.83|-2.27|0.359
70886985|NCT02477020|141260014|SUPERIORITY_OR_OTHER||Least square mean difference|-1.48|STANDARD_ERROR_OF_MEAN|0.943||0.119|TWO_SIDED|95.0|-3.34|0.38||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 3||0.38|-3.34|0.119
70886986|NCT02477020|141260014|SUPERIORITY_OR_OTHER||Least square mean difference|-1.2|STANDARD_ERROR_OF_MEAN|1.014||0.238|TWO_SIDED|95.0|-3.21|0.8||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 4||0.80|-3.21|0.238
70886987|NCT02477020|141260014|SUPERIORITY_OR_OTHER||Least square mean difference|-1.73|STANDARD_ERROR_OF_MEAN|1.051||0.102|TWO_SIDED|95.0|-3.81|0.35||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 5||0.35|-3.81|0.102
70886988|NCT02477020|141260014|SUPERIORITY_OR_OTHER||Least square mean difference|-1.6|STANDARD_ERROR_OF_MEAN|1.094||0.145|TWO_SIDED|95.0|-3.77|0.56||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 6||0.56|-3.77|0.145
70886989|NCT02477020|141260014|SUPERIORITY_OR_OTHER||Least square mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.504||0.902|TWO_SIDED|95.0|-0.93|1.06||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 1||1.06|-0.93|0.902
70886990|NCT02477020|141260014|SUPERIORITY_OR_OTHER||MMRM|-0.59|STANDARD_ERROR_OF_MEAN|0.693||0.396|TWO_SIDED|95.0|-1.96|0.78||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 2||0.78|-1.96|0.396
70886991|NCT02477020|141260014|SUPERIORITY_OR_OTHER||Least square mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.722||0.612|TWO_SIDED|95.0|-1.79|1.06||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 3||1.06|-1.79|0.612
70886992|NCT02477020|141260014|SUPERIORITY_OR_OTHER||Least square mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.856||0.67|TWO_SIDED|95.0|-2.06|1.33||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 4||1.33|-2.06|0.670
70886993|NCT02477020|141260014|SUPERIORITY_OR_OTHER||Least square mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.892||0.807|TWO_SIDED|95.0|-1.98|1.55||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 5||1.55|-1.98|0.807
70886994|NCT02477020|141260014|SUPERIORITY_OR_OTHER||Least square mean difference|-1.14|STANDARD_ERROR_OF_MEAN|0.853||0.182|TWO_SIDED|95.0|-2.83|0.54||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 6||0.54|-2.83|0.182
70886995|NCT02477020|141260014|SUPERIORITY_OR_OTHER||Least square mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.801||0.933|TWO_SIDED|95.0|-1.52|1.65||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 1||1.65|-1.52|0.933
70886996|NCT02477020|141260014|SUPERIORITY_OR_OTHER||Least square mean difference|-0.61|STANDARD_ERROR_OF_MEAN|1.151||0.596|TWO_SIDED|95.0|-2.89|1.66||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 2||1.66|-2.89|0.596
70886997|NCT02477020|141260014|SUPERIORITY_OR_OTHER||Least square mean difference|-1.31|STANDARD_ERROR_OF_MEAN|1.455||0.371|TWO_SIDED|95.0|-4.18|1.57||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 3||1.57|-4.18|0.371
70886998|NCT02477020|141260014|SUPERIORITY_OR_OTHER||Least square mean difference|-0.37|STANDARD_ERROR_OF_MEAN|1.625||0.821|TWO_SIDED|95.0|-3.58|2.84||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 4||2.84|-3.58|0.821
70886999|NCT02477020|141260014|SUPERIORITY_OR_OTHER||Least square mean difference|-1.61|STANDARD_ERROR_OF_MEAN|1.621||0.323|TWO_SIDED|95.0|-4.81|1.6||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 5||1.60|-4.81|0.323
70887000|NCT02477020|141260014|SUPERIORITY_OR_OTHER||Least square mean difference|-2.44|STANDARD_ERROR_OF_MEAN|1.732||0.161|TWO_SIDED|95.0|-5.87|0.98||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 6||0.98|-5.87|0.161
70887001|NCT02477020|141260015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.664||||0.017|TWO_SIDED|95.0|1.263|10.624|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 1||10.624|1.263|0.017
70887002|NCT02477020|141260015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.782||||0.009|TWO_SIDED|95.0|1.287|6.014|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 2||6.014|1.287|0.009
70887003|NCT02477020|141260015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.818||||0.108|TWO_SIDED|95.0|0.877|3.771|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 3||3.771|0.877|0.108
70887004|NCT02477020|141260015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.222||||0.596|TWO_SIDED|95.0|0.583|2.561|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 4||2.561|0.583|0.596
70887005|NCT02477020|141260015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.542||||0.263|TWO_SIDED|95.0|0.722|3.292|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 5||3.292|0.722|0.263
70887006|NCT02477020|141260015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.567||||0.253||95.0|0.725|3.388|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 6||3.388|0.725|0.253
70887007|NCT02477020|141260016|SUPERIORITY_OR_OTHER||Least square mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.095||0.619|TWO_SIDED|95.0|-0.23|0.14||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 1||0.14|-0.23|0.619
70887008|NCT02477020|141260016|SUPERIORITY_OR_OTHER||Least square mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.136||0.116|TWO_SIDED|95.0|-0.48|0.05||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 2||0.05|-0.48|0.116
70887009|NCT02477020|141260016|SUPERIORITY_OR_OTHER||Least square mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.166||0.009|TWO_SIDED|95.0|-0.77|-0.11||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 3||-0.11|-0.77|0.009
70887010|NCT02477020|141260016|SUPERIORITY_OR_OTHER||Least square mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.18||0.049|TWO_SIDED|95.0|-0.72|0.0||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 4||0.00|-0.72|0.049
70887011|NCT02477020|141260016|SUPERIORITY_OR_OTHER||Least square mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.191||0.016|TWO_SIDED|95.0|-0.85|-0.09||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 5||-0.09|-0.85|0.016
70887012|NCT02477020|141260016|SUPERIORITY_OR_OTHER||Least square mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.202||0.035||95.0|-0.83|-0.03||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 6||-0.03|-0.83|0.035
70887013|NCT02477020|141260017|SUPERIORITY_OR_OTHER||Least square mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.128||0.746|TWO_SIDED|95.0|-0.29|0.21||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 1||0.21|-0.29|0.746
70887014|NCT02477020|141260017|SUPERIORITY_OR_OTHER||Least mean square difference|-0.37|STANDARD_ERROR_OF_MEAN|0.173||0.034|TWO_SIDED|95.0|-0.72|-0.03||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 2||-0.03|-0.72|0.034
70887015|NCT02477020|141260017|SUPERIORITY_OR_OTHER||Least square mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.203||0.006|TWO_SIDED|95.0|-0.97|-0.17||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 3||-0.17|-0.97|0.006
70887016|NCT02477020|141260017|SUPERIORITY_OR_OTHER||Least square mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.22||0.013|TWO_SIDED|95.0|-0.99|-0.12||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 4||-0.12|-0.99|0.013
70887017|NCT02477020|141260017|SUPERIORITY_OR_OTHER||Least mean square difference|-0.56|STANDARD_ERROR_OF_MEAN|0.238||0.02|TWO_SIDED|95.0|-1.03|-0.09||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 5||-0.09|-1.03|0.020
70887018|NCT02477020|141260017|SUPERIORITY_OR_OTHER||Least square mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.244||0.007|TWO_SIDED|95.0|-1.15|-0.18||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 6||-0.18|-1.15|0.007
70887019|NCT02477020|141260018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.726||||0.077|TWO_SIDED|95.0|0.899|8.267||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 1||8.267|0.899|0.077
70887020|NCT02477020|141260018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.331||||0.036|TWO_SIDED|95.0|1.055|5.153||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 2||5.153|1.055|0.036
70887021|NCT02477020|141260018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.69||||0.015|TWO_SIDED|95.0|1.208|5.99||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 3||5.990|1.208|0.015
70887022|NCT02477020|141260018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.737||||0.158|TWO_SIDED|95.0|0.807|3.735||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 4||3.735|0.807|0.158
70887023|NCT02477020|141260018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.739||||0.164|TWO_SIDED|95.0|0.798|3.789||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 5||3.789|0.798|0.164
70887024|NCT02477020|141260018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.44||||0.003|TWO_SIDED|95.0|1.523|7.77||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 6||7.770|1.523|0.003
70887025|NCT02477020|141260019|SUPERIORITY_OR_OTHER||Least square mean difference|1.8|STANDARD_ERROR_OF_MEAN|1.547||0.246|TWO_SIDED|95.0|-1.26|4.86||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline BACS total score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline BACS total score-by-week interaction.|Change at Week 3||4.86|-1.26|0.246
70887026|NCT02477020|141260019|SUPERIORITY_OR_OTHER||Least square mean difference|2.2|STANDARD_ERROR_OF_MEAN|1.767||0.216|TWO_SIDED|95.0|-1.3|5.69||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|Least square mean difference||TAK-063 - Placebo. Baseline BACS total score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline BACS total score-by-week interaction|Change at Week 6||5.69|-1.30|0.216
70887027|NCT02477020|141260020|SUPERIORITY_OR_OTHER||Least mean square difference|-0.38|STANDARD_ERROR_OF_MEAN|1.664||0.82|TWO_SIDED|95.0|-3.67|2.91||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline BNSS total score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline BNSS total score-by-week interaction.|Change at Week 3||2.91|-3.67|0.820
70887028|NCT02477020|141260020|SUPERIORITY_OR_OTHER||Least square mean difference|-2.87|STANDARD_ERROR_OF_MEAN|2.05||0.163|TWO_SIDED|95.0|-6.93|1.18||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline BNSS total score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline BACS total score-by-week interaction.|Change at Week 6||1.18|-6.93|0.163
70887029|NCT02477020|141260021|SUPERIORITY_OR_OTHER||Least square mean difference|2.69|STANDARD_ERROR_OF_MEAN|1.769||0.131|TWO_SIDED|95.0|-0.81|6.19||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline PSP score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PSP score-by-week interaction.|Change at Week 3||6.19|-0.81|0.131
70887030|NCT02477020|141260021|SUPERIORITY_OR_OTHER||Least square mean difference|2.62|STANDARD_ERROR_OF_MEAN|2.313||0.26|TWO_SIDED|95.0|-1.96|7.19||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline PSP score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PSP score-by-week interaction.|Change at Week 6||7.19|-1.96|0.260
70887031|NCT02477020|141260022|SUPERIORITY_OR_OTHER||Least square mean difference|0.06|STANDARD_ERROR_OF_MEAN|1.855||0.973|TWO_SIDED|95.0|-3.61|3.73||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline UPSA-B composite score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline UPSA-B composite score-by-week interaction.|Change at Week 3||3.73|-3.61|0.973
70887032|NCT02477020|141260022|SUPERIORITY_OR_OTHER||Least mean square difference|-0.54|STANDARD_ERROR_OF_MEAN|2.255||0.812|TWO_SIDED|95.0|-5.0|3.92||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline UPSA-B composite score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline UPSA-B composite score-by-week interaction.|Change at Week 6||3.92|-5.00|0.812
70887033|NCT00120042|141260041|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||We planned that up to 300 women would be recruited. This sample size would achieve 80% poer at a 5% significance level to detect a reduction from 40% placental retention rate with no specific therapy (Group 1) to 20% with Group 2 or 3. An interim analysis was planned after 240 women had been recruited.||||0.05
70887034|NCT00120042|141260042|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
70887035|NCT02099721|141260044|EQUIVALENCE|The equivalence margin is a hazard ratio significantly above 0.70.|Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.38|0.57|||||The hazard ratio, estimated by a Cox proportional hazard model, has time to first treated VT/VF for 1.5 Prevention in the numerator, with Secondary Prevention in the denominator.|"H0: Hazard ratio of Implanted 1.5 patients (Group C) to implanted secondary patients (Group A) ≤ 0.70~HA: Hazard ratio of Implanted 1.5 patients (Group C) to implanted secondary patients (Group A) \> 0.70"||0.57|0.38|
70887036|NCT02099721|141260045|SUPERIORITY|A hazard ratio significantly below 1 indicates reduced mortality in the 1.5 implanted group.|Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.4|0.66||The p-value is for the effect of treatment group on time to death, adjusting for the baseline covariates of age, gender, QRS duration, ischemic cardiomyopathy, LBBB, NYHA classification, diabetes, LVEF, syncope, NSVT and PVCs.|Wald chi-square||Multiple imputations were employed to account for missing baseline covariates.|The null hypothesis is that the hazard ratio of implanted to non-implanted 1.5 patients = 1. The alternative is that the ratio is not equal to 1.||0.66|0.40|< 0.0001
70887037|NCT01126541|141260047|NON_INFERIORITY_OR_EQUIVALENCE|Primary objective to demonstrate noninferiority of retreatment with one 1000 mg rituximab infusion. Mean ±SD of the DAS28-CRP AUC at 24 months = 2218 ±967 (based on EDWARDS, REFLEX and DANCER study data). H0 (null hypothesis): Arm B - Arm A \>20%. H1: Arm B - Arm A ≤ 20%. Power = 80%; Larger difference clinically acceptable = 20% = 444; Significance level of 2.5% (one-sided).||||||0.465|||||||Wilcoxon (Mann-Whitney)|||Change from Day 1 to Week 24 (initial treatment)||||0.465
70887038|NCT01126541|141260047|NON_INFERIORITY_OR_EQUIVALENCE|Primary objective to demonstrate noninferiority of retreatment with one 1000 mg rituximab infusion. Mean ±SD of the DAS28-CRP AUC at 24 months = 2218 ±967 (based on EDWARDS, REFLEX and DANCER study data). H0 (null hypothesis): Arm B - Arm A \>20%. H1: Arm B - Arm A ≤ 20%. Power = 80%; Larger difference clinically acceptable = 20% = 444; Significance level of 2.5% (one-sided)||||||0.161|||||||Wilcoxon (Mann-Whitney)|||Arm A vs. Arm B: Change from 1st retreatment to 24 weeks after||||0.161
70887039|NCT01126541|141260047|NON_INFERIORITY_OR_EQUIVALENCE|Primary objective to demonstrate noninferiority of retreatment with one 1000 mg rituximab infusion. Mean ±SD of the DAS28-CRP AUC at 24 months = 2218 ±967 (based on EDWARDS, REFLEX and DANCER study data). H0 (null hypothesis): Arm B - Arm A \>20%. H1: Arm B - Arm A ≤ 20%. Power = 80%; Larger difference clinically acceptable = 20% = 444; Significance level of 2.5% (one-sided)||||||0.524|||||||Student t-test|||Arm A vs. Arm B: Change from 2nd retreatment to 24 weeks after||||0.524
70887040|NCT01126541|141260048|NON_INFERIORITY_OR_EQUIVALENCE|Primary objective to demonstrate noninferiority of retreatment with one 1000 mg rituximab infusion. Mean plus or minus (±)SD of the DAS28-CRP AUC at 24 months = 2218 ±967 (based on EDWARDS, REFLEX and DANCER study data). H0 (null hypothesis): Arm B - Arm A \>20%. H1: Arm B - Arm A ≤ 20%. Power = 80%; Larger difference clinically acceptable = 20% = 444; Significance level of 2.5% (one-sided)|Adjusted difference|51.38|STANDARD_DEVIATION|92.0|||TWO_SIDED|95.0|-131.22|233.98|||||Covariate analysis with baseline DAS28-CRP value as covariate|||233.98|-131.22|
70887041|NCT01126541|141260068|SUPERIORITY_OR_OTHER|||||||0.389|||||||Wilcoxon (Mann-Whitney)|||Day 1 to Week 104||||0.389
70887042|NCT01126541|141260068|SUPERIORITY_OR_OTHER|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||1st retreatment to Week 104||||0.374
70887043|NCT01126541|141260068|SUPERIORITY_OR_OTHER|||||||0.277|||||||Wilcoxon (Mann-Whitney)|||Weel 24 to Week 104||||0.277
70887044|NCT01126541|141260069|SUPERIORITY_OR_OTHER|||||||0.278|||||||Wilcoxon (Mann-Whitney)|||Total cortisone: Week 24 to Week 104||||0.278
70887045|NCT01126541|141260069|SUPERIORITY_OR_OTHER|||||||0.887|||||||Wilcoxon (Mann-Whitney)|||Oral cortisone: Week 24 to Week 104||||0.887
70887046|NCT01126541|141260069|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||IV cortisone: Week 24 to Week 104||||<0.001
70887047|NCT01420302|141260097|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
70887048|NCT05446909|141260110|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||>0.05
70887049|NCT05446909|141260111|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||>0.05
70887050|NCT05446909|141260112|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||>0.05
70887051|NCT05446909|141260113|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
70887052|NCT05446909|141260114|SUPERIORITY|||||||0.754|||||||ANOVA|||||||0.754
70887053|NCT05446909|141260115|SUPERIORITY|||||||0.985|||||||ANOVA|||||||0.985
70887054|NCT05446909|141260116|SUPERIORITY|||||||0.877|||||||ANOVA|||||||0.877
70887055|NCT00086580|141260144|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61|||<|0.001|TWO_SIDED|95.0|0.467|0.795|||Regression, Cox|Cox proportional hazards model was stratified by Rai Stage Group||||0.795|0.467|<0.001
70887056|NCT00086580|141260145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.178|TWO_SIDED|95.0|-0.03|0.15||P-value presented is adjusted for multiple tests using Hochberg procedure for 3 clinically important secondary endpoints: ORR, CR rates and OS.|Cochran-Mantel-Haenszel|CMH chi-square test for a difference in overall response rates between treatments stratified by Rai Stage Group.|Difference and confidence interval (CI) calculated using the recommended method by Altman et al.|Comparison of Overall Response.||0.15|-0.03|0.178
70887057|NCT00086580|141260145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.018|TWO_SIDED|95.0|0.02|0.15||P-value presented is adjusted for multiple tests using Hochberg procedure for 3 clinically important secondary endpoints: ORR, CR rates and OS.|Cochran-Mantel-Haenszel|CMH chi-square test for a difference in complete response rates between treatments stratified by Rai Stage Group.|Difference and confidence interval (CI) calculated using the recommended method by Altman et al.|Comparison of complete response (CR).||0.15|0.02|0.018
70887058|NCT00086580|141260146|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.648||||0.042|TWO_SIDED|95.0|0.449|0.937||P-value presented is adjusted for multiple tests using Hochberg procedure for 3 clinically important secondary endpoints: ORR, CR rates and OS.|Regression, Cox|Cox proportional hazards model stratified by Rai Stage Group||||0.937|0.449|0.042
70887059|NCT00086580|141260147|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.562|||<|0.001|TWO_SIDED|95.0|0.42|0.752|||Regression, Cox|Cox regression model stratified by Rai Stage Group.||||0.752|0.420|<0.001
70887060|NCT00086580|141260149|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.718||||0.021|TWO_SIDED|95.0|0.543|0.951|||Regression, Cox|Cox proportional hazards model stratified by Rai Stage Group.||||0.951|0.543|0.021
70887061|NCT00086580|141260157|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.75||||0.102|TWO_SIDED|95.0|0.531|1.059|||Regression, Cox|||||1.059|0.531|0.102
70887062|NCT00086580|141260158|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.443|||<|0.001|TWO_SIDED|95.0|0.292|0.671|||Regression, Cox|||||0.671|0.292|<0.001
70887063|NCT00086580|141260159|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.066||||0.819|TWO_SIDED|95.0|0.619|1.836|||Regression, Cox|Cox proportional hazards model||||1.836|0.619|0.819
70887064|NCT00086580|141260160|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.416|||<|0.001|TWO_SIDED|95.0|0.25|0.69|||Regression, Cox|Cox proportional hazards model||||0.690|0.250|<0.001
70887065|NCT00086580|141260163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.014|TWO_SIDED|95.0|0.01|0.08|||Cochran-Mantel-Haenszel|CMH chi-square test for a difference in response rates between treatments stratified by Rai Stage Group.||||0.08|0.01|0.014
70887066|NCT00261716|141260164|SUPERIORITY_OR_OTHER|||||||0.33|||||||Chi-squared|1 degree of freedom||Intent to treat analysis||||.33
70887067|NCT00261716|141260165|SUPERIORITY_OR_OTHER|||||||0.75|||||||t-test, 2 sided|degrees of freedom=36||intent to treat analysis||||.75
70887068|NCT00261716|141260166|SUPERIORITY_OR_OTHER|||||||0.41|||||||t-test, 2 sided|degrees of freedom=17||||||.41
70887069|NCT00261716|141260167|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|Fishers exact= 1.0; one degree of freedom||intent to treat --all participants who obtained at least one job||||>.05
70887070|NCT00261716|141260167|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||||||>.05
70887071|NCT00261716|141260168|SUPERIORITY_OR_OTHER|||||||0.37|||||||Mixed Models Analysis|employment status effect- F(1,12)=..85||Intent to treat analysis||||.37
70887072|NCT00261716|141260168|SUPERIORITY_OR_OTHER|||||||0.16|||||||Mixed Models Analysis|time effect F(1,54)=.2.05||||||.16
70887073|NCT00261716|141260168|SUPERIORITY_OR_OTHER|||||||0.63|||||||Mixed Models Analysis|employment status X time effect F (1,54)=.. 24||||||.63
70887074|NCT00261716|141260169|SUPERIORITY_OR_OTHER|||||||0.62|||||||Mixed Models Analysis|employment status effect F(1,12)=.26||intent to treat analysis||||.62
70887075|NCT00261716|141260169|SUPERIORITY_OR_OTHER|||||||0.65|||||||Mixed Models Analysis|time effect F (1,58)=.21 ,.||||||.65
70887076|NCT00261716|141260169|SUPERIORITY_OR_OTHER|||||||0.81|||||||Mixed Models Analysis|employment status X time effect F(1,58)=.06||||||.81
70887077|NCT00261716|141260170|SUPERIORITY_OR_OTHER|||||||0.19|||||||Mixed Models Analysis|employment status effect F(1,12)=1.95,||Intent to treat analysis||||.19
70887078|NCT00261716|141260170|SUPERIORITY_OR_OTHER|||||||0.09|||||||Mixed Models Analysis|time effect (1.54)=2.99,||||||.09
70887079|NCT00261716|141260170|SUPERIORITY_OR_OTHER|||||||0.39|||||||Mixed Models Analysis|employment status X time effect (F(1,54)=.74||||||.39
70887080|NCT00673452|141260176|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) Model: PGI-S = baseline PGI-S + treatment + pooled investigator + visit + treatment-by-visit + baseline-by-visit.||Patients treated with 60-120 mg duloxetine for 12 weeks compared with placebo will show greater improvement in symptoms as assessed by Patient's Global Impressions of Improvement (PGI-I). Sample size determined using 2-sided t-test with significance level of 0.05, and discontinuation rate of 5% without postbaseline data. With 261 patients per arm, study has approximately 85% power to detect treatment group difference of -0.4 points (standard deviation of 1.5) in PGI-I between treatment groups.||||<0.001
70887081|NCT00673452|141260177|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-1.19|-0.31||P-value for Worst Pain Severity. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.31|-1.19|<0.001
70887082|NCT00673452|141260177|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.61||||0.001|TWO_SIDED|95.0|-0.99|-0.24||P-value for Least Pain Severity. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.24|-0.99|0.001
70887083|NCT00673452|141260177|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.74|||<|0.001|TWO_SIDED|95.0|-1.13|-0.35||P-value for Average Pain Severity. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.35|-1.13|<0.001
70887084|NCT00673452|141260177|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.76|||<|0.001|TWO_SIDED|95.0|-1.2|-0.31||P-value for Pain Right Now Severity. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.31|-1.20|<0.001
70887085|NCT00673452|141260177|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.94|||<|0.001|TWO_SIDED|95.0|-1.39|-0.49||P-value for General Activity Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.49|-1.39|<0.001
70887086|NCT00673452|141260177|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.95|||<|0.001|TWO_SIDED|95.0|-1.41|-0.49||P-value for Mood Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.49|-1.41|<0.001
70887087|NCT00673452|141260177|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.8|||<|0.001|TWO_SIDED|95.0|-1.24|-0.36||P-value for Walking Ability Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.36|-1.24|<0.001
70887088|NCT00673452|141260177|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.76|||<|0.001|TWO_SIDED|95.0|-1.21|-0.32||P-value for Normal Work Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.32|-1.21|<0.001
70887089|NCT00673452|141260177|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.95|||<|0.001|TWO_SIDED|95.0|-1.38|-0.52||P-value for Relations with Other People Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.52|-1.38|<0.001
70887090|NCT00673452|141260177|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.87|||<|0.001|TWO_SIDED|95.0|-1.35|-0.39||P-value for Sleep Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.39|-1.35|<0.001
70887091|NCT00673452|141260177|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.39|||<|0.001|TWO_SIDED|95.0|-1.92|-0.86||P-value for Enjoyment of Life Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.86|-1.92|<0.001
70887092|NCT00673452|141260177|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.93|||<|0.001|TWO_SIDED|95.0|-1.33|-0.52||P-value for Average Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.52|-1.33|<0.001
70887093|NCT00673452|141260178|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.83||||0.005|TWO_SIDED|95.0|-1.41|-0.25||P-value for General Fatigue. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|ANCOVA|Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.25|-1.41|0.005
70887094|NCT00673452|141260178|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.72||||0.013|TWO_SIDED|95.0|-1.3|-0.15||P-value for Physical Fatigue. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|ANCOVA|Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.15|-1.30|0.013
70887095|NCT00673452|141260178|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.92||||0.003|TWO_SIDED|95.0|-1.52|-0.32||P-value for Mental Fatigue. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|ANCOVA|Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.32|-1.52|0.003
70887096|NCT00673452|141260178|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.88||||0.005|TWO_SIDED|95.0|-1.49|-0.26||P-value for Reduced Activity. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|ANCOVA|Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.26|-1.49|0.005
70887097|NCT00673452|141260178|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.94|||<|0.001|TWO_SIDED|95.0|-1.49|-0.38||P-value for Reduced Motivation. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|ANCOVA|Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.38|-1.49|<0.001
70887098|NCT00673452|141260179|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.89||||0.007|TWO_SIDED|95.0|-3.25|-0.53||The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BDI-II Total score change from baseline to endpoint = baseline BDI-II total score + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.53|-3.25|0.007
70887099|NCT00673452|141260180|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.34|||<|0.001|TWO_SIDED|95.0|-0.51|-0.16||The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: CGI-S score change from baseline at endpoint = CGI-S score baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.16|-0.51|<0.001
70887100|NCT00673452|141260181|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.07||||0.907|TWO_SIDED|95.0|-1.13|1.27||The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BAI total score change from baseline to endpoint = baseline BAI total + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||1.27|-1.13|0.907
70887101|NCT00673452|141260182|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.22||||0.003|TWO_SIDED|95.0|1.76|8.67||P-value for Bodily Pain. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||8.67|1.76|0.003
70887102|NCT00673452|141260182|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.42|||<|0.001|TWO_SIDED|95.0|3.41|9.43||P-value for General Health. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||9.43|3.41|<0.001
70887103|NCT00673452|141260182|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|7.44|||<|0.001|TWO_SIDED|95.0|4.41|10.47||P-value for Mental Health. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||10.47|4.41|<0.001
70887104|NCT00673452|141260182|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.47||||0.002|TWO_SIDED|95.0|2.06|8.88||P-value for Physical Functioning. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||8.88|2.06|0.002
70887105|NCT00673452|141260182|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|9.78||||0.004|TWO_SIDED|95.0|3.11|16.45||P-value for Role-Emotional. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||16.45|3.11|0.004
70887106|NCT00673452|141260182|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.59||||0.632|TWO_SIDED|95.0|-4.93|8.11||P-value for Role-Physical. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||8.11|-4.93|0.632
70887107|NCT00673452|141260182|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.67|||<|0.001|TWO_SIDED|95.0|2.73|10.61||P-value for Social Functioning. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||10.61|2.73|<0.001
70887108|NCT00673452|141260182|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.31||||0.015|TWO_SIDED|95.0|0.84|7.79||P-value for Vitality. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||7.79|0.84|0.015
70887109|NCT00673452|141260182|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.14||||0.134|TWO_SIDED|95.0|-0.35|2.64||P-value for Physical Component Summary (PCS). The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||2.64|-0.35|0.134
70887110|NCT00673452|141260182|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.83|||<|0.001|TWO_SIDED|95.0|2.05|5.6||P-value for Mental Component Summary (MCS). The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||5.60|2.05|<0.001
70887111|NCT00673452|141260183|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.96||||0.083|TWO_SIDED|95.0|-2.05|0.13||A priori threshold for statistical significance is 0.05.|ANCOVA|Model: MGH-CPFQ change from baseline at endpoint = MGH-CPFQ baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||0.13|-2.05|0.083
70887112|NCT00673452|141260184|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-1.18|-0.32||P-value for Mood. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.32|-1.18|<0.001
70887113|NCT00673452|141260184|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.64||||0.003|TWO_SIDED|95.0|-1.05|-0.22||P-value for Anxiety. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.22|-1.05|0.003
70887114|NCT00673452|141260184|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.72||||0.003|TWO_SIDED|95.0|-1.19|-0.25||P-value for Pain. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.25|-1.19|0.003
70887115|NCT00673452|141260184|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.49||||0.05|TWO_SIDED|95.0|-0.97|0.0||P-value for Sleep. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.00|-0.97|0.050
70887116|NCT00673452|141260184|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.87|||<|0.001|TWO_SIDED|95.0|-1.32|-0.43||P-value for Stiffness. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.43|-1.32|<0.001
70887117|NCT00673452|141260185|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||A priori threshold for statistical significance is 0.05.|Fisher Exact|||||||0.002
70887118|NCT00673452|141260186|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||A priori threshold for statistical significance is 0.05.|Fisher Exact|||||||0.003
70887119|NCT00673452|141260187|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.82||||0.084|TWO_SIDED|95.0|-0.25|3.88||P-value for Systolic Blood Pressure (SBP). A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Change = baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||3.88|-0.25|0.084
70887120|NCT00673452|141260187|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.52||||0.434|TWO_SIDED|95.0|-0.79|1.84||P-value for Diastolic Blood Pressure (DBP). A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Change = baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||1.84|-0.79|0.434
70887121|NCT00673452|141260188|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.96||||0.003|TWO_SIDED|95.0|0.67|3.26||A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Change = baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||3.26|0.67|0.003
70887122|NCT00673452|141260189|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for Suicidal Ideation. A priori threshold for statistical significance is 0.05.|Fisher Exact|||||||1.00
70887123|NCT00673452|141260190|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.83|||<|0.001|TWO_SIDED|95.0|-1.21|-0.45||A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Change = baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.45|-1.21|<0.001
70887124|NCT00079274|141260195|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.15|TWO_SIDED|95.0|0.92|1.68|||Regression, Cox|HR and p-value reported from a multivariate Cox PH regression model, adjusted for number of nodes, histologic grade, and T stage.||||1.68|0.92|0.15
70887125|NCT00079274|141260196|SUPERIORITY||Hazard Ratio (HR)|1.27||||0.25|TWO_SIDED|95.0|0.85|1.92|||Regression, Cox|HR and p-value reported from a multivariate Cox PH regression model, adjusted for number of nodes, histologic grade, and T stage.||||1.92|0.85|0.25
70887126|NCT00079274|141260197|SUPERIORITY||||||<|0.001|||||||Chi-squared|two-sided chi-squared test||||||<0.001
70887127|NCT00079274|141260198|SUPERIORITY||||||<|0.001|||||||Chi-squared|Two-sided chi-squared test||||||<0.001
70887128|NCT03969212|141260230|SUPERIORITY||Adjusted OR (BMX vs Placebo)|0.68|||=|0.013|TWO_SIDED|95.38|0.5|0.93|||GEE|||The odds ratio (OR) shown represents the odds of Baloxavir Marboxil (BMX) versus the odds of Placebo.||0.93|0.50|= 0.013
70887129|NCT03969212|141260231|SUPERIORITY||Adjusted OR (BMX vs Placebo)|0.75|||=|0.155|TWO_SIDED|95.38|0.5|1.12|||GEE model|||The OR shown represents the odds of BMX versus the odds of Placebo.||1.12|0.50|= 0.1550
70887130|NCT03969212|141260232|OTHER||Odds Ratio (BMX vs Placebo}]|0.76|||||TWO_SIDED|95.38|0.55|1.06||||||The OR shown represents the odds of BMX versus the odds of Placebo.||1.06|0.55|
70887131|NCT03969212|141260233|OTHER||Odds Ratio (BMX vs Placebo)|0.69|||||TWO_SIDED|95.38|0.46|1.04||||||The OR shown represents the odds of BMX versus the odds of Placebo.||1.04|0.46|
70887132|NCT03969212|141260234|OTHER||Adjusted OR (BMX vs Placebo)|0.66|||||TWO_SIDED|95.38|0.48|0.91|||GEE model|||The OR shown represents the odds of BMX versus the odds of Placebo.||0.91|0.48|
70887133|NCT03969212|141260235|OTHER||Adjusted OR (BMX vs Placebo)|0.73|||||TWO_SIDED|95.38|0.48|1.09|||Two-Sided P-value|||The OR shown represents the odds of BMX versus the odds of Placebo.||1.09|0.48|
70887134|NCT03969212|141260236|OTHER||Adjusted OR (BMX vs Placebo)|0.71|||||TWO_SIDED|95.38|0.53|0.94|||Two-Sided P-value|||The OR shown represents the odds of BMX versus the odds of Placebo.||0.94|0.53|
70887135|NCT03969212|141260237|OTHER||Odds Ratio (BMX vs Placebo)|0.79|||||TWO_SIDED|95.38|0.59|1.06||||||The OR shown represents the odds of BMX versus the odds of Placebo.||1.06|0.59|
70887136|NCT03969212|141260238|OTHER||Adjusted OR (BMX vs Placebo)|0.72|||||TWO_SIDED|95.38|0.49|1.07|||Two-Sided P-value|||The OR shown represents the odds of BMX versus the odds of Placebo.||1.07|0.49|
70887137|NCT03969212|141260239|OTHER||Odds Ratio (BMX vs Placebo)|0.71|||||TWO_SIDED|95.38|0.48|1.04||||||The OR shown represents the odds of BMX versus the odds of Placebo.||1.04|0.48|
70887138|NCT01147653|141260248|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.72|TWO_SIDED|95.0|-2.6|3.7|||t-test, 2 sided|||H0: The true mean 1-year change in GMFM-66 is the same on Autologous Umbilical Cord Blood and Placebo||3.7|-2.6|0.72
70887139|NCT01147653|141260249|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
70887140|NCT01147653|141260250|SUPERIORITY|||||||0.473|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Behavior change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.473
70887141|NCT01147653|141260250|SUPERIORITY|||||||0.377|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Bodily Pain/Discomfort change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.377
70887142|NCT01147653|141260250|SUPERIORITY|||||||0.844|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Family Cohesion change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.844
70887143|NCT01147653|141260250|SUPERIORITY|||||||0.322|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month General Behavior change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.322
70887144|NCT01147653|141260250|SUPERIORITY|||||||0.927|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month General Health Perceptions change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.927
70887145|NCT01147653|141260250|SUPERIORITY|||||||0.199|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Global Behavior change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.199
70887146|NCT01147653|141260250|SUPERIORITY|||||||0.294|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Growth and Development change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.294
70887147|NCT01147653|141260250|SUPERIORITY|||||||0.726|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Overall Health change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.726
70887148|NCT01147653|141260250|SUPERIORITY|||||||0.315|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Parental Impact-Emotional change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.315
70887149|NCT01147653|141260250|SUPERIORITY|||||||0.396|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Parental Impact-Time change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.396
70887150|NCT01147653|141260250|SUPERIORITY|||||||0.381|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Physical Abilities change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.381
70887151|NCT01147653|141260250|SUPERIORITY|||||||0.869|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Temperament and Moods change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.869
70887152|NCT01147653|141260251|SUPERIORITY|||||||0.055|||||||Wilcoxon (Mann-Whitney)|||H0: The 12 month Access to Services change score is identically distributed in patients assigned Autologous Cord Blood Reinfusion First and Placebo First.||||0.055
70887153|NCT01147653|141260251|SUPERIORITY|||||||0.121|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month 2 Emotional Well Being and Self Esteem change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.121
70887154|NCT01147653|141260251|SUPERIORITY|||||||0.647|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month 2 Family Health change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.647
70887155|NCT01147653|141260251|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Functioning change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.170
70887156|NCT01147653|141260251|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Pain and Impact of Disability change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.410
70887157|NCT01147653|141260251|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Participation and Physical Health change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.200
70887158|NCT01147653|141260251|SUPERIORITY|||||||0.225|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Social wellbeing and acceptance change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.225
70887159|NCT01147653|141260254|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||||||0.290
70887160|NCT01147653|141260257|SUPERIORITY|||||||0.697|||||||t-test, 2 sided|||||||0.697
70887161|NCT01147653|141260258|SUPERIORITY|||||||0.912|||||||t-test, 2 sided|||||||0.912
70887162|NCT01147653|141260259|SUPERIORITY|||||||0.544|||||||t-test, 2 sided|||||||0.544
70887163|NCT01147653|141260260|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
70887164|NCT01147653|141260261|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||||||0.76
70887165|NCT01147653|141260262|SUPERIORITY|||||||0.176|||||||Wilcoxon (Mann-Whitney)|||||||0.176
70887166|NCT01147653|141260263|SUPERIORITY|||||||0.099|||||||t-test, 2 sided|||||||0.099
70887167|NCT01147653|141260264|SUPERIORITY|||||||0.131|||||||Wilcoxon (Mann-Whitney)|||||||0.131
70887168|NCT01147653|141260265|SUPERIORITY|||||||0.478|||||||t-test, 2 sided|||||||0.478
70887169|NCT01147653|141260266|SUPERIORITY|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||||||0.029
70887170|NCT01147653|141260267|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||||||0.310
70887171|NCT01147653|141260269|SUPERIORITY|||||||0.233|||||||Wilcoxon (Mann-Whitney)|||H0: The population distribution of Modified Ashworth Scale scores is the same at 1-year post-infusion with autologous cord blood and placebo.||||0.233
70887172|NCT01147653|141260273|SUPERIORITY|||||||0.762|||||||Wilcoxon (Mann-Whitney)|||||||0.762
70887173|NCT01147653|141260274|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||H0: The population distribution of the 1-year GMFM-66 change score is the same for patients infused with Low and High doses of autologous umbilical cord blood.||||0.05
70887174|NCT01147653|141260274|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||H0: The population distribution of the 1-year GMFM-66 change score is the same for patients infused with High doses of autologous umbilical cord blood and Placebo.||||0.15
70887175|NCT01147653|141260274|SUPERIORITY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||H0: The population distribution of the 1-year GMFM-66 change score is the same for patients infused with Low doses of autologous umbilical cord blood and placebo.||||0.21
70887176|NCT01147653|141260275|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||H0: The population distribution of differences between observed and expected GMFM-66 change scores at 1-year post-infusion is the same for patients receiving Low and High doses of autologous umbilical cord blood.||||<0.01
70887177|NCT01147653|141260276|SUPERIORITY|H0: The population distribution of the Peabody Gross Motor Quotient change score 1 year post-infusion with autologous umbilical cord blood is the same in patients receiving a Low infused dose and a High infused dose.||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
70887178|NCT01147653|141260277|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.04|TWO_SIDED|95.0|0.01|0.38|||Wilcoxon (Mann-Whitney)|||H0: The true mean 1-year change in normalized whole brain connectivity is the same in patients infused with Low and High doses of autologous umbilical cord blood.||0.38|0.01|0.04
70887179|NCT02144675|141260302|OTHER||||||<|0.05|||||||Regression, Cox|||||||<.05
70887180|NCT01813019|141260303|SUPERIORITY_OR_OTHER|||||||0.671|||||||Mixed Models Analysis|||||||0.671
70887181|NCT01458171|141260340|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||0.45||||||||0.450||
70887182|NCT01458171|141260340|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||0.523||||||||0.523||
70887183|NCT00094653|141260401|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0004|TWO_SIDED|95.0|0.55|0.85|||Stratified Log Rank||Cox model for Hazard ratios (HR) and log-rank test p-values were stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||0.85|0.55|0.0004
70887184|NCT00094653|141260402|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.0026|TWO_SIDED|95.0|0.51|0.87|||Stratified Log Rank||Cox model for Hazard ratios (HR) and log-rank test p-values were stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||0.87|0.51|0.0026
70887185|NCT00094653|141260402|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.7575|TWO_SIDED|95.0|0.83|1.3|||Stratified Log Rank||Cox model for Hazard ratios (HR) and log-rank test p-values were stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||1.30|0.83|0.7575
70887186|NCT00094653|141260404|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.66|1.0|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||1.00|0.66|
70887187|NCT00094653|141260404|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.5|0.83|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||0.83|0.50|
70887188|NCT00094653|141260404|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25|||||TWO_SIDED|95.0|1.01|1.53|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||1.53|1.01|
70887189|NCT00094653|141260406|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.66|1.0|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||1.00|0.66|
70887190|NCT00094653|141260406|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.5|0.83|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||0.83|0.50|
70887191|NCT00094653|141260406|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25|||||TWO_SIDED|95.0|1.01|1.53|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||1.53|1.01|
70887192|NCT00094653|141260408|SUPERIORITY_OR_OTHER|||||||0.0433||95.0||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel|||||||0.0433
70887193|NCT00094653|141260408|SUPERIORITY_OR_OTHER|||||||0.0012||95.0||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel|||||||0.0012
70887194|NCT00094653|141260408|SUPERIORITY_OR_OTHER|||||||0.0402||95.0||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel|||||||0.0402
70887195|NCT00094653|141260411|SUPERIORITY_OR_OTHER|||||||0.0179||95.0||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel|||||||0.0179
70887196|NCT00094653|141260411|SUPERIORITY_OR_OTHER|||||||0.0002||95.0||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel|||||||0.0002
70887197|NCT00094653|141260411|SUPERIORITY_OR_OTHER|||||||0.0429||95.0||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel|||||||0.0429
70887198|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||0.2805|TWO_SIDED|95.0|-2.5|8.6|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Global quality of life change from baseline||8.6|-2.5|0.2805
70887199|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.63|TWO_SIDED|95.0|-5.0|8.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Global quality of life change from baseline||8.2|-5.0|0.6300
70887200|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.6026|TWO_SIDED|95.0|-3.9|6.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Global quality of life change from baseline||6.8|-3.9|0.6026
70887201|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9||||0.1219|TWO_SIDED|95.0|-1.1|8.9|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Physical change from baseline||8.9|-1.1|0.1219
70887202|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0||||0.0978|TWO_SIDED|95.0|-0.9|11.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Physical change from baseline||11.0|-0.9|0.0978
70887203|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.659|TWO_SIDED|95.0|-6.0|3.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Physical change from baseline||3.8|-6.0|0.6590
70887204|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3||||0.248|TWO_SIDED|95.0|-3.0|11.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Role change, change from baseline||11.7|-3.0|0.2480
70887205|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2||||0.4742|TWO_SIDED|95.0|-5.6|12.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Role change, change from baseline||12.0|-5.6|0.4742
70887206|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.7597|TWO_SIDED|95.0|-6.1|8.3|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Role change, change from baseline||8.3|-6.1|0.7597
70887207|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.9119|TWO_SIDED|95.0|-4.7|5.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Cognitive change from baseline||5.2|-4.7|0.9119
70887208|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.7616|TWO_SIDED|95.0|-6.9|5.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Cognitive change from baseline||5.0|-6.9|0.7616
70887209|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.6266|TWO_SIDED|95.0|-3.6|6.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Cognitive change from baseline||6.0|-3.6|0.6266
70887210|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9984|TWO_SIDED|95.0|-4.8|4.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Emotional change from baseline||4.8|-4.8|0.9984
70887211|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.4873|TWO_SIDED|95.0|-7.8|3.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Emotional change from baseline||3.7|-7.8|0.4873
70887212|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.3938|TWO_SIDED|95.0|-2.7|6.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Emotional change from baseline||6.7|-2.7|0.3938
70887213|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.6695|TWO_SIDED|95.0|-8.1|5.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Social change from baseline||5.2|-8.1|0.6695
70887214|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.4041|TWO_SIDED|95.0|-11.3|4.6|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Social change from baseline||4.6|-11.3|0.4041
70887215|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9||||0.5538|TWO_SIDED|95.0|-4.5|8.3|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Social change from baseline||8.3|-4.5|0.5538
70887216|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9||||0.2259|TWO_SIDED|95.0|-10.3|2.4|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Fatigue change from baseline||2.4|-10.3|0.2259
70887217|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.6168|TWO_SIDED|95.0|-9.6|5.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Fatigue change from baseline||5.7|-9.6|0.6168
70887218|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.5329|TWO_SIDED|95.0|-8.2|4.3|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Fatigue change from baseline||4.3|-8.2|0.5329
70887219|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.9397|TWO_SIDED|95.0|-4.7|5.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Nausea and Vomiting change from baseline||5.0|-4.7|0.9397
70887220|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.6716|TWO_SIDED|95.0|-7.1|4.6|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Nausea and Vomiting change from baseline||4.6|-7.1|0.6716
70887221|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.5497|TWO_SIDED|95.0|-3.3|6.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Nausea and Vomiting change from baseline||6.2|-3.3|0.5497
70887222|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3||||0.0625|TWO_SIDED|95.0|-12.8|0.3|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Pain change from baseline||0.3|-12.8|0.0625
70887223|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.3214|TWO_SIDED|95.0|-11.9|3.9|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Pain change from baseline||3.9|-11.9|0.3214
70887224|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.4898|TWO_SIDED|95.0|-8.7|4.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Pain change from baseline||4.2|-8.7|0.4898
70887225|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6||||0.0761|TWO_SIDED|95.0|-11.8|0.6|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Dyspnea change from baseline||0.6|-11.8|0.0761
70887226|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8||||0.3187|TWO_SIDED|95.0|-11.2|3.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Dyspnea change from baseline||3.7|-11.2|0.3187
70887227|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.5548|TWO_SIDED|95.0|-7.9|4.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Dyspnea change from baseline||4.2|-7.9|0.5548
70887228|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5||||0.245|TWO_SIDED|95.0|-12.1|3.1|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Sleep disturbance change from baseline||3.1|-12.1|0.2450
70887229|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.8464|TWO_SIDED|95.0|-10.0|8.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Sleep disturbance change from baseline||8.2|-10.0|0.8464
70887230|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.3351|TWO_SIDED|95.0|-10.9|3.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Sleep Disturbance change from baseline||3.7|-10.9|0.3351
70887231|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.6291|TWO_SIDED|95.0|-9.1|5.5|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Appetite loss change from baseline||5.5|-9.1|0.6291
70887232|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.7675|TWO_SIDED|95.0|-7.4|10.1|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Appetite Loss change from baseline||10.1|-7.4|0.7675
70887233|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1||||0.3911|TWO_SIDED|95.0|-10.2|4.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Appetite Loss change from baseline||4.0|-10.2|0.3911
70887234|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5||||0.0431|TWO_SIDED|95.0|-12.9|-0.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Constipation change from baseline||-0.2|-12.9|0.0431
70887235|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.9||||0.0101|TWO_SIDED|95.0|-17.4|-2.4|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Constipation change from baseline||-2.4|-17.4|0.0101
70887236|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4||||0.2796|TWO_SIDED|95.0|-2.8|9.5|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Constipation change from baseline||9.5|-2.8|0.2796
70887237|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3||||0.194|TWO_SIDED|95.0|-2.2|10.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Diarrhea change from baseline||10.8|-2.2|0.1940
70887238|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.9||||0.0821|TWO_SIDED|95.0|-0.9|14.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Diarrhea change from baseline||14.8|-0.9|0.0821
70887239|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.4169|TWO_SIDED|95.0|-9.0|3.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Diarrhea change from baseline||3.8|-9.0|0.4169
70887240|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.5717|TWO_SIDED|95.0|-7.5|4.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Financial Impact change from baseline||4.2|-7.5|0.5717
70887241|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.6949|TWO_SIDED|95.0|-5.6|8.4|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Financial Impact change from baseline||8.4|-5.6|0.6949
70887242|NCT00094653|141260413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1||||0.2849|TWO_SIDED|95.0|-8.8|2.6|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Financial Impact change from baseline||2.6|-8.8|0.2849
70887243|NCT00330551|141260472|SUPERIORITY||t-test|0.77|||=|0.05|TWO_SIDED|95.0|0.483|1.058|||t-test, 2 sided||||t(80)=5.3, p\<.001|1.058|0.483|=.05
70887244|NCT00330551|141260473|SUPERIORITY||Risk Difference (RD)|11.1|||=|0.001|TWO_SIDED||||||Chi-squared|||||||=.001
70887245|NCT00330551|141260474|SUPERIORITY||||||=|0.83|||||||Chi-squared|||||||=.83
70887246|NCT00330551|141260475|SUPERIORITY||||||=|0.2|||||||ANOVA|||A priori hypothesis was that long-acting injectible risperidone would lead to greater duration of work/school attendance than oral risperidone.||||=.20
70887247|NCT00330551|141260476|SUPERIORITY|||||||0.71|||||||ANOVA|||||||.71
70887248|NCT00330551|141260477|SUPERIORITY||||||=|0.57|||||||ANOVA|||||||=.57
70887249|NCT00330551|141260479|SUPERIORITY||||||<|0.16|||||||ANOVA|||||||<.16
70887250|NCT00330551|141260480|SUPERIORITY||||||=|0.41|||||||ANOVA|||||||=.41
70887251|NCT03120013|141260481|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
70887252|NCT03120013|141260482|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
70887253|NCT03120013|141260483|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
70887254|NCT03120013|141260484|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
70887255|NCT03120013|141260485|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
70887256|NCT03120013|141260486|SUPERIORITY||||||=|0.006|||||||ANCOVA|||||||=0.006
70887257|NCT03120013|141260487|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
70887258|NCT03120013|141260488|SUPERIORITY||||||=|0.043|||||||ANCOVA|||||||=0.043
70887259|NCT01339390|141260545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3941|STANDARD_ERROR_OF_MEAN|0.5759||0.4937|TWO_SIDED|95.0|-0.7347|1.5229||calculated after fitting the data to a repeated measures mixed model to control for repeated subject and random site and group effects|t-test, 2 sided|accounted for repeated measures and random effects|The difference is expressed as the Move (arm 2) group minus the Move Out (arm 1) group|This is the analysis at 12 months, comparing the change in weight from 12 months to baseline in our Move Out (arm 1) vs Move (arm 2) groups||1.5229|-.7347|0.4937
70887260|NCT01339390|141260545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5893|STANDARD_ERROR_OF_MEAN|0.5759||0.3062|TWO_SIDED|95.0|-0.5395|1.7181||calculated after fitting the data to a repeated measures mixed model to control for repeated subject and random site and group effects|t-test, 2 sided|accounted for repeated measures and random effects|The difference is expressed as the Move (arm 2) group minus the Move Out (arm 1) group|This is the analysis at 24 months, comparing the change in weight from 24 months to baseline in our Move Out (arm 1) vs Move (arm 2) groups||1.7181|-0.5395|0.3062
70887261|NCT04847674|141260546|OTHER||LS mean difference|-0.027||||0.7914|TWO_SIDED|95.0|-0.2276|0.174|||Mixed Models Analysis|||Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1740|-0.2276|0.7914
70887262|NCT04847674|141260546|OTHER||LS mean difference|-0.011||||0.9115|TWO_SIDED|95.0|-0.2126|0.19|||Mixed Models Analysis|||Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1900|-0.2126|0.9115
70887263|NCT04847674|141260548|OTHER||LS mean difference|0.026||||0.6001|TWO_SIDED|95.0|-0.0733|0.1261|||Mixed Models Analysis||Change from baseline in FEV1 over 12 weeks: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1261|-0.0733|0.6001
70887264|NCT04847674|141260548|OTHER||LS mean difference|0.027||||0.5922|TWO_SIDED|95.0|-0.0732|0.1276|||Mixed Models Analysis||Change from baseline in FEV1 over 12 weeks: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1276|-0.0732|0.5922
70887265|NCT04847674|141260548|OTHER||LS mean difference|0.027||||0.6017|TWO_SIDED|95.0|-0.0744|0.1277|||Mixed Models Analysis||Change from baseline in FEV1 over 16 weeks: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1277|-0.0744|0.6017
70887266|NCT04847674|141260548|OTHER||LS mean difference|0.022||||0.6664|TWO_SIDED|95.0|-0.0796|0.1239|||Mixed Models Analysis||Change from baseline in FEV1 over 16 weeks: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1239|-0.0796|0.6664
70887267|NCT04847674|141260549|OTHER||Hodges-Lehmann (HL) estimator|0.4||||0.7261|TWO_SIDED|95.0|-2.33|3.31|||Wilcoxon (Mann-Whitney)||Change from baseline in weekly average of rescue medication use over 12 weeks: TEV-53275 Dose A versus Placebo|Analysis was performed using Wilcoxon rank-sum test stratified on randomization stratification factors.||3.31|-2.33|0.7261
70887268|NCT04847674|141260549|OTHER||HL estimator|-0.5||||0.765|TWO_SIDED|95.0|-3.56|3.32|||Wilcoxon (Mann-Whitney)||Change from baseline in weekly average of rescue medication use over 12 weeks: TEV-53275 Dose B versus Placebo|Analysis was performed using Wilcoxon rank-sum test stratified on randomization stratification factors.||3.32|-3.56|0.7650
70887269|NCT04847674|141260549|OTHER||HL estimator|0.2||||0.7942|TWO_SIDED|95.0|-2.44|3.04|||Wilcoxon (Mann-Whitney)||Change from baseline in weekly average of rescue medication use over 16 weeks: TEV-53275 Dose A versus Placebo|Analysis was performed using Wilcoxon rank-sum test stratified on randomization stratification factors.||3.04|-2.44|0.7942
70887270|NCT04847674|141260549|OTHER||HL estimator|-0.8||||0.6147|TWO_SIDED|95.0|-3.81|2.55|||Wilcoxon (Mann-Whitney)||Change from baseline in weekly average of rescue medication use over 16 weeks: TEV-53275 Dose B versus Placebo|Analysis was performed using Wilcoxon rank-sum test stratified on randomization stratification factors.||2.55|-3.81|0.6147
70887271|NCT04847674|141260551|OTHER||LS mean difference|-0.083||||0.4394|TWO_SIDED|95.0|-0.2971|0.1301|||Mixed Models Analysis|||Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1301|-0.2971|0.4394
70887272|NCT04847674|141260551|OTHER||LS mean difference|-0.089||||0.4051|TWO_SIDED|95.0|-0.302|0.1231|||Mixed Models Analysis|||Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1231|-0.3020|0.4051
70887273|NCT04847674|141260554|OTHER||LS mean difference|0.093||||0.3485|TWO_SIDED|95.0|-0.1031|0.2893|||Mixed Models Analysis||Change from baseline in FEF25-75 over 12 weeks: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEF25-75 as a covariate.||0.2893|-0.1031|0.3485
70887274|NCT04847674|141260554|OTHER||LS mean difference|0.033||||0.7432|TWO_SIDED|95.0|-0.1644|0.2296|||Mixed Models Analysis||Change from baseline in FEF25-75 over 12 weeks: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEF25-75 as a covariate.||0.2296|-0.1644|0.7432
70887275|NCT04847674|141260554|OTHER||LS mean difference|0.087||||0.4014|TWO_SIDED|95.0|-0.118|0.292|||Mixed Models Analysis||Change from baseline in FEF25-75 over 16 weeks: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEF25-75 as a covariate.||0.2920|-0.1180|0.4014
70887276|NCT04847674|141260554|OTHER||LS mean difference|0.01||||0.9259|TWO_SIDED|95.0|-0.196|0.2153|||Mixed Models Analysis||Change from baseline in FEF25-75 over 16 weeks: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEF25-75 as a covariate.||0.2153|-0.1960|0.9259
70887277|NCT04847674|141260556|OTHER||LS mean difference|0.0||||0.9829|TWO_SIDED|95.0|-0.43|0.42|||Mixed Models Analysis||Change from baseline in ACQ-6 at Week 12: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACQ-6 as a covariate.||0.42|-0.43|0.9829
70887278|NCT04847674|141260556|OTHER||LS mean difference|0.1||||0.6302|TWO_SIDED|95.0|-0.32|0.52|||Mixed Models Analysis||Change from baseline in ACQ-6 at Week 12: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACQ-6 as a covariate.||0.52|-0.32|0.6302
70887279|NCT04847674|141260556|OTHER||LS mean difference|-0.1||||0.6707|TWO_SIDED|95.0|-0.54|0.35|||Mixed Models Analysis||Change from baseline in ACQ-6 at Week 16: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACQ-6 as a covariate.||0.35|-0.54|0.6707
70887280|NCT04847674|141260556|OTHER||LS mean difference|0.0||||0.994|TWO_SIDED|95.0|-0.44|0.43|||Mixed Models Analysis||Change from baseline in ACQ-6 at Week 16: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACQ-6 as a covariate.||0.43|-0.44|0.9940
70887281|NCT04847674|141260557|OTHER||LS mean difference|-0.7||||0.4683|TWO_SIDED|95.0|-2.71|1.26|||Mixed Models Analysis||Change from baseline in ACT at Week 12: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACT as a covariate.||1.26|-2.71|0.4683
70887282|NCT04847674|141260557|OTHER||LS mean difference|-1.2||||0.2239|TWO_SIDED|95.0|-3.16|0.75|||Mixed Models Analysis||Change from baseline in ACT at Week 12: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACT as a covariate.||0.75|-3.16|0.2239
70887283|NCT04847674|141260557|OTHER||LS mean difference|-0.6||||0.5389|TWO_SIDED|95.0|-2.51|1.32|||Mixed Models Analysis||Change from baseline in ACT at Week 16: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACT as a covariate.||1.32|-2.51|0.5389
70887284|NCT04847674|141260557|OTHER||LS mean difference|-0.9||||0.3564|TWO_SIDED|95.0|-2.75|1.0|||Mixed Models Analysis||Change from baseline in ACT at Week 16: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACT as a covariate.||1.00|-2.75|0.3564
70887285|NCT04847674|141260558|OTHER||LS mean difference|-0.2||||0.4436|TWO_SIDED|95.0|-0.62|0.27|||Mixed Models Analysis||Change from baseline in AQLQT at Week 12: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline AQLQ as a covariate.||0.27|-0.62|0.4436
70887286|NCT04847674|141260558|OTHER||LS mean difference|-0.1||||0.597|TWO_SIDED|95.0|-0.56|0.32|||Mixed Models Analysis||Change from baseline in AQLQT at Week 12: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline AQLQ as a covariate.||0.32|-0.56|0.5970
70887287|NCT04847674|141260558|OTHER||LS mean difference|-0.2||||0.3769|TWO_SIDED|95.0|-0.68|0.26|||Mixed Models Analysis||Change from baseline in AQLQT at Week 16: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline AQLQ as a covariate.||0.26|-0.68|0.3769
70887288|NCT04847674|141260558|OTHER||LS mean difference|-0.2||||0.4595|TWO_SIDED|95.0|-0.64|0.29|||Mixed Models Analysis||Change from baseline in AQLQT at Week 16: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline AQLQ as a covariate.||0.29|-0.64|0.4595
70887289|NCT01462357|141260607|NON_INFERIORITY|Non-inferiority with respect to seroconversion was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the difference (Gardasil 2 dose Group minus Cervarix 2 dose Group) was below 5%.|Difference in SCR|0.0|||||TWO_SIDED|95.0|-1.16|1.15||||||Immune response to anti-HPV-16 in terms of seroconversion rates (SCR): To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.||1.15|-1.16|
70887290|NCT01462357|141260607|NON_INFERIORITY|Non-inferiority with respect to seroconversion was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the difference (Gardasil 2 dose Group minus Cervarix 2 dose Group) was below 5%.|Difference in SCR|0.0|||||TWO_SIDED|95.0|-1.15|1.14||||||Immune response to anti-HPV-18 in terms of SCR: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.||1.14|-1.15|
70887291|NCT01462357|141260608|NON_INFERIORITY|Non-inferiority with respect to GMT was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% CI for the GMT ratio (Gardasil 2 dose Group divided by Cervarix 2 dose Group) was below 2.|GMT ratio|0.61|||||TWO_SIDED|95.0|0.54|0.69|||ANOVA|||Immune response to anti-HPV-16 in terms of Geometric Mean Titers (GMT): To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.||0.69|0.54|
70887292|NCT01462357|141260608|NON_INFERIORITY|Non-inferiority with respect to GMT was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the GMT ratio (Gardasil 2 dose Group divided by Cervarix 2 dose Group) was below 2.|GMT ratio|0.23|||||TWO_SIDED|95.0|0.2|0.26|||ANOVA|||Immune response to anti-HPV-18 in terms of GMT: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.||0.26|0.20|
70887293|NCT01462357|141260609|SUPERIORITY|Superiority was shown if the lower limit of the 95% CI for the ratio of GMTs (Cervarix 2 dose Group divided by Gardasil 2 dose Group) was above 1 for anti-HPV-18 antibodies.|GMT ratio|4.52||||0.0001|TWO_SIDED|95.0|3.97|5.13|||ANOVA|||Anti-HPV-18 immune response: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is superior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, in 9-14 year-old females, 1 month after the last dose (Month 7) regardless of serostatus.||5.13|3.97|0.0001
70887294|NCT01462357|141260609|SUPERIORITY|Superiority was shown if the lower limit of the 95% CI for the ratio of GMTs (Cervarix 2 dose Group divided by Gardasil 2 dose Group) was above 1 for anti-HPV-16 antibodies.|GMT ratio|1.69||||0.0001|TWO_SIDED|95.0|1.49|1.91|||ANOVA|||Anti-HPV-16 immune response: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is superior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, in 9-14 year-old females, 1 month after the last dose (Month 7) regardless of serostatus.||1.91|1.49|0.0001
70887295|NCT01387607|141260638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.1906||0.0001|TWO_SIDED|95.0|-1.1|-0.36||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||-0.36|-1.10|0.0001
70887296|NCT01387607|141260639|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.4376||||0.1397|TWO_SIDED|95.0|0.8732|2.3667||Based on the combined categories from Cochran-Mantel-Haenszel test adjusted for pooled center.|Cochran-Mantel-Haenszel||Overall odds ratio was calculated based on Mentel-Haenszel method as pregabalin versus placebo.|Statistical analysis performed for PGIC endpoint re-categorized into much/very much improved and other.||2.3667|0.8732|0.1397
70887297|NCT01387607|141260639|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.4626||||0.151|TWO_SIDED|95.0|0.8596|2.4886||Based on the combined categories from Cochran-Mantel-Haenszel test adjusted for pooled center.|Cochran-Mantel-Haenszel||Overall odds ratio was calculated based on Mentel-Haenszel method as pregabalin versus placebo.|Statistical analysis performed for PGIC endpoint re-categorized into any improvement (participants who were very much improved or much improved or minimally improved) and other.||2.4886|0.8596|0.1510
70887298|NCT01387607|141260640|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.99|STANDARD_ERROR_OF_MEAN|1.6804||0.0762|TWO_SIDED|95.0|-6.3|0.32||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||0.32|-6.30|0.0762
70887299|NCT01387607|141260641|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.8924||||0.0044|TWO_SIDED|95.0|1.2007|2.9827||From Cochran-Mantel-Haenszel test comparing pregabalin to placebo adjusted for pooled center.|Cochran-Mantel-Haenszel||Overall odds ratio was calculated based on Mantel-Haenszel method as pregabalin versus placebo.|||2.9827|1.2007|0.0044
70887300|NCT01387607|141260642|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9683||||0.0189|TWO_SIDED|95.0|1.1151|3.4742||From Cochran-Mantel-Haenszel test comparing pregabalin to placebo adjusted for pooled center.|Cochran-Mantel-Haenszel||Overall odds ratio was calculated based on Mantel-Haenszel method as pregabalin versus placebo.|||3.4742|1.1151|0.0189
70887301|NCT01387607|141260643|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.427|STANDARD_ERROR_OF_MEAN|2.0152||0.09|TWO_SIDED|95.0|-7.39|0.54||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||||0.54|-7.39|0.0900
70887302|NCT01387607|141260644|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.527|STANDARD_ERROR_OF_MEAN|2.1858||0.2485|TWO_SIDED|95.0|-1.77|6.83||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||Statistical analysis for snoring.||6.83|-1.77|0.2485
70887303|NCT01387607|141260644|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.355|STANDARD_ERROR_OF_MEAN|2.265||0.2993|TWO_SIDED|95.0|-6.81|2.1||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||Statistical analysis for awaken short of breath.||2.10|-6.81|0.2993
70887304|NCT01387607|141260644|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.03|STANDARD_ERROR_OF_MEAN|2.4485||0.0003|TWO_SIDED|95.0|4.21|13.85||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||Statistical analysis for sleep adequacy.||13.85|4.21|0.0003
70887305|NCT01387607|141260645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.286|STANDARD_ERROR_OF_MEAN|0.1114||0.0106|TWO_SIDED|95.0|0.07|0.51||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||Statistical analysis for quantity of sleep.||0.51|0.07|0.0106
70887306|NCT01387607|141260645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.194|STANDARD_ERROR_OF_MEAN|1.6428||0.0112|TWO_SIDED|95.0|0.96|7.43||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||Statistical analysis for somnolence||7.43|0.96|0.0112
70887307|NCT01387607|141260646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.059|STANDARD_ERROR_OF_MEAN|1.6438||0.0637|TWO_SIDED|95.0|-6.29|0.18||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||||0.18|-6.29|0.0637
70887308|NCT01387607|141260647|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.6767|TWO_SIDED|95.0|0.67|1.87||Logistic regression model includes treatment and pooled center as factors and baseline value as covariate.|Regression, Logistic|||||1.87|0.67|0.6767
70887309|NCT01387607|141260648|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.882|STANDARD_ERROR_OF_MEAN|0.1932|<|0.0001|TWO_SIDED|95.0|-1.26|-0.5||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||-0.50|-1.26|<0.0001
70887310|NCT01387607|141260649|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.172|STANDARD_ERROR_OF_MEAN|7.7785||0.0273|TWO_SIDED|95.0|-32.42|-1.92||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||-1.92|-32.42|0.0273
70887311|NCT01387607|141260650|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.0677||0.8082|TWO_SIDED|95.0|-0.12|0.15||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||0.15|-0.12|0.8082
70887312|NCT01387607|141260651|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.655|STANDARD_ERROR_OF_MEAN|0.1223|<|0.0001|TWO_SIDED|95.0|-0.89|-0.41||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||-0.41|-0.89|<0.0001
70887313|NCT01387607|141260652|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.396|STANDARD_ERROR_OF_MEAN|7.7309||0.3388|TWO_SIDED|95.0|-7.76|22.55||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||22.55|-7.76|0.3388
70887314|NCT01387607|141260653|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.765|STANDARD_ERROR_OF_MEAN|0.2115||0.0003|TWO_SIDED|95.0|0.35|1.18||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||1.18|0.35|0.0003
70887315|NCT01387607|141260654|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.8414||0.3186|TWO_SIDED|95.0|-2.5|0.82||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||0.82|-2.50|0.3186
70887316|NCT01387607|141260655|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|1.0404||0.7149|TWO_SIDED|95.0|-1.67|2.43||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||2.43|-1.67|0.7149
70887317|NCT01387607|141260656|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.785|STANDARD_ERROR_OF_MEAN|0.673||0.2442|TWO_SIDED|95.0|-0.54|2.11||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||2.11|-0.54|0.2442
70887318|NCT01387607|141260657|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.616|STANDARD_ERROR_OF_MEAN|2.4019||0.1332|TWO_SIDED|95.0|-8.34|1.11||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||1.11|-8.34|0.1332
70887319|NCT01387607|141260658|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.378|STANDARD_ERROR_OF_MEAN|0.3595||0.2934||95.0|-1.09|0.33||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||0.33|-1.09|0.2934
70887320|NCT01387607|141260659|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.3621||0.0226|TWO_SIDED|95.0|-1.54|-0.12||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||-0.12|-1.54|0.0226
70887321|NCT03238911|141260670|SUPERIORITY||Risk Difference (RD)|-67.0|||<|0.0001|TWO_SIDED|95.0|-77.4|-51.5|||Cochran-Mantel-Haenszel||Iron isomaltoside/ferric derisomaltose was compared to ferric carboxymaltose by estimation of the risk difference and the associated 95% CI, adjusting for strata (underlying disease and screening s-phosphate) using the Cochran-Mantel-Haenszel method.|"Power:~The power was set to 80%. Assuming incidences of 15% for iron isomaltoside/ferric derisomaltose and 40% for ferric carboxymaltose, 49 subjects in each treatment group were required to detect a difference between the treatment groups. The significance level was set to 5%."||-51.5|-77.4|<0.0001
70887322|NCT03238911|141260671|SUPERIORITY|||||||0.8979|||||||Log Rank|||The time with hypophosphatemia from baseline to day 35 was estimated by a Kaplan-Meier plot. The treatment groups were compared by a log-rank test. Only subjects who had one or more s-phosphate value(s) \<2 mg/dL were included.||||0.8979
70887323|NCT03238911|141260672|SUPERIORITY||Risk Difference (RD)|-39.2|||<|0.0001|TWO_SIDED|95.0|-52.2|-23.3|||Cochran-Mantel-Haenszel|||Iron isomaltoside/ferric derisomaltose will be compared to ferric carboxymaltose by estimation of the risk difference and the associated 95 % CI, adjusting for strata (type of underlying disease (women with IDA due to gynaecological blood losses; yes/no) and screening s-phosphate level (\< or ≥ 3.5 mg/dL)) using the Cochran-Mantel-Haenszel method.||-23.3|-52.2|<0.0001
70887324|NCT03238911|141260673|SUPERIORITY||Mean Difference (Final Values)|0.48|||<|0.0001|TWO_SIDED|95.0|0.31|0.65|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.65|0.31|<0.0001
70887325|NCT03238911|141260673|SUPERIORITY||Mean Difference (Final Values)|1.06|||<|0.0001|TWO_SIDED|95.0|0.85|1.27|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.27|0.85|<0.0001
70887326|NCT03238911|141260673|SUPERIORITY||Mean Difference (Final Values)|1.03|||<|0.0001|TWO_SIDED|95.0|0.81|1.25|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.25|0.81|<0.0001
70887327|NCT03238911|141260673|SUPERIORITY||Mean Difference (Final Values)|1.35|||<|0.0001|TWO_SIDED|95.0|1.1|1.6|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.60|1.10|<0.0001
70887328|NCT03238911|141260673|SUPERIORITY||Mean Difference (Final Values)|1.03|||<|0.0001|TWO_SIDED|95.0|0.75|1.32|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.32|0.75|<0.0001
70887329|NCT03238911|141260673|SUPERIORITY||Mean Difference (Final Values)|1.13|||<|0.0001|TWO_SIDED|95.0|0.86|1.39|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.39|0.86|<0.0001
70887330|NCT03238911|141260674|SUPERIORITY||Mean Difference (Final Values)|15.55|||<|0.0001|TWO_SIDED|95.0|10.32|20.79|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||20.79|10.32|<0.0001
70887331|NCT03238911|141260674|SUPERIORITY||Mean Difference (Final Values)|33.23|||<|0.0001|TWO_SIDED|95.0|26.62|39.84|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||39.84|26.62|<0.0001
70887332|NCT03238911|141260674|SUPERIORITY||Mean Difference (Final Values)|32.78|||<|0.0001|TWO_SIDED|95.0|25.71|39.84|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||39.84|25.71|<0.0001
70887333|NCT03238911|141260674|SUPERIORITY||Mean Difference (Final Values)|42.11|||<|0.0001|TWO_SIDED|95.0|33.89|50.32|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||50.32|33.89|<0.0001
70887334|NCT03238911|141260674|SUPERIORITY||Mean Difference (Final Values)|32.28|||<|0.0001|TWO_SIDED|95.0|23.09|41.48|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||41.48|23.09|<0.0001
70887335|NCT03238911|141260674|SUPERIORITY||Mean Difference (Final Values)|36.06|||<|0.0001|TWO_SIDED|95.0|27.33|44.78|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||44.78|27.33|<0.0001
70887336|NCT03238911|141260676|SUPERIORITY||Mean Difference (Final Values)|-105.74|||<|0.0001|TWO_SIDED|95.0|-131.04|-80.45|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-80.45|-131.04|<0.0001
70887337|NCT03238911|141260676|SUPERIORITY||Mean Difference (Final Values)|-60.76|||<|0.0001|TWO_SIDED|95.0|-82.95|-38.58|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-38.58|-82.95|<0.0001
70887338|NCT03238911|141260676|SUPERIORITY||Mean Difference (Final Values)|-293.23|||<|0.0001|TWO_SIDED|95.0|-368.15|-218.3|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-218.30|-368.15|<0.0001
70887339|NCT03238911|141260676|SUPERIORITY||Mean Difference (Final Values)|-117.47|||<|0.0001|TWO_SIDED|95.0|-151.6|-83.33|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-83.33|-151.60|<0.0001
70887340|NCT03238911|141260676|SUPERIORITY||Mean Difference (Final Values)|-71.21|||<|0.0001|TWO_SIDED|95.0|-101.8|-40.61|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-40.61|-101.80|<0.0001
70887341|NCT03238911|141260676|SUPERIORITY||Mean Difference (Final Values)|-37.16|||<|0.0001|TWO_SIDED|95.0|-54.92|-19.39|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-19.39|-54.92|<0.0001
70887342|NCT03238911|141260677|SUPERIORITY||Mean Difference (Final Values)|-99.1|||<|0.0001|TWO_SIDED|95.0|-136.42|-61.76|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-61.76|-136.42|<0.0001
70887343|NCT03238911|141260677|SUPERIORITY||Mean Difference (Final Values)|-49.3|||<|0.0001|TWO_SIDED|95.0|-72.8|-25.9|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-25.90|-72.80|<0.0001
70887344|NCT03238911|141260677|SUPERIORITY||Mean Difference (Final Values)|-191.3|||<|0.0001|TWO_SIDED|95.0|-242.47|-140.09|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-140.09|-242.47|<0.0001
70887345|NCT03238911|141260677|SUPERIORITY||Mean Difference (Final Values)|-100.7|||<|0.0001|TWO_SIDED|95.0|-137.19|-64.2|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-64.20|-137.19|<0.0001
70887346|NCT03238911|141260677|SUPERIORITY||Mean Difference (Final Values)|-48.4|||<|0.0001|TWO_SIDED|95.0|-71.78|-24.96|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-24.96|-71.78|<0.0001
70887347|NCT03238911|141260677|SUPERIORITY||Mean Difference (Final Values)|-15.0||||0.1411|TWO_SIDED|95.0|-35.04|5.06|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||5.06|-35.04|0.1411
70887348|NCT03238911|141260678|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.562|TWO_SIDED|95.0|-1.08|0.59|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.59|-1.08|0.5620
70887349|NCT03238911|141260678|SUPERIORITY||Mean Difference (Final Values)|1.75||||0.0126|TWO_SIDED|95.0|0.38|3.12|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||3.12|0.38|0.0126
70887350|NCT03238911|141260678|SUPERIORITY||Mean Difference (Final Values)|0.42||||0.608|TWO_SIDED|95.0|-1.19|2.02|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||2.02|-1.19|0.6080
70887351|NCT03238911|141260678|SUPERIORITY||Mean Difference (Final Values)|2.09||||0.0379|TWO_SIDED|95.0|0.12|4.05|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||4.05|0.12|0.0379
70887352|NCT03238911|141260678|SUPERIORITY||Mean Difference (Final Values)|1.17||||0.2368|TWO_SIDED|95.0|-0.78|3.12|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||3.12|-0.78|0.2368
70887353|NCT03238911|141260678|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.8287|TWO_SIDED|95.0|-2.18|1.75|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.75|-2.18|0.8287
70887354|NCT03238911|141260679|SUPERIORITY||Mean Difference (Final Values)|24.27|||<|0.0001|TWO_SIDED|95.0|18.81|29.73|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||29.73|18.81|<0.0001
70887355|NCT03238911|141260679|SUPERIORITY||Mean Difference (Final Values)|15.75|||<|0.0001|TWO_SIDED|95.0|8.83|22.67|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||22.67|8.83|<0.0001
70887356|NCT03238911|141260679|SUPERIORITY||Mean Difference (Final Values)|20.14|||<|0.0001|TWO_SIDED|95.0|12.07|28.22|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||28.22|12.07|<0.0001
70887357|NCT03238911|141260679|SUPERIORITY||Mean Difference (Final Values)|32.22|||<|0.0001|TWO_SIDED|95.0|25.49|38.96|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||38.96|25.49|<0.0001
70887358|NCT03238911|141260679|SUPERIORITY||Mean Difference (Final Values)|22.87|||<|0.0001|TWO_SIDED|95.0|14.79|30.95|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||30.95|14.79|<0.0001
70887359|NCT03238911|141260679|SUPERIORITY||Mean Difference (Final Values)|10.6||||0.0043|TWO_SIDED|95.0|3.39|17.82|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||17.82|3.39|0.0043
70887360|NCT03238911|141260680|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.0552|TWO_SIDED|95.0|-0.34|0.0|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.00|-0.34|0.0552
70887361|NCT03238911|141260680|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.0023|TWO_SIDED|95.0|-0.6|-0.13|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.13|-0.60|0.0023
70887362|NCT03238911|141260680|SUPERIORITY||Mean Difference (Final Values)|-0.51||||0.0008|TWO_SIDED|95.0|-0.8|-0.21|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.21|-0.80|0.0008
70887363|NCT03238911|141260680|SUPERIORITY||Mean Difference (Final Values)|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.11|-0.49|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.49|-1.11|<0.0001
70887364|NCT03238911|141260680|SUPERIORITY||Mean Difference (Final Values)|-0.64||||0.0006|TWO_SIDED|95.0|-1.01|-0.28|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.28|-1.01|0.0006
70887365|NCT03238911|141260680|SUPERIORITY||Mean Difference (Final Values)|-0.59||||0.0014|TWO_SIDED|95.0|-0.94|-0.23|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.23|-0.94|0.0014
70887366|NCT03238911|141260681|SUPERIORITY||Mean Difference (Final Values)|-1.13||||0.7447|TWO_SIDED|95.0|-7.96|5.71|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||5.71|-7.96|0.7447
70887367|NCT03238911|141260681|SUPERIORITY||Mean Difference (Final Values)|-9.7||||0.0363|TWO_SIDED|95.0|-18.78|-0.63|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.63|-18.78|0.0363
70887368|NCT03238911|141260681|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.9242|TWO_SIDED|95.0|-10.56|9.59|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||9.59|-10.56|0.9242
70887369|NCT03238911|141260681|SUPERIORITY||Mean Difference (Final Values)|-11.17||||0.0602|TWO_SIDED|95.0|-22.84|0.49|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.49|-22.84|0.0602
70887370|NCT03238911|141260681|SUPERIORITY||Mean Difference (Final Values)|-18.2||||0.0008|TWO_SIDED|95.0|-28.68|-7.73|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-7.73|-28.68|0.0008
70887371|NCT03238911|141260681|SUPERIORITY||Mean Difference (Final Values)|-19.79||||0.0031|TWO_SIDED|95.0|-32.75|-6.83|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-6.83|-32.75|0.0031
70887372|NCT03238911|141260682|SUPERIORITY||Mean Difference (Final Values)|0.037||||0.267|TWO_SIDED|95.0|-0.029|0.104|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.104|-0.029|0.2670
70887373|NCT03238911|141260682|SUPERIORITY||Mean Difference (Final Values)|0.085||||0.004|TWO_SIDED|95.0|0.028|0.142|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.142|0.028|0.0040
70887374|NCT03238911|141260682|SUPERIORITY||Mean Difference (Final Values)|0.064||||0.0472|TWO_SIDED|95.0|0.001|0.127|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.127|0.001|0.0472
70887375|NCT03238911|141260682|SUPERIORITY||Mean Difference (Final Values)|0.101||||0.005|TWO_SIDED|95.0|0.031|0.171|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.171|0.031|0.0050
70887376|NCT03238911|141260682|SUPERIORITY||Mean Difference (Final Values)|0.101||||0.0061|TWO_SIDED|95.0|0.029|0.172|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.172|0.029|0.0061
70887377|NCT03238911|141260682|SUPERIORITY||Mean Difference (Final Values)|0.055||||0.1282|TWO_SIDED|95.0|-0.016|0.126|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.126|-0.016|0.1282
70887378|NCT03238911|141260684|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.4618|TWO_SIDED|95.0|-0.82|0.37|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.37|-0.82|0.4618
70887379|NCT03238911|141260684|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.366|TWO_SIDED|95.0|-0.54|0.2|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.20|-0.54|0.3660
70887380|NCT03238911|141260684|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.858|TWO_SIDED|95.0|-0.25|0.3|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.30|-0.25|0.8580
70887381|NCT03238911|141260684|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.0257|TWO_SIDED|95.0|0.05|0.74|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.74|0.05|0.0257
70963576|NCT00323297|141432008|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.38|STANDARD_ERROR_OF_MEAN|11.722||0.5802|TWO_SIDED|90.0|-21.843|17.087||A sequential closed-testing procedure was implemented for all secondary endpoints. If no statistically significant treatment effect was found for the primary endpoint then statistical tests were not to be performed on the secondary endpoints.|ANCOVA|The mean difference in method of estimation is the difference between Sildenafil - placebo.||"The estimated sample size was based upon the primary endpoint. A sample size of 51 subjects per treatment group was required to detect a difference of 30 meters between treatments with 80% power at a one-sided significance level of 0.05, assuming a standard deviation of 60 meters.~This primary statistical analysis was carried for Week 12 data."||17.087|-21.843|0.5802
70887382|NCT03238911|141260684|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.0016|TWO_SIDED|95.0|0.19|0.77|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.77|0.19|0.0016
70887383|NCT03238911|141260684|SUPERIORITY||Mean Difference (Final Values)|0.42||||0.0185|TWO_SIDED|95.0|0.07|0.76|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.76|0.07|0.0185
70887384|NCT03238911|141260685|SUPERIORITY||Mean Difference (Final Values)|-14.84||||0.1922|TWO_SIDED|95.0|-37.26|7.57|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||7.57|-37.26|0.1922
70887385|NCT03238911|141260685|SUPERIORITY||Mean Difference (Final Values)|-18.28||||0.5601|TWO_SIDED|95.0|-80.24|43.68|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||43.68|-80.24|0.5601
70887386|NCT03238911|141260685|SUPERIORITY||Mean Difference (Final Values)|-71.02||||0.0459|TWO_SIDED|95.0|-140.74|-1.3|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-1.30|-140.74|0.0459
70887387|NCT03238911|141260685|SUPERIORITY||Mean Difference (Final Values)|-207.33|||<|0.0001|TWO_SIDED|95.0|-268.82|-145.84|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-145.84|-268.82|<0.0001
70887388|NCT03238911|141260685|SUPERIORITY||Mean Difference (Final Values)|-78.6||||0.001|TWO_SIDED|95.0|-124.81|-32.39|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-32.39|-124.81|0.0010
70887389|NCT03238911|141260685|SUPERIORITY||Mean Difference (Final Values)|-58.79||||0.0002|TWO_SIDED|95.0|-88.75|-28.82|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-28.82|-88.75|0.0002
70887390|NCT03238911|141260686|SUPERIORITY||Mean Difference (Final Values)|40.82|||<|0.0001|TWO_SIDED|95.0|26.3|55.33|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||55.33|26.30|<0.0001
70887391|NCT03238911|141260686|SUPERIORITY||Mean Difference (Final Values)|6.61||||0.0089|TWO_SIDED|95.0|1.69|11.53|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||11.53|1.69|0.0089
70887392|NCT03238911|141260686|SUPERIORITY||Mean Difference (Final Values)|-43.48|||<|0.0001|TWO_SIDED|95.0|-54.92|-32.03|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-32.03|-54.92|<0.0001
70963577|NCT00448435|141432027|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin + or - 15 L/min|Mean Difference (Net)|2.8|STANDARD_ERROR_OF_MEAN|5.91||0.6383||95.0|-9.1|14.69||Confidence Interval|Mixed Models Analysis|||Difference between treatments \[(SLM + FP)- SFC\](SE) 2.8 (5.91)||14.69|-9.10|0.6383
70963578|NCT01006265|141432060|SUPERIORITY||Treatment effect (rate ratio)|0.226|||<|0.0001|TWO_SIDED|95.0|0.133|0.384|||Negative binomial regression model|||||0.384|0.133|<0.0001
70963579|NCT01006265|141432060|SUPERIORITY||Treatment effect (rate ratio)|0.17|||<|0.0001|TWO_SIDED|95.0|0.1|0.289|||Negative binomial regression model|||||0.289|0.100|<0.0001
70963580|NCT01006265|141432060|SUPERIORITY||Treatment effect (rate ratio)|0.566||||0.0318|TWO_SIDED|95.0|0.337|0.952|||Negative binomial regression model|||||0.952|0.337|0.0318
70887393|NCT03238911|141260686|SUPERIORITY||Mean Difference (Final Values)|-1.68||||0.373|TWO_SIDED|95.0|-5.41|2.04|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||2.04|-5.41|0.3730
70887394|NCT03238911|141260686|SUPERIORITY||Mean Difference (Final Values)|-1.63||||0.4778|TWO_SIDED|95.0|-6.15|2.9|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||2.90|-6.15|0.4778
70887395|NCT03238911|141260686|SUPERIORITY||Mean Difference (Final Values)|-1.73||||0.3575|TWO_SIDED|95.0|-5.44|1.98|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.98|-5.44|0.3575
70887396|NCT03238911|141260687|SUPERIORITY||Risk Difference (RD)|-11.9||||0.005|TWO_SIDED|95.0|-20.1|-3.6|||Cochran-Mantel-Haenszel|||The rate difference with 95% Newcombe confidence interval, adjusted for stratum using the Cochran-Mantel-Haenszel method, could not be estimated due to lack of events. Thus, the unadjusted treatment difference is presented together with 95% Wald-based confidence interval. The p-value is based on the Cochran-Mantel-Haenszel statistics.||-3.6|-20.1|0.0050
70887397|NCT00991302|141260701|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|stratified by dosing complexity||"Treatment comparison was made using a Wilcoxon rank sum test stratified by dosing complexity.~The test was not stratified by region of enrollment due to dosing complexity and region of enrollment were almost identical: almost all (exception with two) participants in the US region were on QD and all participants in the Peru region were on BID or TID."||||0.52
70887398|NCT01709318|141260709|NON_INFERIORITY|Based on a longitudinal data analysis (LDA) model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|8.3|||||TWO_SIDED|95.0|-4.3|26.5|||||95% CI adjusted for multiplicity (Dunnett)|||26.5|-4.3|
70887399|NCT01709318|141260709|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|6.5|||||TWO_SIDED|95.0|-5.7|24.8|||||95% CI adjusted for multiplicity (Dunnett)|||24.8|-5.7|
70887400|NCT01709318|141260709|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|12.3|||||TWO_SIDED|95.0|-1.7|33.1|||||95% CI adjusted for multiplicity (Dunnett)|||33.1|-1.7|
70887401|NCT01709318|141260709|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|6.6|||||TWO_SIDED|95.0|-5.7|25.4|||||95% CI adjusted for multiplicity (Dunnett)|||25.4|-5.7|
70887402|NCT01709318|141260709|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|9.3|||||TWO_SIDED|95.0|-3.5|27.4|||||95% CI adjusted for multiplicity (Dunnett)|||27.4|-3.5|
70887403|NCT01709318|141260709|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-10.7|15.9|||||95% CI adjusted for multiplicity (Dunnett)|||15.9|-10.7|
70887404|NCT01709318|141260710|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|3.2|||||TWO_SIDED|95.0|-3.6|16.4|||||95% CI adjusted for multiplicity (Dunnett)|||16.4|-3.6|
70887405|NCT01709318|141260710|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-6.2|11.0|||||95% CI adjusted for multiplicity (Dunnett)|||11.0|-6.2|
70887406|NCT01709318|141260710|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|3.0|||||TWO_SIDED|95.0|-3.8|17.5|||||95% CI adjusted for multiplicity (Dunnett)|||17.5|-3.8|
70887407|NCT01709318|141260710|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|4.7|||||TWO_SIDED|95.0|-2.5|18.9|||||95% CI adjusted for multiplicity (Dunnett)|||18.9|-2.5|
70887408|NCT01709318|141260710|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|1.4|||||TWO_SIDED|95.0|-5.0|13.4|||||95% CI adjusted for multiplicity (Dunnett)|||13.4|-5.0|
70887409|NCT01709318|141260710|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-6.2|11.0|||||95% CI adjusted for multiplicity (Dunnett)|||11.0|-6.2|
70887410|NCT01709318|141260711|OTHER|Based on longitudinal data analysis (LDA) model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of Least Squares (LS) Mean|-0.08||||0.096|||||||LDA|||||||0.096
70887411|NCT01709318|141260711|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.03||||0.993|||||||LDA|||||||0.993
70887412|NCT01709318|141260711|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.08||||0.124|||||||LDA|||||||0.124
70887413|NCT01709318|141260711|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.05||||0.845|||||||LDA|||||||0.845
70887414|NCT01709318|141260711|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.04||||0.976|||||||LDA|||||||0.976
70887415|NCT01709318|141260711|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.03||||0.995|||||||LDA|||||||0.995
70887416|NCT01709318|141260712|OTHER|Based on longitudinal data analysis (LDA) model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of Least Squares (LS) Mean|-0.01||||1|||||||LDA|||||||1.000
70887417|NCT01709318|141260712|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|0.19||||0.996|||||||LDA|||||||0.996
70887418|NCT01709318|141260712|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.06||||1|||||||LDA|||||||1.000
70887419|NCT01709318|141260712|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.04||||1|||||||LDA|||||||1.000
70887420|NCT01709318|141260712|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|0.09||||1|||||||LDA|||||||1.000
70887421|NCT01709318|141260712|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.24||||0.998|||||||LDA|||||||0.998
70887422|NCT02047110|141260808|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.5||||0.2652|TWO_SIDED|90.0|-12.1|26.6||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the primary endpoint, ASAS 40 response at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as risankizumab 18 mg minus Placebo."|To control the type I error rate, the primary endpoint was tested in a hierarchical fixed sequence approach. The proportion of patients achieving ASAS 40 response at Week 12 was pairwise compared in the following sequence: risankizumab 180 mg vs. placebo (1.) and risankizumab 90 mg vs. placebo (2.). The significance level was 5% (1-sided). The comparison risankizumab 18 mg vs. placebo was not included in the formal testing sequence; an exploratory p-value was provided.||26.6|-12.1|0.2652
70963581|NCT03531788|141432065|OTHER|||||||||||||||||Activity counts from the ActiGraph GT9x activity monitor provide data per participant during testing of upper extremity activities/tasks and were collected while wearing the device (Kinova and WREX) and without the device (Kinova and WREX). For each upper extremity task, we summed all activity count data for all tasks completed. We then computed means and standard deviations. Data presented are within group data change and not between group data comparisons.|Due to the small sample size, we utilized change in activity count data when comparing two upper limb testing sessions: one without the use of an arm support device (Kinova or WREX) and one while using the arm support device. For each upper extremity task, we summed all activity count data for all tasks completed. We then computed means and standard deviations. Data presented are within group data change and not between group data comparisons.|||
70887423|NCT02047110|141260808|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.0||||0.4129|TWO_SIDED|90.0|-15.9|20.8||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the primary endpoint, ASAS 40 response at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 90 mg minus Placebo."|To control the type I error rate, the primary endpoint was tested in a hierarchical fixed sequence approach. The proportion of patients achieving ASAS 40 response at Week 12 was pairwise compared in the following sequence: risankizumab 180 mg vs. placebo (1.) and risankizumab 90 mg vs. placebo (2.). The significance level was 5% (1-sided). The comparison risankizumab 18 mg vs. placebo was not included in the formal testing sequence; an exploratory p-value was provided.||20.8|-15.9|0.4129
70887424|NCT02047110|141260808|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.5||||0.4243|TWO_SIDED|90.0|-21.8|17.0||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the primary endpoint, ASAS 40 response at Week 12, between treatment groups|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 180 mg minus Placebo."|To control the type I error rate, the primary endpoint was tested in a hierarchical fixed sequence approach. The proportion of patients achieving ASAS 40 response at Week 12 was pairwise compared in the following sequence: risankizumab 180 mg vs. placebo (1.) and risankizumab 90 mg vs. placebo (2.). The significance level was 5% (1-sided). The comparison risankizumab 18 mg vs. placebo was not included in the formal testing sequence; an exploratory p-value was provided.||17.0|-21.8|0.4243
70887425|NCT02047110|141260809|SUPERIORITY_OR_OTHER||Median estimate by Hodges-Lehmann method|-0.4||||0.0229|TWO_SIDED|90.0|-0.7|-0.1||One sided p-value from Wilcoxon rank-sum test|Wilcoxon rank-sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 18 mg minus Placebo."|||-0.1|-0.7|0.0229
70887426|NCT02047110|141260809|SUPERIORITY_OR_OTHER||Median estimate by Hodges-Lehmann method|-0.3||||0.1038|TWO_SIDED|90.0|-0.6|0.1||One sided p-value from Wilcoxon rank-sum test|Wilcoxon rank-sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 90 mg minus Placebo."|||0.1|-0.6|0.1038
70887427|NCT02047110|141260809|SUPERIORITY_OR_OTHER||Median estimate by Hodges-Lehmann method|-0.5||||0.0101|TWO_SIDED|90.0|-0.7|-0.1||One sided p-value from Wilcoxon rank-sum test|Wilcoxon rank-sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 180 mg minus Placebo."|||-0.1|-0.7|0.0101
70887428|NCT02047110|141260810|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.0||||0.0238|TWO_SIDED|90.0|-4.6|33.8||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as risankizumab 18 mg minus Placebo."|||33.8|-4.6|0.0238
70887429|NCT02047110|141260810|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.1||||0.012|TWO_SIDED|90.0|-0.8|35.3||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 90 mg minus Placebo."|||35.3|-0.8|0.0120
70887430|NCT02047110|141260810|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.5||||0.0465|TWO_SIDED|90.0|-7.1|31.4||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 180 mg minus Placebo."|||31.4|-7.1|0.0465
70887431|NCT02047110|141260811|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|90.0|-19.4|19.4|||||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as risankizumab 18 mg minus Placebo."|p-values are not presented as they were not meaningful; 3 treatment groups had only a single patient with partial remission.||19.4|-19.4|
70887432|NCT02047110|141260811|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1|||||TWO_SIDED|90.0|-18.3|18.3|||||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 90 mg minus Placebo."|p-values are not presented as they were not meaningful; 3 treatment groups had only a single patient with partial remission.||18.3|-18.3|
70887433|NCT02047110|141260811|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.5|||||TWO_SIDED|90.0|-12.1|26.6|||||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 180 mg minus Placebo."|p-values are not presented as they were not meaningful; 3 treatment groups had only a single patient with partial remission.||26.6|-12.1|
70887434|NCT02047110|141260812|SUPERIORITY_OR_OTHER||Risk Difference (RD)|25.0||||0.0092|TWO_SIDED|90.0|5.5|43.1||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as risankizumab 18 mg minus Placebo."|||43.1|5.5|0.0092
70887435|NCT02047110|141260812|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.3||||0.1243|TWO_SIDED|90.0|-5.9|30.5||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 90 mg minus Placebo."|||30.5|-5.9|0.1243
70887436|NCT02047110|141260812|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.5||||0.1198|TWO_SIDED|90.0|-7.1|31.4||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 180 mg minus Placebo."|||31.4|-7.1|0.1198
70887437|NCT02047110|141260813|SUPERIORITY_OR_OTHER||Median estimate by Hodges-Lehmann method|-0.4||||0.1241|TWO_SIDED|90.0|-1.0|0.2||One sided p-value from Wilcoxon rank-sum test|Wilcoxon rank-sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 18 mg minus Placebo."|||0.2|-1.0|0.1241
70887438|NCT02047110|141260813|SUPERIORITY_OR_OTHER||Median estimate by Hodges-Lehmann method|0.3||||0.3033|TWO_SIDED|90.0|-0.5|1.0||One sided p-value from Wilcoxon rank-sum test|Wilcoxon rank-sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 90 mg minus Placebo."|||1.0|-0.5|0.3033
70887439|NCT02047110|141260813|SUPERIORITY_OR_OTHER||Median estimate by Hodges-Lehmann method|-0.2||||0.3203|TWO_SIDED|90.0|-0.8|0.4||One sided p-value from Wilcoxon rank-sum test|Wilcoxon rank-sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 180 mg minus Placebo."|||0.4|-0.8|0.3203
70887440|NCT02047110|141260814|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.5||||0.2639|TWO_SIDED|90.0|-12.1|26.6||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 24, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as risankizumab 18 mg minus Placebo."|||26.6|-12.1|0.2639
70887441|NCT02047110|141260814|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.1||||0.2691|TWO_SIDED|90.0|-10.9|25.7||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 24, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 90 mg minus Placebo."|||25.7|-10.9|0.2691
70887442|NCT02047110|141260814|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.5||||0.4174|TWO_SIDED|90.0|-21.8|17.0||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 24, between treatment groups|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 180 mg minus Placebo."|||17.0|-21.8|0.4174
70887443|NCT01959581|141260843|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||Repeated measures ANOVA||||<.05
70887444|NCT03773757|141260851|SUPERIORITY|Longitudinal measures of NPI-Q patient over 24 months were compared between the two groups using mixed effects model that included a group indicator variable, time since baseline, and an interaction between group and time as independent variables. Unstructured variance-covariance matrix was used to adjust for within-subject correlations over time. Predicted differences in mean scores between the two groups at each time point were estimated using the contrast procedures in the mixed model.||||||0.8719|||||||Mixed Models Analysis|||||||0.8719
70887445|NCT03773757|141260852|SUPERIORITY|Longitudinal measures of SM-EOLD over 24 months were compared between the two groups using mixed effects model that included a group indicator variable, time since baseline, and an interaction between group and time as independent variables. Unstructured variance-covariance matrix was used to adjust for within-subject correlations over time. Predicted differences in mean scores between the two groups at each time point were estimated using the contrast procedures in the mixed model.||||||0.8389|||||||Mixed Models Analysis|||||||0.8389
70887446|NCT03773757|141260853|SUPERIORITY|Longitudinal measures of PHQ-8 over 24 months were compared between the two groups using mixed effects model that included a group indicator variable, time since baseline, and an interaction between group and time as independent variables. Unstructured variance-covariance matrix was used to adjust for within-subject correlations over time. Predicted differences in mean scores between the two groups at each time point were estimated using the contrast procedures in the mixed model.||||||0.3431|||||||Mixed Models Analysis|||||||0.3431
70887447|NCT03773757|141260854|SUPERIORITY|Longitudinal measures of NPI-Q caregiver distress over 24 months were compared between the two groups using mixed effects model including a group indicator variable, time since baseline, and an interaction between group and time as independent variables. Unstructured variance-covariance matrix was used to adjust for within-subject correlations over time. Predicted differences in mean scores between the two groups at each time point were estimated using the contrast procedures in the mixed model.||||||0.6612|||||||Mixed Models Analysis|||||||0.6612
70887448|NCT03773757|141260855|SUPERIORITY|A zero-inflated Poisson (ZIP) model was used to compare the mean numbers of hospitalization/ED events between the two groups. The ZIP model consists of a combination of a standard Poisson distribution for count data and a binary logistic regression model to account for additional zero events exceeding what would be expected from an underlying Poisson distribution.||||||0.0007|||||||Zero-Inflated Poisson Regression Model|||||||0.0007
70887449|NCT01109316|141260856|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.48|||||TWO_SIDED|95.0|0.2|0.76|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Age stratum + Baseline HbA1c.|This was the primary gated analysis.||0.76|0.20|
70887450|NCT01109316|141260857|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.22|||||TWO_SIDED|95.0|-0.07|0.52|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Age Stratum + Baseline HbA1c; where participant is treated as a random effect.|||0.52|-0.07|
70887451|NCT01109316|141260857|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.25|||||TWO_SIDED|95.0|-0.05|0.56|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Age Stratum + Baseline HbA1c; where participant is treated as a random effect.|||0.56|-0.05|
70887452|NCT01109316|141260858|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.11|||||TWO_SIDED|95.0|-0.29|0.51|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.|||0.51|-0.29|
70887453|NCT01109316|141260858|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.16|||||TWO_SIDED|95.0|-0.41|0.73|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.|||0.73|-0.41|
70887454|NCT01109316|141260858|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.03|||||TWO_SIDED|95.0|-0.18|0.24|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.|||0.24|-0.18|
70887455|NCT01109316|141260858|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.14|||||TWO_SIDED|95.0|-0.56|0.27|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.|||0.27|-0.56|
70887456|NCT01109316|141260858|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.06|||||TWO_SIDED|95.0|-0.48|0.6|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.|||0.60|-0.48|
70887457|NCT01109316|141260858|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.1|||||TWO_SIDED|95.0|-0.85|0.65|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.|||0.65|-0.85|
70887458|NCT01109316|141260859|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.06|||||TWO_SIDED|95.0|-0.02|0.14|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Period + Sequence + Baseline HbA1c.|||0.14|-0.02|
70887459|NCT01109316|141260859|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.09|||||TWO_SIDED|95.0|0.01|0.18|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Period + Sequence + Baseline HbA1c.|||0.18|0.01|
70887460|NCT01109316|141260860|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.5|1.75|||||Odds Ratio of HbA1c ≤6.5% for Insulin Lispro 6 Day versus Insulin Aspart 6 Day.|||1.75|0.50|
70887461|NCT01109316|141260860|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.29|1.67|||||Odds Ratio of HbA1c ≤6.5% for Insulin Lispro 6 Day versus Insulin Lispro 2 Day.|||1.67|0.29|
70887462|NCT01109316|141260860|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.56|1.41|||||Odds Ratio of HbA1c \<7% for Insulin Lispro 6 Day versus Insulin Aspart 6 Day.|||1.41|0.56|
70887463|NCT01109316|141260860|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.66|1.64|||||Odds Ratio of HbA1c \<7% for Insulin Lispro 6 Day versus Insulin Lispro 2 Day.|||1.64|0.66|
70887464|NCT01109316|141260861|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.|Gart's Test|||||||1.00
70887465|NCT01109316|141260862|SUPERIORITY_OR_OTHER|||||||0.164||95.0||||P-value computed using a negative binomial test including factors for treatment, period, and sequence.|Negative Binomial Test|||||||0.164
70887466|NCT01109316|141260862|SUPERIORITY_OR_OTHER|||||||0.185||95.0||||P-value computed using a negative binomial test including factors for treatment, period, and sequence.|Negative Binomial Test|||||||0.185
70887467|NCT01109316|141260863|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||P-value for Premature Reservoir Change. P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.|Gart's Test|||||||0.736
70887468|NCT01109316|141260863|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value for Premature Reservoir Change. P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.|Gart's Test|||||||0.006
70887469|NCT01109316|141260863|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for Premature Infusion Set Change. P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.|Gart's Test|||||||1.00
70887470|NCT01109316|141260863|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value for Premature Infusion Set Change. P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.|Gart's Test|||||||0.017
70887471|NCT01109316|141260864|SUPERIORITY_OR_OTHER|||||||0.471||95.0||||P-value for Premature Reservoir Change. P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test|||||||0.471
70887472|NCT01109316|141260864|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Premature Reservoir Change. P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test|||||||<0.001
70887473|NCT01109316|141260864|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||P-value for Premature Infusion Set Change. P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test|||||||0.737
70887474|NCT01109316|141260864|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Premature Infusion Set Change. P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test|||||||<0.001
70887475|NCT01109316|141260866|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test|||||||0.006
70887476|NCT01109316|141260866|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test|||||||0.002
70887477|NCT01109316|141260867|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Body Weight.|Crossover Model|||||||0.060
70887478|NCT01109316|141260867|SUPERIORITY_OR_OTHER|||||||0.486||95.0||||P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Body Weight.|Crossover Model|||||||0.486
70887479|NCT01109316|141260868|SUPERIORITY_OR_OTHER|||||||0.056||95.0||||P-value is for Systolic Blood Pressure. P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Systolic Blood Pressure.|Crossover Model|||||||0.056
70887480|NCT01109316|141260868|SUPERIORITY_OR_OTHER|||||||0.805||95.0||||P-value is for Systolic Blood Pressure. P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Systolic Blood Pressure.|Crossover Model|||||||0.805
70887481|NCT01109316|141260868|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||P-value is for Diastolic Blood Pressure. P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Diastolic Blood Pressure.|Crossover Model|||||||0.020
70887482|NCT01109316|141260868|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-value is for Diastolic Blood Pressure. P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Diastolic Blood Pressure.|Crossover Model|||||||0.051
70887483|NCT01302392|141260876|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.975||||0.4172|TWO_SIDED|95.0|0.76|1.249||Based on 1-sided test.|Log Rank|Analysis was stratified by the number of previous therapies (3 vs 4 vs ≥ 5) and geographical region (Europe vs. non-Europe)||||1.249|0.760|0.4172
70887484|NCT01702233|141260888|NON_INFERIORITY_OR_EQUIVALENCE|All statistical analyses were of exploratory nature. A one-sided test of non-inferiority of Traumeel®S with respect to dexamethasone at level 0.025 was computed using an analysis of covariance (ANCOVA) model with treatment group as qualitative factor and the baseline value of the abduction rotation pain VAS for active external rotation as a covariate. The test decision was based on a one-sided 97.5% confidence interval . The non-inferiority margin was set to 13 mm on a 0-100 mm VAS scale.|Mean Difference (Final Values)|13.0|STANDARD_DEVIATION|13.0|<|0.05|ONE_SIDED|95.0||97.5|||ANCOVA|||||97.5||<0.05
70887485|NCT04646616|141260906|NON_INFERIORITY|This is a single-group, of outcome measured at baseline and at 3 months. We hypothesized there would be an improvement or sustainability of the protective behaviours.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.13||0.28|TWO_SIDED|95.0|-0.12|0.39|||t-test, 2 sided|||This is a single-group study. Selected outcomes were measured at baseline (first interaction with the community popular opinion leader (POL) and 3 months after.||0.39|-0.12|0.28
70887486|NCT04646616|141260907|OTHER|Test of proportions|difference in proportion|-0.007|STANDARD_ERROR_OF_MEAN|0.04||0.85|TWO_SIDED|95.0|-0.08|0.07|||Test of proportions|||Two sample test of proportions, testing whether the proportion of participants who lack health access at baseline and 3 months is equal (null hypothesis)||0.07|-0.08|0.85
70887487|NCT04646616|141260908|OTHER|Test of proportions.|difference in proportion|0.07|STANDARD_ERROR_OF_MEAN|0.58||0.19|TWO_SIDED|95.0|-0.04|0.19|||Test of proportions|||Test of proportions. Testing whether the proportion of participants who had a SAVAME factor at baseline and 3 months is equal (null hypothesis)||0.19|-0.04|0.19
70887488|NCT04646616|141260909|OTHER|Test of proportions.|difference in proportion|0.067|STANDARD_ERROR_OF_MEAN|0.06||0.23|TWO_SIDED|95.0|-0.04|0.18|||Test of proportions|||Test of proportions. Testing whether the proportion of participants who lack access to SAVAME related services at baseline and 3 months is equal (null hypothesis)||0.18|-0.04|0.23
70887489|NCT03049813|141260910|SUPERIORITY|||||||0.027||||||One-sided p value|Regression, Logistic|Adjusted for baseline year of study participation, problematic substance use, social cognition, community functioning, and negative symptoms - anergia||||||0.027
70887490|NCT03049813|141260910|SUPERIORITY|||||||0.0765||||||1-sided p-value|Chi-squared|||||||0.0765
70887491|NCT03049813|141260911|SUPERIORITY|||||||0.062||||||One-sided p value|Regression, Cox|Adjusting for baseline year of study participation, problematic substance use, social cognition, community functioning, and negative symptoms anergia||||||0.062
70887492|NCT03049813|141260912|SUPERIORITY|||||||0.006||||||Adjusting for baseline year of study participation, problematic substance use, social cognition, community functioning, negative symptoms - anergia|Regression, Linear|||||||0.006
70887493|NCT03049813|141260913|SUPERIORITY|||||||0.013||||||Mixed-effects linear regression models. Covariates include: baseline year, problematic substance use, social cognition, community functioning, and negative symptoms (anergia). One-sided p value.|Regression, Linear|||||||0.013
70887494|NCT03049813|141260914|SUPERIORITY|||||||0.019||||||Mixed-effects linear regression models. Covariates include: baseline year, problematic substance use, social cognition, community functioning, and negative symptoms (anergia). One sided p-value.|Regression, Linear|||||||0.019
70887495|NCT03049813|141260915|SUPERIORITY|||||||0.692||||||Mixed-effects linear regression models. Covariates include: baseline year, problematic substance use, social cognition, community functioning, and negative symptoms (anergia).|Regression, Linear|||For this analysis, only participants who completed both pre-test and posttest were included. If someone completed a pre-test SSPA, but not a posttest SSPA, they were not included in the analysis.||||0.692
70887496|NCT00550836|141260917|SUPERIORITY|||||||0.36|||||||Log Rank|||It was calculated that 39 participants randomized in a 1:1 fashion between the 2 arms would have 80% to detect a difference in median survival of 6 vs. 9.7 months for GE vs. PGE respectively with a minimum follow up of 6 months. Sample size was determined using a 1-sided log-rank test at alpha=0.20.||||0.36
70887497|NCT00550836|141260918|OTHER|||||||1|||||||Fisher Exact|||||||1.0
70887498|NCT00550836|141260919|SUPERIORITY|||||||0.419|||||||Log Rank|||||||0.419
70887499|NCT00550836|141260920|OTHER|||||||0.36|||||||Log Rank|||||||0.36
70887500|NCT01696032|141260933|SUPERIORITY|||||||0.0654|||||||Log Rank|||||||0.0654
70887501|NCT01192152|141260945|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of saxagliptin.|Ratio of geometric least squares means|1.045|||||TWO_SIDED|90.0|1.025|1.065|||||Ratio = Treatment B/Treatment A. Geometric least squares means values presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of a 5-mg saxagliptin tablet plus two 500-mg metformin XR tablets under fed conditions, then 24 subjects would have provided 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 94% and 99% power to conclude BE with respect to Cmax and AUC0-inf.||1.065|1.025|
70887502|NCT01192152|141260945|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|103.05||||||95.0||||||||Geometric least squares means for Treatment B||||
70887503|NCT01192152|141260945|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|98.61||||||95.0||||||||Geometric least squares means for Treatment A||||
70887504|NCT01192152|141260946|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|1.035|||||TWO_SIDED|90.0|1.009|1.062|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|||1.062|1.009|
70887505|NCT01192152|141260946|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|101.16||||||95.0||||||||Geometric least squares means for Treatment B||||
70887506|NCT01192152|141260946|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|97.72||||||95.0||||||||Geometric least squares means for Treatment A||||
70887507|NCT01192152|141260948|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of saxagliptin.|Ratio of geometric least squares mean|0.999|||||TWO_SIDED|90.0|0.948|1.053|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of a 5-mg saxagliptin tablet plus two 500-mg metformin XR tablets under fed conditions, then 24 subjects would have provided 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 94% and 99% power to conclude BE with respect to Cmax and AUC0-inf.||1.053|0.948|
70887508|NCT01192152|141260948|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|24.85||||||95.0||||||||Geometric least squares means for Treatment B||||
70887509|NCT01192152|141260948|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|24.88||||||95.0||||||||Geometric least squares means for Treatment A||||
70887510|NCT01192152|141260965|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of metformin.|ratio of geometric least squares means|0.894|||||TWO_SIDED|90.0|0.833|0.959|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of a 5-mg saxagliptin tablet plus two 500-mg metformin XR tablets under fed conditions, then 24 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided at least 99% power to conclude BE with respect to Cmax and AUC0-inf.||0.959|0.833|
70887511|NCT01192152|141260965|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|8713.4||||||95.0||||||||Geometric least squares mean for Treatment B||||
70887512|NCT01192152|141260965|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|9746.3||||||95.0||||||||Geometric least squares mean for Treatment A||||
70887513|NCT01192152|141260966|SUPERIORITY_OR_OTHER||ratio of geometric least squares means|0.906|||||TWO_SIDED|90.0|0.848|0.968|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|||0.968|0.848|
70887514|NCT01192152|141260966|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|8377.8||||||95.0||||||||Geometric least squares means for Treatment B||||
70887515|NCT01192152|141260966|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|9246.8||||||95.0||||||||Geometric least squares mean for Treatment A||||
70887516|NCT01192152|141260968|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of metformin.|ratio of geometric least squares means|0.917|||||TWO_SIDED|90.0|0.859|0.98|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of a 5-mg saxagliptin tablet plus two 500-mg metformin XR tablets under fed conditions, then 24 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided at least 99% power to conclude BE with respect to Cmax and AUC0-inf.||0.980|0.859|
70887517|NCT01192152|141260968|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|1055.9||||||95.0||||||||Geometric least squares means for Treatment B||||
70887518|NCT01192152|141260968|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|1151.2||||||95.0||||||||Geometric least squares means for Treatment A||||
70887519|NCT00378703|141261022|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||Log Rank|||Progression-free survival was compared between Arm B (bevacizumab and temsirolimus) and Arm A (bevacizumab alone) using stratified log rank test, stratified on prior cytokine or vaccine therapy and risk category (low/intermediate/high risk)||||0.89
70887520|NCT00378703|141261022|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||Log Rank|||Progression-free survival was compared between Arm C (bevacizumab and sorafenib) and Arm A (bevacizumab alone) using stratified log rank test, stratified on prior cytokine or vaccine therapy and risk category (low/intermediate/high risk).||||0.54
70887521|NCT00378703|141261022|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||Log Rank|||Progression-free survival was compared between Arm D (sorafenib and temsirolimus) and Arm A (bevacizumab alone) using stratified log rank test, stratified on prior cytokine or vaccine therapy and risk category (low/intermediate/high risk).||||0.68
70887522|NCT00378703|141261025|SUPERIORITY_OR_OTHER|||||||0.0076|TWO_SIDED|||||Each combination arm was compared with the bevacizumab alone arm. Since there were 3 pairwise comparisons, a Bonferroni--adjusted p-value of 0.017 was considered to be statistically significant.|Fisher Exact|||The response rate of each combination arm was compared to that of the bevacizumab alone arm.||||0.0076
70887523|NCT00378703|141261025|SUPERIORITY_OR_OTHER|||||||0.0085|TWO_SIDED|||||Each combination arm was compared with the bevacizumab alone arm. Since there were 3 pairwise comparisons, a Bonferroni--adjusted p-value of 0.017 was considered to be statistically significant.|Fisher Exact|||The response rate of each combination arm was compared to that of the bevacizumab alone arm.||||0.0085
70887524|NCT00378703|141261025|SUPERIORITY_OR_OTHER|||||||0.3006|TWO_SIDED|||||Each combination arm was compared with the bevacizumab alone arm. Since there were 3 pairwise comparisons, a Bonferroni--adjusted p-value of 0.017 was considered to be statistically significant.|Fisher Exact|||The response rate of each combination arm was compared to that of the bevacizumab alone arm.||||0.3006
70887525|NCT01009099|141261035|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED||||||ANCOVA|Co-variates included in the analysis were time walked on the constant workrate test at baseline and adherence (sessions completed/expected).||The outcomes compared were time walked on the constant workrate treadmill test measured in minutes.||||0.63
70887526|NCT02702401|141261036|SUPERIORITY||Hazard Ratio (HR)|0.775||||0.0186|TWO_SIDED|95.0|0.609|0.987|||Log Rank|One-sided p-value stratified by geographic region, macrovascular invasion and alfa-fetoprotein level.|Cox regression model with Efron's method (treatment as covariate) stratified by geographic region, macrovascular invasion and alfa-fetoprotein level|||0.987|0.609|0.0186
70887527|NCT02702401|141261037|SUPERIORITY||Hazard Ratio (HR)|0.781||||0.0238|TWO_SIDED|95.0|0.611|0.998|||Log Rank|One-sided p-value stratified by geographic region, macrovascular invasion and alfa-fetoprotein level.|Cox regression model with Efron's method (treatment as covariate) stratified by geographic region, macrovascular invasion and alfa-fetoprotein level|||0.998|0.611|0.0238
70887528|NCT02702401|141261038|OTHER||Difference in Percent|13.8|||||TWO_SIDED|95.0|7.7|19.5|||||Miettinen \& Nurminen method stratified by geographic region, macrovascular invasion and alfa-fetoprotein level|||19.5|7.7|
70887529|NCT02702401|141261040|OTHER||Hazard Ratio (HR)|0.688||||0.0011|TWO_SIDED|95.0|0.54|0.877||One-sided p-value stratified by geographic region, macrovascular invasion and alfa-fetoprotein level.|Log Rank||Cox regression model with Efron's method (treatment as covariate) stratified by geographic region, macrovascular invasion and alfa-fetoprotein level|||0.877|0.540|0.0011
70887530|NCT00247728|141261044|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sample size is based on the paper 'Two-stage selection and testing design for comparative clinical trials', Thall, PF, Simon, R and Ellenberg, SS. Biometrika (1988),75,(2),303-310.||||||0.072||95.0|||||Chi-squared|||||||0.072
70887531|NCT00247728|141261044|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sample size is based on the paper 'Two-stage selection and testing design for comparative clinical trials', Thall, PF, Simon, R and Ellenberg, SS. Biometrika (1988),75,(2),303-310.||||||0.298||95.0|||||Chi-squared|||||||0.298
70887532|NCT00247728|141261045|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.59||||0.087||95.0|||||Mantel Haenszel|||||||0.087
70887533|NCT00247728|141261045|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.653||95.0|||||Mantel Haenszel|||||||0.653
70887534|NCT04292730|141261056|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0174|TWO_SIDED|95.0|1.092|2.483||P-value was calculated using proportional odds model with treatment as the independent variable.|Proportional odds model|||Primary analysis||2.483|1.092|0.0174
70887535|NCT04292730|141261056|SUPERIORITY||Odds Ratio (OR)|1.31||||0.1826|TWO_SIDED|95.0|0.88|1.952||P-value was calculated using proportional odds model with treatment as the independent variable.|Proportional odds model|||Primary analysis||1.952|0.880|0.1826
70887536|NCT04292730|141261056|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0168|TWO_SIDED|95.0|1.095|2.497||P-value was calculated using proportional odds model with treatment as the independent variable and baseline clinical status as a nominal covariate.|Proportional odds model|||Secondary analysis||2.497|1.095|0.0168
70887537|NCT04292730|141261056|SUPERIORITY||Odds Ratio (OR)|1.29||||0.2186|TWO_SIDED|95.0|0.862|1.917||P-value was calculated using proportional odds model with treatment as the independent variable and baseline clinical status as a nominal covariate.|Proportional odds model|||Secondary analysis||1.917|0.862|0.2186
70887538|NCT04292730|141261057|SUPERIORITY||Difference in the Percentages|4.8||||0.3633|TWO_SIDED|95.0|-5.2|14.7||P-value was calculated from the Fisher exact test to compare each RDV group and the SOC group.|Fisher Exact|||||14.7|-5.2|0.3633
70887539|NCT04292730|141261057|SUPERIORITY||Difference in the Percentages|12.0||||0.0201|TWO_SIDED|95.0|1.6|21.8||P-value was calculated from the Fisher exact test to compare each RDV group and the SOC group.|Fisher Exact|||||21.8|1.6|0.0201
70887540|NCT01556204|141261125|SUPERIORITY_OR_OTHER|||||||0.71||||||This p-value is from a single comparison between two arms for operative time.|t-test, 2 sided|||Variance estimates for this power analysis were taken from Nezhat C, et al, 2010. We determined that 37 subjects in each arm were needed to detect a difference of ≥ 32 minutes in operating time between conventional and robotic surgery for endometriosis with 80% power and a significance level of 0.05.||||0.71
70887541|NCT01556204|141261126|SUPERIORITY_OR_OTHER|||||||0.53||||||This applies to Row title: Baseline|Mixed Models Analysis|||Secondary analysis for pain at baseline for robotic vs conventional laparoscopy for endometriosis.||||0.53
70887542|NCT01556204|141261126|SUPERIORITY_OR_OTHER|||||||0.53||||||This applies to Row title: 6-weeks|Mixed Models Analysis|||Pain scores at 6 weeks comparison between robotic and laparoscopy.||||0.53
70887543|NCT01556204|141261126|SUPERIORITY_OR_OTHER|||||||0.48||||||This applies to Row title: 6-months|Mixed Models Analysis|||Pain scores at 6 months for robotic vs laparoscopy.||||0.48
70887544|NCT06893809|141261187|SUPERIORITY||Median Difference (Net)|10.0|STANDARD_DEVIATION|5.0||0.05|TWO_SIDED|95.0|10.0|20.0|||Kruskal-Wallis|||Sixty male patients scheduled for TURP surgery were divided into three equal groups. The results were evaluated at a 95% confidence interval, with significance set at p \< 0.05. This was achieved using SPSS 15.0. Between-group comparisons were performed using One-way ANOVA, Kruskal-Wallis, Wilcoxon Signed Ranks, and Friedman tests. Within-group comparisons used Wilcoxon Signed Ranks tests, and Friedman tests were used for differences over time.||20|10|0.05
70887545|NCT06893809|141261187|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0|>|0.05|TWO_SIDED|95.0|0.0|0.0||No adjustment for multiple comparisons was applied. Non-parametric method used due to ordinal scale structure.|Kruskal-Wallis||Patient and surgeon satisfaction were compared across study arms.|The aim of this analysis is to compare the three groups in terms of patient and surgeon satisfaction using a superiority approach. The null hypothesis is that there is no difference in satisfaction scores between the groups. Statistical significance was set at p \< 0.05.||0|0|>0.05
70887546|NCT06893809|141261189|SUPERIORITY||Mean Difference (Final Values)|1.05||||0.05|TWO_SIDED|95.0|0.5|1.6|||Kruskal-Wallis|Non-parametric test used due to ordinal scale and non-normal distribution.|Sensory block levels compared across study arms using numerical dermatomal codes.|||1.6|0.5|0.05
70887547|NCT06893809|141261191|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.22|<|0.05|TWO_SIDED|95.0|0.07|0.93|||Kruskal-Wallis||Dermatomal regression levels were compared across groups at 60 minutes.|||0.93|0.07|<0.05
70887548|NCT02652624|141261216|NON_INFERIORITY|A sample size of 470 participants (\~235 participants per treatment group) would provide at least 87% power to detect a non-inferiority margin of 4% difference in the percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 between the 2 treatment groups. This was based on the assumptions that both treatment groups have 2% of participants with HIV-1 RNA ≥ 50 copies/mL (based on Gilead Genvoya and Stribild studies) and that the significance level of the test is at a 1-sided 0.025 level.|Difference in percentages|0.0|||||TWO_SIDED|95.001|-2.9|2.9|||||The difference in percentages between treatment groups and their 95.001% confidence intervals (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The null hypothesis was that the percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 in the B/F/TAF group was at least 4% higher than the rate in the SBR group; the alternative hypothesis was that the percentage of participants with HIV-1 RNA ≥ 50 copies/mL in the B/F/TAF group was less than 4% higher than that in the SBR group.||2.9|-2.9|
70887549|NCT02652624|141261216|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
70887550|NCT02652624|141261217|NON_INFERIORITY|The non-inferiority of B/F/TAF would be established if the lower bound of the 2-sided 95.001% CI of the difference between the treatment groups (B/F/TAF group - SBR group) in the percentage of participants with HIV-1 RNA \< 50 copies/mL is greater than -10%.|Difference in percentages|0.4|||||TWO_SIDED|95.001|-3.7|4.5|||||The difference in percentages between treatment groups and their 95.001% CIs were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|||4.5|-3.7|
70887551|NCT02652624|141261217|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
70887552|NCT02652624|141261218|OTHER||Difference in least square means|3.0||||0.84|TWO_SIDED|95.0|-27.0|34.0|||ANOVA||Difference in least squares means and its 95% CI were from ANOVA model with treatment group as a fixed effect in the model.|||34|-27|0.84
70887553|NCT01560624|141261221|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0275|TWO_SIDED|95.0|0.56|0.97|||Cox proportion-hazard model|||||0.97|0.56|0.0275
70887554|NCT01560624|141261221|SUPERIORITY|||||||0.0391|||||||Log Rank|||||||0.0391
70887555|NCT01560624|141261222|SUPERIORITY||Hodges Lehmann estimate location shift|7.0||||0.0913|TWO_SIDED|95.0|0.0|16.0|||ANCOVA|||||16.0|0|0.0913
70887556|NCT01560624|141261223|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70887557|NCT01560624|141261224|SUPERIORITY|||||||0.0028|||||||Fisher Exact|||||||0.0028
70887558|NCT01797536|141261228|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (GMR)|0.61|||||TWO_SIDED|90.0|0.34|1.08|||||GMR= Mild Hepatic Insufficiency Geometric Mean (GM) divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.08|0.34|
70887559|NCT01797536|141261228|SUPERIORITY_OR_OTHER||GMR|0.72|||||TWO_SIDED|90.0|0.4|1.31|||||GMR = Moderate Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.31|0.40|
70887560|NCT01797536|141261228|SUPERIORITY_OR_OTHER||GMR|0.88|||||TWO_SIDED|90.0|0.48|1.61|||||GMR = Severe Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.61|0.48|
70887561|NCT01797536|141261229|SUPERIORITY_OR_OTHER||GMR|0.6|||||TWO_SIDED|90.0|0.34|1.05|||||GMR = Mild Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.05|0.34|
70887562|NCT01797536|141261229|SUPERIORITY_OR_OTHER||GMR|0.64|||||TWO_SIDED|90.0|0.35|1.14|||||GMR = Moderate Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.14|0.35|
70887563|NCT01797536|141261229|SUPERIORITY_OR_OTHER||GMR|0.63|||||TWO_SIDED|90.0|0.35|1.13|||||GMR = Severe Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.13|0.35|
70887564|NCT01797536|141261230|SUPERIORITY_OR_OTHER||GMR|0.58|||||TWO_SIDED|90.0|0.32|1.05|||||GMR = Mild Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.05|0.32|
70887565|NCT01797536|141261230|SUPERIORITY_OR_OTHER||GMR|0.64|||||TWO_SIDED|90.0|0.35|1.14|||||GMR = Moderate Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.14|0.35|
70887566|NCT01797536|141261230|SUPERIORITY_OR_OTHER||GMR|0.58|||||TWO_SIDED|90.0|0.32|1.08|||||GMR = Severe Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.08|0.32|
70887567|NCT01797536|141261231|SUPERIORITY_OR_OTHER||GMR|0.61|||||TWO_SIDED|90.0|0.34|1.08|||||GMR = Mild Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.08|0.34|
70887568|NCT01797536|141261231|SUPERIORITY_OR_OTHER||GMR|0.69|||||TWO_SIDED|90.0|0.38|1.25|||||GMR = Moderate Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.25|0.38|
70887569|NCT01797536|141261231|SUPERIORITY_OR_OTHER||GMR|0.78|||||TWO_SIDED|90.0|0.43|1.43|||||GMR = Severe Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.43|0.43|
70887570|NCT03228680|141261243|NON_INFERIORITY|The pre-specified non-inferiority (NI) margin was -3.0 oocytes. The NI was evaluated based on the two-sided 95% CI from the ANOVA on 'number of oocytes retrieved' with treatment and AMH stratum as fixed factors.|Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-2.3|-0.1|||||If the lower bound of 95% CI was well above pre-specified NI limit of -3.0 oocytes, then NI of FE 999049 to FOLLISTIM with respect to number of oocytes retrieved in women undergoing controlled ovarian stimulation would be demonstrated|Mean number of oocytes retrieved.||-0.1|-2.3|
70887571|NCT03228680|141261244|OTHER||Risk Difference (RD)|1.6|||||TWO_SIDED|95.0|-7.5|10.6|||||The difference (FE 999049-FOLLISTIM) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across AMH strata.|Percentage of participants with at least one gestational sac 5-6 weeks after transfer.||10.6|-7.5|
70887572|NCT03228680|141261245|OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-9.5|9.6|||||The difference (FE 999049-FOLLISTIM) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across AMH strata.|Percentage of participants with positive beta-hCG.||9.6|-9.5|
70887573|NCT03228680|141261246|OTHER||Risk Difference (RD)|2.0|||||TWO_SIDED|95.0|-6.7|10.8|||||The difference (FE 999049-FOLLISTIM) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across AMH strata.|Percentage of participants with vital pregnancy.||10.8|-6.7|
70887574|NCT03228680|141261247|OTHER||Risk Difference (RD)|1.9|||||TWO_SIDED|95.0|-8.9|12.8|||||The difference (FE 999049-FOLLISTIM) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across AMH strata.|Percentage of implanted embryos 5-6 weeks after transfer.||12.8|-8.9|
70887575|NCT03228680|141261249|SUPERIORITY|||||||0.244||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with blastocyst transfer cancellation.||||0.244
70887576|NCT03228680|141261250|SUPERIORITY|||||||0.254||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with \<4 oocytes retrieved (low response).||||0.254
70887577|NCT03228680|141261250|SUPERIORITY|||||||0.041||||||P-value was based on likelihood ratio test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with 4-7 oocytes retrieved (moderate response).||||0.041
70887578|NCT03228680|141261250|SUPERIORITY|||||||0.705||||||P-value was based on likelihood ratio test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with 8-14 oocytes retrieved (targeted response).||||0.705
70887579|NCT03228680|141261250|SUPERIORITY|||||||0.183||||||P-value was based on likelihood ratio test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with 15-19 oocytes retrieved (hyperresponse).||||0.183
70887580|NCT03228680|141261250|SUPERIORITY|||||||0.03||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with \>= (more than equal to) 20 oocytes retrieved (severe hyperresponse).||||0.030
70887581|NCT03228680|141261251|SUPERIORITY|||||||0.893||||||P-value was based on likelihood ratio chi-square test.|Chi-squared|||Proportion of participants with extreme ovarian responses: AMH \< 15 pmol/L (\<4 oocytes retrieved)||||0.893
70887582|NCT03228680|141261251|SUPERIORITY|||||||0.002||||||P-value was based on likelihood ratio chi-square test.|Chi-squared|||Proportion of participants with extreme ovarian responses: AMH \>= 15 pmol/L (\>=15 oocytes retrieved)||||0.002
70887583|NCT03228680|141261251|SUPERIORITY|||||||0.021||||||P-value based on likelihood ratio chi-square test.|Chi-squared|||Proportion of participants with extreme ovarian responses: AMH \>= 15 pmol/L (\>=20 oocytes retrieved)||||0.021
70887584|NCT03228680|141261253|SUPERIORITY|||||||0.017||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportions of participants with early OHSS (any grade).||||0.017
70887585|NCT03228680|141261253|SUPERIORITY|||||||0.035||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with early OHSS (moderate/severe).||||0.035
70887586|NCT03228680|141261253|SUPERIORITY|||||||0.006||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with early OHSS (any grade) and/or preventive interventions.||||0.006
70887587|NCT03228680|141261253|SUPERIORITY|||||||0.009||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with early OHSS (moderate/severe) and/or preventive interventions.||||0.009
70887588|NCT03228680|141261254|SUPERIORITY|||||||0.968||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportions of participants with late OHSS (any grade).||||0.968
70887589|NCT03228680|141261254|SUPERIORITY|||||||0.582||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportions of participants with late OHSS (moderate/severe).||||0.582
70887590|NCT03228680|141261255|SUPERIORITY|||||||0.198||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of follicles on stimulation Day 6 was analyzed.||||0.198
70887591|NCT03228680|141261256|SUPERIORITY|||||||0.036||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of follicles at end-of-stimulation was analyzed.||||0.036
70887592|NCT03228680|141261257|SUPERIORITY|||||||0.592||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The average size of 3 largest follicles was analyzed.||||0.592
70887593|NCT03228680|141261258|SUPERIORITY|||||||0.286||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The average size of 3 largest follicles was analyzed.||||0.286
70887594|NCT03228680|141261259|SUPERIORITY|||||||0.395||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The fertilization rate (number of oocytes with 2 pronuclei divided by the number of oocytes retrieved) was analyzed.||||0.395
70887595|NCT03228680|141261260|SUPERIORITY|||||||0.001||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of embryos on Day 3 was analyzed.||||0.001
70887596|NCT03228680|141261260|SUPERIORITY|||||||0.004||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of good-quality embryos on Day 3 was analyzed.||||0.004
70887597|NCT03228680|141261261|SUPERIORITY||||||<|0.001||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of blastocysts on Day 5 was analyzed.||||<.001
70887598|NCT03228680|141261261|SUPERIORITY||||||<|0.001||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of good-quality blastocysts on Day 5 was analyzed.||||<0.001
70887599|NCT03228680|141261262|SUPERIORITY||Mean ratio|1.03||||0.228|TWO_SIDED|95.0|0.98|1.09||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of FSH on stimulation Day 6.||1.09|0.98|0.228
70887600|NCT03228680|141261262|SUPERIORITY||Mean ratio|0.97||||0.777|TWO_SIDED|95.0|0.81|1.17||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of LH on stimulation Day 6.||1.17|0.81|0.777
70887601|NCT03228680|141261263|SUPERIORITY||Mean ratio|0.89|||<|0.001|TWO_SIDED|95.0|0.84|0.94||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of FSH at end-of-stimulation.||0.94|0.84|<0.001
70887602|NCT03228680|141261263|SUPERIORITY||Mean ratio|1.17||||0.057|TWO_SIDED|95.0|1.0|1.39||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of LH at end-of-stimulation.||1.39|1.00|0.057
70887603|NCT03228680|141261264|SUPERIORITY||Mean ratio|0.81||||0.002|TWO_SIDED|95.0|0.71|0.93||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of estradiol on stimulation Day 6.||0.93|0.71|0.002
70887604|NCT03228680|141261265|SUPERIORITY||Mean ratio|0.85||||0.003|TWO_SIDED|95.0|0.76|0.95||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of estradiol at end-of-stimulation.||0.95|0.76|0.003
70887605|NCT03228680|141261266|SUPERIORITY||Mean ratio|1.02||||0.814|TWO_SIDED|95.0|0.89|1.16||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of progesterone on stimulation Day 6.||1.16|0.89|0.814
70887606|NCT03228680|141261267|SUPERIORITY||Mean ratio|0.78|||<|0.001|TWO_SIDED|95.0|0.68|0.88||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of progesterone levels at end-of-stimulation.||0.88|0.68|<0.001
70887607|NCT03228680|141261268|SUPERIORITY||Mean ratio|0.82|||<|0.001|TWO_SIDED|95.0|0.73|0.92||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of Inhibin A on stimulation Day 6.||0.92|0.73|<0.001
70887608|NCT03228680|141261269|SUPERIORITY||Mean ratio|0.8|||<|0.001|TWO_SIDED|95.0|0.72|0.88||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of Inhibin A at end-of-stimulation.||0.88|0.72|<0.001
70887609|NCT03228680|141261270|SUPERIORITY||Mean ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.75|0.93||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of Inhibin B on stimulation Day 6.||0.93|0.75|<0.001
70887610|NCT03228680|141261271|SUPERIORITY||Mean ratio|0.88||||0.027|TWO_SIDED|95.0|0.79|0.99||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of Inhibin B at end-of-stimulation.||0.99|0.79|0.027
70887611|NCT03228680|141261272|SUPERIORITY|||||||0.694||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of stimulation days at end-of-stimulation.||||0.694
70887612|NCT01268644|141261282|SUPERIORITY|||||||0.14||||||P value comparing baseline to week 12|Mixed Models Analysis|||||||0.14
70887613|NCT01268644|141261283|SUPERIORITY|||||||0.01||||||P value comparing week 0 with week 12.|Mixed Models Analysis|||||||0.01
70887614|NCT01268644|141261284|SUPERIORITY|||||||0.009||||||P value comparing week 0 to week 12.|Mixed Models Analysis|||||||0.009
70887615|NCT01268644|141261285|SUPERIORITY|||||||0.75|||||||Mixed Models Analysis|||||||0.75
70887616|NCT01416194|141261286|SUPERIORITY||Hazard Ratio (HR)|0.4|||<|0.01|TWO_SIDED|95.0|0.3|0.7|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.7|0.3|<0.01
70887617|NCT01416194|141261286|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.91|TWO_SIDED|95.0|0.4|2.2|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||2.2|0.4|0.91
70887618|NCT01416194|141261287|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.01|TWO_SIDED|95.0|0.3|0.7|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.7|0.3|<0.01
70887619|NCT01416194|141261287|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.76|TWO_SIDED|95.0|0.5|2.4|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||2.4|0.5|0.76
70887620|NCT01416194|141261288|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.01|TWO_SIDED|95.0|0.3|0.9|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.9|0.3|0.01
70887621|NCT01416194|141261288|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.37|TWO_SIDED|95.0|0.4|1.5|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.5|0.4|0.37
70887622|NCT01416194|141261289|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.1|TWO_SIDED|95.0|0.5|1.1|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.1|0.5|0.10
70887623|NCT01416194|141261289|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.19|TWO_SIDED|95.0|0.4|1.2|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.2|0.4|0.19
70887624|NCT01416194|141261290|SUPERIORITY||Hazard Ratio (HR)|0.4|||<|0.01|TWO_SIDED|95.0|0.3|0.7|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.7|0.3|<0.01
70887625|NCT01416194|141261290|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9|TWO_SIDED|95.0|0.4|2.1|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||2.1|0.4|0.90
70887626|NCT01416194|141261291|SUPERIORITY||Hazard Ratio (HR)|1.9|||<|0.01|TWO_SIDED|95.0|1.4|2.5|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||2.5|1.4|<0.01
70887627|NCT01416194|141261291|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.74|TWO_SIDED|95.0|0.7|1.3|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.3|0.7|0.74
70887628|NCT01416194|141261292|SUPERIORITY||Hazard Ratio (HR)|0.4|||<|0.01|TWO_SIDED|95.0|0.3|0.6|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.6|0.3|<0.01
70887629|NCT01416194|141261292|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.01|TWO_SIDED|95.0|0.4|0.9|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.9|0.4|0.01
70887630|NCT01416194|141261293|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.01|TWO_SIDED|95.0|0.1|0.5|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.5|0.1|<0.01
70887631|NCT01416194|141261293|SUPERIORITY||Hazard Ratio (HR)|0.4||||0.06|TWO_SIDED|95.0|0.2|1.1|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.1|0.2|0.06
70887632|NCT01416194|141261294|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.01|TWO_SIDED|95.0|0.3|0.7|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.7|0.3|<0.01
70887633|NCT01416194|141261294|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.38|TWO_SIDED|95.0|0.5|1.4|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.4|0.5|0.38
70887634|NCT01416194|141261296|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.24|TWO_SIDED|95.0|0.9|1.5|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.5|0.9|0.24
70887635|NCT01416194|141261296|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.59|TWO_SIDED|95.0|0.8|1.6|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.6|0.8|0.59
70887636|NCT01416194|141261297|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.03|TWO_SIDED|95.0|0.6|1.0|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.0|0.6|0.03
70887637|NCT01416194|141261297|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.19|TWO_SIDED|95.0|0.6|1.1|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.1|0.6|0.19
70887638|NCT01416194|141261298|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.01|TWO_SIDED|95.0|0.2|0.5|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.5|0.2|<0.01
70887639|NCT01416194|141261298|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.24|TWO_SIDED|95.0|0.3|1.3|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.3|0.3|0.24
70887640|NCT01222494|141261299|SUPERIORITY|||||||0.01||||||The p-value refers to the treatment group term in the model. The a priori threshold for statistical significance in this planned primary test was p \< 0.05.|ANCOVA|||An ANCOVA was used to test for differences between groups at endpoint, controlling for baseline values.||||0.01
70887641|NCT01222494|141261300|SUPERIORITY|||||||0.04||||||The p-value refers to the treatment group term in the model. The a priori threshold for statistical significance in this planned primary test was p \< 0.05.|ANCOVA|||An ANCOVA was used to test for differences between groups at endpoint, controlling for baseline values.||||0.04
70887642|NCT01222494|141261301|SUPERIORITY|||||||0.7||||||The p-value refers to the treatment group term in the model. The a priori threshold for statistical significance in this planned primary test was p \< 0.05.|ANCOVA|||An ANCOVA was used to test for differences between groups at endpoint, controlling for baseline values.||||0.70
70887643|NCT01222494|141261302|SUPERIORITY|||||||0.003||||||The p-value refers to the treatment group term in the model. The a priori threshold for statistical significance in this planned primary test was p \< 0.05.|ANCOVA|||An ANCOVA was used to test for differences between groups at endpoint, controlling for baseline values.||||0.003
70887644|NCT00436280|141261348|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.512|||||TWO_SIDED|95.0|0.217|1.206|||||Comparing GCB versus non-GCB|Comparing GCB versus non-GCB||1.206|0.217|
70887645|NCT00436280|141261349|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.878|||||TWO_SIDED|95.0|0.388|1.989|||||Comparing High Expression versus Low Expression|Comparing High Expression versus Low Expression||1.989|0.388|
70887646|NCT01049919|141261356|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.224|TWO_SIDED|95.0|0.31|1.31|||Proportional Hazards Regression|||||1.31|0.31|0.224
70887647|NCT01049919|141261357|SUPERIORITY|||||||0.671||||||Treatment-by-week p-value is reported.|Repeated measures model|The statistical analysis model includes treatment group, week, treatment-by-week, and baseline pain measurement.||||||0.671
70887648|NCT01049919|141261358|SUPERIORITY|||||||0.714||||||Treatment-by-week p-value is reported.|Repeated measures model|The statistical analysis model includes treatment group, week, treatment-by-week, and baseline pain measurement.||||||0.714
70887649|NCT01049919|141261360|SUPERIORITY||Hazard Ratio (HR)|0.37||||0.018|TWO_SIDED|95.0|0.16|0.85|||Proportional Hazards Regression|||||0.85|0.16|0.018
70887650|NCT01663259|141261367|OTHER||||||||||||||||||Estimates of proportion event-free at 1 and 2 years calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals were calculated by the Greenwood method. All analyses were performed using SAS v9.4 software and R version 3.5.2.|||
70887651|NCT01663259|141261368|OTHER||||||||||||||||||Survival proportion estimates at 1 and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method. All analyses were performed using SAS v9.4 software and R version 3.5.2.|||
70887652|NCT01663259|141261369|OTHER||||||||||||||||||Estimates of proportion LRP event-free at 1 and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method. All analyses were performed using SAS v9.4 software and R version 3.5.2.|||
70887653|NCT01532687|141261380|SUPERIORITY|Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.||||||0.017|||||||Gehan-Wilcoxon|||Statistical results are for the full randomized population (n = 54). The study was originally designed with overall one-sided alpha of 5%, where a total of 73 patients (36 in the gemcitabine + placebo arm, and 37 in the gemcitabine + pazopanib arm) were required to achieve 80% power to detect a 2.5 month increase in median PFS (a hazard ratio of 0.55) between the two treatment arms. Study was closed early by the sponsor due to slow accrual and funds and thus was under powered.||||0.017
70887654|NCT01532687|141261380|OTHER|Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.||||||0.195|||||||Gehan-Wilcoxon|||Comparison between the two arms for the liposarcoma subgroup||||0.195
70887655|NCT01532687|141261380|OTHER|Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.||||||0.079|||||||Gehan-Wilcoxon|||Statistical results are for the 'other' sarcoma subgroup (n = 38)||||0.079
70887656|NCT01532687|141261382|SUPERIORITY|Analysis was not powered for secondary endpoints. Given the study closed early due to slow enrollment, we do not anticipate detecting a statistical difference between the two groups||||||0.5||||||Yate's continuity correction was applied because of the number of subjects and successes (n = 4)|One-sided Proportions Test|||Statistical results are for the full randomized population (n = 54). The study tests whether gemcitabine plus pazopanib is superior to gemcitabine plus placebo (one-sided proportion test with Yate's continuity correction)||||0.5
70887657|NCT01532687|141261382|SUPERIORITY|||||||0.3||||||Yate's continuity correction was applied because of small number of participants (n = 16) and successes (n = 2).|One-sided Proportion Test|||Statistical results are for the Liposarcoma group (n = 16). The study tests whether gemcitabine plus pazopanib is superior to gemcitabine plus placebo (one-sided proportion test with Yate's continuity correction). Analysis was not powered for the secondary endpoints. Given the study closed early due to slow enrollment we do not anticipate detecting a statistical difference between the groups.||||0.3
70887658|NCT01532687|141261382|SUPERIORITY|||||||0.8||||||Yate's continuity correction was applied because of the small number of participants and successes (n = 2).|One-sided Proportion Test|||Statistical results are for the Other Sarcoma group (n = 38). The study tests whether gemcitabine plus pazopanib is superior to gemcitabine plus placebo (one-sided proportion test with Yate's continuity correction). Analysis was not powered for secondary endpoints. Given the study closed early due to slow enrollment, we do not anticipate detecting a statistical difference between the two groups.||||0.8
70887659|NCT01532687|141261383|OTHER|Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.||||||0.481|||||||Gehan-Wilcoxon|||Overall survival estimated among all randomized participants (n = 54)||||0.481
70887660|NCT01532687|141261383|OTHER|Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.||||||0.353|||||||Gehan-Wilcoxon|||Overall survival compared between the two arms for the liposarcoma subgroup (n = 16)||||0.353
70887661|NCT01532687|141261383|OTHER|Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.||||||0.408|||||||Gehan-Wilcoxon|||Overall survival comparison between the two treatment arms for the other sarcoma group (n = 38)||||0.408
70887662|NCT03160703|141261384|SUPERIORITY||Mean Difference (Net)|-0.02||||0.2681|TWO_SIDED|95.0|-0.05|0.01||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||0.01|-0.05|0.2681
70887663|NCT03160703|141261384|SUPERIORITY||Mean Difference (Net)|-0.05||||0.0043|TWO_SIDED|95.0|-0.08|-0.02||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||-0.02|-0.08|0.0043
70887664|NCT03160703|141261384|SUPERIORITY||Mean Difference (Net)|-0.08|||<|0.0001|TWO_SIDED|95.0|-0.12|-0.05||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||-0.05|-0.12|<.0001
70887665|NCT03160703|141261384|SUPERIORITY||Mean Difference (Final Values)|-0.11|||<|0.0001|TWO_SIDED|95.0|-0.15|-0.08||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||-0.08|-0.15|<.0001
70887666|NCT03160703|141261384|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.0779|TWO_SIDED|95.0|0.0|0.06||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||0.06|-0.00|0.0779
70887667|NCT03160703|141261384|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.0001|TWO_SIDED|95.0|0.03|0.1||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||0.10|0.03|0.0001
70887668|NCT00047463|141261397|SUPERIORITY_OR_OTHER|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that the groups would be similar in tolerance. This was a pilot study so we did not do a power calculation.||||0.26
70887669|NCT04589559|141261407|OTHER|Paired-samples t-test|Mean change score|-1.5||||0.152|TWO_SIDED|95.0|-3.67|0.67|||t-test, 2 sided|Paired-samples t-test|A negative value of the estimation parameter of mean change score indicates a reduction in cardiac-related interoceptive fear.|||0.67|-3.67|0.152
70887670|NCT04589559|141261408|OTHER|Paired-samples t-test|Mean change score|-6.2||||0.031|TWO_SIDED|95.0|-11.71|-0.69|||t-test, 2 sided|Paired-samples t-test|A negative value of the estimation parameter of mean change score indicates a reduction in trait anxiety.|||-0.69|-11.71|0.031
70887671|NCT04589559|141261409|OTHER|Paired-samples t-test|Mean change score|-1.9||||0.323|TWO_SIDED|95.0|-6.01|2.21|||t-test, 2 sided|Paired-samples t-test|A negative value of the estimation parameter of mean change score indicates a reduction in negative affect.|||2.21|-6.01|0.323
70887672|NCT04589559|141261410|OTHER|Paired-samples t-test|Mean change in the measure|0.58||||0.112|TWO_SIDED|95.0|-0.16|1.33|||t-test, 2 sided|Paired-samples t-test|A positive value of the estimation parameter of mean change in the measure indicates an increase in heart rate variability.|||1.33|-0.16|0.112
70887673|NCT02832674|141261433|SUPERIORITY|||||||0.05|TWO_SIDED|90.0|||||Fisher Exact|||The primary endpoint was an evaluation of the proportion of subjects with ≥ 20 mm2 lift at Day 90.||||0.05
70887674|NCT02832674|141261434|OTHER|Binomial test of proportions||||||0.025|TWO_SIDED|95.0|||||Chi-squared||||The summary included number and percentage of subjects in each of the categories and the 2 sided Clopper-Pearson 95% CI. a binomial test of proportions tested the improvement at Day 90 and Day 180.|||0.025
70887675|NCT02832674|141261435|OTHER|||||||0.025|TWO_SIDED|95.0|||||Chi-squared|||Analysis of all effectiveness endpoints was conducted on the ITT population and on the PP population.|The summary included number and percentage of subjects in each of the categories and the 2 sided Clopper-Pearson 95% CI. a binomial test of proportions tested the improvement at Day 90 and Day 180.|||0.025
70887676|NCT02832674|141261436|OTHER|||||||0.025|TWO_SIDED|95.0|||||Chi-squared||||The summary included number and percentage of subjects in each of the categories and the 2 sided Clopper-Pearson 95% CI. a binomial test of proportions tested the improvement at Day 90 and Day 180.|||0.025
70887677|NCT02832674|141261437|OTHER|||||||0.025|TWO_SIDED|95.0|||||Chi-squared||||The summary included number and percentage of subjects in each of the categories and the 2 sided Clopper-Pearson 95% CI. a binomial test of proportions tested the improvement at Day 90 and Day 180.|||0.025
70887678|NCT02832674|141261438|OTHER|||||||0.025|TWO_SIDED|95.0|||||Chi-squared||||The summary included number and percentage of subjects in each of the categories and the 2 sided Clopper-Pearson 95% CI. a binomial test of proportions tested the improvement at Day 90 and Day 180.|||0.025
70887679|NCT01448850|141261439|SUPERIORITY_OR_OTHER||Rate ratio|0.92||||0.645|TWO_SIDED|90.0|0.68|1.25||Data was analyzed using Poisson regression with Pearson correction, adjusting for treatment, background therapy and history of previous exacerbations.|Poisson regression|||||1.25|0.68|0.645
70887680|NCT02214147|141261449|OTHER|The effect of hepatic impairment on alisertib PK. Combined analysis of moderate and severe hepatic impairment in reference to normal hepatic function.|Least Squares Geometric Mean Ratio|1.42|||||TWO_SIDED|90.0|1.12|1.8|||||Least Squares Geometric Means Ratio= Moderate + Severe Hepatic Impairment/Normal Hepatic Function|||1.80|1.12|
70887681|NCT02214147|141261450|OTHER|The effect of hepatic impairment on alisertib PK. Combined analysis of moderate and severe hepatic impairment in reference to normal hepatic function.|Least Squares Geometric Mean Ratio|3.21|||||TWO_SIDED|90.0|2.33|4.43|||||Least Squares Geometric Mean Ratio=Moderate + Severe Hepatic Impairment/Normal Hepatic Function|||4.43|2.33|
70887682|NCT02214147|141261451|OTHER|The effect of hepatic impairment on alisertib PK. Combined analysis of moderate and severe hepatic impairment in reference to normal hepatic function.|Least Squares Geometric Mean Ratio|2.54|||||TWO_SIDED|90.0|1.84|3.53|||||Least Squares Geometric Mean Ratio=Moderate + Severe Hepatic Impairment/Normal Hepatic Function|||3.53|1.84|
70887683|NCT00280566|141261460|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0104|||||||Log Rank|alpha = 0.05 level of significance||Equality of Survival Curves across the treatment groups.||||0.0104
70887684|NCT00280566|141261461|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0047|||||||Log Rank|No adjustment made for multiple comparisons||alpha = 0.05 level of significance||||0.0047
70887685|NCT00280566|141261462|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0205||||||No adjustment made for multiple comparisons|Log Rank|||alpha = 0.05 level of significance||||0.0205
70887686|NCT00280566|141261463|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.55||0.1247|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 1: Difference in Change during Period 2 MMRM ANCOVA: center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1247
70887687|NCT00280566|141261463|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.62||0.7515|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance|Mean Difference (Final Values) = Least Squares Mean|Week 2 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.7515
70887688|NCT00280566|141261463|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.62||0.3074|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.3074
70887689|NCT00280566|141261463|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.71||0.0758|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0758
70887690|NCT00280566|141261463|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|0.82||0.0162|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0162
70887691|NCT00280566|141261463|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.01|STANDARD_ERROR_OF_MEAN|0.83||0.0003|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0003
70887692|NCT00280566|141261463|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.21|STANDARD_ERROR_OF_MEAN|0.98||0.0242|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0242
70887693|NCT00280566|141261463|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.71|STANDARD_ERROR_OF_MEAN|0.71||0.0161|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0161
70887694|NCT00280566|141261464|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.09||0.0088|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 1 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0088
70887695|NCT00280566|141261464|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.3677|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 2 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.3677
70887696|NCT00280566|141261464|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.1||0.0734|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0734
70887697|NCT00280566|141261464|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.11||0.9166|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.9166
70887698|NCT00280566|141261464|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.13||0.2791|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.2791
70887699|NCT00280566|141261464|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.16||0.146|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1460
70887700|NCT00280566|141261464|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.15||0.7301|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.7301
70887701|NCT00280566|141261464|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8162|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.8162
70887702|NCT00280566|141261465|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.15||0.0013|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 1 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0013
70887703|NCT00280566|141261465|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.17||0.1167|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 2 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1167
70887704|NCT00280566|141261465|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0188|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0188
70887705|NCT00280566|141261465|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.16||0.3413|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.3413
70887706|NCT00280566|141261465|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.16||0.276|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.2760
70887707|NCT00280566|141261465|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.19||0.0085|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0085
70887708|NCT00280566|141261465|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.18||0.1317|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1317
70887709|NCT00280566|141261465|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.18||0.1666|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1666
70887710|NCT00280566|141261466|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.29|STANDARD_ERROR_OF_MEAN|0.75||0.0023|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 1 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0023
70887711|NCT00280566|141261466|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.34|STANDARD_ERROR_OF_MEAN|0.91||0.1412|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 2 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate||||0.1412
70887712|NCT00280566|141261466|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.49|STANDARD_ERROR_OF_MEAN|0.87||0.0861|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0861
70887713|NCT00280566|141261466|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.82||0.5992|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.5992
70887714|NCT00280566|141261466|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.76||0.5873|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.5873
70887715|NCT00280566|141261466|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|0.78||0.2116|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.2116
70887716|NCT00280566|141261466|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.68||0.1847|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1847
70887717|NCT00280566|141261466|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.82||0.9972|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.9972
70887718|NCT00280566|141261467|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.93||0.5954|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.5954
70887719|NCT00280566|141261467|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.89|STANDARD_ERROR_OF_MEAN|0.93||0.3414|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.3414
70887720|NCT00280566|141261467|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|1.23||0.9745|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate||||0.9745
70887721|NCT00280566|141261467|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|1.47||0.5627|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.5627
70887722|NCT00280566|141261467|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|1.1||0.741|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.7410
70887723|NCT00280566|141261467|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.88||0.9632|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.9632
70887724|NCT00280566|141261468|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.22||0.9538|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.9538
70887725|NCT00280566|141261468|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.25||0.8541|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.8541
70887726|NCT00280566|141261468|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.32||0.1084|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1084
70887727|NCT00280566|141261468|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.27||0.038|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0380
70887728|NCT00280566|141261468|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.35||0.2649|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.2649
70887729|NCT00280566|141261468|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.27||0.2394|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.2394
70887730|NCT00280566|141261469|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.29||0.8117|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.8117
70887731|NCT00280566|141261469|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.26||0.0443|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0443
70887732|NCT00280566|141261469|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.28||0.3039|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.3039
70887733|NCT00280566|141261469|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.46||0.9953|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.9953
70887734|NCT00280566|141261469|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.32||0.1653|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1653
70887735|NCT00280566|141261469|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.32||0.5771|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.5771
70887736|NCT04542070|141261471|NON_INFERIORITY|Non-inferiority concluded if the upper limit of a two-sided 95% confidence interval for the difference in percentage of participants with HIV-1 RNA ≥ 50 c/mL at Month 12 (OLI and BIK)/Month 11 (D2I) between the two treatment arms (Q2M - BIK) is less than 4%.|Difference in percentage|0.9|||||TWO_SIDED|95.0|-0.5|2.2|||||Difference in percentage = percentage of Q2M - percentage of BIK|||2.2|-0.5|
70887737|NCT04542070|141261471|NON_INFERIORITY|Non-inferiority concluded if the upper limit of a two-sided 95% confidence interval for the difference in percentage of participants with HIV-1 RNA ≥ 50 c/mL at Month 12 (OLI and BIK)/Month 11 (D2I) between the two treatment arms (Q2M - BIK) is less than 4%.|Adjusted difference in percentage|0.9|||||TWO_SIDED|95.0|-0.5|2.2|||||Adjusted difference in percentage = percentage of Q2M - percentage of BIK. Based on cochran-mantel haenszel stratified analysis was adjusted for the baseline stratification factors gender at birth and baseline BMI.|||2.2|-0.5|
70887738|NCT04542070|141261472|NON_INFERIORITY|Non-inferiority concluded if the upper limit of a two-sided 95% confidence interval for the difference in percentage of participants with HIV-1 RNA ≥ 50 c/mL at Month 12 (OLI and BIK)/Month 11 (D2I) between the two treatment arms (Q2M - BIK) is less than 4%.|Difference in percentage|0.7|||||TWO_SIDED|95.0|-0.6|2.0|||||Difference in percentage = percentage of Q2M - percentage of BIK|||2.0|-0.6|
70887739|NCT04542070|141261472|NON_INFERIORITY|Non-inferiority concluded if the upper limit of a two-sided 95% confidence interval for the difference in percentage of participants with HIV-1 RNA ≥ 50 c/mL at Month 12 (OLI and BIK)/Month 11 (D2I) between the two treatment arms (Q2M - BIK) is less than 4%.|Adjusted difference in percentage|0.7|||||TWO_SIDED|95.0|-0.7|2.0|||||Adjusted difference in percentage = percentage of Q2M - percentage of BIK. Based on cochran-mantel haenszel stratified analysis was adjusted for the baseline stratification factors gender at birth and baseline BMI.|||2.0|-0.7|
70887740|NCT02188485|141261508|SUPERIORITY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.72||0.278|TWO_SIDED||||||Mixed Models Analysis||This mean difference is not identical to the mean difference presented in the summary table because this mean difference was adjusted for random effects in the model.|Thwarted belonging (INQ-TB) at 10 week follow-up||||.278
70887741|NCT02188485|141261508|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.38||0.591|TWO_SIDED||||||Mixed Models Analysis||This mean difference is not identical to the mean difference presented in the summary table because this mean difference was adjusted for random effects in the model.|Perceived burden (INQ-PB) at 10-week follow-up||||.591
70887742|NCT02188485|141261509|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.52||0.511|TWO_SIDED||||||Mixed Models Analysis||This mean difference is not identical to the mean difference presented in the summary table because this mean difference was adjusted for random effects in the model.|||||.511
70887743|NCT02188485|141261510|SUPERIORITY||Mean Difference (Final Values)|-2.47|STANDARD_ERROR_OF_MEAN|0.85||0.014|TWO_SIDED||||||Mixed Models Analysis||This mean difference is not identical to the mean difference presented in the summary table because this mean difference was adjusted for random effects in the model.|||||.014
70887744|NCT01868633|141261512|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
70887745|NCT02457325|141261517|SUPERIORITY_OR_OTHER_LEGACY|||||||0.192|||||||t-test, 2 sided|||||||0.192
70887746|NCT02457325|141261518|SUPERIORITY_OR_OTHER_LEGACY|||||||0.457|||||||t-test, 2 sided|||||||0.457
70887747|NCT02457325|141261519|SUPERIORITY_OR_OTHER_LEGACY|||||||0.158|||||||t-test, 2 sided|||||||0.158
70887748|NCT02457325|141261520|SUPERIORITY_OR_OTHER_LEGACY|||||||0.953|||||||t-test, 2 sided|||||||0.953
70887749|NCT02457325|141261521|SUPERIORITY_OR_OTHER_LEGACY|||||||0.693|||||||t-test, 2 sided|||||||0.693
70887750|NCT02457325|141261522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.158|||||||t-test, 2 sided|||||||0.158
70887751|NCT02457325|141261523|SUPERIORITY_OR_OTHER_LEGACY|||||||0.192|||||||t-test, 2 sided|||||||0.192
70887752|NCT02457325|141261524|SUPERIORITY_OR_OTHER_LEGACY|||||||0.512|||||||t-test, 2 sided|||||||0.512
70887753|NCT02457325|141261525|SUPERIORITY_OR_OTHER_LEGACY|||||||0.115|||||||t-test, 2 sided|||||||0.115
70887754|NCT02457325|141261526|SUPERIORITY_OR_OTHER_LEGACY|||||||0.73|||||||t-test, 2 sided|||||||0.730
70887755|NCT02457325|141261527|SUPERIORITY_OR_OTHER_LEGACY|||||||0.835|||||||t-test, 2 sided|||||||0.835
70887756|NCT04099524|141261529|SUPERIORITY|The analysis was based on evaluating whether active tDCS is superior than sham tDCS on outcomes.|Mean Difference (Final Values)|-0.18|||<|0.05|TWO_SIDED|||||multiple correction adjusted p\<0.05|Mixed Models Analysis|||p-value was calculated, and is not attempting to indicate the threshold for statistical significance.||||<0.05
70887757|NCT04099524|141261529|SUPERIORITY||Mean Difference (Final Values)|0.2|||<|0.05|TWO_SIDED|||||multiple correction adjusted p\<0.05|Mixed Models Analysis|||||||<0.05
70887758|NCT04099524|141261530|SUPERIORITY|The analysis was based on evaluating whether active tDCS is superior than sham tDCS on outcomes.|chi-square|3.14|||<|0.05|TWO_SIDED||||||Chi-squared|||reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.||||<0.05
70887759|NCT04099524|141261531|SUPERIORITY|The analysis was based on evaluating whether active tDCS is superior than sham tDCS on outcomes.|Mean Difference (Final Values)|0.2|||<|0.05|TWO_SIDED|||||multiple correction adjusted p\<0.05|Mixed Models Analysis|||p-value was calculated, and is not attempting to indicate the threshold for statistical significance.||||<0.05
70887760|NCT04099524|141261532|SUPERIORITY|The analysis was based on evaluating whether active tDCS is superior than sham tDCS on outcomes.|Mean Difference (Final Values)|0.84|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance||||<0.05
70887761|NCT02517905|141261543|SUPERIORITY||LSMD|-2.7||||0.8661|TWO_SIDED|95.0|-33.5|28.2|||ANOVA|||||28.2|-33.5|0.8661
70887762|NCT02517905|141261544|SUPERIORITY||LSMD|-4.0||||0.578|TWO_SIDED|95.0|-18.2|10.2|||ANOVA|||||10.2|-18.2|0.5780
70887763|NCT02517905|141261545|SUPERIORITY||LSMD|5.9||||0.801|TWO_SIDED|95.0|-40.2|52.1|||ANOVA|||||52.1|-40.2|0.8010
70887764|NCT02742103|141261565|OTHER||Rate difference (CSL112 - placebo)|-0.124|||||TWO_SIDED|95.0|-0.296|-0.005|||Newcombe-Wilson|||||-0.005|-0.296|
70887765|NCT02742103|141261566|OTHER||Rate difference (CSL112 - placebo)|-0.103|||||TWO_SIDED|95.0|-0.277|0.025|||Newcombe-Wilson|||||0.025|-0.277|
70887766|NCT00600821|141261582|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.093||||0.639|TWO_SIDED|95.0|0.679|1.761||One-sided log-rank test at alpha = 0.20 significance level was used.|Log Rank|||Differences in PFS between treatment arms was analyzed by 1-sided log rank test, stratified by gender and prior adjuvant therapy.||1.761|0.679|0.639
70887767|NCT00600821|141261583|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.117||||0.699|TWO_SIDED|95.0|0.739|1.689||One-sided log-rank test at alpha = 0.20 significance level was used.|Log Rank|||Differences in OS between treatment arms was analyzed by 1-sided log rank test, stratified by gender and prior adjuvant therapy.||1.689|0.739|0.699
70887768|NCT00600821|141261584|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.676||||0.9422|TWO_SIDED|95.0|0.412|1.107|||Cochran-Mantel-Haenszel|||P-value was calculated using 1-sided Cochran-Mantel-Haenszel test stratified by gender and prior adjuvant therapy. Risk ratio in comparison to the Bevacizumab group was calculated assuming all other factors as constant.||1.107|0.412|0.9422
70887769|NCT00023673|141261613|SUPERIORITY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|2-sided significance level = 0.05||Lung toxicity (\<Grade 3 vs. \>= Grade 3): Lung V20||||0.62
70887770|NCT00023673|141261613|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|2-sided significance level = 0.05||Esophagitis toxicity (\<Grade 2 vs. \>= Grade 2): Lung V20||||0.22
70887771|NCT00023673|141261614|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|2-sided significance level = 0.05||Lung toxicity (\<Grade 3 vs. \>= Grade 3): Mean Lung Dose||||0.30
70887772|NCT00023673|141261614|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|2-sided significance level = 0.05||Esophagitis toxicity (\<Grade 2 vs. \>= Grade 2): Mean Lung Dose||||0.17
70887773|NCT00023673|141261614|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|2-sided significance level = 0.05||Esophagitis toxicity (\<Grade 2 vs. \>= Grade 2): Mean Esophageal Dose||||0.08
70887774|NCT04622254|141261633|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
70887775|NCT04622254|141261634|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
70887776|NCT04622254|141261635|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
70887777|NCT04622254|141261636|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
70887778|NCT04622254|141261637|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
70887779|NCT04622254|141261638|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
70887780|NCT04622254|141261639|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
70887781|NCT04622254|141261640|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
70887782|NCT04622254|141261641|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
70887783|NCT04622254|141261642|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70887784|NCT04622254|141261643|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
70887785|NCT04622254|141261644|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
70887786|NCT04622254|141261645|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
70887787|NCT04622254|141261645|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
70887788|NCT04622254|141261646|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70887789|NCT04622254|141261646|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70887790|NCT03161314|141261691|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||Baseline||||0.660
70887791|NCT03161314|141261691|SUPERIORITY|||||||0.734|||||||t-test, 2 sided|||2 weeks after the intervention||||0.734
70887792|NCT03161314|141261691|SUPERIORITY|||||||0.629|||||||t-test, 2 sided|||4 weeks after the intervention||||0.629
70887793|NCT03161314|141261691|SUPERIORITY|||||||0.752|||||||t-test, 2 sided|||1-month follow-up||||0.752
70887794|NCT03161314|141261691|SUPERIORITY|||||||0.512|||||||t-test, 2 sided|||2-month follow-up||||0.512
70887795|NCT03161314|141261691|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
70887796|NCT03161314|141261691|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
70887797|NCT03161314|141261692|SUPERIORITY|||||||0.128|||||||t-test, 2 sided|||Baseline||||0.128
70887798|NCT03161314|141261692|SUPERIORITY|||||||0.889|||||||t-test, 2 sided|||2 weeks after the intervention||||0.889
70887799|NCT03161314|141261692|SUPERIORITY|||||||0.793|||||||t-test, 2 sided|||4 weeks after the intervention||||0.793
70887800|NCT03161314|141261692|SUPERIORITY|||||||0.602|||||||t-test, 2 sided|||1-month follow-up||||0.602
70887801|NCT03161314|141261692|SUPERIORITY|||||||0.574|||||||t-test, 2 sided|||2-month follow-up||||0.574
70887802|NCT03161314|141261692|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
70887803|NCT03161314|141261692|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
70887804|NCT03161314|141261693|SUPERIORITY|||||||0.374|||||||t-test, 2 sided|||Baseline||||0.374
70887805|NCT03161314|141261693|SUPERIORITY|||||||0.674|||||||t-test, 2 sided|||2 weeks after the intervention||||0.674
70887806|NCT03161314|141261693|SUPERIORITY|||||||0.781|||||||t-test, 2 sided|||4 weeks after the intervention||||0.781
70887807|NCT03161314|141261693|SUPERIORITY|||||||0.778|||||||t-test, 2 sided|||1-month follow-up||||0.778
70887808|NCT03161314|141261693|SUPERIORITY|||||||0.727|||||||t-test, 2 sided|||2-month follow-up||||0.727
70887809|NCT03161314|141261693|SUPERIORITY|||||||0.014|||||||ANOVA|||Within group comparison||||0.014
70887810|NCT03161314|141261693|SUPERIORITY|||||||0.002|||||||ANOVA|||Within group comparison||||0.002
70887811|NCT03161314|141261694|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||Baseline||||0.390
70887812|NCT03161314|141261694|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||2 weeks after the intervention||||0.770
70887813|NCT03161314|141261694|SUPERIORITY|||||||0.603|||||||t-test, 2 sided|||4 weeks after the intervention||||0.603
70887814|NCT03161314|141261694|SUPERIORITY|||||||0.922|||||||t-test, 2 sided|||1-month follow-up||||0.922
70887815|NCT03161314|141261694|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||2-month follow-up||||0.560
70887816|NCT03161314|141261694|SUPERIORITY|||||||0.181|||||||ANOVA|||Within group comparison||||0.181
70887817|NCT03161314|141261694|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
70887818|NCT03161314|141261695|SUPERIORITY|||||||0.334|||||||t-test, 2 sided|||Baseline||||0.334
70887819|NCT03161314|141261695|SUPERIORITY|||||||0.766|||||||t-test, 2 sided|||2 weeks after the intervention||||0.766
70887820|NCT03161314|141261695|SUPERIORITY|||||||0.598|||||||t-test, 2 sided|||4 weeks after the intervention||||0.598
70887821|NCT03161314|141261695|SUPERIORITY|||||||0.682|||||||t-test, 2 sided|||1-month follow-up||||0.682
70887822|NCT03161314|141261695|SUPERIORITY|||||||0.707|||||||t-test, 2 sided|||2-month follow-up||||0.707
70887823|NCT03161314|141261695|SUPERIORITY|||||||0.008|||||||ANOVA|||Within group comparison||||0.008
70887824|NCT03161314|141261695|SUPERIORITY|||||||0.002|||||||ANOVA|||Within group comparison||||0.002
70887825|NCT03161314|141261696|SUPERIORITY|||||||0.287|||||||t-test, 2 sided|||Baseline||||0.287
70887826|NCT03161314|141261696|SUPERIORITY|||||||0.861|||||||t-test, 2 sided|||2 weeks after the intervention||||0.861
70887827|NCT03161314|141261696|SUPERIORITY|||||||0.641|||||||t-test, 2 sided|||4 weeks after the intervention||||0.641
70887828|NCT03161314|141261696|SUPERIORITY|||||||0.864|||||||t-test, 2 sided|||1-month follow-up||||0.864
70887829|NCT03161314|141261696|SUPERIORITY|||||||0.888|||||||t-test, 2 sided|||2-month follow-up||||0.888
70887830|NCT03161314|141261696|SUPERIORITY|||||||0.262|||||||ANOVA|||Within group comparison||||0.262
70887831|NCT03161314|141261696|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
70887832|NCT04304001|141261697|SUPERIORITY||||||<|0.05|||||||Chi-squared|||For each arm, the proportion of participants who receive colorectal cancer screening by 12 months was computed. The chi-square test was used to compare the two treatment arms for screening receipt. If the proportion of participants receiving colorectal cancer screening in the intervention arm is at least 15% higher than that in the control arm, the intervention was determined to be effective.||||<0.05
70887833|NCT04304001|141261698|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||Bivariate analyses was conducted for the knowledge scale to compare differences between the intervention and control arms. Since knowledge was a continuous variable,the values between study arms were compared using two-sample independent t-tests.||||<0.05
70887834|NCT04304001|141261699|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||Bivariate analyses was conducted for the self-efficacy scale to compare differences between the intervention and control arms. Since self-efficacy was a continuous variable, the values between study arms were compared using two-sample independent t-tests.||||<0.05
70887835|NCT02664038|141261715|SUPERIORITY||Mean Difference (Final Values)|-2.82|STANDARD_ERROR_OF_MEAN|2.68|<|0.05|TWO_SIDED|0.05|-8.23|2.588|||ANCOVA|covaried for days of heavy drinking over the 30 days prior to randomization.||||2.588|-8.23|<.05
70887836|NCT02664038|141261716|SUPERIORITY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|1.66|<|0.05|TWO_SIDED|0.05|-3.26|3.61|||ANCOVA|Days of heavy drinking 30 days prior to randomization||||3.61|-3.26|<.05
70887837|NCT02664038|141261717|SUPERIORITY||Mean Difference (Final Values)|2.94|STANDARD_ERROR_OF_MEAN|1.49||0.77|TWO_SIDED|0.05|1.45|4.43|||Mixed Models Analysis|Repeated measure with Baseline, 13 weeks and 26 weeks||||4.43|1.45|.77
70887838|NCT02664038|141261718|SUPERIORITY||Mean Difference (Final Values)|1.44|STANDARD_ERROR_OF_MEAN|1.53|<|0.05|TWO_SIDED|95.0|-1.61|4.5|||Mixed Models Analysis|||||4.50|-1.61|<.05
70887839|NCT02664038|141261719|SUPERIORITY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.43||0.05|TWO_SIDED|0.05|0.19|1.11|||t-test, 2 sided|||||1.11|.19|.05
70887840|NCT05421078|141261720|SUPERIORITY||Least Squares (LS) Means|-25.84|STANDARD_ERROR_OF_MEAN|5.387|<|0.0001|TWO_SIDED|95.0|-36.53|-15.14||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-15.14|-36.53|<.0001
70887841|NCT05421078|141261720|SUPERIORITY||Least Squares (LS) Means|-33.34|STANDARD_ERROR_OF_MEAN|5.378|<|0.0001|TWO_SIDED|95.0|-44.01|-22.66||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-22.66|-44.01|<.0001
70887842|NCT05421078|141261720|SUPERIORITY||Least Squares (LS) Means|-36.12|STANDARD_ERROR_OF_MEAN|5.323|<|0.0001|TWO_SIDED|95.0|-46.68|-25.55||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-25.55|-46.68|<.0001
70887843|NCT05421078|141261721|SUPERIORITY||Least Squares (LS) Means|-25.84|STANDARD_ERROR_OF_MEAN|5.387|<|0.0001|TWO_SIDED|95.0|-36.53|-15.14|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||p value is calculated||-15.14|-36.53|<.0001
70887844|NCT05421078|141261721|SUPERIORITY||Least Squares (LS) Means|-33.34|STANDARD_ERROR_OF_MEAN|5.378|<|0.0001|TWO_SIDED|95.0|-44.01|-22.66||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-22.66|-44.01|<.0001
70887845|NCT05421078|141261721|SUPERIORITY||Least Squares (LS) Means|-36.12|STANDARD_ERROR_OF_MEAN|5.323|<|0.0001|TWO_SIDED|95.0|-46.68|-25.55||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-25.55|-46.68|<.0001
70887846|NCT05421078|141261722|SUPERIORITY||Least Squares (LS) Means|-25.84|STANDARD_ERROR_OF_MEAN|5.387|<|0.0001|TWO_SIDED|95.0|-36.53|-15.14||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-15.14|-36.53|<.0001
70887847|NCT05421078|141261722|SUPERIORITY||Least Squares (LS) Means|-33.34|STANDARD_ERROR_OF_MEAN|5.378|<|0.0001|TWO_SIDED|95.0|-44.01|-22.66||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-22.66|-44.01|<.0001
70887848|NCT05421078|141261722|SUPERIORITY||Least Squares (LS) Means|-36.12|STANDARD_ERROR_OF_MEAN|5.323|<|0.0001|TWO_SIDED|95.0|-46.68|-25.55||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-25.55|-46.68|<.0001
70887849|NCT05421078|141261723|SUPERIORITY||Least Squares (LS) Means|-27.2|STANDARD_ERROR_OF_MEAN|5.626|<|0.0001|TWO_SIDED|95.0|-38.37|-16.04||p value is calculated|ANCOVA|||||-16.04|-38.37|<.0001
70887850|NCT05421078|141261723|SUPERIORITY||Least Squares (LS) Means|-31.23|STANDARD_ERROR_OF_MEAN|5.609|<|0.0001|TWO_SIDED|95.0|-42.36|-20.1||p value is calculated|ANCOVA|||||-20.10|-42.36|<.0001
70887851|NCT05421078|141261723|SUPERIORITY||Least Squares (LS) Means|-36.81|STANDARD_ERROR_OF_MEAN|5.55|<|0.0001|TWO_SIDED|95.0|-47.83|-25.8||p value is calculated|ANCOVA|||||-25.80|-47.83|<.0001
70887852|NCT05421078|141261724|SUPERIORITY||Least Squares (LS) Means|-27.2|STANDARD_ERROR_OF_MEAN|5.626|<|0.0001|TWO_SIDED|95.0|-38.37|-16.04||p value is calculated|ANCOVA|||||-16.04|-38.37|<.0001
70887853|NCT05421078|141261724|SUPERIORITY||Least Squares (LS) Means|-31.23|STANDARD_ERROR_OF_MEAN|5.609|<|0.0001|TWO_SIDED|95.0|-42.36|-20.1||p value is calculated|ANCOVA|||||-20.10|-42.36|<.0001
70887854|NCT05421078|141261724|SUPERIORITY||Least Squares (LS) Means|-36.81|STANDARD_ERROR_OF_MEAN|5.55|<|0.0001|TWO_SIDED|95.0|-47.83|-25.8||p value is calculated|ANCOVA|||||-25.80|-47.83|<.0001
70887855|NCT05421078|141261725|SUPERIORITY||Least Squares (LS) Means|-27.2|STANDARD_ERROR_OF_MEAN|5.626|<|0.0001|TWO_SIDED|95.0|-38.37|-16.04||p value is calculated|ANCOVA|||||-16.04|-38.37|<.0001
70887856|NCT05421078|141261725|SUPERIORITY||Least Squares (LS) Means|-31.23|STANDARD_ERROR_OF_MEAN|5.609|<|0.0001|TWO_SIDED|95.0|-42.36|-20.1||p value is calculated|ANCOVA|||||-20.10|-42.36|<.0001
70887857|NCT05421078|141261725|SUPERIORITY||Least Squares (LS) Means|-36.81|STANDARD_ERROR_OF_MEAN|5.55|<|0.0001|TWO_SIDED|95.0|-47.83|-25.8||p value is calculated|ANCOVA|||||-25.80|-47.83|<.0001
70887858|NCT05421078|141261726|SUPERIORITY||Least Squares (LS) Means|-19.0|STANDARD_ERROR_OF_MEAN|3.439|<|0.0001|TWO_SIDED|95.0|-25.83|-12.18||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-12.18|-25.83|<.0001
70887859|NCT05421078|141261726|SUPERIORITY||Least Squares (LS) Means|-22.45|STANDARD_ERROR_OF_MEAN|3.441|<|0.0001|TWO_SIDED|95.0|-29.28|-15.62||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-15.62|-29.28|<.0001
70887860|NCT05421078|141261726|SUPERIORITY||Least Squares (LS) Means|-24.86|STANDARD_ERROR_OF_MEAN|3.406|<|0.0001|TWO_SIDED|95.0|-31.62|-18.1||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-18.10|-31.62|<.0001
70887861|NCT05421078|141261727|SUPERIORITY||Least Squares (LS) Means|-19.0|STANDARD_ERROR_OF_MEAN|3.439|<|0.0001|TWO_SIDED|95.0|-25.83|-12.18||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-12.18|-25.83|<.0001
70887862|NCT05421078|141261727|SUPERIORITY||Least Squares (LS) Means|-22.45|STANDARD_ERROR_OF_MEAN|3.441|<|0.0001|TWO_SIDED|95.0|-29.28|-15.62||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-15.62|-29.28|<.0001
70887863|NCT05421078|141261727|SUPERIORITY||Least Squares (LS) Means|-24.86|STANDARD_ERROR_OF_MEAN|3.406|<|0.0001|TWO_SIDED|95.0|-31.62|-18.1||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-18.10|-31.62|<.0001
70887864|NCT05421078|141261728|SUPERIORITY||Least Squares (LS) Means|-19.0|STANDARD_ERROR_OF_MEAN|3.439|<|0.0001|TWO_SIDED|95.0|-25.83|-12.18||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-12.18|-25.83|<.0001
70887865|NCT05421078|141261728|SUPERIORITY||Least Squares (LS) Means|-22.45|STANDARD_ERROR_OF_MEAN|3.441|<|0.0001|TWO_SIDED|95.0|-29.28|-15.62||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-15.62|-29.28|<.0001
70887866|NCT05421078|141261728|SUPERIORITY||Least Squares (LS) Means|-24.86|STANDARD_ERROR_OF_MEAN|3.406|<|0.0001|TWO_SIDED|95.0|-31.62|-18.1||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-18.10|-31.62|<.0001
70887867|NCT05421078|141261729|SUPERIORITY||Least Squares (LS) Means|-23.94|STANDARD_ERROR_OF_MEAN|4.85|<|0.0001|TWO_SIDED|95.0|-33.56|-14.31||p value is calculated|Mixed Models Analysis|||||-14.31|-33.56|<.0001
70887868|NCT05421078|141261729|SUPERIORITY||Least Squares (LS) Means|-28.39|STANDARD_ERROR_OF_MEAN|4.849|<|0.0001|TWO_SIDED|95.0|-38.01|-18.76||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-18.76|-38.01|<.0001
70887869|NCT05421078|141261729|SUPERIORITY||Least Squares (LS) Means|-28.55|STANDARD_ERROR_OF_MEAN|4.801|<|0.0001|TWO_SIDED|95.0|-38.08|-19.03||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-19.03|-38.08|<.0001
70887870|NCT05421078|141261730|SUPERIORITY||Least Squares (LS) Means|-23.94|STANDARD_ERROR_OF_MEAN|4.85|<|0.0001|TWO_SIDED|95.0|-33.56|-14.31||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.31|-33.56|<.0001
70887871|NCT05421078|141261730|SUPERIORITY||Least Squares (LS) Means|-28.39|STANDARD_ERROR_OF_MEAN|4.849|<|0.0001|TWO_SIDED|95.0|-38.01|-18.76||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-18.76|-38.01|<.0001
70887872|NCT05421078|141261730|SUPERIORITY||Least Squares (LS) Means|-28.55|STANDARD_ERROR_OF_MEAN|4.801|<|0.0001|TWO_SIDED|95.0|-38.08|-19.03||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-19.03|-38.08|<.0001
70887873|NCT05421078|141261731|SUPERIORITY||Least Squares (LS) Means|-23.94|STANDARD_ERROR_OF_MEAN|4.85|<|0.0001|TWO_SIDED|95.0|-33.56|-14.31||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.31|-33.56|<.0001
70887874|NCT05421078|141261731|SUPERIORITY||Least Squares (LS) Means|-28.39|STANDARD_ERROR_OF_MEAN|4.849|<|0.0001|TWO_SIDED|95.0|-38.01|-18.76||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-18.76|-38.01|<.0001
70887875|NCT05421078|141261731|SUPERIORITY||Least Squares (LS) Means|-28.55|STANDARD_ERROR_OF_MEAN|4.801|<|0.0001|TWO_SIDED|95.0|-38.08|-19.03||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-19.03|-38.08|<.0001
70887876|NCT05421078|141261732|SUPERIORITY||Least Squares (LS) Means|133.11|STANDARD_ERROR_OF_MEAN|10.205|<|0.0001|TWO_SIDED|95.0|112.85|153.36||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||153.36|112.85|<.0001
70887877|NCT05421078|141261732|SUPERIORITY||Least Squares (LS) Means|147.41|STANDARD_ERROR_OF_MEAN|10.195|<|0.0001|TWO_SIDED|95.0|127.17|167.64||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||167.64|127.17|<.0001
70887878|NCT05421078|141261732|SUPERIORITY||Least Squares (LS) Means|155.98|STANDARD_ERROR_OF_MEAN|10.1|<|0.0001|TWO_SIDED|95.0|135.93|176.02||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||176.02|135.93|<.0001
70887879|NCT05421078|141261733|SUPERIORITY||Least Squares (LS) Means|133.11|STANDARD_ERROR_OF_MEAN|10.205|<|0.0001|TWO_SIDED|95.0|112.85|153.36||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||153.36|112.85|<.0001
70887880|NCT05421078|141261733|SUPERIORITY||Least Squares (LS) Means|147.41|STANDARD_ERROR_OF_MEAN|10.195|<|0.0001|TWO_SIDED|95.0|127.17|167.64||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||167.64|127.17|<.0001
70887881|NCT05421078|141261733|SUPERIORITY||Least Squares (LS) Means|155.98|STANDARD_ERROR_OF_MEAN|10.1|<|0.0001|TWO_SIDED|95.0|135.93|176.02||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||176.02|135.93|<.0001
70887882|NCT05421078|141261734|SUPERIORITY||Least Squares (LS) Means|133.11|STANDARD_ERROR_OF_MEAN|10.205|<|0.0001|TWO_SIDED|95.0|112.85|153.36||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||153.36|112.85|<.0001
70887883|NCT05421078|141261734|SUPERIORITY||Least Squares (LS) Means|147.41|STANDARD_ERROR_OF_MEAN|10.195|<|0.0001|TWO_SIDED|95.0|127.17|167.64||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||167.64|127.17|<.0001
70887884|NCT05421078|141261734|SUPERIORITY||Least Squares (LS) Means|155.98|STANDARD_ERROR_OF_MEAN|10.1|<|0.0001|TWO_SIDED|95.0|135.93|176.02||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||176.02|135.93|<.0001
70887885|NCT04456699|141261765|SUPERIORITY||Hazard Ratio (HR)|1.41||||0.9774|TWO_SIDED|95.0|1.0|1.97|||Log Rank|One-sided p-value based on log-rank test stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|||1.97|1.00|0.9774
70887886|NCT04456699|141261765|SUPERIORITY||Hazard Ratio (HR)|1.75||||0.9993|TWO_SIDED|95.0|1.23|2.49|||Log Rank|One-sided p-value based on log-rank test stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|||2.49|1.23|0.9993
70887887|NCT04456699|141261766|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.1527|TWO_SIDED|95.0|0.54|1.21|||Log Rank|One-sided p-value based on log-rank test stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|||1.21|0.54|0.1527
70887888|NCT04456699|141261766|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.2491|TWO_SIDED|95.0|0.59|1.3|||Log Rank|One-sided p-value based on log-rank test stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|||1.30|0.59|0.2491
70887889|NCT04456699|141261767|SUPERIORITY||Difference in Percentage|-0.2||||0.5272|TWO_SIDED|95.0|-7.0|6.5|||Miettinen and Nurminen|Based on stratified Miettinen \& Nurminen method. One-sided p-value for testing H0: difference in % = 0 versus H1: difference in % \> 0.|Based on Miettinen \& Nurminen method stratified by prior FOLFOX/CAPOX + Bev induction response, cycles and mutation status.|||6.5|-7.0|0.5272
70887890|NCT04456699|141261767|SUPERIORITY||Difference in Percentage|-3.2||||0.902|TWO_SIDED|95.0|-9.7|2.3|||Miettinen & Nurminen|Based on stratified Miettinen \& Nurminen method. One-sided p-value for testing H0: difference in % = 0 versus H1: difference in % \> 0.|Based on Miettinen \& Nurminen method stratified by prior FOLFOX/CAPOX + Bev induction response, cycles and mutation status.|||2.3|-9.7|0.9020
70887891|NCT02915029|141261795|SUPERIORITY|The primary hypothesis being tested was that the intervention will increase patient activation.|Mean Difference (Net)|8.7||||0.01|TWO_SIDED|95.0|1.9|15.5|||ANCOVA|Primary outcome was change in PAM total score, adjusted for baseline level. Adjusting for family clustering with generalized estimated equations.|This reflects the between-group difference for the within-person change scores in PAM total score adjusting for baseline values per person.|Group 1(usual care) is the comparison group, group 2 is the intervention group.|Applied generalized estimating equations (GEE) to account for within family (household) clustering.|15.5|1.9|0.01
70887892|NCT04452188|141261815|EQUIVALENCE|Prior studies suggest a 25-50% reduction in oxidative stress in normoxia relative to supra-physiologic oxygen. A 20% difference was considered clinically meaningful, and a sample size of 42 total participants was anticipated to achieve at least 80% power with a two-sided 5% significance level. However, an interim analysis recommended by the DSMB after enrollment of 29 patients revealed a significant difference in the primary outcome between the groups, and enrollment was thus stopped.|||||<|0.01||||||To provide a more conservative estimate of significance, the Hochberg sequential procedure was used for adjustment of multiple comparisons in the serum biomarker data including the primary outcome.|t-test, 2 sided|||Each participant's post-operative samples were normalized to their baseline sample and described as a fold-of-change from baseline.||||<0.01
70887893|NCT04452188|141261817|OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the post-operative length of stay between the two groups.||||0.66
70887894|NCT04452188|141261818|OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the days alive and out of ICU at 30 days since surgery between the two groups||||0.66
70887895|NCT04452188|141261819|OTHER|||||||1|||||||Fisher Exact|||||||1.00
70887896|NCT04452188|141261820|OTHER|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||||||0.49
70887897|NCT04452188|141261821|OTHER||||||<|0.01||||||To provide a more conservative estimate of significance, the Hochberg sequential procedure was used for adjustment of multiple comparisons in the serum biomarker data including the primary outcome.|t-test, 2 sided|||||||<0.01
70887898|NCT04452188|141261822|OTHER||||||<|0.01||||||To provide a more conservative estimate of significance, the Hochberg sequential procedure was used for adjustment of multiple comparisons in the serum biomarker data including the primary outcome.|t-test, 2 sided|||||||<0.01
70887899|NCT04452188|141261823|OTHER||||||<|0.1||||||To provide a more conservative estimate of significance, the Hochberg sequential procedure was used for adjustment of multiple comparisons in the serum biomarker data including the primary outcome.|t-test, 2 sided|||||||<0.1
70887900|NCT02357576|141261825|OTHER|Percentage and frequencies were used to describe the incidence of PNAC in the two groups.||||||0.617|||||||Fisher Exact|||||||0.617
70887901|NCT02357576|141261826|OTHER|Percentage and frequencies were used to describe the incidence of severe PNAC.||||||0.45|||||||Fisher Exact|||||||0.450
70887902|NCT02357576|141261827|OTHER|The Kaplan Meier curve was used to evaluated the time to first PNAC event.||||||0.2716|||||||Log Rank|A log rank test was used to test the equality of the survival curve between the two groups.||||||0.2716
70887903|NCT00128180|141261844|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Fisher Exact|||||||0.18
70887904|NCT03296163|141261858|EQUIVALENCE|"Equivalence analysis was based on the risk ratio (RR) (MB02/EU-approved Avastin) with an equivalence margin predefined \[0.73, 1.36\].~The ORR estimate was stratified using the Cochran-Mantel-Haenszel estimate of the RR and corresponding 2-sided 90% confidence interval (CI)."|Risk Ratio (RR)|0.91|||||TWO_SIDED|90.0|0.78|1.06|||||Direction of comparison is: For RR: MB02/EU-approved Avastin. 95% CI was also calculated: (0.758, 1.092)|||1.060|0.780|
70887905|NCT03296163|141261858|EQUIVALENCE|The ORR estimate was stratified using the Cochran-Mantel-Haenszel estimate of the risk difference (RD) (MB02-EU-approved Avastin) with an equivalence margin predefined \[-12%, 12%\] and corresponding 2-sided 95% CI.|Risk Difference (RD)|-4.02|||||TWO_SIDED|90.0|-10.51|2.47|||||Direction of comparison is: For RD: MB02 - EU-approved Avastin. 95% CI was also calculated: (-11.76, 3.71)|||2.47|-10.51|
70887906|NCT03296163|141261859|OTHER|Hazard ratio of MB02 versus EU-approved Avastin; a hazard ratio =1 indicated no difference in progressive disease(PD)/death between 2 reporting groups; \>1 indicated an increase in PD/death in MB02; \<1 indicated an increase in PD/death in EU-approved Avastin.|Hazard Ratio (HR)|1.187|||||TWO_SIDED|95.0|0.98|1.44||||||||1.44|0.98|
70887907|NCT03296163|141261860|OTHER||Hazard Ratio (HR)|1.108|||||TWO_SIDED|95.0|0.827|1.485||||||||1.485|0.827|
70887908|NCT00414050|141261865|NON_INFERIORITY_OR_EQUIVALENCE|Modified Process Hepatitis B vaccine-5µg (micrograms) declared non-inferior to RECOMBIVAX HB™ if the lower bound of the 95% Confidence Interval for the ratio of Geometric Mean Titers (Modified Process Vaccine 5 micrograms/RECOMBIVAX HB™) was \>= 0.67. The study had 98 percent power for this test, based on an assumption of true equality.|Ratio of geometric means|1.99|||||TWO_SIDED|95.0|1.69|2.35||||||Comparison of Induced (effected) Geometric Mean Titer for the Modified Hepatitis B Process Vaccine and RECOMBIVAX Hepatitis B vaccine.||2.35|1.69|
70887909|NCT03495908|141261866|NON_INFERIORITY|Non-inferiority margin is 0.4% HbA1c|Mean Difference (Net)|-0.2207||||0.007|TWO_SIDED|95.0|-0.6654|0.2241||Non-inferiority p-value based on the 0.4% non-inferiority margin|Mixed Models Analysis||RHI - RAI estimated treatment difference. Upper confidence interval 0.22 is less than the 0.4% non-inferiority margin.|RHI - RAI estimated treatment difference (ETD) in HbA1c. Per-protocol analysis is the pre-specified primary outcome.||0.2241|-0.6654|0.007
70887910|NCT03495908|141261867|SUPERIORITY|Comparison of Post-randomization prevalence of hypoglycemia based on 7-point glucose profiles.||||||0.82|||||||Fisher Exact|||Post-randomization prevalence of hypoglycemia based on 7-point glucose profiles.||||.82
70887911|NCT03495908|141261868|SUPERIORITY|Analysis of the 7-point profiles within the ITT population (n=136)|Risk Ratio (RR)|0.925||||0.861|TWO_SIDED|95.0|0.386|2.217||Results are from a Poisson regression model with repeated measures; generalized estimating equations (GEE) approach.|Regression, Poisson|Poisson regression model with repeated measures; generalized estimating equations (GEE) approach|The incidence rate ratio quantitates the risk of hypoglycemia in the RHI group (RR numerator) compared with the RAI group (RR numerator). Results from Poisson regression model with repeated measures; generalized estimating equations (GEE) approach.|Level 1 (≤70 mg/dL or (\<3.9 mmol/L)) and level 2 hypoglycemia (\<54 mg/dL (\<3.0 mmol/L)) events are analyzed. No level 3 events were reported for either group.||2.217|0.386|0.861
70887912|NCT03495908|141261869|SUPERIORITY||Mean Difference (Net)|-0.01073||||0.415|TWO_SIDED|95.0|-0.03674|0.01528|||Mixed Models Analysis||Between Group Comparison (RHI-RAI) Estimated Treatment Difference (ETD) mixed effects model analysis|RHI versus RAI for Insulin Intent-to-treat Population N=136 Mixed Model Estimates for Insulin TDD U/kg I||0.01528|-0.03674|0.415
70887913|NCT03495908|141261870|SUPERIORITY||Mean Difference (Net)|-1.0776||||0.32|TWO_SIDED|95.0|-3.2139|1.0587|||Mixed Models Analysis||Between Group Comparison (RHI-RAI) Estimated Treatment Difference (ETD) mixed effects model analysis|||1.0587|-3.2139|0.320
70887914|NCT03495908|141261871|SUPERIORITY||Mean Difference (Net)|-265.85|||<|0.0001|TWO_SIDED|95.0|-288.6|-243.11|||Mixed Models Analysis||Estimated Treatment Difference (RHI-RAI) from repeated measures mixed model least squares estimates|||-243.11|-288.60|<0.0001
70887915|NCT03495908|141261872|NON_INFERIORITY|Change in A1C Non-inferiority Margin is 0.4%|Mean Difference (Net)|-0.1317||||0.02|TWO_SIDED|95.0|-0.5838|0.3205||p-value for non-inferiority|Mixed Models Analysis||Between Group Difference (RHI-RAI) mixed effects repeated measures model analysis.Upper confidence interval 0.32 is less than the 0.4% non-inferiority margin.|Intent-to-treat secondary outcome of HbA1c response for assessment of non-inferiority of RHI compared to RAI||0.3205|-0.5838|0.02
70887916|NCT00780572|141261896|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9396||||0.668|TWO_SIDED|95.0|0.7068|1.249|||Regression, Cox|||||1.2490|0.7068|0.6680
70887917|NCT01469065|141261897|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|84.87|||||TWO_SIDED|90.0|78.16|92.15||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test. Formal statistical inference was not performed thus p value was not reported.||92.15|78.16|
70887918|NCT01469065|141261897|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|89.8|||||TWO_SIDED|90.0|82.69|97.53||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||97.53|82.69|
70887919|NCT01469065|141261897|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|87.15|||||TWO_SIDED|90.0|80.27|94.63||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||94.63|80.27|
70887920|NCT01469065|141261897|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|78.28|||||TWO_SIDED|90.0|72.06|85.03||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||85.03|72.06|
70887921|NCT01469065|141261910|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|82.69|||||TWO_SIDED|90.0|76.06|89.9||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 13) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||89.90|76.06|
70887922|NCT01469065|141261910|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|85.39|||||TWO_SIDED|90.0|78.6|92.77||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 13) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||92.77|78.60|
70887923|NCT01469065|141261910|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|85.37|||||TWO_SIDED|90.0|78.59|92.76||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 13) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||92.76|78.59|
70887924|NCT01469065|141261910|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|75.82|||||TWO_SIDED|90.0|69.78|82.39||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 13) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||82.39|69.78|
70887925|NCT01469065|141261910|SUPERIORITY_OR_OTHER||Difference between Test and Reference|-35.84|||||TWO_SIDED|90.0|-52.89|-18.78||||||Treatment difference and 90% confidence interval (CI) were based on adjusted geometric mean.||-18.78|-52.89|
70887926|NCT01469065|141261911|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|86.72|||||TWO_SIDED|90.0|81.13|92.7||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Glucose AUC(2-6) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||92.70|81.13|
70887927|NCT01469065|141261911|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|91.13|||||TWO_SIDED|90.0|85.24|97.44||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Glucose AUC(2-6) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||97.44|85.24|
70887928|NCT01469065|141261911|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|87.05|||||TWO_SIDED|90.0|81.44|93.04||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Glucose AUC(2-6) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||93.04|81.44|
70887929|NCT01469065|141261911|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|77.95|||||TWO_SIDED|90.0|72.91|83.34||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Glucose AUC(2-6) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||83.34|72.91|
70887930|NCT01469065|141261912|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 2|100.04|||||TWO_SIDED|90.0|92.7|107.96||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 2 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||107.96|92.70|
70887931|NCT01469065|141261912|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 2|99.44|||||TWO_SIDED|90.0|92.04|107.43||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 2 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||107.43|92.04|
70887932|NCT01469065|141261912|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 2|101.67|||||TWO_SIDED|90.0|94.1|109.84||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 2 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||109.84|94.10|
70887933|NCT01469065|141261912|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 2|96.82|||||TWO_SIDED|90.0|89.69|104.52||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 2 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||104.52|89.69|
70887934|NCT01469065|141261912|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 3|95.85|||||TWO_SIDED|90.0|88.82|103.44||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 3 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||103.44|88.82|
70887935|NCT01469065|141261912|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 3|98.71|||||TWO_SIDED|90.0|91.37|106.64||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 3 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||106.64|91.37|
70887936|NCT01469065|141261912|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 3|99.72|||||TWO_SIDED|90.0|92.3|107.73||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 3 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||107.73|92.30|
70887937|NCT01469065|141261912|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 3|94.49|||||TWO_SIDED|90.0|87.53|102.1||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 3 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||102.10|87.53|
70887938|NCT01469065|141261912|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 6|93.43|||||TWO_SIDED|90.0|86.5|100.91||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 6 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||100.91|86.50|
70887939|NCT01469065|141261912|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 6|92.71|||||TWO_SIDED|90.0|85.81|100.15||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 6 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||100.15|85.81|
70887940|NCT01469065|141261912|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 6|94.08|||||TWO_SIDED|90.0|87.08|101.64||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 6 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||101.64|87.08|
70887941|NCT01469065|141261912|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 6|87.74|||||TWO_SIDED|90.0|81.2|94.81||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 6 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||94.81|81.20|
70887942|NCT01469065|141261912|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 10|96.91|||||TWO_SIDED|90.0|89.72|104.67||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 10 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||104.67|89.72|
70887943|NCT01469065|141261912|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 10|96.05|||||TWO_SIDED|90.0|88.9|103.76||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 10 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||103.76|88.90|
70887944|NCT01469065|141261912|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 10|99.63|||||TWO_SIDED|90.0|92.21|107.64||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 10 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||107.64|92.21|
70887945|NCT01469065|141261912|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 10|94.5|||||TWO_SIDED|90.0|87.46|102.11||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 10 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||102.11|87.46|
70887946|NCT01469065|141261912|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 14|86.75|||||TWO_SIDED|90.0|80.32|93.69||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 14 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||93.69|80.32|
70887947|NCT01469065|141261912|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 14|87.87|||||TWO_SIDED|90.0|81.34|94.93||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 14 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||94.93|81.34|
70887948|NCT01469065|141261912|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 14|91.35|||||TWO_SIDED|90.0|84.55|98.7||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 14 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||98.70|84.55|
70887949|NCT01469065|141261912|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 14|88.6|||||TWO_SIDED|90.0|82.0|95.74||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 14 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||95.74|82.00|
70887950|NCT01469065|141261912|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 15|90.45|||||TWO_SIDED|90.0|83.75|97.69||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 15 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||97.69|83.75|
70887951|NCT01469065|141261912|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 15|90.45|||||TWO_SIDED|90.0|84.03|98.08||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 15 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||98.08|84.03|
70887952|NCT01469065|141261912|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 15|94.75|||||TWO_SIDED|90.0|87.69|102.34||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 15 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||102.34|87.69|
70887953|NCT01469065|141261912|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 15|93.18|||||TWO_SIDED|90.0|86.17|100.77||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 15 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||100.77|86.17|
70887954|NCT01469065|141261913|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|112.83|||||TWO_SIDED|90.0|99.84|127.5||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Insulin AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||127.50|99.84|
70887955|NCT01469065|141261913|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|102.11|||||TWO_SIDED|90.0|90.78|114.85||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Insulin AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||114.85|90.78|
70887956|NCT01469065|141261913|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|111.04|||||TWO_SIDED|90.0|98.5|125.18||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Insulin AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||125.18|98.50|
70887957|NCT01469065|141261913|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|96.73|||||TWO_SIDED|90.0|85.46|109.48||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Insulin AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||109.48|85.46|
70887958|NCT01469065|141261914|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|107.13|||||TWO_SIDED|90.0|98.69|116.3||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in C-peptide AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||116.30|98.69|
70887959|NCT01469065|141261914|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|92.57|||||TWO_SIDED|90.0|85.26|100.5||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in C-peptide AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||100.50|85.26|
70887960|NCT01469065|141261914|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|96.07|||||TWO_SIDED|90.0|88.51|104.27||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in C-peptide AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||104.27|88.51|
70887961|NCT01469065|141261914|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|91.7|||||TWO_SIDED|90.0|84.38|99.65||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in C-peptide AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||99.65|84.38|
70887962|NCT02203591|141261928|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
70887963|NCT02203591|141261928|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
70887964|NCT02203591|141261928|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
70887965|NCT02203591|141261928|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
70887966|NCT02203591|141261928|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
70887967|NCT02203591|141261928|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
70887968|NCT02203591|141261928|OTHER|95% confidence interval generation|Mean value|81.1|||||TWO_SIDED|95.0|75.6|86.6||||||||86.6|75.6|
70887969|NCT02203591|141261928|OTHER|95% confidence interval generation|Mean value|81.7|||||TWO_SIDED|95.0|76.3|87.1||||||||87.1|76.3|
70887970|NCT02203591|141261928|OTHER|95% confidence interval generation|Mean value|83.2|||||TWO_SIDED|95.0|77.9|88.4||||||||88.4|77.9|
70887971|NCT02203591|141261928|OTHER|95% confidence interval generation|Mean value|38.9|||||TWO_SIDED|95.0|32.3|45.6||||||||45.6|32.3|
70887972|NCT02203591|141261928|OTHER|95% confidence interval generation|Mean value|46.9|||||TWO_SIDED|95.0|40.1|53.7||||||||53.7|40.1|
70887973|NCT02203591|141261928|OTHER|95% confidence interval generation|Mean value|53.0|||||TWO_SIDED|95.0|46.3|59.6||||||||59.6|46.3|
70887974|NCT02203591|141261929|NON_INFERIORITY|A non-inferior margin of 0.5 log10/cm\^2|Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.57|-0.1|||||3M CHG/IPA C - Inguinal minus ChloraPrep - Inguinal|||-0.10|-0.57|
70887975|NCT02203591|141261929|NON_INFERIORITY|A non-inferior margin of 0.5 log10/cm\^2|Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|97.5|-0.44|0.74|||||3M CHG/IPA CH - Inguinal minus ChloraPrep - Inguinal|Since there are two investigational products a Hochberg step-up procedure was used to adjust for multiplicity.||0.74|-0.44|
70887976|NCT02203591|141261930|OTHER|Calculate mean value|Mean value|2.83|STANDARD_DEVIATION|0.85|||TWO_SIDED|||||||||||||
70887977|NCT02203591|141261930|OTHER|Calculate mean value|Mean value|2.86|STANDARD_DEVIATION|0.9|||TWO_SIDED|||||||||||||
70887978|NCT02203591|141261930|OTHER|Calculate mean value|Mean value|2.83|STANDARD_DEVIATION|0.97|||TWO_SIDED|||||||||||||
70887979|NCT02203591|141261930|OTHER|Calculate mean value|Mean value|1.0|STANDARD_DEVIATION|0.97|||TWO_SIDED|||||||||||||
70887980|NCT02203591|141261930|OTHER|Calculate mean value|Mean value|3.46|STANDARD_DEVIATION|1.31|||TWO_SIDED|||||||||||||
70887981|NCT02203591|141261930|OTHER|Calculate mean value|Mean value|3.49|STANDARD_DEVIATION|1.33|||TWO_SIDED|||||||||||||
70887982|NCT02203591|141261930|OTHER|Calculate mean value|Mean value|3.69|STANDARD_DEVIATION|1.29|||TWO_SIDED|||||||||||||
70887983|NCT02203591|141261930|OTHER|Calculate mean value|Mean value|1.23|STANDARD_DEVIATION|0.73|||TWO_SIDED|||||||||||||
70887984|NCT02203591|141261931|OTHER|Calculate mean value|Mean value|2.78|STANDARD_DEVIATION|0.94|||TWO_SIDED|||||||||||||
70887985|NCT02203591|141261931|OTHER|Calculate mean value|Mean value|2.73|STANDARD_DEVIATION|1.0|||TWO_SIDED|||||||||||||
70887986|NCT02203591|141261931|OTHER|Calculate mean value|Mean value|2.75|STANDARD_DEVIATION|0.97|||TWO_SIDED|||||||||||||
70887987|NCT02203591|141261931|OTHER|Calculate mean value|Mean value|0.76|STANDARD_DEVIATION|0.81|||TWO_SIDED|||||||||||||
70887988|NCT02203591|141261931|OTHER|Calculate mean value|Mean value|2.84|STANDARD_DEVIATION|1.19|||TWO_SIDED|||||||||||||
70887989|NCT02203591|141261931|OTHER|Calculate mean value|Mean value|2.99|STANDARD_DEVIATION|1.12|||TWO_SIDED|||||||||||||
70887990|NCT02203591|141261931|OTHER|Calculate mean value|Mean value|3.17|STANDARD_DEVIATION|1.24|||TWO_SIDED|||||||||||||
70887991|NCT02203591|141261931|OTHER|Calculate mean value|Mean value|1.01|STANDARD_DEVIATION|0.67|||TWO_SIDED|||||||||||||
70887992|NCT02203591|141261932|OTHER|Calculate mean value|Mean value|0.8|STANDARD_DEVIATION|0.84|||TWO_SIDED|||||||||||||
70887993|NCT02203591|141261932|OTHER|Calculate mean value|Mean value|0.74|STANDARD_DEVIATION|0.79|||TWO_SIDED|||||||||||||
70887994|NCT02203591|141261932|OTHER|Calculate mean value|Mean value|0.81|STANDARD_DEVIATION|0.94|||TWO_SIDED|||||||||||||
70887995|NCT02203591|141261932|OTHER|Calculate mean value|Mean value|2.65|STANDARD_DEVIATION|0.89|||TWO_SIDED|||||||||||||
70887996|NCT02203591|141261932|OTHER|Calculate mean value|Mean value|2.76|STANDARD_DEVIATION|1.2|||TWO_SIDED|||||||||||||
70887997|NCT02203591|141261932|OTHER|Calculate mean value|Mean value|2.73|STANDARD_DEVIATION|1.22|||TWO_SIDED|||||||||||||
70887998|NCT02203591|141261932|OTHER|Calculate mean value|Mean value|2.58|STANDARD_DEVIATION|1.18|||TWO_SIDED|||||||||||||
70887999|NCT02203591|141261932|OTHER|Calculate mean value|Mean value|4.85|STANDARD_DEVIATION|0.75|||TWO_SIDED|||||||||||||
70888000|NCT02203591|141261933|OTHER|Calculate mean value|Mean value|0.85|STANDARD_DEVIATION|0.95|||TWO_SIDED|||||||||||||
70888001|NCT02203591|141261933|OTHER|Calculate mean value|Mean value|0.87|STANDARD_DEVIATION|0.98|||TWO_SIDED|||||||||||||
70888002|NCT02203591|141261933|OTHER|Calculate mean value|Mean value|0.89|STANDARD_DEVIATION|0.94|||TWO_SIDED|||||||||||||
70888003|NCT02203591|141261933|OTHER|Calculate mean value|Mean value|2.88|STANDARD_DEVIATION|0.7|||TWO_SIDED|||||||||||||
70888004|NCT02203591|141261933|OTHER|Calculate mean value|Mean value|3.39|STANDARD_DEVIATION|1.1|||TWO_SIDED|||||||||||||
70888005|NCT02203591|141261933|OTHER|Calculate mean value|Mean value|3.21|STANDARD_DEVIATION|1.04|||TWO_SIDED|||||||||||||
70888006|NCT02203591|141261933|OTHER|Calculate mean value|Mean value|3.08|STANDARD_DEVIATION|1.14|||TWO_SIDED|||||||||||||
70888007|NCT02203591|141261933|OTHER|Calculate mean value|Mean value|5.08|STANDARD_DEVIATION|0.68|||TWO_SIDED|||||||||||||
70888008|NCT02203591|141261934|OTHER|Calculate mean value|Mean value|3.63|STANDARD_DEVIATION|0.46|||TWO_SIDED|||||||||||||
70888009|NCT02203591|141261934|OTHER|Calculate mean value|Mean value|3.61|STANDARD_DEVIATION|0.48|||TWO_SIDED|||||||||||||
70888010|NCT02203591|141261934|OTHER|Calculate mean value|Mean value|3.64|STANDARD_DEVIATION|0.49|||TWO_SIDED|||||||||||||
70888011|NCT02203591|141261934|OTHER|Calculate mean value|Mean value|3.64|STANDARD_DEVIATION|0.53|||TWO_SIDED|||||||||||||
70888012|NCT02203591|141261934|OTHER|Calculate mean value|Mean value|6.23|STANDARD_DEVIATION|0.6|||TWO_SIDED|||||||||||||
70888013|NCT02203591|141261934|OTHER|Calculate mean value|Mean value|6.22|STANDARD_DEVIATION|0.56|||TWO_SIDED|||||||||||||
70888014|NCT02203591|141261934|OTHER|Calculate mean value|Mean value|6.27|STANDARD_DEVIATION|0.62|||TWO_SIDED|||||||||||||
70888015|NCT02203591|141261934|OTHER|Calculate mean value|Mean value|6.09|STANDARD_DEVIATION|0.63|||TWO_SIDED|||||||||||||
70888016|NCT03022617|141261938|SUPERIORITY||Mean Difference (Final Values)|21.5|STANDARD_DEVIATION|10.89||0.05|TWO_SIDED||||||t-test, 2 sided|||||||.05
70888017|NCT01706250|141261946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.29|STANDARD_DEVIATION|32.98||0.6779|||||||t-test, 2 sided|||Percent change for IL count for MAXCLARITY II Vs PROACTIV at Wk 8||||0.6779
70888018|NCT01706250|141261946|SUPERIORITY_OR_OTHER||Median Difference (Net)|7.68|STANDARD_DEVIATION|29.51||0.2847|||||||t-test, 2 sided|||Percent change for NIL count for MAXCLARITY II Vs PROACTIV at Wk 8||||0.2847
70888019|NCT01706250|141261946|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.24|STANDARD_DEVIATION|23.35||0.6894|||||||t-test, 2 sided|||Percent change for TL count for MAXCLARITY II Vs PROACTIV at Wk 8||||0.6894
70888020|NCT01706250|141261947|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.38|STANDARD_DEVIATION|50.1||0.9909|||||||Signed Rank|||Percent change for MAXCLARITY II Vs PROACTIV: IL count, BL to Wk 1 (within group)||||0.9909
70888021|NCT01706250|141261947|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.0|STANDARD_DEVIATION|39.91||0.6671|||||||t-test, 2 sided|||IL count for MAXCLARITY II Vs PROACTIV- BL to Wk 2 (within group)||||0.6671
70888022|NCT01706250|141261947|SUPERIORITY_OR_OTHER||Median Difference (Net)|23.64|STANDARD_DEVIATION|52.05||0.0632|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: IL count, BL to Wk 4 (within group)||||0.0632
70888023|NCT01706250|141261948|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.2|STANDARD_DEVIATION|42.31||0.7385|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: NIL count, BL to Wk 1 (within group)||||0.7385
70888024|NCT01706250|141261948|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.04|STANDARD_DEVIATION|37.77||0.7296|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: NIL count, BL to Wk 2 (within group)||||0.7296
70888025|NCT01706250|141261948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.5|STANDARD_DEVIATION|36.11||0.3774|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: NIL count, BL to Wk 4 (within group)||||0.3774
70888026|NCT01706250|141261949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.02|STANDARD_DEVIATION|29.53||0.7634|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: TL count, BL to Wk 1 (within group)||||0.7634
70888027|NCT01706250|141261949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.75|STANDARD_DEVIATION|29.61||0.4087|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: TL count, BL to Wk 2 (within group)||||0.4087
70888028|NCT01706250|141261949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.0|STANDARD_DEVIATION|25.4||0.2455|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: TL count, BL to Wk 4 (within group)||||0.2455
70888029|NCT01706250|141261950|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05|STANDARD_DEVIATION|0.39||1|||||||Signed Rank|||Change, in ISGA for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||1.0000
70888030|NCT01706250|141261950|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26|STANDARD_DEVIATION|0.56||0.125|||||||Signed Rank|||Change, in ISGA for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||0.1250
70888031|NCT01706250|141261950|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|STANDARD_DEVIATION|0.46||0.625|||||||Signed Rank|||Change, in ISGA for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||0.6250
70888032|NCT01706250|141261950|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.59||1|||||||Signed Rank|||Change, in ISGA for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)||||1.0000
70888033|NCT01706250|141261951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|0.45||1|||||||Signed Rank|||Change, in Erythema for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||1.0000
70888034|NCT01706250|141261951|SUPERIORITY_OR_OTHER||Signed Rank|0.05|STANDARD_DEVIATION|0.23||1|||||||Signed Rank|||Change, in Erythema for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||1.0000
70888035|NCT01706250|141261952|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.22||1|||||||Signed Rank|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||1.00
70888036|NCT01706250|141261952|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.23||1|||||||Signed rank|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||1.0000
70888037|NCT01706250|141261953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|STANDARD_DEVIATION|0.46||1|||||||Signed rank|||Change, in Peeling, for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||1.0000
70888038|NCT01706250|141261954|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15|STANDARD_DEVIATION|0.67||0.5313||95.0|||||Signed Rank|||Change, in Redness for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||0.5313
70888039|NCT01706250|141261954|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.16|STANDARD_DEVIATION|0.6||0.5||95.0|||||Signed Rank|||Change, in Redness for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||0.5000
70888040|NCT01706250|141261954|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_DEVIATION|0.86||0.75|||||||Signed Rank|||Change, in Redness for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||0.7500
70888041|NCT01706250|141261954|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33|STANDARD_DEVIATION|0.84||0.25|||||||Signed rank|||Change, in Redness for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)||||0.2500
70888042|NCT01706250|141261955|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_DEVIATION|0.86||0.2131|||||||Signed Rank)|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||0.2131
70888043|NCT01706250|141261955|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37|STANDARD_DEVIATION|1.16||0.2656||95.0|||||Signed Rank|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||0.2656
70888044|NCT01706250|141261955|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|STANDARD_DEVIATION|0.75||0.2344||95.0|||||Signed Rank|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||0.2344
70888045|NCT01706250|141261955|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22|STANDARD_DEVIATION|0.73||0.3594||95.0|||||Signed Rank|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)||||0.3594
70888046|NCT01706250|141261956|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.32||0.6172|||||||Signed Rank|||Change, in Burning for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||0.6172
70888047|NCT01706250|141261956|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.26|STANDARD_DEVIATION|0.93||0.3984|||||||Signed Rank|||Change, in Burning for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||0.3984
70888048|NCT01706250|141261956|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56|STANDARD_DEVIATION|1.1||0.0781||95.0|||||Signed Rank|||Change, in Burning for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||0.0781
70888049|NCT01706250|141261956|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39|STANDARD_DEVIATION|1.24||0.375||95.0|||||Signed Rank|||Change, in Burning for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)||||0.3750
70888050|NCT01706250|141261957|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0|STANDARD_DEVIATION|0.46||1||95.0|||||[Signed Rank]|||Change, in Itching for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||1.0000
70888051|NCT01706250|141261957|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.32|STANDARD_DEVIATION|0.58||0.0625||95.0|||||Signed Rank|||Change, in Itching for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||0.0625
70888052|NCT01706250|141261957|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|STANDARD_DEVIATION|0.75||0.25||95.0|||||Signed Rank|||Change, in Itching for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||0.2500
70888053|NCT01706250|141261957|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_DEVIATION|0.38||0.25||95.0|||||Signed Rank|||Change, in Itching for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)||||0.2500
70888054|NCT01706250|141261958|SUPERIORITY_OR_OTHER||Signed Rank|0.15|STANDARD_DEVIATION|0.59||0.5||95.0|||||Signed Rank|||Change, in Scaling for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||0.5000
70888055|NCT01706250|141261958|SUPERIORITY_OR_OTHER||Signed Rank|0.11|STANDARD_DEVIATION|0.57||0.75||95.0|||||Signed Rank|||Change, in Scaling for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||0.7500
70888056|NCT01706250|141261958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_DEVIATION|0.62||0.4531||95.0|||||Signed Rank|||Change, in Scaling for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||0.4531
70888057|NCT01706250|141261958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_DEVIATION|0.86||0.625||95.0|||||Signed Rank|||Change, in Scaling for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)||||0.6250
70888058|NCT01227512|141261978|SUPERIORITY_OR_OTHER|||||||0.9495||||||The alpha level was set at 0.05|Generalized Wilcoxon Test|Participants who used rescue therapy within first 7 days of treatment period were censored at time they started the rescue therapy.||||||0.9495
70888059|NCT01227512|141261979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.146||95.0|-0.7|0.11||alpha level was set at 0.05. p-value was derived from an ANCOVA model with treatment and clinical center as factors and baseline value as covariate.|ANCOVA|Includes factors of treatment, study center and covariate baseline.||||0.11|-0.70|0.1460
70888060|NCT01227512|141261980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.315||95.0|-0.57|0.19|||ANCOVA|P-value was derived from an ANCOVA model with treatment and clinical center as factors and baseline value as covariate.||P value corresponds to 24 hours post-dose.||0.19|-0.57|0.3150
70888061|NCT01227512|141261980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.5381||95.0|-0.57|0.3|||ANCOVA|P-value was derived from an ANCOVA model with treatment and clinical center as factors and baseline value as covariate.||P value corresponds to 72 hours post-dose.||0.30|-0.57|0.5381
70888062|NCT01227512|141261981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.2702||95.0|-0.73|0.21||P-value was derived from a Cochran-Mantel-Haenszel (CMH) row mean scores test.|Cochran-Mantel-Haenszel|||||0.21|-0.73|0.2702
70888063|NCT01227512|141261982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.77||||0.0019||95.0|1.43|6.11||P-value was derived from an ANCOVA model with treatment and clinical center as factors and baseline value as covariate.|ANCOVA|||||6.11|1.43|0.0019
70888064|NCT01227512|141261983|SUPERIORITY_OR_OTHER|||||||0.5128||||||p-value was derived from Generalized Wilcoxon test stratified by treatment. Participants who received rescue therapy were censored at the time of receiving rescue therapy.|Generalized Wilcoxon Test|||||||0.5128
70888065|NCT01227512|141261984|SUPERIORITY_OR_OTHER||Relative Risk|1.1||||0.5795||95.0|0.79|1.52||P-value was derived using a CMH test stratified by hyponatremia symptoms severity.|Cochran-Mantel-Haenszel|||||1.52|0.79|0.5795
70888066|NCT01227512|141261985|SUPERIORITY_OR_OTHER||Relative Risk|0.33||||0.1568||95.0|0.07|1.65||p-value was derived using a CMH test stratified by hyponatremia symptoms severity.|Cochran-Mantel-Haenszel|||||1.65|0.07|0.1568
70888067|NCT04497987|141261986|SUPERIORITY||Odds Ratio (OR)|0.4|||<|0.001|TWO_SIDED|95.0|0.26|0.63|||Regression, Logistic|||||0.63|0.26|<0.001
70888068|NCT04497987|141261987|SUPERIORITY||Odds Ratio (OR)|0.43|||<|0.001|TWO_SIDED|95.0|0.27|0.67|||Regression, Logistic|||||0.67|0.27|<0.001
70888069|NCT04497987|141261988|SUPERIORITY||Odds Ratio (OR)|0.66||||0.021|TWO_SIDED|95.0|0.46|0.94|||Regression, Logistic|||||0.94|0.46|0.021
70888070|NCT00298038|141261994|SUPERIORITY|Analysis based on the overall comparison of time to the first breakthrough overt HE episode between rifaximin and placebo groups adjusting for analysis region, using the Cox proportional hazards model (Score test, \[that is, Log rank test stratified by analysis region\]) with a 2-sided test at a significance level of 0.05 under the proportional hazards assumption.|Hazard Ratio (HR)|0.421|||<|0.0001|TWO_SIDED|95.0|0.276|0.641|||Cox proportional hazards model|||||0.641|0.276|<0.0001
70888071|NCT04733157|141262003|OTHER||Risk Ratio (RR)|0.87|STANDARD_ERROR_OF_MEAN|0.1||0.33|TWO_SIDED|95.0|0.69|1.09||Threshold for statistical significance was 0.05|Chi-squared|||||1.09|0.69|0.33
70888072|NCT02573324|141262021|SUPERIORITY||Cox Proportional Hazard|1.02||||0.633|TWO_SIDED|95.0|0.82|1.26||Weighted log-rank P-value: Stratified Fleming-Harrington (ρ = 0, γ = 0.2) test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world, and EGFRvIII mutation status as covariates.|Terms abbreviated below: O6-methylguaninemethlytransferese (MGMT); Recursive Partitioning Analysis (RPA); EGFRde2-7 (EGFRvIII)||1.26|0.82|0.633
70888073|NCT02573324|141262021|SUPERIORITY|||||||0.704||||||Log-rank P-value (1-sided): Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank|||||||0.704
70888074|NCT02573324|141262022|SUPERIORITY||Cox Proportional Hazard|0.97||||0.504|TWO_SIDED|95.0|0.76|1.24||Weighted log-rank P-value: Stratified Fleming-Harrington (ρ = 0, γ = 0.2) test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world, and EGFRvIII mutation status as covariates.|||1.24|0.76|0.504
70888075|NCT02573324|141262022|SUPERIORITY|||||||0.599||||||Log-rank P-value (1-sided): Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank|||||||0.599
70888076|NCT02573324|141262023|SUPERIORITY||Cox Proportional Hazard|1.17||||0.773|TWO_SIDED|95.0|0.76|1.8||Weighted log-rank P-value: Stratified Fleming-Harrington (ρ = 0, γ = 0.2) test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world, and EGFRvIII mutation status as covariates.|||1.80|0.76|0.773
70888077|NCT02573324|141262023|SUPERIORITY|||||||0.74||||||Log-rank P-value (1-sided): Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank|||||||0.740
70888078|NCT02573324|141262024|SUPERIORITY||Cox Proportional Hazard|0.95||||0.381|TWO_SIDED|95.0|0.71|1.27||Weighted log-rank P-value: Stratified Fleming-Harrington (ρ = 0, γ = 0.2) test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.|||1.27|0.71|0.381
70888079|NCT02573324|141262024|SUPERIORITY|||||||0.409||||||Log-rank P-value (1-sided): Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank|||||||0.409
70888080|NCT02573324|141262025|SUPERIORITY||Cox Proportional Hazard|0.84||||0.029|TWO_SIDED|95.0|0.7|1.01||Stratified log-rank test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.|||1.01|0.70|0.029
70888081|NCT02573324|141262026|SUPERIORITY||Cox Proportional Hazard|0.72||||0.002|TWO_SIDED|95.0|0.56|0.93||Stratified log-rank test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.|||0.93|0.56|0.002
70888082|NCT02573324|141262027|SUPERIORITY||Cox Proportional Hazard|1.329||||0.994|TWO_SIDED|95.0|1.087|1.626||Stratified log-rank test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.|||1.626|1.087|0.994
70888083|NCT02573324|141262028|SUPERIORITY||Cox Proportional Hazard|1.185||||0.938|TWO_SIDED|95.0|0.972|1.446||Stratified log-rank test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.|||1.446|0.972|0.938
70888084|NCT02573324|141262029|SUPERIORITY||Cox Proportional Hazard|1.136||||0.814|TWO_SIDED|95.0|0.921|1.402||Stratified log-rank test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.|||1.402|0.921|0.814
70888085|NCT02096835|141262043|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Chi-squared|||||||0.021
70888086|NCT02096835|141262044|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Chi-squared|||||||0.021
70888087|NCT02096835|141262045|SUPERIORITY_OR_OTHER|||||||0.503|TWO_SIDED||||||Chi-squared|||||||0.503
70888088|NCT02096835|141262046|SUPERIORITY_OR_OTHER|||||||0.571|TWO_SIDED||||||Chi-squared|||||||0.571
70888089|NCT03892889|141262048|OTHER||||||<|0.0001|TWO_SIDED|||||Paired t-test was used based on the prospective phase efficacy sample when applicable.|paired t-test|||||||<0.0001
70888090|NCT01312909|141262082|SUPERIORITY||Odds Ratio (OR)|1.18||||0.6337|TWO_SIDED|95.0|0.59|2.37||Threshold for significance at 0.05 level.|Regression, Logistic|||Odds ratios and p-values were obtained from a logistic regression model with terms treatment, age strata, body weight strata and pooled center. A testing order was used to control type I error. 1mg Varenicline twice daily group was tested against placebo first, and if statistically significant difference was observed, the 0.5 mg Varenicline twice daily group was tested against placebo.||2.37|0.59|0.6337
70888091|NCT01312909|141262082|SUPERIORITY||Odds Ratio (OR)|1.73||||0.1114|TWO_SIDED|95.0|0.88|3.39||Threshold for significance at 0.05 level.|Regression, Logistic|||Odds ratios and p-values were obtained from a logistic regression model with terms treatment, age strata, body weight strata and pooled center. A testing order was used to control type I error. 1mg Varenicline twice daily group was tested against placebo first, and if statistically significant difference was observed, the 0.5 mg Varenicline twice daily group was tested against placebo.||3.39|0.88|0.1114
70888092|NCT01312909|141262083|SUPERIORITY||Odds Ratio (OR)|1.21||||0.5793|TWO_SIDED|95.0|0.62|2.38|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 12||2.38|0.62|0.5793
70888093|NCT01312909|141262083|SUPERIORITY||Odds Ratio (OR)|1.79||||0.0932|TWO_SIDED|95.0|0.91|3.51|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 12||3.51|0.91|0.0932
70888094|NCT01312909|141262083|SUPERIORITY||Odds Ratio (OR)|1.23||||0.5647|TWO_SIDED|95.0|0.61|2.5|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 24||2.50|0.61|0.5647
70888095|NCT01312909|141262083|SUPERIORITY||Odds Ratio (OR)|1.46||||0.2917|TWO_SIDED|95.0|0.72|2.96|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 24||2.96|0.72|0.2917
70888096|NCT01312909|141262083|SUPERIORITY||Odds Ratio (OR)|1.25||||0.5616|TWO_SIDED|95.0|0.58|2.69|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 52||2.69|0.58|0.5616
70888097|NCT01312909|141262083|SUPERIORITY||Odds Ratio (OR)|1.79||||0.13|TWO_SIDED|95.0|0.84|3.78|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 52||3.78|0.84|0.1300
70888098|NCT01312909|141262085|SUPERIORITY||Least square (LS) mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.58||0.354|TWO_SIDED|95.0|-1.69|0.6|||Longitudinal repeated measures model|||Week 12: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.||0.60|-1.69|0.3540
70888099|NCT01312909|141262085|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.59||0.7574|TWO_SIDED|95.0|-1.35|0.98|||Longitudinal repeated measures model|||Week 12: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.||0.98|-1.35|0.7574
70888100|NCT01312909|141262085|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.6||0.5676|TWO_SIDED|95.0|-1.53|0.84|||Longitudinal repeated measures model|||Week 24: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.||0.84|-1.53|0.5676
70888101|NCT01312909|141262085|SUPERIORITY||LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.61||0.2356|TWO_SIDED|95.0|-1.92|0.47|||Longitudinal repeated measures model|||Week 24: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.||0.47|-1.92|0.2356
70888102|NCT01312909|141262085|SUPERIORITY||LS mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.62||0.773|TWO_SIDED|95.0|-1.03|1.38|||Longitudinal repeated measures model|||Week 52: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.||1.38|-1.03|0.7730
70888103|NCT01312909|141262085|SUPERIORITY||LS mean difference|-0.77|STANDARD_ERROR_OF_MEAN|0.62||0.2166|TWO_SIDED|95.0|-1.99|0.45|||Longitudinal repeated measures model|||Week 52: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.||0.45|-1.99|0.2166
70888104|NCT01312909|141262086|SUPERIORITY||Odds Ratio (OR)|0.8||||0.6133|TWO_SIDED|95.0|0.34|1.9|||Regression, Logistic|||Week 9 through Week 24: Odds ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center, age strata and body weight strata.||1.90|0.34|0.6133
70888105|NCT01312909|141262086|SUPERIORITY||Odds Ratio (OR)|2.26||||0.0335|TWO_SIDED|95.0|1.07|4.79|||Regression, Logistic|||Week 9 through Week 24: Odds ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center, age strata and body weight strata.||4.79|1.07|0.0335
70888106|NCT01312909|141262086|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9874|TWO_SIDED|95.0|0.37|2.65|||Regression, Logistic|||Week 9 through Week 52: Odds ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center, age strata and body weight strata.||2.65|0.37|0.9874
70888107|NCT01312909|141262086|SUPERIORITY||Odds Ratio (OR)|2.79||||0.0188|TWO_SIDED|95.0|1.19|6.55|||Regression, Logistic|||Week 9 through Week 52: Odds ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center, age strata and body weight strata.||6.55|1.19|0.0188
70888108|NCT01777997|141262161|OTHER|||||||0.001|||||||Regression, repeated measures (GEE)|||Estimated mean change from baseline to weeks 24-48 on ART from repeated measures (GEE) model, against the null hypothesis of zero change. Estimated mean represents on ART levels minus pre-ART levels.||||0.001
70888109|NCT02660359|141262170|SUPERIORITY|If both p-values for the 2 primary tests (the test of Dysport® 800 U vs. placebo and the test of Dysport® 600 U vs. placebo) were lower than 0.05, both were declared statistically significant. If 1 of the primary tests had a p-value greater than or equal to 0.05, then the other test was declared statistically significant if its p-value was lower than 0.025 and only the significant dose continued in the hierarchal testing strategy.|LS Mean Difference|-8.97||||0.0001|TWO_SIDED|95.0|-13.5|-4.44|||MMLM|||Treatment group, visit (Week 6), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[Botulinum toxin \[BTX\]-naïve or BTX-non-naïve\]) and study baseline value (weekly number of UI episodes) as fixed effect variables, and subject as a random effect.||-4.44|-13.5|0.0001
70888110|NCT02660359|141262170|SUPERIORITY|If both p-values for the 2 primary tests (the test of Dysport® 800 U vs. placebo and the test of Dysport® 600 U vs. placebo) were lower than 0.05, both were declared statistically significant. If 1 of the primary tests had a p-value greater than or equal to 0.05, then the other test was declared statistically significant if its p-value was lower than 0.025 and only the significant dose continued in the hierarchal testing strategy.|LS Mean Difference|-9.76|||<|0.0001|TWO_SIDED|95.0|-14.41|-5.12|||MMLM|||Treatment group, visit (Week 6), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[Botulinum toxin \[BTX\]-naïve or BTX-non-naïve\]) and study baseline value (weekly number of UI episodes) as fixed effect variables, and subject as a random effect.||-5.12|-14.41|<0.0001
70888111|NCT02660359|141262171|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|Odds Ratio (OR)|45.55||||0.0002|TWO_SIDED|95.0|6.09|340.69|||Generalised linear mixed model (GLMM)|||Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline- by-visit interaction and study baseline weekly number of UI episodes as fixed effect.||340.69|6.09|0.0002
70888112|NCT02660359|141262171|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|Odds Ratio (OR)|31.69||||0.0009|TWO_SIDED|95.0|4.17|240.58|||GLMM|||Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.||240.58|4.17|0.0009
70888113|NCT02660359|141262172|SUPERIORITY|Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|3.55||||0.0007|TWO_SIDED|95.0|1.72|7.34||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥30% Improvement Level: Dysport® 600 U versus Placebo.||7.34|1.72|0.0007
70888114|NCT02660359|141262172|SUPERIORITY|Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|2.94||||0.0037|TWO_SIDED|95.0|1.43|6.07||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥30% Improvement Level: Dysport® 800 U versus Placebo||6.07|1.43|0.0037
70888115|NCT02660359|141262172|SUPERIORITY|Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|3.98|||<|0.0001|TWO_SIDED|95.0|2.03|7.79||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥50% Improvement level: Dysport® 600 U versus Placebo||7.79|2.03|<0.0001
70888116|NCT02660359|141262172|SUPERIORITY|Treatment group, recorded stratification factors, visit, treatment-by- visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|2.73||||0.0034|TWO_SIDED|95.0|1.4|5.33||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥50% Improvement level: Dysport® 800 U versus Placebo||5.33|1.40|0.0034
70888117|NCT02660359|141262172|SUPERIORITY|Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|7.38|||<|0.0001|TWO_SIDED|95.0|3.5|15.58||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥75% Improvement level: Dysport® 600 U versus Placebo||15.58|3.5|<0.0001
70888118|NCT02660359|141262172|SUPERIORITY|Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|5.28|||<|0.0001|TWO_SIDED|95.0|2.48|11.24||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥75% Improvement level: Dysport® 800 U versus Placebo||11.24|2.48|<0.0001
70888119|NCT02660359|141262174|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|96.14|||<|0.0001|TWO_SIDED|95.0|53.1|139.19|||MMRM|||Treatment group, visit (Week 6), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (total volume per void) as fixed effect variables, and subject as a random effect.||139.19|53.10|<0.0001
70888120|NCT02660359|141262174|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|90.78|||<|0.0001|TWO_SIDED|95.0|47.07|134.48|||MMRM|||Treatment group, visit (Week 6), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (total volume per void) as fixed effect variables, and subject as a random effect.||134.48|47.07|<0.0001
70888121|NCT02660359|141262175|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|175.0|||<|0.0001|TWO_SIDED|95.0|122.9|227.0|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX- naïve or BTX-non-naïve\]) and baseline value of MCC as covariates.||227.0|122.90|<0.0001
70888122|NCT02660359|141262175|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|168.4|||<|0.0001|TWO_SIDED|95.0|113.6|223.1|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX- naïve or BTX-non-naïve\]) and baseline value of MCC as covariates.||223.1|113.6|<0.0001
70888123|NCT02660359|141262176|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|-32.9|||<|0.0001|TWO_SIDED|95.0|-41.5|-24.4|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX- naïve or BTX-non-naïve\]) and baseline value of MDP as covariates.||-24.4|-41.5|<0.0001
70888124|NCT02660359|141262176|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|-32.5|||<|0.0001|TWO_SIDED|95.0|-41.5|-23.4|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX- naïve or BTX-non-naïve\]) and baseline value of MDP as covariates.||-23.4|-41.5|<0.0001
70888125|NCT02660359|141262177|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|152.8|||<|0.0001|TWO_SIDED|95.0|99.2|206.5|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX- naïve or BTX-non-naïve\]) and baseline value of Vol@1stIDC as covariates.||206.5|99.2|<0.0001
70888126|NCT02660359|141262177|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|169.7|||<|0.0001|TWO_SIDED|95.0|111.7|227.6|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX- naïve or BTX-non-naïve\]) and baseline value of Vol@1stIDC as covariates.||227.6|111.7|<0.0001
70888127|NCT02660359|141262178|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|Odds Ratio (OR)|31.1|||<|0.0001|TWO_SIDED|95.0|7.05|137.09|||GLMM|||Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.||137.09|7.05|<0.0001
70888128|NCT02660359|141262178|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|Odds Ratio (OR)|28.08|||<|0.0001|TWO_SIDED|95.0|6.24|126.25|||GLMM|||Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by- visit interaction and study baseline weekly number of UI episodes as fixed effect.||126.25|6.24|<0.0001
70888129|NCT00127790|141262179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0||||0.01|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.010
70888130|NCT00127790|141262179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.581|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.581
70888131|NCT00127790|141262179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6||||0.011|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores||||0.011
70888132|NCT00127790|141262180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.33|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.33
70888133|NCT00127790|141262180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.112|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.112
70888134|NCT00127790|141262180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.737|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores||||0.737
70888135|NCT00127790|141262181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.063|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores||||0.063
70888136|NCT00127790|141262181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.786|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores||||0.786
70888137|NCT00127790|141262181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.039|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.039
70888138|NCT00127790|141262182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.2||||0.016|||||||Generlaized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.016
70888139|NCT00127790|141262182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.4||||0.187|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.187
70888140|NCT00127790|141262182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.2||||0.015|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.015
70888141|NCT01257204|141262237|SUPERIORITY_OR_OTHER||Difference|20.8|||||TWO_SIDED|80.0|4.9|36.8|||||The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.|||36.8|4.9|
70888142|NCT01257204|141262237|SUPERIORITY_OR_OTHER||Difference|20.1|||||TWO_SIDED|80.0|3.9|36.3|||||The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.|||36.3|3.9|
70888143|NCT01257204|141262246|SUPERIORITY_OR_OTHER||Difference|10.0|||||TWO_SIDED|80.0|-6.8|26.7|||||The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.|||26.7|-6.8|
70888144|NCT01257204|141262246|SUPERIORITY_OR_OTHER||Difference|7.4|||||TWO_SIDED|80.0|-9.4|24.2|||||The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.|||24.2|-9.4|
70888145|NCT00451282|141262254|SUPERIORITY_OR_OTHER|||||||0.69|||||||t-test, 2 sided|||||||.69
70888146|NCT00451282|141262255|SUPERIORITY_OR_OTHER|||||||0.89|||||||t-test, 2 sided|||||||.89
70888147|NCT00451282|141262256|SUPERIORITY_OR_OTHER|||||||0.69|||||||t-test, 2 sided|||||||.69
70888148|NCT00451282|141262257|SUPERIORITY_OR_OTHER|||||||0.18|||||||t-test, 2 sided|||||||.18
70888149|NCT01174030|141262265|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.392|||<|0.001||95.0|2.637|26.71|||GEE:Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||26.710|2.637|<0.001
70888150|NCT01174030|141262265|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.269||||0.549||95.0|0.586|2.747|||GEE:Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||2.747|0.586|0.549
70888151|NCT01174030|141262265|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.738||||0.027||95.0|1.097|12.742|||GEE:Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||12.742|1.097|0.027
70888152|NCT01174030|141262266|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.683||||0.003||95.0|1.388|5.188|||GEE:Logit link Function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model||||5.188|1.388|.003
70888153|NCT01174030|141262266|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.892||||0.056||95.0|0.98|3.651|||GEE: Logit link Function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||3.651|0.980|0.056
70888154|NCT01174030|141262266|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.885||||0.074||95.0|0.946|3.756|||GEE:Logit link Function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||3.756|0.946|0.074
70888155|NCT01174030|141262267|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.582|||<|0.001||95.0|2.755|15.723|||GEE: Logit link function|Generalize Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||15.723|2.755|<0.001
70888156|NCT01174030|141262267|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.853||||0.093||95.0|0.903|3.802|||GEE: Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||3.802|0.903|0.093
70888157|NCT01174030|141262267|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.365||||0.054||95.0|0.96|5.825|||GEE: Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||5.825|0.960|0.054
70888158|NCT02732847|141262298|OTHER|Chi square tests used to compared groups||||||0.924||||||A p-value of \< 0.05 was considered|Chi-squared|||||||0.924
70888159|NCT03304379|141262388|SUPERIORITY||Least Square (LS) Mean Difference|-0.63|||=|0.0003|TWO_SIDED|95.0|-0.971|-0.286||Threshold for significance at 0.05 level.|MMRM|||Analyses were based on a multiple imputation approach using a Mixed-Effect Model With Repeated Measure (MMRM) model with baseline randomization strata, baseline, treatment, visit and treatment by-visit interaction.||-0.286|-0.971|= 0.0003
70888160|NCT03304379|141262388|SUPERIORITY||LS Mean Difference|-0.77|||>|0.0001|TWO_SIDED|95.0|-1.154|-0.383||Threshold for significance at 0.05 level.|MMRM|||"(mFAS)~Analyses were based on a multiple imputation approach using a MMRM model with baseline, randomization strata, baseline, treatment, visit and treatment by-visit interaction"||-0.383|-1.154|> 0.0001
70888161|NCT03304379|141262389|SUPERIORITY||LS Mean Difference|-0.64|||=|0.0003|TWO_SIDED|95.0|-0.981|-0.29||Threshold for significance at 0.05 level.|MMRM|||Analyses were based on a multiple imputation approach using a Mixed-Effect Model With Repeated Measure (MMRM) model with baseline randomization strata, baseline, treatment, visit and treatment by-visit interaction.||-0.290|-0.981|= 0.0003
70888162|NCT03304379|141262389|SUPERIORITY||LS Mean Difference|-0.82|||<|0.0001|TWO_SIDED|95.0|-1.198|-0.443||Threshold for significance at 0.05 level|MMRM|||"(mFAS)~Analyses were based on a multiple imputation approach using an Mixed-Effect Model With Repeated Measure (MMRM) model with baseline randomization strata, baseline, treatment, visit and treatment by-visit interaction."||-0.443|-1.198|<0.0001
70888163|NCT03304379|141262390|SUPERIORITY||Odds Ratio (OR)|1.581|||=|0.0013|TWO_SIDED|95.0|1.195|2.092||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Analyses are based on Cochran-Mantel-Haenszel model.||2.092|1.195|= 0.0013
70888164|NCT03304379|141262391|SUPERIORITY||LS Mean Difference|-0.14|||=|0.0365|TWO_SIDED|95.0|-0.28|-0.009||Threshold for significance at 0.05 level.|MMRM|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Analyses are based on a multiple imputation approach using Mixed-Effect Model With Repeated Measure (MMRM) model.||-0.009|-0.28|= 0.0365
70888165|NCT01298063|141262411|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|92.64|STANDARD_DEVIATION|33.6||0.1998|TWO_SIDED|90.0|67.96|126.27||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation|||126.270|67.960|0.1998
70888166|NCT01298063|141262411|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|94.88|STANDARD_DEVIATION|31.6||0.144|TWO_SIDED|90.0|72.278|124.549||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation|||124.549|72.278|0.1440
70888167|NCT01298063|141262412|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|109.47|STANDARD_DEVIATION|30.3||0.2002|TWO_SIDED|90.0|82.683|144.947||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation|||144.947|82.683|0.2002
70888168|NCT01298063|141262412|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|126.89|STANDARD_DEVIATION|42.8||0.5281|TWO_SIDED|90.0|86.028|187.159||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation|||187.159|86.028|0.5281
70888169|NCT01298063|141262413|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|90.61|STANDARD_DEVIATION|32.8||0.2309|TWO_SIDED|90.0|66.915|122.705||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation|||122.705|66.915|0.2309
70888170|NCT01298063|141262413|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|94.49|STANDARD_DEVIATION|32.4||0.1546|TWO_SIDED|90.0|71.563|124.764||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation|||124.764|71.563|0.1546
70888171|NCT00395044|141262415|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Mixed Models Analysis|||||||.029
70888172|NCT03282955|141262487|NON_INFERIORITY|Non-inferiority margin= 1.151||||||0.025|||||||t-test, 1 sided|||||||0.025
70888173|NCT02550652|141262525|SUPERIORITY||Difference in Percentage of Participants|12.3||||0.1145|TWO_SIDED|95.0|-3.4|28.1||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||28.1|-3.4|0.1145
70888174|NCT02550652|141262525|SUPERIORITY||Difference in Percentage of Participants|12.3||||0.1145|TWO_SIDED|80.0|2.1|22.6||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|Difference in Percentage of Participants||||22.6|2.1|0.1145
70888175|NCT02550652|141262526|SUPERIORITY||Difference in Percentage of Participants|20.1||||0.0246||95.0|3.0|37.2||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||37.2|3.0|0.0246
70888176|NCT02550652|141262526|SUPERIORITY||Difference in Percentage of Participants|20.1||||0.0246|TWO_SIDED|80.0|8.9|31.3||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||31.3|8.9|0.0246
70888177|NCT02550652|141262527|SUPERIORITY|||||||0.0744|||||||Log Rank|||||||0.0744
70888178|NCT02550652|141262528|SUPERIORITY||Difference in Percentage of Participants|21.7||||0.015||95.0|4.7|38.7||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||38.7|4.7|0.0150
70888179|NCT02550652|141262528|SUPERIORITY||Difference in Percentage of Participants|21.7||||0.015|TWO_SIDED|80.0|10.6|32.8||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||32.8|10.6|0.0150
70888180|NCT02550652|141262529|SUPERIORITY||Difference in Percentage of Participants|-2.0||||0.8461|TWO_SIDED|95.0|-17.5|13.4||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||13.4|-17.5|0.8461
70888181|NCT02550652|141262529|SUPERIORITY||Difference in Percentage of Participants|-2.0||||0.8461|TWO_SIDED|80.0|-12.1|8.1||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||8.1|-12.1|0.8461
70888182|NCT02550652|141262530|SUPERIORITY|||||||0.353|||||||Log Rank|||||||0.3530
70888183|NCT02550652|141262531|SUPERIORITY||Difference in Adjusted Mean|-0.81|||<|0.0001|TWO_SIDED|95.0|-1.13|-0.491||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|ANCOVA|||||-0.491|-1.13|<0.0001
70888184|NCT02550652|141262531|SUPERIORITY||Difference in Adjusted Mean|-0.81|||<|0.0001|TWO_SIDED|80.0|-1.019|-0.602||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|ANCOVA|||||-0.602|-1.019|<0.0001
70888185|NCT02550652|141262532|SUPERIORITY||Difference in Adjusted Mean|0.178||||0.0004|TWO_SIDED|95.0|0.081|0.275||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|ANCOVA|||||0.275|0.081|0.0004
70888186|NCT02550652|141262532|SUPERIORITY||Difference in Adjusted Mean|0.178||||0.0004|TWO_SIDED|80.0|0.115|0.241|||ANCOVA|||||0.241|0.115|0.0004
70888187|NCT02550652|141262533|SUPERIORITY||Difference in Adjusted Mean|0.088|||<|0.0001||95.0|0.052|0.124|||ANCOVA|Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).||||0.124|0.052|<0.0001
70888188|NCT02550652|141262533|SUPERIORITY||Difference in Adjusted Mean|0.088|||<|0.0001|TWO_SIDED|80.0|0.065|0.112||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|ANCOVA|||||0.112|0.065|<0.0001
70888189|NCT02550652|141262534|SUPERIORITY||Difference in Percentage of Participants|13.9||||0.09||95.0|-2.4|30.1||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%"|Cochran-Mantel-Haenszel|||||30.1|-2.4|0.0900
70888190|NCT02550652|141262534|SUPERIORITY||Difference in Percentage of Participants|13.9||||0.09|TWO_SIDED|80.0|3.2|24.5||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%"|Cochran-Mantel-Haenszel|||||24.5|3.2|0.0900
70888191|NCT02550652|141262535|SUPERIORITY||Difference in Percentage of Participants|10.6||||0.1838|TWO_SIDED|95.0|-6.4|27.6||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%"|Cochran-Mantel-Haenszel|||||27.6|-6.4|0.1838
70888192|NCT02550652|141262535|SUPERIORITY||Difference in Percentage of Participants|10.6||||0.1838|TWO_SIDED|80.0|-0.5|21.7||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%"|Cochran-Mantel-Haenszel|||||21.7|-0.5|0.1838
70888193|NCT02550652|141262536|SUPERIORITY||Difference in Percentage of Participants|7.3||||0.3726|TWO_SIDED|95.0|-10.0|24.6||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||24.6|-10.0|0.3726
70888194|NCT02550652|141262536|SUPERIORITY||Difference in Percentage of Participants|7.3||||0.3726|TWO_SIDED|80.0|-4.0|18.6||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%"|Cochran-Mantel-Haenszel|||||18.6|-4.0|0.3726
70888195|NCT00515827|141262557|SUPERIORITY_OR_OTHER_LEGACY|||||||0.546||95.0||||P-value is 2-sided and is not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||0.546
70888196|NCT03181542|141262566|SUPERIORITY|||||||0.34|||||||Fisher Exact|||||||0.34
70888197|NCT03181542|141262567|SUPERIORITY|||||||0.4|||||||Jonckheere-Terpstra Test|||||||0.40
70888198|NCT03181542|141262568|SUPERIORITY|||||||0.9|||||||Jonckheere-Terpstra Test|||||||0.90
70888199|NCT01833403|141262569|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70888200|NCT02553746|141262573|SUPERIORITY|||||||0.748|||||||Chi-squared, Corrected|||||||0.748
70888201|NCT02553746|141262574|SUPERIORITY|||||||0.498|||||||Chi-squared, Corrected|||||||0.498
70888202|NCT02553746|141262575|SUPERIORITY|||||||0.171|||||||Wilcoxon (Mann-Whitney)|||||||0.171
70888203|NCT02553746|141262576|SUPERIORITY|||||||0.162|||||||Wilcoxon (Mann-Whitney)|||||||0.162
70888204|NCT02553746|141262577|SUPERIORITY|||||||0.104|||||||Chi-squared, Corrected|||||||0.104
70888205|NCT02553746|141262578|SUPERIORITY||||||<|0.005|||||||Wilcoxon (Mann-Whitney)|||||||<0.005
70888206|NCT04035486|141262640|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.49|0.79|||Log Rank||A hazard ratio of less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||0.79|0.49|<0.0001
70888207|NCT04035486|141262641|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.0002|TWO_SIDED|95.0|0.48|0.8|||Log Rank||A hazard ratio of less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||0.80|0.48|0.0002
70888208|NCT04035486|141262646|OTHER||Percentage of Participants|100.0|||||TWO_SIDED|95.0|88.43|100.0|||Clopper-Pearson|||A 95% CI was calculated on the percentage of participants with a Response or Stable Disease using the exact (Clopper-Pearson) method.||100.00|88.43|
70888209|NCT04035486|141262647|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.5238|TWO_SIDED|95.0|0.65|1.24|||Log Rank||A hazard ratio of less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).|An adjusted CI of (0.54, 1.51) was computed at the 2-sided 99.84% level, considering a 2-sided significance level of 0.00158 for the overall survival interim analysis, based on the O'Brien and Fleming spending function, assuming 334 deaths for the final overall survival analysis.|1.24|0.65|0.5238
70888210|NCT04035486|141262649|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0261|TWO_SIDED|95.0|1.06|2.44|||Regression, Logistic||And odds ratio of greater than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a logistic regression stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||2.44|1.06|0.0261
70888211|NCT04035486|141262651|SUPERIORITY||Least Square Mean Difference|-3.36||||0.1067|TWO_SIDED|95.0|-7.44|0.72|||ANCOVA||A difference in least square means less than 0 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using analysis of covariance with baseline tumor size and time from baseline scan to randomization as covariates and with factors race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||0.72|-7.44|0.1067
70888212|NCT04035486|141262652|SUPERIORITY||Odds Ratio (OR)|1.33||||0.4483|TWO_SIDED|95.0|0.63|2.81|||Regression, Logistic||An odds ratio greater than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a logistic regression stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||2.81|0.63|0.4483
70888213|NCT04035486|141262653|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0132|TWO_SIDED|95.0|0.52|0.93|||Log Rank||A hazard ratio less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||0.93|0.52|0.0132
70888214|NCT04035486|141262654|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0159|TWO_SIDED|95.0|0.56|0.94|||Log Rank||A hazard ratio less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||0.94|0.56|0.0159
70888215|NCT04035486|141262655|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0157|TWO_SIDED|95.0|0.51|0.93|||Log Rank||A hazard ratio less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||0.93|0.51|0.0157
70888216|NCT04035486|141262662|SUPERIORITY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.44|0.83|||Cox proportional hazards model||A hazard ratio less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|Subgroup analysis was performed using a Cox proportional hazards model including treatment, subgroup and a treatment-by subgroup interaction term.||0.83|0.44|
70888217|NCT04035486|141262663|SUPERIORITY||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.44|0.9|||||A hazard ratio less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|Subgroup analysis was performed using a Cox proportional hazards model including treatment, subgroup and a treatment-by subgroup interaction term.||0.90|0.44|
70888218|NCT02556710|141262674|SUPERIORITY|||||||0.94|||||||ANCOVA|Adjusted for baseline WOMAC Score||||||0.94
70888219|NCT02556710|141262675|SUPERIORITY|||||||0.53|||||||ANCOVA|Adjusted for baseline WOMAC score||||||0.53
70888220|NCT02556710|141262676|SUPERIORITY|||||||0.35||||||Adjusted for baseline WOMAC Score.|ANCOVA|||||||0.35
70888221|NCT01602315|141262719|SUPERIORITY_OR_OTHER_LEGACY||median HR|0.99||||||||||||||The hazard ratio was estimated using the Bayesian Cox proportional hazard (PH) model.||||
70888222|NCT01602315|141262719|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.12||||0.643|TWO_SIDED|95.0|0.69|1.82|||Regression, Cox|||||1.82|0.69|0.643
70888223|NCT01602315|141262719|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.54||||0.039|TWO_SIDED|95.0|0.3|0.97|||Regression, Cox|||Adjusted on Covariates: treatment, sum of longest diameters from central data \[SLD (C)\], Hemaglobin (Hgb) and White Blood Cells (WBC).||0.97|0.30|0.039
70888224|NCT01602315|141262722|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier method (median)|43.0|||||TWO_SIDED|95.0|27.0|88.0|||||days|||88.0|27.0|
70888225|NCT01602315|141262728|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.28||||0.313|TWO_SIDED|95.0|0.79|2.05|||Regression, Cox|||||2.05|0.79|0.313
70888226|NCT01602315|141262729|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier (median)|294.0|||||TWO_SIDED|95.0|172.0|463.0||||||||463.0|172.0|
70888227|NCT01602315|141262743|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||0.235|TWO_SIDED|95.0|0.49|1.19|||Regression, Cox|||||1.19|0.49|0.235
70888228|NCT01602315|141262743|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.64||||0.062|TWO_SIDED|95.0|0.4|1.02|||Regression, Cox|||Adjusted on Covariates: treatment, sum of longest diameters from local data \[SLD (L)\], Hemaglobin (Hgb) and White Blood Cells (WBC).||1.02|0.4|0.062
70888229|NCT04086472|141262777|SUPERIORITY||Least squares (LS) Mean Difference|-1.31||||0.808|TWO_SIDED|90.0|-10.25|7.64|||ANOVA|||Treatment vs. Placebo||7.64|-10.25|0.808
70888230|NCT04086472|141262777|SUPERIORITY||LS Mean Difference|-6.51||||0.229|TWO_SIDED|90.0|-15.46|2.43|||ANOVA|||Treatment vs. Placebo||2.43|-15.46|0.229
70888231|NCT04086472|141262777|SUPERIORITY||LS Mean Difference|-4.81||||0.363|TWO_SIDED|90.0|-13.58|3.96|||ANOVA|||Treatment vs. Placebo||3.96|-13.58|0.363
70888232|NCT04086472|141262777|SUPERIORITY||LS Mean Difference|-5.92||||0.273|TWO_SIDED|90.0|-14.87|3.02|||ANOVA|||Treatment vs. Placebo||3.02|-14.87|0.273
70888233|NCT04086472|141262778|OTHER|Treatment vs. Placebo|Difference in percentage|0.51|||||TWO_SIDED|95.0|-36.57|37.78|||||95% CI based on the Chan and Zhang exact method|||37.78|-36.57|
70888234|NCT04086472|141262778|OTHER|Treatment vs. Placebo|Difference in percentage|-22.56|||||TWO_SIDED|95.0|-56.7|15.53|||||95% CI based on the Chan and Zhang exact method|||15.53|-56.70|
70888235|NCT04086472|141262778|OTHER|Treatment vs. Placebo|Difference in percentage|-17.62|||||TWO_SIDED|95.0|-53.09|20.01|||||95% CI based on the Chan and Zhang exact method|||20.01|-53.09|
70888236|NCT04086472|141262778|OTHER|Treatment vs. Placebo|Difference in percentage|-22.56|||||TWO_SIDED|95.0|-56.7|15.53|||||95% CI based on the Chan and Zhang exact method|Treatment vs. Placebo||15.53|-56.70|
70888237|NCT00844545|141262783|SUPERIORITY_OR_OTHER||LS mean change from baseline|65.18|||<|0.0001|TWO_SIDED|95.0|37.01|93.36|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||With at least 12 patients enrolled and assuming a null hypothesis of no post-dose change from baseline in mean platelet count, the study had approximately 88% power to detect as statistically significant an effect size (mean change from baseline/standard deviation) of at least 1 when using a one sample t-test with a two-sided α=0.05. All analyses were based on the pooled data from the two protocols: C08-002A (adult) and C08-002B (adolescent), a similar protocol, for patients \<18 years with aHUS.||93.36|37.01|<0.0001
70888238|NCT00844545|141262784|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|82.0|||||TWO_SIDED|95.0|57.0|96.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||96|57|
70888239|NCT00844545|141262785|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|76.0|||||TWO_SIDED|95.0|50.0|93.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||93|50|
70888240|NCT00844545|141262786|SUPERIORITY_OR_OTHER||Percent of complete TMA response|65.0|||||TWO_SIDED|95.0|38.0|86.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||86|38|
70888241|NCT00844545|141262787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||||<0.0001
70888242|NCT00844545|141262788|SUPERIORITY_OR_OTHER||LS mean change from baseline|111.62|||<|0.0001|TWO_SIDED|95.0|98.12|125.13|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||125.13|98.12|<0.0001
70888243|NCT00844545|141262789|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|88.0|||||TWO_SIDED|95.0|64.0|99.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||99|64|
70888244|NCT00844545|141262790|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|88.0|||||TWO_SIDED|95.0|64.0|99.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||99|64|
70888245|NCT00844545|141262791|SUPERIORITY_OR_OTHER||Percent of complete TMA response|76.0|||||TWO_SIDED|95.0|50.0|93.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||93|50|
70888246|NCT00844545|141262792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||||<0.0001
70888247|NCT02809976|141262817|OTHER|single group/descriptive analysis||||||0.02|||||||paired t-test|||||||0.02
70888248|NCT04394351|141262834|SUPERIORITY||Odds Ratio (OR)|53.8|||<|0.0001|TWO_SIDED|95.0|7.37|392.82|||Cochran-Mantel-Haenszel|p-value was derived by Cochran-Mantel-Haenszel (CMH) test stratified by baseline weight group.|Odds ratio and corresponding Confidence Interval (CI) are based on CMH test stratified by baseline weight group.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||392.82|7.37|<0.0001
70888249|NCT04394351|141262834|SUPERIORITY||Odds Ratio (OR)|46.7|||<|0.0001|TWO_SIDED|95.0|5.47|399.54|||Cochran-Mantel-Haenszel|p-value was derived by CMH test stratified by baseline weight group.|Odds ratio and corresponding CI are based on CMH test stratified by baseline weight group.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||399.54|5.47|<0.0001
70888250|NCT04394351|141262835|SUPERIORITY||Odds Ratio (OR)|178.0|||<|0.0001|TWO_SIDED|95.0|18.84|1682.4|||Cochran-Mantel-Haenszel|p-value was derived by CMH test stratified by baseline weight group|Odds ratio and corresponding CI are based on CMH test stratified by baseline weight group|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||1682.4|18.84|<0.0001
70888251|NCT04394351|141262835|SUPERIORITY||Odds Ratio (OR)|55.3|||<|0.0001|TWO_SIDED|95.0|7.45|410.23||P-value is not adjusted for multiple comparisons|Cochran-Mantel-Haenszel|p-value was derived by CMH test stratified by baseline weight group|Odds ratio and corresponding CI are based on CMH test stratified by baseline weight group|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||410.23|7.45|<0.0001
70888252|NCT04394351|141262836|SUPERIORITY||LS mean difference|-107.07|||<|0.0001|TWO_SIDED|95.0|-139.249|-74.9|||ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||-74.900|-139.249|<0.0001
70888253|NCT04394351|141262836|SUPERIORITY||LS mean difference|-98.92|||<|0.0001|TWO_SIDED|95.0|-132.463|-65.37||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||-65.370|-132.463|<0.0001
70888254|NCT04394351|141262837|SUPERIORITY||LS mean difference|-0.902|||<|0.0001|TWO_SIDED|95.0|-1.0325|-0.7714|||ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||-0.7714|-1.0325|<0.0001
70888255|NCT04394351|141262837|SUPERIORITY||LS mean difference|-0.78|||<|0.0001|TWO_SIDED|95.0|-0.917|-0.644||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||-0.6440|-0.9170|<0.0001
70888256|NCT04394351|141262838|SUPERIORITY||LS mean difference|-0.883|||<|0.0001|TWO_SIDED|95.0|-1.0095|-0.7568|||ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||-0.7568|-1.0095|<0.0001
70888257|NCT04394351|141262838|SUPERIORITY||LS mean difference|-0.769|||<|0.0001|TWO_SIDED|95.0|-0.9013|-0.6362||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||-0.6362|-0.9013|<0.0001
70888258|NCT04394351|141262839|SUPERIORITY||Hodges-Lehmann estimator|-2.22|||<|0.0001|TWO_SIDED|95.0|-2.44|-1.95|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||-1.9500|-2.4400|<0.0001
70888259|NCT04394351|141262839|SUPERIORITY||Hodges-Lehmann estimator|-2.19|||<|0.0001|TWO_SIDED|95.0|-2.45|-1.82||P-value is not adjusted for multiple comparisons|Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||-1.8200|-2.4500|<0.0001
70888260|NCT04394351|141262840|SUPERIORITY||Hodges-Lehmann estimator|-2.84|||<|0.0001|TWO_SIDED|95.0|-3.35|-1.96|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||-1.9600|-3.3500|<0.0001
70888261|NCT04394351|141262840|SUPERIORITY||Hodges-Lehmann estimator|-2.7|||<|0.0001|TWO_SIDED|95.0|-3.31|-1.62||P-value is not adjusted for multiple comparisons|Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||-1.6200|-3.3100|<0.0001
70888262|NCT04394351|141262841|SUPERIORITY||LS mean difference|-3.8|||<|0.0001|TWO_SIDED|95.0|-4.94|-2.63|||ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||-2.63|-4.94|<0.0001
70888263|NCT04394351|141262841|SUPERIORITY||LS mean difference|-3.3|||<|0.0001|TWO_SIDED|95.0|-4.59|-2.1||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||-2.10|-4.59|<0.0001
70888264|NCT04394351|141262842|SUPERIORITY||LS mean difference|-0.1||||0.1526|TWO_SIDED|95.0|-0.244|0.038|||ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||0.038|-0.244|0.1526
70888265|NCT04394351|141262842|SUPERIORITY||LS mean difference|0.0||||0.9533|TWO_SIDED|95.0|-0.155|0.146||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||0.146|-0.155|0.9533
70888266|NCT04394351|141262843|SUPERIORITY||LS mean difference|1.45||||0.1507|TWO_SIDED|95.0|-0.527|3.422||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||3.422|-0.527|0.1507
70888267|NCT04394351|141262843|SUPERIORITY||LS mean difference|0.0||||0.9965|TWO_SIDED|95.0|-2.107|2.117||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||2.117|-2.107|0.9965
70888268|NCT04394351|141262844|SUPERIORITY||LS mean difference|-0.05||||0.2064|TWO_SIDED|95.0|-0.139|0.03||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||0.030|-0.139|0.2064
70888269|NCT04394351|141262844|SUPERIORITY||LS mean difference|0.02||||0.6361|TWO_SIDED|95.0|-0.069|0.112||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||0.112|-0.069|0.6361
70888270|NCT04394351|141262845|SUPERIORITY||LS mean difference|0.13||||0.2086|TWO_SIDED|95.0|-0.072|0.33||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||0.330|-0.072|0.2086
70888271|NCT04394351|141262845|SUPERIORITY||LS mean difference|0.1||||0.2975|TWO_SIDED|95.0|-0.088|0.286||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||0.286|-0.088|0.2975
70888272|NCT04394351|141262846|SUPERIORITY||LS mean difference|-1.8||||0.2085|TWO_SIDED|95.0|-4.615|1.007||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||1.007|-4.615|0.2085
70888273|NCT04394351|141262846|SUPERIORITY||LS mean difference|-1.36||||0.3098|TWO_SIDED|95.0|-3.972|1.26||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||1.260|-3.972|0.3098
70888274|NCT04394351|141262847|SUPERIORITY||LS mean difference|0.07||||0.236|TWO_SIDED|95.0|-0.046|0.186||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||0.186|-0.046|0.2360
70888275|NCT04394351|141262847|SUPERIORITY||LS mean difference|0.07||||0.1939|TWO_SIDED|95.0|-0.037|0.181||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||0.181|-0.037|0.1939
70888276|NCT04574362|141262940|SUPERIORITY||Risk Difference (RD)|9.2|||<|0.0001|TWO_SIDED|95.0|5.4|13.0|||Cochran-Mantel-Haenszel||Risk difference and associated 95 percent (%) confidence interval (CI) were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||13.0|5.4|<0.0001
70888277|NCT04574362|141262941|SUPERIORITY||Risk Difference (RD)|14.8|||<|0.0001|TWO_SIDED|95.0|9.6|20.0|||Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||20.0|9.6|<0.0001
70888278|NCT04574362|141262942|SUPERIORITY||Risk Difference (RD)|18.1|||<|0.0001|TWO_SIDED|95.0|13.0|23.3|||Cochran-Mantel-Haenszel|Within the family of key secondary endpoints, multiplicity was controlled using the Hochberg procedure.|Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||23.3|13.0|<0.0001
70888279|NCT04574362|141262943|SUPERIORITY||Risk Difference (RD)|16.9|||<|0.0001|TWO_SIDED|95.0|11.4|22.3|||Cochran-Mantel-Haenszel|Within the family of key secondary endpoints, multiplicity was controlled using the Hochberg procedure.|Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||22.3|11.4|<0.0001
70888280|NCT04574362|141262944|SUPERIORITY||Risk Difference (RD)|-11.5|||<|0.0001|TWO_SIDED|95.0|-15.0|-8.0|||Cochran-Mantel-Haenszel|Within the family of key secondary endpoints, multiplicity was controlled using the Hochberg procedure.|Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||-8.0|-15.0|<0.0001
70888281|NCT04574362|141262945|SUPERIORITY||Risk Difference (RD)|7.7|||<|0.0001|TWO_SIDED|95.0|4.3|11.2|||Cochran-Mantel-Haenszel|Within the family of key secondary endpoints, multiplicity was controlled using the Hochberg procedure.|Risk differences and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||11.2|4.3|<0.0001
70888282|NCT04574362|141262946|SUPERIORITY||Risk difference|7.7|||<|0.0001|TWO_SIDED|95.0|4.4|11.0|||Cochran-Mantel-Haenszel|Within the family of key secondary endpoints, multiplicity was controlled using the Hochberg procedure.|Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||11.0|4.4|<0.0001
70888283|NCT04574362|141262947|SUPERIORITY||Risk difference|-0.7||||0.2057|TWO_SIDED|95.0|-1.9|0.4||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|15 minutes post-dose||0.4|-1.9|0.2057
70888284|NCT04574362|141262947|SUPERIORITY||Risk Difference (RD)|0.0||||0.9702|TWO_SIDED|95.0|-1.1|1.1||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|30 minutes post-dose||1.1|-1.1|0.9702
70888285|NCT04574362|141262947|SUPERIORITY||Risk Difference (RD)|1.0||||0.2419|TWO_SIDED|95.0|-0.7|2.8||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|45 minutes post-dose||2.8|-0.7|0.2419
70888286|NCT04574362|141262947|SUPERIORITY||Risk Difference (RD)|2.4||||0.0597|TWO_SIDED|95.0|-0.1|4.8||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|60 minutes post-dose||4.8|-0.1|0.0597
70888287|NCT04574362|141262947|SUPERIORITY||Risk Difference (RD)|5.2||||0.0012|TWO_SIDED|95.0|2.1|8.4||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|90 minutes post-dose||8.4|2.1|0.0012
70888288|NCT04574362|141262948|SUPERIORITY||Risk Difference (RD)|-0.7||||0.6809|TWO_SIDED|95.0|-3.9|2.5||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|15 minutes post-dose||2.5|-3.9|0.6809
70888289|NCT04574362|141262948|SUPERIORITY||Risk Difference (RD)|2.2||||0.2586|TWO_SIDED|95.0|-1.6|6.0||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|30 minutes post-dose||6.0|-1.6|0.2586
70888290|NCT04574362|141262948|SUPERIORITY||Risk Difference (RD)|4.5||||0.0421|TWO_SIDED|95.0|0.2|8.8||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|45 minutes post-dose||8.8|0.2|0.0421
70888291|NCT04574362|141262948|SUPERIORITY||Risk Difference (RD)|6.6||||0.0066|TWO_SIDED|95.0|1.8|11.3||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|60 minutes post-dose||11.3|1.8|0.0066
70888292|NCT04574362|141262948|SUPERIORITY||Risk Difference (RD)|9.9||||0.0002|TWO_SIDED|95.0|4.8|14.9||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|90 minutes post-dose||14.9|4.8|0.0002
70888293|NCT04574362|141262949|SUPERIORITY||Risk Difference (RD)|-10.4||||0.1148|TWO_SIDED|95.0|-23.5|2.8||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||2.8|-23.5|0.1148
70888294|NCT02002767|141262952|OTHER||Geometric Least Squares Mean(GLSM) Ratio|149.05|||||TWO_SIDED|90.0|116.62|190.49||||||A sample size of 8 evaluable participants in each renal function group (normal and severely impaired) will provide at least 80% power to reject the null hypothesis that participants with severe renal impairment have a minimum increase of 100% in AUC0-last, AUCinf, or Cmax of velpatasvir compared to participants with normal renal function.||190.49|116.62|
70888295|NCT02002767|141262953|OTHER||GLSM Ratio|149.9|||||TWO_SIDED|90.0|116.97|192.11||||||A sample size of 8 evaluable participants in each renal function group (normal and severely impaired) will provide at least 80% power to reject the null hypothesis that participants with severe renal impairment have a minimum increase of 100% in AUC0-last, AUCinf, or Cmax of velpatasvir compared to participants with normal renal function.||192.11|116.97|
70888296|NCT02002767|141262954|OTHER||GLSM Ratio|110.85|||||TWO_SIDED|90.0|90.76|135.38||||||A sample size of 8 evaluable participants in each renal function group (normal and severely impaired) will provide at least 80% power to reject the null hypothesis that participants with severe renal impairment have a minimum increase of 100% in AUC0-last, AUCinf, or Cmax of velpatasvir compared to participants with normal renal function.||135.38|90.76|
70888297|NCT00812929|141262958|SUPERIORITY||Mean Difference (Net)|1.29|STANDARD_ERROR_OF_MEAN|1.44|||TWO_SIDED|95.0|-1.56|4.13||||||||4.13|-1.56|
70888298|NCT00812929|141262958|SUPERIORITY||Mean Difference (Net)|0.53|STANDARD_ERROR_OF_MEAN|1.44|||TWO_SIDED|95.0|-2.32|3.37||||||||3.37|-2.32|
70888299|NCT00812929|141262958|SUPERIORITY||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|1.441|||TWO_SIDED|95.0|-2.52|3.18||||||||3.18|-2.52|
70888300|NCT00812929|141262958|SUPERIORITY||Mean Difference (Net)|2.53|STANDARD_ERROR_OF_MEAN|1.438|||TWO_SIDED|95.0|-0.31|5.37||||||||5.37|-0.31|
70888301|NCT00812929|141262959|SUPERIORITY||Mean Difference (Net)|2.52|STANDARD_ERROR_OF_MEAN|1.638|||TWO_SIDED|95.0|-0.72|5.75||||||2 Hours||5.75|-0.72|
70888302|NCT00812929|141262959|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|1.247|||TWO_SIDED|95.0|-2.34|2.58||||||9.5 Hours||2.58|-2.34|
70888303|NCT00812929|141262959|SUPERIORITY||Mean Difference (Net)|2.6|STANDARD_ERROR_OF_MEAN|1.637|||TWO_SIDED|95.0|-0.64|5.84||||||2 Hours||5.84|-0.64|
70888304|NCT00812929|141262959|SUPERIORITY||Mean Difference (Net)|0.76|STANDARD_ERROR_OF_MEAN|1.247|||TWO_SIDED|95.0|-1.7|3.22||||||9.5 Hours||3.22|-1.70|
70888305|NCT00812929|141262959|SUPERIORITY||Mean Difference (Net)|2.79|STANDARD_ERROR_OF_MEAN|1.639|||TWO_SIDED|95.0|-0.45|6.03||||||2 Hours||6.03|-0.45|
70888306|NCT00812929|141262959|SUPERIORITY||Mean Difference (Net)|3.49|STANDARD_ERROR_OF_MEAN|1.248|||TWO_SIDED|95.0|1.02|5.95||||||9.5 Hours||5.95|1.02|
70888307|NCT00812929|141262959|SUPERIORITY||Mean Difference (Net)|6.3|STANDARD_ERROR_OF_MEAN|1.637|||TWO_SIDED|95.0|3.06|9.54||||||2 Hours||9.54|3.06|
70888308|NCT00812929|141262959|SUPERIORITY||Mean Difference (Net)|2.27|STANDARD_ERROR_OF_MEAN|1.245|||TWO_SIDED|95.0|-0.19|4.73||||||9.5 Hours||4.73|-0.19|
70888309|NCT00812929|141262960|SUPERIORITY||Mean Difference (Net)|0.94|STANDARD_ERROR_OF_MEAN|1.17|||TWO_SIDED|95.0|-1.37|3.25|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|2 Hours||3.25|-1.37|
70888310|NCT00812929|141262960|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.878|||TWO_SIDED|95.0|-1.66|1.8|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|9.5 Hours||1.80|-1.66|
70888311|NCT00812929|141262960|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|0.873|||TWO_SIDED|95.0|-0.82|2.63|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|24 Hours||2.63|-0.82|
70888312|NCT00812929|141262960|SUPERIORITY||Mean Difference (Net)|1.12|STANDARD_ERROR_OF_MEAN|1.169|||TWO_SIDED|95.0|-1.19|3.43|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|2 Hours||3.43|-1.19|
70888313|NCT00812929|141262960|SUPERIORITY||Mean Difference (Net)|1.22|STANDARD_ERROR_OF_MEAN|0.878|||TWO_SIDED|95.0|-0.51|2.95|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|9.5 Hours||2.95|-0.51|
70888314|NCT00812929|141262960|SUPERIORITY||Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.873|||TWO_SIDED|95.0|-1.55|1.9|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|24 Hours||1.90|-1.55|
70888315|NCT00812929|141262960|SUPERIORITY||Mean Difference (Net)|1.51|STANDARD_ERROR_OF_MEAN|1.171|||TWO_SIDED|95.0|-0.8|3.82|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|2 Hours||3.82|-0.80|
70888316|NCT00812929|141262960|SUPERIORITY||Mean Difference (Net)|3.3|STANDARD_ERROR_OF_MEAN|0.879|||TWO_SIDED|95.0|1.57|5.03|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|9.5 Hours||5.03|1.57|
70888317|NCT00812929|141262960|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.874|||TWO_SIDED|95.0|-1.83|1.62|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|24 Hours||1.62|-1.83|
70888318|NCT00812929|141262960|SUPERIORITY||Mean Difference (Net)|3.17|STANDARD_ERROR_OF_MEAN|1.169|||TWO_SIDED|95.0|0.86|5.48|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|2 Hours||5.48|0.86|
70888319|NCT00812929|141262960|SUPERIORITY||Mean Difference (Net)|2.11|STANDARD_ERROR_OF_MEAN|0.877|||TWO_SIDED|95.0|0.38|3.84|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|9.5 Hours||3.84|0.38|
70888320|NCT00812929|141262960|SUPERIORITY||Mean Difference (Net)|1.72|STANDARD_ERROR_OF_MEAN|0.872|||TWO_SIDED|95.0|0.0|3.44|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|24 Hours||3.44|-0.00|
70888321|NCT00812929|141262961|SUPERIORITY||Hazard Ratio (HR)|1.25|||||TWO_SIDED|95.0|0.71|2.21|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|2 Hours||2.21|0.71|
70888322|NCT00812929|141262961|SUPERIORITY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.59|2.06|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|9.5 Hours||2.06|0.59|
70888323|NCT00812929|141262961|SUPERIORITY||Hazard Ratio (HR)|1.78|||||TWO_SIDED|95.0|0.93|3.43|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|24 Hours||3.43|0.93|
70888324|NCT00812929|141262961|SUPERIORITY||Hazard Ratio (HR)|1.42|||||TWO_SIDED|95.0|0.81|2.48|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|2 Hours||2.48|0.81|
70888325|NCT00812929|141262961|SUPERIORITY||Hazard Ratio (HR)|1.93|||||TWO_SIDED|95.0|1.01|3.66|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|9.5 Hours||3.66|1.01|
70888326|NCT00812929|141262961|SUPERIORITY||Hazard Ratio (HR)|1.67|||||TWO_SIDED|95.0|0.86|3.25|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|24 Hours||3.25|0.86|
70888327|NCT00812929|141262961|SUPERIORITY||Hazard Ratio (HR)|2.09|||||TWO_SIDED|95.0|1.19|3.69|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|2 Hours||3.69|1.19|
70888328|NCT00812929|141262961|SUPERIORITY||Hazard Ratio (HR)|5.49|||||TWO_SIDED|95.0|2.75|10.94|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|9.5 Hours||10.94|2.75|
70888329|NCT00812929|141262961|SUPERIORITY||Hazard Ratio (HR)|1.91|||||TWO_SIDED|95.0|1.0|3.64|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|24 Hours||3.64|1.00|
70888330|NCT00812929|141262961|SUPERIORITY||Hazard Ratio (HR)|3.6|||||TWO_SIDED|95.0|2.0|6.48|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|2 Hours||6.48|2.00|
70888331|NCT00812929|141262961|SUPERIORITY||Hazard Ratio (HR)|2.03|||||TWO_SIDED|95.0|1.07|3.87|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|9.5 Hours||3.87|1.07|
70888332|NCT00812929|141262961|SUPERIORITY||Hazard Ratio (HR)|6.07|||||TWO_SIDED|95.0|2.9|12.71|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|24 Hours||12.71|2.90|
70888333|NCT04713748|141262997|OTHER||||||<|0.0001|||||||Interclass correlation coefficient|||||||<0.0001
70888334|NCT00113516|141262999|SUPERIORITY_OR_OTHER||probability|0.405|||||TWO_SIDED|90.0|0.315|0.494|||Kaplan-Meier||The probability of survival along with the corresponding confidence interval (CI) (for the log \[-log (1-year survival rate)\]) was calculated using a normal approximation and then back transformed to give a CI for the 1-year survival rate itself.|The study was designed to test the null hypothesis that the true one-year probability of survival is 0.40 versus the alternative hypothesis that the true one-year probability of survival is at least 0.55. The sample size was determined using a One-Sample Survival design, assuming alpha=0.05 (1-sided), power= 0.90, 6 month accrual, a minimum follow-up period of 12 months, and an expectation that approximately 5% of subjects may be lost to follow-up.||0.494|0.315|
70888335|NCT00113516|141263003|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|27.4|||||TWO_SIDED|95.0|18.2|38.2||||||||38.2|18.2|
70888336|NCT00113516|141263017|SUPERIORITY_OR_OTHER|||||||0.474||95.0|||||Wilcoxon Rank Sum Test|||||||0.474
70888337|NCT00113516|141263018|SUPERIORITY_OR_OTHER|||||||0.836||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.836
70888338|NCT00113516|141263018|SUPERIORITY_OR_OTHER|||||||0.071||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.071
70888339|NCT00113516|141263018|SUPERIORITY_OR_OTHER|||||||0.393||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.393
70888340|NCT00113516|141263018|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.029
70888341|NCT00113516|141263018|SUPERIORITY_OR_OTHER|||||||0.247||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.247
70888342|NCT00113516|141263019|SUPERIORITY_OR_OTHER|||||||0.305||95.0|||||Wilcoxon Rank Sum Test|||||||0.305
70888343|NCT00113516|141263020|SUPERIORITY_OR_OTHER|||||||0.738||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.738
70888344|NCT00113516|141263020|SUPERIORITY_OR_OTHER|||||||0.438||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.438
70888345|NCT00113516|141263020|SUPERIORITY_OR_OTHER|||||||0.236||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.236
70888346|NCT00113516|141263020|SUPERIORITY_OR_OTHER|||||||0.287||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.287
70888347|NCT00113516|141263020|SUPERIORITY_OR_OTHER|||||||0.772||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.772
70888348|NCT00113516|141263021|SUPERIORITY_OR_OTHER|||||||0.537||95.0|||||Wilcoxon Rank Sum Test|||||||0.537
70888349|NCT00113516|141263022|SUPERIORITY_OR_OTHER|||||||0.813||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.813
70888350|NCT00113516|141263022|SUPERIORITY_OR_OTHER|||||||0.849||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.849
70888351|NCT00113516|141263022|SUPERIORITY_OR_OTHER|||||||0.121||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.121
70888352|NCT00113516|141263022|SUPERIORITY_OR_OTHER|||||||0.582||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.582
70888353|NCT00113516|141263022|SUPERIORITY_OR_OTHER|||||||0.383||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.383
70888354|NCT00113516|141263023|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.6782|TWO_SIDED|95.0|0.61|2.15|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||2.15|0.61|0.6782
70888355|NCT00113516|141263023|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.198|TWO_SIDED|95.0|0.77|3.3|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||3.30|0.77|0.1980
70888356|NCT00113516|141263023|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.8||||0.1344|TWO_SIDED|95.0|0.82|3.98|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||3.98|0.82|0.1344
70888357|NCT00113516|141263023|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.4809|TWO_SIDED|95.0|0.56|3.39|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||3.39|0.56|0.4809
70888358|NCT00113516|141263023|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.6||||0.0153|TWO_SIDED|95.0|1.19|11.13|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group|Cycle 3, Day 1||11.13|1.19|0.0153
70888359|NCT00113516|141263023|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.7||||0.2085|TWO_SIDED|95.0|0.52|14.37|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group|Cycle 3, Day 28||14.37|0.52|0.2085
70888360|NCT00113516|141263023|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.8084|TWO_SIDED|95.0|0.08|23.57|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group|Cycle 5, Day 28||23.57|0.08|0.8084
70888361|NCT00113516|141263024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.507|TWO_SIDED|95.0|0.65|2.39|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||2.39|0.65|0.5070
70888362|NCT00113516|141263024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.4474|TWO_SIDED|95.0|0.63|2.82|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||2.82|0.63|0.4474
70888363|NCT00113516|141263024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.7599|TWO_SIDED|95.0|0.4|1.95|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||1.95|0.40|0.7599
70888364|NCT00113516|141263024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.0109|TWO_SIDED|95.0|0.12|0.8|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||0.80|0.12|0.0109
70888365|NCT00113516|141263024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.6878|TWO_SIDED|95.0|0.43|3.58|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||3.58|0.43|0.6878
70888366|NCT00113516|141263024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.7||||0.4637|TWO_SIDED|95.0|0.38|8.12|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||8.12|0.38|0.4637
70888367|NCT00113516|141263025|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.5277|TWO_SIDED|95.0|0.39|1.62|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||1.62|0.39|0.5277
70888368|NCT00113516|141263025|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.466|TWO_SIDED|95.0|0.58|3.29|||Log Rank||HR was based upon the ratio of \>=Median Cutpoint group hazard to \<Median Cutpoint group.|Cycle 1, Day 28||3.29|0.58|0.4660
70888369|NCT00113516|141263025|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.5337|TWO_SIDED|95.0|0.52|3.44|||Log Rank||HR was based upon the ratio of \>=Median Cutpoint group hazard to \<Median Cutpoint group.|Cycle 2, Day 1||3.44|0.52|0.5337
70888370|NCT00113516|141263025|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||0.0712|TWO_SIDED|95.0|0.13|1.13|||Log Rank||HR was based upon the ratio of \>=Median Cutpoint group hazard to \<Median Cutpoint group.|Cycle 2, Day 28||1.13|0.13|0.0712
70888371|NCT00113516|141263025|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.0||||0.2948|TWO_SIDED|95.0|0.54|7.07|||Log Rank||HR was based upon the ratio of \>=Median Cutpoint group hazard to \<Median Cutpoint group.|Cycle 3, Day 1||7.07|0.54|0.2948
70888372|NCT00113516|141263025|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.3||||0.32|TWO_SIDED|95.0|0.28|38.48|||Log Rank||HR was based upon the ratio of \>=Median Cutpoint group hazard to \<Median Cutpoint group.|Cycle 3, Day 28||38.48|0.28|0.3200
70888373|NCT00113516|141263026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.7824|TWO_SIDED|95.0|0.56|2.17|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||2.17|0.56|0.7824
70888374|NCT00113516|141263026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.1918|TWO_SIDED|95.0|0.77|3.47|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||3.47|0.77|0.1918
70888375|NCT00113516|141263026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.9||||0.1093|TWO_SIDED|95.0|0.85|4.3|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||4.30|0.85|0.1093
70888376|NCT00113516|141263026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.4809|TWO_SIDED|95.0|0.56|3.39|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||3.39|0.56|0.4809
70888377|NCT00113516|141263026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.2||||0.011|TWO_SIDED|95.0|1.26|13.85|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||13.85|1.26|0.0110
70888378|NCT00113516|141263026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.7||||0.2085|TWO_SIDED|95.0|0.52|14.37|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||14.37|0.52|0.2085
70888379|NCT00113516|141263026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.8084|TWO_SIDED|95.0|0.08|23.57|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 5, Day 28||23.57|0.08|0.8084
70888380|NCT00113516|141263027|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.5215|TWO_SIDED|95.0|0.62|2.53|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||2.53|0.62|0.5215
70888381|NCT00113516|141263027|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.2504|TWO_SIDED|95.0|0.72|3.49|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||3.49|0.72|0.2504
70888382|NCT00113516|141263027|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.8766|TWO_SIDED|95.0|0.42|2.11|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||2.11|0.42|0.8766
70888383|NCT00113516|141263027|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.0109|TWO_SIDED|95.0|0.12|0.8|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||0.80|0.12|0.0109
70888384|NCT00113516|141263027|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.5627|TWO_SIDED|95.0|0.46|4.18|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||4.18|0.46|0.5627
70888385|NCT00113516|141263027|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.7||||0.4637|TWO_SIDED|95.0|0.38|8.12|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||8.12|0.38|0.4637
70888386|NCT00113516|141263028|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.6682|TWO_SIDED|95.0|0.39|1.84|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||1.84|0.39|0.6682
70888387|NCT00113516|141263028|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.6854|TWO_SIDED|95.0|0.49|3.0|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||3.00|0.49|0.6854
70888388|NCT00113516|141263028|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.6028|TWO_SIDED|95.0|0.49|3.37|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||3.37|0.49|0.6028
70888389|NCT00113516|141263028|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||0.0712|TWO_SIDED|95.0|0.13|1.13|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||1.13|0.13|0.0712
70888390|NCT00113516|141263028|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.9||||0.3411|TWO_SIDED|95.0|0.5|7.15|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||7.15|0.50|0.3411
70888391|NCT00113516|141263028|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.3||||0.32|TWO_SIDED|95.0|0.28|38.48|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||38.48|0.28|0.3200
70888392|NCT00113516|141263029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.4768|TWO_SIDED|95.0|0.7|2.17|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||2.17|0.70|0.4768
70888393|NCT00113516|141263029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.1484|TWO_SIDED|95.0|0.84|3.13|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||3.13|0.84|0.1484
70888394|NCT00113516|141263029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.8957|TWO_SIDED|95.0|0.5|2.18|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||2.18|0.50|0.8957
70888395|NCT00113516|141263029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.5681|TWO_SIDED|95.0|0.33|1.85|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||1.85|0.33|0.5681
70888396|NCT00113516|141263029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.8||||0.0074|TWO_SIDED|95.0|1.35|10.88|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||10.88|1.35|0.0074
70888397|NCT00113516|141263029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.1637|TWO_SIDED|95.0|0.06|1.7|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||1.70|0.06|0.1637
70888398|NCT00113516|141263029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.6||||0.4328|TWO_SIDED|95.0|0.23|29.12|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 5, Day 28||29.12|0.23|0.4328
70888399|NCT00113516|141263030|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.4269|TWO_SIDED|95.0|0.72|2.21|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||2.21|0.72|0.4269
70888400|NCT00113516|141263030|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.929|TWO_SIDED|95.0|0.51|1.86|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||1.86|0.51|0.9290
70888401|NCT00113516|141263030|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.8195|TWO_SIDED|95.0|0.44|1.91|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||1.91|0.44|0.8195
70888402|NCT00113516|141263030|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.221|TWO_SIDED|95.0|0.26|1.38|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||1.38|0.26|0.2210
70888403|NCT00113516|141263030|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.4297|TWO_SIDED|95.0|0.24|1.85|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||1.85|0.24|0.4297
70888404|NCT00113516|141263030|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.0522|TWO_SIDED|95.0|0.06|1.11|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||1.11|0.06|0.0522
70888405|NCT00113516|141263030|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.6949|TWO_SIDED|95.0|0.05|7.0|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 5, Day 28||7.00|0.05|0.6949
70888406|NCT00113516|141263031|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.766|TWO_SIDED|95.0|0.51|1.65|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||1.65|0.51|0.7660
70888407|NCT00113516|141263031|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.5||||0.2682|TWO_SIDED|95.0|0.72|3.23|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||3.23|0.72|0.2682
70888408|NCT00113516|141263031|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.2726|TWO_SIDED|95.0|0.69|3.7|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||3.70|0.69|0.2726
70888409|NCT00113516|141263031|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.2787|TWO_SIDED|95.0|0.22|1.55|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||1.55|0.22|0.2787
70888410|NCT00113516|141263031|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.4||||0.0241|TWO_SIDED|95.0|1.09|17.56|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||17.56|1.09|0.0241
70888411|NCT00113516|141263031|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.4||||0.0943|TWO_SIDED|95.0|0.59|48.81|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||48.81|0.59|0.0943
70888412|NCT00113516|141263031|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.8084|TWO_SIDED|95.0|0.04|11.79|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 5, Day 28||11.79|0.04|0.8084
70888413|NCT00812812|141263059|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.6||||0.198|TWO_SIDED|95.0|-11.7|2.5|||ANCOVA||Mean difference was estimated as paroxetine minus placebo.|||2.5|-11.7|0.198
70888414|NCT03091751|141263071|OTHER||Mean Difference (Final Values)|10.41||||0.77|TWO_SIDED|95.0|-224.88|245.7|||t-test, 1 sided|||||245.70|-224.88|0.77
70888415|NCT03091751|141263072|OTHER||Mean Difference (Final Values)|0.3068||||0.002|TWO_SIDED|95.0|0.1501|0.4635|||t-test, 1 sided|||||0.4635|0.1501|0.002
70888416|NCT03091751|141263073|OTHER||Mean Difference (Final Values)|-3.3||||0.3|TWO_SIDED|95.0|-8.9|2.3|||t-test, 1 sided|||||2.3|-8.9|0.30
70888417|NCT03091751|141263074|OTHER||Mean Difference (Final Values)|-0.0058||||0.16|TWO_SIDED|95.0|-0.0119|0.0003|||t-test, 1 sided|||||0.0003|-0.0119|0.16
70888418|NCT03091751|141263075|OTHER||Mean Difference (Final Values)|-7.609||||0.02|TWO_SIDED|95.0|-13.344|-1.879|||t-test, 1 sided|||||-1.879|-13.344|0.02
70888419|NCT01161329|141263077|NON_INFERIORITY_OR_EQUIVALENCE|It was estimated that 128 individuals would be required for 80 % Power with a type I error of 5% to detect a 2-point difference in BBS with a standard deviation of +/- 4 points. Because of the slow recruitment and the statistically significant improvements observed in the primary outcome in the intervention group during an interim analysis the study was finalized with fewer participants than had been initially calculated.||||||0.001||||||The Bonferroni method was used to assess longitudinal Changes and correct for multiple comparisons, with significance set at p\<0.016 to minimize the risk for type I errors.|Wilcoxon (Mann-Whitney)|||Intention-to-treat analysis was performed to assess the effects on the outcome measures. Between-group differences for all outcome measures were analyzed using Mann-Whitney U-test.||||0.001
70888420|NCT01161329|141263078|SUPERIORITY_OR_OTHER|||||||0.09||||||The p-value for the man differnece in SPPB between grpoups att three months was 0.09|Wilcoxon (Mann-Whitney)|||||||0.09
70888421|NCT00678691|141263079|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||all p-values come from one model analysis and are therefore included in free text as such|piecewise model|A piecewise statistical model results for between group differences: P=.390 (baseline through week 5), p=.775 (week 5 - week 8||Authors expected armodafinal to work better than placebo reducing BFI scale scores by 30%. A piecewise statistical model was used to compare baseline scores against those over through week 8. Piecewise results for between group differences for BFI Scores: P=.390 (baseline through week 5), p=.775 (week 5 - week 8).||||<0.05
70888422|NCT01599650|141263084|SUPERIORITY_OR_OTHER||difference in LS mean|10.0|STANDARD_ERROR_OF_MEAN|1.41|<|0.0001|TWO_SIDED|95.0|7.3|12.8|||ANOVA|||||12.8|7.3|<0.0001
70888423|NCT01599650|141263084|SUPERIORITY_OR_OTHER||difference in LS Means|8.7|STANDARD_ERROR_OF_MEAN|1.46|<|0.0001|TWO_SIDED|95.0|5.8|11.6|||ANOVA|||||11.6|5.8|<0.0001
70888424|NCT03402243|141263095|SUPERIORITY||Estimated mean ratio|1.38|||||TWO_SIDED|95.0|1.1|1.75|||||Baseline adjusted model estimated mean ratio in cigarettes smoked per day of those randomized to a total menthol ban smoked relative to those randomized to a menthol cigarette ban|||1.75|1.1|
70888425|NCT03402243|141263095|SUPERIORITY||Estimated mean ratio|0.87|||||TWO_SIDED|95.0|0.68|1.11|||||Baseline adjusted model estimated mean ratio in cigarettes smoked per day of those randomized to a menthol cigarettes ban relative to those randomized to no menthol ban|||1.11|0.68|
70888426|NCT03402243|141263095|SUPERIORITY||Estimated mean ratio|1.2|||||TWO_SIDED|95.0|0.99|1.45|||||Baseline adjusted model estimated mean ratio in cigarettes smoked per day of those randomized to a menthol ban for cigarettes and e-cigarettes relative to those randomized to no menthol ban|||1.45|0.99|
70888427|NCT03402243|141263095|SUPERIORITY|||||||0.349|||||||Kruskal-Wallis|||Average number of puffs per participants over the 6 week study period||||0.349
70888428|NCT03402243|141263096|SUPERIORITY|||||||0.185|||||||Mixed Models Analysis|||Comparison among groups in number of cigarette packs selected||||0.185
70888429|NCT03402243|141263096|SUPERIORITY|||||||0.076|||||||Mixed Models Analysis|||Comparison among groups in number of e-cigarette liquid units selected||||0.076
70888430|NCT03402243|141263097|SUPERIORITY|||||||0.27|||||||Mixed Models Analysis|||||||0.27
70888431|NCT00684424|141263100|SUPERIORITY_OR_OTHER_LEGACY||R-ratio|-56.723|STANDARD_DEVIATION|46.9499||||95.0|||||summary statistic|||R-ratio of seizure frequency summaries = \[(t-b)/(t+b)\]\*100; where t= treatment seizure frequency and b= baseline seizure frequency.||||
70888432|NCT04154631|141263123|SUPERIORITY||Time by treatment interaction coeff.|-10.91|||<|0.001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Immediate TranS-C (Standard/Adapted combined) versus UC-DT on change in sleep disturbance from pre to post.||||<0.001
70888433|NCT04154631|141263123|SUPERIORITY||Coefficient of indirect effect|0.17||||0.95|TWO_SIDED|95.0|-4.62|4.95|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at post was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||4.95|-4.62|0.95
70888434|NCT04154631|141263123|SUPERIORITY||Coefficient of indirect effect|0.09||||0.95|TWO_SIDED|95.0|-2.39|2.56|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at 6-month follow-up was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||2.56|-2.39|0.95
70888435|NCT04154631|141263123|SUPERIORITY||Coefficient of indirect effect|-0.16||||0.88|TWO_SIDED|95.0|-2.31|1.98|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at post was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||1.98|-2.31|0.88
70888436|NCT04154631|141263123|SUPERIORITY||Coefficient of indirect effect|-0.13||||0.88|TWO_SIDED|95.0|-3.1|2.31|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at 6-month follow-up was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||2.31|-3.10|0.88
70888437|NCT04154631|141263123|SUPERIORITY||Coefficient of indirect effect|-0.5||||0.79|TWO_SIDED|95.0|-2.18|1.66|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at post was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||1.66|-2.18|0.79
70888438|NCT04154631|141263123|SUPERIORITY||Coefficient of indirect effect|-0.26||||0.79|TWO_SIDED|95.0|-2.18|1.66|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at 6-month follow-up was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||1.66|-2.18|0.79
70888439|NCT04154631|141263124|SUPERIORITY||time by treatment interaction coeff.|-0.03||||0.77|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment effect (Standard versus Adapted TranS-C) on change in Acceptability Intervention Measure (AIM) from baseline (post-training) to post-treatment.||||0.77
70888440|NCT04154631|141263125|SUPERIORITY||Time by treatment interaction coeff.|-9.52|||<|0.001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment condition (Standard/Adapted TranS-C versus UC-DT) on change in sleep-related impairment from pre to post.||||<0.001
70888441|NCT04154631|141263125|SUPERIORITY||Coefficient of indirect effect|0.26||||0.92|TWO_SIDED|95.0|-5.04|5.56|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at post was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||5.56|-5.04|0.92
70888442|NCT04154631|141263125|SUPERIORITY||Coefficient of indirect effect|0.1||||0.92|TWO_SIDED|95.0|-2.04|2.24|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at 6-month follow-up was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||2.24|-2.04|0.92
70888443|NCT04154631|141263125|SUPERIORITY||Coefficient of indirect effect|-0.39||||0.78|TWO_SIDED|95.0|-3.1|2.31|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at post was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||2.31|-3.10|0.78
70888444|NCT04154631|141263125|SUPERIORITY||Coefficient of indirect effect|-0.3||||0.78|TWO_SIDED|95.0|-2.35|1.75|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at 6-month follow-up was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||1.75|-2.35|0.78
70888445|NCT04154631|141263125|SUPERIORITY||Coefficient of indirect effect|-0.43||||0.84|TWO_SIDED|95.0|-4.66|3.8|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at post was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||3.80|-4.66|0.84
70888446|NCT04154631|141263125|SUPERIORITY||Coefficient of indirect effect|-0.18||||0.84|TWO_SIDED|95.0|-1.94|1.58|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at 6-month follow-up was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||1.58|-1.94|0.84
70888447|NCT04154631|141263126|SUPERIORITY||Time by treatment interaction coeff.|1.63|||<|0.001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment condition (Standard/Adapted TranS-C versus UC-DT) on change in Composite Sleep Health Score from pre to post.||||<0.001
70888448|NCT04154631|141263127|SUPERIORITY||Time by treatment interaction coeff.|-5.12|||<|0.001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment condition (Standard/Adapted TranS-C versus UC-DT) on change in functional impairment from pre to post.||||<0.001
70888449|NCT04154631|141263127|SUPERIORITY||Coefficient of indirect effect|-3.12|||<|0.001|TWO_SIDED|95.0|-4.58|-1.66|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between TranS-C condition (Immediate vs. UC-DT) and functional impairment (Sheehan Disability Scale) at post was mediated by sleep disturbance (PROMIS-SD) at post. The parameter of interest was the indirect effect.||-1.66|-4.58|<0.001
70888450|NCT04154631|141263127|SUPERIORITY||Coefficient of indirect effect|-3.81|||<|0.001|TWO_SIDED|95.0|-5.41|-2.22|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between TranS-C condition (Immediate vs. UC-DT) and functional impairment (Sheehan Disability Scale) at post was mediated by sleep-related impairment (PROMIS-SRI). The parameter of interest was the indirect effect at post||-2.22|-5.41|<0.001
70888451|NCT04154631|141263127|SUPERIORITY||Coefficient of indirect effect|0.07||||0.94|TWO_SIDED|95.0|-1.78|1.92|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at post was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||1.92|-1.78|0.94
70888452|NCT04154631|141263127|SUPERIORITY||Coefficient of indirect effect|0.05||||0.94|TWO_SIDED|95.0|-1.16|1.25|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at 6-month follow-up was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||1.25|-1.16|0.94
70888453|NCT04154631|141263127|SUPERIORITY||Coefficient of indirect effect|0.03||||0.85|TWO_SIDED|95.0|-0.3|0.37|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at post was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||0.37|-0.30|0.85
70888454|NCT04154631|141263127|SUPERIORITY||Coefficient of indirect effect|-0.23||||0.7|TWO_SIDED|95.0|-1.41|0.95|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at 6-month follow-up was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||0.95|-1.41|0.70
70888455|NCT04154631|141263127|SUPERIORITY||Coefficient of indirect effect|0.01||||0.92|TWO_SIDED|95.0|-0.23|0.25|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at post was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||0.25|-0.23|0.92
70888456|NCT04154631|141263127|SUPERIORITY||Coefficient of indirect effect|-0.07||||0.82|TWO_SIDED|95.0|-0.68|0.54|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at 6-month follow-up was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||0.54|-0.68|0.82
70888457|NCT04154631|141263128|SUPERIORITY||Time by treatment interaction coeff.|-6.72|||<|0.001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment condition (Standard/Adapted TranS-C versus UC-DT) on change in psychiatric symptoms from pre to post.||||<0.001
70888458|NCT04154631|141263128|SUPERIORITY||Coefficient of indirect effect|-1.86||||0.08|TWO_SIDED|95.0|-3.93|-0.21|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between TranS-C condition (Immediate vs. UC-DT) and psychiatric symptoms (Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at post was mediated by sleep disturbance (PROMIS-SD) at post. The parameter of interest was the indirect effect.||-0.21|-3.93|0.08
70888459|NCT04154631|141263128|SUPERIORITY||Coefficient of indirect effect|-2.51||||0.02|TWO_SIDED|95.0|-4.58|-0.44|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between TranS-C condition (Immediate vs. UC-DT) and psychiatric symptoms (Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at post was mediated by sleep-related impairment (PROMIS-SRI) at post. The parameter of interest was the indirect effect.||-0.44|-4.58|0.02
70888460|NCT04154631|141263128|SUPERIORITY||Coefficient of indirect effect|0.05||||0.97|TWO_SIDED|95.0|-1.99|2.08|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at post was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||2.08|-1.99|0.97
70888461|NCT04154631|141263128|SUPERIORITY||Coefficient of indirect effect|0.004||||0.97|TWO_SIDED|95.0|-0.18|0.19|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at 6-month follow-up was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||0.19|-0.18|0.97
70888462|NCT04154631|141263128|SUPERIORITY||Coefficient of indirect effect|0.02||||0.9|TWO_SIDED|95.0|-0.27|0.3|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at post was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||0.30|-0.27|0.90
70888463|NCT04154631|141263128|SUPERIORITY||Coefficient of indirect effect|0.01||||0.94|TWO_SIDED|95.0|-0.19|0.2|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at 6-month follow-up was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||0.20|-0.19|0.94
70888464|NCT04154631|141263128|SUPERIORITY||Coefficient of indirect effect|-0.19||||0.8|TWO_SIDED|95.0|-1.67|1.28|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at post was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||1.28|-1.67|0.80
70888465|NCT04154631|141263128|SUPERIORITY||Coefficient of indirect effect|-0.04||||0.77|TWO_SIDED|95.0|-0.33|0.25|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at 6-month follow-up was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||0.25|-0.33|0.77
70888466|NCT04154631|141263129|SUPERIORITY||time by treatment interaction coeff.|-0.01||||0.94|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment effect (Standard versus Adapted TranS-C) on change in Intervention Appropriateness Measure (IAM) from baseline (post-training) to post-treatment.||||0.94
70888467|NCT04154631|141263130|SUPERIORITY||Time by treatment interaction coeff.|-0.11||||0.34|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment effect (Standard versus Adapted TranS-C) on change in Feasibility of Intervention Measure (FIM) from baseline (post-training) to post-treatment.||||0.34
70888468|NCT01032135|141263154|OTHER|||||||0.11|||||||Chi-squared|||||||0.11
70888469|NCT01032135|141263155|OTHER|||||||0.02|||||||Chi-squared|||||||0.02
70888470|NCT01032135|141263156|OTHER|||||||0.005|||||||Chi-squared|||||||0.005
70888471|NCT01032135|141263161|OTHER||Odds Ratio (OR)|0.4||||0.0007|TWO_SIDED|95.0|0.23|0.68|||Chi-squared|||The statistical analyses used data from all follow up assessments.||0.68|0.23|0.0007
70888472|NCT01032135|141263161|OTHER||Odds Ratio (OR)|0.54||||0.16|TWO_SIDED|95.0|0.23|1.27|||Chi-squared|||The statistical analyses used data from all follow up assessments.||1.27|0.23|0.16
70888473|NCT01032135|141263161|OTHER||Odds Ratio (OR)|1.12||||0.79|TWO_SIDED|95.0|0.48|2.6|||Chi-squared|||The statistical analyses used data from all follow up assessments.||2.60|0.48|0.79
70888474|NCT01032135|141263166|OTHER||Odds Ratio (OR)|-1.08||||0.009|TWO_SIDED|95.0|-1.87|-0.29|||Chi-squared|||The statistical analyses used data from all follow up assessments.||-0.29|-1.87|0.009
70888475|NCT01032135|141263166|OTHER||Odds Ratio (OR)|-0.84||||0.23|TWO_SIDED|95.0|-2.2|0.52|||Chi-squared|||The statistical analyses used data from all follow up assessments.||0.52|-2.20|0.23
70888476|NCT01032135|141263166|OTHER||Odds Ratio (OR)|-0.34||||0.58|TWO_SIDED|95.0|-1.52|0.85|||Chi-squared|||The statistical analyses used data from all follow up assessments.||0.85|-1.52|0.58
70888477|NCT01032135|141263171|OTHER||Odds Ratio (OR)|0.33||||0.0001|TWO_SIDED|95.0|0.19|0.58|||Chi-squared|||The statistical analyses used data from all follow up assessments.||0.58|0.19|0.0001
70888478|NCT01032135|141263171|OTHER||Odds Ratio (OR)|0.67||||0.36|TWO_SIDED|95.0|0.29|1.54|||Chi-squared|||The statistical analyses used data from all follow up assessments.||1.54|0.29|0.36
70888479|NCT01032135|141263171|OTHER||Odds Ratio (OR)|1.43||||0.45|TWO_SIDED|95.0|0.58|3.54|||Chi-squared|||The statistical analyses used data from all follow up assessments.||3.54|0.58|0.45
70888480|NCT01032135|141263176|OTHER||Odds Ratio (OR)|-1.09||||0.003|TWO_SIDED|95.0|-1.8|-0.39|||Chi-squared|||The statistical analyses used data from all follow up assessments.||-0.39|-1.80|0.003
70888481|NCT01032135|141263176|OTHER||Odds Ratio (OR)|0.02||||0.1|TWO_SIDED|95.0|-1.1|1.14|||Chi-squared|||The statistical analyses used data from all follow up assessments.||1.14|-1.10|0.10
70888482|NCT01032135|141263180|OTHER||Odds Ratio (OR)|0.66||||0.13|TWO_SIDED|95.0|0.38|1.14|||Chi-squared|||The statistical analyses used data from all follow up assessments.||1.14|0.38|0.13
70888483|NCT01032135|141263180|OTHER||Odds Ratio (OR)|0.83||||0.71|TWO_SIDED|95.0|0.33|2.12|||Chi-squared|||The statistical analyses used data from all follow up assessments.||2.12|0.33|0.71
70888484|NCT01032135|141263180|OTHER||Odds Ratio (OR)|1.48||||0.36|TWO_SIDED|95.0|0.64|3.4|||Chi-squared|||The statistical analyses used data from all follow up assessments.||3.40|0.64|0.36
70888485|NCT01032135|141263183|OTHER||Odds Ratio (OR)|-0.13||||0.75|TWO_SIDED|95.0|-0.94|0.6|||Chi-squared|||The statistical analyses used data from all follow up assessments.||0.60|-0.94|0.75
70888486|NCT01032135|141263183|OTHER||Odds Ratio (OR)|-0.84||||0.16|TWO_SIDED|95.0|-1.98|0.3|||Chi-squared|||The statistical analyses used data from all follow up assessments.||0.30|-1.98|0.16
70888487|NCT01032135|141263183|OTHER||Odds Ratio (OR)|0.6||||0.42|TWO_SIDED|95.0|-0.85|2.04|||Chi-squared|||The statistical analyses used data from all follow up assessments.||2.04|-0.85|0.42
70888488|NCT00853658|141263212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.1724|TWO_SIDED|95.0|0.85|1.03|||Regression, Cox|||(superiority)||1.03|0.85|0.1724
70888489|NCT00853658|141263212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.4579|TWO_SIDED|95.0|0.85|1.07|||Regression, Cox|||(superiority) Non-Diabetic patients||1.07|0.85|0.4579
70888490|NCT00853658|141263212|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified Non-inferiority margin 1.104 is used.|Hazard Ratio (HR)|0.99||||0.0368|TWO_SIDED|95.0|0.9|1.1|||Regression, Cox|||||1.10|0.90|0.0368
70888491|NCT00853658|141263212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.9118|TWO_SIDED|95.0|0.9|1.1|||Regression, Cox|||(superiority)||1.10|0.90|0.9118
70888492|NCT03246529|141263219|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified Cochran-Mantel-Haenszel (CMH) test (by response status and baseline platelet count),||||||<0.0001
70888493|NCT03246529|141263220|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70888494|NCT03246529|141263221|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70888495|NCT03117387|141263259|OTHER|Bland-Altman analysis estimates bias between TOF-Cuff and electromyography.|bias|0.0|||||TWO_SIDED|0.05|-0.05|0.05||||||"Paired measurements were compared using a Bland-Altman analysis modified for repeated measurements (http://sec.lumc.nl/method\_agreement\_analysis, Leiden, the Netherlands).~This Bland-Altman analysis corrects for between subject variability of repeated paired measurements in individual subjects."||0.05|-0.05|
70888496|NCT06748040|141263280|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.4852|TWO_SIDED|95.0|-2.4|1.2||P-value less than 0.05 is considered as statistically significant.|t-test, 2 sided|||||1.2|-2.4|0.4852
70963582|NCT03531788|141432066|OTHER|||||||||||||||||Activity counts from the ActiGraph GT9x activity monitor were collected during baseline (without a device) and throughout the 4 week device trial (with the device). For each time period, activity count data were averaged across the day. We then compared the baseline time period to the device trial period to understand the difference in movement and upper extremity positioning during the device trial. Data presented are within group change scores and not between group data comparisons.|Counts from each axis (x, y, z) were measured across baseline and during the 4-week trial to explore arm movement and positioning during the use of an upper extremity arm device. Counts (within each participant) were summed. A change score from trial minus baseline was calculated for each axis. We provide an average change score and standard deviation across participants with Kinova and participants with WREX.|||
70888497|NCT00320281|141263281|SUPERIORITY_OR_OTHER_LEGACY|||||||0.432||95.0|||||ANCOVA|||||||0.432
70888498|NCT01856140|141263283|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at baseline||||0.52
70888499|NCT01856140|141263283|OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 6 weeks.||||0.47
70888500|NCT01856140|141263283|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 12 weeks.||||0.52
70888501|NCT01856140|141263284|OTHER|||||||0.227|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at baseline||||0.227
70888502|NCT01856140|141263284|OTHER|||||||0.573|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 6 weeks.||||0.573
70888503|NCT01856140|141263284|OTHER|||||||0.588|||||||Wilcoxon (Mann-Whitney)|||||||0.588
70888504|NCT01856140|141263285|OTHER|||||||0.262|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at baseline||||0.262
70888505|NCT01856140|141263285|OTHER|||||||0.631|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 6 weeks.||||0.631
70888506|NCT01856140|141263285|OTHER|||||||0.796|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 12 weeks.||||0.796
70888507|NCT01856140|141263286|OTHER|||||||0.337|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at baseline||||0.337
70888508|NCT01856140|141263286|OTHER|||||||0.078|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 6 weeks||||0.078
70888509|NCT01856140|141263286|OTHER|||||||0.439|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 12 weeks.||||0.439
70888510|NCT00827372|141263287|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0658|||||||t-test, 2 sided|||With a sample size of 14 evaluable subjects, we will have 80% power to detect a change in excess arm volume of .8 standard deviations using a two-sided paired t-test. We will have 90% power to detect a difference of .9 standard deviations. A Paired T-Test was used to test the difference in arm volume from the second baseline measurement to Cycle 2 only.||||0.0658
70888511|NCT00827372|141263288|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0061|||||||t-test, 2 sided|||A Paired T-Test was used to compare the IFP affected at first versus affected at last reading.||||0.0061
70888512|NCT00827372|141263289|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0143|||||||t-test, 2 sided|||A Paired T-Test was used for the difference in the impedance ratio from the second baseline to cycle 2, day 1||||0.0143
70888513|NCT04011475|141263296|OTHER|||||||0.0276|||||||Log Rank|||||||0.0276
70888514|NCT04011475|141263296|OTHER||Hazard Ratio (HR)|0.875||||0.6665|TWO_SIDED|95.0|0.47|1.604|||Regression, Cox||Hazard Ratio (HR) was from Cox regression comparing group A versus group B using group B as reference.|||1.604|0.47|0.6665
70888515|NCT04011475|141263296|OTHER||Hazard Ratio (HR)|2.377||||0.031|TWO_SIDED|95.0|1.083|5.221|||Regression, Cox||Hazard Ratio (HR) was from Cox regression comparing group A versus group C using group C as reference.|||5.221|1.083|0.0310
70888516|NCT04011475|141263296|OTHER||Hazard Ratio (HR)|2.716||||0.0116|TWO_SIDED|95.0|1.25|5.901|||Regression, Cox||Hazard Ratio (HR) was from Cox regression comparing group B versus group C using group C as reference.|||5.901|1.250|0.0116
70888517|NCT04011475|141263297|OTHER||Rate ratio|0.67||||0.0756|TWO_SIDED|95.0|0.43|1.04|||Z-test||The rate ratio was from Poisson regression for Group A versus Group B using Group B as the reference group.|||1.04|0.43|0.0756
70888518|NCT04011475|141263297|OTHER||Rate ratio|4.36|||<|0.0001|TWO_SIDED|95.0|2.27|8.4|||Z-test||The rate ratio was from Poisson regression for Group B versus Group C using Group C as the reference group.|||8.40|2.27|< 0.0001
70888519|NCT04011475|141263297|OTHER||Rate ratio|0.34||||0.0022|TWO_SIDED|95.0|0.17|0.68|||Z-test||The rate ratio was from Poisson regression for Group C versus Group A using Group A as the reference group.|||0.68|0.17|0.0022
70888520|NCT04011475|141263298|OTHER||Rate ratio|1.25||||0.7394|TWO_SIDED|95.0|0.34|4.65|||Z-test||The rate ratio was from Poisson regression for Group B versus Group C using Group C as the reference group.|||4.65|0.34|0.7394
70888521|NCT04011475|141263299|OTHER||Rate ratio|0.65||||0.1116|TWO_SIDED|95.0|0.38|1.11|||Z-test||The rate ratio was from Poisson regression for Group A versus Group B using Group B as the reference group.|||1.11|0.38|0.1116
70888522|NCT04011475|141263299|OTHER||Rate ratio|3.78||||0.0004|TWO_SIDED|95.0|1.81|7.88|||Z-test||The rate ratio was from Poisson regression for Group B versus Group C using Group C as the reference group.|||7.88|1.81|0.0004
70888523|NCT04011475|141263299|OTHER||Rate ratio|0.41||||0.0239|TWO_SIDED|95.0|0.19|0.89|||Z-test||The rate ratio was from Poisson regression for Group C versus Group A using Group A as the reference group.|||0.89|0.19|0.0239
70888524|NCT04011475|141263300|OTHER||Rate ratio|0.71||||0.4164|TWO_SIDED|95.0|0.32|1.61|||Z-test||The rate ratio was from Poisson regression for Group A versus Group B using Group B as the reference group.|||1.61|0.32|0.4164
70888525|NCT04011475|141263300|OTHER||Rate ratio|7.0||||0.01|TWO_SIDED|95.0|1.59|30.8|||Z-test||The rate ratio was from Poisson regression for Group B versus Group C using Group C as the reference group.|||30.8|1.59|0.0100
70888526|NCT04011475|141263300|OTHER||Rate ratio|0.2||||0.0377|TWO_SIDED|95.0|0.04|0.91|||Z-test||The rate ratio was from Poisson regression for Group C versus Group A using Group A as the reference group.|||0.91|0.04|0.0377
70888527|NCT04011475|141263301|OTHER|||||||0.2035|||||||Log Rank|||||||0.2035
70888528|NCT04011475|141263302|OTHER|||||||0.1858|||||||Chi-squared|Chi-square test was applied for assessing the inter-group difference.||||||0.1858
70888529|NCT04011475|141263303|OTHER|||||||0.0144|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.0144
70888530|NCT04011475|141263303|OTHER|||||||0.9219|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.9219
70888531|NCT04011475|141263303|OTHER|||||||0.959|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.9590
70888532|NCT04011475|141263304|OTHER|||||||0.2909|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.2909
70888533|NCT04011475|141263304|OTHER|||||||0.1618|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.1618
70888534|NCT04011475|141263304|OTHER|||||||0.4695|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.4695
70888535|NCT04011475|141263305|OTHER||||||>|0.9999|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||> 0.9999
70888536|NCT04011475|141263305|OTHER|||||||0.2516|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.2516
70888537|NCT04011475|141263305|OTHER|||||||0.0036|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.0036
70888538|NCT04011475|141263306|OTHER|||||||0.6189|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was used for assessing the intra-group difference.||||||0.6189
70888539|NCT04011475|141263306|OTHER|||||||0.7656|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was used for assessing the intra-group difference.||||||0.7656
70888540|NCT04011475|141263306|OTHER|||||||0.3594|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was used for assessing the intra-group difference.||||||0.3594
70888541|NCT04011475|141263307|OTHER|||||||0.0483|||||||Chi-squared|Chi-square test was applied for assessing the inter-group difference.||||||0.0483
70888542|NCT05036642|141263330|OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Difference in measurements from 'no device' (baseline) to 'with device.'||||0.02
70888543|NCT05036642|141263331|OTHER|||||||0.01|||||||ANOVA|||Difference in measurements from 'no device' (baseline) to 'with device.'||||0.01
70888544|NCT05036642|141263332|OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Difference in measurements from 'no device' (baseline) to 'with device.'||||0.48
70888545|NCT00630877|141263337|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
70888546|NCT00630877|141263339|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Spearman rank-order correlation|||||||<0.0001
70888547|NCT00630877|141263340|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Spearman rank-order correlation|||||||<0.0001
70888548|NCT00630877|141263341|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Spearman rank-order correlation|||||||<0.0001
70888549|NCT00630877|141263342|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Spearman rank-order correlation|||||||<0.0001
70888550|NCT00630877|141263343|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Independent groups t-test|||||||0.002
70888551|NCT00630877|141263344|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Independent groups t-test|||||||<0.001
70888552|NCT00048724|141263357|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.452||||0.1439||95.0|0.88|2.396|||Cox Proportional Hazards Model|Age (\<= 50 years, \>50 years) and participation in a prior study (yes, no) were stratification factors.|Hazard ratio represents results of untreated control relative to treatment.|The primary scientific hypothesis is that, 0.5 ug/kg subcutaneous once weekly PegIntron as maintenance therapy is efficacious, when compared to no treatment, in the prevention of clinical events in adult subjects with compensated cirrhosis (Metavir F4), secondary to Chronic Hepatitis C, who have failed to respond to therapy with any α interferon plus ribavirin.||2.396|0.880|0.1439
70888553|NCT00048724|141263358|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.564||||0.007||95.0|1.13|2.166|||Cox Proportional Hazards Model|Age (\<= 50 years, \>50 years) and participation in a prior study (yes, no) were stratification factors.|Hazard ratio represents results of untreated control relative to treatment.|The secondary hypothesis is that 0.5 ug/kg subcutaneous once weekly PegIntron as maintenance therapy is efficacious, when compared to no treatment, in the prevention of disease progression in adult subjects with compensated cirrhosis (Metavir F4), secondary to Chronic Hepatitis C, who have failed to respond to therapy with any α interferon plus ribavirin.||2.166|1.130|0.0070
70888554|NCT02595684|141263359|SUPERIORITY|||||||0.327|||||||Wilcoxon (Mann-Whitney)|||||||0.327
70888555|NCT02595684|141263359|SUPERIORITY|||||||0.635|||||||Wilcoxon (Mann-Whitney)|||||||0.635
70888556|NCT02595684|141263360|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.380
70888557|NCT02595684|141263360|SUPERIORITY|||||||0.441|||||||Wilcoxon (Mann-Whitney)|||||||0.441
70888558|NCT02595684|141263361|SUPERIORITY|||||||515|||||||Wilcoxon (Mann-Whitney)|||||||0515
70888559|NCT02595684|141263361|SUPERIORITY|||||||0.953|||||||Wilcoxon (Mann-Whitney)|||||||0.953
70888560|NCT02595684|141263362|SUPERIORITY|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||||||0.314
70888561|NCT02595684|141263362|SUPERIORITY|||||||0.594|||||||Wilcoxon (Mann-Whitney)|||||||0.594
70888562|NCT02595684|141263363|SUPERIORITY|||||||0.767|||||||Wilcoxon (Mann-Whitney)|||||||0.767
70888563|NCT02595684|141263363|SUPERIORITY|||||||0.779|||||||Wilcoxon (Mann-Whitney)|||||||0.779
70888564|NCT02595684|141263364|SUPERIORITY|||||||0.859|||||||Wilcoxon (Mann-Whitney)|||||||0.859
70888565|NCT02595684|141263364|SUPERIORITY|||||||0.767|||||||Wilcoxon (Mann-Whitney)|||||||0.767
70888566|NCT02595684|141263365|SUPERIORITY|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||||||0.374
70888567|NCT02595684|141263365|SUPERIORITY|||||||0.953|||||||Wilcoxon (Mann-Whitney)|||||||0.953
70888568|NCT02595684|141263366|SUPERIORITY|||||||0.594|||||||Wilcoxon (Mann-Whitney)|||||||0.594
70888569|NCT02595684|141263366|SUPERIORITY|||||||0.085|||||||Wilcoxon (Mann-Whitney)|||||||0.085
70888570|NCT02595684|141263367|SUPERIORITY|||||||0.594|||||||Wilcoxon (Mann-Whitney)|||||||0.594
70888571|NCT02595684|141263367|SUPERIORITY|||||||0.086|||||||Wilcoxon (Mann-Whitney)|||||||0.086
70888572|NCT02595684|141263368|SUPERIORITY|||||||0.285|||||||Wilcoxon (Mann-Whitney)|||||||0.285
70888573|NCT02595684|141263368|SUPERIORITY|||||||0.854|||||||Wilcoxon (Mann-Whitney)|||||||0.854
70888574|NCT02595684|141263369|SUPERIORITY|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||||||0.374
70888575|NCT02595684|141263369|SUPERIORITY|||||||0.263|||||||Wilcoxon (Mann-Whitney)|||||||0.263
70888576|NCT02595684|141263370|SUPERIORITY|||||||0.859|||||||Wilcoxon (Mann-Whitney)|||||||0.859
70888577|NCT02595684|141263370|SUPERIORITY|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||||||0.374
70888578|NCT02595684|141263371|SUPERIORITY|||||||0.722|||||||Wilcoxon (Mann-Whitney)|||||||0.722
70888579|NCT02595684|141263371|SUPERIORITY|||||||0.953|||||||Wilcoxon (Mann-Whitney)|||||||0.953
70888580|NCT02595684|141263372|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.260
70888581|NCT02595684|141263372|SUPERIORITY|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||||||0.314
70888582|NCT02595684|141263373|SUPERIORITY|||||||0.058|||||||Wilcoxon (Mann-Whitney)|||||||0.058
70888583|NCT02595684|141263373|SUPERIORITY|||||||0.952|||||||Wilcoxon (Mann-Whitney)|||||||0.952
70888584|NCT02595684|141263374|SUPERIORITY|||||||0.128|||||||Wilcoxon (Mann-Whitney)|||||||0.128
70888585|NCT02595684|141263374|SUPERIORITY|||||||0.108|||||||Wilcoxon (Mann-Whitney)|||||||0.108
70888586|NCT02595684|141263375|SUPERIORITY|||||||0.092|||||||Wilcoxon (Mann-Whitney)|||||||0.092
70888587|NCT02595684|141263375|SUPERIORITY|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||||||0.374
70888588|NCT03235024|141263390|EQUIVALENCE|A sample size of 52 per group would achieve \>80% power to reject the null hypothesis of equal means when the population mean difference is μ1 - μ2 = (-1.4) - (-5.3) = 3.9 with a standard deviation for both groups of 7.0 and with a significance level (alpha) of 0.025 using a 1-sided 2-sample equal variance t-test.||||||0.0228||||||At Week 2|t-test, 1 sided|||||||0.0228
70888589|NCT01243944|141263397|SUPERIORITY_OR_OTHER||Odds Ratio, log|32.67|||<|0.0001|TWO_SIDED|95.0|5.04|1337.0|||Exact Cochran-Mantel-Haenszel|||||1337|5.04|< 0.0001
70888590|NCT01243944|141263398|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|28.01|||<|0.0001|TWO_SIDED|95.0|4.24|1144.0|||Exact Cochran-Mantel-Haenszel|||||1144|4.24|<0.0001
70888591|NCT01243944|141263399|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.57||||0.0016|TWO_SIDED|95.0|1.5|9.06|||Exact Cochran-Mantel-Haenszel|P-value was calculated using stratified exact Cochran-Mantel-Haenszel test by adjusting for the WBC/platelet status (abnormal vs normal) at baseline.||||9.06|1.50|0.0016
70888592|NCT02802345|141263419|SUPERIORITY||Adjusted mean difference|-0.52|STANDARD_ERROR_OF_MEAN|1.431||0.7191|TWO_SIDED|95.0|-3.33|2.3|||Mixed Model for Repeated Measures (MMRM)|The Roger- Kenward approximation was used to estimate denominator degrees of freedom.|Adjusted mean difference (Nintedanib +placebo vs Nintedanib+sildenafil) is based on all analyzed patients in the model (not only patients with a measurement at baseline and at 12 weeks).|Mixed Model for Repeated Measures (MMRM) included fixed effects for treatment, visit, presence of any echocardiographic signs, baseline SGRQ total score as covariate, treatment-by-visit and baseline SGRQ total score-by-visit interaction terms using an unstructured covariance matrix. No imputation was planned. Data collected after Visit 5 (planned 12 weeks after start of study treatment) were not used for this analysis.|"H0: There is no difference in the mean change from baseline in SGRQ total score at Week 12 between treatment with nintedanib co-administered with sildenafil and treatment with nintedanib alone.~Ha: There is a difference in the mean change from baseline in SGRQ total score at Week 12 between treatment with nintedanib co-administered with sildenafil and treatment with nintedanib alone."|2.30|-3.33|0.7191
70888593|NCT02802345|141263420|SUPERIORITY||Adjusted mean difference|-2.94|STANDARD_ERROR_OF_MEAN|2.198||0.1823|TWO_SIDED|95.0|-7.27|1.39|||Mixed Model for Repeated Measures (MMRM)|The Roger- Kenward approximation was used to estimate denominator degrees of freedom.|Adjusted mean difference (Nintedanib +placebo vs Nintedanib+sildenafil) is based on all analyzed patients in the model (not only patients with a measurement at baseline and at 12 weeks)|Mixed Model for Repeated Measures (MMRM) included fixed effects for treatment, visit, presence of any echocardiographic signs, baseline UCSD SOBQ total score as covariate, treatment-by-visit and baseline UCSD SOBQ total score-by-visit interaction terms using an unstructured covariance matrix. No imputation was planned. Data collected after Visit 5 (planned 12 weeks after start of study treatment) were not used for this analysis.||1.39|-7.27|0.1823
70888594|NCT02802345|141263421|SUPERIORITY||Adjusted mean difference|-2.19|STANDARD_ERROR_OF_MEAN|1.631||0.1809|TWO_SIDED|95.0|-5.4|1.02|||Mixed Model for Repeated Measures (MMRM)|The Roger- Kenward approximation was used to estimate denominator degrees of freedom.|Adjusted mean difference (Nintedanib +placebo vs Nintedanib+sildenafil) is based on all analyzed patients in the model (not only patients with a measurement at baseline and at 24 weeks)|Mixed Model for Repeated Measures (MMRM) included fixed effects for treatment, visit, presence of any echocardiographic signs, baseline SGRQ total score as covariate, treatment-by-visit and baseline SGRQ total score-by-visit interaction terms using an unstructured covariance matrix. No imputation was planned.||1.02|-5.40|0.1809
70888595|NCT02802345|141263422|SUPERIORITY||Adjusted mean difference|-2.41|STANDARD_ERROR_OF_MEAN|2.529||0.3421|TWO_SIDED|95.0|-7.39|2.58|||Mixed Model for Repeated Measures (MMRM)|The Roger- Kenward approximation was used to estimate denominator degrees of freedom.|Adjusted mean difference (Nintedanib +placebo vs Nintedanib+sildenafil) is based on all analyzed patients in the model (not only patients with a measurement at baseline and at 24 weeks)|Mixed Model for Repeated Measures (MMRM) included fixed effects for treatment, visit, presence of any echocardiographic signs, baseline UCSD SOBQ total score as covariate, treatment-by-visit and baseline UCSD SOBQ total score-by-visit interaction terms using an unstructured covariance matrix. No imputation was planned.||2.58|-7.39|0.3421
70888596|NCT02802345|141263423|SUPERIORITY||Percentage ratio (%)|0.83|||||TWO_SIDED|95.0|0.58|1.2|||||Within strata confidence limits are calculated according to Wald. Percentage ratio = (% of Nintedanib+sildenafil) / (% of Nintedanib+placebo).|Relative risk, Comparison of treatment groups is calculated by Cochran-Mantel-Haenszel test adjusting for the categorical covariate presence of any echocardiographic signs indicative of right heart dysfunction (yes/no), adjusted Mantel-Haenszel type risk ratios and risk differences with 95% confidence are presented.||1.20|0.58|
70888597|NCT02802345|141263423|SUPERIORITY||Percentage difference (%)|-5.37||||0.334|TWO_SIDED|95.0|-16.25|5.52|||Cochran-Mantel-Haenszel||Within strata confidence limits are calculated according to Wald. Percentage difference = (% of Nintedanib+sildenafil) - (% of Nintedanib+placebo).|Risk difference, Comparison of treatment groups is calculated by Cochran-Mantel-Haenszel test adjusting for the categorical covariate presence of any echocardiographic signs indicative of right heart dysfunction (yes/no), adjusted Mantel-Haenszel type risk ratios and risk differences with 95% confidence are presented.||5.52|-16.25|0.334
70888598|NCT04632940|141263424|OTHER||LS Mean Difference|-0.528|STANDARD_ERROR_OF_MEAN|0.8912||0.5553|TWO_SIDED|95.0|-2.308|1.251|||Mixed Models Analysis|||||1.251|-2.308|0.5553
70888599|NCT02799082|141263437|SUPERIORITY_OR_OTHER||||||<|0.0001||||||"The percentages stated relate to the total number of subjects for the respective week and treatment.~Cochran-Mantel-Haenszel Test stratified by center"|Cochran-Mantel-Haenszel|||||||<0.0001
70888600|NCT02799082|141263438|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70888601|NCT02799082|141263446|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70888602|NCT02799082|141263447|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70888603|NCT00727857|141263474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86|||<|0.0001||95.0|0.51|1.22|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way Analysis of Covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate. Least Squares (LS) mean change and LS mean of the treatment difference reported.||1.22|0.51|<0.0001
70888604|NCT00727857|141263474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.84|||<|0.0001||95.0|0.5|1.18|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||1.18|0.50|<0.0001
70888605|NCT00727857|141263474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.8919||95.0|-0.37|0.33|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.33|-0.37|0.8919
70888606|NCT00727857|141263475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.8||||0.0005||95.0|7.8|27.7|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||27.7|7.8|0.0005
70888607|NCT00727857|141263475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.1||||0.0021||95.0|5.5|24.7|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||24.7|5.5|0.0021
70888608|NCT00727857|141263475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.5981||95.0|-12.5|7.2|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||7.2|-12.5|0.5981
70888609|NCT00727857|141263476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73||||0.5074||95.0|-1.43|2.88|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||2.88|-1.43|0.5074
70888610|NCT00727857|141263476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.93||||0.0047||95.0|0.9|4.95|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||4.95|0.90|0.0047
70888611|NCT00727857|141263476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2||||0.0435||95.0|0.06|4.33|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||4.33|0.06|0.0435
70888612|NCT00727857|141263477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.629||||0.3158||95.0|-0.602|1.861|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||1.861|-0.602|0.3158
70888613|NCT00727857|141263477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.619||||0.0067||95.0|0.452|2.785|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||2.785|0.452|0.0067
70888614|NCT00727857|141263477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.989||||0.1094||95.0|-0.223|2.201|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||2.201|-0.223|0.1094
70888615|NCT00727857|141263478|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.88||||0.5963||95.0|-4.71|13.97|||ANCOVA||The estimate of the median percent change from baseline and 95% confidence intervals were based on the Hodges-Lehmann method and the distribution-free confidence interval.|Nonparametric ANCOVA based on Tukey's normal rank transformation with a term for treatment and the baseline value as a covariate.||13.97|-4.71|0.5963
70888616|NCT00727857|141263478|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|12.81||||0.0265||95.0|2.88|22.24|||ANCOVA||The estimate of the median percent change from baseline and 95% confidence intervals were based on the Hodges-Lehmann method and the distribution-free confidence interval.|Nonparametric ANCOVA based on Tukey's normal rank transformation with a term for treatment and the baseline value as a covariate.||22.24|2.88|0.0265
70888617|NCT00727857|141263478|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|8.33||||0.1053||95.0|-1.77|18.07|||ANCOVA||The estimate of the median percent change from baseline and 95% confidence intervals were based on the Hodges-Lehmann method and the distribution-free confidence interval.|Nonparametric ANCOVA based on Tukey's normal rank transformation with a term for treatment and the baseline value as a covariate.||18.07|-1.77|0.1053
70888618|NCT00727857|141263479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.0806||95.0|-0.2|3.1|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||3.1|-0.2|0.0806
70888619|NCT00727857|141263479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1|||<|0.0001||95.0|-9.6|-6.5|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-6.5|-9.6|<0.0001
70888620|NCT00727857|141263479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.5|||<|0.0001||95.0|-11.1|-7.9|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-7.9|-11.1|<0.0001
70888621|NCT00727857|141263480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.73||||0.0324||95.0|0.31|7.14|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||7.14|0.31|0.0324
70888622|NCT00727857|141263480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.78||||0.0233||95.0|-7.05|-0.52|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.52|-7.05|0.0233
70888623|NCT00727857|141263480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.51|||<|0.0001||95.0|-10.9|-4.12|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-4.12|-10.90|<0.0001
70888624|NCT00727857|141263481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9||||0.0993||95.0|-0.93|10.72|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||10.72|-0.93|0.0993
70888625|NCT00727857|141263481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.56||||0.367||95.0|-8.14|3.01|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||3.01|-8.14|0.3670
70888626|NCT00727857|141263481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.46||||0.0119||95.0|-13.26|-1.66|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-1.66|-13.26|0.0119
70888627|NCT00727857|141263482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.31||||0.0423||95.0|-8.48|-0.15|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.15|-8.48|0.0423
70888628|NCT00727857|141263482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1|||<|0.0001||95.0|-12.08|-4.12|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-4.12|-12.08|<0.0001
70888629|NCT00727857|141263482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.79||||0.728||95.0|-7.93|0.35|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.35|-7.93|0.728
70888630|NCT00727857|141263483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.9231||95.0|-7.94|8.76|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||8.76|-7.94|0.9231
70888631|NCT00727857|141263483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.16||||0.3082||95.0|-3.86|12.19|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||12.19|-3.86|0.3082
70888632|NCT00727857|141263483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75||||0.3753||95.0|-4.56|12.07|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||12.07|-4.56|0.3753
70888633|NCT00727857|141263484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.4||||0.4999||95.0|-44.6|91.4|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with a term for treatment and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||91.4|-44.6|0.4999
70888634|NCT00727857|141263484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|64.2||||0.0531||95.0|-0.9|129.3|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with a term for treatment and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||129.3|-0.9|0.0531
70888635|NCT00727857|141263484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.9||||0.2369||95.0|-26.9|108.7|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with a term for treatment and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||108.7|-26.9|0.2369
70888636|NCT00727857|141263485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.5023||95.0|-0.09|0.19|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.19|-0.09|0.5023
70888637|NCT00727857|141263485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.0001||95.0|-0.48|-0.21|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.21|-0.48|<0.0001
70888638|NCT00727857|141263485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||<|0.0001||95.0|-0.53|-0.25|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.25|-0.53|<0.0001
70888639|NCT00727857|141263486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.7||||0.2849||95.0|-16.5|55.9|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||55.9|-16.5|0.2849
70888640|NCT00727857|141263486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-77.6|||<|0.0001||95.0|-112.4|-42.8|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-42.8|-112.4|<0.0001
70888641|NCT00727857|141263486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-97.3|||<|0.0001||95.0|-133.4|-61.2|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-61.2|-133.4|<0.0001
70888642|NCT00727857|141263487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3||||0.2894||95.0|-4.5|15.1|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||15.1|-4.5|0.2894
70888643|NCT00727857|141263487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.8463||95.0|-10.3|8.5|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||8.5|-10.3|0.8463
70888644|NCT00727857|141263487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.2||||0.2124||95.0|-16.0|3.6|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||3.6|-16.0|0.2124
70888645|NCT00727857|141263488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.804||95.0|-19.4|15.0|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||15.0|-19.4|0.8040
70888646|NCT00727857|141263488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.5||||0.0008||95.0|12.0|45.0|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||45.0|12.0|0.0008
70888647|NCT00727857|141263488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.6||||0.0005||95.0|13.4|47.8|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||47.8|13.4|0.0005
70888648|NCT00727857|141263489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.9604||95.0|-83.3|79.2|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||79.2|-83.3|0.9604
70888649|NCT00727857|141263489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|140.3||||0.0004||95.0|62.5|218.0|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||218.0|62.5|0.0004
70888650|NCT00727857|141263489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|142.3||||0.0006||95.0|61.3|223.3|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||223.3|61.3|0.0006
70888651|NCT00727857|141263490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.9922||95.0|-64.4|65.1|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||65.1|-64.4|0.9922
70888652|NCT00727857|141263490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|111.7||||0.0004||95.0|49.7|173.7|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||173.7|49.7|0.0004
70888653|NCT00727857|141263490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|111.4||||0.0008||95.0|46.8|175.9|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||175.9|46.8|0.0008
70888654|NCT00727857|141263491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.0072||95.0|-1.86|-0.29|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.29|-1.86|0.0072
70888655|NCT00727857|141263491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.3682||95.0|-0.41|1.1|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||1.10|-0.41|0.3682
70888656|NCT00727857|141263491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.42||||0.0004||95.0|0.64|2.2|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||2.20|0.64|0.0004
70888657|NCT00727857|141263492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.1986||95.0|-0.02|0.1|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.10|-0.02|0.1986
70888658|NCT00727857|141263492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.1487||95.0|-0.1|0.02|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.02|-0.10|0.1487
70888659|NCT00727857|141263492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.0076||95.0|-0.14|-0.02|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.02|-0.14|0.0076
70888660|NCT00727857|141263493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.2384||95.0|-0.21|0.83|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.83|-0.21|0.2384
70888661|NCT00727857|141263493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.4617||95.0|-0.69|0.31|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.31|-0.69|0.4617
70888662|NCT00727857|141263493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0593||95.0|-1.02|0.02|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.02|-1.02|0.0593
70888663|NCT00727857|141263494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.5044||95.0|-0.54|1.1|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||1.10|-0.54|0.5044
70888664|NCT00727857|141263494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.43||||0.0004||95.0|-2.22|-0.64|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.64|-2.22|0.0004
70888665|NCT00727857|141263494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71|||<|0.0001||95.0|-2.53|-0.89|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.89|-2.53|<0.0001
70888666|NCT00727857|141263495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63||||0.0017||95.0|-2.64|-0.62|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.62|-2.64|0.0017
70888667|NCT00727857|141263495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.97|||<|0.0001||95.0|1.01|2.94|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||2.94|1.01|<0.0001
70888668|NCT00727857|141263495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6|||<|0.0001||95.0|2.59|4.61|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||4.61|2.59|<0.0001
70888669|NCT00727857|141263496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.76||||0.2466||95.0|-2.61|10.14|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||10.14|-2.61|0.2466
70888670|NCT00727857|141263496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.52||||0.0063||95.0|-14.63|-2.42|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-2.42|-14.63|0.0063
70888671|NCT00727857|141263496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.29||||0.0002||95.0|-18.65|-5.93|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-5.93|-18.65|0.0002
70888672|NCT00727857|141263497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15||||0.2069||95.0|-2.93|0.64|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.64|-2.93|0.2069
70888673|NCT00727857|141263497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.44||||0.0052||95.0|0.73|4.15|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||4.15|0.73|0.0052
70888674|NCT00727857|141263497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.59|||<|0.0001||95.0|1.81|5.36|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||5.36|1.81|<0.0001
70888675|NCT00727857|141263498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.609||95.0|-1.28|0.75|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.75|-1.28|0.6090
70888676|NCT00727857|141263498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.6169||95.0|-1.22|0.72|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.72|-1.22|0.6169
70888677|NCT00727857|141263498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.974||95.0|-0.99|1.03|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||1.03|-0.99|0.9740
70888678|NCT00727857|141263499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06||||0.615||95.0|-3.09|5.21|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||5.21|-3.09|0.6150
70888679|NCT00727857|141263499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.41||||0.2346||95.0|-6.38|1.57|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||1.57|-6.38|0.2346
70888680|NCT00727857|141263499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47||||0.1001||95.0|-7.61|0.67|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.67|-7.61|0.1001
70888681|NCT00727857|141263500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.86||||0.1217||95.0|-0.76|6.48|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||6.48|-0.76|0.1217
70888682|NCT00727857|141263500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9||||0.0009||95.0|-9.36|-2.44|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-2.44|-9.36|0.0009
70888683|NCT00727857|141263500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.76|||<|0.0001||95.0|-12.36|-5.16|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-5.16|-12.36|<0.0001
70888684|NCT02617589|141263552|SUPERIORITY|Hazard Ratio is Nivolumab over Temozolomide|Stratified Cox proportional hazard model|1.31||||0.0037|TWO_SIDED|95.0|1.09|1.58|||Log-rank test stratified|Log-rank test stratified by complete or partial resection at baseline as entered into the IVRS.||||1.58|1.09|0.0037
70888685|NCT02617589|141263553|SUPERIORITY|Hazard Ratio is Nivolumab over Temozolomide|Stratified Cox proportional hazard model|1.43|||||TWO_SIDED|95.0|1.19|1.71|||Log-rank test stratified|Log-rank test stratified by complete or partial resection at baseline as entered into the IVRS.||||1.71|1.19|
70888686|NCT02617589|141263557|SUPERIORITY|Hazard Ratio is Nivolumab over Temozolomide|Stratified Cox proportional hazard model|1.31||||0.0024|TWO_SIDED|95.0|1.1|1.55|||Log-rank test stratified|Log-rank test stratified by complete or partial resection at baseline as entered into the IVRS.||||1.55|1.10|0.0024
70888687|NCT00835406|141263565|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA will be performed on ln-transformed Ae0-36 and Rmax at the α level of 0.05.|Ratio of the mean|97.94||||||90.0|90.96|105.45|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.45|90.96|
70888688|NCT00835406|141263566|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA will be performed on ln-transformed Ae0-35 and Rmax at the α level of 0.05.|Ratio of the mean|100.36||||||90.0|92.85|108.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||108.48|92.85|
70888689|NCT02138214|141263609|OTHER|||||||0.567||||||p-value threshold for statistical significance is 0.05|Fisher Exact|||||||0.567
70888690|NCT02138214|141263610|OTHER|||||||0.11|||||||t-test, 2 sided|||||||0.110
70888691|NCT02138214|141263612|OTHER|||||||0.758|||||||Fisher Exact|||||||0.758
70888692|NCT02138214|141263614|OTHER|||||||0.236|||||||Fisher Exact|||||||0.236
70888693|NCT02138214|141263615|OTHER|||||||0.759|||||||t-test, 2 sided|||||||0.759
70888694|NCT02138214|141263616|OTHER|||||||0.4|||||||t-test, 2 sided|||||||0.400
70888695|NCT01196871|141263629|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUC0-t Ratio|2.942|||||TWO_SIDED|90.0|2.439|3.548|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 AUC0-t Data: Point estimates for the geometric means and their 90% confidence interval (CI) are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||3.548|2.439|
70888696|NCT01196871|141263629|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUCinfinity Ratio|2.942|||||TWO_SIDED|90.0|2.431|3.56|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 AUCinfinity Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||3.560|2.431|
70888697|NCT01196871|141263629|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUC0-t Ratio|2.354|||||TWO_SIDED|90.0|1.826|3.035|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 2 AUC0-t Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||3.035|1.826|
70888698|NCT01196871|141263629|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUCinfinity Ratio|2.375|||||TWO_SIDED|90.0|1.839|3.068|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 2 AUCinfinity Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||3.068|1.839|
70888699|NCT01196871|141263630|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|Cmax Ratio|1.629|||||TWO_SIDED|90.0|1.44|1.843|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 Cmax Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.843|1.440|
70888700|NCT01196871|141263630|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|Cmax Ratio|1.546|||||TWO_SIDED|90.0|1.3|1.838|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 2 Cmax Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.838|1.300|
70888701|NCT01196871|141263632|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUC0-t Ratio|1.025|||||TWO_SIDED|90.0|0.921|1.14|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 AUC0-t Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.140|0.921|
70888702|NCT01196871|141263632|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects mode Log (parameter) = Intercept + ß\*Treatment + Error.|AUC0-t Ratio|1.256|||||TWO_SIDED|90.0|1.026|1.538|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 2 AUC0-t Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.538|1.026|
70888703|NCT01196871|141263634|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|Cmax Ratio|1.034|||||TWO_SIDED|90.0|0.929|1.152|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 Cmax Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.152|0.929|
70888704|NCT01196871|141263634|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|Cmax Ratio|1.063|||||TWO_SIDED|90.0|0.972|1.164|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 2 Cmax Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.164|0.972|
70888705|NCT01196871|141263636|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUC0-t Ratio|1.059|||||TWO_SIDED|90.0|0.818|1.371|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 AUC0-t Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.371|0.818|
70888706|NCT01196871|141263636|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUCinfinity Ratio|1.052|||||TWO_SIDED|90.0|0.807|1.371|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 AUCinfinity Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.371|0.807|
70888707|NCT01196871|141263637|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|Cmax Ratio|0.997|||||TWO_SIDED|90.0|0.791|1.259|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 Cmax Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.259|0.791|
70888708|NCT03509948|141263646|SUPERIORITY||Geometric Least Squares Mean|79.57|||||TWO_SIDED|90.0|66.4|95.35||||||Fed/Fasted Ratio||95.35|66.40|
70888709|NCT03509948|141263647|SUPERIORITY||Geometric Least Squares Mean|92.08|||||TWO_SIDED|90.0|88.37|95.95||||||Fed/Fasted Ratio||95.95|88.37|
70888710|NCT03509948|141263648|SUPERIORITY||Geometric Least Squares Mean|90.89|||||TWO_SIDED|90.0|84.99|97.2||||||Fed/Fasted Ratio||97.20|84.99|
70888711|NCT03509948|141263650|SUPERIORITY||Geometric Least Squares Mean|1.0|||||TWO_SIDED|90.0|0.25|1.75||||||Fed/Fasted Ratio||1.75|0.25|
70888712|NCT03509948|141263652|SUPERIORITY||Geometric Least Squares Mean|91.4|||||TWO_SIDED|90.0|87.55|95.41||||||Fed/Fasted Ratio||95.41|87.55|
70888713|NCT01071512|141263664|OTHER|||||||0.17|||||||Mixed Models Analysis|||Analysis used all available data from subjects, including those who dropped out early.||||0.17
70888714|NCT01071512|141263665|OTHER|||||||0.6|||||||Mixed Models Analysis|||Analysis used all available data||||0.6
70888715|NCT01071512|141263666|OTHER|||||||0.3|||||||Mixed Models Analysis|||Analysis used all available data||||0.3
70888716|NCT01071512|141263667|OTHER|||||||0.02|||||||Mixed Models Analysis|||Analysis used all available data||||0.02
70888717|NCT01071512|141263668|OTHER|||||||0.9|||||||Mixed Models Analysis|||Analysis used all available data||||0.9
70888718|NCT02076412|141263681|SUPERIORITY||Risk Difference (RD)|13.8||||0.1519|TWO_SIDED|95.0|0.5|27.1|||Fisher Exact||Confidence interval for treatment difference (risk difference) was based on the normal approximation|||27.1|0.5|0.1519
70888719|NCT02076412|141263686|SUPERIORITY||Risk Difference (RD)|-0.01||||0.4927|TWO_SIDED|95.0|-0.05|0.02||P-value from a two-sided two-sample t-test, testing for a difference in means between fostamatinib and placebo.|t-test, 2 sided|||||0.02|-0.05|0.4927
70888720|NCT02076412|141263687|SUPERIORITY||Risk Difference (RD)|-0.12||||0.2499|TWO_SIDED|95.0|-0.32|0.09||P-value from a two-sided two-sample t-test, testing for a difference in means between fostamatinib and placebo.|t-test, 2 sided|||||0.09|-0.32|0.2499
70888721|NCT00799617|141263697|SUPERIORITY||Mean Difference (Net)|0.58|||<|0.001|TWO_SIDED|95.0|0.38|0.78||The p value for the treatment effect was determined with the use of a linear mixed model with a random effect for participant.|Mixed Models Analysis|Adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, use of PDE5 inhibitors||||0.78|0.38|<0.001
70888722|NCT00799617|141263698|SUPERIORITY||Odds Ratio (OR)|1.42||||0.2|TWO_SIDED|95.0|0.83|2.45||The P value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||The treatment effect for dichotomous outcomes is the odds ratio for achieving the outcome versus not achieving the outcome among men assigned to testosterone versus those assigned to placebo.||2.45|0.83|0.20
70888723|NCT00799617|141263699|SUPERIORITY||Odds Ratio (OR)|1.23||||0.3|TWO_SIDED|95.0|0.83|1.84||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||1.84|0.83|0.30
70888724|NCT00799617|141263700|SUPERIORITY||Mean Difference (Final Values)|41.0||||0.003|TWO_SIDED|95.0|14.0|67.0||Determined by a linear mixed model with all balancing factors and baseline outcome value as covariates and a random effect for participant.|Regression, Linear||Mean difference in change from baseline for participants assigned to testosterone v. placebo, with adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, PDE5 inhibitors, baseline outcome.|||67|14|.003
70888725|NCT00799617|141263701|SUPERIORITY||Mean Difference (Final Values)|6.8|||<|0.001|TWO_SIDED|95.0|4.8|8.7||Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors.|Regression, Linear|||||8.7|4.8|<.001
70888726|NCT00799617|141263702|SUPERIORITY||Mean Difference (Net)|-0.07||||0.88|TWO_SIDED|95.0|-0.92|0.79||The estimated difference and P-value were determined by a linear mixed-model with a random effect for participants using outcomes at month 6 and month 12.|Mixed Models Analysis|||"A positive estimated difference indicates greater increases, smaller decreases, or both for the testosterone group compared with the placebo group.~The difference is the mean difference in the change from baseline to 6 months to 12 months in participants allocated to testosterone vs placebo adjusted for balancing factors."||0.79|-0.92|.88
70888727|NCT00799617|141263703|SUPERIORITY|Dichotomous hemoglobin response is an increase of 1g/dL or more from baseline.|Odds Ratio (OR)|31.5||||0.002|TWO_SIDED|95.0|3.7|277.8||The P-value for the significance of the treatment effect was determined by a logistic mixed model with a random intercept for participant.|Mixed Models Analysis|The statistical analysis was intent-to-treat by a logistic mixed effects model adjusted for balancing factors.||||277.8|3.7|.002
70888728|NCT00799617|141263704|SUPERIORITY||Mean Difference (Net)|2.93|||<|0.001|TWO_SIDED|95.0|2.13|3.74||The p value for the treatment effect was determined with the use of a linear mixed model with a random effect for participant.|Mixed Models Analysis|Adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, use of PDE5 inhibitors||||3.74|2.13|<0.001
70888729|NCT00799617|141263705|SUPERIORITY||Median Difference (Net)|2.64|||<|0.001|TWO_SIDED|95.0|1.68|3.61||The p value for the treatment effect was determined with the use of a linear mixed model with a random effect for participant.|Mixed Models Analysis|Adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, use of PDE5 inhibitors||||3.61|1.68|<0.001
70888730|NCT00799617|141263706|SUPERIORITY||Mean Difference (Final Values)|4.09||||0.28|TWO_SIDED|95.0|-3.0|11.18||The P value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||11.18|-3.00|0.28
70888731|NCT00799617|141263707|SUPERIORITY||Odds Ratio (OR)|1.34||||0.15|TWO_SIDED|95.0|0.9|2.0||The P value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||2.00|0.90|0.15
70888732|NCT00799617|141263708|SUPERIORITY||Mean Difference (Net)|2.75||||0.03|TWO_SIDED|95.0|0.2|5.29||The P value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||5.29|0.20|0.03
70888733|NCT00799617|141263709|SUPERIORITY||Mean Difference (Net)|1.21||||0.06|TWO_SIDED|95.0|-0.04|2.46||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||2.46|-0.04|0.06
70888734|NCT00799617|141263710|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.41||||0.03|TWO_SIDED|95.0|0.31|4.5||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||4.50|0.31|0.03
70888735|NCT00799617|141263711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.47||||0.04|TWO_SIDED|95.0|0.02|0.92||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||0.92|0.02|0.04
70888736|NCT00799617|141263712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49|||<|0.001|TWO_SIDED|95.0|-0.79|-0.19||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Treatment Effect|||||-0.19|-0.79|<0.001
70888737|NCT00799617|141263713|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.72||||0.004|TWO_SIDED|95.0|-1.2|-0.23||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Treatment Effect|||||-0.23|-1.20|0.004
70888738|NCT00799617|141263714|SUPERIORITY||Mean Difference (Final Values)|47.0||||0.006|TWO_SIDED|95.0|13.0|80.0||Determined by linear mixed model with all balancing factors and baseline outcome value as covariates and a random effect for participant.|Regression, Linear||Mean difference in change from baseline for participants assigned to testosterone v. placebo, with adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, PDE5 inhibitors, baseline outcome.|||80|13|.006
70888739|NCT00799617|141263715|SUPERIORITY||Mean Difference (Final Values)|-27.0||||0.31|TWO_SIDED|95.0|-80.0|26.0||Determined by a linear mixed model with all balancing factors and baseline outcome value as covariates and a random effect for participant.|Regression, Linear||Mean difference in change from baseline for participants assigned to testosterone v. placebo, with adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, PDE5 inhibitors, baseline outcome.|||26|-80|.31
70888740|NCT00799617|141263716|SUPERIORITY||Mean Difference (Final Values)|2.9|||<|0.001|TWO_SIDED|95.0|2.1|3.7||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||3.7|2.1|<.001
70888741|NCT00799617|141263717|SUPERIORITY||Mean Difference (Final Values)|4.2|||<|0.001|TWO_SIDED|95.0|3.2|5.3||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||5.3|3.2|<.001
70888742|NCT00799617|141263718|SUPERIORITY||Median Difference (Final Values)|1.5|||<|0.001|TWO_SIDED|95.0|0.9|2.0||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||2.0|0.9|<.001
70888743|NCT00799617|141263719|SUPERIORITY||Mean Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|95.0|0.5|1.5||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||1.5|0.5|<.001
70888744|NCT00799617|141263720|SUPERIORITY||Mean Difference (Final Values)|1.3|||<|0.001|TWO_SIDED|95.0|0.8|1.7|||Regression, Linear|||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."||1.7|0.8|<.001
70888745|NCT00799617|141263721|SUPERIORITY||Mean Difference (Final Values)|7.1|||<|0.001|TWO_SIDED|95.0|5.3|809.0||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||809|5.3|<.001
70888746|NCT00799617|141263722|SUPERIORITY||Mean Difference (Final Values)|8.5|||<|0.001|TWO_SIDED|95.0|6.0|10.9||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||10.9|6.0|<.001
70888747|NCT00799617|141263723|SUPERIORITY||Mean Difference (Final Values)|5.7|||<|0.001|TWO_SIDED|95.0|4.3|7.2||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||7.2|4.3|<.001
70888748|NCT00799617|141263724|SUPERIORITY||Mean Difference (Final Values)|1.8|||<|0.001|TWO_SIDED|95.0|1.1|2.6||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||2.6|1.1|<.001
70888749|NCT00799617|141263725|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.005|TWO_SIDED|95.0|0.3|1.7||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||1.7|0.3|.005
70888750|NCT00799617|141263726|SUPERIORITY||Mean Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|95.0|0.5|1.4||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||1.4|0.5|<.001
70888751|NCT00799617|141263727|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.01|TWO_SIDED|95.0|0.25|2.09||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||2.09|0.25|.01
70888752|NCT00799617|141263728|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.052|TWO_SIDED|95.0|-0.01|1.36||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||1.36|-0.01|.052
70888753|NCT00799617|141263729|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.27|TWO_SIDED|95.0|-0.45|1.58||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||1.58|-0.45|0.27
70888754|NCT00799617|141263730|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.24|TWO_SIDED|95.0|-0.76|0.19||The estimated difference and P-value were determined by a linear mixed-model with a random effect for participants using outcomes at month 6 and month 12.|Mixed Models Analysis||The difference is the mean difference in the change from baseline to 6 months to 12 months in participants allocated to testosterone vs placebo adjusted for balancing factors.|A positive estimated difference indicates greater increases, smaller decreases, or both for the testosterone group compared with the placebo group.||0.19|-0.76|.24
70888755|NCT00799617|141263731|SUPERIORITY||Mean Difference (Net)|-0.12||||0.89|TWO_SIDED|95.0|-1.89|1.65||The estimated difference and P-value were determined by a linear mixed-model with a random effect for participants using outcomes at month 6 and month 12.|Mixed Models Analysis||The difference is the mean difference in the change from baseline to 6 months to 12 months in participants allocated to testosterone vs placebo adjusted for balancing factors.|A positive estimated difference indicates greater increases, smaller decreases, or both for the testosterone group compared with the placebo group.||1.65|-1.89|.89
70888756|NCT00799617|141263732|SUPERIORITY||Mean Difference (Net)|-5.51||||0.14|TWO_SIDED|95.0|-12.91|1.88||The estimated difference and P-value were determined by a linear mixed-model with a random effect for participants using outcomes at month 6 and month 12.|Mixed Models Analysis||The difference is the mean difference in the change from baseline to 6 months to 12 months in participants allocated to testosterone vs placebo adjusted for balancing factors.|A positive estimated difference indicates greater increases, smaller decreases, or both for the testosterone group compared with the placebo group.||1.88|-12.91|.14
70888757|NCT00799617|141263733|SUPERIORITY||Mean Difference (Net)|0.83|||<|0.001|TWO_SIDED|95.0|0.48|1.39||The P-value for the significance of the treatment effect was determined by a linear mixed model for continuous outcomes with a random intercept for participant.|Mixed Models Analysis||Intent-to-treat analysis by a linear mixed effects model adjusted for balancing factors.|||1.39|0.48|<.001
70888758|NCT00958880|141263737|SUPERIORITY_OR_OTHER||Slope|10.46||||0.015||95.0|||||Regression, Linear|||||||.015
70888759|NCT00958880|141263738|SUPERIORITY_OR_OTHER||Slope|0.03||||0.575||95.0|||||Regression, Linear|||||||.575
70888760|NCT01848990|141263739|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the 95% CI for the treatment difference ≤0.40, it is concluded that Hylenex recombinant preadministration is noninferior to standard CSII.|least squares mean treatment difference|0.05||||0.4516|TWO_SIDED|95.0|-0.08|0.18|||ANOVA|Analysis of variance (ANOVA) with treatment (Hylenex, standard rapid-acting insulin CSII) as a fixed effect|Hylenex minus Standard CSII|Sample size calculated based on approximately 400 participants (Pt) being enrolled. No more than 10% dropout rate at 6 months allowed at least 270 Hylenex and 90 standard CSII Pt to reach primary metabolic endpoint evaluation. Assuming HbA1c standard deviation of 0.7% and population difference of 0% between treatments, Pt reaching primary efficacy endpoint would provide \>90% power to demonstrate HbA1c noninferiority at margin of 0.4% using confidence bound from 2-tailed 95% confidence interval.||0.18|-0.08|0.4516
70888761|NCT01848990|141263740|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the 95% CI for the treatment difference ≤0.40, it is concluded that Hylenex recombinant preadministration is noninferior to standard CSII.|least squares mean treatment difference|0.14||||0.0711|TWO_SIDED|95.0|-0.01|0.28|||ANOVA|ANOVA with treatment (Hylenex, standard rapid-acting insulin CSII) as a fixed effect|Hylenex minus Standard CSII|Sample size calculated based on approximately 400 Pt being enrolled. No more than 10% dropout rate at 6 months allowed at least 270 Hylenex and 90 standard CSII Pt to reach primary metabolic endpoint evaluation. Assuming HbA1c standard deviation of 0.7% and population difference of 0% between treatments, Pt reaching primary efficacy endpoint would provide \>90% power to demonstrate HbA1c noninferiority at margin of 0.4% using confidence bound from 2-tailed 95% confidence interval.||0.28|-0.01|0.0711
70888762|NCT01848990|141263741|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.69||||0.0105|TWO_SIDED|||||SMBG \<56 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.0105
70888763|NCT01848990|141263741|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.79||||0.013|TWO_SIDED|||||SMBG \<=70 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.0130
70888764|NCT01848990|141263741|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.78||||0.0511|TWO_SIDED|||||Nocturnal HEs|negative binomial model||Hylenex/Standard CSII|||||0.0511
70888765|NCT01848990|141263741|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.34||||0.1176|TWO_SIDED|||||Severe HEs|negative binomial model||Hylenex/Standard CSII|||||0.1176
70888766|NCT01848990|141263742|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.81||||0.0456|TWO_SIDED|||||SMBG \<56 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.0456
70888767|NCT01848990|141263742|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.92||||0.2322|TWO_SIDED|||||SMBG \<=70 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.2322
70888768|NCT01848990|141263742|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.87||||0.1365|TWO_SIDED|||||Nocturnal HEs|negative binomial model||Hylenex/Standard CSII|||||0.1365
70888769|NCT01848990|141263742|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|1.07||||0.8909|TWO_SIDED|||||Severe HEs|negative binomial model||Hylenex/Standard CSII|||||0.8909
70888770|NCT01848990|141263743|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.98||||0.7292|TWO_SIDED|||||SMBG \>240 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.7292
70888771|NCT01848990|141263743|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.95||||0.5895|TWO_SIDED|||||SMBG \>300 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.5895
70888772|NCT01848990|141263744|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|1.04||||0.5414|TWO_SIDED|||||SMBG \>240 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.5414
70888773|NCT01848990|141263744|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|1.03||||0.711|TWO_SIDED|||||SMBG \>300 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.7110
70888774|NCT01848990|141263745|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-3.4||||0.5394|TWO_SIDED|95.0|-14.2|7.5||Breakfast|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||7.5|-14.2|0.5394
70888775|NCT01848990|141263745|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|4.3||||0.4151|TWO_SIDED|95.0|-6.1|14.8||Lunch|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||14.8|-6.1|0.4151
70888776|NCT01848990|141263745|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.993|TWO_SIDED|95.0|-9.5|9.6||Dinner|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||9.6|-9.5|0.9930
70888777|NCT01848990|141263745|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.2||||0.941|TWO_SIDED|95.0|-6.4|6.9||Overall|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||6.9|-6.4|0.9410
70888778|NCT01848990|141263746|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-4.8||||0.3239|TWO_SIDED|95.0|-14.3|4.7||Breakfast|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||4.7|-14.3|0.3239
70888779|NCT01848990|141263746|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|1.4||||0.754|TWO_SIDED|95.0|-7.4|10.2||Lunch|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||10.2|-7.4|0.7540
70888780|NCT01848990|141263746|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-1.1||||0.7904|TWO_SIDED|95.0|-9.5|7.2||Dinner|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||7.2|-9.5|0.7904
70888781|NCT01848990|141263746|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-2.6||||0.4016|TWO_SIDED|95.0|-8.5|3.4||Overall|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||3.4|-8.5|0.4016
70888782|NCT01848990|141263747|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-1.4||||0.526|TWO_SIDED|95.0|-5.6|2.9|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||2.9|-5.6|0.5260
70888783|NCT01848990|141263748|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.5||||0.8049|TWO_SIDED|95.0|-3.7|4.7|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||4.7|-3.7|0.8049
70888784|NCT01848990|141263749|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%||||||0.8955||||||HbA1c \<7.0%|Chi-squared|||||||0.8955
70888785|NCT01848990|141263749|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%||||||0.8926||||||HbA1c ≤6.5%|Chi-squared|||||||0.8926
70888786|NCT01848990|141263750|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.13||||0.7735|TWO_SIDED|95.0|-0.76|1.03|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||1.03|-0.76|0.7735
70888787|NCT01848990|141263751|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-1.1||||0.4948|TWO_SIDED|95.0|-4.1|2.0||Daily bolus dose|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||2.0|-4.1|0.4948
70888788|NCT01848990|141263751|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|2.3||||0.1099|TWO_SIDED|95.0|-0.5|5.2||Daily basal dose|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||5.2|-0.5|0.1099
70888789|NCT01848990|141263751|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|1.4||||0.583|TWO_SIDED|95.0|-3.7|6.6||Daily total dose|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||6.6|-3.7|0.5830
70888790|NCT01848990|141263752|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.8778|TWO_SIDED|95.0|-1.0|1.1|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||1.1|-1.0|0.8778
70888791|NCT01848990|141263753|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-2.1||||0.3233|TWO_SIDED|95.0|-6.3|2.1|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||2.1|-6.3|0.3233
70888792|NCT01848990|141263755|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|1.0||||0.7708|TWO_SIDED|95.0|-5.8|7.8||Average glucose|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||7.8|-5.8|0.7708
70888793|NCT01848990|141263755|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|1.8||||0.6058|TWO_SIDED|95.0|-5.0|8.6||Median glucose|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||8.6|-5.0|0.6058
70888794|NCT01848990|141263755|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.7||||0.6571|TWO_SIDED|95.0|-4.0|2.5||Average daily standard deviation|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||2.5|-4.0|0.6571
70888795|NCT01848990|141263756|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-2.2||||0.6252|TWO_SIDED|95.0|-11.3|6.9||Time per day \<56 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||6.9|-11.3|0.6252
70888796|NCT01848990|141263756|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-5.5||||0.5929|TWO_SIDED|95.0|-25.9|14.9||Time per day ≤70 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||14.9|-25.9|0.5929
70888797|NCT01848990|141263756|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|6.9||||0.5207|TWO_SIDED|95.0|-14.4|28.3||Time per day \>70 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||28.3|-14.4|0.5207
70888798|NCT01848990|141263756|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-23.3||||0.4754|TWO_SIDED|95.0|-87.8|41.2||Time per day \<140 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||41.2|-87.8|0.4754
70888799|NCT01848990|141263756|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|23.9||||0.4644|TWO_SIDED|95.0|-40.7|88.6||Time per day ≥140 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||88.6|-40.7|0.4644
70888800|NCT01848990|141263756|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|2.8||||0.9232|TWO_SIDED|95.0|-54.2|59.8||Time per day outside of 71 to 180 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||59.8|-54.2|0.9232
70888801|NCT01848990|141263756|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|18.4||||0.5151|TWO_SIDED|95.0|-37.5|74.4||Time per day outside of 71 to 139 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||74.4|-37.5|0.5151
70888802|NCT01848990|141263757|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-33.5||||0.4216|TWO_SIDED|95.0|-115.9|48.9||Area per day \<56 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||48.9|-115.9|0.4216
70888803|NCT01848990|141263757|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-84.7||||0.5697|TWO_SIDED|95.0|-379.2|209.8||Area per day ≤70 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||209.8|-379.2|0.5697
70888804|NCT01848990|141263757|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|342.9||||0.9241|TWO_SIDED|95.0|-6772.3|7458.2||Area per day ≥140 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||7458.2|-6772.3|0.9241
70888805|NCT01848990|141263757|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|2.8||||0.9232|TWO_SIDED|95.0|-54.2|59.8||Area per day outside of 71 to 180 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||59.8|-54.2|0.9232
70888806|NCT01848990|141263757|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|Mean Difference (Final Values)|258.2||||0.9423|TWO_SIDED|95.0|-6792.2|7308.7||Area per day outside of 71 to 139 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Least squares mean treatment difference (Hylenex minus Standard CSII)|||7308.7|-6792.2|0.9423
70888807|NCT01848990|141263758|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.2||||0.5246|TWO_SIDED|95.0|-0.7|0.4||Leisure activities|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.4|-0.7|0.5246
70888808|NCT01848990|141263758|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.1||||0.638|TWO_SIDED|95.0|-0.8|0.5||Work life|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.5|-0.8|0.6380
70888809|NCT01848990|141263758|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.2||||0.5719|TWO_SIDED|95.0|-0.7|0.4||Local or long distance travel|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.4|-0.7|0.5719
70888810|NCT01848990|141263758|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.2||||0.4052|TWO_SIDED|95.0|-0.8|0.3||Vacations|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.3|-0.8|0.4052
70888811|NCT01848990|141263758|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.724|TWO_SIDED|95.0|-0.4|0.6||Do physically|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.4|0.7240
70888812|NCT01848990|141263758|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.6876|TWO_SIDED|95.0|-0.4|0.6||Family life|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.4|0.6876
70888813|NCT01848990|141263758|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.6478|TWO_SIDED|95.0|-0.4|0.6||Friendships and social life|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.4|0.6478
70888814|NCT01848990|141263758|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.9744|TWO_SIDED|95.0|-0.6|0.6||Close personal relationship|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.6|0.9744
70888815|NCT01848990|141263758|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.3||||0.3177|TWO_SIDED|95.0|-0.3|0.8||Sex life|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.8|-0.3|0.3177
70888816|NCT01848990|141263758|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.3||||0.2087|TWO_SIDED|95.0|-0.2|0.7||Physical appearance|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.7|-0.2|0.2087
70888817|NCT01848990|141263758|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.7907|TWO_SIDED|95.0|-0.4|0.5||Self-confidence|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.5|-0.4|0.7907
70888818|NCT01848990|141263758|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.3||||0.3444|TWO_SIDED|95.0|-0.8|0.3||Motivation|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.3|-0.8|0.3444
70888819|NCT01848990|141263758|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.2||||0.2175|TWO_SIDED|95.0|-0.1|0.6||The way people in general react|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.1|0.2175
70888820|NCT01848990|141263758|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.4||||0.2062|TWO_SIDED|95.0|-1.0|0.2||Feelings about the future|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.2|-1.0|0.2062
70888821|NCT01848990|141263758|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.8762|TWO_SIDED|95.0|-0.5|0.6||Financial situation|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.5|0.8762
70888822|NCT01848990|141263758|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.89|TWO_SIDED|95.0|-0.5|0.5||Living situation and conditions|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.5|-0.5|0.8900
70888823|NCT01848990|141263758|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.5||||0.1367|TWO_SIDED|95.0|-1.1|0.2||Depend on others|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.2|-1.1|0.1367
70888824|NCT01848990|141263758|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.3||||0.3144|TWO_SIDED|95.0|-0.3|0.9||Freedom to eat|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.9|-0.3|0.3144
70888825|NCT01848990|141263758|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.6869|TWO_SIDED|95.0|-0.4|0.6||Freedom to drink|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.4|0.6869
70888826|NCT01848990|141263759|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.9901|TWO_SIDED|95.0|-0.3|0.3|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.3|-0.3|0.9901
70888827|NCT01848990|141263760|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.9081|TWO_SIDED|95.0|-1.1|1.3||DTSQs|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||1.3|-1.1|0.9081
70888828|NCT01848990|141263760|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.984|TWO_SIDED|95.0|-1.5|1.6||DTSQc|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||1.6|-1.5|0.9840
70888829|NCT02755831|141263776|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||Fisher's Exact Test||||<0.05
70888830|NCT02755831|141263777|OTHER||||||<|0.05|||||||Friedman test|Friedman's test was used to analyze differences with a post hoc Wilcoxon Ranked Sign test to compare differences at individual time points.||||||<.05
70888831|NCT02755831|141263778|OTHER||||||<|0.05|||||||Friedman|Friedman's test was used to analyze differences with a post hoc Wilcoxon Ranked Sign test to compare differences at individual time points.||||||<0.05
70888832|NCT02755831|141263779|OTHER||||||<|0.05|||||||Friedman Test|Friedman's test was used to analyze differences with a post hoc Wilcoxon Ranked Sign test to compare differences in treatment group only.||||||<0.05
70888833|NCT02755831|141263780|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|T-test used to compare mean difference in hospital costs at time of delivery.||||||<0.05
70888834|NCT01720069|141263781|SUPERIORITY|||||||0.772|||||||ANCOVA|||||||0.772
70888835|NCT01720069|141263782|SUPERIORITY|||||||0.891|||||||ANCOVA|||||||0.891
70888836|NCT01720069|141263783|SUPERIORITY|||||||0.066|||||||ANCOVA|||||||0.066
70888837|NCT01720069|141263784|SUPERIORITY|||||||0.063|||||||ANCOVA|||||||0.063
70888838|NCT01720069|141263785|SUPERIORITY|||||||0.054|||||||ANCOVA|||||||0.054
70888839|NCT01720069|141263786|SUPERIORITY|||||||0.168|||||||Fisher Exact|||||||0.168
70888840|NCT01720069|141263786|SUPERIORITY|||||||0.363|||||||Fisher Exact|||||||0.363
70888841|NCT01720069|141263786|SUPERIORITY|||||||0.805|||||||Fisher Exact|||||||0.805
70888842|NCT00508742|141263788|SUPERIORITY_OR_OTHER||Rate Ratio|0.56|||||TWO_SIDED|95.0|0.47|0.65||||||||0.65|0.47|
70888843|NCT00508742|141263789|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6|||||TWO_SIDED|95.0|0.5|0.9||||||Month 7: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.||0.9|0.5|
70888844|NCT00508742|141263789|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6|||||TWO_SIDED|95.0|0.4|0.7||||||Month 12: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.||0.7|0.4|
70888845|NCT00508742|141263789|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4|||||TWO_SIDED|95.0|0.3|0.5||||||Month 13: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.||0.5|0.3|
70888846|NCT00508742|141263789|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.4|0.7||||||Month 18: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.||0.7|0.4|
70888847|NCT00508742|141263789|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.4|0.8||||||Month 24: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.||0.8|0.4|
70888848|NCT01312766|141263848|NON_INFERIORITY_OR_EQUIVALENCE|The one-way Analysis of Variance with Least-Squares means was performed to calculate the 95% Confidence Interval of the difference between the two treatments. If the lower bound of the 95% Confidence Interval of the difference between means (hMG-IBSA minus Menopur®) was greater than -2.1, then hMG-IBSA would be considered to be not-inferior to the comparator.|Mean Difference (Final Values)|1.9||||0.012|TWO_SIDED|95.0|0.43|3.43|||ANOVA|||||3.43|0.43|0.012
70888849|NCT01312766|141263849|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||ANOVA|||||||0.25
70888850|NCT01312766|141263851|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Fisher Exact|||||||0.90
70888851|NCT01312766|141263852|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||ANOVA|||||||0.02
70888852|NCT01312766|141263855|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Fisher Exact|||||||0.61
70888853|NCT01312766|141263856|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANOVA|||||||0.002
70888854|NCT01312766|141263857|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||ANOVA|||||||0.004
70888855|NCT01312766|141263858|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
70888856|NCT01312766|141263859|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||ANOVA|||||||0.04
70888857|NCT01312766|141263860|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Fisher Exact|||||||0.61
70888858|NCT02139644|141263894|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.154||||0.0076|TWO_SIDED|95.0|0.041|0.267|||ANCOVA|Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the first in the sequence.||0.267|0.041|0.0076
70888859|NCT02139644|141263894|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.131||||0.0322|TWO_SIDED|95.0|0.011|0.25|||ANCOVA|Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the second in the sequence.||0.250|0.011|0.0322
70888860|NCT02139644|141263894|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.335||||0|TWO_SIDED|95.0|0.216|0.453|||ANCOVA|Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the third in the sequence.||0.453|0.216|0.0000
70888861|NCT02139644|141263894|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.325||||0|TWO_SIDED|95.0|0.203|0.447|||ANCOVA|Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the fourth in the sequence.||0.447|0.203|0.0000
70888862|NCT02139644|141263895|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.262||||0|TWO_SIDED|95.0|0.168|0.356|||ANCOVA|Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the fifth in the sequence.||0.356|0.168|0.0000
70888863|NCT02139644|141263895|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.266||||0|TWO_SIDED|95.0|0.172|0.36|||ANCOVA|Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the sixth in the sequence.||0.360|0.172|0.0000
70888864|NCT02139644|141263895|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.151||||0.0017|TWO_SIDED|95.0|0.057|0.244|||ANCOVA|Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the seventh in the sequence.||0.244|0.057|0.0017
70888865|NCT02139644|141263895|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.119||||0.0132|TWO_SIDED|95.0|0.025|0.212|||ANCOVA|Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the eighth in the sequence.||0.212|0.025|0.0132
70888866|NCT02139644|141263896|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|10.926||||0.0123|TWO_SIDED|95.0|2.38|19.471||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||19.471|2.380|0.0123
70888867|NCT02139644|141263896|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|7.018||||0.1074|TWO_SIDED|95.0|-1.531|15.567||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||15.567|-1.531|0.1074
70888868|NCT02139644|141263896|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|20.824||||0|TWO_SIDED|95.0|12.253|29.395||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||29.395|12.253|0.0000
70888869|NCT02139644|141263896|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|21.273||||0|TWO_SIDED|95.0|12.728|29.818||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||29.818|12.728|0.0000
70888870|NCT02139644|141263896|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|9.898||||0.0233|TWO_SIDED|95.0|1.349|18.447||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||18.447|1.349|0.0233
70888871|NCT02139644|141263896|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|14.255||||0.0011|TWO_SIDED|95.0|5.732|22.778||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||22.778|5.732|0.0011
70888872|NCT02139644|141263896|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|10.347||||0.0175|TWO_SIDED|95.0|1.822|18.872||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||18.872|1.822|0.0175
70888873|NCT02139644|141263897|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.165||||0.0002|TWO_SIDED|95.0|-0.251|-0.08||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.080|-0.251|0.0002
70888874|NCT02139644|141263897|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.143||||0.001|TWO_SIDED|95.0|-0.229|-0.058||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.058|-0.229|0.0010
70888875|NCT02139644|141263897|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.23||||0|TWO_SIDED|95.0|-0.315|-0.144||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.144|-0.315|0.0000
70888876|NCT02139644|141263897|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.194||||0|TWO_SIDED|95.0|-0.279|-0.109||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.109|-0.279|0.0000
70888877|NCT02139644|141263897|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.064||||0.1381|TWO_SIDED|95.0|-0.15|0.021||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.021|-0.150|0.1381
70888878|NCT02139644|141263897|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.051||||0.2438|TWO_SIDED|95.0|-0.136|0.035||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.035|-0.136|0.2438
70888879|NCT02139644|141263897|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.029||||0.5095|TWO_SIDED|95.0|-0.114|0.057||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.057|-0.114|0.5095
70888880|NCT02139644|141263898|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.463||||0.0004|TWO_SIDED|95.0|-0.716|-0.209||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.209|-0.716|0.0004
70888881|NCT02139644|141263898|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.464||||0.0003|TWO_SIDED|95.0|-0.718|-0.211||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.211|-0.718|0.0003
70888882|NCT02139644|141263898|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.675||||0|TWO_SIDED|95.0|-0.928|-0.421||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.421|-0.928|0.0000
70888883|NCT02139644|141263898|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.704||||0|TWO_SIDED|95.0|-0.957|-0.45||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.450|-0.957|0.0000
70888884|NCT02139644|141263898|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.212||||0.1014|TWO_SIDED|95.0|-0.465|0.042||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.042|-0.465|0.1014
70888885|NCT02139644|141263898|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.239||||0.064|TWO_SIDED|95.0|-0.492|0.014||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.014|-0.492|0.0640
70888886|NCT02139644|141263898|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.241||||0.0626|TWO_SIDED|95.0|-0.494|0.013||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.013|-0.494|0.0626
70888887|NCT02139644|141263899|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1679||||||Significance level of 0.05|Log Rank|||||||0.1679
70888888|NCT02139644|141263899|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1701||||||Significance level of 0.05|Log Rank|||||||0.1701
70888889|NCT02139644|141263899|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0437||||||Significance level of 0.05|Log Rank|||||||0.0437
70888890|NCT02139644|141263899|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1718||||||Significance level of 0.05|Log Rank|||||||0.1718
70888891|NCT02139644|141263899|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3134||||||Significance level of 0.05|Log Rank|||||||0.3134
70888892|NCT02139644|141263899|SUPERIORITY_OR_OTHER_LEGACY|||||||0.993||||||Significance level of 0.05|Log Rank|||||||0.9930
70888893|NCT02139644|141263899|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9999||||||Significance level of 0.05|Log Rank|||||||0.9999
70888894|NCT02139644|141263900|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.301||||0.0044|TWO_SIDED|95.0|0.094|0.508||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.508|0.094|0.0044
70888895|NCT02139644|141263900|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.253||||0.0155|TWO_SIDED|95.0|0.048|0.458||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.458|0.048|0.0155
70888896|NCT02139644|141263900|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.473||||0|TWO_SIDED|95.0|0.27|0.676||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.676|0.270|0.0000
70888897|NCT02139644|141263900|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.23||||0.0293|TWO_SIDED|95.0|0.023|0.437||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.437|0.023|0.0293
70888898|NCT02139644|141263900|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.172||||0.0913|TWO_SIDED|95.0|-0.028|0.372||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.372|-0.028|0.0913
70888899|NCT02139644|141263900|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.023||||0.8216|TWO_SIDED|95.0|-0.223|0.177||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.177|-0.223|0.8216
70888900|NCT02139644|141263900|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.071||||0.4934|TWO_SIDED|95.0|-0.275|0.133||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.133|-0.275|0.4934
70888901|NCT02033889|141263975|SUPERIORITY||Difference in Least Squares Means|-0.88|||<|0.001|TWO_SIDED|95.0|-1.05|-0.71|||Constrained Longitudinal Data Analysis||||Based on Constrained Longitudinal Data Analysis (cLDA) model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another anti-hyperglycemic agent, AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.|-0.71|-1.05|<0.001
70888902|NCT02033889|141263975|SUPERIORITY||Difference in Least Squares Means|-0.7|||<|0.001|TWO_SIDED|95.0|-0.87|-0.53|||Constrained Longitudinal Data Analysis||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another anti-hyperglycemic agent, AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.|-0.53|-0.87|<0.001
70888903|NCT02033889|141263977|OTHER||Difference in % vs Placebo/Glimepiride|1.5|||||TWO_SIDED|95.0|-2.1|5.4|||||||Miettinen \& Nurminen method was used to construct the 95% CI|5.4|-2.1|
70888904|NCT02033889|141263977|OTHER||Difference in % vs Placebo/Glimepiride|1.0|||||TWO_SIDED|95.0|-2.5|4.7|||||||Miettinen \& Nurminen method was used to construct the 95% CI|4.7|-2.5|
70888905|NCT02033889|141263978|SUPERIORITY||Difference in Least Squares Means|-38.25|||<|0.001|TWO_SIDED|95.0|-44.5|-31.99|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.|-31.99|-44.50|<0.001
70888906|NCT02033889|141263978|SUPERIORITY||Difference in the Least Squares Means|-26.69|||<|0.001|TWO_SIDED|95.0|-32.9|-20.48|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.|-20.48|-32.90|<0.001
70888907|NCT02033889|141263979|SUPERIORITY||Difference in Least Squares Means|-1.6|||<|0.001|TWO_SIDED|95.0|-2.16|-1.03|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.|-1.03|-2.16|<0.001
70888908|NCT02033889|141263979|SUPERIORITY||Difference in Least Squares Means|-1.67|||<|0.001|TWO_SIDED|95.0|-2.24|-1.11|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.|-1.11|-2.24|<0.001
70888909|NCT02033889|141263980|SUPERIORITY||Adjusted Odds Ratio Relative to Placebo|4.48|||<|0.001|TWO_SIDED|95.0|2.64|7.62|||Regression, Logistic||||Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), menopausal status, covariates for baseline A1C and baseline eGFR (continuous). Missing data imputed using a multiple imputation procedure based on cLDA prediction modeling with fixed effects as in the primary analysis, which allows for participants with missing data to be included in the analysis.|7.62|2.64|<0.001
70888910|NCT02033889|141263980|SUPERIORITY||Adjusted Odds Ratio Relative to Placebo|3.03|||<|0.001|TWO_SIDED|95.0|1.81|5.06|||Regression, Logistic||||Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), menopausal status, covariates for baseline A1C and baseline eGFR (continuous). Missing data imputed using a multiple imputation procedure based on cLDA prediction modeling with fixed effects as in the primary analysis, which allows for participants with missing data to be included in the analysis.|5.06|1.81|<0.001
70888911|NCT02033889|141263981|SUPERIORITY||Difference in Least Squares Means|-4.5|||<|0.001|TWO_SIDED|95.0|-6.81|-2.19|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|-2.19|-6.81|<0.001
70888912|NCT02033889|141263981|SUPERIORITY||Difference in Least Squares Means|-3.68||||0.002|TWO_SIDED|95.0|-5.96|-1.39|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|-1.39|-5.96|0.002
70888913|NCT02033889|141263982|SUPERIORITY||Difference in Least Squares Means|-2.42||||0.001|TWO_SIDED|95.0|-3.86|-0.98|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|-0.98|-3.86|0.001
70888914|NCT02033889|141263982|SUPERIORITY||Difference in Least Squares Means|-1.82||||0.013|TWO_SIDED|95.0|-3.24|-0.39|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|-0.39|-3.24|0.013
70888915|NCT02033889|141263983|SUPERIORITY||Adjusted Odds Ratio|5.41|||<|0.001|TWO_SIDED|95.0|2.1|13.9|||Regression, Logistic||||Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), menopausal status, covariates for baseline A1C and baseline eGFR (continuous). Missing data imputed using a multiple imputation procedure based on cLDA prediction modeling with fixed effects as in the primary analysis, which allows for participants with missing data to be included in the analysis.|13.90|2.10|<0.001
70888916|NCT02033889|141263983|SUPERIORITY||Adjusted Odds Ratio|3.1||||0.023|TWO_SIDED|95.0|1.17|8.22|||Regression, Logistic||||Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), menopausal status, covariates for baseline A1C and baseline eGFR (continuous). Missing data imputed using a multiple imputation procedure based on cLDA prediction modeling with fixed effects as in the primary analysis, which allows for participants with missing data to be included in the analysis.|8.22|1.17|0.023
70888917|NCT02033889|141263984|SUPERIORITY||Difference in % vs Placebo|-16.2|||<|0.001|TWO_SIDED|95.0|-22.2|-11.2|||Miettinen & Nurminen method|Miettinen \& Nurminen method was used to construct both the 95% CI and derive p-value for the difference between the proportions (i.e. percentages).||||-11.2|-22.2|<0.001
70888918|NCT02033889|141263984|SUPERIORITY||Difference in % vs Placebo|-14.8|||<|0.001|TWO_SIDED|95.0|-20.9|-9.4|||Miettinen & Nurminen method.|Miettinen \& Nurminen method was used to construct both the 95% CI and derive p-value for the difference between the proportions (i.e. percentages).||||-9.4|-20.9|<0.001
70888919|NCT02033889|141264003|OTHER||Difference in the Least Squares Means|-0.1|||||TWO_SIDED|95.0|-0.71|0.5|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.50|-0.71|
70888920|NCT02033889|141264003|OTHER||Difference in the Least Squares Means|-0.23|||||TWO_SIDED|97.0|-0.83|0.37|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.37|-0.83|
70888921|NCT02033889|141264004|OTHER||Difference in the Least Squares Means|0.7|||||TWO_SIDED|95.0|0.0|1.39|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|1.39|0.00|
70888922|NCT02033889|141264004|OTHER||Difference in the Least Squares Means|0.3|||||TWO_SIDED|95.0|-0.38|0.99|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.99|-0.38|
70888923|NCT02033889|141264005|OTHER||Difference in the Least Squares Means|0.27|||||TWO_SIDED|95.0|-0.15|0.68|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.68|-0.15|
70888924|NCT02033889|141264005|OTHER||Difference in the Least Squares Means|0.08|||||TWO_SIDED|95.0|-0.33|0.48|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.48|-0.33|
70888925|NCT02033889|141264006|OTHER||Difference in the Least Squares Means|-0.19|||||TWO_SIDED|95.0|-0.76|0.39|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.39|-0.76|
70888926|NCT02033889|141264006|OTHER||Difference in the Least Squares Means|-0.21|||||TWO_SIDED|95.0|-0.78|0.35|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.35|-0.78|
70888927|NCT02033889|141264010|OTHER||Difference in the Least Squares Means|0.17|||||TWO_SIDED|95.0|-0.53|0.88|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.88|-0.53|
70888928|NCT02033889|141264010|OTHER||Difference in the Least Squares Means|-0.18|||||TWO_SIDED|97.0|-0.88|0.51|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.51|-0.88|
70888929|NCT02033889|141264011|OTHER||Difference in the Least Squares Means|0.25|||||TWO_SIDED|95.0|-0.48|0.98|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.98|-0.48|
70888930|NCT02033889|141264011|OTHER||Difference in the Least Squares Means|0.2|||||TWO_SIDED|95.0|-0.51|0.91|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.91|-0.51|
70888931|NCT02033889|141264012|OTHER||Difference in the Least Squares Means|-0.5|||||TWO_SIDED|95.0|-0.95|-0.04|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|-0.04|-0.95|
70888932|NCT02033889|141264012|OTHER||Difference in the Least Squares Means|-0.22|||||TWO_SIDED|95.0|-0.66|0.23|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.23|-0.66|
70888933|NCT02033889|141264013|OTHER||Difference in the Least Squares Means|0.06|||||TWO_SIDED|95.0|-0.61|0.72|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.72|-0.61|
70888934|NCT02033889|141264013|OTHER||Difference in the Least Squares Means|-0.15|||||TWO_SIDED|95.0|-0.78|0.49|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.49|-0.78|
70888935|NCT02033889|141264017|OTHER||Difference in the Least Squares Means|-0.23|||||TWO_SIDED|95.0|-1.01|0.56|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.56|-1.01|
70888936|NCT02033889|141264017|OTHER||Difference in the Least Squares Means|-0.28|||||TWO_SIDED|97.0|-1.06|0.5|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.50|-1.06|
70888937|NCT02033889|141264018|OTHER||Difference in the Least Squares Means|0.27|||||TWO_SIDED|95.0|-0.58|1.13|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|1.13|-0.58|
70888938|NCT02033889|141264018|OTHER||Difference in the Least Squares Means|0.12|||||TWO_SIDED|95.0|-0.7|0.93|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.93|-0.70|
70888939|NCT02033889|141264019|OTHER||Difference in the Least Squares Means|-0.84|||||TWO_SIDED|95.0|-1.44|-0.24|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|-0.24|-1.44|
70888940|NCT02033889|141264019|OTHER||Difference in the least Squares Means|-0.54|||||TWO_SIDED|95.0|-1.12|0.05|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.05|-1.12|
70888941|NCT02033889|141264020|OTHER||Difference in the Least Squares Means|-0.06|||||TWO_SIDED|95.0|-0.77|0.65|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.65|-0.77|
70888942|NCT02033889|141264020|OTHER||Difference in the Least Squares Means|0.18|||||TWO_SIDED|95.0|-0.5|0.85|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.85|-0.50|
70888943|NCT03143829|141264027|OTHER|||||||0.083|||||||t-test, 2 sided|||Differences at week 10||||0.083
70888944|NCT03143829|141264028|OTHER|||||||0.099|||||||t-test, 2 sided|||Descriptive comparison||||.099
70888945|NCT03143829|141264029|OTHER|||||||0.558|||||||t-test, 2 sided|||comparison at time 4||||.558
70888946|NCT03143829|141264030|OTHER|||||||0.153|||||||Chi-squared|||descriptive comparison of resource use||||.153
70888947|NCT02391948|141264033|OTHER||mean population value age 12|98.3|||||TWO_SIDED|95.0|97.8|98.6||||||||98.6|97.8|
70888948|NCT02391948|141264033|OTHER||mean population value age 12|89.1|||||TWO_SIDED|95.0|86.6|91.1||||||||91.1|86.6|
70888949|NCT02391948|141264033|OTHER||mean population value age 12|50.1|||||TWO_SIDED|95.0|46.5|53.6||||||||53.6|46.5|
70888950|NCT02391948|141264033|OTHER||mean population value age 12|25.3|||||TWO_SIDED|95.0|23.7|27.0||||||||27.0|23.7|
70888951|NCT02391948|141264033|OTHER||mean population value age 12|6.48|||||TWO_SIDED|95.0|5.66|7.38||||||||7.38|5.66|
70888952|NCT02391948|141264034|OTHER||mean population value age 12|0.44|||||TWO_SIDED|95.0|0.38|0.49||||||||0.49|0.38|
70888953|NCT02391948|141264034|OTHER||mean population value age 12|0.68|||||TWO_SIDED|95.0|0.6|0.77||||||||0.77|0.60|
70888954|NCT02391948|141264034|OTHER||mean population value age 12|0.93|||||TWO_SIDED|95.0|0.79|1.07||||||||1.07|0.79|
70888955|NCT02391948|141264034|OTHER||mean population value age 12|1.38|||||TWO_SIDED|95.0|1.22|1.54||||||||1.54|1.22|
70888956|NCT02391948|141264034|OTHER||mean population value age 12|2.16|||||TWO_SIDED|95.0|2.01|2.31||||||||2.31|2.01|
70888957|NCT02391948|141264035|OTHER||mean population value|4.49|||||TWO_SIDED|95.0|4.43|4.54||||||||4.54|4.43|
70888958|NCT02391948|141264035|OTHER||mean population value|4.1|||||TWO_SIDED|95.0|3.99|4.2||||||||4.20|3.99|
70888959|NCT02391948|141264035|OTHER||mean population value|3.99|||||TWO_SIDED|95.0|3.75|4.25||||||||4.25|3.75|
70888960|NCT02391948|141264035|OTHER||mean population value|2.95|||||TWO_SIDED|95.0|2.73|3.19||||||||3.19|2.73|
70888961|NCT02391948|141264035|OTHER||mean population value|1.59|||||TWO_SIDED|95.0|1.44|1.75||||||||1.75|1.44|
70888962|NCT02391948|141264036|OTHER||mean population value|1362.3|||||TWO_SIDED|95.0|1313.6|1410.7||||||||1410.7|1313.6|
70888963|NCT02391948|141264036|OTHER||mean population value|1096.33|||||TWO_SIDED|95.0|1028.8|1158.62||||||||1158.62|1028.80|
70888964|NCT02391948|141264036|OTHER||mean population value|592.62|||||TWO_SIDED|95.0|533.79|652.72||||||||652.72|533.79|
70888965|NCT02391948|141264037|OTHER||mean population value|3.99|||||TWO_SIDED|95.0|3.91|4.07||||||||4.07|3.91|
70888966|NCT02391948|141264037|OTHER||mean population value|3.49|||||TWO_SIDED|95.0|3.39|3.6||||||||3.60|3.39|
70888967|NCT02391948|141264037|OTHER||mean population value|3.23|||||TWO_SIDED|95.0|3.08|3.37||||||||3.37|3.08|
70888968|NCT02391948|141264037|OTHER||mean population value|2.8|||||TWO_SIDED|95.0|2.67|2.93||||||||2.93|2.67|
70888969|NCT02391948|141264037|OTHER||mean population value|1.79|||||TWO_SIDED|95.0|1.67|1.91||||||||1.91|1.67|
70888970|NCT02391948|141264038|OTHER||mean population value|0.59|||||TWO_SIDED|9.0|0.47|0.72||||||||0.72|0.47|
70888971|NCT02391948|141264038|OTHER||mean population value|1.1|||||TWO_SIDED|95.0|0.91|1.3||||||||1.30|0.91|
70888972|NCT02391948|141264038|OTHER||mean population value|0.68|||||TWO_SIDED|95.0|0.48|0.89||||||||0.89|0.48|
70888973|NCT02391948|141264038|OTHER||mean population value|1.38|||||TWO_SIDED|95.0|1.12|1.65||||||||1.65|1.12|
70888974|NCT02391948|141264038|OTHER||mean population value|2.33|||||TWO_SIDED|95.0|2.08|2.6||||||||2.60|2.08|
70888975|NCT02391948|141264039|OTHER||mean population value age 12|70.6|||||TWO_SIDED|95.0|69.1|72.0||||||||72.0|69.1|
70888976|NCT02391948|141264039|OTHER||mean population value age 12|62.1|||||TWO_SIDED|95.0|59.4|65.0||||||||65.0|59.4|
70888977|NCT02391948|141264039|OTHER||mean population value age 12|62.9|||||TWO_SIDED|95.0|60.9|65.0||||||||65.0|60.9|
70888978|NCT02391948|141264039|OTHER||mean population value age 12|58.2|||||TWO_SIDED|95.0|56.7|59.7||||||||59.7|56.7|
70888979|NCT02391948|141264039|OTHER||mean population value age 12|51.9|||||TWO_SIDED|95.0|50.2|53.6||||||||53.6|50.2|
70888980|NCT02391948|141264040|OTHER||mean population value age 12|78.3|||||TWO_SIDED|95.0|76.0|80.4||||||||80.4|76.0|
70888981|NCT02391948|141264040|OTHER||mean population value age 12|66.1|||||TWO_SIDED|95.0|63.5|68.5||||||||68.5|63.5|
70888982|NCT02391948|141264040|OTHER||mean population value age 12|60.5|||||TWO_SIDED|95.0|57.3|63.3|||mean population value age 12|||||63.3|57.3|
70888983|NCT02391948|141264040|OTHER||mean population value age 12|37.9|||||TWO_SIDED|95.0|35.6|40.3||||||||40.3|35.6|
70888984|NCT02391948|141264040|OTHER||mean population value age 12|14.5|||||TWO_SIDED|95.0|12.4|16.5||||||||16.5|12.4|
70888985|NCT02391948|141264041|OTHER||Odds Ratio (OR)|1.46|||||TWO_SIDED|95.0|1.06|2.02|||||Data from all GMFCS levels was used, country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in family-centredness outcome.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor family-centred service.||2.02|1.06|
70888986|NCT02391948|141264041|OTHER||Odds Ratio (OR)|1.48|||||TWO_SIDED|95.0|1.07|2.03|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor parents' perception of needs being met.||2.03|1.07|
70888987|NCT02391948|141264041|OTHER||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.96|1.38|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in the amount of focus on environment.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor degree of focus on environment (assistive devices, equipment, home/school modifications).||1.38|0.96|
70888988|NCT02391948|141264041|OTHER||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|1.07|1.58|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in focus on participation.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor focus on participation (structured play/recreation/leisure activities).||1.58|1.07|
70888989|NCT02391948|141264041|OTHER||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.72|1.58|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in amount of physical therapy services.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor amount of physical therapy services.||1.58|0.72|
70888990|NCT02391948|141264041|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.74|1.28|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in amount of occupational therapy services.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor amount of occupational therapy.||1.28|0.74|
70888991|NCT02391948|141264041|OTHER||Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.97|1.6|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in amount of speech and language therapy.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor amount of speech and language therapy.||1.60|0.97|
70888992|NCT02391948|141264041|OTHER||Odds Ratio (OR)|1.37|||||TWO_SIDED|95.0|1.0|1.88|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor family-centred service.||1.88|1.00|
70888993|NCT02391948|141264041|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.78|1.44|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor family-centred service.||1.44|0.78|
70888994|NCT02391948|141264041|OTHER||Odds Ratio (OR)|0.83|||||TWO_SIDED|95.0|0.54|1.26|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor family-centred service.||1.26|0.54|
70888995|NCT02391948|141264041|OTHER||Odds Ratio (OR)|1.37|||||TWO_SIDED|95.0|1.0|1.87|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor parents' perception of needs being met.||1.87|1.00|
70888996|NCT02391948|141264041|OTHER||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.83|1.53|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor parents' perception of needs being met.||1.53|0.83|
70888997|NCT02391948|141264041|OTHER||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.59|1.3|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor parents' perception of needs being met.||1.3|0.59|
70888998|NCT02391948|141264041|OTHER||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.9|1.29|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor degree of focus on environment (assistive devices, equipment, home/school modifications).||1.29|0.9|
70888999|NCT02391948|141264041|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.86|1.22||||||Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor degree of focus on environment (assistive devices, equipment, home/school modifications).||1.22|0.86|
70889000|NCT02391948|141264041|OTHER||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.7|1.13|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor degree of focus on environment (assistive devices, equipment, home/school modifications).||1.13|0.7|
70889001|NCT02391948|141264041|OTHER||Odds Ratio (OR)|1.09|||||TWO_SIDED|95.0|0.9|1.31|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor focus on participation (structured play/recreation/leisure activities).||1.31|0.9|
70889002|NCT02391948|141264041|OTHER||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.91|1.32|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor focus on participation (structured play/recreation/leisure activities).||1.32|0.91|
70889003|NCT02391948|141264041|OTHER||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.76|1.24|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor focus on participation (structured play/recreation/leisure activities).||1.24|0.76|
70889004|NCT02391948|141264041|OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.7|1.15|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor amount of physical therapy services.||1.15|.7|
70889005|NCT02391948|141264041|OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.74|1.48|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor amount of physical therapy services.||1.48|.74|
70889006|NCT02391948|141264041|OTHER||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.72|1.21|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life -Self Care outcome for the predictor amount of occupational therapy.||1.21|.72|
70889007|NCT02391948|141264041|OTHER||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.89|1.5|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor amount of occupational therapy.||1.5|.89|
70889008|NCT02391948|141264041|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.65|1.38|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor amount of occupational therapy.||1.38|.65|
70889009|NCT02391948|141264041|OTHER||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.81|1.31|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor amount of speech and language therapy.||1.31|.81|
70889010|NCT02391948|141264041|OTHER||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.87|1.39|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor amount of speech and language therapy.||1.39|.87|
70889011|NCT02391948|141264041|OTHER||Odds Ratio (OR)|0.86|||||TWO_SIDED|95.0|0.6|1.25|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor amount of speech and language therapy.||1.25|.6|
70889012|NCT02391948|141264041|OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.92|1.53|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor amount of physical therapy services.||1.53|.92|
70889013|NCT02391948|141264045|OTHER||population average|2319.0|||||TWO_SIDED|95.0|1460.0|3218.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||3218|1460|
70889014|NCT02391948|141264045|OTHER||population average|1858.0|||||TWO_SIDED|95.0|1233.0|2530.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||2530|1233|
70889015|NCT02391948|141264046|OTHER||population average|5240.0|||||TWO_SIDED|95.0|3874.0|6670.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||6670|3874|
70889016|NCT02391948|141264046|OTHER||population average|4319.0|||||TWO_SIDED|95.0|3258.0|5443.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||5443|3258|
70889017|NCT02391948|141264047|OTHER||population average|108.0|||||TWO_SIDED|95.0|67.0|151.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||151|67|
70889018|NCT02391948|141264047|OTHER||population average|100.0|||||TWO_SIDED|95.0|58.0|145.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||145|58|
70889019|NCT02391948|141264047|OTHER||population average|10.0|||||TWO_SIDED|95.0|0.0|35.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model. This analysis combined children in GMFCS Levels III-V.||35|0|
70889020|NCT02391948|141264048|OTHER||population average|2815.0|||||TWO_SIDED|95.0|2025.0|3650.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||3650|2025|
70889021|NCT02391948|141264048|OTHER||population average|3109.0|||||TWO_SIDED|95.0|2502.0|3739.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||3739|2502|
70889022|NCT02391948|141264048|OTHER||population average|1056.0|||||TWO_SIDED|95.0|471.0|1665.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model. This analysis combined children in GMFCS Levels III-V.||1665|471|
70889023|NCT01176591|141264058|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08|||||||t-test, 2 sided|||||||0.08
70889024|NCT01176591|141264059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08|||||||t-test, 2 sided|||||||0.08
70889025|NCT01176591|141264060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046|||||||t-test, 2 sided|||||||0.046
70889026|NCT01176591|141264061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|||||||t-test, 2 sided|||||||0.039
70889027|NCT01176591|141264063|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035|||||||t-test, 2 sided|||||||0.035
70889028|NCT00982319|141264064|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
70889029|NCT01923181|141264066|SUPERIORITY|This hypothesis was controlled for multiplicity.|Mean treatment difference|-1.47|||<|0.0001|TWO_SIDED|95.0|-1.73|-1.22|||Mixed Models Analysis||Oral semaglutide 40 mg pooled - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-1.22|-1.73|<0.0001
70889030|NCT01923181|141264066|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-0.4||||0.0069|TWO_SIDED|95.0|-0.69|-0.11|||Mixed Models Analysis||Oral semaglutide 2.5 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-0.11|-0.69|0.0069
70889031|NCT01923181|141264066|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-0.89|||<|0.0001|TWO_SIDED|95.0|-1.18|-0.6|||Mixed Models Analysis||Oral semaglutide 5 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-0.60|-1.18|<0.0001
70889032|NCT01923181|141264066|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.18|||<|0.0001|TWO_SIDED|95.0|-1.47|-0.9|||Mixed Models Analysis||Oral semaglutide 10 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-0.90|-1.47|<0.0001
70889033|NCT01923181|141264066|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.38|||<|0.0001|TWO_SIDED|95.0|-1.68|-1.09|||Mixed Models Analysis||Oral Semaglutide 20 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-1.09|-1.68|<0.0001
70889034|NCT01923181|141264066|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.6|||<|0.0001|TWO_SIDED|95.0|-1.89|-1.3|||Mixed Models Analysis||Oral semaglutide 40 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-1.30|-1.89|<0.0001
70889035|NCT01923181|141264066|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.43|||<|0.0001|TWO_SIDED|95.0|-1.72|-1.14|||Mixed Models Analysis||Oral semaglutide 40 mg slow dose-escalation - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-1.14|-1.72|<0.0001
70889036|NCT01923181|141264066|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.64|-1.04|||Mixed Models Analysis||Oral semaglutide 40 mg fast dose-escalation - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-1.04|-1.64|<0.0001
70889037|NCT01923181|141264066|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.56|||<|0.0001|TWO_SIDED|95.0|-1.85|-1.27|||Mixed Models Analysis||Subcutaneous semaglutide 1 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-1.27|-1.85|<0.0001
70889038|NCT01923181|141264066|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|1.16|||<|0.0001|TWO_SIDED|95.0|0.87|1.45|||Mixed Models Analysis||Oral semaglutide 2.5 mg - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||1.45|0.87|<0.0001
70889039|NCT01923181|141264066|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.67|||<|0.0001|TWO_SIDED|95.0|0.38|0.96|||Mixed Models Analysis||Oral semaglutide 5 mg - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.96|0.38|<0.0001
70889040|NCT01923181|141264066|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.37||||0.0116|TWO_SIDED|95.0|0.08|0.67|||Mixed Models Analysis||Oral semaglutide 10 mg - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.67|0.08|0.0116
70889041|NCT01923181|141264066|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.18||||0.244|TWO_SIDED|95.0|-0.12|0.47|||Mixed Models Analysis||Oral semaglutide 20 mg - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.47|-0.12|0.2440
70889042|NCT01923181|141264066|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-0.04||||0.7973|TWO_SIDED|95.0|-0.34|0.26|||Mixed Models Analysis||Oral semaglutide 40 mg - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.26|-0.34|0.7973
70889043|NCT01923181|141264066|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.13||||0.3901|TWO_SIDED|95.0|-0.16|0.42|||Mixed Models Analysis||Oral semaglutide 40 mg slow-dose escalation - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.42|-0.16|0.3901
70889044|NCT01923181|141264066|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.22||||0.1612|TWO_SIDED|95.0|-0.09|0.52|||Mixed Models Analysis||Oral semaglutide 40 mg fast-dose escalation - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.52|-0.09|0.1612
70889045|NCT01923181|141264066|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.17||||0.2669|TWO_SIDED|95.0|-0.13|0.46|||Mixed Models Analysis||Oral semaglutide 40 mg slow-dose escalation - Oral semaglutide 40 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.46|-0.13|0.2669
70889046|NCT01923181|141264066|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.26||||0.0989|TWO_SIDED|95.0|-0.05|0.56|||Mixed Models Analysis||Oral semaglutide 40 mg fast-dose escalation - Oral semaglutide 40 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.56|-0.05|0.0989
70889047|NCT01923181|141264066|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.09||||0.5565|TWO_SIDED|95.0|-0.21|0.39|||Mixed Models Analysis||Oral semaglutide 40 mg fast-dose escalation - Oral semaglutide 40 mg slow-dose escalation|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.39|-0.21|0.5565
70889048|NCT01863446|141264073|SUPERIORITY|Unpaired t-test comparing Lighting 1 and Lighting2||||||0.334|||||||t-test, 2 sided|||||||0.334
70889049|NCT01863446|141264073|SUPERIORITY|Unpaired t-test comparing Lighting3 vs Lighting 4||||||0.423|||||||t-test, 2 sided|||||||0.423
70889050|NCT01863446|141264074|SUPERIORITY|Unpaired t-test of Lighting1 vs Lighting2||||||0.78|||||||t-test, 2 sided|||||||0.780
70889051|NCT01863446|141264074|SUPERIORITY|Unpaired t-test of Lighting3 vs Lighting4||||||0.791|||||||t-test, 2 sided|||||||0.791
70889052|NCT01863446|141264075|SUPERIORITY|Unpaired t-test||||||0.883|||||||t-test, 2 sided|||||||0.883
70889053|NCT01863446|141264075|SUPERIORITY|Unpaired t-test||||||0.271|||||||t-test, 2 sided|||||||0.271
70889054|NCT02312310|141264076|SUPERIORITY|Test of trend across doses.||||||0.393|||||||Mixed Models Analysis|Change in outcome from baseline to 12 weeks tested using mixed effects models controlling for baseline measures, treatment, sex, age, and education.|||The flavanol effect on the change in each outcome from baseline to 12 weeks was tested using linear mixed effects models controlling for the respective baseline measures, four categories of treatment, sex, age, and education. Regression adjusted mean within-group tests of change were estimated and tested for statistical significance from the model. The primary test used for assessing the treatment effect was the linear trend contrast from the model across: placebo, low, medium and high dose. The model for cognitive measures incorporated additional outcome measurement times at 4 weeks and 20 weeks and included categorical time (4, 12, 20 weeks) as a predictor as well as a treatment (4 category) by time interaction, and a random intercept to control for repeated measures within individuals (results for 4 and 20 weeks not presented).|||.393
70889055|NCT00563797|141264083|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED|||||F=7.73|Mixed Models Analysis|||Comparison is between baseline and during treatment.||||0.014
70889056|NCT00563797|141264084|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||F=36.32|Mixed Models Analysis|||Comparison of baseline and post-treatment||||.0001
70889057|NCT00563797|141264085|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED||||||Mixed Models Analysis|||||||.025
70889058|NCT00563797|141264086|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||Mixed Models Analysis|||||||.019
70889059|NCT00807092|141264089|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.013|STANDARD_ERROR_OF_MEAN|0.666||||95.0|-1.332|1.306||A statistical significant threshold p less than 0.025|ANCOVA|Treatment and strata as factors; baseline (visit 2) value of mean IAUC(0-4hours) as covariate|BIAsp 30 - BHI 30|"The null hypothesis (H0) was:~H0: Change in mean IAUC(0-4hours) of BIAsp 30 after 6 weeks of treatment-Change in mean IAUC(0-4hours) of BHI 30 after 6 weeks of treatment greater than or equal to 0 mol\*h/L against the alternative hypothesis(H1): H1: Change in mean IAUC (0-4hours) of BIAsp 30 after 6 weeks of treatment-Change in mean IAUC(0-4hours) of BHI 30 after 6 weeks of treatment less than 0 mol\*h/L"||1.306|-1.332|
70889060|NCT00807092|141264090|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.178|STANDARD_ERROR_OF_MEAN|1.0||0.2412||95.0|-0.802|3.157||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; corresponding baseline (week 0) value of mean IAUC(0-4h) as covariate (breakfast/lunch/dinner)|Breakfast|"Null hypothesis and alternative hypothesis for breakfast:~The null hypothesis (H0) was:~H0: Change in mean IAUC(0-4h) of BIAsp 30 for breakfast after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for breakfast after 6 weeks of treatment =0 mol\*h/L against the alternative hypothesis(H1): H1: Change in mean IAUC (0-4h) of BIAsp 30 for breakfast after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for breakfast after 6 weeks of treatment≠0 mol\*h/L"||3.157|-0.802|0.2412
70889061|NCT00807092|141264090|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.318|STANDARD_ERROR_OF_MEAN|1.216||0.794||95.0|-2.724|2.087||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; corresponding baseline (week 0) value of mean IAUC(0-4h) as covariate (breakfast/lunch/dinner)|Lunch|"Null hypothesis and alternative hypothesis for lunch:~The null hypothesis (H0) was:~H0: Change in mean IAUC(0-4h) of BIAsp 30 for lunch after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for lunch after 6 weeks of treatment =0 mol\*h/L against the alternative hypothesis(H1): H1: Change in mean IAUC (0-4h) of BIAsp 30 for lunch after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for lunch after 6 weeks of treatment≠0 mol\*h/L"||2.087|-2.724|0.794
70889062|NCT00807092|141264090|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.749||||0.3093||95.0|-2.2|0.703||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; corresponding baseline (week 0) value of mean IAUC(0-4h) as covariate (breakfast/lunch/dinner)|Dinner|"Null hypothesis and alternative hypothesis for dinner:~The null hypothesis (H0) was:~H0: Change in mean IAUC(0-4h) of BIAsp 30 for dinner after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for dinner after 6 weeks of treatment =0 mol\*h/L against the alternative hypothesis(H1): H1: Change in mean IAUC (0-4h) of BIAsp 30 for dinner after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for dinner after 6 weeks of treatment≠0 mol\*h/L"||0.703|-2.2|0.3093
70889063|NCT00807092|141264091|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.448|STANDARD_ERROR_OF_MEAN|0.261||0.0891||95.0|-0.069|0.964||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of mean FBG as covariate||"The null hypothesis (H0) was:~H0: Change in mean FBG of BIAsp 30 after 6 weeks of treatment-Change in mean FBG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in mean FBG of BIAsp 30 after 6 weeks of treatment-Change in mean FBG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.964|-0.069|0.0891
70889064|NCT00807092|141264093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.495|STANDARD_ERROR_OF_MEAN|0.247||0.0472||95.0|0.006|0.984||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of mean FBG as covariate||"The null hypothesis (H0) was:~H0: Change in FPG of BIAsp 30 after 6 weeks of treatment-Change in FPG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in FPG of BIAsp 30 after 6 weeks of treatment-Change in FPG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.984|0.0060|0.0472
70889065|NCT00807092|141264094|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.676||95.0|-0.41|0.63||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 2) value of BG as covariate|Before breakfast|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.63|-0.41|0.676
70889066|NCT00807092|141264094|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.23||||0.026||95.0|0.15|2.31||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|2 hours after breakfast|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||2.31|0.15|0.026
70889067|NCT00807092|141264094|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27||||0.5||95.0|-0.53|1.08||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|Before lunch|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||1.08|-0.53|0.5
70889068|NCT00807092|141264094|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.747||95.0|-0.86|1.19||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|2 hours after lunch|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||1.19|-0.86|0.747
70889069|NCT00807092|141264094|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.581||95.0|-1.23|0.69||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|Before dinner|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.69|-1.23|0.581
70889070|NCT00807092|141264094|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.326||95.0|-1.42|0.48||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|2 hours after dinner|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.48|-1.42|0.326
70889071|NCT00807092|141264094|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.19||||0.643||95.0|-0.61|0.99||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|Bedtime|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.99|-0.61|0.643
70889072|NCT00807092|141264094|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77||||0.008||95.0|0.21|1.33||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|3 AM|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||1.33|0.21|0.0080
70889073|NCT00807092|141264094|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27||||0.274||95.0|-0.22|0.75||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|Average|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.75|-0.22|0.274
70889074|NCT00807092|141264095|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.99||||0.062||95.0|-0.05|2.04||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of prandial BG increment as covariate|Breakfast|"For each endpoint of Prandial Blood Glucose Increment :The null hypothesis (H0) was:~H0: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment≠0 mmol/L"||2.04|-0.05|0.062
70889075|NCT00807092|141264095|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.933||95.0|-1.12|1.22||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of prandial BG increment as covariate|Lunch|"For each endpoint of Prandial Blood Glucose Increment :The null hypothesis (H0) was:~H0: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment≠0 mmol/L"||1.22|-1.12|0.933
70889076|NCT00807092|141264095|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.922||95.0|-1.16|1.05||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of prandial BG increment as covariate|Dinner|"For each endpoint of Prandial Blood Glucose Increment :The null hypothesis (H0) was:~H0: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment≠0 mmol/L"||1.05|-1.16|0.922
70889077|NCT00807092|141264095|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.29||||0.313||95.0|-0.28|0.85||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of prandial BG increment as covariate|Average|"For each endpoint of Prandial Blood Glucose Increment :The null hypothesis (H0) was:~H0: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.85|-0.28|0.313
70889078|NCT00807092|141264096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.187|STANDARD_ERROR_OF_MEAN|0.371||0.6149||95.0|-0.547|0.921||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (visit 2) value of mean MAGE as covariate||The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products.||0.921|-0.547|0.6149
70889079|NCT00807092|141264097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.328|STANDARD_ERROR_OF_MEAN|0.577||0.5706||95.0|-0.813|1.468||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of GA as covariate||"The null hypothesis (H0) was:~H0: Change in GA of BIAsp 30 after 6 weeks of treatment-Change in GA of BHI 30 after 6 weeks of treatment =0 % against the alternative hypothesis(H1): H1: Change in GA of BIAsp 30 after 6 weeks of treatment-Change in GA of BHI 30 after 6 weeks of treatment≠0 %"||1.468|-0.813|0.5706
70889080|NCT00807092|141264098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.113||0.8598||95.0|-0.243|0.243||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of HbA1c as covariate||"The null hypothesis (H0) was:~H0: Change in HbA1c of BIAsp 30 after 6 weeks of treatment-Change in HbA1c of BHI 30 after 6 weeks of treatment =0 % against the alternative hypothesis(H1): H1: Change in HbA1c of BIAsp 30 after 6 weeks of treatment-Change in HbA1c of BHI 30 after 6 weeks of treatment≠0%"||0.243|-0.243|0.8598
70889081|NCT00807092|141264099|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.054|STANDARD_ERROR_OF_MEAN|0.128||0.671||95.0|-0.307|0.198||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of duration of hypoglycaemic events as covariate|Blood glucose below 3.5 mmol/l|"The null hypothesis (H0) was:~H0: Duration of Hypoglycaemic Events Based on CGMS of BIAsp 30 after 6 weeks of treatment-Duration of Hypoglycaemic Events Based on CGMS of BHI 30 after 6 weeks of treatment =0 hours against the alternative hypothesis(H1): H1: Duration of Hypoglycaemic Events Based on CGMS of BIAsp 30 after 6 weeks of treatment-Duration of Hypoglycaemic Events Based on CGMS of BHI 30 after 6 weeks of treatment≠0 hours"||0.198|-0.307|0.671
70889082|NCT00807092|141264099|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.012|STANDARD_ERROR_OF_MEAN|0.038||0.7544||95.0|-0.088|0.064||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of duration of hypoglycaemic events as covariate|Blood glucose below 2.5 mmol/l|"The null hypothesis (H0) was:~H0: Duration of Hypoglycaemic Events Based on CGMS of BIAsp 30 after 6 weeks of treatment-Duration of Hypoglycaemic Events Based on CGMS of BHI 30 after 6 weeks of treatment =0 hours against the alternative hypothesis(H1): H1: Duration of Hypoglycaemic Events Based on CGMS of BIAsp 30 after 6 weeks of treatment-Duration of Hypoglycaemic Events Based on CGMS of BHI 30 after 6 weeks of treatment≠0 hours"||0.064|-0.088|0.7544
70889083|NCT04116229|141264101|EQUIVALENCE|"Alternative hypothesis: people with normal-weight BMI have lower DBSI restricted fraction, or putative cellularity, than people with obesity.~Null hypothesis: DBSI restricted fraction, or putative cellularity, is not different between normal-weight and obese groups."|Median Difference (Final Values)|0.05||||0.28|TWO_SIDED|||||a priori threshold: p \< 0.05|Independent-Samples Median Test|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.||||0.28
70889084|NCT04116229|141264101|EQUIVALENCE|"Alternative hypothesis: people with normal-weight BMI have lower DBSI hindered fraction, or putative vasogenic edema, than people with obesity.~Null hypothesis: DBSI hindered fraction, or putative vasogenic edema, is not different between normal-weight and obese groups."|Median Difference (Final Values)|0.18||||0.03|TWO_SIDED|||||a priori threshold: p \< 0.05|Independent-Samples Median Test|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.||||0.03
70889085|NCT04116229|141264102|OTHER|"Alternative hypothesis: Worse crystallized cognitive function will relate to greater putative vasogenic edema (DBSI HF) in white matter tracts.~Null hypothesis: Crystallized cogntive function is not related to DBSI HF."|Slope|-0.69||||0.01|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.01
70889086|NCT04116229|141264102|OTHER|"Alternative hypothesis: Worse fluid cognitive function will relate to greater putative vasogenic edema (DBSI HF) in white matter tracts.~Null hypothesis: Fluid cogntive function is not related to DBSI HF."|Slope|0.52||||0.1|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.10
70889087|NCT04116229|141264102|OTHER|"Alternative hypothesis: Worse crystallized cognitive function will relate to greater putative cellularity (DBSI RF) in white matter tracts.~Null hypothesis: Crystallized cognitive function is not related to DBSI RF."|Slope|-0.45||||0.01|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.01
70889088|NCT04116229|141264102|OTHER|"Alternative hypothesis: Worse fluid cognitive function will relate to greater putative cellularity (DBSI RF) in white matter tracts.~Null hypothesis: Fluid cognitive function is not related to DBSI RF."|Slope|0.22||||0.1|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.10
70889089|NCT04116229|141264103|OTHER|"Alternative hypothesis: higher levels of insulin, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: Insulin levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|-0.18|||>|0.46|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||>0.46
70889090|NCT04116229|141264103|OTHER|"Alternative hypothesis: higher levels of insulin, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: Insulin levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|-0.22|||>|0.5|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||>0.5
70889091|NCT04116229|141264104|OTHER|"Alternative hypothesis: higher levels of leptin, a pro-inflammatory marker and satiety hormone, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: Leptin levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|0.15||||0.62|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.62
70889092|NCT04116229|141264104|OTHER|"Alternative hypothesis: higher levels of leptin, a pro-inflammatory marker and satiety hormone, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: Leptin levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|-0.07||||0.82|TWO_SIDED||||||Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.82
70889093|NCT04116229|141264105|OTHER|"Alternative hypothesis: higher levels of ghrelin, an anti-inflammatory marker and hunger hormone, will relate to lower levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: Ghrelin levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|0.19||||0.53|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.53
70889094|NCT04116229|141264105|OTHER|"Alternative hypothesis: higher levels of ghrelin, an anti-inflammatory marker and hunger hormone, will relate to lower levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: Ghrelin levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|-0.12||||0.71|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.71
70889095|NCT04116229|141264106|OTHER|"Alternative hypothesis: greater HOMA-IR, where higher HOMA-IR indicates greater insulin resistance, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: HOMA-IR levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|-0.19||||0.53|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.53
70889096|NCT04116229|141264106|OTHER|"Alternative hypothesis: greater HOMA-IR, where higher HOMA-IR indicates greater insulin resistance, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: HOMA-IR levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|-0.21||||0.5|TWO_SIDED||||||Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.5
70889097|NCT04116229|141264107|OTHER|"Alternative hypothesis: higher levels of IL-10, an anti-inflammatory marker, will relate to lower levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: IL-10 levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|0.5||||0.09|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.09
70889098|NCT04116229|141264107|OTHER|"Alternative hypothesis: higher levels of IL-10, an anti-inflammatory marker, will relate to lower levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: IL-10 levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|-0.2||||0.45|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.45
70889099|NCT04116229|141264108|OTHER|"Alternative hypothesis: higher levels of adiponectin, an anti-inflammatory marker, will relate to lower levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: Adiponectin levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|0.38||||0.19|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.19
70889100|NCT04116229|141264108|OTHER|"Alternative hypothesis: higher levels of adiponectin, an anti-inflammatory marker, will relate to lower levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: Adiponectin levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|-0.2||||0.52|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.52
70889101|NCT04116229|141264109|OTHER|"Alternative hypothesis: higher levels of TNF-alpha, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: TNF-alpha levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|-0.05||||0.9|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.90
70889102|NCT04116229|141264109|OTHER|"Alternative hypothesis: higher levels of TNF-alpha, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: TNF-alpha levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|0.04||||0.87|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.87
70889103|NCT04116229|141264110|OTHER|"Alternative hypothesis: higher levels of MCP-1, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: MCP-1 levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|0.34||||0.26|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.26
70889104|NCT04116229|141264110|OTHER|"Alternative hypothesis: higher levels of MCP-1, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: MCP-1 levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|0.12||||0.71|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.71
70889105|NCT04116229|141264111|OTHER|"Alternative hypothesis: higher levels of CRP, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: CRP levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|0.19||||0.54|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.54
70889106|NCT04116229|141264111|OTHER|"Alternative hypothesis: higher levels of CRP, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: CRP levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|0.09||||0.77|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.77
70889107|NCT05209191|141264125|SUPERIORITY||Mean Difference (Net)|7.28|STANDARD_DEVIATION|0.65||0.001|TWO_SIDED||||||t-test, 2 sided|||||||.001
70889108|NCT05209191|141264127|SUPERIORITY||Mean Difference (Net)|0.08||||0.38|TWO_SIDED||||||t-test, 2 sided|||Paired t-test.||||.38
70889109|NCT05209191|141264128|SUPERIORITY||Chi square|52.07||||0.001|TWO_SIDED||||||Chi-squared|||||||.001
70889110|NCT01229228|141264129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.417|STANDARD_ERROR_OF_MEAN|2.7891|<|0.001|TWO_SIDED|95.0|16.923|27.91|||ANCOVA|||||27.910|16.923|<0.001
70889111|NCT02443298|141264130|SUPERIORITY||Hazard Ratio (HR)|1.46||||0.0255|TWO_SIDED|80.0|1.18|1.81|||Cox proportional hazards model||Comparison of Risankizumab to Placebo|This was analyzed by using a Cox proportional hazards model that included treatment and the stratification factor of OCS use at baseline as fixed effects.||1.81|1.18|0.0255
70889112|NCT02443298|141264131|SUPERIORITY||Hazard Ratio (HR)|1.47||||0.0131|TWO_SIDED|80.0|1.2|1.79|||Cox proportional hazards model||Comparison of Risankizumab to Placebo|This was analyzed by using a Cox proportional hazards model that included treatment and the stratification factor of OCS use at baseline as fixed effects.||1.79|1.20|0.0131
70889113|NCT02443298|141264132|SUPERIORITY||Rate Ratio|1.4937|STANDARD_ERROR_OF_MEAN|0.22||0.0065|TWO_SIDED|80.0|1.2366|1.8044|||Negative binomial regression||Comparison of Risankizumab to Placebo|Annualized rate is obtained from fitting a negative binomial regression including logarithm of the exposure as an offset, treatment, and OCS use at baseline as covariate.||1.8044|1.2366|0.0065
70889114|NCT02443298|141264133|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.4619|TWO_SIDED|80.0|0.88|1.57|||Cox proportional hazards model||Comparison of Risankizumab to Placebo|Time to first event is obtained from fitting a Cox proportional-hazards model including treatment, and OCS use at baseline as covariate||1.57|0.88|0.4619
70889115|NCT02443298|141264134|SUPERIORITY||Rate Ratio|1.1317|STANDARD_ERROR_OF_MEAN|0.237||0.555|TWO_SIDED|80.0|0.8652|1.4803|||Negative binomial regression||Comparison of Risankizumab to Placebo|Annualized rate is obtained from fitting a negative binomial regression including logarithm of the exposure as an offset, treatment, and OCS use at baseline as covariate.||1.4803|0.8652|0.5550
70889116|NCT02443298|141264135|SUPERIORITY||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|0.051||0.4423|TWO_SIDED|80.0|-0.104|0.026|||Mixed Models Analysis|Unstructured covariance structure for within-patient variation|Comparison of Risankizumab to Placebo|The adjusted mean (SE) are obtained from fitting a mixed effect repeated measures (MMRM) model including treatment, OCS use at baseline, test day, treatment-by-test day interaction, baseline, and baseline-by-test day interaction as covariates patient as a random effect.||0.026|-0.104|0.4423
70889117|NCT02443298|141264136|SUPERIORITY||Mean Difference (Final Values)|-0.068|STANDARD_ERROR_OF_MEAN|0.045||0.1377|TWO_SIDED|80.0|-0.126|-0.009|||Mixed Models Analysis|Unstructured covariance structure for within-patient variation|Comparison of Risankizumab to Placebo|The adjusted mean (SE) are obtained from fitting a mixed effect repeated measures (MMRM) model including treatment, OCS use at baseline, test day, treatment-by-test day interaction, baseline, and baseline-by-test day interaction as covariates patient as a random effect.||-0.009|-0.126|0.1377
70889118|NCT02443298|141264137|SUPERIORITY||Mean Difference (Final Values)|0.149|STANDARD_ERROR_OF_MEAN|0.115||0.1985|TWO_SIDED|80.0|0.0|0.297|||ANCOVA||Comparison of Risankizumab to Placebo|The adjusted mean (SE) are obtained from fitting an analysis of covariance (ANCOVA) model separately for each week including treatment, OCS use at baseline, and baseline as covariates. The weekly averages of daily measurements are calculated before fitting the model.||0.297|0.000|0.1985
70889119|NCT03759223|141264139|SUPERIORITY|||||||0.04||||||0:24 weeks|Mixed Models Analysis|||||||.04
70889120|NCT03759223|141264139|SUPERIORITY|||||||0.05||||||0:24 weeks|Mixed Models Analysis|||||||.05
70889121|NCT03759223|141264139|SUPERIORITY|||||||0.58||||||12:12 weeks|Mixed Models Analysis|||||||.58
70889122|NCT03698773|141264152|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
70889123|NCT03698773|141264153|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
70889124|NCT00908960|141264154|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|6.7||||0.06|TWO_SIDED|95.0|1.03|43.17|||Fine and Gray regression|||||43.17|1.03|0.06
70889125|NCT05074433|141264157|SUPERIORITY||Hazard Ratio (HR)|0.563|||||TWO_SIDED|95.0|0.093|3.393|||Cox proportional hazard model|||||3.393|0.093|
70889126|NCT05074433|141264157|SUPERIORITY||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.072|2.929|||Cox proportional hazard model|||||2.929|0.072|
70889127|NCT05074433|141264157|SUPERIORITY||Cox Proportional Hazard|0.609|||||TWO_SIDED|95.0|0.101|3.668|||Cox proportional hazard model|||||3.668|0.101|
70889128|NCT02248922|141264207|OTHER|||||||0.4099|||||||ANOVA|||||||0.4099
70889129|NCT02248922|141264208|OTHER|||||||0.6961|||||||ANOVA|||||||0.6961
70889130|NCT02248922|141264209|OTHER|||||||0.354|||||||ANOVA|||||||0.3540
70889131|NCT02248922|141264210|OTHER|||||||0.591|||||||ANOVA|||||||0.5910
70889132|NCT02248922|141264211|OTHER|||||||0.4249|||||||ANOVA|||||||0.4249
70889133|NCT02248922|141264212|OTHER|||||||0.3963|||||||ANOVA|||||||0.3963
70889134|NCT02248922|141264213|OTHER|||||||0.3502|||||||ANOVA|||||||0.3502
70889135|NCT02822794|141264214|SUPERIORITY||||||<|0.001|||||||Binomial test|P-value is obtained from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL+RBV 12 Weeks (GT1) over the performance goal of 50%.||||||<0.001
70889136|NCT02822794|141264214|SUPERIORITY||||||<|0.001|||||||Binomial test|P-value is obtained from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL +RBV 24 Weeks (GT1) over the performance goal of 50%.||||||<0.001
70889137|NCT03056690|141264243|SUPERIORITY|Mixed model repeated measures (MMRM) analysis model is performed with change from baseline (Week 8) as response; treatment, center (pooled where necessary), time (week 8) and treatment\*time as fixed effects, baseline and baseline\*time as covariates.|LSMean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.25||0.086|TWO_SIDED|90.0|-0.76|0.07|||MMRM|||||0.07|-0.76|0.086
70889138|NCT03056690|141264249|SUPERIORITY||Difference|0.2||||0.551|TWO_SIDED|90.0|-11.9|12.5|||Fisher Exact|CI for each treatment group and the difference of the proportions is an exact unconditional confidence interval based on Santner-Snell approach.||||12.5|-11.9|0.551
70889139|NCT03056690|141264250|SUPERIORITY||Difference|6.9||||0.202|TWO_SIDED|90.0|-5.2|19.1|||Fisher Exact|CI for each treatment group and the difference of the proportions is an exact unconditional confidence interval based on Santner-Snell approach.||||19.1|-5.2|0.202
70889140|NCT03056690|141264251|SUPERIORITY||Difference|1.7||||0.451|TWO_SIDED|90.0|-10.5|13.8|||Fisher Exact|CI for each treatment group and the difference of the proportions is an exact unconditional confidence interval based on Santner-Snell approach.||||13.8|-10.5|0.451
70889141|NCT03056690|141264252|SUPERIORITY||Difference|6.1||||0.174|TWO_SIDED|90.0|-6.2|18.1|||Fisher Exact|CI for each treatment group and the difference of the proportions is an exact unconditional confidence interval based on Santner-Snell approach.||||18.1|-6.2|0.174
70889142|NCT03056690|141264253|SUPERIORITY||Least Square (LS) Mean difference|-1.48|STANDARD_ERROR_OF_MEAN|2.04||0.235|TWO_SIDED|90.0|-4.86|1.9||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Function Subscale: Week 2||1.90|-4.86|0.235
70889143|NCT03056690|141264253|SUPERIORITY||LSMean Difference|-2.97|STANDARD_ERROR_OF_MEAN|2.34||0.103|TWO_SIDED|90.0|-6.84|0.89||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Function Subscale: Week 4||0.89|-6.84|0.103
70889144|NCT03056690|141264253|SUPERIORITY||LSMean Difference|-2.59|STANDARD_ERROR_OF_MEAN|2.53||0.154|TWO_SIDED|90.0|-6.78|1.6||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Function Subscale: Week 8||1.60|-6.78|0.154
70889145|NCT03056690|141264253|SUPERIORITY||LSMean Difference|-1.34|STANDARD_ERROR_OF_MEAN|1.88||0.238|TWO_SIDED|90.0|-4.45|1.77||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Symptoms Subscale: Week 2||1.77|-4.45|0.238
70889146|NCT03056690|141264253|SUPERIORITY||LSMean Difference|-3.73|STANDARD_ERROR_OF_MEAN|2.11||0.039|TWO_SIDED|90.0|-7.22|-0.24||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Symptoms Subscale: Week 4||-0.24|-7.22|0.039
70889147|NCT03056690|141264253|SUPERIORITY||LSMean Difference|-3.06|STANDARD_ERROR_OF_MEAN|2.34||0.097|TWO_SIDED|90.0|-6.93|0.81||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Symptoms Subscale: Week 8||0.81|-6.93|0.097
70889148|NCT03056690|141264253|SUPERIORITY||LSMean DIfference|-0.99|STANDARD_ERROR_OF_MEAN|0.63||0.057|TWO_SIDED|90.0|-2.03|0.04||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Overall Impact Subscale: Week 2||0.04|-2.03|0.057
70889149|NCT03056690|141264253|SUPERIORITY||LSMean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.63||0.018|TWO_SIDED|90.0|-2.39|-0.29||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Overall Impact Subscale: Week 4||-0.29|-2.39|0.018
70889150|NCT03056690|141264253|SUPERIORITY||LSMean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.7||0.111|TWO_SIDED|90.0|-2.02|0.3||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Overall Impact Subscale: Week 8||0.30|-2.02|0.111
70889151|NCT03056690|141264254|SUPERIORITY||LSMean difference|-3.15|STANDARD_ERROR_OF_MEAN|2.36||0.092|TWO_SIDED|90.0|-7.05|0.75||ANCOVA model is performed with change from baseline at the EOT timepoint as response treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.|ANCOVA|||Function Subscale||0.75|-7.05|0.092
70889152|NCT03056690|141264254|SUPERIORITY||LSMean difference|-3.29|STANDARD_ERROR_OF_MEAN|2.16||0.065|TWO_SIDED|90.0|-6.85|0.28||ANCOVA model is performed with change from baseline at the EOT timepoint as response treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.|ANCOVA|||Symptoms subscale||0.28|-6.85|0.065
70889153|NCT03056690|141264254|SUPERIORITY||LSMean difference|-1.08|STANDARD_ERROR_OF_MEAN|0.65||0.049|TWO_SIDED|90.0|-2.15|-0.01||ANCOVA model is performed with change from baseline at the EOT timepoint as response treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.|ANCOVA|||Overall Impact Subscale.||-0.01|-2.15|0.049
70889154|NCT03056690|141264255|SUPERIORITY|The 90% 2-sided CI is based on profile likelihood and 2-sided p-value is based on likelihood test. p-value is for the comparison of ASP0819 15 mg with Placebo from the above described proportional odds model.|Odds Ratio (OR)|1.43||||0.192|TWO_SIDED|90.0|0.91|2.24|||Likelihood test|||Week 2||2.24|0.91|0.192
70889155|NCT03056690|141264255|SUPERIORITY||Odds Ratio (OR)|1.33||||0.285|TWO_SIDED|90.0|0.86|2.07||The 90% 2-sided CI is based on profile likelihood and 2-sided p-value is based on likelihood test. p-value is for the comparison of ASP0819 15 mg with Placebo from the above described proportional odds model.|Likelihod test|||Week 4||2.07|0.86|0.285
70889156|NCT03056690|141264255|SUPERIORITY||Odds Ratio (OR)|1.2||||0.486|TWO_SIDED|90.0|0.78|1.87||The 90% 2-sided CI is based on profile likelihood and 2-sided p-value is based on likelihood test. p-value is for the comparison of ASP0819 15 mg with Placebo from the above described proportional odds model.|Likelihood test|||EOT||1.87|0.78|0.486
70889157|NCT03056690|141264256|SUPERIORITY|The 90% 2-sided CI is based on profile likelihood and 2-sided p-value is based on likelihood test.|Odds Ratio (OR)|1.32||||0.305|TWO_SIDED|90.0|0.85|2.05|||Likelihood test|||Week 8||2.05|0.85|0.305
70889158|NCT02442700|141264257|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
70889159|NCT01591681|141264266|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||Sample size was computed to be 45 participants using the system for 42 nights (21 nights with system active and 21 control nights) for a total of 1,890 nights in order to have 90% power with a type 1 error rate of 5% to reject the null hypothesis of no difference in nocturnal hypoglycemia assuming a true population rate of 30% of control nights and 15% of intervention nights with hypoglycemia after adjusting for the correlation from repeated nights and misclassification due to sensor inaccuracy.||||<0.001
70889160|NCT01591681|141264267|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|repeated measures logistic regression|Was used to test differences using mixed effects and a within subject autocorrelation structure to account for multiple nights from the same subject.||||||<0.001
70889161|NCT01591681|141264268|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||||||<0.001
70889162|NCT01591681|141264269|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||||||<0.001
70889163|NCT01591681|141264270|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||||||<0.001
70889164|NCT01591681|141264271|SUPERIORITY_OR_OTHER|||||||0.71||||||The a priori threshold for statistical significance is 0.05.|repeated measures logistic regression|Was used to test differences using mixed effects and a within subject autocorrelation structure to account for multiple nights from the same subject.||||||0.71
70889165|NCT01591681|141264272|SUPERIORITY_OR_OTHER|||||||0.62||||||The a priori threshold for statistical significance is 0.05.|repeated measures logistic regression|Was used to test differences using mixed effects and a within subject autocorrelation structure to account for multiple nights from the same subject.||||||0.62
70889166|NCT01591681|141264273|SUPERIORITY_OR_OTHER|||||||0.1||||||The a priori threshold for statistical significance is 0.05.|repeated measures logistic regression|Was used to test differences using mixed effects and a within subject autocorrelation structure to account for multiple nights from the same subject.||||||0.10
70889167|NCT01591681|141264274|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||||||<0.001
70889168|NCT01591681|141264275|SUPERIORITY_OR_OTHER|||||||0.98||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||||||0.98
70889169|NCT01591681|141264276|SUPERIORITY_OR_OTHER|||||||0.93||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||||||0.93
70889170|NCT02486406|141264310|SUPERIORITY||Wilson's score method|98.4|||||TWO_SIDED|95.0|91.7|99.7||||||According to the Highlights of Prescribing Information of PEGASYS, the SVR24 rate was 47% among 45 treatment-naïve pediatric participants with HCV GT1 in the NV17424 trial. To show that the DAA regimen is superior to this current standard of care by 20%, the lower bound of the 2-sided 95% confidence interval of the SVR12 rate across all participants in the study must be greater than 67%.||99.7|91.7|
70889171|NCT03062891|141264343|SUPERIORITY||Slope|0.54||||0.572|TWO_SIDED|95.0|-1.33|2.4|||Regression, Linear|||This analysis looked at the interaction between baseline anxiety symptoms and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||2.40|-1.33|.572
70889172|NCT03062891|141264344|SUPERIORITY||Slope|0.08||||0.934|TWO_SIDED|95.0|-1.82|1.98|||Regression, Linear|||This analysis looked at the interaction between baseline depression symptoms and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||1.98|-1.82|.934
70889173|NCT03062891|141264345|SUPERIORITY||Slope|1.07||||0.253|TWO_SIDED|95.0|-0.76|2.89|||Regression, Linear|||This analysis looked at the interaction between attentional problems and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||2.89|-0.76|.253
70889174|NCT03062891|141264346|SUPERIORITY||Slope|1.2||||0.215|TWO_SIDED|95.0|-0.7|3.1|||Regression, Linear|||This analysis looked at the interaction between baseline paranois and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||3.10|-0.70|.215
70889175|NCT03062891|141264346|SUPERIORITY||Slope|1.14||||0.254|TWO_SIDED|95.0|-0.83|3.11|||Regression, Linear|||This analysis looked at the interaction between baseline hallucinations and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||3.11|-0.83|.254
70889176|NCT03062891|141264346|SUPERIORITY||Slope|-0.27||||0.778|TWO_SIDED|95.0|-2.13|1.59|||Regression, Linear|||This analysis looked at the interaction between baseline cognitive disorganization and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||1.59|-2.13|.778
70889177|NCT03062891|141264347|SUPERIORITY||Slope|-0.25||||0.8|TWO_SIDED|95.0|-2.16|1.67|||Regression, Linear|||This analysis looked at the interaction between baseline positive mental health and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||1.67|-2.16|.800
70889178|NCT03062891|141264348|SUPERIORITY||Slope|0.59||||0.525|TWO_SIDED|95.0|-1.25|2.44|||Regression, Linear|||This analysis looked at the interaction between baseline perceived stress and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||2.44|-1.25|.525
70889179|NCT03062891|141264349|SUPERIORITY||Slope|1.3||||0.14|TWO_SIDED|95.0|-0.43|3.03|||Regression, Linear|||This analysis looked at the interaction between baseline threatening life events and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||3.03|-0.43|.140
70889180|NCT03062891|141264350|SUPERIORITY||Slope|-2.58||||0.03|TWO_SIDED|95.0|-4.9|-0.25|||Generalized estimating equation|||This analysis looked at the effect of group on changes in anxiety symptoms across the intervention period.||-0.25|-4.90|.030
70889181|NCT03062891|141264351|SUPERIORITY||Slope|-0.63||||0.456|TWO_SIDED|95.0|-2.24|1.01|||Generalized estimating equation|||This analysis looked at the effect of group on changes in depression symptoms across the intervention period.||1.01|-2.24|.456
70889182|NCT03062891|141264352|SUPERIORITY||Slope|-2.34||||0.11|TWO_SIDED|95.0|-5.21|0.53|||Generalized estimating equation|||This analysis looked at the effect of group on changes attentional problems across the intervention period.||0.53|-5.21|.110
70889183|NCT03062891|141264353|SUPERIORITY||Slope|-1.69||||0.041|TWO_SIDED|95.0|-3.31|-0.07|||Generalized estimating equations|||This analysis looked at the effect of group on changes in psychotic experiences (paranoia) across the intervention period.||-0.07|-3.31|.041
70889184|NCT03062891|141264353|SUPERIORITY||Slope|-0.22||||0.531|TWO_SIDED|95.0|-0.92|0.48|||Generalized estimating equation|||This analysis looked at the effect of group on changes in psychotic experiences (hallucinations) across the intervention period.||0.48|-0.92|.531
70889185|NCT03062891|141264353|SUPERIORITY||Slope|-0.37||||0.13|TWO_SIDED|95.0|-0.84|0.11|||Generalized estimating equation|||This analysis looked at the effect of group on changes in psychotic experiences (cognitive disorganization) across the intervention period.||0.11|-0.84|.130
70889186|NCT03062891|141264354|SUPERIORITY||Slope|0.07||||0.916|TWO_SIDED|95.0|-1.17|1.3|||Generalized estimating equation|||This analysis looked at the effect of group on changes in positive mental health across the intervention period.||1.30|-1.17|.916
70889187|NCT03062891|141264355|SUPERIORITY||Slope|-2.03||||0.027|TWO_SIDED|95.0|-3.83|-0.23|||Generalized estimating equation|||This analysis looked at the effect of group on changes in perceived stress across the intervention period.||-0.23|-3.83|.027
70889188|NCT03062891|141264357|SUPERIORITY||Odds Ratio (OR)|1.36||||0.296|TWO_SIDED|95.0|0.77|2.4|||Regression, Logistic|||Assocation between baseline anxiety symptoms and exploding head syndrome||2.40|0.77|.296
70889189|NCT03062891|141264357|SUPERIORITY||Odds Ratio (OR)|0.69||||0.065|TWO_SIDED|95.0|0.47|1.02|||Regression, Logistic|||Assocation between baseline insomnia symptoms and exploding head syndrome||1.02|0.47|.065
70889190|NCT03062891|141264357|SUPERIORITY||Odds Ratio (OR)|0.67||||0.145|TWO_SIDED|95.0|0.39|1.15|||Regression, Logistic|||Assocation between baseline depression symptoms and exploding head syndrome||1.15|0.39|.145
70889191|NCT03062891|141264357|SUPERIORITY||Odds Ratio (OR)|1.26||||0.398|TWO_SIDED|95.0|0.73|2.19|||Regression, Logistic|||Assocation between baseline life stress and exploding head syndrome||2.19|0.73|.398
70889192|NCT03062891|141264357|SUPERIORITY||Odds Ratio (OR)|1.72||||0.001|TWO_SIDED|95.0|1.24|2.38|||Regression, Logistic|||Assocation between sleep paralysis and exploding head syndrome||2.38|1.24|.001
70889193|NCT02127307|141264358|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.446|||<|0.0001|TWO_SIDED|95.0|0.3227|0.6156||At 0.025 level of significance.|Cox proportional hazards model|||"AdreView-Heart Failure Group with H/M \<1.60 vs. H/M ≥1.60:~Data analysis was performed using Cox proportional hazards model to demonstrate the relationship of consensus numeric H/M ratio and time to adverse cardiac events to identify participants with higher risk of death. Hazard (risk) of a death for a participant with H/M ratio at time t was expressed as Hl (t)/Hh (t)=Ψ,where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.6156|0.3227|<0.0001
70889194|NCT03221257|141264359|SUPERIORITY||Mean Difference (Net)|-0.14||||0.9326|TWO_SIDED||||||Mixed Models Analysis|||||||0.9326
70889195|NCT03221257|141264360|SUPERIORITY||Mean Difference (Net)|-0.01||||0.9968|TWO_SIDED||||||Mixed Models Analysis|||||||0.9968
70889196|NCT03221257|141264361|SUPERIORITY||Mean Difference (Net)|0.46||||0.7489|TWO_SIDED||||||Mixed Models Analysis|||||||0.7489
70889197|NCT03221257|141264362|SUPERIORITY||Mean Difference (Net)|-9.2||||0.8898|TWO_SIDED||||||Mixed Models Analysis|||||||0.8898
70889198|NCT03221257|141264363|SUPERIORITY||Mean Difference (Net)|0.86||||0.3826|TWO_SIDED||||||Mixed Models Analysis|||||||0.3826
70889199|NCT03221257|141264364|SUPERIORITY||Mean Difference (Net)|-0.14||||0.2819|TWO_SIDED||||||Mixed Models Analysis|||||||0.2819
70889200|NCT03221257|141264365|SUPERIORITY||Mean Difference (Net)|-1.35||||0.7534|TWO_SIDED||||||Mixed Models Analysis|||||||0.7534
70889201|NCT03221257|141264366|SUPERIORITY||Mean Difference (Net)|-1.58||||0.1701|TWO_SIDED||||||ANCOVA|||||||0.1701
70889202|NCT03221257|141264367|SUPERIORITY||Mean Difference (Net)|-2.44||||0.3515|TWO_SIDED||||||ANCOVA|||||||0.3515
70889203|NCT03221257|141264368|SUPERIORITY||Mean Difference (Net)|-3.51||||0.1177|TWO_SIDED||||||ANCOVA|||||||0.1177
70889204|NCT03221257|141264369|SUPERIORITY||Mean Difference (Net)|-3.98||||0.1931|TWO_SIDED||||||ANCOVA|||||||0.1931
70889205|NCT03221257|141264370|SUPERIORITY||Mean Difference (Net)|121.3||||0.1811|TWO_SIDED||||||ANCOVA|||||||0.1811
70889206|NCT03221257|141264371|SUPERIORITY||Hazard Ratio (HR)|1.433||||0.3261|TWO_SIDED||||||Stratified log rank|||||||0.3261
70889207|NCT03221257|141264372|SUPERIORITY||Odds Ratio (OR)|1.6||||0.454|TWO_SIDED||||||Regression, Logistic|||||||0.454
70889208|NCT01129141|141264387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.198|STANDARD_ERROR_OF_MEAN|2.88|<|0.0001|TWO_SIDED|95.0|-22.86|-11.53|||Mixed Models Analysis|||||-11.53|-22.86|<.0001
70889209|NCT02442830|141264415|OTHER|Log rank test||||||0.002|||||||Log Rank|||||||.002
70889210|NCT01516879|141264417|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.97|STANDARD_ERROR_OF_MEAN|2.1|<|0.001|TWO_SIDED|95.0|-61.08|-52.85|||Repeated measures linear effects model|The model included treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 52 in LDL-C between evolocumab 420 mg and placebo, and the alternative hypothesis was that a mean difference did exist.||-52.85|-61.08|<0.001
70889211|NCT01516879|141264418|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.8|STANDARD_ERROR_OF_MEAN|2.3|<|0.001|TWO_SIDED|95.0|-62.3|-53.3|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-53.3|-62.3|<0.001
70889212|NCT01516879|141264419|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|75.8|||<|0.001|TWO_SIDED|95.0|70.8|79.7|||Cochran-Mantel-Haenszel|CMH test stratified by the stratification factor. For testing, non-achievement was imputed for participants with a missing value at Week 52.|Treatment difference using placebo as the reference.|||79.7|70.8|<0.001
70889213|NCT01516879|141264420|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.51|STANDARD_ERROR_OF_MEAN|1.56|<|0.001|TWO_SIDED|95.0|-60.57|-54.45|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-54.45|-60.57|<0.001
70889214|NCT01516879|141264421|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.15|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-37.19|-33.11|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-33.11|-37.19|<0.001
70889215|NCT01516879|141264422|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.45|STANDARD_ERROR_OF_MEAN|1.41|<|0.001|TWO_SIDED|95.0|-36.21|-30.68|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-30.68|-36.21|<0.001
70889216|NCT01516879|141264423|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.27|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-54.25|-46.28|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-46.28|-54.25|<0.001
70889217|NCT01516879|141264424|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.21|STANDARD_ERROR_OF_MEAN|1.71|<|0.001|TWO_SIDED|95.0|-47.56|-40.85|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-40.85|-47.56|<0.001
70889218|NCT01516879|141264425|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.14|STANDARD_ERROR_OF_MEAN|1.67|<|0.001|TWO_SIDED|95.0|-40.41|-33.87|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-33.87|-40.41|<0.001
70889219|NCT01516879|141264426|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.21|STANDARD_ERROR_OF_MEAN|1.82|<|0.001|TWO_SIDED|95.0|-49.79|-42.63|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-42.63|-49.79|<0.001
70889220|NCT01516879|141264427|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.35|STANDARD_ERROR_OF_MEAN|1.94|<|0.001|TWO_SIDED|95.0|-26.15|-18.55|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-18.55|-26.15|<0.001
70889221|NCT01516879|141264428|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-11.54|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-17.21|-5.86|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-5.86|-17.21|<0.001
70889222|NCT01516879|141264429|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|5.42|STANDARD_ERROR_OF_MEAN|1.09|<|0.001|TWO_SIDED|95.0|3.28|7.56|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||7.56|3.28|<0.001
70889223|NCT01516879|141264430|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-29.15|STANDARD_ERROR_OF_MEAN|5.64|<|0.001|TWO_SIDED|95.0|-40.23|-18.08|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-18.08|-40.23|<0.001
70889224|NCT01516879|141264431|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-0.14|STANDARD_ERROR_OF_MEAN|1.84||0.94|TWO_SIDED|95.0|-3.76|3.48|||ANCOVA|The ANCOVA model includes treatment group and stratification factor as covariates.|Treatment difference using placebo as the reference.|||3.48|-3.76|0.94
70889225|NCT02797262|141264435|SUPERIORITY||Mean Difference (Net)|0.02||||0.57|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)||Treatment Difference = Intervention - Control|Compared the IPAM score between two groups.||||0.57
70889226|NCT02797262|141264437|SUPERIORITY||Mean Difference (Net)|-0.02||||0.08|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Treatment Difference = Intervention - Control|Compared the change of the plasma HIV RNA levels during the intervention period (week 0-16) between two groups.||||0.08
70889227|NCT02797262|141264437|SUPERIORITY||Mean Difference (Net)|-0.02||||0.23|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Treatment Difference = Intervention - Control|Compared the change of the plasma HIV RNA levels during the post-intervention period (week 16-28) between two groups.||||0.23
70889228|NCT02797262|141264437|SUPERIORITY||Mean Difference (Net)|-0.73||||0.03|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Treatment Difference = Intervention - Control|Compared the plasma HIV RNA levels during week 4-28 between two groups.||||0.03
70889229|NCT00829621|141264457|SUPERIORITY_OR_OTHER||||||=|0.36|||||||t-test, 1 sided|||||||=0.36
70889230|NCT02066298|141264478|SUPERIORITY|||||||0.14|||||||exact binomial test|a priori threshold for significance was 0.025||The null hypothesis was that, among those participants for which either mometasone is not equal to placebo, the proportion for which mometasone is superior to placebo is equal to the proportion for which placebo is superior to mometasone. The trial was designed to provide power of 0.85 for a 0.20 difference between the proportions being compared at a significance level of 0.025.||||0.14
70889231|NCT02066298|141264478|SUPERIORITY|||||||0.029||||||a priori threshold for significance was 0.025|exact binomial test|||The null hypothesis was that, among those participants for which either tiotropium is not equal to placebo, the proportion for which tiotropium is superior to placebo is equal to the proportion for which placebo is superior to tiotropium. The trial was designed to provide power of 0.85 for a 0.20 difference between the proportions being compared at a significance level of 0.025.||||0.029
70889232|NCT02066298|141264478|SUPERIORITY|||||||0.001||||||this analysis is considered exploratory|exact binomial test|||The null hypothesis was that, among those participants for which either mometasone is not equal to placebo, the proportion for which mometasone is superior to placebo is equal to the proportion for which placebo is superior to mometasone. This was an exploratory analysis and there were no power considerations.||||0.001
70889233|NCT02066298|141264478|SUPERIORITY|||||||0.45||||||this analysis is considered exploratory|exact binomial test|||The null hypothesis was that, among those participants for which either tiotropium is not equal to placebo, the proportion for which tiotropium is superior to placebo is equal to the proportion for which placebo is superior to tiotropium. This was an exploratory analysis and there were no power considerations.||||0.45
70889234|NCT02873923|141264514|OTHER||Correlation coefficient|0.66|||||TWO_SIDED|95.0|0.63|0.68|||||||As of today, the meta-analytic surrogacy evaluation scheme proposed by Buyse and Burzykowski et al. is considered as the most statistically rigorous method for the validation of surrogate endpoints. This approach requires individual-patient data (IPD) from multiple randomized clinical trials (RCT) with similar design and treatment to address surrogacy from a multi-level framework. At the patient level, the surrogate endpoint should be correlated and predictive of the final endpoint regardless of the treatment (individual level association). At the trial level, the treatment effect on the surrogate endpoint should be correlated and predictive of the treatment effect on the final endpoint (trial-level association). Individual-level and trial-level associations estimated using weighted linear regression and the two-stage model introduced by Buyse and Burzykowski.|0.68|0.63|
70889235|NCT02873923|141264515|OTHER||correlation coefficient|0.0|||||TWO_SIDED|95.0|0.0|0.005|||||||As of today, the meta-analytic surrogacy evaluation scheme proposed by Buyse and Burzykowski et al. is considered as the most statistically rigorous method for the validation of surrogate endpoints. This approach requires individual-patient data (IPD) from multiple randomized clinical trials (RCT) with similar design and treatment to address surrogacy from a multi-level framework. At the patient level, the surrogate endpoint should be correlated and predictive of the final endpoint regardless of the treatment (individual level association). At the trial level, the treatment effect on the surrogate endpoint should be correlated and predictive of the treatment effect on the final endpoint (trial-level association). Individual-level and trial-level associations estimated using weighted linear regression and the two-stage model introduced by Buyse and Burzykowski.|0.005|0.00|
70889236|NCT01610700|141264520|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-5.93||||0.124||95.0|-13.52|1.65|||ANCOVA|||The change in the primary impairment was compared between treatment groups using analysis of covariance (ANCOVA) with baseline primary impairment score as the covariate.||1.65|-13.52|0.124
70889237|NCT01610700|141264521|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-7.1||||0.062|TWO_SIDED|95.0|-14.56|0.37|||ANCOVA|||The change in the spasticity visual analogue scale score was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||0.37|-14.56|0.062
70889238|NCT01610700|141264522|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.88||||0.731|TWO_SIDED|95.0|-12.73|8.96|||ANCOVA|||The change in the pain visual analogue scale score was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||8.96|-12.73|0.731
70889239|NCT01610700|141264523|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-3.3||||0.443|TWO_SIDED|95.0|-11.82|5.21|||ANCOVA|||The change in the muscle spasm visual analogue scale score was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||5.21|-11.82|0.443
70889240|NCT01610700|141264524|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-6.85||||0.311|TWO_SIDED|95.0|-20.31|6.6|||ANCOVA|||The change in the tremor visual analogue scale score was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||6.60|-20.31|0.311
70889241|NCT01610700|141264525|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-6.26|STANDARD_ERROR_OF_MEAN|4.36||0.154|TWO_SIDED|95.0|-14.9|2.38|||ANCOVA|||The change in bladder problems visual analogue scale score was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||2.38|-14.90|0.154
70889242|NCT01610700|141264526|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.36||||0.293|TWO_SIDED|95.0|0.77|2.43|||Fisher Exact|||The proportion of subjects with better/much better assessments was compared between groups using a Fisher's Exact Test.||2.43|0.77|0.293
70889243|NCT01610700|141264528|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.69||||0.45|TWO_SIDED|95.0|-1.11|2.5|||ANCOVA|||The change from baseline in the mean Beck's Depression Inventory score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||2.50|-1.11|0.450
70889244|NCT01610700|141264529|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.12||||0.427|TWO_SIDED|95.0|-0.43|0.18|||ANCOVA|||The change baseline in the mean Fatigue Severity Scale Questionnaire score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||0.18|-0.43|0.427
70889245|NCT01610700|141264531|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.72||||0.647|TWO_SIDED|95.0|-2.38|3.82|||ANCOVA|||The change from baseline in the mean total 28-item General Health Questionnaire score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||3.82|-2.38|0.647
70889246|NCT01610700|141264533|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.12|STANDARD_ERROR_OF_MEAN|0.83||0.889|TWO_SIDED|95.0|-1.77|1.54|||ANCOVA|||The change from baseline in the mean total bladder control test score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||1.54|-1.77|0.889
70889247|NCT01610700|141264536|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-7.1||||0.047|TWO_SIDED|95.0|-14.11|-0.08|||ANCOVA|||The from baseline in the mean sleep quality 100 mm visual analogue scale score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||-0.08|-14.11|0.047
70889248|NCT01610700|141264537|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-4.53||||0.198|TWO_SIDED|95.0|-11.45|2.4|||ANCOVA|||The change from baseline in the mean sleep amount 100 mm visual analogue scale score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||2.40|-11.45|0.198
70889249|NCT01610700|141264538|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.36||||0.717|TWO_SIDED|95.0|-8.8|6.07|||ANCOVA|||The from baseline in the mean feeling upon wakening 100 mm visual analogue scale score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||6.07|-8.80|0.717
70889250|NCT01610700|141264539|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.47||||0.087|TWO_SIDED|95.0|-1.01|0.07|||ANCOVA|||The change from baseline in the mean Barthel Activities for Daily Living scale score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||0.07|-1.01|0.087
70889251|NCT01610700|141264543|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|1.81||||0.048|TWO_SIDED|95.0|0.02|3.6|||ANCOVA|||The change from baseline in the mean Guy's Neurological Disability Scale score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||3.60|0.02|0.048
70889252|NCT01610700|141264544|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.11||||0.904|TWO_SIDED|95.0|-1.85|1.64|||ANCOVA|||The change from baseline in the mean Atkinson Morley Information Processing Battery test score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||1.64|-1.85|0.904
70889253|NCT00672477|141264563|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||< 0.0001
70889254|NCT00672477|141264564|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||< 0.0001
70889255|NCT02348489|141264565|SUPERIORITY||Difference in response rate (%)|1.92||||0.482|TWO_SIDED|96.0|-3.67|7.5|||Cochran-Mantel-Haenszel|||The complete response rate was compared between the treatment groups using a Cochran Mantel-Haenszel (CMH) test at an alpha level of 0.04 stratified to adjust for stratification factors used at randomization: age (\<75 or \>=75), Eastern Cooperative Oncology Group (ECOG) performance status (0-1, 2-3), study center region (North American, Europe, Rest of World), and secondary AML (secondary to MDS or other antecedent hematologic disorder) or poor-risk cytogenetics (Yes, No/Unknown).||7.5|-3.67|0.482
70889256|NCT02348489|141264566|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.7328|TWO_SIDED|95.0|0.83|1.14|||Stratified log-rank|||Overall survival curves were estimated using Kaplan-Meier method and compared between the treatment groups using a 2-sided stratification log-rank test, stratified by the same factors used at randomization: age (\<75 or \>=75), Eastern Cooperative Oncology Group (ECOG) performance status (0-1, 2-3), study center region (North American, Europe, Rest of World), and secondary AML (secondary to MDS or other antecedent hematologic disorder) or poor-risk cytogenetics (Yes, No/Unknown).||1.14|0.83|0.7328
70889257|NCT01639001|141264574|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.402|||<|0.0001|TWO_SIDED|95.0|0.286|0.565||The study was to be considered positive if the 1-sided log-rank test for PFS, stratified for baseline stratification factors (ECOG PS, ethnicity, and brain metastases) was significant at the 0.02496level.|1 sided stratified log-rank||Based on the Cox Proportional hazards model stratified by ECOG PS, ethnicity, and brain metastases. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of crizotinib.|The study was designed to test the null hypothesis H0: λ=1.0 versus the alternative hypothesis HA: λ \< 1.0, where λ is the hazard ratio (HR; Crizotinib/Chemotherapy). Evaluation of 160 PFS events in the 2 arms using a 1-sided log-rank test at the 0.025 level of significance was required to detect a HR of 0.64 with 80% power.||0.565|0.286|<0.0001
70889258|NCT01639001|141264575|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|41.869|||<|0.0001|TWO_SIDED|95.0|30.34|53.398||If the PFS endpoint was significant, ORR was to be considered significant if 2-sided p-value from Pearson chi-square test was \<= 0.04992.|2-sided pearson chi-square test||Treatment difference in ORR (%)|The confidence interval for the treatment difference was based on normal distribution.||53.398|30.340|<0.0001
70889259|NCT01639001|141264576|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.056||||0.6172|TWO_SIDED|95.0|0.734|1.521||If the PFS and ORR endpoints were significant, OS was to be considered significant if 1-sided, log-rank test stratified for ECOG, ethnicity and metastases was \<= 0.02496.|1 sided stratified log-rank||Based on the Cox Proportional hazards model stratified by ECOG PS, ethnicity, and brain metastases. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of crizotinib.|||1.521|0.734|0.6172
70889260|NCT01639001|141264577|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|8.906||||0.1204|TWO_SIDED|95.0|-2.275|20.086|||2-sided pearson chi-square test||Treatment Difference in DCR Rate (%)|The confidence interval for the treatment difference was based on normal distribution.||20.086|-2.275|0.1204
70889261|NCT01639001|141264581|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.348|||<|0.0001|TWO_SIDED|95.0|0.246|0.493|||1 sided unstratified log-rank||Based on the Cox Proportional hazards model.|||0.493|0.246|<0.0001
70889262|NCT01639001|141264582|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.669||||0.127|TWO_SIDED|95.0|0.335|1.338|||1 sided unstratified log-rank||Based on the Cox Proportional hazards model.|||1.338|0.335|0.1270
70889263|NCT01639001|141264583|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.277|||<|0.0001|TWO_SIDED|95.0|0.186|0.412|||1 sided unstratified log-rank||Based on the Cox Proportional hazards model.|||0.412|0.186|<0.0001
70889264|NCT01639001|141264584|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.432|||<|0.0001|TWO_SIDED|95.0|0.307|0.61||2-sided Hochberg adjusted p-values|2 sided unstratified log rank||Based on the Cox Proportional hazards model.|||0.610|0.307|<0.0001
70889265|NCT01639001|141264585|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.451|||<|0.0001|TWO_SIDED|95.0|3.79|11.11|||Mixed Models Analysis|||Analysis presented for QLQ-C30 Global QoL. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||11.11|3.79|<0.0001
70889266|NCT01639001|141264585|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.613||||0.014|TWO_SIDED|95.0|0.73|6.49|||Mixed Models Analysis|||Analysis presented for QLQ-C30 cognitive functioning. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||6.49|0.73|0.0140
70889267|NCT01639001|141264585|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.652||||0.2427|TWO_SIDED|95.0|-1.12|4.42|||Mixed Models Analysis|||Analysis presented for QLQ-C30 emotional functioning. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||4.42|-1.12|0.2427
70889268|NCT01639001|141264585|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.7267|||<|0.0001|TWO_SIDED|95.0|4.15|9.3|||Mixed Models Analysis|||Analysis presented for QLQ-C30 physical functioning. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||9.30|4.15|<0.0001
70889269|NCT01639001|141264585|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.8109||||0.0003|TWO_SIDED|95.0|3.15|10.47|||Mixed Models Analysis|||Analysis presented for QLQ-C30 role functioning. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||10.47|3.15|0.0003
70889270|NCT01639001|141264585|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.594||||0.014|TWO_SIDED|95.0|1.13|10.06|||Mixed Models Analysis|||Analysis presented for QLQ-C30 social functioning. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||10.06|1.13|0.0140
70889271|NCT01639001|141264586|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.0432||||0.0016|TWO_SIDED|95.0|-9.79|-2.3|||Mixed Models Analysis|||Analysis presented for QLQ-C30 appetite loss. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-2.30|-9.79|0.0016
70889272|NCT01639001|141264586|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.5026||||0.0263|TWO_SIDED|95.0|0.53|8.47|||Mixed Models Analysis|||Analysis presented for QLQ-C30 constipation. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||8.47|0.53|0.0263
70889273|NCT01639001|141264586|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|15.8085|||<|0.0001|TWO_SIDED|95.0|12.94|18.68|||Mixed Models Analysis|||Analysis presented for QLQ-C30 diarrhea. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||18.68|12.94|<0.0001
70889274|NCT01639001|141264586|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.7449|||<|0.0001|TWO_SIDED|95.0|-11.3|-4.19|||Mixed Models Analysis|||Analysis presented for QLQ-C30 dyspnea. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-4.19|-11.30|<0.0001
70889275|NCT01639001|141264586|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.4915||||0.0001|TWO_SIDED|95.0|-9.82|-3.17|||Mixed Models Analysis|||Analysis presented for QLQ-C30 fatigue. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-3.17|-9.82|0.0001
70889276|NCT01639001|141264586|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-3.6165||||0.2099|TWO_SIDED|95.0|-9.27|2.04|||Mixed Models Analysis|||Analysis presented for QLQ-C30 financial difficulties. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||2.04|-9.27|0.2099
70889277|NCT01639001|141264586|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.7756||||0.0004|TWO_SIDED|95.0|-10.49|-3.06|||Mixed Models Analysis|||Analysis presented for QLQ-C30 insomnia. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-3.06|-10.49|0.0004
70889278|NCT01639001|141264586|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.519||||0.0902|TWO_SIDED|95.0|-5.43|0.4|||Mixed Models Analysis|||Analysis presented for QLQ-C30 nausea and vomiting. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||0.40|-5.43|0.0902
70889279|NCT01639001|141264586|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-8.4349|||<|0.0001|TWO_SIDED|95.0|-11.42|-5.45|||Mixed Models Analysis|||Analysis presented for QLQ-C30 pain. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-5.45|-11.42|<0.0001
70889280|NCT01639001|141264587|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.8547||||0.0039|TWO_SIDED|95.0|-8.15|-1.56|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 alopecia. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-1.56|-8.15|0.0039
70889281|NCT01639001|141264587|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.9957||||0.0004|TWO_SIDED|95.0|-10.85|-3.14|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 coughing. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-3.14|-10.85|0.0004
70889282|NCT01639001|141264587|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.5181||||0.7082|TWO_SIDED|95.0|-3.23|2.2|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 dysphagia. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||2.20|-3.23|0.7082
70889283|NCT01639001|141264587|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-8.6471|||<|0.0001|TWO_SIDED|95.0|-11.85|-5.44|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 dyspnoea. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-5.44|-11.85|<0.0001
70889284|NCT01639001|141264587|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.2504||||0.1284|TWO_SIDED|95.0|-2.86|0.36|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 haemoptysis. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||0.36|-2.86|0.1284
70889285|NCT01639001|141264587|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.2363||||0.0265|TWO_SIDED|95.0|-7.98|-0.49|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 pain in arm or shoulder. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-0.49|-7.98|0.0265
70889286|NCT01639001|141264587|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.2237||||0.0185|TWO_SIDED|95.0|-7.74|-0.71|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 pain in chest. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-0.71|-7.74|0.0185
70889287|NCT01639001|141264587|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.5901||||0.0075|TWO_SIDED|95.0|-7.95|-1.23|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 pain in other parts. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-1.23|-7.95|0.0075
70889288|NCT01639001|141264587|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.6732||||0.2848|TWO_SIDED|95.0|-4.74|1.39|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 peripheral neuropathy. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||1.39|-4.74|0.2848
70889289|NCT01639001|141264587|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.398||||0.0296|TWO_SIDED|95.0|-4.56|-0.24|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 sore mouth. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-0.24|-4.56|0.0296
70889290|NCT01639001|141264588|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.9136||||0.0123|TWO_SIDED|95.0|0.85|6.98|||Mixed Models Analysis|||From a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EQ-5D VAS subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||6.98|0.85|0.0123
70889291|NCT01639001|141264589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0425||||0.032|TWO_SIDED|95.0|0.0|0.08|||Mixed Models Analysis|||From a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EQ-5D Index score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||0.08|0.00|0.0320
70889292|NCT01639001|141264591|SUPERIORITY_OR_OTHER_LEGACY||Overall percent agreement|0.934|||||TWO_SIDED|95.0|0.914|0.949|||||95% CI for agreement rate is calculated by the Wilson (Score) Confidence Limit method with alpha=0.05|||0.949|0.914|
70889293|NCT01639001|141264591|SUPERIORITY_OR_OTHER_LEGACY||Kappa|0.847|||||TWO_SIDED|95.0|0.8065|0.8875|||||Kappa coefficient is a statistic which measures inter-rater agreement for qualitative (categorical) items.|||0.8875|0.8065|
70889294|NCT00274716|141264612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|1.6||0.157|TWO_SIDED|95.0|-5.3|0.9|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||0.9|-5.3|0.157
70889295|NCT00274716|141264612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|1.5||0.01|TWO_SIDED|95.0|-7.1|-1.0|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||-1.0|-7.1|0.010
70889296|NCT00274716|141264612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|1.6||0.042|TWO_SIDED|95.0|-6.4|-0.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||-0.1|-6.4|0.042
70889297|NCT00274716|141264612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|1.6||0.517|TWO_SIDED|95.0|-2.1|4.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||4.1|-2.1|0.517
70889298|NCT00274716|141264612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|1.6||0.602|TWO_SIDED|95.0|-3.9|2.3|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||2.3|-3.9|0.602
70889299|NCT00274716|141264613|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|2.4||0.046|TWO_SIDED|95.0|-9.7|-0.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||-0.1|-9.7|0.046
70889300|NCT00274716|141264613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|2.4||0.108|TWO_SIDED|95.0|-8.7|0.9|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||0.9|-8.7|0.108
70889301|NCT00274716|141264613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|2.5||0.099|TWO_SIDED|95.0|-9.0|0.8|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||0.8|-9.0|0.099
70889302|NCT00274716|141264613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|2.5||0.752|TWO_SIDED|95.0|-5.7|4.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||4.1|-5.7|0.752
70889303|NCT00274716|141264613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|2.5||0.941|TWO_SIDED|95.0|-4.7|5.0|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||5.0|-4.7|0.941
70889304|NCT00274716|141264614|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.2|-0.7|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline weight as a continuous variable||||-0.7|-2.2|<0.001
70889305|NCT00274716|141264614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.4||0.003|TWO_SIDED|95.0|-1.9|-0.4|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline weight as a continuous variable||||-0.4|-1.9|0.003
70889306|NCT00274716|141264614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.4|-1.0|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline weight as a continuous variable||||-1.0|-2.4|<0.001
70889307|NCT00274716|141264614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.4||0.462|TWO_SIDED|95.0|-0.5|1.0|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline weight as a continuous variable||||1.0|-0.5|0.462
70889308|NCT00274716|141264614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.4||0.118|TWO_SIDED|95.0|-0.2|1.3|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline weight as a continuous variable||||1.3|-0.2|0.118
70889309|NCT00274716|141264615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.9||0.059|TWO_SIDED|95.0|-3.7|0.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline waist as a continuous variable||||0.1|-3.7|0.059
70889310|NCT00274716|141264615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6|STANDARD_ERROR_OF_MEAN|1.0|<|0.001|TWO_SIDED|95.0|-5.5|-1.7|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline waist as a continuous variable||||-1.7|-5.5|<0.001
70889311|NCT00274716|141264615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.9||0.136|TWO_SIDED|95.0|-3.3|0.5|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline waist as a continuous variable||||0.5|-3.3|0.136
70889312|NCT00274716|141264615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.9||0.686|TWO_SIDED|95.0|-2.2|1.4|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline waist as a continuous variable||||1.4|-2.2|0.686
70889313|NCT00274716|141264615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|0.9||0.022|TWO_SIDED|95.0|-4.0|-0.3|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline waist as a continuous variable||||-0.3|-4.0|0.022
70889314|NCT00274716|141264616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.3|STANDARD_ERROR_OF_MEAN|4.3||0.005|TWO_SIDED|95.0|-20.8|-3.7|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline LDL-C as a continuous variable||||-3.7|-20.8|0.005
70889315|NCT00274716|141264616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1|STANDARD_ERROR_OF_MEAN|4.4||0.066|TWO_SIDED|95.0|-16.7|0.5|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline LDL-C as a continuous variable||||0.5|-16.7|0.066
70889316|NCT00274716|141264616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5|STANDARD_ERROR_OF_MEAN|4.5||0.319|TWO_SIDED|95.0|-13.4|4.4|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline LDL-C as a continuous variable||||4.4|-13.4|0.319
70889317|NCT00274716|141264616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.8|STANDARD_ERROR_OF_MEAN|4.4||0.077|TWO_SIDED|95.0|-16.4|0.8|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline LDL-C as a continuous variable||||0.8|-16.4|0.077
70889318|NCT00274716|141264616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6|STANDARD_ERROR_OF_MEAN|4.4||0.418|TWO_SIDED|95.0|-12.2|5.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline LDL-C as a continuous variable||||5.1|-12.2|0.418
70889319|NCT00274716|141264617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|STANDARD_ERROR_OF_MEAN|2.5||0.015|TWO_SIDED|95.0|-11.3|-1.2|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline HDL-C as a continuous variable||||-1.2|-11.3|0.015
70889320|NCT00274716|141264617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|2.6||0.124|TWO_SIDED|95.0|-9.2|1.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline HDL-C as a continuous variable||||1.1|-9.2|0.124
70889321|NCT00274716|141264617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|2.6||0.429|TWO_SIDED|95.0|-3.1|7.2|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline HDL-C as a continuous variable||||7.2|-3.1|0.429
70889322|NCT00274716|141264617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.3|STANDARD_ERROR_OF_MEAN|2.5||0.001|TWO_SIDED|95.0|-13.3|-3.4|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline HDL-C as a continuous variable||||-3.4|-13.3|0.001
70889323|NCT00274716|141264617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|2.5||0.018|TWO_SIDED|95.0|-11.1|-1.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline HDL-C as a continuous variable||||-1.1|-11.1|0.018
70889324|NCT00274716|141264618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9|STANDARD_ERROR_OF_MEAN|9.0||0.587|TWO_SIDED|95.0|-12.9|22.8|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline TG as a continuous variable||||22.8|-12.9|0.587
70889325|NCT00274716|141264618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|9.2||0.562|TWO_SIDED|95.0|-23.5|12.8|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline TG as a continuous variable||||12.8|-23.5|0.562
70889326|NCT00274716|141264618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|9.2||0.802|TWO_SIDED|95.0|-15.8|20.4|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline TG as a continuous variable||||20.4|-15.8|0.802
70889327|NCT00274716|141264618|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|9.0||0.772|TWO_SIDED|95.0|-15.2|20.5|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline TG as a continuous variable||||20.5|-15.2|0.772
70889328|NCT00274716|141264618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.6|STANDARD_ERROR_OF_MEAN|9.2||0.409|TWO_SIDED|95.0|-25.9|10.6|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline TG as a continuous variable||||10.6|-25.9|0.409
70889329|NCT01162005|141264623|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
70889330|NCT02057757|141264652|EQUIVALENCE|The equivalence margin is 1.25 Days.||||||0.5634|||||||Fay - Shaw|||||||0.5634
70889331|NCT02057757|141264653|SUPERIORITY|||||||0.645||||||The p-value for each time point was calculated; Day 3|Fay - Shaw|||||||0.645
70889332|NCT02057757|141264653|SUPERIORITY|||||||0.989||||||The p-value for each value was calculated (Day 7).|Fay-Shaw|||||||0.989
70889333|NCT02057757|141264653|SUPERIORITY|||||||0.809||||||Day 14|Fay-Shaw|||||||0.809
70889334|NCT02057757|141264653|SUPERIORITY|||||||0.671||||||Day 28|Fay-Shaw|||||||0.671
70889335|NCT02057757|141264655|SUPERIORITY|||||||0.4277||||||Cough|Fay - Shaw|||||||0.4277
70889336|NCT02057757|141264655|SUPERIORITY|||||||0.4022||||||Sore Throat|Fay-Shaw|||||||0.4022
70889337|NCT02057757|141264655|SUPERIORITY|||||||0.5957||||||Fatigue|Fay-Shaw|||||||0.5957
70889338|NCT02057757|141264655|SUPERIORITY|||||||0.0446||||||Nasal Discharge|Fay-Shaw|||||||0.0446
70889339|NCT02057757|141264655|SUPERIORITY|||||||0.8628||||||Difficulty Breathing|Fay-Shaw|||||||0.8628
70889340|NCT02057757|141264655|SUPERIORITY|||||||0.16||||||Headache|Fay-Shaw|||||||0.16
70889341|NCT02057757|141264655|SUPERIORITY|||||||0.1234||||||Muscle Pain|Fay-Shaw|||||||0.1234
70889342|NCT02057757|141264655|SUPERIORITY|||||||0.2155||||||Nausea|Fay-Shaw|||||||0.2155
70889343|NCT02057757|141264655|SUPERIORITY|||||||0.5176||||||Vomiting|Fay-Shaw|||||||0.5176
70889344|NCT02057757|141264655|SUPERIORITY|||||||0.6986||||||Diarrhea|Fay-Shaw|||||||0.6986
70889345|NCT02057757|141264656|SUPERIORITY|||||||0.985|||||||Fay - Shaw|||||||0.9850
70889346|NCT02057757|141264657|SUPERIORITY|||||||0.681||||||Any Time|Fay - Shaw|||||||0.681
70889347|NCT02057757|141264657|SUPERIORITY|||||||0.341||||||Day 0|Fay-Shaw|||||||0.341
70889348|NCT02057757|141264657|SUPERIORITY|||||||0.321||||||Day 3|Fay-Shaw|||||||0.321
70889349|NCT02057757|141264657|SUPERIORITY|||||||0.957||||||Day 7|Fay-Shaw|||||||0.957
70889350|NCT02057757|141264657|SUPERIORITY|||||||0.788||||||Day 14|Fay-Shaw|||||||0.788
70889351|NCT02057757|141264657|SUPERIORITY|||||||0.544||||||Day 28|Fay-Shaw|||||||0.544
70889352|NCT02057757|141264658|SUPERIORITY|||||||0.671||||||Any Time|Fay - Shaw|||||||0.671
70889353|NCT02057757|141264658|SUPERIORITY|||||||0.325||||||Day 0|Fay-Shaw|||||||0.325
70889354|NCT02057757|141264658|SUPERIORITY|||||||0.987||||||Day 3|Fay-Shaw|||||||0.987
70889355|NCT02057757|141264658|SUPERIORITY|||||||0.987||||||Day 7|Fay-Shaw|||||||0.987
70889356|NCT02057757|141264658|SUPERIORITY|||||||0.311||||||Day 14|Fay-Shaw|||||||0.311
70889357|NCT02057757|141264659|SUPERIORITY|||||||0.973||||||Any Time|Fay - Shaw|||||||0.973
70889358|NCT02057757|141264659|SUPERIORITY|||||||0.575||||||Day 0|Fay-Shaw|||||||0.575
70889359|NCT02057757|141264659|SUPERIORITY|||||||0.548||||||Day 3|Fay-Shaw|||||||0.548
70889360|NCT02057757|141264659|SUPERIORITY|||||||0.987||||||Day 7|Fay-Shaw|||||||0.987
70889361|NCT02057757|141264659|SUPERIORITY|||||||0.987||||||Day 14|Fay-Shaw|||||||0.987
70889362|NCT02057757|141264659|SUPERIORITY|||||||0.987||||||Day 28|Fay-Shaw|||||||0.987
70889363|NCT02057757|141264660|SUPERIORITY|||||||0.928||||||Pneumonia|Fay - Shaw|||||||0.928
70889364|NCT02057757|141264660|SUPERIORITY|||||||0.9669||||||ARDS|Fay-Shaw|||||||0.9669
70889365|NCT02057757|141264660|SUPERIORITY|||||||0.0832||||||Bronchitis|Fay-Shaw|||||||0.0832
70889366|NCT02057757|141264661|SUPERIORITY|||||||0.036||||||Adults (\>= 18 Years ) - Global Assessment: Have you felt as good as you did before you had the respiratory illness?|Fay - Shaw|||||||0.0360
70889367|NCT02057757|141264661|SUPERIORITY|||||||0.038||||||Adults (\>= 18 Years) - Global Assessment: Are you functioning as well as you were before you had the respiratory illness?|Fay-Shaw|||||||0.0380
70889368|NCT02057757|141264661|SUPERIORITY|||||||0.5035||||||Children (\< 18 Years) - Global Assessment: Have you/your child felt as good as you did before you had the respiratory illness?|Fay-Shaw|||||||0.5035
70889369|NCT02057757|141264661|SUPERIORITY|||||||0.9231||||||Children (\<18 Years) - Global Assessment: Are you/your child functioning as well as you/your child were before you/your child had the respiratory illness?|Fay-Shaw|||||||0.9231
70889370|NCT02057757|141264665|SUPERIORITY|||||||0.9785||||||No Detectable Virus on Day 3|Fay-Shaw|||||||0.9785
70889371|NCT00456092|141264702|SUPERIORITY||Odds Ratio (OR)|4.19||||0.002|TWO_SIDED|95.0|1.72|10.2||A p-value \< 0.025 (2-sided) is considered statistically significant, after adjusting for two treatment comparisons using the Bonferroni procedure.|Chi-squared, Corrected|||||10.20|1.72|0.002
70889372|NCT00456092|141264702|SUPERIORITY||Odds Ratio (OR)|5.77|||<|0.001|TWO_SIDED|95.0|2.4|13.88||A p-value \< 0.025 (2-sided) is considered statistically significant, after adjusting for two treatment comparisons using the Bonferroni procedure.|Chi-squared, Corrected|||||13.88|2.40|< 0.001
70889373|NCT00456092|141264705|SUPERIORITY||Odds Ratio (OR)|5.12||||0.056|TWO_SIDED|95.0|1.06|24.67|||Chi-squared, Corrected|||||24.67|1.06|0.056
70889374|NCT00456092|141264705|SUPERIORITY||Odds Ratio (OR)|6.95||||0.012|TWO_SIDED|95.0|1.49|32.35|||Chi-squared, Corrected|||||32.35|1.49|0.012
70889375|NCT00456092|141264706|SUPERIORITY||Odds Ratio (OR)|5.4||||0.204|TWO_SIDED|95.0|0.61|47.54|||Chi-squared, Corrected|||||47.54|0.61|0.204
70889376|NCT00456092|141264706|SUPERIORITY||Odds Ratio (OR)|4.12||||0.371|TWO_SIDED|95.0|0.45|37.88|||Chi-squared, Corrected|||||37.88|0.45|0.371
70889377|NCT00456092|141264707|SUPERIORITY||Odds Ratio (OR)|1.568||||0.264|TWO_SIDED|95.0|0.79|3.11|||Chi-squared, Corrected|||||3.11|0.79|0.264
70889378|NCT00456092|141264707|SUPERIORITY||Odds Ratio (OR)|1.98||||0.071|TWO_SIDED|95.0|1.0|3.91|||Chi-squared, Corrected|||||3.91|1.00|0.071
70889379|NCT00456092|141264708|SUPERIORITY||Odds Ratio (OR)|1.305||||0.549|TWO_SIDED|95.0|0.66|2.57|||Chi-squared, Corrected|||||2.57|0.66|0.549
70889380|NCT00456092|141264708|SUPERIORITY||Odds Ratio (OR)|1.033||||1|TWO_SIDED|95.0|0.53|2.03|||Chi-squared, Corrected|||||2.03|0.53|1.000
70889381|NCT00456092|141264709|SUPERIORITY||Odds Ratio (OR)|2.06||||0.083|TWO_SIDED|95.0|0.98|4.34|||Chi-squared, Corrected|||||4.34|0.98|0.083
70889382|NCT00456092|141264709|SUPERIORITY||Odds Ratio (OR)|1.63||||0.279|TWO_SIDED|95.0|0.77|3.44|||Chi-squared, Corrected|||||3.44|0.77|0.279
70889383|NCT00456092|141264710|SUPERIORITY||Odds Ratio (OR)|1.32||||0.548|TWO_SIDED|95.0|0.66|2.66|||Chi-squared, Corrected|||||2.66|0.66|0.548
70889384|NCT00456092|141264710|SUPERIORITY||Odds Ratio (OR)|1.04||||1|TWO_SIDED|95.0|0.52|2.11|||Chi-squared, Corrected|||||2.11|0.52|1.000
70889385|NCT00456092|141264713|SUPERIORITY||Treatment Difference|11.58||||0.136|TWO_SIDED||||||ANOVA|ANOVA model with treatment as the factor.|Treatment Difference = Apremilast 20 mg BID - Placebo|||||0.136
70889386|NCT00456092|141264713|SUPERIORITY||Treatment Difference|13.53||||0.08|TWO_SIDED||||||ANOVA|ANOVA model with treatment as the factor.|Treatment Difference = Apremilast 20 mg BID - Placebo|||||0.080
70889387|NCT00456092|141264714|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.65|TWO_SIDED|95.0|0.745|1.211|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.|||1.211|0.745|0.650
70889388|NCT00456092|141264714|SUPERIORITY||Hazard Ratio (HR)|1.265||||0.283|TWO_SIDED|95.0|0.791|2.024|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.|||2.024|0.791|0.283
70889389|NCT00456092|141264715|SUPERIORITY||Hazard Ratio (HR)|1.337||||0.253|TWO_SIDED|95.0|0.791|2.26|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.|||2.260|0.791|0.253
70889390|NCT00456092|141264715|SUPERIORITY||Hazard Ratio (HR)|3.023||||0.026|TWO_SIDED|95.0|1.059|8.63|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.|||8.630|1.059|0.026
70889391|NCT00456092|141264716|SUPERIORITY||Hazard Ratio (HR)|1.006||||0.984|TWO_SIDED|95.0|0.457|2.215|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.|||2.215|0.457|0.984
70889392|NCT00456092|141264716|SUPERIORITY||Hazard Ratio (HR)|0.872||||0.836|TWO_SIDED|95.0|0.158|4.797|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.|||4.797|0.158|0.836
70889393|NCT00456092|141264721|SUPERIORITY||Adjusted Mean Difference|1.4||||0.308|TWO_SIDED||||||ANOVA|ANOVA model including treatment group, methotrexate use, and baseline score.|Adjusted mean difference (Apremilast-Placebo) was based on the ANOVA model described above.|Mental Component||||0.308
70889394|NCT00456092|141264721|SUPERIORITY||Adjusted Mean Difference|4.1||||0.003|TWO_SIDED||||||ANOVA|ANOVA model including treatment group, methotrexate use, and baseline score.|Adjusted mean difference (Apremilast-Placebo) was based on the ANOVA model described above.|Mental Component||||0.003
70889395|NCT00456092|141264721|SUPERIORITY||Adjusted Mean Difference|1.6||||0.182|TWO_SIDED||||||ANOVA|ANOVA model including treatment group, methotrexate use, and baseline score.|Adjusted mean difference (Apremilast-Placebo) was based on the ANOVA model described above.|Physical Component||||0.182
70889396|NCT00456092|141264721|SUPERIORITY||Adjusted Mean Difference|2.7||||0.026|TWO_SIDED||||||ANOVA|ANOVA model including treatment group, methotrexate use, and baseline score.|Adjusted mean difference (Apremilast-Placebo) was based on the ANOVA model described above.|Physical Component||||0.026
70889397|NCT00456092|141264722|SUPERIORITY||Adjusted Mean Difference|-2.1||||0.016|TWO_SIDED||||||ANOVA|ANOVA model using treatment group, methotrexate use, and interaction of treatment group and methotrexate use as factors.|The adjusted mean difference (Apremilast-Placebo) is based on an ANOVA model described above.|||||0.016
70889398|NCT00456092|141264722|SUPERIORITY||Adjusted Mean Difference|-1.4||||0.105|TWO_SIDED||||||ANOVA|ANOVA model using treatment group, methotrexate use, and interaction of treatment group and methotrexate use as factors.|The adjusted mean difference (Apremilast-Placebo) is based on an ANOVA model described above.|||||0.105
70889399|NCT00456092|141264724|SUPERIORITY||Adjusted Mean Difference|3.3||||0.028|TWO_SIDED||||||ANOVA|ANOVA model with treatment, methotrexate use, and interaction of treatment group and methotrexate use as factors and baseline score as the covariate.|The adjusted mean difference (Apremilast-Placebo) is based on an ANOVA model described above.|||||0.028
70889400|NCT00456092|141264724|SUPERIORITY||Adjusted Mean Difference|4.3||||0.004|TWO_SIDED||||||ANOVA|ANOVA model with treatment, methotrexate use, and interaction of treatment group and methotrexate use as factors with baseline score as the covariate.|The adjusted mean difference (Apremilast-Placebo) is based on an ANOVA model described above.|||||0.004
70889401|NCT01168999|141264749|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Chi-squared|||||||<0.01
70889402|NCT01168999|141264750|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Chi-squared|||||||0.01
70889403|NCT01168999|141264751|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Repeated Measure ANOVA|||||||>0.05
70889404|NCT01168999|141264752|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Repeated Measure ANOVA|||||||>0.05
70889405|NCT01168999|141264753|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Repeated Measure ANOVA|||||||0.05
70889406|NCT01168999|141264754|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Repeated Measure ANOVA|||||||>0.05
70889407|NCT01276327|141264758|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|99.92|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|90.0|97.11|102.81|||Unscaled average Bioequivalence||Geometric standard error of mean was calculated.|||102.81|97.11|
70889408|NCT01276327|141264759|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|94.17|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|89.08|99.55|||Unscaled average Bioequivalence||Geometric Standard error of mean was calculated.|||99.55|89.08|
70889409|NCT01276327|141264760|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together.|Adjusted gMean Ratio (Test/Ref) (%)|79.99|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|74.65|85.72|||Scaled average bioequivalence (SABE)||Geometric Standard error of mean was calculated.|||85.72|74.65|
70889410|NCT01276327|141264761|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|97.31|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|90.0|88.9|106.51|||Scaled average bioequivalence (SABE)||Geometric standard error of mean was calculated.|||106.51|88.90|
70889411|NCT01276327|141264762|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|99.92|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|90.0|97.1|102.81|||Unscaled average bioequivalence||Geometric Standard error of mean was calculated.|||102.81|97.10|
70889412|NCT01276327|141264763|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|101.85|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|90.0|98.18|105.67|||Unscaled average bioequivalence||Geometric standard error of mean was calculated.|||105.67|98.18|
70889413|NCT01276327|141264764|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|80.79|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|75.6|86.34|||Scaled average bioequivalence (SABE)||Geometric standard error of mean was calculated.|||86.34|75.60|
70889414|NCT01047683|141264767|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-33.1|||<|0.0001|TWO_SIDED|95.0|-46.6|-21.5||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.01 for the primary endpoint.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|A standard deviation of 45% in the TG measurements and a significance level of P \< 0.01 required a sample size of 69 completed patients per treatment group to provide greater than or equal to 90% power to detect a difference of 30% between AMR101 and placebo in the percentage of change from baseline in the fasting TG levels.||-21.5|-46.6|<0.0001
70889415|NCT01047683|141264767|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-19.7||||0.0051|TWO_SIDED|95.0|-33.3|-5.6|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-5.6|-33.3|0.0051
70889416|NCT01047683|141264768|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-28.6||||0.0005|TWO_SIDED|95.0|-43.4|-13.9||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05 for secondary and exploratory endpoints.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-13.9|-43.4|0.0005
70889417|NCT01047683|141264768|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-15.3||||0.1152|TWO_SIDED|95.0|-30.3|-0.7|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-0.7|-30.3|0.1152
70889418|NCT01047683|141264769|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-13.6||||0.0006|TWO_SIDED|95.0|-20.2|-6.3||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-6.3|-20.2|0.0006
70889419|NCT01047683|141264769|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-5.1||||0.2367|TWO_SIDED|95.0|-12.3|2.2|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||2.2|-12.3|0.2367
70889420|NCT01047683|141264770|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-8.5||||0.0019|TWO_SIDED|95.0|-13.5|-3.2||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-3.2|-13.5|0.0019
70889421|NCT01047683|141264770|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-2.6||||0.2367|TWO_SIDED|95.0|-7.8|1.9|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||1.9|-7.8|0.2367
70889422|NCT01047683|141264771|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-2.3||||0.6768|TWO_SIDED|95.0|-12.9|8.1||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||8.1|-12.9|0.6768
70889423|NCT01047683|141264771|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|5.2||||0.3022|TWO_SIDED|95.0|-5.4|15.6|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||15.6|-5.4|0.3022
70889424|NCT01047683|141264772|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-17.7|||<|0.0001|TWO_SIDED|95.0|-25.0|-11.3||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-11.3|-25.0|<0.0001
70889425|NCT01047683|141264772|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-8.1||||0.0182|TWO_SIDED|95.0|-15.1|-1.4|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-1.4|-15.1|0.0182
70889426|NCT02708745|141264784|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||||||.29
70889427|NCT02708745|141264785|SUPERIORITY|||||||0.18|||||||Chi-squared|||||||0.18
70889428|NCT02708745|141264786|SUPERIORITY|||||||0.78||||||For the barrier 'not having enough time to discuss vaccine concerns', P=0.78. For the barrier 'not realizing until late in visit that parent had vaccine concerns', P=0.37. For the barrier 'not understanding parent specific vaccine concerns', P=0.66.|Chi-squared|||||||0.78
70889429|NCT02480621|141264787|SUPERIORITY||Mean Difference (Net)|1.74|||<|0.1|TWO_SIDED||||||t-test, 2 sided|||||||<0.10
70889430|NCT00983580|141264793|SUPERIORITY|||||||0.448|||||||Chi-squared|||||||0.448
70889431|NCT00983580|141264794|SUPERIORITY|||||||0.358|||||||Wilcoxon (Mann-Whitney)|||This statistical analysis compares the difference between the number of patients with No adenoma recurrence at 12 months with those with adenoma recurrence at 12 months.||||0.358
70889432|NCT00983580|141264796|SUPERIORITY|||||||0.513|||||||t-test, 2 sided|||||||0.513
70889433|NCT01971346|141264802|OTHER|||||||0.38||||||Type III TNF-alpha p-value=0.36. Type III IFN-alpha p-value=0.36. Interaction was not included in this model.|Regression, Linear|||A cumulative score reflecting change in PASI during the course of treatment was calculated and treated as a continuous response variable. Linear modeling was done to determine if change in PASI score was associated with the baseline TNF-alpha signal, baseline IFN-alpha signal and/or an interaction between these two signals.||||0.38
70889434|NCT01971346|141264803|OTHER|||||||0.03||||||Test of Hypotheses for Between subject effect of PASI profile p-value=0.03 Test of Hypotheses for Within subject effect of Time p-value=0.38 Test of Hypotheses for Within subject effect of Time\*PASI profile p-value=0.31|ANOVA|||The strength of the TNF-alpha cytokine signals will be treated as a response variable in a univariate repeated measure analysis of variance, with PASI response profile and time as covariates. Testing if TNF-alpha signals are significantly altered during the course of etanercept therapy and if such changes differ between subjects with different PASI response profiles.||||0.03
70889435|NCT01971346|141264804|OTHER|||||||0.34||||||Test of Hypotheses for Between subject effect of PASI profile p-value=0.34 Test of Hypotheses for Within subject effect of Time p-value=0.73 Test of Hypotheses for Within subject effect of Time\*PASI profile p-value=0.57|ANOVA|||The strength of the IFN-alpha cytokine signals will be treated as a response variable in a univariate repeated measure analysis of variance, with PASI response profile and time as covariates. Testing if IFN-alpha signals are significantly altered during the course of etanercept therapy and if such changes differ between subjects with different PASI response profiles.||||0.34
70889436|NCT01652716|141264806|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.1349||0.0072|TWO_SIDED|95.0|-0.63|-0.1|||Mixed model for repeated measure (MMRM)|Based on a repeated measures mixed model including fixed categorical effects of treatment||||-0.10|-0.63|0.0072
70889437|NCT01652716|141264807|SUPERIORITY_OR_OTHER|||||||0.2247|||||||Cochran-Mantel-Haenszel|||||||0.2247
70889438|NCT01652716|141264808|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.2|STANDARD_ERROR_OF_MEAN|5.841||0.1656|TWO_SIDED|95.0|-21.7|1.3||Adjusted|Cochran-Mantel-Haenszel|||||1.3|-21.7|0.1656
70889439|NCT01652716|141264809|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.4497||0.3744|TWO_SIDED|95.0|-0.48|1.28|||Cochran-Mantel-Haenszel|||||1.28|-0.48|0.3744
70889440|NCT01652716|141264810|SUPERIORITY_OR_OTHER||LS Mean Difference|26.74|STANDARD_ERROR_OF_MEAN|15.8957||0.0985|TWO_SIDED|95.0|-5.16|58.64|||Cochran-Mantel-Haenszel|||||58.64|-5.16|0.0985
70889441|NCT03735862|141264812|OTHER|Paired t-Test|||||<|0.001|||||||t-test, 1 sided|||Difference between baseline and follow-up||||<0.001
70889442|NCT03735862|141264813|SUPERIORITY||||||<|0.0001|||||||McNemar|||Difference between baseline and follow-up||||<0.0001
70889443|NCT00360334|141264819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.71|||<|0.001||95.0|2.62|8.46|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the primary outcome divided by the odds of a patient in the insulin glargine arm achieving the primary outcome||8.46|2.62|<0.001
70889444|NCT00360334|141264820|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.76|||<|0.001||95.0|3.11|10.64|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||10.64|3.11|<0.001
70889445|NCT00360334|141264821|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
70889446|NCT00360334|141264822|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.28||95.0|0.44|1.26|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||1.26|0.44|0.280
70889447|NCT00360334|141264823|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.191||95.0|0.42|1.19|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||1.19|0.42|0.191
70889448|NCT00360334|141264824|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43||||0.363||95.0|0.66|3.07|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||3.07|0.66|0.363
70889449|NCT00360334|141264826|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Model Repeated Measures|||||||<0.001
70889450|NCT00360334|141264827|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Model Repeated Measures|||||||<0.001
70889451|NCT00360334|141264828|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Model Repeated Measures|||||||<0.001
70889452|NCT00360334|141264829|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Model Repeated Measures|||||||<0.001
70889453|NCT00360334|141264830|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Repeated Measures|||||||<0.001
70889454|NCT00360334|141264831|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|27.91||||0.001||95.0|3.7|210.54|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||210.54|3.70|0.001
70889455|NCT00360334|141264833|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Mixed Model Repeated Measures|||||||0.014
70889456|NCT00360334|141264834|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Mixed Model Repeated Measures|||||||0.100
70889457|NCT00360334|141264835|SUPERIORITY_OR_OTHER|||||||0.125||95.0|||||ANCOVA|||||||0.125
70889458|NCT00360334|141264836|SUPERIORITY_OR_OTHER|||||||0.471||95.0|||||ANCOVA|||||||0.471
70889459|NCT00360334|141264837|SUPERIORITY_OR_OTHER|||||||0.601||95.0|||||ANCOVA|||||||0.601
70889460|NCT00360334|141264838|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||ANCOVA|||||||0.650
70889461|NCT00360334|141264839|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||ANCOVA|||||||0.017
70889462|NCT00360334|141264840|SUPERIORITY_OR_OTHER|||||||0.667||95.0|||||ANCOVA|||||||0.667
70889463|NCT00360334|141264841|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.675||||0.139||95.0|0.401|1.136|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||1.136|0.401|0.139
70889464|NCT00360334|141264842|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.317||||0.001||95.0|0.159|0.63|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||0.630|0.159|0.001
70889465|NCT00360334|141264843|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.797||||0.716||95.0|0.235|2.705|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||2.705|0.235|0.716
70889466|NCT00360334|141264844|SUPERIORITY_OR_OTHER|||||||0.113||95.0|||||ANCOVA on ranks|||||||0.113
70889467|NCT00360334|141264845|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA on ranks|||||||<0.001
70889468|NCT00360334|141264846|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||ANCOVA on ranks|||||||0.740
70889469|NCT00594256|141264847|SUPERIORITY_OR_OTHER||||||=|0.002||95.0|||||t-test, 2 sided|||Open label baseline final paired t test||||=0.002
70889470|NCT00594256|141264848|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||Open label baseline final paired t test||||0.02
70889471|NCT00594256|141264849|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||t-test, 2 sided|||Open label baseline final paired t test||||0.04
70889472|NCT00594256|141264850|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||t-test, 2 sided|||Open label baseline final paired t test||||0.8
70889473|NCT00594256|141264851|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 1 sided|||Open label baseline final paired t test||||<0.01
70889474|NCT04160260|141264852|EQUIVALENCE|Omadacycline 300 mg PO provided equivalent total exposure as measured by AUC relative to omadacycline 100 mg IV.|Geometric Mean Ratio|95.17|||||TWO_SIDED|90.0|84.2|107.5|||||A t-test on the natural log-transformed PK parameter AUC(0-48) was performed to obtain the Geometric Mean Ratio and its confidence interval.|Comparison was performed with the 100 mg intravenous (IV) omadacycline treatment group (data were obtained from 6 completed studies-NCT numbers not available). Using the Day 1 plasma concentration profile of the 100 mg IV QD dosing from these studies, a BID dosing on Day 1 and a QD dosing on Day 2 was simulated using the superposition principle. Log Geometric Mean (GM) AUC(0-48) of omadacycline for the 100 mg IV omadacycline group was as follows:Participants analyzed=63; GM (SD)=9.98 (0.2091).||107.5|84.2|
70889475|NCT04160260|141264853|EQUIVALENCE|Omadacycline 300 mg PO provided equivalent total exposure as measured by AUC relative to omadacycline 100 mg IV.|Geometric Mean Ratio|100.8|||||TWO_SIDED|90.0|88.0|115.5|||||A t-test on the natural log-transformed PK parameter AUC(0-24) was performed to obtain the Geometric Mean Ratio and its confidence interval.|Comparison was performed with the 100 mg IV omadacycline treatment group (data were obtained from 6 completed studies-NCT numbers not available). Using the Day 1 plasma concentration profile of the 100 mg IV QD dosing from these studies, a BID dosing on Day 1 and a QD dosing on Day 2 was simulated using the superposition principle. Log GM AUC(0-24) of omadacycline for the 100 mg IV omadacycline group was as follows:Participants analyzed=63; GM (SD)=9.26 (0.1985).||115.5|88.0|
70889476|NCT03837496|141264872|SUPERIORITY||Slope|-0.66||||0.504|TWO_SIDED|95.0|-2.59|1.27||a priori threshold p\<0.05|ANCOVA|Adjusted for distress and receipt of ovarian suppression.||Analysis comparing the change in monthly adherence to adjuvant endocrine therapy across the study period adjusting for distress and receipt of ovarian suppression.||1.27|-2.59|.504
70889477|NCT03837496|141264872|SUPERIORITY||Slope|-0.17||||0.225|TWO_SIDED|95.0|-0.44|-0.1||a priori threshold p\<0.05|ANCOVA|Adjusted for distress and receipt of ovarian suppression||Analysis comparing the change in weekly adherence rates to adjuvant endocrine therapy across the study period adjusting for distress and receipt of ovarian suppression.||-0.10|-0.44|.225
70889478|NCT03837496|141264873|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.63|TWO_SIDED|95.0|-0.4|0.66||a priori threshold p \< 0.05|ANCOVA|Adjusted for baseline values of criterion outcomes, distress and receipt of ovarian suppression||Analysis comparing the change in self-reported endocrine therapy adherence between groups on the MARS-5 scale from baseline to 12-weeks post-baseline adjusting for distress, receipt of ovarian suppression, and baseline values of criterion outcome.||0.66|-0.40|.630
70889479|NCT03837496|141264874|SUPERIORITY||Mean Difference (Final Values)|2.58||||0.186|TWO_SIDED|95.0|-1.27|6.44||a priori threshold p \< 0.05|ANCOVA|Adjusted for baseline values of criterion outcomes, distress and receipt of ovarian suppression||Analysis comparing the change in satisfaction with adjuvant endocrine therapy between groups on the CTSQ from baseline to 12 weeks post-baseline adjusting for distress, receipt of ovarian suppression, and baseline values of criterion outcome.||6.44|-1.27|.186
70889480|NCT03837496|141264875|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.562|TWO_SIDED|95.0|-3.49|1.91||a priori threshold p \< 0.05|ANCOVA|Adjusted for baseline values of criterion outcomes, distress and receipt of ovarian suppression||Analysis comparing the change in symptom distress between groups on the BCPT scale from baseline to 12-weeks post-baseline adjusting for distress, receipt of ovarian suppression, and baseline values of criterion outcome.||1.91|-3.49|.562
70889481|NCT04551105|141264908|SUPERIORITY||different in area under the LROC curve|0.0374|||<|0.05|TWO_SIDED|95.0|0.019|0.0557|||OR-DBM model|||||0.0557|0.0190|<0.05
70889482|NCT04551105|141264909|SUPERIORITY||Mean Difference (Net)|12.78|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
70889483|NCT04551105|141264910|SUPERIORITY||different in sensitivity|-0.0013|||<|0.05|TWO_SIDED|95.0|-0.2307|0.2281|||McNemar|||||0.2281|-0.2307|<0.05
70889484|NCT04551105|141264910|SUPERIORITY||different in specificity|0.1065|||<|0.05|TWO_SIDED|95.0|0.0008|0.2122|||McNemar|||||0.2122|0.0008|<0.05
70889485|NCT04551105|141264910|SUPERIORITY||different in PPV|-0.086|||<|0.05|TWO_SIDED|95.0|-0.1824|0.0104|||McNemar|||||0.0104|-0.1824|<0.05
70889486|NCT04551105|141264910|SUPERIORITY||different in NPV|0.086|||<|0.05|TWO_SIDED|95.0|-0.0104|0.1824|||McNemar|||||0.1824|-0.0104|<0.05
70889487|NCT02447991|141264911|SUPERIORITY||||||<|0.33||||||Significance level p \< 0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of vertigo as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication.||||<0.33
70889488|NCT02447991|141264912|SUPERIORITY||||||<|0.18||||||Signficant at p \< 0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of unsteadiness/dizziness as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication||||<0.18
70889489|NCT02447991|141264913|SUPERIORITY||||||<|0.62||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of vertigo as measured by the proportion of treated episodes in which subjects experience freedom from vestibular symptoms (i.e., severity rating of Grade 0) at 1 hour after taking study medication.||||<0.62
70889490|NCT02447991|141264914|SUPERIORITY||||||<|0.19||||||Significance threshold p \< 0.05|Chi-squared, Corrected|This analysis applies to proportions of treated episodes||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of unsteadiness/dizziness as measured by the proportion of treated episodes in which subjects experience freedom from vestibular symptoms (i.e., severity rating of Grade 0) at 1 hour after taking study medication.||||<0.19
70889491|NCT02447991|141264915|SUPERIORITY||||||<|0.14||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of headaches as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication.||||<0.14
70889492|NCT02447991|141264916|SUPERIORITY||||||<|0.72||||||Significance threshold p \< 0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of photophobia/phonophobia as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication.||||<0.72
70889493|NCT02447991|141264917|SUPERIORITY||||||<|0.48||||||Significance threshold p \< 0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of sensitivity to motion as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication.||||<0.48
70889494|NCT02447991|141264918|SUPERIORITY||||||<|0.35||||||Significance threshold p \< 0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of nausea/vomiting as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication..||||<0.35
70889495|NCT02447991|141264919|SUPERIORITY||||||<|0.022||||||Significance of threshold p\<0.05|Regression, Linear|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo on the Treatment Satisfaction Questionnaire for Medication at 48 hours after each attack treated with effectiveness of study medication||||<0.022
70889496|NCT02447991|141264919|SUPERIORITY||||||<|0.418||||||Significance of threshold p\<0.05|Regression, Linear|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo on the Treatment Satisfaction Questionnaire for Medication at 48 hours after each attack treated with side effects of study medication||||<0.418
70889497|NCT02447991|141264919|SUPERIORITY||||||<|0.674||||||Significance of threshold p\<0.05|Regression, Linear|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo on the Treatment Satisfaction Questionnaire for Medication at 48 hours after each attack treated with convenience of study medication||||<0.674
70889498|NCT02447991|141264919|SUPERIORITY||||||<|0.016||||||Significance of threshold of p\<0.05|Regression, Linear|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo on the Treatment Satisfaction Questionnaire for Medication at 48 hours after each attack treated with overall satisfaction of study medication||||<0.016
70889499|NCT02447991|141264920|SUPERIORITY||||||<|0.009||||||Significance threshold p\<0.05|Regression, Linear|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo on physical well-being||||<0.009
70889500|NCT02447991|141264920|SUPERIORITY||||||<|0.467||||||Significance threshold p\<0.05|Regression, Linear|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo on mental well-being||||<0.467
70889501|NCT02447991|141264921|SUPERIORITY||||||<|0.013||||||Significance threshold p\<0.05|Logistic regression with GEE|GEE=generalized estimating equations - this accounts for repeated measures within patients.This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be tolerated as well as placebo with regard to fatigue.||||<0.013
70889502|NCT02447991|141264921|SUPERIORITY||||||<|0.021||||||Significance threshold p\<0.05|Logistic regression with GEE|GEE=generalized estimating equations - this accounts for repeated measures within patients. This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be tolerated as well as placebo with regard to sleepiness/drowsiness||||<0.021
70889503|NCT02447991|141264922|SUPERIORITY||||||<|0.76||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of vertigo measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.||||<0.76
70889504|NCT02447991|141264923|SUPERIORITY||||||<|0.041||||||Significance threshold p \< 0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of unsteadiness/dizziness episodes measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.||||<0.041
70889505|NCT02447991|141264924|SUPERIORITY||||||<|0.12||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of headaches measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.||||<0.12
70889506|NCT02447991|141264925|SUPERIORITY||||||<|0.051||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of photophobia/phonophobia measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.||||<0.051
70889507|NCT02447991|141264926|SUPERIORITY||||||<|0.006||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of sensitivity to motion measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.||||<0.006
70889508|NCT02447991|141264927|SUPERIORITY||||||<|0.67||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of nausea/vomiting measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.||||<0.67
70889509|NCT00459134|141264928|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|1.19||0.576|TWO_SIDED|95.0|-1.67|3.0||This p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|Mixed effect repeated measures model constrained such that the baseline means were equal in the two groups.||The null hypothesis is that sexual function will be the same in both groups at 12 weeks. A Mixed effect repeated measures model constrained such that the baseline means were equal in the two groups was used to test this hypothesis.||3.00|-1.67|0.576
70889510|NCT00459134|141264929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.49|STANDARD_ERROR_OF_MEAN|1.73||0.01|TWO_SIDED|95.0|1.09|7.89||This p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|Mixed effect repeated measures model constrained such that the baseline means were equal in the two groups.||The null hypothesis was that quality of life would be the same in both groups at 12 weeks. A mixed effect repeated measures model constrained such that the baseline means were equal in the two groups was used to test this hypothesis.||7.89|1.09|0.010
70889511|NCT01612546|141264938|OTHER||||||<|0.01|||||||Fisher Exact|||||||<0.01
70889512|NCT01016834|141264948|SUPERIORITY_OR_OTHER|||||||0.0007|||||||t-test, 2 sided|||For the primary analyses and other PPMQ-R variables, the mean of the differences between each subject's rating of overall treatment satisfaction at the end of study based on the subject's experience using Sumavel DosePro and the rating at baseline based on the subject's pre-study triptan treatment were compared using a two-sided paired t-test at the 5% level of significance||||0.0007
70889513|NCT03328897|141264984|SUPERIORITY||Mean Difference (Net)|-4.23|STANDARD_ERROR_OF_MEAN|0.746|<|0.001|TWO_SIDED|95.0|-5.7|-2.77|||Mixed Model with Repeated Measures(MMRM)|||||-2.77|-5.70|<0.001
70889514|NCT03328897|141264984|SUPERIORITY||Mean Difference (Net)|-3.79|STANDARD_ERROR_OF_MEAN|0.738|<|0.001|TWO_SIDED|95.0|-5.24|-2.33|||Mixed Model with Repeated Measures(MMRM)|||||-2.33|-5.24|<0.001
70889515|NCT03328897|141264985|SUPERIORITY||Mean Difference (Net)|-10.19|STANDARD_ERROR_OF_MEAN|1.555|<|0.001|TWO_SIDED|95.0|-13.25|-7.14|||Mixed Model with Repeated Measures(MMRM)|||||-7.14|-13.25|<0.001
70889516|NCT03328897|141264985|SUPERIORITY||Mean Difference (Net)|-9.12|STANDARD_ERROR_OF_MEAN|1.535|<|0.001|TWO_SIDED|95.0|-12.14|-6.1|||Mixed Model with Repeated Measures(MMRM)|||||-6.10|-12.14|<0.001
70889517|NCT03328897|141264986|SUPERIORITY||Mean Difference (Net)|-5.92|STANDARD_ERROR_OF_MEAN|0.853|<|0.001|TWO_SIDED|95.0|-7.59|-4.24|||Mixed Model with Repeated Measures(MMRM)|||||-4.24|-7.59|<0.001
70889518|NCT03328897|141264986|SUPERIORITY||Mean Difference (Net)|-5.35|STANDARD_ERROR_OF_MEAN|0.842|<|0.001|TWO_SIDED|95.0|-7.0|-3.69|||Mixed Model with Repeated Measures(MMRM)|||||-3.69|-7.00|<0.001
70889519|NCT03328897|141264987|SUPERIORITY||Odds Ratio (OR)|7.02|||<|0.001|TWO_SIDED|95.0|3.27|15.06|||Regression, Logistic|||||15.06|3.27|<0.001
70889520|NCT03328897|141264987|SUPERIORITY||Odds Ratio (OR)|7.03|||<|0.001|TWO_SIDED|95.0|3.29|15.06|||Regression, Logistic|||||15.06|3.29|<0.001
70889521|NCT03328897|141264988|SUPERIORITY||Odds Ratio (OR)|11.21|||<|0.001|TWO_SIDED|95.0|3.88|32.37|||Regression, Logistic|||||32.37|3.88|<0.001
70889522|NCT03328897|141264988|SUPERIORITY||Odds Ratio (OR)|5.88||||0.001|TWO_SIDED|95.0|2.01|17.17|||Regression, Logistic|||||17.17|2.01|0.001
70889523|NCT03328897|141264989|SUPERIORITY||Odds Ratio (OR)|2.73|||<|0.001|TWO_SIDED|95.0|1.51|4.95|||Regression, Logistic|||||4.95|1.51|<0.001
70889524|NCT03328897|141264989|SUPERIORITY||Odds Ratio (OR)|2.53||||0.002|TWO_SIDED|95.0|1.41|4.56|||Regression, Logistic|||||4.56|1.41|0.002
70889525|NCT03328897|141264990|SUPERIORITY||Mean Difference (Net)|-4.0|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|95.0|-5.7|-2.3|||Mixed Model with Repeated Measures(MMRM)|||||-2.3|-5.7|<0.001
70889526|NCT03328897|141264990|SUPERIORITY||Mean Difference (Net)|-3.5|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|95.0|-5.1|-1.8|||Mixed Model with Repeated Measures(MMRM)|||||-1.8|-5.1|<0.001
70889527|NCT03328897|141264991|SUPERIORITY||Hazard Ratio (HR)|1.71|||<|0.001|TWO_SIDED|95.0|1.25|2.33|||Regression, Cox|||||2.33|1.25|<0.001
70889528|NCT03328897|141264991|SUPERIORITY||Hazard Ratio (HR)|1.66||||0.001|TWO_SIDED|95.0|1.22|2.25|||Regression, Cox|||||2.25|1.22|0.001
70889529|NCT01969838|141265010|NON_INFERIORITY|To evaluate the noninferiority of MMB over RUX, a conventional 2-sided confidence interval (CI) was calculated for the difference in splenic response rate (SRR) at Week 24: delta = prob(MMB) - 0.6\*prob(RUX). If the lower bound of the 2-sided 95% CI for delta was greater than 0, MMB was declared noninferior to RUX in SRR at Week 24. The 2-sided 95% CI of delta was calculated based on stratum-adjusted Cochran-Mantel-Haenszel (CMH) proportions. This is the noninferiority proportion difference.|Proportion Difference - Stratified CMH|0.09||||0.014|TWO_SIDED|95.0|0.02|0.16|||Cochran-Mantel-Haenszel|||||0.16|0.02|0.014
70889530|NCT01969838|141265011|NON_INFERIORITY|To evaluate the noninferiority of MMB over RUX, a conventional 2-sided CI was calculated for the difference in TSS response rate at Week 24: delta = prob(MMB) - 0.67\*prob(RUX). If the lower bound of the 2-sided 95% CI for delta was greater than 0, MMB was declared to be noninferior to RUX in TSS response rate at Week 24. The 2-sided 95% CI of delta was calculated based on stratum-adjusted Cochran-Mantel-Haenszel (CMH) proportions. This is called the noninferiority proportion difference.|Proportion Difference - Stratified CMH|0.0||||0.98|TWO_SIDED|95.0|-0.08|0.08|||Cochran-Mantel-Haenszel|||||0.08|-0.08|0.98
70889531|NCT01969838|141265012|SUPERIORITY||Rate ratio|0.28|||<|0.001|TWO_SIDED|95.0|0.19|0.43|||Negative Binomial Model, Adjusted||A smaller ratio represents larger benefit.|||0.43|0.19|<0.001
70889532|NCT01969838|141265013|SUPERIORITY||Proportion Difference - Stratified CMH|0.18|||<|0.001|TWO_SIDED|95.0|0.09|0.26|||Cochran-Mantel-Haenszel||A larger proportion represents larger benefit.|||0.26|0.09|<0.001
70889533|NCT01969838|141265014|SUPERIORITY||Proportion Difference - Stratified CMH|-0.1||||0.019|TWO_SIDED|95.0|-0.19|-0.02|||Cochran-Mantel-Haenszel||A smaller proportion represents larger benefit.|||-0.02|-0.19|0.019
70889534|NCT00408993|141265022|SUPERIORITY_OR_OTHER|||||||0.617||95.0||||Treatment effects were evaluated based on a two-sided significance level of 0.05 and interaction effects at 0.10. No adjustments for multiple comparisons were made.|ANCOVA|Model=Treatment, Pooled Investigator and Baseline.||With 104 patients per arm, the study has at least 85% power to detect a treatment group difference of -1.20 points in baseline to endpoint mean change on the BPI 24-hour average pain score between Duloxetine and Placebo. Sample size determined using a two-sided t-test with alpha=0.05, and assuming a common standard deviation of 2.5 and a discontinuation rate of 25%.||||0.617
70889535|NCT00408993|141265023|SUPERIORITY_OR_OTHER|||||||0.07||95.0||||P-value for Worst Pain Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.070
70889536|NCT00408993|141265023|SUPERIORITY_OR_OTHER|||||||0.151||95.0||||P-value for Least Pain Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.151
70889537|NCT00408993|141265023|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-value for Pain Right Now Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.012
70889538|NCT00408993|141265023|SUPERIORITY_OR_OTHER|||||||0.077||95.0||||P-value for Average Interference Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.077
70889539|NCT00408993|141265024|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.036
70889540|NCT00408993|141265025|SUPERIORITY_OR_OTHER|||||||0.955||95.0||||P-value for Visit 3|Mixed Models Analysis|Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment\*Visit and Baseline\*Visit.||||||0.955
70889541|NCT00408993|141265025|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value for Visit 4|Mixed Models Analysis|Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment\*Visit and Baseline\*Visit.||||||0.004
70889542|NCT00408993|141265025|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||P-value for Visit 5|Mixed Models Analysis|Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment\*Visit and Baseline\*Visit.||||||0.037
70889543|NCT00408993|141265025|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Visit 6|Mixed Models Analysis|Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment\*Visit and Baseline\*Visit.||||||<0.001
70889544|NCT00408993|141265025|SUPERIORITY_OR_OTHER|||||||0.028||95.0||||P-value for Visit 7|Mixed Models Analysis|Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment\*Visit and Baseline\*Visit.||||||0.028
70889545|NCT00408993|141265026|SUPERIORITY_OR_OTHER|||||||0.207||95.0|||||ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.207
70889546|NCT00408993|141265027|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Fisher Exact|||||||0.008
70889547|NCT00408993|141265029|SUPERIORITY_OR_OTHER|||||||0.364||95.0||||P-value for 5-Item Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.364
70889548|NCT00408993|141265029|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||P-value for 8-Item Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.590
70889549|NCT00408993|141265030|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||ANOVA|Model=Treatment and Pooled Investigator||||||0.620
70889550|NCT00408993|141265031|SUPERIORITY_OR_OTHER|||||||0.324||95.0|||||ANOVA|Model=Treatment and Pooled Investigator||||||0.324
70889551|NCT00408993|141265032|SUPERIORITY_OR_OTHER|||||||0.642||95.0||||P-value for Systolic Blood Pressure|ANOVA|Model=Treatment and Pooled Investigator||||||0.642
70889552|NCT00408993|141265032|SUPERIORITY_OR_OTHER|||||||0.601||95.0||||P-value for Diastolic Blood Pressure|ANOVA|Model=Treatment and Pooled Investigator||||||0.601
70889553|NCT00408993|141265033|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||P-value for Chloride|ANOVA|Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-value.||||||0.014
70889554|NCT00408993|141265033|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for High Density Lipoprotein Cholesterol|ANOVA|Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-value.||||||0.005
70889555|NCT00408993|141265033|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for Sodium|ANOVA|Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-value.||||||0.011
70889556|NCT00408993|141265033|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||P-value for triglycerides|ANOVA|Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-value.||||||0.044
70889557|NCT00408993|141265034|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||ANOVA|Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-values.||||||0.017
70889558|NCT01694706|141265047|NON_INFERIORITY_OR_EQUIVALENCE|no formal testing, investigation of bioavailability|Geometric Mean Ratio|120.35|STANDARD_DEVIATION|23.2||0.342|TWO_SIDED|90.0|102.09|141.88|||ANOVA|Ratio calculated as Faldaprevir after a high-fat meal divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)|||141.88|102.09|0.3420
70889559|NCT01694706|141265047|NON_INFERIORITY_OR_EQUIVALENCE|no formal testing, investigation of bioavailability|Geometric Mean Ratio|94.33|STANDARD_DEVIATION|30.8||0.0962|TWO_SIDED|90.0|76.21|116.76|||ANOVA|Ratio calculated as Faldaprevir and Omeprazole divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)|||116.76|76.21|0.0962
70889560|NCT01694706|141265048|NON_INFERIORITY_OR_EQUIVALENCE|no formal testing, investigation of bioavailability|Geometric Mean Ratio|118.79|STANDARD_DEVIATION|52.4||0.3993|TWO_SIDED|90.0|83.19|169.628|||ANOVA|Ratio calculated as Faldaprevir after a high-fat meal divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)|||169.628|83.190|0.3993
70889561|NCT01694706|141265048|NON_INFERIORITY_OR_EQUIVALENCE|no formal testing, investigation of bioavailability|Geometric Mean Ratio|93.55|STANDARD_DEVIATION|53.0||0.2204|TWO_SIDED|90.0|65.783|133.03|||ANOVA|Ratio calculated as Faldaprevir and Omeprazole divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)|||133.030|65.783|0.2204
70889562|NCT01694706|141265049|NON_INFERIORITY_OR_EQUIVALENCE|no formal testing, investigation of bioavailability|Geometric Mean Ratio|121.28|STANDARD_DEVIATION|24.0||0.3765|TWO_SIDED|90.0|102.32|143.74|||ANOVA|Ratio calculated as Faldaprevir after a high-fat meal divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)|||143.74|102.32|0.3765
70889563|NCT01694706|141265049|NON_INFERIORITY_OR_EQUIVALENCE|no formal testing, investigation of bioavailability|Geometric Mean Ratio|94.72|STANDARD_DEVIATION|31.4||0.0946|TWO_SIDED|90.0|76.25|117.67|||ANOVA|Ratio calculated as Faldaprevir and Omeprazole divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)|||117.67|76.25|0.0946
70889564|NCT03779997|141265050|SUPERIORITY||Risk Ratio (RR)|0.78|STANDARD_DEVIATION|0.1||0.07|TWO_SIDED|95.0|0.6|1.02||0.05 a priori threshold for statistical significance.|Log-linear GEE regression|||Null hypothesis: no difference in the percentage of urine drug tests (UDT) negative for opioids between the two treatment arms.Treatment-as-usual (TAU) is the reference group.||1.02|0.60|0.07
70889565|NCT03779997|141265051|SUPERIORITY||Risk Ratio (RR)|0.84|STANDARD_DEVIATION|0.11||0.2|TWO_SIDED|95.0|0.65|1.1||0.05 a priori threshold for statistical significance.|Poisson regression with robust SEs|||Null hypothesis: no difference between treatment arms in the percentage of patients engaged in treatment at week 12. TAU is the reference group.||1.10|0.65|0.20
70889566|NCT03779997|141265052|SUPERIORITY||Risk Ratio (RR)|0.73|STANDARD_DEVIATION|0.17||0.18|TWO_SIDED|95.0|0.45|1.16||0.05 a priori threshold for statistical significance.|Poisson regression with robust SEs|||Null hypothesis: No difference between arms in the percentage of participants engaged in treatment at week 24 post-randomization. TAU is the reference group.||1.16|0.45|0.18
70889567|NCT03779997|141265053|SUPERIORITY||Median Difference (Final Values)|0.9|STANDARD_DEVIATION|0.45||0.31|TWO_SIDED|95.0|-0.9|2.7||0.05 a priori threshold for statistical significance.|t-test, 2 sided||TAU is the reference group.|Null hypothesis: No difference between arms on the number of consecutive weeks with UDT negative for opioids.||2.7|-0.9|0.31
70889568|NCT03779997|141265054|SUPERIORITY||Risk Ratio (RR)|0.71|STANDARD_DEVIATION|0.41||0.57|TWO_SIDED|95.0|0.23|2.26||0.05 a priori threshold for statistical significance.|Poisson regression with robust SEs||TAU is the reference group.|Null hypothesis: No difference between arms in the number of participants who self-reported illicit opioid use at week 12.||2.26|0.23|0.57
70889569|NCT03779997|141265055|SUPERIORITY||Risk Ratio (RR)|1.01|STANDARD_DEVIATION|0.066||0.88|TWO_SIDED|95.0|0.89|1.15||0.05 a priori threshold for statistical significance.|GEE Poisson regression||TAU is the reference group.|Null hypothesis: No difference between arms in the mean number of days adherent to buprenorphine by self-report.||1.15|0.89|0.88
70889570|NCT03779997|141265057|SUPERIORITY||Risk Ratio (RR)|1.17|STANDARD_DEVIATION|0.6||0.77|TWO_SIDED|95.0|0.42|3.24||0.05 a priori threshold for statistical significance.|Poisson regression with robust SEs||TAU is the reference group.|Null hypothesis: No difference between arms in number of participants who had one or more urine drug tests negative for buprenorphine.||3.24|0.42|0.77
70889571|NCT03779997|141265058|SUPERIORITY||Risk Ratio (RR)|0.67|STANDARD_DEVIATION|0.26||0.3|TWO_SIDED|95.0|0.32|1.43||0.05 a priori threshold for statistical significance.|Poisson regression with robust SEs||TAU is the reference group.|Null hypothesis: No difference between arms in number of participants who tested positive for stimulants at week 12.||1.43|0.32|0.30
70889572|NCT03779997|141265059|SUPERIORITY||Median Difference (Final Values)|0.02|STANDARD_DEVIATION|0.07||0.91|TWO_SIDED|95.0|-0.29|0.32||0.05 a priori threshold for statistical significance|t-test, 2 sided||TAU is the reference group|Null hypothesis: No difference between arms in mean treatment satisfaction scores||0.32|-0.29|0.91
70889573|NCT00491244|141265064|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.8|||<|0.001|TWO_SIDED|95.0|1.46|2.21|||Chi-squared|||||2.21|1.46|< 0.001
70889574|NCT00491244|141265065|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.61||||0.35|TWO_SIDED|95.0|0.65|4.01|||Chi-squared|||||4.01|0.65|0.35
70889575|NCT03264157|141265073|NON_INFERIORITY|The null hypothesis is p-p0 ≤ -0.1. The alternative hypothesis is p-p0 \> -0.1, where p is the proportion of subjects with anti-rabies titer of \>0.5 IU/mL at Day 14 in subjects receiving BPL HRIG + vaccine and p0 is the proportion receiving comparator HRIG + vaccine. We reject the null hypothesis at the one-sided 0.025 significance level, and conclude that p-p0 \> -0.1, if the lower bound of an exact 95% binomial confidence interval exceeds -0.1.|lower 95% CI|-0.05||||0.0006|ONE_SIDED|95.0|-0.05|||The threshold for this test is \<=0.025.|Farrington and Manning test||||||-0.05|0.0006
70889576|NCT03264157|141265074|NON_INFERIORITY|The prespecified non inferiority margin was 20%. The lower bound of the 95% CI required should be greater than 0.8 to conclude non-inferiority.|lower 95% CI|0.74|||||TWO_SIDED|95.0|0.74|0.94||||||||0.94|0.74|
70889577|NCT03264157|141265075|SUPERIORITY||95% CI|0.97|||||TWO_SIDED||||||||Data analyzed as log normal. The value presented is the untransformed value of the difference between means.|||||
70889578|NCT03264157|141265076|NON_INFERIORITY|The same methodology was used as the primary endpoint for each visit. The statistical analysis is presenting the Day 14 data.|lower 95% CI|-0.05||||0.0006|TWO_SIDED|95.0|-0.05|0.1|||Farrington and Manning test|||||0.10|-0.05|0.0006
70889579|NCT03264157|141265077|NON_INFERIORITY|The same methodology was used as the primary endpoint for each visit. The statistical analysis is presenting the Day 14 data.|lower 95% CI|0.0||||0|TWO_SIDED|95.0|0.0|0.0|||Farrington and Manning test||For Day 14, all subjects achieved the endpoint (RVNA titer \> LLOQ). Since the statistic to measure the performance is a proportion, the proportion is 1 and no variance is calculable.|||0|0|0
70889580|NCT00659269|141265092|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED||||||ANOVA|||||||0.91
70889581|NCT01260922|141265126|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.16|||||TWO_SIDED|90.0|97.07|107.51|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||107.51|97.07|
70889582|NCT01260922|141265127|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Slope|94.75|||||TWO_SIDED|90.0|92.11|97.46|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||97.46|92.11|
70889583|NCT04165291|141265129|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<.01
70889584|NCT04165291|141265130|OTHER|||||||0.08|||||||ANOVA|||||||.08
70889585|NCT04165291|141265131|SUPERIORITY|||||||0.116|||||||Repeated Measures Analysis of Variance|||||||.116
70889586|NCT04165291|141265132|SUPERIORITY||Mean Difference (Final Values)|5.146|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<.05
70889587|NCT04165291|141265133|SUPERIORITY|||||||0.13|||||||ANOVA|||||||.13
70889588|NCT04165291|141265134|SUPERIORITY|||||||0.35|||||||ANOVA|||||||.35
70889589|NCT01385059|141265146|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
70889590|NCT01767116|141265147|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus placebo RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 73% to achieve noninferiority.|Percentage of Participants|100.0|||||TWO_SIDED|95.0|98.2|100.0|||||95% CI was calculated using the Wilson score method for the single proportion because the point estimate was 100%..|For the primary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per treatment arm provides \>95% power to demonstrate noninferiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (84%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|98.2|
70889591|NCT01767116|141265147|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 73% to achieve noninferiority.|Percentage of Participants|99.5|||||TWO_SIDED|95.0|98.6|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution.|For the primary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per treatment arm provides \>95% power to demonstrate noninferiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (84%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|98.6|
70889592|NCT01767116|141265148|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus placebo RBV treatment group as compared with the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group was analyzed using a noninferiority margin of -10.5%. The lower confidence bound of the 2-sided 95% CI for the difference in percentage of participants with sustained virologic response at 12 weeks after treatment must exceed -10.5% to achieve noninferiority.|Difference in Percentage of Participants|0.5|||||TWO_SIDED|95.0|-0.5|1.4|||||95% CI was calculated using the normal approximation to the binomial distribution.|For the secondary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a -10% margin, a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per arm provides \>95% power to demonstrate noninferiority of ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV compared with ABT-450/r/ABT-267 and ABT-333, plus RBV (normal approximation of a single binomial proportion in a 1-sample test for superiority).||1.4|-0.5|
70889593|NCT01767116|141265149|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||||||<0.001
70889594|NCT01767116|141265150|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|100.0|||||TWO_SIDED|95.0|98.2|100.0|||||95% CI calculated using the Wilson score method for the single proportion; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 84% to achieve superiority.|For the secondary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per treatment arm provides \>90% power to demonstrate superiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (84%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|98.2|
70889595|NCT01767116|141265150|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|99.5|||||TWO_SIDED|95.0|98.6|100.0|||||95% CI calculated using the normal approximation to the binomial distribution; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 84% to achieve superiority.|For the secondary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per treatment arm provides \>90% power to demonstrate superiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (84%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|98.6|
70889596|NCT00752908|141265163|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70889597|NCT00153101|141265165|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.8462||95.0|0.92|1.07|||Regression, Cox|||||1.07|0.92|0.8462
70889598|NCT00153101|141265165|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin was 1.13|Hazard Ratio (HR)|1.01||||0.0019||97.5|0.93|1.1|||Regression, Cox|||||1.10|0.93|0.0019
70889599|NCT00153101|141265166|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9086||95.0|0.93|1.09|||Regression, Cox|||||1.09|0.93|0.9086
70889600|NCT00153101|141265166|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin was 1.13|Hazard Ratio (HR)|0.99||||0.0004||97.5|0.9|1.08|||Regression, Cox|||||1.08|0.90|0.0004
70889601|NCT00153101|141265167|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.4535||95.0|0.93|1.17|||Regression, Cox|||||1.17|0.93|0.4535
70889602|NCT00153101|141265167|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9421||95.0|0.89|1.12|||Regression, Cox|||||1.12|0.89|0.9421
70889603|NCT00153101|141265168|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.2909||95.0|0.94|1.23|||Regression, Cox|||||1.23|0.94|0.2909
70889604|NCT00153101|141265168|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.2534||95.0|0.94|1.24|||Regression, Cox|||||1.24|0.94|0.2534
70889605|NCT00153101|141265169|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.2248||95.0|0.79|1.06|||Regression, Cox|||||1.06|0.79|0.2248
70889606|NCT00153101|141265169|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.1829||95.0|0.79|1.05|||Regression, Cox|||||1.05|0.79|0.1829
70889607|NCT00153101|141265170|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.4984||95.0|0.82|1.1|||Regression, Cox|||||1.10|0.82|0.4984
70889608|NCT00153101|141265170|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12||||0.1203||95.0|0.97|1.29|||Regression, Cox|||||1.29|0.97|0.1203
70889609|NCT00153101|141265171|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.4221|TWO_SIDED|95.0|0.73|2.15|||Regression, Cox|||||2.15|0.73|0.4221
70889610|NCT00153101|141265171|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.7305||95.0|0.51|1.6|||Regression, Cox|||||1.60|0.51|0.7305
70889611|NCT00153101|141265172|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.6248||95.0|0.54|1.45|||Regression, Cox|||||1.45|0.54|0.6248
70889612|NCT00153101|141265172|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.0751|TWO_SIDED|95.0|0.36|1.05|||Regression, Cox|||||1.05|0.36|0.0751
70889613|NCT00153101|141265173|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.3682||95.0|0.63|1.18|||Regression, Cox|||||1.18|0.63|0.3682
70889614|NCT00153101|141265173|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.6014||95.0|0.69|1.24|||Regression, Cox|||||1.24|0.69|0.6014
70889615|NCT00153101|141265174|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.255||95.0|0.91|1.42|||Regression, Cox|||||1.42|0.91|0.2550
70889616|NCT00153101|141265174|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.5297||95.0|0.86|1.34|||Regression, Cox|||||1.34|0.86|0.5297
70889617|NCT00153101|141265175|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.4593||95.0|0.82|1.56|||Regression, Cox|||||1.56|0.82|0.4593
70889618|NCT00153101|141265175|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.7468||95.0|0.68|1.32|||Regression, Cox|||||1.32|0.68|0.7468
70889619|NCT00153101|141265176|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.5461|TWO_SIDED|95.0|0.71|1.2|||Regression, Cox|||||1.20|0.71|0.5461
70889620|NCT00153101|141265176|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.3436||95.0|0.68|1.14|||Regression, Cox|||||1.14|0.68|0.3436
70889621|NCT00153101|141265177|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.0133||95.0|0.8|0.97|||Regression, Cox|||||0.97|0.80|0.0133
70889622|NCT00153101|141265177|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.1251||95.0|0.84|1.02|||Regression, Cox|||||1.02|0.84|0.1251
70889623|NCT00153101|141265178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.0213||95.0|0.67|0.97|||Regression, Cox|||||0.97|0.67|0.0213
70889624|NCT00153101|141265178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.2396||95.0|0.75|1.07|||Regression, Cox|||||1.07|0.75|0.2396
70889625|NCT00153101|141265179|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.0111||95.0|0.83|0.98|||Regression, Cox|||||0.98|0.83|0.0111
70889626|NCT00153101|141265179|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.0606||95.0|0.85|1.0|||Regression, Cox|||||1.00|0.85|0.0606
70889627|NCT00153101|141265180|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.0082||95.0|1.05|1.35|||Regression, Cox|||||1.35|1.05|0.0082
70889628|NCT00153101|141265180|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.2164||95.0|0.95|1.23|||Regression, Cox|||||1.23|0.95|0.2164
70889629|NCT00153101|141265181|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.3732||95.0|0.83|1.07|||Regression, Cox|||||1.07|0.83|0.3732
70889630|NCT00153101|141265181|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.3633||95.0|0.94|1.2|||Regression, Cox|||||1.20|0.94|0.3633
70889631|NCT00153101|141265182|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.2713||95.0|0.97|1.13|||Regression, Cox|||||1.13|0.97|0.2713
70889632|NCT00153101|141265182|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.515||95.0|0.95|1.11|||Regression, Cox|||||1.11|0.95|0.5150
70889633|NCT00153101|141265183|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.3485||95.0|0.77|1.1|||Regression, Cox|||for subjects without diabetes at baseline||1.10|0.77|0.3485
70889634|NCT00153101|141265183|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.1235||95.0|0.96|1.36|||Regression, Cox|||for subjects without diabetes at baseline||1.36|0.96|0.1235
70889635|NCT00153101|141265184|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99||||0.869||95.0|0.89|1.11|||Chi-squared|||for subjects with available Mini Mental State Examination (MMSE) at baseline||1.11|0.89|0.8690
70889636|NCT00153101|141265184|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.04||||0.4337||95.0|0.94|1.17|||Chi-squared|||for subjects with available Mini Mental State Examination (MMSE) at baseline||1.17|0.94|0.4337
70889637|NCT00153101|141265185|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.2666||95.0|0.83|1.05|||Regression, Cox|||for subjects without atrial fibrillation at baseline||1.05|0.83|0.2666
70889638|NCT00153101|141265185|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.4784||95.0|0.85|1.08|||Regression, Cox|||for subjects without atrial fibrillation at baseline||1.08|0.85|0.4784
70889639|NCT00153101|141265186|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.0483||95.0|0.76|1.0|||Regression, Cox|||||1.00|0.76|0.0483
70889640|NCT00153101|141265187|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.2192||95.0|0.81|1.05|||Regression, Cox|||||1.05|0.81|0.2192
70889641|NCT00153101|141265188|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.7764||95.0|0.85|1.24|||Regression, Cox|||||1.24|0.85|0.7764
70889642|NCT00153101|141265189|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0574||95.0|0.62|1.01|||Regression, Cox|||||1.01|0.62|0.0574
70889643|NCT00153101|141265190|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.1365||95.0|0.64|1.06|||Regression, Cox|||||1.06|0.64|0.1365
70889644|NCT00153101|141265191|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.694||95.0|0.82|1.34|||Regression, Cox|||||1.34|0.82|0.6940
70889645|NCT00153101|141265192|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.58||||0.0245||95.0|1.06|2.35|||Regression, Cox|||||2.35|1.06|0.0245
70889646|NCT00153101|141265193|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.5798||95.0|0.36|1.76|||Regression, Cox|||||1.76|0.36|0.5798
70889647|NCT00153101|141265194|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.0006||95.0|0.65|0.89|||Regression, Cox|||||0.89|0.65|0.0006
70889648|NCT00153101|141265195|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.0085||95.0|0.48|0.9|||Regression, Cox|||||0.90|0.48|0.0085
70889649|NCT00153101|141265196|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.0015||95.0|0.69|0.92|||Regression, Cox|||||0.92|0.69|0.0015
70889650|NCT00153101|141265197|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.39||||0.0101||95.0|1.08|1.79|||Regression, Cox|||||1.79|1.08|0.0101
70889651|NCT00153101|141265198|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9563||95.0|0.82|1.24|||Regression, Cox|||||1.24|0.82|0.9563
70889652|NCT00153101|141265199|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.17||||0.0868||95.0|0.98|1.41|||Chi-squared|||||1.41|0.98|0.0868
70889653|NCT00153101|141265200|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.0172||95.0|0.6|0.95|||Regression, Cox|||||0.95|0.60|0.0172
70889654|NCT00153101|141265201|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.1431||95.0|0.78|1.04|||Regression, Cox|||||1.04|0.78|0.1431
70889655|NCT00153101|141265202|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.8974||95.0|0.81|1.21|||Regression, Cox|||||1.21|0.81|0.8974
70889656|NCT02610140|141265203|SUPERIORITY||Hazard Ratio (HR)|1.215||||0.859125|TWO_SIDED|95.0|0.85|||1-sided p-value from log-rank test (stratified by TTP on 1st line treatment). P-value is calculated based on alpha level 0.0125.|Log Rank||Hazard ratio (anetumab ravtansine / vinorelbine) was estimated using Cox proportional hazards models with Wald CIs, stratified by Time to progression (TTP) on 1st line treatment.|PFS anetumab ravtansine / vinorelbine||1,738|0.850|0.859125
70889657|NCT02610140|141265204|SUPERIORITY||Hazard Ratio (HR)|1.072||||0.655624|TWO_SIDED|95.0|0.763|1.506||1-sided p-value from log-rank test (stratified by TTP on 1st line treatment). Alpha spending/boundary for interim was 0.00245. Alpha boundary value for final analysis was 0.02421.|Log Rank||Hazard ratio (anetumab ravtansine/vinorelbine) was estimated using Cox proportional hazards models with Wald CIs, stratified by TTP on 1st line treatment.|OS anetumab ravtansine / vinorelbine||1.506|0.763|0.655624
70889658|NCT02610140|141265209|SUPERIORITY||Difference (%) improvement rate symptoms|4.65||||0.244|TWO_SIDED|95.0|-8.2|17.51|||Cochran-Mantel-Haenszel|1-sided Cochran-Mantel-Haenszel test, stratified by TTP on 1st line treatment||Anetumab ravtansine versus vinorelbine||17.51|-8.20|0.244
70889659|NCT02610140|141265210|SUPERIORITY||Hazard Ratio (HR)|0.829||||0.313747|TWO_SIDED|95.0|0.386|1.779|||Log Rank|one-sided log-rank test stratified by time to progression (TTP) on first line treatment||Anetumab ravtansine versus vinorelbine||1.779|0.386|0.313747
70889660|NCT02610140|141265211|SUPERIORITY||Hazard Ratio (HR)|0.924||||0.378916|TWO_SIDED|95.0|0.557|1.533|||Log Rank|one-sided log-rank test stratified by time to progression (TTP) on first line treatment||Anetumab ravtansine versus vinorelbine||1.533|0.557|0.378916
70889661|NCT02610140|141265212|SUPERIORITY||Difference (%) improvement rate of pain|6.64||||0.214|TWO_SIDED|95.0|-9.4|22.68|||Cochran-Mantel-Haenszel|1-sided Cochran-Mantel-Haenszel test, stratified by TTP on 1st line treatment||||22.68|-9.40|0.214
70889662|NCT02610140|141265215|SUPERIORITY||Mean Difference (Final Values)|9.5|||||TWO_SIDED|95.0|0.1|39.3||||||||39.3|0.1|
70889663|NCT02610140|141265215|SUPERIORITY||Mean Difference (Final Values)|11.6|||||TWO_SIDED|95.0|0.0|35.9||||||||35.9|0.0|
70889664|NCT03169153|141265216|SUPERIORITY||||||<|0.0001|||||||Mixed effects repeated measures|||||||<0.0001
70889665|NCT01975389|141265218|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.021469|TWO_SIDED|95.0|0.65|0.97|||Log Rank|||Hazard ratio and 95% Confidence Interval (CI) were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.97|0.65|0.021469
70889666|NCT01975389|141265219|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.007597|TWO_SIDED|95.0|0.6|0.93|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.93|0.60|0.007597
70889667|NCT01975389|141265220|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.035958|TWO_SIDED|95.0|0.68|0.99|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.99|0.68|0.035958
70889668|NCT01975389|141265221|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.015694|TWO_SIDED|95.0|0.64|0.95|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.95|0.64|0.015694
70889669|NCT01975389|141265222|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.814224|TWO_SIDED|95.0|0.62|1.46|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.46|0.62|0.814224
70889670|NCT01975389|141265223|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.018053|TWO_SIDED|95.0|0.65|0.96|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.96|0.65|0.018053
70889671|NCT01975389|141265224|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.446033|TWO_SIDED|95.0|0.5|1.36|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.36|0.50|0.446033
70889672|NCT01975389|141265225|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.029977|TWO_SIDED|95.0|0.57|0.97|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.97|0.57|0.029977
70889673|NCT01975389|141265226|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.162615|TWO_SIDED|95.0|0.14|1.44|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.44|0.14|0.162615
70889674|NCT01975389|141265227|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.051534|TWO_SIDED|95.0|0.59|1.0|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.00|0.59|0.051534
70889675|NCT01975389|141265228|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.104998|TWO_SIDED|95.0|0.41|1.09|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.09|0.41|0.104998
70889676|NCT01975389|141265229|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.294331|TWO_SIDED|95.0|0.5|1.24|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.24|0.50|0.294331
70889677|NCT01975389|141265231|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.104998|TWO_SIDED|95.0|0.41|1.09|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.09|0.41|0.104998
70889678|NCT01975389|141265232|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.6012|TWO_SIDED|95.0|0.6|1.34|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.34|0.60|0.601200
70889679|NCT01975389|141265233|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.678061|TWO_SIDED|95.0|0.72|1.67|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.67|0.72|0.678061
70889680|NCT01975389|141265234|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.010457|TWO_SIDED|95.0|0.63|0.94|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.94|0.63|0.010457
70889681|NCT01975389|141265235|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.509847|TWO_SIDED|95.0|0.71|2.01|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||2.01|0.71|0.509847
70889682|NCT01975389|141265236|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.002981|TWO_SIDED|95.0|0.58|0.9|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.90|0.58|0.002981
70889683|NCT01975389|141265237|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.748975|TWO_SIDED|95.0|0.7|1.3|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.30|0.70|0.748975
70889684|NCT01975389|141265238|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.626157|TWO_SIDED|95.0|0.63|1.32|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.32|0.63|0.626157
70889685|NCT01975389|141265239|SUPERIORITY||LS mean difference|-56.9|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|-57.91|-55.89|||MMRM|||Least square (LS) mean differences, associated 95% CI, and p-values were from an mixed model repeated measures (MMRM) model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-55.89|-57.91|<0.001
70889686|NCT01975389|141265240|SUPERIORITY||LS mean difference|-73.8|STANDARD_ERROR_OF_MEAN|0.67|<|0.001|TWO_SIDED|95.0|-75.11|-72.5|||MMRM|||LS mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-72.50|-75.11|<0.001
70889687|NCT01975389|141265241|SUPERIORITY||LS mean difference|-39.31|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-40.55|-38.06|||ANCOVA|||LS-mean difference, associated 95% CI, and p-value were from an analysis of covariance (ANCOVA) model with fixed effects for treatment group, baseline value, geographic region and complete statin intolerance.||-38.06|-40.55|<0.001
70889688|NCT01975389|141265242|SUPERIORITY||LS mean difference|-51.87|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|-52.81|-50.94|||MMRM|||Non-HDLC: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-50.94|-52.81|<0.001
70889689|NCT01975389|141265242|SUPERIORITY||LS mean difference|-18.41|STANDARD_ERROR_OF_MEAN|0.79|<|0.001|TWO_SIDED|95.0|-19.96|-16.86|||MMRM|||VLDL-C: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-16.86|-19.96|<0.001
70889690|NCT01975389|141265242|SUPERIORITY||LS mean difference|-29.2|STANDARD_ERROR_OF_MEAN|1.14|<|0.001|TWO_SIDED|95.0|-31.44|-26.96|||MMRM|||RLP-C: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-26.96|-31.44|<0.001
70889691|NCT01975389|141265242|SUPERIORITY||LS mean difference|-51.4|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-52.37|-50.42|||MMRM|||Apo B: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 52 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-50.42|-52.37|<0.001
70889692|NCT01975389|141265242|SUPERIORITY||LS mean difference|6.91|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|6.33|7.5|||MMRM|||HDL-C: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||7.50|6.33|<0.001
70889693|NCT01975389|141265242|SUPERIORITY||LS mean difference|4.4|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|3.9|4.9|||MMRM|||Apo A-I: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 52 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||4.90|3.90|<0.001
70889694|NCT01975389|141265242|SUPERIORITY||LS mean difference|-37.99|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-38.75|-37.22|||MMRM|||Total cholesterol: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-37.22|-38.75|<0.001
70889695|NCT01975389|141265243|SUPERIORITY||LS mean difference|0.82|||<|0.001|TWO_SIDED|95.0|0.81|0.83|||MMRM|||Triglycerides: LS-mean differences, associated 95% CI and p-values were from an MMRM model including observations through Week 70 on the difference of log-transformed observations with fixed effects for treatment group, visit, treatment group\*visit interaction, log-transformed baseline value, log-transformed baseline value\*visit interaction, geographical region and complete statin intolerance. The 95% CI was derived by exponentiating the LS-mean difference confidence interval from the log scale.||0.83|0.81|<0.001
70889696|NCT01975389|141265243|SUPERIORITY||LS mean difference|0.68|||<|0.001|TWO_SIDED|95.0|0.67|0.69|||MMRM|||Lp(a): LS-mean differences, associated 95% CI and p-values were from an MMRM model on the Difference of log-transformed observations with fixed effects for treatment group, visit, a treatment group\*visit interaction, log-transformed baseline value, log-transformed baseline value\*visit interaction, geographical region and complete statin intolerance. The 95% CI was derived by exponentiating the LS-mean difference confidence interval from the log scale.||0.69|0.67|<0.001
70889697|NCT01975389|141265244|SUPERIORITY||LS mean difference|1.06||||0.002|TWO_SIDED|95.0|1.02|1.09|||MMRM|||LS-mean differences, associated 95% CI and p-values were from an MMRM model on the difference of log-transformed observations with fixed effects for treatment group, visit, treatment group\*visit interaction, log-transformed baseline value, log-transformed baseline value\*visit interaction, geographical region and complete statin intolerance.||1.09|1.02|0.002
70889698|NCT04278417|141265256|NON_INFERIORITY|Non-inferiority of brolucizumab to PRP with respect to change from baseline in BCVA at Week 54, considering a non-inferiority margin of 4 ETDRS letters. Assuming that the BCVA changes follow a normal distribution with equal means between treatments, and a common standard deviation of 10 letters, for a one-sided alpha level of 0.025, with 300 subjects per arm there is \>99% power to reject the null hypothesis that brolucizumab 6 mg is inferior to PRP.|LS mean difference|4.4|STANDARD_ERROR_OF_MEAN|1.03|<|0.001|TWO_SIDED|95.0|2.4|6.4|||ANCOVA|||1||6.4|2.4|<0.001
70889699|NCT04278417|141265256|SUPERIORITY||||||<|0.001|||||||ANCOVA|||2||||<0.001
70889700|NCT04278417|141265257|SUPERIORITY||Difference in % of Participants|39.4|||<|0.001|TWO_SIDED|95.0|32.0|46.8|||Cochran-Mantel-Haenszel|||||46.8|32.0|< 0.001
70889701|NCT04278417|141265259|SUPERIORITY||Difference in % of Participants|-41.1|||<|0.001|TWO_SIDED|95.0|-48.0|-34.2|||Cochran-Mantel-Haenszel|||||-34.2|-48.0|< 0.001
70889702|NCT04278417|141265262|SUPERIORITY||Difference in % of Participants|26.4|||<|0.001|TWO_SIDED|95.0|19.5|33.3|||Cochran-Mantel-Haenszel|||Week 54||33.3|19.5|<0.001
70889703|NCT01306617|141265284|SUPERIORITY_OR_OTHER|||||||0.547|TWO_SIDED||||||Regression, Logistic|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||For the percentage of subjects with HCV RNA suppressed below the LLOD from Week 4 through Week 12, if it was assumed that 60% of subjects would be successfully suppressed from Week 4 through Week 12, then 20 subjects in arm 1 would give a 95% 2-sided confidence interval (CI) of (38.5%, 81.5%), 10 subjects in arm 2 would give a 95% CI of (29.6%, 90.4%), and 15 subjects in arm 3 would give a 95% CI of (35.2%, 84.8%) for the percentage of subjects suppressed using the binomial exact method.||||0.547
70889704|NCT01306617|141265284|SUPERIORITY_OR_OTHER|||||||0.207|TWO_SIDED||||||Regression, Logistic|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.207
70889705|NCT01306617|141265285|SUPERIORITY_OR_OTHER|||||||0.061|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.061
70889706|NCT01306617|141265286|SUPERIORITY_OR_OTHER|||||||0.061|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.061
70889707|NCT01306617|141265286|SUPERIORITY_OR_OTHER|||||||0.375|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.375
70889708|NCT01306617|141265287|SUPERIORITY_OR_OTHER|||||||0.312|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.312
70889709|NCT01306617|141265287|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.012
70889710|NCT01306617|141265288|SUPERIORITY_OR_OTHER|||||||0.312|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.312
70889711|NCT01306617|141265288|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.012
70889712|NCT01306617|141265289|SUPERIORITY_OR_OTHER|||||||0.395|TWO_SIDED||||||Log Rank|||||||0.395
70889713|NCT01306617|141265289|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Log Rank|||||||0.010
70889714|NCT01306617|141265290|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||Log Rank|||||||0.048
70889715|NCT04028388|141265296|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.1465|TWO_SIDED|95.0|0.56|2.65|||Wilcoxon (Mann-Whitney)|||||2.65|0.56|0.1465
70889716|NCT04028388|141265300|SUPERIORITY||Hazard Ratio (HR)|1.76||||0.4576|TWO_SIDED|95.0|0.39|7.93|||Log Rank|||DOR is calculated in the subpopulation of subjects experiencing a response (CR or PR). Hazard Ratio \< 1 means that tested drug (ModraDoc006/r) has better outcome.||7.93|0.39|0.4576
70889717|NCT04028388|141265301|SUPERIORITY||Hazard Ratio (HR)|1.5||||0.0776|TWO_SIDED|95.0|0.65|3.48|||Wilcoxon (Mann-Whitney)|||"Difference between the cohorts is tested with Log-rank test and estimated using Univariate Cox model.~Wilcoxon test is used if proportional hazards assumption is not fulfilled. Hazard Ratio \< 1 means that tested drug (ModraDoc006/r) has better outcome"||3.48|0.65|0.0776
70889718|NCT04028388|141265303|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.2539|TWO_SIDED|95.0|0.79|2.49|||Log Rank|||"Difference between the cohorts is tested with Log-rank test and estimated using Univariate Cox model.~Wilcoxon test is used if proportional hazards assumption is not fulfilled. Hazard Ratio \< 1 means that tested drug (ModraDoc006/r) has better outcome."||2.49|0.79|0.2539
70889719|NCT04028388|141265304|SUPERIORITY||Hazard Ratio (HR)|1.35||||0.3062|TWO_SIDED|95.0|0.76|2.42|||Wilcoxon (Mann-Whitney)|||"Difference between the cohorts is tested with Log-rank test and estimated using Univariate Cox model.~Wilcoxon test is used if proportional hazards assumption is not fulfilled. Hazard Ratio \< 1 means that tested drug (ModraDoc006/r) has better outcome."||2.42|0.76|0.3062
70889720|NCT01114516|141265310|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||Log Rank|||Kaplan Meier survival analysis||||0.018
70889721|NCT01114516|141265311|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.48|||||TWO_SIDED|95.0|1.06|2.05||||||||2.05|1.06|
70889722|NCT01114516|141265312|SUPERIORITY_OR_OTHER|||||||0.393|TWO_SIDED||||||Kruskal-Wallis|||||||0.393
70889723|NCT00129259|141265315|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|P-value for testing treatment effect uses change in ln(AUC+1) as the outcome variable and adjusts for baseline ln(AUC+1).||"Null hypothesis: The mean change from baseline to Month 24 in the 4-hour C-peptide AUC does not differ between treatment groups after adjusting for baseline C-peptide AUC.~Alternative hypothesis: The mean change from baseline to Month 24 in the 4-hour C-peptide AUC differs between the treatment groups after adjusting for baseline values."||||0.002
70889724|NCT00129259|141265316|SUPERIORITY_OR_OTHER|||||||0.697||95.0|||||ANCOVA|ANCOVA adjusts for baseline HbA1c.||"Null hypothesis: The mean change in HbA1c from baseline (pre-treatment) to Month 24 does not differ between treatment groups.~Alternative hypothesis: The mean change in HbA1c from baseline to Month 24 differs between treatment groups."||||0.697
70889725|NCT00129259|141265317|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANCOVA|ANCOVA adjusts for baseline daily insulin use per kg||"Null hypothesis: The mean change from baseline to Month 24 in daily insulin use per kg does not differ between the treatment and control groups.~Alternative hypothesis: The mean change from baseline to Month 24 in daily insulin use per kg differs between the treatment and control groups."||||0.110
70889726|NCT01940705|141265347|SUPERIORITY||Mean Difference (Final Values)|5.578||||0.001|TWO_SIDED||||||ANOVA|||Analysis for Hearing Aid Skills and Knowledge test Skills scale||||0.001
70889727|NCT01940705|141265347|SUPERIORITY||Mean Difference (Final Values)|4.235||||0.003|TWO_SIDED||||||ANOVA|||Analysis for Hearing Aid Skills and Knowledge test Knowledge scale||||0.003
70889728|NCT01940705|141265348|SUPERIORITY||Mean Difference (Final Values)|0.956||||0.414|TWO_SIDED||||||ANOVA|||||||0.414
70889729|NCT01940705|141265349|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.847|TWO_SIDED||||||ANOVA|||||||0.847
70889730|NCT00139997|141265350|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||t-test, 2 sided|||||||0.028
70889731|NCT00612313|141265370|SUPERIORITY_OR_OTHER||Difference in percentages|9.7||||0.02|TWO_SIDED|||||The estimated rate of time spent well was evaluated using a Poisson regression with adjustment for CDRS-R score at the end of the acute phase, age group, and gender.|Regression, Poisson||Differencein percentages represents estimated percentage for medication management + CBT Arm minus estimated percentage for medication management only Arm.|||||.02
70889732|NCT05955560|141265391|SUPERIORITY|||||||0.04||||||A two-sided paired t-test was used and p-value derived. The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||||0.04
70889733|NCT04621500|141265396|OTHER|The sequencing transcriptional profile cannot be analyzed by a statistical method.|||||||||||||||||In this open label study, the RNA sequencing transcription analysis was performed to assess if the transcriptome would be modified by vitamin D supplementation and it uniformaly was.|||
70889734|NCT02710630|141265422|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|119.33|STANDARD_DEVIATION|40.4|||TWO_SIDED|90.0|101.838|139.834|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||139.834|101.838|
70889735|NCT02710630|141265422|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|52.97|STANDARD_DEVIATION|168.9|||TWO_SIDED|90.0|33.341|84.158|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||84.158|33.341|
70889736|NCT02710630|141265422|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|59.01|STANDARD_DEVIATION|73.4|||TWO_SIDED|90.0|45.255|76.955|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||76.955|45.255|
70889737|NCT02710630|141265422|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|108.21|STANDARD_DEVIATION|55.7|||TWO_SIDED|90.0|87.698|133.53|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||133.530|87.698|
70889738|NCT02710630|141265422|SUPERIORITY_OR_OTHER||Ratio|110.21|STANDARD_DEVIATION|41.1|||TWO_SIDED|90.0|93.939|129.297|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||129.297|93.939|
70889739|NCT02710630|141265423|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|118.31|STANDARD_DEVIATION|44.2|||TWO_SIDED|90.0|99.569|140.579|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||140.579|99.569|
70889740|NCT02710630|141265423|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|57.49|STANDARD_DEVIATION|132.3|||TWO_SIDED|90.0|38.502|85.837|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||85.837|38.502|
70889741|NCT02710630|141265423|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|61.94|STANDARD_DEVIATION|69.0|||TWO_SIDED|90.0|48.13|79.72|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||79.720|48.130|
70889742|NCT02710630|141265423|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|108.26|STANDARD_DEVIATION|55.8|||TWO_SIDED|90.0|87.704|133.629|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||133.629|87.704|
70889743|NCT02710630|141265423|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|107.76|STANDARD_DEVIATION|43.0|||TWO_SIDED|90.0|91.238|127.281|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||127.281|91.238|
70889744|NCT02710630|141265424|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|118.26|STANDARD_DEVIATION|38.5|||TWO_SIDED|90.0|101.627|137.621|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||137.621|101.627|
70889745|NCT02710630|141265424|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|87.26|STANDARD_DEVIATION|60.2|||TWO_SIDED|90.0|69.404|109.722|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||109.722|69.404|
70889746|NCT02710630|141265424|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|71.4|STANDARD_DEVIATION|49.2|||TWO_SIDED|90.0|58.828|86.648|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||86.648|58.828|
70889747|NCT02710630|141265424|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|116.67|STANDARD_DEVIATION|37.7|||TWO_SIDED|90.0|100.516|135.41|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||135.410|100.516|
70889748|NCT02710630|141265424|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|109.85|STANDARD_DEVIATION|38.7|||TWO_SIDED|90.0|94.452|127.75|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||127.750|94.452|
70889749|NCT02710630|141265425|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|115.69|STANDARD_DEVIATION|40.2|||TWO_SIDED|90.0|98.783|135.491|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||135.491|98.783|
70889750|NCT02710630|141265425|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|50.43|STANDARD_DEVIATION|173.7|||TWO_SIDED|90.0|31.519|80.689|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||80.689|31.519|
70889751|NCT02710630|141265425|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|56.71|STANDARD_DEVIATION|74.2|||TWO_SIDED|90.0|43.388|74.122|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||74.122|43.388|
70889752|NCT02710630|141265425|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|106.99|STANDARD_DEVIATION|52.8|||TWO_SIDED|90.0|87.554|130.732|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||130.732|87.554|
70889753|NCT02710630|141265425|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|107.07|STANDARD_DEVIATION|40.7|||TWO_SIDED|90.0|91.399|125.432|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||125.432|91.399|
70889754|NCT02710630|141265426|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|115.39|STANDARD_DEVIATION|45.3|||TWO_SIDED|90.0|96.74|137.644|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||137.644|96.740|
70889755|NCT02710630|141265426|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|54.12|STANDARD_DEVIATION|138.6|||TWO_SIDED|90.0|35.818|81.774|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||81.774|35.818|
70889756|NCT02710630|141265426|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|58.96|STANDARD_DEVIATION|71.4|||TWO_SIDED|90.0|45.489|76.431|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||76.431|45.489|
70889757|NCT02710630|141265426|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|106.38|STANDARD_DEVIATION|57.0|||TWO_SIDED|90.0|85.846|131.836|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||131.836|85.846|
70889758|NCT02710630|141265426|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|103.73|STANDARD_DEVIATION|43.3|||TWO_SIDED|90.0|87.74|122.628|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||122.628|87.740|
70889759|NCT02710630|141265427|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|115.27|STANDARD_DEVIATION|38.4|||TWO_SIDED|90.0|99.063|134.13|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||134.130|99.063|
70889760|NCT02710630|141265427|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|83.73|STANDARD_DEVIATION|62.8|||TWO_SIDED|90.0|66.033|106.163|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||106.163|66.033|
70889761|NCT02710630|141265427|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|68.77|STANDARD_DEVIATION|50.3|||TWO_SIDED|90.0|56.452|83.782|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||83.782|56.452|
70889762|NCT02710630|141265427|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|107.13|STANDARD_DEVIATION|49.6|||TWO_SIDED|90.0|88.616|129.51|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||129.510|88.616|
70889763|NCT02710630|141265427|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|106.64|STANDARD_DEVIATION|38.9|||TWO_SIDED|90.0|91.625|124.114|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||124.114|91.625|
70889764|NCT02461589|141265428|OTHER||Treatment difference|-1.04|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.77|||Mixed Models Analysis|||||-0.77|-1.30|<0.0001
70889765|NCT02461589|141265428|OTHER||Treatment difference|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.61|-1.08|||Mixed Models Analysis|||||-1.08|-1.61|<0.0001
70889766|NCT02461589|141265428|OTHER||Treatment difference|-1.69|||<|0.0001|TWO_SIDED|95.0|-1.95|-1.42|||Mixed Models Analysis|||||-1.42|-1.95|<0.0001
70889767|NCT02461589|141265428|OTHER||Treatment difference|-1.86|||<|0.0001|TWO_SIDED|95.0|-2.12|-1.6|||Mixed Models Analysis|||||-1.60|-2.12|<0.0001
70889768|NCT01978119|141265432|NON_INFERIORITY_OR_EQUIVALENCE|Non- inferiority was demonstrated if lower limit of the CI (0.025 one sided significance level) for the difference of the mean change from Baseline in trough FEV1 of FSC administered BID by capsule-based unit dose DPI versus FSC administered BID by multi-dose DPI is greater than -125 milliliter (mL).|Mean Difference (Net)|0.028|||||TWO_SIDED|95.0|-0.024|0.08|||Repeated Measures Mixed Models|||||0.080|-0.024|
70889769|NCT01978119|141265433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.352|||||TWO_SIDED|95.0|-1.039|0.334||||||||0.334|-1.039|
70889770|NCT01978119|141265434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|||||TWO_SIDED|95.0|-0.372|0.927||||||||0.927|-0.372|
70889771|NCT01978119|141265435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.007|||||TWO_SIDED|95.0|-0.074|0.088|||||Day 28 Change from Baseline Analysis|||0.088|-0.074|
70889772|NCT01978119|141265435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.022||||||95.0|-0.049|0.092|||||Day 56 Change from Baseline Analysis|||0.092|-0.049|
70889773|NCT01978119|141265436|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.35|||||TWO_SIDED|95.0|-1.34|10.05||||||||10.05|-1.34|
70889774|NCT01978119|141265437|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06|||||TWO_SIDED|95.0|-0.2|0.09||||||||0.09|-0.20|
70889775|NCT01978119|141265439|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.25|||||TWO_SIDED|95.0|-6.97|2.46||||||||2.46|-6.97|
70889776|NCT01978119|141265440|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.9|0.5||||||||0.5|-0.9|
70889777|NCT01978119|141265441|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.77|||||TWO_SIDED|95.0|-4.64|3.11||||||||3.11|-4.64|
70889778|NCT01958918|141265490|SUPERIORITY|||||||0.185|||||||ANOVA|||||||0.1850
70889779|NCT02114892|141265497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.131|||||||Wilcoxon (Mann-Whitney)|||||||0.131
70889780|NCT02114892|141265498|SUPERIORITY_OR_OTHER_LEGACY|||||||0.859|||||||Wilcoxon (Mann-Whitney)|||||||0.859
70889781|NCT02114892|141265499|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.070
70889782|NCT02114892|141265500|SUPERIORITY_OR_OTHER_LEGACY|||||||0.338|||||||Wilcoxon (Mann-Whitney)|||||||0.338
70889783|NCT02114892|141265501|SUPERIORITY_OR_OTHER_LEGACY|||||||0.278|||||||Wilcoxon (Mann-Whitney)|||||||0.278
70889784|NCT02114892|141265502|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
70889785|NCT02114892|141265503|SUPERIORITY_OR_OTHER_LEGACY|||||||0.083|||||||Wilcoxon (Mann-Whitney)|||||||0.083
70889786|NCT02114892|141265504|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
70889787|NCT02114892|141265505|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
70889788|NCT02114892|141265506|SUPERIORITY_OR_OTHER_LEGACY|||||||0.946|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.946
70889789|NCT02114892|141265507|SUPERIORITY_OR_OTHER_LEGACY|||||||0.365|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.365
70889790|NCT02114892|141265508|SUPERIORITY_OR_OTHER_LEGACY|||||||0.557|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.557
70889791|NCT02114892|141265509|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
70889792|NCT02114892|141265510|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
70889793|NCT02114892|141265511|SUPERIORITY_OR_OTHER_LEGACY|||||||0.672|||||||Wilcoxon (Mann-Whitney)|||||||0.672
70889794|NCT04327934|141265515|EQUIVALENCE|We compared groups across treatments||||||0.018|||||||ANOVA|||||||0.018
70889795|NCT04327934|141265516|EQUIVALENCE|We compared across groups and within groups over time.|||||<|0.016|||||||ANOVA|||||||<0.016
70889796|NCT04327934|141265516|EQUIVALENCE|We compared across groups and within groups over time.||||||0.08|||||||ANOVA|||||||0.08
70889797|NCT04327934|141265519|OTHER|||||||0.05||||||Friedman's tests to compare slopes|Friedman's test|||||||0.05
70889798|NCT04327934|141265521|OTHER|||||||0.023|||||||t-test, 2 sided|||||||0.023
70889799|NCT04327934|141265521|OTHER||||||<|0.04|||||||ANOVA|||||||<0.04
70889800|NCT04327934|141265522|EQUIVALENCE|We compared groups across treatments||||||0.0023|||||||ANOVA|||||||0.0023
70889801|NCT04327934|141265523|OTHER||||||<|0.04|||||||ANOVA|||||||<0.04
70889802|NCT04327934|141265524|OTHER||||||<|0.04|||||||ANOVA|||||||<0.04
70889803|NCT03095417|141265530|SUPERIORITY|||||||0.747|||||||Mixed Models Analysis|||||||0.747
70889804|NCT03095417|141265531|SUPERIORITY|||||||0.032|||||||Mixed Models Analysis|||||||0.032
70889805|NCT03095417|141265532|SUPERIORITY|||||||0.264|||||||Mixed Models Analysis|||||||0.264
70889806|NCT03095417|141265533|SUPERIORITY|||||||0.511|||||||Mixed Models Analysis|||||||0.511
70889807|NCT03095417|141265534|SUPERIORITY|||||||0.677|||||||Mixed Models Analysis|||||||0.677
70889808|NCT03095417|141265535|SUPERIORITY|||||||0.815|||||||Mixed Models Analysis|||||||0.815
70889809|NCT03095417|141265536|SUPERIORITY|||||||0.719|||||||Mixed Models Analysis|||||||0.719
70889810|NCT03095417|141265537|SUPERIORITY|||||||0.346|||||||Mixed Models Analysis|||||||0.346
70889811|NCT03095417|141265538|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|||||||0.910
70889812|NCT03095417|141265539|SUPERIORITY|||||||0.794|||||||Mixed Models Analysis|||||||0.794
70889813|NCT03095417|141265540|SUPERIORITY|||||||0.626|||||||Mixed Models Analysis|||||||0.626
70889814|NCT03095417|141265541|SUPERIORITY|||||||0.774|||||||Mixed Models Analysis|||||||0.774
70889815|NCT01410110|141265542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.66|STANDARD_ERROR_OF_MEAN|4.41||0.55|TWO_SIDED|95.0|-11.57|6.25||a prior threshold p \< .05|t-test, 2 sided|df = 40||t-test for equality of means||6.25|-11.57|.55
70889816|NCT01410110|141265543|SUPERIORITY_OR_OTHER||Slope|0.162|STANDARD_ERROR_OF_MEAN|0.94||0.86|TWO_SIDED|95.0|-1.73|2.05||Time X Condition|Mixed Models Analysis|Mixed Models allows for all randomized participants (N=48) to be included in the model.||F Test (df = 1,39.32), Type III Fixed Effects for Time X Condition||2.05|-1.73|.86
70889817|NCT01410110|141265544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.49|STANDARD_ERROR_OF_MEAN|2.41|<|0.31|TWO_SIDED|95.0|-7.36|2.39||a priori threshold p \< .05|t-test, 2 sided|||||2.39|-7.36|<.31
70889818|NCT01410110|141265545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.952||0.87|TWO_SIDED|95.0|-1.77|2.08||a priori threshold p \< .05|t-test, 2 sided|df=39||||2.08|-1.77|.87
70889819|NCT01410110|141265546|SUPERIORITY_OR_OTHER||Slope|-0.37|STANDARD_ERROR_OF_MEAN|0.84||0.67|TWO_SIDED|95.0|-2.07|1.33|||Mixed Models Analysis|Time X Condition||Type III Fixed Effects for Time X Condition F Test (df = 1,36.86)||1.33|-2.07|.67
70889820|NCT01410110|141265547|SUPERIORITY_OR_OTHER||Slope|-0.42|STANDARD_ERROR_OF_MEAN|0.62||0.5|TWO_SIDED|95.0|-1.67|0.83|||Mixed Models Analysis|Time X Condition||Type III Fixed Effects for Time X Condition, F Test F (df = 1,42.4)||.83|-1.67|.50
70889821|NCT01410110|141265548|SUPERIORITY_OR_OTHER||Slope|1.16|STANDARD_ERROR_OF_MEAN|0.42||0.008|TWO_SIDED|95.0|0.32|2.01|||Mixed Models Analysis|Time X Condition||Type III Fixed Effects Time X Condition F Test (df = 1,70.15)||2.01|.32|.008
70889822|NCT01410110|141265549|SUPERIORITY_OR_OTHER||Slope|2.025|STANDARD_ERROR_OF_MEAN|0.93||0.03|TWO_SIDED|95.0|0.169|3.93|||Mixed Models Analysis|Time X Condition||Type III Fixed Effects Time X Condition F Test (df = 1,37.8)||3.93|.169|.03
70889823|NCT01410110|141265550|SUPERIORITY_OR_OTHER||Slope|3.86|STANDARD_ERROR_OF_MEAN|2.77||0.17|TWO_SIDED|95.0|-1.73|9.46||a priori p-value is .05. for two-tailed test. Positive estimated value is in the direction of the experimental condition.|Mixed Models Analysis|Time X Condition||Type III Fixed Effects for Time X Condition F Test (df = 1,39.8)||9.46|-1.73|.17
70889824|NCT01242527|141265581|SUPERIORITY_OR_OTHER||Placebo adjusted % change from baseline|-21.68||||0.005|TWO_SIDED|95.0|-40.7|-2.89||P-value adjusted with Dunnett's procedure for multiple comparisons of Epanova vs olive oil|ANCOVA p-value on ranked data|ANCOVA model with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors|ANCOVA on log-scale TG with baseline value as covariate and treatment and user/non-user of lipid-altering drugs as factors|||-2.89|-40.70|0.005
70889825|NCT01242527|141265581|SUPERIORITY_OR_OTHER||Placebo adjusted % change from baseline|-21.19||||0.007|TWO_SIDED|95.0|-40.32|-2.29||P-value adjusted with Dunnett's procedure for multiple comparisons of Epanova vs olive oil|ANCOVA p-value on ranked data|ANCOVA model with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors|ANCOVA on log-scale TG with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors|||-2.29|-40.32|0.007
70889826|NCT01242527|141265581|SUPERIORITY_OR_OTHER||Placebo adjusted % change from baseline|-26.6|||<|0.001|TWO_SIDED|95.0|-45.12|-8.38||P-value adjusted with Dunnett's procedure for multiple comparisons of Epanova vs olive oil|ANCOVA p-value on ranked data|ANCOVA model with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors|ANCOVA on log-scale TG with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors|||-8.38|-45.12|<0.001
70889827|NCT00887341|141265582|SUPERIORITY_OR_OTHER|||||||0.238|||||||Chi-squared|||||||0.238
70889828|NCT00887341|141265589|SUPERIORITY_OR_OTHER|||||||0.121|||||||Chi-squared|||Week 4||||0.121
70889829|NCT00887341|141265589|SUPERIORITY_OR_OTHER|||||||0.809|||||||Chi-squared|||Week 8||||0.809
70889830|NCT00887341|141265589|SUPERIORITY_OR_OTHER|||||||0.367|||||||Chi-squared|||Week 12||||0.367
70889831|NCT00887341|141265589|SUPERIORITY_OR_OTHER|||||||0.339|||||||Chi-squared|||Week 16||||0.339
70889832|NCT00887341|141265589|SUPERIORITY_OR_OTHER|||||||0.017|||||||Chi-squared|||Week 20||||0.017
70889833|NCT00887341|141265589|SUPERIORITY_OR_OTHER|||||||0.451|||||||Chi-squared|||Final visit||||0.451
70889834|NCT00887341|141265590|SUPERIORITY_OR_OTHER|||||||0.377|||||||Chi-squared|||Week 4||||0.377
70889835|NCT00887341|141265590|SUPERIORITY_OR_OTHER|||||||0.387|||||||Chi-squared|||Week 8||||0.387
70889836|NCT00887341|141265590|SUPERIORITY_OR_OTHER|||||||0.304|||||||Chi-squared|||Week 12||||0.304
70889837|NCT00887341|141265590|SUPERIORITY_OR_OTHER|||||||0.509|||||||Chi-squared|||Week 16||||0.509
70889838|NCT00887341|141265590|SUPERIORITY_OR_OTHER|||||||0.11|||||||Chi-squared|||Week 20||||0.110
70889839|NCT00887341|141265590|SUPERIORITY_OR_OTHER|||||||0.504|||||||Chi-squared|||Final visit||||0.504
70889840|NCT00887341|141265591|SUPERIORITY_OR_OTHER|||||||0.327|||||||Chi-squared|||Week 4||||0.327
70889841|NCT00887341|141265591|SUPERIORITY_OR_OTHER|||||||0.786|||||||Chi-squared|||Week 8||||0.786
70889842|NCT00887341|141265591|SUPERIORITY_OR_OTHER|||||||0.482|||||||Chi-squared|||Week 12||||0.482
70889843|NCT00887341|141265591|SUPERIORITY_OR_OTHER|||||||0.68|||||||Chi-squared|||Week 16||||0.680
70889844|NCT00887341|141265591|SUPERIORITY_OR_OTHER|||||||0.69|||||||Chi-squared|||Week 20||||0.690
70889845|NCT00887341|141265591|SUPERIORITY_OR_OTHER|||||||0.516|||||||Chi-squared|||Final Visit||||0.516
70889846|NCT00887341|141265592|SUPERIORITY_OR_OTHER|||||||0.97|||||||Chi-squared|||Week 8||||0.970
70889847|NCT00887341|141265592|SUPERIORITY_OR_OTHER|||||||0.587|||||||Chi-squared|||Week 12||||0.587
70889848|NCT00887341|141265592|SUPERIORITY_OR_OTHER|||||||0.184|||||||Chi-squared|||Week 16||||0.184
70889849|NCT00887341|141265592|SUPERIORITY_OR_OTHER|||||||0.6|||||||Chi-squared|||Week 20||||0.600
70889850|NCT00887341|141265592|SUPERIORITY_OR_OTHER|||||||0.937|||||||Chi-squared|||Final Visit||||0.937
70889851|NCT01649856|141265597|SUPERIORITY_OR_OTHER||Difference in Response Rates|8.2||||0.076||95.0|-1.1|17.5|||Chi-squared|||||17.5|-1.1|0.076
70889852|NCT01312961|141265643|SUPERIORITY||Odds Ratio (OR)|0.077|||<|0.0001|TWO_SIDED|95.0|0.021|0.28||Threshold for significance at 0.05 level.|Regression, Logistic||Dupilumab 300 mg vs. Placebo|Analysis was performed using a logistic regression model with treatment groups and stratification factor (prior ICS/LABA combination therapy dose) as covariates.||0.280|0.021|<0.0001
70889853|NCT01331694|141265658|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.64||||||95.0|1.5|1.79|||||Hazard ratio for hospitalization or emergency department visit for IP compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.79|1.50|
70889854|NCT01331694|141265658|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||||95.0|1.17|1.41|||||Hazard ratio for hospitalization or emergency department visit for TIO compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.41|1.17|
70889855|NCT01331694|141265658|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.78||||||95.0|1.59|2.0|||||Hazard ratio for emergency department visit for IP compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||2.00|1.59|
70889856|NCT01331694|141265658|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.33||||||95.0|1.17|1.51|||||Hazard ratio for emergency department visit for TIO compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.51|1.17|
70889857|NCT01331694|141265658|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.65||||||95.0|1.41|1.94|||||Hazard ratio for outpatient visit with oral steroid fill for IP compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.94|1.41|
70889858|NCT01331694|141265658|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49||||||95.0|1.26|1.76|||||Hazard ratio for outpatient visit with oral steroid fill for TIO compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.76|1.26|
70889859|NCT01331694|141265658|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.39||||||95.0|1.23|1.57|||||Hazard ratio for outpatient visit with antibiotic fill for IP compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.57|1.23|
70889860|NCT01331694|141265658|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.33||||||95.0|1.17|1.51|||||Hazard ratio for outpatient visit with antibiotic fill for TIO compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.51|1.17|
70889861|NCT04122443|141265727|SUPERIORITY||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|0.3|1.9||||||||1.9|0.3|
70889862|NCT04122443|141265728|SUPERIORITY||Mean Difference (Final Values)|13.0|||||TWO_SIDED|95.0|-3.0|29.0||||||||29|-3|
70889863|NCT04122443|141265729|SUPERIORITY||Mean Difference (Final Values)|9.0|||||TWO_SIDED|95.0|-5.0|23.0||||||||23|-5|
70889864|NCT04122443|141265730|SUPERIORITY||Mean Difference (Final Values)|6.0|||||TWO_SIDED|95.0|-10.0|21.0||||||||21|-10|
70889865|NCT01072201|141265732|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70889866|NCT01072201|141265733|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70889867|NCT01072201|141265734|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups||||0.05
70889868|NCT01130740|141265756|SUPERIORITY_OR_OTHER|||||||0.158|TWO_SIDED||||||Mixed Models Analysis|||This is a comparison of 6-month outcomes between the two study groups. (Primary comparison is for 12 months.)||||0.158
70889869|NCT01130740|141265756|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Mixed Models Analysis|||This is the 12-month comparison between the 2 study groups, which is the primary study analysis.||||0.008
70889870|NCT01130740|141265757|SUPERIORITY_OR_OTHER|||||||0.274|TWO_SIDED||||||Mixed Models Analysis|||This is the between-group 12-month comparison.||||0.274
70889871|NCT01130740|141265758|SUPERIORITY_OR_OTHER|||||||0.177|TWO_SIDED||||||Mixed Models Analysis|||||||0.177
70889872|NCT01431508|141265772|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||t-test, 2 sided|||Comparison of Week 12 and Baseline||||<0.05
70889873|NCT00023452|141265827|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority test statistic was based on the difference of the nonparametric Kaplan-Meier estimators. The asymptotic variance of the test statistic was obtained through Greenwood's formula and a two-sided 95% confidence interval (CI) was constructed for the difference. If the upper bound of the CI was smaller than the noninferiority margin 0.75%, then the null hypothesis would be rejected and noninferiority could be claimed.|Difference in Cumulative TB Disease Rate|-0.24|||||ONE_SIDED|95.0||0.01|||||The difference in cumulative TB disease rate is the rate in the 3RPT/INH arm minus the rate in the 9INH arm.|||0.01||
70889874|NCT00023452|141265828|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority test statistic was based on the difference of the nonparametric Kaplan-Meier estimators. The asymptotic variance of the test statistic was obtained through Greenwood's formula and a two-sided 95% CI was constructed for the difference. If the upper bound of the CI was smaller than the noninferiority margin 0.75%, then the null hypothesis would be rejected and noninferiority could be claimed.|Difference in Cumulative TB Rate|-0.21|||||ONE_SIDED|95.0||0.04|||||The difference in cumulative TB disease rate is the percentage in the 3RPT/INH arm minus the percentage in the 9INH arm.|||0.04||
70889875|NCT00023452|141265829|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority test statistic was based on the difference of the nonparametric Kaplan-Meier estimators. The asymptotic variance of the test statistic was obtained through Greenwood's formula and a two-sided 95% CI was constructed for the difference. If the upper bound of the CI was smaller than the noninferiority margin 0.75%, then the null hypothesis would be rejected and noninferiority could be claimed.|Difference in Cumulative TB Disease Rate|-0.25|||||ONE_SIDED|95.0||0.03|||||The difference in cumulative TB disease rate is the percentage in the 3RPT/INH arm minus the percentage in the 9INH arm.|||0.03||
70889876|NCT00023452|141265830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||Chi-squared|||||||0.02
70889877|NCT00023452|141265831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24||95.0|||||Chi-squared|||Grade 3 Drug Toxicity||||0.24
70889878|NCT00023452|141265831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.59||95.0|||||Chi-squared|||Grade 4 Drug Toxicity||||0.59
70889879|NCT00023452|141265832|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22||95.0|||||Chi-squared|||||||0.22
70889880|NCT00023452|141265834|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
70889881|NCT00023452|141265835|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
70889882|NCT00023452|141265836|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority test statistic was based on the difference of the nonparametric Kaplan-Meier estimators. The asymptotic variance of the test statistic was obtained through Greenwood's formula and a two-sided 95% CI was constructed for the difference. If the upper bound of the CI was smaller than the noninferiority margin 0.75%, then the null hypothesis would be rejected and noninferiority could be claimed.|Difference in Cumulative TB Disease Rate|-0.19|||||ONE_SIDED|95.0||0.06|||||The difference in cumulative TB disease rate is the percentage in the 3RPT/INH arm minus the percentage in the 9INH arm.|||0.06||
70889883|NCT02939105|141265842|OTHER||success proportion|86.7|||||TWO_SIDED|95.0|69.3|96.2||||||||96.2|69.3|
70889884|NCT03779841|141265844|SUPERIORITY||Risk Ratio (RR)|0.8||||0.1612|TWO_SIDED|95.0|0.58|1.1|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.10|0.58|0.1612
70889885|NCT03779841|141265844|SUPERIORITY||Risk Ratio (RR)|1.04||||0.7789|TWO_SIDED|95.0|0.79|1.37|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.37|0.79|0.7789
70889886|NCT03779841|141265845|SUPERIORITY|||||||0.2972|||||||stratified Wilcoxon (Van Elteren)|||P-value is obtained from stratified Wilcoxon (Van Elteren) test versus Placebo with type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years) as stratification factors.||||0.2972
70889887|NCT03779841|141265845|SUPERIORITY|||||||0.8722|||||||stratified Wilcoxon (Van Elteren)|||P-value is obtained from stratified Wilcoxon (Van Elteren) test versus Placebo with type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years) as stratification factors.||||0.8722
70889888|NCT03779841|141265846|SUPERIORITY||Risk Ratio (RR)|0.99||||0.9814|TWO_SIDED|95.0|0.5|1.96|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.96|0.50|0.9814
70889889|NCT03779841|141265846|SUPERIORITY||Risk Ratio (RR)|0.99||||0.9715|TWO_SIDED|95.0|0.5|1.97|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.97|0.50|0.9715
70889890|NCT03779841|141265847|SUPERIORITY|||||||0.1281|||||||Log Rank|||P-value is from stratified log-rank test versus Placebo with type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years) as stratification factors.||||0.1281
70889891|NCT03779841|141265847|SUPERIORITY|||||||0.882|||||||Log Rank|||P-value is from stratified log-rank test versus Placebo with type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years) as stratification factors.||||0.8820
70889892|NCT03779841|141265848|SUPERIORITY||Risk Ratio (RR)|0.79||||0.1623|TWO_SIDED|95.0|0.57|1.1|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.10|0.57|0.1623
70889893|NCT03779841|141265848|SUPERIORITY||Risk Ratio (RR)|1.04||||0.7776|TWO_SIDED|95.0|0.78|1.39|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.39|0.78|0.7776
70889894|NCT03779841|141265849|SUPERIORITY||Risk Ratio (RR)|0.79||||0.1603|TWO_SIDED|95.0|0.56|1.1|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.10|0.56|0.1603
70889895|NCT03779841|141265849|SUPERIORITY||Risk Ratio (RR)|1.06||||0.6706|TWO_SIDED|95.0|0.8|1.42|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.42|0.80|0.6706
70889896|NCT03779841|141265850|SUPERIORITY||Risk Ratio (RR)|0.78||||0.1583|TWO_SIDED|95.0|0.55|1.1|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.10|0.55|0.1583
70889897|NCT03779841|141265850|SUPERIORITY||Risk Ratio (RR)|1.07||||0.6694|TWO_SIDED|95.0|0.8|1.43|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.43|0.80|0.6694
70889898|NCT03779841|141265851|SUPERIORITY||Risk Ratio (RR)|0.81||||0.2578|TWO_SIDED|95.0|0.55|1.18|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.18|0.55|0.2578
70889899|NCT03779841|141265851|SUPERIORITY||Risk Ratio (RR)|1.05||||0.7526|TWO_SIDED|95.0|0.76|1.47|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.47|0.76|0.7526
70889900|NCT03779841|141265852|SUPERIORITY||Risk Ratio (RR)|0.8||||0.2549|TWO_SIDED|95.0|0.55|1.18|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.18|0.55|0.2549
70889901|NCT03779841|141265852|SUPERIORITY||Risk Ratio (RR)|1.03||||0.8544|TWO_SIDED|95.0|0.73|1.45|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.45|0.73|0.8544
70889902|NCT03779841|141265853|SUPERIORITY||Risk Ratio (RR)|0.74||||0.1718|TWO_SIDED|95.0|0.48|1.14|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.14|0.48|0.1718
70889903|NCT03779841|141265853|SUPERIORITY||Risk Ratio (RR)|0.83||||0.3801|TWO_SIDED|95.0|0.54|1.27|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.27|0.54|0.3801
70889904|NCT03779841|141265854|SUPERIORITY||Risk Ratio (RR)|0.87||||0.5531|TWO_SIDED|95.0|0.54|1.39|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.39|0.54|0.5531
70889905|NCT03779841|141265854|SUPERIORITY||Risk Ratio (RR)|0.82||||0.4213|TWO_SIDED|95.0|0.51|1.33|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.33|0.51|0.4213
70889906|NCT03779841|141265855|SUPERIORITY||Risk Ratio (RR)|0.92||||0.804|TWO_SIDED|95.0|0.49|1.73|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.73|0.49|0.8040
70889907|NCT03779841|141265855|SUPERIORITY||Risk Ratio (RR)|1.1||||0.7573|TWO_SIDED|95.0|0.61|1.98|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.98|0.61|0.7573
70889908|NCT03779841|141265856|SUPERIORITY||Risk Ratio (RR)|0.69||||0.4065|TWO_SIDED|95.0|0.28|1.67|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.67|0.28|0.4065
70889909|NCT03779841|141265856|SUPERIORITY||Risk Ratio (RR)|1.28||||0.5257|TWO_SIDED|95.0|0.6|2.7|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||2.70|0.60|0.5257
70889910|NCT03779841|141265857|SUPERIORITY||Risk Ratio (RR)|0.78||||0.1612|TWO_SIDED|95.0|0.55|1.11|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.11|0.55|0.1612
70889911|NCT03779841|141265857|SUPERIORITY||Risk Ratio (RR)|1.0||||0.9966|TWO_SIDED|95.0|0.74|1.35|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.35|0.74|0.9966
70889912|NCT03779841|141265858|SUPERIORITY||Risk Ratio (RR)|0.68||||0.3374|TWO_SIDED|95.0|0.3|1.52|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.52|0.30|0.3374
70889913|NCT03779841|141265858|SUPERIORITY||Risk Ratio (RR)|1.23||||0.5403|TWO_SIDED|95.0|0.62|2.45|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||2.45|0.62|0.5403
70889914|NCT03779841|141265859|SUPERIORITY||Risk Ratio (RR)|3.94||||0.0163|TWO_SIDED|95.0|1.16|13.42|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||13.42|1.16|0.0163
70889915|NCT03779841|141265859|SUPERIORITY||Risk Ratio (RR)|2.7||||0.1101|TWO_SIDED|95.0|0.76|9.64|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||9.64|0.76|0.1101
70889916|NCT03779841|141265860|SUPERIORITY||Risk Ratio (RR)|0.86||||0.3339|TWO_SIDED|95.0|0.64|1.16|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.16|0.64|0.3339
70889917|NCT03779841|141265860|SUPERIORITY||Risk Ratio (RR)|1.1||||0.4614|TWO_SIDED|95.0|0.85|1.42|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.42|0.85|0.4614
70889918|NCT03483623|141265890|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
70889919|NCT03483623|141265891|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
70889920|NCT03483623|141265892|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
70889921|NCT03483623|141265893|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
70889922|NCT03483623|141265894|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
70889923|NCT03483623|141265895|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
70889924|NCT03483623|141265896|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
70889925|NCT03483623|141265897|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
70889926|NCT02199691|141265907|NON_INFERIORITY|95% confidence interval (CI) of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|9.2|||||TWO_SIDED|95.0|3.4|15.0||||||Serogroup A||15|3.4|
70889927|NCT02199691|141265907|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|24.6|||||TWO_SIDED|95.0|20.3|29.0||||||Serogroup C||29|20.3|
70889928|NCT02199691|141265907|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|16.2|||||TWO_SIDED|95.0|12.3|20.2||||||||20.2|12.3|
70889929|NCT02199691|141265907|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|19.6|||||TWO_SIDED|95.0|14.2|24.8||||||Serogroup W||24.8|14.2|
70889930|NCT02199691|141265908|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|5.0|||||TWO_SIDED|95.0|-0.8|10.5||||||Serogroup A||10.5|-0.8|
70889931|NCT02199691|141265908|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-2.5|2.4||||||Serogroup C||2.4|-2.5|
70889932|NCT02199691|141265908|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|-1.4|||||TWO_SIDED|95.0|-4.3|1.2||||||Serogroup Y||1.2|-4.3|
70889933|NCT02199691|141265908|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|-2.3|||||TWO_SIDED|95.0|-7.3|2.6||||||Serogroup W||2.6|-7.3|
70889934|NCT02199691|141265909|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio was \>2/3.|Geometric Mean Ratio|0.845|||||TWO_SIDED|95.0|0.722|0.99||||||PT: Geometric Mean Ratio||0.99|0.722|
70889935|NCT02199691|141265909|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio was \>2/3.|Geometric Mean Ratio|0.746|||||TWO_SIDED|95.0|0.661|0.842||||||FHA: Geometric Mean Ratio||0.842|0.661|
70889936|NCT02199691|141265909|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio was \>2/3.|Geometric Mean Ratio|0.753|||||TWO_SIDED|95.0|0.627|0.903||||||PRN: Geometric Mean Ratio||0.903|0.627|
70889937|NCT02199691|141265909|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio was \>2/3.|Geometric Mean Ratio|0.679|||||TWO_SIDED|95.0|0.525|0.878||||||FIM: Geometric Mean Ratio||0.878|0.525|
70889938|NCT02199691|141265910|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|-1.1|||||TWO_SIDED|95.0|-3.3|1.3||||||Serogroup Diphtheria||1.3|-3.3|
70889939|NCT02199691|141265910|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|0.1|||||TWO_SIDED|95.0|-1.2|1.9||||||Serogroup Tetanus||1.9|-1.2|
70889940|NCT02199691|141265911|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|1.8|||||TWO_SIDED|95.0|-1.8|6.3||||||HPV Type 6||6.3|-1.8|
70889941|NCT02199691|141265911|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|0.8|||||TWO_SIDED|95.0|-1.3|3.9||||||HPV Type 11||3.9|-1.3|
70889942|NCT02199691|141265911|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|0.4|||||TWO_SIDED|95.0|-1.9|3.6||||||HPV Type 16||3.6|-1.9|
70889943|NCT02199691|141265911|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|0.4|||||TWO_SIDED|95.0|-1.9|3.6||||||HPV Type 18||3.6|-1.9|
70889944|NCT02276495|141265915|SUPERIORITY|||||||0.668|||||||Kruskal-Wallis|||||||0.668
70889945|NCT02276495|141265916|SUPERIORITY|||||||0.006|||||||Kruskal-Wallis|||||||0.006
70889946|NCT02276495|141265917|SUPERIORITY|||||||0.013|||||||Kruskal-Wallis|||||||0.013
70889947|NCT03403634|141265939|SUPERIORITY|||||||0.046||||||significance level = 0.05|t-test, 1 sided|df = 11. one-sided as post treatment increases were of interest. the fold changes were log-transformed prior to inferences.||||||0.046
70889948|NCT01040871|141265993|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.038||||0.915|TWO_SIDED|95.0|0.529|2.037|||Cochran-Mantel-Haenszel|Stratified by IPI score|Odds ratio: VR-CAP CR rate relative to R-CHOP CR rate|||2.037|0.529|0.915
70889949|NCT02451748|141266001|EQUIVALENCE|ANOVA||||||0.5378||||||Tukey adjustment for multiple comparisons|ANOVA|A priori threshold was \<0.05.||The mean mRNA expression for IL-7 was compared between all three visits simultaneously in RA Peripheral Blood Nonnuclear Cells. The comparison between the first and second visit is as follows.||||0.5378
70889950|NCT02451748|141266001|EQUIVALENCE|ANOVA||||||0.919||||||Tukey adjustment for multiple comparisons|ANOVA|A priori threshold was \<0.05.||The mean mRNA expression for IL-7 was compared between all three visits simultaneously in RA Peripheral Blood Nonnuclear Cells. The comparison between the first and third visit is as follows.||||0.919
70889951|NCT02451748|141266001|EQUIVALENCE|ANOVA||||||0.4255||||||Tukey adjustment for multiple comparisons|ANOVA|A priori threshold was \<0.05.||The mean mRNA expression for IL-7 was compared between all three visits simultaneously in RA Peripheral Blood Nonnuclear Cells. The comparison between the second and third visit is as follows.||||0.4255
70889952|NCT02451748|141266001|EQUIVALENCE|ANOVA||||||0.1037||||||Tukey adjustment for multiple comparisons|ANOVA|A priori threshold was \<0.05.||The mean mRNA expression for IL-7R was compared between all three visits simultaneously in RA Peripheral Blood Nonnuclear Cells. The comparison between the first and second visit is as follows.||||0.1037
70889953|NCT02451748|141266001|EQUIVALENCE|ANOVA||||||0.0008||||||Tukey adjustment for multiple comparisons|ANOVA|A priori threshold was \<0.05.||The mean mRNA expression for IL-7R was compared between all three visits simultaneously in RA Peripheral Blood Nonnuclear Cells. The comparison between the first and third visit is as follows.||||0.0008
70889954|NCT02451748|141266001|EQUIVALENCE|ANOVA||||||0.0001||||||Tukey adjustment for multiple comparisons|ANOVA|A priori threshold was \<0.05.||The mean mRNA expression for IL-7R was compared between all three visits simultaneously in RA Peripheral Blood Nonnuclear Cells. The comparison between the second and third visit is as follows.||||0.0001
70889955|NCT00673049|141266015|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.091||||0.35|TWO_SIDED|95.0|0.909|1.31||One-sided significance level at alpha=0.024 was used. Two-sided p-value was reported.|Log Rank|Nominal p-values were reported without adjustment for the interim analysis.||P-value was calculated using log-rank test stratified by gender (Male or Female), Eastern Cooperative Oncology Group (ECOG) performance status (less than or equal to \[=\<1\] or 2), and region (United States/Canada, European Union, rest of world). The stratified Cox proportional hazards model was fitted to estimate the hazard ratio, using the same stratification variables as above.||1.310|0.909|0.35
70889956|NCT00673049|141266016|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.075||||0.426|TWO_SIDED|95.0|0.898|1.287||One-sided significance level at alpha=0.001 was used. Two-sided p-value was reported.|Log Rank|||P-value was calculated using log-rank test stratified by gender (Male or Female), ECOG performance status (less than or equal to \[=\<1\] or 2), and region (United States/Canada, European Union, rest of world). The stratified Cox proportional hazards model was fitted to estimate the hazard ratio, using the same stratification variables as above.||1.287|0.898|0.426
70889957|NCT00673049|141266017|SUPERIORITY_OR_OTHER||Difference in response rates|1.668||||0.338|TWO_SIDED|95.0|-1.7|5.1|||Chi-squared|||||5.1|-1.7|0.338
70889958|NCT01175824|141266025|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the upper limit of the 95% confidence interval (CI) of the difference in the LS mean between the two treatment arms (twice-daily insulin lispro Low Mixture minus the comparator arm) at 24 weeks is \<0.4%.|LS mean difference|-0.21|||||TWO_SIDED|95.0|-0.38|-0.04||||||||-0.04|-0.38|
70889959|NCT01175824|141266026|SUPERIORITY_OR_OTHER|||||||0.1858||95.0|||||Mixed Models Analysis|||||||0.1858
70889960|NCT01175824|141266027|SUPERIORITY_OR_OTHER|||||||0.3588||95.0||||HbA1c concentration \<7%|Fisher Exact|||||||0.3588
70889961|NCT01175824|141266027|SUPERIORITY_OR_OTHER|||||||0.5958||95.0||||HbA1c \<=6.5%|Fisher Exact|||||||0.5958
70889962|NCT01175824|141266028|SUPERIORITY_OR_OTHER|||||||0.0827||95.0||||p-value is for the Week 12 comparison|Mixed Models Analysis|||||||0.0827
70889963|NCT01175824|141266028|SUPERIORITY_OR_OTHER|||||||0.5353||95.0||||p-value is for the Week 24 comparison|Mixed Models Analysis|||||||0.5353
70889964|NCT01175824|141266032|SUPERIORITY_OR_OTHER|||||||0.2833||95.0||||p-value is for the comparison at Week 12.|Mixed Models Analysis|||||||0.2833
70889965|NCT01175824|141266032|SUPERIORITY_OR_OTHER|||||||0.0176||95.0||||p-value is for the comparison at Week 24.|Mixed Models Analysis|||||||0.0176
70889966|NCT01175824|141266038|SUPERIORITY_OR_OTHER||LS mean difference|-0.22|||||TWO_SIDED|95.0|-0.39|-0.05||||Superiority will be concluded if of 95% CI upper limit for treatment difference (2x-daily insulin lispro LM minus the comparator arm) at 24 wks is \<0%||||-0.05|-0.39|
70889967|NCT00924950|141266039|SUPERIORITY||Mean Difference (Final Values)|0.8571||||0.0008|TWO_SIDED||||||t-test, 2 sided|||||||0.0008
70889968|NCT02979535|141266041|OTHER||GMT ratio|0.947|||||TWO_SIDED|95.0|0.773|1.16||||||Antigen HPV-16||1.16|0.773|
70889969|NCT02979535|141266041|OTHER||GMT ratio|0.986|||||TWO_SIDED|95.0|0.803|1.21||||||Antigen HPV-18||1.21|0.803|
70889970|NCT02979535|141266042|OTHER||GMT ratio|0.977|||||TWO_SIDED|95.0|0.653|1.46||||||Dengue Virus Serotype 1||1.46|0.653|
70889971|NCT02979535|141266042|OTHER||GMT ratio|0.911|||||TWO_SIDED|95.0|0.654|1.27||||||Dengue Virus Serotype 2||1.27|0.654|
70889972|NCT02979535|141266042|OTHER||GMT ratio|0.921|||||TWO_SIDED|95.0|0.727|1.17||||||Dengue Virus Serotype 3||1.17|0.727|
70889973|NCT02979535|141266042|OTHER||GMT ratio|0.931|||||TWO_SIDED|95.0|0.733|1.18||||||Dengue Virus Serotype 4||1.18|0.733|
70889974|NCT01282710|141266069|SUPERIORITY_OR_OTHER|||||||0.04627||95.0|||||Mixed Models Analysis|||"Agreement between SureCALL® and IUPC Contraction Peak Events~Null hypothesis: the mean peak difference between TOCO and IUPC is equal to 0. Alternative hypothesis: the mean peak difference is not equal to 0."||||.04627
70889975|NCT01282710|141266069|SUPERIORITY_OR_OTHER|||||||0.1676||95.0|||||Mixed Models Analysis|||"Agreement between TOCO and IUPC Contraction Peak Events~Null hypothesis: the mean peak difference between TOCO and IUPC is equal to 0. Alternative hypothesis: the mean peak difference is not equal to 0."||||0.1676
70889976|NCT00009737|141266070|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested by comparing the upper limit of the 95% confidence interval for the hazard ratio to the non-inferiority margin of 1.25 in a first step, and then of 1.20 in a second step.|Hazard Ratio (HR)|0.87||||0.053|TWO_SIDED|95.0|0.75|1.0||For difference between arms, \< 0.001 for non-inferiority|Wald Chi-Square Test|||||1.00|0.75|0.053
70889977|NCT00009737|141266071|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested by comparing the upper limit of the 95% confidence interval for the hazard ratio to the non-inferiority margin of 1.25|Hazard Ratio (HR)|0.86||||0.041|TWO_SIDED|95.0|0.74|0.99||For difference between arms, \< 0.001 for non-inferiority|Wald Chi-Square Test|||||0.99|0.74|0.041
70889978|NCT00009737|141266072|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested by comparing the upper limit of the 95% confidence interval for the hazard ratio to the non-inferiority margin of 1.25|Hazard Ratio (HR)|0.84||||0.071|TWO_SIDED|95.0|0.69|1.01||For difference between arms, \< 0.001 for non-inferiority|Wald Chi-Square Test|||||1.01|0.69|0.071
70889979|NCT01807585|141266076|NON_INFERIORITY|Non-inferiority was determined by the application of a Z-test with a 10% non-inferiority margin as well as examination of confidence intervals.|Risk Difference (RD)|3.5|||<|0.0001|TWO_SIDED|95.0|-0.7|7.6|||One tailed Z-test|||Last Observation Carried Forward (LOCF)||7.6|-0.7|<0.0001
70889980|NCT01163682|141266079|NON_INFERIORITY|"This tests determined the odds of an increase of greater than or equal to 2 points on the BPI-SF worst pain score, from baseline to 16 weeks, among those in the intervention arm (electo-acupuncture), compared to those in the control arm (sham acupuncture). This change was considered to be clinically meaningful.~Null Hypothesis: electro-acupucture does not prevent taxane-induced peripheral neuropathy"|Odds Ratio (OR)|1.16||||0.25|TWO_SIDED|95.0|0.9|1.5|||Regression, Logistic|||||1.50|0.90|0.25
70889981|NCT01163682|141266080|NON_INFERIORITY|This tests determined the odds of an increase of greater than or equal to 5 points on the FACT-NTX scale, from baseline to 16 weeks, among those in the intervention arm (electo-acupuncture), compared to those in the control arm (sham acupuncture). This change was considered to be clinically meaningful.|Odds Ratio (OR)|1.25||||0.09|TWO_SIDED|95.0|0.97|1.62|||Regression, Logistic|||||1.62|0.97|0.09
70889982|NCT02504645|141266082|SUPERIORITY|||||||0.2631|TWO_SIDED|0.0|||||Chi-squared|||||||0.2631
70889983|NCT00359762|141266089|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority test was based on the upper 1-sided 97.5% CI for the hazard ratio of Exenatide/Glimepiride;the upper bound was compared to 1.25: if \<1.25, the hypothesis that the risk of treatment failure with Exenatide is more than 1.25 times greater than the risk with Glimepiride is rejected.Superiority test was based on the 2-sided 95% CI for the hazard ratio. If CI excludes 1, the hypothesis that the risk of treatment failure with Exenatide is equal to that with Glimepiride is rejected.|Hazard Ratio|0.748||||0.002|TWO_SIDED|95.0|0.623|0.899|||Regression, Cox|Time to treatment failure was modeled using Cox regression with treatment and baseline HbA1c as predictive terms.||The null hypothesis (H0) and alternative hypothesis (H1) for the primary analysis (i.e., non-inferiority) are:H0: hazards of treatment for Exenatide/hazards of treatment for Glimepiride \>=1.25.H1: hazards of treatment for Exenatide/hazards of treatment for Glimepiride \< 1.25. With 527 patients in each arm, the study would have approximately 90% power to conclude non-inferiority of Exenatide to Glimepiride.||0.899|0.623|0.0020
70889984|NCT00359762|141266090|SUPERIORITY_OR_OTHER|||||||0.0315|TWO_SIDED|99.95|||||Log Rank|||Kaplan-Meier survival curves for time to treatment failure were compared between treatment groups using log rank test.||||0.0315
70889985|NCT00359762|141266091|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.66|STANDARD_ERROR_OF_MEAN|5.56||0.7648|TWO_SIDED|95.0|-12.58|9.25|||Mixed Models Analysis|||Mixed-model Repeated Measures (MMRM) analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||9.25|-12.58|0.7648
70889986|NCT00359762|141266092|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-14.35|STANDARD_ERROR_OF_MEAN|7.399||0.0528|TWO_SIDED|95.0|-28.88|0.17|||ANCOVA|||Change in HOMA-B from baseline to endpoint was analyzed by an analysis of covariance (ANCOVA) model that includes treatment and baseline HbA1c stratum (\<=7.3%, \>7.3% to \<=8.2%, \>8.2%) as factors and baseline value as a covariate.||0.17|-28.88|0.0528
70889987|NCT00359762|141266093|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.032||0.904|TWO_SIDED|95.0|-0.07|0.06|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||0.06|-0.07|0.9040
70889988|NCT00359762|141266094|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.017||0.25|TWO_SIDED|95.0|-0.05|0.01|||ANCOVA|||Change in fasting proinsulin/insulin ratio from baseline to endpoint was analyzed by an ANCOVA model that includes treatment and baseline HbA1c stratum (\<=7.3%, \>7.3% to \<=8.2%, \>8.2%) as factors and baseline value as a covariate.||0.01|-0.05|0.2500
70889989|NCT00359762|141266095|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|4.497||0.9001|TWO_SIDED|95.0|-9.4|8.27|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||8.27|-9.40|0.9001
70889990|NCT00359762|141266096|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|11.19|STANDARD_ERROR_OF_MEAN|4.966||0.0246|TWO_SIDED|95.0|1.44|20.95|||ANCOVA|||Change in DI30/DG30 ratio from baseline to endpoint was analyzed by an ANCOVA model that includes treatment and baseline HbA1c stratum (\<=7.3%, \>7.3% to \<=8.2%, \>8.2%) as factors and baseline value as a covariate.||20.95|1.44|0.0246
70889991|NCT00359762|141266097|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.67|STANDARD_ERROR_OF_MEAN|1.598||0.0036|TWO_SIDED|95.0|1.53|7.81|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||7.81|1.53|0.0036
70889992|NCT00359762|141266098|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|7.33|STANDARD_ERROR_OF_MEAN|2.128||0.0006|TWO_SIDED|95.0|3.15|11.5|||ANCOVA|||Change in disposition index from baseline to endpoint was analyzed by an ANCOVA model that includes treatment and baseline HbA1c stratum (\<=7.3%, \>7.3% to \<=8.2%, \>8.2%) as factors and baseline value as a covariate.||11.50|3.15|0.0006
70889993|NCT00359762|141266099|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.07||0.0128|TWO_SIDED|95.0|-0.31|-0.04|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||-0.04|-0.31|0.0128
70889994|NCT00359762|141266100|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.05||0.0015|TWO_SIDED|95.0|-0.26|-0.06|||ANCOVA|||Change in HbA1c from baseline to endpoint was analyzed by an ANCOVA model that includes treatment as factor and baseline value as a covariate.||-0.06|-0.26|0.0015
70889995|NCT00359762|141266101|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.174|<|0.0001|TWO_SIDED|95.0|-1.03|-0.34|||Mixed Models Analysis|||MMRM includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||-0.34|-1.03|<.0001
70889996|NCT00359762|141266102|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.183||0.0109|TWO_SIDED|95.0|-0.83|-0.11|||ANCOVA|||Change in fasting plasma glucose from baseline to endpoint was analyzed by an ANCOVA model that includes treatment and baseline HbA1c stratum (\<=7.3%, \>7.3% to \<=8.2%, \>8.2%) as factors and baseline value as a covariate.||-0.11|-0.83|0.0109
70889997|NCT00359762|141266103|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.424|<|0.0001|TWO_SIDED|95.0|-3.64|-1.97|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||-1.97|-3.64|<.0001
70889998|NCT00359762|141266104|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.19|STANDARD_ERROR_OF_MEAN|0.327|<|0.0001|TWO_SIDED|95.0|-2.84|-1.55|||ANCOVA|||Change in postprandial (2 hours) plasma glucose from baseline to endpoint was analyzed by an ANCOVA model that includes treatment and baseline HbA1c stratum (\<=7.3%, \>7.3% to \<=8.2%, \>8.2%) as factors and baseline value as a covariate.||-1.55|-2.84|<.0001
70889999|NCT00359762|141266105|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.4|STANDARD_ERROR_OF_MEAN|0.463|<|0.0001|TWO_SIDED|95.0|-6.31|-4.49|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction and baseline value as a covariate. The unstructured covariance matrix was used.||-4.49|-6.31|<.0001
70890000|NCT00359762|141266106|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|1.228|<|0.0001|TWO_SIDED|95.0|-7.61|-2.79|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||-2.79|-7.61|<.0001
70890001|NCT00359762|141266107|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.71|STANDARD_ERROR_OF_MEAN|0.75||0.0228|TWO_SIDED|95.0|-3.18|-0.24|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||-0.24|-3.18|0.0228
70890002|NCT00359762|141266108|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.805||0.3737|TWO_SIDED|95.0|-2.3|0.86|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and visit by treatment interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||0.86|-2.30|0.3737
70890003|NCT00359762|141266109|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.089||0.0042|TWO_SIDED|95.0|-0.43|-0.08|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||-0.08|-0.43|0.0042
70890004|NCT00359762|141266110|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.079||0.7914|TWO_SIDED|95.0|-0.13|0.18|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||0.18|-0.13|0.7914
70890005|NCT00359762|141266111|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.019||0.0011|TWO_SIDED|95.0|0.02|0.1|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||0.10|0.02|0.0011
70890006|NCT00359762|141266112|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|0.22|0.37|||Negative Binomial Model|||The number of hypoglycemic episodes by patient were compared between treatment groups using a negative binomial model with effects for treatment and baseline HbA1c and the logarithm of the days of exposure as the offset variable.||0.37|0.22|<.0001
70890007|NCT00359762|141266113|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|0.141||0.0508|TWO_SIDED|95.0|0.0|0.55|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value at Period III as a covariate. The compound symmetric covariance structure was assumed.||0.55|-0.00|0.0508
70890008|NCT02652780|141266119|SUPERIORITY||Mean Difference (Net)|-0.008||||0.8783|TWO_SIDED|95.0|-0.119|0.102|||ANCOVA|||A mixed model of analysis of covariance (ANCOVA) was used with change from baseline at Week 48 as the response, and participants, eyes of the participant as random factor, treatment and baseline LogMAR value as covariates in the model. P-value is used to assess the significance of the difference between All-GS010 and All-Sham with respect to change of LogMAR from baseline.||0.102|-0.119|0.8783
70890009|NCT01172938|141266131|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|19.0||||0.0001|TWO_SIDED|95.0|9.7|28.3|||Cochran-Mantel-Haenszel|2-sided p-value is based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline disease modifying antirheumatic drug (DMARD) use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% confidence interval (CI) is based on a normal approximation to the weighted average.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||28.3|9.7|0.0001
70890010|NCT01172938|141266131|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|11.3||||0.0166|TWO_SIDED|95.0|2.2|20.4|||Cochran-Mantel-Haenszel|2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||20.4|2.2|0.0166
70890011|NCT01172938|141266132|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.159||||0.0017|TWO_SIDED|95.0|-0.258|-0.06|||ANCOVA|Based on an ANCOVA model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.060|-0.258|0.0017
70890012|NCT01172938|141266132|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.113||||0.0252|TWO_SIDED|95.0|-0.211|-0.014|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.014|-0.211|0.0252
70890013|NCT01172938|141266133|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|22.2|||<|0.0001|TWO_SIDED|95.0|13.4|30.9||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||30.9|13.4|<0.0001
70890014|NCT01172938|141266133|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|12.4||||0.0038|TWO_SIDED|95.0|4.2|20.7||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||20.7|4.2|0.0038
70890015|NCT01172938|141266134|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.182||||0.0005|TWO_SIDED|95.0|-0.283|-0.08||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.080|-0.283|0.0005
70890016|NCT01172938|141266134|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.135||||0.0091|TWO_SIDED|95.0|-0.236|-0.034||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.034|-0.236|0.0091
70890017|NCT01172938|141266135|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.42||||0.0056|TWO_SIDED|95.0|0.71|4.13||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||4.13|0.71|0.0056
70890018|NCT01172938|141266135|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.7||||0.0504|TWO_SIDED|95.0|0.0|3.4||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||3.40|-0.00|0.0504
70890019|NCT01172938|141266136|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|16.7||||0.0017|TWO_SIDED|95.0|6.6|26.8||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||26.8|6.6|0.0017
70890020|NCT01172938|141266136|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|8.9|||||TWO_SIDED|95.0|-1.2|18.9|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||18.9|-1.2|
70890021|NCT01172938|141266137|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.9||||0.0023|TWO_SIDED|95.0|-12.9|-2.8||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-2.8|-12.9|0.0023
70890022|NCT01172938|141266137|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.8|||||TWO_SIDED|95.0|-10.8|-0.7|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-0.7|-10.8|
70890023|NCT01172938|141266138|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|||||TWO_SIDED|95.0|-1.2|0.4|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.4|-1.2|
70890024|NCT01172938|141266138|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|||||TWO_SIDED|95.0|-1.3|0.3|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.3|-1.3|
70890025|NCT01172938|141266139|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|||||TWO_SIDED|95.0|-1.1|0.4|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.4|-1.1|
70890026|NCT01172938|141266139|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|||||TWO_SIDED|95.0|-1.3|0.3|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.3|-1.3|
70890027|NCT01172938|141266140|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.88|||||TWO_SIDED|95.0|-7.41|-2.34|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-2.34|-7.41|
70890028|NCT01172938|141266140|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.39|||||TWO_SIDED|95.0|-6.92|-1.86|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-1.86|-6.92|
70890029|NCT01172938|141266141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|||||TWO_SIDED|95.0|-0.76|-0.31|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-0.31|-0.76|
70890030|NCT01172938|141266141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|||||TWO_SIDED|95.0|-0.7|-0.25|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-0.25|-0.70|
70890031|NCT01172938|141266142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.33|||||TWO_SIDED|95.0|0.43|4.23|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||4.23|0.43|
70890032|NCT01172938|141266142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|||||TWO_SIDED|95.0|-1.77|2.03|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||2.03|-1.77|
70890033|NCT01172938|141266143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.56|||||TWO_SIDED|95.0|1.72|5.4|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||5.40|1.72|
70890034|NCT01172938|141266143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.04|||||TWO_SIDED|95.0|0.21|3.88|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||3.88|0.21|
70890035|NCT01172938|141266144|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|24.6|||||TWO_SIDED|95.0|15.2|34.0|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||34.0|15.2|
70890036|NCT01172938|141266144|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|12.4|||||TWO_SIDED|95.0|3.4|21.5|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||21.5|3.4|
70890037|NCT01172938|141266145|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|-10.6|||||TWO_SIDED|95.0|-15.4|-5.7|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-5.7|-15.4|
70890038|NCT01172938|141266145|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.1|||||TWO_SIDED|95.0|-12.0|-2.2|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-2.2|-12.0|
70890039|NCT01172938|141266146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|||||TWO_SIDED|95.0|-1.6|0.0|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.0|-1.6|
70890040|NCT01172938|141266146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean DIfference|-0.8|||||TWO_SIDED|95.0|-1.6|0.1|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.1|-1.6|
70890041|NCT01172938|141266147|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|||||TWO_SIDED|95.0|-1.2|0.3|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.3|-1.2|
70890042|NCT01172938|141266147|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|||||TWO_SIDED|95.0|-1.5|0.1|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.1|-1.5|
70890043|NCT01172938|141266148|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-6.38|||||TWO_SIDED|95.0|-9.0|-3.75|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-3.75|-9.00|
70890044|NCT01172938|141266148|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-4.41|||||TWO_SIDED|95.0|-7.03|-1.79|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-1.79|-7.03|
70890045|NCT01172938|141266149|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|||||TWO_SIDED|95.0|-0.94|-0.46|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-0.46|-0.94|
70890046|NCT01172938|141266149|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|||||TWO_SIDED|95.0|-0.7|-0.22|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-0.22|-0.70|
70890047|NCT01172938|141266150|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|2.21|||||TWO_SIDED|95.0|0.32|4.1|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||4.10|0.32|
70890048|NCT01172938|141266150|SUPERIORITY_OR_OTHER_LEGACY||LS Mean DIfference|0.4|||||TWO_SIDED|95.0|-1.5|2.29|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||2.29|-1.50|
70890049|NCT01172938|141266151|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|3.3|||||TWO_SIDED|95.0|-10.1|16.7|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||16.7|-10.1|
70890050|NCT01172938|141266151|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|7.3|||||TWO_SIDED|95.0|-6.5|21.1|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||21.1|-6.5|
70890051|NCT01172938|141266152|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|2.9|||||TWO_SIDED|95.0|-13.4|19.3|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||19.3|-13.4|
70890052|NCT01172938|141266152|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|7.7|||||TWO_SIDED|95.0|-9.1|24.6|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||24.6|-9.1|
70890053|NCT01172938|141266153|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|19.2|||||TWO_SIDED|95.0|9.0|29.3|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||29.3|9.0|
70890054|NCT01172938|141266153|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|16.6|||||TWO_SIDED|95.0|6.4|26.8|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||26.8|6.4|
70890055|NCT01172938|141266154|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|13.2|||||TWO_SIDED|95.0|-0.1|26.5|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||26.5|-0.1|
70890056|NCT01172938|141266154|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|11.3|||||TWO_SIDED|95.0|-2.4|25.0|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||25.0|-2.4|
70890057|NCT01172938|141266155|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|8.9|||||TWO_SIDED|95.0|-6.8|24.6|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||24.6|-6.8|
70890058|NCT01172938|141266155|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|7.7|||||TWO_SIDED|95.0|-8.7|24.2|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||24.2|-8.7|
70890059|NCT01172938|141266156|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|26.3|||||TWO_SIDED|95.0|17.1|35.5|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||35.5|17.1|
70890060|NCT01172938|141266156|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|14.2|||||TWO_SIDED|95.0|5.4|23.1|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||23.1|5.4|
70890061|NCT01172938|141266157|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|10.3|||||TWO_SIDED|95.0|3.7|16.8|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||16.8|3.7|
70890062|NCT01172938|141266157|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|9.5|||||TWO_SIDED|95.0|3.0|16.0|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||16.0|3.0|
70890063|NCT01172938|141266158|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|3.1|||||TWO_SIDED|95.0|-0.4|6.5|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||6.5|-0.4|
70890064|NCT01172938|141266158|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|4.8|||||TWO_SIDED|95.0|0.8|8.7|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||8.7|0.8|
70890065|NCT01172938|141266159|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|14.9|||||TWO_SIDED|95.0|8.3|21.5|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||21.5|8.3|
70890066|NCT01172938|141266159|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|10.1|||||TWO_SIDED|95.0|4.0|16.1|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||16.1|4.0|
70890067|NCT01172938|141266160|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|9.5|||||TWO_SIDED|95.0|4.8|14.2|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||14.2|4.8|
70890068|NCT01172938|141266160|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|4.7|||||TWO_SIDED|95.0|1.2|8.3|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||8.3|1.2|
70890069|NCT01172938|141266161|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|7.6|||||TWO_SIDED|95.0|-2.8|17.9|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||17.9|-2.8|
70890070|NCT01172938|141266161|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|11.9|||||TWO_SIDED|95.0|0.8|23.0|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||23.0|0.8|
70890071|NCT01172938|141266162|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|-1.4|||||TWO_SIDED|95.0|-17.7|14.8|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||14.8|-17.7|
70890072|NCT01172938|141266162|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|2.4|||||TWO_SIDED|95.0|-14.8|19.6|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||19.6|-14.8|
70890073|NCT01172938|141266163|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|17.4|||||TWO_SIDED|95.0|6.6|28.2|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||28.2|6.6|
70890074|NCT01172938|141266163|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|16.8|||||TWO_SIDED|95.0|5.6|27.9|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||27.9|5.6|
70890075|NCT01172938|141266164|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|5.8|||||TWO_SIDED|95.0|-10.7|22.4|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||22.4|-10.7|
70890076|NCT01172938|141266164|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|8.8|||||TWO_SIDED|95.0|-8.5|26.2|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||26.2|-8.5|
70890077|NCT04188041|141266187|OTHER|see above||||||0.02|||||||Wilcoxon signed rank test|||Non-parametric Wilcoxon signed rank test for paired data was used to test for significant change in confidence.||||0.02
70890078|NCT04808609|141266201|OTHER|feasibility test|Risk Ratio (RR)|1.27|STANDARD_ERROR_OF_MEAN|1.63||0.77|TWO_SIDED|95.0|0.24|6.76|||Fisher Exact|||||6.76|0.24|0.77
70890079|NCT04808609|141266202|OTHER|feasibility test|Risk Ratio (RR)|1.27|STANDARD_ERROR_OF_MEAN|0.84||0.66|TWO_SIDED|95.0|0.43|3.78|||Chi-squared|||||3.78|0.43|0.66
70890080|NCT04808609|141266203|OTHER|feasibility test|Cohen's D|0.21|STANDARD_ERROR_OF_MEAN|0.33||0.59|TWO_SIDED|95.0|-0.44|0.86|||t-test, 2 sided|||||0.86|-0.44|0.59
70890081|NCT04808609|141266203|OTHER|feasibility|Cohen's D|0.41|STANDARD_ERROR_OF_MEAN|0.17||0.02|TWO_SIDED|95.0|0.07|0.74|||t-test, 1 sided|||Results from Paired T-Test assessing the with-subject time effect on exhaled CO in ppm from baseline to 12 weeks||0.74|0.07|0.02
70890082|NCT04808609|141266204|OTHER|feasibility test|Cohen's D|0.16|STANDARD_ERROR_OF_MEAN|0.31||0.61|TWO_SIDED|95.0|-0.46|0.78|||t-test, 2 sided|||||0.78|-0.46|0.61
70890083|NCT04808609|141266205|OTHER|feasibility test|Cohen's D|0.19|STANDARD_ERROR_OF_MEAN|0.31||0.55|TWO_SIDED|95.0|-0.42|0.8|||t-test, 2 sided|||||0.80|-0.42|0.55
70890084|NCT04808609|141266206|OTHER|feasibility test|Cohen's D|0.004|STANDARD_ERROR_OF_MEAN|0.31||0.99|TWO_SIDED|95.0|-0.61|0.62|||t-test, 2 sided|||||0.62|-0.61|0.99
70890085|NCT04177693|141266232|SUPERIORITY|||||||0.112|||||||Kruskal-Wallis|||||||0.112
70890086|NCT04177693|141266233|SUPERIORITY|||||||0.613|||||||Kruskal-Wallis|||||||0.613
70890087|NCT04177693|141266234|SUPERIORITY|||||||0.202|||||||Kruskal-Wallis|||||||0.202
70890088|NCT04177693|141266235|SUPERIORITY|||||||0.508|||||||Kruskal-Wallis|||||||0.508
70890089|NCT04177693|141266236|SUPERIORITY|||||||0.237|||||||Kruskal-Wallis|||||||0.237
70890090|NCT04177693|141266237|SUPERIORITY|||||||0.327|||||||Kruskal-Wallis|||||||0.327
70890091|NCT04177693|141266238|SUPERIORITY|||||||0.633|||||||Kruskal-Wallis|||||||0.633
70890092|NCT04177693|141266239|SUPERIORITY|||||||0.146|||||||Kruskal-Wallis|||||||0.146
70890093|NCT04177693|141266240|SUPERIORITY|||||||0.372|||||||t-test, 2 sided|||||||0.372
70890094|NCT04177693|141266241|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
70890095|NCT04177693|141266242|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
70890096|NCT04382326|141266255|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-8.6|||||TWO_SIDED|95.0|-12.1|-5.1||||||Serotype 1: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-5.1|-12.1|
70890097|NCT04382326|141266255|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-15.5|||||TWO_SIDED|95.0|-20.1|-10.8||||||Serotype 3: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||-10.8|-20.1|
70890098|NCT04382326|141266255|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-8.4|||||TWO_SIDED|95.0|-12.0|-4.9||||||Serotype 4: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-4.9|-12.0|
70890099|NCT04382326|141266255|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-4.3|||||TWO_SIDED|95.0|-7.8|-0.8||||||Serotype 5: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-0.8|-7.8|
70890100|NCT04382326|141266255|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-2.4|||||TWO_SIDED|95.0|-4.6|-0.2||||||Serotype 6A: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-0.2|-4.6|
70890101|NCT04382326|141266255|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-4.1|||||TWO_SIDED|95.0|-7.0|-1.2||||||Serotype 6B: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-1.2|-7.0|
70890102|NCT04382326|141266255|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-1.0|||||TWO_SIDED|95.0|-2.7|0.7||||||Serotype 7F: 2-sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||0.7|-2.7|
70890103|NCT04382326|141266255|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-7.9|||||TWO_SIDED|95.0|-11.3|-4.6||||||Serotype 9V: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-4.6|-11.3|
70890104|NCT04382326|141266255|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-0.8|||||TWO_SIDED|95.0|-3.1|1.6||||||Serotype 14: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||1.6|-3.1|
70890105|NCT04382326|141266255|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-0.6|||||TWO_SIDED|95.0|-3.1|1.9||||||Serotype 18C: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||1.9|-3.1|
70890106|NCT04382326|141266255|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-1.0|||||TWO_SIDED|95.0|-2.6|0.5||||||Serotype 19A: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||0.5|-2.6|
70890107|NCT04382326|141266255|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|0.2|||||TWO_SIDED|95.0|-1.5|2.0||||||Serotype 19F: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||2.0|-1.5|
70890108|NCT04382326|141266255|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-7.6|||||TWO_SIDED|95.0|-11.4|-3.9||||||Serotype 23F: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-3.9|-11.4|
70890109|NCT04382326|141266255|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|11.2|||||TWO_SIDED|95.0|8.6|14.0||||||Serotype 8: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||14.0|8.6|
70890110|NCT04382326|141266255|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|-3.3|||||TWO_SIDED|95.0|-6.9|0.3||||||Serotype 10A: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||0.3|-6.9|
70890111|NCT04382326|141266255|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|7.1||||||95.0|4.2|10.2||||||Serotype 11A: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||10.2|4.2|
70890112|NCT04382326|141266255|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|-18.1|||||TWO_SIDED|95.0|-22.1|-14.0||||||Serotype 12F: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-14.0|-22.1|
70890113|NCT04382326|141266255|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|12.7|||||TWO_SIDED|95.0|10.2|15.4||||||Serotype 15B: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||15.4|10.2|
70890114|NCT04382326|141266255|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|12.8|||||TWO_SIDED|95.0|10.3|15.5||||||Serotype 22F: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||15.5|10.3|
70890115|NCT04382326|141266255|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|1.1|||||TWO_SIDED|95.0|-2.2|4.5||||||Serotype 33F: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||4.5|-2.2|
70890116|NCT04382326|141266256|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.69|||||TWO_SIDED|95.0|0.63|0.76||||||Serotype 1: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.76|0.63|
70890117|NCT04382326|141266256|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.66|||||TWO_SIDED|95.0|0.61|0.73||||||Serotype 3: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.73|0.61|
70890118|NCT04382326|141266256|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.78||||||95.0|0.7|0.86||||||Serotype 4: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.86|0.70|
70890119|NCT04382326|141266256|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.74|||||TWO_SIDED|95.0|0.67|0.82||||||Serotype 5: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.82|0.67|
70890120|NCT04382326|141266256|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.77|||||TWO_SIDED|95.0|0.7|0.85||||||Serotype 6A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.85|0.70|
70890121|NCT04382326|141266256|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.7|||||TWO_SIDED|95.0|0.62|0.79||||||Serotype 6B: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.79|0.62|
70890122|NCT04382326|141266256|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.76|||||TWO_SIDED|95.0|0.7|0.82||||||Serotype 7F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.82|0.70|
70890123|NCT04382326|141266256|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.8||||||95.0|0.73|0.88||||||Serotype 9V: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.88|0.73|
70890124|NCT04382326|141266256|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.9|||||TWO_SIDED|95.0|0.81|1.0||||||Serotype 14: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||1.00|0.81|
70890125|NCT04382326|141266256|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.74||||||95.0|0.67|0.82||||||Serotype 18C: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.82|0.67|
70890126|NCT04382326|141266256|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.85|||||TWO_SIDED|95.0|0.77|0.94||||||Serotype 19A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.94|0.77|
70890127|NCT04382326|141266256|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.86|||||TWO_SIDED|95.0|0.78|0.96||||||Serotype 19F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.96|0.78|
70890128|NCT04382326|141266256|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.64|||||TWO_SIDED|95.0|0.57|0.72||||||Serotype 23F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.72|0.57|
70890129|NCT04382326|141266256|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.87|||||TWO_SIDED|95.0|1.71|2.06||||||Serotype 8: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||2.06|1.71|
70890130|NCT04382326|141266256|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|2.94||||||95.0|2.64|3.26||||||Serotype 10A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||3.26|2.64|
70890131|NCT04382326|141266256|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.67|||||TWO_SIDED|95.0|1.51|1.84||||||Serotype 11A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||1.84|1.51|
70890132|NCT04382326|141266256|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.88||||||95.0|0.79|0.97||||||Serotype 12F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.97|0.79|
70890133|NCT04382326|141266256|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|5.95||||||95.0|5.39|6.55||||||Serotype 15B: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||6.55|5.39|
70890134|NCT04382326|141266256|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|5.01||||||95.0|4.54|5.52||||||Serotype 22F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||5.52|4.54|
70890135|NCT04382326|141266256|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|4.4|||||TWO_SIDED|95.0|3.99|4.85||||||Serotype 33F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||4.85|3.99|
70890136|NCT04382326|141266257|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|-4.3|||||TWO_SIDED|95.0|-7.5|-1.4||||||Diphtheria: 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||-1.4|-7.5|
70890137|NCT04382326|141266257|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.3|||||TWO_SIDED|95.0|-1.0|1.7||||||Tetanus: 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||1.7|-1.0|
70890138|NCT04382326|141266257|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|-0.2||||||95.0|-3.5|3.1||||||Pertussis (PT): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||3.1|-3.5|
70890139|NCT04382326|141266257|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.6||||||95.0|-2.5|3.9||||||Pertussis (FHA): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||3.9|-2.5|
70890140|NCT04382326|141266257|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|-1.3||||||95.0|-4.7|2.2||||||Pertussis (PRN): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.2-Sided CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||2.2|-4.7|
70890141|NCT04382326|141266257|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.0||||||95.0|-3.2|2.9||||||HBsAg: 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||2.9|-3.2|
70890142|NCT04382326|141266257|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.0||||||95.0|-3.4|3.2||||||Poliovirus (Type 1): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||3.2|-3.4|
70890143|NCT04382326|141266257|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.8||||||95.0|-2.4|4.6||||||Poliovirus (Type 2): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||4.6|-2.4|
70890144|NCT04382326|141266257|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.0||||||95.0|-3.2|3.1||||||Poliovirus (Type 3): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||3.1|-3.2|
70890145|NCT04382326|141266257|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0||||||Hib (≥0.15 μg/mL): 2-Sided CI were calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||3.0|-3.0|
70890146|NCT04382326|141266258|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratios|0.65|||||TWO_SIDED|95.0|0.59|0.72||||||Serotype 1: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.72|0.59|
70890147|NCT04382326|141266258|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.7|||||TWO_SIDED|95.0|0.64|0.76||||||Serotype 3: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.76|0.64|
70890148|NCT04382326|141266258|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.7||||||95.0|0.63|0.78||||||Serotype 4: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.78|0.63|
70890149|NCT04382326|141266258|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.69||||||95.0|0.61|0.77||||||Serotype 5: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.77|0.61|
70890150|NCT04382326|141266258|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.72||||||95.0|0.65|0.81||||||Serotype 6A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.81|0.65|
70890151|NCT04382326|141266258|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.6|||||TWO_SIDED|95.0|0.51|0.7||||||Serotype 6B: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.70|0.51|
70890152|NCT04382326|141266258|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.75||||||95.0|0.69|0.81||||||Serotype 7F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.81|0.69|
70890153|NCT04382326|141266258|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.72|||||TWO_SIDED|95.0|0.65|0.8||||||Serotype 9V: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.80|0.65|
70890154|NCT04382326|141266258|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.79||||||95.0|0.71|0.89||||||Serotype 14: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.89|0.71|
70890155|NCT04382326|141266258|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.77||||||95.0|0.7|0.84||||||Serotype 18C: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.84|0.70|
70890156|NCT04382326|141266258|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.79|||||TWO_SIDED|95.0|0.72|0.86||||||Serotype 19A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.86|0.72|
70890157|NCT04382326|141266258|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.79||||||95.0|0.73|0.86||||||Serotype 19F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.86|0.73|
70890158|NCT04382326|141266258|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.66|||||TWO_SIDED|95.0|0.58|0.75||||||Serotype 23F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.75|0.58|
70890159|NCT04382326|141266258|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.98||||||95.0|1.81|2.16||||||Serotype 8: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||2.16|1.81|
70890160|NCT04382326|141266258|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.32||||||95.0|1.18|1.49||||||Serotype 10A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||1.49|1.18|
70890161|NCT04382326|141266258|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.52||||||95.0|1.39|1.67||||||Serotype 11A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||1.67|1.39|
70890162|NCT04382326|141266258|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.6||||||95.0|0.54|0.67||||||Serotype 12F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.67|0.54|
70890163|NCT04382326|141266258|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|4.82|||||TWO_SIDED|95.0|4.39|5.3||||||Serotype 15B: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||5.30|4.39|
70890164|NCT04382326|141266258|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|4.06||||||95.0|3.68|4.48||||||Serotype 22F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||4.48|3.68|
70890165|NCT04382326|141266258|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.64||||||95.0|1.46|1.83||||||Serotype 33F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||1.83|1.46|
70890166|NCT04382326|141266266|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR of 20vPnC group to 13vPnC group is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratios|1.29||||||95.0|1.05|1.58||||||Measles: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - 13vPnC) of the logarithms of the concentrations and the corresponding CI (based on the Student's t distribution).||1.58|1.05|
70890167|NCT04382326|141266267|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR of 20vPnC group to 13vPnC group is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratios|1.08|||||TWO_SIDED|95.0|0.85|1.38||||||Mumps: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - 13vPnC) of the logarithms of the concentrations and the corresponding CI (based on the Student's t distribution).||1.38|0.85|
70890168|NCT04382326|141266268|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR of 20vPnC group to 13vPnC group is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratios|1.23|||||TWO_SIDED|95.0|1.02|1.48||||||Rubella: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - 13vPnC) of the logarithms of the concentrations and the corresponding CI (based on the Student's t distribution).||1.48|1.02|
70890169|NCT04382326|141266269|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR of 20vPnC group to 13vPnC group is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratios|0.99|||||TWO_SIDED|95.0|0.84|1.17||||||Varicella: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - 13vPnC) of the logarithms of the concentrations and the corresponding CI (based on the Student's t distribution)||1.17|0.84|
70890170|NCT03224468|141266291|SUPERIORITY|Power was determined to be 85.2% using a Monte Carlo simulation approach in which data were simulated from a multi-level linear regression model with a subject-varying random intercept, a shared baseline across WLC and MMC, and fixed effects for a change over each time point. Simulated data were fit with a linear model estimated via GEE - simulations were repeated 1000 times and power was estimated as the proportion where the contrast between WLC and MM had p\<0.05.|Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|0.15|0.4||The p-value is adjusted for multiple comparisons using per Benjamini \& Hochberg (1995) across the five primary outcome measures. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|Estimate is the mean difference in number of symptoms for MM above and beyond WLC (positive values denote higher number of symptoms for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's number of symptoms at baseline.||0.40|0.15|<0.001
70890171|NCT03224468|141266292|SUPERIORITY|Power was determined to be 83.6% using a Monte Carlo simulation approach in which data were simulated from a multi-level linear regression model with a subject-varying random intercept, a shared baseline across WLC and MMC, and fixed effects for a change over each time point. Simulated data were fit with a linear model estimated via GEE - simulations were repeated 1000 times and power was estimated as the proportion where the contrast between WLC and MM had p\<0.05.|Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.45||0.5|TWO_SIDED|95.0|-1.4|0.4||The p-value is adjusted for multiple comparisons using per Benjamini \& Hochberg (1995) across the five primary outcome measures. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|Estimate is the mean difference in scale score for MM above and beyond WLC (positive values denote higher score for MM).|The mean difference in scale scores between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's scale scores at baseline.||0.4|-1.4|0.50
70890172|NCT03224468|141266293|SUPERIORITY|Power was determined to be 84.3% using a Monte Carlo simulation approach in which data were simulated from a multi-level linear regression model with a subject-varying random intercept, a shared baseline across WLC and MMC, and fixed effects for a change over each time point. Simulated data were fit with a linear model estimated via GEE - simulations were repeated 1000 times and power was estimated as the proportion where the contrast between WLC and MM had p\<0.05.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.5||0.9|TWO_SIDED|95.0|-0.3|0.24||The p-value is adjusted for multiple comparisons using per Benjamini \& Hochberg (1995) across the five primary outcome measures. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|Estimate is the mean difference in number of symptoms for MM above and beyond WLC (positive values denote higher number of symptoms for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's number of symptoms at baseline.||0.24|-0.30|0.90
70890173|NCT03224468|141266294|SUPERIORITY|Power was determined to be 83.6% using a Monte Carlo simulation approach in which data were simulated from a multi-level linear regression model with a subject-varying random intercept, a shared baseline across WLC and MMC, and fixed effects for a change over each time point. Simulated data were fit with a linear model estimated via GEE - simulations were repeated 1000 times and power was estimated as the proportion where the contrast between WLC and MM had p\<0.05.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.5||0.93|TWO_SIDED|95.0|-0.38|0.39||The p-value is adjusted for multiple comparisons using per Benjamini \& Hochberg (1995) across the five primary outcome measures. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|Estimate is the mean difference in number of symptoms for MM above and beyond WLC (positive values denote higher number of symptoms for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's number of symptoms at baseline.||0.39|-0.38|0.93
70890174|NCT03224468|141266295|SUPERIORITY|Power was determined to be 90.4% using a Monte Carlo simulation approach in which data were simulated from a multi-level linear regression model with a subject-varying random intercept, a shared baseline across WLC and MMC, and fixed effects for a change over each time point. Simulated data were fit with a linear model estimated via GEE - simulations were repeated 1000 times and power was estimated as the proportion where the contrast between WLC and MM had p\<0.05.|Mean Difference (Net)|-0.79|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-1.3|-0.43||The p-value is adjusted for multiple comparisons using per Benjamini \& Hochberg (1995) across the five primary outcome measures. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|Estimate is the mean difference in number of symptoms for MM above and beyond WLC (positive values denote higher number of symptoms for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's number of symptoms at baseline.||-0.43|-1.30|<0.001
70890175|NCT03224468|141266296|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-1.0|2.5|||||Estimate is the mean difference in number of symptoms for MM above and beyond WLC (positive values denote higher number of symptoms for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's score at baseline.||2.5|-1.0|
70890176|NCT03224468|141266298|SUPERIORITY||Mean Difference (Net)|-7.7|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-19.0|3.5|||||Estimate is the mean difference in the congruency cost on response time for MM above and beyond WLC (positive values indicate higher cost for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||3.5|-19.0|
70890177|NCT03224468|141266299|SUPERIORITY||Mean Difference (Net)|-24.1|STANDARD_ERROR_OF_MEAN|11.2|||TWO_SIDED|95.0|-45.9|-2.2|||||Estimate is the mean difference in the switching cost on response time for MM above and beyond WLC (positive values indicate higher cost for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||-2.2|-45.9|
70890178|NCT03224468|141266300|SUPERIORITY||Mean Difference (Net)|0.002|STANDARD_ERROR_OF_MEAN|0.005|||TWO_SIDED|95.0|-0.007|0.011|||||Estimate is the mean difference in discriminability for MM above and beyond WLC (positive values indicate better ability to identify target items for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||0.011|-0.007|
70890179|NCT03224468|141266301|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-1.8|1.7|||||Estimate is the mean difference in number of total errors for MM above and beyond WLC (positive values indicate greater number of errors for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||1.7|-1.8|
70890180|NCT03224468|141266302|SUPERIORITY||Mean Difference (Net)|-3.6|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|-7.4|0.3|||||Estimate is the mean difference in number of repetition errors for MM above and beyond WLC (positive values indicate greater number of errors for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||0.3|-7.4|
70890181|NCT03224468|141266303|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.2|0.1|||||Estimate is the mean difference in discriminability for MM above and beyond WLC (positive values indicate a greater ability to recognize previously studied words for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||0.1|-0.2|
70890182|NCT03224468|141266304|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.2|1.0|||||Estimate is the mean difference in number recalled for MM above and beyond WLC (positive values indicate a greater ability to recall previously studied words for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||1.0|-0.2|
70890183|NCT01038921|141266326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0||||0.013|||||||Mixed Models Analysis|||Average change in systolic blood pressure from pre-treatment baseline to post-treatment at 10 weeks when those subjects were on Melatonin was compared to the average change in systolic blood pressure from pre-treatment baseline to post-treatment at 10 weeks when those same subjects were on Placebo using an intent-to-treat mixed model. Power was estimated based on having 30 subjects completing both the melatonin arm and the placebo arm.||||0.013
70890184|NCT03586999|141266344|SUPERIORITY||proportion|0.3||||0.1|TWO_SIDED|90.0||||The proportion achieving a complete response will be calculated and will compared to null proportion of 30%. The population proportion for complete response rate, p-value and 90% confidence intervals for the complete response rate will be calculated.|t-test, 2 sided|||The study was to be suspended, if, at any time, there was sufficient evidence to suggest that the true probability of achieving a complete response falls below 30% while assuming the treatment drug will elicit a 56% complete response rate. Statistically significant evidence for this low complete response rate is defined as an observed complete response rate whose upper one-sided 90% confidence limit is 0-30%. Sample size calculations were made assuming 80% power.||||.1
70890185|NCT04096560|141266354|SUPERIORITY||LS Mean Difference|26.4|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|20.07|32.73||The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.|MMRM|The unstructured covariance structure was used for the repeated statement.||||32.73|20.07|<0.001
70890186|NCT04096560|141266354|SUPERIORITY||LS Mean Difference|29.9|STANDARD_ERROR_OF_MEAN|3.08|<|0.001|TWO_SIDED|95.0|23.68|36.07||The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.|MMRM|The unstructured covariance structure was used for the repeated statement.||||36.07|23.68|<0.001
70890187|NCT04096560|141266354|SUPERIORITY||LS Mean Difference|35.0|STANDARD_ERROR_OF_MEAN|3.14|<|0.001|TWO_SIDED|95.0|28.73|41.34||The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.|MMRM|The unstructured covariance structure was used for the repeated statement.||||41.34|28.73|<0.001
70890188|NCT04096560|141266361|SUPERIORITY||LS Mean Difference|-10.1|STANDARD_ERROR_OF_MEAN|1.96|<|0.001|TWO_SIDED|95.0|-14.07|-6.16||The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.|MMRM|The unstructured covariance structure was used for the repeated statement.||||-6.16|-14.07|<0.001
70890189|NCT04096560|141266361|SUPERIORITY||LS Mean Difference|-11.4|STANDARD_ERROR_OF_MEAN|1.89|<|0.001|TWO_SIDED|95.0|-15.2|-7.56||The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.|MMRM|The unstructured covariance structure was used for the repeated statement.||||-7.56|-15.20|<0.001
70890190|NCT04096560|141266361|SUPERIORITY||LS Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|1.95|<|0.001|TWO_SIDED|95.0|-16.96|-9.09||The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.|MMRM|The unstructured covariance structure was used for the repeated statement.||||-9.09|-16.96|<0.001
70890191|NCT04096560|141266362|SUPERIORITY||IRR|0.05|||=|0.002|TWO_SIDED|95.0|0.007|0.317||The incidence rate was the exponentiated LS means and the incidence rate ratio (IRR) was the exponentiated LS mean differences from the generalized estimating equation (GEE) Poisson regression model.|MMRM|The Poisson regression with natural log link was on the count of cataplexy per week.||||0.317|0.007|=0.002
70890192|NCT04096560|141266362|SUPERIORITY||IRR|0.2|||=|0.019|TWO_SIDED|95.0|0.05|0.767||The incidence rate was the exponentiated LS means and the IRR was the exponentiated LS mean differences from the GEE Poisson regression model.|MMRM|The Poisson regression with natural log link was on the count of cataplexy per week.||||0.767|0.050|=0.019
70890193|NCT04096560|141266362|SUPERIORITY||IRR|0.15|||=|0.001|TWO_SIDED|95.0|0.047|0.482||The incidence rate was the exponentiated LS means and the IRR was the exponentiated LS mean differences from the GEE Poisson regression model.|MMRM|The Poisson regression with natural log link was on the count of cataplexy per week.||||0.482|0.047|=0.001
70890194|NCT00534352|141266379|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was shown for Cmin as the 90% confidence intervals (CI) of the LSmean ratio was within the 80-125% limits.|Least Square (LS) mean ratio|95.47||||||90.0|82.77|110.1||No p-values.|Mixed Models Analysis (Cmin)|The linear mixed effects model was controlled for treatment as fixed effects, and subject as a random effect.|The results are for the mean ratio of Cmin. Numerator: Treatment B Denominator: Treatment A|Previous studies showed that the intrasubject variability on the log transformed Cmax and AUC12h of TMC125 was less than or equal to 40%. Based on this and with complete data on 20 patients, the 90% CI of the true ratio of the means was expected to be contained within 81-124% of the observed ratio of the means.||110.1|82.77|
70890195|NCT00534352|141266379|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was shown for Cmax as the 90% confidence intervals (CI) of the LSmean ratio was within the 80-125% limits.|Least Square (LS) mean ratio|102.6||||||90.0|92.91|113.3||No p-values.|Mixed Models Analysis (Cmax)|The linear mixed effects model was controlled for treatment as fixed effects, and subject as a random effect.|The results are for the mean ratio of Cmax. Numerator: Treatment B Denominator: Treatment A|Previous studies showed that the intrasubject variability on the log transformed Cmax and AUC12h of TMC125 was less than or equal to 40%. Based on this and with complete data on 20 patients, the 90% CI of the true ratio of the means was expected to be contained within 81-124% of the observed ratio of the means.||113.3|92.91|
70890196|NCT00534352|141266379|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was shown for AUC24 as the 90% confidence intervals (CI) of the LSmean ratio was within the 80-125% limits.|LS means of ratios|98.97||||||90.0|89.23|109.8||No p-values.|Mixed Models Analysis (AUC24)|The linear mixed effects model was controlled for treatment as fixed effects, and subject as a random effect.|The results are for the mean ratio of AUC24. Numerator: Treatment B Denominator: Treatment A|Previous studies showed that the intrasubject variability on the log transformed Cmax and AUC12h of TMC125 was less than or equal to 40%. Based on this and with complete data on 20 patients, the 90% CI of the true ratio of the means was expected to be contained within 81-124% of the observed ratio of the means.||109.8|89.23|
70890197|NCT00534352|141266379|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was shown for Css,av as the 90% confidence intervals (CI) of the LSmean ratio was within the 80-125% limits.|Least Square (LS) mean ratio|99.3||||||90.0|89.39|110.3||No p-values.|Mixed Models Analysis (Css,av)|The linear mixed effects model was controlled for treatment as fixed effects, and subject as a random effect.|The results are for the mean ratio of Css,av. Numerator: Treatment B Denominator: Treatment A|Previous studies showed that the intrasubject variability on the log transformed Cmax and AUC12h of TMC125 was less than or equal to 40%. Based on this and with complete data on 20 patients, the 90% CI of the true ratio of the means was expected to be contained within 81-124% of the observed ratio of the means.||110.3|89.39|
70890198|NCT01591746|141266391|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
70890199|NCT01591746|141266392|SUPERIORITY|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||||||0.56
70890200|NCT01591746|141266393|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Right breast initial percent volume expansion||||0.45
70890201|NCT01591746|141266393|SUPERIORITY|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||Left breast initial percent volume expansion||||0.98
70890202|NCT01591746|141266394|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
70890203|NCT01591746|141266395|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
70890204|NCT01591746|141266396|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
70890205|NCT02673697|141266440|NON_INFERIORITY|"The primary analysis will calculate the Bayesian posterior probability that the difference \[MACCECONTROL~\- MACCEPERCEVAL\] is lower than 0.05 (predetermined non-inferiority margin): The null hypothesis will be rejected, and non-inferiority concluded, if the posterior probability exceeds 0.9775 at the final analysis."||||||0.9914||||||The null hypothesis will be rejected, and non-inferiority concluded, if the posterior probability exceeds 0.9775 at the final analysis.|Bayesian|||"A the primary analysis will compare Perceval valve (Treatment arm) vs. standard sutured stented valve (Control arm) on the Per Protocol population.~A one-sided non-inferiority test, using the non-inferiority margin Δ=0.05, will be performed to compare the two arms on the proportion of subjects that are event-free at one year (primary analysis)."||||0.9914
70890206|NCT01070810|141266446|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.40
70890207|NCT01070810|141266447|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.97|TWO_SIDED|95.0|0.61|1.62|||Regression, Cox|||Time to shock reversal was complicated by a high incidence of death prior to the event. To account for this we classified death as a competing risk event and used the estimated cumulative incidence function (CIF) to illustrate the comparison of CIFs between the two treatment groups using the Fine-Gray competing risk model. We tested the subdistribution hazards of these two CIF functions and obtained the estimated hazard ratio with 95% confidence intervals.||1.62|0.61|0.97
70890208|NCT01070810|141266448|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
70890209|NCT01070810|141266449|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
70890210|NCT01070810|141266450|SUPERIORITY|||||||0.1|||||||Chi-squared|||||||0.10
70890211|NCT03299192|141266470|SUPERIORITY|||||||0.001||||||This feasibility study is small and not designed to look at outcome statistics|GEE with Ancova features|||||||.001
70890212|NCT01418209|141266473|SUPERIORITY_OR_OTHER|||||||0.02||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo||||0.02
70890213|NCT01418209|141266473|SUPERIORITY_OR_OTHER|||||||0.02||||||p-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold of statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo||||0.02
70890214|NCT01418209|141266474|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||VMS frequency values were log transformed for modeling.||||<0.001
70890215|NCT01418209|141266474|SUPERIORITY_OR_OTHER|||||||0.005||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||VMS frequency values were log transformed for modeling.||||0.005
70890216|NCT01418209|141266476|SUPERIORITY_OR_OTHER|||||||0.01||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo||||0.01
70890217|NCT01418209|141266476|SUPERIORITY_OR_OTHER|||||||0.07||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo||||0.07
70890218|NCT01418209|141266478|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo.||||<0.001
70890219|NCT01418209|141266478|SUPERIORITY_OR_OTHER|||||||0.03||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo||||0.03
70890220|NCT04737538|141266480|OTHER||Mean Difference (Final Values)|-11.0|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|-13.3|-8.8|||Non-parametric method (Van Elteren test)|||||-8.8|-13.3|<0.0001
70890221|NCT04737538|141266481|OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|1.01||0.4488|TWO_SIDED|95.0|-1.6|2.4|||Non-parametric method (Van Elteren test)|||||2.4|-1.6|0.4488
70890222|NCT04737538|141266482|OTHER||Mean Difference (Final Values)|-11.5|STANDARD_ERROR_OF_MEAN|1.18|<|0.0001|TWO_SIDED|95.0|-13.8|-9.1|||Non-parametric method (Van Elteren test)|||||-9.1|-13.8|<0.0001
70890223|NCT04666441|141266503|SUPERIORITY||Difference of LS Means|-0.57|STANDARD_ERROR_OF_MEAN|0.16||0.0004|TWO_SIDED|95.0|-0.88|-0.25|||ANCOVA|||Difference vs. Placebo (log10 copies/mL)||-0.25|-0.88|0.0004
70890224|NCT04666441|141266503|SUPERIORITY||Difference of LS Means|-0.66|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-0.99|-0.34|||ANCOVA|||Difference vs. Placebo (log10 copies/mL)||-0.34|-0.99|<0.0001
70890225|NCT04666441|141266503|SUPERIORITY||Difference of LS Means|-0.56|STANDARD_ERROR_OF_MEAN|0.16||0.0007|TWO_SIDED|95.0|-0.89|-0.24|||ANCOVA|||Difference vs. Placebo (log10 copies/mL)||-0.24|-0.89|0.0007
70890226|NCT04666441|141266503|SUPERIORITY||Difference of LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.05|-0.38|||ANCOVA|||Difference vs. Placebo (log10 copies/mL)||-0.38|-1.05|<0.0001
70890227|NCT04666441|141266503|SUPERIORITY||Difference of LS Means|-0.56|STANDARD_ERROR_OF_MEAN|0.16||0.0006||95.0|-0.88|-0.24|||ANCOVA|||Difference vs. Placebo (log10 copies/mL)||-0.24|-0.88|0.0006
70890228|NCT04666441|141266503|SUPERIORITY||Difference of LS Means|-0.56|STANDARD_ERROR_OF_MEAN|0.16||0.0007||95.0|-0.87|-0.24|||ANCOVA|||Difference vs. Placebo (log10 copies/mL)||-0.24|-0.87|0.0007
70890229|NCT04666441|141266504|SUPERIORITY||Difference of LS Means|-0.47|STANDARD_ERROR_OF_MEAN|0.13||0.0002||95.0|-0.72|-0.23|||ANCOVA|||||-0.23|-0.72|0.0002
70890230|NCT04666441|141266504|SUPERIORITY||Difference of LS Means|-0.57|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001||95.0|-0.82|-0.32|||ANCOVA|||||-0.32|-0.82|<0.0001
70890231|NCT04666441|141266504|SUPERIORITY||Difference of LS Means|-0.58|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001||95.0|-0.83|-0.33|||ANCOVA|||||-0.33|-0.83|<0.0001
70890232|NCT04666441|141266504|SUPERIORITY||Difference of LS Means|-0.49|STANDARD_ERROR_OF_MEAN|0.13||0.0002||95.0|-0.75|-0.24|||ANCOVA|||||-0.24|-0.75|0.0002
70890233|NCT04666441|141266504|SUPERIORITY||Difference of LS Means|-0.37|STANDARD_ERROR_OF_MEAN|0.13||0.004||95.0|-0.62|-0.12|||ANCOVA|||||-0.12|-0.62|0.0040
70890234|NCT04666441|141266504|SUPERIORITY||Difference of LS Means|-0.42|STANDARD_ERROR_OF_MEAN|0.12||0.0007||95.0|-0.67|-0.18|||ANCOVA|||||-0.18|-0.67|0.0007
70890235|NCT04666441|141266505|SUPERIORITY||Difference of LS Means|-0.57|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.82|-0.33|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.33|-0.82|<0.0001
70890236|NCT04666441|141266505|SUPERIORITY||Difference of LS Means|-0.65|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.9|-0.4|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.40|-0.90|<0.0001
70890237|NCT04666441|141266505|SUPERIORITY||Difference of LS Means|-0.7|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.97|-0.42|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.42|-0.97|<0.0001
70890238|NCT04666441|141266505|SUPERIORITY||Difference of LS Means|-0.88|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.19|-0.58|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.58|-1.19|<0.0001
70890239|NCT04666441|141266505|SUPERIORITY||Difference of LS Means|-0.58|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.84|-0.33|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.33|-0.84|<0.0001
70890240|NCT04666441|141266505|SUPERIORITY||Difference of LS Means|-0.69|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.95|-0.43|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.43|-0.95|<0.0001
70890241|NCT04666441|141266505|SUPERIORITY||Difference of LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.98|-0.44|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.44|-0.98|<0.0001
70890242|NCT04666441|141266505|SUPERIORITY||Difference of LS Means|-0.95|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.25|-0.64|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.64|-1.25|<0.0001
70890243|NCT04666441|141266505|SUPERIORITY||Difference of LS Means|-0.62|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.87|-0.37|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.37|-0.87|<0.0001
70890244|NCT04666441|141266505|SUPERIORITY||Difference of LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.93|-0.42|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.42|-0.93|<0.0001
70890245|NCT04666441|141266505|SUPERIORITY||Difference of LS Means|-0.72|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.99|-0.44|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.44|-0.99|<0.0001
70890246|NCT04666441|141266505|SUPERIORITY||Difference of LS Means|-0.93|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.25|-0.61|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.61|-1.25|<0.0001
70890247|NCT04666441|141266505|SUPERIORITY||Difference of LS Means|-0.56|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.8|-0.31|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.31|-0.80|<0.0001
70890248|NCT04666441|141266505|SUPERIORITY||Difference of LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.89|-0.38|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.38|-0.89|<0.0001
70890249|NCT04666441|141266505|SUPERIORITY||Difference of LS Means|-0.7|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.97|-0.43|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.43|-0.97|<0.0001
70890250|NCT04666441|141266505|SUPERIORITY||Difference of LS Means|-0.84|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.15|-0.52|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.52|-1.15|<0.0001
70890251|NCT04666441|141266505|SUPERIORITY||Difference of LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.76|-0.27|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.27|-0.76|<0.0001
70890252|NCT04666441|141266505|SUPERIORITY||Difference of LS Means|-0.58|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.83|-0.33|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.33|-0.83|<0.0001
70890253|NCT04666441|141266505|SUPERIORITY||Difference of LS Means|-0.55|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.82|-0.28|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.28|-0.82|<0.0001
70890254|NCT04666441|141266505|SUPERIORITY||Difference of LS Means|-0.63|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-0.95|-0.32|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.32|-0.95|<0.0001
70890255|NCT04666441|141266505|SUPERIORITY||Difference of LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.13||0.0002|TWO_SIDED|95.0|-0.73|-0.23|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.23|-0.73|0.0002
70890256|NCT04666441|141266505|SUPERIORITY||Difference of LS Means|-0.56|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.82|-0.31|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.31|-0.82|<0.0001
70890257|NCT04666441|141266505|SUPERIORITY||Difference of LS Means|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.87|-0.33|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.33|-0.87|<0.0001
70890258|NCT04666441|141266505|SUPERIORITY||Difference of LS Means|-0.84|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.16|-0.52|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.52|-1.16|<0.0001
70890259|NCT04666441|141266506|SUPERIORITY||Difference of LS Means|-0.41|STANDARD_ERROR_OF_MEAN|0.12||0.0005|TWO_SIDED|95.0|-0.64|-0.18|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.18|-0.64|0.0005
70890260|NCT04666441|141266506|SUPERIORITY||Difference of LS Means|-0.46|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.69|-0.23|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.23|-0.69|<0.0001
70890261|NCT04666441|141266506|SUPERIORITY||Difference of LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.75|-0.26|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.26|-0.75|<0.0001
70890262|NCT04666441|141266506|SUPERIORITY||Difference of LS Means|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.88|-0.32|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.32|-0.88|<0.0001
70890263|NCT04666441|141266506|SUPERIORITY||Difference of LS Means|-0.45|STANDARD_ERROR_OF_MEAN|0.12||0.0003|TWO_SIDED|95.0|-0.69|-0.21|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.21|-0.69|0.0003
70890264|NCT04666441|141266506|SUPERIORITY||Difference of LS Means|-0.53|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.77|-0.29|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.29|-0.77|<0.0001
70890265|NCT04666441|141266506|SUPERIORITY||Difference of LS Means|-0.53|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.78|-0.29|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.29|-0.78|<0.0001
70890266|NCT04666441|141266506|SUPERIORITY||Difference of LS Means|-0.69|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.98|-0.41|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.41|-0.98|<0.0001
70890267|NCT04666441|141266506|SUPERIORITY||Difference of LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.72|-0.25|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.25|-0.72|<0.0001
70890268|NCT04666441|141266506|SUPERIORITY||Difference of LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.74|-0.28|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.28|-0.74|<0.0001
70890269|NCT04666441|141266506|SUPERIORITY||Difference of LS Means|-0.54|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.79|-0.3|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.30|-0.79|<0.0001
70890270|NCT04666441|141266506|SUPERIORITY||Difference of LS Means|-0.7|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.99|-0.4|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.40|-0.99|<0.0001
70890271|NCT04666441|141266506|SUPERIORITY||Difference of LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.12||0.0009|TWO_SIDED|95.0|-0.63|-0.16|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.16|-0.63|0.0009
70890272|NCT04666441|141266506|SUPERIORITY||Difference of LS Means|-0.46|STANDARD_ERROR_OF_MEAN|0.12||0.0001|TWO_SIDED|95.0|-0.69|-0.23|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.23|-0.69|0.0001
70890273|NCT04666441|141266506|SUPERIORITY||Difference of LS Means|-0.52|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.77|-0.27|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.27|-0.77|<0.0001
70890274|NCT04666441|141266506|SUPERIORITY||Difference of LS Means|-0.63|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.92|-0.34|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.34|-0.92|<0.0001
70890275|NCT04666441|141266506|SUPERIORITY||Difference of LS Means|-0.34|STANDARD_ERROR_OF_MEAN|0.12||0.0046|TWO_SIDED|95.0|-0.57|-0.1|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.10|-0.57|0.0046
70890276|NCT04666441|141266506|SUPERIORITY||Difference of LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.12||0.0011|TWO_SIDED|95.0|-0.62|-0.15|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.15|-0.62|0.0011
70890277|NCT04666441|141266506|SUPERIORITY||Difference of LS Means|-0.37|STANDARD_ERROR_OF_MEAN|0.13||0.0029|TWO_SIDED|95.0|-0.62|-0.13|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.13|-0.62|0.0029
70890278|NCT04666441|141266506|SUPERIORITY||Difference of LS Means|-0.37|STANDARD_ERROR_OF_MEAN|0.15||0.012|TWO_SIDED|95.0|-0.66|-0.08|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.08|-0.66|0.0120
70890279|NCT04666441|141266506|SUPERIORITY||Difference of LS Means|-0.33|STANDARD_ERROR_OF_MEAN|0.12||0.0062|TWO_SIDED|95.0|-0.56|-0.09|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.09|-0.56|0.0062
70890280|NCT04666441|141266506|SUPERIORITY||Difference of LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.12||0.0011|TWO_SIDED|95.0|-0.62|-0.16|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.16|-0.62|0.0011
70890281|NCT04666441|141266506|SUPERIORITY||Difference of LS Means|-0.41|STANDARD_ERROR_OF_MEAN|0.13||0.0011|TWO_SIDED|95.0|-0.66|-0.17|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.17|-0.66|0.0011
70890282|NCT04666441|141266506|SUPERIORITY||Difference of LS Means|-0.58|STANDARD_ERROR_OF_MEAN|0.15||0.0001|TWO_SIDED|95.0|-0.87|-0.29|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.29|-0.87|0.0001
70890283|NCT04666441|141266510|SUPERIORITY||Difference of LS Means|-0.49|STANDARD_ERROR_OF_MEAN|0.18||0.007||95.0|-0.85|-0.14|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 3 (log10 copies/mL)||-0.14|-0.85|0.0070
70890284|NCT04666441|141266510|SUPERIORITY||Difference of LS Means|-0.69|STANDARD_ERROR_OF_MEAN|0.19||0.0002|TWO_SIDED|95.0|-1.06|-0.33|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 3 (log10 copies/mL)||-0.33|-1.06|0.0002
70890285|NCT04666441|141266510|SUPERIORITY||Difference of LS Means|-0.63|STANDARD_ERROR_OF_MEAN|0.19||0.0008||95.0|-1.0|-0.26|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 3 (log10 copies/mL)||-0.26|-1.00|0.0008
70890286|NCT04666441|141266510|SUPERIORITY||Difference of LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.19||0.0125||95.0|-0.85|-0.1|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 3 (log10 copies/mL)||-0.10|-0.85|0.0125
70890287|NCT04666441|141266510|SUPERIORITY||Difference of LS Means|-0.34|STANDARD_ERROR_OF_MEAN|0.18||0.0696||95.0|-0.7|0.03|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 3 (log10 copies/mL)||0.03|-0.70|0.0696
70890288|NCT04666441|141266510|SUPERIORITY||Difference of LS Means|-0.43|STANDARD_ERROR_OF_MEAN|0.18||0.0187|TWO_SIDED|95.0|-0.79|-0.07|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 3 (log10 copies/mL)||-0.07|-0.79|0.0187
70890289|NCT04666441|141266510|SUPERIORITY||Difference of LS Means|-0.96|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001||95.0|-1.39|-0.52|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 5 (log10 copies/mL)||-0.52|-1.39|<0.0001
70890290|NCT04666441|141266510|SUPERIORITY||Difference of LS Means|-1.09|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001||95.0|-1.53|-0.64|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 5 (log10 copies/mL)||-0.64|-1.53|<0.0001
70890291|NCT04666441|141266510|SUPERIORITY||Difference of LS Means|-1.03|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001||95.0|-1.48|-0.59|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 5 (log10 copies/mL)||-0.59|-1.48|<0.0001
70890292|NCT04666441|141266510|SUPERIORITY||Difference of LS Means|-1.05|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001||95.0|-1.5|-0.6|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 5 (log10 copies/mL)||-0.60|-1.50|<0.0001
70890293|NCT04666441|141266510|SUPERIORITY||Difference of LS Means|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.34|-0.46|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 5 (log10 copies/mL)||-0.46|-1.34|<0.0001
70890294|NCT04666441|141266510|SUPERIORITY||Difference of LS Means|-0.92|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001||95.0|-1.35|-0.48|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 5 (log10 copies/mL)||-0.48|-1.35|<0.0001
70890295|NCT04666441|141266510|SUPERIORITY||Difference of LS Means|-0.79|STANDARD_ERROR_OF_MEAN|0.22||0.0004||95.0|-1.23|-0.35|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 7 (log10 copies/mL)||-0.35|-1.23|0.0004
70890296|NCT04666441|141266510|SUPERIORITY||Difference of LS Means|-0.63|STANDARD_ERROR_OF_MEAN|0.23||0.0058||95.0|-1.08|-0.18|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 7 (log10 copies/mL)||-0.18|-1.08|0.0058
70890297|NCT04666441|141266510|SUPERIORITY||Difference of LS Means|-0.66|STANDARD_ERROR_OF_MEAN|0.23||0.0046||95.0|-1.11|-0.2|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 7 (log10 copies/mL)||-0.20|-1.11|0.0046
70890298|NCT04666441|141266510|SUPERIORITY||Difference of LS Means|-0.73|STANDARD_ERROR_OF_MEAN|0.23||0.0019||95.0|-1.18|-0.27|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 7 (log10 copies/mL)||-0.27|-1.18|0.0019
70890299|NCT04666441|141266510|SUPERIORITY||Difference of LS Means|-0.89|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001||95.0|-1.33|-0.44|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 7 (log10 copies/mL)||-0.44|-1.33|<0.0001
70890300|NCT04666441|141266510|SUPERIORITY||Difference of LS Means|-0.6|STANDARD_ERROR_OF_MEAN|0.22||0.0079||95.0|-1.04|-0.16|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 7 (log10 copies/mL)||-0.16|-1.04|0.0079
70890301|NCT04666441|141266510|SUPERIORITY||Difference of LS Means|-0.45|STANDARD_ERROR_OF_MEAN|0.23||0.0515||95.0|-0.9|0.0|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 15 (log10 copies/mL)||0.00|-0.90|0.0515
70890302|NCT04666441|141266510|SUPERIORITY||Difference of LS Means|-0.31|STANDARD_ERROR_OF_MEAN|0.23||0.1864||95.0|-0.77|0.15|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 15 (log10 copies/mL)||0.15|-0.77|0.1864
70890303|NCT04666441|141266510|SUPERIORITY||Difference of LS Means|-0.25|STANDARD_ERROR_OF_MEAN|0.24||0.2866||95.0|-0.72|0.21|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 15 (log10 copies/mL)||0.21|-0.72|0.2866
70890304|NCT04666441|141266510|SUPERIORITY||Difference of LS Means|-0.11|STANDARD_ERROR_OF_MEAN|0.24||0.647||95.0|-0.58|0.36|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 15 (log10 copies/mL)||0.36|-0.58|0.6470
70890305|NCT04666441|141266510|SUPERIORITY||Difference of LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.23||0.028||95.0|-0.97|-0.06|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 15 (log10 copies/mL)||-0.06|-0.97|0.0280
70890306|NCT04666441|141266510|SUPERIORITY||Difference of LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.23||0.0854||95.0|-0.84|0.05|||Mixed Models Analysis|||Difference vs. Placebo, by Day 15 (log10 copies/mL)||0.05|-0.84|0.0854
70890307|NCT04666441|141266510|SUPERIORITY||Difference of LS Means|-0.31|STANDARD_ERROR_OF_MEAN|0.19||0.1078|TWO_SIDED|95.0|-0.69|0.07|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 22 (log10 copies/mL)||0.07|-0.69|0.1078
70890308|NCT04666441|141266510|SUPERIORITY||Difference of LS Means|-0.24|STANDARD_ERROR_OF_MEAN|0.19||0.2235||95.0|-0.62|0.14|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 22 (log10 copies/mL)||0.14|-0.62|0.2235
70890309|NCT04666441|141266510|SUPERIORITY||Difference of LS Means|-0.29|STANDARD_ERROR_OF_MEAN|0.2||0.1369||95.0|-0.68|0.09|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 22 (log10 copies/mL)||0.09|-0.68|0.1369
70890310|NCT04666441|141266510|SUPERIORITY||Difference of LS Means|-0.09|STANDARD_ERROR_OF_MEAN|0.2||0.661||95.0|-0.48|0.31|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 22 (log10 copies/mL)||0.31|-0.48|0.6610
70890311|NCT04666441|141266510|SUPERIORITY||Difference of LS Means|-0.43|STANDARD_ERROR_OF_MEAN|0.19||0.0284||95.0|-0.81|-0.05|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 22 (log10 copies/mL)||-0.05|-0.81|0.0284
70890312|NCT04666441|141266510|SUPERIORITY||Difference of LS Means|-0.33|STANDARD_ERROR_OF_MEAN|0.19||0.08||95.0|-0.71|0.04|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 22 (log10 copies/mL)||0.04|-0.71|0.0800
70890313|NCT03149328|141266521|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates).||||||0.3||||||Threshold for statistical significance was p=0.05|ANCOVA|||We will examine the trajectories of outcome measures for patients in the comparator and intervention groups. The area under the curve (AUC) will be calculated for each trajectory during the period that the patient is participating to create a summary score. Null Hypothesis is that both groups are the same.||||0.30
70890314|NCT03149328|141266522|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates).||||||0.28|||||||ANCOVA|||We will examine the trajectories of outcome measures for patients in the comparator and intervention groups. The area under the curve (AUC) will be calculated for each trajectory during the period that the patient is participating to create a summary score. Null Hypothesis = both groups are the same||||0.28
70890315|NCT03149328|141266523|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates)||||||0.22||||||Threshold for statistical Significance was p = 0.05|ANCOVA|||"Analysis of covariance (ANCOVA) will be used as the method of analysis to compare outcomes of both groups while controlling for within- and between-group differences, such as comorbidities, gender, age and dialysis type. ANCOVA is necessary to control for baseline and potential confounders.~Null hypotheses = No difference between groups in the number of hospitalizations"||||0.22
70890316|NCT03149328|141266523|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates)||||||0.1||||||Threshold for statistical Significance was p = 0.05|ANCOVA|||"Analysis of covariance (ANCOVA) will be used as the method of analysis to compare outcomes of both groups while controlling for within- and between-group differences, such as comorbidities, gender, age and dialysis type. ANCOVA is necessary to control for baseline and potential confounders.~Null hypotheses = No difference between groups in the number of emergency room visits"||||0.10
70890317|NCT03149328|141266524|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates)||||||0.18||||||Threshold for statistical significance p = 0.05|ANCOVA|||"Analysis of covariance (ANCOVA) will be used as the method of analysis to compare outcomes of both groups while controlling for within- and between-group differences, such as comorbidities, gender, age and dialysis type. ANCOVA is necessary to control for baseline and potential confounders.~Null hypotheses = No difference between groups"||||0.18
70890318|NCT03149328|141266525|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates)||||||0.79||||||Threshold for statistical significance p = 0.05|ANCOVA|||"Analysis of covariance (ANCOVA) will be used as the method of analysis to compare outcomes of both groups while controlling for within- and between-group differences, such as comorbidities, gender, age and dialysis type. ANCOVA is necessary to control for baseline and potential confounders.~Null hypotheses = No difference between groups"||||0.79
70890319|NCT03149328|141266526|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates)|||||<|0.001||||||Threshold for statistical significance p = 0.05|ANCOVA|||"Analysis of covariance (ANCOVA) will be used as the method of analysis to compare outcomes of both groups while controlling for within- and between-group differences, such as comorbidities, gender, age and dialysis type. ANCOVA is necessary to control for baseline and potential confounders.~Null hypotheses = No difference between groups"||||<0.001
70890320|NCT01208233|141266558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.735||||0.4962|TWO_SIDED|80.0|0.41|1.31|||Regression, Logistic|LOCF was used to impute missing data.||||1.31|0.41|0.4962
70890321|NCT01208233|141266558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.561||||0.2517|TWO_SIDED|80.0|0.29|1.07|||Regression, Logistic|The analysis was based on OC.||||1.07|0.29|0.2517
70890322|NCT01208233|141266559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|3.942||0.9716|TWO_SIDED|80.0|-4.972|5.254|||Mixed Models Analysis|||Paretic hand||5.254|-4.972|0.9716
70890323|NCT01208233|141266560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.789|STANDARD_ERROR_OF_MEAN|7.2392||0.1417|TWO_SIDED|80.0|1.401|20.177|||Mixed Models Analysis|||Paretic to non-paretic hand ratio (%)||20.177|1.401|0.1417
70890324|NCT01208233|141266561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.33|STANDARD_ERROR_OF_MEAN|5.4241||0.0611|TWO_SIDED|80.0|-17.351|-3.31|||Mixed Models Analysis|||Paretic hand||-3.310|-17.351|0.0611
70890325|NCT01208233|141266561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.235|STANDARD_ERROR_OF_MEAN|3.2899||0.9433|TWO_SIDED|80.0|-4.011|4.48|||Mixed Models Analysis|||Non-paretic hand||4.480|-4.011|0.9433
70890326|NCT01208233|141266562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.812|STANDARD_ERROR_OF_MEAN|6.8448||0.0654|TWO_SIDED|80.0|-21.668|-3.957|||Mixed Models Analysis|||Paretic to non-paretic hand ratio (%)||-3.957|-21.668|0.0654
70890327|NCT01208233|141266563|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.972||||0.951|TWO_SIDED|80.0|0.54|1.76|||Regression, Logistic|||LOCF was used to impute missing data.||1.76|0.54|0.9510
70890328|NCT01208233|141266564|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.854||||0.7234|TWO_SIDED|80.0|0.48|1.51|||Regression, Logistic|||LOCF was used to impute missing data.||1.51|0.48|0.7234
70890329|NCT01208233|141266565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.283|STANDARD_ERROR_OF_MEAN|0.6755||0.6759|TWO_SIDED|80.0|-1.156|0.589|||Mixed Models Analysis|||||0.589|-1.156|0.6759
70890330|NCT01208233|141266566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.433||||0.4213|TWO_SIDED|80.0|0.81|2.54|||Regression, Logistic|||BI \>=95, LOCF was used to impute missing data.||2.54|0.81|0.4213
70890331|NCT01208233|141266566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.651||||0.276|TWO_SIDED|80.0|0.92|2.98|||Regression, Logistic|||BI=100, LOCF was used to impute missing data.||2.98|0.92|0.2760
70890332|NCT01208233|141266567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.599|STANDARD_ERROR_OF_MEAN|4.4547||0.2118|TWO_SIDED|80.0|-0.15|11.348|||Mixed Models Analysis|||||11.348|-0.150|0.2118
70890333|NCT01208233|141266568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.062|STANDARD_ERROR_OF_MEAN|1.7844||0.5541|TWO_SIDED|80.0|-1.252|3.375|||Mixed Models Analysis|||||3.375|-1.252|0.5541
70890334|NCT01208233|141266569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.334|STANDARD_ERROR_OF_MEAN|0.4178||0.426|TWO_SIDED|80.0|-0.874|0.205|||Mixed Models Analysis|||||0.205|-0.874|0.4260
70890335|NCT01208233|141266570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.477|STANDARD_ERROR_OF_MEAN|5.4394||0.65|TWO_SIDED|80.0|-4.547|9.5|||Mixed Models Analysis|||(L+R)/28 × 100%||9.500|-4.547|0.6500
70890336|NCT01208233|141266570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.874|STANDARD_ERROR_OF_MEAN|6.7431||0.5671|TWO_SIDED|80.0|-4.834|12.583|||Mixed Models Analysis|||(L/14) × 100%||12.583|-4.834|0.5671
70890337|NCT01208233|141266570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.049|STANDARD_ERROR_OF_MEAN|5.2816||0.843|TWO_SIDED|80.0|-5.771|7.87|||Mixed Models Analysis|||(R/14) × 100%||7.870|-5.771|0.8430
70890338|NCT01208233|141266571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.0733||0.1512|TWO_SIDED|80.0|0.011|0.201|||Mixed Models Analysis|||(L R)/(L+R)||0.201|0.011|0.1512
70890339|NCT01208233|141266572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.279|STANDARD_ERROR_OF_MEAN|0.5041||0.0128|TWO_SIDED|80.0|-1.929|-0.629|||Mixed Models Analysis|||||-0.629|-1.929|0.0128
70890340|NCT01208233|141266573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.1226||0.4713|TWO_SIDED|80.0|-0.07|0.248|||Mixed Models Analysis|||||0.248|-0.070|0.4713
70890341|NCT01208233|141266580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.516|STANDARD_ERROR_OF_MEAN|2.7201||0.8501|TWO_SIDED|80.0|-4.026|2.995|||Mixed Models Analysis|||Non-paretic hand||2.995|-4.026|0.8501
70890342|NCT00132769|141266581|SUPERIORITY_OR_OTHER||Difference in LS Mean|1.48||||0.278|TWO_SIDED|95.0|-1.21|4.18|||ANCOVA|||||4.18|-1.21|0.278
70890343|NCT00132769|141266582|SUPERIORITY_OR_OTHER||Difference in Percent|-5.66||||0.543|TWO_SIDED|95.0|-24.45|13.13|||Cochran-Mantel-Haenszel|||||13.13|-24.45|0.543
70890344|NCT00132769|141266589|SUPERIORITY_OR_OTHER||LS mean ratio between treatments|0.84||||0.225|TWO_SIDED|95.0|0.63|1.12|||ANCOVA|||||1.12|0.63|0.225
70890345|NCT00560833|141266620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|||<|0.01|TWO_SIDED|95.0|-2.3|-0.4||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.4|-2.3|<0.01
70890346|NCT00560833|141266620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|||<|0.01|TWO_SIDED|95.0|-3.1|-1.2||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-1.2|-3.1|<0.01
70890347|NCT00560833|141266620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|||<|0.01|TWO_SIDED|95.0|-2.9|-1.0||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-1.0|-2.9|<0.01
70890348|NCT00560833|141266620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|||<|0.01|TWO_SIDED|95.0|-2.9|-1.0||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-1.0|-2.9|<0.01
70890349|NCT00560833|141266622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.06|TWO_SIDED|95.0|-2.0|0.0||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||0.0|-2.0|0.06
70890350|NCT00560833|141266622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|||<|0.01|TWO_SIDED|95.0|-3.0|-0.9||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.9|-3.0|<0.01
70890351|NCT00560833|141266622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|||<|0.01|TWO_SIDED|95.0|-2.9|-0.9||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.9|-2.9|<0.01
70890352|NCT00560833|141266622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|||<|0.01|TWO_SIDED|95.0|-2.6|-0.5||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.5|-2.6|<0.01
70890353|NCT00560833|141266623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.62|TWO_SIDED|95.0|-0.09|0.03||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||0.03|-0.09|0.62
70890354|NCT00560833|141266623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.02|TWO_SIDED|95.0|-0.12|-0.01||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.01|-0.12|0.02
70890355|NCT00560833|141266623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.01|TWO_SIDED|95.0|-0.13|-0.01||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.01|-0.13|0.01
70890356|NCT00560833|141266623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.02|TWO_SIDED|95.0|-0.12|-0.01||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.01|-0.12|0.02
70890357|NCT00560833|141266624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||1|TWO_SIDED|95.0|-0.06|0.07||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||0.07|-0.06|1.0
70890358|NCT00560833|141266624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.72|TWO_SIDED|95.0|-0.09|0.04||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||0.04|-0.09|0.72
70890359|NCT00560833|141266624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.13|TWO_SIDED|95.0|-0.12|0.01||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||0.01|-0.12|0.13
70890360|NCT00560833|141266624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.15|TWO_SIDED|95.0|-0.12|0.01||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||0.01|-0.12|0.15
70890361|NCT04193202|141266640|SUPERIORITY||Estimated difference|0.75||||0.034|TWO_SIDED|95.0|0.06|1.44|||Longitudinal ANCOVA|The model included terms for treatment group, visit, interaction of treatment by visit, gender, and baseline LCQ total score.|The estimated difference is the treatment difference in model based mean change from baseline at Week 12|||1.44|0.06|0.034
70890362|NCT04193202|141266641|OTHER||Estimated Difference|-6.92||||0.006|TWO_SIDED|95.0|-11.88|-1.97||Nominal p value, not controlled for multiplicity|Longitudinal ANCOVA|The model included terms for treatment group, visit, interaction of treatment by visit, gender, and baseline mean weekly cough severity VAS score.|The estimated difference is the treatment difference in model based mean change from baseline at Week 12.|||-1.97|-11.88|0.006
70890363|NCT04820673|141266655|OTHER||||||<|0.0001||||||P\<0.0001, calculated by t-test, corresponds to baseline response group domain scores in comparison to week-12 domain scores (CFB). CFB is calculated using available matching data for each domain. Higher domain scores indicate higher disease burden.|t-test, 2 sided|||Week 12 vs Baseline||||<.0001
70890364|NCT00587587|141266661|SUPERIORITY_OR_OTHER|||||||1||||||"P-value compares overall incidence of AEs between groups, ie Apligraf 12/17 and Control 10/13.~UADE is defined in 21CFR812.3(s)"|Fisher Exact|||Fisher's exact test used to evaluate treatment differences between Apligraf subjects and Control subjects experiencing any AEs.||||1.0000
70890365|NCT00587587|141266662|SUPERIORITY_OR_OTHER|||||||0.5863||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5863
70890366|NCT00587587|141266663|SUPERIORITY_OR_OTHER|||||||0.3783||95.0|||||Fisher Exact|||||||0.3783
70890367|NCT00587587|141266664|SUPERIORITY_OR_OTHER|||||||0.7149|||||||Wilcoxon (Mann-Whitney)|||Treatment differences in scar firmness evaluated using a 2-tailed Wilcoxon rank sum test with pooled variances.||||0.7149
70890368|NCT00587587|141266665|SUPERIORITY_OR_OTHER|||||||0.167||95.0|||||Wilcoxon (Mann-Whitney)|||Treatment differences in scar thickness evaluated using a 2-tailed Wilcoxon rank sum test||||0.1670
70890369|NCT00587587|141266666|SUPERIORITY_OR_OTHER|||||||0.7221|TWO_SIDED|0.0|||||Wilcoxon (Mann-Whitney)|||Global assessments analyzed as ordinal ranks. Treatment differences in global assessment evaluated using a 2-tailed Wilcoxon rank sum test with pooled variances.||||0.7221
70890370|NCT00587587|141266667|SUPERIORITY_OR_OTHER|||||||0.408|||||||Wilcoxon (Mann-Whitney)|||Global assessments analyzed as ordinal ranks. Treatment differences in global assessment evaluated using a 2-tailed Wilcoxon rank sum test with pooled variances.||||0.4080
70890371|NCT00587587|141266668|SUPERIORITY_OR_OTHER|||||||0.9556||0.0|||||Wilcoxon (Mann-Whitney)|||Differences evaluated using a 2-tailed Wilcoxon rank sum test with pooled variances.||||0.9556
70890372|NCT01138124|141266669|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.04|||<|0.0001|TWO_SIDED|95.0|1.51|2.75|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||2.75|1.51|<0.0001
70890373|NCT01138124|141266669|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.82||||0.0001|TWO_SIDED|95.0|1.34|2.46|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.46|1.34|0.0001
70890374|NCT01138124|141266669|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.52||||0.0627|TWO_SIDED|95.0|0.98|2.36|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||2.36|0.98|0.0627
70890375|NCT01138124|141266669|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.33||||0.2183|TWO_SIDED|95.0|0.85|2.08|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.08|0.85|0.2183
70890376|NCT01138124|141266670|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.82|||<|0.0001|TWO_SIDED|95.0|1.86|4.28|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||4.28|1.86|<0.0001
70890377|NCT01138124|141266670|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.53|||<|0.0001|TWO_SIDED|95.0|1.66|3.85|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy"|||3.85|1.66|<0.0001
70890378|NCT01138124|141266670|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.75||||0.001|TWO_SIDED|95.0|1.51|5.03|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||5.03|1.51|0.001
70890379|NCT01138124|141266670|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.44||||0.0042|TWO_SIDED|95.0|1.32|4.49|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||4.49|1.32|0.0042
70890380|NCT01138124|141266670|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.8||||0.0645|TWO_SIDED|95.0|0.97|3.36|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.36|0.97|0.0645
70890381|NCT01138124|141266670|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.65||||0.1232|TWO_SIDED|95.0|0.87|3.11|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||3.11|0.87|0.1232
70890382|NCT01138124|141266670|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|0.55||||0.316|TWO_SIDED|95.0|0.17|1.78|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.78|0.17|0.3160
70890383|NCT01138124|141266670|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.48||||0.2234|TWO_SIDED|95.0|0.15|1.57|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||1.57|0.15|0.2234
70890384|NCT01138124|141266670|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.35||||0.3071|TWO_SIDED|95.0|0.76|2.42|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.42|0.76|0.3071
70890385|NCT01138124|141266670|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.17||||0.6062|TWO_SIDED|95.0|0.65|2.11|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.11|0.65|0.6062
70890386|NCT01138124|141266670|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.31||||0.5205|TWO_SIDED|95.0|0.58|2.97|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.97|0.58|0.5205
70890387|NCT01138124|141266670|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.11||||0.8042|TWO_SIDED|95.0|0.48|2.57|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.57|0.48|0.8042
70890388|NCT01138124|141266671|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|3.15|||<|0.0001|TWO_SIDED|95.0|2.04|4.86|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||4.86|2.04|<0.0001
70890389|NCT01138124|141266671|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.88|||<|0.0001|TWO_SIDED|95.0|1.85|4.46|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||4.46|1.85|<0.0001
70890390|NCT01138124|141266671|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.75||||0.0015|TWO_SIDED|95.0|1.47|5.13|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||5.13|1.47|0.0015
70890391|NCT01138124|141266671|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.45||||0.0053|TWO_SIDED|95.0|1.31|4.62|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||4.62|1.31|0.0053
70890392|NCT01138124|141266671|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.68||||0.0777|TWO_SIDED|95.0|0.94|2.99|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.99|0.94|0.0777
70890393|NCT01138124|141266671|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.5||||0.1762|TWO_SIDED|95.0|0.83|2.69|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.69|0.83|0.1762
70890394|NCT01138124|141266671|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|0.82||||0.699|TWO_SIDED|95.0|0.29|2.28|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.28|0.29|0.6990
70890395|NCT01138124|141266671|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.72||||0.5274|TWO_SIDED|95.0|0.26|2.01|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.01|0.26|0.5274
70890396|NCT01138124|141266671|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.34||||0.3245|TWO_SIDED|95.0|0.75|2.39|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.39|0.75|0.3245
70890397|NCT01138124|141266671|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.15||||0.6388|TWO_SIDED|95.0|0.64|2.07|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.07|0.64|0.6388
70890398|NCT01138124|141266671|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.11||||0.796|TWO_SIDED|95.0|0.49|2.51|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.51|0.49|0.796
70890399|NCT01138124|141266671|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.94||||0.8772|TWO_SIDED|95.0|0.41|2.15|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.15|0.41|0.8772
70890400|NCT01138124|141266672|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.9|||<|0.0001|TWO_SIDED|95.0|1.88|4.47|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||4.47|1.88|<0.0001
70890401|NCT01138124|141266672|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.65|||<|0.0001|TWO_SIDED|95.0|1.71|4.11|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||4.11|1.71|<0.0001
70890402|NCT01138124|141266672|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.19||||0.0212|TWO_SIDED|95.0|1.12|4.25|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||4.25|1.12|0.0212
70890403|NCT01138124|141266672|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.95||||0.0522|TWO_SIDED|95.0|0.99|3.81|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||3.81|0.99|0.0522
70890404|NCT01138124|141266672|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.87||||0.0337|TWO_SIDED|95.0|1.05|3.32|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.32|1.05|0.0337
70890405|NCT01138124|141266672|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.64||||0.0947|TWO_SIDED|95.0|0.92|2.95|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.95|0.92|0.0947
70890406|NCT01138124|141266672|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.42||||0.3928|TWO_SIDED|95.0|0.64|3.16|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||3.16|0.64|0.3928
70890407|NCT01138124|141266672|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.21||||0.6502|TWO_SIDED|95.0|0.54|2.72|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.72|0.54|0.6502
70890408|NCT01138124|141266672|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.34||||0.3275|TWO_SIDED|95.0|0.75|2.39|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.39|0.75|0.3275
70890409|NCT01138124|141266672|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.15||||0.6365|TWO_SIDED|95.0|0.64|2.08|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.08|0.64|0.6365
70890410|NCT01138124|141266672|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.01||||0.9858|TWO_SIDED|95.0|0.42|2.41|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.41|0.42|0.9858
70890411|NCT01138124|141266672|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.87||||0.7671|TWO_SIDED|95.0|0.36|2.12|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.12|0.36|0.7671
70890412|NCT01138124|141266673|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.79||||0.0031|TWO_SIDED|95.0|1.22|2.63|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||2.63|1.22|0.0031
70890413|NCT01138124|141266673|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.68||||0.0095|TWO_SIDED|95.0|1.13|2.49|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||2.49|1.13|0.0095
70890414|NCT01138124|141266673|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.65||||0.097|TWO_SIDED|95.0|0.91|2.99|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||2.99|0.91|0.0970
70890415|NCT01138124|141266673|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.63||||0.1123|TWO_SIDED|95.0|0.89|2.97|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||2.97|0.89|0.1123
70890416|NCT01138124|141266674|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.53||||0.0012|TWO_SIDED|95.0|1.44|4.44|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)"|||4.44|1.44|0.0012
70890417|NCT01138124|141266674|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.34||||0.0034|TWO_SIDED|95.0|1.32|4.14|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||4.14|1.32|0.0034
70890418|NCT01138124|141266674|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.18||||0.0856|TWO_SIDED|95.0|0.9|5.32|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||5.32|0.9|0.0856
70890419|NCT01138124|141266674|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.14||||0.0996|TWO_SIDED|95.0|0.87|5.28|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||5.28|0.87|0.0996
70890420|NCT01138124|141266674|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.89||||0.0563|TWO_SIDED|95.0|0.98|3.63|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.63|0.98|0.0563
70890421|NCT01138124|141266674|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.77||||0.0896|TWO_SIDED|95.0|0.92|3.43|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||3.43|0.92|0.0896
70890422|NCT01138124|141266674|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.4||||0.5308|TWO_SIDED|95.0|0.49|4.01|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||4.01|0.49|0.5308
70890423|NCT01138124|141266674|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.39||||0.5458|TWO_SIDED|95.0|0.48|4.02|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||4.02|0.48|0.5458
70890424|NCT01138124|141266674|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|0.87||||0.7744|TWO_SIDED|95.0|0.35|2.19|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.19|0.35|0.7744
70890425|NCT01138124|141266674|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.83||||0.6999|TWO_SIDED|95.0|0.33|2.11|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||2.11|0.33|0.6999
70890426|NCT01138124|141266674|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.32||||0.6528|TWO_SIDED|95.0|0.39|4.47|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||4.47|0.39|0.6528
70890427|NCT01138124|141266674|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.3||||0.6722|TWO_SIDED|95.0|0.38|4.47|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||4.47|0.38|0.6722
70890428|NCT01138124|141266675|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|3.24|||<|0.0001|TWO_SIDED|95.0|1.79|5.85|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||5.85|1.79|<0.0001
70890429|NCT01138124|141266675|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.9||||0.0005|TWO_SIDED|95.0|1.59|5.28|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||5.28|1.59|0.0005
70890430|NCT01138124|141266675|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.54||||0.042|TWO_SIDED|95.0|1.03|6.25|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||6.25|1.03|0.042
70890431|NCT01138124|141266675|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.4||||0.0603|TWO_SIDED|95.0|0.96|5.98|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||5.98|0.96|0.0603
70890432|NCT01138124|141266675|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.35||||0.3762|TWO_SIDED|95.0|0.69|2.65|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.65|0.69|0.3762
70890433|NCT01138124|141266675|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.33||||0.4073|TWO_SIDED|95.0|0.68|2.63|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||2.63|0.68|0.4073
70890434|NCT01138124|141266675|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|0.95||||0.9294|TWO_SIDED|95.0|0.29|3.12|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||3.12|0.29|0.9294
70890435|NCT01138124|141266675|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.99||||0.9875|TWO_SIDED|95.0|0.3|3.29|||Wilcoxon (Mann-Whitney)||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||3.29|0.3|0.9875
70890436|NCT01138124|141266675|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.19||||0.66|TWO_SIDED|95.0|0.54|2.63|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.63|0.54|0.66
70890437|NCT01138124|141266675|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||0.811|TWO_SIDED|95.0|0.5|2.45|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||2.45|0.5|0.8110
70890438|NCT01138124|141266675|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.7||||0.3336|TWO_SIDED|95.0|0.58|4.96|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||4.96|0.58|0.3336
70890439|NCT01138124|141266675|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.63||||0.3782|TWO_SIDED|95.0|0.55|4.84|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||4.84|0.55|0.3782
70890440|NCT01138124|141266676|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.89||||0.0841|TWO_SIDED|95.0|0.92|3.88|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||3.88|0.92|0.0841
70890441|NCT01138124|141266676|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.75||||0.1313|TWO_SIDED|95.0|0.85|3.63|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||3.63|0.85|0.1313
70890442|NCT01138124|141266676|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.03||||0.1488|TWO_SIDED|95.0|0.78|5.34|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||5.34|0.78|0.1488
70890443|NCT01138124|141266676|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.05||||0.1495|TWO_SIDED|95.0|0.77|5.46|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||5.46|0.77|0.1495
70890444|NCT01138124|141266676|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.44||||0.0013|TWO_SIDED|95.0|1.42|4.22|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||4.22|1.42|0.0013
70890445|NCT01138124|141266676|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.34||||0.0026|TWO_SIDED|95.0|1.35|4.07|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||4.07|1.35|0.0026
70890446|NCT01138124|141266676|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.78||||0.2421|TWO_SIDED|95.0|0.68|4.69|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||4.69|0.68|0.2421
70890447|NCT01138124|141266676|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.7||||0.2899|TWO_SIDED|95.0|0.64|4.53|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||4.53|0.64|0.2899
70890448|NCT01138124|141266676|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|0.99||||0.9723|TWO_SIDED|95.0|0.42|2.29|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.29|0.42|0.9723
70890449|NCT01138124|141266676|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.91||||0.8206|TWO_SIDED|95.0|0.39|2.13|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||2.13|0.39|0.8206
70890450|NCT01138124|141266676|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.15||||0.8135|TWO_SIDED|95.0|0.35|3.82|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||3.82|0.35|0.8135
70890451|NCT01138124|141266676|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.15||||0.8173|TWO_SIDED|95.0|0.34|3.86|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||3.86|0.34|0.8173
70890452|NCT00767000|141266705|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.51|||<|0.001||95.0|-0.8|-0.22|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||-0.22|-0.80|<0.001
70890453|NCT00767000|141266705|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.64|||<|0.001||95.0|-0.93|-0.36|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||-0.36|-0.93|<0.001
70890454|NCT00767000|141266705|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.81|||<|0.001||95.0|-1.1|-0.53|||Contrained longitudinal model|||Analysis for change from baseline to Week 14||-0.53|-1.10|<0.001
70890455|NCT00767000|141266705|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.75|||<|0.001||95.0|-1.04|-0.46|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||-0.46|-1.04|<0.001
70890456|NCT00767000|141266706|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-36.6|||<|0.001||95.0|-55.6|-17.5|||Constrained longitudial model|||Analysis for change from baseline to Week 14||-17.5|-55.6|<0.001
70890457|NCT00767000|141266706|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-26.7||||0.005||95.0|-45.4|-8.1|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||-8.1|-45.4|0.005
70890458|NCT00767000|141266706|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-35.0|||<|0.001||95.0|-54.0|-16.0|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||-16.0|-54.0|<0.001
70890459|NCT00767000|141266706|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-36.9|||<|0.001||95.0|-55.9|-17.9|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||-17.9|-55.9|<0.001
70890460|NCT00767000|141266707|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.8||||0.791||95.0|-11.6|15.2|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||15.2|-11.6|0.791
70890461|NCT00767000|141266707|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|10.3||||0.121||95.0|-2.7|23.2|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||23.2|-2.7|0.121
70890462|NCT00767000|141266707|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-9.3||||0.169||95.0|-22.6|4.0|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||4.0|-22.6|0.169
70890463|NCT00767000|141266707|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.7||||0.321||95.0|-6.6|20.0|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||20.0|-6.6|0.321
70890464|NCT02039505|141266721|SUPERIORITY||Adjusted Odds Ratio|1.37||||0.2722|TWO_SIDED|95.0|0.779|2.399|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel (CMH) test was used for analysis. Prior tumor necrosis factor alpha (TNFα) antagonist use (yes/no) was used as stratification factor.|||2.399|0.779|0.2722
70890465|NCT02039505|141266722|SUPERIORITY||Adjusted Odds Ratio|2.88||||0.021|TWO_SIDED|95.0|1.168|7.108|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||7.108|1.168|0.0210
70890466|NCT02039505|141266728|SUPERIORITY||Adjusted Odds Ratio|1.66||||0.198|TWO_SIDED|95.0|0.762|3.596|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||3.596|0.762|0.1980
70890467|NCT02039505|141266729|SUPERIORITY||Adjusted Odds Ratio|1.33||||0.3168|TWO_SIDED|95.0|0.755|2.356|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||2.356|0.755|0.3168
70890468|NCT02039505|141266730|SUPERIORITY||Adjusted Odds Ratio|3.48||||0.0067|TWO_SIDED|95.0|1.407|8.626|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||8.626|1.407|0.0067
70890469|NCT02039505|141266731|SUPERIORITY||Adjusted Odds Ratio|3.49||||0.0066|TWO_SIDED|95.0|1.409|8.642|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||8.642|1.409|0.0066
70890470|NCT02039505|141266732|SUPERIORITY||Adjusted Odds Ratio|2.02||||0.209|TWO_SIDED|95.0|0.677|6.033|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||6.033|0.677|0.2090
70890471|NCT02039505|141266733|SUPERIORITY||Adjusted Odds Ratio|3.38||||0.1571|TWO_SIDED|95.0|0.636|17.981|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||17.981|0.636|0.1571
70890472|NCT00097591|141266743|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.002|TWO_SIDED|95.0|0.726|0.927||The primary outcome measure was analyzed first in the UA/NSTEMI population, followed by All ACS subjects, followed by the STEMI population.|Gehan-Wilcoxon|||For UA/NSTEMI population||0.927|0.726|0.002
70890473|NCT00097591|141266743|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.793||||0.019|TWO_SIDED|95.0|0.649|0.968|||Gehan-Wilcoxon|||For STEMI population||0.968|0.649|0.019
70890474|NCT00097591|141266743|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.812|||<|0.001|TWO_SIDED|95.0|0.732|0.902|||Gehan-Wilcoxon|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For All ACS population||0.902|0.732|<0.001
70890475|NCT00097591|141266744|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.314||||0.002|TWO_SIDED|95.0|1.107|1.559|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For non-CABG TIMI Major or Minor Bleeding||1.559|1.107|0.002
70890476|NCT00097591|141266744|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.315||||0.029|TWO_SIDED|95.0|1.028|1.683|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For non-CABG TIMI Major Bleeding||1.683|1.028|0.029
70890477|NCT00097591|141266744|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.517||||0.015|TWO_SIDED|95.0|1.083|2.126|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - Life-threatening events (LT)||2.126|1.083|0.015
70890478|NCT00097591|141266744|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.191||||0.002|TWO_SIDED|95.0|1.158|11.113|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - LT - Fatal||11.113|1.1580|0.002
70890479|NCT00097591|141266744|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.119||||0.736|TWO_SIDED|95.0|0.582|2.152|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - LT - Symptomatic intracranial hemorrage (ICH)||2.152|0.582|0.736
70890480|NCT00097591|141266744|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.617||||0.016|TWO_SIDED|95.0|1.159|5.908|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - LT - Requiring inotropes||5.908|1.159|0.016
70890481|NCT00097591|141266744|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.998||||0.995|TWO_SIDED|95.0|0.528|1.885|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - LT - Requiring surgical intervention||1.885|0.528|0.995
70890482|NCT00097591|141266744|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.499||||0.084|TWO_SIDED|95.0|0.945|2.379|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - LT - Requiring transfusion (\>=4 units)||2.379|0.945|0.084
70890483|NCT00097591|141266744|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.313||||0.022|TWO_SIDED|95.0|1.04|1.656|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Minor Bleeding||1.656|1.040|0.022
70890484|NCT00097591|141266745|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.784|||<|0.001|TWO_SIDED|95.0|0.688|0.894|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||Through 30 days||0.894|0.688|<0.001
70890485|NCT00097591|141266745|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.794|||<|0.001|TWO_SIDED|95.0|0.703|0.896|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||Through 90 days||0.896|0.703|<0.001
70890486|NCT00097591|141266746|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.767|||<|0.001|TWO_SIDED|95.0|0.672|0.876|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||Through 30 days||0.876|0.672|<0.001
70890487|NCT00097591|141266746|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.797|||<|0.001|TWO_SIDED|95.0|0.705|0.901|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||Through 90 days||0.901|0.705|<0.001
70890488|NCT00097591|141266747|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.838|||<|0.001|TWO_SIDED|95.0|0.762|0.921|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||||0.921|0.762|<0.001
70890489|NCT00097591|141266748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.831|||<|0.001|TWO_SIDED|95.0|0.751|0.919|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||||0.919|0.751|<0.001
70890490|NCT03017508|141266749|SUPERIORITY||Mean Difference (Final Values)|-8.34|STANDARD_DEVIATION|18.34||0.056|TWO_SIDED||||||t-test, 2 sided|||Paired t-test on VAS scores during speech comparing sublingual riluzole to placebo||||0.056
70890491|NCT01381172|141266782|OTHER|The primary analysis employed a Bayesian repeated measures linear model to estimate group differences in mean pVO2 at 24 weeks from baseline, with 30% borrowing of information (70% down-weighting) from the corresponding treatment group difference observed in the FIX-5 study subgroup. The Bayesian posterior probability would need to be \> 0.975 to be considered a positive result with statistical significance.||||||0.975||||||The posterior probability (Pr) that the mean difference in pVO2 (Δ3) between device and control groups is greater than zero must exceed 0.975 to meet the primary effectiveness endpoint.|Bayesian posterior probability|||The FIX-HF-5C Study was a study designed to confirm the preliminary evidence reported in the FIX-HF-5 subgroup analysis demonstrating improvement in subjects with LVEF 25-45% and NYHA class III-IV. A Bayesian statistical approach was employed to leverage the data available, particularly the pVO2 results, from the FIX-HF-5 subgroup.||||0.975
70890492|NCT00718042|141266790|SUPERIORITY_OR_OTHER||Specificity|99.86|||||TWO_SIDED|95.0|99.79|99.91|||Point Estimate||Numerator = All blood donors tested nonreactive from all True Negative blood donors (16,223) Denominator = All True Negative blood donors (16,246) True Negative excludes donor specimens positive by supplemental testing (3)|||99.91|99.79|
70890493|NCT00718042|141266792|SUPERIORITY_OR_OTHER||Point estimate|100.0|||||TWO_SIDED|95.0|96.7|100.0|||Sensitivity|||||100.00|96.70|
70890494|NCT00718042|141266795|SUPERIORITY_OR_OTHER||Percentage|99.1|||||TWO_SIDED|95.0|97.4|99.8|||Percentage Negative|||||99.8|97.4|
70890495|NCT00575588|141266799|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.053|||TWO_SIDED|95.0|-0.05|0.16||||||||0.16|-0.05|
70890496|NCT00575588|141266800|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-33.2|||<|0.0001|TWO_SIDED|95.0|-38.1|-28.5||Between group comparison significant after controlling overall alpha of the study|Fisher Exact|||||-28.5|-38.1|<0.0001
70890497|NCT00575588|141266801|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001||95.0|-2.7|-1.7||Between group comparison significant after controlling overall alpha of the study|ANCOVA|||||-1.7|-2.7|<0.0001
70890498|NCT00575588|141266802|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.001||0.04|TWO_SIDED|95.0|-0.0046|-0.0001||Between group comparison significant after controlling overall alpha of the study|Mixed Models Analysis|||||-0.0001|-0.0046|0.040
70890499|NCT00575588|141266803|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.059|||TWO_SIDED|95.0|-0.17|0.06|||Repeated Measures|||||0.06|-0.17|
70890500|NCT00575588|141266804|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.9|||||TWO_SIDED|95.0|-39.8|-30.0||||||||-30.0|-39.8|
70890501|NCT00575588|141266805|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.76|STANDARD_ERROR_OF_MEAN|0.286|||TWO_SIDED|95.0|-3.32|-2.2|||Repeated Measures|||||-2.20|-3.32|
70890502|NCT00575588|141266806|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0035|STANDARD_ERROR_OF_MEAN|0.0007|||TWO_SIDED|95.0|-0.0048|-0.0022|||Mixed Models Analysis|||||-0.0022|-0.0048|
70890503|NCT00614939|141266807|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.151||0.007|TWO_SIDED|95.0|-0.71|-0.12|||ANCOVA|\*Adjusted for baseline HbA1c||||-0.12|-0.71|0.007
70890504|NCT00614939|141266808|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.34|STANDARD_ERROR_OF_MEAN|12.847||0.339||95.0|-37.91|13.22|||ANCOVA|\*Adjusted for baseline FPG||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||13.22|-37.91|0.339
70890505|NCT00614939|141266809|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.36|STANDARD_ERROR_OF_MEAN|16.938||0.798|TWO_SIDED|95.0|-38.65|29.93|||ANCOVA|\*Adjusted for baseline FPG||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||29.93|-38.65|0.798
70890506|NCT00614939|141266810|SUPERIORITY_OR_OTHER||Mean Difference (Net)|44.01|STANDARD_ERROR_OF_MEAN|30.815||0.164|TWO_SIDED|95.0|-18.93|106.94|||ANCOVA|\*Adjusted for baseline FPG||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||106.94|-18.93|0.164
70890507|NCT00614939|141266811|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.68|STANDARD_ERROR_OF_MEAN|0.713|||TWO_SIDED|95.0|-2.1|0.74|||Footnote|\*Adjusted for baseline FPG||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||0.74|-2.10|
70890508|NCT00614939|141266812|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.941|||TWO_SIDED|95.0|-2.14|1.67|||Footnote|\*Adjusted for baseline FPG||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||1.67|-2.14|
70890509|NCT00614939|141266813|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.44|STANDARD_ERROR_OF_MEAN|1.709|||TWO_SIDED|95.0|-1.05|5.93|||Footnote|\*Adjusted for baseline FPG||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||5.93|-1.05|
70890510|NCT00614939|141266814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.82|STANDARD_ERROR_OF_MEAN|0.228|||TWO_SIDED|95.0|-1.27|-0.37|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=26 for saxagliptin and n=34 for placebo~\*Adjusted for baseline HbA1c"||||-0.37|-1.27|
70890511|NCT00614939|141266815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.98|STANDARD_ERROR_OF_MEAN|18.475|||TWO_SIDED|95.0|-54.28|18.33|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=17 for saxagliptin and n=16 for placebo~\*Adjusted for baseline FPG"||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||18.33|-54.28|
70890512|NCT00614939|141266816|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.73|STANDARD_ERROR_OF_MEAN|25.326|||TWO_SIDED|95.0|-65.77|34.3|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=5 for saxagliptin and n=11 for placebo.~\*Adjusted for baseline FPG"||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||34.30|-65.77|
70890513|NCT00614939|141266817|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-38.09|STANDARD_ERROR_OF_MEAN|53.822|||TWO_SIDED|95.0|-144.44|68.26|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=2 for saxagliptin and n=5 for placebo.~\*Adjusted for baseline FPG"||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||68.26|-144.44|
70890514|NCT00614939|141266818|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.97|STANDARD_ERROR_OF_MEAN|1.027|||TWO_SIDED|95.0|-2.99|1.04|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=17 for saxagliptin and n=16 for placebo.~\*Adjusted for baseline FPG"||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||1.04|-2.99|
70890515|NCT00614939|141266819|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.89|STANDARD_ERROR_OF_MEAN|1.405|||TWO_SIDED|95.0|-3.66|1.89|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=5 for saxagliptin and n=11 for placebo.~\*Adjusted for baseline FPG"||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||1.89|-3.66|
70890516|NCT00614939|141266820|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.14|STANDARD_ERROR_OF_MEAN|2.985|||TWO_SIDED|95.0|-8.04|3.76|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=2 for saxagliptin and n=5 for placebo.~\*Adjusted for baseline FPG"||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||3.76|-8.04|
70890517|NCT01854827|141266829|SUPERIORITY|Percent was evaluated relative to 80% where statistical superiority was demonstrated if the one-sided, 90% Clopper-Pearson lower confidence bound was \> 80%.|Percent of patients|79.3|||||ONE_SIDED|90.0|63.2||||||||The lower bound of the 90% Clopper-Pearson confidence interval was \< 80%, therefore the study failed to achieve the feasibility definition stated in the protocol.||63.2|
70890518|NCT01854827|141266830|SUPERIORITY|Percent was evaluated relative to 80% where statistical superiority was demonstrated if the one-sided, 90% Clopper-Pearson lower confidence bound was \> 80%.|Percent of patients|79.3|||||ONE_SIDED|90.0|63.2||||||||The lower bound of the 90% Clopper-Pearson confidence interval was \< 80%, therefore the study failed to achieve the feasibility definition stated in the protocol.||63.2|
70890519|NCT01854827|141266831|OTHER|Percents with serious AEs prior to liver transplant were calculated, along with one-sided 90% Clopper-Pearson confidence interval lower bounds.|Percent of patients|89.7|||||ONE_SIDED|90.0|75.4||||||||||75.4|
70890520|NCT01854827|141266832|OTHER|Percent of patients with level 3-5 toxicity are presented along with one-sided 90% Clopper-Pearson confidence interval lower bound.|Percent of patients|89.7|||||ONE_SIDED|90.0|75.4||||||||||75.4|
70890521|NCT01854827|141266833|OTHER|Percent of patients with other expected AEs are presented along with one-sided 90% Clopper-Pearson confidence limit lower bound.|Percent of patients|27.6|||||ONE_SIDED|90.0|14.5||||||||||14.5|
70890522|NCT01854827|141266834|SUPERIORITY|One-sided testing for superiority of IVIG to historical control.|Odds Ratio (OR)|0.67||||0.5486|ONE_SIDED|90.0||2.38|||Regression, Logistic|||IVIG was compared to the historical placebo control from the START study (n=64): PMID: 24794368 NCT00294684||2.38||0.5486
70890523|NCT01854827|141266835|SUPERIORITY|One-sided testing for superiority of IVIG relative to historical control.|Odds Ratio (OR)|0.33||||0.8455|ONE_SIDED|90.0||1.22|||Regression, Logistic|||IVIG was compared for superiority to the historical control of START study placebo (N=64). PMID: 24794368 NCT00294684||1.22||0.8455
70890524|NCT01854827|141266836|SUPERIORITY|One-sided.|Odds Ratio (OR)|0.29||||0.8431|ONE_SIDED|90.0||1.24||One-sided|Regression, Logistic|||IVIG was compared for superiority to the historical START placebo control (N=64).||1.24||0.8431
70890525|NCT01854827|141266837|SUPERIORITY|One-sided for IVIG superior to historical START placebo control. PMID: 24794368 NCT00294684|Risk Difference (RD)|-11.9|||||ONE_SIDED|90.0||2.1||||||K-M estimates for survival for IVIG vs the historical START placebo control are provided, along with one-sided 90% upper bounds of the confidence intervals.||2.1||
70890526|NCT02571452|141266839|SUPERIORITY||Mean Difference (Net)|-3.6|STANDARD_ERROR_OF_MEAN|1.53||0.021|TWO_SIDED|95.0|-6.65|-0.55||The threshold for statistical significance was p=.05.|Mixed Models Analysis|||||-0.55|-6.65|.021
70890527|NCT02571452|141266840|SUPERIORITY||Mean Difference (Net)|0.52|STANDARD_ERROR_OF_MEAN|0.57||0.568|TWO_SIDED|95.0|-1.26|2.3||The threshold for statistical significance was p=.05.|Mixed Models Analysis|||||2.30|-1.26|.568
70890528|NCT02571452|141266841|SUPERIORITY||Mean Difference (Net)|-4.1|STANDARD_ERROR_OF_MEAN|0.89|<|0.001|TWO_SIDED|95.0|-5.87|-2.33||The threshold for statistical significance was p=.05.|Mixed Models Analysis|||||-2.33|-5.87|<.001
70890529|NCT02571452|141266842|SUPERIORITY||Mean Difference (Net)|-0.66|STANDARD_ERROR_OF_MEAN|0.49||0.173|TWO_SIDED|95.0|-1.61|0.29||The threshold for statistical significance was p=.05.|Mixed Models Analysis|||||0.29|-1.61|.173
70890530|NCT02660944|141266850|SUPERIORITY|Two-sample t-test with Satterthwaite approximation|Mean Difference (Final Values)|0.37||||0.845|TWO_SIDED|95.0|-3.42|4.15|||t-test, 2 sided|||Change from baseline at Day 85 RSLV-132 versus placebo||4.15|-3.42|0.845
70890531|NCT02660944|141266850|SUPERIORITY|Two-sample t-test with Satterthwaite approximation|Mean Difference (Final Values)|-0.48||||0.818|TWO_SIDED|95.0|-4.66|3.7|||t-test, 2 sided|||Change from baseline at Day 169 RSLV-132 versus placebo||3.70|-4.66|0.818
70890532|NCT00833924|141266857|SUPERIORITY_OR_OTHER||Rate of 30-day freedom from MAE|99.2|||<|0.01|TWO_SIDED|95.0|95.4|100.0|||Exact binomial test|||Null hypothesis: The 30-day Freedom from MAE for patients treated with the Zenith® Low Profile AAA Endovascular Graft does not meet the performance goal (88%).||100|95.4|<0.01
70890533|NCT00833924|141266858|SUPERIORITY_OR_OTHER||12-month Device Success Rate|97.3|||<|0.01|TWO_SIDED|95.0|92.4|99.4|||Exact binomial test|||Null hypothesis: The 12-month device success for patients treated with the Zenith® Low Profile AAA Endovascular Graft does not meet the performance goal (84%).||99.4|92.4|<0.01
70890534|NCT01485861|141266862|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.77||||0.1606|TWO_SIDED|90.0|0.56|1.04|||Log Rank|||||1.04|0.56|0.1606
70890535|NCT01485861|141266862|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.89||||0.53|TWO_SIDED|90.0|0.66|1.2|||Log Rank|||||1.20|0.66|0.5300
70890536|NCT01485861|141266862|SUPERIORITY|Strata are: prior enzalutamide (Yes vs. No), progression factor (prostate-specific antigen \[PSA\] only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).|Hazard Ratio (HR)|0.75||||0.1689|TWO_SIDED|90.0|0.54|1.05|||Log Rank|||||1.05|0.54|0.1689
70890537|NCT01485861|141266862|SUPERIORITY|Strata are: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).|Hazard Ratio (HR)|0.94||||0.7484|TWO_SIDED|90.0|0.69|1.28|||Log Rank|||||1.28|0.69|0.7484
70890538|NCT01485861|141266863|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.39||||0.0064|TWO_SIDED|90.0|0.22|0.7|||Log Rank|||||0.70|0.22|0.0064
70890539|NCT01485861|141266863|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.46||||0.0285|TWO_SIDED|90.0|0.25|0.83|||Log Rank|||||0.83|0.25|0.0285
70890540|NCT01485861|141266881|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.87||||0.417|TWO_SIDED|95.0|0.62|1.22|||Log Rank|||||1.22|0.62|0.4170
70890541|NCT01485861|141266881|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.93||||0.6712|TWO_SIDED|95.0|0.67|1.3|||Log Rank|||||1.30|0.67|0.6712
70890542|NCT01485861|141266881|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.5164|TWO_SIDED|95.0|0.62|1.27|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||1.27|0.62|0.5164
70890543|NCT01485861|141266881|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.8955|TWO_SIDED|95.0|0.72|1.44|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||1.44|0.72|0.8955
70890544|NCT01485861|141266882|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.63||||0.1472|TWO_SIDED|95.0|0.33|1.19|||Log Rank|||||1.19|0.33|0.1472
70890545|NCT01485861|141266882|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.45||||0.0157|TWO_SIDED|95.0|0.23|0.87|||Log Rank|||||0.87|0.23|0.0157
70890546|NCT01485861|141266885|SUPERIORITY||Hazard Ratio (HR)|0.7|||=|0.0665|TWO_SIDED|90.0|0.51|0.97|||Log Rank|||||0.97|0.51|= 0.0665
70890547|NCT01485861|141266885|SUPERIORITY||Hazard Ratio (HR)|0.99|||=|0.9319|TWO_SIDED|90.0|0.73|1.33|||Log Rank|||||1.33|0.73|= 0.9319
70890548|NCT01485861|141266885|SUPERIORITY||Hazard Ratio (HR)|0.7|||=|0.071|TWO_SIDED|90.0|0.5|0.97|||Log Rank|||Strata were: prior Enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||0.97|0.50|= 0.0710
70890549|NCT01485861|141266885|SUPERIORITY||Hazard Ratio (HR)|0.95|||=|0.789|TWO_SIDED|90.0|0.7|1.31|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||1.31|0.70|= 0.7890
70890550|NCT01485861|141266886|SUPERIORITY||Hazard Ratio (HR)|0.68|||=|0.2906|TWO_SIDED|90.0|0.37|1.25|||Log Rank|||||1.25|0.37|= 0.2906
70890551|NCT01485861|141266886|SUPERIORITY||Hazard Ratio (HR)|0.65|||=|0.2716|TWO_SIDED|90.0|0.35|1.22|||Log Rank|||||1.22|0.35|= 0.2716
70890552|NCT01485861|141266887|SUPERIORITY|Unstratified|Difference in response rates|1.97|||=|0.7913|TWO_SIDED|90.0|-10.25|14.18|||Chi-squared|||||14.18|-10.25|= 0.7913
70890553|NCT01485861|141266887|SUPERIORITY|Unstratified|Difference in response rates|-1.22|||=|0.8675|TWO_SIDED|90.0|-13.24|10.8|||Chi-squared|||||10.80|-13.24|= 0.8675
70890554|NCT01485861|141266888|SUPERIORITY||Difference in response rates|11.43|||=|0.4176|TWO_SIDED|90.0|-11.43|58.32|||Chi-squared|||||58.32|-11.43|= 0.4176
70890555|NCT01485861|141266888|SUPERIORITY||Difference in response rates|15.43|||=|0.2802|TWO_SIDED|90.0|-7.58|38.44|||Chi-squared|||||38.44|-7.58|= 0.2802
70890556|NCT01485861|141266889|SUPERIORITY||Difference in response rates|9.58|||=|0.3646|TWO_SIDED|90.0|-7.65|26.8|||Chi-squared|||||26.80|-7.65|= 0.3646
70890557|NCT01485861|141266889|SUPERIORITY||Difference in response rates|0.22|||=|0.9821|TWO_SIDED|90.0|-15.89|16.33|||Chi-squared|||||16.33|-15.89|= 0.9821
70890558|NCT01485861|141266890|SUPERIORITY||Difference in response rates|-3.17|||=|0.8489|TWO_SIDED|90.0|-30.93|24.58|||Chi-squared|||||24.58|-30.93|= 0.8489
70890559|NCT01485861|141266890|SUPERIORITY||Difference in response rates|12.38|||=|0.5186|TWO_SIDED|90.0|-16.36|41.12|||Chi-squared|||||41.12|-16.36|= 0.5186
70890560|NCT01485861|141266891|SUPERIORITY|Unstratified|Hazard Ratio (HR)|1.31|||=|0.678|TWO_SIDED|90.0|0.45|3.8|||Log Rank|||||3.80|0.45|= 0.6780
70890561|NCT01485861|141266891|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.85|||=|0.8372|TWO_SIDED|90.0|0.24|3.02|||Log Rank|||||3.02|0.24|= 0.8372
70890562|NCT01485861|141266891|SUPERIORITY||Hazard Ratio (HR)|0.77|||=|0.7733|TWO_SIDED|90.0|0.17|3.5|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||3.50|0.17|= 0.7733
70890563|NCT01485861|141266891|SUPERIORITY||Hazard Ratio (HR)|2.46|||=|0.4227|TWO_SIDED|90.0|0.36|16.59|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||16.59|0.36|= 0.4227
70890564|NCT01485861|141266892|SUPERIORITY||Hazard Ratio (HR)|999.99|||=|0.3173|TWO_SIDED|90.0|0.0||NA = Not estimable due to limited number of events observed||Log Rank||\>||||0.00|= 0.3173
70890565|NCT01485861|141266892|SUPERIORITY||Hazard Ratio (HR)|999.99|||=|0.6171|TWO_SIDED|90.0|0.0||NA = Not estimable due to limited number of events observed||Log Rank||\>||||0.00|= 0.6171
70890566|NCT01485861|141266893|SUPERIORITY||Difference in response rates|3.75|||=|0.6652|TWO_SIDED|90.0|-10.47|17.97|||Chi-squared|||||17.97|-10.47|= 0.6652
70890567|NCT01485861|141266893|SUPERIORITY||Difference in response rates|7.48|||=|0.3734|TWO_SIDED|90.0|-6.29|21.24|||Chi-squared|||||21.24|-6.29|= 0.3734
70890568|NCT01485861|141266894|SUPERIORITY||Difference in response rates|4.41|||=|0.7633|TWO_SIDED|90.0|-19.76|28.58|||Chi-squared|||||28.58|-19.76|= 0.7633
70890569|NCT01485861|141266894|SUPERIORITY||Difference in response rates|4.41|||=|0.7633|TWO_SIDED|90.0|-19.76|28.58|||Chi-squared|||||28.58|-19.76|= 0.7633
70890570|NCT01485861|141266895|SUPERIORITY||Difference in response rates|2.24|||=|0.8317|TWO_SIDED|90.0|-15.07|19.54|||Chi-squared|||||19.54|-15.07|= 0.8317
70890571|NCT01485861|141266895|SUPERIORITY||Difference in response rates|5.14|||=|0.6139|TWO_SIDED|90.0|-11.6|21.88|||Chi-squared|||||21.88|-11.60|= 0.6139
70890572|NCT01485861|141266896|SUPERIORITY||Difference in response rates|34.85|||=|0.0505|TWO_SIDED|90.0|7.14|62.56|||Chi-squared|||||62.56|7.14|= 0.0505
70890573|NCT01485861|141266896|SUPERIORITY||Difference in response rates|-9.6|||=|0.4989|TWO_SIDED|90.0|-32.54|13.35|||Chi-squared|||||13.35|-32.54|= 0.4989
70890574|NCT01485861|141266899|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.95|||=|0.8483|TWO_SIDED|90.0|0.61|1.47|||Log Rank|||||1.47|0.61|= 0.8483
70890575|NCT01485861|141266899|SUPERIORITY|Unstratified|Hazard Ratio (HR)|1.08|||=|0.785|TWO_SIDED|90.0|0.7|1.65|||Log Rank|||||1.65|0.70|= 0.7850
70890576|NCT01485861|141266899|SUPERIORITY||Hazard Ratio (HR)|1.04|||=|0.8847|TWO_SIDED|90.0|0.66|1.65|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||1.65|0.66|= 0.8847
70890577|NCT01485861|141266899|SUPERIORITY||Hazard Ratio (HR)|1.05|||=|0.8647|TWO_SIDED|90.0|0.67|1.63|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||1.63|0.67|= 0.8647
70890578|NCT01485861|141266900|SUPERIORITY||Hazard Ratio (HR)|0.89|||=|0.8271|TWO_SIDED|90.0|0.39|2.06|||Log Rank|||||2.06|0.39|= 0.8271
70890579|NCT01485861|141266900|SUPERIORITY||Hazard Ratio (HR)|0.84|||=|0.7383|TWO_SIDED|90.0|0.35|2.02|||Log Rank|||||2.02|0.35|= 0.7383
70890580|NCT01144338|141266908|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|0.91||||0.061|TWO_SIDED|95.0|0.832|1.004|||Regression, Cox|||||1.004|0.832|0.061
70890581|NCT01144338|141266909|NON_INFERIORITY|Non-inferiority test of EQW over Placebo H0: HR ≥ 1.3 vs. H1: HR \< 1.3|Hazard Ratio (HR)|0.91|||<|0.001|TWO_SIDED|95.0|0.832|1.004|||Regression, Cox|||This analysis uses the same endpoint and cox regression method as the primary efficacy analysis. However, the statistical hypothesis is a non-inferiority test with a margin of HR=1.3.||1.004|0.832|< 0.001
70890582|NCT01144338|141266910|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|0.86||||0.016|TWO_SIDED|95.0|0.77|0.97|||Regression, Cox|||||0.97|0.77|0.016
70890583|NCT01144338|141266911|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|0.88||||0.096|TWO_SIDED|95.0|0.76|1.02|||Regression, Cox|||||1.02|0.76|0.096
70890584|NCT01144338|141266912|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|0.97||||0.622|TWO_SIDED|95.0|0.85|1.1|||Regression, Cox|||||1.10|0.85|0.622
70890585|NCT01144338|141266913|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|0.85||||0.095|TWO_SIDED|95.0|0.7|1.03|||Regression, Cox|||||1.03|0.70|0.095
70890586|NCT01144338|141266914|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|1.05||||0.402|TWO_SIDED|95.0|0.94|1.18|||Regression, Cox|||||1.18|0.94|0.402
70890587|NCT01144338|141266915|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|0.94||||0.485|TWO_SIDED|95.0|0.78|1.13|||Regression, Cox|||||1.13|0.78|0.485
70890588|NCT04796610|141266916|SUPERIORITY||Odds Ratio (OR)|0.55||||0.49|TWO_SIDED|95.0|0.1|2.98|||Regression, Logistic|Model is adjusted for participant age|Results are presented for an indicator where 0=control and 1=intervention|||2.98|.1|0.49
70890589|NCT04796610|141266917|SUPERIORITY||Odds Ratio (OR)|16.82||||0.011|TWO_SIDED|95.0|1.93|146.91||Model is adjusted for participant age|Regression, Logistic||Results are presented for an indicator where 0=control and 1=intervention|||146.91|1.93|.011
70890590|NCT04796610|141266918|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.03|TWO_SIDED|95.0|0.07|0.97|||Regression, Linear|Model is adjusted for participant age|Results are presented for an indicator where 0=control and 1=intervention|||0.97|0.07|.03
70890591|NCT02059148|141266919|SUPERIORITY_OR_OTHER||Ratio of Geometric LSMeans|1.24|||||TWO_SIDED|90.0|1.11|1.38||||||||1.38|1.11|
70890592|NCT02059148|141266920|SUPERIORITY_OR_OTHER||Ratio of Geometric LSMeans|1.14|||||TWO_SIDED|90.0|1.05|1.23||||||||1.23|1.05|
70890593|NCT02059148|141266921|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.95||||0.0006|TWO_SIDED|90.0|1.0|2.0|||Wilcoxon (Mann-Whitney)|||||2.00|1.00|0.0006
70890594|NCT00403546|141266929|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.98|TWO_SIDED|95.0|-1.09|1.12|||Mixed Models Analysis|||At Baseline||1.12|-1.09|0.980
70890595|NCT00403546|141266929|SUPERIORITY||Mean Difference (Net)|1.02||||0.033|TWO_SIDED|95.0|0.08|1.95|||Mixed Models Analysis|||At Week 2||1.95|0.08|0.033
70890596|NCT00403546|141266929|SUPERIORITY||Mean Difference (Net)|0.73||||0.171|TWO_SIDED|95.0|-0.32|1.77|||Mixed Models Analysis|||At Week 4||1.77|-0.32|0.171
70890597|NCT00403546|141266929|SUPERIORITY||Mean Difference (Net)|0.5||||0.38|TWO_SIDED|95.0|-0.62|1.62|||Mixed Models Analysis|||At Week 6||1.62|-0.62|0.380
70890598|NCT00403546|141266929|SUPERIORITY||Mean Difference (Net)|-0.12||||0.84|TWO_SIDED|95.0|-1.32|1.08|||Mixed Models Analysis|||At Week 8||1.08|-1.32|0.840
70890599|NCT00403546|141266930|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.737|TWO_SIDED|95.0|-1.23|0.88|||Mixed Models Analysis|||At Baseline||0.88|-1.23|0.737
70890600|NCT00403546|141266930|SUPERIORITY||Mean Difference (Net)|-0.14||||0.764|TWO_SIDED|95.0|-1.09|0.8|||Mixed Models Analysis|||At Week 2||0.80|-1.09|0.764
70890601|NCT00403546|141266930|SUPERIORITY||Mean Difference (Net)|0.25||||0.642|TWO_SIDED|95.0|-0.82|1.32|||Mixed Models Analysis|||At Week 4||1.32|-0.82|0.642
70890602|NCT00403546|141266930|SUPERIORITY||Mean Difference (Net)|-0.34||||0.57|TWO_SIDED|95.0|-1.5|0.83|||Mixed Models Analysis|||At Week 6||0.83|-1.50|0.570
70890603|NCT00403546|141266930|SUPERIORITY||Mean Difference (Net)|-0.09||||0.894|TWO_SIDED|95.0|-1.34|1.17|||Mixed Models Analysis|||At Week 8||1.17|-1.34|0.894
70890604|NCT00403546|141266932|SUPERIORITY||Mean Difference (Net)|-1.82||||0.599|TWO_SIDED|95.0|-8.68|5.05|||Mixed Models Analysis|||SBP at Baseline||5.05|-8.68|0.599
70890605|NCT00403546|141266932|SUPERIORITY||Mean Difference (Net)|3.53||||0.235|TWO_SIDED|95.0|-2.31|9.37|||Mixed Models Analysis|||SBP at Week 1||9.37|-2.31|0.235
70890606|NCT00403546|141266932|SUPERIORITY||Mean Difference (Net)|2.83||||0.449|TWO_SIDED|95.0|-3.8|8.57|||Mixed Models Analysis|||SBP at Week 2||8.57|-3.80|0.449
70890607|NCT00403546|141266932|SUPERIORITY||Mean Difference (Net)|3.64||||0.301|TWO_SIDED|95.0|-3.28|10.56|||Mixed Models Analysis|||SBP at Week 4||10.56|-3.28|0.301
70890608|NCT00403546|141266932|SUPERIORITY||Mean Difference (Net)|-0.75||||0.842|TWO_SIDED|95.0|-8.13|6.63|||Mixed Models Analysis|||SBP at Week 6||6.63|-8.13|0.842
70890609|NCT00403546|141266932|SUPERIORITY||Mean Difference (Net)|6.33||||0.109|TWO_SIDED|95.0|-1.43|14.09|||Mixed Models Analysis|||SBP at Week 8||14.09|-1.43|0.109
70890610|NCT00403546|141266932|SUPERIORITY||Mean Difference (Net)|-0.8||||0.741|TWO_SIDED|95.0|-5.62|4.02|||Mixed Models Analysis|||DBP at Baseline||4.02|-5.62|0.741
70890611|NCT00403546|141266932|SUPERIORITY||Mean Difference (Net)|1.44||||0.552|TWO_SIDED|95.0|-3.32|6.19|||Mixed Models Analysis|||DBP at Week 1||6.19|-3.32|0.552
70890612|NCT00403546|141266932|SUPERIORITY||Mean Difference (Net)|2.83||||0.268|TWO_SIDED|95.0|-2.18|7.84|||Mixed Models Analysis|||DBP at Week 2||7.84|-2.18|0.268
70890613|NCT00403546|141266932|SUPERIORITY||Mean Difference (Net)|1.02||||0.719|TWO_SIDED|95.0|-4.53|6.56|||Mixed Models Analysis|||DBP at Week 4||6.56|-4.53|0.719
70890614|NCT00403546|141266932|SUPERIORITY||Mean Difference (Net)|-2.86||||0.334|TWO_SIDED|95.0|-8.68|2.96|||Mixed Models Analysis|||DBP at Week 6||2.96|-8.68|0.334
70890615|NCT00403546|141266932|SUPERIORITY||Mean Difference (Net)|4.38||||0.151|TWO_SIDED|95.0|-1.61|10.37|||Mixed Models Analysis|||DBP at Week 8||10.37|-1.61|0.151
70890616|NCT00403546|141266934|SUPERIORITY||Mean Difference (Final Values)|2.77||||0.416|TWO_SIDED|95.0|-3.97|9.5|||Mixed Models Analysis|Mixed models analysis with random slopes||At Baseline||9.50|-3.97|0.416
70890617|NCT00403546|141266934|SUPERIORITY||Mean Difference (Net)|0.37||||0.854|TWO_SIDED|95.0|-3.59|4.33|||Mixed Models Analysis|||At Week 2||4.33|-3.59|0.854
70890618|NCT00403546|141266934|SUPERIORITY||Mean Difference (Net)|1.95||||0.406|TWO_SIDED|95.0|-2.68|6.58|||Mixed Models Analysis|||At Week 4||6.58|-2.68|0.406
70890619|NCT00403546|141266934|SUPERIORITY||Mean Difference (Net)|-3.01||||0.256|TWO_SIDED|95.0|-8.23|2.21|||Mixed Models Analysis|||At Week 6||2.21|-8.23|0.256
70890620|NCT00403546|141266934|SUPERIORITY||Mean Difference (Net)|-1.37||||0.642|TWO_SIDED|95.0|-7.2|4.45|||Mixed Models Analysis|||At Week 8||4.45|-7.20|0.642
70890621|NCT00403546|141266936|SUPERIORITY||Mean Difference (Final Values)|-0.67||||0.135|TWO_SIDED|95.0|-1.55|0.2|||Mixed Models Analysis|||At Baseline||0.20|-1.55|0.135
70890622|NCT00403546|141266936|SUPERIORITY||Mean Difference (Net)|0.44||||0.262|TWO_SIDED|95.0|-0.33|1.21|||Mixed Models Analysis|||At Week 2||1.21|-0.33|0.262
70890623|NCT00403546|141266936|SUPERIORITY||Mean Difference (Net)|0.58||||0.209|TWO_SIDED|95.0|-0.33|1.49|||Mixed Models Analysis|||At Week 4||1.49|-0.33|0.209
70890624|NCT00403546|141266936|SUPERIORITY||Mean Difference (Net)|0.03||||0.95|TWO_SIDED|95.0|-1.01|1.07|||Mixed Models Analysis|||At Week 6||1.07|-1.01|0.950
70890625|NCT00403546|141266936|SUPERIORITY||Mean Difference (Net)|0.57||||0.34|TWO_SIDED|95.0|-0.61|1.76|||Mixed Models Analysis|||At Week 8||1.76|-0.61|0.340
70890626|NCT03893448|141266951|OTHER||Percentage Point Difference|-4.8|||=|0.039|TWO_SIDED|95.0|-9.3|-0.2|||Miettinen & Nurminen||V114-Prevnar 13™|Injection site erythema Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.2|-9.3|= 0.039
70890627|NCT03893448|141266951|OTHER||Percentage Point Difference|-0.4|||=|0.836|TWO_SIDED|95.0|-4.6|3.7|||Miettinen & Nurminen||V114-Prevnar 13™|Injection site induration Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||3.7|-4.6|= 0.836
70890628|NCT03893448|141266951|OTHER||Percentage Point Difference|2.9|||=|0.235|TWO_SIDED|95.0|-1.9|7.6|||Miettinen & Nurminen||V114-Prevnar 13™|Injection site pain Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||7.6|-1.9|= 0.235
70890629|NCT03893448|141266951|OTHER||Percentage Point Difference|2.4|||=|0.26|TWO_SIDED|95.0|-1.7|6.5|||Miettinen & Nurminen||V114-Prevnar 13™|Injection site swelling Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||6.5|-1.7|= 0.260
70890630|NCT03893448|141266952|OTHER||Percentage Point Difference|-1.8|||=|0.446|TWO_SIDED|95.0|-6.3|2.8|||Miettinen & Nurminen||V114-Prevnar 13™|Decreased appetite Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||2.8|-6.3|= 0.446
70890631|NCT03893448|141266952|OTHER||Percentage Point Difference|1.0|||=|0.622|TWO_SIDED|95.0|-3.0|5.1|||Miettinen & Nurminen||V114-Prevnar 13™|Irritability Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||5.1|-3.0|= 0.622
70890632|NCT03893448|141266952|OTHER||Percentage Point Difference|-3.0|||=|0.202|TWO_SIDED|95.0|-7.6|1.6|||Miettinen & Nurminen||V114-Prevnar 13™|Somnolence (drowsiness) Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||1.6|-7.6|= 0.202
70890633|NCT03893448|141266952|OTHER||Percentage Point Difference|0.0|||=|0.985|TWO_SIDED|95.0|-2.4|2.3|||Miettinen & Nurminen||V114-Prevnar 13™|Urticaria (Hives) Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||2.3|-2.4|= 0.985
70890634|NCT03893448|141266953|OTHER||Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.4|0.4|||||V114-Prevnar 13™|Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||0.4|-0.4|
70890635|NCT03893448|141266954|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-3.4|||<|0.001|TWO_SIDED|95.0|-5.2|-1.8||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 1 Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-1.8|-5.2|< 0.001
70890636|NCT03893448|141266954|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|15.6|||<|0.001|TWO_SIDED|95.0|12.1|19.2||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 3 Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||19.2|12.1|< 0.001
70890637|NCT03893448|141266954|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-2.2|||<|0.001|TWO_SIDED|95.0|-4.0|-0.6||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 4 Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.6|-4.0|< 0.001
70890638|NCT03893448|141266954|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-2.1|||<|0.001|TWO_SIDED|95.0|-4.2|-0.2||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 5 Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.2|-4.2|< 0.001
70890639|NCT03893448|141266954|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-4.9|||<|0.001|TWO_SIDED|95.0|-7.1|-3.0||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 6A Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-3.0|-7.1|< 0.001
70890640|NCT03893448|141266954|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-3.4|||<|0.001|TWO_SIDED|95.0|-6.6|-0.3||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 6B Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.3|-6.6|< 0.001
70890641|NCT03893448|141266954|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-0.8|||<|0.001|TWO_SIDED|95.0|-1.9|-0.1||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 7F Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.1|-1.9|< 0.001
70890642|NCT03893448|141266954|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-1.0|||<|0.001|TWO_SIDED|95.0|-2.8|0.6||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 9V Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||0.6|-2.8|< 0.001
70890643|NCT03893448|141266954|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-1.6|1.6||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 14 Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||1.6|-1.6|< 0.001
70890644|NCT03893448|141266954|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-0.9|||<|0.001|TWO_SIDED|95.0|-2.6|0.7||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 18C Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||0.7|-2.6|< 0.001
70890645|NCT03893448|141266954|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-1.8|||<|0.001|TWO_SIDED|95.0|-3.2|-0.8||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 19A Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.8|-3.2|< 0.001
70890646|NCT03893448|141266954|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-1.0|||<|0.001|TWO_SIDED|95.0|-2.1|-0.4||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 19F Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.4|-2.1|< 0.001
70890647|NCT03893448|141266954|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-0.3|||<|0.001|TWO_SIDED|95.0|-3.2|2.7||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 23F Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||2.7|-3.2|< 0.001
70890648|NCT03893448|141266954|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|6.7|||<|0.001|TWO_SIDED|95.0|4.6|9.2||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 22F This analysis represents the difference between response rate to Serotype 22F in recipients of V114 and lowest response (Serotype 23F at 91.8) in recipients of Prevnar 13™ for shared serotypes, excluding serotype 3. Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||9.2|4.6|< 0.001
70890649|NCT03893448|141266954|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-4.5|||<|0.001|TWO_SIDED|95.0|-7.8|-1.3||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 33F This analysis represents the difference between response rate to Serotype 33F in recipients of V114 and lowest response (Serotype 23F at 91.8) in recipients of Prevnar 13™ for shared serotypes, excluding serotype 3. Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-1.3|-7.8|< 0.001
70890650|NCT03893448|141266955|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.64|||<|0.001|TWO_SIDED|95.0|0.59|0.69|||t-test, 1 sided||V114/Prevnar 13™|Serotype 1 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.69|0.59|< 0.001
70890651|NCT03893448|141266955|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|1.73|||<|0.001|TWO_SIDED|95.0|1.61|1.87|||t-test, 1 sided||V114/Prevnar 13™|Serotype 3 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.87|1.61|< 0.001
70890652|NCT03893448|141266955|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.95|||<|0.001|TWO_SIDED|95.0|0.88|1.03|||t-test, 1 sided||V114/Prevnar 13™|Serotype 4 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.03|0.88|< 0.001
70890653|NCT03893448|141266955|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.72|||<|0.001|TWO_SIDED|95.0|0.66|0.8|||t-test, 1 sided||V114/Prevnar 13™|Serotype 5 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.80|0.66|< 0.001
70890654|NCT03893448|141266955|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.52|||=|0.167|TWO_SIDED|95.0|0.48|0.58|||t-test, 1 sided||V114/Prevnar 13™|Serotype 6A GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.58|0.48|= 0.167
70890655|NCT03893448|141266955|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.81|||<|0.001|TWO_SIDED|95.0|0.71|0.93|||t-test, 1 sided||V114/Prevnar 13™|Serotype 6B GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.93|0.71|< 0.001
70890656|NCT03893448|141266955|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.77|||<|0.001|TWO_SIDED|95.0|0.71|0.83|||t-test, 1 sided||V114/Prevnar 13™|Serotype 7F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.83|0.71|< 0.001
70890657|NCT03893448|141266955|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.91|||<|0.001|TWO_SIDED|95.0|0.84|1.0|||t-test, 1 sided||V114/Prevnar 13™|Serotype 9V GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.00|0.84|< 0.001
70890658|NCT03893448|141266955|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.7|||<|0.001|TWO_SIDED|95.0|0.63|0.78|||t-test, 1 sided||V114/Prevnar 13™|Serotype 14 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.78|0.63|< 0.001
70890659|NCT03893448|141266955|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.76|||<|0.001|TWO_SIDED|95.0|0.7|0.83|||t-test, 1 sided||V114/Prevnar 13™|Serotype 18C GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.83|0.70|< 0.001
70890660|NCT03893448|141266955|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.71|||<|0.001|TWO_SIDED|95.0|0.65|0.77|||t-test, 1 sided||V114/Prevnar 13™|Serotype 19A GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.77|0.65|< 0.001
70890661|NCT03893448|141266955|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.74|||<|0.001|TWO_SIDED|95.0|0.69|0.79|||t-test, 1 sided||V114/Prevnar 13™|Serotype 19F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.79|0.69|< 0.001
70890662|NCT03893448|141266955|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.89|||<|0.001|TWO_SIDED|95.0|0.8|0.99|||t-test, 1 sided||V114/Prevnar 13™|Serotype 23F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.99|0.80|< 0.001
70890663|NCT03893448|141266955|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|3.64|||<|0.001|TWO_SIDED|95.0|3.33|3.98|||t-test, 1 sided||V114/Prevnar 13™|Serotype 22F IgG GMC for Serotype 22F in recipients of V114 was compared to lowest IgG GMC (Serotype 4 at 1.35 ug/mL) for shared serotype in recipients of Prevnar 13™, excluding serotype 3. GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||3.98|3.33|< 0.001
70890664|NCT03893448|141266955|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|1.24|||<|0.001|TWO_SIDED|95.0|1.1|1.39|||t-test, 1 sided||V114/Prevnar 13™|Serotype 33F IgG GMC for Serotype 33F in recipients of V114 was compared to lowest IgG GMC (Serotype 4 at 1.35 ug/mL) for shared serotype in recipients of Prevnar 13™, excluding serotype 3. GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.39|1.10|< 0.001
70890665|NCT03893448|141266956|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.66|||<|0.001|TWO_SIDED|95.0|0.62|0.72|||t-test, 1 sided||V114/Prevnar 13™|Serotype 1 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.72|0.62|< 0.001
70890666|NCT03893448|141266956|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|1.35|||<|0.001|TWO_SIDED|95.0|1.25|1.46|||t-test, 1 sided||V114/Prevnar 13™|Serotype 3 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.46|1.25|< 0.001
70890667|NCT03893448|141266956|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.77|||<|0.001|TWO_SIDED|95.0|0.71|0.84|||t-test, 1 sided||V114/Prevnar 13™|Serotype 4 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.84|0.71|< 0.001
70890668|NCT03893448|141266956|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.63|||<|0.001|TWO_SIDED|95.0|0.58|0.69|||t-test, 1 sided||V114/Prevnar 13™|Serotype 5 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.69|0.58|< 0.001
70890669|NCT03893448|141266956|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.6|||<|0.001|TWO_SIDED|95.0|0.54|0.65|||t-test, 1 sided||V114/Prevnar 13™|Serotype 6A GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.65|0.54|< 0.001
70890670|NCT03893448|141266956|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.74|||<|0.001|TWO_SIDED|95.0|0.67|0.81|||t-test, 1 sided||V114/Prevnar 13™|Serotype 6B GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.81|0.67|< 0.001
70890671|NCT03893448|141266956|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.7|||<|0.001|TWO_SIDED|95.0|0.65|0.77|||t-test, 1 sided||V114/Prevnar 13™|Serotype 7F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.77|0.65|< 0.001
70890672|NCT03893448|141266956|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.73|||<|0.001|TWO_SIDED|95.0|0.67|0.8|||t-test, 1 sided||V114/Prevnar 13™|Serotype 9V GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.80|0.67|< 0.001
70890673|NCT03893448|141266956|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.81|||<|0.001|TWO_SIDED|95.0|0.73|0.89|||t-test, 1 sided||V114/Prevnar 13™|Serotype 14 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.89|0.73|< 0.001
70890674|NCT03893448|141266956|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.85|||<|0.001|TWO_SIDED|95.0|0.78|0.93|||t-test, 1 sided||V114/Prevnar 13™|Serotype 18C GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.93|0.78|< 0.001
70890675|NCT03893448|141266956|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.74|||<|0.001|TWO_SIDED|95.0|0.68|0.8|||t-test, 1 sided||V114/Prevnar 13™|Serotype 19A GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.80|0.68|< 0.001
70890676|NCT03893448|141266956|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.79|||<|0.001|TWO_SIDED|95.0|0.74|0.86|||t-test, 1 sided||V114/Prevnar 13™|Serotype 19F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.86|0.74|< 0.001
70890677|NCT03893448|141266956|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.61|||<|0.001|TWO_SIDED|95.0|0.56|0.68|||t-test, 1 sided||V114/Prevnar 13™|Serotype 23F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.68|0.56|< 0.001
70890678|NCT03893448|141266956|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|4.69|||<|0.001|TWO_SIDED|95.0|4.3|5.11|||t-test, 1 sided||V114/Prevnar 13™|Serotype 22F IgG GMC for Serotype 22F in recipients of V114 was compared to the lowest IgG GMC (Serotype 4 at 1.60 ug/mL) for shared serotype in recipients of Prevnar 13™, excluding serotype 3. GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||5.11|4.30|< 0.001
70890679|NCT03893448|141266956|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|2.59|||<|0.001|TWO_SIDED|95.0|2.36|2.83|||t-test, 1 sided||V114/Prevnar 13™|Serotype 33F IgG GMC for Serotype 33F in recipients of V114 was compared to the lowest IgG GMC (Serotype 4 at 1.60 ug/mL) for shared serotype in recipients of Prevnar 13™, excluding serotype 3. GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||2.83|2.36|< 0.001
70890680|NCT03893448|141266957|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|-0.7|||<|0.001|TWO_SIDED|95.0|-2.6|1.1||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Diphtheria toxoid % ≥0.1 IU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||1.1|-2.6|< 0.001
70890681|NCT03893448|141266957|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.4|0.8||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Tetanus toxoid: % ≥0.1 IU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.8|-0.4|< 0.001
70890682|NCT03893448|141266957|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|0.5|||<|0.001|TWO_SIDED|95.0|-0.7|1.9||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Pertussis toxin (PT): % ≥ 5 EU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||1.9|-0.7|< 0.001
70890683|NCT03893448|141266957|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|-0.3|||<|0.001|TWO_SIDED|95.0|-1.3|0.8||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Pertussis filamentous hemagglutinin (FHA): % ≥5 EU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.8|-1.3|< 0.001
70890684|NCT03893448|141266957|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|2.0|||<|0.001|TWO_SIDED|95.0|-3.1|7.1||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Pertussis fimbrae types 2/3 (FIM 2/3): % ≥20 EU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||7.1|-3.1|< 0.001
70890685|NCT03893448|141266957|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|1.8|||<|0.001|TWO_SIDED|95.0|-3.2|6.8||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Pertussis pertactin (PRN): % ≥5 EU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||6.8|-3.2|< 0.001
70890686|NCT03893448|141266957|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|0.8||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Poliovirus 1: % NAb ≥1:8 dilution Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.8|-0.7|< 0.001
70890687|NCT03893448|141266957|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.6|0.6||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Poliovirus 2: % NAb ≥1:8 dilution Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.6|-0.6|< 0.001
70890688|NCT03893448|141266957|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.6|0.6||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Poliovirus 3: % NAb ≥1:8 dilution Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.6|-0.6|< 0.001
70890689|NCT03893448|141266957|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|-1.4|||<|0.001|TWO_SIDED|95.0|-4.3|1.5||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Haemophilus influenzae Type B polyribosylribitol phosphate (Hib-PRP): % ≥0.15 ug/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||1.5|-4.3|< 0.001
70890690|NCT03893448|141266958|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.67 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.99|||<|0.001|TWO_SIDED|95.0|0.89|1.09|||t-test, 1 sided||V114/Prevnar 13™|Pertussis - PT GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.09|0.89|< 0.001
70890691|NCT03893448|141266958|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.67 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.98|||<|0.001|TWO_SIDED|95.0|0.87|1.09|||t-test, 1 sided||V114/Prevnar 13™|Pertussis - FHA GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.09|0.87|< 0.001
70890692|NCT03893448|141266958|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.67 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|1.08|||<|0.001|TWO_SIDED|95.0|0.91|1.28|||t-test, 1 sided||V114/Prevnar 13™|Pertussis - FIM 2/3 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.28|0.91|< 0.001
70890693|NCT03893448|141266958|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.67 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|1.0|||<|0.001|TWO_SIDED|95.0|0.84|1.19|||t-test, 1 sided||V114/Prevnar 13™|Pertussis - PRN GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.19|0.84|< 0.001
70890694|NCT03893448|141266959|NON_INFERIORITY|A conclusion of non-inferiority of VAQTA™ administered concomitantly with V114 to VAQTA™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-1.6|2.2||p value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||2.2|-1.6|< 0.001
70890695|NCT03893448|141266960|NON_INFERIORITY|A conclusion of non-inferiority of M-M-R™ II administered concomitantly with V114 to M-M-R™ II administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.8|1.3||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Measles antigen ≥255 mIU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||1.3|-1.8|< 0.001
70890696|NCT03893448|141266960|NON_INFERIORITY|A conclusion of non-inferiority of M-M-R™ II administered concomitantly with V114 to M-M-R™ II administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|-1.7|||<|0.001|TWO_SIDED|95.0|-3.8|0.2||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Mumps antigen ≥10 mumps Ab units/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.2|-3.8|< 0.001
70890697|NCT03893448|141266960|NON_INFERIORITY|A conclusion of non-inferiority of M-M-R™ II administered concomitantly with V114 to M-M-R™ II administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|-0.9|||<|0.001|TWO_SIDED|95.0|-2.3|0.5||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Rubella antigen ≥10 IU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.5|-2.3|< 0.001
70890698|NCT03893448|141266961|NON_INFERIORITY|A conclusion of non-inferiority of VARIVAX™ administered concomitantly with V114 to VARIVAX™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|-1.3|||<|0.001|TWO_SIDED|95.0|-3.2|0.5||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.5|-3.2|< 0.001
70890699|NCT03893448|141266962|NON_INFERIORITY|A conclusion of non-inferiority of HIBERIX™ administered concomitantly with V114 to HIBERIX™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|-1.1|||<|0.001|TWO_SIDED|95.0|-2.2|-0.5||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||-0.5|-2.2|< 0.001
70890700|NCT03893448|141266963|SUPERIORITY||GMC Ratio (V114 / Prevnar 13™)|92.03|||<|0.001|TWO_SIDED|95.0|83.47|101.47|||t-test, 1 sided||V114/Prevnar 13™|Serotype 22F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||101.47|83.47|< 0.001
70890701|NCT03893448|141266963|SUPERIORITY||GMC Ratio (V114 / Prevnar 13™)|29.5|||<|0.001|TWO_SIDED|95.0|26.16|33.26|||t-test, 1 sided||V114/Prevnar 13™|Serotype 33F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||33.26|26.16|< 0.001
70890702|NCT03893448|141266964|SUPERIORITY||Percentage Point Difference|95.1|||<|0.001|TWO_SIDED|95.0|93.1|96.5||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 22F Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||96.5|93.1|< 0.001
70890703|NCT03893448|141266964|SUPERIORITY||Percentage Point Difference|85.2|||<|0.001|TWO_SIDED|95.0|82.3|87.7||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 33F Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||87.7|82.3|< 0.001
70890704|NCT03893448|141266965|SUPERIORITY||GMC Ratio (V114 / Prevnar 13™)|68.8|||<|0.001|TWO_SIDED|95.0|63.1|75.02|||t-test, 1 sided||V114/Prevnar 13™|Serotype 22F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||75.02|63.10|< 0.001
70890705|NCT03893448|141266965|SUPERIORITY||GMC Ratio (V114 / Prevnar 13™)|44.91|||<|0.001|TWO_SIDED|95.0|41.04|49.14|||t-test, 1 sided||V114/Prevnar 13™|Serotype 33F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||49.14|41.04|< 0.001
70890706|NCT03893448|141266968|SUPERIORITY||Percentage Point Difference|15.6|||<|0.001|TWO_SIDED|95.0|12.1|19.2||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method||19.2|12.1|< 0.001
70890707|NCT03893448|141266969|SUPERIORITY||GMC Ratio (V114 / Prevnar 13™)|1.73|||<|0.001|TWO_SIDED|95.0|1.61|1.87|||t-test, 1 sided||V114/Prevnar 13™|GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.87|1.61|< 0.001
70890708|NCT03893448|141266970|SUPERIORITY||GMC Ratio (V114 / Prevnar 13™)|1.35|||<|0.001|TWO_SIDED|95.0|1.25|1.46|||t-test, 1 sided||V114/Prevnar 13™|GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.46|1.25|< 0.001
70890709|NCT05061446|141267000|OTHER||Difference in percentage|6.7|||||TWO_SIDED|95.0|-5.96|19.29||||||||19.29|-5.96|
70890710|NCT05061446|141267000|OTHER||Difference in percentage|26.3|||||TWO_SIDED|95.0|6.52|46.12||||||||46.12|6.52|
70890711|NCT05061446|141267001|OTHER||Difference in percentage|6.7|||||TWO_SIDED|95.0|-5.96|19.29||||||||19.29|-5.96|
70890712|NCT05061446|141267001|OTHER||Difference in percentage|26.3|||||TWO_SIDED|95.0|6.52|46.12||||||||46.12|6.52|
70890713|NCT05061446|141267002|OTHER||Difference in percentage|20.0|||||TWO_SIDED|95.0|-0.24|40.24||||||||40.24|-0.24|
70890714|NCT05061446|141267002|OTHER||Difference in percentage|31.6|||||TWO_SIDED|95.0|10.68|52.48||||||||52.48|10.68|
70890715|NCT05061446|141267003|OTHER||Difference in percentage|6.7|||||TWO_SIDED|95.0|-5.96|19.29||||||||19.29|-5.96|
70890716|NCT05061446|141267003|OTHER||Difference in percentage|5.3|||||TWO_SIDED|95.0|-4.78|15.3||||||||15.30|-4.78|
70890717|NCT05061446|141267004|OTHER||Difference in percentage|26.2|||||TWO_SIDED|95.0|-1.22|53.6||||||||53.60|-1.22|
70890718|NCT05061446|141267004|OTHER||Difference in percentage|45.5|||||TWO_SIDED|95.0|19.3|71.68||||||||71.68|19.30|
70890719|NCT03880578|141267007|SUPERIORITY||Mean Difference (Final Values)|-10.3|||<|0.001|TWO_SIDED|95.0|-14.9|-5.7|||Mixed Models Analysis|The outcome measure is change over time between treatment groups, reported as a mean adjusted difference.|change in the composite score of the ThyPRO between groups|||-5.7|-14.9|<0.001
70890720|NCT03880578|141267008|SUPERIORITY||Mean Difference (Final Values)|-2.14||||0.06|TWO_SIDED|95.0|-4.34|0.06|||Mixed Models Analysis|||||0.06|-4.34|0.06
70890721|NCT03880578|141267009|SUPERIORITY||Median Difference (Final Values)|1.7|||<|0.001|TWO_SIDED|95.0|1.27|2.03|||Mixed Models Analysis||MAD obtained after log transformation of TSH|||2.03|1.27|<0.001
70890722|NCT03880578|141267010|SUPERIORITY||Mean Difference (Final Values)|-0.61|||<|0.001|TWO_SIDED|95.0|-0.87|-0.35|||Mixed Models Analysis|||FT3||-0.35|-0.87|<0.001
70890723|NCT03880578|141267010|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.12|TWO_SIDED|95.0|-1.81|0.15|||Mixed Models Analysis|||FT4||0.15|-1.81|0.12
70890724|NCT03880578|141267011|SUPERIORITY||Mean Difference (Final Values)|-11.6|||<|0.001|TWO_SIDED|95.0|-14.6|-8.5|||Mixed Models Analysis|||||-8.5|-14.6|<0.001
70890725|NCT04177108|141267041|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.0098||95.0|0.28|0.85|||Log Rank|||||0.85|0.28|0.0098
70890726|NCT04177108|141267041|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.2396||95.0|0.42|1.25|||Log Rank|||||1.25|0.42|0.2396
70890727|NCT04177108|141267041|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9809||95.0|0.63|1.58|||Log Rank|||||1.58|0.63|0.9809
70890728|NCT04177108|141267042|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.6805||95.0|0.55|2.51|||Log Rank|||||2.51|0.55|0.6805
70890729|NCT04177108|141267042|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.6314||95.0|0.55|2.64|||Log Rank|||||2.64|0.55|0.6314
70890730|NCT04177108|141267042|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9164||95.0|0.52|2.06|||Log Rank|||||2.06|0.52|0.9164
70890731|NCT01827904|141267049|SUPERIORITY|Percent change from Baseline at the 3 Month visit in the Exablate test vs. Sham control arms was tested using the t-test.|||||<|0.001|||||||t-test, 1 sided|alpha = 0.05 for the hypothesis test. H0: M3ExAblate ≤ M3Sham H1: M3ExAblate \> M3Sham||"Note that the Crossover group was a rescue treatment group and not integral to the experimental design statistical analysis."||||<0.001
70890732|NCT01891734|141267060|SUPERIORITY_OR_OTHER||Cohen's d|0.3|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
70890733|NCT01891734|141267061|SUPERIORITY_OR_OTHER||Cohen's d|0.3|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
70890734|NCT01181895|141267063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.244|TWO_SIDED|95.0|-0.048|0.188||P-value for the adjusted treatment difference for Vilanterol 25 µg OD versus Placebo.|ANCOVA||The estimated value represents the adjusted treatment difference in the weighted mean 0-24 hour FEV1 (Liters) at Week 12 for Vilanterol 25 µg OD versus Placebo.|||0.188|-0.048|0.244
70890735|NCT01181895|141267063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006||||0.926|TWO_SIDED|95.0|-0.124|0.113||P-value for the adjusted treatment difference for Salmetarol 50 µg BID versus Placebo.|ANCOVA||The estimated value represents the adjusted treatment difference in the weighted mean 0-24 hour FEV1 (Liters) at Week 12 for Salmeterol 50 µg BID versus Placebo.|||0.113|-0.124|0.926
70890736|NCT01312467|141267096|SUPERIORITY_OR_OTHER||||||>|0.773|TWO_SIDED||||||A paired t-test|||||||> 0.773
70890737|NCT02752048|141267108|OTHER|Change in time to rise from the floor from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|-1.378||||0.596|TWO_SIDED|95.0|-6.757|4.0|||t-test, 2 sided|||||4.000|-6.757|0.596
70890738|NCT02752048|141267108|OTHER|Change in time to rise from the floor from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|1.349||||0.433|TWO_SIDED|95.0|-2.22|4.918|||t-test, 2 sided|||||4.918|-2.220|0.433
70890739|NCT02752048|141267109|OTHER|Change in 10-m walk/run test from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|-0.484||||0.382|TWO_SIDED|95.0|-1.618|0.65|||t-test, 2 sided|||||0.650|-1.618|0.382
70890740|NCT02752048|141267109|OTHER|Change in 10-m walk/run test from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|-0.397||||0.501|TWO_SIDED|95.0|-1.61|0.817|||t-test, 2 sided|||||0.817|-1.610|0.501
70890741|NCT02752048|141267110|OTHER|Change in time to up and go from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|-0.533||||0.549|TWO_SIDED|95.0|-2.363|1.298|||t-test, 2 sided|||||1.298|-2.363|0.549
70890742|NCT02752048|141267110|OTHER|Change in time to up and go from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|-0.225||||0.767|TWO_SIDED|95.0|-1.801|1.351|||t-test, 2 sided|||||1.351|-1.801|0.767
70890743|NCT00019682|141267122|SUPERIORITY|||||||0.035|||||||Chi-squared|||||||0.035
70890744|NCT00019682|141267123|SUPERIORITY|||||||0.008||||||Unadjusted 2 tail p value.|Log Rank|||||||0.008
70890745|NCT00019682|141267124|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
70890746|NCT00019682|141267125|NON_INFERIORITY|Evaluated inferiority in quality of life outcomes between arms.|||||>|0.05|||||||Mixed Models Analysis|||FACT-G scale||||>0.05
70890747|NCT00019682|141267125|NON_INFERIORITY|Evaluated inferiority in quality of life outcomes between arms.|||||>|0.05|||||||Mixed Models Analysis|||FACT-F scale||||>0.05
70890748|NCT00019682|141267125|NON_INFERIORITY|Evaluated inferiority in quality of life outcomes between arms.|||||>|0.05|||||||Mixed Models Analysis|||SF-36 scale||||>0.05
70890749|NCT00019682|141267125|NON_INFERIORITY|Evaluated inferiority in quality of life outcomes between arms.|||||>|0.05|||||||Mixed Models Analysis|||SDS scale||||>0.05
70890750|NCT05932290|141267128|SUPERIORITY||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.37|0.71|||Regression, Cox||Hazard ratios (HRs) were estimated using unadjusted Cox proportional hazard models.|||0.71|0.37|<.0001
70890751|NCT05932290|141267129|SUPERIORITY||Hazard Ratio (HR)|0.37||||0.0003|TWO_SIDED|95.0|0.22|0.64|||Regression, Cox||IPTW HRs were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances.|||0.64|0.22|.0003
70890752|NCT05932290|141267132|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0062|TWO_SIDED|95.0|0.47|0.88|||Regression, Cox||HRs were estimated using unadjusted Cox proportional hazard models.|||0.88|0.47|.0062
70890753|NCT05932290|141267133|SUPERIORITY||Hazard Ratio (HR)|0.46||||0.0032|TWO_SIDED|95.0|0.27|0.77|||Regression, Cox|IPTW HRs were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances.||||0.77|0.27|.0032
70890754|NCT03223298|141267159|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||3-month mean change (from pre-op) in Jaw Pain compared between the Botox group and Placebo group.||||0.80
70890755|NCT03223298|141267160|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||3-month mean Jaw Function Limitation Scale score compared between Botox group and placebo group.||||0.50
70890756|NCT03223298|141267161|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Change in MIO with Pain at 3-months post-intervention compared between Botox group and Placebo group.||||0.30
70890757|NCT03223298|141267161|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Change in MIO without Pain at 3-months post-intervention compared between Botox group and Placebo group.||||0.50
70890758|NCT03223298|141267162|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Mean change at 3 months post intervention - General Health Score, compared between Botox group and Placebo group.||||0.40
70890759|NCT01782131|141267163|NON_INFERIORITY|Based on Miettinen and Nurminen's method stratified by the risk for mortality/poor outcome (high risk, not high risk) and using Cochran-Mantel-Haenszel weighting scheme. The p-Value is based on the one-sided non-inferiority test. Non-inferiority of posaconazole vs. voriconazole is established if the upper limit of the 95% confidence interval is less than 10%.|Estimated Difference in Percent|-5.3|||<|0.0001|TWO_SIDED|95.0|-11.6|1.0|||Miettinen and Nurminen|||||1.0|-11.6|<.0001
70890760|NCT01782131|141267164|OTHER|Based on Miettinen and Nurminen's method stratified by the risk for mortality/poor outcome (high risk, not high risk) and using Cochran-Mantel-Haenszel weighting scheme.|Estimated Difference in Percent|0.3|||||TWO_SIDED|95.0|-8.2|8.8||||||||8.8|-8.2|
70890761|NCT01782131|141267165|OTHER|Based on Miettinen and Nurminen's method stratified by the risk for mortality/poor outcome (high risk, not high risk) and using Cochran-Mantel-Haenszel weighting scheme.|Estimated Difference in Percent|-2.5|||||TWO_SIDED|95.0|-9.9|4.9||||||||4.9|-9.9|
70890762|NCT01782131|141267166|OTHER|Based on Miettinen and Nurminen's method stratified by the risk for mortality/poor outcome (high risk, not high risk) and using Cochran-Mantel-Haenszel weighting scheme.|Estimated Difference in Percent|3.1|||||TWO_SIDED|95.0|-6.9|13.1||||||||13.1|-6.9|
70890763|NCT01782131|141267167|OTHER|Based on Miettinen and Nurminen's method stratified by the risk for mortality/poor outcome (high risk, not high risk) and using Cochran-Mantel-Haenszel weighting scheme.|Estimated Difference in Percent|-3.4|||||TWO_SIDED|95.0|-13.9|7.1||||||||7.1|-13.9|
70890764|NCT01782131|141267168|OTHER|Based on Miettinen and Nurminen's method stratified by the risk for mortality/poor outcome (high risk, not high risk) and using Cochran-Mantel-Haenszel weighting scheme.|Difference in Percent|-0.6|||||TWO_SIDED|95.0|-11.2|10.1||||||||10.1|-11.2|
70890765|NCT01782131|141267169|OTHER||Survival Rate in Percent|60.7||||0.2767|TWO_SIDED|95.0|52.8|67.8||Based on Stratified Log-Rank method stratified by the risk for mortality/poor outcome (high risk, not high risk).|Kaplan-Meier|From product-limit (Kaplan-Meier) method for censored data.||Analysis of Time to All-Cause Mortality Through Day 114: Posaconazole vs. Voriconazole||67.8|52.8|0.2767
70890766|NCT01782131|141267170|OTHER|Based on Miettinen and Nurminen's method.|Difference in Percent|20.4|||||TWO_SIDED|95.0|-4.1|42.7||||||||42.7|-4.1|
70890767|NCT01782131|141267171|OTHER|Based on Miettinen and Nurminen's method.|Difference in Percent|11.3|||||TWO_SIDED|95.0|-6.9|28.6||||||||28.6|-6.9|
70890768|NCT01782131|141267172|OTHER||Difference in Percent|0.3||||0.8305|TWO_SIDED|95.0|-2.9|3.6|||Miettinen & Nurminen|||Abnormal Hepatic Laboratory Value||3.6|-2.9|0.8305
70890769|NCT01782131|141267172|OTHER||Difference in Percent|-3.6||||0.3633|TWO_SIDED|95.0|-11.3|4.2|||Miettinen & Nurminen|||CNS and Visual Disturbances||4.2|-11.3|0.3633
70890770|NCT01782131|141267172|OTHER||Difference in Percent|-2.8||||0.3724|TWO_SIDED|95.0|-9.1|3.4|||Miettinen & Nurminen|||Dermatologic Reactions||3.4|-9.1|0.3724
70890771|NCT01782131|141267172|OTHER||Difference in Percent|1.0||||0.6431|TWO_SIDED|95.0|-3.4|5.5|||Miettinen & Nurminen|||Adrenal Insufficiency or Temporal Hypotension||5.5|-3.4|0.6431
70890772|NCT01782131|141267173|OTHER|Based on Miettinen \& Nurminen|Difference in Percent|0.0|||||TWO_SIDED|95.0|-2.8|2.8||||||||2.8|-2.8|
70890773|NCT01782131|141267174|OTHER|Based on Miettinen \& Nurminen method.|Difference in Percent|-10.2|||||TWO_SIDED|95.0|-17.9|-2.4||||||||-2.4|-17.9|
70890774|NCT01782131|141267175|OTHER|Based on Miettinen \& Nurminen method.|Difference in Percent|1.9|||||TWO_SIDED|95.0|-6.1|9.8||||||||9.8|-6.1|
70890775|NCT01782131|141267176|OTHER|Based on Miettinen \& Nurminen method.|Difference in Percent|-1.4|||||TWO_SIDED|95.0|-5.6|2.7||||||||2.7|-5.6|
70890776|NCT01782131|141267177|OTHER|Based on Miettinen \& Nurminen method.|Difference in Percent|-3.2|||||TWO_SIDED|95.0|-11.0|4.5||||||||4.5|-11.0|
70890777|NCT01627249|141267179|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.5|||<|0.001|TWO_SIDED|95.0|1.4|5.7|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs. Bevacizumab||5.7|1.4|<0.001
70890778|NCT01627249|141267179|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.1||||0.034|TWO_SIDED|95.0|0.1|4.2|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs. Ranibizumab||4.2|0.1|0.034
70890779|NCT01627249|141267179|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4||||0.12|TWO_SIDED|95.0|-0.4|3.2|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Ranibizumab vs. Bevacizumab||3.2|-0.4|0.12
70890780|NCT01627249|141267180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-69.9|||<|0.001|TWO_SIDED|95.0|-91.1|-48.6|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs Bevacizumab||-48.6|-91.1|<0.001
70890781|NCT01627249|141267180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.6||||0.036|TWO_SIDED|95.0|-36.0|-1.2|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs Ranibizumab||-1.2|-36|0.036
70890782|NCT01627249|141267180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-51.2|||<|0.001|TWO_SIDED|95.0|-71.2|-31.3|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Ranibizumab vs Bevacizumab||-31.3|-71.2|<0.001
70890783|NCT01627249|141267181|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.5||||0.001|TWO_SIDED|95.0|2.9|10.1|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs. Bevacizumab||10.1|2.9|0.001
70890784|NCT01627249|141267181|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.7||||0.0031|TWO_SIDED|95.0|1.4|8.0|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs. Ranibizumab||8.0|1.4|0.0031
70890785|NCT01627249|141267181|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.8||||0.21|TWO_SIDED|95.0|-1.1|4.8|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Ranibizumab vs Bevacizumab||4.8|-1.1|0.21
70890786|NCT01627249|141267182|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7||||0.69|TWO_SIDED|95.0|-1.3|2.7|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs Bevacizumab||2.7|-1.3|0.69
70890787|NCT01627249|141267182|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.69|TWO_SIDED|95.0|-2.3|1.5|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs Ranibizumab||1.5|-2.3|0.69
70890788|NCT01627249|141267182|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1||||0.69|TWO_SIDED|95.0|-0.9|3.1|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Ranibizumab vs Bevacizumab||3.1|-0.9|0.69
70890789|NCT01073618|141267225|SUPERIORITY_OR_OTHER||Efficacy rate (percent)|75.15|||||TWO_SIDED|95.0|71.36|78.94|||Normal approximation to binomial||Confidence Interval (CI) by normal approximation to binomial.|Efficacy Rate (treatment effective) = Percentage of evaluable participants with clinical response of cure or improvement||78.94|71.36|
70890790|NCT00982020|141267253|SUPERIORITY_OR_OTHER|||||||0.15||||||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed model repeated measures analysis terms included baseline BMI, baseline age, gender, intervention group, visit, region, intervention group\*visit.||||||0.150
70890791|NCT00982020|141267254|SUPERIORITY_OR_OTHER|||||||0.52||||||The threshold for statistical significance was 0.05.|ANCOVA|ANCOVA model terms included: baseline, baseline age, gender, intervention group, and region.||||||0.520
70890792|NCT00982020|141267256|SUPERIORITY_OR_OTHER|||||||0.008||||||Threshold for statistical significance was 0.05|Mixed Models Analysis|MMRM analysis terms included baseline, intervention group, visit, region, and intervention group\*visit.||||||0.008
70890793|NCT00982020|141267257|SUPERIORITY_OR_OTHER|||||||0.266||||||The threshold for statistical significance was 0.05|Mixed Models Analysis|MMRM analysis terms included intervention group, visit, region, and intervention group\*visit.||||||0.266
70890794|NCT00982020|141267258|SUPERIORITY_OR_OTHER|||||||0.954||||||The threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM analysis terms included baseline, baseline age, gender, intervention group, visit, region, and intervention group\*visit.||||||0.954
70890795|NCT00982020|141267259|SUPERIORITY_OR_OTHER|||||||0.103||||||Threshold for statistical significance was 0.05|Mixed Models Analysis|MMRM analysis terms included baseline, intervention group, visit, region, and intervention group\*visit.||||||0.103
70890796|NCT00982020|141267260|SUPERIORITY_OR_OTHER|||||||0.436||||||The threshold for statistical significance was 0.05|Mixed Models Analysis|MMRM analysis terms included baseline, intervention group, visit, region, and intervention group\*visit.||||||0.436
70890797|NCT01722331|141267261|SUPERIORITY||Difference in percentages|56.6|||<|0.001|TWO_SIDED|95.0|49.6|62.8|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||62.8|49.6|<0.001
70890798|NCT01722331|141267261|SUPERIORITY||Difference in percentages|58.0|||<|0.001|TWO_SIDED|95.0|51.0|64.1|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||64.1|51.0|<0.001
70890799|NCT01722331|141267262|SUPERIORITY||Difference in percentages|52.1|||<|0.001|TWO_SIDED|95.0|44.8|58.5|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||58.5|44.8|<0.001
70890800|NCT01722331|141267262|SUPERIORITY||Difference in percentages|50.9|||<|0.001|TWO_SIDED|95.0|43.6|57.4|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||57.4|43.6|<0.001
70890801|NCT01722331|141267266|SUPERIORITY||Difference in percentages|32.9|||<|0.001|TWO_SIDED|95.0|26.8|38.8|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||38.8|26.8|<0.001
70890802|NCT01722331|141267266|SUPERIORITY||Difference in percentages|32.1|||<|0.001|TWO_SIDED|95.0|25.9|38.0|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||38.0|25.9|<0.001
70890803|NCT01722331|141267267|SUPERIORITY||Difference in percentages|12.7|||<|0.001|TWO_SIDED|95.0|8.3|17.2|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||17.2|8.3|<0.001
70890804|NCT01722331|141267267|SUPERIORITY||Difference in percentages|12.7|||<|0.001|TWO_SIDED|95.0|8.0|17.3|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||17.3|8.0|<0.001
70890805|NCT01722331|141267269|OTHER||Difference in least squares means|-7.7|||<|0.001|TWO_SIDED|95.0|-8.6|-6.8|||Constrained Longitudinal Data Analysis|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-6.8|-8.6|<0.001
70890806|NCT01722331|141267269|OTHER||Difference in least squares means|-7.4|||<|0.001|TWO_SIDED|95.0|-8.3|-6.5|||Constrained Longitudinal Data Analysis|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-6.5|-8.3|<0.001
70890807|NCT01722331|141267270|OTHER||Difference in percentages|38.9|||<|0.001|TWO_SIDED|95.0|31.9|45.4|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||45.4|31.9|<0.001
70890808|NCT01722331|141267270|OTHER||Difference in percentages|36.1|||<|0.001|TWO_SIDED|95.0|29.3|42.5|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||42.5|29.3|<0.001
70890809|NCT00262834|141267272|SUPERIORITY_OR_OTHER_LEGACY|||||||0.42||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum tests were used to compare the differences (post-pre) between groups.||||||0.42
70890810|NCT00262834|141267273|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum tests were used to compare the differences (post-pre) between groups.||||||0.50
70890811|NCT00262834|141267274|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
70890812|NCT04564833|141267278|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70890813|NCT04564833|141267278|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70890814|NCT04564833|141267279|SUPERIORITY|||||||0.3954|||||||ANCOVA|||||||0.3954
70890815|NCT04564833|141267279|SUPERIORITY|||||||0.0682|||||||ANCOVA|||||||0.0682
70890816|NCT04564833|141267280|SUPERIORITY|||||||0.6755|||||||Fisher Exact|||||||0.6755
70890817|NCT04564833|141267280|SUPERIORITY|||||||0.6758|||||||Fisher Exact|||||||0.6758
70890818|NCT04564833|141267281|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||||||>0.9999
70890819|NCT04564833|141267281|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||||||>0.9999
70890820|NCT01075074|141267332|SUPERIORITY_OR_OTHER|||||||0.006||||||Corrected for 6 comparisons.|Kruskal-Wallis|||A sample size of 23 subjects per group was estimated to achieve 80% power to detect a 10 point difference in the aggregated QOR40 score for the 3 study groups to be compared assuming an overall standard deviation of 12.||||0.006
70890821|NCT01075074|141267332|SUPERIORITY_OR_OTHER||Median Difference (Net)|16.0||||0.03|TWO_SIDED|95.0|1.0|30.0|||Wilcoxon (Mann-Whitney)|||||30|1|0.03
70890822|NCT01075074|141267332|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.0||||0.01|TWO_SIDED|95.0|2.0|31.0|||Wilcoxon (Mann-Whitney)|||||31|2|0.01
70890823|NCT01075074|141267332|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0||||1|TWO_SIDED|95.0|-16.0|12.0|||Wilcoxon (Mann-Whitney)|||||12|-16|1.0
70890824|NCT01075074|141267333|SUPERIORITY_OR_OTHER|||||||0.0003||95.0||||P values is corrected for 6 comparisons|Kruskal-Wallis|||||||0.0003
70890825|NCT01075074|141267333|SUPERIORITY_OR_OTHER|||||||0.0003||95.0||||Corrected for 6 comparisons|Kruskal-Wallis|||||||0.0003
70890826|NCT01075074|141267333|SUPERIORITY_OR_OTHER||Median Difference (Net)|195.0||||0.0004|TWO_SIDED|95.0|98.0|300.0|||Wilcoxon (Mann-Whitney)|||||300|98|0.0004
70890827|NCT01075074|141267333|SUPERIORITY_OR_OTHER||Median Difference (Net)|195.0||||0.0003|TWO_SIDED|95.0|98.0|278.0|||Wilcoxon (Mann-Whitney)|||||278|98|0.0003
70890828|NCT01075074|141267333|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.86|TWO_SIDED|95.0|-105.0|83.0|||Wilcoxon (Mann-Whitney)|||||83|-105|0.86
70890829|NCT01075074|141267334|SUPERIORITY_OR_OTHER|||||||0.0005||95.0||||Corrected for multiple comparisons (n=6).|Kruskal-Wallis|||||||0.0005
70890830|NCT01075074|141267334|SUPERIORITY_OR_OTHER||Median Difference (Net)|38.0||||0.01|TWO_SIDED|95.0|8.0|50.0|||Wilcoxon (Mann-Whitney)|||||50|8|0.01
70890831|NCT01075074|141267334|SUPERIORITY_OR_OTHER||Median Difference (Net)|40.0||||0.003|TWO_SIDED|95.0|12.0|47.0|||Wilcoxon (Mann-Whitney)|||||47|12|0.003
70890832|NCT01075074|141267334|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0||||0.95|TWO_SIDED|95.0|-18.0|20.0|||Wilcoxon (Mann-Whitney)|||||20|-18|0.95
70890833|NCT01075074|141267335|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Corrected for multiple comparisons (n=6).|Kruskal-Wallis|||||||0.03
70890834|NCT01075074|141267335|SUPERIORITY_OR_OTHER||Median Difference (Net)|30.0||||0.01|TWO_SIDED|95.0|0.0|60.0|||Wilcoxon (Mann-Whitney)|||||60|0|0.01
70890835|NCT01075074|141267335|SUPERIORITY_OR_OTHER||Median Difference (Net)|30.0||||0.04|TWO_SIDED|95.0|0.0|60.0|||Wilcoxon (Mann-Whitney)|||||60|0|0.04
70890836|NCT01075074|141267335|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.92|TWO_SIDED|95.0|-30.0|30.0|||Wilcoxon (Mann-Whitney)|||||30|-30|0.92
70890837|NCT04265755|141267336|OTHER|Adjusted analysis utilizes a logistic regression model which includes age, sex, dose switch, Baseline value of interest, and mPRS as covariates and presents the mPRS estimates.|Odds Ratio (OR)|1.01||||0.86|TWO_SIDED|95.0|0.9|1.13|||Regression, Logistic||Based on a 1 standard deviation increase in mPRS.|Odds of achieving at least 50% reduction from Baseline in mean MMD over months 4, 5, and 6 in relation to mPRS.||1.13|0.90|0.86
70890838|NCT00618657|141267359|OTHER||Standard Error|0.03|||||TWO_SIDED|||||||||||||
70890839|NCT00618657|141267359|OTHER||Standard Error|0.03|||||TWO_SIDED|||||||||||||
70890840|NCT01762761|141267363|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|26.08|||<|0.001|TWO_SIDED|95.0|7.29|93.26|||Regression, Logistic|||||93.26|7.29|<0.001
70890841|NCT01762761|141267364|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|23.8|||<|0.001|TWO_SIDED|95.0|8.54|66.33|||Regression, Logistic|||||66.33|8.54|<0.001
70890842|NCT01762761|141267365|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.52|||<|0.001|TWO_SIDED|95.0|3.84|18.94|||Regression, Logistic|||||18.94|3.84|<0.001
70890843|NCT01762761|141267366|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.28||||0.001|TWO_SIDED|95.0|0.13|0.59|||Mixed Models Analysis|||||0.59|0.13|0.001
70890844|NCT01762761|141267367|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.59||||0.306|TWO_SIDED|95.0|0.21|1.64|||Mixed Models Analysis|||||1.64|0.21|0.306
70890845|NCT01762761|141267368|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|6.12|||<|0.001|TWO_SIDED|95.0|4.01|9.34|||Log Rank|||||9.34|4.01|<0.001
70890846|NCT01762761|141267369|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.13|||<|0.001|TWO_SIDED|95.0|0.05|0.37|||Regression, Logistic|||||0.37|0.05|<0.001
70890847|NCT01762761|141267370|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|16.54||||0.008|TWO_SIDED|95.0|2.09|131.12|||Regression, Logistic|||||131.12|2.09|0.008
70890848|NCT01762761|141267371|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||van Elteren stratified rank test|||||||<0.001
70890849|NCT01762761|141267372|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||van Elteren stratified rank test|||||||<0.001
70890850|NCT00795600|141267397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.645|STANDARD_ERROR_OF_MEAN|3.364||0.849||95.0|-7.404|6.114||H01 (hypothesis): Micro detemir = micro NPH against the alternative H01: Microl detemir ≠ micro NPH.|ANCOVA|||The primary objective and endpoint of the trial was to compare the change in trunk fat mass (g) between insulin detemir versus insulin NPH at baseline and at week 26. A standard deviation of 5% was chosen based on a previous trial. A difference in trunk fat mass of 5% was considered clinically relevant also according to this trial.||6.114|-7.404|0.849
70890851|NCT00795600|141267398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|3.478||0.948||95.0|-7.588|6.407||H01: Micro detemir = micro NPH against the alternative H01: Microl detemir ≠ micro NPH.|ANCOVA|||The primary objective and endpoint of the trial was to compare the change in trunk fat mass (g) between insulin detemir versus insulin NPH at baseline and at week 26. A standard deviation of 5% was chosen based on a previous trial. A difference in trunk fat mass of 5% was considered clinically relevant also according to this trial.||6.407|-7.588|0.948
70890852|NCT00795600|141267399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|196.36|STANDARD_ERROR_OF_MEAN|498.7||0.696||95.0|-805.8|1198.5||H01: Micro detemir = micro NPH against the alternative H01: Microl detemir ≠ micro NPH.|ANCOVA|||The primary objective and endpoint of the trial was to compare the change in trunk fat mass (g) between insulin detemir versus insulin NPH at baseline and at week 26. A standard deviation of 5% was chosen based on a previous trial. A difference in trunk fat mass of 5% was considered clinically relevant also according to this trial.||1198.5|-805.8|0.696
70890853|NCT00795600|141267400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|192.81|STANDARD_ERROR_OF_MEAN|515.4||0.71||95.0|-844.0|1229.7||H01: Micro detemir = micro NPH against the alternative H01: Microl detemir ≠ micro NPH.|ANCOVA|||The primary objective and endpoint of the trial was to compare the change in trunk fat mass (g) between insulin detemir versus insulin NPH at baseline and at week 26. A standard deviation of 5% was chosen based on a previous trial. A difference in trunk fat mass of 5% was considered clinically relevant also according to this trial.||1229.7|-844.0|0.710
70890854|NCT00795600|141267401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|288.21|STANDARD_ERROR_OF_MEAN|766.41||0.709||95.0|-1252.0|1828.4|||ANCOVA|||||1828.4|-1252.0|0.709
70890855|NCT00795600|141267402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.178|STANDARD_ERROR_OF_MEAN|2.732||0.948||95.0|-5.668|5.313|||ANCOVA|||||5.313|-5.668|0.948
70890856|NCT00795600|141267403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1151.0|STANDARD_ERROR_OF_MEAN|810.48||0.162||95.0|-2780.0|477.33|||ANCOVA|||||477.33|-2780.0|0.162
70890857|NCT00795600|141267404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.747|STANDARD_ERROR_OF_MEAN|1.788||0.131||95.0|-6.34|0.846|||ANCOVA|||||0.846|-6.340|0.131
70890858|NCT00795600|141267405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-110.4|STANDARD_ERROR_OF_MEAN|368.69||0.766||95.0|-851.3|630.51|||ANCOVA|||||630.51|-851.3|0.766
70890859|NCT00795600|141267406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|1.662||0.716||95.0|-3.949|2.729|||ANCOVA|||||2.729|-3.949|0.716
70890860|NCT00795600|141267407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.491|STANDARD_ERROR_OF_MEAN|0.695||0.483||95.0|-0.906|1.888|||ANCOVA|||||1.888|-0.906|0.483
70890861|NCT00795600|141267408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.116|STANDARD_ERROR_OF_MEAN|1.909||0.952||95.0|-3.721|3.953|||ANCOVA|||||3.953|-3.721|0.952
70890862|NCT00795600|141267409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.278|STANDARD_ERROR_OF_MEAN|0.746||0.711||95.0|-1.778|1.221|||ANCOVA|||||1.221|-1.778|0.711
70890863|NCT00795600|141267410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.585|STANDARD_ERROR_OF_MEAN|1.854||0.397||95.0|-5.31|2.141|||ANCOVA|||||2.141|-5.310|0.397
70890864|NCT00795600|141267411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.916|STANDARD_ERROR_OF_MEAN|10.985||0.421||95.0|-30.99|13.159|||ANCOVA|||||13.159|-30.99|0.421
70890865|NCT00795600|141267412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.061|STANDARD_ERROR_OF_MEAN|6.216||0.42||95.0|-17.55|7.43|||ANCOVA|||||7.430|-17.55|0.420
70890866|NCT00795600|141267413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.961|STANDARD_ERROR_OF_MEAN|13.007||0.705||95.0|-31.1|21.178|||ANCOVA|||||21.178|-31.10|0.705
70890867|NCT00795600|141267414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.59|STANDARD_ERROR_OF_MEAN|4.776||0.341||95.0|-14.19|5.007|||ANCOVA|||||5.007|-14.19|0.341
70890868|NCT00795600|141267415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.034||0.902||95.0|-0.064|0.073|||ANCOVA|||||0.073|-0.064|0.902
70890869|NCT00795600|141267416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.789|STANDARD_ERROR_OF_MEAN|3.85||0.839||95.0|-8.525|6.947|||ANCOVA|||||6.947|-8.525|0.839
70890870|NCT00795600|141267417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.041||0.607||95.0|-0.105|0.062|||ANCOVA|||||0.062|-0.105|0.607
70890871|NCT00795600|141267418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.777|STANDARD_ERROR_OF_MEAN|3.719||0.635||95.0|-9.254|5.7|||ANCOVA|||||5.700|-9.254|0.635
70890872|NCT00795600|141267419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.266||0.628||95.0|-0.663|0.403|||ANCOVA|||||0.403|-0.663|0.628
70890873|NCT00795600|141267420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.92|STANDARD_ERROR_OF_MEAN|17.46||0.535||95.0|-46.03|24.182|||ANCOVA|||||24.182|-46.03|0.535
70890874|NCT00795600|141267421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.918|STANDARD_ERROR_OF_MEAN|4.332||0.66||95.0|-10.65|6.813|||ANCOVA|||||6.813|-10.65|0.660
70890875|NCT00795600|141267448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.629|STANDARD_ERROR_OF_MEAN|0.967||0.518||95.0|-2.572|1.313|||ANCOVA|||||1.313|-2.572|0.518
70890876|NCT00795600|141267449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.546|STANDARD_ERROR_OF_MEAN|1.283||0.673||95.0|-3.123|2.032|||ANCOVA|||||2.032|-3.123|0.673
70890877|NCT00795600|141267450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.466|STANDARD_ERROR_OF_MEAN|1.386||0.738||95.0|-2.319|3.25|||ANCOVA|||||3.250|-2.319|0.738
70890878|NCT00795600|141267451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.062|STANDARD_ERROR_OF_MEAN|2.168||0.346||95.0|-2.3|6.423|||ANCOVA|||||6.423|-2.300|0.346
70890879|NCT00795600|141267452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.726|STANDARD_ERROR_OF_MEAN|6.173||0.781||95.0|-10.71|14.167|||ANCOVA|||||14.167|-10.71|0.781
70890880|NCT02753751|141267492|SUPERIORITY|The Mantel-Haenszel test was used, accounting for each hospital as an individual stratum, and to obtain the pooled relative risks across hospitals without adjusting for other baseline factors. (Alert arm is the numerator, control arm is the denominator.) Patients discharged prior to 14 days without an outcome of interest were assumed to be free of that outcome at 14 days. A p-value of \<=0.04 was considered statistically significant to account for the interim analysis.|Risk Ratio (RR)|1.02||||0.67|TWO_SIDED|95.0|0.93|1.13||A p-value of \<=0.04 was considered statistically significant to account for the interim analysis.|Cochran-Mantel-Haenszel|||In our retrospective analysis of patients with AKI at 3 potential study hospitals, the composite outcome was 24.5%. A clinically meaningful relative reduction in this risk would be 20%. 5,024 patients (2,512 in each group) would have 90% power to detect a difference in outcome at least this extreme at a two-sided alpha of 0.05 as calculated using the Cochran-Mantel-Haenszel test. We have elected to increase this number by 20% to account for potential contamination.||1.13|0.93|0.67
70890881|NCT02334800|141267520|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|73.6|||||TWO_SIDED|90.0|57.81|93.71||||||||93.71|57.81|
70890882|NCT02334800|141267520|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|115.3|||||TWO_SIDED|90.0|90.57|146.79||||||||146.79|90.57|
70890883|NCT02334800|141267520|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|133.68|||||TWO_SIDED|90.0|105.0|170.19||||||||170.19|105.00|
70890884|NCT02334800|141267521|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|94.99|||||TWO_SIDED|90.0|69.93|129.03||||||||129.03|69.93|
70890885|NCT02334800|141267521|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|117.75|||||TWO_SIDED|90.0|86.69|159.95||||||||159.95|86.69|
70890886|NCT02334800|141267521|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|129.89|||||TWO_SIDED|90.0|95.63|176.43||||||||176.43|95.63|
70890887|NCT02334800|141267522|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|83.01|||||TWO_SIDED|90.0|65.37|105.43||||||||105.43|65.37|
70890888|NCT02334800|141267522|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|134.28|||||TWO_SIDED|90.0|105.73|170.53||||||||170.53|105.73|
70890889|NCT02334800|141267522|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|176.88|||||TWO_SIDED|90.0|139.28|224.63||||||||224.63|139.28|
70890890|NCT02334800|141267523|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|72.81|||||TWO_SIDED|90.0|56.43|93.93||||||||93.93|56.43|
70890891|NCT02334800|141267523|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|115.57|||||TWO_SIDED|90.0|89.58|149.11||||||||149.11|89.58|
70890892|NCT02334800|141267523|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|134.66|||||TWO_SIDED|90.0|104.38|173.73||||||||173.73|104.38|
70890893|NCT02334800|141267524|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|82.14|||||TWO_SIDED|90.0|63.83|105.71||||||||105.71|63.83|
70890894|NCT02334800|141267524|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|134.9|||||TWO_SIDED|90.0|104.82|173.6||||||||173.60|104.82|
70890895|NCT02334800|141267524|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|178.39|||||TWO_SIDED|90.0|138.62|229.57||||||||229.57|138.62|
70890896|NCT02334800|141267527|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|107.37|||||TWO_SIDED|90.0|78.06|147.68||||||||147.68|78.06|
70890897|NCT02334800|141267527|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|137.5|||||TWO_SIDED|90.0|99.96|189.12||||||||189.12|99.96|
70890898|NCT02334800|141267527|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|172.27|||||TWO_SIDED|90.0|125.25|236.96||||||||236.96|125.25|
70890899|NCT00801684|141267546|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||The difference between the active treatment was compared to placebo. For a null hypothesis, the difference would equal 0 (zero).||||<0.0001
70890900|NCT04079933|141267557|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline in urinary total NNAL|Mean Difference (Net)|-12.6||||0.2347|TWO_SIDED|95.0|-33.5|8.27|||t-test, 2 sided||"Difference in Least Square (LS) means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Percent Change from baseline = study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline in urinary total NNAL||8.27|-33.5|0.2347
70890901|NCT04079933|141267557|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline in urinary total NNAL|Mean Difference (Net)|-11.9||||0.2905|TWO_SIDED|95.0|-33.9|10.2|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~%Change from baseline = study group +visit +study group\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline in urinary total NNAL||10.2|-33.9|0.2905
70890902|NCT04079933|141267558|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study in urinary total NNAL|Mean Difference (Net)|-3.72||||0.9433|TWO_SIDED|95.0|-107.0|99.4|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Change from baseline = study group + visit + study group\*visit + subject +random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study in urinary total NNAL||99.4|-107|0.9433
70890903|NCT04079933|141267558|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in urinary total NNAL|Mean Difference (Net)|-12.2||||0.8264|TWO_SIDED|95.0|-122.0|97.5|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in urinary total NNAL||97.5|-122|0.8264
70890904|NCT04079933|141267559|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in nicotine equivalents|Mean Difference (Net)|-1.13||||0.4903|TWO_SIDED|95.0|-4.35|2.1|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Change from baseline = study group + visit + study group\*visit + subject +random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in nicotine equivalents||2.10|-4.35|0.4903
70890905|NCT04079933|141267559|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in nicotine equivalents|Mean Difference (Net)|-1.4||||0.4251|TWO_SIDED|95.0|-4.88|2.07|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in nicotine equivalents||2.07|-4.88|0.4251
70890906|NCT04079933|141267560|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in nicotine equivalents|Mean Difference (Net)|-9.83||||0.406|TWO_SIDED|95.0|-33.2|13.5|||t-test, 2 sided||"Difference in Least Square means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Percent Change from baseline = study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in nicotine equivalents||13.5|-33.2|0.4060
70890907|NCT04079933|141267560|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in nicotine equivalents|Mean Difference (Net)|-10.3||||0.4165|TWO_SIDED|95.0|-35.4|14.7|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~%Change from baseline = study group +visit +study group\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in nicotine equivalents||14.7|-35.4|0.4165
70890908|NCT04079933|141267561|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in S-PMA|Mean Difference (Net)|-269.0||||0.724|TWO_SIDED|95.0|-1773.0|1235.0|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Change from baseline = study group + visit + study group\*visit + subject +random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in S-PMA||1235|-1773|0.7240
70890909|NCT04079933|141267561|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in S-PMA|Mean Difference (Net)|50.5||||0.9508|TWO_SIDED|95.0|-1566.0|1667.0|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in S-PMA||1667|-1566|0.9508
70890910|NCT04079933|141267562|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in S-PMA|Mean Difference (Net)|-19.0||||0.1524|TWO_SIDED|95.0|-45.1|7.12|||t-test, 2 sided||"Difference in Least Square means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Percent Change from baseline = study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in S-PMA||7.12|-45.1|0.1524
70890911|NCT04079933|141267562|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in S-PMA|Mean Difference (Net)|-12.1||||0.4014|TWO_SIDED|95.0|-40.4|16.3|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~%Change from baseline = study group +visit +study group\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in S-PMA||16.3|-40.4|0.4014
70890912|NCT04079933|141267563|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in carboxyhemoglobin|Mean Difference (Net)|-0.507||||0.0241|TWO_SIDED|95.0|-0.946|-0.0674|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Change from baseline = study group + visit + study group\*visit + subject +random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in carboxyhemoglobin||-0.0674|-0.946|0.0241
70890913|NCT04079933|141267563|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in carboxyhemoglobin|Mean Difference (Net)|-0.367||||0.1292|TWO_SIDED|95.0|-0.843|0.108|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in carboxyhemoglobin||0.108|-0.843|0.1292
70890914|NCT04079933|141267564|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin|Mean Difference (Net)|-10.0||||0.0333|TWO_SIDED|95.0|-19.2|-0.803|||t-test, 2 sided||"Difference in Least Square means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Percent Change from baseline = study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin||-0.803|-19.2|0.0333
70890915|NCT04079933|141267564|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin|Mean Difference (Net)|-6.76||||0.1767|TWO_SIDED|95.0|-16.6|3.08|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~%Change from baseline = study group +visit +study group\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin||3.08|-16.6|0.1767
70890916|NCT04079933|141267565|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in exhaled carbon monoxide|Mean Difference (Net)|-1.51||||0.2961|TWO_SIDED|95.0|-4.36|1.34|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Change from baseline = study group + visit + study group\*visit + subject +random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in exhaled carbon monoxide||1.34|-4.36|0.2961
70890917|NCT04079933|141267565|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in exhaled carbon monoxide|Mean Difference (Net)|-1.05||||0.5015|TWO_SIDED|95.0|-4.12|2.03|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in exhaled carbon monoxide||2.03|-4.12|0.5015
70890918|NCT04079933|141267566|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in exhaled carbon monoxide|Mean Difference (Net)|-12.1||||0.2048|TWO_SIDED|95.0|-30.9|6.68|||t-test, 2 sided||"Difference in Least Square means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Percent Change from baseline = study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in exhaled carbon monoxide||6.68|-30.9|0.2048
70890919|NCT04079933|141267566|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to control in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to control in exhaled carbon monoxide|Mean Difference (Net)|-7.32||||0.4731|TWO_SIDED|95.0|-27.4|12.8|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~%Change from baseline = study group +visit +study group\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to control in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to control in exhaled carbon monoxide||12.8|-27.4|0.4731
70890920|NCT04079933|141267567|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in cigarettes smoked per day|Mean Difference (Net)|-3.86|||<|0.0001|TWO_SIDED|95.0|-5.25|-2.47|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Change from baseline = study group + visit + study group\*visit + subject +random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in cigarettes smoked per day||-2.47|-5.25|<0.0001
70890921|NCT04079933|141267567|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in cigarettes smoked per day|Mean Difference (Net)|-3.74|||<|0.0001|TWO_SIDED|95.0|-5.14|-2.34|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in cigarettes smoked per day||-2.34|-5.14|<0.0001
70890922|NCT04079933|141267568|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day|Mean Difference (Net)|-22.5|||<|0.0001|TWO_SIDED|95.0|-30.5|-14.5|||t-test, 2 sided||"Difference in Least Square means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Percent Change from baseline = study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day||-14.5|-30.5|<0.0001
70890923|NCT04079933|141267568|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day|Mean Difference (Net)|-22.3|||<|0.0001|TWO_SIDED|95.0|-30.4|-14.1|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~%Change from baseline = study group +visit +study group\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day||-14.1|-30.4|<0.0001
70890924|NCT04079933|141267569|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence|Mean Difference (Net)|-0.408||||0.0919|TWO_SIDED|95.0|-0.884|0.0673|||t-test, 2 sided||"Difference in LS mean change between study groups using Mixed Effects Repeated Measures Model 1:~Change from baseline=study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence||0.0673|-0.884|0.0919
70890925|NCT04079933|141267569|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence|Mean Difference (Net)|-0.405||||0.0975|TWO_SIDED|95.0|-0.886|0.0751|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence||0.0751|-0.886|0.0975
70890926|NCT04079933|141267569|EQUIVALENCE|"Statistical Analysis of Difference in Percent Change from Baseline in Total Score of Fagerstrom Test for Cigarette Dependence between the Study Groups.~Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence"|Mean Difference (Net)|-8.31||||0.0643|TWO_SIDED|95.0|-17.1|0.499|||t-test, 2 sided||"Difference in LS mean percent change between study groups using Mixed Effects Repeated Measures Model 1:~Change from baseline=study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix"|"Statistical Analysis of Difference in Percent Change from Baseline in Total Score of Fagerstrom Test for Cigarette Dependence between the Study Groups.~Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence"||0.499|-17.1|0.0643
70890927|NCT04079933|141267569|EQUIVALENCE|"Statistical Analysis of Difference in Percent Change from Baseline in Total Score of Fagerstrom Test for Cigarette Dependence between the Study Groups.~Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence"|Mean Difference (Net)|-8.84||||0.0517|TWO_SIDED|95.0|-17.7|0.0661|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|"Statistical Analysis of Difference in Percent Change from Baseline in Total Score of Fagerstrom Test for Cigarette Dependence between the Study Groups.~Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence"||0.0661|-17.7|0.0517
70890928|NCT04079933|141267570|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change in quit attempts from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quit attempts from baseline to end of study|Probability|0.216||||0.216|TWO_SIDED||||||Fisher Exact||Estimated value is the probability of observed distribution assuming the null hypothesis|Null hypothesis = Test and Control groups will have equivalent levels of change in quit attempts from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quit attempts from baseline to end of study||||0.2160
70890929|NCT04079933|141267570|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change in quit attempts from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quit attempts from baseline to end of study|Probability|0.0648||||0.0648|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Null hypothesis = Test and Control groups will have equivalent levels of change in quit attempts from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quit attempts from baseline to end of study||||0.0648
70890930|NCT04079933|141267571|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change in quitting intentions from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quitting intentions from baseline to end of study|Probability|0.5977||||0.5977|TWO_SIDED||||||Fisher Exact||Estimated value is the probability of observed distribution assuming the null hypothesis|Null hypothesis = Test and Control groups will have equivalent levels of change in quitting intentions from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quitting intentions from baseline to end of study||||0.5977
70890931|NCT04079933|141267572|EQUIVALENCE|Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of NNAL; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of NNAL|Mean Difference (Net)|10.0||||0.4388|TWO_SIDED|95.0|-15.5|35.5|||t-test, 2 sided|||Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of NNAL; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of NNAL||35.5|-15.5|0.4388
70890932|NCT04079933|141267573|EQUIVALENCE|Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of nicotine metabolites; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of nicotine metabolites|Mean Difference (Net)|0.45||||0.339|TWO_SIDED|95.0|-0.48|1.38|||t-test, 2 sided|||Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of nicotine metabolites; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of nicotine metabolites||1.38|-0.48|0.3390
70890933|NCT04079933|141267574|EQUIVALENCE|Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of S-PMA; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of S-PMA|Mean Difference (Net)|-205.0||||0.4526|TWO_SIDED|95.0|-745.0|334.0|||t-test, 2 sided|||Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of S-PMA; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of S-PMA||334|-745|0.4526
70890934|NCT04079933|141267575|EQUIVALENCE|Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of carboxyhemoglobin; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of carboxyhemoglobin|Mean Difference (Net)|0.0||||0.944|TWO_SIDED|95.0|-0.2|0.2|||t-test, 2 sided|||Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of carboxyhemoglobin; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of carboxyhemoglobin||0.2|-0.2|0.9440
70890935|NCT04079933|141267576|EQUIVALENCE|Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of carbon monoxide; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of carbon monoxide|Mean Difference (Net)|0.0||||0.7484|TWO_SIDED|95.0|-1.0|1.0|||t-test, 2 sided|||Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of carbon monoxide; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of carbon monoxide||1|-1|0.7484
70890936|NCT04079933|141267577|EQUIVALENCE|Null hypothesis = Cigarette consumption (CPD) determined using the Day 1 (Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will be equivalent; Alternate hypothesis = Cigarette consumption (CPD) determined using the Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT be equivalent|Mean Difference (Net)|0.0||||0.9992|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Null hypothesis = Cigarette consumption (CPD) determined using the Day 1 (Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will be equivalent; Alternate hypothesis = Cigarette consumption (CPD) determined using the Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT be equivalent||0|0|0.9992
70890937|NCT04079933|141267599|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study|Probability|0.1661||||0.1661|TWO_SIDED||||||Cochran-Mantel-Haenszel||Estimated value is the probability of observed distribution assuming the null hypothesis|Null hypothesis = Test and Control groups will have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study||||0.1661
70890938|NCT04079933|141267599|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study|Probability|0.2139||||0.2139|TWO_SIDED||||||Fisher Exact||Estimated value is the probability of observed distribution assuming the null hypothesis|Null hypothesis = Test and Control groups will have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study||||0.2139
70890939|NCT05101252|141267635|SUPERIORITY|Superiority was declared if the upper limit of the 98.75% confidence interval of was below 0.00 logMAR for distance.|Least-square Mean|-0.08|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|98.75|-0.14|-0.01|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1.25% individually) with at least 90% statistical power, that 22 subjects were required to test for superiority for distance.||-0.01|-0.14|
70890940|NCT05101252|141267635|SUPERIORITY|Superiority was declared if the upper limit of the 98.75% confidence interval of was below 0.17 logMAR for intermediate.|Least-square Mean|0.0|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|98.75|-0.06|0.07|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1.25% individually) with at least 90% statistical power, that 12 subjects were required to test for superiority for intermediate.||0.07|-0.06|
70890941|NCT05101252|141267635|SUPERIORITY|Superiority was declared if the upper limit of the 98.75% confidence interval of was below 0.17 logMAR for near.|Least-square Mean|0.09|STANDARD_ERROR_OF_MEAN|0.023|||TWO_SIDED|98.75|0.02|0.16|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1.25% individually) with at least 90% statistical power, that 60 subjects were required to test for superiority for near.||0.16|0.02|
70890942|NCT05101252|141267636|SUPERIORITY|Superiority was declared if the lower bound of the 98.75% confidence interval was above 32.|Least-square Mean|50.8|STANDARD_ERROR_OF_MEAN|2.922|||TWO_SIDED|98.75|43.1|58.5|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1.25% individually) with at least 99% statistical power, that 13 subjects were required to test for superiority for CLUE vision scores.||58.5|43.1|
70890943|NCT05101252|141267637|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the 95% confidence interval of the least-square mean difference was below 0.05 logMAR.|LSM Difference|0.0|STANDARD_ERROR_OF_MEAN|0.024|||TWO_SIDED|95.0|-0.05|0.05|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|LSM difference was calculated as Test minus Control|It was calculated using a 2 independent sample means t-test with a 2-sided type I error rate of 5% with at least 95% statistical power, that 60 subjects were required to test for non-inferiority of the Test compared to the Control for distance (4m).||0.05|-0.05|
70890944|NCT01731171|141267662|OTHER|The effect of treatment was calculated using logistic regression and the Cox proportional hazard function employing age, gender, and race as covariates.|Cox Proportional Hazard|0.37|||=|0.029|TWO_SIDED|95.0|||||Regression, Logistic||Values less than one favor adjunctive probiotic treatment, while values higher than one favor the placebo.|||||=.029
70890945|NCT01731171|141267663|SUPERIORITY||||||=|0.022|||||||Chi-squared|||||||=.022
70890946|NCT01731171|141267664|SUPERIORITY||||||=|0.009|||||||Regression, Linear|||||||=.009
70890947|NCT01731171|141267665|SUPERIORITY||||||=|0.017|||||||Kruskal-Wallis|||||||=.017
70890948|NCT01736852|141267672|NON_INFERIORITY|non-inferiority margin of 10%, α = 0.025, power = 0.80,||||||0.06|||||||Fisher Exact|||.ample size calculations were performed using an expected rate of 4% for each group,a one-sided exact test, α = 0.025, power = 0.80, non-inferiority margin of 10% resulting in a sample size of 124 patients or 62 patients per treatment arm.||||0.06
70890949|NCT01168934|141267710|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|43.44|||||TWO_SIDED|90.0|39.68|47.56||||||Natural log transformed AUC (0 - ∞)(dn) of crizotinib was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||47.56|39.68|
70890950|NCT01168934|141267713|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|44.67|||||TWO_SIDED|90.0|40.9|48.78||||||Natural log transformed AUClast(dn) of crizotinib was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||48.78|40.90|
70890951|NCT01504438|141267728|OTHER|||||||0.29|||||||ANOVA|||||||0.29
70890952|NCT01504438|141267729|OTHER|||||||0.31|||||||ANOVA|||||||0.31
70890953|NCT01504438|141267730|OTHER|||||||0.07|||||||ANOVA|||||||0.07
70890954|NCT01504438|141267731|OTHER|||||||0.04|||||||ANOVA|||||||0.04
70890955|NCT03047447|141267782|OTHER|||||||0.001||||||Change over time from week 0 to week 10 with HgA1c for experimental ketogenic group vs.control exercise and non-exercise groups.|ANOVA|||||||0.001
70890956|NCT03047447|141267783|OTHER|||||||0.001|||||||ANOVA|Change over time from week 0 to week 10 with weight for experimental ketogenic group vs.control exercise and non-exercise groups.||||||0.001
70890957|NCT03047447|141267784|OTHER|||||||0.001|||||||ANOVA|Change over time from week 0 to week 10 with BMI for experimental ketogenic group vs.control exercise and non-exercise groups.||||||0.001
70890958|NCT03047447|141267785|OTHER|||||||0.001|||||||ANOVA|Change over time from week 0 to week 10 with body fat mass for experimental ketogenic group vs.control exercise and non-exercise groups.||||||0.001
70890959|NCT03047447|141267786|OTHER|||||||0.001|||||||ANOVA|Change over time from week 0 to week 10 with blood ketones for experimental ketogenic group vs.control exercise and non-exercise groups.||||||0.001
70890960|NCT00466193|141267831|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for treatment|ANCOVA|||||||<0.001
70890961|NCT00466193|141267833|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||p-value is for treatment|ANCOVA|||||||0.006
70890962|NCT00466193|141267836|SUPERIORITY_OR_OTHER|||||||0.0041||95.0||||P-value is for treatment|ANCOVA|||||||0.0041
70890963|NCT01175382|141267871|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis of Covariance used to compare mean changes from baseline to 6 weeks among groups adjusting for baseline values and age. Last Observation Carried Forward was used for imputation of missing data.||||<.0001
70890964|NCT01175382|141267872|SUPERIORITY_OR_OTHER|||||||0.0013|||||||ANCOVA|||Analysis of Covariance to test for differences in mean change from 6 weeks to 12 weeks in voiding frequency controlling for age and 6 week frequency. Last Observation Carried Forward was used to impute missing data.||||.0013
70890965|NCT01175382|141267873|SUPERIORITY_OR_OTHER|||||||0.2933|||||||ANCOVA|||Analysis of Covariance testing whether mean change in 24-hour voiding frequency differed among the groups after adjusting for baseline voiding frequency and age. Last Observation Carried Forward was used to impute missing data.||||0.2933
70890966|NCT01175382|141267874|SUPERIORITY_OR_OTHER|||||||0.0051|||||||ANCOVA|||Analysis of Covariance used to test means changes among the groups adjusting for baseline values and age. Last Observation Carried Forward was used to impute missing data.||||0.0051
70890967|NCT01175382|141267875|SUPERIORITY_OR_OTHER|||||||0.1402|||||||ANCOVA|||Analysis of Covariance comparing mean change score among groups controlling for age and baseline score||||.1402
70890968|NCT01175382|141267876|SUPERIORITY_OR_OTHER|||||||0.0015|||||||ANCOVA|||Analysis of Covariance comparing mean change in Nocturia among groups adjusting for baseline values of nocturia and age. Last Observation Carried Forward was used to impute missing data.||||0.0015
70890969|NCT01175382|141267877|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||Analysis of Covariance comparing mean change in Overactive Bladder Questionnaire from baseline to 6 weeks among groups after controlling for baseline value and age. Last Observation Carried Forward was used to impute missing data.||||<.0001
70890970|NCT01175382|141267878|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||"Analysis of Covariance comparing mean chance in IPSS from baseline to 6 weeks among groups controlling for baseline IPSS values and age.~Last Observation Carried Forward was used to impute missing data."||||<.0001
70890971|NCT01175382|141267879|SUPERIORITY_OR_OTHER|||||||0.0022|||||||Cochran-Mantel-Haenszel|||||||0.0022
70890972|NCT01175382|141267880|SUPERIORITY_OR_OTHER|||||||0.0222|||||||Cochran-Mantel-Haenszel|||||||.0222
70890973|NCT01175382|141267881|SUPERIORITY_OR_OTHER|||||||0.0217|||||||Cochran-Mantel-Haenszel|||||||.0217
70890974|NCT01175382|141267882|SUPERIORITY_OR_OTHER|||||||0.669|||||||ANCOVA|||Analysis of Covariance used to test whether mean changes in Urgency Score from 6 weeks to 12 weeks differed among groups after controlling for age and 6 week Urgency Score. Last Observation Carried Forward was used to impute missing values.||||0.6690
70890975|NCT01175382|141267883|SUPERIORITY_OR_OTHER|||||||0.0812|||||||ANCOVA|||Analysis of Covariance to test whether mean change in Incontinence Episodes from 6 weeks to 12 weeks differed among groups after controlling for age and frequency of incontinence episodes at 6 weeks. Last Observation Carried Forward was used to impute missing values.||||0.0812
70890976|NCT01175382|141267884|SUPERIORITY_OR_OTHER|||||||0.5578|||||||ANCOVA|||Analysis of Covariance used to test whether mean changes in nocturia from 6 weeks to 12 weeks differed among groups after controlling for age and 6 week nocturia frequency. Last Observation Carried Forward was used to impute missing values.||||0.5578
70890977|NCT01175382|141267885|SUPERIORITY_OR_OTHER|||||||0.0279|||||||ANCOVA|||Analysis of Covariance to test whether mean change in Overactive Bladder Questionnaire (OAB-q) from 6 to 12 weeks differed among groups after controlling for age and 6 week OAB-q score. Last Observation Carried Forward was used to impute missing values.||||0.0279
70890978|NCT01175382|141267886|SUPERIORITY_OR_OTHER|||||||0.2553|||||||ANCOVA|||Analysis of Covariance to test whether mean change in the International Prostate Symptom Scale (IPSS) from 6 to 12 weeks differed among groups||||0.2553
70890979|NCT01175382|141267887|SUPERIORITY_OR_OTHER|||||||0.3165|||||||Cochran-Mantel-Haenszel|||||||0.3165
70890980|NCT01175382|141267888|SUPERIORITY_OR_OTHER|||||||0.8153|||||||Cochran-Mantel-Haenszel|||||||0.8153
70890981|NCT01175382|141267889|SUPERIORITY_OR_OTHER|||||||0.5536|||||||Cochran-Mantel-Haenszel|||||||0.5536
70890982|NCT01175382|141267890|SUPERIORITY_OR_OTHER|||||||0.2035|||||||ANCOVA|||Analysis of Covariance testing whether mean change in Nocturia frequency differed among the groups after adjusting for baseline Nocturia frequency and age. Last Observation Carried Forward was used to impute missing data||||0.2035
70890983|NCT01175382|141267891|SUPERIORITY_OR_OTHER|||||||0.0549|||||||ANCOVA|||Analysis of Covariance testing whether mean change in Urgency Score differed among the groups after adjusting for Urgency Scoe and age. Last Observation Carried Forward was used to impute missing data||||.0549
70890984|NCT01175382|141267892|SUPERIORITY_OR_OTHER|||||||0.507|||||||ANCOVA|||Analysis of Covariance testing whether mean change in Incontinent Episodes differed among the groups after adjusting for baseline Incontinent episodes frequency and age. Last Observation Carried Forward was used to impute missing data||||0.5070
70890985|NCT01175382|141267893|SUPERIORITY_OR_OTHER|||||||0.0529|||||||ANCOVA|||Analysis of Covariance testing whether mean change in Overactive Bladder Questionnaire differed among the groups after adjusting for baseline Overactive Bladder Questionnaire Score and age. Last Observation Carried Forward was used to impute missing data||||.0529
70890986|NCT01175382|141267894|SUPERIORITY_OR_OTHER|||||||0.2384|||||||ANCOVA|||Analysis of Covariance to test whether mean change in International Prostate Symptom Score from Baseline to 12 weeks differed among groups after controlling for baseline International Prostate Symptom Score and age. Last Observation Carried Forward was used to impute missing values.||||0.2384
70890987|NCT02203019|141267925|EQUIVALENCE|Outcome comparison used the Mann Whitney U test||||||0.107|||||||Wilcoxon (Mann-Whitney)|||||||0.107
70890988|NCT02203019|141267926|EQUIVALENCE|Outcomes were compared using a Mann Whitney U test.||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.260
70890989|NCT02203019|141267927|EQUIVALENCE|Outcomes were compared using a Mann Whitney U test.||||||0.376|||||||Wilcoxon (Mann-Whitney)|||||||0.376
70890990|NCT02203019|141267928|EQUIVALENCE|Outcomes were compared using a Chi square test.||||||0.739|||||||Chi-squared|||||||0.739
70890991|NCT02031276|141267929|OTHER||difference in percentage of participants|12.6||||0.0955|TWO_SIDED|95.0|-2.2|27.5|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-tumor necrosis factor (anti-TNF) exposure.||27.5|-2.2|0.0955
70890992|NCT02031276|141267930|OTHER||difference in percentage of participants|13.4||||0.1151|TWO_SIDED|95.0|-3.3|30.1|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-TNF exposure.||30.1|-3.3|0.1151
70890993|NCT02031276|141267931|OTHER||difference in percentage of participants|12.0||||0.0057|TWO_SIDED|95.0|3.5|20.6|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-TNF exposure.||20.6|3.5|0.0057
70890994|NCT02031276|141267932|OTHER||difference in percentage of participants|18.7||||0.0104|TWO_SIDED|95.0|4.4|33.0|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-TNF exposure.||33.0|4.4|0.0104
70890995|NCT02031276|141267933|OTHER||difference in percentage of participants|2.4||||0.4977|TWO_SIDED|95.0|-4.5|9.2|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-TNF exposure.||9.2|-4.5|0.4977
70890996|NCT02031276|141267934|OTHER||difference in percentage of participants|7.4||||0.0107|TWO_SIDED|95.0|1.7|13.0|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-TNF exposure.||13.0|1.7|0.0107
70890997|NCT01148810|141267935|SUPERIORITY_OR_OTHER||Bayesian analysis|0.96|||||||||||||||Probability that the difference (BAF312-Placebo) is greater than the threshold|||
70890998|NCT01854554|141267946|SUPERIORITY|||||||0.74|||||||Gray's test|Cumulative Incidence Function treating progressive disease (RANO) or death before cognitive function decline as a competing risk.||||||.74
70890999|NCT01854554|141267947|SUPERIORITY|||||||0.6|||||||Log Rank|||||||.60
70891000|NCT01854554|141267948|SUPERIORITY|||||||0.24|||||||Log Rank|||||||0.24
70891001|NCT02509624|141267950|OTHER||%Geometric least-square mean(GLSM) ratio|105.08|||||TWO_SIDED|90.0|77.08|143.23||||||AUCinf of selonsertib||143.23|77.08|
70891002|NCT02509624|141267950|OTHER||% GLSM ratio|142.65|||||TWO_SIDED|90.0|120.52|168.84||||||AUCinf of selonsertib||168.84|120.52|
70891003|NCT02509624|141267950|OTHER||% GLSM ratio|110.55|||||TWO_SIDED|90.0|86.99|140.49||||||AUCinf of selonsertib||140.49|86.99|
70891004|NCT02509624|141267950|OTHER||% GLSM ratio|62.05|||||TWO_SIDED|90.0|43.84|87.81||||||AUCinf of GS-607509||87.81|43.84|
70891005|NCT02509624|141267950|OTHER||% GLSM ratio|66.44|||||TWO_SIDED|90.0|36.72|120.21||||||AUCinf of GS-607509||120.21|36.72|
70891006|NCT02509624|141267950|OTHER||% GLSM ratio|103.46|||||TWO_SIDED|90.0|51.75|206.83||||||AUCinf of GS-607509||206.83|51.75|
70891007|NCT02509624|141267951|OTHER||% GLSM ratio|99.87|||||TWO_SIDED|90.0|73.38|135.92||||||AUClast of selonsertib||135.92|73.38|
70891008|NCT02509624|141267951|OTHER||% GLSM ratio|141.75|||||TWO_SIDED|90.0|118.5|169.55||||||AUClast of selonsertib||169.55|118.50|
70891009|NCT02509624|141267951|OTHER||% GLSM ratio|112.24|||||TWO_SIDED|90.0|87.69|143.65||||||AUClast of selonsertib||143.65|87.69|
70891010|NCT02509624|141267951|OTHER||% GLSM ratio|61.2|||||TWO_SIDED|90.0|43.06|86.98||||||AUClast of GS-607509||86.98|43.06|
70891011|NCT02509624|141267951|OTHER||% GLSM ratio|61.07|||||TWO_SIDED|90.0|33.62|110.91||||||AUClast of GS-607509||110.91|33.62|
70891012|NCT02509624|141267951|OTHER||% GLSM ratio|96.13|||||TWO_SIDED|90.0|48.47|190.67||||||AUClast of GS-607509||190.67|48.47|
70891013|NCT02509624|141267952|OTHER||% GLSM ratio|88.68|||||TWO_SIDED|90.0|74.83|105.1||||||Cmax of selonsertib||105.10|74.83|
70891014|NCT02509624|141267952|OTHER||% GLSM ratio|91.16|||||TWO_SIDED|90.0|78.76|105.52||||||Cmax of selonsertib||105.52|78.76|
70891015|NCT02509624|141267952|OTHER||% GLSM ratio|100.19|||||TWO_SIDED|90.0|83.73|119.88||||||Cmax of selonsertib||119.88|83.73|
70891016|NCT02509624|141267952|OTHER||% GLSM ratio|71.44|||||TWO_SIDED|90.0|54.58|93.5||||||Cmax of GS-607509||93.50|54.58|
70891017|NCT02509624|141267952|OTHER||% GLSM ratio|46.92|||||TWO_SIDED|90.0|32.59|67.54||||||Cmax of GS-607509||67.54|32.59|
70891018|NCT02509624|141267952|OTHER||% GLSM ratio|93.93|||||TWO_SIDED|90.0|67.6|130.5||||||Cmax of GS-607509||130.50|67.60|
70891019|NCT00844194|141267961|SUPERIORITY_OR_OTHER||LSmean|-1.49|||<|0.0001|TWO_SIDED|95.0|-1.89|-1.1|||ANCOVA|with last observation carried forward (LOCF)||||-1.10|-1.89|< 0.0001
70891020|NCT00844194|141267961|SUPERIORITY_OR_OTHER||LSmean|-1.67|||<|0.0001|TWO_SIDED|95.0|-2.3|-1.04|||ANCOVA|||||-1.04|-2.30|< 0.0001
70891021|NCT00701389|141268073|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the 90% CI is less than 5 mmHg, the primary hypothesis would be supported.|Difference in Least Squares Means|1.5|||||TWO_SIDED|90.0|0.0|3.0|||Mixed Effect Model|||100 mg sumatriptan/600 mg telcagepant minus 100 mg sumatriptan/telcagepant placebo||3.0|0.0|
70891022|NCT00701389|141268074|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.2|||||TWO_SIDED|90.0|-0.2|2.7|||Mixed Effect Model|||sumatriptan placebo/600 mg telcagepant minus sumatriptan placebo/telcagepant placebo||2.7|-0.2|
70891023|NCT03669081|141268139|OTHER|The null hypothesis for the test was no difference between groups.||||||0.006||||||The significance level for this test was 0.05.|Wilcoxon (Mann-Whitney)|We used an exact Wilcoxon rank sum test due to the skewed nature of the morphine equivalents data and the small sample sizes in each group.||||||0.006
70891024|NCT03669081|141268140|OTHER|The null hypothesis was no difference between groups.||||||0.029|||||||Exact Wilcoxon rank sum test|||||||0.029
70891025|NCT03669081|141268141|NON_INFERIORITY|We conducted a 1-sided non-inferiority test using an alpha level of 0.025, for a comparison of the fold change of creatinine levels (pre-operative creatinine/post-operative creatinine) in the Toradol group. Our minimum non-inferiority margin was 0.5, ie the post-operative creatinine level could only increase to at most two times the pre-operative creatinine level.|||||<|0.0001||||||This p-value was compared to a significance threshold of 0.025.|Wilcoxon (Mann-Whitney)|||The safety outcome was used to power our study.To achieve 90% power at a 2.5% significance level for testing that the post-surgery creatinine increase is at most two-fold (where 1.5 fold is expected), or alternatively for the pre-surgery creatinine group to be ≥0.5 times the post-surgery, we need 17 subjects in the toradol group. This calculation was based on a non-inferiority test (one sided t-test) using a coefficient of variation of 0.25 based on preliminary data.||||<0.0001
70891026|NCT03669081|141268142|OTHER|The null hypothesis was no difference between groups.||||||0.002|||||||t-test, 2 sided|||||||0.002
70891027|NCT03669081|141268143|OTHER|The null hypothesis was no difference between groups.|||||>|0.99|||||||Fisher Exact|||||||>0.99
70891028|NCT00389324|141268146|NON_INFERIORITY_OR_EQUIVALENCE|The administration effect between SC and IV was assessed by exponentiation of the difference in least squares means between study phases (Test minus Reference) and the corresponding 90% confidence interval (CI) for the geometric LSM ratio between study phases (Test/Reference) for AUC. The Test (SC) was to be considered non-inferior to Reference (IV) if the lower bound of 90% CIs for the geometric LSM ratios of AUC between the Test and Reference was above 0.80 (80%).|Geometric Least Square Mean Ratio|0.888||||||90.0|0.861|0.917|||ANOVA||An adjusted steady-state area under the concentration vs. time curve following SC administration based on IV dosing schedule was calculated as AUC0-τ,SC multiplied by 3 or 4 for subjects on every-3-week or every-4-week IV dosing schedule.|The IV phase was considered as the Reference study phase and the SC phase as the Test study phase. The ANOVA included calculation of least-squares means (LSM), differences between adjusted means and the standard error associated with these differences.||0.917|0.861|
70891029|NCT04788147|141268167|OTHER|"The modified 3+3 design with 6 patients at the 'Recommended RefleXion FDG Dose level' aims to ensure that the observed proportion of patients below activity threshold to be less than 33%.~Probability of Observations at Most 1 of 6 below Activity Threshold True below activity rate 40% 30% 20% 10% Probability at most 1 of 6 patients below activity threshold 0.233 0.420 0.655 0.886"||||||||||||||||"Statistical analysis of the primary endpoint is not applicable to Cohort I. A modified 3+3 design was utilized wherein meeting the activity level threshold, not dose-limiting toxicity, is the endpoint. The RRFD is primarily based upon the lower FDG dose level where 5 to 6 out of 6 subjects have an Activity Concentration greater than 5 kBq/ml."|"Statistical analysis of the primary endpoint is not applicable to Cohort I. A modified 3+3 design was utilized wherein meeting the activity level threshold, not dose-limiting toxicity, is the endpoint. The RRFD is primarily based upon the lower FDG dose level where 5 to 6 out of 6 subjects have an Activity Concentration greater than 5 kBq/ml."|||
70891030|NCT02401672|141268184|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
70891031|NCT02401672|141268185|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
70891032|NCT02401672|141268186|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
70891033|NCT02401672|141268187|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
70891034|NCT03207750|141268198|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% Confidence Interval (CI) for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-D antibodies should be ≥-10%.|Difference in anti-D concentration|0.0|||||TWO_SIDED|95.0|-0.8|0.79||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective concentrations (≥ 0.1 IU/mL) of anti-D antibodies.||0.79|-0.80|
70891035|NCT03207750|141268198|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% Confidence Interval (CI) for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-T antibodies should be ≥-10%.|Difference in anti-T concentration|0.0|||||TWO_SIDED|95.0|-0.79|0.77||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective concentrations (≥ 0.1 IU/mL) of anti-T antibodies.||0.77|-0.79|
70891036|NCT03207750|141268199|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-HB antibodies should be ≥-10%.|Difference in anti-HB concentration|-0.65|||||TWO_SIDED|95.0|-1.9|0.16||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective concentrations (≥ 10 mIU/mL) of anti-HB antibodies.||0.16|-1.90|
70891037|NCT03207750|141268200|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-poliovirus type 1 antibodies should be ≥-5%.|Difference in anti-polio 1 concentration|0.21|||||TWO_SIDED|95.0|-0.6|1.15||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective titers (≥ 8 ED50) of anti-poliovirus type 1 antibodies.||1.15|-0.60|
70891038|NCT03207750|141268200|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-poliovirus type 2 antibodies should be ≥-5%.|Difference in anti-polio 2 concentration|-0.01|||||TWO_SIDED|95.0|-1.02|0.98||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective titers (≥ 8 ED50) of anti-poliovirus type 2 antibodies.||0.98|-1.02|
70891039|NCT03207750|141268200|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-poliovirus type 3 antibodies should be ≥-5%.|Difference in anti-polio 3 concentration|0.0|||||TWO_SIDED|95.0|-0.87|0.84||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective titers (≥ 8 ED50) of anti-poliovirus type 3 antibodies.||0.84|-0.87|
70891040|NCT03207750|141268201|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for each of anti-PT antibodies should be ≥ 0.67.|GMC ratio|0.94|||||TWO_SIDED|95.0|0.86|1.03|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for anti-PT antibodies.||1.03|0.86|
70891041|NCT03207750|141268201|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for each of anti-FHA antibodies should be ≥ 0.67.|GMC ratio|1.0|||||TWO_SIDED|95.0|0.92|1.08|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for anti-FHA antibodies.||1.08|0.92|
70891042|NCT03207750|141268201|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for each of anti-PRN antibodies should be ≥ 0.67.|GMC ratio|0.97|||||TWO_SIDED|95.0|0.86|1.1|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for anti-PRN antibodies.||1.10|0.86|
70891043|NCT03207750|141268202|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 1 should be ≥ 0.5.|GMC ratio|1.03|||||TWO_SIDED|95.0|0.93|1.14|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 1.||1.14|0.93|
70891044|NCT03207750|141268202|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 3 should be ≥ 0.5.|GMC ratio|1.0|||||TWO_SIDED|95.0|0.91|1.11|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 3.||1.11|0.91|
70891045|NCT03207750|141268202|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 4 should be ≥ 0.5.|GMC ratio|0.99|||||TWO_SIDED|95.0|0.9|1.09|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 4.||1.09|0.90|
70891046|NCT03207750|141268202|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 5 should be ≥ 0.5.|GMC ratio|1.05|||||TWO_SIDED|95.0|0.94|1.17|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 5.||1.17|0.94|
70891047|NCT03207750|141268202|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 6A should be ≥ 0.5.|GMC ratio|1.01|||||TWO_SIDED|95.0|0.92|1.12|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 6A.||1.12|0.92|
70891048|NCT03207750|141268202|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 6B should be ≥ 0.5.|GMC ratio|0.96|||||TWO_SIDED|95.0|0.83|1.12|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 6B.||1.12|0.83|
70891049|NCT03207750|141268202|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 7F should be ≥ 0.5.|GMC ratio|0.99|||||TWO_SIDED|95.0|0.91|1.08|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 7F.||1.08|0.91|
70891050|NCT03207750|141268202|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 9V should be ≥ 0.5.|GMC ratio|1.03|||||TWO_SIDED|95.0|0.93|1.14|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 9V.||1.14|0.93|
70891051|NCT03207750|141268202|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 14 should be ≥ 0.5.|GMC ratio|1.0|||||TWO_SIDED|95.0|0.89|1.13|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 14.||1.13|0.89|
70891052|NCT03207750|141268202|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 18C should be ≥ 0.5.|GMC ratio|1.03|||||TWO_SIDED|95.0|0.92|1.14|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 18C.||1.14|0.92|
70891053|NCT03207750|141268202|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 19A should be ≥ 0.5.|GMC ratio|1.04|||||TWO_SIDED|95.0|0.93|1.15|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 19A.||1.15|0.93|
70891054|NCT03207750|141268202|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 19F should be ≥ 0.5.|GMC ratio|1.03|||||TWO_SIDED|95.0|0.95|1.12|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 19F.||1.12|0.95|
70891055|NCT03207750|141268202|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 23F should be ≥ 0.5.|GMC ratio|0.98|||||TWO_SIDED|95.0|0.87|1.1|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 23F.||1.10|0.87|
70891056|NCT03207750|141268203|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentrations (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-PRP antibodies should be ≥-5%.|Difference in anti-PRP concentration|0.17|||||TWO_SIDED|95.0|-1.94|2.28||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with concentrations (≥ 0.15 µg/mL) of anti-PRP antibodies.||2.28|-1.94|
70891057|NCT03207750|141268204|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentrations (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-PRP antibodies should be ≥-10%.|Difference in anti-PRP concentration|-0.88|||||TWO_SIDED|95.0|-5.75|3.99||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with concentrations (≥ 1.0 µg/mL) of anti-PRP antibodies.||3.99|-5.75|
70891058|NCT03207750|141268205|OTHER|p-value on the difference in seroresponse (HRV PCV-free Liquid group minus HRV Lyophilized group) between groups should be \<=0.025 for PT antigen.|||||<|0.0001|||||||t-test, 1 sided|p-value was computed by integrating on p-values of 1 sided test with alpha=0.025 \& the posterior probability of the cut-off in HRV Lyophilized group||To rule out 10% decrease in seroresponse to PT antigen in subjects who received Pediarix co-administered with PCV-free-Liquid-HRV vaccine compared to subjects who received Pediarix co-administered with currently licensed lyophilized HRV vaccine where seroresponse was defined as percentage of subjects who showed a concentration above a threshold that led to 95% seroresponse in HRV lyophilized group.||||<.0001
70891059|NCT03207750|141268205|OTHER|p-value on the difference in seroresponse (HRV PCV-free Liquid group minus HRV Lyophilized group) between groups should be \<=0.025 for FHA antigen.|||||<|0.0001|||||||t-test, 1 sided|p-value was computed by integrating on p-values of 1 sided test with alpha=0.025 \& the posterior probability of the cut-off in HRV lyophilized group||To rule out 10% decrease in seroresponse to FHA antigen in subjects who received Pediarix co-administered with PCV-free-Liquid-HRV vaccine compared to subjects who received Pediarix co-administered with currently licensed lyophilized HRV vaccine where seroresponse was defined as percentage of subjects who showed a concentration above a threshold that led to 95% seroresponse in HRV lyophilized group.||||<.0001
70891060|NCT03207750|141268205|OTHER|p-value on the difference in seroresponse (HRV PCV-free Liquid group minus HRV Lyophilized group) between groups should be \<=0.025 for PRN antigen.|||||<|0.0001|||||||t-test, 1 sided|p-value was computed by integrating on p-values of 1 sided test with alpha=0.025 \& the posterior probability of the cut-off in HRV Lyophilized group||To rule out 10% decrease in seroresponse to PRN antigen in subjects who received Pediarix co-administered with PCV-free-Liquid-HRV vaccine compared to subjects who received Pediarix co-administered with currently licensed lyophilized HRV vaccine where seroresponse was defined as percentage of subjects who showed a concentration above a threshold that led to 95% seroresponse in HRV lyophilized group.||||<.0001
70891061|NCT01700946|141268222|SUPERIORITY|||||||0.035|||||||Log Rank|||||||0.035
70891062|NCT01700946|141268223|SUPERIORITY|||||||0.105|||||||Log Rank|||||||0.105
70891063|NCT01700946|141268224|SUPERIORITY|||||||0.1181|||||||Fisher Exact|||||||0.1181
70891064|NCT03321019|141268247|OTHER||F-statistic|8.59|||<|0.0001|TWO_SIDED|||||The p value was adjusted for multiple comparisons using Tukey's method.|ANOVA|Degree of freedom - 3, 278||Healthy controls were compared to PD participants across each of the 3 visits. PD participants were compared between visits 1, 2 and 3.||||<.0001
70891065|NCT03321019|141268248|OTHER||F-statistic|0.44||||0.72|TWO_SIDED|||||Tukey's method was used to control for multiple comparisons.|ANOVA|Degrees of freedom - 3. 278||Healthy controls were compared to PD participants across each of the 3 visits. PD participants were compared between visits 1, 2 and 3.||||0.72
70891066|NCT03321019|141268249|OTHER||F-statistic|3.048||||0.02|TWO_SIDED|||||Dunnett's T3 method was used to account for multiple comparisons.|ANOVA|degrees of freedom: 3, 229||Healthy controls were compared to PD participants across each of the 3 visits. PD participants were compared between visits 1, 2 and 3.||||0.02
70891067|NCT03321019|141268250|OTHER||F-statistic|2.939||||0.034|TWO_SIDED|||||The p value was adjusted in the analysis for multiple comparisons using Tukey's method.|ANOVA|Degrees of freedom - 3, 231||Healthy controls were compared to PD participants across each of the 3 visits. PD participants were compared between visits 1, 2 and 3.||||0.034
70891068|NCT03321019|141268251|OTHER||F-statistic|1.494||||0.022|TWO_SIDED|||||Tukey's method was used to adjust for multiple comparisons.|ANOVA|Degrees of freedom - 3, 274||Healthy controls were compared to PD participants across each of the 3 visits. PD participants were compared between visits 1, 2 and 3.||||0.022
70891069|NCT04289753|141268261|SUPERIORITY||Odds Ratio (OR)|0.56|||||TWO_SIDED|95.0|0.46|0.69||||||||0.69|0.46|
70891070|NCT04289753|141268262|SUPERIORITY||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.55|0.85||||||||0.85|0.55|
70891071|NCT04289753|141268263|SUPERIORITY||Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.7|1.0||||||||1.0|0.70|
70891072|NCT04102501|141268318|SUPERIORITY|||||||0.5858|||||||Mixed Models Analysis|||||||0.5858
70891073|NCT04102501|141268319|SUPERIORITY|||||||0.8061|||||||Mixed Models Analysis|||||||0.8061
70891074|NCT03191903|141268376|SUPERIORITY|||||||0.5874|||||||ANOVA|||||||0.5874
70891075|NCT03191903|141268377|SUPERIORITY|||||||0.0829|||||||ANOVA|||||||0.0829
70891076|NCT03191903|141268378|SUPERIORITY|||||||0.4673|||||||ANOVA|||||||0.4673
70891077|NCT03191903|141268379|SUPERIORITY|||||||0.9408|||||||ANOVA|||||||0.9408
70891078|NCT03191903|141268380|SUPERIORITY|||||||0.777|||||||ANOVA|||||||0.7770
70891079|NCT03191903|141268381|SUPERIORITY|||||||0.759|||||||ANOVA|||||||0.7590
70891080|NCT03191903|141268382|SUPERIORITY|||||||0.8309|||||||ANOVA|||||||0.8309
70891081|NCT03191903|141268383|SUPERIORITY|||||||0.6215|||||||ANOVA|||||||0.6215
70891082|NCT03191903|141268384|SUPERIORITY|||||||0.216|||||||ANOVA|||||||0.2160
70891083|NCT03191903|141268385|SUPERIORITY|||||||0.7026|||||||ANOVA|||||||0.7026
70891084|NCT03191903|141268386|SUPERIORITY|||||||0.0438|||||||ANOVA|||||||0.0438
70891085|NCT04369469|141268394|OTHER||Risk Difference (RD)|-0.0205||||0.6059|TWO_SIDED|95.0|-0.1703|0.1293||One-sided Mantel-Haenszel test of the difference in two proportions stratified by intubated or not intubated on Day 1 and a family-wise Type I error of 0.025.|Mantel Haenszel||Two-sided 95% confidence interval using the Sato variance estimator, combined overall imputations.|||0.1293|-0.1703|0.6059
70891086|NCT01344460|141268407|SUPERIORITY_OR_OTHER||Percentage difference|18.3|||<|0|TWO_SIDED|95.0|15.2||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Majority reader; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||15.2|<0.000
70891087|NCT01344460|141268407|SUPERIORITY_OR_OTHER||Percentage difference|16.4|||<|0|TWO_SIDED|95.0|13.2||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Blinded reader 1; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||13.2|<0.000
70891088|NCT01344460|141268407|SUPERIORITY_OR_OTHER||Percentage difference|24.0|||<|0|TWO_SIDED|95.0|20.5||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Blinded reader 2; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||20.5|<0.000
70891089|NCT01344460|141268407|SUPERIORITY_OR_OTHER||Percentage difference|17.4|||<|0|TWO_SIDED|95.0|14.3||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|||Blinded reader 3; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||14.3|<0.000
70891090|NCT01344460|141268407|SUPERIORITY_OR_OTHER||Percentage difference|25.6|||<|0|TWO_SIDED|95.0|21.9||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|||Clinical investigator; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||21.9|<0.000
70891091|NCT01344460|141268408|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|6.8|||||TWO_SIDED|95.0|-2.2||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Majority reader; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-2.2|
70891092|NCT01344460|141268408|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|0.0|||||TWO_SIDED|95.0|-9.7||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 1; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-9.7|
70891093|NCT01344460|141268408|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|14.3|||||TWO_SIDED|95.0|5.1||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 2; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||5.1|
70891094|NCT01344460|141268408|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|3.0|||||TWO_SIDED|95.0|-5.8||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 3; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-5.8|
70891095|NCT01344460|141268408|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|20.0|||||TWO_SIDED|95.0|11.7||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Clinical investigator; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||11.7|
70891096|NCT01344460|141268409|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|9.0|||||TWO_SIDED|95.0|7.0||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Majority reader; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||7.0|
70891097|NCT01344460|141268409|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|11.3|||||TWO_SIDED|95.0|9.1||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 1; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||9.1|
70891098|NCT01344460|141268409|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|9.7|||||TWO_SIDED|95.0|7.6||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 2; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||7.6|
70891099|NCT01344460|141268409|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|13.4|||||TWO_SIDED|95.0|11.2||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 3; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||11.2|
70891100|NCT01344460|141268409|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|13.1|||||TWO_SIDED|95.0|11.0||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Clinical investigator; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||11.0|
70891101|NCT01344460|141268410|SUPERIORITY_OR_OTHER||percentage|54.6|||||ONE_SIDED|95.0|46.2||||One sided 95% confidence interval|||Majority reader|||46.2|
70891102|NCT01344460|141268410|SUPERIORITY_OR_OTHER||percentage|51.6|||||ONE_SIDED|95.0|43.6||||One sided 95% confidence interval|||Blinded Reader 1|||43.6|
70891103|NCT01344460|141268410|SUPERIORITY_OR_OTHER||percentage|54.4|||||ONE_SIDED|95.0|45.5||||One sided 95% confidence interval|||Blinded Reader 2|||45.5|
70891104|NCT01344460|141268410|SUPERIORITY_OR_OTHER||percentage|53.4|||||ONE_SIDED|95.0|44.8||||One sided 95% confidence interval|||Blinded Reader 3|||44.8|
70891105|NCT01344460|141268410|SUPERIORITY_OR_OTHER||percentage|71.3|||||ONE_SIDED|95.0|64.7||||One sided 95% confidence interval|||Clinical investigator|||64.7|
70891106|NCT01344460|141268411|SUPERIORITY_OR_OTHER||percentage|95.9|||||ONE_SIDED|95.0|94.9||||One sided 95% confidence interval|||Majority reader|||94.9|
70891107|NCT01344460|141268411|SUPERIORITY_OR_OTHER||percentage|95.0|||||ONE_SIDED|95.0|93.8||||One sided 95% confidence interval|||Blinded Reader 1|||93.8|
70891108|NCT01344460|141268411|SUPERIORITY_OR_OTHER||percentage|96.2|||||ONE_SIDED|95.0|95.2||||One sided 95% confidence interval|||Blinded Reader 2|||95.2|
70891109|NCT01344460|141268411|SUPERIORITY_OR_OTHER||percentage|95.8|||||ONE_SIDED|95.0|94.8||||One sided 95% confidence interval|||Blinded Reader 3|||94.8|
70891110|NCT01344460|141268411|SUPERIORITY_OR_OTHER||percentage|98.4|||||ONE_SIDED|95.0|97.8||||One sided 95% confidence interval|||Clinical investigator|||97.8|
70891111|NCT01344460|141268414|SUPERIORITY_OR_OTHER||Diameter difference|0.17|STANDARD_DEVIATION|1.28|||||||||Mean Difference|||CTA Minus Unenhanced MRA for blinded Reader on vessel DIA at normal point||||
70891112|NCT01344460|141268414|SUPERIORITY_OR_OTHER||Diameter difference|-0.09|STANDARD_DEVIATION|1.14|||||||||Mean Difference|||CTA minus Gadobutrol-Enhanced MRA for blinded reader on vessel DIA at normal point||||
70891113|NCT01344460|141268414|SUPERIORITY_OR_OTHER||Mean Difference|0.41|STANDARD_DEVIATION|1.15|||||||||Mean Difference|||CTA minus Unenhanced MRA for blinded reader on vessel DIA at narrowest point||||
70891114|NCT01344460|141268414|SUPERIORITY_OR_OTHER||Diameter difference|-0.15|STANDARD_DEVIATION|1.01|||||||||Mean Difference|||CTA minus Gadobutrol-Enhanced MRA for blinded reader on vessel DIA at narrowest point||||
70891115|NCT03283670|141268429|SUPERIORITY||Mean Difference (Net)|-0.75||||0.55|TWO_SIDED||||||t-test, 2 sided|||HAMD-21 at 2 Hours, placebo vs 25% nitrous oxide||||0.55
70891116|NCT03283670|141268429|SUPERIORITY||Mean Difference (Net)|-1.4||||0.47|TWO_SIDED||||||t-test, 2 sided|||Change in HAMD-21, 25% nitrous oxide vs placebo at 24 hours||||0.47
70891117|NCT03283670|141268429|SUPERIORITY||Median Difference (Net)|-0.87||||0.49|TWO_SIDED||||||t-test, 2 sided|||HAMD-21 at 2 Hours, placebo vs 50% nitrous oxide||||0.49
70891118|NCT03283670|141268429|SUPERIORITY||Mean Difference (Net)|-1.9||||0.34|TWO_SIDED||||||t-test, 2 sided|||Change in HAMD-21 at 24 hours, placebo vs 50% nitrous oxide||||0.34
70891119|NCT03283670|141268429|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.94|TWO_SIDED||||||t-test, 2 sided|||Change in HAMD-21 at 2 hours, 25% nitrous oxide vs 50% nitrous oxide||||0.94
70891120|NCT03283670|141268429|SUPERIORITY||Mean Difference (Net)|-0.5||||0.8|TWO_SIDED||||||t-test, 2 sided|||Change in HAMD-21 at 24 hours, 25% nitrous oxide vs 50% nitrous oxide||||0.80
70891121|NCT01085318|141268430|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|864.1||||0.061|||||||Wilcoxon (Mann-Whitney)|||||||0.061
70891122|NCT01085318|141268431|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|644.99|||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70891123|NCT04286594|141268443|OTHER|Change in single group over time|Mean Difference (Final Values)|11.667|STANDARD_DEVIATION|5.051|<|0.001|TWO_SIDED|95.0|8.457|14.876|||t-test, 1 sided|||||14.876|8.457|<0.001
70891124|NCT00822510|141268526|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<.05
70891125|NCT00822510|141268528|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED|0.79|||||ANOVA|||||||.79
70891126|NCT00822510|141268529|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|0.001|||||ANOVA|||||||.001
70891127|NCT00822510|141268530|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|0.001|||||ANOVA|||||||.001
70891128|NCT00822510|141268531|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED|0.71|||||ANOVA|||||||.71
70891129|NCT00822510|141268532|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|0.01|||||ANOVA|||||||.01
70891130|NCT01404312|141268533|NON_INFERIORITY|"Non-inferiority margin: 1.25 events per 100 person-years.~Sample size determination was based on the assumption of a primary endpoint rate of 2.0/100 person-years, with a one-sided 0.025 alpha level, and targeting at least 90% power. This required a sample size of approximately 2500. The sample size was adjusted upwards to account for loss to follow-up, interim monitoring, and to allow for subgroup analyses with reasonable power."|Incidence Rate Difference|-0.0231|||||TWO_SIDED|95.1|-0.346|0.3|||||"Estimate given as Incidence rate in Arm A - Incidence Rate in Arm B (negative favors Arm A).~Incidence rate units: Events per 100 person-years"|Mantel-Haenszel method used for estimating standardized incidence rate in each arm and incidence rate difference.||0.300|-0.346|
70891131|NCT01404312|141268534|SUPERIORITY||Risk Difference (RD)|-0.016||||0.073|TWO_SIDED|95.0|-0.035|0.002||Not adjusted for multiple comparisons.|Fisher Exact||Estimate given as: Proportion Arm A - Proportion Arm B|"Comparison of the proportion of participants with any SAE occurrence between arms A and B.~H0: Proportion of participants with SAE in Arm A = Proportion of participants with SAE in Arm B."||0.002|-0.035|0.073
70891132|NCT01404312|141268535|SUPERIORITY||Risk Difference (RD)|-0.0058||||0.405|TWO_SIDED|95.0|-0.019|0.007||Not adjusted for multiple comparisons|Fisher Exact||Estimate given as: Proportion Arm A - Proportion Arm B|"Comparison of the proportion of participants with any targeted adverse event occurrence between arms A and B.~H0: Proportion of participants with a targeted adverse event in Arm A = Proportion of participants with a targeted adverse event in Arm B."||0.007|-0.019|0.405
70891133|NCT01404312|141268536|SUPERIORITY||Odds Ratio (OR)|2.093|||||TWO_SIDED|95.0|1.315|3.332|||||"Estimate given as: Odds of being in higher category (more stringent management due to toxicity) for Arm B compared with arm A~Not adjusted for multiple comparisons."|"Odds ratio of being in higher category estimated from proportional odds model~H0: Odds ratio of being in higher category for Arm A vs Arm B = 1"||3.332|1.315|
70891134|NCT01404312|141268537|SUPERIORITY|||||||0.3078||||||Not adjusted for multiple comparisons|Log Rank|||H0: Survival curve Arm A = Survival curve Arm B||||0.3078
70891135|NCT01404312|141268538|SUPERIORITY||Hazard Ratio (HR)|1.396||||0.2802|TWO_SIDED|95.0|0.762|2.559||Not adjusted for multiple comparisons|Hazard Ratio||Hazard ratio given as: Arm B hazard / Arm A hazard, i.e. HR \> 1 favors arm A|"Competing risk analysis using the Fine-Gray model, treating TB-related deaths as competing risks, and other deaths including deaths of unknown cause as the event of interest.~H0: Hazard Ratio for Arm A vs Arm B = 1"||2.559|0.762|0.2802
70891136|NCT04419493|141268544|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%|Geometric Least Squares Mean ratio (%)|102.2|STANDARD_ERROR_OF_MEAN|10.8|||TWO_SIDED|92.83|94.87|110.1|||||Geometric Least Squares Mean ratio is: Alteplase, TPA-02/Alteplase, TPA-05. Standard Error of the mean is actually the intra-individual geometric coefficient variation.|"The null hypothesis was that the ratio of expected geometric least squares means Alteplase, TPA-02 vs. Alteplase, TPA-05 is less than 80.00% or more than 125.00%.~The statistical model used for the analysis of this endpoints was an analysis of variance (ANOVA) model on the logarithmic scale.~This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. All effects were considered as fixed."||110.10|94.87|
70891137|NCT04419493|141268546|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%|Geometric Least Squares Mean ratio (%)|105.81|STANDARD_ERROR_OF_MEAN|9.3|||TWO_SIDED|92.83|99.18|112.88|||||Geometric Least Squares Mean ratio is: Alteplase, TPA-02/Alteplase, TPA-05. Standard Error of the mean is actually the intra-individual geometric coefficient variation.|"The null hypothesis was that the ratio of expected geometric least squares means Alteplase, TPA-02 vs. Alteplase, TPA-05 is less than 80.00% or more than 125.00%.~The statistical model used for the analysis of this endpoints was an analysis of variance (ANOVA) model on the logarithmic scale.~This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. All effects were considered as fixed."||112.88|99.18|
70891138|NCT04419493|141268548|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00% .|Geometric Least Squares Mean ratio (%)|102.17|STANDARD_ERROR_OF_MEAN|10.8|||TWO_SIDED|92.83|94.79|110.12|||||Geometric Least Squares Mean ratio is: Alteplase, TPA-02/Alteplase, TPA-05. Standard Error of the mean is actually the intra-individual geometric coefficient variation.|"The null hypothesis was that the ratio of expected geometric least squares means Alteplase, TPA-02 vs. Alteplase, TPA-05 is less than 80.00% or more than 125.00%.~The statistical model used for the analysis of this endpoints was an analysis of variance (ANOVA) model on the logarithmic scale.~This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. All effects were considered as fixed."||110.12|94.79|
70891139|NCT03320070|141268582|SUPERIORITY|||||||0.5076|||||||Chi-squared|||||||0.5076
70891140|NCT03320070|141268584|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0000
70891141|NCT03320070|141268586|SUPERIORITY|||||||0.0848|||||||Chi-squared|||||||0.0848
70891142|NCT03320070|141268588|SUPERIORITY|||||||0.2005|||||||Chi-squared|||||||0.2005
70891143|NCT03320070|141268590|SUPERIORITY|||||||0.9416|||||||Chi-squared|||||||0.9416
70891144|NCT03320070|141268592|SUPERIORITY|||||||0.1853|||||||Chi-squared|||||||0.1853
70891145|NCT00996996|141268594|SUPERIORITY_OR_OTHER||Percentage of participants|95.0|||||TWO_SIDED|95.0|90.0|100.0|||||The estimated value represents the percentage of participants with a confirmed response.|||100|90|
70891146|NCT00996996|141268595|SUPERIORITY_OR_OTHER||Percentage of participants|97.0|||||TWO_SIDED|95.0|94.0|100.0|||||The estimated value represents the percentage of participants with a response.|||100|94|
70891147|NCT00996996|141268596|SUPERIORITY_OR_OTHER||Percentage of participants|70.0|||||TWO_SIDED|95.0|59.0|80.0|||||The estimated value represents the percentage of participants with a confirmed CR.|||80|59|
70891148|NCT00996996|141268596|SUPERIORITY_OR_OTHER||Percentage of participants|3.0|||||TWO_SIDED|95.0|0.0|6.0|||||The estimated value represents the percentage of participants with a confirmed CCR.|||6|0|
70891149|NCT00996996|141268596|SUPERIORITY_OR_OTHER||Percentage of participants|75.0|||||TWO_SIDED|95.0|65.0|85.0|||||The estimated value represents the percentage of participants with confirmed CR + confirmed CCR.|||85|65|
70891150|NCT00996996|141268596|SUPERIORITY_OR_OTHER||Percentage of participants|17.0|||||TWO_SIDED|95.0|9.0|26.0|||||The estimated value represents the percentage of participants with a confirmed PR.|||26|9|
70891151|NCT00996996|141268597|SUPERIORITY_OR_OTHER||Percentage of participants|74.0|||||TWO_SIDED|95.0|64.0|84.0|||||The estimated value represents the percentage of participants with a CR.|||84|64|
70891152|NCT00996996|141268597|SUPERIORITY_OR_OTHER||Percentage of participants|4.0|||||TWO_SIDED|95.0|0.0|8.0|||||The estimated value represents the percentage of participants with a CCR.|||8|0|
70891153|NCT00996996|141268597|SUPERIORITY_OR_OTHER||Percentage of participants|78.0|||||TWO_SIDED|95.0|68.0|87.0|||||The estimated value represents the percentage of participants with a CR + CCR.|||87|68|
70891154|NCT00996996|141268597|SUPERIORITY_OR_OTHER||Percentage of participants|20.0|||||TWO_SIDED|95.0|11.0|29.0|||||The estimated value represents the percentage of participants with a PR.|||29|11|
70891155|NCT02819726|141268623|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ration|95.33|||||TWO_SIDED|90.0|87.07|104.37||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model (ANOVA) with fixed effect for treatment||104.37|87.07|
70891156|NCT02819726|141268623|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|93.43|||||TWO_SIDED|90.0|85.54|102.15||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||102.15|85.54|
70891157|NCT02819726|141268623|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|98.06|||||TWO_SIDED|90.0|89.49|107.45||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model (ANOVA) with fixed effect for treatment||107.45|89.49|
70891158|NCT02819726|141268624|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|94.07|||||TWO_SIDED|90.0|86.91|101.81||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||101.81|86.91|
70891159|NCT02819726|141268624|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ration|94.39|||||TWO_SIDED|90.0|87.21|102.16||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||102.16|87.21|
70891160|NCT02819726|141268624|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|100.35|||||TWO_SIDED|90.0|92.68|108.65||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||108.65|92.68|
70891161|NCT02819726|141268625|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|96.31|||||TWO_SIDED|90.0|90.52|102.46||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||102.46|90.52|
70891162|NCT02819726|141268625|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|98.65|||||TWO_SIDED|90.0|92.64|105.05||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||105.05|92.64|
70891163|NCT02819726|141268625|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|102.43|||||TWO_SIDED|90.0|96.14|109.14||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||109.14|96.14|
70891164|NCT02819726|141268626|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|94.93|||||TWO_SIDED|90.0|89.03|101.23||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||101.23|89.03|
70891165|NCT02819726|141268626|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|98.75|||||TWO_SIDED|90.0|92.61|105.3||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||105.30|92.61|
70891166|NCT02819726|141268626|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|104.03|||||TWO_SIDED|90.0|97.54|110.95||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||110.95|97.54|
70891167|NCT02819726|141268627|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|89.08|||||TWO_SIDED|90.0|77.2|102.79||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||102.79|77.20|
70891168|NCT02819726|141268627|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|102.56|||||TWO_SIDED|90.0|88.72|118.56||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||118.56|88.72|
70891169|NCT02819726|141268627|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|115.13|||||TWO_SIDED|90.0|99.51|133.21||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||133.21|99.51|
70891170|NCT02819726|141268628|EQUIVALENCE|The equivalence between 2 study treatments would be declared if the two-sided 95% CI of the difference in change from baseline in DAS28-CRP at week 24 in entirely contained within the equivalence margin of \[-0.6,0.6\]|LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.134||0.2402|TWO_SIDED|95.0|-0.422|0.106|||ANCOVA|||Least square means and confidence intervals (CIs) were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only||0.106|-0.422|0.2402
70891171|NCT02819726|141268628|EQUIVALENCE|The equivalence between 2 study treatments would be declared if the two-sided 95% CI of the difference in change from baseline in DAS28-CRP at week 24 in entirely contained within the equivalence margin of \[-0.6,0.6\]|LS Means Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.135||0.1346|TWO_SIDED|95.0|-0.469|0.063|||ANCOVA|||Least square means and CIs were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only||0.063|-0.469|0.1346
70891172|NCT02819726|141268628|EQUIVALENCE|The equivalence between 2 study treatments would be declared if the two-sided 95% CI of the difference in change from baseline in DAS28-CRP at week 24 in entirely contained within the equivalence margin of \[-0.6,0.6\]|LS Means Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.137||0.7429|TWO_SIDED|95.0|-0.314|0.224|||ANCOVA|||Least square means and CIs were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only||0.224|-0.314|0.7429
70891173|NCT02819726|141268637|OTHER||LS Means Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.172||0.6068|TWO_SIDED|95.0|-0.428|0.25|||ANCOVA|||Week 52 (EOS). Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and Baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only.||0.250|-0.428|0.6068
70891174|NCT02819726|141268637|OTHER||LS Means Difference|0.09|STANDARD_ERROR_OF_MEAN|0.172||0.599|TWO_SIDED|95.0|-0.249|0.43|||ANCOVA|||Week 52 (EOS) Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and Baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only.||0.430|-0.249|0.5990
70891175|NCT02819726|141268637|OTHER||LS Means Difference|0.18|STANDARD_ERROR_OF_MEAN|0.175||0.3053|TWO_SIDED|95.0|-0.165|0.532|||ANCOVA|||Week 53 (EOS) MabThera vs Rituxan. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and Baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only.||0.532|-0.165|0.3053
70891176|NCT02819726|141268638|OTHER||Difference (%)|9.4|STANDARD_ERROR_OF_MEAN|7.22|||TWO_SIDED|95.0|-4.74|23.03||||||Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method.||23.03|-4.74|
70891177|NCT02819726|141268638|OTHER||Difference (%)|-2.5|STANDARD_ERROR_OF_MEAN|7.05|||TWO_SIDED|95.0|-15.95|11.22||||||Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method.||11.22|-15.95|
70891178|NCT02819726|141268638|OTHER||Difference (%)|-11.8|STANDARD_ERROR_OF_MEAN|7.26|||TWO_SIDED|95.0|-25.47|2.45||||||Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method.||2.45|-25.47|
70891179|NCT02819726|141268639|OTHER||Difference (%)|9.5|STANDARD_ERROR_OF_MEAN|6.87|||TWO_SIDED|95.0|-4.07|22.46||||||ACR20 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.||22.46|-4.07|
70891180|NCT02819726|141268639|OTHER||Difference (%)|3.5|STANDARD_ERROR_OF_MEAN|7.07|||TWO_SIDED|95.0|-10.22|17.03||||||ACR50 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.||17.03|-10.22|
70891181|NCT02819726|141268639|OTHER||Difference (%)|-5.9|STANDARD_ERROR_OF_MEAN|6.88|||TWO_SIDED|95.0|-19.1|7.51||||||ACR50 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.||7.51|-19.10|
70891182|NCT02819726|141268639|OTHER||Difference (%)|10.0|STANDARD_ERROR_OF_MEAN|5.78|||TWO_SIDED|95.0|-1.52|21.22||||||ACR70 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.||21.22|-1.52|
70891183|NCT02819726|141268639|OTHER||Difference|5.4|STANDARD_ERROR_OF_MEAN|6.08|||TWO_SIDED|95.0|-6.69|17.13||||||ACR70 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.||17.13|-6.69|
70891184|NCT02819726|141268639|OTHER||Difference (%)|-4.7|STANDARD_ERROR_OF_MEAN|5.58|||TWO_SIDED|92.0|-15.68|6.41||||||ACR70 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.||6.41|-15.68|
70891185|NCT02819726|141268640|OTHER||LS Means Difference|-1.28|STANDARD_ERROR_OF_MEAN|0.991||0.1997|TWO_SIDED|95.0|-3.23|0.671|||ANCOVA|||Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.||0.671|-3.230|0.1997
70891186|NCT02819726|141268640|OTHER||LS Means Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.996||0.9098|TWO_SIDED|95.0|-2.074|1.848|||ANCOVA|||Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.||1.848|-2.074|0.9098
70891187|NCT02819726|141268640|OTHER||LS Means Difference|1.17|STANDARD_ERROR_OF_MEAN|1.008||0.248|TWO_SIDED|95.0|-0.817|3.15|||ANCOVA|||Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.||3.150|-0.817|0.2480
70891188|NCT02819726|141268640|OTHER||LS Means Difference|-1.96|STANDARD_ERROR_OF_MEAN|1.5||0.1931|TWO_SIDED|95.0|-4.909|0.996|||ANCOVA|||Tender Joint Count (TJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.||0.996|-4.909|0.1931
70891189|NCT02819726|141268640|OTHER||LS Means Difference|-0.77|STANDARD_ERROR_OF_MEAN|1.5||-0.77|TWO_SIDED|95.0|-3.722|2.184|||ANCOVA|||Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.||2.184|-3.722|-0.77
70891190|NCT02819726|141268640|OTHER||LS Means Difference|1.19|STANDARD_ERROR_OF_MEAN|1.52||0.4352|TWO_SIDED|95.0|-1.805|4.18|||ANCOVA|||Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.||4.180|-1.805|0.4352
70891191|NCT02819726|141268641|OTHER||LS Means Difference|-4.16|STANDARD_ERROR_OF_MEAN|3.242||0.2008|TWO_SIDED|95.0|-10.541|2.226|||ANCOVA|||Week 52 (EOS) Physician's Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline)||2.226|-10.541|0.2008
70891192|NCT02819726|141268641|OTHER||LS Means Difference|-0.39|STANDARD_ERROR_OF_MEAN|3.242||-0.39|TWO_SIDED|95.0|-6.771|5.994|||ANOVA|||Week 52 (EOS) Physician's Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline||5.994|-6.771|-0.39
70891193|NCT02819726|141268641|OTHER||LS Means Difference|3.77|STANDARD_ERROR_OF_MEAN|3.268||0.2498|TWO_SIDED|95.0|-2.665|10.204|||ANCOVA|||Week 52 (EOS) Physician's Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline||10.204|-2.665|0.2498
70891194|NCT02819726|141268642|OTHER||LS Means Difference|-1.23|STANDARD_ERROR_OF_MEAN|3.592||0.7322|TWO_SIDED|95.0|-8.0302|5.841|||ANCOVA|||Week 52 (EOS) Participants Pain Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||5.841|-8.0302|0.7322
70891195|NCT02819726|141268642|OTHER||LS Means Difference|-2.21|STANDARD_ERROR_OF_MEAN|3.623||0.5418|TWO_SIDED|95.0|-9.347|4.92|||ANCOVA|||Week 52 (EOS) Participants Pain Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||4.920|-9.347|0.5418
70891196|NCT02819726|141268642|OTHER||LS Means Difference|-0.98|STANDARD_ERROR_OF_MEAN|3.633||0.7869|TWO_SIDED|95.0|-8.136|6.169|||ANCOVA|||Week 52 (EOS) Participants Pain Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||6.169|-8.136|0.7869
70891197|NCT02819726|141268643|OTHER||LS Means Difference|-1.28|STANDARD_ERROR_OF_MEAN|3.443||0.7097|TWO_SIDED|95.0|-8.062|5.496|||ANCOVA|||Week 52 (EOS) Participants Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline)||5.496|-8.062|0.7097
70891198|NCT02819726|141268643|OTHER||LS Means Difference|-1.48|STANDARD_ERROR_OF_MEAN|3.453||0.6683|TWO_SIDED|95.0|-8.28|5.317|||ANCOVA|||Week 52 (EOS) Participants Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline)||5.317|-8.280|0.6683
70891199|NCT02819726|141268643|OTHER||LS Means Difference|-0.2|STANDARD_ERROR_OF_MEAN|3.494||0.9548|TWO_SIDED|95.0|-7.078|6.682|||ANCOVA|||Week 52 (EOS) Participants Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline)||6.682|-7.078|0.9548
70891200|NCT02819726|141268644|OTHER||LS Means Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.086||0.0505|TWO_SIDED|95.0|-0.339|0.0|||ANCOVA|||Week 52 (EOS) HAQ-DI (0-3). Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||0.000|-0.339|0.0505
70891201|NCT02819726|141268644|OTHER||LS Means Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.086||0.1141|TWO_SIDED|95.0|-0.307|0.033|||ANCOVA|||Week 52 (EOS) HAQ-DI (0-3). Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||0.033|-0.307|0.1141
70891202|NCT02819726|141268644|OTHER||LS Means Difference|0.03|STANDARD_ERROR_OF_MEAN|0.087||0.7111|TWO_SIDED|95.0|-0.139|0.204|||ANCOVA|||Week 52 (EOS) HAQ-DI )0-3). Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||0.204|-0.139|0.7111
70891203|NCT02819726|141268645|OTHER||LS Means Difference|-0.43|STANDARD_ERROR_OF_MEAN|1.871||0.8183|TWO_SIDED|95.0|-4.113|3.253|||ANCOVA|||Week 52 (EOS) CRP. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||3.253|-4.113|0.8183
70891204|NCT02819726|141268645|OTHER||LS Means Difference|1.51|STANDARD_ERROR_OF_MEAN|1.868||0.4186|TWO_SIDED|95.0|-2.164|5.191|||ANCOVA|||Week 52 (EOS) CRP. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||5.191|-2.164|0.4186
70891205|NCT02819726|141268645|OTHER||LS Means Difference|1.94|STANDARD_ERROR_OF_MEAN|1.885||0.3035|TWO_SIDED|95.0|-1.768|5.655|||ANCOVA|||Week 52 (EOS) CRP. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||5.655|-1.768|0.3035
70891206|NCT02819726|141268646|OTHER||LS Means Difference|0.02|STANDARD_ERROR_OF_MEAN|0.2||0.9249|TWO_SIDED|95.0|-0.375|0.413|||ANCOVA|||Week 52 ( EOS) Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-ESR value as a covariate. ANCOVA model contains treatment group only.||0.413|-0.375|0.9249
70891207|NCT02819726|141268646|OTHER||LS Measn Difference|0.05|STANDARD_ERROR_OF_MEAN|0.201||0.05|TWO_SIDED|95.0|-0.351|0.442|||ANCOVA|||Week 52 ( EOS) Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-ESR value as a covariate. ANCOVA model contains treatment group only.||0.442|-0.351|0.05
70891208|NCT02819726|141268646|OTHER||LS Means Diference|0.03|STANDARD_ERROR_OF_MEAN|0.205||0.8962|TWO_SIDED|95.0|-0.376|0.43|||ANCOVA|||Week 52 ( EOS) Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-ESR value as a covariate. ANCOVA model contains treatment group only.||0.430|-0.376|0.8962
70891209|NCT02819726|141268647|OTHER||Difference (%)|2.2|STANDARD_ERROR_OF_MEAN|1.57|||TWO_SIDED|95.0|-2.56|7.83||||||Week 52 (EOS) Major Clinical Response. The 95% CIs for major clinical response rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.||7.83|-2.56|
70891210|NCT02819726|141268647|OTHER||Difference (%)|1.0|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|-4.74|6.67||||||Week 52 (EOS) Major Clinical Response. The 95% CIs for major clinical response rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.||6.67|-4.74|
70891211|NCT02819726|141268647|OTHER||Difference (%)|-1.3|STANDARD_ERROR_OF_MEAN|1.24|||TWO_SIDED|95.0|-6.75|3.39||||||Week 52 (EOS) Major Clinical Response. The 95% CIs for major clinical response rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.||3.39|-6.75|
70891212|NCT02819726|141268648|OTHER||Difference (%)|-1.2|STANDARD_ERROR_OF_MEAN|1.92|||TWO_SIDED|95.0|-6.9|3.9||||||Week 52 (EOS). Clinical remission is defined as score of Simplified Disease Activity Index (SDAI) smaller than 3.3. The 95% CIs for clinical remission rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.||3.90|-6.9|
70891213|NCT02819726|141268648|OTHER||Difference (%)|-1.2|STANDARD_ERROR_OF_MEAN|1.95|||TWO_SIDED|95.0|-7.07|3.86||||||Week 52 (EOS). Clinical remission is defined as score of Simplified Disease Activity Index (SDAI) smaller than 3.3. The 95% CIs for clinical remission rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.||3.86|-7.07|
70891214|NCT02819726|141268648|OTHER||Differnce (%)|-0.1|STANDARD_ERROR_OF_MEAN|2.27|||TWO_SIDED|95.0|-6.05|5.83||||||Week 52 (EOS). Clinical remission is defined as score of Simplified Disease Activity Index (SDAI) smaller than 3.3. The 95% CIs for clinical remission rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.||5.83|-6.05|
70891215|NCT02819726|141268649|OTHER||Difference (%)|1.3|STANDARD_ERROR_OF_MEAN|7.19|||TWO_SIDED|95.0|-12.59|15.1||||||Week 52 EULAR score 'Good'. EULAR (European League Against Rheumatism) response was classified using the individual amount of change in the DAS28-CRP score. The 95% CIs for EULAR response rate and treatment difference were derived using the Wilson Score method.||15.10|-12.59|
70891216|NCT02819726|141268649|OTHER||Difference (%)|0.2|STANDARD_ERROR_OF_MEAN|7.21|||TWO_SIDED|95.0|-13.75|14.03|||Difference (%)|||Week 52 EULAR score 'Good'. EULAR (European League Against Rheumatism) response was classified using the individual amount of change in the DAS28-CRP score. The 95% CIs for EULAR response rate and treatment difference were derived using the Wilson Score method.||14.03|-13.75|
70891217|NCT02819726|141268649|OTHER||Difference (%)|-1.1|STANDARD_ERROR_OF_MEAN|7.29|||TWO_SIDED|95.0|-15.14|12.91||||||Week 52 EULAR score 'Good'. EULAR (European League Against Rheumatism) response was classified using the individual amount of change in the DAS28-CRP score. The 95% CIs for EULAR response rate and treatment difference were derived using the Wilson Score method.||12.91|-15.14|
70891218|NCT02819726|141268655|OTHER|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day 15 \[AUEC(0-d15)\]|Statistical Comparisons Difference|22.1|||||TWO_SIDED|90.0|-137.1|181.3||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||181.3|-137.1|
70891219|NCT02819726|141268655|OTHER|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day 15 \[AUEC(0-d15)\]|Statistical Comparisons Difference|69.5|||||TWO_SIDED|90.0|-91.8|230.8||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||230.8|-91.8|
70891220|NCT02819726|141268655|OTHER|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day 15 \[AUEC(0-d15)\]|Statistical Comparisons Difference|47.4|||||TWO_SIDED|90.0|-112.5|207.2||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||207.2|-112.5|
70891221|NCT02819726|141268655|OTHER|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day week \[AUEC(0-w24)\]|Statistical Comparisons Difference|310.7|||||TWO_SIDED|90.0|-187.9|809.4||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||809.4|-187.9|
70891222|NCT02819726|141268655|OTHER|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day week \[AUEC(0-w24)\]|Statistical Comparisons Difference|296.1|||||TWO_SIDED|90.0|-213.8|806.1||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||806.1|-213.8|
70891223|NCT02819726|141268655|OTHER|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day week \[AUEC(0-w24)\]|Statistical Comparisons Difference|-14.6|||||TWO_SIDED|90.0|-527.4|498.2||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||498.2|-527.4|
70891224|NCT00406029|141268658|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.753|TWO_SIDED|95.0|-0.9|1.2||The alpha threshold for statistical significance is 0.049 (2-sided).|ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.9|0.753
70891225|NCT00406029|141268658|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.162|TWO_SIDED|95.0|-1.7|0.3||The alpha threshold for statistical significance is 0.049 (2-sided).|ANCOVA|||LS means treatment difference in change from baseline at endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-1.7|0.162
70891226|NCT00406029|141268658|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.049|TWO_SIDED|95.0|-2.1|0.0||The alpha threshold for statistical significance is 0.049 (2-sided).|ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.0|-2.1|0.049
70891227|NCT00406029|141268658|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.2||||0.019|TWO_SIDED|95.0|-2.2|-0.2||The alpha threshold for statistical significance is 0.049 (2-sided).|ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.2|-2.2|0.019
70891228|NCT00406029|141268659|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.935|TWO_SIDED|95.0|-0.9|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-0.9|0.935
70891229|NCT00406029|141268659|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.326|TWO_SIDED|95.0|-1.3|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-1.3|0.326
70891230|NCT00406029|141268659|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.07|TWO_SIDED|95.0|-1.7|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-1.7|0.070
70891231|NCT00406029|141268659|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.02|TWO_SIDED|95.0|-1.9|-0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.2|-1.9|0.020
70891232|NCT00406029|141268659|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.982|TWO_SIDED|95.0|-1.0|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-1.0|0.982
70891233|NCT00406029|141268659|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.281|TWO_SIDED|95.0|-1.5|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-1.5|0.281
70891234|NCT00406029|141268659|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.261|TWO_SIDED|95.0|-1.6|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-1.6|0.261
70891235|NCT00406029|141268659|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.447|TWO_SIDED|95.0|-1.4|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-1.4|0.447
70891236|NCT00406029|141268659|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.378|TWO_SIDED|95.0|-0.6|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.6|0.378
70891237|NCT00406029|141268659|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.299|TWO_SIDED|95.0|-1.7|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-1.7|0.299
70891238|NCT00406029|141268659|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.377|TWO_SIDED|95.0|-1.6|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-1.6|0.377
70891239|NCT00406029|141268659|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.707|TWO_SIDED|95.0|-1.3|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-1.3|0.707
70891240|NCT00406029|141268659|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.562|TWO_SIDED|95.0|-1.4|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-1.4|0.562
70891241|NCT00406029|141268659|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.156|TWO_SIDED|95.0|-1.7|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-1.7|0.156
70891242|NCT00406029|141268659|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.292|TWO_SIDED|95.0|-1.6|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-1.6|0.292
70891243|NCT00406029|141268659|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.2||||0.034|TWO_SIDED|95.0|-2.2|-0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.1|-2.2|0.034
70891244|NCT00406029|141268659|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.762|TWO_SIDED|95.0|-0.9|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.9|0.762
70891245|NCT00406029|141268659|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9||||0.092|TWO_SIDED|95.0|-1.9|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-1.9|0.092
70891246|NCT00406029|141268659|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.3||||0.013|TWO_SIDED|95.0|-2.3|-0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.3|-2.3|0.013
70891247|NCT00406029|141268659|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5||||0.005|TWO_SIDED|95.0|-2.5|-0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.4|-2.5|0.005
70891248|NCT00406029|141268659|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.293|TWO_SIDED|95.0|-1.8|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-1.8|0.293
70891249|NCT00406029|141268659|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9||||0.095|TWO_SIDED|95.0|-2.0|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-2.0|0.095
70891250|NCT00406029|141268659|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.2||||0.04||95.0|-2.3|-0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.1|-2.3|0.040
70891251|NCT00406029|141268659|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.4||||0.011|TWO_SIDED|95.0|-2.5|-0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.3|-2.5|0.011
70891252|NCT00406029|141268660|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.47|TWO_SIDED|95.0|-0.6|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.6|0.470
70891253|NCT00406029|141268660|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.505|TWO_SIDED|95.0|-0.6|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.6|0.505
70891254|NCT00406029|141268660|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.114|TWO_SIDED|95.0|-0.2|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-0.2|0.114
70891255|NCT00406029|141268660|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.042|TWO_SIDED|95.0|0.0|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|0.0|0.042
70891256|NCT00406029|141268660|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.684|TWO_SIDED|94.0|-0.8|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-0.8|0.684
70891257|NCT00406029|141268660|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.489|TWO_SIDED|95.0|-0.7|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-0.7|0.489
70891258|NCT00406029|141268660|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.305|TWO_SIDED|95.0|-0.5|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.5|0.305
70891259|NCT00406029|141268660|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.451|TWO_SIDED|95.0|-0.6|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-0.6|0.451
70891260|NCT00406029|141268660|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.68|TWO_SIDED|95.0|-1.5|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-1.5|0.680
70891261|NCT00406029|141268660|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.466|TWO_SIDED|95.0|-0.8|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.8|0.466
70891262|NCT00406029|141268660|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.45|TWO_SIDED|95.0|-0.8|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-0.8|0.450
70891263|NCT00406029|141268660|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.523|TWO_SIDED|95.0|-0.8|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.8|0.523
70891264|NCT00406029|141268660|SUPERIORITY_OR_OTHER||Difference in LS Means|0.6||||0.309|TWO_SIDED|95.0|-0.6|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-0.6|0.309
70891265|NCT00406029|141268660|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.136|TWO_SIDED|95.0|-0.3|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-0.3|0.136
70891266|NCT00406029|141268660|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.106|TWO_SIDED|95.0|-0.2|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-0.2|0.106
70891267|NCT00406029|141268660|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.144|TWO_SIDED|95.0|-0.3|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-0.3|0.144
70891268|NCT00406029|141268660|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.954|TWO_SIDED|95.0|-1.1|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-1.1|0.954
70891269|NCT00406029|141268660|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.152|TWO_SIDED|95.0|-0.3|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-0.3|0.152
70891270|NCT00406029|141268660|SUPERIORITY_OR_OTHER||Difference in LS Means|1.4||||0.012|TWO_SIDED|95.0|0.3|2.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.4|0.3|0.012
70891271|NCT00406029|141268660|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.025|TWO_SIDED|95.0|0.2|2.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.3|0.2|0.025
70891272|NCT00406029|141268660|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.151|TWO_SIDED|95.0|-0.3|2.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.2|-0.3|0.151
70891273|NCT00406029|141268660|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.235|TWO_SIDED|95.0|-0.5|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-0.5|0.235
70891274|NCT00406029|141268660|SUPERIORITY_OR_OTHER||Difference in LS Means|1.7||||0.007|TWO_SIDED|95.0|0.5|2.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.9|0.5|0.007
70891275|NCT00406029|141268660|SUPERIORITY_OR_OTHER||Difference in LS Means|1.3||||0.033|TWO_SIDED|95.0|0.1|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|0.1|0.033
70891276|NCT00406029|141268660|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.757|TWO_SIDED|95.0|-0.9|1.2|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.9|0.757
70891277|NCT00406029|141268660|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.341|TWO_SIDED|95.0|-0.5|1.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.5|0.341
70891278|NCT00406029|141268660|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.024|TWO_SIDED|95.0|0.2|2.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.3|0.2|0.024
70891279|NCT00406029|141268660|SUPERIORITY_OR_OTHER||Difference in LS Means|1.1||||0.049|TWO_SIDED|95.0|0.0|2.1|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|0.0|0.049
70891280|NCT00406029|141268661|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.151|TWO_SIDED|95.0|-0.3|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-0.3|0.151
70891281|NCT00406029|141268661|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.93|TWO_SIDED|95.0|-1.1|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-1.1|0.930
70891282|NCT00406029|141268661|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.343|TWO_SIDED|95.0|-0.6|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.6|0.343
70891283|NCT00406029|141268661|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.746|TWO_SIDED|95.0|-0.9|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.9|0.746
70891284|NCT00406029|141268661|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.222|TWO_SIDED|94.0|-0.5|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.0|-0.5|0.222
70891285|NCT00406029|141268661|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.673|TWO_SIDED|95.0|-1.0|1.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.5|-1.0|0.673
70891286|NCT00406029|141268661|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.415|TWO_SIDED|95.0|-0.7|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-0.7|0.415
70891287|NCT00406029|141268661|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.968|TWO_SIDED|95.0|-1.3|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-1.3|0.968
70891288|NCT00406029|141268661|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.543|TWO_SIDED|95.0|-1.0|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-1.0|0.543
70891289|NCT00406029|141268661|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.967|TWO_SIDED|95.0|-1.4|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-1.4|0.967
70891290|NCT00406029|141268661|SUPERIORITY_OR_OTHER||Difference in LS Means|0.6||||0.411|TWO_SIDED|95.0|-0.8|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.0|-0.8|0.411
70891291|NCT00406029|141268661|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.864|TWO_SIDED|95.0|-1.6|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-1.6|0.864
70891292|NCT00406029|141268661|SUPERIORITY_OR_OTHER||Difference in LS Means|0.6||||0.449|TWO_SIDED|95.0|-0.9|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.0|-0.9|0.449
70891293|NCT00406029|141268661|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.411|TWO_SIDED|95.0|-2.0|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-2.0|0.411
70891294|NCT00406029|141268661|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.576|TWO_SIDED|95.0|-1.0|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-1.0|0.576
70891295|NCT00406029|141268661|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.603|TWO_SIDED|95.0|-1.9|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-1.9|0.603
70891296|NCT00406029|141268661|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.842|TWO_SIDED|95.0|-1.4|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-1.4|0.842
70891297|NCT00406029|141268661|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.558|TWO_SIDED|95.0|-1.9|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-1.9|0.558
70891298|NCT00406029|141268661|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.245|TWO_SIDED|95.0|-0.6|2.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.4|-0.6|0.245
70891299|NCT00406029|141268661|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.93|TWO_SIDED|95.0|-1.5|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-1.5|0.930
70891300|NCT00406029|141268661|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.759|TWO_SIDED|95.0|-1.5|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-1.5|0.759
70891301|NCT00406029|141268661|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.374|TWO_SIDED|95.0|-2.4|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-2.4|0.374
70891302|NCT00406029|141268661|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.621|TWO_SIDED|95.0|-1.3|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-1.3|0.621
70891303|NCT00406029|141268661|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.607|TWO_SIDED|95.0|-2.1|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-2.1|0.607
70891304|NCT00406029|141268661|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.907|TWO_SIDED|95.0|-1.4|1.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-1.4|0.907
70891305|NCT00406029|141268661|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.368|TWO_SIDED|95.0|-2.1|0.8|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-2.1|0.368
70891306|NCT00406029|141268661|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.654|TWO_SIDED|95.0|-1.1|1.8|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-1.1|0.654
70891307|NCT00406029|141268661|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.769|TWO_SIDED|95.0|-1.7|1.2|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-1.7|0.769
70891308|NCT00406029|141268662|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.055|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.0|-1.0|0.055
70891309|NCT00406029|141268662|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.071|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.0|-1.0|0.071
70891310|NCT00406029|141268662|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.288|TWO_SIDED|95.0|-0.8|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-0.8|0.288
70891311|NCT00406029|141268662|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.764|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.6|0.764
70891312|NCT00406029|141268662|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.342|TWO_SIDED|94.0|-0.9|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.9|0.342
70891313|NCT00406029|141268662|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.611|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.7|0.611
70891314|NCT00406029|141268662|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.424|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.8|0.424
70891315|NCT00406029|141268662|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.991|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.6|0.991
70891316|NCT00406029|141268662|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.185|TWO_SIDED|95.0|-1.3|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-1.3|0.185
70891317|NCT00406029|141268662|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.597|TWO_SIDED|95.0|-1.0|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-1.0|0.597
70891318|NCT00406029|141268662|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.09|TWO_SIDED|95.0|-1.5|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-1.5|0.090
70891319|NCT00406029|141268662|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.686|TWO_SIDED|95.0|-0.9|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.9|0.686
70891320|NCT00406029|141268662|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.501|TWO_SIDED|95.0|-1.0|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-1.0|0.501
70891321|NCT00406029|141268662|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.764|TWO_SIDED|95.0|-0.6|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-0.6|0.764
70891322|NCT00406029|141268662|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.715|TWO_SIDED|95.0|-0.9|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.9|0.715
70891323|NCT00406029|141268662|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.924|TWO_SIDED|95.0|-0.7|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-0.7|0.924
70891324|NCT00406029|141268662|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.264|TWO_SIDED|95.0|-1.2|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-1.2|0.264
70891325|NCT00406029|141268662|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.976|TWO_SIDED|95.0|-0.7|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.7|0.976
70891326|NCT00406029|141268662|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.626|TWO_SIDED|95.0|-0.9|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.9|0.626
70891327|NCT00406029|141268662|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.925|TWO_SIDED|95.0|-0.8|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.8|0.925
70891328|NCT00406029|141268662|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.849|TWO_SIDED|95.0|-1.0|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-1.0|0.849
70891329|NCT00406029|141268662|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.755|TWO_SIDED|95.0|-0.7|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.7|0.755
70891330|NCT00406029|141268662|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.863|TWO_SIDED|95.0|-0.8|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.8|0.863
70891331|NCT00406029|141268662|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.477|TWO_SIDED|95.0|-0.5|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-0.5|0.477
70891332|NCT00406029|141268662|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.432|TWO_SIDED|95.0|-1.0|0.4|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-1.0|0.432
70891333|NCT00406029|141268662|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.909|TWO_SIDED|95.0|-0.8|0.7|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.8|0.909
70891334|NCT00406029|141268662|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.812|TWO_SIDED|95.0|-0.8|0.7|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.8|0.812
70891335|NCT00406029|141268662|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.54|TWO_SIDED|95.0|-0.5|1.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.5|0.540
70891336|NCT00406029|141268663|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.829|TWO_SIDED|95.0|-0.7|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.7|0.829
70891337|NCT00406029|141268663|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.042|TWO_SIDED|95.0|0.0|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|0.0|0.042
70891338|NCT00406029|141268663|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.204|TWO_SIDED|95.0|-0.3|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-0.3|0.204
70891339|NCT00406029|141268663|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.035|TWO_SIDED|95.0|0.1|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|0.1|0.035
70891340|NCT00406029|141268663|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.696|TWO_SIDED|94.0|-1.2|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-1.2|0.696
70891341|NCT00406029|141268663|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.625|TWO_SIDED|95.0|-0.7|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.7|0.625
70891342|NCT00406029|141268663|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.478|TWO_SIDED|95.0|-0.6|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-0.6|0.478
70891343|NCT00406029|141268663|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.38|TWO_SIDED|95.0|-0.5|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-0.5|0.380
70891344|NCT00406029|141268663|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.925|TWO_SIDED|95.0|-1.2|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-1.2|0.925
70891345|NCT00406029|141268663|SUPERIORITY_OR_OTHER||Difference in LS Means|0.6||||0.285|TWO_SIDED|95.0|-0.5|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-0.5|0.285
70891346|NCT00406029|141268663|SUPERIORITY_OR_OTHER||Difference in LS Means|0.6||||0.296|TWO_SIDED|95.0|-0.5|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-0.5|0.296
70891347|NCT00406029|141268663|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.241|TWO_SIDED|95.0|-0.5|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-0.5|0.241
70891348|NCT00406029|141268663|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.571|TWO_SIDED|95.0|-0.9|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.9|0.571
70891349|NCT00406029|141268663|SUPERIORITY_OR_OTHER||Difference in LS Means|1.3||||0.032|TWO_SIDED|95.0|0.1|2.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.4|0.1|0.032
70891350|NCT00406029|141268663|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.214|TWO_SIDED|95.0|-0.4|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.0|-0.4|0.214
70891351|NCT00406029|141268663|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.051|TWO_SIDED|95.0|0.0|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|0.0|0.051
70891352|NCT00406029|141268663|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.572|TWO_SIDED|95.0|-0.9|1.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.5|-0.9|0.572
70891353|NCT00406029|141268663|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.041|TWO_SIDED|95.0|0.1|2.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.4|0.1|0.041
70891354|NCT00406029|141268663|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.24|TWO_SIDED|95.0|-0.5|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-0.5|0.240
70891355|NCT00406029|141268663|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.047|TWO_SIDED|95.0|0.0|2.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.4|0.0|0.047
70891356|NCT00406029|141268663|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.228|TWO_SIDED|95.0|-0.5|2.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.2|-0.5|0.228
70891357|NCT00406029|141268663|SUPERIORITY_OR_OTHER||Difference in LS Means|1.4||||0.03|TWO_SIDED|95.0|0.1|2.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.6|0.1|0.030
70891358|NCT00406029|141268663|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.059|TWO_SIDED|95.0|0.0|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|0.0|0.059
70891359|NCT00406029|141268663|SUPERIORITY_OR_OTHER||Difference in LS Means|1.5||||0.021|TWO_SIDED|95.0|0.2|2.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.7|0.2|0.021
70891360|NCT00406029|141268663|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.428|TWO_SIDED|95.0|-0.6|1.5|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.5|-0.6|0.428
70891361|NCT00406029|141268663|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.025|TWO_SIDED|95.0|0.2|2.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.3|0.2|0.025
70891362|NCT00406029|141268663|SUPERIORITY_OR_OTHER||Difference in LS Means|1.0||||0.064|TWO_SIDED|95.0|-0.1|2.1|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-0.1|0.064
70891363|NCT00406029|141268663|SUPERIORITY_OR_OTHER||Difference in LS Means|1.1||||0.047|TWO_SIDED|95.0|0.0|2.1|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|0.0|0.047
70891364|NCT00406029|141268664|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.345|TWO_SIDED|95.0|-1.4|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-1.4|0.345
70891365|NCT00406029|141268664|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.468|TWO_SIDED|95.0|-0.6|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-0.6|0.468
70891366|NCT00406029|141268664|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.596|TWO_SIDED|95.0|-0.7|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.7|0.596
70891367|NCT00406029|141268664|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.107|TWO_SIDED|95.0|-0.2|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-0.2|0.107
70891368|NCT00406029|141268664|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.348|TWO_SIDED|94.0|-1.8|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-1.8|0.348
70891369|NCT00406029|141268664|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.938|TWO_SIDED|95.0|-1.1|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-1.1|0.938
70891370|NCT00406029|141268664|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.897|TWO_SIDED|95.0|-1.1|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-1.1|0.897
70891371|NCT00406029|141268664|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.518|TWO_SIDED|95.0|-0.8|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.8|0.518
70891372|NCT00406029|141268664|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.311|TWO_SIDED|95.0|-2.2|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-2.2|0.311
70891373|NCT00406029|141268664|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.597|TWO_SIDED|95.0|-1.0|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-1.0|0.597
70891374|NCT00406029|141268664|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.925|TWO_SIDED|95.0|-1.5|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-1.5|0.925
70891375|NCT00406029|141268664|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.478|TWO_SIDED|95.0|-0.9|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-0.9|0.478
70891376|NCT00406029|141268664|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.995|TWO_SIDED|95.0|-1.5|1.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.5|-1.5|0.995
70891377|NCT00406029|141268664|SUPERIORITY_OR_OTHER||Difference in LS Means|1.3||||0.057|TWO_SIDED|95.0|0.0|2.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.7|0.0|0.057
70891378|NCT00406029|141268664|SUPERIORITY_OR_OTHER||Difference in LS Means|0.6||||0.431|TWO_SIDED|95.0|-0.9|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.0|-0.9|0.431
70891379|NCT00406029|141268664|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.099|TWO_SIDED|95.0|-0.2|2.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.7|-0.2|0.099
70891380|NCT00406029|141268664|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.847|TWO_SIDED|95.0|-1.5|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-1.5|0.847
70891381|NCT00406029|141268664|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.093|TWO_SIDED|95.0|-0.2|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|-0.2|0.093
70891382|NCT00406029|141268664|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.471|TWO_SIDED|95.0|-0.9|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-0.9|0.471
70891383|NCT00406029|141268664|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.102|TWO_SIDED|95.0|-0.2|2.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.6|-0.2|0.102
70891384|NCT00406029|141268664|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.415|TWO_SIDED|95.0|-0.9|2.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.3|-0.9|0.415
70891385|NCT00406029|141268664|SUPERIORITY_OR_OTHER||Difference in LS Means|1.5||||0.051|TWO_SIDED|95.0|0.0|3.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.0|0.0|0.051
70891386|NCT00406029|141268664|SUPERIORITY_OR_OTHER||Difference in LS Means|1.3||||0.103|TWO_SIDED|95.0|-0.3|2.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.8|-0.3|0.103
70891387|NCT00406029|141268664|SUPERIORITY_OR_OTHER||Difference in LS Means|1.7||||0.022|TWO_SIDED|95.0|0.3|3.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.2|0.3|0.022
70891388|NCT00406029|141268664|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.903|TWO_SIDED|95.0|-1.2|1.4|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-1.2|0.903
70891389|NCT00406029|141268664|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.074|TWO_SIDED|95.0|-0.1|2.5|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|-0.1|0.074
70891390|NCT00406029|141268664|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.185|TWO_SIDED|95.0|-0.4|2.2|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.2|-0.4|0.185
70891391|NCT00406029|141268664|SUPERIORITY_OR_OTHER||Difference in LS Means|1.3||||0.054|TWO_SIDED|95.0|0.0|2.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.6|0.0|0.054
70891392|NCT00406029|141268665|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.985|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.5|0.985
70891393|NCT00406029|141268665|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.556|TWO_SIDED|95.0|-0.3|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.3|0.556
70891394|NCT00406029|141268665|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.776|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.4|0.776
70891395|NCT00406029|141268665|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.777|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.4|0.777
70891396|NCT00406029|141268665|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.92|TWO_SIDED|94.0|-0.5|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.5|0.920
70891397|NCT00406029|141268665|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.155|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.1|0.155
70891398|NCT00406029|141268665|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.843|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.5|0.843
70891399|NCT00406029|141268665|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.673|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.4|0.673
70891400|NCT00406029|141268665|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.612|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.7|0.612
70891401|NCT00406029|141268665|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.512|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.4|0.512
70891402|NCT00406029|141268665|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.269|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-0.9|0.269
70891403|NCT00406029|141268665|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.516|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.7|0.516
70891404|NCT00406029|141268665|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.597|TWO_SIDED|95.0|-0.8|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.8|0.597
70891405|NCT00406029|141268665|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.766|TWO_SIDED|95.0|-0.7|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.7|0.766
70891406|NCT00406029|141268665|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.428|TWO_SIDED|95.0|-0.9|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.9|0.428
70891407|NCT00406029|141268665|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.796|TWO_SIDED|95.0|-0.7|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.7|0.796
70891408|NCT00406029|141268665|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.988|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.6|0.988
70891409|NCT00406029|141268665|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.786|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.5|0.786
70891410|NCT00406029|141268665|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.702|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.5|0.702
70891411|NCT00406029|141268665|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.371|TWO_SIDED|95.0|-0.3|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.3|0.371
70891412|NCT00406029|141268665|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.981|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.6|0.981
70891413|NCT00406029|141268665|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.282|TWO_SIDED|95.0|-0.3|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.3|0.282
70891414|NCT00406029|141268665|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.55|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.7|0.550
70891415|NCT00406029|141268665|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.72|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.5|0.720
70891416|NCT00406029|141268665|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.742|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.5|0.742
70891417|NCT00406029|141268665|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.211|TWO_SIDED|95.0|-0.2|0.9|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.2|0.211
70891418|NCT00406029|141268665|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.906|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.6|0.906
70891419|NCT00406029|141268665|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.868|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.5|0.868
70891420|NCT00406029|141268672|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.747|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.6|0.747
70891421|NCT00406029|141268672|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.14|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-0.9|0.140
70891422|NCT00406029|141268672|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.148|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-0.9|0.148
70891423|NCT00406029|141268672|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.005|TWO_SIDED|95.0|-1.2|-0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.2|-1.2|0.005
70891424|NCT00406029|141268672|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.256|TWO_SIDED|94.0|-0.8|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-0.8|0.256
70891425|NCT00406029|141268672|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.343|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.8|0.343
70891426|NCT00406029|141268672|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.102|TWO_SIDED|95.0|-1.0|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-1.0|0.102
70891427|NCT00406029|141268672|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.161|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-0.9|0.161
70891428|NCT00406029|141268672|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.15|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-0.9|0.150
70891429|NCT00406029|141268672|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.175|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-0.9|0.175
70891430|NCT00406029|141268672|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.013|TWO_SIDED|95.0|-1.2|-0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.1|-1.2|0.013
70891431|NCT00406029|141268672|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.12|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-0.9|0.120
70891432|NCT00406029|141268672|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.971|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.6|0.971
70891433|NCT00406029|141268672|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.456|TWO_SIDED|95.0|-0.7|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.7|0.456
70891434|NCT00406029|141268672|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.018|TWO_SIDED|95.0|-1.2|-0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.1|-1.2|0.018
70891435|NCT00406029|141268672|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.175|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-0.9|0.175
70891436|NCT00406029|141268672|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.422|TWO_SIDED|95.0|-0.3|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-0.3|0.422
70891437|NCT00406029|141268672|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.651|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.4|0.651
70891438|NCT00406029|141268672|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.096|TWO_SIDED|95.0|-1.0|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-1.0|0.096
70891439|NCT00406029|141268672|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.86|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.5|0.860
70891440|NCT00406029|141268672|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.511|TWO_SIDED|95.0|-0.8|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.8|0.511
70891441|NCT00406029|141268672|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.286|TWO_SIDED|95.0|-0.9|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.9|0.286
70891442|NCT00406029|141268672|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9||||0.004|TWO_SIDED|95.0|-1.4|-0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.3|-1.4|0.004
70891443|NCT00406029|141268672|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.06|TWO_SIDED|95.0|-1.1|0.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.0|-1.1|0.060
70891444|NCT00406029|141268672|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.345|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.8|0.345
70891445|NCT00406029|141268672|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.439|TWO_SIDED|95.0|-0.7|0.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.7|0.439
70891446|NCT00406029|141268672|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.004|TWO_SIDED|95.0|-1.4|0.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-1.4|0.004
70891447|NCT00406029|141268672|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.04|TWO_SIDED|95.0|-1.1|0.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.0|-1.1|0.040
70891448|NCT00406029|141268673|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.743|TWO_SIDED|95.0|-1.1|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-1.1|0.743
70891449|NCT00406029|141268673|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.225|TWO_SIDED|95.0|-2.2|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-2.2|0.225
70891450|NCT00406029|141268673|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.252|TWO_SIDED|95.0|-2.2|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-2.2|0.252
70891451|NCT00406029|141268673|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9||||0.173|TWO_SIDED|95.0|-2.3|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-2.3|0.173
70891452|NCT00406029|141268673|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.757|TWO_SIDED|94.0|-1.3|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-1.3|0.757
70891453|NCT00406029|141268673|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.581|TWO_SIDED|95.0|-1.1|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-1.1|0.581
70891454|NCT00406029|141268673|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.195|TWO_SIDED|95.0|-2.5|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-2.5|0.195
70891455|NCT00406029|141268673|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.272|TWO_SIDED|95.0|-2.4|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-2.4|0.272
70891456|NCT00406029|141268673|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.758|TWO_SIDED|95.0|-1.7|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-1.7|0.758
70891457|NCT00406029|141268673|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.416|TWO_SIDED|95.0|-2.1|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-2.1|0.416
70891458|NCT00406029|141268673|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.174|TWO_SIDED|95.0|-2.5|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-2.5|0.174
70891459|NCT00406029|141268673|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.547|TWO_SIDED|95.0|-1.1|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.0|-1.1|0.547
70891460|NCT00406029|141268673|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.372|TWO_SIDED|95.0|-0.8|2.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.2|-0.8|0.372
70891461|NCT00406029|141268673|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.942|TWO_SIDED|95.0|-1.4|1.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.5|-1.4|0.942
70891462|NCT00406029|141268673|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.3||||0.082|TWO_SIDED|95.0|-2.8|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-2.8|0.082
70891463|NCT00406029|141268673|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.267|TWO_SIDED|95.0|-2.3|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-2.3|0.267
70891464|NCT00406029|141268673|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.801|TWO_SIDED|95.0|-1.5|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-1.5|0.801
70891465|NCT00406029|141268673|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.753|TWO_SIDED|95.0|-1.9|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-1.9|0.753
70891466|NCT00406029|141268673|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.4||||0.087|TWO_SIDED|95.0|-3.1|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-3.1|0.087
70891467|NCT00406029|141268673|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.796|TWO_SIDED|95.0|-1.9|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-1.9|0.796
70891468|NCT00406029|141268673|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.621|TWO_SIDED|95.0|-1.3|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-1.3|0.621
70891469|NCT00406029|141268673|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.784|TWO_SIDED|95.0|-1.8|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-1.8|0.784
70891470|NCT00406029|141268673|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.9||||0.024|TWO_SIDED|95.0|-3.5|-0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.2|-3.5|0.024
70891471|NCT00406029|141268673|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.963|TWO_SIDED|95.0|-1.6|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-1.6|0.963
70891472|NCT00406029|141268673|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.331|TWO_SIDED|95.0|-0.8|2.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.3|-0.8|0.331
70891473|NCT00406029|141268673|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.898|TWO_SIDED|95.0|-1.4|1.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-1.4|0.898
70891474|NCT00406029|141268673|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5||||0.058|TWO_SIDED|95.0|-3.0|0.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.0|-3.0|0.058
70891475|NCT00406029|141268673|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.832|TWO_SIDED|95.0|-1.3|1.7|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-1.3|0.832
70891476|NCT00406029|141268674|SUPERIORITY_OR_OTHER||Difference in LS Means|1.7||||0.365|TWO_SIDED|95.0|-2.0|5.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.3|-2.0|0.365
70891477|NCT00406029|141268674|SUPERIORITY_OR_OTHER||Difference in LS Means|1.4||||0.476|TWO_SIDED|95.0|-2.4|5.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.1|-2.4|0.476
70891478|NCT00406029|141268674|SUPERIORITY_OR_OTHER||Difference in LS Means|1.8||||0.343|TWO_SIDED|95.0|-2.0|5.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.6|-2.0|0.343
70891479|NCT00406029|141268674|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.1||||0.103|TWO_SIDED|95.0|-6.8|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-6.8|0.103
70891480|NCT00406029|141268674|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.3||||0.224|TWO_SIDED|94.0|-6.0|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-6.0|0.224
70891481|NCT00406029|141268674|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.4||||0.448|TWO_SIDED|95.0|-5.1|2.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.2|-5.1|0.448
70891482|NCT00406029|141268674|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.7||||0.154|TWO_SIDED|95.0|-6.4|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-6.4|0.154
70891483|NCT00406029|141268674|SUPERIORITY_OR_OTHER||Difference in LS Means|-4.8||||0.01|TWO_SIDED|95.0|-8.5|-1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-1.1|-8.5|0.010
70891484|NCT00406029|141268674|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.54|TWO_SIDED|95.0|-2.6|5.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.0|-2.6|0.540
70891485|NCT00406029|141268674|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9||||0.646|TWO_SIDED|95.0|-4.7|2.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.9|-4.7|0.646
70891486|NCT00406029|141268674|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.608|TWO_SIDED|95.0|-4.9|2.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.9|-4.9|0.608
70891487|NCT00406029|141268674|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.9||||0.343|TWO_SIDED|95.0|-6.0|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-6.0|0.343
70891488|NCT00406029|141268674|SUPERIORITY_OR_OTHER||Difference in LS Means|1.7||||0.419|TWO_SIDED|95.0|-2.5|5.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.9|-2.5|0.419
70891489|NCT00406029|141268674|SUPERIORITY_OR_OTHER||Difference in LS Means|1.1||||0.562|TWO_SIDED|95.0|-2.8|5.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.1|-2.8|0.562
70891490|NCT00406029|141268674|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.3||||0.525|TWO_SIDED|95.0|-5.3|2.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.7|-5.3|0.525
70891491|NCT00406029|141268674|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.0||||0.148|TWO_SIDED|95.0|-7.0|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-7.0|0.148
70891492|NCT00406029|141268674|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.3||||0.546|TWO_SIDED|95.0|-5.4|2.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.9|-5.4|0.546
70891493|NCT00406029|141268674|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.7||||0.068|TWO_SIDED|95.0|-7.6|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-7.6|0.068
70891494|NCT00406029|141268674|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.5||||0.208|TWO_SIDED|95.0|-6.5|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-6.5|0.208
70891495|NCT00406029|141268674|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.4||||0.099|TWO_SIDED|95.0|-7.5|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-7.5|0.099
70891496|NCT00406029|141268674|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.731|TWO_SIDED|95.0|-3.6|5.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.1|-3.6|0.731
70891497|NCT00406029|141268674|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.861|TWO_SIDED|95.0|-4.5|3.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.8|-4.5|0.861
70891498|NCT00406029|141268674|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.621|TWO_SIDED|95.0|-5.2|3.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.1|-5.2|0.621
70891499|NCT00406029|141268674|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.2||||0.288|TWO_SIDED|95.0|-6.4|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-6.4|0.288
70891500|NCT00406029|141268674|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.861|TWO_SIDED|95.0|-3.5|4.1|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||4.1|-3.5|0.861
70891501|NCT00406029|141268674|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.954|TWO_SIDED|95.0|-4.0|3.7|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.7|-4.0|0.954
70891502|NCT00406029|141268674|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.6||||0.419|TWO_SIDED|95.0|-5.5|2.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.3|-5.5|0.419
70891503|NCT00406029|141268674|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.2||||0.088|TWO_SIDED|95.0|-6.9|0.5|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-6.9|0.088
70891504|NCT00406029|141268675|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.924|TWO_SIDED|95.0|-3.5|3.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.2|-3.5|0.924
70891505|NCT00406029|141268675|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.84|TWO_SIDED|95.0|-3.8|3.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.1|-3.8|0.840
70891506|NCT00406029|141268675|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9||||0.599|TWO_SIDED|95.0|-4.4|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|-4.4|0.599
70891507|NCT00406029|141268675|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.6||||0.134|TWO_SIDED|95.0|-6.0|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-6.0|0.134
70891508|NCT00406029|141268675|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.846|TWO_SIDED|94.0|-4.1|3.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.3|-4.1|0.846
70891509|NCT00406029|141268675|SUPERIORITY_OR_OTHER||Difference in LS Means|1.3||||0.467|TWO_SIDED|95.0|-2.3|5.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.0|-2.3|0.467
70891510|NCT00406029|141268675|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.2||||0.533|TWO_SIDED|95.0|-4.8|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|-4.8|0.533
70891511|NCT00406029|141268675|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.1||||0.094|TWO_SIDED|95.0|-6.7|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-6.7|0.094
70891512|NCT00406029|141268675|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.994|TWO_SIDED|95.0|-3.7|3.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.7|-3.7|0.994
70891513|NCT00406029|141268675|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.944|TWO_SIDED|95.0|-3.5|3.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.8|-3.5|0.944
70891514|NCT00406029|141268675|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5||||0.424|TWO_SIDED|95.0|-5.1|2.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.2|-5.1|0.424
70891515|NCT00406029|141268675|SUPERIORITY_OR_OTHER||Difference in LS Means|-4.0||||0.042|TWO_SIDED|95.0|-7.8|-0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.2|-7.8|0.042
70891516|NCT00406029|141268675|SUPERIORITY_OR_OTHER||Difference in LS Means|3.7||||0.075|TWO_SIDED|95.0|-0.4|7.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||7.8|-0.4|0.075
70891517|NCT00406029|141268675|SUPERIORITY_OR_OTHER||Difference in LS Means|3.9||||0.052|TWO_SIDED|95.0|0.0|7.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||7.8|0.0|0.052
70891518|NCT00406029|141268675|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.975|TWO_SIDED|95.0|-4.0|3.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.9|-4.0|0.975
70891519|NCT00406029|141268675|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.2||||0.541|TWO_SIDED|95.0|-5.2|2.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.8|-5.2|0.541
70891520|NCT00406029|141268675|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.931|TWO_SIDED|95.0|-4.1|3.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.7|-4.1|0.931
70891521|NCT00406029|141268675|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.618|TWO_SIDED|95.0|-4.7|2.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.8|-4.7|0.618
70891522|NCT00406029|141268675|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.8||||0.341|TWO_SIDED|95.0|-5.6|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-5.6|0.341
70891523|NCT00406029|141268675|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.2||||0.256|TWO_SIDED|95.0|-6.0|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-6.0|0.256
70891524|NCT00406029|141268675|SUPERIORITY_OR_OTHER||Difference in LS Means|1.8||||0.399|TWO_SIDED|95.0|-2.4|6.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||6.0|-2.4|0.399
70891525|NCT00406029|141268675|SUPERIORITY_OR_OTHER||Difference in LS Means|1.4||||0.477|TWO_SIDED|95.0|-2.5|5.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.4|-2.5|0.477
70891526|NCT00406029|141268675|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.8||||0.172|TWO_SIDED|95.0|-6.8|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-6.8|0.172
70891527|NCT00406029|141268675|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.3||||0.254|TWO_SIDED|95.0|-6.2|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-6.2|0.254
70891528|NCT00406029|141268675|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.972|TWO_SIDED|95.0|-3.6|3.8|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.8|-3.6|0.972
70891529|NCT00406029|141268675|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.891|TWO_SIDED|95.0|-3.5|4.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||4.0|-3.5|0.891
70891530|NCT00406029|141268675|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.8||||0.143|TWO_SIDED|95.0|-6.6|1.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-6.6|0.143
70891531|NCT00406029|141268675|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.2||||0.083|TWO_SIDED|95.0|-6.8|0.4|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-6.8|0.083
70891532|NCT00406029|141268676|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.154|TWO_SIDED|95.0|-0.2|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.2|0.154
70891533|NCT00406029|141268676|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.38|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.4|0.380
70891534|NCT00406029|141268676|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.288|TWO_SIDED|95.0|-0.3|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-0.3|0.288
70891535|NCT00406029|141268676|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.355|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.4|0.355
70891536|NCT00406029|141268676|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.831|TWO_SIDED|94.0|-0.8|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.8|0.831
70891537|NCT00406029|141268676|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.198|TWO_SIDED|95.0|-1.2|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-1.2|0.198
70891538|NCT00406029|141268676|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.792|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.8|0.792
70891539|NCT00406029|141268676|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.749|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.8|0.749
70891540|NCT00406029|141268676|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.896|TWO_SIDED|95.0|-0.8|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.8|0.896
70891541|NCT00406029|141268676|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.48|TWO_SIDED|95.0|-0.5|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.5|0.480
70891542|NCT00406029|141268676|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.285|TWO_SIDED|95.0|-0.4|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.4|0.285
70891543|NCT00406029|141268676|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.212|TWO_SIDED|95.0|-0.3|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-0.3|0.212
70891544|NCT00406029|141268676|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.883|TWO_SIDED|95.0|-0.9|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.9|0.883
70891545|NCT00406029|141268676|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.947|TWO_SIDED|95.0|-0.9|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.9|0.947
70891546|NCT00406029|141268676|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.663|TWO_SIDED|95.0|-1.1|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-1.1|0.663
70891547|NCT00406029|141268676|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.157|TWO_SIDED|95.0|-0.3|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.3|0.157
70891548|NCT00406029|141268676|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.283|TWO_SIDED|95.0|-1.4|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-1.4|0.283
70891549|NCT00406029|141268676|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.768|TWO_SIDED|95.0|-1.0|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-1.0|0.768
70891550|NCT00406029|141268676|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.334|TWO_SIDED|95.0|-1.3|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-1.3|0.334
70891551|NCT00406029|141268676|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.465|TWO_SIDED|95.0|-1.2|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-1.2|0.465
70891552|NCT00406029|141268676|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.688|TWO_SIDED|95.0|-1.2|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-1.2|0.688
70891553|NCT00406029|141268676|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.062|TWO_SIDED|95.0|0.0|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|0.0|0.062
70891554|NCT00406029|141268676|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.579|TWO_SIDED|95.0|-1.2|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-1.2|0.579
70891555|NCT00406029|141268676|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.644|TWO_SIDED|95.0|-0.7|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.7|0.644
70891556|NCT00406029|141268676|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.825|TWO_SIDED|95.0|-0.8|1.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.8|0.825
70891557|NCT00406029|141268676|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.233|TWO_SIDED|95.0|-0.3|1.4|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-0.3|0.233
70891558|NCT00406029|141268676|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.853|TWO_SIDED|95.0|-0.8|1.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.8|0.853
70891559|NCT00406029|141268676|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.592|TWO_SIDED|95.0|-0.6|1.1|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-0.6|0.592
70891560|NCT02162810|141268677|OTHER||||||<|0.62|||||||Fisher Exact|||Due to the number of 0 cell counts, it is not possible to do individual statistics for each complication, so we looked at the incidence of complications overall between the two arms.||||<.62
70891561|NCT02162810|141268678|OTHER||||||<|0.61|||||||Fisher Exact|||||||<0.61
70891562|NCT02162810|141268679|OTHER||||||<|0.87|||||||Fisher Exact|||Improvement category: Chordee with Degloving||||<.87
70891563|NCT02162810|141268679|OTHER||||||<|0.64|||||||Fisher Exact|||Improvement category: Ventral Chordee||||<.64
70891564|NCT02162810|141268679|OTHER||||||<|0.85|||||||Fisher Exact|||Improvement category: Chordee with Plication||||<.85
70891565|NCT02223390|141268685|SUPERIORITY|A sample size of 60 was chosen as adequate to examine the feasibility and acceptability of a pilot randomized controlled trial (RCT) with two conditions.||||||0.08||||||A priori threshold for statistical significance was p\<.05. The p-value presented corresponds to the time by condition interaction parameter.|Mixed Models Analysis|To assess changes in PTSD symptoms over time by intervention condition, linear mixed models were fit using the PROC MIXED procedure in SAS.||Statistical analyses reported below is for PCL - Total at 3 months.||||0.08
70891566|NCT02223390|141268686|SUPERIORITY|A sample size of 60 was chosen as adequate to examine the feasibility and acceptability of a pilot RCT with two conditions.||||||0.05||||||A priori threshold was defined as p\<0.05.|Chi-squared|||||||0.05
70891567|NCT01255358|141268749|OTHER|Changes from baseline (V1) at V2, V4 and V7 were analyzed with a RMANOVA design with age and ICARS at baseline as covariates. A Wilcoxon non-parametric test between visits was performed when the overall analysis was significant in order to help determine timing of effects|Mean Difference (Final Values)|-4.0|STANDARD_DEVIATION|7.5||0.02|TWO_SIDED|95.0|-7.1|-0.9|||Wilcoxon (Mann-Whitney)|||The primary analysis on ICARS Total score has been conducted on the ITT Population employing carry-forward and carry-backward procedures for missing data imputation, in order to evaluate all enrolled patients.||-0.9|-7.1|0.02
70891568|NCT01255358|141268750|OTHER|Changes from baseline (V1) at V2, V4 and V7 were analyzed with a RMANOVA design with age and ICARS at baseline as covariates. A Wilcoxon non-parametric test between visits was performed when the overall analysis was significant in order to help determine timing of effects|Mean Difference (Final Values)|-5.2|STANDARD_DEVIATION|7.0||0.0031|TWO_SIDED|95.0|-8.4|-2.0|||Wilcoxon (Mann-Whitney)|||Overall analysis on the PP Population||-2|-8.4|0.0031
70891569|NCT01255358|141268755|OTHER|VABS Total score and subscales have been analyzed with a RMANOVA design, using age as covariate (dichotomized as Low- or High-, using median age as threshold).|Median Difference (Final Values)|1.3|STANDARD_DEVIATION|1.2|<|0.0001|TWO_SIDED|95.0|0.8|1.8|||Wilcoxon (Mann-Whitney)|||VABS total score at V7||1.8|0.8|<0.0001
70891570|NCT01255358|141268756|OTHER||Mean Difference (Final Values)|1.5|STANDARD_DEVIATION|1.1|<|0.0001|TWO_SIDED|95.0|1.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|1|<0.0001
70891571|NCT00022516|141268770|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.14|TWO_SIDED|95.0|0.6|1.06|||Log Rank|||||1.06|0.6|0.14
70891572|NCT00022516|141268771|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.357|TWO_SIDED|95.0|0.65|1.17|||Log Rank|||||1.17|0.65|0.3570
70891573|NCT00022516|141268772|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.3178|TWO_SIDED|95.0|0.62|1.17|||Log Rank|||||1.17|0.62|0.3178
70891574|NCT00022516|141268773|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.06|TWO_SIDED|95.0|0.6|1.01|||Log Rank|||||1.01|0.6|0.06
70891575|NCT04433767|141268818|OTHER||Slope|-1.22|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED||||||Mixed Models Analysis|Adjusted for age and gender.||||||< 0.001
70891576|NCT04433767|141268820|OTHER||Intercept|0.18|STANDARD_ERROR_OF_MEAN|0.07||0.0127|TWO_SIDED|95.0|0.04|0.32|||Regression, Linear|Adjusted for age, sex, education, and baseline task performance.||||0.32|0.04|0.0127
70891577|NCT04433767|141268821|OTHER||Intercept|0.34|STANDARD_ERROR_OF_MEAN|0.08||0.0005|TWO_SIDED|95.0|0.17|0.51|||Regression, Linear|Adjusted for age, sex, education, and baseline task performance.||||0.51|0.17|0.0005
70891578|NCT04433767|141268822|OTHER||Intercept|0.19|STANDARD_ERROR_OF_MEAN|0.11||0.1027|TWO_SIDED|95.0|-0.04|0.42|||Regression, Linear|Adjusted for age, sex, education, and baseline task performance.||||0.42|-0.04|0.1027
70891579|NCT04433767|141268823|OTHER||Intercept|0.09|STANDARD_ERROR_OF_MEAN|0.13||0.4846|TWO_SIDED|95.0|-0.18|0.37|||Regression, Linear|Adjusted for age, sex, education, and baseline task performance.||||0.37|-0.18|0.4846
70891580|NCT04433767|141268824|OTHER||Intercept|9.04|STANDARD_ERROR_OF_MEAN|25.77||0.729|TWO_SIDED|95.0|-44.28|62.36|||Regression, Linear|Adjusted for age, sex, education, and baseline task performance.||||62.36|-44.28|0.7290
70891581|NCT04433767|141268825|OTHER||Intercept|-0.25|STANDARD_ERROR_OF_MEAN|2.43||0.9196|TWO_SIDED|95.0|-5.28|4.78|||Regression, Linear|Adjusted for age, sex, education, and baseline task performance.||||4.78|-5.28|0.9196
70891582|NCT04433767|141268826|OTHER||Slope|0.17|STANDARD_ERROR_OF_MEAN|0.08||0.033|TWO_SIDED|95.0|0.01|0.33|||Mixed Models Analysis|Adjusted for age and gender.||||0.33|0.01|0.033
70891583|NCT04433767|141268827|OTHER||Slope|0.18|STANDARD_ERROR_OF_MEAN|0.09||0.041|TWO_SIDED|95.0|0.01|0.35|||Mixed Models Analysis|Adjusted for age and gender.||||0.35|0.01|0.041
70891584|NCT04433767|141268828|OTHER||Slope|-11.13|STANDARD_ERROR_OF_MEAN|3.36||0.001|TWO_SIDED|95.0|-17.81|-4.45|||Mixed Models Analysis|Adjusted for age and gender.||||-4.45|-17.81|0.001
70891585|NCT04433767|141268829|OTHER||Slope|-12.64|STANDARD_ERROR_OF_MEAN|3.68||0.001|TWO_SIDED|95.0|-19.94|-5.33|||Mixed Models Analysis|Adjusted for age and gender.||||-5.33|-19.94|0.001
70891586|NCT04433767|141268830|OTHER||Slope|-0.74|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.15|-0.32|||Mixed Models Analysis|||||-0.32|-1.15|<0.001
70891587|NCT04433767|141268831|OTHER||Slope|-0.63|STANDARD_ERROR_OF_MEAN|0.14||0.001|TWO_SIDED|95.0|-0.92|-0.34|||Mixed Models Analysis|Adjusted for age and gender.||||-0.34|-0.92|0.001
70891588|NCT04433767|141268832|OTHER||Slope|-0.41|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.65|-0.18|||Mixed Models Analysis|Adjusted for age and gender.||||-0.18|-0.65|<0.001
70891589|NCT04433767|141268833|OTHER||Slope|-0.47|STANDARD_ERROR_OF_MEAN|0.35||0.183|TWO_SIDED|95.0|-1.17|0.23|||Mixed Models Analysis|Adjusted for age and gender.||||0.23|-1.17|0.183
70891590|NCT04433767|141268834|OTHER||Slope|-0.3|STANDARD_ERROR_OF_MEAN|0.22||0.17|TWO_SIDED|95.0|-0.74|0.13|||Mixed Models Analysis|Analyses adjusted for age and gender.||||0.13|-0.74|0.170
70891591|NCT04433767|141268835|OTHER||Slope|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.051|TWO_SIDED|95.0|0.0|0.8|||Mixed Models Analysis|Analyses adjusted for age and gender.||||0.80|0.00|0.051
70891592|NCT04433767|141268836|OTHER||Slope|-0.22|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.33|-0.11|||Mixed Models Analysis|Analyses adjusted for age and gender.||||-0.11|-0.33|<0.001
70891593|NCT04433767|141268837|OTHER||Slope|0.43|STANDARD_ERROR_OF_MEAN|0.13||0.002|TWO_SIDED|95.0|0.17|0.69|||Mixed Models Analysis|Analyses adjusted for age and gender.||||0.69|0.17|0.002
70891594|NCT04433767|141268838|OTHER||Slope|0.52|STANDARD_ERROR_OF_MEAN|0.14||0.002|TWO_SIDED|95.0|0.21|0.83|||Mixed Models Analysis|Analyses adjusted for age and gender.||||0.83|0.21|0.002
70891595|NCT04433767|141268839|OTHER||Slope|0.09|STANDARD_ERROR_OF_MEAN|0.55||0.876|TWO_SIDED|95.0|-1.05|1.23|||Mixed Models Analysis|Analyses adjusted for age and gender.||||1.23|-1.05|0.876
70891596|NCT00298233|141268840|SUPERIORITY_OR_OTHER|||||||0.42||||||Significance assessed at the 5% level for a two-sided comparison|conditional univariate logistic regressi|analysis stratified by study site||Based on previous studies, assumption was made that 30% of children and 55% of adults treated with standard dose oseltamivir would test negative for virus on day five. This would require a sample size of 242 patients to show a 20% absolute improvement in cessation of viral shedding with 85% power and a two sided α of 0.05. To allow for study withdrawals, the target sample size was set at 300 patients.||||0.42
70891597|NCT00298233|141268841|SUPERIORITY_OR_OTHER|||||||0.54||||||Significance assessed at the 5% level for a two-sided comparison|Mantel Haenszel|||||||0.54
70891598|NCT00298233|141268842|SUPERIORITY_OR_OTHER|||||||0.54||||||Significance assessed at the 5% level for a two-sided comparison|Mantel Haenszel|Mantel-Haenszel chi-square stratified by study site||||||0.54
70891599|NCT00298233|141268843|SUPERIORITY_OR_OTHER|||||||0.48||||||Significance assessed at the 5% level for a two-sided comparison|Kruskal-Wallis|||||||0.48
70891600|NCT00298233|141268844|SUPERIORITY_OR_OTHER|||||||0.66||||||Significance assessed at the 5% level for a two-sided comparison|Kruskal-Wallis|||||||0.66
70891601|NCT00298233|141268845|SUPERIORITY_OR_OTHER|||||||0.58||||||Significance assessed at the 5% level for a two-sided comparison|Kruskal-Wallis|||||||0.58
70891602|NCT00439777|141268846|NON_INFERIORITY_OR_EQUIVALENCE|Assuming equal efficacy, a total of 88 events will give a power of 90% to demonstrate that rivaroxaban is at least as effective as the comparator, considering a relative non-inferiority upper CI margin for the hazard ratio of 2.0 (two-sided alpha=0.05). The mean overall incidence for the primary efficacy outcome of 3% was expected and therefore 1465 patients per group would be needed. This number was to be adjusted based on the observed overall incidence of symptomatic recurrent VTE.|Hazard Ratio (HR)|1.12|STANDARD_ERROR_OF_MEAN|0.2067||0.0026|TWO_SIDED|95.0|0.75|1.68|||Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline|The standard error of the log hazard ratio was estimated.|The rivaroxaban to comparator hazard ratio was computed with a 95% CI (confidence interval) (two-sided testing). Based on this model, rivaroxaban would be considered at least as effective as the comparator if the upper limit of the CI was less than 2.0.||1.68|0.75|0.0026
70891603|NCT00439777|141268847|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16|STANDARD_ERROR_OF_MEAN|0.15||0.33|TWO_SIDED|95.0|0.86|1.56||Nominal p-value|Regression, Cox||The standard error of the log hazard ratio was estimated.|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.||1.56|0.86|0.33
70891604|NCT00439777|141268848|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85|STANDARD_ERROR_OF_MEAN|0.1499||0.275|TWO_SIDED|95.0|0.63|1.14||Nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline|The standard error of the log hazard ratio was estimated.|||1.14|0.63|0.275
70891605|NCT00439777|141268849|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16|STANDARD_ERROR_OF_MEAN|0.257||0.55|TWO_SIDED|95.0|0.7|1.93||nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.|||1.93|0.70|0.55
70891606|NCT00439777|141268850|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|STANDARD_ERROR_OF_MEAN|0.3289||0.85|TWO_SIDED|95.0|0.49|1.79||Nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.|||1.79|0.49|0.85
70891607|NCT00439777|141268851|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|STANDARD_ERROR_OF_MEAN|0.08756||0.23|TWO_SIDED|95.0|0.76|1.07||If the primary efficacy analysis shows that rivaroxaban is non-inferior to the comparator, the principal safety outcome was to be compared between treatment groups to maintain the overall type I error of 0.05 (2-sided) (a closed testing procedure).|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.|||1.07|0.76|0.23
70891608|NCT03855189|141268870|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
70891609|NCT03855189|141268870|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from ANOVA.||||<0.01
70891610|NCT03855189|141268870|OTHER|||||||0.06|||||||ANOVA|||Pairwise treatment comparison based on t-test from ANOVA.||||0.06
70891611|NCT03855189|141268871|OTHER|||||||0.04|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.04
70891612|NCT03855189|141268871|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
70891613|NCT03855189|141268871|OTHER|||||||0.5|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.50
70891614|NCT03855189|141268874|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
70891615|NCT03855189|141268874|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
70891616|NCT03855189|141268874|OTHER|||||||0.11|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.11
70891617|NCT03855189|141268875|OTHER|||||||0.05|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.05
70891618|NCT03855189|141268875|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
70891619|NCT03855189|141268875|OTHER|||||||0.13|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.13
70891620|NCT03855189|141268876|OTHER|||||||0.06|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.06
70891621|NCT03855189|141268876|OTHER|||||||0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.03
70891622|NCT03855189|141268876|OTHER|||||||0.81|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.81
70891623|NCT03855189|141268877|OTHER|||||||0.02|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.02
70891624|NCT03855189|141268877|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
70891625|NCT03855189|141268877|OTHER|||||||0.17|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.17
70891626|NCT03855189|141268878|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
70891627|NCT03855189|141268878|OTHER|||||||0.02|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.02
70891628|NCT03855189|141268878|OTHER|||||||0.39|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.39
70891629|NCT03855189|141268879|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
70891630|NCT03855189|141268879|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
70891631|NCT03855189|141268879|OTHER|||||||0.6|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.60
70891632|NCT03855189|141268880|OTHER|||||||0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.03
70891633|NCT03855189|141268880|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
70891634|NCT03855189|141268880|OTHER|||||||0.54|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.54
70891635|NCT03855189|141268881|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
70891636|NCT03855189|141268881|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
70891637|NCT03855189|141268881|OTHER|||||||0.71|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.71
70891638|NCT03855189|141268882|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
70891639|NCT03855189|141268882|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
70891640|NCT03855189|141268882|OTHER|||||||0.77|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.77
70891641|NCT03855189|141268883|OTHER|||||||0.11|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.11
70891642|NCT03855189|141268883|OTHER|||||||0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.03
70891643|NCT03855189|141268883|OTHER|||||||0.6|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.60
70891644|NCT03855189|141268884|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
70891645|NCT03855189|141268884|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
70891646|NCT03855189|141268884|OTHER|||||||0.59|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.59
70891647|NCT03855189|141268885|OTHER|||||||0.07|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.07
70891648|NCT03855189|141268885|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
70891649|NCT03855189|141268885|OTHER|||||||0.43|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.43
70891650|NCT03855189|141268886|OTHER|||||||0.09|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.09
70891651|NCT03855189|141268886|OTHER|||||||0.08|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.08
70891652|NCT03855189|141268886|OTHER|||||||0.96|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.96
70891653|NCT03855189|141268887|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
70891654|NCT03855189|141268887|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
70891655|NCT03855189|141268887|OTHER|||||||0.64|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.64
70891656|NCT03855189|141268888|OTHER|||||||0.25|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.25
70891657|NCT03855189|141268888|OTHER|||||||0.02|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.02
70891658|NCT03855189|141268888|OTHER|||||||0.26|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.26
70891659|NCT03855189|141268889|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
70891660|NCT03855189|141268889|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
70891661|NCT03855189|141268889|OTHER|||||||0.09|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.09
70891662|NCT03855189|141268890|OTHER|||||||0.05|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.05
70891663|NCT03855189|141268890|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
70891664|NCT03855189|141268890|OTHER|||||||0.07|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.07
70891665|NCT03855189|141268891|OTHER|||||||0.04|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.04
70891666|NCT03855189|141268891|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
70891667|NCT03855189|141268891|OTHER|||||||0.53|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.53
70891668|NCT03855189|141268892|OTHER|||||||0.02|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.02
70891669|NCT03855189|141268892|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
70891670|NCT03855189|141268892|OTHER|||||||0.02|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.02
70891671|NCT03855189|141268893|OTHER|||||||0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.03
70891672|NCT03855189|141268893|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
70891673|NCT03855189|141268893|OTHER|||||||0.34|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.34
70891674|NCT03855189|141268894|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
70891675|NCT03855189|141268894|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
70891676|NCT03855189|141268894|OTHER|||||||0.04|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.04
70891677|NCT03855189|141268895|OTHER|||||||0.06|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.06
70891678|NCT03855189|141268895|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
70891679|NCT03855189|141268895|OTHER|||||||0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.03
70891680|NCT03855189|141268896|OTHER|||||||0.13|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.13
70891681|NCT03855189|141268896|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
70891682|NCT03855189|141268896|OTHER|||||||0.07|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.07
70891683|NCT03855189|141268897|OTHER|||||||0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.03
70891684|NCT03855189|141268897|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
70891685|NCT03855189|141268897|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
70891686|NCT04307186|141268920|OTHER|"McNemar test was used for the exploratory analysis of difference between the percentage of participants greatly prefer/prefer gadoquatrane and greatly prefer/prefer gadobutrol."|||||<|0.0001||||||P-Value was calculated. p \< 0.05 indicates a difference between the two reads; p \> 0.05 indicates the observed data do not contradict equality.|McNemar|||Reader 1||||<0.0001
70891687|NCT04307186|141268920|OTHER|"McNemar test was used for the exploratory analysis of difference between the percentage of participants greatly prefer/prefer gadoquatrane and greatly prefer/prefer gadobutrol."||||||0.5775||||||P-Value was calculated. p \< 0.05 indicates a difference between the two reads; p \> 0.05 indicates the observed data do not contradict equality.|McNemar|||Reader 2||||0.5775
70891688|NCT04307186|141268920|OTHER|"McNemar test was used for the exploratory analysis of difference between the percentage of participants greatly prefer/prefer gadoquatrane and greatly prefer/prefer gadobutrol."||||||0.3173||||||P-Value was calculated. p \< 0.05 indicates a difference between the two reads; p \> 0.05 indicates the observed data do not contradict equality.|McNemar|||Reader 3||||0.3173
70891689|NCT04307186|141268921|NON_INFERIORITY|The non-inferiority of gadoquatrane versus gadobutrol was evaluated using CIs based on the t-distribution. A non-inferiority margin of 1 was used, i.e. meaning that a 95% two-sided CI for the mean difference gadoquatrane minus gadobutrol score must exclude the value -1.|Mean Difference (Final Values)|-0.05|||<|0.0001|TWO_SIDED|95.0|-0.24|0.13||P-Value was calculated. Non-inferiority was achieved with a one-sided p-value lower than 0.025.|t-test, 1 sided|||Average reader||0.13|-0.24|<0.0001
70891690|NCT04307186|141268922|OTHER|95% two-sided CIs based on a t-distribution for the difference of combined pre- and post-contrast minus pre-contrast scores.|Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|1.06|1.34|||||Descriptive comparison of the result following gadobutrol with the result following gadoquatrane.|Average Reader||1.34|1.06|
70891691|NCT04307186|141268922|OTHER|95% two-sided CIs based on a t-distribution for the difference of combined pre- and post-contrast minus pre-contrast scores.|Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|0.94|1.25|||||Descriptive comparison of the result following gadobutrol with the result following gadoquatrane.|Average Reader||1.25|0.94|
70891692|NCT04307186|141268923|OTHER|95% two-sided CIs based on a t-distribution for the difference of combined pre- and post-contrast minus pre-contrast scores.|Mean Difference (Final Values)|2.07|||||TWO_SIDED|95.0|1.87|2.28|||||Descriptive comparison of the result following gadobutrol with the result following gadoquatrane.|Average Reader||2.28|1.87|
70891693|NCT04307186|141268923|OTHER|95% two-sided CIs based on a t-distribution for the difference of combined pre- and post-contrast minus pre-contrast scores.|Mean Difference (Final Values)|2.06|||||TWO_SIDED|95.0|1.86|2.25|||||Descriptive comparison of the result following gadobutrol with the result following gadoquatrane.|Average Reader||2.25|1.86|
70891694|NCT04307186|141268924|OTHER|95% two-sided CIs based on a t-distribution for the difference of combined pre- and post-contrast minus pre-contrast scores.|Mean Difference (Final Values)|1.27|||||TWO_SIDED|95.0|1.11|1.43|||||Descriptive comparison of the result following gadobutrol with the result following gadoquatrane.|Average Reader||1.43|1.11|
70891695|NCT04307186|141268924|OTHER|95% two-sided CIs based on a t-distribution for the difference of combined pre- and post-contrast minus pre-contrast scores.|Mean Difference (Final Values)|1.19|||||TWO_SIDED|95.0|1.05|1.32|||||Descriptive comparison of the result following gadobutrol with the result following gadoquatrane.|Average Reader||1.32|1.05|
70891696|NCT01175226|141268926|SUPERIORITY|||||||0.02|||||||ANCOVA|||||||0.020
70891697|NCT02854540|141268927|OTHER||Mean difference (percent)|59.0|STANDARD_DEVIATION|16.0|||TWO_SIDED|||||||||||||
70891698|NCT03238001|141268930|NON_INFERIORITY|In order to show non-inferiority, a lower 90% confidence limit (CL) for the difference in kappa scores would need to be greater than or equal to -0.20. The 90% confidence interval was calculated based on 5000 bootstrapped differences in kappa scores.|Lower 90% CL for difference in Kappas|-0.12|||||TWO_SIDED|90.0|-0.12|0.05|||||90% CI for Kappa of DCTclock/MoCA - Kappa of MMSE/MoCA (estimated with bootstrap method using 5000 bootstraps).|A two-one-sided tests approach was taken, where, prior to analysis, it was determined that a delta (equivalence margin) of 0.20 would be considered a significant difference between the DCTclock/MoCA kappa and the MMSE/MoCA kappa. The reasoning behind this determination can be found in the study's statistical analysis plan.||0.05|-0.12|
70891699|NCT02207829|141268958|NON_INFERIORITY_OR_EQUIVALENCE|Alternate hypothesis: the difference between the trt means (umeclidinium minus tiotropium) would be \> -50 milliliters (mL). If the lower CI (2.5% 1-sided significance level) of the statistical test should fall above -50 mL, then umeclidinium may be deemed statistically non-inferior to tiotropium. If the lower CI (2.5% 1-sided significance) of the statistical testing exceeded 0 then, umeclidinium may be deemed statistically superior to tiotropium.|Mean Difference (Final Values)|0.059|||<|0.001|TWO_SIDED|95.0|0.029|0.088|||Mixed Models Analysis|||||0.088|0.029|<0.001
70891700|NCT02897141|141268983|SUPERIORITY||Mean Difference (Final Values)|-0.541|STANDARD_ERROR_OF_MEAN|0.156||0.001|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Anxiety||||0.001
70891701|NCT02897141|141268983|SUPERIORITY||Mean Difference (Final Values)|-0.149|STANDARD_ERROR_OF_MEAN|0.161||0.356|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count; a=0.05|Mixed Models Analysis|||Cough or Shortness of Breath||||0.356
70891702|NCT02897141|141268983|SUPERIORITY||Mean Difference (Final Values)|-0.533|STANDARD_ERROR_OF_MEAN|0.163||0.001|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Depression||||0.001
70891703|NCT02897141|141268983|SUPERIORITY||Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.141||0.962|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Diarrhea||||0.962
70891704|NCT02897141|141268983|SUPERIORITY||Mean Difference (Final Values)|-0.073|STANDARD_ERROR_OF_MEAN|0.162||0.651|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Difficulty falling or staying asleep||||0.651
70891705|NCT02897141|141268983|SUPERIORITY|Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mean Difference (Final Values)|-0.174|STANDARD_ERROR_OF_MEAN|0.145||0.23|TWO_SIDED||||||Mixed Models Analysis|||Difficulty remembering||||0.230
70891706|NCT02897141|141268983|SUPERIORITY||Mean Difference (Final Values)|-0.138|STANDARD_ERROR_OF_MEAN|0.126||0.275|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Dizziness||||0.275
70891707|NCT02897141|141268983|SUPERIORITY||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.175||0.987|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Fatigue||||0.987
70891708|NCT02897141|141268983|SUPERIORITY||Mean Difference (Net)|-0.275|STANDARD_ERROR_OF_MEAN|0.132||0.037|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Fever, chills, sweats||||0.037
70891709|NCT02897141|141268983|SUPERIORITY||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.101||0.534|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Nausea or vomiting||||0.534
70891710|NCT02897141|141268983|SUPERIORITY||Mean Difference (Final Values)|-0.485|STANDARD_ERROR_OF_MEAN|0.157||0.002|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Neuropathy||||0.002
70891711|NCT02897141|141268983|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.139||0.349|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Skin problems||||0.349
70891712|NCT02897141|141268983|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.107||0.02|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Weight loss or wasting||||0.020
70891713|NCT02897141|141268984|SUPERIORITY|\[Not specified\]|Mean Difference (Final Values)|-3.06|STANDARD_ERROR_OF_MEAN|7.27||0.001|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|\[Not specified\]|\[Not specified\]|Physical functioning scale||||0.001
70891714|NCT02897141|141268984|SUPERIORITY|\[Not specified\]|Median Difference (Final Values)|7.47|STANDARD_ERROR_OF_MEAN|10.02||0.458|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|\[Not specified\]|\[Not specified\]|Role limitations due to physical health scale||||0.458
70891715|NCT02897141|141268984|SUPERIORITY|\[Not specified\]|Mean Difference (Final Values)|3.5|STANDARD_ERROR_OF_MEAN|9.91||0.725|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|\[Not specified\]|\[Not specified\]|Role limitations due to emotional problems scale||||0.725
70891716|NCT02897141|141268984|SUPERIORITY|\[Not specified\]|Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|4.09||0.807|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|\[Not specified\]|\[Not specified\]|Energy/fatigue scale|\[Not specified\]|||0.807
70891717|NCT02897141|141268984|SUPERIORITY||Mean Difference (Final Values)|1.48|STANDARD_ERROR_OF_MEAN|3.73||0.693|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Emotional well-being scale||||0.693
70891718|NCT02897141|141268984|SUPERIORITY||Mean Difference (Final Values)|-8.93|STANDARD_ERROR_OF_MEAN|5.8||0.128|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Social functioning scale||||0.128
70891719|NCT02897141|141268984|SUPERIORITY||Mean Difference (Final Values)|-14.33|STANDARD_ERROR_OF_MEAN|5.18||0.007|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Pain scale||||0.007
70891720|NCT02897141|141268984|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|3.93||0.96|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||General health scale||||0.960
70891721|NCT02897141|141268984|SUPERIORITY||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|4.47||0.836|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Physical health summary scale||||0.836
70891722|NCT02897141|141268984|SUPERIORITY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|3.6||0.822|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Mental health summary scale||||0.822
70891723|NCT02897141|141268985|SUPERIORITY||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|1.25||0.529|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Physical Function||||0.529
70891724|NCT02897141|141268985|SUPERIORITY||Mean Difference (Final Values)|1.71|STANDARD_ERROR_OF_MEAN|1.68||0.312|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Anxiety||||0.312
70891725|NCT02897141|141268985|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|1.81||0.841|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Depression||||0.841
70891726|NCT02897141|141268985|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|2.07||0.848|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Fatigue||||0.848
70891727|NCT02897141|141268985|SUPERIORITY||Mean Difference (Final Values)|2.58|STANDARD_ERROR_OF_MEAN|2.03||0.208|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Sleep Disturbance||||0.208
70891728|NCT02897141|141268985|SUPERIORITY||Mean Difference (Final Values)|0.72|STANDARD_ERROR_OF_MEAN|2.29||0.754|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Satisfaction with participation in social roles||||0.754
70891729|NCT02897141|141268985|SUPERIORITY||Mean Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|1.66||0.454|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Pain interference||||0.454
70891730|NCT02897141|141268986|SUPERIORITY||Mean Difference (Final Values)|-2.52|STANDARD_ERROR_OF_MEAN|2.19||0.252|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||||||0.252
70891731|NCT02897141|141268987|SUPERIORITY||Mean Difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|0.62||0.017|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||CASE adherence index||||0.017
70891732|NCT02897141|141268987|SUPERIORITY||Mean Difference (Final Values)|-4.88|STANDARD_ERROR_OF_MEAN|5.06||0.338|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Visual analogue scale||||0.338
70891733|NCT02897141|141268988|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.23||0.743|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Overall||||0.743
70891734|NCT02897141|141268988|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.2||0.166|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Quality of life||||0.166
70891735|NCT02897141|141268988|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.26||0.899|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Perceived usefulness||||0.899
70891736|NCT02897141|141268988|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.26||0.803|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Perceived ease of use||||0.803
70891737|NCT02897141|141268988|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.48|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||User Control||||0.480
70891738|NCT05204134|141269000|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
70891739|NCT05204134|141269001|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
70891740|NCT05204134|141269002|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
70891741|NCT05204134|141269003|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
70891742|NCT05204134|141269004|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.26
70891743|NCT05204134|141269005|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
70891744|NCT05204134|141269006|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70891745|NCT05204134|141269007|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70891746|NCT05204134|141269008|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70891747|NCT05204134|141269009|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison between 2 week run-in and 13 weeks Control-IQ use with adaptation.||||<0.001
70891748|NCT05204134|141269010|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70891749|NCT05204134|141269011|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70891750|NCT05204134|141269012|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70891751|NCT05204134|141269013|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70891752|NCT05204134|141269014|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70891753|NCT05204134|141269015|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70891754|NCT05204134|141269016|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70891755|NCT05204134|141269017|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70891756|NCT05204134|141269018|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70891757|NCT05204134|141269019|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
70891758|NCT05204134|141269020|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
70891759|NCT05204134|141269021|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
70891760|NCT01802411|141269034|SUPERIORITY||LSMD|13.1||||0.5598|TWO_SIDED|95.0|-31.0|57.0|||ANCOVA|||||57|-31|0.5598
70891761|NCT02670629|141269039|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED||||||Chi-squared|||||||0.003
70891762|NCT03285477|141269042|SUPERIORITY||||||<|0.0001||||||P-value threshold for statistical significance was 0.5%|Cochran-Mantel-Haenszel|||Statistical significance in the study for Day 57 complete clearance rate was analyzed using a Cochran-Mantel-Haenszel model controlling for treatment location (face or scalp) and treatment group (Placebo versus KX2-391 Ointment 1%).||||<0.0001
70891763|NCT03285477|141269043|SUPERIORITY||||||<|0.0001||||||P-value threshold for statistical significance was 0.5%|Cochran-Mantel-Haenszel|||Statistical significance in the study for Day 57 partial clearance rate was analyzed using a Cochran-Mantel-Haenszel model controlling for treatment location (face or scalp) and treatment group (Placebo versus KX2-391 Ointment 1%).||||<0.0001
70891764|NCT01968434|141269084|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|||The sample size was calculated to detect a 0.75 point difference between any two treatment groups with a 90% power and p\<0.05. Such sample size was 60 subject which was elevated ot 75 subjects per group to account for drop outs. For comparison of cough evaluation before and after treatment a paired Student t test was used.||||<0.01
70891765|NCT01968434|141269085|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
70891766|NCT01968434|141269086|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
70891767|NCT02091167|141269094|OTHER|||||||0.05|||||||ANOVA|||We powered for a medium effect size based on our previous study with effect size (partial ղ2) of 0.10384 for the main within-subject factor in the two-way ANOVA with repeated measures. With a power of 80%, and a two-sided probability of a type I error of 5%, the resulting minimum sample size was 30 participants. To account for waiving or dropouts we increased the estimated sample size to approximately 10%, resulting in 33 subjects in total (approximately 16 to 17 subjects in each group).|"Most of data (age, patterns of crack-cocaine use, 5-items OCCS) were normally distributed according to the D'Agostino \& Pearson normality test, thus they were analyzed by parametric tests. Between-group (sham- and real tDCS) comparisons were conducted by unpaired Student´s t-tests. For all other non-parametric data (gender, schooling, employment, marital state and tobacco use), Chi-square or Fisher tests were used to compare sham and real tDCS groups.~Besides the two-way ANOVA with repeated measures followed by Bonferroni-corrected t-tests, linear regression analyses were done over craving scores obtained along the 4-week treatment (five time-points measurements) for both groups. Additional comparisons between initial and final OCDS scores were done by paired t-tests for each group, and differences between final and initial scores were compared between sham-tDCS and real tDCS groups with unpaired t-test."|||0.05
70891768|NCT02091167|141269095|OTHER|||||||0.05|||||||Fisher Exact|||Two patients from each group were lost to follow-up after their discharge from the hospital.||||0.05
70891769|NCT00489970|141269105|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% confidence interval (CI) for the difference between groups in the seroprotection rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against diphtheria antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in percentage|1.41|||||TWO_SIDED|97.5|-1.16|4.17|||||Standardized asymptotic 97.5% CI for the group difference in the seroprotection rate was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group and Control group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to seroprotection rate against diphtheria antigen, one month following vaccination.||4.17|-1.16|
70891770|NCT00489970|141269105|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% confidence interval (CI) for the difference between groups in the seroprotection rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against tetanus antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in percentage|0.31|||||TWO_SIDED|97.5|-1.52|2.07|||||Standardized asymptotic 97.5% CI for the group difference in the seroprotection rate was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group and Control group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to seroprotection rate against tetanus antigen, one month following vaccination.||2.07|-1.52|
70891771|NCT00489970|141269105|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the seroprotection rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against diphtheria antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in percentage|1.32|||||TWO_SIDED|97.5|-3.41|4.15|||||Standardized asymptotic 97.5% CI for the group difference in the seroprotection rate was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group and Control group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to seroprotection rate against diphtheria antigen, one month following vaccination.||4.15|-3.41|
70891772|NCT00489970|141269105|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the seroprotection rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against tetanus antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in percentage|0.31|||||TWO_SIDED|97.5|-3.69|2.07|||||Standardized asymptotic 97.5% CI for the group difference in the seroprotection rate was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group and Control group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to seroprotection rate against tetanus antigen, one month following vaccination.||2.07|-3.69|
70891773|NCT00489970|141269107|NON_INFERIORITY|One month after vaccination, the lower limits of the 97.5% CIs for the anti-PT GMC ratios (Boostrix Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|1.53|||||TWO_SIDED|97.5|1.31|1.79|||GMC ratio|The associated CI was derived using the method proposed by G.Y. Zou and A. Donner \[Zou, 2008\]||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Boostrix Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-PT one month following vaccination||1.79|1.31|
70891774|NCT00489970|141269107|NON_INFERIORITY|One month after vaccination, the lower limits of the 97.5% CIs for the anti-FHA GMC ratios (Boostrix Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|5.27|||||TWO_SIDED|97.5|4.62|6.01|||GMC ratio|The associated CI was derived using the method proposed by G.Y. Zou and A. Donner \[Zou, 2008\]||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Boostrix Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-FHA one month following vaccination||6.01|4.62|
70891775|NCT00489970|141269107|NON_INFERIORITY|One month after vaccination, the lower limits of the 97.5% CIs for the anti-PRN GMC ratios (Boostrix Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|3.62|||||TWO_SIDED|97.5|3.07|4.25|||GMC ratio|The associated CI was derived using the method proposed by G.Y. Zou and A. Donner \[Zou, 2008\]||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Boostrix Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-PRN one month following vaccination||4.25|3.07|
70891776|NCT00489970|141269107|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|One month after vaccination, the lower limits of the 97.5% CIs for the anti-PT GMC ratios (Adacel Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|1.64||||||97.5|1.33|2.03|||GMC ratio|The associated CI was derived using the method proposed by G.Y. Zou and A. Donner \[Zou, 2008\]||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Adacel Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-PT one month following vaccination||2.03|1.33|
70891777|NCT00489970|141269107|NON_INFERIORITY|One month after vaccination, the lower limits of the 97.5% CIs for the anti-FHA GMC ratios (Adacel Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|5.27|||||TWO_SIDED|97.5|4.37|6.36|||GMC ratio|The associated CI was derived using the method proposed by G.Y. Zou and A. Donner \[Zou, 2008\]||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Adacel Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-FHA one month following vaccination||6.36|4.37|
70891778|NCT00489970|141269107|NON_INFERIORITY|One month after vaccination, the lower limits of the 97.5% CIs for the anti-PRN GMC ratios (Adacel Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|4.47|||||TWO_SIDED|97.5|3.58|5.57|||GMC ratio|The associated CI was derived using the method proposed by G.Y. Zou and A. Donner \[Zou, 2008\]||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Adacel Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-PRN one month following vaccination||5.57|3.58|
70891779|NCT00489970|141269108|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against diphtheria antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-5.91|||||TWO_SIDED|97.5|-14.67|2.85|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against diphtheria antigen, one month following vaccination.||2.85|-14.67|
70891780|NCT00489970|141269108|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against tetanus antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-1.44|||||TWO_SIDED|97.5|-10.63|7.79|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against tetanus antigen, one month following vaccination.||7.79|-10.63|
70891781|NCT00489970|141269108|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against diphtheria antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-8.56|||||TWO_SIDED|97.5|-20.33|2.73|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against diphtheria antigen, one month following vaccination.||2.73|-20.33|
70891782|NCT00489970|141269108|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against tetanus antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-11.79|||||TWO_SIDED|97.5|-22.98|0.15|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against tetanus antigen, one month following vaccination.||0.15|-22.98|
70891783|NCT00489970|141269109|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against PT antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-2.85|||||TWO_SIDED|97.5|-9.09|3.08|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against PT antigen, one month following vaccination.||3.08|-9.09|
70891784|NCT00489970|141269109|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against FHA antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-7.05|||||TWO_SIDED|97.5|-13.16|-1.4|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against FHA antigen, one month following vaccination.||-1.40|-13.16|
70891785|NCT00489970|141269109|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against PRN antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-10.32|||||TWO_SIDED|97.5|-17.5|-3.38|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against PRN antigen, one month following vaccination.||-3.38|-17.50|
70891786|NCT00489970|141269109|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against PT antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-1.24|||||TWO_SIDED|97.5|-10.03|5.57|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against PT antigen, one month following vaccination.||5.57|-10.03|
70891787|NCT00489970|141269109|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against FHA antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|4.01|||||TWO_SIDED|97.5|-2.38|8.66|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against FHA antigen, one month following vaccination.||8.66|-2.38|
70891788|NCT00489970|141269109|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against PRN antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response|-4.76|||||TWO_SIDED|97.5|-14.53|3.18|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against PRN antigen, one month following vaccination.||3.18|-14.53|
70891789|NCT00116805|141269134|NON_INFERIORITY_OR_EQUIVALENCE|With a sample size of 160 subjects in the TDF group and 80 subjects in the ADV group, a two group large-sample normal approximation test of proportions with a one-sided 0.025 significance level would have 95% power to reject the null hypothesis that the TDF treatment was inferior to the ADV treatment (the difference in proportions was less than -0.080) in favor of the alternative hypothesis that the TDF treatment was not inferior.|Difference in proportions|54.1|STANDARD_ERROR_OF_MEAN|4.8|<|0.001|TWO_SIDED|95.0|44.6|63.6||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted (baseline ALT ≤ 4 x upper limit of the normal range \[ULN\] or \> 4 x ULN) difference is 0.|Z-test|2-sided 95% confidence interval (CI), stratified by baseline ALT was used to evaluate difference between groups in proportion of complete responders.||||63.6|44.6|<0.001
70891790|NCT00116805|141269135|SUPERIORITY_OR_OTHER||Difference in proportions|63.1|STANDARD_ERROR_OF_MEAN|4.7|<|0.001|TWO_SIDED|95.0|53.8|72.3||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference in zero.|Z-test|Difference, standard error of the difference, and the CI are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).||||72.3|53.8|<0.001
70891791|NCT00116805|141269136|SUPERIORITY_OR_OTHER||Difference in proportions|-1.4|STANDARD_ERROR_OF_MEAN|5.4||0.801|TWO_SIDED|95.0|-12.0|9.3||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference is zero.|Z-test|Two-sided 95% CIs, stratified by baseline ALT (baseline ALT ≤ 4 x ULN or \> 4 x ULN), were used to evaluate treatment group differences.||||9.3|-12.0|0.801
70891792|NCT00116805|141269141|SUPERIORITY_OR_OTHER||Difference in proportions|5.8|STANDARD_ERROR_OF_MEAN|5.8||0.32|TWO_SIDED|95.0|-5.6|17.2||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference in zero. Difference, standard error of the difference, and the CI are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).|Z-test|||||17.2|-5.6|0.320
70891793|NCT00116805|141269147|SUPERIORITY_OR_OTHER||Difference in proportions|13.6|STANDARD_ERROR_OF_MEAN|6.4||0.032|TWO_SIDED|95.0|1.1|26.1||P-value corresponds to a Z-test. Statistical tests were not adjusted for baseline ALT stratum.|Z-test|Difference, standard error of the difference, and CI are stratum adjusted (baseline ALT ≤ 4 x ULN or \> 4 x ULN).||||26.1|1.1|0.032
70891794|NCT00116805|141269148|SUPERIORITY_OR_OTHER||Difference in proportions|-9.8|STANDARD_ERROR_OF_MEAN|6.0||0.1|TWO_SIDED|95.0|-21.5|1.9||P-value corresponds to a Z-test of the null hypothesis that the ALT stratum-adjusted difference is zero.|Z-test|Difference, standard error of the difference, and CI are stratum adjusted (baseline ALT ≤ 4 x ULN or \> 4 x ULN).||||1.9|-21.5|0.100
70891795|NCT00116805|141269153|SUPERIORITY_OR_OTHER||Difference in proportions|6.1|STANDARD_ERROR_OF_MEAN|5.3||0.245|TWO_SIDED|95.0|-4.2|16.4||P-value above for HBeAg loss corresponds to a Z-test of the null hypothesis that stratum-adjusted difference is zero.|Z-test|Difference, standard error of the difference, and Cl are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).||This information pertains to HBeAg loss.||16.4|-4.2|0.245
70891796|NCT00116805|141269153|SUPERIORITY_OR_OTHER||Difference in proportions|4.7|STANDARD_ERROR_OF_MEAN|5.2||0.363|TWO_SIDED|95.0|-5.5|14.9||P-value for HBeAg seroconversion corresponds to Z-test of the null hypothesis that stratum-adjusted difference is zero.|Z-test|Difference, standard error of difference, and Cl are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).||This information pertains to HBeAg seroconversion.||14.9|-5.5|0.363
70891797|NCT00116805|141269154|SUPERIORITY_OR_OTHER||Difference in proportions|0.3|STANDARD_ERROR_OF_MEAN|5.9||0.963|TWO_SIDED|95.0|-11.3|11.9||P-value above for HBeAg loss corresponds to a Z-test of the null hypothesis that stratum-adjusted difference is zero.|Z-test|Difference, standard error of the difference, and Cl are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).||This information pertains to HBeAg loss.||11.9|-11.3|0.963
70891798|NCT00116805|141269154|SUPERIORITY_OR_OTHER||Difference in proportions|0.7|STANDARD_ERROR_OF_MEAN|5.6||0.904|TWO_SIDED|95.0|-10.4|11.7||P-value above for HBeAg loss corresponds to a Z-test of the null hypothesis that stratum-adjusted difference is zero.|Z-test|Difference, standard error of the difference, and Cl are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \>4 x ULN).||This information pertains to seroconversion to anti-HBe.||11.7|-10.4|0.904
70891799|NCT00116805|141269155|SUPERIORITY_OR_OTHER||Difference in proportions|10.9|STANDARD_ERROR_OF_MEAN|4.6||0.018|TWO_SIDED|95.0|1.9|19.9||P-value corresponds to a Z-test of the null hypothesis that the ALT stratum-adjusted difference is zero. Difference, standard error of the difference, and confidence interval (CI) are stratum adjusted (baseline ALT ≤ 4 x ULN or \> 4 x ULN).|Z-test|||This information pertains to HBsAg loss.||19.9|1.9|0.018
70891800|NCT00116805|141269155|SUPERIORITY_OR_OTHER||Difference in proportions|4.3|STANDARD_ERROR_OF_MEAN|3.0||0.148|TWO_SIDED|95.0|-1.5|10.2||P-value corresponds to a Z-test of the null hypothesis that the ALT stratum-adjusted difference is zero. Difference, standard error of the difference, and confidence interval (CI) are stratum adjusted (baseline ALT ≤ 4 x ULN or \> 4 x ULN).|Z-test|||This information pertains to HBsAg seroconversion.||10.2|-1.5|0.148
70891801|NCT00116805|141269156|SUPERIORITY_OR_OTHER||Difference in proportions|0.9|STANDARD_ERROR_OF_MEAN|2.9||0.757|TWO_SIDED|95.0|-4.8|6.5||P-value above for HBsAg loss corresponds to a Z-test of the null hypothesis that stratum-adjusted difference is zero. Difference, standard error of the difference, and CI are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).|Z-test|||This information pertains to HBsAg loss.||6.5|-4.8|0.757
70891802|NCT00116805|141269156|SUPERIORITY_OR_OTHER||Difference in proportions|0.9|STANDARD_ERROR_OF_MEAN|2.6||0.733|TWO_SIDED|95.0|-4.2|5.9||P-value above corresponds to Z-test of the null hypothesis that stratum-adjusted difference is zero. Difference, standard error of the difference, and CI are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).|Z-test|||This information pertains to seroconversion to anti-HBs.||5.9|-4.2|0.733
70891803|NCT01159938|141269182|SUPERIORITY_OR_OTHER||LS mean difference|0.26||||0.617|TWO_SIDED|95.0|-0.78|1.3||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||1.30|-0.78|0.617
70891804|NCT01159938|141269182|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.732|TWO_SIDED|95.0|-1.23|1.73||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||1.73|-1.23|0.732
70891805|NCT01159938|141269182|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27||||0.715|TWO_SIDED|95.0|-1.2|1.73||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||1.73|-1.20|0.715
70891806|NCT01159938|141269182|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.35||||0.177|TWO_SIDED|95.0|-0.85|0.16||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in brachial arteries. Significance was assessed at 2-sided 5% level.|ANCOVA|||||0.16|-0.85|0.177
70891807|NCT01159938|141269182|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.579|TWO_SIDED|95.0|-0.94|0.53||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.53|-0.94|0.579
70891808|NCT01159938|141269182|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.49||||0.167|TWO_SIDED|95.0|-1.19|0.21||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in brachial arteries. Significance was assessed at 2-sided 5% level.|ANCOVA|||||0.21|-1.19|0.167
70891809|NCT01159938|141269183|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.676|TWO_SIDED|95.0|-1.1|0.72||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.72|-1.10|0.676
70891810|NCT01159938|141269183|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.957|TWO_SIDED|95.0|-1.27|1.34||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||1.34|-1.27|0.957
70891811|NCT01159938|141269183|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.41||||0.513|TWO_SIDED|95.0|-1.68|0.85||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.85|-1.68|0.513
70891812|NCT01159938|141269183|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09||||0.623|TWO_SIDED|95.0|-0.47|0.28||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.28|-0.47|0.623
70891813|NCT01159938|141269183|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.916|TWO_SIDED|95.0|-0.51|0.57||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.57|-0.51|0.916
70891814|NCT01159938|141269183|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21||||0.413|TWO_SIDED|95.0|-0.73|0.31||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.31|-0.73|0.413
70891815|NCT01159938|141269184|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.724|TWO_SIDED|95.0|-0.94|1.34||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 120-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||1.34|-0.94|0.724
70891816|NCT01159938|141269184|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.479|TWO_SIDED|95.0|-1.05|2.2||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 120-min post-breakfast in aortic arteries. Significance was assessed at 2-sided 5% level.|ANCOVA|||||2.20|-1.05|0.479
70891817|NCT01159938|141269184|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.18||||0.825|TWO_SIDED|95.0|-1.76|1.41||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 120-min post-breakfast in aortic arteries. Significance was assessed at 2-sided 5% level.|ANCOVA|||||1.41|-1.76|0.825
70891818|NCT01159938|141269184|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.378|TWO_SIDED|95.0|-0.65|0.25||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 120-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.25|-0.65|0.378
70891819|NCT01159938|141269184|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.553|TWO_SIDED|95.0|-0.84|0.46||The p-value is for the LS mean difference (high minus low postprandial glucose) in PWV at 120 mins post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.46|-0.84|0.553
70891820|NCT01159938|141269184|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.512|TWO_SIDED|95.0|-0.83|0.42||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 120-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.42|-0.83|0.512
70891821|NCT01159938|141269185|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29||||0.466|TWO_SIDED|95.0|-1.09|0.51||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.51|-1.09|0.466
70891822|NCT01159938|141269185|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.44||||0.449|TWO_SIDED|95.0|-1.6|0.72||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.72|-1.60|0.449
70891823|NCT01159938|141269185|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.15||||0.792|TWO_SIDED|95.0|-1.25|0.96||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.96|-1.25|0.792
70891824|NCT01159938|141269185|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.16||||0.493|TWO_SIDED|95.0|-0.63|0.31||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.31|-0.63|0.493
70891825|NCT01159938|141269185|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58||||0.091|TWO_SIDED|95.0|-1.25|0.1||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.10|-1.25|0.091
70891826|NCT01159938|141269185|SUPERIORITY_OR_OTHER||LS Mean Difference|0.26||||0.425|TWO_SIDED|95.0|-0.39|0.9||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.90|-0.39|0.425
70891827|NCT01159938|141269186|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48||||0.275|TWO_SIDED|95.0|-1.36|0.4||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.40|-1.36|0.275
70891828|NCT01159938|141269186|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17||||0.784||95.0|-1.44|1.1||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||1.10|-1.44|0.784
70891829|NCT01159938|141269186|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.79||||0.197|TWO_SIDED|95.0|-2.01|0.43||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.43|-2.01|0.197
70891830|NCT01159938|141269186|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.122|TWO_SIDED|95.0|-0.9|0.11||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.11|-0.90|0.122
70891831|NCT01159938|141269186|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.43||||0.246|TWO_SIDED|95.0|-1.16|0.31||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.31|-1.16|0.246
70891832|NCT01159938|141269186|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.37||||0.298|TWO_SIDED|95.0|-1.06|0.33||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.33|-1.06|0.298
70891833|NCT01159938|141269187|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.49||||0.024|TWO_SIDED|95.0|-6.5|-0.48||P-value is for the Least Square (LS) mean difference (high minus low postprandial glucose) in change in PWA at 60-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.||||-0.48|-6.50|0.024
70891834|NCT01159938|141269187|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.859|TWO_SIDED|95.0|-2.59|3.09||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 60-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|The LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||3.09|-2.59|0.859
70891835|NCT01159938|141269187|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.19||||0.155|TWO_SIDED|95.0|-5.25|0.87||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 120-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||0.87|-5.25|0.155
70891836|NCT01159938|141269187|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58||||0.685|TWO_SIDED|95.0|-3.46|2.3||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 120-min post-breakfast. Significance was assessed at 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||2.30|-3.46|0.685
70891837|NCT01159938|141269187|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.84||||0.292|TWO_SIDED|95.0|-5.33|1.64||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 180-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||1.64|-5.33|0.292
70891838|NCT01159938|141269187|SUPERIORITY_OR_OTHER||LS Mean Difference|2.04||||0.216|TWO_SIDED|95.0|-1.25|5.33||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 180-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||5.33|-1.25|0.216
70891839|NCT01159938|141269187|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.87||||0.065|TWO_SIDED|95.0|-5.92|0.18||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 240-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||0.18|-5.92|0.065
70891840|NCT01159938|141269187|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.954|TWO_SIDED|95.0|-2.96|2.8||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 240-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||2.80|-2.96|0.954
70891841|NCT01159938|141269188|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.905|TWO_SIDED|95.0|-0.31|0.27||P-value is for Least Square (LS) mean difference (high minus low postprandial glucose) in change in PAT at 120-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||0.27|-0.31|0.905
70891842|NCT01159938|141269188|SUPERIORITY_OR_OTHER||LS Mean Difference|0.42||||0.004|TWO_SIDED|95.0|0.14|0.69||P-value is for LS mean difference (high minus low postprandial glucose) in change in PAT at 120-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||0.69|0.14|0.004
70891843|NCT01159938|141269188|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09||||0.584|TWO_SIDED|95.0|-0.41|0.23||P-value is for LS mean difference (high minus low postprandial glucose) in change in PAT at 240-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||0.23|-0.41|0.584
70891844|NCT01159938|141269188|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.436|TWO_SIDED|95.0|-0.19|0.44||P-value is for LS mean difference (high minus low postprandial glucose) in change in PAT at 240-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||0.44|-0.19|0.436
70891845|NCT04088097|141269198|SUPERIORITY|||||||0.01|||||||ANOVA|||||||.01
70891846|NCT04088097|141269199|SUPERIORITY|||||||0.75|||||||ANOVA|||||||.75
70891847|NCT04088097|141269200|SUPERIORITY|||||||0.03|||||||ANOVA|||||||.03
70891848|NCT03556761|141269202|SUPERIORITY||Risk Ratio (RR)|0.4||||0.03|TWO_SIDED|95.0|0.2|0.81|||Regression, Linear|||||0.81|0.20|0.03
70891849|NCT03556761|141269203|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.12|TWO_SIDED|95.0|0.95|1.51|||Regression, Cox|||||1.51|0.95|0.12
70891850|NCT03556761|141269204|SUPERIORITY||Risk Ratio (RR)|0.55||||0.14|TWO_SIDED|95.0|0.25|1.21|||Chi-squared|||||1.21|0.25|0.14
70891851|NCT03556761|141269205|SUPERIORITY||Risk Ratio (RR)|0.87||||0.36|TWO_SIDED|95.0|0.64|1.18|||Chi-squared|||||1.18|0.64|0.36
70891852|NCT03556761|141269206|SUPERIORITY||Risk Ratio (RR)|0.02||||0.76|TWO_SIDED|95.0|-0.09|0.13|||Regression, Linear|||||.13|-0.09|0.76
70891853|NCT03556761|141269207|SUPERIORITY|||||||0.62|||||||Fisher Exact|||||||0.62
70891854|NCT03556761|141269208|SUPERIORITY||Risk Ratio (RR)|3.0|||||TWO_SIDED|95.0|0.32|28.59||||||||28.59|0.32|
70891855|NCT03556761|141269209|SUPERIORITY||Risk Ratio (RR)|0.61||||0.03|TWO_SIDED|95.0|0.39|0.96|||Chi-squared|||||0.96|0.39|0.03
70891856|NCT00693992|141269214|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.0006|TWO_SIDED|95.0|0.47|0.82|||Log Rank|||||0.82|0.47|0.0006
70891857|NCT00693992|141269215|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.89|TWO_SIDED|95.0|0.73|1.31|||Log Rank|||||1.31|0.73|0.89
70891858|NCT00693992|141269217|SUPERIORITY|||||||0.0061|||||||Fisher Exact|||||||0.0061
70891859|NCT00693992|141269218|SUPERIORITY|||||||0.8393|||||||Fisher Exact|||||||0.8393
70891860|NCT01303627|141269231|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Statistical analyses were performed x2 test or Mann Whitney U test as approriate. A p value of \<0.05 was considered statistically significant.|Chi-squared|||The incidence of complications on removal of the cLMA has been reported 54 % in awake patients group A power analysis indicated that a minimum 16 patients in each group were required to demonstrate a difference that 50% reduction the complications (a power of 80% and α error 0.05).||||<0.05
70891861|NCT01054820|141269250|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided|||Null hypothesis: no change from baseline. Study powered at 95 percent (%) to detect a mean change of at least 1.2 units, with assumed standard deviation of at most 3.2 units.||||<0.0001
70891862|NCT01054820|141269251|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|McNemar|||||||<0.0001
70891863|NCT01054820|141269252|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided|||||||<0.0001
70891864|NCT01054820|141269253|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided|||||||<0.0001
70891865|NCT01054820|141269254|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided|||||||<0.0001
70891866|NCT01054820|141269255|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided|||||||<0.0001
70891867|NCT01054820|141269258|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided|||||||<0.0001
70891868|NCT01154166|141269264|SUPERIORITY_OR_OTHER||Adjusted mean for treatment difference|-1.76|||<|0.001|TWO_SIDED|95.0|-2.27|-1.26|||ANCOVA||The estimated value indicates the treatment difference for the adjusted mean for Ropinirole PR and placebo.|||-1.26|-2.27|<0.001
70891869|NCT02019719|141269302|SUPERIORITY_OR_OTHER||E0 (g/dL)|-1.37|||||TWO_SIDED|95.0|-1.72|-1.03|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||-1.03|-1.72|
70891870|NCT02019719|141269302|SUPERIORITY_OR_OTHER||ED50 (mg)|21.88|||||TWO_SIDED|95.0|9.99|42.64|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||42.64|9.99|
70891871|NCT02019719|141269302|SUPERIORITY_OR_OTHER||Emax (g/dL)|5.88|||||TWO_SIDED|95.0|3.2|8.61|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||8.61|3.20|
70891872|NCT02019719|141269302|SUPERIORITY_OR_OTHER||Gamma|1.13|||||TWO_SIDED|95.0|0.7|1.68|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||1.68|0.70|
70891873|NCT02019719|141269302|SUPERIORITY_OR_OTHER||Var|0.66|||||TWO_SIDED|95.0|0.5|0.88|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||0.88|0.50|
70891874|NCT02019719|141269302|SUPERIORITY_OR_OTHER||MED (mg)|1.98|||||TWO_SIDED|95.0|0.75|3.41|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||3.41|0.75|
70891875|NCT02019719|141269302|SUPERIORITY_OR_OTHER||TD (mg)|3.9|||||TWO_SIDED|95.0|2.2|5.63|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||5.63|2.20|
70891876|NCT02019719|141269302|SUPERIORITY_OR_OTHER||MAD (mg)|8.65|||||TWO_SIDED|95.0|6.51|11.44|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||11.44|6.51|
70891877|NCT04535037|141269320|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 2-sided 95% confidence interval (CI) of group GMC ratio (Infanrix Hexa over Vaxelis group) was above 0.5.|Adjusted GMC Ratio|0.917|||||TWO_SIDED|95.0|0.71|1.185||||The 95% CI for GMC ratio derived from an ANOVA model on log10 transformed concentration was used. GMC was adjusted for DTPA vaccination of the mother.||To demonstrate that the Haemophilus influenzae type b(Hib) response of Infanrix Hexa Group is non-inferior to the Vaxelis Group in terms of anti-PRP GMCs, 1 month post-booster vaccination.||1.185|0.710|
70891878|NCT04535037|141269321|NON_INFERIORITY|Non-inferiority was demonstrated if the non inferiority of anti-PRP GMC ratio was met and the LL of the 2 sided 95% CI on group difference in the percentage (Infanrix Hexa over Vaxelis group) was more than -10%.|Difference in Percentage|-6.3|||||TWO_SIDED|95.0|-14.1|1.49||||The 2 sided 95% CI of group difference in seroconversion rate (Inv\_group minus Com\_group) was computed based on Miettinen and Nurminen method.||To demonstrate that the Hib response in Infanrix Hexa group is non-inferior to Vaxelis Group in terms of percentage of subjects with anti-PRP antibody concentrations ≥ 5 µg/mL, 1 month post-booster vaccination.||1.49|-14.10|
70891879|NCT02165722|141269352|OTHER|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention.|||||<|0.001||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention.||||||<0.001
70891880|NCT02165722|141269352|OTHER|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention.|||||<|0.001||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention.||||||<0.001
70891881|NCT02165722|141269352|OTHER|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention between intervention and control clinics.|||||<|0.001||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|||Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention between intervention and control clinics.||||<0.001
70891882|NCT02165722|141269352|OTHER|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention between intervention and control clinics.|||||<|0.001||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|||||||<0.001
70891883|NCT02165722|141269353|OTHER|Chi-square tests performed to test for differences in cumulative HPV series completion vaccination rates from baseline to post-intervention.||||||0.001||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|Chi-square tests performed to test for differences in cumulative HPV series completion vaccination rates from baseline to post-intervention.||||||0.001
70891884|NCT02165722|141269353|OTHER|Chi-square tests performed to test for differences in cumulative HPV series completion vaccination rates from baseline to post-intervention.|||||>|0.05||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|||||||>0.05
70891885|NCT02165722|141269353|OTHER|Chi-square tests performed to test for differences in cumulative HPV series completion vaccination rates from baseline to post-intervention between intervention and control clinics.|||||>|0.05||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|||||||>0.05
70891886|NCT02165722|141269353|OTHER|Chi-square tests performed to test for differences in cumulative HPV series completion vaccination rates from baseline to post-intervention between intervention and control clinics.|||||>|0.05||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|||||||>0.05
70891887|NCT02731131|141269365|SUPERIORITY_OR_OTHER|||||||0.3|||||||Fisher Exact|||||||0.30
70891888|NCT02731131|141269367|SUPERIORITY_OR_OTHER|||||||0.22|||||||Fisher Exact|||||||0.22
70891889|NCT02731131|141269368|SUPERIORITY_OR_OTHER|||||||0.3|||||||Fisher Exact|||||||0.30
70891890|NCT02731131|141269369|SUPERIORITY_OR_OTHER|||||||0.3|||||||Fisher Exact|||||||0.30
70891891|NCT02731131|141269370|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||||||0.50
70891892|NCT01614210|141269420|OTHER||percentage decrease in Ki67 after 7 days|||||0.0001|||||||t-test, 1 sided|||||||0.0001
70891893|NCT04321460|141269441|SUPERIORITY||Odds Ratio (OR)|4.564||||0.007|TWO_SIDED|95.0|1.66|16.039|||Wilcoxon (Mann-Whitney)|||||16.039|1.66|0.007
70891894|NCT04321460|141269442|SUPERIORITY||Odds Ratio (OR)|4.716||||0.002|TWO_SIDED|95.0|1.898|14.268|||Wilcoxon (Mann-Whitney)|||||14.268|1.898|0.002
70891895|NCT04495712|141269455|SUPERIORITY|||||||0.71|||||||Log Rank|||||||0.71
70891896|NCT04495712|141269456|SUPERIORITY|||||||0.07|||||||Log Rank|||||||0.07
70891897|NCT04495712|141269457|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||||||0.42
70891898|NCT00706121|141269461|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.96||||0.96|TWO_SIDED|95.0|0.9|1.02|||Log binomial regression|||||1.02|0.9|0.96
70891899|NCT00706121|141269462|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.92||||0.32|TWO_SIDED|95.0|0.78|1.08|||Log binomial regression|||||1.08|0.78|0.32
70891900|NCT00706121|141269464|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.91||||0.24|TWO_SIDED|95.0|0.77|1.07|||Log binomial regression|||||1.07|0.77|0.24
70891901|NCT00706121|141269465|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.03||||0.38|TWO_SIDED|95.0|0.96|1.1|||Log binomial regression|||||1.10|0.96|0.38
70891902|NCT01308749|141269470|OTHER||||||||||||||||||No analyses were completed, this is descriptive only and is an absolute value (number of participants).|||
70891903|NCT01308749|141269474|EQUIVALENCE|Within group test of difference using t-scores adjusted by baseline score, no correction for multiple comparisons, nonparametric model||||||0.023|||||||t-test, 2 sided|||||||0.023
70891904|NCT01308749|141269476|EQUIVALENCE|t-test between groups||||||0.23|||||||t-test, 2 sided|no adjustment for multiple comparison. non parametric||||||0.23
70891905|NCT01666002|141269556|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
70891906|NCT01666002|141269557|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70891907|NCT02703844|141269560|SUPERIORITY|||||||0.0089|||||||ANCOVA|||||||0.0089
70891908|NCT02828111|141269575|OTHER|Pairwise comparison||||||0.132|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.132
70891909|NCT02828111|141269575|OTHER|Pairwise comparison||||||0.658|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.658
70891910|NCT02828111|141269575|OTHER|Pairwise comparison||||||0.142|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.142
70891911|NCT02828111|141269575|OTHER|Pairwise comparison||||||0.207|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.207
70891912|NCT02828111|141269575|OTHER|Pairwise comparison||||||0.077|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||This is the analysis of combined patidegib gel 2% once daily and twice daily compared with vehicle gel at Week 12.||||0.077
70891913|NCT02828111|141269575|OTHER|Pairwise comparison||||||0.331|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||This is the analysis of combined patidegib gel 4% once daily and twice daily compared with vehicle gel at Week 12.||||0.331
70891914|NCT02828111|141269575|OTHER|Pairwise comparison||||||0.117|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||This is the analysis of all four patidegib gel treatment groups combined compared with vehicle gel at Week 12.||||0.117
70891915|NCT02828111|141269579|OTHER|Pairwise comparison||||||0.038|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.038
70891916|NCT02828111|141269579|OTHER|Pairwise comparison||||||0.099|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.099
70891917|NCT02828111|141269579|OTHER|Pairwise comparison||||||0.198|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.198
70891918|NCT02828111|141269579|OTHER|Pairwise comparison||||||0.757|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.757
70891919|NCT02828111|141269580|OTHER|Pairwise comparison||||||0.043|||||||Fisher Exact|||at Week 12||||0.043
70891920|NCT02828111|141269580|OTHER|Pairwise comparison||||||0.312|||||||Fisher Exact|||at Week 12||||0.312
70891921|NCT02828111|141269580|OTHER|Pairwise comparison||||||0.353|||||||Fisher Exact|||at Week 12||||0.353
70891922|NCT02828111|141269580|OTHER|Pairwise comparison||||||0.093|||||||Fisher Exact|||This is the analysis of combined patidegib gel 2% once daily and twice daily compared with vehicle gel at Week 12.||||0.093
70891923|NCT02828111|141269580|OTHER|Pairwise comparison||||||1|||||||Fisher Exact|||This is the analysis of combined patidegib gel 4% once daily and twice daily compared with vehicle gel at Week 12.||||1.000
70891924|NCT02828111|141269580|OTHER|Pairwise comparison||||||0.157|||||||Fisher Exact|||This is the analysis of all four patidegib gel treatment groups combined compared with combined vehicle gel at Week 12.||||0.157
70891925|NCT00736996|141269603|SUPERIORITY_OR_OTHER||||||<|0.0125|TWO_SIDED|||||Statistical significance was defined as a 2-sided p-value \< 0.0125 (=0.05/4) to adjust for multiple comparisons.|Regression, Linear|||The mean change in domain score with PIO was compared with the mean change in domain score with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline domain score.||||<0.0125
70891926|NCT00736996|141269603|SUPERIORITY_OR_OTHER||||||<|0.0125|TWO_SIDED|||||Statistical significance was defined as a 2-sided p-value \< 0.0125 (=0.05/4) to adjust for multiple comparisons.|Regression, Linear|||The mean change in domain score with EET was compared with the mean change in domain score with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline domain score.||||<0.0125
70891927|NCT00736996|141269604|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Regression, Linear|||The mean change with PIO was compared with the mean change with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline level of the outcome variable.||||<0.05
70891928|NCT00736996|141269604|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Regression, Linear|||The mean change with EET was compared with the mean change with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline level of the outcome variable.||||<0.05
70891929|NCT00736996|141269605|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Regression, Linear|||The mean change with PIO was compared with the mean change with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline level of the outcome variable.||||<0.05
70891930|NCT00736996|141269605|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Regression, Linear|||The mean change with EET was compared with the mean change with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline level of the outcome variable.||||<0.05
70891931|NCT02667912|141269617|SUPERIORITY||Mean Difference (Final Values)|10.8||||0.045|TWO_SIDED|95.0|0.3|21.4||The a priori threshold for statistical significance \<0.05|t-test, 2 sided|||||21.4|0.3|0.045
70891932|NCT02667912|141269620|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.96
70891933|NCT02667912|141269621|OTHER|||||||0.203|||||||t-test, 2 sided|||||||0.203
70891934|NCT02667912|141269622|SUPERIORITY||Mean Difference (Final Values)|-4.3||||0.27|TWO_SIDED|95.0|-11.9|3.4|||t-test, 2 sided|||||3.4|-11.9|0.27
70891935|NCT02667912|141269623|SUPERIORITY||Mean Difference (Final Values)|7.8|STANDARD_ERROR_OF_MEAN|5.7||0.17|TWO_SIDED|95.0|-3.7|19.3||The a priori threshold for statistical significance p\<0.05|t-test, 2 sided|||||19.3|-3.7|0.17
70891936|NCT02667912|141269626|SUPERIORITY|||||||0.213|||||||t-test, 2 sided|||||||0.213
70891937|NCT02667912|141269627|SUPERIORITY|||||||0.041|||||||t-test, 2 sided|||||||0.041
70891938|NCT02667912|141269628|OTHER|||||||0.304|||||||t-test, 2 sided|||||||0.304
70891939|NCT02667912|141269629|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||||||0.49
70891940|NCT02667912|141269630|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||||||0.66
70891941|NCT02667912|141269631|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||||||0.59
70891942|NCT02667912|141269632|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||||||0.66
70891943|NCT02667912|141269633|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
70891944|NCT02667912|141269634|SUPERIORITY|||||||0.054|||||||t-test, 2 sided|||||||0.054
70891945|NCT02667912|141269635|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||||||0.204
70891946|NCT02667912|141269636|SUPERIORITY|||||||0.324|||||||t-test, 2 sided|||||||0.324
70891947|NCT02667912|141269637|SUPERIORITY|||||||0.217|||||||t-test, 2 sided|||||||0.217
70891948|NCT02667912|141269638|SUPERIORITY|||||||0.238|||||||t-test, 2 sided|||||||0.238
70891949|NCT02667912|141269639|SUPERIORITY|||||||0.969|||||||t-test, 2 sided|||||||0.969
70891950|NCT02667912|141269640|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||||||0.37
70891951|NCT05799495|141269664|OTHER||LS Mean difference|-0.671|STANDARD_ERROR_OF_MEAN|0.3178||0.0181|TWO_SIDED|80.0|-1.08|-0.262|||Mixed Models Analysis|||||-0.262|-1.080|0.0181
70891952|NCT05799495|141269664|OTHER||LS Mean difference|-0.802|STANDARD_ERROR_OF_MEAN|0.3562||0.0127|TWO_SIDED|80.0|-1.26|-0.344|||Mixed Models Analysis|||||-0.344|-1.260|0.0127
70891953|NCT05799495|141269664|OTHER||LS Mean difference|-1.167|STANDARD_ERROR_OF_MEAN|0.264|<|0.0001|TWO_SIDED|80.0|-1.506|-0.827|||Mixed Models Analysis|||||-0.827|-1.506|<.0001
70891954|NCT05799495|141269665|OTHER||LS Mean difference|-0.608|STANDARD_ERROR_OF_MEAN|0.3402||0.0378|TWO_SIDED|80.0|-1.046|-0.17|||Mixed Models Analysis|||Day 3||-0.170|-1.046|0.0378
70891955|NCT05799495|141269665|OTHER||LS Mean difference|-1.304|STANDARD_ERROR_OF_MEAN|0.3718||0.0003|TWO_SIDED|80.0|-1.782|-0.826|||Mixed Models Analysis|||Day 3||-0.826|-1.782|0.0003
70891956|NCT05799495|141269665|OTHER||LS Mean difference|-1.148|STANDARD_ERROR_OF_MEAN|0.2803|<|0.0001|TWO_SIDED|80.0|-1.509|-0.788|||Mixed Models Analysis|||Day 3||-0.788|-1.509|<.0001
70891957|NCT05799495|141269665|OTHER||LS Mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.2732||0.5931|TWO_SIDED|80.0|-0.287|0.416|||Mixed Models Analysis|||Day 10||0.416|-0.287|0.5931
70891958|NCT05799495|141269665|OTHER||LS Mean difference|0.006|STANDARD_ERROR_OF_MEAN|0.2914||0.508|TWO_SIDED|80.0|-0.369|0.381|||Mixed Models Analysis|||Day 10||0.381|-0.369|0.5080
70891959|NCT05799495|141269665|OTHER||LS Mean difference|-0.214|STANDARD_ERROR_OF_MEAN|0.223||0.1692|TWO_SIDED|80.0|-0.501|0.073|||Mixed Models Analysis|||Day 10||0.073|-0.501|0.1692
70891960|NCT05799495|141269665|OTHER||LS Mean difference|-0.239|STANDARD_ERROR_OF_MEAN|0.2004||0.1172|TWO_SIDED|80.0|-0.497|0.019|||Mixed Models Analysis|||Day 14||0.019|-0.497|0.1172
70891961|NCT05799495|141269665|OTHER||LS Mean difference|-0.056|STANDARD_ERROR_OF_MEAN|0.2178||0.3979|TWO_SIDED|80.0|-0.337|0.224|||Mixed Models Analysis|||Day 14||0.224|-0.337|0.3979
70891962|NCT05799495|141269665|OTHER||LS Mean difference|-0.383|STANDARD_ERROR_OF_MEAN|0.1655||0.0109|TWO_SIDED|80.0|-0.595|-0.17|||Mixed Models Analysis|||Day 14||-0.170|-0.595|0.0109
70891963|NCT02371369|141269680|OTHER|Treatment comparison analysis|||||<|0.0001|||||||Fisher's Exact Test|||Treatment comparison between the pexidartinib and placebo groups at Week 25||||<0.0001
70891964|NCT02371369|141269681|OTHER|Treatment comparison analysis||||||0.0043|||||||Fisher's Exact Test|||Treatment comparison between the pexidartinib and placebo groups at Week 25||||0.0043
70891965|NCT02371369|141269682|OTHER|Treatment comparison analysis|||||<|0.0001|||||||Fisher's Exact Test|||Treatment comparison between the pexidartinib and placebo groups at Week 25||||<0.0001
70891966|NCT02371369|141269683|OTHER|Treatment comparison analysis||||||0.0019|||||||Mixed effects model for repeated measure|||Treatment comparison between pexidartinib and placebo groups at Week 25||||0.0019
70891967|NCT02371369|141269684|OTHER|Treatment comparison analysis|||||<|0.0001|||||||Mixed effects model for repeated measure|||Treatment comparison between the pexidartinib and placebo groups at Week 25||||<0.0001
70891968|NCT02120924|141269734|EQUIVALENCE|Bioequivalence was established if the 90% CI for the ratio of Test/Reference means was contained within the interval \[0.80, 1.25\].|Mean Difference (Net)|0.98|||||TWO_SIDED|90.0|0.92|1.05|||||Bioequivalence was established if the 90% CI for the ratio of Test/Reference means was contained within the interval \[0.80, 1.25\].|The primary endpoint was the percent change from baseline to Week 12 in the inflammatory (papules and pustules) lesion counts in PP population.||1.05|0.92|
70891969|NCT02120924|141269735|EQUIVALENCE|A two-sided, continuity-corrected, 90% CI on the Test-to-Reference difference for the proportion of subjects with treatment success on the IGE was constructed.|Mean Difference (Net)|0.044|||||TWO_SIDED|90.0|-0.028|0.116|||||Bioequivalence was established if the 90% CI for the difference was contained within the interval \[-0.20, +0.20\].|||0.116|-0.028|
70891970|NCT01884350|141269736|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.24||||0.8117|TWO_SIDED|95.0|-2.18|1.7||P-value (two-sided) corresponds to the two-sample t-tests for difference in percentage of adherence at Week 24|t-test, 2 sided|||||1.7|-2.18|0.8117
70891971|NCT01884350|141269737|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value is from a paired t-test comparing percent adherence at 12 and 24 Weeks. Only participants with available data at both Study Days 85 and 169 are included.|paired t-test|||Percent adherence at 12 Weeks v. Percent adherence at 24 Weeks||||<0.0001
70891972|NCT01884350|141269737|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value is from a paired t-test comparing percent adherence at 12 and 24 Weeks. Only participants with available data at both Study Days 85 and 169 are included.|paired t-test|||Percent adherence at 12 Weeks v. Percent adherence at 24 Weeks||||<0.0001
70891973|NCT01884350|141269738|NON_INFERIORITY_OR_EQUIVALENCE|F-test p-value is obtained from the one-way ANOVA model||||||0.8707|||||||ANOVA|||||||0.8707
70891974|NCT01884350|141269738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.6399|TWO_SIDED|95.0|-2.88|4.68||P-values are obtained from the Cochran t-test for pairwise comparison between groups (two-sided).|t-test, 2 sided|||||4.68|-2.88|0.6399
70891975|NCT01884350|141269738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.9616|TWO_SIDED|95.0|-3.45|3.29||P-values are obtained from the Cochran t-test for pairwise comparison between groups (two-sided).|t-test, 2 sided|||||3.29|-3.45|0.9616
70891976|NCT01884350|141269738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82||||0.6341|TWO_SIDED|95.0|-2.6|4.24||P-values are obtained from the Cochran t-test for pairwise comparison between groups (two-sided).|t-test, 2 sided|||||4.24|-2.60|0.6341
70891977|NCT01884350|141269739|SUPERIORITY|||||||0.1924||||||\<=2 Drink/Day Average vs None|Wald Chi-square test|||||||0.1924
70891978|NCT01884350|141269739|SUPERIORITY|||||||0.0305||||||\>=3 Drink/Day Average vs None|Wald Chi-square test|||||||0.0305
70891979|NCT01884350|141269739|SUPERIORITY|||||||0.0107||||||Mini-mental state examination score|Wald Chi-square test|||||||0.0107
70891980|NCT01884350|141269739|SUPERIORITY|||||||0.6982||||||Higher managerial, administrative and professional occupations vs UKSOC1|Wald Chi-square test|||||||0.6982
70891981|NCT01884350|141269739|SUPERIORITY|||||||0.7277||||||Higher professional occupations vs UKSOC1|Wald Chi-square test|||||||0.7277
70891982|NCT01884350|141269739|SUPERIORITY|||||||0.7581||||||Intermediate occupations vs UKSOC1|Wald Chi-square test|||||||0.7581
70891983|NCT01884350|141269739|SUPERIORITY|||||||0.2328||||||Large employers and higher managerial and adm. occupations vs UKSOC1|Wald Chi-square test|||||||0.2328
70891984|NCT01884350|141269739|SUPERIORITY|||||||0.7507||||||Lower managerial, administrative and professional occupations vs UKSOC1|Wald Chi-square test|||||||0.7507
70891985|NCT01884350|141269739|SUPERIORITY|||||||0.0091||||||Lower supervisory and technical occupations vs UKSOC1|Wald Chi-square test|||||||0.0091
70891986|NCT01884350|141269739|SUPERIORITY|||||||0.673||||||Never worked and long-term unemployed vs UKSOC1|Wald Chi-square test|||||||0.6730
70891987|NCT01884350|141269739|SUPERIORITY|||||||0.0117||||||Routine occupations vs UKSOC1|Wald Chi-square test|||||||0.0117
70891988|NCT01884350|141269739|SUPERIORITY|||||||0.191||||||Semi-routine occupations vs UKSOC1|Wald Chi-square test|||||||0.1910
70891989|NCT01884350|141269739|SUPERIORITY|||||||0.9559||||||Paroxysmal vs Persistent Atrial Fibrillation|Wald Chi-square test|||||||0.9559
70891990|NCT01884350|141269739|SUPERIORITY|||||||0.0264||||||Permanent vs Persistant Atrial Fibrillation|Wald Chi-square test|||||||0.0264
70891991|NCT01884350|141269739|SUPERIORITY|||||||0.1087||||||\<=2 Drink/Day Average vs None|Wald Chi-square test|||||||0.1087
70891992|NCT01884350|141269739|SUPERIORITY|||||||0.0679||||||\>=3 Drink/Day Average vs None|Wald Chi-square test|||||||0.0679
70891993|NCT01884350|141269739|SUPERIORITY|||||||0.2128||||||Paroxysmal vs Persistant Atrial Fibrillation|Wald Chi-square test|||||||0.2128
70891994|NCT01884350|141269739|SUPERIORITY|||||||0.3739||||||Permanent vs Persistant Atrial Fibrillation|Wald Chi-square test|||||||0.3739
70891995|NCT01884350|141269739|SUPERIORITY|||||||0.843||||||VKA status: Naive vs. Non-Naive|Wald Chi-square test|||||||0.843
70891996|NCT02669329|141269786|OTHER||success proportion|85.2|||||TWO_SIDED|95.0|72.9|93.4||||||||93.4|72.9|
70891997|NCT01543256|141269788|NON_INFERIORITY|Non-Inferiority margin was 20%||||||0.008|||||||Exact non-inferiority|||||||.008
70891998|NCT01543256|141269789|SUPERIORITY|||||||0.568|||||||Fisher Exact|||||||.568
70891999|NCT01543256|141269790|SUPERIORITY||||||<|0.001|||||||Negative binomial|||||||<.001
70892000|NCT01543256|141269791|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||.99
70892001|NCT01543256|141269792|SUPERIORITY|||||||0.519|||||||Wilcoxon (Mann-Whitney)|||||||.519
70892002|NCT01543256|141269793|SUPERIORITY||||||<|0.001|||||||Negative binomial|||||||<.001
70892003|NCT02055352|141269835|NON_INFERIORITY_OR_EQUIVALENCE|A change of 5-10% from baseline values is considered to be clinically important. The estimated adjusted treatment difference for budesonide 400 μg twice a day/ indacaterol 150 μg once daily minus fixed combination of fluticasone/ salmeterol 250/ 50 μg twice daily was displayed along with the associated one-sided 97.5% confidence interval. If the lower limit of this confidence interval was to the right (i.e. above) - 10 mL, then non-inferiority could be claimed.||||||0.004|||||||Mixed effects General linear model|||||||0.004
70892004|NCT03809182|141269844|SUPERIORITY|||||||0.38|TWO_SIDED|95.0||||A p-value less than .05 was considered statistically significant.|Mixed Models Analysis|||Null hypothesis: There is no difference in plasmatic glucose levels between dexmedetomidine and 0.9% sodium-chloride groups.||||0.38
70892005|NCT03809182|141269845|SUPERIORITY|||||||0.02||||||A p-value less than .05 was considered statistically significant.|Mixed Models Analysis|||Null hypothesis: There is no difference in insulin levels between dexmedetomidine and 0.9% sodium-chloride groups.||||0.02
70892006|NCT02062502|141269851|NON_INFERIORITY_OR_EQUIVALENCE|The conclusion of non-inferiority (similarity) is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease equal to or more than the prespecified criterion of 10.0 percentage points for Varicella zoster virus.|Risk Difference (RD)|0.0|||<|0.001|TWO_SIDED|95.0|-3.2|3.2|||Miettinen and Nurminen|||||3.2|-3.2|<0.001
70892007|NCT02062502|141269852|NON_INFERIORITY_OR_EQUIVALENCE|The conclusion of non-inferiority (similarity) is based on the lower bound of the 2-sided 95% CI on fold-difference, excluding a decrease of 1.5 fold or more.|Risk Difference (RD)|0.95|||<|0.001|TWO_SIDED|95.0|0.85|1.06|||t-test, 2 sided|||||1.06|0.85|<0.001
70892008|NCT02062502|141269852|SUPERIORITY_OR_OTHER||Antibody Response Rate|97.2|||<|0.001|TWO_SIDED|95.0|94.4|98.9|||Exact CI method/binomial proportion|||The conclusion of acceptability is based on the lower bound of the 95% Confidence Interval (CI) being \>76%, and implies that the value of the parameter is statistically significantly greater than the prespecified acceptability criterion (76%).||98.9|94.4|<0.001
70892009|NCT03794089|141269858|SUPERIORITY|||||||0.035||||||a priori threshold for statistical significance was p\<=.05|ANCOVA|||comparisons of groups at post-assessment controls for baseline GAD-7 total scores||||0.035
70892010|NCT03794089|141269859|SUPERIORITY|||||||0.231||||||a priori threshold for statistical significance was p\<=0.05|ANCOVA|||comparisons of groups at post-assessment controls for baseline PHQ-9 total scores||||0.231
70892011|NCT03794089|141269860|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.393||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Anxiety subscale total from Baseline to 4 weeks||||0.393
70892012|NCT03794089|141269860|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.022||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Anxiety subscale total from Baseline to 8 weeks||||0.022
70892013|NCT03794089|141269860|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.013||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Anxiety subscale total from Baseline to 12 weeks||||0.013
70892014|NCT03794089|141269860|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.049||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Anxiety subscale total from Baseline to Post assessment (16 weeks)||||0.049
70892015|NCT03794089|141269861|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.008||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Depression subscale total from Baseline to 4 weeks||||0.008
70892016|NCT03794089|141269861|SUPERIORITY|Testing null hypothesis of no difference between groups|||||<|0.001||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Depression subscale total from Baseline to 8 weeks||||<0.001
70892017|NCT03794089|141269861|SUPERIORITY|Testing null hypothesis of no difference between groups|||||<|0.001||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Depression subscale total from Baseline to 12 weeks||||<0.001
70892018|NCT03794089|141269861|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.008||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Depression subscale total from Baseline to Post-assessment (16 weeks)||||0.008
70892019|NCT03794089|141269862|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.44||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Stress subscale total from Baseline to 4 weeks||||0.440
70892020|NCT03794089|141269862|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.022||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Stress subscale total from Baseline to 8 weeks||||0.022
70892021|NCT03794089|141269862|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.032||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Stress subscale total from Baseline to 12 weeks||||0.032
70892022|NCT03794089|141269862|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.091||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Stress subscale total from Baseline to Post-assessment (16 weeks)||||0.091
70892023|NCT03794089|141269863|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.058||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in OASIS total score from Baseline to 4 weeks||||0.058
70892024|NCT03794089|141269863|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.032||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in OASIS total score from Baseline to 8 weeks||||0.032
70892025|NCT03794089|141269863|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.007||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in OASIS total score from Baseline to 12 weeks||||0.007
70892026|NCT03794089|141269863|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.044||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in OASIS total score from Baseline to Post assessment (16 weeks)||||0.044
70892027|NCT03794089|141269864|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.328||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in ODSIS total from Baseline to 4 weeks||||0.328
70892028|NCT03794089|141269864|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.148||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in ODSIS total from Baseline to 8 weeks||||0.148
70892029|NCT03794089|141269864|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.002||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in ODSIS total from Baseline to 12 weeks||||0.002
70892030|NCT03794089|141269864|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.069||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in ODSIS total from Baseline to Post-assessment (16 weeks)||||0.069
70892031|NCT03794089|141269865|SUPERIORITY|||||||0.928||||||a priori threshold for statistical significance was p\<=0.05|ANCOVA|||comparisons of groups at post-assessment controls for baseline Q-LES-Q-SF total scores||||0.928
70892032|NCT03794089|141269866|SUPERIORITY|||||||0.402||||||a priori threshold for statistical significance was p\<.05|Fisher Exact|degrees of freedom = 1||Testing null hypothesis of no difference between groups||||0.402
70892033|NCT03794089|141269867|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance was p\<=.05|t-test, 2 sided|||Testing the null hypothesis of no difference between groups||||<0.001
70892034|NCT03794089|141269868|SUPERIORITY|||||||0.006||||||a priori threshold for statistical significance was p\<=.05|t-test, 2 sided|Used Satterthwaite method given unequal variances||Testing the null hypothesis of no difference between groups||||.006
70892035|NCT03794089|141269869|SUPERIORITY|||||||0.004||||||a priori threshold for statistical significance was p\<=.05|t-test, 2 sided|used Satterthwaite method given unequal variances||Testing the null hypothesis of no difference between groups||||0.004
70892036|NCT03794089|141269870|SUPERIORITY|||||||0.002||||||a priori threshold for statistical significance was p\<=.05|t-test, 2 sided|||Testing the null hypothesis of no difference between groups||||0.002
70892037|NCT03119766|141269882|SUPERIORITY||Mean Difference (Final Values)|0.94||||0.041|TWO_SIDED|95.0|0.04|1.85|||ANOVA||Results are presented as estimated differences of Least Squares Means according to ANOVA model|Mean changes of GIS scores after 8 weeks of treatment were compared.||1.85|0.04|0.041
70892038|NCT03119766|141269882|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.041|TWO_SIDED|95.0|0.04|1.74|||Mixed Models Analysis||"Fixed factor Treatment and random factor research center were used in mixed model. Difference in mean changes between groups was estimeted."|Mean changes of GIS scores after 8 weeks of treatment were compared. Influence of between center variation was estimated.||1.74|0.04|0.041
70892039|NCT03119766|141269883|SUPERIORITY|||||||0.067|||||||Fisher Exact|||Test for comparison percentage of patients with reduction ≥ 1 point.||||0.067
70892040|NCT03119766|141269883|SUPERIORITY|||||||0.029|||||||Fisher Exact|||Test for comparison percentage of patients with reduction ≥ 2 points.||||0.029
70892041|NCT03119766|141269883|SUPERIORITY|||||||0.082|||||||Fisher Exact|||Test for comparison percentage of patients with reduction ≥ 3 points.||||0.082
70892042|NCT03119766|141269883|SUPERIORITY|||||||0.046|||||||Fisher Exact|||Test for comparison percentage of patients with reduction ≥ 4 points.||||0.046
70892043|NCT03119766|141269883|SUPERIORITY|||||||0.111|||||||Fisher Exact|||Test for comparison percentage of patients with reduction ≥ 5 points.||||0.111
70892044|NCT03119766|141269884|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.435|TWO_SIDED|95.0|-0.93|2.15|||ANOVA||Results are presented as estimated differences of Least Squares Means according to ANOVA model|Mean changes of NDI scores after 8 weeks of treatment were compared.||2.15|-0.93|0.435
70892045|NCT03119766|141269885|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.655|TWO_SIDED|95.0|-2.0|1.26|||ANOVA||Results are presented as estimated differences of Least Squares Means according to ANOVA model|Mean changes of SF-36 scores (physical health domain) after 8 weeks of treatment were compared.||1.26|-2.00|0.655
70892046|NCT03119766|141269885|SUPERIORITY||Median Difference (Final Values)|0.65||||0.375|TWO_SIDED|95.0|-0.79|2.1|||ANOVA|||Mean changes of SF-36 scores (mental health domain) after 8 weeks of treatment were compared.||2.10|-0.79|0.375
70892047|NCT03119766|141269886|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
70892048|NCT03119766|141269887|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Side effects analysis.||||0.08
70892049|NCT03119766|141269887|SUPERIORITY|||||||0.139|||||||Wilcoxon (Mann-Whitney)|||Therapeutic effect||||0.139
70892050|NCT03119766|141269887|SUPERIORITY|||||||0.251|||||||Wilcoxon (Mann-Whitney)|||Efficacy index analysis.||||0.251
70892051|NCT02034578|141269890|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.953|||||TWO_SIDED|90.0|0.873|1.04||||||B versus A||1.040|0.873|
70892052|NCT02034578|141269890|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.805|||||TWO_SIDED|90.0|0.749|0.865||||||C versus A||0.865|0.749|
70892053|NCT02034578|141269892|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.966|||||TWO_SIDED|90.0|0.924|1.01||||||B versus A||1.010|0.924|
70892054|NCT02034578|141269892|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.919|||||TWO_SIDED|90.0|0.896|0.942||||||C versus A||0.942|0.896|
70892055|NCT02034578|141269893|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.968|||||TWO_SIDED|90.0|0.926|1.011||||||B versus A||1.011|0.926|
70892056|NCT02034578|141269893|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.922|||||TWO_SIDED|90.0|0.899|0.947||||||C versus A||0.947|0.899|
70892057|NCT00086346|141269943|SUPERIORITY_OR_OTHER|||||||0.342|||||||Rank ANCOVA|||||||0.342
70892058|NCT00086346|141269944|SUPERIORITY_OR_OTHER|||||||0.017|||||||Cochran-Mantel-Haenszel|||Comparison between treatment groups of percentages of patients with biopsy-confirmed acute rejection.||||0.017
70892059|NCT00086346|141269945|SUPERIORITY_OR_OTHER||||||>|0.05|||||||1 way ANOVA, two sided|||||||>0.05
70892060|NCT00086346|141269946|NON_INFERIORITY_OR_EQUIVALENCE|The a priori criterion for declaring non-inferiority was a lower bound of the 95% confidence interval (CI) having a ≥ 5% difference in graft loss. -5.2 is \< 5 % difference.|Mean Difference (Net)|-1.2||||||95.0|-5.2|2.8|||||Weighted difference in percentage of graft loss: (CNI% minus SRL%); negative values are favorable to CNI group|||2.8|-5.2|
70892061|NCT01055639|141269989|SUPERIORITY_OR_OTHER|||||||0.12|||||||t-test, 2 sided|||||||0.12
70892062|NCT01055639|141269990|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
70892063|NCT01055639|141269991|SUPERIORITY_OR_OTHER|||||||0.88|||||||t-test, 2 sided|||||||0.88
70892064|NCT01055639|141269992|SUPERIORITY_OR_OTHER|||||||0.48|||||||t-test, 2 sided|||||||0.48
70892065|NCT01055639|141269993|SUPERIORITY_OR_OTHER|||||||0.87|||||||t-test, 2 sided|||||||0.87
70892066|NCT01055639|141269994|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||||||0.29
70892067|NCT01055639|141269995|SUPERIORITY_OR_OTHER|||||||0.19|||||||t-test, 2 sided|||||||0.19
70892068|NCT01055639|141269996|SUPERIORITY_OR_OTHER|||||||0.53|||||||t-test, 2 sided|||||||0.53
70892069|NCT01055639|141269997|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||||||1.00
70892070|NCT00562159|141269998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31|||=|0.005|TWO_SIDED|95.0|-2.22|-0.4|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||-0.40|-2.22|=0.005
70892071|NCT00562159|141269999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86|||=|0.015|TWO_SIDED|95.0|-1.46|-0.26|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||-0.26|-1.46|=0.015
70892072|NCT00562159|141270000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|||=|0.084|TWO_SIDED|95.0|-0.96|0.06|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||0.06|-0.96|=0.084
70892073|NCT00562159|141270001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|||=|0.022|TWO_SIDED|95.0|-0.48|-0.05|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||-0.05|-0.48|=0.022
70892074|NCT02417246|141270002|EQUIVALENCE|A paired t-test was used to compare mean values of AUC0-24 for brand name metoprolol ER and Generic B at the 50mg dose. With a sample size of 38, at an alpha level of 0.025 (0.05/2 comparisons), using a 2-sided paired t test, we would have \>80% power to detect a 16% difference in AUC.|Mean Difference (Final Values)|45.1|STANDARD_DEVIATION|222.2||0.3|TWO_SIDED|95.0|-41.1|131.2|||t-test, 2 sided|Average AUC from 0 to 24 hours (0-24) for patients on the 50mg dose of brand name metoprolol ER and Generic B were compared by a paired t-test (n=28)||||131.2|-41.1|0.3
70892075|NCT02417246|141270002|EQUIVALENCE|A bioequivalence (BE) test was performed for patients who were administered the 50mg dose. BE was declared if 90% confidence interval for the ratio of the population geometric means of the AUC0-24 for Generic B to brand name metoprolol ER falls within 0.8 to 1.25|Geometric mean ratio|0.85|||||TWO_SIDED|90.0|0.76|0.95||The analysis included a total of 20 patients on Generic B and brand name metoprolol ER, which is less than the initial plan of including 38 patients.||||||0.95|0.76|
70892076|NCT02417246|141270002|EQUIVALENCE|A paired t-test was used to compare mean values of AUC0-24 for brand name metoprolol ER and Generic A at the 50mg dose. With a sample size of 38, at an alpha level of 0.025 (0.05/2 comparisons), using a 2-sided paired t test, we would have \>80% power to detect a 16% difference in AUC.|Mean Difference (Final Values)|7.2|STANDARD_DEVIATION|176.5||0.8|TWO_SIDED|95.0|-60.0|74.3|||t-test, 2 sided|Average AUC0-24 for patients on the 50mg dose who were administered brand name metoprolol ER and Generic A were compared using a paired t-test (n=29)||||74.3|-60.0|0.8
70892077|NCT02417246|141270002|EQUIVALENCE|A bioequivalence (BE) test was performed for patients who were administered the 50mg dose. BE was declared if the 90% confidence interval for the ratio of the population geometric means of the AUC0-24 for Generic A to brand name metoprolol ER fell within 0.8 to 1.25|Geometric mean ratio|0.93|||||TWO_SIDED|90.0|0.86|1.01||This analysis included 21 individuals who were administered brand name metoprolol ER and Generic A, which is less than the initial plan of including 38 patients.||||||1.01|0.86|
70892078|NCT02417246|141270003|EQUIVALENCE|A paired t-test was used to compare the mean values of Cmax for brand name metoprolol ER and Generic B at the 50mg dose. With a sample size of 38, at an alpha level of 0.025 (0.05/2 comparisons), using a 2-sided paired t-test, we would have \>80% power to detect a 11% difference in Cmax.|Mean Difference (Final Values)|2.6|STANDARD_DEVIATION|10.7||0.2|TWO_SIDED|95.0|-1.5|6.6|||t-test, 2 sided|Average Cmax for patients on the 50mg dose who were administered brand name metoprolol ER and Generic B were compared using a paired t-test (n=29)||||6.6|-1.5|0.2
70892079|NCT02417246|141270003|EQUIVALENCE|A bioequivalence (BE) test was performed for patients who were administered the 50mg dose. BE was declared if the 90% confidence interval for the ratio of the population geometric means of Cmax for Generic B to brand name metoprolol ER fell within 0.8 to 1.25|Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.79|0.95||The analysis included a total of 29 patients on Generic B and brand name metoprolol ER, which is less than the initial plan of including 38 patients||||||0.95|0.79|
70892080|NCT02417246|141270003|EQUIVALENCE|A paired t-test was used to compare the mean values of Cmax for brand name metoprolol ER and Generic A at the 50mg dose. With a sample size of 38, at an alpha level of 0.025 (0.05/2 comparisons), using a 2-sided paired t-test, we would have \>80% power to detect a 11% difference in Cmax.|Mean Difference (Final Values)|-2.5|STANDARD_DEVIATION|12.6||0.3|TWO_SIDED|95.0|-7.3|2.3|||t-test, 2 sided|Average Cmax for patients on the 50mg dose who were administered brand name metoprolol ER and Generic A were compared using a paired t-test (n=29)||||2.3|-7.3|0.3
70892081|NCT02417246|141270003|EQUIVALENCE|A bioequivalence (BE) test was performed for patients who were administered the 50mg dose. BE was declared if the 90% confidence interval for the ratio of the population geometric means of Cmax for Generic A to brand name metoprolol ER fell within 0.8 to 1.25|Geometric mean ratio|1.12|||||TWO_SIDED|90.0|1.02|1.23||The analysis included a total of 29 patients on Generic A and brand name metoprolol ER, which is less than a pre-planned sample size of 38.||||||1.23|1.02|
70892082|NCT02417246|141270004|EQUIVALENCE|A mixed effect model for repeated measures was used to model medication effect on HRV comparing brand name metoprolol ER to Generic B, adjusting for quartile, (quartile\*med) interaction, and treatment assignment.|Slope|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0858|TWO_SIDED||||||Mixed Models Analysis|||||||0.0858
70892083|NCT02417246|141270004|EQUIVALENCE|A mixed effect model for repeated measures was used to model medication effect on HRV comparing brand name metoprolol ER to Generic A, adjusting for quartile,(quartile\*med) interaction, and treatment assignment.|Slope|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.0168|TWO_SIDED||||||Mixed Models Analysis||p for medication\*quartile interaction considered significant if p\<0.025.|||||0.0168
70892084|NCT02417246|141270005|EQUIVALENCE|A mixed effect model for repeated measures was performed to model the 24-hour ambulatory systolic blood pressure (SBP) by quartile for 35 patients receiving brand name metoprolol ER and Generic B.|Slope|-2.39||||0.203|TWO_SIDED||||||Mixed Models Analysis|||||||0.203
70892085|NCT02417246|141270005|EQUIVALENCE|A mixed effect model for repeated measures was performed to model the 24-hour ambulatory diastolic blood pressure (DBP) by quartile for 35 patients receiving brand name metoprolol ER and Generic B.|Slope|-0.543||||0.671|TWO_SIDED||||||Mixed Models Analysis|||||||0.671
70892086|NCT02417246|141270005|EQUIVALENCE|A mixed effect model for repeated measures was performed to model the 24-hour ambulatory SBP by quartile for 35 patients receiving brand name metoprolol ER and Generic A.|Slope|-2.371||||0.2|TWO_SIDED||||||Mixed Models Analysis|||||||0.200
70892087|NCT02417246|141270005|EQUIVALENCE|A mixed effect model for repeated measures was performed to model the 24-hour ambulatory DBP by quartile for 35 patients receiving brand name metoprolol ER and Generic A.|Slope|-2.329||||0.068|TWO_SIDED||||||Mixed Models Analysis|||||||0.068
70892088|NCT02417246|141270006|EQUIVALENCE|A mixed effect model for repeated measures was performed to model the 24-hour HR by quartile for 35 patients receiving brand name metoprolol ER and Generic B.|Slope|1.233||||0.333|TWO_SIDED||||||Mixed Models Analysis|||||||0.333
70892089|NCT02417246|141270006|EQUIVALENCE|A mixed effect model for repeated measures was performed to model the 24-hour HR by quartile for 35 patients receiving brand name metoprolol ER and Generic A.|Slope|1.134||||0.368|TWO_SIDED||||||Mixed Models Analysis|||||||0.368
70892090|NCT01248884|141270015|NON_INFERIORITY|Non-inferiority in terms of immune response to diphteria antigens was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK2177744 Group 1) in the percentage of seroprotected subject was below or equal to 10%.|Difference in percentage|0.0|||||TWO_SIDED|97.5|-2.25|2.3||||||||2.3|-2.25|
70892091|NCT01248884|141270015|NON_INFERIORITY|Non-inferiority in terms of immune response to tetanus antigens was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK2177744 Group 1) in the percentage of seroprotected subject was below or equal to 10%.|Difference in percentage|0.0|||||TWO_SIDED|97.5|-2.25|2.3||||||||2.3|-2.25|
70892092|NCT01248884|141270015|NON_INFERIORITY|Non-inferiority in terms of immune response to diphteria antigens was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK2177744 Group 2) in the percentage of seroprotected subject was below or equal to 10%.|Difference in percentage|0.0|||||TWO_SIDED|97.5|-2.25|2.27||||||||2.27|-2.25|
70892093|NCT01248884|141270015|NON_INFERIORITY|Non-inferiority in terms of immune response to tetanus antigens was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK2177744 Group 2) in the percentage of seroprotected subject was below or equal to 10%.|Difference in percentage|0.0|||||TWO_SIDED|97.5|-2.25|2.27||||||||2.27|-2.25|
70892094|NCT01248884|141270017|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigen (anti-PT) was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the GMC ratio (Infanrix hexa Group divided by GSK2177744 Group 1) was below or equal to 1.5.|GMC ratio|1.26|||||TWO_SIDED|97.5|1.11|1.44||||||||1.44|1.11|
70892095|NCT01248884|141270017|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigen (anti-PRN) was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the GMC ratio (Infanrix hexa Group divided by GSK2177744 Group 1) was below or equal to 1.5.|GMC ratio|1.33|||||TWO_SIDED|97.5|1.14|1.54||||||||1.54|1.14|
70892096|NCT01248884|141270017|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigen (anti-PT) was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the GMC ratio (Infanrix hexa Group divided by GSK2177744 Group 2) was below or equal to 1.5.|GMC ratio|1.25|||||TWO_SIDED|97.5|1.1|1.43||||||||1.43|1.1|
70892097|NCT01248884|141270017|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigen (anti-PRN) was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the GMC ratio (Infanrix hexa Group divided by GSK2177744 Group 2) was below or equal to 1.5.|GMC ratio|1.58|||||TWO_SIDED|97.5|1.37|1.84||||||||1.84|1.37|
70892098|NCT01248884|141270018|NON_INFERIORITY|Non-inferiority in terms of immune response to PRP antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK217744 Group 1) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|-3.52|||||TWO_SIDED|97.5|-10.19|3.0||||||||3|-10.19|
70892099|NCT01248884|141270018|NON_INFERIORITY|Non-inferiority in terms of immune response to PRP antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK217744 Group 2) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|0.57|||||TWO_SIDED|97.5|-6.53|7.7||||||||7.7|-6.53|
70892100|NCT01248884|141270019|NON_INFERIORITY|Non-inferiority in terms of immune response to hepatitis B (HBs) antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa minus GSK217744 Group 1) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|0.56|||||TWO_SIDED|97.5|-3.27|4.63||||||Immune response non-inferiority - anti-HBs (ELISA)||4.63|-3.27|
70892101|NCT01248884|141270019|NON_INFERIORITY|Non-inferiority in terms of immune response to hepatitis B (HBs) antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa minus GSK217744 Group 2) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|-0.94|||||TWO_SIDED|97.5|-4.57|2.36||||||Immune response non-inferiority - anti-HBs (ELISA)||2.36|-4.57|
70892102|NCT01248884|141270019|NON_INFERIORITY|Non-inferiority in terms of immune response to hepatitis B (HBs) antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa minus GSK217744 Group 1) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|-0.4|||||TWO_SIDED|97.5|-4.62|3.8||||||Immune response non-inferiority - anti-HBs (CLIA)||3.8|-4.62|
70892103|NCT01248884|141270019|NON_INFERIORITY|Non-inferiority in terms of immune response to hepatitis B (HBs) antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa minus GSK217744 Group 2) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|-0.92|||||TWO_SIDED|97.5|-5.07|3.02||||||Immune response non-inferiority - anti-HBs (CLIA)||3.02|-5.07|
70892104|NCT04827212|141270076|SUPERIORITY||Mean Difference (Final Values)|0.31||||0.037|TWO_SIDED|||||P\<0.05|Mixed Models Analysis|||||||0.037
70892105|NCT04827212|141270077|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.78|TWO_SIDED|||||p-value is adjusted for multiple comparisons- P\<0.025; controlled for baseline values as there was a significant difference between groups at baseline|Mixed Models Analysis|||||||0.78
70892106|NCT04827212|141270078|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.56|TWO_SIDED|||||adjusted for multiple comparisons- P\<0.025; controlled for baseline value due to a significant difference between groups at baseline|Mixed Models Analysis|||||||0.56
70892107|NCT04827212|141270079|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.4|TWO_SIDED||||||Mixed Models Analysis|||||||0.4
70892108|NCT04827212|141270080|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.18|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.18
70892109|NCT04827212|141270081|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.86|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.86
70892110|NCT04827212|141270082|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.21|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.21
70892111|NCT04827212|141270083|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.19|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.19
70892112|NCT04827212|141270084|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.12|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.12
70892113|NCT04827212|141270085|SUPERIORITY||Mean Difference (Final Values)|6.2||||0.41|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.41
70892114|NCT04827212|141270086|SUPERIORITY||Mean Difference (Final Values)|6.2||||0.43|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.43
70892115|NCT04827212|141270087|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.53|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.53
70892116|NCT04827212|141270088|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.98|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.98
70892117|NCT04827212|141270089|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.96|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.96
70892118|NCT04827212|141270090|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.91|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.91
70892119|NCT04827212|141270091|SUPERIORITY||Mean Difference (Final Values)|13.1||||0.25|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.25
70892120|NCT04827212|141270092|SUPERIORITY||Mean Difference (Final Values)|8.5||||0.46|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.46
70892121|NCT04827212|141270093|SUPERIORITY||Mean Difference (Final Values)|9.6||||0.41|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.41
70892122|NCT04827212|141270094|SUPERIORITY||Mean Difference (Final Values)|-13.8||||0.12|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.12
70892123|NCT04827212|141270095|SUPERIORITY||Mean Difference (Final Values)|-11.9||||0.2|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.20
70892124|NCT04827212|141270096|SUPERIORITY||Mean Difference (Final Values)|-14.0||||0.13|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.13
70892125|NCT04827212|141270097|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.94|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.94
70892126|NCT04827212|141270098|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.72|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.72
70892127|NCT04827212|141270099|SUPERIORITY||Mean Difference (Final Values)|12.3||||0.33|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.33
70892128|NCT00320216|141270107|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi square test|Stratified by baseline weight \[\<=90kg vs \> 90 kg\].||||||<0.001
70892129|NCT00320216|141270107|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
70892130|NCT00320216|141270107|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
70892131|NCT00320216|141270107|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||To control for the multiplicity for the primary endpoint analysis, the 4 pairwise comparisons between ustekinumab groups and placebo were performed sequentially at alpha = 0.05. The order of testing was prespecified from high to low doses.|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||Null Hypothesis:No difference between any ustekinumab group and placebo at an overall significant level of 0.05. Sample Size: With 300 participants (60 in each treatment group), simulation studies were conducted to calculate the power to detect a treatment difference in primary endpoint between ustekinumab groups and placebo using a CMH test with stratification by baseline weight \[≤ 90kg vs \> 90 kg). For all the scenarios evaluated, the power is \>99% at an overall significance level of 0.05.||||<0.01
70892132|NCT00320216|141270108|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
70892133|NCT00320216|141270108|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
70892134|NCT00320216|141270108|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|||||||<0.001
70892135|NCT00320216|141270108|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||Null Hypothesis: No difference between any ustekinumab group and placebo.||||<0.001
70892136|NCT02265705|141270111|SUPERIORITY||Odds Ratio (OR)|4.1||||0.001|TWO_SIDED|95.0|2.5|6.9|||Regression, Logistic|||||6.9|2.5|0.001
70892137|NCT02265705|141270112|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.056||0.001|TWO_SIDED|95.0|-0.31|-0.09|||ANCOVA|||||-0.09|-0.31|0.001
70892138|NCT02265705|141270113|SUPERIORITY||Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.116||0.001|TWO_SIDED|95.0|-1.25|-0.79|||ANCOVA|||||-0.79|-1.25|0.001
70892139|NCT02265705|141270114|SUPERIORITY||Difference in response rate|1.4|||||TWO_SIDED|95.0|-0.5|3.3||||||||3.3|-0.5|
70892140|NCT02265705|141270115|SUPERIORITY||Median Difference (Final Values)|-12.9||||0.004|TWO_SIDED|95.0|-28.0|-2.9|||Wilcoxon (Mann-Whitney)|||||-2.9|-28.0|0.004
70892141|NCT02265705|141270116|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.23||0.002|TWO_SIDED|95.0|-1.2|-0.3|||ANCOVA|||||-0.3|-1.2|0.002
70892142|NCT02265705|141270117|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.2||0.001|TWO_SIDED|95.0|-1.2|-0.4|||ANCOVA|||||-0.4|-1.2|0.001
70892143|NCT02265705|141270118|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.2||0.001|TWO_SIDED|95.0|-1.3|-0.5|||ANCOVA|||||-0.5|-1.3|0.001
70892144|NCT00377676|141270123|NON_INFERIORITY_OR_EQUIVALENCE|In order to test the primary hypothesis at a one-sided alpha = .05 and have a power of 0.9, when the non-inferiority margin is 1.5, the total number of subjects with all-cause SAEs that must be observed during the study was found to be 235. Assuming the placebo rate is 0.08, the required sample size was found to be 2991.|Hazard Ratio (HR)|1.02|||<|0.05|ONE_SIDED|95.0||1.27||Using the Lan and Demets alpha spending function for O'Brien-Fleming boundaries and the overall one-sided significance level of 5%, a level of 0.04068 was to be used at the interim analysis and 0.03938 at the time of the final analysis.|Regression, Cox||cycloset to placebo|||1.27||<0.05
70892145|NCT00377676|141270124|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.58|||<|0.05|TWO_SIDED|95.0|0.35|0.96|||Regression, Cox|||In order to test the hypothesis for serious cardiovascular adverse events as for the primary endpoint at a one-sided alpha = 0.5 when the non-inferiority margin is 1.5, the final sample size of 3000 to 3300 subjects was to provide at least 62% power, assuming a hypothetical rate of events of 3.43%, or 103 to 113 cardiovascular SAEs. Upon demonstration of non-inferiority - a 2 sided using 95% CI was used to assess for superiority.||.96|.35|<0.05
70892146|NCT00377676|141270125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|1.4|<|0.001|||||||ANOVA|||If the standard deviation of HbA1c level is about 1.0% and the baseline and 24 week scores have a correlation of 0.50 then the effect size is 0.5%/1.0% = 0.50. For the metformin/SU analysis, 160 subjects assuming a standard deviation of 1.0% would provide a power of 90% power to detect differences in mean changes of 0.5% or larger.||||<0.001
70892147|NCT00377676|141270126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||<|0.001|||||||ANOVA|||||||<0.001
70892148|NCT00779246|141270129|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1|||>|0.05|TWO_SIDED|95.0|0.5|2.9|||Regression, Logistic|||Null hypothesis was that ASC and CHG would be no different in preventing acquisition of MRSA.||2.9|0.5|>0.05
70892149|NCT04153409|141270132|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Statistical comparisons of the 7 mean changes from baseline to different time-points (0-24 hours) were undertaken in one mixed effects model of analysis taking into account the cross-over nature of the study and the multiple time points within each period to explore a possible treatment effect in this small proof of concept study. Change from baseline at 0.5 hours is presented in this section|Mean Difference (Net)|-0.02||||0.9733|TWO_SIDED|95.0|-1.23|1.19||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 0.5 hours||1.19|-1.23|0.9733
70892150|NCT04153409|141270132|SUPERIORITY||Mean Difference (Net)|-0.42||||0.4942|TWO_SIDED|95.0|-1.64|0.79||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 1 hour. The change from baseline at 1 hour was extracted from the mixed model analysis including all time points.||0.79|-1.64|0.4942
70892151|NCT04153409|141270132|SUPERIORITY||Mean Difference (Net)|-0.25||||0.6866|TWO_SIDED|95.0|-1.46|0.97||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 1.5 hours. The change from baseline at 1.5 hours was extracted from the mixed model analysis including all time points.||0.97|-1.46|0.6866
70892152|NCT04153409|141270132|SUPERIORITY||Mean Difference (Net)|-0.89||||0.1488|TWO_SIDED|95.0|-2.11|0.32||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 2 hours. The change from baseline at 2 hours was extracted from the mixed model analysis including all time points.||0.32|-2.11|0.1488
70892153|NCT04153409|141270132|SUPERIORITY||Mean Difference (Net)|-0.36||||0.5644|TWO_SIDED|95.0|-1.57|0.86||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 4 hours. The change from baseline at 4 hours was extracted from the mixed model analysis including all time points.||0.86|-1.57|0.5644
70892154|NCT04153409|141270132|SUPERIORITY||Mean Difference (Net)|-0.7||||0.2561|TWO_SIDED|95.0|-1.91|0.51||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 8 hours, The change from baseline at 8 hours was extracted from the mixed model analysis including all time points.||0.51|-1.91|0.2561
70892155|NCT04153409|141270132|SUPERIORITY||Mean Difference (Net)|-0.01||||0.9875|TWO_SIDED|95.0|-1.22|1.2||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 24 hours. The change from baseline at 24 hours was extracted from the mixed model analysis including all time points.||1.20|-1.22|0.9875
70892156|NCT01592435|141270138|SUPERIORITY_OR_OTHER|||||||0.02||||||level of significance (alpha) = 0.05 All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits.|t-test, 1 sided|||||||0.02
70892157|NCT01592435|141270139|SUPERIORITY_OR_OTHER|||||||0||||||level of significance (alpha) = 0.05 All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits.|t-test, 1 sided|||||||0.00
70892158|NCT00941603|141270154|SUPERIORITY_OR_OTHER||Difference in percent|-3.5||||0.06|TWO_SIDED|95.0|-7.2|0.2|||ANOVA|Least-square (LS) means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||0.2|-7.2|0.06
70892159|NCT00941603|141270154|SUPERIORITY_OR_OTHER||Difference in percent|-3.1||||0.1|TWO_SIDED|95.0|-6.7|0.6||LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.|ANOVA|||||0.6|-6.7|0.10
70892160|NCT00941603|141270154|SUPERIORITY_OR_OTHER||Difference in percent|-5.7|||<|0.01|TWO_SIDED|95.0|-9.4|-2.0|||ANOVA|||LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||-2.0|-9.4|<0.01
70892161|NCT00941603|141270154|SUPERIORITY_OR_OTHER||Difference in percent|-1.3||||0.48|TWO_SIDED|95.0|-5.0|2.4|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||2.4|-5.0|0.48
70892162|NCT00941603|141270154|SUPERIORITY_OR_OTHER||Difference in percent|-0.4||||0.85|TWO_SIDED|95.0|-4.0|3.3|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||3.3|-4.0|0.85
70892163|NCT00941603|141270155|SUPERIORITY_OR_OTHER||Difference in percent|-3.0||||0.09|TWO_SIDED|95.0|-6.5|0.4|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||0.4|-6.5|0.09
70892164|NCT00941603|141270155|SUPERIORITY_OR_OTHER||Difference in percent|-3.6||||0.04|TWO_SIDED|95.0|-7.1|-0.2|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||-0.2|-7.1|0.04
70892165|NCT00941603|141270155|SUPERIORITY_OR_OTHER||Difference in percent|-4.4||||0.01|TWO_SIDED|95.0|-7.9|-1.0|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||-1.0|-7.9|0.01
70892166|NCT00941603|141270155|SUPERIORITY_OR_OTHER||Difference in percent|-1.4||||0.41|TWO_SIDED|95.0|-4.9|2.0|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||2.0|-4.9|0.41
70892167|NCT00941603|141270155|SUPERIORITY_OR_OTHER||Difference in percent|0.7||||0.68|TWO_SIDED|95.0|-2.7|4.2|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||4.2|-2.7|0.68
70892168|NCT00383435|141270173|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
70892169|NCT00383435|141270173|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||ANCOVA|||||||0.007
70892170|NCT00383435|141270174|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
70892171|NCT00383435|141270174|SUPERIORITY_OR_OTHER_LEGACY|||||||0.029|||||||ANCOVA|||||||0.029
70892172|NCT00383435|141270175|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||ANCOVA|||||||0.002
70892173|NCT00383435|141270175|SUPERIORITY_OR_OTHER_LEGACY|||||||0.059|||||||ANCOVA|||||||0.059
70892174|NCT03029208|141270284|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was greater than the pre-specified non-inferiority margin of -0.75 g/dL.|Least square (LS) mean difference|-0.1|||||TWO_SIDED|95.0|-0.34|0.14|||||An ANCOVA model including randomization stratification factors Baseline Hgb and treatment was performed to obtain a point estimate and two-sided 95% CI for the treatment difference (daprodustat-darbepoetin alfa).|||0.14|-0.34|
70892175|NCT03029208|141270285|SUPERIORITY||LS mean difference|19.4||||0.8949|TWO_SIDED|95.0|-11.0|49.9|||ANCOVA||An ANCOVA model was used to compare the difference in this average monthly IV iron dose between arms, including factors for Baseline dose, treatment and the randomization stratification factors.|||49.9|-11.0|0.8949
70892176|NCT03029208|141270286|SUPERIORITY||LS mean difference|3.23||||0.8168|TWO_SIDED|95.0|-3.82|10.27|||Mixed model repeated measures (MMRM)||The difference in change from Baseline in SBP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||10.27|-3.82|0.8168
70892177|NCT03029208|141270286|SUPERIORITY||LS mean difference|4.21||||0.9793|TWO_SIDED|95.0|0.17|8.26|||MMRM||The difference in change from Baseline in DBP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||8.26|0.17|0.9793
70892178|NCT03029208|141270286|SUPERIORITY||LS mean difference|4.1||||0.9597|TWO_SIDED|95.0|-0.51|8.7|||MMRM||The difference in change from Baseline in MAP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||8.70|-0.51|0.9597
70892179|NCT03029208|141270287|SUPERIORITY||LS mean difference|-0.09||||0.484|TWO_SIDED|95.0|-4.72|4.53|||ANCOVA||The difference in change from Baseline in SBP at the derived end of treatment was analyzed with an ANCOVA model including terms for treatment, prognostic randomization stratification factors.|||4.53|-4.72|0.4840
70892180|NCT03029208|141270287|SUPERIORITY||LS mean difference|1.99||||0.9156|TWO_SIDED|95.0|-0.85|4.82|||ANCOVA||The difference in change from Baseline in DBP at the derived end of treatment was analyzed with an ANCOVA model including terms for treatment, prognostic randomization stratification factors.|||4.82|-0.85|0.9156
70892181|NCT03029208|141270287|SUPERIORITY||LS mean difference|1.29||||0.7966|TWO_SIDED|95.0|-1.76|4.33|||ANCOVA||The difference in change from Baseline in MAP at the derived end of treatment was analyzed with an ANCOVA model including terms for treatment, prognostic randomization stratification factors.|||4.33|-1.76|0.7966
70892182|NCT03029208|141270288|SUPERIORITY||Ratio of exacerbation rate|1.01||||0.5174|TWO_SIDED|95.0|0.73|1.39|||Negative binomial model||Model estimated exacerbation rates, ratio of model estimated exacerbation rates and CIs were estimated using a negative binomial model for the treatment group comparison.|||1.39|0.73|0.5174
70892183|NCT03029208|141270290|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was greater than the pre-specified non-inferiority margin of -0.75 g/dL.|LS mean difference|0.04|||||TWO_SIDED|95.0|-0.29|0.36|||||The difference in change from Baseline in post-randomization Hgb at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||0.36|-0.29|
70892184|NCT03029208|141270291|SUPERIORITY||Difference in response rate|-0.8||||0.5411|TWO_SIDED|95.0|-12.2|10.7|||Cochran-Mantel-Haenszel||A Cochran-Mantel-Haenszel (CMH) test adjusted for treatment and randomization stratification factors were used to compare the number of responders between the treatment groups.|||10.7|-12.2|0.5411
70892185|NCT03029208|141270292|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% confidence interval for the treatment difference was greater than non-inferiority margin of -15%.|Median Difference (Final Values)|2.05|||||TWO_SIDED|95.0|-4.45|11.27|||||Hodges-Lehmann Estimate of Treatment Difference has been reported.|||11.27|-4.45|
70892186|NCT03029208|141270293|SUPERIORITY||Probability|0.54||||0.1538|TWO_SIDED|95.0|0.46|0.61|||van Elteren test||Mann-Whitney estimate (Probability) of the treatment effect has been presented.|||0.61|0.46|0.1538
70892187|NCT03029208|141270294|OTHER||Hazard Ratio (HR)|1.06||||0.5348|TWO_SIDED|95.0|0.31|3.66|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model adjusted for treatment group, dialysis type and dialysis start manner.|||3.66|0.31|0.5348
70892188|NCT03029208|141270295|SUPERIORITY||LS mean difference|-0.39||||0.6641|TWO_SIDED|95.0|-2.22|1.44|||MMRM||SF-36 HRQoL PCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||1.44|-2.22|0.6641
70892189|NCT03029208|141270295|SUPERIORITY||LS mean difference|1.13||||0.103|TWO_SIDED|95.0|-0.63|2.89|||MMRM||SF-36 HRQoL PCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||2.89|-0.63|0.1030
70892190|NCT03029208|141270295|SUPERIORITY||LS mean difference|0.49||||0.3157|TWO_SIDED|95.0|-1.51|2.48|||MMRM||SF-36 HRQoL PCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||2.48|-1.51|0.3157
70892191|NCT03029208|141270295|SUPERIORITY||LS mean difference|-1.31||||0.8855|TWO_SIDED|95.0|-3.46|0.84|||MMRM||SF-36 HRQoL PCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||0.84|-3.46|0.8855
70892192|NCT03029208|141270296|SUPERIORITY||LS mean difference|-0.67||||0.7146|TWO_SIDED|95.0|-2.99|1.66|||MMRM||SF-36 HRQoL MCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||1.66|-2.99|0.7146
70892193|NCT03029208|141270296|SUPERIORITY||LS mean difference|-1.53||||0.905|TWO_SIDED|95.0|-3.82|0.76|||MMRM||SF-36 HRQoL MCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||0.76|-3.82|0.9050
70892194|NCT03029208|141270296|SUPERIORITY||LS mean difference|-0.32||||0.595|TWO_SIDED|95.0|-2.91|2.28|||MMRM||SF-36 HRQoL MCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||2.28|-2.91|0.5950
70892195|NCT03029208|141270296|SUPERIORITY||LS mean difference|-0.23||||0.5619|TWO_SIDED|95.0|-3.17|2.7|||MMRM||SF-36 HRQoL MCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||2.70|-3.17|0.5619
70892196|NCT03029208|141270297|SUPERIORITY||LS mean difference|0.14||||0.4523|TWO_SIDED|95.0|-2.21|2.49|||MMRM||SF-36 HRQoL bodily pain domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||2.49|-2.21|0.4523
70892197|NCT03029208|141270297|SUPERIORITY||LS mean difference|-0.07||||0.5222|TWO_SIDED|95.0|-2.57|2.43|||MMRM||SF-36 HRQoL bodily pain domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||2.43|-2.57|0.5222
70892198|NCT03029208|141270297|SUPERIORITY||LS mean difference|2.33||||0.044|TWO_SIDED|95.0|-0.35|5.02|||MMRM||SF-36 HRQoL bodily pain domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||5.02|-0.35|0.0440
70892199|NCT03029208|141270297|SUPERIORITY||LS mean difference|-2.61||||0.9523|TWO_SIDED|95.0|-5.68|0.46|||MMRM||SF-36 HRQoL bodily pain domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||0.46|-5.68|0.9523
70892200|NCT03029208|141270297|SUPERIORITY||LS mean difference|0.05||||0.4811|TWO_SIDED|95.0|-1.82|1.91|||MMRM||SF-36 HRQoL general health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||1.91|-1.82|0.4811
70892201|NCT03029208|141270297|SUPERIORITY||LS mean difference|0.28||||0.3834|TWO_SIDED|95.0|-1.56|2.11|||MMRM||SF-36 HRQoL general health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||2.11|-1.56|0.3834
70892202|NCT03029208|141270297|SUPERIORITY||LS mean difference|0.26||||0.3983|TWO_SIDED|95.0|-1.72|2.24|||MMRM||SF-36 HRQoL general health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||2.24|-1.72|0.3983
70892203|NCT03029208|141270297|SUPERIORITY||LS mean difference|-0.18||||0.5617|TWO_SIDED|95.0|-2.51|2.15|||MMRM||SF-36 HRQoL general health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||2.15|-2.51|0.5617
70892204|NCT03029208|141270297|SUPERIORITY||LS mean difference|-1.15||||0.8336|TWO_SIDED|95.0|-3.48|1.18|||MMRM||SF-36 HRQoL mental health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||1.18|-3.48|0.8336
70892205|NCT03029208|141270297|SUPERIORITY||LS mean difference|-1.41||||0.9188|TWO_SIDED|95.0|-3.4|0.57|||MMRM||SF-36 HRQoL mental health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||0.57|-3.40|0.9188
70892206|NCT03029208|141270297|SUPERIORITY||LS mean difference|-0.48||||0.6495|TWO_SIDED|95.0|-2.96|1.99|||MMRM||SF-36 HRQoL mental health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||1.99|-2.96|0.6495
70892207|NCT03029208|141270297|SUPERIORITY||LS mean difference|-0.27||||0.5737|TWO_SIDED|95.0|-3.09|2.56|||MMRM||SF-36 HRQoL mental health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||2.56|-3.09|0.5737
70892208|NCT03029208|141270297|SUPERIORITY||LS mean difference|0.33||||0.3963|TWO_SIDED|95.0|-2.15|2.82|||MMRM||SF-36 HRQoL role-emotional domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||2.82|-2.15|0.3963
70892209|NCT03029208|141270297|SUPERIORITY||LS mean difference|0.62||||0.322|TWO_SIDED|95.0|-2.01|3.25|||MMRM||SF-36 HRQoL role-emotional domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||3.25|-2.01|0.3220
70892210|NCT03029208|141270297|SUPERIORITY||LS mean difference|0.53||||0.3485|TWO_SIDED|95.0|-2.13|3.18|||MMRM||SF-36 HRQoL role-emotional domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||3.18|-2.13|0.3485
70892211|NCT03029208|141270297|SUPERIORITY||LS mean difference|-1.49||||0.8064|TWO_SIDED|95.0|-4.87|1.9|||MMRM||SF-36 HRQoL role-emotional domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||1.90|-4.87|0.8064
70892212|NCT03029208|141270297|SUPERIORITY||LS mean difference|-1.29||||0.8687|TWO_SIDED|95.0|-3.57|0.98|||MMRM||SF-36 HRQoL role-physical domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||0.98|-3.57|0.8687
70892213|NCT03029208|141270297|SUPERIORITY||LS mean difference|0.71||||0.2435|TWO_SIDED|95.0|-1.29|2.7|||MMRM||SF-36 HRQoL role-physical domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||2.70|-1.29|0.2435
70892214|NCT03029208|141270297|SUPERIORITY||LS mean difference|-0.87||||0.7747|TWO_SIDED|95.0|-3.15|1.41|||MMRM||SF-36 HRQoL role-physical domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||1.41|-3.15|0.7747
70892215|NCT03029208|141270297|SUPERIORITY||LS mean difference|-0.73||||0.7141|TWO_SIDED|95.0|-3.26|1.81|||MMRM||SF-36 HRQoL role-physical domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||1.81|-3.26|0.7141
70892216|NCT03029208|141270297|SUPERIORITY||LS mean difference|-1.03||||0.7803|TWO_SIDED|95.0|-3.65|1.59|||MMRM||SF-36 HRQoL social functioning domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||1.59|-3.65|0.7803
70892217|NCT03029208|141270297|SUPERIORITY||LS mean difference|-1.18||||0.8556|TWO_SIDED|95.0|-3.35|1.0|||MMRM||SF-36 HRQoL social functioning domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||1.00|-3.35|0.8556
70892218|NCT03029208|141270297|SUPERIORITY||LS mean difference|0.08||||0.4763|TWO_SIDED|95.0|-2.61|2.77|||MMRM||SF-36 HRQoL social functioning domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||2.77|-2.61|0.4763
70892219|NCT03029208|141270297|SUPERIORITY||LS mean difference|0.73||||0.3208|TWO_SIDED|95.0|-2.35|3.8|||MMRM||SF-36 HRQoL social functioning domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||3.80|-2.35|0.3208
70892220|NCT03029208|141270298|SUPERIORITY||LS mean difference|-1.02||||0.791|TWO_SIDED|95.0|-3.5|1.46|||MMRM||SF-36 HRQoL vitality domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||1.46|-3.50|0.7910
70892221|NCT03029208|141270298|SUPERIORITY||LS mean difference|-1.45||||0.8648|TWO_SIDED|95.0|-4.03|1.14|||MMRM||SF-36 HRQoL vitality domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||1.14|-4.03|0.8648
70892222|NCT03029208|141270299|SUPERIORITY||LS mean difference|-0.28||||0.5879|TWO_SIDED|95.0|-2.75|2.19|||MMRM||SF-36 HRQoL physical functioning domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||2.19|-2.75|0.5879
70892223|NCT03029208|141270299|SUPERIORITY||LS mean difference|-1.43||||0.8525|TWO_SIDED|95.0|-4.12|1.26|||MMRM||SF-36 HRQoL physical functioning domain scor was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||1.26|-4.12|0.8525
70892224|NCT03029208|141270300|SUPERIORITY||LS mean difference|0.03||||0.3154|TWO_SIDED|95.0|-0.09|0.14|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.14|-0.09|0.3154
70892225|NCT03029208|141270301|SUPERIORITY||LS mean difference|-3.4||||0.7651|TWO_SIDED|95.0|-12.7|5.9|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||5.9|-12.7|0.7651
70892226|NCT03029208|141270302|SUPERIORITY||LS mean difference|-6.43||||0.9875|TWO_SIDED|95.0|-12.05|-0.82|||MMRM||Tired/Low energy/Weak domain: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||-0.82|-12.05|0.9875
70892227|NCT03029208|141270302|SUPERIORITY||LS mean difference|-4.11||||0.9663|TWO_SIDED|95.0|-8.52|0.3|||MMRM||Chest pain/Shortness of breath domain: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.30|-8.52|0.9663
70892228|NCT03029208|141270302|SUPERIORITY||LS mean difference|-6.6||||0.993|TWO_SIDED|95.0|-11.84|-1.35|||MMRM||Cognitive domain: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||-1.35|-11.84|0.9930
70892229|NCT03029208|141270302|SUPERIORITY||LS mean difference|-3.03||||0.8765|TWO_SIDED|95.0|-8.19|2.12|||MMRM||Shortness of breath, no activity: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||2.12|-8.19|0.8765
70892230|NCT03029208|141270302|SUPERIORITY||LS mean difference|-4.27||||0.9464|TWO_SIDED|95.0|-9.48|0.94|||MMRM||Severity-short breath, Resting: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.94|-9.48|0.9464
70892231|NCT03029208|141270302|SUPERIORITY||LS mean difference|-5.31||||0.9101|TWO_SIDED|95.0|-13.09|2.47|||MMRM||Difficulty standing for long time: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||2.47|-13.09|0.9101
70892232|NCT03029208|141270302|SUPERIORITY||LS mean difference|-6.52||||0.9586|TWO_SIDED|95.0|-13.9|0.86|||MMRM||Difficulty sleeping: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.86|-13.90|0.9586
70892233|NCT03029208|141270303|SUPERIORITY||LS mean difference|0.27||||0.981|TWO_SIDED|95.0|0.02|0.53|||MMRM||MMRM model was fitted from Baseline up to Week 8 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.53|0.02|0.9810
70892234|NCT03029208|141270303|SUPERIORITY||LS mean difference|0.05||||0.6743|TWO_SIDED|95.0|-0.17|0.26|||MMRM||MMRM model was fitted from Baseline up to Week 12 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.26|-0.17|0.6743
70892235|NCT03029208|141270303|SUPERIORITY||LS mean difference|0.16||||0.8997|TWO_SIDED|95.0|-0.09|0.4|||MMRM||MMRM model was fitted from Baseline up to Week 28 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.40|-0.09|0.8997
70892236|NCT03029208|141270303|SUPERIORITY||LS mean difference|0.18||||0.8835|TWO_SIDED|95.0|-0.12|0.47|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.47|-0.12|0.8835
70892237|NCT03965052|141270350|OTHER|||||||1|||||||Fisher Exact|||||||1.000
70892238|NCT03965052|141270352|OTHER|||||||1|||||||Fisher Exact|||Lissamine green treatment groups||||1.000
70892239|NCT03965052|141270352|OTHER|||||||0.667|||||||Fisher Exact|||Fluorescein treatment groups||||0.667
70892240|NCT03965052|141270353|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
70892241|NCT03965052|141270354|OTHER|||||||0.977|||||||Chi-squared, Corrected|||the analysis was per protocol||||0.977
70892242|NCT03965052|141270356|OTHER|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||||||0.019
70892243|NCT01910519|141270378|OTHER|||||||0.0039|||||||ANOVA|||Correlation of vaccine-induced blood transcription modules (BTMs) M183-TBA at day 1 with MN titers at day 42||||0.0039
70892244|NCT01910519|141270378|OTHER|||||||0.0368|||||||ANOVA|||Correlation of vaccine-induced blood transcription modules (BTMs) M115-cytokines-receptors cluster at day 1 with MN titers at day 42||||0.0368
70892245|NCT01910519|141270378|OTHER|||||||0.0465|||||||ANOVA|||Correlation of vaccine-induced blood transcription modules (BTMs) M74-transcriptional targets of glucocorticoid receptor at day 1 with MN titers at day 42||||0.0465
70892246|NCT01910519|141270378|OTHER|||||||0.0411|||||||ANOVA|||Correlation of vaccine-induced blood transcription modules (BTMs) M58-B cell development/activation at day 1 with MN titers at day 42||||0.0411
70892247|NCT01910519|141270378|OTHER|||||||0.0067|||||||ANOVA|||Correlation of vaccine-induced blood transcription modules (BTMs) M114.0-TBA at day 1 with MN titers at day 42||||0.0067
70892248|NCT04266028|141270379|OTHER|No statistical analyses were performed.|no statistical analyses were performed|0.0|||||TWO_SIDED|||||No statistical analyses were performed||||No statistical analyses were performed.|No statistical analyses were performed.|||
70892249|NCT00566228|141270432|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.69|TWO_SIDED|95.0|0.62|2.08|||Log Rank|||||2.08|0.62|0.690
70892250|NCT00566228|141270435|SUPERIORITY|||||||0.679|||||||Log Rank|||||||0.679
70892251|NCT03521635|141270439|OTHER||Adjusted mean difference|0.7|STANDARD_ERROR_OF_MEAN|1.68||0.688|TWO_SIDED|95.0|-2.7|4.0|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release|Mean changes from baseline of PDSS-2 score were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||4.0|-2.7|0.688
70892252|NCT03521635|141270440|OTHER||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.51||0.69|TWO_SIDED|95.0|-1.2|0.8|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of NHQ score by patients were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||0.8|-1.2|0.690
70892253|NCT03521635|141270440|OTHER||Adjusted mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.91||0.376|TWO_SIDED|95.0|-2.7|1.1|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of NHQ score by caregivers were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||1.1|-2.7|0.376
70892254|NCT03521635|141270441|OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.66||0.333|TWO_SIDED|95.0|-1.9|0.7|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of SCOPA-Sleep night-time sleep score were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||0.7|-1.9|0.333
70892255|NCT03521635|141270441|OTHER||Adjusted mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.29||0.374|TWO_SIDED|95.0|-0.8|0.3|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of SCOPA-Sleep overall night sleep score were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||0.3|-0.8|0.374
70892256|NCT03521635|141270441|OTHER||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.49||0.352|TWO_SIDED|95.0|-1.4|0.5|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of SCOPA-Sleep daytime sleepiness score were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||0.5|-1.4|0.352
70892257|NCT03521635|141270442|OTHER||Adjusted mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.26||0.259|TWO_SIDED|95.0|-0.8|0.2|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of EMO sore were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||0.2|-0.8|0.259
70892258|NCT03521635|141270443|OTHER||Odds Ratio (OR)|0.96||||0.9373|TWO_SIDED|95.0|0.36|2.54|||Regression, Logistic||The odds ratio (OR) between Pramipexole Sustained Release and Pramipexole Immediate Release groups.|Logistic regression analyses for responder rate at week 18 of PDSS-2 score \<18 were performed with treatment and baseline as the independent variables.||2.54|0.36|0.9373
70892259|NCT03521635|141270444|OTHER||Odds Ratio (OR)|2.24||||0.1611|TWO_SIDED|95.0|0.73|7.49|||Regression, Logistic||The odds ratio (OR) between Pramipexole Sustained Release and Pramipexole Immediate Release groups.|Logistic regression analyses for responder rate at week 18 of EMO score were performed with treatment and baseline as the independent variables.||7.49|0.73|0.1611
70892260|NCT03521635|141270445|OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.87||0.517|TWO_SIDED|95.0|-2.3|1.2|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of PDQ-8 score were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||1.2|-2.3|0.517
70892261|NCT03521635|141270446|OTHER||Odds Ratio (OR)|3.44||||0.2374|TWO_SIDED|95.0|0.57|36.85|||Regression, Logistic||The odds ratio (OR) between Pramipexole Sustained Release and Pramipexole Immediate Release groups.|Logistic regression analyses for responder rate at week 18 of CGI-I were performed with treatment as the independent variable.||36.85|0.57|0.2374
70892262|NCT03521635|141270447|OTHER||Odds Ratio (OR)|3.44||||0.2374|TWO_SIDED|95.0|0.57|36.85|||Regression, Logistic||The odds ratio (OR) between Pramipexole Sustained Release and Pramipexole Immediate Release groups.|Logistic regression analyses for responder rate at week 18 of PGI-I were performed with treatment as the independent variable.||36.85|0.57|0.2374
70892263|NCT03521635|141270448|OTHER||Adjusted mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.79||0.82|TWO_SIDED|95.0|-1.4|1.7|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of ESS score were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||1.7|-1.4|0.820
70892264|NCT00414700|141270452|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANCOVA|Adjusted for age, associated lesion(s) and location of lesion||Test for superiority||||0.003
70892265|NCT00414700|141270453|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANCOVA|Adjusted for age, associated lesion(s) and location of lesion.||Test for superiority||||0.010
70892266|NCT00414700|141270454|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -9 % points|Mean Difference (Final Values)|1.81|STANDARD_ERROR_OF_MEAN|2.4||||95.0|-3.28|6.9|||ANCOVA|Adjusted for baseline Overall KOOS score, age, associated lesion(s) and location of lesion.||||6.90|-3.28|
70892267|NCT01659021|141270469|SUPERIORITY||Hazard Ratio (HR)|0.26|||<|0.0001|TWO_SIDED|95.0|0.18|0.37||P-value is from stratified log-rank test, adjusted for randomization stratification factors (17p deletion/TP53 mutation, immunoglobulin heavy chain variable region (IGHV) mutation, and disease status).|Log Rank||Hazard Ratio and 95% confidence intervals (CI) are from the proportional hazard model, adjusted for randomization stratification factors.|||0.37|0.18|<0.0001
70892268|NCT01659021|141270470|SUPERIORITY||Odds Ratio (OR)|16.85|||<|0.0001|TWO_SIDED|95.0|8.17|34.76||P-value was calculated from the Cochran-Mantel-Haenszel (CMH) Chi-square test stratified by stratification factors.|Cochran-Mantel-Haenszel||Odds ratio and 95% CIs were calculated from the CMH Chi-square test stratified by stratification factors.|||34.76|8.17|<0.0001
70892269|NCT01659021|141270471|SUPERIORITY||Odds Ratio (OR)|483.16|||<|0.0001|TWO_SIDED|95.0|94.63|2467.02||P-value was calculated from the CMH Chi-square test stratified by stratification factors.|Cochran-Mantel-Haenszel||Odds ratio and 95% CIs were calculated from the CMH Chi-square test stratified by stratification factors.|||2467.02|94.63|<0.0001
70892270|NCT01659021|141270472|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.247|TWO_SIDED|95.0|0.54|1.15||P-value is from stratified log-rank test, adjusted for randomization stratification factors (17p deletion/TP53 mutation, IGHV mutation, and disease status).|Log Rank|||||1.15|0.54|0.247
70892271|NCT01659021|141270473|OTHER||Hazard Ratio (HR)|0.3|||||TWO_SIDED|95.0|0.17|0.51|||||Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model without any adjustments.|||0.51|0.17|
70892272|NCT01169467|141270497|SUPERIORITY_OR_OTHER|||||||0.395|TWO_SIDED||||||t-test, 2 sided|||||||0.395
70892273|NCT03108924|141270506|OTHER||GMR|0.77|||||TWO_SIDED|90.0|0.53|1.13||||Categorical Analysis|GMR = GM for ESRD HD / GM for ESRD Non-HD|||1.13|0.53|
70892274|NCT03108924|141270509|OTHER||GMR|2.98|||||TWO_SIDED|90.0|2.01|4.41||||Categorical Analysis|GMR = GM for Moderate RI / GM for Healthy Controls|||4.41|2.01|
70892275|NCT03108924|141270509|OTHER||GMR|4.43|||||TWO_SIDED|95.0|2.82|6.96||||Categorical Analysis|GMR = GM for Severe RI / GM for Healthy Controls|||6.96|2.82|
70892276|NCT03108924|141270509|OTHER||GMR|4.74|||||TWO_SIDED|90.0|2.95|7.59||||Categorical Analysis|GMR = GM for ESRD HD / GM for Healthy Controls|||7.59|2.95|
70892277|NCT03108924|141270511|OTHER||GMR|0.77|||||TWO_SIDED|90.0|0.54|1.08||||Categorical Analysis|GMR = GM for ESRD HD / GM for ESRD Non-HD|||1.08|0.54|
70892278|NCT03108924|141270514|OTHER||GMR|3.23|||||TWO_SIDED|90.0|2.01|5.2||||Categorical Analysis|GMR = GM for Moderate RI / GM for Healthy Controls|||5.20|2.01|
70892279|NCT03108924|141270514|OTHER||GMR|4.08|||||TWO_SIDED|90.0|2.49|6.7||||Categorical Analysis|GMR = GM for Severe RI / GM for Healthy Controls|||6.70|2.49|
70892280|NCT03108924|141270514|OTHER||GMR|4.43|||||TWO_SIDED|90.0|2.65|7.39||||Categorical Analysis|GMR = GM for ESRD Non-HD / GM for Healthy Controls|||7.39|2.65|
70892281|NCT03108924|141270516|OTHER||GMR|0.73|||||TWO_SIDED|90.0|0.52|1.03||||Categorical Analysis|GMR = GM for ESRD HD / GM for ESRD Non-HD|||1.03|0.52|
70892282|NCT03108924|141270519|OTHER||GMR|2.09|||||TWO_SIDED|90.0|1.22|3.56||||Categorical Analysis|GMR = GM for Moderate RI / GM for Healthy Controls|||3.56|1.22|
70892283|NCT03108924|141270519|OTHER||GMR|1.89|||||TWO_SIDED|95.0|1.1|3.25||||Categorical Analysis|GMR = GM for Severe RI / GM for Healthy Controls|||3.25|1.10|
70892284|NCT03108924|141270519|OTHER||GMR|1.9|||||TWO_SIDED|90.0|1.13|3.19||||Categorical Analysis|GMR = GM for ESRD Non-HD / GM for Healthy Controls|||3.19|1.13|
70892285|NCT03108924|141270521|OTHER||GMR|1.3|||||TWO_SIDED|90.0|0.88|1.9||||Categorical Analysis|GMR = GM for ESRD / GM for ESRD Non-HD|||1.90|0.88|
70892286|NCT03108924|141270524|OTHER||GMR|0.34|||||TWO_SIDED|95.0|0.23|0.5||||Categorical Analysis|GMR = GM for Moderate RI / GM for Healthy Controls|||0.50|0.23|
70892287|NCT03108924|141270524|OTHER||GMR|0.23|||||TWO_SIDED|95.0|0.14|0.35||||Categorical Analysis|GMR = GM for Severe RI / GM for Healthy Controls|||0.35|0.14|
70892288|NCT03108924|141270524|OTHER||GMR|0.21|||||TWO_SIDED|95.0|0.13|0.34||||Categorical Analysis|GMR = GM for ESRD Non-HD / GM for Healthy Controls|||0.34|0.13|
70892289|NCT03108924|141270526|OTHER||GMR|0.31|||||TWO_SIDED|90.0|0.25|0.39||||Categorical Analysis|GMR = GM for Moderate RI / GM for Healthy Controls|||0.39|0.25|
70892290|NCT03108924|141270526|OTHER||GMR|0.1|||||TWO_SIDED|90.0|0.07|0.16||||Categorical Analysis|GMR = GM for Severe RI / GM for Healthy Controls|||0.16|0.07|
70892291|NCT00924885|141270550|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||The primary end-point was the 'overall pain experience', evaluated as described previously. Assuming the mean overall pain in the RN group to be 27 mm (value chosen after analysis of data from a previous study, Cerne et al., 2006) on VAS, with a standard deviation (SD) of 21.5 mm, 121 patients in each group would be needed to demonstrate a decrease in overall pain of 8 mm (30%) with 80% power and a significance level of 0.05 (two-tailed tests).||||0.04
70892292|NCT00784810|141270552|NON_INFERIORITY_OR_EQUIVALENCE|As above.|Mean Difference (Net)|0.44|STANDARD_ERROR_OF_MEAN|1.19||0.002|ONE_SIDED|90.0|-5.65||||Mixed Models Analysis|||To achieve a study with 80% power at the 1-sided 5% significance level, for the purposes of demonstrating non inferiority, a sample size of 98 subjects per treatment group was required, i.e. a total of 196 subjects completing the study.|||-5.65|0.002
70892293|NCT02508480|141270563|SUPERIORITY|||||||0.66|||||||Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction. The p-value reported below is for group effect.||||0.66
70892294|NCT02508480|141270564|SUPERIORITY|||||||0.884||||||Group effect for Proactive Coping|Mixed Models Analysis|||"The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.~The p-value reported below is for group effect for Proactive Coping."||||0.884
70892295|NCT02508480|141270564|SUPERIORITY|||||||0.543||||||Group effect for Avoidant Coping.|Mixed Models Analysis|||"The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.~The p-value reported below is for group effect for Avoidant Coping."||||0.543
70892296|NCT02508480|141270565|SUPERIORITY|||||||0.135||||||The p-value above is for the overall group effect.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.135
70892297|NCT02508480|141270566|SUPERIORITY|||||||0.25||||||The p-value above represents the overall group effect.|Mixed Models Analysis|||The two study arms were compared on the interpersonal function subscale using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.25
70892298|NCT02508480|141270566|SUPERIORITY|||||||0.118||||||The p-value represents the overall group effect.|Mixed Models Analysis|||The two study arms were compared on the intrapsychic foundations subscale using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.118
70892299|NCT02508480|141270567|SUPERIORITY|||||||0.917||||||The p-value is for group effect for tcpm\_days\_participated.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction. The p-value reported below is for group effect for tcpm\_days\_participated.||||0.917
70892300|NCT02508480|141270568|SUPERIORITY|||||||0.017||||||The p-value above is for the overall group effect.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.017
70892301|NCT02508480|141270569|SUPERIORITY|||||||0.597||||||The p-value above represents the overall group effect.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.597
70892302|NCT02508480|141270570|SUPERIORITY|||||||0.076||||||The p-value above represents the overall group effect.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.076
70892303|NCT02508480|141270571|SUPERIORITY|||||||0.978||||||The p-value above represents the overall group effect.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.978
70892304|NCT00304070|141270599|OTHER||2 Year EFS|0.89||||0.44|TWO_SIDED|95.0|||||2-year KM estimate|||We will test the 2-year EFS is 90% using the asymptotic distribution of the complementary log-log distribution of the Kaplan-Meier (KM) estimate.||||0.44
70892305|NCT00304070|141270599|OTHER||2 Year EFS|0.53||||0.4|TWO_SIDED|95.0|||||2-year KM estimate|||We will test the 2-year EFS is 50% using the asymptotic distribution of the complementary log-log distribution of the Kaplan-Meier (KM) estimate.||||0.40
70892306|NCT00304070|141270599|OTHER||2 Year EFS|0.55||||8.53e-06|TWO_SIDED|95.0|||||2-year KM estimate|||We will test the 2-year EFS is 15% using the asymptotic distribution of the complementary log-log distribution of the Kaplan-Meier (KM) estimate.||||0.00000853
70892307|NCT03579459|141270606|EQUIVALENCE|Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).|Geometric Mean ratio (GMR)|1.01|||||TWO_SIDED|95.0|0.86|1.18|||||Confidence intervals (CIs) were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations|Toxin A||1.18|0.86|
70892308|NCT03579459|141270606|EQUIVALENCE|Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).|GMR|1.01|||||TWO_SIDED|95.0|0.86|1.18|||||CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations|Toxin A||1.18|0.86|
70892309|NCT03579459|141270606|EQUIVALENCE|Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).|GMR|1.0|||||TWO_SIDED|95.0|0.85|1.17|||||CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations|Toxin A||1.17|0.85|
70892310|NCT03579459|141270606|EQUIVALENCE|Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).|GMR|1.07|||||TWO_SIDED|95.0|0.87|1.31|||||CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations|Toxin B||1.31|0.87|
70892311|NCT03579459|141270606|EQUIVALENCE|Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).|GMR|1.07|||||TWO_SIDED|95.0|0.88|1.31|||||CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations|Toxin B||1.31|0.88|
70892312|NCT03579459|141270606|EQUIVALENCE|Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).|GMR|1.01|||||TWO_SIDED|95.0|0.83|1.23|||||CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations|Toxin B||1.23|0.83|
70892313|NCT00148343|141270615|SUPERIORITY_OR_OTHER||Slope|1.26|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-0.2|2.75|||||Mixed model analysis. Slope is in reference to treatment x time interaction for full 36 weeks|||2.75|-0.2|
70892314|NCT00148343|141270616|SUPERIORITY||Slope|-5.07|STANDARD_ERROR_OF_MEAN|2.54|<|0.05|TWO_SIDED|95.0|-10.05|-0.09|||Mixed Models Analysis||Slope is in reference to from baseline to end of follow-up at 36 weeks.|||-0.09|-10.05|<0.05
70892315|NCT00148343|141270617|SUPERIORITY_OR_OTHER||Slope|0.31|STANDARD_ERROR_OF_MEAN|7.35|<|0.05|TWO_SIDED|95.0|-14.096|14.716|||Mixed Models Analysis||Slope is in reference to start of treatment to end of follow up at 36 weeks|||14.716|-14.096|<0.05
70892316|NCT00148343|141270618|SUPERIORITY||Slope|-1.95|STANDARD_ERROR_OF_MEAN|5.53|||TWO_SIDED|95.0|-12.79|8.89|||||Mixed models analysis. Slope refers to baseline to final follow up at 36 weeks|||8.89|-12.79|
70892317|NCT00148343|141270619|SUPERIORITY||Slope|0.006|STANDARD_ERROR_OF_MEAN|0.026|<|0.05|TWO_SIDED|95.0|-0.045|0.057|||Mixed Models Analysis||Slope is in reference to baseline to end of follow-up at 36 weeks|||0.057|-0.045|<0.05
70963583|NCT03531788|141432067|OTHER|||||||||||||||||Three goals were identified for each participant and scored without using an arm support device to serve as a baseline measure of abilities. These scores were compared to the scores achieved on the same goals using the arm support device.|We compared the change in GAS scores when using an arm support device on three goal areas identified as important for each participant. For each goal, we measured abilities at baseline and with the device (Kinova and WREX). We calculated the change in score for each goal and averaged these change scores across all participants. While our groups are too small to complete statistical tests to estimate the significance of the differences participants noted in activity and independence while using both arm supports, our results quantify the amount of increased success participants noted with the use of the arm support device.|||
70892318|NCT02528214|141270641|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.|Least Square (LS) Mean Difference|28.24|||<|0.0001|TWO_SIDED|95.0|15.81|40.67||Threshold for significance at two-sided 0.05 level.|ANCOVA||LS mean difference represents reduction difference i.e. dupilumab - placebo.|The outcome measure was analyzed using analysis of covariance (ANCOVA) model which included percentage reduction of OCS dose at Week 24 as the response variable, and treatment group, baseline eosinophil level, optimized OCS dose at baseline, region as covariates. Missing data was imputed using a pattern mixture model by multiple imputation approach.||40.67|15.81|< 0.0001
70892319|NCT02528214|141270643|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).|Odds Ratio (OR)|3.98|||<|0.0001|TWO_SIDED|95.0|2.06|7.67||Threshold for significance at 0.05.|Regression, Logistic||Dupilumab 300 mg q2w v Placebo q2w|The outcome measure was analyzed using a logistic regression model. The model included the binary status of whether or not a participant achieved the 50% OCS dose reduction criterion as the response variable, and treatment groups, optimized OCS dose at baseline, regions, and baseline eosinophil level subgroups as covariates. Missing data was imputed by using a pattern mixture model by multiple imputation approach.||7.67|2.06|< 0.0001
70892320|NCT02528214|141270644|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).|Odds Ratio (OR)|4.48|||<|0.0001|TWO_SIDED|95.0|2.39|8.39||Threshold for significance at 0.05.|Regression, Logistic||Dupilumab 300 mg q2w v Placebo q2w|The outcome measure was analyzed using a logistic regression model. The model included the binary status of whether or not a participant achieved a reduction of OCS dose to \<5 mg/day at Week 24 as the response variable, treatment groups, optimized OCS dose at baseline, regions, and baseline eosinophil level subgroups as covariates. Missing data was imputed by using a pattern mixture model by multiple imputation approach.||8.39|2.39|< 0.0001
70892321|NCT02528214|141270645|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).|Odds Ratio (OR)|2.57||||0.0024|TWO_SIDED|95.0|1.4|4.73||Threshold for significance at 0.05.|Regression, Logistic||Dupilumab 300 mg q2w v Placebo q2w|The outcome was analyzed using a logistic regression model. The model included binary status of whether or not a participant achieved their maximum possible reduction of OCS dose per protocol at Week 24 as the response variable, treatment groups, optimized OCS dose at baseline, regions, and baseline eosinophil level subgroups as covariates. Missing data was imputed by using a pattern mixture model by multiple imputation approach.||4.73|1.4|0.0024
70892322|NCT02528214|141270646|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).|Odds Ratio (OR)|2.74||||0.0015|TWO_SIDED|95.0|1.47|5.1||Threshold for significance at 0.05.|Regression, Logistic||Dupilumab 300 mg q2w v Placebo q2w|The outcome measure was analyzed using a logistic regression model. The model included the binary status of whether or not a participant no longer required OCS at Week 24 as the response variable, and treatment groups, optimized OCS dose at baseline, regions, and baseline eosinophil level subgroups as covariates. Missing data was imputed using a pattern mixture model by multiple imputation approach.||5.1|1.47|0.0015
70892323|NCT03447769|141270656|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.258|TWO_SIDED|95.0|0.78|1.14||1-sided p-value|Stratified log-rank test||The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test.|||1.14|0.78|0.258
70892324|NCT03447769|141270661|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.676|TWO_SIDED|95.0|0.76|1.58||1-sided p-value|Stratified log-rank test||The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test|PD-L1 \<1%||1.58|0.76|0.676
70892325|NCT03447769|141270661|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.036|TWO_SIDED|95.0|0.34|1.05||1-sided p-value|Stratified log-rank test||The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test|PD-L1 ≥1% and \<49%||1.05|0.34|0.036
70892326|NCT03447769|141270661|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.823|TWO_SIDED|95.0|0.73|2.43||1-sided p-value|Stratified log-rank test||The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test|PD-L1 ≥50%||2.43|0.73|0.823
70892327|NCT03447769|141270662|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.872|TWO_SIDED|95.0|0.87|1.72||1-sided p-value|Stratified log-rank test||The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test.|CD8 \< median||1.72|0.87|0.872
70892328|NCT03447769|141270662|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.303|TWO_SIDED|95.0|0.62|1.33||1-sided p-value|Stratified log-rank test||The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test.|CD8 ≥ median||1.33|0.62|0.303
70892329|NCT01343407|141270672|OTHER||Difference in Least Squares Means (LSM)|-22.2||||0.011|TWO_SIDED|90.0|-35.7|-8.7|||Linear mixed effects model|||||-8.7|-35.7|0.011
70892330|NCT01343407|141270672|OTHER||Difference in LSM|-18.9||||0.023|TWO_SIDED|90.0|-32.1|-5.8|||Linear mixed effects model|||||-5.8|-32.1|0.023
70892331|NCT01343407|141270673|OTHER||LS Mean Ratio (LSMR)|0.48||||0.006|TWO_SIDED|90.0|0.32|0.72|||Linear mixed effects model||||% Inhibition: 52.2 (90% CI: 28.3, 68.2). The % Inhibition of FEV1\*hr (reduction of the allergen-induced LAR) for MK-1029 vs Placebo was calculated as 100\*(1-LSMR).|0.72|0.32|0.006
70892332|NCT01343407|141270673|OTHER||LS Mean Ratio (LSMR)|0.58||||0.012|TWO_SIDED|90.0|0.41|0.81|||Linear mixed effects model||||% Inhibition: 42.4 (90% CI: 19.3, 58.8) The % Inhibition of FEV1\*hr (reduction of the allergen-induced LAR) for MK-1029 vs Placebo was calculated as 100\*(1-LSMR).|0.81|0.41|0.012
70892333|NCT01343407|141270674|OTHER||LSM Difference|85.84|||<|0.001|TWO_SIDED|90.0|65.3|106.4|||Linear mixed effects model||Full inhibition is ≥74% inhibition of blood eosinophil CD11b expression at trough|||106.4|65.3|<0.001
70892334|NCT01343407|141270674|OTHER||LSM Difference|83.29|||<|0.001|TWO_SIDED|90.0|63.9|102.7|||Linear mixed effects model||Full inhibition is ≥74% inhibition of blood eosinophil CD11b expression at trough|||102.7|63.9|<0.001
70892335|NCT01046643|141270716|SUPERIORITY_OR_OTHER|||||||0.222||95.0||||Category = Medial Frontal Cortex|t-test, 2 sided|||"Category = Medial Frontal Cortex~p-value for null hypothesis = \<0.05"||||.222
70892336|NCT01046643|141270716|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||Category = Left Hippocampus|t-test, 2 sided|||"Category = Left Hippocampus~p-value for null hypothesis = \<0.05"||||.107
70892337|NCT01046643|141270716|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||Category = Medial Frontal Cortex|t-test, 2 sided|||"Category = Right Hippocampus~p-value for null hypothesis = \<0.05"||||.127
70892338|NCT01046643|141270716|SUPERIORITY_OR_OTHER|||||||0.954||95.0||||Category = Medial Frontal Cortex|t-test, 2 sided|||"Category = Medial Frontal Cortex~p-value for null hypothesis = \<0.05"||||.954
70892339|NCT01046643|141270716|SUPERIORITY_OR_OTHER|||||||0.385||95.0||||Category = Left Hippocampus|t-test, 2 sided|||"Category = Left Hippocampus~p-value for null hypothesis = \<0.05"||||.385
70892340|NCT01046643|141270716|SUPERIORITY_OR_OTHER|||||||0.31||95.0||||Category = Right Hippocampus|t-test, 2 sided|||"Category = Right Hippocampus~p-value for null hypothesis = \<0.05"||||.310
70892341|NCT01046643|141270717|SUPERIORITY_OR_OTHER|||||||0.594||95.0|||||t-test, 2 sided|||p-value for null hypothesis = \<0.05||||.594
70892342|NCT01046643|141270717|SUPERIORITY_OR_OTHER|||||||0.653||95.0|||||t-test, 2 sided|||p-value for null hypothesis = \<0.05||||.653
70892343|NCT01046643|141270718|SUPERIORITY_OR_OTHER|||||||0.452||95.0||||Category = Medial Frontal Cortex|t-test, 2 sided|||"Category = Medial Frontal Cortex~p-value for null hypothesis = \<0.05"||||.452
70892344|NCT01046643|141270718|SUPERIORITY_OR_OTHER|||||||0.868||95.0||||Category = Left Hippocampus|t-test, 2 sided|||"Category = Left Hippocampus~p-value for null hypothesis = \<0.05"||||.868
70892345|NCT01046643|141270718|SUPERIORITY_OR_OTHER|||||||0.549||95.0||||Category = Right Hippocampus|t-test, 2 sided|||"Category = Right Hippocampus~p-value for null hypothesis = \<0.05"||||.549
70892346|NCT01046643|141270718|SUPERIORITY_OR_OTHER|||||||0.124||95.0||||Category = Medial Frontal Cortex|t-test, 2 sided|||"Category = Medial Frontal Cortex~p-value for null hypothesis = \<0.05"||||.124
70892347|NCT01046643|141270718|SUPERIORITY_OR_OTHER|||||||0.158||95.0||||Category = Left Hippocampus|t-test, 2 sided|||"Category = Left Hippocampus~p-value for null hypothesis = \<0.05"||||.158
70892348|NCT01046643|141270718|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||Category = Right Hippocampus|t-test, 2 sided|||"Category = Right Hippocampus~p-value for null hypothesis = \<0.05"||||.055
70892349|NCT01046643|141270719|SUPERIORITY_OR_OTHER|||||||0.561||95.0|||||t-test, 2 sided|||p-value for null hypothesis = \<0.05||||.561
70892350|NCT01046643|141270719|SUPERIORITY_OR_OTHER|||||||0.726||95.0|||||t-test, 2 sided|||p-value for null hypothesis = \<0.05||||.726
70892351|NCT00289341|141270720|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||for injection site reaction only||||0.001
70892352|NCT00289341|141270720|SUPERIORITY_OR_OTHER||||||>|0.2||95.0|||||Fisher Exact|||for all other adverse events||||>0.2
70892353|NCT00289341|141270722|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||Linear Spline model|||||||0.016
70892354|NCT00553267|141270781|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.76|STANDARD_ERROR_OF_MEAN|0.52|<|0.0001||95.0|-3.77|-1.75||Doses tested against A10 in a hierarchical manner to address issues of multiplicity. T80/A10 was tested first, then T40/A10.|ANCOVA|Adjusted for baseline and country effect||"Testing that the combination treatments are superior to monotherapy A10.~The number of patients in the treatment arms ensure the tests have over 90% power."||-1.75|-3.77|<0.0001
70892355|NCT00553267|141270781|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.85|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001||95.0|-3.86|-1.84||Doses tested against A10 in a hierarchical manner to address issues of multiplicity. T80/A10 was tested first, then T40/A10.|ANCOVA|Adjusted for baseline and country effect||"Testing that the combination treatments are superior to monotherapy A10.~The number of patients in the treatment arms ensure the tests have over 90% power."||-1.84|-3.86|<0.0001
70892356|NCT00553267|141270782|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.66|STANDARD_ERROR_OF_MEAN|0.76|<|0.0001||95.0|-5.15|-2.16|||ANCOVA|Adjusted for baseline and country effect||||-2.16|-5.15|<0.0001
70892357|NCT00553267|141270782|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.85|STANDARD_ERROR_OF_MEAN|0.76|<|0.0001||95.0|-5.35|-2.36|||ANCOVA|Adjusted for baseline and country effect||||-2.36|-5.35|<0.0001
70892358|NCT00553267|141270783|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.002|TWO_SIDED|95.0|1.21|2.32|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.32|1.21|0.002
70892359|NCT00553267|141270783|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91|||<|0.001||95.0|1.37|2.65|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.65|1.37|<0.001
70892360|NCT00553267|141270784|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.35||||0.004||95.0|1.3|4.25|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||4.25|1.30|0.004
70892361|NCT00553267|141270784|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.33||||0.004||95.0|1.29|4.22|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||4.22|1.29|0.004
70892362|NCT00553267|141270785|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.002||95.0|1.21|2.34|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.34|1.21|0.002
70892363|NCT00553267|141270785|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92|||<|0.001||95.0|1.38|2.68|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.68|1.38|<0.001
70892364|NCT00553267|141270786|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.027||95.0|1.04|2.0|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.00|1.04|0.027
70892365|NCT00553267|141270786|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.008||95.0|1.12|2.15|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.15|1.12|0.008
70892366|NCT00553267|141270787|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.006||95.0|1.14|2.21|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.21|1.14|0.006
70892367|NCT00553267|141270787|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.002||95.0|1.2|2.32|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.32|1.20|0.002
70892368|NCT00553267|141270788|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Wilcoxon rank sum test|Stratified (for country) Wilcoxon rank sum test||||||0.006
70892369|NCT00553267|141270788|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon rank sum test|Stratified (for country) Wilcoxon rank sum test||||||<0.001
70963584|NCT02510560|141432068|SUPERIORITY|||||||0.115|||||||Stratified Van Elteren Test|||||||0.115
70963585|NCT02510560|141432068|SUPERIORITY|||||||0.243|||||||Stratified Van Elteren Test|||||||0.243
70892370|NCT00856583|141270849|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 90% confidence interval (CI) for the estimated all-cause mortality ratio was \<1.5 (pre-specified), the null hypothesis was rejected. With this limit, 7,600 patient years of exposure (PYE) were required to ensure 80% power at the 5% significance level of rejecting the null hypothesis when assuming a mortality of 2 deaths per 100 PYE. As the actual mortality was only about half that anticipated, more exposure was necessary and the duration of the study increased markedly.|Hazard Ratio (HR)|1.117||||0.05|TWO_SIDED|90.0|0.831|1.5|||Cox Proportional Hazard|Adjusted for: age, sex, time since last suicide attempt, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.|The hazard ratio is calculated as sertindole (numerator) versus risperidone (denominator).|The basis for the statistical analysis of the first primary outcome was the null hypothesis of an excess mortality in sertindole-treated patients compared to the mortality in risperidone-treated patients for the WRT+30 days period.||1.500|0.831|0.05
70892371|NCT00856583|141270849|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 90% CI for the estimated all-cause mortality ratio was \<1.5 (pre-specified), the null hypothesis was rejected. With this limit, 7,600 PYE were required to ensure 80% power at the 5% significance level of rejecting the null hypothesis when assuming a mortality of 2 deaths per 100 PYE. As the actual mortality was only about half that anticipated, more exposure was necessary and the duration of the study increased markedly.|Hazard Ratio (HR)|0.98|||<|0.05|TWO_SIDED|90.0|0.684|1.405|||Cox Proportional Hazard|Adjusted for: age, sex, time since last suicide attempt, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.|The hazard ratio is calculated as sertindole (numerator) versus risperidone (denominator).|The basis for the statistical analysis of the first primary outcome was the null hypothesis of an excess mortality in sertindole-treated patients compared to the mortality in risperidone-treated patients for the ORT period.||1.405|0.684|<0.05
70892372|NCT00856583|141270850|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.84||||0.0022|TWO_SIDED|95.0|1.45|5.55|||Cox Proportional Hazard|Adjusted: age, sex, time since last suicide attempt, last previous antipsychotic treatment (mono-/polytherapy), region, year since start of enrollment||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||5.55|1.45|0.0022
70892373|NCT00856583|141270851|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.73||||0.29|TWO_SIDED|95.0|0.63|4.78|||Cox Proportional Hazard|Adjusted for: age and sex.||The basis for the statistical analysis of time to 1st occurence of the secondary primary outcome (one patient in the risperidone group reported more than one occurrence of this event) was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||4.78|0.63|0.29
70892374|NCT00856583|141270852|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.34|TWO_SIDED|95.0|0.36|1.41|||Cox Proportional Hazard|Adjusted for: age, sex, time since last suicide attempt, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.41|0.36|0.34
70892375|NCT00856583|141270853|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.715||||0.26|TWO_SIDED|95.0|0.4|1.28|||Cox Proportional Hazard|Adjusted for: age, sex, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.28|0.40|0.26
70892376|NCT00856583|141270854|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.13||||0.081|TWO_SIDED|95.0|0.91|4.98|||Cox Proportional Hazard|Adjusted for: age, sex, last previous antipsychotic treatment (mono-/polytherapy).||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||4.98|0.91|0.081
70892377|NCT00856583|141270855|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.24|TWO_SIDED|95.0|0.33|1.32|||Cox Proportional Hazard|Adjusted for: age, sex, time since last suicide attempt, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.32|0.33|0.24
70892378|NCT00856583|141270856|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.59|TWO_SIDED|95.0|0.7|1.85|||Cox Proportional Hazard|Adjusted for: age, sex, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.85|0.70|0.59
70892379|NCT00856583|141270857|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.65|TWO_SIDED|95.0|0.66|1.29|||Cox Proportional Hazard|Adjusted for: age, sex, duration of schizophrenia, time since last suicide attempt, year since start of enrollment.||The basis for the statistical analysis of time to 1st occurence of this secondary outcome was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.29|0.66|0.65
70892380|NCT00856583|141270858|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.044|TWO_SIDED|95.0|0.45|0.99|||Cox Proportional Hazard|Adjusted for: age, sex, duration of schizophrenia, time since last suicide attempt, year since start of enrollment.||The basis for the statistical analysis of time to 1st occurence of this secondary outcome was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||0.99|0.45|0.044
70892381|NCT00856583|141270859|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26||||0.04|TWO_SIDED|95.0|1.01|1.57|||Cox Proportional Hazard|Adjusted for: age, sex, time since last suicide attempt, last antipsychotic medication (a-/typicals/both), region, year since start of enrollment.||The basis for the statistical analysis of time to 1st occurence of this secondary outcome was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.57|1.01|0.040
70963586|NCT02510560|141432069|SUPERIORITY|||||||0.714|||||||Stratified Van Elteren Test|||||||0.714
70963587|NCT02510560|141432069|SUPERIORITY|||||||0.243|||||||Stratified Van Elteren Test|||||||0.243
70892382|NCT00856583|141270860|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.35|||<|0.0001|TWO_SIDED|95.0|1.28|1.43|||Cox Proportional Hazard|Adjusted: disease duration, time since last suicide attempt, last antipsychotic medication (a-/typicals/both), region, year since start of enrollment.||The basis for the statistical analysis of this secondary outcome was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.43|1.28|<0.0001
70892383|NCT01944046|141270865|SUPERIORITY|||||||0.503||||||not adjusted primary outcome|Mixed Models Analysis|adjusted for baseline, age category, functionality category||||||0.503
70892384|NCT01944046|141270866|SUPERIORITY|||||||0.61||||||not adjusted primary outcome, p threshold 0.05|Mixed Models Analysis|adjustment for value at week 24,||||||0.61
70892385|NCT00823082|141270885|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
70892386|NCT00823082|141270886|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
70892387|NCT00823082|141270887|SUPERIORITY_OR_OTHER|||||||0.6115|TWO_SIDED||||||Fisher Exact|||At ICU discharge visit||||0.6115
70892388|NCT00823082|141270888|SUPERIORITY_OR_OTHER|||||||0.1211|TWO_SIDED||||||Fisher Exact|||Follow-up visit||||0.1211
70892389|NCT00823082|141270888|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||ICU discharge visit||||1.000
70892390|NCT00823082|141270889|SUPERIORITY_OR_OTHER|||||||0.487|TWO_SIDED||||||Fisher Exact|||ICU discharge visit||||0.4870
70892391|NCT00823082|141270890|SUPERIORITY_OR_OTHER|||||||0.3897|TWO_SIDED||||||Hodges-Lehmann test|||||||0.3897
70892392|NCT00823082|141270891|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0000
70892393|NCT00823082|141270892|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||Fisher Exact|||||||0.0004
70892394|NCT00823082|141270893|SUPERIORITY_OR_OTHER|||||||0.0209|TWO_SIDED||||||ANCOVA|||||||0.0209
70892395|NCT00823082|141270894|SUPERIORITY_OR_OTHER|||||||0.7433|TWO_SIDED||||||ANCOVA|||Number of units of packed red blood cells||||0.7433
70892396|NCT00823082|141270894|SUPERIORITY_OR_OTHER|||||||0.7453|TWO_SIDED||||||ANCOVA|||Units of fresh frozen plasma||||0.7453
70892397|NCT00823082|141270894|SUPERIORITY_OR_OTHER|||||||0.2705|TWO_SIDED||||||ANCOVA|||Units of platelets||||0.2705
70892398|NCT00823082|141270895|SUPERIORITY_OR_OTHER|||||||0.446|TWO_SIDED||||||Fisher Exact|||||||0.4460
70892399|NCT00823082|141270896|SUPERIORITY_OR_OTHER|||||||0.4936|TWO_SIDED||||||Fisher Exact|||||||0.4936
70892400|NCT00823082|141270897|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Follow-up visit||||1.000
70892401|NCT00823082|141270897|SUPERIORITY_OR_OTHER|||||||0.6218|TWO_SIDED||||||Fisher Exact|||ICU discharge visit||||0.6218
70892402|NCT00823082|141270898|SUPERIORITY_OR_OTHER|||||||0.9574|TWO_SIDED||||||Hodges-Lehmann|||||||0.9574
70892403|NCT00823082|141270899|SUPERIORITY_OR_OTHER|||||||0.7489|||||||Hodges-Lehmann test|||||||0.7489
70892404|NCT02328326|141270900|SUPERIORITY||Mean Difference (Net)|2.6||||0.048|TWO_SIDED|95.0|0.02|5.18|||Regression, Linear|Model was adjusted for baseline value of PAM, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in PAM is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' PAM score compared to patient participants in PACT.||5.18|0.02|0.048
70892405|NCT02328326|141270901|SUPERIORITY||Mean Difference (Net)|0.9||||0.32|TWO_SIDED|95.0|-0.87|2.67|||Regression, Linear|Model adjusted for baseline value of ukpds, insulin use, site, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline. Reference for comparison is PACT.|The null hypothesis was that change (baseline to 12 months) in ukpds 5 year risk score is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly decrease patient participants' 5-year cardiovascular event risk.||2.67|-0.87|0.32
70892406|NCT02328326|141270902|SUPERIORITY||Mean Difference (Net)|0.71||||0.01|TWO_SIDED|95.0|0.2|1.22|||Regression, Linear|Model adjusted for BL value of Healthy Eating, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Healthy Eating is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly change patient participants' Healthy Eating scores compared to patient participants in PACT.||1.22|0.20|0.01
70892407|NCT02328326|141270903|SUPERIORITY||Mean Difference (Net)|0.17||||0.33|TWO_SIDED|95.0|-0.17|0.51|||Regression, Linear|Model was adjusted for baseline value of A1c, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in A1c is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly decrease patient participants' A1c score compared to patient participants in PACT.||0.51|-0.17|0.33
70892408|NCT02328326|141270904|SUPERIORITY||Mean Difference (Net)|-2.82||||0.18|TWO_SIDED|95.0|-7.0|1.35|||Regression, Linear|Model was adjusted for baseline value of SBP, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40.|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in SBP is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly decrease patient participants' SBP score compared to patient participants in PACT.||1.35|-7.00|0.18
70892409|NCT02328326|141270905|SUPERIORITY||Mean Difference (Net)|0.12||||0.83|TWO_SIDED|95.0|-0.95|1.19|||Regression, Linear|Model was adjusted for baseline value of PAID, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in PAID is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' PAID score compared to patient participants in PACT.||1.19|-0.95|0.83
70963588|NCT04427501|141432094|SUPERIORITY||Odds Ratio (OR)|0.3|||||TWO_SIDED|95.0|0.15|0.58||||||||0.58|0.15|
70963589|NCT04427501|141432094|SUPERIORITY||Odds Ratio (OR)|0.12|||||TWO_SIDED|95.0|0.04|0.31||||||||0.31|0.04|
70963590|NCT04427501|141432095|SUPERIORITY||Odds Ratio (OR)|0.23|||||TWO_SIDED|95.0|0.13|0.4||||||||0.40|0.13|
70963591|NCT04427501|141432096|SUPERIORITY||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.221||0.6921|TWO_SIDED|95.0|-0.35|0.52|||Mixed Models Analysis|||||0.52|-0.35|0.6921
70892410|NCT02328326|141270906|SUPERIORITY||Mean Difference (Net)|0.11||||0.79|TWO_SIDED|95.0|-0.71|0.93|||Regression, Linear|Model was adjusted for baseline value of PEPPI, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in PEPPI is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' PEPPI score compared to patient participants in PACT.||0.93|-0.71|0.79
70892411|NCT02328326|141270907|SUPERIORITY||Median Difference (Net)|0.15||||0.21|TWO_SIDED|95.0|-0.09|0.4|||Regression, Linear|Model adjusted for BL value of Cho to HDL Ratio, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40.|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Chol to HDL Ratio is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly decrease patient participants' Chol to HDL Ratio score compared to patient participants in PACT.||0.40|-0.09|0.21
70892412|NCT02328326|141270909|SUPERIORITY||Mean Difference (Net)|0.3||||0.01|TWO_SIDED|95.0|0.08|0.53|||Regression, Linear|Model was adjusted for baseline value of IOCQ, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in IOCQ is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' IOCQ score compared to patient participants in PACT.||0.53|0.08|0.01
70892413|NCT02328326|141270910|EQUIVALENCE|Equivalent distribution among categories|difference in count|-1.0||||0.17|TWO_SIDED||||||Chi-squared||||Difference in count of those who stopped smoking in CO-IMPACT vs. those who stopped smoking in PACT.|||0.17
70892414|NCT02328326|141270911|SUPERIORITY||Mean Difference (Net)|-0.04||||0.87|TWO_SIDED|95.0|-0.56|0.47|||Regression, Linear|Model adjusted for BL value of Physical Activity, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Physical activity is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Physical activity score compared to patient participants in PACT.||0.47|-0.56|0.87
70892415|NCT02328326|141270912|SUPERIORITY||Mean Difference (Net)|0.23||||0.31|TWO_SIDED|95.0|-0.22|0.68|||Regression, Linear|Model adjusted for BL value of Blood Sugar Home Testing, insulin use, randomization strat. variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Blood Sugar Home Testing is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Blood Sugar Home Testing score compared to patient participants in PACT.||0.68|-0.22|0.31
70892416|NCT02328326|141270913|SUPERIORITY||Mean Difference (Net)|0.07||||0.87|TWO_SIDED|95.0|-0.76|0.89|||Regression, Linear|Model adjusted for BL value of Blood Pressure Home Testing, insulin use, randomization strat. variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Blood Pressure Home Testing is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Blood Pressure Home Testing score compared to patient participants in PACT.||0.89|-0.76|0.87
70892417|NCT02328326|141270914|SUPERIORITY||Mean Difference (Net)|-0.1||||0.56|TWO_SIDED|95.0|-0.42|0.23|||Regression, Linear|Model adjusted for BL value of Take Oral Meds as Prescribed, insulin use, randomization strat variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Take Oral Meds as Prescribed is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Take Oral Meds as Prescribed score compared to patient participants in PACT.||0.23|-0.42|0.56
70892418|NCT02328326|141270915|SUPERIORITY||Mean Difference (Net)|0.07||||0.67|TWO_SIDED|95.0|-0.26|0.41|||Regression, Linear|Model adjusted for baseline value of Take Insulin as Prescribed, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Take Insulin as prescribed is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Take Insulin as Prescribed compared to patient participants in PACT.||0.41|-0.26|0.67
70892419|NCT02328326|141270916|SUPERIORITY|The null hypothesis was that change (baseline to 12 months) in Foot Care is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Foot Care score compared to patient participants in PACT.|Median Difference (Net)|0.26||||0.29|TWO_SIDED|95.0|-0.22|0.75|||Regression, Linear|Model was adjusted for baseline value of Foot Care, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|||Net difference defined as 12 months minus baseline|0.75|-0.22|0.29
70892420|NCT02328326|141270917|SUPERIORITY||Mean Difference (Net)|0.4||||0.01|TWO_SIDED|95.0|0.09|0.71|||Regression, Linear|Model was adjusted for baseline value of SE, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in SE is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly change patient participants' SE scores compared to patient participants in PACT.||0.71|0.09|0.01
70892421|NCT02328326|141270918|SUPERIORITY||Mean Difference (Net)|0.1||||0.67|TWO_SIDED|95.0|-0.34|0.55|||Regression, Linear|Model was adjusted for baseline value of Lorig\_CP, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Lorig\_CP is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Lorig\_CP score compared to patient participants in PACT.||0.55|-0.34|0.67
70963592|NCT04427501|141432096|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.219||0.211|TWO_SIDED|95.0|-0.71|0.16|||Mixed Models Analysis|||||0.16|-0.71|0.2110
70892422|NCT02328326|141270919|SUPERIORITY||Mean Difference (Net)|0.28||||0.53|TWO_SIDED|95.0|-0.6|1.16|||Regression, Linear||Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in CSIS is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' CSIS score compared to patient participants in PACT.||1.16|-0.60|0.53
70892423|NCT02328326|141270920|SUPERIORITY||Mean Difference (Net)|0.32||||0.5|TWO_SIDED|95.0|-0.61|1.25|||Regression, Linear|Model was adjusted for baseline value of PAID\_CP, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baselineNet difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in PAID\_CP is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' PAID\_CP score compared to patient participants in PACT.||1.25|-0.61|0.50
70892424|NCT03452917|141270921|SUPERIORITY||Mean Difference (Final Values)|-2.9||||0.82|ONE_SIDED|95.0|-8.0||||Chi-squared||||||-8.0|0.82
70892425|NCT03452917|141270921|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.66|ONE_SIDED|95.0|-6.5||||Chi-squared||||||-6.5|0.66
70892426|NCT03452917|141270922|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.44|TWO_SIDED|95.0|-6.0|2.6|||Chi-squared|||||2.6|-6.0|0.44
70892427|NCT03452917|141270922|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.85|TWO_SIDED|95.0|-4.9|4.0|||Chi-squared|||||4.0|-4.9|0.85
70892428|NCT03452917|141270923|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.12|TWO_SIDED|95.0|-0.9|5.4|||Wilcoxon (Mann-Whitney)|||||5.4|-0.9|0.12
70892429|NCT03452917|141270923|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.41|TWO_SIDED|95.0|-2.5|3.6|||Wilcoxon (Mann-Whitney)|||||3.6|-2.5|0.41
70892430|NCT03452917|141270924|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.42|TWO_SIDED|95.0|-8.3|3.5|||Chi-squared|||||3.5|-8.3|0.42
70892431|NCT03452917|141270924|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.49|TWO_SIDED|95.0|-8.0|3.9|||Chi-squared|||||3.9|-8.0|0.49
70892432|NCT03452917|141270925|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.93|TWO_SIDED|95.0|-7.8|8.6|||Chi-squared|||||8.6|-7.8|0.93
70892433|NCT03452917|141270925|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.2|TWO_SIDED|95.0|-2.8|13.3|||Chi-squared|||||13.3|-2.8|0.20
70892434|NCT03452917|141270926|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.5|TWO_SIDED|95.0|-7.7|3.8|||Chi-squared|||||3.8|-7.7|0.50
70892435|NCT03452917|141270926|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.48|TWO_SIDED|95.0|-7.8|3.7|||Chi-squared|||||3.7|-7.8|0.48
70892436|NCT03452917|141270927|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.49|TWO_SIDED|95.0|-6.0|2.6|||Chi-squared|||||2.6|-6.0|0.49
70892437|NCT03452917|141270927|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.85|TWO_SIDED|95.0|-4.9|4.0|||Chi-squared|||||4.0|-4.9|0.85
70892438|NCT03198000|141270928|EQUIVALENCE|Prespecified equivalence interval of (-0.22, 0.44).|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.049||0.392|TWO_SIDED|95.0|-0.14|0.055|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.055|-0.140|0.392
70892439|NCT03198000|141270928|EQUIVALENCE|Prespecified equivalence interval of (-0.22, 0.44)|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.049||0.828|TWO_SIDED|95.0|-0.086|0.107|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.107|-0.086|0.828
70892440|NCT03198000|141270929|EQUIVALENCE|Prespecified equivalence interval of (0.80, 1.25).|Odds Ratio (OR)|0.87||||0.576|TWO_SIDED|95.0|0.539|1.411|||GEE model|GEE model with treatment as factor.||||1.411|0.539|0.576
70892441|NCT03198000|141270929|EQUIVALENCE|Prespecified equivalence interval of (0.80, 1.25)|Odds Ratio (OR)|0.87||||0.544|TWO_SIDED|95.0|0.552|1.368|||GEE model|GEE model with treatment as factor.||||1.368|0.552|0.544
70892442|NCT03198000|141270930|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.893|TWO_SIDED|95.0|-0.085|0.074|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.074|-0.085|0.893
70892443|NCT03198000|141270930|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.886|TWO_SIDED|95.0|-0.073|0.084|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.084|-0.073|0.886
70892444|NCT03198000|141270931|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.117|TWO_SIDED|95.0|-0.177|0.02|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.020|-0.177|0.117
70892445|NCT03198000|141270931|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.049||0.255|TWO_SIDED|95.0|-0.153|0.041|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.041|-0.153|0.255
70892446|NCT03198000|141270933|EQUIVALENCE|No equivalence interval was specified.|Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.21||0.085|TWO_SIDED|95.0|-0.05|0.78|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.78|-0.05|0.085
70892447|NCT03198000|141270933|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.21||0.269|TWO_SIDED|95.0|-0.18|0.64|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.64|-0.18|0.269
70892448|NCT03198000|141270934|EQUIVALENCE|No equivalence interval was specified.|Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.162|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.10|-0.60|0.162
70892449|NCT03198000|141270934|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.234|TWO_SIDED|95.0|-0.55|0.14|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.14|-0.55|0.234
70892450|NCT03198000|141270935|EQUIVALENCE|No equivalence interval was specified.|Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.398|TWO_SIDED|95.0|-0.48|0.19|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.19|-0.48|0.398
70892451|NCT03198000|141270935|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.233|TWO_SIDED|95.0|-0.54|0.13|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.13|-0.54|0.233
70892452|NCT00754845|141270998|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.01|TWO_SIDED|95.0|0.48|0.91|||Log Rank|Stratified by the stratification factors at randomization||||0.91|0.48|0.01
70892453|NCT00754845|141270999|SUPERIORITY|||||||0.007|||||||Log Rank|||||||0.007
70892454|NCT00754845|141271000|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.83|TWO_SIDED|95.0|0.73|1.28|||Log Rank|||||1.28|0.73|0.83
70892455|NCT00754845|141271001|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
70892456|NCT00358735|141271006|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
70892457|NCT00358735|141271007|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
70892458|NCT00358735|141271008|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Chi-squared|||||||0.0004
70892459|NCT00358735|141271010|SUPERIORITY_OR_OTHER|||||||0.953|||||||Chi-squared|||||||0.953
70892460|NCT00358735|141271011|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|||||||0.050
70892461|NCT00358735|141271012|SUPERIORITY_OR_OTHER|||||||0.01|||||||Chi-squared|||||||0.010
70892462|NCT00358735|141271013|SUPERIORITY_OR_OTHER|||||||0.507|||||||Chi-squared|||||||0.507
70892463|NCT00358735|141271014|SUPERIORITY_OR_OTHER|||||||0.052|||||||Chi-squared|||||||0.052
70892464|NCT00358735|141271015|SUPERIORITY_OR_OTHER|||||||0.798|||||||Chi-squared|||||||0.798
70892465|NCT00358735|141271016|SUPERIORITY_OR_OTHER|||||||0.036|||||||Chi-squared|||||||0.036
70892466|NCT03176693|141271019|EQUIVALENCE|A power analysis was calculated based on findings reported by Weingarten et al. of more frequent episodes of hypotension (defined as difference of mean systolic blood pressure \<30% from baseline) in phenoxybenzamine compared with doxazosin (15.7% versus 5.1%). Using a standard deviation of 16 and 11 (derived from reported interquartile ranges, assuming normal distribution), respectively, to achieve 80% power using an alpha =.05, a total sample size of 56 patients was determined.||||||0.56||||||Threshold for statistical significance = 0.05|Wilcoxon (Mann-Whitney)|||Null hypothesis: hemodynamic instability time will not differ between arms||||.56
70892467|NCT02279641|141271025|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|133.0|||||TWO_SIDED|90.0|111.0|159.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||159|111|
70892468|NCT02279641|141271025|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|67.9|||||TWO_SIDED|90.0|65.2|70.7|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||70.7|65.2|
70892469|NCT02279641|141271027|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|102.0|||||TWO_SIDED|90.0|93.3|111.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||111|93.3|
70892470|NCT02279641|141271027|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|61.8|||||TWO_SIDED|90.0|58.1|65.7|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||65.7|58.1|
70892471|NCT02279641|141271027|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|95.9|||||TWO_SIDED|90.0|88.4|104.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||104|88.4|
70892472|NCT02279641|141271028|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|103.0|||||TWO_SIDED|90.0|94.9|112.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||112|94.9|
70892473|NCT02279641|141271028|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|61.8|||||TWO_SIDED|90.0|58.1|65.7|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||65.7|58.1|
70892474|NCT02279641|141271030|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|89.5|||||TWO_SIDED|90.0|81.8|98.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||98.0|81.8|
70892475|NCT02279641|141271030|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|119.0|||||TWO_SIDED|90.0|114.0|125.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||125|114|
70892476|NCT02279641|141271031|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|87.5|||||TWO_SIDED|90.0|79.3|96.6|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||96.6|79.3|
70892477|NCT02279641|141271031|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|193.0|||||TWO_SIDED|90.0|177.0|210.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||210|177|
70892478|NCT02279641|141271031|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|105.0|||||TWO_SIDED|90.0|94.4|117.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||117|94.4|
70892479|NCT02279641|141271034|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|98.7|||||TWO_SIDED|95.0|87.7|111.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||111|87.7|
70892480|NCT02279641|141271035|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|95.9|||||TWO_SIDED|95.0|88.4|104.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||104|88.4|
70892481|NCT02279641|141271036|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|95.9|||||TWO_SIDED|95.0|88.4|104.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||104|88.4|
70892482|NCT02279641|141271037|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|101.0|||||TWO_SIDED|95.0|86.7|117.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||117|86.7|
70892483|NCT00746954|141271038|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||ANOVA|||Comparisons among groups||||0.45
70892484|NCT01763567|141271039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.8|STANDARD_DEVIATION|9.5|||TWO_SIDED|||||||||||||
70892485|NCT01763567|141271040|SUPERIORITY_OR_OTHER||percent of events correctly detected|16.7|||||TWO_SIDED|||||||||||||
70892486|NCT01763567|141271041|SUPERIORITY_OR_OTHER||percent of events correctly detected|88.9|||||TWO_SIDED|||||||||||||
70892487|NCT01763567|141271042|SUPERIORITY_OR_OTHER||% of false alert|85.8|||||TWO_SIDED|||||||||||||
70892488|NCT01763567|141271043|SUPERIORITY_OR_OTHER||% of false alert|56.5|||||TWO_SIDED|||||||||||||
70892489|NCT04401579|141271048|SUPERIORITY||Cox Proportional Hazard|1.15||||0.047|TWO_SIDED|95.0|1.0|1.31|||Log Rank|||||1.31|1.00|0.047
70892490|NCT04401579|141271064|SUPERIORITY||Risk Difference (RD)|-6.0|||||TWO_SIDED|95.0|-12.0|0.0||||||||0|-12|
70892491|NCT04401579|141271065|SUPERIORITY||Risk Difference (RD)|-5.0|||||TWO_SIDED|95.0|-10.0|0.0||||||||0|-10|
70892492|NCT04401579|141271075|SUPERIORITY||Odds Ratio (OR)|1.26||||0.44|TWO_SIDED|95.0|1.01|1.57|||Regression, Logistic|||||1.57|1.01|0.44
70892493|NCT04401579|141271085|SUPERIORITY||Cox Proportional Hazard|1.21||||0.002|TWO_SIDED|95.0|1.06|1.39|||Log Rank|||||1.39|1.06|0.002
70892494|NCT04401579|141271086|SUPERIORITY||Cox Proportional Hazard|1.2||||0.005|TWO_SIDED|95.0|1.05|1.38|||Log Rank|||||1.38|1.05|0.005
70892495|NCT04401579|141271087|SUPERIORITY||Cox Proportional Hazard|1.24||||0.003|TWO_SIDED|95.0|1.07|1.44|||Log Rank|||||1.44|1.07|0.003
70892496|NCT04401579|141271090|SUPERIORITY||Cox Proportional Hazard|1.11|||||TWO_SIDED|95.0|0.73|1.68||||||This analysis is for Asian participants.||1.68|0.73|
70892497|NCT04401579|141271090|SUPERIORITY||Cox Proportional Hazard|1.06|||||TWO_SIDED|95.0|0.75|1.5||||||This analysis is for Black or African American participants.||1.50|0.75|
70892498|NCT04401579|141271090|SUPERIORITY||Cox Proportional Hazard|1.13|||||TWO_SIDED|95.0|0.93|1.37||||||This analysis is for White participants.||1.37|0.93|
70892499|NCT04401579|141271090|SUPERIORITY||Cox Proportional Hazard|1.34|||||TWO_SIDED|95.0|1.03|1.74||||||This analysis is for Race of Other participants.||1.74|1.03|
70892500|NCT04401579|141271091|SUPERIORITY||Cox Proportional Hazard|1.31|||||TWO_SIDED|95.0|1.08|1.6||||||This analysis is for Not Hispanic or Latino participants||1.60|1.08|
70892501|NCT04401579|141271091|SUPERIORITY||Cox Proportional Hazard|1.08|||||TWO_SIDED|95.0|0.89|1.31||||||This analysis is for Hispanic or Latino participants.||1.31|0.89|
70892502|NCT04401579|141271092|SUPERIORITY||Cox Proportional Hazard|1.23|||||TWO_SIDED|95.0|1.04|1.46||||||This analysis is for Male participants.||1.46|1.04|
70892503|NCT04401579|141271092|SUPERIORITY||Cox Proportional Hazard|1.06|||||TWO_SIDED|95.0|0.85|1.32||||||This analysis is for Female participants.||1.32|0.85|
70892504|NCT00492349|141271119|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||ANCOVA|||Mixed model ANCOVA in which baseline served as the covariate and Smoking status and measurement occasions were between and within-groups factors, respectively.||||<0.05
70892505|NCT00492349|141271120|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||||||All treatment main and interaction effect p-values were \> 0.05.|ANCOVA|||Mixed model ANCOVA in which baseline CPT Detectability served as the covariate and Smoking status and measurement occasions were between and within-groups factors, respectively.||||>0.05
70892506|NCT00492349|141271121|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||ANCOVA|||Mixed model ANCOVA in which baseline Antisaccade Errors served as the covariate and Smoking status and measurement occasions were between and within-groups factors, respectively.||||<0.05
70892507|NCT01153633|141271148|SUPERIORITY_OR_OTHER|||||||0.2317||95.0||||F-test (2-sided), ANCOVA with baseline target ulcer size as covariate|F-test|||||||0.2317
70892508|NCT01153633|141271152|SUPERIORITY_OR_OTHER|||||||0.4905||95.0|||||Fisher Exact|||||||0.4905
70892509|NCT01153633|141271153|SUPERIORITY_OR_OTHER|||||||0.9945||95.0||||F-test (2-sided), ANCOVA with baseline target ulcer size as covariate|F-test|||||||0.9945
70892510|NCT00384085|141271154|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.56||||0.0628|TWO_SIDED|95.0|0.97|2.52||The type I error was controlled by performing a 2-tailed comparison at a p=0.0475 level for superiority testing.|Regression, Logistic|||||2.52|0.97|0.0628
70892511|NCT00384085|141271155|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of Lantus/Apidra-1 would be established if the upper limit of the 2 sided, 99.75% CI for the difference in the mean change from baseline between Lantus/Apidra-1 and Novolog Mix 70/30 was \<0.5%.|Adjusted Mean of difference|-0.34||||0.0359|TWO_SIDED|95.0|-0.82|0.15||The type I error was controlled by performing a 2-tailed comparison at a p=0.0025 level for noninferiority testing.|Mixed Models Analysis|||||0.15|-0.82|0.0359
70892512|NCT00384085|141271156|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.66||||0.0313|TWO_SIDED|95.0|1.04|2.64||The type I error was controlled by performing a 2-tailed comparison at a p=0.0475 level for superiority testing.|Regression, Logistic|||||2.64|1.04|0.0313
70892513|NCT00384085|141271157|SUPERIORITY_OR_OTHER||Adjusted Mean of difference|-0.31||||0.0565|TWO_SIDED|95.0|-0.63|0.01|||ANCOVA|||||0.01|-0.63|0.0565
70892514|NCT00384085|141271158|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.79||||0.014|TWO_SIDED|95.0|1.12|2.85|||Regression, Logistic|||||2.85|1.12|0.0140
70892515|NCT00384085|141271159|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.02||||0.9268|TWO_SIDED|95.0|0.61|1.71|||Regression, Logistic|||||1.71|0.61|0.9268
70892516|NCT00384085|141271159|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.11||||0.0107|TWO_SIDED|95.0|1.19|3.73|||Regression, Logistic|||||3.73|1.19|0.0107
70892517|NCT00384085|141271159|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.06||||0.0121|TWO_SIDED|95.0|1.17|3.61|||Regression, Logistic|||||3.61|1.17|0.0121
70892518|NCT00987467|141271176|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
70892519|NCT02646423|141271178|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.84|1.05||||||||1.05|0.84|
70892520|NCT02646423|141271179|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.86|1.16||||||||1.16|0.86|
70892521|NCT02646423|141271180|SUPERIORITY||Mean Difference (Net)|0.01|||||TWO_SIDED|95.0|-0.16|0.19||||||||0.19|-0.16|
70892522|NCT02646423|141271181|SUPERIORITY||Mean Difference (Net)|-0.38|||||TWO_SIDED|95.0|-1.81|1.05||||||||1.05|-1.81|
70892523|NCT02646423|141271182|SUPERIORITY||Mean Difference (Net)|-0.34|||||TWO_SIDED|95.0|-1.96|1.27||||||||1.27|-1.96|
70892524|NCT02646423|141271183|SUPERIORITY||Mean Difference (Net)|0.36|||||TWO_SIDED|95.0|-0.94|1.66||||||||1.66|-0.94|
70892525|NCT02646423|141271184|SUPERIORITY||Mean Difference (Net)|-0.03|||||TWO_SIDED|95.0|-0.09|0.03||||||||0.03|-0.09|
70892526|NCT02646423|141271185|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.46|1.51||||||||1.51|0.46|
70892527|NCT02646423|141271186|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.64|1.56||||||||1.56|0.64|
70892528|NCT02646423|141271187|SUPERIORITY||Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|0.64|2.81||||||||2.81|0.64|
70892529|NCT02646423|141271188|SUPERIORITY||Risk Ratio (RR)|2.0|||||TWO_SIDED|95.0|0.6|6.62||||||||6.62|0.60|
70892530|NCT02646423|141271189|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.72|1.35||||||||1.35|0.72|
70892531|NCT02646423|141271190|SUPERIORITY||Risk Ratio (RR)|1.13|||||TWO_SIDED|95.0|0.86|1.48||||||||1.48|0.86|
70892532|NCT01227889|141271197|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||<|0.0001|TWO_SIDED|95.0|0.26|0.6||The p value from a stratified log-rank test was adjusted for disease stage at screening.|Log Rank||HRs were estimated using a Pike estimator. HR from a stratified log-rank test was adjusted for disease stage at screening.|||0.60|0.26|<0.0001
70892533|NCT01227889|141271198|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35|||||TWO_SIDED|95.0|0.2|0.61|||||HRs were estimated using a Pike estimator. HR was adjusted for disease stage at screening.|||0.61|0.20|
70892534|NCT01227889|141271199|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.57|1.18|||||HRs were estimated using a Pike estimator. HR was adjusted for disease stage at screening.|||1.18|0.57|
70892535|NCT03073603|141271215|NON_INFERIORITY|We performed a non-inferiority test for the proportions of the drug continuation and drug discontinuation arms experiencing a new MS relapse and/or MRI Brain Lesion over the course of the study duration. The non-inferiority margin used was 8%.|Difference in proportion|0.0753||||0.521|TWO_SIDED|95.0|0.0063|0.15|||Exact binomial test|Exact binomial test for difference in two proportions||We tested the null hypothesis of inferiority with the proportion of disease events (i.e., new MS relapse and/or MRI brain lesion) for the drug discontinuation group being 8% greater than the proportion for the drug continuation group under the alternative that the two rates are equal.||0.1500|0.0063|0.521
70892536|NCT03073603|141271216|SUPERIORITY|||||||0.766|||||||Chi-squared|||||||0.766
70892537|NCT03073603|141271217|SUPERIORITY|||||||0.604|||||||t-test, 2 sided|||||||0.604
70892538|NCT03073603|141271218|SUPERIORITY|||||||0.198|||||||t-test, 2 sided|||||||0.198
70892539|NCT03073603|141271219|SUPERIORITY|||||||0.354|||||||t-test, 2 sided|||||||0.354
70892540|NCT03073603|141271220|SUPERIORITY|||||||0.831|||||||t-test, 2 sided|||||||0.831
70892541|NCT03073603|141271221|SUPERIORITY|||||||0.252|||||||t-test, 2 sided|||||||0.252
70892542|NCT03073603|141271222|SUPERIORITY|||||||0.983|||||||t-test, 2 sided|||||||0.983
70892543|NCT03073603|141271223|SUPERIORITY|||||||0.155|||||||t-test, 2 sided|||||||0.155
70892544|NCT03073603|141271224|SUPERIORITY|||||||0.748|||||||t-test, 2 sided|||||||0.748
70892545|NCT03073603|141271225|SUPERIORITY|||||||0.773|||||||t-test, 2 sided|||||||0.773
70892546|NCT03073603|141271226|SUPERIORITY|||||||0.224|||||||t-test, 2 sided|||||||0.224
70892547|NCT03073603|141271227|SUPERIORITY|||||||0.962|||||||t-test, 2 sided|||||||0.962
70892548|NCT03073603|141271228|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||||||0.005
70892549|NCT03073603|141271229|SUPERIORITY|||||||0.406|||||||t-test, 2 sided|||||||0.406
70892550|NCT03073603|141271230|SUPERIORITY|||||||0.348|||||||t-test, 2 sided|||||||0.348
70892551|NCT03073603|141271231|SUPERIORITY|||||||0.086|||||||t-test, 2 sided|||||||0.086
70892552|NCT03073603|141271232|SUPERIORITY|||||||0.575|||||||t-test, 2 sided|||||||0.575
70892553|NCT03073603|141271233|SUPERIORITY|||||||0.733|||||||Chi-squared|||||||0.733
70892554|NCT03073603|141271234|SUPERIORITY|||||||0.733|||||||Chi-squared|||||||0.733
70892555|NCT03073603|141271235|SUPERIORITY|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||||||0.036
70892556|NCT02079805|141271273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|||||TWO_SIDED|95.0|-0.89|1.78||||||Telmisartan 40 mg, Azilsartan 20 mg||1.78|-0.89|
70892557|NCT02347761|141271280|SUPERIORITY|A sample size of 215 subjects per treatment would give \~ 90% power to detect a treatment difference of 80 mL in the change from baseline in trough FEV1 at Week 12 between each of the 2 SUN-101 dose groups and placebo at alpha= 0.05, assuming a standard deviation of 255 mL and using a 2-sided test.|Least Squares Mea Difference (SE)|0.1036|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.0663|0.1409||The primary null hypothesis for this study is that the mean change from baseline in trough FEV1 at Week 12 for the SUN-101 50 mcg dose is equal to the mean change from baseline in trough FEV1 at Week 12 for Placebo.|MMixed Model Repeat Measurement|to control the family-wise Type I error rate,the Hochberg procedure(a tree-structured gatekeeping procedure)was used for comparisons of this endpoint|standard error of the least squares mean|The change from baseline in trough FEV1 was analyzed using a mixed model for repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit, visit by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1409|0.0663|<0.0001
70892558|NCT02347761|141271280|SUPERIORITY|A sample size of 215 subjects per treatment would give \~ 90% power to detect a treatment difference of 80 mL in the change from baseline in trough FEV1 at Week 12 between each of the 2 SUN-101 dose groups and placebo at alpha= 0.05, assuming a standard deviation of 255 mL and using a 2-sided test.|Least Squares Mean Difference (SE)|0.0961|STANDARD_ERROR_OF_MEAN|0.01896|<|0.0001|TWO_SIDED|95.0|0.0589|0.1334||The primary null hypothesis for this study is that the mean change from baseline in trough FEV1 at Week 12 for the SUN-101 50 mcg dose is equal to the mean change from baseline in trough FEV1 at Week 12 for Placebo.|Mixed Model Repeat Measurement|to control the family-wise Type I error rate,the Hochberg procedure(a tree-structured gatekeeping procedure)was used for comparisons of the endpoint.|Standard error of the least squares mean|The change from baseline in trough FEV1 was analyzed using a mixed model for repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit, visit by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1334|0.0589|<0.0001
70963593|NCT04427501|141432096|SUPERIORITY||Mean Difference (Net)|0.31|STANDARD_ERROR_OF_MEAN|0.225||0.163|TWO_SIDED|95.0|-0.13|0.76|||Mixed Models Analysis|||||0.76|-0.13|0.1630
70963594|NCT04427501|141432096|SUPERIORITY||Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|0.22||0.0099|TWO_SIDED|95.0|-1.0|-0.14|||Mixed Models Analysis|||||-0.14|-1.00|0.0099
70963595|NCT04427501|141432101|SUPERIORITY||Odds Ratio (OR)|1.45|||||TWO_SIDED|95.0|1.13|1.86||||||||1.86|1.13|
70892559|NCT02347761|141271281|SUPERIORITY||Least Squares Mean (SE)|0.1264|STANDARD_ERROR_OF_MEAN|0.02076|<|0.0001|TWO_SIDED|95.0|0.0856|0.1672||In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|Least squares mean (SE)|||The change from baseline in trough FEV1 was analyzed using mixed model repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1672|0.0856|<0.0001
70892560|NCT02347761|141271281|SUPERIORITY|In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|LS mean (SE)|0.1052|STANDARD_ERROR_OF_MEAN|0.0206|<|0.0001|TWO_SIDED|95.0|0.0647|0.1457|||LS mean (SE)|||The change from baseline in trough FEV1 was analyzed using mixed model repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1457|0.0647|<0.0001
70892561|NCT01040130|141271350|SUPERIORITY_OR_OTHER||Ratio to placebo|1.14|STANDARD_ERROR_OF_MEAN|0.04||0.0002||95.0|1.065|1.221|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline endurance time and period as fixed and patient as random effect. Means, CI back-transformed.|Olo 5 mcg divided by Placebo|||1.221|1.065|0.0002
70892562|NCT01040130|141271350|SUPERIORITY_OR_OTHER||Ratio to placebo|1.138|STANDARD_ERROR_OF_MEAN|0.04||0.0003||95.0|1.062|1.219|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline endurance time and period as fixed and patient as random effect. Means, CI back-transformed.|Olo 10 mcg divided by Placebo|||1.219|1.062|0.0003
70892563|NCT01040130|141271351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.112|0.252|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.252|0.112|<0.0001
70892564|NCT01040130|141271351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.104|0.245|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.245|0.104|<0.0001
70892565|NCT01040130|141271352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.766|STANDARD_ERROR_OF_MEAN|0.223||0.0007||95.0|-1.205|-0.326|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||-0.326|-1.205|0.0007
70892566|NCT01040130|141271352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.634|STANDARD_ERROR_OF_MEAN|0.225||0.0051||95.0|-1.077|-0.192|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||-0.192|-1.077|0.0051
70892567|NCT01040130|141271353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.258|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.191|0.325|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.325|0.191|<0.0001
70892568|NCT01040130|141271353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.294|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.226|0.362|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.362|0.226|<0.0001
70892569|NCT01040130|141271354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.107|0.252|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.252|0.107|<0.0001
70892570|NCT01040130|141271354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.037||0.0003||95.0|0.064|0.21|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.210|0.064|0.0003
70892571|NCT01040130|141271355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.103|STANDARD_ERROR_OF_MEAN|0.051||0.0447||95.0|-0.204|-0.002|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||-0.002|-0.204|0.0447
70892572|NCT01040130|141271355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.064|STANDARD_ERROR_OF_MEAN|0.052||0.2132||95.0|-0.166|0.037|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.037|-0.166|0.2132
70892573|NCT01040130|141271356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.088|STANDARD_ERROR_OF_MEAN|0.154||0.5698||95.0|-0.391|0.216|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.216|-0.391|0.5698
70892574|NCT01040130|141271356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.256|STANDARD_ERROR_OF_MEAN|0.155||0.1003||95.0|-0.05|0.561|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.561|-0.050|0.1003
70892575|NCT01040130|141271357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.122|STANDARD_ERROR_OF_MEAN|0.069||0.0784||95.0|-0.258|0.014|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.014|-0.258|0.0784
70892576|NCT01040130|141271357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.115|STANDARD_ERROR_OF_MEAN|0.07||0.1013||95.0|-0.252|0.023|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.023|-0.252|0.1013
70892577|NCT01040130|141271358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.066||0.0015||95.0|-0.339|-0.081|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||-0.081|-0.339|0.0015
70892578|NCT01040130|141271358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.373|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001||95.0|-0.503|-0.243|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||-0.243|-0.503|<0.0001
70892579|NCT01040130|141271359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.034||0.0005||95.0|0.052|0.185|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.185|0.052|0.0005
70892580|NCT01040130|141271359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.034||0.0073||95.0|0.025|0.159|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.159|0.025|0.0073
70892581|NCT01040130|141271360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.136|0.275|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.275|0.136|<0.0001
70892582|NCT01040130|141271360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.216|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.146|0.285|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.285|0.146|<0.0001
70892583|NCT01040130|141271361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.062||0.9239||95.0|-0.115|0.127|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.127|-0.115|0.9239
70892584|NCT01040130|141271361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.062||0.7368||95.0|-0.144|0.102|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.102|-0.144|0.7368
70892585|NCT01040130|141271362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.067||0.8302||95.0|-0.146|0.118|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.118|-0.146|0.8302
70892586|NCT01040130|141271362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.159|STANDARD_ERROR_OF_MEAN|0.068||0.0202||95.0|-0.292|-0.025|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||-0.025|-0.292|0.0202
70892587|NCT01040130|141271363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.056|0.123|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.123|0.056|<0.0001
70892588|NCT01040130|141271363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.068|0.134|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.134|0.068|<0.0001
70892589|NCT01040130|141271364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.224|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.191|0.258|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.258|0.191|<0.0001
70892590|NCT01040130|141271364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.193|0.259|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.259|0.193|<0.0001
70892591|NCT01040130|141271365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.031||0.0006||95.0|0.046|0.167|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.167|0.046|0.0006
70892592|NCT01040130|141271365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.031||0.0017||95.0|0.037|0.158|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.158|0.037|0.0017
70892593|NCT01040130|141271366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.285|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.227|0.342|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.342|0.227|<0.0001
70892594|NCT01040130|141271366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.233|0.348|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.348|0.233|<0.0001
70892595|NCT01040130|141271367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.318|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|0.207|0.429|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.429|0.207|<0.0001
70892596|NCT01040130|141271367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.303|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|0.192|0.414|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.414|0.192|<0.0001
70892597|NCT01040130|141271368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.585|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.47|0.701|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.701|0.470|<0.0001
70892598|NCT01040130|141271368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.618|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001||95.0|0.502|0.734|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.734|0.502|<0.0001
70892599|NCT02504294|141271397|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded since the lower bound of the 95% CI of the difference in percentage was greater than the non-inferiority margin (-12.5%).|Difference in Percentage|-1.3975|||||TWO_SIDED|95.0|-7.6503|4.8553||||||Clustered binomial analysis using logistic regression method was performed and generalized estimating equation method was used to construct 95 percent (%) two-sided confidence intervals (CIs).||4.8553|-7.6503|
70892600|NCT02504294|141271398|SUPERIORITY_OR_OTHER||LS Mean Difference|-1062.0|STANDARD_ERROR_OF_MEAN|803.95||0.1874|TWO_SIDED|95.0|-2643.2|519.2|||ANCOVA|||P-value was calculated using analysis of covariance (ANCOVA) model with treatment as factor and baseline ESA dose as covariate.||519.2|-2643.2|0.1874
70892601|NCT00968669|141271421|SUPERIORITY_OR_OTHER|||||||0.435|||||||ANOVA|Missing mean ACQ scores at Day 92 was imputed by last observation carried forward||||||0.435
70892602|NCT00968669|141271421|SUPERIORITY_OR_OTHER|||||||0.828|||||||ANOVA|Missing mean ACQ scores at Day 92 was imputed by last observation carried forward||||||0.828
70892603|NCT00968669|141271421|SUPERIORITY_OR_OTHER|||||||0.628|||||||ANOVA|Missing mean ACQ scores at Day 92 was imputed by last observation carried forward||||||0.628
70892604|NCT00968669|141271422|SUPERIORITY_OR_OTHER|||||||0.271|||||||Pairwise Poisson Regression|||||||0.271
70892605|NCT00968669|141271422|SUPERIORITY_OR_OTHER|||||||0.319|||||||Pairwise Poisson Regression|||||||0.319
70892606|NCT00968669|141271422|SUPERIORITY_OR_OTHER|||||||0.502|||||||Pairwise Poisson Regression|||||||0.502
70892607|NCT00968669|141271423|SUPERIORITY_OR_OTHER|||||||0.756|||||||Pairwise Poisson Regression|||||||0.756
70892608|NCT00968669|141271423|SUPERIORITY_OR_OTHER|||||||0.047|||||||Pairwise Poisson Regression|||||||0.047
70892609|NCT00968669|141271423|SUPERIORITY_OR_OTHER|||||||1|||||||Pairwise Poisson Regression|||||||1.000
70892610|NCT00968669|141271424|SUPERIORITY_OR_OTHER|||||||0.1764|||||||Fisher Exact|||||||0.1764
70892611|NCT00968669|141271424|SUPERIORITY_OR_OTHER|||||||0.4031|||||||Fisher Exact|||||||0.4031
70892612|NCT00968669|141271424|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
70892613|NCT00968669|141271425|SUPERIORITY_OR_OTHER|||||||0.8475|||||||Fisher Exact|||||||0.8475
70892614|NCT00968669|141271425|SUPERIORITY_OR_OTHER|||||||0.0811|||||||Fisher Exact|||||||0.0811
70892615|NCT00968669|141271425|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
70892616|NCT00968669|141271426|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.938||||0.144|||||||Log Rank|Stratified by atopic asthma and steroid use||||||0.144
70892617|NCT00968669|141271426|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.618||||0.395|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.395
70892618|NCT00968669|141271426|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.899||||0.863|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.863
70892619|NCT00968669|141271427|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.162||||0.717|||||||Log Rank|Stratified by atopic asthma and steroid use||||||0.717
70892620|NCT00968669|141271427|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.467||||0.07|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.070
70892621|NCT00968669|141271427|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.955||||0.934|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.934
70892622|NCT00968669|141271428|SUPERIORITY_OR_OTHER|||||||0.813|||||||ANOVA|||||||0.813
70892623|NCT00968669|141271428|SUPERIORITY_OR_OTHER|||||||0.29|||||||ANOVA|||||||0.290
70892624|NCT00968669|141271428|SUPERIORITY_OR_OTHER|||||||0.303|||||||ANOVA|||||||0.303
70892625|NCT00968669|141271429|SUPERIORITY_OR_OTHER|||||||0.764|||||||Fisher Exact|||Combined MEDI-528 treatment was compared to placebo||||0.764
70892626|NCT00968669|141271430|SUPERIORITY_OR_OTHER|||||||0.986|||||||Fisher Exact|||Combined MEDI-528 treatment was compared to placebo||||0.986
70892627|NCT00968669|141271431|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.955||||0.7171|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.7171
70892628|NCT00968669|141271431|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.942||||0.6219|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.6219
70892629|NCT00968669|141271431|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.909||||0.6182|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.6182
70892630|NCT00968669|141271432|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.952||||0.712|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.7120
70892631|NCT00968669|141271432|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.928||||0.5086|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.5086
70892632|NCT00968669|141271432|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.887||||0.5184|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.5184
70892633|NCT00968669|141271433|SUPERIORITY_OR_OTHER|||||||0.837|||||||Two-sample t-test|||||||0.837
70892634|NCT00968669|141271433|SUPERIORITY_OR_OTHER|||||||0.756|||||||Two-sample t-test|||||||0.756
70892635|NCT00968669|141271433|SUPERIORITY_OR_OTHER|||||||0.224|||||||Two-sample t-test|||||||0.224
70892636|NCT00968669|141271434|SUPERIORITY_OR_OTHER|||||||0.409|||||||Two-sample t-test|||||||0.409
70892637|NCT00968669|141271434|SUPERIORITY_OR_OTHER|||||||0.847|||||||Two-sample t-test|||||||0.847
70892638|NCT00968669|141271434|SUPERIORITY_OR_OTHER|||||||0.968|||||||Two-sample t-test|||||||0.968
70892639|NCT00968669|141271435|SUPERIORITY_OR_OTHER|||||||0.208|||||||Fisher Exact|||Combined MEDI-528 dose groups versus placebo||||0.208
70892640|NCT00968669|141271436|SUPERIORITY_OR_OTHER|||||||0.574|||||||Fisher Exact|||Combined MEDI-528 dose groups versus placebo||||0.574
70892641|NCT02255175|141271442|SUPERIORITY|||||||0.62|||||||t-test, 2 sided|t=.501, df=33||||||.620
70892642|NCT02255175|141271443|SUPERIORITY|||||||0.855|||||||t-test, 2 sided|t=.185, df=33||||||.855
70892643|NCT02255175|141271444|SUPERIORITY|||||||0.758|||||||t-test, 2 sided|t=-.310, df=33||||||.758
70892644|NCT02255175|141271445|SUPERIORITY|||||||0.518|||||||t-test, 2 sided|t=.653, df=33||||||.518
70892645|NCT02255175|141271446|SUPERIORITY|||||||0.645|||||||t-test, 2 sided|t=.465, df=33||||||.645
70892646|NCT02255175|141271447|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|t=2.56, df=33||||||.015
70892647|NCT02255175|141271448|SUPERIORITY|||||||0.486|||||||t-test, 2 sided|t=.705, df=33||||||.486
70892648|NCT02255175|141271449|SUPERIORITY|||||||0.831|||||||t-test, 2 sided|t=.216, df=33||||||.831
70892649|NCT02255175|141271450|SUPERIORITY|||||||0.0002|||||||Repeated measures ANOVA|F(1,33)=17.91||||||.0002
70892650|NCT00144339|141271451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|2.0||0.9524||95.0|-4.0|4.0|||t-test, 2 sided|Random-effects model|Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||4|-4|0.9524
70892651|NCT00144339|141271452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|2.0||0.2074||95.0|-2.0|6.0|||t-test, 2 sided|Random-effects model|Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||6|-2|0.2074
70892652|NCT00144339|141271453|SUPERIORITY_OR_OTHER|||||||0.2488||95.0|||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between||||||0.2488
70892653|NCT00144339|141271454|SUPERIORITY_OR_OTHER|||||||0.0145||95.0|||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between||||||0.0145
70892654|NCT00144339|141271455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|4.0||0.299||95.0|-12.0|4.0|||t-test, 2 sided||Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||4|-12|0.2990
70892655|NCT00144339|141271456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|4.0||0.8375||95.0|-9.0|7.0|||t-test, 2 sided||Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||7|-9|0.8375
70892656|NCT00144339|141271457|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-6.0|STANDARD_ERROR_OF_MEAN|4.0||0.1143||95.0|-14.0|2.0|||t-test, 2 sided||Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||2|-14|0.1143
70892657|NCT00144339|141271458|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|4.0||0.787||95.0|-9.0|7.0|||t-test, 2 sided||Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||7|-9|0.7870
70892658|NCT00144339|141271459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.13||0.784||95.0|-0.2|0.3|||t-test, 2 sided||Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||0.3|-0.2|0.7840
70892659|NCT00144339|141271460|SUPERIORITY_OR_OTHER|||||||0.2705||95.0|||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between||||||0.2705
70892660|NCT00144339|141271461|SUPERIORITY_OR_OTHER|||||||0.306||95.0|||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between||||||0.306
70892661|NCT00144339|141271462|SUPERIORITY_OR_OTHER|||||||0.8103||95.0|||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between||||||0.8103
70892662|NCT00144339|141271463|SUPERIORITY_OR_OTHER|||||||0.9814||95.0|||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between||||||0.9814
70892663|NCT00144339|141271464|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.81|0.91|||Log Rank|Cox regression with treatment|Median estimated by Kaplan-Meier estimates; hazard ratio shown as tio vs. placebo|Cox regression||0.91|0.81|<0.0001
70892664|NCT00144339|141271465|SUPERIORITY_OR_OTHER||Rate Ratio|0.86|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.81|0.91|||t-test, 2 sided||Ratio calculated as estimated number of events in tio/number of events in placebo|Poisson regression adjusted for overdispersion and treatment exposure||0.91|0.81|<0.0001
70892665|NCT00144339|141271466|SUPERIORITY_OR_OTHER|||||||0.3481||95.0|||||Fisher Exact|||||||0.3481
70892666|NCT00144339|141271467|SUPERIORITY_OR_OTHER||Rate Ratio|0.89|STANDARD_ERROR_OF_MEAN|0.03||0.0011||95.0|0.83|0.95|||t-test, 2 sided||Poisson regression adjusting for overdispersion with Pearson's method adjusting for treatment exposure. The logarithm of treatment exposure is used as offset when building the Poisson model.|Poisson regression adjusted for overdispersion and treatment exposure||0.95|0.83|0.0011
70892667|NCT00144339|141271468|SUPERIORITY_OR_OTHER|||||||0.1766||95.0|||||Fisher Exact|||||||0.1766
70892668|NCT00144339|141271469|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86|STANDARD_ERROR_OF_MEAN|0.04||0.0024||95.0|0.78|0.95|||Log Rank||Hazard ratio shown as tiotropium bromide vs. placebo|Cox regression||0.95|0.78|0.0024
70892669|NCT00144339|141271470|SUPERIORITY_OR_OTHER||Rate ratio|0.94|STANDARD_ERROR_OF_MEAN|0.06||0.3413||95.0|0.82|1.07|||t-test, 2 sided||Ratio of estimated number of events between tiotropium bromide and placebo|||1.07|0.82|0.3413
70892670|NCT00144339|141271471|SUPERIORITY_OR_OTHER||Rate ratio|1.01||||0.8624||95.0|0.87|1.18|||t-test, 2 sided||Ratio of estimated number of days of chronic obstructive pulmonary disease (COPD) exacerbation leading to hospitalization between tio and placebo|Poisson regression adjusting for overdispersion with Pearson's method adjusting for treatment exposure. The logarithm of treatment exposure is used as offset when building the Poisson model.||1.18|0.87|0.8624
70892671|NCT00144339|141271472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|||<|0.0001||95.0|0.077|0.098|||ANOVA|Repeated measures ANOVA||||0.098|0.077|<.0001
70892672|NCT00144339|141271473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|||<|0.0001||95.0|0.037|0.057|||ANOVA|Repeated measures ANOVA||||0.057|0.037|<.0001
70892673|NCT00144339|141271474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|||<|0.0001||95.0|0.087|0.11|||ANOVA|Repeated measures ANOVA||||0.110|0.087|<.0001
70892674|NCT00144339|141271475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|||<|0.0001||95.0|0.047|0.069|||ANOVA|Repeated measures ANOVA||||0.069|0.047|<.0001
70892675|NCT00144339|141271476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|||<|0.0001||95.0|0.091|0.115|||ANOVA|Repeated measures ANOVA||||0.115|0.091|<.0001
70892676|NCT00144339|141271477|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.054|||<|0.0001||95.0|0.042|0.065|||ANOVA|Repeated measures ANOVA||||0.065|0.042|<.0001
70892677|NCT00144339|141271478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|||<|0.0001||95.0|0.078|0.104|||ANOVA|Repeated measures ANOVA||||0.104|0.078|<.0001
70892678|NCT00144339|141271479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|||<|0.0001||95.0|0.04|0.066|||ANOVA|Repeated measures ANOVA||||0.066|0.040|<.0001
70892679|NCT00144339|141271480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|||<|0.0001||95.0|0.081|0.107|||ANOVA|Repeated measures ANOVA||||0.107|0.081|<.0001
70892680|NCT00144339|141271481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|||<|0.0001||95.0|0.049|0.075|||ANOVA|Repeated measures ANOVA||||0.075|0.049|<.0001
70892681|NCT00144339|141271482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.095|||<|0.0001||95.0|0.081|0.109|||ANOVA|Repeated measures ANOVA||||0.109|0.081|<.0001
70892682|NCT00144339|141271483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|||<|0.0001||95.0|0.047|0.075|||ANOVA|Repeated measures ANOVA||||0.075|0.047|<.0001
70892683|NCT00144339|141271484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|||<|0.0001||95.0|0.085|0.114|||ANOVA|Repeated measures ANOVA||||0.114|0.085|<.0001
70892684|NCT00144339|141271485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|||<|0.0001||95.0|0.051|0.08|||ANOVA|Repeated measures ANOVA||||0.080|0.051|<.0001
70892685|NCT00144339|141271486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.095|||<|0.0001||95.0|0.08|0.11|||ANOVA|Repeated measures ANOVA||||0.110|0.080|<.0001
70892686|NCT00144339|141271487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|||<|0.0001||95.0|0.045|0.076|||ANOVA|Repeated measures ANOVA||||0.076|0.045|<.0001
70892687|NCT00144339|141271488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|||<|0.0001||95.0|0.073|0.103|||ANOVA|Repeated measures ANOVA||||0.103|0.073|<.0001
70892688|NCT00144339|141271489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.049|||<|0.0001||95.0|0.033|0.065|||ANOVA|Repeated measures ANOVA||||0.065|0.033|<.0001
70892689|NCT00144339|141271490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|||<|0.0001||95.0|0.168|0.211|||ANOVA|Repeated measures ANOVA||||0.211|0.168|<.0001
70892690|NCT00144339|141271491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.055|||<|0.0001||95.0|0.037|0.073|||ANOVA|Repeated measures ANOVA||||0.073|0.037|<.0001
70892691|NCT00144339|141271492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.204|||<|0.0001||95.0|0.18|0.228|||ANOVA|Repeated measures ANOVA||||0.228|0.180|<.0001
70892692|NCT00144339|141271493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.055|||<|0.0001||95.0|0.034|0.076|||ANOVA|Repeated measures ANOVA||||0.076|0.034|<.0001
70892693|NCT00144339|141271494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|||<|0.0001||95.0|0.173|0.222|||ANOVA|Repeated measures ANOVA||||0.222|0.173|<.0001
70892694|NCT00144339|141271495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|||<|0.0001||95.0|0.026|0.07|||ANOVA|Repeated measures ANOVA||||0.070|0.026|<.0001
70892695|NCT00144339|141271496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.194|||<|0.0001||95.0|0.167|0.221|||ANOVA|Repeated measures ANOVA||||0.221|0.167|<.0001
70892696|NCT00144339|141271497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|||<|0.0001||95.0|0.026|0.074|||ANOVA|Repeated measures ANOVA||||0.074|0.026|<.0001
70892697|NCT00144339|141271498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.189|||<|0.0001||95.0|0.161|0.216|||ANOVA|Repeated measures ANOVA||||0.216|0.161|<.0001
70892698|NCT00144339|141271499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|||<|0.0001||95.0|0.035|0.084|||ANOVA|Repeated measures ANOVA||||0.084|0.035|<.0001
70892699|NCT00144339|141271500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|||<|0.0001||95.0|0.157|0.213|||ANOVA|Repeated measures ANOVA||||0.213|0.157|<.0001
70892700|NCT00144339|141271501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047||||0.0005||95.0|0.021|0.074|||ANOVA|Repeated measures ANOVA||||0.074|0.021|0.0005
70892701|NCT00144339|141271502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||<|0.0001||95.0|0.17|0.229|||ANOVA|Repeated measures ANOVA||||0.229|0.170|<.0001
70892702|NCT00144339|141271503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|||<|0.0001||95.0|0.038|0.093|||ANOVA|Repeated measures ANOVA||||0.093|0.038|<.0001
70892703|NCT00144339|141271504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|||<|0.0001||95.0|0.154|0.215|||ANOVA|Repeated measures ANOVA||||0.215|0.154|<.0001
70892704|NCT00144339|141271505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046||||0.002||95.0|0.017|0.076|||ANOVA|Repeated measures ANOVA||||0.076|0.017|0.0020
70892705|NCT00144339|141271506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||<|0.0001||95.0|0.139|0.201|||ANOVA|Repeated measures ANOVA||||0.201|0.139|<.0001
70892706|NCT00144339|141271507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.0365||95.0|0.002|0.061|||ANOVA|Repeated measures ANOVA||||0.061|0.002|0.0365
70892707|NCT00144339|141271508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||<|0.0001||95.0|0.147|0.192|||ANOVA|Repeated measures ANOVA||||0.192|0.147|<.0001
70892708|NCT00144339|141271509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038||||0.0002||95.0|0.018|0.058|||ANOVA|Repeated measures ANOVA||||0.058|0.018|0.0002
70892709|NCT00144339|141271510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|||<|0.0001||95.0|0.161|0.21|||ANOVA|Repeated measures ANOVA||||0.210|0.161|<.0001
70892710|NCT00144339|141271511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037||||0.0018||95.0|0.014|0.06|||ANOVA|Repeated measures ANOVA||||0.060|0.014|0.0018
70892711|NCT00144339|141271512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|||<|0.0001||95.0|0.151|0.201|||ANOVA|Repeated measures ANOVA||||0.201|0.151|<.0001
70892712|NCT00144339|141271513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.0069||95.0|0.009|0.055|||ANOVA|Repeated measures ANOVA||||0.055|0.009|0.0069
70892713|NCT00144339|141271514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|||<|0.0001||95.0|0.127|0.182|||ANOVA|Repeated measures ANOVA||||0.182|0.127|<.0001
70892714|NCT00144339|141271515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.002||95.0|0.015|0.065|||ANOVA|Repeated measures ANOVA||||0.065|0.015|0.0020
70892715|NCT00144339|141271516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|||<|0.0001||95.0|0.139|0.194|||ANOVA|Repeated measures ANOVA||||0.194|0.139|<.0001
70892716|NCT00144339|141271517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.0165||95.0|0.006|0.057|||ANOVA|Repeated measures ANOVA||||0.057|0.006|0.0165
70892717|NCT00144339|141271518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||<|0.0001||95.0|0.141|0.199|||ANOVA|Repeated measures ANOVA||||0.199|0.141|<.0001
70892718|NCT00144339|141271519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031||||0.0248||95.0|0.004|0.059|||ANOVA|Repeated measures ANOVA||||0.059|0.004|0.0248
70892719|NCT00144339|141271520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|||<|0.0001||95.0|0.136|0.196|||ANOVA|Repeated measures ANOVA||||0.196|0.136|<.0001
70892720|NCT00144339|141271521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.0004||95.0|0.022|0.078|||ANOVA|Repeated measures ANOVA||||0.078|0.022|0.0004
70892721|NCT00144339|141271522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|||<|0.0001||95.0|0.13|0.192|||ANOVA|Repeated measures ANOVA||||0.192|0.130|<.0001
70892722|NCT00144339|141271523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.027||||0.0809||95.0|-0.003|0.057|||ANOVA|Repeated measures ANOVA||||0.057|-0.003|0.0809
70892723|NCT00144339|141271524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|||<|0.0001||95.0|0.119|0.182|||ANOVA|Repeated measures ANOVA||||0.182|0.119|<.0001
70892724|NCT00144339|141271525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026||||0.0915||95.0|-0.004|0.057|||ANOVA|Repeated measures ANOVA||||0.057|-0.004|0.0915
70892725|NCT00144339|141271526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.88|||<|0.0001||95.0|-3.535|-2.226|||ANOVA|Repeated measures ANOVA||||-2.226|-3.535|<.0001
70892726|NCT00144339|141271527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.771|||<|0.0001||95.0|-3.461|-2.081|||ANOVA|Repeated measures ANOVA||||-2.081|-3.461|<.0001
70892727|NCT00144339|141271528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.593|||<|0.0001||95.0|-3.352|-1.834|||ANOVA|Repeated measures ANOVA||||-1.834|-3.352|<.0001
70892728|NCT00144339|141271529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.384|||<|0.0001||95.0|-3.191|-1.576|||ANOVA|Repeated measures ANOVA||||-1.576|-3.191|<.0001
70892729|NCT00144339|141271530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.423|||<|0.0001||95.0|-3.277|-1.569|||ANOVA|Repeated measures ANOVA||||-1.569|-3.277|<.0001
70963596|NCT04427501|141432101|SUPERIORITY||Odds Ratio (OR)|1.56|||||TWO_SIDED|95.0|1.24|1.95||||||||1.95|1.24|
70892730|NCT00144339|141271531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.345|||<|0.0001||95.0|-4.229|-2.462|||ANOVA|Repeated measures ANOVA||||-2.462|-4.229|<.0001
70892731|NCT00144339|141271532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.818|||<|0.0001||95.0|-3.742|-1.894|||ANOVA|Repeated measures ANOVA||||-1.894|-3.742|<.0001
70892732|NCT00144339|141271533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.303|||<|0.0001||95.0|-3.266|-1.34|||ANOVA|Repeated measures ANOVA||||-1.340|-3.266|<.0001
70892733|NCT00144339|141271534|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85|STANDARD_ERROR_OF_MEAN|0.06||0.0242||95.0|0.74|0.98|||Log Rank||Cox regression with treatment; hazard ratio shown as tiotropium bromide vs. placebo|||0.98|0.74|0.0242
70892734|NCT00144339|141271535|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87|STANDARD_ERROR_OF_MEAN|0.06||0.0339||95.0|0.76|0.99|||Log Rank||Cox regression; cut-off at 4 years ; vital status form intended at 4 years; hazard ratio shown as tio vs. placebo|Hazard ratio of all cause mortality vital status was information followed-up after discontinuation; vital status information up to 1440 days after the start of treatment was used||0.99|0.76|0.0339
70892735|NCT00144339|141271536|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89|STANDARD_ERROR_OF_MEAN|0.06||0.0859||95.0|0.79|1.02|||Log Rank||Cox regression; cut-off at 4 years plus 30 days; vital status form intended at 4 years; hazard ratio shown as tio vs. placebo|||1.02|0.79|0.0859
70892736|NCT00144339|141271537|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.1936||95.0|0.67|1.08|||Log Rank||Cox regression with treatment; hazard ratio shown as tiotropium bromide vs. placebo|||1.08|0.67|0.1936
70892737|NCT00144339|141271538|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.2377||95.0|0.71|1.09|||Log Rank||Cox regression; cut-off at 4 years plus 30 days; vital status form intended at 4 years; hazard ratio shown as tiotropium bromide vs. placebo|||1.09|0.71|0.2377
70892738|NCT00144339|141271539|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.84||||0.029||95.0|0.73|0.98|||Z-test|incidence rate = number of patients with event/ time at risk|Rate ratio of incidence rates (tiotropium/placebo)|||0.98|0.73|0.0290
70892739|NCT00144339|141271540|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|1.44||||0.1158||95.0|0.91|2.26|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||2.26|0.91|0.1158
70892740|NCT00144339|141271541|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.95||||0.7725||95.0|0.68|1.33|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||1.33|0.68|0.7725
70892741|NCT00144339|141271542|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|1.25||||0.2666||95.0|0.84|1.87|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||1.87|0.84|0.2666
70892742|NCT00144339|141271543|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.59||||0.0337||95.0|0.37|0.96|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||0.96|0.37|0.0337
70892743|NCT00144339|141271544|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.58||||0.0537||95.0|0.33|1.01|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||1.01|0.33|0.0537
70892744|NCT00144339|141271545|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.71||||0.0403||95.0|0.52|0.99|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||0.99|0.52|0.0403
70892745|NCT00144339|141271546|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.84||||0.0001||95.0|0.77|0.92|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||0.92|0.77|0.0001
70892746|NCT00144339|141271547|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|1.2||||0.4789||95.0|0.73|1.98|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||1.98|0.73|0.4789
70892747|NCT00144339|141271548|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.84||||0.0014||95.0|0.76|0.94|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||0.94|0.76|0.0014
70892748|NCT00144339|141271549|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.61||||0.0236||95.0|0.4|0.94|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||0.94|0.40|0.0236
70892749|NCT00144339|141271550|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.95||||0.5064||95.0|0.81|1.11|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||1.11|0.81|0.5064
70892750|NCT00144339|141271551|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.69||||0.0104||95.0|0.52|0.92|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||0.92|0.52|0.0104
70892751|NCT00690755|141271561|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|||||||.001
70892752|NCT01156701|141271577|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.15|||||TWO_SIDED|95.0|-1.42|1.12|||||Direct effect of Zanamivir prophylaxis on influenza risk|||1.12|-1.42|
70892753|NCT01156701|141271577|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.38|||||TWO_SIDED|95.0|-0.93|0.17|||||Total effect of zanamivir prophylaxis|||0.17|-0.93|
70892754|NCT01156701|141271577|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.14|||||TWO_SIDED|95.0|-0.75|0.47|||||Direct effect of zanamivir prophylaxis when index is treated|||0.47|-0.75|
70892755|NCT01156701|141271577|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.23|||||TWO_SIDED|95.0|-1.15|1.62|||||Risk in cohort 1 minus risk in cohort 2|||1.62|-1.15|
70892756|NCT01156701|141271577|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.24|||||TWO_SIDED|95.0|-0.51|0.03|||||Protective effect of zanamivir on susceptible risk|||0.03|-0.51|
70892757|NCT01156701|141271577|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||Direct effect of Zanamivir prophylaxis on influenza risk|||1.01|0.99|
70892758|NCT01156701|141271577|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Total effect of zanamivir prophylaxis|||1.00|0.99|
70892759|NCT01156701|141271577|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Direct effect of zanamivir prophylaxis when index is treated|||1.00|0.99|
70892760|NCT01156701|141271577|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.02|||||Risk in cohort 1 minus risk in cohort 2|||1.02|0.99|
70892761|NCT01156701|141271577|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Protective effect of zanamivir on susceptible risk|||1.00|0.99|
70892762|NCT01156701|141271578|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.4|||||TWO_SIDED|95.0|-1.17|0.36|||||Direct effect of Zanamivir prophylaxis on asthma risk|||0.36|-1.17|
70892763|NCT01156701|141271578|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.38|||||TWO_SIDED|95.0|-0.8|0.03|||||Total effect of zanamivir prophylaxis|||0.03|-0.80|
70892764|NCT01156701|141271578|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.28|||||TWO_SIDED|95.0|-0.75|0.18|||||Direct effect of zanamivir prophylaxis when index is treated|||0.18|-0.75|
70892765|NCT01156701|141271578|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.02|||||TWO_SIDED|95.0|-0.89|0.85|||||Risk in cohort 1 minus risk in cohort 2|||0.85|-0.89|
70892766|NCT01156701|141271578|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.31|0.11|||||Protective effect of zanamivir on susceptible risk|||0.11|-0.31|
70892767|NCT01156701|141271578|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Direct effect of Zanamivir prophylaxis on asthma risk|||1.00|0.99|
70892768|NCT01156701|141271578|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Total effect of zanamivir prophylaxis|||1.00|0.99|
70892769|NCT01156701|141271578|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Direct effect of zanamivir prophylaxis when index is treated|||1.00|0.99|
70892770|NCT01156701|141271578|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||Risk in cohort 1 minus risk in cohort 2|||1.01|0.99|
70892771|NCT01156701|141271578|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Protective effect of zanamivir on susceptible risk|||1.00|1.00|
70892772|NCT01156701|141271579|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.46|||||TWO_SIDED|95.0|-0.61|1.54|||||Direct effect of Zanamivir prophylaxis on pneumonia risk|||1.54|-0.61|
70892773|NCT01156701|141271579|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.25|||||TWO_SIDED|95.0|-0.45|-0.04|||||Total effect of zanamivir prophylaxis|||-0.04|-0.45|
70892774|NCT01156701|141271579|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.15|||||TWO_SIDED|95.0|-0.39|0.09|||||Direct effect of zanamivir prophylaxis when index is treated|||0.09|-0.39|
70892775|NCT01156701|141271579|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.72|||||TWO_SIDED|95.0|-0.38|1.81|||||Risk in cohort 1 minus risk in cohort 2|||1.81|-0.38|
70892776|NCT01156701|141271579|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.22|0.02|||||Protective effect of zanamivir on susceptible risk|||0.02|-0.22|
70892777|NCT01156701|141271579|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.02|||||Direct effect of Zanamivir prophylaxis on pneumonia risk|||1.02|0.99|
70892778|NCT01156701|141271579|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Total effect of zanamivir prophylaxis|||1.00|1.00|
70892779|NCT01156701|141271579|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Direct effect of zanamivir prophylaxis when index is treated|||1.00|1.00|
70892780|NCT01156701|141271579|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|1.0|1.02|||||Risk in cohort 1 minus risk in cohort 2|||1.02|1.00|
70892781|NCT01156701|141271579|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Protective effect of zanamivir on susceptible risk|||1.00|1.00|
70892782|NCT01156701|141271580|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.28|||||TWO_SIDED|95.0|-0.83|3.4|||||Direct effect of Zanamivir prophylaxis on bronchitis risk|||3.40|-0.83|
70892783|NCT01156701|141271580|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.24|||||TWO_SIDED|95.0|-0.98|0.47|||||Total effect of zanamivir prophylaxis|||0.47|-0.98|
70892784|NCT01156701|141271580|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.09|||||TWO_SIDED|95.0|-0.85|0.67|||||Direct effect of zanamivir prophylaxis when index is treated|||0.67|-0.85|
70892785|NCT01156701|141271580|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.53|||||TWO_SIDED|95.0|-0.7|3.76|||||Risk in cohort 1 minus risk in cohort 2|||3.76|-0.70|
70892786|NCT01156701|141271580|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.16|||||TWO_SIDED|95.0|-0.44|0.12|||||Protective effect of zanamivir on susceptible risk|||0.12|-0.44|
70892787|NCT01156701|141271580|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.99|1.03|||||Direct effect of Zanamivir prophylaxis on bronchitis risk|||1.03|0.99|
70892788|NCT01156701|141271580|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Total effect of zanamivir prophylaxis|||1.00|0.99|
70892789|NCT01156701|141271580|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||Direct effect of zanamivir prophylaxis when index is treated|||1.01|0.99|
70892790|NCT01156701|141271580|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|0.99|1.04|||||Risk in cohort 1 minus risk in cohort 2|||1.04|0.99|
70892791|NCT01156701|141271580|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Protective effect of zanamivir on susceptible risk|||1.00|1.00|
70892792|NCT01156701|141271581|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.14|||||TWO_SIDED|95.0|-3.08|2.79|||||Direct effect of Zanamivir prophylaxis on risk of any respiratory diagnosis|||2.79|-3.08|
70892793|NCT01156701|141271581|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.07|||||TWO_SIDED|95.0|-2.39|0.25|||||Total effect of zanamivir prophylaxis|||0.25|-2.39|
70892794|NCT01156701|141271581|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.08|||||TWO_SIDED|95.0|-2.51|0.35|||||Direct effect of zanamivir prophylaxis when index is treated|||0.35|-2.51|
70892795|NCT01156701|141271581|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.93|||||TWO_SIDED|95.0|-2.29|4.14|||||Risk in cohort 1 minus risk in cohort 2|||4.14|-2.29|
70892796|NCT01156701|141271581|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.01|||||TWO_SIDED|95.0|-0.58|0.59|||||Protective effect of zanamivir on susceptible risk|||0.59|-0.58|
70892797|NCT01156701|141271581|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.97|1.03|||||Direct effect of Zanamivir prophylaxis on risk of any respiratory diagnosis|||1.03|0.97|
70892798|NCT01156701|141271581|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.98|1.0|||||Total effect of zanamivir prophylaxis|||1.00|0.98|
70892799|NCT01156701|141271581|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.98|1.0|||||Direct effect of zanamivir prophylaxis when index is treated|||1.00|0.98|
70892800|NCT01156701|141271581|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.98|1.04|||||Risk in cohort 1 minus risk in cohort 2|||1.04|0.98|
70892801|NCT01156701|141271581|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Protective effect of zanamivir on susceptible risk|||1.00|0.99|
70892802|NCT03819660|141271612|OTHER||percentage|38.5|||||TWO_SIDED|||||||||||||
70892803|NCT00780962|141271619|SUPERIORITY||Percentage Difference|0.6|||>|0.5|TWO_SIDED|95.0|-4.8|6.0|||Wald|||"The study was powered to find a 10% absolute risk reduction in the rate of contrast-induced nephropathy (a=.05, 90% power). We initially estimated the need for 600 patients and repowered to 800 patients after the 1st interim analysis. The study was halted for futility at the 2nd interim analysis.~Reported here 357 (89.4%) of the 399 enrolled subjects who completed a second blood draw at the time the study closed."||6.0|-4.8|>0.5
70892804|NCT01422070|141271635|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63|||<|0.05|TWO_SIDED|95.0|0.45|0.88|||generalized estimating equation|Generalized estimating equation adjusts the confidence interval for the correlation of outcomes within-centre.|The fully adjusted multivariable logistic regression analysis showed an OR of 0.63 in favour of the presence of an intermediate care unit in the hospital|The null hypothesis was that hospital mortality of patients admitted to intensive care units with intermediate care unit in the hospital is similar to that of the patients admitted to intensive care units without intermediate care unit in the hospital||0.88|0.45|<0.05
70892805|NCT03351049|141271636|SUPERIORITY|||||||0.8|||||||Chi-squared|||Compare the effectiveness of reactive support surfaces with and without low air loss in preventing pressure injuries||||0.8
70892806|NCT02877485|141271637|OTHER||Mean Difference (Net)|1.5||||0.7|TWO_SIDED|95.0|-6.0|8.9||"Statistical Tests:~Independent t-test to assess differences in mean change in NOSE scores when comparing the two study groups, and p\<0.05 deemed statistically significant"|t-test, 2 sided||Change in Mean NOSE score from baseline to post saline versus change in NOSE score from baseline to post intranasal steroid.|"1\) H0: mean change in NOSE score from baseline after in study group 1 = mean change in NOSE score from baseline in study group 2~Power calculation: To detect a 20% difference in NOSE scores with 80% power and a 2-sided alpha level of 0.05 required 20 participants per study group, for a total of 40 participants."||8.9|-6.0|0.7
70892807|NCT02877485|141271638|OTHER||Mean Difference (Final Values)|-50.0|STANDARD_DEVIATION|27.6|<|0.001|TWO_SIDED|||||Paired t-tests to assess differences in mean NOSE score when the treatment groups were combined (saline arm+ steroid arm) at five post-operative time intervals compared to the combined preoperative baseline scores. Significance at p\<0.05.|Paired t-test|||H0: Mean pre- treatment baseline patient NOSE score = Mean post- treatment baseline patient NOSE score.||||<0.001
70892808|NCT03762135|141271681|SUPERIORITY|||||||0.044||||||This relates to the entirety of the 6-week period.|GEE Linear Regression|Generalized Estimation Equation Linear Regression||||||0.044
70892809|NCT01812044|141271701|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|P-value based on Wilcoxon rank sum test of difference in medians between groups.||||||0.035
70892810|NCT01812044|141271701|SUPERIORITY_OR_OTHER|||||||0.189|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|P-value based on Wilcoxon rank sum test of difference in medians between groups.||||||0.189
70892811|NCT01812044|141271701|SUPERIORITY_OR_OTHER|||||||0.298|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|P-value based on Wilcoxon rank sum test of difference in medians between groups.||||||0.298
70892812|NCT00071487|141271753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||0.3677|TWO_SIDED|95.0|-19.4|7.2||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using a last observation carried forward (LOCF) imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||7.2|-19.4|0.3677
70892813|NCT00071487|141271753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9||||0.4244|TWO_SIDED|95.0|-8.7|20.6||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||20.6|-8.7|0.4244
70892814|NCT00071487|141271753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5||||0.3296|TWO_SIDED|95.0|-19.6|6.6||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||6.6|-19.6|0.3296
70892815|NCT00071487|141271754|SUPERIORITY_OR_OTHER|||||||0.6423||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required protocol-prohibited medications were considered to have a flare on the date the prohibited medication was started or date of the first flare, whichever came first. Patients who withdrew from the study for reasons other than SLE disease manifestations or hospitalization related to SLE or who missed 2 or more consecutive visits were censored at the time of the last assessment.||||0.6423
70892816|NCT00071487|141271754|SUPERIORITY_OR_OTHER|||||||0.8536||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required protocol-prohibited medications were considered to have a flare on the date the prohibited medication was started or date of the first flare, whichever came first. Patients who withdrew from the study for reasons other than SLE disease manifestations or hospitalization related to SLE or who missed 2 or more consecutive visits were censored at the time of the last assessment.||||0.8536
70892817|NCT00071487|141271754|SUPERIORITY_OR_OTHER|||||||0.9705||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required protocol-prohibited medications were considered to have a flare on the date the prohibited medication was started or date of the first flare, whichever came first. Patients who withdrew from the study for reasons other than SLE disease manifestations or hospitalization related to SLE or who missed 2 or more consecutive visits were censored at the time of the last assessment.||||0.9705
70892818|NCT00071487|141271755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.1||||0.1763|TWO_SIDED|95.0|-22.4|4.1||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||4.1|-22.4|0.1763
70892819|NCT00071487|141271755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3||||0.7112|TWO_SIDED|95.0|-20.9|14.3||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||14.3|-20.9|0.7112
70892820|NCT00071487|141271755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.4||||0.332|TWO_SIDED|95.0|-22.2|7.5||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||7.5|-22.2|0.3320
70892821|NCT00071487|141271756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.6||||0.1287|TWO_SIDED|95.0|-65.6|8.4||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||8.4|-65.6|0.1287
70892822|NCT00071487|141271756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.98||||0.8807|TWO_SIDED|95.0|-36.2|42.1||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||42.1|-36.2|0.8807
70892823|NCT00071487|141271756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.41||||0.1131|TWO_SIDED|95.0|-68.1|7.3||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||7.3|-68.1|0.1131
70892824|NCT00071487|141271757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.7823|TWO_SIDED|95.0|-13.8|10.4||P-value was not adjusted for multiple testing|t-test, 2 sided|||Missing data for BILAG were handled as described previously for SELENA SLEDAI.||10.4|-13.8|0.7823
70892825|NCT00071487|141271757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.4||||0.1774|TWO_SIDED|95.0|-18.2|3.4||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data for BILAG were handled as described previously for SELENA SLEDAI.||3.4|-18.2|0.1774
70892826|NCT00071487|141271757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.6406|TWO_SIDED|95.0|-14.8|9.1|||t-test, 2 sided|P-value was not adjusted for multiple testing.||Missing data for BILAG were handled as described previously for SELENA SLEDAI.||9.1|-14.8|0.6406
70892827|NCT00071487|141271758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8||||0.7822|TWO_SIDED|95.0|-38.6|29.1||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data for BILAG were handled as described previously for SELENA SLEDAI.||29.1|-38.6|0.7822
70892828|NCT00071487|141271758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9||||0.3332|TWO_SIDED|95.0|-45.3|15.4||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data for BILAG were handled as described previously for SELENA SLEDAI.||15.4|-45.3|0.3332
70892829|NCT00071487|141271758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.7||||0.466|TWO_SIDED|95.0|-46.9|21.5||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data for BILAG were handled as described previously for SELENA SLEDAI.||21.5|-46.9|0.4660
70892830|NCT00071487|141271759|SUPERIORITY_OR_OTHER|||||||0.5615||95.0||||P-value was not adjusted for multiple comparisons.|Log Rank|||Missing data for BILAG were handled as described previously for SELENA SLEDAI (SLE Flare Index).||||0.5615
70892831|NCT00071487|141271759|SUPERIORITY_OR_OTHER|||||||0.7593||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Missing data for BILAG were handled as described previously for SELENA SLEDAI (SLE Flare Index).||||0.7593
70892832|NCT00071487|141271759|SUPERIORITY_OR_OTHER|||||||0.2273||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Missing data for BILAG were handled as described previously for SELENA SLEDAI (SLE Flare Index).||||0.2273
70892833|NCT00071487|141271760|SUPERIORITY_OR_OTHER||percent difference from placebo|-7.1||||0.4355|TWO_SIDED|95.0|-24.7|10.6||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who dropped out or had missing data were considered failures.||10.6|-24.7|0.4355
70892834|NCT00071487|141271760|SUPERIORITY_OR_OTHER||percent difference from placebo|4.4||||0.6669|TWO_SIDED|95.0|-15.5|24.2||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who dropped out or had missing data were considered failures.||24.2|-15.5|0.6669
70892835|NCT00071487|141271760|SUPERIORITY_OR_OTHER||percent difference from placebo|17.7||||0.0882|TWO_SIDED|95.0|-2.5|37.9||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who dropped out or had missing data were considered failures.||37.9|-2.5|0.0882
70892836|NCT01262651|141271775|SUPERIORITY||Median Difference (Final Values)|3.41||||0.0854|TWO_SIDED|95.0|0.0|8.16|||Wilcoxon (Mann-Whitney)|||||8.16|0.00|0.0854
70892837|NCT04837482|141271795|NON_INFERIORITY|Noninferiority of AGN-190584 was concluded if the lower bound of the 95% CI of the least-square mean difference between AGN-190584 and vehicle was greater than the pre-specified margin of -0.25.|Least-Square (LS) Mean|-0.224|STANDARD_ERROR_OF_MEAN|0.0602||0.0006|TWO_SIDED|95.0|-0.346|-0.103|||Mixed Models Analysis|Linear mixed-effects model with repeated measures||||-0.103|-0.346|0.0006
70892838|NCT02896855|141271870|OTHER||Stratified Hazard Ratio|0.69||||0.0418|TWO_SIDED|95.0|0.49|0.99|||Log Rank|A two-sided log-rank test was used, stratified by disease type and hormone-receptor status.|This stratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model, stratified by disease type and hormone-receptor status, was used to estimate HR and its 95% CI.|This was for the primary analysis. Hypothesis testing is considered exploratory in this bridging study.||0.99|0.49|0.0418
70892839|NCT02896855|141271870|OTHER||Unstratified Hazard Ratio|0.71||||0.0556|TWO_SIDED|95.0|0.5|1.01|||Log Rank|This two-sided log-rank test was unstratified.|This unstratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model was used to estimate HR and its 95% CI.|This was for the primary analysis. Hypothesis testing is considered exploratory in this bridging study.||1.01|0.50|0.0556
70892840|NCT02896855|141271870|OTHER||Stratified Hazard Ratio|0.6||||0.0008|TWO_SIDED|95.0|0.45|0.81|||Log Rank|A two-sided log-rank test was used, stratified by disease type and hormone-receptor status.|This stratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model, stratified by disease type and hormone-receptor status, was used to estimate HR and its 95% CI.|This was for the final analysis. Hypothesis testing is considered exploratory in this bridging study.||0.81|0.45|0.0008
70892841|NCT02896855|141271870|OTHER||Unstratified Hazard Ratio|0.63||||0.0019|TWO_SIDED|95.0|0.47|0.85|||Log Rank|This two-sided log-rank test was unstratified.|This unstratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model was used to estimate HR and its 95% CI.|This was for the final analysis. Hypothesis testing is considered exploratory in this bridging study.||0.85|0.47|0.0019
70892842|NCT02896855|141271872|OTHER||Stratified Hazard Ratio|0.68||||0.0658|TWO_SIDED|95.0|0.45|1.03|||Log Rank|A two-sided log-rank test was used, stratified by disease type and hormone-receptor status.|This stratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model, stratified by disease type and hormone-receptor status, was used to estimate HR and its 95% CI.|Hypothesis testing is considered exploratory in this bridging study.||1.03|0.45|0.0658
70892843|NCT02896855|141271872|OTHER||Unstratified Hazard Ratio|0.7||||0.0864|TWO_SIDED|95.0|0.46|1.06|||Log Rank|This two-sided log-rank test was unstratified.|This unstratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model was used to estimate HR and its 95% CI.|Hypothesis testing is considered exploratory in this bridging study.||1.06|0.46|0.0864
70892844|NCT02896855|141271874|OTHER||Difference in Objective Response|9.98||||0.1126|TWO_SIDED|95.0|-2.65|22.6|||Cochran-Mantel-Haenszel|Statistical test is stratified by disease type and hormone receptor status.|The difference in objective response is calculated as Arm B: Pertuzumab minus Arm A: Placebo. 95% CI was calculated using Hauck-Anderson method.|Hypothesis testing is considered exploratory in this bridging study.||22.60|-2.65|0.1126
70892845|NCT02896855|141271874|OTHER||Difference in Objective Response|9.98||||0.1108|TWO_SIDED|95.0|-2.65|22.6|||Fisher Exact|Unadjusted|The difference in objective response is calculated as Arm B: Pertuzumab minus Arm A: Placebo. 95% CI was calculated using Hauck-Anderson method.|Hypothesis testing is considered exploratory in this bridging study.||22.60|-2.65|0.1108
70963597|NCT04427501|141432101|SUPERIORITY||Odds Ratio (OR)|1.64|||||TWO_SIDED|95.0|1.06|2.53||||||||2.53|1.06|
70892846|NCT02896855|141271875|OTHER||Cox Proportional Hazard|0.78||||0.2867|TWO_SIDED|95.0|0.49|1.24|||Log Rank|Two-sided log-rank test was used, stratified by disease type and hormone-receptor status.|This stratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model, stratified by disease type and hormone-receptor status, was used to estimate HR and its 95% CI.|Hypothesis testing is considered exploratory in this bridging study.||1.24|0.49|0.2867
70892847|NCT02896855|141271882|OTHER||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-1.96|0.75|||||The treatment difference for change from baseline to maximum on-treatment decrease in LVEF is defined as Arm B: Pertuzumab minus Arm A: Placebo.|||0.75|-1.96|
70892848|NCT00407537|141271914|SUPERIORITY_OR_OTHER_LEGACY||LSMean difference|-4.72|||<|0.001|TWO_SIDED|95.0|-5.55|-3.89||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|It was estimated that each study site would on average complete 8 evaluable participants, therefore enrolling 164 sites, 1968 participants would provide at least 90% power to detect a 10% relative reduction in the 10-year predicted risk of total CHD at 12 months (as calculated from the Framingham model) from the control arm based on a two-sided t-test with a 5% significance level.||-3.89|-5.55|<0.001
70892849|NCT00407537|141271915|SUPERIORITY_OR_OTHER_LEGACY||LSMean difference|-4.76|||<|0.001|TWO_SIDED|95.0|-5.58|-3.93||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|||-3.93|-5.58|<0.001
70892850|NCT00407537|141271916|SUPERIORITY_OR_OTHER_LEGACY||LSMean difference|-0.97|||<|0.001|TWO_SIDED|95.0|-1.23|-0.72||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|||-0.72|-1.23|<0.001
70892851|NCT00407537|141271917|SUPERIORITY_OR_OTHER_LEGACY||LSMean difference|-0.88|||<|0.001|TWO_SIDED|95.0|-1.16|-0.59||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|||-0.59|-1.16|<0.001
70892852|NCT00407537|141271918|SUPERIORITY_OR_OTHER_LEGACY||LSMean difference|-1.35|||<|0.001|TWO_SIDED|95.0|-1.56|-1.15||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|||-1.15|-1.56|<0.001
70892853|NCT00407537|141271919|SUPERIORITY_OR_OTHER_LEGACY||LSMean difference|-1.35|||<|0.001|TWO_SIDED|95.0|-1.57|-1.14||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|||-1.14|-1.57|<0.001
70892854|NCT00407537|141271924|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.15|||<|0.007|TWO_SIDED|95.0|-5.42|-0.88|||Mixed-effect linear model|||||-0.88|-5.42|<0.007
70892855|NCT00407537|141271925|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.61|||<|0.011|TWO_SIDED|95.0|-2.86|-0.37|||Mixed-effect linear model|||||-0.37|-2.86|<0.011
70892856|NCT00407537|141271926|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.75|||<|0.001|TWO_SIDED|95.0|-8.0|-3.5|||Mixed-effect linear model|||||-3.50|-8.00|<0.001
70892857|NCT00407537|141271927|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.17|||<|0.001|TWO_SIDED|95.0|-4.42|-1.92|||Mixed-effect linear model|||||-1.92|-4.42|<0.001
70892858|NCT00407537|141271928|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.94|||<|0.001|TWO_SIDED|95.0|-43.71|-34.17||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||TC||-34.17|-43.71|<0.001
70892859|NCT00407537|141271928|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-35.31|||<|0.001|TWO_SIDED|95.0|-39.64|-30.99||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||LDL||-30.99|-39.64|<0.001
70892860|NCT00407537|141271928|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.99||||0.087|TWO_SIDED|95.0|-0.14|2.13||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||HDL||2.13|-0.14|0.087
70892861|NCT00407537|141271928|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-23.65|||<|0.001|TWO_SIDED|95.0|-32.6|-14.7||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effects linear model|||Triglycerides||-14.70|-32.60|<0.001
70963598|NCT04427501|141432102|SUPERIORITY||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|1.17|1.93||||||||1.93|1.17|
70963599|NCT04427501|141432102|SUPERIORITY||Odds Ratio (OR)|1.67|||||TWO_SIDED|95.0|1.33|2.09||||||||2.09|1.33|
70892862|NCT00407537|141271929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-33.07|||<|0.001|TWO_SIDED|95.0|-37.57|-28.56||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||TC||-28.56|-37.57|<0.001
70892863|NCT00407537|141271929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-29.83|||<|0.001|TWO_SIDED|95.0|-33.7|-25.95||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||LDL||-25.95|-33.70|<0.001
70892864|NCT00407537|141271929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.58||||0.379|TWO_SIDED|95.0|-0.71|1.86||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||HDL||1.86|-0.71|0.379
70892865|NCT00407537|141271929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.27|||<|0.001|TWO_SIDED|95.0|-28.72|-7.81||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||Triglycerides||-7.81|-28.72|<0.001
70892866|NCT00407537|141271930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.94|||<|0.001|TWO_SIDED|95.0|-43.71|-34.17||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||TC||-34.17|-43.71|<0.001
70892867|NCT00407537|141271930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-35.31|||<|0.001|TWO_SIDED|95.0|-39.64|-30.99||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||LDL||-30.99|-39.64|<0.001
70892868|NCT00407537|141271930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.99||||0.087|TWO_SIDED|95.0|-0.14|2.13||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|mixed-effect linear model|||HDL||2.13|-0.14|0.087
70892869|NCT00407537|141271930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-23.65|||<|0.001|TWO_SIDED|95.0|-32.6|-14.7||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||Triglycerides||-14.70|-32.60|<0.001
70892870|NCT00407537|141271931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-33.07|||<|0.001|TWO_SIDED|95.0|-37.57|-28.56||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||Total cholesterol||-28.56|-37.57|<0.001
70892871|NCT00407537|141271931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-29.83|||<|0.001|TWO_SIDED|95.0|-33.7|-25.95||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||LDL||-25.95|-33.70|<0.001
70892872|NCT00407537|141271931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.58||||0.379|TWO_SIDED|95.0|-0.71|1.86||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|mixed-effect linear model|||HDL||1.86|-0.71|0.379
70892873|NCT00407537|141271931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.27|||<|0.001|TWO_SIDED|95.0|-28.72|-7.81||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||Triglycerides||-7.81|-28.72|<0.001
70892874|NCT00782340|141271989|SUPERIORITY_OR_OTHER|||||||0.003||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|ANCOVA|ANCOVA model that includes treatment as a factor and baseline OHQ composite score as a co-variate.||||||0.003
70892875|NCT00782340|141271990|SUPERIORITY_OR_OTHER|||||||0.003||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|ANCOVA|ANCOVA model that includes treatment as a factor and baseline OHDAS composite score as a co-variate.||||||0.003
70892876|NCT00782340|141271991|SUPERIORITY_OR_OTHER|||||||0.01||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|ANCOVA|ANCOVA model including a factor for randomized treatment along with the OHSA composite value at randomization as a covariate.||||||0.010
70892877|NCT00782340|141271992|SUPERIORITY_OR_OTHER|||||||0.003||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at baseline.||||||0.003
70892878|NCT00782340|141271993|SUPERIORITY_OR_OTHER|||||||0.009||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|ANCOVA|ANCOVA model including a factor for randomized treatment along with the OHSA composite value at randomization as a covariate.||||||0.009
70892879|NCT00782340|141271994|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at baseline.||||||<0.001
70892880|NCT00782340|141271995|SUPERIORITY_OR_OTHER|||||||0.327||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors. As the this endpoint was not positive, no additional statistical analyses will be performed on secondary endpoints.|Fisher Exact|||||||0.327
70892881|NCT02219932|141272003|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.006|TWO_SIDED|95.0|1.15|2.26|||Regression, Logistic||fampridine vs. placebo|Based on logistic regression, adjusting for baseline MSWS-12 score, baseline TUG speed, age, screening Expanded Disability Status Scale (EDSS) score and prior aminopyridine. Missing data handled by multiple imputation. Hypothesis testing was performed at the 2-sided 5% significance level overall, with adjustment for testing multiple secondary endpoints.||2.26|1.15|0.006
70892882|NCT02219932|141272003|SUPERIORITY_OR_OTHER||Risk Difference for Adjusted Proportions|0.104|||||TWO_SIDED|95.0|0.03|0.178||||||Based on logistic regression, adjusting for baseline MSWS-12 score, baseline TUG speed, age, screening Expanded Disability Status Scale (EDSS) score and prior aminopyridine. Missing data handled by multiple imputation. Hypothesis testing was performed at the 2-sided 5% significance level overall, with adjustment for testing multiple secondary endpoints.||0.178|0.030|
70892883|NCT02219932|141272003|SUPERIORITY_OR_OTHER||Relative Risk|1.38|||||TWO_SIDED|95.0|1.06|1.7||||||Based on logistic regression, adjusting for baseline MSWS-12 score, baseline TUG speed, age, screening Expanded Disability Status Scale (EDSS) score and prior aminopyridine. Missing data handled by multiple imputation. Hypothesis testing was performed at the 2-sided 5% significance level overall, with adjustment for testing multiple secondary endpoints.||1.70|1.06|
70892884|NCT02219932|141272004|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.03|TWO_SIDED|95.0|1.04|2.07|||Regression, Logistic|||Based on logistic regression, adjusting for baseline TUG speed, screening EDSS score and prior aminopyridine. Missing data were handled using multiple imputation.||2.07|1.04|0.030
70892885|NCT02219932|141272004|SUPERIORITY_OR_OTHER||Risk Difference for Adjusted Proportions|0.092|||||TWO_SIDED|95.0|0.009|0.175||||||Based on logistic regression, adjusting for baseline TUG speed, screening EDSS score and prior aminopyridine. Missing data were handled using multiple imputation.||0.175|0.009|
70892886|NCT02219932|141272004|SUPERIORITY_OR_OTHER||Relative Risk|1.25|||||TWO_SIDED|95.0|0.99|1.51||||||Based on logistic regression, adjusting for baseline TUG speed, screening EDSS score and prior aminopyridine. Missing data were handled using multiple imputation.||1.51|0.99|
70892887|NCT02219932|141272005|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.31|STANDARD_ERROR_OF_MEAN|0.925|<|0.001|TWO_SIDED|95.0|-5.13|-1.5|||mixed model for repeated measures|||||-1.50|-5.13|< 0.001
70892888|NCT02219932|141272006|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.277||0.141|TWO_SIDED|95.0|-0.13|0.95|||mixed model for repeated measures|||||0.95|-0.13|0.141
70892889|NCT02219932|141272007|SUPERIORITY_OR_OTHER||LS Mean Difference|0.74|STANDARD_ERROR_OF_MEAN|0.573||0.197|TWO_SIDED|95.0|-0.38|1.86|||mixed model for repeated measures|||||1.86|-0.38|0.197
70892890|NCT01866410|141272014|OTHER|||||||0.4|||||||Log Rank|||||||0.4
70892891|NCT01866410|141272015|OTHER|||||||0.5|||||||Log Rank|||||||0.5
70892892|NCT00366626|141272025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92|STANDARD_DEVIATION|6.32||0.51|TWO_SIDED|95.0|-1.85|3.69|||ANOVA|||This was a 2 gene (asn40asn vs 40asp) by two medication (naltrexone vs placebo) design. The main hypothesis was that the effect of naltrexone (mean naltrexone drinking - placebo drinking) would be greater in the 40asp subjects than in the asn40asn subjects. Thus the null hypothesis there would be no gene by medication interaction. The mean difference above is then the difference in the size of the naltrexone effect in the two genotypes, equivalent to the interaction.||3.69|-1.85|0.51
70892893|NCT00366626|141272026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46|STANDARD_DEVIATION|6.1||0.28|TWO_SIDED|95.0|-1.22|4.11|||ANOVA|||This was a 2 gene (asn40asn vs 40asp) by 2 medication (naltrexone vs. placebo)interaction analysis. The main hypothesis was that subjects who had 40asp OPRM1 allele would a greater naltrexone effect on drinking (Placebo - Naltrexxone) than the asn40asn subjects. Thus the null hypothesis was the gene by medication interaction.||4.11|-1.22|0.28
70892894|NCT04313634|141272052|SUPERIORITY|||||||0.611|||||||Wilcoxon (Mann-Whitney)|||||||0.611
70892895|NCT04313634|141272053|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
70892896|NCT04313634|141272054|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||||||0.024
70892897|NCT04313634|141272055|SUPERIORITY|||||||0.149|||||||Wilcoxon (Mann-Whitney)|||||||0.149
70892898|NCT04313634|141272057|SUPERIORITY|||||||0.953|||||||Wilcoxon (Mann-Whitney)|||||||0.953
70892899|NCT00167544|141272060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4|||<|0.05|TWO_SIDED|95.0|-19.49|30.29|||ANCOVA|||The primary analysis of total brain tissue volume was performed using multiple linear regression controlling for postmenstrual age at MRI scan to adjust for differences in timing at MRI. The distributions of potentially important confounding variables at baseline were compared in the two groups using parametric and non-parametric tests as appropriate. All analyses were performed using STATA 11.0. Please see PubMed: 23140612.||30.29|-19.49|<0.05
70892900|NCT02830594|141272072|EQUIVALENCE|Specifically, a sample-size of 14 patients will have 80% power to detect an effect size of 0.71 using a paired t-test with a 0.05 one-sided significance level. The effect size is the mean difference divided by the standard deviation of the difference.||||||0.6|||||||Paired t Test|||||||0.60
70892901|NCT02830594|141272073|EQUIVALENCE|Specifically, a sample-size of 14 patients will have 80% power to detect an effect size of 0.71 using a paired t-test with a 0.05 one-sided significance level. The effect size is the mean difference divided by the standard deviation of the difference.||||||0.87|||||||Paired t Test|||||||0.87
70892902|NCT02830594|141272074|EQUIVALENCE|Specifically, a sample-size of 14 patients will have 80% power to detect an effect size of 0.71 using a paired t-test with a 0.05 one-sided significance level. The effect size is the mean difference divided by the standard deviation of the difference.||||||0.64|||||||Paired t Test|||||||0.64
70892903|NCT01764945|141272079|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|82.58|STANDARD_DEVIATION|19.7|||TWO_SIDED|90.0|73.69|92.54|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment B : treatment A)."||92.54|73.69|
70892904|NCT01764945|141272079|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|83.34|STANDARD_DEVIATION|22.2|||TWO_SIDED|90.0|73.65|94.3|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment C : treatment A)."||94.30|73.65|
70892905|NCT01764945|141272079|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|83.92|STANDARD_DEVIATION|19.6|||TWO_SIDED|90.0|74.69|94.28|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment D : treatment A)."||94.28|74.69|
70963600|NCT04427501|141432102|SUPERIORITY||Odds Ratio (OR)|1.88|||||TWO_SIDED|95.0|1.22|2.9||||||||2.9|1.22|
70963601|NCT04427501|141432103|SUPERIORITY||Odds Ratio (OR)|0.34|||||TWO_SIDED|95.0|0.18|0.64||||||||0.64|0.18|
70892906|NCT01764945|141272079|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|92.9|STANDARD_DEVIATION|10.5|||TWO_SIDED|90.0|88.94|97.04|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment F : treatment E)."||97.04|88.94|
70892907|NCT01764945|141272079|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|96.37|STANDARD_DEVIATION|12.7|||TWO_SIDED|90.0|91.55|101.43|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment G : treatment E)."||101.43|91.55|
70892908|NCT01764945|141272079|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|94.44|STANDARD_DEVIATION|12.0|||TWO_SIDED|90.0|89.88|99.24|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment H : treatment E)."||99.24|89.88|
70892909|NCT01764945|141272080|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|74.07|STANDARD_DEVIATION|21.5|||TWO_SIDED|90.0|65.44|83.83|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment B : treatment A)."||83.83|65.44|
70892910|NCT01764945|141272080|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|73.23|STANDARD_DEVIATION|26.2|||TWO_SIDED|90.0|63.33|84.68|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment C : treatment A)."||84.68|63.33|
70892911|NCT01764945|141272080|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|78.76|STANDARD_DEVIATION|22.7|||TWO_SIDED|90.0|68.94|89.99|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment D : treatment A)."||89.99|68.94|
70892912|NCT01764945|141272080|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|78.3|STANDARD_DEVIATION|22.5|||TWO_SIDED|90.0|71.42|85.84|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment F : treatment E)."||85.84|71.42|
70892913|NCT01764945|141272080|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|78.43|STANDARD_DEVIATION|30.4|||TWO_SIDED|90.0|69.54|88.46|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment G : treatment E)."||88.46|69.54|
70892914|NCT01764945|141272080|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|78.09|STANDARD_DEVIATION|29.4|||TWO_SIDED|90.0|69.35|87.94|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment H : treatment E)."||87.94|69.35|
70892915|NCT01764945|141272081|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|82.02|STANDARD_DEVIATION|13.1|||TWO_SIDED|90.0|75.98|88.55|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment B : treatment A)."||88.55|75.98|
70892916|NCT01764945|141272081|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|80.93|STANDARD_DEVIATION|14.5|||TWO_SIDED|90.0|74.58|87.83|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment C : treatment A)."||87.83|74.58|
70892917|NCT01764945|141272081|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|79.6|STANDARD_DEVIATION|10.2|||TWO_SIDED|90.0|74.84|84.67|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment D : treatment A)."||84.67|74.84|
70892918|NCT01764945|141272081|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|91.59|STANDARD_DEVIATION|11.0|||TWO_SIDED|90.0|87.53|95.84|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment F : treatment E)."||95.84|87.53|
70892919|NCT01764945|141272081|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|94.38|STANDARD_DEVIATION|12.4|||TWO_SIDED|90.0|89.76|99.24|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment G : treatment E)."||99.24|89.76|
70892920|NCT01764945|141272081|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|92.91|STANDARD_DEVIATION|12.0|||TWO_SIDED|90.0|88.42|97.63|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment H : treatment E)."||97.63|88.42|
70892921|NCT02911948|141272085|SUPERIORITY|Superiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was strictly below 0.0% for null hypothesis (H0): D=0.0% against the alternative (HA): D≠0.0%, where D is the mean difference (IDegLira - IDeg).|Treatment contrast|-1.28|||<|0.0001|TWO_SIDED|95.0|-1.5|-1.06|||ANCOVA|||The response and change from baseline in response after 26 weeks are analysed using an ANCOVA model with treatment and pre-trial anti-diabetic treatment as fixed factors and corresponding baseline HbA1c value as covariate.||-1.06|-1.50|<0.0001
70892922|NCT02005471|141272149|SUPERIORITY||Hazard Ratio (HR)|0.23|||<|0.0001|TWO_SIDED|95.0|0.18|0.29|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified analysis: 17p deletion, risk status, geographic region.||0.29|0.18|<.0001
70892923|NCT02005471|141272149|SUPERIORITY||Hazard Ratio (HR)|0.25|||<|0.0001|TWO_SIDED|95.0|0.19|0.31|||Log Rank||Hazard ratio was estimated by Cox regression model|Unstratified Analysis||0.31|0.19|<.0001
70892924|NCT02005471|141272151|SUPERIORITY||Hazard Ratio (HR)|0.19|||<|0.0001|TWO_SIDED|95.0|0.13|0.28|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factors: 17p deletion, risk status, geographic region.||0.28|0.13|<.0001
70892925|NCT02005471|141272151|SUPERIORITY||Hazard Ratio (HR)|0.2|||<|0.0001|TWO_SIDED|95.0|0.14|0.3|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||0.30|0.14|<.0001
70892926|NCT02005471|141272153|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.0001|TWO_SIDED|95.0|0.21|0.57|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factor: geographic region.||0.57|0.21|<.0001
70892927|NCT02005471|141272153|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.0001|TWO_SIDED|95.0|0.22|0.56|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||0.56|0.22|<.0001
70892928|NCT02005471|141272155|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.09|0.49|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factor: geographic region.||0.49|0.09|<.0001
70892929|NCT02005471|141272155|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.09|0.46|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||0.46|0.09|<.0001
70892930|NCT02005471|141272156|SUPERIORITY||Difference in Response Rates|25.61|||<|0.0001|TWO_SIDED|95.0|17.88|33.33|||Cochran-Mantel-Haenszel||95% CI for rates were constructed using Pearson- Clopper method. 95% CI for difference in rates were constructed using Anderson-Hauck method.|||33.33|17.88|<.0001
70892931|NCT02005471|141272156|SUPERIORITY||Odds Ratio (OR)|7.81|||||TWO_SIDED|95.0|3.97|15.37|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.|||15.37|3.97|
70892932|NCT02005471|141272157|SUPERIORITY||Difference in Response Rates|25.61|||<|0.0001|TWO_SIDED|95.0|17.88|33.33|||Cochran-Mantel-Haenszel||95% CI for rates were constructed using Pearson- Clopper method. 95% CI for difference in rates were constructed using Anderson-Hauck method.|||33.33|17.88|<.0001
70892933|NCT02005471|141272157|SUPERIORITY||Odds Ratio (OR)|7.81|||||TWO_SIDED|95.0|3.97|15.37|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.|||15.37|3.97|
70892934|NCT02005471|141272158|SUPERIORITY||Difference in Response Rates|25.07|||<|0.0001|TWO_SIDED|95.0|16.63|33.51|||Cochran-Mantel-Haenszel||The 95% CI was computed using Anderson-Hauck method.|||33.51|16.63|<.0001
70892935|NCT02005471|141272158|SUPERIORITY||Odds Ratio (OR)|4.59|||||TWO_SIDED|95.0|2.68|7.88|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.|||7.88|2.68|
70892936|NCT02005471|141272159|SUPERIORITY||Difference in Response Rates|24.55|||<|0.0001|TWO_SIDED|95.0|16.0|33.1|||Cochran-Mantel-Haenszel||The 95% CI was computed using Anderson-Hauck method.|||33.10|16.00|<.0001
70892937|NCT02005471|141272159|SUPERIORITY||Odds Ratio (OR)|4.59|||||TWO_SIDED|95.0|2.68|7.85|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.|||7.85|2.68|
70892938|NCT02005471|141272161|SUPERIORITY|Stratified Analysis; Stratification factors: 17p deletion, risk status, geographic region.|Hazard Ratio (HR)|0.53||||0.0002|TWO_SIDED|95.0|0.37|0.74|||Log Rank||Hazard ratio was estimated by Cox regression model.|||0.74|0.37|0.0002
70892939|NCT02005471|141272161|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.0003|TWO_SIDED|95.0|0.39|0.76|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||0.76|0.39|0.0003
70892940|NCT02005471|141272163|SUPERIORITY||Hazard Ratio (HR)|0.22|||<|0.0001|TWO_SIDED|95.0|0.17|0.29|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factors: 17p deletion, risk status, geographic region.||0.29|0.17|<.0001
70892941|NCT02005471|141272163|SUPERIORITY||Hazard Ratio (HR)|0.25|||<|0.0001|TWO_SIDED|95.0|0.19|0.31|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||0.31|0.19|<.0001
70892942|NCT02005471|141272167|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.23|0.39|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factors: 17p deletion, risk status, geographic region.||0.39|0.23|<.0001
70892943|NCT02005471|141272167|SUPERIORITY||Hazard Ratio (HR)|0.32|||<|0.0001|TWO_SIDED|95.0|0.25|0.41|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||0.41|0.25|<.0001
70892944|NCT02005471|141272168|SUPERIORITY||Difference in MRD Negativity Rates|49.04|||<|0.0001|TWO_SIDED|95.0|40.44|57.64|||Chi-squared||The 95% CI was computed using Anderson-Hauck method.|||57.64|40.44|<.0001
70892945|NCT02005471|141272168|SUPERIORITY||Odds Ratio (OR)|10.77|||||TWO_SIDED|95.0|6.5|17.85|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.|||17.85|6.50|
70892946|NCT02005471|141272169|SUPERIORITY||Difference in MRD negative rates|13.41|||<|0.0001|TWO_SIDED|95.0|7.99|18.82|||Chi-squared||The 95% CI was computed using Anderson-Hauck method.|||18.82|7.99|<.0001
70892947|NCT02005471|141272169|SUPERIORITY||Odds Ratio (OR)|16.28|||||TWO_SIDED|95.0|3.82|69.35|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.|||69.35|3.82|
70892948|NCT00932893|141272193|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.487|||<|0.0001||95.0|0.371|0.638||To control family-wise Type 1 error, a step-down procedure was applied in following order: PFS, objective response rate (ORR), overall survival (OS), and disease control rate (DCR). Statistical significance: 1-sided at alpha=0.025.|Log Rank|||P-value was obtained from 1-sided log-rank test stratified by Eastern Cooperative Oncology Group performance status (ECOG PS) score, brain metastases, and prior epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) treatment. The hazard ratio and corresponding 95% confidence interval (CI) from the stratified Cox Proportional Hazards model were also presented.||0.638|0.371|<0.0001
70892949|NCT00932893|141272194|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.854||||0.1145||95.0|0.661|1.104||Statistical significance: 1-sided at alpha=0.025|Log Rank|||P-value was obtained from 1-sided log-rank test stratified by ECOG PS score, brain metastases, and prior EGFR TKI treatment. The hazard ratio and corresponding 95% CI from the stratified Cox proportional hazards model were also presented.||1.104|0.661|0.1145
70963602|NCT04427501|141432103|SUPERIORITY||Odds Ratio (OR)|0.17|||||TWO_SIDED|95.0|0.07|0.38||||||||0.38|0.07|
70892950|NCT00932893|141272196|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.394|||<|0.0001||95.0|2.463|4.676||Statistical significance: 2-sided at alpha=0.025.|Cochran-Mantel-Haenszel|||P-value was obtained from Cochran-Mantel-Haenszel (CMH) test stratified by ECOG PS, brain metastases, and prior EGFR TKI treatment. The risk ratio and corresponding 95% CI from the stratified CMH test were also reported.||4.676|2.463|<0.0001
70892951|NCT00932893|141272197|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.502|||<|0.0001||95.0|1.297|1.741||Statistical significance: 2-sided at alpha=0.0004.|Cochran-Mantel-Haenszel|||P-value was obtained from CMH test stratified by ECOG PS, brain metastases, and prior EGFR TKI treatment. The risk ratio and corresponding 95% CI from the stratified CMH test were also reported.||1.741|1.297|<0.0001
70892952|NCT00932893|141272198|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.697|||<|0.0001|TWO_SIDED|95.0|1.368|2.103||Statistical significance: 2-sided at alpha=0.0004.|Cochran-Mantel-Haenszel|||P-value was obtained from CMH test stratified by ECOG PS, brain metastases, and prior EGFR TKI treatment. The risk ratio and corresponding 95% CI from the stratified CMH test were also reported.||2.103|1.368|<0.0001
70892953|NCT00932893|141272204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.497|||<|0.0001||95.0|0.373|0.661|||Log Rank|||The p-value was obtained from 2-sided unstratified log-rank test. The hazard ratio and corresponding 95% CI from the Cox Proportional Hazards model were also presented.||0.661|0.373|<0.0001
70892954|NCT04295564|141272216|SUPERIORITY||Mean Difference (Final Values)|82.1|||<|0.05|TWO_SIDED|95.0|8.3|155.9||This is a calculate p value|Mixed Models Analysis|adjusted for the correlation between twin pairs and gestational age at birth (stratification variable), sex, and length at outpatient testing||||155.9|8.3|<0.05
70892955|NCT04295564|141272217|SUPERIORITY||Mean Difference (Final Values)|0.6|||<|0.02|TWO_SIDED|95.0|0.1|1.1||This is a calculated p value|Mixed Models Analysis|Adjusted for correlation between twin pairs and gestational age at birth (stratification variable), sex, and length at outpatient test.||||1.1|0.1|<0.02
70892956|NCT04295564|141272218|SUPERIORITY||Mean Difference (Final Values)|62.7|||<|0.05|TWO_SIDED|95.0|4.5|121.0||This is a calculated p value|Mixed Models Analysis|P-value adjusted for correlation between twin pairs and gestational age at birth (stratification variable), sex, and length at outpatient testing.||||121|4.5|<0.05
70892957|NCT04295564|141272219|SUPERIORITY||Odds Ratio (OR)|0.59|||>|0.05|TWO_SIDED|95.0|0.27|1.31||This is a calculated p value|Regression, Logistic|||||1.31|0.27|>0.05
70892958|NCT04295564|141272219|SUPERIORITY||Odds Ratio (OR)|0.59|||>|0.05|TWO_SIDED|95.0|0.27|1.31|||Regression, Logistic|Adjusted for gestational age at birth (stratification variable)||||1.31|0.27|>0.05
70892959|NCT05349617|141272238|SUPERIORITY||Percent Difference|86.2|||<|0.0001|TWO_SIDED|95.0|80.0|90.3||p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups. Both coprimary endpoints were required to be met for success, so no multiple comparisons were performed.|Chi-squared||Seroresponse rate difference is (PXVX0317 minus placebo).|Day 22||90.3|80|<0.0001
70892960|NCT05349617|141272239|SUPERIORITY||[GMT Ratio]|90.0|||<|0.0001|TWO_SIDED|95.0|69.0|117.0||Both coprimary endpoints were required to be met for success, so no multiple comparisons were performed.|ANOVA|ANOVA model covers site and treatment group as fixed effects, assuming log titers' normality. p-value tests equivalence of mean titers between groups.|Ratio of GMTs is (PXVX0317:placebo).|Day 22||117|69|<0.0001
70892961|NCT05349617|141272245|SUPERIORITY||Percent Difference|79.5|||<|0.0001|TWO_SIDED|95.0|72.3|84.6||Key secondary endpoints were tested hierarchically (Day 15 tested prior to Day 183), such that each was only tested if both coprimary endpoints and prior key secondary endpoints were met, so no multiple comparisons were performed|Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|Day 15||84.6|72.3|<0.0001
70892962|NCT05349617|141272245|SUPERIORITY||Percent Difference|74.4|||<|0.0001|TWO_SIDED|95.0|67.1|80.1||Key secondary endpoints were tested hierarchically (Day 15 tested prior to Day 183), such that each was only tested if both coprimary endpoints and prior key secondary endpoints were met, so no multiple comparisons were performed|Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|Day 183||80.1|67.1|<0.0001
70892963|NCT05349617|141272246|SUPERIORITY||[GMT Ratio]|42.0|||<|0.0001|TWO_SIDED|95.0|32.0|56.0|||ANOVA|ANOVA model covers site and treatment group as fixed effects, assuming log titers' normality. p-value tests equivalence of mean titers between groups.|Ratio of GMTs is (PXVX0317:placebo)|Day 15||56|32|<0.0001
70892964|NCT05349617|141272246|SUPERIORITY||[GMT Ratio]|28.0|||<|0.0001|TWO_SIDED|95.0|22.0|35.0|||ANOVA|ANOVA model covers site and treatment group as fixed effects, assuming log titers' normality. p-value tests equivalence of mean titers between groups.|Ratio of GMTs is (PXVX0317:placebo)|Day 183||35|22|<0.0001
70892965|NCT05349617|141272247|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95 percent CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 15||||<0.0001
70892966|NCT05349617|141272247|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95 percent CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 22||||<0.0001
70892967|NCT05349617|141272247|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95 percent CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 183||||<0.0001
70892968|NCT05349617|141272248|SUPERIORITY||Percent Difference|91.6|||<|0.0001|TWO_SIDED|95.0|86.0|94.6|||Chi-squared|p-value is from a two-sided chi-square test of equality of SNA response percentages between groups.|SNA response rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 15||94.6|86.0|<0.0001
70892969|NCT05349617|141272248|SUPERIORITY||Percent Difference|94.1|||<|0.0001|TWO_SIDED|95.0|89.2|96.5|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 22||96.5|89.2|<0.0001
70892970|NCT05349617|141272248|SUPERIORITY||Percent Difference|91.8|||<|0.0001|TWO_SIDED|95.0|86.3|94.8|||Chi-squared|p-value is from a two-sided chi-square test of equality of SNA response percentages between groups.|SNA response rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 183||94.8|86.3|<0.0001
70963603|NCT04427501|141432103|SUPERIORITY||Odds Ratio (OR)|0.25|||||TWO_SIDED|95.0|0.06|1.05||||||||1.05|0.06|
70892971|NCT05349617|141272248|SUPERIORITY||Percent Difference|82.8|||<|0.0001|TWO_SIDED|95.0|75.9|87.5||p-value is from a two-sided chi-square test of equality of SNA response percentages between groups.|Chi-squared||SNA response rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 15||87.5|75.9|<0.0001
70892972|NCT05349617|141272248|SUPERIORITY||Percent Difference|88.3|||<|0.0001|TWO_SIDED|95.0|82.4|92.0|||Chi-squared|p-value is from a two-sided chi-square test of equality of SNA response percentages between groups.|SNA response rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 22||92.0|82.4|<0.0001
70892973|NCT05349617|141272248|SUPERIORITY||Percent Difference|82.0|||<|0.0001|TWO_SIDED|95.0|75.2|86.8|||Chi-squared|p-value is from a two-sided chi-square test of equality of SNA response percentages between groups.|SNA response rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 183||86.8|75.2|<0.0001
70892974|NCT01928719|141272254|OTHER||Hazard Ratio (HR)|3.3|||<|0.0001|TWO_SIDED|95.0|1.95|5.58|||Regression, Cox||The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|||5.58|1.95|<0.0001
70892975|NCT01928719|141272255|OTHER||Hazard Ratio (HR)|3.4|||<|0.0001|TWO_SIDED|95.0|1.99|5.81||Testing the effect of treatment group in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Age Group, Working Status, and BMI.|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|The reference group is Same Nicotine Content Group.||5.81|1.99|<0.0001
70892976|NCT01928719|141272255|OTHER||Hazard Ratio (HR)|0.51||||0.06|TWO_SIDED|95.0|0.26|1.03||Testing the effect of age group (ages 30-39) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and BMI.|The direction of comparison is Age group 30-39 to the Age group 18-29.|The reference group is Age equals 18-29.||1.03|0.26|0.06
70892977|NCT01928719|141272255|OTHER||Hazard Ratio (HR)|0.33|||<|0.002|TWO_SIDED|95.0|0.17|0.66||Testing the effect of age group (ages 40-49) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and BMI.|The direction of comparison is Age group 40-49 to the Age group 18-29.|The reference group is Age equals 18-29.||0.66|0.17|<0.002
70892978|NCT01928719|141272255|OTHER||Hazard Ratio (HR)|0.33|||<|0.002|TWO_SIDED|95.0|0.16|0.65||Testing the effect of age group (Ages 50-59) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and BMI.|The direction of comparison is Age group 50-59 to Age group 18-29.|The reference group is Age equals 18-29.||0.65|0.16|<0.002
70892979|NCT01928719|141272255|OTHER||Hazard Ratio (HR)|0.39||||0.1|TWO_SIDED|95.0|0.13|1.18||Testing the effect of age group (Ages 60-65) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and BMI.|The direction of comparison is Age group 60-65 to the Age group 18-29.|The reference group is Age equals 18-29.||1.18|0.13|0.1
70892980|NCT01928719|141272255|OTHER||Hazard Ratio (HR)|1.6||||0.1|TWO_SIDED|95.0|0.92|2.66||Testing the effect of working status in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Age, and BMI.||The reference group is not currently working.|The direction of comparison is currently working to not currently working.|2.66|0.92|0.1
70892981|NCT01928719|141272255|OTHER||Hazard Ratio (HR)|0.25||||0.006|TWO_SIDED|95.0|0.1|0.67||Testing the effect of BMI Normal Weight group (\>=18.5 \& \<25) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and Age.|The direction of comparison is Normal Weight (\>=18.5 \& \<25) to Underweight (\<18.5) group.|The reference group is BMI Underweight (\<18.5)||0.67|0.1|0.006
70892982|NCT01928719|141272255|OTHER||Hazard Ratio (HR)|0.35||||0.034|TWO_SIDED|95.0|0.13|0.92||Testing the effect of BMI Overweight group (\>=25 \& \< 30) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and Age.|The direction of comparison is Overweight (\>=25 \& \< 30) to Underweight (\<18.5) group.|The reference group is BMI Underweight group (\<18.5)||0.92|0.13|0.034
70892983|NCT01928719|141272255|OTHER||Hazard Ratio (HR)|0.31||||0.011|TWO_SIDED|95.0|0.13|0.77||Testing the effect of BMI Obese group (\>=30) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and Age.|The direction of comparison is Obese (\>=30) to Underweight (\<18.5) group.|The reference group is BMI Underweight group (\<18.5)||0.77|0.13|0.011
70892984|NCT01928719|141272256|OTHER||Least Squares Mean Difference|-4.1||||0.0006|TWO_SIDED|95.0|-6.44|-1.75|||Mixed Models Analysis|The model included time, group, and time-by-group interaction; treating baseline scores for outcomes as covariates|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|||-1.75|-6.44|0.0006
70892985|NCT01928719|141272257|OTHER||Least Squares Mean Difference|-136.7|||<|0.0001|TWO_SIDED|95.0|-171.7|-101.7|||Mixed Models Analysis|The model included time, group, and time-by-group interaction; treating baseline scores for outcomes as covariates|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|||-101.7|-171.7|<.0001
70892986|NCT01928719|141272258|OTHER||Least Squares Mean Difference|-4.03||||0.0305|TWO_SIDED|95.0|-7.68|-0.38|||Mixed Models Analysis|The model included time, group, and time-by-group interaction; treating baseline scores for outcomes as covariates|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|||-0.38|-7.68|0.0305
70892987|NCT01928719|141272259|OTHER||Least Squares Mean Difference|1.81||||0.0207|TWO_SIDED|95.0|0.28|3.33|||Mixed Models Analysis|The model included time, group, and time-by-group interaction; treating baseline scores for outcomes as covariates|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|||3.33|0.28|0.0207
70892988|NCT01928719|141272260|OTHER||Least Squares Mean Difference|-0.16||||0.4191|TWO_SIDED|95.0|-0.56|0.23|||Mixed Models Analysis|The model included time, group, and time-by-group interaction; treating baseline scores for outcomes as covariates|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|||0.23|-0.56|0.4191
70892989|NCT02250612|141272261|SUPERIORITY|||||||0.93|||||||ANCOVA|||||||0.93
70892990|NCT02250612|141272261|SUPERIORITY|||||||0.92|||||||ANCOVA|||||||0.92
70892991|NCT02250612|141272261|SUPERIORITY|||||||0.23|||||||ANCOVA|||||||0.23
70892992|NCT02250612|141272261|SUPERIORITY|||||||0.85|||||||ANCOVA|||||||0.85
70892993|NCT02250612|141272261|SUPERIORITY|||||||0.25|||||||ANCOVA|||||||0.25
70892994|NCT02250612|141272261|SUPERIORITY|||||||0.18|||||||ANCOVA|||||||0.18
70892995|NCT02250612|141272262|SUPERIORITY|||||||0.94|||||||ANCOVA|||||||0.94
70892996|NCT02250612|141272262|SUPERIORITY|||||||0.38|||||||ANCOVA|||||||0.38
70892997|NCT02250612|141272262|SUPERIORITY|||||||0.85|||||||ANCOVA|||||||0.85
70892998|NCT02250612|141272262|SUPERIORITY|||||||0.412|||||||ANCOVA|||||||0.412
70892999|NCT02250612|141272262|SUPERIORITY|||||||0.79|||||||ANCOVA|||||||0.79
70893000|NCT02250612|141272262|SUPERIORITY|||||||0.28|||||||ANCOVA|||||||0.28
70893001|NCT05732454|141272264|SUPERIORITY||Difference in percentage|-3.76|||=|0.558|TWO_SIDED|95.0|-16.36|8.83|||Cochran-Mantel-Haenszel|||Normal approximation adjusting for the stratification factor (disease severity as measured by baseline IGA score 3 \[moderate\], 4 \[severe\]) derived from clinical database via Cochran-Mantel-Haenszel (CMH) approach was used.||8.83|-16.36|=0.5580
70893002|NCT05732454|141272265|SUPERIORITY||Difference in percentage|9.07|||=|0.3685|TWO_SIDED|95.0|-10.7|28.85|||Cochran-Mantel-Haenszel|||Normal approximation adjusting for the stratification factor (disease severity as measured by baseline IGA score 3 \[moderate\], 4 \[severe\]) derived from clinical database via Cochran-Mantel-Haenszel (CMH) approach was used.||28.85|-10.70|=0.3685
70893003|NCT05732454|141272266|SUPERIORITY||Difference in Mean|-29.22|||=|0.0303|TWO_SIDED|95.0|-55.53|-2.9|||Rubin's rule|||Jump-to-Control (JTC) method was used for evaluation. A complete imputed dataset was analyzed using analysis of covariance model including effects of treatment group, actual stratification factor, and baseline value. Multiple results of the treatment comparison were combined using Rubin's rules, reporting the combined treatment difference, its standard error, 95% CI and 2-sided p-value, across the visits.||-2.90|-55.53|=0.0303
70893004|NCT00377819|141272292|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.35%|Mean Difference (Final Values)|0.85|||<|0.0001||95.0|0.44|1.25|||Repeated Measures Model||Based on repeated measures model adjusting for treatment, length of prior alendronate stratification variable, visit, baseline value, machine type, treatment by visit interaction, and baseline value by machine type interaction|||1.25|0.44|<0.0001
70893005|NCT00377819|141272293|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.22%|Mean Difference (Final Values)|1.18|||<|0.0001||95.0|0.63|1.73|||Repeated Measures Model||Based on repeated measures model adjusting for treatment, length of prior alendronate stratification variable, visit, baseline value, machine type, treatment by visit interaction, and baseline value by machine type interaction|||1.73|0.63|<0.0001
70893006|NCT00377819|141272294|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Van Elteren Stratified Rank Test|||||||<0.0001
70893007|NCT00823719|141272350|SUPERIORITY_OR_OTHER||percentage of participants|69.0|||||TWO_SIDED|95.0|48.2|85.7|||||The estimated value represents the percentage of participants with OR for participants receiving Ofatumumab + DHAP treatment.|||85.7|48.2|
70893008|NCT00823719|141272350|SUPERIORITY_OR_OTHER||percentage of participants|55.0|||||TWO_SIDED|95.0|36.4|71.9|||||The estimated value represents the percentage of participants with OR for participants receiving Ofatumumab + ICE treatment.|||71.9|36.4|
70893009|NCT00823719|141272350|SUPERIORITY_OR_OTHER||percentage of participants|61.0|||||TWO_SIDED|95.0|47.4|73.5|||||The estimated value represents the percentage of participants with OR for participants receiving Total Ofatumumab + Chemotherapy treatment.|||73.5|47.4|
70893010|NCT01380327|141272386|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.7||||0.001|TWO_SIDED|95.0|1.2|2.3|||Mixed Models Analysis||Estimated value \& associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.18) vs. high dose group (numerator=1.98).|Analysis compared cockroach SLIT -high dose, Placebo - high dose||2.3|1.2|0.001
70893011|NCT01380327|141272386|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.3|||<|0.0001|TWO_SIDED|95.0|1.7|3.1|||Mixed Models Analysis||Estimated value \& associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.18) vs. low dose group (numerator=2.69).|Analysis compared cockroach SLIT - low dose, placebo - low dose||3.1|1.7|<0.0001
70893012|NCT01380327|141272387|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3|||<|0.0001|TWO_SIDED|95.0|1.1|1.4|||Mixed Models Analysis||Estimated value \& associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.04) vs. high dose group (numerator=1.32).|Analysis compared cockroach SLIT - high dose, placebo - high dose||1.4|1.1|<0.0001
70893013|NCT01380327|141272387|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.11|TWO_SIDED|95.0|1.0|1.2|||Mixed Models Analysis||Estimated value \& associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.04) vs. low dose group (numerator=1.14).|Analysis compared cockroach SLIT - low dose, placebo - low dose||1.2|1.0|0.11
70893014|NCT01380327|141272388|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.5||||0.06|TWO_SIDED|95.0|1.0|2.4|||Mixed Models Analysis||Estimated value and associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.03) vs. high dose group (numerator=1.57).|Analysis compared cockroach SLIT - high dose, placebo - high dose||2.4|1.0|0.06
70893015|NCT01380327|141272388|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.4||||0.13|TWO_SIDED|95.0|0.9|2.2|||Mixed Models Analysis||Estimated value \& associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.03) vs. low dose group (numerator=1.45).|Analysis compared cockroach SLIT - low dose, placebo - low dose||2.2|0.9|0.13
70893016|NCT01380327|141272389|SUPERIORITY_OR_OTHER||Treatment effect|-12.9||||0.21|TWO_SIDED|95.0|-33.2|7.5|||Mixed Models Analysis||Estimated value\& associated CI is the treatment effect: baseline to post-baseline change in measurement in high dose group (-7.2) minus baseline to post-baseline change in measurement in placebo group (5.7) .|Analysis compared cockroach SLIT - high dose, placebo - high dose||7.5|-33.2|0.21
70893017|NCT01380327|141272389|SUPERIORITY_OR_OTHER||Treatment effect|13.5||||0.2|TWO_SIDED|95.0|-7.1|34.1|||Mixed Models Analysis||Estimated value\& associated CI is the treatment effect: baseline to post-baseline change in measurement in high dose group (19.2) minus baseline to post-baseline change in measurement in placebo group (5.7) .|Analysis compared cockroach SLIT - low dose, placebo - low dose||34.1|-7.1|0.20
70893018|NCT01136291|141272411|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||The homogeneity between the groups was compared by the Student's t test or the Mann-Whitney test for continuous variables and chi-square for categorical variables.A comparison between values before and after the study group session was performed by the Student's t test. The effect of the exercise was evaluated by repeated measures ANOVA, where the effect of time and group were evaluated on pressure, weight, Body Mass Index (BMI)and World Health Organization Quality of Life Questionnarie domains.||||<0.05
70893019|NCT02308033|141272418|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||||||<0.001
70893020|NCT02308033|141272419|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||||||<0.001
70893021|NCT02308033|141272420|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||Comparison of normal Nugent scores at 7-14 days||||<0.001
70893022|NCT02308033|141272421|SUPERIORITY|||||||0.034|||||||Chi-squared, Corrected|||Comparison of the number of subjects whose reported their symptoms completely resolved||||0.034
70893023|NCT04773015|141272429|OTHER|||||||0.6371|||||||Fisher Exact|||||||0.6371
70893024|NCT04773015|141272430|OTHER|||||||0.1448|||||||Fisher Exact|||||||0.1448
70893025|NCT04773015|141272431|OTHER|||||||0.1507|||||||Fisher Exact|||||||0.1507
70893026|NCT04773015|141272432|OTHER|||||||0.1189|||||||Fisher Exact|||||||0.1189
70893027|NCT03021187|141272444|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.3||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 3mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment, strata, interaction strata and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.3|-0.7|< 0.0001
70893028|NCT03021187|141272444|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 7 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.7|-1.1|< 0.0001
70893029|NCT03021187|141272444|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.4|-1.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-1.0|-1.4|< 0.0001
70893030|NCT03021187|141272444|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.4||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 3 mg - Placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and interaction strata as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.4|-0.7|<0.0001
70893031|NCT03021187|141272444|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 7 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and the interaction strata as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.8|-1.2|<0.0001
70893032|NCT03021187|141272444|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.2||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and the interaction strata as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.2|-1.6|<0.0001
70893033|NCT03021187|141272445|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.9||||0.0392|TWO_SIDED|95.0|-1.8|0.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 3 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.0|-1.8|0.0392
70963604|NCT04427501|141432104|SUPERIORITY||Mean Difference (Net)|-1.2|||<|0|TWO_SIDED|95.0|-1.46|-0.94|||Mixed Models Analysis|||||-0.94|-1.46|<0.0000000
70893034|NCT03021187|141272445|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-2.0||||0.0001|TWO_SIDED|95.0|-3.0|-1.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 7 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-1.0|-3.0|0.0001
70893035|NCT03021187|141272445|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-3.3|||<|0.0001|TWO_SIDED|95.0|-4.2|-2.3||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-2.3|-4.2|<0.0001
70893036|NCT03021187|141272445|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.9||||0.0111|TWO_SIDED|95.0|-1.6|-0.2||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 3 mg - Placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and interaction strata as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.2|-1.6|0.0111
70893037|NCT03021187|141272445|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.8||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 7 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and the interaction strata as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.8|-3.2|<0.0001
70893038|NCT03021187|141272445|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-3.7|||<|0.0001|TWO_SIDED|95.0|-4.4|-3.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and the interaction strata as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-3.0|-4.4|<0.0001
70893039|NCT03021187|141272465|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.73||||0.0627|TWO_SIDED|95.0|0.53|1.02||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.02|0.53|0.0627
70893040|NCT03021187|141272465|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.63||||0.0083|TWO_SIDED|95.0|0.44|0.89||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.89|0.44|0.0083
70893041|NCT03021187|141272465|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.57||||0.0019|TWO_SIDED|95.0|0.4|0.81||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.81|0.40|0.0019
70893042|NCT03021187|141272466|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.75||||0.121|TWO_SIDED|95.0|0.53|1.08||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||1.08|0.53|0.1210
70963605|NCT04427501|141432104|SUPERIORITY||Mean Difference (Net)|-1.09|||<|0|TWO_SIDED|95.0|-1.34|-0.85|||Mixed Models Analysis|||||-0.85|-1.34|<0.0000000
70893043|NCT03021187|141272466|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.48||||0.0007|TWO_SIDED|95.0|0.32|0.74||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.74|0.32|0.0007
70893044|NCT03021187|141272466|SUPERIORITY||Hazard Ratio (HR)|0.48||||0.0006|TWO_SIDED|95.0|0.31|0.73||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.73|0.31|0.0006
70893045|NCT01664078|141272481|OTHER|The Intent-to-Treat (ITT) analysis set includes all subjects who had the aortic bifurcate device introduced into the body. This ITT analysis set will be used for all safety and clinical assessment endpoints.||||||0.47|||||||Mixed Models Analysis|||||||0.47
70893046|NCT00718718|141272494|SUPERIORITY_OR_OTHER|||||||0.026|||||||Cochran-Mantel-Haenszel|||||||0.026
70893047|NCT00718718|141272494|SUPERIORITY_OR_OTHER|||||||0.052|||||||Cochran-Mantel-Haenszel|||||||0.052
70893048|NCT00718718|141272494|SUPERIORITY_OR_OTHER|||||||0.026|||||||Cochran-Mantel-Haenszel|||||||0.026
70893049|NCT00718718|141272494|SUPERIORITY_OR_OTHER|||||||0.104|||||||Cochran-Mantel-Haenszel|||||||0.104
70893050|NCT00718718|141272495|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Van Der Waerden ANOVA|||||||< 0.001
70893051|NCT00718718|141272495|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Van Der Waerden ANOVA|||||||< 0.001
70893052|NCT00718718|141272495|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Van Der Waerden ANOVA|||||||< 0.001
70893053|NCT00718718|141272495|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Van Der Waerden ANOVA|||||||< 0.001
70893054|NCT00718718|141272495|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Van Der Waerden ANOVA|||||||< 0.001
70893055|NCT00718718|141272496|SUPERIORITY_OR_OTHER|||||||0.148|||||||Cochran-Mantel-Haenszel|||||||0.148
70893056|NCT01462344|141272511|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority comparison was statistically significant if the upper bound of the two-sided 95% CI falls below 2.675, the non-inferiority margin, and the non-inferiority test one-sided p-value \<0.025.|Hazard Ratio (HR)|1.285||||0.006|TWO_SIDED|95.0|0.726|2.272|||Regression, Cox||Estimated for Hazard ratio|||2.272|0.726|0.006
70893057|NCT01462344|141272511|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0019|||||TWO_SIDED|95.0|-0.0024|0.0063|||||Estimated for Absolute risk difference|||0.0063|-0.0024|
70893058|NCT01462344|141272512|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.859|||||TWO_SIDED|95.0|0.729|1.012|||||Estimated for Hazard ratio|||1.012|0.729|
70893059|NCT02276482|141272555|OTHER||Difference in percentages|3.6|||||TWO_SIDED|95.0|-6.3|13.5|||||The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.|||13.5|-6.3|
70893060|NCT02276482|141272556|OTHER||Difference in percentages|3.7|||||TWO_SIDED|95.0|-3.4|10.8|||||The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.|||10.8|-3.4|
70893061|NCT02276482|141272557|OTHER||Difference in percentages|-4.2|||||TWO_SIDED|95.0|-12.9|4.4|||||The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.|||4.4|-12.9|
70893062|NCT02276482|141272558|OTHER||Difference in percentages|0.2|||||TWO_SIDED|95.0|-7.4|7.7|||||The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.|||7.7|-7.4|
70893063|NCT02276482|141272559|OTHER||Difference in percentages|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.|||0.0|0.0|
70893064|NCT01165281|141272564|NON_INFERIORITY_OR_EQUIVALENCE|In order to demonstrate that the upper limit of the confidence interval of intergroup differences in change from baseline is not higher than the noninferiority margin of 1 with a 1-tailed significance level of 0.025 and 90% power, the sample size was calculated to be 133 patients in each group for a total of 266 patients. Assuming approximately 20% of patients would be excluded from the analyses, the target sample size was 330 patients.|Least-Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.226||0.786|TWO_SIDED|95.0|-0.506|0.383|||ANCOVA|Analysis of covariance (ANCOVA) model was used with treatment and country as factors and baseline pain intensity score as a covariate.||The primary hypothesis to be tested for the study was that the JNS024 ER group was not inferior to oxycodone CR as defined by the upper limit of the 95% confidence interval of the difference between JNS024 ER and oxycodone CR on the mean change from baseline of the NRS pain intensity score during the last 3 days of study drug administration. It was to be concluded that JNS024 ER is not inferior to oxycodone CR if the upper 95% confidence limit is less than 1 point.||0.383|-0.506|0.786
70893065|NCT02730819|141272594|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||P-values of 0.05 or lower were considered statistically significant.||||0.006
70893066|NCT02730819|141272595|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||P-values of 0.05 or lower were considered statistically significant.||||0.006
70893067|NCT02099006|141272627|SUPERIORITY_OR_OTHER|||||||0.3|||||||t-test, 2 sided|Paired T test||Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of loperamide than with the daily application of a placebo cream.||||0.30
70893068|NCT02099006|141272627|SUPERIORITY_OR_OTHER|||||||0.33|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of ketamine than with the daily application of a placebo cream.||||0.33
70893069|NCT02099006|141272627|SUPERIORITY_OR_OTHER|||||||0.65|||||||t-test, 2 sided|paired||Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of gabapentin than with the daily application of a placebo cream.||||0.65
70893070|NCT02099006|141272627|SUPERIORITY_OR_OTHER|||||||0.25|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of amitriptyline and baclofen than with the daily application of a placebo cream.||||0.25
70893071|NCT02099006|141272627|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of ketoprofen than with the daily application of a placebo cream.||||1.0
70893072|NCT02099006|141272628|SUPERIORITY_OR_OTHER|||||||0.31|||||||t-test, 2 sided|paired||Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of loperamide cream than with the daily application of a placebo cream.||||0.31
70893073|NCT02099006|141272628|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of ketamine cream than with the daily application of a placebo cream.||||1
70893074|NCT02099006|141272628|SUPERIORITY_OR_OTHER|||||||0.66|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of gabapentin cream than with the daily application of a placebo cream.||||0.66
70893075|NCT02099006|141272628|SUPERIORITY_OR_OTHER|||||||0.42|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of ketoprofen cream than with the daily application of a placebo cream.||||0.42
70893076|NCT02099006|141272628|SUPERIORITY_OR_OTHER|||||||0.79|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of amitriptyline/baclofen cream than with the daily application of a placebo cream.||||0.79
70893077|NCT00809757|141272639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||||TWO_SIDED|95.0|-1.412|0.342|||||Difference is Placebo MDI minus Levalbuterol UDV|195 subjects were randomized in order to achieve 150 subjects completing the study. The sample size was set based on FDA requirements, and was outside of statistical considerations.||0.342|-1.412|
70893078|NCT00809757|141272639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|||||TWO_SIDED|95.0|-1.714|0.335|||||Difference is Levalbuterol UDV minus Levalbuterol MDI|195 subjects were randomized in order to achieve 150 subjects completing the study. The sample size was set based on FDA requirements, and was outside of statistical considerations||0.335|-1.714|
70893079|NCT00809757|141272639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|||||TWO_SIDED|95.0|-1.08|0.771|||||Difference is Levalbuterol UDV minus Levalbuterol MDI|195 subjects were randomized in order to achieve 150 subjects completing the study. The sample size was set based on FDA requirements, and was outside of statistical considerations.||0.771|-1.080|
70893080|NCT01410448|141272675|SUPERIORITY_OR_OTHER|||||||0.0921|||||||Regression, Logistic|||||||0.0921
70893081|NCT01308580|141272692|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 1.214|Hazard Ratio (HR)|1.024|||||ONE_SIDED|98.89||1.184|||||Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2|The hazard ratio for OS was estimated using the Cox proportional hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization. Cabazitaxel 20 mg/m\^2 relative to 25 mg/m\^2 dose group was considered non-inferior if the upper bound of 1-sided 98.89% confidence interval of hazard ratio (20 mg/m\^2 versus 25 mg/m\^2) was less than the non-inferiority margin of 1.214.||1.184||
70893082|NCT01308580|141272692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.024|||||ONE_SIDED|95.0|0.922||||||Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2|The hazard ratio for OS was estimated using the Cox proportional hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization. Cabazitaxel 25 mg/m\^2 was considered to be superior to 20 mg/m\^2 dose if the lower bound of 1-sided 95% confidence interval of hazard ratio was greater than 1.|||0.922|
70893083|NCT01308580|141272693|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.099|||||TWO_SIDED|95.0|0.974|1.24|||||Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization.||1.24|0.974|
70893084|NCT01308580|141272694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.096|||||TWO_SIDED|95.0|0.902|1.331|||||Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization.||1.331|0.902|
70893085|NCT01308580|141272696|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.195|||||TWO_SIDED|95.0|1.025|1.393|||||Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization.||1.393|1.025|
70893086|NCT01308580|141272698|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.046|||||TWO_SIDED|95.0|0.874|1.251|||||Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2|Hazard ratio is estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization.||1.251|0.874|
70893087|NCT00360529|141272710|SUPERIORITY_OR_OTHER|||||||0.0454||95.0||||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|Wilcoxon (Mann-Whitney)|||Flibanserin 50 mg qhs versus placebo||||0.0454
70893088|NCT00360529|141272710|SUPERIORITY_OR_OTHER|||||||0.0024||95.0||||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|Wilcoxon (Mann-Whitney)|||Flibanserin 100 mg qhs versus placebo||||0.0024
70893089|NCT00360529|141272711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.2606||95.0|-1.0|3.7||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 50 mg qhs versus placebo||3.7|-1.0|0.2606
70893090|NCT00360529|141272711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2||||0.066||95.0|-0.1|4.6|||ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 100 mg qhs versus placebo||4.6|-0.1|0.066
70893091|NCT00360529|141272712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.1601||95.0|-2.9|0.5||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 50 mg qhs versus placebo||0.5|-2.9|0.1601
70963606|NCT04427501|141432104|SUPERIORITY||Mean Difference (Net)|-0.99||||3.777e-05|TWO_SIDED|95.0|-1.45|-0.52|||Mixed Models Analysis|||||-0.52|-1.45|0.00003777
70893092|NCT00360529|141272712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9||||0.0001||95.0|-5.6|-2.2||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 100 mg qhs versus placebo||-2.2|-5.6|0.0001
70893093|NCT00360529|141272713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.1144||95.0|-0.3|0.0||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 50 mg qhs versus placebo||0.0|-0.3|0.1144
70893094|NCT00360529|141272713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.0001||95.0|-0.5|-0.2||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 100 mg qhs versus placebo||-0.2|-0.5|0.0001
70893095|NCT00360529|141272714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.0173||95.0|0.0|0.4|||ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 50 mg qhs versus placebo||0.4|0.0|0.0173
70893096|NCT00360529|141272714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.0001||95.0|0.2|0.5|||ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 100 mg qhs versus placebo||0.5|0.2|0.0001
70893097|NCT00360529|141272715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.0071||95.0|0.4|2.6|||ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 50 mg qhs versus placebo||2.6|0.4|0.0071
70893098|NCT00360529|141272715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.0001||95.0|1.4|3.6|||ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 100 mg qhs versus placebo||3.6|1.4|0.0001
70893099|NCT00360529|141272716|SUPERIORITY_OR_OTHER||Percentage responders|34.7||||0.0513||95.0|29.0|40.4|||Cochran-Mantel-Haenszel|Model includes treatment and centre||Flibanserin 25 mg bid versus placebo||40.4|29.0|0.0513
70893100|NCT00360529|141272716|SUPERIORITY_OR_OTHER||Percentage responders|38.6||||0.0059||95.0|32.6|44.6|||Cochran-Mantel-Haenszel|Model includes treatment and centre||Flibanserin 50 mg qhs versus placebo||44.6|32.6|0.0059
70893101|NCT01218438|141272719|SUPERIORITY_OR_OTHER_LEGACY||Poisson|0.012|||<|0.0001|ONE_SIDED|99.0||0.024|||Poisson|||||0.024||<0.0001
70893102|NCT05437510|141272819|SUPERIORITY||Efficacy|84.04|||<|0.0001|TWO_SIDED|95.0|69.493|92.411|||Exact method using binomial distribution|||The 2-sided 95% confidence interval (CI) for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.||92.411|69.493|<0.0001
70893103|NCT05437510|141272820|SUPERIORITY||Efficacy|77.71||||0.0014|TWO_SIDED|95.0|39.249|93.432|||Exact method using binomial distribution|||The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of very severe RSV LRTI in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.||93.432|39.249|0.0014
70893104|NCT05437510|141272821|SUPERIORITY||Efficacy|90.7|||<|0.0001|TWO_SIDED|95.0|63.676|98.813||Adjusted p-value is reported.|Exact method using binomial distribution|||Statistical analysis for France: The adjusted 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization. Adjustment based on Bonferroni-Holm procedure.||98.813|63.676|<0.0001
70893105|NCT05437510|141272821|SUPERIORITY||Efficacy|83.2||||0.0036|TWO_SIDED|95.0|33.589|97.593||Adjusted p-value is reported.|Exact method using binomial distribution|||Statistical analysis for UK: The adjusted 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization. Adjustment based on Bonferroni-Holm procedure.||97.593|33.589|0.0036
70893106|NCT05437510|141272821|SUPERIORITY||Efficacy|74.62||||0.0051|TWO_SIDED|95.0|29.74|92.595||Adjusted p-value is reported.|Exact method using binomial distribution|||Statistical analysis for Germany: The adjusted 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization. Adjustment based on Bonferroni-Holm procedure.||92.595|29.740|0.0051
70893107|NCT05437510|141272822|SUPERIORITY||Efficacy|57.97|||<|0.0001|TWO_SIDED|95.0|40.36|70.76|||Exact method using binomial distribution|||"Statistical analysis for Overall:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of all-cause LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||70.760|40.360|<0.0001
70893108|NCT05437510|141272822|SUPERIORITY||Efficacy|52.48||||0.0039|TWO_SIDED|95.0|20.121|72.36|||Exact method using binomial distribution|||"Statistical analysis for France:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of all-cause LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||72.360|20.121|0.0039
70893109|NCT05437510|141272822|SUPERIORITY||Efficacy|58.62||||0.0024|TWO_SIDED|95.0|25.115|78.049|||Exact method using binomial distribution|||"Statistical analysis for UK:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of all-cause LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||78.049|25.115|0.0024
70893110|NCT05437510|141272822|SUPERIORITY||Efficacy|70.74||||0.0037|TWO_SIDED|95.0|29.567|89.396|||Exact method using binomial distribution|||"Statistical analysis for Germany:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of all-cause LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||89.396|29.567|0.0037
70963607|NCT04427501|141432105|SUPERIORITY||Hazard Ratio (HR)|1.213||||0.007|TWO_SIDED||||||Stratified Log-rank|||||||0.007
70893111|NCT05437510|141272823|SUPERIORITY||Efficacy|82.44|||<|0.0001|TWO_SIDED|95.0|67.271|91.357|||Exact method using binomial distribution|||"Statistical analysis for Overall:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||91.357|67.271|<0.0001
70893112|NCT05437510|141272823|SUPERIORITY||Efficacy|86.11|||<|0.0001|TWO_SIDED|95.0|60.283|96.459|||Exact method using binomial distribution|||"Statistical analysis for France:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||96.459|60.283|<0.0001
70893113|NCT05437510|141272823|SUPERIORITY||Efficacy|85.2||||0.0004|TWO_SIDED|95.0|50.084|97.183|||Exact method using binomial distribution|||"Statistical analysis for UK:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||97.183|50.084|0.0004
70893114|NCT05437510|141272823|SUPERIORITY||Efficacy|74.36||||0.0055|TWO_SIDED|95.0|29.006|92.518|||Exact method using binomial distribution|||"Statistical analysis for Germany:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||92.518|29.006|0.0055
70893115|NCT05437510|141272824|SUPERIORITY||Efficacy|75.31||||0.0013|TWO_SIDED|95.0|38.012|91.747|||Exact method using binomial distribution|||"Statistical analysis for Overall:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of very severe RSV LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||91.747|38.012|0.0013
70893116|NCT05437510|141272824|SUPERIORITY||Efficacy|78.1||||0.062|TWO_SIDED|95.0|-5.823|97.697|||Exact method using binomial distribution|||"Statistical analysis for France:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of very severe RSV LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||97.697|-5.823|0.0620
70893117|NCT05437510|141272824|SUPERIORITY||Efficacy|91.01||||0.006|TWO_SIDED|95.0|38.156|99.791|||Exact method using binomial distribution|||"Statistical analysis for UK:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of very severe RSV LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||99.791|38.156|0.0060
70893118|NCT05437510|141272824|SUPERIORITY||Efficacy|26.01||||0.9851|TWO_SIDED|95.0|-337.329|89.162|||Exact method using binomial distribution|||"Statistical analysis for Germany:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of very severe RSV LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||89.162|-337.329|0.9851
70893119|NCT05437510|141272825|SUPERIORITY||Efficacy|43.62|||<|0.0001|TWO_SIDED|95.0|24.677|58.057|||Exact method using binomial distribution|||"Statistical analysis for Overall:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||58.057|24.677|<0.0001
70893120|NCT05437510|141272825|SUPERIORITY||Efficacy|34.78||||0.0754|TWO_SIDED|95.0|-4.148|59.648|||Exact method using binomial distribution|||"Statistical analysis for France:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||59.648|-4.148|0.0754
70893121|NCT05437510|141272825|SUPERIORITY||Efficacy|40.67||||0.0177|TWO_SIDED|95.0|8.211|62.156|||Exact method using binomial distribution|||"Statistical analysis for UK:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||62.156|8.211|0.0177
70893122|NCT05437510|141272825|SUPERIORITY||Efficacy|66.38||||0.0046|TWO_SIDED|95.0|25.952|86.137|||Exact method using binomial distribution|||"Statistical analysis for Germany:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||86.137|25.952|0.0046
70893123|NCT05437510|141272830|SUPERIORITY||Efficacy|82.72|||<|0.0001|TWO_SIDED|95.0|67.826|91.49|||Exact method using binomial distribution|||"Statistical analysis for Overall:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations through Day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||91.490|67.826|<0.0001
70893124|NCT05437510|141272830|SUPERIORITY||Efficacy|86.13|||<|0.0001|TWO_SIDED|95.0|60.34|96.464|||Exact method using binomial distribution|||"Statistical analysis for France:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations through Day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||96.464|60.340|<0.0001
70893125|NCT05437510|141272830|SUPERIORITY||Efficacy|85.92||||0.0002|TWO_SIDED|95.0|52.85|97.311|||Exact method using binomial distribution|||"Statistical analysis for UK:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations through Day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||97.311|52.850|0.0002
70893126|NCT05437510|141272830|SUPERIORITY||Efficacy|74.39||||0.0054|TWO_SIDED|95.0|29.077|92.525|||Exact method using binomial distribution|||"Statistical analysis for Germany:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations through Day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||92.525|29.077|0.0054
70893127|NCT05437510|141272831|SUPERIORITY||Efficacy|41.89|||<|0.0001|TWO_SIDED|95.0|23.073|56.333|||Exact method using binomial distribution|||"Statistical analysis for Overall:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||56.333|23.073|<0.0001
70893128|NCT05437510|141272831|SUPERIORITY||Efficacy|32.19||||0.1003|TWO_SIDED|95.0|-7.188|57.545|||Exact method using binomial distribution|||"Statistical analysis for France:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||57.545|-7.188|0.1003
70893129|NCT05437510|141272831|SUPERIORITY||Efficacy|39.83||||0.0164|TWO_SIDED|95.0|8.449|60.911|||Exact method using binomial distribution|||"Statistical analysis for UK:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||60.911|8.449|0.0164
70893130|NCT05437510|141272831|SUPERIORITY||Efficacy|64.06||||0.0058|TWO_SIDED|95.0|23.386|84.478|||Exact method using binomial distribution|||"Statistical analysis for Germany:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||84.478|23.386|0.0058
70893131|NCT01914926|141272865|NON_INFERIORITY_OR_EQUIVALENCE|Chi-Square test||||||0.0001||95.0|||||Chi-squared|||We estimated a sample size of 200 patients assigned in a 1:1 ratio to receive diltiazem and metoprolol would achieve 80% power to detect non-inferiority using a one-sided two sample t-test. The margin of equivalence is -10.||||.0001
70893132|NCT00321919|141272901|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.778976||||0.2036|TWO_SIDED|95.0|0.53|1.14|||Regression, Cox||The Cox regression model was used to estimate the relative risk of the time to first cardiovascular event in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy group.|The null hypothesis stated that there was no difference with regard to the event-free distribution of the combined endpoint of all protocol specified cardiovascular events between Early Epoetin beta therapy and Late Epoetin beta therapy groups.||1.14|0.53|0.2036
70893133|NCT00321919|141272902|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.744575||||0.4833|TWO_SIDED|95.0|0.33|1.7|||Regression, Cox||The Cox regression model was used to estimate the relative risk of an event of the time to death due to cardiovascular reasons in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy group.|||1.70|0.33|0.4833
70893134|NCT00321919|141272904|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.658259||||0.1391|TWO_SIDED|95.0|0.38|1.15|||Regression, Cox||The Cox regression model was used to estimate the relative risk of the time to death for all causes in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy treatment group.|||1.15|0.38|0.1391
70893135|NCT00321919|141272907|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.804594||||0.4985|TWO_SIDED|95.0|0.43|1.51|||Regression, Cox||The Cox regression model was used to estimate the relative risk of time to first cardiovascular intervention in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy group|||1.51|0.43|0.4985
70893136|NCT00321919|141272909|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.82046||||0.3419|TWO_SIDED|95.0|0.55|1.23|||Regression, Cox||The Cox regression model was used to estimate the relative risk of the time to first hospitalization for cardiovascular reasons in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy group.|||1.23|0.55|0.3419
70893137|NCT00321919|141272916|SUPERIORITY_OR_OTHER|||||||0.0029|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of General health scale of Quality of life for Year 1.||||0.0029
70893138|NCT00321919|141272916|SUPERIORITY_OR_OTHER|||||||0.0081|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of General health scale of Quality of life for Year 2||||0.0081
70893139|NCT00321919|141272916|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Mental health scale of Quality of life for Year 1||||0.0005
70893140|NCT00321919|141272916|SUPERIORITY_OR_OTHER|||||||0.0965|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Mental Health scale of Quality of life for Year 2||||0.0965
70893141|NCT00321919|141272916|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Physical function scale of Quality of life for Year 1||||0.0004
70893142|NCT00321919|141272916|SUPERIORITY_OR_OTHER|||||||0.9864|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Physical function scale of Quality of life for Year 2||||0.9864
70893143|NCT00321919|141272916|SUPERIORITY_OR_OTHER|||||||0.0097|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Physical Role scale of Quality of life for Year 1||||0.0097
70893144|NCT00321919|141272916|SUPERIORITY_OR_OTHER|||||||0.167|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Physical Role scale of Quality of life for Year 2||||0.1670
70893145|NCT00321919|141272916|SUPERIORITY_OR_OTHER|||||||0.0058|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Social function scale of Quality of life for Year 1||||0.0058
70893146|NCT00321919|141272916|SUPERIORITY_OR_OTHER|||||||0.1455|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Social function scale of Quality of life for Year 2||||0.1455
70893147|NCT00321919|141272916|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Vitality function scale of Quality of life for Year 1||||0.0009
70893148|NCT00321919|141272916|SUPERIORITY_OR_OTHER|||||||0.0123|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Vitality function scale of Quality of life for Year 2||||0.0123
70893149|NCT00321919|141272916|SUPERIORITY_OR_OTHER|||||||0.3155|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Bodily pain scale of Quality of life for Year 1||||0.3155
70893150|NCT00321919|141272916|SUPERIORITY_OR_OTHER|||||||0.7076|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Bodily pain scale of Quality of life for Year 2||||0.7076
70893151|NCT00321919|141272916|SUPERIORITY_OR_OTHER|||||||0.1291|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Emotional role scale of Quality of life for Year 1||||0.1291
70893152|NCT00321919|141272916|SUPERIORITY_OR_OTHER|||||||0.5528|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Emotional role scale of Quality of life for Year 2||||0.5528
70893153|NCT00760929|141272927|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.4301||90.0|0.58|1.21|||Wald Test|||||1.21|0.58|0.4301
70893154|NCT00760929|141272927|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.0342||90.0|0.42|0.9|||Wald Test|||||0.90|0.42|0.0342
70893155|NCT02099838|141272931|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HbA1c between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||<0.0001
70893156|NCT02099838|141272931|SUPERIORITY_OR_OTHER|||||||0.065||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HbA1c between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.0650
70893157|NCT02099838|141272931|SUPERIORITY_OR_OTHER|||||||0.0005||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HbA1c between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.0005
70893158|NCT02099838|141272932|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of FPG between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||<0.0001
70893159|NCT02099838|141272932|SUPERIORITY_OR_OTHER|||||||0.0849||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of FPG between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.0849
70893160|NCT02099838|141272932|SUPERIORITY_OR_OTHER|||||||0.0005||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of FPG between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.0005
70893161|NCT02099838|141272933|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2hPPG between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||<0.0001
70893162|NCT02099838|141272933|SUPERIORITY_OR_OTHER|||||||0.2428||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2hPPG between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.2428
70893163|NCT02099838|141272933|SUPERIORITY_OR_OTHER|||||||0.0003||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2hPPG between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.0003
70893164|NCT02099838|141272934|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of fasting insulin between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||<0.0001
70893165|NCT02099838|141272934|SUPERIORITY_OR_OTHER|||||||0.7353||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of fasting insulin between before and after treatment in Placebo group.. The test was performed with a significance level of 0.05.||||0.7353
70893166|NCT02099838|141272934|SUPERIORITY_OR_OTHER|||||||0.0013||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of fasting insulin between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.0013
70893167|NCT02099838|141272935|SUPERIORITY_OR_OTHER|||||||0.1147||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2-hour postprandial insulin between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.1147
70893168|NCT02099838|141272935|SUPERIORITY_OR_OTHER|||||||0.4006||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2-hour postprandial insulin between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.4006
70893169|NCT02099838|141272935|SUPERIORITY_OR_OTHER|||||||0.0614||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2-hour postprandial insulin between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.0614
70963608|NCT04427501|141432105|SUPERIORITY||Hazard Ratio (HR)|1.111||||0.13|TWO_SIDED||||||Stratified Log-rank|||||||0.130
70963609|NCT04427501|141432105|SUPERIORITY||Hazard Ratio (HR)|1.38||||0.012|TWO_SIDED||||||Stratified Log-rank|||||||0.012
70893170|NCT02099838|141272936|SUPERIORITY_OR_OTHER|||||||0.3795||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TC between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.3795
70893171|NCT02099838|141272936|SUPERIORITY_OR_OTHER|||||||0.4236||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TC between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.4236
70893172|NCT02099838|141272936|SUPERIORITY_OR_OTHER|||||||1||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TC between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||1.0000
70893173|NCT02099838|141272937|SUPERIORITY_OR_OTHER|||||||0.3151||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TG between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.3151
70893174|NCT02099838|141272937|SUPERIORITY_OR_OTHER|||||||0.6963||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TG between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.6963
70893175|NCT02099838|141272937|SUPERIORITY_OR_OTHER|||||||0.3204||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TG between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.3204
70893176|NCT02099838|141272938|SUPERIORITY_OR_OTHER|||||||0.0038||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HDL between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.0038
70893177|NCT02099838|141272938|SUPERIORITY_OR_OTHER|||||||0.3812||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HDL between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.3812
70893178|NCT02099838|141272938|SUPERIORITY_OR_OTHER|||||||0.0108||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HDL between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.0108
70893179|NCT02099838|141272939|SUPERIORITY_OR_OTHER|||||||0.5476||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of LDL between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.5476
70893180|NCT02099838|141272939|SUPERIORITY_OR_OTHER|||||||0.1248||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of LDL between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.1248
70893181|NCT02099838|141272939|SUPERIORITY_OR_OTHER|||||||0.362||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of LDL between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.3620
70893182|NCT02099838|141272940|SUPERIORITY_OR_OTHER|||||||0.5636||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of ALT between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.5636
70893183|NCT02099838|141272940|SUPERIORITY_OR_OTHER|||||||0.3681||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of ALT between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.3681
70893184|NCT02099838|141272940|SUPERIORITY_OR_OTHER|||||||0.2589||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of ALT between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.2589
70893185|NCT02099838|141272941|SUPERIORITY_OR_OTHER|||||||0.7972||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of AST between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.7972
70893186|NCT02099838|141272941|SUPERIORITY_OR_OTHER|||||||0.7801||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of AST between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.7801
70893187|NCT02099838|141272941|SUPERIORITY_OR_OTHER|||||||0.8744||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of AST between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.8744
70893188|NCT02099838|141272942|SUPERIORITY_OR_OTHER|||||||0.8034||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of DBil between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.8034
70893189|NCT02099838|141272942|SUPERIORITY_OR_OTHER|||||||0.7675||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TBil between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.7675
70893190|NCT02099838|141272942|SUPERIORITY_OR_OTHER|||||||0.6918||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TBil between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.6918
70893191|NCT02099838|141272943|SUPERIORITY_OR_OTHER|||||||0.0339||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of DBil between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.0339
70893192|NCT02099838|141272943|SUPERIORITY_OR_OTHER|||||||0.0997||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of DBil between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.0997
70893193|NCT02099838|141272943|SUPERIORITY_OR_OTHER|||||||0.5015||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of DBil between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.5015
70893194|NCT03740490|141272956|SUPERIORITY||Mean Difference (Net)|-0.1||||0.284|TWO_SIDED|95.0|-0.28|0.08|||Mixed Models Analysis|||Each outcome was modeled using a mixed-effects regression with the change score as the dependent variable and treatment group (Smart-T vs. QuitGuide) as the predictor, restricted to participants who received or would have received that type of message.||0.08|-0.28|0.284
70893195|NCT03740490|141272957|SUPERIORITY||Mean Difference (Net)|0.06||||0.477|TWO_SIDED|95.0|-0.11|0.24|||Mixed Models Analysis|||||0.24|-0.11|0.477
70893196|NCT03740490|141272958|SUPERIORITY||Mean Difference (Net)|0.03||||0.456|TWO_SIDED|95.0|-0.05|0.1|||Mixed Models Analysis|||||0.10|-0.05|0.456
70893197|NCT03740490|141272959|SUPERIORITY||Mean Difference (Net)|-0.22||||0.215|TWO_SIDED|95.0|-0.56|0.13|||Mixed Models Analysis|||||0.13|-0.56|0.215
70893198|NCT00434057|141272983|SUPERIORITY_OR_OTHER||Sensitivity to melanoma|98.0||||0.05||95.0|95.1|100.0|||exact mid-P||"Of 127 melanomas, 114 melanomas had a pre-biopsy diagnosis of Melanoma can not be ruled out or Not melanoma, which qualified them for primary endpoint analysis of sensitivity. MelaFind correctly identified 112/114 melanomas."|MelaFind's sensitivity to cutaneous melanoma and 95% confidence intervals were determined.||100|95.1|0.05
70893199|NCT00434057|141272983|SUPERIORITY_OR_OTHER|||||||0.02|||||||Chi-squared|||Specificty of MelaFind and examining dermatologists on the same set of pigmented skin lesions.||||0.02
70893200|NCT02585895|141273033|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|74.2|||<|0.0001|TWO_SIDED|95.0|44.6|86.8|||Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel (CMH) test stratified by screening LDL-C level|Treatment difference used apheresis as the reference.|||86.8|44.6|< 0.0001
70893201|NCT02585895|141273034|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-52.74|STANDARD_ERROR_OF_MEAN|5.64|<|0.0001|TWO_SIDED|95.0|-64.18|-41.3|||Repeated measures linear effects model|Model included treatment group, screening LDL-C level, scheduled visit, and the interaction of treatment group with scheduled visit as covariates.|Treatment difference used apheresis as the reference.|||-41.30|-64.18|< 0.0001
70893202|NCT02585895|141273035|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-46.37|STANDARD_ERROR_OF_MEAN|4.67|<|0.0001|TWO_SIDED|95.0|-55.85|-36.9|||Repeated measures linear effects model|Model included treatment group, screening LDL-C level, scheduled visit, and the interaction of treatment group with scheduled visit as covariates.|Treatment difference used apheresis as the reference.|||-36.90|-55.85|< 0.0001
70893203|NCT02585895|141273036|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-35.8|STANDARD_ERROR_OF_MEAN|3.74|<|0.0001|TWO_SIDED|95.0|-43.39|-28.21|||Repeated measures linear effects model|Model included treatment group, screening LDL-C level, scheduled visit, and the interaction of treatment group with scheduled visit as covariates.||||-28.21|-43.39|< 0.0001
70893204|NCT03836287|141273051|OTHER||Odds Ratio (OR)|2.34||||0.0004|TWO_SIDED|95.0|1.47|3.72|||Regression, Logistic|||||3.72|1.47|0.0004
70893205|NCT03836287|141273052|OTHER||Mean Difference (Net)|-29.71|STANDARD_ERROR_OF_MEAN|9.543||0.0019|TWO_SIDED|95.0|-48.42|-11.0|||ANCOVA|||||-11.00|-48.42|0.0019
70893206|NCT00833989|141273067|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.45|STANDARD_ERROR_OF_MEAN|0.231|||TWO_SIDED|95.0|-0.03|0.92|||Mixed Model Repeated Measure Analysis||Mean difference = GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 4||0.92|-0.03|
70893207|NCT00833989|141273067|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.69|STANDARD_ERROR_OF_MEAN|0.214|||TWO_SIDED|95.0|0.25|1.13|||Mixed Model Repeated Measure Analysis||Mean difference = GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 4||1.13|0.25|
70893208|NCT00833989|141273067|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.246|||TWO_SIDED|95.0|-0.2|0.8|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 4||0.80|-0.20|
70893209|NCT00833989|141273067|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.292|||TWO_SIDED|95.0|-0.24|0.95|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 5||0.95|-0.24|
70893210|NCT00833989|141273067|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.52|STANDARD_ERROR_OF_MEAN|0.279|||TWO_SIDED|95.0|-0.05|1.09|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 5 mg/kg- Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 5||1.09|-0.05|
70893211|NCT00833989|141273067|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.319|||TWO_SIDED|95.0|-0.61|0.69|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 5||0.69|-0.61|
70893212|NCT00833989|141273067|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.63|STANDARD_ERROR_OF_MEAN|0.235|||TWO_SIDED|95.0|0.15|1.11|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 6||1.11|0.15|
70893213|NCT00833989|141273067|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.225|||TWO_SIDED|95.0|-0.06|0.86|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 6||0.86|-0.06|
70893214|NCT00833989|141273067|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.259|||TWO_SIDED|95.0|-0.29|0.77|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 6||0.77|-0.29|
70893215|NCT00833989|141273067|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.61|STANDARD_ERROR_OF_MEAN|0.251|||TWO_SIDED|95.0|0.1|1.12|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 7||1.12|0.10|
70893216|NCT00833989|141273067|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.59|STANDARD_ERROR_OF_MEAN|0.242|||TWO_SIDED|95.0|0.09|1.08|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 7||1.08|0.09|
70893217|NCT00833989|141273067|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.277|||TWO_SIDED|95.0|-0.39|0.73|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 7||0.73|-0.39|
70893218|NCT00833989|141273068|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.56|STANDARD_ERROR_OF_MEAN|4.981|||TWO_SIDED|95.0|-0.6|19.71|||Mixed Model Repeated Measures Analysis||Mean difference =GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, visit 4||19.71|-0.60|
70893219|NCT00833989|141273068|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.47|STANDARD_ERROR_OF_MEAN|4.801|||TWO_SIDED|95.0|-1.32|18.26|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 4||18.26|-1.32|
70893220|NCT00833989|141273068|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|5.47|||TWO_SIDED|95.0|-11.1|11.24|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 4||11.24|-11.1|
70893221|NCT00833989|141273068|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.58|STANDARD_ERROR_OF_MEAN|5.631|||TWO_SIDED|95.0|0.01|23.15|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 5||23.15|0.01|
70893222|NCT00833989|141273068|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.77|STANDARD_ERROR_OF_MEAN|5.411|||TWO_SIDED|95.0|-2.35|19.89|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 5||19.89|-2.35|
70893223|NCT00833989|141273068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|6.195|||TWO_SIDED|95.0|-12.2|13.21|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 5||13.21|-12.2|
70893224|NCT00833989|141273068|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.66|STANDARD_ERROR_OF_MEAN|5.351|||TWO_SIDED|95.0|-1.34|20.66|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 6||20.66|-1.34|
70893225|NCT00833989|141273068|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.45|STANDARD_ERROR_OF_MEAN|5.198|||TWO_SIDED|95.0|-3.22|18.13|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 6||18.13|-3.22|
70893226|NCT00833989|141273068|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.63|STANDARD_ERROR_OF_MEAN|5.959|||TWO_SIDED|95.0|-22.9|1.6|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 6||1.60|-22.9|
70893227|NCT00833989|141273068|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.59|STANDARD_ERROR_OF_MEAN|6.134|||TWO_SIDED|95.0|-3.07|22.24|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, visit 7||22.24|-3.07|
70893228|NCT00833989|141273068|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.89|STANDARD_ERROR_OF_MEAN|5.948|||TWO_SIDED|95.0|-6.37|18.15|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 7||18.15|-6.37|
70893229|NCT00833989|141273068|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.11|STANDARD_ERROR_OF_MEAN|6.768|||TWO_SIDED|95.0|-17.1|10.84|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 7||10.84|-17.1|
70893230|NCT00833989|141273069|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.47|STANDARD_ERROR_OF_MEAN|7.047|||TWO_SIDED|95.0|-15.81|12.86|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo.~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment \* Visit + Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 4||12.86|-15.81|
70893231|NCT00833989|141273069|SUPERIORITY_OR_OTHER||Median Difference (Net)|9.86|STANDARD_ERROR_OF_MEAN|6.852|||TWO_SIDED|95.0|-4.08|23.8|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo.~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment \* Visit + Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 4||23.80|-4.08|
70893232|NCT00833989|141273069|SUPERIORITY_OR_OTHER||Median Difference (Net)|-5.4|STANDARD_ERROR_OF_MEAN|7.376|||TWO_SIDED|95.0|-20.41|9.6|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo.~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment \* Visit + Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 4||9.60|-20.41|
70893233|NCT00833989|141273069|SUPERIORITY_OR_OTHER||Median Difference (Net)|-2.4|STANDARD_ERROR_OF_MEAN|10.04|||TWO_SIDED|95.0|-22.87|18.07|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo.~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment \* Visit + Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 7||18.07|-22.87|
70893234|NCT00833989|141273069|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.03|STANDARD_ERROR_OF_MEAN|10.31|||TWO_SIDED|95.0|-15.95|26.0|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo.~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment \* Visit + Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 7||26.00|-15.95|
70893235|NCT00833989|141273069|SUPERIORITY_OR_OTHER||Median Difference (Net)|-10.07|STANDARD_ERROR_OF_MEAN|10.916|||TWO_SIDED|95.0|-32.29|12.15|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment \* Visit + Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 7||12.15|-32.29|
70963610|NCT04427501|141432106|SUPERIORITY||Hazard Ratio (HR)|1.355||||0.007|TWO_SIDED||||||Stratified Log-rank|||||||0.007
70963611|NCT04427501|141432106|SUPERIORITY||Hazard Ratio (HR)|1.237||||0.033|TWO_SIDED||||||Stratified Log-rank|||||||0.033
70893236|NCT00833989|141273070|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|5.147|||TWO_SIDED|95.0|-10.4|10.61|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 4||10.61|-10.4|
70893237|NCT00833989|141273070|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.75|STANDARD_ERROR_OF_MEAN|5.157|||TWO_SIDED|95.0|-7.75|13.26|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 4||13.26|-7.75|
70893238|NCT00833989|141273070|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.85|STANDARD_ERROR_OF_MEAN|5.409|||TWO_SIDED|95.0|-6.17|15.88|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 4||15.88|-6.17|
70893239|NCT00833989|141273070|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2|STANDARD_ERROR_OF_MEAN|6.504|||TWO_SIDED|95.0|-12.1|14.45|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 5||14.45|-12.1|
70893240|NCT00833989|141273070|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.05|STANDARD_ERROR_OF_MEAN|6.426|||TWO_SIDED|95.0|-11.0|15.12|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 5||15.12|-11.0|
70893241|NCT00833989|141273070|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.22|STANDARD_ERROR_OF_MEAN|6.82|||TWO_SIDED|95.0|-16.1|11.68|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 5||11.68|-16.1|
70893242|NCT00833989|141273070|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.63|STANDARD_ERROR_OF_MEAN|6.664|||TWO_SIDED|95.0|-12.9|14.18|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 6||14.18|-12.9|
70893243|NCT00833989|141273070|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.03|STANDARD_ERROR_OF_MEAN|6.595||||95.0|-12.4|14.43|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 6||14.43|-12.4|
70893244|NCT00833989|141273070|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.95|STANDARD_ERROR_OF_MEAN|7.02|||TWO_SIDED|95.0|-15.2|13.32|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 6||13.32|-15.2|
70893245|NCT00833989|141273070|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.25|STANDARD_ERROR_OF_MEAN|6.953|||TWO_SIDED|95.0|-11.9|16.4|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 7||16.40|-11.9|
70893246|NCT00833989|141273070|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.52|STANDARD_ERROR_OF_MEAN|6.909|||TWO_SIDED|95.0|-10.5|17.55|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 7||17.55|-10.5|
70893247|NCT00833989|141273070|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|7.328|||TWO_SIDED|95.0|-15.4|14.39|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 7||14.39|-15.4|
70893248|NCT00833989|141273071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.66|STANDARD_ERROR_OF_MEAN|3.42|||TWO_SIDED|95.0|-5.33|8.65|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 4||8.65|-5.33|
70893249|NCT00833989|141273071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|3.55|||TWO_SIDED|95.0|-7.56|6.96|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 4||6.96|-7.56|
70893250|NCT00833989|141273071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.56|STANDARD_ERROR_OF_MEAN|3.534|||TWO_SIDED|95.0|-2.67|11.78|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 4||11.78|-2.67|
70893251|NCT00833989|141273071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.05|STANDARD_ERROR_OF_MEAN|3.841|||TWO_SIDED|95.0|-5.78|9.89|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 5||9.89|-5.78|
70893252|NCT00833989|141273071|SUPERIORITY_OR_OTHER||Median Difference (Net)|-2.35|STANDARD_ERROR_OF_MEAN|3.958|||TWO_SIDED|95.0|-10.4|5.72|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 5||5.72|-10.4|
70893253|NCT00833989|141273071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.44|STANDARD_ERROR_OF_MEAN|3.978|||TWO_SIDED|95.0|-6.68|9.55|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 5||9.55|-6.68|
70893254|NCT00833989|141273071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.46|STANDARD_ERROR_OF_MEAN|4.109|||TWO_SIDED|95.0|-4.94|11.85|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 6||11.85|-4.94|
70963612|NCT04427501|141432106|SUPERIORITY||Hazard Ratio (HR)|1.521||||0.017|TWO_SIDED||||||Stratified Log-rank|||||||0.017
70893255|NCT00833989|141273071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.49|STANDARD_ERROR_OF_MEAN|4.235|||TWO_SIDED|95.0|-8.15|9.12|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 6||9.12|-8.15|
70893256|NCT00833989|141273071|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.77|STANDARD_ERROR_OF_MEAN|4.28|||TWO_SIDED|95.0|-7.97|9.5|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 6||9.50|-7.97|
70893257|NCT00833989|141273071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.04|STANDARD_ERROR_OF_MEAN|4.205|||TWO_SIDED|95.0|-5.53|11.61|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 7||11.61|-5.53|
70893258|NCT00833989|141273071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.58|STANDARD_ERROR_OF_MEAN|4.376|||TWO_SIDED|95.0|-11.5|6.32|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 7||6.32|-11.5|
70893259|NCT00833989|141273071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.73|STANDARD_ERROR_OF_MEAN|4.396|||TWO_SIDED|95.0|-5.22|12.69|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 7||12.69|-5.22|
70893260|NCT00833989|141273072|SUPERIORITY_OR_OTHER|||||||0.926|||||||Fisher Exact|||Visit 4||||0.9260
70893261|NCT00833989|141273072|SUPERIORITY_OR_OTHER|||||||0.5647|||||||Fisher Exact|||Visit 6||||0.5647
70893262|NCT00833989|141273073|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.34|STANDARD_ERROR_OF_MEAN|0.896|||TWO_SIDED|95.0|-3.17|0.49|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 3||0.49|-3.17|
70893263|NCT00833989|141273073|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.861|||TWO_SIDED|95.0|-1.95|1.57|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 3||1.57|-1.95|
70893264|NCT00833989|141273073|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.92|STANDARD_ERROR_OF_MEAN|0.933|||TWO_SIDED|95.0|-4.83|-1.02|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 3||-1.02|-4.83|
70893265|NCT00833989|141273073|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.868|||TWO_SIDED|95.0|-2.47|1.08|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 4||1.08|-2.47|
70893266|NCT00833989|141273073|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.834|||TWO_SIDED|95.0|-1.98|1.44|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 4||1.44|-1.98|
70893267|NCT00833989|141273073|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.92|STANDARD_ERROR_OF_MEAN|0.904|||TWO_SIDED|95.0|-2.77|0.92|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 4||0.92|-2.77|
70893268|NCT00833989|141273073|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.03|STANDARD_ERROR_OF_MEAN|1.278|||TWO_SIDED|95.0|-3.64|1.57|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 6||1.57|-3.64|
70893269|NCT00833989|141273073|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.37|STANDARD_ERROR_OF_MEAN|1.278|||TWO_SIDED|95.0|-2.97|2.24|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 6||2.24|-2.97|
70893270|NCT00833989|141273073|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.37|STANDARD_ERROR_OF_MEAN|2.21|||TWO_SIDED|95.0|-0.66|1.408|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 6||1.408|-0.66|
70893271|NCT00833989|141273074|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.46|STANDARD_ERROR_OF_MEAN|12.584|||TWO_SIDED|95.0|-6.11|45.04|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Barthel Total Score= Treatment + Visit + Treatment \*Visit|Placebo Vs GSK249320 1 mg/kg, Visit 4||45.04|-6.11|
70893272|NCT00833989|141273074|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.99|STANDARD_ERROR_OF_MEAN|12.131|||TWO_SIDED|95.0|-3.66|45.64|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Barthel Total Score= Treatment + Visit + Treatment \*Visit|Placebo Vs GSK249320 5 mg/kg, Visit 4||45.64|-3.66|
70893273|NCT00833989|141273074|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.79|STANDARD_ERROR_OF_MEAN|13.143|||TWO_SIDED|95.0|-14.9|38.5|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Barthel Total Score= Treatment + Visit + Treatment \*Visit|Placebo Vs GSK249320 15 mg/kg, Visit 4||38.50|-14.9|
70893274|NCT00833989|141273074|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.71|STANDARD_ERROR_OF_MEAN|9.021|||TWO_SIDED|95.0|-2.63|34.06|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Barthel Total Score= Treatment + Visit + Treatment \*Visit|Placebo Vs GSK249320 1 mg/kg, Visit 6||34.06|-2.63|
70893275|NCT00833989|141273074|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.56|STANDARD_ERROR_OF_MEAN|8.835|||TWO_SIDED|95.0|-6.38|29.5|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Barthel Total Score= Treatment + Visit + Treatment \*Visit|Placebo Vs GSK249320 5 mg/kg, Visit 6||29.50|-6.38|
70893276|NCT00833989|141273074|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.49|STANDARD_ERROR_OF_MEAN|9.641|||TWO_SIDED|95.0|-27.1|12.08|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Barthel Total Score= Treatment + Visit + Treatment \*Visit|Placebo Vs GSK249320 15 mg/kg, Visit 6||12.08|-27.1|
70963613|NCT04427501|141432107|SUPERIORITY||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.243||0.499|TWO_SIDED|95.0|-0.31|0.64|||Mixed Models Analysis|||||0.64|-0.31|0.499
70893277|NCT00833989|141273075|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|1.849|||TWO_SIDED|95.0|-4.12|3.43|||ANCOVA||Mean difference= GSK249320 1 mg/kg - Placebo Day 90 MoCA = Treatment + Day 5 MoCA|Placebo Vs GSK249320 1 mg/kg, Visit 6||3.43|-4.12|
70893278|NCT00833989|141273075|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|1.856|||TWO_SIDED|95.0|-3.96|3.62|||ANCOVA||Mean difference= GSK249320 5 mg/kg - Placebo Day 90 MoCA = Treatment + Day 5 MoCA|Placebo Vs GSK249320 5 mg/kg, Visit 6||3.62|-3.96|
70893279|NCT00833989|141273075|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.15|STANDARD_ERROR_OF_MEAN|2.037|||TWO_SIDED|95.0|-5.31|3.01|||ANCOVA||Mean difference= GSK249320 15 mg/kg - Placebo Day 90 MoCA = Treatment + Day 5 MoCA|Placebo Vs GSK249320 15 mg/kg, Visit 6||3.01|-5.31|
70893280|NCT00833989|141273076|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|1.408|||TWO_SIDED|95.0|-3.12|2.63|||ANCOVA||"Mean difference= GSK249320 1 mg/kg - Placebo.~Day 90 GDS Score= Treatment + Day 5 GDS Score"|Placebo Vs GSK249320 1 mg/kg, Visit 6||2.63|-3.12|
70893281|NCT00833989|141273076|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.55|STANDARD_ERROR_OF_MEAN|1.347|||TWO_SIDED|95.0|-1.2|4.3|||ANCOVA||"Mean difference= GSK249320 5 mg/kg - Placebo~Day 90 GDS Score= Treatment + Day 5 GDS Score"|Placebo Vs GSK249320 5 mg/kg, Visit 6||4.30|-1.20|
70893282|NCT00833989|141273076|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|1.486|||TWO_SIDED|95.0|-3.09|2.98|||ANCOVA||"Mean difference= GSK249320 15 mg/kg - Placebo.~Day 90 GDS Score= Treatment+Day 5 GDS Score"|Placebo Vs GSK249320 15 mg/kg, Visit 6||2.98|-3.09|
70893283|NCT00833989|141273077|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.289|STANDARD_ERROR_OF_MEAN|0.2639|||TWO_SIDED|95.0|-0.841|0.264|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline|Stimulation Level 100%, Visit 4 Day 30||0.264|-0.841|
70893284|NCT00833989|141273077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|0.2637|||TWO_SIDED|95.0|-0.862|0.241|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 100%, Visit 4 Day 30||0.241|-0.862|
70893285|NCT00833989|141273077|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.303|STANDARD_ERROR_OF_MEAN|0.3172|||TWO_SIDED|95.0|-0.966|0.361|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 100%, Visit 4 Day 30||0.361|-0.966|
70893286|NCT00833989|141273077|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.204|STANDARD_ERROR_OF_MEAN|0.1841|||TWO_SIDED|95.0|-0.184|0.593|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 100%, Visit 7 Day 112||0.593|-0.184|
70893287|NCT00833989|141273077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.105|STANDARD_ERROR_OF_MEAN|0.1846|||TWO_SIDED|95.0|-0.284|0.494|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 100%, Visit 7 Day 112||0.494|-0.284|
70893288|NCT00833989|141273077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.416|STANDARD_ERROR_OF_MEAN|0.2602|||TWO_SIDED|95.0|-0.132|0.965|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 100%, Visit 7 Day 112||0.965|-0.132|
70893289|NCT00833989|141273077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.156|STANDARD_ERROR_OF_MEAN|0.8652|||TWO_SIDED|95.0|-0.65|2.961|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 110%, Visit 4 Day 30||2.961|-0.650|
70893290|NCT00833989|141273077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.518|STANDARD_ERROR_OF_MEAN|0.8324|||TWO_SIDED|95.0|-2.249|1.213|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 110%, Visit 4 Day 30||1.213|-2.249|
70893291|NCT00833989|141273077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.269|STANDARD_ERROR_OF_MEAN|1.0383|||TWO_SIDED|95.0|-2.436|1.898|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 110%, Visit 4 Day 30||1.898|-2.436|
70893292|NCT00833989|141273077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.806|STANDARD_ERROR_OF_MEAN|0.5862|||TWO_SIDED|95.0|-0.42|2.031|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 110%, Visit 7 Day 112||2.031|-0.420|
70893293|NCT00833989|141273077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.007|STANDARD_ERROR_OF_MEAN|0.564|||TWO_SIDED|95.0|-1.183|1.168|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit"|Stimulation Level 110%, Visit 7 Day 112||1.168|-1.183|
70893294|NCT00833989|141273077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.506|STANDARD_ERROR_OF_MEAN|0.757|||TWO_SIDED|95.0|-0.064|3.077|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 110%, Visit 7 Day 112||3.077|-0.064|
70893295|NCT00833989|141273077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.644|STANDARD_ERROR_OF_MEAN|1.2976|||TWO_SIDED|95.0|-1.056|4.344|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 120%, Visit 4 Day 30||4.344|-1.056|
70893296|NCT00833989|141273077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.231|STANDARD_ERROR_OF_MEAN|1.1762|||TWO_SIDED|95.0|-2.681|2.219|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 120%, Visit 4 Day 30||2.219|-2.681|
70893297|NCT00833989|141273077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.184|STANDARD_ERROR_OF_MEAN|1.4796|||TWO_SIDED|95.0|-3.279|2.91|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 120%, Visit 4 Day 30||2.910|-3.279|
70893298|NCT00833989|141273077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.622|STANDARD_ERROR_OF_MEAN|0.9746|||TWO_SIDED|95.0|-1.428|2.672|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 120%, Visit 7 Day 112||2.672|-1.428|
70963614|NCT04427501|141432107|SUPERIORITY||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.241||0.492|TWO_SIDED|95.0|-0.64|0.31|||Mixed Models Analysis|||||0.31|-0.64|0.492
70893299|NCT00833989|141273077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.602|STANDARD_ERROR_OF_MEAN|0.934|||TWO_SIDED|95.0|-2.56|1.356|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 120%, Visit 7 Day 112||1.356|-2.560|
70893300|NCT00833989|141273077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.063|STANDARD_ERROR_OF_MEAN|1.281|||TWO_SIDED|95.0|-0.61|4.736|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 120%, Visit 7 Day 112||4.736|-0.610|
70893301|NCT00833989|141273077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.556|STANDARD_ERROR_OF_MEAN|1.4588|||TWO_SIDED|95.0|-1.494|4.607|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 130%, Visit 4 Day 30||4.607|-1.494|
70893302|NCT00833989|141273077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.531|STANDARD_ERROR_OF_MEAN|1.2336|||TWO_SIDED|95.0|-3.102|2.041|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 130%, Visit 4 Day 30||2.041|-3.102|
70893303|NCT00833989|141273077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.185|STANDARD_ERROR_OF_MEAN|1.5697|||TWO_SIDED|95.0|-3.471|3.101|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 130%, Visit 4 Day 30||3.101|-3.471|
70893304|NCT00833989|141273077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.686|STANDARD_ERROR_OF_MEAN|1.2689|||TWO_SIDED|95.0|-1.996|3.367|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 130%, Visit 7 Day 112||3.367|-1.996|
70893305|NCT00833989|141273077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.556|STANDARD_ERROR_OF_MEAN|1.0822|||TWO_SIDED|95.0|-2.838|1.726|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 130%, Visit 7 Day 112||1.726|-2.838|
70893306|NCT00833989|141273077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.219|STANDARD_ERROR_OF_MEAN|1.4792|||TWO_SIDED|95.0|-0.884|5.322|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 130%, Visit 7 Day 112||5.322|-0.884|
70893307|NCT00833989|141273077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.631|STANDARD_ERROR_OF_MEAN|1.589|||TWO_SIDED|95.0|-1.696|4.958|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 140%, Visit 4 Day 30||4.958|-1.696|
70893308|NCT00833989|141273077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.508|STANDARD_ERROR_OF_MEAN|1.2985|||TWO_SIDED|95.0|-3.219|2.203|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 140%, Visit 4 Day 30||2.203|-3.219|
70893309|NCT00833989|141273077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|1.6603|||TWO_SIDED|95.0|-3.369|3.588|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 140%, Visit 4 Day 30||3.588|-3.369|
70893310|NCT00833989|141273077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.852|STANDARD_ERROR_OF_MEAN|1.5675|||TWO_SIDED|95.0|-2.446|4.15|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 140%, Visit 7 Day 112||4.150|-2.446|
70893311|NCT00833989|141273077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.357|STANDARD_ERROR_OF_MEAN|1.2918|||TWO_SIDED|95.0|-3.074|2.359|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 140%, Visit 7 Day 112||2.359|-3.074|
70893312|NCT00833989|141273077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.686|STANDARD_ERROR_OF_MEAN|1.7306|||TWO_SIDED|95.0|-1.937|5.308|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 140%, Visit 7 Day 112||5.308|-1.937|
70893313|NCT02105948|141273087|SUPERIORITY||Rate ratio (mepolizumab/placebo)|0.82|||=|0.036|TWO_SIDED|95.0|0.68|0.98||Adjusted p-value to account for two treatment comparisons|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no.of moderate/severe exacerbations in previous year, Baseline percent predicted for FEV1,smoking status and offset of log (time in on-and off-treatment period)|||0.98|0.68|=0.036
70893314|NCT02105948|141273087|SUPERIORITY||Rate ratio (mepolizumab/placebo)|0.82|||=|0.029|TWO_SIDED|95.0|0.68|0.98||Unadjusted p-value.|Negative binomial mode||Analysis using a negative binomial model with covariates of treatment, geographic region, no.of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period)|||0.98|0.68|=0.029
70893315|NCT02105948|141273088|SUPERIORITY||Rate ratio (mepolizumab/placebo)|0.98|||>|0.999|TWO_SIDED|95.0|0.85|1.12||Adjusted p-value to account for two treatment comparisons|Negative Binomial Model||Analysis using a negative binomial model with covariates of treatment, geographic region, no.of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period)|||1.12|0.85|>0.999
70893316|NCT02105948|141273088|SUPERIORITY||Rate ratio (mepolizumab/placebo)|0.98|||=|0.731|TWO_SIDED|95.0|0.85|1.12||Unadjusted p-value.|Negative binomial mode||Analysis using a negative binomial model with covariates of treatment, geographic region, no.of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period)|||1.12|0.85|=0.731
70893317|NCT02105948|141273089|SUPERIORITY||Hazard ratio (Mepolizumab/placebo)|0.75|||=|0.036|TWO_SIDED|95.0|0.6|0.94||Adjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||0.94|0.60|=0.036
70893318|NCT02105948|141273089|SUPERIORITY||Hazard ratio (Mepolizumab/placebo)|0.75|||=|0.012|TWO_SIDED|95.0|0.6|0.94||Unadjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||0.94|0.60|=0.012
70893319|NCT02105948|141273090|SUPERIORITY||Rate ratio (mepolizumab/placebo)|1.16|||=|0.598|TWO_SIDED|95.0|0.77|1.75||Adjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period).|||1.75|0.77|=0.598
70893320|NCT02105948|141273090|SUPERIORITY||Rate ratio (mepolizumab/placebo)|1.16|||=|0.479|TWO_SIDED|95.0|0.77|1.75||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period).|||1.75|0.77|=0.479
70893321|NCT02105948|141273091|SUPERIORITY||Mean Difference (Mepolizumab - Placebo)|0.2|||>|0.999|TWO_SIDED|95.0|-2.8|3.2||Adjusted p-value|Mixed Model Repeated Measure Analysis||Analysis performed using mixed model repeated measures with covariates of baseline SGRQ Total Score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||3.2|-2.8|>0.999
70893322|NCT02105948|141273091|SUPERIORITY||Mean Difference (Mepolizumab - Placebo)|0.2|||=|0.901|TWO_SIDED|95.0|-2.8|3.2||Unadjusted p-value|Mixed Model Repeated Measure Analysis||Analysis performed using mixed model repeated measures with covariates of baseline SGRQ Total Score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||3.2|-2.8|=0.901
70893323|NCT02105948|141273092|SUPERIORITY||Mean Difference (Mepolizumab - Placebo)|-0.8|||>|0.999|TWO_SIDED|95.0|-2.0|0.5||Adjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.5|-2.0|>0.999
70893324|NCT02105948|141273092|SUPERIORITY||Mean Difference (Mepolizumab - Placebo)|-0.8|||=|0.244|TWO_SIDED|95.0|-2.0|0.5||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.5|-2.0|=0.244
70893325|NCT02105948|141273093|SUPERIORITY||Hazard ratio (Mepolizumab/Placebo)|0.89|||>|0.999|TWO_SIDED|95.0|0.75|1.05||Adjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||1.05|0.75|>0.999
70893326|NCT02105948|141273093|SUPERIORITY||Hazard ratio (Mepolizumab/Placebo)|0.89|||=|0.16|TWO_SIDED|95.0|0.75|1.05||Unadjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||1.05|0.75|=0.160
70893327|NCT02105948|141273094|SUPERIORITY||Rate ratio (mepolizumab/placebo)|1.1|||>|0.999|TWO_SIDED|95.0|0.81|1.49||Adjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period).|||1.49|0.81|>0.999
70893328|NCT02105948|141273094|SUPERIORITY||Rate ratio (mepolizumab/placebo)|1.1|||=|0.556|TWO_SIDED|95.0|0.81|1.49||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period).|||1.49|0.81|=0.556
70893329|NCT02105948|141273095|SUPERIORITY||Mean difference (Mepolizumab - Placebo)|0.7|||>|0.999|TWO_SIDED|95.0|-1.5|2.9||Adjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline SGRQ Total Score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||2.9|-1.5|>0.999
70893330|NCT02105948|141273095|SUPERIORITY||Mean difference (Mepolizumab - Placebo)|0.7|||=|0.532|TWO_SIDED|95.0|-1.5|2.9||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline SGRQ Total Score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||2.9|-1.5|=0.532
70893331|NCT02105948|141273096|SUPERIORITY||Mean difference (Mepolizumab - Placebo)|-0.6|||>|0.999|TWO_SIDED|95.0|-1.5|0.4||Adjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.4|-1.5|>0.999
70893332|NCT02105948|141273096|SUPERIORITY||Mean difference (Mepolizumab - Placebo)|-0.6|||=|0.252|TWO_SIDED|95.0|-1.5|0.4||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.4|-1.5|=0.252
70893333|NCT01587651|141273101|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was assessed using a 95% CI of the difference in mean PRU between ticagrelor and prasugrel (2 arms combined). Under the assumption of 0 difference in mean PRU between prasugrel 10 mg QD MD and ticagrelor 90 mg BID MD, a common SD of 60 PRU (based on previous DSI studies and published data), and a drop-out rate not exceeding 15%, a sample size of 105 allows for the 95% CI to stay within ± 45 PRU (non-inferiority margin) with a power of 90%.|Mean Difference (Final Values)|46.0|STANDARD_ERROR_OF_MEAN|10.66|||TWO_SIDED|95.0|24.9|67.2||||||ANCOVA model included treatment as a main effect and pre-randomization baseline PRU as a covariate. The combined prasugrel groups were modeled as a single treatment. If the upper limit of the CI for the mean difference was not greater than 45 PRU, then the PD response to prasugrel 10 mg QD MD was deemed noninferior to that achieved by ticagrelor 90 mg BID MD.||67.2|24.9|
70893334|NCT01660763|141273161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|87.59|STANDARD_ERROR_OF_MEAN|10.88|<|0.001|TWO_SIDED|95.0|66.2|108.98|||ANCOVA|||||108.98|66.20|<0.001
70963615|NCT04427501|141432107|SUPERIORITY||Mean Difference (Net)|0.38|STANDARD_ERROR_OF_MEAN|0.246||0.125|TWO_SIDED|95.0|-0.11|0.86|||Mixed Models Analysis|||||0.86|-0.11|0.125
70963616|NCT04427501|141432107|SUPERIORITY||Mean Difference (Net)|-0.43|STANDARD_ERROR_OF_MEAN|0.236||0.069|TWO_SIDED|95.0|-0.89|0.03|||Mixed Models Analysis|||||0.03|-0.89|0.069
70893335|NCT03325712|141273163|OTHER||Slope|0.8188|STANDARD_ERROR_OF_MEAN|0.0725|||TWO_SIDED|90.0|0.6966|0.941|||||Based on the estimate for slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is standard error of slope.|The basic model for the investigation of dose proportionality is a power model that describes the functional relationship between the dose and PK endpoints. Statistical hypotheses were not tested in a confirmatory sense.||0.9410|0.6966|
70893336|NCT03325712|141273164|OTHER||Slope|0.7708|STANDARD_ERROR_OF_MEAN|0.0747|||TWO_SIDED|90.0|0.6449|0.8967|||||Based on the estimate for slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is standard error of slope.|The basic model for the investigation of dose proportionality is a power model that describes the functional relationship between the dose and PK endpoints. Statistical hypotheses were not tested in a confirmatory sense.||0.8967|0.6449|
70893337|NCT03325712|141273165|OTHER||Slope|0.7167|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|90.0|0.4922|0.9412|||||Based on the estimate for slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is standard error of slope.|The basic model for the investigation of dose proportionality is a power model that describes the functional relationship between the dose and PK endpoints. Statistical hypotheses were not tested in a confirmatory sense.||0.9412|0.4922|
70893338|NCT03325712|141273166|OTHER||Slope|0.6825|STANDARD_ERROR_OF_MEAN|0.1344|||TWO_SIDED|90.0|0.4556|0.9094|||||Based on the estimate for slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is standard error of slope.|The basic model for the investigation of dose proportionality is a power model that describes the functional relationship between the dose and PK endpoints. Statistical hypotheses were not tested in a confirmatory sense.||0.9094|0.4556|
70893339|NCT03325712|141273167|OTHER||Ratio (T/R)|102.81|STANDARD_DEVIATION|17.5|||TWO_SIDED|90.0|87.18|121.25||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"Placebo matching BI 705564. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||121.25|87.18|
70893340|NCT03325712|141273167|OTHER||Ratio (T/R)|93.06|STANDARD_DEVIATION|17.4|||TWO_SIDED|90.0|79.94|108.32||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 2. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||108.32|79.94|
70893341|NCT03325712|141273167|OTHER||Ratio (T/R)|109.82|STANDARD_DEVIATION|5.0|||TWO_SIDED|90.0|103.59|116.42||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 3. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||116.42|103.59|
70893342|NCT03325712|141273167|OTHER||Ratio ( T/R)|108.37|STANDARD_DEVIATION|17.4|||TWO_SIDED|90.0|92.0|127.66||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 5. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||127.66|92.00|
70893343|NCT03325712|141273167|OTHER||Ratio (T/R)|109.11|STANDARD_DEVIATION|17.6|||TWO_SIDED|90.0|92.43|128.79||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 4. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||128.79|92.43|
70893344|NCT03325712|141273168|OTHER||Ratio (T/R)|100.1|STANDARD_DEVIATION|18.7|||TWO_SIDED|90.0|83.99|119.31||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"Placebo matching BI 705564. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||119.31|83.99|
70893345|NCT03325712|141273168|OTHER||Ratio (T/R)|84.43|STANDARD_DEVIATION|16.5|||TWO_SIDED|90.0|72.29|98.62||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 2. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||98.62|72.29|
70893346|NCT03325712|141273168|OTHER||Ratio (T/R)|109.41|STANDARD_DEVIATION|13.1|||TWO_SIDED|90.0|94.34|126.88||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 3. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||126.88|94.34|
70893347|NCT03325712|141273168|OTHER||Ratio (T/R)|95.44|STANDARD_DEVIATION|19.1|||TWO_SIDED|90.0|79.75|114.21||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 5. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||114.21|79.75|
70893348|NCT03325712|141273168|OTHER||Ratio (T/R)|90.04|STANDARD_DEVIATION|25.9|||TWO_SIDED|90.0|70.75|114.59||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 4. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||114.59|70.75|
70893349|NCT00952653|141273169|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|71.4|||||TWO_SIDED|90.0|65.08|78.33|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference). Based on the sample size, this study has at least 85% power overall to demonstrate the lack of an interaction \[that is, equivalence in both AUCinf and Cmax and both midazolam and 1-hydroxy midazolam\], where overall study power is to be based on the product of the individual powers of the parameters of interest.||78.33|65.08|
70893350|NCT00952653|141273170|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|86.08|||||TWO_SIDED|90.0|79.04|93.74|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference). Based on the sample size, this study has at least 85% power overall to demonstrate the lack of an interaction \[that is, equivalence in both AUCinf and Cmax and both midazolam and 1-hydroxy midazolam\], where overall study power is to be based on the product of the individual powers of the parameters of interest.||93.74|79.04|
70893351|NCT00952653|141273171|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|92.55|||||TWO_SIDED|90.0|87.43|97.97|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference). Based on the sample size, this study has at least 85% power overall to demonstrate the lack of an interaction \[that is, equivalence in both AUCinf and Cmax and both midazolam and 1-hydroxy midazolam\], where overall study power is to be based on the product of the individual powers of the parameters of interest.||97.97|87.43|
70893352|NCT00952653|141273172|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|101.17|||||TWO_SIDED|90.0|92.96|110.11|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference). Based on the sample size, this study has at least 85% power overall to demonstrate the lack of an interaction \[that is, equivalence in both AUCinf and Cmax and both midazolam and 1-hydroxy midazolam\], where overall study power is to be based on the product of the individual powers of the parameters of interest.||110.11|92.96|
70893353|NCT00952653|141273173|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|72.1|||||TWO_SIDED|90.0|66.04|78.72|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference)||78.72|66.04|
70893354|NCT00952653|141273176|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|87.39|||||TWO_SIDED|90.0|80.42|94.96|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference)||94.96|80.42|
70893355|NCT02265237|141273179|SUPERIORITY|97.5% CI was calculated using the Wilson score method; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 67% to achieve superiority. The predefined threshold of 67% was based on historical SVR rates for HCV genotype 4 (GT4)-infected subjects treated with pegIFN/RBV.|Percentage of Participants|100.0|||||TWO_SIDED|97.5|92.4|100.0|||||The confidence interval was calculated using the Wilson score method.|The overall 2-sided significance level of 0.05 was split between Part I (arms A and B) and Part II (arm C) using a Bonferroni corrected alpha level of 0.025 for each part. Additionally, a fixed sequence procedure for Part I was used to proceed through the primary efficacy comparisons in the following order: 1) test of superiority of arm B and 2) test of superiority of arm A. The primary outcome within Arm C was tested with a Bonferroni-corrected Type 1 error rate of 0.025 for superiority.||100.0|92.4|
70893356|NCT02265237|141273179|SUPERIORITY|97.5% confidence interval (CI) was calculated using the Wilson score method; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 67% to achieve superiority. The predefined threshold of 67% was based on historical SVR rates for HCV GT4-infected subjects treated with pegIFN/RBV.|Percentage of Participants|96.6|||||TWO_SIDED|97.5|86.7|99.2|||||The confidence interval was calculated using the Wilson score method.|The overall 2-sided significance level of 0.05 was split between Part I (arms A and B) and Part II (arm C) using a Bonferroni corrected alpha level of 0.025 for each part. Additionally, a fixed sequence procedure for Part I was used to proceed through the primary efficacy comparisons in the following order: 1) test of superiority of arm B and 2) test of superiority of arm A. The primary outcome within Arm C was tested with a Bonferroni-corrected Type 1 error rate of 0.025 for superiority.||99.2|86.7|
70893357|NCT02265237|141273179|SUPERIORITY|97.5% CI was calculated using the Wilson score method; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 67% to achieve superiority. The predefined threshold of 67% was based on historical SVR rates for HCV genotype 4 (GT4)-infected subjects treated with pegIFN/RBV.|Percentage of Participants|93.4|||||TWO_SIDED|97.5|82.6|97.7|||||The confidence interval was calculated using the Wilson score method.|The overall 2-sided significance level of 0.05 was split between Part I (arms A and B) and Part II (arm C) using a Bonferroni corrected alpha level of 0.025 for each part. Additionally, a fixed sequence procedure for Part I was used to proceed through the primary efficacy comparisons in the following order: 1) test of superiority of arm B and 2) test of superiority of arm A. The primary outcome within Arm C was tested with a Bonferroni-corrected Type 1 error rate of 0.025 for superiority.||97.7|82.6|
70893358|NCT02265237|141273180|SUPERIORITY|Treatment differences (with 95% confidence intervals) and corresponding P-value for the specified comparisons were estimated using stratum adjusted Mantel-Haenszel (MH) proportion and continuity-corrected variance, adjusting for IFN/RBV treatment history (treatment-naïve or treatment-experienced).|Stratum-Adjusted MH Difference|-3.39||||0.304|TWO_SIDED|95.0|-9.85|3.07|||Mantel Haenszel|||Within Part I (arm A and B), since superiority was demonstrated for both arms in the primary outcome measures, testing continued to the first secondary outcome measure.||3.07|-9.85|0.304
70893359|NCT02265237|141273181|SUPERIORITY|Treatment differences (with 95% confidence intervals) and corresponding P-value for the specified comparisons were estimated using stratum adjusted Mantel-Haenszel proportion and continuity-corrected variance, adjusting for IFN/RBV treatment history (treatment-naïve or treatment-experienced).|Stratum-Adjusted MH Difference|6.45||||0.086|TWO_SIDED|95.0|-0.91|13.81|||Mantel Haenszel|||Within Part II (arm C), since superiority was demonstrated for the primary outcome measure, testing continued to the second secondary outcome measure.||13.81|-0.91|0.086
70893360|NCT00839072|141273205|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LS means) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax does not exceed 125%.|Ratio of the mean|59.66|||||TWO_SIDED|90.0|50.99|69.81|||||Trazodone Contramid® OAD/Desyrel®|||69.81|50.99|
70893361|NCT00839072|141273206|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUCT is between 80% and 125%.|Ratio of the mean|78.55|||||TWO_SIDED|90.0|69.7|88.51|||||Trazodone Contramid® OAD/Desyrel®|||88.51|69.70|
70893362|NCT00839072|141273207|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC∞ is between 80% and 125%.|Ratio of the mean|80.05|||||TWO_SIDED|90.0|70.67|90.68|||||Trazodone Contramid® OAD/Desyrel®|||90.68|70.67|
70893363|NCT05003791|141273211|OTHER|This was a cross-sectional design|||||<|0.05|||||||Regression, Linear|||||||<0.05
70893364|NCT05003791|141273212|OTHER|This was a cross-sectional design|||||<|0.05|||||||Regression, Linear|||||||<0.05
70893365|NCT05003791|141273213|OTHER|This was a cross-sectional design|||||<|0.05|||||||Regression, Linear|||||||<0.05
70893366|NCT00380068|141273214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.5|STANDARD_DEVIATION|65.64|<|0.001||95.0|11.8|29.3|||t-test, 2 sided|Paired t-test on change from Baseline to Week 24||||29.3|11.8|<0.001
70893367|NCT00380068|141273215|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|2.11|<|0.001||95.0|-0.8|-0.3|||t-test, 2 sided|Paired t-test on change from Baseline to Week 24||||-0.3|-0.8|<0.001
70893368|NCT00380068|141273216|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.001||95.0|-1.0|-0.2|||t-test, 2 sided|Paired t-test on change from Baseline to Week 48||||-0.2|-1.0|0.001
70893369|NCT00380068|141273217|SUPERIORITY_OR_OTHER||Percent change from baseline|-25.5||||||95.0|-33.6|-16.3|||||Percent change from baseline derived from Geometric Mean Ratio|||-16.3|-33.6|
70893370|NCT00380068|141273218|SUPERIORITY_OR_OTHER||Percent change from baseline|-29.2||||||95.0|-39.8|-16.6|||||Percent change from baseline derived from Geometric Mean Ratio|||-16.6|-39.8|
70893371|NCT00380068|141273219|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical test performed on actual change from baseline WHO functional Class (eg, a change from WHO Class III to II is -1; a change from WHO Class IV to II is -2; etc).|Wilcoxon signed-rank test|||||||<0.001
70893372|NCT00380068|141273220|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical test performed on actual change from baseline WHO functional Class (eg, a change from WHO Class III to II is -1; a change from WHO Class IV to II is -2; etc).|Wilcoxon signed-rank test|||||||<0.001
70893373|NCT00380068|141273221|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|Paired t-test on change from Baseline to Week 24||||||<0.001
70893374|NCT00380068|141273222|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|Paired t-test on change from Baseline to Week 48||||||<0.001
70893375|NCT00380068|141273223|SUPERIORITY_OR_OTHER||percent event free|89.4||||||95.0|84.4|92.8|||||Estimate obtained through Kaplan-Meier methods|||92.8|84.4|
70893376|NCT00380068|141273224|SUPERIORITY_OR_OTHER||percent event free|84.1||||||95.0|78.2|88.6|||||Estimate obtained through Kaplan-Meier methods|||88.6|78.2|
70893377|NCT00380068|141273225|SUPERIORITY_OR_OTHER||percent event free|95.3||||||95.0|91.4|97.4|||||Estimate obtained through Kaplan-Meier methods|||97.4|91.4|
70893378|NCT00380068|141273226|SUPERIORITY_OR_OTHER||percent event free|92.9||||||95.0|88.3|95.8|||||Estimate obtained through Kaplan-Meier methods|||95.8|88.3|
70893379|NCT00380068|141273227|SUPERIORITY_OR_OTHER||percent event free|95.0||||||95.0|88.5|97.9|||||Estimate obtained through Kaplan-Meier methods|||97.9|88.5|
70893380|NCT00380068|141273228|SUPERIORITY_OR_OTHER||percent event free|90.0||||||95.0|81.6|94.7|||||Estimate obtained through Kaplan-Meier methods|||94.7|81.6|
70893381|NCT00380068|141273229|SUPERIORITY_OR_OTHER||percent event free|97.1||||||95.0|93.6|98.7|||||Estimate obtained through Kaplan-Meier methods|||98.7|93.6|
70893382|NCT00380068|141273230|SUPERIORITY_OR_OTHER||percent event free|95.3||||||95.0|91.2|97.6|||||Estimate obtained through Kaplan-Meier methods|||97.6|91.2|
70893383|NCT01297062|141273231|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is established if the upper limit of 2-sided 90% confidence interval (CI), equivalent to the upper limit of 1-sided 95% CI, for change from baseline in QTcP (exenatide - placebo) is below 10 msec.|Least Squares Mean Difference|-1.36|||||TWO_SIDED|90.0|-2.21|-0.5||No adjustment on CI for the primary outcome measure.|Mixed Models Analysis||The MMRM includes Treatment (Exenatide versus Placebo), Day, Time, Period, Sequence, and Day-Time-Treatment interaction as fixed effects, subject random intercept.|60 evaluable subjects gives more than 90% power to show non-inferiority of exenatide versus placebo, using t-test in 2-way crossover, alpha=0.05, true difference of 5 msec, and standard deviation of the within-subject difference of 10.04 msec.||-0.50|-2.21|
70893384|NCT01297062|141273232|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is established if the upper limit of 2-sided 90% CI, equivalent to the upper limit of 1-sided 95% CI, for change from baseline in QTcP (exenatide - placebo) is below 10 msec.|Least Squares Mean Difference|-2.02|||||TWO_SIDED|90.0|-2.88|-1.16||No adjustment on CI for the primary outcome measure.|Mixed Models Analysis||The MMRM includes Treatment (Exenatide versus Placebo), Day, Time, Period, Sequence, and Day-Time-Treatment interaction as fixed effects, subject random intercept.|60 evaluable subjects gives more than 90% power to show non-inferiority of exenatide versus placebo, using t-test in 2-way crossover, alpha=0.05, true difference of 5 msec, and standard deviation of the within-subject difference of 10.04 msec.||-1.16|-2.88|
70893385|NCT01297062|141273233|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is established if the upper limit of 2-sided 90% CI, equivalent to the upper limit of 1-sided 95% CI, for change from baseline in QTcP (exenatide - placebo) is below 10 msec.|Least Squares Mean Difference|-1.13|||||TWO_SIDED|90.0|-2.11|-0.15||No adjustment on CI for the primary outcome measure.|Mixed Models Analysis||The MMRM includes Treatment (Exenatide versus Placebo), Day, Time, Period, Sequence, and Day-Time-Treatment interaction as fixed effects, subject random intercept.|60 evaluable subjects gives more than 90% power to show non-inferiority of exenatide versus placebo, using t-test in 2-way crossover, alpha=0.05, true difference of 5 msec, and standard deviation of the within-subject difference of 10.04 msec.||-0.15|-2.11|
70963617|NCT04427501|141432108|SUPERIORITY||Odds Ratio (OR)|1.74||||0.034|TWO_SIDED|95.0|1.04|2.9|||Regression, Logistic|||||2.90|1.04|0.034
70893386|NCT01297062|141273234|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.47|||||TWO_SIDED|90.0|2.82|8.12|||Mixed Models Analysis||The MMRM includes Treatment (Moxifloxacin versus Placebo), Time, Period, Sequence, and Time-Treatment interaction as fixed effects, subject random intercept. Multiplicity adjusted CI for the mean difference is shown.|Assay sensitivity of moxifloxacin is established if the lower limit of the 2-sided 90% CI for difference in change from baseline in QTcP (moxifloxacin - placebo) is greater than 5 msec.||8.12|2.82|
70893387|NCT01297062|141273235|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|10.56|||||TWO_SIDED|90.0|8.46|12.67|||Mixed Models Analysis||The MMRM includes Treatment (Moxifloxacin versus Placebo), Time, Period, Sequence, and Time-Treatment interaction as fixed effects, subject random intercept. Multiplicity adjusted CI for the mean difference is shown.|Assay sensitivity of moxifloxacin is established if the lower limit of the 2-sided 90% CI for difference in change from baseline in QTcP (moxifloxacin - placebo) is greater than 5 msec.||12.67|8.46|
70893388|NCT01297062|141273236|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|10.92|||||TWO_SIDED|90.0|8.71|13.13|||Mixed Models Analysis||The MMRM includes Treatment (Moxifloxacin versus Placebo), Time, Period, Sequence, and Time-Treatment interaction as fixed effects, subject random intercept. Multiplicity adjusted CI for the mean difference is shown.|Assay sensitivity of moxifloxacin is established if the lower limit of the 2-sided 90% CI for difference in change from baseline in QTcP (moxifloxacin - placebo) is greater than 5 msec.||13.13|8.71|
70893389|NCT01297062|141273239|SUPERIORITY_OR_OTHER||Slope|0.0008||||0.5962|TWO_SIDED|90.0|-0.0017|0.0033|||Mixed Models Analysis||The linear mixed-effects model includes placebo-adjusted change from baseline in QTcP as response, plasma exenatide concentration as covariate, fixed intercept of zero, subject random slope.|The analysis is to test the significance of the linear regression slope (null hypothesis: slope equal to zero) between placebo-adjusted change from baseline in QTcP and exenatide concentration.||0.0033|-0.0017|0.5962
70893390|NCT01458574|141273240|SUPERIORITY_OR_OTHER||Difference in percentage|23.2|||<|0.0001|TWO_SIDED|95.0|15.3|31.2|||CMH chi-square test|||P-value based on Cochran-Mantel-Haenszel (CMH) chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95 percent (%) confidence interval (CI) based on normal approximation for the difference in binomial proportions. Missing data were imputed using Non-responder imputation (NRI).||31.2|15.3|<0.0001
70893391|NCT01458574|141273240|SUPERIORITY_OR_OTHER||Difference in percentage|29.5|||<|0.0001|TWO_SIDED|95.0|21.4|37.6|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||37.6|21.4|<0.0001
70893392|NCT01458574|141273241|SUPERIORITY_OR_OTHER||Difference in percentage|24.2|||<|0.0001|TWO_SIDED|95.0|16.0|32.5|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||32.5|16.0|<0.0001
70893393|NCT01458574|141273241|SUPERIORITY_OR_OTHER||Difference in percentage|32.6|||<|0.0001|TWO_SIDED|95.0|24.2|41.0|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||41.0|24.2|<0.0001
70893394|NCT01458574|141273242|SUPERIORITY_OR_OTHER||Difference in percentage|30.3|||<|0.0001|TWO_SIDED|95.0|17.4|43.2|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||43.2|17.4|<0.0001
70893395|NCT01458574|141273242|SUPERIORITY_OR_OTHER||Difference in percentage|42.2|||<|0.0001|TWO_SIDED|95.0|27.9|56.5|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||56.5|27.9|<0.0001
70893396|NCT01458574|141273243|SUPERIORITY_OR_OTHER||Difference in percentage|22.7|||<|0.0001|TWO_SIDED|95.0|14.8|30.6|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||30.6|14.8|<0.0001
70893397|NCT01458574|141273243|SUPERIORITY_OR_OTHER||Difference in percentage|24.4|||<|0.0001|TWO_SIDED|95.0|16.4|32.4|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||32.4|16.4|<0.0001
70893398|NCT01458574|141273244|SUPERIORITY_OR_OTHER||Difference in percentage|17.2|||<|0.0001|TWO_SIDED|95.0|10.6|23.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||23.7|10.6|<0.0001
70893399|NCT01458574|141273244|SUPERIORITY_OR_OTHER||Difference in percentage|20.3|||<|0.0001|TWO_SIDED|95.0|13.5|27.1|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||27.1|13.5|<0.0001
70893400|NCT01458574|141273245|SUPERIORITY_OR_OTHER||Difference in percentage|26.8|||<|0.0001|TWO_SIDED|95.0|18.1|35.5|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||35.5|18.1|<0.0001
70893401|NCT01458574|141273245|SUPERIORITY_OR_OTHER||Difference in percentage|29.0|||<|0.0001|TWO_SIDED|95.0|20.3|37.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||37.7|20.3|<0.0001
70893402|NCT01458574|141273246|SUPERIORITY_OR_OTHER||Difference in percentage|21.2|||<|0.0001|TWO_SIDED|95.0|14.1|28.3|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||28.3|14.1|<0.0001
70893403|NCT01458574|141273246|SUPERIORITY_OR_OTHER||Difference in percentage|26.4|||<|0.0001|TWO_SIDED|95.0|19.0|33.8|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||33.8|19.0|<0.0001
70893404|NCT01458574|141273247|SUPERIORITY_OR_OTHER||Difference in percentage|30.6|||<|0.0001|TWO_SIDED|95.0|18.1|43.1|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||43.1|18.1|<0.0001
70893405|NCT01458574|141273247|SUPERIORITY_OR_OTHER||Difference in percentage|44.5|||<|0.0001|TWO_SIDED|95.0|31.8|57.2|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||57.2|31.8|<0.0001
70893406|NCT01458574|141273247|SUPERIORITY_OR_OTHER||Difference in percentage|30.0|||<|0.0001|TWO_SIDED|95.0|18.7|41.4|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||41.4|18.7|<0.0001
70893407|NCT01458574|141273247|SUPERIORITY_OR_OTHER||Difference in percentage|43.2|||<|0.0001|TWO_SIDED|95.0|31.1|55.3|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||55.3|31.1|<0.0001
70893408|NCT01458574|141273248|SUPERIORITY_OR_OTHER||Difference in percentage|24.4|||<|0.0001|TWO_SIDED|95.0|13.8|35.0|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||35.0|13.8|<0.0001
70893409|NCT01458574|141273248|SUPERIORITY_OR_OTHER||Difference in percentage|40.5|||<|0.0001|TWO_SIDED|95.0|28.7|52.3|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||52.3|28.7|<0.0001
70893410|NCT01458574|141273249|SUPERIORITY_OR_OTHER||Difference in percentage|30.3|||<|0.0001|TWO_SIDED|95.0|20.9|39.7|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||39.7|20.9|<0.0001
70893411|NCT01458574|141273249|SUPERIORITY_OR_OTHER||Difference in percentage|37.2|||<|0.0001|TWO_SIDED|95.0|28.1|46.4|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||46.4|28.1|<0.0001
70893412|NCT01458574|141273249|SUPERIORITY_OR_OTHER||Difference in percentage|31.3|||<|0.0001|TWO_SIDED|95.0|22.4|40.2|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||40.2|22.4|<0.0001
70893413|NCT01458574|141273249|SUPERIORITY_OR_OTHER||Difference in percentage|41.7|||<|0.0001|TWO_SIDED|95.0|32.9|50.5|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||50.5|32.9|<0.0001
70893414|NCT01458574|141273250|SUPERIORITY_OR_OTHER||Difference in percentage|29.8|||<|0.0001|TWO_SIDED|95.0|20.9|38.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||38.7|20.9|<0.0001
70893415|NCT01458574|141273250|SUPERIORITY_OR_OTHER||Difference in percentage|40.2|||<|0.0001|TWO_SIDED|95.0|31.4|49.0|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||49.0|31.4|<0.0001
70893416|NCT01458574|141273251|SUPERIORITY_OR_OTHER||Difference in percentage|23.2|||<|0.0001|TWO_SIDED|95.0|15.3|31.2|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||31.2|15.3|<0.0001
70893417|NCT01458574|141273251|SUPERIORITY_OR_OTHER||Difference in percentage|24.4|||<|0.0001|TWO_SIDED|95.0|16.4|32.4|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||32.4|16.4|<0.0001
70893418|NCT01458574|141273251|SUPERIORITY_OR_OTHER||Difference in percentage|23.2|||<|0.0001|TWO_SIDED|95.0|15.3|31.2|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||31.2|15.3|<0.0001
70893419|NCT01458574|141273251|SUPERIORITY_OR_OTHER||Difference in percentage|30.0|||<|0.0001|TWO_SIDED|95.0|21.9|38.2|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||38.2|21.9|<0.0001
70893420|NCT01458574|141273252|SUPERIORITY_OR_OTHER||Difference in percentage|17.2|||<|0.0001|TWO_SIDED|95.0|10.6|23.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||23.7|10.6|<0.0001
70963618|NCT04427501|141432108|SUPERIORITY||Odds Ratio (OR)|1.15||||0.594|TWO_SIDED|95.0|0.69|1.91|||Regression, Logistic|||||1.91|0.69|0.594
70893421|NCT01458574|141273252|SUPERIORITY_OR_OTHER||Difference in percentage|20.8|||<|0.0001|TWO_SIDED|95.0|14.0|27.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||27.7|14.0|<0.0001
70893422|NCT01458574|141273253|SUPERIORITY_OR_OTHER||Difference in percentage|10.1||||0.0006|TWO_SIDED|95.0|4.5|15.7|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||15.7|4.5|0.0006
70893423|NCT01458574|141273253|SUPERIORITY_OR_OTHER||Difference in percentage|6.6||||0.0092|TWO_SIDED|95.0|1.5|11.7|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||11.7|1.5|0.0092
70893424|NCT01458574|141273253|SUPERIORITY_OR_OTHER||Difference in percentage|10.6||||0.0004|TWO_SIDED|95.0|5.0|16.2|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||16.2|5.0|0.0004
70893425|NCT01458574|141273253|SUPERIORITY_OR_OTHER||Difference in percentage|11.2|||<|0.0001|TWO_SIDED|95.0|5.5|16.9|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||16.9|5.5|<0.0001
70893426|NCT01458574|141273254|SUPERIORITY_OR_OTHER||Difference in percentage|5.6||||0.0029|TWO_SIDED|95.0|2.1|9.0|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||9.0|2.1|0.0029
70893427|NCT01458574|141273254|SUPERIORITY_OR_OTHER||Difference in percentage|3.0||||0.035|TWO_SIDED|95.0|0.3|5.8|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||5.8|0.3|0.0350
70893428|NCT01458574|141273255|SUPERIORITY_OR_OTHER||Difference in percentage|17.2|||<|0.0001|TWO_SIDED|95.0|10.3|24.0|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||24.0|10.3|<0.0001
70893429|NCT01458574|141273255|SUPERIORITY_OR_OTHER||Difference in percentage|15.3|||<|0.0001|TWO_SIDED|95.0|8.5|22.0|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||22.0|8.5|<0.0001
70893430|NCT01458574|141273255|SUPERIORITY_OR_OTHER||Difference in percentage|15.7|||<|0.0001|TWO_SIDED|95.0|8.8|22.5|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||22.5|8.8|<0.0001
70893431|NCT01458574|141273255|SUPERIORITY_OR_OTHER||Difference in percentage|19.8|||<|0.0001|TWO_SIDED|95.0|12.7|27.0|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||27.0|12.7|<0.0001
70893432|NCT01458574|141273256|SUPERIORITY_OR_OTHER||Difference in percentage|11.1|||<|0.0001|TWO_SIDED|95.0|5.9|16.4|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||16.4|5.9|<0.0001
70893433|NCT01458574|141273256|SUPERIORITY_OR_OTHER||Difference in percentage|13.2|||<|0.0001|TWO_SIDED|95.0|7.7|18.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||18.7|7.7|<0.0001
70893434|NCT01458574|141273257|SUPERIORITY_OR_OTHER||Difference in percentage|12.1|||<|0.0001|TWO_SIDED|95.0|6.3|17.9|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||17.9|6.3|<0.0001
70893435|NCT01458574|141273257|SUPERIORITY_OR_OTHER||Difference in percentage|8.1||||0.0021|TWO_SIDED|95.0|2.8|13.5|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||13.5|2.8|0.0021
70893436|NCT01458574|141273257|SUPERIORITY_OR_OTHER||Difference in percentage|10.6||||0.0004|TWO_SIDED|95.0|5.0|16.2|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||16.2|5.0|0.0004
70893437|NCT01458574|141273257|SUPERIORITY_OR_OTHER||Difference in percentage|12.7|||<|0.0001|TWO_SIDED|95.0|6.8|18.6|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||18.6|6.8|<0.0001
70893438|NCT01458574|141273258|SUPERIORITY_OR_OTHER||Difference in percentage|5.6||||0.0029|TWO_SIDED|95.0|2.1|9.0|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||9.0|2.1|0.0029
70893439|NCT01458574|141273258|SUPERIORITY_OR_OTHER||Difference in percentage|4.6||||0.0064|TWO_SIDED|95.0|1.4|7.8|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||7.8|1.4|0.0064
70893440|NCT01458574|141273260|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.9|||Linear mixed effect model|||At Week 24||-1.9|-3.2|<0.0001
70893441|NCT01458574|141273260|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.8|||<|0.0001|TWO_SIDED|95.0|-3.5|-2.2|||Linear mixed effect model|||At Week 24||-2.2|-3.5|<0.0001
70893442|NCT01458574|141273260|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.4|-1.7|||Linear mixed effect model|||At Week 52||-1.7|-3.4|<0.0001
70893443|NCT01458574|141273260|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.3|||<|0.0001|TWO_SIDED|95.0|-4.1|-2.5|||Linear mixed effect model|||At Week 52||-2.5|-4.1|<0.0001
70893444|NCT01458574|141273261|SUPERIORITY_OR_OTHER||Difference in percentage|40.1|||<|0.0001|TWO_SIDED|95.0|25.0|55.3|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||55.3|25.0|<0.0001
70893445|NCT01458574|141273261|SUPERIORITY_OR_OTHER||Difference in percentage|48.4|||<|0.0001|TWO_SIDED|95.0|32.7|64.1|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||64.1|32.7|<0.0001
70893446|NCT01458574|141273261|SUPERIORITY_OR_OTHER||Difference in percentage|36.0|||<|0.0001|TWO_SIDED|95.0|21.6|50.3|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||50.3|21.6|<0.0001
70893447|NCT01458574|141273261|SUPERIORITY_OR_OTHER||Difference in percentage|46.2|||<|0.0001|TWO_SIDED|95.0|31.0|61.4|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||61.4|31.0|<0.0001
70893448|NCT01458574|141273262|SUPERIORITY_OR_OTHER||Difference in percentage|31.8|||<|0.0001|TWO_SIDED|95.0|18.8|44.8|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||44.8|18.8|<0.0001
70893449|NCT01458574|141273262|SUPERIORITY_OR_OTHER||Difference in percentage|42.2|||<|0.0001|TWO_SIDED|95.0|27.9|56.5|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||56.5|27.9|<0.0001
70893450|NCT01458574|141273263|SUPERIORITY_OR_OTHER||Difference in percentage|38.6|||<|0.0001|TWO_SIDED|95.0|23.4|53.8|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||53.8|23.4|<0.0001
70893451|NCT01458574|141273263|SUPERIORITY_OR_OTHER||Difference in percentage|48.4|||<|0.0001|TWO_SIDED|95.0|32.7|64.1|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||64.1|32.7|<0.0001
70893452|NCT01458574|141273263|SUPERIORITY_OR_OTHER||Difference in percentage|34.4|||<|0.0001|TWO_SIDED|95.0|20.1|48.8|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||48.8|20.1|<0.0001
70893453|NCT01458574|141273263|SUPERIORITY_OR_OTHER||Difference in percentage|46.2|||<|0.0001|TWO_SIDED|95.0|31.0|61.4|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||61.4|31.0|<0.0001
70893454|NCT01458574|141273264|SUPERIORITY_OR_OTHER||Difference in percentage|12.9||||0.0074|TWO_SIDED|95.0|2.6|23.2|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||23.2|2.6|0.0074
70893455|NCT01458574|141273264|SUPERIORITY_OR_OTHER||Difference in percentage|13.2||||0.0103|TWO_SIDED|95.0|2.4|24.1|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||24.1|2.4|0.0103
70893456|NCT01458574|141273264|SUPERIORITY_OR_OTHER||Difference in percentage|16.8||||0.0018|TWO_SIDED|95.0|6.2|27.5|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||27.5|6.2|0.0018
70893457|NCT01458574|141273264|SUPERIORITY_OR_OTHER||Difference in percentage|16.7||||0.0029|TWO_SIDED|95.0|5.5|27.9|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||27.9|5.5|0.0029
70893458|NCT01458574|141273265|SUPERIORITY_OR_OTHER||Difference in percentage|7.9||||0.0419|TWO_SIDED|95.0|0.1|15.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||15.7|0.1|0.0419
70963619|NCT04427501|141432108|SUPERIORITY||Odds Ratio (OR)|1.32||||0.291|TWO_SIDED|95.0|0.79|2.2|||Regression, Logistic|||||2.20|0.79|0.291
70963620|NCT04427501|141432108|SUPERIORITY||Odds Ratio (OR)|1.45||||0.143|TWO_SIDED|95.0|0.88|2.4|||Regression, Logistic|||||2.40|0.88|0.143
70893459|NCT01458574|141273265|SUPERIORITY_OR_OTHER||Difference in percentage|11.1||||0.0121|TWO_SIDED|95.0|2.3|19.9|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||19.9|2.3|0.0121
70893460|NCT04964089|141273299|NON_INFERIORITY|The maximum clinically acceptable true difference between KSI-301 and aflibercept participants to be considered non-inferior is 4.5 ETDRS letters, i.e. the non-inferiority margin (NI) is 4.5 letters.|Adjusted mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.91||0.0083|TWO_SIDED|95.03|-3.88|-0.29|||Mixed Models Analysis|MMRM model with treatment, visit, treatment by visit interaction, randomization stratification factors, and continuous baseline BCVA as covariates.||||-0.29|-3.88|0.0083
70893461|NCT01682837|141273306|SUPERIORITY_OR_OTHER|||||||0.07|||||||Mixed Models Analysis|||||||0.07
70893462|NCT01682837|141273307|SUPERIORITY_OR_OTHER|||||||0.2|||||||Mixed Models Analysis|||||||0.20
70893463|NCT01682837|141273308|SUPERIORITY_OR_OTHER|||||||0.16|||||||Mixed Models Analysis|||||||0.16
70893464|NCT01682837|141273309|SUPERIORITY_OR_OTHER|||||||0.7|||||||Mixed Models Analysis|||||||0.70
70893465|NCT01682837|141273310|SUPERIORITY_OR_OTHER|||||||0.42|||||||Mixed Models Analysis|||||||0.42
70893466|NCT01682837|141273311|SUPERIORITY_OR_OTHER|||||||0.1|||||||Mixed Models Analysis|||||||0.10
70893467|NCT01682837|141273312|SUPERIORITY_OR_OTHER|||||||0.64|||||||Mixed Models Analysis|||||||0.64
70893468|NCT01682837|141273313|SUPERIORITY_OR_OTHER|||||||0.18|||||||Mixed Models Analysis|||||||0.18
70893469|NCT01682837|141273314|SUPERIORITY_OR_OTHER|||||||0.12|||||||Mixed Models Analysis|||||||0.12
70893470|NCT01365494|141273340|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be achieved if the lower limit of the two-sided 95% CI of the post vaccination (day 14) ratio of GMCs between the groups (GMCGroup Zagreb / GMCGroup Essen) was greater than 0.667|Ratio of GMCs-Zagreb and Essen at day 14|1.03|||||TWO_SIDED|95.0|0.89|1.19|||ANOVA|||To demonstrate non-inferiority in immune response of the Zagreb postexposure schedule of Rabipur to that of the conventional Essen postexposure schedule at study day 14||1.19|0.89|
70893471|NCT01365494|141273342|SUPERIORITY_OR_OTHER||Ratio of GMCs-Zagreb and Essen at day 7|0.38|||||TWO_SIDED|95.0|0.3|0.48|||ANOVA|||||0.48|0.3|
70893472|NCT01365494|141273342|SUPERIORITY_OR_OTHER||Ratio of GMCs-Zagreb and Essen at day 42|0.96||||||95.0|0.86|1.07|||ANOVA|||||1.07|0.86|
70893473|NCT03086447|141273350|OTHER|It was deemed that a total of 135 subjects in the Test group is sufficient to demonstrate statistical acceptance of monocular VA better than equal to 20/40 with a minimum of 90% statistical power using the reference incidence rate of 95% with a correlation of 0.8 between eyes.|Proportion|100.0|||||TWO_SIDED|95.0|96.5|100.0||All primary hypotheses were simultaneously evaluated using a significance level of 0.05 following the intersection-union principal. All primary hypotheses must be met to claim success of the study objectives.|Binomial proportion with Agresti-Coull||All eyes (100%) in the Test group had acceptable VA throughout the study.|Proportion of eyes with overall acceptable VA assessed throughout the study period (up to 4-week) in the Test group was compared to the historical control acceptable rate of 80%. Lower 95% confidence limit was compared to 0.8.||100|96.5|
70893474|NCT03086447|141273351|OTHER|It was deemed that a total of 135 subjects in the Test group is sufficient to demonstrate statistical acceptance of lens fit with a minimum of 90% statistical power using the reference incidence rate of 95% with a correlation of 0.8 between eyes.|Proportion|100.0|||||TWO_SIDED|95.0|96.5|100.0||All primary hypotheses were simultaneously evaluated using a significance level of 0.05 following the intersection-union principal. All primary hypotheses must be met to claim success of the study objectives.|Binomial proportion with Agrestic-Coull||All eyes (100%) in the Test group had acceptable lens fit at fitting (visit 1).|Proportion of eyes with acceptable lens fit assessed at fitting (visit 1) in the Test group was compared to the historical control rate of 80%. Lower 95% confidence limit was compared to 0.8.||100.0|96.5|
70893475|NCT03086447|141273352|OTHER|It was deemed that a total of 135 subjects in the Test group is sufficient to demonstrate statistical acceptance of lens stability with a minimum of 90% statistical power using the reference incidence rate of 95% with a correlation of 0.8 between eyes.|Proportion|100.0|||||TWO_SIDED|95.0|96.5|100.0||All primary hypotheses were simultaneously evaluated using a significance level of 0.05 following the intersection-union principal. All primary hypotheses must be met to claim success of the study objectives.|Binomial proportion with Agrestic-Coull||All eyes (100%) in the Test group had acceptable stability at fitting.|Proportion of eyes with acceptable stability assessed at fitting (visit 1) in the Test group was compared to the historical control rate of 80%. Lower 95% confidence limit was compared to 0.8.||100.0|96.5|
70893476|NCT03086447|141273353|OTHER|It was deemed that a total of 135 subjects in the Test group is sufficient to demonstrate statistical acceptance of absolute rotation with a minimum of 90% statistical power using the reference incidence rate of 95% with a correlation of 0.8 between eyes.|Least square mean proportion|99.6|||||TWO_SIDED|95.0|97.5|99.9||All primary hypotheses were simultaneously evaluated using a significance level of 0.05 following the intersection-union principal. All primary hypotheses must be met to claim success of the study objectives.|Linear mixed model with binomial dist.||Above 80% of eyes in the Test group had acceptable rotation.|Proportion of eyes with acceptable absolute rotation assessed at 15-minute upon insertion (fitting, visit 1) in the Test group was compared to the historical control rate of 80%. Lower 95% confidence limit was compared to 0.8.||99.9|97.5|
70893477|NCT03086447|141273354|OTHER|It was deemed that a total of 135 subjects per each study group is sufficient to demonstrate no statistical difference in the CS incidence rate between the Test and Control groups with a minimum of 80% statistical power using the reference incidence rate of 0.005% with a correlation of 0.3 between eyes within subject.|Odds Ratio (OR)|0.29|||||TWO_SIDED|95.0|0.004|1.437||All primary hypotheses were simultaneously evaluated using a significance level of 0.05 following the intersection-union principal. All primary hypotheses must be met to claim success of the study objectives.|Bayesian beta-binomial model|A 95% credible interval for the posterior estimate (Test over Control) was used to test no difference between the Test and Control groups.|odds ratio calculated as Test over Control|Proportion of eyes with unacceptable corneal staining (CS) throughout all planned and unplanned visits in the Test group was compared to that in the Control group.||1.437|0.004|
70963621|NCT04427501|141432109|SUPERIORITY||Odds Ratio (OR)|1.89||||0.014|TWO_SIDED|95.0|1.14|3.15|||Regression, Logistic|||||3.15|1.14|0.014
70963622|NCT04427501|141432109|SUPERIORITY||Odds Ratio (OR)|1.06||||0.828|TWO_SIDED|95.0|0.64|1.74|||Regression, Logistic|||||1.74|0.64|0.828
70893478|NCT03086447|141273355|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE score.|Mean Difference (Final Values)|6.8|STANDARD_DEVIATION|2.39|||TWO_SIDED|95.0|2.1|11.5|||Linear mixed model|A 95% confidence interval for the least square mean difference was used to demonstrate non-inferiority of the Test relative to the Control groups.|Mean difference was calculated as Test minus Control|Sample size calculation was performed considering the effect size of 5 (Test minus Control) to achieve a minimum statistical power of 90% at a 5% significance level.||11.5|2.1|
70893479|NCT03086447|141273356|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE score.|Mean Difference (Final Values)|-3.1|STANDARD_DEVIATION|2.04|||TWO_SIDED|95.0|-7.2|0.9|||Linear mixed model|A 95% confidence interval for the least square mean difference was used to demonstrate non-inferiority of the Test relative to the Control groups.|Mean difference was calculated as Test minus Control|Sample size calculation was performed considering the effect size of 5 (Test minus Control) to achieve a minimum statistical power of 90% at a 5% significance level.||0.9|-7.2|
70893480|NCT03086447|141273357|NON_INFERIORITY|A non-inferiority margin of 0.5 was used. This margin is based on a 10% difference in the distribution between the Test and Control groups.|Odds Ratio (OR)|1.77|||||TWO_SIDED|95.0|0.98|3.22|||Generalized LMM w/ binomial dist.||Odds ratio of Test over Control was calculated.|Proportion of eyes with optimal VA assessed at fitting in the Test group was compared to the Control group.||3.22|0.98|
70893481|NCT03394924|141273369|SUPERIORITY||Odds Ratio (OR)|5.6||||0.106|TWO_SIDED|95.0|0.6|52.0|||Cochran-Mantel-Haenszel|||||52|0.6|0.106
70893482|NCT03394924|141273369|SUPERIORITY||Odds Ratio (OR)|7.0||||0.063|TWO_SIDED|95.0|0.75|65.22|||Cochran-Mantel-Haenszel|||||65.22|0.75|0.063
70893483|NCT03394924|141273373|SUPERIORITY||Least squares mean difference|0.47||||0.616|TWO_SIDED|95.0|-1.39|2.32|||ANCOVA|||Analysis for total bilirubin.||2.32|-1.39|0.616
70893484|NCT03394924|141273373|SUPERIORITY||Least squares mean difference|0.19||||0.844|TWO_SIDED|95.0|-1.78|2.16|||ANCOVA|||Analysis for total bilirubin.||2.16|-1.78|0.844
70893485|NCT03394924|141273373|SUPERIORITY||Least squares mean difference|-0.67||||0.18|TWO_SIDED|95.0|-1.67|0.32|||ANCOVA|||Analysis for conjugated bilirubin.||0.32|-1.67|0.18
70893486|NCT03394924|141273373|SUPERIORITY||Least squares mean difference|-0.64||||0.239|TWO_SIDED|95.0|-1.71|0.44|||ANCOVA|||Analysis for conjugated bilirubin.||0.44|-1.71|0.239
70893487|NCT03394924|141273373|SUPERIORITY||Least squares mean difference|1.21||||0.116|TWO_SIDED|95.0|-0.31|2.73|||ANCOVA|||Analysis for unconjugated bilirubin.||2.73|-0.31|0.116
70893488|NCT03394924|141273373|SUPERIORITY||Least squares mean difference|0.72||||0.36|TWO_SIDED|95.0|-0.84|2.28|||ANCOVA|||Analysis for unconjugated bilirubin.||2.28|-0.84|0.36
70893489|NCT03394924|141273374|SUPERIORITY||Least squares mean difference|-25.55||||0.001|TWO_SIDED|95.0|-40.07|-11.04|||ANCOVA|||Analysis for ALT.||-11.04|-40.07|0.001
70893490|NCT03394924|141273374|SUPERIORITY||Least squares mean difference|-21.35||||0.009|TWO_SIDED|95.0|-37.1|-5.6|||ANCOVA|||Analysis for ALT.||-5.6|-37.1|0.009
70893491|NCT03394924|141273374|SUPERIORITY||Least squares mean difference|-21.42||||0|TWO_SIDED|95.0|-32.48|-10.35|||ANCOVA|||Analysis for AST.||-10.35|-32.48|0.000
70893492|NCT03394924|141273374|SUPERIORITY||Least squares mean difference|-20.84||||0.001|TWO_SIDED|95.0|-32.8|-8.87|||ANCOVA|||Analysis for AST.||-8.87|-32.8|0.001
70893493|NCT03394924|141273374|SUPERIORITY||Least squares mean difference|-86.49||||0|TWO_SIDED|95.0|-123.78|-49.21|||ANCOVA|||Analysis for GGT.||-49.21|-123.78|0.000
70893494|NCT03394924|141273374|SUPERIORITY||Least squares mean difference|-115.13||||0|TWO_SIDED|95.0|-155.04|-75.22|||ANCOVA|||Analysis for GGT.||-75.22|-155.04|0.000
70893495|NCT03394924|141273375|SUPERIORITY||Least squares mean difference|-26.66||||0.148|TWO_SIDED|95.0|-63.1|9.79|||ANCOVA|||Analysis for HA.||9.79|-63.1|0.148
70893496|NCT03394924|141273375|SUPERIORITY||Least squares mean difference|-28.99||||0.142|TWO_SIDED|95.0|-68.02|10.05|||ANCOVA|||Analysis for HA.||10.05|-68.02|0.142
70893497|NCT03394924|141273375|SUPERIORITY||Least squares mean difference|-3.09||||0.02|TWO_SIDED|95.0|-5.68|-0.51|||ANCOVA|||Analysis for PIIINP.||-0.51|-5.68|0.02
70893498|NCT03394924|141273375|SUPERIORITY||Least squares mean difference|-3.79||||0.009|TWO_SIDED|95.0|-6.6|-0.97|||ANCOVA|||Analysis for PIIINP.||-0.97|-6.6|0.009
70893499|NCT03394924|141273375|SUPERIORITY||Least squares mean difference|-41.96||||0.015|TWO_SIDED|95.0|-75.47|-8.44|||ANCOVA|||Analysis for TIMP 1.||-8.44|-75.47|0.015
70893500|NCT03394924|141273375|SUPERIORITY||Least squares mean difference|-46.56||||0.011|TWO_SIDED|95.0|-81.91|-11.21|||ANCOVA|||Analysis for TIMP 1.||-11.21|-81.91|0.011
70893501|NCT03394924|141273375|SUPERIORITY||Least squares mean difference|-9.73||||0.018|TWO_SIDED|95.0|-17.7|-1.75|||ANCOVA|||Analysis for PRO C3.||-1.75|-17.7|0.018
70893502|NCT03394924|141273375|SUPERIORITY||Least squares mean difference|-6.73||||0.125|TWO_SIDED|95.0|-15.41|1.95|||ANCOVA|||Analysis for PRO C3.||1.95|-15.41|0.125
70893503|NCT03394924|141273376|SUPERIORITY||Least squares mean difference|-0.37||||0|TWO_SIDED|95.0|-0.56|-0.18|||ANCOVA|||||-0.18|-0.56|0.000
70893504|NCT03394924|141273376|SUPERIORITY||Least squares mean difference|-0.33||||0.002|TWO_SIDED|95.0|-0.54|-0.13|||ANCOVA|||||-0.13|-0.54|0.002
70893505|NCT03394924|141273377|SUPERIORITY||Least squares mean difference|-0.35||||0.026|TWO_SIDED|95.0|-0.65|-0.04|||ANCOVA|||||-0.04|-0.65|0.026
70893506|NCT03394924|141273377|SUPERIORITY||Least squares mean difference|-0.26||||0.104|TWO_SIDED|95.0|-0.57|0.05|||ANCOVA|||||0.05|-0.57|0.104
70893507|NCT03394924|141273378|SUPERIORITY||Least squares mean difference|6.81||||0.757|TWO_SIDED|95.0|-37.17|50.78|||ANCOVA|||Analysis for fibrinogen.||50.78|-37.17|0.757
70893508|NCT03394924|141273378|SUPERIORITY||Least squares mean difference|31.77||||0.174|TWO_SIDED|95.0|-14.42|77.97|||ANCOVA|||Analysis for fibrinogen.||77.97|-14.42|0.174
70893509|NCT03394924|141273378|SUPERIORITY||Least squares mean difference|-0.98||||0.378|TWO_SIDED|95.0|-3.18|1.23|||ANCOVA|||Analysis for CRP.||1.23|-3.18|0.378
70893510|NCT03394924|141273378|SUPERIORITY||Least squares mean difference|-3.1||||0.008|TWO_SIDED|95.0|-5.38|-0.83|||ANCOVA|||Analysis for CRP.||-0.83|-5.38|0.008
70893511|NCT03394924|141273379|SUPERIORITY||Least squares mean difference|0.34||||0.841|TWO_SIDED|95.0|-3.07|3.76|||ANCOVA|||Analysis for IL6.||3.76|-3.07|0.841
70893512|NCT03394924|141273379|SUPERIORITY||Least squares mean difference|-2.49||||0.163|TWO_SIDED|95.0|-6.01|1.04|||ANCOVA|||Analysis for IL6.||1.04|-6.01|0.163
70893513|NCT03394924|141273379|SUPERIORITY||Least squares mean difference|-0.53||||0.03|TWO_SIDED|95.0|-1.02|-0.05|||ANCOVA|||Analysis for TNF α.||-0.05|-1.02|0.03
70893514|NCT03394924|141273379|SUPERIORITY||Least squares mean difference|-0.4||||0.11|TWO_SIDED|95.0|-0.9|0.09|||ANCOVA|||Analysis for TNF α.||0.09|-0.9|0.11
70893515|NCT03394924|141273380|SUPERIORITY||Least squares mean difference|0.01||||0.944|TWO_SIDED|95.0|-0.25|0.27|||ANCOVA|||Analysis for haptoglobin.||0.27|-0.25|0.944
70893516|NCT03394924|141273380|SUPERIORITY||Least squares mean difference|-0.03||||0.83|TWO_SIDED|95.0|-0.3|0.24|||ANCOVA|||Analysis for haptoglobin.||0.24|-0.3|0.83
70893517|NCT03394924|141273380|SUPERIORITY||Least squares mean difference|-0.04||||0.546|TWO_SIDED|95.0|-0.19|0.1|||ANCOVA|||Analysis for alpha2 macroglobulin.||0.1|-0.19|0.546
70893518|NCT03394924|141273380|SUPERIORITY||Least squares mean difference|-0.02||||0.785|TWO_SIDED|95.0|-0.18|0.13|||ANCOVA|||Analysis for alpha2 macroglobulin.||0.13|-0.18|0.785
70893519|NCT03394924|141273381|SUPERIORITY||Least squares mean difference|-0.17||||0.176|TWO_SIDED|95.0|-0.43|0.08|||ANCOVA|||Analysis for TG.||0.08|-0.43|0.176
70893520|NCT03394924|141273381|SUPERIORITY||Least squares mean difference|-0.04||||0.783|TWO_SIDED|95.0|-0.3|0.23|||ANCOVA|||Analysis for TG.||0.23|-0.3|0.783
70893521|NCT03394924|141273381|SUPERIORITY||Least squares mean difference|-0.64||||0.061|TWO_SIDED|95.0|-1.31|0.03|||ANCOVA|||Analysis for TC.||0.03|-1.31|0.061
70893522|NCT03394924|141273381|SUPERIORITY||Least squares mean difference|-0.63||||0.08|TWO_SIDED|95.0|-1.34|0.08|||ANCOVA|||Analysis for TC.||0.08|-1.34|0.08
70893523|NCT03394924|141273381|SUPERIORITY||Least squares mean difference|0.08||||0.584|TWO_SIDED|95.0|-0.21|0.37|||ANCOVA|||Analysis for HDL-C.||0.37|-0.21|0.584
70893524|NCT03394924|141273381|SUPERIORITY||Least squares mean difference|-0.22||||0.148|TWO_SIDED|95.0|-0.51|0.08|||ANCOVA|||Analysis for HDL-C.||0.08|-0.51|0.148
70893525|NCT03394924|141273381|SUPERIORITY||Least squares mean difference|-0.5||||0.074|TWO_SIDED|95.0|-1.04|0.05|||ANCOVA|||Analysis for LDL-C.||0.05|-1.04|0.074
70893526|NCT03394924|141273381|SUPERIORITY||Least squares mean difference|-0.3||||0.304|TWO_SIDED|95.0|-0.87|0.28|||ANCOVA|||Analysis for LDL-C.||0.28|-0.87|0.304
70893527|NCT03394924|141273382|SUPERIORITY||Least squares mean difference|0.25||||0.378|TWO_SIDED|95.0|-0.32|0.82|||ANCOVA|||Analysis for duration.||0.82|-0.32|0.378
70893528|NCT03394924|141273382|SUPERIORITY||Least squares mean difference|0.65||||0.03|TWO_SIDED|95.0|0.07|1.23|||ANCOVA|||Analysis for duration.||1.23|0.07|0.03
70893529|NCT03394924|141273382|SUPERIORITY||Least squares mean difference|0.53||||0.036|TWO_SIDED|95.0|0.04|1.03|||ANCOVA|||Analysis for degree.||1.03|0.04|0.036
70893530|NCT03394924|141273382|SUPERIORITY||Least squares mean difference|1.18||||0|TWO_SIDED|95.0|0.67|1.69|||ANCOVA|||Analysis for degree.||1.69|0.67|0.000
70893531|NCT03394924|141273382|SUPERIORITY||Least squares mean difference|0.02||||0.971|TWO_SIDED|95.0|-0.92|0.96|||ANCOVA|||Analysis for direction.||0.96|-0.92|0.971
70893532|NCT03394924|141273382|SUPERIORITY||Least squares mean difference|1.01||||0.042|TWO_SIDED|95.0|0.04|1.99|||ANCOVA|||Analysis for direction.||1.99|0.04|0.042
70893533|NCT03394924|141273382|SUPERIORITY||Least squares mean difference|0.37||||0.336|TWO_SIDED|95.0|-0.4|1.14|||ANCOVA|||Analysis for disability.||1.14|-0.4|0.336
70893534|NCT03394924|141273382|SUPERIORITY||Least squares mean difference|1.46||||0|TWO_SIDED|95.0|0.67|2.26|||ANCOVA|||Analysis for disability.||2.26|0.67|0.000
70893535|NCT03394924|141273382|SUPERIORITY||Least squares mean difference|0.48||||0.214|TWO_SIDED|95.0|-0.29|1.25|||ANCOVA|||Analysis for distribution.||1.25|-0.29|0.214
70893536|NCT03394924|141273382|SUPERIORITY||Least squares mean difference|1.23||||0.003|TWO_SIDED|95.0|0.44|2.02|||ANCOVA|||Analysis for distribution.||2.02|0.44|0.003
70893537|NCT03394924|141273382|SUPERIORITY||Least squares mean difference|2.21||||0.103|TWO_SIDED|95.0|-0.47|4.9|||ANCOVA|||Analysis for total.||4.9|-0.47|0.103
70893538|NCT03394924|141273382|SUPERIORITY||Least squares mean difference|6.35||||0|TWO_SIDED|95.0|3.57|9.13|||ANCOVA|||Analysis for total.||9.13|3.57|0.000
70893539|NCT03394924|141273383|SUPERIORITY||Least squares mean difference|12.48||||0.16|TWO_SIDED|95.0|-5.09|30.06|||ANCOVA|||||30.06|-5.09|0.16
70893540|NCT03394924|141273383|SUPERIORITY||Least squares mean difference|25.58||||0.006|TWO_SIDED|95.0|7.67|43.48|||ANCOVA|||||43.48|7.67|0.006
70893541|NCT03394924|141273384|SUPERIORITY||Least squares mean difference|-0.15||||0.908|TWO_SIDED|95.0|-2.72|2.43|||ANCOVA|||Analysis for symptoms.||2.43|-2.72|0.908
70893542|NCT03394924|141273384|SUPERIORITY||Least squares mean difference|-1.41||||0.298|TWO_SIDED|95.0|-4.09|1.27|||ANCOVA|||Analysis for symptoms.||1.27|-4.09|0.298
70893543|NCT03394924|141273384|SUPERIORITY||Least squares mean difference|1.91||||0.042|TWO_SIDED|95.0|0.07|3.76|||ANCOVA|||Analysis for itch.||3.76|0.07|0.042
70893544|NCT03394924|141273384|SUPERIORITY||Least squares mean difference|3.47||||0.001|TWO_SIDED|95.0|1.55|5.38|||ANCOVA|||Analysis for itch.||5.38|1.55|0.001
70893545|NCT03394924|141273384|SUPERIORITY||Least squares mean difference|-0.46||||0.839|TWO_SIDED|95.0|-4.96|4.04|||ANCOVA|||Analysis for fatigue.||4.04|-4.96|0.839
70893546|NCT03394924|141273384|SUPERIORITY||Least squares mean difference|-0.32||||0.891|TWO_SIDED|95.0|-5.0|4.36|||ANCOVA|||Analysis for fatigue.||4.36|-5.00|0.891
70893547|NCT03394924|141273384|SUPERIORITY||Least squares mean difference|0.26||||0.834|TWO_SIDED|95.0|-2.25|2.77|||ANCOVA|||Analysis for cognition.||2.77|-2.25|0.834
70893548|NCT03394924|141273384|SUPERIORITY||Least squares mean difference|1.3||||0.327|TWO_SIDED|95.0|-1.33|3.92|||ANCOVA|||Analysis for cognition.||3.92|-1.33|0.327
70893549|NCT03394924|141273384|SUPERIORITY||Least squares mean difference|-2.12||||0.262|TWO_SIDED|95.0|-5.86|1.62|||ANCOVA|||Analysis for social.||1.62|-5.86|0.262
70893550|NCT03394924|141273384|SUPERIORITY||Least squares mean difference|-0.78||||0.69|TWO_SIDED|95.0|-4.68|3.12|||ANCOVA|||Analysis for social.||3.12|-4.68|0.69
70893551|NCT03394924|141273384|SUPERIORITY||Least squares mean difference|-0.62||||0.433|TWO_SIDED|95.0|-2.19|0.95|||ANCOVA|||Analysis for emotional.||0.95|-2.19|0.433
70893552|NCT03394924|141273384|SUPERIORITY||Least squares mean difference|0.37||||0.653|TWO_SIDED|95.0|-1.28|2.03|||ANCOVA|||Analysis for emotional.||2.03|-1.28|0.653
70893553|NCT03394924|141273388|SUPERIORITY||Least squares mean difference|1.34||||0.971|TWO_SIDED|95.0|-71.51|74.18|||ANCOVA|||Analysis for FGF19.||74.18|-71.51|0.971
70893554|NCT03394924|141273388|SUPERIORITY||Least squares mean difference|5.54||||0.882|TWO_SIDED|95.0|-68.86|79.95|||ANCOVA|||Analysis for FGF19.||79.95|-68.86|0.882
70893555|NCT03394924|141273388|SUPERIORITY||Least squares mean difference|-51.66||||0.242|TWO_SIDED|95.0|-139.27|35.96|||ANCOVA|||Analysis for C4.||35.96|-139.27|0.242
70893556|NCT03394924|141273388|SUPERIORITY||Least squares mean difference|-94.3||||0.042|TWO_SIDED|95.0|-184.85|-3.75|||ANCOVA|||Analysis for C4.||-3.75|-184.85|0.042
70893557|NCT03394924|141273388|SUPERIORITY||Least squares mean difference|-24.57||||0.52|TWO_SIDED|95.0|-101.03|51.89|||ANCOVA|||Analysis for BA.||51.89|-101.03|0.52
70893558|NCT03394924|141273388|SUPERIORITY||Least squares mean difference|-17.96||||0.672|TWO_SIDED|95.0|-103.07|67.16|||ANCOVA|||Analysis for BA.||67.16|-103.07|0.672
70893559|NCT03394924|141273389|SUPERIORITY||Least squares mean difference|44.54||||0.611|TWO_SIDED|95.0|-205.97|295.06|||ANCOVA|||Analysis for FGF19 AUC0-8.||295.06|-205.97|0.611
70893560|NCT03394924|141273389|SUPERIORITY||Least squares mean difference|-29.98||||0.819|TWO_SIDED|95.0|-411.28|351.31|||ANCOVA|||Analysis for FGF19 AUC0-8.||351.31|-411.28|0.819
70893561|NCT03394924|141273389|SUPERIORITY||Least squares mean difference|24.41||||0.818|TWO_SIDED|95.0|-251.92|300.74|||ANCOVA|||Analysis for FGF19 AUC2-8.||300.74|-251.92|0.818
70893562|NCT03394924|141273389|SUPERIORITY||Least squares mean difference|-10.53||||0.948|TWO_SIDED|95.0|-435.33|414.27|||ANCOVA|||Analysis for FGF19 AUC2-8.||414.27|-435.33|0.948
70893563|NCT03394924|141273389|SUPERIORITY||Least squares mean difference|-91.7||||0.412|TWO_SIDED|95.0|-475.92|292.51|||ANCOVA|||Analysis for C4 AUC0-8.||292.51|-475.92|0.412
70893564|NCT03394924|141273389|SUPERIORITY||Least squares mean difference|-250.18||||0.094|TWO_SIDED|95.0|-605.33|104.98|||ANCOVA|||Analysis for C4 AUC0-8.||104.98|-605.33|0.094
70893565|NCT03394924|141273389|SUPERIORITY||Least squares mean difference|-83.7||||0.266|TWO_SIDED|95.0|-279.15|111.75|||ANCOVA|||Analysis for C4 AUC2-8.||111.75|-279.15|0.266
70893566|NCT03394924|141273389|SUPERIORITY||Least squares mean difference|-238.19||||0.047|TWO_SIDED|95.0|-470.22|-6.15|||ANCOVA|||Analysis for C4 AUC2-8.||-6.15|-470.22|0.047
70893567|NCT03394924|141273389|SUPERIORITY||Least squares mean difference|28.41||||0.694|TWO_SIDED|95.0|-180.2|237.02|||ANCOVA|||Analysis for BA AUC0-8.||237.02|-180.2|0.694
70893568|NCT03394924|141273389|SUPERIORITY||Least squares mean difference|-39.5||||0.615|TWO_SIDED|95.0|-264.32|185.32|||ANCOVA|||Analysis for BA AUC0-8.||185.32|-264.32|0.615
70893569|NCT03394924|141273389|SUPERIORITY||Least squares mean difference|2.93||||0.974|TWO_SIDED|95.0|-229.6|235.46|||ANCOVA|||Analysis for BA AUC2-8.||235.46|-229.6|0.974
70893570|NCT03394924|141273389|SUPERIORITY||Least squares mean difference|-26.05||||0.793|TWO_SIDED|95.0|-283.24|231.15|||ANCOVA|||Analysis for BA AUC2-8.||231.15|-283.24|0.793
70893571|NCT00364858|141273403|SUPERIORITY_OR_OTHER||Agresti and Min|-0.176||||||95.0|-0.357|0.058||||||Difference in proportion of Clinical Success = (Proportion of participants with Clinical Success Q4 - Proportion of participants with Clinical Success Q2).||0.058|-0.357|
70893572|NCT00627705|141273408|SUPERIORITY_OR_OTHER|||||||0.449|||||||mixed effects regression models|F= 0.81||Cohen's d = 0.30||||0.449
70893573|NCT00627705|141273410|SUPERIORITY_OR_OTHER||||||<|0.001||||||Aberrant Behavior Checklist irritability subscale (F = 6.80; p = \<.001; d = .96).|Mixed effects regression models|||F values were derived from the interaction of participant group (NAC vs. placebo) and time (week) in mixed effects regression models. Cohen's d was computed based on the standardized mean difference in the change from baseline to week 12.||||<.001
70893574|NCT00627705|141273412|SUPERIORITY_OR_OTHER|||||||0.141|||||||mixed effects regression models|degrees of freedom were 1, 22||F-values were derived from the interaction of Participant Group (NAC vs. Placebo) and Time (Week) in mixed effects regression models.||||.141
70893575|NCT03069482|141273504|SUPERIORITY||Slope|1.063|STANDARD_DEVIATION|3.377|=|0.754|TWO_SIDED||||||ANOVA|||||||=0.754
70893576|NCT03069482|141273505|SUPERIORITY||Risk Ratio (RR)|2.103|STANDARD_DEVIATION|0.369||0.044|TWO_SIDED|95.0|1.2|2.6|||Mixed Models Analysis|Zero inflated negative binomial mixed methods regression.||||2.6|1.2|0.044
70893577|NCT03069482|141273506|OTHER||Percent accrual relative to target N|102.0|||||TWO_SIDED||||||||||The goal of this outcome was to determine whether the trial could reach its enrollment target (90 participants).|||
70893578|NCT03069482|141273507|OTHER||Percent retention relative to target|98.3|||||TWO_SIDED||||||||||We calculated the percent of retained participants relative to the retention target (N = 62)|||
70893579|NCT03069482|141273508|OTHER||Percent of respondents|58.0|||||TWO_SIDED|||||||||||||
70893580|NCT03069482|141273510|SUPERIORITY||Trimmed mean difference|8.29574|STANDARD_ERROR_OF_MEAN|2.11||0.046|TWO_SIDED|95.0|0.138|16.453|||Yuen's trimmed mean t-test|||||16.453|0.138|0.046
70893581|NCT03069482|141273511|SUPERIORITY||Trimmed mean difference|7.79514|STANDARD_ERROR_OF_MEAN|2.16||0.109|TWO_SIDED|95.0|-1.867|17.457|||Yuen's trimmed means t-test|||||17.457|-1.867|0.109
70893582|NCT03069482|141273512|SUPERIORITY||Trimmed mean difference|2.22222|STANDARD_ERROR_OF_MEAN|1.75||0.50537|TWO_SIDED|95.0|-4.492|8.943|||Yuen's trimmed means t-test|||||8.943|-4.492|0.50537
70893583|NCT03069482|141273513|SUPERIORITY||Trimmed mean difference|5.83333|STANDARD_ERROR_OF_MEAN|2.3||0.27411|TWO_SIDED|95.0|-4.88|16.54|||Yuen's trimmed means t-test|||||16.54|-4.88|0.27411
70893584|NCT04537923|141273559|NON_INFERIORITY|0.3% noninferiority margin.|LS Mean Difference|-1.1|||<|0.001|TWO_SIDED|95.0|-1.24|-0.97|||Mixed Models Analysis|||||-0.97|-1.24|<0.001
70893585|NCT04537923|141273560|NON_INFERIORITY|0.3% noninferiority margin.|LS Mean Difference|-0.89|||<|0.001|TWO_SIDED|95.0|-1.08|-0.7|||Mixed Models Analysis|||||-0.70|-1.08|<0.001
70893586|NCT04537923|141273560|NON_INFERIORITY|0.3% noninferiority margin.|LS Mean Difference|-1.11|||<|0.001|TWO_SIDED|95.0|-1.3|-0.92|||Mixed Models Analysis|||||-0.92|-1.30|<0.001
70893587|NCT04537923|141273560|NON_INFERIORITY|0.3% noninferiority margin.|LS Mean Difference|-1.3|||<|0.001|TWO_SIDED|95.0|-1.49|-1.11|||Mixed Models Analysis|||||-1.11|-1.49|<0.001
70893588|NCT04537923|141273561|SUPERIORITY||Odds Ratio (OR)|3.13|||<|0.0001|TWO_SIDED|95.0|2.25|4.36|||Regression, Logistic|||||4.36|2.25|<0.0001
70893589|NCT04537923|141273561|SUPERIORITY||Odds Ratio (OR)|6.16|||<|0.0001|TWO_SIDED|95.0|4.27|8.88|||Regression, Logistic|||||8.88|4.27|<0.0001
70893590|NCT04537923|141273561|SUPERIORITY||Odds Ratio (OR)|7.94|||<|0.0001|TWO_SIDED|95.0|5.37|11.75|||Regression, Logistic|||||11.75|5.37|<0.0001
70893591|NCT04537923|141273562|SUPERIORITY||LS Mean Difference|-10.7|||<|0.001|TWO_SIDED|95.0|-11.5|-9.9|||Mixed Models Analysis|||||-9.9|-11.5|<0.001
70893592|NCT04537923|141273562|SUPERIORITY||LS Mean Difference|-13.7|||<|0.001|TWO_SIDED|95.0|-14.5|-12.9|||Mixed Models Analysis|||||-12.9|-14.5|<0.001
70893593|NCT04537923|141273562|SUPERIORITY||LS Mean Difference|-15.9|||<|0.001|TWO_SIDED|95.0|-16.7|-15.0|||Mixed Models Analysis|||||-15.0|-16.7|<0.001
70893594|NCT04537923|141273563|SUPERIORITY||LS Mean Difference|-23.2|||<|0.001|TWO_SIDED|95.0|-30.8|-15.7|||Mixed Models Analysis|||||-15.7|-30.8|<0.001
70893595|NCT04537923|141273563|SUPERIORITY||LS Mean Difference|-33.0|||<|0.001|TWO_SIDED|95.0|-40.6|-25.4|||Mixed Models Analysis|||||-25.4|-40.6|<0.001
70893596|NCT04537923|141273563|SUPERIORITY||LS Mean Difference|-31.6|||<|0.001|TWO_SIDED|95.0|-39.3|-23.8|||Mixed Models Analysis|||||-23.8|-39.3|<0.001
70893597|NCT04537923|141273564|SUPERIORITY||LS Mean Difference|-0.9||||0.682|TWO_SIDED|95.0|-5.0|3.3|||Mixed Models Analysis|||||3.3|-5.0|0.682
70893598|NCT04537923|141273564|SUPERIORITY||LS Mean Difference|-5.6||||0.01|TWO_SIDED|95.0|-9.9|-1.4|||Mixed Models Analysis|||||-1.4|-9.9|0.010
70893599|NCT04537923|141273564|SUPERIORITY||LS Mean Difference|-11.8|||<|0.001|TWO_SIDED|95.0|-16.0|-7.5|||Mixed Models Analysis|||||-7.5|-16.0|<0.001
70893600|NCT04537923|141273565|SUPERIORITY||Odds Ratio (OR)|8.19|||<|0.001|TWO_SIDED|95.0|5.66|11.83|||Regression, Logistic|||||11.83|5.66|<0.001
70893601|NCT04537923|141273565|SUPERIORITY||Odds Ratio (OR)|16.9|||<|0.001|TWO_SIDED|95.0|11.44|24.96|||Regression, Logistic|||||24.96|11.44|<0.001
70893602|NCT04537923|141273565|SUPERIORITY||Odds Ratio (OR)|21.85|||<|0.001|TWO_SIDED|95.0|14.49|32.93|||Regression, Logistic|||||32.93|14.49|<0.001
70893603|NCT04537923|141273566|SUPERIORITY||Odds Ratio (OR)|28.25|||<|0.001|TWO_SIDED|95.0|18.36|43.46|||Regression, Logistic|||||43.46|18.36|<0.001
70893604|NCT04537923|141273566|SUPERIORITY||Odds Ratio (OR)|58.9|||<|0.001|TWO_SIDED|95.0|36.76|94.39|||Regression, Logistic|||||94.39|36.76|<0.001
70893605|NCT04537923|141273566|SUPERIORITY||Odds Ratio (OR)|77.76|||<|0.001|TWO_SIDED|95.0|47.49|127.33|||Regression, Logistic|||||127.33|47.49|<0.001
70893606|NCT04537923|141273567|SUPERIORITY||LS Mean Difference|1.5||||0.005|TWO_SIDED|95.0|0.5|2.6|||ANCOVA|||||2.6|0.5|0.005
70893607|NCT04537923|141273567|SUPERIORITY||LS Mean Difference|2.3|||<|0.001|TWO_SIDED|95.0|1.2|3.3|||ANCOVA|||||3.3|1.2|<0.001
70893608|NCT04537923|141273567|SUPERIORITY||LS Mean Difference|2.2|||<|0.001|TWO_SIDED|95.0|1.2|3.3|||ANCOVA|||||3.3|1.2|<0.001
70893609|NCT04537923|141273568|SUPERIORITY||LS Mean Difference|1.6||||0.02|TWO_SIDED|95.0|0.3|2.9|||ANCOVA|||||2.9|0.3|0.020
70893610|NCT04537923|141273568|SUPERIORITY||LS Mean Difference|2.8|||<|0.001|TWO_SIDED|95.0|1.5|4.2|||ANCOVA|||||4.2|1.5|<0.001
70893611|NCT04537923|141273568|SUPERIORITY||LS Mean Difference|2.1||||0.004|TWO_SIDED|95.0|0.7|3.5|||ANCOVA|||||3.5|0.7|0.004
70893612|NCT01261611|141273569|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANCOVA|An ANCOVA on the change from baseline, baseline TWSTRS Total score, baseline BTX status and pooled centre as explanatory variables was performed.||A pre-specified analysis of the LS mean difference between the Dysport NG and Placebo arms was performed. A total of 210 subjects were included in the analysis.||||<0.0001
70893613|NCT01261611|141273569|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANCOVA|An ANCOVA on the change from baseline, baseline TWSTRS Total score, baseline BTX status and pooled centre as explanatory variables was performed.||A pre-specified analysis of the LS mean difference between the Dysport and Placebo arms was performed. A total of 213 subjects were included in the analysis.||||<0.0001
70893614|NCT01261611|141273569|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An ANCOVA on the change from baseline with treatment, baseline TWSTRS Total score, BTX status at baseline and pooled centre as explanatory variables had been performed. The non-inferiority margin was 3 points.|LS mean difference|1.532|||||TWO_SIDED|95.0|-0.819|3.883||||||A pre-specified analysis of the LS mean difference between the Dysport NG and Dysport arms was performed. A total of 315 subjects were included in the analysis.||3.883|-0.819|
70893615|NCT00920426|141273595|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.09|||<|0.001|TWO_SIDED|95.0|-2.547|-1.632||Analysis of covariance (ANCOVA) with treatment as fixed effect, and Baseline HIV-1 RNA as covariate.|ANCOVA|||||-1.632|-2.547|<0.001
70893616|NCT00920426|141273621|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.804|||<|0.001|TWO_SIDED|95.0|-2.173|-1.436||ANCOVA with treatment as fixed effect, and baseline HIV-1 RNA as covariate.|ANCOVA|||||-1.436|-2.173|<0.001
70893617|NCT00920426|141273622|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70893618|NCT01997398|141273655|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Differences in baseline and 6-month postoperative scores were assessed using a series of repeated measures general linear models with a single within-subjects factor and no between-subjects factors.|Repeated measures general linear models|||||||<0.001
70893619|NCT04389762|141273737|OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
70893620|NCT04389762|141273738|OTHER|||||||0.004|||||||t-test, 2 sided|||||||0.004
70893621|NCT04389762|141273739|OTHER|||||||0.007|||||||t-test, 2 sided|||||||0.007
70893622|NCT04389762|141273740|OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.040
70893623|NCT04389762|141273741|OTHER|||||||0.031|||||||t-test, 2 sided|||||||0.031
70893624|NCT04389762|141273742|OTHER|||||||0.115|||||||t-test, 2 sided|||||||0.115
70893625|NCT04389762|141273743|OTHER|||||||0.031|||||||t-test, 2 sided|||||||0.031
70893626|NCT01259713|141273760|NON_INFERIORITY_OR_EQUIVALENCE|For the interim analysis performed when 50% of the subjects had completed the study, an alpha of 0.0003 was spent. Therefore, the significance level for the 2-sided test in the primary analysis at the end of the study was 0.0497 (corresponding to 95.03% confidence interval (CI)).|Relative risk reduction|0.33||||0.24|TWO_SIDED|95.03|-0.32|0.66||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel||Relative risk reduction = 1 - risk ratio.|A two-group Cochran-Mantel-Haenszel (CMH) test with a 0.05 two-sided significance level and 2:1 allocation of 354 randomized subjects (236 AmBisome, 118 placebo) would have 81% power to detect a relative reduction of 75% if the rate of IFI is 10% in the placebo group (based on unpublished data from the German Multicenter Acute Lymphoblastic Leukemia Working Group (GMALL) and consistent with the published rate of 16.4% in patients with hematological malignancies undergoing remission induction).||0.66|-0.32|0.24
70893627|NCT01259713|141273761|SUPERIORITY_OR_OTHER||Relative risk reduction|0.25||||0.15|TWO_SIDED|95.0|-0.11|0.5||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel||Relative risk reduction = 1 - risk ratio.|||0.50|-0.11|0.15
70893628|NCT01259713|141273762|SUPERIORITY_OR_OTHER||Relative risk reduction|-0.01||||0.97|TWO_SIDED|95.0|-0.94|0.47||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel||Relative risk reduction = 1 - risk ratio.|||0.47|-0.94|0.97
70893629|NCT01259713|141273763|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED|||||The p-value is from the log-rank test stratified by region.|Log Rank|||||||0.33
70963623|NCT04427501|141432109|SUPERIORITY||Odds Ratio (OR)|1.82||||0.022|TWO_SIDED|95.0|1.09|3.02|||Regression, Logistic|||||3.02|1.09|0.022
70893630|NCT01259713|141273764|SUPERIORITY_OR_OTHER||Relative risk reduction|0.25||||0.22|TWO_SIDED|95.0|-0.19|0.53||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel||Relative risk reduction = 1 - risk ratio.|||0.53|-0.19|0.22
70893631|NCT01259713|141273765|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED|||||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel|||||||0.32
70893632|NCT01259713|141273766|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED|||||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel|||||||0.32
70893633|NCT01259713|141273767|SUPERIORITY_OR_OTHER|||||||0.69|TWO_SIDED|||||The p-value was from the log-rank test stratified by region.|Log Rank|Participants without consolidation/salvage therapy dates were censored using the earlier of the Early Termination and Study Completion dates.||||||0.69
70893634|NCT01259713|141273768|SUPERIORITY_OR_OTHER||Relative risk reduction|0.08||||0.2|TWO_SIDED|95.0|-0.04|0.19||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel||Relative risk reduction = 1 - risk ratio.|Participants were not stratified for leukemia risk.||0.19|-0.04|0.20
70893635|NCT06111742|141273801|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Induction||||<0.001
70893636|NCT06111742|141273801|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||OR entry||||<0.001
70893637|NCT06111742|141273802|SUPERIORITY|||||||0.022|||||||t-test, 2 sided|||||||0.022
70893638|NCT06111742|141273804|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||||||0.046
70893639|NCT01715805|141273854|SUPERIORITY||Least Squares Mean Difference (LSMD)|-0.2||||0.7948|TWO_SIDED|95.0|-1.6|1.2||MMRM with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses.|Mixed Models Analysis||Cariprazine + ADT - Placebo + ADT|||1.2|-1.6|0.7948
70893640|NCT01715805|141273855|SUPERIORITY||LSMD|-0.7||||0.2784|TWO_SIDED|95.0|-1.9|0.5||MMRM with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses.|Mixed Models Analysis||Cariprazine +ADT - Placebo + ADT|||0.5|-1.9|0.2784
70893641|NCT01306162|141273888|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtB: TrtA (%)|214.0|STANDARD_DEVIATION|19.9||1|TWO_SIDED|90.0|191.0|240.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation.|150mg DE + 400mg DR same time (TrtB) vs 150mg DE (TrtA)||240|191|1.0000
70893642|NCT01306162|141273888|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtC: TrtA (%)|130.0|STANDARD_DEVIATION|25.0||0.6697|TWO_SIDED|90.0|112.0|151.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR 2h later (TrtC) vs 150mg DE (TrtA)||151|112|0.6697
70893643|NCT01306162|141273888|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtD: TrtA (%)|236.0|STANDARD_DEVIATION|21.8||0.9992||90.0|173.0|321.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid same time (TrtD) vs 150mg DE (TrtA)||321|173|0.9992
70893644|NCT01306162|141273888|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtE: TrtA (%)|162.0|STANDARD_DEVIATION|20.1||0.9171|TWO_SIDED|90.0|119.0|221.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid 2h later (TrtE) vs 150mg DE (TrtA)||221|119|0.9171
70893645|NCT01306162|141273889|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtB: TrtA (%)|187.0|STANDARD_DEVIATION|24.3||0.9999|TWO_SIDED|90.0|162.0|215.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR (TrtB) vs 150mg DE (TrtA)||215|162|0.9999
70893646|NCT01306162|141273889|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtC: TrtA (%)|115.0|STANDARD_DEVIATION|31.2||0.2207|TWO_SIDED|90.0|95.0|138.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR 2h later (TrtC) vs 150mg DE (TrtA)||138|95|0.2207
70893647|NCT01306162|141273889|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtD: TrtA (%)|225.0|STANDARD_DEVIATION|26.1||0.9946||90.0|156.0|326.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid same time (TrtD) vs 150mg DE (TrtA)||326|156|0.9946
70893648|NCT01306162|141273889|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtE: TrtA (%)|133.0|STANDARD_DEVIATION|23.0||0.6221|TWO_SIDED|90.0|94.0|190.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid 2h later (TrtE) vs 150mg DE (TrtA)||190|94|0.6221
70893649|NCT01306162|141273890|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtB: TrtA (%)|214.0|STANDARD_DEVIATION|20.7||1|TWO_SIDED|90.0|190.0|241.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR (TrtB) vs 150mg DE (TrtA)||241|190|1.0000
70893650|NCT01306162|141273890|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtC: TrtA (%)|132.0|STANDARD_DEVIATION|26.3||0.7223|TWO_SIDED|90.0|113.0|155.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR 2h later (TrtC) vs 150mg DE (TrtA)||155|113|0.7223
70963624|NCT04427501|141432109|SUPERIORITY||Odds Ratio (OR)|1.48||||0.119|TWO_SIDED|95.0|0.9|2.43|||Regression, Logistic|||||2.43|0.90|0.119
70893651|NCT01306162|141273890|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtD: TrtA (%)|258.0|STANDARD_DEVIATION|24.6||0.9993||90.0|182.0|365.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid same time (TrtD) vs 150mg DE (TrtA)||365|182|0.9993
70893652|NCT01306162|141273890|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtE: TrtA (%)|159.0|STANDARD_DEVIATION|21.5||0.8875|TWO_SIDED|90.0|114.0|222.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid 2h later (TrtE) vs 150mg DE (TrtA)||222|114|0.8875
70893653|NCT01306162|141273891|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtB: TrtA (%)|180.0|STANDARD_DEVIATION|24.6||0.9998|TWO_SIDED|90.0|156.0|207.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR (TrtB) vs 150mg DE (TrtA)||207|156|0.9998
70893654|NCT01306162|141273891|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtC: TrtA (%)|114.0|STANDARD_DEVIATION|29.4||0.1866|TWO_SIDED|90.0|95.0|136.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR 2h later (TrtC) vs 150mg DE (TrtA)||136|95|0.1866
70893655|NCT01306162|141273891|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtD: TrtA (%)|234.0|STANDARD_DEVIATION|26.7||0.9958||90.0|160.0|340.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid same time (TrtD) vs 150mg DE (TrtA)||340|160|0.9958
70893656|NCT01306162|141273891|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtE: TrtA (%)|126.0|STANDARD_DEVIATION|22.6||0.5164|TWO_SIDED|90.0|89.0|179.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid 2h later (TrtE) vs 150mg DE (TrtA)||179|89|0.5164
70893657|NCT01949480|141273947|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.643|||||||t-test, 2 sided|||||||0.643
70893658|NCT01949480|141273949|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.077|||||||t-test, 2 sided|||This p-value is calculated for the NRS at rest.||||.077
70893659|NCT01949480|141273949|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.39|||||||t-test, 2 sided|||This p-value is calculated for the NRS during deep inspiration at 24 hrs.||||0.39
70893660|NCT01949480|141273950|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.605|||||||t-test, 2 sided|||||||0.605
70893661|NCT01949480|141273951|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.104|||||||t-test, 2 sided|||This p-value is for the Local Anesthetic infused in 24 hrs.||||0.104
70893662|NCT01949480|141273952|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.308|||||||t-test, 2 sided|||||||0.308
70893663|NCT01949480|141273953|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.487|||||||t-test, 2 sided|||||||0.487
70893664|NCT01949480|141273954|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.493|||||||t-test, 2 sided|||||||0.493
70893665|NCT01949480|141273955|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.574|||||||t-test, 2 sided|||||||0.574
70893666|NCT01949480|141273956|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.913|||||||t-test, 2 sided|||||||0.913
70893667|NCT01949480|141273957|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.783|||||||t-test, 2 sided|||||||0.783
70893668|NCT02890381|141273960|OTHER||% vaccine recipients with solicited AEs|64.0|||||TWO_SIDED|90.0|35.0|86.0||||||||86|35|
70893669|NCT02890381|141273960|OTHER||% placebo recipients with solicited AEs|100.0|||||TWO_SIDED|90.0|61.0|100.0||||||||100|61|
70893670|NCT02890381|141273961|OTHER||% vaccinees with unsolicited AEs|36.0|||||TWO_SIDED|90.0|14.0|65.0||||||||65|14|
70893671|NCT02890381|141273961|OTHER||% placebo with unsolicited AEs|50.0|||||TWO_SIDED|90.0|15.0|85.0||||||||85|15|
70893672|NCT02890381|141273966|SUPERIORITY|||||||0.64||||||Since the sample sizes are unequal, at the suggestion of the DSMB statistician, a 1-sided Fisher's exact test was used to test the hypothesis that the proportions of \>=4-fold rises were higher in the vaccinated group than in the placebo group.|Fisher Exact|||||||0.64
70893673|NCT02890381|141273967|SUPERIORITY|||||||0.73||||||The threshold for statistical significance is 0.05.|Log Rank|||||||0.73
70893674|NCT03825380|141274019|NON_INFERIORITY|"Primary tested:Non-inferiority of T4032 to Lumigan® on the change from baseline in IOP using a MMRM. 3 independent models will be performed, one for each time point (8:00, 10:00~\& 16:00). The 95% CI for treatment effect (difference T4032 - Lumigan) will be estimated at Wk 12. NI will be achieved if the upper bound of the 95% CI for the difference between treatment groups (T4032 - Lumigan) is lower than the margin of +1.5 mmHg for each of the 3 time points 8:00, 10:00 \& 16:00."|Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.23||0.453|TWO_SIDED|95.0|-0.62|0.28|||Mixed Models Analysis|||||0.28|-0.62|0.453
70893675|NCT02232893|141274020|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
70893676|NCT01358526|141274021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.163||0.0055|TWO_SIDED|95.0|0.13|0.77||A gate-keeping strategy and a Bonferroni-Holm method was used to control the family-wise (primary and secondary efficacy analysis) error rate at the 5% level.|Mixed Models Analysis|Mixed-model repeated measures analysis of pain data using a pattern mixture model framework||||0.77|0.13|0.0055
70893677|NCT01358526|141274022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3|STANDARD_ERROR_OF_MEAN|2.26||0.0191|TWO_SIDED|95.0|0.9|9.8|||Mixed Models Analysis|Mixed-model repeated measures analysis|Mean difference (final values) is the treatment comparison estimated using mixed model repeated measures analysis with effect for treatment, time (weeks 4, 8, 12), treatment by time interaction, and prerandomization value. Subject is a random effect.|||9.8|0.9|0.0191
70893678|NCT01358526|141274023|SUPERIORITY_OR_OTHER|||||||0.0002||||||"The proportion of subjects responding much improved and very much improved was summarized by treatment group and compared between groups using an exact test"|Fisher Exact|||||||0.0002
70893679|NCT01358526|141274024|SUPERIORITY_OR_OTHER|||||||0.0006|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test: responder as dependent variable, treatment as explanatory variable, dose at time of randomization as stratifying factor||Proportion of subjects with a response to treatment that is ≥ 30%||||0.0006
70893680|NCT01358526|141274025|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test: responder as dependent variable, treatment as explanatory variable, dose at time of randomization as stratifying factor||Proportion of subjects with a response to treatment that is ≥ 50%||||0.0018
70893681|NCT00156065|141274040|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Loss of Effect|0.8619||||||95.0|0.6912|0.9644|||||Loss of effect = increase in total PANSS \>=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score \>=6; discontinuation for lack of efficacy.|||0.9644|0.6912|
70893682|NCT00156065|141274040|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Loss of Effect|0.8834||||||95.0|0.7744|0.955|||||Loss of effect = increase in total PANSS \>=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score \>=6; discontinuation for lack of efficacy.|||0.9550|0.7744|
70893683|NCT00156065|141274040|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Loss of Effect|0.9376||||||95.0|0.7631|0.9952|||||Loss of effect = increase in total PANSS \>=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score \>=6; discontinuation for lack of efficacy.|||0.9952|0.7631|
70893684|NCT04745169|141274042|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
70893685|NCT04745169|141274043|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
70893686|NCT04745169|141274044|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
70893687|NCT04745169|141274045|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
70893688|NCT04745169|141274046|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
70893689|NCT04745169|141274047|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
70893690|NCT04745169|141274048|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
70893691|NCT04745169|141274049|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
70893692|NCT04745169|141274050|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
70893693|NCT01292603|141274052|NON_INFERIORITY_OR_EQUIVALENCE|A standard non-inferiority margin of 0.8 for the ratio of Ctrough was used. The non-inferiority limit corresponds to a maximal 20 percent (%) loss in Ctrough which is considered acceptable given the high variability and range of Ctrough data, with an 80% power and a one-sided alpha of 0.05.|Adjusted geometric mean ratio|1.533|||||TWO_SIDED|90.0|1.269|1.852|||||Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.|||1.852|1.269|
70893694|NCT01292603|141274053|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.102|||||TWO_SIDED|90.0|0.979|1.242|||||Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.|||1.242|0.979|
70893695|NCT01292603|141274054|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.719|||||TWO_SIDED|90.0|0.653|0.792|||||Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.|||0.792|0.653|
70893696|NCT01292603|141274055|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|14.884|||||TWO_SIDED|90.0|11.215|19.755|||||Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.|||19.755|11.215|
70893697|NCT01292603|141274056|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.01|||||TWO_SIDED|90.0|0.895|1.139|||||Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.|||1.139|0.895|
70893698|NCT01808690|141274066|SUPERIORITY|||||||0.005||||||Threshold for statistical significance P=0.05|Regression, Linear|We also fitted multivariable models, which included sex, pubertal status, change in BMI, and baseline M/I.||Insulin function was defined as M/I (mg/kg/min)/(insulin). Power calculations were based on data from a small study in youth with poorly controlled T1DM, which reported a significant increase in M/I in the 11 participants treated with Metformin. On the basis of the effect size reported in that study, a sample size of 25 per group and an alpha of 0.05 provided us with 93% power to detect a difference of 1 SD in the primary outcome of M/I.||||0.005
70893699|NCT01808690|141274067|SUPERIORITY|||||||0.46||||||Threshold for statistical significance P=0.05|Regression, Linear|Adjusted for the baseline value of the variable, sex, age, change in VO2peak, change in insulin sensitivity, and treatment condition.||||||0.46
70893700|NCT01808690|141274068|SUPERIORITY|||||||0.04||||||Threshold for statistical significance P=0.05|Regression, Linear|We also fitted mutlivariable models, which included changed in SBP, change in BMI, and change in M/I.||||||0.04
70893701|NCT01808690|141274069|SUPERIORITY|||||||0.04||||||Threshold for significance P=0.05|Regression, Linear|We also fitted mutlivariable models, which included changed in systolic blood pressure, change in BMI, and change in M/I.||||||0.04
70893702|NCT01808690|141274070|SUPERIORITY|||||||0.01||||||Threshold for statistical significance P=0.05|Regression, Linear|Adjusted for the baseline value of BMI percentile, diabetes duration, and A1c.||||||0.01
70893703|NCT01808690|141274071|SUPERIORITY|||||||0.03||||||Threshold for statistical significance P=0.05|Regression, Linear|We also fitted mutlivariable models, which included changed in SBP, change in BMI, and change in M/I.||||||0.03
70893704|NCT01808690|141274072|SUPERIORITY|||||||0.8||||||Threshold for significance P=0.05|Regression, Linear|We also fitted mutlivariable models, which included changed in systolic blood pressure, change in BMI, and change in M/I.||||||0.8
70893705|NCT03586648|141274088|SUPERIORITY|Statistically superiority will be concluded if the lower limit of the confidence intervals of the Test lens is greater than 32 points.|Least-square Mean|39.3|STANDARD_ERROR_OF_MEAN|3.31|||TWO_SIDED|95.0|32.7|45.9|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||Data only from the first period will be used if period effect is significant.||45.9|32.7|
70893706|NCT03586648|141274089|NON_INFERIORITY|Statistically superiority will be concluded if the lower limit of the confidence intervals of the Test lens is greater than -5 points.|Least-square Mean Difference|-11.5|STANDARD_ERROR_OF_MEAN|4.14|||TWO_SIDED|95.0|-19.7|-3.3|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test minus Control.|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.||-3.3|-19.7|
70893707|NCT02041195|141274091|OTHER||Least Squares (LS) Mean Difference|-4.26||||0.004|TWO_SIDED|90.0|-6.81|-1.72||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, timepoint, treatment-by-timepoint, baseline weight as covariate, and participant as random effect was used.|||-1.72|-6.81|0.004
70893708|NCT02041195|141274091|OTHER||LS Mean difference|-3.63||||0.012|TWO_SIDED|90.0|-6.23|-1.03|||Longitudinal mixed analysis of variance|One-sided p-value.|A longitudinal mixed analysis of variance model with fixed effects for treatment, timepoint, treatment-by-timepoint, baseline weight as covariate, and participant as random effect was used.|||-1.03|-6.23|0.012
70893709|NCT02041195|141274093|OTHER||LS Mean Difference|-3.57|||<|0.001|TWO_SIDED|90.0|-5.24|-1.89||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, timepoint, treatment-by-timepoint, baseline weight as covariate, and participant as random effect was used.|||-1.89|-5.24|<0.001
70893710|NCT02041195|141274095|OTHER||LS Mean Difference|-2.22||||0.002|TWO_SIDED|90.0|-3.44|-1.0|||Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, timepoint, treatment-by-timepoint, baseline weight as covariate, and participant as random effect was used.|||-1.00|-3.44|0.002
70893711|NCT02395120|141274105|SUPERIORITY||Odds Ratio (OR)|1.6|||<|0.05|TWO_SIDED|95.0|1.21|3.08||We addressed the issue of multiple testing, both multiple comparisons and multiple sites, using a gatekeeper approach. The use of 0.05 alpha level for each test maintained a 0.05 family-wise alpha level for the six tests (three at each site).|Regression, Logistic||||The primary outcome analysis utilized generalized estimating equations (GEE) with a logit link for the binary dental care receipt outcome. The GEE analysis was conducted using dental care receipt outcomes as restorative care alone (ICDAS codes ≥3), as well as combined preventive (i.e. sealants) and restorative care (ICDAS codes ≥1). Models were fit separately to the overall data (all sites combined), the combined EC and WA sites (based on our original plan of two predominantly low-income school districts), and the BD schools alone. Each model included, as covariates, indicator variables for intervention, site (except for the model with BD alone), child grade, and caregiver demographic variables (race, education, marital status). Corresponding estimated odds ratios and 95% Confidence Intervals were computed.|3.08|1.21|<0.05
70893712|NCT00674986|141274111|SUPERIORITY_OR_OTHER||Difference|0.28|STANDARD_ERROR_OF_MEAN|0.14||0.0416|TWO_SIDED|95.0|0.01|0.54|||Fisher Exact|||||0.54|0.01|0.0416
70893713|NCT00674986|141274112|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
70893714|NCT00674986|141274113|SUPERIORITY_OR_OTHER|||||||0.2777||95.0|||||t-test, 2 sided|||||||0.2777
70893715|NCT00674986|141274114|SUPERIORITY_OR_OTHER|||||||0.116||95.0|||||t-test, 2 sided|||||||0.1160
70893716|NCT00674986|141274115|SUPERIORITY_OR_OTHER|||||||0.1146||95.0|||||t-test, 2 sided|||||||0.1146
70893717|NCT00674986|141274116|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||t-test, 2 sided|||||||0.0470
70893718|NCT00674986|141274117|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||t-test, 2 sided|||||||0.0003
70893719|NCT00778648|141274135|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANOVA|||||||0.023
70893720|NCT03750552|141274140|SUPERIORITY||Least Squares Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.413||0.574|TWO_SIDED|95.0|-1.05|0.58|||Mixed Model Repeated Measures|||||0.58|-1.05|0.574
70893721|NCT03750552|141274141|SUPERIORITY||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.284||0.331|TWO_SIDED|95.0|-0.84|0.28|||Mixed Model Repeated Measures|||||0.28|-0.84|0.331
70893722|NCT03750552|141274142|SUPERIORITY||Least Squares Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.376||0.481|TWO_SIDED|95.0|-1.01|0.48|||Mixed Model Repeated Measures|||||0.48|-1.01|0.481
70893723|NCT03750552|141274143|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.073||0.74|TWO_SIDED|95.0|-0.12|0.17|||Cochran-Mantel-Haenszel|Stratified by disease type|The assumed common risk difference estimate and standard error are calculated using Mantel-Haenszel stratum weights and the Sato variance estimator. Mantel-Haenszel confidence limits are shown.|||0.17|-0.12|0.740
70893724|NCT03750552|141274144|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.064||0.0903|TWO_SIDED|95.0|-0.02|0.24|||Cochran-Mantel-Haenszel|Stratified by disease type|The assumed common risk difference estimate and standard error are calculated using Mantel-Haenszel stratum weights and the Sato variance estimator. Mantel-Haenszel confidence limits are shown.|||0.24|-0.02|0.0903
70893725|NCT00626522|141274145|SUPERIORITY_OR_OTHER||Least squares mean difference|0.206|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.131|0.28|||ANCOVA|||||0.280|0.131|<0.0001
70893726|NCT00626522|141274145|SUPERIORITY_OR_OTHER||Least squares mean difference|0.254|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.18|0.329|||ANCOVA|||||0.329|0.180|<0.0001
70893727|NCT00626522|141274145|SUPERIORITY_OR_OTHER||Least squares mean difference|0.265|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.191|0.34|||ANCOVA|||||0.340|0.191|<0.0001
70893728|NCT03822533|141274179|SUPERIORITY||Mean Difference (Final Values)|0.015||||0.69|TWO_SIDED|95.0|-0.059|0.089|||t-test, 2 sided|||Mean difference using independent samples t-test.||0.089|-0.059|0.69
70893729|NCT03822533|141274179|SUPERIORITY||Mean Difference (Final Values)|-0.015|||||TWO_SIDED|95.0|-0.093|0.063||The linear regression analysis was needed to calculate the incremental cost efficiency ratio (ICER). The p-value from this test was not relevant for the ICER calculation.|Regression, Linear|First step in a cost-efficiency analysis||Presenting β-values from linear regression analysis for group variable adjusted for baseline differences in EQ-5D-3L-index. The results from this analysis were used to calculate incremental cost-effectiveness ratio (mean difference in costs divided by mean difference in QALYs).||0.063|-0.093|
70893730|NCT03822533|141274180|SUPERIORITY||Mean Difference (Final Values)|-364.0||||0.17|TWO_SIDED|95.0|-891.0|164.0|||t-test, 2 sided|||Independent-samples t-test. Dependent variable cost items, independent variable group (physiotherapist or physician assessment)||164|-891|0.17
70893731|NCT03822533|141274180|SUPERIORITY||Mean Difference (Final Values)|-364.0|||||TWO_SIDED|95.0|-870.0|143.0||The linear regression analysis was needed to calculate the incremental cost efficiency ratio (ICER). The p-value from this test was not relevant for the ICER calculation.|Regression, Linear|First step in a cost-efficiency analysis||||143|-870|
70893732|NCT03822533|141274181|SUPERIORITY||Mean Difference (Final Values)|-233.0||||0.23|TWO_SIDED|95.0|-616.0|150.0|||t-test, 2 sided|||Independent-samples t-test. Dependent variable cost items, independent variable group (physiotherapist or physician assessment)||150|-616|0.23
70893733|NCT03822533|141274181|SUPERIORITY||Mean Difference (Final Values)|-233.0|||||TWO_SIDED|95.0|-605.0|139.0||The linear regression analysis was needed to calculate the incremental cost efficiency ratio (ICER). The p-value from this test was not relevant for the ICER calculation.|Regression, Linear|First step in a cost-efficiency analysis.||Linear regression analysis. The results from this analysis were used to calculate incremental cost-effectiveness ratio (mean difference in costs divided by mean difference in QALYs).||139|-605|
70893734|NCT03822533|141274184|SUPERIORITY||Mean Difference (Final Values)|48.0||||0.72|TWO_SIDED|95.0|-219.0|314.0|||t-test, 2 sided|||||314|-219|0.72
70893735|NCT03822533|141274185|SUPERIORITY||Mean Difference (Final Values)|-178.0|||<|0.01|TWO_SIDED|95.0|-239.0|118.0|||t-test, 2 sided|||||118|-239|<0.01
70893736|NCT03822533|141274186|SUPERIORITY||Mean Difference (Final Values)|-24.0||||0.01|TWO_SIDED|95.0|-42.0|6.2|||t-test, 2 sided|||||6.2|-42|0.01
70893737|NCT03822533|141274187|SUPERIORITY||Mean Difference (Final Values)|-12.0||||0.62|TWO_SIDED|95.0|-59.0|36.0|||t-test, 2 sided|||||36|-59|0.62
70893738|NCT03822533|141274188|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.87|TWO_SIDED|95.0|-13.0|15.0|||t-test, 2 sided|||||15|-13|0.87
70893739|NCT03822533|141274189|SUPERIORITY||Mean Difference (Final Values)|-254.0||||0.27|TWO_SIDED|95.0|-728.0|220.0|||t-test, 2 sided|||||220|-728|0.27
70893740|NCT03822533|141274190|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.96|TWO_SIDED|95.0|-113.0|118.0|||t-test, 2 sided|||||118|-113|0.96
70893741|NCT02349295|141274193|OTHER||Odds Ratio (OR)|4.74|||<|0.001|TWO_SIDED|95.0|2.65|8.48||model includes: treatment, geographic region, and tumor necrosis factor inhibitor (TNFi) experience (inadequate responder to 1 TNFi, inadequate responder to 2 TNFi, or intolerance to a TNFi).|Regression, Logistic|1\) uses a Wald's test , 2) Non-responder imputation (NRI) was used to calculate the response rates.||||8.48|2.65|<0.001
70893742|NCT02349295|141274193|OTHER|1\) uses a Wald's test , 2) Non-responder imputation (NRI) was used to calculate the response rates.|Odds Ratio (OR)|3.79|||<|0.001|TWO_SIDED|95.0|2.12|6.78|||Regression, Logistic|||model includes: treatment, geographic region, and TNFi experience (inadequate responder to 1 TNFi, inadequate responder to 2 TNFi, or intolerance to a TNFi)||6.78|2.12|<0.001
70893743|NCT00958919|141274242|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0||||0.0004|TWO_SIDED|95.0|2.69|9.38|||t-test, 2 sided|||||9.38|2.69|.0004
70893744|NCT00958919|141274243|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.0||||0.024|TWO_SIDED|95.0|0.49|6.85|||t-test, 2 sided|||||6.85|0.49|.024
70893745|NCT00958919|141274244|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||t-test, 2 sided|||||||0.45
70893746|NCT00958919|141274245|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
70893747|NCT00958919|141274246|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
70893748|NCT01552213|141274247|SUPERIORITY||Risk Ratio (RR)|0.8||||0.32|TWO_SIDED|95.0|0.53|1.24|||Chi-squared|||||1.24|0.53|0.32
70893749|NCT01552213|141274248|SUPERIORITY|||||||0.32|||||||Chi-squared|||||||0.32
70893750|NCT01552213|141274249|SUPERIORITY|||||||0.96|||||||Chi-squared|||||||0.96
70893751|NCT01552213|141274250|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
70893752|NCT01552213|141274251|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||||||0.75
70893753|NCT01552213|141274252|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
70893754|NCT01552213|141274253|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.5
70893755|NCT01552213|141274254|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.6
70893756|NCT01552213|141274255|SUPERIORITY|||||||0.36|||||||Chi-squared|||||||0.36
70893757|NCT01552213|141274256|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||||||0.42
70893758|NCT01552213|141274257|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.5
70893759|NCT01552213|141274258|SUPERIORITY|||||||0.46|||||||Chi-squared|||||||0.46
70893760|NCT01552213|141274259|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
70893761|NCT01552213|141274260|SUPERIORITY|||||||0.56|||||||Chi-squared|||||||0.56
70893762|NCT04723576|141274266|OTHER|Standard 2-sided non-equivalence test|Mean Difference (Net)|0.189||||0.77|TWO_SIDED|95.0|-1.068|1.446|||Mixed Models Analysis||Effect sizes are the difference between SFA minus Usual Care.|||1.446|-1.068|.77
70893763|NCT04723576|141274267|OTHER|Standard 2-sided non-equivalence test|Median Difference (Net)|0.238||||0.39|TWO_SIDED|95.0|-0.31|0.785|||Mixed Models Analysis||Effect sizes are the difference between SFA minus Usual Care.|||0.785|-0.310|.39
70893764|NCT04723576|141274268|OTHER|Standard 2-sided non-equivalence test|Mean Difference (Net)|-0.232||||0.24|TWO_SIDED|95.0|-0.618|0.153|||Mixed Models Analysis||Effect sizes are the difference between SFA minus Usual Care.|||0.153|-0.618|.24
70893765|NCT04723576|141274269|OTHER|Standard 2-sided non-equivalence test|Median Difference (Net)|0.134||||0.23|TWO_SIDED|95.0|-0.085|0.352|||Mixed Models Analysis||Effect sizes are the difference between SFA minus Usual Care.|||0.352|-0.085|.23
70893766|NCT04723576|141274270|OTHER|Standard 2-sided non-equivalence test|Median Difference (Net)|-0.051||||0.44|TWO_SIDED|95.0|-0.179|0.078|||Mixed Models Analysis||Effect sizes are the difference between SFA minus Usual Care.|||0.078|-0.179|.44
70893767|NCT04723576|141274271|OTHER|Standard 2-sided non-equivalence test|Odds Ratio, log|-0.051||||0.85|TWO_SIDED|95.0|-0.179|0.078|||Repeated measure logistic regression|using GEE method|Effect sizes are the difference between SFA minus Usual Care.|||0.078|-0.179|.85
70893768|NCT04723576|141274272|OTHER|Standard 2-sided non-equivalence test|Median Difference (Net)|0.23||||0.08|TWO_SIDED|95.0|-0.025|0.484|||Mixed Models Analysis||Effect sizes are the difference between SFA minus Usual Care|||0.484|-0.025|.08
70963625|NCT04427501|141432112|SUPERIORITY||Odds Ratio (OR)|0.23||||0.098|TWO_SIDED|95.0|0.04|1.31|||Regression, Logistic|||||1.31|0.04|0.098
70893769|NCT01362140|141274336|SUPERIORITY_OR_OTHER|||||||0.008|||||||Chi-squared|||"The primary hypothesis to be tested was that the percentage of participants with at least~1 RBC transfusion from week 5 to the EOTP was lower in the darbepoetin alfa group than in the placebo group. This hypothesis was confirmed if the incidence of RBC transfusion in the darbepoetin alfa group was lower and had a p-value \< 0.05 from a 2-sided Chi-square test."||||0.008
70893770|NCT01362140|141274337|SUPERIORITY_OR_OTHER|||||||0.017|||||||Cochran-Mantel-Haenszel|The overall 2-sided CMH test with IPSS score as stratification factor.||If the primary hypothesis was confirmed, the secondary hypothesis to be tested was that the percentage of participants achieving an IWG erythroid response during the 24-week double-blind treatment period was greater in the darbepoetin alfa group than in the placebo group. This hypothesis was confirmed if erythroid response was higher in the darbepoetin alfa group and the p-value was \< 0.05 from a 2-sided Cochran-Mantel-Haenszel test using the IPSS as a stratification factor.||||0.017
70893771|NCT01201629|141274349|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
70893772|NCT01201629|141274350|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70893773|NCT00395876|141274418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.6||||0.0002||95.0|18.4|54.8||Stratified by baseline weight (\< 30 kg, ≥ 30 kg)|Cochran-Mantel-Haenszel|||||54.8|18.4|0.0002
70893774|NCT00395876|141274419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.4||||0.1385||95.0|-3.1|25.8||Stratified by baseline weight (\< 30 kg, ≥ 30 kg)|Cochran-Mantel-Haenszel|||||25.8|-3.1|0.1385
70893775|NCT00395876|141274420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.9||||0.0093||95.0|7.1|42.6||Stratified by baseline weight (\< 30 kg, ≥ 30 kg)|Cochran-Mantel-Haenszel|||||42.6|7.1|0.0093
70893776|NCT01934218|141274454|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.988|TWO_SIDED|95.0|-2.7|2.7|||Basic longitudinal model|||||2.7|-2.7|0.988
70893777|NCT01934218|141274455|OTHER|Euflexxa would be considered superior to Gel-One if the difference in mean change from baseline in VAS pain score at week 26 was 5 mm or greater (on the 100mm VAS pain scale). If the difference in mean change values were within 5 mm, Gel-One would not be considered inferior to Euflexxa.||||||||||||||||A post-hoc non-inferiority comparison of the Gel-One mean change from baseline in VAS pain score at week 26 (Following 50-foot walk test) against the same assessment collected from subjects treated with Euflexxa in a separate study (PMID:19539353) was also performed.|Change from baseline (95% CI) for Euflexxa was -25.7 (-29.0, -22.4) and the difference between Euflexxa and Gel-One (95% CI) was -3.8 (-inf, -0.3).|||
70893778|NCT01359735|141274517|SUPERIORITY_OR_OTHER|||||||0.263|TWO_SIDED|||||Week 04|Wilcoxon (Mann-Whitney)|||||||0.263
70893779|NCT01359735|141274517|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|||||Week 13|Wilcoxon (Mann-Whitney)|||||||0.500
70893780|NCT01359735|141274518|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|||||Over weeks 1 through 4 or Week 4?|Fisher Exact|||||||0.5
70893781|NCT01359735|141274519|SUPERIORITY_OR_OTHER|||||||0.0594|TWO_SIDED||||||Log Rank|||||||0.0594
70893782|NCT01359735|141274520|SUPERIORITY_OR_OTHER|||||||0.1354|ONE_SIDED|||||3 Weeks|t-test, 1 sided|||||||0.1354
70893783|NCT01359735|141274520|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|||||12 Weeks|t-test, 1 sided|||||||0.5000
70893784|NCT01359735|141274521|SUPERIORITY_OR_OTHER|||||||0.0841|TWO_SIDED|||||Week 3 Post-surgery|t-test, 1 sided|||||||0.0841
70893785|NCT01359735|141274521|SUPERIORITY_OR_OTHER|||||||0.178|TWO_SIDED|||||Week 12 Post-surgery|t-test, 1 sided|||||||0.1780
70893786|NCT03387852|141274545|SUPERIORITY||Odds ratio|0.423|||=|0.0214|TWO_SIDED|95.0|0.203|0.88|||Regression, Logistic||SAR440340 300 mg vs. Placebo|Odds ratio, 95% confidence interval (CI), and p-value derived from logistic regression with treatment, baseline eosinophil strata, region, background ICS dose level at randomization and number of exacerbation events (defined as required use of systemic \[oral and/or parenteral\] steroid treatment, or required hospitalization or emergency room visit) within 1 year prior to screening.||0.88|0.203|=0.0214
70893787|NCT03387852|141274545|SUPERIORITY||Odds ratio|0.52|||=|0.0709|TWO_SIDED|95.0|0.256|1.057|||Regression, Logistic||SAR440340 + Dupilumab vs. Placebo|Odds ratio, 95% CI, and p-value derived from logistic regression with treatment, baseline eosinophil strata, region, background ICS dose level at randomization and number of exacerbation events (defined as required use of systemic \[oral and/or parenteral\] steroid treatment, or required hospitalization or emergency room visit) within 1 year prior to screening.||1.057|0.256|=0.0709
70893788|NCT02194621|141274559|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||>0.05
70893789|NCT02194621|141274560|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
70893790|NCT02194621|141274561|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||>0.05
70893791|NCT02194621|141274562|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.002
70893792|NCT02010060|141274633|SUPERIORITY|||||||0.074|||||||ANCOVA|||||||0.074
70893793|NCT02010060|141274633|SUPERIORITY|||||||0.684|||||||ANCOVA|||Change in waist circumference between AERO and CON||||0.684
70893794|NCT02010060|141274633|SUPERIORITY|||||||0.18|||||||ANCOVA|||Comparison between the AERO group and the AERO-PA group||||0.180
70893795|NCT02010060|141274634|SUPERIORITY|||||||0.011|||||||ANCOVA|||Change in body fat between the AERO-PA group and the CON group||||0.011
70893796|NCT02010060|141274634|SUPERIORITY|||||||0.16|||||||ANCOVA|||||||0.16
70893797|NCT02010060|141274634|SUPERIORITY|||||||0.258|||||||ANCOVA|||Change in body fat between the AERO and AERO-PA group||||0.258
70893798|NCT02010060|141274635|SUPERIORITY|||||||0.104|||||||ANCOVA|||Comparison of body weight between the CON and AERO-PA groups||||0.104
70893799|NCT02010060|141274635|SUPERIORITY|||||||0.578|||||||ANCOVA|||Change in body weight between the CON and AERO groups||||0.578
70893800|NCT02010060|141274635|SUPERIORITY|||||||0.3|||||||ANCOVA|||Change in body weight between the AERO and AERO-PA groups||||0.300
70893801|NCT02010060|141274636|SUPERIORITY|||||||0.002|||||||ANCOVA|||Change in cardiorespiratory fitness (L/min) between the AERO and AERO-PA groups||||0.002
70893802|NCT02010060|141274636|SUPERIORITY|||||||0.314|||||||ANCOVA|||Change in cardiorespiratory fitness (L/min) AERO and CON groups||||0.314
70893803|NCT02010060|141274636|SUPERIORITY|||||||0.041|||||||ANCOVA|||Change in cardiorespiratory fitness (L/min) between the AERO and AERO-PA groups||||0.041
70893804|NCT02010060|141274637|SUPERIORITY|||||||0.891|||||||ANCOVA|||Change in insulin sensitivity between the CON and AERO-PA groups||||0.891
70893805|NCT02010060|141274637|SUPERIORITY|||||||0.417|||||||ANCOVA|||Change in insulin sensitivity between the CON and AERO groups||||0.417
70893806|NCT02010060|141274637|SUPERIORITY|||||||0.484|||||||ANCOVA|||Change in insulin sensitivity between the AERO and AERO-PA groups||||0.484
70893807|NCT02010060|141274638|SUPERIORITY|||||||0.274|||||||ANCOVA|||Change in Low density lipoprotein (LDL) between the CON and the AERO groups||||0.274
70893808|NCT02010060|141274638|SUPERIORITY|||||||0.461|||||||ANCOVA|||Change in Low density lipoprotein (LDL) between the CON and AERO groups||||0.461
70893809|NCT02010060|141274638|SUPERIORITY|||||||0.739|||||||ANCOVA|||Change in Low density lipoprotein (LDL) between AERO and AERO-PA groups||||0.739
70893810|NCT02010060|141274639|SUPERIORITY|||||||0.837|||||||ANCOVA|||Change in high density lipoprotein (HDL) between the CON and AERO-PA group||||0.837
70893811|NCT02010060|141274639|SUPERIORITY|||||||0.895|||||||ANCOVA|||Change in high density lipoprotein (HDL) between the CON and AERO groups||||0.895
70893812|NCT02010060|141274639|SUPERIORITY|||||||0.744|||||||ANCOVA|||||||0.744
70893813|NCT02010060|141274640|SUPERIORITY|||||||0.067|||||||ANCOVA|||Change in total cholesterol (mg/dL)||||0.067
70893814|NCT02010060|141274640|SUPERIORITY|||||||0.254|||||||ANCOVA|||Change in total cholesterol (mg/dL) between the CON and AERO groups||||0.254
70893815|NCT02010060|141274640|SUPERIORITY|||||||0.501|||||||ANCOVA|||Change in total cholesterol (mg/dL) between AERO and AERO-PA groups||||0.501
70893816|NCT02010060|141274641|SUPERIORITY|||||||0.456|||||||ANCOVA|||Change in triglyceride level between the AERO-PA and CON groups||||0.456
70893817|NCT02010060|141274641|SUPERIORITY|||||||0.422|||||||ANCOVA|||Change in triglyceride level between the CON and AERO groups||||0.422
70893818|NCT02010060|141274641|SUPERIORITY|||||||0.136|||||||ANCOVA|||Change in triglyceride level between the AERO and AERO-PA groups||||0.136
70893819|NCT02010060|141274642|SUPERIORITY|||||||0.483|||||||ANCOVA|||Change in glucose level between the CON and AERO-PA groups||||0.483
70893820|NCT02010060|141274642|SUPERIORITY|||||||0.274|||||||ANCOVA|||Change in glucose between the CON and AERO groups||||0.274
70893821|NCT02010060|141274642|SUPERIORITY|||||||0.685|||||||ANCOVA|||Change in glucose level between the AERO and AERO-PA groups||||0.685
70893822|NCT02010060|141274643|SUPERIORITY|||||||0.489|||||||ANCOVA|||Change in systemic inflammation between CON and AERO-PA groups||||0.489
70893823|NCT02010060|141274643|SUPERIORITY|||||||0.652|||||||ANCOVA|||Change in systemic inflammation between the CON and AERO groups||||0.652
70893824|NCT02010060|141274643|SUPERIORITY|||||||0.822|||||||ANCOVA|||Change in systemic inflammation between the AERO and AERO-PA groups||||0.822
70893825|NCT02010060|141274644|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Changes in steps between the CON group and the AERO-PA group||||<0.001
70893826|NCT02010060|141274644|SUPERIORITY|||||||0.648|||||||ANCOVA|||Changes in steps between the CON and the AERO group||||0.648
70893827|NCT02010060|141274644|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Changes in steps between the AERO and AERO-PA groups||||<0.001
70893828|NCT02010060|141274645|SUPERIORITY|||||||0.226|||||||ANCOVA|||Change in kilocalories (dietary intake) between CON and AERO-PA group||||0.226
70893829|NCT02010060|141274645|SUPERIORITY|||||||0.215|||||||ANCOVA|||Change in caloric intake between the CON and the AERO groups||||0.215
70893830|NCT02010060|141274645|SUPERIORITY|||||||0.957|||||||ANCOVA|||Change in caloric intake (kilocalories) between the AERO and AERO-PA groups||||0.957
70893831|NCT02010060|141274646|SUPERIORITY|||||||0.337|||||||ANCOVA|||Change in insulin concentration between the CON and AERO-PA group||||0.337
70893832|NCT02010060|141274646|SUPERIORITY|||||||0.77|||||||ANCOVA|||Change in insulin level between the AERO and CON groups||||0.770
70893833|NCT02010060|141274646|SUPERIORITY|||||||0.515|||||||ANCOVA|||Change in insulin concentration between AERO and AERO-PA groups||||0.515
70893834|NCT00791765|141274749|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||van Elteren's test|Stratified by baseline body mass index group||||||<0.0001
70893835|NCT00791765|141274750|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by baseline body mass index group||||||<0.0001
70893836|NCT00791765|141274751|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||2-sided pairwise van Elteren's test|Stratified by baseline body mass index group||Comparison of week 24 outcome to week 12 outcome (see Outcome Measure 1)||||<0.0001
70893837|NCT00791765|141274752|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Two-sided test with modified ridit scores stratified by baseline body mass index group||||||<0.0001
70893838|NCT01461668|141274767|SUPERIORITY||Odds Ratio (OR)|0.41||||0.32|TWO_SIDED|95.0|0.08|1.86|||Fisher Exact||Confidence interval for the odds ratio is based upon the inversion Fisher's exact test|||1.86|0.08|0.320
70893839|NCT01024569|141274768|SUPERIORITY||MIXREG Estimate|-1.16|STANDARD_ERROR_OF_MEAN|-2.21||0.027|TWO_SIDED||||||Mixed Effects Random Regression|||||||0.027
70893840|NCT01024569|141274769|SUPERIORITY||MIXREG Estimate|0.4|STANDARD_ERROR_OF_MEAN|2.37||0.02|TWO_SIDED||||||Mixed Effects Random Regression|||Mixed Effects Random Regression analysis was used to assess the effects of study condition on Hope outcomes.||||0.020
70893841|NCT01024569|141274770|SUPERIORITY||MIXREG Estimate|0.05|STANDARD_ERROR_OF_MEAN|0.02||0.029|TWO_SIDED||||||Mixed Effects Random Regression|||||||0.029
70893842|NCT01024569|141274771|SUPERIORITY||MIXREG Estimate|1.06|STANDARD_ERROR_OF_MEAN|0.52||0.042|TWO_SIDED||||||Mixed Effects Random Regression|||||||0.042
70893843|NCT01024569|141274772|SUPERIORITY||MIXREG Estimate|0.39|STANDARD_ERROR_OF_MEAN|0.11||0.001|TWO_SIDED||||||Mixed Effects Random Regression|||||||.001
70893844|NCT00907153|141274773|SUPERIORITY||Mean Difference (Net)|-0.017||||0.05|TWO_SIDED|95.0|-0.034|0.0|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||-0.000|-0.034|0.05
70893845|NCT00907153|141274774|SUPERIORITY||Mean Difference (Net)|-1.14||||0.62|TWO_SIDED|95.0|-5.89|3.62|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||3.62|-5.89|0.62
70893846|NCT00907153|141274775|SUPERIORITY||Mean Difference (Net)|-3.65||||0.48|TWO_SIDED|95.0|-14.32|7.02|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||7.02|-14.32|0.48
70893847|NCT00907153|141274776|SUPERIORITY||Mean Difference (Net)|-6.51||||0.02|TWO_SIDED|95.0|-12.07|-0.96|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||-0.96|-12.07|0.02
70893848|NCT00907153|141274777|SUPERIORITY||Mean Difference (Net)|6.28||||0.22|TWO_SIDED|95.0|-3.97|16.54|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||16.54|-3.97|0.22
70893849|NCT00907153|141274778|SUPERIORITY||Mean Difference (Net)|13.84||||0.33|TWO_SIDED|95.0|-210.29|37.98|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||37.98|-210.29|0.33
70893850|NCT00907153|141274779|SUPERIORITY||Mean Difference (Net)|-12.8||||0.39|TWO_SIDED|95.0|-42.94|17.34|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||17.34|-42.94|0.39
70893851|NCT00907153|141274780|SUPERIORITY||Mean Difference (Net)|-75.08||||0.09|TWO_SIDED|95.0|-161.9|11.78|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||11.78|-161.9|0.09
70893852|NCT00907153|141274781|SUPERIORITY||Mean Difference (Net)|0.73||||0.96|TWO_SIDED|95.0|-32.59|34.06|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||34.06|-32.59|0.96
70893853|NCT00907153|141274782|SUPERIORITY||Mean Difference (Net)|3.08||||0.21|TWO_SIDED|95.0|-1.84|7.99|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||7.99|-1.84|0.21
70893854|NCT00907153|141274783|SUPERIORITY||Mean Difference (Net)|0.11||||0.99|TWO_SIDED|95.0|-24.43|24.64|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||24.64|-24.43|0.99
70893855|NCT00907153|141274784|SUPERIORITY||Median Difference (Net)|-1.93||||0.62|TWO_SIDED|95.0|-10.12|6.26|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||6.26|-10.12|0.62
70893856|NCT00907153|141274785|SUPERIORITY||Mean Difference (Net)|0.28||||0.98|TWO_SIDED|95.0|-20.29|20.85|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||20.85|-20.29|0.98
70893857|NCT00907153|141274786|SUPERIORITY||Mean Difference (Net)|10.24||||0.64|TWO_SIDED|95.0|-34.61|55.08|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||55.08|-34.61|0.64
70893858|NCT00907153|141274787|SUPERIORITY||Mean Difference (Net)|0.88||||0.88|TWO_SIDED|95.0|-22.81|8.51|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||8.51|-22.81|0.88
70893859|NCT00907153|141274788|SUPERIORITY||Mean Difference (Net)|-3.15||||0.25|TWO_SIDED|95.0|-8.7|2.41|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||2.41|-8.70|0.25
70893860|NCT00907153|141274789|SUPERIORITY||Mean Difference (Net)|44.31|||<|0.001|TWO_SIDED|95.0|27.13|61.48|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||61.48|27.13|<0.001
70893861|NCT00907153|141274790|SUPERIORITY||Mean Difference (Net)|1.56||||0.38|TWO_SIDED|95.0|-2.08|5.2|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||5.20|-2.08|0.38
70893862|NCT00907153|141274791|SUPERIORITY||Mean Difference (Net)|-7.84||||0.46|TWO_SIDED|95.0|-29.34|13.67|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||13.67|-29.34|0.46
70893863|NCT03147248|141274798|NON_INFERIORITY|The non-inferiority was to be concluded if the lower limit of the two-sided 95% confidence interval (CI) for the difference in the mean change from baseline of DAS28 (CRP) at Week 22 was greater that the pre-specified non-inferiority margin of -0.6.|Difference of Least square mean|0.27|||||TWO_SIDED|95.0|0.02|0.52|||||The least squares means and standard errors, estimate of treatment difference (CT-P13 SC 120 mg - CT-P13 IV 3 mg/kg), and 2-sided 95% CI obtained from the ANCOVA model.|Primary efficacy analysis were analyzed using an ANCOVA considering the treatment as fixed effect and country, serum CRP concentration at Week 2 (≤0.6 mg/dL vs. \>0.6 mg/dL), and body weight at Week 6 (≤100 kg vs. \>100 kg) as covariates.||0.52|0.02|
70893864|NCT02212028|141274810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|68.0||||0.022|TWO_SIDED|95.0|10.0|126.0|||ANOVA|||||126|10|0.022
70893865|NCT02212028|141274811|SUPERIORITY_OR_OTHER|||||||0.005|||||||ANOVA|||||||0.005
70893866|NCT00581230|141274814|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||Wilcoxon signed rank test|||||||0.0003
70893867|NCT00581230|141274815|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Wilcoxon signed rank test|||||||0.0001
70893868|NCT00321854|141274882|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.9||0.6503||95.0|-2.2|1.4|||ANCOVA|||||1.4|-2.2|0.6503
70893869|NCT00321854|141274883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.9||0.9568||95.0|-1.7|1.8|||ANCOVA|||||1.8|-1.7|0.9568
70893870|NCT00321854|141274884|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.8|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001||95.0|-6.3|-3.2|||ANCOVA|||||-3.2|-6.3|<0.0001
70893871|NCT00321854|141274885|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.4|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001||95.0|-5.8|-3.0|||ANCOVA|||||-3|-5.8|<0.0001
70893872|NCT00321854|141274886|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001||95.0|-4.1|-1.7|||ANCOVA|||||-1.7|-4.1|<0.0001
70893873|NCT00321854|141274887|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.9||0.8693||95.0|-1.8|1.5|||ANCOVA|||||1.5|-1.8|0.8693
70893874|NCT00321854|141274888|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.9||0.8155||95.0|-1.5|1.9|||ANCOVA|||||1.9|-1.5|0.8155
70893875|NCT00321854|141274889|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.5|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001||95.0|-6.0|-3.0|||ANCOVA|||||-3|-6|<0.0001
70893876|NCT00321854|141274890|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.0|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001||95.0|-5.4|-2.6|||ANCOVA|||||-2.6|-5.4|<0.0001
70893877|NCT00321854|141274891|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.8|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001||95.0|-3.9|-1.7|||ANCOVA|||||-1.7|-3.9|<0.0001
70893878|NCT00321854|141274892|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.7||0.7999||95.0|-1.5|1.1|||ANCOVA|||||1.1|-1.5|0.7999
70893879|NCT00321854|141274893|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.7||0.7395||95.0|-1.1|1.5|||ANCOVA|||||1.5|-1.1|0.7395
70893880|NCT00321854|141274894|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001||95.0|-4.5|-2.2|||ANCOVA|||||-2.2|-4.5|<0.0001
70893881|NCT00321854|141274895|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001||95.0|-4.0|-1.8|||ANCOVA|||||-1.8|-4|<0.0001
70893882|NCT00321854|141274896|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.5||0.0002||95.0|-2.7|-0.9|||ANCOVA|||||-0.9|-2.7|0.0002
70893883|NCT00321854|141274897|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9256||95.0|-0.6|0.6|||ANCOVA|||||0.6|-0.6|0.9256
70893884|NCT00321854|141274898|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9792||95.0|-0.6|0.6|||ANCOVA|||||0.6|-0.6|0.9792
70893885|NCT00321854|141274899|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|0.3||0.0001||95.0|-1.7|-0.5|||ANCOVA|||||-0.5|-1.7|0.0001
70893886|NCT00321854|141274900|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001||95.0|-1.6|-0.6|||ANCOVA|||||-0.6|-1.6|<0.0001
70893887|NCT00321854|141274901|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-1.5|-0.6|||ANCOVA|||||-0.6|-1.5|<0.0001
70893888|NCT00321854|141274902|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0376||95.0|-0.5|0.0|||ANCOVA|||||0|-0.5|0.0376
70893889|NCT00321854|141274903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1607||95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.1607
70893890|NCT00321854|141274904|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0173||95.0|-0.5|-0.1|||ANCOVA|||||-0.1|-0.5|0.0173
70893891|NCT00321854|141274905|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0007||95.0|-0.6|-0.2|||ANCOVA|||||-0.2|-0.6|0.0007
70893892|NCT00321854|141274906|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4381||95.0|-0.3|0.1|||ANCOVA|||||0.1|-0.3|0.4381
70893893|NCT00321854|141274907|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.796||||0.5116||95.0|0.403|1.573|||Regression, Logistic|||||1.573|0.403|0.5116
70893894|NCT00321854|141274908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.153||||0.7913||95.0|0.403|3.299|||Regression, Logistic|||The ordinal responses (3 levels) were analysed using the proportional odds model extension of logistic regression||3.299|0.403|0.7913
70893895|NCT00321854|141274909|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.1702||95.0|-1.3|0.2|||ANCOVA|||||0.2|-1.3|0.1702
70893896|NCT00321854|141274910|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|0.4||0.0009||95.0|-2.2|-0.6|||ANCOVA|||||-0.6|-2.2|0.0009
70893897|NCT00321854|141274911|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|0.4||0.0005||95.0|-2.1|-0.6|||ANCOVA|||||-0.6|-2.1|0.0005
70893898|NCT00321854|141274912|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0422||95.0|-1.4|0.0|||ANCOVA|||||0|-1.4|0.0422
70893899|NCT00321854|141274913|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.573||||0.2149||95.0|-1.823|0.677|||Wilcoxon (Mann-Whitney)|||||0.677|-1.823|0.2149
70893900|NCT00321854|141274914|SUPERIORITY_OR_OTHER||Median Difference (Net)|-2.031||||0.0001||95.0|-3.125|-0.938|||Wilcoxon (Mann-Whitney)|||||-0.938|-3.125|0.0001
70893901|NCT00321854|141274915|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.2605||95.0|0.0|0.026|||Wilcoxon (Mann-Whitney)|||||0.026|0|0.2605
70893902|NCT00321854|141274916|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.051|||<|0.0001||95.0|0.0|0.089|||Wilcoxon (Mann-Whitney)|||||0.089|0|<0.0001
70893903|NCT00321854|141274917|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.0||||0.0489||95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|||||5|0|0.0489
70893904|NCT00321854|141274918|SUPERIORITY_OR_OTHER||Median Difference (Net)|3.0||||0.0282||95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|||||5|0|0.0282
70893905|NCT00321854|141274934|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|2.5||0.8397||95.0|-5.4|4.4|||ANCOVA|||||4.4|-5.4|0.8397
70893906|NCT03204279|141274941|OTHER|No comparison between the two dose groups is performed, thus no statistical test is applied. In the next section the goodness of fit of the loess function correlating exposure and response is reported.|Pearson R|0.076||||0.55|TWO_SIDED|||||CR in the delayed phase vs AUC0-inf|loess (Local regression or polynomial)|The p-value represents the probability found if the correlation coefficient was zero (null hypothesis).|R is the Pearson correlation is a coefficient statistic that measures linear correlation between two variables CR in the delayed phase vs AUC0-inf|The population consist of all patients having CR in the delayed phase and AUC0-inf and Cmax, there is no comparison between the two dose groups.||||0.55
70893907|NCT03204279|141274941|OTHER|No comparison between the two dose groups is performed, thus no statistical test is applied. In the next section the goodness of fit of the loess function correlating exposure and response is reported.|Pearson R|-0.041||||0.75|TWO_SIDED|||||CR in the delayed phase vs Cmax|loess (Local regression or polynomial)|The p-value represents the probability found if the correlation coefficient was zero (null hypothesis).|R is the Pearson correlation is a coefficient statistic that measures linear correlation between two variables CR in the delayed phase vs Cmax|The population consist of all patients having CR in the delayed phase and AUC0-inf and Cmax, there is no comparison between the two dose groups.||||0.75
70893908|NCT02119416|141274943|OTHER|Maximum heart rate after 2 mg/kg of caffeine compared to baseline was assessed using a mixed effects regression model. Sex and pubertal stage were included in the model as time invariant predictors.|||||<|0.05||||||The p-value was not adjusted for multiple comparisons.|mixed effects regression|||||||<0.05
70893909|NCT02119416|141274943|OTHER|We compared means of our dependent variables after administration of different doses of caffeine.|||||<|0.05||||||The p-value was set prior to the analysis and all comparisons were planned.|ANCOVA|||We used repeated measures ANOVAS and conducted planned comparisons between groups as post-hoc tests.||||< 0.05
70893910|NCT02119416|141274944|OTHER|mixed effects regression models were used with sex and pubertal stage as time invariant predictors.|||||<|0.05|||||||mixed effects regression|||order was included in the analysis. We examined caffeine dose.||||<0.05
70893911|NCT02119416|141274944|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
70893912|NCT03593655|141274974|SUPERIORITY||incidence rate ratio|1.01||||0.92|TWO_SIDED|95.0|0.9|1.12||the a priori threshold for statistical significance was \<0.05|generalized estimating equation|Poisson (log) link, adjusted for period, offset of number of visits per period, exchangeable correlation structure, and robust errors.|The incidence rate ratio compares FTC/TDF to the dapivirine vaginal ring.|Comparison of the proportion of participants experiencing a grade 2 adverse event between products, with a null hypothesis of no difference.||1.12|0.90|0.92
70893913|NCT01981564|141275033|SUPERIORITY|||||||0.06|||||||ANOVA|||ANOVA F=3.55, df=1, p=0.06||||0.06
70893914|NCT03732209|141275035|SUPERIORITY||F value, group x time interaction|7.155||||0.017|TWO_SIDED|||||This p value reflects the interaction between group (episodic future thinking, control) and time (baseline, Week 8)|ANOVA||Reported values in outcome measures data table reflect mean change in glycosylated hemoglobin for each group (Session 2 - Session 1)|Due to minimal data being available at Weeks 16 and 24 due to COVID-19-related attrition, only baseline (Week 0) and Week 8 data were included in the analysis.||||.017
70963626|NCT04427501|141432112|SUPERIORITY||Odds Ratio (OR)|0.37||||0.165|TWO_SIDED|95.0|0.09|1.51|||Regression, Logistic|||||1.51|0.09|0.165
70893915|NCT03732209|141275036|SUPERIORITY||F value, group x time interaction|4.885||||0.042|TWO_SIDED|||||This p value reflects the interaction between group (episodic future thinking, control) and time (baseline, Week 8)|ANOVA||The values reported in the outcome measures data table reflect mean change in AUC (Session 2 - Session 1)|Due to minimal data being available at Weeks 16 and 24 due to COVID-19-related attrition, only baseline (Week 0) and Week 8 data were included in the analysis.||||.042
70893916|NCT03732209|141275037|SUPERIORITY||F value, group x time interaction|2.33||||0.146|TWO_SIDED|||||This p value reflects the interaction between group (episodic future thinking, control) and time (baseline, Week 8)|ANOVA|||Due to minimal data available at Week 16 and 24 due to COVID-19-related attrition, only ratings from Week 8 were included in the analysis.||||.146
70893917|NCT03732209|141275038|SUPERIORITY||Median Difference (Final Values)|1.23||||0.042|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Due to minimal data available at Week 16 and 24 due to COVID-19-related attrition, only ratings from Week 8 were included in the analysis.||||.042
70893918|NCT05046795|141275039|SUPERIORITY||Mean Difference (Net)|150.91|STANDARD_ERROR_OF_MEAN|23.727|<|0.0001|TWO_SIDED|95.0|104.145|197.671|||Mixed Models Analysis|||||197.671|104.145|<0.0001
70893919|NCT05046795|141275040|SUPERIORITY||Mean Difference (Net)|144.35|STANDARD_ERROR_OF_MEAN|21.192|<|0.0001|TWO_SIDED|95.0|102.61|186.088|||Mixed Models Analysis|||||186.088|102.610|<0.0001
70893920|NCT05046795|141275041|SUPERIORITY||Mean Difference (Net)|287.75|STANDARD_ERROR_OF_MEAN|38.473|<|0.0001|TWO_SIDED|95.0|211.933|363.57|||Mixed Models Analysis|||||363.570|211.933|<0.0001
70893921|NCT05046795|141275042|SUPERIORITY||Mean Difference (Net)|105.9|STANDARD_ERROR_OF_MEAN|16.89|<|0.0001|TWO_SIDED|95.0|72.6|139.12|||ANCOVA|||||139.12|72.60|<0.0001
70893922|NCT05046795|141275043|SUPERIORITY||Mean Difference (Net)|154.8|STANDARD_ERROR_OF_MEAN|28.37|<|0.0001|TWO_SIDED|95.0|98.86|210.78|||ANCOVA|||||210.78|98.86|<0.0001
70893923|NCT05046795|141275044|SUPERIORITY||Mean Difference (Net)|-4.9|STANDARD_ERROR_OF_MEAN|1.8||0.0064|TWO_SIDED|95.0|-8.49|-1.4|||ANCOVA|||||-1.40|-8.49|0.0064
70893924|NCT05046795|141275045|SUPERIORITY||Odds Ratio (OR)|2.1||||0.0144|TWO_SIDED|95.0|1.16|3.84|||Regression, Logistic|||||3.84|1.16|0.0144
70893925|NCT02647359|141275092|OTHER||Least Square (LS) Mean Difference|10.76||||0.4868|TWO_SIDED|95.0|-21.914|43.434||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) with age and baseline Maximum Reading Speed (both eyes) as covariates, and treatment as a factor.||43.434|-21.914|0.4868
70893926|NCT04818346|141275115|SUPERIORITY||Least squares mean difference|-21.41|STANDARD_ERROR_OF_MEAN|6.62||0.0015|TWO_SIDED|95.0|-34.49|-8.32|||Mixed Model Repeated Measures (MMRM)|||||-8.32|-34.49|0.0015
70893927|NCT04818346|141275115|SUPERIORITY||Least squares mean difference|-20.07|STANDARD_ERROR_OF_MEAN|6.86||0.004|TWO_SIDED|95.0|-33.63|-6.51|||MMRM|||||-6.51|-33.63|0.0040
70893928|NCT04818346|141275115|SUPERIORITY||Least squares mean difference|-18.02|STANDARD_ERROR_OF_MEAN|6.77||0.0086|TWO_SIDED|95.0|-31.4|-4.64|||MMRM|||||-4.64|-31.40|0.0086
70893929|NCT04818346|141275116|SUPERIORITY||Odds Ratio (OR)|4.3||||0.3574|TWO_SIDED|95.0|0.398|220.998|||Wald test||Logistic regression: (response at Week 24 = treatment + stratification factor \[T-BSA involvement 8%-20%/\>20%\]).|||220.998|0.398|0.3574
70893930|NCT04818346|141275116|SUPERIORITY||Odds Ratio (OR)|5.5||||0.1992|TWO_SIDED|95.0|0.573|273.479|||Wald test||Logistic regression: (response at Week 24 = treatment + stratification factor \[T-BSA involvement 8%-20%/\>20%\]).|||273.479|0.573|0.1992
70893931|NCT04818346|141275116|SUPERIORITY||Odds Ratio (OR)|2.1||||0.9913|TWO_SIDED|95.0|0.103|126.386|||Wald test||Logistic regression: (response at Week 24 = treatment + stratification factor \[T-BSA involvement 8%-20%/\>20%\]).|||126.386|0.103|0.9913
70893932|NCT01581281|141275159|SUPERIORITY||Odds Ratio (OR)|0.71||||0.2636|TWO_SIDED|98.3|0.34|1.48||A Bonferroni approach was used to control the type I error rate. Because there were three comparisons, the Bonferroni corrected level of significance is 0.017 (= 0.05 / 3).|Regression, Logistic|||"Logistic regression models were used to estimate the odds of successful primary endpoint for amitriptyline relative to placebo. The analyses followed the intention to treat principle, imputing an outcome of failure for any participant who withdrew early for any reason or did not provide week 24 headache diary data (endpoint data). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days)."||1.48|0.34|0.2636
70893933|NCT01581281|141275159|SUPERIORITY||Odds Ratio (OR)|0.81||||0.4821|TWO_SIDED|98.3|0.39|1.68||A Bonferroni approach was used to control the type I error rate. Because there were three comparisons of interest, the Bonferroni corrected level of significance is 0.017 ( = 0.05 / 3).|Regression, Logistic|||"Logistic regression models were used to estimate the odds of successful primary endpoint for topiramate relative to placebo. The analyses followed the intention to treat principle, imputing an outcome of failure for any participant who withdrew early for any reason or did not provide week 24 headache diary data (endpoint data). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days)."||1.68|0.39|0.4821
70893934|NCT01581281|141275159|SUPERIORITY||Odds Ratio (OR)|0.88||||0.6107|TWO_SIDED|98.3|0.49|1.59||A Bonferroni approach was used to control the type I error rate. Because there were three comparisons of interest, the Bonferroni corrected level of significance is 0.017 ( = 0.05 / 3).|Regression, Logistic|||"Logistic regression models were used to estimate the odds of successful primary endpoint for topiramate relative to amitriptyline. The analyses followed the intention to treat principle, imputing an outcome of failure for any participant who withdrew early for any reason or did not provide week 24 headache diary data (endpoint data). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days)."||1.59|0.49|0.6107
70893935|NCT01581281|141275160|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.9137|TWO_SIDED|95.0|-6.64|5.95|||Regression, Linear|||The mean change from baseline in PedMIDAS score over time for the three groups was assessed using a linear regression model for each of the three pairwise comparisons (Amitriptyline relative to placebo, Topiramate relative to placebo, and Amitriptyline relative to Topiramate), adjusted for the baseline PedMIDAS score. The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).||5.95|-6.64|0.9137
70963627|NCT04427501|141432112|SUPERIORITY||Odds Ratio (OR)|0.39||||0.191|TWO_SIDED|95.0|0.1|1.6|||Regression, Logistic|||||1.60|0.10|0.191
70963628|NCT04427501|141432112|SUPERIORITY||Odds Ratio (OR)|0.21||||0.075|TWO_SIDED|95.0|0.04|1.18|||Regression, Logistic|||||1.18|0.04|0.075
70963629|NCT04427501|141432113|SUPERIORITY|||||||0.616|||||||Stratified Log-rank|||||||0.616
70893936|NCT01581281|141275160|SUPERIORITY||Median Difference (Final Values)|-4.84||||0.1331|TWO_SIDED|95.0|-11.16|1.49|||Regression, Linear|||The mean change from baseline in PedMIDAS score over time for the three groups was assessed using a linear regression model for each of the three pairwise comparisons (Amitriptyline relative to placebo, Topiramate relative to placebo, and Amitriptyline relative to Topiramate), adjusted for the baseline PedMIDAS score. The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).||1.49|-11.16|0.1331
70893937|NCT01581281|141275160|SUPERIORITY||Mean Difference (Final Values)|4.49||||0.1011|TWO_SIDED|95.0|-0.88|9.87|||Regression, Linear|||The mean change from baseline in PedMIDAS score over time for the three groups was assessed using a linear regression model for each of the three pairwise comparisons (Amitriptyline relative to placebo, Topiramate relative to placebo, and Amitriptyline relative to Topiramate), adjusted for the baseline PedMIDAS score. The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).||9.87|-0.88|0.1011
70893938|NCT01581281|141275161|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.3553|TWO_SIDED|98.3|-2.59|1.15||Each comparison was tested using a Bonferroni corrected significance level of 0.017 (0.05/3).|Regression, Linear|||Another major secondary objective was to determine if the change in absolute headache days from baseline to week 24 differed between treatment groups. This objective was assessed using linear regression models, with three pairwise comparisons between treatment groups (Amitriptyline vs. Placebo, Topiramate vs. Placebo, and Amitriptyline vs. Topiramate). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).||1.15|-2.59|0.3553
70893939|NCT01581281|141275161|SUPERIORITY||Median Difference (Final Values)|-0.64||||0.4143|TWO_SIDED|98.3|-2.52|1.24||Each comparison was tested using a Bonferroni corrected significance level of 0.017 (0.05/3).|Regression, Linear|||Another major secondary objective was to determine if the change in absolute headache days from baseline to week 24 differed between treatment groups. This objective was assessed using linear regression models, with three pairwise comparisons between treatment groups (Amitriptyline vs. Placebo, Topiramate vs. Placebo, and Amitriptyline vs. Topiramate). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).||1.24|-2.52|0.4143
70893940|NCT01581281|141275161|SUPERIORITY||Median Difference (Final Values)|-0.08||||0.9038|TWO_SIDED|98.3|-1.68|1.52||Each comparison was tested using a Bonferroni corrected significance level of 0.017 (0.05/3).|Regression, Linear|||Another major secondary objective was to determine if the change in absolute headache days from baseline to week 24 differed between treatment groups. This objective was assessed using linear regression models, with three pairwise comparisons between treatment groups (Amitriptyline vs. Placebo, Topiramate vs. Placebo, and Amitriptyline vs. Topiramate). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).||1.52|-1.68|0.9038
70893941|NCT01581281|141275162|SUPERIORITY||Odds Ratio (OR)|2.07||||0.1557|TWO_SIDED|95.0|0.85|5.05|||Fisher Exact|||Tolerability was assessed by calculating the percent of subjects who completed the entire 24 week treatment period and the corresponding 95% confidence intervals for each treatment group. Concerns regarding tolerability would be raised if the upper bound of a confidence interval was less than 65% or if the percent of subjects who completed the entire 24 week treatment period in either of the active treatment groups was significantly less than the placebo group.||5.05|0.85|0.1557
70893942|NCT01581281|141275162|SUPERIORITY||Odds Ratio (OR)|2.31||||0.0754|TWO_SIDED|95.0|0.95|5.62|||Fisher Exact|||Tolerability was assessed by calculating the percent of subjects who completed the entire 24 week treatment period and the corresponding 95% confidence intervals for each treatment group. Concerns regarding tolerability would be raised if the upper bound of a confidence interval was less than 65% or if the percent of subjects who completed the entire 24 week treatment period in either of the active treatment groups was significantly less than the placebo group.||5.62|0.95|0.0754
70893943|NCT01581281|141275162|SUPERIORITY||Odds Ratio (OR)|0.89||||0.7611|TWO_SIDED|95.0|0.49|1.62|||Fisher Exact|||Tolerability was assessed by calculating the percent of subjects who completed the entire 24 week treatment period and the corresponding 95% confidence intervals for each treatment group. Concerns regarding tolerability would be raised if the upper bound of a confidence interval was less than 65% or if the percent of subjects who completed the entire 24 week treatment period in either of the active treatment groups was significantly less than the placebo group.||1.62|0.49|0.7611
70893944|NCT01581281|141275163|SUPERIORITY|||||||0.3038|||||||Fisher Exact|||The occurrence of treatment-related SAE's was assessed in two ways: 1) percentage of subjects who experience any treatment-related SAE in each of the three groups was compared using Fishers exact test; 2) rates of treatment-emergent SAS's across the three groups were compared using a Poisson regression model. However, due to the small number of SAEs that were deemed treatment-emergent (4 in AMI, 1 in TPM, 0 in PBO), the parameter estimates did not converge for the Poisson regression model.||||0.3038
70893945|NCT01581281|141275163|SUPERIORITY|||||||1|||||||Fisher Exact|||The occurrence of treatment-related SAE's was assessed in two ways: 1) percentage of subjects who experience any treatment-related SAE in each of the three groups was compared using Fishers exact test; 2) rates of treatment-emergent SAS's across the three groups were compared using a Poisson regression model. However, due to the small number of SAEs that were deemed treatment-emergent (4 in AMI, 1 in TPM, 0 in PBO), the parameter estimates did not converge for the Poisson regression model.||||1.000
70893946|NCT01581281|141275163|SUPERIORITY|||||||0.2139|||||||Fisher Exact|||The occurrence of treatment-related SAE's was assessed in two ways: 1) percentage of subjects who experience any treatment-related SAE in each of the three groups was compared using Fishers exact test; 2) rates of treatment-emergent SAS's across the three groups were compared using a Poisson regression model. However, due to the small number of SAEs that were deemed treatment-emergent (4 in AMI, 1 in TPM, 0 in PBO), the parameter estimates did not converge for the Poisson regression model.||||0.2139
70893947|NCT02522715|141275197|OTHER||||||<|0.01|||||||two-sided exact binomial test|||One-sample binomial test with null hypothesis that the percentage of participants with PSA response 1 is equal to 25%.||||<0.01
70893948|NCT01808313|141275205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.59|||<|0.001|TWO_SIDED|95.0|42.53|64.66|||t-test, 2 sided|||||64.66|42.53|<0.001
70893949|NCT01808313|141275206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|64.36|||<|0.001|TWO_SIDED|95.0|48.72|80.0|||t-test, 2 sided|||||80.00|48.72|<0.001
70893950|NCT01808313|141275208|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon signed-rank test|||Week 12||||<0.001
70893951|NCT01808313|141275208|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon signed-rank test|||Week 24||||0.003
70893952|NCT01808313|141275209|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.44|||<|0.001|TWO_SIDED|95.0|0.366|0.519|||Wilcoxon signed-rank test||Week 12|||0.519|0.366|<0.001
70893953|NCT01808313|141275209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|||<|0.001|TWO_SIDED|95.0|0.303|0.453|||Wilcoxon signed-rank test||Week 24|||0.453|0.303|<0.001
70893954|NCT03980470|141275231|SUPERIORITY|||||||0.198|||||||ANOVA|||||||0.198
70893955|NCT03980470|141275232|SUPERIORITY|||||||0.9|||||||ANOVA|||||||0.9
70893956|NCT03980470|141275233|SUPERIORITY|||||||0.8|||||||ANOVA|||||||0.8
70893957|NCT03980470|141275234|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70893958|NCT03980470|141275235|OTHER|Bland-Altmann analysis (bias)|Mean Difference (Final Values)|-1.42|||||TWO_SIDED|||||||||||||
70893959|NCT03858803|141275236|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
70893960|NCT03858803|141275237|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
70893961|NCT03858803|141275238|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
70893962|NCT03858803|141275239|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
70893963|NCT03858803|141275240|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
70893964|NCT03858803|141275241|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
70893965|NCT03858803|141275242|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
70893966|NCT03858803|141275243|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
70893967|NCT03858803|141275244|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
70893968|NCT03858803|141275245|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
70893969|NCT03858803|141275246|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
70893970|NCT00377234|141275406|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Null hypothesis: Preference rate (including patients not expressing treatment preference and considering order treatments were received) for monthly ibandronate = 50%. Null hypothesis is rejected if P-value was below significance threshold of P \<0.05|Garts Test|||||||<0.0001
70893971|NCT00377234|141275406|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The reported p-values for the primary analysis test whether the overall preference rate for ibandronate equals 50%. Preference within each sequence is not tested.|Prescott Test|||||||<0.0001
70893972|NCT01880424|141275411|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.001||95.0|1.21|2.09||Statistical significance (p\<0.05) was required in both co-primary efficacy parameters to meet the primary efficacy objective; both p-values met this criterion.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for geographic region|Odds ratio for response rate (linaclotide : placebo)|Null Hypothesis: There is no difference between the linaclotide dose and placebo in the proportion of 12-week Abdominal Pain/Abdominal Discomfort Responders or there is no difference in the proportion of 12-week IBS Degree of Relief Responders. With 800 planned patients, the statistical power was expected to be approximately 95%, with an overall type I error rate controlled at the 0.05 level (2-sided), based on assumptions from NCT00948818 (LIN-MD-31) study data.||2.09|1.21|0.0010
70893973|NCT01880424|141275412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.56|||<|0.0001||95.0|1.83|3.58||Statistical significance (p\<0.05) was required in both co-primary efficacy parameters to meet the primary efficacy objective; both p-values met this criterion.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for geographic region|Odds ratio for response rate (linaclotide : placebo)|Null Hypothesis: There is no difference between the linaclotide dose and placebo in the proportion of 12-week Abdominal Pain/Abdominal Discomfort Responders or there is no difference in the proportion of 12-week IBS Degree of Relief Responders. With 800 planned patients, the statistical power was expected to be approximately 95%, with an overall type I error rate controlled at the 0.05 level (2-sided), based on assumptions from NCT00948818 (LIN-MD-31) study data.||3.58|1.83|<0.0001
70893974|NCT01983293|141275425|SUPERIORITY|||||||0.001|ONE_SIDED|95.0|||||Fisher Exact|||||||0.001
70893975|NCT01944631|141275432|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.613|STANDARD_ERROR_OF_MEAN|0.359||0.0895|TWO_SIDED|95.0|-1.321|0.095|||ANCOVA||Difference calculated as bisolviral minus placebo|||0.095|-1.321|0.0895
70893976|NCT01944631|141275433|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.176|STANDARD_ERROR_OF_MEAN|0.146||0.231|TWO_SIDED|95.0|-0.464|0.113|||ANCOVA||Difference calculated as bisolviral minus placebo|||0.113|-0.464|0.2310
70893977|NCT01944631|141275434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.443|STANDARD_ERROR_OF_MEAN|0.304||0.1465|TWO_SIDED|95.0|-1.042|0.156|||ANCOVA||Difference calculated as bisolviral minus placebo|||0.156|-1.042|0.1465
70893978|NCT01944631|141275435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.728|STANDARD_ERROR_OF_MEAN|3.102||0.8148|TWO_SIDED|95.0|-5.39|6.845|||ANCOVA||Difference calculated as bisolviral minus placebo|||6.845|-5.390|0.8148
70893979|NCT01944631|141275436|SUPERIORITY_OR_OTHER|||||||0.1887|TWO_SIDED||||||Log Rank|Log-rank test stratifying for the variable 'baseline TSS'||||||0.1887
70893980|NCT01944631|141275437|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1069||||0.6954|TWO_SIDED|95.0|0.666|1.84|||Regression, Logistic||A value greater than one favours bisolviral|||1.840|0.666|0.6954
70893981|NCT02388724|141275439|NON_INFERIORITY|If the lower bound of the 95% confidence intervals of the difference was more than -10% (non-inferiority margin), non-inferiority for Vonoprazan relative to Lansoprazole was declared.|Difference in percentages|1.1|||||TWO_SIDED|95.0|-3.822|6.087||||||||6.087|-3.822|
70893982|NCT02388724|141275440|SUPERIORITY||Difference in percentages|7.2|||||TWO_SIDED|95.0|-1.054|15.371||||||2 Weeks||15.371|-1.054|
70893983|NCT02388724|141275440|SUPERIORITY||Difference in percentages|1.8|||||TWO_SIDED|95.0|-4.763|8.395||||||4 Weeks||8.395|-4.763|
70893984|NCT02605954|141275451|NON_INFERIORITY|With 200 participants randomized to switch to the E/C/F/TAF FDC group at Day 1 and 100 participants randomized to the ABC/3TC+3rd Agent group at Week 24, the lower limit of the observed one sided 97.5% confidence interval was expected to be greater than -0.120 (ie, non-inferiority margin of 12%) with \> 90% power when the percentage of responders in both treatment groups for the primary endpoint is at least 90% at Week 24.|Difference in Percentages|-4.4||||0.15|TWO_SIDED|95.0|-9.4|1.9|||Fisher Exact|||||1.9|-9.4|0.15
70893985|NCT02605954|141275452|NON_INFERIORITY|With 200 participants randomized to switch to the E/C/F/TAF FDC group at Day 1 and 100 participants randomized to the delayed switch group at Week 12, the lower limit of the observed one sided 97.5% confidence interval will be expected to be greater than -0.120 (ie, non-inferiority margin of 12%) with \> 90% power when the percentage of responders in both treatment groups for the primary endpoint is at least 90% at Week 12.|Difference in Percentages|-3.8||||0.17|TWO_SIDED|95.0|-8.3|1.6|||Fisher Exact|||||1.6|-8.3|0.17
70893986|NCT02605954|141275454|OTHER||Difference in least square mean|-36.0||||0.11|TWO_SIDED|95.0|-80.0|9.0|||ANOVA|||||9|-80|0.11
70893987|NCT03814889|141275653|OTHER|||||||0.00025|||||||Wilcoxon Signed-Rank|Paired, ordinal data||||||0.00025
70893988|NCT03814889|141275654|OTHER|||||||0.0014|||||||Wilcoxon Signed-Rank|||||||0.0014
70893989|NCT03814889|141275655|OTHER|||||||0.02|||||||t-test, 1 sided|||||||0.02
70893990|NCT03814889|141275656|OTHER|||||||0.001|||||||t-test, 1 sided|||||||0.001
70893991|NCT03814889|141275659|OTHER|||||||0.001|||||||Wilcoxcon Signed-Ranks|||||||0.001
70893992|NCT00413153|141275665|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||t-test, 2 sided|||Initial samples size of N=16 calculated to provide 80% power to detect a 30% change in muscle glucose uptake between groups. Student's t-test used to compare change from baseline and determine treatment effect (net difference over time between the ATV/r vs. LPV/r groups).||||0.035
70893993|NCT00413153|141275666|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Repeated measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs. LPV/r)||||0.12
70893994|NCT00413153|141275667|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Repeated Measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).||||0.002
70893995|NCT00413153|141275668|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Repeated measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).||||0.02
70893996|NCT00413153|141275669|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||t-test, 2 sided|||||||0.047
70893997|NCT00413153|141275670|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||Repeated Measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).||||0.72
70893998|NCT00413153|141275671|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Repeated Measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).||||0.22
70893999|NCT00413153|141275672|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Repeated Measures Ancova|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).||||0.004
70894000|NCT00413153|141275673|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Repeated Measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).||||0.0002
70894001|NCT01221597|141275796|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||ANOVA|||||||0.0005
70894002|NCT01221597|141275797|SUPERIORITY_OR_OTHER|||||||0.0451|TWO_SIDED||||||ANOVA|||||||0.0451
70894003|NCT01221597|141275798|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
70894004|NCT01221597|141275799|SUPERIORITY_OR_OTHER|||||||0.0268|TWO_SIDED||||||ANOVA|||||||0.0268
70894005|NCT01221597|141275800|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||ANOVA|||||||0.0800
70894006|NCT01221597|141275801|SUPERIORITY_OR_OTHER|||||||0.3085|TWO_SIDED||||||ANOVA|||||||0.3085
70894007|NCT01221597|141275802|SUPERIORITY_OR_OTHER|||||||0.6321|TWO_SIDED||||||ANOVA|||||||0.6321
70894008|NCT01221597|141275803|SUPERIORITY_OR_OTHER|||||||0.7965|TWO_SIDED||||||ANOVA|||||||0.7965
70894009|NCT01221597|141275804|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
70894010|NCT01059565|141275824|SUPERIORITY_OR_OTHER||Difference in least squares mean (LSM)|0.91||||0.663|TWO_SIDED|95.0|-3.24|5.06||"To correct for multiplicity, a family alpha spending rule was used to control the type 1 error rate of alpha=0.05.~A gate-keeping procedure to control family-wise Type 1 error was established a priori for primary and key secondary endpoints."|ANCOVA|Baseline was included as a covariate in this model.||"The primary analysis was a test for superiority. Null hypothesis was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.~A sample size of 50 participants per group provided at least 80% power to detect an 8.5% difference in mean AUCave of relative change from baseline in FEV1 % predicted through Week 24 using a two-sided 0.05-level test, assuming a common standard deviation of 15."||5.06|-3.24|0.663
70894011|NCT01059565|141275825|SUPERIORITY_OR_OTHER|||||||0.4158||||||To correct for multiplicity, a family alpha spending rule was used to control the type 1 error rate of alpha=0.05.|Negative binomial regression|The negative binomial regression model included an offset parameter which accounted for potential differing study durations due to discontinuations.||The primary analysis was a test for superiority. Null hypothesis was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||||0.4158
70894012|NCT01059565|141275826|SUPERIORITY_OR_OTHER||Difference in LSM|0.18||||0.939|TWO_SIDED|95.0|-4.43|1.78||To correct for multiplicity, a family alpha spending rule was used to control the type 1 error rate of alpha=0.05.|ANCOVA|The AUCs of changes from baseline were compared between treatment groups using ANCOVA methods with baseline value as a covariate.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||1.78|-4.43|0.939
70894013|NCT01059565|141275827|SUPERIORITY_OR_OTHER||Difference in LSM|0.77||||0.711|TWO_SIDED|95.0|-3.33|4.86|||ANCOVA|The AUCs of changes from baseline were compared between treatment groups using ANCOVA methods with baseline value as a covariate.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||4.86|-3.33|0.711
70894014|NCT01059565|141275828|SUPERIORITY_OR_OTHER||Difference in LSM|0.6||||0.762|TWO_SIDED|95.0|-3.3|4.49|||ANCOVA|The AUCs of changes from baseline were compared between treatment groups using ANCOVA methods with baseline value as a covariate.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||4.49|-3.30|0.762
70894015|NCT01059565|141275829|SUPERIORITY_OR_OTHER||Difference in LSM|1.95||||0.553|TWO_SIDED|95.0|-4.54|8.44|||ANCOVA|The AUCs of changes from baseline were compared between treatment groups using ANCOVA methods with baseline value as a covariate.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||8.44|-4.54|0.553
70894016|NCT01059565|141275830|SUPERIORITY_OR_OTHER||Difference in LSM|2.99||||0.17|TWO_SIDED|95.0|-1.2|7.28|||ANCOVA|Baseline was included as a covariate in this model.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||7.28|-1.20|0.170
70894017|NCT01059565|141275831|SUPERIORITY_OR_OTHER||Difference in LSM|-2.57||||0.528|TWO_SIDED|95.0|-10.62|5.49|||ANCOVA|Baseline was included as a covariate in this model.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||5.49|-10.62|0.528
70894018|NCT01059565|141275832|SUPERIORITY_OR_OTHER||Difference in LSM|3.62||||0.132|TWO_SIDED|95.0|-1.11|8.34|||ANCOVA|Baseline was included as a covariate in this model.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||8.34|-1.11|0.132
70894019|NCT01059565|141275833|SUPERIORITY_OR_OTHER||Difference in LSM|0.14||||0.531|TWO_SIDED|95.0|-0.29|0.56|||Mixed Models Analysis|P-value was based on a Mixed-Effect Model Repeated Measure model that included terms for treatment, visit, baseline, and treatment/visit interaction.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||0.56|-0.29|0.531
70894020|NCT01059565|141275834|SUPERIORITY_OR_OTHER||Difference in LSM|0.93||||0.232|TWO_SIDED|95.0|-0.62|2.48|||ANCOVA|Baseline was included as a covariate in this model.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||2.48|-0.62|0.232
70894021|NCT01059565|141275835|SUPERIORITY_OR_OTHER|||||||0.103|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||||0.103
70894022|NCT01059565|141275836|SUPERIORITY_OR_OTHER|||||||0.646|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||||0.646
70894023|NCT01059565|141275837|SUPERIORITY_OR_OTHER|||||||0.284|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||||0.284
70894024|NCT04773587|141275898|SUPERIORITY||Odds Ratio (OR)|2.96|||<|0.0001|TWO_SIDED|95.0|1.881|4.647|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Difference in vIGA-AD Success at Week 4||4.647|1.881|<0.0001
70894025|NCT04773587|141275899|SUPERIORITY||Odds Ratio (OR)|2.67|||<|0.0001|TWO_SIDED|95.0|1.64|4.359|||Cochran-Mantel-Haenszel|Stratified by pooled study site with multiple imputation of missing observations|Stratified by pooled study site with multiple imputation of missing observations|Difference in vIGA-AD Success at Week 4||4.359|1.640|<0.0001
70894026|NCT04773587|141275900|SUPERIORITY||Odds Ratio (OR)|1.98||||0.0089|TWO_SIDED|95.0|1.186|3.319|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|WI-NRS Success at Week 4||3.319|1.186|0.0089
70894027|NCT04773587|141275901|SUPERIORITY||Odds Ratio (OR)|2.81||||0.0016|TWO_SIDED|95.0|1.45|5.457|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|WI-NRS Success at Week 2||5.457|1.450|0.0016
70894028|NCT04773587|141275902|SUPERIORITY||Odds Ratio (OR)|3.81||||0.0159|TWO_SIDED|95.0|1.161|12.511|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|WI-NRS Success at Week 1||12.511|1.161|0.0159
70894029|NCT04773587|141275903|SUPERIORITY||Odds Ratio (OR)|3.17|||<|0.0001|TWO_SIDED|95.0|2.102|4.795|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|EASI-75 at Week 4||4.795|2.102|<0.0001
70894030|NCT04773587|141275904|SUPERIORITY||Odds Ratio (OR)|2.56|||<|0.0001|TWO_SIDED|95.0|1.707|3.843|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study stie and vIGA-AD randomization strata with multiple imputation of missing observations|vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 4||3.843|1.707|<0.0001
70894031|NCT04773587|141275905|SUPERIORITY||Odds Ratio (OR)|4.28|||<|0.0001|TWO_SIDED|95.0|2.31|7.926|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|vIGA-AD Success at Week 2||7.926|2.310|<0.0001
70894032|NCT04773587|141275906|SUPERIORITY||Odds Ratio (OR)|25.41|||<|0.0001|TWO_SIDED|95.0|2.815|229.388|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|vIGA-AD Success at Week 1||229.388|2.815|<0.0001
70894033|NCT04773587|141275907|SUPERIORITY||Odds Ratio (OR)|3.62|||<|0.0001|TWO_SIDED|95.0|2.217|5.911|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 2||5.911|2.217|<0.0001
70894034|NCT04773587|141275908|SUPERIORITY||Odds Ratio (OR)|3.46||||0.0002|TWO_SIDED|95.0|1.705|7.007|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 1||7.007|1.705|0.0002
70894035|NCT00622167|141275922|SUPERIORITY_OR_OTHER|||||||0||0.0|||||Not done|||Plaque characteristics including plaque cross-sectional diameter, area measurements, plaque volume, and plaque morphology would be compared between IBIVUS, DSCT and angiography.||||0
70963630|NCT04427501|141432113|SUPERIORITY|||||||0.281|||||||Stratified Log-rank|||||||0.281
70894036|NCT00765193|141275980|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.36|||<|0.01||95.0|2.12|2.62|||Regression, Logistic|||The primary outcomes were the calculation of the absolute and relative risks of missing a skin cancer when TBSE is not performed, as well as the number of patients needed to examine by TBSE to find a skin cancer. The secondary outcome was to assess the magnitude of false-positive results obtained by TBSE||2.62|2.12|<0.01
70894037|NCT04370054|141275997|NON_INFERIORITY|A repeated measures negative binomial regression model was used to test non-inferiority with non-inferiority margin = 3 bleeds/year at the one-sided alpha level = 0.025.|Mean Difference (Final Values)|-3.49|||=|0.004|TWO_SIDED|95.0|-6.06|-0.91||One-sided p-value is reported.|Generalized linear model (GLM)||Difference in mean = Mean PF-07055480 Total ABR - Mean FVIII Prophylaxis Total ABR.|A repeated measures GLM was used with bleeds as dependent variable in negative binomial distribution, an interaction of duration by treatment, and 'participant' as random and treatment \& duration of follow-up as fixed effect.||-0.91|-6.06|=0.0040
70894038|NCT04370054|141275998|SUPERIORITY||||||=|0.0086||||||One-sided p-value is reported.|One-sided exact binomial proportion test|||||||=0.0086
70894039|NCT04370054|141275999|NON_INFERIORITY|A repeated measures negative binomial regression model was used to test non-inferiority with non-inferiority margin = 3 bleeds/year at the one-sided alpha level = 0.025.|Mean Difference (Final Values)|-4.01|||<|0.0001|TWO_SIDED|95.0|-5.57|-2.45||One-sided p-value is reported.|Repeated measures GLM||Difference in mean = Mean PF-07055480 Total ABR - Mean FVIII Prophylaxis Total ABR.|A repeated measures GLM was used with bleeds as dependent variable in negative binomial distribution, an interaction of duration by treatment, and 'participant' as random and treatment \& duration of follow-up as fixed effect.||-2.45|-5.57|<0.0001
70894040|NCT04370054|141276000|SUPERIORITY||Mean Difference (Final Values)|-124.18|||<|0.0001|TWO_SIDED|95.0|-139.47|108.89||One-sided p-value is reported.|Paired t-test||Treatment Difference = (PF-07055480 AIR - FVIII Prophylaxis AIR).|||108.89|-139.47|<0.0001
70894041|NCT04370054|141276002|SUPERIORITY||Mean Difference (Final Values)|-4076.06|||<|0.0001|TWO_SIDED|95.0|-4728.3|-3423.8||One-sided p-value is reported.|Paired t-test||Treatment Difference (FVIII Consumption post-IP Infusion - FVIII Consumption during FVIII Prophylaxis).|||-3423.8|-4728.3|<0.0001
70894042|NCT05054816|141276042|SUPERIORITY||||||<|0.05||||||The p-value was adjusted for multiple comparisons between three conditions: investigative feature, comparative feature 1, comparative feature 2|ANOVA|The data were protected against deviations from sphericity by modifying degrees of freedom using Greenhouse-Geisser corrections.||Previous research with subjective ratings has repeatedly shown that data collected with 15-25 participants can yield significant results.||||<0.05
70894043|NCT05054816|141276043|SUPERIORITY||||||<|0.05||||||The p-value was adjusted for multiple comparisons between three conditions: investigative feature, comparative feature 1, comparative feature 2|ANOVA|The data were protected against deviations from sphericity by modifying degrees of freedom using Greenhouse-Geisser corrections||Previous research with subjective ratings has repeatedly shown that data collected with 15-25 participants can yield significant results.||||<0.05
70894044|NCT05054816|141276044|SUPERIORITY||||||<|0.05||||||The p-value was adjusted for multiple comparisons between three conditions: investigative feature, comparative feature 1, comparative feature 2|ANOVA|The data were protected against deviations from sphericity by modifying degrees of freedom using Greenhouse-Geisser corrections||Previous research with subjective ratings has repeatedly shown that data collected with 15-25 participants can yield significant results.||||<0.05
70894045|NCT05054816|141276045|SUPERIORITY||||||<|0.05||||||The p-value was adjusted for multiple comparisons between two conditions: investigative feature, comparative feature 1|ANOVA|The data were protected against deviations from sphericity by modifying degrees of freedom using Greenhouse-Geisser corrections||Previous research with subjective ratings has repeatedly shown that data collected with 15-25 participants can yield significant results.||||<0.05
70894046|NCT05054816|141276046|SUPERIORITY||||||<|0.05||||||The p-value was adjusted for multiple comparisons between three conditions: investigative feature, comparative feature 1, comparative feature 2|ANOVA|The data were protected against deviations from sphericity by modifying degrees of freedom using Greenhouse-Geisser corrections||Previous research with subjective ratings has repeatedly shown that data collected with 15-25 participants can yield significant results.||||<0.05
70894047|NCT02239679|141276158|SUPERIORITY|||||||0.0166|||||||ANCOVA|||||||0.0166
70894048|NCT02239679|141276164|SUPERIORITY|||||||0.0102||||||no adjustments for multiple comparisons|Cochran-Mantel-Haenszel|stratified by site||||||0.0102
70894049|NCT02239679|141276164|SUPERIORITY|||||||0.0089||||||no adjustment for multiple comparisons|Cochran-Mantel-Haenszel|stratified by site||||||0.0089
70894050|NCT02239679|141276165|SUPERIORITY|||||||0.0004||||||no adjustments for multiple comparisons|Cochran-Mantel-Haenszel|stratified by site||||||0.0004
70894051|NCT02239679|141276165|SUPERIORITY||||||<|0.0001||||||no adjustment for multiple comparison|Cochran-Mantel-Haenszel|stratified by site||||||<0.0001
70894052|NCT01227681|141276227|SUPERIORITY_OR_OTHER|||||||0.64|||||||t-test, 2 sided|||Null hypothesis: there is significant deterioration of UPDRS part III scores from baseline to post G-CSF injection one year||||0.64
70894053|NCT03214367|141276242|NON_INFERIORITY|Noninferiority margin = 0.4% for HbA1c|LS Mean Difference|-0.08||||0.06|TWO_SIDED|95.0|-0.16|0.0|||Mixed Models Analysis|||||0.00|-0.16|0.060
70894054|NCT03214367|141276242|NON_INFERIORITY|Noninferiority margin = 0.4% for HbA1c|LS Mean Difference|0.13||||0.003|TWO_SIDED|95.0|0.04|0.22|||Mixed Models Analysis|||||0.22|0.04|0.003
70894055|NCT03214367|141276243|SUPERIORITY||LS Mean Difference|-27.9|||<|0.001|TWO_SIDED|95.0|-35.3|-20.6|||ANCOVA|||||-20.6|-35.3|<0.001
70894056|NCT03214367|141276243|SUPERIORITY||LS Mean Difference|13.2||||0.002|TWO_SIDED|95.0|5.0|21.4|||ANCOVA|||||21.4|5.0|0.002
70894057|NCT03214367|141276244|SUPERIORITY||LS Mean Difference|-31.2|||<|0.001|TWO_SIDED|95.0|-41.1|-21.2|||ANCOVA|||||-21.2|-41.1|<0.001
70894058|NCT03214367|141276244|SUPERIORITY||LS Mean Difference|-6.7||||0.235|TWO_SIDED|95.0|-17.6|4.3|||ANCOVA|||||4.3|-17.6|0.235
70894059|NCT03214367|141276253|SUPERIORITY||LS Mean Difference|-0.06||||0.184|TWO_SIDED|95.0|-0.16|0.03|||Mixed Models Analysis|||||0.03|-0.16|0.184
70894060|NCT03508843|141276254|SUPERIORITY||||||<|0.001|||||||McNemar|||||||<.001
70894061|NCT03508843|141276255|SUPERIORITY||||||<|0.001|||||||McNemar|||||||<.001
70894062|NCT03508843|141276256|SUPERIORITY||||||>|0.05|||||||McNemar|||||||>.05
70894063|NCT00765843|141276257|SUPERIORITY_OR_OTHER|||||||0.78|||||||ANOVA|||baseline comparisons||||0.78
70894064|NCT00765843|141276257|SUPERIORITY_OR_OTHER|||||||0.21|||||||ANOVA|||one month comparisons||||0.21
70894065|NCT00765843|141276257|SUPERIORITY_OR_OTHER|||||||0.93|||||||ANOVA|||three months comparisons||||0.93
70894066|NCT03555396|141276258|SUPERIORITY||Mean Difference (Final Values)|-3.54||||0.483|TWO_SIDED|95.0|-13.53|6.46|||t-test, 2 sided|||||6.46|-13.53|0.483
70894067|NCT03555396|141276259|SUPERIORITY|||||||0.637|||||||Chi-squared|||||||0.637
70894068|NCT03555396|141276260|SUPERIORITY||Mean Difference (Net)|9.54||||0.037|TWO_SIDED|95.0|0.59|18.49||Difference in mean change in adherence from baseline to 6 month follow-up between individuals in the intervention and control arms.|Mixed Models Analysis|Multilevel linear mixed model with random effects (dyad \& intercept); adjusting for participant age, sex, baseline adherence, and partner HIV status||||18.49|0.59|0.037
70894069|NCT03555396|141276261|SUPERIORITY|||||||0.621|||||||Chi-squared|Fisher's Exact Test used for small sample sizes||||||0.621
70894070|NCT02103439|141276269|NON_INFERIORITY_OR_EQUIVALENCE|the lower limit of the 95% confidence interval for the difference in proportions between the difference in the early virological response rate with Algeron and PegIntron should be higher than the non-inferiority margin of 0.2 (-20%)||||||0.227|TWO_SIDED||||||Fisher Exact|||||||0.227
70894071|NCT02103439|141276270|NON_INFERIORITY_OR_EQUIVALENCE|the lower limit of the 95 % confidence interval between the difference in rate of rapid virological response with Algeron and PegIntron should be more than the non-inferiority margin (-20 %)|||||>|0.05|TWO_SIDED||||||Fisher Exact|||||||> 0.05
70894072|NCT01369342|141276317|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
70894073|NCT01369342|141276317|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
70894074|NCT01369342|141276318|SUPERIORITY_OR_OTHER|||||||0.009||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||0.009
70894075|NCT01369342|141276318|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
70894076|NCT01369342|141276319|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
70894077|NCT01369342|141276319|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
70894078|NCT01369342|141276320|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
70894079|NCT01369342|141276320|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
70894080|NCT01369342|141276321|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
70894081|NCT01369342|141276321|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
70894082|NCT01816594|141276322|SUPERIORITY|||||||0.811|||||||Fisher Exact|(one-sided)||All participantss||||0.811
70894083|NCT01816594|141276323|SUPERIORITY|||||||0.83|||||||Fisher Exact|(one-sided)||wild type cohort||||0.830
70894084|NCT01816594|141276324|SUPERIORITY|||||||0.786|||||||Fisher Exact|(one-sided)||mutant cohort||||0.786
70894085|NCT01816594|141276325|SUPERIORITY|||||||0.286|||||||Fisher Exact|(one-sided)||All participants||||0.286
70894086|NCT01816594|141276326|SUPERIORITY|||||||0.177|||||||Fisher Exact|(one-sided)||wild type cohort||||0.177
70894087|NCT01816594|141276327|SUPERIORITY|||||||0.929|||||||Fisher Exact|(one-sided)||mutant cohort||||0.929
70894088|NCT01816594|141276328|SUPERIORITY|||||||0.811|||||||Fisher Exact|(one-sided)||||||0.811
70894089|NCT01816594|141276329|SUPERIORITY|||||||0.84|||||||Fisher Exact|(one-sided)||||||0.840
70894090|NCT01816594|141276330|SUPERIORITY|||||||0.724|||||||Fisher Exact|(one-sided)||||||0.724
70894091|NCT01816594|141276331|SUPERIORITY|||||||0.964|||||||Fisher Exact|(one-sided)||All participants||||0.964
70894092|NCT01816594|141276332|SUPERIORITY|||||||0.546|||||||Fisher Exact|(one-sided)||For ER+ participants - pCR||||0.546
70894093|NCT01816594|141276333|SUPERIORITY|||||||0.949|||||||Fisher Exact|(one-sided)||For ER- participants - pCR||||0.949
70894094|NCT01816594|141276334|SUPERIORITY|||||||0.053|||||||Fisher Exact|(one-sided)||For ER+ participants - ORR||||0.053
70894095|NCT01816594|141276335|SUPERIORITY|||||||0.949|||||||Fisher Exact|(one-sided)||For ER- participants - ORR||||0.949
70894096|NCT01816594|141276336|SUPERIORITY|||||||0.666|||||||Fisher Exact|(one-sided)||||||0.666
70894097|NCT01816594|141276337|SUPERIORITY|||||||0.803|||||||Fisher Exact|(one-sided)||||||0.803
70894098|NCT03905655|141276338|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
70894099|NCT03905655|141276338|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
70894100|NCT03905655|141276338|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
70894101|NCT03905655|141276339|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
70894102|NCT03905655|141276339|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
70894103|NCT03905655|141276339|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
70894104|NCT03905655|141276340|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Day 3 values||||1.000
70894105|NCT03905655|141276340|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 1 values||||1.000
70894106|NCT03905655|141276340|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 2 values||||1.000
70894107|NCT03905655|141276340|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 4 values||||1.000
70894108|NCT03905655|141276340|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 8 values||||1.000
70894109|NCT03905655|141276340|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Day 3 values||||1.000
70894110|NCT03905655|141276340|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 1 values||||1.000
70894111|NCT03905655|141276340|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 2 values||||1.000
70894112|NCT03905655|141276340|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 4 values||||1.000
70894113|NCT03905655|141276340|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Comparison of Week 8 values||||0.001
70894114|NCT03905655|141276340|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Day 3 values||||1.000
70894115|NCT03905655|141276340|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 1 values||||1.000
70894116|NCT03905655|141276340|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Comparison of Week 2 values||||<0.001
70894117|NCT03905655|141276340|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||Comparison of Week 4 values||||0.002
70894118|NCT03905655|141276340|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 8 values||||1.000
70894119|NCT03905655|141276341|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
70894120|NCT03905655|141276341|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
70894121|NCT03905655|141276341|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
70894122|NCT03905655|141276341|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
70894123|NCT03905655|141276341|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
70894124|NCT03905655|141276341|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
70894125|NCT03905655|141276341|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
70894126|NCT03905655|141276341|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
70894127|NCT03905655|141276341|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
70894128|NCT03905655|141276341|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
70894129|NCT03905655|141276341|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
70894130|NCT03905655|141276341|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
70894131|NCT03905655|141276341|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
70894132|NCT03905655|141276341|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
70894133|NCT03905655|141276341|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
70894134|NCT03905655|141276341|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
70894135|NCT03905655|141276341|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
70894136|NCT03905655|141276341|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
70894137|NCT03905655|141276342|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
70894138|NCT03905655|141276342|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
70894139|NCT03905655|141276342|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
70894140|NCT03905655|141276342|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
70894141|NCT03905655|141276342|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
70894142|NCT03905655|141276342|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
70894143|NCT03905655|141276342|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
70894144|NCT03905655|141276342|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
70894145|NCT03905655|141276342|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
70894146|NCT03905655|141276342|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
70894147|NCT03905655|141276342|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
70894148|NCT03905655|141276342|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
70894149|NCT03905655|141276342|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
70894150|NCT03905655|141276342|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
70894151|NCT03905655|141276342|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
70894152|NCT03905655|141276342|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
70894153|NCT03905655|141276342|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
70894154|NCT03905655|141276342|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
70894155|NCT03905655|141276343|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
70894156|NCT03905655|141276343|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
70894157|NCT03905655|141276343|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
70894158|NCT03905655|141276343|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
70894159|NCT03905655|141276343|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
70894160|NCT03905655|141276343|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
70894161|NCT03905655|141276343|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
70894162|NCT03905655|141276343|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
70894163|NCT03905655|141276343|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
70894164|NCT03905655|141276343|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
70894165|NCT03905655|141276343|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
70894166|NCT03905655|141276343|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
70894167|NCT03905655|141276343|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
70894168|NCT03905655|141276343|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
70894169|NCT03905655|141276343|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
70894170|NCT03905655|141276343|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
70894171|NCT03905655|141276343|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
70894172|NCT03905655|141276343|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
70894173|NCT03905655|141276344|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||Comparison of Week 1 values||||0.006
70894174|NCT03905655|141276344|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||Comparison of Week 2 values||||0.003
70894175|NCT03905655|141276344|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||Comparison of Week 4 values||||0.004
70894176|NCT03905655|141276344|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||Comparison of Week 8 values||||0.006
70894177|NCT03905655|141276344|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||Comparison of Week 12 values||||0.002
70894178|NCT03905655|141276344|SUPERIORITY|||||||0.141|||||||t-test, 2 sided|||Comparison of Week 1 values||||0.141
70894179|NCT03905655|141276344|SUPERIORITY|||||||0.081|||||||t-test, 2 sided|||Comparison of Week 2 values||||0.081
70894180|NCT03905655|141276344|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||Comparison of Week 4 values||||0.160
70894181|NCT03905655|141276344|SUPERIORITY|||||||0.184|||||||t-test, 2 sided|||Comparison of Week 8 values||||0.184
70894182|NCT03905655|141276344|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||Comparison of Week 12 values||||0.046
70894183|NCT03905655|141276344|SUPERIORITY|||||||0.379|||||||t-test, 2 sided|||Comparison of Week 1 values||||0.379
70894184|NCT03905655|141276344|SUPERIORITY|||||||0.308|||||||t-test, 2 sided|||Comparison of Week 2 values||||0.308
70894185|NCT03905655|141276344|SUPERIORITY|||||||0.794|||||||t-test, 2 sided|||Comparison of Week 4 values||||0.794
70894186|NCT03905655|141276344|SUPERIORITY|||||||0.297|||||||t-test, 2 sided|||Comparison of Week 8 values||||0.297
70894187|NCT03905655|141276344|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||Comparison of Week 12 values||||0.007
70894188|NCT03905655|141276345|SUPERIORITY|||||||0.123|||||||t-test, 2 sided|||||||0.123
70894189|NCT03905655|141276345|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
70894190|NCT03905655|141276345|SUPERIORITY|||||||0.266|||||||t-test, 2 sided|||||||0.266
70894191|NCT03667053|141276389|SUPERIORITY||||||<|0.001|||||||Log Rank|||The treatment group difference between dasiglucagon and placebo was evaluated inferentially using a pairwise two-sided log rank test stratified by injection site and age group.||||<0.001
70894192|NCT03667053|141276390|SUPERIORITY|||||||0.0073||||||Assessed at 30 minutes. Note that p-value was 0.0005 at 10 minutes and \<0.0001 at 15 and 20 minutes.|Cochran-Mantel-Haenszel|||The recovery rates of dasiglucagon and placebo were compared at each time point using a Cochran-Mantel-Haenszel test stratified by age group and injection site. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||0.0073
70894193|NCT03667053|141276391|SUPERIORITY||||||<|0.0001||||||The p-value was \<0.0001 at all time points (10, 15, 20 and 30 minutes)|ANOVA|||Change from baseline in plasma glucose at 30, 20, 15, and 10 minutes after investigational product injection was calculated using nominal sampling times and analyzed using an analysis of variance model with treatment, age group and injection site for each endpoint. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
70894194|NCT00845663|141276443|NON_INFERIORITY_OR_EQUIVALENCE|Use of the 80-125 % bioequivalence range. If 90% confidence interval for ratio of geometric LS Means (percent) is included within these limits, the devices are considered bioequivalent.|ratio of geometric LS Means (percent)|101.33||||||90.0|92.84|110.58|||ANOVA|ANOVA for log-transformed values with treatment as factor has been used as the basis for calculation of estimated value and confidence interval.|Ratio is Auto-injection device/Pre-filled syringe|Bioequivalence testing by using the 90% Confidence Interval||110.58|92.84|
70894195|NCT00845663|141276444|NON_INFERIORITY_OR_EQUIVALENCE|Use of the 80-125% bioequivalence range. If 90% confidence interval for ratio of geometric LS Means (percent) is included within these limits, the devices are considered bioequivalent.|ratio of geometric LS Means (percent)|97.7||||||90.0|89.06|107.19|||ANOVA|ANOVA for log-transformed values with treatment as factor was taken as the basis for calculation of estimated value and confidence interval.|Ratio is Auto-injection device/Pre-filled syringe|Bioequivalence testing by using the 90% Confidence Interval||107.19|89.06|
70894196|NCT00845663|141276445|NON_INFERIORITY_OR_EQUIVALENCE|Use of the 80-125 % bioequivalence range. If 90% confidence interval for ratio of geometric LS Means (percent) is included within these limits, the devices are considered bioequivalent.|ratio of geometric LS Means (percent)|97.54||||||90.0|87.33|108.94|||ANOVA|ANOVA for log-transformed values with treatment as factor was taken as a basis for calculation of estimated value and the confidence interval.|Ratio is Auto-injection device/Pre-filled syringe|Bioequivalence testing by using the 90% Confidence Interval||108.94|87.33|
70894197|NCT05585307|141276484|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
70894198|NCT05585307|141276484|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
70894199|NCT05585307|141276484|SUPERIORITY|||||||0.0013||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||0.0013
70894200|NCT05585307|141276484|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
70894201|NCT05585307|141276484|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
70894202|NCT05585307|141276484|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
70894203|NCT05585307|141276484|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
70894204|NCT05585307|141276484|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
70894205|NCT05585307|141276485|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
70894206|NCT05585307|141276485|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
70894207|NCT05585307|141276485|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
70894208|NCT05585307|141276485|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
70894209|NCT05585307|141276485|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
70894210|NCT05585307|141276485|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
70894211|NCT05585307|141276485|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
70894212|NCT05585307|141276485|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
70894213|NCT04420221|141276538|SUPERIORITY||Vaccine Efficacy (VE)|-74.76||||0.8042||92.5|-680.61|36.62|||Log Rank|One-sided Group Sequential Design with non-binding beta, yielding two CIs based on cumulative alpha (92.5%) and beta (80.5%) spending|Vaccine Efficacy (VE) is defined as 1 minus the hazard ratio times 100.|||36.62|-680.61|0.8042
70894214|NCT04420221|141276539|OTHER||Vaccine Efficacy (VE)|-38.09|||||TWO_SIDED|95.0|-245.77|40.86|||||Vaccine Efficacy (VE) is defined as 1 minus the hazard ratio times 100.|||40.86|-245.77|
70894215|NCT04420221|141276540|OTHER||Vaccine Efficacy (VE)|-75.52|||||TWO_SIDED|95.0|-295.41|17.46|||||Vaccine Efficacy (VE) is defined as 1 minus the hazard ratio times 100.|||17.46|-295.41|
70894216|NCT02085408|141276563|SUPERIORITY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.94|1.3|||Regression, Cox||Hazard ratio : clofarabine/(daunorubicin \& cytarabine)|||1.30|0.94|
70894217|NCT02085408|141276564|SUPERIORITY|||||||0.94|||||||Fisher Exact|||||||0.94
70894218|NCT02273141|141276597|NON_INFERIORITY_OR_EQUIVALENCE|The confidence limits were adjusted for multiple comparisons (two alternative primary endpoints): To be declared non-inferior, the primary endpoint must show a difference in success rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in success rate|8.22||||0.038|ONE_SIDED|97.5|-0.5|||The p-value was adjusted for multiple comparisons (2 alternative primary endpoints): To be declared superior, the primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||The hypothesis was to demonstrate non-inferiority (NI) of NER1006 regimen to SP+MS (10% margin). Success rate was no. of patients with successful overall bowel cleansing as proportion of no. of patients in each group. Treatment effect was NER1006 success rate - SP+MS success rate. A Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||-0.50|0.038
70894219|NCT02273141|141276598|NON_INFERIORITY_OR_EQUIVALENCE|The confidence limits were adjusted for multiple comparisons (two alternative primary endpoints): To be declared non-inferior the primary endpoint must show a difference in success rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in excellent plus good rate|3.2||||0.027|ONE_SIDED|97.5|-5.56|||The p-value was adjusted for multiple comparisons (2 alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||Hypothesis was to demonstrate NI of NER1006 regimen to SP+MS (10% margin). Success rate was no. of patients with highly effective cleansing of the colon ascendens as proportion of no. of patients in each group. Treatment effect was NER1006 success rate - SP+MS success rate. A Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||-5.56|0.027
70894220|NCT02273141|141276599|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|2.42||||0.154|TWO_SIDED|95.0|-6.35|11.12||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to SP+MS with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 rate - SP+MS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||11.12|-6.35|0.154
70894221|NCT02273141|141276600|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|3.27||||0.212|TWO_SIDED|95.0|-5.56|11.91||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to SP+MS with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 rate - SP+MS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||11.91|-5.56|0.212
70963631|NCT04427501|141432113|SUPERIORITY|||||||0.815|||||||Stratified Log-rank|||||||0.815
70963632|NCT04427501|141432113|SUPERIORITY|||||||0.334|||||||Stratified Log-rank|||||||0.334
70894222|NCT02273141|141276601|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in PDR|4.43||||0.064|TWO_SIDED|95.0|-4.36|13.1||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to SP+MS with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in PDR was calculated as NER1006 rate - SP+MS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||13.10|-4.36|0.064
70894223|NCT02273141|141276602|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in PDR|2.95||||0.278|TWO_SIDED|95.0|-5.96|11.51||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to SP+MS with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in PDR was calculated as NER1006 rate - SP+MS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||11.51|-5.96|0.278
70894224|NCT00529399|141276621|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98|||||||ANCOVA|||"The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the AUC mean and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis."||||0.98
70894225|NCT00529399|141276621|SUPERIORITY_OR_OTHER_LEGACY|||||||0.51|||||||ANCOVA|||"The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the AUC mean and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis."||||0.51
70894226|NCT04313881|141276629|SUPERIORITY||Odds Ratio (OR)|0.876||||0.5218|TWO_SIDED|95.0|0.585|1.312||2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors (geographic region, cytogenetic risk status, and bone marrow blast percentage).|Cochran-Mantel-Haenszel|||||1.312|0.585|0.5218
70894227|NCT04313881|141276630|SUPERIORITY||Hazard Ratio (HR)|1.203||||0.1299|TWO_SIDED|95.0|0.947|1.528||2-sided P-value was based on stratified log-rank test, stratified by stratification factors.|Log Rank||Hazard ratio and its 95% confidence interval (CI) were calculated using the Cox proportional hazards regression model, stratified by stratification factors.|||1.528|0.947|0.1299
70894228|NCT04313881|141276632|SUPERIORITY||Odds Ratio (OR)|0.821||||0.2563|TWO_SIDED|95.0|0.584|1.155||2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors (geographic region, cytogenetic risk status, and bone marrow blast percentage).|Cochran-Mantel-Haenszel|||||1.155|0.584|0.2563
70894229|NCT04313881|141276634|SUPERIORITY||Odds Ratio (OR)|0.72||||0.2191|TWO_SIDED|95.0|0.427|1.212||95% CI for transfusion independence rate was based on Clopper-Pearson exact method. 2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors.|Cochran-Mantel-Haenszel|||||1.212|0.427|0.2191
70894230|NCT04313881|141276635|SUPERIORITY||Hazard Ratio (HR)|0.979||||0.8788|TWO_SIDED|95.0|0.746|1.285||2-sided P-value was based on stratified log-rank test, stratified by stratification factors.|Log Rank||Hazard ratio and its 95% CI were calculated using the Cox proportional hazards regression model, stratified by stratification factors.|||1.285|0.746|0.8788
70894231|NCT04313881|141276636|SUPERIORITY||Odds Ratio (OR)|0.441||||0.0375|TWO_SIDED|95.0|0.203|0.96||2-sided P-value, odds ratio and its 95% CI were based on unstratified Cochran-Mantel-Haenszel (CMH) method.|Cochran-Mantel-Haenszel||95% CI for response rate was based on Clopper-Pearson exact method.|||0.960|0.203|0.0375
70894232|NCT04313881|141276637|SUPERIORITY||Odds Ratio (OR)|0.947||||0.795|TWO_SIDED|95.0|0.629|1.426||2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors (geographic region, cytogenetic risk status, and bone marrow blast percentage).|Cochran-Mantel-Haenszel||95% CI for response rate was based on Clopper-Pearson exact method.|||1.426|0.629|0.7950
70894233|NCT04313881|141276638|SUPERIORITY||Hazard Ratio (HR)|0.837||||0.461|TWO_SIDED|95.0|0.522|1.343||2-sided P-value was based on stratified log-rank test, stratified by stratification factors.|Log Rank||Hazard ratio and its 95% CI were calculated using the Cox proportional hazards regression model, stratified by stratification factors.|||1.343|0.522|0.4610
70894234|NCT04313881|141276639|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.872|TWO_SIDED|95.0|0.802|1.297||2-sided P-value was based on stratified log-rank test, stratified by stratification factors (geographic region, cytogenetic risk status, and bone marrow blast percentage).|Log Rank||Hazard ratio and its 95% CI were calculated using the Cox proportional hazards regression model, stratified by stratification factors.|||1.297|0.802|0.8720
70894235|NCT04313881|141276640|SUPERIORITY|2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors|Odds Ratio (OR)|0.605||||0.0048|TWO_SIDED|95.0|0.428|0.857||2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors (geographic region, cytogenetic risk status, and bone marrow blast percentage).|Cochran-Mantel-Haenszel||95% CI for response rate was based on Clopper-Pearson exact method.|||0.857|0.428|0.0048
70894236|NCT02935062|141276644|SUPERIORITY|||||||0.001|||||||t-test, 1 sided|||||||0.001
70894237|NCT02935062|141276645|SUPERIORITY|||||||0.011|||||||t-test, 1 sided|||||||0.011
70894238|NCT01392560|141276673|SUPERIORITY_OR_OTHER||Mean change from baseline|-19.6|STANDARD_ERROR_OF_MEAN|5.6||0.0011|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test of the difference between baseline and end of treatment under euglycaemia condition for all patients||||0.0011
70894239|NCT01392560|141276673|SUPERIORITY_OR_OTHER||Mean change from baseline|-30.8|STANDARD_ERROR_OF_MEAN|6.2|<|0.0001|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test the difference between baseline and end of treatment under hyperglycaemia condition for all patients||||<0.0001
70894240|NCT01392560|141276673|SUPERIORITY_OR_OTHER||Change from baseline|-33.4|STANDARD_ERROR_OF_MEAN|6.2|<|0.0001|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test of the difference between baseline and end of treatment under euglycaemia condition for hyperfilterers||||<0.0001
70894241|NCT01392560|141276673|SUPERIORITY_OR_OTHER||Mean change from baseline|-44.5|STANDARD_ERROR_OF_MEAN|7.1|<|0.0001|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test of the difference between baseline and end of treatment under hyperglycaemia condition for hyperfilterers||||<0.0001
70894242|NCT01392560|141276673|SUPERIORITY_OR_OTHER||Mean change from baseline|9.0|STANDARD_ERROR_OF_MEAN|5.9||0.1524|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test of the difference between baseline and end of treatment under euglycaemia condition for non-hyperfilterers||||0.1524
70894243|NCT01392560|141276673|SUPERIORITY_OR_OTHER||Mean change from baseline|-2.4|STANDARD_ERROR_OF_MEAN|7.7||0.7585|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test of the difference between baseline and end of treatment under hyperglycaemia condition for non-filterers||||0.7585
70894244|NCT01329029|141276815|SUPERIORITY_OR_OTHER||Rate ratio|0.868|STANDARD_ERROR_OF_MEAN|0.0633||0.0529|TWO_SIDED|95.0|0.753|1.002||Level of significance: 5% 2-sided|Generalized Linear Regression|Poisson regression model (estimates of exacerbation rates using time in trial as model offset).|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|||1.002|0.753|0.0529
70894245|NCT01329029|141276816|SUPERIORITY_OR_OTHER||LS Mean difference|0.056|STANDARD_ERROR_OF_MEAN|0.0089|<|0.0001|TWO_SIDED|95.0|0.038|0.073|||ANCOVA|Analysis of Covariance (ANCOVA) including treatment by time interaction.||||0.073|0.038|<0.0001
70894246|NCT01329029|141276817|SUPERIORITY_OR_OTHER||Rate ratio|0.757|STANDARD_ERROR_OF_MEAN|0.0889||0.0175|TWO_SIDED|95.0|0.601|0.952|||Generalized Linear Regression|Analyzed using a negative binomial regression model excluding a correction for overdispersion.|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|||0.952|0.601|0.0175
70894247|NCT01329029|141276818|SUPERIORITY_OR_OTHER||Rate ratio|0.914|STANDARD_ERROR_OF_MEAN|0.0771||0.2875|TWO_SIDED|95.0|0.775|1.078||Level of significance: 5% 2-sided|Generalized Linear Regression|Poisson regression model (estimates of exacerbation rates using time in trial as model offset).|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|Moderate COPD Exacerbations||1.078|0.775|0.2875
70894248|NCT01329029|141276818|SUPERIORITY_OR_OTHER||Rate Ratio|0.794|STANDARD_ERROR_OF_MEAN|0.0654||0.005|TWO_SIDED|95.0|0.675|0.933||Level of significance: 5% 2-sided|Generalized Linear Regression|Poisson regression model (estimates of exacerbation rates using time in trial as model offset).|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|Mild, Moderate or Severe COPD Exacerbations||0.933|0.675|0.0050
70894249|NCT01329029|141276818|SUPERIORITY_OR_OTHER||Rate ratio|0.854|STANDARD_ERROR_OF_MEAN|0.0605||0.0262|TWO_SIDED|95.0|0.744|0.982||Level of significance: 5% 2-sided|Generalized Linear Regression|Poisson regression model (estimates of exacerbation rates using time in trial as model offset).|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|COPD Exacerbations treated with Glucocorticosteroids and/or Antibiotics||0.982|0.744|0.0262
70894250|NCT01329029|141276818|SUPERIORITY_OR_OTHER||Rate ratio|0.837|STANDARD_ERROR_OF_MEAN|0.0528||0.0047|TWO_SIDED|95.0|0.739|0.947||Level of significance: 5% 2-sided|Generalized Linear Regression|Poisson regression model (estimates of exacerbation rates using time in trial as model offset).|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|Moderate or Severe COPD Exacerbations and/or treated with Antibiotics||0.947|0.739|0.0047
70894251|NCT01329029|141276818|SUPERIORITY_OR_OTHER||Rate ratio|0.761|STANDARD_ERROR_OF_MEAN|0.0899||0.0209|TWO_SIDED|95.0|0.604|0.96||Level of significance: 5% 2-sided.|Generalized Linear Regression|Negative binomial regression model (estimates of exacerbation rates)|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|Leading to Hospitalisation||0.960|0.604|0.0209
70894252|NCT01329029|141276820|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.917|STANDARD_ERROR_OF_MEAN|0.0549||0.1461|TWO_SIDED|95.0|0.815|1.031||Level of significance: 5% 2-sided.|Cox proportional hazards model||A hazards ratio of \< 1 represents a lower hazard for the test treatment.|||1.031|0.815|0.1461
70894253|NCT01329029|141276821|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79|STANDARD_ERROR_OF_MEAN|0.0842||0.027|TWO_SIDED|95.0|0.641|0.974||Level of significance: 5% 2-sided|Wei-Lin-Weissfeld Method||A hazard ratio of \<1 represents a favourable outcome for the test treatment|||0.974|0.641|0.0270
70894254|NCT01329029|141276822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.749|STANDARD_ERROR_OF_MEAN|0.1209||0.0731|TWO_SIDED|95.0|0.546|1.027||Level of significance: 5% 2-sided|Wei-Lin-Weissfeld Method||A hazard ratio of \<1 represents a favourable outcome for the test treatment.|||1.027|0.546|0.0731
70894255|NCT01329029|141276823|SUPERIORITY_OR_OTHER||NNTB|9.0|||||TWO_SIDED|95.0|4.0|31.0||||||||31|4|
70894256|NCT01329029|141276826|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.092|STANDARD_ERROR_OF_MEAN|0.0159|<|0.0001|TWO_SIDED|95.0|0.061|0.124||Level of significance: 5% 2-sided.|Repeated measurement model|Unstructured covariance structure and restricted maximum likelihood (REML).||||0.124|0.061|<0.0001
70894257|NCT01329029|141276827|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.025|STANDARD_ERROR_OF_MEAN|0.0062|<|0.0001|TWO_SIDED|95.0|0.013|0.038||Level of significance: 5% 2-sided.|Repeated measurement model|Unstructured covariance structure and REML.||||0.038|0.013|<0.0001
70894258|NCT01329029|141276828|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.094|STANDARD_ERROR_OF_MEAN|0.0131|<|0.0001|TWO_SIDED|95.0|0.069|0.12||Level of significance: 5% 2-sided.|Repeated measurement model|Unstructured covariance structure and REML.||||0.120|0.069|<0.0001
70894259|NCT01329029|141276830|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.283|STANDARD_ERROR_OF_MEAN|0.0941||0.0027|TWO_SIDED|95.0|-0.467|-0.098||Level of significance: 5% 2-sided.|Repeated measurement model|Compound symmetry covariance structure and REML.||||-0.098|-0.467|0.0027
70894260|NCT01329029|141276831|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.015|STANDARD_ERROR_OF_MEAN|0.0439||0.7392|TWO_SIDED|95.0|-0.101|0.071||Level of significance: 5% 2-sided.|Repeated measurement model|Compound symmetry covariance structure and REML.||||0.071|-0.101|0.7392
70894261|NCT01329029|141276834|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.285|STANDARD_ERROR_OF_MEAN|0.2175||0.1909|TWO_SIDED|95.0|-0.711|0.142||Level of significance: 5% 2-sided.|Repeated measurement model|Unstructured covariance structure and REML.||||0.142|-0.711|0.1909
70894262|NCT01329029|141276836|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.025|STANDARD_ERROR_OF_MEAN|0.3468||0.9414|TWO_SIDED|95.0|0.528|1.99||Level of significance: 5% 2-sided.|Cox-proportional hazards model||A hazards ratio of \< 1 represents a lower hazard for the test treatment.|||1.990|0.528|0.9414
70894263|NCT01329029|141276837|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.078|STANDARD_ERROR_OF_MEAN|0.5765||0.8876|TWO_SIDED|95.0|0.378|3.075|||Cox-proportional hazards model|Level of significance: 5% 2-sided.|A hazards ratio of \< 1 represents a lower hazard for the test treatment.|||3.075|0.378|0.8876
70894264|NCT01329029|141276838|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.529|STANDARD_ERROR_OF_MEAN|0.1463|<|0.0001|TWO_SIDED|95.0|1.268|1.845|||Cox-proportional hazards model|Level of significance: 5% 2-sided.|A hazards ratio of \< 1 represents a lower hazard for the test treatment.|||1.845|1.268|<0.0001
70894265|NCT01329029|141276839|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.695|STANDARD_ERROR_OF_MEAN|0.2691||0.3477|TWO_SIDED|95.0|0.326|1.484||Level of significance: 5% 2-sided.|Cox-proportional hazards model||A hazards ratio of \< 1 represents a lower hazard for the test treatment.|||1.484|0.326|0.3477
70894266|NCT01329029|141276841|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.083|STANDARD_ERROR_OF_MEAN|0.3832||0.8208|TWO_SIDED|95.0|0.542|2.167||Level of significance: 5% 2-sided.|Cox-proportional hazards model||A hazards ratio of \< 1 represents a lower hazard for the test treatment.|||2.167|0.542|0.8208
70894267|NCT01329029|141276843|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.977|STANDARD_ERROR_OF_MEAN|0.0865||0.7943|TWO_SIDED|95.0|0.821|1.162||Level of significance: 5% 2-sided.|Cox-proportional hazards model|||||1.162|0.821|0.7943
70894268|NCT02621931|141276882|SUPERIORITY||LSM difference from placebo|-1.8|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-2.46|-1.15||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the statistical analysis plan (SAP).||-1.15|-2.46|<0.0001
70894269|NCT02621931|141276882|SUPERIORITY||LSM difference from placebo|-2.1|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-2.76|-1.45||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||-1.45|-2.76|<0.0001
70894270|NCT02621931|141276884|SUPERIORITY||LSM difference from placebo|-1.7|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|-2.48|-0.97||0.05 level of significance|ANCOVA|||||-0.97|-2.48|<0.0001
70894271|NCT02621931|141276884|SUPERIORITY||LSM difference from placebo|-1.8|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|-2.61|-1.09||0.05 level of significance|ANCOVA|||||-1.09|-2.61|<0.0001
70894272|NCT02621931|141276885|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 1: Active 675/placebo/placebo to Placebo||||<0.0001
70894273|NCT02621931|141276885|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 1: Active 675/225/225 to Placebo||||<0.0001
70894274|NCT02621931|141276885|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 2||||<0.0001
70894275|NCT02621931|141276885|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 2||||<0.0001
70894276|NCT02621931|141276885|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 3||||<0.0001
70894277|NCT02621931|141276885|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 3||||<0.0001
70894278|NCT02621931|141276885|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Overall||||<0.0001
70894279|NCT02621931|141276885|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Overall||||<0.0001
70894280|NCT02621931|141276886|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
70894281|NCT02621931|141276886|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
70894282|NCT02621931|141276887|SUPERIORITY||LSM difference from placebo|-2.3|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-2.95|-1.73||0.05 level of significance|ANCOVA|||||-1.73|-2.95|<0.0001
70894283|NCT02621931|141276888|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
70894284|NCT02621931|141276888|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
70894285|NCT02621931|141276889|SUPERIORITY|||||||0.0004||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||0.0004
70894286|NCT02621931|141276889|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
70894287|NCT04953390|141276919|OTHER|||||||0.004|||||||ANOVA|||||||0.004
70894288|NCT04953390|141276920|OTHER|||||||0.029|||||||ANOVA|||||||.029
70894289|NCT04953390|141276921|OTHER|||||||0.0002|||||||ANOVA|||||||0.0002
70894290|NCT04953390|141276922|OTHER|||||||0.14|||||||t-test, 2 sided|T-test done on DIR2 and DIR3 results only, as the conditions were equal for these two settings. DIR1 was tested in a different condition.||All three DIR settings were tested, but only the DIR2 and DIR3 were compared in t-test. This is because DIR1 mic setting was tested in a different condition (i.e. softer noise).||||.14
70894291|NCT04953390|141276925|OTHER|||||||0.0003|||||||ANOVA|||||||.0003
70894292|NCT05912400|141276926|OTHER||||||<|0.01||||||Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and NRS-11 Current (Numeric Pain Rating Scale for current pain).|Spearman's Rho|||||||<0.01
70894293|NCT05912400|141276926|OTHER|||||||0.02|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and NRS-11 Best (Numeric Pain Rating Scale for best pain).||||||0.02
70894294|NCT05912400|141276926|OTHER|||||||0.03|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and NRS-11 Worst (Numeric Pain Rating Scale for worst pain).||||||0.03
70894295|NCT05912400|141276926|OTHER|||||||0.88|||||||Spearman's Rho|Correlation: OCR (Oxygen Consumption Rate) and FACIT-F TOI (Functional Assessment of Chronic Illness Therapy - Fatigue, Trial Outcome Index)||||||0.88
70894296|NCT05912400|141276926|OTHER|||||||0.36|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and vitamin D levels.||||||0.36
70894297|NCT05912400|141276927|OTHER|||||||0.54|||||||Spearman's Rho|Spearman's rho used analyze correlation btwn ECAR (Extracellular Acidification Rate) and NRS-11 Current (Numeric Pain Rating Scale for current pain)||||||0.54
70894298|NCT05912400|141276927|OTHER|||||||0.36|||||||Spearman's Rho|Spearman's rho used to analyze correlation between ECAR (Extracellular Acidification Rate) and NRS-11 Best (Numeric Pain Rating Scale for best pain).||||||0.36
70894299|NCT05912400|141276927|OTHER|||||||0.94|||||||Spearman's Rho|Spearman's rho used to analyze correlation between ECAR (Extracellular Acidification Rate) \& NRS-11 Worst (Numeric Pain Rating Scale for worst pain).||||||0.94
70894300|NCT05912400|141276927|OTHER|||||||0.53|||||||Spearman's Rho|Correlation: ECAR (Extracellular Acidification Rate) \& FACIT-F TOI (Functional Assessment of Chronic Illness Therapy - Fatigue, Trial Outcome Index).||||||0.53
70894301|NCT05912400|141276927|OTHER|||||||0.51|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between ECAR (Extracellular Acidification Rate) and vitamin D levels.||||||0.51
70894302|NCT05912400|141276928|OTHER|||||||0.36|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and vitamin D levels.||||||0.36
70894303|NCT05912400|141276928|OTHER|||||||0.51|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between ECAR (Extracellular Acidification Rate) and vitamin D levels.||||||0.51
70894304|NCT05912400|141276929|OTHER||||||<|0.01|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and NRS-11 Current (Numeric Pain Rating Scale for current pain).||||||<0.01
70894305|NCT05912400|141276929|OTHER|||||||0.54|||||||Spearman's Rho|Spearman's rho used analyze correlation between ECAR (Extracellular Acidification Rate) \& NRS-11 Current (Numeric Pain Rating Scale for current pain).||||||0.54
70894306|NCT05912400|141276930|OTHER|||||||0.02|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and NRS-11 Best (Numeric Pain Rating Scale for best pain).||||||0.02
70894307|NCT05912400|141276930|OTHER|||||||0.36|||||||Spearman's Rho|Spearman's rho used to analyze correlation between ECAR (Extracellular Acidification Rate) and NRS-11 Best (Numeric Pain Rating Scale for best pain).||||||0.36
70894308|NCT05912400|141276931|OTHER|||||||0.03|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and NRS-11 Worst (Numeric Pain Rating Scale for worst pain).||||||0.03
70894309|NCT05912400|141276931|OTHER|||||||0.94|||||||Spearman's Rho|Spearman's rho used to analyze correlation between ECAR (Extracellular Acidification Rate) \& NRS-11 Worst (Numeric Pain Rating Scale for worst pain).||||||0.94
70894310|NCT05912400|141276932|OTHER|||||||0.88|||||||Spearman's Rho|Correlation: OCR (Oxygen Consumption Rate) and FACIT-F TOI (Functional Assessment of Chronic Illness Therapy - Fatigue, Trial Outcome Index).||||||0.88
70894311|NCT05912400|141276932|OTHER|||||||0.53|||||||Spearman's Rho|Correlation: ECAR (Extracellular Acidification Rate) \& FACIT-F TOI (Functional Assessment of Chronic Illness Therapy - Fatigue, Trial Outcome Index).||||||0.53
70894312|NCT03248739|141276935|EQUIVALENCE|Based on occlusion data from the previously referenced prospective study, as well as a P-value of 0.05 and power of 0.80, the study will need to include 90 patients to demonstrate statistical significance. To ensure that power is adequate, we will plan to enroll 120 patients (60 in each arm).||||||0.23|||||||Fisher Exact|||||||0.23
70894313|NCT04256733|141276949|SUPERIORITY|||||||0.23|||||||Mixed Models Analysis|||||||.23
70894314|NCT04256733|141276950|SUPERIORITY|||||||0.57|||||||Mixed Models Analysis|||||||.57
70894315|NCT04256733|141276951|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
70894316|NCT04542343|141276952|OTHER||Mean Difference (Net)|3.0|||<|0.01|TWO_SIDED|95.0|2.246|3.754|||t-test, 2 sided|||||3.75400|2.24600|<0.01
70894317|NCT04542343|141276953|OTHER||Mean Difference (Net)|-3.3|||<|0.001|TWO_SIDED|95.0|-4.256785|-2.343215|||t-test, 2 sided|||||-2.343215|-4.256785|<0.001
70894318|NCT04542343|141276958|OTHER||Mean Difference (Net)|-0.21818|||<|0.01|TWO_SIDED|95.0|-0.36828|-0.06809|||t-test, 2 sided|||||-0.06809|-0.36828|<0.01
70894319|NCT04542343|141276959|OTHER||Mean Difference (Net)|0.05623|STANDARD_ERROR_OF_MEAN|0.026|<|0.05|TWO_SIDED|95.0|0.00459|0.10788|||t-test, 2 sided|||||0.10788|0.00459|<0.05
70894320|NCT02566031|141276962|SUPERIORITY||Mean Difference (Net)|0.05||||0.0129|TWO_SIDED|95.0|0.011|0.093|||ANCOVA|||||0.093|0.011|0.0129
70894321|NCT02566031|141276963|SUPERIORITY||Mean Difference (Net)|0.06||||0.0058|TWO_SIDED|95.0|0.017|0.098|||ANCOVA|||-45 min||0.098|0.017|0.0058
70894322|NCT02566031|141276963|SUPERIORITY||Mean Difference (Net)|0.05||||0.0161|TWO_SIDED|95.0|0.009|0.091|||ANCOVA|||-15min||0.091|0.009|0.0161
70894323|NCT02566031|141276964|SUPERIORITY||Mean Difference (Net)|0.31||||0.0767|TWO_SIDED|95.0|-0.033|0.646|||ANCOVA|||||0.646|-0.033|0.0767
70894324|NCT02566031|141276965|SUPERIORITY||Mean Difference (Net)|-0.81||||0.1008|TWO_SIDED|95.0|-1.77|0.16|||ANCOVA|||||0.16|-1.77|0.1008
70894325|NCT02479412|141276976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02691|STANDARD_ERROR_OF_MEAN|0.05697||0.6379|TWO_SIDED|95.0|-0.08626|0.1401|||Mixed Models Analysis|||AZD7594 58 µg vs. PBO||0.1401|-0.08626|0.6379
70894326|NCT02479412|141276976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07604|STANDARD_ERROR_OF_MEAN|0.05663||0.1827|TWO_SIDED|95.0|-0.03645|0.1885|||Mixed Models Analysis|||AZD7594 250 µg vs.PBO||0.1885|-0.03645|0.1827
70894327|NCT02479412|141276976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1478|STANDARD_ERROR_OF_MEAN|0.05679||0.0108|TWO_SIDED|95.0|0.03494|0.2606|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||0.2606|0.03494|0.0108
70894328|NCT02479412|141276977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.857|STANDARD_ERROR_OF_MEAN|3.214||0.1342|TWO_SIDED|95.0|-11.24|1.528|||Mixed Models Analysis|||AZD7594 58 µg vs. PBO||1.528|-11.24|0.1342
70894329|NCT02479412|141276977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.41|STANDARD_ERROR_OF_MEAN|3.19||0.0016|TWO_SIDED|95.0|-16.75|-4.075|||Mixed Models Analysis|||AZD7594 250 µg vs. PBO||-4.075|-16.75|0.0016
70894330|NCT02479412|141276977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.75|STANDARD_ERROR_OF_MEAN|3.236|<|0.0001|TWO_SIDED|95.0|-21.18|-8.319|||Mixed Models Analysis|||AZD7594 800 µg vs. PBO||-8.319|-21.18|<0.0001
70894331|NCT02479412|141276978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.85|STANDARD_ERROR_OF_MEAN|5.139||0.0084|TWO_SIDED|95.0|-24.06|-3.642|||Mixed Models Analysis|||AZD7594 58 µg vs. PBO||-3.642|-24.06|0.0084
70894332|NCT02479412|141276978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.26|STANDARD_ERROR_OF_MEAN|5.088||0.0062|TWO_SIDED|95.0|-24.37|-4.149|||Mixed Models Analysis|||AZD7594 250 µg vs. PBO||-4.149|-24.37|0.0062
70894333|NCT02479412|141276978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.9|STANDARD_ERROR_OF_MEAN|5.137||0.0002|TWO_SIDED|95.0|-30.1|-9.689|||Mixed Models Analysis|||AZD7594 800 µg vs. PBO||-9.689|-30.10|0.0002
70894334|NCT02479412|141276979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03051|STANDARD_ERROR_OF_MEAN|0.05856||0.6036|TWO_SIDED|95.0|-0.08579|0.1468|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||0.1468|-0.08579|0.6036
70894335|NCT02479412|141276979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01744|STANDARD_ERROR_OF_MEAN|0.05869||0.767|TWO_SIDED|95.0|-0.09912|0.134|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.1340|-0.09912|0.7670
70894336|NCT02479412|141276979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1561|STANDARD_ERROR_OF_MEAN|0.05874||0.0093|TWO_SIDED|95.0|0.03943|0.2728|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||0.2728|0.03943|0.0093
70894337|NCT02479412|141276980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03467|STANDARD_ERROR_OF_MEAN|0.05377||0.5207|TWO_SIDED|95.0|-0.1415|0.07213|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||0.07213|-0.1415|0.5207
70894338|NCT02479412|141276980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02821|STANDARD_ERROR_OF_MEAN|0.05336||0.5983|TWO_SIDED|95.0|-0.07778|0.1342|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.1342|-0.07778|0.5983
70894339|NCT02479412|141276980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06169|STANDARD_ERROR_OF_MEAN|0.05371||0.2538|TWO_SIDED|95.0|-0.04501|0.1684|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||0.1684|-0.04501|0.2538
70894340|NCT02479412|141276981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02262|STANDARD_ERROR_OF_MEAN|0.05743||0.6945|TWO_SIDED|95.0|-0.1367|0.09144|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||0.09144|-0.1367|0.6945
70894341|NCT02479412|141276981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.000314|STANDARD_ERROR_OF_MEAN|0.05755||0.9957|TWO_SIDED|95.0|-0.1146|0.114|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.1140|-0.1146|0.9957
70894342|NCT02479412|141276981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06831|STANDARD_ERROR_OF_MEAN|0.05774||0.2398|TWO_SIDED|95.0|-0.04637|0.183|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||0.1830|-0.04637|0.2398
70894343|NCT02479412|141276982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.34|STANDARD_ERROR_OF_MEAN|5.877||0.0819|TWO_SIDED|95.0|-1.335|22.01|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||22.01|-1.335|0.0819
70894344|NCT02479412|141276982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.253|STANDARD_ERROR_OF_MEAN|5.881||0.3741|TWO_SIDED|95.0|-6.427|16.93|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||16.93|-6.427|0.3741
70894345|NCT02479412|141276982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.52|STANDARD_ERROR_OF_MEAN|5.926||0.0374|TWO_SIDED|95.0|0.7481|24.29|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||24.29|0.7481|0.0374
70894346|NCT02479412|141276983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.73|STANDARD_ERROR_OF_MEAN|5.384||0.0044|TWO_SIDED|95.0|5.039|26.43|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||26.43|5.039|0.0044
70894347|NCT02479412|141276983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.3|STANDARD_ERROR_OF_MEAN|5.419||0.0098|TWO_SIDED|95.0|3.534|25.06|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||25.06|3.534|0.0098
70894348|NCT02479412|141276983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.91|STANDARD_ERROR_OF_MEAN|5.459||0.0004|TWO_SIDED|95.0|9.068|30.75|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||30.75|9.068|0.0004
70894349|NCT02479412|141276984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3435|STANDARD_ERROR_OF_MEAN|0.189||0.0723|TWO_SIDED|95.0|-0.7189|0.03179|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||0.03179|-0.7189|0.0723
70894350|NCT02479412|141276984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4852|STANDARD_ERROR_OF_MEAN|0.1903||0.0124|TWO_SIDED|95.0|-0.8631|-0.1073|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||-0.1073|-0.8631|0.0124
70894351|NCT02479412|141276984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8026|STANDARD_ERROR_OF_MEAN|0.1914|<|0.0001|TWO_SIDED|95.0|-1.183|-0.4224|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||-0.4224|-1.183|<0.0001
70894352|NCT02479412|141276985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3071|STANDARD_ERROR_OF_MEAN|0.1051||0.0044|TWO_SIDED|95.0|-0.5159|-0.09836|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||-0.09836|-0.5159|0.0044
70894353|NCT02479412|141276985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1824|STANDARD_ERROR_OF_MEAN|0.1059||0.0883|TWO_SIDED|95.0|-0.3927|0.02789|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.02789|-0.3927|0.0883
70894354|NCT02479412|141276985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4301|STANDARD_ERROR_OF_MEAN|0.1055|<|0.0001|TWO_SIDED|95.0|-0.6397|-0.2205|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||-0.2205|-0.6397|<0.0001
70894355|NCT02479412|141276986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1651|STANDARD_ERROR_OF_MEAN|0.09139||0.0741|TWO_SIDED|95.0|-0.3466|0.01638|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||0.01638|-0.3466|0.0741
70894356|NCT02479412|141276986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09079|STANDARD_ERROR_OF_MEAN|0.09204||0.3265|TWO_SIDED|95.0|-0.2736|0.09201|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.09201|-0.2736|0.3265
70894357|NCT02479412|141276986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2532|STANDARD_ERROR_OF_MEAN|0.09176||0.007|TWO_SIDED|95.0|-0.4354|-0.07092|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||-0.07092|-0.4354|0.0070
70894358|NCT02479412|141276987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4185|STANDARD_ERROR_OF_MEAN|0.1626||0.0116|TWO_SIDED|95.0|-0.7414|-0.09563|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||-0.09563|-0.7414|0.0116
70894359|NCT02479412|141276987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1794|STANDARD_ERROR_OF_MEAN|0.1628||0.2732|TWO_SIDED|95.0|-0.5027|0.1438|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.1438|-0.5027|0.2732
70894360|NCT02479412|141276987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7661|STANDARD_ERROR_OF_MEAN|0.1636|<|0.0001|TWO_SIDED|95.0|-1.091|-0.4411|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||-0.4411|-1.091|<0.0001
70894361|NCT02479412|141276988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1067|STANDARD_ERROR_OF_MEAN|0.04982||0.0349|TWO_SIDED|95.0|-0.2057|-0.007755|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||-0.007755|-0.2057|0.0349
70894362|NCT02479412|141276988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08205|STANDARD_ERROR_OF_MEAN|0.05015||0.1052|TWO_SIDED|95.0|-0.1817|0.01756|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.01756|-0.1817|0.1052
70894363|NCT02479412|141276988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2027|STANDARD_ERROR_OF_MEAN|0.05044||0.0001|TWO_SIDED|95.0|-0.3028|-0.1025|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||-0.1025|-0.3028|0.0001
70894364|NCT02479412|141276989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.673|STANDARD_ERROR_OF_MEAN|0.2946||0.0247|TWO_SIDED|95.0|0.08779|1.258|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||1.258|0.08779|0.0247
70894365|NCT02479412|141276989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4281|STANDARD_ERROR_OF_MEAN|0.2965||0.1521|TWO_SIDED|95.0|-0.1607|1.017|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||1.017|-0.1607|0.1521
70894366|NCT02479412|141276989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9415|STANDARD_ERROR_OF_MEAN|0.2987||0.0022|TWO_SIDED|95.0|0.3483|1.535|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||1.535|0.3483|0.0022
70894367|NCT02479412|141276993|SUPERIORITY_OR_OTHER||Ratio Estimate (%)|272.2|||<|0.0001|TWO_SIDED|90.0|237.43|312.05|||ANOVA|||AZD7594 250 μg versus AZD7594 58 μg||312.05|237.43|<0.0001
70894368|NCT02479412|141276993|SUPERIORITY_OR_OTHER||Ratio Estimate (%)|676.13|||<|0.0001|TWO_SIDED|90.0|580.91|786.95|||ANOVA|||AZD7594 800 μg versus AZD7594 58 μg||786.95|580.91|<0.0001
70894369|NCT02479412|141276994|SUPERIORITY_OR_OTHER||Ratio Estimate (%)|337.82|||<|0.0001|TWO_SIDED|90.0|290.8|392.43|||ANOVA|||AZD7594 250 μg versus AZD7594 58 μg||392.43|290.80|<0.0001
70894370|NCT02479412|141276994|SUPERIORITY_OR_OTHER||Ratio Estimate (%)|964.62|||<|0.0001|TWO_SIDED|90.0|816.13|1140.13|||ANOVA|||AZD7594 800 μg versus AZD7594 58 μg||1140.13|816.13|<0.0001
70894371|NCT04969250|141277005|SUPERIORITY|||||||0.73|||||||Fisher Exact|||||||0.73
70894372|NCT04969250|141277006|SUPERIORITY|||||||0.4|||||||Fisher Exact|||||||0.40
70894373|NCT04969250|141277007|SUPERIORITY|||||||0.078|||||||Fisher Exact|||||||0.078
70894374|NCT04969250|141277008|SUPERIORITY|||||||0.033|||||||Fisher Exact|||||||0.033
70894375|NCT00574587|141277011|SUPERIORITY_OR_OTHER_LEGACY||95% Confidence interval|54.0|||<|0.1|TWO_SIDED|20.0|34.0|74.0|||Simon's Mimimax 2-stage design|||||74|34|<0.10
70894376|NCT04642638|141277015|OTHER||Difference in median|6.7|STANDARD_ERROR_OF_MEAN|3.35|||TWO_SIDED|95.0|0.0|6.7|||||Post-baseline change from baseline in IFN-gamma ELISpot response magnitudes was compared between groups using differences in medians and associated non-parametric 95% confidence interval (CI).|||6.70|0.00|
70894377|NCT04642638|141277015|OTHER||Difference in median|13.3|STANDARD_ERROR_OF_MEAN|10.55|||TWO_SIDED|95.0|3.3|17.8|||||Post-baseline change from baseline in IFN-gamma ELISpot response magnitudes was compared between groups using differences in medians and associated non-parametric 95% CI.|||17.80|3.30|
70894378|NCT04642638|141277015|OTHER||Difference in median|-6.6|STANDARD_ERROR_OF_MEAN|-5.0|||TWO_SIDED|95.0|-10.0|0.0|||||Post-baseline change from baseline in IFN-gamma ELISpot response magnitudes was compared between groups using differences in medians and associated non-parametric 95% CI.|||0.00|-10.00|
70894379|NCT04642638|141277016|OTHER||Geometric Mean Fold Rise (GMFR) Ratio|2.5|||||TWO_SIDED|95.0|1.72|3.632|||||95% CI of GMFR ratio is based on t-distribution, where GMFR ratio is based on the between-treatment-group comparisons.|||3.632|1.720|
70894380|NCT04642638|141277016|OTHER||GMFR Ratio|3.88|||||TWO_SIDED|95.0|2.638|5.7|||||95% CI of GMFR ratio is based on t-distribution, where GMFR ratio is based on the between-treatment-group comparisons.|||5.700|2.638|
70894381|NCT04642638|141277016|OTHER||GMFR Ratio|0.68|||||TWO_SIDED|95.0|0.512|0.893|||||95% CI of GMFR ratio is based on t-distribution, where GMFR ratio is based on the between-treatment-group comparisons|||0.893|0.512|
70894382|NCT00511004|141277031|SUPERIORITY_OR_OTHER||||||<|0.2|TWO_SIDED|||||Adjusted for multiple comparisons|Fisher Exact|||||||<0.2
70894383|NCT00511004|141277032|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Fisher Exact|||||||0.9
70894384|NCT02486328|141277060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
70894385|NCT02486328|141277061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
70894386|NCT02486328|141277062|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
70894387|NCT02486328|141277063|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
70894388|NCT02486328|141277064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
70894389|NCT02486328|141277065|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
70894390|NCT06242444|141277066|SUPERIORITY||Adjusted Mean Difference|8.35|STANDARD_ERROR_OF_MEAN|2.465||0.0012|TWO_SIDED|95.0|3.42|13.28|||Mixed Models Analysis||Adjusted mean difference was calculated as Test Dentifrice minus Placebo Control Dentifrice.|||13.28|3.42|0.0012
70894391|NCT06242444|141277067|SUPERIORITY||Adjusted Mean Difference|37.33|STANDARD_ERROR_OF_MEAN|3.217|<|0.0001|TWO_SIDED|95.0|30.9|43.76|||Mixed Models Analysis||Adjusted mean difference was calculated as Test Dentifrice minus Placebo Control Dentifrice.|||43.76|30.90|<.0001
70894392|NCT06242444|141277068|SUPERIORITY||Adjusted Mean Difference|3.95|STANDARD_ERROR_OF_MEAN|2.462||0.1138|TWO_SIDED|95.0|-0.97|8.87|||Mixed Models Analysis||Adjusted mean difference was calculated as Test Dentifrice minus Reference Dentifrice.|||8.87|-0.97|0.1138
70894393|NCT06242444|141277070|SUPERIORITY||Adjusted Mean Difference|2.22|STANDARD_ERROR_OF_MEAN|3.213||0.493|TWO_SIDED|95.0|-4.21|8.64|||Mixed Models Analysis||Adjusted mean difference was calculated as Test Dentifrice minus Reference Dentifrice.|||8.64|-4.21|0.4930
70894394|NCT06242444|141277074|SUPERIORITY||Adjusted Mean Difference|4.4|STANDARD_ERROR_OF_MEAN|2.462||0.0789|TWO_SIDED|95.0|-0.52|9.32|||Mixed Models Analysis||Adjusted mean difference was calculated as Reference Dentifrice minus Placebo Control Dentifrice.|At 4 hours of intra-oral exposure||9.32|-0.52|0.0789
70894395|NCT06242444|141277074|SUPERIORITY||Adjusted Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|2.408||0.2178|TWO_SIDED|95.0|-1.82|7.81|||Mixed Models Analysis||Adjusted mean difference was calculated as Reference Dentifrice minus Placebo Control Dentifrice.|At 12 hours of intra-oral exposure||7.81|-1.82|0.2178
70894396|NCT06242444|141277075|SUPERIORITY||Adjusted Mean Difference|35.12|STANDARD_ERROR_OF_MEAN|3.213|<|0.0001|TWO_SIDED|95.0|28.69|41.54|||Mixed Models Analysis||Adjusted mean difference was calculated as Reference Dentifrice minus Placebo Control Dentifrice.|At 4 hours of intra-oral exposure||41.54|28.69|<.0001
70894397|NCT06242444|141277075|SUPERIORITY||Adjusted Mean Difference|27.18|STANDARD_ERROR_OF_MEAN|3.018|<|0.0001|TWO_SIDED|95.0|21.14|33.21|||Mixed Models Analysis||Adjusted mean difference was calculated as Reference Dentifrice minus Placebo Control Dentifrice.|At 12 hours of intra-oral exposure||33.21|21.14|<.0001
70894398|NCT06242444|141277076|SUPERIORITY||Geometric Mean Ratio|1.73|||<|0.0001|TWO_SIDED|95.0|1.53|1.97|||Mixed Models Analysis|||At 4 hours of intra-oral exposure||1.97|1.53|<.0001
70894399|NCT06242444|141277076|SUPERIORITY||Geometric Mean Ratio|1.59|||<|0.0001|TWO_SIDED|95.0|1.42|1.78|||Mixed Models Analysis|||At 12 hours of intra-oral exposure||1.78|1.42|<.0001
70894400|NCT06242444|141277077|SUPERIORITY||Adjusted Mean Difference|0.307|STANDARD_ERROR_OF_MEAN|0.0277|<|0.0001|TWO_SIDED|95.0|0.252|0.362|||Mixed Models Analysis||Adjusted mean difference was calculated as Reference Dentifrice minus Placebo Control Dentifrice.|At 4 hours of intra-oral exposure||0.362|0.252|<.0001
70894401|NCT06242444|141277077|SUPERIORITY||Adjusted Mean Difference|0.242|STANDARD_ERROR_OF_MEAN|0.0257|<|0.0001|TWO_SIDED|95.0|0.19|0.293|||Mixed Models Analysis||Adjusted mean difference was calculated as Reference Dentifrice minus Placebo Control Dentifrice.|At 12 hours of intra-oral exposure||0.293|0.190|<.0001
70894402|NCT03317977|141277086|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||||||0.43
70894403|NCT00688636|141277134|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Fisher Exact|||||||.0005
70894404|NCT01572727|141277139|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.82|1.68||||||||1.68|0.82|
70894405|NCT04053764|141277147|SUPERIORITY||Odds Ratio (OR)|1.94|||||TWO_SIDED|95.0|0.53|7.14||||||||7.14|0.53|
70894406|NCT04053764|141277149|SUPERIORITY||Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.23|2.31||||||||2.31|0.23|
70894407|NCT04053764|141277150|SUPERIORITY||Odds Ratio (OR)|0.94|||||TWO_SIDED|95.0|0.29|3.02||||||PCR Improvement||3.02|0.29|
70894408|NCT04053764|141277150|SUPERIORITY||Odds Ratio (OR)|0.75|||||TWO_SIDED|95.0|0.18|3.2||||||Stable PCR||3.20|0.18|
70894409|NCT04053764|141277151|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|2.53|||TWO_SIDED|95.0|-5.53|4.65||||||From baseline to 3 months||4.65|-5.53|
70894410|NCT04053764|141277151|SUPERIORITY||Mean Difference (Final Values)|4.69|STANDARD_ERROR_OF_MEAN|3.32|||TWO_SIDED|95.0|-2.02|11.4||||||From baseline to 6 months||11.40|-2.02|
70894411|NCT04053764|141277151|SUPERIORITY||Mean Difference (Final Values)|4.05|STANDARD_ERROR_OF_MEAN|3.77|||TWO_SIDED|95.0|-3.58|11.68||||||From baseline to 9 months||11.68|-3.58|
70894412|NCT04053764|141277151|SUPERIORITY||Mean Difference (Final Values)|5.19|STANDARD_ERROR_OF_MEAN|4.17|||TWO_SIDED|95.0|-3.28|13.67||||||From baseline to 12 months||13.67|-3.28|
70894413|NCT04053764|141277154|SUPERIORITY||Odds Ratio (OR)|0.32|||||TWO_SIDED|95.0|0.09|1.21||||||||1.21|0.09|
70894414|NCT03998618|141277175|SUPERIORITY||partial correlation|0.12||||0.018|TWO_SIDED|95.0|-0.01|0.25||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 234. multiply imputed data were used in analyses.||||0.25|-0.01|.018
70894415|NCT03998618|141277176|SUPERIORITY||partial correlation|0.11||||0.037|TWO_SIDED|95.0|-0.02|0.24||P-value for study group x time interaction. Probabilities for the secondary outcomes were Sidak adjusted for correlated multiple outcomes (adjusted probability for significance = 0.0085).|Mixed Models Analysis|degrees of freedom = 234. Multiply imputed data were used.||||0.24|-0.02|.037
70894416|NCT03998618|141277177|SUPERIORITY||partial correlation|0.07||||0.355|TWO_SIDED|95.0|-0.06|0.2||P-value for study group x time interaction. Probabilities for the secondary outcomes were Sidak adjusted for correlated multiple outcomes (adjusted probability for significance = 0.0085).|Mixed Models Analysis|degrees of freedom = 234. Multiply imputed data were used.||||0.20|-0.06|.355
70894417|NCT03998618|141277178|SUPERIORITY||partial correlation|0.08||||0.167|TWO_SIDED|95.0|-0.04|0.21||P-value for study group x time interaction for physical quality of life. Probabilities for the secondary outcomes were Sidak adjusted for correlated multiple outcomes (adjusted probability for significance=0.0085).|Mixed Models Analysis|degrees of freedom = 234. Multiply imputed data were used.||||0.21|-0.04|.167
70894418|NCT03998618|141277178|SUPERIORITY||partial correlation|0.09||||0.105|TWO_SIDED|95.0|-0.03|0.22||P-value for study group x time interaction for social/family quality of life. Probabilities for the six secondary outcomes were Sidak adjusted for correlated multiple outcomes (adjusted probability for significance=0.0085).|Mixed Models Analysis|degrees of freedom = 234. Multiply imputed data were used.||||0.22|-0.03|.105
70894419|NCT03998618|141277178|SUPERIORITY||partial correlation|0.09||||0.142|TWO_SIDED|95.0|-0.04|0.22||P-value for study group x time interaction for emotional quality of life. Probabilities for the six secondary outcomes were Sidak adjusted for correlated multiple outcomes (adjusted probability for significance=0.0085).|Mixed Models Analysis|degrees of freedom = 234. Multiply imputed data were used.||||0.22|-0.04|.142
70894420|NCT03998618|141277178|SUPERIORITY||partial correlation|0.13||||0.006|TWO_SIDED|95.0|0.01|0.26||P-value for study group x time interaction for functional quality of life. Probabilities for the six secondary outcomes were Sidak adjusted for correlated multiple outcomes (adjusted probability for significance=0.0085).|Mixed Models Analysis|degrees of freedom = 234. Multiply imputed data were used.||||0.26|0.01|.006
70894421|NCT01968213|141277192|SUPERIORITY||Cox Proportional Hazard|0.365|||<|0.0001|TWO_SIDED|95.0|0.295|0.451|||Regression, Cox||||Analysis is performed by randomization strata of HRD classification by CTA, best response, and penultimate platinum progression-free interval.|0.451|0.295|<0.0001
70894422|NCT01968213|141277193|SUPERIORITY||Cox Proportional Hazard|0.354|||<|0.0001|TWO_SIDED|95.0|0.278|0.45|||Regression, Cox||||Analysis is performed by randomization strata of HRD classification by CTA, best response, and penultimate platinum progression-free interval.|0.450|0.278|<0.0001
70894423|NCT02558010|141277198|SUPERIORITY||||||<|0.05||||||The p-value was calculated, and does not indicate the threshold for statistical significance.|Mixed Models Analysis|||||||<0.05
70894424|NCT00295750|141277199|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit was -10 percentage points.|Difference in cumulative probability|1.9||||||97.5|-1.8|5.7||||||A non-inferiority assessment determined whether degarelix was non-inferior to leuprolide with respect to the cumulative probability of testosterone \<=0.5 ng/mL from Day 28 to Day 364.||5.7|-1.8|
70894425|NCT00295750|141277199|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit was -10 percentage points.|Difference in cumulative probability|0.9||||||97.5|-3.2|5.0||||||A non-inferiority assessment determined whether degarelix was non-inferior to leuprolide with respect to the cumulative probability of testosterone \<=0.5 ng/mL from Day 28 to Day 364.||5.0|-3.2|
70894426|NCT00295750|141277200|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
70894427|NCT00295750|141277200|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
70894428|NCT00295750|141277201|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
70894429|NCT00295750|141277201|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
70894430|NCT00295750|141277203|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Percentage change from baseline to Day 14||||<0.0001
70894431|NCT00295750|141277203|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Percentage change from baseline to Day 14||||<0.0001
70894432|NCT00295750|141277203|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Percentage change from baseline to Day 28||||<0.0001
70894433|NCT00295750|141277203|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Percentage change from baseline to Day 28||||<0.0001
70894434|NCT00295750|141277204|SUPERIORITY_OR_OTHER||Cumulative probability|85.8||||||95.0|79.8|90.1|||||95% confidence interval for the cumulative probability of completing the study without prostate specific antigen failure from Day 0 to Day 364.|||90.1|79.8|
70894435|NCT00295750|141277204|SUPERIORITY_OR_OTHER||Cumulative probability|91.1||||||95.0|85.9|94.5|||||95% confidence interval for the cumulative probability of completing the study without prostate specific antigen failure from Day 0 to Day 364.|||94.5|85.9|
70894436|NCT00295750|141277204|SUPERIORITY_OR_OTHER||Cumulative probability|85.9||||||95.0|79.9|90.2|||||95% confidence interval for the cumulative probability of completing the study without prostate specific antigen failure from Day 0 to Day 364.|||90.2|79.9|
70894437|NCT00936858|141277211|OTHER||6 month PFS probability|0.35|||||TWO_SIDED|||||||||We will declare the trial a success after observing 7 or more patients with PFS within 6 months. The study will have alpha = 0.092 and power =0.970, assuming a 6 month PFS probability of 0.12 for the null and a PFS probability of 0.35 as the alternative hypothesis.||||
70894438|NCT04403698|141277282|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||linear mixed models were used to compare bone turnover markers (CTX-I) between both treatment groups. These models were performed with an intention to treat approach, where drop-outs were considered as non-responders. The models accounted for repeated measures.||||<0.01
70894439|NCT04403698|141277283|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||linear mixed models were used to compare bone turnover markers (PINP) between both treatment groups. These models were performed with an intention to treat approach, where drop-outs were considered as non-responders. The models accounted for repeated measures.||||0.05
70894440|NCT04403698|141277284|SUPERIORITY|||||||0.042|||||||Fisher Exact|||A Fisher's exact test was used to assess differences in patient numbers exceeding reference ranges between both treatment groups at week 48||||0.042
70894441|NCT04403698|141277285|SUPERIORITY|||||||0.042|||||||Fisher Exact|||A Fisher's exact test was used to assess differences in patient numbers exceeding reference ranges between both treatment groups.||||0.042
70894442|NCT00567242|141277323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2801|STANDARD_ERROR_OF_MEAN|0.1077|<|0.05|ONE_SIDED|95.0||-0.0709|||t-test, 1 sided|||"H1: The Intention Group will show a significant rightward shift in lateral frontal laterality from pre-treatment to post-treatment.~H0: The Intention Group will show no shift in lateral frontal laterality from pre-treatment to post-treatment.~Since this is a repeated measures t test, the data are presented as the mean and standard deviation for for the post-treatment laterality index minus the pre-treatment laterality index."||-0.0709||<.05
70894443|NCT00567242|141277323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1832|STANDARD_ERROR_OF_MEAN|0.2768|<|0.05|ONE_SIDED|95.0||0.3546|||t-test, 1 sided|||"H1: The Control Group will show a significant rightward shift in lateral frontal lateral indices from pre-treatment to post-treatment.~H0: The Control group will show no shift in lateral frontal laterality indices from pre-treatment to post-treatment.~Since the analysis to test these hypotheses is a repeated-measures t-test, the mean and standard deviation are given for post-treatment laterality index minus pre-treatment laterality index."||0.3546||<.05
70894444|NCT00567242|141277324|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.88|<|0.05|ONE_SIDED|95.0|-1.81||||t-test, 1 sided|||"H1: The Intention Group would show more improvement across treatment than the Control Group.~H0: The Intention Group and the Control Group would not show any difference in improvement across treatment."|||-1.81|<.05
70894445|NCT00567242|141277325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.56|STANDARD_ERROR_OF_MEAN|0.73|<|0.05|ONE_SIDED|95.0|0.26||||t-test, 1 sided|||"H1: The Intention Group would show more improvement across treatment than the Control Group.~H0: The Intention Group and the Control Group would not show any difference in improvement across treatment."|||0.26|<.05
70894446|NCT03301051|141277361|OTHER|Vaccine Efficacy (VE) of VLP vaccine versus placebo = (1 - attack rate in vaccinated participants \[ARV\]/attack rate in unvaccinated participants \[ARU\]) x 100%.|Vaccine Efficacy|34.9|||||TWO_SIDED|95.0|17.6|48.6|||||The VE success criterion is defined as a \>40% lower limit of the two-sided 95% confidence interval (CI).|||48.6|17.6|
70894447|NCT03301051|141277362|OTHER|VE of VLP vaccine versus placebo = (1 - ARV/ARU) x 100%.|Vaccine Efficacy|38.6|||||TWO_SIDED|95.0|27.6|48.0|||||The VE success criterion is defined as a \>40% lower limit of the two-sided 95% CI.|||48.0|27.6|
70894448|NCT03301051|141277363|OTHER|VE of VLP vaccine versus placebo = (1 - ARV/ARU) x 100%.|Vaccine Efficacy|33.8|||||TWO_SIDED|95.0|14.9|48.5|||||The VE success criterion is defined as a \>40% lower limit of the two-sided 95% CI.|||48.5|14.9|
70894449|NCT03301051|141277364|OTHER|VE of VLP vaccine versus placebo = (1 - ARV/ARU) x 100%.|Vaccine Efficacy|37.6|||||TWO_SIDED|95.0|25.1|48.0|||||The VE success criterion is defined as a \>40% lower limit of the two-sided 95% CI.|||48.0|25.1|
70894450|NCT03301051|141277365|OTHER|VE of VLP vaccine versus placebo = (1 - ARV/ARU) x 100%.|Vaccine Efficacy|6.2|||||TWO_SIDED|95.0|0.8|11.3|||||The VE success criterion is defined as a \>40% lower limit of the two-sided 95% CI.|||11.3|0.8|
70894451|NCT00435370|141277391|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||||||<0.05
70894452|NCT00710424|141277428|SUPERIORITY_OR_OTHER_LEGACY||estimated treatment effect|-0.12||||0.634|TWO_SIDED|95.0|-0.6|0.36|||ANCOVA||A negative difference in treatment effect indicates an improvement in pain in favour of Sativex.|The model used for the analysis of the end of study value was an analysis of covariance (ANCOVA) with baseline value as a covariate and treatment group and centre group as main effect. The test was performed at the 10% significance level as a possible indicator of an interactive effect. The null hypothesis was one of no difference between treatments.||0.36|-0.60|0.634
70894453|NCT00710424|141277429|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.37|STANDARD_ERROR_OF_MEAN|2.153||0.865|TWO_SIDED|95.0|-3.87|4.61|||ANCOVA|||The change from baseline in mean neuropathic pain scale scale score at the end of treatment was to be compared between treatment groups using ANCOVA. The model was to include treatment and centre group as factors and baseline mean usage as a covariate.||4.61|-3.87|0.865
70894454|NCT00710424|141277430|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.45||||0.139|TWO_SIDED|95.0|-1.04|0.15|||ANCOVA|||The change from baseline in mean sleep quality numerical rating scale score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre group as factors and baseline mean usage as a covariate.||0.15|-1.04|0.139
70894455|NCT00710424|141277431|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.301||||0.219|TWO_SIDED|95.0|0.855|1.981|||Regression, Logistic|||In the analysis of Subject Global Impression of Change, the two treatment groups were compared using ordinal logistic regression and the proportional odds model. The model incorporated centre group as a factor.||1.981|0.855|0.219
70894456|NCT00710424|141277432|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|-0.05||||0.841|TWO_SIDED|95.0|-0.51|0.42|||ANCOVA|||The change from baseline in mean brief pain inventory (short form) composite score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre group as factors and baseline mean usage as a covariate.||0.42|-0.51|0.841
70894457|NCT00710424|141277433|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.021||0.523|TWO_SIDED|95.0|-0.06|0.03|||ANCOVA|||The change from baseline in weighted health state index score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre group as factors and baseline symptom score as a covariate.||0.03|-0.06|0.523
70894458|NCT00710424|141277434|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|-0.17||||0.41|TWO_SIDED|95.0|-0.59|0.24|||ANCOVA|||The model used for the analysis of the end of study value was ANCOVA with baseline value as a covariate and treatment group and centre group as main effect. The test was performed at the 10% significance level as a possible indicator of an interactive effect. The null hypothesis was one of no difference between treatments. A negative difference in adjusted means indicates an improvement in favour of Sativex.||0.24|-0.59|0.410
70894459|NCT00710424|141277437|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.857||||0.521|TWO_SIDED|95.0|0.537|1.37|||Regression, Logistic|||The numbers of responders were to be analysed using the difference in proportions and the odds ratio comparing the treatment groups with the provision of 95% CIs for the difference and odds ratio.||1.370|0.537|0.521
70894460|NCT01962493|141277438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.155||0.1313|TWO_SIDED|95.0|-0.51|0.1||Analysis based on square root transformation. Results back transformed for interpretation.|ANCOVA|Results were obtained from ANCOVA model with Site, Treatment, Treatment X Site, Smoking Status as fixed effects and baseline MLSI as a covariate.|Difference is first named treatment minus second named treatment. A negative difference favors the first named treatment|Null hypothesis stated that there was no difference between treatment groups||0.10|-0.51|0.1313
70894461|NCT04414696|141277451|SUPERIORITY||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-3.3|1.5|||||Multivariable linear regression|||1.5|-3.3|
70894462|NCT04414696|141277452|SUPERIORITY||Mean Difference (Final Values)|-4.5|||||TWO_SIDED|95.0|-23.5|14.5|||||Multivariable linear regression|||14.5|-23.5|
70894463|NCT04414696|141277453|SUPERIORITY||Mean Difference (Final Values)|3.8|||||TWO_SIDED|95.0|-1.9|9.5||||||||9.5|-1.9|
70894464|NCT04414696|141277454|SUPERIORITY||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-18.9|21.5|||||Multivariable linear regression|||21.5|-18.9|
70894465|NCT04414696|141277455|SUPERIORITY||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-3.7|1.1|||||Multivariable linear regression|||1.1|-3.7|
70894466|NCT04414696|141277456|SUPERIORITY||Mean Difference (Final Values)|-1.8|||||TWO_SIDED|95.0|-7.7|4.2|||||Multivariable linear regression|||4.2|-7.7|
70894467|NCT04414696|141277457|SUPERIORITY||Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-1.2|2.1|||||Multivariable linear regression|||2.1|-1.2|
70894468|NCT04414696|141277458|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-1.0|1.1|||||Multivariable linear regression|||1.1|-1|
70894469|NCT04414696|141277459|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-3.4|1.2|||||Multivariable linear regression|||1.2|-3.4|
70894470|NCT04414696|141277460|SUPERIORITY||Mean Difference (Final Values)|-1.8|||||TWO_SIDED|95.0|-4.9|1.3|||||Multivariable linear regression|||1.3|-4.9|
70894471|NCT02985866|141277471|SUPERIORITY|The first co-primary end point was superiority of CLC over SAP in terms of CGM-measured time below 70 mg/dL. The treatment groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect. Missing baseline data were handled by direct likelihood method. Model residuals were confirmed to be approximately normally distributed.|||||<|0.0001||||||To address the issue of multiple comparisons with 2 primary outcomes, the intervention was considered effective only if both co-primary outcomes were statistically significant at 5% level. P value for noninferiority NI (prespecified NI limit = 5%).|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Statistical analyses were performed on an intention-to-treat basis, and all participants with any amount of post randomization data were included in all analyses.||||<0.0001
70963633|NCT02499770|141432152|OTHER||||||=|0.0097||||||The p-value was calculated using the stratified log-rank test to account for the baseline ECOG status (0-1 vs 2) as the stratification factor. Significance level was set as two-sided 0.2.|Stratified log-rank test|p-value calculated using stratified log-rank test with baseline ECOG status (0-1 vs 2) as stratification factor. Significance level was two-sided 0.2.||||||= 0.0097
70894472|NCT02985866|141277472|NON_INFERIORITY|The second co-primary end point was noninferiority in CGM-measured time above 180 mg/dL, with a noninferiority limit of 5%. The treatment groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect. Missing baseline data were handled by direct likelihood method. Model residuals were confirmed to be approximately normally distributed.|||||<|0.0001||||||To address the issue of multiple comparisons with 2 primary outcomes, the intervention was considered effective only if both co-primary outcomes were statistically significant at 5% level. P value for noninferiority NI (prespecified NI limit = 5%).|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Statistical analyses were performed on an intention-to-treat basis, and all participants with any amount of post randomization data were included in all analyses.||||<0.0001
70894473|NCT02985866|141277473|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
70894474|NCT02985866|141277474|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
70894475|NCT02985866|141277475|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
70894476|NCT02985866|141277476|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
70894477|NCT02985866|141277477|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
70894478|NCT02985866|141277478|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
70894479|NCT02985866|141277479|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
70894480|NCT02008890|141277480|SUPERIORITY||Odds Ratio (OR)|1.33||||0.5722|TWO_SIDED|95.0|0.5|3.53|||Regression, Logistic|with factors treatment, country, body weight at baseline visit (\> 90 kg or \>= 90kg) and presence of plaque-type psoriasis||||3.53|0.50|0.5722
70894481|NCT02008890|141277480|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0411|TWO_SIDED|95.0|1.04|6.6|||Regression, Logistic|with factors treatment, country, body weight at baseline visit (\> 90 kg or \>= 90kg) and presence of plaque-type psoriasis||||6.60|1.04|0.0411
70894482|NCT02008890|141277481|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.9431|TWO_SIDED|95.0|-4.59|3.47|||Regression, Linear|with factors treatment, country, body weight at baseline visit (\> 90 kg or \>= 90kg) and presence of plaque-type psoriasis||||3.47|-4.59|0.9431
70894483|NCT02008890|141277481|SUPERIORITY||Mean Difference (Final Values)|-3.13||||0.1576|TWO_SIDED|95.0|-7.14|0.88|||Regression, Linear|with factors treatment, country, body weight at baseline visit (\> 90 kg or \>= 90kg) and presence of plaque-type psoriasis||||0.88|-7.14|0.1576
70894484|NCT02207816|141277488|SUPERIORITY||Vaccine efficacy|74.38||||0.2235|TWO_SIDED|95.0|-130.0|97.14|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||97.14|-130|0.2235
70894485|NCT02207816|141277488|SUPERIORITY||Vaccine efficacy|-9.57||||0.8972|TWO_SIDED|95.0|-339.0|72.64|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||72.64|-339|0.8972
70894486|NCT02207816|141277488|SUPERIORITY||Vaccine efficacy|30.58||||0.5333|TWO_SIDED|95.0|-119.0|78.0|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||78.00|-119|0.5333
70894487|NCT02207816|141277488|SUPERIORITY||Vaccine efficacy|44.2||||0.3523|TWO_SIDED|95.0|-90.9|83.69|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||83.69|-90.9|0.3523
70894488|NCT02207816|141277489|SUPERIORITY||Vaccine efficacy|53.68||||0.093|TWO_SIDED|95.0|-13.7|81.13|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||81.13|-13.7|0.0930
70894489|NCT02207816|141277489|SUPERIORITY||Vaccine efficacy|23.33||||0.5035|TWO_SIDED|95.0|-67.1|64.82|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||64.82|-67.1|0.5035
70894490|NCT02207816|141277489|SUPERIORITY||Vaccine efficacy|32.08||||0.3504|TWO_SIDED|95.0|-53.1|69.87|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||69.87|-53.1|0.3504
70894491|NCT02207816|141277489|SUPERIORITY||Vaccine efficacy|37.57||||0.2704|TWO_SIDED|95.0|-44.4|73.01|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||73.01|-44.4|0.2704
70894492|NCT02207816|141277490|SUPERIORITY||Vaccine efficacy|-5.26||||0.4434|TWO_SIDED|95.0|-20.0|7.69|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||7.69|-20.0|0.4434
70894493|NCT02207816|141277490|SUPERIORITY||Vaccine efficacy|-8.1||||0.2634|TWO_SIDED|95.0|-23.9|5.7|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||5.70|-23.9|0.2634
70894494|NCT02207816|141277490|SUPERIORITY||Vaccine efficacy|0.62||||0.9278|TWO_SIDED|95.0|-13.7|13.13|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||13.13|-13.7|0.9278
70894495|NCT02207816|141277490|SUPERIORITY||Vaccine efficacy|5.32||||0.4189|TWO_SIDED|95.0|-8.12|17.09|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||17.09|-8.12|0.4189
70894496|NCT02207816|141277491|SUPERIORITY||Vaccine efficacy|50.1||||0.1302|TWO_SIDED|95.0|-32.2|82.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).||82.90|-32.2|0.1302
70894497|NCT02207816|141277491|SUPERIORITY||Vaccine efficacy|16.9||||0.6897|TWO_SIDED|95.0|-96.9|65.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).||65.90|-96.9|0.6897
70894498|NCT02207816|141277491|SUPERIORITY||Vaccine efficacy|25.9||||0.5299|TWO_SIDED|95.0|-82.9|70.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).||70.90|-82.9|0.5299
70894499|NCT02207816|141277491|SUPERIORITY||Vaccine efficacy|25.4||||0.5307|TWO_SIDED|95.0|-84.1|70.7|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).||70.70|-84.1|0.5307
70894500|NCT02207816|141277492|SUPERIORITY||Vaccine efficacy|46.2||||0.1853|TWO_SIDED|95.0|-45.0|81.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).||81.80|-45.0|0.1853
70894501|NCT02207816|141277492|SUPERIORITY||Vaccine efficacy|35.0||||0.3828|TWO_SIDED|95.0|-69.3|76.6|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).||76.60|-69.3|0.3828
70894502|NCT02207816|141277492|SUPERIORITY||Vaccine efficacy|31.2||||0.4112|TWO_SIDED|95.0|-66.5|72.7|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).||72.70|-66.5|0.4112
70894503|NCT02207816|141277492|SUPERIORITY||Vaccine efficacy|30.8||||0.4121|TWO_SIDED|95.0|-67.6|72.5|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).||72.50|-67.6|0.4121
70894504|NCT02207816|141277493|SUPERIORITY||Vaccine efficacy|40.8|||<|0.0001|TWO_SIDED|95.0|15.7|58.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||58.80|15.70|<0.0001
70894505|NCT02207816|141277493|SUPERIORITY||Vaccine effiicacy|42.7|||<|0.0001|TWO_SIDED|95.0|17.4|60.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||60.80|17.40|<0.0001
70894506|NCT02207816|141277493|SUPERIORITY||Vaccine efficacy|16.0||||0.0883|TWO_SIDED|95.0|-6.6|33.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||33.90|-6.60|0.0883
70894507|NCT02207816|141277493|SUPERIORITY||Vaccine efficacy|13.0||||0.1889|TWO_SIDED|95.0|-10.7|31.7|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||31.70|-10.7|0.1889
70894508|NCT02207816|141277493|SUPERIORITY||Vaccine efficacy|16.4||||0.077|TWO_SIDED|95.0|-5.9|34.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||34.00|-5.90|0.0770
70894509|NCT02207816|141277493|SUPERIORITY||Vaccine efficacy|0.1||||1|TWO_SIDED|95.0|-25.8|20.7|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||20.70|-25.8|1.0000
70894510|NCT02207816|141277493|SUPERIORITY||Vaccine efficacy|20.8||||0.1624|TWO_SIDED|95.0|-17.5|46.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||46.90|-17.5|0.1624
70894511|NCT02207816|141277493|SUPERIORITY||Vaccine efficacy|-2.3||||0.9112|TWO_SIDED|95.0|-47.6|29.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||29.00|-47.6|0.9112
70894512|NCT02207816|141277493|SUPERIORITY||Vaccine efficacy|9.2||||0.4023|TWO_SIDED|95.0|-18.0|30.1|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||30.10|-18.0|0.4023
70894513|NCT02207816|141277493|SUPERIORITY||Vaccine efficacy|-4.4||||0.7091|TWO_SIDED|95.0|-34.5|18.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||18.90|-34.5|0.7091
70894514|NCT02207816|141277493|SUPERIORITY||Vaccine efficacy|-1.4||||0.9361|TWO_SIDED|95.0|-34.7|23.6|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||23.60|-34.7|0.9361
70894515|NCT02207816|141277493|SUPERIORITY||Vaccine efficacy|-6.8||||0.628|TWO_SIDED|95.0|-42.0|19.6|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||19.60|-42.0|0.6280
70894516|NCT02207816|141277494|SUPERIORITY||Vaccine efficacy|100.0||||0.4987|TWO_SIDED|95.0|-3779.0|100.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent severe anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||100.0|-3779|0.4987
70894517|NCT02207816|141277494|SUPERIORITY||Vaccine efficacy|100.0||||1|TWO_SIDED|95.0|-4051.0|100.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent severe anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||100.0|-4051|1.0000
70894518|NCT02207816|141277495|SUPERIORITY||Vaccine efficacy|-254.6||||0.1025|TWO_SIDED|95.0|-3399.0|32.5|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||32.50|-3399|0.1025
70894519|NCT02207816|141277495|SUPERIORITY||Vaccine efficacy|-398.6||||0.0284|TWO_SIDED|95.0|-4642.0|-3.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||-3.20|-4642|0.0284
70894520|NCT02207816|141277495|SUPERIORITY||Vaccine efficacy|36.7||||0.3543|TWO_SIDED|95.0|-78.8|79.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||79.20|-78.8|0.3543
70894521|NCT02207816|141277495|SUPERIORITY||Vaccine efficacy|3.2||||1|TWO_SIDED|95.0|-151.0|63.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||63.20|-151|1.0000
70894522|NCT02207816|141277495|SUPERIORITY||Vaccine efficacy|44.0||||0.3809|TWO_SIDED|95.0|-120.0|88.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||88.00|-120|0.3809
70894523|NCT02207816|141277495|SUPERIORITY||Vaccine efficacy|39.1||||0.549|TWO_SIDED|95.0|-140.0|86.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||86.90|-140|0.5490
70894524|NCT02207816|141277495|SUPERIORITY||Vaccine efficacy|-46.3||||0.3239|TWO_SIDED|95.0|-249.0|36.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||36.20|-249|0.3239
70894525|NCT02207816|141277495|SUPERIORITY||Vaccine efficacy|47.6||||0.2184|TWO_SIDED|95.0|-54.5|84.1|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||84.10|-54.5|0.2184
70894526|NCT02207816|141277495|SUPERIORITY||Vaccine efficacy|-116.8||||0.0724|TWO_SIDED|95.0|-476.0|10.3|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||10.30|-476|0.0724
70894527|NCT02207816|141277495|SUPERIORITY||Vaccine efficacy|-81.0||||0.2055|TWO_SIDED|95.0|-393.0|27.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||27.90|-393|0.2055
70894528|NCT02207816|141277495|SUPERIORITY||Vaccine efficacy|-18.4||||0.8138|TWO_SIDED|95.0|-245.0|57.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||57.90|-245|0.8138
70894529|NCT02207816|141277495|SUPERIORITY||Vaccine efficacy|24.4||||0.7887|TWO_SIDED|95.0|-148.0|78.4|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||78.40|-148|0.7887
70894530|NCT02207816|141277496|SUPERIORITY||Vaccine efficacy|40.5||||0.0077|TWO_SIDED|95.0|12.84|59.39|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||59.39|12.84|0.0077
70894531|NCT02207816|141277496|SUPERIORITY||Vaccine efficacy|-4.52||||0.7922|TWO_SIDED|95.0|-45.3|24.8|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||24.80|-45.3|0.7922
70894532|NCT02207816|141277496|SUPERIORITY||Vaccine efficacy|29.03||||0.0802|TWO_SIDED|95.0|-4.22|51.67|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||51.67|-4.22|0.0802
70894533|NCT02207816|141277496|SUPERIORITY||Vaccine efficacy|33.87||||0.0387|TWO_SIDED|95.0|2.13|55.32|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||55.32|2.13|0.0387
70894534|NCT02207816|141277497|SUPERIORITY||Vaccine efficacy|36.69||||0.0028|TWO_SIDED|95.0|14.6|53.07|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||53.07|14.60|0.0028
70894535|NCT02207816|141277497|SUPERIORITY||Vaccine efficacy|10.14||||0.443|TWO_SIDED|95.0|-18.1|31.64|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||31.64|-18.1|0.4430
70894536|NCT02207816|141277497|SUPERIORITY||Vaccine efficacy|30.99||||0.0245|TWO_SIDED|95.0|4.67|50.04|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||50.04|4.67|0.0245
70894537|NCT02207816|141277497|SUPERIORITY||Vaccine efficacy|34.24||||0.0122|TWO_SIDED|95.0|8.74|52.61|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||52.61|8.74|0.0122
70894538|NCT02207816|141277498|SUPERIORITY||Vaccine efficacy|23.67|||<|0.0001|TWO_SIDED|95.0|15.93|30.71|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||30.71|15.93|<.0001
70894539|NCT02207816|141277498|SUPERIORITY||Vaccine efficacy|19.15|||<|0.0001|TWO_SIDED|95.0|10.81|26.71|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||26.71|10.81|<.0001
70894540|NCT02207816|141277498|SUPERIORITY||Vaccine efficacy|15.55||||0.0009|TWO_SIDED|95.0|6.72|23.54|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||23.54|6.72|0.0009
70894541|NCT02207816|141277498|SUPERIORITY||Vaccine efficacy|13.15||||0.0056|TWO_SIDED|95.0|4.05|21.39|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||21.39|4.05|0.0056
70894542|NCT02207816|141277499|SUPERIORITY||Vaccine efficacy|35.5||||0.0053|TWO_SIDED|95.0|10.0|54.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||54.00|10.00|0.0053
70894543|NCT02207816|141277499|SUPERIORITY||Vaccine efficacy|11.7||||0.4255|TWO_SIDED|95.0|-20.0|35.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||35.20|-20.0|0.4255
70894544|NCT02207816|141277499|SUPERIORITY||Vaccine efficacy|29.2||||0.0479|TWO_SIDED|95.0|-2.4|51.4|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||51.40|-2.40|0.0479
70894545|NCT02207816|141277499|SUPERIORITY||Vaccine efficacy|18.1||||0.2346|TWO_SIDED|95.0|-16.9|42.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||42.80|-16.9|0.2346
70894546|NCT02207816|141277500|SUPERIORITY||Vaccine efficacy|35.9||||0.0051|TWO_SIDED|95.0|10.3|54.4|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||54.40|10.30|0.0051
70894547|NCT02207816|141277500|SUPERIORITY||Vaccine efficacy|14.0||||0.334|TWO_SIDED|95.0|-17.3|37.1|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||37.10|-17.3|0.3340
70894548|NCT02207816|141277500|SUPERIORITY||Vaccine efficacy|28.5||||0.0511|TWO_SIDED|95.0|-2.9|50.5|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Meenjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||50.50|-2.90|0.0511
70894549|NCT02207816|141277500|SUPERIORITY||Vaccine efficacy|20.3||||0.1729|TWO_SIDED|95.0|-13.5|44.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Meenjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||44.20|-13.5|0.1729
70894550|NCT02207816|141277503|SUPERIORITY||Vaccine efficacy|50.1||||0.6244|TWO_SIDED|95.0|-859.0|99.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).||99.20|-859|0.6244
70894551|NCT02207816|141277503|SUPERIORITY||Vaccine efficacy|-5.7||||1|TWO_SIDED|95.0|-1358.0|92.3|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).||92.30|-1358|1.0000
70894552|NCT02207816|141277503|SUPERIORITY||Vaccine efficacy|-188.9||||0.6244|TWO_SIDED|95.0|-15000.0|76.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).||76.80|-15000|0.6244
70894553|NCT02207816|141277503|SUPERIORITY||Vaccine efficacy|3.1||||1|TWO_SIDED|95.0|-7509.0|98.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).||98.80|-7509|1.0000
70894554|NCT02207816|141277504|SUPERIORITY||Vaccine efficacy|-98.8||||0.6869|TWO_SIDED|95.0|-2098.0|71.5|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||71.50|-2098|0.6869
70894555|NCT02207816|141277504|SUPERIORITY||Vaccine efficacy|-406.0||||0.0213|TWO_SIDED|95.0|-4650.0|-7.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||-7.80|-4650|0.0213
70894556|NCT02207816|141277505|SUPERIORITY||Vaccine efficacy|-98.8||||1|TWO_SIDED|95.0|-12000.0|89.6|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||89.60|-12000|1.0000
70894557|NCT02207816|141277505|SUPERIORITY||Vaccine efficacy|-304.8||||0.2154|TWO_SIDED|95.0|-20000.0|59.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||59.90|-20000|0.2154
70894558|NCT02207816|141277506|SUPERIORITY||Vaccine efficacy|-24.3||||1|TWO_SIDED|95.0|-526.0|73.3|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||73.30|-526|1.0000
70894559|NCT02207816|141277506|SUPERIORITY||Vaccine efficacy|-77.1||||0.3834|TWO_SIDED|95.0|-725.0|55.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||55.00|-725|0.3834
70894560|NCT02207816|141277506|SUPERIORITY||Vaccine efficacy|-297.5||||0.374|TWO_SIDED|95.0|-19000.0|60.7|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||60.70|-19000|0.3740
70894561|NCT02207816|141277506|SUPERIORITY||Vaccine efficacy|-498.1||||0.124|TWO_SIDED|95.0|-27000.0|27.4|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||27.40|-27000|0.1240
70894562|NCT00686166|141277511|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Exact binomal test|||||||0.18
70894563|NCT01217073|141277518|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.71|||<|0.001|TWO_SIDED|95.0|-0.93|-0.5||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-0.50|-0.93|<0.001
70894564|NCT01217073|141277518|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.67|||<|0.001|TWO_SIDED|95.0|-0.88|-0.45||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-0.45|-0.88|<0.001
70894565|NCT01217073|141277518|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.49|||<|0.001|TWO_SIDED|95.0|-0.7|-0.27||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-0.27|-0.70|<0.001
70894566|NCT01217073|141277518|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.5|||<|0.001|TWO_SIDED|95.0|-0.71|-0.28||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-0.28|-0.71|<0.001
70894567|NCT01217073|141277518|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.28||||0.012|TWO_SIDED|95.0|-0.5|-0.06||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-0.06|-0.50|0.012
70894568|NCT01217073|141277519|SUPERIORITY_OR_OTHER||Difference in percentage|6.2|||||TWO_SIDED|95.0|-6.2|18.4||||||||18.4|-6.2|
70894569|NCT01217073|141277519|SUPERIORITY_OR_OTHER||Difference in percentage|12.5|||||TWO_SIDED|95.0|-0.1|24.7||||||||24.7|-0.1|
70894570|NCT01217073|141277519|SUPERIORITY_OR_OTHER||Difference in percentage|5.9|||||TWO_SIDED|95.0|-6.5|18.0||||||||18.0|-6.5|
70894571|NCT01217073|141277519|SUPERIORITY_OR_OTHER||Difference in percentage|5.5|||||TWO_SIDED|95.0|-6.8|17.7||||||||17.7|-6.8|
70894572|NCT01217073|141277519|SUPERIORITY_OR_OTHER||Difference in percentage|2.4|||||TWO_SIDED|95.0|-9.8|14.5||||||||14.5|-9.8|
70894573|NCT01217073|141277520|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-4.1|4.1||||||||4.1|-4.1|
70894574|NCT01217073|141277520|SUPERIORITY_OR_OTHER||Difference in percentage|-0.9|||||TWO_SIDED|95.0|-4.9|2.4||||||||2.4|-4.9|
70894575|NCT01217073|141277520|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-4.1|4.0||||||||4.0|-4.1|
70894576|NCT01217073|141277520|SUPERIORITY_OR_OTHER||Difference in percentage|-0.9|||||TWO_SIDED|95.0|-4.9|2.4||||||||2.4|-4.9|
70894577|NCT01217073|141277520|SUPERIORITY_OR_OTHER||Difference in percentage|2.6|||||TWO_SIDED|95.0|-1.7|7.9||||||||7.9|-1.7|
70894578|NCT01217073|141277521|SUPERIORITY_OR_OTHER||Difference in percent|1.0|||||TWO_SIDED|95.0|-9.8|13.1||||||||13.1|-9.8|
70894579|NCT01217073|141277522|SUPERIORITY_OR_OTHER||Difference in percent|-1.4|||||TWO_SIDED|95.0|-9.1|2.6||||||||2.6|-9.1|
70894580|NCT01217073|141277523|SUPERIORITY_OR_OTHER||Difference in least squares mean|-44.9|||<|0.001|TWO_SIDED|95.0|-59.0|-30.7||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-30.7|-59.0|<0.001
70894581|NCT01217073|141277523|SUPERIORITY_OR_OTHER||Difference in least squares mean|-41.6|||<|0.001|TWO_SIDED|95.0|-55.3|-27.8||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-27.8|-55.3|<0.001
70894582|NCT01217073|141277523|SUPERIORITY_OR_OTHER||Difference in least squares mean|-35.1|||<|0.001|TWO_SIDED|95.0|-48.9|-21.3||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-21.3|-48.9|<0.001
70894583|NCT01217073|141277523|SUPERIORITY_OR_OTHER||Difference in least squares mean|-33.5|||<|0.001||95.0|-47.3|-19.7||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-19.7|-47.3|<0.001
70894584|NCT01217073|141277523|SUPERIORITY_OR_OTHER||Difference in least squares mean|-18.8||||0.009|TWO_SIDED|95.0|-32.9|-4.8||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-4.8|-32.9|0.009
70894585|NCT01217073|141277524|SUPERIORITY_OR_OTHER||Difference in least squares mean|-21.4|||<|0.001|TWO_SIDED|95.0|-29.4|-13.4||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-13.4|-29.4|<0.001
70894586|NCT01217073|141277524|SUPERIORITY_OR_OTHER||Difference in least squares mean|-13.5|||<|0.001|TWO_SIDED|95.0|-21.3|-5.7||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-5.7|-21.3|<0.001
70894587|NCT01217073|141277524|SUPERIORITY_OR_OTHER||Difference in least squares mean|-14.3|||<|0.001|TWO_SIDED|95.0|-22.2|-6.3||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-6.3|-22.2|<0.001
70894588|NCT01217073|141277524|SUPERIORITY_OR_OTHER||Difference in least squares mean|-19.0|||<|0.001|TWO_SIDED|95.0|-26.9|-11.2||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-11.2|-26.9|<0.001
70894589|NCT01217073|141277524|SUPERIORITY_OR_OTHER||Difference in least squares mean|-2.5||||0.539|TWO_SIDED|95.0|-10.4|5.5||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||5.5|-10.4|0.539
70894590|NCT00373334|141277565|SUPERIORITY_OR_OTHER|||||||0.528||95.0|||||Cochran-Mantel-Haenszel|||||||0.528
70894591|NCT00373334|141277565|SUPERIORITY_OR_OTHER|||||||0.341||95.0|||||Cochran-Mantel-Haenszel|||||||0.341
70894592|NCT00373334|141277566|SUPERIORITY_OR_OTHER|||||||0.746||95.0|||||Chi-squared|||Comparison of nizatidine 2.5 group to placebo group. P-value is for overall difference between groups (not comparison of individual categories).||||0.746
70894593|NCT00373334|141277566|SUPERIORITY_OR_OTHER|||||||0.262||95.0|||||Chi-squared|||Comparison of nizatidine 5.0 group to placebo group. P-value is for overall difference between groups (not comparison of individual categories).||||0.262
70894594|NCT00373334|141277567|SUPERIORITY_OR_OTHER|||||||0.609||95.0|||||Chi-squared|||Comparison of nizatidine 2.5 group to placebo group. P-value is for overall difference between groups (not comparison of individual categories).||||0.609
70894595|NCT00373334|141277567|SUPERIORITY_OR_OTHER|||||||0.938||95.0|||||Chi-squared|||Comparison of nizatidine 5.0 group to placebo group. P-value is for overall difference between groups (not comparison of individual categories).||||0.938
70894596|NCT01571362|141277670|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.62|STANDARD_ERROR_OF_MEAN|0.246||0.0114|TWO_SIDED|95.0|-1.11|-0.14||No adjustment was made for multiple comparisons. Statistical significance was if unadjusted p was less than or equal to (\<=) 0.05.|ANCOVA|||Null Hypothesis: No treatment difference. Power was 90%, 2-sided Alpha of 0.05, with assumed difference of 1 point and assumed standard deviation of 2.4 points.||-0.14|-1.11|0.0114
70894597|NCT01571362|141277671|SUPERIORITY_OR_OTHER||Difference of LS Means|0.18|STANDARD_ERROR_OF_MEAN|0.565||0.7547|TWO_SIDED|95.0|-0.94|1.29||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and Baseline score and final total daily dose of Titration Period as covariates.|ANCOVA|||||1.29|-0.94|0.7547
70894598|NCT01571362|141277672|SUPERIORITY_OR_OTHER|||||||0.1272|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) stratified by prior pain analgesic (opioid or non-opioid)||||||0.1272
70894599|NCT01571362|141277673|SUPERIORITY_OR_OTHER|||||||0.021|||||||Cochran-Mantel-Haenszel|CMH was stratified by prior pain analgesic (opioid and non-opioid).||||||0.0210
70894600|NCT01571362|141277674|SUPERIORITY_OR_OTHER|||||||0.0248|||||||Cochran-Mantel-Haenszel|The CMH test was stratified by prior pain analgesic (opioid or non-opioid).||||||0.0248
70894601|NCT01571362|141277675|SUPERIORITY_OR_OTHER|||||||0.009|||||||Cochran-Mantel-Haenszel|The CMH test was stratified by prior pain analgesic (opioid or non-opioid).||||||0.0090
70894602|NCT01571362|141277676|SUPERIORITY_OR_OTHER|||||||0.0874|||||||Cochran-Mantel-Haenszel|The CMH test was stratified by prior pain analgesic (opioid or non-opioid).||||||0.0874
70894603|NCT01571362|141277677|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Worst Pain Score||||<0.0001
70894604|NCT01571362|141277677|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Least Pain Score||||<0.0001
70894605|NCT01571362|141277677|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Average Pain Score||||<0.0001
70894606|NCT01571362|141277677|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Pain Right Now||||<0.0001
70894607|NCT01571362|141277677|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Pain Severity Index||||<0.0001
70894608|NCT01571362|141277677|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Pain Interference Index||||<0.0001
70894609|NCT01571362|141277678|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Worst Pain Score||||<0.0001
70894610|NCT01571362|141277678|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Least Pain Score||||<0.0001
70894611|NCT01571362|141277678|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Average Pain Score||||<0.0001
70894612|NCT01571362|141277678|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Pain Right Now||||<0.0001
70894613|NCT01571362|141277678|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Pain Severity Index||||<0.0001
70894614|NCT01571362|141277678|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Pain Interference Index||||<0.0001
70894615|NCT01571362|141277679|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.62|STANDARD_ERROR_OF_MEAN|0.222||0.0056|TWO_SIDED|95.0|-1.06|-0.18|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2.||-0.18|-1.06|0.0056
70894616|NCT01571362|141277679|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.243||0.009|TWO_SIDED|95.0|-1.12|-0.16|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4.||-0.16|-1.12|0.0090
70894617|NCT01571362|141277679|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.37|STANDARD_ERROR_OF_MEAN|0.271||0.1684|TWO_SIDED|95.0|-0.91|0.16|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.||0.16|-0.91|0.1684
70894618|NCT01571362|141277679|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.98|STANDARD_ERROR_OF_MEAN|0.244|<|0.0001|TWO_SIDED|95.0|-1.46|-0.5|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.||-0.50|-1.46|<0.0001
70894619|NCT01571362|141277680|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.4|STANDARD_ERROR_OF_MEAN|0.193||0.0412|TWO_SIDED|95.0|-0.78|-0.02|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2||-0.02|-0.78|0.0412
70894620|NCT01571362|141277680|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.87|STANDARD_ERROR_OF_MEAN|0.201|<|0.0001|TWO_SIDED|95.0|-1.27|-0.48|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4||-0.48|-1.27|<0.0001
70894621|NCT01571362|141277680|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.226||0.0055|TWO_SIDED|95.0|-1.08|-0.19|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.||-0.19|-1.08|0.0055
70894622|NCT01571362|141277680|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.86|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.27|-0.44|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.||-0.44|-1.27|<0.0001
70894623|NCT01571362|141277681|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.65|STANDARD_ERROR_OF_MEAN|0.19||0.0007|TWO_SIDED|95.0|-1.02|-0.27|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2.||-0.27|-1.02|0.0007
70894624|NCT01571362|141277681|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.74|STANDARD_ERROR_OF_MEAN|0.213||0.0006|TWO_SIDED|95.0|-1.16|-0.32|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4.||-0.32|-1.16|0.0006
70894625|NCT01571362|141277681|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.236||0.007|TWO_SIDED|95.0|-1.11|-0.18|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.||-0.18|-1.11|0.0070
70894626|NCT01571362|141277681|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.88|STANDARD_ERROR_OF_MEAN|0.221|<|0.0001|TWO_SIDED|95.0|-1.31|-0.44|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.||-0.44|-1.31|<0.0001
70894627|NCT01571362|141277682|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.207||0.0022|TWO_SIDED|95.0|-1.05|-0.23|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2.||-0.23|-1.05|0.0022
70894628|NCT01571362|141277682|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.79|STANDARD_ERROR_OF_MEAN|0.214||0.0003|TWO_SIDED|95.0|-1.21|-0.37|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4.||-0.37|-1.21|0.0003
70894629|NCT01571362|141277682|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.264||0.0078|TWO_SIDED|95.0|-1.23|-0.19|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.||-0.19|-1.23|0.0078
70894630|NCT01571362|141277682|SUPERIORITY_OR_OTHER||Difference of LS Means|-1.07|STANDARD_ERROR_OF_MEAN|0.231|<|0.0001|TWO_SIDED|95.0|-1.52|-0.62|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.||-0.62|-1.52|<0.0001
70894631|NCT01571362|141277683|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.58|STANDARD_ERROR_OF_MEAN|0.189||0.0022|TWO_SIDED|95.0|-0.95|-0.21|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2.||-0.21|-0.95|0.0022
70894632|NCT01571362|141277683|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.76|STANDARD_ERROR_OF_MEAN|0.198||0.0002|TWO_SIDED|95.0|-1.15|-0.37|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4.||-0.37|-1.15|0.0002
70894633|NCT01571362|141277683|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.61|STANDARD_ERROR_OF_MEAN|0.228||0.0078|TWO_SIDED|95.0|-1.06|-0.16|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.||-0.16|-1.06|0.0078
70894634|NCT01571362|141277683|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.95|STANDARD_ERROR_OF_MEAN|0.207|<|0.0001|TWO_SIDED|95.0|-1.35|-0.54|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.||-0.54|-1.35|<0.0001
70894635|NCT01571362|141277684|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.41|STANDARD_ERROR_OF_MEAN|0.188||0.0285|TWO_SIDED|95.0|-0.78|-0.04|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2.||-0.04|-0.78|0.0285
70894636|NCT01571362|141277684|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.188||0.0106|TWO_SIDED|95.0|-0.85|-0.11|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4.||-0.11|-0.85|0.0106
70894637|NCT01571362|141277684|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.17|STANDARD_ERROR_OF_MEAN|0.222||0.4529|TWO_SIDED|95.0|-0.6|0.27|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.||0.27|-0.60|0.4529
70894638|NCT01571362|141277684|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.65|STANDARD_ERROR_OF_MEAN|0.207||0.0018|TWO_SIDED|95.0|-1.06|-0.25|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.||-0.25|-1.06|0.0018
70894639|NCT01571362|141277685|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.258||0.0061|TWO_SIDED|95.0|-1.22|-0.2|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.||-0.20|-1.22|0.0061
70894640|NCT01571362|141277685|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.73|STANDARD_ERROR_OF_MEAN|0.277||0.0087|TWO_SIDED|95.0|-1.28|-0.19|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.||-0.19|-1.28|0.0087
70894641|NCT01571362|141277685|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.56|STANDARD_ERROR_OF_MEAN|0.315||0.0769|TWO_SIDED|95.0|-1.18|0.06|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.||0.06|-1.18|0.0769
70894642|NCT01571362|141277685|SUPERIORITY_OR_OTHER||Difference of LS Means|-1.1|STANDARD_ERROR_OF_MEAN|0.289||0.0002|TWO_SIDED|95.0|-1.67|-0.53|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/Early Termination.||-0.53|-1.67|0.0002
70894643|NCT01571362|141277686|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.224||0.025|TWO_SIDED|95.0|-0.95|-0.06|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.||-0.06|-0.95|0.0250
70894644|NCT01571362|141277686|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.89|STANDARD_ERROR_OF_MEAN|0.234||0.0002|TWO_SIDED|95.0|-1.36|-0.43|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.||-0.43|-1.36|0.0002
70894645|NCT01571362|141277686|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.77|STANDARD_ERROR_OF_MEAN|0.263||0.0038|TWO_SIDED|95.0|-1.29|-0.25|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.||-0.25|-1.29|0.0038
70894646|NCT01571362|141277686|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.98|STANDARD_ERROR_OF_MEAN|0.243|<|0.0001|TWO_SIDED|95.0|-1.46|-0.5|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/Early Termination.||-0.50|-1.46|<0.0001
70894647|NCT01571362|141277687|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.8|STANDARD_ERROR_OF_MEAN|0.214||0.0002|TWO_SIDED|95.0|-1.22|-0.38|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.||-0.38|-1.22|0.0002
70894648|NCT01571362|141277687|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.78|STANDARD_ERROR_OF_MEAN|0.235||0.001|TWO_SIDED|95.0|-1.25|-0.32|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.||-0.32|-1.25|0.0010
70894649|NCT01571362|141277687|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.79|STANDARD_ERROR_OF_MEAN|0.271||0.0041|TWO_SIDED|95.0|-1.32|-0.25|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.||-0.25|-1.32|0.0041
70894650|NCT01571362|141277687|SUPERIORITY_OR_OTHER||Difference of LS Means|-1.04|STANDARD_ERROR_OF_MEAN|0.245|<|0.0001|TWO_SIDED|95.0|-1.52|-0.56|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/Early Termination.||-0.56|-1.52|<0.0001
70894651|NCT01571362|141277688|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.6|STANDARD_ERROR_OF_MEAN|0.236||0.0115|TWO_SIDED|95.0|-1.06|-0.14|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.||-0.14|-1.06|0.0115
70894652|NCT01571362|141277688|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.66|STANDARD_ERROR_OF_MEAN|0.256||0.0099|TWO_SIDED|95.0|-1.17|-0.16|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.||-0.16|-1.17|0.0099
70894653|NCT01571362|141277688|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.307||0.0222|TWO_SIDED|95.0|-1.31|-0.1|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.||-0.10|-1.31|0.0222
70894654|NCT01571362|141277688|SUPERIORITY_OR_OTHER||Difference of LS Means|-1.02|STANDARD_ERROR_OF_MEAN|0.264||0.0001|TWO_SIDED|95.0|-1.54|-0.5|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/ Early Termination.||-0.50|-1.54|0.0001
70894655|NCT01571362|141277689|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.66|STANDARD_ERROR_OF_MEAN|0.218||0.0025|TWO_SIDED|95.0|-1.09|-0.24|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.||-0.24|-1.09|0.0025
70894656|NCT01571362|141277689|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.77|STANDARD_ERROR_OF_MEAN|0.235||0.0012|TWO_SIDED|95.0|-1.23|-0.31|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.||-0.31|-1.23|0.0012
70894657|NCT01571362|141277689|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.73|STANDARD_ERROR_OF_MEAN|0.272||0.0078|TWO_SIDED|95.0|-1.27|-0.19|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.||-0.19|-1.27|0.0078
70894658|NCT01571362|141277689|SUPERIORITY_OR_OTHER||Difference of LS Means|-1.04|STANDARD_ERROR_OF_MEAN|0.243|<|0.0001|TWO_SIDED|95.0|-1.52|-0.56|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/Early Termination.||-0.56|-1.52|<0.0001
70894659|NCT01571362|141277690|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.41|STANDARD_ERROR_OF_MEAN|0.228||0.0727|TWO_SIDED|95.0|-0.86|0.04|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.||0.04|-0.86|0.0727
70894660|NCT01571362|141277690|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.47|STANDARD_ERROR_OF_MEAN|0.238||0.0501|TWO_SIDED|95.0|-0.94|0.0|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.||0.00|-0.94|0.0501
70894661|NCT01571362|141277690|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.15|STANDARD_ERROR_OF_MEAN|0.262||0.5704|TWO_SIDED|95.0|-0.67|0.37|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.||0.37|-0.67|0.5704
70894662|NCT01571362|141277690|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.245||0.0096|TWO_SIDED|95.0|-1.12|-0.16|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/ Early Termination.||-0.16|-1.12|0.0096
70894663|NCT01571362|141277691|SUPERIORITY_OR_OTHER||Difference of LS Means|-27.75|STANDARD_ERROR_OF_MEAN|10.968||0.012|TWO_SIDED|95.0|-49.34|-6.16|||ANCOVA||Difference between treatment groups evaluated by ANCOVA with treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|||-6.16|-49.34|0.0120
70894664|NCT01571362|141277692|SUPERIORITY_OR_OTHER||Difference of LS Means|-3.87|STANDARD_ERROR_OF_MEAN|50.5||0.939|TWO_SIDED|95.0|-103.29|95.55|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the average daily rescue acetaminophen during the Titration Period and final total daily study medication dose of the Titration Period as covariates.|||95.55|-103.29|0.9390
70894665|NCT01571362|141277698|SUPERIORITY_OR_OTHER|||||||0.0014|||||||Wilcoxon test, survival analysis|P-value from Wilcoxon test with treatment and opioid stratum as factors||Time to 20% loss of analgesic response||||0.0014
70894666|NCT01571362|141277698|SUPERIORITY_OR_OTHER|||||||0.0024|||||||Wilcoxon test, survival analysis|P-value from Wilcoxon test with treatment and opioid stratum as factors||Time to 30% loss of analgesic response.||||0.0024
70894667|NCT01571362|141277698|SUPERIORITY_OR_OTHER|||||||0.0006|||||||Wilcoxon test, survival analysis|P-value from Wilcoxon test with treatment and opioid stratum as factors||Time to 40% loss of analgesic response.||||0.0006
70894668|NCT01571362|141277698|SUPERIORITY_OR_OTHER|||||||0.0021|||||||Wilcoxon test, survival analysis|P-value from Wilcoxon test with treatment and opioid stratum as factors||Time to 50% loss of analgesic response||||0.0021
70894669|NCT01571362|141277700|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon test, survival analysis|P-value from Wilcoxon test with treatment and opioid stratum as factors.||||||0.006
70894670|NCT01571362|141277710|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to the End of Open-Label Titration Period.||||<0.0001
70894671|NCT01571362|141277711|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline.||||<0.0001
70894672|NCT01571362|141277712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.05|STANDARD_ERROR_OF_MEAN|0.584||0.0733|TWO_SIDED|95.0|-2.2|0.1||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA|||Model-adjusted Change from Screening to Week 2.||0.10|-2.20|0.0733
70894673|NCT01571362|141277712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.642||0.2783|TWO_SIDED|95.0|-1.96|0.57||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA|||Model-adjusted Change from Screening to Week 4.||0.57|-1.96|0.2783
70894674|NCT01571362|141277712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58|STANDARD_ERROR_OF_MEAN|0.684||0.3951|TWO_SIDED|95.0|-0.77|1.93||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA|||Model-adjusted Change from Screening to Week 8.||1.93|-0.77|0.3951
70894675|NCT01571362|141277712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.614||0.9063|TWO_SIDED|95.0|-1.14|1.28||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA|||Model-adjusted Change from Screening to Week 12.||1.28|-1.14|0.9063
70894676|NCT01571362|141277713|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74|STANDARD_ERROR_OF_MEAN|0.463||0.1139|TWO_SIDED|95.0|-1.65|0.18||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Model-adjusted change from Baseline to Week 2.||0.18|-1.65|0.1139
70894677|NCT01571362|141277713|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.577||0.2264|TWO_SIDED|95.0|-1.84|0.44||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Model-adjusted Change from Baseline to Week 4.||0.44|-1.84|0.2264
70894678|NCT01571362|141277713|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41|STANDARD_ERROR_OF_MEAN|0.619||0.5074|TWO_SIDED|95.0|-0.81|1.63||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Model-adjusted Change from Baseline to Week 8.||1.63|-0.81|0.5074
70894679|NCT01571362|141277714|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Bowker's test of symmetry|||||||<0.0001
70894680|NCT01571362|141277715|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Bowker's test of symmetry|||||||<0.0001
70894681|NCT01571362|141277716|SUPERIORITY_OR_OTHER|||||||0.2211|||||||Cochran-Mantel-Haenszel|Stratified by opioid stratum.||||||0.2211
70894682|NCT01571362|141277717|SUPERIORITY_OR_OTHER|||||||0.5767|||||||Cochran-Mantel-Haenszel|Stratified by opioid stratum.||||||0.5767
70894683|NCT01571362|141277720|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Cochran-Mantel-Haenszel|Stratified by opioid stratum.||||||0.0004
70894684|NCT01571362|141277721|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Physical Functioning.||||<0.0001
70894685|NCT01571362|141277721|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Role-Physical.||||<0.0001
70894686|NCT01571362|141277721|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Bodily Pain.||||<0.0001
70894687|NCT01571362|141277721|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for General Health.||||<0.0001
70894688|NCT01571362|141277721|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Vitality.||||<0.0001
70894689|NCT01571362|141277721|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Social Functioning.||||<0.0001
70894690|NCT01571362|141277721|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Role-Emotional.||||<0.0001
70894691|NCT01571362|141277721|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Mental Health.||||<0.0001
70894692|NCT01571362|141277721|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Physical Component Score.||||<0.0001
70894693|NCT01571362|141277721|SUPERIORITY_OR_OTHER|||||||0.0026|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Mental Component Score.||||0.0026
70894694|NCT01571362|141277722|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, Mental Health, Physical Component Score, and Mental Component Score||||<0.0001
70894695|NCT01571362|141277723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.62|STANDARD_ERROR_OF_MEAN|0.952||0.5181|TWO_SIDED|95.0|-1.26|2.49||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Physical Functioning.||2.49|-1.26|0.5181
70894696|NCT01571362|141277723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.998||0.9733|TWO_SIDED|95.0|-2.0|1.93||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Role-Physical.||1.93|-2.00|0.9733
70894697|NCT01571362|141277723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.37|STANDARD_ERROR_OF_MEAN|0.914||0.01|TWO_SIDED|95.0|0.57|4.18||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Bodily Pain.||4.18|0.57|0.0100
70894698|NCT01571362|141277723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|0.764||0.4712|TWO_SIDED|95.0|-2.06|0.95||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for General Health Perceptions.||0.95|-2.06|0.4712
70894699|NCT01571362|141277723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.16|STANDARD_ERROR_OF_MEAN|1.091||0.2898|TWO_SIDED|95.0|-3.3|0.99||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Vitality.||0.99|-3.30|0.2898
70894700|NCT01571362|141277723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.48|STANDARD_ERROR_OF_MEAN|1.044||0.1565|TWO_SIDED|95.0|-0.57|3.54||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Social Functioning.||3.54|-0.57|0.1565
70894701|NCT01571362|141277723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.86|STANDARD_ERROR_OF_MEAN|1.348||0.522|TWO_SIDED|95.0|-3.52|1.79||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Role-Emotional.||1.79|-3.52|0.5220
70894702|NCT01571362|141277723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.995||0.9865|TWO_SIDED|95.0|-1.94|1.98||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Mental Health.||1.98|-1.94|0.9865
70894703|NCT01571362|141277723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.02|STANDARD_ERROR_OF_MEAN|0.885||0.2491|TWO_SIDED|95.0|-0.72|2.77||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Physical Component Score.||2.77|-0.72|0.2491
70894704|NCT01571362|141277723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.69|STANDARD_ERROR_OF_MEAN|1.073||0.5219|TWO_SIDED|95.0|-2.8|1.43||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Mental Component Score.||1.43|-2.80|0.5219
70894705|NCT01571362|141277724|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.52|STANDARD_ERROR_OF_MEAN|1.111||0.1731|TWO_SIDED|95.0|-0.67|3.71||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Physical Functioning.||3.71|-0.67|0.1731
70894706|NCT01571362|141277724|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|1.127||0.329|TWO_SIDED|95.0|-1.12|3.32||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Role-Physical.||3.32|-1.12|0.3290
70894707|NCT01571362|141277724|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.39|STANDARD_ERROR_OF_MEAN|1.047||0.0232|TWO_SIDED|95.0|0.33|4.45||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Bodily Pain.||4.45|0.33|0.0232
70894708|NCT01571362|141277724|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.858||0.8139|TWO_SIDED|95.0|-1.89|1.49||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for General Health Perceptions.||1.49|-1.89|0.8139
70894709|NCT01571362|141277724|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.45|STANDARD_ERROR_OF_MEAN|1.117||0.6878|TWO_SIDED|95.0|-2.65|1.75||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Vitality.||1.75|-2.65|0.6878
70894710|NCT01571362|141277724|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|STANDARD_ERROR_OF_MEAN|1.08||0.0658|TWO_SIDED|95.0|-0.13|4.12||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Social Functioning.||4.12|-0.13|0.0658
70894711|NCT01571362|141277724|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23|STANDARD_ERROR_OF_MEAN|1.374||0.867|TWO_SIDED|95.0|-2.48|2.94||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Role-Emotional.||2.94|-2.48|0.8670
70894712|NCT01571362|141277724|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|1.056||0.7259|TWO_SIDED|95.0|-1.71|2.45||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Mental Health.||2.45|-1.71|0.7259
70894713|NCT01571362|141277724|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.67|STANDARD_ERROR_OF_MEAN|1.007||0.0989|TWO_SIDED|95.0|-0.32|3.65||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Physical Component Score.||3.65|-0.32|0.0989
70894714|NCT01571362|141277724|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|1.142||0.9969|TWO_SIDED|95.0|-2.25|2.25||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Mental Component Score.||2.25|-2.25|0.9969
70894715|NCT01571362|141277725|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70894716|NCT01571362|141277726|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70894717|NCT01571362|141277727|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70894718|NCT01571362|141277728|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70894719|NCT01571362|141277729|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.032|STANDARD_ERROR_OF_MEAN|0.0168||0.0605|TWO_SIDED|95.0|-0.001|0.065||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of study drug during the Titration Period as covariates.|ANCOVA|||||0.065|-0.001|0.0605
70894720|NCT01571362|141277730|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.72|STANDARD_ERROR_OF_MEAN|1.999||0.7196|TWO_SIDED|95.0|-3.22|4.66||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors; Randomization Baseline score and final total daily dose of study drug during the Titration Period as covariates.|ANCOVA|||||4.66|-3.22|0.7196
70894721|NCT01571362|141277731|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.021|STANDARD_ERROR_OF_MEAN|0.0172||0.228|TWO_SIDED|95.0|-0.013|0.055||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA|||||0.055|-0.013|0.2280
70894722|NCT01571362|141277732|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.26|STANDARD_ERROR_OF_MEAN|2.048||0.2701|TWO_SIDED|95.0|-1.77|6.3||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA|||||6.30|-1.77|0.2701
70894723|NCT01571362|141277733|SUPERIORITY_OR_OTHER|||||||0.3822|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label for % Work Time Missed due to Low Back Pain.||||0.3822
70894724|NCT01571362|141277733|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label for % Impairment while Working due to Low Back Pain.||||<0.0001
70894725|NCT01571362|141277733|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label for % Overall Work Impairment due to Low Back Pain.||||<0.0001
70894726|NCT01571362|141277733|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label for % Activity Impairment due to Low Back Pain.||||<0.0001
70894727|NCT01571362|141277734|SUPERIORITY_OR_OTHER|||||||0.0017|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for % Work Time Missed due to Low Back Pain||||0.0017
70894728|NCT01571362|141277734|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for % Impairment while Working due to Low Back Pain||||<0.0001
70894729|NCT01571362|141277734|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for % Overall Work Impairment due to Low Back Pain||||<0.0001
70894730|NCT01571362|141277734|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for % Activity Impairment due to Low Back Pain||||<0.0001
70894731|NCT01571362|141277735|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.31|STANDARD_ERROR_OF_MEAN|2.883||0.1389|TWO_SIDED|95.0|-10.06|1.43||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 4||1.43|-10.06|0.1389
70894732|NCT01571362|141277735|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.88|STANDARD_ERROR_OF_MEAN|4.34||0.5094|TWO_SIDED|95.0|-11.56|5.8||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 8||5.80|-11.56|0.5094
70894733|NCT01571362|141277735|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.77|STANDARD_ERROR_OF_MEAN|4.043||0.4944|TWO_SIDED|95.0|-10.81|5.26||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 12/ET||5.26|-10.81|0.4944
70894734|NCT01571362|141277736|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.76|STANDARD_ERROR_OF_MEAN|4.295||0.1201|TWO_SIDED|95.0|-15.33|1.81||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 4||1.81|-15.33|0.1201
70894735|NCT01571362|141277736|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.99|STANDARD_ERROR_OF_MEAN|5.288||0.3497|TWO_SIDED|95.0|-15.6|5.62||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 8||5.62|-15.60|0.3497
70894736|NCT01571362|141277736|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.38|STANDARD_ERROR_OF_MEAN|4.532||0.6008|TWO_SIDED|95.0|-11.41|6.65||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 12/ET||6.65|-11.41|0.6008
70894737|NCT01571362|141277737|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.34|STANDARD_ERROR_OF_MEAN|4.986||0.1458|TWO_SIDED|95.0|-17.29|2.62||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 4||2.62|-17.29|0.1458
70894738|NCT01571362|141277737|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.35|STANDARD_ERROR_OF_MEAN|6.496||0.1558|TWO_SIDED|95.0|-22.38|3.68||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 8||3.68|-22.38|0.1558
70894739|NCT01571362|141277737|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.14|STANDARD_ERROR_OF_MEAN|5.582||0.3604|TWO_SIDED|95.0|-16.25|5.98||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 12/ET||5.98|-16.25|0.3604
70894740|NCT01571362|141277738|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.25|STANDARD_ERROR_OF_MEAN|2.389||0.0768|TWO_SIDED|95.0|-8.95|0.46||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 4||0.46|-8.95|0.0768
70894741|NCT01571362|141277738|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|2.684||0.7109|TWO_SIDED|95.0|-4.3|6.29||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 8||6.29|-4.30|0.7109
70894742|NCT01571362|141277738|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.15|STANDARD_ERROR_OF_MEAN|2.536||0.1031|TWO_SIDED|95.0|-9.14|0.85||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 12/ET||0.85|-9.14|0.1031
70894743|NCT01571362|141277739|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.73|STANDARD_ERROR_OF_MEAN|2.776||0.0926|TWO_SIDED|95.0|-10.26|0.8||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 4||0.80|-10.26|0.0926
70894744|NCT01571362|141277739|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.59|STANDARD_ERROR_OF_MEAN|3.414||0.6437|TWO_SIDED|95.0|-8.42|5.24||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 8||5.24|-8.42|0.6437
70894745|NCT01571362|141277739|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09|STANDARD_ERROR_OF_MEAN|3.391||0.748|TWO_SIDED|95.0|-7.84|5.65||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 12/ET||5.65|-7.84|0.7480
70894746|NCT01571362|141277740|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.38|STANDARD_ERROR_OF_MEAN|4.666||0.0098|TWO_SIDED|95.0|-21.68|-3.07||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 4||-3.07|-21.68|0.0098
70894747|NCT01571362|141277740|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.94|STANDARD_ERROR_OF_MEAN|5.336||0.0186|TWO_SIDED|95.0|-23.63|-2.25||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 8||-2.25|-23.63|0.0186
70894748|NCT01571362|141277740|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.2|STANDARD_ERROR_OF_MEAN|4.785||0.0581|TWO_SIDED|95.0|-18.72|0.32||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 12/ET||0.32|-18.72|0.0581
70894749|NCT01571362|141277741|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.56|STANDARD_ERROR_OF_MEAN|5.168||0.0177|TWO_SIDED|95.0|-22.87|-2.25||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 4||-2.25|-22.87|0.0177
70894750|NCT01571362|141277741|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.16|STANDARD_ERROR_OF_MEAN|5.998||0.0219|TWO_SIDED|95.0|-26.19|-2.14||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 8||-2.14|-26.19|0.0219
70894751|NCT01571362|141277741|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.35|STANDARD_ERROR_OF_MEAN|5.589||0.0679|TWO_SIDED|95.0|-21.47|0.78||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 12/ET||0.78|-21.47|0.0679
70894752|NCT01571362|141277742|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.5|STANDARD_ERROR_OF_MEAN|2.654||0.0052|TWO_SIDED|95.0|-12.72|-2.27||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 4||-2.27|-12.72|0.0052
70894753|NCT01571362|141277742|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.62|STANDARD_ERROR_OF_MEAN|2.999||0.1249|TWO_SIDED|95.0|-10.54|1.29||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 8||1.29|-10.54|0.1249
70894754|NCT01571362|141277742|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.19|STANDARD_ERROR_OF_MEAN|2.818||0.004|TWO_SIDED|95.0|-13.74|-2.64||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 12/ET||-2.64|-13.74|0.0040
70894755|NCT02071173|141277779|SUPERIORITY|Single group test comparison to a performance goal of 87%. Lower one-sided 97.5% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.|Percent|98.5|||||ONE_SIDED|97.5|97.0|||||||Ho: The Implant through 6-month lead-related complication-free rate ≤ 87%, Ha: The Implant through 6-month lead-related complication-free rate \> 87%|||97.0|
70894756|NCT02071173|141277780|SUPERIORITY|Single group test comparison to a performance goal of 85%. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.|Percent|96.5|||||ONE_SIDED|95.0|93.8|||||||Ho: The Implant through 6-month lead-related complication-free rate ≤ 85%, Ha: The Implant through 6-month lead-related complication-free rate \> 85%|||93.8|
70894757|NCT02071173|141277781|SUPERIORITY|Single group test comparison to a performance goal of 75%. Lower one-sided 97.5% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.|Percent|94.0|||||ONE_SIDED|97.5|92.0|||||||Ho: Percentage of PCT less than or equal to 2.5V ≤ 75%, Ha: Percentage of PCT less than or equal to 2.5V \> 75%|||92.0|
70894758|NCT02071173|141277782|SUPERIORITY|Single group test comparison to a performance goal of 75%. Lower one-sided 97.5% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.|Percent|91.1|||||ONE_SIDED|97.5|88.2|||||||Ho: Percentage of PCT less than or equal to 2.5V ≤ 75%, Ha: Percentage of PCT less than or equal to 2.5V \> 75%|||88.2|
70894759|NCT02071173|141277783|SUPERIORITY|Single group test comparison to a performance goal of 93%. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.|Percent|98.2|||||ONE_SIDED|95.0|97.5|||||||Ho: The Implant through 3-month lead-related complication-free rate ≤ 93%, Ha: The Implant through 3-month lead-related complication-free rate \> 93%|||97.5|
70894760|NCT02071173|141277784|SUPERIORITY|Single group test comparison to a performance goal of 94%. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.|Percent|99.3|||||ONE_SIDED|95.0|98.8|||||||Ho: The 3- through 24-month lead-related complication-free rate ≤ 94%, Ha: The 3- through 24-month lead-related complication-free rate \> 94%|||98.8|
70894761|NCT02071173|141277785|SUPERIORITY|Single group test comparison to a performance goal of 1.5 Volts. Upper one-sided 95% confidence limit was compared to the performance goal. If upper confidence limit was lower than the performance goal, null hypothesis was rejected.|Mean|0.56|||||ONE_SIDED|95.0||0.58||||||Ho: The 3-month mean PCT ≥ 1.5 Volts, Ha: The 3-month mean PCT \< 1.5 Volts||0.58||
70894762|NCT02071173|141277786|SUPERIORITY|Single group test comparison to a performance goal of 3 mV. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.|Mean|17.4|||||ONE_SIDED|95.0|16.7|||||||Ho: The 3-month mean sensed amplitude ≤ 3 mV, Ha: The 3-month mean sensed amplitude \> 3 mV|||16.7|
70894763|NCT02071173|141277787|SUPERIORITY|Single group test comparison to a performance goal of 3 mV. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.|Mean|16.1|||||ONE_SIDED|97.5|15.1|||||||Ho: The 3-month mean sensed amplitude ≤ 3 mV, Ha: The 3-month mean sensed amplitude \> 3 mV|||15.1|
70894764|NCT02071173|141277788|SUPERIORITY|Single group test comparison to a performance goal of 300 ohms. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.|Mean|776.0|||||ONE_SIDED|97.5|753.0|||||||Ho: The 3-month mean pacing impedance ≤ 300 ohms, Ha: The 3-month mean pacing impedance \> 300 ohms|||753|
70894765|NCT02071173|141277789|SUPERIORITY|Single group test comparison to a performance goal of 300 ohms. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.|Mean|805.0|||||ONE_SIDED|97.5|763.0|||||||Ho: The 3-month mean pacing impedance ≤ 300 ohms, Ha: The 3-month mean pacing impedance \> 300 ohms|||763|
70894766|NCT02071173|141277790|SUPERIORITY|Single group test comparison to a performance goal of 4.5 seconds. Upper one-sided 95% confidence limit was compared to the performance goal. If upper confidence limit was lower than the performance goal, null hypothesis was rejected.|Mean|3.14|||||ONE_SIDED|95.0||3.2||||||Ho: The mean detection time ≥ 4.5 seconds, Ha: The mean detection time \< 4.5 seconds||3.20||
70894767|NCT02071173|141277791|SUPERIORITY|Single group test comparison to a performance goal of 5 mV. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.|Mean|18.3|||||ONE_SIDED|95.0|6.2|||||||Ho: The 3-month mean sensed amplitude ≤ 5 mV, Ha: The 3-month mean sensed amplitude \> 5 mV|||6.2|
70894768|NCT02071173|141277792|OTHER|Two one-sided tests (TOST) were performed.|Mean|468.0|||||TWO_SIDED|90.0|463.0|472.0||||||Ho: Pacing impedance ≤ 300 Ω or pacing impedance ≥ 1200 Ω, Ha: 300 Ω \< Pacing impedance \< 1200 Ω||472|463|
70894769|NCT02071173|141277793|OTHER|Two one-sided tests (TOST) were performed.|Mean|702.0|||||TWO_SIDED|90.0|659.0|744.0||||||Ho: Pacing impedance ≤ 300 Ω or pacing impedance ≥ 1200 Ω, Ha: 300 Ω \< Pacing impedance \< 1200 Ω||744|659|
70894770|NCT02071173|141277794|SUPERIORITY|Single group test comparison to a performance goal of 93%. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.|Percent|99.5|||||ONE_SIDED|95.0|98.4|||||||Ho: Percent of successful conversion ≤ 93%, Ha: Percent of successful conversion \> 93%|||98.4|
70894771|NCT04118348|141277795|SUPERIORITY||Odds Ratio (OR)|5.73|||<|0.001|TWO_SIDED|95.0|4.46|7.36|||Regression, Logistic||BPA+HMT is the numerator|Passive control was set as the reference group.||7.36|4.46|<.001
70894772|NCT04118348|141277795|SUPERIORITY||Odds Ratio (OR)|4.87|||<|0.001|TWO_SIDED|95.0|3.79|6.27|||Regression, Logistic||BPA-only is the numerator|Passive control was set as the reference group.||6.27|3.79|<.001
70894773|NCT04118348|141277795|SUPERIORITY||Odds Ratio (OR)|1.67|||<|0.001|TWO_SIDED|95.0|1.28|2.19|||Regression, Logistic||HMT-only is the numerator|Passive control was set as the reference group.||2.19|1.28|<.001
70894774|NCT04118348|141277795|SUPERIORITY||Odds Ratio (OR)|3.43|||<|0.001|TWO_SIDED|95.0|2.73|4.29|||Regression, Logistic||BPA+HMT is the numerator|HMT was set as the reference group.||4.29|2.73|<.001
70894775|NCT04118348|141277795|SUPERIORITY||Odds Ratio (OR)|2.92|||<|0.001|TWO_SIDED|95.0|2.32|3.66|||Regression, Logistic||BPA-only is the numerator|HMT was set as the reference group.||3.66|2.32|<.001
70894776|NCT04118348|141277795|SUPERIORITY||Odds Ratio (OR)|1.17||||0.114|TWO_SIDED|95.0|0.96|1.43|||Regression, Logistic||BPA+HMT is the numerator|BPA was set as the reference group.||1.43|0.96|.114
70894777|NCT04118348|141277796|SUPERIORITY||Odds Ratio (OR)|2.9|||<|0.001|TWO_SIDED|95.0|2.02|4.15|||Regression, Logistic||BPA+HMT is the numerator|Passive control was set as the reference group.||4.15|2.02|<.001
70894778|NCT04118348|141277796|SUPERIORITY||Odds Ratio (OR)|2.28|||<|0.001|TWO_SIDED|95.0|1.57|3.3|||Regression, Logistic||BPA-only is the numerator|Passive control was set as the reference group.||3.30|1.57|<.001
70894779|NCT04118348|141277796|SUPERIORITY||Odds Ratio (OR)|1.54||||0.03|TWO_SIDED|95.0|1.04|2.27|||Regression, Logistic||HMT-only is the numerator|Passive control was set as the reference group.||2.27|1.04|.030
70894780|NCT04118348|141277796|SUPERIORITY||Odds Ratio (OR)|1.88|||<|0.001|TWO_SIDED|95.0|1.37|2.59|||Regression, Logistic||BPA+HMT is the numerator|HMT was set as the reference group.||2.59|1.37|<.001
70894781|NCT04118348|141277796|SUPERIORITY||Odds Ratio (OR)|1.48||||0.021|TWO_SIDED|95.0|1.06|2.06|||Regression, Logistic||BPA-only is the numerator|HMT was set as the reference group.||2.06|1.06|.021
70894782|NCT04118348|141277796|SUPERIORITY||Odds Ratio (OR)|1.27||||0.107|TWO_SIDED|95.0|0.95|1.71|||Regression, Logistic||BPA+HMT is the numerator|BPA was set as the reference group.||1.71|0.95|.107
70894783|NCT00121238|141277807|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.27
70894784|NCT02701985|141277851|OTHER||Difference in Response Rates|4.27||||0.7955|TWO_SIDED|95.0|-20.55|29.08|||Chi-square with Schouten Correction|||The proportion of patients who have ≥ 3 point reduction from baseline in ESSDAI score after 12 weeks of treatment was compared between the two treatment arms using a Pearson Chi-square test (two sided p-values, alpha 0.05). The difference in proportions and corresponding 95% confidence interval (CI) are provided. Patients with missing data at Week 12 will be treated as non-responders in the analysis.||29.08|-20.55|0.7955
70894785|NCT02701985|141277852|OTHER||Difference in Response Rates|1.14||||0.9877|TWO_SIDED|95.0|-23.92|26.19|||Chi-square with Schouten Correction|||The proportion of patients who have ≥ 1 point reduction from baseline in ESSPRI score after 12 weeks of treatment was compared between the two treatment arms using a Pearson Chi-square test (two sided p-values, alpha 0.05). The difference in proportions and corresponding 95% CI are provided. Patients with missing data at Week 12 will be treated as non-responders in the analysis.||26.19|-23.92|0.9877
70894786|NCT02701985|141277853|SUPERIORITY||Difference in Adjusted Means|-0.13||||0.8905|TWO_SIDED|95.0|-2.04|1.78|||Mixed Model for Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable.||1.78|-2.04|0.8905
70894787|NCT02701985|141277854|SUPERIORITY||Difference in Adjusted Means|-0.22||||0.6077|TWO_SIDED|95.0|-1.08|0.64|||Mixed Model of Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable.||0.64|-1.08|0.6077
70894788|NCT02701985|141277855|SUPERIORITY||Difference in Adjusted Means|-2.06||||0.2846||95.0|-5.87|1.75|||Mixed Model of Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable||1.75|-5.87|0.2846
70894789|NCT02701985|141277856|SUPERIORITY||Difference in Adjusted Means|-0.33||||0.8134||95.0|-2.43|3.08|||Mixed Model of Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable||3.08|-2.43|0.8134
70894790|NCT02701985|141277860|SUPERIORITY||Median Difference (Final Values)|0.87||||0.4266||95.0|-1.3|3.03|||Mixed Model of Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable.||3.03|-1.30|0.4266
70894791|NCT02701985|141277861|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.6429||95.0|-0.21|0.34|||Mixed Model of Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable.||0.34|-0.21|0.6429
70894792|NCT01640808|141277871|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.351|TWO_SIDED|95.0|0.72|1.124||A two-sided significance level was set at 0.05. Adjustment of multiplicity considering interim analysis is conducted by the Lan DeMets' method of α consumption function.|Log Rank|||||1.124|0.720|0.351
70894793|NCT01640808|141277872|SUPERIORITY||Hazard Ratio (HR)|0.875||||0.222|TWO_SIDED|95.0|0.706|1.085||A two-sided significance level was set at 0.05.|Log Rank|||||1.085|0.706|0.222
70894794|NCT01640808|141277873|SUPERIORITY||Hazard Ratio (HR)|0.882||||0.279|TWO_SIDED|95.0|0.703|1.108||A two-sided significance level was set at 0.05.|Log Rank|||||1.108|0.703|0.279
70894795|NCT04009291|141277878|SUPERIORITY||||||=|0.2635|||||||t-test, 2 sided|||Fisher's exact test is used to compare differences in the proportion of subjects meeting the composite primary endpoint in the TransCon PTH versus pooled placebo group||||= 0.2635
70894796|NCT04009291|141277878|SUPERIORITY||||||=|0.6999|||||||t-test, 2 sided|||Fisher's exact test is used to compare differences in the proportion of subjects meeting the composite primary endpoint in the TransCon PTH versus pooled placebo group||||= 0.6999
70894797|NCT04009291|141277878|SUPERIORITY||||||=|0.1394|||||||t-test, 2 sided|||Fisher's exact test is used to compare differences in the proportion of subjects meeting the composite primary endpoint in the TransCon PTH versus pooled placebo group||||= 0.1394
70894798|NCT04009291|141277879|SUPERIORITY||||||=|0.1281|||||||t-test, 2 sided|||Fisher's exact test is used to compare differences in the proportion of subjects meeting the composite primary endpoint in the TransCon PTH versus pooled placebo group||||= 0.1281
70894799|NCT04009291|141277879|SUPERIORITY||||||>|0.9999|||||||t-test, 2 sided|||Fisher's exact test is used to compare differences in the proportion of subjects meeting the composite primary endpoint in the TransCon PTH versus pooled placebo group||||> 0.9999
70894800|NCT04009291|141277879|SUPERIORITY||||||=|0.0604|||||||t-test, 2 sided|||Fisher's exact test is used to compare differences in the proportion of subjects meeting the composite primary endpoint in the TransCon PTH versus pooled placebo group||||= 0.0604
70894801|NCT02415400|141277913|NON_INFERIORITY|Non-Inferiority (NI) margin = 1.2|||||<|0.0001|||||||1-sided p-value for NI test|||Separate hierarchical testing was performed for apixaban vs VKA: 1) Non-inferiority for the primary endpoint.||||<0.0001
70894802|NCT02415400|141277913|SUPERIORITY||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.58|0.82|||2-sided p-value for superiority test|||Separate hierarchical testing was performed for apixaban vs VKA: 2) Superiority for the primary endpoint||0.82|0.58|<0.0001
70894803|NCT02415400|141277914|SUPERIORITY||Hazard Ratio (HR)|1.88|||<|0.0001|TWO_SIDED|95.0|1.58|2.23|||2-sided p-value for superiority test|||Separate hierarchical testing was performed for aspirin vs placebo: 2) Superiority for the primary endpoint.||2.23|1.58|<0.0001
70894804|NCT02415400|141277915|SUPERIORITY||||||<|0.0001|||||||2-sided p-value for superiority test|||Separate hierarchical testing was performed for apixaban vs VKA: 2) Superiority for the primary endpoint.||||<0.0001
70894805|NCT02415400|141277916|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0033|TWO_SIDED|95.0|0.75|0.94|||2-sided p-value|||Separate hierarchical testing was performed for apixaban vs VKA: 3) Superiority for all-cause death and all-cause rehospitalization.||0.94|0.75|0.0033
70894806|NCT02415400|141277917|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.2219|TWO_SIDED|95.0|0.96|1.2|||2-sided p-value|||Separate hierarchical testing was performed for aspirin vs placebo: 3) Superiority for all-cause death and all-cause rehospitalization.||1.20|0.96|0.2219
70894807|NCT02415400|141277918|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.437|TWO_SIDED|95.0|0.75|1.13|||2-sided p-value|||Separate hierarchical testing was performed for apixaban vs VKA: 4) Superiority for all-cause death and ischemic events.||1.13|0.75|0.4370
70894808|NCT02415400|141277919|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.1742|TWO_SIDED|95.0|0.7|1.07|||2-sided p-value|||Separate hierarchical testing was performed for aspirin vs placebo: 4) Superiority for all-cause death and ischemic events.||1.07|0.70|0.1742
70894809|NCT02270450|141277920|SUPERIORITY||Mean Difference (Net)|2.87|STANDARD_ERROR_OF_MEAN|4.3||0.5|TWO_SIDED|||||A p-value less than 0.05 is considered statistically significant.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|"A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the number of good days between patients assigned to surgery and patients assigned to non-surgical management."||||0.50
70894810|NCT02270450|141277921|SUPERIORITY||Mean Difference (Net)|-1.09||||0.64|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the length of the initial hospital stay between patients assigned to surgery and patients and patients assigned to non-surgical management. An interaction term between treatment and pathway was included.||||0.64
70894811|NCT02270450|141277922|SUPERIORITY||Odds Ratio (OR)|0.82||||0.6|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Logistic|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A parallel logistic regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares NG tube use vs no NG tube use between patients assigned to surgery and patients assigned to non-surgical management.||||0.60
70894812|NCT02270450|141277923|SUPERIORITY||Mean Difference (Net)|0.64||||0.47|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the number of days of NG tube use between patients assigned to surgery and patients and patients assigned to non-surgical management.||||0.47
70894813|NCT02270450|141277924|SUPERIORITY||Mean Difference (Net)|-4.1||||0.001|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for nausea severity between patients assigned to surgery and patients and patients assigned to non-surgical management. An interaction term between treatment and pathway was included.||||0.001
70894814|NCT02270450|141277924|SUPERIORITY||Mean Difference (Net)|-1.63||||0.008|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for vomiting severity between patients assigned to surgery and patients and patients assigned to non-surgical management.||||0.008
70894815|NCT02270450|141277924|SUPERIORITY||Mean Difference (Net)|-1.31||||0.04|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for bloating severity between patients assigned to surgery and patients and patients assigned to non-surgical management.||||0.04
70894816|NCT02270450|141277924|SUPERIORITY||Mean Difference (Net)|-3.6||||0.01|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for pain severity between patients assigned to surgery and patients and patients assigned to non-surgical management. An interaction term between treatment and pathway was included.||||0.01
70894817|NCT02270450|141277924|SUPERIORITY||Mean Difference (Net)|-1.9||||0.007|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for constipation severity between patients assigned to surgery and patients and patients assigned to non-surgical management.||||0.007
70894818|NCT02270450|141277925|SUPERIORITY||Odds Ratio (OR)|0.64||||0.52|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Logistic|Adjusted for treatment, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A parallel logistic regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares ability to eat between patients assigned to surgery and patients and patients assigned to non-surgical management.||||0.52
70894819|NCT02270450|141277926|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.12|TWO_SIDED|95.0|0.45|1.09|||Regression, Cox|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A Cox proportional hazards regression model stratified by pathway (randomized vs Patient Choice) was used to estimate the effect of treatment assignment (surgery vs non-surgical management) on overall survival.||1.09|0.45|0.12
70894820|NCT00617344|141278022|OTHER|The associated 95% confidence intervals (CIs) for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-2.0|||||TWO_SIDED|95.0|-7.44|2.84||||||Dengue Virus Serotype 1: Pre-injection 1 (Day 0)||2.84|-7.44|
70894821|NCT00617344|141278022|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-15.5|||||TWO_SIDED|95.0|-28.4|-2.0||||||Dengue Virus Serotype 1: 30 days post-injection 2||-2.00|-28.4|
70894822|NCT00617344|141278022|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-2.0|||||TWO_SIDED|95.0|-7.44|2.84||||||Dengue Virus Serotype 2: Pre-injection 1 (Day 0)||2.84|-7.44|
70894823|NCT00617344|141278022|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-3.1|||||TWO_SIDED|95.0|-15.0|8.75||||||Dengue Virus Serotype 2: 30 days post-injection 2||8.75|-15.0|
70894824|NCT00617344|141278022|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|1.0|||||TWO_SIDED|95.0|-9.09|11.1||||||Dengue Virus Serotype 3: Pre-injection 1 (Day 0)||11.1|-9.09|
70894825|NCT00617344|141278022|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-5.7|||||TWO_SIDED|95.0|-15.6|3.81||||||Dengue Virus Serotype 3: 30 days post-injection 2||3.81|-15.6|
70894826|NCT00617344|141278022|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-4.0|||||TWO_SIDED|95.0|-10.9|2.49||||||Dengue Virus Serotype 4: Pre-injection 1 (Day 0)||2.49|-10.9|
70894827|NCT00617344|141278022|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|31.4|||||TWO_SIDED|95.0|18.2|43.2||||||Dengue Virus Serotype 4: 30 days post-injection 2||43.2|18.2|
70894828|NCT02693665|141278051|SUPERIORITY|First measure of congruence was taken at 2 weeks post-baseline for controls, or immediately post-Session 2 for intervention dyads. Analysis presented here assessed differences between groups in agreement. This represents the underlying data without examining the pattern of congruence for each dyad over time. Longitudinal latent class analysis of congruence in responses over time between adolescents/families was conducted at the person not variable level.|Odds Ratio (OR)|3.22|||<|0.05|TWO_SIDED|95.0|1.09|9.57|||longitudinal latent class analysis|examined the pattern of change over time.||"Analysis was at the level of the dyad. AIM 1. To evaluate the efficacy of FACE-TC on patient-family congruence in treatment preferences.~H1a: FACE-TC participants will better maintain congruence over time, compared to controls.~H1b: Development of congruence may not be homogeneous and FACE-TC may influence the pattern of congruence development."||9.57|1.09|<0.05
70894829|NCT02693665|141278052|SUPERIORITY||Risk Ratio (RR)|1.00743162|||<|0.05|TWO_SIDED|95.0|0.928|1.094||The generalized mixed effect models are taking into account missingness by attrition. There were not missing values for the outcomes or predictors that we used.|Mixed Models Analysis|Model forced age, gender, race, family education, family income under the Federal Poverty level, on/off treatment.||Emotional distress-anxiety analysis at baseline comparing intervention and control.||1.094|0.928|<0.05
70894830|NCT02693665|141278052|SUPERIORITY||Risk Ratio (RR)|1.05037501|||<|0.05|TWO_SIDED|95.0|0.96438584|1.14403138||The generalized mixed effect models are taking into account missingness by attrition. There were not missing values for the outcomes or predictors that we used.|Mixed Models Analysis|Model forced age, gender, race, family education, family income under the Federal Poverty level, on/off treatment.||Emotional distress-anxiety analysis at 3 months post baseline comparing intervention and control. We hypothesized that anxiety would be lower in the intervention group compared to controls.||1.14403138|0.96438584|<0.05
70894831|NCT02693665|141278052|SUPERIORITY|See earlier comments.|Risk Ratio (RR)|1.01136067|||<|0.05|TWO_SIDED|95.0|0.92887892|1.10116656||See earlier comments.|t-test, 2 sided|See earlier comments.||This is analysis for 6 month outcomes of Emotional-distress - anxiety. See details in 3 month outcomes.||1.10116656|0.92887892|<0.05
70894832|NCT02693665|141278052|SUPERIORITY||Risk Ratio (RR)|1.14070431|||<|0.05|TWO_SIDED|95.0|1.04444724|1.2458325|||t-test, 2 sided||See earlier comments.|These are the 12 month outcomes for Emotional distress - anxiety. See earlier comments.||1.24583250|1.04444724|<0.05
70894833|NCT02693665|141278052|SUPERIORITY||Risk Ratio (RR)|0.98078271|||<|0.05|TWO_SIDED|95.0|0.89845609|1.07065301|||t-test, 2 sided|||This analysis is for the outcome Emotional distress - depressive symptoms. We hypothesized that adolescent in the intervention would have lower depressive symptoms compared to controls at 3, 6, and 12 month outcomes. The following are the baseline comparisons between control and intervention which were controlled for in the 3, 6, and 12 month analysis of outcomes.||1.07065301|0.89845609|<0.05
70894834|NCT02693665|141278052|SUPERIORITY||Risk Ratio (RR)|1.04007715|||<|0.05|TWO_SIDED|95.0|0.94970156|1.13905306|||t-test, 2 sided|||The results here are for the outcome variable Emotional Distress - Depressive symptoms at 3 month outcomes. We hypothesized that adolescents randomized to the intervention would have lower depressive symptoms than controls.||1.13905306|0.94970156|<0.05
70894835|NCT02693665|141278052|SUPERIORITY||Risk Ratio (RR)|1.07347088|||<|0.05|TWO_SIDED|95.0|0.9806271|1.17510491|||t-test, 2 sided|||We hypothesize that Emotional Distress - Depressive symptoms would be lower in intervention adolescents compared to controls at 6 months post intervention.||1.17510491|0.98062710|<0.05
70894836|NCT02693665|141278052|SUPERIORITY||Risk Ratio (RR)|1.11582434|||<|0.05|TWO_SIDED|95.0|1.01653156|1.22481585|||t-test, 2 sided|||We hypothesized that adolescents randomized to the intervention would have lower scores on Emotional Distress - Depressive symptoms compared to controls at 12 months post baseline.||1.22481585|1.01653156|<0.05
70894837|NCT02693665|141278052|SUPERIORITY||Risk Ratio, log|0.98803061|||<|0.05|TWO_SIDED|95.0|0.89065531|1.09605195|||t-test, 2 sided|||We hypothesized that adolescents randomized to the intervention would have no differences in fatigue at baseline if randomization was successful. In this analysis we examine the baseline results.||1.09605195|0.89065531|<0.05
70894838|NCT02693665|141278052|SUPERIORITY||Risk Ratio (RR)|1.13509797|||<|0.05|TWO_SIDED|95.0|1.01959639|1.26368376|||t-test, 2 sided|||We hypothesized that adolescents randomized to the intervention arm would report less Fatigue at 3 months outcome compared to controls.||1.26368376|1.01959639|<0.05
70894839|NCT02693665|141278052|SUPERIORITY||Risk Ratio (RR)|1.04944737|||<|0.05|TWO_SIDED|95.0|0.94281417|1.16814089|||t-test, 2 sided|||We hypothesized that adolescents randomized to the intervention would report less Fatigue at 6 months post baseline compared to control adolescents.||1.16814089|0.94281417|<0.05
70894840|NCT02693665|141278052|SUPERIORITY||Risk Ratio (RR)|1.11042568|||<|0.05|TWO_SIDED|95.0|0.99383841|1.24068981|||t-test, 2 sided|||We hypothesized that intervention adolescents would report less Fatigue than controls at 12 months post baseline.||1.24068981|0.99383841|<0.05
70894841|NCT02693665|141278052|SUPERIORITY||Risk Ratio (RR)|0.9683347|||<|0.05|TWO_SIDED|95.0|0.88658183|1.05762611|||t-test, 2 sided|||We hypothesized that there would be no differences at baseline between intervention and control adolescents with respect to Pain Interference.||1.05762611|0.88658183|<0.05
70894842|NCT02693665|141278052|SUPERIORITY||Risk Ratio (RR)|1.04450374|||<|0.05|TWO_SIDED|95.0|0.95307464|1.1447037|||t-test, 2 sided|||We hypothesized that adolescents randomized to the intervention compared to controls would report less Pain Interference at 3 months post baseline.||1.14470370|0.95307464|<0.05
70894843|NCT02693665|141278052|SUPERIORITY||Risk Ratio (RR)|1.07182133|||<|0.05|TWO_SIDED|95.0|0.97835451|1.17421748|||t-test, 2 sided|||We hypothesized that adolescents randomized to the intervention compared to controls would report less Pain Interference at 6 months post baseline.||1.17421748|0.97835451|<0.05
70894844|NCT02693665|141278052|SUPERIORITY||Risk Ratio, log|1.09964781|||<|0.05|TWO_SIDED|95.0|1.00051223|1.20860622|||t-test, 2 sided|||We hypothesized that at 12 month outcome adolescents randomized to the intervention would report less Pain Interference compared to control adolescents.||1.20860622|1.00051223|<0.05
70894845|NCT02693665|141278053|SUPERIORITY||Mean ratio|0.98|||<|0.05|TWO_SIDED|95.0|0.88|1.09|||Mixed Models Analysis|||Meaning and Peace Subscale at 3 months post intervention||1.09|0.88|<0.05
70894846|NCT02693665|141278053|SUPERIORITY||Mean ratio|0.97|||<|0.05|TWO_SIDED|95.0|0.88|1.08|||Mixed Models Analysis|||Meaning and Peace subscale at 6 months post intervention||1.08|0.88|<0.05
70894847|NCT02693665|141278053|SUPERIORITY||Mean ratio|0.92|||<|0.05|TWO_SIDED|95.0|0.82|1.02|||Mixed Models Analysis|||Meaning and Peace subscale at 12 months post intervention||1.02|0.82|<0.05
70894848|NCT02693665|141278053|SUPERIORITY||Mean ratio|0.92|||<|0.05|TWO_SIDED|95.0|0.73|1.16|||Mixed Models Analysis|||Faith subscale score at 3 months post intervention||1.16|0.73|<0.05
70894849|NCT02693665|141278053|SUPERIORITY||Mean ratio|0.96|||<|0.05|TWO_SIDED|95.0|0.76|1.21|||Mixed Models Analysis|||Faith subscale at 6 months post intervention||1.21|0.76|<0.05
70894850|NCT02693665|141278053|SUPERIORITY||Mean ratio|0.92|||<|0.05|TWO_SIDED|95.0|0.72|1.17|||Mixed Models Analysis|||Faith subscale scores at 12 months post intervention||1.17|0.72|<0.05
70894851|NCT02693665|141278054|SUPERIORITY||Mean Difference (Final Values)|-0.14|||<|0.05|TWO_SIDED|95.0|-0.42|0.15|||GEE model|||Caregiver Strain subscale at 3 months post-intervention comparing intervention to TAU, controlling for baseline levels.||0.15|-0.42|<0.05
70894852|NCT02693665|141278054|SUPERIORITY||Mean Difference (Final Values)|0.19|||<|0.05|TWO_SIDED|95.0|0.02|0.36|||GEE model|||Positive Caregiving Appraisal subscale at 3 months post-intervention comparing intervention to TAU, controlling for baseline levels.||0.36|0.02|<0.05
70894853|NCT02693665|141278054|SUPERIORITY||Mean Difference (Final Values)|-0.01|||<|0.05|TWO_SIDED|95.0|-0.35|0.32|||GEE model|||Caregiver Distress subscale at 3 months post-intervention comparing intervention to TAU, controlling for baseline levels.||0.32|-0.35|<0.05
70894854|NCT02693665|141278054|SUPERIORITY||Mean Difference (Final Values)|0.16|||<|0.05|TWO_SIDED|95.0|-0.07|0.38|||GEE model|||Family Well-Being subscale at 3 months post-intervention, comparing intervention to TAU, controlling for baseline levels.||0.38|-0.07|<0.05
70894855|NCT02693665|141278056|SUPERIORITY||Slope|0.44|STANDARD_ERROR_OF_MEAN|0.59||0.47|TWO_SIDED||||||Regression, Linear|Intervention effect for quality of adolescent communication score controlling for age, gender, race, income and on active treatment.|It is the standard error of the slope, but this was not an option.|Quality of communication analysis for adolescents||||0.47
70894856|NCT02693665|141278056|SUPERIORITY||Slope|1.15|STANDARD_ERROR_OF_MEAN|0.41|<|0.01|TWO_SIDED||||||Regression, Linear|Testing intervention effect for family member quality of communication score controlling for age, gender, race, income nd on active treatment.|This is standard error of the slope.|Quality of communication analysis for family member.||||<0.01
70894857|NCT02693665|141278062|SUPERIORITY||Mean Difference (Net)|0.72|STANDARD_ERROR_OF_MEAN|0.71|<|0.05|TWO_SIDED||||||t-test, 2 sided|||Adolescent positive score comparing intervention with TAU.||||<0.05
70894858|NCT02693665|141278062|SUPERIORITY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.73|<|0.05|TWO_SIDED||||||t-test, 2 sided|||Adolescent negative worded score comparing intervention to TAU.||||<0.05
70894859|NCT02693665|141278062|SUPERIORITY||Mean Difference (Final Values)|2.98|STANDARD_ERROR_OF_MEAN|0.74|<|0.05|TWO_SIDED||||||t-test, 2 sided|||Family member positively worded score comparing intervention with treatment as usual.||||<0.05
70894860|NCT02693665|141278062|SUPERIORITY||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|0.81|<|0.05|TWO_SIDED||||||t-test, 2 sided|||Family member negative worded score comparing intervention to TAU.||||<0.05
70894861|NCT04951336|141278070|SUPERIORITY||ratio of frequencies|0.04||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.000
70894862|NCT04951336|141278071|SUPERIORITY||ratio of frequencies|0.06||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.000
70894863|NCT04951336|141278072|SUPERIORITY||ratio of frequencies|0.7||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.000
70894864|NCT04951336|141278073|SUPERIORITY||ratio of frequencies|1.68||||0.359|TWO_SIDED||||||Chi-squared, Corrected|||||||0.359
70894865|NCT04951336|141278074|SUPERIORITY|age was included as a covariate||||||0.002||||||Differences were considered statistically significant for p-values \<0.05.|Mixed Models Analysis|F(2,150)=6.374. The analysis was repeated using log-transformed values and the resultant p value was also \< 0.05||"The LME analysis compared antibodies between two grouping factors, (1) Treatment Group (FoTv vs. Placebo) and (2) Exposure Stratum (previously exposed vs. unexposed), across four time points (days 3, 14, 28, and 6 months). At baseline, participants with detectable anti-CoV-2 antibodies were deemed previously exposed and those with no or very low anti-CoV-2 Abs previously unexposed. Accordingly, all longitudinal analyses excluded baseline antibody data."||||0.002
70894866|NCT04951336|141278075|SUPERIORITY|age was included as a covariate||||||0.002||||||p \< 0.05.|Mixed Models Analysis|F(2,157)=4.286. The analysis was repeated using log-transformed values and the resultant p value was also \< 0.05||"LME analysis compared antibodies between two grouping factors, (1) Treatment Group (FoTv vs. Placebo) and (2) Exposure Stratum (previously exposed vs. unexposed), across four time points (days 3, 14, 28, and 6 months). At baseline, participants with detectable anti-CoV-2 antibodies were deemed previously exposed and those with no or very low anti-CoV-2 Abs previously unexposed. Accordingly, all longitudinal analyses excluded baseline antibody data."||||0.002
70894867|NCT04951336|141278076|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|F(8,325)=1.898. Age was included as a covariate in this analysis.||LME analysis compared symptoms between two grouping factors, (1) Treatment Group (FoTv vs. Placebo) and (2) Exposure Stratum (previously exposed vs. unexposed), across 5 time points (days 1-5)||||0.060
70894868|NCT04951336|141278077|SUPERIORITY|LME analysis compared symptoms between two grouping factors, (1) Treatment Group (FoTv vs. Placebo) and (2) Exposure Stratum (previously exposed vs. unexposed), across 5 time points (days 1-5)||||||0.326|||||||Mixed Models Analysis|F(8,309)=1.156. Age was included as a covariate in this analysis.||||||0.326
70894869|NCT00127608|141278079|NON_INFERIORITY|The mean viral load between samples stored in liquid and samples stored dry was compared.|Geometric Mean Ratio|0.33|||<|0.0001|||||||ANOVA|Tukey adjustments were made for all 2 by 2 comparisons.|The Geometric Mean Ratio of the viral load was calculated for dry over liquid storage condition.|||||<0.0001
70894870|NCT00127608|141278080|NON_INFERIORITY_OR_EQUIVALENCE|Difference in mean viral load (in log10) (Papule swab minus Vesicle fluid)|Mean Difference (Final Values)|-0.4451||||0.0038||95.0|-0.769|-0.1213|||ANOVA|Tukey adjustments were made for the comparison.||||-0.1213|-0.7690|0.0038
70894871|NCT00127608|141278080|NON_INFERIORITY_OR_EQUIVALENCE|Difference in mean viral load (in log10) (Papule swab minus Vesicle swab)|Median Difference (Final Values)|-0.432||||0.006|TWO_SIDED|95.0|-0.7605|-0.1035|||ANOVA|Tukey adjustments were made for the comparison.||||-0.1035|-0.7605|0.0060
70894872|NCT00127608|141278080|NON_INFERIORITY_OR_EQUIVALENCE|Difference in mean viral load (in log10) (Vesicle fluid minus Vesicle swab)|Mean Difference (Final Values)|0.00132||||0.9952|TWO_SIDED|95.0|-0.3171|0.3435|||ANOVA|Tukey adjustments were made for the comparison.||||0.3435|-0.3171|0.9952
70894873|NCT00127608|141278080|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of viral load (Papule swab over Vesicle fluid)|Geometric mean ratio|0.36|||||TWO_SIDED|95.0|0.17|0.76|||ANOVA|||Geometric mean ratio of viral load (Papule swab over Vesicle fluid)||0.76|0.17|
70894874|NCT00127608|141278080|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of viral load (Papule swab over Vesicle swab)|Geometric mean Ratio|0.37|||||TWO_SIDED|95.0|0.17|0.79|||ANOVA|||Geometric mean ratio of viral load (Papule swab over Vesicle swab)||0.79|0.17|
70894875|NCT00127608|141278080|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of viral load (Vesicle fluid over Vesicle swab)|Geometric mean Ratio|1.0|||||TWO_SIDED|95.0|0.48|2.21|||ANOVA|||Geometric mean ratio of viral load (Vesicle fluid over Vesicle swab)||2.21|0.48|
70894876|NCT02811861|141278086|SUPERIORITY||Stratified Hazard Ratio|0.65|||<|0.0001|TWO_SIDED|95.0|0.53|0.8|||Stratified Log-rank Test|Hazard ratio is based on a Cox Proportional Hazards Model including treatment group as a factor.||||0.80|0.53|<0.0001
70894877|NCT02811861|141278086|SUPERIORITY||Stratified Hazard Ratio|0.39|||<|0.0001|TWO_SIDED|95.0|0.32|0.49|||Stratified Log-rank Test|Hazard ratio is based on a Cox Proportional Hazards Model including treatment group as a factor.||||0.49|0.32|<0.0001
70894878|NCT03912259|141278112|SUPERIORITY||Difference in Percentage|22.0|||<|0.0001|TWO_SIDED|95.0|11.37|32.65||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|P-value was derived by the Cochran-Mantel-Haenszel test stratified by baseline disease severity (IGA=3 vs. IGA=4).||||32.65|11.37|<.0001
70894879|NCT02216123|141278140|OTHER||Mean Difference (Final Values)|1.23|||||TWO_SIDED|95.0|-4.161|4.982|||||Confidence interval for the treatment difference was based on the Newcombe method. Percent treatment difference (TQ+CQ-PQ+CQ) has been presented.|||4.982|-4.161|
70894880|NCT02216123|141278142|OTHER||Hazard Ratio (HR)|0.984||||||95.0|0.577|1.678|||||Hazards ratio was estimated from Cox Proportional Hazards Model with treatment and region as covariates. A hazard ratio \<1 indicates a lower chance of relapse with TQ+CQ compared to PQ+CQ.|||1.678|0.577|
70894881|NCT02216123|141278143|OTHER||Hazard Ratio (HR)|0.815|||||TWO_SIDED|95.0|0.442|1.503|||||Hazard ratio was estimated from Cox Proportional Hazards Model with treatment and region as covariates. A hazard ratio\<1 indicates a lower chance of relapse with TQ+CQ compared to PQ+CQ.|||1.503|0.442|
70894882|NCT00515502|141278220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|95.0|-3.0|2.2|||Mixed Models Analysis|||||2.2|-3.0|
70894883|NCT00515502|141278220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|95.0|-2.1|2.9|||Mixed Models Analysis|||||2.9|-2.1|
70894884|NCT00515502|141278220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|1.77|||TWO_SIDED|95.0|-1.4|5.7|||Mixed Models Analysis|||||5.7|-1.4|
70894885|NCT00515502|141278220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|1.79|||TWO_SIDED|95.0|-6.2|0.9|||Mixed Models Analysis|||||0.9|-6.2|
70894886|NCT00515502|141278220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|1.78|||TWO_SIDED|95.0|-1.3|5.8|||Mixed Models Analysis|||||5.8|-1.3|
70894887|NCT00515502|141278220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|1.89|||TWO_SIDED|95.0|-0.7|6.9|||Mixed Models Analysis|||||6.9|-0.7|
70894888|NCT00515502|141278220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|2.46|||TWO_SIDED|95.0|-0.1|9.7|||Mixed Models Analysis|||||9.7|-0.1|
70894889|NCT00515502|141278221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.844|||TWO_SIDED|95.0|-2.47|0.92|||Mixed Models Analysis|||||0.92|-2.47|
70894890|NCT00515502|141278221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04|STANDARD_ERROR_OF_MEAN|0.798|||TWO_SIDED|95.0|-0.57|2.64|||Mixed Models Analysis|||||2.64|-0.57|
70894891|NCT00515502|141278221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.95|STANDARD_ERROR_OF_MEAN|1.151|||TWO_SIDED|95.0|-0.35|4.26|||Mixed Models Analysis|||||4.26|-0.35|
70894892|NCT00515502|141278221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|1.193|||TWO_SIDED|95.0|-4.11|0.67|||Mixed Models Analysis|||||0.67|-4.11|
70894893|NCT00515502|141278221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.95|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|95.0|-1.44|3.33|||Mixed Models Analysis|||||3.33|-1.44|
70894894|NCT00515502|141278221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.76|STANDARD_ERROR_OF_MEAN|1.257|||TWO_SIDED|95.0|0.24|5.28|||Mixed Models Analysis|||||5.28|0.24|
70894895|NCT00515502|141278221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.68|STANDARD_ERROR_OF_MEAN|1.67|||TWO_SIDED|95.0|0.34|7.02|||Mixed Models Analysis|||||7.02|0.34|
70894896|NCT00515502|141278222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|95.0|-5.0|3.4|||Mixed Models Analysis|||||3.4|-5.0|
70894897|NCT00515502|141278222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|2.03|||TWO_SIDED|95.0|-7.6|0.6|||Mixed Models Analysis|||||0.6|-7.6|
70894898|NCT00515502|141278222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|2.74|||TWO_SIDED|95.0|-2.2|8.7|||Mixed Models Analysis|||||8.7|-2.2|
70894899|NCT00515502|141278222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|2.98|||TWO_SIDED|95.0|-4.7|7.2|||Mixed Models Analysis|||||7.2|-4.7|
70894900|NCT00515502|141278222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|2.83|||TWO_SIDED|95.0|-7.7|3.6|||Mixed Models Analysis|||||3.6|-7.7|
70894901|NCT00515502|141278222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-11.2|1.6|||Mixed Models Analysis|||||1.6|-11.2|
70894902|NCT00515502|141278222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-5.9|10.0|||Mixed Models Analysis|||||10.0|-5.9|
70894903|NCT00515502|141278223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.42|STANDARD_ERROR_OF_MEAN|1.902|||TWO_SIDED|95.0|-6.23|1.39|||Mixed Models Analysis|||||1.39|-6.23|
70894904|NCT00515502|141278223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88|STANDARD_ERROR_OF_MEAN|1.834|||TWO_SIDED|95.0|-5.56|1.79|||Mixed Models Analysis|||||1.79|-5.56|
70894905|NCT00515502|141278223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|2.474|||TWO_SIDED|95.0|-3.82|6.07|||Mixed Models Analysis|||||6.07|-3.82|
70894906|NCT00515502|141278223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|2.697|||TWO_SIDED|95.0|-5.07|5.69|||Mixed Models Analysis|||||5.69|-5.07|
70894907|NCT00515502|141278223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.73|STANDARD_ERROR_OF_MEAN|2.562|||TWO_SIDED|95.0|-7.84|2.38|||Mixed Models Analysis|||||2.38|-7.84|
70894908|NCT00515502|141278223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.19|STANDARD_ERROR_OF_MEAN|2.898|||TWO_SIDED|95.0|-7.97|3.59|||Mixed Models Analysis|||||3.59|-7.97|
70894909|NCT00515502|141278223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|STANDARD_ERROR_OF_MEAN|3.618|||TWO_SIDED|95.0|-6.39|8.02|||Mixed Models Analysis|||||8.02|-6.39|
70894910|NCT00515502|141278224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|95.0|-5.1|0.2|||Mixed Models Analysis|||||0.2|-5.1|
70894911|NCT00515502|141278224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|95.0|-4.6|0.4|||Mixed Models Analysis|||||0.4|-4.6|
70894912|NCT00515502|141278224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|1.67|||TWO_SIDED|95.0|0.0|6.6|||Mixed Models Analysis|||||6.6|-0.0|
70894913|NCT00515502|141278224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|1.77|||TWO_SIDED|95.0|-5.9|1.2|||Mixed Models Analysis|||||1.2|-5.9|
70894914|NCT00515502|141278224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|1.71|||TWO_SIDED|95.0|-3.5|3.3|||Mixed Models Analysis|||||3.3|-3.5|
70894915|NCT00515502|141278224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|95.0|-3.5|4.1|||Mixed Models Analysis|||||4.1|-3.5|
70894916|NCT00515502|141278224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.7|STANDARD_ERROR_OF_MEAN|2.35|||TWO_SIDED|95.0|1.0|10.4|||Mixed Models Analysis|||||10.4|1.0|
70894917|NCT00515502|141278225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.97|STANDARD_ERROR_OF_MEAN|1.051|||TWO_SIDED|95.0|-5.08|-0.87|||Mixed Models Analysis|||||-0.87|-5.08|
70894918|NCT00515502|141278225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|1.006|||TWO_SIDED|95.0|-3.53|0.5|||Mixed Models Analysis|||||0.50|-3.53|
70894919|NCT00515502|141278225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.21|STANDARD_ERROR_OF_MEAN|1.335|||TWO_SIDED|95.0|-0.46|4.88|||Mixed Models Analysis|||||4.88|-0.46|
70894920|NCT00515502|141278225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.32|STANDARD_ERROR_OF_MEAN|1.409|||TWO_SIDED|95.0|-6.13|-0.5|||Mixed Models Analysis|||||-0.50|-6.13|
70894921|NCT00515502|141278225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|1.366|||TWO_SIDED|95.0|-2.38|3.07|||Mixed Models Analysis|||||3.07|-2.38|
70894922|NCT00515502|141278225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|1.514|||TWO_SIDED|95.0|-1.22|4.82|||Mixed Models Analysis|||||4.82|-1.22|
70894923|NCT00515502|141278225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.53|STANDARD_ERROR_OF_MEAN|1.867|||TWO_SIDED|95.0|1.81|9.25|||Mixed Models Analysis|||||9.25|1.81|
70894924|NCT00515502|141278226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.31|STANDARD_ERROR_OF_MEAN|3.256|||TWO_SIDED|95.0|-9.82|3.21|||Mixed Models Analysis|||||3.21|-9.82|
70894925|NCT00515502|141278226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.69|STANDARD_ERROR_OF_MEAN|3.193|||TWO_SIDED|95.0|-4.7|8.09|||Mixed Models Analysis|||||8.09|-4.70|
70894926|NCT00515502|141278226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|4.268|||TWO_SIDED|95.0|-10.06|6.98|||Mixed Models Analysis|||||6.98|-10.06|
70894927|NCT00515502|141278226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.17|STANDARD_ERROR_OF_MEAN|4.347|||TWO_SIDED|95.0|-13.84|3.5|||Mixed Models Analysis|||||3.50|-13.84|
70894928|NCT00515502|141278226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.86|STANDARD_ERROR_OF_MEAN|4.264|||TWO_SIDED|95.0|-6.65|10.37|||Mixed Models Analysis|||||10.37|-6.65|
70894929|NCT00515502|141278226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.86|STANDARD_ERROR_OF_MEAN|4.622|||TWO_SIDED|95.0|-2.35|16.08|||Mixed Models Analysis|||||16.08|-2.35|
70894930|NCT00515502|141278226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.63|STANDARD_ERROR_OF_MEAN|5.634|||TWO_SIDED|95.0|-7.59|14.85|||Mixed Models Analysis|||||14.85|-7.59|
70894931|NCT00515502|141278227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.298|STANDARD_ERROR_OF_MEAN|2.3297|||TWO_SIDED|95.0|-4.961|4.365|||Mixed Models Analysis|||||4.365|-4.961|
70894932|NCT00515502|141278227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.066|STANDARD_ERROR_OF_MEAN|2.2776|||TWO_SIDED|95.0|-3.495|5.627|||Mixed Models Analysis|||||5.627|-3.495|
70894933|NCT00515502|141278227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.062|STANDARD_ERROR_OF_MEAN|3.0952|||TWO_SIDED|95.0|-8.247|4.122|||Mixed Models Analysis|||||4.122|-8.247|
70894934|NCT00515502|141278227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.362|STANDARD_ERROR_OF_MEAN|3.1891|||TWO_SIDED|95.0|-6.003|6.726|||Mixed Models Analysis|||||6.726|-6.003|
70894935|NCT00515502|141278227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|3.1121|||TWO_SIDED|95.0|-6.873|5.554|||Mixed Models Analysis|||||5.554|-6.873|
70894936|NCT00515502|141278227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.704|STANDARD_ERROR_OF_MEAN|3.3916|||TWO_SIDED|95.0|-6.064|7.473|||Mixed Models Analysis|||||7.473|-6.064|
70894937|NCT00515502|141278227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.424|STANDARD_ERROR_OF_MEAN|4.2233|||TWO_SIDED|95.0|-10.84|5.993|||Mixed Models Analysis|||||5.993|-10.84|
70894938|NCT00515502|141278228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|2.542|||TWO_SIDED|95.0|-4.98|5.15|||Mixed Models Analysis|||||5.15|-4.98|
70894939|NCT00515502|141278228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|2.507|||TWO_SIDED|95.0|-3.65|6.34|||Mixed Models Analysis|||||6.34|-3.65|
70894940|NCT00515502|141278228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|3.182|||TWO_SIDED|95.0|-7.49|5.19|||Mixed Models Analysis|||||5.19|-7.49|
70894941|NCT00515502|141278228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|3.296|||TWO_SIDED|95.0|-6.89|6.24|||Mixed Models Analysis|||||6.24|-6.89|
70894942|NCT00515502|141278228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|3.279|||TWO_SIDED|95.0|-6.13|6.94|||Mixed Models Analysis|||||6.94|-6.13|
70894943|NCT00515502|141278228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67|STANDARD_ERROR_OF_MEAN|3.516|||TWO_SIDED|95.0|-5.34|8.67|||Mixed Models Analysis|||||8.67|-5.34|
70894944|NCT00515502|141278228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|4.087|||TWO_SIDED|95.0|-8.97|7.32|||Mixed Models Analysis|||||7.32|-8.97|
70894945|NCT00515502|141278229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.464|STANDARD_ERROR_OF_MEAN|1.9766|||TWO_SIDED|95.0|-2.492|5.419|||Mixed Models Analysis|||||5.419|-2.492|
70894946|NCT00515502|141278229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.248|STANDARD_ERROR_OF_MEAN|1.9457|||TWO_SIDED|95.0|-3.647|4.144|||Mixed Models Analysis|||||4.144|-3.647|
70894947|NCT00515502|141278229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.645|STANDARD_ERROR_OF_MEAN|2.5254|||TWO_SIDED|95.0|-7.687|2.396|||Mixed Models Analysis|||||2.396|-7.687|
70894948|NCT00515502|141278229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.585|STANDARD_ERROR_OF_MEAN|2.6352|||TWO_SIDED|95.0|-2.671|7.84|||Mixed Models Analysis|||||7.840|-2.671|
70894949|NCT00515502|141278229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.121|STANDARD_ERROR_OF_MEAN|2.5993|||TWO_SIDED|95.0|-6.308|4.067|||Mixed Models Analysis|||||4.067|-6.308|
70894950|NCT00515502|141278229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.336|STANDARD_ERROR_OF_MEAN|2.8164|||TWO_SIDED|95.0|-7.952|3.28|||Mixed Models Analysis|||||3.280|-7.952|
70894951|NCT00515502|141278229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.23|STANDARD_ERROR_OF_MEAN|3.3802|||TWO_SIDED|95.0|-11.96|1.504|||Mixed Models Analysis|||||1.504|-11.96|
70894952|NCT00515502|141278230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.2|STANDARD_ERROR_OF_MEAN|2.24|||TWO_SIDED|95.0|-9.7|-0.7|||Mixed Models Analysis|||||-0.7|-9.7|
70894953|NCT00515502|141278230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|2.15|||TWO_SIDED|95.0|-8.9|-0.3|||Mixed Models Analysis|||||-0.3|-8.9|
70894954|NCT00515502|141278230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.7|STANDARD_ERROR_OF_MEAN|2.91|||TWO_SIDED|95.0|-13.5|-1.8|||Mixed Models Analysis|||||-1.8|-13.5|
70894955|NCT00515502|141278230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|3.21|||TWO_SIDED|95.0|-11.8|1.1|||Mixed Models Analysis|||||1.1|-11.8|
70894956|NCT00515502|141278230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|3.12|||TWO_SIDED|95.0|-6.1|6.4|||Mixed Models Analysis|||||6.4|-6.1|
70894957|NCT00515502|141278230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|3.38|||TWO_SIDED|95.0|-6.1|7.5|||Mixed Models Analysis|||||7.5|-6.1|
70894958|NCT00515502|141278230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|4.29|||TWO_SIDED|95.0|-10.9|6.2|||Mixed Models Analysis|||||6.2|-10.9|
70894959|NCT00515502|141278231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-3.6|0.0|||Mixed Models Analysis|||||0.0|-3.6|
70894960|NCT00515502|141278231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|95.0|-2.0|1.4|||Mixed Models Analysis|||||1.4|-2.0|
70894961|NCT00515502|141278231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|1.17|||TWO_SIDED|95.0|-3.9|0.8|||Mixed Models Analysis|||||0.8|-3.9|
70894962|NCT00515502|141278231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|1.3|||TWO_SIDED|95.0|-3.6|1.6|||Mixed Models Analysis|||||1.6|-3.6|
70894963|NCT00515502|141278231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|1.26|||TWO_SIDED|95.0|-3.3|1.7|||Mixed Models Analysis|||||1.7|-3.3|
70894964|NCT00515502|141278231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|95.0|-2.0|3.4|||Mixed Models Analysis|||||3.4|-2.0|
70894965|NCT00515502|141278231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.74|||TWO_SIDED|95.0|-4.1|2.9|||Mixed Models Analysis|||||2.9|-4.1|
70894966|NCT03317002|141278252|SUPERIORITY||Ratio|0.04|||<|0.001|ONE_SIDED|95.0||0.05|||Mixed Models Analysis|||||0.05||<0.001
70894967|NCT03317002|141278252|SUPERIORITY||Ratio|0.08||||0.001|ONE_SIDED|95.0||0.1|||Mixed Models Analysis|||||0.10||0.001
70894968|NCT03317002|141278253|SUPERIORITY||Ratio|0.04|||<|0.001|ONE_SIDED|95.0||0.05|||Mixed Models Analysis|||||0.05||<0.001
70894969|NCT03317002|141278253|SUPERIORITY||Ratio|0.09||||0.001|ONE_SIDED|95.0||0.12|||Mixed Models Analysis|||||0.12||0.001
70894970|NCT05098054|141278323|OTHER||Geometric Least-squares mean(GLSM) Ratio|214.93|||||TWO_SIDED|90.0|103.47|446.45|||||"Geometric least-squares means (LSMs) were calculated by exponentiating the LSMs from the mixed effects model.~Geometric LSM Ratio (GMR) = 100\*(Moderate HI/Normal Hepatic Function (Matched to Moderate HI)"|||446.45|103.47|
70894971|NCT05098054|141278323|OTHER||GLSM Ratio|145.42|||||TWO_SIDED|90.0|77.18|273.98|||||"Geometric LSMs were calculated by exponentiating the LSMs from the mixed effects model.~Geometric LSM Ratio (GMR) = 100\*(Mild HI/Normal Hepatic Function (Matched to Mild HI)"|||273.98|77.18|
70894972|NCT05098054|141278324|OTHER||GLSM Ratio|299.21|||||TWO_SIDED|90.0|111.75|801.17|||||"Geometric LSMs were calculated by exponentiating the LSMs from the mixed effects model.~Geometric LSM Ratio (GMR) = 100\*(Moderate HI/Normal Hepatic Function (Matched to Moderate HI)"|||801.17|111.75|
70894973|NCT05098054|141278324|OTHER||GLSM Ratio|130.25|||||TWO_SIDED|90.0|77.02|220.26|||||"Geometric LSMs were calculated by exponentiating the LSMs from the mixed effects model.~Geometric LSM Ratio (GMR) = 100\*(Mild HI/Normal Hepatic Function (Matched to Mild HI)"|||220.26|77.02|
70894974|NCT05098054|141278325|OTHER||GLSM Ratio|316.27|||||TWO_SIDED|90.0|117.68|849.97|||||"Geometric LSMs were calculated by exponentiating the LSMs from the mixed effects model.~Geometric LSM Ratio (GMR) = 100\*(Moderate HI/Normal Hepatic Function (Matched to Moderate HI)"|||849.97|117.68|
70894975|NCT05098054|141278325|OTHER||GLSM Ratio|135.26|||||TWO_SIDED|90.0|91.22|200.57|||||"Geometric LSMs were calculated by exponentiating the LSMs from the mixed effects model.~Geometric LSM Ratio (GMR) = 100\*(Mild HI/Normal Hepatic Function (Matched to Mild HI)"|||200.57|91.22|
70894976|NCT01426191|141278343|OTHER|||||||0.05|||||||Fisher Exact|||||||0.05
70894977|NCT01426191|141278344|OTHER|||||||0.01|||||||Fisher Exact|||||||0.01
70894978|NCT02013622|141278345|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures (MMRM) method with model terms: baseline, visit, and baseline by visit interaction.||The null hypothesis of zero in mean change from Baseline in PANSS Total Score at Week 16 was tested at significance level of 0.05. Since this is an exploratory trial, no methods to control type I error rate were performed.||||<0.0001
70894979|NCT02013622|141278346|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16||||<0.0001
70894980|NCT02013622|141278347|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16||||<0.0001
70894981|NCT02013622|141278350|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16||||0.0003
70894982|NCT02013622|141278351|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16||||0.0002
70894983|NCT02013622|141278352|SUPERIORITY_OR_OTHER|||||||0.0177|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16||||0.0177
70894984|NCT02013622|141278353|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16 in TSQM-14 effectiveness||||<0.0001
70894985|NCT02013622|141278353|SUPERIORITY_OR_OTHER|||||||0.0031|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16 in TSQM-14 side effects||||0.0031
70894986|NCT02013622|141278353|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16 in TSQM-14 convenience||||0.0005
70894987|NCT02013622|141278353|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16 in TSQM-14 global satisfaction||||<0.0001
70894988|NCT02013622|141278354|SUPERIORITY_OR_OTHER|||||||0.5133|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in Go/No-go task p-inhibition failures (go cues)||||0.5133
70894989|NCT02013622|141278354|SUPERIORITY_OR_OTHER|||||||0.3774|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in Go/No-go task p-inhibition failures (no-go cues)||||0.3774
70894990|NCT02013622|141278355|SUPERIORITY_OR_OTHER|||||||0.8897|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in Go/No-go task mean reaction time (go cues)||||0.8897
70894991|NCT02013622|141278355|SUPERIORITY_OR_OTHER|||||||0.3401|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in Go/No-go task mean reaction time (no-go cues)||||0.3401
70894992|NCT02013622|141278356|SUPERIORITY_OR_OTHER|||||||0.4265|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in DDT||||0.4265
70894993|NCT02013622|141278357|SUPERIORITY_OR_OTHER|||||||0.2923|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in DPDT for Delay Discounting Task k value||||0.2923
70894994|NCT02013622|141278357|SUPERIORITY_OR_OTHER|||||||0.9416|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in DPDT for Probability Discounting Task h value||||0.9416
70894995|NCT02013622|141278358|SUPERIORITY_OR_OTHER|||||||0.1815|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in DRT||||0.1815
70894996|NCT02013622|141278359|SUPERIORITY_OR_OTHER|||||||0.6648|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in AUC for food||||0.6648
70894997|NCT02013622|141278359|SUPERIORITY_OR_OTHER|||||||0.9812|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in AUC for money||||0.9812
70894998|NCT02013622|141278361|SUPERIORITY_OR_OTHER|||||||0.0306|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16||||0.0306
70894999|NCT04307004|141278372|SUPERIORITY|The threshold for statistical significance was p = 0.05|Mean Difference (Final Values)|0.8|||<|0.0001|TWO_SIDED|95.0|0.5|1.1|||Paired T Test, 2-sided||Mean difference in systolic blood pressure = mean systolic blood pressure when attended - mean systolic blood pressure when not attended (i.e., unattended).|||1.1|0.5|< 0.0001
70895000|NCT04307004|141278372|SUPERIORITY||Mean Difference (Final Values)|0.5|||<|0.0001|TWO_SIDED|95.0|0.3|0.7||The threshold for statistical significance was p = 0.05|Paired T Test, 2-sided||Mean difference in diastolic blood pressure = mean diastolic blood pressure when attended - mean diastolic blood pressure when not attended (i.e., unattended)|||0.7|0.3|< 0.0001
70895001|NCT04307004|141278373|SUPERIORITY||Mean Difference (Final Values)|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.5||The threshold for statistical significance was p = 0.05|Paired T Test, 2-sided||Mean difference in systolic blood pressure = mean systolic blood pressure on ambulatory blood pressure monitoring - mean systolic blood pressure on home blood pressure monitoring.|||-1.5|-3.0|< 0.0001
70895002|NCT04307004|141278373|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.4||The threshold for statistical significance was p = 0.05|Paired T Test, 2-sided||Mean difference in diastolic blood pressure = mean diastolic blood pressure on ambulatory blood pressure monitoring - mean diastolic blood pressure on home blood pressure monitoring.|||-1.4|-2.5|< 0.0001
70895003|NCT04307004|141278375|OTHER|Independent variable - Attended systolic blood pressure. Dependent variable - Left ventricular mass index.|beta coefficient|0.43|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|0.32|0.55|||Regression, Linear|||We determined the association between attended systolic blood pressure and left ventricular mass index (LVMI). This analysis included 587 participants with attended office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.55|0.32|< 0.001
70895004|NCT04307004|141278375|OTHER|Independent variable - attended diastolic blood pressure. Dependent variable - left ventricular mass index.|beta coefficient|0.42|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|0.24|0.6|||Regression, Linear|||We determined the association between attended diastolic blood pressure measurements and left ventricular mass index (LVMI). This analysis included 587 with attended office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.60|0.24|< 0.001
70895005|NCT04307004|141278375|OTHER|Independent variable - unattended systolic blood pressure. Dependent variable - left ventricular mass index.|beta coefficient|0.44|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|0.33|0.56|||Regression, Linear|||We determined the association between unattended systolic blood pressure and left ventricular mass index (LVMI). This analysis included 587 participants with unattended office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.56|0.33|< 0.001
70895006|NCT04307004|141278375|OTHER|Independent variable - unattended diastolic blood pressure. Dependent variable - left ventricular mass index.|beta coefficient|0.37|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|0.19|0.55|||Regression, Linear|||We determined the association between unattended diastolic blood pressure and left ventricular mass index (LVMI). This analysis included 587 participants with unattended office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.55|0.19|< 0.001
70895007|NCT04307004|141278375|OTHER|Independent variable - awake systolic blood pressure on ABPM Dependent variable - left ventricular mass index.|beta coefficient|0.61|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|0.47|0.74|||Regression, Linear|||We determined the association between awake systolic blood pressure from ambulatory blood pressure monitoring (ABPM) and left ventricular mass index (LVMI). This analysis included 554 participants with out-of-office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.74|0.47|< 0.001
70895008|NCT04307004|141278375|OTHER|Independent variable - awake diastolic blood pressure on ABPM. Dependent variable - left ventricular mass index.|beta coefficient|0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|0.25|0.66|||Regression, Linear|||We determined the association between awake diastolic blood pressure on ambulatory blood pressure monitoring (ABPM) and left ventricular mass index (LVMI). This analysis included 554 participants with out-of-office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.66|0.25|< 0.001
70895009|NCT04307004|141278375|OTHER|Independent variable - asleep systolic blood pressure on HBPM. Dependent variable - left ventricular mass index.|beta coefficient|0.31|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|0.19|0.44|||Regression, Linear|||We determined the association between asleep systolic blood pressure on home blood pressure monitoring (HBPM) and left ventricular mass index (LVMI). This analysis included 533 participants with HBPM data and valid LVMI. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.44|0.19|< 0.001
70895010|NCT04307004|141278375|OTHER|Independent variable - asleep diastolic blood pressure on HBPM Dependent variable - left ventricular mass index|beta coefficient|0.23|STANDARD_ERROR_OF_MEAN|0.09||0.01|TWO_SIDED|95.0|0.05|0.4|||Regression, Linear|||We determined the association between asleep diastolic blood pressure on home blood pressure monitoring (HBPM) and left ventricular mass index (LVMI). This analysis included 533 participants with data on HBPM and valid LVMI. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.40|0.05|0.01
70895011|NCT04307004|141278375|OTHER|Independent variable - asleep systolic blood pressure on ABPM. Dependent variable - left ventricular mass index.|beta coefficient|0.45|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|0.32|0.59|||Regression, Linear|||We determined the association between asleep systolic blood pressure on ambulatory blood pressure monitoring (ABPM) and left ventricular mass index (LVMI). This analysis included 533 participants with data on ABPM and valid LVMI. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.59|0.32|< 0.001
70895012|NCT04307004|141278375|OTHER|Independent variable - asleep diastolic blood pressure on ABPM Dependent variable - left ventricular mass index.|beta coefficient|0.36|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|0.16|0.55|||Regression, Linear|||We determined the association between asleep diastolic blood pressure on ambulatory blood pressure monitoring (ABPM) and left ventricular mass index (LVMI). This analysis included 533 participants with data on ABPM and valid LVMI. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.55|0.16|< 0.001
70895013|NCT04307004|141278376|OTHER|Independent variable - attended systolic blood pressure. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.17|TWO_SIDED|95.0|-0.47|0.08|||Regression, Linear|||We determined the association between attended systolic blood pressure and urinary albumin-to-creatinine ratio (UACR). This analysis included 555 participants with complete data on attended office blood pressure and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.08|-0.47|0.17
70895014|NCT04307004|141278376|OTHER|Independent variable - attended diastolic blood pressure. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|-0.28|STANDARD_ERROR_OF_MEAN|0.22||0.2|TWO_SIDED|95.0|-0.7|0.15|||Regression, Linear|||We determined the association between attended diastolic blood pressure and urinary albumin-to-creatinine ratio (UACR). This analysis included 555 participants with complete data on attended office blood pressure and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.15|-0.70|0.20
70895015|NCT04307004|141278376|OTHER|Independent variable - unattended systolic blood pressure. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|-0.26|STANDARD_ERROR_OF_MEAN|0.14||0.07|TWO_SIDED|95.0|-0.55|0.02|||Regression, Linear|||We determined the association between unattended systolic blood pressure and urinary albumin-to-creatinine ratio (UACR). This analysis included 555 participants with complete data on unattended blood pressure and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.02|-0.55|0.07
70895016|NCT04307004|141278376|OTHER|Independent variable - unattended diastolic blood pressure. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|-0.37|STANDARD_ERROR_OF_MEAN|0.22||0.09|TWO_SIDED|95.0|-0.8|0.06|||Regression, Linear|||We determined the association between unattended diastolic blood pressure and urinary albumin-to-creatinine ratio (UACR). This analysis included 555 participants with complete data on unattended diastolic blood pressure and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.06|-0.80|0.09
70895017|NCT04307004|141278376|OTHER|"Independent variable - awake systolic blood pressure on ambulatory blood pressure monitoring.~Dependent variable - urinary albumin-to-creatinine ratio."|beta coefficient|0.01|STANDARD_ERROR_OF_MEAN|0.15||0.94|TWO_SIDED|95.0|-0.29|0.31|||Regression, Linear|||We determined the association between awake systolic blood pressure on ambulatory blood pressure monitoring (ABPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 523 participants with complete data on ABPM and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.31|-0.29|0.94
70895018|NCT04307004|141278376|OTHER|"Independent variable - awake diastolic blood pressure on ambulatory blood pressure monitoring.~Dependent variable - urinary albumin-to-creatinine ratio."|beta coefficient|0.22|STANDARD_ERROR_OF_MEAN|0.22||0.31|TWO_SIDED|95.0|-0.21|0.66|||Regression, Linear|||We determined the association between awake diastolic blood pressure on ambulatory blood pressure monitoring (ABPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 523 participants with complete data on ABPM and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.66|-0.21|0.31
70895019|NCT04307004|141278376|OTHER|Independent variable - asleep systolic blood pressure on HBPM. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|-0.01|STANDARD_ERROR_OF_MEAN|0.14||0.94|TWO_SIDED|95.0|-0.28|0.26|||Regression, Linear|||We determined the association between asleep systolic blood pressure on home blood pressure monitoring (HBPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 505 participants with complete HBPM and UACR data. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.26|-0.28|0.94
70895020|NCT04307004|141278376|OTHER|Independent variable - asleep diastolic blood pressure on HBPM. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|-0.02|STANDARD_ERROR_OF_MEAN|0.2||0.93|TWO_SIDED|95.0|-0.4|0.36|||Regression, Linear|||We determined the association between asleep diastolic blood pressure on home blood pressure monitoring (HBPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 505 participants with complete HBPM and UACR data. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.36|-0.40|0.93
70895021|NCT04307004|141278376|OTHER|Independent variable - asleep systolic blood pressure on ABPM. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|0.09|STANDARD_ERROR_OF_MEAN|0.15||0.54|TWO_SIDED|95.0|-0.21|0.4|||Regression, Linear|||We determined the association between asleep systolic blood pressure on ambulatory blood pressure monitoring (ABPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 505 participants with complete ABPM and UACR data. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.40|-0.21|0.54
70895022|NCT04307004|141278376|OTHER|Independent variable - asleep diastolic blood pressure on ABPM. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|0.26|STANDARD_ERROR_OF_MEAN|0.21||0.23|TWO_SIDED|95.0|-0.16|0.68|||Regression, Linear|||We determined the association between asleep diastolic blood pressure on ambulatory blood pressure monitoring (ABPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 505 participants with complete ABPM and UACR data. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.68|-0.16|0.23
70895023|NCT02081846|141278377|SUPERIORITY|||||||0.047|||||||Regression, Logistic|||||||0.047
70895024|NCT02081846|141278378|SUPERIORITY|||||||0.32|||||||Regression, Linear|||||||0.32
70895025|NCT02081846|141278379|SUPERIORITY|||||||0.82|||||||censored Poisson model|||||||0.82
70895026|NCT02081846|141278380|SUPERIORITY||||||<|0.01|||||||Poisson model|||||||<0.01
70895027|NCT02081846|141278381|SUPERIORITY|||||||0.08|||||||Regression, Logistic|||||||0.08
70895028|NCT02081846|141278382|SUPERIORITY|||||||0.052|||||||Regression, Logistic|||||||0.052
70895029|NCT02081846|141278383|SUPERIORITY|||||||0.12|||||||Regression, Logistic|||||||0.12
70895030|NCT02251990|141278394|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p-value was based on a one-sided asymptotic test for a binomial proportion. A one-sided p-value \<0.0125 was considered supportive of a conclusion that the true SVR12 is \>73%.|one-sided asymptotic test|||A one-sided Wald test was used to test the null hypothesis, which was that the SVR12 rate for the ITG was ≤ the historical reference rate of 73%. The historical reference SVR rate for treatment-naive genotype 1 predominantly Asian participants treated with pegylated interferon/ribavirin was derived from 2 studies (PMCID: PMC417, PMCID: PMC3644280) after adjusting for an expected improved safety profile related to an interferon-free regimen.||||<0.001
70895031|NCT02251990|141278395|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.5|||||TWO_SIDED|95.0|-10.6|9.6||||||Estimates and 95% CIs were calculated for between-treatment differences (ITG minus DTG) in the percentage of participants with events using the Miettinen and Nurminen method.||9.6|-10.6|
70895032|NCT02251990|141278396|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.5|||||TWO_SIDED|95.0|-4.2|0.9||||||Estimates and 95% CIs were calculated for between-treatment differences (ITG minus DTG) in the percentage of participants with events using the Miettinen and Nurminen method.||0.9|-4.2|
70895033|NCT03265600|141278399|SUPERIORITY||Odds Ratio (OR)|2.91||||0.006|TWO_SIDED||||||Unadjusted bivariate logistic regression|||||||0.006
70895034|NCT03265600|141278400|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|Cohen's d: -0.25||||||0.19
70895035|NCT03265600|141278401|SUPERIORITY|||||||0.12|||||||Mixed Models Analysis|Cohen's d: -0.36||||||0.12
70895036|NCT03265600|141278402|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|Cohen's d: -0.34||||||0.08
70895037|NCT03265600|141278403|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Cohen's d: 0.57||||||<0.001
70895038|NCT03265600|141278404|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|Cohen's d: 0.41||||||0.03
70895039|NCT03265600|141278405|SUPERIORITY|||||||0.31|||||||Mixed Models Analysis|Cohen's d: 0.15||||||0.31
70895040|NCT03265600|141278406|SUPERIORITY|||||||0.26|||||||Mixed Models Analysis|Cohen's d: 0.22||||||0.26
70895041|NCT03265600|141278407|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Cohen's d: -0.58||||||<0.001
70895042|NCT03265600|141278408|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Cohen's d: 0.75||||||<0.001
70895043|NCT00417079|141278491|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||A 2-sided significance level of 0.0452 was used for the final analysis based on an interim analysis performed after 307 events with an adjusted significance level of 0.016 based on the O'Brien-Fleming type 1 error spending function.|Log Rank|Analysis was performed by using a log-rank comparisons stratified according to disease measurability and ECOG performance status (0-1 versus 2)||The study required an estimated sample size of 720 patients (360 per arm) in order to detect a 25% reduction in the hazard ratio for death in the cabazitaxel group relative to the mitoxantrone group with 90% power. The final analysis was planned for when 511 deaths had occurred.||||<0.0001
70895044|NCT00417079|141278492|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||||||<0.0001
70895045|NCT00417079|141278493|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||Chi-squared|||||||0.0005
70895046|NCT00417079|141278494|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.61|||<|0.0001|TWO_SIDED|95.0|0.49|0.76|||Log Rank|Log-rank comparisons stratified according to disease measurability and ECOG performance status.|Hazard ratio (HR) \< 1 favours the cabazitaxel group and \> 1 favours the mitoxantrone group.|||0.76|0.49|<0.0001
70895047|NCT00417079|141278495|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.75||||0.001|TWO_SIDED|95.0|0.63|0.9|||Log Rank|Log-rank comparisons stratified according to disease measurability and ECOG performance status.|Hazard ratio (HR) \< 1 favours the cabazitaxel group and \> 1 favours the mitoxantrone group.|||0.90|0.63|0.0010
70895048|NCT00417079|141278496|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Chi-squared|||||||0.0002
70895049|NCT00417079|141278497|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.91||||0.5192|TWO_SIDED|95.0|0.69|1.19|||Log Rank|Log-rank comparisons stratified according to disease measurability and ECOG performance status.|Hazard ratio (HR) \< 1 favours the cabazitaxel group and \> 1 favours the mitoxantrone group.|||1.19|0.69|0.5192
70895050|NCT00417079|141278498|SUPERIORITY_OR_OTHER|||||||0.6286||95.0|||||Chi-squared|||||||0.6286
70895051|NCT02512575|141278500|SUPERIORITY_OR_OTHER||Slope|0.847|STANDARD_ERROR_OF_MEAN|0.0238|||TWO_SIDED|90.0|0.807|0.887||||||||0.887|0.807|
70895052|NCT02512575|141278503|SUPERIORITY_OR_OTHER||Slope|0.93|STANDARD_ERROR_OF_MEAN|0.0364|||TWO_SIDED|90.0|0.869|0.991||||||||0.991|0.869|
70895053|NCT02512575|141278504|SUPERIORITY_OR_OTHER||Slope|0.917|STANDARD_ERROR_OF_MEAN|0.0364|||TWO_SIDED|90.0|0.856|0.978||||||||0.978|0.856|
70895054|NCT02512575|141278505|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.03|||||TWO_SIDED|90.0|0.96|1.11||||||||1.11|0.960|
70895055|NCT02512575|141278505|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.0|||||TWO_SIDED|90.0|0.929|1.08||||||||1.08|0.929|
70895056|NCT02512575|141278505|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.06|||||TWO_SIDED|90.0|0.987|1.14||||||||1.14|0.987|
70895057|NCT02512575|141278505|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.06|||||TWO_SIDED|95.0|0.983|1.13||||||||1.13|0.983|
70895058|NCT02512575|141278505|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.07|||||TWO_SIDED|90.0|0.995|1.15||||||||1.15|0.995|
70895059|NCT02512575|141278505|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.17|||||TWO_SIDED|90.0|1.09|1.25||||||||1.25|1.09|
70895060|NCT02512575|141278505|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.15|||||TWO_SIDED|90.0|1.07|1.24||||||||1.24|1.07|
70895061|NCT02512575|141278505|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.2|||||TWO_SIDED|90.0|1.11|1.29||||||||1.29|1.11|
70895062|NCT02512575|141278505|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.19|||||TWO_SIDED|90.0|1.11|1.27||||||||1.27|1.11|
70895063|NCT02512575|141278506|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.05|||||TWO_SIDED|90.0|0.872|1.26||||||||1.26|0.872|
70895064|NCT02512575|141278506|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.05|||||TWO_SIDED|90.0|0.874|1.26||||||||1.26|0.874|
70895065|NCT02512575|141278506|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.907|||||TWO_SIDED|90.0|0.745|1.1||||||||1.10|0.745|
70895066|NCT02512575|141278506|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.914|||||TWO_SIDED|90.0|0.762|1.1||||||||1.10|0.762|
70895067|NCT02512575|141278506|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.876|||||TWO_SIDED|90.0|0.728|1.05||||||||1.05|0.728|
70895068|NCT02512575|141278506|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.86|||||TWO_SIDED|90.0|0.716|1.03||||||||1.03|0.716|
70895069|NCT02512575|141278506|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.01|||||TWO_SIDED|90.0|0.842|1.21||||||||1.21|0.842|
70895070|NCT02512575|141278506|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.02|||||TWO_SIDED|90.0|0.846|1.22||||||||1.22|0.846|
70895071|NCT02512575|141278506|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.687|||||TWO_SIDED|90.0|0.572|0.825||||||||0.825|0.572|
70895072|NCT02512575|141278507|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.982|||||TWO_SIDED|90.0|0.861|1.12||||||||1.12|0.861|
70895073|NCT02512575|141278507|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.961||||||90.0|0.846|1.09||||||||1.09|0.846|
70895074|NCT02512575|141278507|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.942|||||TWO_SIDED|90.0|0.829|1.07||||||||1.07|0.829|
70895075|NCT02512575|141278507|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.861|||||TWO_SIDED|90.0|0.757|0.979||||||||0.979|0.757|
70895076|NCT02512575|141278507|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.848|||||TWO_SIDED|90.0|0.745|0.964||||||||0.964|0.745|
70895077|NCT02512575|141278507|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.927|||||TWO_SIDED|90.0|0.815|1.05||||||||1.05|0.815|
70895078|NCT02512575|141278507|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.907|||||TWO_SIDED|90.0|0.798|1.03||||||||1.03|0.798|
70895079|NCT02512575|141278507|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.893|||||TWO_SIDED|90.0|0.784|1.02||||||||1.02|0.784|
70895080|NCT02512575|141278507|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.691||||||90.0|0.608|0.785||||||||0.785|0.608|
70895081|NCT01022762|141278524|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be shown if the upper limit of the 95% confidence interval was less than 0.4%. This corresponds to a one-sided test with a significance level of 2.5% of the hypothesis.|Mean Difference (Net)|0.014|STANDARD_ERROR_OF_MEAN|0.066||||95.0|-0.115|0.143||The p-value corresponds to one-sided hypotheses of superiority with a significance level of 2.5%.|ANCOVA|ANCOVA model was with treatment, centre as explanatory variables and baseline HbA1c value as covariate.|If non-inferiority of repaglinide alone was shown, a test for superiority would be performed based on FAS. Superiority of repaglinide alone over gliclazide alone would be claimed if the upper limit of the 95% CI for the difference was lower than 0%.|H0: Change from baseline in HbA1c of repaglinide therapy at 16 weeks of treatment - change from baseline in HbA1c of gliclazide therapy at 16 weeks of treatment \>= 0.4%. H1: Change from baseline in HbA1c of repaglinide therapy at 16 weeks of treatment - change from baseline in HbA1c of gliclazide therapy at 16 weeks of treatment \< 0.4%. Sample size was calculated to achieve a power of at least 85%, assuming an equal change in HbA1c and a common standard deviation of 1.2%.||0.143|-0.115|
70895082|NCT01302119|141278535|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70895083|NCT01302119|141278536|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70895084|NCT01302119|141278537|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70895085|NCT01302119|141278538|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70895086|NCT02235493|141278539|SUPERIORITY_OR_OTHER|||||||0.0625|TWO_SIDED|||||The p-value is based on a nonparametric sign test to determine whether the median of change from Baseline in MPOMA-G score differs from 0. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||Videos were reviewed and scored by 3 independent raters who were masked to patient identifiers and the clinic visits and dates when the videos were recorded. Each rater scored the individual components required for the calculation of the total MPOMA-G score for each evaluable patient video. The median of the scores across the 3 raters was obtained for each individual component and summed to generate the median MPOMA-G score used in the analyses.||||0.0625
70895087|NCT02235493|141278540|SUPERIORITY_OR_OTHER|||||||0.125|TWO_SIDED|||||The p-value is based on a nonparametric sign test to determine whether the median of change from Baseline in POMA-G score differs from 0. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||Videos were reviewed and scored by 3 independent raters who were masked to patient identifiers and the clinic visits and dates when the videos were recorded. Each rater scored the individual components required for the calculation of the total POMA-G score for each evaluable patient video. The median of the scores across the 3 raters was obtained for each individual component and summed to generate the median POMA-G score used in the analyses.||||0.1250
70895088|NCT03336619|141278541|SUPERIORITY|||||||0.3765|||||||Gehan-Wilcoxon|Analysis used a Gehan-Wilcoxon test stratified by time from symptom onset at enrollment and influenza vaccination status.||||||0.3765
70895089|NCT03336619|141278542|SUPERIORITY|||||||0.6331|||||||Gehan-Wilcoxon|Gehan-Wilcoxon test stratified by time from symptom onset at enrollment and influenza vaccination status.||||||0.6331
70895090|NCT03336619|141278543|SUPERIORITY|||||||0.7382|||||||Fisher Exact|||||||0.7382
70895091|NCT03336619|141278544|SUPERIORITY|||||||0.3236|||||||Gehan-Wilcoxon|Gehan-Wilcoxon test stratified by time from symptom onset to enrollment and influenza vaccination status.||||||0.3236
70895092|NCT03336619|141278545|SUPERIORITY|||||||0.0483|||||||Gehan-Wilcoxon|Gehan-Wilcoxon test stratified by time from symptom onset at enrollment and influenza vaccination status.||||||0.0483
70895093|NCT01316926|141278557|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency - ANVISA - upon manufacturing a site change.|Ratio T formulation/R formulation|0.9204|||||TWO_SIDED|90.0|0.8556|0.99|||||Coefficient Variation (intra-individual). The ratio between the geometric means of the test and reference formulations was calculated.|||0.9900|0.8556|
70895094|NCT01316926|141278558|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency - ANVISA - upon manufacturing a site change.|Ratio T formulation/R formulation|0.941|||||TWO_SIDED|90.0|0.846|1.0467|||||Coefficient Variation (intra-individual). The ratio between the geometric means of the test and reference formulations was calculated.|||1.0467|0.8460|
70895095|NCT01316926|141278559|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency - ANVISA - upon manufacturing a site change.|Ratio T formulation/R formulation|0.9333|||||TWO_SIDED|90.0|0.8502|1.0246|||||Coefficient Variation (intra-individual). The ratios between the geometric means of the test and reference formulations was calculated.|||1.0246|0.8502|
70895096|NCT01680328|141278639|SUPERIORITY_OR_OTHER||Least Squares Mean|-0.1||||||95.0|-2.9|2.8||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.||2.8|-2.9|
70895097|NCT01680328|141278639|SUPERIORITY_OR_OTHER||Least Squares Mean|3.5||||||95.0|0.4|6.6||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.||6.6|0.4|
70895098|NCT01680328|141278639|SUPERIORITY_OR_OTHER||Least Squares Mean|7.2||||||95.0|4.6|9.7||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.||9.7|4.6|
70895099|NCT01680328|141278639|SUPERIORITY_OR_OTHER||Least Squares Mean|3.6||||||95.0|0.4|6.7||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.||6.7|0.4|
70895100|NCT01680328|141278639|SUPERIORITY_OR_OTHER||Least Squares Mean|7.2||||||95.0|4.4|10.0||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.||10.0|4.4|
70895101|NCT01680328|141278639|SUPERIORITY_OR_OTHER||Least Squares Mean|3.7||||||95.0|0.6|6.7||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.||6.7|0.6|
70895102|NCT01680328|141278639|SUPERIORITY_OR_OTHER||Least Squares Mean|0.4||||||95.0|-2.1|2.9||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean difference in injection pain on VAS after injection at different speeds was calculated as least square mean estimate of the mean difference in injection pain on a VAS after injection at different speeds.||2.9|-2.1|
70895103|NCT01680328|141278639|SUPERIORITY_OR_OTHER||Least Squares Mean|-0.4||||||95.0|-2.7|1.9||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean difference in injection pain on VAS after injection at different speeds was calculated as least square mean estimate of the mean difference in injection pain on a VAS after injection at different speeds.||1.9|-2.7|
70895104|NCT01680328|141278639|SUPERIORITY_OR_OTHER||Least Squares Mean|9.0||||||95.0|6.7|11.3||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. The mean difference in injection pain on a VAS (mm) between the thighs and abdomen was calculated as the least square mean estimate of the mean difference in injection pain on a VAS (mm) between the thighs and abdomen.||11.3|6.7|
70895105|NCT01680328|141278640|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||||95.0|0.5|1.4|||Odds ratio (OR)|||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||1.4|0.5|
70895106|NCT01680328|141278640|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1||||||95.0|1.2|3.5||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||3.5|1.2|
70895107|NCT01680328|141278640|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1||||||95.0|1.4|3.0||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||3.0|1.4|
70895108|NCT01680328|141278640|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.6||||||95.0|1.4|4.8||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||4.8|1.4|
70895109|NCT01680328|141278640|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.6||||||95.0|1.4|4.6||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||4.6|1.4|
70895110|NCT01680328|141278640|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||||95.0|0.7|1.5||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||1.5|0.7|
70895111|NCT01680328|141278641|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||||95.0|0.7|1.8||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'higher speed versus lower', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the higher speed - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||1.8|0.7|
70895112|NCT01680328|141278641|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||||95.0|0.6|1.2||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'higher speed versus lower', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the higher speed - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||1.2|0.6|
70895113|NCT01680328|141278642|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.7||||||95.0|2.4|5.5|||Odds ratio (OR)|||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain in the thighs - i.e. a worse condition.||5.5|2.4|
70895114|NCT01680328|141278643|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.6||||||95.0|-0.6|1.8||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||1.8|-0.6|
70895115|NCT01680328|141278643|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.4||||||95.0|-0.8|1.6||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||1.6|-0.8|
70895116|NCT01680328|141278643|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.9||||||95.0|-0.4|2.1||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||2.1|-0.4|
70895117|NCT01680328|141278643|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.5||||||95.0|-0.8|1.7||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||1.7|-0.8|
70895118|NCT01680328|141278643|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.5||||||95.0|-0.8|1.7||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||1.7|-0.8|
70895119|NCT01680328|141278643|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.5||||||95.0|-0.7|1.8||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||1.8|-0.7|
70895120|NCT01680328|141278643|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.9||||||95.0|-0.3|2.1||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||2.1|-0.3|
70895121|NCT01680328|141278643|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.8||||||95.0|-0.4|2.0||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||2.0|-0.4|
70895122|NCT01680328|141278643|SUPERIORITY_OR_OTHER||Least Square Mean Difference|1.1||||||95.0|-0.1|2.3||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||2.3|-0.1|
70895123|NCT01680328|141278643|SUPERIORITY_OR_OTHER||Least Square Mean Difference|2.3||||||95.0|1.0|3.5||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||3.5|1.0|
70895124|NCT01680328|141278643|SUPERIORITY_OR_OTHER||Least Square Mean Difference|1.4||||||95.0|0.2|2.6||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||2.6|0.2|
70895125|NCT01680328|141278643|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.6||||||95.0|-0.6|1.8||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||1.8|-0.6|
70895126|NCT01680328|141278644|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.3||||||95.0|-0.9|1.5||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.||1.5|-0.9|
70895127|NCT01680328|141278644|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.8||||||95.0|-0.4|2.1||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.||2.1|-0.4|
70895128|NCT01680328|141278644|SUPERIORITY_OR_OTHER||Least Square Mean Difference|1.6||||||95.0|0.3|2.8||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.||2.8|0.3|
70895129|NCT01680328|141278644|SUPERIORITY_OR_OTHER||Least Square Mean Difference|4.9||||||95.0|3.7|6.1||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.||6.1|3.7|
70895130|NCT01680328|141278644|SUPERIORITY_OR_OTHER||Least Square Mean Difference|1.7||||||95.0|0.5|2.9||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.||2.9|0.5|
70895131|NCT02959996|141278666|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
70895132|NCT02959996|141278667|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||.14
70895133|NCT02959996|141278668|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
70895134|NCT02962908|141278675|OTHER|Inequality test.||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IFN-gamma from day 0 and to 42.||||0.45
70895135|NCT02962908|141278675|OTHER|inequality test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IFN-gamma from day 0 and to 42.||||<0.001
70895136|NCT02962908|141278675|OTHER|inequality test||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for TNF-alpha from day 0 to day 42.||||0.88
70895137|NCT02962908|141278675|OTHER|inequality test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for TNF-alpha from day 0 to day 42.||||<0.001
70895138|NCT02962908|141278675|OTHER|inequality test||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IL-2 from day 0 to day 42.||||0.21
70895139|NCT02962908|141278675|OTHER|inequality test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IL-2 from day 0 to day 42.||||<0.001
70895140|NCT02962908|141278675|OTHER|inequality test||||||0.77|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for CD107a from day 0 to day 42.||||0.77
70895141|NCT02962908|141278675|OTHER|inequality test||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for CD107a from day 0 to day 42.||||0.004
70895142|NCT02962908|141278675|OTHER|inequality test||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IFN-gamma from day 0 to day 42.||||0.08
70895143|NCT02962908|141278675|OTHER|inequality test||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IFN-gamma from day 0 to day 42.||||0.38
70895144|NCT02962908|141278675|OTHER|inequality test||||||0.49|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for TNF-alpha from day 0 to day 42.||||0.49
70895145|NCT02962908|141278675|OTHER|inequality test||||||0.156|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for TNF-alpha from day 0 to day 42.||||0.156
70895146|NCT02962908|141278675|OTHER|inequality test||||||0.125|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IL-2 from day 0 to day 42.||||0.125
70895147|NCT02962908|141278675|OTHER|inequality test||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
70895148|NCT02962908|141278675|OTHER|inequality test||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for CD107a from day 0 to day 42.||||0.72
70895149|NCT02962908|141278675|OTHER|inequality test||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for CD107a from day 0 to day 42.||||0.34
70895150|NCT02962908|141278676|OTHER|inequality test||||||0.62|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IFN-gamma from day 0 to day 180.||||0.62
70895151|NCT02962908|141278676|OTHER|inequality test||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IFN-gamma from day 0 to day 180.||||0.030
70895152|NCT02962908|141278676|OTHER|inequality test||||||0.87|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for TNF-alpha from day 0 to day 180.||||0.87
70895153|NCT02962908|141278676|OTHER|inequality test||||||0.075|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for TNF-alpha from day 0 to day 180.||||0.075
70895154|NCT02962908|141278676|OTHER|inequality test||||||0.076|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IL-2 from day 0 to day 180.||||0.076
70895155|NCT02962908|141278676|OTHER|inequality test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IL-2 from day 0 to day 180.||||<0.001
70895156|NCT02962908|141278676|OTHER|inequality test||||||0.91|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for CD107a from day 0 to day 180.||||0.91
70895157|NCT02962908|141278676|OTHER|inequality test||||||0.91|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for CD107a from day 0 to day 180.||||0.91
70895158|NCT02962908|141278676|OTHER|inequality test||||||0.55|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IFN-gamma from day 0 to day 180.||||0.55
70895159|NCT02962908|141278676|OTHER|inequality test||||||0.55|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IFN-gamma from day 0 to day 180.||||0.55
70895160|NCT02962908|141278676|OTHER|inequality||||||0.91|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for TNF-alpha from day 0 to day 180.||||0.91
70895161|NCT02962908|141278676|OTHER|inequality test||||||0.91|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for TNF-alpha from day 0 to day 180.||||0.91
70895162|NCT02962908|141278676|OTHER|inequality test||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IL2 from day 0 to day 180.||||0.21
70895163|NCT02962908|141278676|OTHER|inequality test||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IL2 from day 0 to day 180.||||0.48
70895164|NCT02962908|141278676|OTHER|inequality test||||||0.62|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for CD107a from day 0 to day 180.||||0.62
70895165|NCT02962908|141278676|OTHER|inequality||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for CD107a from day 0 to day 180.||||0.23
70895166|NCT02962908|141278677|OTHER|inequality test||||||0.8|||||||Chi-squared|||Comparison of CD4+ IFNgamma responders on day 42. Differences considered significant if p-value \<0.05.||||0.80
70895167|NCT02962908|141278677|OTHER|inequality test|||||<|0.001|||||||Fisher Exact|||Comparison of CD4+ IFNgamma responders on day 42. Differences considered significant if p-value \<0.05.||||<0.001
70895168|NCT02962908|141278677|OTHER|inequality test||||||0.23|||||||Chi-squared|||Comparison of CD4+ TNF alpha responders on day 42. Differences considered significant if p-value \<0.05.||||0.23
70895169|NCT02962908|141278677|OTHER|||||||0.056|||||||Chi-squared|||Comparison of CD4+ TNF alpha responders on day 42. Differences considered significant if p-value \<0.05.||||0.056
70895170|NCT02962908|141278677|OTHER|inequality test||||||0.74|||||||Chi-squared|||Comparison of CD4+ IL-2 responders on day 42. Differences considered significant if p-value \<0.05.||||0.74
70895171|NCT02962908|141278677|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||Comparison of CD4+ IL-2 responders on day 42. Differences considered significant if p-value \<0.05.||||<0.001
70895172|NCT02962908|141278677|OTHER|inequality test||||||0.34|||||||Fisher Exact|||Comparison of CD4+ CD107a responders on day 42. Differences considered significant if p-value \<0.05.||||0.34
70895173|NCT02962908|141278677|OTHER|inequality test||||||0.01|||||||Fisher Exact|||Comparison of CD4+ CD107a responders on day 42. Differences considered significant if p-value \<0.05.||||0.010
70895174|NCT02962908|141278677|OTHER|inequality test||||||0.096|||||||Chi-squared|||Comparison of CD4+ IFNgamma responders on day 180. Differences considered significant if p-value \<0.05.||||0.096
70895175|NCT02962908|141278677|OTHER|inequality test||||||0.049|||||||Fisher Exact|||Comparison of CD4+ IFNgamma responders on day 180.Differences considered significant if p-value \<0.05.||||0.049
70895176|NCT02962908|141278677|OTHER|inequality test||||||0.91|||||||Chi-squared|||Comparison of CD4+ TNF alpha responders on day 180. Differences considered significant if p-value \<0.05.||||0.91
70895177|NCT02962908|141278677|OTHER|||||||0.39|||||||Chi-squared|||Comparison of CD4+ TNF alpha responders on day 180. Differences considered significant if p-value \<0.05.||||0.39
70895178|NCT02962908|141278677|OTHER|inequality test||||||0.94|||||||Chi-squared|||Comparison of CD4+ IL-2 responders on day 180. Differences considered significant if p-value \<0.05.||||0.94
70895179|NCT02962908|141278677|OTHER|inequality test|||||<|0.001|||||||Fisher Exact|||Comparison of CD4+ IL-2 responders on day 180. Differences considered significant if p-value \<0.05.||||<0.001
70895180|NCT02962908|141278677|OTHER|inequality test||||||0.044|||||||Fisher Exact|||Comparison of CD4+ CD107a responders on day 180. Differences considered significant if p-value \<0.05.||||0.044
70895181|NCT02962908|141278677|OTHER|inequality test||||||0.98|||||||Fisher Exact|||Comparison of CD4+ CD107a responders on day 180. Differences considered significant if p-value \<0.05.||||0.98
70895182|NCT02962908|141278677|OTHER|inequality test||||||0.48|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IFN-gamma responders on day 42. Differences considered significant if p-value \<0.05.||||0.48
70895183|NCT02962908|141278677|OTHER|inequality test||||||0.28|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IFN-gamma responders on day 42. Differences considered significant if p-value \<0.05.||||0.28
70895184|NCT02962908|141278677|OTHER|inequality test||||||0.7|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ TNF-alpha responders on day 42. Differences considered significant if p-value \<0.05.||||0.70
70895185|NCT02962908|141278677|OTHER|inequality test||||||0.175|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ TNF-alpha responders on day 42. Differences considered significant if p-value \<0.05.||||0.175
70895186|NCT02962908|141278677|OTHER|inequality test||||||0.24|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IL2 responders on day 42. Differences considered significant if p-value \<0.05.||||0.24
70895187|NCT02962908|141278677|OTHER|inequality test||||||0.8|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IL2 responders on day 42. Differences considered significant if p-value \<0.05.||||0.80
70895188|NCT02962908|141278677|OTHER|inequality test||||||0.023|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ CD107a responders on day 42. Differences considered significant if p-value \<0.05.||||0.023
70895189|NCT02962908|141278677|OTHER|inequality test||||||0.015|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ CD107a responders on day 42. Differences considered significant if p-value \<0.05.||||0.015
70895190|NCT02962908|141278677|OTHER|inequality test||||||0.81|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IFN-gamma responders on day 180. Differences considered significant if p-value \<0.05.||||0.81
70895191|NCT02962908|141278677|OTHER|inequality test||||||0.34|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IFN-gamma responders on day 180. Differences considered significant if p-value \<0.05.||||0.34
70895192|NCT02962908|141278677|OTHER|inequality test||||||0.3|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ TNF-alpha responders on day 180. Differences considered significant if p-value \<0.05.||||0.30
70895193|NCT02962908|141278677|OTHER|inequality test||||||0.105|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ TNF-alpha responders on day 180. Differences considered significant if p-value \<0.05.||||0.105
70895194|NCT02962908|141278677|OTHER|inequality test||||||0.38|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IL2 responders on day 180. Differences considered significant if p-value \<0.05.||||0.38
70895195|NCT02962908|141278677|OTHER|inequality test||||||0.44|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IL2 responders on day 180. Differences considered significant if p-value \<0.05.||||0.44
70895196|NCT02962908|141278677|OTHER|inequality test||||||0.58|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ CD107a responders on day 180. Differences considered significant if p-value \<0.05.||||0.58
70895197|NCT02962908|141278677|OTHER|inequality test||||||0.43|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ CD107a responders on day 180. Differences considered significant if p-value \<0.05.||||0.43
70895198|NCT02962908|141278678|OTHER|inequality test||||||0.25|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IFN-gamma at day 42||||0.25
70895199|NCT02962908|141278678|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing TNF-alpha at day 42||||1.0
70895200|NCT02962908|141278678|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IL-2 at day 42||||1.00
70895201|NCT02962908|141278678|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing CD107a at day 42||||1.00
70895202|NCT02962908|141278678|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IFN-gamma at day 42||||<0.001
70895203|NCT02962908|141278678|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing TNF-alpha at day 42||||<0.001
70895204|NCT02962908|141278678|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IL2 at day 42||||<0.001
70895205|NCT02962908|141278678|OTHER|inequality test||||||0.31|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing CD107a at day 42||||0.31
70895206|NCT02962908|141278678|OTHER|inequality test||||||0.48|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IFN-gamma at day 180||||0.48
70895207|NCT02962908|141278678|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing TNF-alpha at day 180||||1.00
70895208|NCT02962908|141278678|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IL2 at day 180||||1.00
70895209|NCT02962908|141278678|OTHER|inequality test||||||0.59|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing CD107a at day 180||||0.59
70895210|NCT02962908|141278678|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IFN-gamma at day 180||||<0.001
70895211|NCT02962908|141278678|OTHER|inequality test||||||0.013|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing TNF-alpha at day 180||||0.013
70895212|NCT02962908|141278678|OTHER|inequality|||||<|0.001|||||||Chi-squared|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IL2 at day 180||||<0.001
70895213|NCT02962908|141278678|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing CD107a at day 180||||1.00
70895214|NCT02962908|141278678|OTHER|inequality test||||||0.55|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing IFN-gamma at day 42||||0.55
70895215|NCT02962908|141278678|OTHER|inequality test||||||0.55|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing IFN-gamma at day 42||||0.55
70895216|NCT02962908|141278678|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing TNF-alpha at day 42||||1.00
70895217|NCT02962908|141278678|OTHER|inequality test||||||0.29|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing IFN-gamma at day 180||||0.29
70895218|NCT02962908|141278678|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing TNF-alpha at day 180||||1.00
70895219|NCT02962908|141278678|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing IFN-gamma at day 180||||1.00
70895220|NCT02962908|141278678|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing TNF-alpha at day 180||||1.00
70895221|NCT02962908|141278678|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing CD107a at day 180||||1.00
70895222|NCT02962908|141278679|OTHER|inequality test||||||0.59|||||||Wilcoxon (Mann-Whitney)|||Comparison of median fold-increase in IFN-gamma secretion as measured by ELISA on day 42. p\<0.05 considered statistically significant.||||0.59
70895223|NCT02962908|141278679|OTHER|inequality test||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of median fold-increase in IFN-gamma secretion as measured by ELISA on day 42. p\<0.05 considered statistically significant.||||0.001
70895224|NCT02962908|141278679|OTHER|inequality test||||||0.61|||||||Wilcoxon (Mann-Whitney)|||Comparison of median fold-increase in IFN-gamma secretion as measured by ELISA on day 180. p\<0.05 considered statistically significant.||||0.61
70895225|NCT02962908|141278679|OTHER|inequality test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of median fold-increase in IFN-gamma secretion as measured by ELISA on day 180. p\<0.05 considered statistically significant.||||<0.001
70895226|NCT02962908|141278680|OTHER|||||||0.113|||||||Wilcoxon (Mann-Whitney)|||"Comparison of number of responders on day 42. A subject was considered a responder if an increase of secreted IFNgamma of at least two fold was observed from day 0 to day 42."||||0.113
70895227|NCT02962908|141278680|OTHER||||||<|0.001|||||||Fisher Exact|||"Comparison of number of responders on day 42. A subject was considered a responder if an increase of secreted IFNgamma of at least two fold was observed from day 0 to day 42."||||<0.001
70895228|NCT02962908|141278680|OTHER|||||||0.399|||||||Chi-squared|||"Comparison of number of responders on day 180. A subject was considered a responder if an increase of secreted IFNgamma of at least two fold was observed from day 0 to day 180."||||0.399
70895229|NCT02962908|141278680|OTHER||||||<|0.001|||||||Fisher Exact|||"Comparison of number of responders on day 180. A subject was considered a responder if an increase of secreted IFNgamma of at least two fold was observed from day 0 to day 180."||||<0.001
70895230|NCT02962908|141278682|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of geometric mean IgG titers specific to FLU-v antigens on day 42 post-vaccination.||||<0.001
70895231|NCT02962908|141278682|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of geometric mean IgG titers specific to FLU-v antigens on day 42.||||<0.001
70895232|NCT02962908|141278682|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of geometric mean IgG titers specific to FLU-v antigens on day 180.||||<0.001
70895233|NCT02962908|141278682|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of geometric mean IgG titers specific to FLU-v antigens on day 180.||||<0.001
70895234|NCT02962908|141278685|OTHER|||||||0.662|||||||Fisher Exact|||Differences in the infection rates against any of the strains tested between treatment group and corresponding placebo.||||0.662
70895235|NCT02962908|141278685|OTHER|||||||0.168|||||||Fisher Exact|||Differences in the infection rates against any of the strains tested between treatment group and corresponding placebo.||||0.168
70895236|NCT02962908|141278686|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)||||The study was not powered to detected statistical significant differences in this outcome.|||>0.05
70895237|NCT02962908|141278686|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)||||Study not powered to detect statistically significant differences|||>0.05
70895238|NCT02962908|141278687|OTHER|||||||0.513|||||||Wilcoxon (Mann-Whitney)|||Comparison in the duration of symptoms between treatment group and corresponding placebo.||||0.513
70895239|NCT02962908|141278687|OTHER|||||||0.578|||||||Wilcoxon (Mann-Whitney)|||Comparison of the duration of symptoms between treatment group and corresponding placebo.||||0.578
70895240|NCT02962908|141278687|OTHER|||||||0.513|||||||Wilcoxon (Mann-Whitney)|||Comparison of total symptom score between treatment group and corresponding placebo.||||0.513
70895241|NCT02962908|141278687|OTHER|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Comparison of the total symptom score between treatment group and corresponding placebo.||||0.200
70895242|NCT02962908|141278687|OTHER|||||||0.658|||||||Wilcoxon (Mann-Whitney)|||Comparison of the symptom peak between treatment group and corresponding placebo.||||0.658
70895243|NCT02962908|141278687|OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Comparison of the symptom peak between treatment group and corresponding placebo.||||0.640
70895244|NCT02962908|141278687|OTHER|||||||0.127|||||||Wilcoxon (Mann-Whitney)|||Comparison of the average symptom score between treatment group and corresponding placebo.||||0.127
70895245|NCT02962908|141278687|OTHER|||||||0.201|||||||Wilcoxon (Mann-Whitney)|||Comparison of the average symptom score between treatment group and corresponding placebo.||||0.201
70895246|NCT02962908|141278688|OTHER|inequality test||||||0.85|||||||Chi-squared|||comparison between groups on day 42||||0.85
70895247|NCT02962908|141278688|OTHER|inequality test||||||0.042|||||||Fisher Exact|||comparison between groups on day 42||||0.042
70895248|NCT02962908|141278688|OTHER|inequality test||||||0.69|||||||Fisher Exact|||comparison between groups on day 180||||0.69
70895249|NCT02962908|141278688|OTHER|inequality test||||||0.198|||||||Fisher Exact|||comparison between groups on day 180||||0.198
70895250|NCT02962908|141278688|OTHER|inequality test||||||0.092|||||||Chi-squared|||comparison between groups on day 42||||0.092
70895251|NCT02962908|141278688|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||comparison of groups on day 42||||<0.001
70895252|NCT02962908|141278688|OTHER|inequality test||||||0.27|||||||Chi-squared|||comparison of groups on day 180||||0.27
70895253|NCT02962908|141278688|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||comparisons between groups on day 180||||<0.001
70895254|NCT00936390|141278689|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.22|TWO_SIDED|95.0|0.65|1.11||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|This study was designed to detect an improvement in the 5-year overall survival rate from 90% (radiation alone arm) to 93.3% (radiation and androgen deprivation arm). Assuming an exponential survival distribution for each arm, this translates to a 34% relative reduction (hazard ratio 0.66) in the yearly death rate. At least 218 deaths provide 85% power with a 1-sided significance level of 0.025 and 85% power.||1.11|0.65|0.22
70895255|NCT00936390|141278690|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.39|0.7||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||0.70|0.39|<0.001
70895256|NCT00936390|141278690|SUPERIORITY||||||<|0.001||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||Cumulative incidence model||||<0.001
70895257|NCT00936390|141278691|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.02|TWO_SIDED|95.0|0.22|0.9||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||0.90|0.22|0.020
70895258|NCT00936390|141278691|SUPERIORITY|Cumulative incidence model||||||0.021||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||||||0.021
70895259|NCT00936390|141278693|SUPERIORITY||Hazard Ratio (HR)|0.25|||<|0.001|TWO_SIDED|95.0|0.11|0.57||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||0.57|0.11|<0.001
70895260|NCT00936390|141278693|SUPERIORITY||||||<|0.001||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||Cumulative incidence model||||<0.001
70895261|NCT00936390|141278694|SUPERIORITY||Hazard Ratio (HR)|0.1||||0.0073|TWO_SIDED|95.0|0.01|0.8||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||0.80|0.01|0.0073
70895262|NCT00936390|141278694|SUPERIORITY|||||||0.007||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||Cumulative incidence model||||0.007
70895263|NCT00936390|141278695|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.52|TWO_SIDED|95.0|0.7|1.2||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||1.20|0.70|0.52
70895264|NCT00936390|141278695|SUPERIORITY|||||||0.56||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||Cumulative incidence model||||0.56
70895265|NCT00936390|141278696|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.025|TWO_SIDED|95.0|0.41|0.95||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||0.95|0.41|0.025
70895266|NCT00936390|141278696|SUPERIORITY|||||||0.025||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||Cumulative incidence model||||0.025
70895267|NCT00936390|141278698|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70895268|NCT00936390|141278699|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.13|TWO_SIDED|95.0|0.89|1.53||One-sided significance level 0.025 (reported p-value is one-sided)|Gray's test||Reference level = radiation therapy alone arm|||1.53|0.89|0.13
70895269|NCT00936390|141278700|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.39|0.7||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||0.70|0.39|<0.001
70895270|NCT00936390|141278700|SUPERIORITY||||||<|0.001||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||Cumulative incidence model||||<0.001
70895271|NCT00936390|141278701|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||End of RT||||0.38
70895272|NCT00936390|141278701|SUPERIORITY|||||||0.032|||||||t-test, 2 sided|||6 months post-RT||||0.032
70895273|NCT00936390|141278701|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||One year post-RT||||0.87
70895274|NCT00936390|141278701|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||Five years post-RT||||0.67
70895275|NCT00936390|141278702|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||End of RT||||0.58
70895276|NCT00936390|141278702|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||Six months post-RT||||0.31
70895277|NCT00936390|141278702|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||One year post-RT||||0.36
70895278|NCT00936390|141278702|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||Five years post-RT||||0.88
70895279|NCT00936390|141278703|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||End of RT||||<0.001
70895280|NCT00936390|141278703|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Six months post-RT||||<0.001
70895281|NCT00936390|141278703|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||One year post-RT||||<0.001
70895282|NCT00936390|141278703|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Five years post-RT||||0.18
70895283|NCT00936390|141278704|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||End of RT||||<0.001
70895284|NCT00936390|141278704|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Six months post-RT||||<0.001
70895285|NCT00936390|141278704|SUPERIORITY|||||||0.0014|||||||t-test, 2 sided|||One year post-RT||||0.0014
70895286|NCT00936390|141278704|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||Five years post-RT||||0.90
70895287|NCT00936390|141278705|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||End of RT||||0.046
70895288|NCT00936390|141278705|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||6 months post-RT||||0.82
70895289|NCT00936390|141278705|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||One year post-RT||||0.82
70895290|NCT00936390|141278705|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||Five years post-RT||||0.79
70895291|NCT05520138|141278715|SUPERIORITY|With a 2-sided Type I of 0.05 significance.|Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|1.04|1.16|||||A weighted Cox proportional hazard model with an independent variable for treatment group were fitted, using a robust variance estimator.|||1.16|1.04|
70895292|NCT05520138|141278716|SUPERIORITY|With a 2-sided Type I of 0.05 significance.|Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|1.06|1.27|||||A weighted Cox proportional hazard model with an independent variable for treatment group were fitted, using a robust variance estimator.|||1.27|1.06|
70895293|NCT05520138|141278717|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.99|1.1|||||A weighted Cox proportional hazard model with an independent variable for treatment group were fitted, using a robust variance estimator.|||1.10|0.99|
70895294|NCT05520138|141278718|OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|1.06|1.22|||||A weighted Cox proportional hazard model with an independent variable for treatment group were fitted, using a robust variance estimator.|||1.22|1.06|
70895295|NCT00506493|141278719|SUPERIORITY_OR_OTHER_LEGACY||Binomial Proportions|42.6|STANDARD_ERROR_OF_MEAN|6.3|<|0.01|ONE_SIDED|97.5|30.0|||The percent of patients off Class I and III AADs and successfully converted out of AF following treatment (ptest) will exceed the percent of patients off Class I and III AADs and convereted out of AF, as reported in literature (pcontrol=22.1%)|Fisher Exact|||"The specific test hypothesis is as follows:~H0: ptest ≤ 22.1% Ha: ptest \> 22.1%"|||30.0|<0.01
70895296|NCT00506493|141278720|SUPERIORITY_OR_OTHER_LEGACY||binomial proportions|6.7|||<|0.0001|ONE_SIDED|97.5||14.9|||Fisher Exact|||||14.9||<0.0001
70895297|NCT01760239|141278724|SUPERIORITY||Odds Ratio (OR)|4.51|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<.001
70895298|NCT01760239|141278725|SUPERIORITY||Odds Ratio (OR)|2.36||||0.046|TWO_SIDED||||||Mixed Models Analysis|||||||.046
70895299|NCT01760239|141278726|SUPERIORITY||Odds Ratio (OR)|5.13||||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||.001
70895300|NCT01515410|141278740|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-6.86||||0.0471||95.0|-13.62|-0.09||This p-value indicates statistical significance at the 0.05 level.|ANCOVA|No subjects early-terminated from the study.||"Percent OFF Time (%)"||-0.09|-13.62|0.0471
70895301|NCT00868439|141278741|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||< 0.001
70895302|NCT00868439|141278742|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.027|TWO_SIDED||||||Fisher Exact|||||||= 0.027
70895303|NCT00868439|141278743|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.101|TWO_SIDED||||||Fisher Exact|||||||= 0.101
70895304|NCT00868439|141278744|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022|TWO_SIDED||||||Fisher Exact|||||||0.022
70895305|NCT00868439|141278745|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.136|TWO_SIDED||||||Fisher Exact|||||||= 0.136
70895306|NCT00868439|141278746|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.015|TWO_SIDED||||||Fisher Exact|||||||= 0.015
70895307|NCT04109703|141278760|OTHER|The hypothesis is that the high level pulsed heat group will show statistically more pain relief than the low level steady heat group.|||||<|0.05|||||||Regression, Linear|Linear regression was used to compare differences in primary outcome between treatment and control groups adjusting for initial pain level.||Demographic and clinical characteristics were tabulated by randomization group. The primary outcome was change in pain score from baseline to 30 minutes after treatment ended. Linear regression was used to compare differences in primary outcome between treatment and control groups adjusting for initial pain level. Unadjusted comparisons are also presented. Change in pain scores at each other post baseline time point were similarly analyzed.||||<0.05
70895308|NCT02167074|141278767|OTHER|The chi-square test (with Yates' correction when appropriate) or the Fisher exact test was used to compare the two needle types|||||<|0.05|||||||Chi-squared|||||||<0.05
70895309|NCT01043432|141278792|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Regression, Linear|||Linear regressions were utilized to model the outcomes of interest as a function of SA, TBI group, and the interaction between the two groups.||||>.05
70895310|NCT02192502|141278805|NON_INFERIORITY|The non-inferiority delta of a ratio of geometric means is 1.15.|Geometric mean ratio|0.91||||0.15|TWO_SIDED|95.0|0.57|1.44|||generalized linear model|This analysis used linear mixed model with repeated measurements with an unstructured correlation structure.||Assuming that NGAL values follow a log normal distribution as in previous studies with a coefficient of variation of 25%, we need 52 patients per group to have 90% power at the 0.025 significance level to be able to claim non-inferiority of HES to albumin using a non-inferiority delta of a ratio of geometric means of 1.15. After Adjusting for the interim monitoring and five potential dropouts and five pilot patients (which were not included in the analyses), we planned to enroll 140 patients||1.44|0.57|0.15
70895311|NCT02192502|141278806|NON_INFERIORITY|the delta for non-inferiority is 1.15|Risk Ratio (RR)|2.78||||0.92|TWO_SIDED|95.0|0.64|12.1|||Chi-squared|||||12.1|0.64|0.92
70895312|NCT02192502|141278807|NON_INFERIORITY|the non-inferiority delta was 1.15|geometric mean ratio|0.45||||0.002|TWO_SIDED|5.0|0.21|0.95|||Regression, Linear|IL-18 was log-transformed||||0.95|0.21|0.002
70895313|NCT02192502|141278808|NON_INFERIORITY|the delta for non-inferiority is 1.15|geometric mean ratio|0.98||||0.31|TWO_SIDED|95.0|0.45|2.1|||Regression, Linear|IL-18 was log-transformed||||2.10|0.45|0.31
70895314|NCT02192502|141278809|NON_INFERIORITY|The non-inferiority delta was 1.15|Risk Ratio (RR)|0.8|||<|0.001|TWO_SIDED|95.0|0.61|1.03|||Chi-squared|||||1.03|0.61|<0.001
70895315|NCT01869491|141278819|SUPERIORITY||Mean Difference (Final Values)|-0.21|||<|0.0001|TWO_SIDED|95.0|-0.31|-0.11|||Mixed Models Analysis|||||-0.11|-0.31|<0.0001
70895316|NCT01869491|141278820|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.0004|TWO_SIDED|95.0|-0.29|-0.08|||Mixed Models Analysis|||||-0.08|-0.29|0.0004
70895317|NCT01869491|141278821|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.0001|TWO_SIDED|95.0|-0.32|-0.1|||Mixed Models Analysis|||||-0.10|-0.32|0.0001
70895318|NCT01869491|141278822|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.0004|TWO_SIDED|95.0|-0.32|-0.09|||Mixed Models Analysis|||||-0.09|-0.32|0.0004
70895319|NCT01869491|141278823|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
70895320|NCT01869491|141278824|SUPERIORITY|||||||0.0433|||||||Wilcoxon (Mann-Whitney)|||||||0.0433
70895321|NCT01869491|141278825|SUPERIORITY|||||||0.0503|||||||Wilcoxon (Mann-Whitney)|||||||0.0503
70895322|NCT01270347|141278827|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the LS mean difference 95% CI for relative change from Baseline to Day 28 in FEV1 percent predicted was \> -4%.|LSMean difference|1.86||||0.1481|TWO_SIDED|95.0|-0.66|4.39|||ANCOVA||Estimates were determined from an analysis of covariance model with terms for treatment, region (US, non-US), and age (12 to 18 years, \> 18 years), and Baseline FEV1 (\< 55%, . 55%).|||4.39|-0.66|0.1481
70895323|NCT01270347|141278828|NON_INFERIORITY|Non-inferiority is demonstrated if the lower limit of the LS mean difference 95% CI for relative change from baseline to Day 28 in FEV1 percent predicted is \> -4%.|LSMean difference|4.968||||0.083|TWO_SIDED|95.0|-0.653|10.59|||ANCOVA||Estimates are determined from an ANCOVA model with terms for treatment, region (US, non-US), age (12-18 years, \>18 years), baseline FEV1 (\<55%, \>=55%), \& baseline as a covariate.|||10.590|-0.653|0.0830
70895324|NCT01270347|141278829|NON_INFERIORITY|Non-inferiority is demonstrated if the lower limit of the LS mean difference 95% CI for relative change from baseline to Day 28 in FEV1 percent predicted is \> -4%.|LSMean difference|1.57||||0.0945|TWO_SIDED|95.0|-0.272|3.411|||ANCOVA||Estimates are determined from a repeated measures model with terms for treatment, visit, the interaction between treatment group and visit, region (US, non-US), age (12-18 years, \>18 years), baseline FEV1 (\<55%, \>=55%), and baseline as a covariate.|||3.411|-0.272|0.0945
70895325|NCT01270347|141278832|NON_INFERIORITY|Non-inferiority is demonstrated if the lower limit of the LS mean difference 95% CI for relative change from baseline to Day 28 in Pseudomonas Aeruginosa Sputum Density is \> -4%|LSMean difference|0.44||||0.053|TWO_SIDED|95.0|-0.01|0.88|||ANCOVA||Estimates are determined from an ANCOVA model with terms for treatment, region (US, non-US), age (12-18 years, \>18 years), baseline FEV1 (\<55%, \>=55%), and baseline organism log density.|||0.88|-0.01|0.0530
70895326|NCT01270347|141278834|NON_INFERIORITY|Non-inferiority is demonstrated if the lower limit of the LS mean difference 95% CI for relative change from baseline to Day 28 in Respiratory Domain of the CFQ-R is \> -4%|LSMean difference|3.19||||0.0463|TWO_SIDED|95.0|0.05|6.32|||ANCOVA||Estimates are determined from an ANCOVA model with terms for treatment, region (US, non-US), age (12-18 years, \>18 years), baseline FEV1 (\<55%, \>=55%), and baseline value.|||6.32|0.05|0.0463
70895327|NCT02195986|141278844|EQUIVALENCE|Bioequivalence was established for the primary endpoint if the 90% confidence interval for the difference of responder rates (test - reference) from baseline to Day 8 for the primary endpoint is contained within \[-0.20, 0.20\], using the per-protocol population.|Difference|-0.0062|||||TWO_SIDED|90.0|-0.1209|0.1084||||||The compound hypothesis to test was: H0: PT -PR \< -.20 or PT -PR \> .20 versus HA : -.20 ≤ PT -PR ≤ .20 Where PT = cure rate of test treatment, and PR = cure rate of reference treatment.||0.1084|-0.1209|
70895328|NCT02195986|141278845|SUPERIORITY|Superiority test of test product vs placebo|Difference|0.3766|||<|0.0001|TWO_SIDED|95.0|0.2743|0.479|||Chi-squared|||Both the test and reference products should both be statistically superior to placebo (p\<0.05, two-sided) using the Chi squared test with Yate's correction for the primary endpoint responder rate, using the ITT study population and last observation carried forward. The compound hypothesis to test was: H0: PT - PP ≤ 0 versus HA: PT - PP \> 0; Where PT = cure rate of test treatment, and PP = cure rate of placebo.||0.4790|0.2743|<0.0001
70895329|NCT02195986|141278845|SUPERIORITY|Superiority test of reference product vs placebo|Difference|0.3542|||<|0.0001|TWO_SIDED|95.0|0.257|0.4514|||Chi-squared|||Both the test and reference products should both be statistically superior to placebo (p\<0.05, two-sided) using the Chi squared test with Yate's correction for the primary endpoint responder rate, using the ITT study population and last observation carried forward. The compound hypothesis to test was: H0: PT - PP ≤ 0 versus HA: PT - PP \> 0; Where PT = cure rate of test treatment, and PP = cure rate of placebo.||0.4514|0.2570|<0.0001
70895330|NCT02195986|141278846|EQUIVALENCE|Bioequivalence was established for the secondary endpoint if the 90% confidence interval for the difference of responder rates (test - reference) from baseline to Day 8 for the secondary endpoint is contained within \[-0.20, 0.20\], using the per-protocol population.|Difference|0.05|||||TWO_SIDED|90.0|-0.0687|0.1686||||||||0.1686|-0.0687|
70895331|NCT02195986|141278847|SUPERIORITY|Superiority test of test product vs placebo|Difference|0.1387||||0.1092|TWO_SIDED|95.0|-0.028|0.3054|||Chi-squared|||Both the test and reference products should both be statistically superior to placebo (p\<0.05, two-sided) using the Chi squared test with Yate's correction for the secondary endpoint responder rate, using the ITT study population and last observation carried forward. The compound hypothesis to test was: H0: PT - PP ≤ 0 versus HA: PT - PP \> 0; Where PT = cure rate of test treatment, and PP = cure rate of placebo.||0.3054|-0.0280|0.1092
70895332|NCT02195986|141278847|SUPERIORITY|Superiority test of reference product vs placebo|Difference|0.1196||||0.1805|TWO_SIDED|95.0|-0.0491|0.2883|||Chi-squared|||Both the test and reference products should both be statistically superior to placebo (p\<0.05, two-sided) using the Chi squared test with Yate's correction for the secondary endpoint responder rate, using the ITT study population and last observation carried forward. The compound hypothesis to test was: H0: PT - PP ≤ 0 versus HA: PT - PP \> 0; Where PT = cure rate of test treatment, and PP = cure rate of placebo.||0.2883|-0.0491|0.1805
70895333|NCT02491671|141278872|SUPERIORITY||Risk Ratio (RR)|1.219||||0.171|TWO_SIDED|95.0|0.891|1.583|||Chi-squared|||||1.583|0.891|0.171
70895334|NCT02491671|141278873|SUPERIORITY||z|0.288|||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Wilcoxon rank-sum (Mann-Whitney) test Unadjusted variance 274999.00 Adjustment for ties --21069.78 Adjusted variance 253929.22 z = 0.288; Prob \> \|z\| = 0.7735"|||||>0.05
70895335|NCT02491671|141278874|SUPERIORITY||Risk Ratio (RR)|1.351||||0.307|TWO_SIDED|95.0|0.657|1.879|||Chi-squared|||||1.879|0.657|0 .307
70895336|NCT00535730|141278876|NON_INFERIORITY_OR_EQUIVALENCE|The power for the noninferiority hypothesis of VZV antibody titers is 92%. The noninferiority margin is the lower bound of the two-sided 95% confidence interval on the VZV antibody GMT ratio\[concomitant/nonconcomitant\] being \>0.67.||||||0.244||95.0||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|longitudinal regression model|Week 4 postvac, estimated responses, GMT ratio, 95% CI, p-value based on a longitudinal regression model adjusting for prevac titers and age (years)||The hypothesis was that the GMT of the VZV antibody responses at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 will be noninferior to that in subjects who receive ZOSTAVAX™ nonconcomitantly||||0.244
70895337|NCT00535730|141278878|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|t-test, 1 sided|The one-sided p-value for testing acceptability for GMFR is computed based on t-test. CI is computed based on the t distribution||The hypothesis was that ZOSTAVAX™ elicits an acceptable VZV antibody response when administered concomitantly with PNEUMOVAX™ 23.||||<0.001
70895338|NCT00535730|141278879|NON_INFERIORITY_OR_EQUIVALENCE|The power for the noninferiority hypothesis regarding PnPs antibody titer is \~99%. The noninferiority margin is the lower bound of the two-sided 95% confidence interval (CI) on the PnPs antibody GMT ratio \[concomitant/nonconcomitant\] being \>05.|||||<|0.001||95.0||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|longitudinal regression model|Week 4 postvac, estimated responses, GMT ratio, 95% CI, p-value based on a longitudinal regression model adjusting for prevac titers and age (years)||"The hypothesis was that the GMT of the PnPs antibody response to serotype 3 at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 will be noninferior to those in subjects who~receive ZOSTAVAX™ nonconcomitantly."||||<0.001
70895339|NCT00535730|141278880|NON_INFERIORITY_OR_EQUIVALENCE|The power for the noninferiority hypothesis regarding PnPs antibody titer is \~99%. The noninferiority margin is the lower bound of the two-sided 95% confidence interval (CI) on the PnPs antibody GMT ratio \[concomitant/nonconcomitant\] being \>05.|||||<|0.001||95.0||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|longitudinal regression model|Week 4 postvac, estimated responses, GMT ratio, 95% CI, p-value based on a longitudinal regression model adjusting for prevac titers and age (years)||The hypothesis was that the GMT of the PnPs antibody responses to serotype 14 at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 will be noninferior to those in subjects who receive ZOSTAVAX™ nonconcomitantly.||||<0.001
70895340|NCT00535730|141278881|NON_INFERIORITY_OR_EQUIVALENCE|The power for the noninferiority hypothesis regarding PnPs antibody titer is \~99%. The noninferiority margin is the lower bound of the two-sided 95% confidence interval (CI) on the PnPs antibody GMT ratio \[concomitant/nonconcomitant\] being \>05.|||||<|0.001||95.0||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|longitudinal regression model|Week 4 postvac, estimated responses, GMT ratio, 95% CI, p-value based on a longitudinal regression model adjusting for prevac titers and age (years)||The hypothesis was that the GMT of the PnPs antibody responses to serotype 19A at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 will be noninferior to those in subjects who receive ZOSTAVAX™ nonconcomitantly.||||<0.001
70895341|NCT00535730|141278882|NON_INFERIORITY_OR_EQUIVALENCE|The power for the noninferiority hypothesis regarding PnPs antibody titer is \~99%. The noninferiority margin is the lower bound of the two-sided 95% confidence interval (CI) on the PnPs antibody GMT ratio \[concomitant/nonconcomitant\] being \>05.|||||<|0.001||95.0||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|longitudinal regression model|Week 4 postvac, estimated responses, GMT ratio, 95% CI, p-value based on a longitudinal regression model adjusting for prevac titers and age (years)||The hypothesis was that the GMT of the PnPs antibody responses to serotype 22F at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 will be noninferior to those in subjects who receive ZOSTAVAX™ nonconcomitantly.||||<0.001
70895342|NCT05525494|141278883|SUPERIORITY||Adjusted Risk Ratio|0.99|||||TWO_SIDED|95.0|0.98|1.01|||||Adjusted risk ratio. These results compare arms which received portal (any type) reminder/recall messages to the arm receiving no reminder/recall messages (control).|Comparing the risk of receiving an influenza vaccination||1.01|0.98|
70895343|NCT05525494|141278883|SUPERIORITY||Adjusted Risk Ratio|1.0|||||TWO_SIDED|95.0|0.98|1.01|||||Adjusted risk ratio. These results compare arms which received text (any type) reminder/recall messages to the arm receiving no reminder/recall messages (control).|Comparing the risk of receiving an influenza vaccination||1.01|0.98|
70895344|NCT05525494|141278883|SUPERIORITY||Adjusted Risk Ratio|1.01|||||TWO_SIDED|95.0|1.0|1.02|||||Adjusted risk ratio. These results compare arms which received pre-appointment reminder/recall messages (portal and text) to the arm receiving no reminder/recall messages (control).|Comparing the risk of receiving an influenza vaccination||1.02|1.00|
70895345|NCT05525494|141278883|SUPERIORITY||Adjusted Risk Ratio|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||Adjusted risk ratio. These results compare arms which received a tailored reminder/recall messages based on their responses to a pre-commitment questionnaire (any type) to the arm receiving no reminder/recall messages (control).|Comparing the risk of receiving an influenza vaccination||1.01|0.99|
70895346|NCT00762320|141278889|SUPERIORITY_OR_OTHER||||||=|0.004|||||||t-test, 2 sided|df=4||||||=.004
70895347|NCT00762320|141278894|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|df=7||||||<.001
70895348|NCT01055769|141278901|NON_INFERIORITY_OR_EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Linezolid 600 mg oral suspension was the Test treatment, while linezolid 600 mg tablet was the Reference treatment.|Adjusted Geometric Means Ratio|97.81|||||TWO_SIDED|90.0|93.11|102.75||||||Natural log transformed AUClast of linezolid was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||102.75|93.11|
70895349|NCT01055769|141278902|NON_INFERIORITY_OR_EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Linezolid 600 mg oral suspension was the Test treatment, while linezolid 600 mg tablet was the Reference treatment.|Adjusted Geometric Means Ratio|113.67|||||TWO_SIDED|90.0|105.26|122.75||||||Natural log transformed Cmax of linezolid was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||122.75|105.26|
70895350|NCT01055769|141278903|NON_INFERIORITY_OR_EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Linezolid 600 mg oral suspension was the Test treatment, while linezolid 600 mg tablet was the Reference treatment.|Adjusted Geometric means ratio|97.65|||||TWO_SIDED|90.0|92.92|102.63||||||Natural log transformed AUCinf of linezolid was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||102.63|92.92|
70895351|NCT02474927|141278927|OTHER|Descriptive (Pre-Post)||||||0.36|||||||Wilcoxon Signed Rank|||||||0.36
70895352|NCT02474927|141278928|OTHER|Descriptive (pre-post)||||||0.16|||||||Wilcoxon Signed Rank|||||||0.16
70895353|NCT02298192|141278938|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was tested against the alternative hypothesis of non-inferiority as given by H0: D ≥0.30% against HA: D \<0.30%.|Treatment Contrast|0.12||||0.012|TWO_SIDED|95.0|-0.04|0.28|||Mixed Models Analysis|||The null hypothesis was tested against the alternative hypothesis of non-inferiority as given by H0: D ≥0.30% against HA: D \<0.30%.||0.28|-0.04|0.012
70895354|NCT01371851|141278942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0529||||0.05|TWO_SIDED||||||Regression, Logistic|||The analysis was applied to urine data obtained at all time points during weeks 1-8.||||0.05
70895355|NCT00833638|141278943|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||P-value for day \<=4. A fixed-sequence test was used within each dose group at each time point (days 4, 3, 2, 1) and adjusted for multiple dose-placebo comparisons using the Bonferroni method. Testing started on day 4 and stopped when p\>.025.|Regression, Logistic|Model response = treatment + pooled site + severity of erectile dysfunction at baseline.||The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 2.5 mg and placebo as determined by the earliest day on which the cumulative percentage of subjects achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.||||0.086
70895356|NCT00833638|141278943|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value for day \<=4. A fixed-sequence test was used within each dose group at each time point (days 4, 3, 2, 1) and adjusted for multiple dose-placebo comparisons using the Bonferroni method. Testing started on day 4 and stopped when p\>.025.|Regression, Logistic|Model response = treatment + pooled site + severity of erectile dysfunction at baseline.||The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 5 mg and placebo as determined by the earliest day on which the cumulative percentage of participants achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.||||0.006
70895357|NCT00833638|141278943|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-value for day \<=3. A fixed-sequence test was used within each dose group at each time point (days 4, 3, 2, 1) and adjusted for multiple dose-placebo comparisons using the Bonferroni method. Testing started on day 4 and stopped when p\>.025.|Regression, Logistic|Model response = treatment + pooled site + severity of erectile dysfunction at baseline.||The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 5 mg and placebo as determined by the earliest day on which the cumulative percentage of participants achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.||||0.019
70895358|NCT00833638|141278943|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for day \<=2. A fixed-sequence test was used within each dose group at each time point (days 4, 3, 2, 1) and adjusted for multiple dose-placebo comparisons using the Bonferroni method. Testing started on day 4 and stopped when p\>.025.|Regression, Logistic|Model response = treatment + pooled site + severity of erectile dysfunction at baseline.||The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 5 mg and placebo as determined by the earliest day on which the cumulative percentage of participants achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.||||0.022
70895359|NCT00833638|141278943|SUPERIORITY_OR_OTHER|||||||0.573||95.0||||P-value for day \<=1. A fixed-sequence test was used within each dose group at each time point (days 4, 3, 2, 1) and adjusted for multiple dose-placebo comparisons using the Bonferroni method. Testing started on day 4 and stopped when p\>.025.|Regression, Logistic|||The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 5 mg and placebo as determined by the earliest day on which the cumulative percentage of participants achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.||||0.573
70895360|NCT00833638|141278944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.03|||<|0.001|TWO_SIDED|95.0|5.72|18.34||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction were included.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 1 exist between participants who received placebo and participants who received tadalafil 2.5 mg."||18.34|5.72|<0.001
70895361|NCT00833638|141278944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.8|||<|0.001|TWO_SIDED|95.0|6.48|19.12||No adjustment for multiplicity.|ANCOVA|Terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction were included.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 1 exist between participants who received placebo and participants who received tadalafil 5 mg."||19.12|6.48|<0.001
70895362|NCT00833638|141278945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.4|||<|0.001|TWO_SIDED|95.0|8.51|22.29||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 2 exist between participants who received placebo and participants who received tadalafil 2.5 mg."||22.29|8.51|<0.001
70895363|NCT00833638|141278945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.41|||<|0.001|TWO_SIDED|95.0|13.5|27.31||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 2 exist between participants who received placebo and participants who received tadalafil 5 mg."||27.31|13.50|<0.001
70895364|NCT00833638|141278946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.27|||<|0.001|TWO_SIDED|95.0|6.83|21.71||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 3 exist between participants who received placebo and participants who received tadalafil 2.5 mg."||21.71|6.83|<0.001
70895365|NCT00833638|141278946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.54|||<|0.001|TWO_SIDED|95.0|13.07|28.01||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 3 exist between participants who received placebo and participants who received tadalafil 5 mg."||28.01|13.07|<0.001
70895366|NCT00833638|141278947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.24|||<|0.001|TWO_SIDED|95.0|6.42|22.06||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 4 exist between participants who received placebo and participants who received tadalafil 2.5 mg."||22.06|6.42|<0.001
70895367|NCT00833638|141278947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.81|||<|0.001|TWO_SIDED|95.0|13.94|29.67||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 4 exist between participants who received placebo and participants who received tadalafil 5 mg."||29.67|13.94|<0.001
70895368|NCT00833638|141278948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.92|||<|0.001|TWO_SIDED|95.0|6.3|21.55||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 5 exist between participants who received placebo and participants who received tadalafil 2.5 mg."||21.55|6.30|<0.001
70895369|NCT00833638|141278948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.07|||<|0.001|TWO_SIDED|95.0|11.4|26.75||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 5 exist between participants who received placebo and participants who received tadalafil 5 mg."||26.75|11.40|<0.001
70895370|NCT00833638|141278949|SUPERIORITY_OR_OTHER|||||||0.301||95.0||||No adjustment for multiplicity.|Log Rank|||"Tested was the null-hypothesis that no differences in the time to onset of efficacy exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.301
70895371|NCT00833638|141278949|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||No adjustment for multiplicity.|Log Rank|||"Tested was the null-hypothesis that no differences in the time to onset of efficacy exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.046
70895372|NCT00833638|141278950|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=14. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
70895373|NCT00833638|141278950|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=13. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
70895374|NCT00833638|141278950|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=12. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
70895375|NCT00833638|141278950|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=11. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
70895376|NCT00833638|141278950|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=10. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
70895377|NCT00833638|141278950|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=9. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
70895378|NCT00833638|141278950|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for day \<=8. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.002
70895379|NCT00833638|141278950|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for day \<=7. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.001
70895380|NCT00833638|141278950|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for day \<=6. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.002
70895381|NCT00833638|141278950|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for day \<=5. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.002
70895382|NCT00833638|141278950|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for day \<=4. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.002
70895383|NCT00833638|141278950|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for day \<=3. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.009
70895384|NCT00833638|141278950|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||P-value for day \<=2. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.038
70895385|NCT00833638|141278950|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=14. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the proportion of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
70895386|NCT00833638|141278950|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=13. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
70895387|NCT00833638|141278950|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=12. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
70895388|NCT00833638|141278950|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=11. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
70895389|NCT00833638|141278950|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=10. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
70895390|NCT00833638|141278950|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=9. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
70895391|NCT00833638|141278950|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=8. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
70895392|NCT00833638|141278950|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=7. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
70895393|NCT00833638|141278950|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=6. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
70895394|NCT00833638|141278950|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=5. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
70895395|NCT00833638|141278950|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=4. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
70895396|NCT00833638|141278950|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for day \<=3. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.003
70895397|NCT00833638|141278950|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value for day \<=2. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.008
70895398|NCT00833638|141278950|SUPERIORITY_OR_OTHER|||||||0.246||95.0||||P-value for day \<=1. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.246
70895399|NCT00833638|141278951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.05|||<|0.001||95.0|||||t-test, 2 sided||the estimated mean difference shows changes in the double-blind treatment phase minus changes in the open label treatment phase|"Tested was the null-hypothesis that no differences in the proportion of successful intercourse attempts exist in patients who received placebo in the double-blind treatment period when comparing their proportion of succesful intercourse attempts between the double-blind treatment period (while receiving placebo) and the open-label treatment period (while receiving tadalafil 5 mg), measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
70895400|NCT00833638|141278952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.22|||<|0.001||95.0|||||t-test, 2 sided||the estimated mean difference shows changes in the double-blind treatment phase minus changes in the open label treatment phase|"Tested was the null-hypothesis that no differences in the proportion of successful intercourse attempts exist in patients who received tadalafil 2.5 mg in the double-blind treatment period when comparing their proportion of succesful intercourse attempts between the double-blind treatment period (while receiving tadalafil 2.5 mg) and the open-label treatment period (while receiving tadalafil 5 mg), measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
70895401|NCT00833638|141278953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.16|||<|0.001||95.0|||||t-test, 2 sided||the estimated mean difference shows changes in the double-blind treatment phase minus changes in the open label treatment phase|"Tested was the null-hypothesis that no differences in the proportion of successful intercourse attempts exist in patients who received tadalfil 5 mg in the double-blind treatment period when comparing their proportion of succesful intercourse attempts between the double-blind treatment period (while receiving tadalafil 5 mg) and the open-label treatment period (while receiving tadalafil 5 mg), measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
70895402|NCT00833638|141278954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.11|||<|0.001||95.0|||||t-test, 2 sided||the estimated mean difference shows changes in the double-blind treatment phase minus changes in the open label treatment phase|"Tested was the null-hypothesis that no differences in the percentages of successful intercourse attempts exist in participants who received tadalafil 2.5 mg in the double-blind treatment period and did not respond to treatment when comparing their percentage of succesful intercourse attempts between the double-blind treatment period and the open-label treatment period (while receiving tadalafil 5 mg), measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
70895403|NCT01669122|141278955|NON_INFERIORITY_OR_EQUIVALENCE|Testing Bioequivalence|Treatment Ratio|0.96|||||TWO_SIDED|90.0|0.93|0.99||||||Null hypothesis considered no difference in the treatments being compared.||0.99|0.93|
70895404|NCT01669122|141278955|NON_INFERIORITY_OR_EQUIVALENCE|Testing Bioequivalence|Treatment Ratio|0.96|||||TWO_SIDED|90.0|0.93|0.99||||||Null hypothesis considered no difference in the treatments being compared.||0.99|0.93|
70895405|NCT01669122|141278955|NON_INFERIORITY_OR_EQUIVALENCE|Testing Bioequivalence|Treatment Ratio|0.94|||||TWO_SIDED|90.0|0.91|0.97||||||Null hypothesis considered no difference in the treatments being compared.||0.97|0.91|
70895406|NCT01669122|141278956|NON_INFERIORITY_OR_EQUIVALENCE|Testing bioequivalence|Treatment Ratio|0.97|||||TWO_SIDED|90.0|0.93|1.02||||||Null hypothesis considered no difference in the treatments being compared.||1.02|0.93|
70895407|NCT01669122|141278956|NON_INFERIORITY_OR_EQUIVALENCE|Testing Bioequivalence|Treatment Ratio|0.99|||||TWO_SIDED|90.0|0.94|1.03||||||Null hypothesis considered no difference in the treatments being compared.||1.03|0.94|
70895408|NCT01669122|141278956|NON_INFERIORITY_OR_EQUIVALENCE|Testing Bioequivalence|Treatment Ratio|0.92|||||TWO_SIDED|90.0|0.88|0.96||||||Null hypothesis considered no difference in the treatments being compared.||0.96|0.88|
70895409|NCT01669122|141278957|NON_INFERIORITY_OR_EQUIVALENCE|Testing bioequivalence|Treatment Ratio|0.96|||||TWO_SIDED|90.0|0.93|0.99||||||Null hypothesis considered no difference in the treatments being compared.||0.99|0.93|
70895410|NCT01669122|141278957|NON_INFERIORITY_OR_EQUIVALENCE|Testing bioequivalence|Treatment Ratio|0.96|||||TWO_SIDED|90.0|0.93|0.99||||||Null hypothesis considered no difference in the treatments being compared.||0.99|0.93|
70895411|NCT01669122|141278957|NON_INFERIORITY_OR_EQUIVALENCE|Testing bioequivalence|Treatment Ratio|0.93|||||TWO_SIDED|90.0|0.9|0.96||||||Null hypothesis considered no difference in the treatments being compared.||0.96|0.90|
70895412|NCT01669122|141278958|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.2208|TWO_SIDED|95.0|0.0|0.5|||Wilcoxon (Mann-Whitney)||Based on Hodges Lehmann estimate|Null hypothesis considered no difference in the treatments being compared.||0.50|0.00|0.2208
70895413|NCT01669122|141278958|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.5695|TWO_SIDED|95.0|-0.25|0.25|||Wilcoxon (Mann-Whitney)||Based on Hodges Lehmann estimate|Null hypothesis considered no difference in the treatments being compared.||0.25|-0.25|0.5695
70895414|NCT01669122|141278958|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0063|TWO_SIDED|95.0|0.0|0.5|||Wilcoxon (Mann-Whitney)||Based on Hodges Lehmann estimate|Null hypothesis considered no difference in the treatments being compared.||0.50|0.00|0.0063
70895415|NCT00234065|141278965|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% CI limit for the HR of cilostazol to aspirin was 1.33 (4/3) or lower , cilostazol would be non-inferior to aspirin.|Hazard Ratio, log|0.743||||0.0357|TWO_SIDED|95.0|0.564|0.981||The log-rank test was used to verify the superiority of CLZ to ASA only if non-inferiority was verified. The adjusted significance level for the superiority test of the endpoint was set at 0.0471 (two-tailed) according to the O'Brien-Fleming method.|Log Rank|||Statistical Analysis 1 for Number of Patients With First Occurrence of Stroke||0.981|0.564|0.0357
70895416|NCT00234065|141278966|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.88||||0.4189|TWO_SIDED|95.0|0.645|1.2|||Log Rank|||Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.||1.200|0.645|0.4189
70895417|NCT00234065|141278967|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.898||||0.4582|TWO_SIDED|95.0|0.675|1.194|||Log Rank|||Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.||1.194|0.675|0.4582
70895418|NCT00234065|141278968|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.072||||0.86|TWO_SIDED|95.0|0.497|2.313|||Log Rank|||Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.||2.313|0.497|0.8600
70895419|NCT00234065|141278969|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.799||||0.0437|TWO_SIDED|95.0|0.643|0.994|||Log Rank|||Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.||0.994|0.643|0.0437
70895420|NCT00234065|141278970|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.458||||0.0004|TWO_SIDED|95.0|0.296|0.711|||Log Rank|||Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.||0.711|0.296|0.0004
70895421|NCT02477618|141278983|SUPERIORITY||Odds Ratio (OR)|1.056||||0.878|TWO_SIDED|95.0|0.527|2.118|||Regression, Logistic|||||2.118|0.527|0.878
70895422|NCT02477618|141278984|SUPERIORITY||Hazard Ratio (HR)|0.747||||0.636|TWO_SIDED|95.0|0.222|2.507|||Regression, Cox|||||2.507|0.222|0.636
70895423|NCT02477618|141278985|SUPERIORITY||Odds Ratio (OR)|0.623||||0.199|TWO_SIDED|95.0|0.303|1.282|||Regression, Logistic|||||1.282|0.303|0.199
70895424|NCT02477618|141278986|SUPERIORITY||Hazard Ratio (HR)|0.683||||0.328|TWO_SIDED|95.0|0.318|1.466|||Regression, Cox|||||1.466|0.318|0.328
70895425|NCT02477618|141278988|SUPERIORITY||Hazard Ratio (HR)|0.583||||0.339|TWO_SIDED|95.0|0.193|1.763|||Regression, Cox|||||1.763|0.193|0.339
70895426|NCT02477618|141278989|SUPERIORITY||Hazard Ratio (HR)|1.086||||0.817|TWO_SIDED|95.0|0.539|2.189|||Regression, Cox|||||2.189|0.539|0.817
70895427|NCT02477618|141278990|SUPERIORITY||LS Mean Difference|-0.2||||0.567|TWO_SIDED|95.0|-0.9|0.5|||ANCOVA|||||0.5|-0.9|0.567
70895428|NCT05540522|141279005|OTHER||RVE|34.5|||||TWO_SIDED|95.0|7.4|53.9||||||||53.9|7.4|
70895429|NCT05540522|141279006|OTHER||RVE|-5.8|||||TWO_SIDED|95.0|-47.2|23.8||||||||23.8|-47.2|
70895430|NCT05540522|141279027|OTHER||GMR|1.23|||||TWO_SIDED|95.0|1.1|1.38||||||A/H3N2||1.38|1.10|
70895431|NCT05540522|141279027|OTHER||GMR|1.24|||||TWO_SIDED|95.0|1.1|1.39||||||A/H1N1||1.39|1.10|
70895432|NCT05540522|141279027|OTHER||GMR|0.73|||||TWO_SIDED|95.0|0.67|0.8||||||B/Yamagata||0.80|0.67|
70895433|NCT05540522|141279027|OTHER||GMR|0.3|||||TWO_SIDED|95.0|0.26|0.35||||||B/Victoria||0.35|0.26|
70895434|NCT05540522|141279028|OTHER||GMR|1.65|||||TWO_SIDED|95.0|1.47|1.84||||||A/H3N2||1.84|1.47|
70895435|NCT05540522|141279028|OTHER||GMR|1.71|||||TWO_SIDED|95.0|1.51|1.92||||||A/H1N1||1.92|1.51|
70895436|NCT05540522|141279028|OTHER||GMR|1.04|||||TWO_SIDED|95.0|0.95|1.14||||||B/Yamagata||1.14|0.95|
70895437|NCT05540522|141279028|OTHER||GMR|0.61|||||TWO_SIDED|95.0|0.54|0.69||||||B/Victoria||0.69|0.54|
70895438|NCT05540522|141279029|OTHER||Difference in percentage|11.4|||||TWO_SIDED|95.0|6.4|16.4||||||A/H3N2: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||16.4|6.4|
70895439|NCT05540522|141279029|OTHER||Difference in percentage|13.6|||||TWO_SIDED|95.0|8.6|18.6||||||A/H1N1: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||18.6|8.6|
70895440|NCT05540522|141279029|OTHER||Difference in percentage|-15.3|||||TWO_SIDED|95.0|-19.5|-11.2||||||B/Yamagata: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||-11.2|-19.5|
70895441|NCT05540522|141279029|OTHER||Difference in percentage|-40.5|||||TWO_SIDED|95.0|-44.7|-36.1||||||B/Victoria: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||-36.1|-44.7|
70895442|NCT05540522|141279030|OTHER||Difference in percentage|21.6|||||TWO_SIDED|95.0|16.7|26.5||||||A/H3N2: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||26.5|16.7|
70895443|NCT05540522|141279030|OTHER||Difference in percentage|25.7|||||TWO_SIDED|95.0|20.9|30.4||||||A/H1N1: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||30.4|20.9|
70895444|NCT05540522|141279030|OTHER||Difference in percentage|-2.1|||||TWO_SIDED|95.0|-4.8|0.6||||||B/Yamagata: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||0.6|-4.8|
70895445|NCT05540522|141279030|OTHER||Difference in percentage|-22.6|||||TWO_SIDED|95.0|-26.7|-18.5||||||B/Victoria: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||-18.5|-26.7|
70895446|NCT05540522|141279031|OTHER||GMR|1.92|||||TWO_SIDED|95.0|1.78|2.07||||||A/H3N2||2.07|1.78|
70895447|NCT05540522|141279031|OTHER||GMR|1.68|||||TWO_SIDED|95.0|1.55|1.82||||||A/H1N1||1.82|1.55|
70895448|NCT05540522|141279031|OTHER||GMR|0.88|||||TWO_SIDED|95.0|0.82|0.94||||||B/Yamagata||0.94|0.82|
70895449|NCT05540522|141279031|OTHER||GMR|0.58|||||TWO_SIDED|95.0|0.53|0.63||||||B/Victoria||0.63|0.53|
70895450|NCT05540522|141279032|OTHER||GMR|2.38|||||TWO_SIDED|95.0|2.23|2.54||||||A/H3N2||2.54|2.23|
70895451|NCT05540522|141279032|OTHER||GMR|2.37|||||TWO_SIDED|95.0|2.22|2.54||||||A/H1N1||2.54|2.22|
70895452|NCT05540522|141279032|OTHER||GMR|1.36|||||TWO_SIDED|95.0|1.29|1.43||||||B/Yamagata||1.43|1.29|
70895453|NCT05540522|141279032|OTHER||GMR|0.76|||||TWO_SIDED|95.0|0.71|0.81||||||B/Victoria||0.81|0.71|
70895454|NCT05540522|141279033|OTHER||Difference in Percentage|26.8|||||TWO_SIDED|95.0|23.7|29.9||||||A/H3N2: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||29.9|23.7|
70895455|NCT05540522|141279033|OTHER||Difference in Percentage|26.9|||||TWO_SIDED|95.0|23.9|29.8||||||A/H1N1: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||29.8|23.9|
70895456|NCT05540522|141279033|OTHER||Difference in Percentage|-3.6|||||TWO_SIDED|95.0|-6.6|-0.6||||||B/Yamagata: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||-0.6|-6.6|
70895457|NCT05540522|141279033|OTHER||Difference in Percentage|-19.2|||||TWO_SIDED|95.0|-21.9|-16.6||||||B/Victoria: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||-16.6|-21.9|
70895458|NCT05540522|141279034|OTHER||Difference in Percentage|37.9|||||TWO_SIDED|95.0|35.2|40.5||||||A/H3N2: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||40.5|35.2|
70895459|NCT05540522|141279034|OTHER||Difference in Percentage|44.9|||||TWO_SIDED|95.0|42.4|47.4||||||A/H1N1: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||47.4|42.4|
70895460|NCT05540522|141279034|OTHER||Difference in Percentage|10.6|||||TWO_SIDED|95.0|8.5|12.8||||||B/Yamagata: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||12.8|8.5|
70895461|NCT05540522|141279034|OTHER||Difference in Percentage|-13.8|||||TWO_SIDED|95.0|-16.3|-11.3||||||B/Victoria: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||-11.3|-16.3|
70895462|NCT00857207|141279105|SUPERIORITY||Mean Difference (Final Values)|-3.95|STANDARD_ERROR_OF_MEAN|1.14||0.0004|TWO_SIDED|95.0|||||Regression, Linear|dependent variable: post-treatment outcome; independent variables:pre-treatment measurement and group indicator.||Linear regression of change of cTOL time to first move in GMT versus BHW group||||0.0004
70895463|NCT00857207|141279105|SUPERIORITY||Mean Difference (Final Values)|-2.92|STANDARD_DEVIATION|3.55||0.012|TWO_SIDED|95.0|||||t-test, 2 sided|||total time will significantly improve 10 weeks from post||||0.012
70895464|NCT00857207|141279105|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|2.04||0.98|TWO_SIDED|95.0|||||t-test, 2 sided|||Time to first move will significantly increase at 10 weeks from baseline to indicate better planning||||0.98
70895465|NCT00857207|141279106|SUPERIORITY||Mean Difference (Final Values)|2.64|STANDARD_DEVIATION|6.42||0.15|TWO_SIDED|95.0|||||t-test, 2 sided|||paired T-test, Behavioral Regulation Index will improve at week 10 from baseline||||0.15
70895466|NCT00857207|141279106|SUPERIORITY||Mean Difference (Final Values)|2.79|STANDARD_DEVIATION|8.4||0.24|TWO_SIDED|95.0|||||t-test, 2 sided|||paired t-test of Metacognitive Index, MI will improve at 10 weeks compared to baseline.||||0.24
70895467|NCT00857207|141279107|SUPERIORITY||Median Difference (Final Values)|0.03|STANDARD_DEVIATION|0.09||0.3|TWO_SIDED|95.0|||||t-test, 2 sided|||optimal moves will significantly increase at 10 weeks from baseline||||0.30
70895468|NCT03035292|141279115|SUPERIORITY||||||<|0.05||||||This value of \<0.05 is the calculated p value where the a priori threshold for statistical significance is considered to be p=0.05.|McNemar|||Sample size was based on a cataract prevalence of 20% in the enriched population and a predicted difference of 15% sensitivity and specificity between tests.||||<0.05
70895469|NCT03035292|141279117|SUPERIORITY||||||<|0.05||||||The calculated p value was \<0.05. A priori threshold for statistical significance is p=0.05|Fisher Exact|||Evidence of superiority of intervention 2 over intervention 1 requires a significant difference in specificity of the intervention 1 and 2 between ethnicity groups.||||<0.05
70895470|NCT00447057|141279118|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63||||0.0047|TWO_SIDED|95.0|0.438|0.897|||Log Rank|Log-rank test with 1-sided alpha of 0.20||||0.897|0.438|0.0047
70895471|NCT00447057|141279119|SUPERIORITY_OR_OTHER|||||||0.3909|||||||Fisher Exact|||||||0.3909
70895472|NCT00447057|141279120|SUPERIORITY_OR_OTHER|||||||0.1808|||||||Fisher Exact|||||||0.1808
70895473|NCT00447057|141279121|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.0034|TWO_SIDED|95.0|0.457|0.887||1-sided significance level of 0.20|Log Rank|||||0.887|0.457|0.0034
70895474|NCT00447057|141279122|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.019|TWO_SIDED|95.0|0.465|0.981||1-sided significance level of 0.20|Log Rank|||||0.981|0.465|0.0190
70895475|NCT00440531|141279125|SUPERIORITY_OR_OTHER||single-group percentage|75.7||||||95.0|68.0|82.2||||||No hypothesis is being tested. The purpose of the primary analysis is to estimate the seroprotection rate (percentage of subjects with anti-HBs \>=10mIU/mL) in each group at 1 month post vaccination 3, among subjects who were seronegative at baseline.||82.20|68|
70895476|NCT00440531|141279125|SUPERIORITY_OR_OTHER||single-group percentage|68.0||||||95.0|59.8|75.5||||||No hypothesis is being tested. The purpose of the primary analysis is to estimate the seroprotection rate (percentage of subjects with anti-HBs \>=10mIU/mL) in each group at 1 month post vaccination 3, among subjects who were seronegative at baseline.||75.50|59.80|
70895477|NCT00440531|141279126|SUPERIORITY_OR_OTHER||Single-Group Percentage|84.0||||||95.0|77.0|89.6||||||No hypothesis is being tested. The purpose of the secondary analysis is to estimate the seroprotection rate (percentage of subjects with anti-HBs \>=10mIU/mL) for ENGERIX-B™ at 1 month post vaccination 3, among subjects who were seronegative at baseline.||89.60|77|
70895478|NCT05090709|141279151|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||Stiffness values were analysed as a percentage change from baseline measurements to normalise group variances.||||> 0.05
70895479|NCT05090709|141279151|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||Stiffness values were analysed as a percentage change from baseline measurements to normalise group variances.||||> 0.05
70895480|NCT05090709|141279156|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||< 0.05
70895481|NCT05090709|141279156|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||< 0.05
70895482|NCT05090709|141279161|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||Sit-to-stand velocity values were analysed as a percentage change from baseline measurements to normalise group variances.||||> 0.05
70895483|NCT05090709|141279161|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||Sit-to-stand velocity values were analysed as a percentage change from baseline measurements to normalise group variances.||||> 0.05
70895484|NCT05090709|141279166|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
70895485|NCT05090709|141279166|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
70895486|NCT05090709|141279168|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including both time points in the analysis.||||||< 0.05
70895487|NCT05090709|141279168|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including both time points in the analysis.||||||> 0.05
70895488|NCT05090709|141279173|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||Muscle tone values were analysed as a percentage change from baseline measurements to normalise group variances.||||> 0.05
70895489|NCT05090709|141279173|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||Muscle tone values were analysed as a percentage change from baseline measurements to normalise group variances.||||> 0.05
70895490|NCT05090709|141279178|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
70895491|NCT05090709|141279178|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
70895492|NCT05090709|141279183|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
70895493|NCT05090709|141279183|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
70895494|NCT05090709|141279188|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||< 0.05
70895495|NCT05090709|141279188|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
70895496|NCT05090709|141279193|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
70895497|NCT05090709|141279193|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||< 0.05
70895498|NCT05090709|141279198|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
70895499|NCT05090709|141279198|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
70895500|NCT05090709|141279203|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||< 0.05
70895501|NCT05090709|141279203|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||< 0.05
70895502|NCT02131272|141279221|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered fulfilled if the upper bound of the two-sided 95% confidence interval for the difference between detemir and NPH was below or equal to 0.4%. The sample size was set to ensure 80% power for the full analysis set (FAS). However, efficacy conclusions cannot be drawn from the analysis due to low number of subjects included in the trial.|Least squares mean difference|0.17||||0.3075|TWO_SIDED|95.0|-0.74|1.09||p value is reported for 1 sided test|Mixed Models Analysis|||HbA1c measurements were analysed with a mixed model for repeated measurements with an unstructured covariance matrix. The model included treatment, visit, age group, prior antidiabetic therapy and interaction between prior antidiabetic therapy and age group as fixed factors and the HbA1c baseline value as covariate. Interactions between visit and all factors and covariates were also included in the model.||1.09|-0.74|0.3075
70895503|NCT01786512|141279249|OTHER||Treatment difference|0.0112|STANDARD_ERROR_OF_MEAN|0.0033||0.0007|TWO_SIDED|95.0|0.0047|0.0176|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||0.0176|0.0047|0.0007
70895504|NCT01786512|141279249|OTHER||Treatment difference|0.025|STANDARD_ERROR_OF_MEAN|0.0033|<|0.0001|TWO_SIDED|95.0|0.0184|0.0315|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||0.0315|0.0184|<0.0001
70895505|NCT01786512|141279250|OTHER||Treatment difference|4.58|STANDARD_ERROR_OF_MEAN|1.56||0.0036|TWO_SIDED|95.0|1.5|7.65|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||7.65|1.50|0.0036
70895506|NCT01786512|141279250|OTHER||Treatment difference|3.63|STANDARD_ERROR_OF_MEAN|1.57||0.0217|TWO_SIDED|95.0|0.53|6.72|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||6.72|0.53|0.0217
70895507|NCT01786512|141279251|OTHER||Treatment difference|-0.079|STANDARD_ERROR_OF_MEAN|0.058||0.1732|TWO_SIDED|95.0|-0.194|0.035|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||0.035|-0.194|0.1732
70895508|NCT01786512|141279251|OTHER||Treatment difference|-0.179|STANDARD_ERROR_OF_MEAN|0.059||0.0027|TWO_SIDED|95.0|-0.295|-0.062|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||-0.062|-0.295|0.0027
70895509|NCT01786512|141279252|OTHER||Treatment difference|-0.067|STANDARD_ERROR_OF_MEAN|0.051||0.1899|TWO_SIDED|95.0|-0.166|0.033|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||0.033|-0.166|0.1899
70895510|NCT01786512|141279252|OTHER||Treatment difference|-0.129|STANDARD_ERROR_OF_MEAN|0.052||0.0128|TWO_SIDED|95.0|-0.231|-0.028|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||-0.028|-0.231|0.0128
70895511|NCT01786512|141279253|OTHER||Treatment difference|-1.34|STANDARD_ERROR_OF_MEAN|1.09||0.2177|TWO_SIDED|95.0|-3.47|0.79|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||0.79|-3.47|0.2177
70895512|NCT01786512|141279253|OTHER||Treatment difference|-2.97|STANDARD_ERROR_OF_MEAN|1.09||0.007|TWO_SIDED|95.0|-5.12|-0.81|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||-0.81|-5.12|0.0070
70895513|NCT01786512|141279254|OTHER||Treatment difference|-822.0|STANDARD_ERROR_OF_MEAN|353.0||0.0205|TWO_SIDED|95.0|-1516.0|-127.0|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||-127|-1516|0.0205
70895514|NCT01786512|141279254|OTHER||Treatment difference|-970.0|STANDARD_ERROR_OF_MEAN|357.0||0.0069|TWO_SIDED|95.0|-1672.0|-268.0|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||-268|-1672|0.0069
70895515|NCT00605293|141279268|SUPERIORITY_OR_OTHER|||||||0.4778|||||||Fisher Exact|||||||0.4778
70895516|NCT02858050|141279286|OTHER|||||||0.548306|||||||Chi-squared|||||||0.548306
70895517|NCT03561090|141279287|SUPERIORITY||Least squares (LS) mean difference|0.055||||0.6346|TWO_SIDED|95.0|-0.172|0.281|||MMRM||Treatment difference (IW-3718 - placebo)|Treatment difference calculated as least squares mean (LSM) change from baseline at Week 8; IW-3718 - placebo based on an mixed models repeated measures (MMRM) model with week (categorical), treatment group, week-by-treatment group, and week-by-baseline value interactions, baseline esophagitis status (present vs. not present), and baseline WHSS (\< 3 vs. ≥ 3) as fixed effect terms and baseline value as a covariate, with subject as a random effect. An unstructured covariance structure was used.||0.281|-0.172|0.6346
70895518|NCT03561090|141279288|SUPERIORITY||LS Mean Difference|0.035||||0.7101|TWO_SIDED|95.0|-0.151|0.221|||MMRM||Treatment difference (IW-3718 - placebo)|Treatment difference calculated as LSM change from baseline at Week 8; IW-3718 - placebo based on an MMRM model with week (categorical), treatment group, week-by-treatment group, and week-by-baseline value interactions, baseline esophagitis status (present vs. not present), and baseline WHSS (\< 3 vs. ≥ 3) as fixed effect terms and baseline value as a covariate, with subject as a random effect. An unstructured covariance structure was used.||0.221|-0.151|0.7101
70895519|NCT03561090|141279289|SUPERIORITY||Difference in percentage of responders|-5.5|||||TWO_SIDED|95.0|-14.7|3.7|||||95% confidence interval (CI) for Difference in Responder Rates is obtained using the Newcombe CI.|||3.7|-14.7|
70895520|NCT03561090|141279289|SUPERIORITY||Odds Ratio (OR)|0.81||||0.2531|TWO_SIDED|95.0|0.56|1.17|||Cochran-Mantel-Haenszel||Odds Ratio for Response (IW-3718 : placebo)|Treatment difference was calculated as the difference in the responder rates at Week 8; IW-3718 - placebo. The 95% CI for the difference in the responder rates was obtained using the Newcombe CI. P value was based on the odds ratio for the response rate (IW-3718:placebo) obtained from the CMH tests controlling for baseline esophagitis status and baseline heartburn severity level (\< 3 vs. ≥ 3).||1.17|0.56|0.2531
70895521|NCT03561090|141279290|SUPERIORITY||Proportion ratio|0.938||||0.7445|TWO_SIDED|95.0|0.636|1.382||Negative binomial model was used to deal with data overdispersion.|Negative binomial model||Proportion Ratio (1500 mg IW-3718 BID + PPI: Placebo + PPI)|Poisson regression including the fixed categorical effect of treatment, the baseline esophagitis status (present vs. not present) and baseline WHSS (\<3 vs. ≥3), the covariate of baseline proportion of heartburn-free days, and with the diary entry duration (in days) as a weight variable adjusted in the model was applied.||1.382|0.636|0.7445
70895522|NCT03561090|141279290|OTHER|Negative binomial model was used to deal with data overdispersion.|Difference in Proportion Ratio|-0.015|||||TWO_SIDED|95.0|-0.103|0.074|||||Difference in Proportion Ratio, (1500 mg IW-3718 BID + PPI) - (Placebo + PPI).|Poisson regression including the fixed categorical effect of treatment, the baseline esophagitis status (present vs. not present) and baseline WHSS (\<3 vs. ≥3), the covariate of baseline proportion of heartburn-free days, and with the diary entry duration (in days) as a weight variable adjusted in the model was applied.||0.074|-0.103|
70895523|NCT04162769|141279292|SUPERIORITY||Least square mean difference|-10.28|STANDARD_ERROR_OF_MEAN|6.605|=|0.1198|TWO_SIDED|95.0|-23.228|2.674|||ANCOVA|||Week 12||2.674|-23.228|=0.1198
70895524|NCT04162769|141279292|SUPERIORITY||Least square mean difference|-8.77|STANDARD_ERROR_OF_MEAN|6.515|=|0.1783|TWO_SIDED|95.0|-21.544|4.002|||ANCOVA|||Week 12||4.002|-21.544|=0.1783
70895525|NCT04162769|141279293|SUPERIORITY||Response Rate Difference|-0.2|STANDARD_ERROR_OF_MEAN|9.34|=|0.9826|TWO_SIDED|95.0|-18.52|18.11|||Cochran-Mantel-Haenszel|||Week 12||18.11|-18.52|=0.9826
70895526|NCT04162769|141279293|SUPERIORITY||Response Rate Difference|13.0|STANDARD_ERROR_OF_MEAN|9.78|=|0.1891|TWO_SIDED|95.0|-6.12|32.21|||Cochran-Mantel-Haenszel|||Week 12||32.21|-6.12|=0.1891
70895527|NCT04162769|141279294|SUPERIORITY||Response Rate Difference|2.2|STANDARD_ERROR_OF_MEAN|7.38|=|0.7694|TWO_SIDED|95.0|-12.29|16.64|||Cochran-Mantel-Haenszel|||Week 12||16.64|-12.29|=0.7694
70895528|NCT04162769|141279294|SUPERIORITY||Response Rate Difference|17.4|STANDARD_ERROR_OF_MEAN|8.47|=|0.045|TWO_SIDED|95.0|0.79|34.0|||Cochran-Mantel-Haenszel|||Week 12||34.00|0.79|=0.0450
70895529|NCT04162769|141279295|SUPERIORITY||Least square mean difference|-14.03|STANDARD_ERROR_OF_MEAN|7.295|=|0.0558|TWO_SIDED|95.0|-28.406|0.352|||Mixed Models Analysis|||Week 12||0.352|-28.406|=0.0558
70895530|NCT04162769|141279295|SUPERIORITY||Least square mean difference|-10.67|STANDARD_ERROR_OF_MEAN|7.134|=|0.1363|TWO_SIDED|95.0|-24.737|3.397|||Mixed Models Analysis|||Week 12||3.397|-24.737|=0.1363
70895531|NCT04162769|141279296|SUPERIORITY||Response Rate Difference|4.2|STANDARD_ERROR_OF_MEAN|11.33|=|0.7143|TWO_SIDED|95.0|-18.0|26.41|||Cochran-Mantel-Haenszel|||Week 12||26.41|-18.00|=0.7143
70895532|NCT04162769|141279296|SUPERIORITY||Response Rate Difference|5.1|STANDARD_ERROR_OF_MEAN|11.09|=|0.6488|TWO_SIDED|95.0|-16.62|26.87|||Cochran-Mantel-Haenszel|||Week 12||26.87|-16.62|=0.6488
70895533|NCT04162769|141279297|SUPERIORITY||Response Rate Difference|8.8|STANDARD_ERROR_OF_MEAN|10.22|=|0.3981|TWO_SIDED|95.0|-11.27|28.8|||Cochran-Mantel-Haenszel|||Week 12||28.80|-11.27|=0.3981
70895534|NCT04162769|141279297|SUPERIORITY||Response Rate Difference|15.2|STANDARD_ERROR_OF_MEAN|10.17|=|0.141|TWO_SIDED|95.0|-4.72|35.15|||Cochran-Mantel-Haenszel|||Week 12||35.15|-4.72|=0.1410
70895535|NCT04162769|141279298|SUPERIORITY||Response Rate Difference|8.4|STANDARD_ERROR_OF_MEAN|7.65|=|0.269|TWO_SIDED|95.0|-6.61|23.38|||Cochran-Mantel-Haenszel|||Week 12||23.38|-6.61|=0.2690
70895536|NCT04162769|141279298|SUPERIORITY||Response Rate Difference|4.3|STANDARD_ERROR_OF_MEAN|7.09|=|0.5428|TWO_SIDED|95.0|-9.56|18.25|||Cochran-Mantel-Haenszel|||Week 12||18.25|-9.56|=0.5428
70895537|NCT04162769|141279299|SUPERIORITY||Least square mean difference|-2.81|STANDARD_ERROR_OF_MEAN|7.721|=|0.7163|TWO_SIDED|95.0|-18.089|12.466|||Mixed Models Analysis|||Week 12||12.466|-18.089|=0.7163
70895538|NCT04162769|141279299|SUPERIORITY||Least square mean difference|-13.24|STANDARD_ERROR_OF_MEAN|7.602|=|0.084|TWO_SIDED|95.0|-28.284|1.805|||Mixed Models Analysis|||Week 12||1.805|-28.284|=0.0840
70895539|NCT02163733|141279309|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CIs being within 70% to 143%.|Geometric mean ratio|106.05|||||TWO_SIDED|90.0|94.82|118.6|||||Fed / Fasted ratio. Linear mixed-effects model with sequence, period, and treatment as fixed effects and subject nested within sequence as a random effect. Least squares geometric mean ratio (LSGMR) Fed = 7847, Fasted = 7399.|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being within 70-143% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 6% change in exposure was also assumed.||118.60|94.82|
70895540|NCT02163733|141279310|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CIs being within 70% to 143%|Geometric mean ratio|92.75|||||TWO_SIDED|90.0|81.4|105.68|||||Fed / Fasted ratio. Linear mixed-effects model with sequence, period, and treatment as fixed effects and subject nested within sequence as a random effect. LSGMR Fed = 208.0, Fasted = 224.3.|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being within 70-143% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 6% change in exposure was also assumed.||105.68|81.40|
70895541|NCT02163733|141279318|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|81.15|||||TWO_SIDED|90.0|57.86|113.83|||||Fed / Fasted ratio. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis. Linear mixed-effects model with treatment as fixed effect. LSGMR Fed = 497.6, Fasted = 613.2.|AZ5104||113.83|57.86|
70895542|NCT02163733|141279318|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|88.21|||||TWO_SIDED|90.0|65.21|119.32|||||Fed / Fasted ratio. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis. Linear mixed-effects model with treatment as fixed effect. LSGMR Fed = 235.0, Fasted = 266.4.|AZ7550||119.32|65.21|
70895543|NCT02163733|141279319|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|76.68|||||TWO_SIDED|90.0|55.31|106.32|||||Fed / Fasted ratio. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis. Linear mixed-effects model with treatment as fixed effect. LSGMR Fed = 9.163, Fasted = 11.95.|AZ5104||106.32|55.31|
70895544|NCT02163733|141279319|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|82.92|||||TWO_SIDED|90.0|60.99|112.74|||||Fed / Fasted ratio. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis. Linear mixed-effects model with treatment as fixed effect. LSGMR Fed = 4.236, Fasted = 5.109.|AZ7550||112.74|60.99|
70895545|NCT02633800|141279324|OTHER|Both Log-rank test and Cox regression analysis did not adjust stratification factors.|Hazard Ratio (HR)|0.9291||||0.8342|TWO_SIDED|95.0|0.4856|1.7778||Unstratified Log-rank p-value|Log Rank|||Heregulin-high population - Patritumab vs Placebo||1.7778|0.4856|0.8342
70895546|NCT00000392|141279330|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||ANOVA|||||||0.18
70895547|NCT01992380|141279349|OTHER||ICC|0.971|||||TWO_SIDED|95.0|0.935|0.988|||||Assessed the agreement between the test and retest imaging of the combination VOI SUVr|Intraclass correlation coefficient \[ICC(2,1)\] analysis from Shrout and Fleiss||0.988|0.935|
70895548|NCT01992380|141279350|OTHER||ICC|0.968|||||TWO_SIDED|95.0|0.926|0.986|||||Assessed the agreement between the test and retest imaging of the combination VOI SUVr|Intraclass correlation coefficient \[ICC(2,1)\] analysis from Shrout and Fleiss||0.986|0.926|
70895549|NCT00386880|141279351|SUPERIORITY_OR_OTHER|||||||0.59||||||Fisher's exact test.|Fisher Exact|||During the acute migraine attack, 90% of allodynic subjects and 75% of subjects without allodynia had phonophobia.||||0.59
70895550|NCT04149405|141279361|OTHER||Mean Difference (Final Values)|0.01|||<|0.01|TWO_SIDED||||||Kruskal-Wallis|||||||<0.01
70895551|NCT04149405|141279362|OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
70895552|NCT04149405|141279363|OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
70895553|NCT04149405|141279364|OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
70895554|NCT00423176|141279365|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.44||||||95.0|-1.14|0.25|||||For days 1-29|||0.25|-1.14|
70895555|NCT00423176|141279365|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.82||||||95.0|-1.65|0.0|||||For follow-up days 30-43|||0.00|-1.65|
70895556|NCT00423176|141279366|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|8.8||||||95.0|-0.5|18.2|||||Change from baseline to endpoint|||18.2|-0.5|
70895557|NCT01654549|141279367|SUPERIORITY_OR_OTHER|||||||0.94|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.94
70895558|NCT01654549|141279367|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||t-test, 2 sided|||||||0.78
70895559|NCT01654549|141279367|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Paired t-test|||||||<0.01
70895560|NCT01654549|141279367|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Paired t-test|||||||<0.01
70895561|NCT01654549|141279367|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||t-test, 2 sided|||||||0.10
70895562|NCT05072080|141279379|SUPERIORITY||Mean Difference (Final Values)|96.6|||<|0.0001|TWO_SIDED|95.0|95.0|97.5||p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups. All 3 coprimary endpoints were required to be met for success, so no multiple comparisons were performed.|Chi-squared||Seroresponse rate difference is (PXVX0317 minus placebo).|Day 22||97.5|95.0|<0.0001
70895563|NCT05072080|141279381|SUPERIORITY||GMT Ratio|206.0|||<|0.0001|TWO_SIDED|95.0|183.0|232.0||All 3 coprimary endpoints were required to be met for success, so no multiple comparisons were performed.|ANOVA|ANOVA model includes site and treatment group as fixed effects, assuming normality of log titers. p-value tests equivalence of group GMTs on log scale|Ratio of GMTs is (PXVX0317:placebo).|Day 22||232|183|<0.0001
70895564|NCT05072080|141279383|EQUIVALENCE|Success criterion was pairwise GMT ratios (104:105, 105:106, 104:106) each with a two-sided 95% CI within \[0.667; 1.5\].|GMT Ratio|0.98|||||TWO_SIDED|95.0|0.85|1.14|||||All 3 coprimary endpoints were required to be met for success, so no multiple comparisons were performed. GMT estimates and 95% CIs are derived from an ANOVA model that includes site and product lot as fixed effects assuming normality of log titers.|||1.14|0.85|
70895565|NCT05072080|141279383|EQUIVALENCE|Success criterion was pairwise GMT ratios (104:105, 105:106, 104:106) each with a two-sided 95% CI within \[0.667; 1.5\].|GMT Ratio|0.97|||||TWO_SIDED|95.0|0.84|1.12|||||All 3 coprimary endpoints were required to be met for success, so no multiple comparisons were performed. GMT estimates and 95% CIs are derived from an ANOVA model that includes site and product lot as fixed effects assuming normality of log titers.|||1.12|0.84|
70895566|NCT05072080|141279383|EQUIVALENCE|Success criterion was pairwise GMT ratios (104:105, 105:106, 104:106) each with a two-sided 95% CI within \[0.667; 1.5\].|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.82|1.1|||||All 3 coprimary endpoints were required to be met for success, so no multiple comparisons were performed. GMT estimates and 95% CIs are derived from an ANOVA model that includes site and product lot as fixed effects assuming normality of log titers.|||1.10|0.82|
70895567|NCT05072080|141279385|SUPERIORITY||Mean Difference (Final Values)|96.0|||<|0.0001|TWO_SIDED|95.0|94.3|96.8||Key secondary endpoints were tested hierarchically, such that each was only tested if all 3 coprimary endpoints and prior key secondary endpoints were met, so no multiple comparisons were performed.|Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|Day 15||96.8|94.3|<0.0001
70895568|NCT05072080|141279385|SUPERIORITY||Mean Difference (Final Values)|84.0|||<|0.0001|TWO_SIDED|95.0|81.7|85.6||Key secondary endpoints were tested hierarchically, such that each was only tested if all 3 coprimary endpoints and prior key secondary endpoints were met, so no multiple comparisons were performed.|Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|Day 183||85.6|81.7|<0.0001
70895569|NCT05072080|141279385|SUPERIORITY||Mean Difference (Final Values)|46.1|||<|0.0001|TWO_SIDED|95.0|43.8|48.1||Key secondary endpoints were tested hierarchically, such that each was only tested if all 3 coprimary endpoints and prior key secondary endpoints were met, so no multiple comparisons were performed.|Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|Day 8||48.1|43.8|<0.0001
70895570|NCT05072080|141279387|SUPERIORITY||GMT Ratio|13.0|||<|0.0001|TWO_SIDED|95.0|11.0|14.0|||ANOVA|ANOVA model includes site and treatment group as fixed effects, assuming normality of log titers. p-value tests equivalence of group GMTs on log scale|Ratio of GMTs is (PXVX0317:placebo)|Day 8||14|11|<0.0001
70895571|NCT05072080|141279387|SUPERIORITY||GMT Ratio|144.0|||<|0.0001|TWO_SIDED|95.0|128.0|162.0|||ANOVA|ANOVA model includes site and treatment group as fixed effects, assuming normality of log titers. p-value tests equivalence of group GMTs on log scale|Ratio of GMTs is (PXVX0317:placebo)|Day 15||162|128|<0.0001
70895572|NCT05072080|141279387|SUPERIORITY||GMT Ratio|41.0|||<|0.0001|TWO_SIDED|95.0|37.0|46.0|||ANOVA|ANOVA model includes site and treatment group as fixed effects, assuming normality of log titers. p-value tests equivalence of group GMTs on log scale|Ratio of GMTs is (PXVX0317:placebo)|Day 183||46|37|<0.0001
70895573|NCT05072080|141279389|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95% CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 8||||<0.0001
70895574|NCT05072080|141279389|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95% CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 15||||<0.0001
70895575|NCT05072080|141279389|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95% CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 22||||<0.0001
70895576|NCT05072080|141279389|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95% CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 183||||<0.0001
70895577|NCT05072080|141279391|SUPERIORITY||Mean Difference (Final Values)|90.7|||<|0.0001|TWO_SIDED|95.0|88.7|91.9|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 8||91.9|88.7|<0.0001
70895578|NCT05072080|141279391|SUPERIORITY||Mean Difference (Final Values)|98.7|||<|0.0001|TWO_SIDED|95.0|97.2|99.3||p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Chi-squared||Seroresponse rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 15||99.3|97.2|<0.0001
70895579|NCT05072080|141279391|SUPERIORITY||Mean Difference (Final Values)|97.6|||<|0.0001|TWO_SIDED|95.0|95.8|98.5|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 22||98.5|95.8|<0.0001
70895580|NCT05072080|141279391|SUPERIORITY||Mean Difference (Final Values)|96.8|||<|0.0001|TWO_SIDED|95.0|94.8|97.9|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 183||97.9|94.8|<0.0001
70895581|NCT05072080|141279391|SUPERIORITY||Mean Difference (Final Values)|64.8|||<|0.0001|TWO_SIDED|95.0|62.5|66.7|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 8||66.7|62.5|<0.0001
70895582|NCT05072080|141279391|SUPERIORITY||Mean Difference (Final Values)|97.8|||<|0.0001|TWO_SIDED|95.0|96.3|98.4|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 15||98.4|96.3|<0.0001
70895583|NCT05072080|141279391|SUPERIORITY||Mean Difference (Final Values)|97.2|||<|0.0001|TWO_SIDED|95.0|95.5|98.1|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 22||98.1|95.5|<0.0001
70895584|NCT05072080|141279391|SUPERIORITY||Mean Difference (Final Values)|91.4|||<|0.0001|TWO_SIDED|95.0|89.4|92.7|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 183||92.7|89.4|<0.0001
70895585|NCT05554237|141279394|OTHER||Ratio of adjusted geometric means|83.46|||||TWO_SIDED|90.0|74.67|93.29|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (for CTB 800 mg + AVP 1350 mg versus CTB 800mg only)|||93.29|74.67|
70895586|NCT05554237|141279396|OTHER||Ratio of adjusted geometric means|89.7|||||TWO_SIDED|90.0|87.24|92.23|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (for CTB 800 mg + AVP 1350 mg versus CTB 800mg only|||92.23|87.24|
70895587|NCT05554237|141279399|OTHER||Ratio of adjusted geometric means|89.91|||||TWO_SIDED|90.0|87.47|92.41|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (for CTB 800 mg + AVP 1350 mg versus CTB 800mg only|||92.41|87.47|
70895588|NCT05554237|141279419|OTHER||Ratio of adjusted geometric mean|104.47|||||TWO_SIDED|90.0|84.94|128.5|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|Cis-CTB Day 6 versus Day 7||128.50|84.94|
70895589|NCT05554237|141279419|OTHER||Ratio of adjusted geometric mean|129.54|||||TWO_SIDED|90.0|119.37|140.58|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|Cis-CTB Day 6 versus Day 7||140.58|119.37|
70895590|NCT05554237|141279419|OTHER||Ratio of adjusted geometric mean|101.46|||||TWO_SIDED|90.0|88.68|116.08|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|Cis-CTB Day 6 versus Day 7||116.08|88.68|
70895591|NCT05554237|141279419|OTHER||Ratio of adjusted geometric means|86.99|||||TWO_SIDED|90.0|74.48|101.59|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted) for CTB 400 mg + AVP 1350 mg only|Trans-CTB Day 6 versus Day 7||101.59|74.48|
70895592|NCT05554237|141279421|OTHER||Ratio of adjusted geometric mean|102.21|||||TWO_SIDED|90.0|88.67|117.8|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|Cis-CTB Day 6 versus Day 7||117.80|88.67|
70895593|NCT05554237|141279421|OTHER||Ratio of adjusted geometric mean|133.79|||||TWO_SIDED|90.0|119.84|149.36|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|Cis-CTB Day 6 versus Day 7||149.36|119.84|
70895594|NCT05554237|141279421|OTHER||Ratio of adjusted geometric mean|99.93|||||TWO_SIDED|90.0|90.7|110.1|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|Cis-CTB Day 6 versus Day 7||110.10|90.70|
70895595|NCT05554237|141279421|OTHER||Ratio of adjusted geometric mean|89.17|||||TWO_SIDED|90.0|75.27|105.63|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted) for CTB 400 mg + AVP 1350 mg only|Trans-CTB Day 6 versus Day 7||105.63|75.27|
70895596|NCT05554237|141279427|OTHER||Ratio of adjusted geometric mean|93.69|||||TWO_SIDED|90.0|78.37|112.02|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|AVI- Day 6 versus Day 7||112.02|78.37|
70895597|NCT05554237|141279427|OTHER||Ratio of adjusted geometric mean|113.07|||||TWO_SIDED|90.0|88.31|144.76|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|AVI-CTB Day 6 versus Day 7||144.76|88.31|
70895598|NCT05554237|141279427|OTHER||Ratio of adjusted geometric mean|107.06||||||90.0|92.77|123.54|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|AVI- Day 6 versus Day 7||123.54|92.77|
70895599|NCT05554237|141279427|OTHER||Ratio of adjusted geometric mean|80.68|||||TWO_SIDED|90.0|68.32|95.27|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|HPA- Day 6 versus Day 7||95.27|68.32|
70895600|NCT05554237|141279427|OTHER||Ratio of adjusted geometric mean|89.92|||||TWO_SIDED|90.0|69.7|116.02|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|HPA- Day 6 versus Day 7||116.02|69.70|
70895601|NCT05554237|141279427|OTHER||Ratio of adjusted geometric mean|97.65|||||TWO_SIDED|90.0|84.08|113.41|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|HPA- Day 6 versus Day 7||113.41|84.08|
70895602|NCT05554237|141279428|OTHER||Ratio of adjusted geometric mean|102.33|||||TWO_SIDED|90.0|90.37|115.87|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|AVI- Day 6 versus Day 7||115.87|90.37|
70895603|NCT05554237|141279428|OTHER||Ratio of adjusted geometric mean|117.83|||||TWO_SIDED|90.0|100.61|138.0|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|AVI- Day 6 versus Day 7||138.00|100.61|
70895604|NCT05554237|141279428|OTHER||Ratio of adjusted geometric mean|115.88|||||TWO_SIDED|90.0|104.12|128.98|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|AVI- Day 6 versus Day 7||128.98|104.12|
70895605|NCT05554237|141279428|OTHER||Ratio of adjusted geometric mean|85.27|||||TWO_SIDED|90.0|70.37|103.32|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|HPA- Day 6 versus Day 7||103.32|70.37|
70895606|NCT05554237|141279428|OTHER||Ratio of adjusted geometric mean|97.69|||||TWO_SIDED|90.0|78.83|121.06|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|HPA- Day 6 versus Day 7||121.06|78.83|
70895607|NCT05554237|141279428|OTHER||Ratio of adjusted geometric mean|102.85|||||TWO_SIDED|90.0|94.8|111.58|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|HPA- Day 6 versus Day 7||111.58|94.80|
70895608|NCT05554237|141279443|OTHER||Ratio of adjusted geometric mean|105.47|||||TWO_SIDED|90.0|86.64|128.39|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|AVI- Day 6 versus Day 7||128.39|86.64|
70895609|NCT05554237|141279443|OTHER||Ratio of adjusted geometric mean|134.24||||||90.0|51.81|347.81|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|AVI- Day 6 versus Day 7||347.81|51.81|
70895610|NCT05554237|141279443|OTHER||Ratio of adjusted geometric mean|91.17||||||90.0|79.54|104.51|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|HPA- Day 6 versus Day 7||104.51|79.54|
70895611|NCT05554237|141279443|OTHER||Ratio of adjusted geometric mean|115.26|||||TWO_SIDED|90.0|71.46|185.9|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|HPA- Day 6 versus Day 7||185.90|71.46|
70895612|NCT05554237|141279445|OTHER||Ratio of adjusted geometric mean|114.83|||||TWO_SIDED|90.0|101.1|130.43|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|AVI- Day 6 versus Day 7||130.43|101.10|
70895613|NCT05554237|141279445|OTHER||Ratio of adjusted geometric mean|140.44|||||TWO_SIDED|90.0|104.17|189.34|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|AVI- Day 6 versus Day 7||189.34|104.17|
70895614|NCT05554237|141279445|OTHER||Ratio of adjusted geometric mean|101.46||||||90.0|90.79|113.39|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|HPA- Day 6 versus Day 7||113.39|90.79|
70895615|NCT05554237|141279445|OTHER||Ratio of adjusted geometric means|123.2|||||TWO_SIDED|90.0|110.25|137.67|||||Model is a mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|HPA- Day 6 versus Day 7||137.67|110.25|
70895616|NCT02395042|141279462|SUPERIORITY||Least Squares Mean Difference|-1.15||||0.142|||||||ANCOVA|ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or \> 5) as factors.||||||0.142
70895617|NCT02395042|141279462|SUPERIORITY||Least Squares Mean Difference|-0.92||||0.319|||||||ANCOVA|ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or \> 5) as factors.||||||0.319
70895618|NCT02395042|141279463|SUPERIORITY||Least Squares Mean Difference|-1.46||||0.024|||||||ANCOVA|ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or \> 5) as factors.||||||0.024
70895619|NCT02395042|141279463|SUPERIORITY||Least Squares Mean Difference|-1.02||||0.137|||||||ANCOVA|ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or \> 5) as factors.||||||0.137
70895620|NCT02308748|141279485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.8||||0.025|TWO_SIDED|95.0|-25.2|-14.3||Adjustment for multiple comparisons was performed according to the Bonferroni method.|Mixed Models Analysis|||Change in QTc interval on the ECG measured in milliseconds when dofetilide is administered with mexiletine compared to when dofetilide is administered alone at evening dose on treatment day.||-14.3|-25.2|0.025
70895621|NCT02308748|141279485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.7||||0.025|TWO_SIDED|95.0|-25.2|-14.1||Adjustment for multiple comparisons was performed according to the Bonferroni method.|Mixed Models Analysis|||Change in QTc interval on the ECG measured in milliseconds when dofetilide is administered with lidocaine compared to when dofetilide is administered alone at evening dose on treatment day.||-14.1|-25.2|0.025
70895622|NCT02308748|141279485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.2||||0.025|TWO_SIDED|95.0|-28.0|-18.3||Adjustment for multiple comparisons was performed according to the Bonferroni method.|Mixed Models Analysis|||Change in J-Tpeakc interval on the ECG measured in milliseconds when dofetilide is administered with mexiletine compared to when dofetilide is administered alone at evening dose on treatment day.||-18.3|-28.0|0.025
70895623|NCT02308748|141279485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.5||||0.025|TWO_SIDED|95.0|-25.5|-15.5||Adjustment for multiple comparisons was performed according to the Bonferroni method.|Mixed Models Analysis|||Change in J-Tpeakc interval on the ECG measured in milliseconds when dofetilide is administered with lidocaine compared to when dofetilide is administered alone at evening dose on treatment day.||-15.5|-25.5|0.025
70895624|NCT02308748|141279486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9||||0.025|TWO_SIDED|95.0|-1.0|6.7||Adjustment for multiple comparisons was performed according to the Bonferroni method.|Mixed Models Analysis|||||6.7|-1|0.025
70895625|NCT02979262|141279487|SUPERIORITY||||||>|0.1|||||||Repeated Measures GLM|Time 2 at 16 weeks||||||>.10
70895626|NCT02979262|141279488|SUPERIORITY||||||<|0.01|||||||GEE|||||||<.01
70895627|NCT02979262|141279489|SUPERIORITY||||||>|0.1|||||||GEE|||||||>.10
70895628|NCT02979262|141279490|SUPERIORITY||||||>|0.1|||||||GEE|||||||>.10
70895629|NCT02979262|141279491|SUPERIORITY||||||>|0.1|||||||GEE|||||||>.10
70895630|NCT02979262|141279492|SUPERIORITY||||||<|0.01|||||||GEE|||||||<.01
70895631|NCT00866840|141279514|OTHER|||||||||||||||||No objective responses were seen in the first phase and accrual was stopped.|No objective responses were seen in the first phase and accrual was stopped.|||
70895632|NCT02625623|141279517|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.8078|TWO_SIDED|95.0|0.88|1.41|||Log Rank|The treatment arms were compared using a stratified, 1-sided, log rank Test. The stratification factor was region (Asia versus non Asia).||||1.41|0.88|0.8078
70895633|NCT02625623|141279518|SUPERIORITY||Hazard Ratio (HR)|1.73||||1|TWO_SIDED|95.0|1.36|2.21|||Log Rank|The treatment arms were compared using a stratified, 1-sided, log rank Test. The stratification factor was region (Asia versus non Asia).||||2.21|1.36|1.0000
70895634|NCT02625623|141279520|SUPERIORITY||Odds Ratio (OR)|0.709||||0.8764|||||||Cochran-Mantel-Haenszel|The treatment arms were compared by 1-sided CMH test. The stratification factor was region (Asia versus non Asia).||||||0.8764
70895635|NCT02352948|141279545|OTHER|Sub-study A was not powered and thus no formal statistical comparisons were performed.|Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.42|0.93|||||Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|For sub-study A: durvalumab monotherapy treatment arm was compared with SoC.||0.93|0.42|
70895636|NCT02352948|141279545|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.109|TWO_SIDED|95.0|0.61|1.05|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with SoC.||1.05|0.61|0.109
70895637|NCT02352948|141279546|OTHER|Sub-study A was not powered and thus no formal statistical comparisons were performed.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.49|1.04|||||Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|For sub-study A: durvalumab monotherapy treatment arm was compared with SoC.||1.04|0.49|
70895638|NCT02352948|141279546|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.056|TWO_SIDED|95.0|0.59|1.01|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with SoC.||1.01|0.59|0.056
70895639|NCT02352948|141279547|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.885|TWO_SIDED|95.0|0.74|1.3|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|As part of the contribution of components analysis for sub-study B, durvalumab plus tremelimumab treatment arm was compared with durvalumab monotherapy.||1.30|0.74|0.885
70895640|NCT02352948|141279547|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.153|TWO_SIDED|95.0|0.56|1.11|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|As part of the contribution of components analysis for sub-study B, durvalumab plus tremelimumab treatment arm was compared with tremelimumab monotherapy.||1.11|0.56|0.153
70895641|NCT02352948|141279548|SUPERIORITY|||||||0.063||||||The z-test statistic is the ratio of log-transformed ratio of the cumulative hazards in the 2 treatment arms divided by square root of the variance.|z-test|The variance is estimated using the delta method and Greenwood's formula.||For sub-study B: durvalumab plus tremelimumab treatment arm was compared with SoC.||||0.063
70895642|NCT02352948|141279549|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.282|TWO_SIDED|95.0|0.68|1.12|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|As part of the contribution of components analysis for sub-study B, durvalumab plus tremelimumab treatment arm was compared with durvalumab monotherapy.||1.12|0.68|0.282
70895643|NCT02352948|141279549|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.011|TWO_SIDED|95.0|0.49|0.92|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|As part of the contribution of components analysis for sub-study B, durvalumab plus tremelimumab treatment arm was compared with tremelimumab monotherapy.||0.92|0.49|0.011
70895644|NCT02352948|141279550|OTHER|Sub-study A was not powered and thus no formal statistical comparisons were performed.|Odds Ratio (OR)|3.87|||||TWO_SIDED|95.0|1.61|10.1|||||The analysis was performed using logistic regression adjusting for SoC therapy (gemcitabine/vinorelbine versus erlotinib) and histology (squamous versus all other histology types), with 95% CI calculated by profile likelihood.|For sub-study A: durvalumab monotherapy treatment arm was compared with SoC.||10.10|1.61|
70895645|NCT02352948|141279550|SUPERIORITY||Odds Ratio (OR)|2.43||||0.037|TWO_SIDED|95.0|1.1|5.94|||Regression, Logistic||The analysis was performed using logistic regression adjusting for SoC therapy (gemcitabine/vinorelbine versus erlotinib) and histology (squamous versus all other histology types), with 95% CI calculated by profile likelihood.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with SoC.||5.94|1.10|0.037
70895646|NCT02352948|141279550|SUPERIORITY||Odds Ratio (OR)|0.97||||0.923|TWO_SIDED|95.0|0.51|1.89|||Regression, Logistic||The analysis was performed using logistic regression adjusting for SoC therapy (gemcitabine/vinorelbine versus erlotinib) and histology (squamous versus all other histology types), with 95% CI calculated by profile likelihood.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with durvalumab monotherapy.||1.89|0.51|0.923
70895647|NCT02352948|141279550|SUPERIORITY||Odds Ratio (OR)|2.46||||0.109|TWO_SIDED|95.0|0.91|8.61|||Regression, Logistic||The analysis was performed using logistic regression adjusting for SoC therapy (gemcitabine/vinorelbine versus erlotinib) and histology (squamous versus all other histology types), with 95% CI calculated by profile likelihood.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with tremelimumab monotherapy.||8.61|0.91|0.109
70895648|NCT02352948|141279554|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.002|TWO_SIDED|95.0|0.49|0.85|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with SoC.||0.85|0.49|0.002
70895649|NCT00240487|141279584|NON_INFERIORITY_OR_EQUIVALENCE|The primary outcome variable is the mean PaO2/FiO2 in each group after 8 hours of study participation to determine whether timing of treatment with nitric oxide impacts outcome (immediate treatment versus delayed treatment).|||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||Differences in mean PaO2/FiO2 ratios between the two groups will help to determine whether order of therapy (immediate treatment with nitric oxide versus delayed treatment with nitric oxide) impacts outcomes.||||>0.05
70895650|NCT01258608|141279586|OTHER||Hazard Ratio (HR)|1.192||||0.7382|ONE_SIDED|90.0||1.737||P-value for comparison of treatment groups obtained from stratified log-rank test-stratified by Barcelona Clinic Liver Cancer and Eastern Cooperative Oncology Group (ECOG) performance status.|Stratified log-rank test||Hazard ratio comparing mapatumumab to placebo obtained from Cox proportional hazards model with covariate adjustment for Barcelona Clinic Liver Cancer and ECOG performance status.|||1.737||0.7382
70895651|NCT01258608|141279587|OTHER||Hazard Ratio (HR)|0.922||||0.3156|ONE_SIDED|90.0||1.288||P-value for comparison of treatment groups obtained from stratified log-rank test-stratified by Barcelona Clinic Liver Cancer and Eastern Cooperative Oncology Group (ECOG) performance status.|Stratified log-rank test||Hazard ratio comparing mapatumumab to placebo obtained from Cox proportional hazards model with covariate adjustment for Barcelona Clinic Liver Cancer and ECOG performance status.|||1.288||0.3156
70895652|NCT01258608|141279588|OTHER||Hazard Ratio (HR)|1.007||||0.6121|ONE_SIDED|90.0||1.346||P-value for comparison of treatment groups obtained from stratified log-rank test-stratified by Barcelona Clinic Liver Cancer and ECOG performance status.|Stratified log-rank test||Hazard ratio comparing mapatumumab to placebo obtained from Cox proportional hazards model with covariate adjustment for Barcelona Clinic Liver Cancer and ECOG performance status.|||1.346||0.6121
70895653|NCT01258608|141279589|OTHER||Hazard Ratio (HR)|1.066||||0.6925|ONE_SIDED|90.0||1.43||P-value for comparison of treatment groups obtained from stratified log-rank test - stratified by Barcelona Clinic Liver Cancer and ECOG performance status.|Stratified log-rank test||Hazard ratio comparing Mapatumumab to placebo obtained from Cox proportional hazards model with covariate adjustment for Barcelona Clinic Liver Cancer and ECOG performance status.|||1.430||0.6925
70895654|NCT01258608|141279590|OTHER||Hazard Ratio (HR)|0.909||||0.3088|ONE_SIDED|90.0||1.191||P-value for comparison of treatment groups obtained from stratified log-rank test - stratified by Barcelona Clinic Liver Cancer and ECOG performance status.|Stratified log-rank test||Hazard ratio comparing Mapatumumab to placebo obtained from Cox proportional hazards model with covariate adjustment for Barcelona Clinic Liver Cancer and ECOG performance status.|||1.191||0.3088
70895655|NCT01258608|141279591|OTHER||Response rate difference|5.4||||0.5458|TWO_SIDED|95.0|-16.8|26.6||Nominal P-value for comparison of treatment groups obtained from Fisher's exact test.|Fisher Exact|||||26.6|-16.8|0.5458
70895656|NCT01258608|141279592|OTHER||Response rate difference|6.7||||0.3479|TWO_SIDED|95.0|-13.4|26.2||Nominal P-value for comparison of treatment groups obtained from Fisher's exact test.|Fisher Exact|||||26.2|-13.4|0.3479
70895657|NCT01258608|141279593|OTHER||Disease control rate difference|-20.7||||0.0198|TWO_SIDED|95.0|-40.8|1.8||Nominal P-value for comparison of treatment groups obtained from Fisher's exact test.|Fisher Exact|||||1.8|-40.8|0.0198
70895658|NCT01258608|141279594|OTHER||Disease control rate difference|-5.8||||0.6558|TWO_SIDED|95.0|-25.4|13.8||Nominal P-value for comparison of treatment groups obtained from Fisher's exact test.|Fisher Exact|||||13.8|-25.4|0.6558
70895659|NCT04098939|141279608|EQUIVALENCE|Bland-Altman plots|Bland-Altman plots|0.39|||<|0.05|TWO_SIDED|95.0|0.26|1.04||Analysis of Bland-Altman plots|Bland-Altman plots|Analysis of Bland-Altman plots|||Analysis of Bland-Altman plots|1.04|0.26|<0.05
70895660|NCT02943408|141279609|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|||||||.90
70895661|NCT02943408|141279610|SUPERIORITY|||||||0.99|||||||Mixed Models Analysis|||||||.99
70895662|NCT02943408|141279611|SUPERIORITY|||||||0.56|||||||Mixed Models Analysis|||||||.56
70895663|NCT02943408|141279612|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||||||.85
70895664|NCT02943408|141279613|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||||||.43
70895665|NCT02943408|141279614|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||||||.82
70895666|NCT02943408|141279615|SUPERIORITY|||||||0.5|||||||Mixed Models Analysis|||||||.50
70895667|NCT02943408|141279616|SUPERIORITY|||||||0.56|||||||Mixed Models Analysis|||||||.56
70895668|NCT02943408|141279617|SUPERIORITY|||||||0.92|||||||Mixed Models Analysis|||||||.92
70895669|NCT02943408|141279618|SUPERIORITY|||||||0.65|||||||Mixed Models Analysis|||||||.65
70895670|NCT02943408|141279619|SUPERIORITY|||||||0.35|||||||Mixed Models Analysis|||||||.35
70895671|NCT01106833|141279621|SUPERIORITY|||||||0.63||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportion of participants with treatment success at 6 months is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.63
70895672|NCT01106833|141279621|SUPERIORITY|||||||0.44||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportion of participants with treatment success at 24 months is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.44
70895673|NCT01106833|141279622|SUPERIORITY|||||||0.205||||||Two-sided testing was performed using a significance level of 0.05|Log Rank|||The null hypothesis is that the rate of overall survival during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.205
70895674|NCT01106833|141279623|SUPERIORITY|||||||0.141||||||Two-sided testing was performed using a significance level of 0.05|Log Rank|||The null hypothesis is that the rate of progression-free survival during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.141
70895675|NCT01106833|141279624|SUPERIORITY|||||||0.775||||||Two-sided testing was performed using a significance level of 0.05|Log Rank|||The null hypothesis is that the rate of failure-free survival during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.775
70895676|NCT01106833|141279625|SUPERIORITY|||||||0.396||||||Two-sided testing was performed using a significance level of 0.05|Gray's test|Death without relapse was treated as a competing risk||The null hypothesis is that the rate of relapse during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.396
70895677|NCT01106833|141279626|SUPERIORITY|||||||0.219||||||Two-sided testing was performed using a significance level of 0.05|Gray's test|Death without initiation of secondary therapy is considered a competing risk for this endpoint||The null hypothesis is that the rate of initiation of secondary immunosuppressive therapy for chronic GVHD during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.219
70895678|NCT01106833|141279627|SUPERIORITY|||||||0.706||||||Two-sided testing was performed using a significance level of 0.05|Gray's test|Death without discontinuation of systemic immunosuppressive therapy is considered a competing risk for this endpoint||The null hypothesis is that the rate of discontinuation of systemic immunosuppressive therapy during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.706
70895679|NCT01106833|141279628|SUPERIORITY|||||||0.127||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median prednisone dose at baseline is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.127
70895680|NCT01106833|141279628|SUPERIORITY|||||||0.562||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median prednisone dose at 6 months post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.562
70895681|NCT01106833|141279628|SUPERIORITY|||||||0.129||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median prednisone dose at 1 year post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.129
70895682|NCT01106833|141279629|SUPERIORITY|||||||0.586||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median change in prednisone dose from baseline to 6 months post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.586
70895683|NCT01106833|141279629|SUPERIORITY|||||||0.14||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median change in prednisone dose from baseline to 1 year post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.140
70895684|NCT01106833|141279630|SUPERIORITY|||||||0.582||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median serum creatinine level at baseline is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.582
70895685|NCT01106833|141279630|SUPERIORITY|||||||0.208||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median serum creatinine level at 6 months post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.208
70895686|NCT01106833|141279630|SUPERIORITY|||||||0.431||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median serum creatinine level at 1 year post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.431
70895687|NCT01106833|141279631|SUPERIORITY|||||||0.147||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median change in serum creatinine level from baseline to 6 months post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.147
70895688|NCT01106833|141279631|SUPERIORITY|||||||0.863||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median change in serum creatinine level from baseline to 1 year post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.863
70895689|NCT01106833|141279632|SUPERIORITY|||||||0.62||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the patient-reported severity and vital status categories considered at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.620
70895690|NCT01106833|141279632|SUPERIORITY|||||||0.258||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the patient-reported severity and vital status categories considered at 6 months post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.258
70895691|NCT01106833|141279632|SUPERIORITY|||||||0.036||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the patient-reported severity and vital status categories considered at 1 year post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.036
70895692|NCT01106833|141279632|SUPERIORITY|||||||0.369||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the patient-reported severity and vital status categories considered at 2 years post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.369
70895693|NCT01106833|141279633|SUPERIORITY|||||||0.45||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the provider-reported severity and vital status categories considered at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.450
70895694|NCT01106833|141279633|SUPERIORITY|||||||0.301||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the provider-reported severity and vital status categories considered at 6 months post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.301
70895695|NCT01106833|141279633|SUPERIORITY|||||||0.75||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the provider-reported severity and vital status categories considered at 1 year post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.750
70895696|NCT01106833|141279633|SUPERIORITY|||||||0.444||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the provider-reported severity and vital status categories considered at 2 years post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.444
70895697|NCT01106833|141279634|SUPERIORITY|||||||0.238||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the NIH Consensus Criteria severity and vital status categories considered at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.238
70895698|NCT01106833|141279634|SUPERIORITY|||||||0.546||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the NIH Consensus Criteria severity and vital status categories considered at 6 months post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.546
70895699|NCT01106833|141279634|SUPERIORITY|||||||0.756||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the NIH Consensus Criteria severity and vital status categories considered at 1 year post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.756
70895700|NCT01106833|141279634|SUPERIORITY|||||||0.554||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the NIH Consensus Criteria severity and vital status categories considered at 2 years post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.554
70895701|NCT01106833|141279635|SUPERIORITY|||||||0.685||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean PCS scores at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.685
70895702|NCT01106833|141279635|SUPERIORITY|||||||0.105||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean PCS scores at 2 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.105
70895703|NCT01106833|141279635|SUPERIORITY|||||||0.039||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean PCS scores at 6 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.039
70895704|NCT01106833|141279635|SUPERIORITY|||||||0.278||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean PCS scores at 1 year are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.278
70895705|NCT01106833|141279635|SUPERIORITY|||||||0.804||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean PCS scores at 2 years are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.804
70895706|NCT01106833|141279636|SUPERIORITY|||||||0.631||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean MCS scores at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.631
70895707|NCT01106833|141279636|SUPERIORITY|||||||0.759||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean MCS scores at 2 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.759
70895708|NCT01106833|141279636|SUPERIORITY|||||||0.391||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean MCS scores at 6 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.391
70895709|NCT01106833|141279636|SUPERIORITY|||||||0.222||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean MCS scores at 1 year are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.222
70895710|NCT01106833|141279636|SUPERIORITY|||||||0.527||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean MCS scores at 2 years are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.527
70895711|NCT01106833|141279637|SUPERIORITY|||||||0.763||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean FACT-BMT scores at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.763
70895712|NCT01106833|141279637|SUPERIORITY|||||||0.133||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean FACT-BMT scores at 2 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.133
70895713|NCT01106833|141279637|SUPERIORITY|||||||0.953||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean FACT-BMT scores at 6 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.953
70895714|NCT01106833|141279637|SUPERIORITY|||||||0.398||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean FACT-BMT scores at 1 year are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.398
70895715|NCT01106833|141279637|SUPERIORITY|||||||0.309||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean FACT-BMT scores at 2 years are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.309
70895716|NCT00886340|141279639|SUPERIORITY_OR_OTHER|||||||0.08||95.0||||controlled for site, income, race/ethnicity|Mixed Models Analysis|||pilot test, used 20% of sample required for a full test of the hypothesis||||0.08
70895717|NCT02120027|141279693|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.986||||0.949|TWO_SIDED|95.0|0.64|1.53|||Cochran-Mantel-Haenszel|||||1.53|0.64|0.949
70895718|NCT02120027|141279694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.193|TWO_SIDED|95.0|0.88|1.86|||Cochran-Mantel-Haenszel|||||1.86|0.88|0.193
70895719|NCT02120027|141279695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.032||||0.872|TWO_SIDED|95.0|0.7|1.53|||Cochran-Mantel-Haenszel|||||1.53|0.70|0.872
70895720|NCT02120027|141279696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.339||||0.272|TWO_SIDED|95.0|0.79|2.26|||Cochran-Mantel-Haenszel|||||2.26|0.79|0.272
70895721|NCT02120027|141279697|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.153||||0.567|TWO_SIDED|95.0|0.73|1.81|||Cochran-Mantel-Haenszel|||||1.81|0.73|0.567
70895722|NCT01002872|141279698|SUPERIORITY|||||||0.037|||||||t-test, 2 sided|||||||0.037
70895723|NCT01002872|141279699|SUPERIORITY|||||||0.721|||||||t-test, 2 sided|||||||0.721
70895724|NCT01002872|141279700|SUPERIORITY|||||||0.897|||||||t-test, 2 sided|||||||0.897
70895725|NCT01002872|141279701|SUPERIORITY|||||||0.743|||||||t-test, 2 sided|||||||0.743
70895726|NCT01002872|141279702|SUPERIORITY|||||||0.416|||||||t-test, 2 sided|||||||0.416
70895727|NCT01002872|141279703|SUPERIORITY|||||||0.672|||||||t-test, 2 sided|||||||0.672
70895728|NCT01002872|141279704|SUPERIORITY|||||||0.955|||||||t-test, 2 sided|||||||0.955
70895729|NCT01002872|141279705|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70895730|NCT01002872|141279706|SUPERIORITY|||||||0.0066|||||||t-test, 2 sided|||||||0.0066
70895731|NCT00414817|141279707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.018||||0.002|TWO_SIDED|95.0|0.006|0.03|||Regression, Linear|2-tailed p-value based on linear regression adjusted for site, age, sex, co-morbid COPD, baseline use of short acting beta agonists, and baseline mMPR|Estimated adherence was approximately 2 percentage points higher for intervention group than for usual care group.|In all of our analyses we used duration of follow-up as a weighting variable to reflect the fact that our adherence measure becomes more accurate and reliable with longer follow-up. This weighting is reflected both in the formal statistical analyses and in the presentation of means and standard deviations given above. Also, sensitivity analyses that included daily oral steroid users and those with fewer than 3 months of follow-up yielded similar results to those presented here.||.030|.006|.002
70895732|NCT00414817|141279708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.175|TWO_SIDED|95.0|-0.23|0.04|||Regression, Linear|2-tailed p-value adjusted for site, age, sex, co-morbid COPD, baseline use of short acting beta agonists, and baseline adherence.||In all of our analyses we used duration of follow-up as a weighting variable. This weighting is reflected both in the formal statistical analyses and in the presentation of means and standard deviations given above.||0.04|-0.23|0.175
70895733|NCT00414817|141279709|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.852|TWO_SIDED|95.0|0.96|1.06||2-tailed p-value based on overdispersed Poisson regression adjusted for site, age, sex, co-morbid COPD, baseline use of short acting beta agonists, and baseline mMPR|overdispersed Poisson regression|||In all of our analyses we used duration of follow-up as a weighting variable. This weighting is reflected both in the formal statistical analyses and in the presentation of means and standard deviations given above.||1.06|0.96|0.852
70895734|NCT02314624|141279811|SUPERIORITY|||||||0.734||||||Analyses were performed on each subscale individually. This is the p-value for the Depression subscale.|Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.734
70895735|NCT02314624|141279811|SUPERIORITY|||||||0.27||||||Analyses were performed on each subscale individually. This is the p-value for the Anxiety subscale.|Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline||We used a Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.27
70895736|NCT02314624|141279811|SUPERIORITY|||||||0.75||||||Analyses were performed on each subscale individually. This is the p-value for the Stress subscale.|Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline||We used a Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.75
70895737|NCT02314624|141279811|SUPERIORITY|||||||0.812||||||Analyses were performed on each subscale individually. This is the p-value for the Suicide subscale.|Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.812
70895738|NCT02314624|141279812|SUPERIORITY|||||||0.036|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.036
70895739|NCT02314624|141279813|SUPERIORITY|||||||0.664|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.664
70895740|NCT02314624|141279814|SUPERIORITY|||||||0.764|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.764
70895741|NCT02314624|141279815|SUPERIORITY|||||||0.44|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.440
70895742|NCT02314624|141279816|SUPERIORITY|||||||0.09|||||||Chi-squared|GEE Type III chi squared distribution with 2 degrees of freedom was used to examine between-condition change over time.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.09
70895743|NCT02314624|141279817|SUPERIORITY|||||||0.19|||||||Chi-squared|GEE Type III chi squared distribution with 2 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.19
70895744|NCT02314624|141279818|SUPERIORITY|||||||0.15|||||||Chi-squared|GEE Type III chi squared distribution with 1 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.15
70895745|NCT02314624|141279819|SUPERIORITY||||||<|0.001|||||||Chi-squared|GEE Type III chi squared distribution with 1 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||<.001
70895746|NCT02314624|141279820|SUPERIORITY|||||||0.14|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.14
70895747|NCT02314624|141279821|SUPERIORITY|||||||0.22|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.22
70895748|NCT02314624|141279822|SUPERIORITY||||||<|0.001|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||<.001
70895749|NCT02314624|141279823|SUPERIORITY|||||||0.001|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.001
70895750|NCT02314624|141279824|SUPERIORITY|||||||0.99|||||||Chi-squared|GEE Type III chi squared distribution with 2 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.99
70895751|NCT03148470|141279853|OTHER|||||||0.932||||||This p-value refers to the effect of stimulation (cTBS vs iTBS).|Mixed Models Analysis|||||||0.932
70895752|NCT03148470|141279854|OTHER|||||||0.642|||||||Mixed Models Analysis|||||||0.642
70895753|NCT00713648|141279863|SUPERIORITY_OR_OTHER||Mean (Lambda)|0.048||||||95.0|0.0094|0.2501|||Poisson model (log-link)|The estimated rate was adjusted for age and overdispersion which was estimated by Pearson's chi-square statistic divided by its degrees of freedom.|Mean (Lambda) refer to the estimate of the annualised bleeding rate|||0.2501|0.0094|
70895754|NCT00464815|141279893|NON_INFERIORITY|Criterion for non-inferiority: the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Nimenrix Group minus Mencevax ACWY Group) in the percentage of subjects with bactericidal vaccine response was greater than or equal to (≥) the pre-defined clinical limit of -10%.|Rate difference|7.87|||||TWO_SIDED|95.0|1.63|14.87||||||To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax ACWY vaccine in term of rSBA-MenA vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for the meningococcal serogroup A (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.||14.87|1.63|
70895755|NCT00464815|141279893|NON_INFERIORITY|Criterion for non-inferiority: the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval for the group difference \[Nimenrix Group minus Mencevax ACWY Group\] in the percentage of subjects with bactericidal vaccine response was greater than or equal to (≥) the pre-defined clinical limit of -10%.|Rate Difference|0.67|||||TWO_SIDED|95.0|-1.65|4.18||||||To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax ACWY vaccine in term of rSBA-MenC vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for the meningococcal serogroup C (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.||4.18|-1.65|
70895756|NCT00464815|141279893|NON_INFERIORITY|Criterion for non-inferiority: the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval for the group difference \[Nimenrix Group minus Mencevax ACWY Group\] in the percentage of subjects with bactericidal vaccine response was greater than or equal to (≥) the pre-defined clinical limit of -10%.|Rate difference|8.9|||||TWO_SIDED|95.0|4.78|14.14||||||To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax ACWY vaccine in term of rSBA-MenW-135 vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for the meningococcal serogroup W-135 (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.||14.14|4.78|
70895757|NCT00464815|141279893|NON_INFERIORITY|Criterion for non-inferiority: the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference \[Nimenrix Group minus Mencevax ACWY Group\] in the percentage of subjects with bactericidal vaccine response was greater than or equal to (≥) the pre-defined clinical limit of -10%.|Rate difference|15.22|||||TWO_SIDED|95.0|9.89|21.37||||||To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax ACWY vaccine in term of rSBA-MenY vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for the meningococcal serogroup Y (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.||21.37|9.89|
70895758|NCT00464815|141279894|NON_INFERIORITY|Criterion for non-inferiority: the upper limit (UL) of the 2-sided standardized asymptotic 95% CI for the ratio of the percentages of subjects with any Grade 3 general symptom was lower than or equal to (≤) the pre-defined clinical limit of 3.0.|Risk Ratio (RR)|4.02||||0.1456|TWO_SIDED|95.0|0.68|24.6|||Chi-squared|||To demonstrate the non-inferiority of Nimenrix™ vaccine versus Mencevax™ vaccine in terms of incidence of any Grade 3 general (solicited and unsolicited) symptom, the 2-sided standardised asymptotic 95% CI for the ratio between Nimenrix and Mencevax groups (Nimenrix over Mencevax) in the percentage of subjects with any grade 3 general symptom within 4 days after vaccination was computed for the safety analysis in study MenACWY-TT-036.||24.6|0.68|0.1456
70895759|NCT04386096|141279912|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
70895760|NCT04386096|141279914|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||Change in Adolescent Pre-Intention Factors||||0.30
70895761|NCT04386096|141279914|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||Change in Parent Pre-Intention Factors||||0.71
70895762|NCT04386096|141279915|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||Change in Adolescent Intention to take/give ADHD medicine regularly||||0.29
70895763|NCT04386096|141279915|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||Change in Parent Intention to take/give ADHD medicine regularly||||0.19
70895764|NCT04386096|141279916|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||||||0.64
70895765|NCT04386096|141279917|SUPERIORITY|||||||0.81|||||||t-test, 2 sided|||||||0.81
70895766|NCT04386096|141279919|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||Change in Adolescent: Child Seek||||0.10
70895767|NCT04386096|141279919|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||Change in Adolescent: Child Express||||0.51
70895768|NCT04386096|141279919|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||Change in Adolescent: Parent Seek||||0.84
70895769|NCT04386096|141279919|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||Change in Adolescent: Parent Express||||0.93
70895770|NCT04386096|141279919|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||Change in Adolescent: Joint/Options||||0.43
70895771|NCT04386096|141279919|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||Change in Parent: Child Seek||||0.94
70895772|NCT04386096|141279919|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||Change in Parent: Child Express||||0.79
70895773|NCT04386096|141279919|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||Change in Parent: Parent Seek||||0.61
70895774|NCT04386096|141279919|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||Change in Parent: Parent Express||||0.10
70895775|NCT04386096|141279919|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|||Change in Parent: Joint/Options||||0.98
70895776|NCT04402866|141279929|OTHER||Common Odds Ratio|1.142||||0.6137|TWO_SIDED|95.0|0.706|1.846|||Van Elteren test||Common Odds Ratio (TD-0903 vs. placebo) and corresponding 95% Wald confidence interval (CI) were obtained from the proportional odds regression model of RFD adjusting for baseline age strata (≤ 60 years vs. \> 60 years).|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.||1.846|0.706|0.6137
70895777|NCT04402866|141279930|OTHER|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.|LS mean difference|-0.51||||0.962|TWO_SIDED|95.0|-21.95|20.92|||Mixed model repeated measures model|||Part 2: TD-0903 - Parallel-Group 3 mg versus Part 2: Matching Placebo - Parallel-Group||20.92|-21.95|0.962
70895778|NCT04402866|141279931|OTHER|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.|Odds Ratio (OR)|1.153||||0.5918|TWO_SIDED|95.0|0.692|1.922|||Van Elteren test||Between-group comparisons analyzed using a proportional odds model adjusting for baseline age strata (≤ 60 years vs. \> 60 years).|Part 2: TD-0903 - Parallel-Group 3 mg versus Part 2: Matching Placebo - Parallel-Group on Day 7||1.922|0.692|0.5918
70895779|NCT04402866|141279931|OTHER|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.|Odds Ratio (OR)|1.105||||0.6978|TWO_SIDED|95.0|0.651|1.878|||Van Elteren test|||Part 2: TD-0903 - Parallel-Group 3 mg versus Part 2: Matching Placebo - Parallel-Group on Day 14|Between-group comparisons analyzed using a proportional odds model adjusting for baseline age strata (≤ 60 years vs. \> 60 years).|1.878|0.651|0.6978
70895780|NCT04402866|141279931|OTHER|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.|Odds Ratio (OR)|1.295||||0.399|TWO_SIDED|95.0|0.702|2.388|||Van Elteren test|||Part 2: TD-0903 - Parallel-Group 3 mg versus Part 2: Matching Placebo - Parallel-Group on Day 21|Between-group comparisons analyzed using a proportional odds model adjusting for baseline age strata (≤ 60 years vs. \> 60 years).|2.388|0.702|0.3990
70895781|NCT04402866|141279931|OTHER|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.|Odds Ratio (OR)|1.18||||0.6445|TWO_SIDED|95.0|0.605|2.299|||Van Elteren test||Between-group comparisons analyzed using a proportional odds model adjusting for baseline age strata (≤ 60 years vs. \> 60 years).|Part 2: TD-0903 - Parallel-Group 3 mg versus Part 2: Matching Placebo - Parallel-Group on Day 28||2.299|0.605|0.6445
70895782|NCT04402866|141279932|OTHER|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.|Risk Difference (RD)|5.06||||0.3005|TWO_SIDED|95.0|-4.5|14.63||The p-value was calculated using the Cochran-Mantel-Haenszel chi-square test stratified by baseline age group (≤ 60 years vs. \> 60 years)|Cochran-Mantel-Haenszel chi-square test|||Part 2: TD-0903 - Parallel-Group 3 mg versus Part 2: Matching Placebo - Parallel-Group||14.63|-4.50|0.3005
70895783|NCT01814371|141279933|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.757|||||||Fisher Exact|||||||0.757
70895784|NCT01814371|141279934|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||1|||||||Fisher Exact|||||||1.00
70895785|NCT01814371|141279935|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.687|||||||Fisher Exact|||||||0.687
70895786|NCT01814371|141279936|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||1|||||||Fisher Exact|||||||1.00
70895787|NCT01814371|141279937|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.811|||||||Fisher Exact|||||||0.811
70895788|NCT01814371|141279938|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.004|||||||Fisher Exact|||||||0.004
70895789|NCT01814371|141279939|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.006|||||||Fisher Exact|||||||0.006
70895790|NCT01814371|141279940|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.05|||||||Fisher Exact|||||||0.050
70895791|NCT01814371|141279941|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.007|||||||Fisher Exact|||||||0.007
70895792|NCT01814371|141279942|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.005|||||||Fisher Exact|||||||0.005
70895793|NCT01814371|141279943|EQUIVALENCE|testing equivalence of individualized approach compared to household approach.||||||1|||||||Fisher Exact|||||||1.00
70895794|NCT01814371|141279944|EQUIVALENCE|testing equivalence of before and after decolonization protocol.||||||0.84|||||||Chi-squared|||||||0.84
70895795|NCT01814371|141279946|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.381|||||||Fisher Exact|||||||0.381
70895796|NCT01814371|141279947|EQUIVALENCE|testing equivalence of individualized approach compared to household approach.||||||0.143|||||||Fisher Exact|||||||0.143
70895797|NCT01972841|141279996|SUPERIORITY||Least squares mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.12||0.072|TWO_SIDED|95.0|-0.49|-0.01||Nominal p-value|Stratified rank ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.01|-0.49|0.072
70895798|NCT01972841|141279996|SUPERIORITY||Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.033|TWO_SIDED|95.0|-0.44|0.04||Nominal p-value|Stratified rank ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.04|-0.44|0.033
70895799|NCT01972841|141279996|SUPERIORITY||Least squares mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.12||0.001|TWO_SIDED|95.0|-0.58|-0.1|||Stratified rank ANCOVA||Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.10|-0.58|0.001
70895800|NCT01972841|141279996|SUPERIORITY||Least squares mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.12||0.052|TWO_SIDED|95.0|-0.47|0.01|||Stratified rank ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.01|-0.47|0.052
70895801|NCT01972841|141279997|SUPERIORITY||Least squares mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.14||0.04|TWO_SIDED|95.0|-0.57|-0.01||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.01|-0.57|0.040
70895802|NCT01972841|141279997|SUPERIORITY||Least squares mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.14||0.006|TWO_SIDED|95.0|-0.67|-0.11||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.11|-0.67|0.006
70895803|NCT01972841|141279997|SUPERIORITY||Least squares mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14||0.001|TWO_SIDED|95.0|-0.76|-0.21||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.21|-0.76|0.001
70895804|NCT01972841|141279997|SUPERIORITY||Least squares mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.84|-0.28||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.28|-0.84|<0.001
70895805|NCT01972841|141279998|SUPERIORITY||Least squares mean difference|3.85|STANDARD_ERROR_OF_MEAN|3.13||0.219|TWO_SIDED|95.0|-2.29|10.0||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||10.00|-2.29|0.219
70895806|NCT01972841|141279998|SUPERIORITY||Least squares mean difference|8.75|STANDARD_ERROR_OF_MEAN|3.13||0.005|TWO_SIDED|95.0|2.61|14.89||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||14.89|2.61|0.005
70895807|NCT01972841|141279998|SUPERIORITY||Least squares mean difference|21.52|STANDARD_ERROR_OF_MEAN|3.14|<|0.001|TWO_SIDED|95.0|15.35|27.68||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||27.68|15.35|<0.001
70895808|NCT01972841|141279998|SUPERIORITY||Least squares mean difference|17.74|STANDARD_ERROR_OF_MEAN|3.14|<|0.001|TWO_SIDED|95.0|11.58|23.9||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||23.90|11.58|<0.001
70895809|NCT01972841|141279999|SUPERIORITY||Least squares mean difference|-4.63|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-6.98|-2.27|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-2.27|-6.98|<0.001
70895810|NCT01972841|141279999|SUPERIORITY||Least squares mean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.21|<|0.001|TWO_SIDED|95.0|-8.17|-3.44|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-3.44|-8.17|<0.001
70895811|NCT01972841|141279999|SUPERIORITY||Least squares mean difference|-7.13|STANDARD_ERROR_OF_MEAN|1.21|<|0.001|TWO_SIDED|95.0|-9.5|-4.76|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-4.76|-9.50|<0.001
70895812|NCT01972841|141279999|SUPERIORITY||Least squares mean difference|-6.1|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-8.46|-3.74|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-3.74|-8.46|<0.001
70895813|NCT01972841|141280000|SUPERIORITY||Least squares mean difference|0.25|STANDARD_ERROR_OF_MEAN|0.14||0.077|TWO_SIDED|95.0|-0.03|0.52|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.52|-0.03|0.077
70895814|NCT01972841|141280000|SUPERIORITY||Least squares mean difference|0.27|STANDARD_ERROR_OF_MEAN|0.14||0.05|TWO_SIDED|95.0|0.0|0.55|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.55|0.00|0.050
70895815|NCT01972841|141280000|SUPERIORITY||Least squares mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.14||0.008|TWO_SIDED|95.0|0.1|0.65|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.65|0.10|0.008
70895816|NCT01972841|141280000|SUPERIORITY||Least squares mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.14||0.007|TWO_SIDED|95.0|0.1|0.65|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.65|0.10|0.007
70895817|NCT01972841|141280001|SUPERIORITY||Rate ratio|0.87|STANDARD_ERROR_OF_MEAN|0.09||0.135|TWO_SIDED|95.0|0.72|1.04|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.||1.04|0.72|0.135
70895818|NCT01972841|141280001|SUPERIORITY||Rate ratio|0.9|STANDARD_ERROR_OF_MEAN|0.09||0.282|TWO_SIDED|95.0|0.75|1.09|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.||1.09|0.75|0.282
70895819|NCT01972841|141280001|SUPERIORITY||Rate ratio|0.71|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|0.59|0.85|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.||0.85|0.59|<0.001
70895820|NCT01972841|141280001|SUPERIORITY||Rate ratio|0.88|STANDARD_ERROR_OF_MEAN|0.1||0.172|TWO_SIDED|95.0|0.73|1.06|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.||1.06|0.73|0.172
70895821|NCT01972841|141280002|SUPERIORITY||least squares mean difference|-1.64|STANDARD_ERROR_OF_MEAN|0.83||0.074|TWO_SIDED|95.0|-3.27|-0.01|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.offset variable.||-0.01|-3.27|0.074
70895822|NCT01972841|141280002|SUPERIORITY||Least squares mean difference|-1.33|STANDARD_ERROR_OF_MEAN|0.83||0.025|TWO_SIDED|95.0|-2.96|0.3|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.30|-2.96|0.025
70895823|NCT01972841|141280002|SUPERIORITY||least square mean difference|-2.36|STANDARD_ERROR_OF_MEAN|0.83|<|0.001|TWO_SIDED|95.0|-4.0|-0.73|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.73|-4.00|<0.001
70895824|NCT01972841|141280002|SUPERIORITY||Least squares mean difference|-1.59|STANDARD_ERROR_OF_MEAN|0.84||0.024|TWO_SIDED|95.0|-3.23|0.05|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.05|-3.23|0.024
70895825|NCT01972841|141280006|SUPERIORITY||Least squares mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.29||0.52|TWO_SIDED|95.0|-0.39|0.76|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.||0.76|-0.39|0.520
70895826|NCT01972841|141280006|SUPERIORITY||Least squares mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.29||0.413|TWO_SIDED|95.0|-0.82|0.34|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.||0.34|-0.82|0.413
70895827|NCT01972841|141280006|SUPERIORITY||Least squares mean difference|-0.92|STANDARD_ERROR_OF_MEAN|0.29||0.002|TWO_SIDED|95.0|-1.5|-0.34|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.||-0.34|-1.50|0.002
70895828|NCT01972841|141280006|SUPERIORITY||Least squares mean diffrence|-0.56|STANDARD_ERROR_OF_MEAN|0.3||0.06|TWO_SIDED|95.0|-1.13|0.02|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.||0.02|-1.13|0.060
70895829|NCT01972841|141280007|SUPERIORITY||Rate ratio|0.85|STANDARD_ERROR_OF_MEAN|0.1||0.11|TWO_SIDED|95.0|0.7|1.04|||Negative binomial regression|||Rate ratio of number of urgency incontinence episodes during the 7-day diary bet. the given combination group \& the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65,≥ 65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of urgency incontinence episodes used divided by number of valid diary days) included as a covariate \& postbaseline number of valid diary days as offset variable.||1.04|0.70|0.110
70895830|NCT01972841|141280007|SUPERIORITY||Rate ratio|0.9|STANDARD_ERROR_OF_MEAN|0.1||0.288|TWO_SIDED|95.0|0.73|1.1|||Negative binomial regression|||Rate ratio of number of urgency incontinence episodes during the 7-day diary bet. the given combination group \& the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65,≥ 65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of urgency incontinence episodes used divided by number of valid diary days) included as a covariate \& postbaseline number of valid diary days as offset variable.||1.10|0.73|0.288
70895831|NCT01972841|141280007|SUPERIORITY||Rate ratio|0.65|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|0.53|0.79|||Negative binomial regression|||Rate ratio of number of urgency incontinence episodes during the 7-day diary bet. the given combination group \& the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65,≥ 65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of urgency incontinence episodes used divided by number of valid diary days) included as a covariate \& postbaseline number of valid diary days as offset variable.||0.79|0.53|<0.001
70895832|NCT01972841|141280007|SUPERIORITY||Rate ratio|0.84|STANDARD_ERROR_OF_MEAN|0.1||0.084|TWO_SIDED|95.0|0.68|1.02|||Negative binomial regression|||Rate ratio of number of urgency incontinence episodes during the 7-day diary bet. the given combination group \& the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65,≥ 65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of urgency incontinence episodes used divided by number of valid diary days) included as a covariate \& postbaseline number of valid diary days as offset variable.||1.02|0.68|0.084
70895833|NCT01972841|141280008|SUPERIORITY||Least squares mean difference|-1.61|STANDARD_ERROR_OF_MEAN|0.76||0.114|TWO_SIDED|95.0|-3.09|-0.13|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.13|-3.09|0.114
70895834|NCT01972841|141280008|SUPERIORITY||Least squares mean difference|-1.62|STANDARD_ERROR_OF_MEAN|0.76||0.034|TWO_SIDED|95.0|-3.1|-0.13|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.13|-3.10|0.034
70895835|NCT01972841|141280008|SUPERIORITY||Least squares mean difference|-2.61|STANDARD_ERROR_OF_MEAN|0.76|<|0.001|TWO_SIDED|95.0|-4.09|-1.12|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-1.12|-4.09|<0.001
70895836|NCT01972841|141280008|SUPERIORITY||Least squares mean difference|-2.21|STANDARD_ERROR_OF_MEAN|0.76||0.012|TWO_SIDED|95.0|-3.7|-0.71|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.71|-3.70|0.012
70895837|NCT01972841|141280009|SUPERIORITY||Least squares mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.11||0.134|TWO_SIDED|95.0|-0.46|-0.02|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.02|-0.46|0.134
70895838|NCT01972841|141280009|SUPERIORITY||Least squares mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.11||0.043|TWO_SIDED|95.0|-0.45|-0.02|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.02|-0.45|0.043
70895839|NCT01972841|141280009|SUPERIORITY||Least squares mean diffeence|-0.37|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.59|-0.15|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.15|-0.59|<0.001
70895840|NCT01972841|141280009|SUPERIORITY||Standard Error of the Mean|-0.32|STANDARD_ERROR_OF_MEAN|0.11||0.019|TWO_SIDED|5.0|-0.54|-0.1|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50mg ) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.10|-0.54|0.019
70895841|NCT01972841|141280010|SUPERIORITY||Least squares mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.18||0.074|TWO_SIDED|95.0|-0.69|0.03|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.03|-0.69|0.074
70895842|NCT01972841|141280010|SUPERIORITY||Least squares mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.014|TWO_SIDED|95.0|-0.82|-0.09|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.09|-0.82|0.014
70895843|NCT01972841|141280010|SUPERIORITY||Least squares mean difference|-0.65|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.01|-0.28|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.28|-1.01|<0.001
70895844|NCT01972841|141280010|SUPERIORITY||Least squares mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.24|0.51|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.51|-1.24|<0.001
70895845|NCT01972841|141280011|SUPERIORITY||Rate ratio|0.88|STANDARD_ERROR_OF_MEAN|0.05||0.006|TWO_SIDED|95.0|0.81|0.96|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||0.96|0.81|0.006
70895846|NCT01972841|141280011|SUPERIORITY||Rate ratio|0.81|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|0.74|0.88|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||0.88|0.74|<0.001
70895847|NCT01972841|141280011|SUPERIORITY||Rate ratio|0.91|STANDARD_ERROR_OF_MEAN|0.05||0.049|TWO_SIDED|95.0|0.84|1.0|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||1.00|0.84|0.049
70895848|NCT01972841|141280011|SUPERIORITY||Rate ratio|0.86|STANDARD_ERROR_OF_MEAN|0.05||0.001|TWO_SIDED|95.0|0.79|0.94|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||0.94|0.79|0.001
70895849|NCT01972841|141280012|SUPERIORITY||Least squares mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.34||0.073|TWO_SIDED|95.0|-1.28|0.06|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.06|-1.28|0.073
70895850|NCT01972841|141280012|SUPERIORITY||Least squares mean difference|-1.16|STANDARD_ERROR_OF_MEAN|0.34||0.001|TWO_SIDED|95.0|-1.83|-0.48|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.48|-1.83|0.001
70895851|NCT01972841|141280012|SUPERIORITY||Least squares mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.34||0.14|TWO_SIDED|95.0|-1.18|0.17|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.17|-1.18|0.140
70895852|NCT01972841|141280012|SUPERIORITY||Least squares mean difference|-1.21|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-1.88|-0.54|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.54|-1.88|<0.001
70895853|NCT01972841|141280013|SUPERIORITY||Least squares mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.065|TWO_SIDED|95.0|-0.19|0.01|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.01|-0.19|0.065
70895854|NCT01972841|141280013|SUPERIORITY||Least squares mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.05||0.001|TWO_SIDED|95.0|-0.26|-0.07|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.07|-0.26|0.001
70895855|NCT01972841|141280013|SUPERIORITY||Least squares mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.1|TWO_SIDED|95.0|-0.18|0.02|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.02|-0.18|0.100
70895856|NCT01972841|141280013|SUPERIORITY||Least squares mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.05||0.001|TWO_SIDED|95.0|-0.26|-0.07|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.07|-0.26|0.001
70895857|NCT01972841|141280014|SUPERIORITY||Rate ratio|1.01|STANDARD_ERROR_OF_MEAN|0.12||0.938|TWO_SIDED|95.0|0.8|1.27|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||1.27|0.80|0.938
70895858|NCT01972841|141280014|SUPERIORITY||Rate ratio|1.0|STANDARD_ERROR_OF_MEAN|0.12||0.967|TWO_SIDED|95.0|0.79|1.25|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||1.25|0.79|0.967
70895859|NCT01972841|141280014|SUPERIORITY||Standard Error of the Mean|0.73|STANDARD_ERROR_OF_MEAN|0.12||0.008|TWO_SIDED|95.0|0.58|0.92|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||0.92|0.58|0.008
70895860|NCT01972841|141280014|SUPERIORITY||Rate ratio|0.8|STANDARD_ERROR_OF_MEAN|0.12||0.069|TWO_SIDED|95.0|0.64|1.02|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||1.02|0.64|0.069
70895861|NCT01972841|141280015|SUPERIORITY||Least squares mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.86||0.958|TWO_SIDED|95.0|-1.73|1.64|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||1.64|-1.73|0.958
70895862|NCT01972841|141280015|SUPERIORITY||Least squares mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.86||0.5|TWO_SIDED|95.0|-2.27|1.11|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||1.11|-2.27|0.500
70895863|NCT01972841|141280015|SUPERIORITY||Least squares mean difference|-1.91|STANDARD_ERROR_OF_MEAN|0.87||0.028|TWO_SIDED|95.0|-3.62|-0.2|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.20|-3.62|0.028
70895864|NCT01972841|141280015|SUPERIORITY||Least squares mean difference|-1.41|STANDARD_ERROR_OF_MEAN|0.88||0.108|TWO_SIDED|95.0|-3.13|0.31|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.31|-3.13|0.108
70895865|NCT01972841|141280016|SUPERIORITY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.13||0.993|TWO_SIDED|95.0|-0.25|0.25|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.25|-0.25|0.993
70895866|NCT01972841|141280016|SUPERIORITY||Least squares mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.13||0.65|TWO_SIDED|95.0|-0.3|0.19|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.19|-0.30|0.650
70895867|NCT01972841|141280016|SUPERIORITY||Least squares mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.13||0.035|TWO_SIDED|95.0|-0.52|-0.02|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.02|-0.52|0.035
70895868|NCT01972841|141280016|SUPERIORITY||Least squares mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.13||0.169|TWO_SIDED|95.0|-0.43|0.08|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate||0.08|-0.43|0.169
70895869|NCT01972841|141280017|SUPERIORITY||Odds Ratio (OR)|1.37||||0.003|TWO_SIDED|95.0|1.11|1.68|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.||1.68|1.11|0.003
70895870|NCT01972841|141280017|SUPERIORITY||Odds Ratio (OR)|1.36||||0.004|TWO_SIDED|95.0|1.11|1.68|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.||1.68|1.11|0.004
70895871|NCT01972841|141280017|SUPERIORITY||Odds Ratio (OR)|1.59|||<|0.001|TWO_SIDED|95.0|1.29|1.95|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.||1.95|1.29|<0.001
70895872|NCT01972841|141280017|SUPERIORITY||Odds Ratio (OR)|1.36||||0.004|TWO_SIDED|95.0|1.1|1.68|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.||1.68|1.10|0.004
70895873|NCT01972841|141280018|SUPERIORITY||Odds Ratio (OR)|1.23||||0.039|TWO_SIDED|95.0|1.01|1.5|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.50|1.01|0.039
70895874|NCT01972841|141280018|SUPERIORITY||Odds Ratio (OR)|1.3||||0.009|TWO_SIDED|95.0|1.07|1.59|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.59|1.07|0.009
70895875|NCT01972841|141280018|SUPERIORITY||Odds Ratio (OR)|1.45|||<|0.001|TWO_SIDED|95.0|1.19|1.77|||overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.77|1.19|<0.001
70895876|NCT01972841|141280018|SUPERIORITY||Odds Ratio (OR)|1.5|||<|0.001|TWO_SIDED|95.0|1.23|1.84|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate||1.84|1.23|<0.001
70895877|NCT01972841|141280019|SUPERIORITY||Odds Ratio (OR)|1.32||||0.011|TWO_SIDED|95.0|1.07|1.64|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.64|1.07|0.011
70895878|NCT01972841|141280019|SUPERIORITY||Odds Ratio (OR)|1.41||||0.002|TWO_SIDED|95.0|1.14|1.75|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.75|1.14|0.002
70895879|NCT01972841|141280019|SUPERIORITY||Odds Ratio (OR)|1.65|||<|0.001|TWO_SIDED|95.0|1.32|2.06|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||2.06|1.32|<0.001
70895880|NCT01972841|141280019|SUPERIORITY||Odds Ratio (OR)|1.66|||<|0.001|TWO_SIDED|95.0|1.33|2.07|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||2.07|1.33|<0.001
70895881|NCT01972841|141280020|SUPERIORITY||Least squares mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.41|-0.11|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.11|-0.41|<0.001
70895882|NCT01972841|141280020|SUPERIORITY||Least squares mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.54|-0.25|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.25|-0.54|<0.001
70895883|NCT01972841|141280020|SUPERIORITY||Least squares mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.20|-0.50|<0.001
70895884|NCT01972841|141280020|SUPERIORITY||Least squares mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.20|-0.50|<0.001
70895885|NCT01972841|141280022|SUPERIORITY||Least squares mean difference|3.81|STANDARD_ERROR_OF_MEAN|1.08|<|0.001|TWO_SIDED|95.0|1.69|5.94|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||5.94|1.69|<0.001
70895886|NCT01972841|141280022|SUPERIORITY||Least squares mean difference|4.16|STANDARD_ERROR_OF_MEAN|1.09|<|0.001|TWO_SIDED|95.0|2.03|6.29|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.29|2.03|<0.001
70895887|NCT01972841|141280022|SUPERIORITY||Least squares mean difference|5.02|STANDARD_ERROR_OF_MEAN|1.09|<|0.001|TWO_SIDED|95.0|2.88|7.15|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||7.15|2.88|<0.001
70895888|NCT01972841|141280022|SUPERIORITY||Least squares mean difference|3.3|STANDARD_ERROR_OF_MEAN|1.09||0.002|TWO_SIDED|95.0|1.17|5.43|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||5.43|1.17|0.002
70895889|NCT01972841|141280023|SUPERIORITY||Least squares mean difference|4.12|STANDARD_ERROR_OF_MEAN|1.29||0.001|TWO_SIDED|95.0|1.6|6.65|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.65|1.60|0.001
70895890|NCT01972841|141280023|SUPERIORITY||Lest squares mean difference|4.87|STANDARD_ERROR_OF_MEAN|1.29|<|0.001|TWO_SIDED|95.0|2.34|7.4|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||7.40|2.34|<0.001
70895891|NCT01972841|141280023|SUPERIORITY||Least squares mean difference|6.09|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|3.55|8.63|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||8.63|3.55|<0.001
70895892|NCT01972841|141280023|SUPERIORITY||Least squares mean difference|3.8|STANDARD_ERROR_OF_MEAN|1.29||0.003|TWO_SIDED|95.0|1.27|6.33|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.33|1.27|0.003
70895893|NCT01972841|141280024|SUPERIORITY||Least squares mean difference|4.24|STANDARD_ERROR_OF_MEAN|1.22||0.001|TWO_SIDED|95.0|1.84|6.63|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.63|1.84|0.001
70895894|NCT01972841|141280024|SUPERIORITY||Least squares mean difference|4.82|STANDARD_ERROR_OF_MEAN|1.22|<|0.001|TWO_SIDED|95.0|2.42|7.22|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||7.22|2.42|<0.001
70895895|NCT01972841|141280024|SUPERIORITY||Least squares mean difference|5.34|STANDARD_ERROR_OF_MEAN|1.23|<|0.001|TWO_SIDED|95.0|2.93|7.75|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||7.75|2.93|<0.001
70895896|NCT01972841|141280024|SUPERIORITY||Least squares mean difference|4.41|STANDARD_ERROR_OF_MEAN|1.22|<|0.001|TWO_SIDED|95.0|2.01|6.81|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.81|2.01|<0.001
70895897|NCT01972841|141280025|SUPERIORITY||Least squares mean difference|4.42|STANDARD_ERROR_OF_MEAN|1.24|<|0.001|TWO_SIDED|95.0|1.98|6.85|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.85|1.98|<0.001
70895898|NCT01972841|141280025|SUPERIORITY||Least squares mean difference|4.42|STANDARD_ERROR_OF_MEAN|1.24|<|0.001|TWO_SIDED|95.0|1.98|6.86|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.86|1.98|<0.001
70895899|NCT01972841|141280025|SUPERIORITY||Least squares mean difference|4.87|STANDARD_ERROR_OF_MEAN|1.25|<|0.001|TWO_SIDED|95.0|2.42|7.32|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||7.32|2.42|<0.001
70895900|NCT01972841|141280025|SUPERIORITY||Least squares mean difference|3.28|STANDARD_ERROR_OF_MEAN|1.24||0.008|TWO_SIDED|95.0|0.84|5.72|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||5.72|0.84|0.008
70895901|NCT01972841|141280026|SUPERIORITY||Least squares mean difference|2.27|STANDARD_ERROR_OF_MEAN|0.99||0.022|TWO_SIDED|95.0|0.33|4.21|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||4.21|0.33|0.022
70895902|NCT01972841|141280026|SUPERIORITY||Least squares mean difference|2.25|STANDARD_ERROR_OF_MEAN|0.99||0.023|TWO_SIDED|95.0|0.31|4.19|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||4.19|0.31|0.023
70895903|NCT01972841|141280026|SUPERIORITY||Least squares mean difference|2.8|STANDARD_ERROR_OF_MEAN|0.99||0.005|TWO_SIDED|95.0|0.85|4.74|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||4.74|0.85|0.005
70895904|NCT01972841|141280026|SUPERIORITY||Least squares mean difference|0.95|STANDARD_ERROR_OF_MEAN|0.99||0.337|TWO_SIDED|95.0|-0.99|2.89|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||2.89|-0.99|0.337
70895905|NCT01972841|141280039|SUPERIORITY||Odds Ratio (OR)|1.31||||0.035|TWO_SIDED|95.0|1.02|1.69|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.69|1.02|0.035
70895906|NCT01972841|141280039|SUPERIORITY||Odds Ratio (OR)|1.4||||0.009|TWO_SIDED|95.0|1.09|1.81|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.81|1.09|0.009
70895907|NCT01972841|141280039|SUPERIORITY||Odds Ratio (OR)|1.5||||0.002|TWO_SIDED|95.0|1.16|1.93|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.93|1.16|0.002
70895908|NCT01972841|141280039|SUPERIORITY||Odds Ratio (OR)|1.34||||0.023|TWO_SIDED|95.0|1.04|1.73|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.73|1.04|0.023
70895909|NCT01972841|141280040|SUPERIORITY||Odds Ratio (OR)|1.22||||0.224|TWO_SIDED|95.0|0.88|1.69|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||1.69|0.88|0.224
70895910|NCT01972841|141280040|SUPERIORITY||Odds Ratio (OR)|1.42||||0.037|TWO_SIDED|95.0|1.02|1.96|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||1.96|1.02|0.037
70895911|NCT01972841|141280040|SUPERIORITY||Odds Ratio (OR)|1.98|||<|0.001|TWO_SIDED|95.0|1.47|2.67|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||2.67|1.47|<0.001
70895912|NCT01972841|141280040|SUPERIORITY||Odds Ratio (OR)|1.65||||0.002|TWO_SIDED|95.0|1.21|2.26|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||2.26|1.21|0.002
70895913|NCT01972841|141280041|SUPERIORITY||Odds Ratio (OR)|1.29||||0.077|TWO_SIDED|95.0|0.97|1.72|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||1.72|0.97|0.077
70895914|NCT01972841|141280041|SUPERIORITY||Odds Ratio (OR)|1.15||||0.321|TWO_SIDED|95.0|0.87|1.53|||Logistic regression|||Odds ratio from a logistic regression model treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||1.53|0.87|0.321
70895915|NCT01972841|141280041|SUPERIORITY||Odds Ratio (OR)|1.92|||<|0.001|TWO_SIDED|95.0|1.46|2.53|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||2.53|1.46|<0.001
70895916|NCT01972841|141280041|SUPERIORITY||Odds Ratio (OR)|1.16||||0.294|TWO_SIDED|95.0|0.88|1.53|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||1.53|0.88|0.294
70895917|NCT01972841|141280042|SUPERIORITY||Odds Ratio (OR)|1.17||||0.251|TWO_SIDED|95.0|0.89|1.53|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.53|0.89|0.251
70895918|NCT01972841|141280042|SUPERIORITY||Odds Ratio (OR)|1.25||||0.107|TWO_SIDED|95.0|0.95|1.64|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.64|0.95|0.107
70895919|NCT01972841|141280042|SUPERIORITY||Odds Ratio (OR)|1.59|||<|0.001|TWO_SIDED|95.0|1.23|2.07|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||2.07|1.23|<0.001
70895920|NCT01972841|141280042|SUPERIORITY||Odds Ratio (OR)|1.41||||0.012|TWO_SIDED|95.0|1.08|1.85|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.85|1.08|0.012
70895921|NCT01972841|141280043|SUPERIORITY||Odds Ratio (OR)|1.3||||0.044|TWO_SIDED|95.0|1.01|1.67|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.67|1.01|0.044
70895922|NCT01972841|141280043|SUPERIORITY||Odds Ratio (OR)|1.43||||0.006|TWO_SIDED|95.0|1.11|1.84|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.84|1.11|0.006
70895923|NCT01972841|141280043|SUPERIORITY||Odds Ratio (OR)|1.47||||0.004|TWO_SIDED|95.0|1.13|1.9|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.90|1.13|0.004
70895924|NCT01972841|141280043|SUPERIORITY||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.23|2.08|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||2.08|1.23|<0.001
70895925|NCT01972841|141280044|SUPERIORITY||Odds Ratio (OR)|1.47||||0.004|TWO_SIDED|95.0|1.13|1.92|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||1.92|1.13|0.004
70895926|NCT01972841|141280044|SUPERIORITY||Odds Ratio (OR)|1.62|||<|0.001|TWO_SIDED|95.0|1.24|2.11|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||2.11|1.24|<0.001
70895927|NCT01972841|141280044|SUPERIORITY||Odds Ratio (OR)|1.59||||0.001|TWO_SIDED|95.0|1.22|2.07|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||2.07|1.22|0.001
70895928|NCT01972841|141280044|SUPERIORITY||Odds Ratio (OR)|1.57||||0.001|TWO_SIDED|95.0|1.21|2.04|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||2.04|1.21|0.001
70895929|NCT01972841|141280045|SUPERIORITY||Odds Ratio (OR)|1.32||||0.065|TWO_SIDED|95.0|0.98|1.78|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||1.78|0.98|0.065
70895930|NCT01972841|141280045|SUPERIORITY||Odds Ratio (OR)|1.68||||0.001|TWO_SIDED|95.0|1.24|2.27|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||2.27|1.24|0.001
70895931|NCT01972841|141280045|SUPERIORITY||Odds Ratio (OR)|1.76|||<|0.001|TWO_SIDED|95.0|1.32|2.36|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||2.36|1.32|<0.001
70895932|NCT01972841|141280045|SUPERIORITY||Odds Ratio (OR)|1.51||||0.007|TWO_SIDED|95.0|1.12|2.04|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||2.04|1.12|0.007
70895933|NCT01972841|141280046|SUPERIORITY||Odds Ratio (OR)|1.44||||0.007|TWO_SIDED|95.0|1.11|1.87|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||1.87|1.11|0.007
70895934|NCT01972841|141280046|SUPERIORITY||Odds Ratio (OR)|1.67|||<|0.001|TWO_SIDED|95.0|1.28|2.17|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||2.17|1.28|<0.001
70895935|NCT01972841|141280046|SUPERIORITY||Odds Ratio (OR)|1.76|||<|0.001|TWO_SIDED|95.0|1.34|2.3|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||2.30|1.34|<0.001
70895936|NCT01972841|141280046|SUPERIORITY||Odds Ratio (OR)|1.68|||<|0.001|TWO_SIDED|95.0|1.29|2.19|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||2.19|1.29|<0.001
70895937|NCT01972841|141280047|SUPERIORITY||Odds Ratio (OR)|1.12||||0.381|TWO_SIDED|95.0|0.87|1.45|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.||1.45|0.87|0.381
70895938|NCT01972841|141280047|SUPERIORITY||Odds Ratio (OR)|1.31||||0.04|TWO_SIDED|95.0|1.01|1.7|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.||1.70|1.01|0.040
70895939|NCT01972841|141280047|SUPERIORITY||Odds Ratio (OR)|1.56||||0.001|TWO_SIDED|95.0|1.21|2.0|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.||2.00|1.21|0.001
70895940|NCT01972841|141280047|SUPERIORITY||Odds Ratio (OR)|1.57||||0.001|TWO_SIDED|95.0|1.21|2.03|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.||2.03|1.21|0.001
70895941|NCT01972841|141280048|SUPERIORITY||Odds Ratio (OR)|1.24||||0.095|TWO_SIDED|95.0|0.96|1.59|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.||1.59|0.96|0.095
70895942|NCT01972841|141280048|SUPERIORITY||Odds Ratio (OR)|1.26||||0.073|TWO_SIDED|95.0|0.98|1.62|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.||1.62|0.98|0.073
70895943|NCT01972841|141280048|SUPERIORITY||Odds Ratio (OR)|1.66|||<|0.001|TWO_SIDED|95.0|1.29|2.13|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.||2.13|1.29|<0.001
70895944|NCT01972841|141280048|SUPERIORITY||Odds Ratio (OR)|1.27||||0.067|TWO_SIDED|95.0|0.98|1.63|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.||1.63|0.98|0.067
70895945|NCT01972841|141280049|SUPERIORITY||Odds Ratio (OR)|1.18||||0.21|TWO_SIDED|95.0|0.91|1.52|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.||1.52|0.91|0.210
70895946|NCT01972841|141280049|SUPERIORITY||Odds Ratio (OR)|1.46||||0.004|TWO_SIDED|95.0|1.13|1.89|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.||1.89|1.13|0.004
70895947|NCT01972841|141280049|SUPERIORITY||Odds Ratio (OR)|1.59|||<|0.001|TWO_SIDED|95.0|1.23|2.06|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.||2.06|1.23|<0.001
70895948|NCT01972841|141280049|SUPERIORITY||Odds Ratio (OR)|1.59|||<|0.001|TWO_SIDED|95.0|1.23|2.05|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.||2.05|1.23|<0.001
70895949|NCT01972841|141280050|SUPERIORITY||Odds Ratio (OR)|1.13||||0.335|TWO_SIDED|95.0|0.88|1.46|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.||1.46|0.88|0.335
70895950|NCT01972841|141280050|SUPERIORITY||Odds Ratio (OR)|1.4||||0.009|TWO_SIDED|95.0|1.09|1.81|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.||1.81|1.09|0.009
70895951|NCT01972841|141280050|SUPERIORITY||Odds Ratio (OR)|1.56||||0.001|TWO_SIDED|95.0|1.21|2.02|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.||2.02|1.21|0.001
70895952|NCT01972841|141280050|SUPERIORITY||Odds Ratio (OR)|1.71|||<|0.001|TWO_SIDED|95.0|1.33|2.21|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.||2.21|1.33|<0.001
70895953|NCT01972841|141280051|SUPERIORITY||Odds Ratio (OR)|1.11||||0.416|TWO_SIDED|95.0|0.86|1.43|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.||1.43|0.86|0.416
70895954|NCT01972841|141280051|SUPERIORITY||Odds Ratio (OR)|1.23||||0.105|TWO_SIDED|95.0|0.96|1.59|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.||1.59|0.96|0.105
70895955|NCT01972841|141280051|SUPERIORITY||Odds Ratio (OR)|1.66|||<|0.001|TWO_SIDED|95.0|1.28|2.16|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.||2.16|1.28|<0.001
70895956|NCT01972841|141280051|SUPERIORITY||Odds Ratio (OR)|1.45||||0.005|TWO_SIDED|95.0|1.12|1.87|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.||1.87|1.12|0.005
70895957|NCT03712891|141280066|OTHER|t-test||||||0.12|||||||t-test, 2 sided|||||||0.12
70895958|NCT02046980|141280139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.39||||0.02839|TWO_SIDED|95.0|1.58|7.31|||Regression, Logistic|||||7.31|1.58|0.02839
70895959|NCT02046980|141280139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.67||||0.0366|TWO_SIDED|95.0|1.25|5.67|||Regression, Logistic|||||5.67|1.25|0.0366
70895960|NCT01483924|141280150|SUPERIORITY_OR_OTHER|||||||0.9048|TWO_SIDED||||||ANOVA|||The difference in change in PASI score from baseline to Week 12 was compared all active treatment groups and the placebo group||||0.9048
70895961|NCT01483924|141280151|SUPERIORITY_OR_OTHER|||||||0.1975|TWO_SIDED||||||Cochran-Armitage trend test|||||||0.1975
70895962|NCT01483924|141280152|SUPERIORITY_OR_OTHER|||||||0.6349|TWO_SIDED||||||Kruskal-Wallis|||||||0.6349
70895963|NCT01483924|141280153|SUPERIORITY_OR_OTHER|||||||0.6212|TWO_SIDED||||||Kruskal-Wallis|||||||0.6212
70895964|NCT01994954|141280171|SUPERIORITY||||||<|0.03||||||A two-sided P-value of 0.05 or less was interpreted as a statistically significant result.|t-test, 2 sided|||The trial was designed to have 97% power at a type I error rate of 5% to detect a 25% intervention effect with respect to the primary outcome. this was done using an independent sample t-test. P-value was calculated, and a p-value of 0.05 or less was interpreted as statistically significant result.||||<0.03
70895965|NCT01994954|141280172|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Power calculations were based on the primary analysis (t-test comparing changes). A sample size of 130 would have given 80% power, with 0.05 two sided type 1 error rate, to detect a 20% absolute difference in emotional role limitation on the PedsQL v2.0, which we considered to be statistically significant.||||0.38
70895966|NCT00449176|141280177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.001||95.0|-1.22|-0.47|||ANCOVA|||The primary null hypothesis to be tested for the study was that the tapentadol ER group was not different from the placebo group for the primary endpoint. Assuming the mean treatment group difference of 0.7 with an SD of 2.7, 314 subjects per treatment group were estimated to provide 90% power to show that the tapentadol ER group was statistically different from placebo at an alpha level of 0.05. The total number of subjects to be randomly assigned to a treatment group for the study was 942.||-0.47|-1.22|<0.001
70895967|NCT02363946|141280258|OTHER||alpha estimate|9.557|STANDARD_ERROR_OF_MEAN|0.037|||TWO_SIDED||||||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter Cmax for Analyte AD00370||||
70895968|NCT02363946|141280258|OTHER||beta estimate|1.173|STANDARD_ERROR_OF_MEAN|0.027|||TWO_SIDED|95.0|1.128|1.218|||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter Cmax for Analyte AD00370|R-square (r\^2)=0.98|1.218|1.128|
70895969|NCT02363946|141280258|OTHER||alpha estimate|9.824|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED||||||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter Cmax for Analyte ARC-MLP||||
70895970|NCT02363946|141280258|OTHER||beta estimate|1.103|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|1.054|1.153|||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter Cmax for Analyte ARC-MLP|R-square (r\^2)=0.98|1.153|1.054|
70895971|NCT02363946|141280260|OTHER||alpha estimate|11.274|STANDARD_ERROR_OF_MEAN|0.057|||TWO_SIDED||||||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUC0-24 for Analyte AD00370||||
70895972|NCT02363946|141280260|OTHER||beta estimate|1.181|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|1.112|1.249|||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUC0-24 for Analyte AD00370|R-square (r\^2)=0.96|1.249|1.112|
70895973|NCT02363946|141280260|OTHER||alpha estimate|12.133|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED||||||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUC0-24 for Analyte ARC-MLP||||
70895974|NCT02363946|141280260|OTHER||beta estimate|1.147|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|1.08|1.215|||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUC0-24 for Analyte ARC-MLP|R-square (r\^2)=0.96|1.215|1.080|
70895975|NCT02363946|141280261|OTHER||alpha estimate|11.286|STANDARD_ERROR_OF_MEAN|0.058|||TWO_SIDED||||||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUCinf for Analyte AD00370||||
70895976|NCT02363946|141280261|OTHER||beta estimate|1.179|STANDARD_ERROR_OF_MEAN|0.041|||TWO_SIDED|95.0|1.11|1.249|||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUCinf for Analyte AD00370|R-square (r\^2)=0.96|1.249|1.110|
70895977|NCT02363946|141280261|OTHER||alpha estimate|12.347|STANDARD_ERROR_OF_MEAN|0.049|||TWO_SIDED||||||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUCinf for Analyte ARC-MLP||||
70895978|NCT02363946|141280261|OTHER||beta estimate|1.163|STANDARD_ERROR_OF_MEAN|0.049|||TWO_SIDED|95.0|1.081|1.245|||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUCinf for Analyte ARC-MLP|R-square (r\^2)=0.95|1.245|1.081|
70895979|NCT01988779|141280273|NON_INFERIORITY|Assuming that the non-inferiority limit of topical therapy is 20% of that for oral therapy.||||||0.505|||||||ANOVA|||||||0.505
70895980|NCT01988779|141280275|NON_INFERIORITY|Assuming that the non-inferiority limit of topical therapy is 20% of that for oral therapy.||||||0.39|||||||ANOVA|||||||0.390
70895981|NCT01988779|141280276|NON_INFERIORITY|Assuming that the non-inferiority limit of topical therapy is 20% of that for oral therapy.||||||0.036|||||||ANOVA|||||||0.036
70895982|NCT04493216|141280309|OTHER||Differences in percentage of participant|-9.2|||||TWO_SIDED|95.0|-24.0|5.7|||||Differences in percentage of participant = Percentage of participant in GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF - Percentage of participant in DTG+ABC/3TC or FTC/TAF|||5.7|-24.0|
70895983|NCT04493216|141280309|OTHER||Differences in percentage of participant|-1.0|||||TWO_SIDED|95.0|-13.5|11.6|||||Differences in percentage of participant = Percentage of participant in GSK3640254 150 mg+ ABC/3TC or FTC/TAF - Percentage of participant in DTG+ ABC/3TC or FTC/TAF|||11.6|-13.5|
70895984|NCT04493216|141280309|OTHER||Differences in percentage of participant|-15.5|||||TWO_SIDED|95.0|-31.2|0.3|||||Differences in percentage of participant = Percentage of participant in GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF - Percentage of participant in DTG+ ABC/3TC or FTC/TAF|||0.3|-31.2|
70895985|NCT03595579|141280328|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
70895986|NCT03595579|141280329|SUPERIORITY|||||||0.013|||||||Mixed Models Analysis|||||||0.013
70895987|NCT02606903|141280330|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means (%)|110.19|STANDARD_DEVIATION|33.603|||TWO_SIDED|90.0|96.8|125.44|||ANOVA||Relative bioavailability was estimated by the ratio (AI/PFS) of the adjusted geometric means (gMean). Standard deviation is actually inter-individual geometric coefficient of variation (%).|Analysis of variance (ANOVA) model on the log scale was used including treatment and body mass index (BMI) group as fixed effects||125.44|96.80|
70895988|NCT02606903|141280331|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means (%)|100.14|STANDARD_DEVIATION|42.354|||TWO_SIDED|90.0|85.15|117.76|||ANOVA||Relative bioavailability was estimated by the ratio (AI/PFS) of the adjusted geometric means (gMean). Standard deviation is actually inter-individual geometric coefficient of variation (%).|Analysis of variance (ANOVA) model on the log scale was used including treatment and BMI group as fixed effects||117.76|85.15|
70895989|NCT02606903|141280332|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means (%)|100.22|STANDARD_DEVIATION|53.137|||TWO_SIDED|90.0|82.13|122.29|||ANOVA||Relative bioavailability was estimated by the ratio (AI/PFS) of the adjusted geometric means (gMean). Standard deviation is actually inter-individual geometric coefficient of variation (%).|Analysis of variance (ANOVA) model on the log scale was used including treatment and BMI group as fixed effects||122.29|82.13|
70895990|NCT00483184|141280347|SUPERIORITY_OR_OTHER|||||||0.404||95.0|||||ANOVA|||Results were expressed as mean or number. Normal distributed data among the treatment groups were compared by One-way ANOVA test, non-normal distributed data were compared by Kruskal Wallis test, and then Bonferroni post-hoc test was used for multiple comparisons. Differences from baseline within treatment groups were evaluated by repeated measures ANOVA test for normal distributed data, Freidman test for non-normal distributed data.||||0.404
70895991|NCT00558428|141280349|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.64|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001||95.0|-4.9|-2.38|||ANCOVA|Adjusted for baseline and country effect||||-2.38|-4.90|<0.0001
70895992|NCT00558428|141280349|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.92|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001||95.0|-6.18|-3.66|||ANCOVA|Adjusted for baseline and country effect||||-3.66|-6.18|<0.0001
70895993|NCT00558428|141280349|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.64||||95.0|-2.66|-0.14|||ANCOVA|Adjusted for baseline and country effect||||-0.14|-2.66|
70895994|NCT00558428|141280349|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.68|STANDARD_ERROR_OF_MEAN|0.64||||95.0|-3.93|-1.43|||ANCOVA|Adjusted for baseline and country effect||||-1.43|-3.93|
70895995|NCT05224050|141280364|OTHER|A paired-samples t-test was conducted to examine differences in the DASS-21 total score from baseline to 2-weeks post-quit.|Mean Difference (Final Values)|-2.04|STANDARD_DEVIATION|10.54||0.4|TWO_SIDED|95.0|-6.98|2.89||The threshold for statistical significance was p\<0.05|t-test, 2 sided||Mean difference represents the difference of the mean for the DASS-21 total scores at Baseline and at 2-weeks post-quit. The reported estimated value is based on data from the n=20 who attended their 2-weeks post-quit session|||2.89|-6.98|0.40
70895996|NCT05224050|141280364|OTHER|A paired-samples t-test was conducted to examine the difference in the DASS-21 total scores from 2-weeks post-quit to 1-month post-quit.|Mean Difference (Final Values)|-2.43|STANDARD_DEVIATION|9.15||0.26|TWO_SIDED|95.0|-6.84|1.98||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean DASS-21 total scores at 2-weeks post-quit and 1-month post-quit. The reported estimated value is based on data from the n=19 participants who attended their 1-month post-quit session.|||1.98|-6.84|0.26
70895997|NCT05224050|141280364|OTHER|A paired-samples t-test was conducted to examine the difference in the DASS-21 total scores from 1-month post-quit to 3-month follow up.|Mean Difference (Final Values)|-2.75|STANDARD_DEVIATION|6.49||0.11|TWO_SIDED|95.0|-6.21|0.71||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean DASS-21 total scores at 1-month post-quit and 3-month follow up. The reported estimated value is based on data from the n=16 participants who attended their 3-month follow up session.|||0.71|-6.21|0.11
70895998|NCT05224050|141280367|OTHER|A paired-samples t-test was conducted to compare changes in cigarettes smoked per day from Baseline to Quit Day.|Mean Difference (Final Values)|13.7|STANDARD_DEVIATION|8.63|<|0.001|TWO_SIDED|95.0|9.88|17.53||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the average difference in cigarettes smoked per day from Baseline to Quit Date. The reported estimated value is based on data from the n=22 participants who attended their Quit Date session.|||17.53|9.88|<0.001
70895999|NCT05224050|141280367|OTHER|A paired-samples t-test was used to evaluate smoking reduction in participants from Quit Date to 2-weeks Post-Quit.|Mean Difference (Final Values)|0.11|STANDARD_DEVIATION|2.02||0.8|TWO_SIDED|95.0|-0.83|1.06||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the average difference in cigarettes smoked per day from Quit Date to 2-weeks Post-Quit. The reported estimated value is based on data from the n=20 participants who attended their 2-weeks post-quit session.|||1.06|-0.83|0.80
70896000|NCT05224050|141280367|OTHER|A paired-samples t-test was used to evaluate smoking reduction in participants from 2-weeks post-quit to 1=month post-quit.|Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|2.97||0.97|TWO_SIDED|95.0|-1.41|1.45||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the average difference in cigarettes smoked per day from 2-weeks post-quit to 1-month post-quit. The reported estimated value is based on data from the n=19 participants who attended their 1-month post-quit session.|||1.45|-1.41|0.97
70896001|NCT05224050|141280367|OTHER|A paired-samples t-test was used to evaluate smoking reduction in participants from 1-month post-quit to 3-month follow-up.|Mean Difference (Final Values)|-2.17|STANDARD_DEVIATION|3.75||0.04|TWO_SIDED|95.0|-4.17|-0.17||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the average difference in cigarettes smoked per day from 1-month post-quit to 3-month follow-up. The reported estimated value is based on data from the n=16 participants who attended their 3-month follow-up session.|||-0.17|-4.17|0.04
70896002|NCT01627327|141280370|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.022||||0.201|TWO_SIDED|95.0|-0.012|0.055|||ANCOVA|||||0.055|-0.012|0.201
70896003|NCT01175850|141280373|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Z-test|Z-test of two proportions was used to compare treatment groups for all randomized subjects.||||||<0.001
70896004|NCT01175850|141280374|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
70896005|NCT01175850|141280375|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
70896006|NCT01175850|141280376|SUPERIORITY_OR_OTHER|||||||0.926|TWO_SIDED||||||Chi-squared|||||||0.926
70896007|NCT01175850|141280377|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
70896008|NCT01175850|141280378|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
70896009|NCT01175850|141280379|SUPERIORITY_OR_OTHER|||||||0.859|TWO_SIDED||||||Chi-squared|||||||0.859
70896010|NCT01175850|141280380|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Chi-squared|||||||>0.999
70896011|NCT01175850|141280381|SUPERIORITY_OR_OTHER|||||||0.096|TWO_SIDED||||||Chi-squared|||||||0.096
70896012|NCT01175850|141280382|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
70896013|NCT01175850|141280383|SUPERIORITY_OR_OTHER|||||||0.121|TWO_SIDED||||||Chi-squared|||||||0.121
70896014|NCT01175850|141280384|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Chi-squared|||||||0.001
70896015|NCT01175850|141280385|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
70896016|NCT01175850|141280386|SUPERIORITY_OR_OTHER|||||||0.095|TWO_SIDED||||||Chi-squared|||||||0.095
70896017|NCT01175850|141280387|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||Chi-squared|||||||0.590
70896018|NCT01175850|141280388|SUPERIORITY_OR_OTHER|||||||0.302|TWO_SIDED||||||Chi-squared|||||||0.302
70896019|NCT01175850|141280389|SUPERIORITY_OR_OTHER|||||||0.111|TWO_SIDED||||||Chi-squared|||||||0.111
70896020|NCT01175850|141280390|SUPERIORITY_OR_OTHER|||||||0.103|TWO_SIDED||||||Chi-squared|||||||0.103
70896021|NCT01175850|141280391|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||Chi-squared|||||||0.049
70896022|NCT03901326|141280404|OTHER|||||||0.05|||||||Chi-squared|||Rate of ICA without obstructive CAD or intervention within 90 days||||0.05
70896023|NCT03901326|141280404|OTHER||||||<|0.001|||||||Chi-squared|||Rate of patients underwent revascularization||||<0.001
70896024|NCT03901326|141280405|OTHER||Hazard Ratio (HR)|0.88||||0.8|TWO_SIDED|95.0|0.59|1.3|||Regression, Cox|||||1.30|0.59|0.80
70896025|NCT03901326|141280406|OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
70896026|NCT03901326|141280407|OTHER|||||||0.15|||||||t-test, 2 sided|||||||0.15
70896027|NCT01692782|141280419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.7|||||TWO_SIDED||||||Mixed Models Analysis|||The 4 mg and 8 mg SEP 225289 groups were compared to placebo using a MMRM analysis. The MMRM model included treatment, visit (as a categorical variable), pooled center, baseline ADHD RS-IV with adult prompts score, and treatment-by-visit interaction. An unstructured covariance matrix was used for the within subject correlation.||||
70896028|NCT01692782|141280419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.38||||0.076|TWO_SIDED||||||Mixed Models Analysis|P-values of SEP 225289 4 mg versus placebo at Week 4 was adjusted for multiple comparisons using the Hochberg procedure.||The 4 mg SEP 225289 group was compared to placebo using a MMRM analysis. The MMRM model included treatment, visit (as a categorical variable), pooled center, baseline ADHD RS-IV with adult prompts score, and treatment-by-visit interaction. An unstructured covariance matrix was used for the within subject correlation.||||0.076
70896029|NCT01692782|141280419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.88||||0.019|TWO_SIDED|||||p-value of SEP 225289 8 mg versus placebo at Week 4 was adjusted for multiple comparisons using the Hochberg procedure.|Mixed Models Analysis|||The 8 mg SEP 225289 group was compared to placebo using a MMRM analysis. The MMRM model included treatment, visit (as a categorical variable), pooled center, baseline ADHD RS-IV with adult prompts score, and treatment-by-visit interaction. An unstructured covariance matrix was used for the within subject correlation.||||0.019
70896030|NCT03252587|141280425|SUPERIORITY||Odds Ratio (OR)|2.8||||0.0006|TWO_SIDED|95.0|1.5|5.1|||Regression, Logistic|1-sided||BMS-986165 3 mg vs Placebo||5.1|1.5|0.0006
70896031|NCT03252587|141280425|SUPERIORITY||Odds Ratio (OR)|1.9||||0.021|TWO_SIDED|95.0|1.0|3.4|||Regression, Logistic|1-sided||BMS-986165 6 mg vs Placebo||3.4|1.0|0.0210
70896032|NCT03252587|141280425|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0781|TWO_SIDED|95.0|0.8|2.9|||Regression, Logistic|1-sided||BMS-986165 12 mg vs Placebo||2.9|0.8|0.0781
70896033|NCT03252587|141280426|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0011|TWO_SIDED|95.0|1.4|4.8|||Regression, Logistic|1-sided||BMS-986165 3 mg vs Placebo||4.8|1.4|0.0011
70896034|NCT03252587|141280426|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0434|TWO_SIDED|95.0|0.9|3.1|||Regression, Logistic|1-sided||BMS-986165 6 mg vs Placebo||3.1|0.9|0.0434
70896035|NCT03252587|141280426|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0439|TWO_SIDED|95.0|0.9|3.1|||Regression, Logistic|1-sided||BMS-986165 12 mg vs Placebo||3.1|0.9|0.0439
70896036|NCT03252587|141280427|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0012|TWO_SIDED|95.0|1.4|5.1|||Regression, Logistic|1-sided||BMS-986165 3 mg vs Placebo||5.1|1.4|0.0012
70896037|NCT03252587|141280427|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0795|TWO_SIDED|95.0|0.8|3.0|||Regression, Logistic|1-sided||BMS-986165 6 mg vs Placebo||3.0|0.8|0.0795
70896038|NCT03252587|141280427|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0673|TWO_SIDED|95.0|0.9|3.2|||Regression, Logistic|1-sided||BMS-986165 12 mg vs Placebo||3.2|0.9|0.0673
70896039|NCT03252587|141280428|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0002|TWO_SIDED|95.0|1.9|8.5|||Regression, Logistic|1-sided||BMS-986165 3 mg vs Placebo||8.5|1.9|0.0002
70896040|NCT03252587|141280428|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0371|TWO_SIDED|95.0|0.9|4.5|||Regression, Logistic|1-sided||BMS-986165 6 mg vs Placebo||4.5|0.9|0.0371
70896041|NCT03252587|141280428|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0168|TWO_SIDED|95.0|1.1|5.1|||Regression, Logistic|1-sided||BMS-986165 12 mg vs Placebo||5.1|1.1|0.0168
70896042|NCT03252587|141280429|SUPERIORITY||Odds Ratio (OR)|10.5||||0.0006|TWO_SIDED|95.0|2.5|43.0|||Regression, Logistic|1-sided||BMS-986165 3 mg vs Placebo||43.0|2.5|0.0006
70896043|NCT03252587|141280429|SUPERIORITY||Odds Ratio (OR)|5.7||||0.0058|TWO_SIDED|95.0|1.5|22.0|||Regression, Logistic|1-sided||BMS-986165 6 mg vs Placebo||22.0|1.5|0.0058
70896044|NCT03252587|141280429|SUPERIORITY||Odds Ratio (OR)|8.2||||0.0009|TWO_SIDED|95.0|2.2|31.0|||Regression, Logistic|1-sided||BMS-986165 12 mg vs Placebo||31.0|2.2|0.0009
70896045|NCT03252587|141280430|SUPERIORITY||Adjusted Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.04||0.0131|TWO_SIDED|95.0|-4.4|-0.3|||Longitudinal Repeated Measures|||Tender BMS-986165 3 mg vs Placebo||-0.3|-4.4|0.0131
70896046|NCT03252587|141280430|SUPERIORITY||Adjusted Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.04||0.4156|TWO_SIDED|95.0|-2.3|1.8|||Longitudinal Repeated Measures|||Tender BMS-986165 6 mg vs Placebo||1.8|-2.3|0.4156
70896047|NCT03252587|141280430|SUPERIORITY||Adjusted Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.09||0.0151|TWO_SIDED|95.0|-4.5|-0.2|||Longitudinal Repeated Measures|||Tender BMS-986165 12 mg vs Placebo||-0.2|-4.5|0.0151
70896048|NCT03252587|141280430|SUPERIORITY||Adjusted Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.45||0.0029|TWO_SIDED|95.0|-2.2|-0.4|||Longitudinal Repeated Measures|||Swollen BMS-986165 3 mg vs Placebo||-0.4|-2.2|0.0029
70896049|NCT03252587|141280430|SUPERIORITY||Adjusted Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.46||0.0516|TWO_SIDED|95.0|-1.6|0.2|||Longitudinal Repeated Measures|||Swollen BMS-986165 6 mg vs Placebo||0.2|-1.6|0.0516
70896050|NCT03252587|141280430|SUPERIORITY||Adjusted Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.48||0.0298|TWO_SIDED|95.0|-1.8|0.0|||Longitudinal Repeated Measures|||Swollen BMS-986165 12 mg vs Placebo||0.0|-1.8|0.0298
70896051|NCT03252587|141280430|SUPERIORITY||Adjusted Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.4||0.001|TWO_SIDED|95.0|-2.0|-0.5|||Longitudinal Repeated Measures|||Tender + Swollen BMS-986165 3 mg vs Placebo||-0.5|-2.0|0.0010
70896052|NCT03252587|141280430|SUPERIORITY||Adjusted Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.4||0.0343|TWO_SIDED|95.0|-1.5|0.1|||Longitudinal Repeated Measures|||Tender + Swollen BMS-986165 6 mg vs Placebo||0.1|-1.5|0.0343
70896053|NCT03252587|141280430|SUPERIORITY||Adjusted Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.42||0.005|TWO_SIDED|95.0|-1.9|-0.3|||Longitudinal Repeated Measures|||Tender + Swollen BMS-986165 12 mg vs Placebo||-0.3|-1.9|0.0050
70896054|NCT02161133|141280456|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.62||0.712|TWO_SIDED||||||Mixed Models Analysis|||||||0.712
70896055|NCT02161133|141280457|SUPERIORITY||Mean Difference (Final Values)|-6.18|STANDARD_ERROR_OF_MEAN|2.48||0.013|TWO_SIDED||||||Mixed Models Analysis|||||||0.013
70896056|NCT02161133|141280458|SUPERIORITY||Mean Difference (Final Values)|12.23|STANDARD_ERROR_OF_MEAN|10.45||0.244|TWO_SIDED||||||Mixed Models Analysis|||||||0.244
70896057|NCT02161133|141280459|SUPERIORITY||Mean Difference (Final Values)|-3.71|STANDARD_ERROR_OF_MEAN|1.95||0.057|TWO_SIDED||||||Mixed Models Analysis|||||||0.057
70896058|NCT02161133|141280460|SUPERIORITY||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|1.57||0.382|TWO_SIDED||||||Mixed Models Analysis|||||||0.382
70896059|NCT02161133|141280461|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.703|TWO_SIDED||||||Mixed Models Analysis|||||||0.703
70896060|NCT02161133|141280462|SUPERIORITY||Mean Difference (Final Values)|-1.88|STANDARD_ERROR_OF_MEAN|1.36||0.168|TWO_SIDED||||||Mixed Models Analysis|||||||0.168
70896061|NCT02161133|141280463|SUPERIORITY||Mean Difference (Final Values)|-7.28|STANDARD_ERROR_OF_MEAN|2.93||0.013|TWO_SIDED||||||Mixed Models Analysis|||||||0.013
70896062|NCT03945188|141280471|SUPERIORITY||Risk Difference (RD)|19.75|||<|0.001|TWO_SIDED|95.0|12.88|26.63|||Cochran-Mantel-Haenszel|||||26.63|12.88|<0.001
70896063|NCT03945188|141280472|SUPERIORITY||Risk Difference (RD)|25.39|||<|0.001|TWO_SIDED|95.0|18.42|32.36|||Cochran-Mantel-Haenszel|||||32.36|18.42|<0.001
70896064|NCT03945188|141280473|SUPERIORITY||Risk Difference (RD)|21.18|||<|0.001|TWO_SIDED|95.0|13.03|29.32|||Cochran-Mantel-Haenszel|||||29.32|13.03|<0.001
70896065|NCT03945188|141280474|SUPERIORITY||Risk Difference (RD)|26.69|||<|0.001|TWO_SIDED|95.0|18.99|34.39|||Cochran-Mantel-Haenszel|||||34.39|18.99|<0.001
70896066|NCT03945188|141280475|SUPERIORITY||Risk Difference (RD)|24.55|||<|0.001|TWO_SIDED|95.0|15.46|33.63|||Cochran-Mantel-Haenszel|||||33.63|15.46|<0.001
70896067|NCT03945188|141280476|SUPERIORITY||Risk Difference (RD)|24.89|||<|0.001|TWO_SIDED|95.0|16.17|33.6|||Cochran-Mantel-Haenszel|||||33.60|16.17|<0.001
70896068|NCT03945188|141280477|SUPERIORITY||Risk Difference (RD)|16.88|||<|0.001|TWO_SIDED|95.0|10.78|22.98|||Cochran-Mantel-Haenszel|||||22.98|10.78|<0.001
70896069|NCT03945188|141280478|SUPERIORITY||Risk Difference (RD)|18.39|||<|0.001|TWO_SIDED|95.0|11.39|25.39|||Cochran-Mantel-Haenszel|||||25.39|11.39|<0.001
70896070|NCT03945188|141280479|SUPERIORITY||Risk Difference (RD)|25.39|||<|0.001|TWO_SIDED|95.0|18.42|32.36|||Cochran-Mantel-Haenszel|||||32.36|18.42|<0.001
70896071|NCT03945188|141280480|SUPERIORITY||Risk Difference (RD)|15.84|||<|0.001|TWO_SIDED|95.0|10.66|21.03|||Cochran-Mantel-Haenszel|||||21.03|10.66|<0.001
70896072|NCT03945188|141280481|SUPERIORITY||Risk Difference (RD)|28.27|||<|0.001|TWO_SIDED|95.0|18.51|38.02|||Cochran-Mantel-Haenszel|||||38.02|18.51|<0.001
70896073|NCT03945188|141280482|SUPERIORITY||Risk Difference (RD)|24.93|||<|0.001|TWO_SIDED|95.0|15.79|34.07|||Cochran-Mantel-Haenszel|||||34.07|15.79|<0.001
70896074|NCT03945188|141280483|SUPERIORITY||Risk Difference (RD)|26.16|||<|0.001|TWO_SIDED|95.0|17.48|34.84|||Cochran-Mantel-Haenszel|||||34.84|17.48|<0.001
70896075|NCT03945188|141280484|SUPERIORITY||Risk Difference (RD)|11.32|||<|0.001|TWO_SIDED|95.0|6.49|16.14|||Cochran-Mantel-Haenszel|||||16.14|6.49|<0.001
70896076|NCT03945188|141280485|SUPERIORITY||Risk Difference (RD)|10.23|||<|0.001|TWO_SIDED|95.0|4.73|15.73|||Cochran-Mantel-Haenszel|||||15.73|4.73|<0.001
70896077|NCT03945188|141280486|SUPERIORITY||Risk Difference (RD)|20.39|||<|0.001|TWO_SIDED|95.0|13.79|26.98|||Cochran-Mantel-Haenszel|||||26.98|13.79|<0.001
70896078|NCT03945188|141280487|SUPERIORITY||Risk Difference (RD)|9.16|||<|0.001|TWO_SIDED|95.0|4.93|13.38|||Cochran-Mantel-Haenszel|||||13.38|4.93|<0.001
70896079|NCT03945188|141280488|SUPERIORITY||Risk Difference (RD)|6.49|||=|0.049|TWO_SIDED|95.0|0.02|12.95|||Cochran-Mantel-Haenszel|||Week 2||12.95|0.02|=0.049
70896080|NCT03945188|141280488|SUPERIORITY||Risk Difference (RD)|15.03|||<|0.001|TWO_SIDED|95.0|7.32|22.74|||Cochran-Mantel-Haenszel|||Week 4||22.74|7.32|<0.001
70896081|NCT03945188|141280488|SUPERIORITY||Risk Difference (RD)|16.85|||<|0.001|TWO_SIDED|95.0|8.06|25.63|||Cochran-Mantel-Haenszel|||Week 8||25.63|8.06|<0.001
70896082|NCT03945188|141280488|SUPERIORITY||Risk Difference (RD)|21.66|||<|0.001|TWO_SIDED|95.0|12.71|30.61|||Cochran-Mantel-Haenszel|||Week 16||30.61|12.71|<0.001
70896083|NCT03945188|141280488|SUPERIORITY||Risk Difference (RD)|23.74|||<|0.001|TWO_SIDED|95.0|14.98|32.51|||Cochran-Mantel-Haenszel|||Week 20||32.51|14.98|<0.001
70896084|NCT03945188|141280488|SUPERIORITY||Risk Difference (RD)|21.04|||<|0.001|TWO_SIDED|95.0|11.83|30.24|||Cochran-Mantel-Haenszel|||Week 24||30.24|11.83|<0.001
70896085|NCT03945188|141280488|SUPERIORITY||Risk Difference (RD)|25.82|||<|0.001|TWO_SIDED|95.0|17.08|34.56|||Cochran-Mantel-Haenszel|||Week 32||34.56|17.08|<0.001
70896086|NCT03945188|141280488|SUPERIORITY||Risk Difference (RD)|23.47|||<|0.001|TWO_SIDED|95.0|14.8|32.14|||Cochran-Mantel-Haenszel|||Week 40||32.14|14.80|<0.001
70896087|NCT03945188|141280488|SUPERIORITY||Risk Difference (RD)|26.37|||<|0.001|TWO_SIDED|95.0|17.92|34.82|||Cochran-Mantel-Haenszel|||Week 48||34.82|17.92|<0.001
70896088|NCT03945188|141280489|SUPERIORITY||Risk Difference (RD)|3.59|||=|0.057|TWO_SIDED|95.0|-0.11|7.3|||Cochran-Mantel-Haenszel|||Week 2||7.30|-0.11|=0.057
70896089|NCT03945188|141280489|SUPERIORITY||Risk Difference (RD)|6.88|||=|0.007|TWO_SIDED|95.0|1.86|11.9|||Cochran-Mantel-Haenszel|||Week 4||11.90|1.86|=0.007
70896090|NCT03945188|141280489|SUPERIORITY||Risk Difference (RD)|10.14|||=|0.001|TWO_SIDED|95.0|4.09|16.2|||Cochran-Mantel-Haenszel|||Week 8||16.20|4.09|=0.001
70896091|NCT03945188|141280489|SUPERIORITY||Risk Difference (RD)|16.36|||<|0.001|TWO_SIDED|95.0|9.89|22.83|||Cochran-Mantel-Haenszel|||Week 12||22.83|9.89|<0.001
70896092|NCT03945188|141280489|SUPERIORITY||Risk Difference (RD)|15.37|||<|0.001|TWO_SIDED|95.0|9.23|21.52|||Cochran-Mantel-Haenszel|||Week 16||21.52|9.23|<0.001
70896093|NCT03945188|141280489|SUPERIORITY||Risk Difference (RD)|17.8|||<|0.001|TWO_SIDED|95.0|11.85|23.75|||Cochran-Mantel-Haenszel|||Week 20||23.75|11.85|<0.001
70896094|NCT03945188|141280489|SUPERIORITY||Risk Difference (RD)|14.24|||<|0.001|TWO_SIDED|95.0|7.45|21.04|||Cochran-Mantel-Haenszel|||Week 24||21.04|7.45|<0.001
70896095|NCT03945188|141280489|SUPERIORITY||Risk Difference (RD)|20.03|||<|0.001|TWO_SIDED|95.0|14.25|25.81|||Cochran-Mantel-Haenszel|||Week 32||25.81|14.25|<0.001
70896096|NCT03945188|141280489|SUPERIORITY||Risk Difference (RD)|15.13|||<|0.001|TWO_SIDED|95.0|8.91|21.35|||Cochran-Mantel-Haenszel|||Week 40||21.35|8.91|<0.001
70896097|NCT03945188|141280489|SUPERIORITY||Risk Difference (RD)|17.52|||<|0.001|TWO_SIDED|95.0|12.16|22.87|||Cochran-Mantel-Haenszel|||Week 48||22.87|12.16|<0.001
70896098|NCT03945188|141280489|SUPERIORITY||Risk Difference (RD)|19.86|||<|0.001|TWO_SIDED|95.0|13.75|25.98|||Cochran-Mantel-Haenszel|||Week 52||25.98|13.75|<0.001
70896099|NCT03945188|141280490|SUPERIORITY||Risk Difference (RD)|4.83|||=|0.336|TWO_SIDED|95.0|-5.01|14.68|||Cochran-Mantel-Haenszel|||Week 2||14.68|-5.01|=0.336
70896100|NCT03945188|141280490|SUPERIORITY||Risk Difference (RD)|17.11|||<|0.001|TWO_SIDED|95.0|7.06|27.15|||Cochran-Mantel-Haenszel|||Week 4||27.15|7.06|<0.001
70896101|NCT03945188|141280490|SUPERIORITY||Risk Difference (RD)|20.17|||<|0.001|TWO_SIDED|95.0|10.15|30.19|||Cochran-Mantel-Haenszel|||Week 8||30.19|10.15|<0.001
70896102|NCT03945188|141280490|SUPERIORITY||Risk Difference (RD)|23.44|||<|0.001|TWO_SIDED|95.0|13.45|33.43|||Cochran-Mantel-Haenszel|||Week 12||33.43|13.45|<0.001
70896103|NCT03945188|141280490|SUPERIORITY||Risk Difference (RD)|25.25|||<|0.001|TWO_SIDED|95.0|15.67|34.83|||Cochran-Mantel-Haenszel|||Week 16||34.83|15.67|<0.001
70896104|NCT03945188|141280490|SUPERIORITY||Risk Difference (RD)|29.2|||<|0.001|TWO_SIDED|95.0|19.77|38.64|||Cochran-Mantel-Haenszel|||Week 20||38.64|19.77|<0.001
70896105|NCT03945188|141280490|SUPERIORITY||Risk Difference (RD)|26.08|||<|0.001|TWO_SIDED|95.0|16.47|35.69|||Cochran-Mantel-Haenszel|||Week 24||35.69|16.47|<0.001
70896106|NCT03945188|141280490|SUPERIORITY||Risk Difference (RD)|28.68|||<|0.001|TWO_SIDED|95.0|19.35|38.02|||Cochran-Mantel-Haenszel|||Week 32||38.02|19.35|<0.001
70896107|NCT03945188|141280490|SUPERIORITY||Risk Difference (RD)|28.43|||<|0.001|TWO_SIDED|95.0|19.3|37.55|||Cochran-Mantel-Haenszel|||Week 40||37.55|19.30|<0.001
70896108|NCT03945188|141280490|SUPERIORITY||Risk Difference (RD)|29.59|||<|0.001|TWO_SIDED|95.0|20.55|38.64|||Cochran-Mantel-Haenszel|||Week 48||38.64|20.55|<0.001
70896109|NCT03945188|141280490|SUPERIORITY||Risk Difference (RD)|26.43|||<|0.001|TWO_SIDED|95.0|17.18|35.68|||Cochran-Mantel-Haenszel|||Week 52||35.68|17.18|<0.001
70896110|NCT03945188|141280491|SUPERIORITY||Risk Difference (RD)|5.93|||=|0.24|TWO_SIDED|95.0|-3.96|15.81|||Cochran-Mantel-Haenszel|||Week 2||15.81|-3.96|=0.240
70896111|NCT03945188|141280491|SUPERIORITY||Risk Difference (RD)|17.5|||<|0.001|TWO_SIDED|95.0|7.48|27.53|||Cochran-Mantel-Haenszel|||Week 4||27.53|7.48|<0.001
70896112|NCT03945188|141280491|SUPERIORITY||Risk Difference (RD)|20.93|||<|0.001|TWO_SIDED|95.0|10.92|30.94|||Cochran-Mantel-Haenszel|||Week 8||30.94|10.92|<0.001
70896113|NCT03945188|141280491|SUPERIORITY||Risk Difference (RD)|24.13|||<|0.001|TWO_SIDED|95.0|14.15|34.1|||Cochran-Mantel-Haenszel|||Week 12||34.10|14.15|<0.001
70896114|NCT03945188|141280491|SUPERIORITY||Risk Difference (RD)|24.51|||<|0.001|TWO_SIDED|95.0|14.89|34.13|||Cochran-Mantel-Haenszel|||Week 16||34.13|14.89|<0.001
70896115|NCT03945188|141280491|SUPERIORITY||Risk Difference (RD)|29.57|||<|0.001|TWO_SIDED|95.0|20.13|39.01|||Cochran-Mantel-Haenszel|||Week 20||39.01|20.13|<0.001
70896116|NCT03945188|141280491|SUPERIORITY||Risk Difference (RD)|26.45|||<|0.001|TWO_SIDED|95.0|16.88|36.02|||Cochran-Mantel-Haenszel|||Week 24||36.02|16.88|<0.001
70896117|NCT03945188|141280491|SUPERIORITY||Risk Difference (RD)|29.35|||<|0.001|TWO_SIDED|95.0|20.01|38.68|||Cochran-Mantel-Haenszel|||Week 32||38.68|20.01|<0.001
70896118|NCT03945188|141280491|SUPERIORITY||Risk Difference (RD)|28.83|||<|0.001|TWO_SIDED|95.0|19.71|37.95|||Cochran-Mantel-Haenszel|||Week 40||37.95|19.71|<0.001
70896119|NCT03945188|141280491|SUPERIORITY||Risk Difference (RD)|30.0|||<|0.001|TWO_SIDED|95.0|20.97|39.03|||Cochran-Mantel-Haenszel|||Week 48||39.03|20.97|<0.001
70896120|NCT03945188|141280491|SUPERIORITY||Risk Difference (RD)|26.84|||<|0.001|TWO_SIDED|95.0|17.6|36.07|||Cochran-Mantel-Haenszel|||Week 52||36.07|17.60|<0.001
70896121|NCT03945188|141280492|SUPERIORITY||Risk Difference (RD)|23.05|||<|0.001|TWO_SIDED|95.0|10.2|35.9|||Cochran-Mantel-Haenszel|||||35.90|10.20|<0.001
70896122|NCT03945188|141280493|SUPERIORITY||Risk Difference (RD)|31.86|||<|0.001|TWO_SIDED|95.0|18.45|45.28|||Cochran-Mantel-Haenszel|||||45.28|18.45|<0.001
70896123|NCT04341116|141280499|SUPERIORITY||Median Difference (Final Values)|9.0|STANDARD_ERROR_OF_MEAN|8.5||0.28|TWO_SIDED|95.0|-6.5|27.0|||Fisher Exact|||||27|-6.5|.28
70896124|NCT04575467|141280561|SUPERIORITY||Mean absolute fat thickness difference|-4.77|STANDARD_DEVIATION|2.29|<|0.01|TWO_SIDED|95.0|-7.17|-2.37|||Paired t-test|||||-2.37|-7.17|<0.01
70896125|NCT04575467|141280561|SUPERIORITY||Mean absolute fat thickness difference|-4.85|STANDARD_DEVIATION|2.02|<|0.01|TWO_SIDED|95.0|-6.97|-2.73|||Paired t-test|||||-2.73|-6.97|<0.01
70896126|NCT04575467|141280561|SUPERIORITY||Mean absolute fat thickness difference|-2.98|STANDARD_DEVIATION|2.83|<|0.05|TWO_SIDED|95.0|-5.95|-0.01|||Paired t-test|||||-0.01|-5.95|<0.05
70896127|NCT04575467|141280562|SUPERIORITY||Mean absolute fat volume difference|-114.4|STANDARD_DEVIATION|54.88|<|0.01|TWO_SIDED|95.0|-171.99|-56.81|||Paired t-test|||||-56.81|-171.99|<0.01
70896128|NCT04575467|141280562|SUPERIORITY||Mean absolute fat volume difference|-155.2|STANDARD_DEVIATION|64.7|<|0.01|TWO_SIDED|95.0|-223.1|-87.3|||Paired t-test|||||-87.30|-223.10|<0.01
70896129|NCT04575467|141280562|SUPERIORITY||Mean absolute fat volume difference|-119.17|STANDARD_DEVIATION|113.11|<|0.05|TWO_SIDED|95.0|-237.86|-0.47|||Paired t-test|||||-0.47|-237.86|<0.05
70896130|NCT03565887|141280574|SUPERIORITY|The primary efficacy endpoints were tested sequentially. The Day 1 Hour 6 time point was tested first and if P\<0.05, the Day 14 Hour 2 time point was tested at a significance level of 0.05. If the Day 1 Hour 6 endpoint is statistically significant (at the 0.05 level) but Day 14 Hour 2 was not statistically significant (at the 0.05 level), the study will still be considered positive.|||||<|0.0001||||||If both primary endpoints (LPFT) are significant at 0.05 significance level, then the secondary efficacy endpoints (MRD) were also tested sequentially. Testing stopped if a P≥ 0.05 for a comparison.|ANCOVA|2 sided t-test with treatment as fixed factor and baseline as covariate.||A two group t-test with a 0.05 two-sided significance level had 90% power to detect a difference in LPFT means of 3.50 assuming that the common standard deviation was 6.0, when the sample sizes in the 2 groups were 94 and 47, respectively (a total sample size of 141).||||<0.0001
70896131|NCT03565887|141280575|SUPERIORITY|If both primary endpoints (LPFT) are significant at 0.05 significance level, then the secondary efficacy endpoints (MRD) were also tested sequentially. Testing stopped if a P≥ 0.05 for a comparison.|||||<|0.0151|||||||ANCOVA|||A two group t-test with a 0.05 two-sided significance level had 90% power to detect a difference in LPFT means of 3.50 assuming that the common standard deviation was 6.0, when the sample sizes in the 2 groups were 94 and 47, respectively (a total sample size of 141).||||<0.0151
70896132|NCT01967732|141280618|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|77.43|||||TWO_SIDED|95.0|62.69|95.63|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (THS 2.2 - Group 1:CC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of THS 2.2:CC) for Cmax, therefore, there was no statistical hypothesis to be tested for this objective.||95.63|62.69|
70896133|NCT01967732|141280619|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|74.47|||||TWO_SIDED|95.0|61.52|90.14|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (THS 2.2 - Group 1:CC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of THS 2.2:CC) for AUC(0-last), therefore, there was no statistical hypothesis to be tested for this objective.||90.14|61.52|
70896134|NCT01292239|141280634|SUPERIORITY_OR_OTHER||(see comment)|27.5|||<|0.0001|TWO_SIDED|95.0|14.38|40.56||The p-value was based on the asymptomatic distribution of the generalized Cochran-Mantel-Haenszel (CMH) statistic controlling for stratification factors.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for stratification factors (age and IL28B genotype).|The parameter estimated was the difference of stratum adjusted proportion between groups.|||40.56|14.38|<0.0001
70896135|NCT01292239|141280635|SUPERIORITY_OR_OTHER||(see comment)|32.6|||<|0.0001|TWO_SIDED|95.0|19.75|45.4||The p-value was based on the asymptomatic distribution of the generalized Cochran-Mantel-Haenszel (CMH) statistic controlling for stratification factors.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for stratification factors (age and IL28B genotype).|The parameter estimated was the difference of stratum adjusted proportion between groups.|||45.40|19.75|<0.0001
70896136|NCT00584727|141280655|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||Alternative hypothesis was senofilcon A toric was superior to etafilcon A sphere by having more eyes see 20/20||||<0.0001
70896137|NCT00584727|141280656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7155|STANDARD_ERROR_OF_MEAN|0.1334||||95.0|0.3625|0.7155|||Mixed Models Analysis||Mean difference was senofilcon A toric minus etafilcon A sphere.|Alternative hypothesis was senofilcon A toric was superior to etafilcon A sphere.||0.7155|0.3625|
70896138|NCT00584727|141280657|SUPERIORITY_OR_OTHER|||||||0.2161||95.0|||||Chi-squared|||Aletrnative hypothesis was senofilcon A toric was superior to alphafilcon A toric by having more eyes within 5 degrees.||||0.2161
70896139|NCT00584727|141280658|SUPERIORITY_OR_OTHER|||||||0.1328||95.0|||||Chi-squared|||Alternative hypothesis was senofilcon A toric was superior to alphafilcon A toric by having more eyes within 5 degrees||||0.1328
70896140|NCT00584727|141280659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.489|STANDARD_ERROR_OF_MEAN|0.1393||||95.0|0.1529|0.489|||Mixed Models Analysis||Mean difference was senofilcon A toric minus alphafilcon A toric|Alternative hypothesis was senofilcon A toric was superior to alphafilcon A toric.||0.4890|0.1529|
70896141|NCT00584727|141280660|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||Alternative hypothesis was senofilcon A toric was superior to etafilcon A sphere.||||<0.0001
70896142|NCT00377403|141280663|SUPERIORITY_OR_OTHER|||||||0.83||95.0||||The a priori threshold for statistical significnace was p less than or equal to 0.05|ANOVA|Adjusted for disease severity at baseline||We used analysis of variance, controlling for disease severity at baseline to test the null hypothesis that there was no difference between study groups at this point in time.||||0.83
70896143|NCT00736645|141280672|OTHER|||||||0.5137|||||||Wilcoxon (Mann-Whitney)|||||||0.5137
70896144|NCT00736645|141280672|OTHER|||||||0.8994|||||||Wilcoxon (Mann-Whitney)|||||||0.8994
70896145|NCT00736645|141280672|OTHER|||||||0.3463|||||||Wilcoxon (Mann-Whitney)|||||||0.3463
70896146|NCT00736645|141280673|OTHER|||||||0.2609|||||||Wilcoxon (Mann-Whitney)|||||||0.2609
70896147|NCT00736645|141280673|OTHER|||||||0.7504|||||||Wilcoxon (Mann-Whitney)|||||||0.7504
70896148|NCT00736645|141280673|OTHER|||||||0.9727|||||||Wilcoxon (Mann-Whitney)|||||||0.9727
70896149|NCT00295022|141280674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.12|||<|0.001|TWO_SIDED|95.0|-4.35|-1.88|||ANCOVA|||||-1.88|-4.35|<0.001
70896150|NCT00295022|141280674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|||=|0.001|TWO_SIDED|95.0|-2.04|0.18|||ANCOVA|||||0.18|-2.04|=0.001
70896151|NCT00295022|141280674|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.19|||<|0.001|TWO_SIDED|95.0|-3.43|-0.95|||ANCOVA|||||-0.95|-3.43|<0.001
70896152|NCT01181050|141280702|SUPERIORITY_OR_OTHER||Treatment difference|-0.02||||0.9334||95.0|-0.54|0.5|||Mixed effect model repeated measures|||||0.50|-0.54|0.9334
70896153|NCT01181050|141280703|SUPERIORITY_OR_OTHER||Treatment difference|0.06||||0.8293||95.0|-0.46|0.58|||Mixed effect model repeated measures|||||0.58|-0.46|0.8293
70896154|NCT01181050|141280704|SUPERIORITY_OR_OTHER||Treatment difference|-0.04||||0.8867||95.0|-0.65|0.56|||Mixed effect model repeated measures|||||0.56|-0.65|0.8867
70896155|NCT01018394|141280705|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9||||0.108|TWO_SIDED|95.0|0.7|5.1||A one tailed P of less than 0.2 was considered sufficient evidence to warrant a larger study.|Fisher Exact|1 tailed||The percentage of participants who reduced tobacco use by greater or equal to 50% from baseline was compared between groups using Fisher's exact test. A one tailed P of less than 0.2 was considered sufficient evidence to warrant a larger study.||5.1|0.7|0.108
70896156|NCT03240692|141280714|OTHER|||||||0.036||||||False Discovery Corrected (FDR) p value. A p-value of ≤ 0.05 was considered to be statistically significant.|t-test, 2 sided|||Analysis of subgenual Anterior Cingulate Cortex (sgACC) and frontal Default Mode Network (fDMN) functional connectivity||||0.036
70896157|NCT03240692|141280714|OTHER|||||||0.008||||||False Discovery Corrected (FDR) p value. A p-value of ≤ 0.05 was considered to be statistically significant.|t-test, 2 sided|||Analysis of subgenual Anterior Cingulate Cortex (sgACC) and medial Default Mode Network (mDMN) functional connectivity||||0.008
70896158|NCT03240692|141280714|OTHER|||||||0.06||||||False Discovery Corrected (FDR) p value. A p-value of ≤ 0.05 was considered to be statistically significant.|t-test, 2 sided|||Analysis of subgenual Anterior Cingulate Cortex (sgACC) and left Default Mode Network (lDMN) functional connectivity.||||0.06
70896159|NCT03240692|141280714|OTHER|||||||0.017||||||False Discovery Corrected (FDR) p value. A p-value of ≤ 0.05 was considered to be statistically significant.|t-test, 2 sided|||Analysis of subgenual Anterior Cingulate Cortex (sgACC) and right Default Mode Network (rDMN) functional connectivity.||||0.017
70896160|NCT00683644|141280716|OTHER|The observed power in THQ for zinc is 0.16, and that for placebo is 0.06.|||||>|0.05||||||Threshold for significance is 0.05|Chi-squared|||||||>0.05
70896161|NCT00683644|141280717|OTHER|||||||0.89||||||Threshold for significance is 0.05|paired t test|||||||0.89
70896162|NCT00683644|141280717|OTHER|||||||0.36||||||Threshold for significance is 0.05|paired t test|||||||0.36
70896163|NCT00683644|141280718|OTHER|||||||0.64||||||Threshold for significance is 0.05|paired t test|||||||0.64
70896164|NCT00683644|141280718|OTHER|||||||0.93||||||Threshold for significance is 0.05|paired t test|||||||0.93
70896165|NCT01565707|141280736|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|12.1|STANDARD_ERROR_OF_MEAN|6.0||0.046|TWO_SIDED|95.0|0.2|24.0|||ANCOVA|From an ANCOVA (analysis of covariance) model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||"The following hypotheses were tested at the 2-sided significance level 0.05:~* H0: Change from baseline to EoT in mean MVV per micturition is the same for placebo and solifenacin succinate oral suspension~* H1: Change from baseline to EoT in mean MVV per micturition is not the same for placebo and solifenacin succinate oral suspension"||24.0|0.2|0.046
70896166|NCT01565707|141280736|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-4.7|STANDARD_ERROR_OF_MEAN|15.7|||TWO_SIDED|95.0|-36.7|27.4|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||27.4|-36.7|
70896167|NCT01565707|141280737|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|31.9|STANDARD_ERROR_OF_MEAN|13.9||0.024|TWO_SIDED|95.0|4.3|59.5|||ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||59.5|4.3|0.024
70896168|NCT01565707|141280737|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-17.3|STANDARD_ERROR_OF_MEAN|29.1|||TWO_SIDED|95.0|-76.5|41.9|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||41.9|-76.5|
70896169|NCT01565707|141280738|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.763|TWO_SIDED|95.0|-0.3|0.4||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.4|-0.3|0.763
70896170|NCT01565707|141280738|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-0.8|1.0|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||1.0|-0.8|
70896171|NCT01565707|141280739|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.402|TWO_SIDED|95.0|-0.5|0.3||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.3|-0.5|0.402
70896172|NCT01565707|141280739|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-1.5|0.4|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||0.4|-1.5|
70896173|NCT01565707|141280740|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.63|TWO_SIDED|95.0|0.0|0.2||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.2|0.0|0.630
70896174|NCT01565707|141280740|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.2|0.2|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate..|||0.2|-0.2|
70896175|NCT01565707|141280741|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.563|TWO_SIDED|95.0|-1.0|0.3||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.3|-1.0|0.563
70896176|NCT01565707|141280741|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|95.0|-1.6|1.9|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||1.9|-1.6|
70896177|NCT01565707|141280742|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.77|TWO_SIDED|95.0|-0.9|0.3||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.3|-0.9|0.770
70896178|NCT01565707|141280742|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-0.4|1.3|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||1.3|-0.4|
70896179|NCT01565707|141280743|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.303|TWO_SIDED|95.0|-0.8|0.2||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|ANCOVA|||||0.2|-0.8|0.303
70896180|NCT01565707|141280743|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-0.9|1.1|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||1.1|-0.9|
70896181|NCT01565707|141280744|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.3||0.64|TWO_SIDED|95.0|-0.8|0.5|||ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.5|-0.8|0.640
70896182|NCT01565707|141280744|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-0.9|1.4|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||1.4|-0.9|
70896183|NCT01565707|141280745|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.846|TWO_SIDED|95.0|-0.3|0.1||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.1|-0.3|0.846
70896184|NCT01565707|141280745|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-1.0|0.5|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||0.5|-1.0|
70896185|NCT01565707|141280746|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-1.4|0.8|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||0.8|-1.4|
70896186|NCT00126438|141280784|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36||||0.001|TWO_SIDED|95.0|0.18|0.73||At 0.025 level of significance.|Cox Proportional Hazards Model|||"Analysis based on Reader A readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time t was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.73|0.18|0.001
70896187|NCT00126438|141280784|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36||||0.001|TWO_SIDED|95.0|0.18|0.72||At 0.025 level of significance.|Cox Proportional Hazards Model|||"Analysis based on Reader B readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time t was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.72|0.18|0.001
70896188|NCT00126438|141280784|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35||||0.001|TWO_SIDED|95.0|0.17|0.72||At 0.025 level of significance.|Cox Proportional Hazards Model|||"Analysis based on Reader C readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time t was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.72|0.17|0.001
70896189|NCT01420848|141280785|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||It was used the Post Hoc and the statistical significance was p\<0.05.|ANOVA|||It was carried out the analysis of variance (ANOVA) among the groups at the 3rd (12 sessions) Hypothesis: there is at least one difference among the groups.||||0.006
70896190|NCT01420848|141280785|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||The statistical significance was p\<0.05.|ANOVA|||"It was verified the normality of data distribution and the homogeneity of variance.~It was carried out the analysis of variance (ANOVA) among the groups at the follow-up (after 15 days)."||||0.023
70896191|NCT01420848|141280786|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||After ANOVA it was performed Post Hoc Test and the statistical significance was p\<0.05.|ANOVA|||It was carried out the analysis of variance (ANOVA)of the medium difference among the groups in the 3rd (12 sessions) Hypothesis: there is at least one difference among the groups (State Anxiety)||||0.012
70896192|NCT01420848|141280786|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||After ANOVA, the Post Hoc Test was done and the statistical significance was p\<0.05.|ANOVA|||"It was carried out the analysis of variance (ANOVA) of the medium difference among the groups at the follow-up (after 15 days).~Hypothesis: there is at least one difference among the groups (State Anxiety)."||||0.005
70896193|NCT04154787|141280799|SUPERIORITY|Comparison of adjusted geometric mean ratios on Day 169|Adjusted geometric mean ratio|1.37||||0.267|TWO_SIDED|95.0|0.9|2.08||Calculated at one-sided 10% level from a lower-tailed test|Mixed Models Analysis|||||2.08|0.90|0.2670
70896194|NCT04154787|141280802|SUPERIORITY||Adjusted geometric mean ratios|0.81||||0.4598|TWO_SIDED|95.0|0.47|1.42||Calculated from a two-sided test at the 0.05 significance level|Mixed Model for Repeated Measures||Comparison of adjusted geometric mean ratios: Test vs Ref.|Day 15||1.42|0.47|0.4598
70896195|NCT04154787|141280802|SUPERIORITY||Geometric mean ratios|1.3||||0.4528|TWO_SIDED|95.0|0.65|2.61||Calculated from a two-sided test at the 0.05 significance level|Mixed Model for Repeated Measures||Comparison of adjusted geometric mean ratios: Test vs Ref.|Day 169||2.61|0.65|0.4528
70896196|NCT04171102|141280841|OTHER|||||||0.028||||||\<0.05|t-test, 2 sided|||||||0.028
70896197|NCT01751126|141280850|SUPERIORITY||LS Mean|0.76||||0.007|TWO_SIDED|95.0|0.26|1.27||ANCOVA with treatment as well as the baseline CFS and the exposure to Vernal keratoconjunctivitis (VKC) seasons (Hochberg procedure).|t-test, 2 sided|||||1.27|0.26|0.007
70896198|NCT01751126|141280850|SUPERIORITY||LS Mean|0.67||||0.01|TWO_SIDED|95.0|0.16|1.18|||ANCOVA|ANCOVA with treatment as well as the baseline CFS and the exposure to Vernal keratoconjunctivitis (VKC) seasons (Hochberg procedure).||||1.18|0.16|0.010
70896199|NCT02586025|141280861|SUPERIORITY||Difference in response rates|17.45||||0.0014|TWO_SIDED|95.0|6.89|28.01||Two-sided significance level of 5%|Cochran-Mantel-Haenszel|Stratified by disease category (early-stage and locally advanced) and hormone-receptor status (positive for ER and/or PgR or negative for both)|Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm. Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||28.01|6.89|0.0014
70896200|NCT02586025|141280862|SUPERIORITY||Difference in response rates|18.36||||0.0008|TWO_SIDED|95.0|7.89|28.83||Two-sided significance level of 5%|Cochran-Mantel-Haenszel|Stratified by disease category (early-stage and locally advanced) and hormone-receptor status (positive for ER and/or PgR or negative for both)|Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm. Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||28.83|7.89|0.0008
70896201|NCT02586025|141280863|SUPERIORITY||Difference in response rates|18.37||||0.001|TWO_SIDED|95.0|7.6|29.15||Two-sided significance level of 5%|Cochran-Mantel-Haenszel|Stratified by disease category (early-stage and locally advanced) and hormone-receptor status (positive for ER and/or PgR or negative for both)|Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm. Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||29.15|7.60|0.0010
70896202|NCT02586025|141280864|SUPERIORITY||Difference in response rates|18.83||||0.0006|TWO_SIDED|95.0|8.14|29.51||Two-sided significance level of 5%|Cochran-Mantel-Haenszel|Stratified by disease category (early-stage and locally advanced) and hormone-receptor status (positive for ER and/or PgR or negative for both)|Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm. Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||29.51|8.14|0.0006
70896203|NCT02586025|141280866|SUPERIORITY||Difference in response rates|10.4||||0.0125|TWO_SIDED|95.0|1.12|19.69||Two-sided significance level of 5%|Cochran-Mantel-Haenszel|Stratified by disease category (early-stage and locally advanced) and hormone-receptor status (positive for ER and/or PgR or negative for both)|Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm|||19.69|1.12|0.0125
70896204|NCT02586025|141280867|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.014|TWO_SIDED|95.0|0.32|0.89|||Stratified log-rank|Two-sided log-rank test used, stratified by disease category (early-stage/locally advanced) \& hormone-receptor status (ER+ \&/or PgR+ or ER- \& PgR-)|The hazard ratio was calculated by stratified Cox proportional hazards model.|Hazard Ratio for EFS Event in the Pertuzumab arm vs. Placebo arm||0.89|0.32|0.0140
70896205|NCT02586025|141280867|SUPERIORITY||Difference in EFS Event-Free Rates|-8.16||||0.0062|TWO_SIDED|95.0|-14.0|-2.32|||Z-test||The difference in EFS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in EFS Event-Free Rates at 1 year||-2.32|-14.00|0.0062
70896206|NCT02586025|141280867|SUPERIORITY||Difference in EFS Event-Free Rates|-9.17||||0.0429|TWO_SIDED|95.0|-18.05|-0.29|||Z-test||The difference in EFS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in EFS Event-Free Rates at 3 years||-0.29|-18.05|0.0429
70896207|NCT02586025|141280867|SUPERIORITY||Difference in EFS Event-Free Rates|-11.1||||0.0274|TWO_SIDED|95.0|-20.95|-1.24|||Z-test||The difference in EFS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in EFS Event-Free Rates at 5 Years||-1.24|-20.95|0.0274
70896208|NCT02586025|141280868|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.014|TWO_SIDED|95.0|0.3|0.88|||Stratified log-rank|Two-sided log-rank test used, stratified by disease category (early-stage/locally advanced) \& hormone-receptor status (ER+ \&/or PgR+ or ER- \& PgR-)|The hazard ratio was calculated by stratified Cox proportional hazards model.|Hazard Ratio for DFS Event in the Pertuzumab arm vs. Placebo arm||0.88|0.30|0.0140
70896209|NCT02586025|141280868|SUPERIORITY||Difference in DFS Event-Free Rates|-5.47||||0.0592|TWO_SIDED|95.0|-11.15|0.21|||Z-test||The difference in DFS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in DFS Event-Free Rates at 1 year||0.21|-11.15|0.0592
70896210|NCT02586025|141280868|SUPERIORITY||Difference in DFS Event-Free Rates|-9.0||||0.0426|TWO_SIDED|95.0|-17.69|-0.3|||Z-test||The difference in DFS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in DFS Event-Free Rates at 3 years||-0.30|-17.69|0.0426
70896211|NCT02586025|141280868|SUPERIORITY||Difference in DFS Event-Free Rates|-10.97||||0.0276|TWO_SIDED|95.0|-20.73|-1.21|||Z-test||The difference in DFS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in DFS Event-Free Rates at 5 years||-1.21|-20.73|0.0276
70896212|NCT02586025|141280869|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.1181|TWO_SIDED|95.0|0.23|1.19|||Stratified log-rank|Two-sided log-rank test used, stratified by disease category (early-stage/locally advanced) \& hormone-receptor status (ER+ \&/or PgR+ or ER- \& PgR-)|The hazard ratio was calculated by stratified Cox proportional hazards model.|Hazard Ratio for OS Event in the Pertuzumab arm vs. Placebo arm||1.19|0.23|0.1181
70896213|NCT02586025|141280869|SUPERIORITY||Difference in OS Event-Free Rates|0.46||||0.3162|TWO_SIDED|95.0|-0.44|1.36|||Z-test||The difference in OS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in OS Event-Free Rates at 1 year||1.36|-0.44|0.3162
70896214|NCT02586025|141280869|SUPERIORITY||Difference in OS Event-Free Rates|-6.02||||0.0529|TWO_SIDED|95.0|-12.11|0.08|||Z-test||The difference in OS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in OS Event-Free Rates at 3 years||0.08|-12.11|0.0529
70896215|NCT02586025|141280869|SUPERIORITY||Difference in OS Event-Free Rates|-3.89||||0.2616|TWO_SIDED|95.0|-10.69|2.9|||Z-test||The difference in OS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in OS Event-Free Rates at 5 years||2.90|-10.69|0.2616
70896216|NCT02586025|141280875|OTHER||Mean Difference (Final Values)|-0.35|||||TWO_SIDED|95.0|-1.62|0.93|||||Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm|||0.93|-1.62|
70896217|NCT01618162|141280881|SUPERIORITY_OR_OTHER||Estimated treatment difference|-1.02|||<|0.001|TWO_SIDED|95.0|-1.18|-0.87|||ANCOVA|||Superiority of IDegLira versus placebo therapy would be concluded if the 95% CI for the treatment differences for change in HbA1c lied entirely below 0%; implying that the two-sided p-value calculated by the ANCOVA model for testing the hypothesis of no difference between treatments was less than 5%.||-0.87|-1.18|< 0.001
70896218|NCT04124926|141280888|NON_INFERIORITY|The noninferiority of vonoprazan to lansoprazole was evaluated with a Farrington and Manning test with a noninferiority margin of 10 percentage points for the difference in EE rates between treatments (vonoprazan minus lansoprazole).|difference in percentage|8.3|||<|0.0001|TWO_SIDED|95.0|4.49|12.23||2-sided p-value.|Farrington and Manning test||The 2-sided 95% confidence interval (CI) of the difference in EE healing rates between vonoprazan 20 mg and lansoprazole 30 mg was calculated via the Miettinen and Nurminen method.|||12.23|4.49|<0.0001
70896219|NCT04124926|141280889|NON_INFERIORITY|The noninferiority of each dose group of vonoprazan to lansoprazole was evaluated with a Farrington and Manning test with a noninferiority margin of 10 percentage points for the difference in maintenance of healing rates between treatments (vonoprazan minus lansoprazole).|difference in percentage|8.7|||<|0.0001|TWO_SIDED|95.0|1.8|15.53||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in EE maintenance rates between each vonoprazan group and lansoprazole group was calculated via the Miettinen and Nurminen method.|||15.53|1.80|<0.0001
70896220|NCT04124926|141280889|NON_INFERIORITY|The noninferiority of each dose group of vonoprazan to lansoprazole was evaluated with a Farrington and Manning test with a noninferiority margin of 10 percentage points for the difference in maintenance of healing rates between treatments (vonoprazan minus lansoprazole).|difference in percentage|7.2|||<|0.0001|TWO_SIDED|95.0|0.21|14.09||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in EE maintenance rates between each vonoprazan group and lansoprazole group was calculated via the Miettinen and Nurminen method.|||14.09|0.21|<0.0001
70896221|NCT04124926|141280889|SUPERIORITY|The superiority of the vonoprazan 20 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.||||||0.0136||||||2-sided p-value.|Farrington and Manning test|||||||0.0136
70896222|NCT04124926|141280889|SUPERIORITY|The superiority of the vonoprazan 10 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.||||||0.0436||||||2-sided p-value.|Farrington and Manning test|||||||0.0436
70896223|NCT04124926|141280890|NON_INFERIORITY|If the lower bound of the CI was greater than -15%, noninferiority would be concluded.|difference in mean percentage|2.7|||||TWO_SIDED|95.0|-1.6|7.03|||||The 2-sided 95% CI of the difference in mean percentage of 24-hour heartburn-free days between vonoprazan 20 mg and lansoprazole 30 mg was calculated from Welch's t-test.|||7.03|-1.60|
70896224|NCT04124926|141280891|SUPERIORITY|The superiority of the vonoprazan 20 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|difference in percentage|17.6||||0.0008|TWO_SIDED|95.0|7.44|27.43||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in EE healing rates between vonoprazan 20 mg and lansoprazole 30 mg was calculated via the Miettinen and Nurminen method.|||27.43|7.44|0.0008
70896225|NCT04124926|141280892|SUPERIORITY|The superiority of the vonoprazan 20 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|difference in percentage|2.3||||0.4392|TWO_SIDED|95.0|-3.5|8.04||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in sustained resolution rates between vonoprazan 20 mg and lansoprazole 30 mg was calculated via the Miettinen and Nurminen method.|||8.04|-3.50|0.4392
70896226|NCT04124926|141280893|SUPERIORITY|Observed p-value and not a formal test per the preplanned fixed-sequence testing procedure. The superiority of the vonoprazan 20 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|difference in percentage|19.6|||<|0.0001|TWO_SIDED|95.0|11.84|27.58||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in EE healing rates between vonoprazan 20 mg and lansoprazole 30 mg was calculated via the Miettinen and Nurminen method.|||27.58|11.84|<0.0001
70896227|NCT04124926|141280894|SUPERIORITY|Observed p-value and not a formal test per the preplanned fixed-sequence testing procedure. The superiority of the vonoprazan 20 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|difference in percentage|6.1||||0.0348|TWO_SIDED|95.0|0.53|11.6||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in EE healing rates between vonoprazan 20 mg and lansoprazole 30 mg was calculated via the Miettinen and Nurminen method.|||11.60|0.53|0.0348
70896228|NCT04124926|141280895|SUPERIORITY|The superiority of the vonoprazan 20 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|difference in percentage|15.7||||0.0196|TWO_SIDED|95.0|2.5|28.44||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in maintenance rates between each vonoprazan group and lansoprazole 15 mg group was calculated via the Miettinen and Nurminen method.|||28.44|2.50|0.0196
70896229|NCT04124926|141280895|SUPERIORITY|The superiority of the vonoprazan 10 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|difference in percentage|13.3||||0.049|TWO_SIDED|95.0|0.02|26.14||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in maintenance rates between each vonoprazan group and lansoprazole 15 mg group was calculated via the Miettinen and Nurminen method.|||26.14|0.02|0.0490
70896230|NCT04124926|141280896|NON_INFERIORITY|If the lower bound of the CI was greater than -15%, noninferiority would be concluded.|difference in mean percentage|2.0|||||TWO_SIDED|95.0|-2.63|6.72|||||The 2-sided 95% CI of the difference in mean percentage of 24-hour heartburn-free days between each vonoprazan group and the lansoprazole group was calculated from Welch's t-test.|||6.72|-2.63|
70896231|NCT04124926|141280896|NON_INFERIORITY|If the lower bound of the CI was greater than -15%, noninferiority would be concluded.|difference in mean percentage|2.3|||||TWO_SIDED|95.0|-2.27|6.84|||||The 2-sided 95% CI of the difference in mean percentage of 24-hour heartburn-free days between each vonoprazan group and the lansoprazole group was calculated from Welch's t-test.|||6.84|-2.27|
70896232|NCT03871595|141280908|OTHER|Relative bioavailability|Adjusted Geometric Mean Ratio T/R [%]|99.51|STANDARD_DEVIATION|6.3|||TWO_SIDED|90.0|95.36|103.83|||||The Adjusted Geometric Mean is adjusted by treatment. The standard deviation is actually the intraindividual geometric Coefficient of Variation \[%\].|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'sequence' (fixed effect), 'subjects within sequences' (random effect), 'period' (fixed effect) and 'treatment' (fixed effect).||103.83|95.36|
70896233|NCT03871595|141280909|OTHER|Relative bioavailability|Adjusted Geometric Mean Ratio T/R [%]|70.11|STANDARD_DEVIATION|16.8|||TWO_SIDED|90.0|62.67|78.44|||||The Adjusted Geometric Mean is adjusted by treatment. The standard deviation is actually the intraindividual geometric Coefficient of Variation \[%\].|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'sequence' (fixed effect), 'subjects within sequences' (random effect), 'period' (fixed effect) and 'treatment' (fixed effect).||78.44|62.67|
70896234|NCT03871595|141280910|OTHER|Relative bioavailability|Adjusted Geometric Mean Ratio T/R [%]|99.78|STANDARD_DEVIATION|6.3|||TWO_SIDED|90.0|95.64|104.11|||||The Adjusted Geometric Mean is adjusted by treatment. The standard deviation is actually the intraindividual geometric Coefficient of Variation \[%\].|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'sequence' (fixed effect), 'subjects within sequences' (random effect), 'period' (fixed effect) and 'treatment' (fixed effect).||104.11|95.64|
70896235|NCT04435366|141280924|SUPERIORITY||Least Squares Mean Difference|0.056|STANDARD_ERROR_OF_MEAN|0.02||0.0064|TWO_SIDED|95.0|0.016|0.096||Nominal p-value was used for the comparison between avacincaptad pegol versus sham.|MMRM|||Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol). Mixed Model for repeated measures (MMRM) was used to compare the treatment groups.||0.096|0.016|0.0064
70896236|NCT04435366|141280925|SUPERIORITY||Least Squares Mean Difference|0.362|STANDARD_ERROR_OF_MEAN|0.15||0.0165|TWO_SIDED|95.0|0.066|0.657||Nominal p-value was used for the comparison between avacincaptad pegol versus sham.|MMRM|||Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol).||0.657|0.066|0.0165
70896237|NCT04435366|141280925|SUPERIORITY||Least Squares Mean Difference|0.488|STANDARD_ERROR_OF_MEAN|0.152||0.0015|TWO_SIDED|95.0|0.189|0.788||Nominal p-value was used for the comparison between avacincaptad pegol and sham versus sham.|MMRM|||Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol and sham).||0.788|0.189|0.0015
70896238|NCT04435366|141280926|SUPERIORITY||Least Squares Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.5||0.58|TWO_SIDED|95.0|-3.79|2.12||Nominal p-value was used for the comparison between avacincaptad pegol versus sham.|MMRM|||Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol).||2.12|-3.79|0.58
70896239|NCT04435366|141280927|SUPERIORITY||Least Squares Mean Difference|-1.49|STANDARD_ERROR_OF_MEAN|1.68||0.38|TWO_SIDED|95.0|-4.79|1.81||Nominal p-value was used for the comparison between avacincaptad pegol versus sham.|MMRM|||Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol).||1.81|-4.79|0.38
70896240|NCT04435366|141280929|SUPERIORITY||Least square mean difference|-0.712|STANDARD_ERROR_OF_MEAN|1.33||0.5929|TWO_SIDED|95.0|-3.326|1.903|||MMRM|||||1.903|-3.326|0.5929
70896241|NCT04435366|141280931|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.6424|TWO_SIDED|95.0|0.57|1.42|||Log Rank|||||1.42|0.57|0.6424
70896242|NCT05711641|141280932|OTHER|VAS was described with the use of summary measures, and the variations between the applied substances were compared with the use of Generalized Estimating Equations (GEE) with normal marginal distribution and identity binding function, assuming an interchangeable correlation matrix between the substances (McCullagh; Nelder, 1989).|Generalized Estimating Equations|||||||||||||||"The alternative hypothesis of this study is that 10% lidocaine, applied topically to the external auditory canal (EAC), acts on tinnitus intensity differently than placebo, while the null hypothesis is that there is no difference between the action of lidocaine and placebo on tinnitus intensity.~The analyses were performed using the IBM-SPSS for Windows software version 22.0 and tabulated using the Microsoft-Excel 2010 software, and the tests were performed with a significance level of 5%."|VAS was described with the use of summary measures, and the variations between the applied substances were compared with the use of Generalized Estimating Equations (GEE) with normal marginal distribution and identity binding function, assuming an interchangeable correlation matrix between the substances (McCullagh; Nelder, 1989).|||
70896243|NCT05711641|141280933|OTHER|Tinnitus loudness was described with the use of summary measures, and the variations between the applied substances were compared with the use of Generalized Estimating Equations (GEE) with normal marginal distribution and identity binding function, assuming an interchangeable correlation matrix between the substances (McCullagh; Nelder, 1989).||||||||||||||||"The alternative hypothesis of this study is that 10% lidocaine, applied topically to the external auditory canal (EAC), acts on tinnitus intensity differently than placebo, while the null hypothesis is that there is no difference between the action of lidocaine and placebo on tinnitus intensity.~The analyses were performed using the IBM-SPSS for Windows software version 22.0 and tabulated using the Microsoft-Excel 2010 software, and the tests were performed with a significance level of 5%."|Tinnitus loudness was described with the use of summary measures, and the variations between the applied substances were compared with the use of Generalized Estimating Equations (GEE) with normal marginal distribution and identity binding function, assuming an interchangeable correlation matrix between the substances (McCullagh; Nelder, 1989).|||
70896244|NCT05711641|141280934|OTHER|MML was described with the use of summary measures, and the variations between the applied substances were compared with the use of Generalized Estimating Equations (GEE) with normal marginal distribution and identity binding function, assuming an interchangeable correlation matrix between the substances (McCullagh; Nelder, 1989).||||||||||||||||"The alternative hypothesis of this study is that 10% lidocaine, applied topically to the external auditory canal (EAC), acts on tinnitus intensity differently than placebo, while the null hypothesis is that there is no difference between the action of lidocaine and placebo on tinnitus intensity.~The analyses were performed using the IBM-SPSS for Windows software version 22.0 and tabulated using the Microsoft-Excel 2010 software, and the tests were performed with a significance level of 5%."|MML was described with the use of summary measures, and the variations between the applied substances were compared with the use of Generalized Estimating Equations (GEE) with normal marginal distribution and identity binding function, assuming an interchangeable correlation matrix between the substances (McCullagh; Nelder, 1989).|||
70896245|NCT00989768|141280945|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_DEVIATION|0.36|<|0.0001||95.0|||||t-test, 2 sided|||In this study the null hypothesis was that BoNT-A1 had the same effect (halus)than the BoNT-A2.||||<0.0001
70896246|NCT00989768|141280946|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
70896247|NCT00989768|141280947|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||t-test, 2 sided|||||||0.61
70896248|NCT00989768|141280948|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||t-test, 2 sided|||||||0.36
70896249|NCT00162370|141280949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014|||||||Regression, Cox|||The null hypothesis evaluated is that the scores are not associated with outcome. Of the two measures, wall motion index is considered to be the primary endpoint measure. The cardiac event rate will be summarized by categorical levels of wall motion index score and the difference in wall motion index score.||||0.014
70896250|NCT00162370|141280950|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Regression, Cox|||||||<0.0001
70896251|NCT03492281|141280980|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.8|-0.2||Hypothesis testing was performed for vibegron minus placebo.|Mixed Model for Repeated Measures (MMRM)|||||-0.2|-0.8|<0.001
70896252|NCT03492281|141280980|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16|=|0.0988|TWO_SIDED|95.0|-0.6|0.1||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||0.1|-0.6|=0.0988
70896253|NCT03492281|141280981|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.9|-0.3||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||-0.3|-0.9|<0.0001
70896254|NCT03492281|141280981|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.15|=|0.0123|TWO_SIDED|95.0|-0.7|-0.1||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||-0.1|-0.7|=0.0123
70896255|NCT03492281|141280982|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.22|=|0.002|TWO_SIDED|95.0|-1.1|-0.2||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||-0.2|-1.1|=0.0020
70896256|NCT03492281|141280982|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.23|=|0.0648|TWO_SIDED|95.0|-0.9|0.0||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||0.0|-0.9|=0.0648
70896257|NCT03492281|141280983|SUPERIORITY||Difference in percentage|16.5|||<|0.0001|TWO_SIDED|95.0|9.7|23.4|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex (female/male), with weights proposed by Greenland and Robins.||||23.4|9.7|<0.0001
70896258|NCT03492281|141280983|SUPERIORITY||Difference in percentage|9.4|||=|0.012|TWO_SIDED|95.0|2.1|16.7|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex (female/male), with weights proposed by Greenland and Robins.||||16.7|2.1|=0.0120
70896259|NCT03492281|141280984|SUPERIORITY||Difference in percentage|6.3|||=|0.036|TWO_SIDED|95.0|0.4|12.1|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex (female/male), with weights proposed by Greenland and Robins.||||12.1|0.4|=0.0360
70896260|NCT03492281|141280984|SUPERIORITY||Difference in percentage|1.9|||=|0.5447|TWO_SIDED|95.0|-4.1|7.8|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex (female/male), with weights proposed by Greenland and Robins.||||7.8|-4.1|=0.5447
70896261|NCT03492281|141280985|SUPERIORITY||Difference in percentage|6.8|||=|0.0235|TWO_SIDED|95.0|0.9|12.7|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex and OAB type (wet/dry), with weights proposed by Greenland and Robins.||||12.7|0.9|=0.0235
70896262|NCT03492281|141280985|SUPERIORITY||Difference in percentage|3.7|||=|0.24|TWO_SIDED|95.0|-2.5|10.0|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex and OAB type (wet/dry), with weights proposed by Greenland and Robins.||||10.0|-2.5|=0.2400
70896263|NCT03492281|141280986|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.0|-0.4||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||-0.4|-1.0|<0.0001
70896264|NCT03492281|141280986|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17|=|0.0074|TWO_SIDED|95.0|-0.8|-0.1||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||-0.1|-0.8|=0.0074
70896265|NCT03492281|141280987|SUPERIORITY||Least Squares Mean Difference|3.6|STANDARD_ERROR_OF_MEAN|1.24|=|0.0039|TWO_SIDED|95.0|1.2|6.0||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||6.0|1.2|=0.0039
70896266|NCT03492281|141280987|SUPERIORITY||Least Squares Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|1.32|=|0.021|TWO_SIDED|95.0|0.5|5.7||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||5.7|0.5|=0.0210
70896267|NCT03492281|141280988|SUPERIORITY||Least Squares Mean Difference|21.2|STANDARD_ERROR_OF_MEAN|3.52|<|0.0001|TWO_SIDED|95.0|14.3|28.1||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||28.1|14.3|<0.0001
70896268|NCT03492281|141280988|SUPERIORITY||Least Squares Mean Difference|13.3|STANDARD_ERROR_OF_MEAN|3.76|<|0.001|TWO_SIDED|95.0|5.9|20.7||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||20.7|5.9|<0.001
70896269|NCT03492281|141280989|SUPERIORITY||Least Squares Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|1.06|<|0.001|TWO_SIDED|95.0|1.7|5.8||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||5.8|1.7|<0.001
70896270|NCT03492281|141280989|SUPERIORITY||Least Squares Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|1.13|=|0.0114|TWO_SIDED|95.0|0.6|5.1|||MMRM|||||5.1|0.6|=0.0114
70896271|NCT03492281|141280990|SUPERIORITY||Least Squares Mean Difference|-6.9|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-9.2|-4.6||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||-4.6|-9.2|<0.0001
70896272|NCT03492281|141280990|SUPERIORITY||Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|1.25|<|0.001|TWO_SIDED|95.0|-7.1|-2.2||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||-2.2|-7.1|<0.001
70896273|NCT03492281|141280991|SUPERIORITY||Difference in percentage|12.4|||<|0.0001|TWO_SIDED|95.0|6.7|18.1||CMH=Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel|The CMH risk difference estimate was stratified by OAB type (wet/dry) and sex (female/male), with weights proposed by Greenland and Robins.||||18.1|6.7|<0.0001
70896274|NCT03492281|141280991|SUPERIORITY||Difference in percentage|6.9|||=|0.0236|TWO_SIDED|95.0|0.9|12.8|||Cochran-Mantel-Haenszel|The CMH risk difference estimate was stratified by OAB type (wet/dry) and sex (female/male), with weights proposed by Greenland and Robins.||||12.8|0.9|=0.0236
70896275|NCT03492281|141280992|SUPERIORITY||Difference in percentage|11.7|||<|0.001|TWO_SIDED|95.0|4.7|18.6|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex (female/male), with weights proposed by Greenland and Robins.||||18.6|4.7|<0.001
70896276|NCT03492281|141280992|SUPERIORITY||Difference in percentage|11.5|||=|0.0022|TWO_SIDED|95.0|4.2|18.9|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex (female/male), with weights proposed by Greenland and Robins.||||18.9|4.2|=0.0022
70896277|NCT03492281|141280993|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.3|-0.1||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||-0.1|-0.3|<0.0001
70896278|NCT03492281|141280993|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.05|=|0.0055|TWO_SIDED|95.0|-0.2|0.0||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||0.0|-0.2|=0.0055
70896279|NCT03492281|141280994|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.4|-0.2||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||-0.2|-0.4|<0.0001
70896280|NCT03492281|141280994|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.3|-0.1||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||-0.1|-0.3|<0.001
70896281|NCT01506193|141280995|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with respect to seroconversion rates for measles was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|-0.04|||||TWO_SIDED|95.0|-1.82|2.78||||||"Immune response for anti-measles antibodies~Non-inferiority of Priorix-Tetra™ vaccine co-administered with Meningitec® conjugate vaccine compared to the first dose of Priorix-Tetra™ vaccine alone with respect to anti-measles seroconversion rates (SCRs) at Day 42 after dose 1."||2.78|-1.82|
70896282|NCT01506193|141280995|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with respect to seroconversion rates for mumps was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|1.29|||||TWO_SIDED|95.0|-3.04|6.67||||||"Immune response for anti-mumps antibodies~Non-inferiority of Priorix-Tetra™ vaccine co-administered with Meningitec® conjugate vaccine compared to the first dose of Priorix-Tetra™ vaccine alone with respect to anti-mumps seroconversion rates (SCRs) at Day 42 after dose 1."||6.67|-3.04|
70896283|NCT01506193|141280995|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with respect to seroconversion rates for rubella was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.23|2.29||||||"Immune response for anti-rubella antibodies~Non-inferiority of Priorix-Tetra™ vaccine co-administered with Meningitec® conjugate vaccine compared to the first dose of Priorix-Tetra™ vaccine alone with respect to anti-rubella seroconversion rates (SCRs) at Day 42 after dose 1."||2.29|-1.23|
70896284|NCT01506193|141280995|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with respect to seroconversion rates for varicella was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|-0.33|||||TWO_SIDED|95.0|-1.87|2.03||||||"Immune response for anti-varicella antibodies~Non-inferiority of Priorix-Tetra™ vaccine co-administered with Meningitec® conjugate vaccine compared to the first dose of Priorix-Tetra™ vaccine alone with respect to anti-varicella seroconversion rates (SCRs) at Day 42 after dose 1."||2.03|-1.87|
70896285|NCT01506193|141280996|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with respect to seroresponse for rSBA-MenC was concluded if the lower limit of the 95% CI around the difference in seroprotection rates between groups would be \[-10%\] or higher.|Difference in percentage|-1.02|||||TWO_SIDED|95.0|-3.39|2.24||||||"Immune response for rSBA-MenC antibodies~Non-inferiority of Meningitec® conjugate vaccine co-administered with Priorix-Tetra™ compared to Meningitec® conjugate vaccine alone with respect to rabbit complement serum bactericidal assay (rSBA-MenC) antibody seroprotection rates (SPRs) at Day 42 after vaccination."||2.24|-3.39|
70896286|NCT01570829|141281026|SUPERIORITY|||||||0.0352|||||||Fisher Exact|||||||0.0352
70896287|NCT01570829|141281027|SUPERIORITY|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||||||0.0001
70896288|NCT01570829|141281028|SUPERIORITY|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||||||0.0001
70896289|NCT01570829|141281029|SUPERIORITY|||||||0.0001|||||||Cochran-Mantel-Haenszel|Breslow-Day test p-value is 0.98||||||0.0001
70896290|NCT01570829|141281030|SUPERIORITY|||||||0.0004||||||"The p-value associated with treatment\*visit interaction of changes from baseline to Week 4, 8, 12, 16 and 20 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.0004
70896291|NCT01570829|141281031|SUPERIORITY|||||||0.0004||||||"The p-value associated with treatment\*visit interaction of changes from baseline to Week 4, 8, 12, 16 and 20 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.0004
70896292|NCT01570829|141281032|SUPERIORITY|||||||0.67||||||"The p-value associated with treatment\*visit interaction of changes from baseline to Week 4, 12, and 24 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||This analysis applies to rows with waist circumference data.||||0.67
70896293|NCT01570829|141281032|SUPERIORITY|||||||0.26||||||"The p-value associated with treatment\*visit interaction of changes from baseline to Week 4, 12, and 24 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||This analysis applies to rows with hip circumference data.||||0.26
70896294|NCT01570829|141281033|SUPERIORITY|||||||0.4||||||"The p-value associated with treatment\*visit interaction of changes from baseline to Week 4, 12, and 24 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||This analysis applies to rows with Physical Health domain data.||||0.40
70896295|NCT01570829|141281033|SUPERIORITY|||||||0.34||||||"The p-value associated with treatment\*visit interaction of changes from baseline to Week 4, 12, and 24 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||This analysis applies to rows with Mental Health domain data.||||0.34
70896296|NCT03364751|141281034|OTHER||LS Mean Difference|0.068||||0.297|TWO_SIDED|95.0|-0.06|0.196|||Mixed Models Analysis|||Month 6: Difference between Cigarette and IQOS||0.196|-0.060|0.297
70896297|NCT03364751|141281034|OTHER||LS Mean Difference|-0.064||||0.55|TWO_SIDED|95.0|-0.273|0.146|||Mixed Models Analysis|||Month 6: Difference between Cigarette and Dual Use||0.146|-0.273|0.550
70896298|NCT03364751|141281035|OTHER||LS Mean Difference|0.043||||0.502|TWO_SIDED|95.0|-0.084|0.171|||Mixed Models Analysis|||Month 3: Difference between Cigarette and IQOS||0.171|-0.084|0.502
70896299|NCT03364751|141281035|OTHER||LS Mean Difference|-0.02||||0.851|TWO_SIDED|95.0|-0.229|0.189|||Mixed Models Analysis|||Month 3: Difference between Cigarette and Dual Use||0.189|-0.229|0.851
70896300|NCT03364751|141281036|OTHER||LS Mean Difference|0.07||||0.376|TWO_SIDED|95.0|-0.085|0.224|||Mixed Models Analysis|||Month 3: Difference between Cigarette and IQOS||0.224|-0.085|0.376
70896301|NCT03364751|141281036|OTHER||LS Mean Difference|0.025||||0.848|TWO_SIDED|95.0|-0.229|0.279|||Mixed Models Analysis|||Month 3: Difference between Cigarette and DualUse||0.279|-0.229|0.848
70896302|NCT03364751|141281036|OTHER||LS Mean Difference|0.092||||0.246|TWO_SIDED|95.0|-0.064|0.247|||Mixed Models Analysis|||Month 6: Difference between Cigarette and IQOS||0.247|-0.064|0.246
70896303|NCT03364751|141281036|OTHER||LS Mean Difference|-0.105||||0.417|TWO_SIDED|95.0|-0.359|0.15|||Mixed Models Analysis|||Month 6: Difference between Cigarette and Dual Use||0.150|-0.359|0.417
70896304|NCT00675766|141281052|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -1.69 to 1.38. Range of z-scores at Year 1 follow-up: -1.28 to 1.36.||Repeated Measures ANOVA with overall neurocognitive performance at baseline and follow-up, computed as z-scored derived composite score of 14 individual neuropsychological measures assessing attention, processing speed, visuospatial skills, language, memory, executive function and motor skills, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||0.001
70896305|NCT00675766|141281052|SUPERIORITY_OR_OTHER||||||<|0.005|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -2.96 to 1.89. Range of z-scores at Year 1 follow-up: -1.89 to 1.77.||Repeated Measures ANOVA with processing speed at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing speed of cognitive information processing, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||<0.005
70896306|NCT00675766|141281052|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -2.30 to 2.44. Range of z-scores at Year 1 follow-up: -1.82 to 2.00.||Repeated Measures ANOVA with attention at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing attentional abilities, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||< 0.01
70896307|NCT00675766|141281052|SUPERIORITY_OR_OTHER||||||<|0.07|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -1.76 to 0.95. Range of z-scores at Year 1 follow-up: -1.18 to 0.84.||Repeated Measures ANOVA with executive function at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing working memory, set shifting, mental flexibility and problem solving, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||<0.07
70896308|NCT00675766|141281052|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -2.30 to 1.94. Range of z-scores at Year 1 follow-up: -1.83 to 2.11.||Repeated Measures ANOVA with language at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing verbal fluency and naming skills, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||0.09
70896309|NCT00675766|141281052|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -2.00 to 1.68. Range of z-scores at Year 1 follow-up: -2.33 to 1.90.||Repeated Measures ANOVA with memory at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing verbal and nonverbal learning and memory, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||.72
70896310|NCT00675766|141281052|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -2.04 to 2.51. Range of z-scores at Year 1 follow-up: -2.21 to 2.24.||Repeated Measures ANOVA with visuospatial skills at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing visuospatial and visuoconstructional abilities, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||0.65
70896311|NCT00675766|141281052|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -4.04 to 1.33. Range of z-scores at Year 1 follow-up: -1.24 to 2.37.||Repeated Measures ANOVA with motor skills at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing fine motor speed and dexterity, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||0.79
70896312|NCT00675766|141281052|SUPERIORITY_OR_OTHER|||||||0.044|ONE_SIDED||||||Fisher Exact|One-sided Fisher's exact test with 1 degree of freedom.||Fisher's exact test compared the frequency of older and younger HIV+ adults who converted from neurocognitively intact to neurocognitively impaired on memory over a one year time period. We hypothesized that the older group would exhibit a greater proportion of individuals who declined during this interim.||||.044
70896313|NCT02275065|141281055|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
70896314|NCT02275065|141281055|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
70896315|NCT02275065|141281055|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
70896316|NCT02275065|141281055|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
70896317|NCT02275065|141281058|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
70896318|NCT02275065|141281058|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
70896319|NCT02275065|141281058|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
70896320|NCT02275065|141281058|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
70896321|NCT02275065|141281059|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
70896322|NCT02275065|141281059|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
70896323|NCT02275065|141281059|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
70896324|NCT02275065|141281059|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
70896325|NCT01239030|141281097|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0046|||||||ANCOVA|||||||0.0046
70896326|NCT01201057|141281106|SUPERIORITY|||||||0.006|||||||Cochran-Mantel-Haenszel|||||||0.006
70896327|NCT01201057|141281107|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70896328|NCT01201057|141281108|SUPERIORITY|||||||0.025|||||||Cochran-Mantel-Haenszel|||||||0.025
70896329|NCT01662882|141281125|SUPERIORITY_OR_OTHER|||||||0.0253||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups.||||0.0253
70896330|NCT01662882|141281125|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups.||||0.0004
70896331|NCT01662882|141281125|SUPERIORITY_OR_OTHER|||||||0.4184||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups.||||0.4184
70896332|NCT01662882|141281125|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups.||||0.0008
70896333|NCT01662882|141281126|SUPERIORITY_OR_OTHER|||||||0.0039||95.0|||||ANOVA|||Analysis of variance P value testing for an overall difference in the mean cortical SUVR between the clinical diagnostic groups.||||0.0039
70896334|NCT01662882|141281126|SUPERIORITY_OR_OTHER|||||||0.0357||95.0|||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR||||0.0357
70896335|NCT01662882|141281126|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR||||0.0010
70896336|NCT01662882|141281126|SUPERIORITY_OR_OTHER|||||||0.2118||95.0|||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR||||0.2118
70896337|NCT00518115|141281131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.2968|TWO_SIDED|95.0|-0.18|0.59|||ANCOVA|||||0.59|-0.18|0.2968
70896338|NCT00518115|141281131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.186|TWO_SIDED|95.0|-0.64|0.12|||ANCOVA|||||0.12|-0.64|0.1860
70896339|NCT00518115|141281131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.0027|TWO_SIDED|95.0|-1.03|-0.22|||ANCOVA|||||-0.22|-1.03|0.0027
70896340|NCT00518115|141281131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.2766|TWO_SIDED|95.0|-0.62|0.18|||ANCOVA|||||0.18|-0.62|0.2766
70896341|NCT00518115|141281131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0057|TWO_SIDED|95.0|-0.94|-0.16|||ANCOVA|||||-0.16|-0.94|0.0057
70896342|NCT00518115|141281131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0032|TWO_SIDED|95.0|-0.96|-0.19|||ANCOVA|||||-0.19|-0.96|0.0032
70896343|NCT00518115|141281131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.0786|TWO_SIDED|95.0|-0.72|0.04|||ANCOVA|||||0.04|-0.72|0.0786
70896344|NCT00518115|141281131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.0022|TWO_SIDED|95.0|-0.99|-0.22|||ANCOVA|||||-0.22|-0.99|0.0022
70896345|NCT04891419|141281150|SUPERIORITY||Rate Difference|91.1|||<|0.0001|TWO_SIDED|95.0|83.7|95.9||P-value is based on the Fisher's Exact Test.|Fisher Exact||95% exact unconditional confidence interval for between-group difference in responder rate.|||95.9|83.7|<.0001
70896346|NCT04891419|141281151|SUPERIORITY||Control Difference|54.5|STANDARD_ERROR_OF_MEAN|2.69|<|0.0001|TWO_SIDED|95.0|49.2|59.9||P-value estimated using mixed effects model.|Mixed Models Analysis||95% CI estimated using mixed effects model.|||59.9|49.2|<.0001
70896347|NCT04891419|141281152|SUPERIORITY||Control Difference|42.8|STANDARD_ERROR_OF_MEAN|2.63|<|0.0001|TWO_SIDED|95.0|37.6|48.0||95% CI and p-value estimated using mixed effects model.|Mixed Models Analysis|||||48.0|37.6|<.0001
70896348|NCT04891419|141281153|SUPERIORITY||Rate Difference|93.1|||<|0.0001|TWO_SIDED|95.0|86.1|97.2||P-value is based on Fisher's Exact Test.|Fisher Exact||95% exact unconditional confidence interval for between-group difference in responder rate.|||97.2|86.1|<.0001
70896349|NCT04891419|141281154|SUPERIORITY||Rate Difference|92.1|||<|0.0001|TWO_SIDED|95.0|84.9|96.5||P-value is based on Fisher's Exact Test.|Fisher Exact||95% exact unconditional confidence interval for between-group difference in responder rate.|||96.5|84.9|<.0001
70896350|NCT00827918|141281155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.859|TWO_SIDED|95.0|-7.0|5.8|||Difference in the Least Squares Mean|||||5.8|-7.0|0.8590
70896351|NCT00827918|141281155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3||||0.2534|TWO_SIDED|95.0|-11.7|3.1|||Difference in the Least Squares Mean|||||3.1|-11.7|0.2534
70896352|NCT00827918|141281158|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.4976|TWO_SIDED|95.0|0.62|2.64|||Generalized linear mixed analysis model|||||2.64|0.62|0.4976
70896353|NCT00827918|141281158|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.0653|TWO_SIDED|95.0|0.95|5.09|||Generalized linear mixed analysis model|||||5.09|0.95|0.0653
70896354|NCT00827918|141281159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.8199|TWO_SIDED|95.0|-0.4|0.3|||Constrained longitudinal data analysis|||||0.3|-0.4|0.8199
70896355|NCT00827918|141281159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9486|TWO_SIDED|95.0|-0.4|0.4|||Constrained longitudinal data analysis|||||0.4|-0.4|0.9486
70896356|NCT00827918|141281160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9937|TWO_SIDED|95.0|-2.0|2.0|||Constrained longitudinal data analysis|||||2.0|-2.0|0.9937
70896357|NCT00827918|141281160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.2406|TWO_SIDED|95.0|-3.6|0.9|||Constrained longitudinal data analysis|||||0.9|-3.6|0.2406
70896358|NCT00827918|141281161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.5953|TWO_SIDED|95.0|-2.0|1.2|||Constrained longitudinal data analysis|||||1.2|-2.0|0.5953
70896359|NCT00827918|141281161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.8567|TWO_SIDED|95.0|-2.0|1.6|||Constrained longitudinal data analysis|||||1.6|-2.0|0.8567
70896360|NCT01311674|141281182|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.96
70896361|NCT01311674|141281183|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
70896362|NCT01311674|141281184|SUPERIORITY|||||||0.84|||||||Log Rank|||||||0.84
70896363|NCT01311674|141281185|SUPERIORITY|||||||0.24|||||||Log Rank|||||||0.24
70896364|NCT01311674|141281186|SUPERIORITY|||||||0.27|||||||Log Rank|||||||0.27
70896365|NCT00450411|141281187|OTHER|||||||||||||||||It was projected that ≤10% of patients would experience late treatment-related GI/GU AEs under the protocol treatment (alternative hypothesis). A rate of ≥20% was considered unacceptable (null hypothesis). With a one-sided significance level of 0.05, it was estimated that 87 analyzable patients were required to detect the above-mentioned effect size with an 85% statistical power using Fleming's multiple testing procedure with two interim analyses and one final analysis.|Stopping Rules for a Late GI/GU Adverse Event: For 44 patients, if ≤2 then reject H0, if ≥8 then reject HA; for 73 patients, if ≤7 then reject H0, if ≥10 then reject HA; for 87 patients, if ≤10 then reject H0, if ≥11 then reject HA.|||
70896366|NCT04184791|141281201|OTHER|A linear mixed-effects analysis of variance (LM-ANOVA) model was used to determine the effect of L-Dopa, frequency, the interaction of levodopa and frequency, and the interaction of frequency and contact pairs on gait parameters. The fixed effects were L-Dopa condition (ON vs. OFF), stimulation frequency (LFS;60 Hz vs. HFS;180 Hz), contact pairs \[1-(R)/1-(L); 2-(R)/2-(L); 3-(R)/3-(L); 4-(R)/4-(L)\], and assistive device (presence vs. absence) and the patient effect was considered random.|||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
70896367|NCT01297959|141281205|SUPERIORITY|||||||0.39|||||||Regression, Logistic|p-value was based on a logistic regression (Chi-square test) model with treatment group as a factor, adjusting for the stratification factors.||||||0.39
70896368|NCT01297959|141281206|SUPERIORITY|||||||0.34|||||||Regression, Logistic|p-value was based on a logistic regression (Chi-square test) model with treatment group as a factor, adjusting for the stratification factors.||||||0.34
70896369|NCT00818753|141281268|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||||95.0|0.08|12.76||p-values were not presented as the study was exploratory and not powered to to detect a difference in the treatments|Cochran-Mantel-Haenszel|||Dabigatran 110mg BID vs Heparin||12.76|0.08|
70896370|NCT00818753|141281268|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||||95.0|0.13|16.82||p-values were not presented as the study was exploratory and not powered to to detect a difference in the treatments|Cochran-Mantel-Haenszel|||Dabigatran 150mg BID vs Heparin||16.82|0.13|
70896371|NCT01712009|141281286|SUPERIORITY_OR_OTHER||Difference|-6.3|||||TWO_SIDED|95.0|-16.7|4.1|||||Naproxen minus No Prophylaxis|||4.1|-16.7|
70896372|NCT01712009|141281286|SUPERIORITY_OR_OTHER||Difference|-4.1|||||TWO_SIDED|95.0|-14.5|6.3|||||Loratadine minus No Prophylaxis|||6.3|-14.5|
70896373|NCT01712009|141281286|SUPERIORITY_OR_OTHER||Difference|2.2|||||TWO_SIDED|95.0|-8.0|12.4|||||Loratadine minus Naproxen|||12.4|-8.0|
70896374|NCT01712009|141281287|SUPERIORITY_OR_OTHER||Difference|-4.2|||||TWO_SIDED|95.0|-14.4|6.0|||||Naproxen minus No Prophylaxis|Difference across all treatment cycles||6.0|-14.4|
70896375|NCT01712009|141281287|SUPERIORITY_OR_OTHER||Difference|-2.4|||||TWO_SIDED|95.0|-12.5|7.8|||||Loratadine minus No Prophylaxis|Difference across all treatment cyces||7.8|-12.5|
70896376|NCT01712009|141281287|SUPERIORITY_OR_OTHER||Difference|1.8|||||TWO_SIDED|95.0|-8.3|12.0|||||Loratadine minus Naproxen|Dfference across all treatment cycles||12.0|-8.3|
70896377|NCT01712009|141281288|SUPERIORITY_OR_OTHER||Difference|-1.7|||||TWO_SIDED|95.0|-6.5|3.2|||||Naproxen minus No Prophylaxis|Difference across all treatment cycles||3.2|-6.5|
70896378|NCT01712009|141281288|SUPERIORITY_OR_OTHER||Difference|-1.3|||||TWO_SIDED|95.0|-6.1|3.6|||||Loratadine minus No Prophylaxis|Difference across all cycles||3.6|-6.1|
70896379|NCT01712009|141281288|SUPERIORITY_OR_OTHER||Difference|0.4|||||TWO_SIDED|95.0|-4.1|4.9|||||Loratadine minus Naproxen|Difference across all cycles||4.9|-4.1|
70896380|NCT01712009|141281289|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.0881|TWO_SIDED|95.0|-0.7|0.0|||ANOVA||Naproxen minus No Prophylaxis|Difference across all treatment cycles||0.0|-0.7|0.0881
70896381|NCT01712009|141281289|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_DEVIATION|0.2||0.0443|TWO_SIDED|95.0|-0.7|0.0|||ANOVA||Loratadine minus No Prophylaxis|Difference across all treatment cycles||-0.0|-0.7|0.0443
70896382|NCT01712009|141281289|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.8007|TWO_SIDED|95.0|-0.4|0.3|||ANOVA||Loratadine minus Naproxen|Difference across all treatment cycles||0.3|-0.4|0.8007
70896383|NCT01712009|141281290|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.1466|TWO_SIDED|95.0|-1.1|0.2|||ANOVA||Naproxen minus No Prophylaxis|Difference across all treatment cycles||0.2|-1.1|0.1466
70896384|NCT01712009|141281290|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0411|TWO_SIDED|95.0|-1.3|0.0|||ANOVA||Loratadine minus No Prophylaxis|Difference across all treatment cycles||-0.0|-1.3|0.0411
70896385|NCT01712009|141281290|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.5689|TWO_SIDED|95.0|-0.8|0.5|||ANOVA||Loratadine minus Naproxen|Difference across all treatment cycles||0.5|-0.8|0.5689
70896386|NCT01712009|141281291|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.8||0.0775||95.0|-3.0|0.2|||ANOVA||Naproxen minus No Prophylaxis|Difference across all treatment cycles||0.2|-3.0|0.0775
70896387|NCT01712009|141281291|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.8||0.0329|TWO_SIDED|95.0|-3.1|-0.1|||ANCOVA||Loratadine minus No Prophylaxis|Difference across all treatment cycles||-0.1|-3.1|0.0329
70896388|NCT01712009|141281291|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.7||0.7572|TWO_SIDED|95.0|-1.7|1.2|||ANOVA||Loratadine minus Naproxen|Difference across all treatment groups||1.2|-1.7|0.7572
70896389|NCT00785291|141281327|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.2||||0.054|TWO_SIDED|95.0|1.0|1.45||Tests were stratified by prior taxane therapy (yes/no) and hormone receptor status (positive/negative). P-values are for a test of inferiority 2-sided and are unadjusted for multiple comparisons.|Log Rank|||Stratified log-rank tests are used for the two primary comparisons of PFS within an experimental arm relative to PFS within the control arm. The family-wise error rate will be controlled at a one-sided 0.025 level. This is achieved in a 3-arm trial with a common control group by conducting the marginal log-rank tests with a one-sided α = 0.0135. Sample size calculations are based on having high power to detect a hazard ratio of 1.36, in the control arm as compared to the experimental arms.||1.45|1.00|0.054
70896390|NCT00785291|141281327|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.55|||<|0.0001|TWO_SIDED|95.0|1.28|1.87||Tests were stratified by prior taxane therapy (yes/no) and hormone receptor status (positive/negative). P-values are for a test of inferiority 2-sided and are unadjusted for multiple comparisons.|Log Rank|||Stratified log-rank tests are used for the two primary comparisons of PFS within an experimental arm relative to PFS within the control arm. The family-wise error rate will be controlled at a one-sided 0.025 level. This is achieved in a 3-arm trial with a common control group by conducting the marginal log-rank tests with a one-sided α = 0.0135. Sample size calculations are based on having high power to detect a hazard ratio of 1.36, in the control arm as compared to the experimental arms.||1.87|1.28|<0.0001
70896391|NCT00785291|141281331|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17||||0.2|TWO_SIDED|95.0|0.92|1.47||Tests were stratified by prior taxane therapy (yes/no) and hormone receptor status (positive/negative).|Log Rank|||||1.47|0.92|0.20
70896392|NCT00785291|141281331|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.28||||0.038|TWO_SIDED|95.0|1.01|1.61||Tests were stratified by prior taxane therapy (yes/no) and hormone receptor status (positive/negative).|Log Rank|||||1.61|1.01|0.038
70896393|NCT00844857|141281332|SUPERIORITY_OR_OTHER|||||||0.003||||||The a priori threshold for statistical significance was 0.05. Mixed Model Repeated Measures Analysis (MMRM) terms included baseline, country, treatment, visit, and treatment \* visit interaction.|Mixed Models Analysis|||"Tested was the null hypothesis that there was no difference in mean changes from baseline to Week 8 between OFC and placebo.~A conservative estimate of effect size of 0.4 was used in the sample size estimation for this study. A randomized ratio of 2:1 provided a 90% power with an effect size of 0.4."||||0.003
70896394|NCT00844857|141281333|SUPERIORITY_OR_OTHER|||||||0.035||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||0.035
70896395|NCT00844857|141281334|SUPERIORITY_OR_OTHER|||||||0.003||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||0.003
70896396|NCT00844857|141281335|SUPERIORITY_OR_OTHER|||||||0.007||||||The a priori threshold for statistical significance was 0.05. Ordinal Logistic Regression Model terms include baseline CDRS-R, baseline YMRS, and treatment.|Ordinal Logistic Regression|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||0.007
70896397|NCT00844857|141281336|SUPERIORITY_OR_OTHER|||||||0.527||||||The a priori threshold for statistical significance was 0.05. MMRM terms included baseline, country, treatment, visit, and treatment\*visit interaction.|Mixed Models Analysis|||Tested was the null hypothesis that there was no difference in mean changes from baseline to Week 8 between OFC and placebo.||||0.527
70896398|NCT00844857|141281337|SUPERIORITY_OR_OTHER|||||||0.03||||||The a priori threshold for statistical significance was 0.05. MMRM terms included baseline, country, treatment, visit, and treatment\*visit interaction|Mixed Models Analysis|||Tested was the null hypothesis that there was no difference in mean changes from baseline to Week 8 between OFC and placebo.||||0.030
70896399|NCT00844857|141281338|SUPERIORITY_OR_OTHER|||||||0.002||||||The a priori threshold for statistical significance was 0.05. ANCOVA (analysis of covariance) Model terms included baseline, country, and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||0.002
70896400|NCT00844857|141281339|SUPERIORITY_OR_OTHER|||||||1||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||1.00
70896401|NCT00844857|141281340|SUPERIORITY_OR_OTHER|||||||0.309||||||P-value for Suicidal Ideation. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||0.309
70896402|NCT00844857|141281340|SUPERIORITY_OR_OTHER|||||||0.667||||||P-value for Suicidal Behavior. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||0.667
70896403|NCT00844857|141281340|SUPERIORITY_OR_OTHER|||||||0.309||||||P-value for Suicidal Ideation or Behavior. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||0.309
70896404|NCT00844857|141281341|SUPERIORITY_OR_OTHER|||||||1||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||1.00
70896405|NCT00844857|141281342|SUPERIORITY_OR_OTHER|||||||0.545||||||P-value for ADHDRS-IV-PI Total Score. The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline, country and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||0.545
70896406|NCT00844857|141281343|SUPERIORITY_OR_OTHER|||||||0.066||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline, country and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||0.066
70896407|NCT00844857|141281344|SUPERIORITY_OR_OTHER|||||||1||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||1.00
70896408|NCT00844857|141281345|SUPERIORITY_OR_OTHER|||||||1||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||1.00
70896409|NCT00844857|141281346|SUPERIORITY_OR_OTHER|||||||0.05||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline, country and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||0.050
70896410|NCT00844857|141281347|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||<0.001
70896411|NCT00844857|141281348|SUPERIORITY_OR_OTHER|||||||0.98||||||P-value for Fasting Glucose. The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||0.980
70896412|NCT00844857|141281348|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for Fasting Cholesterol. The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||<0.001
70896413|NCT00844857|141281348|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for Fasting Triglycerides. The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||<0.001
70896414|NCT00844857|141281349|SUPERIORITY_OR_OTHER|||||||0.005||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||0.005
70896415|NCT00844857|141281350|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||<0.001
70896416|NCT00844857|141281351|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||<0.001
70896417|NCT00570674|141281358|OTHER||||||<|0.01|||||||Sign test|||||||<0.01
70896418|NCT00570674|141281359|OTHER||||||<|0.01|||||||Sign test|||||||<0.01
70896419|NCT00570674|141281360|OTHER|||||||0.52|||||||Sign test|||||||0.52
70896420|NCT00570674|141281361|OTHER|||||||0.39|||||||Sign test|||||||0.39
70896421|NCT05183022|141281362|SUPERIORITY|||||||0.07|||||||ANOVA|||||||0.07
70896422|NCT01466985|141281407|SUPERIORITY|Doravirine was declared superior to placebo when the upper bound of the 90% CI was \<-1.|Least squares (LS) mean difference|-1.37|||<|0.001||90.0|-1.6|-1.02|||ANCOVA|||||-1.02|-1.60|<0.001
70896423|NCT01466985|141281407|SUPERIORITY|Doravirine was declared superior to placebo when the upper bound of the 90% CI was \<-1.|LS mean difference|-1.26|||<|0.001|TWO_SIDED|90.0|-1.51|-1.02|||ANCOVA|||||-1.02|-1.51|<0.001
70896424|NCT05616962|141281412|SUPERIORITY|||||||0.473|||||||ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||0.473
70896425|NCT05616962|141281413|SUPERIORITY|||||||0.03199|||||||paired t-test|||||||0.03199
70896426|NCT05616962|141281414|SUPERIORITY|||||||0.408|||||||ANCOVA|ANCOVA with baseline value as covariate||||||0.408
70896427|NCT05616962|141281415|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
70896428|NCT05616962|141281416|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
70896429|NCT05616962|141281417|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
70896430|NCT05616962|141281418|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
70896431|NCT05616962|141281419|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
70896432|NCT05616962|141281420|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
70896433|NCT05616962|141281421|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
70896434|NCT05616962|141281422|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
70896435|NCT05616962|141281423|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
70896436|NCT05616962|141281424|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
70896437|NCT05616962|141281425|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
70896438|NCT05616962|141281426|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
70896439|NCT05616962|141281427|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
70896440|NCT05616962|141281428|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
70896441|NCT05616962|141281430|SUPERIORITY|||||||0.00463|||||||paired t-test|||||||0.00463
70896442|NCT05616962|141281431|SUPERIORITY|||||||0.23077|||||||paired t-test|||||||0.23077
70896443|NCT05616962|141281432|SUPERIORITY|||||||0.00849|||||||paired t-test|||||||0.00849
70896444|NCT00175825|141281460|SUPERIORITY_OR_OTHER||Percent reduction over Placebo|9.8|||=|0.24|TWO_SIDED|95.0|-7.2|24.0|||ANCOVA|||ANCOVA with baseline seizure frequency per week and each of the stratification factors as independent variables.||24.0|-7.2|=0.240
70896445|NCT00175825|141281460|SUPERIORITY_OR_OTHER||Percent reduction over Placebo|14.9|||=|0.062|TWO_SIDED|95.0|-0.8|28.2|||ANCOVA|||ANCOVA with baseline seizure frequency per week and each of the stratification factors as independent variables.||28.2|-0.8|=0.062
70896446|NCT00175825|141281460|SUPERIORITY_OR_OTHER||Percent reduction over Placebo|22.1|||=|0.004|TWO_SIDED|95.0|7.6|34.3|||ANCOVA|||ANCOVA with baseline seizure frequency per week and each of the stratification factors as independent variables.||34.3|7.6|=0.004
70896447|NCT00608582|141281461|SUPERIORITY_OR_OTHER||||||<|0.028||||||p\<0.05 considered significant|ANOVA|Post-hoc paired t-tests were performed.||A repeated measures ANOVA is performed with a significance level of p\<0.05 (two-sided). Factors: Time (Baseline vs. 2 Mo. Post rTMS treatment) and Group (Real vs. Sham).||||<0.028
70896448|NCT00608582|141281461|SUPERIORITY_OR_OTHER||||||<|0.05||||||p\<.05 considered significant; Pairwise comparisons not adjusted for multiple comparisons|t-test, 2 sided|||Paired, t-tests were performed if the ANOVA yields a significant interaction (p\<0.05, two-sided) for Baseline vs. 2 months after last rTMS treatment.||||<0.05
70896449|NCT00608582|141281461|SUPERIORITY_OR_OTHER||||||<|0.237||||||p\<0.05 considered significant. Pairwise comparisons were not corrected for multiple comparisons.|t-test, 2 sided|||Paired, t-tests were performed if the ANOVA yields a significant interaction (p\<0.05, two-sided) for Baseline vs. 2 Mo. after last Sham rTMS treatment.||||<0.237
70896450|NCT00608582|141281462|SUPERIORITY_OR_OTHER|||||||0.414||||||p\<0.05 considered significant|ANOVA|||A repeated measures ANOVA is performed with a significance level of p\<0.05 (two-sided). Factors: Time (Baseline vs. 2 months after last rTMS treatment) and Group (Real vs. Sham).||||0.414
70896451|NCT00608582|141281462|SUPERIORITY_OR_OTHER||||||<|0.822||||||p\<0.05 considered significant|ANOVA|||A repeated measures ANOVA is performed with a significance level of p\<0.05 (two-sided). Factors: Time (Baseline vs. 2 months after last rTMS treatment) and Group (Real vs. Sham).||||<0.822
70896452|NCT00608582|141281462|SUPERIORITY_OR_OTHER||||||<|0.835||||||p\<0.05 considered significant|ANOVA|||A repeated measures ANOVA is performed with a significance level of p\<0.05 (two-sided). Factors: Time (Baseline vs. 2 months after last rTMS treatment) and Group (Real vs. Sham).||||<0.835
70896453|NCT00160680|141281466|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.27|||=|0.667|TWO_SIDED|95.0|-0.96|1.5|||ANCOVA|||||1.50|-0.96|=0.667
70896454|NCT00985725|141281485|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.0||||0.0009|TWO_SIDED|95.0|-12.7|-3.3|||ANCOVA|||||-3.3|-12.7|0.0009
70896455|NCT00985725|141281486|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9||||0.0465|TWO_SIDED|95.0|-3.7|0.0|||ANCOVA|||||0.0|-3.7|0.0465
70896456|NCT00985725|141281487|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.1||||0.0181|TWO_SIDED|95.0|-9.4|-0.9|||ANCOVA|||Behavioral recognition index||-0.9|-9.4|0.0181
70896457|NCT00985725|141281487|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.2||||0.0204|TWO_SIDED|95.0|-7.7|-0.7|||ANCOVA|||Inhibit subscale||-0.7|-7.7|0.0204
70896458|NCT00985725|141281487|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.6||||0.009|TWO_SIDED|95.0|-9.8|-1.4|||ANCOVA|||Shift subscale||-1.4|-9.8|0.0090
70896459|NCT00985725|141281487|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.7||||0.0793|TWO_SIDED|95.0|-7.9|0.4|||ANCOVA|||Emotional control subscale||0.4|-7.9|0.0793
70896460|NCT00985725|141281487|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2||||0.1014|TWO_SIDED|95.0|-7.0|0.6|||ANCOVA|||Self-monitor subscale||0.6|-7.0|0.1014
70896461|NCT00985725|141281487|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.0||||0.0002|TWO_SIDED|95.0|-13.7|-4.3|||ANCOVA|||Metacognition index||-4.3|-13.7|0.0002
70896462|NCT00985725|141281487|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.6||||0.0002|TWO_SIDED|95.0|-12.9|-4.2|||ANCOVA|||Initiate subscale||-4.2|-12.9|0.0002
70896463|NCT00985725|141281487|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.1||||0.0001|TWO_SIDED|95.0|-13.7|-4.5|||ANCOVA|||Working memory subscale||-4.5|-13.7|0.0001
70896464|NCT00985725|141281487|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.5||||0.001|TWO_SIDED|95.0|-11.9|-3.1|||ANCOVA|||Plan/Organize subscale||-3.1|-11.9|0.0010
70896465|NCT00985725|141281487|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9||||0.0357|TWO_SIDED|95.0|-9.4|-0.3|||ANCOVA|||Task monitor subscale||-0.3|-9.4|0.0357
70896466|NCT00985725|141281487|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0||||0.0012|TWO_SIDED|95.0|-11.1|-2.8|||ANCOVA|||Organization of materials subscale||-2.8|-11.1|0.0012
70896467|NCT00985725|141281492|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.4||||0.1731|TWO_SIDED|95.0|-10.9|2.0|||ANCOVA|||||2.0|-10.9|0.1731
70896468|NCT02450331|141281504|SUPERIORITY||Hazard Ratio (HR)|0.892||||0.2446|TWO_SIDED|95.0|0.735|1.081|||Log Rank|||||1.081|0.735|0.2446
70896469|NCT02450331|141281505|SUPERIORITY||Hazard Ratio (HR)|0.897||||0.3172|TWO_SIDED|95.0|0.726|1.109|||Log Rank|||Stratified analysis based on PDL1 status, tumor stage after resection, and nodal status.||1.109|0.726|0.3172
70896470|NCT02450331|141281506|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.836||||0.2235|TWO_SIDED|95.0|0.626|1.116|||Log Rank|||||1.116|0.626|0.2235
70896471|NCT02450331|141281507|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.918||||0.4291|TWO_SIDED|95.0|0.743|1.134|||Log Rank|||||1.134|0.743|0.4291
70896472|NCT02450331|141281508|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.879||||0.1994|TWO_SIDED|95.0|0.722|1.07|||Log Rank|||||1.070|0.722|0.1994
70896473|NCT03232983|141281521|SUPERIORITY||Ratio of Geometric Least Squares Means|1.03|||||TWO_SIDED|90.0|0.992|1.07|||Mixed Models Analysis|||Geometric Least Squares Means (LSMeans) were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.07|0.992|
70896474|NCT03232983|141281521|SUPERIORITY||Ratio of Geometric Least Squares Means|1.0|||||TWO_SIDED|90.0|0.962|1.04|||Mixed Models Analysis|||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.04|0.962|
70896475|NCT03232983|141281522|SUPERIORITY||Ratio of Geometric LSMeans|1.09|||||TWO_SIDED|90.0|1.0|1.2|||Mixed Models Analysis|||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.20|1.00|
70896476|NCT03232983|141281522|SUPERIORITY||Ratio of Geometric LSMeans|1.14|||||TWO_SIDED|90.0|1.04|1.25|||Mixed Models Analysis|||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.25|1.04|
70896477|NCT01137474|141281542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.05|STANDARD_ERROR_OF_MEAN|0.9251||0.001|TWO_SIDED|95.0|-4.87|-1.24||Endpoint tested following a sequential testing procedure at two-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test performed since previous tests were significant.|Longitudinal repeated measures analysis|Only Week 12 data are presented; data from all weeks in double-blind period were included in the longitudinal repeated measures model.||Change from baseline to week 12 calculated using a longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata and continuous fixed covariates of baseline value and baseline value by week interaction. Data after rescue were not included in the analysis. With 253 patients per group, there is \>80% power to detect a difference of 3.5 mm Hg at alpha=0.05, assuming a common SD of 14 mm Hg.||-1.24|-4.87|0.0010
70896478|NCT01137474|141281543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.0673|<|0.0001|TWO_SIDED|95.0|-0.59|-0.33||Endpoint tested following a sequential testing procedure at two-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test performed since previous tests were significant.|Longitudinal repeated measures analysis|Only Week 12 data are presented; data from all weeks in the double-blind treatment period were included in the longitudinal repeated measures model||Change from baseline to week 12 was calculated using a longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata and continuous fixed covariates of baseline value and baseline value by week interaction. With 253 subjects per group, there is \>98% power to detect a difference of 0.4% at a=0.05, assuming a common SD of 1.1%.||-0.33|-0.59|<0.0001
70896479|NCT01137474|141281544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.89|STANDARD_ERROR_OF_MEAN|1.0091||0.0043|TWO_SIDED|95.0|-4.88|-0.91||Endpoint tested following a sequential testing procedure at 2-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test performed since previous tests were significant.|ANCOVA|Only Week 12 data are presented; data from all weeks in double-blind period were included in the longitudinal repeated measures model.||Change from baseline to week 12 LOCF was calculated using an ANCOVA model with treatment group as an effect and baseline value and randomization strata as covariate. Data after rescue are excluded from blood pressure analyses.||-0.91|-4.88|0.0043
70896480|NCT01137474|141281545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.5811||0.0843|TWO_SIDED|95.0|-2.15|0.14||Endpoint tested following a sequential testing procedure at two-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test performed since previous tests were significant.|Longitudinal repeated measures analysis|Only Week 12 data are presented; data from all weeks in double-blind period were included in the longitudinal repeated measures model.||Change from baseline to week 12 was calculated using a longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata and continuous fixed covariates of baseline value and baseline value by week interaction. Data after rescue were not included in the analysis.||0.14|-2.15|0.0843
70896481|NCT01137474|141281546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.6866|||TWO_SIDED|95.0|-1.96|0.73||Endpoint tested following a sequential testing procedure at 2-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test not performed since previous tests were not significant.|ANCOVA|||Change from baseline to week 12 LOCF was calculated using an ANCOVA model with treatment group as an effect and baseline value and randomization strata as covariate. Data after rescue are excluded from blood pressure analyses.||0.73|-1.96|
70896482|NCT01137474|141281547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.0717|||TWO_SIDED|95.0|-0.46|-0.18||Endpoint tested following a sequential testing procedure at two-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test not performed since previous tests were not significant.|Longitudinal repeated measures analysis|Only Week 12 data are presented; data from all weeks in double-blind period were included in the longitudinal repeated measures model.||Change from baseline to week 12 was calculated using a longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata and continuous fixed covariates of baseline value and baseline value by week interaction.||-0.18|-0.46|
70896483|NCT02219048|141281550|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0719|STANDARD_ERROR_OF_MEAN|0.0909|||TWO_SIDED|90.0|-0.2243|0.0805|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Change From Baseline at Week 1||0.0805|-0.2243|
70896484|NCT02219048|141281550|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.092|STANDARD_ERROR_OF_MEAN|0.086|||TWO_SIDED|90.0|-0.2362|0.0523|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Change From Baseline at Week 2||0.0523|-0.2362|
70896485|NCT02219048|141281550|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1131|STANDARD_ERROR_OF_MEAN|0.0837|||TWO_SIDED|90.0|-0.2536|0.0274|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Change From Baseline at Week 3||0.0274|-0.2536|
70896486|NCT02219048|141281550|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.058|STANDARD_ERROR_OF_MEAN|0.0829|||TWO_SIDED|90.0|-0.1971|0.0812|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Change From Baseline at Week 4||0.0812|-0.1971|
70896487|NCT02219048|141281550|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.0837|STANDARD_ERROR_OF_MEAN|0.0742|||TWO_SIDED|90.0|-0.2081|0.0406|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Change From Baseline Over Week 1 to 4||0.0406|-0.2081|
70896488|NCT02219048|141281553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|90.0|-0.285|0.106|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Change From Baseline Averaged Over Week 1 to 4||0.106|-0.285|
70896489|NCT02219048|141281555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.017|STANDARD_ERROR_OF_MEAN|10.003|||TWO_SIDED|90.0|-10.76|22.794|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Morning PEF: CFB at Week 1||22.794|-10.760|
70896490|NCT02219048|141281555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.591|STANDARD_ERROR_OF_MEAN|12.228|||TWO_SIDED|90.0|-13.926|27.108|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Morning PEF: CFB at Week 2||27.108|-13.926|
70896491|NCT02219048|141281555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.954|STANDARD_ERROR_OF_MEAN|11.673|||TWO_SIDED|90.0|-18.644|20.552|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Morning PEF: CFB at Week 3||20.552|-18.644|
70896492|NCT02219048|141281555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.368|STANDARD_ERROR_OF_MEAN|12.92|||TWO_SIDED|90.0|-26.069|17.333|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Morning PEF: CFB at Week 4||17.333|-26.069|
70896493|NCT02219048|141281555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.299|STANDARD_ERROR_OF_MEAN|10.503|||TWO_SIDED|90.0|-15.323|19.92|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Morning PEF: CFB Averaged Over 4 Weeks||19.920|-15.323|
70896494|NCT02219048|141281555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.135|STANDARD_ERROR_OF_MEAN|10.961|||TWO_SIDED|90.0|-17.248|19.519|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Evening PEF: CFB at Week 1||19.519|-17.248|
70896495|NCT02219048|141281555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.834|STANDARD_ERROR_OF_MEAN|9.956|||TWO_SIDED|90.0|-13.871|19.54|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Evening PEF: CFB at Week 2||19.540|-13.871|
70896496|NCT02219048|141281555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.374|STANDARD_ERROR_OF_MEAN|11.652|||TWO_SIDED|90.0|-27.933|11.185|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Evening PEF: CFB at Week 3||11.185|-27.933|
70896497|NCT02219048|141281555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.445|STANDARD_ERROR_OF_MEAN|13.573|||TWO_SIDED|90.0|-23.245|22.356|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Evening PEF: CFB at Week 4||22.356|-23.245|
70896498|NCT02219048|141281555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.212|STANDARD_ERROR_OF_MEAN|10.317|||TWO_SIDED|90.0|-18.52|16.096|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Evening PEF: CFB Averaged Over 4 Weeks||16.096|-18.520|
70896499|NCT04794803|141281558|SUPERIORITY||||||=|0.02164|||||||Log Rank|||||||= 0.02164
70896500|NCT04794803|141281558|SUPERIORITY||||||=|0.20043|||||||Log Rank|||Sensitivity analysis of time to event for each single component of the primary endpoint: Supplemental oxygen requirement based on PaO2/FiO2||||= 0.20043
70896501|NCT04794803|141281558|SUPERIORITY||||||=|0.30215|||||||Log Rank|||Sensitivity analysis of time to event for each single component of the primary endpoint: time to first invasive mechanical ventilation||||= 0.30215
70896502|NCT04794803|141281558|SUPERIORITY|||||||0.5637|||||||Log Rank|||Sensitivity analysis of time to event for each single component of the primary endpoint: time to first admission to ICU||||0.56370
70896503|NCT04794803|141281558|SUPERIORITY||||||=|0.00132|||||||Log Rank|||Sensitivity analysis of time to event for each single component of the primary endpoint: time to first use of a rescue medication for any reason||||= 0.00132
70896504|NCT04794803|141281559|SUPERIORITY|||||||0.731|||||||Fisher Exact|||comparison at week 1||||0.731
70896505|NCT04794803|141281559|SUPERIORITY|||||||1|||||||Fisher Exact|||at EOT||||1.000
70896506|NCT04794803|141281559|SUPERIORITY|||||||1|||||||Fisher Exact|||at EOS||||1.000
70896507|NCT04794803|141281560|SUPERIORITY|||||||0.353|||||||Fisher Exact|||at baseline||||0.353
70896508|NCT04794803|141281560|SUPERIORITY|||||||0.401|||||||Fisher Exact|||At Day 1||||0.401
70896509|NCT04794803|141281560|SUPERIORITY|||||||0.066|||||||Fisher Exact|||At Day 2||||0.066
70896510|NCT04794803|141281560|SUPERIORITY|||||||0.102|||||||Fisher Exact|||At week 1||||0.102
70896511|NCT04794803|141281560|SUPERIORITY|||||||0.314|||||||Fisher Exact|||at EOT||||0.314
70896512|NCT04794803|141281560|SUPERIORITY|||||||1|||||||Fisher Exact|||at EOS||||1.000
70896513|NCT04794803|141281561|SUPERIORITY||||||>|0.999||||||p-values are referred to a two-sided Wilcoxon test for differences in the change of VAS scale.|Wilcoxon (Mann-Whitney)|||Day 1 vs baseline||||>0.999
70896514|NCT04794803|141281561|SUPERIORITY||||||>|0.999||||||p-values are referred to a two-sided Wilcoxon test for differences in the change of VAS scale.|Wilcoxon (Mann-Whitney)|||Day 2 vs baseline||||>0.999
70896515|NCT04794803|141281561|SUPERIORITY|||||||0.05||||||p-values are referred to a two-sided Wilcoxon test for differences in the change of VAS scale.|Wilcoxon (Mann-Whitney)|||week 1 vs baseline||||0.050
70896516|NCT04794803|141281561|SUPERIORITY|||||||0.0227||||||p-values are referred to a two-sided Wilcoxon test for differences in the change of VAS scale.|Wilcoxon (Mann-Whitney)|||EOT vs baseline||||0.0227
70896517|NCT04794803|141281562|SUPERIORITY|||||||0.122|||||||Wilcoxon (Mann-Whitney)|||At Day 1||||0.122
70896518|NCT04794803|141281562|SUPERIORITY|||||||0.985|||||||Wilcoxon (Mann-Whitney)|||At Day 2||||0.985
70896519|NCT04794803|141281562|SUPERIORITY|||||||0.857|||||||Wilcoxon (Mann-Whitney)|||at week 1||||0.857
70896520|NCT04794803|141281562|SUPERIORITY|||||||0.436|||||||Wilcoxon (Mann-Whitney)|||at EOT||||0.436
70896521|NCT04794803|141281562|SUPERIORITY|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||At EOS||||0.350
70896522|NCT04794803|141281563|SUPERIORITY|p-values are referred to a two-sided Fisher's Exact test for worsening||||||0.596|||||||Fisher Exact|||Day 1||||0.596
70896523|NCT04794803|141281563|SUPERIORITY|p-values are referred to a two-sided Fisher's Exact test for worsening||||||0.667|||||||Fisher Exact|||Day 2||||0.667
70896524|NCT04794803|141281563|SUPERIORITY|p-values are referred to a two-sided Fisher's Exact test for worsening||||||0.037|||||||Fisher Exact|||Week 1||||0.037
70896525|NCT04794803|141281563|SUPERIORITY|p-values are referred to a two-sided Fisher's Exact test for worsening||||||0.293||||||p-values are referred to a two-sided Fisher's Exact test for worsening|Fisher Exact|||EOT||||0.293
70896526|NCT04794803|141281564|SUPERIORITY|||||||0.539||||||p-values are referred to a two-sided Fisher's Exact test for worsening and|Fisher Exact|||Day 1||||0.539
70896527|NCT04794803|141281564|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for worsening|Fisher Exact|||Day 2||||1.000
70896528|NCT04794803|141281564|SUPERIORITY|||||||0.102||||||p-values are referred to a two-sided Fisher's Exact test for worsening|Fisher Exact|||Week 1||||0.102
70896529|NCT04794803|141281564|SUPERIORITY|||||||0.119||||||p-values are referred to a two-sided Fisher's Exact test for worsening|Fisher Exact|||EOT||||0.119
70896530|NCT04794803|141281564|SUPERIORITY|||||||0.515||||||p-values are referred to a two-sided Fisher's Exact test for worsening|Fisher Exact|||EOS||||0.515
70896531|NCT04794803|141281565|SUPERIORITY|||||||0.366||||||p-values are referred to a two-sided Wilcoxon test for cumulative duration.|Wilcoxon (Mann-Whitney)|||Week 1||||0.366
70896532|NCT04794803|141281565|SUPERIORITY|||||||0.489||||||p-values are referred to a two-sided Wilcoxon test for cumulative duration.|Wilcoxon (Mann-Whitney)|||EOT||||0.489
70896533|NCT04794803|141281565|SUPERIORITY|||||||0.486||||||p-values are referred to a two-sided Wilcoxon test for cumulative duration.|Wilcoxon (Mann-Whitney)|||EOS||||0.486
70896534|NCT04794803|141281566|SUPERIORITY|||||||0.79||||||p-values are referred to a two-sided Wilcoxon test for cumulative quantity|Wilcoxon (Mann-Whitney)|||Week 1||||0.790
70896535|NCT04794803|141281566|SUPERIORITY|||||||0.961||||||p-values are referred to a two-sided Wilcoxon test for cumulative quantity|Wilcoxon (Mann-Whitney)|||EOT||||0.961
70896536|NCT04794803|141281566|SUPERIORITY|||||||0.619||||||p-values are referred to a two-sided Wilcoxon test for cumulative quantity|Wilcoxon (Mann-Whitney)|||EOS||||0.619
70896537|NCT04794803|141281567|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||Baseline||||1.000
70896538|NCT04794803|141281567|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||Day 1||||1.000
70896539|NCT04794803|141281567|SUPERIORITY|||||||0.678||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||Day 2||||0.678
70896540|NCT04794803|141281567|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||Week 1||||1.000
70896541|NCT04794803|141281567|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||EOT||||1.000
70896542|NCT04794803|141281567|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||EOS||||1.000
70896543|NCT04794803|141281568|SUPERIORITY|||||||0.696||||||p-values are referred to a two-sided Wilcoxon test for cumulative duration|Wilcoxon (Mann-Whitney)|||Week 1||||0.696
70896544|NCT04794803|141281568|SUPERIORITY||||||>|0.999||||||p-values are referred to a-sided Wilcoxon test for cumulative duration|Wilcoxon (Mann-Whitney)|||EOT||||>0.999
70896545|NCT04794803|141281568|SUPERIORITY|||||||0.596||||||p-values are referred to a-sided Wilcoxon test for cumulative duration|Wilcoxon (Mann-Whitney)|||EOS||||0.596
70896546|NCT04794803|141281569|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||Baseline||||1.000
70896547|NCT04794803|141281569|SUPERIORITY|||||||1|||||||Fisher Exact|p-values are referred to a two-sided Fisher's Exact test for proportion||Day 1||||1.000
70896548|NCT04794803|141281569|SUPERIORITY|||||||1|||||||Fisher Exact|p-values are referred to a two-sided Fisher's Exact test for proportion||Day 2||||1.000
70896549|NCT04794803|141281569|SUPERIORITY|||||||1|||||||Fisher Exact|p-values are referred to a two-sided Fisher's Exact test for proportion||week 1||||1.000
70896550|NCT04794803|141281569|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||EOT||||1.000
70896551|NCT04794803|141281571|SUPERIORITY|||||||0.76||||||p-values are referred to a two-sided Wilcoxon test|Wilcoxon (Mann-Whitney)|||baseline||||0.760
70896552|NCT04794803|141281571|SUPERIORITY|||||||0.394||||||p-values are referred to a two-sided Wilcoxon test|Wilcoxon (Mann-Whitney)|||Week 1||||0.394
70896553|NCT04794803|141281571|SUPERIORITY|||||||0.141||||||p-values are referred to a two-sided Wilcoxon test|Wilcoxon (Mann-Whitney)|||EOT||||0.141
70896554|NCT04794803|141281571|SUPERIORITY||||||>|0.999||||||p-values are referred to a two-sided Wilcoxon test|Wilcoxon (Mann-Whitney)|||EOS||||>0.999
70896555|NCT04794803|141281572|SUPERIORITY|||||||0.5||||||p-values are referred to a two-sided Wilcoxon test.|Wilcoxon (Mann-Whitney)|||baseline||||0.500
70896556|NCT04794803|141281572|SUPERIORITY|||||||0.112||||||p-values are referred to a two-sided Wilcoxon test.|Wilcoxon (Mann-Whitney)|||week 1||||0.112
70896557|NCT04794803|141281572|SUPERIORITY|||||||0.277||||||p-values are referred to a two-sided Wilcoxon test.|Wilcoxon (Mann-Whitney)|||EOT||||0.277
70896558|NCT04794803|141281572|SUPERIORITY||||||>|0.999||||||p-values are referred to a two-sided Wilcoxon test.|Wilcoxon (Mann-Whitney)|||EOS||||>0.999
70896559|NCT04794803|141281573|SUPERIORITY|||||||0.2027||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||Day 1 vs baseline||||0.2027
70896560|NCT04794803|141281573|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||Day 2 vs baseline||||1.0000
70896561|NCT04794803|141281573|SUPERIORITY|||||||0.4469||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||Week 1 vs baseline||||0.4469
70896562|NCT04794803|141281573|SUPERIORITY|||||||0.2466||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||EOT vs baseline||||0.2466
70896563|NCT04794803|141281573|SUPERIORITY|||||||0.1752||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||EOS vs baseline||||0.1752
70896564|NCT04794803|141281574|SUPERIORITY|||||||0.6441||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||Day 1 vs baseline||||0.6441
70896565|NCT04794803|141281574|SUPERIORITY|||||||0.3529||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||Day 2 vs baseline||||0.3529
70896566|NCT04794803|141281574|SUPERIORITY|||||||0.3581||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||week 1 vs baseline||||0.3581
70896567|NCT04794803|141281574|SUPERIORITY|||||||0.1666||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||EOT vs baseline||||0.1666
70896568|NCT04794803|141281574|SUPERIORITY|||||||0.0851||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||EOS vs baseline||||0.0851
70896569|NCT04794803|141281575|SUPERIORITY|||||||0.3359||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||Day 1 vs baseline||||0.3359
70896570|NCT04794803|141281575|SUPERIORITY|||||||0.3136||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||Day 2 vs baseline||||0.3136
70896571|NCT04794803|141281575|SUPERIORITY|||||||0.0441||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||week 1 vs baseline||||0.0441
70896572|NCT04794803|141281575|SUPERIORITY|||||||0.0965||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||EOT vs baseline||||0.0965
70896573|NCT04794803|141281575|SUPERIORITY|||||||0.0519||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||EOS vs baseline||||0.0519
70896574|NCT04794803|141281576|SUPERIORITY|||||||0.47||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||Day 1 vs baseline||||0.470
70896575|NCT04794803|141281576|SUPERIORITY|||||||0.425||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||Day 2 vs baseline||||0.425
70896576|NCT04794803|141281576|SUPERIORITY|||||||0.086||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||week 1 vs baseline||||0.086
70896577|NCT04794803|141281576|SUPERIORITY|||||||0.6||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||EOT vs baseline||||0.600
70896578|NCT04794803|141281576|SUPERIORITY|||||||0.717||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||EOS vs baseline||||0.717
70896579|NCT03624504|141281596|OTHER|Assume expected performance to be 94%. The Objective Performance Criterion (OPC) is set at 83% (same performance threshold in FDA approved global study). Assumes 0.05 significance level, 2-sided, 80% power and 10% study attrition.|Kaplan-Meier survival probability (%)|97.6||||0.0021|TWO_SIDED|95.0|90.6|99.4||The threshold for significance was 0.05.|z test, 1-sided||The major complication free rate (i.e. survival probability) was estimated using the Kaplan-Meier method.|"Null hypothesis: Major complication free rate at 6 months post-implant is less than or equal to 83%~Alternative hypothesis: Major complication free rate at 6 months post-implant is greater than 83%."||99.4|90.6|0.0021
70896580|NCT00951483|141281619|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-2.65||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that C-reactive protein (CRP) is no different between the experimental and healthy control cohorts at 12 weeks.||||.001
70896581|NCT00951483|141281620|SUPERIORITY_OR_OTHER||z-score|-4.544|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline HAM-D-7 score and end of treatment (i.e., 12 week) HAM-D-7 score.||||<.001
70896582|NCT00951483|141281621|SUPERIORITY_OR_OTHER||z-score|-4.627|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline HAMD-17 score and end of treatment (i.e., 12 week) HAMD-17 score.||||<.001
70896583|NCT00951483|141281622|SUPERIORITY_OR_OTHER||z-score|-4.624|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline HAMD-21 score and end of treatment (i.e., 12 week) HAMD-21 score.||||<.001
70896584|NCT00951483|141281623|SUPERIORITY_OR_OTHER||z-score|-4.51|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline HAM-A score and end of treatment (i.e., 12 week) HAM-A score.||||<.001
70896585|NCT00951483|141281624|SUPERIORITY_OR_OTHER||z-score|-4.435|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline BDI score and end of treatment (i.e., 12 week) BDI score.||||<.001
70896586|NCT00951483|141281625|SUPERIORITY_OR_OTHER||z-score|-3.911|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline PSS-14 score and end of treatment (i.e., 12 week) PSS-14 score.||||<.001
70896587|NCT03015402|141281626|SUPERIORITY|Pre-randomization characteristics of 2 groups will be presented using the median (IQR) or frequency tables at each study sequence. The difference of mPAP during submax exercise compared between placebo and nitrite at 10 weeks (i.e. week 10 RHC of placebo vs week 10 RHC of nitrite) using parametric PK-cross analysis (i.e. ANOVA to determine the sequence, period, carryover, \& treatment effects). Post-exercise values before \& after crossover will be compared between 2 groups using similar approach.||||||0.2|||||||ANOVA|||||||0.20
70896588|NCT01995461|141281645|SUPERIORITY_OR_OTHER|||||||0.0252|TWO_SIDED||||||t-test, 2 sided|paired t-test||||||0.0252
70896589|NCT01995461|141281646|SUPERIORITY_OR_OTHER|||||||0.0154|TWO_SIDED||||||t-test, 2 sided|paired t-test||||||0.0154
70896590|NCT01995461|141281647|SUPERIORITY_OR_OTHER|||||||0.1349|TWO_SIDED||||||t-test, 2 sided|paired t-test||||||0.1349
70896591|NCT00540124|141281667|SUPERIORITY_OR_OTHER|||||||0.073||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.073
70896592|NCT00540124|141281667|SUPERIORITY_OR_OTHER|||||||0.186||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.186
70896593|NCT00540124|141281668|SUPERIORITY_OR_OTHER|||||||0.155||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.155
70896594|NCT00540124|141281668|SUPERIORITY_OR_OTHER|||||||0.155||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.155
70896595|NCT00540124|141281668|SUPERIORITY_OR_OTHER|||||||0.108||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.108
70896596|NCT00540124|141281668|SUPERIORITY_OR_OTHER|||||||0.112||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.112
70896597|NCT00540124|141281669|SUPERIORITY_OR_OTHER|||||||0.137||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.137
70896598|NCT00540124|141281669|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.009
70896599|NCT00540124|141281669|SUPERIORITY_OR_OTHER|||||||0.118||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.118
70896600|NCT00540124|141281669|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.018
70896601|NCT00540124|141281669|SUPERIORITY_OR_OTHER|||||||0.207||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.207
70896602|NCT00540124|141281669|SUPERIORITY_OR_OTHER|||||||0.581||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.581
70896603|NCT00540124|141281670|SUPERIORITY_OR_OTHER|||||||0.306||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.306
70896604|NCT00540124|141281670|SUPERIORITY_OR_OTHER|||||||0.762||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.762
70896605|NCT00540124|141281670|SUPERIORITY_OR_OTHER|||||||0.203||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.203
70896606|NCT00540124|141281670|SUPERIORITY_OR_OTHER|||||||0.464||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.464
70896607|NCT00540124|141281670|SUPERIORITY_OR_OTHER|||||||0.169||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.169
70896608|NCT00540124|141281670|SUPERIORITY_OR_OTHER|||||||0.243||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.243
70896609|NCT00540124|141281671|SUPERIORITY_OR_OTHER|||||||0.206||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.206
70896610|NCT00540124|141281671|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.457
70896611|NCT00540124|141281671|SUPERIORITY_OR_OTHER|||||||0.892||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.892
70896612|NCT00540124|141281671|SUPERIORITY_OR_OTHER|||||||0.593||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.593
70896613|NCT00540124|141281671|SUPERIORITY_OR_OTHER|||||||0.887||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.887
70896614|NCT00540124|141281671|SUPERIORITY_OR_OTHER|||||||0.762||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.762
70896615|NCT00540124|141281672|SUPERIORITY_OR_OTHER|||||||0.691||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.691
70896616|NCT00540124|141281672|SUPERIORITY_OR_OTHER|||||||0.415||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.415
70896617|NCT00540124|141281673|SUPERIORITY_OR_OTHER|||||||0.176||95.0||||P-value based on Cochran-Mantel-Haenszel Test with modified ridit scores controlling for alpha block use (yes/no) and lower urinary tract symptom severity as stratification factors.|Cochran-Mantel-Haenszel|||||||0.176
70896618|NCT00540124|141281673|SUPERIORITY_OR_OTHER|||||||0.921||95.0||||P-value based on Cochran-Mantel-Haenszel Test with modified ridit scores controlling for alpha block use (yes/no) and lower urinary tract symptom severity as stratification factors.|Cochran-Mantel-Haenszel|||||||0.921
70896619|NCT00540124|141281674|SUPERIORITY_OR_OTHER|||||||0.429||95.0||||P-value based on Cochran-Mantel-Haenszel Test with modified ridit scores controlling for alpha block use (yes/no) and lower urinary tract symptom severity as stratification factors.|Cochran-Mantel-Haenszel|||||||0.429
70896620|NCT00540124|141281674|SUPERIORITY_OR_OTHER|||||||0.304||95.0||||P-value based on Cochran-Mantel-Haenszel Test with modified ridit scores controlling for alpha block use (yes/no) and lower urinary tract symptom severity as stratification factors.|Cochran-Mantel-Haenszel|||||||0.304
70896621|NCT00540124|141281675|SUPERIORITY_OR_OTHER|||||||0.254||95.0||||P-value for 12 Week Change Waking Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.254
70896622|NCT00540124|141281675|SUPERIORITY_OR_OTHER|||||||0.359||95.0||||P-value for 12 Week Change Waking Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.359
70896623|NCT00540124|141281675|SUPERIORITY_OR_OTHER|||||||0.098||95.0||||P-value for 12 Week Change Sleeping Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.098
70896624|NCT00540124|141281675|SUPERIORITY_OR_OTHER|||||||0.632||95.0||||P-value for 12 Week Change Sleeping Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.632
70896625|NCT00540124|141281675|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||P-value for 12 Week Change Total Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.102
70896626|NCT00540124|141281675|SUPERIORITY_OR_OTHER|||||||0.348||95.0||||P-value for 12 Week Change Total Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.348
70896627|NCT00540124|141281676|SUPERIORITY_OR_OTHER|||||||0.208||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.208
70896628|NCT00540124|141281676|SUPERIORITY_OR_OTHER|||||||0.985||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.985
70896629|NCT00540124|141281677|SUPERIORITY_OR_OTHER|||||||0.385||95.0||||P-value for 12 Week Change Terminal Micturation Dribble. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.385
70896630|NCT00540124|141281677|SUPERIORITY_OR_OTHER|||||||0.595||95.0||||P-value for 12 Week Change Terminal Micturation Dribble. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.595
70896631|NCT00540124|141281677|SUPERIORITY_OR_OTHER|||||||0.704||95.0||||P-value for 12 Week Change Post Micturation Dribble. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.704
70896632|NCT00540124|141281677|SUPERIORITY_OR_OTHER|||||||0.439||95.0||||P-value for 12 Week Change Post Micturation Dribble. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.439
70896633|NCT00540124|141281678|SUPERIORITY_OR_OTHER|||||||0.838||95.0||||P-value for 12 Week Change Qmax. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.838
70896634|NCT00540124|141281678|SUPERIORITY_OR_OTHER|||||||0.831||95.0||||P-value for 12 Week Change Qmax. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.831
70896635|NCT00540124|141281678|SUPERIORITY_OR_OTHER|||||||0.696||95.0||||P-value for 12 Week Change Qmean. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.696
70896636|NCT00540124|141281678|SUPERIORITY_OR_OTHER|||||||0.257||95.0||||P-value for 12 Week Change Qmean. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.257
70896637|NCT00540124|141281679|SUPERIORITY_OR_OTHER|||||||0.709||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.709
70896638|NCT00540124|141281679|SUPERIORITY_OR_OTHER|||||||0.494||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.494
70896639|NCT02300220|141281696|SUPERIORITY||Cox Proportional Hazard|1.071||||0.764|TWO_SIDED|95.0|0.684|1.676|||Regression, Cox|||The primary endpoint was assessed using a Cox's proportional hazard model with pre-specified adjustment for patient's self-reported history of exacerbations over the previous year and with stratification for study centre. The onset of exacerbation will be monitored up to 90 days or at patient withdrawal.||1.676|0.684|0.764
70896640|NCT02300220|141281697|SUPERIORITY|||||||0.703|||||||Wilcoxon (Mann-Whitney)|||||||0.703
70896641|NCT02300220|141281699|SUPERIORITY|||||||0.239|||||||t-test, 2 sided|||||||0.239
70896642|NCT04322682|141281702|SUPERIORITY||Odds Ratio (OR)|0.79||||0.081|TWO_SIDED|95.1|0.61|1.03|||Chi-squared|||||1.03|0.61|0.081
70896643|NCT04322682|141281703|SUPERIORITY||Odds Ratio (OR)|0.56||||0.291|TWO_SIDED|95.0|0.19|1.67|||Chi-squared|||||1.67|0.19|0.291
70896644|NCT04322682|141281704|SUPERIORITY||Odds Ratio (OR)|0.79||||0.077|TWO_SIDED|95.0|0.6|1.03|||Chi-squared|||||1.03|0.60|0.077
70896645|NCT04322682|141281705|SUPERIORITY||Odds Ratio (OR)|0.53||||0.08|TWO_SIDED|95.0|0.25|1.09|||Chi-squared|||||1.09|0.25|0.080
70896646|NCT04322682|141281706|SUPERIORITY||Odds Ratio (OR)|0.75||||0.042|TWO_SIDED|95.0|0.57|0.99||P-Value is for the comparison of the treatment group within patients with Covid-19 confirmed by PCR.|Regression, Logistic|Logistic-regression model including the treatment group, the PCR-confirmed Covid-19 subgroup factor (yes/no) and their interaction was performed.||||0.99|0.57|0.042
70896647|NCT02238379|141281710|SUPERIORITY_OR_OTHER|||||||0.003||||||Main Effect of Emotion|ANOVA|Spray (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) by Hemisphere (Left, Right) ANOVA||N170 Analysis||||.003
70896648|NCT02238379|141281710|SUPERIORITY_OR_OTHER|||||||0.034||||||Main Effect of Face Type|ANOVA|Spray (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) by Hemisphere (Left, Right) ANOVA||N170 Analysis||||.034
70896649|NCT02238379|141281710|SUPERIORITY_OR_OTHER|||||||0.03||||||Main Effect of Face Type|ANOVA|Spray Type (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) ANOVA||P300 Analysis||||.03
70896650|NCT02238379|141281710|SUPERIORITY_OR_OTHER|||||||0.03||||||Spray Type by Face Type Interaction|ANOVA|Spray Type (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) ANOVA||P300 Analysis||||.03
70896651|NCT02238379|141281710|SUPERIORITY_OR_OTHER||||||>|0.22||||||No Main Effects or Interactions|ANOVA|Spray Type (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) ANOVA||LPP Analysis||||>.22
70896652|NCT02238379|141281711|SUPERIORITY_OR_OTHER||||||>|0.14||||||No Main Effects or Interactions|ANOVA|Spray Type (Oxytocin, Placebo) and Hemisphere (left, right) ANOVA||N170 Analysis||||>.14
70896653|NCT02238379|141281711|SUPERIORITY_OR_OTHER||||||>|0.17||||||No difference between Spray Types|t-test, 2 sided|Paired samples t-test comparing Spray Type (Oxytocin vs Placebo)||P300 Analysis||||>.17
70896654|NCT02238379|141281711|SUPERIORITY_OR_OTHER||||||>|0.27||||||No difference between Spray Types|t-test, 2 sided|Paired samples t-test comparing Spray Type (Oxytocin vs Placebo)||LPP Analysis||||>.27
70896655|NCT02238379|141281712|SUPERIORITY_OR_OTHER|||||||0.006||||||Main Effect of Emotion|ANOVA|Spray Type (Oxytocin, Placebo), Face Type (Infant, Adult), Emotion (Neutral, Distressed), and Hemisphere (left, right) ANOVA||Only relevant for N170||||.006
70896656|NCT02238379|141281712|SUPERIORITY_OR_OTHER|||||||0.01||||||Main Effect of Hemisphere|ANOVA|Spray Type (Oxytocin, Placebo), Face Type (Infant, Adult), Emotion (Neutral, Distressed), and Hemisphere (left, right) ANOVA||Only relevant for N170||||.01
70896657|NCT02238379|141281713|SUPERIORITY_OR_OTHER|||||||0.03||||||Main Effect of Spray|ANOVA|Spray (oxytocin, placebo) by Hemisphere (left, right) ANOVA||Only relevant for N170||||.03
70896658|NCT02238379|141281713|SUPERIORITY_OR_OTHER|||||||0.008||||||Main Effect of Hemisphere|ANOVA|Spray (oxytocin, placebo) by Hemisphere (left, right) ANOVA||Only relevant for N170||||.008
70896659|NCT02238379|141281714|SUPERIORITY_OR_OTHER|||||||0.05|||||||correlation|||||||.05
70896660|NCT02238379|141281716|SUPERIORITY_OR_OTHER|||||||0.05|||||||correlation|||||||.05
70896661|NCT02238379|141281717|SUPERIORITY_OR_OTHER|||||||0.05|||||||correlation|||||||.05
70896662|NCT02238379|141281718|SUPERIORITY_OR_OTHER|||||||0.05|||||||correlation|||||||.05
70896663|NCT00605280|141281745|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38||||0.0047|TWO_SIDED|95.0|1.32|4.3||Adjusted for glycolated hemoglobin (HbA1c), systolic blood pressure (BP), diastolic BP, and baseline VA. Baseline values not carried forward for missing post-baseline data.|Cochran-Mantel-Haenszel|||||4.30|1.32|0.0047
70896664|NCT00605280|141281746|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.1904|TWO_SIDED|95.0|0.85|2.53|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||2.53|0.85|0.1904
70896665|NCT00605280|141281747|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57||||0.2466|TWO_SIDED|95.0|0.74|3.34|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||3.34|0.74|0.2466
70896666|NCT00605280|141281748|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.1388|TWO_SIDED|95.0|0.86|3.26|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||3.26|0.86|0.1388
70896667|NCT00605280|141281749|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||0.0468|TWO_SIDED|95.0|0.07|0.99|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||0.99|0.07|0.0468
70896668|NCT00605280|141281750|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9||||0.1124|TWO_SIDED|95.0|0.73|11.55|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||11.55|0.73|0.1124
70896669|NCT00605280|141281751|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48||||0.1788|TWO_SIDED|95.0|0.16|1.42|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||1.42|0.16|0.1788
70896670|NCT00605280|141281752|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.12||||0.0048|TWO_SIDED|95.0|1.45|18.06|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||18.06|1.45|0.0048
70896671|NCT00605280|141281753|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean|3.9||||0.004|TWO_SIDED|95.0|1.25|6.54|||ANCOVA|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||6.54|1.25|0.0040
70896672|NCT00605280|141281754|SUPERIORITY_OR_OTHER||LS Mean|4.57||||0.0011|TWO_SIDED|95.0|1.85|7.29|||ANCOVA|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post baseline data.||||7.29|1.85|0.0011
70896673|NCT00605280|141281755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42||||0.0023|TWO_SIDED|95.0|0.24|0.74|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||0.74|0.24|0.0023
70896674|NCT00605280|141281756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.0008|TWO_SIDED|95.0|0.23|0.69|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||0.69|0.23|0.0008
70896675|NCT00205348|141281827|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Burden was tested with the Wilcoxon signed-rank test.||||0.0007
70896676|NCT00205348|141281827|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Physical was tested with the Wilcoxon signed-rank test.||||<0.0001
70896677|NCT00205348|141281827|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Mental was tested with the Wilcoxon signed-rank test.||||0.0002
70896678|NCT00205348|141281827|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Fear was tested with the Wilcoxon signed-rank test.||||<0.0001
70896679|NCT00205348|141281827|SUPERIORITY_OR_OTHER|||||||0.0973|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Eating Desire was tested with the Wilcoxon signed-rank test.||||0.0973
70896680|NCT00205348|141281827|SUPERIORITY_OR_OTHER|||||||0.1772|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Eating Duration was tested with the Wilcoxon signed-rank test.||||0.1772
70896681|NCT00205348|141281827|SUPERIORITY_OR_OTHER|||||||0.0062|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Food Selection was tested with the Wilcoxon signed-rank test.||||0.0062
70896682|NCT00205348|141281827|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Sleep was tested with the Wilcoxon signed-rank test.||||<0.0001
70896683|NCT00205348|141281827|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Fatigue was tested with the Wilcoxon signed-rank test.||||0.0002
70896684|NCT00205348|141281827|SUPERIORITY_OR_OTHER|||||||0.2125|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Social was tested with the Wilcoxon signed-rank test.||||0.2125
70896685|NCT00205348|141281827|SUPERIORITY_OR_OTHER|||||||0.0332|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Communication was tested with the Wilcoxon signed-rank test.||||0.0332
70896686|NCT00374322|141281828|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.286|TWO_SIDED|95.0|0.77|1.08||The p-value was calculated from a stratified log-rank test, stratifying for hormone receptor status, time since initial diagnosis, and lymph node involvement.|Log Rank||Estimate of the treatment hazard ratio (HR) was calcuated using the pike estimator.|||1.08|0.77|0.286
70896687|NCT03969719|141281844|EQUIVALENCE|The comparisons of PF-06835919 to placebo was performed at a Type I error rate of 10%.|Mean Difference (Final Values)|-12.44||||0.0696|TWO_SIDED|90.0|-22.37|-1.25|||ANCOVA|||||-1.25|-22.37|0.0696
70896688|NCT03969719|141281844|EQUIVALENCE|The comparisons of PF-06835919 to placebo was performed at a Type I error rate of 10%.|Mean Difference (Final Values)|-14.64||||0.0288|TWO_SIDED|90.0|-24.18|-3.89|||ANCOVA|||||-3.89|-24.18|0.0288
70896689|NCT03969719|141281845|EQUIVALENCE|The comparisons of PF-06835919 to placebo was performed at a Type I error rate of 10%.|Mean Difference (Final Values)|-0.08||||0.6336|TWO_SIDED|90.0|-0.36|0.2|||Mixed Models Analysis|||||0.20|-0.36|0.6336
70896690|NCT03969719|141281845|EQUIVALENCE|The comparisons of PF-06835919 to placebo was performed at a Type I error rate of 10%.|Mean Difference (Final Values)|-0.25||||0.1266|TWO_SIDED|90.0|-0.52|0.02|||Mixed Models Analysis|||||0.02|-0.52|0.1266
70896691|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.06||0.87|TWO_SIDED|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.18|-0.05|0.87
70896692|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.06||0.78|TWO_SIDED|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.18|-0.05|0.78
70896693|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.06||0.67|TWO_SIDED|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.18|-0.05|0.67
70896694|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.06||0.52|TWO_SIDED|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.18|-0.05|0.52
70896695|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.06||0.39|TWO_SIDED|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.18|-0.05|0.39
70896696|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.06||0.26|TWO_SIDED|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.18|-0.05|0.26
70896697|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.04|STANDARD_DEVIATION|0.07||0.31|TWO_SIDED|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.09|-0.20|0.31
70896698|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.04|STANDARD_DEVIATION|0.07||0.22|TWO_SIDED|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.09|-0.20|0.22
70896699|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.04|STANDARD_DEVIATION|0.07||0.14|TWO_SIDED|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.09|-0.20|0.14
70896700|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.04|STANDARD_DEVIATION|0.07||0.09|TWO_SIDED|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.09|-0.20|0.09
70896701|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.04|STANDARD_DEVIATION|0.07||0.05|TWO_SIDED|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.09|-0.20|0.05
70896702|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.04|STANDARD_DEVIATION|0.07||0.03|TWO_SIDED|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.09|-0.20|0.03
70896703|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.08|STANDARD_DEVIATION|0.08||0.85|TWO_SIDED|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.23|-0.06|0.85
70896704|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.08|STANDARD_DEVIATION|0.08||0.79|TWO_SIDED|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.23|-0.06|0.79
70896705|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.08|STANDARD_DEVIATION|0.08||0.71|TWO_SIDED|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.23|-0.06|0.71
70896706|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.08|STANDARD_DEVIATION|0.08||0.61|TWO_SIDED|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.23|-0.06|0.61
70896707|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.08|STANDARD_DEVIATION|0.08||0.51|TWO_SIDED|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.23|-0.06|0.51
70896708|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.08|STANDARD_DEVIATION|0.08||0.41|TWO_SIDED|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.23|-0.06|0.41
70896709|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.0|STANDARD_DEVIATION|0.07||0.47|TWO_SIDED|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.14|-0.16|0.47
70896710|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.0|STANDARD_DEVIATION|0.07||0.36|TWO_SIDED|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.14|-0.16|0.36
70896711|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.0|STANDARD_DEVIATION|0.07||0.26|TWO_SIDED|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.14|-0.16|0.26
70896712|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.0|STANDARD_DEVIATION|0.07||0.19|TWO_SIDED|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.14|-0.16|0.19
70896713|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.0|STANDARD_DEVIATION|0.07||0.13|TWO_SIDED|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.14|-0.16|0.13
70896714|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.0|STANDARD_DEVIATION|0.07||0.09|TWO_SIDED|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.14|-0.16|0.09
70896715|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.08||0.78|TWO_SIDED|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.11|0.78
70896716|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.08||0.69|TWO_SIDED|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.11|0.69
70896717|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.08||0.59|TWO_SIDED|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.11|0.59
70896718|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.08||0.5|TWO_SIDED|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.11|0.50
70896719|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.08||0.39|TWO_SIDED|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.11|0.39
70896720|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.08||0.3|TWO_SIDED|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.11|0.30
70896721|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.04|STANDARD_DEVIATION|0.08||0.68|TWO_SIDED|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.14|0.68
70896722|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.04|STANDARD_DEVIATION|0.08||0.59|TWO_SIDED|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.14|0.59
70896723|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.04|STANDARD_DEVIATION|0.08||0.5|TWO_SIDED|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.14|0.50
70896724|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.04|STANDARD_DEVIATION|0.08||0.4|TWO_SIDED|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.14|0.40
70896725|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.04|STANDARD_DEVIATION|0.08||0.3|TWO_SIDED|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.14|0.30
70896726|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.04|STANDARD_DEVIATION|0.08||0.22|TWO_SIDED|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.14|0.22
70896727|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.08||0.41|TWO_SIDED|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.13|-0.19|0.41
70896728|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.08||0.32|TWO_SIDED|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.13|-0.19|0.32
70896729|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.08||0.24|TWO_SIDED|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.13|-0.19|0.24
70896730|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.08||0.16|TWO_SIDED|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.13|-0.19|0.16
70896731|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.08||0.11|TWO_SIDED|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.13|-0.19|0.11
70896732|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.08||0.07|TWO_SIDED|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.13|-0.19|0.07
70896733|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.09||0.41|TWO_SIDED|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.15|-0.20|0.41
70896734|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.09||0.32|TWO_SIDED|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.15|-0.20|0.32
70896735|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.09||0.25|TWO_SIDED|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.15|-0.20|0.25
70896736|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.09||0.18|TWO_SIDED|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.15|-0.20|0.18
70896737|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.09||0.12|TWO_SIDED|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.15|-0.20|0.12
70896738|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.09||0.07|TWO_SIDED|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.15|-0.20|0.07
70896739|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.01|STANDARD_DEVIATION|0.1||0.45|TWO_SIDED|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.17|-0.20|0.45
70896740|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.01|STANDARD_DEVIATION|0.1||0.37|TWO_SIDED|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.17|-0.20|0.37
70896741|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.01|STANDARD_DEVIATION|0.1||0.3|TWO_SIDED|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.17|-0.20|0.30
70896742|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.01|STANDARD_DEVIATION|0.1||0.22|TWO_SIDED|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.17|-0.20|0.22
70896743|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.01|STANDARD_DEVIATION|0.1||0.17|TWO_SIDED|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.17|-0.20|0.17
70896744|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.01|STANDARD_DEVIATION|0.1||0.12|TWO_SIDED|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.17|-0.20|0.12
70896745|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.09||0.72|TWO_SIDED|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.24|-0.13|0.72
70896746|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.09||0.65|TWO_SIDED|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.24|-0.13|0.65
70896747|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.09||0.57|TWO_SIDED|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.24|-0.13|0.57
70896748|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.09||0.48|TWO_SIDED|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.24|-0.13|0.48
70896749|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.09||0.39|TWO_SIDED|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.24|-0.13|0.39
70896750|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.09||0.3|TWO_SIDED|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.24|-0.13|0.30
70896751|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.09|STANDARD_DEVIATION|0.12||0.76|TWO_SIDED|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.32|-0.15|0.76
70896752|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.09|STANDARD_DEVIATION|0.12||0.71|TWO_SIDED|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.32|-0.15|0.71
70896753|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.09|STANDARD_DEVIATION|0.12||0.65|TWO_SIDED|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.32|-0.15|0.65
70896754|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.09|STANDARD_DEVIATION|0.12||0.59|TWO_SIDED|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.32|-0.15|0.59
70896755|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.09|STANDARD_DEVIATION|0.12||0.53|TWO_SIDED|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.32|-0.15|0.53
70896756|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.09|STANDARD_DEVIATION|0.12||0.46|TWO_SIDED|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.32|-0.15|0.46
70896757|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.11||0.68|TWO_SIDED|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.28|-0.15|0.68
70896758|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.11||0.61|TWO_SIDED|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.28|-0.15|0.61
70896759|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.11||0.55|TWO_SIDED|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.28|-0.15|0.55
70896760|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.11||0.46|TWO_SIDED|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.28|-0.15|0.46
70896761|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.11||0.4|TWO_SIDED|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.28|-0.15|0.40
70896762|NCT02130193|141281877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.11||0.33|TWO_SIDED|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.28|-0.15|0.33
70896763|NCT02130193|141281881|SUPERIORITY_OR_OTHER||Posterior mean difference|2.48|STANDARD_DEVIATION|0.977||0.013|TWO_SIDED|95.0|0.92|4.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 1.0 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||4.43|0.92|0.013
70896764|NCT02130193|141281881|SUPERIORITY_OR_OTHER||Posterior mean difference|2.48|STANDARD_DEVIATION|0.977||0.006|TWO_SIDED|95.0|0.92|4.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.9 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||4.43|0.92|0.006
70896765|NCT02130193|141281881|SUPERIORITY_OR_OTHER||Posterior mean difference|2.48|STANDARD_DEVIATION|0.977||0.003|TWO_SIDED|95.0|0.92|4.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.8 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||4.43|0.92|0.003
70896766|NCT02130193|141281881|SUPERIORITY_OR_OTHER||Posterior mean difference|2.48|STANDARD_DEVIATION|0.977||0.001|TWO_SIDED|95.0|0.92|4.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.7 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||4.43|0.92|0.001
70896767|NCT02130193|141281881|SUPERIORITY_OR_OTHER||Posterior mean difference|2.48|STANDARD_DEVIATION|0.977|<|0.001|TWO_SIDED|95.0|0.92|4.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.6 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||4.43|0.92|<0.001
70896768|NCT02130193|141281882|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|1.29||0.6|TWO_SIDED|95.0|-2.81|2.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 1 month. Data presented are for 95% equal-tailed credible intervals|||2.17|-2.81|0.60
70896769|NCT02130193|141281882|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.58|STANDARD_DEVIATION|1.42||0.65|TWO_SIDED|95.0|-3.11|2.37||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 2 month. Data presented are for 95% equal-tailed credible intervals|||2.37|-3.11|0.65
70896770|NCT02130193|141281882|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.46|STANDARD_DEVIATION|1.52||0.83|TWO_SIDED|95.0|-4.43|1.45||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 3 month. Data presented are for 95% equal-tailed credible intervals|||1.45|-4.43|0.83
70896771|NCT02130193|141281882|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.2|STANDARD_DEVIATION|1.53||0.78|TWO_SIDED|95.0|-4.07|1.9||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 4 month. Data presented are for 95% equal-tailed credible intervals|||1.90|-4.07|0.78
70896772|NCT02130193|141281882|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.96|STANDARD_DEVIATION|1.56||0.73|TWO_SIDED|95.0|-3.82|2.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 5 month. Data presented are for 95% equal-tailed credible intervals|||2.28|-3.82|0.73
70896773|NCT02130193|141281882|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.93|STANDARD_DEVIATION|1.58||0.72|TWO_SIDED|95.0|-4.01|2.26||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 6 month. Data presented are for 95% equal-tailed credible intervals|||2.26|-4.01|0.72
70896774|NCT02130193|141281882|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.0|STANDARD_DEVIATION|1.58||0.73|TWO_SIDED|95.0|-4.15|2.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 7 month. Data presented are for 95% equal-tailed credible intervals|||2.09|-4.15|0.73
70896775|NCT02130193|141281882|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.48|STANDARD_DEVIATION|1.69||0.81|TWO_SIDED|95.0|-4.71|1.76||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 8 month. Data presented are for 95% equal-tailed credible intervals|||1.76|-4.71|0.81
70896776|NCT02130193|141281882|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.23|STANDARD_DEVIATION|1.75||0.76|TWO_SIDED|95.0|-4.66|2.22||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 9 month. Data presented are for 95% equal-tailed credible intervals|||2.22|-4.66|0.76
70896777|NCT02130193|141281882|SUPERIORITY_OR_OTHER||Posterior mean difference|-2.26|STANDARD_DEVIATION|1.74||0.91|TWO_SIDED|95.0|-5.66|0.99||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.99|-5.66|0.91
70896778|NCT02130193|141281882|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.05|STANDARD_DEVIATION|1.73||0.71|TWO_SIDED|95.0|-4.73|2.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 11 month. Data presented are for 95% equal-tailed credible intervals|||2.13|-4.73|0.71
70896779|NCT02130193|141281882|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.35|STANDARD_DEVIATION|1.74||0.78|TWO_SIDED|95.0|-4.77|2.04||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 12 month. Data presented are for 95% equal-tailed credible intervals|||2.04|-4.77|0.78
70896780|NCT02130193|141281886|SUPERIORITY_OR_OTHER||Posterior mean difference|1.15|STANDARD_DEVIATION|0.242||0.278|TWO_SIDED|95.0|0.71|1.63||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 1.0 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.63|0.71|0.278
70896781|NCT02130193|141281886|SUPERIORITY_OR_OTHER||Posterior mean difference|1.15|STANDARD_DEVIATION|0.242||0.138|TWO_SIDED|95.0|0.71|1.63||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.9 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.63|0.71|0.138
70896782|NCT02130193|141281886|SUPERIORITY_OR_OTHER||Posterior mean difference|1.15|STANDARD_DEVIATION|0.242||0.05|TWO_SIDED|95.0|0.71|1.63||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.8 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.63|0.71|0.05
70896783|NCT02130193|141281886|SUPERIORITY_OR_OTHER||Posterior mean difference|1.15|STANDARD_DEVIATION|0.242||0.011|TWO_SIDED|95.0|0.71|1.63||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.7 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.63|0.71|0.011
70896784|NCT02130193|141281886|SUPERIORITY_OR_OTHER||Posterior mean difference|1.15|STANDARD_DEVIATION|0.242||0.002|TWO_SIDED|95.0|0.71|1.63||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.6 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.63|0.71|0.002
70896785|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.57|STANDARD_DEVIATION|2.04||0.62|TWO_SIDED|95.0|-4.55|3.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 1 month. Data presented are for 95% equal-tailed credible intervals|||3.23|-4.55|0.62
70896786|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.72|STANDARD_DEVIATION|2.21||0.64|TWO_SIDED|95.0|-5.03|3.6||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 2 month. Data presented are for 95% equal-tailed credible intervals|||3.60|-5.03|0.64
70896787|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.99|STANDARD_DEVIATION|2.29||0.81|TWO_SIDED|95.0|-6.6|2.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 3 month. Data presented are for 95% equal-tailed credible intervals|||2.27|-6.60|0.81
70896788|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.64|STANDARD_DEVIATION|2.31||0.77|TWO_SIDED|95.0|-5.92|3.07||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 4 month. Data presented are for 95% equal-tailed credible intervals|||3.07|-5.92|0.77
70896789|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.3|STANDARD_DEVIATION|2.4||0.71|TWO_SIDED|95.0|-5.7|3.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 5 month. Data presented are for 95% equal-tailed credible intervals|||3.55|-5.70|0.71
70896790|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.31|STANDARD_DEVIATION|2.42||0.7|TWO_SIDED|95.0|-6.46|3.05||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 6 month. Data presented are for 95% equal-tailed credible intervals|||3.05|-6.46|0.70
70896791|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.6|STANDARD_DEVIATION|2.45||0.74|TWO_SIDED|95.0|-6.75|2.9||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 7 month. Data presented are for 95% equal-tailed credible intervals|||2.90|-6.75|0.74
70896792|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-2.1|STANDARD_DEVIATION|2.63||0.79|TWO_SIDED|95.0|-6.93|3.3||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 8 month. Data presented are for 95% equal-tailed credible intervals|||3.30|-6.93|0.79
70896793|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.92|STANDARD_DEVIATION|2.63||0.77|TWO_SIDED|95.0|-7.04|3.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 9 month. Data presented are for 95% equal-tailed credible intervals|||3.18|-7.04|0.77
70896794|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-3.44|STANDARD_DEVIATION|2.72||0.9|TWO_SIDED|95.0|-8.74|1.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 10 month. Data presented are for 95% equal-tailed credible intervals|||1.87|-8.74|0.90
70896795|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.16|STANDARD_DEVIATION|2.72||0.66|TWO_SIDED|95.0|-6.2|4.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 11 month. Data presented are for 95% equal-tailed credible intervals|||4.20|-6.20|0.66
70896796|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.73|STANDARD_DEVIATION|2.7||0.74|TWO_SIDED|95.0|-6.91|3.45||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 12 month. Data presented are for 95% equal-tailed credible intervals|||3.45|-6.91|0.74
70896797|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.57|STANDARD_DEVIATION|2.04||0.43|TWO_SIDED|95.0|-4.55|3.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 1 month. Data presented are for 95% equal-tailed credible intervals|||3.23|-4.55|0.43
70896798|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.72|STANDARD_DEVIATION|2.21||0.45|TWO_SIDED|95.0|-5.03|3.6||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 2 month. Data presented are for 95% equal-tailed credible intervals|||3.60|-5.03|0.45
70896799|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.99|STANDARD_DEVIATION|2.29||0.67|TWO_SIDED|95.0|-6.6|2.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 3 month. Data presented are for 95% equal-tailed credible intervals|||2.27|-6.60|0.67
70896800|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.64|STANDARD_DEVIATION|2.31||0.62|TWO_SIDED|95.0|-5.92|3.07||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 4 month. Data presented are for 95% equal-tailed credible intervals|||3.07|-5.92|0.62
70896801|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.3|STANDARD_DEVIATION|2.4||0.55|TWO_SIDED|95.0|-5.7|3.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 5 month. Data presented are for 95% equal-tailed credible intervals|||3.55|-5.70|0.55
70896802|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.31|STANDARD_DEVIATION|2.42||0.55|TWO_SIDED|95.0|-6.46|3.05||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 6 month. Data presented are for 95% equal-tailed credible intervals|||3.05|-6.46|0.55
70896803|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.6|STANDARD_DEVIATION|2.45||0.59|TWO_SIDED|95.0|-6.75|2.9||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 7 month. Data presented are for 95% equal-tailed credible intervals|||2.90|-6.75|0.59
70896804|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-2.1|STANDARD_DEVIATION|2.63||0.65|TWO_SIDED|95.0|-6.93|3.3||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 8 month. Data presented are for 95% equal-tailed credible intervals|||3.30|-6.93|0.65
70896805|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.92|STANDARD_DEVIATION|2.63||0.63|TWO_SIDED|95.0|-7.04|3.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 9 month. Data presented are for 95% equal-tailed credible intervals|||3.18|-7.04|0.63
70896806|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-3.44|STANDARD_DEVIATION|2.72||0.81|TWO_SIDED|95.0|-8.74|1.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 10 month. Data presented are for 95% equal-tailed credible intervals|||1.87|-8.74|0.81
70896807|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.16|STANDARD_DEVIATION|2.72||0.52|TWO_SIDED|95.0|-6.2|4.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 11 month. Data presented are for 95% equal-tailed credible intervals|||4.20|-6.20|0.52
70896808|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.73|STANDARD_DEVIATION|2.7||0.6|TWO_SIDED|95.0|-6.91|3.45||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 12 month. Data presented are for 95% equal-tailed credible intervals|||3.45|-6.91|0.60
70896809|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.57|STANDARD_DEVIATION|2.04||0.24|TWO_SIDED|95.0|-4.55|3.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 1 month. Data presented are for 95% equal-tailed credible intervals|||3.23|-4.55|0.24
70896810|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.72|STANDARD_DEVIATION|2.21||0.28|TWO_SIDED|95.0|-5.03|3.6||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 2 month. Data presented are for 95% equal-tailed credible intervals|||3.60|-5.03|0.28
70896811|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.99|STANDARD_DEVIATION|2.29||0.5|TWO_SIDED|95.0|-6.6|2.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 3 month. Data presented are for 95% equal-tailed credible intervals|||2.27|-6.60|0.50
70896812|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.64|STANDARD_DEVIATION|2.31||0.43|TWO_SIDED|95.0|-5.92|3.07||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 4 month. Data presented are for 95% equal-tailed credible intervals|||3.07|-5.92|0.43
70896813|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.3|STANDARD_DEVIATION|2.4||0.37|TWO_SIDED|95.0|-5.7|3.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 5 month. Data presented are for 95% equal-tailed credible intervals|||3.55|-5.70|0.37
70896814|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.31|STANDARD_DEVIATION|2.42||0.38|TWO_SIDED|95.0|-6.46|3.05||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 6 month. Data presented are for 95% equal-tailed credible intervals|||3.05|-6.46|0.38
70896815|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.6|STANDARD_DEVIATION|2.45||0.43|TWO_SIDED|95.0|-6.75|2.9||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 7 month. Data presented are for 95% equal-tailed credible intervals|||2.90|-6.75|0.43
70896816|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-2.1|STANDARD_DEVIATION|2.63||0.51|TWO_SIDED|95.0|-6.93|3.3||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 8 month. Data presented are for 95% equal-tailed credible intervals|||3.30|-6.93|0.51
70896817|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.92|STANDARD_DEVIATION|2.63||0.5|TWO_SIDED|95.0|-7.04|3.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 9 month. Data presented are for 95% equal-tailed credible intervals|||3.18|-7.04|0.50
70896818|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-3.44|STANDARD_DEVIATION|2.72||0.7|TWO_SIDED|95.0|-8.74|1.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 10 month. Data presented are for 95% equal-tailed credible intervals|||1.87|-8.74|0.70
70896819|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.16|STANDARD_DEVIATION|2.72||0.38|TWO_SIDED|95.0|-6.2|4.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 11 month. Data presented are for 95% equal-tailed credible intervals|||4.20|-6.20|0.38
70896820|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.73|STANDARD_DEVIATION|2.7||0.45|TWO_SIDED|95.0|-6.91|3.45||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 12 month. Data presented are for 95% equal-tailed credible intervals|||3.45|-6.91|0.45
70896821|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.57|STANDARD_DEVIATION|2.04||0.11|TWO_SIDED|95.0|-4.55|3.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 1 month. Data presented are for 95% equal-tailed credible intervals|||3.23|-4.55|0.11
70896822|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.72|STANDARD_DEVIATION|2.21||0.15|TWO_SIDED|95.0|-5.03|3.6||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 2 month. Data presented are for 95% equal-tailed credible intervals|||3.60|-5.03|0.15
70896823|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.99|STANDARD_DEVIATION|2.29||0.32|TWO_SIDED|95.0|-6.6|2.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 3 month. Data presented are for 95% equal-tailed credible intervals|||2.27|-6.60|0.32
70896824|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.64|STANDARD_DEVIATION|2.31||0.28|TWO_SIDED|95.0|-5.92|3.07||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 4 month. Data presented are for 95% equal-tailed credible intervals|||3.07|-5.92|0.28
70896825|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.3|STANDARD_DEVIATION|2.4||0.23|TWO_SIDED|95.0|-5.7|3.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 5 month. Data presented are for 95% equal-tailed credible intervals|||3.55|-5.70|0.23
70896826|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.31|STANDARD_DEVIATION|2.42||0.24|TWO_SIDED|95.0|-6.46|3.05||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 6 month. Data presented are for 95% equal-tailed credible intervals|||3.05|-6.46|0.24
70896827|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.6|STANDARD_DEVIATION|2.45||0.29|TWO_SIDED|95.0|-6.75|2.9||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 7 month. Data presented are for 95% equal-tailed credible intervals|||2.90|-6.75|0.29
70896828|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-2.1|STANDARD_DEVIATION|2.63||0.36|TWO_SIDED|95.0|-6.93|3.3||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 8 month. Data presented are for 95% equal-tailed credible intervals|||3.30|-6.93|0.36
70896829|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.92|STANDARD_DEVIATION|2.63||0.35|TWO_SIDED|95.0|-7.04|3.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 9 month. Data presented are for 95% equal-tailed credible intervals|||3.18|-7.04|0.35
70896830|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-3.44|STANDARD_DEVIATION|2.72||0.57|TWO_SIDED|95.0|-8.74|1.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 10 month. Data presented are for 95% equal-tailed credible intervals|||1.87|-8.74|0.57
70896831|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.16|STANDARD_DEVIATION|2.72||0.25|TWO_SIDED|95.0|-6.2|4.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 11 month. Data presented are for 95% equal-tailed credible intervals|||4.20|-6.20|0.25
70896832|NCT02130193|141281887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.73|STANDARD_DEVIATION|2.7||0.32|TWO_SIDED|95.0|-6.91|3.45||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 12 month. Data presented are for 95% equal-tailed credible intervals|||3.45|-6.91|0.32
70896833|NCT02130193|141281888|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.477|TWO_SIDED|95.0|0.55|1.82||Posterior probability that the treatment ratio (DNX 75 mg/ placebo) is less than 1.0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.82|0.55|0.477
70896834|NCT02130193|141281888|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.343|TWO_SIDED|95.0|0.55|1.82||Posterior probability that the treatment ratio (DNX 75 mg/ placebo) is less than 0.9 is presented.|Bayesian analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.82|0.55|0.343
70896835|NCT02130193|141281888|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.221|TWO_SIDED|95.0|0.55|1.82||Posterior probability that the treatment ratio (DNX 75 mg/ placebo) is less than 0.8 is presented.|Bayesian analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.82|0.55|0.221
70896836|NCT02130193|141281888|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.116|TWO_SIDED|95.0|0.55|1.82||Posterior probability that the treatment ratio (DNX 75 mg/ placebo) is less than 0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.82|0.55|0.116
70896837|NCT02130193|141281888|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.052|TWO_SIDED|95.0|0.55|1.82||Posterior probability that the treatment ratio (DNX 75 mg/ placebo) is less than 0.6 is presented.|Bayesian analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.82|0.55|0.052
70896838|NCT02130193|141281889|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.212|TWO_SIDED|95.0|0.73|2.11||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 1.0 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||2.11|0.73|0.212
70896839|NCT02130193|141281889|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.111|TWO_SIDED|95.0|0.73|2.11||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.9 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||2.11|0.73|0.111
70896840|NCT02130193|141281889|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.049|TWO_SIDED|95.0|0.73|2.11||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.8 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||2.11|0.73|0.049
70896841|NCT02130193|141281889|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.012|TWO_SIDED|95.0|0.73|2.11||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.7 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||2.11|0.73|0.012
70896842|NCT02130193|141281889|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.001|TWO_SIDED|95.0|0.73|2.11||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.6 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||2.11|0.73|0.001
70896843|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.23|STANDARD_DEVIATION|0.72||0.64|TWO_SIDED|95.0|-1.53|1.25||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 1 month. Data presented are for 95% equal-tailed credible intervals|||1.25|-1.53|0.64
70896844|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.53|STANDARD_DEVIATION|0.78||0.75|TWO_SIDED|95.0|-1.91|1.1||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 2 month. Data presented are for 95% equal-tailed credible intervals|||1.10|-1.91|0.75
70896845|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.6|STANDARD_DEVIATION|0.8||0.77|TWO_SIDED|95.0|-2.09|0.98||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.98|-2.09|0.77
70896846|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.55|STANDARD_DEVIATION|0.81||0.74|TWO_SIDED|95.0|-2.23|0.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.87|-2.23|0.74
70896847|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|0.83||0.67|TWO_SIDED|95.0|-1.88|1.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 5 month. Data presented are for 95% equal-tailed credible intervals|||1.27|-1.88|0.67
70896848|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.43|STANDARD_DEVIATION|0.86||0.69|TWO_SIDED|95.0|-1.99|1.26||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 6 month. Data presented are for 95% equal-tailed credible intervals|||1.26|-1.99|0.69
70896849|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.5|STANDARD_DEVIATION|0.85||0.72|TWO_SIDED|95.0|-2.1|1.08||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 7 month. Data presented are for 95% equal-tailed credible intervals|||1.08|-2.10|0.72
70896850|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.5|STANDARD_DEVIATION|0.87||0.71|TWO_SIDED|95.0|-2.11|1.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 8 month. Data presented are for 95% equal-tailed credible intervals|||1.14|-2.11|0.71
70896851|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.34|STANDARD_DEVIATION|0.88||0.66|TWO_SIDED|95.0|-2.14|1.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 9 month. Data presented are for 95% equal-tailed credible intervals|||1.23|-2.14|0.66
70896852|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.89|STANDARD_DEVIATION|0.89||0.84|TWO_SIDED|95.0|-2.71|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-2.71|0.84
70896853|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|0.91||0.65|TWO_SIDED|95.0|-2.15|1.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 11 month. Data presented are for 95% equal-tailed credible intervals|||1.41|-2.15|0.65
70896854|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.49|STANDARD_DEVIATION|0.9||0.71|TWO_SIDED|95.0|-2.36|1.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 12 month. Data presented are for 95% equal-tailed credible intervals|||1.13|-2.36|0.71
70896855|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.23|STANDARD_DEVIATION|0.72||0.13|TWO_SIDED|95.0|-1.53|1.25||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 1 month. Data presented are for 95% equal-tailed credible intervals|||1.25|-1.53|0.13
70896856|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.53|STANDARD_DEVIATION|0.78||0.27|TWO_SIDED|95.0|-1.91|1.1||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 2 month. Data presented are for 95% equal-tailed credible intervals|||1.10|-1.91|0.27
70896857|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.6|STANDARD_DEVIATION|0.8||0.31|TWO_SIDED|95.0|-2.09|0.98||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.98|-2.09|0.31
70896858|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.55|STANDARD_DEVIATION|0.81||0.29|TWO_SIDED|95.0|-2.23|0.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.87|-2.23|0.29
70896859|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|0.83||0.23|TWO_SIDED|95.0|-1.88|1.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 5 month. Data presented are for 95% equal-tailed credible intervals|||1.27|-1.88|0.23
70896860|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.43|STANDARD_DEVIATION|0.86||0.26|TWO_SIDED|95.0|-1.99|1.26||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 6 month. Data presented are for 95% equal-tailed credible intervals|||1.26|-1.99|0.26
70896861|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.5|STANDARD_DEVIATION|0.85||0.28|TWO_SIDED|95.0|-2.1|1.08||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 7 month. Data presented are for 95% equal-tailed credible intervals|||1.08|-2.10|0.28
70896862|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.5|STANDARD_DEVIATION|0.87||0.29|TWO_SIDED|95.0|-2.11|1.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 8 month. Data presented are for 95% equal-tailed credible intervals|||1.14|-2.11|0.29
70896863|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.34|STANDARD_DEVIATION|0.88||0.23|TWO_SIDED|95.0|-2.14|1.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 9 month. Data presented are for 95% equal-tailed credible intervals|||1.23|-2.14|0.23
70896864|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.89|STANDARD_DEVIATION|0.89||0.45|TWO_SIDED|95.0|-2.71|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-2.71|0.45
70896865|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|0.91||0.24|TWO_SIDED|95.0|-2.15|1.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 11 month. Data presented are for 95% equal-tailed credible intervals|||1.41|-2.15|0.24
70896866|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.49|STANDARD_DEVIATION|0.9||0.28|TWO_SIDED|95.0|-2.36|1.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 12 month. Data presented are for 95% equal-tailed credible intervals|||1.13|-2.36|0.28
70896867|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.23|STANDARD_DEVIATION|0.72||0.26|TWO_SIDED|95.0|-1.53|1.25||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 1 month. Data presented are for 95% equal-tailed credible intervals|||1.25|-1.53|0.26
70896868|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.53|STANDARD_DEVIATION|0.78||0.41|TWO_SIDED|95.0|-1.91|1.1||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 2 month. Data presented are for 95% equal-tailed credible intervals|||1.10|-1.91|0.41
70896869|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.6|STANDARD_DEVIATION|0.8||0.46|TWO_SIDED|95.0|-2.09|0.98||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.98|-2.09|0.46
70896870|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.55|STANDARD_DEVIATION|0.81||0.43|TWO_SIDED|95.0|-2.23|0.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.87|-2.23|0.43
70896871|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|0.83||0.36|TWO_SIDED|95.0|-1.88|1.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 5 month. Data presented are for 95% equal-tailed credible intervals|||1.27|-1.88|0.36
70896872|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.43|STANDARD_DEVIATION|0.86||0.39|TWO_SIDED|95.0|-1.99|1.26||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 6 month. Data presented are for 95% equal-tailed credible intervals|||1.26|-1.99|0.39
70896873|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.5|STANDARD_DEVIATION|0.85||0.42|TWO_SIDED|95.0|-2.1|1.08||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 7 month. Data presented are for 95% equal-tailed credible intervals|||1.08|-2.10|0.42
70896874|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.5|STANDARD_DEVIATION|0.87||0.42|TWO_SIDED|95.0|-2.11|1.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 8 month. Data presented are for 95% equal-tailed credible intervals|||1.14|-2.11|0.42
70896875|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.34|STANDARD_DEVIATION|0.88||0.35|TWO_SIDED|95.0|-2.14|1.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 9 month. Data presented are for 95% equal-tailed credible intervals|||1.23|-2.14|0.35
70896876|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.89|STANDARD_DEVIATION|0.89||0.58|TWO_SIDED|95.0|-2.71|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-2.71|0.58
70896877|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|0.91||0.36|TWO_SIDED|95.0|-2.15|1.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 11 month. Data presented are for 95% equal-tailed credible intervals|||1.41|-2.15|0.36
70896878|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.49|STANDARD_DEVIATION|0.9||0.41|TWO_SIDED|95.0|-2.36|1.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 12 month. Data presented are for 95% equal-tailed credible intervals|||1.13|-2.36|0.41
70896879|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.14|STANDARD_DEVIATION|0.35||0.66|TWO_SIDED|95.0|-0.84|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 1 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-0.84|0.66
70896880|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.17|STANDARD_DEVIATION|0.39||0.66|TWO_SIDED|95.0|-0.94|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 2 month. Data presented are for 95% equal-tailed credible intervals|||0.55|-0.94|0.66
70896881|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.56|STANDARD_DEVIATION|0.43||0.91|TWO_SIDED|95.0|-1.46|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.20|-1.46|0.91
70896882|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.32|STANDARD_DEVIATION|0.41||0.79|TWO_SIDED|95.0|-1.16|0.44||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.44|-1.16|0.79
70896883|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.4|STANDARD_DEVIATION|0.42||0.84|TWO_SIDED|95.0|-1.24|0.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 5 month. Data presented are for 95% equal-tailed credible intervals|||0.41|-1.24|0.84
70896884|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.39|STANDARD_DEVIATION|0.44||0.81|TWO_SIDED|95.0|-1.23|0.47||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 6 month. Data presented are for 95% equal-tailed credible intervals|||0.47|-1.23|0.81
70896885|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.32|STANDARD_DEVIATION|0.44||0.76|TWO_SIDED|95.0|-1.14|0.56||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 7 month. Data presented are for 95% equal-tailed credible intervals|||0.56|-1.14|0.76
70896886|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.48|STANDARD_DEVIATION|0.48||0.84|TWO_SIDED|95.0|-1.43|0.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 8 month. Data presented are for 95% equal-tailed credible intervals|||0.43|-1.43|0.84
70896887|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.46|STANDARD_DEVIATION|0.49||0.83|TWO_SIDED|95.0|-1.49|0.38||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 9 month. Data presented are for 95% equal-tailed credible intervals|||0.38|-1.49|0.83
70896888|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.73|STANDARD_DEVIATION|0.49||0.94|TWO_SIDED|95.0|-1.68|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.20|-1.68|0.94
70896889|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.49|STANDARD_DEVIATION|0.5||0.84|TWO_SIDED|95.0|-1.45|0.48||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 11 month. Data presented are for 95% equal-tailed credible intervals|||0.48|-1.45|0.84
70896890|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.43|STANDARD_DEVIATION|0.5||0.81|TWO_SIDED|95.0|-1.36|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 12 month. Data presented are for 95% equal-tailed credible intervals|||0.55|-1.36|0.81
70896891|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.14|STANDARD_DEVIATION|0.35||0.01|TWO_SIDED|95.0|-0.84|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 1 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-0.84|0.01
70896892|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.17|STANDARD_DEVIATION|0.39||0.02|TWO_SIDED|95.0|-0.94|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 2 month. Data presented are for 95% equal-tailed credible intervals|||0.55|-0.94|0.02
70896893|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.56|STANDARD_DEVIATION|0.43||0.15|TWO_SIDED|95.0|-1.46|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.20|-1.46|0.15
70896894|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.32|STANDARD_DEVIATION|0.41||0.05|TWO_SIDED|95.0|-1.16|0.44||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.44|-1.16|0.05
70896895|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.4|STANDARD_DEVIATION|0.42||0.08|TWO_SIDED|95.0|-1.24|0.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 5 month. Data presented are for 95% equal-tailed credible intervals|||0.41|-1.24|0.08
70896896|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.39|STANDARD_DEVIATION|0.44||0.08|TWO_SIDED|95.0|-1.23|0.47||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 6 month. Data presented are for 95% equal-tailed credible intervals|||0.47|-1.23|0.08
70896897|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.32|STANDARD_DEVIATION|0.44||0.06|TWO_SIDED|95.0|-1.14|0.56||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 7 month. Data presented are for 95% equal-tailed credible intervals|||0.56|-1.14|0.06
70896898|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.48|STANDARD_DEVIATION|0.48||0.14|TWO_SIDED|95.0|-1.43|0.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 8 month. Data presented are for 95% equal-tailed credible intervals|||0.43|-1.43|0.14
70896899|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.46|STANDARD_DEVIATION|0.49||0.14|TWO_SIDED|95.0|-1.49|0.38||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 9 month. Data presented are for 95% equal-tailed credible intervals|||0.38|-1.49|0.14
70896900|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.73|STANDARD_DEVIATION|0.49||0.29|TWO_SIDED|95.0|-1.68|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.20|-1.68|0.29
70896901|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.49|STANDARD_DEVIATION|0.5||0.15|TWO_SIDED|95.0|-1.45|0.48||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 11 month. Data presented are for 95% equal-tailed credible intervals|||0.48|-1.45|0.15
70896902|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.43|STANDARD_DEVIATION|0.5||0.13|TWO_SIDED|95.0|-1.36|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 12 month. Data presented are for 95% equal-tailed credible intervals|||0.55|-1.36|0.13
70896903|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.14|STANDARD_DEVIATION|0.35||0.06|TWO_SIDED|95.0|-0.84|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 1 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-0.84|0.06
70896904|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.17|STANDARD_DEVIATION|0.39||0.09|TWO_SIDED|95.0|-0.94|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 2 month. Data presented are for 95% equal-tailed credible intervals|||0.55|-0.94|0.09
70896905|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.56|STANDARD_DEVIATION|0.43||0.37|TWO_SIDED|95.0|-1.46|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.20|-1.46|0.37
70896906|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.32|STANDARD_DEVIATION|0.41||0.18|TWO_SIDED|95.0|-1.16|0.44||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.44|-1.16|0.18
70896907|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.4|STANDARD_DEVIATION|0.42||0.24|TWO_SIDED|95.0|-1.24|0.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 5 month. Data presented are for 95% equal-tailed credible intervals|||0.41|-1.24|0.24
70896908|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.39|STANDARD_DEVIATION|0.44||0.24|TWO_SIDED|95.0|-1.23|0.47||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 6 month. Data presented are for 95% equal-tailed credible intervals|||0.47|-1.23|0.24
70896909|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.32|STANDARD_DEVIATION|0.44||0.19|TWO_SIDED|95.0|-1.14|0.56||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 7 month. Data presented are for 95% equal-tailed credible intervals|||0.56|-1.14|0.19
70896910|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.48|STANDARD_DEVIATION|0.48||0.32|TWO_SIDED|95.0|-1.43|0.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 8 month. Data presented are for 95% equal-tailed credible intervals|||0.43|-1.43|0.32
70896911|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.46|STANDARD_DEVIATION|0.49||0.32|TWO_SIDED|95.0|-1.49|0.38||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 9 month. Data presented are for 95% equal-tailed credible intervals|||0.38|-1.49|0.32
70896912|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.73|STANDARD_DEVIATION|0.49||0.52|TWO_SIDED|95.0|-1.68|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.20|-1.68|0.52
70896913|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.49|STANDARD_DEVIATION|0.5||0.33|TWO_SIDED|95.0|-1.45|0.48||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 11 month. Data presented are for 95% equal-tailed credible intervals|||0.48|-1.45|0.33
70896914|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.43|STANDARD_DEVIATION|0.5||0.29|TWO_SIDED|95.0|-1.36|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 12 month. Data presented are for 95% equal-tailed credible intervals|||0.55|-1.36|0.29
70896915|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.31||0.43|TWO_SIDED|95.0|-0.59|0.62||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 1 month. Data presented are for 95% equal-tailed credible intervals|||0.62|-0.59|0.43
70896916|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|0.19|STANDARD_DEVIATION|0.35||0.29|TWO_SIDED|95.0|-0.53|0.85||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 2 month. Data presented are for 95% equal-tailed credible intervals|||0.85|-0.53|0.29
70896917|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.2|STANDARD_DEVIATION|0.38||0.7|TWO_SIDED|95.0|-0.94|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-0.94|0.70
70896918|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.21|STANDARD_DEVIATION|0.37||0.71|TWO_SIDED|95.0|-0.92|0.5||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.50|-0.92|0.71
70896919|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.11|STANDARD_DEVIATION|0.37||0.61|TWO_SIDED|95.0|-0.82|0.61||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 5 month. Data presented are for 95% equal-tailed credible intervals|||0.61|-0.82|0.61
70896920|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|0.02|STANDARD_DEVIATION|0.36||0.48|TWO_SIDED|95.0|-0.69|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 6 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-0.69|0.48
70896921|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.08|STANDARD_DEVIATION|0.36||0.58|TWO_SIDED|95.0|-0.79|0.62||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 7 month. Data presented are for 95% equal-tailed credible intervals|||0.62|-0.79|0.58
70896922|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.39|STANDARD_DEVIATION|0.4||0.83|TWO_SIDED|95.0|-1.12|0.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 8 month. Data presented are for 95% equal-tailed credible intervals|||0.43|-1.12|0.83
70896923|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.26|STANDARD_DEVIATION|0.41||0.74|TWO_SIDED|95.0|-1.07|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 9 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-1.07|0.74
70896924|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.53|STANDARD_DEVIATION|0.43||0.89|TWO_SIDED|95.0|-1.4|0.29||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.29|-1.40|0.89
70896925|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.1|STANDARD_DEVIATION|0.41||0.59|TWO_SIDED|95.0|-0.89|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 11 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-0.89|0.59
70896926|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.3|STANDARD_DEVIATION|0.42||0.77|TWO_SIDED|95.0|-1.12|0.54||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 12 month. Data presented are for 95% equal-tailed credible intervals|||0.54|-1.12|0.77
70896927|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.31||0.01|TWO_SIDED|95.0|-0.59|0.62||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 1 month. Data presented are for 95% equal-tailed credible intervals|||0.62|-0.59|0.01
70896928|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|0.19|STANDARD_DEVIATION|0.35||0.01|TWO_SIDED|95.0|-0.53|0.85||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 2 month. Data presented are for 95% equal-tailed credible intervals|||0.85|-0.53|0.01
70896929|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.2|STANDARD_DEVIATION|0.38||0.09|TWO_SIDED|95.0|-0.94|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-0.94|0.09
70896930|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.21|STANDARD_DEVIATION|0.37||0.09|TWO_SIDED|95.0|-0.92|0.5||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.50|-0.92|0.09
70896931|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.11|STANDARD_DEVIATION|0.37||0.05|TWO_SIDED|95.0|-0.82|0.61||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 5 month. Data presented are for 95% equal-tailed credible intervals|||0.61|-0.82|0.05
70896932|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|0.02|STANDARD_DEVIATION|0.36||0.02|TWO_SIDED|95.0|-0.69|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 6 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-0.69|0.02
70896933|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.08|STANDARD_DEVIATION|0.36||0.04|TWO_SIDED|95.0|-0.79|0.62||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 7 month. Data presented are for 95% equal-tailed credible intervals|||0.62|-0.79|0.04
70896934|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.39|STANDARD_DEVIATION|0.4||0.22|TWO_SIDED|95.0|-1.12|0.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 8 month. Data presented are for 95% equal-tailed credible intervals|||0.43|-1.12|0.22
70896935|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.26|STANDARD_DEVIATION|0.41||0.14|TWO_SIDED|95.0|-1.07|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 9 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-1.07|0.14
70896936|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.53|STANDARD_DEVIATION|0.43||0.36|TWO_SIDED|95.0|-1.4|0.29||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.29|-1.40|0.36
70896937|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.1|STANDARD_DEVIATION|0.41||0.07|TWO_SIDED|95.0|-0.89|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 11 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-0.89|0.07
70896938|NCT02130193|141281892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.3|STANDARD_DEVIATION|0.42||0.17|TWO_SIDED|95.0|-1.12|0.54||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 12 month. Data presented are for 95% equal-tailed credible intervals|||0.54|-1.12|0.17
70896939|NCT01212770|141281897|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|22.3|||<|0.0001|TWO_SIDED|95.0|13.0|31.6|||Cochran-Mantel-Haenszel|Adjusted for baseline disease modifying antirheumatic drug (DMARD) use and and ≥ 3% body surface area (BSA) psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|The percentage of participants with an ACR20 response was compared using a Cochran-Mantel- Haenszel (CMH) test. The Hochberg procedure was used to maintain the Type 1 error at the 0.05 significance level. The results were considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||31.6|13.0|<0.0001
70896940|NCT01212770|141281897|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|9.8||||0.0295|TWO_SIDED|95.0|1.1|18.6|||Cochran-Mantel-Haenszel|2-sided p-value based on the Cochran-Mantel-Haenszel test adjusting for baseline DMARD use and ≥ 3% BSA psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||18.6|1.1|0.0295
70896941|NCT01212770|141281898|SUPERIORITY||LS Mean Difference|-0.127||||0.0073|TWO_SIDED|95.0|-0.22|-0.034|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.034|-0.220|0.0073
70896942|NCT01212770|141281898|SUPERIORITY||LS Mean Difference|-0.066||||0.1619|TWO_SIDED|95.0|-0.158|0.027|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||0.027|-0.158|0.1619
70896943|NCT01212770|141281899|SUPERIORITY||Adjusted Difference|15.5||||0.0007|TWO_SIDED|95.0|6.7|24.3||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use and ≥ 3% BSA psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||24.3|6.7|0.0007
70896944|NCT01212770|141281899|SUPERIORITY||Adjusted Difference|11.1||||0.011|TWO_SIDED|95.0|2.7|19.5||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use and ≥ 3% BSA psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||19.5|2.7|0.0110
70896945|NCT01212770|141281900|SUPERIORITY||LS Mean Difference|-0.139||||0.005|TWO_SIDED|95.0|-0.236|-0.042|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||-0.042|-0.236|0.0050
70896946|NCT01212770|141281900|SUPERIORITY||LS Mean Difference|-0.084||||0.086|TWO_SIDED|95.0|-0.181|0.012|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||0.012|-0.181|0.0860
70896947|NCT01212770|141281901|SUPERIORITY||LS Mean Difference|2.32||||0.0053|TWO_SIDED|95.0|0.69|3.95|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||3.95|0.69|0.0053
70896948|NCT01212770|141281901|SUPERIORITY||LS mean Difference|1.15||||0.1658|TWO_SIDED|95.0|-0.48|2.77|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||2.77|-0.48|0.1658
70896949|NCT01212770|141281902|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|25.4|||<|0.0001|TWO_SIDED|95.0|15.5|35.3|||Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use and ≥ 3% BSA psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||35.3|15.5|<0.0001
70896950|NCT01212770|141281902|SUPERIORITY||Adjusted Difference|10.4||||0.0372|TWO_SIDED|95.0|0.8|20.0|||Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use and ≥ 3% BSA psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||20.0|0.8|0.0372
70896951|NCT01212770|141281903|SUPERIORITY||Adjusted Difference|14.6||||0.0062|TWO_SIDED|95.0|4.5|24.8|||Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across 2 strata of baseline DMARD use with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||24.8|4.5|0.0062
70896952|NCT01212770|141281903|SUPERIORITY||Adjusted Difference|13.0||||0.0134|TWO_SIDED|95.0|3.0|23.1|||Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across 2 strata of baseline DMARD use with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||23.1|3.0|0.0134
70896953|NCT01212770|141281904|SUPERIORITY||LS Mean Difference|-7.8||||0.0021|TWO_SIDED|95.0|-12.8|-2.9|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||-2.9|-12.8|0.0021
70896954|NCT01212770|141281904|SUPERIORITY||LS Mean Difference|-3.6||||0.1482|TWO_SIDED|95.0|-8.6|1.3|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||1.3|-8.6|0.1482
70896955|NCT01212770|141281905|SUPERIORITY||LS Mean Difference|-0.2||||0.5349|TWO_SIDED|95.0|-1.0|0.5|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.5|-1.0|0.5349
70896956|NCT01212770|141281905|SUPERIORITY||LS Mean Difference|0.1||||0.8231|TWO_SIDED|95.0|-0.7|0.9|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.9|-0.7|0.8231
70896957|NCT01212770|141281906|SUPERIORITY||LS Mean Difference|-0.8||||0.072|TWO_SIDED|95.0|-1.7|0.1|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.1|-1.7|0.0720
70896958|NCT01212770|141281906|SUPERIORITY||LS Mean Difference|-0.4||||0.3641|TWO_SIDED|95.0|-1.3|0.5|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.5|-1.3|0.3641
70896959|NCT01212770|141281907|SUPERIORITY||LS Mean Difference|-4.94||||0.0001|TWO_SIDED|95.0|-7.34|-2.53|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-2.53|-7.34|0.0001
70896960|NCT01212770|141281907|SUPERIORITY||LS Mean Difference|-1.85||||0.1325|TWO_SIDED|95.0|-4.27|0.56|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.56|-4.27|0.1325
70896961|NCT01212770|141281908|SUPERIORITY||LS Mean Difference|-0.47||||0.0001|TWO_SIDED|95.0|-0.7|-0.24|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-0.24|-0.70|0.0001
70896962|NCT01212770|141281908|SUPERIORITY||LS Mean Difference|-0.27||||0.0237|TWO_SIDED|95.0|-0.5|-0.04|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-0.04|-0.50|0.0237
70896963|NCT01212770|141281909|SUPERIORITY||LS Mean Difference|2.54||||0.0049|TWO_SIDED|95.0|0.77|4.3|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||4.30|0.77|0.0049
70896964|NCT01212770|141281909|SUPERIORITY||LS Mean Difference|0.68||||0.4505|TWO_SIDED|95.0|-1.09|2.44|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||2.44|-1.09|0.4505
70896965|NCT01212770|141281910|SUPERIORITY||LS Mean Difference|2.34||||0.0043|TWO_SIDED|95.0|0.74|3.94|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||3.94|0.74|0.0043
70896966|NCT01212770|141281910|SUPERIORITY||LS Mean Difference|1.67||||0.0404|TWO_SIDED|95.0|0.07|3.27|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||3.27|0.07|0.0404
70896967|NCT01212770|141281911|SUPERIORITY||Adjusted Difference|21.2|||<|0.0001|TWO_SIDED|95.0|11.5|30.9|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use and and involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||30.9|11.5|< 0.0001
70896968|NCT01212770|141281911|SUPERIORITY||Adjusted Difference|8.7||||0.0661|TWO_SIDED|95.0|-0.5|18.0|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||18.0|-0.5|0.0661
70896969|NCT01212770|141281912|SUPERIORITY||Adjusted Difference|14.8||||0.0099|TWO_SIDED|95.0|3.8|25.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use|Adjusted difference is the weighted average of the treatment differences across 2 strata of baseline DMARD use with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||25.7|3.8|0.0099
70896970|NCT01212770|141281912|SUPERIORITY||Adjusted Difference|10.8||||0.0515|TWO_SIDED|95.0|0.1|21.4|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use|Adjusted difference is the weighted average of the treatment differences across 2 strata of baseline DMARD use with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||21.4|0.1|0.0515
70896971|NCT01212770|141281913|SUPERIORITY||LS mean Difference|-6.6||||0.008|TWO_SIDED|95.0|-11.4|-1.7|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-1.7|-11.4|0.0080
70896972|NCT01212770|141281913|SUPERIORITY||LS Mean Difference|-3.8||||0.1218|TWO_SIDED|95.0|-8.6|1.0|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||1.0|-8.6|0.1218
70896973|NCT01212770|141281914|SUPERIORITY||LS Mean Difference|-0.4||||0.2761|TWO_SIDED|95.0|-1.3|0.4|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.4|-1.3|0.2761
70896974|NCT01212770|141281914|SUPERIORITY||LS Mean Difference|-0.3||||0.5012|TWO_SIDED|95.0|-1.1|0.6|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.6|-1.1|0.5012
70896975|NCT01212770|141281915|SUPERIORITY||LS Mean Difference|-1.0||||0.0399|TWO_SIDED|95.0|-1.9|0.0|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-0.0|-1.9|0.0399
70896976|NCT01212770|141281915|SUPERIORITY||LS Mean Difference|-0.4||||0.4413|TWO_SIDED|95.0|-1.3|0.6|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.6|-1.3|0.4413
70896977|NCT01212770|141281916|SUPERIORITY||LS Mean Difference|-5.27|||<|0.0001|TWO_SIDED|95.0|-7.73|-2.82|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-2.82|-7.73|< 0.0001
70896978|NCT01212770|141281916|SUPERIORITY||LS Mean Difference|-2.65||||0.0349|TWO_SIDED|95.0|-5.11|-0.19|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-0.19|-5.11|0.0349
70896979|NCT01212770|141281917|SUPERIORITY||LS Mean Difference|-0.48||||0.0001|TWO_SIDED|95.0|-0.72|-0.24|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-0.24|-0.72|0.0001
70896980|NCT01212770|141281917|SUPERIORITY||LS Mean Difference|-0.3||||0.0147|TWO_SIDED|95.0|-0.54|-0.06|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-0.06|-0.54|0.0147
70896981|NCT01212770|141281918|SUPERIORITY||LS Mean Difference|2.44||||0.0078|TWO_SIDED|95.0|0.64|4.24|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||4.24|0.64|0.0078
70896982|NCT01212770|141281918|SUPERIORITY||LS Mean Difference|1.19||||0.1936|TWO_SIDED|95.0|-0.61|2.98|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||2.98|-0.61|0.1936
70896983|NCT01212770|141281919|SUPERIORITY||Adjusted Difference|2.1||||0.7585|TWO_SIDED|95.0|-10.9|15.0|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use and involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||15.0|-10.9|0.7585
70896984|NCT01212770|141281919|SUPERIORITY||Adjusted Difference|-3.9||||0.5808|TWO_SIDED|95.0|-17.4|9.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||9.7|-17.4|0.5808
70896985|NCT01212770|141281920|SUPERIORITY||Adjusted Difference|12.0||||0.1303|TWO_SIDED|95.0|-3.1|27.0|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD useinvolvement of \>= 3% BSA with psoriasis at baseline..|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||27.0|-3.1|0.1303
70896986|NCT01212770|141281920|SUPERIORITY||Adjusted Difference|7.5||||0.361|TWO_SIDED|95.0|-8.3|23.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||23.2|-8.3|0.3610
70896987|NCT01212770|141281921|SUPERIORITY||Adjusted Difference|22.5|||<|0.0001|TWO_SIDED|95.0|12.4|32.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||32.6|12.4|< 0.0001
70896988|NCT01212770|141281921|SUPERIORITY||Adjusted Difference|11.0||||0.0309|TWO_SIDED|95.0|1.2|20.9|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||20.9|1.2|0.0309
70896989|NCT01212770|141281922|SUPERIORITY||Adjusted Difference|3.8||||0.5731|TWO_SIDED|95.0|-9.1|16.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||16.7|-9.1|0.5731
70896990|NCT01212770|141281922|SUPERIORITY||Adjusted Difference|1.0||||0.8876|TWO_SIDED|95.0|-12.6|14.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||14.6|-12.6|0.8876
70896991|NCT01212770|141281923|SUPERIORITY||Adjusted Difference|12.2||||0.1172|TWO_SIDED|95.0|-2.5|26.9|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||26.9|-2.5|0.1172
70896992|NCT01212770|141281923|SUPERIORITY||Adjusted Difference|7.2||||0.3695|TWO_SIDED|95.0|-8.2|22.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||22.6|-8.2|0.3695
70896993|NCT01212770|141281924|SUPERIORITY||Adjusted Difference|22.5|||<|0.0001|TWO_SIDED|95.0|13.0|32.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||32.1|13.0|< 0.0001
70896994|NCT01212770|141281924|SUPERIORITY||Adjusted Difference|11.7||||0.0123|TWO_SIDED|95.0|2.7|20.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||20.7|2.7|0.0123
70896995|NCT01212770|141281925|SUPERIORITY||Adjusted Difference|6.8||||0.052|TWO_SIDED|95.0|0.0|13.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||13.5|0.0|0.0520
70896996|NCT01212770|141281925|SUPERIORITY||Adjusted Difference|4.2||||0.2052|TWO_SIDED|95.0|-2.2|10.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||10.6|-2.2|0.2052
70896997|NCT01212770|141281926|SUPERIORITY||Adjusted Difference|1.2||||0.5154|TWO_SIDED|95.0|-2.4|4.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||4.8|-2.4|0.5154
70896998|NCT01212770|141281926|SUPERIORITY||Adjusted Difference|2.3||||0.2527|TWO_SIDED|95.0|-1.5|6.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||6.2|-1.5|0.2527
70896999|NCT01212770|141281927|SUPERIORITY||Adjusted Difference|8.3||||0.018|TWO_SIDED|95.0|1.6|15.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||15.1|1.6|0.0180
70897000|NCT01212770|141281927|SUPERIORITY||Adjusted Difference|5.8||||0.0807|TWO_SIDED|95.0|-0.6|12.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||12.3|-0.6|0.0807
70897001|NCT01212770|141281928|SUPERIORITY||Adjusted Difference|1.8||||0.423|TWO_SIDED|95.0|-2.6|6.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||6.2|-2.6|0.4230
70897002|NCT01212770|141281928|SUPERIORITY||Adjusted Difference|0.6||||0.787|TWO_SIDED|95.0|-3.5|4.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||4.6|-3.5|0.7870
70897003|NCT01212770|141281929|SUPERIORITY||Adjusted Difference|-4.1||||0.4707|TWO_SIDED|95.0|-14.8|6.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||6.5|-14.8|0.4707
70897004|NCT01212770|141281929|SUPERIORITY||Adjusted Difference|-5.4||||0.3547|TWO_SIDED|95.0|-16.6|5.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||5.7|-16.6|0.3547
70897005|NCT01212770|141281930|SUPERIORITY||Adjusted Difference|6.6||||0.4175|TWO_SIDED|95.0|-8.6|21.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||21.8|-8.6|0.4175
70897006|NCT01212770|141281930|SUPERIORITY||Adjusted Difference|6.4||||0.437|TWO_SIDED|95.0|-9.1|21.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||21.8|-9.1|0.4370
70897007|NCT01212770|141281931|SUPERIORITY||Adjusted Difference|-0.4||||0.9463|TWO_SIDED|195.0|-12.1|11.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||11.3|-12.1|0.9463
70897008|NCT01212770|141281931|SUPERIORITY||Adjusted Difference|-7.7||||0.2032|TWO_SIDED|95.0|-19.3|3.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||3.8|-19.3|0.2032
70897009|NCT01212770|141281932|SUPERIORITY||Adjusted Difference|9.8||||0.2321|TWO_SIDED|95.0|-5.8|25.4|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||25.4|-5.8|0.2321
70897010|NCT01212770|141281932|SUPERIORITY||Adjusted Difference|9.6||||0.252|TWO_SIDED|95.0|-6.2|25.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||25.3|-6.2|0.2520
70897011|NCT00829387|141281953|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.39||||0.47|TWO_SIDED|95.0|-1.47|0.69|||Linear mixed model|||||0.69|-1.47|0.47
70897012|NCT00829387|141281954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.4|TWO_SIDED|95.0|-1.15|0.47|||linear mixed model|||baseline to 36 weeks post-baseline||0.47|-1.15|0.40
70897013|NCT00829387|141281955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35||||0.31|TWO_SIDED|95.0|-7.02|2.32|||Linear mixed model|||baseline to 12 weeks post-baseline||2.32|-7.02|0.31
70897014|NCT00829387|141281956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.98|TWO_SIDED|95.0|-1.03|1.06|||linear mixed model|||baseline to 12 weeks comparison||1.06|-1.03|0.98
70897015|NCT00829387|141281957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||0.03|TWO_SIDED|95.0|-1.76|-0.07|||linear mixed model|||baseline to 36 weeks post-baseline||-0.07|-1.76|0.03
70897016|NCT00829387|141281958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.16||||0.15|TWO_SIDED|95.0|-9.86|1.55|||linear mixed model|||baseline to 36 weeks post-baseline||1.55|-9.86|0.15
70897017|NCT00707031|141281975|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit of the 2-sided 95% confidence interval of the difference between lixisenatide and exenatide on mITT population was \<=0.4%.|Least squares (LS) mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.067|||TWO_SIDED|95.0|0.033|0.297||Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0, \>=8.0%), BMI (\<30, \>=30 kg/m\^2), country as fixed effects, baseline HbA1c as covariate.||||To detect that upper confidence limit of 2-sided 95% confidence interval for least square (LS) mean difference between the 2 arms do not exceed 0.4% HbA1c, 300 patients per group would provide 96% power assuming a standard deviation of 1.3 and true difference in HbA1c between the 2 arms as 0.||0.297|0.033|
70897018|NCT00182754|141281984|SUPERIORITY|||||||0.17|||||||Log Rank|||||||0.17
70897019|NCT02085252|141281995|SUPERIORITY_OR_OTHER|||||||0.0318||||||A 2-sided significance level of 5% was used. There was no adjustment for multiple comparisons.|Chi-squared|||The null hypothesis was that there was no difference between the two treatment strategies.||||0.0318
70897020|NCT01112579|141282033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4||||0.3|TWO_SIDED|95.0|-2.0|14.9|||ANCOVA|||||14.9|-2.0|0.3
70897021|NCT01112579|141282034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-106.1||||0.79|TWO_SIDED|95.0|-845.8|633.6|||ANCOVA|||||633.6|-845.8|0.79
70897022|NCT01112579|141282035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.93|TWO_SIDED|95.0|-1.6|3.2|||ANCOVA|||||3.2|-1.6|0.93
70897023|NCT01951625|141282052|OTHER||Log-Scale mean difference|-0.122|||=|0.1506|TWO_SIDED|90.0|-0.32|0.07|||t-test, 1 sided|||For the primary analysis, the three highest active treatment groups (BAY1021189 2.5mg, BAY1021189 2.5 to 5mg, BAY1021189 2.5 to 10mg) were pooled and compared to the assigned placebo treatment group with a one-sided two-sample t-test at the significance level of 5 percent (%). Results are reported including 90% confidence intervals (CI) for the difference of means. The difference between the pooled treatment group and the placebo group is difference of means on the log scale.||0.07|-0.32|= 0.1506
70897024|NCT01951625|141282052|OTHER||Log-Scale mean difference|-0.2494|||=|0.0483|TWO_SIDED|90.0|-0.5|0.0|||t-test, 1 sided|||In case of a significant result in the primary analysis of the primary endpoint, pairwise comparisons to Placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In case of non-significance of the primary analyses, these secondary analyses were specified as exploratory only, since the primary analyses were not significant.||0|-0.5|= 0.0483
70897025|NCT01951625|141282052|OTHER||Log-Scale mean difference|-0.0731|||=|0.3042|TWO_SIDED|90.0|-0.31|0.16|||t-test, 1 sided|||In case of a significant result in the primary analysis of the primary endpoint, pairwise comparisons to Placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In case of non-significance of the primary analyses, these secondary analyses were specified as exploratory only, since the primary analyses were not significant.||0.16|-0.31|= 0.3042
70897026|NCT01951625|141282052|OTHER||Log-Scale mean difference|-0.0396|||=|0.3841|TWO_SIDED|90.0|-0.26|0.18|||t-test, 1 sided|||In case of a significant result in the primary analysis of the primary endpoint, pairwise comparisons to Placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In case of non-significance of the primary analyses, these secondary analyses were specified as exploratory only, since the primary analyses were not significant.||0.18|-0.26|= 0.3841
70897027|NCT01951625|141282052|OTHER||Log-Scale mean difference|0.0151|||=|0.5444|TWO_SIDED|90.0|-0.21|0.24|||t-test, 1 sided|||In case of a significant result in the primary analysis of the primary endpoint, pairwise comparisons to Placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In case of non-significance of the primary analyses, these secondary analyses were specified as exploratory only.||0.24|-0.21|= 0.5444
70897028|NCT03355326|141282095|SUPERIORITY|||||||0.971|||||||Wilcoxon (Mann-Whitney)|||||||0.971
70897029|NCT03355326|141282096|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.900
70897030|NCT03355326|141282097|SUPERIORITY|||||||0.648|||||||Wilcoxon (Mann-Whitney)|||||||0.648
70897031|NCT03355326|141282098|SUPERIORITY|||||||0.967|||||||Wilcoxon (Mann-Whitney)|||||||0.967
70897032|NCT03355326|141282099|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
70897033|NCT03355326|141282100|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
70897034|NCT03355326|141282101|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
70897035|NCT01986881|141282116|NON_INFERIORITY|1-sided p-value and the non-inferiority margin is a hazard ratio of 1.3.|Hazard Ratio (HR)|0.97|||<|0.001|TWO_SIDED|95.6|0.848|1.114||Model included treatment as an explanatory factor and cohort category as a stratification factor.|Cox Proportional Hazards Model|||||1.114|0.848|<0.001
70897036|NCT01986881|141282116|NON_INFERIORITY|1-sided p-value and the non-inferiority margin is a hazard ratio of 1.3.|Hazard Ratio (HR)|1.04||||0.002|TWO_SIDED|95.6|0.887|1.211|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.211|0.887|0.002
70897037|NCT01986881|141282116|NON_INFERIORITY|1-sided p-value and the non-inferiority margin is a hazard ratio of 1.3.|Hazard Ratio (HR)|0.91|||<|0.001|TWO_SIDED|95.6|0.773|1.065|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.065|0.773|<0.001
70897038|NCT01986881|141282118|SUPERIORITY||Difference in the Least Squares Means|-0.65|||<|0.001|TWO_SIDED|95.0|-0.78|-0.51||"Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, stratum, and the interaction of time by treatment. The stratum was (insulin alone or insulin+metformin) and Time was a categorical variable."|cLDA Model|||||-0.51|-0.78|<0.001
70897039|NCT01986881|141282118|SUPERIORITY||Difference in the Least Squares Means|-0.58|||<|0.001|TWO_SIDED|95.0|-0.71|-0.44||"Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, stratum, and the interaction of time by treatment. The stratum was (insulin alone or insulin+metformin) and Time was a categorical variable."|Constrained longitudinal data analysis|||||-0.44|-0.71|<0.001
70897040|NCT01986881|141282120|SUPERIORITY||Difference in the Least Squares Means|-0.22||||0.247|TWO_SIDED|95.0|-0.6|0.16||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, and the interaction of time by treatment.|cLDA Model|||||0.16|-0.60|0.247
70897041|NCT01986881|141282120|SUPERIORITY||Difference in the Least Squares Means|-0.35||||0.063|TWO_SIDED|95.0|-0.72|0.02||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, and the interaction of time by treatment.|cLDA model|||||0.02|-0.72|0.063
70897042|NCT01986881|141282122|SUPERIORITY||Difference in the Least Squares Means|-0.75|||<|0.001|TWO_SIDED|95.0|-0.98|-0.53||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, and the interaction of time by treatment.|cLDA Model|||||-0.53|-0.98|<0.001
70897043|NCT01986881|141282122|SUPERIORITY||Difference in the Least Squares Means|-0.66|||<|0.001|TWO_SIDED|95.0|-0.89|-0.43||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, and the interaction of time by treatment.|cLDA model|||||-0.43|-0.89|<0.001
70897044|NCT01986881|141282123|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.108|TWO_SIDED|95.8|0.75|1.034|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.034|0.750|0.108
70897045|NCT01986881|141282123|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.15|TWO_SIDED|95.8|0.725|1.057|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.057|0.725|0.150
70897046|NCT01986881|141282123|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.188|TWO_SIDED|95.8|0.735|1.068|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.068|0.735|0.188
70897047|NCT01986881|141282124|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.385|TWO_SIDED|95.8|0.767|1.113|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.113|0.767|0.385
70897048|NCT01986881|141282124|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.417|TWO_SIDED|95.8|0.739|1.139|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.139|0.739|0.417
70897049|NCT01986881|141282124|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.494|TWO_SIDED|95.8|0.75|1.154|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.154|0.750|0.494
70897050|NCT01986881|141282125|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.081|TWO_SIDED|95.8|0.63|1.036|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.036|0.630|0.081
70897051|NCT01986881|141282125|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.258|TWO_SIDED|95.8|0.638|1.137|||Cox Proportional Hazard Model|"Model included treatment as an explanatory factor and cohort category as a stratification factor.~Renal"||||1.137|0.638|0.258
70897052|NCT01986881|141282125|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.065|TWO_SIDED|95.8|0.568|1.028|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.028|0.568|0.065
70897053|NCT01986881|141282126|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.183|TWO_SIDED|95.0|0.823|1.038||Hazard ratio, CI, and 2-sided p-value comparing All Ertugliflozin versus Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|Cox proportional hazards model|||||1.038|0.823|0.183
70897054|NCT01986881|141282126|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.45|TWO_SIDED|95.0|0.831|1.086|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.086|0.831|0.450
70897055|NCT01986881|141282126|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.123|TWO_SIDED|95.0|0.785|1.029|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.029|0.785|0.123
70897056|NCT01986881|141282127|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.676|TWO_SIDED|95.0|0.861|1.259|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.259|0.861|0.676
70897057|NCT01986881|141282127|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.139|TWO_SIDED|95.0|0.949|1.451|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.451|0.949|0.139
70897058|NCT01986881|141282127|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.416|TWO_SIDED|95.0|0.727|1.141|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.141|0.727|0.416
70897059|NCT01986881|141282128|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.663|TWO_SIDED|95.0|0.82|1.365||Hazard ratio, CI, and 2-sided p-value comparing All Ertugliflozin versus Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|Cox proportional hazards model||Hazard ratio, CI, and 2-sided p-value comparing All Ertugliflozin versus Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|||1.365|0.820|0.663
70897060|NCT01986881|141282128|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.415|TWO_SIDED|95.0|0.845|1.505||A two-sided p-value compared Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|Cox proportional hazards model|||Hazard ratio, confidence interval, and two-sided p-value comparing Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that includes treatment as an explanatory factor and cohort category as a stratification factor.||1.505|0.845|0.415
70897061|NCT01986881|141282128|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.953|TWO_SIDED|95.0|0.736|1.334||A two-sided p-value compared Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|Cox proportional hazards model|||Hazard ratio, confidence interval, and two-sided p-value comparing Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that includes treatment as an explanatory factor and cohort category as a stratification factor.||1.334|0.736|0.953
70897062|NCT01986881|141282129|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.006|TWO_SIDED|95.0|0.539|0.902||Hazard ratio, CI, and 2-sided p-value comparing All Ertugliflozin versus Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|Cox proportional hazards model|||||0.902|0.539|0.006
70897063|NCT01986881|141282129|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.016|TWO_SIDED|95.0|0.502|0.932|||Cox Proportional Hazards Model|Hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.||||0.932|0.502|0.016
70897064|NCT01986881|141282129|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.028|TWO_SIDED|95.0|0.524|0.964|||Cox Proportional Hazards Model|Hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.||||0.964|0.524|0.028
70897065|NCT01986881|141282130|SUPERIORITY|Hazard ratio, CI, and 2-sided p-value comparing Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date.|Hazard Ratio (HR)|0.93||||0.34|TWO_SIDED|95.0|0.797|1.081||Hazard ratio, CI, and 2-sided p-value comparing Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|Cox proportional hazards model|||||1.081|0.797|0.340
70897066|NCT01986881|141282130|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.463|TWO_SIDED|95.0|0.784|1.117|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.117|0.784|0.463
70897067|NCT01986881|141282130|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.363|TWO_SIDED|95.0|0.771|1.1|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.100|0.771|0.363
70897068|NCT01986881|141282131|SUPERIORITY|Ertugliflozin vs Placebo, based on the Andersen-Gill model for the recurrent events at the end of study. The on-study approach includes confirmed events that occurred between the randomization date and the on-study censor date.|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.898|1.131||||||||1.131|0.898|
70897069|NCT01986881|141282131|SUPERIORITY||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.937|1.219||||||||1.219|0.937|
70897070|NCT01986881|141282131|SUPERIORITY||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.828|1.085||||||||1.085|0.828|
70897071|NCT01986881|141282132|SUPERIORITY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.716|0.945||||||Ertugliflozin vs Placebo, based on the Andersen-Gill model for the recurrent events at the end of study. The on-study approach included confirmed events that occurred between randomization date and the on-study censor date.||0.945|0.716|
70897072|NCT01986881|141282132|SUPERIORITY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.673|0.935|||||Ertugliflozin vs Placebo, based on the Andersen-Gill model for the recurrent events at the end of study.|||0.935|0.673|
70897073|NCT01986881|141282132|SUPERIORITY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.725|1.001|||||Ertugliflozin vs Placebo, based on the Andersen-Gill model for the recurrent events at the end of study.|||1.001|0.725|
70897074|NCT01986881|141282133|SUPERIORITY||Difference in the Least Squares Means|-0.5|||<|0.001|TWO_SIDED|95.0|-0.55|-0.46|||cLDA Model|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.46|-0.55|<0.001
70897075|NCT01986881|141282133|SUPERIORITY||Difference in the Least Squares Means|-0.48|||<|0.001|TWO_SIDED|95.0|-0.53|-0.44|||cLDA model|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.44|-0.53|<0.001
70897076|NCT01986881|141282134|SUPERIORITY||Difference in the Least Squares Means|-0.48|||<|0.001|TWO_SIDED|95.0|-0.54|-0.43|||Constrained Longitudinal Data Analysis|Model included fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.43|-0.54|<0.001
70897077|NCT01986881|141282134|SUPERIORITY||Difference in the Least Squares Means|-0.5|||<|0.001|TWO_SIDED|95.0|-0.55|-0.45|||Constrained Longitudinal Data Analysis|Model included fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.45|-0.55|<0.001
70897078|NCT01986881|141282135|SUPERIORITY||Difference in the least squares means|-0.37|||<|0.001|TWO_SIDED|95.0|-0.45|-0.3||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis||Ertugliflozin vs. Placebo|||-0.30|-0.45|<0.001
70897079|NCT01986881|141282135|SUPERIORITY||Difference in Least Squares Means|-0.39|||<|0.001|TWO_SIDED|95.0|-0.46|-0.32||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA|Ertugliflozin vs. Placebo.||||-0.32|-0.46|<0.001
70897080|NCT01986881|141282137|SUPERIORITY||Difference in the least squares means|-0.31||||0.001|TWO_SIDED|95.0|-0.41|-0.21||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA|||||-0.21|-0.41|0.001
70897081|NCT01986881|141282137|SUPERIORITY||Difference in the least squares means|-0.36|||<|0.001|TWO_SIDED|95.0|-0.46|-0.26||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA model|||||-0.26|-0.46|<0.001
70897082|NCT01986881|141282152|SUPERIORITY||Difference in the Least Squares Means|-17.56|||<|0.001|TWO_SIDED|95.0|-19.49|-15.63|||CLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||-15.63|-19.49|<0.001
70897083|NCT01986881|141282152|SUPERIORITY||Difference in the Least Squares Means|-15.1|||<|0.001|TWO_SIDED|95.0|-17.03|-13.17|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||-13.17|-17.03|<0.001
70897084|NCT01986881|141282159|SUPERIORITY||||||<|0.001|||||||Log Rank|Log-Rank Test for the comparison to Placebo was based on all data (including for those participants who never had the event).||||||<0.001
70897085|NCT01986881|141282159|SUPERIORITY||||||<|0.001|||||||Log Rank|Log-Rank Test for the comparison to Placebo was based on all data (including for those participants who never had the event).||||||<0.001
70897086|NCT01986881|141282160|SUPERIORITY||||||<|0.001|||||||Log Rank|Log-Rank Test for the comparison to Placebo was based on all data (including for those participants who never had the event).||||||<0.001
70897087|NCT01986881|141282160|SUPERIORITY||||||<|0.001|||||||Log Rank|Log-Rank Test for the comparison to Placebo was based on all data (including for those participants who never had the event).||||||<0.001
70897088|NCT01986881|141282168|SUPERIORITY||Difference in the Least Squares Means|-2.78|||<|0.001|TWO_SIDED|95.0|-3.45|-2.1|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-2.10|-3.45|<0.001
70897089|NCT01986881|141282168|SUPERIORITY||Difference in the Least Squares Means|-2.53|||<|0.001|TWO_SIDED|95.0|-3.21|-1.86|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.86|-3.21|<0.001
70897090|NCT01986881|141282169|SUPERIORITY||Difference in the Least Squares Mean|-3.15|||<|0.001|TWO_SIDED|95.0|-3.85|-2.45|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-2.45|-3.85|<0.001
70897091|NCT01986881|141282169|SUPERIORITY||Difference in the Least Squares Means|-2.58|||<|0.001|TWO_SIDED|95.0|-3.28|-1.89|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.89|-3.28|<0.001
70897092|NCT01986881|141282170|SUPERIORITY||Difference in the Least Squares Means|-2.72|||<|0.001|TWO_SIDED|95.0|-3.57|-1.86|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.86|-3.57|<0.001
70897093|NCT01986881|141282170|SUPERIORITY||Difference in the Least Squares Means|-2.7|||<|0.001|TWO_SIDED|95.0|-3.56|-1.85|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.85|-3.56|<0.001
70897094|NCT01986881|141282172|SUPERIORITY||Difference in the Least Squares Means|-2.6|||<|0.001|TWO_SIDED|95.0|-3.68|-1.52|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.52|-3.68|<0.001
70897095|NCT01986881|141282172|SUPERIORITY||Difference in the Least Squares Means|-2.79|||<|0.001|TWO_SIDED|95.0|-3.87|-1.71|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.71|-3.87|<0.001
70897096|NCT01986881|141282175|SUPERIORITY||Difference in the Least Squares Means|-0.96|||<|0.001|TWO_SIDED|95.0|-1.37|-0.56|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.56|-1.37|<0.001
70897097|NCT01986881|141282175|SUPERIORITY||Difference in the Least Means Squares|-0.87|||<|0.001|TWO_SIDED|95.0|-1.28|-0.47|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.47|-1.28|<0.001
70897098|NCT01986881|141282176|SUPERIORITY||Difference in the Least Squares Means|-0.81|||<|0.001|TWO_SIDED|95.0|-1.22|-0.39|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.39|-1.22|<0.001
70897099|NCT01986881|141282176|SUPERIORITY||Difference in the Least Squares Means|-0.83|||<|0.001|TWO_SIDED|95.0|-1.24|-0.41|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.41|-1.24|<0.001
70897100|NCT01986881|141282177|SUPERIORITY||Difference in the Least Squares Means|-0.67||||0.01|TWO_SIDED|95.0|-1.19|-0.16|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.16|-1.19|0.010
70897101|NCT01986881|141282177|SUPERIORITY||Difference in the Least Squares Means|-0.71||||0.006|TWO_SIDED|95.0|-1.22|-0.2|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.20|-1.22|0.006
70897102|NCT01986881|141282179|SUPERIORITY||Difference in the least squares means|-0.78||||0.024|TWO_SIDED|95.0|-1.46|-0.1||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.10|-1.46|0.024
70897103|NCT01986881|141282179|SUPERIORITY||Difference in the least squares means|-0.81||||0.02|TWO_SIDED|95.0|-1.48|-0.13||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.13|-1.48|0.020
70897104|NCT01986881|141282182|SUPERIORITY||Difference in the Least Squares Means|-1.92|||<|0.001|TWO_SIDED|95.0|-2.07|-1.77|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.77|-2.07|<0.001
70897105|NCT01986881|141282182|SUPERIORITY||Difference in the Least Squares Means|-1.63|||<|0.001|TWO_SIDED|95.0|-1.78|-1.47|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.47|-1.78|<0.001
70897106|NCT01986881|141282183|SUPERIORITY||Difference in the Least Squares Means|-2.45|||<|0.001|TWO_SIDED|95.0|-2.67|-2.24|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-2.24|-2.67|<0.001
70897107|NCT01986881|141282183|SUPERIORITY||Difference in the Least Squares Means|-2.07|||<|0.001|TWO_SIDED|95.0|-2.28|-1.86|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.86|-2.28|<0.001
70897108|NCT01986881|141282184|SUPERIORITY||Difference in the Least Squares Means|-2.53|||<|0.001|TWO_SIDED|95.0|-2.83|-2.22|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-2.22|-2.83|<0.001
70897109|NCT01986881|141282184|SUPERIORITY||Difference in the Least Squares Means|-2.11|||<|0.001|TWO_SIDED|95.0|-2.39|-1.83|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.83|-2.39|<0.001
70897110|NCT01986881|141282186|SUPERIORITY||Difference in the Least Squares Means|-2.53|||<|0.001|TWO_SIDED|95.0|-2.97|-2.1|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-2.10|-2.97|<0.001
70897111|NCT01986881|141282186|SUPERIORITY||Difference in the Least Squares Means|-2.1|||<|0.001|TWO_SIDED|95.0|-2.52|-1.68|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.68|-2.52|<0.001
70897112|NCT01986881|141282189|SUPERIORITY||Difference in the Lease Squares Means|-1.78|||||TWO_SIDED|95.0|-2.41|-1.15|||||||Based on cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|-1.15|-2.41|
70897113|NCT01986881|141282189|SUPERIORITY||Difference in the Least Squares Means|-1.19|||||TWO_SIDED|95.0|-1.82|-0.56|||||||Based on cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|-0.56|-1.82|
70897114|NCT01986881|141282190|SUPERIORITY||Difference in the Lease Squares Means|-0.88|||||TWO_SIDED|95.0|-1.58|-0.18|||||||Based on cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|-0.18|-1.58|
70897115|NCT01986881|141282190|SUPERIORITY||Difference in the Least Squares Means|-0.21|||||TWO_SIDED|95.0|-0.91|0.49|||||||Based on cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|0.49|-0.91|
70897116|NCT01986881|141282191|SUPERIORITY||Difference in the least squares means|0.25|||||TWO_SIDED|95.0|-0.59|1.08|||||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|||1.08|-0.59|
70897117|NCT01986881|141282191|SUPERIORITY||Difference in the least squares means|1.12|||||TWO_SIDED|95.0|0.28|1.95|||||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|||1.95|0.28|
70897118|NCT01986881|141282193|SUPERIORITY||Difference in the Lease Squares Means|1.48|||||TWO_SIDED|95.0|0.31|2.66|||||||Based on cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|2.66|0.31|
70897119|NCT01986881|141282193|SUPERIORITY||Difference in the Least Squares Means|1.66|||||TWO_SIDED|95.0|0.49|2.84|||||||Based on cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|2.84|0.49|
70897120|NCT01986881|141282217|SUPERIORITY||Difference in % vs Placebo|-0.9|||||TWO_SIDED|95.0|-2.8|0.9|||||||Miettinen \& Nurminen method|0.9|-2.8|
70897121|NCT01986881|141282217|SUPERIORITY||Difference in % vs Placebo|0.3|||||TWO_SIDED|95.0|-1.6|2.1|||||||Miettinen \& Nurminen method|2.1|-1.6|
70897122|NCT01986881|141282218|SUPERIORITY||Difference in % vs Placebo|1.3|||||TWO_SIDED|95.0|-5.8|8.4|||||||Miettinen \& Nurminen method|8.4|-5.8|
70897123|NCT01986881|141282218|SUPERIORITY||Difference in % vs Placebo|-1.9|||||TWO_SIDED|95.0|-9.2|5.4|||||||Miettinen \& Nurminen method|5.4|-9.2|
70897124|NCT01986881|141282219|SUPERIORITY||Difference in % vs Placebo|1.4|||||TWO_SIDED|95.0|-17.7|20.4|||||||Miettinen and Nurminen method|20.4|-17.7|
70897125|NCT01986881|141282219|SUPERIORITY||Difference in % vs Placebo|-19.9|||||TWO_SIDED|95.0|-37.5|-1.2|||||||Miettinen and Nurminen method|-1.2|-37.5|
70897126|NCT01986881|141282220|SUPERIORITY||Difference in % vs Placebo|7.9|||||TWO_SIDED|95.0|-5.1|20.5|||||||Based on Miettinen and Nurminen method|20.5|-5.1|
70897127|NCT01986881|141282220|SUPERIORITY||Difference in % vs Placebo|1.0|||||TWO_SIDED|95.0|-12.3|14.2|||||||Miettinen and Nurminen method|14.2|-12.3|
70897128|NCT01986881|141282222|SUPERIORITY||Difference in % vs Placebo|0.0|||||TWO_SIDED|95.0|-2.9|3.0|||||||Miettinen \& Nurminen method|3.0|-2.9|
70897129|NCT01986881|141282222|SUPERIORITY||Difference in % vs Placebo|-1.2|||||TWO_SIDED|95.0|-4.0|1.6|||||||Miettinen \& Nurminen method|1.6|-4.0|
70897130|NCT01986881|141282225|SUPERIORITY||Difference in the Least Squares Means|-25.4|||<|0.001|TWO_SIDED|95.0|-32.84|-17.96|||CLDA|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin) and the interaction of time by treatment.||||-17.96|-32.84|<0.001
70897131|NCT01986881|141282225|SUPERIORITY||Difference in the Least Squares Means|-19.24|||<|0.001|TWO_SIDED|95.0|-26.8|-11.68|||cLDA|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin) and the interaction of time by treatment.||||-11.68|-26.80|<0.001
70897132|NCT01986881|141282226|SUPERIORITY||Difference in the Least Squares Means|-1.88|||<|0.001|TWO_SIDED|95.0|-2.37|-1.13|||cLDA|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin) and the interaction of time by treatment.||||-1.13|-2.37|<0.001
70897133|NCT01986881|141282226|SUPERIORITY||Difference in the Least Squares Means|-1.62|||<|0.001|TWO_SIDED|95.0|-2.12|-1.13|||cLDA model|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin) and the interaction of time by treatment.||||-1.13|-2.12|<0.001
70897134|NCT01986881|141282227|SUPERIORITY||Adjusted Odds Ratio Relative to Placebo|2.49|||<|0.001|TWO_SIDED|95.0|1.61|3.83|||Regression, Logistic|Model fitted with fixed effects for treatment, stratum for insulin sub-study, covariates for baseline A1C and baseline eGFR (continuous).||Missing data imputed using the Constrained Longitudinal Data Analysis (cLDA) model fitted with fixed effects as in the primary analysis.||3.83|1.61|<0.001
70897135|NCT01986881|141282227|SUPERIORITY||Adjusted Odds Ratio Relative to Placebo|2.6|||<|0.001|TWO_SIDED|95.0|1.64|4.12|||Regression, Logistic|Model fitted with fixed effects for treatment, stratum for insulin sub-study, covariates for baseline A1C and baseline eGFR (continuous).||Missing data imputed using the Constrained Longitudinal Data Analysis (cLDA) model fitted with fixed effects as in the primary analysis.||4.12|1.64|<0.001
70897136|NCT01986881|141282228|SUPERIORITY||Difference in the Least Squares Means|-2.32||||0.025|TWO_SIDED|95.0|-4.35|-0.3|||cLDA|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.||||-0.30|-4.35|0.025
70897137|NCT01986881|141282228|SUPERIORITY||Difference in the Least Squares Means|-2.88||||0.006|TWO_SIDED|95.0|-4.94|-0.82|||cLDA|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.||||-0.82|-4.94|0.006
70897138|NCT01986881|141282229|SUPERIORITY||Difference in the Least Squares Means|-0.38||||0.533|TWO_SIDED|95.0|-1.56|0.81|||cLDA model|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.||||0.81|-1.56|0.533
70897139|NCT01986881|141282229|SUPERIORITY||Difference in the Least Squares Means|-0.6||||0.326|TWO_SIDED|95.0|-1.81|0.6|||cLDA model|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.||||0.60|-1.81|0.326
70897140|NCT01986881|141282232|SUPERIORITY||Difference in the Least Squares Means|-12.22||||0.105|TWO_SIDED|95.0|-27.03|2.06|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||2.06|-27.03|0.105
70897141|NCT01986881|141282232|SUPERIORITY||Difference in the Least Squares Means|-13.53||||0.068|TWO_SIDED|95.0|-28.06|1.0|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||1.00|-28.06|0.068
70897142|NCT01986881|141282233|SUPERIORITY||Difference in the Least Squares Means|-0.52||||0.418|TWO_SIDED|95.0|-1.79|0.75|||cLDA|Model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||0.75|-1.79|0.418
70897143|NCT01986881|141282233|SUPERIORITY||Difference in the Least Squares Means|-1.07||||0.092|TWO_SIDED|95.0|-2.32|0.18|||cLDA model|Model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||0.18|-2.32|0.092
70897144|NCT01986881|141282234|SUPERIORITY||Odds ratio relative to placebo|1.48||||0.46|TWO_SIDED|95.0|0.52|4.17|||Regression, Logistic|Model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR (continuous).||Missing data imputed using the Constrained Longitudinal Data Analysis (cLDA) model fitted with fixed effects as in the primary analysis.||4.17|0.52|0.460
70897145|NCT01986881|141282234|SUPERIORITY||Odds ratio relative to placebo|1.62||||0.335|TWO_SIDED|95.0|0.61|4.35|||Regression, Logistic|Model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR (continuous).||Missing data imputed using the Constrained Longitudinal Data Analysis (cLDA) model fitted with fixed effects as in the primary analysis.||4.35|0.61|0.335
70897146|NCT01986881|141282235|SUPERIORITY||Difference in the Least Squares Means|2.73||||0.255|TWO_SIDED|95.0|-2.0|7.45|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||7.45|-2.00|0.255
70897147|NCT01986881|141282235|SUPERIORITY||Difference in the Least Squares Means|2.81||||0.235|TWO_SIDED|95.0|-1.85|7.48|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||7.48|-1.85|0.235
70897148|NCT01986881|141282236|SUPERIORITY||Difference in the Least Squares Means|1.98||||0.178|TWO_SIDED|95.0|-0.91|4.86|||cLDA model|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.||||4.86|-0.91|0.178
70897149|NCT01986881|141282236|SUPERIORITY||Difference in the Least Squares Means|1.73||||0.23|TWO_SIDED|95.0|-1.11|4.58|||cLDA|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.||||4.58|-1.11|0.230
70897150|NCT01986881|141282237|SUPERIORITY||Difference in the Least Squares Means|-31.37|||<|0.001|TWO_SIDED|95.0|-40.68|-22.07|||CLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||-22.07|-40.68|<0.001
70897151|NCT01986881|141282237|SUPERIORITY||Difference in the Least Squares Means|-30.47|||<|0.001|TWO_SIDED|95.0|-40.23|-20.72|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||-20.72|-40.23|<0.001
70897152|NCT01986881|141282238|SUPERIORITY||Difference in the Least Squares Means|-1.94|||<|0.001|TWO_SIDED|95.0|-2.65|-1.24|||cLDA|Model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||-1.24|-2.65|<0.001
70897153|NCT01986881|141282238|SUPERIORITY||Difference in the Least Squares Means|-1.57|||<|0.001|TWO_SIDED|95.0|-2.3|-0.84|||cLDA|Model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||-0.84|-2.30|<0.001
70897154|NCT01986881|141282239|SUPERIORITY||Adjusted odds ratio relative to placebo|4.1|||<|0.001|TWO_SIDED|95.0|2.0|8.42|||Regression, Logistic|Model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR (continuous).||Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.||8.42|2.00|<0.001
70897155|NCT01986881|141282239|SUPERIORITY||Adjusted odds ratio relative to placebo|5.97|||<|0.001|TWO_SIDED|95.0|2.86|12.49|||Regression, Logistic|Model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR (continuous).||Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.||12.49|2.86|<0.001
70897156|NCT01986881|141282240|SUPERIORITY||Difference in the Least Squares Means|-0.85||||0.597|TWO_SIDED|95.0|-4.0|2.3|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||2.30|-4.00|0.597
70897157|NCT01986881|141282240|SUPERIORITY||Difference in the Least Squares Means|-1.57||||0.351|TWO_SIDED|95.0|-4.87|1.73|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||1.73|-4.87|0.351
70897158|NCT01986881|141282241|SUPERIORITY||Difference in the Least Squares Means|-0.68||||0.49|TWO_SIDED|95.0|-2.6|1.25|||cLDA|Model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||1.25|-2.60|0.490
70897159|NCT01986881|141282241|SUPERIORITY||Difference in the Least Squares Means|-0.05||||0.958|TWO_SIDED|95.0|-2.07|1.96|||cLDA|Model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||1.96|-2.07|0.958
70897160|NCT04333420|141282242|SUPERIORITY||LS means difference|-16.4||||0.3677|TWO_SIDED|95.0|-53.2|20.3|||Linear repeated measures model|||||20.3|-53.2|0.3677
70897161|NCT04333420|141282243|SUPERIORITY||Hazard Ratio (HR)|0.728||||0.0941|TWO_SIDED|95.0|0.502|1.056|||Regression, Cox|including stratification by site||Cox proportional hazards regression model with outcome 28-day all-cause mortality (censored time to event variable with event = Death) including stratification by site; 61 patients from sites with no events (no death) or from single patient sites with death factually make no contribution to the analysis outcome.||1.056|0.502|0.0941
70897162|NCT04333420|141282243|SUPERIORITY||Hazard Ratio (HR)|0.674||||0.0266|TWO_SIDED|95.0|0.476|0.955|||Regression, Cox|Without stratification by site||Cox proportional hazards regression model with outcome 28-day all-cause mortality (censored time to event variable with event = Death) without stratification by site; Post-hoc analysis||0.955|0.476|0.0266
70897163|NCT04333420|141282243|SUPERIORITY||Hazard Ratio (HR)|0.648||||0.0181|TWO_SIDED|95.0|0.453|0.929|||Regression, Cox|Including random effect for site (frailty model)||Cox proportional hazards regression model with outcome 28-day all-cause mortality (censored time to event variable with event = Death) including random effect for site (frailty model); Post-hoc analysis||0.929|0.453|0.0181
70897164|NCT04333420|141282243|SUPERIORITY||Hazard Ratio (HR)|0.613||||0.0067|TWO_SIDED|95.0|0.43|0.873|||Regression, Cox|Including stratification by country||Cox proportional hazards regression model with outcome 28-day all-cause mortality (censored time to event variable with event = Death) including stratification by country; Post-hoc analysis||0.873|0.430|0.0067
70897165|NCT04333420|141282243|SUPERIORITY||Risk Difference (RD)|-11.0||||0.0293|TWO_SIDED|95.0|-20.8|-1.2|||Regression, Logistic|Multiple imputation of missing values|Risk difference and lower/upper limit of the Confidence Interval are given in percent|Sensitivity analysis; 369 patients were included in this analysis including the patient that was randomized in error and not treated. Missing values were imputed by multiple imputation.||-1.2|-20.8|0.0293
70897166|NCT04333420|141282243|SUPERIORITY|||||||0.0407|||||||Log Rank|||Post-hoc analysis||||0.0407
70897167|NCT04333420|141282244|SUPERIORITY||Hazard Ratio (HR)|0.651||||0.6494|TWO_SIDED|95.0|0.103|4.135|||Regression, Cox|Covariate: Treatment (IFX-1 + BSC)||Cox proportional hazards regression model with outcome 28-day all-cause mortality (censored time to event variable with event = Death)||4.135|0.103|0.6494
70897168|NCT04333420|141282248|SUPERIORITY||Hazard Ratio (HR)|0.735||||0.0815|TWO_SIDED|95.0|0.519|1.039|||Regression, Cox|||Cox proportional hazards regression model with outcome 60-day all-cause mortality (censored time to event variable with event = Death); Covariate: Treatment (IFX-1 + SOC)||1.039|0.519|0.0815
70897169|NCT04333420|141282249|SUPERIORITY||Risk Difference (RD)|7.352||||0.1553|TWO_SIDED|95.0|-2.762|17.465|||Regression, Logistic||Risk difference (IFX-1 - Placebo) of percentage of patients with an improvement in the 8-point ordinal scale; Risk difference and lower/upper limit of the CI are given in percent|At Day 15||17.465|-2.762|0.1553
70897170|NCT04333420|141282249|SUPERIORITY||Risk Difference (RD)|8.078||||0.1181|TWO_SIDED|95.0|-1.968|18.125|||Regression, Logistic||Risk difference (IFX-1 - Placebo) of percentage of patients with an improvement in the 8-point ordinal scale; Risk difference and lower/upper limit of the CI are given in percent|At Day 28||18.125|-1.968|0.1181
70897171|NCT04333420|141282250|SUPERIORITY||Risk Difference (RD)|-2.081||||0.4105|TWO_SIDED|95.0|-6.949|2.787|||Regression, Logistic||Risk difference (IFX-1 - Placebo) of percentage of patients developing acute kidney failure; Risk difference and lower/upper limit of the CI are given in percent|||2.787|-6.949|0.4105
70897172|NCT04333420|141282251|SUPERIORITY||Hazard Ratio (HR)|0.539||||0.0422|TWO_SIDED|95.0|0.297|0.978||p-value refers to hazard ratio from cause-specific Cox proportional hazards model for first renal replacement therapy.|Regression, Cox|Covariate: Treatment (IFX-1 + SOC)||||0.978|0.297|0.0422
70897173|NCT04179175|141282252|OTHER||Hazard Ratio (HR)|0.87||||0.25|TWO_SIDED|95.0|0.59|1.29|||Log Rank|one-sided stratified log-rank test, with region and body weight (\<90 kg, ≥ 90 kg) as strata||||1.29|0.59|0.250
70897174|NCT04179175|141282252|OTHER||Hazard Ratio (HR)|0.7||||0.044|TWO_SIDED|95.0|0.47|1.05|||Log Rank|one-sided stratified log-rank test, with region and body weight (\<90 kg, ≥ 90 kg) as strata||||1.05|0.47|0.044
70897175|NCT04149925|141282261|SUPERIORITY|||||||0.01||||||Significant when p\<0.05|t-test, 2 sided|||||||0.01
70897176|NCT03014674|141282274|EQUIVALENCE|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% confidence interval (CI) for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for Cmax.|Ratio|1.04|||||TWO_SIDED|90.0|0.98|1.11|||||Ratio (autoinjector/lyophilized drug) for Cmax has been presented|||1.11|0.98|
70897177|NCT03014674|141282274|EQUIVALENCE|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for Cmax.|Ratio|1.06|||||TWO_SIDED|90.0|0.99|1.12|||||Ratio (safety syringe/lyophilized drug) for Cmax has been presented|||1.12|0.99|
70897178|NCT03014674|141282275|EQUIVALENCE|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for AUC (0-t)|Ratio|1.08|||||TWO_SIDED|90.0|1.01|1.15|||||Ratio (autoinjector/lyophilized drug) for AUC(0-t) has been presented|||1.15|1.01|
70897179|NCT03014674|141282275|EQUIVALENCE|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for AUC (0-t).|Ratio|1.04|||||TWO_SIDED|90.0|0.97|1.12|||||Ratio (safety syringe/lyophilized drug) for AUC(0-t) has been presented|||1.12|0.97|
70897180|NCT03014674|141282275|EQUIVALENCE|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for AUC (0-inf).|Ratio|1.07|||||TWO_SIDED|90.0|1.0|1.13|||||Ratio (autoinjector/lyophilized drug) for AUC(0-inf) has been presented|||1.13|1.00|
70897181|NCT03014674|141282275|EQUIVALENCE|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for AUC (0-inf).|Ratio|1.02|||||TWO_SIDED|90.0|0.95|1.09|||||Ratio (safety syringe/lyophilized drug) for AUC(0-inf) has been presented|||1.09|0.95|
70897182|NCT04250727|141282297|SUPERIORITY|||||||0.601|||||||Wilcoxon (Mann-Whitney)|||||||0.601
70897183|NCT00833560|141282372|SUPERIORITY_OR_OTHER||Percentage of participants with response|85.4|||<|0.0001|TWO_SIDED|95.0|81.5|88.8|||Two - sided binomial test|||||88.8|81.5|<0.0001
70897184|NCT00833560|141282373|SUPERIORITY_OR_OTHER||Percentage of participants with response|87.7|||<|0.0001|TWO_SIDED|95.0|83.6|91.0|||Two-sided binomial test|||||91.0|83.6|<0.0001
70897185|NCT00677833|141282386|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95 percent (%) confidence interval (CI) for the difference in ACPR (PCR corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR (PCR-corrected) proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. The drug (AZ-CQ) was considered non-inferior with respect to this primary endpoint if the lower bound of this 95% CI was \>= -10% points.|ACPR percent difference|-9.1|||||TWO_SIDED|95.0|-16.02|-2.18|||Kaplan-Meier curves|||Null hypothesis: proportion of participants with ACPR (PCR-corrected) of Azithromycin/Chloroquine (AZ-CQ) at Day 28 is less than that of Artemether/Lumefantrine (AL); Alternative hypothesis: proportion of participants with ACPR (PCR-corrected) of AZ-CQ at Day 28 is greater than or equal (non-inferior) to that of AL by a non-inferiority margin of -0.1.||-2.18|-16.02|
70897186|NCT00677833|141282387|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR (PCR-corrected) proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. The drug (AZ-CQ) was considered non-inferior with respect to this primary endpoint if the lower bound of this 95% CI was \>= -10% points.|ACPR percent difference|-6.08|||||TWO_SIDED|95.0|-12.1|-0.05|||Kaplan-Meier curves|||Null hypothesis: proportion of participants with ACPR (PCR-corrected) of AZ-CQ at Day 28 is less than that of AL; Alternative hypothesis: proportion of participants with ACPR (PCR-corrected) of AZ-CQ at Day 28 is greater than or equal (non-inferior) to that of AL by a non-inferiority margin of -0.1.||-0.05|-12.10|
70897187|NCT00677833|141282388|SUPERIORITY_OR_OTHER||ACPR percent difference|-5.04|||||TWO_SIDED|95.0|-9.93|-0.15|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 7.||-0.15|-9.93|
70897188|NCT00677833|141282388|SUPERIORITY_OR_OTHER||ACPR percent difference|-6.74|||||TWO_SIDED|95.0|-12.15|-1.32|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 14.||-1.32|-12.15|
70897189|NCT00677833|141282388|SUPERIORITY_OR_OTHER||ACPR percent difference|-6.78|||||TWO_SIDED|95.0|-12.82|-0.75|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 21.||-0.75|-12.82|
70897190|NCT00677833|141282388|SUPERIORITY_OR_OTHER||ACPR percent difference|-6.92|||||TWO_SIDED|95.0|-14.59|0.76|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 35.||0.76|-14.59|
70897191|NCT00677833|141282388|SUPERIORITY_OR_OTHER||ACPR percent difference|-8.63|||||TWO_SIDED|95.0|-17.08|-0.18|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 42.||-0.18|-17.08|
70897192|NCT00677833|141282389|SUPERIORITY_OR_OTHER||ACPR percent difference|-3.63|||||TWO_SIDED|95.0|-8.4|1.14|||Kaplan-Meier, curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 21.||1.14|-8.40|
70897193|NCT00677833|141282389|SUPERIORITY_OR_OTHER||ACPR percent difference|-3.87|||||TWO_SIDED|95.0|-10.79|3.04|||Kaplan-Meier, curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 35.||3.04|-10.79|
70897194|NCT00677833|141282389|SUPERIORITY_OR_OTHER||ACPR percent difference|-5.66|||||TWO_SIDED|95.0|-13.55|2.22|||Kaplan-Meier, curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 42.||2.22|-13.55|
70897195|NCT00677833|141282390|SUPERIORITY_OR_OTHER||ACPR percent difference|-5.04|||||TWO_SIDED|95.0|-9.93|-0.15|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 7.||-0.15|-9.93|
70897196|NCT00677833|141282390|SUPERIORITY_OR_OTHER||ACPR percent difference|-7.71|||||TWO_SIDED|95.0|-14.54|-0.88|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 14.||-0.88|-14.54|
70897197|NCT00677833|141282390|SUPERIORITY_OR_OTHER||ACPR percent difference|-15.09|||||TWO_SIDED|95.0|-26.24|-3.94|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 21.||-3.94|-26.24|
70897198|NCT00677833|141282390|SUPERIORITY_OR_OTHER||ACPR percent difference|-21.76|||||TWO_SIDED|95.0|-34.14|-9.39|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 28.||-9.39|-34.14|
70897199|NCT00677833|141282390|SUPERIORITY_OR_OTHER||ACPR percent difference|-18.24|||||TWO_SIDED|95.0|-31.05|-5.43|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 35.||-5.43|-31.05|
70897200|NCT00677833|141282390|SUPERIORITY_OR_OTHER||ACPR Percent difference|-18.49|||||TWO_SIDED|95.0|-31.33|-5.65|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 42.||-5.65|-31.33|
70897201|NCT00677833|141282391|SUPERIORITY_OR_OTHER||ACPR percent difference|-4.67|||||TWO_SIDED|95.0|-10.6|1.25|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 14.||1.25|-10.60|
70897202|NCT00677833|141282391|SUPERIORITY_OR_OTHER||ACPR percent difference|-13.07|||||TWO_SIDED|95.0|-24.21|-1.92|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 21.||-1.92|-24.21|
70897203|NCT00677833|141282391|SUPERIORITY_OR_OTHER||ACPR percent difference|-19.62|||||TWO_SIDED|95.0|-32.16|-7.08|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 28.||-7.08|-32.16|
70897204|NCT00677833|141282391|SUPERIORITY_OR_OTHER||ACPR percent difference|-16.38|||||TWO_SIDED|95.0|-29.42|-3.33|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 35.||-3.33|-29.42|
70897205|NCT00677833|141282391|SUPERIORITY_OR_OTHER||ACPR Percent difference|-16.94|||||TWO_SIDED|95.0|-30.04|-3.83|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)- (AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the Greenwood formula. Estimates for Day 42.||-3.83|-30.04|
70897206|NCT00677833|141282398|SUPERIORITY_OR_OTHER||percent difference|-5.89|||||TWO_SIDED|95.0|-11.02|-0.75|||large sample approximation to binomial|||Day 7||-0.75|-11.02|
70897207|NCT00677833|141282398|SUPERIORITY_OR_OTHER||percent difference|-7.55|||||TWO_SIDED|95.0|-13.14|-1.95|||large sample approximation to binomial|||Day 14||-1.95|-13.14|
70897208|NCT00677833|141282398|SUPERIORITY_OR_OTHER||percent difference|-7.6|||||TWO_SIDED|95.0|-13.61|-1.6|||large sample approximation to binomial|||Day 21||-1.60|-13.61|
70897209|NCT00677833|141282398|SUPERIORITY_OR_OTHER||percent difference|-9.26|||||TWO_SIDED|95.0|-15.64|-2.87|||Large sample approximation to binomial|||Day 28||-2.87|-15.64|
70897210|NCT00677833|141282398|SUPERIORITY_OR_OTHER||percent difference|-7.71|||||TWO_SIDED|95.0|-14.45|-0.97|||Large sample approximation to binomial|||Day 35||-0.97|-14.45|
70897211|NCT00677833|141282398|SUPERIORITY_OR_OTHER||percent difference|-8.52|||||TWO_SIDED|95.0|-15.43|-1.6|||Large sample approximation to binomial|||Day 42||-1.60|-15.43|
70897212|NCT00677833|141282399|SUPERIORITY_OR_OTHER||percent difference|-9.51|||||TWO_SIDED|95.0|-18.27|-0.74|||Large sample approximation to binomial|||Day 7||-0.74|-18.27|
70897213|NCT00677833|141282399|SUPERIORITY_OR_OTHER||percent difference|-10.39|||||TWO_SIDED|95.0|-19.23|-1.55|||Large sample approximation to binomial|||Day 14||-1.55|-19.23|
70897214|NCT00677833|141282399|SUPERIORITY_OR_OTHER||percent difference|-12.75|||||TWO_SIDED|95.0|-21.45|-4.04|||Large sample approximation to binomial|||Day 21||-4.04|-21.45|
70897215|NCT00677833|141282399|SUPERIORITY_OR_OTHER||percent difference|-11.11|||||TWO_SIDED|95.0|-19.62|-2.6|||Large sample approximation to binomial|||Day 28||-2.60|-19.62|
70897216|NCT00677833|141282399|SUPERIORITY_OR_OTHER||percent difference|-10.34|||||TWO_SIDED|95.0|-18.97|-1.71|||Large sample approximation to binomial|||Day 35||-1.71|-18.97|
70897217|NCT00677833|141282399|SUPERIORITY_OR_OTHER||percent difference|-11.21|||||TWO_SIDED|95.0|-20.14|-2.28|||Large sample approximation to binomial|||Day 42||-2.28|-20.14|
70897218|NCT00677833|141282400|SUPERIORITY_OR_OTHER|||||||0.2564|TWO_SIDED||||||Kaplan-Meier, log rank|||Time to event data was analyzed using the Kaplan-Meier curve.||||0.2564
70897219|NCT00677833|141282401|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Kaplan-Meier, log rank|||Time to event data was analyzed using the Kaplan-Meier curve.||||<0.0001
70897220|NCT00677833|141282404|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||Kaplan-Meier, log rank|||Time to event data was analyzed using the Kaplan-Meier curve.||||0.0006
70897221|NCT05072457|141282407|OTHER||||||<|0.05|||||||ANOVA|||"MANOVA analysis with independent variable being the intervention condition (type of microphone used) and dependent variable being the performance on lateralization task.~Null hypothesis: There will be no statistically significant difference in lateralization test scores between the Roger On and the Roger Select in the experimental group."||||<.05
70897222|NCT05072457|141282408|OTHER||||||>|0.05|||||||ANOVA|||Independent variable: intervention condition (type of microphone used), Dependent variable: performance on spatial hearing task. Null hypothesis: There will be no statistically significant difference in spatial hearing test scores between the Roger On and the Roger Select in the experimental group.||||>.05
70897223|NCT00184548|141282411|SUPERIORITY_OR_OTHER|||||||0.934||||||Two-sided significance level 5%|Regression, Logistic|||Test for Odds ratio=1, corresponding to a null hypothesis of no difference in mortality for patients who died between groups for Blunt Trauma. Odds-ratio is adjusted for baseline covariates: Age, Injury Severity Score (ISS), Glasgow Coma -Scale Score (GCS), International Normalized Ratio (INR) and acute lung injury (P/F \> 200). Missing covariates are imputed by the mean value.||||0.934
70897224|NCT00184548|141282411|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.589||95.0|0.64|2.17||Two-sided significance level 5%|Cox Proportional Hazards Model|||Treatment groups are compared using a Cox Proportional Hazards model with treatment as factor and adjusting for age, Injury Severity Score (ISS), Glasgow Coma -Scale Score(GCS), International Normalized Ratio (INR) and acute lung injury.||2.17|0.64|0.589
70897225|NCT00184548|141282413|SUPERIORITY_OR_OTHER||LS means|0.9||||0.308||95.0|-0.83|2.63|||ANCOVA|||Baseline covariates: Age, Injury Severity Score (ISS), Glasgow Coma -Scale Score (GCS), International Normalized Ratio (INR) and acute lung injury.||2.63|-0.83|0.308
70897226|NCT00184548|141282415|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift estimate|1.0||||0.038||95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|0|0.038
70897227|NCT00184548|141282416|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.175||||0.384||95.0|0.817|1.69|||Regression, Logistic|||||1.690|0.817|0.384
70897228|NCT00184548|141282417|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift estimate|2.0||||0.03||95.0|0.0|4.0|||Wilcoxon (Mann-Whitney)|||||4|0|0.030
70897229|NCT02184611|141282437|OTHER||Least square mean difference|0.154|||<|0.001|TWO_SIDED|95.0|0.113|0.194||Analysis was performed using a MMRM model with covariates of treatment, Baseline, smoking status, country, Day, Day by Baseline and Day by treatment interactions.|Mixed Models Repeated Measures (MMRM)|||UMEC versus Placebo.||0.194|0.113|<0.001
70897230|NCT02184611|141282438|OTHER||Least square Mean difference|0.9||||0.004|TWO_SIDED|95.0|0.3|1.5||Analysis performed using a MMRM model with covariates of treatment, BDI focal score, smoking status, country, Day, Day by BDI focal score and Day by treatment interactions.|MMRM|||UMEC versus Placebo.||1.5|0.3|0.004
70897231|NCT02184611|141282439|OTHER||Least square Mean difference|0.125|||<|0.001|TWO_SIDED|95.0|0.103|0.147||Analysis performed using an analysis of covariance (ANCOVA) model with covariates of treatment, baseline (mean of the two assessments made 30 min and 5 min pre-dose on Day 1), smoking status and country.|ANCOVA|||UMEC versus Placebo.||0.147|0.103|<0.001
70897232|NCT02184611|141282448|OTHER||Least sqaure mean difference|-4.39||||0.002|TWO_SIDED|95.0|-7.21|-1.58||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 28, UMEC Vs Placebo.||-1.58|-7.21|0.002
70897233|NCT02184611|141282448|OTHER||Least square mean difference|-4.59||||0.003|TWO_SIDED|95.0|-7.61|-1.57||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 84, UMEC Vs Placebo.||-1.57|-7.61|0.003
70897234|NCT02184611|141282448|OTHER||Least sqaure mean difference|-3.03||||0.058|TWO_SIDED|95.0|-6.15|0.1||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 168, UMEC Vs Placebo.||0.10|-6.15|0.058
70897235|NCT02184611|141282449|OTHER||Least sqaure mean difference|-1.49||||0.027|TWO_SIDED|95.0|-2.81|-0.17||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 28, UMEC Vs Placebo.||-0.17|-2.81|0.027
70897236|NCT02184611|141282449|OTHER||Least square mean difference|-2.1||||0.004|TWO_SIDED|95.0|-3.51|-0.68||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 84, UMEC Vs Placebo.||-0.68|-3.51|0.004
70897237|NCT02184611|141282449|OTHER||Least square mean difference|-0.68||||0.386|TWO_SIDED|95.0|-2.22|0.86||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 128, UMEC Vs Placebo.||0.86|-2.22|0.386
70897238|NCT02623322|141282480|SUPERIORITY||Difference in event rates (Wald)|-3.03||||0.3031|TWO_SIDED|80.0|-12.25|6.19|||Cochran-Mantel-Haenszel|||||6.19|-12.25|0.3031
70897239|NCT02623322|141282480|SUPERIORITY||Difference in event rates (Wald)|-3.03||||0.3324|TWO_SIDED|80.0|-12.82|6.76|||Cochran-Mantel-Haenszel|||||6.76|-12.82|0.3324
70897240|NCT02623322|141282481|SUPERIORITY||Difference in event rates (Wald)|-3.03||||0.3031|TWO_SIDED|80.0|-12.25|6.19|||Cochran-Mantel-Haenszel|||||6.19|-12.25|0.3031
70897241|NCT02623322|141282481|SUPERIORITY||Difference in event rates (Wald)|-3.03||||0.3324|TWO_SIDED|80.0|-12.82|6.76|||Cochran-Mantel-Haenszel|||||6.76|-12.82|0.3324
70897242|NCT02623322|141282485|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.7858|TWO_SIDED|80.0|0.62|1.37|||Wilcoxon|||Total Symptom Score of \<=1||1.37|0.62|0.7858
70897243|NCT02623322|141282485|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.517|TWO_SIDED|80.0|0.59|1.36|||Wilcoxon|||Total Symptom Score of \<=1||1.36|0.59|0.5170
70897244|NCT02623322|141282485|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0312|TWO_SIDED|80.0|0.45|0.89|||Wilcoxon|||Total Symptom Score of \<=7||0.89|0.45|0.0312
70897245|NCT02623322|141282485|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.2044|TWO_SIDED|80.0|0.53|1.04|||Wilcoxon|||Total Symptom Score of \<=7||1.04|0.53|0.2044
70897246|NCT03563716|141282487|SUPERIORITY||Odds Ratio (OR)|2.57|||||TWO_SIDED|95.0|1.07|6.14|||||95% CI for odds ratio was constructed using the Wald method.|Stratified analysis based on PD-L1 immunohistochemistry (IHC) 22C3 pharmDx, tumor histology status, and tobacco history.||6.14|1.07|
70897247|NCT03563716|141282488|SUPERIORITY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.37|0.9|||||Hazard ratios were estimated by Cox regression.|Stratified analysis based on PD-L1 IHC 22C3 pharmDx, tumor histology status, and tobacco history.||0.90|0.37|
70897248|NCT03775200|141282495|OTHER|For this primary analysis, a sample size of 216 randomised participants (72:72:72) will provide 90% power at the alpha = 0.05 level to detect a 6-point difference in average MADRS total score between the optimal therapeutic dose of COMP360 and COMP360 1 mg, assuming the common standard deviation (SD) is 11.0.|Least Mean Square Difference|-6.6|STANDARD_ERROR_OF_MEAN|1.86|<|0.05|TWO_SIDED|95.0|-10.2|-2.9|||Mixed Models Analysis|Hypothetical strategy estimand - missing not at random (MNAR) and missing at random (MAR) imputation for missing data.|LSM difference of COMP360 25 mg compared to COMP360 1 mg.|The primary analysis was the comparison between COMP360 (25 mg or 10 mg) versus COMP360 1 mg. The null hypothesis was that there was no difference in mean change from Baseline in MADRS total score at Week 3 for COMP360 25 mg or COMP360 10 mg versus COMP360 1 mg. The alternative hypothesis was that were was a difference in mean change from Baseline in MADRS total score at Week 3 for COMP360 25 mg or COMP360 10 mg versus COMP360 1 mg.||-2.9|-10.2|<0.05
70897249|NCT03775200|141282496|OTHER||Least Mean Square Difference|-5.6|STANDARD_ERROR_OF_MEAN|1.93|<|0.05|TWO_SIDED|95.0|-9.4|-1.8|||Mixed Models Analysis|Hypothetical strategy estimand - MNAR and MAR imputation for missing data.||Sensitivity analysis of the primary endpoint using the per-protocol analysis set.||-1.8|-9.4|<0.05
70897250|NCT04605978|141282497|SUPERIORITY||Mean Difference (Net)|2.44|||||TWO_SIDED|95.0|-0.61|5.49|||||Missing data and data post intercurrent event were imputed for the statistical analysis as specified in the statistical analysis plan.|||5.49|-0.61|
70897251|NCT03813238|141282505|SUPERIORITY||LS mean difference|-1.2||||0.335|TWO_SIDED|95.0|-3.49|1.19|||Mixed Models Analysis|||The LS mean of the change in MDCRS part II total score from baseline to Week 15 was compared (TEV-50717 arm versus placebo) using a 1-sided test for superiority at a nominal significance level of α=0.025.||1.19|-3.49|0.335
70897252|NCT03318523|141282536|SUPERIORITY|Adjusted mean, difference with placebo, 95% confidence interval (CI), and p-value were based on a mixed model for repeated measures (MMRM) model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.3||||0.8976|TWO_SIDED|95.0|-4.888|4.287|||Mixed Model for Repeated Measures|||Change From Baseline in MDS-UPDRS Total Score at Week 52||4.287|-4.888|0.8976
70897253|NCT03318523|141282536|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.5||||0.796|TWO_SIDED|95.0|-3.31|4.312|||Mixed Model for Repeated Measures|||Change From Baseline in MDS-UPDRS Total Score at Week 52||4.312|-3.310|0.7960
70897254|NCT03318523|141282536|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.08||||0.9695|TWO_SIDED|95.0|-3.805|3.956|||Mixed Model for Repeated Measures|||Change From Baseline in MDS-UPDRS Total Score at Week 52||3.956|-3.805|0.9695
70897255|NCT03318523|141282537|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.28||||0.9093|TWO_SIDED|95.0|-5.035|4.483|||Mixed Model for Repeated Measures|||Change From Baseline in MDS-UPDRS Total Score at Week 72||4.483|-5.035|0.9093
70897256|NCT03318523|141282537|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|1.55||||0.4327|TWO_SIDED|95.0|-2.336|5.44|||Mixed Model for Repeated Measures|||Change From Baseline in MDS-UPDRS Total Score at Week 72||5.440|-2.336|0.4327
70897257|NCT03318523|141282537|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.17||||0.933|TWO_SIDED|95.0|-4.051|3.719|||Mixed Model with repeated Measures|||Change From Baseline in MDS-UPDRS Total Score at Week 72||3.719|-4.051|0.9330
70897258|NCT03318523|141282539|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.41||||0.8828|TWO_SIDED|95.0|-5.013|5.825|||Mixed Model for Repeated Measures|||||5.825|-5.013|0.8828
70897259|NCT03318523|141282539|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.84||||0.7019|TWO_SIDED|95.0|-3.458|5.128|||Mixed Model for Repeated Measure|||||5.128|-3.458|0.7019
70897260|NCT03318523|141282539|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.99||||0.6519|TWO_SIDED|95.0|-3.323|5.301|||Mixed Model for Repeated Measures|||||5.301|-3.323|0.6519
70897261|NCT03318523|141282541|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.53||||0.4327|TWO_SIDED|95.0|-1.851|0.794|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 52||0.794|-1.851|0.4327
70897262|NCT03318523|141282541|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.13||||0.8155|TWO_SIDED|95.0|-0.965|1.225|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 52||1.225|-0.965|0.8155
70897263|NCT03318523|141282541|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.22||||0.7015|TWO_SIDED|95.0|-0.899|1.334|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 52||1.334|-0.899|0.7015
70897264|NCT03318523|141282542|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-1.03||||0.1038|TWO_SIDED|95.0|-2.276|0.213|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 72||0.213|-2.276|0.1038
70897265|NCT03318523|141282542|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.09||||0.8689|TWO_SIDED|95.0|-0.933|1.103|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 72||1.103|-0.933|0.8689
70897266|NCT03318523|141282542|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.01||||0.982|TWO_SIDED|95.0|-1.026|1.003|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 72||1.003|-1.026|0.9820
70897267|NCT03318523|141282542|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.26||||0.693|TWO_SIDED|95.0|-1.563|1.04|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 96||1.040|-1.563|0.6930
70897268|NCT03318523|141282542|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.03||||0.9606|TWO_SIDED|95.0|-1.053|1.001|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 96||1.001|-1.053|0.9606
70897269|NCT03318523|141282542|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.24||||0.6512|TWO_SIDED|95.0|-1.269|0.794|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 96||0.794|-1.269|0.6512
70897270|NCT03318523|141282543|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.44||||0.5497|TWO_SIDED|95.0|-1.889|1.007|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 52||1.007|-1.889|0.5497
70897271|NCT03318523|141282543|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.0||||0.998|TWO_SIDED|95.0|-1.2|1.197|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 52||1.197|-1.200|0.9980
70897272|NCT03318523|141282543|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.15||||0.8069|TWO_SIDED|95.0|-1.374|1.07|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 52||1.070|-1.374|0.8069
70897273|NCT03318523|141282544|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.21||||0.7968|TWO_SIDED|95.0|-1.786|1.372|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 72||1.372|-1.786|0.7968
70897274|NCT03318523|141282544|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.53||||0.4211|TWO_SIDED|95.0|-0.766|1.827|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 72||1.827|-0.766|0.4211
70897275|NCT03318523|141282544|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.15||||0.8166|TWO_SIDED|95.0|-1.448|1.143|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 72||1.143|-1.448|0.8166
70897276|NCT03318523|141282544|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.53||||0.5535|TWO_SIDED|95.0|-2.31|1.24|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 96||1.240|-2.310|0.5535
70897277|NCT03318523|141282544|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.52||||0.4654|TWO_SIDED|95.0|-0.881|1.922|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 96||1.922|-0.881|0.4654
70897278|NCT03318523|141282544|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.36||||0.6184|TWO_SIDED|95.0|-1.051|1.763|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 96||1.763|-1.051|0.6184
70897279|NCT03318523|141282545|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.59||||0.7274|TWO_SIDED|95.0|-2.742|3.925|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 52||3.925|-2.742|0.7274
70897280|NCT03318523|141282545|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.66||||0.6385|TWO_SIDED|95.0|-2.094|3.411|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 52||3.411|-2.094|0.6385
70897281|NCT03318523|141282545|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.1||||0.9467|TWO_SIDED|95.0|-2.718|2.91|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 52||2.910|-2.718|0.9467
70897282|NCT03318523|141282546|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.85||||0.6112|TWO_SIDED|95.0|-2.423|4.114|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 72||4.114|-2.423|0.6112
70897283|NCT03318523|141282546|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.86||||0.527|TWO_SIDED|95.0|-1.806|3.52|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 72||3.520|-1.806|0.5270
70897284|NCT03318523|141282546|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.06||||0.9673|TWO_SIDED|95.0|-2.608|2.719|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 72||2.719|-2.608|0.9673
70897285|NCT03318523|141282546|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.65||||0.7455|TWO_SIDED|95.0|-3.274|4.569|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 96||4.569|-3.274|0.7455
70897286|NCT03318523|141282546|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.1||||0.9506|TWO_SIDED|95.0|-3.192|2.997|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 96||2.997|-3.192|0.9506
70897287|NCT03318523|141282546|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.69||||0.6643|TWO_SIDED|95.0|-2.422|3.794|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 96||3.794|-2.422|0.6643
70897288|NCT03318523|141282547|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.005||||0.8274|TWO_SIDED|95.0|-0.0548|0.0438|||Mixed Model for Repeated Measures|||||0.0438|-0.0548|0.8274
70897289|NCT03318523|141282547|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.009||||0.6671|TWO_SIDED|95.0|-0.0504|0.0323|||Mixed Model for Repeated Measures|||||0.0323|-0.0504|0.6671
70897290|NCT03318523|141282547|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.033||||0.1313|TWO_SIDED|95.0|-0.0751|0.0098|||Mixed Model for Repeated Measures|||||0.0098|-0.0751|0.1313
70897291|NCT03318523|141282548|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.009||||0.7079|TWO_SIDED|95.0|-0.0562|0.0382|||Mixed Model for Repeated Measures|||||0.0382|-0.0562|0.7079
70897292|NCT03318523|141282548|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|0.0||||0.9835|TWO_SIDED|95.0|-0.04|0.0392|||Mixed Model for Repeated Measures|||||0.0392|-0.0400|0.9835
70897293|NCT03318523|141282548|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.027||||0.1869|TWO_SIDED|95.0|-0.0682|0.0134|||Mixed Model for Repeated Measures|||||0.0134|-0.0682|0.1869
70897294|NCT03318523|141282549|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.008||||0.7585|TWO_SIDED|95.0|-0.0625|0.0456|||Mixed Model for Repeated Measures|||||0.0456|-0.0625|0.7585
70897295|NCT03318523|141282549|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|0.006||||0.7808|TWO_SIDED|95.0|-0.0391|0.052|||Mixed Model for Repeated Measures|||||0.0520|-0.0391|0.7808
70897296|NCT03318523|141282549|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.022||||0.3532|TWO_SIDED|95.0|-0.0691|0.0248|||Mixed Model for Repeated Measures|||||0.0248|-0.0691|0.3532
70897297|NCT03581981|141282551|SUPERIORITY|see statistical plan|Mean Difference (Final Values)|-3.6||||0.33|TWO_SIDED|95.0|-10.7|3.6|||Mixed Models Analysis|||||3.6|-10.7|0.33
70897298|NCT03581981|141282552|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.89|TWO_SIDED||||||Mixed Models Analysis|||||||0.89
70897299|NCT03581981|141282553|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.89|TWO_SIDED||||||Mixed Models Analysis|||||||0.89
70897300|NCT03581981|141282554|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.99|TWO_SIDED|95.0|-3.6|3.6|||Mixed Models Analysis|||||3.6|-3.6|0.99
70897301|NCT03581981|141282555|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.52|TWO_SIDED|95.0|-7.3|3.7|||Mixed Models Analysis|||||3.7|-7.3|0.52
70897302|NCT03581981|141282556|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.5|TWO_SIDED|95.0|-1.4|2.9|||Mixed Models Analysis|||||2.9|-1.4|0.50
70897303|NCT03581981|141282557|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED||||||Mixed Models Analysis|||||||0.99
70897304|NCT03581981|141282558|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED||||||Mixed Models Analysis|||||||0.99
70897305|NCT03581981|141282559|SUPERIORITY||Mean Difference (Final Values)|1.45||||0.69|TWO_SIDED||||||Mixed Models Analysis|||||||0.69
70897306|NCT03581981|141282560|SUPERIORITY||Mean Difference (Final Values)|1.45||||0.69|TWO_SIDED||||||Mixed Models Analysis|||||||0.69
70897307|NCT03581981|141282561|SUPERIORITY||Mean Difference (Final Values)|2.87||||0.41|TWO_SIDED||||||Mixed Models Analysis|||||||0.41
70897308|NCT03581981|141282562|SUPERIORITY||Mean Difference (Final Values)|2.87||||0.41|TWO_SIDED||||||Mixed Models Analysis|||||||0.41
70897309|NCT02080871|141282563|OTHER|This was a single-arm study designed to compare the primary outcome result to a performance goal based on published literature. The null hypothesis was the probability of a subject experiencing a Major Adverse Event (MAE) with use of study device is at least 17%. The alternate hypothesis was the probability of a subject experiencing a Major Adverse Event (MAE) with use of the study device is less than 17%.|||||<|0.001|||||||one-sided binomial exact test|||The sample size obtains over 90% power to statistically show the probability that a subject will experience an MAE with use of the study device is less than 17% when 12% or less of the subjects are lost to follow up prior to 9 months.||||<0.001
70897310|NCT02548455|141282694|EQUIVALENCE|Freedom from left ventricular lead-related complications through 3 months was estimated to be 96.0% with a 95% lower confidence bound of 92.6% based on the Promote Q IDE study (NCT00990665), and 98.3% with a 95% lower confidence bound of 97.7% based on data from the Quadripolar Post-Approval study (NCT01555619).|Kaplan-Meier Estimate|85.0||||0.05|TWO_SIDED||||||Log Rank|||"The hypothesis for the endpoint is:~H0: Freedom from LV lead-related complications through 3 months (91 days) ≤ 85% H1: Freedom from LV lead-related complications through 3 months (91 days) \> 85%~A total of 85 subjects were required to have at least 80% power to reject the null hypothesis at the 5% significance level at three months (91 days) post-implant or attempted implant. After accounting for 9% attrition, the required sample size was 94 subjects."||||0.05
70897311|NCT00831779|141282701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.97|STANDARD_ERROR_OF_MEAN|7.4685||0.0059|TWO_SIDED|95.0|5.75|36.1||Primary endpoint was tested at alpha=0.05|ANOVA|||||36.10|5.75|0.0059
70897312|NCT00831779|141282702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.13|STANDARD_ERROR_OF_MEAN|14.4984||0.0598|TWO_SIDED|95.0|-1.22|57.48||Secondary endpoint was tested following a sequential testing procedure at alpha=0.05|ANOVA|||||57.48|-1.22|0.0598
70897313|NCT02436330|141282703|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0615||||0.0967|TWO_SIDED|95.0|-0.1344|0.0115||We checked the distribution of bmiz changes between baseline and 6 months, and there is one subject from control group had bigger changes than others. After excluding this subject, the results are still similar with previous.|t-test, 2 sided|||||0.0115|-0.1344|0.0967
70897314|NCT02436330|141282704|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0775||||0.0335|TWO_SIDED|95.0|-0.1485|-0.00652|||t-test, 2 sided|||||-0.00652|-0.1485|0.0335
70897315|NCT02436330|141282705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.991|TWO_SIDED|95.0|-5.2|5.1|||t-test, 2 sided|||||5.1|-5.2|0.991
70897316|NCT02436330|141282706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0||||0.851|TWO_SIDED|95.0|-9.0|11.0|||t-test, 2 sided|||||11|-9|0.851
70897317|NCT02436330|141282707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9||||0.501|TWO_SIDED|95.0|-11.7|5.8|||t-test, 2 sided|||||5.8|-11.7|0.501
70897318|NCT02436330|141282708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2971||||0.035|TWO_SIDED|95.0|0.0224|0.5718|||t-test, 2 sided|||||0.5718|0.0224|0.035
70897319|NCT02436330|141282709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9464||||0.2207|TWO_SIDED|95.0|-2.4954|0.6025|||t-test, 2 sided|||||0.6025|-2.4954|0.2207
70897320|NCT02436330|141282710|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0491||||0.4164|TWO_SIDED|95.0|-3.6407|1.5425|||t-test, 2 sided|||||1.5425|-3.6407|0.4164
70897321|NCT02436330|141282711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2433.7||||0.812|TWO_SIDED|95.0|-18579.7|23447.2|||t-test, 2 sided|||||23447.2|-18579.7|0.812
70897322|NCT02436330|141282712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2837||||0.3326|TWO_SIDED|95.0|-0.3037|0.8711|||t-test, 2 sided|||||0.8711|-0.3037|0.3326
70897323|NCT02436330|141282713|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2995||||0.1856|TWO_SIDED|95.0|-0.2051|0.8041|||t-test, 2 sided|||||0.8041|-0.2051|0.1856
70897324|NCT02436330|141282714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-247.9||||0.0849|TWO_SIDED|95.0|-531.7|35.8686|||t-test, 2 sided|||||35.8686|-531.7|0.0849
70897325|NCT02436330|141282715|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.2048||||0.176|TWO_SIDED|95.0|-10.3835|1.974|||t-test, 2 sided|||||1.9740|-10.3835|0.176
70897326|NCT02436330|141282716|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.2151||||0.0247|TWO_SIDED|95.0|0.973|13.457|||t-test, 2 sided|||||13.457|0.973|0.0247
70897327|NCT02436330|141282717|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8169||||0.2764|TWO_SIDED|95.0|-2.4147|0.7808|||t-test, 2 sided|||||0.7808|-2.4147|0.2764
70897328|NCT02436330|141282718|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7958||||0.0008|TWO_SIDED|95.0|-1.235|-0.3566|||t-test, 2 sided|||||-0.3566|-1.2350|0.0008
70897329|NCT02436330|141282719|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7024||||0.6974|TWO_SIDED|95.0|-2.9377|4.3425|||t-test, 2 sided|||||4.3425|-2.9377|0.6974
70897330|NCT02436330|141282721|SUPERIORITY_OR_OTHER|||||||0.2122|TWO_SIDED||||||t-test, 2 sided|||||||0.2122
70897331|NCT02436330|141282722|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.61||||0.1265|TWO_SIDED|95.0|-1.15|8.33|||t-test, 2 sided|||||8.33|-1.15|0.1265
70897332|NCT02436330|141282723|SUPERIORITY_OR_OTHER|||||||0.3671|TWO_SIDED||||||t-test, 2 sided|||||||0.3671
70897333|NCT02436330|141282724|SUPERIORITY_OR_OTHER|||||||0.4892|TWO_SIDED||||||t-test, 2 sided|||||||0.4892
70897334|NCT00338884|141282730|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|35.3|||||TWO_SIDED|95.0|26.7|44.8|||||ORR=proportion of subjects with confirmed CR or PR, relative to total subjects who received at least 1 dose of study medication, had a baseline disease assessment, and had the correct histological cancer type.|||44.8|26.7|
70897335|NCT00338884|141282736|SUPERIORITY_OR_OTHER|||||||0.5581|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR Versus PD)||||0.5581
70897336|NCT00338884|141282736|SUPERIORITY_OR_OTHER|||||||0.7635|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR Versus PD)||||0.7635
70897337|NCT00338884|141282736|SUPERIORITY_OR_OTHER|||||||0.8366|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR Versus PD)||||0.8366
70897338|NCT00338884|141282736|SUPERIORITY_OR_OTHER|||||||0.0278|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR Versus PD)||||0.0278
70897339|NCT00338884|141282736|SUPERIORITY_OR_OTHER|||||||0.1988|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR Versus PD)||||0.1988
70897340|NCT00338884|141282736|SUPERIORITY_OR_OTHER|||||||0.2898|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR Versus PD)||||0.2898
70897341|NCT00338884|141282736|SUPERIORITY_OR_OTHER|||||||0.3567|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR Versus PD)||||0.3567
70897342|NCT00338884|141282736|SUPERIORITY_OR_OTHER|||||||0.4547|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR Versus PD)||||0.4547
70897343|NCT00338884|141282736|SUPERIORITY_OR_OTHER|||||||0.2809|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR Versus PD)||||0.2809
70897344|NCT00338884|141282736|SUPERIORITY_OR_OTHER|||||||0.3259|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR Versus PD)||||0.3259
70897345|NCT00338884|141282736|SUPERIORITY_OR_OTHER|||||||0.2702|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR Versus PD)||||0.2702
70897346|NCT00338884|141282737|SUPERIORITY_OR_OTHER|||||||0.7154|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.7154
70897347|NCT00338884|141282737|SUPERIORITY_OR_OTHER|||||||0.6263|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.6263
70897348|NCT00338884|141282737|SUPERIORITY_OR_OTHER|||||||0.9608|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.9608
70897349|NCT00338884|141282737|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.0300
70897350|NCT00338884|141282737|SUPERIORITY_OR_OTHER|||||||0.0927|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.0927
70897351|NCT00338884|141282737|SUPERIORITY_OR_OTHER|||||||0.2873|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2873
70897352|NCT00338884|141282737|SUPERIORITY_OR_OTHER|||||||0.3018|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3018
70897353|NCT00338884|141282737|SUPERIORITY_OR_OTHER|||||||0.4161|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.4161
70897354|NCT00338884|141282737|SUPERIORITY_OR_OTHER|||||||0.3069|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3069
70897355|NCT00338884|141282737|SUPERIORITY_OR_OTHER|||||||0.292|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2920
70897356|NCT00338884|141282737|SUPERIORITY_OR_OTHER|||||||0.2409|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2409
70897357|NCT00338884|141282739|SUPERIORITY_OR_OTHER|||||||0.5784|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR Versus PD)||||0.5784
70897358|NCT00338884|141282739|SUPERIORITY_OR_OTHER|||||||0.6251|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR Versus PD)||||0.6251
70897359|NCT00338884|141282739|SUPERIORITY_OR_OTHER|||||||0.1639|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR Versus PD)||||0.1639
70897360|NCT00338884|141282739|SUPERIORITY_OR_OTHER|||||||0.2782|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR Versus PD)||||0.2782
70897361|NCT00338884|141282739|SUPERIORITY_OR_OTHER|||||||0.8627|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR Versus PD)||||0.8627
70897362|NCT00338884|141282739|SUPERIORITY_OR_OTHER|||||||0.462|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR Versus PD)||||0.4620
70897363|NCT00338884|141282739|SUPERIORITY_OR_OTHER|||||||0.7575|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR Versus PD)||||0.7575
70897364|NCT00338884|141282739|SUPERIORITY_OR_OTHER|||||||0.3566|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR Versus PD)||||0.3566
70897365|NCT00338884|141282739|SUPERIORITY_OR_OTHER|||||||0.2809|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR Versus PD)||||0.2809
70897366|NCT00338884|141282739|SUPERIORITY_OR_OTHER|||||||0.8758|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR Versus PD)||||0.8758
70897367|NCT00338884|141282739|SUPERIORITY_OR_OTHER|||||||0.2702|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR Versus PD)||||0.2702
70897368|NCT00338884|141282740|SUPERIORITY_OR_OTHER|||||||0.7267|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.7267
70897369|NCT00338884|141282740|SUPERIORITY_OR_OTHER|||||||0.8555|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.8555
70897370|NCT00338884|141282740|SUPERIORITY_OR_OTHER|||||||0.2259|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2259
70897371|NCT00338884|141282740|SUPERIORITY_OR_OTHER|||||||0.2074|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2074
70897372|NCT00338884|141282740|SUPERIORITY_OR_OTHER|||||||0.4779|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.4779
70897373|NCT00338884|141282740|SUPERIORITY_OR_OTHER|||||||0.3628|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3628
70897374|NCT00338884|141282740|SUPERIORITY_OR_OTHER|||||||0.546|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.5460
70897375|NCT00338884|141282740|SUPERIORITY_OR_OTHER|||||||0.3637|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3637
70897376|NCT00338884|141282740|SUPERIORITY_OR_OTHER|||||||0.2229|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2229
70897377|NCT00338884|141282740|SUPERIORITY_OR_OTHER|||||||0.9759|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.9759
70897378|NCT00338884|141282740|SUPERIORITY_OR_OTHER|||||||0.2179|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2179
70897379|NCT00338884|141282742|SUPERIORITY_OR_OTHER|||||||0.5784|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR Versus PD)||||0.5784
70897380|NCT00338884|141282742|SUPERIORITY_OR_OTHER|||||||0.9625|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR Versus PD)||||0.9625
70897381|NCT00338884|141282742|SUPERIORITY_OR_OTHER|||||||0.8519|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR Versus PD)||||0.8519
70897382|NCT00338884|141282742|SUPERIORITY_OR_OTHER||Wilcoxon Rank Sum Test|||||0.0513|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR Versus PD)||||0.0513
70897383|NCT00338884|141282742|SUPERIORITY_OR_OTHER|||||||0.4051|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR Versus PD)||||0.4051
70897384|NCT00338884|141282742|SUPERIORITY_OR_OTHER|||||||0.2548|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR Versus PD)||||0.2548
70897385|NCT00338884|141282742|SUPERIORITY_OR_OTHER|||||||0.5091|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR Versus PD)||||0.5091
70897386|NCT00338884|141282742|SUPERIORITY_OR_OTHER|||||||0.3133|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR Versus PD)||||0.3133
70897387|NCT00338884|141282742|SUPERIORITY_OR_OTHER|||||||0.9278|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR Versus PD)||||0.9278
70897388|NCT00338884|141282742|SUPERIORITY_OR_OTHER|||||||0.407|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR Versus PD)||||0.4070
70897389|NCT00338884|141282742|SUPERIORITY_OR_OTHER|||||||0.2703|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR Versus PD)||||0.2703
70897390|NCT00338884|141282743|SUPERIORITY_OR_OTHER|||||||0.7267|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.7267
70897391|NCT00338884|141282743|SUPERIORITY_OR_OTHER|||||||0.8286|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.8286
70897392|NCT00338884|141282743|SUPERIORITY_OR_OTHER|||||||0.6867|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.6867
70897393|NCT00338884|141282743|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.0450
70897394|NCT00338884|141282743|SUPERIORITY_OR_OTHER|||||||0.174|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.1740
70897395|NCT00338884|141282743|SUPERIORITY_OR_OTHER|||||||0.2703|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2703
70897396|NCT00338884|141282743|SUPERIORITY_OR_OTHER|||||||0.3659|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3659
70897397|NCT00338884|141282743|SUPERIORITY_OR_OTHER|||||||0.3391|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3391
70897398|NCT00338884|141282743|SUPERIORITY_OR_OTHER|||||||0.98|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.9800
70897399|NCT00338884|141282743|SUPERIORITY_OR_OTHER|||||||0.335|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3350
70897400|NCT00338884|141282743|SUPERIORITY_OR_OTHER|||||||0.2179|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2179
70897401|NCT00338884|141282746|SUPERIORITY_OR_OTHER|||||||0.068|TWO_SIDED||||||Wilcoxon Rank Sum Test|||CR or PR Versus PD||||0.0680
70897402|NCT00338884|141282747|SUPERIORITY_OR_OTHER|||||||0.1159|TWO_SIDED||||||Wilcoxon Rank Sum Test|||CR or PR or (SD \> = 12 Weeks) Versus PD||||0.1159
70897403|NCT00338884|141282749|SUPERIORITY_OR_OTHER|||||||0.8519|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR Versus PD)||||0.8519
70897404|NCT00338884|141282749|SUPERIORITY_OR_OTHER|||||||0.5879|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR Versus PD)||||0.5879
70897405|NCT00338884|141282749|SUPERIORITY_OR_OTHER|||||||0.4757|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR Versus PD)||||0.4757
70897406|NCT00338884|141282749|SUPERIORITY_OR_OTHER|||||||0.1933|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR Versus PD)||||0.1933
70897407|NCT00338884|141282749|SUPERIORITY_OR_OTHER|||||||0.4187|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR Versus PD)||||0.4187
70897408|NCT00338884|141282749|SUPERIORITY_OR_OTHER|||||||0.3795|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR Versus PD)||||0.3795
70897409|NCT00338884|141282749|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR Versus PD)||||1.0000
70897410|NCT00338884|141282749|SUPERIORITY_OR_OTHER|||||||0.6333|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR Versus PD)||||0.6333
70897411|NCT00338884|141282749|SUPERIORITY_OR_OTHER|||||||0.8679|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR Versus PD)||||0.8679
70897412|NCT00338884|141282749|SUPERIORITY_OR_OTHER|||||||0.592|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR Versus PD)||||0.5920
70897413|NCT00338884|141282750|SUPERIORITY_OR_OTHER|||||||0.6939|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.6939
70897414|NCT00338884|141282750|SUPERIORITY_OR_OTHER|||||||0.5871|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.5871
70897415|NCT00338884|141282750|SUPERIORITY_OR_OTHER|||||||0.4572|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.4572
70897416|NCT00338884|141282750|SUPERIORITY_OR_OTHER|||||||0.112|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.1120
70897417|NCT00338884|141282750|SUPERIORITY_OR_OTHER|||||||0.4896|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.4896
70897418|NCT00338884|141282750|SUPERIORITY_OR_OTHER|||||||0.2369|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2369
70897419|NCT00338884|141282750|SUPERIORITY_OR_OTHER|||||||0.6709|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.6709
70897420|NCT00338884|141282750|SUPERIORITY_OR_OTHER|||||||0.6382|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.6382
70897421|NCT00338884|141282750|SUPERIORITY_OR_OTHER|||||||0.8481|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.8481
70897422|NCT00338884|141282750|SUPERIORITY_OR_OTHER|||||||0.3731|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3731
70897423|NCT00338884|141282752|SUPERIORITY_OR_OTHER|||||||0.0292|TWO_SIDED||||||Wilcoxon Rank Sum Test|||CR or PR Versus PD||||0.0292
70897424|NCT00338884|141282753|SUPERIORITY_OR_OTHER|||||||0.1087|TWO_SIDED||||||Wilcoxon Rank Sum Test|||CR or PR or (SD \> = 12 Weeks) Versus PD||||0.1087
70897425|NCT00338884|141282755|SUPERIORITY_OR_OTHER|||||||0.3386|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR Versus PD)||||0.3386
70897426|NCT00338884|141282755|SUPERIORITY_OR_OTHER|||||||0.1949|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR Versus PD)||||0.1949
70897427|NCT00338884|141282755|SUPERIORITY_OR_OTHER|||||||0.7037|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR Versus PD)||||0.7037
70897428|NCT00338884|141282755|SUPERIORITY_OR_OTHER|||||||0.5748|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR Versus PD)||||0.5748
70897429|NCT00338884|141282755|SUPERIORITY_OR_OTHER|||||||0.747|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR Versus PD)||||0.7470
70897430|NCT00338884|141282755|SUPERIORITY_OR_OTHER|||||||0.4703|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR Versus PD)||||0.4703
70897431|NCT00338884|141282755|SUPERIORITY_OR_OTHER|||||||0.8162|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR Versus PD)||||0.8162
70897432|NCT00338884|141282755|SUPERIORITY_OR_OTHER|||||||0.5465|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR Versus PD)||||0.5465
70897433|NCT00338884|141282755|SUPERIORITY_OR_OTHER|||||||0.3495|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR Versus PD)||||0.3495
70897434|NCT00338884|141282755|SUPERIORITY_OR_OTHER|||||||0.6397|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR Versus PD)||||0.6397
70897435|NCT00338884|141282756|SUPERIORITY_OR_OTHER|||||||0.4632|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.4632
70897436|NCT00338884|141282756|SUPERIORITY_OR_OTHER|||||||0.1701|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.1701
70897437|NCT00338884|141282756|SUPERIORITY_OR_OTHER|||||||0.8204|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.8204
70897438|NCT00338884|141282756|SUPERIORITY_OR_OTHER|||||||0.5162|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.5162
70897439|NCT00338884|141282756|SUPERIORITY_OR_OTHER|||||||0.9437|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.9437
70897440|NCT00338884|141282756|SUPERIORITY_OR_OTHER|||||||0.4013|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.4013
70897441|NCT00338884|141282756|SUPERIORITY_OR_OTHER|||||||0.9595|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.9595
70897442|NCT00338884|141282756|SUPERIORITY_OR_OTHER|||||||0.6249|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.6249
70897443|NCT00338884|141282756|SUPERIORITY_OR_OTHER|||||||0.3731|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3731
70897444|NCT00338884|141282756|SUPERIORITY_OR_OTHER|||||||0.8263|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.8263
70897445|NCT01970982|141282766|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|23.09|||<|0.001|TWO_SIDED|95.0|18.41|28.95||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||28.95|18.41|<0.001
70897446|NCT01970982|141282767|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|52.86|||<|0.001|TWO_SIDED|95.0|45.67|61.17||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on 3-HPMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||61.17|45.67|<0.001
70897447|NCT01970982|141282768|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|15.68|||<|0.001|TWO_SIDED|95.0|13.09|18.78||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on S-PMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||18.78|13.09|<0.001
70897448|NCT01970982|141282769|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|47.1|||<|0.001|TWO_SIDED|95.0|44.3|50.08||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on COHb levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||50.08|44.30|<0.001
70897449|NCT04496219|141282782|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||This p value relates to instillation adherence||||0.97
70897450|NCT04496219|141282782|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||This p value relates to missed visits.||||0.17
70897451|NCT04496219|141282783|SUPERIORITY|||||||0.5638|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Constipation Symptoms.||||0.5638
70897452|NCT04496219|141282783|SUPERIORITY|||||||0.1753|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Diarrhea Symptoms.||||0.1753
70897453|NCT04496219|141282783|SUPERIORITY|||||||0.2062|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Urinary Symptoms.||||0.2062
70897454|NCT04496219|141282784|SUPERIORITY|||||||0.8092|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Global Health.||||0.8092
70897455|NCT04496219|141282784|SUPERIORITY|||||||0.5492|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Physical Function.||||0.5492
70897456|NCT04496219|141282784|SUPERIORITY|||||||0.6464|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Emotional Function.||||0.6464
70897457|NCT04496219|141282784|SUPERIORITY|||||||0.586|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Social Function.||||0.586
70897458|NCT04496219|141282784|SUPERIORITY|||||||0.8999|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Fatigue Symptoms.||||0.8999
70897459|NCT04496219|141282784|SUPERIORITY|||||||0.2007|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Pain Symptoms.||||0.2007
70897460|NCT04496219|141282784|SUPERIORITY|||||||0.9921|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Malaise Symptoms.||||0.9921
70897461|NCT04496219|141282784|SUPERIORITY|||||||0.5723|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Role Function.||||0.5723
70897462|NCT04496219|141282784|SUPERIORITY|||||||0.812|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Cognitive Function.||||0.812
70897463|NCT04496219|141282784|SUPERIORITY|||||||0.96|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Nausea Symptoms.||||0.96
70897464|NCT04496219|141282784|SUPERIORITY|||||||0.1062|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Dyspnoea Symptoms.||||0.1062
70897465|NCT04496219|141282784|SUPERIORITY|||||||0.3259|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Insomnia Symptoms.||||0.3259
70897466|NCT04496219|141282784|SUPERIORITY|||||||0.9664|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Appetite Loss Symptoms.||||0.9664
70897467|NCT04496219|141282784|SUPERIORITY|||||||0.4564|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Finances.||||0.4564
70897468|NCT04496219|141282784|SUPERIORITY|||||||0.1036|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Intravesical Symptoms.||||0.1036
70897469|NCT04496219|141282784|SUPERIORITY|||||||0.1789|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Worries.||||0.1789
70897470|NCT04496219|141282784|SUPERIORITY|||||||0.5186|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Bloating Symptoms.||||0.5186
70897471|NCT04496219|141282784|SUPERIORITY|||||||0.0757|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Sexual Function.||||0.0757
70897472|NCT04496219|141282784|SUPERIORITY|||||||0.1174|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Male Sex Problems.||||0.1174
70897473|NCT04496219|141282784|SUPERIORITY|||||||0.3129|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Intimacy.||||0.3129
70897474|NCT03053050|141282793|SUPERIORITY||Percentage Difference|-2.1||||0.4941|TWO_SIDED|95.0|-8.3|4.0||Difference between SEL 18 mg and Placebo, 95% confidence interval (CI) and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and Enhanced Liver Fibrosis (ELF) test score as stratification factors.|Mantel Haenszel|||||4.0|-8.3|0.4941
70897475|NCT03053050|141282793|SUPERIORITY||Percentage Difference|-0.3||||0.9321|TWO_SIDED|95.0|-6.6|6.0||Difference between SEL 6 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||6.0|-6.6|0.9321
70897476|NCT03053050|141282795|SUPERIORITY||Percentage Difference|-4.0||||0.2593|TWO_SIDED|95.0|-10.8|2.9||Difference between SEL 18 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||2.9|-10.8|0.2593
70897477|NCT03053050|141282795|SUPERIORITY||Percentage Difference|-0.9||||0.808|TWO_SIDED|95.0|-7.9|6.1||Difference between SEL 6 mg vs Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||6.1|-7.9|0.8080
70897478|NCT03053050|141282797|SUPERIORITY||Percentage Difference|-2.0||||0.5636|TWO_SIDED|95.0|-8.7|4.8||Difference between SEL 18 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||4.8|-8.7|0.5636
70897479|NCT03053050|141282797|SUPERIORITY||Percentage Difference|-1.9||||0.5915|TWO_SIDED|95.0|-8.6|4.9||Difference between SEL 6 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||4.9|-8.6|0.5915
70897480|NCT03053050|141282799|SUPERIORITY||Percentage Difference|-3.2||||0.2455|TWO_SIDED|95.0|-8.5|2.2||Difference between SEL 18 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||2.2|-8.5|0.2455
70897481|NCT03053050|141282799|SUPERIORITY||Percentage Difference|-4.0||||0.1371|TWO_SIDED|95.0|-9.3|1.3||Difference between SEL 6 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||1.3|-9.3|0.1371
70897482|NCT02459574|141282801|SUPERIORITY||Hazard Ratio (HR)|0.156|||<|0.0001|TWO_SIDED|95.0|0.097|0.25||Bonferonni corrected alpha of 0.05/2 = 0.025|Log Rank||95% Wald Confidence Limits Point estimate relates to AVATAR-AF in relation to Anti-Arrhythmic Therapy|Primary Analysis - AVATAR-AF vs Anti-Arrhythmic Therapy||0.250|0.097|<0.0001
70897483|NCT02459574|141282801|SUPERIORITY||Hazard Ratio (HR)|1.173||||0.6061|TWO_SIDED|95.0|0.639|2.154||Bonferonni corrected alpha 0.05/2 = 0.025|Log Rank||95% Wald Confidence Limits Point estimate relates to AVATAR-AF in relation to Conventional Ablation|Secondary analysis of Primary Outcome measure - AVATAR-AF vs Conventional Ablation||2.154|0.639|0.6061
70897484|NCT00251745|141282805|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
70897485|NCT00251745|141282805|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
70897486|NCT00251745|141282805|SUPERIORITY_OR_OTHER|||||||0.15505||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.15505
70897487|NCT00251745|141282807|SUPERIORITY_OR_OTHER|||||||1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.00001
70897488|NCT00251745|141282807|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
70897489|NCT00251745|141282807|SUPERIORITY_OR_OTHER|||||||0.3874||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.38740
70897490|NCT00636649|141282811|SUPERIORITY_OR_OTHER|||||||0.993|||||||ANCOVA|||CISS-TASK||||0.993
70897491|NCT00636649|141282811|SUPERIORITY_OR_OTHER|||||||0.185|||||||ANCOVA|||CISS-EMOT||||0.185
70897492|NCT00636649|141282811|SUPERIORITY_OR_OTHER|||||||0.196|||||||ANCOVA|||CISS-DIS||||0.196
70897493|NCT00636649|141282811|SUPERIORITY_OR_OTHER|||||||0.759|||||||ANCOVA|||CISS-AVD||||0.759
70897494|NCT00636649|141282811|SUPERIORITY_OR_OTHER|||||||0.396|||||||ANCOVA|||CISS-SOC||||0.396
70897495|NCT00636649|141282812|SUPERIORITY_OR_OTHER|||||||0.579|||||||ANCOVA|||||||0.579
70897496|NCT00636649|141282813|SUPERIORITY_OR_OTHER|||||||0.225|||||||ANCOVA|||TFEQ-RES||||0.225
70897497|NCT00636649|141282813|SUPERIORITY_OR_OTHER|||||||0.498|||||||ANCOVA|||TFEQ-DIS||||0.498
70897498|NCT00636649|141282813|SUPERIORITY_OR_OTHER|||||||0.724|||||||ANCOVA|||TFEQ-HUN||||0.724
70897499|NCT04508699|141282821|OTHER|||||||0.36|||||||t-test, 1 sided|||||||0.36
70897500|NCT04508699|141282822|OTHER||||||<|0.05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|ANOVA|||||||<0.05
70897501|NCT04508699|141282823|OTHER||||||<|0.05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|ANOVA|||||||<0.05
70897502|NCT04508699|141282824|OTHER||||||<|0.05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|ANOVA|||||||<0.05
70897503|NCT04508699|141282825|OTHER||||||<|0.05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|ANOVA|||||||<0.05
70897504|NCT04508699|141282826|OTHER||||||<|1e-05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|t-test, 1 sided|||||||<0.00001
70897505|NCT04508699|141282827|OTHER||||||<|1e-05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|t-test, 1 sided|||||||<0.00001
70897506|NCT04508699|141282828|OTHER||||||<|1e-05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|t-test, 1 sided|||||||<0.00001
70897507|NCT00361140|141282863|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Chi-squared|||||||.007
70897508|NCT00361140|141282864|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|6.27||||0.07|TWO_SIDED|95.0|0.92|42.48|||Gray|Gray RJ. A class of K-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat. 1988;16:1141-1154.||Sample size: dependent on dose escalation. Once the maximum tolerated dose (MTD) is reached, a total of 30 patients will be accrued to that level. If maximally tolerated AUC is level 1, a total of 30 patients will be treated on this level using tacrolimus and methotrexate as GVHD prophylaxis. This will provide 95% confidence intervals for 100-day non-relapse mortality and non-fatal toxicities with ½ widths not exceeding 0.18. Hazard ratios were calculated per the method of Gray (reference given)||42.48|0.92|.07
70897509|NCT00993655|141282876|SUPERIORITY|||||||0.065|||||||Cochran-Mantel-Haenszel|adjusting for stratification factors at randomization||Assume that the 9-month PD rate in IV arm (Arm 1) will be 40% (based on experience with data from NCIC CTG OV.16 and that of NCRI UK). The target sample size of 200 will enable the detection of a 19% difference between Arms 1 and 3 in 9 month progression disease rate post randomization with 80% power at two-sided 0.05 level.||||0.065
70897510|NCT00993655|141282877|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.27|TWO_SIDED|95.0|0.85|1.75|||Log Rank|Adjusting for stratification factors at randomization||||1.75|0.85|0.27
70897511|NCT00993655|141282878|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.4|TWO_SIDED|95.0|0.74|2.13|||Log Rank|Adjusting for stratification factors at randomization||||2.13|0.74|0.40
70897512|NCT00152464|141282922|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.002|||=|0.991|TWO_SIDED|95.0|0.75|1.338|||Regression, Cox|||||1.338|0.750|=0.991
70897513|NCT01644734|141282933|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Null hypothesis: no change in the total CAT score between baseline and after 3 months.||||<0.001
70897514|NCT05159622|141282934|EQUIVALENCE|A net effect of 6 fluid oz/day (SD=1) was hypothesized among adult parents, assuming two sided alpha=0.05, power = 80%, and a minimum sample size of 60 adults.|Median Difference (Final Values)|3.2||||0.15|TWO_SIDED|||||The a priori threshold for statistical significance is \<0.05. P-value of the interaction between treatment group and change in beverage consumption (fl oz/day).|t-test, 2 sided|||||||0.15
70897515|NCT05159622|141282935|EQUIVALENCE|This was an exploratory outcome.|Median Difference (Final Values)|0.07||||0.98|TWO_SIDED||||||t-test, 2 sided|||||||0.98
70897516|NCT05159622|141282936|EQUIVALENCE|This was an exploratory outcome and therefore statistical power was not based on a hypothesis of this outcome.|Median Difference (Final Values)|0.64||||0.36|TWO_SIDED||||||t-test, 2 sided|||||||0.36
70897517|NCT05159622|141282937|EQUIVALENCE|Exploratory outcome as for infants/toddlers based on parent-report|Median Difference (Final Values)|0.14||||0.92|TWO_SIDED||||||t-test, 2 sided|||||||0.92
70897518|NCT05159622|141282938|EQUIVALENCE|Exploratory outcome|Median Difference (Final Values)|0.95||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
70897519|NCT03384173|141282944|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
70897520|NCT03384173|141282945|OTHER|Correlation, Pearson r|Pearson r correlation|0.16||||0.17|TWO_SIDED|95.0|-0.07|0.37|||Pearson r correlation|||||0.37|-0.07|0.17
70897521|NCT03384173|141282946|OTHER|Correlation, Pearson r|Pearson r correlation|0.12||||0.32|TWO_SIDED|95.0|-0.11|0.33|||Pearson r correlation|||||0.33|-0.11|0.32
70897522|NCT03384173|141282948|OTHER|Mann Whitney U non parametric test|||||<|0.01||||||"A-priori threshold p\<0.05 for 'subgroup 20-29.99%' vs 'baseline value before caffeine dose'.~A-priori threshold p\<0.05 for 'subgroup 30-39.99%' vs 'baseline value before caffeine dose'."|Wilcoxon (Mann-Whitney)|||Control group is Secondary analysis #4, baseline values before caffeine dose.||||<0.01
70897523|NCT03384173|141282949|OTHER|Mann Whitney U non parametric test|||||<|0.001||||||A-priori threshold p\<0.05 for 'subgroup 20-29.99%' vs 'baseline value before caffeine dose'.|Wilcoxon (Mann-Whitney)|||Control group is secondary outcome #4, baseline values before caffeine dose||||<0.001
70897524|NCT03384173|141282950|OTHER|Mann-Whitney U non parametric t test|||||<|0.01||||||"A-priori threshold p\<0.05 for 'subgroup 20-29.99%' vs 'baseline value before caffeine dose'.~A-priori threshold p\<0.05 for 'subgroup \>60% ' vs 'baseline value before caffeine dose'."|Wilcoxon (Mann-Whitney)|||Comparison group is Secondary outcome #4, baseline caffeine values by subgroup||||<0.01
70897525|NCT03384173|141282951|OTHER||||||<|0.0001||||||A-priori threshold p\<0.05 for 'subgroup 20-29.99%' vs 'baseline value before caffeine dose'.|Wilcoxon (Mann-Whitney)|||Comparison group is secondary outcome #4, baseline values before caffeine dose||||<0.0001
70897526|NCT03384173|141282952|OTHER|Mann Whitney U non-parametric t-test|||||<|0.05||||||A-priori threshold p\<0.05 for 'subgroup 20-29.99%' vs 'baseline value before caffeine dose'.|Wilcoxon (Mann-Whitney)|||Comparison group is Secondary Outcome #4, baseline before dose of caffeine.||||<0.05
70897527|NCT01984684|141282979|NON_INFERIORITY|A 2-sided 95% confidence interval (CI) for noninferiority testing was computed based on the difference in responder rates for vancomycin + aztreonam and delafloxacin at the primary endpoint. If the upper limit (UL) of the CI was less than 0.10, delafloxacin would be considered noninferior to vancomycin + aztreonam.|Difference in Responder Rates|3.1|||||TWO_SIDED|95.0|-2.0|8.3||||||||8.3|-2.0|
70897528|NCT01984684|141282980|NON_INFERIORITY|Analysis of the investigator's assessment of response of signs and symptoms of infection (cure only) was performed using the Miettinen-Nurminen method without stratification for the ITT analysis set.|Difference in Cure Rates|-2.0|||||TWO_SIDED|95.0|-8.6|4.6||||||||4.6|-8.6|
70897529|NCT01984684|141282981|NON_INFERIORITY|Analysis of the investigator's assessment of response (cure only) at the Late Follow-up Visit was assessed using the Miettinen-Nurminen method without stratification.|Difference in Cure Rates|-3.1|||||TWO_SIDED|95.0|-9.3|3.1||||||||3.1|-9.3|
70897530|NCT04575051|141282982|SUPERIORITY||Mean Difference (Final Values)|0.43||||0.58|TWO_SIDED|95.0|-1.1|1.96|||Mixed Models Analysis||Difference in the adjusted means for the Consult model and HearCARE model.|The null hypothesis is that the HearCARE intervention does not improve satisfaction with social participation.||1.96|-1.10|0.58
70897531|NCT04575051|141282983|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.95|TWO_SIDED|95.0|-1.13|1.1|||Mixed Models Analysis||The estimated parameter represents the difference between the adjusted means for the Consult and HearCARE models.|The null hypothesis is that the HearCARE intervention does not improve hearing related quality of life.||1.10|-1.13|0.95
70897532|NCT04575051|141282984|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.96|TWO_SIDED|95.0|-1.2|1.14|||Mixed Models Analysis||Estimated Value represents the difference in the means for the Consult and HearCARE models.|||1.14|-1.20|0.96
70897533|NCT04575051|141282985|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.13|TWO_SIDED|95.0|-0.07|0.48|||Mixed Models Analysis||The Estimated Value is the difference between the means of the Consult and HearCARE models.|||0.48|-0.07|0.13
70897534|NCT01215292|141282999|NON_INFERIORITY_OR_EQUIVALENCE|80% power to detect 20% difference in ITT|||||<|0.05|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||<0.05
70897535|NCT01215292|141283000|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||<0.05
70897536|NCT01215292|141283001|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||<0.05
70897537|NCT04672941|141283002|OTHER|Mixed model for repeated measurements (MMRM) assuming random missingness was fitted. The dependent variable was the CAT score at each visit. Visit, Global Initiative for Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates.|Score on a scale|-5.28|||||TWO_SIDED|95.0|-5.67|-4.89|||||Least Square Mean for Visit, change from baseline (3 months - baseline) total CAT Score estimates.|||-4.89|-5.67|
70897538|NCT04672941|141283003|OTHER|The logistic generalized estimating equations (GEE) model with CAT response \>= 10 as dependent variable. Visit, Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates and unstructured covariance matrix was used.|Odds Ratio (OR)|7.186|||<|0.001|TWO_SIDED|95.0|5.745|8.987|||Regression, Logistic||Odds ratio for Visit.|||8.987|5.745|< 0.001
70897539|NCT04672941|141283004|OTHER|Mixed model for repeated measurements (MMRM) assuming random missingness was fitted. The dependent variable was EQ-VAS score. Visit, Global Initiative for Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates.|Score on a scale|11.8|||||TWO_SIDED|95.0|11.0|12.6|||||Least Square Mean for Visit, mean change from Baseline (3 months - baseline) of EQ-VAS based on non-responder imputation.|||12.60|11.00|
70897540|NCT04672941|141283005|OTHER|The logistic generalized estimating equations (GEE) model with mobility as dependent variable. Visit, Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates and unstructured covariance matrix was used.|Odds Ratio (OR)|4.48|||<|0.001|TWO_SIDED|95.0|3.9|5.14|||Regression, Logistic||Odds ratio for Visit (3 months / baseline (reference)).|||5.14|3.90|< 0.001
70897541|NCT04672941|141283006|OTHER|The logistic generalized estimating equations (GEE) model with self-care as dependent variable. Visit, Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates and unstructured covariance matrix was used.|Odds Ratio (OR)|2.64|||<|0.001|TWO_SIDED|95.0|2.35|2.96|||Regression, Logistic||Odds ratio for Visit (3 months / baseline (reference)).|||2.96|2.35|< 0.001
70897542|NCT04672941|141283007|OTHER|The logistic generalized estimating equations (GEE) model with usual activities as dependent variable. Visit, Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates and unstructured covariance matrix was used.|Odds Ratio (OR)|4.46|||<|0.001|TWO_SIDED|95.0|3.89|5.12|||Regression, Logistic||Odds ratio for Visit (3 months / baseline (reference)).|||5.12|3.89|< 0.001
70897543|NCT04672941|141283008|OTHER|The logistic generalized estimating equations (GEE) model with pain/discomfort as dependent variable. Visit, Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates and unstructured covariance matrix was used.|Odds Ratio (OR)|3.4|||<|0.001|TWO_SIDED|95.0|3.0|3.85|||Regression, Logistic||Odds ratio for Visit (3 months / baseline (reference)).|||3.85|3.00|< 0.001
70897544|NCT04672941|141283009|OTHER|The logistic generalized estimating equations (GEE) model with anxiety/depression as dependent variable. Visit, Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates and unstructured covariance matrix was used.|Odds Ratio (OR)|3.32|||<|0.001|TWO_SIDED|95.0|2.95|3.73|||Regression, Logistic||Odds ratio for Visit (3 months / baseline (reference)).|||3.73|2.95|< 0.001
70897545|NCT04672941|141283015|OTHER|Mixed model for repeated measurements (MMRM) assuming random missingness was fitted. The dependent variable was the mMRC score. Visit, Global Initiative for Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates.|Score on a scale|-0.55|||||TWO_SIDED|95.0|-0.6|-0.51|||||Least Square Mean for Visit, change from baseline (3 months - baseline) of mMRC based on non-responder imputation.|||-0.51|-0.60|
70897546|NCT00765388|141283021|SUPERIORITY_OR_OTHER|||||||0.96|||||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference in the multinomial distributions defined by products||||||0.96
70897547|NCT00765388|141283023|SUPERIORITY_OR_OTHER|||||||0.92|||||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference in the multinomial distributions defined by products||||||0.92
70897548|NCT00765388|141283025|SUPERIORITY_OR_OTHER|||||||0.4||0.0|||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference inthe multinomial distributions defined by products||||||0.40
70897549|NCT00765388|141283026|SUPERIORITY_OR_OTHER|||||||0.64|||||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference inthe multinomial distributions defined by products||||||0.64
70897550|NCT00765388|141283027|SUPERIORITY_OR_OTHER|||||||0.55|||||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference inthe multinomial distributions defined by products||||||0.55
70897551|NCT00765388|141283028|SUPERIORITY_OR_OTHER|||||||0.48|||||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference inthe multinomial distributions defined by products||||||0.48
70897552|NCT02342886|141283035|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% confidence interval (CI) for the difference between the percentage of patients who are classified as having an unfavourable status on the intervention (6 months moxifloxacin + 200 mg PA-824 + pyrazinamide) and the control regimen (2 months HRZE/ 4 months HR). The intervention was considered to be non-inferior to the control arm if the upper bound 95% CI was \< 12%.|Treatment difference: unfavourable rate|9.88|||||TWO_SIDED|95.0|-4.13|23.89|||||(DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide) - (DS-TB: 2 Months HRZE/ 4 Months HR).|||23.89|-4.13|
70897553|NCT02342886|141283036|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavourable status on the intervention (6 months moxifloxacin + 200 mg PA-824 + pyrazinamide) and the control regimen (2 months HRZE/ 4 months HR). The intervention was considered to be non-inferior to the control arm if the upper bound 95% CI was \< 12%.|Treatment difference: unfavourable rate|6.62|||||TWO_SIDED|95.0|-2.15|15.4|||||(DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide) - (DS-TB: 2 Months HRZE/ 4 Months HR).|||15.40|-2.15|
70897554|NCT01163097|141283056|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence of the treatments was assessed using the 90% confidence interval (CI) of the geometric mean ratio for Ki67. The lower bound of the CI needed to be greater than 0.70 and the upper bound needed to be below 1.43 for the treatments to be considered equivalent.|Geometric mean ratio|0.863|||||TWO_SIDED|90.0|0.759|0.982|||ANCOVA|ANCOVA was used to estimate the treatment effect and the Schuirmann's two one-sided test was used to test for statistical equivalence.||H0: mean ratio\<0.7 or mean ratio\>1.43; H1: 0.7\< mean ratio \<1.43 Sample size calculation assumed change in Ki67 expression following palifermin administration would not be affected by co-administration of heparin. With n=26 (13 + 13), an approx. 80% probability that the 90% CI of the ratio of geometric means of Ki67 for palifermin when co-administered with heparin compared to palifermin alone would fall in the interval (0.7, 1.43). This assumed a Coefficient of Variation (CV) for Ki67 of 31%.||0.982|0.759|
70897555|NCT01163097|141283058|SUPERIORITY_OR_OTHER||Geometric mean|0.737|||||TWO_SIDED|95.0|0.614|0.885|||ANCOVA|ANCOVA (with dependent variable:natural log of the ratio to baseline, independent variable:treatment, covariate:natural log of the baseline value)||80% power achieved for detecting a 20% increase (or 17% reduction) when Treatment A was compared to Treatment B; assuming that the coefficient of variation of amylase would be 14% (as observed in other study)||0.885|0.614|
70897556|NCT01163097|141283059|SUPERIORITY_OR_OTHER||Geometric mean|0.373|||||TWO_SIDED|95.0|0.216|0.645|||ANCOVA|ANCOVA (with dependent variable:natural log of the ratio to baseline, independent variable:treatment, covariate:natural log of the baseline value)||80% power achieved for detecting a 70% increase (or 41% reduction) when Treatment A was compared to Treatment B; assuming that the coefficient of variation of lipase would be 49% (as observed in other study)||0.645|0.216|
70897557|NCT01163097|141283060|SUPERIORITY_OR_OTHER||Geometric mean|0.972|||||TWO_SIDED|95.0|0.768|1.231|||ANCOVA|ANCOVA (with dependent variable:natural log of the ratio to baseline, independent variable:treatment, covariate:natural log of the baseline value)||80% power achieved for detecting a 140% increase with 13 and 6 subjects (respectively) when Treatment B was compared to Treatment C; assuming that the coefficient of variation of the protein/creatinine ratio would be 67% (Ginsberg et al 1983)||1.231|0.768|
70897558|NCT01163097|141283061|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0|||||ANOVA|||||||<0.0001
70897559|NCT01163097|141283062|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0|||||ANOVA|||||||<0.0001
70897560|NCT01163097|141283063|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0|||||ANOVA|||||||<0.0001
70897561|NCT01163097|141283064|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0|||||ANOVA|||||||<0.0001
70897562|NCT01163097|141283065|SUPERIORITY_OR_OTHER|||||||0.4123||90.0|||||ANOVA|||||||0.4123
70897563|NCT01163097|141283066|SUPERIORITY_OR_OTHER|||||||0.9944||90.0|||||ANOVA|||||||0.9944
70897564|NCT01163097|141283067|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0|||||ANOVA|||||||<0.0001
70897565|NCT01163097|141283068|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0|||||ANOVA|||||||<0.0001
70897566|NCT01569438|141283078|OTHER||Mean Difference|-0.7||||0.0734|TWO_SIDED|90.0|-1.6|0.2||one-sided|Mixed Model with Repeated Measures|||MMRM approach was used to model the change from baseline as a function of treatment, week, treatment by week interaction, baseline score, and baseline score by week interaction.||0.2|-1.6|0.0734
70897567|NCT01569438|141283079|OTHER||Mean Difference|-1.0||||0.2726|TWO_SIDED|90.0|-3.9|1.8||one-sided|Mixed Model With Repeated Measures|||MMRM approach was used to model the change from baseline as a function of treatment, week, treatment by week interaction, baseline score, and baseline score by week interaction.||1.8|-3.9|0.2726
70897568|NCT01569438|141283080|OTHER||Mean Difference|-0.3||||0.3603|TWO_SIDED|90.0|-1.7|1.1||one-sided|ANCOVA|||The one-way ANCOVA model was used to calculate change from baseline as a function of treatment and baseline score.||1.1|-1.7|0.3603
70897569|NCT01569438|141283081|OTHER||Mean Difference|-1.5||||0.1183|TWO_SIDED|90.0|-3.5|0.6||one-sided|ANCOVA|||The one-way ANCOVA model was used to calculate change from baseline as a function of treatment and baseline score.||0.6|-3.5|0.1183
70897570|NCT00452387|141283083|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Fisher Exact|||The test of association of PSA and imaging response tests the null hypothesis that the proportion of cases exhibiting PSA response is the same for patients with and without a favorable imaging response. A 2x2 table was constructed based on the number of the patients in imaging response (favorable and unfavorable) and PSA response (\>50% reduction and \<=50% reduction). The Fisher's exact test was used to test this hypothesis.||||0.55
70897571|NCT01693068|141283089|OTHER|A log-rank test stratified by baseline Eastern Cooperative Oncology Group performance status (ECOG PS) (using the interactive voice response system \[IVRS\] value) will tested the null hypothesis of no difference between the Pimasertib (first line) and the Dacarbazine treatment groups at the 5% level.|Hazard Ratio (HR)|0.59||||0.0022|TWO_SIDED|95.0|0.42|0.83|||Stratified Log Rank Test||The Hazard Ratio is obtained from the Cox Proportional Hazards model based on dacarbazine and pimasertib only stratified by baseline ECOG Performance Status.|||0.83|0.42|0.0022
70897572|NCT00579280|141283100|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
70897573|NCT00579280|141283101|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
70897574|NCT00579280|141283102|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
70897575|NCT00579280|141283103|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<.05
70897576|NCT00579280|141283104|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
70897577|NCT00579280|141283105|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
70897578|NCT00579280|141283106|SUPERIORITY||||||<|0.05|||||||Chi-squared|Differences in response (70% or greater improvement) and remission (50% or greater improvement) rates between the groups.||||||<0.05
70897579|NCT00579280|141283107|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
70897580|NCT00579280|141283108|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
70897581|NCT00579280|141283109|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
70897582|NCT00579280|141283110|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
70897583|NCT02510144|141283111|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||Negative cultures were compared on the treated side vs the non-treated side||||0.68
70897584|NCT02510144|141283111|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||Negative cultures were compared on the treated side versus the non-treated side||||<0.01
70897585|NCT00977665|141283113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.603||||0.6984|TWO_SIDED|95.0|-3.677|2.47||A priori threshold for statistical significance is 0.05.|repeated measures model|Fixed effects: categorical week in trial by treatment interaction, center, and baseline UMSARS score.||||2.470|-3.677|0.6984
70897586|NCT00977665|141283122|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.189|||||TWO_SIDED|95.0|0.646|2.186||||||||2.186|0.646|
70897587|NCT02291679|141283205|SUPERIORITY||Odds Ratio (OR)|3.03|||<|0.0001|TWO_SIDED|95.0|1.76|5.2||P-value is obtained from the Cochran-Mantel-Haenszel (CMH) tests controlling for baseline SBM stratum and geographic region.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% confidence interval (CI) for the odds ratio are obtained from the CMH tests controlling for baseline SBM stratum and geographic region.|||5.20|1.76|< 0.0001
70897588|NCT02291679|141283206|SUPERIORITY||LS Mean Difference|0.841|||<|0.0001|TWO_SIDED|95.0|0.505|1.176||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|||1.176|0.505|< 0.0001
70897589|NCT02291679|141283207|SUPERIORITY||LS Mean Difference|1.037|||<|0.0001|TWO_SIDED|95.0|0.636|1.438||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a LS mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|||1.438|0.636|< 0.0001
70897590|NCT02291679|141283208|SUPERIORITY||LS Mean Difference|0.628|||<|0.0001|TWO_SIDED|95.0|0.45|0.806||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a LS mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|||0.806|0.450|< 0.0001
70897591|NCT02291679|141283209|SUPERIORITY||LS Mean Difference|-0.329|||<|0.0001|TWO_SIDED|95.0|-0.449|-0.21||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a LS mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|||-0.210|-0.449|< 0.0001
70897592|NCT02291679|141283210|SUPERIORITY||Odds Ratio (OR)|2.68||||0.0008|TWO_SIDED|95.0|1.47|4.87||P-value is obtained from the CMH tests controlling for geographic region.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% CI for the odds ratio are obtained from the CMH tests controlling for geographic region.|||4.87|1.47|0.0008
70897593|NCT02291679|141283211|SUPERIORITY||Odds Ratio (OR)|2.58|||<|0.0001|TWO_SIDED|95.0|1.58|4.2||P-value is obtained from the CMH tests controlling for geographic region and baseline stratum.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% CI for the odds ratio are obtained from the CMH tests controlling for geographic region and baseline stratum.|||4.20|1.58|< 0.0001
70897594|NCT02291679|141283212|SUPERIORITY||Odds Ratio (OR)|2.15||||0.0002|TWO_SIDED|95.0|1.42|3.26||P-value is obtained from the CMH tests controlling for geographic region and baseline stratum.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% CI for the odds ratio are obtained from the CMH tests controlling for geographic region and baseline stratum.|||3.26|1.42|0.0002
70897595|NCT02291679|141283213|SUPERIORITY||Odds Ratio (OR)|1.49||||0.0342|TWO_SIDED|95.0|1.03|2.17||P-value is obtained from the CMH tests controlling for geographic region and baseline stratum.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% CI for the odds ratio are obtained from the CMH tests controlling for geographic region and baseline stratum.|||2.17|1.03|0.0342
70897596|NCT02291679|141283214|SUPERIORITY||LS Mean Difference|-0.319||||0.0063|TWO_SIDED|95.0|-0.548|-0.09||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a LS mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|||-0.090|-0.548|0.0063
70897597|NCT02291679|141283215|SUPERIORITY||LS Mean Difference|-0.178||||0.1028|TWO_SIDED|95.0|-0.391|0.036||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a LS mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|||0.036|-0.391|0.1028
70897598|NCT02291679|141283216|SUPERIORITY||Odds Ratio (OR)|2.78||||0.0001|TWO_SIDED|95.0|1.61|4.8||P-value is obtained from the CMH tests controlling for baseline SBM stratum and geographic region.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% CI for the odds ratio are obtained from the CMH tests controlling for baseline SBM stratum and geographic region.|||4.80|1.61|0.0001
70897599|NCT02048072|141283217|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 1 sided|||||||0.02
70897600|NCT04450108|141283218|SUPERIORITY|The change of FeNO values will be estimated in ANCOVA with baseline values as the covariable and will be reported as percent change together with the 95%-confidence interval.|||||<|0.001|||||||ANCOVA|||Since the effect size of the change (mean change / standard deviation) is on the order of 1 (resulting in N=10 and 13 for power = 80% and 90%, respectively) and therefore large, the sample size is not determined by the primary objective but by the necessity to achieve representative data of FeNO measurement data over all age groups, measurement ranges (\<, ≥ cut off) and sites. Thus, 120 subjects will be recruited.||||<0.001
70897601|NCT01031810|141283229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.56|STANDARD_DEVIATION|10.81||0.012|TWO_SIDED|95.0|3.25|19.86|||paired t-test 2 sided|||Compare the mean differences between baseline (week00) and week12 hamd17 summary scores||19.86|3.25|0.012
70897602|NCT05338333|141283272|NON_INFERIORITY|Noninferiority in distance VA was declared if the least squares means difference upper confidence limit was less than 0.05.|Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.006|||ONE_SIDED|95.0||0.0||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, visit, lens-by-visit interaction, period, sequence, and habitual lens stratum) and random (subject) effects. Difference = LID210464 minus AOHG MF.|||0.00||
70897603|NCT05878197|141283277|OTHER|||||||0.024||||||Linear Mixed Models: time-effect|Mixed Models Analysis|||||||0.024
70897604|NCT05878197|141283277|OTHER|||||||0.822||||||Linear mixed models: group-effect|Mixed Models Analysis|||||||0.822
70897605|NCT05878197|141283277|OTHER|||||||0.29||||||Linar mixed models: time\*group-effect|Mixed Models Analysis|||||||0.290
70897606|NCT05878197|141283277|OTHER||Mean Difference (Final Values)|1.8||||0.035|TWO_SIDED|95.0|0.1|3.4||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||3.4|0.1|0.035
70897607|NCT05878197|141283277|OTHER||Mean Difference (Final Values)|1.8||||0.038|TWO_SIDED|95.0|0.1|3.4||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||3.4|0.1|0.038
70897608|NCT05878197|141283277|OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-1.9|1.9||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||1.9|-1.9|1.000
70897609|NCT05878197|141283278|OTHER|||||||0.107||||||Linear mixed models: time-effect|Mixed Models Analysis|||||||0.107
70897610|NCT05878197|141283278|OTHER|||||||0.996||||||Linear mixed models: group-effect|Mixed Models Analysis|||||||0.996
70897611|NCT05878197|141283278|OTHER|||||||0.639||||||Linear mixed models: time\*group-effect|Mixed Models Analysis|||||||0.639
70897612|NCT05878197|141283278|OTHER||Mean Difference (Final Values)|-0.1||||0.731|TWO_SIDED|95.0|-0.6|0.4||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||0.4|-0.6|0.731
70897613|NCT05878197|141283278|OTHER||Mean Difference (Final Values)|-0.4||||0.217|TWO_SIDED|95.0|-1.1|0.3||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||0.3|-1.1|0.217
70897614|NCT05878197|141283278|OTHER||Mean Difference (Final Values)|-0.3||||0.253|TWO_SIDED|95.0|-0.9|0.3||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||0.3|-0.9|0.253
70897615|NCT05878197|141283279|OTHER|||||||0.024||||||Linear mixed models: time-effect|Mixed Models Analysis|||||||0.024
70897616|NCT05878197|141283279|OTHER|||||||0.449||||||Linear mixed models: group-effect|Mixed Models Analysis|||||||0.449
70897617|NCT05878197|141283279|OTHER|||||||0.786||||||Linear mixed models: time\*group-effect|Mixed Models Analysis|||||||0.786
70897618|NCT05878197|141283279|OTHER||Mean Difference (Final Values)|-3.3||||0.099|TWO_SIDED|95.0|-7.2|0.7||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||0.7|-7.2|0.099
70897619|NCT05878197|141283279|OTHER||Mean Difference (Final Values)|-3.9||||0.074|TWO_SIDED|95.0|-8.3|0.4||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||0.4|-8.3|0.074
70897620|NCT05878197|141283279|OTHER||Mean Difference (Final Values)|-1.7||||0.472|TWO_SIDED|95.0|-6.7|3.2||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||3.2|-6.7|0.472
70897621|NCT05878197|141283280|OTHER|||||||0.115||||||Linear mixed models: time-effect|Mixed Models Analysis|||||||0.115
70897622|NCT05878197|141283280|OTHER|||||||0.516||||||Linear mixed models: group-effect|Mixed Models Analysis|||||||0.516
70897623|NCT05878197|141283280|OTHER|||||||0.276||||||Linear mixed models: time\*group-effect|Mixed Models Analysis|||||||0.276
70897624|NCT05878197|141283280|OTHER||Mean Difference (Final Values)|-6.5||||0.025|TWO_SIDED|95.0|-12.2|-0.9||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||-0.9|-12.2|0.025
70897625|NCT05878197|141283280|OTHER||Mean Difference (Final Values)|-0.7||||0.794|TWO_SIDED|95.0|-6.4|4.9||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||4.9|-6.4|0.794
70897626|NCT05878197|141283280|OTHER||Mean Difference (Final Values)|-1.0||||0.76|TWO_SIDED|95.0|-7.7|5.7||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||5.7|-7.7|0.760
70897627|NCT04295005|141283298|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Total cost comparison.||||< 0.001
70897628|NCT04295005|141283298|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Total cost comparison.||||< 0.001
70897629|NCT04295005|141283298|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Total cost comparison.||||< 0.001
70897630|NCT04295005|141283298|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Inpatient cost comparison||||< 0.001
70897631|NCT04295005|141283298|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Inpatient cost comparison.||||< 0.001
70897632|NCT04295005|141283298|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.||||||0.126|||||||Bang and Tsiatis|||Inpatient cost comparison||||0.126
70897633|NCT04295005|141283298|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Outpatient cost comparison.||||< 0.001
70897634|NCT04295005|141283298|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Outpatient cost comparison.||||< 0.001
70897635|NCT04295005|141283298|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Outpatient cost comparison.||||< 0.001
70897636|NCT04295005|141283298|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Medication cost comparison.||||< 0.001
70897637|NCT04295005|141283298|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Medication cost comparison.||||< 0.001
70897638|NCT04295005|141283298|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Medication cost comparison.||||< 0.001
70897639|NCT00428090|141283304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.074|TWO_SIDED|95.0|-3.8|0.2||Comparison between Placebo and RSG XR 2 mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.2|-3.8|0.074
70897640|NCT00428090|141283304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.338|TWO_SIDED|95.0|-3.0|1.0||Comparison between Placebo and RSG XR 8 mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.0|-3.0|0.338
70897641|NCT00428090|141283304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.602|TWO_SIDED|95.0|-3.5|2.1||Comparison between Placebo and Donepezil 10mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.1|-3.5|0.602
70897642|NCT00428090|141283305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.131|TWO_SIDED|95.0|-2.7|0.4||Comparison between Placebo and RSG XR 2 mg in All except e4/e4's cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.4|-2.7|0.131
70897643|NCT00428090|141283305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.315|TWO_SIDED|95.0|-2.4|0.8||Comparison between Placebo and RSG XR 8 mg in All except e4/e4's cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.8|-2.4|0.315
70897644|NCT00428090|141283305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.105|TWO_SIDED|95.0|-3.5|0.3||Comparison between Placebo and Donepezil 10 mg in All except e4/e4's cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.3|-3.5|0.105
70897645|NCT00428090|141283306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.272|TWO_SIDED|95.0|-2.2|0.6||Comparison between Placebo and RSG XR 2 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.6|-2.2|0.272
70897646|NCT00428090|141283306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.297|TWO_SIDED|95.0|-2.2|0.7||Comparison between Placebo and RSG XR 8 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.7|-2.2|0.297
70897647|NCT00428090|141283306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.131|TWO_SIDED|95.0|-3.1|0.4||Comparison between Placebo and Donepezil 10 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix||||0.4|-3.1|0.131
70897648|NCT00428090|141283307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.663|TWO_SIDED|95.0|-0.3|0.4||Comparison between Placebo and RSG XR 2 mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.4|-0.3|0.663
70897649|NCT00428090|141283307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.891|TWO_SIDED|95.0|-0.4|0.3||Comparison between Placebo and RSG XR 8 mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.3|-0.4|0.891
70897650|NCT00428090|141283307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.414|TWO_SIDED|95.0|-0.7|0.3||Comparison between Placebo and Donepezil 10 mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|||0.3|-0.7|0.414
70897651|NCT00428090|141283308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.913|TWO_SIDED|95.0|-0.3|0.3||Comparison between Placebo and RSG XR 2 mg in All except e4/e4's cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix||||0.3|-0.3|0.913
70897652|NCT00428090|141283308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.276|TWO_SIDED|95.0|-0.4|0.1||Comparison between Placebo and RSG XR 8 mg in All except e4/e4's cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.1|-0.4|0.276
70897653|NCT00428090|141283308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.025|TWO_SIDED|95.0|-0.8|-0.1||Comparison between Placebo and Donepezil 10 mg in All except e4/e4's cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||-0.1|-0.8|0.025
70897654|NCT00428090|141283309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.939|TWO_SIDED|95.0|-0.2|0.3||Comparison between Placebo and RSG XR 2 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.3|-0.2|0.939
70897655|NCT00428090|141283309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.307|TWO_SIDED|95.0|-0.4|0.1||Comparison between Placebo and RSG XR 8 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.1|-0.4|0.307
70897656|NCT00428090|141283309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.009|TWO_SIDED|95.0|-0.8|-0.1||Comparison between Placebo and Donepezil 10 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||-0.1|-0.8|0.009
70897657|NCT00428090|141283310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.116|TWO_SIDED|95.0|-2.0|0.2||Comparison between Placebo and RSG XR 2 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.2|-2.0|0.116
70897658|NCT00428090|141283310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.816|TWO_SIDED|95.0|-0.9|1.2||Comparison between Placebo and RSG XR 8 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.2|-0.9|0.816
70897659|NCT00428090|141283310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.318|TWO_SIDED|95.0|-2.1|0.7||Comparison between Placebo and Donepezil 10 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.7|-2.1|0.318
70897660|NCT00428090|141283310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.839|TWO_SIDED|95.0|-1.1|1.3||Comparison between Placebo and RSG XR 2 mg in at Week 16 Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.3|-1.1|0.839
70897661|NCT00428090|141283310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.165|TWO_SIDED|95.0|-0.3|2.0||Comparison between Placebo and RSG XR 8 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.0|-0.3|0.165
70897662|NCT00428090|141283310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.073|TWO_SIDED|95.0|-3.4|0.2||Comparison between Placebo and Donepezil 10 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.2|-3.4|0.073
70897663|NCT00428090|141283310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.272|TWO_SIDED|95.0|-2.2|0.6||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.6|-2.2|0.272
70897664|NCT00428090|141283310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.297|TWO_SIDED|95.0|-2.2|0.7||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.7|-2.2|0.297
70897665|NCT00428090|141283310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.131|TWO_SIDED|95.0|-3.1|0.4||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.4|-3.1|0.131
70897666|NCT00428090|141283311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.133|TWO_SIDED|95.0|-0.3|0.0||Comparison between Placebo and RSG XR 2 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.0|-0.3|0.133
70897667|NCT00428090|141283311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.958|TWO_SIDED|95.0|-0.2|0.2||Comparison between Placebo and RSG XR 8 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.2|-0.2|0.958
70897668|NCT00428090|141283311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.085|TWO_SIDED|95.0|-0.5|0.0||Comparison between Placebo and Donepezil 10 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.0|-0.5|0.085
70897669|NCT00428090|141283311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.102|TWO_SIDED|95.0|-0.4|0.0||Comparison between Placebo and RSG XR 2 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.0|-0.4|0.102
70897670|NCT00428090|141283311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.38|TWO_SIDED|95.0|-0.3|0.1||Comparison between Placebo and RSG XR 8 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.1|-0.3|0.380
70897671|NCT00428090|141283311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.006|TWO_SIDED|95.0|-0.7|-0.1||Comparison between Placebo and Donepezil 10 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||-0.1|-0.7|0.006
70897672|NCT00428090|141283311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.939|TWO_SIDED|95.0|-0.2|0.3||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.3|-0.2|0.939
70897673|NCT00428090|141283311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.307|TWO_SIDED|95.0|-0.4|0.1||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.1|-0.4|0.307
70897674|NCT00428090|141283311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.009|TWO_SIDED|95.0|-0.8|-0.1||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||-0.1|-0.8|0.009
70897675|NCT00428090|141283312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.957|TWO_SIDED|95.0|-1.6|1.5||Comparison between Placebo and RSG XR 2mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.5|-1.6|0.957
70897676|NCT00428090|141283312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.693|TWO_SIDED|95.0|-1.4|2.2||Comparison between Placebo and RSG XR 8 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.2|-1.4|0.693
70897677|NCT00428090|141283312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.798|TWO_SIDED|95.0|-2.2|1.7||Comparison between Placebo and Donepezil 10 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.7|-2.2|0.798
70897678|NCT00428090|141283312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.958|TWO_SIDED|95.0|-1.7|1.8||Comparison between Placebo and RSG XR 2 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.8|-1.7|0.958
70897679|NCT00428090|141283312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.998|TWO_SIDED|95.0|-2.1|2.1||Comparison between Placebo and RSG XR 8 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.1|-2.1|0.998
70897680|NCT00428090|141283312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.639||95.0|-1.7|2.8||Comparison between Placebo and Donepezil 10 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.8|-1.7|0.639
70897681|NCT00428090|141283312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.797|TWO_SIDED|95.0|-2.1|2.7||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.7|-2.1|0.797
70897682|NCT00428090|141283312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.942|TWO_SIDED|95.0|-2.9|2.7||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.7|-2.9|0.942
70897683|NCT00428090|141283312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.213|TWO_SIDED|95.0|-4.8|1.1||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.1|-4.8|0.213
70897684|NCT00428090|141283313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.919|TWO_SIDED|95.0|-2.1|2.3||Comparison between Placebo and RSG XR 2 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.3|-2.1|0.919
70897685|NCT00428090|141283313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.649|TWO_SIDED|95.0|-1.5|2.4||Comparison between Placebo and RSG XR 8 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.4|-1.5|0.649
70897686|NCT00428090|141283313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.279|TWO_SIDED|95.0|-1.1|3.6||Comparison between Placebo and Donepezil 10 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||3.6|-1.1|0.279
70897687|NCT00428090|141283313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.498|TWO_SIDED|95.0|-1.8|3.6||Comparison between Placebo and RSG XR 2 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||3.6|-1.8|0.498
70897688|NCT00428090|141283313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.489|TWO_SIDED|95.0|-1.7|3.6||Comparison between Placebo and RSG XR 8 mg in at Week 16 Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||3.6|-1.7|0.489
70897689|NCT00428090|141283313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7||||0.024|TWO_SIDED|95.0|0.5|7.0||Comparison between Placebo and Donepezil 10 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||7.0|0.5|0.024
70897690|NCT00428090|141283313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.385|TWO_SIDED|95.0|-1.6|4.2||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||4.2|-1.6|0.385
70897691|NCT00428090|141283313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.944|TWO_SIDED|95.0|-3.0|2.8||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.8|-3.0|0.944
70897692|NCT00428090|141283313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6||||0.078|TWO_SIDED|95.0|-0.4|7.5||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||7.5|-0.4|0.078
70897693|NCT00428090|141283314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.635|TWO_SIDED|95.0|-0.8|0.5||Comparison between Placebo and RSG XR 2 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.5|-0.8|0.635
70897694|NCT00428090|141283314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.194|TWO_SIDED|95.0|-0.2|1.1||Comparison between Placebo and RSG XR 8 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.1|-0.2|0.194
70897695|NCT00428090|141283314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.325|TWO_SIDED|95.0|-1.3|0.4||Comparison between Placebo and Donepezil 10 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.4|-1.3|0.325
70897696|NCT00428090|141283314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.109|TWO_SIDED|95.0|-0.1|1.2||Comparison between Placebo and RSG XR 2 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.2|-0.1|0.109
70897697|NCT00428090|141283314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.032|TWO_SIDED|95.0|0.1|1.4||Comparison between Placebo and RSG XR 8 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.4|0.1|0.032
70897698|NCT00428090|141283314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.189|TWO_SIDED|95.0|-1.7|0.3||Comparison between Placebo and Donepezil 10 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.3|-1.7|0.189
70897699|NCT00428090|141283314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.288|TWO_SIDED|95.0|-1.1|0.3||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.3|-1.1|0.288
70897700|NCT00428090|141283314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.819|TWO_SIDED|95.0|-0.8|0.6||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.6|-0.8|0.819
70897701|NCT00428090|141283314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.306|TWO_SIDED|95.0|-1.5|0.5||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.5|-1.5|0.306
70897702|NCT00428090|141283315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.199|TWO_SIDED|95.0|-0.01|0.07||Comparison between Placebo and RSG XR 2 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.07|-0.01|0.199
70897703|NCT00428090|141283315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.094|TWO_SIDED|95.0|-0.01|0.08||Comparison between Placebo and RSG XR 8 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.08|-0.01|0.094
70897704|NCT00428090|141283315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.187|TWO_SIDED|95.0|-0.02|0.09||Comparison between Placebo and Donepezil 10 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.09|-0.02|0.187
70897705|NCT00428090|141283315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.134|TWO_SIDED|95.0|-0.01|0.07||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.07|-0.01|0.134
70897706|NCT00428090|141283315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.958|TWO_SIDED|95.0|-0.05|0.05||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.05|-0.05|0.958
70897707|NCT00428090|141283315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.374|TWO_SIDED|95.0|-0.03|0.07||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.07|-0.03|0.374
70897708|NCT00428090|141283316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.493|TWO_SIDED|95.0|-4.6|2.2||Comparison between Placebo and RSG XR 2 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.2|-4.6|0.493
70897709|NCT00428090|141283316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.883|TWO_SIDED|95.0|-3.2|3.7||Comparison between Placebo and RSG XR 8 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||3.7|-3.2|0.883
70897710|NCT00428090|141283316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.13|TWO_SIDED|95.0|-9.3|1.2||Comparison between Placebo and Donepezil 10 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.2|-9.3|0.130
70897711|NCT00428090|141283316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.198|TWO_SIDED|95.0|-6.6|1.4||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.4|-6.6|0.198
70897712|NCT00428090|141283316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.441|TWO_SIDED|95.0|-5.9|2.6||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.6|-5.9|0.441
70897713|NCT00428090|141283316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.898|TWO_SIDED|95.0|-5.8|5.1||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||5.1|-5.8|0.898
70897714|NCT00428090|141283318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.027|TWO_SIDED|95.0|-2.1|-0.1||Comparison between Placebo and RSG XR 2 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||-0.1|-2.1|0.027
70897715|NCT00428090|141283318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.278|TWO_SIDED|95.0|-1.6|0.5||Comparison between Placebo and RSG XR 8 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.5|-1.6|0.278
70897716|NCT00428090|141283318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.993|TWO_SIDED|95.0|-1.2|1.1||Comparison between Placebo and Donepezil 10 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.1|-1.2|0.993
70897717|NCT00428090|141283318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.196|TWO_SIDED|95.0|-2.0|0.4||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.4|-2.0|0.196
70897718|NCT00428090|141283318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.353|TWO_SIDED|95.0|-1.9|0.7||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.7|-1.9|0.353
70897719|NCT00428090|141283318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.427|TWO_SIDED|95.0|-2.2|0.9||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.9|-2.2|0.427
70897720|NCT00428090|141283319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.886|TWO_SIDED|95.0|-0.7|0.6|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.6|-0.7|0.886
70897721|NCT00428090|141283319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.71|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.6|-0.8|0.710
70897722|NCT00428090|141283319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.03|TWO_SIDED|95.0|0.1|1.8|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.8|0.1|0.030
70897723|NCT00428090|141283320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.139|TWO_SIDED|95.0|0.0|0.2|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.2|-0.0|0.139
70897724|NCT00428090|141283320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.846|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.1|-0.1|0.846
70897725|NCT00428090|141283320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.864|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.2|-0.1|0.864
70897726|NCT00863655|141283348|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43|||<|0.0001|TWO_SIDED|95.0|0.35|0.54|||Log Rank|||||0.54|0.35|<0.0001
70897727|NCT02157779|141283360|SUPERIORITY||Least Squares Mean Difference|-5.68||||0.017|TWO_SIDED|95.0|-10.32|-1.01||Threshold for statistical significance was 0.025.|ANCOVA|Method used: Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (4wk, 8wk, end of treatment, 3 mo f/u, and/or 6 mo f/u) were used in the HLM analyses.||-1.01|-10.32|.017
70897728|NCT02157779|141283361|SUPERIORITY||Least Squares Mean Difference|-0.14||||0.19|TWO_SIDED|95.0|-0.33|0.06||The threshold for statistical significance was p=0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.||Population Description: All randomized participants with at least one post-baseline assessment (4wk, 8wk, end of treatment, 3 mo f/u, and/or 6 mo f/u) were used in the statistical analysis. Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|0.06|-0.33|0.19
70897729|NCT02157779|141283362|SUPERIORITY||Least Squares Mean Difference|-0.42||||0.011|TWO_SIDED|95.0|-0.75|-0.09||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score||Population Description: All randomized participants with at least one post-baseline assessment were used in the statistical analysis process.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|-0.09|-0.75|.011
70897730|NCT02157779|141283363|SUPERIORITY||Least Squares Mean Difference|-0.26||||0.16|TWO_SIDED|95.0|-0.63|0.11||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (12 weeks (end of treatment, 3 month and/or 6 month follow-up) were included in the analyses.||0.11|-0.63|0.16
70897731|NCT02157779|141283364|SUPERIORITY||Least Squares Mean Difference|-11.65||||0.031|TWO_SIDED|95.0|-22.2|-1.09||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (12 weeks (end of treatment), 3 month and/or 6 month follow-up) were included in the statistical analyses.||-1.09|-22.20|.031
70897732|NCT02157779|141283365|SUPERIORITY||Least Squares Mean Difference|1.56||||0.004|TWO_SIDED|95.0|0.51|2.6||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.||All randomized participants with at least one post-baseline assessment (week 12 (end of treatment), 3 month, and/or 6 month follow-up) were used in the statistical analysis.|A positive difference means that the adjusted mean for CBI is numerically higher than that for SI.|2.60|0.51|0.004
70897733|NCT02157779|141283366|SUPERIORITY||Least Squares Mean Difference|-2.15||||0.416|TWO_SIDED|95.0|-7.37|3.07||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI|All randomized participants with at least one post-baseline assessment were used in the statistical analysis process.||3.07|-7.37|0.416
70897734|NCT02157779|141283367|SUPERIORITY||Least Squares Mean Difference|-13.72||||0.028|TWO_SIDED|95.0|-25.94|-1.5||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment were used in the analyses.||-1.50|-25.94|0.028
70897735|NCT02157779|141283368|SUPERIORITY|||||||0.13|||||||ANOVA|GLM Repeated Measures Analysis of Variance of means grouped by sessions 1-4, 5-8, and 9-12||All randomized participants with at least one DAR completed in each time frame (sessions 1-4, 5-8, and 9-12) were included in the analyses. The mean DAR scores for sessions 1-4, 5-8, and 9-12 were calculated and used as outcome variables in the GLM repeated measures ANOVA.||||0.13
70897736|NCT02157779|141283369|SUPERIORITY||Least Squares Mean Difference|-0.82||||0.03|TWO_SIDED|95.0|-1.578|-0.063||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (week 4, week 8, week 12 (end of treatment), 3 mo and/or 6 month follow-up) were included in the HLM analyses.||-0.063|-1.578|0.030
70897737|NCT02157779|141283370|SUPERIORITY||Least Squares Mean Difference|-0.085||||0.021|TWO_SIDED|95.0|-0.158|-0.011||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|"All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were included in the HLM analysis.~Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data."||-0.011|-0.158|0.021
70897738|NCT02157779|141283371|SUPERIORITY||Least Squares Mean Difference|-0.1||||0.246|TWO_SIDED|95.0|-0.283|0.073||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were used in the HLM analysis. Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data.||0.073|-0.283|0.246
70897739|NCT02157779|141283372|SUPERIORITY||Least Squares Mean Difference|-0.14||||0.036|TWO_SIDED|95.0|-0.27|-0.01||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment were used in the statistical analysis. Data were winsorized and log 10 transformed to counter high levels of skewness.||-0.01|-0.27|0.036
70897740|NCT02157779|141283373|SUPERIORITY||Least Squares Mean Difference|-0.026||||0.786|TWO_SIDED|95.0|-0.213|0.1614||Threshold for statistical significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|"All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were included in the HLM analysis.~Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data."||0.1614|-0.213|0.786
70897741|NCT02157779|141283374|SUPERIORITY||Least Squares Mean Difference|-0.02||||0.744|TWO_SIDED|95.0|-0.18|0.13||Threshold for significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|"All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were included in the HLM analysis.~Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data."||0.13|-0.18|0.744
70897742|NCT02157779|141283375|SUPERIORITY||Least Squares Mean Difference|-1.85||||0.002|TWO_SIDED|95.0|-3.038|-0.663||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were included in the HLM analysis. Full Information Maximum Likelihood was used to account for missing data.||-0.663|-3.038|0.002
70897743|NCT02157779|141283376|SUPERIORITY||Least Squares Mean Difference|-1.0||||0.186|TWO_SIDED|95.0|-2.518|0.524||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (4wk, 8wk, 12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis. Full Information Maximum Likelihood was used to account for missing data.||0.524|-2.518|0.186
70897744|NCT02157779|141283377|SUPERIORITY||Least Squares Mean Difference|1.26||||0.164|TWO_SIDED|95.0|-0.56|3.09||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A positive difference means that the adjusted mean for CBI is numerically higher than that for SI.|"All randomized participants with at least one post-baseline assessment (4wk, 8wk, 12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.~Full Information Maximum Likelihood was used to account for missing data."||3.09|-0.560|0.164
70897745|NCT02157779|141283378|SUPERIORITY||Least Squares Mean Difference|1.33||||0.1|TWO_SIDED|95.0|-0.26|2.92||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score|A positive difference means that the adjusted mean for CBI is numerically higher than that for SI.|"All randomized participants with at least one post-baseline assessment (4wk, 8wk, 12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.~Full Information Maximum Likelihood was used to account for missing data."||2.92|-0.26|0.100
70897746|NCT02157779|141283379|SUPERIORITY||Least Squares Mean Difference|-6.29||||0.06|TWO_SIDED|95.0|-12.85|0.27||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.||"All randomized participants with at least one post-baseline assessment (12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.~Full Information Maximum Likelihood was used to account for missing data."|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI, indicating less symptomatic distress.|0.27|-12.85|0.060
70897747|NCT02157779|141283380|SUPERIORITY||Least Squares Mean Difference|-3.271||||0.023|TWO_SIDED|95.0|-6.083|-0.458||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|"All randomized participants with at least one post-baseline assessment (12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.~Full Information Maximum Likelihood was used to account for missing data."||-0.458|-6.083|0.023
70897748|NCT02157779|141283381|SUPERIORITY||Least Squares Mean Difference|-1.28||||0.23|TWO_SIDED|95.0|-3.39|0.82||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|"All randomized participants with at least one post-baseline assessment (12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.~Full Information Maximum Likelihood was used to account for missing data."||0.82|-3.39|0.23
70897749|NCT00430248|141283385|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of febuxostat 40 mg to allopurinol was declared if the value of the lower bound of the 95% confidence interval for the difference was greater than -10%.|Difference in percentage|3.1||||||95.0|-1.9|8.1||||||The primary comparison was between febuxostat 40 mg and allopurinol treatment groups.||8.1|-1.9|
70897750|NCT00430248|141283385|SUPERIORITY_OR_OTHER|||||||0.233||95.0||||The test for superiority was performed using Fisher's exact test (two-tailed 0.05 significance level).|Fisher Exact|||||||0.233
70897751|NCT00430248|141283385|SUPERIORITY_OR_OTHER||Difference in percentage|24.9|||<|0.001||95.0|20.1|29.8||Comparisons between treatment groups were performed using Fisher's exact test (two-tailed 0.05 significance level).|Fisher Exact|||||29.8|20.1|<0.001
70897752|NCT00430248|141283385|SUPERIORITY_OR_OTHER||Difference in percentage|21.9|||<|0.001||95.0|17.0|26.8||Comparisons between treatment groups were performed using Fisher's exact test (two-tailed 0.05 significance level).|Fisher Exact|||||26.8|17.0|<0.001
70897753|NCT00430248|141283386|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.021
70897754|NCT00430248|141283386|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
70897755|NCT00430248|141283386|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
70897756|NCT00430248|141283387|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.031
70897757|NCT00430248|141283387|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
70897758|NCT00430248|141283387|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
70897759|NCT00430248|141283388|SUPERIORITY_OR_OTHER|||||||0.578||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.578
70897760|NCT00430248|141283388|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
70897761|NCT00430248|141283388|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
70897762|NCT00430248|141283389|SUPERIORITY_OR_OTHER|||||||0.426||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.426
70897763|NCT00430248|141283389|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
70897764|NCT00430248|141283389|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
70897765|NCT00430248|141283390|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.050
70897766|NCT00430248|141283390|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
70897767|NCT00430248|141283390|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
70897768|NCT00430248|141283391|SUPERIORITY_OR_OTHER|||||||0.428||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.428
70897769|NCT00430248|141283391|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
70897770|NCT00430248|141283391|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
70897771|NCT00430248|141283392|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.041
70897772|NCT00430248|141283392|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
70897773|NCT00430248|141283392|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
70897774|NCT00430248|141283393|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.083
70897775|NCT00430248|141283393|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
70897776|NCT00430248|141283393|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
70897777|NCT00430248|141283394|SUPERIORITY_OR_OTHER|||||||0.421||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.421
70897778|NCT00430248|141283394|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
70897779|NCT00430248|141283394|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
70897780|NCT00430248|141283395|SUPERIORITY_OR_OTHER|||||||0.52||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.520
70897781|NCT00430248|141283395|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
70897782|NCT00430248|141283395|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
70897783|NCT00430248|141283396|SUPERIORITY_OR_OTHER|||||||0.195||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.195
70897784|NCT00430248|141283396|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
70897785|NCT00430248|141283396|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
70897786|NCT00430248|141283397|SUPERIORITY_OR_OTHER|||||||0.196||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.196
70897787|NCT00430248|141283397|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
70897788|NCT00430248|141283397|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
70897789|NCT00430248|141283398|SUPERIORITY_OR_OTHER|||||||0.079||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||0.079
70897790|NCT00430248|141283398|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
70897791|NCT00430248|141283398|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
70897792|NCT00430248|141283399|SUPERIORITY_OR_OTHER|||||||0.685||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||0.685
70897793|NCT00430248|141283399|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
70897794|NCT00430248|141283399|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
70897795|NCT00430248|141283400|SUPERIORITY_OR_OTHER|||||||0.153||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||0.153
70897796|NCT00430248|141283400|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
70897797|NCT00430248|141283400|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
70897798|NCT00430248|141283401|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||0.050
70897799|NCT00430248|141283401|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
70897800|NCT00430248|141283401|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
70897801|NCT02249819|141283402|EQUIVALENCE|Statistical analysis for mean change from baseline in naming accuracy in the anodal vs. sham tDCS conditions Null hypothesis is that there was no difference in mean change of naming accuracy between anodal and sham tDCS conditions. A significance level of 0.05 was used (two-sided).||||||0.694||||||The wilcoxon sign-ranked test was performed for this crossover design study in which subjects underwent measures across 2 study conditions (paired samples: mean change in anodal vs. sham condition). A significance level of 0.05 was used (two-sided).|wilcoxon sign-ranked test|Western Aphasia Battery used as a screening tool on admission only, to characterize level of severity. It was NOT an outcome measure.||||||0.694
70897802|NCT00677235|141283440|SUPERIORITY_OR_OTHER|||||||0.449|||||||Fisher Exact|||||||0.449
70897803|NCT04570436|141283451|SUPERIORITY||Mean Difference (Final Values)|30.9|STANDARD_ERROR_OF_MEAN|2.85|<|0.0001|ONE_SIDED|95.0|26.2||||Mixed Models Analysis|||"The sensitivity and integrity of the study was validated by comparing the mean responses of diazepam, the positive control (C), to the placebo (P):~H0: μC - μP ≤ δ1 versus Ha: μC - μP \> δ1 where δ1 = 15"|||26.2|<0.0001
70897804|NCT04570436|141283451|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|10.0|STANDARD_ERROR_OF_MEAN|2.84||0.3581|ONE_SIDED|95.0||14.7|||Mixed Models Analysis|||"The primary analysis evaluated whether gabapentin (T) produced mean responses that show abuse potential similar to placebo.~H0: μT - μP ≥ δ3 versus Ha: μT - μP \< δ3 where δ3 =11"||14.7||0.3581
70897805|NCT04570436|141283451|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|9.5|STANDARD_ERROR_OF_MEAN|2.85||0.3051|ONE_SIDED|95.0||14.3|||Mixed Models Analysis|||"The primary analysis evaluated whether gabapentin (T) produced mean responses that show abuse potential similar to placebo.~H0: μT - μP ≥ δ3 versus Ha: μT - μP \< δ3 where δ3 =11"||14.3||0.3051
70897806|NCT04570436|141283451|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|8.8|STANDARD_ERROR_OF_MEAN|2.83||0.2179|ONE_SIDED|95.0||13.5|||Mixed Models Analysis|||"The primary analysis evaluated whether gabapentin (T) produced mean responses that show abuse potential similar to placebo.~H0: μT - μP ≥ δ3 versus Ha: μT - μP \< δ3 where δ3 =11"||13.5||0.2179
70897807|NCT04570436|141283451|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|20.9|STANDARD_ERROR_OF_MEAN|2.84|<|0.0001|ONE_SIDED|95.0|16.3||||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (T) produced mean responses that show less abuse potential than diazepam (C) were:~H0: μC - μT ≤ δ2 versus Ha: μC - μT \> δ2 where δ2 =0"|||16.3|<0.0001
70897808|NCT04570436|141283451|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|21.4|STANDARD_ERROR_OF_MEAN|2.84|<|0.0001|ONE_SIDED|95.0|16.7||||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (T) produced mean responses that show less abuse potential than diazepam (C) were:~H0: μC - μT ≤ δ2 versus Ha: μC - μT \> δ2 where δ2 =0"|||16.7|<0.0001
70897809|NCT04570436|141283451|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|22.1|STANDARD_ERROR_OF_MEAN|2.85|<|0.0001|ONE_SIDED|95.0|17.4||||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (T) produced mean responses that show less abuse potential than diazepam (C) were:~H0: μC - μT ≤ δ2 versus Ha: μC - μT \> δ2 where δ2 =0"|||17.4|<0.0001
70897810|NCT04570436|141283453|OTHER||Mean Difference (Final Values)|325.8|STANDARD_ERROR_OF_MEAN|113.38||0.0023|ONE_SIDED|90.0|138.2||||Mixed Models Analysis||||||138.2|0.0023
70897811|NCT04570436|141283453|OTHER||Mean Difference (Final Values)|140.5|STANDARD_ERROR_OF_MEAN|113.01||0.2157|TWO_SIDED|90.0|-82.7|363.7|||Mixed Models Analysis|||||363.7|-82.7|0.2157
70897812|NCT04570436|141283453|OTHER||Mean Difference (Final Values)|155.4|STANDARD_ERROR_OF_MEAN|113.25||0.172|TWO_SIDED|90.0|-68.3|379.1|||Mixed Models Analysis|||||379.1|-68.3|0.1720
70897813|NCT04570436|141283453|OTHER||Mean Difference (Final Values)|212.2|STANDARD_ERROR_OF_MEAN|113.01||0.0622|TWO_SIDED|90.0|-11.0|435.5|||Mixed Models Analysis|||||435.5|-11.0|0.0622
70897814|NCT04570436|141283453|OTHER||Mean Difference (Final Values)|-185.0|STANDARD_ERROR_OF_MEAN|113.04||0.1031|TWO_SIDED|90.0|-409.0|37.94|||Mixed Models Analysis|||||37.94|-409|0.1031
70897815|NCT04570436|141283453|OTHER||Mean Difference (Final Values)|-170.0|STANDARD_ERROR_OF_MEAN|112.97||0.1334|TWO_SIDED|90.0|-394.0|52.71|||Mixed Models Analysis|||||52.71|-394|0.1334
70897816|NCT04570436|141283453|OTHER||Mean Difference (Final Values)|-114.0|STANDARD_ERROR_OF_MEAN|113.59||0.3189|TWO_SIDED|90.0|-338.0|110.8|||Mixed Models Analysis|||||110.8|-338|0.3189
70897817|NCT04570436|141283454|OTHER||Mean Difference (Final Values)|55.77|STANDARD_ERROR_OF_MEAN|5.362|<|0.0001|ONE_SIDED|90.0|46.89||||Mixed Models Analysis||||||46.89|<0.0001
70897818|NCT04570436|141283454|OTHER||Mean Difference (Final Values)|17.18|STANDARD_ERROR_OF_MEAN|5.348||0.0016|TWO_SIDED|90.0|6.61|27.74|||Mixed Models Analysis|||||27.74|6.61|0.0016
70897819|NCT04570436|141283454|OTHER||Mean Difference (Final Values)|21.38|STANDARD_ERROR_OF_MEAN|5.36||0.0001|TWO_SIDED|90.0|10.79|31.96|||Mixed Models Analysis|||||31.96|10.79|0.0001
70897820|NCT04570436|141283454|OTHER||Mean Difference (Final Values)|22.5|STANDARD_ERROR_OF_MEAN|5.352|<|0.0001|TWO_SIDED|90.0|11.92|33.07|||Mixed Models Analysis|||||33.07|11.92|<0.0001
70897821|NCT04570436|141283454|OTHER||Mean Difference (Final Values)|-38.6|STANDARD_ERROR_OF_MEAN|5.312|<|0.0001|TWO_SIDED|90.0|-49.1|-28.1|||Mixed Models Analysis|||||-28.1|-49.1|<0.0001
70897822|NCT04570436|141283454|OTHER||Mean Difference (Final Values)|-34.4|STANDARD_ERROR_OF_MEAN|5.308|<|0.0001|TWO_SIDED|90.0|-44.9|-23.9|||Mixed Models Analysis|||||-23.9|-44.9|<0.0001
70897823|NCT04570436|141283454|OTHER||Mean Difference (Final Values)|-33.3|STANDARD_ERROR_OF_MEAN|5.337|<|0.0001|TWO_SIDED|90.0|-43.8|-22.7|||Mixed Models Analysis|||||-22.7|-43.8|<0.0001
70897824|NCT04570436|141283456|OTHER||Mean Difference (Final Values)|234.9|STANDARD_ERROR_OF_MEAN|38.174|<|0.0001|ONE_SIDED|90.0|171.7||||Mixed Models Analysis||||||171.7|<0.0001
70897825|NCT04570436|141283456|OTHER||Mean Difference (Final Values)|66.3|STANDARD_ERROR_OF_MEAN|38.048||0.0834|TWO_SIDED|90.0|-8.86|141.5|||Mixed Models Analysis|||||141.5|-8.86|0.0834
70897826|NCT04570436|141283456|OTHER||Mean Difference (Final Values)|99.06|STANDARD_ERROR_OF_MEAN|38.128||0.0103|TWO_SIDED|90.0|23.75|174.4|||Mixed Models Analysis|||||174.4|23.75|0.0103
70897827|NCT04570436|141283456|OTHER||Mean Difference (Final Values)|97.2|STANDARD_ERROR_OF_MEAN|38.048||0.0116|TWO_SIDED|90.0|22.05|172.4|||Mixed Models Analysis|||||172.4|22.05|0.0116
70897828|NCT04570436|141283456|OTHER||Mean Difference (Final Values)|-169.0|STANDARD_ERROR_OF_MEAN|38.06|<|0.0001|TWO_SIDED|90.0|-244.0|-93.4|||Mixed Models Analysis|||||-93.4|-244|<0.0001
70897829|NCT04570436|141283456|OTHER||Mean Difference (Final Values)|-136.0|STANDARD_ERROR_OF_MEAN|38.036||0.0005|TWO_SIDED|90.0|-211.0|-60.7|||Mixed Models Analysis|||||-60.7|-211|0.0005
70897830|NCT04570436|141283456|OTHER||Mean Difference (Final Values)|-138.0|STANDARD_ERROR_OF_MEAN|38.243||0.0004|TWO_SIDED|90.0|-213.0|-62.2|||Mixed Models Analysis|||||-62.2|-213|0.0004
70897831|NCT01274182|141283475|EQUIVALENCE|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.106|||||TWO_SIDED|90.0|1.01|1.21|||||GP2013 arm is the numerator and MabThera arm is the denominator|PK bioequivalence is defined as AUC(0-inf) of the drugs being comparable, i.e. the two-sided 90% CI for the ratio of the geometric means (GP2013/MabThera) is within the predefined bioequivalence limits of 0.8 to 1.25.||1.210|1.010|
70897832|NCT01274182|141283475|EQUIVALENCE|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.012|||||TWO_SIDED|90.0|0.925|1.108|||||GP2013 arm is the numerator and Rituxan arm is the denominator|PK bioequivalence is defined as AUC(0-inf) of the drugs being comparable, i.e. the two-sided 90% CI for the ratio of the geometric means (GP2013/MabThera) is within the predefined bioequivalence limits of 0.8 to 1.25.||1.108|0.925|
70897833|NCT01274182|141283475|EQUIVALENCE|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.093|||||TWO_SIDED|90.0|0.989|1.208|||||Rituxan arm is the numerator and MabThera arm is the denominator|PK bioequivalence is defined as AUC(0-inf) of the drugs being comparable, i.e. the two-sided 90% CI for the ratio of the geometric means (GP2013/MabThera) is within the predefined bioequivalence limits of 0.8 to 1.25.||1.208|0.989|
70897834|NCT01274182|141283476|EQUIVALENCE|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.076|||||TWO_SIDED|90.0|0.979|1.184|||||GP2013 arm is the numerator and Rituxan arm is the denominator|To conclude bioequivalence the 90% CI must be entirely within the standard equivalence limits of 0.8-1.25.||1.184|0.979|
70897835|NCT01274182|141283476|EQUIVALENCE|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.131|||||TWO_SIDED|90.0|1.027|1.244|||||GP2013 arm is the numerator and MabThera arm is the denominator|To conclude bioequivalence the 90% CI must be entirely within the standard equivalence limits of 0.8-1.25||1.244|1.027|
70897836|NCT01274182|141283476|EQUIVALENCE|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.05|||||TWO_SIDED|90.0|0.946|1.167|||||Rituxan arm is the numerator and MabThera arm is the denominator|To conclude bioequivalence the 90% CI must be entirely within the standard equivalence limits of 0.8-1.25.||1.167|0.946|
70897837|NCT01274182|141283477|EQUIVALENCE|Ratio of geometric means and 95% confidence interval were estimated by an analysis of variance (ANOVA) on log-transformed PD parameter with treatment as the factor. Results were then back-transformed to the original scale.|Geometric mean ratio|0.989|||||TWO_SIDED|95.0|0.974|1.004|||||GP2013 arm is the numerator and Rituxan arm is the denominator|To conclude equivalence the 95% CI must be entirely within the standard equivalencelimits of 0.8-1.25||1.004|0.974|
70897838|NCT01274182|141283477|EQUIVALENCE|Ratio of geometric means and 95% confidence interval were estimated by an analysis of variance (ANOVA) on log-transformed PD parameter with treatment as the factor. Results were then back-transformed to the original scale.|Geometric mean ratio|1.021|||||TWO_SIDED|95.0|1.003|1.04|||||GP2013 arm is the numerator and MabThera arm is the denominator|To conclude equivalence the 95% CI must be entirely within the standard equivalencelimits of 0.8-1.25||1.040|1.003|
70897839|NCT01274182|141283477|EQUIVALENCE|Ratio of geometric means and 95% confidence interval were estimated by an analysis of variance (ANOVA) on log-transformed PD parameter with treatment as the factor. Results were then back-transformed to the original scale.|Geometric mean ratio|1.033|||||TWO_SIDED|95.0|1.016|1.05|||||Rituxan arm is the numerator and MabThera arm is the denominator|To conclude equivalence the 95% CI must be entirely within the standard equivalence limits of 0.8-1.25||1.050|1.016|
70963634|NCT02273726|141432203|NON_INFERIORITY|Non-inferiority was established if the 2-sided 95% confidence interval (CI) for the treatment difference in least square (LS) means from MI ANCOVA model between the 2 treatment groups lay entirely above -0.75 g/dL.|LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.058|<|0.0001|TWO_SIDED|95.0|0.365|0.591|||ANCOVA|ANCOVA with MI||Treatment comparison was made using the multiple imputation (MI) strategy by combining the results of analysis of covariance (ANCOVA) model with baseline Hb as a covariate, and treatment, ESA dependent incident dialysis within ≤4 months vs. \>4 months of starting dialysis when randomized, and other randomization stratification factors except mean qualifying screening hemoglobin (≤10.5 vs. \>10.5 g/dL) as fixed effects.||0.591|0.365|<0.0001
70897840|NCT01274182|141283478|NON_INFERIORITY|"The non-inferiority margin is further justified by the EULAR criteria which define no response as change from baseline being \< 0.6.~LS means, standard errors and 95% CI were estimated by a repeated measures mixed model with treatment, time and treatment\*time interaction term as categorical variables and baseline DAS28 as a continuous variable.~A negative change from baseline represents an improvement in assessment of rheumatoid arthritis."|LS Mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.162|||TWO_SIDED|95.0|-0.397|0.24|||||The direction of comparison is LS mean of GP2013 - LS mean of Rituxan|To conclude non-inferiority the upper 95% CI should be less than or equal to 0.6. This margin was statistically justified by the results of the REFLEX (Randomized Evaluation of Long-Term Efficacy of Rituximab in RA) trial (Cohen et al 2006) providing a 95% CI for the mean difference between rituximab/MTX and MTX alone of (-1.74;-1.25). The margin of 0.6 was determined by retaining more than 50% of the reference treatment effect which was considered clinically acceptable.||0.240|-0.397|
70897841|NCT01274182|141283478|NON_INFERIORITY|"The non-inferiority margin is further justified by the EULAR criteria which define no response as change from baseline being \< 0.6. LS means, standard errors and 95% CI were estimated by a repeated measures mixed model with treatment, time and treatment\*time interaction term as categorical variables and baseline DAS28 as a continuous variable.~A negative change from baseline represents an improvement in assessment of rheumatoid arthritis."|LS Mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.201|||TWO_SIDED|95.0|-0.328|0.462|||||The direction of comparison is LS mean of GP2013 Part I - LS mean of MabThera|To conclude non-inferiority the upper 95% CI should be less than or equal to 0.6. This margin was statistically justified by the results of the REFLEX (Randomized Evaluation of Long-Term Efficacy of Rituximab in RA) trial (Cohen et al 2006) providing a 95% CI for the mean difference between rituximab/MTX and MTX alone of (-1.74;-1.25). The margin of 0.6 was determined by retaining more than 50% of the reference treatment effect which was considered clinically acceptable.||0.462|-0.328|
70897842|NCT01274182|141283479|NON_INFERIORITY|The predefined noninferiority margin of 0.15 for ACR20 is based on the historical placebo-controlled phase III study to evaluate the response rate benefit of adding rituximab to the conventional small molecule-based treatment of patients with RA (Cohen et al. 2006).|Response rate difference (%)|9.77|STANDARD_ERROR_OF_MEAN|6.79|||TWO_SIDED|95.0|-3.54|23.08|||||The direction of comparison is response rate of GP2013 - response rate of Rituxan|To conclude non-inferiority the lower 95% CI should be greater than -15.0%.||23.08|-3.54|
70897843|NCT01274182|141283479|NON_INFERIORITY|The predefined noninferiority margin of 0.15 for ACR20 is based on the historical placebo-controlled phase III study to evaluate the response rate benefit of adding rituximab to the conventional small molecule-based treatment of patients with RA (Cohen et al. 2006).|Response rate difference (%)|-0.57|STANDARD_ERROR_OF_MEAN|7.23|||TWO_SIDED|95.0|-14.74|13.6|||||The direction of comparison is response rate of GP2013 Part I - response rate of MabThera|To conclude non-inferiority the lower 95% CI should be greater than -15.0%.||13.60|-14.74|
70897844|NCT04322604|141283487|SUPERIORITY||Percent Difference from Placebo|80.1|||<|0.0001|TWO_SIDED|95.0|70.1|87.9|||Fisher Exact|||||87.9|70.1|<0.0001
70897845|NCT04322604|141283488|SUPERIORITY||LSM Difference from Placebo|1.5||||0.3427|TWO_SIDED|95.0|-1.6|4.7|||ANCOVA|||||4.7|-1.6|0.3427
70897846|NCT04322604|141283489|SUPERIORITY||LSM Difference from Placebo|-41.2|||<|0.0001|TWO_SIDED|95.0|-48.1|-34.2|||ANCOVA|||||-34.2|-48.1|<0.0001
70897847|NCT04322604|141283490|SUPERIORITY||Percent Difference from Placebo|81.3|||<|0.0001|TWO_SIDED|95.0|71.7|88.8|||Fisher Exact|||||88.8|71.7|<0.0001
70897848|NCT04322604|141283491|SUPERIORITY||Percent Difference from Placebo|39.5|||<|0.0001|TWO_SIDED|95.0|25.4|52.2|||Fisher Exact|||||52.2|25.4|<0.0001
70897849|NCT04322604|141283492|SUPERIORITY||Percent Difference from Placebo|7.0||||0.3549|TWO_SIDED|95.0|-7.4|21.6|||Fisher Exact|||||21.6|-7.4|0.3549
70897850|NCT04322604|141283493|SUPERIORITY||Percent Difference from Placebo|8.3||||0.2262|TWO_SIDED|95.0|-6.3|22.7|||Fisher Exact|||||22.7|-6.3|0.2262
70897851|NCT04322604|141283494|SUPERIORITY||LSM Difference from Placebo|5.0||||0.3812|TWO_SIDED|95.0|-6.1|16.0|||Mixed Models Analysis|||Week 24 Percent Change from Baseline||16.0|-6.1|0.3812
70897852|NCT03923959|141283527|SUPERIORITY||Odds Ratio (OR)|1.013|STANDARD_ERROR_OF_MEAN|0.307||0.966|TWO_SIDED|95.0|0.5597|1.834|||Regression, Logistic||||A two-sample proportion test was also completed; the test utilized an α \< 0.049 to account for the O'Brien-Fleming adjustment. The p-value for the two-sample proportion test was 0.966.|1.834|0.5597|0.966
70897853|NCT03923959|141283528|SUPERIORITY|||||||0.183||||||a priori threshold for statistical significance was the standard α = 0.05.|Chi-squared|||||||0.183
70897854|NCT03923959|141283529|SUPERIORITY|||||||0.729||||||a priori threshold for statistical significance was the standard α = 0.05.|Chi-squared|||||||0.729
70897855|NCT03923959|141283530|SUPERIORITY|||||||0.655||||||a priori threshold for statistical significance was the standard α = 0.05|Chi-squared|||||||0.655
70897856|NCT03923959|141283531|SUPERIORITY|||||||0.7832||||||a priori threshold for statistical significance was the standard α = 0.05.|t-test, 2 sided|||||||0.7832
70897857|NCT01375114|141283559|OTHER|||||||0.67|||||||Chi-squared|||||||0.67
70897858|NCT01375114|141283560|OTHER|||||||0.71|||||||Chi-squared|||||||0.71
70897859|NCT01375114|141283561|OTHER|||||||0.34|||||||Chi-squared|||||||0.34
70897860|NCT01375114|141283562|OTHER|||||||0.36|||||||Chi-squared|||||||0.36
70897861|NCT01375114|141283563|OTHER|||||||0.56|||||||Chi-squared|||||||0.56
70897862|NCT00715429|141283581|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27||||||Daily cramp rate at baseline\& on treatment, were calculated as % of each subjects total # of cramps, for comparison among subjects. Change in % cramp rates from baseline to treatment was computed for each subject in vit D and placebo groups.|t-test, 2 sided|T test was used to compare the change in % cramp rate from baseline to treatment for each subject in each treatment group.||||||0.27
70897863|NCT04085328|141283585|NON_INFERIORITY|Predefined margin of 0.05 for noninferiority|Difference in proportion|-0.0154|||||ONE_SIDED|95.0||-0.0015|||Generalized linear model|Proportion of events was analyzed using a generalized linear model, with a logit link function, accounting for within-subject correlation.|Difference in proportion = LID015385 minus Biofinity.|||-0.0015||
70897864|NCT00514735|141283586|SUPERIORITY_OR_OTHER||||||<|0.0001||||||In order to maintain the overall level of significance at the α=0.025 level after a planned interim analysis using α=0.003, this test will actually be performed using an adjusted α=0.0245 at the completion of the study.|Chi-squared|||"H0: Pa ≤ Pm Ha: Pa \> Pm~where Pa is the proportion of successfully treated subjects in the ablation management arm and Pm is the proportion of successfully treated subjects in the optimal medical management/drug therapy arm."||||<0.0001
70897865|NCT00514735|141283587|SUPERIORITY_OR_OTHER|||||||0.1427||||||An exact, one-sample binomial test was conducted at a one-sided α=0.025 level of significance.|Fisher Exact|||"H0: Pa ≥ 0.16 Ha: Pa \< 0.16~where Pa is the proportion of acute safety failures in the ablation management arm."||||0.1427
70897866|NCT00514735|141283588|NON_INFERIORITY_OR_EQUIVALENCE|This objective was not statistically powered. The non-inferiority chronic safety margin was 0.06.||||||0.0033|||||||t-test, 1 sided|||"H0: Pa ≥ Pm + 0.06 Ha: Pa \< Pm + 0.06~where Pa is the proportion of failed subjects in the ablation management arm and Pm is the proportion of failed subjects in the optimal medical management/drug therapy arm."||||0.0033
70897867|NCT00514735|141283590|SUPERIORITY_OR_OTHER|||||||0.35|||||||ANOVA|||"H0: μa = μm Ha: μa ≠ μm~where μa is the change of LAD from baseline to 6 month in Ablation Management arm, and μm is the change of LAD from baseline to 6 month in Medical Management arm."||||0.35
70897868|NCT00514735|141283591|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANOVA|||"H0: μa = μm Ha: μa ≠ μm~where μa is the change of LVEF from baseline to 6 month in Ablation Management arm, and μm is the change of LVEF from baseline to 6 month in Medical Management arm."||||0.06
70897869|NCT00514735|141283592|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
70897870|NCT00514735|141283593|SUPERIORITY_OR_OTHER||||||<|0.025|||||||Mixed Models Analysis|||||||<0.025
70897871|NCT04393441|141283594|NON_INFERIORITY|MMRM with fixed effects=treatment, visit, visit by treatment interaction,Baseline total staining stratum(TSS),and Baseline TSS by visit interaction.|Least Squares Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.57||0.0475|TWO_SIDED|95.0|0.01|2.27|||MMRM|||Change from Baseline in Total Staining Score at Day 90: The null hypothesis was that 011516X tear formulation was to be considered noninferior to Systane Ultra MD if the upper limit of 2-sided confidence interval (CI) was less than 2.3 units.||2.27|0.01|0.0475
70897872|NCT04393441|141283595|OTHER|No formal hypothesis was planned. The p-value for treatment differences is reported for reference.|Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|16.32||0.9001|TWO_SIDED|95.0|-30.03|34.14|||MMRM|MMRM with fixed effects=treatment, visit, visit by treatment interaction, Baseline TSS, and Baseline TSS by visit interaction.||||34.14|-30.03|0.9001
70897873|NCT00689221|141283596|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.021||||0.8623|TWO_SIDED|95.0|0.808|1.291||P-value is not adjusted for multiple testing.|Log Rank|||||1.291|0.808|0.8623
70897874|NCT01596582|141283616|SUPERIORITY|||||||0.4|||||||Chi-squared|||||||0.40
70897875|NCT01596582|141283617|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.51
70897876|NCT01596582|141283618|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70897877|NCT01596582|141283619|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70897878|NCT01596582|141283620|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
70897879|NCT01596582|141283621|SUPERIORITY||||||>|0.05||||||The p-value for each comparison was non-significanct.|Wilcoxon (Mann-Whitney)|||||||>0.05
70897880|NCT01596582|141283622|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.51
70897881|NCT01596582|141283623|SUPERIORITY|||||||0.62|||||||Fisher Exact|||||||0.62
70897882|NCT01596582|141283624|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
70897883|NCT01596582|141283625|SUPERIORITY|||||||0.39|||||||Fisher Exact|||||||0.39
70897884|NCT03923933|141283633|SUPERIORITY||||||<|0.001|||||||ANOVA|anova repeated measures||||||<0.001
70897885|NCT03923933|141283634|SUPERIORITY|||||||0.006|||||||ANOVA|Repeated Measures||||||0.006
70897886|NCT03923933|141283635|SUPERIORITY|||||||0.371|||||||ANOVA|||||||0.371
70897887|NCT03923933|141283636|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
70897888|NCT03923933|141283638|SUPERIORITY|||||||0.028|||||||ANOVA|||||||0.028
70897889|NCT03923933|141283639|SUPERIORITY|||||||0.018|||||||ANOVA|||||||0.018
70897890|NCT00419263|141283649|SUPERIORITY_OR_OTHER|||||||0.377|TWO_SIDED||||||Regression, Cox|P-value is based on the treatment parameter from the Cox Regression Model including treatment, current smoking behavior, and geographic region.||||||0.377
70897891|NCT00419263|141283650|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED|||||P-value is based on the log-rank statistic controlling for current smoking behavior and geographic region.|Log Rank|||||||0.007
70897892|NCT00419263|141283651|SUPERIORITY_OR_OTHER|||||||0.537|TWO_SIDED|||||P-value is based on the log-rank statistic controlling for current smoking behavior and geographic region.|Log Rank|||||||0.537
70897893|NCT00419263|141283652|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior.|Wilcoxon (Mann-Whitney)|||||||0.002
70897894|NCT00419263|141283653|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior.|Wilcoxon (Mann-Whitney)|||||||< 0.001
70897895|NCT00419263|141283654|SUPERIORITY_OR_OTHER|||||||0.409|TWO_SIDED|||||The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior.|Wilcoxon (Mann-Whitney)|||||||0.409
70897896|NCT00419263|141283655|SUPERIORITY_OR_OTHER|||||||0.327|TWO_SIDED|||||The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior.|Wilcoxon (Mann-Whitney)|||||||0.327
70897897|NCT01786967|141283668|SUPERIORITY|This was a pilot study to provide preliminary data to inform future sample size estimates for a larger more definitive trial|Risk Ratio (RR)|0.96||||1|TWO_SIDED|95.0|0.53|1.71|||Fisher Exact|||Null hypothesis was that there will be no difference in treatment benefit scale between the two groups||1.71|0.53|1.0
70897898|NCT01786967|141283669|SUPERIORITY||Risk Ratio (RR)|0.85||||1|TWO_SIDED|95.0|0.76|0.95|||Fisher Exact|||Null hypothesis was that there was no difference in the rate of moderate to severe adverse events.||.95|.76|1.0
70897899|NCT04557930|141283670|SUPERIORITY||Odds Ratio (OR)|0.96||||0.41|TWO_SIDED|95.0|0.88|1.06|||Mixed Models Analysis|||We tested the association between exposure to the intervention and the incidence of ACP billing in the pre- and post-intervention periods using a mixed effects logistic regression model, adjusting for time, patient and hospital covariates.||1.06|0.88|0.41
70897900|NCT04557930|141283670|SUPERIORITY|Sensitivity analysis of the association between the intervention and ACP billing, adjusted for time, patient characteristics, hospital characteristics, and the interaction between step of the trial and the intervention.|Odds Ratio (OR)|1.03||||0.74|TWO_SIDED|95.0|0.89|1.19|||Mixed Models Analysis|Overall effect allowing effect heterogeneity across steps \<0.001 Interaction effect \<0.001|Step 1 cohort|||1.19|0.89|0.74
70897901|NCT04557930|141283670|SUPERIORITY||Odds Ratio (OR)|1.15||||0.09|TWO_SIDED|95.0|0.98|1.36|||Mixed Models Analysis|||Sensitivity analysis of the association between the intervention and ACP billing, adjusted for time, patient characteristics, hospital characteristics, and the interaction between step of the trial and the intervention.|Step 2 cohort|1.36|0.98|0.09
70897902|NCT04557930|141283670|SUPERIORITY||Odds Ratio (OR)|1.13||||0.11|TWO_SIDED|95.0|0.97|1.33|||Mixed Models Analysis|||Sensitivity analysis of the association between the intervention and ACP billing, adjusted for time, patient characteristics, hospital characteristics, and the interaction between step of the trial and the intervention.|Step 3 cohort|1.33|0.97|0.11
70897903|NCT04557930|141283670|SUPERIORITY||Odds Ratio (OR)|0.66|||<|0.001|TWO_SIDED|95.0|0.57|0.76|||Mixed Models Analysis||Step 4 cohort|Sensitivity analysis of the association between the intervention and ACP billing, adjusted for time, patient characteristics, hospital characteristics, and the interaction between step of the trial and the intervention.||0.76|0.57|<0.001
70897904|NCT04557930|141283670|SUPERIORITY||Odds Ratio (OR)|0.95||||0.49|TWO_SIDED|95.0|0.89|1.19|||Mixed Models Analysis|||Sensitivity analysis of the association between the intervention and ACP billing, adjusted for time, patient characteristics, hospital characteristics, and the interaction between step of the trial and the intervention.|Step 5 cohort|1.19|0.89|0.49
70897905|NCT01563536|141283686|SUPERIORITY_OR_OTHER||Mean Difference (Maximal Decrease)|-1.5||||0.035|TWO_SIDED|95.0|-2.81|-0.13||Pre-specified 2-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with the baseline log10 HCV RNA values as a covariate and with an effect for treatment arm.||||-0.13|-2.81|0.035
70897906|NCT00538590|141283692|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||ANOVA|||Null hypothesis: post-operative intraocular pressure change in ologen group is equal to that in Mitomycin-C group.||||0.95
70897907|NCT00538590|141283694|SUPERIORITY_OR_OTHER|||||||1||95.0|||||ANOVA|||Null hypothesis: post-operative intraocular pressure change in ologen group is equal to that in Mitomycin-C group.||||1.00
70897908|NCT00538590|141283695|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||ANOVA|||Null hypothesis: post-operative intraocular pressure change in ologen group is equal to that in Mitomycin-C group.||||0.40
70897909|NCT00538590|141283696|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||ANOVA|||Null hypothesis: post-operative intraocular pressure change in ologen group is equal to that in Mitomycin-C group.||||0.91
70897910|NCT02460692|141283752|SUPERIORITY|||||||0.78||||||The average pain change at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect.|unstructured covariance model|||This is the primary comparison.||||0.78
70897911|NCT02460692|141283752|SUPERIORITY|||||||0.07||||||The average pain change at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect.|Unstructured covariance model|||This is the secondary comparison.||||0.070
70897912|NCT02460692|141283752|SUPERIORITY|||||||0.044||||||The average pain change at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect.|Unstructured covariance model|||This is an exploratory comparison||||0.044
70897913|NCT02460692|141283753|SUPERIORITY|||||||0.27||||||The average change of impact scores at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.27
70897914|NCT02460692|141283753|SUPERIORITY|||||||0.96||||||The average change of impact scores at the treatment period (weeks 5-8) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect.|unstructured covariance model|||||||0.96
70897915|NCT02460692|141283753|SUPERIORITY|||||||0.3||||||The average change of impact scores at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.30
70897916|NCT02460692|141283754|SUPERIORITY|||||||0.44||||||The average NPS change at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.44
70897917|NCT02460692|141283754|SUPERIORITY|||||||0.53||||||The average pain change at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect|Unstructured covariance model|||||||0.53
70897918|NCT02460692|141283754|SUPERIORITY|||||||0.18||||||The average NPS change at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect|Unstructured covariance model|||||||0.18
70897919|NCT02460692|141283755|SUPERIORITY|||||||0.95||||||The average change of learning scores at the treatment period (weeks 5-8) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.95
70897920|NCT02460692|141283755|SUPERIORITY|||||||0.94||||||The average change of learning scores at the treatment period (weeks 5-8) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.94
70897921|NCT02460692|141283755|SUPERIORITY|||||||0.9||||||The average change of learning score at the treatment period (weeks 5-8) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||.90
70897922|NCT02460692|141283756|SUPERIORITY|||||||0.93||||||The average change of total time completing task in grooved pegboard test on dominant hand (weeks 5-8 at the treatment period) from baseline were compared between the two arms using an unstructured covariance model|unstructured covariance model|||||||0.93
70897923|NCT02460692|141283756|SUPERIORITY|||||||0.92||||||The average change of total time completing task in grooved pegboard test on dominant hand (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model|unstructured covariance model|||||||0.92
70897924|NCT02460692|141283756|SUPERIORITY|||||||0.85||||||The average change of total time completing task in grooved pegboard test on dominant hand (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model|unstructured covariance model|||||||0.85
70897925|NCT02460692|141283757|SUPERIORITY|||||||0.89||||||The average change in Wechsler Adult Intelligence Scale (WAIS)-III test score (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model.|Unstructured covariance model|||||||0.89
70897926|NCT02460692|141283757|SUPERIORITY|||||||0.13||||||The average change in WAIS-III test score (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model|unstructured covariance model|||||||0.13
70897927|NCT02460692|141283757|SUPERIORITY|||||||0.14||||||The average change in WAIS-III test score (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model|unstructured covariance model|||||||0.14
70897928|NCT02460692|141283758|SUPERIORITY|||||||0.1||||||The average change of total mood disturbance scores (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect.|Unstructured covariance model|||||||0.10
70897929|NCT02460692|141283758|SUPERIORITY|||||||0.67||||||The average change of total mood disturbance scores (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect.|unstructured covariance model|||||||0.67
70897930|NCT02460692|141283758|SUPERIORITY|||||||0.25||||||The average change of total mood disturbance scores (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect.|unstructured covariance model|||||||0.25
70897931|NCT02460692|141283759|SUPERIORITY|||||||0.84||||||The average change of beck score (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.84
70897932|NCT02460692|141283759|SUPERIORITY|||||||0.91||||||The average change of beck score (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.91
70897933|NCT02460692|141283759|SUPERIORITY|||||||0.75||||||The average change of beck score (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.75
70897934|NCT02460692|141283760|SUPERIORITY|||||||0.24||||||Area under the time concentration curve (AUC) was calculated as the aggregate effect of response and compared between the arms.|Regression, Linear|||||||0.24
70897935|NCT02460692|141283760|SUPERIORITY|||||||0.08||||||Area under the time concentration curve (AUC) was calculated as the aggregate effect of response and compared between the arms.|Regression, Linear|||||||0.080
70897936|NCT02460692|141283760|SUPERIORITY|||||||0.005||||||Area under the time concentration curve (AUC) was calculated as the aggregate effect of response and compared between the arms.|Regression, Linear|||||||0.005
70897937|NCT02460692|141283761|SUPERIORITY|||||||0.6|||||||unstructured covariance model|||||||0.60
70897938|NCT02460692|141283761|SUPERIORITY|||||||0.4|||||||unstructured covariance model|||||||0.40
70897939|NCT02460692|141283761|SUPERIORITY|||||||0.72|||||||unstructured covariance model|||||||0.72
70897940|NCT02460692|141283762|SUPERIORITY|||||||0.19||||||The average change of pain sensitivity (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model.|unstructured covariance model|||||||0.19
70897941|NCT02460692|141283762|SUPERIORITY|||||||0.7||||||The average change of pain sensitivity (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model.|unstructured covariance model|||||||0.70
70897942|NCT02460692|141283762|SUPERIORITY|||||||0.36||||||The average change of pain sensitivity (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model|unstructured covariance model|||||||0.36
70897943|NCT02460692|141283763|SUPERIORITY|||||||0.14|||||||Regression, Linear|||Change in withdrawal intensity from week 8 to week 10 was compared between the two arms.||||.14
70897944|NCT02460692|141283763|SUPERIORITY|||||||0.6|||||||Regression, Linear|||Change in withdrawal intensity from week 8 to week 10 was compared between the two arms.||||.60
70897945|NCT02460692|141283763|SUPERIORITY|||||||0.34|||||||Regression, Linear|||Change in withdrawal intensity from week 8 to week 10 was compared between the two arms.||||.34
70897946|NCT02460692|141283764|SUPERIORITY|||||||0.34|||||||unstructured covariance model|||||||0.34
70897947|NCT02460692|141283764|SUPERIORITY|||||||0.007|||||||unstructured covariance model|||||||0.007
70897948|NCT02460692|141283764|SUPERIORITY|||||||0.055|||||||unstructured covariance model|||||||0.055
70897949|NCT02460692|141283765|SUPERIORITY|||||||0.69|||||||unstructured covariance model|||||||0.69
70897950|NCT02460692|141283765|SUPERIORITY|||||||0.79|||||||unstructured covariance model|||||||0.79
70897951|NCT02460692|141283765|SUPERIORITY|||||||0.97|||||||unstructured covariance model|||||||0.97
70897952|NCT02460692|141283766|SUPERIORITY|||||||0.21||||||Area under the time concentration curve (AUC) was calculated as the aggregate effect of response and compared between the arms.|Regression, Linear|||||||0.21
70897953|NCT02460692|141283766|SUPERIORITY|||||||0.029||||||Area under the time concentration curve (AUC) was calculated as the aggregate effect of response and compared between the arms.|Regression, Linear|||||||0.029
70897954|NCT02460692|141283766|SUPERIORITY|||||||0.001||||||Area under the time concentration curve (AUC) was calculated as the aggregate effect of response and compared between the arms.|Regression, Linear|||||||0.001
70897955|NCT02460692|141283767|SUPERIORITY|||||||0.084|||||||Regression, Linear|||Change in negative impact of withdrawal from week 8 to week 10 was compared between the two arms.||||0.084
70897956|NCT02460692|141283767|SUPERIORITY|||||||0.98|||||||Regression, Linear|||Change in negative impact of withdrawal from week 8 to week 10 was compared between the two arms.||||0.98
70897957|NCT02460692|141283767|SUPERIORITY|||||||0.085|||||||Regression, Linear|||Change in negative impact of withdrawal from week 8 to week 10 was compared between the two arms.||||0.085
70897958|NCT02460692|141283768|SUPERIORITY|||||||0.95||||||The average change of pain tolerance (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model|unstructured covariance model|||||||0.95
70897959|NCT02460692|141283768|SUPERIORITY|||||||0.78||||||The average change of pain tolerance (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model.|unstructured covariance model|||||||0.78
70897960|NCT02460692|141283768|SUPERIORITY|||||||0.99||||||The average change of pain tolerance (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model.|unstructured covariance model|||||||0.99
70897961|NCT00541450|141283789|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|For Least Squares Mean, the ANCOVA model included a term for treatment and the baseline value as a covariate.||||||0.002
70897962|NCT00541450|141283790|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|For Least Squares Mean, the ANCOVA model included a term for treatment and the baseline value as a covariate.||||||0.001
70897963|NCT00541450|141283791|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.16||||||95.0|-0.37|0.05|||ANCOVA|For Least Squares Mean, the ANCOVA model included a term for treatment and the baseline value as a covariate.||||0.05|-0.37|
70897964|NCT00541450|141283793|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANCOVA|For Least Squares Mean, the ANCOVA model included a term for treatment and the baseline value as a covariate.||||||0.030
70897965|NCT00803452|141283795|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||.001
70897966|NCT02816138|141283798|OTHER||||||<|0.001|||||||Regression, Linear|For change in depression severity (MADRS) over time, we used a linear mixed effects model with autoregressive of order 1 (AR(1)) temporal process.||||||<0.001
70897967|NCT02816138|141283799|OTHER|||||||0.761|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed-rank test||||||0.761
70897968|NCT02816138|141283800|OTHER|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed-rank test assessing for change from baseline to 12-weeks||||0.084
70897969|NCT02816138|141283801|OTHER|||||||0.073|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed-rank test assessing for change from baseline to 12-weeks||||0.073
70897970|NCT02816138|141283802|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed-rank test||||||0.002
70897971|NCT02816138|141283803|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||<0.001
70897972|NCT02816138|141283804|OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed-rank test||||||0.049
70897973|NCT02816138|141283805|OTHER|||||||0.502|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||0.502
70897974|NCT02816138|141283806|OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||0.049
70897975|NCT02816138|141283807|OTHER|||||||0.068|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||0.068
70897976|NCT00981084|141283808|SUPERIORITY_OR_OTHER||||||=|0.19||95.0|||||t-test, 2 sided|||We used a crossover design to exame whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the RVLT learning, yeilding a difference score. we conducted an independent samples t test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||= .19
70897977|NCT00981084|141283808|SUPERIORITY_OR_OTHER||||||=|0.0005||95.0|||||t-test, 2 sided|||We used a crossover design to exame whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the RVLT delay, yielding a difference score. we conducted an independent samples t test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||= .0005
70897978|NCT00981084|141283808|SUPERIORITY_OR_OTHER||||||=|0.21||95.0|||||t-test, 2 sided|||We used a crossover design to exame whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the BVMT learning, yeilding a difference score. we conducted an independent samples t test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||= .21
70897979|NCT00981084|141283808|SUPERIORITY_OR_OTHER||||||=|0.1||95.0|||||t-test, 2 sided|||We used a crossover design to exame whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the BVMT delay, yielding a difference score. we conducted an independent samples t test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||= .10
70897980|NCT00981084|141283809|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||t-test, 2 sided|||We used a crossover design to exame whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the CPT, yielding a difference score. we conducted an independent samples t test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||.33
70897981|NCT00981084|141283810|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||t-test, 2 sided|||We used a crossover design to examine whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the Stroop, yielding a difference score. We conducted an independent samples t-test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||.37
70897982|NCT00981084|141283811|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||t-test, 2 sided|||We used a crossover design to examine whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the Word Generation, yielding a difference score. We conducted an independent samples t-test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||.53
70897983|NCT00876915|141283812|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.695||||0.4795|TWO_SIDED|95.0|0.235|1.89|||stratified Cox|||||1.890|0.235|0.4795
70897984|NCT00876915|141283813|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|7.019||||0.0252|TWO_SIDED|95.0|1.236|131.632|||stratified Cox|||||131.632|1.236|0.0252
70897985|NCT04128293|141283838|OTHER||Ratio of Geometric Least Square Mean|0.877|||||TWO_SIDED|90.0|0.7585|1.0152|||||Relative bioavailability between treatment A and B assessed using analysis of variance with treatment, period, and sequence as fixed effects, participant as a random effect was performed on the natural log-transformed parameter of AUC(0-infinity).|||1.0152|0.7585|
70897986|NCT04128293|141283840|OTHER||Ratio of Geometric Least Square Mean|0.892|||||TWO_SIDED|90.0|0.7778|1.0239|||||Relative bioavailability between treatment A and B assessed using analysis of variance with treatment, period, and sequence as fixed effects, participant as a random effect was performed on the natural log-transformed parameter of AUC(0-t).|||1.0239|0.7778|
70897987|NCT04128293|141283842|OTHER||Ratio of Geometric Least Square Mean|0.946|||||TWO_SIDED|90.0|0.8594|1.0404|||||Relative bioavailability between treatment A and B assessed using analysis of variance with treatment, period, and sequence as fixed effects, participant as a random effect was performed on the natural log-transformed parameter of Cmax.|||1.0404|0.8594|
70897988|NCT04128293|141283845|OTHER||Median Difference (Final Values)|0.533||||0.4252|TWO_SIDED|90.0|-1.0|2.0||The p-value was assessed based on the Wilcoxon signed-rank test.|Wilcoxon signed-rank test||The median difference and the 90 percent (%) confidence interval of the median difference was estimated from Hodges-Lehmann estimate.|||2.0000|-1.0000|0.4252
70897989|NCT04128293|141283845|OTHER||Median Difference (Final Values)|1.0||||0.3125|TWO_SIDED|90.0|-0.75|5.25||The p-value was assessed based on the Wilcoxon rank sum test.|Wilcoxon rank sum test||The median difference and the 90% confidence interval of the median difference were estimated from Hodges-Lehmann estimate.|||5.2500|-0.7500|0.3125
70897990|NCT00437645|141283890|NON_INFERIORITY_OR_EQUIVALENCE|Statistical analysis for non-inferiority of valsartan/amlodipine 160/5 mg to amlodipine 10 mg alone with a non-inferiority margin of 3 mm Hg|Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|95.0|-3.0|-0.44|||ANCOVA|||||-0.44|-3.00|
70897991|NCT03382782|141283897|SUPERIORITY||Mean Difference (Net)|0.36||||0.025|TWO_SIDED||||||ANOVA|degrees of freedom = (3, 172)||||||.025
70897992|NCT03382782|141283898|SUPERIORITY||Mean Difference (Net)|0.243||||0.784|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intent-to-treat analyses||||0.784
70897993|NCT03382782|141283898|SUPERIORITY||Mean Difference (Net)|0.058||||0.81|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses||||0.810
70897994|NCT03382782|141283899|SUPERIORITY||Mean Difference (Net)|1.77||||0.174|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intent-to-treat analyses||||0.174
70897995|NCT03382782|141283899|SUPERIORITY||Mean Difference (Net)|1.15||||0.286|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses||||0.286
70897996|NCT03382782|141283900|SUPERIORITY||Mean Difference (Net)|1.36||||0.261|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intent-to-treat analyses||||0.261
70897997|NCT03382782|141283900|SUPERIORITY||Mean Difference (Net)|0.012||||0.912|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses||||0.912
70897998|NCT03382782|141283902|SUPERIORITY||Mean Difference (Net)|1.74||||0.11|TWO_SIDED||||||ANOVA|degrees of freedom = 3, 172||||||0.11
70897999|NCT03382782|141283903|SUPERIORITY||Mean Difference (Net)|1.18||||0.09|TWO_SIDED||||||ANOVA|degrees of freedom = 3, 156||Mean systolic blood pressure||||0.09
70898000|NCT03382782|141283903|SUPERIORITY||Mean Difference (Net)|0.63||||0.05|TWO_SIDED||||||ANOVA|degrees of freedom = 3, 156||Mean diastolic blood pressure||||0.05
70898001|NCT03382782|141283905|SUPERIORITY|Intention-to-treat analyses. General Health subscale.|Mean Difference (Net)|2.14||||0.121|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||||||0.121
70898002|NCT03382782|141283905|SUPERIORITY||Mean Difference (Net)|1.71||||0.193|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses. General Health subscale.||||0.193
70898003|NCT03382782|141283905|SUPERIORITY||Mean Difference (Net)|0.181||||0.835|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intention-to-treat analyses. Bodily Pain subscale.||||0.835
70898004|NCT03382782|141283905|SUPERIORITY||Mean Difference (Net)|0.43||||0.513|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses, Bodily Pain subscale.||||0.513
70898005|NCT03382782|141283905|SUPERIORITY||Mean Difference (Net)|2.37||||0.097|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intention-to-treat analyses, Physical Functioning subscale.||||0.097
70898006|NCT03382782|141283905|SUPERIORITY||Mean Difference (Net)|0.04||||0.184|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses, Physical Functioning subscale.||||0.184
70898007|NCT03382782|141283905|SUPERIORITY||Mean Difference (Net)|1.06||||0.347|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intention-to-treat analyses. Emotional Well-Being subscale.||||0.347
70898008|NCT03382782|141283905|SUPERIORITY||Mean Difference (Net)|0.361||||0.549|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses, Emotional Well-Being subscale.||||0.549
70898009|NCT03382782|141283906|SUPERIORITY||Mean Difference (Net)|0.157||||0.855|TWO_SIDED||||||ANOVA|Degrees of freedom = 2,182||Intention-to-treat analyses||||.855
70898010|NCT03382782|141283906|SUPERIORITY||Mean Difference (Net)|0.011||||0.915|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses||||0.915
70898011|NCT03382782|141283908|SUPERIORITY||Mean Difference (Net)|0.68||||0.508|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intent-to-treat analyses||||0.508
70898012|NCT03382782|141283908|SUPERIORITY||Mean Difference (Net)|1.67||||0.198|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses||||0.198
70898013|NCT01316510|141283910|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||Primary outcome (percentage of bifidobacteria in the final stool specimen)||||<0.01
70898014|NCT01316510|141283911|SUPERIORITY_OR_OTHER|||||||0.44|||||||t-test, 2 sided|||Secondary outcome (length of hospital stay) for all 24 infants (this included two infants with intestinal atresia, both in the placebo group)||||0.44
70898015|NCT01490502|141283912|SUPERIORITY|||||||0.6|||||||Log Rank|||||||0.60
70898016|NCT01490502|141283912|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.57|TWO_SIDED|95.0|0.67|2.05|||Regression, Cox|||||2.05|0.67|0.57
70898017|NCT01490502|141283913|OTHER|||||||0.07|||||||Andersen Gill model for recurrent events|||||||0.07
70898018|NCT01490502|141283914|SUPERIORITY||Rate Ratio|1.8||||0.07|TWO_SIDED|95.0|0.94|3.45|||Negative Binomial Model|||||3.45|0.94|0.07
70898019|NCT01490502|141283915|SUPERIORITY||Rate Ratio|1.47||||0.14|TWO_SIDED|95.0|0.88|2.46|||Negative Binomial Model|||||2.46|0.88|0.14
70898020|NCT01490502|141283916|SUPERIORITY|||||||0.6|||||||Log Rank|||||||0.60
70898021|NCT01490502|141283917|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||The average rate of change in MSFC Z-score over time was analyzed using a linear mixed-effects model with unstructured covariance structure and random intercepts. The p-value is a test of whether there is a difference in the rate of change in the MSFC Z-score between treatment arms.||||0.20
70898022|NCT01490502|141283918|SUPERIORITY|||||||0.67|||||||Mixed Models Analysis|||Rate of change in 2.5% low-contrast acuity was analyzed using a linear mixed effects model with unstructured covariance structure and random intercepts. The p-value is a test of whether there is a difference in the rate of change in low-contrast acuity between treatment arms.||||0.67
70898023|NCT01490502|141283919|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||Rate of change in quality of life was analyzed using a linear mixed effects model with unstructured covariance structure and random intercepts. The p-value is a test of whether there is a difference in the rate of change in health-related quality of life between treatment arms.||||0.21
70898024|NCT01490502|141283920|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||||||0.13
70898025|NCT01490502|141283921|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||0.08
70898026|NCT04186780|141283933|SUPERIORITY|"The differences between Shiitake and placebo groups were analyzed by the Chi-square test, Exact of Fisher test and Student's t-test.~Descriptions of all biochemical parameters were expressed as mean ± standard deviation. To investigate the differences in biochemical parameters between the groups, Analysis of Variance (ANOVA) with repeated measurements was applied. All results of biochemical parameters were normalized to logarithmic scale."|Mean Difference (Net)|2.5||||0.59|TWO_SIDED|95.0||||P \< 0.05 was accepted as statistically significant.|ANOVA||Difference between T0 and T66 in the placebo group and intervention group in total cholesterol.|||||0.59
70898027|NCT04186780|141283934|SUPERIORITY|"The differences between Shiitake and placebo groups were analyzed by the Chi-square test, Exact of Fisher test and Student's t-test.~Descriptions of all biochemical and oxidative stress parameters were expressed as mean ± standard deviation. To investigate the differences in biochemical parameters between the groups, Analysis of Variance (ANOVA) with repeated measurements was applied. All results of biochemical parameters and oxidative stress were normalized to logarithmic scale."|Mean Difference (Net)|0.4||||0.8284|TWO_SIDED|95.0||||P \< 0.05 was accepted as statistically significant.|ANOVA||Difference between T0 and T66 in the placebo group and intervention group.|||||0.8284
70898028|NCT04186780|141283935|SUPERIORITY||Median Difference (Net)|0.1||||0.0058|TWO_SIDED|95.0||||P \< 0.05 was accepted as statistically significant.|ANOVA||Difference between T0 and T66 in the placebo group compared to the intervention group.|||||0.0058
70898029|NCT04186780|141283936|SUPERIORITY||Median Difference (Net)|0.8||||0.0384|TWO_SIDED|95.0||||P \< 0.05 was accepted as statistically significant.|ANOVA||Reduced difference in TBARS in the placebo group compared to the intervention group at T66.|||||0.0384
70898030|NCT04186780|141283937|SUPERIORITY|"The differences between Shiitake and placebo groups were analyzed by the Chi-square test, Exact of Fisher test and Student's t-test.~Descriptions of all biochemical and oxidative stress parameters were expressed as mean ± standard deviation. To investigate the differences in biochemical parameters between the groups, Analysis of Variance (ANOVA) with repeated measurements was applied. All results of biochemical parameters and oxidative stress were normalized to logarithmic scale."|Mean Difference (Net)|47.0||||0.0352|TWO_SIDED|95.0||||P \< 0.05 was accepted as statistically significant.|ANOVA||Difference between placebo group and intervention group of T66.|||||0.0352
70898031|NCT00772590|141283948|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||ANOVA|||||||<0.01
70898032|NCT01197508|141283997|SUPERIORITY_OR_OTHER||LS mean|1.1|STANDARD_ERROR_OF_MEAN|0.84||1|TWO_SIDED|95.0|-0.53|2.79||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.79|-0.53|1.000
70898033|NCT01197508|141283997|SUPERIORITY_OR_OTHER||LS mean|0.5|STANDARD_ERROR_OF_MEAN|0.85||1|TWO_SIDED|95.0|-1.22|2.13|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.13|-1.22|1.000
70898034|NCT01197508|141283997|SUPERIORITY_OR_OTHER||LS mean|0.5|STANDARD_ERROR_OF_MEAN|0.88||1|TWO_SIDED|95.0|-1.21|2.22|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.22|-1.21|1.000
70898035|NCT01197508|141283998|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71|STANDARD_ERROR_OF_MEAN|0.17||0.144|TWO_SIDED|95.0|0.45|1.12|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.12|0.45|0.144
70898036|NCT01197508|141283998|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74|STANDARD_ERROR_OF_MEAN|0.17||0.203|TWO_SIDED|95.0|0.47|1.17|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.17|0.47|0.203
70898037|NCT01197508|141283998|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52|STANDARD_ERROR_OF_MEAN|0.12||0.005|TWO_SIDED|95.0|0.32|0.82|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||0.82|0.32|0.005
70898038|NCT01197508|141283999|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89|STANDARD_ERROR_OF_MEAN|0.22||0.636|TWO_SIDED|95.0|0.54|1.45|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.45|0.54|0.636
70898039|NCT01197508|141283999|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73|STANDARD_ERROR_OF_MEAN|0.19||0.215|TWO_SIDED|95.0|0.44|1.2|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.20|0.44|0.215
70898040|NCT01197508|141283999|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58|STANDARD_ERROR_OF_MEAN|0.15||0.034|TWO_SIDED|95.0|0.35|0.96|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||0.96|0.35|0.034
70898041|NCT01197508|141284000|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85|STANDARD_ERROR_OF_MEAN|0.37||0.711|TWO_SIDED|95.0|0.36|1.99|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.99|0.36|0.711
70898042|NCT01197508|141284000|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79|STANDARD_ERROR_OF_MEAN|0.34||0.594|TWO_SIDED|95.0|0.34|1.85|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.85|0.34|0.594
70898043|NCT01197508|141284000|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15|STANDARD_ERROR_OF_MEAN|0.49||0.749|TWO_SIDED|95.0|0.5|2.65|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.65|0.50|0.749
70898044|NCT01197508|141284001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52|STANDARD_ERROR_OF_MEAN|0.16||0.037|TWO_SIDED|95.0|0.28|0.96|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||0.96|0.28|0.037
70898045|NCT01197508|141284001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69|STANDARD_ERROR_OF_MEAN|0.21||0.222|TWO_SIDED|95.0|0.38|1.25|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.25|0.38|0.222
70898046|NCT01197508|141284001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52|STANDARD_ERROR_OF_MEAN|0.17||0.042|TWO_SIDED|95.0|0.28|0.98|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||0.98|0.28|0.042
70898047|NCT01197508|141284002|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04|STANDARD_ERROR_OF_MEAN|0.41||0.913|TWO_SIDED|95.0|0.48|2.27|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.27|0.48|0.913
70898048|NCT01197508|141284002|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92|STANDARD_ERROR_OF_MEAN|0.37||0.841|TWO_SIDED|95.0|0.42|2.01|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.01|0.42|0.841
70898049|NCT01197508|141284002|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61|STANDARD_ERROR_OF_MEAN|0.26||0.239|TWO_SIDED|95.0|0.26|1.39|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.39|0.26|0.239
70898050|NCT01197508|141284003|SUPERIORITY_OR_OTHER||LS mean|1.1|STANDARD_ERROR_OF_MEAN|0.705||0.12|TWO_SIDED|95.0|-0.288|2.481|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||2.481|-0.288|0.120
70898051|NCT01197508|141284003|SUPERIORITY_OR_OTHER||LS mean|0.95|STANDARD_ERROR_OF_MEAN|0.715||0.184|TWO_SIDED|95.0|-0.452|2.354|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||2.354|-0.452|0.184
70898052|NCT01197508|141284003|SUPERIORITY_OR_OTHER||LS mean|2.09|STANDARD_ERROR_OF_MEAN|0.711||0.003|TWO_SIDED|95.0|0.692|3.484|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||3.484|0.692|0.003
70898053|NCT01197508|141284004|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.12||0.131||95.0|-0.05|0.42|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.42|-0.05|0.131
70898054|NCT01197508|141284004|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.551|TWO_SIDED|95.0|-0.17|0.31|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.31|-0.17|0.551
70898055|NCT01197508|141284004|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.645|TWO_SIDED|95.0|-0.19|0.3|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.30|-0.19|0.645
70898056|NCT01197508|141284005|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62|STANDARD_ERROR_OF_MEAN|0.15||0.046|TWO_SIDED|95.0|0.38|0.99|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||0.99|0.38|0.046
70898057|NCT01197508|141284005|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62|STANDARD_ERROR_OF_MEAN|0.15||0.051|TWO_SIDED|95.0|0.38|1.0|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||1.00|0.38|0.051
70898058|NCT01197508|141284005|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6|STANDARD_ERROR_OF_MEAN|0.15||0.04|TWO_SIDED|95.0|0.37|0.98|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||0.98|0.37|0.040
70898059|NCT01197508|141284006|SUPERIORITY_OR_OTHER||LS mean|0.7|STANDARD_ERROR_OF_MEAN|0.66||0.273|TWO_SIDED|95.0|-0.58|2.03|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.||2.03|-0.58|0.273
70898060|NCT01197508|141284006|SUPERIORITY_OR_OTHER||LS mean|0.7|STANDARD_ERROR_OF_MEAN|0.67||0.315|TWO_SIDED|95.0|-0.65|2.0|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.||2.00|-0.65|0.315
70898061|NCT01197508|141284006|SUPERIORITY_OR_OTHER||LS mean|1.2|STANDARD_ERROR_OF_MEAN|0.67||0.078|TWO_SIDED|95.0|-0.13|2.51|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.||2.51|-0.13|0.078
70898062|NCT01197508|141284007|SUPERIORITY_OR_OTHER||LS mean|0.3|STANDARD_ERROR_OF_MEAN|0.47||0.59|TWO_SIDED|95.0|-0.68|1.19|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.19|-0.68|0.590
70898063|NCT01197508|141284007|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.48||0.679|TWO_SIDED|95.0|-0.74|1.14|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.14|-0.74|0.679
70898064|NCT01197508|141284007|SUPERIORITY_OR_OTHER||LS mean|0.6|STANDARD_ERROR_OF_MEAN|0.48||0.215|TWO_SIDED|95.0|-0.35|1.53|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.53|-0.35|0.215
70898065|NCT01197508|141284008|SUPERIORITY_OR_OTHER||LS mean|1.2|STANDARD_ERROR_OF_MEAN|0.61||0.052|TWO_SIDED|95.0|-0.01|2.38|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.38|-0.01|0.052
70898066|NCT01197508|141284008|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.61||0.874|TWO_SIDED|95.0|-1.11|1.3|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.30|-1.11|0.874
70898067|NCT01197508|141284008|SUPERIORITY_OR_OTHER||LS mean|1.0|STANDARD_ERROR_OF_MEAN|0.62||0.099|TWO_SIDED|95.0|-0.19|2.24|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.24|-0.19|0.099
70898068|NCT01197508|141284009|SUPERIORITY_OR_OTHER||LS mean|0.6|STANDARD_ERROR_OF_MEAN|0.69||0.394|TWO_SIDED|95.0|-0.77|1.95|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.95|-0.77|0.394
70898069|NCT01197508|141284009|SUPERIORITY_OR_OTHER||LS mean|0.3|STANDARD_ERROR_OF_MEAN|0.7||0.712|TWO_SIDED|95.0|-1.11|1.63|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.63|-1.11|0.712
70898070|NCT01197508|141284009|SUPERIORITY_OR_OTHER||LS mean|1.0|STANDARD_ERROR_OF_MEAN|0.71||0.167|TWO_SIDED|95.0|-0.41|2.38|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.38|-0.41|0.167
70898071|NCT01197508|141284010|SUPERIORITY_OR_OTHER||LS mean|1.5|STANDARD_ERROR_OF_MEAN|0.75||0.046|TWO_SIDED|95.0|0.02|2.95|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects the model; pooled center is a random effect.||2.95|0.02|0.046
70898072|NCT01197508|141284010|SUPERIORITY_OR_OTHER||LS mean|0.3|STANDARD_ERROR_OF_MEAN|0.75||0.681|TWO_SIDED|95.0|-1.17|1.79|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.79|-1.17|0.681
70898073|NCT01197508|141284010|SUPERIORITY_OR_OTHER||LS mean|1.3|STANDARD_ERROR_OF_MEAN|0.77||0.087|TWO_SIDED|95.0|-0.19|2.84|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.84|-0.19|0.087
70898074|NCT01197508|141284011|SUPERIORITY_OR_OTHER||LS mean|0.98|STANDARD_ERROR_OF_MEAN|0.736||1|TWO_SIDED|95.0|-0.464|2.427||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.427|-0.464|1.000
70898075|NCT01197508|141284011|SUPERIORITY_OR_OTHER||LS mean|0.72|STANDARD_ERROR_OF_MEAN|0.746||1|TWO_SIDED|95.0|-0.74|2.188||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.188|-0.740|1.000
70898076|NCT01197508|141284011|SUPERIORITY_OR_OTHER||LS mean|0.85|STANDARD_ERROR_OF_MEAN|0.762||1|TWO_SIDED|95.0|-0.649|2.346||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.346|-0.649|1.000
70898077|NCT01197508|141284012|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.29||0.914|TWO_SIDED|95.0|-0.54|0.61|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.61|-0.54|0.914
70898078|NCT01197508|141284012|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.446|TWO_SIDED|95.0|-0.36|0.81|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.81|-0.36|0.446
70898079|NCT01197508|141284012|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.31||0.656|TWO_SIDED|95.0|-0.47|0.75|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.75|-0.47|0.656
70898080|NCT01197508|141284013|SUPERIORITY_OR_OTHER||LS mean|0.3|STANDARD_ERROR_OF_MEAN|0.26||0.248|TWO_SIDED|95.0|-0.21|0.82|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.82|-0.21|0.248
70898081|NCT01197508|141284013|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.27||0.498|TWO_SIDED|95.0|-0.34|0.7|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.70|-0.34|0.498
70898082|NCT01197508|141284013|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.27||0.441|TWO_SIDED|95.0|-0.32|0.74|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.74|-0.32|0.441
70898083|NCT01197508|141284014|SUPERIORITY_OR_OTHER||LS mean|0.4|STANDARD_ERROR_OF_MEAN|0.26||0.174|TWO_SIDED|95.0|-0.16|0.87|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.87|-0.16|0.174
70898084|NCT01197508|141284014|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.27||0.402|TWO_SIDED|95.0|-0.3|0.74|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.74|-0.30|0.402
70898085|NCT01197508|141284014|SUPERIORITY_OR_OTHER||LS mean|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.197|TWO_SIDED|95.0|-0.18|0.88|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.88|-0.18|0.197
70898086|NCT01197508|141284015|SUPERIORITY_OR_OTHER||LS mean|-1.47|STANDARD_ERROR_OF_MEAN|1.643||0.371|TWO_SIDED|95.0|-4.697|1.756|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.756|-4.697|0.371
70898087|NCT01197508|141284015|SUPERIORITY_OR_OTHER||LS mean|-1.32|STANDARD_ERROR_OF_MEAN|1.672||0.432|TWO_SIDED|95.0|-4.597|1.967|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.967|-4.597|0.432
70898088|NCT01197508|141284015|SUPERIORITY_OR_OTHER||LS mean|-2.71|STANDARD_ERROR_OF_MEAN|1.672||0.105|TWO_SIDED|95.0|-5.992|0.573|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.573|-5.992|0.105
70898089|NCT01197508|141284016|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.312|TWO_SIDED|95.0|-0.29|0.09|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.09|-0.29|0.312
70898090|NCT01197508|141284016|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.885|TWO_SIDED|95.0|-0.18|0.21|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.21|-0.18|0.885
70898091|NCT01197508|141284016|SUPERIORITY_OR_OTHER||LS mean|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.067|TWO_SIDED|95.0|-0.37|0.01|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.01|-0.37|0.067
70898092|NCT01197508|141284017|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.152|TWO_SIDED|95.0|-0.33|0.05|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.05|-0.33|0.152
70898093|NCT01197508|141284017|SUPERIORITY_OR_OTHER||LS mean|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.078|TWO_SIDED|95.0|-0.37|0.02|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.02|-0.37|0.078
70898094|NCT01197508|141284017|SUPERIORITY_OR_OTHER||LS mean|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.033|TWO_SIDED|95.0|-0.41|-0.02|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||-0.02|-0.41|0.033
70898095|NCT01197508|141284018|SUPERIORITY_OR_OTHER||LS mean|-0.011|STANDARD_ERROR_OF_MEAN|0.0181||0.543|TWO_SIDED|95.0|-0.0465|0.0245||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0245|-0.0465|0.543
70898096|NCT01197508|141284018|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.0183||0.998|TWO_SIDED|95.0|-0.036|0.0361||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0361|-0.0360|0.998
70898097|NCT01197508|141284018|SUPERIORITY_OR_OTHER||LS mean|-0.006|STANDARD_ERROR_OF_MEAN|0.0188||0.743|TWO_SIDED|95.0|-0.0432|0.0308||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0308|-0.0432|0.743
70898098|NCT01197508|141284018|SUPERIORITY_OR_OTHER||LS mean|-2.3|STANDARD_ERROR_OF_MEAN|1.95||0.244|TWO_SIDED|95.0|-6.1|1.56||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.56|-6.10|0.244
70898099|NCT01197508|141284018|SUPERIORITY_OR_OTHER||LS mean|-1.7|STANDARD_ERROR_OF_MEAN|1.98||0.389|TWO_SIDED|95.0|-5.59|2.18||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.18|-5.59|0.389
70898100|NCT01197508|141284018|SUPERIORITY_OR_OTHER||LS mean|-2.8|STANDARD_ERROR_OF_MEAN|2.02||0.165|TWO_SIDED|95.0|-6.79|1.16||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.16|-6.79|0.165
70898101|NCT01301391|141284019|SUPERIORITY||Single proportion|0.54|||<|0.001|TWO_SIDED|95.0|0.33|0.74||A priori threshold for statistical significance = 0.05|Fisher Exact|||H0:p≤ 25% vs H1:p\> 25% with an interesting PFS-3 rate of 50% (median PFS of 3 months), alpha=0.05 and beta=0.10, 30 evaluable patients are required for a single stage trial. If at the end of the trial 12 or more out of 30 evaluable patients are alive and progression-free at 3 months since the treatment start date, the null hypothesis are rejected. A Fleming multiple-testing procedure is applied. If \>=4 successes out of the first 15 patients are observed, accrual will continue up to 30.||0.74|0.33|<0.001
70898102|NCT02629991|141284026|SUPERIORITY|||||||0.059||||||Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.|Mixed effects model|||||||0.059
70898103|NCT02629991|141284027|SUPERIORITY|||||||0.088||||||Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.|Mixed effects model|||||||0.088
70898104|NCT02629991|141284028|SUPERIORITY|||||||0.027|||||||Mixed effects model|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.027
70898105|NCT02629991|141284029|SUPERIORITY|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.16|||||||Mixed effects model|||||||0.16
70898106|NCT02629991|141284030|SUPERIORITY|||||||0.69|||||||Mixed effects model|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.69
70898107|NCT02629991|141284031|SUPERIORITY|||||||0.034||||||Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.|Mixed effects model|||||||0.034
70898108|NCT02629991|141284032|SUPERIORITY|||||||0.009|||||||Mixed effects model|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.009
70898109|NCT02629991|141284033|SUPERIORITY|||||||0.033|||||||Mixed effects model|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.033
70898110|NCT02629991|141284034|SUPERIORITY|||||||0.78|||||||Mixed effects model|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.78
70898111|NCT02629991|141284035|SUPERIORITY|||||||0.53|||||||Mixed effects model|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.53
70898112|NCT02799784|141284036|NON_INFERIORITY|If the lower bound of the two-sided 95% confidence interval around the (UMEC/VI 62.5/25 mcg versus TIO/OLO 5/5 mcg) treatment difference is above -50 milliliter then UMEC/VI 62.5/25 mcg was to be considered non-inferior to TIO/OLO 5/5 mcg.|Mean Difference (Final Values)|0.053|||<|0.001|TWO_SIDED|95.0|0.026|0.08|||Mixed Models Analysis|||||0.080|0.026|<0.001
70898113|NCT01624948|141284037|SUPERIORITY_OR_OTHER|||||||0.53|||||||Fisher Exact|||||||0.53
70898114|NCT01624948|141284039|SUPERIORITY_OR_OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Difference in p70S6 kinase phosphorylation as measured by mean fluorescence intensity (MFI) between those patients who reached the primary endpoint and those who did not||||0.67
70898115|NCT01624948|141284040|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
70898116|NCT01624948|141284042|SUPERIORITY_OR_OTHER|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||||||0.49
70898117|NCT02570126|141284044|NON_INFERIORITY|Criterion for the Varilrix HSA-free vaccine as compared to Varilrix™ vaccine, the upper limit (UL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (VAR\_HSA\_F minus VAR) in incidence of fever \> 39.0°C (\> 102.2°F) within 0-14 days after Dose 1 was to be equal to or below 5%|Difference in percentage between groups|-1.29|||||TWO_SIDED|95.0|-3.72|1.08|||||Power obtained using PASS 2005 (Likelihood Score \[Miettinen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=2.5%|Non-inferiority of Varilrix HSA-free vaccine to Varilrix™ vaccine in terms of percentage of subjects reporting fever \> 39.0°C (\> 102.2°F) within 15-days (Days 0-14) after Dose 1 (VAR\_HSA\_F Group minus VAR Group)||1.08|-3.72|
70898118|NCT00917579|141284054|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCinf and Cmax fell within (80%, 125%).|ratio of adjusted geometric means|95.34||||||90.0|91.33|99.52|||ANOVA|Values were back-transformed from the log scale.|Parameter estimate = ratio (%) (test/reference) of adjusted geometric means. AUClast + (Clast\*/kel), where Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.|Natural log transformed AUCinf was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Adjusted mean difference (Test-Ref) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL \<=µT - µR \<=θU); null hypothesis of inequivalence: (Ho: µT - µR \<θL or µT - µR \>θU).||99.52|91.33|
70898119|NCT00917579|141284055|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both the AUCinf and Cmax fell within (80%, 125%). AUCinf method of determination includes AUC last calculated value.|ratio of adjusted geometric means|95.79||||||90.0|91.07|100.76|||ANOVA|Values have been back-transformed from the log scale.|Parameter estimate = ratio (%) (test/reference) of adjusted geometric means. Log-linear trapezoidal method.|Natural log transformed AUClast was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence interval was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean (Test/Reference) and 90% confidence interval for the ratio.||100.76|91.07|
70898120|NCT00917579|141284056|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCinf and Cmax fell within (80%, 125%).|ratio of adjusted geometric means|91.41||||||90.0|83.39|100.2|||ANOVA|Values have been back-transformed from the log scale.|Parameter estimate = ratio (%) (test/reference) of adjusted geometric means.|Natural log transformed Cmax was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals were obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean (Test/Reference) and 90% confidence interval for the ratio.||100.20|83.39|
70898121|NCT04683926|141284065|OTHER||AUC(0-36) Estimate (β1)|1.0227|||||TWO_SIDED|||||||||Analysis of dose proportionality following 10, 20 and 30 mg fasted using a mixed-effects model based on a power function: ln(dependent variable) = β1×ln(Dose) + ln(β0) + ε. Random slope and intercept. 90% CI of β1 acceptance range of 0.8-1.25 modified to account for ratio of dose levels in this study as follows: \[1+ln(0.8)/ln(3), 1+ln(1.25)/ln(3)\], giving acceptance range of \[0.7969, 1.2031\]. If the 90% CI of β1 is within \[0.7969, 1.2031\], dose-proportionality is proven for the PK parameter.||||
70898122|NCT04683926|141284065|OTHER||AUC(inf) Estimate (β1)|1.0223|||||TWO_SIDED|||||||||Analysis of dose proportionality following 10, 20 and 30 mg fasted using a mixed-effects model based on a power function: ln(dependent variable) = β1×ln(Dose) + ln(β0) + ε. Random slope and intercept. 90% CI of β1 acceptance range of 0.8-1.25 modified to account for ratio of dose levels in this study as follows: \[1+ln(0.8)/ln(3), 1+ln(1.25)/ln(3)\], giving acceptance range of \[0.7969, 1.2031\]. If the 90% CI of β1 is within \[0.7969, 1.2031\], dose-proportionality is proven for the PK parameter.||||
70898123|NCT04683926|141284065|EQUIVALENCE|Absent food effect will be established if the 90% CI for the ratio of population geometric means between fed and fasted 30 mg doses, based on log-transformed data, is contained in the equivalence limits of 0.80-1.25 for AUC0-inf and Cmax.|AUC(0-inf) fed/fasted ratio|1.09|||||TWO_SIDED|90.0|1.05|1.12||||||Analysis of food effect on desmetramadol in the evaluable population using natural logarithm-transformed PK exposure parameters of desmetramadol enantiomers following administration of 30 mg desmetramadol in the fed and fasted states.||1.12|1.05|
70898124|NCT04683926|141284066|OTHER||Cmax Estimate (β1)|0.9899|||||TWO_SIDED|||||||||Analysis of dose proportionality following 10, 20 and 30 mg fasted using a mixed-effects model based on a power function: ln(dependent variable) = β1×ln(Dose) + ln(β0) + ε. Random slope and intercept. 90% CI of β1 acceptance range of 0.8-1.25 modified to account for ratio of dose levels in this study as follows: \[1+ln(0.8)/ln(3), 1+ln(1.25)/ln(3)\], giving acceptance range of \[0.7969, 1.2031\]. If the 90% CI of β1 is within \[0.7969, 1.2031\], dose-proportionality is proven for the PK parameter.||||
70898125|NCT04683926|141284066|EQUIVALENCE|Absent food effect will be established if the 90% CI for the ratio of population geometric means between fed and fasted 30 mg doses, based on log-transformed data, is contained in the equivalence limits of 0.80-1.25 for AUC0-inf and Cmax.|Cmax 90% fed/fasted ratio|1.18|||||TWO_SIDED|90.0|1.08|1.28||||||Analysis of food effect on desmetramadol in the evaluable population using natural logarithm-transformed PK exposure parameters of desmetramadol enantiomers following administration of 30 mg desmetramadol in the fed and fasted states.||1.28|1.08|
70898126|NCT02740049|141284077|SUPERIORITY|||||||0.0002||||||P value is the comparison between the IFN/TNF induction group versus the VR588 (10-7M) treatment group.|Wilcoxon (Mann-Whitney)|||Statistical differences is determined using the Kruskal-Wallis test followed by Dunn's multiple comparison test or a Wilcoxon signed rank test as appropriate.||||0.0002
70898127|NCT02740049|141284078|SUPERIORITY|||||||0.3994||||||P value is the comparison between the IFN/TNF induction group versus the VR588 (10-7M) treatment group|Wilcoxon (Mann-Whitney)|||Statistical differences is determined using the Kruskal-Wallis test followed by Dunn's multiple comparison test or Wilcoxon signed rank test as appropriate.||||0.3994
70898128|NCT02740049|141284079|SUPERIORITY|||||||0.0104||||||P value is the comparison between the IFN/TNF induction group versus VR588 (10-7M) treatment group.|Wilcoxon (Mann-Whitney)|||Statistical difference is determined using the Kruskal-Wallis test followed by Dunn's multiple comparison test or a Wilcoxon signed rank test as appropriate.||||0.0104
70898129|NCT00952367|141284101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.641|||<|0.001|TWO_SIDED|95.0|1.247|2.159|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=12.514||Age of mother bearing, \<=30 years vs \>30 years||2.159|1.247|<0.001
70898130|NCT00952367|141284101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.793||||0.06|TWO_SIDED|95.0|0.622|1.01|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=3.529||Household register, local vs nonlocal||1.010|0.622|0.060
70898131|NCT00952367|141284101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.369||||0.006|TWO_SIDED|95.0|1.672|32.479|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=7.524||Mother's education level, illiteracy vs postgraduate or above||32.479|1.672|0.006
70898132|NCT00952367|141284101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.443||||0.102|TWO_SIDED|95.0|1.001|11.843|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=2.671||Mother's education level, elementary school vs postgraduate or above||11.843|1.001|0.102
70898133|NCT00952367|141284101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.064||||0.159|TWO_SIDED|95.0|0.933|10.067|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=1.984||Mother's education level, junior middle school vs postgraduate or above||10.067|0.933|0.159
70898134|NCT00952367|141284101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.321||||0.662|TWO_SIDED|95.0|0.71|7.589|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.191||Mother's education level, senior high school/vocational high school/technical secondary school vs postgraduate or above||7.589|0.710|0.662
70898135|NCT00952367|141284101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.306|||<|0.001|TWO_SIDED|95.0|0.399|4.277|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=13.525||Mother's education level, college/university vs postgraduate or above||4.277|0.399|<0.001
70898136|NCT00952367|141284101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.217||||0.043|TWO_SIDED|95.0|0.719|6.831|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=4.095||Family monthly income per capita, \<=600 RMB vs \>=10000 RMB||6.831|0.719|0.043
70898137|NCT00952367|141284101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.089||||0.01|TWO_SIDED|95.0|0.739|5.906|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=6.549||Family monthly income per capita, 600 to 1999 RMB vs \>=10000 RMB||5.906|0.739|0.010
70898138|NCT00952367|141284101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.983||||0.021|TWO_SIDED|95.0|0.704|5.583|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=5.313||Family monthly income per capita, 2000 to 4999 RMB vs \>=10000 RMB||5.583|0.704|0.021
70898139|NCT00952367|141284101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.364|TWO_SIDED|95.0|0.344|3.267|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.824||Family monthly income per capita, 5000 to 7999 RMB vs \>=10000 RMB||3.267|0.344|0.364
70898140|NCT00952367|141284101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58||||0.175|TWO_SIDED|95.0|0.1|3.347|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=1.838||||3.347|0.100|0.175
70898141|NCT00952367|141284101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.516|||<|0.001|TWO_SIDED|95.0|0.4|0.666|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=25.960||Whether have brothers or sisters, no vs yes||0.666|0.400|<0.001
70898142|NCT00952367|141284102|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.255||||0.057|TWO_SIDED|95.0|0.062|1.044|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=3.610||Birth information, preterm birth vs full-term birth||1.044|0.062|0.057
70898143|NCT00952367|141284102|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.666||||0.04|TWO_SIDED|95.0|0.451|0.981|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=4.228||Household register, local vs nonlocal||0.981|0.451|0.040
70898144|NCT00952367|141284102|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.182||||0.044|TWO_SIDED|95.0|0.758|1.844|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=4.074||Feeding manners within 6 months, pure breast feeding vs pure formula milk feeding||1.844|0.758|0.044
70898145|NCT00952367|141284102|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.707||||0.038|TWO_SIDED|95.0|0.42|1.191|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=4.316||Feeding manners within 6 months, mixed feeding vs pure formula milk feeding||1.191|0.420|0.038
70898146|NCT00952367|141284102|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|92.229||||0.006|TWO_SIDED|95.0|3.993|2130.5|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=7.438||Father's education level, illiteracy vs postgraduate or above||2130.500|3.993|0.006
70898147|NCT00952367|141284102|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.671||||0.778|TWO_SIDED|95.0|0.537|40.608|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.079||Father's education level, elementary school vs postgraduate or above||40.608|0.537|0.778
70898148|NCT00952367|141284102|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.83||||0.756|TWO_SIDED|95.0|0.649|35.956|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.096||Father's education level, junior high school vs postgraduate or above||35.956|0.649|0.756
70898149|NCT00952367|141284102|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.513||||0.179|TWO_SIDED|95.0|0.474|26.03|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=1.807||Father's education level, senior high school/vocational high school/technical secondary school vs postgraduate or above||26.030|0.474|0.179
70898150|NCT00952367|141284102|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.029||||0.077|TWO_SIDED|95.0|0.412|22.292|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=3.131||Father's education level, college/university vs postgraduate or above||22.292|0.412|0.077
70898151|NCT00952367|141284102|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.984||||0.056|TWO_SIDED|95.0|0.968|1.0|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=3.648||Living space per capita, continuous variables||1.000|0.968|0.056
70898152|NCT00952367|141284102|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.729||||0.064|TWO_SIDED|95.0|0.522|1.018|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=3.432||Vaccination history of Hib, no vs yes||1.018|0.522|0.064
70898153|NCT00952367|141284103|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.438||||0.019|TWO_SIDED|95.0|0.221|0.871|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=5.538||Birth information, preterm birth vs full-term birth||0.871|0.221|0.019
70898154|NCT00952367|141284103|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.546|||<|0.001|TWO_SIDED|95.0|0.423|0.703|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=21.938||Household register, local vs nonlocal||0.703|0.423|<0.001
70898155|NCT00952367|141284103|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.137||||0.559|TWO_SIDED|95.0|0.473|9.652|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.341||Mother's education level, illiteracy vs graduate or above||9.652|0.473|0.559
70898156|NCT00952367|141284103|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.793||||0.626|TWO_SIDED|95.0|0.596|5.394|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.238||Mother's education level, elementary school vs graduate or above||5.394|0.596|0.626
70898157|NCT00952367|141284103|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.972||||0.193|TWO_SIDED|95.0|0.699|5.562|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=1.691||Mother's education level, junior middle school vs graduate or above||5.562|0.699|0.193
70898158|NCT00952367|141284103|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.907||||0.298|TWO_SIDED|95.0|0.679|5.353|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=1.081||Mother's education level, senior high school/vocational high school/technical secondary school vs postgraduate or above||5.353|0.679|0.298
70898159|NCT00952367|141284103|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.233||||0.122|TWO_SIDED|95.0|0.439|3.464|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=2.395||Mother's education level, college/university vs postgraduate or above||3.464|0.439|0.122
70898160|NCT00952367|141284103|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.666||||0.001|TWO_SIDED|95.0|0.52|0.855|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=10.233||Whether have brothers or sisters, no vs yes||0.855|0.520|0.001
70898161|NCT05120115|141284109|EQUIVALENCE|Examined differences between conditions||||||0.05||||||Used Tukey Honestly Significant Difference post-hoc test|ANOVA|||||||0.05
70898162|NCT05120115|141284110|EQUIVALENCE|Differences between conditions||||||0.05||||||Used Tukey Honestly Significant Difference post-hoc test|Mixed Models Analysis|||||||0.05
70898163|NCT05120115|141284111|EQUIVALENCE|Differences between conditions||||||0.05||||||Used Tukey Honestly Significant Difference post-hoc test|Mixed Models Analysis|||||||0.05
70898164|NCT03882879|141284122|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||||||0.64
70898165|NCT03882879|141284123|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||||||0.53
70898166|NCT03882879|141284124|SUPERIORITY|||||||0.76||||||Between-group two-sided t-test|t-test, 2 sided|||||||0.76
70898167|NCT03882879|141284125|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||||||0.49
70898168|NCT03882879|141284126|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.20
70898169|NCT02954354|141284127|SUPERIORITY||Difference|-26.5|||<|0.0001|TWO_SIDED|95.0|-35.8|-17.8||Adjusted p-value, two-sided significance level of 0.05|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||The primary analysis of time to alleviation of symptoms was a comparison of baloxavir with placebo in all participants in the intention-to-treat infection population. Statistical tests were performed at the 0.05 significance level.||-17.8|-35.8|<0.0001
70898170|NCT02954354|141284127|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Log Rank|Log rank test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Analysis using the stratified log rank test was performed as a sensitivity analysis.||||<0.0001
70898171|NCT02954354|141284128|SUPERIORITY||Difference|-0.3||||0.756|TWO_SIDED|95.0|-6.6|6.6||Adjusted p-value, two-sided significance level of 0.05|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||A secondary analysis of time to alleviation of symptoms, consisting of a comparison between the 20 to 64 years of age stratum of the baloxavir group and the oseltamivir group, was conducted if statistical significance was observed in the primary analysis in order to maintain the overall Type I error.||6.6|-6.6|0.7560
70898172|NCT02954354|141284128|SUPERIORITY|||||||0.3761||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Log Rank|Log rank test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Analysis using the stratified log rank test was performed as a sensitivity analysis.||||0.3761
70898173|NCT02954354|141284129|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||<0.0001
70898174|NCT02954354|141284129|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||<0.0001
70898175|NCT02954354|141284129|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||<0.0001
70898176|NCT02954354|141284129|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||<0.0001
70898177|NCT02954354|141284129|SUPERIORITY|||||||0.4767||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.4767
70898178|NCT02954354|141284129|SUPERIORITY|||||||0.3353||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.3353
70898179|NCT02954354|141284130|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||<0.0001
70898180|NCT02954354|141284130|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||<0.0001
70898181|NCT02954354|141284130|SUPERIORITY|||||||0.0852||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||0.0852
70898182|NCT02954354|141284130|SUPERIORITY|||||||0.0063||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||0.0063
70898183|NCT02954354|141284130|SUPERIORITY|||||||0.6187||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.6187
70898184|NCT02954354|141284130|SUPERIORITY|||||||0.8637||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|||Day 9||||0.8637
70898185|NCT02954354|141284131|SUPERIORITY|||||||0.6145||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||0.6145
70898186|NCT02954354|141284131|SUPERIORITY|||||||0.2505||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||0.2505
70898187|NCT02954354|141284131|SUPERIORITY|||||||0.419||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||0.4190
70898188|NCT02954354|141284131|SUPERIORITY|||||||0.0095||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||0.0095
70898189|NCT02954354|141284131|SUPERIORITY|||||||0.7393||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.7393
70898190|NCT02954354|141284131|SUPERIORITY|||||||0.0049||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.0049
70898191|NCT02954354|141284132|SUPERIORITY|||||||0.2266||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||0.2266
70898192|NCT02954354|141284132|SUPERIORITY|||||||0.1379||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||0.1379
70898193|NCT02954354|141284132|SUPERIORITY|||||||0.5479||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||0.5479
70898194|NCT02954354|141284132|SUPERIORITY|||||||0.0241||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||0.0241
70898195|NCT02954354|141284132|SUPERIORITY|||||||0.0898||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.0898
70898196|NCT02954354|141284132|SUPERIORITY|||||||0.2548||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.2548
70898197|NCT02954354|141284133|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||<0.0001
70898198|NCT02954354|141284133|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||<0.0001
70898199|NCT02954354|141284133|SUPERIORITY|||||||0.0008||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||0.0008
70898200|NCT02954354|141284133|SUPERIORITY|||||||0.0132||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||0.0132
70898201|NCT02954354|141284133|SUPERIORITY|||||||0.9307||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.9307
70898202|NCT02954354|141284133|SUPERIORITY|||||||0.1677||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.1677
70898203|NCT02954354|141284134|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||<0.0001
70898204|NCT02954354|141284134|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||<0.0001
70898205|NCT02954354|141284134|SUPERIORITY|||||||0.801||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||0.8010
70898206|NCT02954354|141284134|SUPERIORITY|||||||0.9451||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||0.9451
70898207|NCT02954354|141284134|SUPERIORITY|||||||0.2256||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.2256
70898208|NCT02954354|141284134|SUPERIORITY|||||||0.3332||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.3332
70898209|NCT02954354|141284135|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||<0.0001
70898210|NCT02954354|141284135|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||<0.0001
70898211|NCT02954354|141284135|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||<0.0001
70898212|NCT02954354|141284135|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||<0.0001
70898213|NCT02954354|141284135|SUPERIORITY|||||||0.001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.0010
70898214|NCT02954354|141284135|SUPERIORITY|||||||0.0002||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.0002
70898215|NCT02954354|141284136|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||<0.0001
70898216|NCT02954354|141284136|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||<0.0001
70898217|NCT02954354|141284136|SUPERIORITY|||||||0.4148||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||0.4148
70898218|NCT02954354|141284136|SUPERIORITY|||||||0.0338||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||0.0338
70898219|NCT02954354|141284136|SUPERIORITY|||||||0.9619||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.9619
70898220|NCT02954354|141284136|SUPERIORITY|||||||0.8491||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.8491
70898221|NCT02954354|141284137|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||<0.0001
70898222|NCT02954354|141284138|SUPERIORITY|||||||0.0313||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.0313
70898223|NCT02954354|141284139|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||<0.0001
70898224|NCT02954354|141284140|SUPERIORITY|||||||0.2424||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.2424
70898225|NCT02954354|141284141|SUPERIORITY||Difference|-72.0|||<|0.0001|TWO_SIDED|95.0|-72.0|-48.0||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||-48.0|-72.0|<0.0001
70898226|NCT02954354|141284142|SUPERIORITY||Difference|-48.0|||<|0.0001|TWO_SIDED|95.0|-72.0|-24.0||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||-24.0|-72.0|<0.0001
70898227|NCT02954354|141284143|SUPERIORITY||Difference|-24.0||||0.002|TWO_SIDED|95.0|-120.0|0.0||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||0.0|-120.0|0.0020
70898228|NCT02954354|141284144|SUPERIORITY||Difference|-24.0||||0.0102|TWO_SIDED|95.0|-48.0|24.0||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||24.0|-48.0|0.0102
70898229|NCT02954354|141284145|SUPERIORITY|||||||0.5973||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||12 hours||||0.5973
70898230|NCT02954354|141284145|SUPERIORITY|||||||0.001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||24 hours||||0.0010
70898231|NCT02954354|141284145|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||36 hours||||<0.0001
70898232|NCT02954354|141284145|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||48 hours||||<0.0001
70898233|NCT02954354|141284145|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||72 hours||||<0.0001
70898234|NCT02954354|141284145|SUPERIORITY|||||||0.0115||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||96 hours||||0.0115
70898235|NCT02954354|141284145|SUPERIORITY|||||||0.1298||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||120 hours||||0.1298
70898236|NCT02954354|141284145|SUPERIORITY|||||||0.117||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||144 hours||||0.1170
70898237|NCT02954354|141284145|SUPERIORITY|||||||0.0757||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||168 hours||||0.0757
70898238|NCT02954354|141284145|SUPERIORITY|||||||0.9453||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||192 hours||||0.9453
70898239|NCT02954354|141284145|SUPERIORITY|||||||0.8657||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||216 hours||||0.8657
70898240|NCT02954354|141284146|SUPERIORITY|||||||0.0458||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||12 hours||||0.0458
70898241|NCT02954354|141284146|SUPERIORITY|||||||0.7565||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||24 hours||||0.7565
70898242|NCT02954354|141284146|SUPERIORITY|||||||0.3297||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||36 hours||||0.3297
70898243|NCT02954354|141284146|SUPERIORITY|||||||0.4442||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||48 hours||||0.4442
70898244|NCT02954354|141284146|SUPERIORITY|||||||0.6029||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||72 hours||||0.6029
70898245|NCT02954354|141284146|SUPERIORITY|||||||0.9881||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||96 hours||||0.9881
70898246|NCT02954354|141284146|SUPERIORITY|||||||0.9257||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||120 hours||||0.9257
70898247|NCT02954354|141284146|SUPERIORITY|||||||0.5317||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||144 hours||||0.5317
70898248|NCT02954354|141284146|SUPERIORITY|||||||0.2144||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||168 hours||||0.2144
70898249|NCT02954354|141284146|SUPERIORITY|||||||0.0413||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||192 hours||||0.0413
70898250|NCT02954354|141284146|SUPERIORITY|||||||0.0409||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||216 hours||||0.0409
70898251|NCT02954354|141284147|SUPERIORITY||Difference|-19.8|||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||<0.0001
70898252|NCT02954354|141284148|SUPERIORITY||Difference|-0.7||||0.4194||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.4194
70898253|NCT02954354|141284149|SUPERIORITY|The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Difference|-23.1|||<|0.0001|||||||Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||<0.0001
70898254|NCT02954354|141284150|SUPERIORITY||Difference|1.3||||0.4856||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.4856
70898255|NCT02954354|141284151|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7173|TWO_SIDED|95.0|-0.5|0.7||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||12 hours||0.7|-0.5|0.7173
70898256|NCT02954354|141284151|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.3||0.0009|TWO_SIDED|95.0|-1.7|-0.4||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||24 hours||-0.4|-1.7|0.0009
70898257|NCT02954354|141284151|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.4|-1.1||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||36 hours||-1.1|-2.4|<0.0001
70898258|NCT02954354|141284151|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.4|-1.2||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||48 hours||-1.2|-2.4|<0.0001
70898259|NCT02954354|141284151|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.0|-0.9||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||72 hours||-0.9|-2.0|<0.0001
70898260|NCT02954354|141284151|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.3||0.0001|TWO_SIDED|95.0|-1.5|-0.5||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||96 hours||-0.5|-1.5|0.0001
70898261|NCT02954354|141284151|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1979|TWO_SIDED|95.0|-0.8|0.2||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||120 hours||0.2|-0.8|0.1979
70898262|NCT02954354|141284151|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.1079|TWO_SIDED|95.0|-0.8|0.1||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||144 hours||0.1|-0.8|0.1079
70898263|NCT02954354|141284151|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.5805|TWO_SIDED|95.0|-0.6|0.3||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||168 hours||0.3|-0.6|0.5805
70898264|NCT02954354|141284151|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.8057|TWO_SIDED|95.0|-0.4|0.5||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||192 hours||0.5|-0.4|0.8057
70898265|NCT02954354|141284151|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9525|TWO_SIDED|95.0|-0.6|0.6||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||216 hours||0.6|-0.6|0.9525
70898266|NCT02954354|141284152|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.4091|TWO_SIDED|95.0|-0.3|0.8||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||12 hours||0.8|-0.3|0.4091
70898267|NCT02954354|141284152|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3073|TWO_SIDED|95.0|-0.3|0.8||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||24 hours||0.8|-0.3|0.3073
70898268|NCT02954354|141284152|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3465|TWO_SIDED|95.0|-0.8|0.3||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||36 hours||0.3|-0.8|0.3465
70898269|NCT02954354|141284152|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4285|TWO_SIDED|95.0|-0.3|0.7||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||48 hours||0.7|-0.3|0.4285
70898270|NCT02954354|141284152|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.6703|TWO_SIDED|95.0|-0.4|0.6||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||72 hours||0.6|-0.4|0.6703
70898271|NCT02954354|141284152|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.7187|TWO_SIDED|95.0|-0.3|0.5||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||96 hours||0.5|-0.3|0.7187
70898272|NCT02954354|141284152|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.135|TWO_SIDED|95.0|-0.1|0.7||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||120 hours||0.7|-0.1|0.1350
70898273|NCT02954354|141284152|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.7046|TWO_SIDED|95.0|-0.3|0.5||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||144 hours||0.5|-0.3|0.7046
70898274|NCT02954354|141284152|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.2765|TWO_SIDED|95.0|-0.2|0.6||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||168 hours||0.6|-0.2|0.2765
70898275|NCT02954354|141284152|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0274|TWO_SIDED|95.0|0.0|0.8||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||192 hours||0.8|0.0|0.0274
70898276|NCT02954354|141284152|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.6001|TWO_SIDED|95.0|-0.3|0.6||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||216 hours||0.6|-0.3|0.6001
70898277|NCT02954354|141284153|SUPERIORITY||Difference|-17.5|||<|0.0001|TWO_SIDED|95.0|-21.1|-11.9||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||-11.9|-21.1|<0.0001
70898278|NCT02954354|141284154|SUPERIORITY|||||||0.9225||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.9225
70898279|NCT02954354|141284155|SUPERIORITY|||||||0.7866||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||12 hours||||0.7866
70898280|NCT02954354|141284155|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||24 hours||||<0.0001
70898281|NCT02954354|141284155|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||36 hours||||<0.0001
70898282|NCT02954354|141284155|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||48 hours||||<0.0001
70898283|NCT02954354|141284155|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||72 hours||||<0.0001
70898284|NCT02954354|141284155|SUPERIORITY|||||||0.7044||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||96 hours||||0.7044
70898285|NCT02954354|141284155|SUPERIORITY|||||||0.8512||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||120 hours||||0.8512
70898286|NCT02954354|141284155|SUPERIORITY|||||||0.8783||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||144 hours||||0.8783
70898287|NCT02954354|141284155|SUPERIORITY|||||||0.8291||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||168 hours||||0.8291
70898288|NCT02954354|141284155|SUPERIORITY|||||||0.8644||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||192 hours||||0.8644
70898289|NCT02954354|141284155|SUPERIORITY|||||||0.9312||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||216 hours||||0.9312
70898290|NCT02954354|141284156|SUPERIORITY|||||||0.2953||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||12 hours||||0.2953
70898291|NCT02954354|141284156|SUPERIORITY|||||||0.5414||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||24 hours||||0.5414
70898292|NCT02954354|141284156|SUPERIORITY|||||||0.2079||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||36 hours||||0.2079
70898293|NCT02954354|141284156|SUPERIORITY|||||||0.7771||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world)||48 hours||||0.7771
70898294|NCT02954354|141284156|SUPERIORITY|||||||0.0215||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||72 hours||||0.0215
70898295|NCT02954354|141284156|SUPERIORITY|||||||0.8033||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world)||96 hours||||0.8033
70898296|NCT02954354|141284156|SUPERIORITY|||||||0.4157||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||120 hours||||0.4157
70898297|NCT02954354|141284156|SUPERIORITY|||||||0.5908||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world)||144 hours||||0.5908
70898298|NCT02954354|141284156|SUPERIORITY|||||||0.2975||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||168 hours||||0.2975
70898299|NCT02954354|141284156|SUPERIORITY|||||||0.8644||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||192 hours||||0.8644
70898300|NCT02954354|141284156|SUPERIORITY|||||||0.5573||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.m|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||216 hours||||0.5573
70898301|NCT02954354|141284157|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.08||0.2557|TWO_SIDED|95.0|-0.24|0.06||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||12 hours||0.06|-0.24|0.2557
70898302|NCT02954354|141284157|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.46|-0.22||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||24 hours||-0.22|-0.46|<0.0001
70898303|NCT02954354|141284157|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.52|-0.29||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||36 hours||-0.29|-0.52|<0.0001
70898304|NCT02954354|141284157|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.48|-0.27||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||48 hours||-0.27|-0.48|<0.0001
70898305|NCT02954354|141284157|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.31|-0.13||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||72 hours||-0.13|-0.31|<0.0001
70898306|NCT02954354|141284157|SUPERIORITY||LS Mean Dfference|-0.04|STANDARD_ERROR_OF_MEAN|0.05||0.4484|TWO_SIDED|95.0|-0.13|0.06||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||96 hours||0.06|-0.13|0.4484
70898307|NCT02954354|141284157|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.5963|TWO_SIDED|95.0|-0.07|0.11||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||0.11|-0.07|0.5963
70898308|NCT02954354|141284158|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.07||0.0937|TWO_SIDED|95.0|-0.02|0.24||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||12 hours||0.24|-0.02|0.0937
70898309|NCT02954354|141284158|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.3343|TWO_SIDED|95.0|-0.05|0.16||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||24 hours||0.16|-0.05|0.3343
70898310|NCT02954354|141284158|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.9258|TWO_SIDED|95.0|-0.09|0.1||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||36 hours||0.10|-0.09|0.9258
70898311|NCT02954354|141284158|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.6574|TWO_SIDED|95.0|-0.1|0.06||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||48 hours||0.06|-0.10|0.6574
70898312|NCT02954354|141284158|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.852|TWO_SIDED|95.0|-0.09|0.07||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||72 hours||0.07|-0.09|0.8520
70898313|NCT02954354|141284158|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.04||0.4532|TWO_SIDED|95.0|-0.05|0.11||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||96 hours||0.11|-0.05|0.4532
70898314|NCT02954354|141284158|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.04||0.157|TWO_SIDED|95.0|-0.02|0.13||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||120 hours||0.13|-0.02|0.1570
70898315|NCT02954354|141284159|SUPERIORITY||Difference|-23.1||||0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Cough||||0.0001
70898316|NCT02954354|141284159|SUPERIORITY||Difference|-9.0||||0.0298||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Sore throat||||0.0298
70898317|NCT02954354|141284159|SUPERIORITY||Difference|-11.8||||0.0297||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Headache||||0.0297
70898318|NCT02954354|141284159|SUPERIORITY||Difference|-20.7||||0.0027||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Nasal Congestion||||0.0027
70898319|NCT02954354|141284159|SUPERIORITY||Difference|-4.9||||0.0003||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world)||Feverishness or chills||||0.0003
70898320|NCT02954354|141284159|SUPERIORITY||Difference|-8.1||||0.0094||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Muscle or joint pain||||0.0094
70898321|NCT02954354|141284159|SUPERIORITY||Difference|-15.3||||0.0007||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Fatigue||||0.0007
70898322|NCT02954354|141284160|SUPERIORITY||Difference|6.8||||0.6623||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Cough||||0.6623
70898323|NCT02954354|141284160|SUPERIORITY||Difference|1.8||||0.8184||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Sore throat||||0.8184
70898324|NCT02954354|141284160|SUPERIORITY||Difference|1.3||||0.9989||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Headache||||0.9989
70898325|NCT02954354|141284160|SUPERIORITY||Difference|1.7||||0.3706||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Nasal congestion||||0.3706
70898326|NCT02954354|141284160|SUPERIORITY||Difference|-0.1||||0.9973||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Feverishness or chills||||0.9973
70898327|NCT02954354|141284160|SUPERIORITY||Difference|-0.7||||0.676||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Muscle or joint pain||||0.6760
70898328|NCT02954354|141284160|SUPERIORITY||Difference|2.2||||0.4241||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Fatigue||||0.4241
70898329|NCT02954354|141284161|SUPERIORITY|The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Difference|-39.5||||0.0563|||||||Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.0563
70898330|NCT02954354|141284162|SUPERIORITY||Difference|-0.6||||0.7176||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.7176
70898331|NCT02954354|141284163|SUPERIORITY|||||||0.6728||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact|||Any Complications||||0.6728
70898332|NCT02954354|141284164|SUPERIORITY|||||||0.2217||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact|||Any Complications||||0.2217
70898333|NCT01812655|141284212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.7||||0.029|TWO_SIDED|95.0|2.4|45.0|||Regression, Linear||Mean difference = PD group - VR group|||45.0|2.4|0.029
70898334|NCT01812655|141284212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7||||0.32|TWO_SIDED|95.0|-9.5|28.9|||Regression, Linear||Mean difference = VR group - SC group|||28.9|-9.5|0.32
70898335|NCT01812655|141284213|SUPERIORITY_OR_OTHER||Semipartial correlation|0.223||||0.26||95.0|||||Semipartial correlation||Semipartial correlation between desire for distraction and STAIC State Anxiety measured at Baseline for all participants|||||.26
70898336|NCT01812655|141284213|SUPERIORITY_OR_OTHER||Semipartial correlation|0.119||||0.59||95.0|||||Semipartial correlation||Semipartial correlation between desire for distraction and STAIC Trait Anxiety measured at Baseline for all participants|||||.59
70898337|NCT01812655|141284213|SUPERIORITY_OR_OTHER||Semipartial correlation|-0.059||||0.6||95.0|||||Semipartial correlation||Semipartial correlation between desire for distraction and Procedural Pain (Outcome Measure #1) for all participants|||||.60
70898338|NCT01812655|141284214|SUPERIORITY_OR_OTHER||semipartial correlation|-0.276||||0.15||95.0|||||Semipartial Correlation||Semipartial correlation between Engagement with Distraction and STAIC State Anxiety measured at Baseline for all participants|||||0.15
70898339|NCT01812655|141284214|SUPERIORITY_OR_OTHER||Semipartial correlation|-0.347||||0.18||95.0|||||Semipartial correlation||Semipartial correlation between Engagement with Distraction and STAIC Trait Anxiety measured at Baseline for all participants|||||0.18
70898340|NCT01812655|141284214|SUPERIORITY_OR_OTHER||Semipartial correlation|0.21||||0.054||95.0|||||Semipartial correlation||Semipartial correlation between Engagement with Distraction and Procedural Pain (Outcome Measure #1) for all participants|||||0.054
70898341|NCT01812655|141284214|SUPERIORITY_OR_OTHER||Semipartial Correlation|-0.102||||0.61||95.0|||||Semipartial Correlation||Semipartial correlation between Belief in Distraction's Efficacy and STAIC State Anxiety measured at Baseline for all participants|||||0.61
70898342|NCT01812655|141284214|SUPERIORITY_OR_OTHER||Semipartial Correlation|-0.622||||0.007||95.0|||||Semipartial Correlation||Semipartial correlation between Belief in Distraction's Efficacy and STAIC Trait Anxiety measured at Baseline for all participants|||||0.007
70898343|NCT01812655|141284214|SUPERIORITY_OR_OTHER||Semipartial correlation|-0.217||||0.045||95.0|||||Semipartial correlation||Semipartial correlation between Belief in Distraction's Efficacy and Procedural Pain (Outcome Measure #1) for all participants|||||0.045
70898344|NCT05725317|141284238|NON_INFERIORITY|Noninferiority in distance visual acuity was declared if the upper confidence limit was less than 0.05.|LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.004|||ONE_SIDED|95.0||0.0||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, visit, lens-by-visit interaction and sequence) and random (subject) effects. Difference = LID220365 minus LID006961. Sign is retained with the rounded value.|||0.00||
70898345|NCT03063294|141284245|SUPERIORITY||Difference in Difference|0.02|||||TWO_SIDED|95.0|-0.47|0.5|||||"The difference in difference equals the follow-up minus baseline change in Hassles scale results for the toolkit plus coaching clinics, minus the follow-up minus baseline change in the Hassles scale results for the toolkit only clinics."|"Zero-inflated negative binomial regression was used to obtain predicted mean Hassles scale scores for the toolkit only clinics and toolkit plus coaching clinics at baseline and follow-up, adjusting for study design and characteristics of survey respondents. The difference-in-difference was then computed as described below, under method of estimation. Bootstrap resampling was used to calculate the 95% confidence intervals around the predicted means and the difference-in-difference."||0.50|-0.47|
70898346|NCT01971723|141284261|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED||||||ANOVA|Groups were compared against each other at the two different time points and against themselves at the same time points.||This statistical analysis is for the squat one repetition maximum outcomes, only.||||.38
70898347|NCT01971723|141284261|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANOVA|||This statistical analysis is for the bench press one repetition maximum outcomes, only.||||0.0001
70898348|NCT01971723|141284261|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||ANOVA|||This statistical analysis is for the deadlift one repetition maximum measures, only.||||.3
70898349|NCT01971723|141284261|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANOVA|||This statistical analysis compares the outcomes of the total weight lifted.||||0.0001
70898350|NCT01971723|141284262|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
70898351|NCT01971723|141284263|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||This statistical measurement is for cholesterol measure outcomes, only.||||>.05
70898352|NCT01971723|141284263|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||This statistical analysis is for glucose measure outcomes, only.||||>.05
70898353|NCT01971723|141284263|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||This statistical analysis is for HDL measure outcomes, only.||||>.05
70898354|NCT01971723|141284263|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||This statistical analysis is for LDL measure outcomes, only.||||>.05
70898355|NCT01971723|141284263|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||This statistical analysis for the triglyceride measure outcomes, only.||||>.05
70898356|NCT01971723|141284264|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
70898357|NCT01971723|141284265|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
70898358|NCT01971723|141284266|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
70898359|NCT01971723|141284267|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
70898360|NCT01971723|141284268|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
70898361|NCT01971723|141284269|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>.05
70898362|NCT01971723|141284270|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is for deadlift volume measure outcomes, only.||||>.05
70898363|NCT01971723|141284270|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is for auxiliary squat volume measure outcomes, only.||||>.05
70898364|NCT01971723|141284270|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||This statistical analysis is for squat volume measure outcomes, only.||||>.05
70898365|NCT01971723|141284270|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is for bench volume measure outcomes, only.||||>.05
70898366|NCT01971723|141284270|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is for total squat volume measures, only.||||>.05
70898367|NCT01971723|141284270|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is for total weight lifted volume measure outcomes, only.||||>.05
70898368|NCT01971723|141284271|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
70898369|NCT01971723|141284272|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
70898370|NCT01971723|141284273|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||ANOVA|||||||.05
70898371|NCT05899686|141284274|EQUIVALENCE|Equivalence was defined as ANOVA p\<0.05||||||0.65|||||||ANOVA|||Maximum percent change from baseline (light transmittance) during 60 heart beats after the tetanic stimulus were compared between the three stimulus locations using ANOVA||||0.65
70898372|NCT01111123|141284352|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||CI of 95%|Log Rank|||Probabilities of PGA not worsening were estimated using the Kaplan-Meier product limit method with a comparison between treatment group survival curves evaluated by the log-rank test statistic. The Cox proportional hazards model was used to estimate the hazard ratio for worsening of PGA (equivalent to a relative risk adjusted for follow-up time) and a corresponding 95-percent confidence interval.||||<0.05
70898373|NCT01111123|141284353|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||Secondary outcomes, including subject self-assessment and signs of psoriasis ratings, were analyzed as continuous dependent variables in these statistical models. Mixed modeling analysis of covariance (ANCOVA) was used to compare the relationships between psoriasis symptoms over time in the placebo and steroid treatment groups||||<0.05
70898374|NCT03896009|141284369|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
70898375|NCT03896009|141284370|SUPERIORITY|||||||0.002|||||||Chi-squared|||||||0.002
70898376|NCT03073148|141284377|EQUIVALENCE|alpha = 0.05||||||0.3577|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.3577
70898377|NCT03073148|141284377|EQUIVALENCE|alpha = 0.05||||||0.9917|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.9917
70898378|NCT03073148|141284378|EQUIVALENCE|alpha = 0.05||||||0.3239|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.3239
70898379|NCT03073148|141284378|EQUIVALENCE|alpha = 0.05||||||0.8343|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.8343
70898380|NCT03073148|141284379|EQUIVALENCE|alpha = 0.05||||||0.4134|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.4134
70898381|NCT03073148|141284379|EQUIVALENCE|alpha = 0.05||||||0.1192|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.1192
70898382|NCT03073148|141284381|EQUIVALENCE|alpha = 0.05||||||0.1753||||||Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.|ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.1753
70898383|NCT03073148|141284381|EQUIVALENCE|alpha = 0.05||||||0.1843|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.1843
70898384|NCT03073148|141284382|EQUIVALENCE|alpha = 0.05||||||0.0765|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.0765
70898385|NCT03073148|141284382|EQUIVALENCE|alpha = 0.05||||||0.152|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.1520
70898386|NCT02052310|141284395|NON_INFERIORITY|Non-inferiority was established if the 2-sided 95% confidence interval (CI) for the treatment difference in least square (LS) means from MI ANCOVA model between the 2 treatment groups lay entirely above -0.75 g/dL.|LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.053||0.0005|TWO_SIDED|95.0|0.079|0.287|||ANCOVA|ANCOVA with multiple imputation||Treatment comparison was made using the multiple imputation (MI) strategy by combining the results of analysis of covariance (ANCOVA) model with baseline Hb as a covariate, and treatment, region and cardiovascular/cerebrovascular/thromboembolic medical history (yes vs. no) as factors.||0.287|0.079|0.0005
70898387|NCT02052310|141284396|NON_INFERIORITY|Non-inferiority was established if the lower bound of the 2-sided 95% CI for the treatment difference for the responder rates (roxadustat minus epoetin alfa) calculated based on the Miettinen \& Nurminen approach, adjusting for stratification factors, was greater than -15%.|Responder Rate Difference|3.5|||||TWO_SIDED|95.0|-0.7|7.7||||||For the difference of responder rates between 2 treatment groups, the CI was analyzed from the Miettinen \& Nurminen approach adjusting for randomization stratification factors.||7.7|-0.7|
70898388|NCT02052310|141284397|NON_INFERIORITY|Non-inferiority was established if the lower bound of the 2-sided 95% CI for the treatment difference for the responder rates (roxadustat minus epoetin alfa) calculated based on the Miettinen \& Nurminen approach, adjusting for stratification factors, was greater than -15%.|Responder Rate Difference|4.3|||||TWO_SIDED|95.0|-0.1|8.7||||||For the difference of responder rates between 2 treatment groups, the CI analyzed was from the Miettinen \& Nurminen approach adjusting for randomization stratification factors.||8.7|-0.1|
70898389|NCT02052310|141284398|NON_INFERIORITY|Non-inferiority was established if the 2-sided 95% CI for the treatment difference in LS means of change from baseline Hb averaged over Weeks 28 to 52 lay entirely above -0.75 g/dL.|LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.067||0.0148|TWO_SIDED|95.0|0.032|0.296|||Mixed Models Analysis|||Treatment comparison was made using mixed model for repeated measures (MMRM) with baseline Hb as a covariate, and treatment, visit, visit-by-treatment interaction and randomization stratification factors except mean qualifying screening hemoglobin (≤8.0 vs. \>8.0 g/dL) as fixed effects.||0.296|0.032|0.0148
70898390|NCT02052310|141284399|SUPERIORITY|Superiority was declared if the upper bound of the 2-sided 95% CI of the difference between roxadustat and epoetin alfa (roxadustat - epoetin alpha) was less than 0.|LS Mean Difference|-18.34|STANDARD_ERROR_OF_MEAN|1.584|<|0.0001|TWO_SIDED|95.0|-21.448|-15.232|||Mixed Models Analysis|||Treatment comparison was made using a MMRM with baseline LDL cholesterol as a covariate, and treatment, visit, visit-by-treatment interaction and randomization stratification factors as fixed effects.||-15.232|-21.448|<0.0001
70898391|NCT02052310|141284400|NON_INFERIORITY|The non-inferiority margin was fixed as a difference of -0.75.|LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.099||0.8178|TWO_SIDED|95.0|-0.171|0.217|||ANCOVA|ANCOVA multiple imputation||Treatment comparison was made using the multiple imputation strategy by combining the results of ANCOVA model with baseline Hb as a covariate, and treatment, region and cardiovascular/cerebrovascular/thromboembolic medical history (yes vs. no) as factors.||0.217|-0.171|0.8178
70898392|NCT02052310|141284401|SUPERIORITY|||||||0.00028||||||Threshold for significance at 0.05 level.|Rank ANCOVA|||Treatment comparison was made using an ANCOVA model with baseline iron repletion status, treatment, and randomization stratification factors as fixed effects.||||0.00028
70898393|NCT02052310|141284402|NON_INFERIORITY|The non-inferiority margin for the difference between groups was 1.8.|Hazard Ratio (HR)|1.26||||0.3284|TWO_SIDED|95.0|0.791|2.016|||Cox Proportional Hazards model|||Analysis was done using a Cox Proportional Hazards model adjusting for baseline Hb and other stratification factors except mean qualifying screening hemoglobin (\<= 8.0 vs. \>8.0 g/dL) as fixed effects.||2.016|0.791|0.3284
70898394|NCT00420199|141284422|SUPERIORITY_OR_OTHER||Adjusted Mean Difference from Placebo|-0.5|||||TWO_SIDED|95.0|-1.77|0.76|||ANCOVA|||Comparison in the change from baseline of erosion score using the OMERACT 6 RA MRI score method between Abatacept and Placebo at Day 113 was based on a non-parametric analysis of covariance model (ANCOVA). Change from BL = Post-BL measurement-BL value. Adjustment was based on ANCOVA model with treatment as a factor and BL value a covariate.||0.76|-1.77|
70898395|NCT00420199|141284423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96||||0.103||95.0|||||ANCOVA|||Comparison in change from baseline of wrist synovitis using OMERACT 6 rheumatoid arthritis magnetic resonance imaging score method between abatacept and placebo at Day 113 based on a nonparametric analysis of covariance model. Baseline and changes from baseline of the total wrist synovitis scores were ranked, and the model included the rank score for change from baseline as the dependent variable with treatment group as a main effect and the rank score for baseline as an additional covariate.||||0.103
70898396|NCT00420199|141284425|SUPERIORITY_OR_OTHER||Adjusted Mean Difference from Placebo|-3.48|||||TWO_SIDED|95.0|-6.0|-0.96|||ANCOVA|||Comparison in the change from baseline of Edema/Osteitis score using the OMERACT 6 RA MRI score method between Abatacept and Placebo at Day 113 was based on a non-parametric analysis of covariance model (ANCOVA). Change from BL = Post-BL measurement-BL value. Adjustment was based on ANCOVA model with treatment as a factor and BL value a covariate.||-0.96|-6.00|
70898397|NCT00420199|141284428|SUPERIORITY_OR_OTHER||Adjusted Mean Difference from Placebo|-4.71|||||TWO_SIDED|95.0|-8.0|-1.42|||ANCOVA|||Comparison in the change from baseline of RAMRIS score using the OMERACT 6 RA MRI score method between Abatacept and Placebo at Day 113 was based on a non-parametric analysis of covariance model (ANCOVA). Change from BL = Post-BL measurement-BL value. Adjustment was based on ANCOVA model with treatment as a factor and BL value a covariate.||-1.42|-8.00|
70898398|NCT00420199|141284442|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.69||||0.078||95.0|||||ANCOVA|||Comparison in change from baseline of wrist synovitis using OMERACT 6 rheumatoid arthritis magnetic resonance imaging (MRI) score method between ABA and PLA at Day 113 based on a parametric analysis of covariance model (ANCOVA). The model included the score change from baseline as the dependent variable, treatment group as a main effect and baseline score as an additional covariate.||||0.078
70898399|NCT03387579|141284445|SUPERIORITY|||||||0.59|||||||Fisher Exact|||||||0.590
70898400|NCT03387579|141284445|SUPERIORITY|||||||0.224|||||||Fisher Exact|||||||0.224
70898401|NCT03387579|141284445|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
70898402|NCT03387579|141284446|SUPERIORITY|||||||0.471|||||||Kruskal-Wallis|||||||0.471
70898403|NCT03387579|141284447|SUPERIORITY|||||||0.525|||||||Kruskal-Wallis|||||||0.525
70898404|NCT03387579|141284448|SUPERIORITY|||||||0.753|||||||Kruskal-Wallis|||||||0.753
70898405|NCT03387579|141284449|SUPERIORITY|||||||0.008|||||||Kruskal-Wallis|||||||0.008
70898406|NCT03387579|141284450|SUPERIORITY|||||||0.127|||||||Fisher Exact|||||||0.127
70898407|NCT03387579|141284451|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
70898408|NCT03387579|141284452|SUPERIORITY||estimate|8.553||||0.046|TWO_SIDED|||||Intralipid 20% reduction versus smoflipid 20%|Mixed Models Analysis||standard error 4.249|||||0.046
70898409|NCT03387579|141284452|SUPERIORITY||estimate|7.023||||0.04|TWO_SIDED|||||Intralipid 20% historic versus smoflipid|Mixed Models Analysis||standard error 3.376|||||0.040
70898410|NCT03387579|141284452|SUPERIORITY||estimate|-1.53||||0.718|TWO_SIDED|||||Intralipid 20% Historic versus Intralipid 20% reduction|Mixed Models Analysis||standard error 4.231|||||0.718
70898411|NCT03387579|141284453|SUPERIORITY||estimate|13.436||||0.003|TWO_SIDED|||||Intralipid 20% reduction versus Smoflipid 20%|Mixed Models Analysis||standard error 4.440|||||0.003
70898412|NCT03387579|141284453|SUPERIORITY||estimate|3.936||||0.27|TWO_SIDED|||||Intralipid 20% historic versus Smoflipid 20%|Mixed Models Analysis||standard error 3.553|||||0.270
70898413|NCT03387579|141284453|SUPERIORITY||estimate|-9.5||||0.034|TWO_SIDED|||||Intralipid 20% historic versus Intralipid 20% reduction|Mixed Models Analysis||standard error 4.416|||||0.034
70898414|NCT03387579|141284454|SUPERIORITY||estimate|42.674||||0.006|TWO_SIDED|||||Intralipid 20% reduction versus Smoflipid 20%|Mixed Models Analysis||standard error 15.216|||||0.006
70898415|NCT03387579|141284454|SUPERIORITY||estimate|11.117||||0.305|TWO_SIDED|||||Intralipid 20% historic versus smoflipid 20%|Mixed Models Analysis||standard error 10.771|||||0.305
70898416|NCT03387579|141284454|SUPERIORITY||estimate|-31.557|||<|0.001|TWO_SIDED|||||Intralipid 20% historic versus Intralipid 20% reduction|Mixed Models Analysis||standard error 67.673|||||<0.001
70898417|NCT03387579|141284455|SUPERIORITY||estimate|-0.593||||0.835|TWO_SIDED|||||Intralipid 20% reduction versus smoflipid 20%|Mixed Models Analysis||standard error 2.848|||||0.835
70898418|NCT03387579|141284455|SUPERIORITY||estimate|-0.522||||0.799|TWO_SIDED|||||Intralipid 20% historic versus smoflipid 20%|Mixed Models Analysis||standard error 2.050|||||0.799
70898419|NCT03387579|141284455|SUPERIORITY||estimate|0.714||||0.714|TWO_SIDED|||||Intralipid 20% historic versus Intralipid 20% reduction|Mixed Models Analysis||standard error 2.758|||||0.714
70898420|NCT03387579|141284456|SUPERIORITY||estimate|11.162||||0.379|TWO_SIDED||||||Mixed Models Analysis|Intralipid 20% reduction versus smoflipid 20%|standard error 12.626|||||0.379
70898421|NCT03387579|141284456|SUPERIORITY||estimate|3.853||||0.717|TWO_SIDED|||||Intralipid 20% historic versus smoflipid 20%|Mixed Models Analysis||standard error 10.615|||||0.717
70898422|NCT03387579|141284456|SUPERIORITY|Intralipid 20% historic versus intralipid 20% reduction|estimate|-7.31||||0.576|TWO_SIDED||||||Mixed Models Analysis||standard error 13.025|||||0.576
70898423|NCT03387579|141284457|SUPERIORITY|||||||1|||||||Fisher Exact|||ROP||||1.00
70898424|NCT03387579|141284457|SUPERIORITY|||||||1|||||||Fisher Exact|||ROP||||1.00
70898425|NCT03387579|141284458|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
70898426|NCT03387579|141284458|SUPERIORITY|||||||0.64|||||||Fisher Exact|||||||0.640
70898427|NCT03387579|141284458|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
70898428|NCT03387579|141284459|SUPERIORITY|||||||0.211|||||||Kruskal-Wallis|||||||0.211
70898429|NCT03387579|141284460|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.720
70898430|NCT03387579|141284461|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.500
70898431|NCT03387579|141284462|SUPERIORITY|||||||0.774|||||||t-test, 2 sided|||||||0.774
70898432|NCT03387579|141284463|SUPERIORITY|||||||0.457|||||||Wilcoxon (Mann-Whitney)|||||||0.457
70898433|NCT03387579|141284464|SUPERIORITY|||||||0.475|||||||Wilcoxon (Mann-Whitney)|||||||0.475
70898434|NCT03466086|141284465|SUPERIORITY|This was a pilot study and the sample size was not based on any empirical power calculation.|Mean Difference (Final Values)|0.13|STANDARD_DEVIATION|1.238|||TWO_SIDED|95.0|-2.35|2.59||Superiority will be declared if the lower bound of the 2-sided 95% credible interval of the difference between Test and Control is greater than 0.|Multivariate Bayesian Model|The correlation between measurements across periods were modeled using unstructured variance-covariance matrix.|Mean Difference was calculated as Test minus Control.|||2.59|-2.35|
70898435|NCT03466086|141284466|SUPERIORITY|Superiority will be declared if the lower bound of the 2-sided 95% credible interval of the difference between Test and Control is less than 0.|Mean Difference (Final Values)|1.49|STANDARD_DEVIATION|0.951|||TWO_SIDED|95.0|-0.4|3.37|||Multivariate Bayesian Analysis|The correlation between measurements across periods were modeled using unstructured variance-covariance matrix.||This was a pilot study and the sample size was not based on any empirical power calculation.|Mean difference was calculated as Test - Control|3.37|-0.40|
70898436|NCT04020341|141284484|NON_INFERIORITY|The difference in success rate between treatment groups (gepotidacin - nitrofurantoin) was calculated using Miettinen-Nurminen Summary Score Method adjusted for age group and acute cystitis recurrence strata combinations. Criteria for non-inferiority is if the Z-statistic for non-inferiority is greater than the Z-statistic boundary (2.065).|Adjusted Difference in Percent|4.3|||||TWO_SIDED|95.0|-3.6|12.1|||||||Observed Z statistic value for Noninferiority was 3.5554.|12.1|-3.6|
70898437|NCT04020341|141284484|SUPERIORITY|The difference in success rate between treatment groups (gepotidacin - nitrofurantoin) was calculated using Miettinen-Nurminen Summary Score Method adjusted for age group and acute cystitis recurrence strata combinations. Criteria for superiority is if the one-sided p-value is less than the 0.019 p-value boundary.|Adjusted difference of Percent|4.3||||0.1445|TWO_SIDED|95.0|-3.6|12.1|||1-sided p-value for Test of Superiority|||||12.1|-3.6|0.1445
70898438|NCT00677352|141284519|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sertraline was concluded to be non-inferior to paroxetine when the upper limit of the CI fell below the non-inferiority margin of 4.|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.5|1.6|||ANCOVA|||The two-sided 95% confidence interval (CI) of the intergroup difference (sertraline group - paroxetine group) of the mean reduction in the PAS total score at each dose during the treatment phase was calculated using an analysis of covariance (ANCOVA) model with treatment group as a factor and baseline PAS total score as a covariate.||1.6|-2.5|
70898439|NCT00677352|141284525|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0062|TWO_SIDED|||||The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05 (two-sided).|Fisher Exact|||||||0.0062
70898440|NCT00716092|141284527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.9|STANDARD_ERROR_OF_MEAN|4.0|<|0.0001||95.0|-28.0|-11.9||There was no adjustment for multiple primary endpoints, however a hierarchy approach to control for the Type-I error was used. If the endpoint WMG was not successful, any analysis of the GLP-1 (AUEC 0-24h) was to be considered descriptive.|ANCOVA|The primary analyses are based upon a model containing only BI1356 and Placebo. Sitagliptin values come from a different model containing all 3 groups||BI1356 minus Placebo||-11.9|-28.0|<0.0001
70898441|NCT00716092|141284528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.1|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001||95.0|12.4|23.9||There was no adjustment for multiple primary endpoints, however a hierarchy approach to control for the Type-I error was used. If the endpoint WMG was not successful, any analysis of the GLP-1 (AUEC 0-24h) will be considered descriptive.|ANCOVA|The primary analyses are based upon a model containing only BI1356 and Placebo. Sitagliptin values come from a different model containing all 3 groups||BI1356 minus Placebo||23.9|12.4|<0.0001
70898442|NCT00716092|141284529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|STANDARD_ERROR_OF_MEAN|4.8||0.0283||95.0|-20.4|-1.2|||ANCOVA|The primary analyses are based upon a model containing only BI1356 and Placebo. Sitagliptin values come from a different model containing all 3 groups||BI1356 minus Placebo||-1.2|-20.4|0.0283
70898443|NCT00716092|141284530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-106.5|STANDARD_ERROR_OF_MEAN|20.3|<|0.0001||95.0|-147.0|-66.0|||ANCOVA|The primary analyses are based upon a model containing only BI1356 and Placebo. Sitagliptin values come from a different model containing all 3 groups||BI1356 minus Placebo||-66.0|-147.0|<0.0001
70898444|NCT00716092|141284531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0|STANDARD_ERROR_OF_MEAN|3.9||0.1274||95.0|-1.7|13.8|||ANCOVA|These measured values and statistical analysis come from a mixed model containing all three treatment groups, and adjusted as already described.||BI 1356 minus Sitagliptin. This analysis comparing BI1356 to Sitagliptin was conducted as an exploratory analysis at the time of analysing the study data. The study was not powered for such a comparison.||13.8|-1.7|0.1274
70898445|NCT00716092|141284532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|2.7||0.313||95.0|-2.7|8.2|||ANCOVA|These measured values and statistical analysis come from a mixed model containing all three treatment groups, and adjusted as already described.||BI 1356 minus Sitagliptin. This analysis comparing BI1356 to Sitagliptin was conducted as an exploratory analysis at the time of analysing the study data. The study was not powered for such a comparison.||8.2|-2.7|0.3130
70898446|NCT00716092|141284533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|4.3||0.2281||95.0|-3.3|13.8|||ANCOVA|These measured values and statistical analysis come from a mixed model containing all three treatment groups, and adjusted as already described.||BI 1356 minus Sitagliptin. This analysis comparing BI1356 to Sitagliptin was conducted as an exploratory analysis at the time of analysing the study data. The study was not powered for such a comparison.||13.8|-3.3|0.2281
70898447|NCT00716092|141284534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.7|STANDARD_ERROR_OF_MEAN|18.6||0.223||95.0|-14.0|59.5|||ANCOVA|These measured values and statistical analysis come from a mixed model containing all three treatment groups, and adjusted as already described.||BI 1356 minus Sitagliptin. This analysis comparing BI1356 to Sitagliptin was conducted as an exploratory analysis at the time of analysing the study data. The study was not powered for such a comparison.||59.5|-14.0|0.2230
70898448|NCT00781391|141284536|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary|Hazard Ratio (HR)|0.79|||<|0.0001|TWO_SIDED|97.5|0.632|0.985||Two stratification factor covariates: 1) CHADS2 score 2) dose-adjustment factor. If upper limit of CI of HR was below 1.38, then non-inferiority to warfarin was established for group.|Cox proportional hazards model|||The primary efficacy endpoint, time to the first occurrence of stroke/SEE, was first compared concurrently between each of the 2 edoxaban groups and warfarin group using the mITT Analysis Set in the on-treatment period for non-inferiority. In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively.||.985|.632|<.0001
70898449|NCT00781391|141284536|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary|Hazard Ratio (HR)|1.07||||0.0055|TWO_SIDED|97.5|0.874|1.314||Two stratification factor covariates: 1) CHADS2 score 2) dose-adjustment factor. If upper limit of CI of HR was below 1.38, then non-inferiority to warfarin was established for group.|Cox proportional hazards model|||The primary efficacy endpoint, time to the first occurrence of stroke/SEE, was first compared concurrently between each of the 2 edoxaban groups and warfarin group using the mITT Analysis Set in the on-treatment period for non-inferiority. In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively.||1.314|.874|.0055
70898450|NCT00781391|141284537|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of this CI of the hazard ratio was below 1.38, then non-inferiority to warfarin was considered established for the edoxaban treatment group.|Hazard Ratio (HR)|0.86|||<|0.0001|TWO_SIDED|97.5|0.719|1.029|||Cox proportional hazards model|||Non-inferiority or equivalence analysis; Non-inferiority analysis. The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary.||1.029|.719|<.0001
70898451|NCT00781391|141284537|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of this CI of the hazard ratio was below 1.38, then non-inferiority to warfarin was considered established for the edoxaban treatment group.|Hazard Ratio (HR)|1.13||||0.0074|TWO_SIDED|97.5|0.955|1.336|||Cox proportional hazards model|||Non-inferiority or equivalence analysis; Non-inferiority analysis. The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary.||1.336|.955|.0074
70898452|NCT00781391|141284538|NON_INFERIORITY_OR_EQUIVALENCE|The primary efficacy endpoint, time to the first occurrence of stroke/SEE, was first compared concurrently between each of the 2 edoxaban groups and warfarin group using the mITT Analysis Set in the on-treatment period for non-inferiority. In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively|Hazard Ratio (HR)|0.79|||<|0.0001|TWO_SIDED|97.5|0.634|0.989|||Cox proportional hazards model|||The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary.||.989|.634|<.0001
70898453|NCT00781391|141284538|NON_INFERIORITY_OR_EQUIVALENCE|The primary efficacy endpoint, time to the first occurrence of stroke/SEE, was first compared concurrently between each of the 2 edoxaban groups and warfarin group using the mITT Analysis Set in the on-treatment period for non-inferiority. In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively.|Hazard Ratio (HR)|1.08||||0.0064|TWO_SIDED|97.5|0.878|1.32|||Cox proportional hazards model|||The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary.||1.32|.878|.0064
70898454|NCT00781391|141284539|NON_INFERIORITY_OR_EQUIVALENCE|"In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively.~If the upper limit of this CI of the hazard ratio was below 1.38, then non-inferiority to warfarin was considered established for the edoxaban treatment group."|Hazard Ratio (HR)|0.86|||<|0.0001|TWO_SIDED|97.5|0.72|1.032|||Cox proportional hazards model|||The non-inferiority analysis included the mITT and PP analysis sets for both the on-treatment and overall study period, although mITT on-treatment was considered primary.||1.032|.720|<.0001
70898455|NCT00781391|141284539|NON_INFERIORITY_OR_EQUIVALENCE|"In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively.~If the upper limit of this CI of the hazard ratio was below 1.38, then non-inferiority to warfarin was considered established for the edoxaban treatment group."|Hazard Ratio (HR)|1.13||||0.0084|TWO_SIDED|97.5|0.958|1.34|||Cox proportional hazards model|||The non-inferiority analysis included the mITT and PP analysis sets for both the on-treatment and overall study period, although mITT on-treatment was considered primary.||1.34|.958|.0084
70898456|NCT00781391|141284540|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.081|TWO_SIDED|99.0|0.709|1.068|||Log Rank|||The superiority analysis included the ITT analysis set||1.068|.709|.081
70898457|NCT00781391|141284541|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.0053|TWO_SIDED|95.0|0.786|0.959|||Log Rank|||the time to first event was estimated by a KM estimate and was compared between the edoxaban 60 mg group and the warfarin group using a log-rank test at a pairwise comparison significance level of α=0.01.||.959|.786|.0053
70898458|NCT00781391|141284542|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.0109|TWO_SIDED|95.0|0.806|0.972|||Log Rank|||the time to first event was estimated by a KM estimate and was compared between the edoxaban 60 mg group and the warfarin group using a log-rank test at a pairwise comparison significance level of α=0.01.||.972|.806|.0109
70898459|NCT00781391|141284543|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.0168|TWO_SIDED|95.0|0.823|0.981|||Log Rank|||the time to first event was estimated by a KM estimate and was compared between the edoxaban 60 mg group and the warfarin group using a log-rank test at a pairwise comparison significance level of α=0.01.||.981|.823|.0168
70898460|NCT00781391|141284544|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8||||0.0009|TWO_SIDED|95.0|0.707|0.914|||Regression, Cox|||All Major Adjudicated Bleeding Events, Safety Analysis Set On-treatment period||.914|.707|.0009
70898461|NCT00781391|141284544|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.47|||<|0.0001|TWO_SIDED|95.0|0.406|0.548|||Regression, Cox|||"All Major Adjudicated Bleeding Events, Safety Analysis Set On-treatment period.~The HR, two-sided CI, and p-value for pairwise comparisons versus Warfarin are based on the Cox regression model with counting process approach for on-treatment including treatment and the two stratification factors as covariates: the dichotomized CHADS2 score and the dichotomized dose-adjustment factor"||.548|.406|<.0001
70898462|NCT00781391|141284544|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86|||<|0.0001|TWO_SIDED|95.0|0.8|0.918|||Regression, Cox|||Major or Clinically Relevant Non-Major, high dose vs. warfarin||.918|.800|<.0001
70898463|NCT00781391|141284544|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.62|||<|0.0001|TWO_SIDED|95.0|0.575|0.666|||Regression, Cox|||Major or Clinically Relevant Non-Major, low dose vs. warfarin||.666|.575|<.0001
70898464|NCT00420992|141284621|SUPERIORITY_OR_OTHER|||||||0.0445||95.0||||Threshold for statistical significance: P=0.05. No adjustment for multiple comparisons necessary.|ANCOVA|Model included treatment as factor and baseline pain score as covariate.||Null hypothesis: mean change from baseline is the same for ALO-01 and placebo.||||0.0445
70898465|NCT01058304|141284639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.67||||0.1024|TWO_SIDED|95.0|-5.87|0.538|||Mixed Models Analysis|||"The analysis compares study Arm 1 and Arm 2 at 24-week follow-up, with 12-week data also included in the response trajectory.~The hypothesis being tested is that group-based PT (Arm 1) will result in a significantly greater improvement WOMAC scores compared to individual PT (Arm 2)"||0.538|-5.87|0.1024
70898466|NCT01058304|141284639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.444|TWO_SIDED|95.0|-4.64|2.04|||Mixed Models Analysis|||The hypothesis being tested is that the group-based PT program (Arm 1) will result in greater improvements in WOMAC scores at 24-week follow-up (12 weeks after the end of the group program) when compared to usual PT care (Arm 2).||2.04|-4.64|0.444
70898467|NCT01058304|141284640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.113||||0.527|TWO_SIDED|95.0|-0.463|0.238|||Mixed Models Analysis|||The analysis compares Arms 1 and 2 at 12-week follow-up. The hypothesis being tested is that the group-based PT program (Arm 1) will result in a significantly greater improvement in SPPB scores compared with the individual PT program (Arm 2).||0.238|-0.463|0.527
70898468|NCT00762450|141284661|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|paired t-tests||The null hypothesis states that there is no difference between groups.||||0.05
70898469|NCT03905330|141284662|SUPERIORITY||Least-Square mean|-1.089|STANDARD_ERROR_OF_MEAN|0.3691|=|0.0063|TWO_SIDED|95.0|-1.845|-0.334|||Mixed Models Analysis|||The difference between maralixibat and placebo treatment groups in the mean change in the average ItchRO(Obs) severity score between baseline and Weeks 15-26||-0.334|-1.845|= 0.0063
70898470|NCT03905330|141284663|SUPERIORITY||Least-Square mean|-186.723|STANDARD_ERROR_OF_MEAN|51.9501|=|0.0013|TWO_SIDED|95.0|-293.454|-79.992|||Mixed Models Analysis|||||-79.992|-293.454|= 0.0013
70898471|NCT03905330|141284664|SUPERIORITY||Least-Square mean|-1.2|STANDARD_ERROR_OF_MEAN|0.263|<|0.0001|TWO_SIDED|95.0|-1.727|-0.674|||Mixed Models Analysis|||||-0.674|-1.727|< 0.0001
70898472|NCT03905330|141284665|SUPERIORITY||Least-Square mean|-160.403|STANDARD_ERROR_OF_MEAN|30.1827|<|0.0001|TWO_SIDED|95.0|-220.836|-99.97|||Mixed Models Analysis|||||-99.970|-220.836|< 0.0001
70898473|NCT03905330|141284666|OTHER||||||=|0.0736|||||||Bernard's exact test|||||||= 0.0736
70898474|NCT03905330|141284667|SUPERIORITY||||||=|0.041|||||||Bernard's exact test|||||||= 0.0410
70898475|NCT03905330|141284668|SUPERIORITY||||||=|0.0023|||||||Bernard's exact test|||||||= 0.0023
70898476|NCT03905330|141284669|SUPERIORITY||||||=|0.0004|||||||Bernard's exact test|||||||= 0.0004
70898477|NCT01939548|141284679|SUPERIORITY_OR_OTHER||Least Squares Mean (LSM) Difference|3.11|STANDARD_ERROR_OF_MEAN|2.409||0.1991|TWO_SIDED|80.0|0.01|6.21||Primary analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), PANSS Total baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value of PANSS Total by treatment interaction and background antipsychotics.||6.21|0.01|0.1991
70898478|NCT01939548|141284679|SUPERIORITY_OR_OTHER||LSM Difference|2.3|STANDARD_ERROR_OF_MEAN|2.445||0.3488|TWO_SIDED|80.0|-0.85|5.45||Primary analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), PANSS Total baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value of PANSS Total by treatment interaction and background antipsychotics.||5.45|-0.85|0.3488
70898479|NCT01939548|141284680|SUPERIORITY_OR_OTHER||LSM Difference|-0.23|STANDARD_ERROR_OF_MEAN|1.476||0.8786|TWO_SIDED|80.0|-2.13|1.67||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Analysis of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.67|-2.13|0.8786
70898480|NCT01939548|141284680|SUPERIORITY_OR_OTHER||LSM Difference|-1.14|STANDARD_ERROR_OF_MEAN|1.502||0.4483|TWO_SIDED|80.0|-3.08|0.79||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Analysis of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.79|-3.08|0.4483
70898481|NCT01939548|141284681|SUPERIORITY_OR_OTHER||LSM Difference|0.81|STANDARD_ERROR_OF_MEAN|0.809||0.3201|TWO_SIDED|80.0|-0.23|1.85||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Positive Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.85|-0.23|0.3201
70898482|NCT01939548|141284681|SUPERIORITY_OR_OTHER||LSM Difference|0.85|STANDARD_ERROR_OF_MEAN|0.813||0.2961|TWO_SIDED|80.0|-0.19|1.9||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Positive Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.90|-0.19|0.2961
70898483|NCT01939548|141284681|SUPERIORITY_OR_OTHER||LSM Difference|0.39|STANDARD_ERROR_OF_MEAN|0.743||0.6015|TWO_SIDED|80.0|-0.57|1.35||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Negative Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.35|-0.57|0.6015
70898484|NCT01939548|141284681|SUPERIORITY_OR_OTHER||LSM Difference|0.21|STANDARD_ERROR_OF_MEAN|0.761||0.7787|TWO_SIDED|80.0|-0.77|1.19||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Negative Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.19|-0.77|0.7787
70898485|NCT01939548|141284681|SUPERIORITY_OR_OTHER||LSM Difference|1.63|STANDARD_ERROR_OF_MEAN|1.285||0.2068|TWO_SIDED|80.0|-0.02|3.29||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|General Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||3.29|-0.02|0.2068
70898486|NCT01939548|141284681|SUPERIORITY_OR_OTHER||LSM Difference|0.98|STANDARD_ERROR_OF_MEAN|1.326||0.4611|TWO_SIDED|80.0|-0.73|2.69||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|General Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||2.69|-0.73|0.4611
70898487|NCT01939548|141284682|SUPERIORITY_OR_OTHER||LSM Difference|0.96|STANDARD_ERROR_OF_MEAN|0.591||0.1083|TWO_SIDED|80.0|0.19|1.72||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Anxiety/depression symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.72|0.19|0.1083
70898488|NCT01939548|141284682|SUPERIORITY_OR_OTHER||LSM Difference|1.05|STANDARD_ERROR_OF_MEAN|0.611||0.0869|TWO_SIDED|80.0|0.27|1.84||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Anxiety/depression symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.84|0.27|0.0869
70898489|NCT01939548|141284682|SUPERIORITY_OR_OTHER||LSM Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.575||0.8601|TWO_SIDED|80.0|-0.84|0.64||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Disorganized thought symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.64|-0.84|0.8601
70898490|NCT01939548|141284682|SUPERIORITY_OR_OTHER||LSM Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.593||0.3454|TWO_SIDED|80.0|-1.33|0.2||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Disorganized thought symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.20|-1.33|0.3454
70898491|NCT01939548|141284682|SUPERIORITY_OR_OTHER||LSM Difference|0.78|STANDARD_ERROR_OF_MEAN|0.789||0.3273|TWO_SIDED|80.0|-0.24|1.79||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Negative symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.79|-0.24|0.3273
70898492|NCT01939548|141284682|SUPERIORITY_OR_OTHER||LSM Difference|0.69|STANDARD_ERROR_OF_MEAN|0.806||0.3963|TWO_SIDED|80.0|-0.35|1.72||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Negative symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.72|-0.35|0.3963
70898493|NCT01939548|141284682|SUPERIORITY_OR_OTHER||LSM Difference|0.64|STANDARD_ERROR_OF_MEAN|0.888||0.4713|TWO_SIDED|80.0|-0.5|1.78||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Positive symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.78|-0.50|0.4713
70898494|NCT01939548|141284682|SUPERIORITY_OR_OTHER||LSM Difference|1.21|STANDARD_ERROR_OF_MEAN|0.895||0.1787|TWO_SIDED|80.0|0.06|2.36||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Positive symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||2.36|0.06|0.1787
70898495|NCT01939548|141284682|SUPERIORITY_OR_OTHER||LSM Difference|0.35|STANDARD_ERROR_OF_MEAN|0.426||0.4123|TWO_SIDED|80.0|-0.2|0.9||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Uncontrolled hostility/excitement symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.90|-0.20|0.4123
70898496|NCT01939548|141284682|SUPERIORITY_OR_OTHER||LSM Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.441||0.3202|TWO_SIDED|80.0|-1.01|0.13||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Uncontrolled hostility/excitement symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.13|-1.01|0.3202
70898497|NCT01939548|141284683|SUPERIORITY_OR_OTHER||LSM Difference|0.04|STANDARD_ERROR_OF_MEAN|0.119||0.7399|TWO_SIDED|80.0|-0.11|0.19||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Analysis of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.19|-0.11|0.7399
70898498|NCT01939548|141284683|SUPERIORITY_OR_OTHER||LSM Difference|0.13|STANDARD_ERROR_OF_MEAN|0.122||0.2747|TWO_SIDED|80.0|-0.02|0.29||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Analysis of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.29|-0.02|0.2747
70898499|NCT01939548|141284684|SUPERIORITY_OR_OTHER||LSM Difference|0.07|STANDARD_ERROR_OF_MEAN|0.188||0.7219|TWO_SIDED|80.0|-0.17|0.31||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|ANOVA|||Analysis of change at Week 12. Mixed effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site, visit and visit-by-treatment interaction; random effect: participant.||0.31|-0.17|0.7219
70898500|NCT01939548|141284684|SUPERIORITY_OR_OTHER||LSM Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.192||0.9315|TWO_SIDED|80.0|-0.26|0.23||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|ANOVA|||Analysis of change at Week 12. Mixed effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site, visit and visit-by-treatment interaction; random effect: participant.||0.23|-0.26|0.9315
70898501|NCT02276222|141284782|SUPERIORITY||Least Squares Mean (SE)|0.0084|STANDARD_ERROR_OF_MEAN|0.01012||0.4041|TWO_SIDED|95.0|-0.0114|0.0283|||ANCOVA|||||0.0283|-0.0114|0.4041
70898502|NCT02170025|141284789|OTHER||Bayesian analysis|-1.3|||||TWO_SIDED|90.0|-8.7|6.0||||||Treatment effect describes the difference in outcomes between 0.5 mg riociguat and placebo on Day 14. This was an exploratory analysis. For sample size determination a probabilistic assessment on predicted point estimates and width of credible intervals was performed.||6.0|-8.7|
70898503|NCT02170025|141284789|OTHER||Bayesian analysis|-5.0|||||TWO_SIDED|90.0|-12.4|2.4||||||Treatment effect describes the difference in outcomes between 1.0 mg riociguat and placebo on Day 28. This was an exploratory analysis. For sample size determination a probabilistic assessment on predicted point estimates and width of credible intervals was performed.||2.4|-12.4|
70898504|NCT00572195|141284791|OTHER||Wilson score interval|77.0|||||TWO_SIDED|95.0|71.1|81.9|||||The value is for all serious adverse events, regardless of device relation.||95% confidence interval estimated using the Wilson score interval|81.9|71.1|
70898505|NCT00572195|141284792|OTHER||||||<|0.05||||||For all 6-month periods, from 6 months through 9 years post-implant, p \<0.05.|Wilcoxon Signed Rank Test|||||||<0.05
70898506|NCT00572195|141284794|OTHER||GEE estimated intercept|48.0|||<|0.0001|TWO_SIDED|95.0|46.8|49.2|||Generalized estimating equation (GEE)|||||49.2|46.8|<0.0001
70898507|NCT00572195|141284794|OTHER||Slope|0.0||||0.6729|TWO_SIDED|95.0|-0.2|0.1|||Generalized estimating equation (GEE)|||||0.1|-0.2|0.6729
70898508|NCT00902694|141284796|SUPERIORITY||Mean Difference (Net)|-1.5|||||TWO_SIDED|95.0|-2.6|-0.4||||||6 month intervention versus control||-0.4|-2.6|
70898509|NCT00902694|141284796|SUPERIORITY||Mean Difference (Net)|-3.2|||||TWO_SIDED|95.0|-5.1|-1.2||||||18 month intervention versus control||-1.2|-5.1|
70898510|NCT00902694|141284798|SUPERIORITY||Mean Difference (Net)|-2.0|||||TWO_SIDED|95.0|-3.6|-0.4||||||6 month intervention versus control||-0.4|-3.6|
70898511|NCT00902694|141284798|SUPERIORITY||Mean Difference (Net)|-1.9|||||TWO_SIDED|95.0|-4.1|0.3||||||18 month intervention versus control||0.3|-4.1|
70898512|NCT00902694|141284799|SUPERIORITY||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-3.2|2.4||||||6 month systolic intervention versus control||2.4|-3.2|
70898513|NCT00902694|141284799|SUPERIORITY||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-1.6|2.1||||||6 month diastolic intervention versus control||2.1|-1.6|
70898514|NCT00902694|141284799|SUPERIORITY||Mean Difference (Net)|1.6|||||TWO_SIDED|95.0|-1.6|4.8||||||18 month systolic intervention versus control||4.8|-1.6|
70898515|NCT00902694|141284799|SUPERIORITY||Mean Difference (Net)|1.2|||||TWO_SIDED|95.0|-0.9|3.4||||||18 month diastolic intervention versus control||3.4|-0.9|
70898516|NCT00902694|141284800|SUPERIORITY||Mean Difference (Net)|-2.9|||||TWO_SIDED|95.0|-9.9|4.1||||||6 month total chol intervention versus control||4.1|-9.9|
70898517|NCT00902694|141284800|SUPERIORITY||Mean Difference (Net)|-5.2|||||TWO_SIDED|95.0|-14.9|4.4||||||18 month total chol intervention versus control||4.4|-14.9|
70898518|NCT00902694|141284800|SUPERIORITY||Mean Difference (Net)|-1.2|||||TWO_SIDED|95.0|-7.5|5.1||||||6 month LDL chol intervention versus control||5.1|-7.5|
70898519|NCT00902694|141284800|SUPERIORITY||Mean Difference (Net)|-4.6|||||TWO_SIDED|95.0|-13.1|3.9||||||18 month LDL chol intervention versus control||3.9|-13.1|
70898520|NCT00902694|141284800|SUPERIORITY||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-2.9|1.7||||||6 month HDL chol intervention versus control||1.7|-2.9|
70898521|NCT00902694|141284800|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|95.0|-1.8|3.1||||||18 month HDL intervention versus control||3.1|-1.8|
70898522|NCT00902694|141284800|SUPERIORITY||Mean Difference (Net)|-5.5|||||TWO_SIDED|95.0|-23.5|12.4||||||6 month TRIG intervention versus control||12.4|-23.5|
70898523|NCT00902694|141284800|SUPERIORITY||Mean Difference (Net)|-1.5|||||TWO_SIDED|95.0|-27.0|23.9||||||18 month TRIG intervention versus control||23.9|-27.0|
70898524|NCT01024608|141284812|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo|-0.91|||<|0.001|TWO_SIDED|95.0|-1.3|-0.5||A priori threshold for statistical significance is p\<0.05.|ANCOVA|Repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.5|-1.3|<0.001
70898525|NCT01024608|141284813|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo|-0.92|||<|0.001|TWO_SIDED|95.0|-1.3|-0.5||A priori threshold for statistical significance is p\<0.05|ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.5|-1.3|<0.001
70898526|NCT01024608|141284814|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo|-0.48||||0.005|TWO_SIDED|95.0|-0.8|-0.1||A priori threshold for statistical significance is p\<0.05|ANCOVA|Results obtained from ANCOVA with treatment, baseline and center in the model.||||-0.1|-0.8|0.005
70898527|NCT01024608|141284815|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo|-0.56||||0.002|TWO_SIDED|95.0|-0.9|-0.2||A priori threshold for statistical significance is p\<0.05|ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction||||-0.2|-0.9|0.002
70898528|NCT04922554|141284842|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Difference in response rates|14.15||||0.2182|TWO_SIDED|||||Nominal p-values are provided for descriptive purposes.|Chi-squared|Analysis stratified by prior NTM antibiotic treatment was not performed due to small sample size in one randomization stratification subgroup.||||||0.2182
70898529|NCT04922554|141284843|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Difference in response rates|22.15||||0.046|TWO_SIDED|||||Nominal p-values are provided for descriptive purposes.|Chi-squared|Analysis stratified by prior NTM antibiotic treatment was not performed due to small sample size in one randomization stratification subgroup.||||||0.0460
70898530|NCT04922554|141284852|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|0.8||||0.824|TWO_SIDED|95.0|-6.01|7.52||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||7.52|-6.01|0.8240
70898531|NCT04922554|141284853|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|5.1||||0.2149|TWO_SIDED|95.0|-3.03|13.2||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||13.20|-3.03|0.2149
70898532|NCT04922554|141284854|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|8.3||||0.123|TWO_SIDED|95.0|-2.31|18.88||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||18.88|-2.31|0.1230
70898533|NCT04922554|141284855|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|5.5||||0.1168|TWO_SIDED|95.0|-1.41|12.43||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||12.43|-1.41|0.1168
70898534|NCT04922554|141284856|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|6.5||||0.0743|TWO_SIDED|95.0|-0.66|13.66||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||13.66|-0.66|0.0743
70898535|NCT04922554|141284857|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|7.1||||0.0899|TWO_SIDED|95.0|-1.13|15.23||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||15.23|-1.13|0.0899
70898536|NCT04922554|141284858|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|0.5||||0.9019|TWO_SIDED|95.0|-7.6|8.59||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||8.59|-7.60|0.9019
70898537|NCT04922554|141284859|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|13.7||||0.0015|TWO_SIDED|95.0|5.43|21.89||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||21.89|5.43|0.0015
70898538|NCT04922554|141284860|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|0.9||||0.8269|TWO_SIDED|95.0|-7.26|9.05||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA||Treatment comparison of Omadacycline and Placebo for activity score has been presented.|||9.05|-7.26|0.8269
70898539|NCT04922554|141284860|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|-0.2||||0.9584|TWO_SIDED|95.0|-7.74|7.35||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA||Treatment comparison between Omadacycline and Placebo for impact score has been presented|||7.35|-7.74|0.9584
70898540|NCT04922554|141284860|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|-5.0||||0.2123|TWO_SIDED|95.0|-12.88|2.92||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA||Treatment comparison between Omadacycline and Placebo for symptom score has been presented.|||2.92|-12.88|0.2123
70898541|NCT04922554|141284860|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|-0.8||||0.8161|TWO_SIDED|95.0|-7.58|5.99||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA||Treatment comparison between Omadacycline and Placebo for total score has been presented.|||5.99|-7.58|0.8161
70898542|NCT04922554|141284861|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|-5.7||||0.001|TWO_SIDED|95.0|-8.95|-2.38||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||-2.38|-8.95|0.0010
70898543|NCT04922554|141284862|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Difference in improvement rates|39.61||||0.002|TWO_SIDED|95.0|16.66|62.56|||Fisher Exact|||||62.56|16.66|0.0020
70898544|NCT04922554|141284863|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Difference in improvement rates|15.41||||0.3051|TWO_SIDED|95.0|-9.1|39.93|||Fisher Exact|||||39.93|-9.10|0.3051
70898545|NCT04922554|141284864|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.||||||0.3552|||||||Wilcoxon rank sum test|||||||0.3552
70898546|NCT04922554|141284865|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.||||||0.0753|||||||Wilcoxon rank sum test|||||||0.0753
70898547|NCT04922554|141284867|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Odds Ratio (OR)|3.84||||0.0168|TWO_SIDED|95.0|1.24|11.87|||Chi-squared|||||11.87|1.24|0.0168
70898548|NCT04922554|141284868|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.||||||0.0233|||||||Log Rank|||||||0.0233
70898549|NCT04922554|141284869|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.||||||0.0349|||||||Log Rank|||||||0.0349
70898550|NCT04676425|141284870|OTHER||Least-Squares Geometric Mean Ratio|1.19|||||TWO_SIDED|90.0|0.7|2.01|||||Moderate hepatic impairment participants represent the numerator and healthy participants represent the denominator in the geometric mean ratio.|||2.01|0.70|
70898551|NCT04676425|141284871|OTHER||Least-Squares Geometric Mean Ratio|1.22|||||TWO_SIDED|90.0|0.86|1.74|||||Moderate hepatic impairment participants represent the numerator and healthy participants represent the denominator in the geometric mean ratio.|||1.74|0.86|
70898552|NCT00990964|141284882|SUPERIORITY_OR_OTHER||One sample proportion|0.94|||||TWO_SIDED|95.0|0.929|0.951||||||||.951|.929|
70898553|NCT00990964|141284883|SUPERIORITY_OR_OTHER||One sample proportion|0.974|||||TWO_SIDED|95.0|0.965|0.98||||||||.980|.965|
70898554|NCT00514943|141284891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.49||||0.7606|TWO_SIDED|95.0|-11.188|8.202||P-value obtained from fitting an ANCOVA model including treatment, stratification factor prior chemotherapy for recurrent/metastatic disease and the baseline sum of longest distance of target lesions.|ANCOVA|Receipt of prior chemotherapy for recurrent/metastatic disease and the baseline sum of longest distance for target lesions are covariates|Mean difference calculated is actually the adjusted mean difference.|||8.202|-11.188|0.7606
70898555|NCT00514943|141284904|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.942||||0.764|TWO_SIDED|95.0|0.64|1.387|||Regression, Cox||Hazard ratio, 95% CI and p-value are calculated from the Cox proportional hazards model stratified by the number of prior chemotherapies for R/M setting (0 or \>=1)|||1.387|0.640|0.764
70898556|NCT00514943|141284905|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.725||||0.219|TWO_SIDED|95.0|0.434|1.212|||Regression, Cox||Hazard ratio, 95% CI and p-value are calculated from the Cox proportional hazards model stratified by the number of prior chemotherapies for R/M setting (0 or \>=1)|||1.212|0.434|0.219
70898557|NCT00514943|141284906|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.067||||0.758|TWO_SIDED|95.0|0.708|1.608|||Regression, Cox||Hazard ratio, 95% CI and p-value are calculated from the Cox proportional hazards model stratified by the number of prior chemotherapies for R/M setting (0 or \>=1)|||1.608|0.708|0.758
70898558|NCT02066402|141284978|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority (NI) hypothesis test is a 1-sided hypothesis test performed at the 2.5% level of significance. Predefined margin for non-inferiority is -10%.|Difference of responder rate|-4.6||||0.2027|TWO_SIDED|95.0|-11.2|2.2|||Fisher Exact|||||2.2|-11.2|0.2027
70898559|NCT02066402|141284979|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority (NI) hypothesis test is a 1-sided hypothesis test performed at the 2.5% level of significance.|Difference of responder rate|-2.2|||||TWO_SIDED|95.0|-8.3|3.8||||||||3.8|-8.3|
70898560|NCT02066402|141284980|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority (NI) hypothesis test is a 1-sided hypothesis test performed at the 2.5% level of significance.|Difference of responder rate|-2.1|||||TWO_SIDED|95.0|-7.4|3.2||||||||3.2|-7.4|
70898561|NCT02066402|141284981|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority (NI) hypothesis test is a 1-sided hypothesis test performed at the 2.5% level of significance.|Difference of responder rate|-2.2|||||TWO_SIDED|95.0|-8.6|4.1||||||||4.1|-8.6|
70898562|NCT02066402|141284982|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority (NI) hypothesis test is a 1-sided hypothesis test performed at the 2.5% level of significance.|Difference of responder rate|-3.1|||||TWO_SIDED|95.0|-8.4|2.0||||||||2.0|-8.4|
70898563|NCT04493931|141284989|OTHER||Ratio of Geometric LS Mean|0.944|||||TWO_SIDED|90.0|0.753|1.184||||||||1.184|0.753|
70898564|NCT04493931|141284990|OTHER||Median Difference (Final Values)|-0.25|||||TWO_SIDED|90.0|-0.75|0.742|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.742|-0.750|
70898565|NCT04493931|141284991|OTHER||Ratio of Geometric LS Mean|1.094|||||TWO_SIDED|90.0|0.959|1.249||||||||1.249|0.959|
70898566|NCT04493931|141284992|OTHER||Ratio of Geometric LS Mean|1.157|||||TWO_SIDED|90.0|1.059|1.265||||||||1.265|1.059|
70898567|NCT04493931|141284993|OTHER||Ratio of Geometric LS Mean|1.158|||||TWO_SIDED|90.0|1.062|1.264||||||||1.264|1.062|
70898568|NCT04493931|141284994|OTHER||Ratio of Geometric LS Mean|0.73|||||TWO_SIDED|90.0|0.635|0.84||||||||0.840|0.635|
70898569|NCT04493931|141284995|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.000|0.000|
70898570|NCT04493931|141284996|OTHER||Median Difference (Final Values)|-0.467|||||TWO_SIDED|90.0|-1.0|0.492|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate|||0.492|-1.000|
70898571|NCT04493931|141284997|OTHER||Ratio of Geometric LS Mean|0.476|||||TWO_SIDED|90.0|0.433|0.525||||||||0.525|0.433|
70898572|NCT04493931|141284998|OTHER||Ratio of Geometric LS Mean|0.478|||||TWO_SIDED|90.0|0.435|0.526||||||||0.526|0.435|
70898573|NCT04493931|141284999|OTHER||Ratio of Geometric LS mean|1.533|||||TWO_SIDED|90.0|1.274|1.845||||||||1.845|1.274|
70898574|NCT04493931|141285000|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.000|0.000|
70898575|NCT04493931|141285001|OTHER||Median Difference (Final Values)|-0.5|||||TWO_SIDED|90.0|-1.0|-0.233|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||-0.233|-1.000|
70898576|NCT04493931|141285002|OTHER||Ratio of Geometric LS mean|1.217|||||TWO_SIDED|90.0|1.085|1.363||||||||1.363|1.085|
70898577|NCT04493931|141285003|OTHER||Ratio of Geometric LS mean|1.121|||||TWO_SIDED|90.0|0.983|1.278||||||||1.278|0.983|
70898578|NCT04493931|141285004|OTHER||Ratio of Geometric LS mean|1.242|||||TWO_SIDED|90.0|1.046|1.475||||||||1.475|1.046|
70898579|NCT04493931|141285005|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.000|0.000|
70898580|NCT04493931|141285006|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|-0.25|0.8|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.800|-0.250|
70898581|NCT04493931|141285007|OTHER||Ratio of Geometric LS mean|1.923|||||TWO_SIDED|90.0|1.622|2.278||||||||2.278|1.622|
70898582|NCT04493931|141285008|OTHER||Ratio of Geometric LS mean|1.902|||||TWO_SIDED|90.0|1.619|2.234||||||||2.234|1.619|
70898583|NCT04493931|141285032|OTHER||Ratio of geometric LS mean|1.051|||||TWO_SIDED|90.0|0.824|1.34||||||||1.340|0.824|
70898584|NCT04493931|141285033|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.25|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.250|0.000|
70898585|NCT04493931|141285034|OTHER||Median Difference (Final Values)|0.5|||||TWO_SIDED|90.0|-0.5|1.25|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||1.250|-0.500|
70898586|NCT04493931|141285035|OTHER||Ratio of geometric LS mean|1.094|||||TWO_SIDED|90.0|0.987|1.212||||||||1.212|0.987|
70898587|NCT04493931|141285036|OTHER||Ratio of geometric LS mean|1.095|||||TWO_SIDED|90.0|0.991|1.209||||||||1.209|0.991|
70898588|NCT04493931|141285039|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|-0.25|0.0|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.000|-0.250|
70898589|NCT04493931|141285042|OTHER||Ratio of geometric LS mean|1.214|||||TWO_SIDED|90.0|1.0|1.473||||||||1.473|1.000|
70898590|NCT04493931|141285043|OTHER||Ratio of geometric LS mean|1.097|||||TWO_SIDED|90.0|0.948|1.27||||||||1.270|0.948|
70898591|NCT04493931|141285044|OTHER||Ratio of geometric LS mean|1.071|||||TWO_SIDED|90.0|0.939|1.221||||||||1.221|0.939|
70898592|NCT04493931|141285045|OTHER||Ratio of geometric LS mean|1.096|||||TWO_SIDED|90.0|0.93|1.292||||||||1.292|0.930|
70898593|NCT04493931|141285059|OTHER||Ratio of geometric LS mean|0.499|||||TWO_SIDED|90.0|0.441|0.565||||||||0.565|0.441|
70898594|NCT04493931|141285060|OTHER||Ratio of geometric LS mean|0.439|||||TWO_SIDED|90.0|0.37|0.521||||||||0.521|0.370|
70898595|NCT04493931|141285061|OTHER||Ratio of geometric LS mean|0.438|||||TWO_SIDED|90.0|0.372|0.516||||||||0.516|0.372|
70898596|NCT04493931|141285062|OTHER||Ratio of geometric LS mean|1.036|||||TWO_SIDED|90.0|0.95|1.129||||||||1.129|0.950|
70898597|NCT04493931|141285086|OTHER||Ratio of Geometric LS mean|1.755|||||TWO_SIDED|90.0|1.304|2.363||||||||2.363|1.304|
70898598|NCT04493931|141285087|OTHER||Ratio of Geometric LS mean|0.833|||||TWO_SIDED|90.0|0.769|0.902||||||||0.902|0.769|
70898599|NCT04493931|141285088|OTHER||Ratio of Geometric LS mean|0.745|||||TWO_SIDED|90.0|0.653|0.85||||||||0.850|0.653|
70898600|NCT04493931|141285089|OTHER||Ratio of Geometric LS mean|0.892|||||TWO_SIDED|90.0|0.782|1.018||||||||1.018|0.782|
70898601|NCT04493931|141285090|OTHER||Ratio of Geometric LS mean|1.157|||||TWO_SIDED|90.0|0.876|1.528||||||||1.528|0.876|
70898602|NCT04493931|141285091|OTHER||Ratio of Geometric LS mean|1.142|||||TWO_SIDED|90.0|1.016|1.283||||||||1.283|1.016|
70898603|NCT04493931|141285092|OTHER||Ratio of Geometric LS mean|0.603|||||TWO_SIDED|90.0|0.521|0.699||||||||0.699|0.521|
70898604|NCT04493931|141285093|OTHER||Ratio of Geometric LS mean|0.526|||||TWO_SIDED|90.0|0.448|0.618||||||||0.618|0.448|
70898605|NCT02182973|141285167|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
70898606|NCT02182973|141285168|SUPERIORITY|||||||0.875|||||||t-test, 2 sided|||||||0.875
70898607|NCT02182973|141285169|SUPERIORITY|||||||0.025|||||||t-test, 2 sided|||||||0.025
70898608|NCT01123382|141285180|SUPERIORITY_OR_OTHER|||||||0.04||||||Group X time interaction|Mixed Models Analysis|we included a random intercept for each individual participant. We used a first-order antedependent covariance structure.||To detect a minimum clinically important difference of 2 points2 on the BPI-SF3 with an anticipated standard deviation for each mean of 2.5, estimated from a prior study, with an alpha level of 0.05 and a power of 80%, for five waves of data, a sample size of 10 participants per group was necessary. With anticipated dropouts, a sample size of at least 12 participants per group was required.||||0.04
70898609|NCT01123382|141285181|SUPERIORITY_OR_OTHER|||||||0.059|TWO_SIDED|||||group x time interaction 0.059|Mixed Models Analysis|||||||0.059
70898610|NCT01123382|141285182|SUPERIORITY_OR_OTHER|||||||0.543||||||group x time interaction 0.543|Mixed Models Analysis|||||||0.543
70898611|NCT01123382|141285183|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED|||||group x time interaction 0.33|Mixed Models Analysis|||||||0.33
70898612|NCT01123382|141285184|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED|||||group x time 0.61|Mixed Models Analysis|||||||0.61
70898613|NCT01123382|141285185|SUPERIORITY_OR_OTHER|||||||0.398||||||group x time interaction 0.398|Mixed Models Analysis|||||||0.398
70898614|NCT01123382|141285186|SUPERIORITY_OR_OTHER|||||||0.46||||||group x time interaction 0.46|Mixed Models Analysis|||||||0.46
70898615|NCT01123382|141285187|SUPERIORITY_OR_OTHER|||||||0.59||||||group x time interaction 0.59|Mixed Models Analysis|||||||0.59
70898616|NCT01123382|141285188|SUPERIORITY_OR_OTHER|||||||0.69||||||group x time interaction 0.69|Mixed Models Analysis|||||||0.69
70898617|NCT01755702|141285216|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.284|TWO_SIDED|95.0|0.83|1.9|||Cox Proportional Hazard Model|||Null hypothesis considered no difference between the treatments in comparison.||1.90|0.83|0.2840
70898618|NCT01755702|141285216|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.2008|TWO_SIDED|95.0|0.86|2.01|||Cox Proportional Hazard Model|||Null hypothesis considered no difference between the treatments in comparison.||2.01|0.86|0.2008
70898619|NCT01755702|141285216|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.4552|TWO_SIDED|95.0|0.78|1.74|||Cox Proportional Hazard Model|||Null hypothesis considered no difference between the treatments in comparison.||1.74|0.78|0.4552
70898620|NCT01755702|141285216|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.5579|TWO_SIDED|95.0|0.75|1.71|||Cox Proportional Hazard Model|||||1.71|0.75|0.5579
70898621|NCT01755702|141285216|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.7214|TWO_SIDED|95.0|0.72|1.61|||Cox Proportional Hazard Model|||Null hypothesis considered no difference between the treatments in comparison.||1.61|0.72|0.7214
70898622|NCT01755702|141285216|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.8192|TWO_SIDED|95.0|0.62|1.45|||Cox Proportional Hazard Model|||Null hypothesis considered no difference between the treatments in comparison.||1.45|0.62|0.8192
70898623|NCT02755597|141285247|SUPERIORITY||Hazard Ratio (HR)|0.656|||=|0.012|TWO_SIDED|95.0|0.471|0.913|||Log Rank||Hazard ratio was estimated by Cox proportional hazards model|Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||0.913|0.471|=0.012
70898624|NCT02755597|141285248|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||||<0.001
70898625|NCT02755597|141285250|SUPERIORITY||Hazard Ratio (HR)|0.508|||<|0.001|TWO_SIDED|95.0|0.343|0.753|||Log Rank||Hazard ratio was estimated by Cox proportional hazards model|Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||0.753|0.343|<0.001
70898626|NCT02755597|141285255|SUPERIORITY||Hazard Ratio (HR)|1.191|||=|0.385|TWO_SIDED|95.0|0.802|1.77|||Log Rank||Hazard ratio was estimated by Cox proportional hazards model|Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||1.770|0.802|=0.385
70898627|NCT02755597|141285256|SUPERIORITY||Hazard Ratio (HR)|0.571|||=|0.001|TWO_SIDED|95.0|0.405|0.805|||Log Rank||Hazard ratio was estimated by Cox proportional hazards model|Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||0.805|0.405|=0.001
70898628|NCT02755597|141285257|SUPERIORITY||||||=|0.019|||||||Cochran-Mantel-Haenszel|||Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||||=0.019
70898629|NCT02755597|141285258|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||||<0.001
70898630|NCT01069354|141285259|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.41|||<|0.0001|TWO_SIDED|||||Paired t-test|t-test, 2 sided|||||||<0.0001
70898631|NCT01069354|141285260|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Binomial proportion, two-sided Fisher's exact test|Fisher Exact|||91 (90.1%) of 101 subjects had a ≥ 2.0 cm lower VAS Score in treatment versus control NLF at Time 0||||<0.0001
70898632|NCT01069354|141285261|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Paired t-test|t-test, 2 sided|||||||<0.0001
70898633|NCT01069354|141285262|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Paired t-test|t-test, 2 sided|||||||<0.0001
70898634|NCT01069354|141285263|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Paired t-test|t-test, 2 sided|||||||<0.0001
70898635|NCT01069354|141285264|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Paired t-test|t-test, 2 sided|||||||<0.0001
70898636|NCT01069354|141285265|SUPERIORITY_OR_OTHER|||||||0.5663||||||Paired t-test|t-test, 2 sided|||||||0.5663
70898637|NCT01069354|141285266|SUPERIORITY_OR_OTHER|||||||0.3197||||||Paired t-test|t-test, 2 sided|||||||0.3197
70898638|NCT02684006|141285272|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.0001|TWO_SIDED|95.0|0.475|0.79||2-sided p-value|Log Rank|||||0.790|0.475|0.0001
70898639|NCT02684006|141285273|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.1509|TWO_SIDED|95.0|0.701|1.057||2-sided p-value|Log Rank|||||1.057|0.701|0.1509
70898640|NCT02684006|141285274|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0002|TWO_SIDED|95.0|0.563|0.84||2-sided p-value|Log Rank|||||0.840|0.563|0.0002
70898641|NCT02684006|141285275|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1338|TWO_SIDED|95.0|0.749|1.039||2-sided p-value|Log Rank|||||1.039|0.749|0.1338
70898642|NCT02684006|141285284|SUPERIORITY||Hazard Ratio (HR)|0.66|||<|0.0001|TWO_SIDED|95.0|0.565|0.768||2-sided p-value|Log Rank|||||0.768|0.565|<.0001
70898643|NCT02684006|141285285|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.551|0.754||||||||0.754|0.551|
70898644|NCT02413580|141285306|OTHER|The hypothesis test is to test the null hypothesis: H0: μd = 0 versus alternative hypothesis Ha: μd ≠ 0 where μd is the mean change from Baseline to Day 14. The Shapiro-Wilk test is used to test the normality. If the assumptions for parametric test are met, a paired t-test (comparison between the pre- and post-treatment) is used to test for the treatment effect. Otherwise, a non-parametric test (Wilcoxon signed rank test) is used.|Mean Difference (Final Values)|-6.4|||<|0.001|TWO_SIDED|95.0|-7.957|-4.787|||Paired t-test|||||-4.787|-7.957|<0.001
70898645|NCT04274894|141285350|NON_INFERIORITY|"The hypothesis for the primary safety analysis is:~H0: Change in 24-hour average SBP from Baseline to EOT ≥ 3 mmHg Vs. H1: Change in 24-hour average SBP from Baseline to EOT \< 3 mmHg"|LS Mean Change from Baseline to EOT|1.9|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|0.63|3.13||||||The primary endpoint of change from Baseline to End of Treatment (EOT) in average 24-hour SBP was evaluated using a linear regression model with change in average 24-hour SBP from Baseline to EOT as the dependent variable, centralized baseline average 24-hour SBP, ongoing medical history of hypertension, and pooled study center as covariates in the per protocol population.||3.13|0.63|
70898646|NCT02279043|141285351|SUPERIORITY||Odds Ratio (OR)|0.88||||0.89|TWO_SIDED|95.0|0.16|4.88|||Regression, Logistic|||||4.88|0.16|0.89
70898647|NCT02279043|141285352|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||||||0.28
70898648|NCT02279043|141285353|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
70898649|NCT02279043|141285353|SUPERIORITY||Slope|0.59||||0.02|TWO_SIDED|95.0|0.08|1.11|||Regression, Linear|||Multivariate analysis adjusting for cluster, as association was significant in bivariate test.||1.11|0.08|0.02
70898650|NCT02279043|141285354|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||||||0.59
70898651|NCT02279043|141285355|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
70898652|NCT02279043|141285356|SUPERIORITY||Odds Ratio (OR)|1.29||||0.34|TWO_SIDED|95.0|0.75|2.2|||Regression, Logistic|||||2.20|0.75|0.34
70898653|NCT02279043|141285357|SUPERIORITY||Odds Ratio (OR)|1.0||||0.99|TWO_SIDED|95.0|0.49|2.05|||Regression, Logistic|||||2.05|0.49|0.99
70898654|NCT02279043|141285358|SUPERIORITY||Odds Ratio (OR)|1.48||||0.08|TWO_SIDED|95.0|0.95|2.29|||Regression, Logistic|||||2.29|0.95|0.08
70898655|NCT02279043|141285359|SUPERIORITY||Odds Ratio (OR)|1.63||||0.03|TWO_SIDED|95.0|1.05|2.58|||Regression, Logistic|||||2.58|1.05|0.03
70898656|NCT02279043|141285359|SUPERIORITY||Slope|0.5||||0.03|TWO_SIDED|95.0|0.04|0.97|||Mixed Models Analysis|Mixed effects logistic regression||Multivariate analysis adjusting for cluster, as association was significant in bivariate test.||0.97|0.04|0.03
70898657|NCT02279043|141285360|SUPERIORITY||Odds Ratio (OR)|2.25|||<|0.01|TWO_SIDED|95.0|1.42|3.56|||Regression, Logistic|||||3.56|1.42|<0.01
70898658|NCT02279043|141285360|SUPERIORITY||Slope|0.84|||<|0.01|TWO_SIDED|95.0|0.33|1.35|||Mixed Models Analysis|Mixed effects logistic regression||Multivariate analysis adjusting for cluster, as association was significant in bivariate test.||1.35|0.33|<0.01
70898659|NCT02279043|141285361|SUPERIORITY||Odds Ratio (OR)|1.02||||0.93|TWO_SIDED|95.0|0.52|2.74|||Regression, Logistic|||||2.74|0.52|0.93
70898660|NCT02279043|141285362|SUPERIORITY||Odds Ratio (OR)|1.19||||0.68|TWO_SIDED|95.0|0.52|2.74|||Regression, Logistic|||||2.74|0.52|0.68
70898661|NCT02279043|141285363|SUPERIORITY||Odds Ratio (OR)|1.24||||0.33|TWO_SIDED|95.0|0.08|1.93|||Regression, Logistic|||||1.93|0.08|0.33
70898662|NCT03848403|141285364|SUPERIORITY||Least Squares (LS) Means Difference|-21.69|||<|0.0001|TWO_SIDED|95.0|-26.9|-16.48|||Mixed Models Analysis|||||-16.48|-26.90|<0.0001
70898663|NCT03848403|141285364|SUPERIORITY||LS Means Difference|-21.14|||<|0.0001|TWO_SIDED|95.0|-26.39|-15.88|||Mixed Models Analysis|||||-15.88|-26.39|<0.0001
70898664|NCT03848403|141285364|SUPERIORITY||LS Means Difference|0.55||||0.8341|TWO_SIDED|95.0|-4.65|5.75|||Mixed Models Analysis|||||5.75|-4.65|0.8341
70898665|NCT00774579|141285369|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.6
70898666|NCT00774579|141285370|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
70898667|NCT01499082|141285436|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"Stepwise closed testing approach was used to assess non-inferiority and superiority sequentially:~1. Non-inferiority of HOE901-U300 vs Lantus: Upper bound of two-sided 95% confidence interval (CI) of difference between HOE901-U300 and Lantus on mITT population is \<0.4%.~2. Superiority (only if non-inferiority has been demonstrated): Upper bound of two-sided 95% CI for difference in mean change in HbA1c from baseline to endpoint between HOE901-U300 and Lantus on mITT population is \<0."|Least Squares (LS) Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.056|||TWO_SIDED|95.0|-0.112|0.107||||||Analysis was performed using an analysis of covariance (ANCOVA) model with treatment, strata of screening HbA1c (\<8.0 and \>=8.0%), and country as fixed effects and using the HbA1c baseline value as a covariate.||0.107|-0.112|
70898668|NCT01499082|141285437|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.79||||0.0045|TWO_SIDED|95.0|0.67|0.93|||Cochran-Mantel-Haenszel|||A one-sided test (at alpha=0.025) for superiority of HOE901-U300 over Lantus was to be performed in case the non-inferiority of HOE901-U300 vs Lantus for the primary endpoint was demonstrated. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with treatment as a factor and stratified on strata of screening HbA1c (\<8.0 and \>=8.0%).||0.93|0.67|0.0045
70898669|NCT01499082|141285438|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.162||0.6909|TWO_SIDED|95.0|-0.383|0.254|||ANCOVA|||Change in pre-injection SMPG was analyzed using an ANCOVA model with treatment, strata of screening HbA1c (\<8.0 and \>=8.0%), and country as fixed effects and using the pre-injection SMPG baseline value as a covariate. A test for superiority of HOE901-U300 over Lantus was to be performed one-sided at level alpha = 0.025 if previous analysis for nocturnal hypoglycemia was significant.||0.254|-0.383|0.6909
70898670|NCT01499082|141285447|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.123|||TWO_SIDED|95.0|-0.189|0.298||||||Analysis was performed using Analysis of covariance (ANCOVA) model with treatment regimen and country as fixed effects and baseline HbA1c value as a covariate.||0.298|-0.189|
70898671|NCT02638948|141285448|SUPERIORITY||Estimate of Difference (%)|4.9||||0.5224|TWO_SIDED|95.0|-10.2|20.1||Threshold for significance = 0.05|Chi-squared|||||20.1|-10.2|0.5224
70898672|NCT02638948|141285448|SUPERIORITY||Estimate of Difference (%)|11.8||||0.136|TWO_SIDED|95.0|-3.6|27.2||Threshold for significance = 0.05|Chi-squared|||||27.2|-3.6|0.1360
70898673|NCT02638948|141285448|SUPERIORITY||Estimate of Difference (%)|0.1||||0.9922|TWO_SIDED|95.0|-20.5|20.7||Threshold for significance = 0.05|Chi-squared|||||20.7|-20.5|0.9922
70898674|NCT02638948|141285449|SUPERIORITY||Estimate of Difference (%)|0.1||||1|TWO_SIDED|95.0|-16.0|16.5||Threshold for significance = 0.05|Chi-squared|||||16.5|-16.0|1.0000
70898675|NCT02638948|141285449|SUPERIORITY||Estimate of Difference (%)|5.6||||0.2058|TWO_SIDED|95.0|-10.5|21.9||Threshold for significance = 0.05|Chi-squared|||||21.9|-10.5|0.2058
70898676|NCT02638948|141285449|SUPERIORITY||Estimate of Difference (%)|-0.2||||1|TWO_SIDED|95.0|-22.5|22.2||Threshold for significance = 0.05|Chi-squared|||||22.2|-22.5|1.0000
70898677|NCT02963974|141285473|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analyzed CNC Word scores from 3 months through 24 months to evaluate change over time with device use. Scores were converted to Rau prior to analysis.||||< 0.001
70898678|NCT02963974|141285473|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||Analyzed pre-op to 3 month post activation CNC Word scores to test superiority of cochlear implant use to pre-operative hearing aid use.||||< 0.001
70898679|NCT02963974|141285475|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was \< 0.05. This was a two-way repeated measures ANOVA.|ANOVA|||Analyzed BKB-SIN SNR-50 scores at 12 months post activation to evaluate the impact of device use (CI off vs on) and masker location (front, to the affected ear, or to the normal hearing ear) on hearing in noise.||||< 0.001
70898680|NCT02963974|141285476|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analyzed BKB-SIN SNR-50 scores across all time points (6, 12, and 24 months post activation) to evaluate the impact of time, device use (CI off vs on), and masker location (front, to the affected ear, or to the normal hearing ear) on hearing in noise.||||< 0.001
70898681|NCT02963974|141285480|SUPERIORITY|||||||0.01911||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analyzed overall RMS error at 3, 9, 18, and 24 months post activation to evaluate the impact of device use (CI off vs on) and time on localization.||||0.01911
70898682|NCT02963974|141285481|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was p \< 0.05|Mixed Models Analysis|||Comparison of scores across time to investigate change in scores over time: Speech subtest.||||< 0.001
70898683|NCT02963974|141285481|SUPERIORITY|||||||0.001||||||The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|||Comparison of scores across time to investigate change in scores over time: Spatial subtest.||||0.001
70898684|NCT02963974|141285481|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|||Comparison of scores across time to investigate change in scores over time: Qualities subtest.||||< 0.001
70898685|NCT02963974|141285482|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was p \< 0.05|Mixed Models Analysis|||Comparison of scores over time.||||< 0.001
70898686|NCT02963974|141285483|SUPERIORITY|||||||0.1009||||||The a priori threshold for statistical significance was p \< 0.05|Mixed Models Analysis|||Comparison of scores to evaluation change over time: General Fatigue Subtest||||0.1009
70898687|NCT02963974|141285483|SUPERIORITY|||||||0.109||||||The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|||Comparison of scores to evaluation change over time: Sleep Fatigue Subtest||||0.109
70898688|NCT02963974|141285483|SUPERIORITY|||||||0.1733||||||The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|||Comparison of scores to evaluation change over time: Cognitive Fatigue Subtest||||0.1733
70898689|NCT00810264|141285484|NON_INFERIORITY|The primary safety endpoint 1 hypothesis was evaluated by performing an exact, non-inferiority test comparing a binomial proportion (overall SAEFR at 5 years) to 92.5%, with a non-inferiority delta of 5%.|||||<|0.0001|||||||Binomial Proportion|||||||<0.0001
70898690|NCT00567190|141285510|SUPERIORITY||Cox Proportional Hazard|0.62|||<|0.0001|TWO_SIDED|95.0|0.51|0.75||Tested at two-sided 5% significance level|Log Rank (stratified)|Stratified by prior treatment status and region|Hazard ratio is comparing Pertuzumab arm with Placebo arm.|The null hypothesis (H0) was that the survival distributions of PFS in the two treatments arms (pertuzumab vs. placebo) are the same. The alternative hypothesis (H1) was that the survival distribution of PFS in the experimental arm (pertuzumab) and control arm (placebo) are different.||0.75|0.51|<0.0001
70898691|NCT00567190|141285510|SUPERIORITY||Cox Proportional Hazard|0.63|||<|0.0001|TWO_SIDED|95.0|0.52|0.76||Tested at two-sided 5% significance level|Log Rank (unstratified)|Unstratified|Hazard ratio is comparing Pertuzumab arm with Placebo arm.|The null hypothesis (H0) was that the survival distributions of PFS in the two treatments arms (pertuzumab vs. placebo) are the same. The alternative hypothesis (H1) was that the survival distribution of PFS in the experimental arm (pertuzumab) and control arm (placebo) are different.||0.76|0.52|<0.0001
70898692|NCT00567190|141285511|SUPERIORITY|Exploratory|Cox Proportional Hazard|0.69|||<|0.0001|TWO_SIDED|95.0|0.58|0.82||Exploratory|Log Rank (stratified)|Stratified by prior treatment status and region.|Hazard ratio is comparing Pertuzumab arm with Placebo arm.|End-of-Study OS Analysis: This end-of-study OS analysis is considered exploratory only as the confirmatory OS analysis for statistical interpretation had previously occurred at the second interim OS analysis.||0.82|0.58|<0.0001
70898693|NCT00567190|141285511|SUPERIORITY|Exploratory|Cox Proportional Hazard|0.68||||0.0002|TWO_SIDED|95.0|0.56|0.84||Exploratory|Log Rank (stratified)|Stratified by prior treatment status and region.|Hazard ratio is comparing Pertuzumab arm with Placebo arm.|Event-Driven Final OS Analysis: This final OS analysis was event-driven and planned to take place after a total of 385 deaths had occurred. It is considered exploratory only as the confirmatory OS analysis for statistical interpretation had previously occurred at the second interim OS analysis.||0.84|0.56|0.0002
70898694|NCT00567190|141285511|SUPERIORITY||Cox Proportional Hazard|0.66||||0.0008|TWO_SIDED|95.0|0.52|0.84||The threshold for statistical significance was HR≤0.739, p≤0.0138.|Log Rank (stratified)|Stratified by prior treatment status and region.|Hazard ratio (HR) is comparing Pertuzumab arm with Placebo arm.|Second Interim OS Analysis: For this second interim OS analysis, the pre-defined O'Brien-Fleming stopping boundary for the Lan-DeMets α-spending function was: HR≤0.739, p≤0.0138.||0.84|0.52|0.0008
70898695|NCT00567190|141285511|SUPERIORITY||Cox Proportional Hazard|0.64||||0.005|TWO_SIDED|95.0|0.47|0.88||The threshold for statistical significance was HR≤0.603, p≤0.0012.|Log Rank (stratified)|Stratified by prior treatment status and region.|Hazard ratio (HR) is comparing pertuzumab with placebo arms.|First Interim OS Analysis: For this first interim OS analysis, the pre-defined O'Brien-Fleming stopping boundary for the Lan-DeMets α-spending function was: HR≤0.603, p≤0.0012.||0.88|0.47|0.0050
70898696|NCT00567190|141285512|SUPERIORITY||Cox Proportional Hazard|0.69|||<|0.0001|TWO_SIDED|95.0|0.59|0.81|||Log Rank (stratified)|Stratified by prior treatment status and region.|Hazard ratio is comparing Pertuzumab arm with Placebo arm.|PFS by Investigator - Stratified||0.81|0.59|<0.0001
70898697|NCT00567190|141285513|SUPERIORITY||Difference in Objective Response Rates|10.83||||0.0011|TWO_SIDED|95.0|4.2|17.5|||Mantel Haenszel|Stratified by prior treatment status and region.|Difference in the objective response rates between arms is calculated as Pertuzumab arm minus Placebo arm. The 95% CI was calculated using the Hauck-Anderson method.|Difference in Objective Response (CR + PR) Between Arms||17.5|4.2|0.0011
70898698|NCT00567190|141285513|SUPERIORITY||Odds Ratio (OR)|1.79|||||TWO_SIDED|95.0|1.26|2.54||||||Odds Ratio for Objective Response (CR + PR)||2.54|1.26|
70898699|NCT00567190|141285514|SUPERIORITY||Cox Proportional Hazard|0.66|||||TWO_SIDED|95.0|0.51|0.85||||||||0.85|0.51|
70898700|NCT00567190|141285515|SUPERIORITY||Cox Proportional Hazard|0.97||||0.7161|TWO_SIDED|95.0|0.81|1.16||Stratified by prior treatment status and region.|Log Rank (stratified)||Hazard ratio is comparing Pertuzumab arm with Placebo arm.|||1.16|0.81|0.7161
70898701|NCT00567190|141285524|OTHER|||||||0.7174|||||||Wilcoxon Rank Sum Test|||Wilcoxon Test of Maximum Decrease in LVEF From BL||||0.7174
70898702|NCT00313820|141285531|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.29||0.578||95.0|-0.7|0.4|||ANCOVA|ANCOVA with treatment and country as factors and baseline pain score as covariate.||Modelled Results: Endpoint Mean Pain Score Pregabalin vs Placebo||0.4|-0.7|0.578
70898703|NCT00313820|141285531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.294||95.0||||Interaction p-value based on adding interaction term to the main model.|ANCOVA|||Modelled Results: Treatment by country interaction||||0.294
70898704|NCT00313820|141285532|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.25||0.161||95.0|-0.8|0.1||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 1 Modelled Results||0.1|-0.8|0.161
70898705|NCT00313820|141285532|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.25||0.062||95.0|-1.0|0.0||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 2 Modelled Results||0.0|-1.0|0.062
70898706|NCT00313820|141285532|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.25||0.024||95.0|-1.1|-0.1||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 3 Modelled Results||-0.1|-1.1|0.024
70898707|NCT00313820|141285532|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.25||0.026||95.0|-1.1|-0.1||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 6 Modelled Results||-0.1|-1.1|0.026
70898708|NCT00313820|141285532|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.25||0.105||95.0|-0.9|0.1||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 9 Modelled Results||0.1|-0.9|0.105
70898709|NCT00313820|141285532|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.25||0.592||95.0|-0.6|0.4||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 12 Modelled Results||0.4|-0.6|0.592
70898710|NCT00313820|141285533|SUPERIORITY_OR_OTHER_LEGACY|||||||0.087||95.0||||Cochran-Mantel-Haenszel (CMH) test comparing pregabalin to placebo adjusted for country under the null hypothesis of no treatment difference.|Cochran-Mantel-Haenszel|||30% Responders||||0.087
70898711|NCT00313820|141285534|SUPERIORITY_OR_OTHER_LEGACY|||||||0.622||95.0||||Cochran-Mantel-Haenszel (CMH) test comparing pregabalin to placebo adjusted for country under the null hypothesis of no treatment difference.|Cochran-Mantel-Haenszel|||50% Responders||||0.622
70898712|NCT00313820|141285535|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.23||0.027||95.0|-1.0|-0.1||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 1; Modelled Results||-0.1|-1.0|0.027
70898713|NCT00313820|141285535|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.038||95.0|-1.0|0.0||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 2; Modelled Results||-0.0|-1.0|0.038
70898714|NCT00313820|141285535|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.24||0.004||95.0|-1.2|-0.2||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 3; Modelled Results||-0.2|-1.2|0.004
70898715|NCT00313820|141285535|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.24||0.005||95.0|-1.1|-0.2||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 6; Modelled Results||-0.2|-1.1|0.005
70898716|NCT00313820|141285535|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.078||95.0|-0.9|0.0||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 9; Modelled Results||0.0|-0.9|0.078
70898717|NCT00313820|141285535|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.663||95.0|-0.6|0.4||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 12; Modelled Results||0.4|-0.6|0.663
70898718|NCT00313820|141285535|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.627||95.0|-0.6|0.4||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Endpoint \[Week 12 or ET\]; Modelled Results||0.4|-0.6|0.627
70898719|NCT00313820|141285536|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|3.05||0.741||95.0|-7.0|5.0||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline value as a covariate|ANCOVA|||Modelled Results||5.0|-7.0|0.741
70898720|NCT00313820|141285537|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.31||0.216||95.0|-1.0|0.2||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Burning Pain Week 12 \[LOCF\]; Modelled Results||0.2|-1.0|0.216
70898721|NCT00313820|141285537|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.25||0.76||95.0|-0.4|0.6||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Pressing Pain Week 12 \[LOCF\]; Modelled Results||0.6|-0.4|0.760
70898722|NCT00313820|141285537|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.36||95.0|-0.7|0.3||Estimated from ANCOVA (general linear model) general linear model with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Paroxysmal Pain Week 12 \[LOCF\]; Modelled Results||0.3|-0.7|0.360
70898723|NCT00313820|141285537|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.26||0.239||95.0|-0.8|0.2||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Evoked Pain Week 12 \[LOCF\]; Modelled Results||0.2|-0.8|0.239
70898724|NCT00313820|141285537|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.27||0.118||95.0|-1.0|0.1||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||P/D Week 12 \[LOCF\]; Modelled Results||0.1|-1.0|0.118
70898725|NCT00313820|141285537|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.8|STANDARD_ERROR_OF_MEAN|1.87||0.138||95.0|-6.5|0.9||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Total Score Week 12 \[LOCF\]; Modelled Results||0.9|-6.5|0.138
70898726|NCT00313820|141285538|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|2.79||0.086||95.0|-10.3|0.7||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Sleep disturbance; Modelled Results||0.7|-10.3|0.086
70898727|NCT00313820|141285538|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.7|STANDARD_ERROR_OF_MEAN|3.72||0.039||95.0|0.4|15.1||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Snoring score; Modelled Results||15.1|0.4|0.039
70898728|NCT00313820|141285538|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|2.71||0.169||95.0|-9.1|1.6||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Awaken SOB or headache; Modelled Results||1.6|-9.1|0.169
70898729|NCT00313820|141285538|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.17||0.03||95.0|0.0|0.7||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Sleep quantity; Modelled Results||0.7|0.0|0.030
70898730|NCT00313820|141285538|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|3.44||0.013||95.0|1.8|15.4||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Sleep adequacy; Modelled Results||15.4|1.8|0.013
70898731|NCT00313820|141285538|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|2.51||0.399||95.0|-2.8|7.1||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Somnolence; Modelled Results||7.1|-2.8|0.399
70898732|NCT00313820|141285538|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|2.13||0.049||95.0|-8.4|0.0||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Overall sleep problems index; Modelled Results||-0.0|-8.4|0.049
70898733|NCT00313820|141285539|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.5|STANDARD_ERROR_OF_MEAN|0.5||0.201||95.0|0.8|2.9||Estimated from a logistic regression model with treatment and the baseline assessment as factors.|Regression, Logistic||Standard error of the mean = standard error of the odds ratio.|Modelled Results||2.9|0.8|0.201
70898734|NCT00313820|141285540|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.015||95.0|-1.8|-0.2||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Week 12 \[LOCF\] Anxiety score; Modelled Results||-0.2|-1.8|0.015
70898735|NCT00313820|141285540|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.41||0.6||95.0|-0.6|1.0||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Week 12 \[LOCF\] Depression score; Modelled Results||1.0|-0.6|0.600
70898736|NCT00313820|141285541|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.04||0.566||95.0|-0.1|0.1||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Modelled Results||0.1|-0.1|0.566
70898737|NCT00313820|141285542|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|2.47||0.22||95.0|-1.8|7.9||Estimated from ANCOVA (general linear model) with treatment and coutntry as factors and baseline score as a covariate.|ANCOVA|||Modelled Results||7.9|-1.8|0.220
70898738|NCT00313820|141285543|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.144||95.0|-0.5|0.1||Estimated from ANCOVA (general linear model) with treament and country as factors.|ANCOVA|||Modelled Results||0.1|-0.5|0.144
70898739|NCT00313820|141285544|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.049||95.0|-0.6|0.0||Estimated from ANCOVA (general linear model) with treatment and country as factors.|ANCOVA|||Modelled Results||-0.0|-0.6|0.049
70898740|NCT01515748|141285548|SUPERIORITY|||||||0.0152||||||Threshold for statistical significance at 0.049.|Stratified Log Rank|||Analysis was performed using Kaplan-Meier method. Comparison was stratified based on site and TNM classification (T4/N-, T2/N+, T3-4/N+).||||0.0152
70898741|NCT04102579|141285564|OTHER||Least Squares (LS) Means Difference|-3.16|STANDARD_ERROR_OF_MEAN|0.61|<|0.0001|TWO_SIDED|95.0|-4.37|-1.95||Statistical significance achieved if p-value \<0.05.|MMRM||LS Means Difference = Valbenazine - Placebo|Results were analyzed using a mixed-effect model repeated measures (MMRM) analysis. The model included the screening period baseline TMC as a covariate, and treatment group, visit, treatment group-by-visit interaction, and baseline-by-visit interaction as fixed effects. Participant was included as a random effect.||-1.95|-4.37|<0.0001
70898742|NCT04102579|141285565|OTHER||Percent Difference in Responders|29.65||||0.0007|TWO_SIDED|95.0|10.77|45.37||Statistical significance achieved if p-value \<0.05.|Fisher Exact||Percent Difference in Responders (%) = Valbenazine - Placebo|||45.37|10.77|0.0007
70898743|NCT04102579|141285566|OTHER||Percent Difference in Responders|26.31||||0.0062|TWO_SIDED|95.0|6.32|43.74||Statistical significance achieved if p-value \<0.05.|Fisher Exact||Percent Difference in Responders (%) = Valbenazine - Placebo|||43.74|6.32|0.0062
70898744|NCT04102579|141285567|OTHER||LS Means Difference|1.42|STANDARD_ERROR_OF_MEAN|1.46||0.3304|TWO_SIDED|95.0|-1.46|4.31||Statistical significance achieved if p-value \<0.05.|MMRM||LS Means Difference = Valbenazine - Placebo|LS mean was based on the MMRM model which included corresponding baseline value of the Neuro-QoL Upper Extremity Function T-score as a covariate; treatment group, visit, baseline-by-visit interaction, and treatment group-by-visit interaction as fixed effects; and participant as a random effect.||4.31|-1.46|0.3304
70898745|NCT00662857|141285592|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.982|||||TWO_SIDED|90.0|0.846|1.141|||||"Geometric Mean Ratio of serum insulin from a single 30 U cartridge to 2 x 15 U cartridges of TI.~Based on pair-wise comparisons from analysis of covariance fitting the model: natural log of parameter = cohort, treatment, visit, subject (cohort)."|||1.141|0.846|
70898746|NCT00662857|141285593|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.951|||||TWO_SIDED|90.0|0.823|1.099|||||"Geometric Mean Ratio of serum insulin from a single 30 U cartridge to 2 x 15 U cartridges of TI.~Based on pair-wise comparisons from analysis of covariance fitting the model: natural log of parameter = cohort, treatment, visit, subject (cohort)."|||1.099|0.823|
70898747|NCT00662857|141285594|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.3531|||||||Signed Rank Test|||||||0.3531
70898748|NCT00662857|141285595|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.46|||||TWO_SIDED|90.0|0.366|0.578|||||"Geometric Mean Ratio of serum insulin from a single 30 U cartridge of TI to 10 U sc insulin lispro.~Based on pair-wise comparisons from analysis of covariance fitting the model: natural log of parameter = cohort, treatment, visit, subject (cohort)."|||0.578|0.366|
70898749|NCT02563002|141285617|OTHER||Hazard Ratio (HR)|0.59||||0.0001|TWO_SIDED|95.0|0.45|0.79|||Log Rank|One-sided p-value based on log rank test|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||0.79|0.45|0.0001
70898750|NCT02563002|141285618|OTHER||Hazard Ratio (HR)|0.74||||0.0359|TWO_SIDED|95.0|0.53|1.03|||Log Rank|One-sided p-value based on log rank test|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.03|0.53|0.0359
70898751|NCT02563002|141285619|OTHER||Difference in percentage|12.0||||0.0159|TWO_SIDED|95.0|1.0|22.6||One-sided p-value based on Miettinen \& Nurminen method.|Miettinen & Nurminen method||Based on Miettinen \& Nurminen method.|||22.6|1.0|0.0159
70898752|NCT02152982|141285751|SUPERIORITY|||||||0.1462|||||||Log Rank|||||||0.1462
70898753|NCT02152982|141285752|SUPERIORITY||Cox Proportional Hazard|1.02||||0.9101|TWO_SIDED|95.0|0.7|1.5|||Type 3 likelihood-ratio p-value|||||1.50|0.70|0.9101
70898754|NCT02152982|141285753|SUPERIORITY||Cox Proportional Hazard|1.05||||0.3059|TWO_SIDED|95.0|0.86|1.29|||Log Rank|||||1.29|0.86|0.3059
70898755|NCT02152982|141285754|SUPERIORITY|||||||0.6827|||||||Chi-squared|||||||0.6827
70898756|NCT02152982|141285755|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
70898757|NCT03574597|141285775|SUPERIORITY||Hazard Ratio (HR)|0.8|||<|0.0001|TWO_SIDED|95.0|0.72|0.89|||Regression, Cox|||Data from the in-trial period. The outcome measure was analysed using a Cox proportional hazards model with treatment as categorical fixed factor. Participants without events of interest were censored at the end of their in-trial period.||0.89|0.72|< 0.0001
70898758|NCT06060457|141285816|OTHER||Geometric Mean Ratio (GMR)|0.625|||||TWO_SIDED|95.0|0.57|0.686||||||RSV-A: Arm 1 versus Arm 2||0.686|0.570|
70898759|NCT06060457|141285816|OTHER||GMR|0.638|||||TWO_SIDED|95.0|0.584|0.697||||||RSV-B: Arm 1 versus Arm 2||0.697|0.584|
70898760|NCT00406133|141285870|SUPERIORITY_OR_OTHER|||||||0.29||||||"A P value of 0.0167 was considered the significance level for the primary analysis in each age group to maintain an overall type I error rate of 0.05.~P value is for age 8-14 group."|ANCOVA|Performed in each age group and adjusted for the baseline A1c and clinical center.||The study was to test whether the use of CGM will lower A1c at 26 weeks. The estimated sample size was 110 for each age group, which will provide 90% power to detect a difference between treatment groups in each of the age groups assuming a population difference of 0.5%, a two-tailed test with type I error rate of 5%, standard deviation of the 6 month HbA1c values of 0.9, correlation between baseline and 26-week values of 0.58.||||0.29
70898761|NCT00406133|141285870|SUPERIORITY_OR_OTHER|||||||0.52||||||"A P value of 0.0167 was considered the significance level for the primary analysis in each age group to maintain an overall type I error rate of 0.05.~P value for age 15-24 group."|ANCOVA|Performed in each age group and adjusted for the baseline A1c and clinical center.||||||0.52
70898762|NCT00406133|141285870|SUPERIORITY_OR_OTHER||||||<|0.001||||||"A P value of 0.0167 was considered the significance level for the primary analysis in each age group to maintain an overall type I error rate of 0.05.~P value is for age \>=25 group."|ANCOVA|Performed in each age group and adjusted for the baseline A1c and clinical center.||||||<0.001
70898763|NCT00406133|141285871|SUPERIORITY_OR_OTHER|||||||0.16||||||P-value was for the comparison of RT-CGM group and Control group.|ANCOVA|Based on the ranks of the 26wk values using VDW scores, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.||A sample size of 120 subjects was planned to have 90% power to detect a difference in this outcome between treatment groups, assuming a population difference of 29 min/day, standard deviation of the 26-week values of 59 min/day, correlation between baseline and 26-week values of 0.66, an α=0.05, and no more than 15% losses to follow-up.||||0.16
70898764|NCT00406133|141285872|SUPERIORITY_OR_OTHER|||||||0.74||||||P-value is for N(%) of subjects with \>=1 severe hypo event in the 8-14 year age group.|Fisher Exact|||The proportions of patients experiencing one or more severe hypoglycemic events in each treatment group were compared using Fisher's exact test. Incidences of hypoglycemic events were compared and confidence intervals for the treatment group difference calculated using permutation tests. Similar analyses were performed for the subset of hypoglycemic events associated with seizure or coma.||||0.74
70898765|NCT00406133|141285872|SUPERIORITY_OR_OTHER|||||||0.48||||||P-value is for N(%) of subjects with \>=1 severe hypo event in the 15-24 year age group.|Fisher Exact|||||||0.48
70898766|NCT00406133|141285872|SUPERIORITY_OR_OTHER|||||||1||||||P-value is for N(%) of subjects with \>=1 severe hypo event in the \>=25 year age group.|Fisher Exact|||||||1.0
70898767|NCT00406133|141285872|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED|95.0||||P-value is for N(%) of subjects with \>=1 severe hypo event with seizure or comma in the 8-14 year age group.|Fisher Exact|||The proportions of patients experiencing one or more severe hypoglycemic events in each treatment group were compared using Fisher's exact test. Incidences of hypoglycemic events were compared and confidence intervals for the treatment group difference calculated using permutation tests. Similar analyses were performed for the subset of hypoglycemic events associated with seizure or coma.||||0.74
70898768|NCT00406133|141285872|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|95.0||||P-value is for N(%) of subjects with \>=1 severe hypo event with seizure or comma in the 15-24 year age group.|Fisher Exact|||The proportions of patients experiencing one or more severe hypoglycemic events in each treatment group were compared using Fisher's exact test. Incidences of hypoglycemic events were compared and confidence intervals for the treatment group difference calculated using permutation tests. Similar analyses were performed for the subset of hypoglycemic events associated with seizure or coma.||||0.48
70898769|NCT00406133|141285872|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|95.0||||P-value is for N(%) of subjects with \>=1 severe hypo event with seizure or comma in the \>=25 year age group.|Fisher Exact|||The proportions of patients experiencing one or more severe hypoglycemic events in each treatment group were compared using Fisher's exact test. Incidences of hypoglycemic events were compared and confidence intervals for the treatment group difference calculated using permutation tests. Similar analyses were performed for the subset of hypoglycemic events associated with seizure or coma.||||1.0
70898770|NCT00406133|141285873|SUPERIORITY_OR_OTHER|||||||0.53||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (\<=70 mg/dL and \<=50 mg/dL), hyperglycemic (\>180 mg/dL and \>250 mg/dL), and in the target range (71 to 180 mg/dL).||||0.53
70898771|NCT00406133|141285873|SUPERIORITY_OR_OTHER|||||||0.79||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.79
70898772|NCT00406133|141285873|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.|ANCOVA|||||||<0.001
70898773|NCT00406133|141285874|SUPERIORITY_OR_OTHER|||||||0.58||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (\<=70 mg/dL and \<=50 mg/dL), hyperglycemic (\>180 mg/dL and \>250 mg/dL), and in the target range (71 to 180 mg/dL).||||0.58
70898774|NCT00406133|141285874|SUPERIORITY_OR_OTHER|||||||0.85||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.85
70898775|NCT00406133|141285874|SUPERIORITY_OR_OTHER|||||||0.002||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.002
70898776|NCT00406133|141285875|SUPERIORITY_OR_OTHER|||||||0.18||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (\<=70 mg/dL and \<=50 mg/dL), hyperglycemic (\>180 mg/dL and \>250 mg/dL), and in the target range (71 to 180 mg/dL).||||0.18
70898777|NCT00406133|141285875|SUPERIORITY_OR_OTHER|||||||0.44||||||P-value for the comparison of treatment groups at 26wks adjusting for the baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.44
70898778|NCT00406133|141285875|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||<0.001
70898779|NCT00406133|141285876|SUPERIORITY_OR_OTHER|||||||0.29||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (\<=70 mg/dL and \<=50 mg/dL), hyperglycemic (\>180 mg/dL and \>250 mg/dL), and in the target range (71 to 180 mg/dL).||||0.29
70898780|NCT00406133|141285876|SUPERIORITY_OR_OTHER|||||||0.79||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.79
70898781|NCT00406133|141285876|SUPERIORITY_OR_OTHER|||||||0.41||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.41
70898782|NCT00406133|141285877|SUPERIORITY_OR_OTHER|||||||0.5||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (\<=70 mg/dL and \<=50 mg/dL), hyperglycemic (\>180 mg/dL and \>250 mg/dL), and in the target range (71 to 180 mg/dL).||||0.50
70898783|NCT00406133|141285877|SUPERIORITY_OR_OTHER|||||||0.99||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.99
70898784|NCT00406133|141285877|SUPERIORITY_OR_OTHER|||||||0.1||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.10
70898785|NCT00406133|141285878|SUPERIORITY_OR_OTHER|||||||0.66||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Glucose variability was assessed by computing the absolute rate of change.||||0.66
70898786|NCT00406133|141285878|SUPERIORITY_OR_OTHER|||||||0.48||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.48
70898787|NCT00406133|141285878|SUPERIORITY_OR_OTHER|||||||0.07||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.07
70898788|NCT00406133|141285879|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|Adjusted for baseline A1c and clinical center.||Other preplanned secondary outcomes included change in A1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline A1c and clinical center).||||<0.001
70898789|NCT00406133|141285880|SUPERIORITY_OR_OTHER||||||<|0.001||||||Based on the ranks of the 26wk values using VDW scores, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.|ANCOVA|Adjusted for baseline value, clinical center and type of continuous glucose monitor.||Percentages of values less than or greater than a given threshold were converted to minutes per day by multiplying by 1,440. A nonparametric approach was followed using an ANCOVA based on ranks of the 26 week values, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.||||<0.001
70898790|NCT00406133|141285881|SUPERIORITY_OR_OTHER|||||||0.03||||||P-value representative of 13 and 26 weeks combined.|ANCOVA|||Percentages of values less than or greater than a given threshold were converted to minutes per day by multiplying by 1,440. A nonparametric approach was followed using an ANCOVA based on ranks of the 26 week values, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.||||0.03
70898791|NCT00406133|141285882|SUPERIORITY_OR_OTHER|||||||0.04||||||P-value for the 8-14 year old age group|Regression, Logistic|||Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by \>=10%, 26-week level \<7.0%, absolute decrease by \>=0.5%, relative increase by \>=10%, absolute increase by \>=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.||||0.04
70898792|NCT00406133|141285882|SUPERIORITY_OR_OTHER|||||||0.46||||||P-value for the 15-24 year age group|Regression, Logistic|||||||0.46
70898793|NCT00406133|141285882|SUPERIORITY_OR_OTHER|||||||0.003||||||P-value for the \>=25 year age group|Regression, Logistic|||||||0.003
70898794|NCT00406133|141285883|SUPERIORITY_OR_OTHER|||||||0.24||||||P-value for 8-14 year old age group|Regression, Logistic|||Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by \>=10%, 26-week level \<7.0%, absolute decrease by \>=0.5%, relative increase by \>=10%, absolute increase by \>=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.||||0.24
70898795|NCT00406133|141285883|SUPERIORITY_OR_OTHER|||||||0.98||||||P-value for the 15-24 year old age group|Regression, Logistic|||||||0.98
70898796|NCT00406133|141285883|SUPERIORITY_OR_OTHER|||||||0.48||||||P-value for the \>=25 year old age group|Regression, Logistic|||||||0.48
70898797|NCT00406133|141285884|SUPERIORITY_OR_OTHER|||||||0.005||||||P-value representative of 13 and 26 weeks combined|ANCOVA|||Percentages of values less than or greater than a given threshold were converted to minutes per day by multiplying by 1,440. A nonparametric approach was followed using an ANCOVA based on ranks of the 26 week values, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.||||0.005
70898798|NCT00406133|141285885|SUPERIORITY_OR_OTHER|||||||0.05||||||P-value representative of 13 and 26 weeks combined.|ANCOVA|||Percentages of values less than or greater than a given threshold were converted to minutes per day by multiplying by 1,440. A nonparametric approach was followed using an ANCOVA based on ranks of the 26 week values, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.||||0.05
70898799|NCT00406133|141285886|SUPERIORITY_OR_OTHER|||||||0.39||||||P-value representative of 13 and 26 weeks combined.|ANCOVA|||Glucose variability was assessed by computing the absolute rate of change.||||0.39
70898800|NCT00406133|141285887|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|||||Nominal p-value not adjusted for multiple comparisons|ANCOVA|||||||0.04
70898801|NCT00406133|141285888|SUPERIORITY_OR_OTHER||Ratio of treatment differences|408148.0|||||TWO_SIDED|95.0|-176644.0|3475108.0||||||"ICER = Incremental Cost Effectiveness Ratio is defined as the mean difference in costs between the treatment groups divided by the mean difference in QALY (quality-adjusted life-year) between the treatment groups:~(mean cost\[CGM\] - mean cost \[control\]) / (mean QALY\[CGM\] - mean QALY\[SMBG\]).~Units are dollars per QALY."||3475108|-176644|
70898802|NCT00406133|141285889|SUPERIORITY_OR_OTHER|||||||0.009||||||P-value for the 8-14 year old age group|Regression, Logistic|||Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by \>=10%, 26-week level \<7.0%, absolute decrease by \>=0.5%, relative increase by \>=10%, absolute increase by \>=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.||||0.009
70898803|NCT00406133|141285889|SUPERIORITY_OR_OTHER|||||||0.57||||||P-value for 15-24 year old age group|Regression, Logistic|||||||0.57
70898804|NCT00406133|141285889|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the \>=25 year old age group|Regression, Logistic|||||||<0.001
70898805|NCT00406133|141285890|SUPERIORITY_OR_OTHER|||||||0.18||||||P-value for 8-14 year age group|Regression, Logistic|||Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by \>=10%, 26-week level \<7.0%, absolute decrease by \>=0.5%, relative increase by \>=10%, absolute increase by \>=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.||||0.18
70898806|NCT00406133|141285890|SUPERIORITY_OR_OTHER|||||||0.84||||||P-value for 15-24 year old age group.|Regression, Logistic|||||||0.84
70898807|NCT00406133|141285890|SUPERIORITY_OR_OTHER|||||||0.02||||||P-value for \>=25 year old age group.|Regression, Logistic|||||||0.02
70898808|NCT00406133|141285891|SUPERIORITY_OR_OTHER|||||||0.01||||||P-value for 8-14 year age group|Regression, Logistic|||Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by \>=10%, 26-week level \<7.0%, absolute decrease by \>=0.5%, relative increase by \>=10%, absolute increase by \>=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.||||0.01
70898809|NCT00406133|141285891|SUPERIORITY_OR_OTHER|||||||0.8||||||P-value for 14-24 year age group|Regression, Logistic|||||||0.80
70898810|NCT00406133|141285891|SUPERIORITY_OR_OTHER|||||||0.005||||||P-value for \>=25 year age group|Regression, Logistic|||||||0.005
70898811|NCT00406133|141285892|SUPERIORITY_OR_OTHER|||||||0.02||||||P-value for the 8-14 year age group|Regression, Logistic|||A post-hoc defined binary outcome of 26-week glycated hemoglobin \<7.0% with no severe hypoglycemic events was analyzed in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.||||0.02
70898812|NCT00406133|141285892|SUPERIORITY_OR_OTHER|||||||0.67||||||P-value for the 15-24 year old age group|Regression, Logistic|||||||0.67
70898813|NCT00406133|141285892|SUPERIORITY_OR_OTHER|||||||0.006||||||P-value for the \>=25 year old age group|Regression, Logistic|||||||0.006
70898814|NCT00406133|141285893|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Other preplanned secondary outcomes included change in A1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline A1c and clinical center) and 26-week binary A1c outcomes (decrease and increase in A1C from baseline by \>=0.3% and 26-week value \<7.0%) evaluated similarly using logistic regression models.||||<0.001
70898815|NCT00406133|141285894|SUPERIORITY_OR_OTHER|||||||0.002|||||||Regression, Logistic|||Other preplanned secondary outcomes included change in A1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline A1c and clinical center) and 26-week binary A1c outcomes (decrease and increase in A1C from baseline by \>=0.3% and 26-week value \<7.0%) evaluated similarly using logistic regression models.||||0.002
70898816|NCT00406133|141285895|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Other preplanned secondary outcomes included change in A1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline A1c and clinical center) and 26-week binary A1c outcomes (decrease and increase in A1C from baseline by \>=0.3% and 26-week value \<7.0%) evaluated similarly using logistic regression models.||||<0.001
70898817|NCT01895972|141285905|OTHER||||||<|0.001||||||The reduction from baseline in IOP was significant at all post-baseline assessment time points through Week 52.|t-test, 2 sided|||comparison vs. baseline||||<0.001
70898818|NCT05417620|141285916|OTHER||Incidence rate ratio|1.21||||0.707|TWO_SIDED|95.0|0.44|3.31||Threshold for significance: 0.05.|Regression, Poisson|||"This statistical analysis is done at the district level where counts of initiations in intervention districts are compared to standard of care districts. In the measure type we report rate = average counts of PrEP initiations per number of study months."||3.31|0.44|0.707
70898819|NCT02782169|141285927|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||||||0.32
70898820|NCT02953938|141285956|SUPERIORITY||Mean Difference (Net)|-0.21|STANDARD_DEVIATION|0.64||0.368|TWO_SIDED|95.0|-1.49|1.07|||Cochran-Mantel-Haenszel|||||1.07|-1.49|0.3680
70898821|NCT02953938|141285957|SUPERIORITY||Mean Difference (Final Values)|-6.58|STANDARD_DEVIATION|3.042||0.0349|TWO_SIDED|95.0|-12.67|-0.48|||ANOVA|||||-0.48|-12.67|0.0349
70898822|NCT02953938|141285958|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_DEVIATION|0.051||0.2707|TWO_SIDED|95.0|-0.045|0.158|||ANOVA|||||0.158|-0.045|0.2707
70898823|NCT02953938|141285960|SUPERIORITY||Mean Difference (Final Values)|11.32||||0.7602|TWO_SIDED|95.0|-62.65|85.28|||ANOVA|||||85.28|-62.65|0.7602
70898824|NCT02038894|141285961|NON_INFERIORITY|A previous study for evaluating respiratory complications with intubated and insufflated techniques found a difference in the incidence of respiratory complications of 9.1%, a power analysis was determined. 200 subjects per group was estimated provide 82% power to detect a difference. We elected to do an interim analysis when 60 children per group were recruited because of a clinical impression that one of the techniques had a grossly divergent incidence of respiratory complications.|Odds Ratio (OR)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.14||Threshold for significance \<0.05 Comparing SPO2 \<95%|Mean equality test|||||0.14|0|<0.0001
70898825|NCT02038894|141285961|NON_INFERIORITY|A previous study found an incidence of respiratory complications of 9.1%. 200 subjects per group was estimated provide 82% power to detect a difference when conducting a two- sided test at a significance level of a = 0.05.We did an interim analysis when 60 children per group were recruited because of a clinical impression that one of the techniques had a grossly divergent incidence of respiratory complications. Based on the results of that interim analysis, recruitment was discontinued|Odds Ratio (OR)|0.0||||0.0001|TWO_SIDED|95.0|0.0|0.27||p\<0.05. Sp02\<85%|Mean equality test||Odds ratios were calculated to the respiratory complications comparing the different groups and by regrouping by the differences in airway management (IS + IP vs NA) and by the medication used for anesthesia maintenance (IS vs IP + NA)|||0.27|0|0.0001
70898826|NCT02038894|141285962|NON_INFERIORITY|No previous data was available to calculate a power calculation for the secondary outcome.||||||0.901||||||Threshold of Significance|Mean equality test|||Total OR Time||||0.901
70898827|NCT00101933|141285963|SUPERIORITY_OR_OTHER|||||||0.0017||95.0||||Since a treatment-by-visit interaction remains in the final model, the results were analyzed by visit. The results shown are for the last month in the blinded phase (month 3-4).|Generalized Estimating Equations|This analysis is adjusted for significant baseline covariates.||The numbers presented are the percentage reduction in the number of seizures in each group. A negative percentage change indicates a seizure reduction.||||0.0017
70898828|NCT00101933|141285965|SUPERIORITY_OR_OTHER||Rate per 1000 years of stimulation|4.9|||||TWO_SIDED|95.0|0.6|17.79|||No statistical test||The rate is calculated per 1000 subject years of follow-up based on 406 subject years of stimulation. The confidence interval is the 95% Poisson confidence interval. Per protocol, only definite and probable SUDEP were included in the calculation.|||17.79|0.60|
70898829|NCT00101933|141285966|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||Fisher Exact|||Fisher's Exact test. The numbers presented in this analysis are the number of subjects who were responders based on a responder definition including all subjects with 50% or greater improvement in total seizure count.||||0.830
70898830|NCT00101933|141285967|SUPERIORITY_OR_OTHER|||||||0.105||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.105
70898831|NCT00101933|141285968|SUPERIORITY_OR_OTHER|||||||0.498||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.498
70898832|NCT00101933|141285969|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
70898833|NCT00101933|141285970|SUPERIORITY_OR_OTHER|||||||0.0387||95.0||||Since a visit-by-treatment interaction did not remain in the final model, the results shown are for the entire blinded phase.|Generalized Estimating Equations|This analysis is adjusted for significant baseline covariates.||The numbers presented are the percentage reduction in the number of seizures in each group. A negative percentage change indicates a seizure reduction.||||0.0387
70898834|NCT00101933|141285971|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Wilcoxon (Mann-Whitney)|||Numbers provided indicate the percentage change from baseline in seizure frequency of each participant's most severe seizures. Negative values indicate improvement from baseline.||||0.047
70898835|NCT01218126|141285997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6||||0.517|TWO_SIDED|95.0|-10.4|5.2|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 4.||5.2|-10.4|0.517
70898836|NCT01218126|141285997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.763|TWO_SIDED|95.0|-8.9|6.5|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 4||6.5|-8.9|0.763
70898837|NCT01218126|141285997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.5||||0.164|TWO_SIDED|95.0|-2.3|13.3|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 4||13.3|-2.3|0.164
70898838|NCT01218126|141285997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.9|TWO_SIDED|95.0|-9.2|10.5|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 12||10.5|-9.2|0.900
70898839|NCT01218126|141285997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.788|TWO_SIDED|95.0|-11.1|8.4|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 12||8.4|-11.1|0.788
70898840|NCT01218126|141285997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8||||0.722|TWO_SIDED|95.0|-8.2|11.8|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 12||11.8|-8.2|0.722
70898841|NCT01218126|141285997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.7||||0.26|TWO_SIDED|95.0|-18.2|4.9|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 24||4.9|-18.2|0.260
70898842|NCT01218126|141285997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7||||0.422|TWO_SIDED|95.0|-16.1|6.8|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 24||6.8|-16.1|0.422
70898843|NCT01218126|141285997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.4||||0.564|TWO_SIDED|95.0|-15.1|8.2|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 24||8.2|-15.1|0.564
70898844|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.968|TWO_SIDED|95.0|-39.0|38.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 4||38|-39|0.968
70898845|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.0||||0.715|TWO_SIDED|95.0|-45.0|31.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 Placebo versus Losmapimod 7.5 mg at Week 4||31|-45|0.715
70898846|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.0||||0.152|TWO_SIDED|95.0|-10.0|66.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 4||66|-10|0.152
70898847|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.922|TWO_SIDED|95.0|-45.0|40.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 8||40|-45|0.922
70898848|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.0||||0.694|TWO_SIDED|95.0|-34.0|50.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 8||50|-34|0.694
70898849|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.0||||0.094|TWO_SIDED|95.0|-6.3|79.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 8||79|-6.3|0.094
70898850|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.0||||0.456|TWO_SIDED|95.0|-26.0|58.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 12||58|-26|0.456
70898851|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.0||||0.355|TWO_SIDED|95.0|-22.0|61.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 12||61|-22|0.355
70898852|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|49.0||||0.023|TWO_SIDED|95.0|6.7|91.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 12||91|6.7|0.023
70898853|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.0||||0.32|TWO_SIDED|95.0|-21.0|65.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 16||65|-21|0.320
70898854|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.0||||0.267|TWO_SIDED|95.0|-19.0|67.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 16||67|-19|0.267
70898855|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.0||||0.289|TWO_SIDED|95.0|-20.0|67.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 16||67|-20|0.289
70898856|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.0||||0.786|TWO_SIDED|95.0|-37.0|49.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 20||49|-37|0.786
70898857|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|33.0||||0.134|TWO_SIDED|95.0|-10.0|76.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 20||76|-10|0.134
70898858|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|29.0||||0.191|TWO_SIDED|95.0|-15.0|74.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 20||74|-15|0.191
70898859|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.0||||0.852|TWO_SIDED|95.0|-38.0|46.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 24||46|-38|0.852
70898860|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.0||||0.397|TWO_SIDED|95.0|-24.0|60.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 24||60|-24|0.397
70898861|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.0||||0.494|TWO_SIDED|95.0|-28.0|58.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 24||58|-28|0.494
70898862|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.0||||0.807|TWO_SIDED|95.0|-31.0|40.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 4||40|-31|0.807
70898863|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.0||||0.386|TWO_SIDED|95.0|-20.0|51.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 4||51|-20|0.386
70898864|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|31.0||||0.089|TWO_SIDED|95.0|-4.8|67.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 4||67|-4.8|0.089
70898865|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.958|TWO_SIDED|95.0|-45.0|43.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 8||43|-45|0.958
70898866|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.0||||0.766|TWO_SIDED|95.0|-37.0|50.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 8||50|-37|0.766
70898867|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|43.0||||0.06||95.0|-1.7|87.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 8||87|-1.7|0.060
70898868|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.0||||0.678|TWO_SIDED|95.0|-53.0|35.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 12||35|-53|0.678
70898869|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.0||||0.636|TWO_SIDED|95.0|-33.0|54.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 12||54|-33|0.636
70898870|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|38.0||||0.094|TWO_SIDED|95.0|-6.5|83.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 12||83|-6.5|0.094
70898871|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.0||||0.772|TWO_SIDED|95.0|-49.0|37.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 16||37|-49|0.772
70898872|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.0||||0.387|TWO_SIDED|95.0|-24.0|61.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 16||61|-24|0.387
70898873|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|26.0||||0.243|TWO_SIDED|95.0|-18.0|69.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 16||69|-18|0.243
70898874|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.0||||0.398|TWO_SIDED|95.0|-62.0|25.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 20||25|-62|0.398
70898875|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.0||||0.214|TWO_SIDED|95.0|-16.0|70.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 20||70|-16|0.214
70898876|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.0||||0.526|TWO_SIDED|95.0|-30.0|58.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 20||58|-30|0.526
70898877|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.0||||0.671|TWO_SIDED|95.0|-53.0|34.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 24||34|-53|0.671
70898878|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.0||||0.355|TWO_SIDED|95.0|-23.0|64.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 24||64|-23|0.355
70898879|NCT01218126|141285998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.0||||0.781|TWO_SIDED|95.0|-38.0|50.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 24||50|-38|0.781
70898880|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.0||||0.742|TWO_SIDED|95.0|-66.0|93.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 4||93|-66|0.742
70898881|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-30.0||||0.446|TWO_SIDED|95.0|-109.0|48.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 4||48|-109|0.446
70898882|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|57.0||||0.157|TWO_SIDED|95.0|-22.0|137.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 4||137|-22|0.157
70898883|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.0||||0.826|TWO_SIDED|95.0|-93.0|74.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 8||74|-93|0.826
70898884|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.0||||0.773||95.0|-95.0|70.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 8||70|-95|0.773
70898885|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|47.0||||0.277|TWO_SIDED|95.0|-38.0|131.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 8||131|-38|0.277
70898886|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|45.0||||0.319|TWO_SIDED|95.0|-43.0|132.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 12||132|-43|0.319
70898887|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.0||||0.716|TWO_SIDED|95.0|-71.0|103.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 12||103|-71|0.716
70898888|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|75.0||||0.098|TWO_SIDED|95.0|-14.0|163.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 12||163|-14|0.098
70898889|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.0||||0.832|TWO_SIDED|95.0|-80.0|100.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 16||100|-80|0.832
70898890|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|25.0||||0.579|TWO_SIDED|95.0|-64.0|114.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 16||114|-64|0.579
70898891|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|42.0||||0.369|TWO_SIDED|95.0|-49.0|133.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 16||133|-49|0.369
70898892|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-32.0||||0.487|TWO_SIDED|95.0|-121.0|58.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 20||58|-121|0.487
70898893|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.0||||0.887|TWO_SIDED|95.0|-82.0|95.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 20||95|-82|0.887
70898894|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|32.0||||0.486|TWO_SIDED|95.0|-59.0|123.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 20||123|-59|0.486
70898895|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.0||||0.604||95.0|-113.0|66.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 24||66|-113|0.604
70898896|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.0||||0.872|TWO_SIDED|95.0|-97.0|82.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 24||82|-97|0.872
70898897|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|43.0||||0.355|TWO_SIDED|95.0|-48.0|134.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 24||134|-48|0.355
70898898|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.0||||0.839|TWO_SIDED|95.0|-65.0|80.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 4||80|-65|0.839
70898899|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.0||||0.741|TWO_SIDED|95.0|-60.0|84.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 4||84|-60|0.741
70898900|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|71.0||||0.056|TWO_SIDED|95.0|-1.8|143.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 4||143|-1.8|0.056
70898901|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-25.0||||0.554|TWO_SIDED|95.0|-107.0|57.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 8||57|-107|0.554
70898902|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-30.0||||0.472|TWO_SIDED|95.0|-110.0|51.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 8||51|-110|0.472
70898903|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|66.0||||0.116|TWO_SIDED|95.0|-16.0|149.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 8||149|-16|0.116
70898904|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.0||||0.805|TWO_SIDED|95.0|-98.0|76.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 12||76|-98|0.805
70898905|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.0||||0.763|TWO_SIDED|95.0|-73.0|100.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 12||100|-73|0.763
70898906|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|75.0||||0.096|TWO_SIDED|95.0|-13.0|163.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 12||163|-13|0.096
70898907|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-31.0||||0.485|TWO_SIDED|95.0|-118.0|56.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 16||56|-118|0.485
70898908|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.0||||0.704|TWO_SIDED|95.0|-69.0|103.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 16||103|-69|0.704
70898909|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|72.0||||0.108|TWO_SIDED|95.0|-16.0|159.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 16||159|-16|0.108
70898910|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-64.0||||0.147||95.0|-151.0|23.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 20||23|-151|0.147
70898911|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.0||||0.792|TWO_SIDED|95.0|-98.0|75.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 20||75|-98|0.792
70898912|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.0||||0.275||95.0|-39.0|138.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 20||138|-39|0.275
70898913|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.0||||0.53|TWO_SIDED|95.0|-115.0|59.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 24||59|-115|0.530
70898914|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.0||||0.827|TWO_SIDED|95.0|-77.0|96.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 24||96|-77|0.827
70898915|NCT01218126|141285999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|35.0||||0.434|TWO_SIDED|95.0|-53.0|124.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 24||124|-53|0.434
70898916|NCT01218126|141286000|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.686|TWO_SIDED|95.0|-3.3|2.2|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 12||2.2|-3.3|0.686
70898917|NCT01218126|141286000|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5||||0.279|TWO_SIDED|95.0|-1.2|4.2|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 12||4.2|-1.2|0.279
70898918|NCT01218126|141286000|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8||||0.193|TWO_SIDED|95.0|-4.6|0.9|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 12||0.9|-4.6|0.193
70898919|NCT01218126|141286000|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.803|TWO_SIDED|95.0|-2.7|3.5|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 24||3.5|-2.7|0.803
70898920|NCT01218126|141286000|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9||||0.229|TWO_SIDED|95.0|-1.2|5.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 24||5.0|-1.2|0.229
70898921|NCT01218126|141286000|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4||||0.39|TWO_SIDED|95.0|-4.5|1.8|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 24||1.8|-4.5|0.390
70898922|NCT01218126|141286002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.96||||0.157|TWO_SIDED|95.0|0.91|1.01|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 4||1.01|0.91|0.157
70898923|NCT01218126|141286002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.91||||0|TWO_SIDED|95.0|0.86|0.95|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 4||0.95|0.86|0.000
70898924|NCT01218126|141286002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.91||||0|TWO_SIDED|95.0|0.86|0.96|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 4||0.96|0.86|0.000
70898925|NCT01218126|141286002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.95||||0.072||95.0|0.9|1.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 8||1.00|0.90|0.072
70898926|NCT01218126|141286002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9||||0|TWO_SIDED|95.0|0.85|0.95|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 8||0.95|0.85|0.000
70898927|NCT01218126|141286002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.88||||0|TWO_SIDED|95.0|0.83|0.94|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 8||0.94|0.83|0.000
70898928|NCT01218126|141286002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.99||||0.728|TWO_SIDED|95.0|0.93|1.05|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 12||1.05|0.93|0.728
70898929|NCT01218126|141286002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.91||||0.002|TWO_SIDED|95.0|0.86|0.97|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 12||0.97|0.86|0.002
70898930|NCT01218126|141286002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9||||0.001|TWO_SIDED|95.0|0.84|0.95|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 12||0.95|0.84|0.001
70898931|NCT01218126|141286002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.01||||0.823|TWO_SIDED|95.0|0.95|1.07|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 24||1.07|0.95|0.823
70898932|NCT01218126|141286002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.96||||0.153|TWO_SIDED|95.0|0.9|1.02|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 24||1.02|0.90|0.153
70898933|NCT01218126|141286002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.95||||0.126|TWO_SIDED|95.0|0.9|1.01|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 24||1.01|0.90|0.126
70898934|NCT01218126|141286003|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.87||||0.291|TWO_SIDED|95.0|0.68|1.12|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 4||1.12|0.68|0.291
70898935|NCT01218126|141286003|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.78||||0.046|TWO_SIDED|95.0|0.61|1.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 4||1.00|0.61|0.046
70898936|NCT01218126|141286003|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.73||||0.014|TWO_SIDED|95.0|0.57|0.94|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 4||0.94|0.57|0.014
70898937|NCT01218126|141286003|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.04||||0.755|TWO_SIDED|95.0|0.82|1.32|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 8||1.32|0.82|0.755
70898938|NCT01218126|141286003|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77||||0.029|TWO_SIDED|95.0|0.6|0.97|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 8||0.97|0.60|0.029
70898939|NCT01218126|141286003|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74||||0.015|TWO_SIDED|95.0|0.58|0.94|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 8||0.94|0.58|0.015
70898940|NCT01218126|141286003|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.91||||0.468|TWO_SIDED|95.0|0.71|1.17|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 12||1.17|0.71|0.468
70898941|NCT01218126|141286003|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.73||||0.011||95.0|0.57|0.93|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 12||0.93|0.57|0.011
70898942|NCT01218126|141286003|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.64||||0|TWO_SIDED|95.0|0.5|0.82|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 12||0.82|0.50|0.000
70898943|NCT01218126|141286003|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.95||||0.696|TWO_SIDED|95.0|0.74|1.22|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 24||1.22|0.74|0.696
70898944|NCT01218126|141286003|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.81||||0.099|TWO_SIDED|95.0|0.64|1.04|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 24||1.04|0.64|0.099
70898945|NCT01218126|141286003|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.86||||0.256|TWO_SIDED|95.0|0.67|1.11|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 24||1.11|0.67|0.256
70898946|NCT01218126|141286004|SUPERIORITY_OR_OTHER||Rate ratio|1.0||||0.989|TWO_SIDED|95.0|0.64|1.54|||Negative Binomial regression model|Covariates of treatment, group, smoking status, history of exacerbations and region, with logarithm of time on treatment as an offset variable.|Rate ratio= (Rate of exacerbation in Losmapimod 2.5 mg arm) / (Rate of exacerbation in placebo arm)|Losmapimod 2.5 mg versus Placebo||1.54|0.64|0.989
70898947|NCT01218126|141286004|SUPERIORITY_OR_OTHER||Rate ratio|0.98||||0.915||95.0|0.64|1.5|||Negative Binomial regression model|Covariates of treatment, group, smoking status, history of exacerbations and region, with logarithm of time on treatment as an offset variable.|Rate ratio= (Rate of exacerbation in Losmapimod 7.5 mg arm) / (Rate of exacerbation in placebo arm)|Placebo versus Losmapimod 7.5 mg||1.50|0.64|0.915
70898948|NCT01218126|141286004|SUPERIORITY_OR_OTHER||Rate ratio|0.74||||0.21|TWO_SIDED|95.0|0.47|1.18|||Negative Binomial regression model|Covariates of treatment, group, smoking status, history of exacerbations and region, with logarithm of time on treatment as an offset variable.|Rate ratio= (Rate of exacerbation in Losmapimod 15 mg arm) / (Rate of exacerbation in placebo arm)|Placebo versus Losmapimod 15 mg||1.18|0.47|0.210
70898949|NCT01860703|141286006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.01|||||TWO_SIDED|90.0|1.02|5.01||||||||5.01|1.02|
70898950|NCT01860703|141286012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.23|||||TWO_SIDED|90.0|3.26|7.19||||||||7.19|3.26|
70898951|NCT01860703|141286015|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|13.42|||||TWO_SIDED|90.0|11.1|15.75||||||||15.75|11.10|
70898952|NCT00251862|141286030|SUPERIORITY_OR_OTHER||Absolute Difference|8.3||||0.046|TWO_SIDED|95.0|-2.2|14.2|||Chi-squared|||Sample size and power considerations focused on a two-group comparison of the DA alone versus control study arms for the primary outcome of colorectal cancer (CRC) screening test completion at 12 months. Based on crude estimates of baseline test completion rates, we calculated that a target sample of 275 subjects per arm provided greater than 80% power of detecting a 54% vs. 40% difference at the P\<0.05 level.||14.2|-2.2|0.046
70898953|NCT00251862|141286030|SUPERIORITY_OR_OTHER||Absolute Difference|6.0||||0.153|TWO_SIDED|95.0|0.2|16.5|||Chi-squared|||||16.5|0.2|0.153
70898954|NCT00251862|141286031|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons: DA+YDR vs. Control, P\<0.001; DA alone vs. Control, P\<0.001|ANCOVA|||The three study groups were compared on cumulative pre-test and post-test knowledge through separate one-factor analysis of covariance (ANCOVA); followed pairwise comparisons using Bonferroni's adjusted multiple comparison procedure.||||<0.001
70898955|NCT00251862|141286032|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||The three study groups were compared through separate one-factor analysis of covariance (ANCOVA); followed pairwise comparisons using Bonferroni's adjusted multiple comparison procedure.||||<0.001
70898956|NCT00251862|141286033|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||The three study groups were compared through separate one-factor analysis of covariance (ANCOVA); followed pairwise comparisons using Bonferroni's adjusted multiple comparison procedure.||||<0.001
70898957|NCT02134587|141286035|SUPERIORITY_OR_OTHER_LEGACY|||||||1e-05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.00001
70898958|NCT02134587|141286036|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
70898959|NCT00416182|141286040|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED|95.0||||P-value of \< 0.05 is considered significant|t-test, 2 sided|||||||0.2
70898960|NCT00416182|141286041|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED|95.0||||P-value of \< 0.05 is considered significant.|t-test, 2 sided|||||||0.048
70898961|NCT00416182|141286042|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|95.0||||P-value \< 0.05 is considered significant|t-test, 2 sided|||||||0.003
70898962|NCT00416182|141286043|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED|||||P \<0.05 is considered significant|t-test, 2 sided|||||||0.4
70898963|NCT02532179|141286069|SUPERIORITY||Mean Ratio|3.0|||<|0.001|TWO_SIDED|95.0|2.09|4.29||Null hypothesis: there is no difference in immune modulation over time|Mixed Models Analysis|||||4.29|2.09|<0.001
70898964|NCT02532179|141286070|SUPERIORITY||Mean Ratio|3.82|||<|0.001|TWO_SIDED|95.0|2.77|5.25||Null hypothesis: there is no difference in immune modulation over time|Mixed Models Analysis|||||5.25|2.77|<0.001
70898965|NCT02532179|141286071|SUPERIORITY||Mean Ratio|6.55|||<|0.001|TWO_SIDED|95.0|3.87|11.06||Null hypothesis: there is no difference in immune modulation over time|Mixed Models Analysis|||||11.06|3.87|<0.001
70898966|NCT00789815|141286093|NON_INFERIORITY_OR_EQUIVALENCE|A preliminary study was performed to determine the sample size before this trial. 15 and 15 patients undergoing FB received BIS-guided propofol sedation and clinical-judged midazolam sedation, respectively. The incidences of hypoxemia were 0.33 and 0.20, respectively. The selected sample size of 225 in each group will yield 90% power for detecting a clinically meaningful difference of 0.13 at the 5.0% level of significance. To allow for 10% missing data, we recruited 250 patients per group.||||||0.05||95.0|||||Chi-squared|||"The null hypothesis: the incidence of hypoxemia occured during FB with BIS-guided propofol infusion is higher than that with clinical-judged midazolam administration.~Power calculation is described below."||||0.05
70898967|NCT00789815|141286094|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||The null hypothesis: the incidence of hypotension during FB in patients of study group is higher than that in the control group.||||0.05
70898968|NCT00789815|141286095|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||||||0.05
70898969|NCT00789815|141286096|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||||||0.05
70898970|NCT00789815|141286097|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||||||0.05
70898971|NCT00789815|141286098|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Wilcoxon (Mann-Whitney)|||The null hypothesis: the global tolerance of patients in study is worse than that in the control group.||||0.05
70898972|NCT00789815|141286099|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||||||0.05
70898973|NCT00789815|141286100|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||||||0.05
70898974|NCT02673398|141286108|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.05|TWO_SIDED|95.0|-0.82|0.01|||t-test, 2 sided||Patients with higher risk scores were more likely to require a dose reduction. The lack of significance is most likely due to the small sample size.|Student's t-test was used to assess if geriatric risk score differed depending on whether or not a participant had a dose reduction (mean difference log2 risk = no dose modification - dose modification).||0.01|-0.82|0.05
70898975|NCT02673398|141286108|SUPERIORITY||Slope|-1.29|STANDARD_ERROR_OF_MEAN|1.44||0.39|TWO_SIDED||||||Regression, Linear|||Linear regression was used to assess whether log2 geriatric toxicity risk score was a risk factor for the number of course completed.||||0.39
70898976|NCT02673398|141286109|SUPERIORITY||Slope|-0.093|STANDARD_ERROR_OF_MEAN|0.0398||0.03|TWO_SIDED||||||Regression, Linear||The older the participant the lower the steady state value.|Least squares regression was used to assess the relationship between steady state neratinib concentration and age||||0.03
70898977|NCT02673398|141286109|SUPERIORITY||Slope|1.4|STANDARD_DEVIATION|2.39||0.57|TWO_SIDED||||||Regression, Linear||Geriatric risk score was not predictive of steady state concentration.|Least squares regression was used to determine if geriatric toxicity risk score at baseline was predictive of steady state neratinib concentration.||||0.57
70898978|NCT01321554|141286110|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.21|||||TWO_SIDED|99.0|0.14|0.31||||||||0.31|0.14|
70898979|NCT04098406|141286135|SUPERIORITY||Mean Difference (Final Values)|7.7||||0.4304|TWO_SIDED|95.0|-11.9|27.3|||MMRM|||||27.3|-11.9|0.4304
70898980|NCT04098406|141286136|SUPERIORITY||Mean Difference (Final Values)|3.6||||0.6519|TWO_SIDED|95.0|-12.4|19.7|||MMRM|||||19.7|-12.4|0.6519
70898981|NCT04098406|141286137|SUPERIORITY||Mean Difference (Final Values)|18.8||||0.6158|TWO_SIDED|95.0|-56.4|94.0|||MMRM|||||94.0|-56.4|0.6158
70898982|NCT04098406|141286142|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.4249|TWO_SIDED|95.0|-1.6|3.6|||MMRM|||||3.6|-1.6|0.4249
70898983|NCT04098406|141286143|SUPERIORITY|||||||0.035|||||||Chi-squared|||||||0.0350
70898984|NCT04098406|141286145|SUPERIORITY||Mean Difference (Final Values)|9.1||||0.2237|TWO_SIDED|95.0|-5.8|23.9|||ANCOVA|||||23.9|-5.8|0.2237
70898985|NCT04098406|141286146|SUPERIORITY||Hazard Ratio (HR)|0.29||||0.0125|TWO_SIDED|95.0|0.103|0.815|||Log Rank|||||0.815|0.103|0.0125
70898986|NCT04098406|141286148|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.0177|TWO_SIDED|95.0|0.2|1.6|||MMRM|||||1.6|0.2|0.0177
70898987|NCT01783418|141286162|SUPERIORITY_OR_OTHER|||||||0.613|TWO_SIDED||||||ANOVA|||Baseline and Post-intervention (8 weeks)||||0.613
70898988|NCT01783418|141286163|SUPERIORITY_OR_OTHER|||||||0.957|TWO_SIDED||||||ANOVA|||Baseline, Post-intervention (8 weeks)||||0.957
70898989|NCT01783418|141286164|SUPERIORITY_OR_OTHER|||||||0.256|TWO_SIDED||||||ANOVA|||Baseline, Post-intervention (8 weeks)||||.256
70898990|NCT01783418|141286165|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||ANOVA|||Baseline, Post-intervention (8 weeks)||||0.97
70898991|NCT01783418|141286166|SUPERIORITY_OR_OTHER|||||||0.241|TWO_SIDED||||||ANOVA|||Baseline, Post-intervention||||0.241
70898992|NCT01783418|141286167|SUPERIORITY_OR_OTHER|||||||0.358|TWO_SIDED||||||ANOVA|||Baseline, Post-intervention (8 weeks)||||0.358
70898993|NCT01783418|141286168|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||ANOVA|||Baseline, Post-intervention (8 weeks)||||0.95
70898994|NCT04791761|141286169|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||Null hypothesis: No difference in average pain scores before medication between opioid and non-opioid groups.||||0.8
70898995|NCT04791761|141286169|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference in average pain scores after medication between opioid and non-opioid groups.||||0.7
70898996|NCT04791761|141286170|SUPERIORITY|||||||0.2|||||||Fisher Exact|||Null hypothesis: There will be no difference in the proportion of patients visiting the emergency department or urgent care post-operatively between opioid and non-opioid groups.||||0.2
70898997|NCT00415610|141286219|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||The repeated measure analysis of the hourly average SBP was calculated with and without adjusting for baseline NIHSS and age.|repeated measure|Adjusted for initial deficit severity of using baseline NIHSS instead of GCS to better discriminate among patients with GCS score \> 8.||The hourly average (of maximum and minimum) SBP measurements were graphed with box-and-whiskers plot. In addition, a repeated measures analysis of the 25 average SBP (baseline and subsequent 24 hourly measures) was conducted with a mixed effects model (assuming autoregressive covariance structure in SAS version 9.1 PROC MIXED) to determine statistically the effect of treatment intensity (tier) on the average SBP over the 24 hrs with and without adjustment for baseline NIHSS score and age.||||< 0.01
70898998|NCT00415610|141286220|SUPERIORITY_OR_OTHER||||||<|0.5|TWO_SIDED|||||Observed average SBP change at 2 hrs after treatment initiation between subjects who did or did not have neurologic deterioration within 24 hrs.|Wilcoxon rank sum test|Mean decrease measured for subjects with neurological deterioration and subjects without neurological deterioration.||Done as a surrogate to evaluate the relationship between early SBP reduction and safety events.||||< .5
70898999|NCT01113502|141286325|OTHER||Maximum Tolerated Dose (mg)|300.0|||||TWO_SIDED|||||||||||||
70899000|NCT00995501|141286331|SUPERIORITY||Odds Ratio (OR)|0.96||||0.86|TWO_SIDED|99.6|0.45|2.0|||Regression, Logistic|||Compare 4 arms with intensive glucose control vs. 4 arms with conventional glucose control||2|0.45|0.86
70899001|NCT00995501|141286331|SUPERIORITY||Odds Ratio (OR)|0.96||||0.87|TWO_SIDED|99.6|0.45|2.0|||Regression, Logistic|||Compare 4 arms with Dexamethasone vs. 4 arms with Placebo||2|0.45|0.87
70899002|NCT00995501|141286331|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9|TWO_SIDED|99.6|0.49|2.2|||Regression, Logistic|||Compare 4 arms with light anesthesia vs. 4 arms with deep anesthesia||2.2|0.49|0.90
70899003|NCT00995501|141286332|SUPERIORITY||Odds Ratio (OR)|0.92||||0.8|TWO_SIDED|99.6|0.37|2.3|||Regression, Logistic|||Compare 4 arms with intensive glucose control vs. 4 arms with conventional glucose control||2.3|0.37|0.8
70899004|NCT00995501|141286332|SUPERIORITY||Odds Ratio (OR)|1.1||||0.84|TWO_SIDED|99.6|0.43|2.7|||Regression, Logistic|||Compare 4 arms with Dexamethasone vs. 4 arms with Placebo||2.7|0.43|0.84
70899005|NCT00995501|141286332|SUPERIORITY||Odds Ratio (OR)|1.1||||0.87|TWO_SIDED|99.6|0.42|2.7|||Regression, Logistic|||||2.7|0.42|0.87
70899006|NCT02227875|141286338|NON_INFERIORITY|Mixed-Effect Model for Repeated Measures|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.098|0.218||||||||0.218|-0.098|
70899007|NCT02657317|141286359|SUPERIORITY||Mean Difference (Final Values)|-9.1||||0.001|TWO_SIDED|95.0|-14.4|-3.7|||GLMM|||To detect a medium effect (d = 0.50) at 2-sided α = 0.05, 50 participants were needed in each study arm (total N = 100). We anticipated 30% attrition in each arm. Data for the primary aim were analyzed using generalized linear mixed models adjusting for baseline levels of prognostic variable and using random intercepts at the level of participants. The primary analysis was based on intent-to-treat.||-3.7|-14.4|.001
70899008|NCT03786952|141286360|SUPERIORITY|||||||0.453|||||||ANOVA|||||||0.453
70899009|NCT03786952|141286361|SUPERIORITY|||||||0.931|||||||ANOVA|||||||0.931
70899010|NCT03786952|141286362|SUPERIORITY|||||||0.923|||||||ANOVA|||||||0.923
70899011|NCT03786952|141286363|SUPERIORITY|||||||0.399|||||||ANOVA|||||||0.399
70899012|NCT03786952|141286364|SUPERIORITY|||||||0.872|||||||ANOVA|||||||0.872
70899013|NCT03786952|141286365|SUPERIORITY|||||||0.998|||||||ANOVA|||||||0.998
70899014|NCT03786952|141286366|SUPERIORITY|||||||0.1|||||||ANOVA|||||||0.10
70899015|NCT03786952|141286367|SUPERIORITY|||||||0.992|||||||ANOVA|||||||0.992
70899016|NCT03786952|141286368|SUPERIORITY|||||||0.519|||||||ANOVA|||||||0.519
70899017|NCT03786952|141286369|SUPERIORITY|||||||0.007|||||||ANOVA|||||||0.007
70899018|NCT03786952|141286370|SUPERIORITY|||||||0.457|||||||ANOVA|||||||0.457
70899019|NCT03786952|141286371|SUPERIORITY|||||||0.415|||||||ANOVA|||||||0.415
70899020|NCT03786952|141286372|SUPERIORITY|||||||0.923|||||||ANOVA|||||||0.923
70899021|NCT03786952|141286373|SUPERIORITY|||||||0.981|||||||ANOVA|||||||0.981
70899022|NCT03786952|141286374|SUPERIORITY|||||||0.627|||||||ANOVA|||||||0.627
70899023|NCT03786952|141286375|SUPERIORITY|||||||0.901|||||||ANOVA|||||||0.901
70899024|NCT03786952|141286376|SUPERIORITY|||||||0.166|||||||ANOVA|||||||0.166
70899025|NCT03786952|141286377|SUPERIORITY|||||||0.252|||||||ANOVA|||||||0.252
70899026|NCT01800968|141286394|SUPERIORITY_OR_OTHER|||||||0.3087|||||||Rank score|||||||0.3087
70899027|NCT01800968|141286395|SUPERIORITY_OR_OTHER|||||||0.1549|||||||Regression, Linear|||||||0.1549
70899028|NCT01800968|141286396|SUPERIORITY_OR_OTHER|||||||0.1932|||||||Regression, Linear|||||||0.1932
70899029|NCT01800968|141286397|SUPERIORITY_OR_OTHER|||||||0.9535|||||||Regression, Linear|||||||0.9535
70899030|NCT01800968|141286398|SUPERIORITY_OR_OTHER|||||||0.8548|||||||Regression, Linear|||||||0.8548
70899031|NCT01800968|141286399|SUPERIORITY_OR_OTHER|||||||0.4266|||||||Regression, Linear|||||||0.4266
70899032|NCT01800968|141286400|SUPERIORITY_OR_OTHER|||||||0.1705|||||||Regression, Linear|||||||0.1705
70899033|NCT01800968|141286401|SUPERIORITY_OR_OTHER|||||||0.1309|||||||Regression, Linear|||||||0.1309
70899034|NCT01800968|141286402|SUPERIORITY_OR_OTHER|||||||0.792|||||||Regression, Linear|||||||0.7920
70899035|NCT01800968|141286403|SUPERIORITY_OR_OTHER|||||||0.7026|||||||Regression, Linear|||||||0.7026
70899036|NCT01800968|141286404|SUPERIORITY_OR_OTHER|||||||0.2662|||||||Regression, Linear|||||||0.2662
70899037|NCT01800968|141286405|SUPERIORITY_OR_OTHER|||||||0.6395|||||||Regression, Linear|||||||0.6395
70899038|NCT01800968|141286406|SUPERIORITY_OR_OTHER|||||||0.8218|||||||Regression, Linear|||||||0.8218
70899039|NCT01800968|141286407|SUPERIORITY_OR_OTHER|||||||0.1124|||||||Regression, Linear|||||||0.1124
70899040|NCT01800968|141286408|SUPERIORITY_OR_OTHER|||||||0.8088|||||||Regression, Linear|||||||0.8088
70899041|NCT01800968|141286409|SUPERIORITY_OR_OTHER|||||||0.7764|||||||Log Rank|||||||0.7764
70899042|NCT01800968|141286410|SUPERIORITY_OR_OTHER|||||||0.1701|||||||Log Rank|||||||0.1701
70899043|NCT01800968|141286411|SUPERIORITY_OR_OTHER|||||||0.6532|||||||Regression, Linear|||||||0.6532
70899044|NCT01800968|141286412|SUPERIORITY_OR_OTHER|||||||0.2033|||||||Rank score|||||||0.2033
70899045|NCT03266770|141286434|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.83|TWO_SIDED|95.0|-1.07|1.29|||t-test, 2 sided|||||1.29|-1.07|0.83
70899046|NCT02220894|141286436|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0003|TWO_SIDED|95.0|0.58|0.86||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), and histology (squamous vs. non-squamous).|||0.86|0.58|0.0003
70899047|NCT02220894|141286437|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0012|TWO_SIDED|95.0|0.65|0.91||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).|||0.91|0.65|0.0012
70899048|NCT02220894|141286438|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0013|TWO_SIDED|95.0|0.71|0.93||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).|||0.93|0.71|0.0013
70899049|NCT02220894|141286439|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.026|TWO_SIDED|95.0|0.69|1.0||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. non-squamous).|||1.00|0.69|0.0260
70899050|NCT02220894|141286440|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.2134|TWO_SIDED|95.0|0.8|1.1||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).|||1.10|0.80|0.2134
70899051|NCT02220894|141286441|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7964|TWO_SIDED|95.0|0.93|1.19||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).|||1.19|0.93|0.7964
70899052|NCT02220894|141286442|SUPERIORITY||Difference in Percentage (DP)|7.0||||0.0353|TWO_SIDED|95.0|-0.6|14.6||One-sided p-value for testing. H0: difference in percentages=0 vs. H1: difference in percentages \>0|Stratified Miettinen and Nurminen||DP for pembrolizumab vs. chemotherapy based on Miettinen \& Nurminen method stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous).|||14.6|-0.6|0.0353
70899053|NCT02220894|141286443|SUPERIORITY||Difference in Percentage (DP)|4.6||||0.0744|TWO_SIDED|95.0|-1.7|10.9||One-sided p-value for testing. H0: difference in percentages=0 vs. H1: difference in percentages \>0|Stratified Miettinen and Nurminen||DP for pembrolizumab vs. chemotherapy based on Miettinen \& Nurminen method stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).|||10.9|-1.7|0.0744
70899054|NCT02220894|141286444|SUPERIORITY||Difference in Percentage (DP)|0.6||||0.406|TWO_SIDED|95.0|-4.2|5.4||One-sided p-value for testing. H0: difference in percentages=0 vs. H1: difference in percentages \>0|Stratified Miettinen and Nurminen||DP for pembrolizumab vs. chemotherapy based on Miettinen \& Nurminen method stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).|||5.4|-4.2|0.4060
70899055|NCT05007392|141286447|SUPERIORITY||Difference of percentage|35.87|||<|0.001|TWO_SIDED|95.0|27.36|44.37|||Cochran-Mantel-Haenszel|P value based on a Cochran-Mantel-Haenszel test stratified by baseline SUA level and baseline body mass index (BMI) level.|The difference of percentage and stratified 95 percent (%) confidence interval (CI) was based on Mantel-Haenszel method.|||44.37|27.36|<0.001
70899056|NCT05007392|141286448|NON_INFERIORITY|The prespecified non-inferiority margin was -10% in the analysis.|Difference of percentage|5.24|||||TWO_SIDED|95.0|-3.69|14.17|||||The difference of percentage and stratified 95% CI was based on Mantel-Haenszel method.|||14.17|-3.69|
70899057|NCT02453685|141286453|SUPERIORITY_OR_OTHER||Treatment difference at week 32|0.18||||0.0435|TWO_SIDED|95.0|0.01|0.36|||Mixed Models Analysis||"'Treatment difference' refers to BIAsp 30 minus Basal-bolus"|Analysis was performed using mixed model repeated measurements including treatment, region, and strata as fixed effects, HbA1c at baseline as covariate, interactions between all fixed effects and visit and using an unstructured residual covariance matrix.||0.36|0.01|0.0435
70899058|NCT01338025|141286537|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Log Rank|||||||0.03
70899059|NCT03017079|141286542|NON_INFERIORITY|a:0.05;β：0.01 P=.046||||||0.05|||||||t-test, 2 sided|||P=.046||||0.05
70899060|NCT03017079|141286543|NON_INFERIORITY|a 0.05|Odds Ratio (OR)|0.05||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
70899061|NCT03017079|141286544|SUPERIORITY|||||||0.05|||||||Chi-squared, Corrected|||||||0.05
70899062|NCT03017079|141286546|NON_INFERIORITY|According to the rule of a=0.05, P\<0.05 means that the hypothesis was true|||||<|0.05|||||||Chi-squared, Corrected|||||||<0.05
70899063|NCT01165775|141286581|SUPERIORITY_OR_OTHER|||||||0.2155|||||||Chi-squared|||||||0.2155
70899064|NCT01077830|141286612|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.33|||||TWO_SIDED|95.0|0.84|2.09|||Regression, Cox||Hazard Ratio obtained by dividing the crude rate of death (any cause) reported in the Ezetimibe/Simvastatin 10/40 arm by the crude rate of death (any cause) in the Placebo arm|||2.09|0.84|
70899065|NCT01077830|141286613|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.36|||||TWO_SIDED|95.0|0.3|6.06|||||Hazard Ratio obtained by dividing the crude rate of death from cancer reported in the Ezetimibe/Simvastatin 10/40 arm by the crude rate of death from cancer in the Placebo arm|||6.06|0.30|
70899066|NCT01077830|141286614|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.55|||||TWO_SIDED|95.0|0.27|1.11|||||Hazard Ratio obtained by dividing the crude rate of new cancers reported in the Ezetimibe/Simvastatin 10/40 arm by the crude rate of newly diagnosed cancers in the the Placebo arm|||1.11|0.27|
70899067|NCT01194570|141286617|SUPERIORITY_OR_OTHER_LEGACY||Relative Reduction (%)|29.337||||0.0404|TWO_SIDED|95.0|-1.618|51.456||P-value from a ranked ANCOVA on Percent Change from BL adjusting for rank of BL 25-Foot Timed Walk (25-FTW), Geographical Region (US vs ROW) and Age (\<=45, \> 45 years); missing observations imputed with LOCF.|Ranked ANCOVA||Relative reduction was calculated as -Relative change = - (Ocrelizumab response-Placebo response)/Placebo response\*100%. The 95% CI for relative reduction was obtained using the Bootstrap method.|Estimates (back-transformed) based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix: log(Post-baseline(BL)/BL) = log(BL 25-FTW) + Geographical Region (US vs. ROW) + Age (\<=45, \> 45 years) + Week + Treatment + Treatment\*Week (repeated values over Week) + log (BL 25-FTW)\*Week. Relative reduction was calculated as -Relative change = -(OCR response-Placebo response)/Placebo response\*100%. The 95% CI for relative reduction was obtained using the Bootstrap method.||51.456|-1.618|0.0404
70899068|NCT01194570|141286618|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Geometric Means|0.9|||<|0.0001|TWO_SIDED|95.0|0.876|0.924||P-value is from ranked ANCOVA on Percent Change from BL adjusting for rank of BL T2 lesion volume, Geographical Region (US vs ROW) and Age (\<=45, \> 45 years); missing observations imputed with LOCF.|Ranked ANCOVA|||Estimates (back-transformed) are based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix: log(Post-BL/BL) = log(BL T2 lesion volume) + Geographical Region (US vs. ROW) + Age (\<=45, \> 45 years) + Week + Treatment + Treatment\*Week (repeated values over Week) + log (BL T2 lesion volume)\*Week.||0.924|0.876|< 0.0001
70899069|NCT01194570|141286619|SUPERIORITY_OR_OTHER_LEGACY||Relative Reduction (%)|17.475||||0.0206|TWO_SIDED|95.0|3.206|29.251|||MMRM||Relative reduction was calculated as -Relative change = - (Ocrelizumab response-Placebo response)/Placebo response\*100%. The 95% CI for relative reduction was obtained using the Bootstrap method.|Estimates are from analysis based on MMRM using unstructured covariance matrix: Percentage Change = Brain Volume at Week 24 + Geographical Region (US vs. ROW) + Age (\<=45, \> 45 years) + Week + Treatment + Treatment\*Week (repeated values over Week) + Brain Volume at Week 24\*Week. Relative reduction was calculated as - Relative change = - (OCR response-Placebo response)/Placebo response\*100%. The 95% CI for relative reduction was obtained using Bootstrap method.||29.251|3.206|0.0206
70899070|NCT01194570|141286620|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|0.377|STANDARD_ERROR_OF_MEAN|0.725||0.6034|TWO_SIDED|95.0|-1.048|1.802|||MMRM||Difference in adjusted mean was calculated as Ocrelizumab SF-36 Physical Component Summary Score - Placebo SF-36 Physical Component Summary Score.|Estimates are from analysis based on MMRM using unstructured covariance matrix: Change = Baseline PCS Score + Geographical Region (US vs. ROW) + Age (\<=45, \> 45 years) + Week + Treatment + Treatment\*Week (repeated values over Week) + Baseline PCS Score\*Week.||1.802|-1.048|0.6034
70899071|NCT01337674|141286623|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Met versus PBO + Met is \<20 mmHg|Mean Difference (Final Values)|-1.22|||||TWO_SIDED|90.0|-8.42|5.98|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Semi-recumbent, Day 1||5.98|-8.42|
70899072|NCT01337674|141286623|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Met versus PBO + Met is \<20 mmHg|Mean Difference (Final Values)|2.29|||||TWO_SIDED|90.0|-4.92|9.49|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Semi-recumbent, Day 7||9.49|-4.92|
70899073|NCT01337674|141286623|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Met versus PBO + Met is \<20 mmHg|Mean Difference (Final Values)|1.65|||||TWO_SIDED|90.0|-5.31|8.62|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Standing, Day 1||8.62|-5.31|
70899074|NCT01337674|141286623|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Met versus PBO + Met is \<20 mmHg|Mean Difference (Final Values)|-1.09|||||TWO_SIDED|90.0|-8.06|5.88|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Standing, Day 7||5.88|-8.06|
70899075|NCT01337674|141286624|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Amlo versus PBO + Amlo is \<20 mmHg|Mean Difference (Final Values)|1.95|||||TWO_SIDED|90.0|-2.85|6.75|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Semi-recumbent, Day 1||6.75|-2.85|
70899076|NCT01337674|141286624|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Amlo versus PBO + Amlo is \<20 mmHg|Mean Difference (Final Values)|-5.91|||||TWO_SIDED|90.0|-10.71|-1.11|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Semi-recumbent, Day 7||-1.11|-10.71|
70899077|NCT01337674|141286624|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Amlo versus PBO + Amlo is \<20 mmHg|Mean Difference (Final Values)|-6.25|||||TWO_SIDED|90.0|-11.47|-1.03|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Standing, Day 1||-1.03|-11.47|
70899078|NCT01337674|141286624|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Amlo versus PBO + Amlo is \<20 mmHg|Mean Difference (Final Values)|-1.57|||||TWO_SIDED|90.0|-6.79|3.65|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Standing, Day 7||3.65|-6.79|
70899079|NCT01224925|141286640|SUPERIORITY||Log Rank (Mantel-Cox)|842.0|||<|0.01|TWO_SIDED|95.0|693.0|991.0|||Log Rank|||The power calculation was based on the intention to show a 30% difference in success rates. The following parameters were used (binomial scale): type I error: 5%; expected success rate in the CH group: 55% (based on Barthel et al. 2000); minimal difference between success rates not to be overlooked: 30%; type II error: 5%. The calculations revealed the need for 64 subjects in each group. After adding 20% for eventual drop-outs, we planned to recruit 160 subjects in one year.||991|693|<0.01
70899080|NCT01224925|141286640|SUPERIORITY||Log Rank (Mantel-Cox)|1201.0|||<|0.01|TWO_SIDED|95.0|1068.0|1335.0|||Log Rank|||||1335|1068|<0.01
70899081|NCT01224925|141286641|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||>0.05
70899082|NCT02178059|141286642|NON_INFERIORITY_OR_EQUIVALENCE|Approximately 34 healthy volunteers will be entered into the study in order to complete 30 evaluable volunteers. Based on the study SD-001-0268, a residual intra-individual standard deviation of 0.300/sqrt(2) = 0.212 can be expected on the natural log scale. With 30 completed volunteers there will be a 93% chance that the upper limits of two-sided 90% CI for Cmax and AUC ratios are \<1.25 provided that the true mean ratios are \<1.05.|Ratio of geometric means (%)|88.2|||||TWO_SIDED|90.0|81.03|96.02|||||Comparison of Bricanyl Turbuhaler M3 (test) to Bricanyl Turbuhaler M2 (reference)|No increase in the exposure of plasma terbutaline after administration of Bricanyl Turbuhaler M3 will be concluded if the upper bound of the 90% CIs for the ratios of AUC and Cmax are both below 1.25||96.02|81.03|
70899083|NCT02178059|141286643|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.8052|TWO_SIDED|90.0|-0.17|0.17|||Wilcoxon signed rank test|||||0.17|-0.17|0.8052
70899084|NCT02178059|141286647|NON_INFERIORITY_OR_EQUIVALENCE|Approximately 34 healthy volunteers will be entered into the study in order to complete 30 evaluable volunteers. Based on the study SD-001-0268, a residual intra-individual standard deviation of 0.300/sqrt(2) = 0.212 can be expected on the natural log scale. With 30 completed volunteers there will be a 93% chance that the upper limits of two-sided 90% CI for Cmax and AUC ratios are \<1.25 provided that the true mean ratios are \<1.05.|Ratio of geometric means (%)|91.44|||||TWO_SIDED|90.0|84.82|98.58|||||Comparison of Bricanyl Turbuhaler M3 (test) to Bricanyl Turbuhaler M2 (reference)|No increase in the exposure of plasma terbutaline after administration of Bricanyl Turbuhaler M3 will be concluded if the upper bound of the 90% CIs for the ratios of AUC and Cmax are both below 1.25||98.58|84.82|
70899085|NCT03092375|141286666|OTHER|Study is not intended to be powered|Mean Difference (Final Values)|-0.76|||||TWO_SIDED|95.0|-9.48|5.12|||||Excludes re-infection and death|The difference in the percentage of subjects with on-treatment virologic failure (Defined as increase of \>1 log10 IU/mL above nadir during treatment, or HCV RNA \>= 15 IU/mL at end of treatment with at least 6 weeks of treatment between Arms A and B are summarized with two-sided 95% Wilson score intervals.||5.12|-9.48|
70899086|NCT03092375|141286667|OTHER|The difference in the percentage of subjects with post-treatment relapse between Arms A and B are summarized with two-sided 95% Wilson score intervals.|Mean Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-10.49|5.49||||||||5.49|-10.49|
70899087|NCT03092375|141286668|OTHER|Difference in percentage of subjects with on-treatment virologic failure between Arms C and D will be summarized with two-sided 95% Wilson score intervals|Mean Difference (Final Values)|9.52|||||TWO_SIDED|95.0|-3.03|22.08||||||||22.08|-3.03|
70899088|NCT03092375|141286669|OTHER||Mean Difference (Final Values)|-1.81|||||TWO_SIDED|95.0|-13.85|10.22||||||Excludes re-infection and death||10.22|-13.85|
70899089|NCT03092375|141286670|OTHER|Study was not powered to compare efficacy|Logistic Regression Contrast Estimate|-0.812||||0.161|TWO_SIDED|95.0|-1.947|0.323|||Chi-squared|Logistic regression contrast estimates with Wald confidence intervals and Chi-square p values|Comparison of Arm Pair A/C versus B/D overall on mITT population|||0.323|-1.947|0.161
70899090|NCT03092375|141286670|OTHER|Study is not powered to compare efficacy of 12 wks vs 16 weeks of treatment|Logistic regression contrast estimate|0.89||||0.89|TWO_SIDED|95.0|-1.239|1.076|||Chi-squared|Logistic regression contrast estimates with Wald confidence intervals and Chi-square p values|Difference in proportion of SVR12 rates for 12 vs 16 weeks on mITT Comparing Cirrhotic subjects versus non-cirrhotic subjects.|||1.076|-1.239|0.890
70899091|NCT03092375|141286670|OTHER|Study is not powered|Logistic regression contrast estimate|0.977||||0.265|TWO_SIDED|95.0|-0.74|2.694|||Chi-squared|||Comparison of 12 weeks vs 16 weeks in Genotype 1b vs non-1b||2.694|-0.740|0.265
70899092|NCT02293395|141286693|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.584|TWO_SIDED|95.0|0.8|1.5|||Log Rank|||||1.5|0.8|0.584
70899093|NCT01023568|141286694|NON_INFERIORITY_OR_EQUIVALENCE|The GlideScope and Truview PCD video laryngoscopes were individually assessed for non-inferiority on time to intubation vs direct laryngoscopy at the 0.025 significance level using an a priori specified non-inferiority delta of seven seconds (about 40% of the expected standard deviation of 18 sec and not thought to be clinically important).|Median Difference (Final Values)|14.0|||>|0.99|TWO_SIDED|95.0|7.0|26.0|||Wilcoxon (Mann-Whitney)||Glidescope - direct laryngoscopy|||26|7|>0.99
70899094|NCT01023568|141286694|NON_INFERIORITY_OR_EQUIVALENCE|The GlideScope and Truview PCD video laryngoscopes were individually assessed for non-inferiority on time to intubation vs direct laryngoscopy at the 0.025 significance level using an a priori specified non-inferiority delta of seven seconds (about 40% of the expected standard deviation of 18 sec and not thought to be clinically important).|Median Difference (Final Values)|17.0|||>|0.99|TWO_SIDED|95.0|6.0|28.0|||Wilcoxon (Mann-Whitney)||Truview PCD - direct laryngoscopy|||28|6|>0.99
70899095|NCT01023568|141286695|SUPERIORITY_OR_OTHER|||||||0.28|||||||ANOVA|||||||0.28
70899096|NCT01023568|141286696|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.0|||>|0.99|TWO_SIDED|95.0|1.0|2.0|||Wilcoxon (Mann-Whitney)|1-tailed Wilcoxon sum-rank test|"The median difference was Hodges-Lehmann estimation and the confidence intervals were exact confidence limits. The SAS NPAR1WAY procedure was used for test and estimation."|The Cormack-Lehane grade with a grade 1 (best grade) to 4 (worst grade) was analyzed as an ordinal outcome.||2|1|> 0.99
70899097|NCT01023568|141286696|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.18|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|1-tailed Wilcoxon sum-rank test|"The median difference was Hodges-Lehmann estimation and the confidence intervals were exact confidence limits. The SAS NPAR1WAY procedure was used for test and estimation."|The Cormack-Lehane grade with a grade 1 (best grade) to 4 (worst grade) was analyzed as an ordinal outcome.||0|0|0.18
70899098|NCT01023568|141286697|SUPERIORITY_OR_OTHER|||||||0.26|||||||ANOVA|||||||0.26
70899099|NCT01023568|141286698|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Chi-squared|||||||>0.99
70899100|NCT00224770|141286699|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.3|STANDARD_ERROR_OF_MEAN|6.6||0.324|ONE_SIDED|95.0||16.2|||Fisher Exact|One-sided test|MISTIE rate=14.8, 95% upper limit=25.1; medical rate=9.5, 95% upper limit=20.5; comparison considers MISTIE rate minus medical rate.|Null hypothesis is that rate of mortality within 30 days is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher rate of mortality than the medical arm.||16.2||0.324
70899101|NCT00224770|141286699|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.4|STANDARD_ERROR_OF_MEAN|8.2||0.633|ONE_SIDED|95.0||11.2|||Fisher Exact|One-sided test|ICES rate=7.1, 95% upper limit=29.7; medical rate=9.5, 95% upper limit=20.5; comparison considers ICES rate minus medical rate.|Null hypothesis is that rate of mortality within 30 days is the same between the two groups. The alternative hypothesis tests whether ICES surgical management has a higher rate of mortality than the medical arm.||11.2||0.633
70899102|NCT00224770|141286700|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.6|STANDARD_ERROR_OF_MEAN|3.1||0.174|ONE_SIDED|95.0||11.7|||Fisher Exact|One-sided test|MISTIE rate=5.6, 95% upper limit=13.7; medical rate=0.0, 95% upper limit=6.9; comparison considers MISTIE rate minus medical rate.|Null hypothesis is that rate of procedure-related mortality within 7 days is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher rate of procedure-related mortality than the medical arm.||11.7||0.174
70899103|NCT00224770|141286701|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.4|STANDARD_ERROR_OF_MEAN|2.4||0.437|ONE_SIDED|95.0||1.5|||Fisher Exact|One-sided test|MISTIE rate=0.0, 95% upper limit=5.4; medical rate=2.4, 95% upper limit=10.8; comparison considers MISTIE rate minus medical rate.|Null hypothesis is that rate of cerebritis, meningitis and ventriculitis within 30 days is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher rate of these infections than medical.||1.5||0.437
70899104|NCT00224770|141286701|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.4|STANDARD_ERROR_OF_MEAN|2.4||0.75|ONE_SIDED|95.0||1.5|||Fisher Exact|One-sided test|ICES rate=0.0, 95% upper limit=19.3; medical rate=2.4, 95% upper limit=10.8; comparison considers ICES rate minus medical rate.|Null hypothesis is that rate of cerebritis, meningitis and ventriculitis within 30 days is the same between the two groups. The alternative hypothesis tests whether ICES surgical management has a higher rate of these infections than medical.||1.5||0.750
70899105|NCT00224770|141286702|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.2|STANDARD_ERROR_OF_MEAN|3.9||0.409|ONE_SIDED|95.0||9.6|||Fisher Exact|One-sided test|MISTIE rate=5.6, 95% upper limit=13.7; medical rate=2.4, 95% upper limit=10.8; comparison considers MISTIE rate minus medical rate|Null hypothesis is that rate of symptomatic rebleeding 72 hours post last dose is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher rate of symptomatic rebleeding than the medical arm.||9.6||0.409
70899106|NCT00224770|141286702|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.4|STANDARD_ERROR_OF_MEAN|2.4||0.75|ONE_SIDED|95.0||2.2|||Fisher Exact|One-sided test|ICES rate=0.0, 95% upper limit=19.3; medical rate=2.4, 95% upper limit=10.8; comparison considers ICES rate minus medical rate|Null hypothesis is that rate of symptomatic rebleeding 72 hours post last dose is the same between the two groups. The alternative hypothesis tests whether ICES surgical management has a higher rate of symptomatic rebleeding than the medical arm.||2.2||0.750
70899107|NCT00224770|141286703|SUPERIORITY_OR_OTHER|||||||0.468|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of the mRS values for both groups are the same. The alternative hypothesis is that the distributions are not the same.||||0.468
70899108|NCT00224770|141286703|SUPERIORITY_OR_OTHER|||||||0.294|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of the mRS values for both groups are the same. The alternative hypothesis is that the distributions are not the same.||||0.294
70899109|NCT00224770|141286704|SUPERIORITY_OR_OTHER|||||||0.395|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of the mRS values for both groups are the same. The alternative hypothesis is that the distributions are not the same.||||0.395
70899110|NCT00224770|141286704|SUPERIORITY_OR_OTHER|||||||0.175|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of the mRS values for both groups are the same. The alternative hypothesis is that the distributions are not the same.||||0.175
70899111|NCT00224770|141286705|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of percentage of blood clot resolved are the same between the two groups. The alternative hypothesis is that the distributions are not the same.||||<0.0001
70899112|NCT00224770|141286705|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of percentage of blood clot resolved are the same between the two groups. The alternative hypothesis is that the distributions are not the same.||||<0.0001
70899113|NCT00224770|141286706|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Sign test|Two-sided test||Null hypothesis is that the median percent resolved is 0. The alternative hypothesis is that the median percent resolved is not equal to 0.||||<0.0001
70899114|NCT00224770|141286706|SUPERIORITY_OR_OTHER|||||||0.791|TWO_SIDED||||||Sign test|Two-sided||Null hypothesis is that the median percent resolved is 0. The alternative hypothesis is that the median percent resolved is not equal to 0.||||0.791
70899115|NCT00224770|141286707|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.9|STANDARD_ERROR_OF_MEAN|9.5||0.189|ONE_SIDED|95.0||26.6|||Fisher Exact|One-sided test|MISTIE rate=34.6, 95% upper limit=46.9; medical rate=23.7, 95% upper limit=37.7; comparison considers MISTIE rate minus medical rate.|Null hypothesis is that the proportion with mRS score of 0-3 at 180 days is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher proportion than the medical arm.||26.6||0.189
70899116|NCT00224770|141286707|SUPERIORITY_OR_OTHER||Risk Difference (RD)|19.2|STANDARD_ERROR_OF_MEAN|14.9||0.156|ONE_SIDED|95.0||43.7|||Fisher Exact|One-sided test|ICES rate=42.9, 95% upper limit=67.5; medical rate=23.7, 95% upper limit=37.7; comparison considers ICES rate minus medical rate.|Null hypothesis is that the proportion with mRS score of 0-3 at 180 days is the same between the two groups. The alternative hypothesis tests whether ICES surgical management has a higher proportion than the medical arm.||43.7||0.156
70899117|NCT00861614|141286708|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0127|TWO_SIDED|95.0|0.71|0.96|||Log Rank||Ipilimumab over placebo|||0.96|0.71|0.0127
70899118|NCT00861614|141286710|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.61|0.82|||||Ipilimumab over placebo|||0.82|0.61|
70899119|NCT00861614|141286712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.25|||||TWO_SIDED|95.0|0.02|4.0|||||Ipilimumab over placebo|||4.00|0.02|
70899120|NCT01255592|141286730|SUPERIORITY_OR_OTHER||Ratio of AZD5069 80 mg to placebo|0.31||||0.004|TWO_SIDED|90.0|0.17|0.59|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection, and baseline as covariates. The analysis was done on log-transformed data. The results were back-transformed after the analysis on the log scale.||0.59|0.17|0.004
70899121|NCT01255592|141286731|SUPERIORITY_OR_OTHER||Ratio of AZD5069 80 mg to placebo|0.64||||0.008|TWO_SIDED|90.0|0.49|0.84|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection, and baseline as covariates. The analysis was done on log-transformed data. The results were back-transformed after the analysis on the log scale.||0.84|0.49|0.008
70899122|NCT01255592|141286732|SUPERIORITY_OR_OTHER||LS mean difference|6.78|STANDARD_ERROR_OF_MEAN|3.298||0.047|TWO_SIDED|90.0|1.22|12.33|||ANCOVA|||The 24-hour sputum weight on Visit 4 was compared between groups using ANCOVA (additive model) with treatment and inhaled corticosteroids/P. aeruginosa infection as fixed effects and baseline as a covariate.||12.33|1.22|0.047
70899123|NCT01255592|141286733|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.092||0.284|TWO_SIDED|90.0|-0.05|0.26|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.26|-0.05|0.284
70899124|NCT01255592|141286734|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.078||0.929|TWO_SIDED|90.0|-0.12|0.14|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.14|-0.12|0.929
70899125|NCT01255592|141286735|SUPERIORITY_OR_OTHER||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.062||0.966|TWO_SIDED|90.0|-0.11|0.1|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.10|-0.11|0.966
70899126|NCT01255592|141286736|SUPERIORITY_OR_OTHER||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.09||0.791|TWO_SIDED|90.0|-0.13|0.17|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.17|-0.13|0.791
70899127|NCT01255592|141286737|SUPERIORITY_OR_OTHER||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.7||0.433|TWO_SIDED|90.0|-1.6|0.6|||ANCOVA|||The ANCOVA model used TDI as the response variable with treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and BDI as covariates.||0.6|-1.6|0.433
70899128|NCT01255592|141286738|SUPERIORITY_OR_OTHER||LS mean difference|0.7|STANDARD_ERROR_OF_MEAN|8.03||0.935|TWO_SIDED|90.0|-12.81|14.13|||ANCOVA|||Morning PEF: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||14.13|-12.81|0.935
70899129|NCT01255592|141286738|SUPERIORITY_OR_OTHER||LS mean difference|3.3|STANDARD_ERROR_OF_MEAN|7.35||0.654|TWO_SIDED|90.0|-9.02|15.64|||ANCOVA|||Evening PEF: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||15.64|-9.02|0.654
70899130|NCT01255592|141286739|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.329|TWO_SIDED|90.0|-0.09|0.36|||ANCOVA|||Describe your breathing: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.36|-0.09|0.329
70899131|NCT01255592|141286739|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.664|TWO_SIDED|90.0|-0.16|0.27|||ANCOVA|||How often do you cough?: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.27|-0.16|0.664
70899132|NCT01255592|141286739|SUPERIORITY_OR_OTHER||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.17||0.152|TWO_SIDED|90.0|-0.04|0.54|||ANCOVA|||Night time symptom score: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.54|-0.04|0.152
70899133|NCT01255592|141286739|SUPERIORITY_OR_OTHER||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.25||0.15|TWO_SIDED|90.0|-0.8|0.05|||ANCOVA|||What color is your sputum?: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.05|-0.80|0.150
70899134|NCT01255592|141286739|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.248|TWO_SIDED|90.0|-0.06|0.35|||ANCOVA|||The amount of sputum you produced: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.35|-0.06|0.248
70899135|NCT01255592|141286739|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.053|TWO_SIDED|90.0|-0.45|-0.04|||ANCOVA|||Type of sputum: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||-0.04|-0.45|0.053
70899136|NCT01255592|141286739|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.14||0.179|TWO_SIDED|90.0|-0.04|0.42|||ANCOVA|||How do you feel?: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.42|-0.04|0.179
70899137|NCT01255592|141286739|SUPERIORITY_OR_OTHER||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.43||0.942|TWO_SIDED|90.0|-0.75|0.68|||ANCOVA|||Number of puffs of inhalers: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.68|-0.75|0.942
70899138|NCT01255592|141286740|SUPERIORITY_OR_OTHER||LS mean difference|-1.66|STANDARD_ERROR_OF_MEAN|3.374||0.625|TWO_SIDED|90.0|-7.32|4.0|||ANCOVA|||Total score: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||4.00|-7.32|0.625
70899139|NCT01255592|141286740|SUPERIORITY_OR_OTHER||LS mean difference|-4.88|STANDARD_ERROR_OF_MEAN|3.342||0.151|TWO_SIDED|90.0|-10.49|0.74|||ANCOVA|||Symptom domain: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.74|-10.49|0.151
70899140|NCT01255592|141286740|SUPERIORITY_OR_OTHER||LS mean difference|-1.31|STANDARD_ERROR_OF_MEAN|4.524||0.773|TWO_SIDED|90.0|-8.91|6.28|||ANCOVA|||Activity domain: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||6.28|-8.91|0.773
70899141|NCT01255592|141286740|SUPERIORITY_OR_OTHER||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|3.845||0.92|TWO_SIDED|90.0|-6.84|6.07|||ANCOVA|||Impact domain: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||6.07|-6.84|0.920
70899142|NCT01255592|141286741|SUPERIORITY_OR_OTHER||Ratio of LS means|0.69||||0.22|TWO_SIDED|90.0|0.42|1.14|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.14|0.42|0.220
70899143|NCT01255592|141286742|SUPERIORITY_OR_OTHER||Ratio of LS means|4.46|||<|0.001|TWO_SIDED|90.0|3.05|6.54|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||6.54|3.05|<0.001
70899144|NCT01255592|141286743|SUPERIORITY_OR_OTHER||Ratio of LS means|0.92||||0.67|TWO_SIDED|90.0|0.68|1.26|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.26|0.68|0.670
70899145|NCT01255592|141286744|SUPERIORITY_OR_OTHER||Ratio of LS means|0.99||||0.968|TWO_SIDED|90.0|0.78|1.27|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.27|0.78|0.968
70899146|NCT01255592|141286745|SUPERIORITY_OR_OTHER||Ratio of LS means|1.43||||0.193|TWO_SIDED|90.0|0.91|2.24|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||2.24|0.91|0.193
70899147|NCT01255592|141286746|SUPERIORITY_OR_OTHER||Ratio of LS means|3.24|||<|0.001|TWO_SIDED|90.0|2.19|4.79|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||4.79|2.19|<0.001
70899148|NCT01255592|141286747|SUPERIORITY_OR_OTHER||Ratio of LS means|1.02||||0.917|TWO_SIDED|90.0|0.71|1.48|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.48|0.71|0.917
70899149|NCT01255592|141286748|SUPERIORITY_OR_OTHER||Ratio of LS means|0.17||||0.111|TWO_SIDED|90.0|0.03|1.08|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.08|0.03|0.111
70899150|NCT01255592|141286749|SUPERIORITY_OR_OTHER||Ratio of LS means|1.33||||0.367|TWO_SIDED|90.0|0.79|2.26|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||2.26|0.79|0.367
70899151|NCT01255592|141286750|SUPERIORITY_OR_OTHER||Ratio of LS means|1.54||||0.112|TWO_SIDED|90.0|0.98|2.4|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||2.40|0.98|0.112
70899152|NCT01255592|141286751|SUPERIORITY_OR_OTHER||Ratio of LS means|1.05||||0.241|TWO_SIDED|90.0|0.98|1.12|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.12|0.98|0.241
70899153|NCT01255592|141286752|SUPERIORITY_OR_OTHER||Ratio of LS means|5.5|||<|0.001|TWO_SIDED|90.0|4.18|7.23|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||7.23|4.18|<0.001
70899154|NCT01255592|141286753|SUPERIORITY_OR_OTHER||Ratio of LS means|1.16||||0.281|TWO_SIDED|90.0|0.92|1.47|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.47|0.92|0.281
70899155|NCT01255592|141286754|SUPERIORITY_OR_OTHER||Ratio of LS means|1.56||||0.001|TWO_SIDED|90.0|1.28|1.91|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.91|1.28|0.001
70899156|NCT01255592|141286755|SUPERIORITY_OR_OTHER||Ratio of LS means|6.07|||<|0.001|TWO_SIDED|90.0|4.42|8.35|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||8.35|4.42|<0.001
70899157|NCT00838682|141286766|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
70899158|NCT00838682|141286767|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
70899159|NCT00838682|141286768|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
70899160|NCT00838682|141286769|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
70899161|NCT00838682|141286770|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
70899162|NCT00838682|141286771|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
70899163|NCT03675451|141286782|OTHER|Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.|Proportion of Participants|0.95|||||TWO_SIDED|95.0|0.74|0.99|||||Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.|Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.||0.99|0.74|
70899164|NCT03675451|141286783|OTHER|Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.|Proportion of Participants|1.0|||||TWO_SIDED|95.0|0.66|1.0|||||Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.|Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.||1.00|0.66|
70899165|NCT03315143|141286808|SUPERIORITY||Hazard Ratio (HR)|0.74|||<|0.001|TWO_SIDED|95.0|0.63|0.88|||Cox proportional hazards model|||The estimates of the hazard ratio (HR) and corresponding 2-sided 95% confidence interval (CI) was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-cardiovascular (non-CV) death treated as a competing event.||0.88|0.63|<0.001
70899166|NCT03315143|141286809|SUPERIORITY||Hazard Ratio (HR)|0.67|||<|0.001|TWO_SIDED|95.0|0.55|0.82|||Cox proportional hazards model|||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.82|0.55|<0.001
70899167|NCT03315143|141286810|SUPERIORITY||Hazard Ratio (HR)|0.9|||=|0.35|TWO_SIDED|95.0|0.73|1.12|||Cox proportional hazards model|||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||1.12|0.73|=0.35
70899168|NCT03315143|141286811|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.63|0.83||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.83|0.63|
70899169|NCT03315143|141286812|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.65|0.89||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.89|0.65|
70899170|NCT03315143|141286813|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.46|1.08||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||1.08|0.46|
70899171|NCT03315143|141286814|SUPERIORITY||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.83|1.18||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction.||1.18|0.83|
70899172|NCT03315143|141286815|SUPERIORITY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.65|0.91||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.91|0.65|
70899173|NCT04067401|141286843|SUPERIORITY||Effect size|-0.13||||0.062|TWO_SIDED|95.0|-0.29|0.01|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||.01|-.29|.062
70899174|NCT04067401|141286844|SUPERIORITY||Effect size|-0.23||||0.001|TWO_SIDED|95.0|-0.39|-0.09|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||-.09|-.39|.001
70899175|NCT04067401|141286845|SUPERIORITY||Effect size|-0.16||||0.027|TWO_SIDED|95.0|-0.34|-0.02|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||-.02|-.34|.027
70899176|NCT04067401|141286846|SUPERIORITY||Effect size|-0.24||||0.002|TWO_SIDED|95.0|-0.41|-0.08|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||-.08|-.41|.002
70899177|NCT04067401|141286847|SUPERIORITY||Effect size|0.01||||0.821|TWO_SIDED|95.0|-0.12|0.11|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||.11|-.12|.821
70899178|NCT04067401|141286848|SUPERIORITY||Effect size|-0.14||||0.024|TWO_SIDED|95.0|-0.31|-0.02|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||-.02|-.31|.024
70899179|NCT04067401|141286849|SUPERIORITY||Effect size|0.18||||0.012|TWO_SIDED|95.0|0.04|0.29|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||.29|.04|.012
70899180|NCT04067401|141286850|SUPERIORITY||Effect size|0.21||||0.01|TWO_SIDED|95.0|0.05|0.35||Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component|Mixed Models Analysis|||||.35|.05|.010
70899181|NCT01446666|141286881|SUPERIORITY||||||<|0.01|||||||McNemar|||The HCC detection rate was defined as the number of patients with HCC detected by a given modality divided by the total number of patients with HCC detected by all modalities and by follow-up dynamic CT scan. The HCC detection rates from ultrasonography and MRI were compared.||||<0.01
70899182|NCT01446666|141286882|SUPERIORITY||||||<|0.01|||||||McNemar|||||||<0.01
70899183|NCT01446666|141286883|SUPERIORITY||||||<|0.01|||||||McNemar|||||||<0.01
70899184|NCT01446666|141286884|SUPERIORITY|||||||0.004|||||||McNemar|||||||0.004
70899185|NCT01814748|141286889|SUPERIORITY_OR_OTHER||Difference in least squares means|0.12||||0.535|TWO_SIDED|95.0|-0.26|0.49|||Constrained longitudinal data analysis|Terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups.||||0.49|-0.26|0.535
70899186|NCT01814748|141286890|SUPERIORITY_OR_OTHER||Difference in percent|-0.4|||||TWO_SIDED|95.0|-13.8|13.0||||||||13.0|-13.8|
70899187|NCT01814748|141286891|SUPERIORITY_OR_OTHER||Difference in percent|-2.0||||||||||||||||||
70899188|NCT01814748|141286892|SUPERIORITY_OR_OTHER||Difference in least squares means|4.2||||0.685|TWO_SIDED|95.0|-16.1|24.4|||Constrained longitudinal data analysis|Terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups.||||24.4|-16.1|0.685
70899189|NCT01814748|141286893|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.7||||0.586|TWO_SIDED|95.0|-17.1|9.7|||Constrained longitudinal data analysis|Terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups.||||9.7|-17.1|0.586
70899190|NCT01814748|141286894|SUPERIORITY_OR_OTHER||Between-group rate difference|-0.4|||||TWO_SIDED|95.0|-14.0|13.1|||Mietinnen and Nurminen|||||13.1|-14.0|
70899191|NCT01814748|141286895|SUPERIORITY_OR_OTHER||Between-group rate difference|4.0|||||TWO_SIDED|95.0|-7.4|15.5|||Mietinnen and Nurminen|||||15.5|-7.4|
70899192|NCT01972529|141286901|SUPERIORITY||Difference of proportion vs placebo|42.6|||<|0.0001|TWO_SIDED|95.0|27.2|58.1|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the elective procedure within each baseline platelet count cohort.|Difference of proportion versus (vs) placebo = proportion of Responders for avatrombopag - proportion of Responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the 60 mg avatrombopag and matched placebo treatment groups.||58.1|27.2|<0.0001
70899193|NCT01972529|141286901|SUPERIORITY||Difference of proportion vs placebo|49.9|||<|0.0001|TWO_SIDED|95.0|31.6|68.2|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the elective procedure within each baseline platelet count cohort.|Difference of proportion vs placebo = proportion of Responders for avatrombopag - proportion of Responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the avatrombopag and placebo treatment groups.||68.2|31.6|<0.0001
70899194|NCT01972529|141286902|SUPERIORITY||Difference of proportion vs placebo|64.7|||<|0.0001|TWO_SIDED|95.0|53.6|75.8|||Cochran-Mantel-Haenszel|P-value is stratified by the risk of bleeding associated with the elective procedure within each baseline platelet count cohort.|Difference of proportion vs placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the avatrombopag and placebo treatment groups||75.8|53.6|<0.0001
70899195|NCT01972529|141286902|SUPERIORITY||Difference of percentage vs placebo|67.5|||<|0.0001|TWO_SIDED|95.0|51.6|83.4|||Cochran-Mantel-Haenszel|P-value is stratified by the risk of bleeding associated with the elective procedure within each baseline platelet count cohort.|Difference of proportion vs placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the avatrombopag and placebo treatment groups||83.4|51.6|<0.0001
70899196|NCT01972529|141286903|SUPERIORITY||Difference in change of platelet count|27.5|||<|0.0001|TWO_SIDED|95.0|22.5|32.5|||Wilcoxon (Mann-Whitney)|P-value is based on Wilcoxon rank sum test for each avatrombopag treatment group vs placebo within each baseline platelet count cohort.|Difference in change from baseline of platelet count for avatrombopag vs placebo within each baseline platelet count cohort is based on Hodges-Lehmann estimation; 95% confidence interval is the asymptotic (Moses) CI.|||32.5|22.5|<0.0001
70899197|NCT01972529|141286903|SUPERIORITY||Difference in change of platelet count|33.0|||<|0.0001|TWO_SIDED|95.0|25.5|41.5|||Wilcoxon (Mann-Whitney)|P-value is based on Wilcoxon rank sum test for each avatrombopag treatment group vs placebo within each baseline platelet count cohort.|Difference in change from baseline of platelet count for avatrombopag vs placebo within each baseline platelet count cohort is based on Hodges-Lehmann estimation; 95% confidence interval is the asymptotic (Moses) CI.|||41.5|25.5|<0.0001
70899198|NCT02274857|141286906|SUPERIORITY|||||||0.2179|||||||Chi-squared|||||||0.2179
70899199|NCT02274857|141286907|SUPERIORITY|||||||0.2782|||||||Chi-squared|||||||0.2782
70899200|NCT02274857|141286908|SUPERIORITY|||||||0.7266|||||||Chi-squared|||||||0.7266
70899201|NCT02274857|141286909|SUPERIORITY|||||||0.3522|||||||Chi-squared|||||||0.3522
70899202|NCT00939874|141286913|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
70899203|NCT00330174|141286915|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED|95.0|||||Mixed Models Analysis|||Drinking outcomes were analyzed using multiple linear regression, controlling for site and baseline drinking level. Drinking and psychiatric symptoms assessed over time were examined using repeated measures (intercept only) mixed linear models (PROC MIXED in SAS). Analyses were performed using SAS statistical software (version 9.2; SAS Institute, Inc., Cary, NC). All tests were two-tailed and p-values less than 0.05 were considered statistically significant.||||0.64
70899204|NCT00118716|141286945|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.0|STANDARD_ERROR_OF_MEAN|1.29||0.021|TWO_SIDED|95.0|0.5|5.6||LS Mean Difference, SE, CI, and p-value were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA||LS Mean Diff was calculated as FSC 100/50mcg BID-FP 100mcg BID.|FSC 100/50mcg BID versus FP 100mcg BID for maximal percent change in FEV1 following exercise challenge at Week 4.||5.6|0.5|0.021
70899205|NCT00118716|141286946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41|STANDARD_ERROR_OF_MEAN|0.085|<|0.001|TWO_SIDED|95.0|0.24|0.58||LS Mean Diff, SE, CI, and p-value were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA||LS Mean Diff was calculated as FSC 100/50mcg BID-FP 100mcg BID.|FSC 100/50mcg BID versus FP 100mcg BID for post-dose FEV1 AUC Day 1.||0.58|0.24|<0.001
70899206|NCT00118716|141286947|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.1|STANDARD_ERROR_OF_MEAN|4.83||0.097|TWO_SIDED|95.0|-1.5|17.6||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA||LS Mean Diffs were calculated as FSC 100/50mcg BID-FP 100mcg BID.|FSC 100/50mcg BID versus FP 100mcg BID for AM PEF||17.6|-1.5|0.097
70899207|NCT00118716|141286948|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.7|STANDARD_ERROR_OF_MEAN|4.3||0.396|TWO_SIDED|95.0|-4.8|12.1||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA||LS Mean Diffs were calculated as FSC 100/50mcg BID-FP 100mcg BID.|FSC 100/50mcg BID versus FP 100mcg BID PM PEF.||12.1|-4.8|0.396
70899208|NCT00118716|141286951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.129||0.168|TWO_SIDED|95.0|-0.08|0.43||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for activity limitation at Week 2||0.43|-0.08|0.168
70899209|NCT00118716|141286951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.147||0.465|TWO_SIDED|95.0|-0.18|0.4||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for activity limitation at Week 4.||0.40|-0.18|0.465
70899210|NCT00118716|141286951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.133||0.222|TWO_SIDED|95.0|-0.1|0.42||LS Mean Diff, SE, CI, and p-values are from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for activity limitation at Endpoint.||0.42|-0.10|0.222
70899211|NCT00118716|141286951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.096||0.294|TWO_SIDED|95.0|-0.29|0.09||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for emotional function at Week 2.||0.09|-0.29|0.294
70899212|NCT00118716|141286951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.111||0.828|TWO_SIDED|95.0|-0.24|0.19||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for emotional function at Week 4.||0.19|-0.24|0.828
70899213|NCT00118716|141286951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.103||0.903|TWO_SIDED|95.0|-0.19|0.22||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for emotional function at Endpoint.||0.22|-0.19|0.903
70899214|NCT00118716|141286951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.112||0.464|TWO_SIDED|95.0|-0.3|0.14|||ANCOVA|LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.||FSC 100/50mcg BID versus FP 100mcg BID for symptoms at Week 2.||0.14|-0.30|0.464
70899215|NCT00118716|141286951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.124||0.551|TWO_SIDED|95.0|-0.32|0.17||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for symptoms at Week 4.||0.17|-0.32|0.551
70899216|NCT00118716|141286951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.123||0.633|TWO_SIDED|95.0|-0.3|0.18||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for symptoms at Endpoint.||0.18|-0.30|0.633
70899217|NCT00118716|141286951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.094||0.7|TWO_SIDED|95.0|-0.22|0.15||LS Mean Diff, SE, CI, and p-values are from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for overall score at Week 2.||0.15|-0.22|0.700
70899218|NCT00118716|141286951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.109||0.86|TWO_SIDED|95.0|-0.23|0.2||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for overall score at Week 4.||0.20|-0.23|0.860
70899219|NCT00118716|141286951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.103||0.919|TWO_SIDED|95.0|-0.19|0.21||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for overall score at Endpoint.||0.21|-0.19|0.919
70899220|NCT02436811|141286958|SUPERIORITY_OR_OTHER||||||<|0.001||||||A stepwise forward selection model was used. All independent variables with P\<0.20 in the univariate analysis were selected and those which were significant (P\<0.05) were kept in the final model. The level of significance was 5%.|Regression, Poisson|||Univariate and multivariate Poisson regressions with robust variance were obtained to estimate the rate ratios (RR) and their respective 95% confidence intervals. Two Poisson regression models were generated, using the knowledge score 15 minutes after the intervention (post-test) and 4 weeks after the interventions (follow-up test) as dependent variables.||||<0.001
70899221|NCT03595332|141286959|EQUIVALENCE|The analysis tests whether for both groups combined, the baseline to 10-week follow-up BMI percentile scores are significantly different from zero.|Mean Difference (Final Values)|1.137|STANDARD_ERROR_OF_MEAN|0.9846||0.248|TWO_SIDED|95.0|-0.793|3.067||This test compares baseline to 10-week post-test for both groups combined, to test the null hypothesis that the BMI Percentile score would not be different from zero. A p-value of 0.05 was used as a priori threshold for statistical significance.|Regression, Linear|Linear regression with Generalized Estimating Equations to account for nested data structure of 222 children nested within 150 families and 4 schools.||||3.067|-0.793|0.248
70899222|NCT03595332|141286960|EQUIVALENCE|Analysis tested whether BMI Percentile score change among overweight participants (BMI equal or greater than 85th percentile at baseline) significantly changed from baseline to follow-up (was significantly different from zero). This was a subset analysis among the highest risk participants in the study.|Mean Difference (Final Values)|-3.173|STANDARD_ERROR_OF_MEAN|1.34||0.018|TWO_SIDED|95.0|-5.806|-0.541||The p-value threshold was 0.05 for all comparisons.|Regression, Linear|Linear regression with Generalized Estimating Equations to account for nested data structure of children within schools and families.|A negative parameter suggests a decreased BMI Percentile.|||-0.541|-5.806|0.018
70899223|NCT03595332|141286961|EQUIVALENCE|Analysis tested the difference in BMI percentile between baseline and 1-year follow-up among participants in the immediate intervention group to test the null hypothesis that no change occurred.|Mean Difference (Final Values)|0.363|STANDARD_ERROR_OF_MEAN|1.676||0.829|TWO_SIDED|95.0|-2.922|3.648||A prior threshold for statistical significance was 0.05. No adjustment for multiple comparisons was made.|Regression, Linear|Analysis included Generalized Estimating Equations with linear response variable, accounting for nested data structure.||||3.648|-2.922|0.829
70899224|NCT03595332|141286962|EQUIVALENCE|Analysis test whether for both groups combined, Baseline to 10-week change in reported intention of physical activity was significantly different from zero.|Mean Difference (Final Values)|0.284|STANDARD_ERROR_OF_MEAN|0.128||0.026|TWO_SIDED|95.0|0.034|0.534||A priori threshold for statistical significance is 0.05. No adjustments for multiple comparisons were made.|Regression, Linear|Linear regression models with Generalized Estimating Equations to account for nested data were made.|A positive parameter would suggest an increase in intentions to be physically active.|||0.534|0.034|0.026
70899225|NCT00117676|141286982|NON_INFERIORITY_OR_EQUIVALENCE|With a sample size of 200 subjects in the tenofovir DF group and 100 subjects in the adefovir dipivoxil group, a two group large-sample normal approximation test of proportions with a one-sided 0.025 significance level would have 95% power to reject the null hypothesis that the tenofovir DF treatment was inferior to the adefovir dipivoxil treatment (difference in proportions was less than -0.100) in favor of the alternative hypothesis that the tenofovir DF treatment was not inferior.|Difference in proportions|23.5|STANDARD_ERROR_OF_MEAN|5.2|<|0.001|TWO_SIDED|95.0|13.2|33.8||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted (baseline ALT ≥ 2 x ULN or \> 2 x ULN) difference is 0.|Z-test|||A two-sided 95% confidence interval (CI), stratified by baseline ALT (≤ 2 x ULN or \> 2 x ULN) was used to evaluate the difference (tenofovir DF - adefovir dipivoxil) in the proportion of complete responders between treatment groups.||33.8|13.2|<0.001
70899226|NCT00117676|141286983|SUPERIORITY_OR_OTHER||Difference in proportions|30.3|STANDARD_ERROR_OF_MEAN|4.6|<|0.001|TWO_SIDED|95.0|21.3|39.2||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference is zero. Difference, standard error of the difference, and the CI are stratum adjusted based on baseline ALT category (≤ 2 x ULN or \> 2 x ULN).|Z-test|||||39.2|21.3|<0.001
70899227|NCT00117676|141286984|SUPERIORITY_OR_OTHER||Difference in proportions|1.4|STANDARD_ERROR_OF_MEAN|3.4||0.672|TWO_SIDED|95.0|-5.2|8.0||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference is zero. Two-sided 95% confidence intervals, stratified by baseline ALT (baseline ALT ≤ 2 x ULN, \> 2 x ULN), were used to evaluate treatment arm differences.|Z-test|||||8.0|-5.2|0.672
70899228|NCT00117676|141286989|SUPERIORITY_OR_OTHER||Difference in proportions|5.2|STANDARD_ERROR_OF_MEAN|5.0||0.293|TWO_SIDED|95.0|-4.5|14.9||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference is zero. Confidence interval stratum adjusted based on baseline ALT (≤ 2 x ULN, \> 2 x ULN).|Z-test|||||14.9|-4.5|0.293
70899229|NCT00117676|141286995|SUPERIORITY_OR_OTHER||Difference in proportions|-0.8|STANDARD_ERROR_OF_MEAN|4.8||0.859|TWO_SIDED|95.0|-10.2|8.5||Statistical tests were not adjusted for baseline ALT stratum. Analysis set included only randomized and treated participants with baseline ALT \> ULN (biochemically evaluable analysis set).|Z-test|P-value corresponds to a Z-test of the null hypothesis that the ALT stratum-adjusted difference is zero.||||8.5|-10.2|0.859
70899230|NCT00117676|141286996|SUPERIORITY_OR_OTHER||Difference in proportions|4.9|STANDARD_ERROR_OF_MEAN|5.3||0.359|TWO_SIDED|95.0|-5.5|15.3||P-value corresponds to a Z-test of the null hypothesis that the ALT stratum-adjusted difference is zero.|Z-test|Difference, standard error of the difference, and confidence interval are stratum adjusted (baseline ALT ≤ 2 x ULN or \> 2 x ULN).||||15.3|-5.5|0.359
70899231|NCT00952822|141287014|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence limits of -0.223 to 0.223 in accordance with FDA Guidance for Industry: Statistical Approaches to Establishing Bioequivalence; 2001.|Difference of Least-Squares Means|-0.052||||||90.0|-0.117|0.012||||||||0.012|-0.117|
70899232|NCT00952822|141287015|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence limits of -0.223 to 0.223 in accordance with FDA Guidance for Industry: Statistical Approaches to Establishing Bioequivalence; 2001.|Difference of Least-Squares Means|-0.016||||||90.0|-0.076|0.043||||||||0.043|-0.076|
70899233|NCT01250990|141287029|SUPERIORITY_OR_OTHER|||||||0.8||||||p value is for comparison between changes in reverse cholesterol transport in niacin versus placebo groups after 12 weeks of treatment.|t-test, 2 sided|||This is a pilot study to assess the effects of niacin on reverse cholesterol transport. The null hypothesis is that niacin has no effect on reverse cholesterol transport.||||0.8
70899234|NCT01106430|141287097|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.001||95.0|||||Peto-Peto-Prentice Wilcoxon Test|||||||=0.001
70899235|NCT01106430|141287098|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.1||||0.001|TWO_SIDED|95.0|7.5|28.7|||Cochran-Mantel-Haenszel|||||28.7|7.5|0.001
70899236|NCT01106430|141287099|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-6.5|||<|0.001|TWO_SIDED|95.0|-9.3|-3.6|||ANCOVA|||||-3.6|-9.3|<0.001
70899237|NCT01106430|141287100|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.09||||0.046|TWO_SIDED|95.0|-0.17|0.0|||ANCOVA|||||-0.00|-0.17|0.046
70899238|NCT03286751|141287130|SUPERIORITY||Ratio of Geometric LSMeans|1.01||||0.5495|TWO_SIDED|95.0|0.974|1.05|||Mixed Models Analysis|||||1.05|0.974|0.5495
70899239|NCT03286751|141287130|SUPERIORITY||Ratio of Geometric LSMeans|1.02||||0.2236|TWO_SIDED|95.0|0.986|1.06|||Mixed Models Analysis|||||1.06|0.986|0.2236
70899240|NCT03286751|141287130|SUPERIORITY||Ratio of Geometric LSMeans|1.03||||0.0727|TWO_SIDED|95.0|0.997|1.07|||Mixed Models Analysis|||||1.07|0.997|0.0727
70899241|NCT03286751|141287131|SUPERIORITY||Ratio of Geometric LSMeans|0.97||||0.5749|TWO_SIDED|95.0|0.87|1.08|||Mixed Models Analysis|||||1.08|0.87|0.5749
70899242|NCT03286751|141287131|SUPERIORITY||Ratio of Geometric LSMeans|0.92||||0.1578|TWO_SIDED|95.0|0.83|1.03|||Mixed Models Analysis|||||1.03|0.83|0.1578
70899243|NCT03286751|141287131|SUPERIORITY||Ratio of Geometric LSMeans|0.92||||0.1351|TWO_SIDED|95.0|0.83|1.03|||Mixed Models Analysis|||||1.03|0.83|0.1351
70899244|NCT02313909|141287198|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.51884|TWO_SIDED|95.0|0.87|1.33|||Log Rank|||Statistical analysis: Stroke + Systemic embolism: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||1.33|0.87|0.51884
70899245|NCT02313909|141287199|SUPERIORITY||Hazard Ratio (HR)|2.72||||2e-05|TWO_SIDED|95.0|1.68|4.39|||Log Rank|||Statistical analysis: ISTH major bleeding events: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||4.39|1.68|0.00002
70899246|NCT02313909|141287200|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.56922|TWO_SIDED|95.0|0.87|1.29|||Log Rank|||Statistical analysis: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Confidence intervals were calculated, if at least 1 event in each treatment arm existed. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||1.29|0.87|0.56922
70899247|NCT02313909|141287201|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.22078|TWO_SIDED|95.0|0.87|1.81|||Log Rank|||Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Confidence intervals were calculated, if at least 1 event in each treatment arm existed. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||1.81|0.87|0.22078
70899248|NCT02313909|141287202|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.4797|TWO_SIDED|95.0|0.87|1.34|||Log Rank|||Statistical analysis 1: Stroke: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||1.34|0.87|0.47970
70899249|NCT02313909|141287202|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.78738|TWO_SIDED|95.0|0.83|1.29|||Log Rank|||Statistical analysis 2: Ischemic stroke: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||1.29|0.83|0.78738
70899250|NCT02313909|141287202|SUPERIORITY||Hazard Ratio (HR)|1.42||||0.14822|TWO_SIDED|95.0|0.88|2.28|||Log Rank|||Statistical analysis 3: Disabling stroke: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||2.28|0.88|0.14822
70899251|NCT02313909|141287202|SUPERIORITY||Hazard Ratio (HR)|1.48||||0.14051|TWO_SIDED|95.0|0.87|2.52|||Log Rank|||Statistical analysis 4:CV death: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||2.52|0.87|0.14051
70899252|NCT02313909|141287202|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.34284|TWO_SIDED|95.0|0.39|1.38|||Log Rank|||Statistical analysis 5: Myocardial infarction: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||1.38|0.39|0.34284
70899253|NCT02313909|141287203|SUPERIORITY||Hazard Ratio (HR)|2.34||||0.00443|TWO_SIDED|95.0|1.28|4.29|||Log Rank|||Statistical analysis: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||4.29|1.28|0.00443
70899254|NCT02313909|141287204|SUPERIORITY||Hazard Ratio (HR)|1.51||||0.00451|TWO_SIDED|95.0|1.13|2.0|||Log Rank|||Statistical analysis: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||2.00|1.13|0.00451
70899255|NCT02313909|141287205|SUPERIORITY||Hazard Ratio (HR)|2.01||||0.04409|TWO_SIDED|95.0|1.0|4.02|||Log Rank|||Statistical analysis 1: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||4.02|1.00|0.04409
70899256|NCT03086330|141287225|OTHER||Treatment difference|-1.42|||<|0.0001|TWO_SIDED|95.0|-1.61|-1.24|||ANCOVA|||The responses were analysed using an analysis of covariance (ANCOVA) with treatment, stratification factor and region as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomised treatment, using a regression model including stratification factor and region as categorical effects and data from baseline and all previous visits as covariates.||-1.24|-1.61|<0.0001
70899257|NCT03086330|141287226|OTHER||Treatment difference|-3.81|||<|0.0001|TWO_SIDED|95.0|-4.7|-2.93|||ANCOVA|||The responses were analysed using an ANCOVA with treatment, stratification factor and region as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomised treatment, using a regression model including stratification factor and region as categorical effects and data from baseline and all previous visits as covariates.||-2.93|-4.70|<0.0001
70899258|NCT00834106|141287290|SUPERIORITY_OR_OTHER||Vaccine efficacy|76.0|||||TWO_SIDED|95.0|43.7|91.1|||||Vaccine efficacy = 100 \* \[1 - (incidence rate with V501 / incidence rate with placebo)\]. The pre-specified success criterion was that the lower bound of the 95% confidence interval for vaccine efficacy excludes 0%.|||91.1|43.7|
70899259|NCT00834106|141287291|SUPERIORITY_OR_OTHER||Vaccine efficacy|82.3|||||TWO_SIDED|95.0|38.3|96.7|||||Vaccine efficacy = 100 \* \[1 - (incidence rate with V501 / incidence rate with placebo)\]. The pre-specified success criterion was that the lower bound of the 95% confidence interval for vaccine efficacy excludes 0%.|||96.7|38.3|
70899260|NCT00834106|141287292|SUPERIORITY_OR_OTHER||Vaccine efficacy|100.0||||0.0072|TWO_SIDED|95.0|32.3|100.0|||Exact test, 1-sided||Vaccine efficacy = 100 \* \[1 - (incidence rate with V501 / incidence rate with placebo)\]. The pre-specified success criterion was that the lower bound of the 95% confidence interval for vaccine efficacy excludes 0%.|||100|32.3|0.0072
70899261|NCT00834106|141287298|SUPERIORITY_OR_OTHER||Vaccine efficacy|91.8|||||TWO_SIDED|95.0|79.8|97.4|||||Vaccine efficacy = 100 \* \[1 - (incidence rate with V501 / incidence rate with placebo)\].|||97.4|79.8|
70899262|NCT00834106|141287299|SUPERIORITY_OR_OTHER||Vaccine efficacy|93.2|||||TWO_SIDED|95.0|72.9|99.2|||||Vaccine efficacy = 100 \* \[1 - (incidence rate with V501 / incidence rate with placebo)\].|||99.2|72.9|
70899263|NCT03477279|141287300|SUPERIORITY||Risk Difference (RD)|0.9|||||TWO_SIDED|95.0|-5.6|7.3|||||Couple (HIV+ Women) - Individual (HIV+ Women)|||7.3|-5.6|
70899264|NCT03477279|141287301|SUPERIORITY||Risk Difference (RD)|6.6|||||TWO_SIDED|95.0|-0.8|14.0|||||Couple (HIV+ Women) - Individual (HIV+ Women)|||14.0|-0.8|
70899265|NCT03477279|141287302|SUPERIORITY||Risk Difference (RD)|10.0|||||TWO_SIDED|95.0|-1.7|21.7|||||Male Partners of Women in Couple - Male Partners of Women in Individual|||21.7|-1.7|
70899266|NCT03477279|141287303|SUPERIORITY||Risk Difference (RD)|16.6|||||TWO_SIDED|95.0|0.9|32.3|||||Male Partners of Women in Couple - Male Partners of Women in Individual|||32.3|0.9|
70899267|NCT03477279|141287304|SUPERIORITY||Risk Difference (RD)|15.1|||||TWO_SIDED|95.0|-1.6|31.8||||||||31.8|-1.6|
70899268|NCT03477279|141287305|SUPERIORITY||Risk Difference (RD)|-2.4|||||TWO_SIDED|95.0|-13.2|8.5|||||Male Partners of Women in Couple - Male Partners of Women in Individual|||8.5|-13.2|
70899269|NCT03477279|141287306|SUPERIORITY||Risk Difference (RD)|-4.5|||||TWO_SIDED|95.0|-10.0|10.7|||||Couple (HIV+ Women) - Individual (HIV+ Women)|||10.7|-10.0|
70899270|NCT03477279|141287307|OTHER||Odds Ratio (OR)|4.9|||||TWO_SIDED|95.0|1.7|13.9||||||||13.9|1.7|
70899271|NCT03088267|141287368|SUPERIORITY||Mean Difference (Final Values)|-8.6||||0.0118|TWO_SIDED|95.0|-14.94|-2.17|||ANCOVA|||||-2.17|-14.94|0.0118
70899272|NCT03088267|141287369|SUPERIORITY||Mean Difference (Final Values)|18.8||||0.1128|TWO_SIDED|95.0|-4.94|42.5|||ANCOVA|||Comparison at 30 minutes post-dose||42.50|-4.94|0.1128
70899273|NCT03088267|141287369|SUPERIORITY||Mean Difference (Final Values)|60.3||||0.0003|TWO_SIDED|95.0|32.91|87.75|||ANCOVA|||Comparison at 3 hours postdose||87.75|32.91|0.0003
70899274|NCT00724152|141287407|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||Null hypothesis: The Cognitive Behavioral Therapy group would not demonstrate decreased distress at post-treatment as compared to the Tinnitus Education group on the primary outcome measure (THI) between pre-treatment and post-treatment.||||<0.05
70899275|NCT01542957|141287460|SUPERIORITY_OR_OTHER||Slope|-0.96|STANDARD_ERROR_OF_MEAN|0.69||0.6|TWO_SIDED|95.0|-3.35|1.43|||Mixed Models Analysis|||||1.43|-3.35|0.60
70899276|NCT01542957|141287461|SUPERIORITY_OR_OTHER||Slope|1.27|STANDARD_ERROR_OF_MEAN|0.53||0.21|TWO_SIDED|95.0|-0.71|3.25|||Mixed Models Analysis|||||3.25|-0.71|0.21
70899277|NCT01542957|141287462|SUPERIORITY_OR_OTHER||Slope|-0.01||||0.84|TWO_SIDED|95.0|-0.14|0.12|||Mixed Models Analysis|||||0.12|-0.14|0.84
70899278|NCT00394355|141287482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.261|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way analysis of variance (ANOVA) model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."||||0.261
70899279|NCT00394355|141287482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.644|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way ANOVA model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."||||0.644
70899280|NCT00394355|141287483|SUPERIORITY_OR_OTHER_LEGACY|||||||0.359|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way ANOVA model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."||||0.359
70899281|NCT00394355|141287483|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way ANOVA model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."||||0.390
70899282|NCT00394355|141287484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.169|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way ANOVA model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."||||0.169
70899283|NCT00394355|141287484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.526|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way ANOVA model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."||||0.526
70899284|NCT00394355|141287485|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||Least square means and Pstd (pooled standard deviations) are obtained from the ANOVA model with treatment effects.||||<0.001
70899285|NCT00394355|141287485|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|||||||ANOVA|||Least square means and Pstd (pooled standard deviations) are obtained from the ANOVA model with treatment effects.||||0.023
70899286|NCT01648348|141287547|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.57|TWO_SIDED|95.0|0.73|1.77|||Log Rank|||||1.77|0.73|0.57
70899287|NCT01648348|141287548|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
70899288|NCT01648348|141287549|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.82|TWO_SIDED|95.0|0.66|1.69|||Log Rank|||||1.69|0.66|0.82
70899289|NCT01648348|141287551|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||||||0.19
70899290|NCT01648348|141287552|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||Future uncertainty symptom scale/item t-test, 2-sided, unpooled.||||0.55
70899291|NCT01648348|141287552|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||Visual disorder symptom scale/item t-test, 2-sided, unpooled.||||0.16
70899292|NCT01648348|141287552|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||Motor dysfunction symptom scale/item t-test, 2-sided, unpooled.||||0.99
70899293|NCT01648348|141287552|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||Communication deficit symptom scale/item t-test, 2-sided, unpooled.||||0.75
70899294|NCT01648348|141287552|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||Headaches symptom scale/item t-test, 2-sided, unpooled.||||0.17
70899295|NCT01648348|141287552|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||Seizures symptom scale/item t-test, 2-sided, unpooled.||||0.90
70899296|NCT01648348|141287552|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||Drowsiness symptom scale/item t-test, 2-sided, unpooled.||||0.82
70899297|NCT01648348|141287552|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||Itchy skin symptom scale/item t-test, 2-sided, unpooled.||||0.15
70899298|NCT01648348|141287552|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||Hair loss symptom scale/item t-test, 2-sided, unpooled.||||0.77
70899299|NCT01648348|141287552|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||Weakness of legs symptom scale/item t-test, 2-sided, unpooled.||||0.10
70899300|NCT01648348|141287552|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|||Bladder control symptom scale/item t-test, 2-sided, unpooled.||||0.65
70899301|NCT01648348|141287553|SUPERIORITY|||||||0.83|||||||proportion test|||||||0.83
70899302|NCT02532556|141287557|SUPERIORITY||||||<|0.05|||||||Wilcoxan signed-rank test|||||||<0.05
70899303|NCT02532556|141287558|SUPERIORITY||||||<|0.05|||||||Wilcoxan signed-rank test|||||||<0.05
70899304|NCT00696410|141287560|SUPERIORITY_OR_OTHER|||||||0.068|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||p value represents test of paired (within patient) difference||||0.068
70899305|NCT00696410|141287560|SUPERIORITY_OR_OTHER|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||p value tests difference between the marker in CHF patients at time 0 and Health Controls (between group)||||0.022
70899306|NCT00696410|141287561|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED|95.0|||||Sign test|||p value represents test of paired (within patient) difference||||0.71
70899307|NCT00696410|141287561|SUPERIORITY_OR_OTHER|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||p value tests difference between the marker in CHF patients at time 0 and Health Controls (between group)||||0.33
70899308|NCT00696410|141287562|SUPERIORITY_OR_OTHER|||||||0.69|||||||Sign test|||p value represents test of paired (within patient) difference||||0.69
70899309|NCT00696410|141287562|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||p value tests difference between the marker in CHF patients at time 0 and Health Controls (between group)||||0.004
70899310|NCT00696410|141287563|SUPERIORITY_OR_OTHER|||||||0.48|||||||Sign test|||p value represents test of paired (within patient) difference||||0.48
70899311|NCT00696410|141287563|SUPERIORITY_OR_OTHER|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||p value tests difference between the marker in CHF patients at time 0 and Health Controls (between group)||||0.39
70899312|NCT00696410|141287564|SUPERIORITY_OR_OTHER|||||||0.92|||||||Sign test|||p value represents test of paired (within patient) difference||||0.92
70899313|NCT00696410|141287564|SUPERIORITY_OR_OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||p value tests difference between the marker in CHF patients at time 0 and Health Controls (between group)||||0.22
70899314|NCT01951638|141287568|OTHER||Log-Scale mean difference|0.137|||=|0.8991|TWO_SIDED|90.0|-0.04|0.31|||t-test, 1 sided|||For the primary analysis, the three highest active treatment groups BAY1021189 (2.5mg, 2.5 to 5mg, 2.5 to 10mg) were pooled and compared to the assigned placebo treatment group with a one-sided two-sample t-test. The Hochberg procedure was used to test the two primary end points at study-wise significance level of 5%. Results are reported including 90% confidence intervals (CI) for the difference of means. The difference between the comparison groups is difference of means on the log scale.||0.31|-0.04|= 0.8991
70899315|NCT01951638|141287568|OTHER||Log-Scale mean difference|0.076|||=|0.7194|TWO_SIDED|95.0|-0.18|0.33|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||0.33|-0.18|= 0.7194
70899316|NCT01951638|141287568|OTHER||Log-Scale mean difference|0.156|||=|0.8653|TWO_SIDED|95.0|-0.12|0.43|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||0.43|-0.12|= 0.8653
70899317|NCT01951638|141287568|OTHER||Log-Scale mean difference|0.171|||=|0.9041|TWO_SIDED|95.0|-0.09|0.43|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||0.43|-0.09|= 0.9041
70899318|NCT01951638|141287568|OTHER||Log-Scale mean difference|0.052|||=|0.6572|TWO_SIDED|95.0|-0.2|0.3|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||0.3|-0.2|= 0.6572
70899319|NCT01951638|141287569|OTHER||Mean Difference (Net)|1.629|||=|0.8156|TWO_SIDED|90.0|-1.36|4.62|||t-test, 1 sided|||For the primary analysis, the three highest active treatment groups (BAY1021189 2.5mg, BAY1021189 2.5 to 5mg, BAY1021189 2.5 to 10mg) were pooled and compared to the assigned placebo treatment group with a one-sided two-sample t-test. The Hochberg procedure was used to test the two primary end points at study-wise significance level of 5%. Results are reported including 90% confidence intervals (CI) for the difference of means.||4.62|-1.36|= 0.8156
70899320|NCT01951638|141287569|OTHER||Mean Difference (Net)|1.707|||=|0.7945|TWO_SIDED|95.0|-2.39|5.8|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||5.8|-2.39|= 0.7945
70899321|NCT01951638|141287569|OTHER||Mean Difference (Net)|2.109|||=|0.7917|TWO_SIDED|95.0|-3.01|7.23|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||7.23|-3.01|= 0.7917
70899322|NCT01951638|141287569|OTHER||Mean Difference (Net)|1.219|||=|0.7241|TWO_SIDED|95.0|-2.82|5.26|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||5.26|-2.82|= 0.7241
70899323|NCT01951638|141287569|OTHER||Mean Difference (Net)|1.198|||=|0.7546|TWO_SIDED|95.0|-2.23|4.63|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||4.63|-2.23|= 0.7546
70899324|NCT03810534|141287607|SUPERIORITY||Mean Difference (Final Values)|-1.64|STANDARD_ERROR_OF_MEAN|3.24||0.62|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.62
70899325|NCT03810534|141287608|SUPERIORITY||Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|1.44||0.31|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.31
70899326|NCT03810534|141287609|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.33||0.93|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.93
70899327|NCT03810534|141287610|SUPERIORITY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.34||0.6|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.60
70899328|NCT03810534|141287611|SUPERIORITY||Mean Difference (Final Values)|2.24|STANDARD_ERROR_OF_MEAN|3.49||0.53|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.53
70899329|NCT03810534|141287612|SUPERIORITY||Mean Difference (Final Values)|0.78|STANDARD_ERROR_OF_MEAN|3.57||0.83|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.83
70899330|NCT03810534|141287613|SUPERIORITY||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|2.05||0.75|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.75
70899331|NCT03810534|141287614|SUPERIORITY||Mean Difference (Final Values)|1.44|STANDARD_ERROR_OF_MEAN|2.07||0.5|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.50
70899332|NCT03810534|141287615|SUPERIORITY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.5||0.48|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.48
70899333|NCT03810534|141287616|SUPERIORITY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.52||0.22|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.22
70899334|NCT03810534|141287617|SUPERIORITY||Mean ratio|0.96|STANDARD_ERROR_OF_MEAN|0.25||0.88|TWO_SIDED||||||Mixed Models Analysis|||||||.88
70899335|NCT03810534|141287618|SUPERIORITY||Mean ratio|0.72|STANDARD_ERROR_OF_MEAN|0.18||0.23|TWO_SIDED||||||Mixed Models Analysis|||||||.23
70899336|NCT02713711|141287624|SUPERIORITY|ANOVA. Sample was calculated with power of 80% and alpha of 0.05.||||||0.3262|||||||ANOVA|repeated measures ANOVA (Bonferroni post-test) for intragroup analysis||||||0.3262
70899337|NCT02713711|141287624|SUPERIORITY|ANOVA. Sample was calculated with power of 80% and alpha of 0.05.||||||0.01|||||||ANOVA|repeated measures ANOVA (Bonferroni post-test) for intragroup analysis||||||0.01
70899338|NCT02713711|141287624|SUPERIORITY|ANOVA. Sample was calculated with power of 80% and alpha of 0.05.||||||0.0646|||||||ANOVA|repeated measures ANOVA (Bonferroni post-test) for intragroup analysis||||||0.0646
70899339|NCT02713711|141287624|SUPERIORITY|ANOVA. Sample was calculated with power of 80% and alpha of 0.05.|||||<|0.001|||||||ANOVA|repeated measures ANOVA (Bonferroni post-test) for intragroup analysis||||||<0.001
70899340|NCT02713711|141287624|SUPERIORITY|Two-way ANOVA (Bonferroni post-test) for intergroup analysis.|||||<|0.001|||||||ANOVA|||||||<0.001
70899341|NCT02713711|141287625|SUPERIORITY|paired-t test (intragroup analysis)||||||0.208|||||||t-test, 2 sided|||||||0.2080
70899342|NCT02713711|141287625|SUPERIORITY|paired-t test (intragroup analysis)||||||0.0136|||||||t-test, 2 sided|||||||0.0136
70899343|NCT02713711|141287625|SUPERIORITY|paired-t test (intragroup analysis)||||||0.2987|||||||t-test, 2 sided|||||||0.2987
70899344|NCT02713711|141287625|SUPERIORITY|paired-t test (intragroup analysis)||||||0.8347|||||||t-test, 2 sided|||||||0.8347
70899345|NCT02713711|141287625|SUPERIORITY|two-way ANOVA with Bonferroni post hoc test (intergroup analysis)||||||0.0001|||||||ANOVA|||||||0.0001
70899346|NCT00998400|141287629|SUPERIORITY|||||||0.03|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||0.030
70899347|NCT00998400|141287630|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
70899348|NCT00998400|141287631|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
70899349|NCT00998400|141287632|SUPERIORITY||||||>|0.05|||||||Kaplan-Meier Survival analysis|||||||>0.05
70899350|NCT00998400|141287633|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
70899351|NCT00998400|141287634|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
70899352|NCT00998400|141287635|SUPERIORITY|||||||0.013|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||0.013
70899353|NCT00998400|141287636|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
70899354|NCT00998400|141287637|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
70899355|NCT00998400|141287638|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
70899356|NCT00998400|141287639|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
70899357|NCT00998400|141287640|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
70899358|NCT01493687|141287675|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
70899359|NCT01493687|141287676|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-8.13|||<|0.001|TWO_SIDED|95.0|-10.12|-6.13|||ANCOVA|||||-6.13|-10.12|<0.001
70899360|NCT01493687|141287677|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
70899361|NCT00089141|141287688|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.66||||0.22||95.0|0.7|3.7||P values are 2 sided and are based on likelihood ratio statistics.|Regression, Cox|Analysis for all endpoints was stratified by number of affected organs and type of conditioning regimen.|For all analyses, MMF arm in numerator, and placebo arm in denominator. Hazard ratio estimate includes 3 efficacy success events that occurred after two years in the placebo arm.|||3.7|0.7|.22
70899362|NCT00089141|141287689|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.65||||0.03||95.0|1.1|2.6|||Regression, Cox|Statistical analysis did not count treatment continuing beyond 2 years as efficacy failure (n = 2 in each arm).||||2.6|1.1|.03
70899363|NCT00089141|141287690|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.55||95.0|0.7|2.1|||Regression, Cox|||||2.1|0.7|.55
70899364|NCT00089141|141287691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.61||||0.48||95.0|0.4|6.0|||Regression, Cox|||||6.0|0.4|.48
70899365|NCT00089141|141287692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.74||||0.17||95.0|0.8|3.9|||Regression, Cox|adjusted for risk category||||3.9|0.8|.17
70899366|NCT00089141|141287693|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.62||||0.41||95.0|0.5|5.0|||Regression, Cox|||||5.0|0.5|.41
70899367|NCT00089141|141287694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.69||||0.14||95.0|0.9|3.2|||Regression, Cox|||||3.2|0.9|.14
70899368|NCT00089141|141287695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.99||||0.1||95.0|0.9|4.3|||Regression, Cox|||||4.3|0.9|.10
70899369|NCT00089141|141287696|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.28||||0.34||95.0|0.08|2.1|||Regression, Cox|||||2.1|.08|.34
70899370|NCT00089141|141287697|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51||||0.28||95.0|0.7|3.2|||Regression, Cox|||||3.2|0.7|.28
70899371|NCT00508261|141287698|NON_INFERIORITY|Criterion for non-inferiority: The lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference in the percentages of subjects with serum bactericidal antibodies using baby rabbit complement (rSBA) titer ≥1:8 is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|1.64|||||TWO_SIDED|95.0|-0.33|4.71||||||Demonstration of the non-inferiority of Nimenrix vaccine co-administered with combined Infanrix-hexa vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroup A, at month 1.||4.71|-0.33|
70899372|NCT00508261|141287698|NON_INFERIORITY|Criterion for non-inferiority: The lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference in the percentages of subjects with serum bactericidal antibodies using baby rabbit complement (rSBA) titer ≥1:8 is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|2.73|||||TWO_SIDED|95.0|0.73|6.24||||||Demonstration of the non-inferiority of the Nimenrix vaccine co-administered with combined Infanrix-hexa vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroup C, at month 1.||6.24|0.73|
70899373|NCT00508261|141287698|NON_INFERIORITY|Criterion for non-inferiority: The lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference in the percentages of subjects with serum bactericidal antibodies using baby rabbit complement (rSBA) titer ≥1:8 is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|1.61|||||TWO_SIDED|95.0|-0.36|4.64||||||Demonstration of the non-inferiority of the Nimenrix vaccine co-administered with combined Infanrix-hexa vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroup W-135, at month 1.||4.64|-0.36|
70899374|NCT00508261|141287698|NON_INFERIORITY|Criterion for non-inferiority: The lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference in the percentages of subjects with serum bactericidal antibodies using baby rabbit complement (rSBA) titer ≥1:8 is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|2.7|||||TWO_SIDED|95.0|0.71|6.18||||||Demonstration of the non-inferiority of the Nimenrix vaccine co-administered with combined Infanrix-hexa vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroup Y, at month 1.||6.18|0.71|
70899375|NCT00508261|141287699|NON_INFERIORITY|Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided 95% CI on the GMC ratio for anti-PT (ELISA) is greater than or equal to a pre-defined clinical limit of delta = 0.67.|Adjusted GMC ratios|0.97|||||TWO_SIDED|95.0|0.83|1.12||||||Demonstration of non-inferiority of combined Infanrix-hexa vaccine co-administered with Nimenrix vaccine to Infanrix-hexa vaccine given alone in terms of geometric mean concentrations (GMCs) of antibodies to pertussis toxoid (PT), at month 1.||1.12|0.83|
70899376|NCT00508261|141287699|NON_INFERIORITY|Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided 95% CI on the GMC ratio for anti-FHA (ELISA) is greater than or equal to a pre-defined clinical limit of delta = 0.67.|Adjusted GMC ratios|0.98|||||TWO_SIDED|95.0|0.85|1.13||||||Demonstration of non-inferiority of combined Infanrix-hexa vaccine co-administered with Nimenrix vaccine to Infanrix-hexa vaccine given alone in terms of geometric mean concentrations (GMCs) of antibodies to filamentous haemagglutinin (FHA), at month 1.||1.13|0.85|
70899377|NCT00508261|141287699|NON_INFERIORITY|Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided 95% CI on the GMC ratio for anti-PRN (ELISA) is greater than or equal to a pre-defined clinical limit of delta = 0.67.|Adjusted GMC ratios|0.92|||||TWO_SIDED|95.0|0.78|1.1||||||Demonstration of non-inferiority of combined Infanrix-hexa vaccine co-administered with Nimenrix vaccine to Infanrix-hexa vaccine given alone in terms of geometric mean concentrations (GMCs) of antibodies to pertactin (PRN), at month 1.||1.1|0.78|
70899378|NCT00508261|141287700|NON_INFERIORITY|Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided standardized asymptotic 95% CI for the group difference in the percentages of subjects with anti-HBs antibody concentrations ≥10 mIU/ml is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|1.22|||||TWO_SIDED|95.0|-1.47|4.6||||||||4.6|-1.47|
70899379|NCT00508261|141287701|NON_INFERIORITY|Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided standardized asymptotic 95% CI for the group difference in the percentage of subjects with anti-PRP concentrations (ELISA) ≥1.0 μg/mL is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|1.19|||||TWO_SIDED|95.0|-1.45|4.5||||||||4.5|-1.45|
70899380|NCT00180479|141287727|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculation for endpoint of in-segment LL at 240 days is based on these assumptions: one-tailed non-inferiority= (δ)=0.025, Power=99%, Randomization ratio 2:1, True mean in-seg. LL is assumed to be 0.24 mm in both arms.|||||<|0.0001|||||||t-test, 1 sided|||Primary endpoint analyzed for intent-to-treat \& per-treatment evaluable pop. Hypothesis test based on per-subject analysis of intent-to-treat pop. using analysis lesion. The null hypothesis evaluated using non-inferiority test with asymptotic test statistic.||||<0.0001
70899381|NCT00180479|141287728|NON_INFERIORITY_OR_EQUIVALENCE|Study had 89% statistical power based on major secondary endpoint to prove non-inferiority of XIENCE® V to TAXUS®, non-inferiority delta=5.5%, true TVF rate 9.4% in both arms with overall 5% alpha (one-sided), assuming 1% subject dropout rate.|||||<|0.0001|||||||t-test, 1 sided|||Null hypothesis was evaluated using a non-inferiority Z statistic. Non-inferiority was defined as a one-sided alpha of 0.05 and a difference in TVF rate of no more than 5.5%.||||<0.0001
70899382|NCT00106184|141287837|SUPERIORITY_OR_OTHER||||||=|0.74|TWO_SIDED||||||Log Rank|No confidence intervals as no parameters were estimated.||Proportional hazards model||||=0.74
70899383|NCT00106184|141287838|SUPERIORITY_OR_OTHER||||||>|0.9|TWO_SIDED|95.0|||||Chi-squared|Difference in baseline muscle enzymes therefore tested the difference in the proportions adjusting for the baseline values.||||||>0.90
70899384|NCT00106184|141287839|SUPERIORITY_OR_OTHER||||||>|0.9|||||||Log Rank|||||||>0.90
70899385|NCT01032733|141287840|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.06|STANDARD_DEVIATION|0.5|<|0.05|ONE_SIDED|95.0|||||ANCOVA|||This trial represented a pilot study, which was designed to demonstrate the feasibility, acceptability, and efficacy of the intervention; therefore, a power analysis was not conducted. The statistical analyses consisted of descriptive and intent-to-treat (ITT) modeling procedures.||||<0.05
70899386|NCT01032733|141287841|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0|STANDARD_DEVIATION|5.0|<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
70899387|NCT01032733|141287842|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|STANDARD_DEVIATION|2.0|<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
70899388|NCT01032733|141287843|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0|STANDARD_DEVIATION|15.0|<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
70899389|NCT01032733|141287844|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
70899390|NCT02231177|141287845|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.12|STANDARD_DEVIATION|32.15|||TWO_SIDED|90.0|0.99|1.27|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Olodaterol (Tiotropium+Olodaterol 5/10 μg: Olodaterol 10 µg). No formal testing.||1.27|0.99|
70899391|NCT02231177|141287846|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.11|STANDARD_DEVIATION|27.17|||TWO_SIDED|90.0|1.01|1.22|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Olodaterol (Tiotropium+Olodaterol 5/10 μg: Olodaterol 10 µg). No formal testing.||1.22|1.01|
70899392|NCT02231177|141287847|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.98|STANDARD_DEVIATION|20.43|||TWO_SIDED|90.0|0.91|1.06|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Tiotropium (Tiotropium+Olodaterol 5/10 μg: Tiotropium 5 µg). No formal testing.||1.06|0.91|
70899393|NCT02231177|141287848|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.05|STANDARD_DEVIATION|19.85|||TWO_SIDED|90.0|0.98|1.13|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Olodaterol (Tiotropium+Olodaterol 5/10 μg: Olodaterol 10 µg). No formal testing.||1.13|0.98|
70899394|NCT02231177|141287849|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.9|STANDARD_DEVIATION|19.81|||TWO_SIDED|90.0|0.83|0.98|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Tiotropium (Tiotropium+Olodaterol 5/10 μg: Tiotropium 5 µg). No formal testing.||0.98|0.83|
70899395|NCT02231177|141287850|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.96|STANDARD_DEVIATION|29.92|||TWO_SIDED|90.0|0.87|1.07|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Tiotropium (Tiotropium+Olodaterol 5/10 μg : Tiotropium 5 µg). No formal testing.||1.07|0.87|
70899396|NCT02231177|141287851|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.02|STANDARD_DEVIATION|21.33|||TWO_SIDED|90.0|0.93|1.12|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Olodaterol (Tiotropium+Olodaterol 5/10 μg : Olodaterol 10 µg). No formal testing.||1.12|0.93|
70899397|NCT02231177|141287852|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.91|STANDARD_DEVIATION|22.61|||TWO_SIDED|90.0|0.84|1.0|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Tiotropium (Tiotropium+Olodaterol 5/10 μg : Tiotropium 5 µg). No formal testing.||1.00|0.84|
70899398|NCT02231177|141287853|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.32|STANDARD_DEVIATION|96.12|||TWO_SIDED|90.0|0.98|1.77|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Olodaterol (Tiotropium+Olodaterol 5/10 μg; Olodaterol 10 µg). No formal testing.||1.77|0.98|
70899399|NCT02231177|141287854|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.99|STANDARD_DEVIATION|72.08|||TWO_SIDED|90.0|0.79|1.24|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Tiotropium (Tiotropium+Olodaterol 5/10 μg; Tiotropium 5 µg). No formal testing.||1.24|0.79|
70899400|NCT00409682|141287868|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.29||||0.075|TWO_SIDED|95.0|-3.14|23.71||There is no adjustment for multiple comparison on the primary outcome measure.|Cochran-Mantel-Haenszel||Difference is between adalimumab High-dose and adalimumab Low-dose group.|The point estimates for the number of subjects who achieved PCDAI clinical remission in each treatment group and the difference in number between the groups were provided. The P value and 95% confidence intervals (CIs) for the difference were provided. The P value is from the CMH test adjusted for infliximab use and response status at Week 4. The primary analysis was performed for the intent-to-treat (ITT) using the non-responder (NRI) imputation method.||23.71|-3.14|0.075
70899401|NCT00409682|141287869|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.18||||0.1|TWO_SIDED|95.0|-2.62|22.97||The hierarchical stepwise closed testing procedure was implemented to control the overall significance level at 0.05 in the ITT population.|Cochran-Mantel-Haenszel||A significance test for any individual major secondary efficacy endpoint in the hierarchy was to be inferential only if the hypothesis tests of all preceding major secondary efficacy endpoints were statistically significant at 0.050.|The point estimates for the number of subjects who achieved PCDAI clinical remission in each treatment group and the difference in number between the groups were provided. The P value and 95% CIs for the difference were provided. The analysis was performed for the intent-to-treat (ITT) population using the non-responder imputation (NRI) method.||22.97|-2.62|0.100
70899402|NCT00409682|141287870|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.72||||0.073|TWO_SIDED|95.0|-3.45|24.89||The hierarchical stepwise closed testing procedure was implemented to control the overall significance level at 0.05 in the ITT population|Cochran-Mantel-Haenszel||A significance test for any individual major secondary efficacy endpoint in the hierarchy was to be inferential only if the hypothesis tests of all preceding major secondary efficacy endpoints were statistically significant at 0.050.|The point estimates for the number of subjects who achieved PCDAI clinical response in each treatment group and the difference in number between the groups were provided. The P value and 95% confidence intervals (CIs) for the difference were provided. The analysis was performed for the intent-to-treat (ITT) population using the non-responder imputation (NRI) method.||24.89|-3.45|0.073
70899403|NCT00409682|141287871|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.51||||0.038|TWO_SIDED|95.0|-0.01|27.04||The hierarchical stepwise closed testing procedure was implemented to control the overall significance level at 0.05 in the ITT population|Cochran-Mantel-Haenszel||A significance test for any individual major secondary efficacy endpoint in the hierarchy was to be inferential only if the hypothesis tests of all preceding major secondary efficacy endpoints were statistically significant at 0.050.|The point estimates for the number of subjects who achieved PCDAI clinical response in each treatment group and the difference in number between the groups were provided. The P value and 95% confidence intervals (CIs) for the difference were provided. The analysis was performed for the intent-to-treat (ITT) population using the non-responder imputation (NRI) method.||27.04|-0.01|0.038
70899404|NCT00409682|141287872|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1|STANDARD_ERROR_OF_MEAN|2.903||0.161|TWO_SIDED|95.0|-9.86|1.66||The hierarchical stepwise closed testing procedure was implemented to control the overall significance level at 0.05 in the ITT population.|ANCOVA||Difference is between adalimumab High-dose and adalimumab Low-dose groups. Baseline means include subjects who had both Baseline and post-Baseline measurements.|"Analyzed as change from Baseline to Week 26, and compared between the two treatment groups. The estimated treatment mean difference, P values, and 95% CI for the treatment difference were provided. Analysis was conducted in the ITT population for OC.~The P value is from the ANCOVA model with treatment as a factor, adjusted for the baseline value, and the strata (response status at Week 4 and prior infliximab experience)."||1.66|-9.86|0.161
70899405|NCT00409682|141287873|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|2.941||0.735|TWO_SIDED|95.0|-6.88|4.88|||ANCOVA||Difference is between adalimumab High-dose and adalimumab Low-dose groups. Baseline means include subjects who had both Baseline and post-Baseline measurements.|Analyzed as change from Baseline to Week 52, and compared between the two treatment groups. The estimated treatment mean difference, P values, and 95% confidence interval (CI) for the treatment difference were provided. Analysis was conducted in the ITT population for OC.||4.88|-6.88|0.735
70899406|NCT00252538|141287889|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||All statistics employed Statistical Package for Social Science (SPSS) 17.0. Analysis of variances were used to compare viral responses in genotypes of interest, employing Scheffe's post-hoc analyses. Repeated-measure mixed-effect analyses were used to compare changes in subjective symptoms over time, including age, gender, and self identified race as covariates. Kaplan-Meier survival analyses examining time until MDD development were compared using theMantel-Cox log rank test.||||>0.05
70899407|NCT02856113|141287892|SUPERIORITY||Least Square (LS) Mean Difference|0.102|STANDARD_DEVIATION|0.3677|=|0.782|TWO_SIDED|95.0|-0.627|0.831||P-values was assessed at 0.05 significance level using MMRM.|MMRM||MMRM:Treatment,scheduled visit,antidiabetic therapy,visit-by-treatment interaction-categorical effects;Baseline HbA1c,visit-by-baseline HbA1c interaction-continuous covariates;unstructured covariance matrix for correlation of repeated measurements.|||0.831|-0.627|=0.782
70899408|NCT02856113|141287893|SUPERIORITY||LS Mean Difference|-0.046|STANDARD_DEVIATION|0.2635|=|0.863|TWO_SIDED|95.0|-0.567|0.476||P-values was assessed at 0.05 significance level using MMRM.|MMRM||MMRM:Treatment,scheduled visit,antidiabetic therapy,visit-by-treatment interaction-categorical effects;Baseline HbA1c,visit-by-baseline HbA1c interaction-continuous covariates;unstructured covariance matrix for correlation of repeated measurements.|Change From Baseline at Week 12||0.476|-0.567|=0.863
70899409|NCT02856113|141287893|SUPERIORITY||LS Mean Difference|0.004|STANDARD_DEVIATION|0.3123|=|0.99|TWO_SIDED|95.0|-0.614|0.622||P-values was assessed at 0.05 significance level using MMRM.|MMRM||MMRM:Treatment,scheduled visit,antidiabetic therapy,visit-by-treatment interaction-categorical effects;Baseline HbA1c,visit-by-baseline HbA1c interaction-continuous covariates;unstructured covariance matrix for correlation of repeated measurements.|Change From Baseline at Week 18||0.622|-0.614|=0.990
70899410|NCT02856113|141287893|SUPERIORITY||LS Mean Difference|-0.412|STANDARD_DEVIATION|0.3664|=|0.264|TWO_SIDED|95.0|-1.139|0.316||P-values was assessed at 0.05 significance level using MMRM.|MMRM||MMRM:Treatment,scheduled visit,antidiabetic therapy,visit-by-treatment interaction-categorical effects;Baseline HbA1c,visit-by-baseline HbA1c interaction-continuous covariates;unstructured covariance matrix for correlation of repeated measurements.|Change From Baseline at Week 39||0.316|-1.139|=0.264
70899411|NCT02856113|141287893|SUPERIORITY||LS Mean Difference|-0.483|STANDARD_DEVIATION|0.4165|=|0.25|TWO_SIDED|95.0|-1.314|0.348||P-values was assessed at 0.05 significance level using MMRM.|MMRM||MMRM:Treatment,scheduled visit,antidiabetic therapy,visit-by-treatment interaction-categorical effects;Baseline HbA1c,visit-by-baseline HbA1c interaction-continuous covariates;unstructured covariance matrix for correlation of repeated measurements.|Change From Baseline at Week 52||0.348|-1.314|=0.250
70899412|NCT03494166|141287904|SUPERIORITY|Key parameter was the coefficient for the trial arm variable in the mixed model, reflecting average difference of group means over time (weeks 1-13).|Mean Difference (Final Values)|-1.31|STANDARD_ERROR_OF_MEAN|1.32||0.31|TWO_SIDED|95.0|-3.9|1.25||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was set at .05.|Mixed Models Analysis|Linear mixed effects models were used for 13 repeated measures of symptom severity index, adjusting for baseline value.|The mean of the group that started with SMSH alone minus the mean of the group that started with SMSH+TIPC (average over time).|"The null hypothesis was that the means in two arms were equal, the alternative hypothesis was that the means were not equal.~We planned to randomize 224 survivors in approximately 3:1 ratio in the first randomization; power was 0.92 to detect the adjusted d=0.54 in the comparison of the SMSH and SMSH+TIPC in the first randomization. The planned number of 224 was exceeded because more survivors than planned were determined to have high need for symptom management."||1.25|-3.90|.31
70899413|NCT03494166|141287905|SUPERIORITY|The key parameter was the coefficient for the variable reflecting trial arm from the second randomization in the mixed model. This parameter reflected average difference between means of two groups over time (weeks 5-13).|Mean Difference (Final Values)|-2.18|STANDARD_ERROR_OF_MEAN|3.35||0.52|TWO_SIDED|95.0|-8.91|4.55||The p-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Linear mixed effects models were used for 9 repeated measures of symptom severity index (weeks 5-13), adjusting for baseline value.|The mean of the group that continued with SMSH alone minus the mean of the group that had TIPC added to the SMSH after week 4.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. The required sample size was 60 per group for .80 power or greater in two-tailed tests at the 0.05 level of significance using the effect size of Cohen's d=0.54 (adjusted for baseline and repeated measures). The actual sample size was smaller (61 total) due to the higher than planned rate of response to the SMSH alone by week 4.||4.55|-8.91|.52
70899414|NCT03494166|141287906|SUPERIORITY|Key parameter was the coefficient for the trial arm from the first randomization variable in the linear regression model.|Median Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|1.12||0.71|TWO_SIDED|95.0|-2.63|1.81||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Regression, Linear||The mean of group that started with SMSH alone minus the mean of the group that started with SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||1.81|-2.63|.71
70899415|NCT03494166|141287907|SUPERIORITY|The key parameter was the coefficient for the trial arm from the second randomization variable in linear regression model.|Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|2.91||0.79|TWO_SIDED|95.0|-6.53|5.01||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Regression, Linear|The model included the adjustment for baseline value of the outcome.|The mean of the group that continued with SMSH alone minus the mean of the group that had TIPC added to the SMSH after week 4.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||5.01|-6.53|.79
70899416|NCT02110901|141287914|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.254|TWO_SIDED|95.0|0.61|1.14|||Log Rank|||||1.14|0.61|0.254
70899417|NCT02110901|141287915|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.048|TWO_SIDED|95.0|0.43|1.0|||Log Rank|||||1.00|0.43|0.048
70899418|NCT02110901|141287916|SUPERIORITY|||||||0.109|||||||Chi-squared|||||||0.109
70899419|NCT02110901|141287917|SUPERIORITY|||||||0.035|||||||Chi-squared|||||||0.035
70899420|NCT00855595|141287949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0903|||||||ANCOVA|||||||0.0903
70899421|NCT00166296|141287965|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.4||||0.441|TWO_SIDED|95.0|0.075|2.141|||Fisher Exact|||||2.141|0.075|0.441
70899422|NCT00166296|141287966|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Chi-squared|||||||>0.05
70899423|NCT00166296|141287967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.443||95.0|||||ANOVA|||||||0.443
70899424|NCT00166296|141287968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93||95.0|||||ANOVA|||||||0.930
70899425|NCT01422408|141287999|OTHER|Two-sided test that the change is different from zero. Not tested against alternative treatment; single arm study.|||||<|0.001||||||2.5% significance level to account for two co-primary endpoints.|Wilcoxon (Mann-Whitney)|||The primary endpoints (i.e., change in symptoms of vaginal dryness from the baseline to 4 weeks, and change in symptoms of dyspareunia from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints.||||<0.001
70899426|NCT01422408|141287999|OTHER|Exact McNemar's test was used to test if the proportion of severe symptoms at baseline are equal to the proportion of severe symptoms at the end of the study.|Odds Ratio (OR)|0.0||||0.001|TWO_SIDED|95.0|0.0|0.36||Since there are two-co-primary endpoints, the significance level is 2.5%|McNemar|||"GEE (general estimating equation) methods were planned as a secondary analysis of the primary endpoints. Missing data for some of the weeks prevented these models from converging and we could not obtain valid results with these methods. Since this is a secondary analysis, we decided to compare symptom severity at baseline vs. week 4 (end of study). Symptoms are considered severe for scores 3 or 4 and not severe for scores 0, 1, 2"||0.36|0|0.001
70899427|NCT01422408|141288000|OTHER|Two-sided test that the change is different from zero. Not tested against alternative treatment; single arm study.||||||0.002||||||2.5% significance level to account for two co-primary endpoints.|Wilcoxon (Mann-Whitney)|||The primary endpoints (i.e., change in symptoms of vaginal dryness from the baseline to 4 weeks, and change in symptoms of dyspareunia from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints.||||0.002
70899428|NCT01422408|141288000|OTHER|Exact McNemar's test was used to test if the proportion of severe symptoms at baseline are equal to the proportion of severe symptoms at the end of the study.|Odds Ratio (OR)|0.0||||0.062|TWO_SIDED|95.0|0.0|1.09||Since there are two-co-primary endpoints, the significance level is 2.5%|McNemar|||"GEE (general estimating equations) methods were planned as a secondary analysis of the primary endpoints. Missing data for some of the weeks prevented these models from converging and we could not obtain valid results with these methods. Since this is a secondary analysis, we decided to compare symptom severity at baseline vs. week 4 (end of study). Symptoms are considered severe for scores 3 or 4 and not severe for scores 0, 1, 2"||1.09|0|0.062
70899429|NCT01422408|141288001|OTHER|Two-sided test that the change is different from zero. Not tested against alternative treatment; single arm study.||||||0.001|||||||Wilcoxon (Mann-Whitney)|||The secondary endpoints (i.e., change in symptoms of vaginal itching from the baseline to 4 weeks, and change in vaginal index score from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.||||0.001
70899430|NCT01422408|141288002|OTHER|2.5% significance level to account for two co-primary endpoints.||||||0.002|||||||Wilcoxon (Mann-Whitney)|||The secondary endpoints (i.e., change in symptoms of vaginal itching from the baseline to 4 weeks, and change in vaginal index score from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.||||0.002
70899431|NCT01422408|141288004|OTHER|||||||0.1029||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.1029
70899432|NCT01422408|141288005|OTHER|||||||0.2678||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.2678
70899433|NCT01422408|141288006|OTHER|||||||0.2472||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.2472
70899434|NCT01422408|141288007|OTHER|||||||0.507||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.507
70899435|NCT01422408|141288008|OTHER|||||||0.3676||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.3676
70899436|NCT01422408|141288009|OTHER|||||||0.6023||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.6023
70899437|NCT01422408|141288010|OTHER|||||||0.6587||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.6587
70899438|NCT01422408|141288011|OTHER|||||||0.8772||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.8772
70899439|NCT01422408|141288012|OTHER|||||||0.7395||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.7395
70899440|NCT01422408|141288013|OTHER|||||||0.9618||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.9618
70899441|NCT01422408|141288014|OTHER|||||||0.5113||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.5113
70899442|NCT01422408|141288015|OTHER|||||||0.8833||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.8833
70899443|NCT01422408|141288016|OTHER|||||||0.7983||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.7983
70899444|NCT01422408|141288017|OTHER|||||||0.4937||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.4937
70899445|NCT01422408|141288018|OTHER|||||||0.9106||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.9106
70899446|NCT01422408|141288019|OTHER|||||||0.507||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.507
70899447|NCT01422408|141288020|OTHER|||||||0.3676||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.3676
70899448|NCT01422408|141288021|OTHER|||||||0.6023||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.6023
70899449|NCT01422408|141288022|OTHER|||||||0.08531||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.08531
70899450|NCT01422408|141288023|OTHER|||||||0.2011||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.2011
70899451|NCT01422408|141288024|OTHER|||||||0.1187||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.1187
70899452|NCT00386022|141288044|EQUIVALENCE|null hypothesis will be accepted if there is no difference in the LH response to GnRH as a function of dose in young or old postmenopausal women|||||<|0.001||||||LH % change with dose|Repeated measures ANCOVA|||||||<0.001
70899453|NCT00386022|141288044|EQUIVALENCE|null hypothesis will be accepted if there is no difference in the LH response to GnRH between younger and older postmenopausal women|||||<|0.03||||||LH % change with age|Repeated measures ANCOVA|||null hypothesis: there will be no difference in the LH and FSH responses to graded doses of GnRH between younger and older postmenopausal women||||<0.03
70899454|NCT00386022|141288044|EQUIVALENCE|null hypothesis will be accepted if there is no difference in the FSH response to GnRH as a function of dose in younger or older postmenopausal women|||||<|0.001||||||FSH % change with dose|Repeated measures ANCOVA|||||||<0.001
70899455|NCT00386022|141288044|EQUIVALENCE|null hypothesis will be accepted if there is no difference in the FSH response to GnRH between young and old postmenopausal women|||||<|0.005||||||FSH % change with age|Repeated measures ANCOVA|||||||<0.005
70899456|NCT00386022|141288045|EQUIVALENCE|null hypothesis will be accepted if there is no effect of estrogen on the LH response to GnRH in younger and older postmenopausal women|||||<|0.01||||||LH amplitude response with estrogen|Repeated measured ANCOVA|||||||<0.01
70899457|NCT00386022|141288045|EQUIVALENCE|The null hypothesis will be accepted if there is no effect of estrogen on the FSH response to GnRH in younger and older postmenopausal women|||||<|0.0001||||||FSH amplitude response with estrogen|Repeated measures ANCOVA|||||||<0.0001
70899458|NCT00386022|141288045|EQUIVALENCE|The null hypothesis will be accepted if there is no effect of age on the effect of estrogen on the FSH response to GnRH|||||<|0.02||||||FSH amplitude response to estrogen with age|Repeated measures ANCOVA|||||||<0.02
70899459|NCT00386022|141288045|EQUIVALENCE|The null hypothesis will be accepted if there is no effect of age on the effect of estrogen on the LH response to GnRH|||||=|0.4||||||LH amplitude response to estrogen with age|Repeated measures ANCOVA|||||||=0.4
70899460|NCT03371082|141288047|EQUIVALENCE|The limits of the lower and upper equivalence margin were -11.3 and 11.3, respectively.|Risk Difference (RD)|0.6|STANDARD_ERROR_OF_MEAN|3.63|||TWO_SIDED|90.0|-5.4|6.5|||||The asymptotic standard error was planned and is reported above.|This is a two-arm study.||6.5|-5.4|
70899461|NCT01064297|141288059|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|2.2||||||95.0|1.6|3.1|||||The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).|||3.1|1.6|
70899462|NCT01064297|141288059|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|4.2||||||95.0|1.4|11.0|||||The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).|||11.0|1.4|
70899463|NCT01064297|141288059|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|2.4||||||95.0|1.7|3.3|||||The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).|||3.3|1.7|
70899464|NCT01064297|141288060|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|10.7||||||95.0|6.4|17.0||||||||17.0|6.4|
70899465|NCT01064297|141288060|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|9.3||||||95.0|5.5|15.2|||||The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).|||15.2|5.5|
70899466|NCT01064297|141288061|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|2.8||||||95.0|1.5|5.0||||||||5.0|1.5|
70899467|NCT01064297|141288061|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|2.8||||||95.0|1.6|4.9|||||The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).|||4.9|1.6|
70899468|NCT01345630|141288079|NON_INFERIORITY_OR_EQUIVALENCE|For the analysis of the primary endpoint conducted at Week 48, the alternative hypothesis was to test for non-inferiority of MVC+DRV/r to FTC/TDF+DRV/r with a non-inferiority margin of -10%.|Mean Difference (Final Values)|-9.54|||||TWO_SIDED|95.0|-14.83|-4.24||||||The difference in the percentages between the maraviroc and the emtricitabine/tenofovir treatment arms and the 2-sided 95% confidence interval for the difference was provided using the stratum-adjusted Mantel-Haenszel (MH) method over the two assays and the screening plasma HIV-1 RNA levels (\>=100,000 copies/mL or \<100,000 copies/mL). The sample size was chosen to yield a power of ≥90%. The 95% CIs and mean difference (final values) are presented as percentages above.||-4.24|-14.83|
70899469|NCT01345630|141288087|SUPERIORITY_OR_OTHER||Treatment difference|-0.075|STANDARD_ERROR_OF_MEAN|0.0303|||TWO_SIDED|95.0|-0.1343|-0.0157||||||The difference in proportions of patients with plasma HIV-1 RNA \<50 copies/mL at Week 48 between the \[MVC+DRV/r\] and the \[FTC/TDF+DRV/r\] treatment arms, with two-sided 95% confidence interval, is shown for those patients who were R5 by genotype (including all who were originally randomized to ESTA and were R5 by genotype upon retesting), via the maximum likelihood (ML) method.||-0.0157|-0.1343|
70899470|NCT01345630|141288092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.975|TWO_SIDED|95.0|-24.4|23.6|||ANCOVA|||Results were from an ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.||23.6|-24.4|0.9750
70899471|NCT01345630|141288093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.1|-1.5|||ANCOVA|||Results were from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.||-1.5|-3.1|<0.0001
70899472|NCT01345630|141288094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|127.7|||<|0.0001|TWO_SIDED|95.0|76.5|178.8|||ANCOVA|||Results were from ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.||178.8|76.5|<0.0001
70899473|NCT01345630|141288095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|||<|0.0001|TWO_SIDED|95.0|1.1|3.1|||ANCOVA|||Results were from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.||3.1|1.1|<0.0001
70899474|NCT01345630|141288096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|||<|0.0001|TWO_SIDED|95.0|-0.15|-0.07|||ANCOVA|||Results are from an ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.||-0.07|-0.15|<0.0001
70899475|NCT01345630|141288097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|75.861||||0.8379|TWO_SIDED|95.0|-658.181|809.903|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||809.903|-658.181|0.8379
70899476|NCT01345630|141288098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031||||0.3376|TWO_SIDED|95.0|-0.033|0.094|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||0.094|-0.033|0.3376
70899477|NCT01345630|141288099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.014||||0.0043|TWO_SIDED|95.0|0.004|0.023|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||0.023|0.004|0.0043
70899478|NCT01345630|141288100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008||||0.2273|TWO_SIDED|95.0|-0.005|0.022|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||0.022|-0.005|0.2273
70899479|NCT01345630|141288101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005||||0.4188|TWO_SIDED|95.0|-0.007|0.018|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||0.018|-0.007|0.4188
70899480|NCT01345630|141288102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.12||||0.1722|TWO_SIDED|95.0|-5.17|0.94|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||0.94|-5.17|0.1722
70899481|NCT01345630|141288103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-126.78||||0.0071|TWO_SIDED|95.0|-218.34|-35.23|||ANCOVA|||Results are from an ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||-35.23|-218.34|0.0071
70899482|NCT01787097|141288131|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
70899483|NCT00949884|141288136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|0.63|<|0.0001|TWO_SIDED|95.0|-3.8|-1.3|||ANCOVA|The ANCOVA model included treatment as a fixed effect and the baseline DBP as a covariate.||Null hypothesis was that there was no difference in change in seated diastolic blood pressure from baseline to end of treatment. Sample size of 900, this study had 90% power to detect a true difference in mean change from baseline in mean trough SDBP of 2.0 mmHg for Combined Olmesartan vs Losartan.||-1.3|-3.8|<0.0001
70899484|NCT00949884|141288137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6|STANDARD_ERROR_OF_MEAN|0.88|<|0.0001|TWO_SIDED|95.0|-5.3|-1.8|||ANCOVA|The ANCOVA model included treatment as a fixed effect and baseline SSBP as a covariate.||||-1.8|-5.3|<0.0001
70899485|NCT00949884|141288138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|0.99||0.0001|TWO_SIDED|95.0|-5.8|-1.9|||ANCOVA|The ANCOVA model included treatment as a fixed effect and baseline SSBP as a covariate.||||-1.9|-5.8|0.0001
70899486|NCT00949884|141288139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.58|<|0.0001|TWO_SIDED|95.0|-3.8|-1.5|||ANCOVA|ANCOVA model included treatment as a fixed effect and baseline blood pressure value as a covariate.||||-1.5|-3.8|<0.0001
70899487|NCT00949884|141288141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.55||0.1121|TWO_SIDED|95.0|-2.0|0.2|||ANCOVA|Treatment as a fixed effect and the seated cuff diastolic blood pressure value at week 4 (with last observation carried forward) as a covariate.||||0.2|-2.0|0.1121
70899488|NCT00949884|141288141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.54||0.0783|TWO_SIDED|95.0|-2.0|0.1|||ANCOVA|Treatment as a fixed effect and the seated cuff diastolic blood pressure value at week 4 (with last observation carried forward) as a covariate.||||0.1|-2.0|0.0783
70899489|NCT00949884|141288142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.92||0.2312|TWO_SIDED|95.0|-2.9|0.7|||ANCOVA|Treatment as a fixed effect and the seated cuff diastolic blood pressure value at week 4 (with last observation carried forward) as a covariate.||||0.7|-2.9|0.2312
70899490|NCT00949884|141288142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.9||0.0979|TWO_SIDED|95.0|-3.2|0.3|||ANCOVA|Treatment as a fixed effect and the seated cuff diastolic blood pressure value at week 4 (with last observation carried forward) as a covariate.||||0.3|-3.2|0.0979
70899491|NCT00949884|141288143|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<140 mmHg||||<0.0001
70899492|NCT00949884|141288143|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<140 mmHg||||0.0001
70899493|NCT00949884|141288143|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<135 mmHg||||<0.0001
70899494|NCT00949884|141288143|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<135 mmHg||||<0.0001
70899495|NCT00949884|141288143|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<130 mmHg||||<0.0001
70899496|NCT00949884|141288143|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<130 mmHg||||<0.0001
70899497|NCT00949884|141288143|SUPERIORITY_OR_OTHER|||||||0.2755||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<120 mmHg||||0.2755
70899498|NCT00949884|141288143|SUPERIORITY_OR_OTHER|||||||0.1646||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<120 mmHg||||0.1646
70899499|NCT00949884|141288143|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<90 mmHg||||<0.0001
70899500|NCT00949884|141288143|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<90 mmHg||||<0.0001
70899501|NCT00949884|141288143|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.|Regression, Logistic|||Percentage of participants achieving diastolic blood pressure goal of \<85 mmHg||||<0.0001
70899502|NCT00949884|141288143|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<85 mmHg||||<0.0001
70899503|NCT00949884|141288143|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<80 mmHg||||0.0010
70899504|NCT00949884|141288143|SUPERIORITY_OR_OTHER|||||||0.0011||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<80 mmHg||||0.0011
70899505|NCT00949884|141288143|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<140/90 mmHg||||<0.0001
70899506|NCT00949884|141288143|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<140/90 mmHg||||<0.0001
70899507|NCT00949884|141288143|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<135/80 mmHg||||0.0005
70899508|NCT00949884|141288143|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<135/80 mmHg||||0.0004
70899509|NCT00949884|141288143|SUPERIORITY_OR_OTHER|||||||0.0023||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<130/80 mmHg||||0.0023
70899510|NCT00949884|141288143|SUPERIORITY_OR_OTHER|||||||0.0012||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<130/80 mmHg||||0.0012
70899511|NCT00949884|141288144|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<140 mmHg||||<0.0001
70899512|NCT00949884|141288144|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<140 mmHg||||<0.0001
70899513|NCT00949884|141288144|SUPERIORITY_OR_OTHER|||||||0.0009||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<135 mmHg||||0.0009
70899514|NCT00949884|141288144|SUPERIORITY_OR_OTHER|||||||0.0007||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<135 mmHg||||0.0007
70899515|NCT00949884|141288144|SUPERIORITY_OR_OTHER|||||||0.0347||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<130 mmHg||||0.0347
70899516|NCT00949884|141288144|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<130 mmHg||||0.0280
70899517|NCT00949884|141288144|SUPERIORITY_OR_OTHER|||||||0.0519||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<120 mmHg||||0.0519
70899518|NCT00949884|141288144|SUPERIORITY_OR_OTHER|||||||0.0605||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<120 mmHg||||0.0605
70899519|NCT00949884|141288144|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<90 mmHg||||0.0001
70899520|NCT00949884|141288144|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<90 mmHg||||0.0003
70899521|NCT00949884|141288144|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<85 mmHg||||0.0070
70899522|NCT00949884|141288144|SUPERIORITY_OR_OTHER|||||||0.0066||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<85 mmHg||||0.0066
70899523|NCT00949884|141288144|SUPERIORITY_OR_OTHER|||||||0.0061||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<80 mmHg||||0.0061
70899524|NCT00949884|141288144|SUPERIORITY_OR_OTHER|||||||0.0096||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<80 mmHg||||0.0096
70899525|NCT00949884|141288144|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<140/90 mmHg||||<0.0001
70899526|NCT00949884|141288144|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<140/90 mmHg||||<0.0001
70899527|NCT00949884|141288144|SUPERIORITY_OR_OTHER|||||||0.0047||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<135/80 mmHg||||0.0047
70899528|NCT00949884|141288144|SUPERIORITY_OR_OTHER|||||||0.0063||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<135/80 mmHg||||0.0063
70899529|NCT00949884|141288144|SUPERIORITY_OR_OTHER|||||||0.0589||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates||Percentage of participants achieving blood pressure goal of \<130/80 mmHg||||0.0589
70899530|NCT00949884|141288144|SUPERIORITY_OR_OTHER|||||||0.0594||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<130/80 mmHg||||0.0594
70899531|NCT00949884|141288144|SUPERIORITY_OR_OTHER|||||||0.0476||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<120/80 mmHg||||0.0476
70899532|NCT00949884|141288144|SUPERIORITY_OR_OTHER|||||||0.0657||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<120/80 mmHg||||0.0657
70899533|NCT00949884|141288145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.325|TWO_SIDED|95.0|-4.4|1.5|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure as a covariate.||Change from baseline at week 4 in systolic blood pressure.||1.5|-4.4|0.3250
70899534|NCT00949884|141288145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.3491|TWO_SIDED|95.0|-4.4|1.5|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure as a covariate.||Change from baseline at week 4 in systolic blood pressure.||1.5|-4.4|0.3491
70899535|NCT00949884|141288145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.2085|TWO_SIDED|95.0|-3.2|0.7|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 4 in diastolic blood pressure.||0.7|-3.2|0.2085
70899536|NCT00949884|141288145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.2542|TWO_SIDED|95.0|-3.0|0.8|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 4 in diastolic blood pressure.||0.8|-3.0|0.2542
70899537|NCT00949884|141288146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.0209|TWO_SIDED|95.0|-6.6|-0.5|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 8 in systolic blood pressure.||-0.5|-6.6|0.0209
70899538|NCT00949884|141288146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.0186|TWO_SIDED|95.0|-6.6|-0.6|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 8 in systolic blood pressure.||-0.6|-6.6|0.0186
70899539|NCT00949884|141288146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.0175|TWO_SIDED|95.0|-4.5|-0.4|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 8 in diastolic blood pressure.||-0.4|-4.5|0.0175
70899540|NCT00949884|141288146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.0177|TWO_SIDED|95.0|-4.4|-0.4|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 8 in diastolic blood pressure.||-0.4|-4.4|0.0177
70899541|NCT00949884|141288147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.3104|TWO_SIDED|95.0|-5.2|1.7|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime systolic blood pressure||1.7|-5.2|0.3104
70899542|NCT00949884|141288147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.3653|TWO_SIDED|95.0|-4.9|1.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime systolic blood pressure||1.8|-4.9|0.3653
70899543|NCT00949884|141288147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.1197|TWO_SIDED|95.0|-4.1|0.5|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime diastolic blood pressure||0.5|-4.1|0.1197
70899544|NCT00949884|141288147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.1654|TWO_SIDED|95.0|-3.9|0.7|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime diastolic blood pressure||0.7|-3.9|0.1654
70899545|NCT00949884|141288147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.4362|TWO_SIDED|95.0|-4.4|1.9|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime systolic blood pressure||1.9|-4.4|0.4362
70899546|NCT00949884|141288147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.4039|TWO_SIDED|95.0|-4.5|1.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime systolic blood pressure||1.8|-4.5|0.4039
70899547|NCT00949884|141288147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.3929|TWO_SIDED|95.0|-3.1|1.2|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime diastolic blood pressure||1.2|-3.1|0.3929
70899548|NCT00949884|141288147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.4259|TWO_SIDED|95.0|-3.0|1.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime diastolic blood pressure||1.3|-3.0|0.4259
70899549|NCT00949884|141288148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.0396|TWO_SIDED|95.0|-6.8|-0.2|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime systolic blood pressure||-0.2|-6.8|0.0396
70899550|NCT00949884|141288148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.0345|TWO_SIDED|95.0|-6.8|-0.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime systolic blood pressure||-0.3|-6.8|0.0345
70899551|NCT00949884|141288148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.0324|TWO_SIDED|95.0|-4.8|-0.2|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime diastolic blood pressure||-0.2|-4.8|0.0324
70899552|NCT00949884|141288148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.0363|TWO_SIDED|95.0|-4.7|-0.2|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime diastolic blood pressure||-0.2|-4.7|0.0363
70899553|NCT00949884|141288148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.0988|TWO_SIDED|95.0|-6.5|0.6|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime systolic blood pressure||0.6|-6.5|0.0988
70899554|NCT00949884|141288148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.0926|TWO_SIDED|95.0|-6.4|0.5|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime systolic blood pressure||0.5|-6.4|0.0926
70899555|NCT00949884|141288148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.09|TWO_SIDED|95.0|-4.5|0.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime diastolic blood pressure||0.3|-4.5|0.0900
70899556|NCT00949884|141288148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.0942|TWO_SIDED|95.0|-4.4|0.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime diastolic blood pressure||0.3|-4.4|0.0942
70899557|NCT00949884|141288149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.3229|TWO_SIDED|95.0|-5.4|1.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour systolic blood pressure||1.8|-5.4|0.3229
70899558|NCT00949884|141288149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.3863|TWO_SIDED|95.0|-5.1|2.0|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour systolic blood pressure||2.0|-5.1|0.3863
70899559|NCT00949884|141288149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.1277|TWO_SIDED|95.0|-4.5|0.6|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour diastolic blood pressure||0.6|-4.5|0.1277
70899560|NCT00949884|141288149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.1799|TWO_SIDED|95.0|-4.3|0.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour diastolic blood pressure||0.8|-4.3|0.1799
70899561|NCT00949884|141288149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.2708|TWO_SIDED|95.0|-5.1|1.4|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour systolic blood pressure||1.4|-5.1|0.2708
70899562|NCT00949884|141288149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.3133|TWO_SIDED|95.0|-5.0|1.6|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour systolic blood pressure||1.6|-5.0|0.3133
70899563|NCT00949884|141288149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.1621|TWO_SIDED|95.0|-3.9|0.7|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour diastolic blood pressure||0.7|-3.9|0.1621
70899564|NCT00949884|141288149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.2314|TWO_SIDED|95.0|-3.7|0.9|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour diastolic blood pressure||0.9|-3.7|0.2314
70899565|NCT00949884|141288149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.2461|TWO_SIDED|95.0|-5.0|1.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour systolic blood pressure||1.3|-5.0|0.2461
70899566|NCT00949884|141288149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.2558|TWO_SIDED|95.0|-5.0|1.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour systolic blood pressure||1.3|-5.0|0.2558
70899567|NCT00949884|141288149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.17|TWO_SIDED|95.0|-3.8|0.7|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour diastolic blood pressure||0.7|-3.8|0.1700
70899568|NCT00949884|141288149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.2011|TWO_SIDED|95.0|-3.7|0.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour diastolic blood pressure||0.8|-3.7|0.2011
70899569|NCT00949884|141288150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.1895|TWO_SIDED|95.0|-7.0|1.4|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour systolic blood pressure||1.4|-7.0|0.1895
70899570|NCT00949884|141288150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.2701|TWO_SIDED|95.0|-6.5|1.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour systolic blood pressure||1.8|-6.5|0.2701
70899571|NCT00949884|141288150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.1328|TWO_SIDED|95.0|-5.2|0.7|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour diastolic blood pressure||0.7|-5.2|0.1328
70899572|NCT00949884|141288150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.1778|TWO_SIDED|95.0|-4.9|0.9|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour diastolic blood pressure||0.9|-4.9|0.1778
70899573|NCT00949884|141288150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.062|TWO_SIDED|95.0|-7.3|0.2|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour systolic blood pressure||0.2|-7.3|0.0620
70899574|NCT00949884|141288150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1||||0.1011|TWO_SIDED|95.0|-6.9|0.6|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour systolic blood pressure||0.6|-6.9|0.1011
70899575|NCT00949884|141288150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.0249|TWO_SIDED|95.0|-5.6|-0.4|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour diastolic blood pressure||-0.4|-5.6|0.0249
70899576|NCT00949884|141288150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.0497|TWO_SIDED|95.0|-5.2|0.0|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour diastolic blood pressure||0.0|-5.2|0.0497
70899577|NCT00949884|141288150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.0552|TWO_SIDED|95.0|-7.1|0.1|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour systolic blood pressure||0.1|-7.1|0.0552
70899578|NCT00949884|141288150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2||||0.0767|TWO_SIDED|95.0|-6.8|0.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour systolic blood pressure||0.3|-6.8|0.0767
70899579|NCT00949884|141288150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.0279|TWO_SIDED|95.0|-5.3|-0.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour diastolic blood pressure||-0.3|-5.3|0.0279
70899580|NCT00949884|141288150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.0434|TWO_SIDED|95.0|-5.0|-0.1|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour diastolic blood pressure||-0.1|-5.0|0.0434
70899581|NCT00949884|141288151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3||||0.0009|TWO_SIDED|95.0|-6.8|-1.8|||ANCOVA|Treatment is a fixed effect and baseline blood pressure is a covariate.||Diastolic blood pressure||-1.8|-6.8|0.0009
70899582|NCT00949884|141288151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6|||<|0.0001|TWO_SIDED|95.0|-12.5|-4.7|||ANCOVA|Treatment is a fixed effect and baseline blood pressure is a covariate.||Systolic blood pressure||-4.7|-12.5|<0.0001
70899583|NCT00944658|141288152|SUPERIORITY|||||||0.139|||||||ANCOVA|||||||0.139
70899584|NCT00944658|141288153|SUPERIORITY|||||||0.58|||||||ANCOVA|||||||0.58
70899585|NCT00944658|141288154|SUPERIORITY|||||||0.108|||||||ANCOVA|Rank Ancova||||||0.108
70899586|NCT00297115|141288166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|58.0|STANDARD_ERROR_OF_MEAN|9.0|<|0.0001|TWO_SIDED|95.0|41.0|75.0||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).||||75|41|<0.0001
70899587|NCT00297115|141288167|SUPERIORITY_OR_OTHER||Rate ratio|0.815|STANDARD_ERROR_OF_MEAN|0.057||0.0035|TWO_SIDED|95.0|0.71|0.935||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|Poisson regression|||||0.935|0.710|0.0035
70899588|NCT00297115|141288168|SUPERIORITY_OR_OTHER||Mean Difference (Net)|61.0|STANDARD_ERROR_OF_MEAN|9.0|<|0.0001|TWO_SIDED|95.0|44.0|79.0||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).||||79|44|<0.0001
70899589|NCT00297115|141288169|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.213|STANDARD_ERROR_OF_MEAN|0.35||0.5028|TWO_SIDED|95.0|0.689|2.137||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|Cox proportional hazards regression||The statistical analysis is based on the ITT Analysis Set (n= 772 in the roflumilast group, n= 796 in the placebo group).|||2.137|0.689|0.5028
70899590|NCT00297115|141288170|SUPERIORITY_OR_OTHER||Mean Difference calculated as ratio|1.0593||||0.3627|TWO_SIDED|95.0|0.9356|1.1994||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|ANCOVA model including last observation carried forward (LOCF) method||||1.1994|0.9356|0.3627
70899591|NCT00297115|141288171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.286|STANDARD_ERROR_OF_MEAN|0.104||0.0059|TWO_SIDED|95.0|0.082|0.489||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).||||0.489|0.082|0.0059
70899592|NCT02472652|141288183|OTHER||change in prolactin|30.0|||||TWO_SIDED|||||||||||||
70899593|NCT05067439|141288197|OTHER||Ratio of Adjusted Geometric Means|288.81|||||TWO_SIDED|90.0|240.56|346.73||||||Omeprazole 10 mg was Reference and abrocitinib 200 mg + omeprazole 10 mg was Test. Natural log-transformed AUCinf was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect and estimates of the adjusted mean differences (Test-Reference) and 90% CIs were obtained. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI.||346.73|240.56|
70899594|NCT05067439|141288198|OTHER||Ratio of Adjusted Geometric Means|139.59|||||TWO_SIDED|90.0|121.98|159.74||||||Caffeine 100 mg was Reference and abrocitinib 200 mg + caffeine 100 mg was Test. Natural log-transformed AUCinfCR was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect and estimates of the adjusted mean differences (Test-Reference) and 90% CIs were obtained. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI.||159.74|121.98|
70899595|NCT05067439|141288199|OTHER||Ratio of Adjusted Geometric Means|110.1|||||TWO_SIDED|90.0|103.45|117.17||||||Efavirenz 50 mg was Reference and abrocitinib 200 mg + efavirenz 50 mg was Test. Natural log-transformed AUClastCR was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect and estimates of the adjusted mean differences (Test-Reference) and 90% CIs were obtained. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI.||117.17|103.45|
70899596|NCT02323646|141288204|SUPERIORITY|||||||0.0019|||||||Fisher Exact|||||||0.0019
70899597|NCT02323646|141288204|SUPERIORITY|||||||0.0063|||||||Fisher Exact|||||||0.0063
70899598|NCT02323646|141288205|SUPERIORITY|||||||0.0237|||||||Fisher Exact|||||||0.0237
70899599|NCT02323646|141288205|SUPERIORITY|||||||0.0272|||||||Fisher Exact|||||||0.0272
70899600|NCT02323646|141288206|SUPERIORITY|||||||0.0145|||||||Wilcoxon Rank-Sum Test.|||Percentage change in the last value on drug Course 1.||||0.0145
70899601|NCT02323646|141288206|SUPERIORITY|||||||0.0662|||||||Wilcoxon Rank-Sum Test.|||Percentage change in the last value on drug Course 1.||||0.0662
70899602|NCT02323646|141288206|SUPERIORITY|||||||0.0061|||||||Wilcoxon Rank-Sum Test|||Percentage change in the last value on drug Course 2.||||0.0061
70899603|NCT02323646|141288206|SUPERIORITY|||||||0.0296|||||||Wilcoxon Rank-Sum Test|||Percentage change in the last value on drug Course 2.||||0.0296
70899604|NCT02323646|141288207|SUPERIORITY|||||||0.2642|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.2642
70899605|NCT02323646|141288207|SUPERIORITY|||||||0.4383|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.4383
70899606|NCT02323646|141288207|SUPERIORITY|||||||0.5333|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.5333
70899607|NCT02323646|141288207|SUPERIORITY|||||||0.8791|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.8791
70899608|NCT02323646|141288207|SUPERIORITY|||||||0.3666|||||||Wilcoxon Rank-Sum Test|||Percentage Change: Course 2, Week 24 Follow-up||||0.3666
70899609|NCT02323646|141288207|SUPERIORITY|||||||0.345|||||||Wilcoxon Rank-Sum Test|||Percentage Change: Course 2, Week 24 Follow-up||||0.3450
70899610|NCT02323646|141288208|SUPERIORITY|||||||0.0473|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.0473
70899611|NCT02323646|141288208|SUPERIORITY|||||||0.0191|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.0191
70899612|NCT02323646|141288208|SUPERIORITY|||||||0.0749|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.0749
70899613|NCT02323646|141288208|SUPERIORITY|||||||0.0233|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.0233
70899614|NCT02323646|141288208|SUPERIORITY|||||||0.7569|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.7569
70899615|NCT02323646|141288208|SUPERIORITY|||||||0.5399|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.5399
70899616|NCT02323646|141288209|SUPERIORITY|||||||0.1683|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.1683
70899617|NCT02323646|141288209|SUPERIORITY|||||||0.256|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.2560
70899618|NCT02323646|141288209|SUPERIORITY|||||||0.4997|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.4997
70899619|NCT02323646|141288209|SUPERIORITY|||||||0.1334|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.1334
70899620|NCT02323646|141288209|SUPERIORITY|||||||0.0323|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.0323
70899621|NCT02323646|141288209|SUPERIORITY|||||||0.3847|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.3847
70899622|NCT02323646|141288210|SUPERIORITY|||||||0.6356|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.6356
70899623|NCT02323646|141288210|SUPERIORITY|||||||0.9539|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.9539
70899624|NCT02323646|141288210|SUPERIORITY|||||||0.5219|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.5219
70899625|NCT02323646|141288210|SUPERIORITY|||||||0.2678|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.2678
70899626|NCT02323646|141288210|SUPERIORITY|||||||0.3086|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.3086
70899627|NCT02323646|141288210|SUPERIORITY|||||||0.3847|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.3847
70899628|NCT02323646|141288211|SUPERIORITY|||||||0.8393|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.8393
70899629|NCT02323646|141288211|SUPERIORITY|||||||0.1361|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.1361
70899630|NCT02323646|141288211|SUPERIORITY|||||||0.0382|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.0382
70899631|NCT02323646|141288211|SUPERIORITY|||||||0.6273|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.6273
70899632|NCT02323646|141288211|SUPERIORITY|||||||0.8237|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.8237
70899633|NCT02323646|141288211|SUPERIORITY|||||||0.137|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.1370
70899634|NCT02323646|141288212|SUPERIORITY|||||||0.7949|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.7949
70899635|NCT02323646|141288212|SUPERIORITY|||||||0.1928|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.1928
70899636|NCT02323646|141288212|SUPERIORITY|||||||1|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||1.0000
70899637|NCT02323646|141288212|SUPERIORITY|||||||0.392|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.3920
70899638|NCT02323646|141288212|SUPERIORITY|||||||0.541|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.5410
70899639|NCT02323646|141288212|SUPERIORITY|||||||0.4602|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.4602
70899640|NCT02323646|141288213|SUPERIORITY|||||||0.9536|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.9536
70899641|NCT02323646|141288213|SUPERIORITY|||||||0.1355|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.1355
70899642|NCT02323646|141288213|SUPERIORITY|||||||0.9396|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.9396
70899643|NCT02323646|141288213|SUPERIORITY|||||||0.9102|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.9102
70899644|NCT02323646|141288213|SUPERIORITY|||||||0.6266|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.6266
70899645|NCT02323646|141288213|SUPERIORITY|||||||0.9302|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.9302
70899646|NCT02323646|141288214|SUPERIORITY|||||||0.817|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.8170
70899647|NCT02323646|141288214|SUPERIORITY|||||||0.8177|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.8177
70899648|NCT02323646|141288214|SUPERIORITY|||||||0.3167|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.3167
70899649|NCT02323646|141288214|SUPERIORITY|||||||0.5503|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.5503
70899650|NCT02323646|141288214|SUPERIORITY|||||||0.6929|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.6929
70899651|NCT02323646|141288214|SUPERIORITY|||||||0.726|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.7260
70899652|NCT02323646|141288215|SUPERIORITY|||||||0.3896|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.3896
70899653|NCT02323646|141288215|SUPERIORITY|||||||0.1358|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.1358
70899654|NCT02323646|141288215|SUPERIORITY|||||||0.7903|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.7903
70899655|NCT02323646|141288215|SUPERIORITY|||||||0.8206|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.8206
70899656|NCT02323646|141288215|SUPERIORITY|||||||0.7891|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.7891
70899657|NCT02323646|141288215|SUPERIORITY|||||||0.401|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.4010
70899658|NCT02323646|141288216|SUPERIORITY|||||||0.0294|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.0294
70899659|NCT02323646|141288216|SUPERIORITY|||||||0.1934|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.1934
70899660|NCT02323646|141288216|SUPERIORITY|||||||0.0442|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.0442
70899661|NCT02323646|141288216|SUPERIORITY|||||||0.8314|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.8314
70899662|NCT05131165|141288242|SUPERIORITY|||||||0.056||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.056
70899663|NCT05131165|141288242|SUPERIORITY|||||||0.062||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.062
70899664|NCT05131165|141288243|SUPERIORITY|||||||0.364||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.364
70899665|NCT05131165|141288243|SUPERIORITY|||||||0.409||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.409
70899666|NCT05131165|141288244|SUPERIORITY|||||||0.158||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.158
70899667|NCT05131165|141288244|SUPERIORITY|||||||0.017||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.017
70899668|NCT05131165|141288245|SUPERIORITY|||||||0.654||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.654
70899669|NCT05131165|141288245|SUPERIORITY|||||||0.035||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.035
70899670|NCT05131165|141288247|SUPERIORITY|||||||0.5468|||||||t-test, 2 sided|||The analyses compared the change in viral suppression status of the participants from baseline to month 9. For each participant, we derived the change in viral suppression status by subtracting two binary variables - one indicating whether the participant was virally suppressed at baseline (based on their chart records from around 3 months prior to baseline) and the other indicating whether the participant was virally suppressed at around month 9 of the study.||||0.5468
70899671|NCT05131165|141288247|SUPERIORITY|||||||0.5255|||||||t-test, 2 sided|||The analyses compared the change in viral suppression status of the participants from baseline to month 9. For each participant, we derived the change in viral suppression status by subtracting two binary variables - one indicating whether the participant was virally suppressed at baseline (based on their chart records from around 3 months prior to baseline) and the other indicating whether the participant was virally suppressed at around month 9 of the study.||||0.5255
70899672|NCT02298361|141288264|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.76|||||TWO_SIDED|95.0|1.6|1.93|||Generalized estimating equation|GEE model clustered by clinic, adjusted for demographics, number of visits, new/established patient at first visit, and household factors.|Adjusted odds of gaining Medicaid: intervention patients (numerator) relative to within-clinic comparison patients (denominator)|||1.93|1.60|
70899673|NCT02298361|141288264|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.28|||||TWO_SIDED|95.0|1.91|2.72|||Generalized estimating equation|GEE model clustered by clinic, adjusted for demographics, number of visits, new/established patient at first visit, and household factors.|Adjusted odds of gaining Medicaid: intervention patients (numerator) relative to control clinic comparison patients (denominator)|||2.72|1.91|
70899674|NCT02298361|141288265|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.53|0.94|||Generalized estimating equation|GEE model clustered by clinic, adjusted for demographics, number of visits, new/established patient at first visit, and household factors.|Adjusted odds of losing Medicaid: intervention patients (numerator) relative to within-clinic comparison patients (denominator)|||0.94|0.53|
70899675|NCT02298361|141288265|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55|||||TWO_SIDED|95.0|0.45|0.67|||Generalized estimating equation|GEE model clustered by clinic, adjusted for demographics, number of visits, new/established patient at first visit, and household factors.|Adjusted odds of losing Medicaid: intervention patients (numerator) relative to control clinic comparison patients (denominator)|||0.67|0.45|
70899676|NCT02459262|141288268|OTHER|ANOVA repeated measures: In-transformed antibody concentrations as dependent variable; dose level, time, presence of adjuvant and dose\*time interaction as fixed effects; subjects as random effects||||||0.0193||||||Adjuvant effect at Day 85, the primary immunological endpoint|ANOVA|Adjuvant effect, with higher antibody concentration values after all dose levels of vaccine was significant at all time points (D29, D43, D57, Day 85)||The objectives for Part A were to evaluate the effect of adjuvant and to inform the selection of dose levels for Part B. The study was not powered for inter-group comparisons.||||0.0193
70899677|NCT02459262|141288269|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
70899678|NCT02459262|141288270|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
70899679|NCT05168579|141288273|SUPERIORITY||Odds Ratio (OR)|13.8|||<|0.001|TWO_SIDED|95.0|2.76|69.6|||Mixed Models Analysis|||||69.6|2.76|<0.001
70899680|NCT01242748|141288275|NON_INFERIORITY_OR_EQUIVALENCE|Degarelix was considered to be non-inferior to goserelin with regard to the hazard ratio of PSA PFS failure rates as the upper limit of the two-sided 95% CI of the adjusted hazard ratio was less than the non-inferiority margin of 1.33.|Hazard Ratio (HR)|0.774||||0.1589|TWO_SIDED|95.0|0.542|1.106|||Cox proportional hazard model|||The hazard ratio of PSA PFS failure rates was estimated using the Cox proportional hazard model with time to PSA PFS failure as dependent and treatment as independent variables and adjusted for baseline PSA category, prostate cancer stage, weight and geographical region. Degarelix was to be considered non-inferior to goserelin if the upper limit of the two-sided 95% confidence interval (CI) of the adjusted hazard ratio was less than or equal to the non-inferiority margin of 1.33.||1.106|0.542|0.1589
70899681|NCT01242748|141288276|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.783||||0.1244|TWO_SIDED|95.0|0.574|1.07|||Cox proportional hazard model|||The hazard ratio was estimated using the Cox proportional hazard model.||1.070|0.574|0.1244
70899682|NCT01242748|141288277|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.856|||||TWO_SIDED|95.0|0.58|1.263||||||The hazard ratio was estimated using the Cox proportional hazard model.||1.263|0.580|
70899683|NCT01242748|141288278|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.511||||0.0005|TWO_SIDED|95.0|1.739|7.09|||Cox proportional hazard model|||The hazard ratio was estimated using the Cox proportional hazard model.||7.090|1.739|0.0005
70899684|NCT01242748|141288279|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.739||||0.143|TWO_SIDED|95.0|0.493|1.108|||Cox proportional hazard model|||The hazard ratio was estimated using the Cox proportional hazard model.||1.108|0.493|0.143
70899685|NCT01242748|141288280|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.595||||0.2212|TWO_SIDED|95.0|0.259|1.368|||Cox proportional hazard model|||The hazard ratio was estimated using the Cox proportional hazard model.||1.368|0.259|0.2212
70899686|NCT00840801|141288283|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A stratified score test was used to test the non-inferiority with a margin of -10% at 2.5% type I error (one-sided).|||||<|0.001|||||||Stratified score test|||Non-inferiority Test on Seropositive Response Rate||||<0.001
70899687|NCT02416492|141288305|SUPERIORITY||Least Square (LS) Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|2.9||0.0401|TWO_SIDED|95.0||||MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|||Adjusted LS mean and treatment group difference in change from baseline at Week 24 were modeled using an MMRM including the following variables: treatment, visit, treatment by visit interaction, baseline FMMS score, baseline FMMS score by visit interaction, GOS-E score at screening, and GOS-E score at screening by visit interaction.||||0.0401
70899688|NCT02416492|141288306|SUPERIORITY||Least Square (LS) Mean Difference|-0.7||||0.1655|TWO_SIDED|95.0|-1.7|0.3||MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|||Adjusted LS mean and treatment group difference in change from baseline at Week 24 were modeled using an MMRM including the following variables: treatment, visit, treatment by visit interaction, baseline FMMS score, baseline FMMS score by visit interaction, GOS-E score at screening, and GOS-E score at screening by visit interaction.||0.3|-1.7|0.1655
70899689|NCT02416492|141288307|SUPERIORITY||Least Square (LS) Mean Difference|2.7||||0.3398|TWO_SIDED|95.0|-2.9|8.3|||Mixed Models Analysis|MMRM included treatment, visit, baseline endpoints \& GOS-E scores, baseline endpoints \& GOS-E by visit interaction, treatment-by-visit interaction||Adjusted LS mean and treatment group difference in change from baseline at Week 24 were modeled using an MMRM including the following variables: treatment, visit, treatment by visit interaction, baseline FMMS score, baseline FMMS score by visit interaction, GOS-E score at screening, and GOS-E score at screening by visit interaction.||8.3|-2.9|0.3398
70899690|NCT02416492|141288308|SUPERIORITY||Least Square (LS) Mean Difference|-2.6||||0.8974|TWO_SIDED|95.0|-42.2|37.1||MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|||Adjusted LS mean and treatment group difference in change from baseline at Week 24 were modeled using an MMRM including the following variables: treatment, visit, treatment by visit interaction, baseline FMMS score, baseline FMMS score by visit interaction, GOS-E score at screening, and GOS-E score at screening by visit interaction.||37.1|-42.2|0.8974
70899691|NCT02416492|141288309|SUPERIORITY||Least Square (LS) Mean Difference|-0.49||||0.8534|TWO_SIDED|95.0|-5.77|4.8||MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|MMRM included treatment, visit, baseline endpoints \& GOS-E scores, baseline endpoints \& GOS-E by visit interaction, treatment-by-visit interaction||Change from Baseline in NeuroQOL Upper Extremity Function T Score at Week 24||4.80|-5.77|0.8534
70899692|NCT02416492|141288309|SUPERIORITY||Least Square (LS) Mean Difference|0.41||||0.8443|TWO_SIDED|95.0|-3.78|4.6||MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|MMRM included treatment, visit, baseline endpoints \& GOS-E scores, baseline endpoints \& GOS-E by visit interaction, treatment-by-visit interaction||Change from Baseline in NeuroQOL Lower Extremity Function T Score at Week 24||4.60|-3.78|0.8443
70899693|NCT00508404|141288311|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.12|||||TWO_SIDED|95.0|1.02|4.45|||||The odds ratio is defined as the odds of having an objective response in the KRAS Wild-type group relative to the odds in the KRAS Mutant group.|||4.45|1.02|
70899694|NCT00508404|141288312|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.86|||||TWO_SIDED|95.0|0.88|3.93|||||The odds ratio is defined as the odds of having an objective response in the KRAS Wild-type group relative to the odds in the KRAS Mutant group.|||3.93|0.88|
70899695|NCT00508404|141288313|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.3|3.89|||||The odds ratio is defined as the odds of having an objective response in the KRAS Wild-type group relative to the odds in the KRAS Mutant group.|||3.89|0.30|
70899696|NCT00508404|141288314|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.283|||||TWO_SIDED|95.0|0.13|0.614|||||Hazard ratio is presented as Wild-type KRAS:Mutant KRAS. A value \< 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.|||0.614|0.130|
70899697|NCT00508404|141288315|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.642|||||TWO_SIDED|95.0|0.99|2.721|||||Hazard ratio is presented as Wild-type KRAS:Mutant KRAS. A value \< 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.|||2.721|0.990|
70899698|NCT00508404|141288316|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.464|||||TWO_SIDED|95.0|0.306|0.703|||||Hazard ratio presented as Wild-type KRAS:Mutant KRAS. A value \< 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.|||0.703|0.306|
70899699|NCT00508404|141288317|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.395|||||TWO_SIDED|95.0|0.252|0.618|||||Hazard ratio is presented as Wild-type KRAS:Mutant KRAS. A value \< 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.|||0.618|0.252|
70899700|NCT00508404|141288318|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.756|||||TWO_SIDED|95.0|0.4|1.43|||||Hazard ratio is presented as Wild-type KRAS:Mutant KRAS. A value \< 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.|||1.430|0.400|
70899701|NCT00508404|141288319|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.503|1.002|||||Hazard ratio is presented as Wild-type KRAS:Mutant KRAS. A value \< 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.|||1.002|0.503|
70899702|NCT00508404|141288321|SUPERIORITY_OR_OTHER_LEGACY||Difference in rates|8.34|||||TWO_SIDED|95.0|-4.01|19.08||||||||19.08|-4.01|
70899703|NCT01591382|141288322|SUPERIORITY_OR_OTHER|||||||0.0241||||||A P-value of \<0.05 was indicative of statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.0241
70899704|NCT01591382|141288323|SUPERIORITY_OR_OTHER|||||||0.4102||||||A P-value of \<0.05 was indicative of statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.4102
70899705|NCT01591382|141288324|SUPERIORITY_OR_OTHER|||||||0.1085||||||A P-value of \<0.05 was indicative of statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.1085
70899706|NCT01591382|141288325|SUPERIORITY_OR_OTHER|||||||0.748|||||||Wilcoxon (Mann-Whitney)|||||||0.7480
70899707|NCT03170375|141288327|SUPERIORITY|||||||0.28|||||||Regression, Linear|adjusted for baseline carotid-femoral pulse wave velocity||||||0.28
70899708|NCT03170375|141288328|SUPERIORITY|||||||0.6|||||||Regression, Linear|adjusted for baseline left ventricular mass index||||||0.60
70899709|NCT03170375|141288329|SUPERIORITY|||||||0.27|||||||Regression, Linear|adjusted for baseline global left ventricular longitudinal strain||||||0.27
70899710|NCT03170375|141288330|SUPERIORITY|||||||0.03|||||||Regression, Linear|adjusted for baseline carotid-femoral pulse wave velocity||||||0.03
70899711|NCT03170375|141288334|SUPERIORITY|||||||0.47|||||||generalized estimating equations|Model includes time (baseline, phase 2 month 1, phase 2 month 6), randomization assignment, and time x randomization assignment||||||0.47
70899712|NCT03170375|141288335|SUPERIORITY|||||||0.28|||||||generalized estimating equation|Model includes time (baseline, phase 2 month 1, phase 2 month 6), randomization assignment, and time x randomization assignment||||||0.28
70899713|NCT03170375|141288336|SUPERIORITY|||||||0.43|||||||generalized estimating equations|Model includes time (baseline, phase 2 month 1, phase 2 month 6), randomization assignment, and time x randomization assignment||||||0.43
70899714|NCT03170375|141288337|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||||||0.94
70899715|NCT03170375|141288338|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||||||0.90
70899716|NCT00855062|141288339|SUPERIORITY_OR_OTHER||Slope|-0.026|STANDARD_ERROR_OF_MEAN|0.248||0.37|TWO_SIDED|95.0|-0.512|0.46||The p-value was not adjusted for multiple comparisons.|Regression, Linear|||"The null hypothesis was that the 24-week changes of U NP Sum between the minocycline and placebo groups are the same.~The sample size calculation showed that 100 (50 participants in each group) were required to detect the clinically meaningful difference of 0.5 with 85% power, 0.05 Type I error, two-sample and two-sided test."||0.460|-0.512|0.370
70899717|NCT00855062|141288341|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.053||||0.613|TWO_SIDED|95.0|0.043|0.062||The p-value is not adjusted for multiple comparisons.|Fisher Exact|||"The null hypothesis is that the percentage of participants feeling better in the minocycline group after 24 week treatment is the same as the one in the placebo group."||0.062|0.043|0.613
70899718|NCT00855062|141288342|SUPERIORITY_OR_OTHER|||||||0.661||95.0||||The p-value is not adjusted for multiple comparisons.|Log Rank|||The null hypothesis is that the survival curve for the first Grade ≥ 2 toxicity and/or sign and symptoms in the minocycline group is the same as the one in the placebo group.||||0.661
70899719|NCT00855062|141288343|SUPERIORITY_OR_OTHER|||||||0.941||95.0||||The p-value is not adjusted for multiple comparisons.|Log Rank|||The null hypothesis is that the 48-week survival curve for the first Grade ≥ 2 toxicity and/or sign and symptoms in the minocycline group is the same as the one in the placebo group.||||0.941
70899720|NCT00855062|141288344|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.11|STANDARD_ERROR_OF_MEAN|17.63||0.647|TWO_SIDED|95.0|-27.23|43.45||The p-value is not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the baseline CD4 counts.||The null hypothesis is that the mean 24-week change of CD4 cell counts in the minocycline group is the same as the one in the placebo group.||43.45|-27.23|0.647
70899721|NCT00855062|141288345|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.77|STANDARD_ERROR_OF_MEAN|32.51||0.813|TWO_SIDED|95.0|-59.07|74.6||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the baseline CD4 counts.||The null hypothesis is that the mean 48-week change in CD4 cell counts in the minocycline group is the same as the one in the placebo group.||74.60|-59.07|0.813
70899722|NCT00855062|141288346|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28|STANDARD_ERROR_OF_MEAN|0.82||0.764||95.0|0.26|6.34||The p-value is not adjusted for multiple comparisons.|Regression, Logistic|"The model was not adjusted for any covariate (due to small number of being better in both groups."||"The null hypothesis is that the percentage of being better at week 24 compared to baseline in the minocycline group is the same as the one in the placebo group."||6.34|0.26|0.764
70899723|NCT00855062|141288347|SUPERIORITY_OR_OTHER|||||||0.766||95.0||||The p-value is not adjusted for multiple comparisons.|Kruskal-Wallis|The chi-square score was 0.024 and the degree of freedom was 1.||The null hypothesis is that the median log10-transformed HIV RNA viral loads in the minocycline group is the same as the one in the placebo group.||||0.766
70899724|NCT00855062|141288348|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.19|STANDARD_ERROR_OF_MEAN|1.79||0.915|TWO_SIDED|95.0|-3.4|3.78||The p-value is not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the baseline CES-D and MSK scores.||The null hypothesis is that the mean 24-week change of CES-D score in the minocycline group is the same as the one in the placebo group.||3.78|-3.40|0.915
70899725|NCT00530062|141288349|OTHER||Difference in adjusted mean|0.946||||0.5595|TWO_SIDED|95.0|-2.293|4.185||Threshold for significance at 0.05 level.|ANCOVA|||The analysis was performed using the mixed-effect analysis of variance with fixed effects of center, sequence, treatment group and period, and random effect of the participant within sequence.||4.185|-2.293|0.5595
70899726|NCT01376323|141288365|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|||||TWO_SIDED|95.0|-0.13|0.6||||||||0.60|-0.13|
70899727|NCT01376323|141288365|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|||||TWO_SIDED|95.0|-0.37|0.35||||||||0.35|-0.37|
70899728|NCT01376323|141288365|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13|||||TWO_SIDED|95.0|-0.49|0.23||||||||0.23|-0.49|
70899729|NCT01376323|141288365|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-0.66|0.06||||||||0.06|-0.66|
70899730|NCT01376323|141288366|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.551|||||TWO_SIDED|95.0|-1.645|0.543|||||Comparison for glucose.|||0.543|-1.645|
70899731|NCT01376323|141288366|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.382|||||TWO_SIDED|95.0|-1.472|0.708|||||Comparison for glucose.|||0.708|-1.472|
70899732|NCT01376323|141288366|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59|||||TWO_SIDED|95.0|-1.696|0.516|||||Comparison for glucose.|||0.516|-1.696|
70899733|NCT01376323|141288366|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.595|||||TWO_SIDED|95.0|-1.669|0.48|||||Comparison for glucose.|||0.480|-1.669|
70899734|NCT01376323|141288366|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.036|||||TWO_SIDED|95.0|-0.042|0.113|||||Comparison for NEFA.|||0.113|-0.042|
70899735|NCT01376323|141288366|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.004|||||TWO_SIDED|95.0|-0.073|0.081|||||Comparison for NEFA.|||0.081|-0.073|
70899736|NCT01376323|141288366|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.021|||||TWO_SIDED|95.0|-0.058|0.099|||||Comparison for NEFA.|||0.099|-0.058|
70899737|NCT01376323|141288366|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.083|||||TWO_SIDED|95.0|-0.16|-0.007|||||Comparison for NEFA.|||-0.007|-0.160|
70899738|NCT01376323|141288368|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|||||TWO_SIDED|95.0|-0.79|0.94||||||||0.94|-0.79|
70899739|NCT01376323|141288368|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04|||||TWO_SIDED|95.0|-0.9|0.82||||||||0.82|-0.90|
70899740|NCT01376323|141288368|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.9|0.85||||||||0.85|-0.90|
70899741|NCT01376323|141288368|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42|||||TWO_SIDED|95.0|-1.27|0.42||||||||0.42|-1.27|
70899742|NCT01376323|141288369|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.27|||||TWO_SIDED|95.0|-48.62|53.16||||||||53.16|-48.62|
70899743|NCT01376323|141288369|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.67|||||TWO_SIDED|95.0|-58.04|42.7||||||||42.70|-58.04|
70899744|NCT01376323|141288369|SUPERIORITY_OR_OTHER||Median Difference (Net)|24.08|||||TWO_SIDED|95.0|-27.75|75.92||||||||75.92|-27.75|
70899745|NCT01376323|141288369|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.09|||||TWO_SIDED|95.0|-52.72|48.53||||||||48.53|-52.72|
70899746|NCT01376323|141288371|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.58|||||TWO_SIDED|95.0|-19.36|16.2||||||||16.20|-19.36|
70899747|NCT01376323|141288371|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.1|||||TWO_SIDED|95.0|-33.0|2.81||||||||2.81|-33.00|
70899748|NCT01376323|141288371|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.09|||||TWO_SIDED|95.0|-32.41|4.23||||||||4.23|-32.41|
70899749|NCT01376323|141288371|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.12|||||TWO_SIDED|95.0|-36.55|-1.68||||||||-1.68|-36.55|
70899750|NCT02634788|141288382|OTHER||LS Mean Difference|81.93|STANDARD_ERROR_OF_MEAN|14.283|<|0.0001|TWO_SIDED|95.0|53.82|110.04|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||110.04|53.82|<0.0001
70899751|NCT02634788|141288382|OTHER||LS Mean Difference|36.18|STANDARD_ERROR_OF_MEAN|14.099||0.0108|TWO_SIDED|95.0|8.43|63.93|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||63.93|8.43|0.0108
70899752|NCT02634788|141288382|OTHER||LS Mean Difference|35.46|STANDARD_ERROR_OF_MEAN|14.02||0.012|TWO_SIDED|95.0|7.86|63.05|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||63.05|7.86|0.0120
70899753|NCT03138733|141288408|NON_INFERIORITY|The non-inferiority hypothesis test was a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two sided 95% CI for the difference in response rates in the mITT population was greater than -15%, the non-inferiority of ceftobiprole to daptomycin therapy was to be concluded.|Adjusted proportion difference|2.0|||||TWO_SIDED|95.0|-7.1|11.1||||||The observed difference in percentage of responders at PTE (ceftobiprole group minus the daptomycin group) were determined and a two-sided 95% confidence interval (CI) for the observed difference was computed, with adjustment for actual stratum (dialysis status and prior antibacterial treatment use). Cochran-Mantel-Haenszel (CMH) weights were used for the stratum weight in the calculation of the CI||11.1|-7.1|
70899754|NCT03138733|141288409|OTHER||Adjusted proportion difference|0.6|||||TWO_SIDED|95.0|-8.3|9.5|||||The two-sided 95% CI was computed using Cochran-Mantel-Haenszel (CMH) weights method adjusted for actual stratum (dialysis status and prior antibacterial treatment use)|||9.5|-8.3|
70899755|NCT03138733|141288410|OTHER||Adjusted proportion difference|5.1|||||TWO_SIDED|95.0|-2.9|13.0|||||The two-sided 95% CI was computed using Cochran-Mantel-Haenszel (CMH) weights method adjusted for actual stratum (dialysis status and prior antibacterial treatment use)|||13|-2.9|
70899756|NCT03138733|141288411|OTHER||Adjusted proportion difference|-0.5|||||TWO_SIDED|95.0|-6.2|5.2|||||The two-sided 95% CI was computed using Cochran-Mantel-Haenszel (CMH) weights method adjusted for actual stratum (dialysis status and prior antibacterial treatment use)|||5.2|-6.2|
70899757|NCT03138733|141288412|OTHER||Adjusted proportion difference|0.1|||||TWO_SIDED|95.0|-4.6|4.8|||||The two-sided 95% CI was computed using Cochran-Mantel-Haenszel (CMH) weights method adjusted for actual stratum (dialysis status and prior antibacterial treatment use)|||4.8|-4.6|
70899758|NCT02612064|141288437|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.18||||0.1575|TWO_SIDED|95.0|-0.442|0.072|||ANCOVA|Change from baseline in Schiff Sensitivity Score as response, treatment as a factor and baseline Schiff sensitivity as a covariate.|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|All statistical analyses were conducted under the null hypothesis (H0) of no difference between treatments versus the alternate hypothesis (H1) of a difference between treatments.||0.072|-0.442|0.1575
70899759|NCT00279201|141288467|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANCOVA|P-value from ANCOVA, baseline value as covariate. Response = Treatment + Baseline + Country + thiazolidinedione (TZD) use + Sulfonylurea (sulfo) use.||||||0.005
70899760|NCT00279201|141288468|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Log Rank|Stratified by country, thiazolidinedione (TZD) use, sulfo use.||||||0.040
70899761|NCT00279201|141288469|SUPERIORITY_OR_OTHER|||||||0.271||95.0|||||ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.271
70899762|NCT00279201|141288469|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.990
70899763|NCT00279201|141288470|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo use.||||||0.005
70899764|NCT00279201|141288471|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for \<=7.0%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.002
70899765|NCT00279201|141288471|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for \<7.0%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||<0.001
70899766|NCT00279201|141288471|SUPERIORITY_OR_OTHER|||||||0.174||95.0||||P-value is for \<=6.5%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.174
70899767|NCT00279201|141288472|SUPERIORITY_OR_OTHER|||||||0.416||95.0||||P-value for baseline.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.416
70899768|NCT00279201|141288472|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
70899769|NCT00279201|141288472|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.003
70899770|NCT00279201|141288472|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.005
70899771|NCT00279201|141288473|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||P-value is for Baseline mean fasting blood glucose.|ANOVA|ANOVA with treatment, country, TZD use and sulfo use in model.||||||0.179
70899772|NCT00279201|141288473|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for mean fasting blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
70899773|NCT00279201|141288473|SUPERIORITY_OR_OTHER|||||||0.7||95.0||||P-value is for Baseline AM 2-hour postprandial BG.|ANOVA|ANOVA with treatment, country, TZD use and sulfo use in model.||||||0.700
70899774|NCT00279201|141288473|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value for AM 2-hour postprandial blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.016
70899775|NCT00279201|141288473|SUPERIORITY_OR_OTHER|||||||0.971||95.0||||P-value is for Baseline midday premeal BG.|ANOVA|ANOVA with treatment, country, TZD use and sulfo use in model.||||||0.971
70899776|NCT00279201|141288473|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Midday premeal blood glucose (BG).|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
70899777|NCT00279201|141288473|SUPERIORITY_OR_OTHER|||||||0.759||95.0||||P-value is for Baseline midday 2-hour postprandial BG|ANOVA|ANOVA with treatment, country, TZD use and sulfo use in model.||||||0.759
70899778|NCT00279201|141288473|SUPERIORITY_OR_OTHER|||||||0.514||95.0||||P-value Midday 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.514
70899779|NCT00279201|141288473|SUPERIORITY_OR_OTHER|||||||0.321||95.0||||P-value is for Baseline evening pre-meal BG.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.321
70899780|NCT00279201|141288473|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-value for Evening pre-meal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.161
70899781|NCT00279201|141288473|SUPERIORITY_OR_OTHER|||||||0.297||95.0||||P-value is for Baseline evening 2hour postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.297
70899782|NCT00279201|141288473|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value Evening 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
70899783|NCT00279201|141288473|SUPERIORITY_OR_OTHER|||||||0.199||95.0||||P-value is for Baseline 3 AM blood glucose.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.199
70899784|NCT00279201|141288473|SUPERIORITY_OR_OTHER|||||||0.693||95.0||||P-value is for 3 AM blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.693
70899785|NCT00279201|141288473|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value is for Baseline AM 2-hour BG excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.021
70899786|NCT00279201|141288473|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for AM 2-hour blood glucose excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
70899787|NCT00279201|141288473|SUPERIORITY_OR_OTHER|||||||0.567||95.0||||P-value is for Baseline midday 2-hour BG excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.567
70899788|NCT00279201|141288473|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value is for Midday 2-hour blood glucose excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.005
70899789|NCT00279201|141288473|SUPERIORITY_OR_OTHER|||||||0.994||95.0||||P-value is for Baseline PM 2-hour BG excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.994
70899790|NCT00279201|141288473|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for PM 2-hour blood glucose excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
70899791|NCT00279201|141288473|SUPERIORITY_OR_OTHER|||||||0.436||95.0||||P-value is for Baseline mean all meal time excursions.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.436
70899792|NCT00279201|141288473|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Mean of all meal time excursions.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
70899793|NCT00279201|141288473|SUPERIORITY_OR_OTHER|||||||0.628||95.0||||P-value is for Baseline mean all 2hour PP BG.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.628
70899794|NCT00279201|141288473|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Mean of all 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
70899795|NCT00279201|141288473|SUPERIORITY_OR_OTHER|||||||0.677||95.0||||P-value is for Baseline AM/PM 2-hour postprandial BG.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.677
70899796|NCT00279201|141288473|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for AM/PM 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
70899797|NCT00279201|141288473|SUPERIORITY_OR_OTHER|||||||0.364||95.0||||P-value is for Baseline mean all premeal BG.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.364
70899798|NCT00279201|141288473|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||P-value is for Mean of all premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.055
70899799|NCT00279201|141288473|SUPERIORITY_OR_OTHER|||||||0.165||95.0||||P-value is for Baseline AM/PM 2-hour BG excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.165
70899800|NCT00279201|141288473|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for AM/PM 2-hour blood glucose excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
70899801|NCT00279201|141288473|SUPERIORITY_OR_OTHER|||||||0.464||95.0||||P-value is for Baseline mean of all BG values.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.464
70899802|NCT00279201|141288473|SUPERIORITY_OR_OTHER|||||||0.305||95.0||||P-value is for Mean of all blood glucose values.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.305
70899803|NCT00279201|141288474|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANCOVA|ANCOVA model with treatment, baseline, country, TZD use, and sulfo use.||||||0.003
70899804|NCT00279201|141288475|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change from baseline at Week 6.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
70899805|NCT00279201|141288475|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change from baseline at Week 12.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
70899806|NCT00279201|141288475|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change from baseline at Week 18|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
70899807|NCT00279201|141288475|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change from baseline at Week 24.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
70899808|NCT00279201|141288475|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change from baseline at endpoint.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
70899809|NCT00279201|141288476|SUPERIORITY_OR_OTHER|||||||0.497||95.0||||P-value for Actual weight at baseline.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.497
70899810|NCT00279201|141288476|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Actual weight at Week 6.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
70899811|NCT00279201|141288476|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Actual weight at Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo use.||||||<0.001
70899812|NCT00279201|141288476|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Actual weight at Week 18.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo use.||||||<0.001
70899813|NCT00279201|141288476|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Actual weight at Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo use.||||||<0.001
70899814|NCT00279201|141288476|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value is for Actual weight at Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo use.||||||<0.0001
70899815|NCT00279201|141288477|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value is for Hypoglycemic episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.016
70899816|NCT00279201|141288477|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||P-value is for Overall hypoglycemic episodes.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.037
70899817|NCT00279201|141288477|SUPERIORITY_OR_OTHER|||||||0.834||95.0||||P-value is for Nocturnal hypoglycemic episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.834
70899818|NCT00279201|141288477|SUPERIORITY_OR_OTHER|||||||0.585||95.0||||P-value is for Nocturnal hypoglycemic episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.585
70899819|NCT00279201|141288477|SUPERIORITY_OR_OTHER|||||||0.241||95.0||||P-value is for Severe hypoglycemic episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.241
70899820|NCT00279201|141288477|SUPERIORITY_OR_OTHER|||||||0.08||95.0||||P-value is for Severe hypoglycemic episodes overall. Initiation phase and maintenance phase are included.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.080
70899821|NCT00279201|141288478|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value is for Nocturnal episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.009
70899822|NCT00279201|141288478|SUPERIORITY_OR_OTHER|||||||0.42||95.0||||P-value is for Nocturnal episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.420
70899823|NCT00279201|141288478|SUPERIORITY_OR_OTHER|||||||0.165||95.0||||P-value is for Severe episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.165
70899824|NCT00279201|141288478|SUPERIORITY_OR_OTHER|||||||0.167||95.0||||P-value is for Severe episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.167
70899825|NCT00279201|141288478|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value is for Hypoglycemia episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.006
70899826|NCT00279201|141288478|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Hypoglycemia episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||<0.001
70899827|NCT00279201|141288479|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 1.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
70899828|NCT00279201|141288479|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 2.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
70899829|NCT00279201|141288479|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 3.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
70899830|NCT00279201|141288479|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 4.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
70899831|NCT00279201|141288479|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 5.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
70899832|NCT00279201|141288479|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 6.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
70899833|NCT00279201|141288479|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 8.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
70899834|NCT00279201|141288479|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 10.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
70899835|NCT00279201|141288479|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 12.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
70899836|NCT00279201|141288479|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value is for Week 18.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||0.001
70899837|NCT00279201|141288479|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 24.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
70899838|NCT00279201|141288479|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
70899839|NCT00279201|141288480|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
70899840|NCT00279201|141288481|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country, TZD use, and Sulfo use.||||||<0.001
70899841|NCT00279201|141288482|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
70899842|NCT00279201|141288483|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|ANOVA with met goal/did not meet goal, country, TZD use and Sulfo use in model.||||||<0.001
70899843|NCT00279201|141288484|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country, TZD use, and sulfo use.||||||<0.001
70899844|NCT00279201|141288485|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
70899845|NCT00279201|141288486|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Pre Meals Blood Glucose.|ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
70899846|NCT00279201|141288486|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Post Meals Blood Glucose.|ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
70899847|NCT00279201|141288486|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Average of All Blood Glucose.|ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
70899848|NCT00279201|141288486|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Fasting Blood Glucose.|ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
70899849|NCT00279201|141288487|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Sulfonylurea/Metformin.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||<0.001
70899850|NCT00279201|141288487|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for TZD/Metformin.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||<0.001
70899851|NCT00279201|141288487|SUPERIORITY_OR_OTHER|||||||0.969||95.0||||P-value is for Sulfonylurea/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.969
70899852|NCT00279201|141288487|SUPERIORITY_OR_OTHER|||||||0.225||95.0||||P-value is for Patients with 3 drugs (Sulfonylurea/TZD/Metformin).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.225
70899853|NCT00279201|141288488|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||P-value is for Week 0.|ANOVA|ANCOVA used with treatment, country, TZD use, and sulfo use in the model.||||||0.204
70899854|NCT00279201|141288488|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value is for Week 12.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.004
70899855|NCT00279201|141288488|SUPERIORITY_OR_OTHER|||||||0.657||95.0||||P-value is for Week 24.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.657
70899856|NCT00279201|141288488|SUPERIORITY_OR_OTHER|||||||0.595||95.0||||P-value is for Week 36.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.595
70899857|NCT00279201|141288488|SUPERIORITY_OR_OTHER|||||||0.142||95.0||||P-value for Week 48.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.142
70899858|NCT00279201|141288488|SUPERIORITY_OR_OTHER|||||||0.551||95.0||||P-value for Week 60.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.551
70899859|NCT00279201|141288488|SUPERIORITY_OR_OTHER|||||||0.779||95.0||||P-value is for Week 72.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.779
70899860|NCT00279201|141288488|SUPERIORITY_OR_OTHER|||||||0.175||95.0||||P-value is for Week 84.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.175
70899861|NCT00279201|141288488|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||P-value for Week 96.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.018
70899862|NCT00279201|141288488|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-value is for Week 108.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.047
70899863|NCT00279201|141288488|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||P-value is for Week 120.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.027
70899864|NCT00279201|141288488|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value is for Endpoint.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.017
70899865|NCT00279201|141288489|SUPERIORITY_OR_OTHER|||||||0.218||95.0||||P-value for Baseline mean fasting blood glucose.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.218
70899866|NCT00279201|141288489|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint mean fasting blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||<0.001
70899867|NCT00279201|141288489|SUPERIORITY_OR_OTHER|||||||0.897||95.0||||P-value is for Baseline AM 2-hour (hr) postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.897
70899868|NCT00279201|141288489|SUPERIORITY_OR_OTHER|||||||0.138||95.0||||P-value is for Endpoint AM 2-hour postprandial.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.138
70899869|NCT00279201|141288489|SUPERIORITY_OR_OTHER|||||||0.867||95.0||||P-value is for Baseline midday premeal blood glucose.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.867
70899870|NCT00279201|141288489|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||P-value is for Endpoint midday premeal blood.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.031
70899871|NCT00279201|141288489|SUPERIORITY_OR_OTHER|||||||0.792||95.0||||P-value is for Baseline midday 2hr postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.792
70899872|NCT00279201|141288489|SUPERIORITY_OR_OTHER|||||||0.51||95.0||||P-value is for Endpoint midday 2hr postprandial.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.510
70899873|NCT00279201|141288489|SUPERIORITY_OR_OTHER|||||||0.535||95.0||||P-value is for Baseline PM pre-meal blood glucose.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.535
70899874|NCT00279201|141288489|SUPERIORITY_OR_OTHER|||||||0.517||95.0||||P-value is for Endpoint PM pre-meal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.517
70899875|NCT00279201|141288489|SUPERIORITY_OR_OTHER|||||||0.869||95.0||||P-value is for Baseline PM 2hr postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.869
70899876|NCT00279201|141288489|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint PM 2hr postprandial.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||<0.001
70899877|NCT00279201|141288489|SUPERIORITY_OR_OTHER|||||||0.164||95.0||||P-value is for Baseline 3AM blood glucose.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.164
70899878|NCT00279201|141288489|SUPERIORITY_OR_OTHER|||||||0.234||95.0||||P-value is for Endpoint 3AM blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.234
70899879|NCT00279201|141288489|SUPERIORITY_OR_OTHER|||||||0.175||95.0||||P-value is for Baseline AM 2hr excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.175
70899880|NCT00279201|141288489|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint AM 2hr excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||<0.001
70899881|NCT00279201|141288489|SUPERIORITY_OR_OTHER|||||||0.589||95.0||||P-value is for Baseline midday 2hr excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.589
70899882|NCT00279201|141288489|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-value is for Endpoint midday 2hr excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.161
70899883|NCT00279201|141288489|SUPERIORITY_OR_OTHER|||||||0.674||95.0||||P-value is for Baseline PM 2hr excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.674
70899884|NCT00279201|141288489|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint PM 2hr excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||<0.001
70899885|NCT00279201|141288489|SUPERIORITY_OR_OTHER|||||||0.201||95.0||||P-value is for Baseline mean all meal time excursions.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.201
70899886|NCT00279201|141288489|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint mean all meal time excursions.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||<0.001
70899887|NCT00279201|141288489|SUPERIORITY_OR_OTHER|||||||0.956||95.0||||P-value is for Baseline mean of all 2hr postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.956
70899888|NCT00279201|141288489|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-value is for Endpoint mean of all 2hr postprandial.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.019
70899889|NCT00279201|141288489|SUPERIORITY_OR_OTHER|||||||0.445||95.0||||P-value is for Baseline mean all premeal.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.445
70899890|NCT00279201|141288489|SUPERIORITY_OR_OTHER|||||||0.371||95.0||||P-value is for Endpoint mean all premeal.|ANOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.371
70899891|NCT00279201|141288489|SUPERIORITY_OR_OTHER|||||||0.848||95.0||||P-value is for Baseline combined AM/PM 2hr postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.848
70899892|NCT00279201|141288489|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for Endpoint combined AM/PM 2hr postprandial.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.002
70899893|NCT00279201|141288489|SUPERIORITY_OR_OTHER|||||||0.281||95.0||||P-value is for Baseline AM/PM 2hr postprandial excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.281
70899894|NCT00279201|141288489|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint AM/PM 2hr postprandial excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||<0.001
70899895|NCT00279201|141288489|SUPERIORITY_OR_OTHER|||||||0.588||95.0||||P-value is for Baseline mean all blood glucose values.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.588
70899896|NCT00279201|141288489|SUPERIORITY_OR_OTHER|||||||0.217||95.0||||P-value is for Endpoint mean all blood glucose values.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.217
70899897|NCT00279201|141288490|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||ANCOVA|ANCOVA used with treatment, Baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.300
70899898|NCT00279201|141288491|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||P-value for \<=7.0%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.134
70899899|NCT00279201|141288491|SUPERIORITY_OR_OTHER|||||||0.089||95.0||||P-value is for \<7.0%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.089
70899900|NCT00279201|141288491|SUPERIORITY_OR_OTHER|||||||0.235||95.0||||P-value is for \<=6.5%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.235
70899901|NCT00279201|141288492|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 24.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
70899902|NCT00279201|141288492|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 36.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
70899903|NCT00279201|141288492|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 48.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
70899904|NCT00279201|141288492|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 60.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
70899905|NCT00279201|141288492|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 72.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
70899906|NCT00279201|141288492|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 84.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
70899907|NCT00279201|141288492|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 96.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
70899908|NCT00279201|141288492|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 108|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
70899909|NCT00279201|141288492|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for Change from baseline at Week 120.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||0.002
70899910|NCT00279201|141288492|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Endpoint.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
70899911|NCT00279201|141288493|SUPERIORITY_OR_OTHER|||||||0.128||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.128
70899912|NCT00279201|141288493|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
70899913|NCT00279201|141288493|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 36.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
70899914|NCT00279201|141288493|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 48.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
70899915|NCT00279201|141288493|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 60.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
70899916|NCT00279201|141288493|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 72.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
70899917|NCT00279201|141288493|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 84.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
70899918|NCT00279201|141288493|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 96.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
70899919|NCT00279201|141288493|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 108.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
70899920|NCT00279201|141288493|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for Week 120.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||0.002
70899921|NCT00279201|141288493|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
70899922|NCT00279201|141288494|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 24.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
70899923|NCT00279201|141288494|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 36.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
70899924|NCT00279201|141288494|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 48.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
70899925|NCT00279201|141288494|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 60.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
70899926|NCT00279201|141288494|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 72.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
70899927|NCT00279201|141288494|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 84.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
70899928|NCT00279201|141288494|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 96.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
70899929|NCT00279201|141288494|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 108.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
70899930|NCT00279201|141288494|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 120.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
70899931|NCT00279201|141288494|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
70899932|NCT00279201|141288495|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||P-value is for Overall hypoglycemic episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.370
70899933|NCT00279201|141288495|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-Value for Overall hypoglycemia episodes.|Cochran-Mantel-Haenszel|Controlling for country, TZD use, and sulfo use.||||||0.006
70899934|NCT00279201|141288495|SUPERIORITY_OR_OTHER|||||||0.397||95.0||||P-value is for Nocturnal episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.397
70899935|NCT00279201|141288495|SUPERIORITY_OR_OTHER|||||||0.253||95.0||||P-value is for Nocturnal episodes overall.|Cochran-Mantel-Haenszel|Controlling for country, TZD use, and sulfo use.||||||0.253
70899936|NCT00279201|141288495|SUPERIORITY_OR_OTHER|||||||0.893||95.0||||P-value is for Severe episodes endpoint.|Cochran-Mantel-Haenszel|Controlling for country, TZD use, and sulfo use.||||||0.893
70899937|NCT00279201|141288495|SUPERIORITY_OR_OTHER|||||||0.391||95.0||||P-value is for Severe episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.391
70899938|NCT00279201|141288496|SUPERIORITY_OR_OTHER|||||||0.497||95.0||||P-value for Hypoglycemia episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.497
70899939|NCT00279201|141288496|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||P-value is for Hypoglycemia episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.071
70899940|NCT00279201|141288496|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||P-value is for Nocturnal episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.065
70899941|NCT00279201|141288496|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value is for Nocturnal episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.021
70899942|NCT00279201|141288496|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||P-value is for Severe episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.200
70899943|NCT00279201|141288496|SUPERIORITY_OR_OTHER|||||||0.208||95.0||||P-value is for Severe episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.208
70899944|NCT00279201|141288497|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value is for Change.|ANCOVA|ANCOVA model with treatment, baseline, country, TZD use and sulfo use.||||||0.004
70899945|NCT00279201|141288498|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||P-value is for Baseline at Week 0.|ANOVA|ANOVA used with treatment, country, TZD use and Sulfo use in the model.||||||0.204
70899946|NCT00279201|141288498|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-Value is for Change from baseline to endpoint.|ANCOVA|ANCOVA used with treatment, Baseline HbA1c, country, TZD use and sulfo use in the model.||||||0.017
70899947|NCT00279201|141288498|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||P-value is for Change Week 24 to Week 120 endpoint.|ANCOVA|ANCOVA used with treatment, Baseline HbA1c, country, TZD use and sulfo use in the model.||||||0.020
70899948|NCT00279201|141288499|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.036
70899949|NCT00279201|141288500|SUPERIORITY_OR_OTHER|||||||0.708||95.0|||||ANOVA|From ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.708
70899950|NCT00279201|141288501|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country, TZD use, and Sulfo use.||||||0.028
70899951|NCT00279201|141288502|SUPERIORITY_OR_OTHER|||||||0.738||95.0|||||Cochran-Mantel-Haenszel|Stratified by country, TZD use, and sulfo use.||||||0.738
70899952|NCT00279201|141288503|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||<0.001
70899953|NCT00279201|141288504|SUPERIORITY_OR_OTHER|||||||0.043||95.0|||||ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.043
70899954|NCT00279201|141288505|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country, TZD use, and sulfo use.||||||<0.001
70899955|NCT00279201|141288506|SUPERIORITY_OR_OTHER|||||||0.032||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country, TZD use, and sulfo use.||||||0.032
70899956|NCT00279201|141288507|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||P-value is for Sulfonylurea/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.037
70899957|NCT00279201|141288507|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||P-value is for Sulfonylurea/metformin.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.025
70899958|NCT00279201|141288507|SUPERIORITY_OR_OTHER|||||||0.132||95.0||||P-value is for Metformin/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.132
70899959|NCT00279201|141288507|SUPERIORITY_OR_OTHER|||||||0.849||95.0||||P-value is for Sulfonylurea/metformin/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.849
70899960|NCT00279201|141288508|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value is for Sulfonylurea/TZD|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.006
70899961|NCT00279201|141288508|SUPERIORITY_OR_OTHER|||||||0.048||95.0||||P-value is for Sulfonylurea/metformin.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.048
70899962|NCT00279201|141288508|SUPERIORITY_OR_OTHER|||||||0.258||95.0||||P-value is for Metformin/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.258
70899963|NCT00279201|141288508|SUPERIORITY_OR_OTHER|||||||0.848||95.0||||P-value is for Sulfonylurea/metformin/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.848
70899964|NCT00279201|141288509|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.004
70899965|NCT00279201|141288510|SUPERIORITY_OR_OTHER|||||||0.553||95.0|||||ANOVA|From ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.553
70899966|NCT00279201|141288511|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value is for Mean of all post meals blood glucose.|ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.010
70899967|NCT00279201|141288511|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||P-value is for Average of all blood glucose.|ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.035
70899968|NCT00279201|141288512|SUPERIORITY_OR_OTHER|||||||0.516||95.0||||P-value is for Mean of post-meals blood glucose.|ANOVA|From ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.516
70899969|NCT00279201|141288512|SUPERIORITY_OR_OTHER|||||||0.425||95.0||||P-value is for Average of all blood glucose.|ANOVA|From ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.425
70899970|NCT00279201|141288513|SUPERIORITY_OR_OTHER|||||||0.77||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.770
70899971|NCT00279201|141288513|SUPERIORITY_OR_OTHER|||||||0.99||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.990
70899972|NCT00279201|141288513|SUPERIORITY_OR_OTHER|||||||0.552||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.552
70899973|NCT00279201|141288513|SUPERIORITY_OR_OTHER|||||||0.271||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.271
70899974|NCT00279201|141288514|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||P-value is for \<=7.0%.|Fisher Exact|||||||0.027
70899975|NCT00279201|141288514|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value is for \<7.0%.|Fisher Exact|||||||0.021
70899976|NCT00279201|141288514|SUPERIORITY_OR_OTHER|||||||0.799||95.0||||P-value is for \<=6.5%.|Fisher Exact|||||||0.799
70899977|NCT00279201|141288514|SUPERIORITY_OR_OTHER|||||||0.676||95.0||||P-value is for \<=7.0%.|Fisher Exact|||||||0.676
70899978|NCT00279201|141288514|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for \<7.0%.|Fisher Exact|||||||1.000
70899979|NCT00279201|141288514|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for \<=6.5%.|Fisher Exact|||||||1.000
70899980|NCT00279201|141288515|SUPERIORITY_OR_OTHER|||||||0.241||95.0||||P-value is for Mean fast blood glucose (BG).|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.241
70899981|NCT00279201|141288515|SUPERIORITY_OR_OTHER|||||||0.305||95.0||||P-value is for AM 2-hour postprandial (PP) BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.305
70899982|NCT00279201|141288515|SUPERIORITY_OR_OTHER|||||||0.842||95.0||||P-value is for Midday premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.842
70899983|NCT00279201|141288515|SUPERIORITY_OR_OTHER|||||||0.917||95.0||||P-value is for Midday 2-hour (hr) PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.917
70899984|NCT00279201|141288515|SUPERIORITY_OR_OTHER|||||||0.648||95.0||||P-value is for PM premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.648
70899985|NCT00279201|141288515|SUPERIORITY_OR_OTHER|||||||0.613||95.0||||P-value is for PM 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.613
70899986|NCT00279201|141288515|SUPERIORITY_OR_OTHER|||||||0.813||95.0||||P-value is for 3 AM blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.813
70899987|NCT00279201|141288515|SUPERIORITY_OR_OTHER|||||||0.953||95.0||||P-value is for AM 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.953
70899988|NCT00279201|141288515|SUPERIORITY_OR_OTHER|||||||0.933||95.0||||P-value is for Midday 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.933
70899989|NCT00279201|141288515|SUPERIORITY_OR_OTHER|||||||0.348||95.0||||P-value is for PM 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.348
70899990|NCT00279201|141288515|SUPERIORITY_OR_OTHER|||||||0.625||95.0||||P-value is for Mean all mealtime excursions.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.625
70899991|NCT00279201|141288515|SUPERIORITY_OR_OTHER|||||||0.573||95.0||||P-value is for Mean all 2-hour PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.573
70899992|NCT00279201|141288515|SUPERIORITY_OR_OTHER|||||||0.711||95.0||||P-value is for Mean all premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.711
70899993|NCT00279201|141288515|SUPERIORITY_OR_OTHER|||||||0.372||95.0||||P-value is for Mean combined AM/PM 2hr PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.372
70899994|NCT00279201|141288515|SUPERIORITY_OR_OTHER|||||||0.516||95.0||||P-value is for Mean AM/PM 2hr BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.516
70899995|NCT00279201|141288515|SUPERIORITY_OR_OTHER|||||||0.639||95.0||||P-value is for Mean all BG values.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.639
70899996|NCT00279201|141288515|SUPERIORITY_OR_OTHER|||||||0.131||95.0||||P-value is for Mean fast blood glucose (BG).|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.131
70899997|NCT00279201|141288515|SUPERIORITY_OR_OTHER|||||||0.53||95.0||||P-value is for AM 2-hour postprandial (PP) BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.530
70899998|NCT00279201|141288515|SUPERIORITY_OR_OTHER|||||||0.578||95.0||||P-value is for Midday premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.578
70899999|NCT00279201|141288515|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value is for Midday 2-hour (hr) PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.004
70900000|NCT00279201|141288515|SUPERIORITY_OR_OTHER|||||||0.951||95.0||||P-value is for PM premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.951
70900001|NCT00279201|141288515|SUPERIORITY_OR_OTHER|||||||0.58||95.0||||P-value is for PM 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.580
70900002|NCT00279201|141288515|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||P-value is for 3 AM blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.071
70900003|NCT00279201|141288515|SUPERIORITY_OR_OTHER|||||||0.081||95.0||||P-value is for AM 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.081
70900004|NCT00279201|141288515|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Midday 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||<0.001
70900005|NCT00279201|141288515|SUPERIORITY_OR_OTHER|||||||0.542||95.0||||P-value is for PM 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.542
70900006|NCT00279201|141288515|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value is for Mean all mealtime excursions.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.003
70900007|NCT00279201|141288515|SUPERIORITY_OR_OTHER|||||||0.105||95.0||||P-value is for Mean all 2-hour PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.105
70900008|NCT00279201|141288515|SUPERIORITY_OR_OTHER|||||||0.487||95.0||||P-value is for Mean all premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.487
70900009|NCT00279201|141288515|SUPERIORITY_OR_OTHER|||||||0.491||95.0||||P-value is for Mean combined AM/PM 2hr PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.491
70900010|NCT00279201|141288515|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||P-value is for Mean AM/PM 2hr BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.127
70900011|NCT00279201|141288515|SUPERIORITY_OR_OTHER|||||||0.861||95.0||||P-value is for Mean all BG values.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.861
70900012|NCT00279201|141288516|SUPERIORITY_OR_OTHER|||||||0.745||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.745
70900013|NCT00279201|141288516|SUPERIORITY_OR_OTHER|||||||0.467||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.467
70900014|NCT00279201|141288516|SUPERIORITY_OR_OTHER|||||||0.575||95.0||||P-value is for Week 6.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.575
70900015|NCT00279201|141288516|SUPERIORITY_OR_OTHER|||||||0.726||95.0||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.726
70900016|NCT00279201|141288516|SUPERIORITY_OR_OTHER|||||||0.978||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.978
70900017|NCT00279201|141288516|SUPERIORITY_OR_OTHER|||||||0.345||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.345
70900018|NCT00279201|141288516|SUPERIORITY_OR_OTHER|||||||0.166||95.0||||P-value is for Week 6.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.166
70900019|NCT00279201|141288516|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.064
70900020|NCT00279201|141288516|SUPERIORITY_OR_OTHER|||||||0.199||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.199
70900021|NCT00279201|141288516|SUPERIORITY_OR_OTHER|||||||0.098||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.098
70900022|NCT00279201|141288517|SUPERIORITY_OR_OTHER|||||||0.467||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, and TZD use in model.||||||0.467
70900023|NCT00279201|141288517|SUPERIORITY_OR_OTHER|||||||0.575||95.0||||P-value is for Week 6.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.575
70900024|NCT00279201|141288517|SUPERIORITY_OR_OTHER|||||||0.726||95.0||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.726
70900025|NCT00279201|141288517|SUPERIORITY_OR_OTHER|||||||0.978||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.978
70900026|NCT00279201|141288517|SUPERIORITY_OR_OTHER|||||||0.345||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.345
70900027|NCT00279201|141288517|SUPERIORITY_OR_OTHER|||||||0.745||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, and TZD use in model.||||||0.745
70900028|NCT00279201|141288517|SUPERIORITY_OR_OTHER|||||||0.166||95.0||||P-value is for Week 6.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.166
70900029|NCT00279201|141288517|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.064
70900030|NCT00279201|141288517|SUPERIORITY_OR_OTHER|||||||0.199||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.199
70900031|NCT00279201|141288517|SUPERIORITY_OR_OTHER|||||||0.098||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.098
70900032|NCT00279201|141288518|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||P-value is for Week 1.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.837
70900033|NCT00279201|141288518|SUPERIORITY_OR_OTHER|||||||0.205||95.0||||P-value is for Week 2.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.205
70900034|NCT00279201|141288518|SUPERIORITY_OR_OTHER|||||||0.704||95.0||||P-value is for Week 3.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.704
70900035|NCT00279201|141288518|SUPERIORITY_OR_OTHER|||||||0.61||95.0||||P-value is for Week 4.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.610
70900036|NCT00279201|141288518|SUPERIORITY_OR_OTHER|||||||0.352||95.0||||P-value is for Week 5.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.352
70900037|NCT00279201|141288518|SUPERIORITY_OR_OTHER|||||||0.636||95.0||||P-value is for Week 6.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.636
70900038|NCT00279201|141288518|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||P-value is for Week 8.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.880
70900039|NCT00279201|141288518|SUPERIORITY_OR_OTHER|||||||0.904||95.0||||P-value is for Week 10.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.904
70900040|NCT00279201|141288518|SUPERIORITY_OR_OTHER|||||||0.859||95.0||||P-value is for Week 12.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.859
70900041|NCT00279201|141288518|SUPERIORITY_OR_OTHER|||||||0.654||95.0||||P-value is for Week 24.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.654
70900042|NCT00279201|141288518|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||P-value is for Endpoint.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.566
70900043|NCT00279201|141288518|SUPERIORITY_OR_OTHER|||||||0.926||95.0||||P-value is for Week 1.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.926
70900044|NCT00279201|141288518|SUPERIORITY_OR_OTHER|||||||0.902||95.0||||P-value is for Week 2.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.902
70900045|NCT00279201|141288518|SUPERIORITY_OR_OTHER|||||||0.766||95.0||||P-value is for Week 3.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.766
70900046|NCT00279201|141288518|SUPERIORITY_OR_OTHER|||||||0.449||95.0||||P-value is for Week 4.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.449
70900047|NCT00279201|141288518|SUPERIORITY_OR_OTHER|||||||0.797||95.0||||P-value is for Week 5.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.797
70900048|NCT00279201|141288518|SUPERIORITY_OR_OTHER|||||||0.438||95.0||||P-value is for Week 6.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.438
70900049|NCT00279201|141288518|SUPERIORITY_OR_OTHER|||||||0.602||95.0||||P-value is for Week 8.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.602
70900050|NCT00279201|141288518|SUPERIORITY_OR_OTHER|||||||0.493||95.0||||P-value is for Week 10.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.493
70900051|NCT00279201|141288518|SUPERIORITY_OR_OTHER|||||||0.335||95.0||||P-value is for Week 12.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.335
70900052|NCT00279201|141288518|SUPERIORITY_OR_OTHER|||||||0.398||95.0||||P-value is for Week 24.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.398
70900053|NCT00279201|141288518|SUPERIORITY_OR_OTHER|||||||0.903||95.0||||P-value is for Endpoint.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.903
70900054|NCT00279201|141288519|SUPERIORITY_OR_OTHER|||||||0.953||95.0||||P-value is for Hypoglycemia episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.953
70900055|NCT00279201|141288519|SUPERIORITY_OR_OTHER|||||||0.953||95.0||||P-value is for Overall hypoglycemia episodes.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.953
70900056|NCT00279201|141288519|SUPERIORITY_OR_OTHER|||||||0.188||95.0||||P-value is for Severe episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.188
70900057|NCT00279201|141288519|SUPERIORITY_OR_OTHER|||||||0.226||95.0||||P-value is for Nocturnal episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.226
70900058|NCT00279201|141288519|SUPERIORITY_OR_OTHER|||||||0.855||95.0||||P-value is for Nocturnal episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.855
70900059|NCT00279201|141288519|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||P-value is for Hypoglycemia episodes at endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.250
70900060|NCT00279201|141288519|SUPERIORITY_OR_OTHER|||||||0.123||95.0||||P-value is for Overall hypoglycemia episodes.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.123
70900061|NCT00279201|141288519|SUPERIORITY_OR_OTHER|||||||0.166||95.0||||P-value is for Severe episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.166
70900062|NCT00279201|141288519|SUPERIORITY_OR_OTHER|||||||0.273||95.0||||P-value is for Nocturnal episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.273
70900063|NCT00279201|141288519|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||P-value is for Nocturnal episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.039
70900064|NCT00279201|141288520|SUPERIORITY_OR_OTHER|||||||0.623||95.0||||P-value is for Hypoglycemia episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.623
70900065|NCT00279201|141288520|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||P-value is for Hypoglycemic episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.949
70900066|NCT00279201|141288520|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||P-value is for Hypoglycemia episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.730
70900067|NCT00279201|141288520|SUPERIORITY_OR_OTHER|||||||0.445||95.0||||P-value is for Hypoglycemia episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.445
70900068|NCT00279201|141288520|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||P-value is for Nocturnal episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.949
70900069|NCT00279201|141288520|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||P-value is for Nocturnal episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.590
70900070|NCT00279201|141288520|SUPERIORITY_OR_OTHER|||||||0.657||95.0||||P-value is for Nocturnal episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.657
70900071|NCT00279201|141288520|SUPERIORITY_OR_OTHER|||||||0.108||95.0||||P-value is for Nocturnal episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.108
70900072|NCT00279201|141288520|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-value is for Severe episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.161
70900073|NCT00279201|141288520|SUPERIORITY_OR_OTHER|||||||0.178||95.0||||P-value is for Severe episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.178
70900074|NCT00279201|141288521|SUPERIORITY_OR_OTHER|||||||0.917||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.917
70900075|NCT00279201|141288521|SUPERIORITY_OR_OTHER|||||||0.754||95.0||||P-value for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.754
70900076|NCT00279201|141288521|SUPERIORITY_OR_OTHER|||||||0.42||95.0||||P-value is for Change.|ANCOVA|ANCOVA model with treatment, baseline, country, and TZD use.||||||0.420
70900077|NCT00279201|141288521|SUPERIORITY_OR_OTHER|||||||0.514||95.0||||P-value for Change.|ANCOVA|ANCOVA model with treatment, baseline, country, and TZD use.||||||0.514
70900078|NCT00279201|141288522|SUPERIORITY_OR_OTHER|||||||0.77||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.770
70900079|NCT00279201|141288522|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.566
70900080|NCT00279201|141288522|SUPERIORITY_OR_OTHER|||||||0.812||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.812
70900081|NCT00279201|141288522|SUPERIORITY_OR_OTHER|||||||0.99||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.990
70900082|NCT00279201|141288522|SUPERIORITY_OR_OTHER|||||||0.552||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.552
70900083|NCT00279201|141288522|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.179
70900084|NCT00279201|141288522|SUPERIORITY_OR_OTHER|||||||0.377||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.377
70900085|NCT00279201|141288522|SUPERIORITY_OR_OTHER|||||||0.271||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.271
70900086|NCT00316173|141288525|SUPERIORITY_OR_OTHER||Percentage of participants with CR+PR|30.9||||||95.0|18.7|43.1||||||||43.1|18.7|
70900087|NCT00511875|141288544|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||.70
70900088|NCT00511875|141288545|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||Foveal Sensitivity||||.33
70900089|NCT00511875|141288545|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||Mean field sensitivity||||.16
70900090|NCT00511875|141288546|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Foveal Sensitivity||||.02
70900091|NCT00511875|141288546|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||mean FDP sensitivity||||.3
70900092|NCT00511875|141288547|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|||||||.98
70900093|NCT00511875|141288548|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||.46
70900094|NCT00511875|141288549|SUPERIORITY|||||||0.81|||||||t-test, 2 sided|||||||.81
70900095|NCT00511875|141288550|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||||||.88
70900096|NCT00511875|141288551|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||||||.75
70900097|NCT00511875|141288552|SUPERIORITY|||||||0.62|||||||t-test, 2 sided|||||||.62
70900098|NCT02618616|141288553|OTHER||least square difference|8.7||||0.8495|ONE_SIDED|90.0|8.4|||The 1-sided p-value tests if the ZPL-389 Least square (LS) mean is \< the placebo LS mean.|ANCOVA|||ANCOVA of PASI at Week 12|||8.4|0.8495
70900099|NCT02618616|141288554|OTHER||Odds Ratio (OR)|0.562||||0.9058|TWO_SIDED|90.0|0.27|1.16|||Regression, Logistic|||Logistic Regression PASI-50||1.16|0.27|0.9058
70900100|NCT02618616|141288554|OTHER||Odds Ratio (OR)|0.946||||0.5422|TWO_SIDED|90.0|0.4|2.25|||Regression, Logistic|||Logistic Regression PASI-75||2.25|0.4|0.5422
70900101|NCT03938454|141288589|OTHER||Hodges-Lehmann|45.98||||0.0676|TWO_SIDED|95.0|23.5|65.36||P-value is from one-sided Wilcoxon Sign Rank Test with at least 25% percent reduction from Baseline (adjusted for 26 weeks) as outcome variable.|Wilcoxon Sign Rank Test|||||65.36|23.50|0.0676
70900102|NCT03938454|141288595|OTHER||Hodges-Lehmann|50.2||||0.0259|TWO_SIDED|95.0|27.94|67.36||P-value is from one-sided Wilcoxon Sign Rank Test with at least 25% reduction from Baseline (adjusted for 26 weeks) as outcome variable.|Wilcoxon Sign Rank Test|||||67.36|27.94|0.0259
70900103|NCT01142388|141288596|SUPERIORITY_OR_OTHER_LEGACY|||||||0.85|TWO_SIDED||||||Log Rank|one-sided stratified log rank test, stratifying on: 1) gastroesophageal junction vs. esophagus, 2) squamous cell carcinoma vs. adenocarcinoma.||||||0.85
70900104|NCT01142388|141288597|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|TWO_SIDED||||||Log Rank|one-sided stratified log rank test, stratifying on 1) gastroesophageal junction vs. esophagus, 2) squamous cell carcinoma vs. adenocarcinoma.||||||0.50
70900105|NCT02597907|141288605|OTHER||||||<|0.05|||||||Fisher Exact|||||||<0.05
70900106|NCT00335452|141288606|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|6.1||||0.3037|TWO_SIDED|95.0|-5.8|16.6||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by ASA dose level (low or high) and qualifying condition (UA/NSTEMI or STEMI) log-rank test.|The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using stratified Cox proportional hazards model controlling for ASA dose level and qualifying condition.|||16.6|-5.8|0.3037
70900107|NCT00335452|141288607|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||The a priori threshold for statistical significance is ≤0.05.|Regression, Logistic|logistic regression model including terms for ASA dose level (low or high) and qualifying condition (UA/NSTEMI or STEMI).||||||0.012
70900108|NCT00335452|141288608|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|3.1||||0.6047|TWO_SIDED|95.0|-9.2|14.0||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by clopidogrel treatment regimen (300/75/75 mg or 600/150/75 mg) log-rank test.|The relative risk reduction (ASA high dose versus ASA low dose) is estimated using stratified Cox proportional hazards model controlling for Clopidogrel treatment regimen.|||14.0|-9.2|0.6047
70900109|NCT00335452|141288609|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|-6.5||||0.4579|TWO_SIDED|95.0|-26.0|9.9||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by qualifying condition (UA/NSTEMI or STEMI) log-rank test.|The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using a stratified Cox proportional hazards model controlling for qualifying condition.|||9.9|-26.0|0.4579
70900110|NCT00335452|141288609|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|17.6||||0.0262|TWO_SIDED|95.0|2.2|30.5||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by qualifying condition (UA/NSTEMI or STEMI) log-rank test.|The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using a stratified Cox proportional hazards model controlling for qualifying condition.|||30.5|2.2|0.0262
70900111|NCT00335452|141288609|SUPERIORITY_OR_OTHER|||||||0.0355||95.0||||The a priori threshold for statistical significance is ≤0.05.|Chi-squared|Interaction chi-squared test of the Cox proportional hazards model.||||||0.0355
70900112|NCT00335452|141288610|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|14.7||||0.0332|TWO_SIDED|95.0|1.2|26.3||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by ASA dose level (low or high) and qualifying condition (UA/NSTEMI or STEMI) Log-rank test. No adjustment was made.|The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using a stratified Cox proportional hazards model controlling for ASA dose level and qualifying condition.|||26.3|1.2|0.0332
70900113|NCT00335452|141288611|SUPERIORITY_OR_OTHER|||||||0.945||95.0||||The a priori threshold for statistical significance is ≤0.05.|Regression, Logistic|Logistic regression model including a term for Clopidogrel treatment regimen (300/75/75 mg or 600/150/75 mg).||||||0.945
70900114|NCT00335452|141288612|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|32.6||||0.0004|TWO_SIDED|95.0|16.2|45.8||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by ASA dose level (low or high) and qualifying condition (UA/NSTEMI or STEMI) log-rank test.|The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using a stratified Cox proportional hazards model controlling for ASA dose level and qualifying condition.|||45.8|16.2|0.0004
70900115|NCT01904864|141288613|SUPERIORITY||Mean Difference (Net)|1.0|||<|0.001|TWO_SIDED|95.0|0.4|1.6|||Regression, Linear||Change at 12 weeks compared|||1.6|0.4|<0.001
70900116|NCT02093663|141288650|OTHER||Odds Ratio (OR)|3.21||||0.039|TWO_SIDED|95.0|1.04|9.88|||Uncorrected Chi-squared Test|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (last observation carried forward \[LOCF\] and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||9.88|1.04|0.039
70900117|NCT02093663|141288651|OTHER||Odds Ratio (OR)|0.99||||0.981|TWO_SIDED|95.0|0.42|2.34||P-value were based on a Cochran-Mantel-Haenszel test stratified by prior response status.|Cochran-Mantel-Haenszel|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-value s were presented as descriptive statistics.||2.34|0.42|0.981
70900118|NCT02093663|141288652|OTHER||Difference in proportions|50.0||||0.4|TWO_SIDED|95.0|-19.3|100.0||P-value was calculated based on Fisher's exact test.|Fisher Exact|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||100.0|-19.3|0.400
70900119|NCT02093663|141288653|OTHER||Difference in proportions|50.0||||0.333|TWO_SIDED|95.0|-19.3|100.0||P-value was based on a Fisher's exact test.|Fisher Exact|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate.||100.0|-19.3|0.333
70900120|NCT02093663|141288654|OTHER||Difference in Least squares Mean|-5.4||||0.168|TWO_SIDED|95.0|-13.1|2.4||P-value is based on an analysis of covariance (ANCOVA) including treatment arm as a factor and baseline DUCS score as a covariate.|ANCOVA|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||2.4|-13.1|0.168
70900121|NCT02093663|141288655|OTHER||Difference in proportions|24.5||||0.131|TWO_SIDED|95.0|-1.6|50.6||P-value was based on a continuity-corrected chi-squared test. PUCAI Score was compared between treatment arms using a continuity corrected chi-squared test. Expected cell counts are very low (\< 5), then Fisher's Exact Test is alternative method.|Chi-squared, Corrected|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||50.6|-1.6|0.131
70900122|NCT02093663|141288656|OTHER||Difference in Proportions Percentage|-6.5||||0.539|TWO_SIDED|95.0|-25.3|12.3||P-value is based on a CMH test adjusted by prior response status.|Cochran-Mantel-Haenszel|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||12.3|-25.3|0.539
70900123|NCT02093663|141288657|OTHER||Difference in proportions|-16.2||||0.129|TWO_SIDED|95.0|-36.0|3.6||P-value was based on a Cochran-Mantel-Haenszel (CMH) test adjusted by prior response status.|Cochran-Mantel-Haenszel|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||3.6|-36.0|0.129
70900124|NCT02093663|141288658|OTHER||Difference in Least squares Mean|3.0||||0.182|TWO_SIDED|95.0|-1.4|7.4||P-value was based on an analysis of covariance (ANCOVA) including treatment arm and with prior response status.|ANCOVA|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||7.4|-1.4|0.182
70900125|NCT02093663|141288659|OTHER||Difference in proportions|-9.0||||0.194|TWO_SIDED|95.0|-29.1|11.0||P-value was based on a CMH test adjusted by prior response status. Participants with remission (PUCAI \<10) at double-blind maintenance phase at Week 26 was compared between treatment arms using a CMH test stratifying by Week 8 responder status.|Cochran-Mantel-Haenszel|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||11.0|-29.1|0.194
70900126|NCT03662074|141288660|OTHER||||||||||||||||||The pre-specified analysis plan as per the protocol is to proceed to the second stage of recruitment for additional participants if the response proportion exceeds the historical control of 10%.|||
70900127|NCT02277990|141288693|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.0406|TWO_SIDED|95.12|0.36|0.98||The 0.05 critical value for assessing the primary endpoint was adjusted to 0.0488, to account for a planned interim analysis.|Regression, Cox|The Cox regression was stratified according to device type (pacemaker or CRT-P vs. ICD or CRT-D).||||0.98|0.36|0.0406
70900128|NCT02277990|141288694|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.0248|TWO_SIDED|95.12|0.47|0.96|||Regression, Cox|||||0.96|0.47|0.0248
70900129|NCT02277990|141288695|NON_INFERIORITY|The non-inferiority test was performed on the as-treated cohort, per the statistical analysis plan. The non-inferiority margin for the hazard ratio was 1.33 (i.e., the hazard ratio for complications in the envelope group vs. the control group must be significantly lower than 1.33).|Hazard Ratio (HR)|0.93|||<|0.01|TWO_SIDED|95.12|0.77|1.12|||Regression, Cox|||||1.12|0.77|<0.01
70900130|NCT02277990|141288696|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0402|TWO_SIDED|95.12|0.4|0.98|||Regression, Cox|||||0.98|0.40|0.0402
70900131|NCT04711603|141288697|SUPERIORITY||Placebo difference|-0.97|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.52|-0.42|||MMRM|||||-0.42|-1.52|<0.001
70900132|NCT04252742|141288714|SUPERIORITY||LSM difference|-7.95|||<|0.001|TWO_SIDED|95.0|-11.45|-4.46||Nominal p-value is presented without multiplicity adjustment.|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates.|Erenumab 140 mg SC Q4W - Placebo|||-4.46|-11.45|< 0.001
70900133|NCT04252742|141288715|SUPERIORITY||LSM difference|-7.36|||<|0.001|TWO_SIDED|95.0|-10.8|-3.92||Nominal p-value is presented without multiplicity adjustment.|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates.|Erenumab 140 mg SC Q4W - Placebo|||-3.92|-10.80|< 0.001
70900134|NCT04252742|141288716|SUPERIORITY||LSM difference|-7.1|||<|0.001|TWO_SIDED|95.0|-10.34|-3.87||Nominal p-value is presented without multiplicity adjustment|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates|Erenumab 140 mg SC Q4W - Placebo|||-3.87|-10.34|< 0.001
70900135|NCT04252742|141288717|SUPERIORITY||LSM difference|-7.05|||<|0.001|TWO_SIDED|95.0|-10.76|-3.34||Nominal p-value is presented without multiplicity adjustment|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates|Erenumab 140 mg SC Q4W - Placebo|||-3.34|-10.76|< 0.001
70900136|NCT04252742|141288718|SUPERIORITY||LSM difference|-6.82|||<|0.001|TWO_SIDED|95.0|-10.37|-3.27||Nominal p-value is presented without multiplicity adjustment|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates|Erenumab 140 mg SC Q4W - Placebo|||-3.27|-10.37|< 0.001
70900137|NCT04252742|141288719|SUPERIORITY||LSM difference|-1.07||||0.013|TWO_SIDED|95.0|-1.92|-0.22||Nominal p-value is presented without multiplicity adjustment.|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates.|Erenumab 140 mg SC Q4W - Placebo|||-0.22|-1.92|0.013
70900138|NCT04252742|141288720|SUPERIORITY||LSM difference|-0.48||||0.011|TWO_SIDED|95.0|-0.85|-0.11||Nominal p-value is presented without multiplicity adjustment|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates|Erenumab 140 mg SC Q4W - Placebo|||-0.11|-0.85|0.011
70900139|NCT04270747|141288737|OTHER|A pre-specified similarity margin of (-3, 3) ETDRS letters was used to demonstrate clinical similarity for the mean change from Baseline in BCVA at Week 8.|Difference between means|0.1|||||TWO_SIDED|90.0|-1.1|1.3|||||Estimated using analysis of covariance (ANCOVA) model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 8.||1.3|-1.1|
70900140|NCT04270747|141288738|OTHER||Risk Difference (RD)|-2.1|||||TWO_SIDED|90.0|-5.2|2.2|||||Estimated using the stratified Newcombe confidence limits (with Mantel-Haenszel weights) adjusting for stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters).|Risk difference in percentage of participants who maintained vision at Week 52.||2.2|-5.2|
70900141|NCT04270747|141288738|OTHER||Risk Difference (RD)|-1.7|||||TWO_SIDED|90.0|-6.2|2.8|||||Estimated using the stratified Newcombe confidence limits (with Mantel-Haenszel weights) adjusting for stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters).|Risk difference in percentage of participants who maintained vision at Week 52.||2.8|-6.2|
70900142|NCT04270747|141288739|OTHER||Difference between means|-0.1|||||TWO_SIDED|90.0|-1.3|1.2|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 4.||1.2|-1.3|
70900143|NCT04270747|141288739|OTHER||Difference between means|-0.8|||||TWO_SIDED|90.0|-2.3|0.7|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 8.||0.7|-2.3|
70900144|NCT04270747|141288739|OTHER||Difference between means|-0.3|||||TWO_SIDED|90.0|-1.9|1.2|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 16.||1.2|-1.9|
70900145|NCT04270747|141288739|OTHER||Difference between means|0.4|||||TWO_SIDED|90.0|-1.3|2.1|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 24.||2.1|-1.3|
70900146|NCT04270747|141288739|OTHER||Difference between means|-1.3|||||TWO_SIDED|90.0|-3.1|0.5|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 32.||0.5|-3.1|
70900147|NCT04270747|141288739|OTHER||Difference between means|-0.5|||||TWO_SIDED|90.0|-2.3|1.4|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 40.||1.4|-2.3|
70900148|NCT04270747|141288739|OTHER||Difference between means|-1.2|||||TWO_SIDED|90.0|-3.2|0.8|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 48.||0.8|-3.2|
70900149|NCT04270747|141288739|OTHER||Difference between means|-1.5|||||TWO_SIDED|2.0|-3.4|0.5|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 52.||0.5|-3.4|
70900150|NCT04270747|141288739|OTHER||Difference between means|-1.5|||||TWO_SIDED|90.0|-3.0|0.0|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 4.||0.0|-3.0|
70900151|NCT04270747|141288739|OTHER||Difference between means|-1.9|||||TWO_SIDED|90.0|-3.6|-0.2|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 8.||-0.2|-3.6|
70900152|NCT04270747|141288739|OTHER||Difference between means|-0.3|||||TWO_SIDED|90.0|-2.1|1.5|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 16.||1.5|-2.1|
70900153|NCT04270747|141288739|OTHER||Difference between means|0.0|||||TWO_SIDED|90.0|-1.9|2.0|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 24.||2.0|-1.9|
70900154|NCT04270747|141288739|OTHER||Difference between means|-1.9|||||TWO_SIDED|90.0|-4.0|0.2|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 32.||0.2|-4.0|
70900155|NCT04270747|141288739|OTHER||Difference between means|0.0|||||TWO_SIDED|90.0|-2.2|2.2|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 40.||2.2|-2.2|
70900156|NCT04270747|141288739|OTHER||Difference between means|-0.6|||||TWO_SIDED|90.0|-2.9|1.7|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 48.||1.7|-2.9|
70900157|NCT04270747|141288739|OTHER||Difference between means|-1.2|||||TWO_SIDED|90.0|-3.5|1.1|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 52.||1.1|-3.5|
70900158|NCT04270747|141288740|OTHER||Risk Difference (RD)|-3.4|||||TWO_SIDED|90.0|-9.8|3.1|||||Estimated using the stratified Newcombe confidence limits (with Mantel-Haenszel weights) adjusting for stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters).|Risk difference in percentage of participants who gained at least 10 letters of vision at Week 8.||3.1|-9.8|
70900159|NCT04270747|141288741|OTHER||Risk Difference (RD)|-5.3|||||TWO_SIDED|90.0|-13.6|2.5|||||Estimated using the stratified Newcombe confidence limits (with Mantel-Haenszel weights) adjusting for stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters).|Risk difference in percentage of participants who gained at least 15 letters of vision at Week 52.||2.5|-13.6|
70900160|NCT04270747|141288741|OTHER||Risk Difference (RD)|-5.2|||||TWO_SIDED|90.0|-14.4|4.2|||||Estimated using the stratified Newcombe confidence limits (with Mantel-Haenszel weights) adjusting for stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters).|Risk difference in percentage of participants who gained at least 15 letters of vision at Week 52.||4.2|-14.4|
70900161|NCT04270747|141288742|OTHER||Difference between means|-0.048|||||TWO_SIDED|90.0|-0.734|0.638|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 8.||0.638|-0.734|
70900162|NCT04270747|141288742|OTHER||Difference between means|0.431|||||TWO_SIDED|90.0|-0.367|1.229|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 16.||1.229|-0.367|
70900163|NCT04270747|141288742|OTHER||Difference between means|0.197|||||TWO_SIDED|90.0|-0.625|1.019|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 24.||1.019|-0.625|
70900164|NCT04270747|141288742|OTHER||Difference between means|0.156|||||TWO_SIDED|2.0|-0.561|0.872|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 52.||0.872|-0.561|
70900165|NCT04270747|141288742|OTHER||Difference between means|0.105|||||TWO_SIDED|90.0|-0.682|0.891|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 8.||0.891|-0.682|
70900166|NCT04270747|141288742|OTHER||Difference between means|0.245|||||TWO_SIDED|90.0|-0.667|1.158|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 16.||1.158|-0.667|
70900167|NCT04270747|141288742|OTHER||Difference between means|-0.116|||||TWO_SIDED|90.0|-1.065|0.834|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 24.||0.834|-1.065|
70900168|NCT04270747|141288742|OTHER||Difference between means|0.647|||||TWO_SIDED|90.0|-0.186|1.479|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 52.||1.479|-0.186|
70900169|NCT04270747|141288743|OTHER||Difference between means|6.2|||||TWO_SIDED|90.0|-5.6|17.9|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 4.||17.9|-5.6|
70900170|NCT04270747|141288743|OTHER||Difference between means|1.3|||||TWO_SIDED|90.0|-11.0|13.5|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 8.||13.5|-11.0|
70900171|NCT04270747|141288743|OTHER||Difference between means|1.9|||||TWO_SIDED|90.0|-12.9|16.6|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 16.||16.6|-12.9|
70900172|NCT04270747|141288743|OTHER||Difference between means|0.1|||||TWO_SIDED|90.0|-14.1|14.4|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 24.||14.4|-14.1|
70900173|NCT04270747|141288743|OTHER||Difference between means|-1.2|||||TWO_SIDED|90.0|-15.3|12.9|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 32.||12.9|-15.3|
70900174|NCT04270747|141288743|OTHER||Difference between means|0.2|||||TWO_SIDED|90.0|-13.7|14.1|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 40.||14.1|-13.7|
70900175|NCT04270747|141288743|OTHER||Difference between means|7.0|||||TWO_SIDED|90.0|-7.4|21.4|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 48.||21.4|-7.4|
70900176|NCT04270747|141288743|OTHER||Difference between means|1.6|||||TWO_SIDED|2.0|-9.3|12.5|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 52.||12.5|-9.3|
70900177|NCT04270747|141288743|OTHER||Difference between means|6.3|||||TWO_SIDED|90.0|-7.4|20.0|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 4.||20.0|-7.4|
70900178|NCT04270747|141288743|OTHER||Difference between means|-5.1|||||TWO_SIDED|90.0|-19.3|9.1|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 8.||9.1|-19.3|
70900179|NCT04270747|141288743|OTHER||Difference between means|-3.8|||||TWO_SIDED|90.0|-20.9|13.3|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 16.||13.3|-20.9|
70900180|NCT04270747|141288743|OTHER||Difference between means|-6.0|||||TWO_SIDED|90.0|-22.6|10.6|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 24.||10.6|-22.6|
70900181|NCT04270747|141288743|OTHER||Difference between means|-7.0|||||TWO_SIDED|90.0|-23.3|9.3|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 32.||9.3|-23.3|
70900182|NCT04270747|141288743|OTHER||Difference between means|-6.5|||||TWO_SIDED|90.0|-22.8|9.8|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 40.||9.8|-22.8|
70900183|NCT04270747|141288743|OTHER||Difference between means|-0.5|||||TWO_SIDED|90.0|-17.3|16.2|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 48.||16.2|-17.3|
70900184|NCT04270747|141288743|OTHER||Difference between means|2.3|||||TWO_SIDED|90.0|-10.5|15.0|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 52.||15.0|-10.5|
70900185|NCT05614089|141288772|SUPERIORITY|||||||0.43||||||Since this is one of two coprimary outcomes (this outcome and % time-in-range), a win (p\<0.025 for benefit) on either outcome will be considered to be a positive trial.|Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % time in serious hypoglycemia at baseline||6-month (primary)||||0.43
70900186|NCT05614089|141288772|SUPERIORITY|||||||0.008||||||Since this is one of two coprimary outcomes (this outcome and % time-in-range), a win (p\<0.025 for benefit) on either outcome will be considered to be a positive trial.|Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % time in serious hypoglycemia at baseline||12-month||||0.008
70900187|NCT05614089|141288773|SUPERIORITY|||||||0.71||||||Since this is one of two coprimary outcomes (this outcome and % time in serious hypoglycemia), a win (p\<0.025 for benefit) on either outcome will be considered to be a positive trial.|Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % TIR at baseline||6-month (primary)||||0.71
70900188|NCT05614089|141288773|SUPERIORITY|||||||0.64||||||Since this is one of two coprimary outcomes (this outcome and % time in serious hypoglycemia), a win (p\<0.025 for benefit) on either outcome will be considered to be a positive trial.|Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % TIR at baseline||12-month||||0.64
70900189|NCT05614089|141288774|SUPERIORITY|||||||0.54|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % time in hypoglycemia at baseline||6-month||||0.54
70900190|NCT05614089|141288774|SUPERIORITY|||||||0.07|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % time in hypoglycemia at baseline||12-month||||0.07
70900191|NCT05614089|141288775|SUPERIORITY|||||||0.58|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % time above range at baseline||6-month||||0.58
70900192|NCT05614089|141288775|SUPERIORITY|||||||0.21|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % time above range at baseline||12-month||||0.21
70900193|NCT05614089|141288776|SUPERIORITY|||||||0.7|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and number of nocturnal events at baseline||6-month||||0.70
70900194|NCT05614089|141288776|SUPERIORITY|||||||0.02|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and number of nocturnal events at baseline||12-month||||0.02
70900195|NCT05614089|141288777|SUPERIORITY|||||||0.81|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and HbA1c at baseline||6-month||||0.81
70900196|NCT05614089|141288777|SUPERIORITY|||||||0.29|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and HbA1c at baseline||12-month||||0.29
70900197|NCT05614089|141288778|SUPERIORITY|||||||0.98|||||||Negative Binomial Regression|Negative binomial regression model adjusted for age at screening and study site||Through 6-month||||0.98
70900198|NCT05614089|141288778|SUPERIORITY|||||||0.61|||||||Negative Binomial Regression|Negative binomial regression model adjusted for age at screening and study site||Through 12-month||||0.61
70900199|NCT05614089|141288779|SUPERIORITY|||||||0.83|||||||Negative Binomial Regression|Negative binomial regression model adjusted for age at screening and study site||Through 6-month||||0.83
70900200|NCT05614089|141288779|SUPERIORITY|||||||0.09|||||||Negative Binomial Regression|Negative binomial regression model adjusted for age at screening and study site||Through 12-month||||0.09
70900201|NCT05614089|141288780|SUPERIORITY|||||||0.95|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and PedsQL 3.2 DM Diabetes Symptoms score at baseline||6-month||||0.95
70900202|NCT05614089|141288780|SUPERIORITY|||||||0.73|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and PedsQL 3.2 DM Diabetes Symptoms score at baseline||12-month||||0.73
70900203|NCT05614089|141288781|SUPERIORITY|||||||0.81|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and PedsQL 3.2 DM Diabetes Management score at baseline||6-month||||0.81
70900204|NCT05614089|141288781|SUPERIORITY|||||||0.44|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and PedsQL 3.2 DM Diabetes Management score at baseline||12-month||||0.44
70900205|NCT05614089|141288782|SUPERIORITY|||||||0.04|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and ITSQ at baseline||6-month||||0.04
70900206|NCT05614089|141288782|SUPERIORITY|||||||0.1|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and ITSQ at baseline||12-month||||0.10
70900207|NCT05701995|141288831|SUPERIORITY||Odds Ratio (OR)|7.7||||0.0001|TWO_SIDED|95.0|2.5|23.6|||Stratified Cochran-Mantel-Haenszel (CMH)|||Full Analysis Set||23.6|2.5|0.0001
70900208|NCT05701995|141288831|SUPERIORITY||Odds Ratio (OR)|8.5||||0.0003|TWO_SIDED|95.0|2.4|30.4|||Stratified Cochran-Mantel-Haenszel (CMH)|||Full Analysis Set Sub-population||30.4|2.4|0.0003
70900209|NCT05701995|141288832|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0107|TWO_SIDED|95.0|1.2|4.4|||Stratified Cochran-Mantel-Haenszel (CMH)|||Full Analysis Set||4.4|1.2|0.0107
70900210|NCT05701995|141288832|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0175|TWO_SIDED|95.0|1.2|4.7|||Stratified Cochran-Mantel-Haenszel (CMH)|||Full Analysis Set Sub-population||4.7|1.2|0.0175
70900211|NCT05701995|141288833|SUPERIORITY||Adjusted Mean Difference|-2.0|||<|0.0001|TWO_SIDED|95.0|-2.9|-1.2|||Covariance model|||Full Analysis Set||-1.2|-2.9|<0.0001
70900212|NCT05701995|141288833|SUPERIORITY||Adjusted Mean Difference|-2.2|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.3|||Covariance model|||Full Analysis Set Sub-population||-1.3|-3.0|<0.0001
70900213|NCT05701995|141288834|SUPERIORITY||Odds Ratio (OR)|5.9||||0.0004|TWO_SIDED|95.0|2.0|17.4|||Stratified Cochran-Mantel-Haenszel (CMH)|||Full Analysis Set Sub-population||17.4|2.0|0.0004
70900214|NCT04506775|141288880|NON_INFERIORITY|As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \<5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively.|Mean Error|0.9|||||TWO_SIDED|||||As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \<5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively.||||||||
70900215|NCT04506775|141288881|NON_INFERIORITY|As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \< 5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively|Mean Error|0.19|||||TWO_SIDED|||||As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \< 5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively|||As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \< 5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively||As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \< 5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively|||
70900216|NCT04058353|141288893|SUPERIORITY||Least Squares (LS) Mean Difference|3.5|||<|0.0001|TWO_SIDED|95.0|2.2|4.7|||Mixed-effects model for repeated measure|||||4.7|2.2|<0.0001
70900217|NCT04058353|141288894|SUPERIORITY||LS Mean Difference|-23.1|||<|0.0001|TWO_SIDED|95.0|-26.1|-20.1|||Mixed-effects model for repeated measure|||||-20.1|-26.1|<0.0001
70900218|NCT04058353|141288896|SUPERIORITY||LS Mean Difference|8.7|||<|0.0001|TWO_SIDED|95.0|5.3|12.1|||Mixed-effects model for repeated measure|||||12.1|5.3|<0.0001
70900219|NCT01349920|141288908|SUPERIORITY_OR_OTHER|||||||0.071|||||||Multiple Linear Regression|||Week 6||||0.071
70900220|NCT01349920|141288908|SUPERIORITY_OR_OTHER|||||||0.381|||||||Multiple Linear Regression|||Week 22||||0.381
70900221|NCT00696384|141288927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.78|||<|0.001|TWO_SIDED|95.0|-9.78|-5.78||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Includes participants with both a double-blind baseline and postbaseline value.|ANCOVA|||||-5.78|-9.78|<0.001
70900222|NCT00696384|141288928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.38|||<|0.001|TWO_SIDED|95.0|-15.47|-9.29||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Includes participants with both a double-blind baseline and postbaseline value.|ANCOVA|||||-9.29|-15.47|<0.001
70900223|NCT05361655|141288985|OTHER||Hazard Ratio (HR)|0.76|||<|0.0001|TWO_SIDED|95.0|0.65|0.87|||Cox proportional hazard model|||||0.87|0.65|<0.0001
70900224|NCT05361655|141288986|OTHER||Hazard Ratio (HR)|0.7|||<|0.0001|TWO_SIDED|95.0|0.62|0.76|||Cox proportional hazards model|||||0.76|0.62|<0.0001
70900225|NCT05361655|141288988|OTHER||||||<|0.0001|||||||score test|||||||<0.0001
70900226|NCT05361655|141288991|OTHER||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.6|0.72|||Cox proportional hazard model|||||0.72|0.60|<0.0001
70900227|NCT05361655|141288992|OTHER||Hazard Ratio (HR)|0.56|||<|0.0001|TWO_SIDED|95.0|0.51|0.62|||Cox proportional hazard model|||||0.62|0.51|<0.0001
70900228|NCT05361655|141288993|OTHER||Hazard Ratio (HR)|0.77|||<|0.0001|TWO_SIDED|95.0|0.69|0.86|||Cox proportional hazard model|||||0.86|0.69|<0.0001
70900229|NCT05361655|141288994|OTHER||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.54|0.7|||Cox proportional hazards model|||||0.70|0.54|<0.0001
70900230|NCT01984697|141288995|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the Geometric Mean Titer (GMT) ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.15|||<|0.001|TWO_SIDED|95.0|1.83|2.53|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.53|1.83|<0.001
70900231|NCT01984697|141288995|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.02|||<|0.001|TWO_SIDED|95.0|1.73|2.36|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.36|1.73|<0.001
70900232|NCT01984697|141288995|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|3.47|||<|0.001|TWO_SIDED|95.0|2.93|4.11|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||4.11|2.93|<0.001
70900233|NCT01984697|141288996|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.0|||<|0.001|TWO_SIDED|95.0|-1.8|2.0|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.0|-1.8|<0.001
70900234|NCT01984697|141288996|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.3|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.3|-1.0|<0.001
70900235|NCT01984697|141288996|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.1|2.3|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.3|-1.1|<0.001
70900236|NCT01984697|141288997|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.39|||<|0.001|TWO_SIDED|95.0|2.03|2.82|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.82|2.03|<0.001
70900237|NCT01984697|141288997|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.45|||<|0.001|TWO_SIDED|95.0|2.09|2.88|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.88|2.09|<0.001
70900238|NCT01984697|141288997|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|5.07|||<|0.001|TWO_SIDED|95.0|4.32|5.94|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||5.94|4.32|<0.001
70900239|NCT01984697|141288998|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.54|||<|0.001|TWO_SIDED|95.0|2.14|3.0|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.00|2.14|<0.001
70900240|NCT01984697|141288998|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.69|||<|0.001|TWO_SIDED|95.0|2.29|3.15|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.15|2.29|<0.001
70900241|NCT01984697|141288998|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|4.54|||<|0.001|TWO_SIDED|95.0|3.84|5.37|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||5.37|3.84|<0.001
70900242|NCT01984697|141288999|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.46|||<|0.001|TWO_SIDED|95.0|2.05|2.96|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.96|2.05|<0.001
70900243|NCT01984697|141288999|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.44|||<|0.001|TWO_SIDED|95.0|2.04|2.92|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.92|2.04|<0.001
70900244|NCT01984697|141288999|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|3.69|||<|0.001|TWO_SIDED|95.0|3.06|4.45|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||4.45|3.06|<0.001
70900245|NCT01984697|141289000|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.51|||<|0.001|TWO_SIDED|95.0|2.1|3.0|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.00|2.10|<0.001
70900246|NCT01984697|141289000|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.62|||<|0.001|TWO_SIDED|95.0|2.2|3.12|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.12|2.20|<0.001
70900247|NCT01984697|141289000|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|3.7|||<|0.001|TWO_SIDED|95.0|3.08|4.45|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||4.45|3.08|<0.001
70900248|NCT01984697|141289001|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.96|||<|0.001|TWO_SIDED|95.0|2.5|3.5|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.50|2.50|<0.001
70900249|NCT01984697|141289001|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.99|||<|0.001|TWO_SIDED|95.0|2.55|3.5|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.50|2.55|<0.001
70900250|NCT01984697|141289001|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|6.31|||<|0.001|TWO_SIDED|95.0|5.36|7.43|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||7.43|5.36|<0.001
70900251|NCT01984697|141289002|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|1.67|||<|0.001|TWO_SIDED|95.0|1.38|2.03|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.03|1.38|<0.001
70900252|NCT01984697|141289002|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|1.65|||<|0.001|TWO_SIDED|95.0|1.37|1.99|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||1.99|1.37|<0.001
70900253|NCT01984697|141289002|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|1.96|||<|0.001|TWO_SIDED|95.0|1.61|2.37|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.37|1.61|<0.001
70900254|NCT01984697|141289003|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|1.6|||<|0.001|TWO_SIDED|95.0|1.36|1.87|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||1.87|1.36|<0.001
70900255|NCT01984697|141289003|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|1.76|||<|0.001|TWO_SIDED|95.0|1.51|2.05|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.05|1.51|<0.001
70900256|NCT01984697|141289003|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|3.08|||<|0.001|TWO_SIDED|95.0|2.64|3.61|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.61|2.64|<0.001
70900257|NCT01984697|141289004|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.55|||<|0.001|TWO_SIDED|95.0|2.15|3.01|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.01|2.15|<0.001
70900258|NCT01984697|141289004|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.7|||<|0.001|TWO_SIDED|95.0|2.3|3.16|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.16|2.30|<0.001
70900259|NCT01984697|141289004|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|4.98|||<|0.001|TWO_SIDED|95.0|4.23|5.86|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||5.86|4.23|<0.001
70900260|NCT01984697|141289005|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.1|2.3|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.3|-1.1|<0.001
70900261|NCT01984697|141289005|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.3|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.3|-1.0|<0.001
70900262|NCT01984697|141289005|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.1|2.3|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.3|-1.1|<0.001
70900263|NCT01984697|141289006|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.2|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.2|-1.0|<0.001
70900264|NCT01984697|141289006|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.2|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.2|-1.0|<0.001
70900265|NCT01984697|141289006|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.2|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.2|-1.0|<0.001
70900266|NCT01984697|141289007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|1.5|||<|0.001|TWO_SIDED|95.0|0.1|3.8|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||3.8|0.1|<0.001
70900267|NCT01984697|141289007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|1.5|||<|0.001|TWO_SIDED|95.0|0.1|3.8|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||3.8|0.1|<0.001
70900268|NCT01984697|141289007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|1.5|||<|0.001|TWO_SIDED|95.0|0.1|3.8|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||3.8|0.1|<0.001
70900269|NCT01984697|141289008|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.0|||<|0.001|TWO_SIDED|95.0|-1.7|1.8|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||1.8|-1.7|<0.001
70900270|NCT01984697|141289008|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.0|<0.001
70900271|NCT01984697|141289008|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.0|<0.001
70900272|NCT01984697|141289009|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.0|||<|0.001|TWO_SIDED|95.0|-1.7|1.7|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||1.7|-1.7|<0.001
70900273|NCT01984697|141289009|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.0|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.0|-1.0|<0.001
70900274|NCT01984697|141289009|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.1|2.0|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.0|-1.1|<0.001
70900275|NCT01984697|141289010|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|1.4|||<|0.001|TWO_SIDED|95.0|-0.7|4.0|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||4.0|-0.7|<0.001
70900276|NCT01984697|141289010|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|1.4|||<|0.001|TWO_SIDED|95.0|-0.7|4.0|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||4.0|-0.7|<0.001
70900277|NCT01984697|141289010|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|2.1|||<|0.001|TWO_SIDED|95.0|0.7|4.6|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||4.6|0.7|<0.001
70900278|NCT01984697|141289011|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.0|||<|0.001|TWO_SIDED|95.0|-1.7|1.7|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||1.7|-1.7|<0.001
70900279|NCT01984697|141289011|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.0|<0.001
70900280|NCT01984697|141289011|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.0|<0.001
70900281|NCT01984697|141289012|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.0|<0.001
70900282|NCT01984697|141289012|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.0|<0.001
70900283|NCT01984697|141289012|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.1|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.1|<0.001
70900284|NCT03928028|141289059|SUPERIORITY|||||||0.507||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.507
70900285|NCT03928028|141289059|SUPERIORITY|||||||0.017||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRT||||.017
70900286|NCT03928028|141289059|SUPERIORITY|||||||0.139||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||.139
70900287|NCT03928028|141289060|SUPERIORITY|||||||0.389|||||||generalized estimating equation|||This analysis compare mothers in FBT to mothers in FBT+CRTp||||.389
70900288|NCT03928028|141289060|SUPERIORITY|||||||0.447||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRT||||.447
70900289|NCT03928028|141289060|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||<.001
70900290|NCT03928028|141289061|SUPERIORITY|||||||0.778||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.778
70900291|NCT03928028|141289061|SUPERIORITY|||||||0.297||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.297
70900292|NCT03928028|141289061|SUPERIORITY|||||||0.062||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||.062
70900293|NCT03928028|141289062|SUPERIORITY|||||||0.069||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.069
70900294|NCT03928028|141289062|SUPERIORITY|||||||0.323||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRT||||.323
70900295|NCT03928028|141289062|SUPERIORITY|||||||0.225|||||||generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||.225
70900296|NCT03928028|141289063|SUPERIORITY|||||||0.196||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.196
70900297|NCT03928028|141289063|SUPERIORITY|||||||0.812||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRT||||.812
70900298|NCT03928028|141289063|SUPERIORITY|||||||0.499||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||.499
70900299|NCT03928028|141289064|SUPERIORITY|||||||0.446||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.446
70900300|NCT03928028|141289064|SUPERIORITY|||||||0.647|||||||generalized estimating equation|||This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRT||||.647
70900301|NCT03928028|141289064|SUPERIORITY|||||||0.765||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||.765
70900302|NCT03928028|141289065|SUPERIORITY|||||||0.425||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.425
70900303|NCT03928028|141289065|SUPERIORITY|||||||0.63|||||||generalized estimating equation|||This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRT||||.630
70900304|NCT03928028|141289065|SUPERIORITY|||||||0.854||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||.854
70900305|NCT02802501|141289067|SUPERIORITY||Hazard Ratio (HR)|0.444|||<|0.001|TWO_SIDED|95.0|0.285|0.693|||Cox Proportional Hazard||If hazard ratio was found to be \<1 then there are lower chances of relapse with Tafenoquine+DHA-PQP compared to DHA-PQP only.|||0.693|0.285|<0.001
70900306|NCT02802501|141289068|SUPERIORITY||Hazard Ratio (HR)|1.722|||||TWO_SIDED|95.0|1.031|2.875|||||If hazard ratio was found to be \>1 then there are higher chances of relapse with Tafenoquine+DHA-PQP compared to Primaquine+DHA-PQP.|||2.875|1.031|
70900307|NCT02802501|141289069|SUPERIORITY||Hazard Ratio (HR)|0.258|||||TWO_SIDED|95.0|0.155|0.431|||||If hazard ratio was found to be \<1 then there are lower chances of relapse with Primaquine+DHA-PQP compared to DHA-PQP only.|||0.431|0.155|
70900308|NCT02802501|141289070|SUPERIORITY||Hazard Ratio (HR)|0.433|||||TWO_SIDED|95.0|0.273|0.686|||||If hazard ratio was found to be \<1 then there are lower chances of relapse with Tafenoquine+DHA-PQP compared to DHA-PQP only.|||0.686|0.273|
70900309|NCT01544998|141289100|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||t-test, 2 sided|||This was a within PSD reporting group comparison; between PSD and PDD groups were not compared.||||0.26
70900310|NCT01544998|141289101|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||t-test, 2 sided|||This was a within PDD reporting group comparison; between PSD and PDD groups were not compared.||||0.90
70900311|NCT01544998|141289102|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||This was a within PSD reporting group comparison; between PSD and PDD groups were not compared.||||0.003
70900312|NCT01544998|141289103|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||This was a within PDD reporting group comparison; between PSD and PDD groups were not compared.||||0.14
70900313|NCT01544998|141289104|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||This was a within PSD reporting group comparison; between PSD and PDD groups were not compared.||||<0.001
70900314|NCT01544998|141289105|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||This was a within PDD reporting group comparison; between PSD and PDD groups were not compared.||||<0.001
70900315|NCT00514683|141289111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.052||0.853|TWO_SIDED|95.0|-0.086|0.118||The p-value presented is computed in the course of the closing testing procedure.|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.118|-0.086|0.8530
70900316|NCT00514683|141289111|SUPERIORITY_OR_OTHER|||||||0.7558||||||The p-value from the hierarchical testing procedure was calculated as a sensitivity analysis|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.||||||0.7558
70900317|NCT00514683|141289111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.051||0.792|TWO_SIDED|95.0|-0.119|0.08||The p-value presented is computed in the course of the closing testing procedure.|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.080|-0.119|0.7920
70900318|NCT00514683|141289111|SUPERIORITY_OR_OTHER|||||||0.6991||||||The p-value from the hierarchical testing procedure was calculated as a sensitivity analysis|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.||||||0.6991
70900319|NCT00514683|141289111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028|STANDARD_ERROR_OF_MEAN|0.051||0.853|TWO_SIDED|95.0|-0.071|0.128||The p-value presented is computed in the course of the closing testing procedure.|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.128|-0.071|0.8530
70900320|NCT00514683|141289111|SUPERIORITY_OR_OTHER|||||||0.5736||||||Additionally the p-value from the hierarchical testing procedure was calculated as a sensitivity analysis|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.||||||0.5736
70900321|NCT00514683|141289111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.053||0.0639|TWO_SIDED|95.0|0.027|0.235||The p-value presented is computed in the course of the closing testing procedure.|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.235|0.027|0.0639
70900322|NCT00514683|141289111|SUPERIORITY_OR_OTHER|||||||0.0136||||||Additionally the p-value from the hierarchical testing procedure was calculated as a sensitivity analysis|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.||||||0.0136
70900323|NCT00514683|141289112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.43|STANDARD_ERROR_OF_MEAN|1.312||0.2774|TWO_SIDED|95.0|-1.15|4.01|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||4.01|-1.15|0.2774
70900324|NCT00514683|141289112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|1.312||0.4014|TWO_SIDED|95.0|-1.48|3.68|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||3.68|-1.48|0.4014
70900325|NCT00514683|141289112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.86|STANDARD_ERROR_OF_MEAN|1.324||0.0314|TWO_SIDED|95.0|0.26|5.46|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||5.46|0.26|0.0314
70900326|NCT00514683|141289112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.97|STANDARD_ERROR_OF_MEAN|1.319||0.0002|TWO_SIDED|95.0|2.37|7.56|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||7.56|2.37|0.0002
70900327|NCT00514683|141289113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.046||0.3644|TWO_SIDED|95.0|-0.05|0.13|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.13|-0.05|0.3644
70900328|NCT00514683|141289113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.046||0.4525|TWO_SIDED|95.0|-0.06|0.13|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.13|-0.06|0.4525
70900329|NCT00514683|141289113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.046||0.0471|TWO_SIDED|95.0|0.0|0.18|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.18|0.00|0.0471
70900330|NCT00514683|141289113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.046||0.0004|TWO_SIDED|95.0|0.08|0.26|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.26|0.08|0.0004
70900331|NCT00514683|141289114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91|STANDARD_ERROR_OF_MEAN|1.702||0.592|TWO_SIDED|95.0|-2.43|4.26|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||4.26|-2.43|0.5920
70900332|NCT00514683|141289114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|1.702||0.6155|TWO_SIDED|95.0|-2.49|4.2|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||4.20|-2.49|0.6155
70900333|NCT00514683|141289114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.81|STANDARD_ERROR_OF_MEAN|1.716||0.0271|TWO_SIDED|95.0|0.43|7.18|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||7.18|0.43|0.0271
70900334|NCT00514683|141289114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.47|STANDARD_ERROR_OF_MEAN|1.71||0.0015|TWO_SIDED|95.0|2.11|8.83|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||8.83|2.11|0.0015
70900335|NCT00514683|141289115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99|STANDARD_ERROR_OF_MEAN|1.692||0.5601|TWO_SIDED|95.0|-2.34|4.31||ANCOVA with fixed terms for treatment, baseline, region.|ANCOVA||Mean difference to placebo is calculated. Negative change indicates worsening.|||4.31|-2.34|0.5601
70900336|NCT00514683|141289115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|1.694||0.6366|TWO_SIDED|95.0|-2.53|4.13|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||4.13|-2.53|0.6366
70900337|NCT00514683|141289115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.84|STANDARD_ERROR_OF_MEAN|1.702||0.0246|TWO_SIDED|95.0|0.49|7.18|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||7.18|0.49|0.0246
70900338|NCT00514683|141289115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.44|STANDARD_ERROR_OF_MEAN|1.7||0.0015|TWO_SIDED|95.0|2.1|8.78|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||8.78|2.10|0.0015
70900339|NCT00514683|141289116|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.911||||0.7543|TWO_SIDED|95.0|0.506|1.637|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.637|0.506|0.7543
70900340|NCT00514683|141289116|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.136||||0.6704|TWO_SIDED|95.0|0.631|2.045|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||2.045|0.631|0.6704
70900341|NCT00514683|141289116|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.657||||0.1649|TWO_SIDED|95.0|0.363|1.189|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.189|0.363|0.1649
70900342|NCT00514683|141289116|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.415||||0.0041|TWO_SIDED|95.0|0.227|0.757|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||0.757|0.227|0.0041
70900343|NCT00514683|141289117|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.278||||0.5882|TWO_SIDED|95.0|0.526|3.102|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||3.102|0.526|0.5882
70900344|NCT00514683|141289117|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29||||0.0653|TWO_SIDED|95.0|0.078|1.081|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.081|0.078|0.0653
70900345|NCT00514683|141289117|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35||||0.0847|TWO_SIDED|95.0|0.106|1.154|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.154|0.106|0.0847
70900346|NCT00514683|141289117|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.732||||0.5383|TWO_SIDED|95.0|0.271|1.977|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.977|0.271|0.5383
70900347|NCT00514683|141289118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.483||0.3658|TWO_SIDED|95.0|-0.51|1.39|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||1.39|-0.51|0.3658
70900348|NCT00514683|141289118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.478||0.4956|TWO_SIDED|95.0|-0.61|1.27|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||1.27|-0.61|0.4956
70900349|NCT00514683|141289118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|0.482||0.0051|TWO_SIDED|95.0|0.41|2.31|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||2.31|0.41|0.0051
70900350|NCT00514683|141289118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|0.483||0.0211|TWO_SIDED|95.0|0.17|2.07|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||2.07|0.17|0.0211
70900351|NCT00514683|141289119|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.428||||0.1021|TWO_SIDED|95.0|0.155|1.184|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.184|0.155|0.1021
70900352|NCT00514683|141289119|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.682||||0.4318|TWO_SIDED|95.0|0.262|1.773|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.773|0.262|0.4318
70900353|NCT00514683|141289119|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.412||||0.0934|TWO_SIDED|95.0|0.146|1.161|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.161|0.146|0.0934
70900354|NCT00514683|141289119|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.313||||0.0317|TWO_SIDED|95.0|0.108|0.903|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||0.903|0.108|0.0317
70900355|NCT00514683|141289120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|2.33||0.6443|TWO_SIDED|95.0|-5.66|3.51|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||3.51|-5.66|0.6443
70900356|NCT00514683|141289120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31|STANDARD_ERROR_OF_MEAN|2.28||0.5656|TWO_SIDED|95.0|-5.8|3.18|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||3.18|-5.80|0.5656
70900357|NCT00514683|141289120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|2.24||0.9181|TWO_SIDED|95.0|-4.18|4.64|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||4.64|-4.18|0.9181
70900358|NCT00514683|141289120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|2.387||0.697|TWO_SIDED|95.0|-3.77|5.63|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||5.63|-3.77|0.6970
70900359|NCT00514683|141289121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|2.49||0.9811|TWO_SIDED|95.0|-4.84|4.96|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||4.96|-4.84|0.9811
70900360|NCT00514683|141289121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01|STANDARD_ERROR_OF_MEAN|2.412||0.6772|TWO_SIDED|95.0|-3.74|5.75|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||5.75|-3.74|0.6772
70900361|NCT00514683|141289121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|2.379||0.8631|TWO_SIDED|95.0|-4.27|5.09|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||5.09|-4.27|0.8631
70900362|NCT00514683|141289121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.35|STANDARD_ERROR_OF_MEAN|2.523||0.5942|TWO_SIDED|95.0|-3.62|6.31|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||6.31|-3.62|0.5942
70900363|NCT00514683|141289122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|0.715||0.2716|TWO_SIDED|95.0|-0.62|2.19|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||2.19|-0.62|0.2716
70900364|NCT00514683|141289122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.696||0.7871|TWO_SIDED|95.0|-1.18|1.56|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||1.56|-1.18|0.7871
70900365|NCT00514683|141289122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.685||0.8721|TWO_SIDED|95.0|-1.46|1.24|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||1.24|-1.46|0.8721
70900366|NCT00514683|141289122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.734||0.8523|TWO_SIDED|95.0|-1.58|1.31|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||1.31|-1.58|0.8523
70900367|NCT00514683|141289123|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.093||||0.7997|TWO_SIDED|95.0|0.549|2.175|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||2.175|0.549|0.7997
70900368|NCT00514683|141289123|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.916||||0.7989|TWO_SIDED|95.0|0.467|1.797|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.797|0.467|0.7989
70900369|NCT00514683|141289123|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.4596|TWO_SIDED|95.0|0.403|1.508|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.508|0.403|0.4596
70900370|NCT00514683|141289123|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.665||||0.2548|TWO_SIDED|95.0|0.33|1.341|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.341|0.330|0.2548
70900371|NCT00514683|141289124|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.051||||0.8887|TWO_SIDED|95.0|0.521|2.122|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||2.122|0.521|0.8887
70900372|NCT00514683|141289124|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.216||||0.5758|TWO_SIDED|95.0|0.613|2.41|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||2.410|0.613|0.5758
70900373|NCT00514683|141289124|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.993||||0.9829|TWO_SIDED|95.0|0.506|1.949|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.949|0.506|0.9829
70900374|NCT00514683|141289124|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.972||||0.9375|TWO_SIDED|95.0|0.476|1.985|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.985|0.476|0.9375
70900375|NCT00514683|141289125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.1456||0.4998|TWO_SIDED|95.0|-0.188|0.385|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.385|-0.188|0.4998
70900376|NCT00514683|141289125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.155|STANDARD_ERROR_OF_MEAN|0.1399||0.2679|TWO_SIDED|95.0|-0.43|0.12|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.120|-0.430|0.2679
70900377|NCT00514683|141289125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.5678|TWO_SIDED|95.0|-0.355|0.195|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.195|-0.355|0.5678
70900378|NCT00514683|141289125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.121|STANDARD_ERROR_OF_MEAN|0.1448||0.4053|TWO_SIDED|95.0|-0.406|0.164|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.164|-0.406|0.4053
70900379|NCT00514683|141289126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.892||||0.7307|TWO_SIDED|95.0|0.465|1.71|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.710|0.465|0.7307
70900380|NCT00514683|141289126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.317||||0.3869|TWO_SIDED|95.0|0.706|2.458|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||2.458|0.706|0.3869
70900381|NCT00514683|141289126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.931||||0.8237|TWO_SIDED|95.0|0.498|1.741|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.741|0.498|0.8237
70900382|NCT00514683|141289126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.676||||0.1177|TWO_SIDED|95.0|0.878|3.202|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||3.202|0.878|0.1177
70900383|NCT00514683|141289127|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-11.24|STANDARD_ERROR_OF_MEAN|17.089||0.5111|TWO_SIDED|95.0|-44.86|22.37|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||22.37|-44.86|0.5111
70900384|NCT00514683|141289127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.17|STANDARD_ERROR_OF_MEAN|16.234||0.4176|TWO_SIDED|95.0|-45.11|18.76|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||18.76|-45.11|0.4176
70900385|NCT00514683|141289127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13|STANDARD_ERROR_OF_MEAN|16.506||0.9454|TWO_SIDED|95.0|-33.6|31.34|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||31.34|-33.60|0.9454
70900386|NCT00514683|141289127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.32|STANDARD_ERROR_OF_MEAN|16.98||0.7101|TWO_SIDED|95.0|-27.08|39.72|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||39.72|-27.08|0.7101
70900387|NCT00514683|141289128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.055|STANDARD_ERROR_OF_MEAN|0.2271||0.809|TWO_SIDED|95.0|-0.392|0.502|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.502|-0.392|0.8090
70900388|NCT00514683|141289128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.182|STANDARD_ERROR_OF_MEAN|0.2158||0.3995|TWO_SIDED|95.0|-0.606|0.242|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.242|-0.606|0.3995
70900389|NCT00514683|141289128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.2193||0.8822|TWO_SIDED|95.0|-0.399|0.464|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.464|-0.399|0.8822
70900390|NCT00514683|141289128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.141|STANDARD_ERROR_OF_MEAN|0.2257||0.5338|TWO_SIDED|95.0|-0.584|0.303|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.303|-0.584|0.5338
70900391|NCT00514683|141289129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.3272||0.7329|TWO_SIDED|95.0|-0.532|0.755|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.755|-0.532|0.7329
70900392|NCT00514683|141289129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.078|STANDARD_ERROR_OF_MEAN|0.3109||0.8009|TWO_SIDED|95.0|-0.69|0.533|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.533|-0.690|0.8009
70900393|NCT00514683|141289129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.3159||0.6358|TWO_SIDED|95.0|-0.771|0.472|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.472|-0.771|0.6358
70900394|NCT00514683|141289129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.333|STANDARD_ERROR_OF_MEAN|0.3252||0.3064|TWO_SIDED|95.0|-0.973|0.307|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.307|-0.973|0.3064
70900395|NCT00514683|141289130|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.014||||0.9646|TWO_SIDED|95.0|0.54|1.906|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo. Negative change indicates worsening.|||1.906|0.540|0.9646
70900396|NCT00514683|141289130|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.994||||0.985|TWO_SIDED|95.0|0.536|1.844|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo. Negative change indicates worsening.|||1.844|0.536|0.9850
70900397|NCT00514683|141289130|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.123||||0.7136|TWO_SIDED|95.0|0.604|2.089|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo. Negative change indicates worsening.|||2.089|0.604|0.7136
70900398|NCT00514683|141289130|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.551||||0.1705|TWO_SIDED|95.0|0.828|2.906|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo. Negative change indicates worsening.|||2.906|0.828|0.1705
70900399|NCT00514683|141289131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|0.68||0.0479|TWO_SIDED|95.0|-2.69|-0.01|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated.|||-0.01|-2.69|0.0479
70900400|NCT00514683|141289131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24|STANDARD_ERROR_OF_MEAN|0.68||0.0685|TWO_SIDED|95.0|-2.58|0.09|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated.|||0.09|-2.58|0.0685
70900401|NCT00514683|141289131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.77|STANDARD_ERROR_OF_MEAN|0.684||0.0099|TWO_SIDED|95.0|-3.12|-0.43|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated.|||-0.43|-3.12|0.0099
70900402|NCT00514683|141289131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.67|STANDARD_ERROR_OF_MEAN|0.683||0.0152|TWO_SIDED|95.0|-3.01|-0.32|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated.|||-0.32|-3.01|0.0152
70900403|NCT00514683|141289132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|2.253||0.725|TWO_SIDED|95.0|-5.22|3.64|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||3.64|-5.22|0.7250
70900404|NCT00514683|141289132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.28|STANDARD_ERROR_OF_MEAN|2.213||0.1389|TWO_SIDED|95.0|-7.63|1.07|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||1.07|-7.63|0.1389
70900405|NCT00514683|141289132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.98|STANDARD_ERROR_OF_MEAN|2.221||0.0741|TWO_SIDED|95.0|-8.35|0.39|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.39|-8.35|0.0741
70900406|NCT00514683|141289132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.12|STANDARD_ERROR_OF_MEAN|2.262||0.0071|TWO_SIDED|95.0|-10.57|-1.67|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||-1.67|-10.57|0.0071
70900407|NCT00514683|141289133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.06|STANDARD_ERROR_OF_MEAN|3.183||0.337|TWO_SIDED|95.0|-9.32|3.2|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||3.20|-9.32|0.3370
70900408|NCT00514683|141289133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.34|STANDARD_ERROR_OF_MEAN|3.126||0.1659|TWO_SIDED|95.0|-10.49|1.81|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||1.81|-10.49|0.1659
70900409|NCT00514683|141289133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.12|STANDARD_ERROR_OF_MEAN|3.138||0.1897|TWO_SIDED|95.0|-10.29|2.05|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||2.05|-10.29|0.1897
70900410|NCT00514683|141289133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|3.184||0.0028|TWO_SIDED|95.0|-15.86|-3.34|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||-3.34|-15.86|0.0028
70900411|NCT00514683|141289134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|2.586||0.8458|TWO_SIDED|95.0|-5.59|4.58|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||4.58|-5.59|0.8458
70900412|NCT00514683|141289134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.48|STANDARD_ERROR_OF_MEAN|2.54||0.3286|TWO_SIDED|95.0|-7.48|2.51|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||2.51|-7.48|0.3286
70900413|NCT00514683|141289134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.42|STANDARD_ERROR_OF_MEAN|2.548||0.1799|TWO_SIDED|95.0|-8.43|1.59|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||1.59|-8.43|0.1799
70900414|NCT00514683|141289134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.35|STANDARD_ERROR_OF_MEAN|2.597||0.0948|TWO_SIDED|95.0|-9.46|0.76|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.76|-9.46|0.0948
70900415|NCT00514683|141289135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|2.484||0.9708|TWO_SIDED|95.0|-4.98|4.79|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||4.79|-4.98|0.9708
70900416|NCT00514683|141289135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.94|STANDARD_ERROR_OF_MEAN|2.44||0.1069|TWO_SIDED|95.0|-8.74|0.85|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.85|-8.74|0.1069
70900417|NCT00514683|141289135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.49|STANDARD_ERROR_OF_MEAN|2.453||0.0682|TWO_SIDED|95.0|-9.31|0.34|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.34|-9.31|0.0682
70900418|NCT00514683|141289135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.16|STANDARD_ERROR_OF_MEAN|2.494||0.0043|TWO_SIDED|95.0|-12.06|-2.26|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||-2.26|-12.06|0.0043
70900419|NCT00514683|141289136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.54||||0.2698|TWO_SIDED|95.0|0.72|3.31|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel test to adjust for region effect.|In case of missing data, patient has been set to non-responder. Odds ratio lower than 1 favours the treatment group over placebo.|||3.31|0.72|0.2698
70900420|NCT00514683|141289136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9||||0.0891|TWO_SIDED|95.0|0.9|4.01|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel test to adjust for region effect.|In case of missing data, patient has been set to non-responder. Odds ratio lower than 1 favours the treatment group over placebo.|||4.01|0.90|0.0891
70900421|NCT00514683|141289136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.7||||0.0069|TWO_SIDED|95.0|1.29|5.66|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel test to adjust for region effect.|In case of missing data, patient has been set to non-responder. Odds ratio lower than 1 favours the treatment group over placebo.|||5.66|1.29|0.0069
70900422|NCT00514683|141289136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.0341|TWO_SIDED|95.0|1.05|4.61|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel test to adjust for region effect.|In case of missing data, patient has been set to non-responder. Odds ratio lower than 1 favours the treatment group over placebo.|||4.61|1.05|0.0341
70900423|NCT00514683|141289137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.1015||0.8288|TWO_SIDED|95.0|-0.178|0.222|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.222|-0.178|0.8288
70900424|NCT00514683|141289137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.0974||0.1506|TWO_SIDED|95.0|-0.051|0.332|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.332|-0.051|0.1506
70900425|NCT00514683|141289137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.0977||0.1059|TWO_SIDED|95.0|-0.034|0.351|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.351|-0.034|0.1059
70900426|NCT00514683|141289137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.358|STANDARD_ERROR_OF_MEAN|0.1008||0.0004|TWO_SIDED|95.0|0.16|0.556|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.556|0.160|0.0004
70900427|NCT00514683|141289138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.068||0.7789|TWO_SIDED|95.0|-0.153|0.115|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.115|-0.153|0.7789
70900428|NCT00514683|141289138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.066|STANDARD_ERROR_OF_MEAN|0.0652||0.3149|TWO_SIDED|95.0|-0.063|0.194|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.194|-0.063|0.3149
70900429|NCT00514683|141289138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.025|STANDARD_ERROR_OF_MEAN|0.0654||0.7062|TWO_SIDED|95.0|-0.104|0.153|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.153|-0.104|0.7062
70900430|NCT00514683|141289138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.0675||0.0703|TWO_SIDED|95.0|-0.01|0.255|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.255|-0.010|0.0703
70900431|NCT00514683|141289139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.0884||0.4792|TWO_SIDED|95.0|-0.111|0.236|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.236|-0.111|0.4792
70900432|NCT00514683|141289139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.0839||0.2221|TWO_SIDED|95.0|-0.062|0.268|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.268|-0.062|0.2221
70900433|NCT00514683|141289139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.0843||0.151|TWO_SIDED|95.0|-0.044|0.287|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.287|-0.044|0.1510
70900434|NCT00514683|141289139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.337|STANDARD_ERROR_OF_MEAN|0.0874||0.0001|TWO_SIDED|95.0|0.165|0.509|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.509|0.165|0.0001
70900435|NCT00514683|141289140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.0609||0.1129|TWO_SIDED|95.0|-0.023|0.217|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.217|-0.023|0.1129
70900436|NCT00514683|141289140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.0584||0.1498|TWO_SIDED|95.0|-0.031|0.199|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.199|-0.031|0.1498
70900437|NCT00514683|141289140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.109|STANDARD_ERROR_OF_MEAN|0.0585||0.0632|TWO_SIDED|95.0|-0.006|0.224|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.224|-0.006|0.0632
70900438|NCT00514683|141289140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.201|STANDARD_ERROR_OF_MEAN|0.0604||0.0009|TWO_SIDED|95.0|0.083|0.32|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.320|0.083|0.0009
70900439|NCT00514683|141289141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.033|STANDARD_ERROR_OF_MEAN|0.0676||0.6306|TWO_SIDED|95.0|-0.165|0.1|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.100|-0.165|0.6306
70900440|NCT00514683|141289141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.065||0.7426|TWO_SIDED|95.0|-0.149|0.106|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.106|-0.149|0.7426
70900441|NCT00514683|141289141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.0651||0.9209|TWO_SIDED|95.0|-0.134|0.121|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.121|-0.134|0.9209
70900442|NCT00514683|141289141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.0671||0.7701|TWO_SIDED|95.0|-0.112|0.152|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.152|-0.112|0.7701
70900443|NCT00514683|141289142|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.83||||0.6671|TWO_SIDED|95.0|0.36|1.93||Based on the statistic of ln(risk ratio) having a normal distribution N\[0,\[ (1/number with at least one exacerbation in Nintedanib group) + (1//number with at least one exacerbation in placebo) \] \]|Negative binomial model|Default log link function and adjusted for an off-set variable (logarithm of the follow-up time), for gender, height, age and region as fixed effects.|Risk ratio lower than 1 favours the treatment group over placebo.|||1.93|0.36|0.6671
70900444|NCT00514683|141289142|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.8||||0.5926|TWO_SIDED|95.0|0.34|1.84||Based on the statistic of ln(risk ratio) having a normal distribution N\[0,\[ (1/number with at least one exacerbation in Nintedanib group) + (1//number with at least one exacerbation in placebo) \] \]|Negative binomial model|Default log link function and adjusted for an off-set variable (logarithm of the follow-up time), for gender, height, age and region as fixed effects.|Risk ratio lower than 1 favours the treatment group over placebo.|||1.84|0.34|0.5926
70900445|NCT00514683|141289142|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.48||||0.1381|TWO_SIDED|95.0|0.18|1.27||Based on the statistic of ln(risk ratio) having a normal distribution N\[0,\[ (1/number with at least one exacerbation in Nintedanib group) + (1//number with at least one exacerbation in placebo) \] \]|Negative binomial model|Default log link function and adjusted for an off-set variable (logarithm of the follow-up time), for gender, height, age and region as fixed effects.|Risk ratio lower than 1 favours the treatment group over placebo.|||1.27|0.18|0.1381
70900446|NCT00514683|141289142|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.16||||0.015|TWO_SIDED|95.0|0.03|0.7||Based on the statistic of ln(risk ratio) having a normal distribution N\[0,\[ (1/number with at least one exacerbation in Nintedanib group) + (1//number with at least one exacerbation in placebo) \] \]|Negative binomial model|Default log link function and adjusted for an off-set variable (logarithm of the follow-up time), for gender, height, age and region as fixed effects.|Risk ratio lower than 1 favours the treatment group over placebo.|||0.70|0.03|0.0150
70900447|NCT00514683|141289143|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9||||0.8282|TWO_SIDED|95.0|0.347|2.336|||Negative binomial model||Risk ratio is actually Rate Ratio. Rate ratio is calculated based on Negative binomial model with default log link function and adjusted for an off-set variable and age, height, gender, region (all effects fixed).|||2.336|0.347|0.8282
70900448|NCT00514683|141289143|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.73||||0.5326|TWO_SIDED|95.0|0.278|1.938|||Negative Binomial model||Risk ratio is actually Rate Ratio. Rate ratio is calculated based on Negative binomial model with default log link function and adjusted for an off-set variable and age, height, gender, region (all effects fixed).|||1.938|0.278|0.5326
70900449|NCT00514683|141289143|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49||||0.1944|TWO_SIDED|95.0|0.167|1.438|||Negative Binomial model||Risk ratio is actually Rate Ratio. Rate ratio is calculated based on Negative binomial model with default log link function and adjusted for an off-set variable and age, height, gender, region (all effects fixed).|||1.438|0.167|0.1944
70900450|NCT00514683|141289143|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.22||||0.0324|TWO_SIDED|95.0|0.056|0.882|||Negative Binomial model||Risk ratio is actually Rate Ratio. Rate ratio is calculated based on Negative binomial model with default log link function and adjusted for an off-set variable and age, height, gender, region (all effects fixed).|||0.882|0.056|0.0324
70900451|NCT00514683|141289144|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.758||||0.5206|TWO_SIDED|95.0|0.326|1.765|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.765|0.326|0.5206
70900452|NCT00514683|141289144|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.841||||0.6862|TWO_SIDED|95.0|0.362|1.952|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.952|0.362|0.6862
70900453|NCT00514683|141289144|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.517||||0.1891|TWO_SIDED|95.0|0.193|1.384|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.384|0.193|0.1891
70900454|NCT00514683|141289144|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.158||||0.0161|TWO_SIDED|95.0|0.035|0.711|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||0.711|0.035|0.0161
70900455|NCT00514683|141289145|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.173||||0.7449|TWO_SIDED|95.0|0.448|3.072|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||3.072|0.448|0.7449
70900456|NCT00514683|141289145|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.316||||0.0925|TWO_SIDED|95.0|0.083|1.209|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.209|0.083|0.0925
70900457|NCT00514683|141289145|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.19||||0.0379|TWO_SIDED|95.0|0.04|0.911|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||0.911|0.040|0.0379
70900458|NCT00514683|141289145|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.225||||0.06|TWO_SIDED|95.0|0.048|1.065|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.065|0.048|0.0600
70900459|NCT00514683|141289146|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.055||||0.7883|TWO_SIDED|95.0|0.713|1.563|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.563|0.713|0.7883
70900460|NCT00514683|141289146|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.958||||0.8293|TWO_SIDED|95.0|0.646|1.419|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.419|0.646|0.8293
70900461|NCT00514683|141289146|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.805||||0.303|TWO_SIDED|95.0|0.534|1.216|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.216|0.534|0.3030
70900462|NCT00514683|141289146|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.6505|TWO_SIDED|95.0|0.605|1.369|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.369|0.605|0.6505
70900463|NCT02736825|141289148|NON_INFERIORITY|Non-inferiority margin of 15% between two independent percentages using the z-test with unpooled variance||||||0.367|||||||Z-test|||||||0.3670
70900464|NCT02943941|141289166|OTHER|||||||0.429|||||||ANOVA|||||||0.429
70900465|NCT02943941|141289167|OTHER|||||||0.059||||||Pressure during coughing versus normal breathing initially measured at baseline.|ANOVA|||||||0.059
70900466|NCT02943941|141289168|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
70900467|NCT01564368|141289170|SUPERIORITY||area under the curve (AUC)|0.53||||0.484|ONE_SIDED|95.0||0.61||Bonferroni's correction was used for multiple comparisons adjustment, where p\<0.003 (0.05/15) was considered statistically significant.|Z-test|The empirical AUC was tested by using variance derived from the method of DeLong|Receiver operating characteristic curve and AUC were estimated empirically, and its 95% CI was constructed using variance derived from DeLong's method|Receiver Operating Characteristic curves and the corresponding Area Under the Curve (AUC), were estimated for the change in Apparent Diffusion Coefficients (ADC1 - ADC0)/ADC0 (Test: %change in ADC; Reference: pCR) detect a difference of 0.15 between the AUC under H0: AUC=0.5 and an AUC under the alternative hypothesis of 0.65. It was assumed that the number of pCR non-responders would be approximately 2.7 times greater than the number of complete responders||0.61||0.484
70900468|NCT01564368|141289170|SUPERIORITY||area under the curve|0.6||||0.017|ONE_SIDED|95.0||0.68||Bonferroni's correction was used for multiple comparisons adjustment, where p\<0.003 (0.05/15) was considered statistically significant.|Z-test|The empirical AUC was tested by using variance derived from the method of DeLong|Receiver operating characteristic curve and AUC were estimated empirically, and its 95% CI was constructed using variance derived from DeLong's method|Receiver Operating Characteristic curves and the corresponding Area Under the Curve (AUC), were estimated for the change in Apparent Diffusion Coefficients (ADC2 - ADC0)/ADC0 (Test: %change in ADC; Reference: pCR) detect a difference of 0.15 between the AUC under H0: AUC=0.5 and an AUC under the alternative hypothesis of 0.65. It was assumed that the number of pCR non-responders would be approximately 2.7 times greater than the number of complete responders||0.68||0.017
70900469|NCT01564368|141289170|SUPERIORITY||area under the curve|0.61||||0.013|ONE_SIDED|95.0||0.69||Bonferroni's correction was used for multiple comparisons adjustment, where p\<0.003 (0.05/15) is considered statistically significant.|Z-test|The empirical AUC was tested by using variance derived from the method of DeLong|Receiver operating characteristic curve and AUC were estimated empirically, and its 95% CI was constructed using variance derived from DeLong's method|Receiver Operating Characteristic curves and the corresponding Area Under the Curve (AUC), were estimated for the change in Apparent Diffusion Coefficients (ADC3 - ADC0)/ADC0 (Test: %change in ADC; Reference: pCR) detect a difference of 0.15 between the AUC under H0: AUC=0.5 and an AUC under the alternative hypothesis of 0.65. It was assumed that the number of pCR non-responders would be approximately 2.7 times greater than the number of complete responders||0.69||0.013
70963635|NCT02273726|141432204|NON_INFERIORITY|The non-inferiority was established when the 2-sided 95% CI for the difference of LS means between the 2 treatment groups using the MMRM model lay entirely above -0.75 g/dL.|LS Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.072|<|0.0001|TWO_SIDED|95.0|0.404|0.687|||Mixed Models Analysis|||Treatment comparison was made using a mixed model of repeated measures (MMRM) with baseline Hb as a covariate, and treatment, visit, visit-by-treatment interaction, ESA dependent incident dialysis within ≤4 months vs. \>4 months of starting dialysis when randomized, and randomization stratification factors except mean qualifying screening Hb (≤10.5 vs. \>10.5 g/dL) as fixed effects.||0.687|0.404|<0.0001
70900470|NCT01564368|141289171|SUPERIORITY||area under the curve|0.68|||<|0.001|ONE_SIDED|95.0||0.75||Bonferroni's correction was used for multiple comparisons adjustment, where p\<0.003 (0.05/15) was considered statistically significant.|Z-test|The empirical AUC was tested by using variance derived from the method of DeLong|Receiver operating characteristic curve and AUC were estimated empirically, and its 95% CI was constructed using variance derived from DeLong's method|Receiver Operating Characteristic curves and the corresponding Area Under the Curve (AUC), were estimated for the change in functional tumor volumes (FTV1 - FTV0)/FTV0 (Test: %change in FTV; Reference: pCR) detect a difference of 0.15 between the AUC under H0: AUC=0.5 and an AUC under the alternative hypothesis of 0.65. It was assumed that the number of pCR non-responders would be approximately 2.7 times greater than the number of complete responders||0.75||<0.001
70900471|NCT01564368|141289171|SUPERIORITY||area under the curve|0.63|||<|0.001|ONE_SIDED|95.0||0.71||Bonferroni's correction was used for multiple comparisons adjustment, where p\<0.003 (0.05/15) was considered statistically significant.|Z-test|The empirical AUC was tested by using variance derived from the method of DeLong|Receiver operating characteristic curve and AUC were estimated empirically, and its 95% CI was constructed using variance derived from DeLong's method|Receiver Operating Characteristic curves and the corresponding Area Under the Curve (AUC), were estimated for the change in functional tumor volumes (FTV2 - FTV0)/FTV0 (Test: %change in FTV; Reference: pCR) detect a difference of 0.15 between the AUC under H0: AUC=0.5 and an AUC under the alternative hypothesis of 0.65. It was assumed that the number of pCR non-responders would be approximately 2.7 times greater than the number of complete responders||0.71||<0.001
70900472|NCT01564368|141289171|SUPERIORITY||area under the curve|0.68|||<|0.001|ONE_SIDED|95.0||0.75||Bonferroni's correction was used for multiple comparisons adjustment, where p\<0.003 (0.05/15) was considered statistically significant.|Z-test|The empirical AUC was tested by using variance derived from the method of DeLong|Receiver operating characteristic curve and AUC were estimated empirically, and its 95% CI was constructed using variance derived from DeLong's method|Receiver Operating Characteristic curves and the corresponding Area Under the Curve (AUC), were estimated for the change in functional tumor volumes (FTV3 - FTV0)/FTV0 (Test: %change in FTV; Reference: pCR) detect a difference of 0.15 between the AUC under H0: AUC=0.5 and an AUC under the alternative hypothesis of 0.65. It was assumed that the number of pCR non-responders would be approximately 2.7 times greater than the number of complete responders||0.75||<0.001
70900473|NCT01564368|141289172|EQUIVALENCE|no equivalence margin was used.||||||0.032|||||||z-test|||AUC (optimized) = AUC (ΔADC)||||0.032
70900474|NCT01373931|141289189|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|0.976|||||TWO_SIDED|90.0|0.907|1.05|||Mixed Models Analysis|Ratio of Geometric LS mean is for ethinyl estradiol.||||1.05|0.907|
70900475|NCT01373931|141289189|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|0.914|||||TWO_SIDED|90.0|0.842|0.991|||Mixed Models Analysis|Ratio of Geometric LS mean is for norelgestromin.||||0.991|0.842|
70900476|NCT01373931|141289190|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.25|||||TWO_SIDED|90.0|-0.73|0.51|||Wilcoxon Signed Rank Test|Median difference is for ethinyl estradiol.||||0.51|-0.73|
70900477|NCT01373931|141289190|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|-0.5|0.5|||Wilcoxon Signed Rank Test|Median difference is for norelgestromin.||||0.50|-0.50|
70900478|NCT01373931|141289191|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|1.07||||||90.0|1.0|1.15|||Mixed Models Analysis|Ratio of Geometric LS mean is for ethinyl estradiol.||||1.15|1.00|
70900479|NCT01373931|141289191|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|1.0||||||90.0|0.944|1.07|||Mixed Models Analysis|Ratio of Geometric LS mean is for norelgestromin.||||1.07|0.944|
70900480|NCT02940574|141289209|OTHER|Linear mixed-effect analyses, exploring whether a single-dose of OT could reduce amygdala connectivity, revealed a tentative effect of 'treatment' (F(1,36)=2.00; p=.08 (one-sided))|||||<|0.08||||||Linear mixed-effect analyses, exploring whether a single-dose of OT could reduce amygdala connectivity, revealed a tentative effect of 'treatment' (F(1,36)=2.00; p=.08 (one-sided))|Mixed Models Analysis|(F(1,36)=2.00; p=.08 (one-sided))||||||<0.08
70900481|NCT00520975|141289259|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.24|TWO_SIDED|95.0|0.43|1.23|||Regression, Cox|||||1.23|0.43|0.24
70900482|NCT00520975|141289260|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.09||||0.75|TWO_SIDED|95.0|0.61|1.97|||Regression, Cox|||||1.97|0.61|0.75
70900483|NCT04810221|141289270|OTHER|Paired T-test 0|Mean Difference (Final Values)|0.18||||0.31|TWO_SIDED|95.0|-0.17|0.54|||Paired T-test 0||||Additional statistical analysis were: Bland Altman plot and linear regression analysis.|0.54|-0.17|0.31
70900484|NCT04810221|141289271|OTHER|Paired T test 0|Mean Difference (Final Values)|0.25||||0.32|TWO_SIDED|95.0|-0.24|0.75|||Paired T test 0||||Additional statistical analysis were: Bland Altman plot and linear regression analysis.|0.75|-0.24|0.32
70900485|NCT00105235|141289284|SUPERIORITY_OR_OTHER||Proportion|0.22|||||TWO_SIDED|95.0|0.086|0.423|||Exact Binomial Confidence Interval|||||.423|.086|
70900486|NCT00105235|141289285|SUPERIORITY_OR_OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|0.3|||Exact Binomial Confidence Interval|||||0.3|0|
70900487|NCT00105235|141289287|SUPERIORITY_OR_OTHER||Proportion|0.2|||||TWO_SIDED|95.0|0.04|0.3|||Exact Binomial Confidence Interval|||||0.3|0.04|
70900488|NCT00105235|141289288|SUPERIORITY_OR_OTHER||Proportion|0.1|||||TWO_SIDED|95.0|0.01|0.2|||Exact Binomial Confidence Interval|||||0.2|0.01|
70900489|NCT00261495|141289295|NON_INFERIORITY_OR_EQUIVALENCE|Tested using 95% confidence interval approach. The non-inferiority margin was 1.|Mean Difference (Net)|0.29||||0.011||95.0|-0.27|0.84||Statistical significance level was 0.05. Two-sided 95% CI of the treatment difference based on LS means \& error terms obtained from ANCOVA (covariate: baseline; factors: country, previous pain treatment, underlying disease, and treatment).|ANCOVA|If the right side of CI\<1 then the null hypothesis was rejected in favour of the alternative, and non-inferiority of OROS hydromorphone was concluded.|LS mean difference has been presented, which was calculated as hydromorphone minus oxycodone.|"Null hypothesis: Difference in change from baseline with OROS hydromorphone compared with SR oxycodone was less than or equal to 1.~Alternative hypothesis: Difference in change from baseline with OROS hydromorphone compared with SR oxycodone was greater than 1.~Sample size needed to detect a clinically significant difference of 1 was 151 per treatment arm (standard deviation = 2.4, significance level 0.025 one-sided, based on 90% power)."||0.84|-0.27|0.011
70900490|NCT00261495|141289296|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.706||95.0|-0.32|0.47||A two-sided significance level of 0.05 was used. A closed hierarchical testing procedure was used to control the overall Type I error. Procedure was stopped here, subsequent tests were exploratory in nature.|ANCOVA|Superiority of OROS hydromorphone compared to SR oxycodone was evaluated.|Mean difference calculated: hydromorphone minus oxycodone|"Null hypothesis: Difference in change from baseline between hydromorphone and oxycodone was equal to zero.~Alternative hypothesis: Difference in change from baseline between hydromorphone and oxycodone was not equal to zero."||0.47|-0.32|0.706
70900491|NCT00261495|141289297|NON_INFERIORITY_OR_EQUIVALENCE|Tested using 95% confidence interval approach. The non-inferiority margin was 1.|Mean Difference (Net)|-0.12|||<|0.001||95.0|-0.53|0.29||Statistical significance level was 0.05. Two-sided 95% CI of the treatment difference based on LS means \& error terms obtained from ANCOVA (covariate: baseline; factors: country, previous pain treatment, underlying disease, and treatment).|ANCOVA|If the right side of CI\<1 then the null hypothesis was rejected in favour of the alternative, and non-inferiority of OROS hydromorphone was concluded.|Mean difference calculated: hydromorphone minus oxycodone|"Null hypothesis: Difference in change from baseline with OROS hydromorphone compared with SR oxycodone was less than or equal to 1.~Alternative hypothesis: Difference in change from baseline with OROS hydromorphone compared with SR oxycodone was greater than 1.~Sample size needed to detect a clinically significant difference of 1 was 151 per treatment arm (standard deviation = 2.4, significance level 0.025 one-sided, based on 90% power)."||0.29|-0.53|<0.001
70900492|NCT00261495|141289298|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.87||||0.065||95.0|-5.94|0.19||A two-sided significance level of 0.05 was used. A closed hierarchical testing procedure was used to control the overall Type I error. Procedure has been stopped, test is exploratory in nature.|ANCOVA|Superiority of OROS hydromorphone compared to SR oxycodone was evaluated.|Mean difference calculated: hydromorphone minus oxycodone|"Null hypothesis: Difference in change from baseline between hydromorphone and oxycodone was equal to zero.~Alternative hypothesis: Difference in change from baseline between hydromorphone and oxycodone was not equal to zero."||0.19|-5.94|0.065
70900493|NCT00261495|141289299|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.348||95.0|-0.62|0.22||A two-sided significance level of 0.05 was used. A closed hierarchical testing approach was used to control the overall Type I error. Procedure has been stopped, test is exploratory in nature.|ANCOVA|Superiority of OROS hydromorphone compared to SR oxycodone was evaluated.|Mean difference was calculated: hydromorphone minus oxycodone|"Null hypothesis: Difference in change from baseline between hydromorphone and oxycodone was equal to zero.~Alternative hypothesis: Difference in change from baseline between hydromorphone and oxycodone was not equal to zero."||0.22|-0.62|0.348
70900494|NCT00261495|141289300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.616||95.0|-0.54|0.32||A two-sided significance level of 0.05 was used. A closed hierarchical testing approach was used to control the overall Type I error. Procedure has been stopped, test is exploratory in nature.|ANCOVA|Superiority of OROS hydromorphone compared to SR oxycodone was evaluated.|Mean difference was calculated: hydromorphone minus oxycodone|"Null hypothesis: Difference in change from baseline between hydromorphone and oxycodone was equal to zero.~Alternative hypothesis: Difference in change from baseline between hydromorphone and oxycodone was not equal to zero."||0.32|-0.54|0.616
70900495|NCT00261495|141289301|SUPERIORITY_OR_OTHER|||||||0.249||||||A two-sided significance level of 0.05 was used. A closed hierarchical testing approach was used to control the overall Type I error. Hierarchical testing procedure has been stopped, test is exploratory in nature.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Chi-squared statistic stratified for country was used.||"Null hypothesis: There is no association between study medication and dose escalation.~Alternative hypothesis: There is an association between study medication and dose escalation."||||0.249
70900496|NCT00261495|141289302|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.42||||0.05||95.0|0.0|0.84||0.05 two-sided testing, exploratory comparison|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.84|-0.00|0.050
70900497|NCT00261495|141289303|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.105||95.0|-0.06|0.67||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.67|-0.06|0.105
70900498|NCT00261495|141289304|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.058||95.0|-0.01|0.79||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.79|-0.01|0.058
70900499|NCT00261495|141289305|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23||||0.21||95.0|-0.13|0.59||0.05 two-sided test|ANCOVA||Mean difference calculated: hdromorphone minus oxycodone|Exploratory comparison||0.59|-0.13|0.210
70900500|NCT00261495|141289306|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.941||95.0|-4.87|4.52||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||4.52|-4.87|0.941
70900501|NCT00261495|141289307|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.31||||0.073||95.0|-0.03|0.65||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.65|-0.03|0.073
70900502|NCT00261495|141289308|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.431||95.0|-0.52|0.22||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.22|-0.52|0.431
70900503|NCT00261495|141289309|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.835||95.0|-0.4|0.33||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.33|-0.40|0.835
70900504|NCT00261495|141289310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51||||0.837||95.0|-5.36|4.35||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||4.35|-5.36|0.837
70900505|NCT00261495|141289311|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.832||95.0|-0.38|0.31||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.31|-0.38|0.832
70900506|NCT00261495|141289312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.143||95.0|-0.1|0.71||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.71|-0.10|0.143
70900507|NCT00261495|141289313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21||||0.345||95.0|-0.23|0.64||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.64|-0.23|0.345
70900508|NCT00261495|141289314|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.14||||0.552||95.0|-0.33|0.61||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.61|-0.33|0.552
70900509|NCT00261495|141289315|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.47||||0.042||95.0|0.02|0.93||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.93|0.02|0.042
70900510|NCT00261495|141289316|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33||||0.171||95.0|-0.14|0.81||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.81|-0.14|0.171
70900511|NCT00261495|141289317|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.475||95.0|-0.31|0.65||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.65|-0.31|0.475
70900512|NCT00261495|141289318|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23||||0.359||95.0|-0.26|0.72||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.72|-0.26|0.359
70900513|NCT00261495|141289319|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.611||95.0|-0.52|0.3||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.30|-0.52|0.611
70900514|NCT00261495|141289320|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.526||95.0|-0.6|0.31||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.31|-0.60|0.526
70900515|NCT00261495|141289321|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.769||95.0|-0.49|0.36||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.36|-0.49|0.769
70900516|NCT00261495|141289322|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.843||95.0|-0.4|0.49||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.49|-0.40|0.843
70900517|NCT00261495|141289323|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.977||95.0|-0.45|0.44||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.44|-0.45|0.977
70900518|NCT00261495|141289324|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.977||95.0|-0.47|0.49||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.49|-0.47|0.977
70900519|NCT00261495|141289325|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.902||95.0|-0.51|0.45||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.45|-0.51|0.902
70900520|NCT00261495|141289327|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.36||||0.169||95.0|-5.74|1.02||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||1.02|-5.74|0.169
70900521|NCT00261495|141289328|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.89||||0.245||95.0|-5.09|1.31||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||1.31|-5.09|0.245
70900522|NCT00261495|141289329|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.64||||0.071||95.0|-5.51|0.23||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.23|-5.51|0.071
70900523|NCT00261495|141289330|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.03||||0.297||95.0|-5.85|1.8||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||1.80|-5.85|0.297
70900524|NCT00261495|141289331|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.41||||0.205||95.0|-1.32|6.14||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||6.14|-1.32|0.205
70900525|NCT00261495|141289332|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.35||||0.107||95.0|-7.43|0.73||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.73|-7.43|0.107
70900526|NCT00261495|141289333|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.6||||0.475||95.0|-2.8|6.0||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||6.00|-2.80|0.475
70900527|NCT00261495|141289334|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.16||||0.02||95.0|-7.67|-0.65||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||-0.65|-7.67|0.020
70900528|NCT00261495|141289335|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.88||95.0|-0.3|0.26||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.26|-0.30|0.880
70900529|NCT00261495|141289336|SUPERIORITY_OR_OTHER|||||||0.32|||||||Cochran-Mantel-Haenszel|||Exploratory comparison||||0.320
70900530|NCT00261495|141289341|SUPERIORITY_OR_OTHER|||||||0.575|||||||Cochran-Mantel-Haenszel|||Exploratory comparison||||0.575
70900531|NCT00261495|141289342|SUPERIORITY_OR_OTHER|||||||0.807|||||||Cochran-Mantel-Haenszel|||Exploratory comparison||||0.807
70900532|NCT00261495|141289343|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.61||||0.118||95.0|-5.88|0.67|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.67|-5.88|0.118
70900533|NCT00261495|141289344|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.956||95.0|-3.08|2.91|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||2.91|-3.08|0.956
70900534|NCT00261495|141289345|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.299||95.0|-0.08|0.26|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.26|-0.08|0.299
70900535|NCT00261495|141289346|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.13||||0.471||95.0|-4.2|1.95|||ANCOVA||Mean difference calculated: hydromorphone minus oxymorphone|Exploratory comparison||1.95|-4.20|0.471
70900536|NCT00261495|141289347|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.84||||0.025||95.0|0.48|7.19|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||7.19|0.48|0.025
70900537|NCT00261495|141289348|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.4||||0.556||95.0|-5.61|10.42|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||10.42|-5.61|0.556
70900538|NCT00261495|141289349|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.12||||0.551||95.0|-9.11|4.88|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||4.88|-9.11|0.551
70900539|NCT00261495|141289350|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.98||||0.207||95.0|-7.63|1.66|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||1.66|-7.63|0.207
70900540|NCT00261495|141289351|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.46||||0.123||95.0|-5.6|0.68|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.68|-5.60|0.123
70900541|NCT00261495|141289352|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.602||95.0|-4.27|2.48|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||2.48|-4.27|0.602
70900542|NCT00261495|141289353|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.65||||0.647||95.0|-2.14|3.44|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||3.44|-2.14|0.647
70900543|NCT00261495|141289354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.627||95.0|-0.17|0.1|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.10|-0.17|0.627
70900544|NCT00261495|141289355|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.414||95.0|-4.45|1.84|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||1.84|-4.45|0.414
70900545|NCT00261495|141289356|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.05||||0.01||95.0|0.94|7.16|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||7.16|0.94|0.010
70900546|NCT00261495|141289357|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21||||0.955||95.0|-7.2|7.62|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||7.62|-7.20|0.955
70900547|NCT00261495|141289358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.31||||0.669||95.0|-4.72|7.34|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||7.34|-4.72|0.669
70900548|NCT00261495|141289359|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.17||||0.595||95.0|-3.15|5.49|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||5.49|-3.15|0.595
70900549|NCT00261495|141289360|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.94||||0.543||95.0|-3.98|2.1|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||2.10|-3.98|0.543
70900550|NCT05383417|141289374|SUPERIORITY|||||||0.03|||||||t-test, 1 sided|||||||0.03
70900551|NCT05383417|141289375|SUPERIORITY|||||||0.18|||||||t-test, 1 sided|||||||0.18
70900552|NCT05383417|141289376|SUPERIORITY|||||||0.007|||||||t-test, 1 sided|Day 2||||||0.007
70900553|NCT05383417|141289376|SUPERIORITY|||||||0.04|||||||t-test, 1 sided|Day 7||||||0.04
70900554|NCT05383417|141289377|SUPERIORITY|||||||0.03|||||||t-test, 1 sided|Day 1||||||0.03
70900555|NCT05383417|141289377|SUPERIORITY|||||||0.04|||||||t-test, 1 sided|Day 7||||||0.04
70900556|NCT05383417|141289378|SUPERIORITY|||||||0.04|||||||t-test, 1 sided|Day 1||||||0.04
70900557|NCT05383417|141289379|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|Day2||||||0.02
70900558|NCT05383417|141289380|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
70900559|NCT05383417|141289381|SUPERIORITY|||||||0.007|||||||Chi-squared|||||||0.007
70900560|NCT05383417|141289382|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
70900561|NCT05383417|141289383|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
70900562|NCT05383417|141289384|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
70900563|NCT05383417|141289385|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
70900564|NCT01932697|141289400|SUPERIORITY|||||||0.01|||||||Paired t-test|||||||.01
70900565|NCT01932697|141289401|SUPERIORITY||||||<|0.001|||||||Paired t-test|||||||<0.001
70900566|NCT01932697|141289402|SUPERIORITY||||||<|0.001|||||||Paired t-test|||||||<0.001
70900567|NCT01932697|141289403|SUPERIORITY||||||<|0.001|||||||Paired t-test|||||||<0.001
70900568|NCT03525548|141289423|SUPERIORITY||Least squares (LS) mean difference|10.0|||<|0.0001|TWO_SIDED|95.0|7.4|12.6|||Mixed-effects model for repeated measure|||||12.6|7.4|<0.0001
70900569|NCT03525548|141289424|SUPERIORITY||LS mean difference|-45.1|||<|0.0001|TWO_SIDED|95.0|-50.1|-40.1|||Mixed-effects model for repeated measure|||||-40.1|-50.1|<0.0001
70900570|NCT03525548|141289425|SUPERIORITY||LS mean difference|17.4|||<|0.0001|TWO_SIDED|95.0|11.8|23.0|||Mixed-effects model for repeated measure|||||23.0|11.8|<0.0001
70900571|NCT00643123|141289433|OTHER||Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|2.3||0.45|TWO_SIDED||||||t-test, 2 sided|||||||.45
70900572|NCT02623855|141289445|SUPERIORITY|Our hypothesis was that park prescriptions with group visits would have a superior result than park prescriptions alone.||||||0.6099|||||||t-test, 2 sided|||The study is powered for our primary outcome, caregiver stress as measured by the 10-item perceived stress s score (PSS10). Normative data from population samples show a mean PSS10 score of 13.2 points with a standard deviation of 6.35 points and a within-subject correlation coefficient of 0.77 over 2 weeks.We powered the study to detect a three point difference in the change of the PSS10. This effect size is consistent with other estimates of a clinically significant change.||||0.6099
70900573|NCT02623855|141289447|SUPERIORITY|||||||0.0085|||||||t-test, 2 sided|||||||0.0085
70900574|NCT02623855|141289449|SUPERIORITY|||||||0.1749|||||||t-test, 2 sided|||||||0.1749
70900575|NCT01059630|141289454|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.4|0.7|||Log Rank|||||0.70|0.40|<0.0001
70900576|NCT01059630|141289456|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.45|0.73|||Log Rank|||||0.73|0.45|<0.0001
70900577|NCT01059630|141289457|SUPERIORITY_OR_OTHER_LEGACY||Difference in response rate|0.98||||0.9298|TWO_SIDED|95.0|0.58|1.65|||Cochran-Mantel-Haenszel|||||1.65|0.58|0.9298
70900578|NCT01059630|141289458|SUPERIORITY_OR_OTHER_LEGACY||Difference in response rate|-0.9||||0.7857|TWO_SIDED|95.0|-8.44|6.64|||Cochran-Mantel-Haenszel|||||6.64|-8.44|0.7857
70900579|NCT01059630|141289463|SUPERIORITY_OR_OTHER_LEGACY||Difference in response rate|2.24||||0.8347|TWO_SIDED|95.0|-7.2|11.69|||Cochran-Mantel-Haenszel|||||11.69|-7.20|0.8347
70900580|NCT01059630|141289464|SUPERIORITY_OR_OTHER_LEGACY||Difference in response rate|8.55||||0.0466|TWO_SIDED|95.0|-0.22|17.32|||Cochran-Mantel-Haenszel|||||17.32|-0.22|0.0466
70900581|NCT01059630|141289465|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.43|||||TWO_SIDED|95.0|0.31|0.61||||||||0.61|0.31|
70900582|NCT01059630|141289466|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.39|0.67||||||||0.67|0.39|
70900583|NCT01059630|141289467|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.13|||||TWO_SIDED|95.0|0.04|0.45||||||||0.45|0.04|
70900584|NCT01059630|141289468|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.48|||||TWO_SIDED|95.0|0.29|0.81||||||||0.81|0.29|
70900585|NCT01059630|141289469|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57||||0.0001|TWO_SIDED|95.0|0.44|0.74|||Log Rank|||||0.74|0.44|0.0001
70900586|NCT01059630|141289471|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.081|TWO_SIDED|95.0|0.57|1.03|||Log Rank|||||1.03|0.57|0.0810
70900587|NCT04681729|141289491|SUPERIORITY||Odds Ratio (OR)|1.03||||0.9492|TWO_SIDED|95.0|0.41|2.56||Cochran-Mantel-Haenszel test was performed on the association between the ice cube provocation test result and intervention group, stratified by region and background H1-antihistamine regular/daily use (Yes or No). Threshold of significance at 0.01.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the family-wise type-I error. Testing was then performed sequentially in order the endpoints were reported and continued when primary endpoint was statistically significant at two-sided 0.01.||2.56|0.41|0.9492
70900588|NCT04766086|141289541|OTHER||Risk difference|0.0||||||95.0|-3.8|3.7||||||||3.7|-3.8|
70900589|NCT04766086|141289542|OTHER||GMR|0.546|||||TWO_SIDED|95.0|0.405|0.736||||||GMR for Anti-PT Antibody: GMR for GBS6 + Tdap/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||0.736|0.405|
70900590|NCT04766086|141289542|OTHER||GMR|0.567|||||TWO_SIDED|95.0|0.455|0.707||||||GMR for Anti-FHA Antibody: GMR for GBS6 + Tdap/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||0.707|0.455|
70900591|NCT04766086|141289542|OTHER||GMR|0.588|||||TWO_SIDED|95.0|0.451|0.766||||||GMR for Anti-PRN Antibody: GMR for GBS6 + Tdap/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||0.766|0.451|
70900592|NCT04766086|141289543|OTHER||GMR|0.89|||||TWO_SIDED|95.0|0.38|2.089||||||GMR for serotype Ia: GMR for GBS6 + GBS6/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||2.089|0.380|
70900593|NCT04766086|141289543|OTHER||GMR|1.149|||||TWO_SIDED|95.0|0.455|2.901||||||GMR for serotype Ib: GMR for GBS6 + GBS6/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||2.901|0.455|
70900594|NCT04766086|141289543|OTHER||GMR|1.032||||||95.0|0.551|1.931||||||GMR for serotype II: GMR for GBS6 + GBS6/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||1.931|0.551|
70900595|NCT04766086|141289543|OTHER||GMR|0.635|||||TWO_SIDED|95.0|0.303|1.329||||||GMR for serotype III: GMR for GBS6 + GBS6/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||1.329|0.303|
70900596|NCT04766086|141289543|OTHER||GMR|1.474|||||TWO_SIDED|95.0|0.842|2.58||||||GMR for serotype IV: GMR for GBS6 + GBS6/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||2.580|0.842|
70900597|NCT04766086|141289543|OTHER||GMR|0.559|||||TWO_SIDED|95.0|0.232|1.349||||||GMR for serotype V: GMR for GBS6 + GBS6/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||1.349|0.232|
70900598|NCT02496767|141289556|SUPERIORITY||Least squares mean difference|1.707|STANDARD_ERROR_OF_MEAN|1.9365||0.3782|TWO_SIDED|95.0|-2.089|5.503|||Repeated-measures mixed model|||||5.503|-2.089|0.3782
70900599|NCT02496767|141289556|SUPERIORITY||Least squares mean difference|0.612|STANDARD_ERROR_OF_MEAN|2.0245||0.7625|TWO_SIDED|95.0|-3.359|4.583|||Repeated-measures mixed model|||||4.583|-3.359|0.7625
70900600|NCT02496767|141289556|SUPERIORITY||Least squares mean difference|0.428|STANDARD_ERROR_OF_MEAN|2.1081||0.8394|TWO_SIDED|95.0|-3.711|4.566|||Repeated-measures mixed model|||||4.566|-3.711|0.8394
70900601|NCT02496767|141289557|SUPERIORITY||Least squares mean difference|0.31|STANDARD_ERROR_OF_MEAN|0.41||0.4521|TWO_SIDED|95.0|-0.5|1.12|||Repeated-measures mixed model|||||1.12|-0.50|0.4521
70900602|NCT02496767|141289557|SUPERIORITY||Least squares mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.426||0.712|TWO_SIDED|95.0|-1.0|0.68|||Repeated-measures mixed model|||||0.68|-1.00|0.7120
70900603|NCT02496767|141289557|SUPERIORITY||Least squares mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.439||0.451|TWO_SIDED|95.0|-1.19|0.53|||Repeated-measures mixed model|||||0.53|-1.19|0.4510
70900604|NCT02496767|141289558|SUPERIORITY||Mean Difference (Final Values)|-0.0011||||0.9505|TWO_SIDED|95.0|-0.0374|0.0351|||Repeated-measures mixed model|||||0.0351|-0.0374|0.9505
70900605|NCT02496767|141289558|SUPERIORITY||Mean Difference (Final Values)|0.0066||||0.7336|TWO_SIDED|95.0|-0.0317|0.045|||Repeated-measures mixed model|||||0.0450|-0.0317|0.7336
70900606|NCT02496767|141289558|SUPERIORITY||Mean Difference (Final Values)|0.0088||||0.6593|TWO_SIDED|95.0|-0.0303|0.0479|||Repeated-measures mixed model|||||0.0479|-0.0303|0.6593
70900607|NCT02496767|141289559|SUPERIORITY||Hazard Ratio (HR)|0.818||||0.2369|TWO_SIDED|95.0|0.587|1.141|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.141|0.587|0.2369
70900608|NCT02496767|141289559|SUPERIORITY||Hazard Ratio (HR)|0.988||||0.942|TWO_SIDED|95.0|0.711|1.372|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.372|0.711|0.9420
70900609|NCT02496767|141289559|SUPERIORITY||Hazard Ratio (HR)|0.933||||0.6853|TWO_SIDED|95.0|0.668|1.304|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.304|0.668|0.6853
70900610|NCT02496767|141289560|SUPERIORITY||Hazard Ratio (HR)|1.066||||0.7667|TWO_SIDED|95.0|0.698|1.627|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.627|0.698|0.7667
70900611|NCT02496767|141289560|SUPERIORITY||Hazard Ratio (HR)|0.904||||0.6619|TWO_SIDED|95.0|0.577|1.419|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.419|0.577|0.6619
70900612|NCT02496767|141289560|SUPERIORITY||Hazard Ratio (HR)|0.882||||0.5856|TWO_SIDED|95.0|0.561|1.386|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.386|0.561|0.5856
70900613|NCT02496767|141289561|SUPERIORITY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|1.103||0.9991|TWO_SIDED|95.0|-2.17|2.17|||Repeated-measures mixed model|||||2.17|-2.17|0.9991
70900614|NCT02496767|141289561|SUPERIORITY||Least squares mean difference|-0.8|STANDARD_ERROR_OF_MEAN|1.138||0.4808|TWO_SIDED|95.0|-3.04|1.43|||Repeated-measures mixed model|||||1.43|-3.04|0.4808
70900615|NCT02496767|141289561|SUPERIORITY||Least squares mean difference|-0.6|STANDARD_ERROR_OF_MEAN|1.165||0.6082|TWO_SIDED|95.0|-2.89|1.69|||Repeated-measures mixed model|||||1.69|-2.89|0.6082
70900616|NCT02496767|141289562|SUPERIORITY||Hazard Ratio (HR)|0.776||||0.2602|TWO_SIDED|95.0|0.5|1.206|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.206|0.500|0.2602
70900617|NCT02496767|141289562|SUPERIORITY||Hazard Ratio (HR)|1.094||||0.6748|TWO_SIDED|95.0|0.72|1.662|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.662|0.720|0.6748
70900618|NCT02496767|141289562|SUPERIORITY||Hazard Ratio (HR)|0.938||||0.7694|TWO_SIDED|95.0|0.609|1.443|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.443|0.609|0.7694
70900619|NCT01678131|141289609|SUPERIORITY_OR_OTHER_LEGACY||Posterior Percentage Probability|100.0||||||||||||||The posterior percentage probability of the true success rate of the FNA procedure for the 3 combined treatment groups (n=29) was determined by a Bayesian calculation, using a Jeffrey's prior distribution (i.e. Beta \[0.5,0.5\]) on the true success rate. Neither P-values, nor confidence intervals are estimated in this analysis. The primary hypothesis was met if the posterior percentage probability was \> 80% that the true success rate is at least 60%.||||
70900620|NCT00685945|141289627|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||The effect of bradykinin on net t-PA release was determined using general linear model-repeated measures ANOVA in which the between-subject variable was gender, and the within-subjects variables were drug (control, +L-NMMA, +L-NMMA plus isosorbide, or +L-NMMA plus sildenafil) and dose of bradykinin.||||0.04
70900621|NCT00685945|141289628|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|Repeated measures ANOVA||||||<0.001
70900622|NCT03183388|141289630|OTHER|Mixed model with time (baseline and endpoint) as within-subjects factor; compare Least Square (LS) estimate of endpoint minus baseline to zero. The best-fitting model was chosen based on information criteria.|Endpoint minus Baseline|-3.04|STANDARD_ERROR_OF_MEAN|0.5||0.0001|TWO_SIDED|95.0|-4.14|-1.93|||t-test, 2 sided|||||-1.93|-4.14|0.0001
70900623|NCT03183388|141289631|OTHER|Mixed model with time (baseline and midpoint) as within-subjects factor; compare LS estimate of midpoint minus baseline to zero.|Midpoint minus Baseline|-1.37|STANDARD_ERROR_OF_MEAN|2.51||0.6|TWO_SIDED|95.0|-6.97|4.23|||t-test, 2 sided|||||4.23|-6.97|0.60
70900624|NCT03183388|141289632|OTHER|Mixed model with time (baseline and endpoint) as within-subjects factor; compare LS estimate of endpoint minus baseline to zero.|Endpoint minus Baseline|0.11|STANDARD_ERROR_OF_MEAN|0.016||0.0001|TWO_SIDED|95.0|0.074|0.146|||t-test, 2 sided|||||0.146|0.074|0.0001
70900625|NCT03183388|141289633|OTHER|Mixed model with time (baseline and midpoint) as within-subjects factor; compare LS estimate of midpoint minus baseline to zero.|Midpoint minus Baseline|0.031|STANDARD_ERROR_OF_MEAN|0.055||0.58|TWO_SIDED|95.0|-0.095|0.157|||t-test, 2 sided|||||0.157|-0.095|0.58
70900626|NCT00847405|141289634|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.64||||||90.0|95.93|111.97|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||111.97|95.93|
70900627|NCT00847405|141289635|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.81||||||90.0|97.95|107.91|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.91|97.95|
70900628|NCT00847405|141289636|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.25||||||90.0|98.35|108.41|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.41|98.35|
70900629|NCT00071721|141289645|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.958||||0.88||95.0|||||Cox Proportional Hazards|||||||0.88
70900630|NCT00949715|141289662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0||||0.2352|TWO_SIDED|95.0|-2.7|10.8|||t-test, 2 sided|||HO: Pacing at selective RV sites (mid-septum or apex) has no different impact on the change in LVEF after 24 months follow-up. With 12% SD and 80 subjects in groups will have 90% power to detect an absolute difference in LVEF of 6.2% at 24 months follow-up at an alpha level of 0.05.||10.8|-2.7|0.2352
70900631|NCT00949715|141289663|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1||||0.7405|TWO_SIDED|95.0|-7.6|5.5|||t-test, 2 sided|||Ho: Packing at selective RV sites (mid-Septum or apex) has no different impact on LVEF change from 2 weeks to 24 months.||5.5|-7.6|0.7405
70900632|NCT00949715|141289664|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.3||||0.1051|TWO_SIDED|95.0|-25.1|2.4|||t-test, 2 sided|||Ho: Pacing at selective sites (RVS or RVA) has no different impact on LV end systolic volume||2.4|-25.1|0.1051
70900633|NCT00949715|141289665|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.9||||0.9835||95.0||||Adjusting for age and gender|Wilcoxon (Mann-Whitney)|Rank Sum||Ho: The AT/AF burden in the RVS group is the same as the RVA group.||||0.9835
70900634|NCT03091673|141289709|OTHER||||||<|0.001||||||P-value was computed using a t-test to determine if change in plasma glucose from baseline to 30 minutes was zero.|t-test, 2 sided|||||||<0.001
70900635|NCT00605202|141289723|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value of the change in the plasma potassium (baseline to 2 weeks) between arms|t-test, 2 sided|||Statistical analysis applies to the change in the plasma potassium (baseline to 2 weeks) between arms||||0.007
70900636|NCT02276066|141289724|OTHER|We performed a delta analysis, by graphing the difference between the two measurements, we wanted to visually assess the degree of agreement or discrepancy between the two methods. We were looking to evaluate the consistency, accuracy, or bias between different measurement techniques.|||||<|0.05|||||||Delta analysis|||||||<0.05
70900637|NCT05050578|141289730|NON_INFERIORITY|Noninferiority in distance VA was declared if upper confidence limit was less than 0.05.|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.003|||ONE_SIDED|95.0||0.0||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, visit, lens by visit interaction, period, sequence) and random (subject) effects. Difference = LID18869 minus AOHG. Sign is retained with the rounded value.|||0.00||
70900638|NCT03386032|141289731|SUPERIORITY||||||<|0.05|||||||ANCOVA|Model adjusted means.||Change from baseline in variables were analyzed separately using a mixed model for repeated measures with Subject nested within treatment (random effect), and Treatment, Week, Treatment-by-Week, Age \& Baseline (fixed effects). Last Observation was Carried Forward (LOCF) for drops. Sporadic missing data were left missing.||||<0.05
70900639|NCT03386032|141289732|SUPERIORITY||||||<|0.05|||||||ANCOVA|Model adjusted means. Last Observation was Carried Forward (LOCF) for drops. Sporadic missing data were left miss||"Change from baseline in variables were analyzed separately using a mixed model for repeated measures with Subject nested within treatment (random effect), and Treatment, Week, Treatment-by-Week, Age \& Baseline (fixed effects). Last Observation was Carried Forward (LOCF) for drops. Sporadic missing data were left missing.~Significance level: 0.05 (2-sided)"||||<0.05
70900640|NCT04525547|141289745|OTHER|||||||0.817|||||||t-test, 2 sided|||||||0.8170
70900641|NCT04525547|141289746|OTHER|||||||0.6533|||||||t-test, 2 sided|||||||0.6533
70900642|NCT04425902|141289754|OTHER||Ratio of geometric least square mean|1.11|||||TWO_SIDED|90.0|0.94|1.32|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.32|0.94|
70900643|NCT04425902|141289755|OTHER||Ratio of geometric least square mean|1.12|||||TWO_SIDED|90.0|0.95|1.32|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.32|0.95|
70900644|NCT04425902|141289756|OTHER||Ratio of geometric least square mean|0.95|||||TWO_SIDED|90.0|0.83|1.08|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.08|0.83|
70900645|NCT04425902|141289759|OTHER||Ratio of geometric least square mean|1.23|||||TWO_SIDED|90.0|0.71|2.14|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||2.14|0.71|
70900646|NCT04425902|141289760|OTHER||Ratio of geometric least square mean|1.23|||||TWO_SIDED|90.0|0.71|2.14|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||2.14|0.71|
70900647|NCT04425902|141289761|OTHER||Ratio of geometric least square mean|1.11|||||TWO_SIDED|90.0|0.72|1.69|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.69|0.72|
70900648|NCT04425902|141289764|OTHER||Ratio of geometric least square mean|1.08|||||TWO_SIDED|90.0|0.97|1.2|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.20|0.97|
70900649|NCT04425902|141289765|OTHER||Ratio of geometric least square mean|1.09|||||TWO_SIDED|90.0|0.98|1.21|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.21|0.98|
70900650|NCT04425902|141289766|OTHER||Ratio of geometric least square mean|1.04|||||TWO_SIDED|90.0|0.92|1.17|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.17|0.92|
70900651|NCT04425902|141289769|OTHER||Ratio of geometric least square mean|1.02|||||TWO_SIDED|90.0|0.88|1.18|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.18|0.88|
70900652|NCT04425902|141289770|OTHER||Ratio of geometric least square mean|1.03|||||TWO_SIDED|90.0|0.89|1.19|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.19|0.89|
70900653|NCT04425902|141289771|OTHER||Ratio of geometric least square mean|1.05|||||TWO_SIDED|90.0|0.93|1.18|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.18|0.93|
70900654|NCT04425902|141289774|OTHER||Ratio of geometric least square mean|1.12|||||TWO_SIDED|90.0|0.72|1.75|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.75|0.72|
70900655|NCT04425902|141289775|OTHER||Ratio of geometric least square mean|0.97|||||TWO_SIDED|90.0|0.54|1.73|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.73|0.54|
70900656|NCT04425902|141289776|OTHER||Ratio of geometric least square mean|1.14|||||TWO_SIDED|90.0|0.73|1.78|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.78|0.73|
70900657|NCT04425902|141289779|OTHER||Ratio of geometric least square mean|0.94|||||TWO_SIDED|90.0|0.8|1.11|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.11|0.80|
70900658|NCT04425902|141289780|OTHER||Ratio of geometric least square mean|0.93|||||TWO_SIDED|90.0|0.79|1.1|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.10|0.79|
70900659|NCT04425902|141289781|OTHER||Ratio of geometric least square mean|0.9|||||TWO_SIDED|90.0|0.73|1.12|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.12|0.73|
70900660|NCT04425902|141289784|OTHER||Ratio of geometric least square mean|1.07|||||TWO_SIDED|90.0|0.94|1.22|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.22|0.94|
70900661|NCT04425902|141289785|OTHER||Ratio of geometric least square mean|1.05|||||TWO_SIDED|90.0|0.92|1.19|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.19|0.92|
70900662|NCT04425902|141289786|OTHER||Ratio of geometric least square mean|1.25|||||TWO_SIDED|90.0|0.96|1.63|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.63|0.96|
70900663|NCT04425902|141289789|OTHER||Ratio of geometric least square mean|0.73|||||TWO_SIDED|90.0|0.52|1.03|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.03|0.52|
70900664|NCT04425902|141289790|OTHER||Ratio of geometric least square mean|0.61|||||TWO_SIDED|90.0|0.45|0.82|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||0.82|0.45|
70900665|NCT04425902|141289791|OTHER||Ratio of geometric least square mean|0.78|||||TWO_SIDED|90.0|0.54|1.14|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.14|0.54|
70900666|NCT04425902|141289897|OTHER||Ratio of geometric least square mean|0.92|||||TWO_SIDED|90.0|0.49|1.71|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.71|0.49|
70900667|NCT04425902|141289898|OTHER||Ratio of geometric least square mean|0.93|||||TWO_SIDED|90.0|0.74|1.16|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.16|0.74|
70900668|NCT04425902|141289899|OTHER||Ratio of geometric least square mean|0.86|||||TWO_SIDED|90.0|0.43|1.72|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.72|0.43|
70900669|NCT04425902|141289902|OTHER||Ratio of geometric least square mean|0.99|||||TWO_SIDED|90.0|0.75|1.29|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.29|0.75|
70900670|NCT04425902|141289903|OTHER||Ratio of geometric least square mean|0.99|||||TWO_SIDED|90.0|0.75|1.29|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.29|0.75|
70900671|NCT04425902|141289904|OTHER||Ratio of geometric least square mean|0.94|||||TWO_SIDED|90.0|0.73|1.22|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.22|0.73|
70900672|NCT04425902|141289907|OTHER||Ratio of geometric least square mean|1.1|||||TWO_SIDED|90.0|0.93|1.3|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.30|0.93|
70900673|NCT04425902|141289908|OTHER||Ratio of geometric least square mean|0.99|||||TWO_SIDED|90.0|0.83|1.19|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.19|0.83|
70900674|NCT04425902|141289909|OTHER||Ratio of geometric least square mean|1.12|||||TWO_SIDED|90.0|0.88|1.44|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.44|0.88|
70900675|NCT04425902|141289912|OTHER||Ratio of geometric least square mean|0.9|||||TWO_SIDED|90.0|0.75|1.09|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.09|0.75|
70900676|NCT04425902|141289913|OTHER||Ratio of geometric least square mean|0.91|||||TWO_SIDED|90.0|0.76|1.09|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.09|0.76|
70900677|NCT04425902|141289914|OTHER||Ratio of geometric least square mean|0.85|||||TWO_SIDED|90.0|0.65|1.1|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.10|0.65|
70900678|NCT02901626|141289940|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.83|1.2||||||||1.20|0.83|
70900679|NCT02901626|141289941|SUPERIORITY||Median Difference (Net)|2.0|||||TWO_SIDED|95.0|-4.0|8.0||||||||8|-4|
70900680|NCT02901626|141289942|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-1.06|0.8||||||||0.80|-1.06|
70900681|NCT02901626|141289943|SUPERIORITY||Risk Ratio (RR)|1.26|||||TWO_SIDED|95.0|0.92|1.71||||||||1.71|0.92|
70900682|NCT02901626|141289944|SUPERIORITY||Risk Ratio (RR)|1.2|||||TWO_SIDED|95.0|0.93|1.55||||||||1.55|0.93|
70900683|NCT02901626|141289945|SUPERIORITY||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.93|1.45||||||||1.45|0.93|
70900684|NCT02901626|141289946|SUPERIORITY||Risk Ratio (RR)|1.3|||||TWO_SIDED|95.0|0.92|1.82||||||||1.82|0.92|
70900685|NCT02901626|141289947|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.79|1.19||||||||1.19|0.79|
70900686|NCT02901626|141289948|SUPERIORITY||Risk Ratio (RR)|1.21|||||TWO_SIDED|95.0|0.61|2.39||||||||2.39|0.61|
70900687|NCT02901626|141289949|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.79|1.31||||||||1.31|0.79|
70900688|NCT02901626|141289950|SUPERIORITY||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.55|2.04||||||||2.04|0.55|
70900689|NCT02901626|141289951|SUPERIORITY||Median Difference (Net)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0|0|
70900690|NCT02901626|141289952|SUPERIORITY||Risk Ratio (RR)|1.36|||||TWO_SIDED|95.0|0.95|1.94||||||||1.94|0.95|
70900691|NCT02901626|141289953|SUPERIORITY||Risk Ratio (RR)|1.45|||||TWO_SIDED|95.0|1.0|2.11||||||||2.11|1.00|
70900692|NCT02901626|141289954|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|0.88|1.18||||||||1.18|0.88|
70900693|NCT02901626|141289955|SUPERIORITY||Median Difference (Net)|0.0|||||TWO_SIDED|95.0|-12.0|12.0||||||||12|-12|
70900694|NCT02901626|141289956|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.69|1.17||||||||1.17|0.69|
70900695|NCT02901626|141289957|SUPERIORITY||Median Difference (Net)|1.0|||||TWO_SIDED|95.0|-12.0|14.0||||||||14|-12|
70900696|NCT02901626|141289958|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.06|15.7||||||||15.7|0.06|
70900697|NCT02901626|141289959|SUPERIORITY||Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.25|2.65||||||||2.65|0.25|
70900698|NCT02901626|141289960|SUPERIORITY||Risk Ratio (RR)|0.56|||||TWO_SIDED|95.0|0.17|1.9||||||||1.90|0.17|
70900699|NCT02901626|141289961|SUPERIORITY||Risk Ratio (RR)|1.15|||||TWO_SIDED|95.0|0.68|1.96||||||||1.96|0.68|
70900700|NCT02901626|141289962|SUPERIORITY||Risk Ratio (RR)|0.95|||||TWO_SIDED|95.0|0.71|1.27||||||||1.27|0.71|
70900701|NCT02901626|141289963|SUPERIORITY||Risk Ratio (RR)|0.72|||||TWO_SIDED|95.0|0.37|1.41||||||||1.41|0.37|
70900702|NCT02901626|141289964|SUPERIORITY||Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.39|3.37||||||||3.37|0.39|
70900703|NCT02901626|141289965|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.78|1.29||||||||1.29|0.78|
70900704|NCT02901626|141289966|SUPERIORITY||Risk Ratio (RR)|0.8|||||TWO_SIDED|95.0|0.58|1.1||||||||1.10|0.58|
70900705|NCT02901626|141289967|SUPERIORITY||Risk Ratio (RR)|2.45|||||TWO_SIDED|95.0|0.48|12.57||||||||12.57|0.48|
70900706|NCT02901626|141289968|SUPERIORITY||Risk Ratio (RR)|0.65|||||TWO_SIDED|95.0|0.27|1.58||||||||1.58|0.27|
70900707|NCT02901626|141289969|SUPERIORITY||Risk Ratio (RR)|0.67|||||TWO_SIDED|95.0|0.47|0.97||||||||0.97|0.47|
70900708|NCT02901626|141289970|SUPERIORITY||Risk Ratio (RR)|0.49|||||TWO_SIDED|95.0|0.09|2.66||||||||2.66|0.09|
70900709|NCT02901626|141289971|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.81|1.37||||||||1.37|0.81|
70900710|NCT02901626|141289972|SUPERIORITY||Median Difference (Net)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0|0|
70900711|NCT02901626|141289973|SUPERIORITY||Median Difference (Net)|10.0|||||TWO_SIDED|95.0|-16.0|36.0||||||||36|-16|
70900712|NCT00331344|141289976|OTHER||Dose Level VIa|1.0|||||TWO_SIDED||||||||Dose level VIa (mitoxantrone hydrochloride 12 mg/m2 IV over 30 minutes, ixabepilone 30mg/m2 IV over 3 hours on day 1, pegfilgrastim 6mg SC on day 2, oral prednisone twice daily on days 1-21) was determined to be MTD, based on 1 event of DLT at VIa.|Cohorts of 3 patients will be enrolled at each dose level; if 1 dose limiting toxicity (DLT) is observed then the cohort will be expanded to 6 patients. If a second DLT is observed, the previous dose level will be considered the MTD. If all observed DLT are due to neuropathy (specific to ixabepilone), then we would consider the previous dose level of Ixabepilone the MTD for that drug, and escalate mitoxantrone hydrochloride as described above to a maximum dose of 12 mg/m\^2.||||
70900713|NCT05674890|141289978|EQUIVALENCE|"Any deviation greater that +/- 0.60 (Effect size/Stdev OR 0.15/0.25=0.60) between device means was considered non-equivalent."|Mean Difference (Net)|-0.29|STANDARD_DEVIATION|2.49||0.297|TWO_SIDED||||||t-test, 2 sided|||Prior to patient enrollment, a power calculation was conducted to assess the ability of our analyses to reliably detect differences between the HFA and SSVR. With a sample size of 80, assumed effect size of 0.15, standard deviation of 0.25, intraclass correlation coefficient of 0.50, and significance level of 0.05, our analysis reaches a power of 0.87.||||0.297
70900714|NCT05674890|141289979|EQUIVALENCE|"Any deviation greater that +/- 0.60 (Effect size/Stdev OR 0.15/0.25=0.60) between device means was considered non-equivalent."|Mean Difference (Net)|-2.11|STANDARD_DEVIATION|2.81|<|0.001|TWO_SIDED||||||t-test, 2 sided|||Prior to patient enrollment, a power calculation was conducted to assess the ability of our analyses to reliably detect differences between the HFA and SSVR. With a sample size of 80, assumed effect size of 0.15, standard deviation of 0.25, intraclass correlation coefficient of 0.50, and significance level of 0.05, our analysis reaches a power of 0.87.||||<0.001
70900715|NCT05674890|141289980|EQUIVALENCE|"Any deviation greater that +/- 0.60 (Effect size/Stdev OR 0.15/0.25=0.60) between device means was considered non-equivalent."|Mean Difference (Net)|-48.75|STANDARD_DEVIATION|56.48|<|0.001|TWO_SIDED||||||t-test, 2 sided|||Prior to patient enrollment, a power calculation was conducted to assess the ability of our analyses to reliably detect differences between the HFA and SSVR. With a sample size of 80, assumed effect size of 0.15, standard deviation of 0.25, intraclass correlation coefficient of 0.50, and significance level of 0.05, our analysis reaches a power of 0.87.||||<0.001
70900716|NCT02228967|141289988|OTHER||||||=|0.274||||||A priori threshold for statistical significance was 0.05|Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||=0.274
70900717|NCT02228967|141289989|OTHER||||||=|0.083|||||||Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||=0.083
70900718|NCT02228967|141289990|OTHER||||||=|0.028|||||||Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||=0.028
70900719|NCT02228967|141289991|OTHER||||||=|0.708|||||||Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||=0.708
70900720|NCT02228967|141289992|OTHER||||||=|0.197||||||A priori threshold for statistical significance was 0.05.|Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tets (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||=0.197
70900721|NCT02228967|141289993|OTHER||||||=|0.023||||||A priori threshold for statistical significance was 0.05.|Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||=0.023
70900722|NCT02228967|141289994|OTHER||||||<|0.001||||||A priori threshold for statistical significance was 0.05.|Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||<0.001
70900723|NCT02228967|141289995|OTHER||||||=|0.348||||||A priori threshold for statistical significance was 0.05.|Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.||||=0.348
70900724|NCT02228967|141289996|OTHER||Mean Difference (Final Values)|0.345|STANDARD_ERROR_OF_MEAN|0.203||0.091|TWO_SIDED|||||A priori threshold for statistical significance was 0.05.|Repeated Measures GLM|||Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.||||0.091
70900725|NCT02228967|141289997|OTHER||Mean Difference (Net)|0.393|STANDARD_ERROR_OF_MEAN|0.362||0.278|TWO_SIDED|||||A priori alpha set at 0.05|Repeated Measures GLM|||Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.||||.278
70900726|NCT02228967|141289998|OTHER||Mean Difference (Net)|3.163|STANDARD_ERROR_OF_MEAN|1.44||0.029|TWO_SIDED|||||A priori alpha set at 0.05.|Repeated Measures GLM|||Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.||||0.029
70900727|NCT02228967|141289999|OTHER||Mean Difference (Net)|-0.015||||0.897|TWO_SIDED|||||A priori alpha set at 0.05.|Repeated Measures GLM|||Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.||||0.897
70900728|NCT02228967|141290000|OTHER|||||||0.15|||||||Linear mixed effects|||Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.||||0.15
70900729|NCT02228967|141290001|OTHER|||||||0.2||||||A priori alpha set at 0.05.|Linear mixed effects|||Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.||||0.20
70900730|NCT02228967|141290002|OTHER|||||||0.38||||||A priori alpha set at 0.05.|Linear mixed effects|||Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.||||0.38
70900731|NCT02228967|141290003|OTHER|A priori alpha set at 0.05||||||0.48|||||||Linear mixed effects|||Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.||||0.48
70900732|NCT02228967|141290004|OTHER|A priori alpha set at 0.05.||||||0.09|||||||Linear mixed effects|||Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.||||0.09
70900733|NCT02228967|141290005|OTHER|||||||0.08|||||||Linear mixed effects|||A priori alpha set at 0.05||||0.08
70900734|NCT02228967|141290006|OTHER|||||||0.11|||||||Linear mixed effects|||A priori alpha set at 0.05||||0.11
70900735|NCT02228967|141290007|OTHER|||||||0.84|||||||Linear mixed effects|||A priori alpha set at 0.05||||0.84
70900736|NCT03815019|141290020|SUPERIORITY||Odds Ratio, log|7.2218|STANDARD_ERROR_OF_MEAN|13083.0|||TWO_SIDED||||||||Participants in the megestrol group who successfully transitioned to oral feeding.|Analysis conducted using Generalized Linear Mixed Models with a logit link within SAS Proc GLIMMIX to model the binary outcome of transitioned to oral feeding (y/n) defined as at least 90 percent of calories consumed orally. Fixed effects (dummy variables) will be entered for each site as described by McNeish and Stapleton (2016) to account for the clustering of the participants within sites. This will result in essentially, a logistic regression model with appropriate standard errors.||||
70900737|NCT03815019|141290020|SUPERIORITY||Odds Ratio, log|9.1544|STANDARD_ERROR_OF_MEAN|13083.0|||TWO_SIDED||||||||Participants in the placebo group who successfully transitioned to oral feeding.|Analysis conducted using Generalized Linear Mixed Models with a logit link within SAS Proc GLIMMIX to model the binary outcome of transitioned to oral feeding (y/n) defined as at least 90 percent of calories consumed orally. Fixed effects (dummy variables) will be entered for each site as described by McNeish and Stapleton (2016) to account for the clustering of the participants within sites. This will result in essentially, a logistic regression model with appropriate standard errors.||||
70900738|NCT03815019|141290022|SUPERIORITY||Mean Difference (Final Values)|0.08|||||TWO_SIDED||||||||Pr(\>F) = 0.7846, Nested model using site as a predictor|||||
70900739|NCT03815019|141290023|SUPERIORITY||Mean Difference (Final Values)|0.15|||||TWO_SIDED||||||||Pr(\>F) = 0.7025, Nested model using site as a predictor|||||
70900740|NCT03815019|141290024|SUPERIORITY||Mean Difference (Final Values)|0.18|||||TWO_SIDED||||||||Pr(\>F) = 0.6764, Nested model using site as a predictor|||||
70900741|NCT03815019|141290025|SUPERIORITY||Mean Difference (Final Values)|0.09|||||TWO_SIDED||||||||Pr(\>F) = 0.7649, Nested model using site as a predictor|||||
70900742|NCT03815019|141290026|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED||||||||Pr(\>F) = 0.9487, Nested model using site as a predictor|||||
70900743|NCT03815019|141290027|SUPERIORITY||Mean Difference (Final Values)|0.09|||||TWO_SIDED||||||||Pr(\>F) = 0.7669, Nested model using site as a predictor|||||
70900744|NCT03815019|141290028|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED||||||||Pr(\>F) = 0.5883, Nested model using site as a predictor|||||
70900745|NCT03815019|141290029|SUPERIORITY||Mean Difference (Final Values)|0.52|||||TWO_SIDED||||||||Pr(\>F) = 0.4749, Nested model using site as a predictor|||||
70900746|NCT03815019|141290030|SUPERIORITY||Mean Difference (Final Values)|0.02|||||TWO_SIDED||||||||Pr(\>F) = 0.8781, Nested model using site as a predictor|||||
70900747|NCT03937219|141290037|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0131|TWO_SIDED|95.0|0.57|0.94|||Log Rank|||||0.94|0.57|0.0131
70900748|NCT04803214|141290039|SUPERIORITY||||||<|0.001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.001
70900749|NCT04803214|141290040|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70900750|NCT04803214|141290041|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70900751|NCT00985010|141290042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.0|STANDARD_DEVIATION|5.0||0.05|||||||Chi-squared||The difference is between the percentage of deaths (males versus females) after six months in the patients with hepatic encephalophathy.|Clinical evolution was reported as percentage (still alive or death after six months of follow up).||||0.05
70900752|NCT00985010|141290043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.05|STANDARD_DEVIATION|10.72||0.05||95.0|||||Wilcoxon (Mann-Whitney)||The difference is between manganese levels of women minus manganese levels of men.|Laboratory results were expressed in means and standard deviations. Between group comparisons (female versus male values) were made with the Mann-Whitney U test using the Statistical Package for Social Sciences (SPSS) program version 10 (SPSS Inc., North Carolina, USA).||||0.05
70900753|NCT03764072|141290044|SUPERIORITY|||||||0.2107||||||Dose response Model - Linear|Multiple Comparison Procedure-Modelling|||||||0.2107
70900754|NCT03764072|141290044|SUPERIORITY|||||||0.0766||||||Dose response Model - Emax|Multiple Comparison Procedure-Modelling|||||||0.0766
70900755|NCT03764072|141290044|SUPERIORITY|||||||0.0989||||||Dose response Model - Logistic|Multiple Comparison Procedure-Modelling|||||||0.0989
70900756|NCT03764072|141290044|SUPERIORITY|||||||0.0927||||||Dose-response Model - Sigmoid Emax|Multiple Comparison Procedure-Modelling|||||||0.0927
70900757|NCT03764072|141290046|SUPERIORITY|||||||0.3162|||||||Cochran-Mantel-Haenszel|||||||0.3162
70900758|NCT03764072|141290046|SUPERIORITY|||||||0.4613|||||||Cochran-Mantel-Haenszel|||||||0.4613
70900759|NCT03764072|141290046|SUPERIORITY|||||||0.4095|||||||Cochran-Mantel-Haenszel|||||||0.4095
70900760|NCT03764072|141290046|SUPERIORITY|||||||0.157|||||||Cochran-Mantel-Haenszel|||||||0.1570
70900761|NCT03764072|141290046|SUPERIORITY|||||||0.9843|||||||Cochran-Mantel-Haenszel|||||||0.9843
70900762|NCT03764072|141290047|SUPERIORITY|||||||0.8714|||||||Cochran-Mantel-Haenszel|||||||0.8714
70900763|NCT03764072|141290047|SUPERIORITY|||||||0.5815|||||||Cochran-Mantel-Haenszel|||||||0.5815
70900764|NCT03764072|141290047|SUPERIORITY|||||||0.4308|||||||Cochran-Mantel-Haenszel|||||||0.4308
70900765|NCT03764072|141290047|SUPERIORITY|||||||0.4434|||||||Cochran-Mantel-Haenszel|||||||0.4434
70900766|NCT03764072|141290047|SUPERIORITY|||||||0.855|||||||Cochran-Mantel-Haenszel|||||||0.8550
70900767|NCT03764072|141290048|SUPERIORITY|||||||0.687|||||||Cochran-Mantel-Haenszel|||||||0.6870
70900768|NCT03764072|141290048|SUPERIORITY|||||||0.1515|||||||Cochran-Mantel-Haenszel|||||||0.1515
70900769|NCT03764072|141290048|SUPERIORITY|||||||0.603|||||||Cochran-Mantel-Haenszel|||||||0.6030
70900770|NCT03764072|141290048|SUPERIORITY|||||||0.1361|||||||Cochran-Mantel-Haenszel|||||||0.1361
70900771|NCT03764072|141290048|SUPERIORITY|||||||0.564|||||||Cochran-Mantel-Haenszel|||||||0.5640
70900772|NCT03764072|141290049|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.5405|TWO_SIDED|95.0|0.6|2.67|||Regression, Cox|||||2.67|0.60|0.5405
70900773|NCT03764072|141290049|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.9011|TWO_SIDED|95.0|0.49|2.27|||Regression, Cox|||||2.27|0.49|0.9011
70900774|NCT03764072|141290049|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9127|TWO_SIDED|95.0|0.48|2.26|||Regression, Cox|||||2.26|0.48|0.9127
70900775|NCT03764072|141290049|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.5619|TWO_SIDED|95.0|0.6|2.56|||Regression, Cox|||||2.56|0.60|0.5619
70900776|NCT03764072|141290049|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.709|TWO_SIDED|95.0|0.5|2.79|||Regression, Cox|||||2.79|0.50|0.7090
70900777|NCT03764072|141290050|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.5141|TWO_SIDED|95.0|0.61|2.72|||Regression, Cox|||||2.72|0.61|0.5141
70900778|NCT03764072|141290050|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.9614|TWO_SIDED|95.0|0.45|2.12|||Regression, Cox|||||2.12|0.45|0.9614
70900779|NCT03764072|141290050|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9756|TWO_SIDED|95.0|0.46|2.14|||Regression, Cox|||||2.14|0.46|0.9756
70900780|NCT03764072|141290050|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.5582|TWO_SIDED|95.0|0.6|2.57|||Regression, Cox|||||2.57|0.60|0.5582
70900781|NCT03764072|141290050|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.7543|TWO_SIDED|95.0|0.49|2.71|||Regression, Cox|||||2.71|0.49|0.7543
70900782|NCT00558064|141290057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.11|STANDARD_ERROR_OF_MEAN|0.57|<|0.0001|TWO_SIDED|95.0|3.98|6.23|||Mixed Models Analysis||Difference calculated as telmisartan 40 mg plus amlodipine 5 mg fixed-dose combination minus amlodipine 5 mg monotherapy|||6.23|3.98|<0.0001
70900783|NCT03152084|141290069|OTHER|Within-group change|Least square mean|-5.21||||0.4462|TWO_SIDED|95.0|-19.542|9.12||Start of treatment vs baseline|Mixed Models Analysis|||||9.120|-19.542|0.4462
70900784|NCT03152084|141290070|OTHER|Within-group change|Least square mean|3.69||||0.7842|TWO_SIDED|95.0|-24.817|32.195||End of treatment vs baseline|Mixed Models Analysis|||||32.195|-24.817|0.7842
70900785|NCT03152084|141290070|OTHER|Within-group change|Least square mean|-16.72||||0.0581|TWO_SIDED|95.0|-34.109|0.664||Follow-up vs End of treatment|Regression, Linear|||||0.664|-34.109|0.0581
70900786|NCT03152084|141290071|OTHER|Within-group change|Least square mean|344.85|||<|0.0001|TWO_SIDED|95.0|272.785|416.905||Start of treatment vs baseline|Mixed Models Analysis|||||416.905|272.785|<0.0001
70900787|NCT03152084|141290072|OTHER|Within-group change|Least square mean|311.3|||<|0.0001|TWO_SIDED|95.0|224.528|398.064||End of treatment vs baseline|Mixed Models Analysis|||||398.064|224.528|<0.0001
70900788|NCT03152084|141290073|OTHER|Within-group change|Least square mean|-203.07|||<|0.0001|TWO_SIDED|95.0|-235.983|-170.162||Follow-up vs end of treatment|Regression, Linear|||||-170.162|-235.983|<0.0001
70900789|NCT03152084|141290074|OTHER|Within-group change|Least square mean|-5.2658||||0.0047|TWO_SIDED|95.0|-8.5459|-1.9856||Start of treatment vs baseline|Mixed Models Analysis|||||-1.9856|-8.5459|0.0047
70900790|NCT03152084|141290075|OTHER|Within-group change|Least square mean|-7.0987||||0.0003|TWO_SIDED|95.0|-10.0379|-4.1595||End of treatment vs baseline|Mixed Models Analysis|||||-4.1595|-10.0379|0.0003
70900791|NCT03152084|141290076|OTHER|Within-group change|Least square mean|0.7287||||0.5592|TWO_SIDED|95.0|-1.9894|3.4468||Follow-up vs end of treatment|Regression, Linear|||||3.4468|-1.9894|0.5592
70900792|NCT03152084|141290077|OTHER|Within-group change|Least square mean|0.0315||||0.9288|TWO_SIDED|95.0|-0.7274|0.7904||Start of treatment vs baseline|Mixed Models Analysis|||||0.7904|-0.7274|0.9288
70900793|NCT03152084|141290078|OTHER|Within-group change|Least square mean|-0.4318||||0.1659|TWO_SIDED|95.0|-1.0761|0.2125||End of treatment vs baseline|Mixed Models Analysis|||||0.2125|-1.0761|0.1659
70900794|NCT03152084|141290079|OTHER|Within-group change|Least square mean|0.4755||||0.019|TWO_SIDED|95.0|0.0963|0.8548||Follow-up vs end of treatment|Regression, Linear|||||0.8548|0.0963|0.0190
70900795|NCT03152084|141290080|OTHER|Within-group change|Least square mean|-0.6713||||0.0157|TWO_SIDED|95.0|-1.1914|-0.1511||Start of treatment vs baseline|Mixed Models Analysis|||||-0.1511|-1.1914|0.0157
70900796|NCT03152084|141290081|OTHER|Within-group change|Least square mean|-0.0324||||0.87|TWO_SIDED|95.0|-0.4631|0.3984||End of treatment vs baseline|Mixed Models Analysis|||||0.3984|-0.4631|0.8700
70900797|NCT03152084|141290082|OTHER|Within-group change|Least square mean|0.1718||||0.2446|TWO_SIDED|95.0|-0.1358|0.4795||Follow-up vs end of treatment|Regression, Linear|||||0.4795|-0.1358|0.2446
70900798|NCT03152084|141290083|OTHER|Within-group change|Least square mean|-2.1||||0.0023|TWO_SIDED|95.0|-3.299|-0.902||Start of treatment vs baseline|Mixed Models Analysis|||||-0.902|-3.299|0.0023
70900799|NCT03152084|141290083|OTHER|Within-group change|Least square mean|-1.59|||<|0.0001|TWO_SIDED|95.0|-1.929|-1.256||End of treatment vs baseline|Mixed Models Analysis|||||-1.256|-1.929|<0.0001
70900800|NCT03152084|141290083|OTHER|Within-group change|Least square mean|3.88||||0.0002|TWO_SIDED|95.0|2.215|5.553||Follow-up vs end of treatment|Regression, Linear|||||5.553|2.215|0.0002
70900801|NCT03750006|141290136|SUPERIORITY|||||||0.0238||||||Not adjusted for multiple comparisons, P \< 0.05 is considered significant.|t-test, 2 sided|paired T-test||||||0.0238
70900802|NCT03750006|141290137|SUPERIORITY|||||||0.3029|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.3029
70900803|NCT03750006|141290138|SUPERIORITY|||||||0.1713|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.1713
70900804|NCT03750006|141290139|SUPERIORITY|||||||0.1261|||||||t-test, 2 sided|paired, P \< 0.05 is considered significant.||||||0.1261
70900805|NCT03750006|141290140|SUPERIORITY|||||||0.1367|||||||t-test, 2 sided|paired, P \< 0.05 is considered significant.||||||0.1367
70900806|NCT03750006|141290141|SUPERIORITY|||||||0.0111|||||||t-test, 2 sided|paired, P \< 0.05 is considered significant.||||||0.0111
70900807|NCT03750006|141290142|SUPERIORITY|||||||0.0219|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.0219
70900808|NCT03750006|141290143|SUPERIORITY|||||||0.366|||||||t-test, 2 sided|Paired, P \< 0.05 considered significant.||||||0.3660
70900809|NCT03750006|141290146|SUPERIORITY|||||||0.1563|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.1563
70900810|NCT03750006|141290147|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.0110
70900811|NCT03750006|141290148|OTHER|||||||0.3282|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.3282
70900812|NCT03750006|141290149|SUPERIORITY|||||||0.5244|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.5244
70900813|NCT03750006|141290150|SUPERIORITY|||||||0.5718|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.5718
70900814|NCT00811382|141290157|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
70900815|NCT03881696|141290186|SUPERIORITY||Odds Ratio (OR)|27.853|||<|1e-05|TWO_SIDED|95.0|9.1274|111.2144||The a priori threshold for statistical significance was p \< 0.0001 at the interim analysis OR p \< 0.05 at the final analysis. Gatekeeping and multiple testing strategies were performed to ensure the overall family-wise error rate was ≤ 5%.|Fisher Exact||The odds ratio (OR) represents the odds of success among subjects randomized to omalizumab (numerator) compared to the odds of success among subjects randomized to placebo (denominator, reference group).|The null hypothesis is that the odds of 'success' (defined as consumption of a single dose of ≥600 mg of peanut protein without dose-limiting symptoms during the DBPCFC at the end of Stage 1) in omalizumab and placebo for omalizumab arms are equal. Participants missing the blinded OFC to peanut at the end of Stage 1 will be considered a 'failure' for the primary efficacy endpoint.||111.2144|9.1274|<0.00001
70900816|NCT05690776|141290283|SUPERIORITY||Mean Difference (Final Values)|12.1|STANDARD_DEVIATION|10.0|<|0.0001|TWO_SIDED|95.0|9.2|15.0|||paired t-test|||||15.0|9.2|<0.0001
70900817|NCT05690776|141290284|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_DEVIATION|0.133|<|0.0001|TWO_SIDED|95.0|0.053|0.128|||paired t-test|||||0.128|0.053|<0.0001
70900818|NCT05690776|141290286|SUPERIORITY||Mean Difference (Final Values)|20.7|STANDARD_DEVIATION|13.2|<|0.0001|TWO_SIDED|95.0|16.9|24.5|||paired t-test|||||24.5|16.9|<0.0001
70900819|NCT02347657|141290302|SUPERIORITY||Least Squares (LS) Mean Difference|4.0|||<|0.0001|TWO_SIDED|95.0|3.1|4.8|||Mixed model for repeated measures (MMRM)|||Testing was performed according to the hierarchical testing procedure to control the overall type I error for tested at α = 0.05.||4.8|3.1|<0.0001
70900820|NCT02347657|141290303|SUPERIORITY||LS mean difference|6.8|||<|0.0001|TWO_SIDED|95.0|5.3|8.3|||MMRM|||Testing was performed according to the hierarchical testing procedure to control the overall type I error for tested at α = 0.05.||8.3|5.3|<0.0001
70900821|NCT02347657|141290304|SUPERIORITY||Event Rate Ratio|0.65||||0.0054|TWO_SIDED|95.0|0.48|0.88|||Negative Binomial Regression|||Testing was performed according to the hierarchical testing procedure to control the overall type I error for tested at α = 0.05.||0.88|0.48|0.0054
70900822|NCT02347657|141290305|SUPERIORITY||LS mean difference|0.06||||0.4127|TWO_SIDED|95.0|-0.08|0.19|||MMRM|||Testing was performed according to the hierarchical testing procedure to control the overall type I error for tested at α = 0.05.||0.19|-0.08|0.4127
70900823|NCT02709005|141290317|SUPERIORITY||Risk Difference (RD)|-0.08||||0.42|TWO_SIDED|95.0|-0.26|0.08||The test was conducted using a Fisher's exact test at the 5% two-sided level of significance level without adjustment for multiplicity.|Fisher Exact||Difference in Proportion of Participants with Clinical Cure between 5% Monolaurin Vaginal Gel and Placebo Gel|The null hypothesis was that there was no difference in participants with clinical cure between study arms, with a two-sided alternative considering the possibility of a difference in either direction. The statistical informational goal for the study of 90 participants eligible in the modified Intent-to-Treat (mITT) efficacy population was an ad-hoc sample size determined by logistical considerations, as there was insufficient pilot data upon which to base more formal sample size calculations.||0.08|-0.26|0.420
70900824|NCT02709005|141290318|SUPERIORITY||Risk Difference (RD)|0.14||||0.2|TWO_SIDED|95.0|-0.06|0.33||The test was conducted using a Fisher's exact test at the 5% two-sided level of significance level without adjustment for multiplicity.|Fisher Exact||Difference in Proportion of Participants Experiencing Solicited Events between 5% Monolaurin Vaginal Gel and Placebo Gel|The null hypothesis was that there was no difference in participants with solicited urogenital AEs between study arms, with a two-sided alternative considering the possibility of a difference in either direction.||0.33|-0.06|0.200
70900825|NCT02709005|141290319|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|||||No SAEs were reported; therefore the Fisher's Exact Test was not performed.||||The null hypothesis was that there was no difference in participants with related SAEs between study arms, with a two-sided alternative considering the possibility of a difference in either direction.||||
70900826|NCT02709005|141290320|SUPERIORITY||Risk Difference (RD)|0.0|||>|0.999|TWO_SIDED|95.0|-0.13|0.08||The test was conducted using a Fisher's exact test at the 5% two-sided level of significance level without adjustment for multiplicity.|Fisher Exact||Difference in Proportion of Participants with Therapeutic Cure between 5% Monolaurin Vaginal Gel and Placebo Gel|The null hypothesis was that there was no difference in participants with therapeutic cure between study arms, with a two-sided alternative considering the possibility of a difference in either direction.||0.08|-0.13|>0.999
70900827|NCT02709005|141290321|SUPERIORITY||Risk Difference (RD)|-0.09||||0.035|TWO_SIDED|95.0|-0.24|-0.01||The test was conducted using a Fisher's exact test at the 5% two-sided level of significance level without adjustment for multiplicity.|Fisher Exact||Difference in Proportion of Participants with Therapeutic Cure between 5% Monolaurin Vaginal Gel and Placebo Gel|The null hypothesis was that there was no difference in participants with therapeutic cure between study arms, with a two-sided alternative considering the possibility of a difference in either direction.||-0.01|-0.24|0.035
70900828|NCT02709005|141290326|SUPERIORITY||Risk Difference (RD)|0.0|||>|0.999|TWO_SIDED|95.0|-0.18|0.14||The test was conducted using a Fisher's exact test at the 5% two-sided level of significance level without adjustment for multiplicity.|Fisher Exact||Difference in Proportion of Participants with Clinical Cure between 5% Monolaurin Vaginal Gel and Placebo Gel|The null hypothesis was that there was no difference in participants with clinical cure between study arms, with a two-sided alternative considering the possibility of a difference in either direction.||0.14|-0.18|>0.999
70900829|NCT03532308|141290329|SUPERIORITY|||||||0.76||||||This is for the effect of treatment with time, risk stratification and treatment\*time interaction in the model.|Mixed Models Analysis|||||||0.76
70900830|NCT03720938|141290335|SUPERIORITY|A sample size of 26 children per group was needed with the assumption of Cohen's d = 0.8, the alpha error of 0.05 and a power of 80%.||||||0.001||||||The outcomes of weight was tested for any difference between groups by covariate analysis (ANCOVA) adjusted for the weight at baseline and confounding variable age.|ANCOVA|||Null hypothesis was the absence of difference between the two groups for the dependent variable weight.||||0.001
70900831|NCT03720938|141290335|OTHER|||||||0.0002535||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable weight.||||0.0002535
70900832|NCT03720938|141290335|SUPERIORITY|||||||0.000397||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable weight.||||0.000397
70900833|NCT03720938|141290336|SUPERIORITY|||||||0.005||||||The outcome of weight z score was tested for any difference between groups by covariate analysis (ANCOVA) adjusted for the weight at baseline and confounding variable age.|ANCOVA|||Null hypothesis was the absence of difference between the two groups for the dependent variable weight z scores.||||0.005
70900834|NCT03720938|141290336|SUPERIORITY|||||||0.002||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable weight z score.||||0.002
70900835|NCT03720938|141290336|SUPERIORITY|||||||0.00386||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality. Adjusted by Satterthwaite's degrees of freedom correction method for cluster effect, and small sample sizes in addition to baseline value and age.||||0.00386
70900836|NCT03720938|141290337|SUPERIORITY|||||||0||||||The outcomes of weight was tested for any difference between groups by covariate analysis (ANCOVA) adjusted for the body mass index at baseline and confounding variable age.|ANCOVA|||Null hypothesis was the absence of difference between the two groups for the dependent variable body mass index.||||0.000
70900837|NCT03720938|141290337|SUPERIORITY|||||||3.06e-06||||||"Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.~Adjusted for cluster effect, and small sample sizes, baseline value and age."|Linear mixed effects model|Satterthwaite's correction method for denominator degrees of freedom.||Null hypothesis was the absence of difference between the two groups for the dependent variable body mass index.||||0.00000306
70900838|NCT03720938|141290337|SUPERIORITY|||||||3.67e-06||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable body mass index.||||0.00000367
70900839|NCT03720938|141290338|SUPERIORITY|||||||0||||||The outcome of body mass index z score was tested for any difference between groups by covariate analysis (ANCOVA) adjusted for the body mass index z score at baseline and confounding variable age.|ANCOVA|||Null hypothesis was the absence of difference between the two groups for the dependent variable body mass index z score.||||0.000
70900840|NCT03720938|141290338|SUPERIORITY|||||||0.0001402||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable body mass index z score.||||0.0001402
70900841|NCT03720938|141290338|SUPERIORITY|||||||0.000235||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable body index z score.||||0.000235
70900842|NCT03720938|141290339|SUPERIORITY|||||||0.259||||||The outcomes of fat ratio was tested for any difference between groups by covariate analysis (ANCOVA) adjusted for the fat ratio at baseline and confounding variable age.|ANCOVA|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable fat ratio.||||0.259
70900843|NCT03720938|141290339|SUPERIORITY|||||||0.22||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable fat ratio.||||0.220
70900844|NCT03720938|141290339|SUPERIORITY|||||||0.250006||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable fat ratio.||||0.250006
70900845|NCT03720938|141290340|SUPERIORITY|||||||0||||||The outcome of visual reaction time was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for the weight at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable visual reaction time.||||0.000
70900846|NCT03720938|141290340|SUPERIORITY|Adjusted for the weight at baseline and confounding variable age.||||||1.196e-05||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted for cluster effect in addition to baseline value and age.||The outcome of visual reaction time was tested for any difference between groups by linear mixed-effects model analysis.||||0.00001196
70900847|NCT03720938|141290340|SUPERIORITY||||||‬|2.82e-05||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable visual reaction time.||||0.0000282‬
70900848|NCT03720938|141290341|SUPERIORITY|||||||0||||||The outcome of visual reaction time of non-dominant hand was tested for any difference between groups.|ANCOVA|Adjusted for the visual reaction time of non-dominant hand at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable visual reaction time of non-dominant hand.||||0.000
70900849|NCT03720938|141290341|SUPERIORITY|||||||9e-08||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable visual reaction time of non-dominant hand.||||0.00000009
70900850|NCT03720938|141290341|SUPERIORITY|||||||55||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable visual reaction time of non-dominant hand.||||000000055
70900851|NCT03720938|141290342|SUPERIORITY|||||||0||||||The outcomes of auditory reaction time of dominant hand was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for the auditory reaction time of dominant hand at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of dominant hand.||||0.000
70900852|NCT03720938|141290342|SUPERIORITY|||||||1.633e-05||||||The outcomes of auditory reaction time of dominant hand was tested for any difference between groups by linear mixed-effects analysis.|Linear mixed-effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of dominant hand.||||0.00001633
70900853|NCT03720938|141290342|SUPERIORITY|||||||3.67e-05||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of dominant hand.||||0.0000367
70900854|NCT03720938|141290343|SUPERIORITY|||||||0.008||||||The outcomes of auditory reaction time of non-dominant hand was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for the auditory reaction time of non-dominant hand at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of non-dominant hand.||||0.008
70900855|NCT03720938|141290343|SUPERIORITY|||||||0.006||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of non-dominant hand.||||0.006
70900856|NCT03720938|141290343|SUPERIORITY|||||||0.006602||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of non-dominant hand.||||0.006602
70900857|NCT03720938|141290344|SUPERIORITY|||||||0.615648||||||The outcome of self-perception for sports competence was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for sports competence at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of sports competence.||||0.615648
70900858|NCT03720938|141290344|SUPERIORITY|||||||0.608||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||The outcome of self-perception for sports competence was tested for any difference between groups by linear mixed-effects model analysis.||||0.608
70900859|NCT03720938|141290344|SUPERIORITY|||||||0.60938||||||The outcome of self-perception for sports competence was tested for any difference between groups by linear mixed-effects model analysis.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of sports competence.||||0.60938
70900860|NCT03720938|141290345|SUPERIORITY|||||||0.094||||||The outcome of self-perception for physical condition competence was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for physical condition competence at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of physical condition competence.||||0.094
70900861|NCT03720938|141290345|SUPERIORITY|||||||0.085||||||The outcome of self-perception for physical condition competence was tested for any difference between groups by linear mixed-effects model analysis.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of physical condition competence.||||0.085
70900862|NCT03720938|141290345|SUPERIORITY|||||||0.08818||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||The outcome of self-perception for sports competence was tested for any difference between groups by linear mixed-effects model analysis.||||0.08818
70900863|NCT03720938|141290346|SUPERIORITY|||||||0.058102||||||The outcome of self-perception for strength competence was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for strength competence at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of strength competence.||||0.058102
70900864|NCT03720938|141290346|SUPERIORITY|||||||0.051||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of strength competence.||||0.051
70900865|NCT03720938|141290346|SUPERIORITY|||||||0.0534||||||The outcome of self-perception for strength competence was tested for any difference between groups by linear mixed-effects model analysis.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of strength competence.||||0.0534
70900866|NCT03720938|141290347|SUPERIORITY|||||||0.638505||||||The outcome of self-perception for body attractiveness was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for body attractiveness at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of body attractiveness.||||0.638505
70900867|NCT03720938|141290347|SUPERIORITY|||||||0.632||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of body attractiveness.||||0.632
70900868|NCT03720938|141290347|SUPERIORITY|||||||0.6328||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of body attractiveness.||||0.63280
70900869|NCT03720938|141290348|SUPERIORITY|||||||0.007061||||||The outcome of self-perception of global physical self-worth was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for global physical self-worth at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global physical self-worth.||||0.007061
70900870|NCT03720938|141290348|SUPERIORITY|||||||0.005||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global physical self-worth.||||0.005
70900871|NCT03720938|141290348|SUPERIORITY|||||||0.00603||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global physical self-worth.||||0.00603
70900872|NCT03720938|141290349|SUPERIORITY|||||||0.002879||||||The outcome of self-perception for global self-worth was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for global self-worth at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global self-worth.||||0.002879
70900873|NCT03720938|141290349|SUPERIORITY|||||||0.002||||||The outcome of self-perception for sports competence was tested for any difference between groups by linear mixed-effects model analysis.|Linear mixed effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global self-worth.||||0.002
70900874|NCT03720938|141290349|SUPERIORITY|||||||0.00238||||||The outcome of self-perception for sports competence was tested for any difference between groups by linear mixed-effects model analysis.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global self-worth.||||0.00238
70900875|NCT03720938|141290350|SUPERIORITY|||||||0.194||||||Tested the significance of gender between genders|Wilcoxon (Mann-Whitney)|||"Enjoyment scale of physical activity sports in intervention group between male and female genders"||||0.194
70900876|NCT03720938|141290351|SUPERIORITY|||||||0.809|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was the absence of difference between the two genders in the Active video game group for the variable of enjoyment from sports category.||||0.809
70900877|NCT03720938|141290352|SUPERIORITY|||||||0.843|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was the absence of difference between the two genders in the active video game group for the variable of enjoyment from balance category.||||0.843
70900878|NCT03720938|141290353|SUPERIORITY|||||||0.247|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was the absence of difference between the two genders in the active video game group for the variable of enjoyment from aerobic category.||||0.247
70900879|NCT03720938|141290354|SUPERIORITY|||||||0.543|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was the absence of difference between the two genders in the active video game group for the variable of enjoyment from training category.||||0.543
70900880|NCT00499863|141290355|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||The null hypothesis was that there is no difference between MTS and placebo.||||< 0.001
70900881|NCT00499863|141290356|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||< 0.001
70900882|NCT00499863|141290357|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
70900883|NCT00499863|141290358|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
70900884|NCT00499863|141290359|SUPERIORITY_OR_OTHER|||||||0.288||95.0|||||ANCOVA|||||||0.288
70900885|NCT00571701|141290367|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
70900886|NCT00571701|141290368|SUPERIORITY_OR_OTHER|||||||0.43|||||||Fisher Exact|||||||0.43
70900887|NCT00571701|141290369|SUPERIORITY_OR_OTHER||||||>|0.3||||||Adjusted for multiple comparisons|Fisher Exact|||||||>0.3
70900888|NCT00571701|141290370|SUPERIORITY_OR_OTHER|||||||1||||||Adjusted for multiple comparisons|Fisher Exact|||||||1.00
70900889|NCT00571701|141290371|SUPERIORITY_OR_OTHER||||||>|0.5||||||Adjusted for multiple comparisons|Fisher Exact|||||||> 0.5
70900890|NCT00571701|141290372|SUPERIORITY_OR_OTHER||||||>|0.56|||||||t-test, 2 sided|||||||>0.56
70900891|NCT00532155|141290444|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.8985|TWO_SIDED|95.0|0.868|1.174|||Stratified log-rank test|Stratified on ECOG Performance Status (0 vs 1 vs 2) and Prior Bevacizumab (yes vs no) according to IVRS.||||1.174|0.868|0.8985
70900892|NCT00532155|141290445|SUPERIORITY_OR_OTHER_LEGACY||Stratified Hazard ratio|0.819||||0.0035|TWO_SIDED|95.0|0.716|0.937|||Stratified Log-Rank test|Stratified on ECOG Performance Status (0 vs 1 vs 2) and Prior Bevacizumab (yes vs no) according to IVRS.|Stratified on ECOG Performance Status (0 vs 1 vs 2) and Prior Bevacizumab (yes vs no) according to IVRS.|||0.937|0.716|0.0035
70900893|NCT02134925|141290455|SUPERIORITY|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|||||||0.0004
70900894|NCT02134925|141290460|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||||||0.0001
70900895|NCT01091948|141290469|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Regression, Cox|Intubations accomplished with another device due to difficulty with assigned device and those took \>180 s were considered as failed intubations.||||||0.19
70900896|NCT01091948|141290470|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.89||||0.58|TWO_SIDED|95.0|0.58|1.35|||ANCOVA||The mean intubation difficulty score was tested after logarithmic transformation, and then back transformed for the estimated treatment effect.|||1.35|0.58|0.58
70900897|NCT01091948|141290471|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.13||||0.15|TWO_SIDED|95.0|0.95|1.33|||Cochran-Mantel-Haenszel|||||1.33|0.95|0.15
70900898|NCT01091948|141290472|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.67||||0.57|TWO_SIDED|95.0|0.28|10.2|||Cochran-Mantel-Haenszel|||||10.2|0.28|0.57
70900899|NCT01091948|141290473|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.01||||0.79|TWO_SIDED|95.0|0.93|1.09|||Cochran-Mantel-Haenszel|||||1.09|0.93|0.79
70900900|NCT01091948|141290474|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.82|TWO_SIDED|95.0|0.45|2.76|||Regression, Logistic|proportional odds logistic regression model||||2.76|0.45|0.82
70900901|NCT00462280|141290507|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.61
70900902|NCT01313286|141290538|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Square means|1.08|||||TWO_SIDED|90.0|1.0|1.16|||Mixed Models Analysis|Ratio of test formulation (HCl salt) to reference formulation (free base).||||1.16|1.00|
70900903|NCT01313286|141290539|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Square means|1.18|||||TWO_SIDED|90.0|1.07|1.31|||Mixed Models Analysis|Ratio of test formulation (HCl salt) to reference formulation (free base).||||1.31|1.07|
70900904|NCT00079001|141290563|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Superiority and futility analysis were conducted for time to first SRE. Lan-Demets analog of the Emerson-Fleming sequential boundary was used to maintain overall significance level of α = .05 while conducting interim analyses on time to first SRE.|Hazard Ratio (HR)|0.97||||0.385|TWO_SIDED|95.0|0.0|1.174||Because of early termination, conditional power was performed under the alternative hypothesis. This is the probability that zoledronic acid is superior to placebo, given time to first SRE data at interim analysis under alternative hypothesis.|Log Rank||Patients randomly assigned to zoledronic acid were compared with patients assigned to placebo|The null hypothesis was that the hazard ratio is greater than or equal to 1.0 versus the alternative hypothesis that the hazard ratio is less than 0.77. With a target of 470 SREs, log-rank statistic had 88% power to detect a 23% decrease in hazard of SRE (equivalent to an increase in median time to SRE from 30 months to 39 months), assuming a one-sided type I error rate of .05.||1.174|0|0.385
70900905|NCT00079001|141290564|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.29|TWO_SIDED|95.0|0.7|1.12|||Log Rank|Adjusted for stratification factors: performance status, prior SRE, and serum alkaline phosphatase.|Zoledronic acid versus placebo group|||1.12|0.70|0.29
70900906|NCT00079001|141290565|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.89||||0.22|TWO_SIDED|95.0|0.74|1.07|||Log Rank|Adjusted for stratification factors: performance status, prior SRE, and serum alkaline phosphatase.|Zoledronic acid versus placebo group|||1.07|0.74|0.22
70900907|NCT02332590|141290566|SUPERIORITY||LS Mean Difference|-1.077|||<|0.0001|TWO_SIDED|95.0|-1.361|-0.793||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg vs. Adalimumab 40 mg|Analysis was performed using MMRM approach with treatment, region, visits, and treatment-by-visit interaction as fixed effects and baseline DAS28-ESR score as a continuous covariate. Hierarchical testing procedure was used to control overall alpha error rate at 0.05 level and handle multiple endpoint analyses. Testing was then performed sequentially in order endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-0.793|-1.361|<0.0001
70900908|NCT02332590|141290567|SUPERIORITY||Odds Ratio (OR)|4.879|||<|0.0001|TWO_SIDED|95.0|2.536|9.389||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified by region.||9.389|2.536|<0.0001
70900909|NCT02332590|141290568|SUPERIORITY||Odds Ratio (OR)|1.976||||0.0017|TWO_SIDED|95.0|1.289|3.028||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified by region.||3.028|1.289|0.0017
70900910|NCT02332590|141290569|SUPERIORITY||Odds Ratio (OR)|2.286||||0.0036|TWO_SIDED|95.0|1.3|4.02||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified by region.||4.020|1.300|0.0036
70900911|NCT02332590|141290570|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0074|TWO_SIDED|95.0|1.168|2.773||Threshold for significance 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified by region.||2.773|1.168|0.0074
70900912|NCT02332590|141290571|SUPERIORITY||LS Mean Difference|-0.182||||0.0037|TWO_SIDED|95.0|-0.305|-0.059||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using MMRM approach with treatment, region, visits, and treatment-by-visit interaction as fixed effects and baseline HAQ-DI score as a continuous covariate.||-0.059|-0.305|0.0037
70900913|NCT02332590|141290572|SUPERIORITY||LS Mean Difference|2.65||||0.0006|TWO_SIDED|95.0|1.147|4.153||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using MMRM approach with treatment, region, visits, and treatment-by-visit interaction as fixed effects and baseline SF-36 PCS score as a continuous covariate.||4.153|1.147|0.0006
70900914|NCT02332590|141290573|SUPERIORITY||LS Mean Difference|1.768||||0.0689|TWO_SIDED|95.0|-0.137|3.674||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using MMRM approach with treatment, region, visits, and treatment-by-visit interaction as fixed effects and baseline FACIT-F score as a continuous covariate.||3.674|-0.137|0.0689
70900915|NCT00916032|141290619|SUPERIORITY_OR_OTHER_LEGACY|||||||0.103||95.0|||||paired t-test done on the Log(AUC 0-48h)|||||||0.103
70900916|NCT00916032|141290620|SUPERIORITY_OR_OTHER_LEGACY|||||||0.162||95.0|||||paired t-test done on the Log(AUC 0-48h)|||||||0.162
70900917|NCT01392300|141290708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.7|-0.3|||ANCOVA|||||-0.3|-0.7|<0.001
70900918|NCT01392300|141290709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.11||0.003|TWO_SIDED|95.0|0.1|0.5|||ANCOVA|||||0.5|0.1|0.003
70900919|NCT01392300|141290710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.28|||<|0.001|TWO_SIDED|95.0|2.43|7.52|||Regression, Logistic|||||7.52|2.43|<0.001
70900920|NCT01392300|141290711|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.69|||<|0.001|TWO_SIDED|95.0|1.56|4.63|||Regression, Logistic|||||4.63|1.56|<0.001
70900921|NCT01392300|141290712|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.48||||0.004|TWO_SIDED|95.0|1.33|4.61|||Regression, Logistic|||||4.61|1.33|0.004
70900922|NCT01392300|141290713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.13|||<|0.001|TWO_SIDED|95.0|1.76|5.57|||Regression, Logistic|||||5.57|1.76|<0.001
70900923|NCT01392300|141290714|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92||||0.021|TWO_SIDED|95.0|1.1|3.34|||Regression, Logistic|||||3.34|1.10|0.021
70900924|NCT01392300|141290715|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.58||||0.006|TWO_SIDED|95.0|1.32|5.05|||Regression, Logistic|||||5.05|1.32|0.006
70900925|NCT01392300|141290716|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.72|||<|0.001|TWO_SIDED|95.0|2.06|6.72|||Regression, Logistic|||||6.72|2.06|<0.001
70900926|NCT01392300|141290717|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.002|TWO_SIDED|95.0|1.4|4.46|||Regression, Logistic|||||4.46|1.40|0.002
70900927|NCT01392300|141290718|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.102|TWO_SIDED|95.0|0.9|3.22|||Regression, Logistic|||||3.22|0.90|0.102
70900928|NCT01392300|141290719|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.95|||<|0.001|TWO_SIDED|95.0|1.67|5.23|||Regression, Logistic|||||5.23|1.67|<0.001
70900929|NCT01392300|141290720|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.46||||0.002|TWO_SIDED|95.0|1.37|4.41|||Regression, Logistic|||||4.41|1.37|0.002
70900930|NCT01392300|141290721|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87||||0.069|TWO_SIDED|95.0|0.95|3.69|||Regression, Logistic|||||3.69|0.95|0.069
70900931|NCT01392300|141290722|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05||||0.034|TWO_SIDED|95.0|1.05|4.0|||Regression, Logistic|||||4.00|1.05|0.034
70900932|NCT01392300|141290723|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.169|TWO_SIDED|95.0|0.82|3.16|||Regression, Logistic|||||3.16|0.82|0.169
70900933|NCT01392300|141290724|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.92|TWO_SIDED|95.0|0.49|2.18|||Regression, Logistic|||||2.18|0.49|0.920
70900934|NCT01392300|141290725|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.56|||<|0.001|TWO_SIDED|95.0|1.83|6.91|||Regression, Logistic|||||6.91|1.83|<0.001
70900935|NCT01392300|141290726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.41||||0.007|TWO_SIDED|95.0|1.28|4.56|||Regression, Logistic|||||4.56|1.28|0.007
70900936|NCT01392300|141290727|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.26||||0.018|TWO_SIDED|95.0|1.15|4.41|||Regression, Logistic|||||4.41|1.15|0.018
70900937|NCT01392300|141290728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|||||-0.2|-0.5|<0.001
70900938|NCT01392300|141290729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09||0.011|TWO_SIDED|95.0|-0.4|-0.1|||ANCOVA|||||-0.1|-0.4|0.011
70900939|NCT01392300|141290730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.032|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.032
70900940|NCT01392300|141290731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.6|-0.2|||ANCOVA|||||-0.2|-0.6|<0.001
70900941|NCT01392300|141290732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA|||||-0.1|-0.5|<0.001
70900942|NCT01392300|141290733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.029|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.029
70900943|NCT01392300|141290734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|||||-0.2|-0.5|<0.001
70900944|NCT01392300|141290735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09||0.019|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|0.019
70900945|NCT01392300|141290736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.137|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.137
70900946|NCT01392300|141290737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09||0.013|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|0.013
70900947|NCT01392300|141290738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.131|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.131
70900948|NCT01392300|141290739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.714|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.714
70900949|NCT01392300|141290740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|||||-0.2|-0.5|<0.001
70900950|NCT01392300|141290741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09||0.008|TWO_SIDED|95.0|-0.4|-0.1|||ANCOVA|||||-0.1|-0.4|0.008
70900951|NCT01392300|141290742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.062|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.062
70900952|NCT01392300|141290743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.006|TWO_SIDED|95.0|-0.4|-0.1|||ANCOVA|||||-0.1|-0.4|0.006
70900953|NCT01392300|141290744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.076|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.076
70900954|NCT01392300|141290745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.416|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.416
70900955|NCT01392300|141290746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.4|-0.1|||ANCOVA|||||-0.1|-0.4|<0.001
70900956|NCT01392300|141290747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.175|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||||0.1|-0.3|0.175
70900957|NCT01392300|141290748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.14|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.140
70900958|NCT01392300|141290749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.007|TWO_SIDED|95.0|-0.4|-0.1|||ANCOVA|||||-0.1|-0.4|0.007
70900959|NCT01392300|141290750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.018|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.018
70900960|NCT01392300|141290751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.105|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.105
70900961|NCT01392300|141290752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.016|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|0.016
70900962|NCT01392300|141290753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.014|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|0.014
70900963|NCT01392300|141290754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.22|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.220
70900964|NCT01392300|141290755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.429|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.429
70900965|NCT01392300|141290756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.884|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|||||0.2|-0.2|0.884
70900966|NCT01392300|141290757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.844|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|||||0.2|-0.2|0.844
70900967|NCT01342458|141290769|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Mixed Models Analysis|||Sample size was calculated based on pain WOMAC score and was accomplished using a moderate effect size (f=0.30). Standard deviation estimates were taken from our previous study. A sample size of 56 patients was needed to provide 80% power for detecting a moderate effect difference between the highest and lowest group pain means, with an alpha level of 0.05, a statistical design of F test of repeated measures (between and within effects), and assuming a 10% loss to follow-up.||||0.006
70900968|NCT01342458|141290769|SUPERIORITY_OR_OTHER||Effect Size|1.46|||<|0.001|TWO_SIDED||||||post hoc newman keuls|||From baseline to 3rd month.||||<0.001
70900969|NCT01342458|141290769|SUPERIORITY_OR_OTHER||Effect size|1.94|||<|0.001|TWO_SIDED||||||post hoc Newman Keuls|||From baseline to 6th month.||||<0.001
70900970|NCT01342458|141290769|SUPERIORITY_OR_OTHER||Effect size|0.82||||0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||0.001
70900971|NCT01342458|141290769|SUPERIORITY_OR_OTHER||Effect size|0.66|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
70900972|NCT01342458|141290770|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).||||0.015
70900973|NCT01342458|141290770|SUPERIORITY_OR_OTHER||Effect size|0.66|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
70900974|NCT01342458|141290770|SUPERIORITY_OR_OTHER||Effect size|0.7|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
70900975|NCT01342458|141290770|SUPERIORITY_OR_OTHER||Effect size|0.25|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
70900976|NCT01342458|141290770|SUPERIORITY_OR_OTHER||Effect size|0.16|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
70900977|NCT01342458|141290771|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls test to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).||||<0.001
70900978|NCT01342458|141290771|SUPERIORITY_OR_OTHER||Effect size|1.28|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
70900979|NCT01342458|141290771|SUPERIORITY_OR_OTHER||Effect size|1.58|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
70900980|NCT01342458|141290771|SUPERIORITY_OR_OTHER||Effect size|0.68|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
70900981|NCT01342458|141290771|SUPERIORITY_OR_OTHER||Effect size|0.42|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
70900982|NCT01342458|141290772|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls test to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).||||<0.001
70900983|NCT01342458|141290772|SUPERIORITY_OR_OTHER||Effect size|1.45|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
70900984|NCT01342458|141290772|SUPERIORITY_OR_OTHER||Effect size|1.69||||0.019|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||0.019
70900985|NCT01342458|141290772|SUPERIORITY_OR_OTHER||Effect size|0.66|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
70900986|NCT01342458|141290772|SUPERIORITY_OR_OTHER||Effect size|0.44|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
70900987|NCT01342458|141290773|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls test to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).||||0.019
70900988|NCT01342458|141290773|SUPERIORITY_OR_OTHER||Effect size|1.07|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
70900989|NCT01342458|141290773|SUPERIORITY_OR_OTHER||Effect size|1.31|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
70900990|NCT01342458|141290773|SUPERIORITY_OR_OTHER||Effect size|0.71|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
70900991|NCT01342458|141290773|SUPERIORITY_OR_OTHER||Effect size|0.45|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
70900992|NCT01342458|141290774|SUPERIORITY_OR_OTHER|||||||0.425|TWO_SIDED||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls test to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).||||0.425
70900993|NCT01342458|141290775|SUPERIORITY_OR_OTHER|||||||0.443|TWO_SIDED||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls test to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).||||0.443
70900994|NCT01342458|141290776|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|10.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference in paracetamol intake at 6-month.||||<0.001
70900995|NCT01181726|141290785|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|104.66|||||TWO_SIDED|90.0|94.22|116.25|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||116.25|94.22|
70900996|NCT01181726|141290786|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.4|||||TWO_SIDED|90.0|93.91|101.02|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.02|93.91|
70900997|NCT01181726|141290787|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.6|||||TWO_SIDED|90.0|94.05|101.3|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.30|94.05|
70900998|NCT01181726|141290788|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.35|||||TWO_SIDED|90.0|92.21|107.06|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||107.06|92.21|
70900999|NCT01181726|141290789|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.21|||||TWO_SIDED|90.0|91.21|99.39|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||99.39|91.21|
70901000|NCT01181726|141290790|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.25|||||TWO_SIDED|90.0|91.18|99.51|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||99.51|91.18|
70901001|NCT01181726|141290791|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.33|||||TWO_SIDED|90.0|92.21|107.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||107.00|92.21|
70901002|NCT01181726|141290792|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.19|||||TWO_SIDED|90.0|91.18|99.38|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||99.38|91.18|
70901003|NCT01181726|141290793|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.23|||||TWO_SIDED|90.0|91.17|99.47|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||99.47|91.17|
70901004|NCT01181726|141290794|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.92|||||TWO_SIDED|90.0|93.44|102.61|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.61|93.44|
70901005|NCT01181726|141290795|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.77|||||TWO_SIDED|90.0|93.92|101.78|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101.78|93.92|
70901006|NCT01181726|141290796|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.71|||||TWO_SIDED|90.0|94.42|105.3|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||105.30|94.42|
70901007|NCT01181726|141290797|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.19|||||TWO_SIDED|90.0|94.71|103.87|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||103.87|94.71|
70901008|NCT01181726|141290798|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.83|||||TWO_SIDED|90.0|94.55|101.21|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101.21|94.55|
70901009|NCT01181726|141290799|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.01|||||TWO_SIDED|90.0|94.54|101.6|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101.60|94.54|
70901010|NCT01181726|141290800|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.87|||||TWO_SIDED|90.0|93.22|102.74|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.74|93.22|
70901011|NCT01181726|141290801|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.96|||||TWO_SIDED|90.0|93.66|102.46|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.46|93.66|
70901012|NCT01181726|141290802|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.01|||||TWO_SIDED|90.0|94.17|104.11|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||104.11|94.17|
70901013|NCT01181726|141290803|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.13|||||TWO_SIDED|90.0|94.39|104.1|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||104.10|94.39|
70901014|NCT01181726|141290804|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.72|||||TWO_SIDED|90.0|94.03|101.56|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101.56|94.03|
70901015|NCT01181726|141290805|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.99|||||TWO_SIDED|90.0|94.11|102.02|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.02|94.11|
70901016|NCT01264380|141290806|SUPERIORITY_OR_OTHER||Ratio of Geometric Mean|4.64|||||TWO_SIDED|90.0|2.83|7.6||||||The point estimate and 90 percent (%) confidence interval (CI) of vemurafenib plasma AUC geometric means ratios of the Fed to Fasted conditions following an oral administration of a single dose of 960 mg vemurafenib were analyzed.||7.60|2.83|
70901017|NCT01264380|141290807|SUPERIORITY_OR_OTHER||Ratio of Geometric Mean|5.05|||||TWO_SIDED|90.0|2.99|8.55||||||The point estimate and 90% CI of vemurafenib plasma AUC geometric means ratios of the Fed to Fasted conditions following an oral administration of a single dose of 960 mg vemurafenib were analyzed.||8.55|2.99|
70901018|NCT01264380|141290808|SUPERIORITY_OR_OTHER||Ratio of Geometric Mean|2.45|||||TWO_SIDED|90.0|1.81|3.32||||||The point estimate and 90% CI of vemurafenib plasma Cmax geometric means ratios of the Fed to Fasted conditions following an oral administration of a single dose of 960 mg vemurafenib were analyzed.||3.32|1.81|
70901019|NCT01147822|141290815|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0184|||||TWO_SIDED|95.0|0.7658|1.3542|||||The HR was estimated by the Cox regression model using treatment stratification factors as covariates. The HR was adjusted for Karnofsky Performance Scale scores, prior nephrectomy, and Baseline levels of lactate dehydrogenase.|||1.3542|0.7658|
70901020|NCT01147822|141290816|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.08||||0.604|TWO_SIDED|95.0|0.808|1.441|||Log Rank||Hazard ratios were estimated using the Pike estimator. A hazard ratio \<1 indicates a lower risk with this treatment compared with Sunitinib.|||1.441|0.808|0.604
70901021|NCT04382924|141290824|SUPERIORITY||Odds Ratio, log|0.0001|||<|0.025|TWO_SIDED||||||Chi-squared|||||||<0.025
70901022|NCT03243422|141290857|SUPERIORITY||change in Standard Deviation|0.002||||0.96|TWO_SIDED|95.0|-0.077|0.081|||Mixed Models Analysis|Three-level linear mixed effects model with an unstructured covariance matrix from the baseline and the year 3 in-person neurocognitive assessment||||0.081|-0.077|0.96
70901023|NCT03243422|141290858|SUPERIORITY||Slope|0.079||||0.15|TWO_SIDED|95.0|-0.029|0.187||Secondary outcomes were evaluated with Hochberg modification to the Bonferroni adjustment estimates are considered statistically significant if the largest p-value is \<0·05.|Mixed Models Analysis|||||0.187|-0.029|0.15
70901024|NCT03243422|141290859|SUPERIORITY||Slope|-0.02||||0.69|TWO_SIDED|95.0|-0.118|0.078||Secondary outcomes were evaluated with Hochberg modification to the Bonferroni adjustment estimates are considered statistically significant if the largest p-value is \<0·05.|Mixed Models Analysis|||||0.078|-0.118|0.69
70901025|NCT03243422|141290860|SUPERIORITY||Slope|0.017||||0.7|TWO_SIDED|95.0|-0.07|0.104||Secondary outcomes were evaluated with Hochberg modification to the Bonferroni adjustment estimates are considered statistically significant if the largest p-value is \<0·05.|Mixed Models Analysis|||||0.104|-0.070|0.70
70901026|NCT03243422|141290861|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.59|TWO_SIDED|95.0|0.61|1.33||Secondary outcomes were evaluated with Hochberg modification to the Bonferroni adjustment estimates are considered statistically significant if the largest p-value is \<0·05.|Regression, Cox|Discrete-time interval model||||1.33|0.61|0.59
70901027|NCT03243422|141290862|SUPERIORITY||Slope|0.191||||0.027|TWO_SIDED|95.0|0.022|0.36|||Mixed Models Analysis|||Analysis was restricted to ARIC participants who were enrolled in ACHIEVE||0.360|0.022|0.027
70901028|NCT03243422|141290863|SUPERIORITY||Slope|-0.061||||0.18|TWO_SIDED|95.0|-0.151|0.028|||Mixed Models Analysis|||||0.028|-0.151|0.18
70901029|NCT02466646|141290877|OTHER||Mean Difference (Net)|0.3|||<|0.01|TWO_SIDED|||||The threshold for statistical significance was p=0.05|Kruskal-Wallis|||||||<0.01
70901030|NCT02466646|141290878|OTHER||Mean Difference (Net)|2.0|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was P=0.05|Kruskal-Wallis|||||||>0.05
70901031|NCT02466646|141290879|OTHER|||||||0.229||||||Threshold for statistical significance is p=0.05.|Kruskal-Wallis|||||||0.229
70901032|NCT02466646|141290880|OTHER|||||||0.28||||||Threshold for statistical significance is p=0.05.|Kruskal-Wallis|||||||0.280
70901033|NCT02466646|141290881|OTHER|||||||0.712|||||||Kruskal-Wallis|Threshold for statistical significance is p=0.05.||||||0.712
70901034|NCT02466646|141290882|OTHER|||||||0.674||||||The threshold for statistical significance is p=0.05.|Kruskal-Wallis|||||||0.674
70901035|NCT02466646|141290883|OTHER||Mean Difference (Net)|30.0||||0.006|TWO_SIDED|||||The threshold for statistical significance was p=0.05|Kruskal-Wallis|||||||0.006
70901036|NCT02466646|141290884|OTHER||Mean Difference (Net)|0.5||||0.373|TWO_SIDED||||||Kruskal-Wallis|||||||0.373
70901037|NCT02466646|141290885|OTHER||Mean Difference (Net)|0.6||||0.528|TWO_SIDED||||||Kruskal-Wallis|||||||0.528
70901038|NCT02466646|141290886|OTHER||Mean Difference (Net)|1.0||||0.208|TWO_SIDED||||||Kruskal-Wallis|||||||0.208
70901039|NCT02466646|141290887|OTHER|||||||0.051|||||||Kruskal-Wallis|||||||0.051
70901040|NCT02466646|141290888|OTHER|||||||0.647||||||The threshold for statistical significance is p=0.05.|Kruskal-Wallis|||||||0.647
70901041|NCT03261271|141290889|SUPERIORITY|||||||0.6489||||||P value less than 0.05 was considered statistically significant.|Mixed Models Analysis|||||||0.6489
70901042|NCT03261271|141290890|SUPERIORITY|||||||0.0323|||||||Mixed Models Analysis|||||||0.0323
70901043|NCT03261271|141290891|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
70901044|NCT03261271|141290892|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
70901045|NCT03261271|141290893|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||Difference between groups from Baseline to Study End.||||0.09
70901046|NCT03261271|141290893|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||Difference between groups from baseline to pre-surgery.||||0.04
70901047|NCT02173054|141290894|SUPERIORITY_OR_OTHER|||||||0.001||||||This statistical analysis was used to compare number of participants who had erythema among 3 groups.|Kruskal-Wallis|||||||0.001
70901048|NCT02173054|141290894|SUPERIORITY_OR_OTHER|||||||0.016||||||This statistical analysis was used to compare number of participants who had dryness among 3 groups|Kruskal-Wallis|||||||0.016
70901049|NCT02173054|141290894|SUPERIORITY_OR_OTHER|||||||0.025||||||This statistical analysis was used to compare number of participants who had scaling among 3 groups.|Kruskal-Wallis|||||||0.025
70901050|NCT02173054|141290894|SUPERIORITY_OR_OTHER|||||||0.571||||||This statistical analysis was used to compare number of participants who had stinging among 3 groups.|Kruskal-Wallis|||||||0.571
70901051|NCT02173054|141290894|SUPERIORITY_OR_OTHER|||||||0.449||||||This statistical analysis was used to compare number of participants who had pruritus among 3 groups.|Kruskal-Wallis|||||||0.449
70901052|NCT02173054|141290895|SUPERIORITY_OR_OTHER|||||||0.059||||||This statistical analysis was used to evaluate the change in total lesion counts at baseline and 8th week|wilcoxan signed ranks test|||||||0.059
70901053|NCT02173054|141290895|SUPERIORITY_OR_OTHER|||||||0.697||||||This statistical analysis was used to evaluate the change in total lesion counts at baseline and 8th week|wilcoxan signed ranks test|||||||0.697
70901054|NCT02173054|141290895|SUPERIORITY_OR_OTHER|||||||0.028||||||This statistical analysis was used to evaluate the change in total lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.028
70901055|NCT02173054|141290895|SUPERIORITY_OR_OTHER|||||||0.001||||||This statistical analysis was used to evaluate the change in inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.001
70901056|NCT02173054|141290895|SUPERIORITY_OR_OTHER|||||||0.755||||||This statistical analysis was used to evaluate the change in inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.755
70901057|NCT02173054|141290895|SUPERIORITY_OR_OTHER|||||||0.003||||||This statistical analysis was used to evaluate the change in inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.003
70901058|NCT02173054|141290895|SUPERIORITY_OR_OTHER|||||||0.205||||||This statistical analysis was used to evaluate the change in non inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.205
70901059|NCT02173054|141290895|SUPERIORITY_OR_OTHER|||||||0.576||||||This statistical analysis was used to evaluate the change in non inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.576
70901060|NCT02173054|141290895|SUPERIORITY_OR_OTHER|||||||0.16||||||This statistical analysis was used to evaluate the change in non inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.160
70901061|NCT02173054|141290896|SUPERIORITY_OR_OTHER|||||||0.078||||||This statistical analysis was used to evaluate the change in skin sebum content at baseline and 8th week of the Adapalene gel group|Paired t-test|||||||0.078
70901062|NCT02173054|141290896|SUPERIORITY_OR_OTHER|||||||0.167||||||This statistical analysis was used to evaluate the change in skin sebum content at baseline and 8th week of the Adapalene gel with placebo moisturizer group|Paired t-test|||||||0.167
70901063|NCT02173054|141290896|SUPERIORITY_OR_OTHER|||||||0.134||||||This statistical analysis was used to evaluate the change in skin sebum content at baseline and 8th week of the Adapalene gel with Eucerin group|Paired t-test|||||||0.134
70901064|NCT02173054|141290896|SUPERIORITY_OR_OTHER|||||||0.978||||||This statistical analysis was used to evaluate the change in skin hydration at baseline and 8th week of the Adapalene gel group|Paired t-test|||||||0.978
70901065|NCT02173054|141290896|SUPERIORITY_OR_OTHER|||||||0.273||||||This statistical analysis was used to evaluate the change in skin hydration at baseline and 8th week of the Adapalene gel with placebo moisturizer group|Paired t-test|||||||0.273
70901066|NCT02173054|141290896|SUPERIORITY_OR_OTHER|||||||0.735||||||This statistical analysis was used to evaluate the change in skin hydration at baseline and 8th week of the Adapalene gel with Eucerin group.|Paired t-test|||||||0.735
70901067|NCT02173054|141290897|SUPERIORITY_OR_OTHER|||||||0.0002||||||This statistical analysis was used to evaluate the change in TEWL at baseline and 8th week of the Adapalene gel group.|Paired t-test|||||||0.0002
70901068|NCT02173054|141290897|SUPERIORITY_OR_OTHER|||||||0.007||||||This statistical analysis was used to evaluate the change in TEWL at baseline and 8th week of the Adapalene gel with placebo moisturizer group.|Paired t-test|||||||0.007
70901069|NCT02173054|141290897|SUPERIORITY_OR_OTHER|||||||0.123||||||This statistical analysis was used to evaluate the change in TEWL at baseline and 8th week of the Adapalene gel with Eucerin group.|Paired t-test|||||||0.123
70901070|NCT02173054|141290898|SUPERIORITY_OR_OTHER|||||||0.005||||||This statistical analysis was used to evaluate the change in ASI score at baseline and 8th week.|wilcoxan signed ranks test|||||||0.005
70901071|NCT02173054|141290898|SUPERIORITY_OR_OTHER|||||||0.606||||||This statistical analysis was used to evaluate the change in ASI score at baseline and 8th week.|wilcoxan signed ranks test|||||||0.606
70901072|NCT02173054|141290898|SUPERIORITY_OR_OTHER|||||||0.001||||||This statistical analysis was used to evaluate the change in ASI score at baseline and 8th week.|wilcoxan signed ranks test|||||||0.001
70901073|NCT01083654|141290899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.262|TWO_SIDED|95.0|0.2|1.55|||Regression, Logistic|||||1.55|0.20|.262
70901074|NCT01559454|141290900|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|35.4167||||0.097|TWO_SIDED|95.0|-8.7519|79.5852|||t-test, 2 sided|||||79.5852|-8.7519|0.097
70901075|NCT01559454|141290901|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.5||||1|TWO_SIDED|95.0|0.0713|1.8248|||Fisher Exact|||||1.8248|0.0713|1.00
70901076|NCT01559454|141290902|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.55075||||0.348|TWO_SIDED|95.0|-20.37051|51.34968|||t-test, 2 sided|||||51.34968|-20.37051|0.348
70901077|NCT01559454|141290903|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|39.5833||||0.088|TWO_SIDED|95.0|-7.9653|87.132|||t-test, 2 sided|||||87.1320|-7.9653|0.088
70901078|NCT01559454|141290904|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.1499||||0.895|TWO_SIDED|95.0|-30.3965|27.0632|||t-test, 2 sided|||||27.0632|-30.3965|0.895
70901079|NCT01559454|141290905|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.6||||0.6999|TWO_SIDED|95.0|0.127|2.8352|||Fisher Exact|||||2.8352|0.127|0.6999
70901080|NCT01114204|141290906|NON_INFERIORITY|The 95% confidence interval (CI) was calculated using the large sample assumption. The pre-defined non-inferiority margin for testing the difference between treatment groups was -15%.|Treatment Difference|2.58||||0.2833|TWO_SIDED|95.0|-3.89|9.06|||Cochran-Mantel-Haenszel|The p-value is the result of the Cochran-Mantel-Haenszel test, adjusted for Baseline hemoglobin level and underlying condition.|The treatment difference (ferumoxytol - iron sucrose) was expressed as a percentage.|"Participants who achieved a ≥2.0 g/dL increase in hemoglobin from Baseline up to Week 5 were analyzed. Statistical comparison was performed for data up to Week 5 only.~Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information."||9.06|-3.89|0.2833
70901081|NCT00215540|141290946|SUPERIORITY_OR_OTHER|||||||0.476||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||Null hypothesis: No difference between treatment groups||||0.476
70901082|NCT00215540|141290946|SUPERIORITY_OR_OTHER|||||||0.208||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||Null hypothesis: No difference between treatment groups||||0.208
70901083|NCT00215540|141290947|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||Null hypothesis: No difference between treatment groups||||0.500
70901084|NCT00215540|141290947|SUPERIORITY_OR_OTHER|||||||0.146||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||Null hypothesis: No difference between treatment groups||||0.146
70901085|NCT00215540|141290948|SUPERIORITY_OR_OTHER|||||||0.267||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.267
70901086|NCT00215540|141290948|SUPERIORITY_OR_OTHER|||||||0.313||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.313
70901087|NCT00215540|141290948|SUPERIORITY_OR_OTHER|||||||0.944||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.944
70901088|NCT00215540|141290949|SUPERIORITY_OR_OTHER|||||||0.476||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.476
70901089|NCT00215540|141290949|SUPERIORITY_OR_OTHER|||||||0.208||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.208
70901090|NCT00215540|141290949|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.046
70901091|NCT00215540|141290950|SUPERIORITY_OR_OTHER|||||||0.285||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.285
70901092|NCT00215540|141290950|SUPERIORITY_OR_OTHER|||||||0.229||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.229
70901093|NCT00215540|141290950|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.030
70901094|NCT00215540|141290951|SUPERIORITY_OR_OTHER|||||||0.483||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.483
70901095|NCT00215540|141290951|SUPERIORITY_OR_OTHER|||||||0.123||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.123
70901096|NCT00215540|141290951|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.006
70901097|NCT00215540|141290952|SUPERIORITY_OR_OTHER|||||||0.843||95.0|||||ANOVA|Adjusting for pooled study center||||||0.843
70901098|NCT00215540|141290952|SUPERIORITY_OR_OTHER|||||||0.543||95.0|||||ANOVA|Adjusting for pooled study center||||||0.543
70901099|NCT00215540|141290952|SUPERIORITY_OR_OTHER|||||||0.537||95.0|||||ANOVA|Adjusting for pooled study center||||||0.537
70901100|NCT00215540|141290953|SUPERIORITY_OR_OTHER|||||||0.813||95.0|||||ANOVA|Adjusting for pooled study center||||||0.813
70901101|NCT00215540|141290953|SUPERIORITY_OR_OTHER|||||||0.449||95.0|||||ANOVA|Adjusting for pooled study center||||||0.449
70901102|NCT00215540|141290953|SUPERIORITY_OR_OTHER|||||||0.275||95.0|||||ANOVA|Adjusting for pooled study center||||||0.275
70901103|NCT00215540|141290954|SUPERIORITY_OR_OTHER|||||||0.267||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.267
70901104|NCT00215540|141290954|SUPERIORITY_OR_OTHER|||||||0.313||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.313
70901105|NCT00215540|141290955|SUPERIORITY_OR_OTHER|||||||0.311||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.311
70901106|NCT00215540|141290955|SUPERIORITY_OR_OTHER|||||||0.516||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.516
70901107|NCT00215540|141290955|SUPERIORITY_OR_OTHER|||||||0.094||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.094
70901108|NCT02799472|141290973|OTHER||Ratio|14.201|||<|0.001|TWO_SIDED|95.0|6.251|32.262|||Repeated measures analysis|||GM-CSF - Complex, Week 1||32.262|6.251|<0.001
70901109|NCT02799472|141290973|OTHER||Ratio|32.36|||<|0.001|TWO_SIDED|95.0|15.828|66.156|||Repeated measures analysis|||GM-CSF - Complex, Week 2||66.156|15.828|<0.001
70901110|NCT02799472|141290973|OTHER||Ratio|55.772|||<|0.001|TWO_SIDED|95.0|25.646|121.287|||Repeated measures analysis|||GM-CSF - Complex, Week 4||121.287|25.646|<0.001
70901111|NCT02799472|141290973|OTHER||Ratio|48.336|||<|0.001|TWO_SIDED|95.0|19.341|120.798|||Repeated measures analysis|||GM-CSF - Complex, Week 6||120.798|19.341|<0.001
70901112|NCT02799472|141290973|OTHER||Ratio|34.635|||<|0.001|TWO_SIDED|95.0|13.69|87.629|||Repeated measures analysis|||GM-CSF - Complex, Week 8||87.629|13.690|<0.001
70901113|NCT02799472|141290973|OTHER||Ratio|23.249|||<|0.001|TWO_SIDED|95.0|8.579|63.005|||Repeated measures analysis|||GM-CSF - Complex, Week 12||63.005|8.579|<0.001
70901114|NCT02799472|141290973|OTHER||Ratio|1.233||||0.401|TWO_SIDED|95.0|0.742|2.048|||Repeated measures analysis|||GM-CSF - Complex, 12-Week FU||2.048|0.742|0.401
70901115|NCT02799472|141290974|OTHER||Ratio|0.943||||0.193|TWO_SIDED|95.0|0.861|1.032|||Repeated measures analysis|||14-3-3 ETA Protein, Week 1||1.032|0.861|0.193
70901116|NCT02799472|141290974|OTHER||Ratio|1.028||||0.842|TWO_SIDED|95.0|0.776|1.362|||Repeated measures analysis|||14-3-3 ETA Protein, Week 2||1.362|0.776|0.842
70901117|NCT02799472|141290974|OTHER||Ratio|0.743||||0.127|TWO_SIDED|95.0|0.505|1.093|||Repeated measures analysis|||14-3-3 ETA Protein, Week 4||1.093|0.505|0.127
70901118|NCT02799472|141290974|OTHER||Ratio|0.762||||0.137|TWO_SIDED|95.0|0.531|1.095|||Repeated measures analysis|||14-3-3 ETA Protein, Week 6||1.095|0.531|0.137
70901119|NCT02799472|141290974|OTHER||Ratio|0.886||||0.488|TWO_SIDED|95.0|0.623|1.259|||Repeated measures analysis|||14-3-3 ETA Protein, Week 8||1.259|0.623|0.488
70901120|NCT02799472|141290974|OTHER||Ratio|0.793||||0.338|TWO_SIDED|95.0|0.488|1.29|||Repeated measures analysis|||14-3-3 ETA Protein, Week 12||1.290|0.488|0.338
70901121|NCT02799472|141290974|OTHER||Ratio|0.859||||0.582|TWO_SIDED|95.0|0.491|1.502|||Repeated measures analysis|||14-3-3 ETA Protein, 12-Week FU||1.502|0.491|0.582
70901122|NCT02799472|141290974|OTHER||Ratio|0.999||||0.996|TWO_SIDED|95.0|0.699|1.427|||Repeated measures analysis|||S100 CBP A8 and A9, Week 1||1.427|0.699|0.996
70901123|NCT02799472|141290974|OTHER||Ratio|0.944||||0.745|TWO_SIDED|95.0|0.662|1.346|||Repeated measures analysis|||S100 CBP A8 and A9, Week 2||1.346|0.662|0.745
70901124|NCT02799472|141290974|OTHER||Ratio|1.017||||0.939|TWO_SIDED|95.0|0.649|1.593|||Repeated measures analysis|||S100 CBP A8 and A9, Week 4||1.593|0.649|0.939
70901125|NCT02799472|141290974|OTHER||Ratio|0.981||||0.937|TWO_SIDED|95.0|0.595|1.617|||Repeated measures analysis|||S100 CBP A8 and A9, Week 6||1.617|0.595|0.937
70901126|NCT02799472|141290974|OTHER||Ratio|1.067||||0.787|TWO_SIDED|95.0|0.659|1.727|||Repeated measures analysis|||S100 CBP A8 and A9, Week 8||1.727|0.659|0.787
70901127|NCT02799472|141290974|OTHER||Ratio|1.267||||0.342|TWO_SIDED|95.0|0.769|2.086|||Repeated measures analysis|||S100 CBP A8 and A9, Week 12||2.086|0.769|0.342
70901128|NCT02799472|141290974|OTHER||Ratio|1.748||||0.026|TWO_SIDED|95.0|1.076|2.838|||Repeated measures analysis|||S100 CBP A8 and A9, 12-Week FU||2.838|1.076|0.026
70901129|NCT02799472|141290975|OTHER||Ratio|0.774||||0.632|TWO_SIDED|95.0|0.261|2.29|||Repeated measures analysis|||Amyloid A, Week 12||2.290|0.261|0.632
70901130|NCT02799472|141290975|OTHER||Ratio|1.176||||0.685|TWO_SIDED|95.0|0.519|2.663|||Repeated measures analysis|||Amyloid A, 12-Week FU||2.663|0.519|0.685
70901131|NCT02799472|141290976|OTHER||Ratio|0.692||||0.097|TWO_SIDED|95.0|0.445|1.074|||Repeated measures analysis|||CL17, Week 1||1.074|0.445|0.097
70901132|NCT02799472|141290976|OTHER||Ratio|0.713||||0.229|TWO_SIDED|95.0|0.407|1.249|||Repeated measures analysis|||CL17, Week 2||1.249|0.407|0.229
70901133|NCT02799472|141290976|OTHER||Ratio|0.608||||0.055|TWO_SIDED|95.0|0.365|1.012|||Repeated measures analysis|||CL17, Week 4||1.012|0.365|0.055
70901134|NCT02799472|141290976|OTHER||Ratio|0.755||||0.307|TWO_SIDED|95.0|0.435|1.309|||Repeated measures analysis|||CL17, Week 6||1.309|0.435|0.307
70901135|NCT02799472|141290976|OTHER||Ratio|0.557||||0.017|TWO_SIDED|95.0|0.348|0.894|||Repeated measures analysis|||CL17, Week 8||0.894|0.348|0.017
70901136|NCT02799472|141290976|OTHER||Ratio|0.52||||0.026|TWO_SIDED|95.0|0.294|0.922|||Repeated measures analysis|||||0.922|0.294|0.026
70901137|NCT02799472|141290976|OTHER||Ratio|0.947||||0.839|TWO_SIDED|95.0|0.548|1.636|||Repeated measures analysis|||CL17, 12-Week FU||1.636|0.548|0.839
70901138|NCT02799472|141290976|OTHER||Ratio|0.764||||0.142|TWO_SIDED|95.0|0.53|1.1|||Repeated measures analysis|||CL13, Week 1||1.100|0.530|0.142
70901139|NCT02799472|141290976|OTHER||Ratio|1.005||||0.976|TWO_SIDED|95.0|0.726|1.39|||Repeated measures analysis|||CL13, Week 2||1.390|0.726|0.976
70901140|NCT02799472|141290976|OTHER||Ratio|1.236||||0.244|TWO_SIDED|95.0|0.859|1.778|||Repeated measures analysis|||CL13, Week 4||1.778|0.859|0.244
70901141|NCT02799472|141290976|OTHER||Ratio|1.237||||0.278|TWO_SIDED|95.0|0.836|1.83|||Repeated measures analysis|||CL13, Week 6||1.830|0.836|0.278
70901142|NCT02799472|141290976|OTHER||Ratio|1.118||||0.677|TWO_SIDED|95.0|0.651|1.92|||Repeated measures analysis|||CL13, Week 8||1.920|0.651|0.677
70901143|NCT02799472|141290976|OTHER||Ratio|1.165||||0.661|TWO_SIDED|95.0|0.573|2.369|||Repeated measures analysis|||CL13, Week 12||2.369|0.573|0.661
70901144|NCT02799472|141290976|OTHER||Ratio|1.581||||0.154|TWO_SIDED|95.0|0.832|3.007|||Repeated measures analysis|||CL13, 12-Week FU||3.007|0.832|0.154
70901145|NCT02799472|141290976|OTHER||Ratio|0.903||||0.751|TWO_SIDED|95.0|0.471|1.729|||Repeated measures analysis|||Interleukin 6, Week 1||1.729|0.471|0.751
70901146|NCT02799472|141290976|OTHER||Ratio|0.72||||0.33|TWO_SIDED|95.0|0.367|1.413|||Repeated measures analysis|||Interleukin 6, Week 2||1.413|0.367|0.330
70901147|NCT02799472|141290976|OTHER||Ratio|0.822||||0.519|TWO_SIDED|95.0|0.447|1.512|||Repeated measures analysis|||Interleukin 6, Week 4||1.512|0.447|0.519
70901148|NCT02799472|141290976|OTHER||Ratio|0.659||||0.147|TWO_SIDED|95.0|0.372|1.167|||Repeated measures analysis|||Interleukin 6, Week 6||1.167|0.372|0.147
70901149|NCT02799472|141290976|OTHER||Ratio|0.684||||0.166|TWO_SIDED|95.0|0.396|1.18|||Repeated measures analysis|||Interleukin 6, Week 8||1.180|0.396|0.166
70901150|NCT02799472|141290976|OTHER||Ratio|1.221||||0.432|TWO_SIDED|95.0|0.734|2.031|||Repeated measures analysis|||Interleukin 6, Week 12||2.031|0.734|0.432
70901151|NCT02799472|141290976|OTHER||Ratio|1.602||||0.216|TWO_SIDED|95.0|0.75|3.423|||Repeated measures analysis|||Interleukin 6, 12-Week FU||3.423|0.750|0.216
70901152|NCT02799472|141290976|OTHER||Ratio|0.926||||0.195|TWO_SIDED|95.0|0.823|1.042|||Repeated measures analysis|||MDC, Week 1||1.042|0.823|0.195
70901153|NCT02799472|141290976|OTHER||Ratio|0.984||||0.851|TWO_SIDED|95.0|0.829|1.168|||Repeated measures analysis|||MDC, Week 2||1.168|0.829|0.851
70901154|NCT02799472|141290976|OTHER||Ratio|0.956||||0.637|TWO_SIDED|95.0|0.79|1.158|||Repeated measures analysis|||MDC, Week 4||1.158|0.790|0.637
70901155|NCT02799472|141290976|OTHER||Ratio|1.01||||0.915|TWO_SIDED|95.0|0.833|1.225|||Repeated measures analysis|||MDC, Week 6||1.225|0.833|0.915
70901156|NCT02799472|141290976|OTHER||Ratio|0.857||||0.157|TWO_SIDED|95.0|0.69|1.064|||Repeated measures analysis|||MDC, Week 8||1.064|0.690|0.157
70901157|NCT02799472|141290976|OTHER||Ratio|0.849||||0.142|TWO_SIDED|95.0|0.681|1.059|||Repeated measures analysis|||MDC, Week 12||1.059|0.681|0.142
70901158|NCT02799472|141290976|OTHER||Ratio|1.013||||0.929|TWO_SIDED|95.0|0.745|1.378|||Repeated measures analysis|||MDC, 12-Week FU||1.378|0.745|0.929
70901159|NCT02799472|141290977|OTHER||Ratio|0.887||||0.463|TWO_SIDED|95.0|0.64|1.231|||Repeated measures analysis|||Chitinase 3 Like 1, Week 1||1.231|0.640|0.463
70901160|NCT02799472|141290977|OTHER||Ratio|0.953||||0.782|TWO_SIDED|95.0|0.672|1.352|||Repeated measures analysis|||Chitinase 3 Like 1, Week 2||1.352|0.672|0.782
70901161|NCT02799472|141290977|OTHER||Ratio|1.132||||0.533|TWO_SIDED|95.0|0.759|1.69|||Repeated measures analysis|||Chitinase 3 Like 1, Week 4||1.690|0.759|0.533
70901162|NCT02799472|141290977|OTHER||Ratio|1.149||||0.473|TWO_SIDED|95.0|0.779|1.694|||Repeated measures analysis|||Chitinase 3 Like 1, Week 6||1.694|0.779|0.473
70901163|NCT02799472|141290977|OTHER||Ratio|1.112||||0.608|TWO_SIDED|95.0|0.733|1.687|||Repeated measures analysis|||Chitinase 3 Like 1, Week 8||1.687|0.733|0.608
70901164|NCT02799472|141290977|OTHER||Ratio|1.005||||0.985|TWO_SIDED|95.0|0.613|1.645|||Repeated measures analysis|||Chitinase 3 Like 1, Week 12||1.645|0.613|0.985
70901165|NCT02799472|141290977|OTHER||Ratio|1.386||||0.102|TWO_SIDED|95.0|0.934|2.057|||Repeated measures analysis|||Chitinase 3 Like 1, 12-Week FU||2.057|0.934|0.102
70901166|NCT02799472|141290977|OTHER||Ratio|0.915||||0.259|TWO_SIDED|95.0|0.781|1.071|||Repeated measures analysis|||MMP-3, Week 1||1.071|0.781|0.259
70901167|NCT02799472|141290977|OTHER||Ratio|0.959||||0.621|TWO_SIDED|95.0|0.809|1.137|||Repeated measures analysis|||MMP-3, Week 2||1.137|0.809|0.621
70901168|NCT02799472|141290977|OTHER||Ratio|0.914||||0.354|TWO_SIDED|95.0|0.752|1.11|||Repeated measures analysis|||MMP-3, Week 4||1.110|0.752|0.354
70901169|NCT02799472|141290977|OTHER||Ratio|0.8||||0.448|TWO_SIDED|95.0|0.443|1.444|||Repeated measures analysis|||MMP-3, Week 6||1.444|0.443|0.448
70901170|NCT02799472|141290977|OTHER||Ratio|1.16||||0.402|TWO_SIDED|95.0|0.813|1.653|||Repeated measures analysis|||MMP-3, Week 8||1.653|0.813|0.402
70901171|NCT02799472|141290977|OTHER||Ratio|0.951||||0.745|TWO_SIDED|95.0|0.695|1.301|||Repeated measures analysis|||MMP-3, Week 12||1.301|0.695|0.745
70901172|NCT02799472|141290977|OTHER||Ratio|1.226||||0.279|TWO_SIDED|95.0|0.837|1.796|||Repeated measures analysis|||MMP-3, 12-Week FU||1.796|0.837|0.279
70901173|NCT02799472|141290978|OTHER||Ratio|1.098||||0.621|TWO_SIDED|95.0|0.75|1.606|||Repeated measures analysis|||ARGS Neo-Epitope, Week 1||1.606|0.750|0.621
70901174|NCT02799472|141290978|OTHER||Ratio|1.581||||0.031|TWO_SIDED|95.0|1.046|2.388|||Repeated measures analysis|||ARGS Neo-Epitope, Week 2||2.388|1.046|0.031
70901175|NCT02799472|141290978|OTHER||Ratio|1.222||||0.317|TWO_SIDED|95.0|0.817|1.827|||Repeated measures analysis|||ARGS Neo-Epitope, Week 4||1.827|0.817|0.317
70901176|NCT02799472|141290978|OTHER||Ratio|1.302||||0.113|TWO_SIDED|95.0|0.936|1.81|||Repeated measures analysis|||ARGS Neo-Epitope, Week 6||1.810|0.936|0.113
70901177|NCT02799472|141290978|OTHER||Ratio|1.45||||0.217|TWO_SIDED|95.0|0.795|2.645|||Repeated measures analysis|||ARGS Neo-Epitope, Week 8||2.645|0.795|0.217
70901178|NCT02799472|141290978|OTHER||Ratio|1.266||||0.147|TWO_SIDED|95.0|0.916|1.75|||Repeated measures analysis|||ARGS Neo-Epitope, Week 12||1.750|0.916|0.147
70901179|NCT02799472|141290978|OTHER||Ratio|0.996||||0.985|TWO_SIDED|95.0|0.662|1.499|||Repeated measures analysis|||ARGS Neo-Epitope, 12-Week FU||1.499|0.662|0.985
70901180|NCT02799472|141290978|OTHER||Ratio|0.892||||0.681|TWO_SIDED|95.0|0.511|1.56|||Repeated measures analysis|||CMDV, Week 1||1.560|0.511|0.681
70901181|NCT02799472|141290978|OTHER||Ratio|0.87||||0.668|TWO_SIDED|95.0|0.454|1.669|||Repeated measures analysis|||CMDV, Week 2||1.669|0.454|0.668
70901182|NCT02799472|141290978|OTHER||Ratio|1.12||||0.717|TWO_SIDED|95.0|0.597|2.101|||Repeated measures analysis|||CMDV, Week 4||2.101|0.597|0.717
70901183|NCT02799472|141290978|OTHER||Ratio|0.661||||0.227|TWO_SIDED|95.0|0.333|1.31|||Repeated measures analysis|||CMDV, Week 6||1.310|0.333|0.227
70901184|NCT02799472|141290978|OTHER||Ratio|0.817||||0.471|TWO_SIDED|95.0|0.464|1.437|||Repeated measures analysis|||CMDV, Week 8||1.437|0.464|0.471
70901185|NCT02799472|141290978|OTHER||Ratio|0.816||||0.541|TWO_SIDED|95.0|0.417|1.597|||Repeated measures analysis|||CMDV, Week 12||1.597|0.417|0.541
70901186|NCT02799472|141290978|OTHER||Ratio|0.822||||0.544|TWO_SIDED|95.0|0.422|1.602|||Repeated measures analysis|||CMDV, 12-Week FU||1.602|0.422|0.544
70901187|NCT02799472|141290978|OTHER||Ratio|1.051||||0.537|TWO_SIDED|95.0|0.895|1.233|||Repeated measures analysis|||MMP-Degraded CRP, Week 1||1.233|0.895|0.537
70901188|NCT02799472|141290978|OTHER||Ratio|1.031||||0.635|TWO_SIDED|95.0|0.906|1.173|||Repeated measures analysis|||MMP-Degraded CRP, Week 2||1.173|0.906|0.635
70901189|NCT02799472|141290978|OTHER||Ratio|1.012||||0.866|TWO_SIDED|95.0|0.879|1.165|||Repeated measures analysis|||MMP-Degraded CRP, Week 4||1.165|0.879|0.866
70901190|NCT02799472|141290978|OTHER||Ratio|0.979||||0.78|TWO_SIDED|95.0|0.842|1.139|||Repeated measures analysis|||MMP-Degraded CRP, Week 6||1.139|0.842|0.780
70901191|NCT02799472|141290978|OTHER||Ratio|1.113||||0.212|TWO_SIDED|95.0|0.938|1.32|||Repeated measures analysis|||MMP-Degraded CRP, Week 8||1.320|0.938|0.212
70901192|NCT02799472|141290978|OTHER||Ratio|1.102||||0.242|TWO_SIDED|95.0|0.934|1.3|||Repeated measures analysis|||MMP-Degraded CRP, Week 12||1.300|0.934|0.242
70901193|NCT02799472|141290978|OTHER||Ratio|1.05||||0.597|TWO_SIDED|95.0|0.87|1.267|||Repeated measures analysis|||MMP-Degraded CRP, 12-Week FU||1.267|0.870|0.597
70901194|NCT02799472|141290978|OTHER||Ratio|0.795||||0.047|TWO_SIDED|95.0|0.634|0.997|||Repeated measures analysis|||MD1C, Week 1||0.997|0.634|0.047
70901195|NCT02799472|141290978|OTHER||Ratio|0.883||||0.367|TWO_SIDED|95.0|0.668|1.165|||Repeated measures analysis|||MD1C, Week 2||1.165|0.668|0.367
70901196|NCT02799472|141290978|OTHER||Ratio|0.784||||0.155|TWO_SIDED|95.0|0.558|1.102|||Repeated measures analysis|||MD1C, Week 4||1.102|0.558|0.155
70901197|NCT02799472|141290978|OTHER||Ratio|0.638||||0.004|TWO_SIDED|95.0|0.477|0.855|||Repeated measures analysis|||MD1C, Week 6||0.855|0.477|0.004
70901198|NCT02799472|141290978|OTHER||Ratio|0.799||||0.14|TWO_SIDED|95.0|0.591|1.08|||Repeated measures analysis|||MD1C, Week 8||1.080|0.591|0.140
70901199|NCT02799472|141290978|OTHER||Ratio|0.891||||0.47|TWO_SIDED|95.0|0.647|1.228|||Repeated measures analysis|||MD1C, Week 12||1.228|0.647|0.470
70901200|NCT02799472|141290978|OTHER||Ratio|0.869||||0.401|TWO_SIDED|95.0|0.621|1.217|||Repeated measures analysis|||MD1C, 12-Week FU||1.217|0.621|0.401
70901201|NCT02799472|141290978|OTHER||Ratio|0.981||||0.887|TWO_SIDED|95.0|0.742|1.296|||Repeated measures analysis|||MD2C, Week 1||1.296|0.742|0.887
70901202|NCT02799472|141290978|OTHER||Ratio|0.97||||0.814|TWO_SIDED|95.0|0.744|1.263|||Repeated measures analysis|||MD2C, Week 2||1.263|0.744|0.814
70901203|NCT02799472|141290978|OTHER||Ratio|0.969||||0.794|TWO_SIDED|95.0|0.762|1.233|||Repeated measures analysis|||MD2C, Week 4||1.233|0.762|0.794
70901204|NCT02799472|141290978|OTHER||Ratio|0.919||||0.539|TWO_SIDED|95.0|0.696|1.213|||Repeated measures analysis|||MD2C, Week 6||1.213|0.696|0.539
70901205|NCT02799472|141290978|OTHER||Ratio|0.937||||0.623|TWO_SIDED|95.0|0.719|1.221|||Repeated measures analysis|||MD2C, Week 8||1.221|0.719|0.623
70901206|NCT02799472|141290978|OTHER||Ratio|0.913||||0.467|TWO_SIDED|95.0|0.711|1.173|||Repeated measures analysis|||MD2C, Week 12||1.173|0.711|0.467
70901207|NCT02799472|141290978|OTHER||Ratio|0.778||||0.108|TWO_SIDED|95.0|0.57|1.061|||Repeated measures analysis|||MD2C, 12-Week FU||1.061|0.570|0.108
70901208|NCT02799472|141290978|OTHER||Ratio|1.01||||0.897|TWO_SIDED|95.0|0.868|1.175|||Repeated measures analysis|||MD3C, Week 1||1.175|0.868|0.897
70901209|NCT02799472|141290978|OTHER||Ratio|1.037||||0.644|TWO_SIDED|95.0|0.884|1.218|||Repeated measures analysis|||MD3C, Week 2||1.218|0.884|0.644
70901210|NCT02799472|141290978|OTHER||Ratio|0.943||||0.53|TWO_SIDED|95.0|0.78|1.139|||Repeated measures analysis|||MD3C, Week 4||1.139|0.780|0.530
70901211|NCT02799472|141290978|OTHER||Ratio|0.882||||0.182|TWO_SIDED|95.0|0.733|1.063|||Repeated measures analysis|||MD3C, Week 6||1.063|0.733|0.182
70901212|NCT02799472|141290978|OTHER||Ratio|0.96||||0.691|TWO_SIDED|10.0|0.779|1.182|||Repeated measures analysis|||MD3C, Week 8||1.182|0.779|0.691
70901213|NCT02799472|141290978|OTHER||Ratio|0.979||||0.843|TWO_SIDED|95.0|0.79|1.214|||Repeated measures analysis|||MD3C, Week 12||1.214|0.790|0.843
70901214|NCT02799472|141290978|OTHER||Ratio|1.075||||0.524|TWO_SIDED|95.0|0.855|1.351|||Repeated measures analysis|||MD3C, 12-Week FU||1.351|0.855|0.524
70901215|NCT02799472|141290979|OTHER||Ratio|0.953||||0.558|TWO_SIDED|95.0|0.809|1.123|||Repeated measures analysis|||Helper/Suppressor, Week 1||1.123|0.809|0.558
70901216|NCT02799472|141290979|OTHER||Ratio|0.947||||0.515|TWO_SIDED|95.0|0.801|1.12|||Repeated measures analysis|||Helper/Suppressor, Week 4||1.120|0.801|0.515
70901217|NCT02799472|141290979|OTHER||Ratio|1.046||||0.565|TWO_SIDED|95.0|0.895|1.222|||Repeated measures analysis|||Helper/Suppressor, Week 12||1.222|0.895|0.565
70901218|NCT02799472|141290979|OTHER||Ratio|1.013||||0.897|TWO_SIDED|95.0|0.822|1.249|||Repeated measures analysis|||Helper/Suppressor, 12-Week FU||1.249|0.822|0.897
70901219|NCT02799472|141290980|OTHER||Ratio|1.037||||0.786|TWO_SIDED|95.0|0.794|1.354|||Repeated measures analysis|||CD16+CD56+, Week 1||1.354|0.794|0.786
70901220|NCT02799472|141290980|OTHER||Ratio|0.818||||0.188|TWO_SIDED|95.0|0.603|1.109|||Repeated measures analysis|||CD16+CD56+, Week 4||1.109|0.603|0.188
70901221|NCT02799472|141290980|OTHER||Ratio|0.763||||0.129|TWO_SIDED|95.0|0.536|1.087|||Repeated measures analysis|||CD16+CD56+, Week 12||1.087|0.536|0.129
70901222|NCT02799472|141290980|OTHER||Ratio|0.709||||0.054|TWO_SIDED|95.0|0.499|1.006|||Repeated measures analysis|||CD16+CD56+, 12-Week FU||1.006|0.499|0.054
70901223|NCT02799472|141290980|OTHER||Ratio|1.119||||0.383|TWO_SIDED|95.0|0.863|1.45|||Repeated measures analysis|||CD19, Week 1||1.450|0.863|0.383
70901224|NCT02799472|141290980|OTHER||Ratio|0.89||||0.51|TWO_SIDED|95.0|0.623|1.271|||Repeated measures analysis|||CD19, Week 4||1.271|0.623|0.510
70901225|NCT02799472|141290980|OTHER||Ratio|0.952||||0.724|TWO_SIDED|95.0|0.718|1.262|||Repeated measures analysis|||CD19, Week 12||1.262|0.718|0.724
70901226|NCT02799472|141290980|OTHER||Ratio|0.958||||0.831|TWO_SIDED|95.0|0.635|1.443|||Repeated measures analysis|||CD19, 12-Week FU||1.443|0.635|0.831
70901227|NCT02799472|141290980|OTHER||Ratio|1.082||||0.437|TWO_SIDED|95.0|0.882|1.328|||Repeated measures analysis|||CD3, Week 1||1.328|0.882|0.437
70901228|NCT02799472|141290980|OTHER||Ratio|0.937||||0.632|TWO_SIDED|95.0|0.711|1.234|||Repeated measures analysis|||CD3, Week 4||1.234|0.711|0.632
70901229|NCT02799472|141290980|OTHER||Ratio|1.088||||0.413|TWO_SIDED|95.0|0.885|1.336|||Repeated measures analysis|||CD3, Week 12||1.336|0.885|0.413
70901230|NCT02799472|141290980|OTHER||Ratio|1.062||||0.567|TWO_SIDED|95.0|0.858|1.316|||Repeated measures analysis|||CD3, 12-Week FU||1.316|0.858|0.567
70901231|NCT02799472|141290980|OTHER||Ratio|1.069||||0.547|TWO_SIDED|95.0|0.855|1.338|||Repeated measures analysis|||CD3+CD4+, Week 1||1.338|0.855|0.547
70901232|NCT02799472|141290980|OTHER||Ratio|0.907||||0.512|TWO_SIDED|95.0|0.673|1.223|||Repeated measures analysis|||CD3+CD4+, Week 4||1.223|0.673|0.512
70901233|NCT02799472|141290980|OTHER||Ratio|1.064||||0.573|TWO_SIDED|95.0|0.853|1.328|||Repeated measures analysis|||CD3+CD4+, Week 12||1.328|0.853|0.573
70901234|NCT02799472|141290980|OTHER||Ratio|1.031||||0.789|TWO_SIDED|95.0|0.818|1.3|||Repeated measures analysis|||CD3+CD4+, 12-Week FU||1.300|0.818|0.789
70901235|NCT02799472|141290981|OTHER||Mean Difference (Net)|0.036||||0.428|TWO_SIDED|95.0|-0.056|0.128|||Repeated measures analysis|||CD3+CD8+, Week 1||0.128|-0.056|0.428
70901236|NCT02799472|141290981|OTHER||Mean Difference (Net)|-0.023||||0.733|TWO_SIDED|95.0|-0.159|0.113|||Repeated measures analysis|||CD3+CD8+, Week 4||0.113|-0.159|0.733
70901237|NCT02799472|141290981|OTHER||Mean Difference (Net)|0.02||||0.677|TWO_SIDED|95.0|-0.076|0.115|||Repeated measures analysis|||CD3+CD8+, Week 12||0.115|-0.076|0.677
70901238|NCT02799472|141290981|OTHER||Mean Difference (Net)|0.033||||0.569|TWO_SIDED|95.0|-0.084|0.151|||Repeated measures analysis|||CD3+CD8+, 12-Week FU||0.151|-0.084|0.569
70901239|NCT02799472|141290981|OTHER||Mean Difference (Net)|0.103||||0.569|TWO_SIDED|95.0|-0.263|0.469|||Repeated measures analysis|||T Cell B Cell NKL, Week 1||0.469|-0.263|0.569
70901240|NCT02799472|141290981|OTHER||Mean Difference (Net)|-0.157||||0.534|TWO_SIDED|95.0|-0.668|0.354|||Repeated measures analysis|||T Cell B Cell NKL, Week 4||0.354|-0.668|0.534
70901241|NCT02799472|141290981|OTHER||Mean Difference (Net)|0.087||||0.668|TWO_SIDED|95.0|-0.323|0.498|||Repeated measures analysis|||T Cell B Cell NKL, Week 12||0.498|-0.323|0.668
70901242|NCT02799472|141290981|OTHER||Mean Difference (Net)|-0.021||||0.934|TWO_SIDED|95.0|-0.526|0.484|||Repeated measures analysis|||T Cell B Cell NKL, 12-Week FU||0.484|-0.526|0.934
70901243|NCT02799472|141290982|OTHER||Ratio|1.112||||0.369|TWO_SIDED|95.0|0.876|1.412|||Repeated measures analysis|||CD3+ CD4+, Week 1||1.412|0.876|0.369
70901244|NCT02799472|141290982|OTHER||Ratio|0.941||||0.641|TWO_SIDED|95.0|0.721|1.228|||Repeated measures analysis|||CD3+ CD4+, Week 4||1.228|0.721|0.641
70901245|NCT02799472|141290982|OTHER||Ratio|1.024||||0.844|TWO_SIDED|95.0|0.804|1.303|||Repeated measures analysis|||CD3+ CD4+, Week 12||1.303|0.804|0.844
70901246|NCT02799472|141290982|OTHER||Ratio|1.082||||0.558|TWO_SIDED|95.0|0.821|1.427|||Repeated measures analysis|||CD3+ CD4+, 12-Week FU||1.427|0.821|0.558
70901247|NCT02799472|141290982|OTHER||Ratio|1.111||||0.363|TWO_SIDED|95.0|0.88|1.402|||Repeated measures analysis|||CD3+ CD8+, Week 1||1.402|0.880|0.363
70901248|NCT02799472|141290982|OTHER||Ratio|0.957||||0.751|TWO_SIDED|95.0|0.724|1.265|||Repeated measures analysis|||CD3+ CD8+, Week 4||1.265|0.724|0.751
70901249|NCT02799472|141290982|OTHER||Ratio|1.076||||0.537|TWO_SIDED|95.0|0.846|1.37|||Repeated measures analysis|||CD3+ CD8+, Week 12||1.370|0.846|0.537
70901250|NCT02799472|141290982|OTHER||Ratio|1.032||||0.806|TWO_SIDED|95.0|0.797|1.335|||Repeated measures analysis|||CD3+ CD8+, 12-Week FU||1.335|0.797|0.806
70901251|NCT02799472|141290982|OTHER||Ratio|1.101||||0.405|TWO_SIDED|95.0|0.872|1.391|||Repeated measures analysis|||CD3+, Week 1||1.391|0.872|0.405
70901252|NCT02799472|141290982|OTHER||Ratio|0.907||||0.519|TWO_SIDED|95.0|0.668|1.232|||Repeated measures analysis|||CD3+, Week 4||1.232|0.668|0.519
70901253|NCT02799472|141290982|OTHER||Ratio|1.036||||0.748|TWO_SIDED|95.0|0.831|1.291|||Repeated measures analysis|||CD3+, Week 12||1.291|0.831|0.748
70901254|NCT02799472|141290982|OTHER||Ratio|1.049||||0.704|TWO_SIDED|95.0|0.811|1.356|||Repeated measures analysis|||CD3+, 12-Week FU||1.356|0.811|0.704
70901255|NCT02799472|141290983|OTHER||Mean Difference (Net)|6.5||||0.501|TWO_SIDED|95.0|-13.1|26.1|||Repeated measures analysis|||CD3+CD4+CD25+CD127-, Week 1||26.1|-13.1|0.501
70901256|NCT02799472|141290983|OTHER||Mean Difference (Net)|-1.8||||0.852|TWO_SIDED|95.0|-21.6|18.0|||Repeated measures analysis|||CD3+CD4+CD25+CD127-, Week 4||18.0|-21.6|0.852
70901257|NCT02799472|141290983|OTHER||Mean Difference (Net)|6.3||||0.572|TWO_SIDED|95.0|-16.4|29.0|||Repeated measures analysis|||CD3+CD4+CD25+CD127-, Week 12||29.0|-16.4|0.572
70901258|NCT02799472|141290983|OTHER||Mean Difference (Net)|10.5||||0.363|TWO_SIDED|95.0|-13.0|34.1|||Repeated measures analysis|||CD3+CD4+CD25+CD127-, 12-Week FU||34.1|-13.0|0.363
70901259|NCT02799472|141290983|OTHER||Mean Difference (Net)|2.0||||0.788|TWO_SIDED|95.0|-13.0|17.0|||Repeated measures analysis|||CD3+CD4+foxP3+CD25+CD127-, Week 1||17.0|-13.0|0.788
70901260|NCT02799472|141290983|OTHER||Mean Difference (Net)|-2.2||||0.786|TWO_SIDED|95.0|-18.8|14.4|||Repeated measures analysis|||CD3+CD4+foxP3+CD25+CD127-, Week 4||14.4|-18.8|0.786
70901261|NCT02799472|141290983|OTHER||Mean Difference (Net)|-7.1||||0.433|TWO_SIDED|95.0|-25.4|11.2|||Repeated measures analysis|||CD3+CD4+foxP3+CD25+CD127-, Week 12||11.2|-25.4|0.433
70901262|NCT02799472|141290983|OTHER||Mean Difference (Net)|4.1||||0.55|TWO_SIDED|95.0|-9.8|18.0|||Repeated measures analysis|||CD3+CD4+foxP3+CD25+CD127-, 12-Week FU||18.0|-9.8|0.550
70901263|NCT02799472|141290984|OTHER||Mean Difference (Net)|14.6||||0.35|TWO_SIDED|95.0|-16.9|46.1|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3+38+DR+, Week 1||46.1|-16.9|0.350
70901264|NCT02799472|141290984|OTHER||Mean Difference (Net)|8.4||||0.697|TWO_SIDED|95.0|-35.3|52.0|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3+38+DR+, Week 4||52.0|-35.3|0.697
70901265|NCT02799472|141290984|OTHER||Mean Difference (Net)|-49.2||||0.249|TWO_SIDED|95.0|-135.2|36.8|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3+38+DR+, Week 12||36.8|-135.2|0.249
70901266|NCT02799472|141290984|OTHER||Mean Difference (Net)|-30.1||||0.119|TWO_SIDED|95.0|-68.6|8.3|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3+38+DR+, 12-Week FU||8.3|-68.6|0.119
70901267|NCT02799472|141290984|OTHER||Mean Difference (Net)|6.5||||0.403|TWO_SIDED|95.0|-9.3|22.4|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3-38+DR+, Week 1||22.4|-9.3|0.403
70901268|NCT02799472|141290984|OTHER||Mean Difference (Net)|-2.1||||0.91|TWO_SIDED|95.0|-39.4|35.2|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3-38+DR+, Week 4||35.2|-39.4|0.910
70901269|NCT02799472|141290984|OTHER||Mean Difference (Net)|-6.5||||0.718|TWO_SIDED|95.0|-43.1|30.1|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3-38+DR+, Week 12||30.1|-43.1|0.718
70901270|NCT02799472|141290984|OTHER||Mean Difference (Net)|-5.7||||0.687|TWO_SIDED|95.0|-34.4|23.0|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3-38+DR+, 12-Week FU||23.0|-34.4|0.687
70901271|NCT02799472|141290984|OTHER||Mean Difference (Net)|-56.0||||0.559|TWO_SIDED|95.0|-249.8|137.7|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3+38+DR+, Week 1||137.7|-249.8|0.559
70901272|NCT02799472|141290984|OTHER||Mean Difference (Net)|51.6||||0.47|TWO_SIDED|95.0|-93.9|197.0|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3+38+DR+, Week 4||197.0|-93.9|0.470
70901273|NCT02799472|141290984|OTHER||Mean Difference (Net)|-141.5||||0.675|TWO_SIDED|95.0|-829.2|546.3|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3+38+DR+, Week 12||546.3|-829.2|0.675
70901274|NCT02799472|141290984|OTHER||Mean Difference (Net)|-137.9||||0.08|TWO_SIDED|95.0|-294.0|18.2|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3+38+DR+, 12-Week FU||18.2|-294.0|0.080
70901275|NCT02799472|141290984|OTHER||Mean Difference (Net)|0.4||||0.989|TWO_SIDED|95.0|-60.5|61.3|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3-38+DR+, Week 1||61.3|-60.5|0.989
70901276|NCT02799472|141290984|OTHER||Mean Difference (Net)|-17.4||||0.634|TWO_SIDED|95.0|-94.3|59.6|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3-38+DR+, Week 4||59.6|-94.3|0.634
70901277|NCT02799472|141290984|OTHER||Mean Difference (Net)|59.4||||0.789|TWO_SIDED|95.0|-395.2|513.9|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3-38+DR+, Week 12||513.9|-395.2|0.789
70901278|NCT02799472|141290984|OTHER||Mean Difference (Net)|-47.2||||0.249|TWO_SIDED|95.0|-135.5|41.0|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3-38+DR+, 12-Week FU||41.0|-135.5|0.249
70901279|NCT02799472|141290984|OTHER||Mean Difference (Net)|3682.3||||0.234|TWO_SIDED|95.0|-2511.9|9876.5|||Repeated measures analysis|||CD45+CD3+CD8-CD4+, Week 1||9876.5|-2511.9|0.234
70901280|NCT02799472|141290984|OTHER||Mean Difference (Net)|-547.6||||0.875|TWO_SIDED|95.0|-7612.6|6517.3|||Repeated measures analysis|||CD45+CD3+CD8-CD4+, Week 4||6517.3|-7612.6|0.875
70901281|NCT02799472|141290984|OTHER||Mean Difference (Net)|-1106.0||||0.815|TWO_SIDED|95.0|-10706.0|8494.1|||Repeated measures analysis|||CD45+CD3+CD8-CD4+, Week 12||8494.1|-10706.0|0.815
70901282|NCT02799472|141290984|OTHER||Mean Difference (Net)|-3631.0||||0.23|TWO_SIDED|95.0|-9738.9|2476.8|||Repeated measures analysis|||CD45+CD3+CD8-CD4+, 12-Week FU||2476.8|-9738.9|0.230
70901283|NCT02799472|141290984|OTHER||Mean Difference (Net)|-515.6||||0.489|TWO_SIDED|95.0|-2021.4|990.1|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3+, Week 1||990.1|-2021.4|0.489
70901284|NCT02799472|141290984|OTHER||Mean Difference (Net)|-199.8||||0.822|TWO_SIDED|95.0|-2001.7|1602.0|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3+, Week 4||1602.0|-2001.7|0.822
70901285|NCT02799472|141290984|OTHER||Mean Difference (Net)|-253.5||||0.784|TWO_SIDED|95.0|-2136.7|1629.7|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3+, Week 12||1629.7|-2136.7|0.784
70901286|NCT02799472|141290984|OTHER||Mean Difference (Net)|225.1||||0.804|TWO_SIDED|95.0|-1633.1|2083.2|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3+, 12-Week FU||2083.2|-1633.1|0.804
70901287|NCT02799472|141290984|OTHER||Mean Difference (Net)|162.7||||0.719|TWO_SIDED|95.0|-754.5|1079.9|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3-, Week 1||1079.9|-754.5|0.719
70901288|NCT02799472|141290984|OTHER||Mean Difference (Net)|-183.5||||0.742|TWO_SIDED|95.0|-1317.4|950.3|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3-, Week 4||950.3|-1317.4|0.742
70901289|NCT02799472|141290984|OTHER||Mean Difference (Net)|-268.5||||0.658|TWO_SIDED|95.0|-1507.5|970.5|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3-, Week 12||970.5|-1507.5|0.658
70901290|NCT02799472|141290984|OTHER||Mean Difference (Net)|-197.6||||0.755|TWO_SIDED|95.0|-1499.3|1104.2|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3-, 12-Week FU||1104.2|-1499.3|0.755
70901291|NCT02799472|141290984|OTHER||Mean Difference (Net)|1150.0||||0.333|TWO_SIDED|95.0|-1250.0|3550.0|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3+, Week 1||3550.0|-1250.0|0.333
70901292|NCT02799472|141290984|OTHER||Mean Difference (Net)|-268.0||||0.891|TWO_SIDED|95.0|-4269.2|3733.3|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3+, Week 4||3733.3|-4269.2|0.891
70901293|NCT02799472|141290984|OTHER||Mean Difference (Net)|-1347.4||||0.633|TWO_SIDED|95.0|-7073.1|4378.3|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3+, Week 12||4378.3|-7073.1|0.633
70901294|NCT02799472|141290984|OTHER||Mean Difference (Net)|-1688.9||||0.41|TWO_SIDED|95.0|-5864.1|2486.2|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3+, 12-Week FU||2486.2|-5864.1|0.410
70901295|NCT02799472|141290984|OTHER||Mean Difference (Net)|3276.8||||0.196|TWO_SIDED|95.0|-1786.0|8339.6|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3-, Week 1||8339.6|-1786.0|0.196
70901296|NCT02799472|141290984|OTHER||Mean Difference (Net)|-447.3||||0.894|TWO_SIDED|95.0|-7285.5|6390.8|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3-, Week 4||6390.8|-7285.5|0.894
70901297|NCT02799472|141290984|OTHER||Mean Difference (Net)|1435.3||||0.6|TWO_SIDED|95.0|-4101.4|6972.0|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3-, Week 12||6972.0|-4101.4|0.600
70901298|NCT02799472|141290984|OTHER||Mean Difference (Net)|-1210.2||||0.534|TWO_SIDED|95.0|-5213.1|2792.7|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3-, 12-Week FU||2792.7|-5213.1|0.534
70901299|NCT02799472|141290985|OTHER||Mean Difference (Net)|2756.3||||0.328|TWO_SIDED|95.0|-2953.7|8466.3|||Repeated measures analysis|||CD14-HLA-DR+CD11cbr+CD123-, Week 1||8466.3|-2953.7|0.328
70901300|NCT02799472|141290985|OTHER||Mean Difference (Net)|-487.5||||0.895|TWO_SIDED|95.0|-8003.7|7028.6|||Repeated measures analysis|||CD14-HLA-DR+CD11cbr+CD123-, Week 4||7028.6|-8003.7|0.895
70901301|NCT02799472|141290985|OTHER||Mean Difference (Net)|-277.4||||0.961|TWO_SIDED|95.0|-12001.0|11446.2|||Repeated measures analysis|||CD14-HLA-DR+CD11cbr+CD123-, Week 12||11446.2|-12001.0|0.961
70901302|NCT02799472|141290985|OTHER||Mean Difference (Net)|-311.6||||0.956|TWO_SIDED|95.0|-11960.5|11337.4|||Repeated measures analysis|||CD14-HLA-DR+CD11cbr+CD123-, 12-Week FU||11337.4|-11960.5|0.956
70901303|NCT02799472|141290985|OTHER||Mean Difference (Net)|6866.9||||0.212|TWO_SIDED|95.0|-4230.7|17964.6|||Repeated measures analysis|||CD14br+CD16+, Week 1||17964.6|-4230.7|0.212
70901304|NCT02799472|141290985|OTHER||Mean Difference (Net)|8359.6||||0.227|TWO_SIDED|95.0|-5533.3|22252.5|||Repeated measures analysis|||CD14br+CD16+, Week 4||22252.5|-5533.3|0.227
70901305|NCT02799472|141290985|OTHER||Mean Difference (Net)|-22683.6||||0.04|TWO_SIDED|95.0|-44298.5|-1068.8|||Repeated measures analysis|||CD14br+CD16+, Week 12||-1068.8|-44298.5|0.040
70901306|NCT02799472|141290985|OTHER||Mean Difference (Net)|-3757.2||||0.741|TWO_SIDED|95.0|-27146.0|19631.6|||Repeated measures analysis|||CD14br+CD16+, 12-Week FU||19631.6|-27146.0|0.741
70901307|NCT02799472|141290985|OTHER||Mean Difference (Net)|-22417.0||||0.628|TWO_SIDED|95.0|-116677.8|71843.8|||Repeated measures analysis|||CD14br+CD16-, Week 1||71843.8|-116677.8|0.628
70901308|NCT02799472|141290985|OTHER||Mean Difference (Net)|27659.7||||0.321|TWO_SIDED|95.0|-28567.8|83887.1|||Repeated measures analysis|||CD14br+CD16-, Week 4||83887.1|-28567.8|0.321
70901309|NCT02799472|141290985|OTHER||Mean Difference (Net)|16182.9||||0.704|TWO_SIDED|95.0|-70377.0|102742.9|||Repeated measures analysis|||CD14br+CD16-, Week 12||102742.9|-70377.0|0.704
70901310|NCT02799472|141290985|OTHER||Mean Difference (Net)|-63419.4||||0.232|TWO_SIDED|95.0|-170364.9|43526.1|||Repeated measures analysis|||CD14br+CD16-, 12-Week FU||43526.1|-170364.9|0.232
70901311|NCT02799472|141290985|OTHER||Mean Difference (Net)|-6913.6||||0.366|TWO_SIDED|95.0|-22588.4|8761.1|||Repeated measures analysis|||CD14lo+CD16br+, Week 1||8761.1|-22588.4|0.366
70901312|NCT02799472|141290985|OTHER||Mean Difference (Net)|-2231.6||||0.603|TWO_SIDED|95.0|-10976.8|6513.6|||Repeated measures analysis|||CD14lo+CD16br+, Week 4||6513.6|-10976.8|0.603
70901313|NCT02799472|141290985|OTHER||Mean Difference (Net)|-10179.1||||0.084|TWO_SIDED|95.0|-21827.4|1469.2|||Repeated measures analysis|||CD14lo+CD16br+, Week 12||1469.2|-21827.4|0.084
70901314|NCT02799472|141290985|OTHER||Mean Difference (Net)|-20744.2||||0.026|TWO_SIDED|95.0|-38771.8|-2716.5|||Repeated measures analysis|||CD14lo+CD16br+, 12-Week FU||-2716.5|-38771.8|0.026
70901315|NCT02799472|141290986|OTHER||Mean Difference (Net)|178.2||||0.564|TWO_SIDED|95.0|-448.3|804.6|||Repeated measures analysis|||Week 1||804.6|-448.3|0.564
70901316|NCT02799472|141290986|OTHER||Mean Difference (Net)|540.4||||0.216|TWO_SIDED|95.0|-335.7|1416.5|||Repeated measures analysis|||Week 4||1416.5|-335.7|0.216
70901317|NCT02799472|141290986|OTHER||Mean Difference (Net)|-252.6||||0.629|TWO_SIDED|95.0|-1326.0|820.8|||Repeated measures analysis|||Week 12||820.8|-1326.0|0.629
70901318|NCT02799472|141290986|OTHER||Mean Difference (Net)|41.6||||0.932|TWO_SIDED|95.0|-962.2|1045.5|||Repeated measures analysis|||12-Week FU||1045.5|-962.2|0.932
70901319|NCT02799472|141290994|OTHER||Median Difference (Net)|-0.13||||0.547|TWO_SIDED|95.0|-2.32|2.23|||Repeated Measures Bayesian Model|||Week 4, For Posterior Probability Difference \<0||2.23|-2.32|0.547
70901320|NCT02799472|141290994|OTHER||Median Difference (Net)|-2.18||||0.948|TWO_SIDED|95.0|-4.77|0.51|||Repeated Measures Bayesian Model|||Week 12, For Posterior Probability Difference \<0||0.51|-4.77|0.948
70901321|NCT02799472|141290994|OTHER||Median Difference (Net)|-2.28||||0.949|TWO_SIDED|95.0|-5.02|0.45|||Repeated Measures Bayesian Model|||12-Week FU, For Posterior Probability Difference \<0||0.45|-5.02|0.949
70901322|NCT02799472|141290994|OTHER||Median Difference (Net)|-0.13||||0.453|TWO_SIDED|95.0|-2.32|2.23|||Repeated Measures Bayesian Model|||Week 4, For Posterior Probability Difference \>0||2.23|-2.32|0.453
70901323|NCT02799472|141290994|OTHER||Median Difference (Net)|-2.18||||0.052|TWO_SIDED|95.0|-4.77|0.51|||Repeated Measures Bayesian Model|||Week 12, For Posterior Probability Difference \>0||0.51|-4.77|0.052
70901324|NCT02799472|141290994|OTHER||Median Difference (Net)|-2.28||||0.051|TWO_SIDED|95.0|-5.02|0.45|||Repeated Measures Bayesian Model|||12-Week FU, For Posterior Probability Difference \>0||0.45|-5.02|0.051
70901325|NCT02799472|141290995|OTHER||Mean Difference (Net)|0.0||||0.94|TWO_SIDED|95.0|-0.2|0.3|||Repeated measures analysis|||Week 4||0.3|-0.2|0.940
70901326|NCT02799472|141290995|OTHER||Mean Difference (Net)|-0.8||||0.521|TWO_SIDED|95.0|-3.2|1.6|||Repeated measures analysis|||Week 12||1.6|-3.2|0.521
70901327|NCT02799472|141290995|OTHER||Mean Difference (Net)|-1.3||||0.396|TWO_SIDED|95.0|-4.4|1.8|||Repeated measures analysis|||12-Week FU||1.8|-4.4|0.396
70901328|NCT02799472|141290996|OTHER||Mean Difference (Net)|0.0||||0.945|TWO_SIDED|95.0|-1.1|1.2|||Repeated measures analysis|||Week 4||1.2|-1.1|0.945
70901329|NCT02799472|141290996|OTHER||Mean Difference (Net)|-0.4||||0.475|TWO_SIDED|95.0|-1.5|0.7|||Repeated measures analysis|||Week 12||0.7|-1.5|0.475
70901330|NCT02799472|141290996|OTHER||Mean Difference (Net)|-0.9||||0.086|TWO_SIDED|95.0|-2.0|0.1|||Repeated measures analysis|||12-Week FU||0.1|-2.0|0.086
70901331|NCT02799472|141290997|OTHER||Mean Difference (Net)|211.4||||0.874|TWO_SIDED|95.0|-2589.2|3012.0|||Repeated measures analysis|||Week 4||3012.0|-2589.2|0.874
70901332|NCT02799472|141290997|OTHER||Mean Difference (Net)|-504.8||||0.749|TWO_SIDED|95.0|-3730.4|2720.9|||Repeated measures analysis|||Week 12||2720.9|-3730.4|0.749
70901333|NCT02799472|141290997|OTHER||Mean Difference (Net)|-1536.0||||0.352|TWO_SIDED|95.0|-4884.2|1812.1|||Repeated measures analysis|||12-Week FU||1812.1|-4884.2|0.352
70901334|NCT02799472|141290998|OTHER||Mean Difference (Net)|0.0128||||0.291|TWO_SIDED|95.0|-0.0123|0.038|||Repeated measures analysis|||Week 4||0.0380|-0.0123|0.291
70901335|NCT02799472|141290998|OTHER||Mean Difference (Net)|0.0036||||0.375|TWO_SIDED|95.0|-0.0046|0.0118|||Repeated measures analysis|||Week 12||0.0118|-0.0046|0.375
70901336|NCT02799472|141290998|OTHER||Mean Difference (Net)|0.001||||0.588|TWO_SIDED|95.0|-0.0028|0.0049|||Repeated measures analysis|||12-Week FU||0.0049|-0.0028|0.588
70901337|NCT02799472|141290999|OTHER||Mean Difference (Net)|-0.0002||||0.915|TWO_SIDED|95.0|-0.0033|0.0029|||Repeated measures analysis|||Week 4||0.0029|-0.0033|0.915
70901338|NCT02799472|141290999|OTHER||Mean Difference (Net)|-0.0004||||0.771|TWO_SIDED|95.0|-0.0028|0.0021|||Repeated measures analysis|||Week 12||0.0021|-0.0028|0.771
70901339|NCT02799472|141290999|OTHER||Mean Difference (Net)|0.0005||||0.85|TWO_SIDED|95.0|-0.0048|0.0058|||Repeated measures analysis|||12-Week FU||0.0058|-0.0048|0.850
70901340|NCT01226511|141291000|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-2.65|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-4.03|-1.27|||Mixed Models Analysis|||||-1.27|-4.03|<0.001
70901341|NCT00674570|141291015|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.06|=|0.66|TWO_SIDED|95.0|-0.15|0.1|||Mixed Models Analysis|||Fear Conditioning Beginning (first trial)||.10|-.15|=.66
70901342|NCT00674570|141291015|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.06|=|0.41|TWO_SIDED|95.0|-0.17|0.07|||Mixed Models Analysis|||Fear Conditioning Beginning (first trial)||.07|-.17|=.41
70901343|NCT00674570|141291015|SUPERIORITY||Median Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.06|=|0.43|TWO_SIDED|95.0|-0.07|0.18|||Mixed Models Analysis|||Fear Conditioning End (last trial)||.18|-.07|=.43
70901344|NCT00674570|141291015|SUPERIORITY||Median Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.06|=|0.47|TWO_SIDED|95.0|-0.07|0.17|||Mixed Models Analysis|||Fear Conditioning End (last trial)||.17|-.07|=.47
70901345|NCT00674570|141291015|SUPERIORITY||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.05|=|0.065|TWO_SIDED|95.0|-0.01|0.2|||Mixed Models Analysis|||Fear Extinction Beginning (first trial)||.20|-.01|=.065
70901346|NCT00674570|141291015|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.05|=|0.34|TWO_SIDED|95.0|-0.05|0.15|||Mixed Models Analysis|||Fear Extinction Beginning (first trial)||.15|-.05|=.34
70901347|NCT00674570|141291015|SUPERIORITY||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.05|=|0.003|TWO_SIDED|95.0|0.06|0.26|||Mixed Models Analysis|||Extinction End (last trial)||.26|.06|=.003
70901348|NCT00674570|141291015|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.05||0.02|TWO_SIDED|95.0|0.02|0.22|||Mixed Models Analysis|||Extinction End (last trial)||.22|.02|.02
70901349|NCT00674570|141291015|OTHER||Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.06|=|0.006|TWO_SIDED|95.0|0.05|0.3|||Mixed Models Analysis|||Extinction Retention (first 2 trials) First trials were selected as a test of extinction retention, since repeated presentations of the CS without a UCS were expected to result in additional fear extinction.||.30|.05|=.006
70901350|NCT00674570|141291015|OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.06|=|0.01|TWO_SIDED|95.0|0.04|0.28|||Mixed Models Analysis|||Extinction retention||.28|.04|=.01
70901351|NCT01337986|141291016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.84|||||||Mixed Models Analysis|||Per protocol Analysis||||0.84
70901352|NCT01337986|141291016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Mixed Models Analysis|||Change in EDTRS between Visits 2 and 3.||||.29
70901353|NCT01337986|141291018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.01||0.64|TWO_SIDED|95.0|||||Mixed Models Analysis|||Null hypothesis: there will be no difference in the change relevant to baseline (visit 1) in EDTRS 5% contrast sensitivity with dalfampridine vs placebo.||||.64
70901354|NCT01337986|141291018|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11|||||||Mixed Models Analysis|||Null hypothesis for period effect: there will be no difference in the change relevant to baseline (visit 1) in EDTRS 5% contrast sensitivity for those who started on dalfampridine and crossed over to placebo, compared to those who started on placebo and crossed over to dalfampridine.||||0.11
70901355|NCT01337986|141291019|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93|||||||Regression, Logistic|||||||0.93
70901356|NCT01337986|141291020|SUPERIORITY_OR_OTHER_LEGACY|||||||0.34|||||||Regression, Logistic|||||||.34
70901357|NCT01337986|141291022|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.46||||0.04|TWO_SIDED|95.0|1.02|2.1||Probability of being in the lowest quartile for Visual Field Index deficits.|Regression, Logistic||Odds Ratio for Visual Field Index|||2.10|1.02|0.04
70901358|NCT01337986|141291023|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94|||||||Regression, Logistic|||||||0.94
70901359|NCT01337986|141291024|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
70901360|NCT01337986|141291025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.72|||||||Regression, Linear|||||||0.72
70901361|NCT00141739|141291030|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test||||||0.001
70901362|NCT00548132|141291050|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.46|STANDARD_DEVIATION|0.05||0.05|TWO_SIDED|95.0|0.24|0.9|||Cochran-Mantel-Haenszel|This was calculated based on the assumption that only 85% of eligible patients will consent to the study.|The standard of care is the numerator and the intervention group is the denominator|The null hypothesis is that the Bloostream infection per 1000 catheter days will be similar in both groups. In 2004, 6122 catheter days occurred in by both ICUs. If 15% of these were excluded, then 5203 catheter days/year will be eligible for analysis. The difference in infection rates will reach statistical significance at 12 months with a P-value of 0.04. At 24 months, the P-value will be more significant at 0.006.||0.90|0.24|0.05
70901363|NCT04074590|141291069|OTHER|A Bayesian analysis of clinical remission rate (based on total Mayo score) with binomial distribution, was modelled with baseline total Mayo score and treatment group as explanatory variables, to compare the remission rates between LYS006 and placebo groups.|Posterior estimate treatment difference|-3.29||||0.314|TWO_SIDED|90.0|-18.02|13.23||Posterior probability that clinical remission rate is better than placebo: Prob (diff\>0)|Bayesian analysis||90% credible intervals are reported on the treatment difference|||13.23|-18.02|0.314
70901364|NCT04074590|141291069|OTHER|A Bayesian analysis of clinical remission rate (based on total Mayo score) with binomial distribution, was modelled with baseline total Mayo score and treatment group as explanatory variables, to compare the remission rates between LYS006 and placebo groups.|Posterior estimate treatment difference|-3.29||||0.037|TWO_SIDED|90.0|-18.02|13.23||Posterior probability that clinical remission rate \>15% over placebo: Prob (diff\>0.15)|Bayesian analysis||90% credible intervals are reported on the treatment difference|||13.23|-18.02|0.037
70901365|NCT01355458|141291071|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||GEE: Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||||<0.001
70901366|NCT00691132|141291074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.7||||0.023|TWO_SIDED|95.0|-13.8|-1.2|||Mixed Models Analysis|||% difference between Placebo and PEITC periods in the ratio of \[pyridine-D4\]Hydroxy acid : \[pyridine-D4\] total NNAL||-1.2|-13.8|0.023
70901367|NCT00691132|141291075|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||ANOVA|||Total ITC||||0.005
70901368|NCT00691132|141291077|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED||||||ANOVA|||Total ITC||||0.017
70901369|NCT00691132|141291078|SUPERIORITY_OR_OTHER|||||||0.039|||||||Mixed Models Analysis|||||||0.039
70901370|NCT00691132|141291078|SUPERIORITY_OR_OTHER|||||||0.623|||||||Mixed Models Analysis|||||||0.623
70901371|NCT00691132|141291078|SUPERIORITY_OR_OTHER|||||||0.045|||||||Mixed Models Analysis|||||||0.045
70901372|NCT00361439|141291085|SUPERIORITY_OR_OTHER||||||<|0.02||95.0|||||Wilcoxon (Mann-Whitney)|||||||< 0.02
70901373|NCT00361439|141291086|SUPERIORITY_OR_OTHER||||||<|0.023||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.023
70901374|NCT00361439|141291087|SUPERIORITY_OR_OTHER||||||<|0.002||95.0|||||t-test, 2 sided|||||||<0.002
70901375|NCT00361439|141291088|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.010
70901376|NCT00755040|141291089|SUPERIORITY||Odds Ratio (OR)|1.11|||>|0.99|TWO_SIDED|95.0|||||Fisher Exact|||||||>0.99
70901377|NCT01061333|141291139|SUPERIORITY_OR_OTHER||Difference in LS mean|16.22|||<|0.0001|TWO_SIDED|90.0|10.74|21.69||p-value not adjusted for simultaneous multiple comparisons|ANCOVA|||||21.69|10.74|<0.0001
70901378|NCT01061333|141291139|SUPERIORITY_OR_OTHER||Difference in LS Mean|15.51||||0.0001|TWO_SIDED|90.0|10.0|21.02||p-value not adjusted for simultaneous multiple comparisons|ANCOVA|||||21.02|10.00|0.0001
70901379|NCT01061333|141291139|SUPERIORITY_OR_OTHER||Difference in LS Mean|8.49||||0.0432|TWO_SIDED|90.0|1.78|15.2||p-value not adjusted for simultaneous multiple comparisons|ANCOVA|||||15.20|1.78|0.0432
70901380|NCT01061333|141291140|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|1.27||||0.043|TWO_SIDED|90.0|1.05|1.54||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.54|1.05|0.0430
70901381|NCT01061333|141291140|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|1.41||||0.01|TWO_SIDED|90.0|1.15|1.72||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.72|1.15|0.0100
70901382|NCT01061333|141291140|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|1.3||||0.086|TWO_SIDED|90.0|1.01|1.67||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.67|1.01|0.0860
70901383|NCT01061333|141291141|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.59|||<|0.0001|TWO_SIDED|90.0|0.5|0.7||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||0.70|0.50|<0.0001
70901384|NCT01061333|141291141|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.59|||<|0.0001|TWO_SIDED|90.0|0.49|0.7||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||0.70|0.49|<0.0001
70901385|NCT01061333|141291141|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.87||||0.2679|TWO_SIDED|90.0|0.69|1.08||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.08|0.69|0.2679
70901386|NCT01061333|141291142|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.9||||0.7622|TWO_SIDED|90.0|0.51|1.59||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.59|0.51|0.7622
70901387|NCT01061333|141291142|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.94||||0.8468|TWO_SIDED|90.0|0.53|1.65||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated on log scale||||1.65|0.53|0.8468
70901388|NCT01061333|141291142|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.91||||0.614|TWO_SIDED|90.0|0.65|1.26||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.26|0.65|0.6140
70901389|NCT01061333|141291143|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.67||||0.0006|TWO_SIDED|90.0|0.57|0.8||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||0.80|0.57|0.0006
70901390|NCT01061333|141291143|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.79||||0.0291|TWO_SIDED|90.0|0.67|0.94||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||0.94|0.67|0.0291
70901391|NCT01061333|141291143|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.92||||0.3738|TWO_SIDED|90.0|0.77|1.08||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.08|0.77|0.3738
70901392|NCT01061333|141291144|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.03||||0.7501||90.0|0.88|1.2||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.20|0.88|0.7501
70901393|NCT01061333|141291144|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.01||||0.941|TWO_SIDED|90.0|0.81|1.25||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.25|0.81|0.9410
70901394|NCT01061333|141291144|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|0.89||||0.1165|TWO_SIDED|90.0|0.79|1.01||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.01|0.79|0.1165
70901395|NCT01061333|141291145|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.03||||0.8616|TWO_SIDED|90.0|0.76|1.41||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.41|0.76|0.8616
70901396|NCT01061333|141291145|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.06||||0.7512|TWO_SIDED|90.0|0.77|1.45||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.45|0.77|0.7512
70901397|NCT01061333|141291145|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|0.99||||0.9723|TWO_SIDED|90.0|0.72|1.37||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.37|0.72|0.9723
70901398|NCT01061333|141291146|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.3||||0.1983|TWO_SIDED|90.0|0.92|1.82||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.82|0.92|0.1983
70901399|NCT01061333|141291146|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.57||||0.0872|TWO_SIDED|90.0|1.02|2.42||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||2.42|1.02|0.0872
70901400|NCT01061333|141291146|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.22||||0.2499|TWO_SIDED|90.0|0.91|1.62||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.62|0.91|0.2499
70901401|NCT00803101|141291217|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was -(minus)10%. If the lower limit of the 2-sided 95% CI was \>-10%, then the null-hypothesis was rejected and it was concluded that Beriplex was non-inferior to plasma.~The sample size estimation assumed that hemostatic efficacy would be rated 'effective' in 85% of participants in the plasma group and 90% of participants in the Beriplex group. The power to show non-inferiority with these assumptions was greater than 80% for two treatment groups of 80 participants."|Difference in effective hemostasis (%)|14.3|||||TWO_SIDED|95.0|2.8|25.8||No P-value is provided as non-inferiority was assessed via calculation of the 95% CI for the difference (Beriplex minus plasma) in the percentage of participants with effective hemostasis.|95% confidence interval|The Newcombe-Wilson score method was used to estimate the 95% CI for the difference (Beriplex-plasma) in the % participants with effective hemostasis||The analysis of hemostatic efficacy was via calculation of the 95% confidence interval (CI) for the difference (Beriplex minus plasma) in the percentage of participants with effective hemostasis.||25.8|2.8|
70901402|NCT00803101|141291218|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was -(minus)10%. If the lower limit of the 2-sided 95% CI was \>-10%, then the null-hypothesis was rejected and it was concluded that Beriplex was non-inferior to plasma.~The sample size estimation assumed that hemostatic efficacy would be rated 'effective' in 85% of participants in the plasma group and 90% of participants in the Beriplex group. The power to show non-inferiority with these assumptions was greater than 80% for two treatment groups of 80 participants."|Difference in effective hemostasis (%)|45.3|||||TWO_SIDED|95.0|31.9|56.4||No P-value is provided as non-inferiority was assessed via calculation of the 95% CI for the difference (Beriplex minus plasma) in the percentage of participants with effective hemostasis.|Newcombe-Wilson score method|The Newcombe-Wilson score method was used to estimate the 95% CI for the difference (Beriplex-plasma) in the % pts with rapid decrease of the INR.||The analysis of rapid decrease of the INR was via calculation of the 95% CI for the difference (Beriplex minus plasma) in the percentage of participants with INR ≤ 1.3 at 30 minutes after the end of infusion.||56.4|31.9|
70901403|NCT01782742|141291224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.22|TWO_SIDED|95.0|-0.13|0.03|||t-test, 2 sided|||||0.03|-0.13|0.22
70901404|NCT01782742|141291225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.57|TWO_SIDED|95.0|-4.428|2.428|||t-test, 2 sided|||||2.428|-4.428|0.57
70901405|NCT01782742|141291226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.625||||0.83|TWO_SIDED|95.0|-5.029|6.279|||t-test, 2 sided|||||6.279|-5.029|0.83
70901406|NCT01782742|141291227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.000|0.000|
70901407|NCT01782742|141291228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.375||||0.94|TWO_SIDED|95.0|-9.674|8.924|||t-test, 2 sided|||||8.924|-9.674|0.94
70901408|NCT01782742|141291229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.563||||0.18|TWO_SIDED|95.0|-1.975|11.1|||t-test, 2 sided|||||11.100|-1.975|0.18
70901409|NCT01782742|141291237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.006||||0.46|TWO_SIDED|95.0|-0.01|0.021|||t-test, 2 sided|||||0.021|-0.010|0.46
70901410|NCT01782742|141291238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.53|TWO_SIDED|95.0|-0.02|0.04|||t-test, 2 sided|||||0.040|-0.020|0.53
70901411|NCT04858802|141291241|SUPERIORITY||Mean Difference (Net)|4.19|STANDARD_DEVIATION|19.08||0.059|TWO_SIDED|95.0|-0.2|8.6||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area minus balloon sinus dilation alone mean FSO cross-sectional area|The null hypothesis was that there would no difference in FSO cross-sectional area between treatment and control sides at Day 45.||8.6|-0.2|0.059
70901412|NCT04858802|141291242|SUPERIORITY||Mean Difference (Final Values)|1.48|STANDARD_DEVIATION|12.98||0.328|TWO_SIDED|95.0|-1.5|4.5||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area change from baseline to Day 45 minus balloon sinus dilation alone mean FSO cross-sectional area change from baseline to Day 45|Day 45||4.5|-1.5|0.328
70901413|NCT04858802|141291242|SUPERIORITY||Mean Difference (Final Values)|-2.75|STANDARD_DEVIATION|12.64||0.063|TWO_SIDED|95.0|-5.7|0.2||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area change from baseline to Day 180 minus balloon sinus dilation alone mean FSO cross-sectional area change from baseline to Day 180|Day 180||0.2|-5.7|0.063
70901414|NCT04858802|141291243|SUPERIORITY||Mean Difference (Final Values)|50.94|STANDARD_DEVIATION|430.8||0.306|TWO_SIDED|95.0|-47.5|149.4||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSOT volume minus balloon sinus dilation alone mean FSOT volume|Day 45||149.4|-47.5|0.306
70901415|NCT04858802|141291243|SUPERIORITY||Mean Difference (Final Values)|-27.44|STANDARD_DEVIATION|413.22||0.567|TWO_SIDED|95.0|-122.5|67.6|||t-test, 2 sided|Paired; the threshold for statistical significance was p = 0.05.|Difference = PROPEL Contour Sinus Implant mean FSOT volume minus balloon sinus dilation alone mean FSOT volume|Day 180||67.6|-122.5|0.567
70901416|NCT04858802|141291244|SUPERIORITY||Mean Difference (Net)|0.48|STANDARD_DEVIATION|1.92||0.031|TWO_SIDED|95.0|0.0|0.9||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO minimum diameter minus balloon sinus dilation alone mean FSO minimum diameter|Day 45||0.9|0.0|0.031
70901417|NCT04858802|141291244|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|2.27||0.943|TWO_SIDED|95.0|-0.5|0.5||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO minimum diameter minus balloon sinus dilation alone mean FSO minimum diameter|Day 180||0.5|-0.5|0.943
70901418|NCT04858802|141291245|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|1.24||0.715|TWO_SIDED|95.0|-0.3|0.2|||t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean Zinreich's modified Lund-Mackay score for the frontal sinus minus balloon sinus dilation alone mean Zinreich's modified Lund-Mackay score for the frontal sinus|Day 45||0.2|-0.3|0.715
70901419|NCT04858802|141291245|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_DEVIATION|0.96||0.129|TWO_SIDED|95.0|0.0|0.4|||t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean Zinreich's modified Lund-Mackay score for the frontal sinus minus balloon sinus dilation alone mean Zinreich's modified Lund-Mackay score for the frontal sinus|Day 180||0.4|0.0|0.129
70901420|NCT04858802|141291246|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.28|3.6||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided|||Day 21||3.60|0.28|1.00
70901421|NCT04858802|141291246|SUPERIORITY||Odds Ratio (OR)|0.79||||0.453|TWO_SIDED|95.0|0.36|1.73||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided|||Day 45||1.73|0.36|0.453
70901422|NCT04858802|141291246|SUPERIORITY||Odds Ratio (OR)|0.71||||0.219|TWO_SIDED|95.0|0.31|1.61||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided|||Day 90||1.61|0.31|0.219
70901423|NCT04858802|141291246|SUPERIORITY||Odds Ratio (OR)|0.71||||0.289|TWO_SIDED|95.0|0.31|1.61|||t-test, 2 sided|||Day 180||1.61|0.31|0.289
70901424|NCT04858802|141291247|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|21.12||0.971|TWO_SIDED|95.0|-4.9|4.8||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area minus balloon sinus dilation alone mean FSO cross-sectional area|Day 180||4.8|-4.9|0.971
70901425|NCT04858802|141291248|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.56||1|TWO_SIDED|95.0|-0.1|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided|||Day 45|Difference = PROPEL Contour Sinus Implant mean Lund-Mackay score for the frontal sinus at Day 45 minus balloon sinus dilation alone mean Lund-Mackay score for the frontal sinus at Day 45|0.1|-0.1|1.00
70901426|NCT04858802|141291248|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|0.42||0.288|TWO_SIDED|95.0|0.0|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean Lund-Mackay score for the frontal sinus at Day 180 minus balloon sinus dilation alone mean Lund-Mackay score for the frontal sinus at Day 180|Day 180||0.1|0.0|0.288
70901427|NCT04858802|141291249|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|0.64||0.225|TWO_SIDED|95.0|-0.2|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean Lund-Mackay score for the frontal sinus at Day 45 minus balloon sinus dilation alone mean Lund-Mackay score for the frontal sinus at Day 45|Day 45||0.1|-0.2|0.225
70901428|NCT04858802|141291249|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|0.65||0.388|TWO_SIDED|95.0|-0.2|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean Lund-Mackay score for the frontal sinus at Day 180 minus balloon sinus dilation alone modified Lund-Mackay score for the frontal sinus at Day 180|Day 180||0.1|-0.2|0.388
70901429|NCT04858802|141291250|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|0.68||0.537|TWO_SIDED|95.0|-0.2|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the frontal recess/FSO minus balloon sinus dilation alone mean adhesion/scarring grade in the frontal recess/FSO|Day 21||0.1|-0.2|0.537
70901430|NCT04858802|141291250|SUPERIORITY||Mean Difference (Final Values)|-0.18|STANDARD_DEVIATION|0.54||0.01|TWO_SIDED|95.0|-0.3|0.0||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the frontal recess/FSO minus balloon sinus dilation alone mean adhesion/scarring grade in the frontal recess/FSO|Day 45||0.0|-0.3|0.010
70901431|NCT04858802|141291250|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.7||0.003|TWO_SIDED|95.0|-0.4|-0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the frontal recess/FSO minus balloon sinus dilation alone mean adhesion/scarring grade in the frontal recess/FSO|Day 90||-0.1|-0.4|0.003
70901432|NCT04858802|141291250|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_DEVIATION|0.66||0.007|TWO_SIDED|95.0|-0.4|-0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the frontal recess/FSO minus balloon sinus dilation alone mean adhesion/scarring grade in the frontal recess/FSO|Day 180||-0.1|-0.4|0.007
70901433|NCT04858802|141291251|SUPERIORITY||Mean Difference (Final Values)|-2.46|STANDARD_DEVIATION|35.55||0.634|TWO_SIDED|95.0|-12.8|7.9||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean inflammation score in the frontal recess/FSO minus balloon sinus dilation alone mean inflammation score in the frontal recess/FSO|Day 21||7.9|-12.8|0.634
70901434|NCT04858802|141291251|SUPERIORITY||Mean Difference (Final Values)|-7.63|STANDARD_DEVIATION|29.04||0.048|TWO_SIDED|95.0|-15.2|-0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean inflammation score in the frontal recess/FSO minus balloon sinus dilation alone mean inflammation score in the frontal recess/FSO|Day 45||-0.1|-15.2|0.048
70901435|NCT04858802|141291251|SUPERIORITY||Mean Difference (Final Values)|-7.78|STANDARD_DEVIATION|28.79||0.028|TWO_SIDED|95.0|-14.7|-0.9||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean inflammation score in the frontal recess/FSO minus balloon sinus dilation alone mean inflammation score in the frontal recess/FSO|Day 90||-0.9|-14.7|0.028
70901436|NCT04858802|141291251|SUPERIORITY||Mean Difference (Final Values)|-6.76|STANDARD_DEVIATION|27.99||0.041|TWO_SIDED|95.0|-13.2|-0.3||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean inflammation score in the frontal recess/FSO minus balloon sinus dilation alone mean inflammation score in the frontal recess/FSO|Day 180||-0.3|-13.2|0.041
70901437|NCT04858802|141291252|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.96||0.063|TWO_SIDED|95.0|-0.5|0.0||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polypoid edema grade in the frontal recess/FSO minus balloon sinus dilation alone mean polypoid edema grade in the frontal recess/FSO|Day 21||0.0|-0.5|0.063
70901438|NCT04858802|141291252|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_DEVIATION|0.77||0.015|TWO_SIDED|95.0|-0.4|-0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polypoid edema grade in the frontal recess/FSO minus balloon sinus dilation alone mean polypoid edema grade in the frontal recess/FSO|Day 45||-0.1|-0.4|0.015
70901439|NCT04858802|141291252|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.78||0.007|TWO_SIDED|95.0|-0.4|-0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polypoid edema grade in the frontal recess/FSO minus balloon sinus dilation alone mean polypoid edema grade in the frontal recess/FSO|Day 90||-0.1|-0.4|0.007
70901440|NCT04858802|141291252|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_DEVIATION|0.75||0.034|TWO_SIDED|95.0|-0.4|0.0||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polypoid edema grade in the frontal recess/FSO minus balloon sinus dilation alone mean polypoid edema grade in the frontal recess/FSO|Day 180||0.0|-0.4|0.034
70901441|NCT04858802|141291253|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_DEVIATION|0.65||0.83|TWO_SIDED|95.0|-0.2|0.2||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the ethmoid sinus minus balloon sinus dilation alone mean adhesion/scarring grade in the ethmoid sinus|Day 21||0.2|-0.2|0.830
70901442|NCT04858802|141291253|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.59||0.829|TWO_SIDED|95.0|-0.2|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the ethmoid sinus minus balloon sinus dilation alone mean adhesion/scarring grade in the ethmoid sinus|Day 45||0.1|-0.2|0.829
70901443|NCT04858802|141291253|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_DEVIATION|0.64||0.132|TWO_SIDED|95.0|-0.3|0.0||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the ethmoid sinus minus balloon sinus dilation alone mean adhesion/scarring grade in the ethmoid sinus|Day 90||0.0|-0.3|0.132
70901444|NCT04858802|141291253|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|0.79||0.31|TWO_SIDED|95.0|-0.3|0.1|||t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the ethmoid sinus minus balloon sinus dilation alone mean adhesion/scarring grade in the ethmoid sinus|Day 180||0.1|-0.3|0.310
70901445|NCT04858802|141291254|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_DEVIATION|0.48||0.666|TWO_SIDED|95.0|-0.2|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polyp grade in the ethmoid sinus minus balloon sinus dilation alone mean polyp grade in the ethmoid sinus|Day 21||0.1|-0.2|0.666
70901446|NCT04858802|141291254|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.46||0.497|TWO_SIDED|95.0|-0.2|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polyp grade in the ethmoid sinus minus balloon sinus dilation alone mean polyp grade in the ethmoid sinus|Day 45||0.1|-0.2|0.497
70901447|NCT04858802|141291254|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_DEVIATION|0.5||0.235|TWO_SIDED|95.0|-0.2|0.0||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polyp grade in the ethmoid sinus minus balloon sinus dilation alone mean polyp grade in the ethmoid sinus|Day 90||0.0|-0.2|0.235
70901448|NCT04858802|141291254|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.41||0.677|TWO_SIDED|95.0|-0.1|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polyp grade in the ethmoid sinus minus balloon sinus dilation alone mean polyp grade in the ethmoid sinus|Day 180||0.1|-0.1|0.677
70901449|NCT04858802|141291255|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|2.48||0.868|TWO_SIDED|95.0|-0.7|0.6||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean CRS side-specific symptom total score minus balloon sinus dilation alone mean CRS side-specific symptom total score|Day 21||0.6|-0.7|0.868
70901450|NCT04858802|141291255|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_DEVIATION|2.3||0.823|TWO_SIDED|95.0|-0.5|0.7||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean CRS side-specific symptom total score minus balloon sinus dilation alone mean CRS side-specific symptom total score|Day 45||0.7|-0.5|0.823
70901451|NCT04858802|141291255|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|2.26||1|TWO_SIDED|95.0|-0.5|0.5||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean CRS side-specific symptom total score minus balloon sinus dilation alone mean CRS side-specific symptom total score|Day 90||0.5|-0.5|1.00
70901452|NCT04858802|141291255|SUPERIORITY||Mean Difference (Final Values)|-0.33|STANDARD_DEVIATION|2.16||0.188|TWO_SIDED|95.0|-0.8|0.2||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean CRS side-specific symptom total score minus balloon sinus dilation alone mean CRS side-specific symptom total score|Day 180||0.2|-0.8|0.188
70901453|NCT04858802|141291259|SUPERIORITY||Mean Difference (Net)|6.28|STANDARD_DEVIATION|18.12||0.025|TWO_SIDED|95.0|0.8|11.7||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area minus balloon sinus dilation alone mean FSO cross-sectional area|||11.7|0.8|0.025
70901454|NCT04858802|141291260|SUPERIORITY||Mean Difference (Final Values)|3.98|STANDARD_DEVIATION|12.49||0.04|TWO_SIDED|95.0|0.2|7.8||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area change from baseline to Day 45 minus balloon sinus dilation alone mean FSO cross-sectional area change from baseline to Day 45|Day 45||7.8|0.2|0.04
70901455|NCT04858802|141291260|SUPERIORITY||Median Difference (Final Values)|-3.45|STANDARD_DEVIATION|13.02||0.09|TWO_SIDED|95.0|-7.5|0.6||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area change from baseline to Day 180 minus balloon sinus dilation alone mean FSO cross-sectional area change from baseline to Day 180|Day 180||0.6|-7.5|0.09
70901456|NCT04858802|141291261|SUPERIORITY||Mean Difference (Final Values)|61.54|STANDARD_DEVIATION|460.18||0.375|TWO_SIDED|95.0|-76.7|199.8||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSOT volume minus balloon sinus dilation alone mean FSOT volume|Day 45||199.8|-76.7|0.375
70901457|NCT04858802|141291261|SUPERIORITY||Mean Difference (Final Values)|-51.98|STANDARD_DEVIATION|434.64||0.432|TWO_SIDED|95.0|-184.1|80.2||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSOT volume minus balloon sinus dilation alone mean FSOT volume|Day 180||80.2|-184.1|0.432
70901458|NCT04858802|141291262|SUPERIORITY||Mean Difference (Final Values)|0.74|STANDARD_DEVIATION|2.13||0.023|TWO_SIDED|95.0|0.1|1.4||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO minimum diameter minus balloon sinus dilation alone mean FSO minimum diameter|Day 45||1.4|0.1|0.023
70901459|NCT04858802|141291262|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_DEVIATION|2.24||0.646|TWO_SIDED|95.0|-0.8|0.5||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO minimum diameter minus balloon sinus dilation alone mean FSO minimum diameter|Day 180||0.5|-0.8|0.646
70901460|NCT02026232|141291263|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
70901461|NCT01529008|141291265|SUPERIORITY||Proportion treatment responder Differenc|-0.08||||0.539|TWO_SIDED|95.0|-0.35|0.18|||Fisher Exact||"Percentage of treatment responders in PREOB® group is 60.9% ((14/23)\*100), compared with 69.2% ((18/26)\*100) in Placebo.~Difference in percentage is -8.3 Difference in treatment responders proportion: PREOB® (0.609) - Placebo (0.692) = -0.08"|||0.18|-0.35|0.539
70901462|NCT02305381|141291266|SUPERIORITY_OR_OTHER||Treatment difference|-1.75|||<|0.0001|TWO_SIDED|95.0|-2.01|-1.5|||Mixed Models Analysis||Superiority for change in HbA1c was claimed if the upper limit of the 2-sided 95% CI for the estimated difference was below 0%.|Hierarchical testing was performed as per sequence listed below:Change in HbA1c: semaglutide 1.0 mg vs placebo. Change in HbA1c: semaglutide 0.5 mg vs placebo. Change in body weight: semaglutide 1.0 mg vs placebo. Change in body weight: semaglutide 0.5 mg vs placebo. Analysis was performed using MMRM with treatment, country and stratification variable (HbA1c at screening \[≤8.0% or \>8.0%\] crossed with use of metformin \[yes or no\]; 2 by 2 levels) as fixed factors and baseline value as covariate||-1.50|-2.01|< 0.0001
70901463|NCT02305381|141291266|SUPERIORITY_OR_OTHER||Treatment difference|-1.35|||<|0.0001|TWO_SIDED|95.0|-1.61|-1.1|||Mixed Models Analysis||Superiority for change in HbA1c was claimed if the upper limit of the 2-sided 95% CI for the estimated difference was below 0%.|Hierarchical testing was performed as per sequence listed below:Change in HbA1c: semaglutide 1.0 mg vs placebo. Change in HbA1c: semaglutide 0.5 mg vs placebo. Change in body weight: semaglutide 1.0 mg vs placebo. Change in body weight: semaglutide 0.5 mg vs placebo. Analysis was performed using MMRM with treatment, country and stratification variable (HbA1c at screening \[≤8.0% or \>8.0%\] crossed with use of metformin \[yes or no\]; 2 by 2 levels) as fixed factors and baseline value as covariate||-1.10|-1.61|< 0.0001
70901464|NCT05056870|141291280|SUPERIORITY|Superiority was declared if the upper limit of the 95% confidence interval of was below 0.00 logMAR.|Mean Difference|-0.097|STANDARD_ERROR_OF_MEAN|0.008|||TWO_SIDED|95.0|-0.113|-0.081|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Mean difference was calculated as Test - Control|||-0.081|-0.113|
70901465|NCT05056870|141291281|SUPERIORITY|Superiority was declared if the lower limit of the 95% confidence interval of was above 0.|Mean Difference|28.0|STANDARD_ERROR_OF_MEAN|2.69|||TWO_SIDED|95.0|22.6|33.3|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Mean difference was calculated as Test - Control|||33.3|22.6|
70901466|NCT05056870|141291282|NON_INFERIORITY|Non-Inferiority was declared if the upper limit of the 95% confidence interval of was below 0.05 logMAR.|Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.0061|||TWO_SIDED|95.0|-0.032|-0.008|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Mean difference was calculated as Test - Control|||-0.008|-0.032|
70901467|NCT05056870|141291283|SUPERIORITY|Superiority was declared if the lower limit of the 95% confidence interval of was above 1.|Mean Ratio|2.98|||||TWO_SIDED|95.0|1.73|5.11|||Generalized Linear Mixed Model||Mean Ratio was calculated as Test over Control|||5.11|1.73|
70901468|NCT02243202|141291316|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.3|-1.8|||Mixed Model for Repeated Measures|||||-1.8|-5.3|<0.001
70901469|NCT02243202|141291316|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.9||0.142|TWO_SIDED|95.0|-3.1|0.4|||Mixed Model for Repeated Measures|||||0.4|-3.1|0.142
70901470|NCT02243202|141291316|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-6.9|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-8.6|-5.2|||Mixed Model for Repeated Measures|||||-5.2|-8.6|<0.001
70901471|NCT02243202|141291317|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.15||||0.002|TWO_SIDED|95.0|1.7|10.14|||Generalized linear Mixed Model|||||10.14|1.70|0.002
70901472|NCT02243202|141291317|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.825|TWO_SIDED|95.0|0.41|3.06|||Generalized linear Mixed Model|||||3.06|0.41|0.825
70901473|NCT02243202|141291317|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.2|||<|0.001|TWO_SIDED|95.0|4.15|25.05|||Generalized linear Mixed Model|||||25.05|4.15|<0.001
70901474|NCT02243202|141291318|SUPERIORITY_OR_OTHER||Least Square Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|1.8||0.456|TWO_SIDED|95.0|-2.1|4.8|||Mixed Model for Repeated Measures|||||4.8|-2.1|0.456
70901475|NCT02243202|141291318|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.8||0.827|TWO_SIDED|95.0|-3.9|3.1|||Mixed Model for Repeated Measures|||||3.1|-3.9|0.827
70901476|NCT02243202|141291318|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|1.7||0.015|TWO_SIDED|95.0|-7.7|-0.8|||Mixed Model for Repeated Measures|||||-0.8|-7.7|0.015
70901477|NCT02243202|141291319|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.3|-1.7|||Mixed Model for Repeated Measures|||||-1.7|-5.3|<0.001
70901478|NCT02243202|141291319|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.9||0.153|TWO_SIDED|95.0|-3.1|0.5|||Mixed Model for Repeated Measures|||||0.5|-3.1|0.153
70901479|NCT02243202|141291319|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|0.9|<|0.001||95.0|-8.5|-4.9|||Mixed Model for Repeated Measures|||||-4.9|-8.5|<0.001
70901480|NCT00991341|141291331|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.44|TWO_SIDED|95.0|-0.6|0.26|||ANCOVA|The treatment groups were compared with respect to the change in MODS, adjusting for baseline MODS.|The longer storage red blood cell units arm is the reference category. After adjusting for baseline MODS, the difference in the means was -0.17, positive values are in favor of longer storage duration.|||0.26|-0.60|0.44
70901481|NCT00991341|141291332|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.5|TWO_SIDED|95.0|0.48|1.43|||Regression, Cox|The treatment groups were compared with respect to all-cause mortality, adjusting for baseline MODS.|The longer storage duration arm is the reference category.|||1.43|0.48|0.50
70901482|NCT00991341|141291333|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32||||0.2|TWO_SIDED|95.0|-0.82|0.17|||ANCOVA|The treatment groups were compared with respect to 28-day change in MODS, adjusting for baseline MODS.|The longer storage red blood cell units arm is the reference category. After adjusting for baseline MODS, the difference in the means was -0.32; positive values are in favor of longer storage duration.|||0.17|-0.82|0.20
70901483|NCT00991341|141291334|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.018||||0.5|TWO_SIDED|95.0|-0.033|0.069|||Fisher Exact||The difference in proportions between the two treatment arms was computed as the proportion of subjects with the event in the shorter storage duration arm minus the proportion of subjects with the event in the longer storage duration arm.|||0.069|-0.033|0.50
70901484|NCT00991341|141291335|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.027||||0.4|TWO_SIDED|95.0|-0.09|0.035|||Fisher Exact||The difference in proportions between the two treatment arms was computed as the proportion of subjects with the event in the shorter storage duration arm minus the proportion of subjects with the event in the longer storage duration arm.|||0.035|-0.090|0.40
70901485|NCT00991341|141291336|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.018||||0.41|TWO_SIDED|95.0|-0.059|0.023|||Fisher Exact||The difference in proportions between the two treatment arms was computed as the proportion of subjects with the event in the shorter storage duration arm minus the proportion of subjects with the event in the longer storage duration arm.|||0.023|-0.059|0.41
70901486|NCT00991341|141291337|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.75|TWO_SIDED|95.0|-0.62|0.37|||Kruskal-Wallis|||||0.37|-0.62|0.75
70901487|NCT00991341|141291338|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.62|TWO_SIDED|95.0|-0.08|0.05|||ANCOVA|The treatment arms were compared with respect to the change in creatinine, adjusting for the baseline creatinine value.|The longer storage red blood cell units arm is the reference category. After adjusting for baseline creatinine, the difference in the means was -0.02, positive values are in favor of longer storage duration.|||0.05|-0.08|0.62
70901488|NCT00991341|141291339|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.93||||0.35|TWO_SIDED|95.0|-2.11|5.98||The treatment arms were compared with respect to the change in troponin-I, adjusting for the baseline troponin-I value.|ANCOVA||The longer storage red blood cell units arm is the reference category. After adjusting for baseline troponin-I, the change in troponin-I values was 1.9 ng/mL higher in the shorter storage red blood cell units arm.|Troponin-I values recorded as 'too low to detect' were recoded as 0 since the median value of the minimum quantitative troponin-I value obtained among all participating sites was 0.01.||5.98|-2.11|0.35
70901489|NCT00991341|141291340|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Kruskal-Wallis|||||||0.10
70901490|NCT00991341|141291341|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.65|||<|0.01|TWO_SIDED|95.0|-0.89|-0.41|||ANCOVA||The longer storage red blood cell units arm is the reference category. After adjusting for baseline bilirubin, the change in bilirubin values was 0.65 mg/dL lower in the shorter storage red blood cell units arm.|||-0.41|-0.89|<0.01
70901491|NCT00991341|141291343|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.11|TWO_SIDED|95.0|0.98|1.25||The treatment groups were compared with respect to days to first post-operative bowel movement, adjusting for baseline MODS.|Regression, Cox||The longer storage duration arm is reference category.|||1.25|0.98|0.11
70901492|NCT00991341|141291344|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.22|TWO_SIDED|95.0|0.96|1.22|||Regression, Cox|The treatment groups were compared with respect to days to first post-operative solid food, adjusting for baseline MODS.|The longer storage duration arm is reference category.|||1.22|0.96|0.22
70901493|NCT00991341|141291345|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21||||0.71|TWO_SIDED|95.0|-0.59|1.0|||Kruskal-Wallis||The longer storage duration arm is reference category.|||1.00|-0.59|0.71
70901494|NCT00991341|141291346|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.015||||0.53|TWO_SIDED|95.0|-0.057|0.027|||Fisher Exact||The difference in proportions between the two treatment arms was computed as the proportion of subjects with the event in the shorter storage duration arm minus the proportion of subjects with the event in the longer storage duration arm.|||0.027|-0.057|0.53
70901495|NCT00246337|141291347|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||0.05 is the pre-specified significance level.|generalized linear model|The p-value is based on the average response of the MK0974 200mg, 400mg, and 600mg groups vs. placebo.||Only the MK0974 300mg, 400mg, and 600mg groups are included in the comparison with placebo based on the protocol-specified test statistics selection and the fact that all lower doses were discontinued after the interim analysis. Overall power =85%||||0.015
70901496|NCT00246337|141291348|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||0.05 is the pre-specified significance level.|generalized linear model|The p-value is based on the average response of the MK0974 200mg, 400mg, and 600mg groups vs. placebo.||Only the MK0974 300mg, 400mg, and 600mg groups are included in the comparison with placebo based on the protocol-specified test statistics selection and the fact that all lower doses were discontinued after the interim analysis.||||<0.001
70901497|NCT00246337|141291349|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||0.05 is the pre-specified significance level.|generalized linear model|||Only the MK0974 300mg, 400mg, and 600mg groups are included in the comparison with placebo based on the protocol-specified test statistics selection and the fact that all lower doses were discontinued after the interim analysis.||||<0.001
70901498|NCT00246337|141291350|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||0.05 is the pre-specified significance level.|generalized linear model|The p-value is based on the average response of the MK0974 200mg, 400mg, and 600mg groups vs. placebo.||Only the MK0974 300mg, 400mg, and 600mg groups are included in the comparison with placebo based on the protocol-specified test statistics selection and the fact that all lower doses were discontinued after the interim analysis.||||<0.001
70901499|NCT01966003|141291351|NON_INFERIORITY_OR_EQUIVALENCE|Clinical equivalence of the primary endpoint was demonstrated by comparing the 2-sided 90% CI of the risk ratio in objective response rate between ABP 215 and bevacizumab with an equivalence margin of (0.67, 1.5).|Risk Ratio (RR)|0.93|||||TWO_SIDED|90.0|0.8|1.09||||||The risk ratio (ABP 215/Bevacizumab) and 90% confidence interval (CI) were estimated using a generalized linear model adjusted for the stratification factors (region, sex, and ECOG performance status).||1.09|0.80|
70901500|NCT01966003|141291351|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.9|||||TWO_SIDED|90.0|-9.26|3.45||||||Risk difference (ABP 215 - Bevacizumab) and 90% CI were estimated using a generalized linear model adjusted for the randomization stratification factors geographic region, ECOG performance status, and sex.||3.45|-9.26|
70901501|NCT01966003|141291353|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03|||||TWO_SIDED|90.0|0.83|1.29||||||The hazard ratio for ABP 215 relative to bevacizumab was based on a stratified Cox proportional hazards model. Stratification factors are geographic region, ECOG performance status, and sex.||1.29|0.83|
70901502|NCT01966003|141291356|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|90.0|0.75|1.61||||||Hazard ratio for ABP 215 relative to bevacizumab, based on a stratified Cox proportional hazards model. Stratification factors are geographic region, ECOG performance status, and sex.||1.61|0.75|
70901503|NCT01187914|141291365|SUPERIORITY_OR_OTHER||Regression coefficient|0.13||||0.48||95.0|||||Regression, Linear|||||||0.48
70901504|NCT02287584|141291372|SUPERIORITY||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|2.04||0.007|TWO_SIDED|95.0|-9.6|-1.6||adjusted p value, Hochberg procedure|Mixed Models Analysis|||Using Mixed Model for Repeated Measures||-1.6|-9.6|0.007
70901505|NCT02287584|141291372|SUPERIORITY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-14.4|-6.4||adjusted p-value, Hochberg procedure|Mixed Models Analysis|||||-6.4|-14.4|<0.001
70901506|NCT02884414|141291390|OTHER|Paired Student's t-test.||||||0.44|||||||t-test, 2 sided|||||||0.44
70901507|NCT02798211|141291391|SUPERIORITY||Odds Ratio (OR)|3.51||||0.0011|TWO_SIDED|95.0|1.65|7.45|||Regression, Logistic|Statistical analysis (logistic regression) of ACR20 response in treatment period 1 (non-responder imputation)||secukinumab 300mg s.c. injection, 16 weeks||7.45|1.65|0.0011
70901508|NCT02798211|141291391|SUPERIORITY||Odds Ratio (OR)|1.92||||0.0961|TWO_SIDED|95.0|0.89|4.15|||Regression, Logistic|Statistical analysis (logistic regression) of ACR20 response in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, 16 weeks||4.15|0.89|0.0961
70901509|NCT02798211|141291392|SUPERIORITY||Odds Ratio (OR)|0.6||||0.333|TWO_SIDED|95.0|0.22|1.68|||Regression, Logistic|Statistical analysis (logistic regression) of presence of dactylitis by visit in treatment period 1 (non-responder imputation)||secukinumab 300 mg s.c. injection, 16 weeks||1.68|0.22|0.3330
70901510|NCT02798211|141291392|SUPERIORITY||Odds Ratio (OR)|0.4||||0.0841|TWO_SIDED|95.0|0.14|1.13|||Regression, Logistic|Statistical analysis (logistic regression) of presence of dactylitis in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, 16 weeks||1.13|0.14|0.0841
70901511|NCT02798211|141291393|SUPERIORITY||Odds Ratio (OR)|0.52||||0.1618|TWO_SIDED|95.0|0.21|1.3|||Regression, Logistic|Statistical analysis (logistic regression) of presence of enthesitis (SPARCC) in treatment period 1 (non-responder imputation)||secukinumab 300mg s.c. injection, 16 weeks||1.30|0.21|0.1618
70901512|NCT02798211|141291393|SUPERIORITY||Odds Ratio (OR)|0.46||||0.0898|TWO_SIDED|95.0|0.19|1.13|||Regression, Logistic|Statistical analysis (logistic regression) of presence of enthesitis (SPARCC) in treatment period 1 (non-responder imputation)||secukinumab 150mg s.c. injection, 16 weeks||1.13|0.19|0.0898
70901513|NCT02798211|141291394|SUPERIORITY||Odds Ratio (OR)|0.27||||0.0125|TWO_SIDED|95.0|0.09|0.75|||Regression, Logistic|Statistical analysis (logistic regression) of presence of enthesitis (LEI) in treatment period 1 (non-responder imputation)||secukinumab 300mg s.c. injection, 16 weeks||0.75|0.09|0.0125
70901514|NCT02798211|141291394|SUPERIORITY||Odds Ratio (OR)|0.25||||0.0086|TWO_SIDED|95.0|0.09|0.7|||Regression, Logistic|Statistical analysis (logistic regression) of presence of enthesitis (SPARCC) in treatment period 1 (non-responder imputation)||secukinumab 150mg s.c. injection, 16 weeks||0.70|0.09|0.0086
70901515|NCT02798211|141291395|SUPERIORITY||Odds Ratio (OR)|0.35||||0.0338|TWO_SIDED|95.0|0.13|0.92|||Regression, Logistic|Statistical analysis (logistic regression) of presence of enthesitis (SPARCC and LEI) in treatment period 1 (non-responder imputation)||secukinumab 300mg s.c. injection, 16 weeks||0.92|0.13|0.0338
70901516|NCT02798211|141291395|SUPERIORITY||Odds Ratio (OR)|0.36||||0.0359|TWO_SIDED|95.0|0.14|0.93|||Regression, Logistic|Statistical analysis (logistic regression) of presence of enthesitis (SPARCC and LEI) in treatment period 1 (non-responder imputation)||secukinumab 150mg s.c. injection, 16 weeks||0.93|0.14|0.0359
70901517|NCT02798211|141291396|SUPERIORITY||Odds Ratio, log|6.3||||0.0038|TWO_SIDED|95.0|1.81|21.88|||Regression, Logistic|Statistical analysis (logistic regression) of ACR50 response in treatment period 1 (non-responder imputation)||secukinumab 300mg s.c. injection, week 16||21.88|1.81|0.0038
70901518|NCT02798211|141291396|SUPERIORITY||Odds Ratio (OR)|4.77||||0.0149|TWO_SIDED|95.0|1.36|16.77|||Regression, Logistic|Statistical analysis (logistic regression) of ACR50 response by visit in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, week 16||16.77|1.36|0.0149
70901519|NCT02798211|141291397|SUPERIORITY||Odds Ratio, log|10.5||||0.0243|TWO_SIDED|95.0|1.36|81.3|||Regression, Logistic|Statistical analysis (logistic regression) of ACR70 response in treatment period 1 (non-responder imputation)||secukinumab 300mg s.c. injection, week 16||81.30|1.36|0.0243
70901520|NCT02798211|141291397|SUPERIORITY||Odds Ratio (OR)|5.42||||0.112|TWO_SIDED|95.0|0.67|43.64|||Regression, Logistic|Statistical analysis (logistic regression) of ACR70 response by visit in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, week 16||43.64|0.67|0.1120
70901521|NCT02798211|141291398|SUPERIORITY||Odds Ratio, log|9.49|||<|0.0001|TWO_SIDED|95.0|3.73|24.16|||Regression, Logistic|Statistical analysis (logistic regression) of PASI75 response by visit in treatment period 1 (non-responder imputation)||secukinumab 300 mg s.c. injection, week 16||24.16|3.73|<0.0001
70901522|NCT02798211|141291398|SUPERIORITY||Odds Ratio (OR)|6.38||||0.0001|TWO_SIDED|95.0|2.51|16.24|||Regression, Logistic|Statistical analysis (logistic regression) of PASI75 response by visit - in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, week 16||16.24|2.51|0.0001
70901523|NCT02798211|141291399|SUPERIORITY||Odds Ratio, log|9.86|||<|0.0001|TWO_SIDED|95.0|3.19|30.45|||Regression, Logistic|Statistical analysis (logistic regression) of PASI90 response in treatment period 1 (non-responder imputation)||secukinumab 300 mg s.c. injection, week 16||30.45|3.19|<.0001
70901524|NCT02798211|141291399|SUPERIORITY||Odds Ratio (OR)|5.21||||0.0043|TWO_SIDED|95.0|1.68|16.21|||Regression, Logistic|Statistical analysis (logistic regression) of PASI90 response in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, week 16||16.21|1.68|0.0043
70901525|NCT02798211|141291400|SUPERIORITY||Odds Ratio, log|14.38||||0.0107|TWO_SIDED|95.0|1.86|111.53|||Regression, Logistic|Statistical analysis (logistic regression) of PASI100 response by visit in treatment period 1 (non-responder imputation)||secukinumab 300 mg s.c. injection, week 16||111.53|1.86|0.0107
70901526|NCT02798211|141291400|SUPERIORITY||Odds Ratio (OR)|9.82||||0.0307|TWO_SIDED|95.0|1.24|77.9|||Regression, Logistic|Statistical analysis (logistic regression) of PAS100 response by in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, week 16||77.90|1.24|0.0307
70901527|NCT02798211|141291401|SUPERIORITY||LS Mean of Treatment Difference|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.45|-0.65|||ANCOVA|Statistical analysis (ANCOVA) of change from baseline in DAS28-CRP score in treatment period 1 (LOCF)||secukinumab 300mg s.c. injection, 16 weeks|"Standard Error of Treatment Difference~0.203"|-0.65|-1.45|<.0001
70901528|NCT02798211|141291401|SUPERIORITY||LS Means of Treatment Difference|-0.83|||<|0.0001|TWO_SIDED|95.0|-1.24|-0.43|||ANCOVA|Statistical analysis (ANCOVA) of change from baseline in DAS28-CRP score in treatment period 1 (LOCF)||secukinumab 150 mg s.c. injection|"LS Mean of Treatment Difference~0.207"|-0.43|-1.24|<.0001
70901529|NCT02798211|141291402|SUPERIORITY||LS Mean of Treatment Difference|-0.21||||0.0107|TWO_SIDED|95.0|-0.37|-0.05|||ANCOVA|Statistical analysis (ANCOVA) of change from baseline in HAQ-DI score by in treatment period 1 (LOCF)||secukinumab 300mg s.c. injection|"Standard Error of Treatment Difference~0.081"|-0.05|-0.37|0.0107
70901530|NCT02798211|141291402|SUPERIORITY|secukinumab 150 mg s.c. injection|LS Mean Treatment Difference|-0.13||||0.1109|TWO_SIDED|95.0|-0.3|0.03|||ANCOVA|Statistical analysis (ANCOVA) of change from baseline in HAQ-DI score by visit - in treatment period 1 (LOCF)|||"Standard Error of Treatment Difference~-0.083"|0.03|-0.30|0.1109
70901531|NCT01982435|141291409|OTHER|Measures were summarized using means, range and standard error of the means (SEM).|||||<|0.05||||||Two-sided paired t-tests and two-sided unpaired t-tests were respectively conducted to analyze efficacy endpoints between study initiation to end, and between monthly and TAE injection regimens.|t-test, 2 sided|||All analyses were performed with a significance level of 0.05 being assumed for all tests.||||<0.05
70901532|NCT01892345|141291439|OTHER|Treatment Effect|Hazard Ratio (HR)|0.058|||<|0.0001|TWO_SIDED|95.0|0.017|0.197|||Stratified Log-Rank Test||HR based on a stratified Cox proportional hazards model. Confidence interval = Wald confidence interval. HR for eculizumab compared with placebo represented a 94.2% reduction in the risk of relapse, 95% Wald confidence interval (80.3%, 98.3%).|||0.197|0.017|<0.0001
70901533|NCT01473381|141291521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.57||||0.0073|TWO_SIDED|95.0|-4.3|-0.84||P-value was adjusted for multiplicity.|Mixed-effect model|||||-0.84|-4.30|0.0073
70901534|NCT01473381|141291521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.82||||0.0034|TWO_SIDED|95.0|-4.57|-1.06||P-value was adjusted for multiplicity.|Mixed-effect model|||||-1.06|-4.57|0.0034
70901535|NCT01473381|141291521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.74||||0.002|TWO_SIDED|95.0|-4.48|-1.0||P-value was provided for assay sensitivity. It was not adjusted for multiplicity.|Mixed-effect model|||||-1.00|-4.48|0.0020
70901536|NCT01473381|141291522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0073|TWO_SIDED|95.0|-0.58|-0.13||P-value was adjusted for multiplicity.|Mixed-effect model|||||-0.13|-0.58|0.0073
70901537|NCT01473381|141291522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.0097|TWO_SIDED|95.0|-0.55|-0.1||P-value was adjusted for multiplicity.|Mixed-effect model|||||-0.10|-0.55|0.0097
70901538|NCT01473381|141291522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0025|TWO_SIDED|95.0|-0.57|-0.12||P-value was provided for assay sensitivity. It was not adjusted for multiplicity.|Mixed-effect model|||||-0.12|-0.57|0.0025
70901539|NCT01473381|141291523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.3563|TWO_SIDED|95.0|-3.9|10.9||P-value was adjusted for multiplicity.|Cochran-Mantel-Haenszel|The Mean Difference (Final Values), as well as 95% Confidence Interval, are in units of percentage.||||10.9|-3.9|0.3563
70901540|NCT01473381|141291523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1||||0.1611|TWO_SIDED|95.0|-0.4|14.6||P-value was adjusted for multiplicity.|Cochran-Mantel-Haenszel|The Mean Difference (Final Values), as well as 95% Confidence Interval, are in units of percentage.||||14.6|-0.4|0.1611
70901541|NCT01473381|141291523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7||||0.2672|TWO_SIDED|95.0|-2.7|12.2||P-value was provided for assay sensitivity. It was not adjusted for multiplicity.|Cochran-Mantel-Haenszel|The Mean Difference (Final Values), as well as 95% Confidence Interval, are in units of percentage.||||12.2|-2.7|0.2672
70901542|NCT01889186|141291548|SUPERIORITY||||||<|0.001|||||||Clopper-Pearson exact method|||The ORR for ABT-199 was tested to reject the null hypothesis of ORR = 40%. If the null hypothesis is rejected and the ORR is higher than 40%, then ABT-199 has been shown to have an ORR significantly higher than 40%.The p-value is from the exact binomial distribution comparing ABT-199 ORR to the 40% historical control rate.||||<0.001
70901543|NCT01257880|141291562|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U test was used to test the null hypothesis that basilar artery vasomotor reactivity was equivalent between the two groups.||||0.39
70901544|NCT03802864|141291568|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
70901545|NCT03802864|141291569|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||||||0.37
70901546|NCT03802864|141291570|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
70901547|NCT03802864|141291571|SUPERIORITY|||||||0.28|||||||Regression, Linear|||||||0.28
70901548|NCT03802864|141291572|SUPERIORITY|||||||0.78|||||||Log Rank|||||||0.78
70901549|NCT03802864|141291573|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
70901550|NCT03802864|141291574|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
70901551|NCT04710927|141291610|OTHER||Odds Ratio (OR)|0.7|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
70901552|NCT04710927|141291610|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70901553|NCT02007434|141291632|SUPERIORITY_OR_OTHER||LS Mean Placebo-adjusted Difference|0.24|STANDARD_ERROR_OF_MEAN|0.59||0.6803|TWO_SIDED|95.0|-0.93|1.41|||ANCOVA||Paradigm 1 - Paradigm 2|Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.||1.41|-0.93|0.6803
70901554|NCT02007434|141291632|SUPERIORITY_OR_OTHER||LS Mean Placebo-adjusted Difference|0.39|STANDARD_ERROR_OF_MEAN|0.61||0.5206|TWO_SIDED|95.0|-0.82|1.6|||ANCOVA||Paradigm 1 - Paradigm 3|Day 0, 1 Minute. Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.||1.60|-0.82|0.5206
70901555|NCT02007434|141291632|SUPERIORITY_OR_OTHER||LS Mean Placebo-adjusted Difference|0.3|STANDARD_ERROR_OF_MEAN|0.58||0.606|TWO_SIDED|395.0|-0.86|1.46|||ANCOVA||Paradigm 1 - Paradigm 4|Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.||1.46|-0.86|0.6060
70901556|NCT02007434|141291632|SUPERIORITY_OR_OTHER||LS Mean Placebo-adjusted Difference|0.15|STANDARD_ERROR_OF_MEAN|0.56||0.7935|TWO_SIDED|95.0|-0.98|1.27|||ANCOVA||Paradigm 2 - Paradigm 3|Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.||1.27|-0.98|0.7935
70901557|NCT02007434|141291632|SUPERIORITY_OR_OTHER||LS Mean Placebo-adjusted Difference|0.06|STANDARD_ERROR_OF_MEAN|0.55||0.914|TWO_SIDED|95.0|-1.03|1.15|||ANCOVA||Paradigm 2 - Paradigm 4|Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.||1.15|-1.03|0.9140
70901558|NCT02007434|141291632|SUPERIORITY_OR_OTHER||LS Mean Placebo-adjusted Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.56||0.8754|TWO_SIDED|95.0|-1.21|1.04|||ANCOVA||Paradigm 3 - Paradigm 4|Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.||1.04|-1.21|0.8754
70901559|NCT01287611|141291643|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Group sample sizes of 51 in study group and 65 in control group achieve 98% power to detect a difference between the group proportions of -0.3300. The proportion in study group is assumed to be 0.4800 under the null hypothesis and 0.1500 under the alternative hypothesis. The proportion in control group is 0.4800. The test statistic used is the two-sided Z test with pooled variance. The significance level of the test was targeted at 0.0500.||||||0.0001|||||||Chi-squared|||||||0.0001
70901560|NCT01287611|141291644|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Group sample sizes of 51 in study group and 65 in control group achieve 98% power to detect a difference between the group proportions of -0.3300. The proportion in study group is assumed to be 0.4800 under the null hypothesis and 0.1500 under the alternative hypothesis. The proportion in control group is 0.4800. The test statistic used is the two-sided Z test with pooled variance. The significance level of the test was targeted at 0.0500.||||||0.001|||||||t-test, 2 sided|||||||0.001
70901561|NCT01856712|141291645|SUPERIORITY||Odds Ratio (OR)|1.71|||||TWO_SIDED|95.0|0.35|9.98||||||||9.98|0.35|
70901562|NCT03299686|141291662|SUPERIORITY||Mean Difference (Net)|0.027|STANDARD_DEVIATION|0.043||0.7374|TWO_SIDED|80.0|-0.029|0.082||Probability CJM112 better than placebo|Bayesian linear repeated measures model||||Lower limit and upper limit represents the Credibility Interval from the Bayesian analysis.|0.082|-0.029|0.7374
70901563|NCT03299686|141291663|SUPERIORITY||Mean Difference (Net)|0.913|STANDARD_ERROR_OF_MEAN|1.434||0.263|TWO_SIDED|80.0|-0.939|2.766||1-sided p-value; p-value smaller than 0.1 is considered as statistically significant|Mixed Models Analysis|||||2.766|-0.939|0.263
70901564|NCT03299686|141291664|SUPERIORITY||Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.14||0.061|TWO_SIDED|80.0|-0.41|-0.04||1-sided p-value; p-value smaller than 0.1 is considered as statistically significant|Mixed Models Analysis|||||-0.04|-0.41|0.061
70901565|NCT03299686|141291665|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.13||0.04|TWO_SIDED|80.0|-0.4|-0.06||1-sided p-value; p-value smaller than 0.1 is considered as statistically significant|Mixed Models Analysis|||||-0.06|-0.40|0.040
70901566|NCT00860067|141291734|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV was to be declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for post dose A/H1N1 GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the A/H1N1 post-dose GMT ratio: (FluMist B/Yamagata A/H1N1 + FluMist B/Victoria A/H1N1) divided by Q/LAIV A/H1N1.|Ratio of geometric mean|1.09|||||TWO_SIDED|95.0|1.01|1.18|||Bootstrapping|Confidence intervals calculated based on bootstrapping method.||A/H1N1: Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CI for the ratio of A/H1N1 GMTs for the specified comparison. Geometric mean titers for the A/H1N1 influenza antibody measurements were calculated as: GMT = antilog\^e (mean \[log\^e x\]) where x was the assay result and e was the natural logarithm.||1.18|1.01|
70901567|NCT00860067|141291734|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV was to be declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for post dose A/H3N2 GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the A/H3N2 post-dose GMT ratio: (FluMist B/Yamagata A/H3N2 + FluMist B/Victoria A/H3N2) divided by Q/LAIV A/H3N2.|Ratio of geometric means|1.05|||||TWO_SIDED|95.0|0.96|1.14|||Bootstrapping|Confidence intervals calculated based on bootstrapping method.||A/H3N2: Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CI for the ratio of A/H3N2 GMTs for the specified comparison. Geometric mean titers for the A/H3N2 influenza antibody measurements were calculated as: GMT = antilog\^e (mean \[log\^e x\]) where x was the assay result and e was the natural logarithm.||1.14|0.96|
70901568|NCT00860067|141291734|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV was to be declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for post dose B/Yamagata GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the B/Yamagata post-dose GMT ratio: (FluMist B/Yamagata) divided by (Q/LAIV B/Yamagata).|Ratio of geometric mean|1.1|||||TWO_SIDED|95.0|0.97|1.25|||Bootstrapping|Confidence intervals calculated based on bootstrapping method.||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CI for the ratio of B/Yamagata GMTs for the specified comparison. Geometric mean titers for the B/Yamagata influenza antibody measurements were calculated as: GMT = antilog\^e (mean \[log\^e x\]) where x was the assay result and e was the natural logarithm.||1.25|0.97|
70901569|NCT00860067|141291734|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV was to be declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for post dose B/Victoria GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the B/Victoria post-dose GMT ratio: (FluMist B/Victoria) divided by (Q/LAIV B/Victoria).|Ratio of geometric means|0.92|||||TWO_SIDED|95.0|0.82|1.03|||Bootstrapping|Confidence intervals were calculated based on bootstrapping method.||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CI for the ratio of B/Victoria GMTs for the specified comparison. Geometric mean titers for the B/Victoria influenza antibody measurements were calculated as: GMT = antilog\^e (mean \[log\^e x\]) where x was the assay result and e was the natural logarithm.||1.03|0.82|
70901570|NCT00560612|141291764|SUPERIORITY|||||||0.7054|||||||t-test, 2 sided|||||||0.7054
70901571|NCT00560612|141291765|SUPERIORITY|||||||0.4583|||||||t-test, 2 sided|||||||0.4583
70901572|NCT00560612|141291766|SUPERIORITY|||||||0.7443|||||||t-test, 2 sided|||||||0.7443
70901573|NCT00560612|141291767|SUPERIORITY|||||||0.065|||||||t-test, 2 sided|||||||0.065
70901574|NCT01060553|141291778|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||t-test, 2 sided|||for mcs||||.15
70901575|NCT01060553|141291778|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||t-test, 2 sided|||for pcs||||.28
70901576|NCT01060553|141291779|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||t-test, 2 sided|||for sleep duration||||.34
70901577|NCT01060553|141291779|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||for sleep disturbance||||.001
70901578|NCT01060553|141291779|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||t-test, 2 sided|||for sleep latency||||.015
70901579|NCT02481375|141291791|OTHER||Marginal means|0.0|||<|0.05|TWO_SIDED|95.0|||||Regression, Linear|||Marginal means (95% CI) of ferritin concentrations at 12-weeks using a generalized mixed-effects model with adjustments for baseline values and village clusters||||<0.05
70901580|NCT04037436|141291801|OTHER|GEE|GEE|1.65||||0.05|TWO_SIDED|95.0|-4.44|7.73|||GEE|To model the interaction between exposure to the MoveStrong program and site on secondary outcomes we applied a generalized estimating equation (GEE).||To model the interaction between exposure to the MoveStrong program and site on secondary outcomes we applied a generalized estimating equation (GEE).||7.73|-4.44|0.05
70901581|NCT03338621|141291804|SUPERIORITY||Cox Proportional Hazard|2.93|||<|0.001|TWO_SIDED|95.0|2.17|3.96|||Log Rank|||||3.96|2.17|<0.001
70901582|NCT02037438|141291816|SUPERIORITY_OR_OTHER||Provider-Effect Adjusted Difference|0.03|STANDARD_ERROR_OF_MEAN|0.075||0.687|TWO_SIDED||||||see Comments|Finite-Mixture Models with Fixed Effects for Providers||||||0.687
70901583|NCT02037438|141291817|SUPERIORITY_OR_OTHER||Provider-Effect Adjusted Difference|-0.007|STANDARD_ERROR_OF_MEAN|0.539||0.989|TWO_SIDED||||||see Comments|Heteroscedasticity-Consistent Linear Regression with Fixed Effects for Providers and Baseline Covariate||||||0.989
70901584|NCT02037438|141291818|SUPERIORITY_OR_OTHER||Provider-Effect Adjusted Difference|0.114|STANDARD_ERROR_OF_MEAN|0.141||0.417|TWO_SIDED||||||see Comments|Finite-Mixture Models with Fixed Effects for Providers||||||0.417
70901585|NCT02037438|141291819|SUPERIORITY_OR_OTHER||Provider-Effect Adjusted Difference|0.057|STANDARD_ERROR_OF_MEAN|0.078||0.468|TWO_SIDED||||||see Comments|Finite-Mixture Models with Fixed Effects for Providers||||||0.468
70901586|NCT02037438|141291820|SUPERIORITY_OR_OTHER||Provider-Effect Adjusted Difference|0.177|STANDARD_ERROR_OF_MEAN|0.061||0.003|TWO_SIDED||||||see Comments|Finite-Mixture Models with Fixed Effects for Providers||||||0.003
70901587|NCT02255032|141291821|SUPERIORITY||Mean Difference (Final Values)|-164.44|STANDARD_DEVIATION|173.148||0.0017|TWO_SIDED|95.0|-256.7|-72.2||The primary analysis of the primary efficacy endpoint was the comparison between the Baseline and Month 2 values for the 4 mg treatment group. No adjustments for multiplicity were necessary.|Paired t-test, two-sided|||"A paired t-test was used to assess the statistical significance of the change between Baseline and Month 2.~A sample size of 16 subjects would have 80% power to detect a difference of 75, assuming a standard deviation of 100, using a paired t-test with a 0.050 two-sided significance level."||-72.2|-256.7|0.0017
70901588|NCT05375955|141291822|OTHER||Risk Difference (RD)|12.4||||0.0711|TWO_SIDED|95.0|-4.1|29.4|||Chan and Zhang (1999) method|||||29.4|-4.1|0.0711
70901589|NCT05375955|141291822|OTHER||Risk Difference (RD)|10.1||||0.129|TWO_SIDED|95.0|-6.1|26.8|||Chan and Zhang (1999) method|||||26.8|-6.1|0.1290
70901590|NCT05375955|141291823|OTHER||Risk Difference (RD)|6.3||||0.2712|TWO_SIDED|95.0|-10.8|24.3|||Chan and Zhang (1999) method|||||24.3|-10.8|0.2712
70901591|NCT05375955|141291823|OTHER||Risk Difference (RD)|28.3||||0.0028|TWO_SIDED|95.0|7.7|47.5|||Chan and Zhang (1999) method|||||47.5|7.7|0.0028
70901592|NCT05375955|141291823|OTHER||Risk Difference (RD)|36.6||||0.0003|TWO_SIDED|95.0|14.7|56.4|||Chan and Zhang (1999) method|||||56.4|14.7|0.0003
70901593|NCT05375955|141291824|OTHER||Risk Difference (RD)|0.1||||0.5701|TWO_SIDED|95.0|-10.2|10.7|||Chan and Zhang (1999) method|||Week 1||10.7|-10.2|0.5701
70901594|NCT05375955|141291824|OTHER||Risk Difference (RD)|2.5||||0.3269|TWO_SIDED|95.0|-8.4|14.1|||Chan and Zhang (1999) method|||Week 1||14.1|-8.4|0.3269
70901595|NCT05375955|141291824|OTHER||Risk Difference (RD)|9.6||||0.0532|TWO_SIDED|95.0|-2.0|23.7|||Chan and Zhang (1999) method|||Week 2||23.7|-2.0|0.0532
70901596|NCT05375955|141291824|OTHER||Risk Difference (RD)|4.9||||0.1705|TWO_SIDED|95.0|-6.1|17.6|||Chan and Zhang (1999) method|||Week 2||17.6|-6.1|0.1705
70901597|NCT05375955|141291824|OTHER||Risk Difference (RD)|0.5||||0.5123|TWO_SIDED|95.0|-14.4|15.7|||Chan and Zhang (1999) method|||Week 4||15.7|-14.4|0.5123
70901598|NCT05375955|141291824|OTHER||Risk Difference (RD)|5.3||||0.2751|TWO_SIDED|95.0|-10.7|22.1|||Chan and Zhang (1999) method|||Week 4||22.1|-10.7|0.2751
70901599|NCT05375955|141291824|OTHER||Risk Difference (RD)|7.8||||0.2736|TWO_SIDED|95.0|-8.9|24.8|||Chan and Zhang (1999) method|||Week 6||24.8|-8.9|0.2736
70901600|NCT05375955|141291824|OTHER||Risk Difference (RD)|3.0||||0.3967|TWO_SIDED|95.0|-13.0|19.8|||Chan and Zhang (1999) method|||Week 6||19.8|-13.0|0.3967
70901601|NCT05375955|141291824|OTHER||Risk Difference (RD)|3.1||||0.3997|TWO_SIDED|95.0|-13.6|20.2|||Chan and Zhang (1999) method|||Week 8||20.2|-13.6|0.3997
70901602|NCT05375955|141291824|OTHER||Risk Difference (RD)|-1.6||||0.5461|TWO_SIDED|95.0|-17.7|15.3|||Chan and Zhang (1999) method|||Week 8||15.3|-17.7|0.5461
70901603|NCT05375955|141291824|OTHER||Risk Difference (RD)|7.8||||0.2736|TWO_SIDED|95.0|-8.9|24.8|||Chan and Zhang (1999) method|||Week 10||24.8|-8.9|0.2736
70901604|NCT05375955|141291824|OTHER||Risk Difference (RD)|5.4||||0.2754|TWO_SIDED|95.0|-11.0|22.1|||Chan and Zhang (1999) method|||Week 10||22.1|-11.0|0.2754
70901605|NCT05375955|141291824|OTHER||Risk Difference (RD)|12.6||||0.0977|TWO_SIDED|95.0|-4.8|30.3|||Chan and Zhang (1999) method|||Week 12||30.3|-4.8|0.0977
70901606|NCT05375955|141291824|OTHER||Risk Difference (RD)|14.9||||0.0542|TWO_SIDED|95.0|-2.8|33.2|||Chan and Zhang (1999) method|||Week 12||33.2|-2.8|0.0542
70901607|NCT05375955|141291825|OTHER||Risk Difference (RD)|3.0||||0.2578|TWO_SIDED|95.0|-7.8|15.8|||Chan and Zhang (1999) method|||Week 1||15.8|-7.8|0.2578
70901608|NCT05375955|141291825|OTHER||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-10.6|10.1|||Chan and Zhang (1999) method|||Week 1||10.1|-10.6|1.0000
70901609|NCT05375955|141291825|OTHER||Risk Difference (RD)|9.1||||0.0436|TWO_SIDED|95.0|-2.1|24.3|||Chan and Zhang (1999) method|||Week 1||24.3|-2.1|0.0436
70901610|NCT05375955|141291825|OTHER||Risk Difference (RD)|9.1||||0.0436|TWO_SIDED|95.0|-2.1|24.3|||Chan and Zhang (1999) method|||Week 2||24.3|-2.1|0.0436
70901611|NCT05375955|141291825|OTHER||Risk Difference (RD)|2.9||||0.2697|TWO_SIDED|95.0|-7.8|14.9|||Chan and Zhang (1999) method|||Week 2||14.9|-7.8|0.2697
70901612|NCT05375955|141291825|OTHER||Risk Difference (RD)|15.2||||0.0104|TWO_SIDED|95.0|3.2|32.0|||Chan and Zhang (1999) method|||Week 2||32.0|3.2|0.0104
70901613|NCT05375955|141291825|OTHER||Risk Difference (RD)|15.2||||0.0104|TWO_SIDED|95.0|3.2|32.0|||Chan and Zhang (1999) method|||Week 4||32.0|3.2|0.0104
70901614|NCT05375955|141291825|OTHER||Risk Difference (RD)|14.3||||0.0129|TWO_SIDED|95.0|2.6|30.3|||Chan and Zhang (1999) method|||Week 4||30.3|2.6|0.0129
70901615|NCT05375955|141291825|OTHER||Risk Difference (RD)|21.2||||0.0024|TWO_SIDED|95.0|8.0|38.9|||Chan and Zhang (1999) method|||Week 4||38.9|8.0|0.0024
70901616|NCT05375955|141291825|OTHER||Risk Difference (RD)|21.2||||0.0024|TWO_SIDED|95.0|8.0|38.9|||Chan and Zhang (1999) method|||Week 6||38.9|8.0|0.0024
70901617|NCT05375955|141291825|OTHER||Risk Difference (RD)|22.9||||0.0018|TWO_SIDED|95.0|9.5|40.1|||Chan and Zhang (1999) method|||Week 6||40.1|9.5|0.0018
70901618|NCT05375955|141291825|OTHER||Risk Difference (RD)|33.3||||0.0001|TWO_SIDED|95.0|17.8|51.8|||Chan and Zhang (1999) method|||Week 6||51.8|17.8|0.0001
70901619|NCT05375955|141291825|OTHER||Risk Difference (RD)|15.2||||0.0259|TWO_SIDED|95.0|-0.1|32.5|||Chan and Zhang (1999) method|||Week 8||32.5|-0.1|0.0259
70901620|NCT05375955|141291825|OTHER||Risk Difference (RD)|22.8||||0.0038|TWO_SIDED|95.0|6.3|40.4|||Chan and Zhang (1999) method|||Week 8||40.4|6.3|0.0038
70901621|NCT05375955|141291825|OTHER||Risk Difference (RD)|30.4||||0.0007|TWO_SIDED|95.0|12.2|48.9|||Chan and Zhang (1999) method|||Week 8||48.9|12.2|0.0007
70901622|NCT05375955|141291825|OTHER||Risk Difference (RD)|21.5||||0.0146|TWO_SIDED|95.0|2.1|41.2|||Chan and Zhang (1999) method|||Week 10||41.2|2.1|0.0146
70901623|NCT05375955|141291825|OTHER||Risk Difference (RD)|19.7||||0.0205|TWO_SIDED|95.0|1.0|38.9|||Chan and Zhang (1999) method|||Week 10||38.9|1.0|0.0205
70901624|NCT05375955|141291825|OTHER||Risk Difference (RD)|39.7||||0.0002|TWO_SIDED|95.0|17.1|59.3|||Chan and Zhang (1999) method|||Week 10||59.3|17.1|0.0002
70901625|NCT05375955|141291825|OTHER||Risk Difference (RD)|12.6||||0.1245|TWO_SIDED|95.0|-7.8|32.6|||Chan and Zhang (1999) method|||Week 12||32.6|-7.8|0.1245
70901626|NCT05375955|141291825|OTHER||Risk Difference (RD)|11.0||||0.1431|TWO_SIDED|95.0|-9.1|31.5|||Chan and Zhang (1999) method|||Week 12||31.5|-9.1|0.1431
70901627|NCT05375955|141291825|OTHER||Risk Difference (RD)|36.8||||0.0007|TWO_SIDED|95.0|12.2|56.8|||Chan and Zhang (1999) method|||Week 12||56.8|12.2|0.0007
70901628|NCT05375955|141291826|OTHER||Risk Difference (RD)|2.5||||0.3269|TWO_SIDED|95.0|-8.4|14.1|||Chan and Zhang (1999) method|||Week 1||14.1|-8.4|0.3269
70901629|NCT05375955|141291826|OTHER||Risk Difference (RD)|2.5||||0.3269|TWO_SIDED|95.0|-8.4|14.1|||Chan and Zhang (1999) method|||Week 1||14.1|-8.4|0.3269
70901630|NCT05375955|141291826|OTHER||Risk Difference (RD)|4.9||||0.1705|TWO_SIDED|95.0|-6.1|17.6|||Chan and Zhang (1999) method|||Week 2||17.6|-6.1|0.1705
70901631|NCT05375955|141291826|OTHER||Risk Difference (RD)|7.3||||0.1118|TWO_SIDED|95.0|-3.9|20.5|||Chan and Zhang (1999) method|||Week 2||20.5|-3.9|0.1118
70901632|NCT05375955|141291826|OTHER||Risk Difference (RD)|5.2||||0.2751|TWO_SIDED|95.0|-9.5|20.5|||Chan and Zhang (1999) method|||Week 4||20.5|-9.5|0.2751
70901633|NCT05375955|141291826|OTHER||Risk Difference (RD)|2.8||||0.3857|TWO_SIDED|95.0|-11.4|17.6|||Chan and Zhang (1999) method|||Week 4||17.6|-11.4|0.3857
70901634|NCT05375955|141291826|OTHER||Risk Difference (RD)|7.5||||0.1429|TWO_SIDED|95.0|-6.4|22.6|||Chan and Zhang (1999) method|||Week 6||22.6|-6.4|0.1429
70901635|NCT05375955|141291826|OTHER||Risk Difference (RD)|7.5||||0.1429|TWO_SIDED|95.0|-6.4|22.6|||Chan and Zhang (1999) method|||Week 6||22.6|-6.4|0.1429
70901636|NCT05375955|141291826|OTHER||Risk Difference (RD)|9.8||||0.1119|TWO_SIDED|95.0|-4.4|25.3|||Chan and Zhang (1999) method|||Week 8||25.3|-4.4|0.1119
70901637|NCT05375955|141291826|OTHER||Risk Difference (RD)|2.7||||0.3755|TWO_SIDED|95.0|-10.7|16.7|||Chan and Zhang (1999) method|||Week 8||16.7|-10.7|0.3755
70901638|NCT05375955|141291826|OTHER||Risk Difference (RD)|7.7||||0.2547|TWO_SIDED|95.0|-8.4|24.3|||Chan and Zhang (1999) method|||Week 10||24.3|-8.4|0.2547
70901639|NCT05375955|141291826|OTHER||Risk Difference (RD)|2.9||||0.3928|TWO_SIDED|95.0|-12.7|18.6|||Chan and Zhang (1999) method|||Week 10||18.6|-12.7|0.3928
70901640|NCT05375955|141291827|OTHER||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-10.6|11.0|||Chan and Zhang (1999) method|||Week 1||11.0|-10.6|1.0000
70901641|NCT05375955|141291827|OTHER||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-10.6|10.1|||Chan and Zhang (1999) method|||Week 1||10.1|-10.6|1.0000
70901642|NCT05375955|141291827|OTHER||Risk Difference (RD)|3.0||||0.2578|TWO_SIDED|95.0|-7.8|15.8|||Chan and Zhang (1999) method|||Week 1||15.8|-7.8|0.2578
70901643|NCT05375955|141291827|OTHER||Risk Difference (RD)|6.1||||0.0993|TWO_SIDED|95.0|-4.9|20.7|||Chan and Zhang (1999) method|||Week 2||20.7|-4.9|0.0993
70901644|NCT05375955|141291827|OTHER||Risk Difference (RD)|5.7||||0.114|TWO_SIDED|95.0|-5.3|19.2|||Chan and Zhang (1999) method|||Week 2||19.2|-5.3|0.1140
70901645|NCT05375955|141291827|OTHER||Risk Difference (RD)|9.1||||0.0436|TWO_SIDED|95.0|-2.1|24.3|||Chan and Zhang (1999) method|||Week 2||24.3|-2.1|0.0436
70901646|NCT05375955|141291827|OTHER||Risk Difference (RD)|6.1||||0.0993|TWO_SIDED|95.0|-4.9|20.7|||Chan and Zhang (1999) method|||Week 4||20.7|-4.9|0.0993
70901647|NCT05375955|141291827|OTHER||Risk Difference (RD)|17.1||||0.0071|TWO_SIDED|95.0|4.9|33.9|||Chan and Zhang (1999) method|||Week 4||33.9|4.9|0.0071
70901648|NCT05375955|141291827|OTHER||Risk Difference (RD)|15.2||||0.0104|TWO_SIDED|95.0|3.2|32.0|||Chan and Zhang (1999) method|||Week 4||32.0|3.2|0.0104
70901649|NCT05375955|141291827|OTHER||Risk Difference (RD)|15.2||||0.0104|TWO_SIDED|95.0|3.2|32.0|||Chan and Zhang (1999) method|||Week 6||32.0|3.2|0.0104
70901650|NCT05375955|141291827|OTHER||Risk Difference (RD)|17.1||||0.0071|TWO_SIDED|95.0|4.9|33.9|||Chan and Zhang (1999) method|||Week 6||33.9|4.9|0.0071
70901651|NCT05375955|141291827|OTHER||Risk Difference (RD)|24.2||||0.0011|TWO_SIDED|95.0|10.4|42.3|||Chan and Zhang (1999) method|||Week 6||42.3|10.4|0.0011
70901652|NCT05375955|141291827|OTHER||Risk Difference (RD)|9.1||||0.0436|TWO_SIDED|95.0|-2.1|24.3|||Chan and Zhang (1999) method|||Week 8||24.3|-2.1|0.0436
70901653|NCT05375955|141291827|OTHER||Risk Difference (RD)|28.6||||0.0003|TWO_SIDED|95.0|14.2|46.3|||Chan and Zhang (1999) method|||Week 8||46.3|14.2|0.0003
70901654|NCT05375955|141291827|OTHER||Risk Difference (RD)|27.3||||0.0007|TWO_SIDED|95.0|12.9|45.8|||Chan and Zhang (1999) method|||Week 8||45.8|12.9|0.0007
70901655|NCT05375955|141291827|OTHER||Risk Difference (RD)|9.3||||0.1256|TWO_SIDED|95.0|-6.6|26.4|||Chan and Zhang (1999) method|||Week 10||26.4|-6.6|0.1256
70901656|NCT05375955|141291827|OTHER||Risk Difference (RD)|25.5||||0.0038|TWO_SIDED|95.0|7.0|44.8|||Chan and Zhang (1999) method|||Week 10||44.8|7.0|0.0038
70901657|NCT05375955|141291827|OTHER||Risk Difference (RD)|33.5||||0.0007|TWO_SIDED|95.0|12.8|52.6|||Chan and Zhang (1999) method|||Week 10||52.6|12.8|0.0007
70901658|NCT05375955|141291828|OTHER||Risk Difference (RD)|2.5||||0.3269|TWO_SIDED|95.0|-8.4|14.1|||Chan and Zhang (1999) method|||Week 1||14.1|-8.4|0.3269
70901659|NCT05375955|141291828|OTHER||Risk Difference (RD)|2.5||||0.3269|TWO_SIDED|95.0|-8.4|14.1|||Chan and Zhang (1999) method|||Week 1||14.1|-8.4|0.3269
70901660|NCT05375955|141291828|OTHER||Risk Difference (RD)|2.6||||0.3585|TWO_SIDED|95.0|-9.2|15.5|||Chan and Zhang (1999) method|||Week 2||15.5|-9.2|0.3585
70901661|NCT05375955|141291828|OTHER||Risk Difference (RD)|7.4||||0.129|TWO_SIDED|95.0|-5.3|22.1|||Chan and Zhang (1999) method|||Week 2||22.1|-5.3|0.1290
70901662|NCT05375955|141291828|OTHER||Risk Difference (RD)|5.3||||0.2751|TWO_SIDED|95.0|-10.7|22.1|||Chan and Zhang (1999) method|||Week 4||22.1|-10.7|0.2751
70901663|NCT05375955|141291828|OTHER||Risk Difference (RD)|7.7||||0.2547|TWO_SIDED|95.0|-8.4|24.3|||Chan and Zhang (1999) method|||Week 4||24.3|-8.4|0.2547
70901664|NCT05375955|141291828|OTHER||Risk Difference (RD)|5.2||||0.2751|TWO_SIDED|95.0|-9.5|20.5|||Chan and Zhang (1999) method|||Week 6||20.5|-9.5|0.2751
70901665|NCT05375955|141291828|OTHER||Risk Difference (RD)|12.3||||0.0658|TWO_SIDED|95.0|-3.8|28.8|||Chan and Zhang (1999) method|||Week 6||28.8|-3.8|0.0658
70901666|NCT05375955|141291828|OTHER||Risk Difference (RD)|5.3||||0.2751|TWO_SIDED|95.0|-10.7|22.1|||Chan and Zhang (1999) method|||Week 8||22.1|-10.7|0.2751
70901667|NCT05375955|141291828|OTHER||Risk Difference (RD)|5.3||||0.2751|TWO_SIDED|95.0|-10.7|22.1|||Chan and Zhang (1999) method|||Week 8||22.1|-10.7|0.2751
70901668|NCT05375955|141291828|OTHER||Risk Difference (RD)|3.1||||0.3997|TWO_SIDED|95.0|-13.6|20.2|||Chan and Zhang (1999) method|||Week 10||20.2|-13.6|0.3997
70901669|NCT05375955|141291828|OTHER||Risk Difference (RD)|3.1||||0.3997|TWO_SIDED|95.0|-13.6|20.2|||Chan and Zhang (1999) method|||Week 10||20.2|-13.6|0.3997
70901670|NCT05375955|141291828|OTHER||Risk Difference (RD)|7.9||||0.2736|TWO_SIDED|95.0|-9.5|25.7|||Chan and Zhang (1999) method|||Week 12||25.7|-9.5|0.2736
70901671|NCT05375955|141291828|OTHER||Risk Difference (RD)|12.7||||0.1119|TWO_SIDED|95.0|-5.6|31.0|||Chan and Zhang (1999) method|||Week 12||31.0|-5.6|0.1119
70901672|NCT05375955|141291829|OTHER||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-10.6|11.0|||Chan and Zhang (1999) method|||Week 1||11.0|-10.6|1.0000
70901673|NCT05375955|141291829|OTHER||Risk Difference (RD)|2.9||||0.2697|TWO_SIDED|95.0|-7.8|14.9|||Chan and Zhang (1999) method|||Week 1||14.9|-7.8|0.2697
70901674|NCT05375955|141291829|OTHER||Risk Difference (RD)|3.0||||0.2578|TWO_SIDED|95.0|-7.8|15.8|||Chan and Zhang (1999) method|||Week 1||15.8|-7.8|0.2578
70901675|NCT05375955|141291829|OTHER||Risk Difference (RD)|6.1||||0.0993|TWO_SIDED|95.0|-4.9|20.7|||Chan and Zhang (1999) method|||Week 2||20.7|-4.9|0.0993
70901676|NCT05375955|141291829|OTHER||Risk Difference (RD)|5.7||||0.114|TWO_SIDED|95.0|-5.3|19.2|||Chan and Zhang (1999) method|||Week 2||19.2|-5.3|0.1140
70901677|NCT05375955|141291829|OTHER||Risk Difference (RD)|9.1||||0.0436|TWO_SIDED|95.0|-2.1|24.3|||Chan and Zhang (1999) method|||Week 2||24.3|-2.1|0.0436
70901678|NCT05375955|141291829|OTHER||Risk Difference (RD)|6.1||||0.0993|TWO_SIDED|95.0|-4.9|20.7|||Chan and Zhang (1999) method|||Week 4||20.7|-4.9|0.0993
70901679|NCT05375955|141291829|OTHER||Risk Difference (RD)|17.1||||0.0071|TWO_SIDED|95.0|4.9|33.9|||Chan and Zhang (1999) method|||Week 4||33.9|4.9|0.0071
70901680|NCT05375955|141291829|OTHER||Risk Difference (RD)|15.2||||0.0104|TWO_SIDED|95.0|3.2|32.0|||Chan and Zhang (1999) method|||Week 4||32.0|3.2|0.0104
70901681|NCT05375955|141291829|OTHER||Risk Difference (RD)|15.2||||0.0104|TWO_SIDED|95.0|3.2|32.0|||Chan and Zhang (1999) method|||Week 6||32.0|3.2|0.0104
70901682|NCT05375955|141291829|OTHER||Risk Difference (RD)|17.1||||0.0071|TWO_SIDED|95.0|4.9|33.9|||Chan and Zhang (1999) method|||Week 6||33.9|4.9|0.0071
70901683|NCT05375955|141291829|OTHER||Risk Difference (RD)|24.2||||0.0011|TWO_SIDED|95.0|10.4|42.3|||Chan and Zhang (1999) method|||Week 6||42.3|10.4|0.0011
70901684|NCT05375955|141291829|OTHER||Risk Difference (RD)|9.1||||0.0436|TWO_SIDED|95.0|-2.1|24.3|||Chan and Zhang (1999) method|||Week 8||24.3|-2.1|0.0436
70901685|NCT05375955|141291829|OTHER||Risk Difference (RD)|28.6||||0.0003|TWO_SIDED|95.0|14.2|46.3|||Chan and Zhang (1999) method|||Week 8||46.3|14.2|0.0003
70901686|NCT05375955|141291829|OTHER||Risk Difference (RD)|27.3||||0.0007|TWO_SIDED|95.0|12.9|45.8|||Chan and Zhang (1999) method|||Week 8||45.8|12.9|0.0007
70901687|NCT05375955|141291829|OTHER||Risk Difference (RD)|6.3||||0.2712|TWO_SIDED|95.0|-10.8|24.3|||Chan and Zhang (1999) method|||Week 10||24.3|-10.8|0.2712
70901688|NCT05375955|141291829|OTHER||Risk Difference (RD)|25.5||||0.0056|TWO_SIDED|95.0|5.4|44.8|||Chan and Zhang (1999) method|||Week 10||44.8|5.4|0.0056
70901689|NCT05375955|141291829|OTHER||Risk Difference (RD)|30.6||||0.0017|TWO_SIDED|95.0|9.7|50.5|||Chan and Zhang (1999) method|||Week 10||50.5|9.7|0.0017
70901690|NCT05375955|141291829|OTHER||Risk Difference (RD)|3.4||||0.3929|TWO_SIDED|95.0|-14.9|21.6|||Chan and Zhang (1999) method|||Week 12||21.6|-14.9|0.3929
70901691|NCT05375955|141291829|OTHER||Risk Difference (RD)|28.2||||0.004|TWO_SIDED|95.0|7.0|47.7|||Chan and Zhang (1999) method|||Week 12||47.7|7.0|0.0040
70901692|NCT05375955|141291829|OTHER||Risk Difference (RD)|33.7||||0.0012|TWO_SIDED|95.0|10.4|53.7|||Chan and Zhang (1999) method|||Week 12||53.7|10.4|0.0012
70901693|NCT05375955|141291832|OTHER||Risk Difference (RD)|2.8||||0.3255|TWO_SIDED|95.0|-8.5|15.8|||Chan and Zhang (1999) method|||Week 1||15.8|-8.5|0.3255
70901694|NCT05375955|141291832|OTHER||Risk Difference (RD)|-2.5||||0.7181|TWO_SIDED|95.0|-13.3|8.3|||Chan and Zhang (1999) method|||Week 1||8.3|-13.3|0.7181
70901695|NCT05375955|141291832|OTHER||Risk Difference (RD)|18.4||||0.0022|TWO_SIDED|95.0|7.0|34.3|||Chan and Zhang (1999) method|||Week 2||34.3|7.0|0.0022
70901696|NCT05375955|141291832|OTHER||Risk Difference (RD)|14.7||||0.0064|TWO_SIDED|95.0|3.7|31.1|||Chan and Zhang (1999) method|||Week 2||31.1|3.7|0.0064
70901697|NCT05375955|141291832|OTHER||Risk Difference (RD)|13.7||||0.0659|TWO_SIDED|95.0|-3.4|31.5|||Chan and Zhang (1999) method|||Week 4||31.5|-3.4|0.0659
70901698|NCT05375955|141291832|OTHER||Risk Difference (RD)|19.4||||0.0189|TWO_SIDED|95.0|0.9|38.5|||Chan and Zhang (1999) method|||Week 4||38.5|0.9|0.0189
70901699|NCT05375955|141291832|OTHER||Risk Difference (RD)|3.6||||0.3962|TWO_SIDED|95.0|-14.9|22.3|||Chan and Zhang (1999) method|||Week 6||22.3|-14.9|0.3962
70901700|NCT05375955|141291832|OTHER||Risk Difference (RD)|9.0||||0.2333|TWO_SIDED|95.0|-10.4|29.1|||Chan and Zhang (1999) method|||Week 6||29.1|-10.4|0.2333
70901701|NCT05375955|141291832|OTHER||Risk Difference (RD)|3.6||||0.3962|TWO_SIDED|95.0|-14.9|22.3|||Chan and Zhang (1999) method|||Week 8||22.3|-14.9|0.3962
70901702|NCT05375955|141291832|OTHER||Risk Difference (RD)|11.9||||0.1353|TWO_SIDED|95.0|-7.9|32.7|||Chan and Zhang (1999) method|||Week 8||32.7|-7.9|0.1353
70901703|NCT05375955|141291832|OTHER||Risk Difference (RD)|6.2||||0.2791|TWO_SIDED|95.0|-12.8|25.7|||Chan and Zhang (1999) method|||Week 10||25.7|-12.8|0.2791
70901704|NCT05375955|141291832|OTHER||Risk Difference (RD)|9.0||||0.2333|TWO_SIDED|95.0|-10.4|29.1|||Chan and Zhang (1999) method|||Week 10||29.1|-10.4|0.2333
70901705|NCT05375955|141291832|OTHER||Risk Difference (RD)|11.3||||0.1295|TWO_SIDED|95.0|-7.3|30.6|||Chan and Zhang (1999) method|||Week 12||30.6|-7.3|0.1295
70901706|NCT05375955|141291832|OTHER||Risk Difference (RD)|20.3||||0.0247|TWO_SIDED|95.0|0.1|40.2|||Chan and Zhang (1999) method|||Week 12||40.2|0.1|0.0247
70901707|NCT05375955|141291833|OTHER||Risk Difference (RD)|-4.3||||0.7278|TWO_SIDED|95.0|-21.9|11.5|||Chan and Zhang (1999) method|||Week 1||11.5|-21.9|0.7278
70901708|NCT05375955|141291833|OTHER||Risk Difference (RD)|8.2||||0.2548|TWO_SIDED|95.0|-11.5|28.2|||Chan and Zhang (1999) method|||Week 1||28.2|-11.5|0.2548
70901709|NCT05375955|141291833|OTHER||Risk Difference (RD)|0.9||||0.5162|TWO_SIDED|95.0|-17.5|21.9|||Chan and Zhang (1999) method|||Week 1||21.9|-17.5|0.5162
70901710|NCT05375955|141291833|OTHER||Risk Difference (RD)|9.3||||0.1663|TWO_SIDED|95.0|-11.4|30.7|||Chan and Zhang (1999) method|||Week 2||30.7|-11.4|0.1663
70901711|NCT05375955|141291833|OTHER||Risk Difference (RD)|16.5||||0.0605|TWO_SIDED|95.0|-4.2|38.3|||Chan and Zhang (1999) method|||Week 2||38.3|-4.2|0.0605
70901712|NCT05375955|141291833|OTHER||Risk Difference (RD)|16.7||||0.0592|TWO_SIDED|95.0|-5.4|41.6|||Chan and Zhang (1999) method|||Week 2||41.6|-5.4|0.0592
70901713|NCT05375955|141291833|OTHER||Risk Difference (RD)|14.0||||0.1246|TWO_SIDED|95.0|-8.6|37.4|||Chan and Zhang (1999) method|||Week 4||37.4|-8.6|0.1246
70901714|NCT05375955|141291833|OTHER||Risk Difference (RD)|16.3||||0.0789|TWO_SIDED|95.0|-7.3|39.7|||Chan and Zhang (1999) method|||Week 4||39.7|-7.3|0.0789
70901715|NCT05375955|141291833|OTHER||Risk Difference (RD)|17.6||||0.0889|TWO_SIDED|95.0|-6.4|43.7|||Chan and Zhang (1999) method|||Week 4||43.7|-6.4|0.0889
70901716|NCT05375955|141291833|OTHER||Risk Difference (RD)|27.5||||0.0097|TWO_SIDED|95.0|4.2|50.7|||Chan and Zhang (1999) method|||Week 6||50.7|4.2|0.0097
70901717|NCT05375955|141291833|OTHER||Risk Difference (RD)|20.7||||0.0294|TWO_SIDED|95.0|-0.8|43.6|||Chan and Zhang (1999) method|||Week 6||43.6|-0.8|0.0294
70901718|NCT05375955|141291833|OTHER||Risk Difference (RD)|37.8||||0.0018|TWO_SIDED|95.0|10.9|62.2|||Chan and Zhang (1999) method|||Week 6||62.2|10.9|0.0018
70901719|NCT05375955|141291833|OTHER||Risk Difference (RD)|23.5||||0.0495|TWO_SIDED|95.0|-3.8|48.9|||Chan and Zhang (1999) method|||Week 8||48.9|-3.8|0.0495
70901720|NCT05375955|141291833|OTHER||Risk Difference (RD)|7.6||||0.289|TWO_SIDED|95.0|-17.3|32.4|||Chan and Zhang (1999) method|||Week 8||32.4|-17.3|0.2890
70901721|NCT05375955|141291833|OTHER||Risk Difference (RD)|35.2||||0.0103|TWO_SIDED|95.0|5.1|62.0|||Chan and Zhang (1999) method|||Week 8||62.0|5.1|0.0103
70901722|NCT05375955|141291833|OTHER||Risk Difference (RD)|19.0||||0.1088|TWO_SIDED|95.0|-7.8|44.8|||Chan and Zhang (1999) method|||Week 10||44.8|-7.8|0.1088
70901723|NCT05375955|141291833|OTHER||Risk Difference (RD)|11.8||||0.2719|TWO_SIDED|95.0|-14.0|36.2|||Chan and Zhang (1999) method|||Week 10||36.2|-14.0|0.2719
70901724|NCT05375955|141291833|OTHER||Risk Difference (RD)|30.0||||0.0227|TWO_SIDED|95.0|0.4|56.6|||Chan and Zhang (1999) method|||Week 10||56.6|0.4|0.0227
70901725|NCT05375955|141291833|OTHER||Risk Difference (RD)|23.5||||0.0495|TWO_SIDED|95.0|-3.8|48.9|||Chan and Zhang (1999) method|||Week 12||48.9|-3.8|0.0495
70901726|NCT05375955|141291833|OTHER||Risk Difference (RD)|15.9||||0.1246|TWO_SIDED|95.0|-10.6|40.6|||Chan and Zhang (1999) method|||Week 12||40.6|-10.6|0.1246
70901727|NCT05375955|141291833|OTHER||Risk Difference (RD)|30.0||||0.0227|TWO_SIDED|95.0|0.4|56.6|||Chan and Zhang (1999) method|||Week 12||56.6|0.4|0.0227
70901728|NCT01320943|141291841|SUPERIORITY|||||||0.022||||||Log-rank test statistic was used to compare the time to HBsAg loss between the two treatment arms.|Log Rank|||||||0.022
70901729|NCT00733980|141291848|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2479||||0.703||80.0|-0.5887|1.0846|||Mixed-Model Repeated-Measure analysis|||||1.0846|-0.5887|0.703
70901730|NCT00733980|141291849|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0169||||0.966|TWO_SIDED|80.0|-0.5231|0.4893|||Mixed Models Analysis|||GSK561679 Vs Placebo, Week 1||0.4893|-0.5231|0.966
70901731|NCT00733980|141291849|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4299||||0.386|TWO_SIDED|80.0|-0.2063|1.0661|||Mixed Models Analysis|||GSK561679 Vs Placebo, Week 2||1.0661|-0.2063|0.386
70901732|NCT00733980|141291849|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9413||||0.095|TWO_SIDED|80.0|0.2203|1.6624|||Mixed Models Analysis|||GSK561679 Vs Placebo, Week 4||1.6624|0.2203|0.095
70901733|NCT00733980|141291850|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9495||||0.209|TWO_SIDED|80.0|-0.0185|1.9175|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 1||1.9175|-0.0185|0.209
70901734|NCT00733980|141291850|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7638||||0.409|TWO_SIDED|80.0|-0.4243|1.9519|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 2||1.9519|-0.4243|0.409
70901735|NCT00733980|141291850|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5363||||0.156|TWO_SIDED|80.0|0.1485|2.9241|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 4||2.9241|0.1485|0.156
70901736|NCT00733980|141291850|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6327||||0.599|TWO_SIDED|80.0|-0.9135|2.1789|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 6||2.1789|-0.9135|0.599
70901737|NCT00733980|141291851|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9866||||0.181|TWO_SIDED|80.0|-3.8876|-0.0856|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 1||-0.0856|-3.8876|0.181
70901738|NCT00733980|141291851|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2538||||0.889|TWO_SIDED|80.0|-2.5922|2.0846|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 2||2.0846|-2.5922|0.889
70901739|NCT00733980|141291851|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3242||||0.867|TWO_SIDED|80.0|-2.8165|2.1681|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 3||2.1681|-2.8165|0.867
70901740|NCT00733980|141291851|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8107||||0.721|TWO_SIDED|80.0|-2.1036|3.7251|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 4||3.7251|-2.1036|0.721
70901741|NCT00733980|141291851|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6273||||0.801|TWO_SIDED|80.0|-3.8337|2.5791|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 6||2.5791|-3.8337|0.801
70901742|NCT00733980|141291852|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.644||||0.355|TWO_SIDED|80.0|-0.2498|1.5378|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 1||1.5378|-0.2498|0.355
70901743|NCT00733980|141291852|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0524||||0.249|TWO_SIDED|80.0|-0.1194|2.2243|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 2||2.2243|-0.1194|0.249
70901744|NCT00733980|141291852|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.6473||||0.116|TWO_SIDED|80.0|0.3078|2.9868|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 4||2.9868|0.3078|0.116
70901745|NCT00733980|141291852|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7283||||0.55|TWO_SIDED|80.0|-0.8353|2.292|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 6||2.2920|-0.8353|0.550
70901746|NCT00733980|141291856|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6359||||0.3588|TWO_SIDED|80.0|0.3378|1.1968|||Logistic Model|||GSK561679 350 mg Vs Placebo, Week 2||1.1968|0.3378|0.3588
70901747|NCT00733980|141291856|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7347||||0.4088|TWO_SIDED|80.0|0.4554|1.1853|||Logistic Model|||GSK561679 350 mg Vs Placebo, Week 4||1.1853|0.4554|0.4088
70901748|NCT00733980|141291856|SUPERIORITY_OR_OTHER||Logistic Model|0.9211||||0.8156|TWO_SIDED|80.0|0.5863|1.4471|||Logistic Model|||GSK561679 350 mg Vs Placebo, Week 6/ Early withdrawal||1.4471|0.5863|0.8156
70901749|NCT00733980|141291857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.4466||||0.361|TWO_SIDED|80.0|-1.3986|8.2917|||ANCOVA|||||8.2917|-1.3986|0.361
70901750|NCT00733980|141291858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1167||||0.932|TWO_SIDED|80.0|-1.6387|1.8722|||ANCOVA|||||1.8722|-1.6387|0.932
70901751|NCT00975221|141291897|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH) statistic|39.866|||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70901752|NCT00975221|141291898|SUPERIORITY_OR_OTHER||CMH statistic|40.953|||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70901753|NCT00975221|141291899|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-13.55|STANDARD_ERROR_OF_MEAN|1.34|<|0.001|TWO_SIDED|95.0|-16.23|-10.88|||ANCOVA|Analysis of covariance (ANCOVA) with baseline corrected serum calcium and baseline bisphosphonate included as covariates.|Treatment difference: cinacalcet-placebo|||-10.88|-16.23|<0.001
70901754|NCT00975221|141291900|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-22.79|STANDARD_ERROR_OF_MEAN|5.61|<|0.001|TWO_SIDED|95.0|-34.01|-11.57|||ANCOVA|Analysis of covariance (ANCOVA) with baseline corrected serum calcium and baseline bisphosphonate included as covariates.|Treatment difference: cinacalcet-placebo|||-11.57|-34.01|<0.001
70901755|NCT02790073|141291922|OTHER|Within group comparison vs baseline|||||<|0.001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.001
70901756|NCT02790073|141291923|OTHER|Within group comparison vs baseline||||||0.015|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.015
70901757|NCT02790073|141291924|OTHER|Within group comparison vs baseline||||||0.003|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.003
70901758|NCT02487498|141291933|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the lower limit (LL) of the 97.5% one -sided confidence interval (CI) \> -20 mL|Mean Difference (Net)|-0.0182|STANDARD_ERROR_OF_MEAN|0.00813||0.415|TWO_SIDED|95.0|-0.0342|-0.0023|||Linear Mixed Model|||Ho: QVA149 27.5/12.5 μg b.i.d. is inferior to umeclidinium/vilanterol 62.5/25 μg q.d; Ha: QVA149 27.5/12.5 μg b.i.d. is non-inferior to umeclidinium/vilanterol 62.5/25 μg q.d.||-0.0023|-0.0342|0.415
70901759|NCT02487498|141291934|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0182|STANDARD_ERROR_OF_MEAN|0.00813|||TWO_SIDED|95.0|-0.0342|-0.0023||||||||-0.0023|-0.0342|
70901760|NCT02487498|141291935|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0091|STANDARD_ERROR_OF_MEAN|0.01132|||TWO_SIDED|95.0|-0.0313|0.0131||||||||0.0131|-0.0313|
70901761|NCT02487498|141291936|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0086|STANDARD_ERROR_OF_MEAN|0.00874|||TWO_SIDED|95.0|-0.0086|0.0258||||||||0.0258|-0.0086|
70901762|NCT00676130|141291944|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.7|||<|0.05||95.0|-9.3|15.0|||Chi-squared|||The study was powered to detect a difference in cure rate of 98% in the intervention group vs. 85% in the control group, with 2-sided alpha 0.05. This would yield a number needed to treat of 7.7 for intervention vs. control, and required 144 subjects to achieve 80% power. No data were analyzed until study completion.||15|-9.3|<0.05
70901763|NCT00676130|141291945|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0|||<|0.05|TWO_SIDED|95.0|-6.5|6.3|||Chi-squared|||We assessed the rate of progression to abscess in the two groups.||6.3|-6.5|<0.05
70901764|NCT00755222|141291946|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|||||||0.001
70901765|NCT00755222|141291947|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||ANOVA|||||||0.046
70901766|NCT00755222|141291948|SUPERIORITY_OR_OTHER|||||||0.164|||||||ANOVA|||||||0.164
70901767|NCT00755222|141291949|SUPERIORITY_OR_OTHER|||||||0.442|||||||ANOVA|||||||0.442
70901768|NCT00755222|141291950|SUPERIORITY_OR_OTHER|||||||0.095|||||||ANOVA|||||||0.095
70901769|NCT02401464|141291964|NON_INFERIORITY_OR_EQUIVALENCE|Formulations were considered bioequivalent if: 1) 90% Cls of the differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.80)- ln(1.25);2) Differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.9)-ln(1.11),and results of the dissolution test met the conditions specified in the Guideline for Bioequivalence Studies of Generic Products.|Least Squares (LS) mean difference (ln)|0.963|||||TWO_SIDED|90.0|0.927|1.001||||||Based on the analysis of variance (ANOVA) in which the natural logarithms of AUC(0-48) of TAK-536 were used as dependent variables, and formulation, sequence (administration order) and administration period were used as fixed effects, bioequivalence was assessed providing two-sided 90% confidence intervals (CIs) for the differences between the formulations and between the periods.||1.001|0.927|
70901770|NCT02401464|141291965|NON_INFERIORITY_OR_EQUIVALENCE|Formulations were considered bioequivalent if: 1)90% Cls of the differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.80)- ln(1.25);2) Differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.9)-ln(1.11),and results of the dissolution test met the conditions specified in the Guideline for Bioequivalence Studies of Generic Products.|LS mean difference (ln)|0.906|||||TWO_SIDED|90.0|0.88|0.933||||||Based on the ANOVA in which the natural logarithms of Cmax of TAK-536 were used as dependent variables, and formulation, sequence (administration order) and administration period were used as fixed effects, bioequivalence was assessed providing two-sided 90% CIs for the differences between the formulations and between the periods.||0.933|0.880|
70901771|NCT02401464|141291966|NON_INFERIORITY_OR_EQUIVALENCE|Formulations were considered bioequivalent if: 1) 90% Cls of the differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.80)- ln(1.25);2) Differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.9)-ln(1.11),and results of the dissolution test met the conditions specified in the Guideline for Bioequivalence Studies of Generic Products.|LS mean difference (ln)|0.985|||||TWO_SIDED|90.0|0.958|1.011||||||Based on the ANOVA in which the natural logarithms of AUC(0-48) of TAK-536 were used as dependent variables, and formulation, sequence (administration order) and administration period were used as fixed effects, bioequivalence was assessed providing two-sided 90% CIs for the differences between the formulations and between the periods.||1.011|0.958|
70901772|NCT02401464|141291967|NON_INFERIORITY_OR_EQUIVALENCE|Formulations were considered bioequivalent if: 1) 90% Cls of the differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.80)- ln(1.25);2) Differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.9)-ln(1.11),and results of the dissolution test met the conditions specified in the Guideline for Bioequivalence Studies of Generic Products.|LS mean difference (ln)|0.979|||||TWO_SIDED|90.0|0.938|1.022||||||Based on the ANOVA in which the natural logarithms of Cmax of TAK-536 were used as dependent variables, and formulation, sequence (administration order) and administration period were used as fixed effects, bioequivalence was assessed providing two-sided 90% CIs for the differences between the formulations and between the periods.||1.022|0.938|
70901773|NCT03010462|141291995|SUPERIORITY|||||||0.62|||||||Chi-squared, Corrected|||||||0.62
70901774|NCT03010462|141291996|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
70901775|NCT03010462|141291997|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
70901776|NCT03010462|141291998|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||||||0.59
70901777|NCT03010462|141291999|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.70
70901778|NCT02207725|141292000|SUPERIORITY||Hodges-Lehman estimate of shift|-74.55|||<|0.0001|TWO_SIDED|95.0|-78.39|-66.28|||2-sided test exact Wilcoxon rank-sum tes|||||-66.28|-78.39|<0.0001
70901779|NCT02207725|141292000|SUPERIORITY||Hodges-Lehman estimate of shift|-59.5|||<|0.0001|TWO_SIDED|95.0|-64.1|-55.17|||2-sided test exact Wilcoxon rank-sum tes|||||-55.17|-64.10|<0.0001
70901780|NCT02207725|141292001|SUPERIORITY||Hodges-Lehman estimate of shift|-77.14|||<|0.0001|TWO_SIDED|95.0|-79.98|-74.04|||2-sided test exact Wilcoxon rank-sum tes|||||-74.04|-79.98|<0.0001
70901781|NCT02207725|141292003|SUPERIORITY||Hodges-Lehman estimate of shift|-7.09|||<|0.0001|TWO_SIDED|95.0|-8.86|-5.42|||2-sided test exact Wilcoxon rank-sum tes|||||-5.42|-8.86|<0.0001
70901782|NCT02207725|141292003|SUPERIORITY||Hodges-Lehman estimate of shift|-3.02||||0.0002|TWO_SIDED|95.0|-5.66|-1.25|||2-sided test exact Wilcoxon rank-sum tes|||||-1.25|-5.66|0.0002
70901783|NCT02207725|141292004|SUPERIORITY||Hodges-Lehman estimate of shift|1227.35|||<|0.0001|TWO_SIDED|95.0|984.01|1456.38|||2-sided test exact Wilcoxon rank-sum tes|||||1456.38|984.01|<0.0001
70901784|NCT02207725|141292004|SUPERIORITY||Hodges-Lehman estimate of shift|999.33|||<|0.0001|TWO_SIDED|95.0|819.5|1200.53|||2-sided test exact Wilcoxon rank-sum tes|||||1200.53|819.50|<0.0001
70901785|NCT00431184|141292030|SUPERIORITY_OR_OTHER|||||||0.22|||||||Mixed Models Analysis|||||||0.22
70901786|NCT00431184|141292031|SUPERIORITY_OR_OTHER|||||||0.83|||||||Mixed Models Analysis|||||||0.83
70901787|NCT04026165|141292062|SUPERIORITY||Difference in Adjusted Mean|1.2|STANDARD_ERROR_OF_MEAN|0.82||0.1439|TWO_SIDED|95.0|-0.41|2.81|||Random Slope Model|||Estimates were from a random slope model with change in eGFRcr from treatment-specific Baselines at Weeks 4, 8, 12, 24, 36, 48, 60, 72, and 84 as outcome, including terms for treatment-specific Baseline eGFRcr, pre-run-in urine albumin to creatinine ratio (UACR) category (\< 1500 mg/g vs. \>= 1500 mg/g), concomitant use of sodium-glucose co-transporter-2 (SGLT-2) inhibitors at Randomization, treatment group, week, and treatment-by-week interaction, where week has a random effect.||2.81|-0.41|0.1439
70901788|NCT04026165|141292063|SUPERIORITY||Difference in Percentage|0.1||||0.8353|TWO_SIDED|95.0|-10.9|11.4||p-value was based on Cochran-Mantel-Haenszel test stratified by Randomization stratification factors. Randomization stratification factors= pre-run-in eGFRcr stratum, pre-run-in UACR category and concomitant use of SGLT-2 inhibitors at Randomization.|Cochran-Mantel-Haenszel||95% exact CI based on the Santner-Snell method was presented for the difference in proportions between SEL and placebo arms.|||11.4|-10.9|0.8353
70901789|NCT04026165|141292064|SUPERIORITY||Hazard Ratio (HR)|1.48||||0.201|TWO_SIDED|95.0|0.81|2.72|||Stratified Log-Rank|P-value was calculated using a stratified log-rank test, stratified by randomization stratification factors.|Hazard ratio and 95% CI were estimated using a stratified Cox proportional hazard model, stratified by randomization stratification factors and were reported only for outcomes with more than 10 events, and have at least 1 event in each treatment arm.|||2.72|0.81|0.2010
70901790|NCT04026165|141292066|SUPERIORITY||Difference in Adjusted Mean|0.44|STANDARD_ERROR_OF_MEAN|0.72||0.5399|TWO_SIDED|95.0|-0.97|1.86|||Random Slope Model|||Estimates were from a random slope model with change in eGFRcys from pre-run-in Baseline at Weeks 4, 8, 12, 24, 36, 48, 60, 72, and 84 as outcome, including terms for pre-run-in Baseline eGFRcys, pre-run-in UACR category (\< 1500 mg/g vs. \>= 1500 mg/g), concomitant use of SGLT-2 inhibitors at Randomization, treatment group, week, and treatment-by-week interaction, where week has a random effect.||1.86|-0.97|0.5399
70901791|NCT03315936|141292105|OTHER||geometric mean (gMean) ratio (T/R) %|110.31|||||TWO_SIDED|90.0|100.73|120.79|||||To get, gMean ratio (T/R) and confidence interval, least square estimates of log-transformed PK endpoint for T and R were back transformed to original scale. Intra-individual geometric coefficient of variation (%) = 12.3.|The analysis of variance (ANOVA) model on the logarithmic scale including 'sequence', 'period', and 'treatment' as fixed effects and 'subject within sequence' as random effect. No hypothesis was tested and no acceptance range was specified. This was an intra-individual assessment and actually 12 subjects were analyzed||120.79|100.73|
70901792|NCT03315936|141292106|OTHER||gMean ratio (T/R) %|110.83|||||TWO_SIDED|90.0|101.2|121.38|||||To get, gMean ratio (T/R) and confidence interval, least square estimates of log-transformed PK endpoint for T and R were back transformed to original scale. Intra-individual geometric coefficient of variation (%) = 12.3.|The analysis of variance (ANOVA) model on the logarithmic scale including 'sequence', 'period', and 'treatment' as fixed effects and 'subject within sequence' as random effect. No hypothesis was tested and no acceptance range was specified. This was an intra-individual assessment and actually only 12 subjects were analyzed.||121.38|101.20|
70901793|NCT03315936|141292107|OTHER||gMean ratio (T/R) %|110.46|||||TWO_SIDED|90.0|89.74|135.96|||||To get, gMean ratio (T/R) and confidence interval, least square estimates of log-transformed PK endpoint for T and R were back transformed to original scale. Intra-individual geometric coefficient of variation (%) = 28.6.|The analysis of variance (ANOVA) model on the logarithmic scale including 'sequence', 'period', and 'treatment' as fixed effects and 'subject within sequence' as random effect. No hypothesis was tested and no acceptance range was specified. This was an intra-individual assessment and actually only 12 subjects were analyzed.||135.96|89.74|
70901794|NCT01674621|141292108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0066||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.0066
70901795|NCT01674621|141292108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.0005
70901796|NCT01674621|141292108|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||<0.0001
70901797|NCT01674621|141292108|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.93|||||TWO_SIDED|95.0|-5.555|-2.305|||||Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).|||-2.305|-5.555|
70901798|NCT01674621|141292108|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.47|||||TWO_SIDED|95.0|-5.104|-1.837|||||Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).|||-1.837|-5.104|
70901799|NCT01674621|141292108|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.856|||||TWO_SIDED|95.0|-4.519|-1.193|||||Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).|||-1.193|-4.519|
70901800|NCT01674621|141292109|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0547||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.0547
70901801|NCT01674621|141292109|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.0056
70901802|NCT01674621|141292109|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0018||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.0018
70901803|NCT01674621|141292109|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.768|||||TWO_SIDED|95.0|-2.864|-0.672|||||Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||-0.672|-2.864|
70901804|NCT01674621|141292109|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.42|||||TWO_SIDED|95.0|-2.522|-0.318|||||Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).|||-0.318|-2.522|
70901805|NCT01674621|141292109|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.247|||||TWO_SIDED|95.0|-2.368|-0.126|||||Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).|||-0.126|-2.368|
70901806|NCT01674621|141292110|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9493||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of treatment to each transdermal dose group versus placebo.||||||0.9493
70901807|NCT01674621|141292110|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9806||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of treatment to each transdermal dose group versus placebo.||||||0.9806
70901808|NCT01674621|141292110|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5191||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of treatment to each transdermal dose group versus placebo.||||||0.5191
70901809|NCT01674621|141292110|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.564|||||TWO_SIDED|95.0|-2.168|1.04|||||Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||1.040|-2.168|
70901810|NCT01674621|141292110|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.483|||||TWO_SIDED|95.0|-2.115|1.15|||||Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||1.150|-2.115|
70901811|NCT01674621|141292110|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.517|||||TWO_SIDED|95.0|-1.106|2.139|||||Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||2.139|-1.106|
70901812|NCT01674621|141292111|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2549||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BSAP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.2549
70901813|NCT01674621|141292111|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9115||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BSAP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.9115
70901814|NCT01674621|141292111|SUPERIORITY_OR_OTHER_LEGACY|||||||0.239||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BSAP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.2390
70901815|NCT01674621|141292111|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.146|||||TWO_SIDED|95.0|-40.501|-3.79|||||Mean difference of percent change from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||-3.790|-40.501|
70901816|NCT01674621|141292111|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.086|||||TWO_SIDED|95.0|-30.543|6.372|||||Mean difference of percent change from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||6.372|-30.543|
70901817|NCT01674621|141292111|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.828|||||TWO_SIDED|95.0|-41.614|-4.041|||||Mean difference of percent change from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||-4.041|-41.614|
70901818|NCT01674621|141292112|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1632||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PICP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.1632
70901819|NCT01674621|141292112|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9834||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PICP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.9834
70901820|NCT01674621|141292112|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2179||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PICP from baseline to end-of-treatment (EOT) to each transdermal dose group versus placebo.||||||0.2179
70901821|NCT01674621|141292112|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-27.541|||||TWO_SIDED|95.0|-48.557|-6.525|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-6.525|-48.557|
70901822|NCT01674621|141292112|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.702|||||TWO_SIDED|95.0|-39.835|2.43|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||2.430|-39.835|
70901823|NCT01674621|141292112|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.914|||||TWO_SIDED|95.0|-48.424|-5.405|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-5.405|-48.424|
70901824|NCT01674621|141292113|SUPERIORITY_OR_OTHER_LEGACY|||||||1||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of serum osteocalcin from baseline to EOT to each transdermal dose group versus placebo.||||||1.0000
70901825|NCT01674621|141292113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of serum osteocalcin from baseline to EOT to each transdermal dose group versus placebo.||||||0.1200
70901826|NCT01674621|141292113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9998||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of serum osteocalcin from baseline to EOT to each transdermal dose group versus placebo.||||||0.9998
70901827|NCT01674621|141292113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-73.906|||||TWO_SIDED|95.0|-96.926|-50.886|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-50.886|-96.926|
70901828|NCT01674621|141292113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-62.872|||||TWO_SIDED|95.0|-86.019|-39.725|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-39.725|-86.019|
70901829|NCT01674621|141292113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-73.367|||||TWO_SIDED|95.0|-96.927|-49.807|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-49.807|-96.927|
70901830|NCT01674621|141292114|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8569||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PINP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.8569
70901831|NCT01674621|141292114|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6091||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PINP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.6091
70901832|NCT01674621|141292114|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9999||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PINP from baseline to EOT to each transdermal dose group versus placebo.||||||0.9999
70901833|NCT01674621|141292114|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-110.398|||||TWO_SIDED|95.0|-156.966|-63.831|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-63.831|-156.966|
70901834|NCT01674621|141292114|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-96.115|||||TWO_SIDED|95.0|-142.94|-49.29|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-49.290|-142.940|
70901835|NCT01674621|141292114|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-104.418|||||TWO_SIDED|95.0|-152.079|-56.758|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-56.758|-152.079|
70901836|NCT01674621|141292115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3483||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of CTXI from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.3483
70901837|NCT01674621|141292115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6839||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of CTXI from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.6839
70901838|NCT01674621|141292115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1067||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of CTXI from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.1067
70901839|NCT01674621|141292115|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-43.721|||||TWO_SIDED|95.0|-75.748|-11.694|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-11.694|-75.748|
70901840|NCT01674621|141292115|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-39.461|||||TWO_SIDED|95.0|-71.665|-7.257|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-7.257|-71.665|
70901841|NCT01674621|141292115|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-49.334|||||TWO_SIDED|95.0|-82.113|-16.555|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-16.555|-82.113|
70901842|NCT01859793|141292122|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||Primary and secondary outcome variables were compared across measurement periods by repeated measures ANOVA and post hoc analyses using Tukey's test were applied if significant differences were detected. A priori sample size calculation demonstrated our study design has 80% power to detect a 1.5% absolute increase in FMD% with 30 subjects completing the entire study protocol at α=0.05.||||<0.05
70901843|NCT01859793|141292123|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||Outcome variables were compared across measurement periods by repeated measures ANOVA and post hoc analyses using Tukey's test were applied if significant differences were detected||||<0.05
70901844|NCT01859793|141292124|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||Outcome variables were compared across measurement periods by repeated measures ANOVA and post hoc analyses using Tukey's test were applied if significant differences were detected||||<0.05
70901845|NCT01148862|141292131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.2||||0.006|||||||ANCOVA|||||||0.006
70901846|NCT01148862|141292132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.015||95.0|||||ANCOVA|||||||0.015
70901847|NCT02404389|141292155|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|p value is provided|Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.07||0.515|TWO_SIDED|90.0|-0.12|0.12|||Posterior mean|||||0.12|-0.12|0.515
70901848|NCT02404389|141292155|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|p value is provided|Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.07||0.517|TWO_SIDED|90.0|-0.12|0.13|||posterior mean|||||0.13|-0.12|0.517
70901849|NCT00335257|141292161|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on a non-inferiority test of two exponential survival curves.These calculations are based on the following assumptions: 1) one-sided α 0.025; 2) power (1-β) of 0.90; 3) VTE incidence rate of 9/10.000 WY and 4) non-inferiority limit hazard ratio of 2. Furthermore, a study of this size would exclude a threefold risk of ATE.|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.5|1.3|||||Hazard ratio was adjusted for age, BMI, duration of current use, family history of VTE|Tested null hypotheses: the VTE hazard ratio for DRSP(24d) vs. Non-DRSP is higher or equal to 2||1.3|0.5|
70901850|NCT01412801|141292200|SUPERIORITY_OR_OTHER||Vaccine Group Ratios (Serotype Ia)|0.96|||||TWO_SIDED|98.4|0.71|1.3||||||||1.3|0.71|
70901851|NCT01412801|141292200|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype Ia)|0.81|||||TWO_SIDED|98.4|0.6|1.09||||||||1.09|0.6|
70901852|NCT01412801|141292200|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype Ia)|0.84|||||TWO_SIDED|98.4|0.63|1.14||||||||1.14|0.63|
70901853|NCT01412801|141292200|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype Ib)|0.8|||||TWO_SIDED|98.4|0.49|1.29||||||||1.29|0.49|
70901854|NCT01412801|141292200|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype Ib)|1.05|||||TWO_SIDED|98.4|0.65|1.69||||||||1.69|0.65|
70901855|NCT01412801|141292200|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype Ib)|1.32|||||TWO_SIDED|98.4|0.85|2.06||||||||2.06|0.85|
70901856|NCT01412801|141292200|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype III)|1.17|||||TWO_SIDED|98.4|0.66|2.07||||||||2.07|0.66|
70901857|NCT01412801|141292200|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype III)|1.06|||||TWO_SIDED|98.4|0.63|1.78||||||||1.78|0.63|
70901858|NCT01412801|141292200|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype III)|0.91|||||TWO_SIDED|98.4|0.52|1.58||||||||1.58|0.52|
70901859|NCT01987817|141292236|SUPERIORITY||Risk Difference (RD)|60.0|||<|0.0001|TWO_SIDED|95.0|35.0|79.0|||Fisher Exact|||||79|35|<0.0001
70901860|NCT01987817|141292237|SUPERIORITY||Treatment difference|0.912|||<|0.0001|TWO_SIDED|95.0|0.5184|1.3065||The p-value is based on the F-test for treatment effect adjusted for MTD from baseline (log10 mg). The p-value and confidence intervals are based on the normality assumption.|ANCOVA|Least squares means and 95% CIs based on ANCOVA model of change from baseline in MTD at Exit DBPCFC (terms for treatment \& MTD at baseline (log10 mg).||MTD for the baseline and Exit DBPCFC are transformed back to log10 scale before calculations. A value of 0.3 mg is substituted for subjects who could not tolerate the lowest DBPCFC dose before log10 transformation.||1.3065|0.5184|<0.0001
70901861|NCT01576718|141292242|SUPERIORITY_OR_OTHER|||||||0.0604||||||If the Fp MDPI showed a significantly positive trend, then contrasts for pairwise comparisons of each Fp MDPI dose versus placebo were done in the sequence of highest to lowest Fp MDPI dose.|Regression, Linear|||A linear in log-dose trend contrast was constructed to evaluate the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo). A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level. Specifically, the 2-sided linear in log-dose time-averaged trend test was first performed at the 0.05 level of significance.||||0.0604
70901862|NCT01576718|141292242|SUPERIORITY_OR_OTHER||LSM difference|0.072||||0.0637|TWO_SIDED|95.0|-0.004|0.149||Significance at the 0.05 level.|mixed model for repeated measures||Fp 400 - Placebo|No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||0.149|-0.004|0.0637
70901863|NCT01576718|141292242|SUPERIORITY_OR_OTHER||LSM difference|0.056||||0.1585|TWO_SIDED|95.0|-0.022|0.133||Significance at the 0.05 level|mixed model for repeated measures||Fp 200 - Placebo|No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||0.133|-0.022|0.1585
70901864|NCT01576718|141292242|SUPERIORITY_OR_OTHER||LSM difference|0.048||||0.2221|TWO_SIDED|95.0|-0.029|0.124||Significance at the 0.05 level|mixed model for repeated measures||Fp 100 - Placebo|No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||0.124|-0.029|0.2221
70901865|NCT01576718|141292242|SUPERIORITY_OR_OTHER||LSM difference|0.006|||=|0.8694|TWO_SIDED|95.0|-0.07|0.083||Significance at the 0.05 level|mixed model for repeated measures||Fp 50 - Placebo|No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||0.083|-0.070|=0.8694
70901866|NCT01576718|141292243|SUPERIORITY_OR_OTHER|||||||0.1512||||||If the Fp MDPI showed a significantly positive trend, then contrasts for pairwise comparisons of each Fp MDPI dose versus placebo were done in the sequence of highest to lowest Fp MDPI dose.|Regression, Linear|||A linear in log-dose trend contrast was constructed to evaluate the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo). A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level. Specifically, the 2-sided linear in log-dose time-averaged trend test was first performed at the 0.05 level of significance.||||0.1512
70901867|NCT01576718|141292243|SUPERIORITY_OR_OTHER||LSM difference|7.36||||0.2361|TWO_SIDED|95.0|-4.83|19.56||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||19.56|-4.83|0.2361
70901868|NCT01576718|141292243|SUPERIORITY_OR_OTHER||LSM difference|7.78||||0.2169|TWO_SIDED|95.0|-4.59|20.15|||Regression, Linear|Significance at the 0.05 level||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||20.15|-4.59|0.2169
70901869|NCT01576718|141292243|SUPERIORITY_OR_OTHER||LSM difference|7.09||||0.2523|TWO_SIDED|95.0|-5.07|19.26||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||19.26|-5.07|0.2523
70901870|NCT01576718|141292243|SUPERIORITY_OR_OTHER||LSM difference|8.23||||0.1858|TWO_SIDED|95.0|-3.98|20.45||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||20.45|-3.98|0.1858
70901871|NCT01576718|141292244|SUPERIORITY_OR_OTHER|||||||0.2879||||||If the Fp MDPI showed a significantly positive trend, then contrasts for pairwise comparisons of each Fp MDPI dose versus placebo were done in the sequence of highest to lowest Fp MDPI dose.|Regression, Linear|||A linear in log-dose trend contrast was constructed to evaluate the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo). A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level. Specifically, the 2-sided linear in log-dose time-averaged trend test was first performed at the 0.05 level of significance.||||0.2879
70901872|NCT01576718|141292244|SUPERIORITY_OR_OTHER||LSM difference|7.56||||0.2166|TWO_SIDED|95.0|-4.45|19.56||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||19.56|-4.45|0.2166
70901873|NCT01576718|141292244|SUPERIORITY_OR_OTHER||LSM difference|4.03||||0.5167|TWO_SIDED|95.0|-8.17|16.23||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||16.23|-8.17|0.5167
70901874|NCT01576718|141292244|SUPERIORITY_OR_OTHER||LSM difference|2.99||||0.6258|TWO_SIDED|95.0|-9.06|15.05||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||15.05|-9.06|0.6258
70901875|NCT01576718|141292244|SUPERIORITY_OR_OTHER||LSM difference|0.39||||0.9487|TWO_SIDED|95.0|-11.6|12.39||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||12.39|-11.60|0.9487
70901876|NCT01576718|141292245|SUPERIORITY_OR_OTHER|||||||0.0341||||||Significance level of 0.05.|Log Rank|||P-value for comparison of survival curve to placebo||||0.0341
70901877|NCT01576718|141292245|SUPERIORITY_OR_OTHER|||||||0.034||||||Significance level of 0.05.|Log Rank|||P-value for comparison of survival curve to placebo||||0.0340
70901878|NCT01576718|141292245|SUPERIORITY_OR_OTHER|||||||0.0058||||||Significance level of 0.05.|Log Rank|||P-value for comparison of survival curve to placebo||||0.0058
70901879|NCT01576718|141292245|SUPERIORITY_OR_OTHER|||||||0.0018||||||Significance level of 0.05.|Log Rank|||P-value for comparison of survival curve to placebo||||0.0018
70901880|NCT01576718|141292245|SUPERIORITY_OR_OTHER|||||||0.1006||||||Significance level of 0.05.|Log Rank|||P-value for comparison of survival curve to placebo||||0.1006
70901881|NCT01576718|141292246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.88116|TWO_SIDED|95.0|-11.12|12.91||Significance at the 0.05 level|Regression, Linear|||Estimates computed from a generalized linear logistic model with gender and age as covariates and allows correlation between estimates on the same subject. Interpretation of the estimates is that they are the average over the population at the average level of continuous covariate (age) averaged over discrete covariate (gender).||12.91|-11.12|0.88116
70901882|NCT01576718|141292246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.98||||0.05977|TWO_SIDED|95.0|-22.64|0.68||Significance at the 0.05 level|Regression, Linear|||Estimates computed from a generalized linear logistic model with gender and age as covariates and allows correlation between estimates on the same subject. Interpretation of the estimates is that they are the average over the population at the average level of continuous covariate (age) averaged over discrete covariate (gender).||0.68|-22.64|0.05977
70901883|NCT01576718|141292246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74||||0.90426|TWO_SIDED|95.0|-13.02|11.54||Significance at the 0.05 level|Regression, Linear|||Estimates computed from a generalized linear logistic model with gender and age as covariates and allows correlation between estimates on the same subject. Interpretation of the estimates is that they are the average over the population at the average level of continuous covariate (age) averaged over discrete covariate (gender).||11.54|-13.02|0.90426
70901884|NCT01576718|141292246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.38||||0.4731|TWO_SIDED|95.0|-16.57|7.82||Significance at the 0.05 level|Regression, Linear|||Estimates computed from a generalized linear logistic model with gender and age as covariates and allows correlation between estimates on the same subject. Interpretation of the estimates is that they are the average over the population at the average level of continuous covariate (age) averaged over discrete covariate (gender).||7.82|-16.57|0.47310
70901885|NCT01576718|141292253|SUPERIORITY_OR_OTHER||LSM difference|0.019|||=|0.6161|TWO_SIDED|95.0|-0.057|0.096||0.05 level of significance.|mixed model for repeated measures|||||0.096|-0.057|=0.6161
70901886|NCT01576718|141292253|SUPERIORITY_OR_OTHER||LSM difference|0.004||||0.9245|TWO_SIDED|95.0|-0.973|0.08||0.05 level of significance.|mixed model for repeated measures|||||0.080|-0.973|0.9245
70901887|NCT01576718|141292253|SUPERIORITY_OR_OTHER||LSM difference|-0.008||||0.8434|TWO_SIDED|95.0|-0.083|0.068||0.05 level of significance.|mixed model for repeated measures|||||0.068|-0.083|0.8434
70901888|NCT01576718|141292253|SUPERIORITY_OR_OTHER||LSM difference|-0.047||||0.2241|TWO_SIDED|95.0|-0.122|0.029||0.05 level of significance.|mixed model for repeated measures|||||0.029|-0.122|0.2241
70901889|NCT01576718|141292253|SUPERIORITY_OR_OTHER||LSM difference|-0.053||||0.1822|TWO_SIDED|95.0|-0.13|0.025||0.05 level of significance.|mixed model for repeated measures|||||0.025|-0.130|0.1822
70901890|NCT01576718|141292254|SUPERIORITY_OR_OTHER||LSM difference|-5.56||||0.3568|TWO_SIDED|95.0|-17.42|6.29||0.05 level of significance.|Regression, Linear|||||6.29|-17.42|0.3568
70901891|NCT01576718|141292254|SUPERIORITY_OR_OTHER||LSM difference|-5.68||||0.3531|TWO_SIDED|95.0|-17.67|6.32||0.05 level of significance.|Regression, Linear|||||6.32|-17.67|0.3531
70901892|NCT01576718|141292254|SUPERIORITY_OR_OTHER||LSM difference|-6.58||||0.2724|TWO_SIDED|95.0|-18.35|5.19||0.05 level of significance.|Regression, Linear|||||5.19|-18.35|0.2724
70901893|NCT01576718|141292254|SUPERIORITY_OR_OTHER||LSM difference|-5.11|||=|0.3964|TWO_SIDED|95.0|-16.95|6.72||0.05 level of significance.|Regression, Linear|||||6.72|-16.95|=0.3964
70901894|NCT01576718|141292254|SUPERIORITY_OR_OTHER||LSM difference|-13.45||||0.0296|TWO_SIDED|95.0|-25.57|-1.33||0.05 level of significance.|Regression, Linear|||||-1.33|-25.57|0.0296
70901895|NCT01576718|141292255|SUPERIORITY_OR_OTHER||LSM difference|-0.69||||0.9101|TWO_SIDED|95.0|-12.59|11.22||0.05 level of significance.|Regression, Linear|||||11.22|-12.59|0.9101
70901896|NCT01576718|141292255|SUPERIORITY_OR_OTHER||LSM difference|-4.51||||0.4634|TWO_SIDED|95.0|-16.6|7.57||0.05 level of significance.|Regression, Linear|||||7.57|-16.6|0.4634
70901897|NCT01576718|141292255|SUPERIORITY_OR_OTHER||LSM difference|-5.88||||0.3333|TWO_SIDED|95.0|-17.8|6.05||0.05 level of significance.|Regression, Linear|||||6.05|-17.8|0.3333
70901898|NCT01576718|141292255|SUPERIORITY_OR_OTHER||LSM difference|-8.19||||0.1763|TWO_SIDED|95.0|-20.06|3.69||0.05 level of significance.|Regression, Linear|||||3.69|-20.06|0.1763
70901899|NCT01576718|141292255|SUPERIORITY_OR_OTHER||Slope|-9.05||||0.1469|TWO_SIDED|95.0|-21.3|3.19||0.05 level of significance.|Regression, Linear|||||3.19|-21.3|0.1469
70901900|NCT01742364|141292299|SUPERIORITY_OR_OTHER|||||||0.475|||||||Fisher Exact|||Comparison of all adverse events (both injection site and systemic AEs).||||0.475
70901901|NCT01742364|141292299|SUPERIORITY_OR_OTHER|||||||0.187|||||||Fisher Exact|||Comparison of all adverse events (both injection site and systemic AEs).||||0.187
70901902|NCT01742364|141292301|SUPERIORITY_OR_OTHER|||||||0.205|||||||Wilcoxon (Mann-Whitney)|||||||0.205
70901903|NCT01742364|141292302|SUPERIORITY_OR_OTHER|||||||0.325|||||||Wilcoxon (Mann-Whitney)|||||||0.325
70901904|NCT01742364|141292303|SUPERIORITY_OR_OTHER|||||||0.001|||||||Kruskal-Wallis|||||||0.001
70901905|NCT01742364|141292303|SUPERIORITY_OR_OTHER|||||||0.13|||||||Kruskal-Wallis|||||||0.130
70901906|NCT01742364|141292304|SUPERIORITY_OR_OTHER|||||||0.001|||||||Chi-squared|||||||0.001
70901907|NCT01742364|141292304|SUPERIORITY_OR_OTHER|||||||0.003|||||||Chi-squared|||||||0.003
70901908|NCT00682643|141292305|SUPERIORITY_OR_OTHER|||||||0.395||95.0||||Wald Chi-Square test based on a proportional hazards model adjusting for age and baseline value|Wald Chi-square|||||||0.395
70901909|NCT00682643|141292306|SUPERIORITY_OR_OTHER|||||||0.342||95.0||||Wald Chi-Square test based on a proportional hazards model adjusting for age and baseline value|Wald Chi-square|||||||0.342
70901910|NCT04512066|141292380|OTHER||treatment effect|0.6||||0.849|TWO_SIDED|90.0|-4.58|5.78|||Mixed Models Analysis|||||5.78|-4.58|0.849
70901911|NCT04512066|141292380|OTHER||treatment effect|-2.83||||0.362|TWO_SIDED|90.0|-7.96|2.29|||Mixed Models Analysis|||||2.29|-7.96|0.362
70901912|NCT04512066|141292380|OTHER||treatment effect|-10.45||||0.001|TWO_SIDED|90.0|-15.46|-5.43|||Mixed Models Analysis|||||-5.43|-15.46|0.001
70901913|NCT00332332|141292429|SUPERIORITY_OR_OTHER||Percentage of participants|73.5||||||95.0|67.2|79.1||||||||79.1|67.2|
70901914|NCT02801669|141292454|OTHER||Cox Proportional Hazard|0.339||||0.0003|TWO_SIDED|95.0|0.188|0.608|||Regression, Cox|The treatment groups were compared using a Cox proportional hazard model with the CHADS2 score (\<= 2 or \>= 3) as covariate.||This statistical analysis assesses the annual incidence of composite event of stroke and SEE between treatment groups.||0.608|0.188|0.0003
70901915|NCT02801669|141292455|OTHER||Cox Proportional Hazard|0.299|||||TWO_SIDED|95.0|0.157|0.57|||||The treatment groups were compared using a Cox proportional hazard model with the CHADS2 score (\<= 2 or \>= 3) as covariate.|This statistical analysis assesses the annual incidence of stroke between treatment groups.||0.570|0.157|
70901916|NCT02801669|141292455|OTHER||Cox Proportional Hazard|0.503|||||TWO_SIDED|95.0|0.126|2.011|||||The treatment groups were compared using a Cox proportional hazard model with the CHADS2 score (\<= 2 or \>= 3) as covariate.|This statistical analysis assesses the annual incidence of SEE between treatment groups.||2.011|0.126|
70901917|NCT02801669|141292455|OTHER||Cox Proportional Hazard|0.306|||||TWO_SIDED|95.0|0.16|0.585|||||The treatment groups were compared using a Cox proportional hazard model with the CHADS2 score (\<= 2 or \>= 3) as covariate.|This statistical analysis assesses the annual incidence of ischemic stroke between treatment groups.||0.585|0.160|
70901918|NCT02801669|141292455|OTHER||Cox Proportional Hazard|0.347|||||TWO_SIDED|95.0|0.193|0.624|||||The treatment groups were compared using a Cox proportional hazard model with the CHADS2 score (\<= 2 or \>= 3) as covariate.|This statistical analysis assesses the annual incidence of ischemic stroke/SEE between treatment groups.||0.624|0.193|
70901919|NCT02696564|141292465|SUPERIORITY|We will estimate a 95% confidence interval for the losartan vs placebo mean difference, using the regression estimate and the t-distribution; we will reject the null that losartan is equivalent to placebo if the 95% interval excludes 0.0.||||||0.133|||||||Mixed Models Analysis|P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.||||||0.133
70901920|NCT02696564|141292466|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.762||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.762
70901921|NCT02696564|141292467|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.834||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.834
70901922|NCT02696564|141292468|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.783||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.783
70901923|NCT02696564|141292469|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.053||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.053
70901924|NCT02696564|141292470|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.016||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.016
70901925|NCT02696564|141292471|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.065||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.065
70901926|NCT02696564|141292472|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.293||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.293
70901927|NCT02696564|141292473|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.356||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.356
70901928|NCT02696564|141292474|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.009||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.009
70901929|NCT02696564|141292475|SUPERIORITY||Relative rate (losartan to placebo)|0.8||||0.892|TWO_SIDED|95.0|0.03|18.77|||Negative binomial model|||P-value for rate of mild exacerbations between treatment groups (measured in events per 100 person-years).||18.77|0.03|0.892
70901930|NCT02696564|141292475|SUPERIORITY||Relative rate (losartan to placebo)|0.91||||0.946|TWO_SIDED|95.0|0.05|14.97|||Negative binomial model|||P-value for rate of moderate exacerbations between treatment groups (measured in events per 100 person-years).||14.97|0.05|0.946
70901931|NCT02696564|141292475|SUPERIORITY||Relative rate (losartan to placebo)|0.36||||0.487|TWO_SIDED|95.0|0.02|6.51|||Negative binomial model|||P-value for rate of severe exacerbations between treatment groups (measured in events per 100 person-years).||6.51|0.02|0.487
70901932|NCT00615264|141292479|SUPERIORITY_OR_OTHER|||||||0.2851|||||||Mixed Models Analysis|Calculated with terms for treatment, visit, treatment by visit interaction, baseline C-peptide and country with the unstructured option for the matrix||||||0.2851
70901933|NCT00615264|141292480|SUPERIORITY_OR_OTHER|||||||0.769|||||||Mixed Models Analysis|Calculated with terms for treatment, visit, treatment by visit interaction, baseline C-peptide and country with the unstructured option for the matrix||||||0.7690
70901934|NCT00985985|141292529|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.3851|TWO_SIDED|95.0|0.78|1.92|||Cochran-Mantel-Haenszel||Odds Ratio based on logistic model (adjusted by center)|Null hypothesis considered no treatment difference in the smoking cessation success rate for the active treatment versus its matching placebo.||1.92|0.78|0.3851
70901935|NCT00985985|141292529|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.82||||0.0565|TWO_SIDED|95.0|0.99|3.32|||Cochran-Mantel-Haenszel||Odds Ratio based on logistic model (adjusted by center).|Null hypothesis considered no treatment difference in the smoking cessation success rate for the active treatment versus its matching placebo.||3.32|0.99|0.0565
70901936|NCT00509236|141292537|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Model terms: treatment, prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent), and a covariate for baseline A1c.||||<0.001
70901937|NCT00509236|141292538|SUPERIORITY_OR_OTHER||Difference in % Affected|-4.8||||0.336|TWO_SIDED|95.0|-15.7|5.6||Miettinen \& Nurminen method stratified by prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent).|Miettinen & Nurminen|||||5.6|-15.7|0.336
70901938|NCT00509236|141292539|SUPERIORITY_OR_OTHER||Difference in % Affected|2.8|||||TWO_SIDED|95.0|-10.9|16.5||||||||16.5|-10.9|
70901939|NCT00509236|141292540|SUPERIORITY_OR_OTHER||Change from Baseline in LS Mean|-26.6|||<|0.001|TWO_SIDED|95.0|-38.0|-15.3|||ANCOVA|||Model terms: treatment, prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent), and a covariate for baseline FPG.||-15.3|-38.0|<0.001
70901940|NCT00509236|141292540|SUPERIORITY_OR_OTHER||Change from Baseline in LS Mean|-31.2|||<|0.001|TWO_SIDED|95.0|-42.6|-19.9|||ANCOVA|||Model terms: treatment, prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent), and a covariate for baseline FPG.||-19.9|-42.6|<0.001
70901941|NCT00509236|141292540|SUPERIORITY_OR_OTHER||Difference in LS Means|4.6|||||TWO_SIDED|95.0|-11.5|20.7||||||Model terms: treatment, prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent), and a covariate for baseline FPG.||20.7|-11.5|
70901942|NCT00509236|141292541|SUPERIORITY_OR_OTHER||Difference in LS Means|0.15|||||TWO_SIDED|95.0|-0.18|0.49|||ANCOVA|||Model terms: treatment, prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent), and a covariate for baseline A1c.||0.49|-0.18|
70901943|NCT03587142|141292547|SUPERIORITY||Mean Difference (Net)|-0.11||||0.69|TWO_SIDED|95.0|-0.68|0.45||Nominal P value. Power was determined at a level of P=0.05.|ANCOVA|Multiple imputation using regression and 50 datasets to estimate the outcome for the 18/96 (19%) randomized patients without the f4 visit data.||Primary outcome analysis uses a difference of differences analysis between Buspirone compared to the Placebo arm in which the adjusted mean difference of differences, Wald 95% Confidence interval and 2-sided P values are determined from a Wald Chi-Square test. Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Negative change indicates symptom improvement.||0.45|-0.68|0.69
70901944|NCT03587142|141292547|SUPERIORITY||Mean Difference (Net)|-0.13||||0.62|TWO_SIDED|95.0|-0.65|0.39||P value is nominal; no adjustments made from multiple comparisons. Bonferroni p-value for the 10 sensitivity outcomes is \<0.005.|ANCOVA|||Sensitivity analysis of change from a baseline in ES/PPF (Early Satiety/Postprandial Fullness subscore) using all completers: 39 participants in Buspirone arm, 39 participants in placebo arm.||0.39|-0.65|0.62
70901945|NCT03587142|141292547|SUPERIORITY||Mean Difference (Net)|-0.25||||0.62|TWO_SIDED|95.0|-0.89|0.38||P value is nominal; no adjustments made for multiple comparisons. Bonferroni p-value for the 10 sensitivity outcomes is \<0.005|ANCOVA|||Sensitivity analyses: change in ES/PPF in treatment adherent patients: 23 participants in Buspirone arm, 29 patients in placebo arm.||0.38|-0.89|0.62
70901946|NCT03587142|141292548|SUPERIORITY||Mean Difference (Net)|-0.09||||0.76|TWO_SIDED|95.0|-0.69|0.5||Nominal P value reported. Bonferroni p-value for the 10 sensitivity outcomes is \<0.005|ANCOVA|||The mean difference of differences (DoD) between Buspirone and Placebo, 95% confidence interval and P (2-sided) were derived from an ANCOVA, regressing an indicator for treatment group on fullness severity score, adjusting for the baseline value of fullness severity score.||0.50|-0.69|0.76
70901947|NCT03587142|141292549|SUPERIORITY||Mean Difference (Net)|-0.15||||0.64|TWO_SIDED|95.0|-0.76|0.47||Nominal P values; Bonferroni p value for the 10 sensitivity outcomes is \<0.005|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.47|-0.76|0.64
70901948|NCT03587142|141292550|SUPERIORITY||Mean Difference (Net)|-0.14||||0.66|TWO_SIDED|95.0|-0.79|0.5||P values are nominal; Bonferroni p-value for the 10 sensitivity outcomes is \<0.005|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.50|-0.79|0.66
70901949|NCT03587142|141292551|SUPERIORITY||Mean Difference (Net)|-0.12||||0.7|TWO_SIDED|95.0|-0.75|0.5||Nominal P values; Bonferroni p-value for the 10 sensitivity outcomes is \<0.005|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (s-sided) determined from a Wald Chi-Square test.||0.50|-0.75|0.70
70901950|NCT03587142|141292552|SUPERIORITY||Mean Difference (Net)|-0.2||||0.4|TWO_SIDED|95.0|-0.66|0.27||P value is nominal; no adjustments made for multiple comparisons. Bonferrini p-value is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) of change in outcome from baseline and 95% Confidence Intervals were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. P (2-sided) were determined from a Wald Chi-Square test.||0.27|-0.66|0.40
70901951|NCT03587142|141292552|SUPERIORITY||Odds Ratio (OR)|1.31||||0.56|TWO_SIDED|95.0|0.53|3.21||Nominal P value without adjustment for multiple comparisons. Bonferroni threshold for level of significance is \<0.002.|Regression, Logistic|Odds ratio, 95% C.I. and P (two-sided) from a logistic regression of the binary outcome on treatment group for symptomatic improvement in GCSI.||GCSI symptomatic improvement of 1+ points in total GCSI symptom score defined as change in GCSI total score at week 4 from baseline being a decrease of 1 or more points. This is a binary variable where 1=1+ reduction in change in GCSI total score, 0=change in GCSI total score from baseline at 4-weeks is \< 1.0.||3.21|0.53|0.56
70901952|NCT03587142|141292553|SUPERIORITY||Mean Difference (Net)|-0.05||||0.86|TWO_SIDED|95.0|-0.58|0.48||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Squares test.||0.48|-0.58|0.86
70901953|NCT03587142|141292554|SUPERIORITY||Mean Difference (Net)|-0.06||||0.85|TWO_SIDED|95.0|-0.64|0.53||P value is nominal; no adjustments made for multiple comparisons. Bonferroni p-value is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald-Chi Square test.||0.53|-0.64|0.85
70901954|NCT03587142|141292555|SUPERIORITY||Mean Difference (Net)|-0.14||||0.65|TWO_SIDED|95.0|-0.76|0.47||P value is nominal; no adjustments made for multiple comparisons. Bonferroni p-value is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test||0.47|-0.76|0.65
70901955|NCT03587142|141292556|SUPERIORITY||Mean Difference (Net)|-0.41||||0.16|TWO_SIDED|95.0|-0.99|0.16||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.16|-0.99|0.16
70901956|NCT03587142|141292557|SUPERIORITY||Mean Difference (Net)|-0.65||||0.03|TWO_SIDED|95.0|-1.23|-0.08||P values are nominal; no adjustments made for multiple comparisons.|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||-0.08|-1.23|0.03
70901957|NCT03587142|141292558|SUPERIORITY||Mean Difference (Net)|0.17||||0.59|TWO_SIDED|95.0|-0.44|0.77||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.77|-0.44|0.59
70901958|NCT03587142|141292559|SUPERIORITY||Mean Difference (Net)|0.24||||0.46|TWO_SIDED|95.0|-0.39|0.88||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.88|-0.39|0.46
70901959|NCT03587142|141292560|SUPERIORITY||Mean Difference (Net)|0.09||||0.73|TWO_SIDED|95.0|-0.42|0.59||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.59|-0.42|0.73
70901960|NCT03587142|141292561|SUPERIORITY||Mean Difference (Net)|-0.14||||0.5|TWO_SIDED|95.0|-0.55|0.27||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.27|-0.55|0.50
70901961|NCT03587142|141292562|SUPERIORITY||Mean Difference (Net)|0.32||||0.18|TWO_SIDED|95.0|-0.15|0.79||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.79|-0.15|0.18
70901962|NCT03587142|141292563|SUPERIORITY||Mean Difference (Net)|1.01||||0.19|TWO_SIDED|95.0|-0.49|2.51||P value is nominal: no adjustments made from multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002.|ANCOVA|||Adjusted mean difference from differences (DoD) from the baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Intervals are reported; P value (2-sided) determined from a Wald Chi-Square test.||2.51|-0.49|0.19
70901963|NCT03587142|141292564|SUPERIORITY||Mean Difference (Net)|1.86||||0.02|TWO_SIDED|95.0|0.33|3.38||P value is nominal: no adjustments made for multiple comparisons. Bonferroni P-value threshold for the level of significance is \<=0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the HADS depression score.||3.38|0.33|0.02
70901964|NCT03587142|141292565|SUPERIORITY||Mean Difference (Net)|0.76||||0.4|TWO_SIDED|95.0|-1.02|2.54||P values are nominal; no adjustments for multiple comparisons|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the HADS anxiety total score. 95% Wald Confidence Intervals are reported; P (2-sided) determined from a Wald Chi-Square test||2.54|-1.02|0.40
70901965|NCT03587142|141292566|SUPERIORITY||Mean Difference (Net)|-0.21||||0.25|TWO_SIDED|95.0|-0.57|0.15||P value is nominal with no adjustment for multiple comparisons. The Bonferroni level of significance threshold is \<=0.002.|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of PAGI-QOL total score.||0.15|-0.57|0.25
70901966|NCT03587142|141292567|SUPERIORITY||Mean Difference (Net)|-1.98||||0.36|TWO_SIDED|95.0|-6.2|2.24|||ANCOVA|||Adjusted mean difference of differences (DoD) of change in outcome from baseline and 95% Confidence Intervals were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of outcome. P (2-sided) were determined from a Wald-Chi-Square test.||2.24|-6.20|0.36
70901967|NCT03587142|141292568|SUPERIORITY||Mean Difference (Net)|-2.07||||0.15|TWO_SIDED|95.0|-4.91|0.76||P value is nominal; no adjustments made for multiple comparisons Bonferroni p-value is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.76|-4.91|0.15
70901968|NCT03587142|141292569|SUPERIORITY||Mean Difference (Net)|1.37||||0.76|TWO_SIDED|95.0|-7.51|10.25||P value is nominal: no adjustments made for multiple comparisons. Bonferrini p-value is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Intervals are reported. P (2-sided) determined from a Wald Chi-Square test.||10.25|-7.51|0.76
70901969|NCT03587142|141292570|SUPERIORITY||Mean Difference (Net)|-0.05||||0.1|TWO_SIDED|95.0|-0.12|0.01||Nominal P values; no adjustment for multiple comparisons.|ANCOVA|||Adjusted mean difference of differences (DoD) were computed using ANCOVA, regressing change in IMD from baseline to 4-weeks on treatment group and the baseline value of IMD. Wald 95% Confidence Intervals are reported; P (2-sided) determined from a Wald Chi-Square test.||0.01|-0.12|0.10
70901970|NCT03587142|141292571|SUPERIORITY||Mean Difference (Net)|-21.51||||0.29|TWO_SIDED|95.0|-99.4|56.4||Nominal P values; no adjustments for multiple comparisons.|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of teh outcome. Wald 95% Confidence Limits are reported; P (2-sided) determined from a Wald Chi-Square test.||56.4|-99.4|0.29
70901971|NCT03587142|141292572|SUPERIORITY||Mean Difference (Net)|0.09||||0.84|TWO_SIDED|95.0|-0.78|0.95||P value is nominal; no adjustments made for multiple comparisons. Bonferroni p-value \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to week 4 on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported: P (2-sided) determined from Wald Chi-Square test.||0.95|-0.78|0.84
70901972|NCT03587142|141292573|SUPERIORITY||Mean Difference (Net)|-6.43||||0.27|TWO_SIDED|95.0|-17.9|5.03||P value is nominal|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||5.03|-17.90|0.27
70901973|NCT03587142|141292574|SUPERIORITY||Mean Difference (Net)|-1.02||||0.74|TWO_SIDED|95.0|-6.93|4.89||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Intervals are reported; P (2-sided) determined from a Wald Chi-Square test.||4.89|-6.93|0.74
70901974|NCT03587142|141292575|SUPERIORITY||Mean Difference (Net)|0.03||||0.18|TWO_SIDED|95.0|-0.01|0.08|||ANCOVA|P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold level of significance \<0.002||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. 95% Wald Confidence Intervals are reported; P (2-sided) determined from a Wald Chi-Square test.||0.08|-0.01|0.18
70901975|NCT03587142|141292576|SUPERIORITY||Mean Difference (Net)|-0.39||||0.97|TWO_SIDED|95.0|-20.42|19.64||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. 95% Wald Confidence Intervals are reported; P (2-sided) determined from a Wald Chi-Square test.||19.64|-20.42|0.97
70901976|NCT03587142|141292577|SUPERIORITY||Incident rate ratio|1.27||||0.64|TWO_SIDED|95.0|0.57|2.82||P values are nominal and not adjusted for multiple comparisons.|Exact poisson regression|||Event rates are computed by treatment arm by dividing the total adverse events over 4-weeks by the number of patient-months of follow-up to 4-weeks. Event rates are compared by treatment arm using an exact poisson regression for event rates.||2.82|0.57|0.64
70901977|NCT03587142|141292578|SUPERIORITY||Incident rate ratio|0.95||||0.54|TWO_SIDED|95.0|0.35|2.62||P values are nominal.|Fisher Exact|||A Fisher's Exact test was used for comparisons of events by treatment by severity grade. One patient in the Buspirone arm had 2 AEs during the trial; for analysis by severity grade the maximum severity grade was used.|An exact poisson regression stratified by severity level was used to compute the incident rate ratio and 95% Confidence Intervals for adverse events by severity level.|2.62|0.35|0.54
70901978|NCT03587142|141292579|SUPERIORITY|||||||1||||||P value is nominal.|Fisher Exact|||||||1.00
70901979|NCT03587142|141292580|SUPERIORITY||Incident rate ratio|1.03||||1|TWO_SIDED|95.0|0.0|40.36||P-values are nominal.|Exact poisson regression|||Event rates were computed by dividing the number of hospitalizations over 4-weeks by the number of person-years. An exact poisson regression was used to compare events by treatment group.||40.36|0|1.00
70901980|NCT03587142|141292581|SUPERIORITY|||||||0.52||||||Nominal P value.|Binomial probability test|2-sided test with probability of success=0||||||0.52
70901981|NCT03502616|141292589|SUPERIORITY||Difference in percentage|27.08|STANDARD_ERROR_OF_MEAN|5.71|<|0.0001|TWO_SIDED|95.0|15.89|38.28|||Cochran-Mantel-Haenszel|||Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via Cochran-Mantel-Haenszel (CMH) approach.||38.28|15.89|<0.0001
70901982|NCT03502616|141292590|SUPERIORITY||Difference in percentage|28.17|STANDARD_ERROR_OF_MEAN|5.06|<|0.0001|TWO_SIDED|95.0|18.26|38.09|||Cochran-Mantel-Haenszel|||Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||38.09|18.26|<0.0001
70901983|NCT03502616|141292597|SUPERIORITY||Difference in percentage|18.28|STANDARD_ERROR_OF_MEAN|4.7||0.0001|TWO_SIDED|95.0|9.06|27.5|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||27.50|9.06|0.0001
70901984|NCT03502616|141292597|SUPERIORITY||Difference in percentage|31.35|STANDARD_ERROR_OF_MEAN|5.47|<|0.0001|TWO_SIDED|95.0|20.64|42.06|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||42.06|20.64|<0.0001
70901985|NCT03502616|141292597|SUPERIORITY||Difference in percentage|32.24|STANDARD_ERROR_OF_MEAN|5.57|<|0.0001|TWO_SIDED|95.0|21.32|43.17|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||43.17|21.32|<0.0001
70901986|NCT03502616|141292597|SUPERIORITY||Difference in percentage|34.61|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001|TWO_SIDED|95.0|23.63|45.58|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||45.58|23.63|<0.0001
70901987|NCT03502616|141292597|SUPERIORITY||Difference in percentage|3.65|STANDARD_ERROR_OF_MEAN|5.9||0.536|TWO_SIDED|95.0|-7.92|15.22|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||15.22|-7.92|0.5360
70901988|NCT03502616|141292597|SUPERIORITY||Difference in percentage|3.83|STANDARD_ERROR_OF_MEAN|5.63||0.4971|TWO_SIDED|95.0|-7.22|14.87|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||14.87|-7.22|0.4971
70901989|NCT03502616|141292597|SUPERIORITY||Difference in percentage|1.58|STANDARD_ERROR_OF_MEAN|5.65||0.7792|TWO_SIDED|95.0|-9.49|12.66|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||12.66|-9.49|0.7792
70901990|NCT03502616|141292597|SUPERIORITY||Difference in percentage|5.22|STANDARD_ERROR_OF_MEAN|5.8||0.3685|TWO_SIDED|95.0|-6.15|16.58|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||16.58|-6.15|0.3685
70901991|NCT03502616|141292598|SUPERIORITY||Difference in percentage|6.12|STANDARD_ERROR_OF_MEAN|3.19||0.0548|TWO_SIDED|95.0|-0.13|12.37|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||12.37|-0.13|0.0548
70901992|NCT03502616|141292598|SUPERIORITY||Difference in percentage|23.43|STANDARD_ERROR_OF_MEAN|4.15|<|0.0001|TWO_SIDED|95.0|15.3|31.56|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||31.56|15.30|<0.0001
70901993|NCT03502616|141292598|SUPERIORITY||Difference in percentage|28.56|STANDARD_ERROR_OF_MEAN|4.54|<|0.0001|TWO_SIDED|95.0|19.66|37.47|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||37.47|19.66|<0.0001
70901994|NCT03502616|141292598|SUPERIORITY||Difference in percentage|31.18|STANDARD_ERROR_OF_MEAN|5.02|<|0.0001|TWO_SIDED|95.0|21.34|41.02|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||41.02|21.34|<0.0001
70901995|NCT03502616|141292598|SUPERIORITY||Difference in percentage|6.29|STANDARD_ERROR_OF_MEAN|5.98||0.2926|TWO_SIDED|95.0|-5.43|18.01|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||18.01|-5.43|0.2926
70901996|NCT03502616|141292598|SUPERIORITY||Difference in percentage|6.37|STANDARD_ERROR_OF_MEAN|5.97||0.2856|TWO_SIDED|95.0|-5.32|18.06|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||18.06|-5.32|0.2856
70901997|NCT03502616|141292598|SUPERIORITY||Difference in percentage|7.83|STANDARD_ERROR_OF_MEAN|5.97||0.1894|TWO_SIDED|95.0|-3.87|19.54|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach||19.54|-3.87|0.1894
70901998|NCT03502616|141292598|SUPERIORITY||Difference in percentage|5.59|STANDARD_ERROR_OF_MEAN|6.04||0.3544|TWO_SIDED|95.0|-6.24|17.43|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach||17.43|-6.24|0.3544
70901999|NCT03502616|141292599|SUPERIORITY||LS mean difference|-0.71|STANDARD_ERROR_OF_MEAN|0.072|<|0.0001|TWO_SIDED|95.0|-0.85|-0.57|||Mixed Models Analysis|||Week 2: Analysis performed using Mixed model for repeated measures (MMRM) which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.57|-0.85|<0.0001
70902000|NCT03502616|141292599|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.083|<|0.0001|TWO_SIDED|95.0|-1.07|-0.74|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.74|-1.07|<0.0001
70902001|NCT03502616|141292599|SUPERIORITY||LS mean difference|-1.06|STANDARD_ERROR_OF_MEAN|0.095|<|0.0001|TWO_SIDED|95.0|-1.25|-0.87|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.87|-1.25|<0.0001
70902002|NCT03502616|141292599|SUPERIORITY||LS mean difference|-1.09|STANDARD_ERROR_OF_MEAN|0.096|<|0.0001|TWO_SIDED|95.0|-1.28|-0.9|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.90|-1.28|<0.0001
70902003|NCT03502616|141292599|SUPERIORITY||LS mean difference|-0.98|STANDARD_ERROR_OF_MEAN|0.093|<|0.0001|TWO_SIDED|95.0|-1.16|-0.79|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.79|-1.16|<0.0001
70902004|NCT03502616|141292599|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.103||0.0623|TWO_SIDED|95.0|-0.4|0.01|||Mixed Models Analysis|||Week 24: Analysis performed using Mixed model for repeated measures (MMRM) which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.01|-0.40|0.0623
70902005|NCT03502616|141292599|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.106||0.0836|TWO_SIDED|95.0|-0.39|0.02|||Mixed Models Analysis|||Week 32: Analysis performed using Mixed model for repeated measures (MMRM) which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.02|-0.39|0.0836
70902006|NCT03502616|141292599|SUPERIORITY||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.108||0.0205|TWO_SIDED|95.0|-0.47|-0.04|||Mixed Models Analysis|||Week 40: Analysis performed using Mixed model for repeated measures (MMRM) which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.04|-0.47|0.0205
70902007|NCT03502616|141292599|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.108||0.0614|TWO_SIDED|95.0|-0.42|0.01|||Mixed Models Analysis|||Week 48: Analysis performed using Mixed model for repeated measures (MMRM) which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.01|-0.42|0.0614
70902008|NCT03502616|141292600|SUPERIORITY||LS mean difference|-0.93|STANDARD_ERROR_OF_MEAN|0.113|<|0.0001|TWO_SIDED|95.0|-1.15|-0.7|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.70|-1.15|<0.0001
70902009|NCT03502616|141292600|SUPERIORITY||LS mean difference|-0.92|STANDARD_ERROR_OF_MEAN|0.121|<|0.0001|TWO_SIDED|95.0|-1.16|-0.68|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.68|-1.16|<0.0001
70902010|NCT03502616|141292600|SUPERIORITY||LS mean difference|-1.02|STANDARD_ERROR_OF_MEAN|0.196|<|0.0001|TWO_SIDED|95.0|-1.4|-0.63|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.63|-1.40|<0.0001
70902011|NCT03502616|141292600|SUPERIORITY||LS mean difference|-0.96|STANDARD_ERROR_OF_MEAN|0.115|<|0.0001|TWO_SIDED|95.0|-1.19|-0.74|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.74|-1.19|<0.0001
70902012|NCT03502616|141292600|SUPERIORITY||LS mean difference|-0.96|STANDARD_ERROR_OF_MEAN|0.122|<|0.0001|TWO_SIDED|95.0|-1.2|-0.72|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.72|-1.20|<0.0001
70902013|NCT03502616|141292600|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.073||0.4731|TWO_SIDED|95.0|-0.2|0.09|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.09|-0.20|0.4731
70902014|NCT03502616|141292600|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.094||0.4055|TWO_SIDED|95.0|-0.26|0.11|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.11|-0.26|0.4055
70902015|NCT03502616|141292600|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.111||0.2648|TWO_SIDED|95.0|-0.34|0.09|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.09|-0.34|0.2648
70902016|NCT03502616|141292600|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.099||0.5558|TWO_SIDED|95.0|-0.25|0.14|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.14|-0.25|0.5558
70902017|NCT03502616|141292601|SUPERIORITY||LS mean difference|-2.02|STANDARD_ERROR_OF_MEAN|0.513||0.0001|TWO_SIDED|95.0|-3.03|-1.01|||ANCOVA|||Week 16: Analysis performed using Analysis of covariance (ANCOVA) model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||-1.01|-3.03|0.0001
70902018|NCT03502616|141292601|SUPERIORITY||LS mean difference|-1.26|STANDARD_ERROR_OF_MEAN|0.567||0.027|TWO_SIDED|95.0|-2.38|-0.14|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.14|-2.38|0.0270
70902019|NCT03502616|141292602|SUPERIORITY||LS mean difference|2.22|STANDARD_ERROR_OF_MEAN|0.841||0.0088|TWO_SIDED|95.0|0.56|3.88|||ANCOVA|||Week 16, Physical Functioning: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||3.88|0.56|0.0088
70902020|NCT03502616|141292602|SUPERIORITY||LS mean difference|3.0|STANDARD_ERROR_OF_MEAN|0.939||0.0016|TWO_SIDED|95.0|1.15|4.85|||ANCOVA|||Week 16, Role-Physical: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||4.85|1.15|0.0016
70902021|NCT03502616|141292602|SUPERIORITY||LS mean difference|4.46|STANDARD_ERROR_OF_MEAN|0.9|<|0.0001|TWO_SIDED|95.0|2.69|6.23|||ANCOVA|||Week 16, Bodily Pain: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||6.23|2.69|<0.0001
70902022|NCT03502616|141292602|SUPERIORITY||LS mean difference|3.24|STANDARD_ERROR_OF_MEAN|0.781|<|0.0001|TWO_SIDED|95.0|1.7|4.78|||ANCOVA|||Week 16, General Health: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||4.78|1.70|<0.0001
70902023|NCT03502616|141292602|SUPERIORITY||LS mean difference|1.78|STANDARD_ERROR_OF_MEAN|1.098||0.1065|TWO_SIDED|95.0|-0.38|3.94|||ANCOVA|||Week 16, Vitality: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||3.94|-0.38|0.1065
70902024|NCT03502616|141292602|SUPERIORITY||LS mean difference|2.96|STANDARD_ERROR_OF_MEAN|1.059||0.0055|TWO_SIDED|95.0|0.88|5.05|||ANCOVA|||Week 16, Social Functioning: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||5.05|0.88|0.0055
70902025|NCT03502616|141292602|SUPERIORITY||LS mean difference|2.08|STANDARD_ERROR_OF_MEAN|1.289||0.1084|TWO_SIDED|95.0|-0.46|4.61|||ANCOVA|||Week 16, Role-Emotional: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||4.61|-0.46|0.1084
70902026|NCT03502616|141292602|SUPERIORITY||LS mean difference|1.08|STANDARD_ERROR_OF_MEAN|1.124||0.3379|TWO_SIDED|95.0|-1.13|3.29|||ANCOVA|||Week 16, Mental Health: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||3.29|-1.13|0.3379
70902027|NCT03502616|141292602|SUPERIORITY||LS mean difference|3.55|STANDARD_ERROR_OF_MEAN|0.744|<|0.0001|TWO_SIDED|95.0|2.09|5.02|||ANCOVA|||Week 16, Physical Component Summary: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||5.02|2.09|<0.0001
70902028|NCT03502616|141292602|SUPERIORITY||LS mean difference|1.33|STANDARD_ERROR_OF_MEAN|1.158||0.2529|TWO_SIDED|95.0|-0.95|3.61|||ANCOVA|||Week 16, Mental Component Summary: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||3.61|-0.95|0.2529
70902029|NCT03502616|141292602|SUPERIORITY||LS mean difference|0.86|STANDARD_ERROR_OF_MEAN|0.964||0.3744|TWO_SIDED|95.0|-1.04|2.76|||Mixed Models Analysis|||Week 48, Physical Functioning: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.76|-1.04|0.3744
70902030|NCT03502616|141292602|SUPERIORITY||LS mean difference|1.36|STANDARD_ERROR_OF_MEAN|1.083||0.2091|TWO_SIDED|95.0|-0.77|3.5|||Mixed Models Analysis|||Week 48, Role-Physical: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.50|-0.77|0.2091
70902031|NCT03502616|141292602|SUPERIORITY||LS mean difference|2.12|STANDARD_ERROR_OF_MEAN|1.146||0.0654|TWO_SIDED|95.0|-0.14|4.38|||Mixed Models Analysis|||Week 48, Bodily Pain: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.38|-0.14|0.0654
70902032|NCT03502616|141292602|SUPERIORITY||LS mean difference|1.22|STANDARD_ERROR_OF_MEAN|0.968||0.21|TWO_SIDED|95.0|-0.69|3.12|||Mixed Models Analysis|||Week 48, General Health: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.12|-0.69|0.2100
70902033|NCT03502616|141292602|SUPERIORITY||LS mean difference|0.56|STANDARD_ERROR_OF_MEAN|1.248||0.6568|TWO_SIDED|95.0|-1.9|3.01|||Mixed Models Analysis|||Week 48, Vitality: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.01|-1.90|0.6568
70902034|NCT03502616|141292602|SUPERIORITY||LS mean difference|1.39|STANDARD_ERROR_OF_MEAN|1.152||0.2288|TWO_SIDED|95.0|-0.88|3.66|||Mixed Models Analysis|||Week 48, Social Functioning: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.66|-0.88|0.2288
70902035|NCT03502616|141292602|SUPERIORITY||LS mean difference|0.85|STANDARD_ERROR_OF_MEAN|1.25||0.4955|TWO_SIDED|95.0|-1.61|3.32|||Mixed Models Analysis|||Week 48, Role-Emotional: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.32|-1.61|0.4955
70902036|NCT03502616|141292602|SUPERIORITY||LS mean difference|0.65|STANDARD_ERROR_OF_MEAN|1.2||0.5888|TWO_SIDED|95.0|-1.71|3.01|||Mixed Models Analysis|||Week 48, Mental Health: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.01|-1.71|0.5888
70902037|NCT03502616|141292602|SUPERIORITY||LS mean difference|1.42|STANDARD_ERROR_OF_MEAN|0.896||0.115|TWO_SIDED|95.0|-0.35|3.18|||Mixed Models Analysis|||Week 48, Physical Component Summary: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.18|-0.35|0.1150
70902038|NCT03502616|141292602|SUPERIORITY||LS mean difference|0.72|STANDARD_ERROR_OF_MEAN|1.158||0.5347|TWO_SIDED|95.0|-1.56|3.0|||Mixed Models Analysis|||Week 48, Mental Component Summary: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.00|-1.56|0.5347
70902039|NCT03502616|141292603|SUPERIORITY||LS mean difference|1.29|STANDARD_ERROR_OF_MEAN|0.898||0.1513|TWO_SIDED|95.0|-0.48|3.06|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.06|-0.48|0.1513
70902040|NCT03502616|141292603|SUPERIORITY||LS mean difference|1.56|STANDARD_ERROR_OF_MEAN|1.02||0.1279|TWO_SIDED|95.0|-0.45|3.56|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.56|-0.45|0.1279
70902041|NCT03502616|141292603|SUPERIORITY||LS mean difference|3.83|STANDARD_ERROR_OF_MEAN|1.056||0.0003|TWO_SIDED|95.0|1.75|5.9|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||5.90|1.75|0.0003
70902042|NCT03502616|141292603|SUPERIORITY||LS mean difference|3.32|STANDARD_ERROR_OF_MEAN|1.282||0.0102|TWO_SIDED|95.0|0.79|5.84|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||5.84|0.79|0.0102
70902043|NCT03502616|141292603|SUPERIORITY||LS mean difference|4.73|STANDARD_ERROR_OF_MEAN|1.285||0.0003|TWO_SIDED|95.0|2.2|7.26|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||7.26|2.20|0.0003
70902044|NCT03502616|141292603|SUPERIORITY||LS mean difference|0.19|STANDARD_ERROR_OF_MEAN|1.439||0.895|TWO_SIDED|95.0|-2.64|3.02|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.02|-2.64|0.8950
70902045|NCT03502616|141292603|SUPERIORITY||LS mean difference|-0.98|STANDARD_ERROR_OF_MEAN|1.365||0.4732|TWO_SIDED|95.0|-3.67|1.71|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.71|-3.67|0.4732
70902046|NCT03502616|141292603|SUPERIORITY||LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|1.523||0.6359|TWO_SIDED|95.0|-3.72|2.28|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.28|-3.72|0.6359
70902047|NCT03502616|141292603|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|1.495||0.6894|TWO_SIDED|95.0|-3.54|2.35|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.35|-3.54|0.6894
70902048|NCT03502616|141292604|SUPERIORITY||LS mean difference|1.39|STANDARD_ERROR_OF_MEAN|0.94||0.141|TWO_SIDED|95.0|-0.46|3.24|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.24|-0.46|0.1410
70902049|NCT03502616|141292604|SUPERIORITY||LS mean difference|2.78|STANDARD_ERROR_OF_MEAN|1.102||0.0122|TWO_SIDED|95.0|0.61|4.95|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.95|0.61|0.0122
70902050|NCT03502616|141292604|SUPERIORITY||LS mean difference|3.32|STANDARD_ERROR_OF_MEAN|1.252||0.0085|TWO_SIDED|95.0|0.86|5.79|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||5.79|0.86|0.0085
70902051|NCT03502616|141292604|SUPERIORITY||LS mean difference|3.36|STANDARD_ERROR_OF_MEAN|1.416||0.0184|TWO_SIDED|95.0|0.57|6.15|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.15|0.57|0.0184
70902052|NCT03502616|141292604|SUPERIORITY||LS mean difference|4.19|STANDARD_ERROR_OF_MEAN|1.38||0.0026|TWO_SIDED|95.0|1.47|6.91|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.91|1.47|0.0026
70902053|NCT03502616|141292604|SUPERIORITY||LS mean difference|3.4|STANDARD_ERROR_OF_MEAN|1.495||0.0236|TWO_SIDED|95.0|0.46|6.35|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.35|0.46|0.0236
70902054|NCT03502616|141292604|SUPERIORITY||LS mean difference|3.66|STANDARD_ERROR_OF_MEAN|1.541||0.0182|TWO_SIDED|95.0|0.63|6.7|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.70|0.63|0.0182
70902055|NCT03502616|141292604|SUPERIORITY||LS mean difference|3.85|STANDARD_ERROR_OF_MEAN|1.545||0.0133|TWO_SIDED|95.0|0.81|6.9|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.90|0.81|0.0133
70902056|NCT03502616|141292604|SUPERIORITY||LS mean difference|3.49|STANDARD_ERROR_OF_MEAN|1.541||0.0245|TWO_SIDED|95.0|0.45|6.52|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.52|0.45|0.0245
70902057|NCT03502616|141292605|SUPERIORITY||LS mean difference|0.81|STANDARD_ERROR_OF_MEAN|0.257||0.0018|TWO_SIDED|95.0|0.3|1.32|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.32|0.30|0.0018
70902058|NCT03502616|141292605|SUPERIORITY||LS mean difference|1.06|STANDARD_ERROR_OF_MEAN|0.301||0.0005|TWO_SIDED|95.0|0.47|1.65|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.65|0.47|0.0005
70902059|NCT03502616|141292605|SUPERIORITY||LS mean difference|1.19|STANDARD_ERROR_OF_MEAN|0.305||0.0001|TWO_SIDED|95.0|0.59|1.79|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.79|0.59|0.0001
70902060|NCT03502616|141292605|SUPERIORITY||LS mean difference|1.63|STANDARD_ERROR_OF_MEAN|0.274|<|0.0001|TWO_SIDED|95.0|1.09|2.17|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.17|1.09|<0.0001
70902061|NCT03502616|141292605|SUPERIORITY||LS mean difference|1.87|STANDARD_ERROR_OF_MEAN|0.344|<|0.0001|TWO_SIDED|95.0|1.2|2.55|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.55|1.20|<0.0001
70902062|NCT03502616|141292605|SUPERIORITY||LS mean difference|0.95|STANDARD_ERROR_OF_MEAN|0.353||0.0075|TWO_SIDED|95.0|0.26|1.65|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.65|0.26|0.0075
70902063|NCT03502616|141292605|SUPERIORITY||LS mean difference|0.58|STANDARD_ERROR_OF_MEAN|0.403||0.1489|TWO_SIDED|95.0|-0.21|1.38|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.38|-0.21|0.1489
70902064|NCT03502616|141292605|SUPERIORITY||LS mean difference|0.78|STANDARD_ERROR_OF_MEAN|0.417||0.0609|TWO_SIDED|95.0|-0.04|1.61|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.61|-0.04|0.0609
70902065|NCT03502616|141292605|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.429||0.4822|TWO_SIDED|95.0|-0.54|1.15|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.15|-0.54|0.4822
70902066|NCT03502616|141292606|SUPERIORITY||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.131||0.0047|TWO_SIDED|95.0|0.12|0.63|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.63|0.12|0.0047
70902067|NCT03502616|141292606|SUPERIORITY||LS mean difference|0.52|STANDARD_ERROR_OF_MEAN|0.131||0.0001|TWO_SIDED|95.0|0.26|0.77|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.77|0.26|0.0001
70902068|NCT03502616|141292606|SUPERIORITY||LS mean difference|0.49|STANDARD_ERROR_OF_MEAN|0.148||0.0012|TWO_SIDED|95.0|0.19|0.78|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.78|0.19|0.0012
70902069|NCT03502616|141292606|SUPERIORITY||LS mean difference|0.48|STANDARD_ERROR_OF_MEAN|0.142||0.0008|TWO_SIDED|95.0|0.2|0.76|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.76|0.20|0.0008
70902070|NCT03502616|141292606|SUPERIORITY||LS mean difference|0.53|STANDARD_ERROR_OF_MEAN|0.147||0.0004|TWO_SIDED|95.0|0.24|0.81|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.81|0.24|0.0004
70902071|NCT03502616|141292606|SUPERIORITY||LS mean difference|0.32|STANDARD_ERROR_OF_MEAN|0.188||0.0918|TWO_SIDED|95.0|-0.05|0.69|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.69|-0.05|0.0918
70902072|NCT03502616|141292606|SUPERIORITY||LS mean difference|0.25|STANDARD_ERROR_OF_MEAN|0.179||0.16|TWO_SIDED|95.0|-0.1|0.61|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.61|-0.10|0.1600
70902073|NCT03502616|141292606|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.195||0.6776|TWO_SIDED|95.0|-0.3|0.47|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.47|-0.30|0.6776
70902074|NCT03502616|141292606|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.18||0.5646|TWO_SIDED|95.0|-0.25|0.46|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.46|-0.25|0.5646
70902075|NCT03502616|141292607|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.161||0.7291|TWO_SIDED|95.0|-0.26|0.37|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.37|-0.26|0.7291
70902076|NCT03502616|141292607|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.184||0.0257|TWO_SIDED|95.0|-0.78|-0.05|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.05|-0.78|0.0257
70902077|NCT03502616|141292607|SUPERIORITY||LS mean difference|-0.86|STANDARD_ERROR_OF_MEAN|0.227||0.0002|TWO_SIDED|95.0|-1.31|-0.42|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.42|-1.31|0.0002
70902078|NCT03502616|141292607|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.216||0.0041|TWO_SIDED|95.0|-1.05|-0.2|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.20|-1.05|0.0041
70902079|NCT03502616|141292607|SUPERIORITY||LS mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.215||0.0062|TWO_SIDED|95.0|-1.02|-0.17|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.17|-1.02|0.0062
70902080|NCT03502616|141292607|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.255||0.014|TWO_SIDED|95.0|-1.13|-0.13|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.13|-1.13|0.0140
70902081|NCT03502616|141292607|SUPERIORITY||LS mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.225||0.0035|TWO_SIDED|95.0|-1.11|-0.22|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.22|-1.11|0.0035
70902082|NCT03502616|141292607|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.253||0.0645|TWO_SIDED|95.0|-0.97|0.03|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.03|-0.97|0.0645
70902083|NCT03502616|141292607|SUPERIORITY||LS mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.255||0.0341|TWO_SIDED|95.0|-1.05|-0.04|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.04|-1.05|0.0341
70902084|NCT03502616|141292608|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.056||0.0001|TWO_SIDED|95.0|-0.33|-0.11|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.11|-0.33|0.0001
70902085|NCT03502616|141292608|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001|TWO_SIDED|95.0|-0.47|-0.2|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.20|-0.47|<0.0001
70902086|NCT03502616|141292608|SUPERIORITY||LS mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|-0.61|-0.31|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.31|-0.61|<0.0001
70902087|NCT03502616|141292608|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|-0.62|-0.32|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.32|-0.62|<0.0001
70902088|NCT03502616|141292608|SUPERIORITY||LS mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.077|<|0.0001|TWO_SIDED|95.0|-0.67|-0.37|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.37|-0.67|<0.0001
70902089|NCT03502616|141292608|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.086||0.0008|TWO_SIDED|95.0|-0.46|-0.12|||LS mean difference|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.12|-0.46|0.0008
70902090|NCT03502616|141292608|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.086||0.0116|TWO_SIDED|95.0|-0.39|-0.05|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.05|-0.39|0.0116
70902091|NCT03502616|141292608|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.093||0.0416|TWO_SIDED|95.0|-0.37|-0.01|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.01|-0.37|0.0416
70902092|NCT03502616|141292608|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.092||0.0915|TWO_SIDED|95.0|-0.34|0.03|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.03|-0.34|0.0915
70902093|NCT03502616|141292609|SUPERIORITY||LS mean difference|2.85|STANDARD_ERROR_OF_MEAN|0.706|<|0.0001|TWO_SIDED|95.0|1.46|4.24|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.24|1.46|<0.0001
70902094|NCT03502616|141292609|SUPERIORITY||LS mean difference|3.61|STANDARD_ERROR_OF_MEAN|0.761|<|0.0001|TWO_SIDED|95.0|2.11|5.1|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||5.10|2.11|<0.0001
70902095|NCT03502616|141292609|SUPERIORITY||LS mean difference|5.42|STANDARD_ERROR_OF_MEAN|0.902|<|0.0001|TWO_SIDED|95.0|3.65|7.2|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||7.20|3.65|<0.0001
70902096|NCT03502616|141292609|SUPERIORITY||LS mean difference|5.01|STANDARD_ERROR_OF_MEAN|0.943|<|0.0001|TWO_SIDED|95.0|3.15|6.86|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.86|3.15|<0.0001
70902097|NCT03502616|141292609|SUPERIORITY||LS mean difference|3.43|STANDARD_ERROR_OF_MEAN|1.012||0.0008|TWO_SIDED|95.0|1.44|5.42|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||5.42|1.44|0.0008
70902098|NCT03502616|141292609|SUPERIORITY||LS mean difference|1.58|STANDARD_ERROR_OF_MEAN|1.064||0.139|TWO_SIDED|95.0|-0.52|3.68|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.68|-0.52|0.1390
70902099|NCT03502616|141292609|SUPERIORITY||LS mean difference|0.66|STANDARD_ERROR_OF_MEAN|1.024||0.5217|TWO_SIDED|95.0|-1.36|2.67|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.67|-1.36|0.5217
70902100|NCT03502616|141292609|SUPERIORITY||LS mean difference|1.51|STANDARD_ERROR_OF_MEAN|1.027||0.1415|TWO_SIDED|95.0|-0.51|3.54|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.54|-0.51|0.1415
70902101|NCT03502616|141292609|SUPERIORITY||LS mean difference|2.19|STANDARD_ERROR_OF_MEAN|1.128||0.0533|TWO_SIDED|95.0|-0.03|4.41|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.41|-0.03|0.0533
70902102|NCT03502616|141292610|SUPERIORITY||LS mean difference|1.25|STANDARD_ERROR_OF_MEAN|0.352||0.0005|TWO_SIDED|95.0|0.55|1.94|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.94|0.55|0.0005
70902103|NCT03502616|141292610|SUPERIORITY||LS mean difference|1.7|STANDARD_ERROR_OF_MEAN|0.381|<|0.0001|TWO_SIDED|95.0|0.95|2.45|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.45|0.95|<0.0001
70902104|NCT03502616|141292610|SUPERIORITY||LS mean difference|2.19|STANDARD_ERROR_OF_MEAN|0.423|<|0.0001|TWO_SIDED|95.0|1.35|3.02|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.02|1.35|<0.0001
70902105|NCT03502616|141292610|SUPERIORITY||LS mean difference|1.98|STANDARD_ERROR_OF_MEAN|0.439|<|0.0001|TWO_SIDED|95.0|1.11|2.84|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.84|1.11|<0.0001
70902106|NCT03502616|141292610|SUPERIORITY||LS mean difference|1.56|STANDARD_ERROR_OF_MEAN|0.454||0.0007|TWO_SIDED|95.0|0.67|2.45|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.45|0.67|0.0007
70902107|NCT03502616|141292610|SUPERIORITY||LS mean difference|0.62|STANDARD_ERROR_OF_MEAN|0.485||0.2018|TWO_SIDED|95.0|-0.33|1.58|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.58|-0.33|0.2018
70902108|NCT03502616|141292610|SUPERIORITY||LS mean difference|0.22|STANDARD_ERROR_OF_MEAN|0.465||0.6432|TWO_SIDED|95.0|-0.7|1.13|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.13|-0.70|0.6432
70902109|NCT03502616|141292610|SUPERIORITY||LS mean difference|0.39|STANDARD_ERROR_OF_MEAN|0.47||0.4092|TWO_SIDED|95.0|-0.54|1.31|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.31|-0.54|0.4092
70902110|NCT03502616|141292610|SUPERIORITY||LS mean difference|0.82|STANDARD_ERROR_OF_MEAN|0.506||0.107|TWO_SIDED|95.0|-0.18|1.81|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.81|-0.18|0.1070
70902111|NCT03502616|141292611|SUPERIORITY||LS mean difference|1.62|STANDARD_ERROR_OF_MEAN|0.428||0.0002|TWO_SIDED|95.0|0.78|2.46|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.46|0.78|0.0002
70902112|NCT03502616|141292611|SUPERIORITY||LS mean difference|1.92|STANDARD_ERROR_OF_MEAN|0.466|<|0.0001|TWO_SIDED|95.0|1.0|2.84|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.84|1.00|<0.0001
70902113|NCT03502616|141292611|SUPERIORITY||LS mean difference|3.26|STANDARD_ERROR_OF_MEAN|0.549|<|0.0001|TWO_SIDED|95.0|2.18|4.34|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.34|2.18|<0.0001
70902114|NCT03502616|141292611|SUPERIORITY||LS mean difference|3.04|STANDARD_ERROR_OF_MEAN|0.564|<|0.0001|TWO_SIDED|95.0|1.93|4.15|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.15|1.93|<0.0001
70902115|NCT03502616|141292611|SUPERIORITY||LS mean difference|1.87|STANDARD_ERROR_OF_MEAN|0.621||0.0028|TWO_SIDED|95.0|0.65|3.09|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.09|0.65|0.0028
70902116|NCT03502616|141292611|SUPERIORITY||LS mean difference|0.97|STANDARD_ERROR_OF_MEAN|0.638||0.1289|TWO_SIDED|95.0|-0.28|2.23|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.23|-0.28|0.1289
70902117|NCT03502616|141292611|SUPERIORITY||LS mean difference|0.45|STANDARD_ERROR_OF_MEAN|0.616||0.4698|TWO_SIDED|95.0|-0.77|1.66|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.66|-0.77|0.4698
70902118|NCT03502616|141292611|SUPERIORITY||LS mean difference|1.13|STANDARD_ERROR_OF_MEAN|0.603||0.0616|TWO_SIDED|95.0|-0.06|2.32|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.32|-0.06|0.0616
70902119|NCT03502616|141292611|SUPERIORITY||LS mean difference|1.37|STANDARD_ERROR_OF_MEAN|0.681||0.0455|TWO_SIDED|95.0|0.03|2.71|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.71|0.03|0.0455
70902120|NCT03502616|141292612|SUPERIORITY||LS mean difference|-0.88|STANDARD_ERROR_OF_MEAN|0.185|<|0.0001|TWO_SIDED|95.0|-1.25|-0.52|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.52|-1.25|<0.0001
70902121|NCT03502616|141292612|SUPERIORITY||LS mean difference|-1.22|STANDARD_ERROR_OF_MEAN|0.215|<|0.0001|TWO_SIDED|95.0|-1.65|-0.8|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.80|-1.65|<0.0001
70902122|NCT03502616|141292612|SUPERIORITY||LS mean difference|-1.71|STANDARD_ERROR_OF_MEAN|0.232|<|0.0001|TWO_SIDED|95.0|-2.17|-1.26|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.26|-2.17|<0.0001
70902123|NCT03502616|141292612|SUPERIORITY||LS mean difference|-1.72|STANDARD_ERROR_OF_MEAN|0.247|<|0.0001|TWO_SIDED|95.0|-2.2|-1.23|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.23|-2.20|<0.0001
70902124|NCT03502616|141292612|SUPERIORITY||LS mean difference|-1.56|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.07|-1.05|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.05|-2.07|<0.0001
70902125|NCT03502616|141292612|SUPERIORITY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.281||0.0483|TWO_SIDED|95.0|-1.11|0.0|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.00|-1.11|0.0483
70902126|NCT03502616|141292612|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.286||0.0357|TWO_SIDED|95.0|-1.17|-0.04|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.04|-1.17|0.0357
70902127|NCT03502616|141292612|SUPERIORITY||LS mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.278||0.0508|TWO_SIDED|95.0|-1.09|0.0|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.00|-1.09|0.0508
70902128|NCT03502616|141292612|SUPERIORITY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.282||0.0614|TWO_SIDED|95.0|-1.08|0.03|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.03|-1.08|0.0614
70902129|NCT03502616|141292613|SUPERIORITY||LS mean difference|-0.89|STANDARD_ERROR_OF_MEAN|0.186|<|0.0001|TWO_SIDED|95.0|-1.26|-0.53|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.53|-1.26|<0.0001
70902130|NCT03502616|141292613|SUPERIORITY||LS mean difference|-1.34|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.75|-0.92|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.92|-1.75|<0.0001
70902131|NCT03502616|141292613|SUPERIORITY||LS mean difference|-1.98|STANDARD_ERROR_OF_MEAN|0.221|<|0.0001|TWO_SIDED|95.0|-2.41|-1.54|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.54|-2.41|<0.0001
70902132|NCT03502616|141292613|SUPERIORITY||LS mean difference|-1.89|STANDARD_ERROR_OF_MEAN|0.245|<|0.0001|TWO_SIDED|95.0|-2.37|-1.4|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.40|-2.37|<0.0001
70902133|NCT03502616|141292613|SUPERIORITY||LS mean difference|-1.62|STANDARD_ERROR_OF_MEAN|0.243|<|0.0001|TWO_SIDED|95.0|-2.1|-1.14|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.14|-2.10|<0.0001
70902134|NCT03502616|141292613|SUPERIORITY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.261||0.0492|TWO_SIDED|95.0|-1.03|0.0|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.00|-1.03|0.0492
70902135|NCT03502616|141292613|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.266||0.2614|TWO_SIDED|95.0|-0.82|0.22|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.22|-0.82|0.2614
70902136|NCT03502616|141292613|SUPERIORITY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.272||0.0722|TWO_SIDED|95.0|-1.03|0.04|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.04|-1.03|0.0722
70902137|NCT03502616|141292613|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.275||0.0121|TWO_SIDED|95.0|-1.24|-0.15|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.15|-1.24|0.0121
70902138|NCT03502616|141292614|SUPERIORITY||LS mean difference|-0.92|STANDARD_ERROR_OF_MEAN|0.207|<|0.0001|TWO_SIDED|95.0|-1.33|-0.51|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.51|-1.33|<0.0001
70902139|NCT03502616|141292614|SUPERIORITY||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.216|<|0.0001|TWO_SIDED|95.0|-2.02|-1.17|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.17|-2.02|<0.0001
70902140|NCT03502616|141292614|SUPERIORITY||LS mean difference|-2.02|STANDARD_ERROR_OF_MEAN|0.244|<|0.0001|TWO_SIDED|95.0|-2.5|-1.54|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.54|-2.50|<0.0001
70902141|NCT03502616|141292614|SUPERIORITY||LS mean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.254|<|0.0001|TWO_SIDED|95.0|-2.5|-1.5|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.50|-2.50|<0.0001
70902142|NCT03502616|141292614|SUPERIORITY||LS mean difference|-1.84|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.35|-1.32|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.32|-2.35|<0.0001
70902143|NCT03502616|141292614|SUPERIORITY||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.274||0.0785|TWO_SIDED|95.0|-1.02|0.06|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.06|-1.02|0.0785
70902144|NCT03502616|141292614|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.275||0.3047|TWO_SIDED|95.0|-0.82|0.26|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.26|-0.82|0.3047
70902145|NCT03502616|141292614|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.283||0.1009|TWO_SIDED|95.0|-1.02|0.09|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.09|-1.02|0.1009
70902146|NCT03502616|141292614|SUPERIORITY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.287||0.0764|TWO_SIDED|95.0|-1.08|0.05|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.05|-1.08|0.0764
70902147|NCT03502616|141292615|SUPERIORITY||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.159||0.0089|TWO_SIDED|95.0|-0.73|-0.11|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.11|-0.73|0.0089
70902148|NCT03502616|141292615|SUPERIORITY||LS mean difference|-0.77|STANDARD_ERROR_OF_MEAN|0.179|<|0.0001|TWO_SIDED|95.0|-1.12|-0.42|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.42|-1.12|<0.0001
70902149|NCT03502616|141292615|SUPERIORITY||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.202|<|0.0001|TWO_SIDED|95.0|-1.5|-0.7|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.70|-1.50|<0.0001
70902150|NCT03502616|141292615|SUPERIORITY||LS mean difference|-1.29|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.71|-0.88|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.88|-1.71|<0.0001
70902151|NCT03502616|141292615|SUPERIORITY||LS mean difference|-1.23|STANDARD_ERROR_OF_MEAN|0.217|<|0.0001|TWO_SIDED|95.0|-1.66|-0.8|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.80|-1.66|<0.0001
70902152|NCT03502616|141292615|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.242||0.1686|TWO_SIDED|95.0|-0.81|0.14|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.14|-0.81|0.1686
70902153|NCT03502616|141292615|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.238||0.28|TWO_SIDED|95.0|-0.72|0.21|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.21|-0.72|0.2800
70902154|NCT03502616|141292615|SUPERIORITY||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.243||0.1135|TWO_SIDED|95.0|-0.86|0.09|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.09|-0.86|0.1135
70902155|NCT03502616|141292615|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.247||0.2496|TWO_SIDED|95.0|-0.77|0.2|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.20|-0.77|0.2496
70902156|NCT03502616|141292616|SUPERIORITY||LS mean difference|-0.84|STANDARD_ERROR_OF_MEAN|0.191|<|0.0001|TWO_SIDED|95.0|-1.22|-0.47|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.47|-1.22|<0.0001
70902157|NCT03502616|141292616|SUPERIORITY||LS mean difference|-1.48|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.89|-1.07|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.07|-1.89|<0.0001
70902158|NCT03502616|141292616|SUPERIORITY||LS mean difference|-1.61|STANDARD_ERROR_OF_MEAN|0.228|<|0.0001|TWO_SIDED|95.0|-2.06|-1.16|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.16|-2.06|<0.0001
70902159|NCT03502616|141292616|SUPERIORITY||LS mean difference|-1.87|STANDARD_ERROR_OF_MEAN|0.237|<|0.0001|TWO_SIDED|95.0|-2.34|-1.4|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.40|-2.34|<0.0001
70902160|NCT03502616|141292616|SUPERIORITY||LS mean difference|-1.72|STANDARD_ERROR_OF_MEAN|0.236|<|0.0001|TWO_SIDED|95.0|-2.18|-1.25|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.25|-2.18|<0.0001
70902161|NCT03502616|141292616|SUPERIORITY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.245||0.0385|TWO_SIDED|95.0|-0.99|-0.03|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.03|-0.99|0.0385
70902162|NCT03502616|141292616|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.252||0.0463|TWO_SIDED|95.0|-1.0|-0.01|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.01|-1.00|0.0463
70902163|NCT03502616|141292616|SUPERIORITY||LS mean difference|-0.65|STANDARD_ERROR_OF_MEAN|0.257||0.0126|TWO_SIDED|95.0|-1.15|-0.14|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.14|-1.15|0.0126
70902164|NCT03502616|141292616|SUPERIORITY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.268||0.0372|TWO_SIDED|95.0|-1.09|-0.03|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.03|-1.09|0.0372
70902165|NCT03502616|141292617|SUPERIORITY||Difference in percentage|13.6|STANDARD_ERROR_OF_MEAN|3.53||0.0001|TWO_SIDED|95.0|6.68|20.52|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||20.52|6.68|0.0001
70902166|NCT03502616|141292617|SUPERIORITY||Difference in percentage|28.79|STANDARD_ERROR_OF_MEAN|4.6|<|0.0001|TWO_SIDED|95.0|19.78|37.8|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||37.80|19.78|<0.0001
70902167|NCT03502616|141292617|SUPERIORITY||Difference in percentage|33.31|STANDARD_ERROR_OF_MEAN|4.83|<|0.0001|TWO_SIDED|95.0|23.84|42.78|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||42.78|23.84|<0.0001
70902168|NCT03502616|141292617|SUPERIORITY||Difference in percentage|36.37|STANDARD_ERROR_OF_MEAN|4.95|<|0.0001|TWO_SIDED|95.0|26.67|46.07|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||46.07|26.67|<0.0001
70902169|NCT03502616|141292617|SUPERIORITY||Difference in percentage|36.34|STANDARD_ERROR_OF_MEAN|4.74|<|0.0001|TWO_SIDED|95.0|27.05|45.63|||Cochran-Mantel-Haenszel|||Week 16: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||45.63|27.05|<0.0001
70902170|NCT03502616|141292617|SUPERIORITY||Difference in percentage|5.6|STANDARD_ERROR_OF_MEAN|5.99||0.3498|TWO_SIDED|95.0|-6.14|17.35|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||17.35|-6.14|0.3498
70902171|NCT03502616|141292617|SUPERIORITY||Difference in percentage|-2.4|STANDARD_ERROR_OF_MEAN|5.89||0.6835|TWO_SIDED|95.0|-13.96|9.15|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||9.15|-13.96|0.6835
70902172|NCT03502616|141292617|SUPERIORITY||Difference in percentage|-1.75|STANDARD_ERROR_OF_MEAN|5.98||0.7704|TWO_SIDED|95.0|-13.47|9.98|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||9.98|-13.47|0.7704
70902173|NCT03502616|141292617|SUPERIORITY||Difference in percentage|-1.13|STANDARD_ERROR_OF_MEAN|5.95||0.8492|TWO_SIDED|95.0|-12.8|10.53|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||10.53|-12.80|0.8492
70902174|NCT03502616|141292618|SUPERIORITY||Difference in percentage|2.24|STANDARD_ERROR_OF_MEAN|1.63||0.1692|TWO_SIDED|95.0|-0.95|5.43|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||5.43|-0.95|0.1692
70902175|NCT03502616|141292618|SUPERIORITY||Difference in percentage|4.46|STANDARD_ERROR_OF_MEAN|2.04||0.0289|TWO_SIDED|95.0|0.46|8.46|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||8.46|0.46|0.0289
70902176|NCT03502616|141292618|SUPERIORITY||Difference in percentage|6.02|STANDARD_ERROR_OF_MEAN|2.59||0.0199|TWO_SIDED|95.0|0.95|11.09|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||11.09|0.95|0.0199
70902177|NCT03502616|141292618|SUPERIORITY||Difference in percentage|12.03|STANDARD_ERROR_OF_MEAN|3.46||0.0005|TWO_SIDED|95.0|5.26|18.81|||Difference in percentage|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||18.81|5.26|0.0005
70902178|NCT03502616|141292618|SUPERIORITY||Difference in percentage|12.05|STANDARD_ERROR_OF_MEAN|3.45||0.0005|TWO_SIDED|95.0|5.29|18.8|||Cochran-Mantel-Haenszel|||Week 16: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||18.80|5.29|0.0005
70902179|NCT03502616|141292618|SUPERIORITY||Difference in percentage|10.03|STANDARD_ERROR_OF_MEAN|4.49||0.0253|TWO_SIDED|95.0|1.24|18.83|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||18.83|1.24|0.0253
70902180|NCT03502616|141292618|SUPERIORITY||Difference in percentage|7.93|STANDARD_ERROR_OF_MEAN|4.75||0.095|TWO_SIDED|95.0|-1.38|17.24|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||17.24|-1.38|0.0950
70902181|NCT03502616|141292618|SUPERIORITY||Difference in percentage|7.21|STANDARD_ERROR_OF_MEAN|4.86||0.1377|TWO_SIDED|95.0|-2.31|16.73|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||16.73|-2.31|0.1377
70902182|NCT03502616|141292618|SUPERIORITY||Difference in percentage|5.68|STANDARD_ERROR_OF_MEAN|4.91||0.2472|TWO_SIDED|95.0|-3.94|15.3|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||15.30|-3.94|0.2472
70902183|NCT03502616|141292619|SUPERIORITY||LS mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.163|<|0.0001|TWO_SIDED|95.0|-1.05|-0.41|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.41|-1.05|<0.0001
70902184|NCT03502616|141292619|SUPERIORITY||LS mean difference|-1.28|STANDARD_ERROR_OF_MEAN|0.187|<|0.0001|TWO_SIDED|95.0|-1.65|-0.91|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.91|-1.65|<0.0001
70902185|NCT03502616|141292619|SUPERIORITY||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.92|-1.09|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.09|-1.92|<0.0001
70902186|NCT03502616|141292619|SUPERIORITY||LS mean difference|-1.68|STANDARD_ERROR_OF_MEAN|0.221|<|0.0001|TWO_SIDED|95.0|-2.11|-1.24|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.24|-2.11|<0.0001
70902187|NCT03502616|141292619|SUPERIORITY||LS mean difference|-1.44|STANDARD_ERROR_OF_MEAN|0.223|<|0.0001|TWO_SIDED|95.0|-1.88|-1.0|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.00|-1.88|<0.0001
70902188|NCT03502616|141292619|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.235||0.088|TWO_SIDED|95.0|-0.86|0.06|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.06|-0.86|0.0880
70902189|NCT03502616|141292619|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.241||0.0921|TWO_SIDED|95.0|-0.88|0.07|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.07|-0.88|0.0921
70902190|NCT03502616|141292619|SUPERIORITY||LS mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.243||0.0597|TWO_SIDED|95.0|-0.94|0.02|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.02|-0.94|0.0597
70902191|NCT03502616|141292619|SUPERIORITY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.25||0.0492|TWO_SIDED|95.0|-0.99|0.0|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.00|-0.99|0.0492
70902192|NCT03502616|141292620|SUPERIORITY||Difference in percentage|8.31|STANDARD_ERROR_OF_MEAN|3.29||0.0116|TWO_SIDED|95.0|1.86|14.77|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||14.77|1.86|0.0116
70902193|NCT03502616|141292620|SUPERIORITY||Difference in percentage|22.74|STANDARD_ERROR_OF_MEAN|4.46|<|0.0001|TWO_SIDED|95.0|13.99|31.49|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||31.49|13.99|<0.0001
70902194|NCT03502616|141292620|SUPERIORITY||Difference in percentage|28.87|STANDARD_ERROR_OF_MEAN|4.99|<|0.0001|TWO_SIDED|95.0|19.09|38.66|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||38.66|19.09|<0.0001
70902195|NCT03502616|141292620|SUPERIORITY||Difference in percentage|31.93|STANDARD_ERROR_OF_MEAN|4.92|<|0.0001|TWO_SIDED|95.0|22.28|41.58|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||41.58|22.28|<0.0001
70902196|NCT03502616|141292620|SUPERIORITY||Difference in percentage|25.28|STANDARD_ERROR_OF_MEAN|5.34|<|0.0001|TWO_SIDED|95.0|14.82|35.75|||Cochran-Mantel-Haenszel|||Week 16: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||35.75|14.82|<0.0001
70902197|NCT03502616|141292620|SUPERIORITY||Difference in percentage|10.71|STANDARD_ERROR_OF_MEAN|5.88||0.0683|TWO_SIDED|95.0|-0.8|22.23|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||22.23|-0.80|0.0683
70902198|NCT03502616|141292620|SUPERIORITY||Difference in percentage|10.05|STANDARD_ERROR_OF_MEAN|5.94||0.0906|TWO_SIDED|95.0|-1.59|21.7|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||21.70|-1.59|0.0906
70902199|NCT03502616|141292620|SUPERIORITY||Difference in percentage|13.03|STANDARD_ERROR_OF_MEAN|5.94||0.0282|TWO_SIDED|95.0|1.39|24.66|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||24.66|1.39|0.0282
70902200|NCT03502616|141292620|SUPERIORITY||Difference in percentage|10.77|STANDARD_ERROR_OF_MEAN|5.98||0.0719|TWO_SIDED|95.0|-0.96|22.49|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||22.49|-0.96|0.0719
70902201|NCT03502616|141292621|SUPERIORITY||Difference in percentage|32.79|STANDARD_ERROR_OF_MEAN|4.75|<|0.0001|TWO_SIDED|95.0|23.48|42.11|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||42.11|23.48|<0.0001
70902202|NCT03502616|141292621|SUPERIORITY||Difference in percentage|40.53|STANDARD_ERROR_OF_MEAN|5.19|<|0.0001|TWO_SIDED|95.0|30.37|50.7|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||50.70|30.37|<0.0001
70902203|NCT03502616|141292621|SUPERIORITY||Difference in percentage|45.22|STANDARD_ERROR_OF_MEAN|5.2|<|0.0001|TWO_SIDED|95.0|35.03|55.41|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||55.41|35.03|<0.0001
70902204|NCT03502616|141292621|SUPERIORITY||Difference in percentage|45.23|STANDARD_ERROR_OF_MEAN|5.23|<|0.0001|TWO_SIDED|95.0|34.97|55.49|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||55.49|34.97|<0.0001
70902205|NCT03502616|141292621|SUPERIORITY||Difference in percentage|42.3|STANDARD_ERROR_OF_MEAN|5.4|<|0.0001|TWO_SIDED|95.0|31.73|52.88|||Cochran-Mantel-Haenszel|||Week 16: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||52.88|31.73|<0.0001
70902206|NCT03502616|141292621|SUPERIORITY||Difference in percentage|4.96|STANDARD_ERROR_OF_MEAN|5.85||0.3967|TWO_SIDED|95.0|-6.51|16.42|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||16.42|-6.51|0.3967
70902207|NCT03502616|141292621|SUPERIORITY||Difference in percentage|4.34|STANDARD_ERROR_OF_MEAN|5.67||0.4442|TWO_SIDED|95.0|-6.78|15.46|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||15.46|-6.78|0.4442
70902208|NCT03502616|141292621|SUPERIORITY||Difference in percentage|6.38|STANDARD_ERROR_OF_MEAN|5.92||0.281|TWO_SIDED|95.0|-5.22|17.97|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||17.97|-5.22|0.2810
70902209|NCT03502616|141292621|SUPERIORITY||Difference in percentage|5.54|STANDARD_ERROR_OF_MEAN|5.95||0.3514|TWO_SIDED|95.0|-6.12|17.2|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||17.20|-6.12|0.3514
70902210|NCT03502616|141292622|SUPERIORITY||Difference in percentage|8.84|STANDARD_ERROR_OF_MEAN|2.74||0.0013|TWO_SIDED|95.0|3.46|14.21|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||14.21|3.46|0.0013
70902211|NCT03502616|141292622|SUPERIORITY||Difference in percentage|16.25|STANDARD_ERROR_OF_MEAN|3.63|<|0.0001|TWO_SIDED|95.0|9.13|23.36|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||23.36|9.13|<0.0001
70902212|NCT03502616|141292622|SUPERIORITY||Difference in percentage|20.31|STANDARD_ERROR_OF_MEAN|4.03|<|0.0001|TWO_SIDED|95.0|12.41|28.2|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||28.20|12.41|<0.0001
70902213|NCT03502616|141292622|SUPERIORITY||Difference in percentage|22.77|STANDARD_ERROR_OF_MEAN|4.24|<|0.0001|TWO_SIDED|95.0|14.46|31.08|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||31.08|14.46|<0.0001
70902214|NCT03502616|141292622|SUPERIORITY||Difference in percentage|25.28|STANDARD_ERROR_OF_MEAN|4.5|<|0.0001|TWO_SIDED|95.0|16.47|34.1|||Cochran-Mantel-Haenszel|||Week 16: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||34.10|16.47|<0.0001
70902215|NCT03502616|141292622|SUPERIORITY||Difference in percentage|9.41|STANDARD_ERROR_OF_MEAN|5.62||0.0941|TWO_SIDED|95.0|-1.61|20.43|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||20.43|-1.61|0.0941
70902216|NCT03502616|141292622|SUPERIORITY||Difference in percentage|2.52|STANDARD_ERROR_OF_MEAN|5.96||0.6727|TWO_SIDED|95.0|-9.17|14.21|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||14.21|-9.17|0.6727
70902217|NCT03502616|141292622|SUPERIORITY||Difference in percentage|7.29|STANDARD_ERROR_OF_MEAN|5.96||0.2213|TWO_SIDED|95.0|-4.39|18.98|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||18.98|-4.39|0.2213
70902218|NCT03502616|141292622|SUPERIORITY||Difference in percentage|4.7|STANDARD_ERROR_OF_MEAN|5.76||0.4137|TWO_SIDED|95.0|-6.58|15.98|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||15.98|-6.58|0.4137
70902219|NCT03502616|141292623|SUPERIORITY||Difference in percentage|0.75|STANDARD_ERROR_OF_MEAN|1.27||0.5518|TWO_SIDED|95.0|-1.73|3.24|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||3.24|-1.73|0.5518
70902220|NCT03502616|141292623|SUPERIORITY||Difference in percentage|3.72|STANDARD_ERROR_OF_MEAN|1.92||0.0524|TWO_SIDED|95.0|-0.04|7.47|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||7.47|-0.04|0.0524
70902221|NCT03502616|141292623|SUPERIORITY||Difference in percentage|5.25|STANDARD_ERROR_OF_MEAN|2.29||0.0216|TWO_SIDED|95.0|0.77|9.73|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||9.73|0.77|0.0216
70902222|NCT03502616|141292623|SUPERIORITY||Difference in percentage|10.48|STANDARD_ERROR_OF_MEAN|2.9||0.0003|TWO_SIDED|95.0|4.8|16.17|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||16.17|4.80|0.0003
70902223|NCT03502616|141292623|SUPERIORITY||Difference in percentage|6.69|STANDARD_ERROR_OF_MEAN|2.37||0.0047|TWO_SIDED|95.0|2.05|11.33|||Cochran-Mantel-Haenszel|||Week 16: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||11.33|2.05|0.0047
70902224|NCT03502616|141292623|SUPERIORITY||Difference in percentage|1.07|STANDARD_ERROR_OF_MEAN|3.98||0.7883|TWO_SIDED|95.0|-6.74|8.88|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||8.88|-6.74|0.7883
70902225|NCT03502616|141292623|SUPERIORITY||Difference in percentage|4.85|STANDARD_ERROR_OF_MEAN|4.4||0.2708|TWO_SIDED|95.0|-3.78|13.48|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||13.48|-3.78|0.2708
70902226|NCT03502616|141292623|SUPERIORITY||Difference in percentage|0.44|STANDARD_ERROR_OF_MEAN|4.55||0.9226|TWO_SIDED|95.0|-8.48|9.36|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||9.36|-8.48|0.9226
70902227|NCT03502616|141292623|SUPERIORITY||Difference in percentage|1.84|STANDARD_ERROR_OF_MEAN|4.23||0.663|TWO_SIDED|95.0|-6.44|10.13|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||10.13|-6.44|0.6630
70902228|NCT03502616|141292624|SUPERIORITY||LS mean difference|-0.84|STANDARD_ERROR_OF_MEAN|0.319||0.0099|TWO_SIDED|95.0|-1.47|-0.2|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.20|-1.47|0.0099
70902229|NCT03502616|141292624|SUPERIORITY||LS mean difference|-0.74|STANDARD_ERROR_OF_MEAN|0.332||0.0275|TWO_SIDED|95.0|-1.4|-0.08|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.08|-1.40|0.0275
70902230|NCT03502616|141292624|SUPERIORITY||LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.35||0.042|TWO_SIDED|95.0|-1.41|-0.03|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.03|-1.41|0.0420
70902231|NCT03502616|141292624|SUPERIORITY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.349||0.1309|TWO_SIDED|95.0|-1.22|0.16|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.16|-1.22|0.1309
70902232|NCT03502616|141292624|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.305||0.5566|TWO_SIDED|95.0|-0.78|0.42|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.42|-0.78|0.5566
70902233|NCT03502616|141292624|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.248||0.4497|TWO_SIDED|95.0|-0.68|0.3|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.30|-0.68|0.4497
70902234|NCT03502616|141292624|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.227||0.9272|TWO_SIDED|95.0|-0.43|0.47|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.47|-0.43|0.9272
70902235|NCT03502616|141292624|SUPERIORITY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.273||0.2539|TWO_SIDED|95.0|-0.85|0.23|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.23|-0.85|0.2539
70902236|NCT03502616|141292625|SUPERIORITY||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.479||0.4379|TWO_SIDED|95.0|-0.58|1.33|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.33|-0.58|0.4379
70902237|NCT03502616|141292625|SUPERIORITY||LS mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.532||0.534|TWO_SIDED|95.0|-0.73|1.39|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.39|-0.73|0.5340
70902238|NCT03502616|141292625|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.582||0.9148|TWO_SIDED|95.0|-1.1|1.22|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.22|-1.10|0.9148
70902239|NCT03502616|141292625|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.548||0.5409|TWO_SIDED|95.0|-1.43|0.76|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.76|-1.43|0.5409
70902240|NCT03502616|141292625|SUPERIORITY||LS mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.607||0.3555|TWO_SIDED|95.0|-1.78|0.65|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.65|-1.78|0.3555
70902241|NCT03502616|141292625|SUPERIORITY||LS mean difference|0.51|STANDARD_ERROR_OF_MEAN|0.436||0.2485|TWO_SIDED|95.0|-0.36|1.38|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.38|-0.36|0.2485
70902242|NCT03502616|141292625|SUPERIORITY||LS mean difference|0.76|STANDARD_ERROR_OF_MEAN|0.435||0.0866|TWO_SIDED|95.0|-0.11|1.63|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.63|-0.11|0.0866
70902243|NCT03502616|141292625|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.356||0.4101|TWO_SIDED|95.0|-0.42|1.01|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.01|-0.42|0.4101
70902244|NCT03502616|141292625|SUPERIORITY||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.217||0.0237|TWO_SIDED|95.0|0.07|0.94|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.94|0.07|0.0237
70902245|NCT03502616|141292626|SUPERIORITY||LS mean difference|0.31|STANDARD_ERROR_OF_MEAN|0.107||0.0043|TWO_SIDED|95.0|0.1|0.52|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.52|0.10|0.0043
70902246|NCT03502616|141292626|SUPERIORITY||LS mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.121||0.0072|TWO_SIDED|95.0|0.09|0.56|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.56|0.09|0.0072
70902247|NCT03502616|141292626|SUPERIORITY||LS mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.146||0.1101|TWO_SIDED|95.0|-0.05|0.52|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.52|-0.05|0.1101
70902248|NCT03502616|141292626|SUPERIORITY||LS mean difference|0.32|STANDARD_ERROR_OF_MEAN|0.13||0.0147|TWO_SIDED|95.0|0.06|0.58|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.58|0.06|0.0147
70902249|NCT03502616|141292626|SUPERIORITY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.162||0.2032|TWO_SIDED|95.0|-0.11|0.53|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.53|-0.11|0.2032
70902250|NCT03502616|141292626|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.168||0.9345|TWO_SIDED|95.0|-0.34|0.32|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.32|-0.34|0.9345
70902251|NCT03502616|141292626|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.187||0.5968|TWO_SIDED|95.0|-0.47|0.27|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.27|-0.47|0.5968
70902252|NCT03502616|141292626|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.166||0.7047|TWO_SIDED|95.0|-0.26|0.39|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.39|-0.26|0.7047
70902253|NCT03502616|141292626|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.157||0.807|TWO_SIDED|95.0|-0.27|0.35|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.35|-0.27|0.8070
70902254|NCT03502616|141292627|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.055||0.003|TWO_SIDED|95.0|-0.28|-0.06|||ANCOVA|||Week 16, Mobility: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||-0.06|-0.28|0.0030
70902255|NCT03502616|141292627|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.055||0.897|TWO_SIDED|95.0|-0.11|0.1|||ANCOVA|||Week 16, Self-Care: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||0.10|-0.11|0.8970
70902256|NCT03502616|141292627|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.058||0.1437|TWO_SIDED|95.0|-0.2|0.03|||ANCOVA|||Week 16, Usual Activities: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||0.03|-0.20|0.1437
70902257|NCT03502616|141292627|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.046|<|0.0001|TWO_SIDED|95.0|-0.27|-0.09|||ANCOVA|||Week 16, Pain/Discomfort: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||-0.09|-0.27|<0.0001
70902258|NCT03502616|141292627|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.061||0.8445|TWO_SIDED|95.0|-0.13|0.11|||ANCOVA|||Week 16, Anxiety/Depression: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||0.11|-0.13|0.8445
70902259|NCT03502616|141292627|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.064||0.3473|TWO_SIDED|95.0|-0.19|0.07|||Mixed Models Analysis|||Week 48, Mobility: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.07|-0.19|0.3473
70902260|NCT03502616|141292627|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.059||0.9834|TWO_SIDED|95.0|-0.12|0.12|||Mixed Models Analysis|||Week 48, Self-Care: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.12|-0.12|0.9834
70902261|NCT03502616|141292627|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.066||0.7364|TWO_SIDED|95.0|-0.11|0.15|||Mixed Models Analysis|||Week 48, Usual Activities: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.15|-0.11|0.7364
70902262|NCT03502616|141292627|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.059||0.8075|TWO_SIDED|95.0|-0.13|0.1|||Mixed Models Analysis|||Week 48, Pain/Discomfort: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.10|-0.13|0.8075
70902263|NCT03502616|141292627|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.067||0.5461|TWO_SIDED|95.0|-0.09|0.17|||Mixed Models Analysis|||Week 48, Anxiety/Depression: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.17|-0.09|0.5461
70902264|NCT03502616|141292628|SUPERIORITY||LS mean difference|10.11|STANDARD_ERROR_OF_MEAN|2.331|<|0.0001|TWO_SIDED|95.0|5.52|14.7|||ANCOVA|||Week 16: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||14.70|5.52|<0.0001
70902265|NCT03502616|141292628|SUPERIORITY||LS mean difference|2.63|STANDARD_ERROR_OF_MEAN|2.337||0.2608|TWO_SIDED|95.0|-1.97|7.24|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||7.24|-1.97|0.2608
70902266|NCT03502616|141292629|SUPERIORITY||LS mean difference|-4.53|STANDARD_ERROR_OF_MEAN|3.35||0.1784|TWO_SIDED|95.0|-11.15|2.09|||ANCOVA|||Week 16: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||2.09|-11.15|0.1784
70902267|NCT03502616|141292629|SUPERIORITY||LS mean difference|-2.31|STANDARD_ERROR_OF_MEAN|2.54||0.3651|TWO_SIDED|95.0|-7.34|2.72|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.72|-7.34|0.3651
70902268|NCT03502616|141292630|SUPERIORITY||LS mean difference|-12.89|STANDARD_ERROR_OF_MEAN|2.884|<|0.0001|TWO_SIDED|95.0|-18.59|-7.19|||ANCOVA|||Week 16: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||-7.19|-18.59|<0.0001
70902269|NCT03502616|141292630|SUPERIORITY||LS mean difference|-2.36|STANDARD_ERROR_OF_MEAN|3.318||0.4788|TWO_SIDED|95.0|-8.92|4.21|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.21|-8.92|0.4788
70902270|NCT03502616|141292631|SUPERIORITY||LS mean difference|-13.85|STANDARD_ERROR_OF_MEAN|3.202|<|0.0001|TWO_SIDED|95.0|-20.18|-7.52|||ANCOVA|||Week 16: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||-7.52|-20.18|<0.0001
70902271|NCT03502616|141292631|SUPERIORITY||LS mean difference|-4.41|STANDARD_ERROR_OF_MEAN|3.613||0.2244|TWO_SIDED|95.0|-11.56|2.74|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.74|-11.56|0.2244
70902272|NCT03502616|141292632|SUPERIORITY||LS mean difference|-13.4|STANDARD_ERROR_OF_MEAN|2.488|<|0.0001|TWO_SIDED|95.0|-18.3|-8.5|||ANCOVA|||Week 16: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||-8.50|-18.30|<0.0001
70902273|NCT03502616|141292632|SUPERIORITY||LS mean difference|-7.6|STANDARD_ERROR_OF_MEAN|2.905||0.0095|TWO_SIDED|95.0|-13.32|-1.88|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.88|-13.32|0.0095
70902274|NCT00770432|141292646|SUPERIORITY_OR_OTHER|||||||0.0595||95.0|||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel adjusted for study site (the smallest study sites were pooled according to a pre-specified rule).||||||0.0595
70902275|NCT01498822|141292658|NON_INFERIORITY_OR_EQUIVALENCE|The primary analysis of this study aimed to demonstrate that LEV was noninferior to OXC with respect to the treatment failure rate in the Per Protocol Set. The noninferiority margin was 15 %.|Absolut difference|-10.7|||||TWO_SIDED|95.0|-20.2|-1.2|||Wald methodology||"Absolute difference in treatment failure rates of LEV versus OXC is defined as Treatment Failure Rate LEV minus Treatment Failure Rate OXC."|||-1.2|-20.2|
70902276|NCT04203537|141292662|SUPERIORITY|||||||0.0004|||||||ANOVA|||||||0.0004
70902277|NCT04203537|141292663|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
70902278|NCT04203537|141292663|SUPERIORITY|||||||0.0026|||||||ANOVA|||||||0.0026
70902279|NCT03131960|141292684|SUPERIORITY|||||||0.0014|||||||ANCOVA|||||||0.0014
70902280|NCT03131960|141292685|SUPERIORITY|||||||0.0077|||||||ANCOVA|||ANCOVA||||0.0077
70902281|NCT03131960|141292686|SUPERIORITY|||||||0.0098|||||||Regression, Logistic|||||||0.0098
70902282|NCT03131960|141292687|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70902283|NCT01625923|141292689|OTHER|T-test comparing GCSI-DD scores before/after intervention||||||0.06|||||||t-test, 2 sided|||||||.06
70902284|NCT02413463|141292704|SUPERIORITY|Chi-square test||||||0.18||||||This is the calculated p-value for the success rate in the Augmented Group Vs. Faden Group|Chi-squared|||An estimation of sample size was performed considering a study power of 0.8 with an alpha error of 0.05 aiming to detect a difference of 5 Δ in the postoperative angle disparity between the 2 groups, assuming a postoperative standard deviation of 6 Δ. Based on this estimation, a total of 24 eyes were found to be adequate in each group, and considering a 25% dropout during the follow-up, recruitment of 30 study subjects in each group was targeted||||0.18
70902285|NCT02413463|141292705|SUPERIORITY|||||||0.22||||||This is the calculated p-value for the postoperative angle of deviation with spectacles for distance in Augmented recession vs. Faden group (First row)|t-test, 2 sided|||||||0.22
70902286|NCT02413463|141292706|SUPERIORITY|||||||0.02||||||This is the calculated p-value for the postoperative angle of deviation without spectacles for near in Augmented recession vs. Faden group (Second row)|t-test, 2 sided|||||||0.02
70902287|NCT02413463|141292707|SUPERIORITY|||||||0.03||||||This is the calculated p-value for the postoperative angle disparity in the Augmented Group Vs. Faden Group|t-test, 2 sided|||||||0.03
70902288|NCT02413463|141292708|SUPERIORITY||||||<|0.01||||||This is the calculated p-value for the intraoperative time in the Augmented Group Vs. Faden Group|t-test, 2 sided|||||||<0.01
70902289|NCT00125593|141292713|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.83||||0.0021|TWO_SIDED|95.0|0.74|0.94|||Log Rank|||All analyses by intention to treat||0.94|0.74|0.0021
70902290|NCT00125593|141292714|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.85||||0.0012|TWO_SIDED|95.0|0.77|0.94|||Log Rank|||All analyses by intention to treat||0.94|0.77|0.0012
70902291|NCT00125593|141292715|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84||||0.001|TWO_SIDED|95.0|0.75|0.93|||Log Rank|||All analyses by intention to treat||0.93|0.75|0.001
70902292|NCT00125593|141292716|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92||||0.37|TWO_SIDED|95.0|0.76|1.11|||Log Rank|||All analyses by intention to treat||1.11|0.76|0.37
70902293|NCT00125593|141292717|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75||||0.01|TWO_SIDED|95.0|0.6|0.94|||Log Rank|||All analyses by intention to treat||0.94|0.60|0.01
70902294|NCT00125593|141292718|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79||||0.0036|TWO_SIDED|95.0|0.68|0.93|||Log Rank|||All analyses by intention to treat||0.93|0.68|0.0036
70902295|NCT00125593|141292719|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.97||||0.41|TWO_SIDED|95.0|0.89|1.05|||Log Rank|||All analyses by intention to treat||1.05|0.89|0.41
70902296|NCT01597505|141292720|NON_INFERIORITY|Surotomycin minus Vancomycin. For surotomycin to be non-inferior to vancomycin the lower bound of a 2-sided 95% CI for the difference between treatment groups had to be ≥ -10%.|Difference in percentage of participants|-4.6|||||TWO_SIDED|95.0|-11.0|1.9|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in percentage of participants||1.9|-11.0|
70902297|NCT01597505|141292721|SUPERIORITY|||||||0.832||||||Log-rank test of equality of survival times, stratified by age group (\< 75, \>= 75 years) and number of CDAD episodes (0, \>= 1). Significance cut-off = 0.05|Log Rank|||Stratified log-rank test p-value||||0.832
70902298|NCT01597505|141292722|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|-0.8|||||TWO_SIDED|95.0|-8.8|7.1|||||The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference, using the MRc stratum weights. Stratified by age group and number of CDAD episodes.|Difference in percentage of participants||7.1|-8.8|
70902299|NCT01597505|141292726|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|0.6|||||TWO_SIDED|95.0|-7.2|8.3|||||The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference, using the MRc stratum weights. Stratified by age group and number of CDAD episodes.|Difference in percentage of participants||8.3|-7.2|
70902300|NCT01597505|141292727|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|-3.5|||||TWO_SIDED|95.0|-10.0|3.0|||||The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference, using the MRc stratum weights. Stratified by age group and number of CDAD episodes.|Difference in percentage of participants||3.0|-10.0|
70902301|NCT01597505|141292728|SUPERIORITY|Surotomycin was superior to vancomycin if the p-value was less than 0.05||||||0.431||||||Log-rank test of equality of survival times, stratified by age group (\< 75, \>= 75 years) and number of CDAD episodes (0, \>= 1). Significance cut-off = 0.05|Log Rank|||Stratified Log-Rank p-Value||||0.431
70902302|NCT01597505|141292729|SUPERIORITY|Surotomycin was superior to vancomycin if the p-value was less than 0.05||||||0.011||||||Log-rank test of equality of survival times, stratified by age group (\< 75, \>= 75 years) and number of CDAD episodes (0, \>= 1). Significance cut-off = 0.05|Log Rank|||Stratified Log-Rank p-Value||||0.011
70902303|NCT01597505|141292730|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|2.2|||||TWO_SIDED|95.0|-10.7|14.8|||||Treatment group percentages were stratified by age group (\< 75, ≥ 75) and number of previous CDAD episodes (0, ≥ 1). The 95% CIs were stratified Wilson intervals for the treatment group percentages.|Difference in percentage of participants||14.8|-10.7|
70902304|NCT01597505|141292731|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|-2.4|||||TWO_SIDED|95.0|-7.8|3.0|||||Treatment group proportions were stratified by age group (\< 75, ≥ 75) and number of previous CDAD episodes (0, ≥1). The 95% CIs were stratified Wilson intervals for the treatment group proportions.|Difference in percentage of participants||3.0|-7.8|
70902305|NCT01597505|141292732|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|14.6|||||TWO_SIDED|95.0|-2.7|30.7|||||Treatment group percentages were stratified by age group (\< 75, ≥ 75) and number of previous CDAD episodes (0, ≥ 1). The 95% CIs were stratified Wilson intervals for the treatment group percentages.|Difference in percentage of participants||30.7|-2.7|
70902306|NCT01597505|141292733|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|4.3|||||TWO_SIDED|95.0|-4.2|12.7|||||Treatment group proportions were stratified by age group (\< 75, ≥ 75) and number of previous CDAD episodes (0, ≥1). The 95% CIs were stratified Wilson intervals for the treatment group proportions.|Difference in percentage of participants||12.7|-4.2|
70902307|NCT00895622|141292760|OTHER||Kappa statistic|0.79|||<|0.0001|TWO_SIDED|95.0|0.71|0.87|||Z test|||"The Kappa (κ) coefficient was used to assess the measure of agreement between the reviewers. κ can be interpreted as follows (κ / Agreement):~\< 0 / Less than chance agreement; 0.01-0.20 / Slight agreement; 0.21-0.40 / Fair agreement; 0.41-0.60 / Moderate agreement; 0.61-0.80 / Substantial agreement; 0.81-0.99 / Almost perfect agreement.~The asymptotic test of the null hypothesis: κ=0 will be performed using the Z-statistic to determine the strength of agreement."||0.87|0.71|<0.0001
70902308|NCT02237508|141292773|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|138.87|||<|0.001|TWO_SIDED|90.0|129.09|149.39|||Mixed Models Analysis|||||149.39|129.09|<0.001
70902309|NCT02237508|141292773|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|136.18|||<|0.001|TWO_SIDED|90.0|126.13|147.04|||Mixed Models Analysis|||||147.04|126.13|<0.001
70902310|NCT02237508|141292774|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|119.73||||0.001|TWO_SIDED|90.0|109.4|131.03|||Mixed Models Analysis|||||131.03|109.40|0.001
70902311|NCT02237508|141292774|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|129.62|||<|0.001|TWO_SIDED|90.0|117.33|143.2|||Mixed Models Analysis|||||143.20|117.33|<0.001
70902312|NCT02237508|141292775|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|218.13|||<|0.001|TWO_SIDED|90.0|194.02|245.24|||Mixed Models Analysis|||||245.24|194.02|<0.001
70902313|NCT02237508|141292775|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|200.66|||<|0.001|TWO_SIDED|90.0|174.3|231.01|||Mixed Models Analysis|||||231.01|174.30|<0.001
70902314|NCT02237508|141292776|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|126.17|||<|0.001|TWO_SIDED|90.0|115.93|137.32|||Mixed Models Analysis|||||137.32|115.93|<0.001
70902315|NCT02237508|141292776|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|117.08||||0.004|TWO_SIDED|90.0|107.05|128.05|||Mixed Models Analysis|||||128.05|107.05|0.004
70902316|NCT01905046|141292825|SUPERIORITY||Odds Ratio (OR)|0.97||||0.951|TWO_SIDED|95.0|0.36|2.62|||Chi-squared|||||2.62|0.36|0.951
70902317|NCT03489057|141292838|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|||||||0.19
70902318|NCT03489057|141292852|SUPERIORITY|||||||0.48|||||||Mixed Models Analysis|||||||0.48
70902319|NCT02277743|141292878|SUPERIORITY||difference in percentages|27.7|||<|0.0001|TWO_SIDED|95.0|20.18|35.17||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||35.17|20.18|< 0.0001
70902320|NCT02277743|141292878|SUPERIORITY||difference in percentages|27.0|||<|0.0001|TWO_SIDED|95.0|19.47|34.44||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||34.44|19.47|< 0.0001
70902321|NCT02277743|141292879|SUPERIORITY||difference in percentages|36.6|||<|0.0001|TWO_SIDED|95.0|28.58|44.63||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||44.63|28.58|< 0.0001
70902322|NCT02277743|141292879|SUPERIORITY||difference in percentages|37.7|||<|0.0001|TWO_SIDED|95.0|29.7|45.77||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||45.77|29.70|< 0.0001
70902323|NCT02277743|141292880|SUPERIORITY||difference in percentages|28.6|||<|0.0001|TWO_SIDED|95.0|20.64|36.52||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||36.52|20.64|< 0.0001
70902324|NCT02277743|141292880|SUPERIORITY||difference in percentages|28.0|||<|0.0001|TWO_SIDED|95.0|19.94|36.13||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||36.13|19.94|< 0.0001
70902325|NCT02277743|141292881|SUPERIORITY||difference in percentages|29.6|||<|0.0001|TWO_SIDED|95.0|21.36|37.88||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||37.88|21.36|< 0.0001
70902326|NCT02277743|141292881|SUPERIORITY||difference in percentages|34.5|||<|0.0001|TWO_SIDED|95.0|26.08|42.84||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||42.84|26.08|< 0.0001
70902327|NCT02277743|141292882|SUPERIORITY||Least square (LS) mean difference|-24.9|||<|0.0001|TWO_SIDED|95.0|-32.26|-17.52||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-17.52|-32.26|< 0.0001
70902328|NCT02277743|141292882|SUPERIORITY||LS mean difference|-22.8|||<|0.0001|TWO_SIDED|95.0|-30.33|-15.33||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-15.33|-30.33|< 0.0001
70902329|NCT02277743|141292883|SUPERIORITY||difference in percentages|9.8||||0.0012|TWO_SIDED|95.0|3.95|15.71||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||15.71|3.95|0.0012
70902330|NCT02277743|141292883|SUPERIORITY||difference in percentages|17.3|||<|0.0001|TWO_SIDED|95.0|10.57|23.93||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||23.93|10.57|< 0.0001
70902331|NCT02277743|141292884|SUPERIORITY||difference in percentages|6.1||||0.0097|TWO_SIDED|95.0|1.49|10.68||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||10.68|1.49|0.0097
70902332|NCT02277743|141292884|SUPERIORITY||difference in percentages|6.2||||0.0094|TWO_SIDED|95.0|1.45|10.86||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||10.86|1.45|0.0094
70902333|NCT02277743|141292885|SUPERIORITY||LS mean difference|-1.75|||<|0.0001|TWO_SIDED|95.0|-2.236|-1.26||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-1.260|-2.236|< 0.0001
70902334|NCT02277743|141292885|SUPERIORITY||LS mean difference|-1.69|||<|0.0001|TWO_SIDED|95.0|-2.189|-1.186||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-1.186|-2.189|< 0.0001
70902335|NCT02277743|141292886|SUPERIORITY||LS mean difference|-34.6|||<|0.0001|TWO_SIDED|95.0|-42.35|-26.88||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-26.88|-42.35|< 0.0001
70902336|NCT02277743|141292886|SUPERIORITY||LS mean difference|-34.4|||<|0.0001|TWO_SIDED|95.0|-42.17|-26.56||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-26.56|-42.17|< 0.0001
70902337|NCT02277743|141292887|SUPERIORITY||difference in percentages|44.2|||<|0.0001|TWO_SIDED|95.0|35.91|52.48||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||52.48|35.91|< 0.0001
70902338|NCT02277743|141292887|SUPERIORITY||difference in percentages|36.4|||<|0.0001|TWO_SIDED|95.0|27.9|44.96||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||44.96|27.90|< 0.0001
70902339|NCT02277743|141292888|SUPERIORITY||difference in percentages|28.1|||<|0.0001|TWO_SIDED|95.0|20.96|35.29||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||35.29|20.96|< 0.0001
70902340|NCT02277743|141292888|SUPERIORITY||difference in percentages|25.6|||<|0.0001|TWO_SIDED|95.0|18.51|32.68||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||32.68|18.51|< 0.0001
70902341|NCT02277743|141292889|SUPERIORITY||LS mean difference|-17.92|||<|0.0001|TWO_SIDED|95.0|-22.487|-13.353||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-13.353|-22.487|< 0.0001
70902342|NCT02277743|141292889|SUPERIORITY||LS mean difference|-18.89|||<|0.0001|TWO_SIDED|95.0|-23.125|-14.65||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-14.650|-23.125|< 0.0001
70902343|NCT02277743|141292890|SUPERIORITY||LS mean difference|-28.7|||<|0.0001|TWO_SIDED|95.0|-35.79|-21.54||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-21.54|-35.79|< 0.0001
70902344|NCT02277743|141292890|SUPERIORITY||LS mean difference|-28.0|||<|0.0001|TWO_SIDED|95.0|-35.09|-20.87||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-20.87|-35.09|< 0.0001
70902345|NCT02277743|141292891|SUPERIORITY||LS mean difference|-4.0|||<|0.0001|TWO_SIDED|95.0|-5.16|-2.8||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-2.80|-5.16|< 0.0001
70902346|NCT02277743|141292891|SUPERIORITY||LS mean difference|-3.7|||<|0.0001|TWO_SIDED|95.0|-4.87|-2.49||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-2.49|-4.87|< 0.0001
70902347|NCT02277743|141292892|SUPERIORITY||LS mean difference|-6.5|||<|0.0001|TWO_SIDED|95.0|-8.02|-5.01||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-5.01|-8.02|< 0.0001
70902348|NCT02277743|141292892|SUPERIORITY||LS mean difference|-5.9|||<|0.0001|TWO_SIDED|95.0|-7.44|-4.32||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-4.32|-7.44|< 0.0001
70902349|NCT02277743|141292893|SUPERIORITY||LS mean difference|-2.2||||0.0006|TWO_SIDED|95.0|-3.44|-0.95||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-0.95|-3.44|0.0006
70902350|NCT02277743|141292893|SUPERIORITY||LS mean difference|-2.2||||0.0003|TWO_SIDED|95.0|-3.46|-1.03||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-1.03|-3.46|0.0003
70902351|NCT02277743|141292894|SUPERIORITY||LS mean difference|-27.0|||<|0.0001|TWO_SIDED|95.0|-35.04|-18.91||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-18.91|-35.04|< 0.0001
70902352|NCT02277743|141292894|SUPERIORITY||LS mean difference|-25.6|||<|0.0001|TWO_SIDED|95.0|-33.06|-18.12||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-18.12|-33.06|< 0.0001
70902353|NCT02277743|141292895|SUPERIORITY||LS mean difference|-16.5|||<|0.0001|TWO_SIDED|95.0|-21.08|-11.9||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-11.90|-21.08|< 0.0001
70902354|NCT02277743|141292895|SUPERIORITY||LS mean difference|-15.1|||<|0.0001|TWO_SIDED|95.0|-19.62|-10.5||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-10.50|-19.62|< 0.0001
70902355|NCT01622010|141292905|EQUIVALENCE|P value 0.05 used||||||0.487|||||||Chi-squared|||||||0.487
70902356|NCT01622010|141292907|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|a non-inferiority margin calculation was not performed for this study prior to its start.||||||0.628|||||||Fisher Exact|||Null hypothesis: Standard care is better than standard care with video enhancement.||||0.628
70902357|NCT01622010|141292908|EQUIVALENCE|P Value 0.05 used||||||0.647|||||||Chi-squared|||||||0.647
70902358|NCT03976466|141292932|SUPERIORITY||Risk Ratio (RR)|0.049|||<|0.05|TWO_SIDED|95.0|0.015|0.168|||Chi-squared, Corrected||For the Relative risk the control Study group was the numerator and control group denominator. In the 2X2 contingency table the rows correspond to groups and columns for the presence or abscence of periprosthetic infection.|"H0.- There is no significant difference in the incidence of periprosthetic infection in patients with non-modifiable risk factors and prophylactic application of antibiotic loaded calcium sulfate compared with patients without prophylactic treatment with calcium sulfate.~The presence of periprosthetic infection in both groups was evaluated by chi2 and Lambda tests for dichotomous nominal and qualitative variables with longitudinal direction and relative risk factor test."||0.168|0.015|<0.05
70902359|NCT03976466|141292933|SUPERIORITY||||||<|0.01||||||The statistical test of t was performed for the variable length of hospital stay, finding a significant difference with a p value \< 0.01|t-test, 2 sided|||Lenght of stay was the variable that compares both groups and was a continous variable (t-test).||||<0.01
70902360|NCT00733499|141292934|OTHER|||||||0.9478|||||||t-test, 2 sided|||||||0.9478
70902361|NCT00733499|141292935|OTHER|||||||0.549|||||||t-test, 2 sided|||||||0.5490
70902362|NCT00733499|141292936|OTHER|||||||0.5312|||||||t-test, 2 sided|||||||0.5312
70902363|NCT00733499|141292937|OTHER|||||||0.3549|||||||t-test, 2 sided|||||||0.3549
70902364|NCT00733499|141292938|OTHER|||||||0.0513|||||||t-test, 2 sided|||||||0.0513
70902365|NCT00733499|141292939|OTHER|||||||0.0629|||||||t-test, 2 sided|||||||0.0629
70902366|NCT00733499|141292940|OTHER|||||||0.0327|||||||t-test, 2 sided|||||||0.0327
70902367|NCT00733499|141292941|OTHER|||||||0.0883|||||||t-test, 2 sided|||||||0.0883
70902368|NCT00733499|141292942|OTHER|||||||0.6801|||||||Wilcoxon (Mann-Whitney)|||||||0.6801
70902369|NCT00733499|141292943|OTHER|||||||0.4779|||||||t-test, 2 sided|||||||0.4779
70902370|NCT00733499|141292944|OTHER|||||||0.8007|||||||t-test, 2 sided|||||||0.8007
70902371|NCT00733499|141292945|OTHER|||||||0.3317|||||||t-test, 2 sided|||||||0.3317
70902372|NCT00733499|141292946|OTHER|||||||0.8955|||||||t-test, 2 sided|||||||0.8955
70902373|NCT00733499|141292947|OTHER|||||||0.2116|||||||t-test, 2 sided|||||||0.2116
70902374|NCT00733499|141292948|OTHER|||||||0.4776|||||||t-test, 2 sided|||||||0.4776
70902375|NCT00733499|141292950|OTHER|||||||0.2935|||||||t-test, 2 sided|||||||0.2935
70902376|NCT00733499|141292951|OTHER|||||||0.0062|||||||Wilcoxon (Mann-Whitney)|||||||0.0062
70902377|NCT00733499|141292952|OTHER|||||||0.6896|||||||t-test, 2 sided|||||||0.6896
70902378|NCT00733499|141292953|OTHER|||||||0.1076|||||||t-test, 2 sided|||||||0.1076
70902379|NCT00733499|141292954|OTHER|||||||0.9042|||||||t-test, 2 sided|||||||0.9042
70902380|NCT00733499|141292955|OTHER|||||||0.9637|||||||t-test, 2 sided|||||||0.9637
70902381|NCT00733499|141292956|OTHER|||||||0.0485|||||||t-test, 2 sided|||||||0.0485
70902382|NCT00733499|141292957|OTHER|||||||0.9813|||||||t-test, 2 sided|||||||0.9813
70902383|NCT01552954|141292961|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||for albuminuria changes from week 8 at week 16 (week 8 - week 16)|t-test, 2 sided|||Differences with two-tailed P\<0.05 were considered statistically significant.||||0.006
70902384|NCT01552954|141292961|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED|||||for 24-hour urine albumin excretion between 8 weeks and 16 weeks|Mixed Models Analysis|||||||0.99
70902385|NCT01552954|141292961|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||for 24-hour urine albumin excretion between 8 weeks and 16 weeks in intensive education group|Mixed Models Analysis|||||||0.001
70902386|NCT01552954|141292962|SUPERIORITY_OR_OTHER|||||||0.187|TWO_SIDED|||||for hemoglobin changes from week 0 at week 16 (week 0 - week 16)|t-test, 2 sided|||||||0.187
70902387|NCT01552954|141292963|SUPERIORITY_OR_OTHER|||||||0.001||||||for changes from week 8 at week 16 (week 8 - week 16)|t-test, 2 sided|||||||0.001
70902388|NCT01552954|141292964|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||for sBP changes from week 8 at week 16 (week 8 - week 16)|t-test, 2 sided|||||||>0.05
70902389|NCT01552954|141292964|SUPERIORITY_OR_OTHER|||||||0.585|TWO_SIDED|||||for dBP changes from week 8 at week 16 (week 8 - week 16)|t-test, 2 sided|||||||0.585
70902390|NCT04843930|141292967|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.54|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 261.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.54
70902391|NCT04843930|141292968|SUPERIORITY||Mean Difference (Final Values)|2.83||||0.04|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 239.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis."||||0.04
70902392|NCT04843930|141292969|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.79|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 229.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.79
70902393|NCT04843930|141292970|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.45|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 269.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.45
70902394|NCT04843930|141292971|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.02|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 236.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.02
70902395|NCT04843930|141292972|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.96|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 257.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.96
70902396|NCT04843930|141292973|SUPERIORITY||Mean Difference (Final Values)|2.78||||0.04|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 262.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.04
70902397|NCT04843930|141292974|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.6|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 227.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.60
70963636|NCT02273726|141432205|NON_INFERIORITY|Non-inferiority was established if the lower bound of the 2-sided 95% CI for the treatment difference for the responder rates (roxadustat minus epoetin alfa) calculated based on the Miettinen \& Nurminen approach, adjusting for stratification factors, was greater than -15%.|Responder Rate Difference|7.6|||||TWO_SIDED|95.0|0.9|14.3||||||For the difference of responder rates between 2 treatment groups, the CI analyzed was from the Miettinen \& Nurminen approach adjusting for randomization stratification factors.||14.3|0.9|
70902398|NCT04843930|141292975|SUPERIORITY||Mean Difference (Final Values)|3.77||||0.06|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 1, 89.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.06
70902399|NCT04843930|141292976|SUPERIORITY||Mean Difference (Final Values)|4.37||||0.04|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 1, 73.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.04
70902400|NCT00947661|141292984|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of covariance included treatment, site, and intraocular pressure group as a covariate. Two-sided 95% confidence interval for the difference between treatment groups in estimated mean change from baseline lease square means was computed for each time point. Non-inferiority of SPARC drug relative to Reference was established if: 95% confidence interval included 0, the upper limit of the 95% CI was \<1.5, and upper limit of 95% CI was \<1 at most (at least 7 of 12) time point.|||||<|0.01|TWO_SIDED||||||ANCOVA|||||||<0.01
70902401|NCT02552238|141292988|SUPERIORITY|||||||0.0067|||||||McNemar|||Sensitivity: superiority test comparing CE-DSE and UE-DSE based on the difference||||0.0067
70902402|NCT02552238|141292988|SUPERIORITY||||||<|0.0001|||||||McNemar|||Specificity: superiority test comparing CE-DSE and UE-DSE based on the difference||||<0.0001
70902403|NCT02036645|141292993|SUPERIORITY_OR_OTHER||Slope|0.93|||||TWO_SIDED|95.0|0.82|1.04|||Regression, Linear||Since an Estimation approach was taken for the statistical analysis, no p-values were calculated|||1.04|0.82|
70902404|NCT02036645|141292993|SUPERIORITY_OR_OTHER||Slope|1.01|||||TWO_SIDED|95.0|0.71|1.3|||Regression, Linear||Since an Estimation approach was taken for the statistical analysis, no p-values were calculated|||1.30|0.71|
70902405|NCT02036645|141292994|SUPERIORITY_OR_OTHER||Slope|0.9|||||TWO_SIDED|95.0|0.81|0.98|||Regression, Linear||Since an Estimation approach was taken for the statistical analysis, no p-values were calculated|||0.98|0.81|
70902406|NCT02036645|141292994|SUPERIORITY_OR_OTHER||Slope|0.96|||||TWO_SIDED|95.0|0.65|1.27|||Regression, Linear||Since an Estimation approach was taken for the statistical analysis, no p-values were calculated|||1.27|0.65|
70902407|NCT01874145|141293018|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.501|STANDARD_ERROR_OF_MEAN|0.101||0.0006|TWO_SIDED|95.0|0.338|0.743||The overall significance level for this study was 5% using 2-tailed test.|Poisson regression model|Natural log of treatment duration was an offset variable; adjusted for baseline EDSS, treatment group, age, sex, # relapses 2 years prior to screening|GA 40 mg/mL TIW treatment group / GA 20 mg/mL QD treatment group.|Adjusted mean estimates were adjusted estimates of event rates within treatment group. The treatment effect parameter estimate was a risk ratio of the GA 40 mg/mL TIW treatment group divided by the GA 20 mg/mL QD treatment group. The p value tested whether the risk ratio was significantly different from 1.||0.743|0.338|0.0006
70902408|NCT01874145|141293020|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5|STANDARD_ERROR_OF_MEAN|0.101||0.0006|TWO_SIDED|95.0|0.337|0.742||The overall significance level for this study was 5% using 2-tailed test.|Poisson regression model|Natural log of treatment duration was an offset variable; adjusted for baseline EDSS, treatment group, age, sex, # relapses 2 years prior to screening|GA 40 mg/mL TIW treatment group / GA 20 mg/mL QD treatment group|Adjusted mean estimates were adjusted estimates of event rates within treatment group. The treatment effect parameter estimate was a risk ratio of the GA 40 mg/mL TIW treatment group divided by the GA 20 mg/mL QD treatment group. The p value tested whether the risk ratio was significantly different from 1.||0.742|0.337|0.0006
70902409|NCT01874145|141293021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.058|STANDARD_ERROR_OF_MEAN|1.206||0.0897|TWO_SIDED|95.0|-4.438|0.322||The overall significance level for this study was 5% using 2-tailed test.|ANCOVA|In addition to treatment group, month (categorical), treatment-by-month interaction and score at baseline were used as covariates.|GA 40 mg/mL TIW treatment group vs. GA 20 mg/mL QD treatment group.|"To control for type 1 errors, secondary variables were analyzed only if analysis of the primary variable was statistically significant. Gate-keeping procedures offered further control with this hierarchy:~1. the rate of ISRs~2. change from baseline to month 4 (change - M4) in MSIS-20 physical wellbeing~3. change - M4 in MSIS-20 psychological wellbeing~4. change - M4 in TSQM-9 convenience~5. change - M4 in TSQM-9 overall satisfaction"||0.322|-4.438|0.0897
70902410|NCT03238300|141293064|SUPERIORITY||partial eta squared|0.02|||>|0.05|TWO_SIDED|95.0|0.0|0.22||P-value \>0.05 for main effect of medication (N-acetylcysteine vs. placebo)|Mixed Models Analysis|Random intercepts were used||"With 31 participants, the study has 99% power to detect such effects on glutamate levels (calculated based on d =1.13 \[reported in Schmaal et al., 2012\], α = 0.05, two-tailed).~We used linear mixed effects models with random intercepts with medication, visit, and sequence. Baseline metabolite levels and brain tissue composition \[GM:BM = GM/(GM+WM)\], cannabis use (days), and alcohol use disorder status (Yes/No) were included as covariates."||0.22|0.00|>0.05
70902411|NCT03238300|141293065|SUPERIORITY||||||>|0.05||||||P-value \>0.05 for main effect of medication (N-acetylcysteine vs. placebo) for all ROIs.|Mixed Models Analysis|Random intercepts were used for all models.||Contrast of interest was alcohol beverages vs. non-alcohol beverages. We used linear mixed effects models with random intercepts with medication, visit, and sequence. Baseline reactivity levels for each ROI, cannabis use (days), and an alcohol use covariate (quantity, frequency, AUD status, or AUD severity - depending on which best fit the model) were included as covariates. ROIs included were (left and right hemisphere): amygdala, caudate, insula, putamen, and nucleus accumbens.||||>0.05
70902412|NCT04064242|141293066|OTHER|A Bayesian model for repeated measurements including data collected at Weeks 4, 8, 12 and 16 was applied to compare FVC between CMK389 and placebo groups.|Posterior estimate treatment difference|-1.49|STANDARD_DEVIATION|1.62||0.1804|TWO_SIDED|80.0|-3.56|0.6|||Bayesian analysis|Posterior probability that treatment is better than placebo.|80% credible intervals are reported on the treatment difference|||0.60|-3.56|0.1804
70902413|NCT04064242|141293072|SUPERIORITY||Median Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.045||0.783|TWO_SIDED|80.0|-0.09|0.02|||Mixed effects Model for Repeated Measure||Treatment difference (CMK389-placebo)|||0.02|-0.09|0.783
70902414|NCT04064242|141293073|SUPERIORITY||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|0.664||0.608|TWO_SIDED|80.0|-1.05|0.68|||Mixed effects Model for Repeated Measure||Treatment difference (CMK389-placebo)|||0.68|-1.05|0.608
70902415|NCT04064242|141293074|SUPERIORITY||Median Difference (Net)|0.71|STANDARD_ERROR_OF_MEAN|13.126||0.479|TWO_SIDED|80.0|-16.35|17.76|||Mixed effects Model for Repeated Measure||Treatment difference (CMK389-placebo)|||17.76|-16.35|0.479
70902416|NCT00201864|141293087|SUPERIORITY_OR_OTHER|||||||0.9102|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.9102
70902417|NCT00708435|141293134|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was -(minus)10%. If the lower limit of the 2-sided 95% CI was \>-10%, then the null-hypothesis was rejected and it was concluded that Beriplex was non-inferior to plasma.~The sample size estimation assumed that hemostatic efficacy would be rated 'effective' in 85% of participants in the plasma group and 90% of participants in the Beriplex group. The power to show non-inferiority with these assumptions was greater than 80% for two treatment groups of 83 participants."|Difference in effective hemostasis (%)|7.1|||||TWO_SIDED|95.0|-5.8|19.9||Both primary endpoints had to be non-inferior for Beriplex to be non-inferior. No P-value is entered as non-inferiority was assessed via the 95% CI calculation for the difference (Beriplex minus plasma) in the % of subjects with effective hemostasis.|95% confidence interval|Farrington and Manning's method was used to estimate the 95% CI for the difference in the percentage of participants with hemostasis.|Both primary endpoints had to be non-inferior for Beriplex to be non-inferior. There is no P-value as non-inferiority was assessed via the 95% CI calculation for the difference (Beriplex minus plasma) in the % of subjects with effective hemostasis.|The analysis of hemostatic efficacy was via calculation of the 95% confidence interval (CI) for the difference (Beriplex minus plasma) in the percentage of participants with effective hemostasis.||19.9|-5.8|
70902418|NCT00708435|141293135|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was -(minus)10%. If the lower limit of the 2-sided 95% CI was \>-10%, then the null-hypothesis was rejected and it was concluded that Beriplex was non-inferior to plasma.~The sample size estimation assumed that hemostatic efficacy would be rated 'effective' in 85% of participants in the plasma group and 90% of participants in the Beriplex group. The power to show non-inferiority with these assumptions was greater than 80% for two treatment groups of 83 participants."|Difference in the decrease of INR (%)|52.6|||||TWO_SIDED|95.0|39.4|65.9||Both primary endpoints had to be non-inferior for Beriplex to be non-inferior. No P-value is entered as non-inferiority was assessed via the 95% CI for the difference (Beriplex minus plasma) in the % of subjects with a rapid decrease of the INR.|95% confidence interval|Farrington and Manning's method was used to estimate the 95% CI for the difference in the percentage of participants with a rapid decrease of the INR.|Both primary endpoints had to be non-inferior for Beriplex to be non-inferior. There is no P-value as non-inferiority was assessed via the 95% CI for the difference (Beriplex minus plasma) in the % of subjects with a rapid decrease of the INR.|The analysis of the percentage of participants who had a rapid decrease of the INR was via calculation of the 95% confidence interval (CI) for the difference (Beriplex minus plasma) in the percentage of participants with a rapid decrease of the INR.||65.9|39.4|
70902419|NCT01737684|141293149|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.27|||||TWO_SIDED|90.0|0.96|1.67|||ANCOVA|||||1.67|0.96|
70902420|NCT01737684|141293152|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.35|||||TWO_SIDED|90.0|0.88|2.06|||ANCOVA|||||2.06|0.88|
70902421|NCT01691521|141293155|SUPERIORITY_OR_OTHER||Rate Ratio|0.53|||<|0.001|TWO_SIDED|95.0|0.4|0.72||Hochberg procedure with a gamma parameter of 1 used for multiplicity adjustment.|Negative binomial model||Number of exacerbations per year in the mepolizumab 75mg IV arm divided by the number of exacerbations per year in the placebo arm.|||0.72|0.40|<0.001
70902422|NCT01691521|141293155|SUPERIORITY_OR_OTHER||Rate Ratio|0.47|||<|0.001|TWO_SIDED|95.0|0.35|0.64||Hochberg procedure with a gamma parameter of 1 used for multiplicity adjustment.|Negative binomial model||Number of exacerbations per year in the mepolizumab 100 mg SC arm divided by the number of exacerbations per year in the placebo arm.|||0.64|0.35|<0.001
70902423|NCT04503096|141293161|OTHER|To monitor safety, paired t-tests were conducted to test for pre- to post-treatment differences in global cognition (i.e., MoCA z-scores).||||||0.725|||||||t-test, 2 sided|||||||0.725
70902424|NCT04503096|141293165|OTHER|Paired t-tests were conducted to test for pre- to post-treatment changes in depression using HAM-D raw scores.||||||0.605|||||||t-test, 2 sided|||||||.605
70902425|NCT04503096|141293166|OTHER|Paired t-tests were conducted to test for pre- to post-treatment changes in depression using GDS raw scores.||||||0.897|||||||t-test, 2 sided|||||||.897
70902426|NCT04503096|141293167|OTHER|Paired t-tests were conducted to test for pre- to post-treatment changes in cognition using Fluid Cognition Composite Scores.|||||<|0.001|||||||t-test, 2 sided|||||||< .001
70902427|NCT01480596|141293168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.84|STANDARD_ERROR_OF_MEAN|1.592||0.256|TWO_SIDED|95.0|-5.08|1.4|||Mixed Models Analysis||Standard error of mean is for adjusted difference.|||1.40|-5.08|0.256
70902428|NCT01480596|141293169|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.81||||0.082||95.0|0.87|19.02|||exact methods|||||19.02|0.87|0.082
70902429|NCT01480596|141293170|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55||||0.827||95.0|0.05|4.35|||exact methods|||||4.35|0.05|0.827
70902430|NCT01480596|141293171|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.51||||0.184|TWO_SIDED|95.0|0.62|10.1|||Cochran-Mantel-Haenszel|||||10.10|0.62|0.184
70902431|NCT01480596|141293173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|1.228||0.175|TWO_SIDED|95.0|-4.2|0.8|||Mixed Models Analysis||Analysis for Week 28. Standard error of mean is for adjusted difference.|||0.80|-4.20|0.175
70902432|NCT01480596|141293173|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.31|STANDARD_ERROR_OF_MEAN|1.267||0.31|TWO_SIDED|95.0|-3.89|1.28|||Mixed Models Analysis||Analysis for Week 32. Standard error of mean is for adjusted difference.|||1.28|-3.89|0.310
70902433|NCT01480596|141293173|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.29|STANDARD_ERROR_OF_MEAN|1.272||0.081|TWO_SIDED|95.0|-4.88|0.3|||Mixed Models Analysis||Analysis for Week 36. Standard error of mean is for adjusted difference.|||0.30|-4.88|0.081
70902434|NCT01480596|141293174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|1.486||0.972|TWO_SIDED|95.0|-2.97|3.07|||Mixed Models Analysis||Standard error of mean is for adjusted difference.|||3.07|-2.97|0.972
70902435|NCT01480596|141293175|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||1|TWO_SIDED|95.0|0.26|5.48|||exact methods|||||5.48|0.26|1.000
70902436|NCT01480596|141293176|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.53|TWO_SIDED|95.0|0.03|2.89|||exact methods|||||2.89|0.03|0.530
70902437|NCT01480596|141293177|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.7||||0.175|TWO_SIDED|95.0|0.64|11.46|||Cochran-Mantel-Haenszel|||||11.46|0.64|0.175
70902438|NCT01480596|141293179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|1.245||0.423|TWO_SIDED|95.0|-3.56|1.53|||Mixed Models Analysis||Analysis for Week 28. Standard error of mean is for adjusted difference.|||1.53|-3.56|0.423
70902439|NCT01480596|141293179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|1.361||0.986|TWO_SIDED|95.0|-2.76|2.8|||Mixed Models Analysis||Analysis for Week 32. Standard error of mean is for adjusted difference.|||2.80|-2.76|0.986
70902440|NCT01480596|141293179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|1.43||0.848|TWO_SIDED|95.0|-3.21|2.65|||Mixed Models Analysis||Analysis for Week 36. Standard error of mean is for adjusted difference.|||2.65|-3.21|0.848
70902441|NCT01480596|141293185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.707||0.483|TWO_SIDED|95.0|-1.94|0.93|||Mixed Models Analysis||Statistical analysis is presented for Week 12. Standard error of mean is for adjusted mean difference.|||0.93|-1.94|0.483
70902442|NCT01480596|141293185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.844||0.711|TWO_SIDED|95.0|-2.03|1.4|||Mixed Models Analysis||Statistical analysis is presented for Week 24. Standard error of mean is for adjusted mean difference.|||1.40|-2.03|0.711
70902443|NCT01480596|141293186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75|STANDARD_ERROR_OF_MEAN|0.757||0.028|TWO_SIDED|95.0|-3.3|-0.2|||Mixed Models Analysis||Analysis for Week 28. Standard error of mean is for adjusted difference.|||-0.20|-3.30|0.028
70902444|NCT01480596|141293186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.887||0.756|TWO_SIDED|95.0|-2.1|1.55|||Mixed Models Analysis||Analysis for Week 32. Standard error of mean is for adjusted difference.|||1.55|-2.10|0.756
70902445|NCT01480596|141293186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.909||0.775|TWO_SIDED|95.0|-2.12|1.59|||Mixed Models Analysis||Analysis for Week 36. Standard error of mean is for adjusted difference.|||1.59|-2.12|0.775
70902446|NCT00818363|141293242|SUPERIORITY||LS Mean Difference|-0.64||||0.303|TWO_SIDED|95.0|-1.74|0.47|||ANCOVA|Includes treatment group and trial site as factors and age as a covariate.||||0.47|-1.74|0.303
70902447|NCT00818363|141293243|SUPERIORITY||LS Mean Difference|-10.25||||0.303|TWO_SIDED|95.0|-30.04|9.55|||ANCOVA|Includes treatment group and trial site as factors and age as a covariate.||||9.55|-30.04|0.303
70902448|NCT00988221|141293271|SUPERIORITY_OR_OTHER||Adjusted mean - Placebo|-22.3||||||||||The analysis was adjusted for the randomization stratification factors background use of methotrexate and background use of oral corticosteroids. The analysis was also adjusted for the pain visual analog scale score at Baseline.|ANOVA|||||||
70902449|NCT00988221|141293271|SUPERIORITY_OR_OTHER||Adjusted mean - Tocilizumab|-32.4||||||||||The analysis was adjusted for the randomization stratification factors background use of methotrexate and background use of oral corticosteroids. The analysis was also adjusted for the pain visual analog scale score at Baseline.|ANOVA|||||||
70902450|NCT00988221|141293271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.2||||0.0076|TWO_SIDED|95.0|-17.6|-2.7||The analysis was adjusted for the randomization stratification factors background use of methotrexate and background use of oral corticosteroids. The analysis was also adjusted for the pain visual analog scale score at Baseline.|ANOVA|||||-2.7|-17.6|0.0076
70902451|NCT00988221|141293272|SUPERIORITY_OR_OTHER||Weighted difference|18.0||||1|TWO_SIDED|95.0|5.0|32.0||1.000 is used here as the test was considered as not significant due to the break in the hierarchical testing chain.|Cochran-Mantel-Haenszel|The analysis was adjusted for the randomization stratification factors background use of methotrexate and background use of oral corticosteroids.||The analysis used the Cochran-Mantel-Haenszel test adjusted for the randomization stratification factors background use of methotrexate and background use of oral corticosteroids.||32|5|1.000
70902452|NCT00633919|141293291|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED|95.0|||||Linear mixed effect (LME) model|||The null hypothesis is the hypothesis of no difference and the alternative to the null hypothesis is the hypothesis of a difference.||||0.85
70902453|NCT00633919|141293292|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED|95.0|||||Linear mixed effect (LME) model|||The null hypothesis is the hypothesis of no difference and the alternative to the null hypothesis is the hypothesis of a difference.||||0.52
70902454|NCT00633919|141293293|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Proportional odds regression|||The null hypothesis is the hypothesis of no difference and the alternative to the null hypothesis is the hypothesis of a difference.||||>0.05
70902455|NCT00633919|141293294|SUPERIORITY_OR_OTHER|||||||0.0486||95.0|||||Proportional odds regression|||The null hypothesis is the hypothesis of no difference and the alternative to the null hypothesis is the hypothesis of a difference.||||0.0486
70902456|NCT00633919|141293295|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Proportional odds regression|||The null hypothesis is the hypothesis of no difference and the alternative to the null hypothesis is the hypothesis of a difference.||||>0.05
70902457|NCT04750655|141293308|OTHER|||||||1|||||||Kruskal-Wallis|||Used the Kruskal-Wallis (nonparametric one-way ANOVA), comparing all 3 arms. Note that for each individual, a single number (normalized read) is obtained.||||1
70963637|NCT02273726|141432206|NON_INFERIORITY|Non-inferiority was established if the lower bound of the 2-sided 95% CI for the treatment difference for the responder rates (roxadustat minus epoetin alfa) calculated based on the Miettinen \& Nurminen approach, adjusting for stratification factors, was greater than -15%.|Responder Rate Difference|2.7|||||TWO_SIDED|95.0|-4.3|9.7||||||For the difference of responder rates between 2 treatment groups, the CI analyzed was from the Miettinen \& Nurminen approach adjusting for randomization stratification factors.||9.7|-4.3|
70902458|NCT01216163|141293313|SUPERIORITY_OR_OTHER||Least-squares (LS) mean difference|17.68|||<|0.001|TWO_SIDED|95.0|13.08|22.27||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR), gender and treatment-by-baseline PSR terms.|ANOVA|||Treatment difference(Ibuprofen sodium - placebo) and 95 percent(%) confidence interval(CI):based on LS means from Analysis of Variance(ANOVA).Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:Ibuprofen sodium(IBU Na) versus(vs) Placebo(PBO), IBU Na vs Acetaminophen(APAP), APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.||22.27|13.08|<0.001
70902459|NCT01216163|141293313|SUPERIORITY_OR_OTHER||LS mean difference|4.96||||0.01|TWO_SIDED|95.0|1.21|8.72||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms.|ANOVA|||Treatment difference (Ibuprofen sodium - Acetaminophen) and 95% CI: based on LS means from ANOVA. Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:IBU Na vs PBO, IBU Na vs APAP, APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.||8.72|1.21|0.010
70902460|NCT01216163|141293313|SUPERIORITY_OR_OTHER||LS mean difference|12.71|||<|0.001|TWO_SIDED|95.0|8.12|17.3||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms.|ANOVA|||Treatment difference (Acetaminophen - Placebo) and 95% CI: based on LS means from ANOVA. Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:IBU Na vs PBO, IBU Na vs APAP, APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.||17.30|8.12|<0.001
70902461|NCT01216163|141293314|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|11.84|||<|0.001|TWO_SIDED|95.0|5.13|27.36||p-value was calculated using PH model with treatment, baseline PSR and gender terms.|Proportional hazards model|||Hazard Ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model. Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:IBU Na vs PBO, IBU Na vs APAP, APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.||27.36|5.13|<0.001
70902462|NCT01216163|141293314|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.468|TWO_SIDED|95.0|0.81|1.6||p-value was calculated using PH model with treatment, baseline PSR and gender terms.|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model. Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:IBU Na vs PBO, IBU Na vs APAP, APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.||1.60|0.81|0.468
70902463|NCT01216163|141293314|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|10.43|||<|0.001|TWO_SIDED|95.0|4.5|24.17||p-value was calculated using PH model with treatment, baseline PSR and gender terms.|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model. Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:IBU Na vs PBO, IBU Na vs APAP, APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.||24.17|4.50|<0.001
70902464|NCT01216163|141293315|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|14.06|||<|0.001|TWO_SIDED|95.0|6.02|32.8||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||32.80|6.02|<0.001
70902465|NCT01216163|141293315|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.323|TWO_SIDED|95.0|0.84|1.68||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.68|0.84|0.323
70902466|NCT01216163|141293315|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|11.81|||<|0.001|TWO_SIDED|95.0|5.06|27.59||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||27.59|5.06|<0.001
70902467|NCT01216163|141293316|SUPERIORITY_OR_OTHER||LS mean difference|0.53|||<|0.001|TWO_SIDED|95.0|0.24|0.83||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.83|0.24|<0.001
70902468|NCT01216163|141293316|SUPERIORITY_OR_OTHER||LS mean difference|0.2||||0.101|TWO_SIDED|95.0|-0.04|0.44||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.44|-0.04|0.101
70902469|NCT01216163|141293316|SUPERIORITY_OR_OTHER||LS mean difference|0.33||||0.029|TWO_SIDED|95.0|0.03|0.62||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.62|0.03|0.029
70902470|NCT01216163|141293316|SUPERIORITY_OR_OTHER||LS mean difference|1.44|||<|0.001|TWO_SIDED|95.0|1.01|1.87||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.87|1.01|<0.001
70902471|NCT01216163|141293316|SUPERIORITY_OR_OTHER||LS mean difference|0.24||||0.178|TWO_SIDED|95.0|-0.11|0.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.59|-0.11|0.178
70902472|NCT01216163|141293316|SUPERIORITY_OR_OTHER||LS mean difference|1.2|||<|0.001|TWO_SIDED|95.0|0.77|1.63||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.63|0.77|<0.001
70902473|NCT01216163|141293316|SUPERIORITY_OR_OTHER||LS mean difference|2.07|||<|0.001|TWO_SIDED|95.0|1.64|2.49||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.49|1.64|<0.001
70902474|NCT01216163|141293316|SUPERIORITY_OR_OTHER||LS mean difference|0.44||||0.014|TWO_SIDED|95.0|0.09|0.78||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.78|0.09|0.014
70902475|NCT01216163|141293316|SUPERIORITY_OR_OTHER||LS mean difference|1.63|||<|0.001|TWO_SIDED|95.0|1.21|2.06||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.06|1.21|<0.001
70902476|NCT01216163|141293316|SUPERIORITY_OR_OTHER||LS mean difference|2.25|||<|0.001|TWO_SIDED|95.0|1.79|2.7||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.70|1.79|<0.001
70902477|NCT01216163|141293316|SUPERIORITY_OR_OTHER||LS mean difference|0.37||||0.055|TWO_SIDED|95.0|-0.01|0.74||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.74|-0.01|0.055
70902478|NCT01216163|141293316|SUPERIORITY_OR_OTHER||LS mean difference|1.88|||<|0.001|TWO_SIDED|95.0|1.43|2.34||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.34|1.43|<0.001
70902479|NCT01216163|141293316|SUPERIORITY_OR_OTHER||LS mean difference|2.31|||<|0.001|TWO_SIDED|95.0|1.8|2.83||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.83|1.80|<0.001
70902480|NCT01216163|141293316|SUPERIORITY_OR_OTHER||LS mean difference|0.51||||0.019|TWO_SIDED|95.0|0.08|0.93||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.93|0.08|0.019
70902481|NCT01216163|141293316|SUPERIORITY_OR_OTHER||LS mean difference|1.81|||<|0.001|TWO_SIDED|95.0|1.29|2.32||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.32|1.29|<0.001
70902482|NCT01216163|141293316|SUPERIORITY_OR_OTHER||LS mean difference|2.1|||<|0.001|TWO_SIDED|95.0|1.53|2.66||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.66|1.53|<0.001
70902483|NCT01216163|141293316|SUPERIORITY_OR_OTHER||LS mean difference|0.59||||0.013|TWO_SIDED|95.0|0.13|1.05||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.05|0.13|0.013
70902484|NCT01216163|141293316|SUPERIORITY_OR_OTHER||LS mean difference|1.51|||<|0.001|TWO_SIDED|95.0|0.95|2.07||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.07|0.95|<0.001
70902485|NCT01216163|141293316|SUPERIORITY_OR_OTHER||LS mean difference|1.97|||<|0.001|TWO_SIDED|95.0|1.39|2.56||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.56|1.39|<0.001
70902486|NCT01216163|141293316|SUPERIORITY_OR_OTHER||LS mean difference|0.63||||0.01|TWO_SIDED|95.0|0.15|1.1||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.10|0.15|0.010
70902487|NCT01216163|141293316|SUPERIORITY_OR_OTHER||LS mean difference|1.35|||<|0.001|TWO_SIDED|95.0|0.77|1.93||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.93|0.77|<0.001
70902488|NCT01216163|141293316|SUPERIORITY_OR_OTHER||LS mean difference|1.54|||<|0.001|TWO_SIDED|95.0|0.95|2.14||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.14|0.95|<0.001
70902489|NCT01216163|141293316|SUPERIORITY_OR_OTHER||LS mean difference|0.42||||0.088|TWO_SIDED|95.0|-0.06|0.91||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.91|-0.06|0.088
70902490|NCT01216163|141293316|SUPERIORITY_OR_OTHER||LS mean difference|1.12|||<|0.001|TWO_SIDED|95.0|0.52|1.71||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.71|0.52|<0.001
70902491|NCT01216163|141293316|SUPERIORITY_OR_OTHER||LS mean difference|1.46|||<|0.001|TWO_SIDED|95.0|0.85|2.07||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.07|0.85|<0.001
70902492|NCT01216163|141293316|SUPERIORITY_OR_OTHER||LS mean difference|0.47||||0.061|TWO_SIDED|95.0|-0.02|0.97||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.97|-0.02|0.061
70902493|NCT01216163|141293316|SUPERIORITY_OR_OTHER||LS mean difference|0.98||||0.002|TWO_SIDED|95.0|0.38|1.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.59|0.38|0.002
70902494|NCT01216163|141293317|SUPERIORITY_OR_OTHER||LS mean difference|0.31|||<|0.001|TWO_SIDED|95.0|0.13|0.49||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.49|0.13|<0.001
70902495|NCT01216163|141293317|SUPERIORITY_OR_OTHER||LS mean difference|0.06||||0.387|TWO_SIDED|95.0|-0.08|0.21||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.21|-0.08|0.387
70902496|NCT01216163|141293317|SUPERIORITY_OR_OTHER||LS mean difference|0.25||||0.007|TWO_SIDED|95.0|0.07|0.42||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.42|0.07|0.007
70902497|NCT01216163|141293317|SUPERIORITY_OR_OTHER||LS mean difference|0.89|||<|0.001|TWO_SIDED|95.0|0.64|1.15||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.15|0.64|<0.001
70902498|NCT01216163|141293317|SUPERIORITY_OR_OTHER||LS mean difference|0.25||||0.019|TWO_SIDED|95.0|0.04|0.46||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.46|0.04|0.019
70902499|NCT01216163|141293317|SUPERIORITY_OR_OTHER||LS mean difference|0.64|||<|0.001|TWO_SIDED|95.0|0.38|0.9||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.90|0.38|<0.001
70902500|NCT01216163|141293317|SUPERIORITY_OR_OTHER||LS mean difference|1.3|||<|0.001|TWO_SIDED|95.0|1.01|1.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.59|1.01|<0.001
70902501|NCT01216163|141293317|SUPERIORITY_OR_OTHER||LS mean difference|0.33||||0.006|TWO_SIDED|95.0|0.09|0.57||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.57|0.09|0.006
70902502|NCT01216163|141293317|SUPERIORITY_OR_OTHER||LS mean difference|0.97|||<|0.001|TWO_SIDED|95.0|0.68|1.26||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.26|0.68|<0.001
70902503|NCT01216163|141293317|SUPERIORITY_OR_OTHER||LS mean difference|1.43|||<|0.001|TWO_SIDED|95.0|1.12|1.74||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.74|1.12|<0.001
70902504|NCT01216163|141293317|SUPERIORITY_OR_OTHER||LS mean difference|0.32||||0.014|TWO_SIDED|95.0|0.07|0.58||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.58|0.07|0.014
70902505|NCT01216163|141293317|SUPERIORITY_OR_OTHER||LS mean difference|1.11|||<|0.001|TWO_SIDED|95.0|0.8|1.42||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.42|0.80|<0.001
70902506|NCT01216163|141293317|SUPERIORITY_OR_OTHER||LS mean difference|1.43|||<|0.001|TWO_SIDED|95.0|1.09|1.78||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.78|1.09|<0.001
70902507|NCT01216163|141293317|SUPERIORITY_OR_OTHER||LS mean difference|0.31||||0.03|TWO_SIDED|95.0|0.03|0.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.59|0.03|0.030
70902508|NCT01216163|141293317|SUPERIORITY_OR_OTHER||LS mean difference|1.12|||<|0.001|TWO_SIDED|95.0|0.78|1.46||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.46|0.78|<0.001
70902509|NCT01216163|141293317|SUPERIORITY_OR_OTHER||LS mean difference|1.29|||<|0.001|TWO_SIDED|95.0|0.91|1.66||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.66|0.91|<0.001
70902510|NCT01216163|141293317|SUPERIORITY_OR_OTHER||LS mean difference|0.42||||0.007|TWO_SIDED|95.0|0.12|0.73||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.73|0.12|0.007
70902511|NCT01216163|141293317|SUPERIORITY_OR_OTHER||LS mean difference|0.87|||<|0.001|TWO_SIDED|95.0|0.49|1.24||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.24|0.49|<0.001
70902512|NCT01216163|141293317|SUPERIORITY_OR_OTHER||LS mean difference|1.27|||<|0.001|TWO_SIDED|95.0|0.89|1.65||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.65|0.89|<0.001
70902513|NCT01216163|141293317|SUPERIORITY_OR_OTHER||LS mean difference|0.45||||0.004|TWO_SIDED|95.0|0.15|0.76||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.76|0.15|0.004
70902514|NCT01216163|141293317|SUPERIORITY_OR_OTHER||LS mean difference|0.82|||<|0.001|TWO_SIDED|95.0|0.44|1.19||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.19|0.44|<0.001
70902515|NCT01216163|141293317|SUPERIORITY_OR_OTHER||LS mean difference|0.92|||<|0.001|TWO_SIDED|95.0|0.54|1.31||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.31|0.54|<0.001
70902516|NCT01216163|141293317|SUPERIORITY_OR_OTHER||LS mean difference|0.28||||0.084|TWO_SIDED|95.0|-0.04|0.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.59|-0.04|0.084
70902517|NCT01216163|141293317|SUPERIORITY_OR_OTHER||LS mean difference|0.65||||0.001|TWO_SIDED|95.0|0.27|1.03||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.03|0.27|0.001
70902518|NCT01216163|141293317|SUPERIORITY_OR_OTHER||LS mean difference|0.93|||<|0.001|TWO_SIDED|95.0|0.54|1.32||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.32|0.54|<0.001
70902519|NCT01216163|141293317|SUPERIORITY_OR_OTHER||LS mean difference|0.38||||0.02|TWO_SIDED|95.0|0.06|0.69||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.69|0.06|0.020
70902520|NCT01216163|141293317|SUPERIORITY_OR_OTHER||LS mean difference|0.56||||0.005|TWO_SIDED|95.0|0.17|0.94||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.94|0.17|0.005
70902521|NCT01216163|141293318|SUPERIORITY_OR_OTHER||LS mean difference|0.84|||<|0.001|TWO_SIDED|95.0|0.4|1.28||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.28|0.40|<0.001
70902522|NCT01216163|141293318|SUPERIORITY_OR_OTHER||LS mean difference|0.27||||0.148|TWO_SIDED|95.0|-0.1|0.63||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.63|-0.10|0.148
70902523|NCT01216163|141293318|SUPERIORITY_OR_OTHER||LS mean difference|0.57||||0.011|TWO_SIDED|95.0|0.13|1.02||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.02|0.13|0.011
70902524|NCT01216163|141293318|SUPERIORITY_OR_OTHER||LS mean difference|2.34|||<|0.001|TWO_SIDED|95.0|1.68|2.99||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.99|1.68|<0.001
70902525|NCT01216163|141293318|SUPERIORITY_OR_OTHER||LS mean difference|0.49||||0.071|TWO_SIDED|95.0|-0.04|1.03||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.03|-0.04|0.071
70902526|NCT01216163|141293318|SUPERIORITY_OR_OTHER||LS mean difference|1.84|||<|0.001|TWO_SIDED|95.0|1.19|2.5||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.50|1.19|<0.001
70902527|NCT01216163|141293318|SUPERIORITY_OR_OTHER||LS mean difference|3.37|||<|0.001|TWO_SIDED|95.0|2.67|4.06||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.06|2.67|<0.001
70902528|NCT01216163|141293318|SUPERIORITY_OR_OTHER||LS mean difference|0.77||||0.008|TWO_SIDED|95.0|0.2|1.33||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.33|0.20|0.008
70902529|NCT01216163|141293318|SUPERIORITY_OR_OTHER||LS mean difference|2.6|||<|0.001|TWO_SIDED|95.0|1.91|3.3||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.30|1.91|<0.001
70902530|NCT01216163|141293318|SUPERIORITY_OR_OTHER||LS mean difference|3.68|||<|0.001|TWO_SIDED|95.0|2.92|4.43||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.43|2.92|<0.001
70902531|NCT01216163|141293318|SUPERIORITY_OR_OTHER||LS mean difference|0.69||||0.028|TWO_SIDED|95.0|0.07|1.3||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.30|0.07|0.028
70902532|NCT01216163|141293318|SUPERIORITY_OR_OTHER||LS mean difference|2.99|||<|0.001|TWO_SIDED|95.0|2.24|3.74||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.74|2.24|<0.001
70902533|NCT01216163|141293318|SUPERIORITY_OR_OTHER||LS mean difference|3.75|||<|0.001|TWO_SIDED|95.0|2.9|4.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.59|2.90|<0.001
70902534|NCT01216163|141293318|SUPERIORITY_OR_OTHER||LS mean difference|0.82||||0.02|TWO_SIDED|95.0|0.13|1.51||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.51|0.13|0.020
70902535|NCT01216163|141293318|SUPERIORITY_OR_OTHER||LS mean difference|2.93|||<|0.001|TWO_SIDED|95.0|2.09|3.77||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.77|2.09|<0.001
70902536|NCT01216163|141293318|SUPERIORITY_OR_OTHER||LS mean difference|3.38|||<|0.001|TWO_SIDED|95.0|2.46|4.3||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.30|2.46|<0.001
70902537|NCT01216163|141293318|SUPERIORITY_OR_OTHER||LS mean difference|1.01||||0.009|TWO_SIDED|95.0|0.26|1.76||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.76|0.26|0.009
70902538|NCT01216163|141293318|SUPERIORITY_OR_OTHER||LS mean difference|2.38|||<|0.001|TWO_SIDED|95.0|1.46|3.3||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.30|1.46|<0.001
70902539|NCT01216163|141293318|SUPERIORITY_OR_OTHER||LS mean difference|3.24|||<|0.001|TWO_SIDED|95.0|2.3|4.19||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.19|2.30|<0.001
70902540|NCT01216163|141293318|SUPERIORITY_OR_OTHER||LS mean difference|1.08||||0.006|TWO_SIDED|95.0|0.31|1.85||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.85|0.31|0.006
70902541|NCT01216163|141293318|SUPERIORITY_OR_OTHER||LS mean difference|2.16|||<|0.001|TWO_SIDED|95.0|1.22|3.1||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.10|1.22|<0.001
70902542|NCT01216163|141293318|SUPERIORITY_OR_OTHER||LS mean difference|2.47|||<|0.001|TWO_SIDED|95.0|1.51|3.43||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.43|1.51|<0.001
70902543|NCT01216163|141293318|SUPERIORITY_OR_OTHER||LS mean difference|0.7||||0.08|TWO_SIDED|95.0|-0.09|1.49||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.49|-0.09|0.080
70902544|NCT01216163|141293318|SUPERIORITY_OR_OTHER||LS mean difference|1.77|||<|0.001|TWO_SIDED|95.0|0.81|2.73||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.73|0.81|<0.001
70902545|NCT01216163|141293318|SUPERIORITY_OR_OTHER||LS mean difference|2.39|||<|0.001|TWO_SIDED|95.0|1.41|3.37||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.37|1.41|<0.001
70902546|NCT01216163|141293318|SUPERIORITY_OR_OTHER||LS mean difference|0.85||||0.037|TWO_SIDED|95.0|0.05|1.65||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.65|0.05|0.037
70902547|NCT01216163|141293318|SUPERIORITY_OR_OTHER||LS mean difference|1.54||||0.002|TWO_SIDED|95.0|0.57|2.52||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.52|0.57|0.002
70902548|NCT01216163|141293319|SUPERIORITY_OR_OTHER||LS mean difference|2.38|||<|0.001|TWO_SIDED|95.0|1.88|2.88||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.88|1.88|<0.001
70902549|NCT01216163|141293319|SUPERIORITY_OR_OTHER||LS mean difference|0.56||||0.007|TWO_SIDED|95.0|0.15|0.97||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.97|0.15|0.007
70902550|NCT01216163|141293319|SUPERIORITY_OR_OTHER||LS mean difference|1.82|||<|0.001|TWO_SIDED|95.0|1.32|2.32||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.32|1.32|<0.001
70902551|NCT01216163|141293319|SUPERIORITY_OR_OTHER||LS mean difference|3.67|||<|0.001|TWO_SIDED|95.0|2.85|4.49||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.49|2.85|<0.001
70902552|NCT01216163|141293319|SUPERIORITY_OR_OTHER||LS mean difference|0.98||||0.004|TWO_SIDED|95.0|0.31|1.66||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.66|0.31|0.004
70902553|NCT01216163|141293319|SUPERIORITY_OR_OTHER||LS mean difference|2.69|||<|0.001|TWO_SIDED|95.0|1.87|3.51||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.51|1.87|<0.001
70902554|NCT01216163|141293319|SUPERIORITY_OR_OTHER||LS mean difference|6.8|||<|0.001|TWO_SIDED|95.0|4.96|8.64||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-6: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||8.64|4.96|<0.001
70902555|NCT01216163|141293319|SUPERIORITY_OR_OTHER||LS mean difference|2.09||||0.007|TWO_SIDED|95.0|0.59|3.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-6: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.59|0.59|0.007
70902556|NCT01216163|141293319|SUPERIORITY_OR_OTHER||LS mean difference|4.71|||<|0.001|TWO_SIDED|95.0|2.87|6.54||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-6: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||6.54|2.87|<0.001
70902557|NCT01216163|141293320|SUPERIORITY_OR_OTHER||LS mean difference|3.81|||<|0.001|TWO_SIDED|95.0|3.05|4.57||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.57|3.05|<0.001
70902558|NCT01216163|141293320|SUPERIORITY_OR_OTHER||LS mean difference|0.76||||0.016|TWO_SIDED|95.0|0.14|1.38||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.38|0.14|0.016
70902559|NCT01216163|141293320|SUPERIORITY_OR_OTHER||LS mean difference|3.04|||<|0.001|TWO_SIDED|95.0|2.29|3.8||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.80|2.29|<0.001
70902560|NCT01216163|141293320|SUPERIORITY_OR_OTHER||LS mean difference|5.9|||<|0.001|TWO_SIDED|95.0|4.66|7.15||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||7.15|4.66|<0.001
70902561|NCT01216163|141293320|SUPERIORITY_OR_OTHER||LS mean difference|1.35||||0.01|TWO_SIDED|95.0|0.33|2.37||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.37|0.33|0.010
70902562|NCT01216163|141293320|SUPERIORITY_OR_OTHER||LS mean difference|4.56|||<|0.001|TWO_SIDED|95.0|3.31|5.8||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||5.80|3.31|<0.001
70902563|NCT01216163|141293320|SUPERIORITY_OR_OTHER||LS mean difference|10.88|||<|0.001|TWO_SIDED|95.0|8.05|13.7||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-6: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||13.70|8.05|<0.001
70902564|NCT01216163|141293320|SUPERIORITY_OR_OTHER||LS mean difference|2.87||||0.015|TWO_SIDED|95.0|0.57|5.18||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-6: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||5.18|0.57|0.015
70902565|NCT01216163|141293320|SUPERIORITY_OR_OTHER||LS mean difference|8.0|||<|0.001|TWO_SIDED|95.0|5.18|10.83||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-6: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||10.83|5.18|<0.001
70902566|NCT01216163|141293321|SUPERIORITY_OR_OTHER||LS mean difference|6.19|||<|0.001|TWO_SIDED|95.0|4.96|7.43||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||7.43|4.96|<0.001
70902567|NCT01216163|141293321|SUPERIORITY_OR_OTHER||LS mean difference|1.33||||0.01|TWO_SIDED|95.0|0.32|2.33||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.33|0.32|0.010
70902568|NCT01216163|141293321|SUPERIORITY_OR_OTHER||LS mean difference|4.87|||<|0.001|TWO_SIDED|95.0|3.63|6.1||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||6.10|3.63|<0.001
70902569|NCT01216163|141293321|SUPERIORITY_OR_OTHER||LS mean difference|9.58|||<|0.001|TWO_SIDED|95.0|7.54|11.61||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||11.61|7.54|<0.001
70902570|NCT01216163|141293321|SUPERIORITY_OR_OTHER||LS mean difference|2.33||||0.006|TWO_SIDED|95.0|0.67|4.0||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.00|0.67|0.006
70902571|NCT01216163|141293321|SUPERIORITY_OR_OTHER||LS mean difference|7.24|||<|0.001|TWO_SIDED|95.0|5.21|9.28||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||9.28|5.21|<0.001
70902572|NCT01216163|141293322|SUPERIORITY_OR_OTHER||Difference in proportion|21.42|||<|0.001|TWO_SIDED|95.0|12.99|29.84||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions and the corresponding standard error.||29.84|12.99|<0.001
70902573|NCT01216163|141293322|SUPERIORITY_OR_OTHER||Difference in proportion|1.58||||0.799|TWO_SIDED|95.0|-10.54|13.7||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.70|-10.54|0.799
70902574|NCT01216163|141293322|SUPERIORITY_OR_OTHER||Difference in proportion|20.09||||0.001|TWO_SIDED|95.0|11.45|28.72||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||28.72|11.45|0.001
70902575|NCT01216163|141293322|SUPERIORITY_OR_OTHER||Difference in proportion|53.22|||<|0.001|TWO_SIDED|95.0|42.92|63.53||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||63.53|42.92|<0.001
70902576|NCT01216163|141293322|SUPERIORITY_OR_OTHER||Difference in proportion|-2.98||||0.695|TWO_SIDED|95.0|-17.67|11.7||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.70|-17.67|0.695
70902577|NCT01216163|141293322|SUPERIORITY_OR_OTHER||Difference in proportion|57.06|||<|0.001|TWO_SIDED|95.0|46.53|67.6||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||67.60|46.53|<0.001
70902578|NCT01216163|141293322|SUPERIORITY_OR_OTHER||Difference in proportion|70.58|||<|0.001|TWO_SIDED|95.0|60.28|80.88||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||80.88|60.28|<0.001
70902579|NCT01216163|141293322|SUPERIORITY_OR_OTHER||Difference in proportion|7.99||||0.261|TWO_SIDED|95.0|-5.85|21.84||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||21.84|-5.85|0.261
70902580|NCT01216163|141293322|SUPERIORITY_OR_OTHER||Difference in proportion|62.88|||<|0.001|TWO_SIDED|95.0|51.78|73.99||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||73.99|51.78|<0.001
70902581|NCT01216163|141293322|SUPERIORITY_OR_OTHER||Difference in proportion|66.24|||<|0.001|TWO_SIDED|95.0|53.77|78.71||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||78.71|53.77|<0.001
70902582|NCT01216163|141293322|SUPERIORITY_OR_OTHER||Difference in proportion|4.38||||0.522|TWO_SIDED|95.0|-8.89|17.64||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.64|-8.89|0.522
70902583|NCT01216163|141293322|SUPERIORITY_OR_OTHER||Difference in proportion|61.93|||<|0.001|TWO_SIDED|95.0|49.06|74.8||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.80|49.06|<0.001
70902584|NCT01216163|141293322|SUPERIORITY_OR_OTHER||Difference in proportion|66.35|||<|0.001|TWO_SIDED|95.0|53.61|79.09||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.09|53.61|<0.001
70902585|NCT01216163|141293322|SUPERIORITY_OR_OTHER||Difference in proportion|5.46||||0.415|TWO_SIDED|95.0|-7.53|18.44||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.44|-7.53|0.415
70902586|NCT01216163|141293322|SUPERIORITY_OR_OTHER||Difference in proportion|60.92|||<|0.001|TWO_SIDED|95.0|47.65|74.19||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.19|47.65|<0.001
70902587|NCT01216163|141293322|SUPERIORITY_OR_OTHER||Difference in proportion|65.32|||<|0.001|TWO_SIDED|95.0|52.18|78.46||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||78.46|52.18|<0.001
70902588|NCT01216163|141293322|SUPERIORITY_OR_OTHER||Difference in proportion|4.21||||0.519|TWO_SIDED|95.0|-8.39|16.81||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||16.81|-8.39|0.519
70902589|NCT01216163|141293322|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
70902590|NCT01216163|141293322|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
70902591|NCT01216163|141293322|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
70902592|NCT01216163|141293322|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
70902593|NCT01216163|141293322|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
70902594|NCT01216163|141293322|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
70902595|NCT01216163|141293322|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
70902596|NCT01216163|141293323|SUPERIORITY_OR_OTHER||Difference in proportion|26.4|||<|0.001|TWO_SIDED|95.0|15.87|36.93||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||36.93|15.87|<0.001
70902597|NCT01216163|141293323|SUPERIORITY_OR_OTHER||Difference in proportion|3.53||||0.602|TWO_SIDED|95.0|-9.85|16.91||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||16.91|-9.85|0.602
70902598|NCT01216163|141293323|SUPERIORITY_OR_OTHER||Difference in proportion|22.72||||0.001|TWO_SIDED|95.0|12.39|33.05||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||33.05|12.39|0.001
70902599|NCT01216163|141293323|SUPERIORITY_OR_OTHER||Difference in proportion|60.37|||<|0.001|TWO_SIDED|95.0|48.61|72.12||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||72.12|48.61|<0.001
70902600|NCT01216163|141293323|SUPERIORITY_OR_OTHER||Difference in proportion|2.25||||0.761|TWO_SIDED|95.0|-12.1|16.59||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||16.59|-12.10|0.761
70902601|NCT01216163|141293323|SUPERIORITY_OR_OTHER||Difference in proportion|58.32|||<|0.001|TWO_SIDED|95.0|46.59|70.05||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||70.05|46.59|<0.001
70902602|NCT01216163|141293323|SUPERIORITY_OR_OTHER||Difference in proportion|67.52|||<|0.001|TWO_SIDED|95.0|54.91|80.12||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||80.12|54.91|<0.001
70902603|NCT01216163|141293323|SUPERIORITY_OR_OTHER||Difference in proportion|5.42||||0.41|TWO_SIDED|95.0|-7.34|18.18||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.18|-7.34|0.410
70902604|NCT01216163|141293323|SUPERIORITY_OR_OTHER||Difference in proportion|62.13|||<|0.001|TWO_SIDED|95.0|48.96|75.29||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||75.29|48.96|<0.001
70902605|NCT01216163|141293323|SUPERIORITY_OR_OTHER||Difference in proportion|68.64|||<|0.001|TWO_SIDED|95.0|56.11|81.16||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.16|56.11|<0.001
70902606|NCT01216163|141293323|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
70902607|NCT01216163|141293323|SUPERIORITY_OR_OTHER||Difference in proportion|63.34|||<|0.001|TWO_SIDED|95.0|50.32|76.35||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||76.35|50.32|<0.001
70902608|NCT01216163|141293323|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
70902609|NCT01216163|141293323|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
70902610|NCT01216163|141293323|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
70902611|NCT01216163|141293323|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
70902612|NCT01216163|141293323|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
70902613|NCT01216163|141293323|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
70902614|NCT01216163|141293323|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
70902615|NCT01216163|141293323|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
70902616|NCT01216163|141293323|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
70902617|NCT01216163|141293323|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
70902618|NCT01216163|141293323|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
70902619|NCT01216163|141293323|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
70902620|NCT01216163|141293323|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
70902621|NCT01216163|141293323|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
70902622|NCT01216163|141293323|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
70902623|NCT01216163|141293324|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.22||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||0.22|0.08|<0.001
70902624|NCT01216163|141293324|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.303|TWO_SIDED|95.0|0.45|1.28||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.28|0.45|0.303
70902625|NCT01216163|141293324|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.17|||<|0.001|TWO_SIDED|95.0|0.1|0.28||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||0.28|0.10|<0.001
70902626|NCT01216163|141293325|SUPERIORITY_OR_OTHER||Difference in proportion|-40.1|||<|0.001|TWO_SIDED|95.0|-55.39|-24.8||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-24.80|-55.39|<0.001
70902627|NCT01216163|141293325|SUPERIORITY_OR_OTHER||Difference in proportion|-0.12||||0.958|TWO_SIDED|95.0|-4.52|4.28||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.28|-4.52|0.958
70902628|NCT01216163|141293325|SUPERIORITY_OR_OTHER||Difference in proportion|-40.19|||<|0.001|TWO_SIDED|95.0|-55.51|-24.87||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-24.87|-55.51|<0.001
70902629|NCT01216163|141293325|SUPERIORITY_OR_OTHER||Difference in proportion|-63.4|||<|0.001|TWO_SIDED|95.0|-77.81|-48.99||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-48.99|-77.81|<0.001
70902630|NCT01216163|141293325|SUPERIORITY_OR_OTHER||Difference in proportion|-7.17||||0.108|TWO_SIDED|95.0|-15.91|1.57||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.57|-15.91|0.108
70902631|NCT01216163|141293325|SUPERIORITY_OR_OTHER||Difference in proportion|-56.39|||<|0.001|TWO_SIDED|95.0|-71.68|-41.09||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-41.09|-71.68|<0.001
70902632|NCT01216163|141293325|SUPERIORITY_OR_OTHER||Difference in proportion|-71.01|||<|0.001|TWO_SIDED|95.0|-84.09|-57.93||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-57.93|-84.09|<0.001
70902633|NCT01216163|141293325|SUPERIORITY_OR_OTHER||Difference in proportion|-9.82||||0.083|TWO_SIDED|95.0|-20.18|1.16||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.16|-20.18|0.083
70902634|NCT01216163|141293325|SUPERIORITY_OR_OTHER||Difference in proportion|-61.14|||<|0.001|TWO_SIDED|95.0|-75.4|-46.87||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-46.87|-75.40|<0.001
70902635|NCT01216163|141293325|SUPERIORITY_OR_OTHER||Difference in proportion|-66.37|||<|0.001|TWO_SIDED|95.0|-80.08|-52.66||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-52.66|-80.08|<0.001
70902636|NCT01216163|141293325|SUPERIORITY_OR_OTHER||Difference in proportion|-11.03||||0.079|TWO_SIDED|95.0|-23.37|1.21||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.21|-23.37|0.079
70902637|NCT01216163|141293325|SUPERIORITY_OR_OTHER||Difference in proportion|-55.53|||<|0.001|TWO_SIDED|95.0|-70.12|-40.85||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-40.85|-70.12|<0.001
70902638|NCT01216163|141293325|SUPERIORITY_OR_OTHER||Difference in proportion|-57.33|||<|0.001|TWO_SIDED|95.0|-71.9|-42.77||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-42.77|-71.90|<0.001
70902639|NCT01216163|141293325|SUPERIORITY_OR_OTHER||Difference in proportion|-7.73||||0.263|TWO_SIDED|95.0|-21.08|5.63||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||5.63|-21.08|0.263
70902640|NCT01216163|141293325|SUPERIORITY_OR_OTHER||Difference in proportion|-49.93|||<|0.001|TWO_SIDED|95.0|-64.74|-35.12||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-35.12|-64.74|<0.001
70902641|NCT01216163|141293325|SUPERIORITY_OR_OTHER||Difference in proportion|-52.75|||<|0.001|TWO_SIDED|95.0|-67.62|-37.88||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-37.88|-67.62|<0.001
70902642|NCT01216163|141293325|SUPERIORITY_OR_OTHER||Difference in proportion|-5.51||||0.439|TWO_SIDED|95.0|-19.27|8.25||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.25|-19.27|0.439
70902643|NCT01216163|141293325|SUPERIORITY_OR_OTHER||Difference in proportion|-47.72|||<|0.001|TWO_SIDED|95.0|-62.62|-32.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-32.83|-62.62|<0.001
70902644|NCT01216163|141293326|SUPERIORITY_OR_OTHER||Difference in proportion|-1.21||||0.294|TWO_SIDED|95.0|-3.59|1.17||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.17|-3.59|0.294
70902645|NCT01216163|141293326|SUPERIORITY_OR_OTHER||Difference in proportion|1.21||||0.458|TWO_SIDED|95.0|-1.16|3.58||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.58|-1.16|0.458
70902646|NCT01216163|141293326|SUPERIORITY_OR_OTHER||Difference in proportion|6.81||||0.073|TWO_SIDED|95.0|1.57|12.06||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.06|1.57|0.073
70902647|NCT01216163|141293326|SUPERIORITY_OR_OTHER||Difference in proportion|1.96||||0.583|TWO_SIDED|95.0|-4.94|8.85||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.85|-4.94|0.583
70902648|NCT01216163|141293326|SUPERIORITY_OR_OTHER||Difference in proportion|4.81||||0.137|TWO_SIDED|95.0|0.14|9.49||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.49|0.14|0.137
70902649|NCT01216163|141293326|SUPERIORITY_OR_OTHER||Difference in proportion|23.86|||<|0.001|TWO_SIDED|95.0|14.81|32.91||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||32.91|14.81|<0.001
70902650|NCT01216163|141293326|SUPERIORITY_OR_OTHER||Difference in proportion|8.45||||0.165|TWO_SIDED|95.0|-3.43|20.33||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.33|-3.43|0.165
70902651|NCT01216163|141293326|SUPERIORITY_OR_OTHER||Difference in proportion|15.46||||0.006|TWO_SIDED|95.0|7.66|23.26||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||23.26|7.66|0.006
70902652|NCT01216163|141293326|SUPERIORITY_OR_OTHER||Difference in proportion|29.41|||<|0.001|TWO_SIDED|95.0|19.78|39.05||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||39.05|19.78|<0.001
70902653|NCT01216163|141293326|SUPERIORITY_OR_OTHER||Difference in proportion|4.61||||0.497|TWO_SIDED|95.0|-8.78|17.99||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.99|-8.78|0.497
70902654|NCT01216163|141293326|SUPERIORITY_OR_OTHER||Difference in proportion|25.13|||<|0.001|TWO_SIDED|95.0|15.81|34.46||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||34.46|15.81|<0.001
70902655|NCT01216163|141293326|SUPERIORITY_OR_OTHER||Difference in proportion|31.78|||<|0.001|TWO_SIDED|95.0|20.03|43.53||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||43.53|20.03|<0.001
70902656|NCT01216163|141293326|SUPERIORITY_OR_OTHER||Difference in proportion|6.7||||0.349|TWO_SIDED|95.0|-7.38|20.79||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.79|-7.38|0.349
70902657|NCT01216163|141293326|SUPERIORITY_OR_OTHER||Difference in proportion|25.34|||<|0.001|TWO_SIDED|95.0|13.73|36.94||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||36.94|13.73|<0.001
70902658|NCT01216163|141293326|SUPERIORITY_OR_OTHER||Difference in proportion|37.64|||<|0.001|TWO_SIDED|95.0|25.47|49.81||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||49.81|25.47|<0.001
70902659|NCT01216163|141293326|SUPERIORITY_OR_OTHER||Difference in proportion|8.85||||0.233|TWO_SIDED|95.0|-5.72|23.42||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||23.42|-5.72|0.233
70902660|NCT01216163|141293326|SUPERIORITY_OR_OTHER||Difference in proportion|28.96|||<|0.001|TWO_SIDED|95.0|17.17|40.75||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||40.75|17.17|<0.001
70902661|NCT01216163|141293326|SUPERIORITY_OR_OTHER||Difference in proportion|38.73|||<|0.001|TWO_SIDED|95.0|25.87|51.6||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||51.60|25.87|<0.001
70902662|NCT01216163|141293326|SUPERIORITY_OR_OTHER||Difference in proportion|9.83||||0.189|TWO_SIDED|95.0|-4.8|24.45||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||24.45|-4.80|0.189
70902663|NCT01216163|141293326|SUPERIORITY_OR_OTHER||Difference in proportion|29.19|||<|0.001|TWO_SIDED|95.0|16.71|41.66||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||41.66|16.71|<0.001
70902664|NCT01216163|141293326|SUPERIORITY_OR_OTHER||Difference in proportion|36.55|||<|0.001|TWO_SIDED|95.0|23.22|49.88||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||49.88|23.22|<0.001
70902665|NCT01216163|141293326|SUPERIORITY_OR_OTHER||Difference in proportion|9.83||||0.189|TWO_SIDED|95.0|-4.8|24.45||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||24.45|-4.80|0.189
70902666|NCT01216163|141293326|SUPERIORITY_OR_OTHER||Difference in proportion|26.97|||<|0.001|TWO_SIDED|95.0|14.0|39.94||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||39.94|14.00|<0.001
70902667|NCT01216163|141293326|SUPERIORITY_OR_OTHER||Difference in proportion|37.72|||<|0.001|TWO_SIDED|95.0|24.36|51.07||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||51.07|24.36|<0.001
70902668|NCT01216163|141293326|SUPERIORITY_OR_OTHER||Difference in proportion|10.97||||0.144|TWO_SIDED|95.0|-3.67|25.61||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||25.61|-3.67|0.144
70902669|NCT01216163|141293326|SUPERIORITY_OR_OTHER||Difference in proportion|26.97|||<|0.001|TWO_SIDED|95.0|14.0|39.94||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||39.94|14.00|<0.001
70902670|NCT01216163|141293327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.87|||<|0.001|TWO_SIDED|95.0|0.78|0.96||P-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Ibuprofen sodium - Placebo) and the associated CI were calculated based on the weighted Gamma statistic.||0.96|0.78|<0.001
70902671|NCT01216163|141293327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.02|TWO_SIDED|95.0|0.05|0.45||P-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Ibuprofen sodium - Acetaminophen) and the associated CI were calculated based on the weighted Gamma statistic.||0.45|0.05|0.020
70902672|NCT01216163|141293327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|||<|0.001|TWO_SIDED|95.0|0.63|0.91||P-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Acetaminophen - Placebo) and the associated CI were calculated based on the weighted Gamma statistic.||0.91|0.63|<0.001
70902673|NCT05807919|141293339|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
70902674|NCT05807919|141293340|SUPERIORITY|||||||0.39|||||||Fisher Exact|||||||0.39
70902675|NCT05807919|141293341|SUPERIORITY|||||||0.18|||||||Fisher Exact|||||||0.18
70902676|NCT05807919|141293342|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
70902677|NCT05807919|141293343|SUPERIORITY|||||||0.39|||||||Fisher Exact|||||||0.39
70902678|NCT05807919|141293344|SUPERIORITY|||||||0.48|||||||Fisher Exact|||||||0.48
70902679|NCT01557322|141293345|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Chi-squared|||Morning Stiffness \> 1 Hour: p-value was calculated using chi-square test.||||0.010
70902680|NCT01557322|141293345|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Arthritis or Deformity of 3 or More Joint Areas: p-value was calculated using chi-square test.||||<0.001
70902681|NCT01557322|141293345|SUPERIORITY_OR_OTHER|||||||0.363|TWO_SIDED||||||Chi-squared|||Arthritis/Deformity of Hand/Joint: p-value was calculated using chi-square test.||||0.363
70902682|NCT01557322|141293345|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Symmetry: p-value was calculated using chi-square test.||||<0.001
70902683|NCT01557322|141293345|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Nodules: p-value was calculated using chi-square test.||||<0.001
70902684|NCT01557322|141293345|SUPERIORITY_OR_OTHER|||||||0.605|TWO_SIDED||||||Chi-squared|||Rheumatoid Factor Positive: p-value was calculated using chi-square test.||||0.605
70902685|NCT01557322|141293345|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||Chi-squared|||Erosions on Hand or Feet X-Ray: p-value was calculated using chi-square test.||||0.038
70902686|NCT01557322|141293346|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Sicca Syndrome: p-value was calculated using chi-square test.||||<0.001
70902687|NCT01557322|141293346|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED||||||Chi-squared|||Serosal Involvement: p-value was calculated using chi-square test.||||0.024
70902688|NCT01557322|141293346|SUPERIORITY_OR_OTHER|||||||0.257|TWO_SIDED||||||Chi-squared|||Eye Involvement: p-value was calculated using chi-square test.||||0.257
70902689|NCT01557322|141293346|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED||||||Chi-squared|||Systemic Vasculitis: p-value was calculated using chi-square test.||||0.026
70902690|NCT01557322|141293346|SUPERIORITY_OR_OTHER|||||||0.725|TWO_SIDED||||||Chi-squared|||Nailfold Vasculitis: p-value was calculated using chi-square test.||||0.725
70902691|NCT01557322|141293346|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Chi-squared|||Pulmonary Fibrosis: p-value was calculated using chi-square test.||||0.220
70902692|NCT01557322|141293346|SUPERIORITY_OR_OTHER|||||||0.62|TWO_SIDED||||||Chi-squared|||Other: p-value was calculated using chi-square test.||||0.620
70902693|NCT01557322|141293347|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Total Knee Replacement: p-value was calculated using chi-square test.||||<0.001
70902694|NCT01557322|141293347|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Total Hip Replacement: p-value was calculated using chi-square test.||||<0.001
70902695|NCT01557322|141293347|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Total Shoulder Replacement: p-value was calculated using chi-square test.||||<0.001
70902696|NCT01557322|141293347|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Total Elbow Replacement: p-value was calculated using chi-square test.||||<0.001
70902697|NCT01557322|141293347|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Chi-squared|||Wrist/Hand/Ankle/Foot Surgery: p-value was calculated using chi-square test.||||0.001
70902698|NCT01557322|141293347|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Neck Surgery: p-value was calculated using chi-square test.||||<0.001
70902699|NCT01557322|141293348|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||P-value was calculated using chi-square test.||||<0.001
70902700|NCT01557322|141293349|SUPERIORITY_OR_OTHER|||||||0.381|TWO_SIDED||||||Chi-squared|||High Blood Pressure: p-value was calculated using chi-square test.||||0.381
70902701|NCT01557322|141293349|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Chi-squared|||Angina: p-value was calculated using chi-square test.||||0.006
70902702|NCT01557322|141293349|SUPERIORITY_OR_OTHER|||||||0.215|TWO_SIDED||||||Chi-squared|||Heart Attack: p-value was calculated using chi-square test.||||0.215
70902703|NCT01557322|141293349|SUPERIORITY_OR_OTHER|||||||0.117|TWO_SIDED||||||Chi-squared|||Stroke: p-value was calculated using chi-square test.||||0.117
70902704|NCT01557322|141293349|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Epilepsy: p-value was calculated using chi-square test.||||1.000
70902705|NCT01557322|141293349|SUPERIORITY_OR_OTHER|||||||0.542|TWO_SIDED||||||Chi-squared|||Asthma: p-value was calculated using chi-square test.||||0.542
70902706|NCT01557322|141293349|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED||||||Chi-squared|||Chronic Bronchitis/Emphysema: p-value was calculated using chi-square test.||||0.027
70902707|NCT01557322|141293349|SUPERIORITY_OR_OTHER|||||||0.566|TWO_SIDED||||||Chi-squared|||Peptic Ulcer: p-value was calculated using chi-square test.||||0.566
70902708|NCT01557322|141293349|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Chi-squared|||Liver Disease: p-value was calculated using chi-square test.||||0.003
70902709|NCT01557322|141293349|SUPERIORITY_OR_OTHER|||||||0.526|TWO_SIDED||||||Chi-squared|||Renal Disease: p-value was calculated using chi-square test.||||0.526
70902710|NCT01557322|141293349|SUPERIORITY_OR_OTHER|||||||0.802|TWO_SIDED||||||Chi-squared|||Tuberculosis: p-value was calculated using chi-square test.||||0.802
70902711|NCT01557322|141293349|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Demyelination: p-value was calculated using chi-square test.||||1.000
70902712|NCT01557322|141293349|SUPERIORITY_OR_OTHER|||||||0.385|TWO_SIDED||||||Chi-squared|||Diabetes: p-value was calculated using chi-square test.||||0.385
70902713|NCT01557322|141293349|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||Chi-squared|||Hyperthyroidism: p-value was calculated using chi-square test.||||0.048
70902714|NCT01557322|141293349|SUPERIORITY_OR_OTHER|||||||0.308|TWO_SIDED||||||Chi-squared|||Depression: p-value was calculated using chi-square test.||||0.308
70902715|NCT01557322|141293349|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||Chi-squared|||Cancer: p-value was calculated using chi-square test.||||0.033
70902716|NCT01557322|141293350|SUPERIORITY_OR_OTHER|||||||0.188|TWO_SIDED||||||t-test, 2 sided|||P-value was calculated using 2-sided t-test.||||0.188
70902717|NCT01557322|141293351|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||t-test, 2 sided|||Systolic Blood Pressure: p-value was calculated using 2-sided t-test.||||0.016
70902718|NCT01557322|141293351|SUPERIORITY_OR_OTHER|||||||0.369|TWO_SIDED||||||t-test, 2 sided|||Diastolic Blood Pressure: p-value was calculated using 2-sided t-test.||||0.369
70902719|NCT01557322|141293352|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||<0.001
70902720|NCT01557322|141293352|SUPERIORITY_OR_OTHER|||||||0.3746|TWO_SIDED||||||Regression, Linear|||Change at Month 60: p-value was calculated using multivariate linear regression with baseline DAS28 score and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.||||0.3746
70902721|NCT01557322|141293353|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||<0.001
70902722|NCT01557322|141293354|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||<0.001
70902723|NCT01557322|141293355|SUPERIORITY_OR_OTHER|||||||0.154|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||0.154
70902724|NCT01557322|141293356|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||0.108
70902725|NCT01557322|141293357|SUPERIORITY_OR_OTHER|||||||0.199|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||0.199
70902726|NCT01557322|141293358|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||P-value was calculated using 2-sided t-test.||||<0.001
70902727|NCT01557322|141293359|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||P-value was calculated using 2-sided t-test.||||<0.001
70902728|NCT01557322|141293361|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Current DMARDs, Methotrexate: p-value was calculated using chi-square test.||||<0.001
70902729|NCT01557322|141293361|SUPERIORITY_OR_OTHER|||||||0.313|TWO_SIDED||||||Chi-squared|||Current DMARDs, Azathioprine: p-value was calculated using chi-square test.||||0.313
70902730|NCT01557322|141293361|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Current DMARDs, Cyclophosphamide: p-value was calculated using chi-square test.||||1.000
70902731|NCT01557322|141293361|SUPERIORITY_OR_OTHER|||||||0.066|TWO_SIDED||||||Chi-squared|||Current DMARDs, Cyclosporine: p-value was calculated using chi-square test.||||0.066
70902732|NCT01557322|141293361|SUPERIORITY_OR_OTHER|||||||0.099|TWO_SIDED||||||Chi-squared|||Current DMARDs, Leflunomide: p-value was calculated using chi-square test.||||0.099
70902733|NCT01557322|141293361|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Current DMARDs, Sulphasalazine: p-value was calculated using chi-square test.||||<0.001
70902734|NCT01557322|141293361|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Previous DMARDs, Methotrexate: p-value was calculated using chi-square test.||||<0.001
70902735|NCT01557322|141293361|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Previous DMARDs, Azathioprine: p-value was calculated using chi-square test.||||<0.001
70902736|NCT01557322|141293361|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Previous DMARDs, Cyclophosphamide: p-value was calculated using chi-square test.||||<0.001
70902737|NCT01557322|141293361|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Previous DMARDs, Cyclosporine: p-value was calculated using chi-square test.||||<0.001
70902738|NCT01557322|141293361|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Previous DMARDs, Leflunomide: p-value was calculated using chi-square test.||||<0.001
70902739|NCT01557322|141293362|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||<0.001
70902740|NCT01557322|141293363|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Baseline PCS: p-value was calculated using 2-sided t-test.||||<0.001
70902741|NCT01557322|141293363|SUPERIORITY_OR_OTHER|||||||0.886|TWO_SIDED||||||t-test, 2 sided|||Baseline MCS: p-value was calculated using 2-sided t-test.||||0.886
70902742|NCT01557322|141293363|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||t-test, 2 sided|||Baseline Vitality Score: p-value was calculated using 2-sided t-test.||||0.680
70902743|NCT01557322|141293373|SUPERIORITY_OR_OTHER|||||||0.0233|TWO_SIDED||||||Chi-squared|||Month 6: p-value was calculated using chi-square test.||||0.0233
70902744|NCT01557322|141293373|SUPERIORITY_OR_OTHER|||||||0.5103|TWO_SIDED||||||Chi-squared|||Month 12: p-value was calculated using chi-square test.||||0.5103
70902745|NCT01557322|141293373|SUPERIORITY_OR_OTHER|||||||0.999|TWO_SIDED||||||Chi-squared|||Month 18: p-value was calculated using chi-square test.||||0.9990
70902746|NCT01557322|141293373|SUPERIORITY_OR_OTHER|||||||0.6495|TWO_SIDED||||||Chi-squared|||Month 24: p-value was calculated using chi-square test.||||0.6495
70902747|NCT01557322|141293373|SUPERIORITY_OR_OTHER|||||||0.3829|TWO_SIDED||||||Chi-squared|||Month 30: p-value was calculated using chi-square test.||||0.3829
70902748|NCT01557322|141293373|SUPERIORITY_OR_OTHER|||||||0.1085|TWO_SIDED||||||Chi-squared|||Month 36: p-value was calculated using chi-square test.||||0.1085
70902749|NCT01557322|141293373|SUPERIORITY_OR_OTHER|||||||0.0472|TWO_SIDED||||||Chi-squared|||Month 48: p-value was calculated using chi-square test.||||0.0472
70902750|NCT01557322|141293373|SUPERIORITY_OR_OTHER|||||||0.4804|TWO_SIDED||||||Chi-squared|||Month 60: p-value was calculated using chi-square test.||||0.4804
70902751|NCT01557322|141293374|SUPERIORITY_OR_OTHER|||||||0.0895|TWO_SIDED||||||Chi-squared|||Lymphoproliferative Tumors, Month 6: p-value was calculated using chi-square test.||||0.0895
70902752|NCT01557322|141293374|SUPERIORITY_OR_OTHER|||||||0.0774|TWO_SIDED||||||Chi-squared|||Lymphoproliferative Tumors, Month 12: p-value was calculated using chi-square test.||||0.0774
70902753|NCT01557322|141293374|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||Chi-squared|||Lymphoproliferative Tumors, Month 18: p-value was calculated using chi-square test.||||0.0024
70902754|NCT01557322|141293374|SUPERIORITY_OR_OTHER|||||||0.5552|TWO_SIDED||||||Chi-squared|||Lymphoproliferative Tumors, Month 30: p-value was calculated using chi-square test.||||0.5552
70902755|NCT01557322|141293374|SUPERIORITY_OR_OTHER|||||||0.0793|TWO_SIDED||||||Chi-squared|||Lymphoproliferative Tumors, Month 36: p-value was calculated using chi-square test.||||0.0793
70902756|NCT01557322|141293374|SUPERIORITY_OR_OTHER|||||||0.0075|TWO_SIDED||||||Chi-squared|||Lymphoproliferative Tumors, Month 48: p-value was calculated using chi-square test.||||0.0075
70902757|NCT01557322|141293374|SUPERIORITY_OR_OTHER|||||||0.0895|TWO_SIDED||||||Chi-squared|||Hodgkins Lymphoma, Month 6: p-value was calculated using chi-square test.||||0.0895
70902758|NCT01557322|141293374|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||Chi-squared|||Hodgkins Lymphoma, Month 18: p-value was calculated using chi-square test.||||0.0024
70902759|NCT01557322|141293374|SUPERIORITY_OR_OTHER|||||||0.6301|TWO_SIDED||||||Chi-squared|||Hodgkins Lymphoma, Month 30: p-value was calculated using chi-square test.||||0.6301
70902760|NCT01557322|141293374|SUPERIORITY_OR_OTHER|||||||0.0793|TWO_SIDED||||||Chi-squared|||Hodgkins Lymphoma, Month 36: p-value was calculated using chi-square test.||||0.0793
70902761|NCT01557322|141293374|SUPERIORITY_OR_OTHER|||||||0.0075|TWO_SIDED||||||Chi-squared|||Hodgkins Lymphoma, Month 48: p-value was calculated using chi-square test.||||0.0075
70902762|NCT01557322|141293374|SUPERIORITY_OR_OTHER|||||||0.7253|TWO_SIDED||||||Chi-squared|||Myeloma, Month 12: p-value was calculated using chi-square test.||||0.7253
70902763|NCT01557322|141293374|SUPERIORITY_OR_OTHER|||||||0.7336|TWO_SIDED||||||Chi-squared|||Myeloma, Month 30: p-value was calculated using chi-square test.||||0.7336
70902764|NCT01557322|141293374|SUPERIORITY_OR_OTHER|||||||0.0044|TWO_SIDED||||||Chi-squared|||Leukaemia, Month 12: p-value was calculated using chi-square test.||||0.0044
70902765|NCT01557322|141293374|SUPERIORITY_OR_OTHER|||||||0.4175|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 6: p-value was calculated using chi-square test.||||0.4175
70902766|NCT01557322|141293374|SUPERIORITY_OR_OTHER|||||||0.3886|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 12: p-value was calculated using chi-square test.||||0.3886
70902767|NCT01557322|141293374|SUPERIORITY_OR_OTHER|||||||0.5102|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 18: p-value was calculated using chi-square test.||||0.5102
70902768|NCT01557322|141293374|SUPERIORITY_OR_OTHER|||||||0.9855|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 24: p-value was calculated using chi-square test.||||0.9855
70902769|NCT01557322|141293374|SUPERIORITY_OR_OTHER|||||||0.4955|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 30: p-value was calculated using chi-square test.||||0.4955
70902770|NCT01557322|141293374|SUPERIORITY_OR_OTHER|||||||0.5404|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 36: p-value was calculated using chi-square test.||||0.5404
70902771|NCT01557322|141293374|SUPERIORITY_OR_OTHER|||||||0.3581|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 48: p-value was calculated using chi-square test.||||0.3581
70902772|NCT01557322|141293374|SUPERIORITY_OR_OTHER|||||||0.4932|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 6: p-value was calculated using chi-square test.||||0.4932
70902773|NCT01557322|141293374|SUPERIORITY_OR_OTHER|||||||0.4818|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 12: p-value was calculated using chi-square test.||||0.4818
70902774|NCT01557322|141293374|SUPERIORITY_OR_OTHER|||||||0.3224|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 18: p-value was calculated using chi-square test.||||0.3224
70902775|NCT01557322|141293374|SUPERIORITY_OR_OTHER|||||||0.5003|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 24: p-value was calculated using chi-square test.||||0.5003
70902776|NCT01557322|141293374|SUPERIORITY_OR_OTHER|||||||0.1134|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 30: p-value was calculated using chi-square test.||||0.1134
70902777|NCT01557322|141293374|SUPERIORITY_OR_OTHER|||||||0.3488|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 36: p-value was calculated using chi-square test.||||0.3488
70902778|NCT01557322|141293374|SUPERIORITY_OR_OTHER|||||||0.187|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 48: p-value was calculated using chi-square test.||||0.1870
70902779|NCT01557322|141293374|SUPERIORITY_OR_OTHER|||||||0.427|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 60: p-value was calculated using chi-square test.||||0.4270
70902780|NCT01557322|141293375|SUPERIORITY_OR_OTHER|||||||0.5817|TWO_SIDED||||||Chi-squared|||Death Due to AE, Month 6: p-value was calculated using chi-square test.||||0.5817
70902781|NCT01557322|141293375|SUPERIORITY_OR_OTHER|||||||0.2595|TWO_SIDED||||||Chi-squared|||Death Due to AE, Month 12: p-value was calculated using chi-square test.||||0.2595
70902782|NCT01557322|141293375|SUPERIORITY_OR_OTHER|||||||0.5642|TWO_SIDED||||||Chi-squared|||Death Due to AE, Month 18: p-value was calculated using chi-square test.||||0.5642
70902783|NCT01557322|141293375|SUPERIORITY_OR_OTHER|||||||0.0034|TWO_SIDED||||||Chi-squared|||Death Due to AE, Month 24: p-value was calculated using chi-square test.||||0.0034
70902784|NCT01557322|141293375|SUPERIORITY_OR_OTHER|||||||0.7137|TWO_SIDED||||||Chi-squared|||Death Due to AE, Month 36: p-value was calculated using chi-square test.||||0.7137
70902785|NCT01557322|141293375|SUPERIORITY_OR_OTHER|||||||0.963|TWO_SIDED||||||Chi-squared|||Death Due to AE, Month 60: p-value was calculated using chi-square test.||||0.9630
70902786|NCT01557322|141293375|SUPERIORITY_OR_OTHER|||||||0.7353|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 6: p-value was calculated using chi-square test.||||0.7353
70902787|NCT01557322|141293375|SUPERIORITY_OR_OTHER|||||||0.3829|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 12: p-value was calculated using chi-square test.||||0.3829
70902788|NCT01557322|141293375|SUPERIORITY_OR_OTHER|||||||0.4532|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 18: p-value was calculated using chi-square test.||||0.4532
70902789|NCT01557322|141293375|SUPERIORITY_OR_OTHER|||||||0.4238|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 24: p-value was calculated using chi-square test.||||0.4238
70902790|NCT01557322|141293375|SUPERIORITY_OR_OTHER|||||||0.1218|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 30: p-value was calculated using chi-square test.||||0.1218
70902791|NCT01557322|141293375|SUPERIORITY_OR_OTHER|||||||0.4124|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 36: p-value was calculated using chi-square test.||||0.4124
70902792|NCT01557322|141293375|SUPERIORITY_OR_OTHER|||||||0.6356|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 48: p-value was calculated using chi-square test.||||0.6356
70902793|NCT01557322|141293375|SUPERIORITY_OR_OTHER|||||||0.5491|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 60: p-value was calculated using chi-square test.||||0.5491
70902794|NCT01557322|141293376|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Regression, Linear|||P-value was calculated using multivariate linear regression with baseline DAS28 score and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.||||<0.0001
70902795|NCT01557322|141293377|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Regression, Linear|||P-value was calculated using multivariate linear regression with baseline HAQ-DI score and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.||||<0.0001
70902796|NCT01557322|141293378|SUPERIORITY_OR_OTHER|||||||0.2558|TWO_SIDED||||||Regression, Linear|||PCS: p-value was calculated using multivariate linear regression with baseline PCS and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.||||0.2558
70902797|NCT01557322|141293378|SUPERIORITY_OR_OTHER|||||||0.4908|TWO_SIDED||||||Regression, Linear|||MCS: p-value was calculated using multivariate linear regression with baseline MCS and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.||||0.4908
70902798|NCT01557322|141293378|SUPERIORITY_OR_OTHER|||||||0.8379|TWO_SIDED||||||Regression, Linear|||Vitality Score: p-value was calculated using multivariate linear regression with baseline vitality score and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.||||0.8379
70902799|NCT02247336|141293380|SUPERIORITY||Odds Ratio (OR)|0.7||||0.16|TWO_SIDED|95.0|0.4|1.2||A priori threshold was 0.05.|Regression, Logistic|generalized estimating equation|Generalized estimating equation models were used with a logit link function and an exchangeable correlation structure to account for clustering of participants within provider. Fay and Graubard small sample bias correction was applied.|Using alpha=0.05, 80% power, and a risk-appropriate screening referral rate for the delayed arm ranging from 60% to 70%, n = 250 participants with a completed a family health history assessment per arm with 40 providers was needed to detect differences between arms in appropriate referral ranging from 12% to 13.2%. Sample size calculations accounted for provider clustering using an intra-class correlation coefficient of 0.02 to adjust variance for a Z-test of the difference of two proportions.||1.2|0.4|0.16
70902800|NCT02247336|141293381|SUPERIORITY||Odds Ratio (OR)|0.7||||0.23|TWO_SIDED|95.0|0.04|1.2||The a priori threshold was 0.05.|Regression, Logistic|generalized estimating equation|Generalized estimating equation models were used with a logit link function and an exchangeable correlation structure to account for clustering of participants within provider. Fay and Graubard small sample bias correction was applied.|||1.2|.04|0.23
70902801|NCT01986101|141293387|SUPERIORITY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|1.0||0.007|TWO_SIDED|95.0|-4.9|-1.0||Hochberg-adjusted|Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||-1.0|-4.9|0.007
70902802|NCT01986101|141293387|SUPERIORITY||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|1.03||0.057|TWO_SIDED|95.0|-4.0|0.1||Hochberg-adjusted.|Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||0.1|-4.0|0.057
70902803|NCT01986101|141293388|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.127||0.002|TWO_SIDED|95.0|-0.65|-0.15|||Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||-0.15|-0.65|0.002
70902804|NCT01986101|141293388|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.13||0.019|TWO_SIDED|95.0|-0.56|-0.05|||Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in SM-13496 group over the placebo group.|||-0.05|-0.56|0.019
70902805|NCT01986101|141293389|SUPERIORITY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.89||0.037|TWO_SIDED|95.0|-3.6|-0.1|||ANCOVA||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||-0.1|-3.6|0.037
70902806|NCT01986101|141293389|SUPERIORITY||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.92||0.223|TWO_SIDED|95.0|-2.9|0.7|||ANCOVA||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||0.7|-2.9|0.223
70902807|NCT01986101|141293390|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.262||0.076|TWO_SIDED|95.0|-0.98|0.05|||Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||0.05|-0.98|0.076
70902808|NCT01986101|141293390|SUPERIORITY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.269||0.075|TWO_SIDED|95.0|-1.01|0.05|||Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||0.05|-1.01|0.075
70902809|NCT01986101|141293391|SUPERIORITY||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.016|TWO_SIDED|95.0|-3.1|-0.3|||ANCOVA||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||-0.3|-3.1|0.016
70902810|NCT01986101|141293391|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.71||0.294|TWO_SIDED|95.0|-2.1|0.7|||ANCOVA||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||0.7|-2.1|0.294
70902811|NCT03324880|141293392|SUPERIORITY||Difference in Least Squares (LS) Mean|-0.53|STANDARD_ERROR_OF_MEAN|0.189|=|0.003|TWO_SIDED|95.0|-0.9|-0.15||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom subscale score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom subscale score.|-0.15|-0.90|=0.003
70902812|NCT03324880|141293393|SUPERIORITY||Difference in LS Mean|10.5|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|5.1|15.9||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in FACIT-Fatigue total score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline FACIT-Fatigue total score.|15.9|5.1|<0.001
70902813|NCT03324880|141293394|SUPERIORITY||Difference in LS Mean|4.242|STANDARD_ERROR_OF_MEAN|1.9219|=|0.015|TWO_SIDED|95.0|0.413|8.072||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 PCS score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 PCS score.|8.072|0.413|=0.015
70902814|NCT03324880|141293395|SUPERIORITY||Difference in LS Mean|-0.32|STANDARD_ERROR_OF_MEAN|0.112|=|0.002|TWO_SIDED|95.0|-0.55|-0.1||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD impact subscale score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD impact subscale score.|-0.10|-0.55|=0.002
70902815|NCT03324880|141293396|SUPERIORITY||Difference in LS Mean|-0.28|STANDARD_ERROR_OF_MEAN|0.125|=|0.013|TWO_SIDED|95.0|-0.53|-0.04||1-sided p-value was reported.|MMRM|||Impact on Sleep|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD impact item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD impact item score.|-0.04|-0.53|=0.013
70902816|NCT03324880|141293396|SUPERIORITY||Difference in LS Mean|-0.36|STANDARD_ERROR_OF_MEAN|0.128|=|0.003|TWO_SIDED|95.0|-0.61|-0.11||1-sided p-value was reported.|MMRM|||Ability to Exercise|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD impact item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD impact item score.|-0.11|-0.61|=0.003
70902817|NCT03324880|141293396|SUPERIORITY||Difference in LS Mean|-0.36|STANDARD_ERROR_OF_MEAN|0.123|=|0.002|TWO_SIDED|95.0|-0.61|-0.12||1-sided p-value was reported.|MMRM|||Ability to Complete Work|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD impact item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD impact item score.|-0.12|-0.61|=0.002
70902818|NCT03324880|141293396|SUPERIORITY||Difference in LS Mean|-0.37|STANDARD_ERROR_OF_MEAN|0.121|=|0.002|TWO_SIDED|95.0|-0.61|-0.13||1-sided p-value was reported.|MMRM|||Impact Family Relationships|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD impact item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD impact item score.|-0.13|-0.61|=0.002
70902819|NCT03324880|141293397|SUPERIORITY||Difference in LS Mean|-0.55|STANDARD_ERROR_OF_MEAN|0.203|=|0.004|TWO_SIDED|95.0|-0.96|-0.15||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD anxiety item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD anxiety item score.|-0.15|-0.96|=0.004
70902820|NCT03324880|141293398|SUPERIORITY||Difference in LS Mean|-0.54|STANDARD_ERROR_OF_MEAN|0.2|=|0.004|TWO_SIDED|95.0|-0.93|-0.14||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD sadness or depression item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD sadness or depression item score.|-0.14|-0.93|=0.004
70902821|NCT03324880|141293399|SUPERIORITY||Difference in LS Mean|-0.56|STANDARD_ERROR_OF_MEAN|0.218|=|0.006|TWO_SIDED|95.0|-0.99|-0.12||1-sided p-value was reported.|MMRM|||Muscle Cramps|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|-0.12|-0.99|=0.006
70902822|NCT03324880|141293399|SUPERIORITY||Difference in LS Mean|-0.54|STANDARD_ERROR_OF_MEAN|0.213|=|0.007|TWO_SIDED|95.0|-0.96|-0.12||1-sided p-value was reported.|MMRM|||Tingling|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|-0.12|-0.96|=0.007
70902823|NCT03324880|141293399|SUPERIORITY||Difference in LS Mean|-0.48|STANDARD_ERROR_OF_MEAN|0.231|=|0.02|TWO_SIDED|95.0|-0.94|-0.02||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|-0.02|-0.94|=0.020
70902824|NCT03324880|141293399|SUPERIORITY||Difference in LS Mean|-0.62|STANDARD_ERROR_OF_MEAN|0.219|=|0.003|TWO_SIDED|95.0|-1.05|-0.18||1-sided p-value was reported.|MMRM|||Muscle Spasms|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|-0.18|-1.05|=0.003
70902825|NCT03324880|141293399|SUPERIORITY||Difference in LS Mean|-0.38|STANDARD_ERROR_OF_MEAN|0.229|=|0.05|TWO_SIDED|95.0|-0.83|0.07||1-sided p-value was reported.|MMRM|||Feelings of Heaviness|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|0.07|-0.83|=0.050
70902826|NCT03324880|141293399|SUPERIORITY||Difference in LS Mean|-0.55|STANDARD_ERROR_OF_MEAN|0.227|=|0.008|TWO_SIDED|95.0|-1.01|-0.1||1-sided p-value was reported.|MMRM|||Physical Fatigue|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|-0.10|-1.01|=0.008
70902827|NCT03324880|141293399|SUPERIORITY||Difference in LS Mean|-0.51|STANDARD_ERROR_OF_MEAN|0.186|=|0.004|TWO_SIDED|95.0|-0.87|-0.14||1-sided p-value was reported.|MMRM|||Brain Fog|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|-0.14|-0.87|=0.004
70902828|NCT03324880|141293401|SUPERIORITY||Difference in LS Mean|-0.9|STANDARD_ERROR_OF_MEAN|0.235|<|0.001|TWO_SIDED|95.0|-1.37|-0.43||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD most bothersome symptom score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD most bothersome symptom score.|-0.43|-1.37|<0.001
70902829|NCT03324880|141293402|SUPERIORITY||Difference in LS Mean|2.1|STANDARD_ERROR_OF_MEAN|1.07|=|0.024|TWO_SIDED|95.0|0.0|4.3||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in FACT-Cog Perceived Cognitive Impairments Subscale score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline FACT-Cog Perceived Cognitive Impairments Subscale score.|4.3|0.0|=0.024
70902830|NCT03324880|141293403|SUPERIORITY||Difference in LS Mean|2.1|STANDARD_ERROR_OF_MEAN|1.07|=|0.024|TWO_SIDED|95.0|0.0|4.3||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in FACT-Cog QoL Subscale score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline FACT-Cog QoL Subscale score.|4.3|0.0|=0.024
70902831|NCT03324880|141293404|SUPERIORITY||Difference in LS Mean|7.21|STANDARD_ERROR_OF_MEAN|2.1376|=|0.001|TWO_SIDED|95.0|2.951|11.469||1-sided p-value was reported.|MMRM|||Standard-Bodily Pain|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|11.469|2.951|=0.001
70902832|NCT03324880|141293404|SUPERIORITY||Difference in LS Mean|5.545|STANDARD_ERROR_OF_MEAN|2.0542|=|0.004|TWO_SIDED|95.0|1.452|9.638||1-sided p-value was reported.|MMRM|||Standard-General Health|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|9.638|1.452|=0.004
70902833|NCT03324880|141293404|SUPERIORITY||Difference in LS Mean|7.857|STANDARD_ERROR_OF_MEAN|2.2913|<|0.001|TWO_SIDED|95.0|3.292|12.423||1-sided p-value was reported.|MMRM|||Standard-Mental Health|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|12.423|3.292|<0.001
70902834|NCT03324880|141293404|SUPERIORITY||MMRM|4.554|STANDARD_ERROR_OF_MEAN|2.1123|=|0.017|TWO_SIDED|95.0|0.345|8.763||1-sided p-value was reported.|MMRM|||Standard-Physical Functioning|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|8.763|0.345|=0.017
70902835|NCT03324880|141293404|SUPERIORITY||Difference in LS Mean|8.42|STANDARD_ERROR_OF_MEAN|2.3186|<|0.001|TWO_SIDED|95.0|3.8|13.04||1-sided p-value was reported.|MMRM|||Standard-Role-Emotional|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|13.040|3.800|<0.001
70902836|NCT03324880|141293404|SUPERIORITY||Difference in LS Mean|4.23|STANDARD_ERROR_OF_MEAN|2.2489|=|0.032|TWO_SIDED|95.0|-0.251|8.711||1-sided p-value was reported.|MMRM|||Standard-Role-Physical|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|8.711|-0.251|=0.032
70902837|NCT03324880|141293404|SUPERIORITY||Difference in LS Mean|3.809|STANDARD_ERROR_OF_MEAN|2.6658|=|0.079|TWO_SIDED|95.0|-1.502|9.121||1-sided p-value was reported.|MMRM|||Standard-Social Functioning|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|9.121|-1.502|=0.079
70902838|NCT03324880|141293404|SUPERIORITY||Difference in LS Mean|7.942|STANDARD_ERROR_OF_MEAN|2.353|=|0.001|TWO_SIDED|95.0|3.253|12.63||1-sided p-value was reported.|MMRM|||Standard-Vitality|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|12.630|3.253|=0.001
70902839|NCT03324880|141293405|SUPERIORITY||Difference in LS Mean|8.3|STANDARD_ERROR_OF_MEAN|2.2642|<|0.001|TWO_SIDED|95.0|3.788|12.811||1-sided p-value|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 MCS score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 MCS score.|12.811|3.788|<0.001
70902840|NCT03324880|141293406|SUPERIORITY||Difference in LS Mean|3.13|STANDARD_ERROR_OF_MEAN|9.578|=|0.627|TWO_SIDED|95.0|-16.33|22.6||1-sided p-value was reported.|MMRM|||Percent Work Time Missed Due to Problem|MMRM analysis over all post-baseline visits, with the change from baseline in WPAI score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline WPAI score.|22.60|-16.33|=0.627
70902841|NCT03324880|141293406|SUPERIORITY||Difference in LS Mean|-14.6|STANDARD_ERROR_OF_MEAN|7.52|=|0.031|TWO_SIDED|95.0|-29.9|0.7||1-sided p-value was reported.|MMRM|||Percent Impairment While Working Due to Problem|MMRM analysis over all post-baseline visits, with the change from baseline in WPAI score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline WPAI score.|0.7|-29.9|=0.031
70902842|NCT03324880|141293406|SUPERIORITY||Difference in LS Mean|-14.9|STANDARD_ERROR_OF_MEAN|6.146|=|0.011|TWO_SIDED|95.0|-27.42|-2.39||1-sided p-value was reported.|MMRM|||Percent Overall Work Impairment Due to Problem|MMRM analysis over all post-baseline visits, with the change from baseline in WPAI score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline WPAI score.|-2.39|-27.42|=0.011
70902843|NCT03324880|141293406|SUPERIORITY||Difference in LS Mean|-13.0|STANDARD_ERROR_OF_MEAN|5.78|=|0.014|TWO_SIDED|95.0|-24.5|-1.5||1-sided p-value was reported.|MMRM|||Percent Activity Impairment Due to Problem|MMRM analysis over all post-baseline visits, with the change from baseline in WPAI score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline WPAI score.|-1.5|-24.5|=0.014
70902844|NCT03324880|141293407|SUPERIORITY||Difference in LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|0.22|=|0.01|TWO_SIDED|95.0|-1.0|-0.1||1-sided p-value|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in PGI-S score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline PGI-S score.|-0.1|-1.0|=0.010
70902845|NCT03324880|141293409|SUPERIORITY||Difference in LS Mean|0.01|||=|0.516|TWO_SIDED|95.0|-0.03|0.05|||ANCOVA|From an Analysis of Covariance (ANCOVA) with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||Detection||0.05|-0.03|=0.516
70902846|NCT03324880|141293409|SUPERIORITY||Difference in LS Mean|0.02|||=|0.275|TWO_SIDED|95.0|-0.02|0.06|||ANCOVA|From an ANCOVA with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||Identification||0.06|-0.02|=0.275
70902847|NCT03324880|141293409|SUPERIORITY||Difference in LS Mean|0.01|||=|0.777|TWO_SIDED|95.0|-0.05|0.07|||ANCOVA|From an ANCOVA with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||One Card Learning||0.07|-0.05|=0.777
70902848|NCT03324880|141293409|SUPERIORITY||Difference in LS Mean|0.01|||=|0.831|TWO_SIDED|95.0|-0.04|0.05|||ANCOVA|From an ANCOVA with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||One Back (ONB)||0.05|-0.04|=0.831
70902849|NCT03324880|141293409|SUPERIORITY||Difference in LS Mean|9.93|||=|0.075|TWO_SIDED|95.0|-1.0|20.85|||ANCOVA|From an ANCOVA with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||Groton Maze Learning (GML)||20.85|-1.00|=0.075
70902850|NCT03324880|141293409|SUPERIORITY||Difference in LS Mean|-0.57|||=|0.545|TWO_SIDED|95.0|-2.41|1.27|||ANCOVA|From an ANCOVA with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||International Shopping List (ISL)||1.27|-2.41|=0.545
70902851|NCT03324880|141293409|SUPERIORITY||Difference in LS Mean|0.55|||=|0.283|TWO_SIDED|95.0|-0.45|1.56|||ANCOVA|From an ANCOVA with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||International Shopping List Test Delayed Recall (ISRL)||1.56|-0.45|=0.283
70902852|NCT03324880|141293410|SUPERIORITY||Difference in LS Mean|0.01|||=|0.582|TWO_SIDED|95.0|-0.02|0.04||1-sided p-value was reported.|MMRM|||Detection (DET)|From MMRM with visit, treatment group, and visit treatment group as fixed effects, Baseline score as a covariate, and participant as a random effect. By-participant scores, which are summarized in this table, are derived as the average of the planned at-home assessment values that passed the Completion criteria over 14 days preceding the visit.|0.04|-0.02|=0.582
70902853|NCT03324880|141293410|SUPERIORITY||Difference in LS Mean|0.01|||=|0.492|TWO_SIDED|95.0|-0.02|0.04||1-sided p-value was reported.|MMRM|||Identification (IDN)|From MMRM with visit, treatment group, and visit treatment group as fixed effects, Baseline score as a covariate, and participant as a random effect. By-participant scores, which are summarized in this table, are derived as the average of the planned at-home assessment values that passed the Completion criteria over 14 days preceding the visit.|0.04|-0.02|=0.492
70902854|NCT03324880|141293410|SUPERIORITY||Difference in LS Mean|0.01|||=|0.506|TWO_SIDED|95.0|-0.03|0.06||1-sided p-value was reported.|MMRM|||One Card Learning (OCL)|From MMRM with visit, treatment group, and visit treatment group as fixed effects, Baseline score as a covariate, and participant as a random effect. By-participant scores, which are summarized in this table, are derived as the average of the planned at-home assessment values that passed the Completion criteria over 14 days preceding the visit.|0.06|-0.03|=0.506
70902855|NCT03324880|141293410|SUPERIORITY||Difference in LS Mean|0.01|||=|0.438|TWO_SIDED|95.0|-0.02|0.04||1-sided p-value was reported.|MMRM|||One Back Test|From MMRM with visit, treatment group, and visit treatment group as fixed effects, Baseline score as a covariate, and participant as a random effect. By-participant scores, which are summarized in this table, are derived as the average of the planned at-home assessment values that passed the Completion criteria over 14 days preceding the visit.|0.04|-0.02|=0.438
70902856|NCT03324880|141293411|SUPERIORITY||Difference in LS Mean|2.09|STANDARD_ERROR_OF_MEAN|0.871|=|0.991|TWO_SIDED|95.0|0.36|3.83||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in 24-hour urine calcium excretion as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline 24-Hour urine calcium excretion.|3.83|0.36|=0.991
70902857|NCT03324880|141293412|SUPERIORITY||Difference in LS Mean|-0.175|STANDARD_ERROR_OF_MEAN|0.0395|<|0.001|TWO_SIDED|95.0|-0.254|-0.097||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in serum phosphate as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline serum phosphate.|-0.097|-0.254|<0.001
70902858|NCT03324880|141293413|SUPERIORITY||Difference in LS Mean|4.08|STANDARD_ERROR_OF_MEAN|4.654|=|0.81|TWO_SIDED|95.0|-5.06|13.22||1-sided p-value was reported.|MMRM||||From a mixed-effects model for repeated measures (MMRM) analysis over all post-baseline visits, with the change from baseline in active vitamin D supplement dose as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline active vitamin D supplement dose.|13.22|-5.06|=0.810
70902859|NCT03324880|141293414|SUPERIORITY||Difference in LS Mean|-331.3|STANDARD_ERROR_OF_MEAN|132.56|=|0.007|TWO_SIDED|95.0|-594.6|-67.9||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in elemental calcium supplement dose as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline elemental calcium supplement dose.|-67.9|-594.6|=0.007
70902860|NCT03324880|141293417|SUPERIORITY||Difference in LS Mean|22.33|STANDARD_ERROR_OF_MEAN|3.271|<|0.001|TWO_SIDED|95.0|15.83|28.84||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in bone turnover biomarkers as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline bone turnover biomarkers.|28.84|15.83|<0.001
70902861|NCT03324880|141293418|SUPERIORITY||Difference in LS Mean|785.5|STANDARD_ERROR_OF_MEAN|113.65|<|0.001|TWO_SIDED|95.0|559.6|1011.3||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in bone turnover biomarkers as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline bone turnover biomarkers.|1011.3|559.6|<0.001
70902862|NCT03324880|141293419|SUPERIORITY||Difference in LS Mean|56.43|STANDARD_ERROR_OF_MEAN|6.091|<|0.001|TWO_SIDED|95.0|44.33|68.53||1-sided p-value was reported.|MMRM|||Osteocalcin|MMRM analysis over all post-baseline visits, with the change from baseline in bone turnover biomarkers as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline bone turnover biomarkers.|68.53|44.33|<0.001
70902863|NCT03324880|141293419|SUPERIORITY||Difference in LS Mean|226.57|STANDARD_ERROR_OF_MEAN|33.425|<|0.001|TWO_SIDED|95.0|160.17|292.98||1-sided p-value was reported.|MMRM|||Procollagen 1 N-Terminal Propeptide|MMRM analysis over all post-baseline visits, with the change from baseline in bone turnover biomarkers as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline bone turnover biomarkers.|292.98|160.17|<0.001
70902864|NCT03300570|141293421|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
70902865|NCT00116272|141293424|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.77|||||TWO_SIDED|95.0|1.04|7.35|||||Adjusted oddds ratio for major structural defects in women exposed to etanercept in their 1st trimester versus not exposed computed using logistic regression adjusted for propensity score comprised of asthma and maternal height|||7.35|1.04|
70902866|NCT00116272|141293425|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.37|||||TWO_SIDED|95.0|1.02|5.52|||||Adjusted oddds ratio for major structural defects in women exposed to etanercept in their 1st trimester versus not exposed computed using logistic regression adjusted for propensity score comprised of asthma and maternal height|||5.52|1.02|
70902867|NCT00116272|141293426|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.7|2.01|||||Unadjusted Odds Ratio computed using logistic regression. No adjusted estimate was computed due to no confirmed confounder.|||2.01|0.70|
70902868|NCT00116272|141293428|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.2|1.12|||||Adjusted HR computed using Cox proportional hazards regression adjusted for propensity score comprised of referral source (3 categories: OTIS, Pharmaceutical Company/Sponsor/HCP, Patient Support Group/Internet/Other), and maternal height.|||1.12|0.20|
70902869|NCT00116272|141293429|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.6|||||TWO_SIDED|95.0|0.86|2.98|||||Adjusted HR computed using Cox proportional hazards regression adjusted for preeclampsia|||2.98|0.86|
70902870|NCT00116272|141293430|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|-0.2|||||TWO_SIDED|95.0|-0.65|0.26|||||Computed using linear regression, directly adjusted for referral source (not collapsed), vitamin use (not collapsed), preeclampsia, and asthma because propensity score adjustment was not balanced.|||0.26|-0.65|
70902871|NCT00116272|141293431|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|21.79|||||TWO_SIDED|95.0|-83.32|126.91|||||Computed using linear regression, directly adjusted for asthma, RA2 severity score at 32 weeks, and disease severity score imputation indicator because propensity score adjustment was not balanced.|||126.91|-83.32|
70963638|NCT02273726|141432207|SUPERIORITY|Superiority was declared if the upper bound of the 2-sided 95% CI of the difference between roxadustat and epoetin alfa (roxadustat - epoetin alpha) was less than 0.|Least Square Mean Difference|-14.67|STANDARD_ERROR_OF_MEAN|1.514|<|0.0001|TWO_SIDED|95.0|-17.64|-11.695|||Mixed Models Analysis|||Treatment comparison was made using a MMRM with baseline as a covariate, and treatment, visit, visit-by-treatment interaction, ESA dependent incident dialysis within ≤4 months vs. \>4 months of starting dialysis when randomized, and randomization stratification factors as fixed effects.||-11.695|-17.640|<0.0001
70963639|NCT02273726|141432208|NON_INFERIORITY|The non-inferiority margin was fixed as a difference of -0.75.|LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.093|<|0.0001|TWO_SIDED|95.0|0.503|0.869||Threshold for significance at 0.05 level.|ANCOVA|ANCOVA with MI||Treatment comparison was made using the MI strategy by combining the results of ANCOVA model with baseline Hb as a covariate, and treatment, ESA dependent incident dialysis within ≤4 months vs. \>4 months of starting dialysis when randomized, and other randomization stratification factors except mean qualifying screening Hb (≤10.5 vs. \>10.5 g/dL) as fixed effects.||0.869|0.503|<0.0001
70963640|NCT02273726|141432209|SUPERIORITY||LS Mean Difference|-20.14|STANDARD_ERROR_OF_MEAN|6.975||0.00091|TWO_SIDED|95.0|-33.842|-6.445||Threshold for significance at 0.05 level.|Rank ANCOVA|||Treatment comparison was made using an ANCOVA model with baseline iron repletion status, treatment, ESA dependent incident dialysis within ≤4 months vs. \>4 months of starting dialysis when randomized, and randomization stratification factors as fixed effects.||-6.445|-33.842|0.00091
70963641|NCT02273726|141432210|NON_INFERIORITY|The non-inferiority margin for the difference between groups was 1.8.|Hazard Ratio (HR)|0.67||||0.0337|TWO_SIDED|95.0|0.466|0.97|||Cox Proportional Hazards model|||Analysis was done using a Cox Proportional Hazards model adjusting for baseline Hb and other stratification factors except mean qualifying screening Hb (≤10.5 vs. \>10.5 g/dL) as fixed effects.||0.970|0.466|0.0337
70902872|NCT00116272|141293432|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|0.1|||||TWO_SIDED|95.0|-0.44|0.63|||||Computed using linear regression, adjusted for propensity score comprised of preeclampsia and asthma.|||0.63|-0.44|
70902873|NCT00116272|141293433|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|-0.09|||||TWO_SIDED|95.0|-0.43|0.26|||||Computed using linear regression, adjusted for maternal age (categorical).|||0.26|-0.43|
70902874|NCT00116272|141293434|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.48|||||TWO_SIDED|95.0|0.22|1.05|||||Computed using logistic regression, adjusted for propensity score comprised of maternal height, referral source (OTIS, Sponsor/HCP, Patient Support Group/Internet/Other), PsO disease severity score at 32 weeks, \& disease severity imputation indicator|||1.05|0.22|
70902875|NCT00116272|141293435|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.72|||||TWO_SIDED|95.0|0.31|1.68|||||Unadjusted Odds Ratio computed using logistic regression. An adjusted estimate was not computed due to the small number of events.|||1.68|0.31|
70902876|NCT00116272|141293436|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.4|1.57|||||Computed using logistic regression, adjusted for propensity score comprised of maternal height, referral source (OTIS, Sponsor/HCP, Patient Support Group/Internet/Other), PsO disease severity score at 32 weeks, \& disease severity imputation indicator|||1.57|0.40|
70902877|NCT00116272|141293437|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|0.2|||||TWO_SIDED|95.0|-7.59|7.99|||||Computed using linear regression, adjusted for propensity score comprised of maternal height, vitamin use, primary disease, RA disease severity score at 32 weeks, PsO disease severity score at intake \& 32 weeks, disease severity imputation indicators|||7.99|-7.59|
70902878|NCT00116272|141293438|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|1.53|||||TWO_SIDED|95.0|-5.76|8.81|||||Computed using linear regression, adjusted for propensity score comprised of maternal height, maternal age (categorical), and referral source (3 categories: OTIS, Pharmaceutical Company/Sponsor/HCP, Patient Support Group/Internet/Other).|||8.81|-5.76|
70902879|NCT00116272|141293439|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|0.27|||||TWO_SIDED|95.0|-6.12|6.65|||||Computed using linear regression. Directly adjusted for infant sex and other autoimmune diseases because propensity score adjustment was not balanced.|||6.65|-6.12|
70902880|NCT00116272|141293440|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.37|1.62|||||Computed using logistic regression, adjusted for propensity score comprised of maternal height, RA disease severity score at 32 weeks, and disease severity score imputation indicator.|||1.62|0.37|
70902881|NCT00116272|141293441|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17|||||TWO_SIDED|95.0|0.43|3.14|||||Computed using logistic regression, adjusted for propensity score comprised of country (U.S., Canada), primary disease, and maternal height.|||3.14|0.43|
70902882|NCT00116272|141293442|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.29|2.65|||||Unadjusted Odds Ratio computed using logistic regression. An adjusted estimate was not computed due to the small number of events.|||2.65|0.29|
70902883|NCT00116272|141293443|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.47|4.02|||||Unadjusted Odds Ratio computed using logistic regression. An adjusted estimate was not computed due to no confirmed confounder.|||4.02|0.47|
70902884|NCT00116272|141293445|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.65|1.69|||||Unadjusted Odds Ratio computed using logistic regression. An adjusted estimate was not computed due to no confirmed confounder.|||1.69|0.65|
70902885|NCT02296190|141293453|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||Statistical analysis was performed with the Fisher's exact test to compare the conversion rate between the MSP-2017 groups and the placebo group.||||<0.05
70902886|NCT00402337|141293465|SUPERIORITY_OR_OTHER|||||||0.0337||95.0|||||ANCOVA|||The null hypothesis is that the active treatment group is equal to the placebo group.||||0.0337
70902887|NCT00402337|141293465|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||The null hypothesis is that the active treatment group is equal to the placebo group.||||0.0010
70902888|NCT00402337|141293465|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||The null hypothesis is that the active treatment group is equal to the placebo group.||||<0.0001
70902889|NCT00402337|141293465|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||The null hypothesis is that the active treatment group is equal to the placebo group.||||<0.0001
70902890|NCT02821819|141293471|NON_INFERIORITY|The sample size was calculated assuming a non-inferiority margin of 5 eggs SD 6.7. A unilateral alpha level of 0.05 was stablished. With the aim to show that the difference in the mean number of collected eggs will not exceed 5, a statistical power of 80% required 30 patients per group (1:1 allocation, total sample: 60).|Mean Difference (Final Values)|18.0|STANDARD_DEVIATION|8.1||0.8|ONE_SIDED|||||a priori threshold for statistical significance: \<0.05|t-test, 1 sided|||The sample size was calculated assuming a non-inferiority margin of 5 eggs and a standard deviation (SD) of 6.7. A unilateral alpha level of 0.05 was stablished. With the aim to show that the difference in the mean number of collected eggs will not exceed 5, a statistical power of 80% required 30 patients per group (1:1 allocation, total sample: 60).|"Since the number of collected eggs constitutes the main outcome of the study, the sample size was calculated assuming a non-inferiority margin of 5 eggs with an standard deviation of 6.7. A unilateral alpha level of 0.05 was stablished. With the aim to show that the difference in the mean number of collected eggs will not exceed 5, a statistical power of 80% required 30 patients per group (1:1 allocation, total sample: 60).~Statistical analysis was performed using t-student test for continuous variables and chi-square test for categorical parameters. A P value of \<.05 was considered significant."|||0.8
70902891|NCT02821819|141293471|NON_INFERIORITY|The sample size was calculated assuming a non-inferiority margin of 5 eggs SD 6.7. A unilateral alpha level of 0.05 was stablished. With the aim to show that the difference in the mean number of collected eggs will not exceed 5, a statistical power of 80% required 30 patients per group (1:1 allocation, total sample: 60). Statistical analysis used t-student test for continuous variables and chi-square test for categorical parameters.|Mean Difference (Final Values)|82.0||||0.8|TWO_SIDED|||||a priori threshold for statistical significance: \<0.05|Chi-squared|||The sample size was calculated assuming a non-inferiority margin of 5 eggs SD 6.7. A unilateral alpha level of 0.05 was stablished. With the aim to show that the difference in the mean number of collected eggs will not exceed 5, a statistical power of 80% required 30 patients per group (1:1 allocation, total sample: 60). Statistical analysis used t-student test for continuous variables and chi-square test for categorical parameters.||||0.8
70902892|NCT02821819|141293472|NON_INFERIORITY|Statistical analysis was performed using t-student test for continuous variables and chi-square test for categorical parameters. A P value of \<.05 was considered significant.|Median Difference (Final Values)|71.1|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
70902893|NCT02081950|141293476|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|93.65|||||TWO_SIDED|90.0|87.56|100.16||||||||100.16|87.56|
70902894|NCT02081950|141293477|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|100.46|||||TWO_SIDED|90.0|95.74|105.42||||||||105.42|95.74|
70902895|NCT02081950|141293478|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|101.16|||||TWO_SIDED|90.0|96.32|106.24||||||||106.24|96.32|
70902896|NCT02081950|141293479|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|94.88|||||TWO_SIDED|90.0|88.49|101.73||||||||101.73|88.49|
70902897|NCT02081950|141293480|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|97.13|||||TWO_SIDED|90.0|89.93|104.91||||||||104.91|89.93|
70902898|NCT02081950|141293481|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|108.84|||||TWO_SIDED|90.0|95.61|123.91||||||||123.91|95.61|
70902899|NCT02081950|141293492|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|102.45|||||TWO_SIDED|90.0|96.31|109.0||||||||109.0|96.31|
70902900|NCT02081950|141293493|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|geometric least square mean ratio|95.84|||||TWO_SIDED|90.0|79.11|116.11||||||||116.11|79.11|
70902901|NCT02081950|141293495|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|geometric least square mean ratio|99.54|||||TWO_SIDED|90.0|95.69|103.54||||||||103.54|95.69|
70902902|NCT02081950|141293499|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|geometric least square mean ratio|98.36|||||TWO_SIDED|90.0|95.31|101.51||||||||101.51|95.31|
70902903|NCT02081950|141293500|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject|geometric least square mean ratio|111.3|||||TWO_SIDED|90.0|99.73|124.2||||||||124.2|99.73|
70902904|NCT02081950|141293503|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject|geometric least square mean ratio|98.7|||||TWO_SIDED|90.0|93.16|104.57||||||||104.57|93.16|
70902905|NCT02081950|141293504|OTHER||geometric least square mean ratio|103.43|||||TWO_SIDED|90.0|94.5|113.2||||||||113.2|94.5|
70902906|NCT02081950|141293505|OTHER||geometric least square mean ratio|92.92|||||TWO_SIDED|90.0|80.58|107.16||||||||107.16|80.58|
70902907|NCT00110890|141293510|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.74|||<|0.001||95.0|5.72|13.36|||Cochran-Mantel-Haenszel|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|||13.36|5.72|<0.001
70902908|NCT00110890|141293511|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.74|||<|0.001||95.0|5.38|14.19|||Cochran-Mantel-Haenszel|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|||14.19|5.38|<0.001
70902909|NCT00110890|141293512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.11|||<|0.001||95.0|2.0|4.84|||Cochran-Mantel-Haenszel|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|||4.84|2.00|<0.001
70902910|NCT00110890|141293513|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.93|||<|0.001||95.0|4.65|10.34|||Cochran-Mantel-Haenszel|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|||10.34|4.65|<0.001
70902911|NCT00110890|141293514|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88||||0.002||95.0|1.26|2.81|||Cochran-Mantel-Haenszel|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|||2.81|1.26|0.002
70902912|NCT01975220|141293515|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|99.98|STANDARD_DEVIATION|5.4|<|0.0001|TWO_SIDED|90.0|97.275|102.751|||ANOVA||Adjusted geometric mean (GM) ratio(%) was calculated as GM of 'High dose, fasted:1 FDC tablet' divided by GM of 'High dose, fasted:3 single tablets'.The 'standard deviation' is actually intra-individual geometric coefficient of variation (gCV (%)).|||102.751|97.275|<0.0001
70902913|NCT01975220|141293515|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|97.09|STANDARD_DEVIATION|6.7|<|0.0001|TWO_SIDED|90.0|93.857|100.436|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||100.436|93.857|<0.0001
70902914|NCT01975220|141293515|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|100.7|STANDARD_DEVIATION|4.9|<|0.0001|TWO_SIDED|90.0|98.28|103.18|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||103.18|98.28|<0.0001
70902915|NCT01975220|141293516|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|94.65|STANDARD_DEVIATION|28.1||0.0256|TWO_SIDED|90.0|82.29|108.88|||ANOVA||The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).|||108.88|82.29|0.0256
70902916|NCT01975220|141293516|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|99.69|STANDARD_DEVIATION|7.1|<|0.0001|TWO_SIDED|90.0|96.25|103.26|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||103.26|96.25|<0.0001
70902917|NCT01975220|141293516|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|99.76|STANDARD_DEVIATION|24.2||0.002|TWO_SIDED|90.0|88.65|112.27|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||112.27|88.65|0.0020
70902918|NCT01975220|141293517|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|100.1|STANDARD_DEVIATION|5.1|<|0.0001|TWO_SIDED|90.0|97.555|102.719|||ANOVA||The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).|||102.719|97.555|<0.0001
70902919|NCT01975220|141293517|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|97.01|STANDARD_DEVIATION|7.0|<|0.0001|TWO_SIDED|90.0|93.622|100.531|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||100.531|93.622|<0.0001
70902920|NCT01975220|141293517|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|100.78|STANDARD_DEVIATION|4.9|<|0.0001|TWO_SIDED|90.0|98.36|103.27|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||103.27|98.36|<0.0001
70902921|NCT01975220|141293518|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|109.07|STANDARD_DEVIATION|17.4||0.0072|TWO_SIDED|90.0|99.892|119.1|||ANOVA||The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).|||119.100|99.892|0.0072
70902922|NCT01975220|141293518|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|92.42|STANDARD_DEVIATION|12.5||0.0004|TWO_SIDED|90.0|86.781|98.428|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||98.428|86.781|0.0004
70902923|NCT01975220|141293518|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|105.37|STANDARD_DEVIATION|17.7||0.0014|TWO_SIDED|90.0|96.6|114.942|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||114.942|96.600|0.0014
70902924|NCT01975220|141293519|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|96.65|STANDARD_DEVIATION|29.8||0.0198|TWO_SIDED|90.0|83.337|112.079|||ANOVA||The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).|||112.079|83.337|0.0198
70902925|NCT01975220|141293519|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|110.17|STANDARD_DEVIATION|12.0||0.0007|TWO_SIDED|90.0|103.809|116.926|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||116.926|103.809|0.0007
70902926|NCT01975220|141293519|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|97.68|STANDARD_DEVIATION|23.8||0.0037|TWO_SIDED|90.0|86.942|109.734|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||109.734|86.942|0.0037
70902927|NCT01975220|141293520|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|95.4|STANDARD_DEVIATION|29.4||0.0254|TWO_SIDED|90.0|82.42|110.44|||ANOVA||The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).|||110.44|82.42|0.0254
70902928|NCT01975220|141293520|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|99.63|STANDARD_DEVIATION|7.1|<|0.0001|TWO_SIDED|90.0|96.21|103.17|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||103.17|96.21|<0.0001
70902929|NCT01975220|141293520|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|101.06|STANDARD_DEVIATION|24.4||0.0029|TWO_SIDED|90.0|89.7|113.86|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||113.86|89.70|0.0029
70902930|NCT01960530|141293547|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To investigate the absolute and relative bioavailability of cortisol from oral Infacort®, a 20 mg dose of oral Infacort® was compared to a 20 mg dose of i.v. hydrocortisone and hydrocortisone tablets, respectively (Study Periods 3-5). These investigations were conducted in dexamethasone suppressed healthy subjects. Standard bioavailability limits of 80% to 125% were used.|Geometric LSmean ratio|60.12|||||TWO_SIDED|90.0|54.69|66.1||||||Evaluation of Cmax||66.10|54.69|
70902931|NCT01960530|141293547|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To investigate the absolute and relative bioavailability of cortisol from oral Infacort®, a 20 mg dose of oral Infacort® was compared to a 20 mg dose of i.v. hydrocortisone and hydrocortisone tablets, respectively (Study Periods 3-5). These investigations were conducted in dexamethasone suppressed healthy subjects. Standard bioavailability limits of 80% to 125% were used.|Geometric LSmean ratio|106.83|||||TWO_SIDED|90.0|96.92|117.76||||||||117.76|96.92|
70902932|NCT01960530|141293552|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|86.99|||||TWO_SIDED|90.0|79.23|95.52||||||||95.52|79.23|
70902933|NCT01960530|141293552|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|89.96|||||TWO_SIDED|90.0|81.72|99.04||||||||99.04|81.72|
70902934|NCT01301274|141293553|NON_INFERIORITY_OR_EQUIVALENCE|beta error 20%, alfa error 5%, diminished 2 mEq/L between groups||||||0.04||95.0|||||t-test, 2 sided|||||||0.04
70902935|NCT01301274|141293554|SUPERIORITY_OR_OTHER|||||||0.081||95.0||||without adjust|Chi-squared|||||||0.081
70902936|NCT01301274|141293555|SUPERIORITY_OR_OTHER|||||||0.396||95.0|||||t-test, 2 sided|||||||0.396
70902937|NCT01301274|141293556|SUPERIORITY_OR_OTHER|||||||0.129||95.0|||||t-test, 2 sided|||||||0.129
70902938|NCT02439749|141293622|SUPERIORITY||||||<|0.001||||||p\<0.05 required for significance|ANCOVA|||||||<0.001
70902939|NCT02439749|141293626|SUPERIORITY|||||||0.026||||||p\<0.05 required for significance.|ANCOVA|||||||0.026
70902940|NCT02439749|141293627|SUPERIORITY|||||||0.052||||||p\<0.05 required for significance.|ANCOVA|||||||0.052
70902941|NCT02439749|141293628|SUPERIORITY|||||||0.07||||||p\<0.05 required for significance.|ANCOVA|||||||0.070
70902942|NCT02439749|141293629|SUPERIORITY|||||||0.009||||||p=\<0.05 required for significance.|ANCOVA|||||||0.009
70902943|NCT00445679|141293654|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority to paroxetine was declared if the lower limit of the 95% two-sided confidence interval for the difference in responders is greater than or equal to -9 percentage points.|Difference|-3.13|||||TWO_SIDED|95.0|-12.62|6.37||||||||6.37|-12.62|
70902944|NCT00445679|141293654|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority to paroxetine was declared if the lower limit of the 95% two-sided confidence interval for the difference in responders is greater than or equal to -9 percentage points.|Difference|0.88|||||TWO_SIDED|95.0|-8.5|10.25||||||||10.25|-8.50|
70902945|NCT00445679|141293654|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority to paroxetine was declared if the lower limit of the 95% two-sided confidence interval for the difference in responders is greater than or equal to -9 percentage points.|Difference|-2.17|||||TWO_SIDED|95.0|-11.68|7.33||||||||7.33|-11.68|
70902946|NCT00445679|141293655|SUPERIORITY_OR_OTHER|||||||0.714||95.0|||||Cochran-Mantel-Haenszel|||Final on-therapy population||||0.714
70902947|NCT00445679|141293655|SUPERIORITY_OR_OTHER|||||||0.653||95.0|||||Cochran-Mantel-Haenszel|||Final on-therapy population||||0.653
70902948|NCT00445679|141293655|SUPERIORITY_OR_OTHER|||||||0.881||95.0|||||Cochran-Mantel-Haenszel|||Final on-therapy population||||0.881
70902949|NCT00445679|141293656|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||Cochran-Mantel-Haenszel|||Final on-therapy population||||0.450
70902950|NCT00445679|141293656|SUPERIORITY_OR_OTHER|||||||0.452||95.0|||||Cochran-Mantel-Haenszel|||Final on-therapy population||||0.452
70902951|NCT00445679|141293656|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Cochran-Mantel-Haenszel|||Final on-therapy population||||0.850
70902952|NCT01806584|141293690|SUPERIORITY_OR_OTHER_LEGACY|||||||0.138|TWO_SIDED|||||p-value based on log rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||Analysis of time to loss of patency||||0.138
70902953|NCT01806584|141293691|SUPERIORITY_OR_OTHER_LEGACY|||||||0.312|TWO_SIDED|||||p-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||Analysis of time to loss of patency||||0.312
70902954|NCT01806584|141293692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.093|TWO_SIDED|||||p-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||Analysis of time to loss of patency||||0.093
70902955|NCT01806584|141293693|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|0.23|||||TWO_SIDED|95.0|-0.942|1.402||||||||1.402|-0.942|
70902956|NCT03021668|141293694|EQUIVALENCE|Chi2 test was performed to analyze difference in rates of Surgical Site Infections (SSIs) between the two groups||||||0.003|||||||Chi-squared|||||||0.003
70902957|NCT03021668|141293695|EQUIVALENCE|Students' T-test was used to evaluate any difference in length of stay between the two groups.||||||0.23|||||||t-test, 2 sided|||||||0.23
70902958|NCT00909428|141293698|SUPERIORITY||Z-Score|2.803||||0.005|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no change from baseline maximal tolerated cystometric capacity following 30 days of treatment with daily 10mg solifenacin succinate.||||.005
70902959|NCT03445065|141293721|SUPERIORITY||Mean Difference (Net)|-0.1||||0.341|TWO_SIDED|95.0|-0.4|0.1||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The ANCOVA model included arm, centre, and type of diabetes as fixed classification effects, and HbA1c (%) at inclusion as baseline covariate.|The mean difference in HbA1c (%) at Day 180 was calculated as the Enabled group minus the Control group.|||0.1|-0.4|0.341
70902960|NCT03445065|141293722|SUPERIORITY||Mean Difference (Net)|-1.6||||0.03892|TWO_SIDED|95.0|-3.1|-0.1||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The ANCOVA model included arm and centre as fixed classification effects and % time in hypoglycemia (\<54mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||-0.1|-3.1|0.03892
70902961|NCT03445065|141293726|SUPERIORITY||Mean Difference (Net)|5.4||||0.056|TWO_SIDED|95.0|-0.1|10.9||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm, centre, and diabetes type as fixed classification effects, and % time in euglycemic range (Day0-30) as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||10.9|-0.1|0.056
70902962|NCT03445065|141293726|SUPERIORITY||Mean Difference (Net)|4.7||||0.01255|TWO_SIDED|95.0|1.0|8.4||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in euglycemic range (Day0-30) as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||8.4|1.0|0.01255
70902963|NCT03445065|141293727|SUPERIORITY||Mean Difference (Net)|-5.5||||0.015|TWO_SIDED|95.0|-9.9|-1.1||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hyperglycemia \>250mg/dL Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||-1.1|-9.9|0.015
70902964|NCT03445065|141293727|SUPERIORITY||Mean Difference (Net)|-1.0||||0.50266|TWO_SIDED|95.0|-4.0|2.0||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hyperglycemia (\>250mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||2.0|-4.0|0.50266
70902965|NCT03445065|141293728|SUPERIORITY||Mean Difference (Net)|-5.1||||0.08|TWO_SIDED|95.0|-10.9|0.6||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hyperglycemia \>180mg/dL Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.6|-10.9|0.080
70902966|NCT03445065|141293728|SUPERIORITY||Mean Difference (Net)|-3.3||||0.10637|TWO_SIDED|95.0|-7.3|0.7||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hyperglycemia (\>180mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.7|-7.3|0.10637
70902967|NCT03445065|141293729|SUPERIORITY||Mean Difference (Net)|-0.2||||0.671|TWO_SIDED|95.0|-1.2|0.7||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hypoglycemia (\<70mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.7|-1.2|0.671
70902968|NCT03445065|141293729|SUPERIORITY||Mean Difference (Net)|-1.8||||0.12935|TWO_SIDED|95.0|-4.1|0.5||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hypoglycemia (\<70mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.5|-4.1|0.12935
70902969|NCT03445065|141293730|SUPERIORITY||Mean Difference (Net)|-0.1||||0.693|TWO_SIDED|95.0|-0.6|0.4||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hypoglycemia (\<54mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.4|-0.6|0.693
70902970|NCT03445065|141293731|SUPERIORITY||Mean Difference (Net)|-0.9||||0.753|TWO_SIDED|95.0|-6.7|4.9||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in euglycemic range (Day0-30) as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||4.9|-6.7|0.753
70902971|NCT03445065|141293731|SUPERIORITY||Mean Difference (Net)|-0.4||||0.84307|TWO_SIDED|95.0|-4.6|3.8||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effect, and % time in euglycemic range (Day0-30) as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||3.8|-4.6|0.84307
70902972|NCT03445065|141293732|SUPERIORITY||Mean Difference (Net)|-0.9||||0.653|TWO_SIDED|95.0|-4.8|3.0||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hyperglycemia (\>250mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||3.0|-4.8|0.653
70902973|NCT03445065|141293732|SUPERIORITY||Mean Difference (Net)|2.3||||0.07261|TWO_SIDED|95.0|-0.2|4.8||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hyperglycemia (\>250mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||4.8|-0.2|0.07261
70902974|NCT03445065|141293733|SUPERIORITY||Mean Difference (Net)|1.3||||0.685|TWO_SIDED|95.0|-4.9|7.4||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hyperglycemia (\>180mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||7.4|-4.9|0.685
70902975|NCT03445065|141293733|SUPERIORITY||Mean Difference (Net)|3.1||||0.19785|TWO_SIDED|95.0|-1.6|7.8||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hyperglycemia (\>180mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||7.8|-1.6|0.19785
70902976|NCT03445065|141293734|SUPERIORITY||Mean Difference (Net)|-0.4||||0.549|TWO_SIDED|95.0|-1.5|0.8||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hypoglycemia (\<70mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.8|-1.5|0.549
70902977|NCT03445065|141293734|SUPERIORITY||Mean Difference (Net)|-3.3||||0.0318|TWO_SIDED|95.0|-6.3|-0.3||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hypoglycemia (\<70mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||-0.3|-6.3|0.03180
70902978|NCT03445065|141293735|SUPERIORITY||Mean Difference (Net)|0.1||||0.859|TWO_SIDED|95.0|-0.6|0.7||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hypoglycemia (\<54mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.7|-0.6|0.859
70902979|NCT03445065|141293735|SUPERIORITY||Mean Difference (Net)|-2.6||||0.01124|TWO_SIDED|95.0|-4.5|-0.6||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hypoglycemia (\<54mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||-0.6|-4.5|0.01124
70902980|NCT03445065|141293736|SUPERIORITY||Mean Difference (Net)|-0.802|STANDARD_ERROR_OF_MEAN|0.391||0.045|TWO_SIDED|95.0|-1.1585|-0.018||The significance level was set to p\<0.05 (two-sided).|Mixed Models Analysis|The model included time and centre as fixed classification effects and % time in hypoglycemia (\<54mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled (D150-180) group minus the Enabled (D90-120) group.|||-0.018|-1.1585|0.045
70902981|NCT03445065|141293737|SUPERIORITY||Mean Difference (Net)|0.47|STANDARD_ERROR_OF_MEAN|1.54||0.763|TWO_SIDED|95.0|-2.741|3.682||The significance level was set to p\<0.05 (two-sided).|Mixed Model for Repeated Measures|The model included time and centre as fixed classification effects and % time in hypoglycemia (\<54mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Switch to Enabled (D150-180) group minus the Control (D90-120) group.|||3.682|-2.741|0.763
70902982|NCT03445065|141293738|SUPERIORITY||Mean Difference (Net)|1.3||||0.14|TWO_SIDED|95.0|-0.4|3.0||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and glucose variability Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||3.0|-0.4|0.140
70902983|NCT03445065|141293738|SUPERIORITY||Mean Difference (Net)|-0.5||||0.6411|TWO_SIDED|95.0|-2.6|1.6||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and glucose variability Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||1.6|-2.6|0.64110
70902984|NCT03445065|141293739|SUPERIORITY||Mean Difference (Net)|1.0||||0.339|TWO_SIDED|95.0|-1.1|3.1||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and glucose variability Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||3.1|-1.1|0.339
70902985|NCT03445065|141293739|SUPERIORITY||Mean Difference (Net)|-0.7||||0.57677|TWO_SIDED|95.0|-3.0|1.7||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and glucose variability Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||1.7|-3.0|0.57677
70902986|NCT03445065|141293740|SUPERIORITY||Mean Difference (Net)|-0.1||||0.558|TWO_SIDED|95.0|-0.3|0.2||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm, centre, and diabetes type as fixed classification effects, and HbA1c (%) at inclusion as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.2|-0.3|0.558
70902987|NCT03445065|141293740|SUPERIORITY||Mean Difference (Net)|-0.1||||0.408|TWO_SIDED|95.0|-0.3|0.1||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and HbA1c (%) at inclusion as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.1|-0.3|0.408
70902988|NCT03445065|141293741|SUPERIORITY||Mean Difference (Net)|0.1||||0.616|TWO_SIDED|95.0|-0.2|0.4||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and HbA1c (%) at inclusion as baseline covariate.|The mean difference in HbA1c (%) at Day 180 was calculated as the Enabled group minus the Control group.|||0.4|-0.2|0.616
70902989|NCT03315130|141293762|SUPERIORITY||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.7|=|0.0941|TWO_SIDED|80.0|-4.5|-0.1||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-0.1|-4.5|=0.0941
70902990|NCT03315130|141293762|SUPERIORITY||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|1.7|=|0.0538|TWO_SIDED|80.0|-5.1|-0.6||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-0.6|-5.1|=0.0538
70902991|NCT03315130|141293763|SUPERIORITY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|1.3|=|0.047|TWO_SIDED|80.0|-3.9|-0.5||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-0.5|-3.9|=0.0470
70902992|NCT03315130|141293763|SUPERIORITY||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.3|=|0.0392|TWO_SIDED|80.0|-4.0|-0.6||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-0.6|-4.0|=0.0392
70902993|NCT03315130|141293764|SUPERIORITY||LS Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|2.4|=|0.017|TWO_SIDED|80.0|-8.4|-2.1||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-2.1|-8.4|=0.0170
70902994|NCT03315130|141293764|SUPERIORITY||LS Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|2.4|=|0.0624|TWO_SIDED|80.0|-6.9|-0.6||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-0.6|-6.9|=0.0624
70902995|NCT03315130|141293765|SUPERIORITY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.2|=|0.1866|TWO_SIDED|80.0|-4.9|0.9||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||0.9|-4.9|=0.1866
70902996|NCT03315130|141293765|SUPERIORITY||LS Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|2.2|=|0.0391|TWO_SIDED|80.0|-7.0|-1.1||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-1.1|-7.0|=0.0391
70902997|NCT03315130|141293769|SUPERIORITY||LS Mean Difference|-82.597|STANDARD_ERROR_OF_MEAN|3.563|<|0.0001|TWO_SIDED|80.0|-87.249|-77.946||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-77.946|-87.249|<0.0001
70902998|NCT03315130|141293769|SUPERIORITY||LS Mean Difference|-95.689|STANDARD_ERROR_OF_MEAN|3.91|<|0.0001|TWO_SIDED|80.0|-100.794|-90.585||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-90.585|-100.794|<0.0001
70902999|NCT03315130|141293770|SUPERIORITY||LS Mean Difference|60.123|STANDARD_ERROR_OF_MEAN|9.394|<|0.0001|TWO_SIDED|80.0|47.839|72.408||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||72.408|47.839|<0.0001
70903000|NCT03315130|141293770|SUPERIORITY||LS Mean Difference|57.076|STANDARD_ERROR_OF_MEAN|9.269|<|0.0001|TWO_SIDED|80.0|44.955|69.197||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||69.197|44.955|<0.0001
70903001|NCT02707692|141293775|SUPERIORITY||Mean Difference (Final Values)|-988.0||||0.32|TWO_SIDED|95.0|-2996.3|1020.3|||Paired t-test, 2 sided|||Primary hypothesis: Participants will have a higher absolute difference in levels of CD4+ T cell-associated HIV RNA transcription seven days after receiving either Pneumococcal or Influenza vaccinations, when compared to seven days after receiving placebo.||1020.3|-2996.3|0.32
70903002|NCT02707692|141293775|SUPERIORITY||Mean Difference (Final Values)|-405.0||||0.31|TWO_SIDED|95.0|-1199.7|389.7|||Paired t-test, 2 sided|||Primary hypothesis: Participants will have a higher absolute difference in levels of CD4+ T cell-associated HIV RNA transcription seven days after receiving either Pneumococcal or Influenza vaccinations, when compared to seven days after receiving placebo.||389.7|-1199.7|0.31
70903003|NCT03535337|141293777|SUPERIORITY||Slope|2.44|STANDARD_ERROR_OF_MEAN|1.1||0.03|TWO_SIDED|95.0|0.28|4.59|||Mixed Models Analysis|||||4.59|0.28|0.03
70903004|NCT03535337|141293778|SUPERIORITY||Slope|0.17|STANDARD_ERROR_OF_MEAN|0.76||0.82|TWO_SIDED|95.0|-1.32|1.66|||Mixed Models Analysis|||||1.66|-1.32|0.82
70903005|NCT03469284|141293784|OTHER|||||||0.0034|||||||ANOVA|||||||0.0034
70903006|NCT03469284|141293785|OTHER|||||||0.0008|||||||ANOVA|||||||0.0008
70903007|NCT03469284|141293787|OTHER|||||||0.9182|||||||Fisher Exact|||||||0.9182
70903008|NCT03469284|141293788|OTHER|||||||0.1046|||||||Fisher Exact|||||||0.1046
70903009|NCT02991482|141293798|SUPERIORITY|||||||0.76|||||||Log Rank|||||||0.76
70903010|NCT00871403|141293805|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.2647|TWO_SIDED|95.0|0.43|1.28|||Log Rank||The hazard ratios is estimated using a Pike estimator. The estimated value is the hazard ratio comparing Pazopanib 800 mg plus pemetrexed 500 mg/m\^2 to Cisplatin 75 mg/m\^2 plus pemetrexed 500 mg/m\^2.|||1.28|0.43|0.2647
70903011|NCT00871403|141293808|SUPERIORITY_OR_OTHER||percent difference in response|-12.0||||0.2113|TWO_SIDED|95.0|-30.6|7.2|||Binomial asymptotic||The estimated value is the percent difference in the response rate comparing Pazopanib 800 mg plus pemetrexed 500 mg/m\^2 to Cisplatin 75 mg/m\^2 plus pemetrexed 500 mg/m\^2.|||7.2|-30.6|0.2113
70903012|NCT02150837|141293845|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Within group comparison (for each group) using a non-parametric paired Wilcoxon signed rank test comparing repeated measures in a single sample.||||||<0.0001
70903013|NCT00659984|141293940|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.2||||0.363|TWO_SIDED|95.0|-3.4|13.9|||Cochran Armitage Trend Test|||||13.9|-3.4|0.363
70903014|NCT03541044|141293956|EQUIVALENCE|Bioequivalence was determined if the 90% CIs of the GMRs for AUC0-t fell completely within the 0.80 - 1.25 range.|Geometric mean ratio|0.95|||||TWO_SIDED|90.0|0.91|1.0|||||GMR= (Prototype mini Lozenge/ Nicorette mini Lozenge)|||1.00|0.91|
70903015|NCT03541044|141293957|EQUIVALENCE|Bioequivalence was determined if the 90% CIs of the GMRs for AUC(0-inf) fell completely within the 0.80 - 1.25 range.|Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.89|1.0|||||GMR = (Prototype mini Lozenge/Nicorette mini Lozenge)|||1.00|0.89|
70903016|NCT03541044|141293958|EQUIVALENCE|Bioequivalence was determined if the 90% CIs of the GMRs for Cmax fell completely within the 0.80 - 1.25 range.|Geometric Mean Ratio|0.89|||||TWO_SIDED|90.0|0.82|0.98|||||GMR = (Prototype mini Lozenge/Nicorette mini Lozenge)|||0.98|0.82|
70903017|NCT02424591|141293983|SUPERIORITY_OR_OTHER|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||||||0.86
70903018|NCT02424591|141293984|SUPERIORITY_OR_OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
70903019|NCT02424591|141293985|SUPERIORITY_OR_OTHER|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
70903020|NCT01453348|141293988|NON_INFERIORITY_OR_EQUIVALENCE|(GMC anti-HAV + MenACWY-CRM / GMC anti-HAV)|Ratio of GMC|0.89|||||TWO_SIDED|95.0|0.6|1.32||The testing was done by assessing the confidence interval of the ratio|ANCOVA|The Analysis of variance (ANCOVA) model included vaccine group and center as factors, age as covariate and was adjusted for baseline.||The primary criterion for immunogenicity was that the lower-limit of the two-sided 95% Confidence Interval (CI) on the ratio of Enzyme-linked Immunosorbent Assay (ELISA) GMCs (Hep A/B + MenACWY-CRM to Hep A/B) is below or equal to 0.5.||1.32|0.6|
70903021|NCT01453348|141293988|NON_INFERIORITY_OR_EQUIVALENCE|(GMC anti-HBsAg + MenACWY-CRM / GMC anti-HBsAg)|Ratio of GMC|1.19|||||TWO_SIDED|95.0|0.59|2.37||The testing was done by assessing the confidence interval of the ratio|ANCOVA|The ANCOVA model included vaccines group and center as factors, age as covariate and was adjusted for baseline.||The primary criterion for immunogenicity was that the the lower-limit of the two-sided 95% CI on the ratio of ELISA GMCs (Hep A/B + MenACWY-CRM to Hep A/B) is below or equal to 0.5.||2.37|0.59|
70903022|NCT01991821|141293996|SUPERIORITY|||||||0.093||||||The complete response of the primary efficacy analysis occurred in 95 patients (56.2%; 95% confidence interval \[CI\] 48.4 - 63.8%) in the APD421 group and 83 patients (46.6%; 95% CI 39.1- 54.2%) in the placebo group|Chi-squared, Corrected|Pearson square test with Yates's continuity correction and with the two- sided significance level of 5%||The primary efficacy analysis was a complete response which is defined as protection from PONV1, which was absence of any episode of emesis, significant nausea or use of rescue medication with the first 24 hours post-operatively.||||0.093
70903023|NCT01991821|141293997|SUPERIORITY|||||||0.059||||||Two-sided, significance threshold = 0.05|Chi-squared, Corrected|||||||0.059
70903024|NCT01991821|141293998|SUPERIORITY|||||||0.053||||||Two-sided, significance threshold = 0.05|Chi-squared, Corrected|||||||0.053
70903025|NCT01991821|141293999|SUPERIORITY|||||||0.26||||||Two-sided, significance threshold = 0.05|Chi-squared, Corrected|||||||0.26
70903026|NCT01991821|141294000|SUPERIORITY|||||||0.06||||||Two-sided, significance threshold = 0.05|Chi-squared, Corrected|||||||0.06
70903027|NCT01991821|141294001|SUPERIORITY|||||||0.079||||||Two-sided, significance threshold = 0.05|Chi-squared, Corrected|||||||0.079
70903028|NCT01991821|141294002|SUPERIORITY|||||||0.096|||||||Chi-squared, Corrected|||||||0.096
70903029|NCT04581200|141294003|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.61|TWO_SIDED|95.0|-1.63|2.8|||t-test, 2 sided|||||2.80|-1.63|0.61
70903030|NCT04581200|141294004|OTHER|This is an exploratory pilot trial|Mean Difference (Final Values)|0.21||||0.89|TWO_SIDED|95.0|-2.66|3.08|||t-test, 2 sided|||||3.08|-2.66|0.89
70903031|NCT04581200|141294005|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.81|TWO_SIDED|95.0|-2.58|3.3|||t-test, 2 sided|||||3.30|-2.58|0.81
70903032|NCT04581200|141294006|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.75|TWO_SIDED|95.0|-2.98|2.14|||t-test, 2 sided|||||2.14|-2.98|0.75
70903033|NCT04581200|141294007|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.45|TWO_SIDED|95.0|-0.57|0.74|||t-test, 2 sided|||||0.74|-0.57|0.45
70903034|NCT04581200|141294008|SUPERIORITY||Mean Difference (Final Values)|0.002||||0.98|TWO_SIDED|95.0|-0.13|0.13|||t-test, 2 sided|||||0.13|-0.13|0.98
70903035|NCT04581200|141294009|SUPERIORITY|||||||0.08|||||||Fisher Exact|||||||0.08
70903036|NCT04581200|141294010|SUPERIORITY|||||||0.69|||||||Fisher Exact|||||||0.69
70903037|NCT01462162|141294029|SUPERIORITY_OR_OTHER|||||||0.006|||||||Regression, Linear|||change in fatigue score versus change in DAS-28 score||||0.006
70903038|NCT01462162|141294029|SUPERIORITY_OR_OTHER|||||||0|||||||Regression, Linear|||change in fatigue score versus change in sleepiness score||||0.000
70903039|NCT01462162|141294029|SUPERIORITY_OR_OTHER|||||||0|||||||Regression, Linear|||change in fatigue score versus change in depression score||||0.000
70903040|NCT01462162|141294030|SUPERIORITY_OR_OTHER|||||||0.023|||||||Regression, Linear|||change in fatigue score versus change in DAS-28 score||||0.023
70903041|NCT01462162|141294030|SUPERIORITY_OR_OTHER|||||||0.007|||||||Regression, Linear|||change in fatigue score versus change in sleepiness score||||0.007
70903042|NCT01462162|141294030|SUPERIORITY_OR_OTHER|||||||0|||||||Regression, Linear|||change in fatigue score versus change in depression score||||0.000
70903043|NCT01462162|141294031|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline versus Week 12||||<0.001
70903044|NCT01462162|141294031|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline versus Week 24||||<0.001
70903045|NCT01462162|141294032|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
70903046|NCT01462162|141294032|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
70903047|NCT01462162|141294033|SUPERIORITY_OR_OTHER|||||||0.003|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in DAS-28 at Week 12||||0.003
70903048|NCT01462162|141294033|SUPERIORITY_OR_OTHER|||||||0.006|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in DAS-28 at Week 24||||0.006
70903049|NCT01462162|141294033|SUPERIORITY_OR_OTHER|||||||0.791|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in serum hemoglobin Week 12||||0.791
70903050|NCT01462162|141294033|SUPERIORITY_OR_OTHER|||||||0.847|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in serum hemoglobin Week 24||||0.847
70903051|NCT01462162|141294033|SUPERIORITY_OR_OTHER|||||||0.182|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in swollen joint count Week 12||||0.182
70903052|NCT01462162|141294033|SUPERIORITY_OR_OTHER|||||||0.022|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in swollen joint count Week 24||||0.022
70903053|NCT01462162|141294033|SUPERIORITY_OR_OTHER|||||||0.163|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in morning stiffness Week 12||||0.163
70903054|NCT01462162|141294033|SUPERIORITY_OR_OTHER|||||||0.115|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in morning stiffness Week 24||||0.115
70903055|NCT01462162|141294033|SUPERIORITY_OR_OTHER|||||||0.037|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in degree of pain Week 12||||0.037
70903056|NCT01462162|141294033|SUPERIORITY_OR_OTHER|||||||0.044|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in degree of pain Week 24||||0.044
70903057|NCT01462162|141294033|SUPERIORITY_OR_OTHER|||||||0.003|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in sleepiness at Week 12||||0.003
70903058|NCT01462162|141294033|SUPERIORITY_OR_OTHER|||||||0.001|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in sleepiness at Week 24||||0.001
70903059|NCT01462162|141294033|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in depression Week 12||||<0.001
70903060|NCT01462162|141294033|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in depression at Week 24||||<0.001
70903061|NCT01462162|141294034|SUPERIORITY_OR_OTHER|||||||0.678|||||||Regression, Linear|||change in hemoglobin levels versus change in swollen joint count (Week 12)||||0.678
70903062|NCT01462162|141294034|SUPERIORITY_OR_OTHER|||||||0.348|||||||Regression, Linear|||change in hemoglobin levels versus change in swollen joint count (Week 24)||||0.348
70903063|NCT01462162|141294034|SUPERIORITY_OR_OTHER|||||||0.679|||||||Regression, Linear|||change in hemoglobin levels versus change in morning stiffness (Week 12)||||0.679
70903064|NCT01462162|141294034|SUPERIORITY_OR_OTHER|||||||0.556|||||||Regression, Linear|||change in hemoglobin levels versus change in morning stiffness (Week 24)||||0.556
70903065|NCT01462162|141294034|SUPERIORITY_OR_OTHER|||||||0.692|||||||Regression, Linear|||change in haemoglobin levels versus change in degree of pain (Week 12)||||0.692
70903066|NCT01462162|141294034|SUPERIORITY_OR_OTHER|||||||0.771|||||||Regression, Linear|||change in haemoglobin levels versus change in degree of pain (Week 24)||||0.771
70903067|NCT01462162|141294034|SUPERIORITY_OR_OTHER|||||||0.878|||||||Regression, Linear|||change in haemoglobin levels versus change in sleepiness (Week 12)||||0.878
70903068|NCT01462162|141294034|SUPERIORITY_OR_OTHER|||||||0.139|||||||Regression, Linear|||change in haemoglobin levels versus change in sleepiness (Week 24)||||0.139
70903069|NCT01462162|141294034|SUPERIORITY_OR_OTHER|||||||0.249|||||||Regression, Linear|||change in haemoglobin levels versus change in depression score (Week 12)||||0.249
70903070|NCT01462162|141294034|SUPERIORITY_OR_OTHER|||||||0.61|||||||Regression, Linear|||change in hemoglobin levels versus change in depression score (Week 24)||||0.610
70903071|NCT01462162|141294035|SUPERIORITY_OR_OTHER|||||||0.257|||||||Regression, Linear|||change in haemoglobin levels versus change in swollen joint count (Week 12)||||0.257
70903072|NCT01462162|141294035|SUPERIORITY_OR_OTHER|||||||0.487|||||||Regression, Linear|||change in haemoglobin levels versus change in swollen joint count (Week 24)||||0.487
70903073|NCT01462162|141294035|SUPERIORITY_OR_OTHER|||||||0.644|||||||Regression, Linear|||change in hemoglobin levels versus change in morning stiffness (Week 12)||||0.644
70903074|NCT01462162|141294035|SUPERIORITY_OR_OTHER|||||||0.498|||||||Regression, Linear|||change in hemoglobin levels versus change in morning stiffness (Week 24)||||0.498
70903075|NCT01462162|141294035|SUPERIORITY_OR_OTHER|||||||0.65|||||||Regression, Linear|||change in hemoglobin levels versus change in degree of pain (Week 12)||||0.650
70903076|NCT01462162|141294035|SUPERIORITY_OR_OTHER|||||||0.75|||||||Regression, Cox|||change in hemoglobin levels versus change in degree of pain (Week 24)||||0.750
70903077|NCT01462162|141294035|SUPERIORITY_OR_OTHER|||||||0.936|||||||Regression, Linear|||change in hemoglobin levels versus change in sleepiness (Week 12)||||0.936
70903078|NCT01462162|141294035|SUPERIORITY_OR_OTHER|||||||0.075|||||||Regression, Linear|||change in hemoglobin levels versus change in sleepiness (Week 24)||||0.075
70903079|NCT01462162|141294035|SUPERIORITY_OR_OTHER|||||||0.098|||||||Regression, Linear|||change in hemoglobin levels versus change in depression score (Week 12)||||0.098
70903080|NCT01462162|141294035|SUPERIORITY_OR_OTHER|||||||0.09|||||||Regression, Linear|||change in hemoglobin levels versus change in depression score (Week 24)||||0.090
70903081|NCT01462162|141294036|SUPERIORITY_OR_OTHER|||||||0.077|||||||Multiple Regression|||change in hemoglobin levels versus change in swollen joint count (Week 12)||||0.077
70903082|NCT01462162|141294036|SUPERIORITY_OR_OTHER|||||||0.961|||||||Multiple Regression|||change in hemoglobin levels versus change in swollen joint count (Week 24)||||0.961
70903083|NCT01462162|141294037|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
70903084|NCT01462162|141294037|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
70903085|NCT01462162|141294038|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
70903086|NCT01462162|141294038|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
70903087|NCT01462162|141294039|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
70903088|NCT01462162|141294039|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
70903089|NCT01462162|141294040|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
70903090|NCT01462162|141294040|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
70903091|NCT01462162|141294041|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
70903092|NCT01462162|141294041|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
70903093|NCT01462162|141294042|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
70903094|NCT01462162|141294042|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
70903095|NCT01462162|141294043|SUPERIORITY_OR_OTHER|||||||0.172|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||0.172
70903096|NCT01462162|141294043|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Regression, Logistic|||Baseline for Week 24 versus Week 24||||<0.05
70903097|NCT01462162|141294044|SUPERIORITY_OR_OTHER|||||||0.162|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||0.162
70903098|NCT01462162|141294044|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 24||||<0.001
70903099|NCT01462162|141294045|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
70903100|NCT01462162|141294045|SUPERIORITY_OR_OTHER||||||<|0.005|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.005
70903101|NCT01462162|141294046|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
70903102|NCT01462162|141294046|SUPERIORITY_OR_OTHER||||||<|0.005|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.005
70903103|NCT01462162|141294047|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
70903104|NCT01462162|141294047|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
70903105|NCT03485911|141294051|SUPERIORITY||negative binomial regression model|30.0||||0.024|TWO_SIDED|95.0|4.6|48.7|||negative binomial regression model|||||48.7|4.6|0.024
70903106|NCT03485911|141294051|SUPERIORITY||negative binomial regression model|44.2|||<|0.001|TWO_SIDED|95.0|23.0|59.5|||negative binomial regression model|||||59.5|23.0|<0.001
70903107|NCT03485911|141294053|SUPERIORITY||Mean Difference (Final Values)|-2.77||||0.453|TWO_SIDED|95.0|-10.08|4.53|||mixed-model repeated measures analysis|||Numerical difference in change from baseline of AE-QoL total score between treatment groups.||4.53|-10.08|0.453
70903108|NCT03485911|141294053|SUPERIORITY||Mean Difference (Final Values)|-4.9||||0.188|TWO_SIDED|95.0|-12.23|2.43|||mixed-model repeated measures analysis|||Numerical difference in change from baseline of AE-QoL total score between treatment groups.||2.43|-12.23|0.188
70903109|NCT03485911|141294054|SUPERIORITY||Difference in Least Square Means|-0.062||||0.025|TWO_SIDED|95.0|-0.117|-0.008|||ANCOVA|||Numerical differences from the placebo treatment in the LSM proportion of the 169 days of treatment with angioedema symptoms. In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the second secondary endpoint of proportion of days with angioedema symptoms through 24 weeks for statistical significance would not be completed. P-values that are reported are nominal.||-0.008|-0.117|0.025
70903110|NCT03485911|141294054|SUPERIORITY||Difference in Least Square Means|-0.078||||0.006|TWO_SIDED|95.0|-0.133|-0.023|||ANCOVA|||Numerical differences from the placebo treatment in the LSM proportion of the 169 days of treatment with angioedema symptoms. In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the second secondary endpoint of number and proportion of days with angioedema symptoms through 24 weeks for statistical significance would not be completed. P-values that are reported are nominal.||-0.023|-0.133|0.006
70903111|NCT03485911|141294055|SUPERIORITY||negative binomial regression model|30.4||||0.026|TWO_SIDED|95.0|4.3|49.3|||negative binomial regression model|||In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the third secondary endpoint of rate of expert-confirmed HAE attacks during dosing in the effective treatment period for statistical significance would not be completed. P-values reported are nominal.||49.3|4.3|0.026
70903112|NCT03485911|141294055|SUPERIORITY||negative binomial regression model|46.5|||<|0.001|TWO_SIDED|95.0|25.6|61.5|||negative binomial regression model|||In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the third secondary endpoint of rate of expert-confirmed HAE attacks during dosing in the effective treatment period for statistical significance would not be completed. P-values reported are nominal.||61.5|25.6|<0.001
70903113|NCT00909480|141294059|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin: 0.4%.|Mean Difference (Net)|0.3003||||||95.0|0.1427|0.458|||ANCOVA|Full analysis set, Model adjusted for: HbA1c at baseline, previous oral anti-diabetic treatment and country.||||0.4580|0.1427|
70903114|NCT00861601|141294078|SUPERIORITY_OR_OTHER|||||||0.0104||95.0||||Linearity. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.||||||0.0104
70903115|NCT00861601|141294078|SUPERIORITY_OR_OTHER|||||||0.0057||95.0||||Saturation at the medium dose. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.||||||0.0057
70903116|NCT00861601|141294078|SUPERIORITY_OR_OTHER|||||||0.0808||95.0||||Onset of response at the higher dose. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.||||||0.0808
70903117|NCT00861601|141294079|SUPERIORITY_OR_OTHER|||||||0.0116||95.0||||Linearity. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.||||||0.0116
70903118|NCT00861601|141294079|SUPERIORITY_OR_OTHER|||||||0.0066||95.0||||Saturation at the medium dose. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.||||||0.0066
70903119|NCT00861601|141294079|SUPERIORITY_OR_OTHER|||||||0.0846||95.0||||Onset of response at the higher dose. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.||||||0.0846
70903120|NCT05266963|141294096|SUPERIORITY|Statistical analysis will be performed using a paired samples Wilcoxon test to compare differences between the two groups.||||||0.43|||||||Wilcoxon (Mann-Whitney)|Wilcoxon matched-pairs||||||0.43
70903121|NCT05266963|141294097|SUPERIORITY|Statistical analysis will be performed using a standard two-tailed t test to compare differences between the two groups.||||||0.52|||||||t-test, 2 sided|||||||0.52
70903122|NCT05454410|141294156|SUPERIORITY||Mean Difference (Net)|-5.2|||||TWO_SIDED|90.0|-9.6|-0.7|||ANCOVA||Placebo adjusted means (MIJ821-Placebo). 90% CIs are nominal and not adjusted for multiplicity.|||-0.7|-9.6|
70903123|NCT05454410|141294156|SUPERIORITY||Mean Difference (Net)|-2.5|||||TWO_SIDED|90.0|-7.0|2.1|||ANCOVA||Placebo adjusted means (MIJ821-Placebo). 90% CIs are nominal and not adjusted for multiplicity.|||2.1|-7.0|
70903124|NCT05454410|141294156|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|90.0|-4.0|5.1|||ANCOVA||Placebo adjusted means (MIJ821-Placebo). 90% CIs are nominal and not adjusted for multiplicity.|||5.1|-4.0|
70903125|NCT05454410|141294162|SUPERIORITY|||||||0.0242||||||P-value for the selected model best representing the underlying DR (the lowest p-value out of the 6 candidate models), adjusted for multiple comparisons.|Multiple contrast test|||MCP-Mod was used to check if there was a DR relationship between the change from baseline to 24 hours in MADRS total score and the doses received. The Least squares means under the primary estimand were used to test the null hypothesis of a flat DR relationship at a one-sided significance level of 5% against the alternative hypothesis of a non-flat DR curve. Six candidate DR curves were used to derive the optimal model contrasts for the multiple contrast tests. A monotone DR was assumed.||||0.0242
70903126|NCT01395823|141294210|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Mixed Models Analysis|||||||0.78
70903127|NCT05076149|141294211|NON_INFERIORITY|The non-inferiority margin represents a clinically acceptable loss of effectiveness that margin preserve at least 50% of the treatment effect of the active control (ELX/TEZ/IVA) compared to placebo, where the treatment effect is estimated by the lower bound of the 95% confidence interval (CI)|LS Mean difference|0.2|||<|0.0001|TWO_SIDED|95.0|-0.5|0.9|||Mixed Models Repeated Measures|||||0.9|-0.5|< 0.0001
70903128|NCT05076149|141294212|SUPERIORITY||LS Mean difference|-2.8|||=|0.0034|TWO_SIDED|95.0|-4.7|-0.9|||Mixed Models Repeated Measures|||||-0.9|-4.7|=0.0034
70903129|NCT05076149|141294213|OTHER||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.55|3.16|||Generalized Estimated Equation Model|||||3.16|1.55|< 0.0001
70903130|NCT05076149|141294214|OTHER||Odds Ratio (OR)|2.87|||<|0.0001|TWO_SIDED|95.0|2.0|4.12|||Generalized Estimated Equation Model|||||4.12|2.00|< 0.0001
70903131|NCT00717314|141294215|SUPERIORITY_OR_OTHER|||||||0.494|||||||ANOVA|||||||0.494
70903132|NCT00717314|141294218|SUPERIORITY_OR_OTHER|||||||0.374|||||||ANOVA|||Between group comparison at Baseline||||0.374
70903133|NCT00717314|141294218|SUPERIORITY_OR_OTHER|||||||0.685||||||Analysis of covariance (ANCOVA) model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.|ANCOVA|||Change from Baseline at Week 16||||0.685
70903134|NCT00717314|141294218|SUPERIORITY_OR_OTHER|||||||0.722||||||ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.|ANCOVA|||Change from Baseline at Week 28||||0.722
70903135|NCT00717314|141294218|SUPERIORITY_OR_OTHER|||||||0.432||||||ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.|ANCOVA|||Change from Baseline at Week 40||||0.432
70903136|NCT00717314|141294219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-5.342|5.561||||||||5.561|-5.342|
70903137|NCT00717314|141294220|SUPERIORITY_OR_OTHER|||||||0.616||||||ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.|ANCOVA|||Change from Baseline at Week 16||||0.616
70903138|NCT00717314|141294220|SUPERIORITY_OR_OTHER|||||||0.334||||||ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.|ANCOVA|||Change from Baseline at Week 28||||0.334
70903139|NCT00717314|141294220|SUPERIORITY_OR_OTHER|||||||0.267||||||ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.|ANCOVA|||Change from Baseline at Week 40||||0.267
70903140|NCT00717314|141294220|SUPERIORITY_OR_OTHER|||||||0.764|||||||ANCOVA|ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.||Change from Baseline at Week 52||||0.764
70903141|NCT00717314|141294221|SUPERIORITY_OR_OTHER|||||||1|||||||ANCOVA|||||||1.000
70903142|NCT02087501|141294222|OTHER||Sample proportion|0.0|||||TWO_SIDED|95.0|0.0|11.6|||||The CI is calculated based on Clopper-Pearson method|||11.6|0|
70903143|NCT02087501|141294222|OTHER||Sample proportion|0.0|||||TWO_SIDED|95.0|0.0|11.6||||||||11.6|0|
70903144|NCT02087501|141294223|OTHER||Sample proportion|100.0|||||TWO_SIDED|95.0|88.4|100.0|||||CI is calculated based on Clopper-Pearson method|||100|88.4|
70903145|NCT02087501|141294224|OTHER||Sample proportion|80.0|||||TWO_SIDED|95.0|61.0|92.0||||||||92|61|
70903146|NCT00094328|141294231|OTHER|One sample t-test|Mean Difference (Final Values)|-1.62||||0.278|TWO_SIDED|95.0|-4.72|1.48|||t-test, 2 sided|||The primary efficacy parameter, change in growth rate (cm/year) after 12 months relative to the baseline growth rate was analysed using a one sample t-test. A 95% 2-sided confidence interval was calculated for the mean change in growth rate.||1.48|-4.72|0.278
70903147|NCT00094328|141294232|OTHER|One sample t-test|Median Difference (Final Values)|-0.07||||0.882|TWO_SIDED|95.0|-1.15|1.0|||t-test, 2 sided|||The primary efficacy parameter, change in growth rate (SD units) after 12 months relative to the baseline growth rate was analysed using a one sample t-test. A 95% 2-sided confidence interval was calculated for the mean change in growth rate.||1.00|-1.15|0.882
70903148|NCT03682705|141294240|SUPERIORITY||LS Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|90.0|-2.03|-0.85|||t-test, 2 sided|||Mixed-Effect Model Repeated Measure (MMRM) analysis was conducted, testing the superiority of the combination of upadacitinib 15 mg and elsubrutinib 60 mg compared to placebo at Week 12. Data collected after a participant discontinued study drug was considered as missing. The mixed model included the categorical fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline DAS28 (CRP) measurement.||-0.85|-2.03|<0.001
70903149|NCT00085202|141294321|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8001||95.0|||||Log Rank|||||||0.8001
70903150|NCT00085202|141294321|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5195||95.0|||||Log Rank|||||||0.5195
70903151|NCT00085202|141294321|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7696||95.0|||||Log Rank|||||||0.7696
70903152|NCT00085202|141294322|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0206||95.0|||||Log Rank|||||||0.0206
70903153|NCT00085202|141294324|SUPERIORITY|||||||0.6231|||||||t-test, 2 sided|||Change over time||||0.6231
70903154|NCT00085202|141294324|SUPERIORITY|||||||0.572|||||||t-test, 2 sided|||Baseline||||0.5720
70903155|NCT00658138|141294332|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|No power calculation done - pilot study|Mean Difference (Final Values)|0.05||||0.05|||||||Wilcoxon (Mann-Whitney)|||Hypothesis was no difference between adhesives tested at one year. Restorations were scored using USPHS subjective clinical criteria.||||0.05
70903156|NCT00658138|141294332|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|No power calculation done - pilot study|percentage of Alpha values||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Null hypothesis is adhesives are not different in clinical performance at one year||||>0.05
70903157|NCT01353222|141294351|SUPERIORITY||Hazard Ratio (HR)|1.141||||0.6188|TWO_SIDED|95.0|0.679|1.918|||From a stratified log-rank test, stratif||Cox regression model with treatment as the independent variable, stratified by randomization strata. Hazard ratio with control as reference.|||1.918|0.679|0.6188
70903158|NCT00116844|141294352|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Nonparametric tests-Wilcoxon Rank Sum|||||||<0.001
70903159|NCT00116844|141294353|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Nonparametric tests-Wilcoxon Rank Sum|||||||<0.001
70903160|NCT00116844|141294354|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Prescott's method|||||||<0.001
70903161|NCT00116844|141294355|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Nonparametric tests-Wilcoxon Rank Sum|||||||0.800
70903162|NCT00116844|141294356|SUPERIORITY_OR_OTHER|||||||0.229||95.0|||||Nonparametric tests-Wilcoxon Rank Sum|||||||0.229
70903163|NCT00116844|141294357|SUPERIORITY_OR_OTHER|||||||0.0331||95.0|||||Prescott's method|||||||0.0331
70903164|NCT03621202|141294373|OTHER||||||||||||||||||The EBBMS sensitivity was 100%.|||
70903165|NCT03621202|141294374|OTHER||||||||||||||||||The EBBMS specificity was 75%.|||
70903166|NCT02202434|141294377|NON_INFERIORITY|10.5% non-inferiority margin|Difference in Percentages|3.1||||0.0027|ONE_SIDED|97.5||8.32|||Farrington-Manning|||||8.32||0.0027
70903167|NCT02202434|141294378|NON_INFERIORITY|9.5% Non-Inferiority margin|Difference in Percentages|-10.1|||<|0.0001|ONE_SIDED|97.5||-4.41|||Farrington-Manning|||||-4.41||<0.0001
70903168|NCT02202434|141294378|SUPERIORITY||Difference in Percentages|-10.2||||0.0006|TWO_SIDED|95.0|-16.3|-4.0|||Chi-squared|||"Superiority analysis was only to be run if the non-inferiority analysis was met.~Superiority analysis was run on Intent to Treat Population."||-4.0|-16.3|0.0006
70903169|NCT02202434|141294379|SUPERIORITY||Difference in Percentages|-6.1|||<|0.0001|TWO_SIDED|95.0|-9.6|-2.6|||Chi-squared|||||-2.6|-9.6|<0.0001
70903170|NCT02714868|141294430|OTHER|||||||0.05|||||||t-test, 2 sided|||For goal attainment, we calculated independent t-tests to compare GAS t-scores across groups at outcome. Lowest score is 0, highest score is 100. 100 is highest goal attainment.||||.05
70903171|NCT03097861|141294490|OTHER|Treatment p-value is from ANCOVA using SBM count as dependent variable, treatment as fixed effect and baseline count as random effect|||||=|0.002|||||||ANCOVA|||||||=0.0020
70903172|NCT03097861|141294490|OTHER||||||<|0.0001|||||||ANCOVA|||Treatment p-value is from ANCOVA using SBM count as dependent variable, treatment as fixed effect and baseline count as random effect||||<0.0001
70903173|NCT03592277|141294514|SUPERIORITY|||||||0.344|||||||Chi-squared|||||||0.344
70903174|NCT03592277|141294515|SUPERIORITY|||||||0.526|||||||Chi-squared|||||||0.526
70903175|NCT03592277|141294516|SUPERIORITY|||||||0.123|||||||Chi-squared|||||||0.123
70903176|NCT03592277|141294517|SUPERIORITY|||||||0.66|||||||Fisher Exact|||||||0.660
70903177|NCT03592277|141294518|SUPERIORITY|||||||0.745|||||||t-test, 2 sided|||||||0.745
70903178|NCT03592277|141294519|SUPERIORITY|||||||0.236|||||||Chi-squared|||||||0.236
70903179|NCT05436912|141294538|OTHER||Geometric Mean Ratio|168.9||||0.3601|TWO_SIDED|90.0|61.3|465.3|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||465.3|61.3|0.3601
70903180|NCT05436912|141294538|OTHER||Geometric Mean Ratio|92.2||||0.9146|TWO_SIDED|90.0|23.0|368.9|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||368.9|23.0|0.9146
70903181|NCT05436912|141294538|OTHER||Geometric Mean Ratio|119.6||||0.7478|TWO_SIDED|90.0|43.4|329.3|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||329.3|43.4|0.7478
70903182|NCT05436912|141294540|OTHER||Geometric Mean Ratio|126.1||||0.4279|TWO_SIDED|90.0|74.8|212.8|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||212.8|74.8|0.4279
70903183|NCT05436912|141294540|OTHER||Geometric Mean Ratio|92.4||||0.8341|TWO_SIDED|90.0|46.4|183.9|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||183.9|46.4|0.8341
70903184|NCT05436912|141294540|OTHER||Geometric Mean Ratio|169.1||||0.1159|TWO_SIDED|90.0|97.1|294.6|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||294.6|97.1|0.1159
70903185|NCT05436912|141294541|OTHER||Geometric Mean Ratio|126.0||||0.4289|TWO_SIDED|90.0|74.8|212.4|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||212.4|74.8|0.4289
70903186|NCT05436912|141294541|OTHER||Geometric Mean Ratio|92.3||||0.8322|TWO_SIDED|90.0|46.5|183.3|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||183.3|46.5|0.8322
70903187|NCT05436912|141294541|OTHER||Geometric Mean Ratio|169.6||||0.1131|TWO_SIDED|90.0|97.6|294.6|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||294.6|97.6|0.1131
70903188|NCT03885011|141294549|SUPERIORITY||Odds Ratio (OR)|1.103||||0.8445|TWO_SIDED|95.0|0.413|2.949|||Regression, Logistic|||This analysis relates to Day 8 up to when pilocarpine HCl 0.2% either in CSF-1-FDC or as pilocarpine alone was administered for one week.||2.949|0.413|0.8445
70903189|NCT03885011|141294549|SUPERIORITY||Odds Ratio (OR)|1.646||||0.266|TWO_SIDED|95.0|0.684|3.958|||Regression, Logistic|||||3.958|0.684|0.2660
70903190|NCT03885011|141294550|SUPERIORITY||Odds Ratio (OR)|3.664||||0.0015|TWO_SIDED|95.0|1.646|8.154|||Regression, Logistic|||||8.154|1.646|0.0015
70903191|NCT03885011|141294550|SUPERIORITY||Odds Ratio (OR)|4.745||||0.0002|TWO_SIDED|95.0|2.088|10.786|||Regression, Logistic|||||10.786|2.088|0.0002
70903192|NCT03885011|141294551|SUPERIORITY|||||||0.1145|||||||Chi-squared|||||||0.1145
70903193|NCT03885011|141294551|SUPERIORITY|||||||0.0616|||||||Chi-squared|||||||0.0616
70903194|NCT03885011|141294552|SUPERIORITY|||||||0.0074|||||||Chi-squared|||||||0.0074
70903195|NCT03885011|141294552|SUPERIORITY|||||||0.0001|||||||Chi-squared|||||||0.0001
70903196|NCT01725386|141294578|SUPERIORITY_OR_OTHER|||||||0.895|||||||Log Rank (Mantel-Cox)|||||||0.895
70903197|NCT00098254|141294680|SUPERIORITY_OR_OTHER|||||||0.0027||95.0|||||Kaplan-Meier|||||||0.0027
70903198|NCT00098254|141294682|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||Kaplan-Meier|||||||0.33
70903199|NCT00098254|141294683|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||Kaplan-Meier|||||||0.042
70903200|NCT00098254|141294684|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Kaplan-Meier|||||||0.028
70903201|NCT04146896|141294691|SUPERIORITY|||||||0.704|||||||t-test, 2 sided|||||||0.704
70903202|NCT04146896|141294692|SUPERIORITY|||||||0.684|||||||t-test, 2 sided|||||||.684
70903203|NCT04146896|141294693|SUPERIORITY|||||||0.743|||||||t-test, 2 sided|||||||0.743
70903204|NCT04146896|141294694|SUPERIORITY|||||||0.483|||||||t-test, 2 sided|||||||.483
70903205|NCT04146896|141294695|SUPERIORITY|||||||0.199|||||||t-test, 2 sided|||||||.199
70903206|NCT04146896|141294696|SUPERIORITY|||||||0.273|||||||t-test, 2 sided|||||||.273
70903207|NCT04146896|141294697|SUPERIORITY|||||||0.668|||||||t-test, 2 sided|||||||.668
70903208|NCT02118337|141294702|SUPERIORITY||Rate difference|-23.8||||0.5494|TWO_SIDED|95.0|-72.8|31.1|||Fisher Exact|||||31.1|-72.8|0.5494
70903209|NCT02118337|141294702|SUPERIORITY||Rate difference|-7.1||||0.513|TWO_SIDED|95.0|-33.6|20.0|||Fisher Exact|||||20.0|-33.6|0.5130
70903210|NCT01515189|141294736|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.04|TWO_SIDED|95.0|0.7|0.99||Analysis stratified by ECOG performance status (0 vs. 1), prior treatment for metastatic melanoma (yes vs. no) and M-stage (M0/M1a/M1b vs. M1c without brain metastases vs. M1c with brain metastases).|Log Rank||Hazard of 10 mg/kg ipilimumab over hazard of 3 mg/kg, with 2-sided 95% confidence intervals are based on a Cox proportional hazards model|||0.99|0.70|0.0400
70903211|NCT01515189|141294737|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.1548|TWO_SIDED|95.0|0.76|1.04||Analysis stratified by ECOG performance status (0 vs. 1), prior treatment for metastatic melanoma (yes vs. no) and M-stage (M0/M1a/M1b vs. M1c without brain metastases vs. M1c with brain metastases).|Log Rank||Hazard of 10 mg/kg ipilimumab over hazard of 3 mg/kg, with 2-sided 95% confidence intervals are based on a Cox proportional hazards model|||1.04|0.76|0.1548
70903212|NCT01515189|141294743|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.49|1.04|||||Hazard of 10 mg/kg ipilimumab over hazard of 3 mg/kg. Based on an unstratified Cox proportional hazards model for subset of participants with brain metastases.|||1.04|0.49|
70903213|NCT03857230|141294775|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline AUC0-192 were used to assess bioequivalence between Primapur and Gonal-F (bioequivalence range of 80.00% to 125.00%)|Geometric Mean Ratio (%)|93.31||||0.05|TWO_SIDED|90.0|87.25|99.79|||ANOVA|||Statistical comparison of the obtained results comprised the calculation of parametric bilateral 90 % CIs for the ratios of the corresponding mean values of the pharmacokinetic parameters of the study and comparator drug. The equivalence of the pharmacokinetics of the drug products will be proven if the limits of the evaluated CIs for the ratios of the mean values are in the range of 80.00-125.00%.||99.79|87.25|0.05
70903214|NCT03857230|141294776|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline Cmax were used to assess bioequivalence between Primapur and Gonal-F (bioequivalence range of 80.00% to 125.00%)|Geometric Mean Ratio (%)|87.93||||0.05|TWO_SIDED|90.0|82.85|93.33|||ANOVA|||||93.33|82.85|0.05
70903215|NCT01933880|141294807|SUPERIORITY_OR_OTHER|||||||0.0387|||||||Signed Rank Sum Test|||P-value was calculated to compare the data at Baseline and change at Week 12 for the OROS-MPH group||||0.0387
70903216|NCT01933880|141294808|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||P-value was calculated to compare the data at Baseline and change at Week 1 for the OROS-MPH group||||<0.0001
70903217|NCT01933880|141294809|SUPERIORITY_OR_OTHER|||||||0.0001|||||||t-test, 2 sided|||P-value was calculated to compare the data at Baseline and change at Week 2 for the OROS-MPH group||||0.0001
70903218|NCT01933880|141294810|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||P-value was calculated to compare the data at Baseline and change at Week 3 for the OROS-MPH group||||<0.0001
70903219|NCT01933880|141294811|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||P-value was calculated to compare the data at Baseline and change at Week 7 for the OROS-MPH group||||<0.0001
70903220|NCT01933880|141294812|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||P-value was calculated to compare the data at Baseline and change at Week 12 for the OROS-MPH group||||<0.0001
70903221|NCT02395133|141294836|SUPERIORITY||Percent Change Difference|-14.83|||=|0.0001|TWO_SIDED|95.0|-22.34|-7.33|||ANCOVA|Threshold for significance at 0.05 level.||A 2-sided hierarchical testing procedure was used for the co-primary and key secondary efficacy endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Analysis was performed using ANCOVA method.||-7.33|-22.34|= 0.0001
70903222|NCT02395133|141294836|SUPERIORITY||Percent Change Difference|-17.83|||<|0.0001|TWO_SIDED|95.0|-25.33|-10.34|||ANCOVA|Threshold for significance at 0.05 level.||A 2-sided hierarchical testing procedure was used for the co-primary and key secondary efficacy endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Analysis was performed using ANCOVA method.||-10.34|-25.33|< 0.0001
70903223|NCT02395133|141294836|SUPERIORITY||Percent Change Difference|-21.61|||<|0.0001|TWO_SIDED|95.0|-28.36|-14.87|||ANCOVA|Threshold for significance at 0.05 level.||A 2-sided hierarchical testing procedure was used for the co-primary and key secondary efficacy endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Analysis was performed using ANCOVA method.||-14.87|-28.36|<0.0001
70903224|NCT02395133|141294837|SUPERIORITY||Percentage difference|24.5|||=|0.004|TWO_SIDED|95.0|9.7|39.29||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||39.29|9.70|= 0.0040
70903225|NCT02395133|141294837|SUPERIORITY||Percentage difference|28.0|||=|0.0004|TWO_SIDED|95.0|13.32|42.58||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||42.58|13.32|= 0.0004
70903226|NCT02395133|141294837|SUPERIORITY||Percentage difference|41.2|||<|0.0001|TWO_SIDED|95.0|28.93|53.52||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||53.52|28.93|<0.0001
70903227|NCT02395133|141294838|SUPERIORITY||Percentage difference|21.4|||=|0.013|TWO_SIDED|95.0|4.86|38.0||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||38.00|4.86|= 0.0130
70903228|NCT02395133|141294838|SUPERIORITY||Percentage difference|33.5|||=|0.0003|TWO_SIDED|95.0|17.38|49.72||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||49.72|17.38|= 0.0003
70903229|NCT02395133|141294838|SUPERIORITY||Percentage difference|42.1|||<|0.0001|TWO_SIDED|95.0|28.36|55.76||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||55.76|28.36|<0.0001
70903230|NCT02395133|141294839|SUPERIORITY||Percentage difference|18.5|||=|0.0209|TWO_SIDED|95.0|4.14|32.91||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||32.91|4.14|= 0.0209
70903231|NCT02395133|141294839|SUPERIORITY||Percentage difference|29.7|||=|0.0007|TWO_SIDED|95.0|14.89|44.42||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||44.42|14.89|= 0.0007
70903232|NCT02395133|141294839|SUPERIORITY||Percentage difference|39.7|||<|0.0001|TWO_SIDED|95.0|27.42|51.95||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||51.95|27.42|<0.0001
70903233|NCT02395133|141294840|SUPERIORITY||Percentage difference|-14.4||||0.1048|TWO_SIDED|95.0|-29.21|0.32||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||0.32|-29.21|0.1048
70903234|NCT02395133|141294840|SUPERIORITY||Percentage difference|-20.6|||=|0.0107|TWO_SIDED|95.0|-35.32|-5.89||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||-5.89|-35.32|= 0.0107
70903235|NCT02395133|141294840|SUPERIORITY||Percentage difference|-36.1|||<|0.0001|TWO_SIDED|95.0|-48.4|-23.74||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||-23.74|-48.40|<0.0001
70963642|NCT02273726|141432211|SUPERIORITY|Superiority was declared if the upper bound of the 2-sided 95% CI of the difference between roxadustat and epoetin alfa (roxadustat - epoetin alpha) was less than 0.|LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.739||0.35|TWO_SIDED|95.0|-0.76|2.142|||Mixed Models Analysis|||Treatment comparison was made using MMRM with baseline as a covariate, and treatment, visit, visit-by-treatment interaction, ESA dependent incident dialysis within ≤4 months vs. \>4 months of starting dialysis when randomized, and randomization stratification factors as fixed effects.||2.142|-0.760|0.3500
70903236|NCT00069784|141294872|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.022||||0.6273|TWO_SIDED|95.0|0.937|1.114||For the analysis of the two coprimary efficacy outcomes, the overall Type 1 error was partitioned. The first coprimary outcome was tested at 4.4%, whereas the second coprimary outcome was tested at 1% (weighted Hochberg procedure).|Log Rank|Log-rank test stratified by double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event.|Hazard ratio (glargine/standard care) estimated by Cox regression model with treatment (glargine, standard care) as factor, stratified by double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event.|The total required number of first coprimary outcomes (2200) assumed that a hazard reduction of 14-16% was clinically significant and controlled the overall experiment-wise Type 1 error at 5% with a power of 80% for each outcome. The total number of participants needed to achieve this number of events within the planned enrollment and treatment periods was ultimately estimated to be 12 500 based on the CURE and HOPE study databases.||1.114|0.937|0.6273
70903237|NCT00069784|141294873|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.038||||0.2692|TWO_SIDED|95.0|0.972|1.109||The second coprimary outcome was tested at 1% (see above additional information for the first coprimary outcome).|Log Rank|Log-rank test stratified by double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event.|Hazard ratio (glargine/standard care) estimated by Cox regression model with treatment (glargine, standard care) as factor, stratified by double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event.|See above additional details provided for the analysis of the first coprimary outcome.||1.109|0.972|0.2692
70903238|NCT00069784|141294874|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.983|||||TWO_SIDED|95.0|0.899|1.076|||||Hazard ratio (glargine/standard care) estimated by Cox regression model with treatment (glargine, standard care) as factor, with double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event as covariates.|||1.076|0.899|
70903239|NCT00069784|141294875|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.97|||||TWO_SIDED|95.0|0.9|1.047|||||Hazard ratio (glargine/standard care) estimated by Cox regression model with treatment (glargine, standard care) as factor, with double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event as covariates.|||1.047|0.900|
70903240|NCT00069784|141294876|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72|||||TWO_SIDED|95.0|0.58|0.91|||||Odds ratio estimated using Cochran-Mantel-Haenszel (CMH) test method stratified by double-blind treatment (omega-3 PUFA or placebo) and previous cardiovascular event (yes or no).|||0.91|0.58|
70903241|NCT00045435|141294897|OTHER||Percent|47.0|||||ONE_SIDED|95.0||69.0|||||The criterion for stopping was not met.|The study was to be stopped after 20 patients if the upper bound of a 1-sided 95% confidence interval for relapse-free survival was \<35%.||69||
70903242|NCT00045435|141294898|OTHER||percent|6.0|||||ONE_SIDED|80.0|1.0||||||The stopping criterion was not met.|The study was to be stopped if the lower bound of a 1-sided 80% confidence interval for NRM was greater than 15%|||1|
70903243|NCT02172625|141294912|SUPERIORITY_OR_OTHER||week-to-week coefficient of variation %|26.0|||||TWO_SIDED||||||||This was the week-to-week coefficient of variation (CV) obtained at baseline over two different weeks in a fasted state measured at rest.|||||
70903244|NCT02172625|141294913|SUPERIORITY_OR_OTHER||week-to-week coefficient of variation %|15.0|||||TWO_SIDED||||||||This was the week-to-week coefficient of variation (CV) obtained at baseline over two different weeks in a fasted state measured at rest.|||||
70903245|NCT02172625|141294917|SUPERIORITY_OR_OTHER||week-to-week coefficient of variation %|24.0|||||TWO_SIDED||||||||This was the week-to-week coefficient of variation (CV) obtained at baseline over two different weeks in a fasted state measured at rest.|||||
70903246|NCT00186498|141294921|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||||||Test of within subjects contrast: CVLT Long Delay Free Recall Time 1 (baseline) vs Time 2 (30 days): Placebo (F 4.093) p= 0.071; Memantine (F 35.042) p=0.006|Regression, Linear|||||||0.006
70903247|NCT00462670|141294989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.58|-0.6|||t-test, 2 sided|||||-0.60|-1.58|<0.0001
70903248|NCT00462670|141294990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.73|STANDARD_ERROR_OF_MEAN|0.45|<|0.0001|TWO_SIDED|95.0|-2.54|-0.92|||t-test, 2 sided|||||-0.92|-2.54|<0.0001
70903249|NCT02948959|141295007|SUPERIORITY|To control the type-I error rate for the analysis of outcome measure, a hierarchical testing procedure was applied at a 2-sided 5% significant level. Testing was then performed sequentially in the order endpoints were reported. Hierarchical testing sequence continued only if the previous endpoint was statistically significant.|Risk Ratio (RR)|0.353|||<|0.0001|TWO_SIDED|95.0|0.222|0.562||Threshold for statistical significance at 5% significant level.|Negative binomial model||Risk ratio, also called relative risk compares the risk (rate) of an event among one group with the risk (rate) among another group.|Risk ratio and p-value was derived using negative binomial model with total number of events onset from randomization up to Week 52 visit or last contact date (whichever comes earlier) as response variable, with treatment group, age, baseline weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level and number of severe exacerbation events within 1 year prior to study as covariates and log-transformed standardized observation duration as an offset variable.||0.562|0.222|<0.0001
70903250|NCT02948959|141295008|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|Risk Ratio (RR)|0.407|||<|0.0001|TWO_SIDED|95.0|0.274|0.605||Threshold for statistical significance at 5% significant level.|Negative binomial model||Risk ratio, also called relative risk compares the risk (rate) of an event among one group with the risk (rate) among another group.|Risk ratio and p-value was derived using negative binomial model with total number of events onset from randomization up to Week 52 visit or last contact date (whichever comes earlier) as response variable, with treatment group, age, baseline weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level and number of severe exacerbation events within 1 year prior to study as covariates and log-transformed standardized observation duration as an offset variable.||0.605|0.274|<0.0001
70963643|NCT01554488|141432229|OTHER||Mean Difference (Net)|-1.03|||||TWO_SIDED|95.0|-5.03|2.92||||||All of the comparisons were based on mixed effects linear regression models with visit and group\*visit as fixed effects and subject as a random effect. Confidence intervals for the treatment difference (group\*visit interaction) were constructed using the Wald method.||2.92|-5.03|
70903251|NCT02948959|141295009|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|LS mean difference|5.32||||0.0036|TWO_SIDED|95.0|1.76|8.88||Threshold for statistical significance at 5% significant level.|Mixed-effect model with repeated measure|||P-value and LS mean difference were derived from MMRM model with change from baseline in pre-bronchodilator % predicted FEV1 value up to Week 12 as the response variable, and treatment, baseline weight group, region, ethnicity, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline % predicted FEV1 value and baseline-by-visit interaction as covariates.||8.88|1.76|0.0036
70903252|NCT02948959|141295010|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|LS mean difference|5.21||||0.0009|TWO_SIDED|95.0|2.14|8.27||Threshold for statistical significance at 5% significant level.|Mixed-effect model with repeated measure|||P-value and LS mean difference were derived from MMRM model with change from baseline in pre-bronchodilator % predicted FEV1 value up to Week 12 as the response variable, and treatment, baseline weight group, region, ethnicity, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline % predicted FEV1 value and baseline-by visit interaction as covariates.||8.27|2.14|0.0009
70903253|NCT02948959|141295011|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|LS mean difference|-0.46|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.26||Threshold for statistical significance at 5% significant level.|Mixed-effect model with repeated measure|||P-value and LS mean difference were derived from MMRM model with change from baseline in ACQ-7-IA up to Week 52 as the response variable, and treatment, age, weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline ACQ-7-IA and baseline-by-visit interaction as covariates.||-0.26|-0.66|<0.0001
70903254|NCT02948959|141295012|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|LS mean difference|-0.33||||0.0001|TWO_SIDED|95.0|-0.5|-0.16||Threshold for statistical significance at 5% significant level.|Mixed-effect model with repeated measure|||P-value and LS mean difference were derived from MMRM model with change from baseline in ACQ-7-IA up to Week 52 as the response variable, and treatment, age, weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline ACQ-7-IA and baseline-by-visit interaction as covariates.||-0.16|-0.50|0.0001
70903255|NCT02948959|141295013|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|LS mean difference|-20.59|||<|0.0001|TWO_SIDED|95.0|-24.6|-16.59||Threshold for statistical significance at 5% significant level.|Mixed-effect model with repeated measure|||P-value and LS mean difference were derived from MMRM model with change from baseline in FeNO up to Week 12 as the response variable, and treatment, age, weight group, region, baseline eosinophil level, baseline ICS dose level, visit, treatment by-visit interaction, baseline FeNO value and baseline-by-visit interaction as covariates.||-16.59|-24.60|<0.0001
70903256|NCT02948959|141295014|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|LS mean difference|-17.84|||<|0.0001|TWO_SIDED|95.0|-21.05|-14.63||Threshold for statistical significance at 5% significant level.|Mixed-effect model with repeated measure|||P-value and LS mean difference were derived from MMRM model with change from baseline in FeNO up to Week 12 as the response variable, and treatment, age, weight group, region, baseline eosinophil level, baseline ICS dose level, visit, treatment by-visit interaction, baseline FeNO value and baseline-by-visit interaction as covariates.||-14.63|-21.05|<0.0001
70903257|NCT00152009|141295133|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||0.0006
70903258|NCT00152009|141295133|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||0.0005
70903259|NCT00152009|141295133|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||<0.0001
70903260|NCT00152009|141295134|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||0.025
70903261|NCT00152009|141295134|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||0.035
70903262|NCT00152009|141295134|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||<0.0001
70903263|NCT00152009|141295135|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||<0.0001
70903264|NCT00152009|141295135|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||<0.0001
70903265|NCT00152009|141295135|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||<0.0001
70903266|NCT00152009|141295136|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
70903267|NCT00152009|141295136|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0016||95.0|||||Cochran-Mantel-Haenszel|||||||0.0016
70903268|NCT00152009|141295136|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||0.0001
70903269|NCT00152009|141295137|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
70903270|NCT00152009|141295137|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0013||95.0|||||Cochran-Mantel-Haenszel|||||||0.0013
70903271|NCT00152009|141295137|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
70903272|NCT00152009|141295138|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1438||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||Psychosocial category||||0.1438
70903273|NCT00152009|141295138|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1426||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||Psychosocial category||||0.1426
70903274|NCT00152009|141295138|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0191||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||Psychosocial category||||0.0191
70903275|NCT00393523|141295139|SUPERIORITY_OR_OTHER||Seroprotection rate (SPR)|95.0|||<|0.001||95.2|92.1|97.1||"Adequate SPR required the lower bound of the 95.2% CI for the SPR for subjects in both Group 1 and Group 2 to be \> 90% (P-Value \< .024).~Since only one group met the criteria, that group was retested at α=.012."|Hochberg's step up|The primary hypothesis was evaluated using Hochberg's step up approach to control multiplicity.|Seroprotection rate (SPR)- defined as the percentage of subjects who demonstrate antibodies to hepatitis B surface antigen ≥10 mIU/mL|The primary purpose of this study was to show that subjects who received a primary series of RECOMBIVAX HB™ in the first year of life were adequately protected by RECOMBIVAX HB™ by measuring the immune response to a single booster dose of either a modified process vaccine or ENGERIX-B™.||97.1|92.1|<0.001
70903276|NCT00393523|141295139|SUPERIORITY_OR_OTHER||Seroprotection rate (SPR)|95.0|||<|0.001||97.6|91.6|97.3||Adequate SPR required the lower bound of the 95.2% CI for the SPR for subjects in both Group 1 and Group 2 to be \> 90% (P-Value \< .024). Since only one group met the criteria, that group was retested at α=.012.|Hochberg's step up|The primary hypothesis was evaluated using Hochberg's step up approach to control multiplicity.|Seroprotection rate (SPR)- defined as the percentage of subjects who demonstrate antibodies to hepatitis B surface antigen ≥10 mIU/mL|The primary purpose of this study was to show that subjects who received a primary series of RECOMBIVAX HB™ in the first year of life were adequately protected by RECOMBIVAX HB™ by measuring the immune response to a single booster dose of either a modified process vaccine or ENGERIX-B™.||97.3|91.6|<0.001
70903277|NCT00393523|141295139|SUPERIORITY_OR_OTHER||Seroprotection rate (SPR)|91.6||||0.19||95.2|88.0|94.4||"Adequate SPR required the lower bound of the 95.2% CI for the SPR for subjects in both Group 1 and Group 2 to be \> 90% (P-Value \< .024).~Since only one group met the criteria, that group was retested at α=.012."|Hochberg's step up|The primary hypothesis was evaluated using Hochberg's step up approach to control multiplicity.|Seroprotection rate (SPR)- defined as the percentage of subjects who demonstrate antibodies to hepatitis B surface antigen ≥10 mIU/mL|The primary purpose of this study was to show that subjects who received a primary series of RECOMBIVAX HB™ in the first year of life were adequately protected by RECOMBIVAX HB™ by measuring the immune response to a single booster dose of either a modified process vaccine or ENGERIX-B™.||94.4|88.0|0.19
70903278|NCT00393523|141295140|SUPERIORITY_OR_OTHER||Seroprotection Rate (SPR)|97.3||||||95.0|95.0|98.8|||||"Exact binomial confidence interval~Seroprotection Rate (SPR)- defined as the percentage of subjects who demonstrate antibodies to hepatitis B surface antigen ≥10 mIU/mL"|The purpose of the secondary analysis is to demonstrate that there is an adequate SPR in subjects who received a primary vaccination series of ENGERIX-B™ and a booster dose of modified process hepatitis B vaccine. An adequate response requires the lower bound of the two-sided 95% confidence interval for the SPR to exceed 90%.||98.8|95.0|
70903279|NCT02541383|141295187|SUPERIORITY||Odds Ratio (OR)|1.6||||0.001|TWO_SIDED|95.0|1.21|2.12|||Cochran-Mantel-Haenszel|||||2.12|1.21|0.0010
70903280|NCT02541383|141295188|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.42|0.68|||Log Rank|||||0.68|0.42|<0.0001
70903281|NCT02541383|141295189|SUPERIORITY||Hazard Ratio (HR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.52|0.72|||Log Rank|||||0.72|0.52|<0.0001
70963644|NCT02877927|141432238|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|5.0|||||TWO_SIDED|95.0|-0.2|10.3|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||10.3|-0.2|
70963645|NCT02877927|141432239|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|3.3|||||TWO_SIDED|95.0|-2.2|8.9|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||8.9|-2.2|
70963646|NCT02877927|141432240|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|2.3|||||TWO_SIDED|95.0|-0.6|5.6|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||5.6|-0.6|
70963647|NCT00708175|141432241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.17|TWO_SIDED|95.0|-1.33|0.24||P-value is from a 1-way ANCOVA with treatment group as a factor and baseline BMD as a covariate. There were no multiplicity adjustments.|ANCOVA|||The sample size was calculated using a precision approach to estimate the difference between the pioglitazone and placebo treatment groups in the percent change from baseline in BMD.||0.24|-1.33|0.170
70963648|NCT00708175|141432242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.64|TWO_SIDED|95.0|-0.91|0.56||P-value is from a 1-way ANCOVA with treatment group as a factor and the Month 12 BMD value as a covariate. There were no multiplicity adjustments.|ANCOVA|||||0.56|-0.91|0.640
70903282|NCT05458024|141295192|SUPERIORITY||Beta coefficient|-0.14||||0.83|TWO_SIDED||||||Mixed Models Analysis|||||||0.83
70903283|NCT05458024|141295193|SUPERIORITY||Beta coefficient|-1.41||||0.21|TWO_SIDED|||||Analyses were adjusted for sex, baseline pain, and baseline vitamin D levels.|Mixed Models Analysis|||||||0.21
70903284|NCT03635489|141295238|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.17|0.53|||Regression, Cox|||||0.53|0.17|<.0001
70903285|NCT03635489|141295238|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.34|||<|0.0001|TWO_SIDED|95.0|0.2|0.58|||Regression, Cox|||||0.58|0.20|<.0001
70903286|NCT03635489|141295239|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.3|1.21||||||||1.21|0.30|
70903287|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-75.0||||0.4788|TWO_SIDED|95.0|-284.8|134.9|||Mixed Models Analysis|||Placebo versus GSK1399686 10 mg for ACTH 1||134.9|-284.8|0.4788
70903288|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|124.1||||0.2309|TWO_SIDED|95.0|-80.6|328.9|||Mixed Models Analysis|||Placebo versus GSK1399686 30 mg for ACTH 1||328.9|-80.6|0.2309
70903289|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-185.1||||0.0758|TWO_SIDED|95.0|-389.8|19.7|||Mixed Models Analysis|||Placebo versus GSK1399686 100 mg for ACTH 1||19.7|-389.8|0.0758
70903290|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Median Difference (Net)|130.4||||0.2084|TWO_SIDED|95.0|-74.4|335.1|||Mixed Models Analysis|||Placebo versus GSK1399686 300 mg for ACTH 1||335.1|-74.4|0.2084
70903291|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|132.6||||0.1684|TWO_SIDED|95.0|-57.4|322.6|||Mixed Models Analysis|||Placebo versus Asacol for ACTH 1||322.6|-57.4|0.1684
70903292|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-90.4||||0.5122|TWO_SIDED|95.0|-364.7|184.0|||Mixed Models Analysis|||Placebo versus GSK1399686 10 mg for ACTH 2||184.0|-364.7|0.5122
70903293|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-75.5||||0.5417|TWO_SIDED|95.0|-321.7|170.7|||Mixed Models Analysis|||Placebo versus GSK1399686 30 mg for ACTH 2||170.7|-321.7|0.5417
70903294|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-54.4||||0.6511|TWO_SIDED|95.0|-294.2|185.3|||Mixed Models Analysis|||Placebo versus GSK1399686 100 mg for ACTH 2||185.3|-294.2|0.6511
70903295|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|64.7||||0.6117|TWO_SIDED|95.0|-189.1|318.5|||Mixed Models Analysis|||Placebo versus GSK1399686 300 mg for ACTH 2||318.5|-189.1|0.6117
70903296|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-99.7||||0.3882|TWO_SIDED|95.0|-329.3|129.9|||Mixed Models Analysis|||Placebo versus Asacol for ACTH 2||129.9|-329.3|0.3882
70903297|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-125.5||||0.4781|TWO_SIDED|95.0|-477.5|226.5|||Mixed Models Analysis|||Placebo versus GSK1399686 10 mg for ACTH effect||226.5|-477.5|0.4781
70903298|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-277.9||||0.0834|TWO_SIDED|95.0|-593.7|37.9|||Mixed Models Analysis|||Placebo versus GSK1399686 30 mg for ACTH effect||37.9|-593.7|0.0834
70963649|NCT03672461|141432282|SUPERIORITY||Model based LS mean difference|0.29||||0.056|TWO_SIDED|95.0|-0.01|0.6|||Mixed Models Analysis|adjusted for baseline value. Repeated measures mixed models, unstructured variance co-variance matrix||Null Hypothesis: Yoga is not associated with improvement in change from baseline in Total Urinary Incontinence Episodes||0.6|-0.01|0.056
70963650|NCT03672461|141432283|SUPERIORITY||Model based LS mean difference|0.03||||0.757|TWO_SIDED|95.0|-0.15|0.2|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.2|-0.15|0.757
70963651|NCT03672461|141432284|SUPERIORITY||Model based LS mean difference|0.22||||0.048|TWO_SIDED|95.0|0.0|0.45|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.45|0|0.048
70903299|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|121.7||||0.4313|TWO_SIDED|95.0|-185.8|429.3|||Mixed Models Analysis|||Placebo versus GSK1399686 100 mg for ACTH effect||429.3|-185.8|0.4313
70903300|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-73.5||||0.6528|TWO_SIDED|95.0|-399.1|252.0|||Mixed Models Analysis|||Placebo versus GSK1399686 300 mg for ACTH effect||252.0|-399.1|0.6528
70903301|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-248.5||||0.0966|TWO_SIDED|95.0|-542.9|46.0|||Mixed Models Analysis|||Placebo versus Asacol for ACTH effect||46.0|-542.9|0.0966
70903302|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|32.2||||0.7704|TWO_SIDED|95.0|-187.6|252.0|||Mixed Models Analysis|||Placebo versus GSK1399686 10 mg for ACTH morning||252.0|-187.6|0.7704
70903303|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|165.3||||0.0988|TWO_SIDED|95.0|-32.0|362.5|||Mixed Models Analysis|||Placebo versus GSK1399686 30 mg for ACTH morning||362.5|-32.0|0.0988
70903304|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-153.4||||0.1153|TWO_SIDED|95.0|-345.5|38.7|||Mixed Models Analysis|||Placebo versus GSK1399686 100 mg for ACTH morning||38.7|-345.5|0.1153
70903305|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.7||||0.9636|TWO_SIDED|95.0|-198.7|208.0|||Mixed Models Analysis|||Placebo versus GSK1399686 300 mg for ACTH morning||208.0|-198.7|0.9636
70903306|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|119.8||||0.1972|TWO_SIDED|95.0|-64.1|303.8|||Mixed Models Analysis|||Placebo versus Asacol for ACTH morning||303.8|-64.1|0.1972
70903307|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-207.6||||0.0495|TWO_SIDED|95.0|-414.6|-0.5|||Mixed Models Analysis|||Asacol versus GSK1399686 10 mg for ACTH 1||-0.5|-414.6|0.0495
70903308|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.5||||0.9333|TWO_SIDED|95.0|-210.4|193.4|||Mixed Models Analysis|||Asacol versus GSK1399686 30 mg for ACTH 1||193.4|-210.4|0.9333
70903309|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-317.7||||0.0025|TWO_SIDED|95.0|-519.6|-115.8|||Mixed Models Analysis|||Asacol versus GSK1399686 100 mg for ACTH 1||-115.8|-519.6|0.0025
70903310|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2||||0.9823|TWO_SIDED|95.0|-204.1|199.6|||Mixed Models Analysis|||Asacol versus GSK1399686 300 mg for ACTH 1||199.6|-204.1|0.9823
70903311|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.3||||0.946|TWO_SIDED|95.0|-265.0|283.7|||Mixed Models Analysis|||Asacol versus GSK1399686 10 mg for ACTH 2||283.7|-265.0|0.9460
70903312|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.2||||0.8445|TWO_SIDED|95.0|-222.0|270.4|||Mixed Models Analysis|||Asacol versus GSK1399686 30 mg for ACTH 2||270.4|-222.0|0.8445
70903313|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|45.3||||0.7069|TWO_SIDED|95.0|-194.5|285.0|||Mixed Models Analysis|||Asacol versus GSK1399686 100 mg for ACTH 2||285.0|-194.5|0.7069
70903314|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|164.4||||0.1998|TWO_SIDED|95.0|-89.4|418.2|||Mixed Models Analysis|||Asacol versus GSK1399686 300 mg for ACTH 2||418.2|-89.4|0.1998
70903315|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|123.0||||0.4871|TWO_SIDED|95.0|-229.0|474.9|||Mixed Models Analysis|||Asacol versus GSK1399686 10 mg for ACTH effect||474.9|-229.0|0.4871
70903316|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.4||||0.8527|TWO_SIDED|95.0|-345.2|286.4|||Mixed Models Analysis|||Asacol versus GSK1399686 30 mg for ACTH effect||286.4|-345.2|0.8527
70963652|NCT03672461|141432285|SUPERIORITY||Model based LS mean difference|0.82||||0.911|TWO_SIDED|95.0|-13.6|15.23|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||15.23|-13.6|0.911
70963653|NCT03672461|141432286|SUPERIORITY||Model based LS mean difference|3.13||||0.041|TWO_SIDED|95.0|0.13|6.13|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||6.13|0.13|0.041
70963654|NCT03672461|141432287|SUPERIORITY||Model based LS mean difference|0.07||||0.564|TWO_SIDED|95.0|-0.16|0.3|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.3|-0.16|0.564
70903317|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|370.2||||0.0192|TWO_SIDED|95.0|62.6|677.8|||Mixed Models Analysis|||Asacol versus GSK1399686 100 mg for ACTH effect||677.8|62.6|0.0192
70903318|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|174.9||||0.2865|TWO_SIDED|95.0|-150.6|500.5|||Mixed Models Analysis|||Asacol versus GSK1399686 300 mg for ACTH effect||500.5|-150.6|0.2865
70903319|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-87.6||||0.4279|TWO_SIDED|95.0|-307.5|132.2|||Mixed Models Analysis|||Asacol versus GSK1399686 10 mg for ACTH morning||132.2|-307.5|0.4279
70903320|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|45.4||||0.6464|TWO_SIDED|95.0|-151.8|242.7|||Mixed Models Analysis|||Asacol versus GSK1399686 30 mg for ACTH morning||242.7|-151.8|0.6464
70903321|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-273.3||||0.0061|TWO_SIDED|95.0|-465.4|-81.2|||Mixed Models Analysis|||Asacol versus GSK1399686 100 mg for ACTH morning||-81.2|-465.4|0.0061
70903322|NCT01036022|141295310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-115.2||||0.2614|TWO_SIDED|95.0|-318.5|88.1|||Mixed Models Analysis|||Asacol versus GSK1399686 300 mg for ACTH morning||88.1|-318.5|0.2614
70963655|NCT03672461|141432288|SUPERIORITY||Model based LS mean difference|0.3||||0.764|TWO_SIDED|95.0|-1.69|2.3|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||2.3|-1.69|0.764
70963656|NCT03672461|141432289|SUPERIORITY||Model based LS mean difference|-0.12||||0.883|TWO_SIDED|95.0|-1.78|1.53|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.53|-1.78|0.883
70963657|NCT03672461|141432290|SUPERIORITY||Model based LS mean difference|-0.11||||0.753|TWO_SIDED|95.0|-0.83|0.6|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.6|-0.83|0.753
70963658|NCT03672461|141432291|SUPERIORITY||Model based LS mean difference|-0.28||||0.685|TWO_SIDED|95.0|-1.63|1.07|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.07|-1.63|0.685
70963659|NCT03672461|141432292|SUPERIORITY||Model based LS mean difference|0.24||||0.691|TWO_SIDED|95.0|-0.95|1.43|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.43|-0.95|0.691
70963660|NCT03672461|141432293|SUPERIORITY||Model based LS mean difference|0.19||||0.743|TWO_SIDED|95.0|-0.95|1.34|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.34|-0.95|0.743
70963661|NCT03672461|141432294|SUPERIORITY||Model based LS mean difference|0.98||||0.043|TWO_SIDED|95.0|0.03|1.93|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.93|0.03|0.043
70963662|NCT03672461|141432295|SUPERIORITY||Model based LS mean difference|0.99||||0.689|TWO_SIDED|95.0|-3.87|5.84|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||5.84|-3.87|0.689
70963663|NCT03672461|141432296|SUPERIORITY||Model based LS mean difference|-3.4||||0.276|TWO_SIDED|95.0|-9.54|2.74|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||2.74|-9.54|0.276
70903323|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.7559|TWO_SIDED|95.0|-2.0|1.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 1 SCCAI score||1.5|-2.0|0.7559
70903324|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.1238|TWO_SIDED|95.0|-0.4|3.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 1 SCCAI score||3.2|-0.4|0.1238
70903325|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.6302|TWO_SIDED|95.0|-1.3|2.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 1 SCCAI score||2.2|-1.3|0.6302
70963664|NCT03672461|141432297|SUPERIORITY||Model based LS mean difference|0.1||||0.448|TWO_SIDED|95.0|-0.15|0.34|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.34|-0.15|0.448
70903326|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.2777|TWO_SIDED|95.0|-0.8|2.8|||Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 1 SCCAI score||2.8|-0.8|0.2777
70903327|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.8069|TWO_SIDED|95.0|-1.4|1.8||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 1 SCCAI score||1.8|-1.4|0.8069
70963665|NCT03672461|141432298|SUPERIORITY||Model based LS mean difference|-0.29||||0.319|TWO_SIDED|95.0|-0.86|0.28|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.28|-0.86|0.319
70963666|NCT03672461|141432299|SUPERIORITY||Model based LS mean difference|1.21||||0.747|TWO_SIDED|95.0|-6.25|8.67|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||8.67|-6.25|0.747
70963667|NCT03672461|141432300|SUPERIORITY||Model based LS mean difference|-2.76||||0.459|TWO_SIDED|95.0|-10.2|4.65|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||4.65|-10.2|0.459
70963668|NCT03672461|141432301|SUPERIORITY||Model based LS mean difference|-2.0||||0.556|TWO_SIDED|95.0|-10.2|4.65|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||4.65|-10.2|0.556
70963669|NCT03672461|141432302|SUPERIORITY||Model based LS mean difference|-3.26||||0.516|TWO_SIDED|95.0|-13.2|6.7|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||6.7|-13.2|0.516
70903328|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.7699|TWO_SIDED|95.0|-1.6|2.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 2 SCCAI score||2.2|-1.6|0.7699
70903329|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.3869|TWO_SIDED|95.0|-1.1|2.8||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 2 SCCAI score||2.8|-1.1|0.3869
70903330|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.6695|TWO_SIDED|95.0|-2.4|1.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 2 SCCAI score||1.5|-2.4|0.6695
70903331|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.5152|TWO_SIDED|95.0|-1.4|2.7||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 2 SCCAI score||2.7|-1.4|0.5152
70903332|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.4507|TWO_SIDED|95.0|-2.4|1.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 2 SCCAI score||1.1|-2.4|0.4507
70903333|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.8707|TWO_SIDED|95.0|-1.9|2.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 3 SCCAI score||2.3|-1.9|0.8707
70903334|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.2915|TWO_SIDED|95.0|-0.9|3.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 3 SCCAI score||3.1|-0.9|0.2915
70903335|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.7251|TWO_SIDED|95.0|-2.4|1.7||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 3 SCCAI score||1.7|-2.4|0.7251
70903336|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.4556|TWO_SIDED|95.0|-1.3|2.9||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 3 SCCAI score||2.9|-1.3|0.4556
70903337|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.662|TWO_SIDED|95.0|-2.3|1.4||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 3 SCCAI score||1.4|-2.3|0.6620
70903338|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.2844|TWO_SIDED|95.0|-1.1|3.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 4 SCCAI score||3.5|-1.1|0.2844
70903339|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.2799|TWO_SIDED|95.0|-1.0|3.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 4 SCCAI score||3.5|-1.0|0.2799
70903340|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.7655|TWO_SIDED|95.0|-1.9|2.6||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 4 SCCAI score||2.6|-1.9|0.7655
70903341|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.3332|TWO_SIDED|95.0|-1.2|3.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 4 SCCAI score||3.5|-1.2|0.3332
70903342|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.6985|TWO_SIDED|95.0|-1.6|2.4||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 4 SCCAI score||2.4|-1.6|0.6985
70903343|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.3256|TWO_SIDED|95.0|-1.3|3.7||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 5 SCCAI score||3.7|-1.3|0.3256
70903344|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.65|TWO_SIDED|95.0|-1.9|3.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 5 SCCAI score||3.0|-1.9|0.6500
70903345|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.8758|TWO_SIDED|95.0|-2.3|2.7||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 5 SCCAI score||2.7|-2.3|0.8758
70903346|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.7298|TWO_SIDED|95.0|-2.1|3.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 5 SCCAI score||3.0|-2.1|0.7298
70903347|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.5963|TWO_SIDED|95.0|-2.8|1.6||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 5 SCCAI score||1.6|-2.8|0.5963
70963670|NCT03672461|141432303|SUPERIORITY||Model based LS mean difference|-2.38||||0.154|TWO_SIDED|95.0|-5.68|0.91|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.91|-5.68|0.154
70903348|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.6498|TWO_SIDED|95.0|-2.0|3.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 6 SCCAI score||3.1|-2.0|0.6498
70903349|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.7061|TWO_SIDED|95.0|-2.0|3.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 6 SCCAI score||3.0|-2.0|0.7061
70903350|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.8549|TWO_SIDED|95.0|-2.7|2.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 6 SCCAI score||2.3|-2.7|0.8549
70903351|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.6533|TWO_SIDED|95.0|-2.0|3.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 6 SCCAI score||3.1|-2.0|0.6533
70903352|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.4378|TWO_SIDED|95.0|-3.1|1.4||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 6 SCCAI score||1.4|-3.1|0.4378
70903353|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.5917|TWO_SIDED|95.0|-2.2|1.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 1 SCCAI score||1.3|-2.2|0.5917
70903354|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.1764|TWO_SIDED|95.0|-0.5|2.9||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 1 SCCAI score||2.9|-0.5|0.1764
70903355|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.7914|TWO_SIDED|95.0|-1.5|2.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 1 SCCAI score||2.0|-1.5|0.7914
70903356|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.3578|TWO_SIDED|95.0|-0.9|2.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 1 SCCAI score||2.5|-0.9|0.3578
70903357|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.3247|TWO_SIDED|95.0|-1.0|2.9||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 2 SCCAI score||2.9|-1.0|0.3247
70903358|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.1153|TWO_SIDED|95.0|-0.4|3.4||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 2 SCCAI score||3.4|-0.4|0.1153
70903359|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.7995|TWO_SIDED|95.0|-1.7|2.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 2 SCCAI score||2.2|-1.7|0.7995
70903360|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.1786|TWO_SIDED|95.0|-0.6|3.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 2 SCCAI score||3.3|-0.6|0.1786
70903361|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.5824|TWO_SIDED|95.0|-1.5|2.7||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 3 SCCAI score||2.7|-1.5|0.5824
70903362|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.1392|TWO_SIDED|95.0|-0.5|3.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 3 SCCAI score||3.5|-0.5|0.1392
70903363|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9665|TWO_SIDED|95.0|-2.0|2.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 3 SCCAI score||2.1|-2.0|0.9665
70903364|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.2455|TWO_SIDED|95.0|-0.9|3.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 3 SCCAI score||3.3|-0.9|0.2455
70903365|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.4644|TWO_SIDED|95.0|-1.4|3.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 4 SCCAI score||3.1|-1.4|0.4644
70903366|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.4567|TWO_SIDED|95.0|-1.4|3.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 4 SCCAI score||3.0|-1.4|0.4567
70903367|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.9594|TWO_SIDED|95.0|-2.3|2.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 4 SCCAI score||2.2|-2.3|0.9594
70963671|NCT03672461|141432304|SUPERIORITY||Model based LS mean difference|-2.22||||0.375|TWO_SIDED|95.0|-7.17|2.72|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||2.72|-7.17|0.375
70903368|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.5122|TWO_SIDED|95.0|-1.5|3.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 4 SCCAI score||3.0|-1.5|0.5122
70903369|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.1493|TWO_SIDED|95.0|-0.7|4.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 5 SCCAI score||4.3|-0.7|0.1493
70903370|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.3478|TWO_SIDED|95.0|-1.3|3.6||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 5 SCCAI score||3.6|-1.3|0.3478
70903371|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.5238|TWO_SIDED|95.0|-1.7|3.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 5 SCCAI score||3.2|-1.7|0.5238
70903372|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.4091|TWO_SIDED|95.0|-1.4|3.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 5 SCCAI score||3.5|-1.4|0.4091
70903373|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.2604|TWO_SIDED|95.0|-1.1|4.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 6 SCCAI score||4.0|-1.1|0.2604
70903374|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.2809|TWO_SIDED|95.0|-1.1|3.8||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 6 SCCAI score||3.8|-1.1|0.2809
70903375|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.6038|TWO_SIDED|95.0|-1.8|3.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 6 SCCAI score||3.1|-1.8|0.6038
70903376|NCT01036022|141295312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.2511|TWO_SIDED|95.0|-1.1|3.9||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 6 SCCAI score||3.9|-1.1|0.2511
70903377|NCT01036022|141295315|SUPERIORITY_OR_OTHER||Ratio|0.75|||||TWO_SIDED|95.0|0.24|2.39||||||Placebo versus GSK1399686 10 mg for Week 1 fecal calprotectin levels||2.39|0.24|
70903378|NCT01036022|141295315|SUPERIORITY_OR_OTHER||Ratio|0.64|||||TWO_SIDED|95.0|0.21|1.92||||||Placebo versus GSK1399686 30 mg for Week 1 fecal calprotectin levels||1.92|0.21|
70903379|NCT01036022|141295315|SUPERIORITY_OR_OTHER||Ratio|0.8|||||TWO_SIDED|95.0|0.26|2.48||||||Placebo versus GSK1399686 100 mg for Week 1 fecal calprotectin levels||2.48|0.26|
70903380|NCT01036022|141295315|SUPERIORITY_OR_OTHER||Ratio|0.85|||||TWO_SIDED|95.0|0.27|2.68||||||Placebo versus GSK1399686 300 mg for Week 1 fecal calprotectin levels||2.68|0.27|
70903381|NCT01036022|141295315|SUPERIORITY_OR_OTHER||Ratio|0.64|||||TWO_SIDED|95.0|0.23|1.81||||||Placebo versus Asacol for Week 1 fecal calprotectin levels||1.81|0.23|
70903382|NCT01036022|141295315|SUPERIORITY_OR_OTHER||Ratio|0.85|||||TWO_SIDED|95.0|0.26|2.73||||||Placebo versus GSK1399686 10 mg for Week 2 fecal calprotectin levels||2.73|0.26|
70903383|NCT01036022|141295315|SUPERIORITY_OR_OTHER||Ratio|0.55|||||TWO_SIDED|95.0|0.18|1.68||||||Placebo versus GSK1399686 30 mg for Week 2 fecal calprotectin levels||1.68|0.18|
70903384|NCT01036022|141295315|SUPERIORITY_OR_OTHER||Ratio|0.67|||||TWO_SIDED|95.0|0.21|2.18||||||Placebo versus GSK1399686 100 mg for Week 2 fecal calprotectin levels||2.18|0.21|
70903385|NCT01036022|141295315|SUPERIORITY_OR_OTHER||Ratio|0.62|||||TWO_SIDED|95.0|0.19|2.03||||||Placebo versus GSK1399686 300 mg for Week 2 fecal calprotectin levels||2.03|0.19|
70903386|NCT01036022|141295315|SUPERIORITY_OR_OTHER||Ratio|0.64|||||TWO_SIDED|95.0|0.22|1.9||||||Placebo versus Asacol for Week 2 fecal calprotectin levels||1.90|0.22|
70903387|NCT01036022|141295315|SUPERIORITY_OR_OTHER||Ratio|1.07|||||TWO_SIDED|95.0|0.28|4.09||||||Placebo versus GSK1399686 10 mg for Week 3 fecal calprotectin levels||4.09|0.28|
70903388|NCT01036022|141295315|SUPERIORITY_OR_OTHER||Ratio|0.74|||||TWO_SIDED|95.0|0.23|2.43||||||Placebo versus GSK1399686 30 mg for Week 3 fecal calprotectin levels||2.43|0.23|
70903389|NCT01036022|141295315|SUPERIORITY_OR_OTHER||Ratio|0.62|||||TWO_SIDED|95.0|0.18|2.08||||||Placebo versus GSK1399686 100 mg for Week 3 fecal calprotectin levels||2.08|0.18|
70903390|NCT01036022|141295315|SUPERIORITY_OR_OTHER||Ratio|0.6|||||TWO_SIDED|95.0|0.17|2.08||||||Placebo versus GSK1399686 300 mg for Week 3 fecal calprotectin levels||2.08|0.17|
70903391|NCT01036022|141295315|SUPERIORITY_OR_OTHER||Ratio|0.44|||||TWO_SIDED|95.0|0.15|1.32||||||Placebo versus Asacol for Week 3 fecal calprotectin levels||1.32|0.15|
70903392|NCT01036022|141295315|SUPERIORITY_OR_OTHER||Ratio|1.29|||||TWO_SIDED|95.0|0.33|5.04||||||Placebo versus GSK1399686 10 mg for Week 4 fecal calprotectin levels||5.04|0.33|
70903393|NCT01036022|141295315|SUPERIORITY_OR_OTHER||Ratio|0.64|||||TWO_SIDED|95.0|0.2|2.02||||||Placebo versus GSK1399686 30 mg for Week 4 fecal calprotectin levels||2.02|0.20|
70903394|NCT01036022|141295315|SUPERIORITY_OR_OTHER||Ratio|0.96|||||TWO_SIDED|95.0|0.29|3.23||||||Placebo versus GSK1399686 100 mg for Week 4 fecal calprotectin levels||3.23|0.29|
70903395|NCT01036022|141295315|SUPERIORITY_OR_OTHER||Ratio|1.36|||||TWO_SIDED|95.0|0.39|4.72||||||Placebo versus GSK1399686 300 mg for Week 4 fecal calprotectin levels||4.72|0.39|
70903396|NCT01036022|141295315|SUPERIORITY_OR_OTHER||Ratio|0.82|||||TWO_SIDED|95.0|0.28|2.42||||||Placebo versus Asacol for Week 4 fecal calprotectin levels||2.42|0.28|
70903397|NCT01036022|141295315|SUPERIORITY_OR_OTHER||Ratio|0.61|||||TWO_SIDED|95.0|0.14|2.66||||||Placebo versus GSK1399686 10 mg for Week 5 fecal calprotectin levels||2.66|0.14|
70903398|NCT01036022|141295315|SUPERIORITY_OR_OTHER||Ratio|1.25|||||TWO_SIDED|95.0|0.35|4.38||||||Placebo versus GSK1399686 30 mg for Week 5 fecal calprotectin levels||4.38|0.35|
70903399|NCT01036022|141295315|SUPERIORITY_OR_OTHER||Ratio|0.71|||||TWO_SIDED|95.0|0.2|2.47||||||Placebo versus GSK1399686 100 mg for Week 5 fecal calprotectin levels||2.47|0.20|
70903400|NCT01036022|141295315|SUPERIORITY_OR_OTHER||Ratio|0.41|||||TWO_SIDED|95.0|0.11|1.46||||||Placebo versus GSK1399686 300 mg for Week 5 fecal calprotectin levels||1.46|0.11|
70903401|NCT01036022|141295315|SUPERIORITY_OR_OTHER||Ratio|0.47|||||TWO_SIDED|95.0|0.15|1.48||||||Placebo versus Asacol for Week 5 fecal calprotectin levels||1.48|0.15|
70903402|NCT01036022|141295315|SUPERIORITY_OR_OTHER||Ratio|0.66|||||TWO_SIDED|95.0|0.13|3.39||||||Placebo versus GSK1399686 10 mg for Week 6 fecal calprotectin levels||3.39|0.13|
70903403|NCT01036022|141295315|SUPERIORITY_OR_OTHER||Ratio|0.44|||||TWO_SIDED|95.0|0.11|1.84||||||Placebo versus GSK1399686 30 mg for Week 6 fecal calprotectin levels||1.84|0.11|
70903404|NCT01036022|141295315|SUPERIORITY_OR_OTHER||Ratio|0.37|||||TWO_SIDED|95.0|0.09|1.48||||||Placebo versus GSK1399686 100 mg for Week 6 fecal calprotectin levels||1.48|0.09|
70903405|NCT01036022|141295315|SUPERIORITY_OR_OTHER||Ratio|0.76|||||TWO_SIDED|95.0|0.19|2.99||||||Placebo versus GSK1399686 300 mg for Week 6 fecal calprotectin levels||2.99|0.19|
70903406|NCT01036022|141295315|SUPERIORITY_OR_OTHER||Ratio|0.72|||||TWO_SIDED|95.0|0.21|2.49||||||Placebo versus Asacol for Week 6 fecal calprotectin levels||2.49|0.21|
70903407|NCT01036022|141295316|SUPERIORITY_OR_OTHER||Ratio|1.19|||||TWO_SIDED|95.0|0.42|3.38||||||Placebo versus GSK1399686 10 mg for Week 1 fecal lactoferrin levels||3.38|0.42|
70903408|NCT01036022|141295316|SUPERIORITY_OR_OTHER||Ratio|1.35|||||TWO_SIDED|95.0|0.5|3.65||||||Placebo versus GSK1399686 30 mg for Week 1 fecal lactoferrin levels||3.65|0.50|
70903409|NCT01036022|141295316|SUPERIORITY_OR_OTHER||Ratio|1.25|||||TWO_SIDED|95.0|0.45|3.47||||||Placebo versus GSK1399686 100 mg for Week 1 fecal lactoferrin levels||3.47|0.45|
70903410|NCT01036022|141295316|SUPERIORITY_OR_OTHER||Ratio|1.26|||||TWO_SIDED|95.0|0.44|3.59||||||Placebo versus GSK1399686 300 mg for Week 1 fecal lactoferrin levels||3.59|0.44|
70903411|NCT01036022|141295316|SUPERIORITY_OR_OTHER||Ratio|1.28|||||TWO_SIDED|95.0|0.5|3.28||||||Placebo versus Asacol for Week 1 fecal lactoferrin levels||3.28|0.50|
70903412|NCT01036022|141295316|SUPERIORITY_OR_OTHER||Ratio|0.76|||||TWO_SIDED|95.0|0.26|2.19||||||Placebo versus GSK1399686 10 mg for Week 2 fecal lactoferrin levels||2.19|0.26|
70903413|NCT01036022|141295316|SUPERIORITY_OR_OTHER||Ratio|0.59|||||TWO_SIDED|95.0|0.22|1.63||||||Placebo versus GSK1399686 30 mg for Week 2 fecal lactoferrin levels||1.63|0.22|
70903414|NCT01036022|141295316|SUPERIORITY_OR_OTHER||Ratio|0.35|||||TWO_SIDED|95.0|0.12|1.0||||||Placebo versus GSK1399686 100 mg for Week 2 fecal lactoferrin levels||1.00|0.12|
70903415|NCT01036022|141295316|SUPERIORITY_OR_OTHER||Ratio|0.93|||||TWO_SIDED|95.0|0.31|2.77||||||Placebo versus GSK1399686 300 mg for Week 2 fecal lactoferrin levels||2.77|0.31|
70903416|NCT01036022|141295316|SUPERIORITY_OR_OTHER||Ratio|0.7|||||TWO_SIDED|95.0|0.26|1.87||||||Placebo versus Asacol for Week 2 fecal lactoferrin levels||1.87|0.26|
70903417|NCT01036022|141295316|SUPERIORITY_OR_OTHER||Ratio|0.53|||||TWO_SIDED|95.0|0.15|1.84||||||Placebo versus GSK1399686 10 mg for Week 3 fecal lactoferrin levels||1.84|0.15|
70903418|NCT01036022|141295316|SUPERIORITY_OR_OTHER||Ratio|0.96|||||TWO_SIDED|95.0|0.32|2.87||||||Placebo versus GSK1399686 30 mg for Week 3 fecal lactoferrin levels||2.87|0.32|
70903419|NCT01036022|141295316|SUPERIORITY_OR_OTHER||Ratio|0.52|||||TWO_SIDED|95.0|0.17|1.56||||||Placebo versus GSK1399686 100 mg for Week 3 fecal lactoferrin levels||1.56|0.17|
70903420|NCT01036022|141295316|SUPERIORITY_OR_OTHER||Ratio|1.42|||||TWO_SIDED|95.0|0.45|4.46||||||Placebo versus GSK1399686 300 mg for Week 3 fecal lactoferrin levels||4.46|0.45|
70903421|NCT01036022|141295316|SUPERIORITY_OR_OTHER||Ratio|0.37|||||TWO_SIDED|95.0|0.14|1.01||||||Placebo versus Asacol for Week 3 fecal lactoferrin levels||1.01|0.14|
70903422|NCT01036022|141295316|SUPERIORITY_OR_OTHER||Ratio|0.33|||||TWO_SIDED|95.0|0.1|1.15||||||Placebo versus GSK1399686 10 mg for Week 4 fecal lactoferrin levels||1.15|0.10|
70903423|NCT01036022|141295316|SUPERIORITY_OR_OTHER||Ratio|0.68|||||TWO_SIDED|95.0|0.23|2.03||||||Placebo versus GSK1399686 30 mg for Week 4 fecal lactoferrin levels||2.03|0.23|
70903424|NCT01036022|141295316|SUPERIORITY_OR_OTHER||Ratio|0.56|||||TWO_SIDED|95.0|0.19|1.68||||||Placebo versus GSK1399686 100 mg for Week 4 fecal lactoferrin levels||1.68|0.19|
70903425|NCT01036022|141295316|SUPERIORITY_OR_OTHER||Ratio|1.19|||||TWO_SIDED|95.0|0.38|3.7||||||Placebo versus GSK1399686 300 mg for Week 4 fecal lactoferrin levels||3.70|0.38|
70903426|NCT01036022|141295316|SUPERIORITY_OR_OTHER||Ratio|0.71|||||TWO_SIDED|95.0|0.26|1.89||||||Placebo versus Asacol for Week 4 fecal lactoferrin levels||1.89|0.26|
70903427|NCT01036022|141295316|SUPERIORITY_OR_OTHER||Ratio|1.05|||||TWO_SIDED|95.0|0.27|4.07||||||Placebo versus GSK1399686 10 mg for Week 5 fecal lactoferrin levels||4.07|0.27|
70903428|NCT01036022|141295316|SUPERIORITY_OR_OTHER||Ratio|1.48|||||TWO_SIDED|95.0|0.46|4.73||||||Placebo versus GSK1399686 30 mg for Week 5 fecal lactoferrin levels||4.73|0.46|
70903429|NCT01036022|141295316|SUPERIORITY_OR_OTHER||Ratio|0.33|||||TWO_SIDED|95.0|0.11|1.02||||||Placebo versus GSK1399686 100 mg for Week 5 fecal lactoferrin levels||1.02|0.11|
70903430|NCT01036022|141295316|SUPERIORITY_OR_OTHER||Ratio|1.16|||||TWO_SIDED|95.0|0.36|3.73||||||Placebo versus GSK1399686 300 mg for Week 5 fecal lactoferrin levels||3.73|0.36|
70903431|NCT01036022|141295316|SUPERIORITY_OR_OTHER||Ratio|0.82|||||TWO_SIDED|95.0|0.29|2.33||||||Placebo versus Asacol for Week 5 fecal lactoferrin levels||2.33|0.29|
70903432|NCT01036022|141295316|SUPERIORITY_OR_OTHER||Ratio|1.44|||||TWO_SIDED|95.0|0.31|6.59||||||Placebo versus GSK1399686 10 mg for Week 6 fecal lactoferrin levels||6.59|0.31|
70903433|NCT01036022|141295316|SUPERIORITY_OR_OTHER||Ratio|2.21|||||TWO_SIDED|95.0|0.54|9.04||||||Placebo versus GSK1399686 30 mg for Week 6 fecal lactoferrin levels||9.04|0.54|
70903434|NCT01036022|141295316|SUPERIORITY_OR_OTHER||Ratio|0.41|||||TWO_SIDED|95.0|0.11|1.48||||||Placebo versus GSK1399686 100 mg for Week 6 fecal lactoferrin levels||1.48|0.11|
70903435|NCT01036022|141295316|SUPERIORITY_OR_OTHER||Ratio|1.64|||||TWO_SIDED|95.0|0.46|5.91||||||Placebo versus GSK1399686 300 mg for Week 6 fecal lactoferrin levels||5.91|0.46|
70903436|NCT01036022|141295316|SUPERIORITY_OR_OTHER||Ratio|0.84|||||TWO_SIDED|95.0|0.27|2.62||||||Placebo versus Asacol for Week 6 fecal lactoferrin levels||2.62|0.27|
70963672|NCT03672461|141432305|SUPERIORITY||Model based LS mean difference|-1.75||||0.287|TWO_SIDED|95.0|-5.0|1.5|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, with unstructured variance co-variance matrix||||1.5|-5|0.287
70963673|NCT03672461|141432306|SUPERIORITY||Model based LS mean difference|-1.63||||0.147|TWO_SIDED|95.0|-3.85|0.58||adjusted for baseline value Repeated measures mixed models, with unstructured variance co-variance matrix|Mixed Models Analysis|||||0.58|-3.85|0.147
70963674|NCT03672461|141432307|SUPERIORITY||Model based LS mean difference|-1.37||||0.495|TWO_SIDED|95.0|-5.36|2.61|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, with unstructured variance co-variance matrix||||2.61|-5.36|0.495
70963675|NCT03672461|141432308|SUPERIORITY||Model based LS mean difference|-2.82||||0.303|TWO_SIDED|95.0|-8.22|2.59|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||2.59|-8.22|0.303
70963676|NCT03672461|141432309|SUPERIORITY||Model based LS mean difference|2.97||||0.196|TWO_SIDED|95.0|-1.56|7.51|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||7.51|-1.56|0.196
70963677|NCT03219320|141432316|OTHER|||||||0.004|||||||Mixed Models Analysis|||||||0.004
70963678|NCT03739762|141432317|SUPERIORITY||Mean Difference (Final Values)|-31.85||||0.003|TWO_SIDED|95.0|-52.91|-10.79|||Regression, Linear|The model fit was a linear regression model with GEE on the outcome change from baseline.||The sample size of 284 ensured 90% power to detect a 41-minute difference in sitting time between I-STAND and the attention control from baseline to 6 months, assuming a standard deviation (SD) of 97 minutes/day for change in sitting time (based on our pilot data), and 15% loss to follow-up. Sample and power calculations were performed using R software version 3.5 \[39\] via simulation, assuming specified SDs and differences between means.||-10.79|-52.91|0.003
70963679|NCT03739762|141432318|SUPERIORITY||Mean Difference (Final Values)|-3.48||||0.033|TWO_SIDED|95.0|-6.68|-0.28|||Regression, Linear|The model fit was a linear regression model with GEE on the outcome change from baseline.||||-0.28|-6.68|.033
70963680|NCT03739762|141432319|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.784|TWO_SIDED|95.0|-1.63|2.16|||Regression, Linear|The model fit was a linear regression model with GEE on the outcome change from baseline.||||2.16|-1.63|.784
70963681|NCT03739762|141432320|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.927|TWO_SIDED|95.0|-2.61|2.38|||Regression, Linear|The model fit was a linear regression model with GEE on the outcome change from baseline.||||2.38|-2.61|.927
70963682|NCT03739762|141432321|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.916|TWO_SIDED|95.0|-0.42|0.47|||Regression, Linear|The model fit was a linear regression model with GEE on the outcome change from baseline.||||0.47|-0.42|.916
70963683|NCT03739762|141432322|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.325|TWO_SIDED|95.0|-1.09|0.36|||Regression, Linear|The model fit was a linear regression model with GEE on the outcome change from baseline.||||0.36|-1.09|.325
70963684|NCT01681810|141432323|OTHER|Paired t-test comparing insulin stimulated glucose disposal at end of 12 weeks on nitrite drug to baseline (pre-drug) insulin stimulated glucose disposal.||||||0.2068|||||||t-test, 2 sided|||||||0.2068
70963685|NCT01681810|141432324|OTHER|One-way repeated measures ANOVA comparing blood pressure over time on nitrite drug to baseline (pre-drug) blood pressure.||||||0.0074||||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|||||||0.0074
70963686|NCT01681810|141432325|OTHER|One-way repeated measures ANOVA comparing blood pressure over time on nitrite drug to baseline (pre-drug) blood pressure.|||||<|0.0001||||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|||||||<0.0001
70963687|NCT01681810|141432326|OTHER|One-way repeated measures ANOVA comparing blood pressure over time on nitrite drug to baseline (pre-drug) blood pressure.|||||<|0.0001||||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|||||||<0.0001
70963688|NCT01681810|141432327|OTHER|One-way repeated measures ANOVA comparing methemoglobin percent over time on nitrite drug to baseline (pre-drug) methemoglobin percent.||||||0.0127||||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|||||||0.0127
70963689|NCT02294682|141432350|SUPERIORITY_OR_OTHER||Microbio Response Urogenital Gonorrhea|97.0|||||ONE_SIDED|95.0|85.1||||||GSK2140944 1500 mg||||85.1|
70963690|NCT02294682|141432350|SUPERIORITY_OR_OTHER||Microbio Response Urogenital Gonorrhea|95.0|||||ONE_SIDED|95.0|84.7||||||GSK2140944 3000 mg||||84.7|
70963691|NCT01002456|141432408|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9|||||TWO_SIDED|95.0|1.1|3.2|||||Proportional odds ratio to measure the trend of change in concordance with guideline recommendations, with Arm 1 as the comparator.|||3.2|1.1|
70963692|NCT00129623|141432411|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.1226|||<|0.0001|TWO_SIDED|95.0|2.9613|5.2838||The primary analysis was an ANOVA (two way classification), including treatment group and time since menopause (as a binary variable; 0.5-3 years, \>3 years) as independent factors.|ANOVA|||"H0 (null hypothesis): There was no statistically significant difference between monthly treatment with 150 mg oral IBN and monthly treatment with placebo in relative change from baseline of mean lumbar spine (L2-L4 BMD).~H1 (alternative hypothesis): There was a statistically significant difference between monthly treatment with 150 mg oral IBN and monthly treatment with placebo in relative change from baseline of mean lumbar spine (L2-L4 BMD)."||5.2838|2.9613|<0.0001
70963693|NCT00129623|141432417|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.51|||||TWO_SIDED|95.0|5.12|30.56||||||Lumbar BMD: Adjusted treatment effect - The treatment effect and 95% C.I. were represented by presenting OR. These were estimated by fitting a logistic regression model, with responder outcome (responder/non-responder) as the dependent variable and the treatment group (oral IBN 150 mg/Placebo) and time since menopause as the independent variables. An OR of \>1 indicated participants treated with IBN were more likely to have BMD above or equal to baseline relative to those treated with placebo.||30.56|5.12|
70963694|NCT00129623|141432417|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.59|||||TWO_SIDED|95.0|3.8|19.42||||||Proximal femur BMD: The adjusted treatment effect and 95% C.I. were represented by presenting OR. These were estimated by fitting a logistic regression model, with responder outcome (responder/non-responder) as the dependent variable and the treatment group (oral IBN 150 mg once monthly/Placebo) and time since menopause as the independent variables. An OR of \>1 indicated participants treated with IBN were more likely to have BMD above or equal to baseline relative to those treated with placebo.||19.42|3.80|
70963695|NCT00129623|141432417|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.8|||||TWO_SIDED|95.0|5.17|36.79||||||Lumbar Spine and Proximal Femur BMD: The adjusted treatment effect and 95% C.I. were represented by presenting OR. These were estimated by fitting a logistic regression model, with responder outcome (responder/non-responder) as the dependent variable, and treatment group (oral IBN150 mg/Placebo) and time since menopause as the independent variables. An OR of \>1 indicated participants treated with IBN were more likely to have BMD above or equal to baseline relative to those treated with placebo.||36.79|5.17|
70963696|NCT05178134|141432425|NON_INFERIORITY|Non-inferiority margin was set to -15% (on an absolute scale)|Difference in response rates|-0.02|||||TWO_SIDED|95.0|-0.108|0.069||||||||0.069|-0.108|
70963697|NCT01214187|141432444|SUPERIORITY||Mean Difference (Net)|-1.04|STANDARD_ERROR_OF_MEAN|0.81||0.2072|TWO_SIDED||||||ANOVA|Repeated measure ANOVA|Difference = (Change from baseline to Week 12 for Carbon monoxide group) minus (Change from baseline to Week 12 for Placebo group)|||||0.2072
70963698|NCT01214187|141432445|SUPERIORITY||Mean Difference (Net)|-0.85|STANDARD_ERROR_OF_MEAN|1.57||0.5882|TWO_SIDED||||||ANOVA|Repeated Measure ANOVA|Difference = (Change from baseline to week 12 for CO group) minus (Change from baseline to week 12 for placebo group)|||||0.5882
70963699|NCT01214187|141432446|SUPERIORITY||Mean Difference (Net)|0.64|STANDARD_ERROR_OF_MEAN|1.93||0.7401|TWO_SIDED||||||ANOVA|Repeated Measure ANOVA|difference=(change from baseline to week 12 for CO group) minus (change from baseline to week 12 for placebo group)|||||0.7401
70963700|NCT01214187|141432447|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-48.46|STANDARD_ERROR_OF_MEAN|18.14||0.0099|TWO_SIDED||||||ANOVA|Repeated measure ANOVA|Difference=(Change from baseline to week 12 for CO group) minus (Change from baseline to week 12 for placebo group)|||||0.0099
70963701|NCT01214187|141432448|SUPERIORITY||Mean Difference (Net)|-0.58|STANDARD_ERROR_OF_MEAN|2.42||0.8124|TWO_SIDED||||||ANOVA|Repeated measure ANOVA||||||0.8124
70963702|NCT00998426|141432453|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|||||This is the p value for the meter by time interaction|Random intercept model|||A random intercept model was used to fit the five subjects' glucose reading data over time. The fixed effect glucose meters, time effect and their interactions were included in the model.||||0.59
70963703|NCT01178333|141432454|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.98||||0.09|TWO_SIDED|95.0|0.9|4.36|||Regression, Cox|||||4.36|0.90|0.09
70963704|NCT01178333|141432454|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||0.45|TWO_SIDED|95.0|0.65|2.66|||Regression, Cox|||||2.66|0.65|0.45
70963705|NCT01178333|141432456|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.76||||0.15|TWO_SIDED|95.0|0.55|40.87|||Regression, Cox|||||40.87|0.55|0.15
70963706|NCT01178333|141432456|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.35||||0.78|TWO_SIDED|95.0|0.16|11.25|||Regression, Cox|||||11.25|0.16|0.78
70963707|NCT01178333|141432457|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.38||||0.06|TWO_SIDED|95.0|0.98|5.79|||Regression, Cox|||||5.79|0.98|0.06
70963708|NCT01178333|141432457|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.91||||0.11|TWO_SIDED|95.0|0.87|4.21|||Regression, Cox|||||4.21|0.87|0.11
70963709|NCT01178333|141432458|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.8||||0.001|TWO_SIDED|95.0|1.5|5.22|||Regression, Cox|||||5.22|1.50|0.001
70963710|NCT01178333|141432458|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.97||||0.02|TWO_SIDED|95.0|1.12|3.45|||Regression, Cox|||||3.45|1.12|0.02
70963711|NCT01178333|141432461|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|||||P-value is to compare three groups.|Chi-squared|||||||0.72
70963712|NCT01178333|141432462|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED|||||P-value is to compare three groups.|Chi-squared|||||||0.37
70963713|NCT01178333|141432463|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||P-value is to compare three groups.|Chi-squared|||||||0.02
70963714|NCT01178333|141432464|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||ANOVA|||||||0.58
70963715|NCT01178333|141432465|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Regression, Cox|||||||0.66
70963716|NCT01178333|141432466|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||P-value is to compare three groups.|Chi-squared|||||||<0.01
70963717|NCT01178333|141432467|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.48||||0.003|TWO_SIDED|95.0|1.35|4.55|||Regression, Cox|||||4.55|1.35|0.003
70963718|NCT01178333|141432467|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.66||||0.07|TWO_SIDED|95.0|0.96|2.85|||Regression, Cox|||||2.85|0.96|0.07
70963719|NCT01178333|141432469|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||P-value is to compare three groups.|Chi-squared|||||||<0.01
70963720|NCT01178333|141432470|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.72|TWO_SIDED|95.0|0.56|1.49|||Regression, Cox|||||1.49|0.56|0.72
70963721|NCT01178333|141432470|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.34|TWO_SIDED|95.0|0.54|1.24|||Regression, Cox|||||1.24|0.54|0.34
70963722|NCT01233869|141432471|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.86|||<|0.0001|TWO_SIDED|95.0|2.02|5.74|||Mixed Models Analysis|||Statistical Analysis 1 is comparison of annualized rate of kidney enlargement: placebo versus pooled bosutinib.||5.74|2.02|<0.0001
70963723|NCT01233869|141432471|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.83||||0.1234|TWO_SIDED|95.0|-0.5|4.22|||Mixed Models Analysis|||Statistical Analysis 2 is comparison of annualized rate of kidney enlargement: bosutinib 200 mg/day versus bosutinib 400/200 mg/day.||4.22|-0.50|0.1234
70963724|NCT01233869|141432471|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.06||||0.005|TWO_SIDED|95.0|0.93|5.23|||Mixed Models Analysis|||Statistical Analysis 3 is comparison of annualized rate of kidney enlargement: placebo versus bosutinib 200 mg/day.||5.23|0.93|0.0050
70963725|NCT01233869|141432471|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.41||||0.1336|TWO_SIDED|95.0|-1.03|8.05|||Mixed Models Analysis|||Statistical Analysis 4 is comparison of annualized rate of kidney enlargement: placebo versus bosutinib 400 mg/day.||8.05|-1.03|0.1336
70963726|NCT01233869|141432471|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.95|||<|0.0001|TWO_SIDED|95.0|2.65|7.3|||Mixed Models Analysis|||Statistical Analysis 5 is comparison of annualized rate of kidney enlargement: placebo versus bosutinib 400/200 mg/day.||7.30|2.65|<0.0001
70963727|NCT00537485|141432496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|1.2||0.002|TWO_SIDED|95.0|-3.7|1.1|||t-test, 2 sided|||||1.1|-3.7|0.002
70963728|NCT00537485|141432497|SUPERIORITY_OR_OTHER||Risk Difference (RD)|30.7|||<|0.001|TWO_SIDED|95.0|16.7|44.6|||Chi-squared, Corrected|||||44.6|16.7|<0.001
70963729|NCT00537485|141432497|SUPERIORITY_OR_OTHER||Risk Difference (RD)|26.1|||<|0.001|TWO_SIDED|95.0|12.0|40.2|||Chi-squared, Corrected|||||40.2|12.0|<0.001
70963730|NCT02967354|141432506|SUPERIORITY|||||||0.5875||||||Treshold for significance P\<0.05|ANOVA|||||||0.5875
70963731|NCT02967354|141432507|SUPERIORITY|||||||0.0065||||||Treshold for significance P\<0.05|ANOVA|||||||0.0065
70963732|NCT02967354|141432508|SUPERIORITY|||||||0.0072||||||Treshold for significance P\<0.05|ANOVA|||||||0.0072
70963733|NCT02967354|141432509|SUPERIORITY|||||||0.9472||||||Treshold for significance P\<0.05|ANOVA|||||||0.9472
70963734|NCT02967354|141432510|SUPERIORITY|||||||0.0048||||||Treshold for significance P\<0.05|ANOVA|||||||0.0048
70963735|NCT01241552|141432511|SUPERIORITY_OR_OTHER||Adjusted Difference|-1.7||||0.3182|TWO_SIDED|95.0|-8.6|5.5||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415 + SOC - Placebo + SOC|||5.5|-8.6|0.3182
70963736|NCT01241552|141432511|SUPERIORITY_OR_OTHER||Adjusted Difference|-10.1||||0.0003|TWO_SIDED|95.0|-15.9|-4.3||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-6072 + SOC - Placebo + SOC|||-4.3|-15.9|0.0003
70963737|NCT01241552|141432511|SUPERIORITY_OR_OTHER||Adjusted Difference|-11.6|||<|0.0001|TWO_SIDED|95.0|-17.4|-5.9||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - Placebo + SOC|||-5.9|-17.4|< 0.0001
70963738|NCT01241552|141432511|SUPERIORITY_OR_OTHER||Adjusted Difference|-9.9||||0.0013|TWO_SIDED|95.0|-16.9|-3.4||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-3415 + SOC|||-3.4|-16.9|0.0013
70963739|NCT01241552|141432511|SUPERIORITY_OR_OTHER||Adjusted Difference|-1.4||||0.2997|TWO_SIDED|95.0|-6.7|3.9||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-6072 + SOC|||3.9|-6.7|0.2997
70963740|NCT01241552|141432512|SUPERIORITY_OR_OTHER||Adjusted Difference|-8.3||||0.9775|TWO_SIDED|95.0|-16.3|-0.2||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415 + SOC - Placebo + SOC|||-0.2|-16.3|0.9775
70963741|NCT01241552|141432512|SUPERIORITY_OR_OTHER||Adjusted Difference|4.8||||0.0861|TWO_SIDED|95.0|-2.1|11.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-6072 + SOC - Placebo + SOC|||11.7|-2.1|0.0861
70963742|NCT01241552|141432512|SUPERIORITY_OR_OTHER||Adjusted Difference|3.5||||0.1646|TWO_SIDED|95.0|-3.5|10.4||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - Placebo + SOC|||10.4|-3.5|0.1646
70963743|NCT01241552|141432512|SUPERIORITY_OR_OTHER||Adjusted Difference|11.7||||0.0025|TWO_SIDED|95.0|3.5|19.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-3415 + SOC|||19.7|3.5|0.0025
70963744|NCT01241552|141432512|SUPERIORITY_OR_OTHER||Adjusted Difference|-1.4||||0.6532|TWO_SIDED|95.0|-8.3|5.5||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-6072 + SOC|||5.5|-8.3|0.6532
70963745|NCT01241552|141432513|SUPERIORITY_OR_OTHER||Adjusted Difference|1.7||||0.6505|TWO_SIDED|95.0|-6.9|10.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415 + SOC - Placebo + SOC|||10.7|-6.9|0.6505
70963746|NCT01241552|141432513|SUPERIORITY_OR_OTHER||Adjusted Difference|-10.8||||0.0013|TWO_SIDED|95.0|-17.7|-3.8||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-6072 + SOC - Placebo + SOC|||-3.8|-17.7|0.0013
70963747|NCT01241552|141432513|SUPERIORITY_OR_OTHER||Adjusted Difference|-11.7||||0.0006|TWO_SIDED|95.0|-18.6|-4.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - Placebo + SOC|||-4.7|-18.6|0.0006
70963748|NCT01241552|141432513|SUPERIORITY_OR_OTHER||Adjusted Difference|-13.7||||0.0007|TWO_SIDED|95.0|-22.5|-5.2||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-3415 + SOC|||-5.2|-22.5|0.0007
70963749|NCT01241552|141432513|SUPERIORITY_OR_OTHER||Adjusted Difference|-1.0||||0.3906|TWO_SIDED|95.0|-7.7|5.8||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-6072 + SOC|||5.8|-7.7|0.3906
70963750|NCT01241552|141432514|SUPERIORITY_OR_OTHER||Percentage Difference|5.2||||0.185|TWO_SIDED|95.0|-2.5|12.8|||Miettinen and Nurminen||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||12.8|-2.5|0.185
70963751|NCT01241552|141432514|SUPERIORITY_OR_OTHER||Percentage Difference|3.4||||0.323|TWO_SIDED|95.0|-3.3|10.1|||Miettinen and Nurminen||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||10.1|-3.3|0.323
70963752|NCT01241552|141432514|SUPERIORITY_OR_OTHER||Percentage Difference|-2.3||||0.507|TWO_SIDED|95.0|-9.1|4.5|||Miettinen and Nurminen||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||4.5|-9.1|0.507
70963753|NCT01241552|141432515|SUPERIORITY_OR_OTHER||Percentage Difference|2.2||||0.246|TWO_SIDED|95.0|-1.5|6.7|||Miettinen and Nurminen||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||6.7|-1.5|0.246
70963754|NCT01241552|141432515|SUPERIORITY_OR_OTHER||Percentage Difference|3.2||||0.069|TWO_SIDED|95.0|-0.3|6.8|||Miettinen and Nurminen||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||6.8|-0.3|0.069
70963755|NCT01241552|141432515|SUPERIORITY_OR_OTHER||Percentage Difference|1.2||||0.464|TWO_SIDED|95.0|-2.1|4.6|||Miettinen and Nurminen||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||4.6|-2.1|0.464
70963756|NCT01241552|141432516|SUPERIORITY_OR_OTHER||Percentage Difference|7.7||||0.027|TWO_SIDED|95.0|0.9|14.7|||Miettinen and Nurminen||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||14.7|0.9|0.027
70963757|NCT01241552|141432516|SUPERIORITY_OR_OTHER||Percentage Difference|1.5||||0.594|TWO_SIDED|95.0|-4.1|7.2|||Miettinen and Nurminen||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||7.2|-4.1|0.594
70963758|NCT01241552|141432516|SUPERIORITY_OR_OTHER||Percentage Difference|-5.3||||0.051|TWO_SIDED|95.0|-10.6|0.0|||Miettinen and Nurminen||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||0.0|-10.6|0.051
70963759|NCT01241552|141432517|SUPERIORITY_OR_OTHER||Percentage Difference|1.0||||0.115|TWO_SIDED|95.0|-0.3|3.5|||Miettinen and Nurminen||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||3.5|-0.3|0.115
70963760|NCT01241552|141432517|SUPERIORITY_OR_OTHER||Percentage Difference|0.8||||0.17|TWO_SIDED|95.0|-0.5|2.4|||Miettinen and Nurminen||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||2.4|-0.5|0.170
70963761|NCT01241552|141432517|SUPERIORITY_OR_OTHER||Percentage Difference|0.3||||0.544|TWO_SIDED|95.0|-0.9|1.6|||Miettinen and Nurminen||Percentage Difference: MK-3415A + SOC - Placeb + SOC|||1.6|-0.9|0.544
70963762|NCT01241552|141432518|SUPERIORITY_OR_OTHER||Percentage Difference|0.4||||0.192|TWO_SIDED|95.0|-0.5|2.4|||Miettinen and Nurminen||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||2.4|-0.5|0.192
70963763|NCT01241552|141432518|SUPERIORITY_OR_OTHER||Percentage Difference|0.3||||0.311|TWO_SIDED|95.0|-0.7|1.4|||Miettinen and Nurminen||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||1.4|-0.7|0.311
70963764|NCT01241552|141432518|SUPERIORITY_OR_OTHER||Percentage Difference|0.0|||>|0.999|TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||1.0|-1.0|> 0.999
70963765|NCT01241552|141432519|SUPERIORITY_OR_OTHER||Percentage Difference|3.6|||||TWO_SIDED|95.0|-1.0|8.7|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||8.7|-1.0|
70963766|NCT01241552|141432519|SUPERIORITY_OR_OTHER||Percentage Difference|4.3|||||TWO_SIDED|95.0|0.2|8.5|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||8.5|0.2|
70963767|NCT01241552|141432519|SUPERIORITY_OR_OTHER||Percentage Difference|1.3|||||TWO_SIDED|95.0|-2.6|5.2|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||5.2|-2.6|
70963768|NCT01241552|141432520|SUPERIORITY_OR_OTHER||Percentage Difference|-6.9|||||TWO_SIDED|95.0|-16.8|3.5|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||3.5|-16.8|
70963769|NCT01241552|141432520|SUPERIORITY_OR_OTHER||Percentage Difference|-18.0|||||TWO_SIDED|95.0|-26.3|-9.6|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||-9.6|-26.3|
70963770|NCT01241552|141432520|SUPERIORITY_OR_OTHER||Percentage Difference|-16.2|||||TWO_SIDED|95.0|-24.5|-7.7|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||-7.7|-24.5|
70963771|NCT01241552|141432521|SUPERIORITY_OR_OTHER||Percentage Difference|-6.1|||||TWO_SIDED|95.0|-20.1|8.6|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||8.6|-20.1|
70963772|NCT01241552|141432521|SUPERIORITY_OR_OTHER||Percentage Difference|-13.2|||||TWO_SIDED|95.0|-25.5|-0.5|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||-0.5|-25.5|
70963773|NCT01241552|141432521|SUPERIORITY_OR_OTHER||Percentage Difference|-14.4|||||TWO_SIDED|95.0|-26.8|-1.6|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||-1.6|-26.8|
70963774|NCT01241552|141432522|SUPERIORITY_OR_OTHER||Percentage Difference|0.8|||||TWO_SIDED|95.0|-16.9|21.0|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||21.0|-16.9|
70963775|NCT01241552|141432522|SUPERIORITY_OR_OTHER||Percentage Difference|-14.6|||||TWO_SIDED|95.0|-28.3|-1.4|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||-1.4|-28.3|
70963776|NCT01241552|141432522|SUPERIORITY_OR_OTHER||Percentage Difference|-12.1|||||TWO_SIDED|95.0|-26.2|1.9|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||1.9|-26.2|
70963777|NCT01241552|141432523|SUPERIORITY_OR_OTHER||Percentage Difference|-10.0|||||TWO_SIDED|95.0|-30.1|10.0|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||10.0|-30.1|
70963778|NCT01241552|141432523|SUPERIORITY_OR_OTHER||Percentage Difference|-25.3|||||TWO_SIDED|95.0|-43.7|-6.1|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||-6.1|-43.7|
70963779|NCT01241552|141432524|SUPERIORITY_OR_OTHER||Percentage Difference|-11.3|||||TWO_SIDED|95.0|-24.9|3.9|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||3.9|-24.9|
70963780|NCT01241552|141432524|SUPERIORITY_OR_OTHER||Percentage Difference|-12.7|||||TWO_SIDED|95.0|-24.7|-0.5|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||-0.5|-24.7|
70963781|NCT01241552|141432524|SUPERIORITY_OR_OTHER||Percentage Difference|-16.0|||||TWO_SIDED|95.0|-27.8|-4.0|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||-4.0|-27.8|
70963782|NCT01241552|141432525|SUPERIORITY_OR_OTHER||Percentage Difference|-10.1|||||TWO_SIDED|95.0|-23.2|4.6|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||4.6|-23.2|
70963783|NCT01241552|141432525|SUPERIORITY_OR_OTHER||Percentage Difference|-11.0|||||TWO_SIDED|95.0|-23.2|1.4|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||1.4|-23.2|
70963784|NCT01241552|141432525|SUPERIORITY_OR_OTHER||Percentage Difference|-16.7|||||TWO_SIDED|95.0|-28.4|-4.7|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||-4.7|-28.4|
70963785|NCT01158651|141432526|SUPERIORITY|The treatment regimen was considered promising for further study if after 48 weeks of treatment there was at least a 25% response rate compared to an expected response rate of 5% or less, which was considered evidence of an unpromising regimen. Assuming the true response rate is 5%, the binomial distribution was used to calculate Type I errors and power.|Proportion responding|0.682|||<|0.001|TWO_SIDED|95.0|0.4872|0.8764|||Exact test|||||0.8764|0.4872|<0.001
70963786|NCT05696236|141432595|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||||||0.77
70963787|NCT05696236|141432596|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
70963788|NCT05696236|141432597|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||0.006
70963789|NCT05341700|141432599|SUPERIORITY|||||||0.246|||||||Mixed Models Analysis|||Null hypothesis is that there was no difference in change of PINP between RUN and RUN+J.||||0.246
70963790|NCT05341700|141432600|SUPERIORITY|||||||0.714|||||||Mixed Models Analysis|||Null hypothesis is that there was no difference in change of CTX between RUN and RUN+J.||||0.714
70963791|NCT05341700|141432601|SUPERIORITY|||||||0.309|||||||Mixed Models Analysis|||||||0.309
70963792|NCT05341700|141432602|SUPERIORITY|||||||0.308|||||||Mixed Models Analysis|||Null hypothesis is that there was no difference in change of IGF1 between RUN and RUN+J.||||0.308
70963793|NCT05341700|141432603|SUPERIORITY|||||||0.207|||||||Mixed Models Analysis|||Null hypothesis is that there was no difference in change of ferritin between RUN and RUN+J.||||0.207
70963794|NCT01829360|141432604|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|The significance of fixed effects (e.g.,treatment) was evaluated using Wald tests||||||<0.05
70963795|NCT01829360|141432604|OTHER|A secondary analysis was performed to examine individual differences in treatment outcomes. This was done collapsed across all arms because the difference between the arms/treatments was not significant in the primary analysis. This was done by adding predictors to the primary analysis model to determine if learner characteristics were significantly related to growth in word defining. All continuous learner characteristics were grand mean centered.|||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
70963796|NCT01829360|141432605|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||The interim definition data were analyzed with the primary pre-/post-definition data to capture growth across the entire treatment period.||||<0.05
70963797|NCT02378220|141432622|OTHER||Risk Ratio (RR)|0.65||||0.21|TWO_SIDED|95.0|0.32|1.28||P-value for 30 days measure.|Regression, Poisson|||||1.28|0.32|0.21
70963798|NCT02378220|141432622|OTHER||Risk Ratio (RR)|0.48||||0.007|TWO_SIDED|95.0|0.27|0.82||P-Value for 60 days measure|Regression, Poisson|||||0.82|0.27|0.007
70963799|NCT02378220|141432623|OTHER||Risk Ratio (RR)|0.62||||0.16|TWO_SIDED|95.0|0.31|1.21||P-Value for 30 days measure|Regression, Poisson|||||1.21|0.31|0.16
70963800|NCT02378220|141432623|OTHER||Risk Ratio (RR)|0.58||||0.045|TWO_SIDED|95.0|0.34|0.99|||Regression, Poisson|||||0.99|0.34|0.045
70963801|NCT02378220|141432624|OTHER||Hazard Ratio (HR)|0.59||||0.1|TWO_SIDED|95.0|0.31|1.12|||Log Rank|||||1.12|0.31|0.10
70963802|NCT02378220|141432625|OTHER||Hazard Ratio (HR)|0.6||||0.09|TWO_SIDED|95.0|0.33|1.1|||Log Rank|||||1.10|0.33|0.09
70963803|NCT00312221|141432636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.126|TWO_SIDED|95.0|-0.8562|0.1054|||Mixed Models Analysis||Treatment comparison between BTDS 20 and BTDS 5 during the 12-week double-blind phase|||0.1054|-0.8562|0.126
70963804|NCT00312221|141432636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.14||95.0|-0.8455|0.1189|||Mixed Models Analysis||Treatment comparison between BTDS 5 and oxycodone immediate-release during the 12-week double-blind phase.|||0.1189|-0.8455|0.140
70963805|NCT00312221|141432637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.007|TWO_SIDED|95.0|-1.47|-0.2|||ANCOVA||Treatment comparison between BTDS 5 and BTDS 20 during the 12-week double-blind phase.|||-0.20|-1.47|0.007
70963806|NCT00312221|141432637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.011|TWO_SIDED|95.0|-1.47|-0.17|||ANCOVA||Treatment comparison between BTDS 5 and oxycodone immediate-release during the 12-week double-blind phase.|||-0.17|-1.47|0.011
70963807|NCT00312221|141432638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.707|TWO_SIDED|95.0|-3.0054|2.0397|||Mixed Models Analysis||Treatment comparison between BTDS 5 and BTDS 20 during the 12-week double-blind phase.|||2.0397|-3.0054|0.707
70963808|NCT00312221|141432638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.79||||0.187|TWO_SIDED|95.0|-4.4459|0.8706|||Mixed Models Analysis||Treatment comparison between BTDS 5 and oxycodone immediate-release during the 12-week double-blind phase.|||0.8706|-4.4459|0.187
70963809|NCT00312221|141432639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96||||0.685|TWO_SIDED|95.0|-5.6177|3.693|||Mixed Models Analysis||Treatment comparison between BTDS 5 and BTDS 20 during the 12-week double-blind phase.|||3.6930|-5.6177|0.685
70963810|NCT00312221|141432639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.81||||0.443|TWO_SIDED|95.0|-6.4415|2.8255|||Mixed Models Analysis||Treatment comparison between BTDS 5 and oxycodone immediate-release during the 12-week double-blind phase.|||2.8255|-6.4415|0.443
70963811|NCT00846885|141432686|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|110.0||||||90.0|103.0|117.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||117|103|
70963812|NCT00846885|141432687|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|106.0||||||90.0|102.0|111.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||111|102|
70963813|NCT00846885|141432688|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|105.0||||||90.0|101.0|110.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||110|101|
70963814|NCT01862640|141432689|SUPERIORITY||Least square (LS) mean difference|-3.77|||=|0.0404|TWO_SIDED|95.0|-7.38|-0.17|||Mixed-effect model repeated measure|||||-0.17|-7.38|=0.0404
70963815|NCT01862640|141432689|SUPERIORITY||LS mean difference|0.23|||=|0.9015|TWO_SIDED|95.0|-3.4|3.86|||Mixed-effect model repeated measure|||||3.86|-3.40|=0.9015
70963816|NCT01862640|141432690|SUPERIORITY||LS mean difference|-0.16|||=|0.1566|TWO_SIDED|95.0|-0.39|0.06|||Mixed-effect model repeated measure|||||0.06|-0.39|=0.1566
70963817|NCT01862640|141432690|SUPERIORITY||LS mean difference|0.09|||=|0.444|TWO_SIDED|95.0|-0.14|0.32|||Mixed-effect model repeated measure|||||0.32|-0.14|=0.4440
70963818|NCT04884763|141432692|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.567|TWO_SIDED|95.0|-0.76|1.35||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.35|-0.76|0.567
70963819|NCT04884763|141432693|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.778|TWO_SIDED|95.0|-0.91|1.21||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.21|-0.91|0.778
70963820|NCT04884763|141432694|SUPERIORITY||Mean Difference (Final Values)|0.88||||0.105|TWO_SIDED|95.0|-0.2|1.96||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.96|-0.20|0.105
70963821|NCT04884763|141432695|SUPERIORITY||Mean Difference (Final Values)|17.5||||0.163|TWO_SIDED|95.0|-7.6|42.7||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||42.7|-7.6|0.163
70963822|NCT04884763|141432696|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.91|TWO_SIDED|95.0|-1.13|1.01||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.01|-1.13|0.910
70963823|NCT04884763|141432697|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.972|TWO_SIDED|95.0|-0.83|0.8||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||0.80|-0.83|0.972
70963824|NCT04884763|141432698|SUPERIORITY||Mean Difference (Final Values)|2.81||||0.037|TWO_SIDED|95.0|0.18|5.43||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||5.43|0.18|0.037
70963825|NCT04884763|141432699|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.885|TWO_SIDED|95.0|-3.95|3.43||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||3.43|-3.95|0.885
70963826|NCT04884763|141432700|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.474|TWO_SIDED|95.0|-0.87|1.81||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.81|-0.87|0.474
70963827|NCT04884763|141432701|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.822|TWO_SIDED|95.0|-1.94|1.56||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.56|-1.94|0.822
70963828|NCT04884763|141432702|SUPERIORITY||Mean Difference (Final Values)|0.51||||0.455|TWO_SIDED|95.0|-0.88|1.91||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.91|-0.88|0.455
70963829|NCT04884763|141432703|SUPERIORITY||Mean Difference (Final Values)|7.1||||0.467|TWO_SIDED|95.0|-12.8|27.0||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||27.0|-12.8|0.467
70963830|NCT04884763|141432704|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.755|TWO_SIDED|95.0|-0.79|1.07||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.07|-0.79|0.755
70963831|NCT04884763|141432705|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.613|TWO_SIDED|95.0|-1.18|0.71||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||0.71|-1.18|0.613
70963832|NCT04884763|141432706|SUPERIORITY||Mean Difference (Final Values)|2.58||||0.003|TWO_SIDED|95.0|0.94|4.22||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||4.22|0.94|0.003
70963833|NCT04884763|141432707|SUPERIORITY||Mean Difference (Final Values)|1.19||||0.536|TWO_SIDED|95.0|-2.7|5.08||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||5.08|-2.70|0.536
70963834|NCT02178553|141432708|NON_INFERIORITY|We determined that a difference of 1 unit between groups would be the bound for non-inferiorty.|Confidence Interval|1.0||||0.142|TWO_SIDED|90.0|-0.1|1.8|||t-test, 2 sided|||||1.8|-0.1|0.142
70963835|NCT02178553|141432709|NON_INFERIORITY|We determined that a difference of 1 unit between groups would be the bound for non-inferiorty.|Confidence Interval|1.0||||0.101|TWO_SIDED|90.0|0.4|1.9|||t-test, 2 sided|||||1.9|0.4|0.101
70963836|NCT02178553|141432710|NON_INFERIORITY|We determined that a difference of 1 unit between groups would be the bound for non-inferiorty.|Confidence Interval|1.0||||0.014|TWO_SIDED|90.0|0.4|1.9|||t-test, 2 sided|||||1.9|0.4|0.014
70963837|NCT02178553|141432711|NON_INFERIORITY|We determined that a difference of 1 unit between groups would be the bound for non-inferiorty.|Confidence Interval|1.0||||0.375|TWO_SIDED|90.0|-0.3|1.0|||t-test, 2 sided|||||1.0|-0.3|0.375
70963838|NCT00778622|141432768|SUPERIORITY_OR_OTHER|||||||0.0806||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in HbA1c at Week 16 was dependent variable, BMI was fixed main effect, baseline HbA1c was covariate.||"Standard deviation assumed for changes from baseline in HbA1c maximally was 1.0 across the baseline BMI subgroups. 97 participants in a single subgroup would be sufficient to estimate mean change in HbA1c with precision of 0.20% within the subgroup. Given number of baseline BMI subgroups and no correction for reason of multiplicity was made to the 95% CI within each BMI subgroup, total sample size calculated as 291. Sample size used the method CI for mean for one group in nQuery Advisor v6.0."||||0.0806
70963839|NCT00778622|141432768|SUPERIORITY_OR_OTHER|||||||0.1984||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided|||||||0.1984
70963840|NCT00778622|141432768|SUPERIORITY_OR_OTHER|||||||0.0232||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided|||||||0.0232
70963841|NCT00778622|141432768|SUPERIORITY_OR_OTHER|||||||0.3589||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided|||||||0.3589
70963842|NCT00778622|141432769|SUPERIORITY_OR_OTHER|||||||0.4614||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in FPG at Week 16 was dependent variable, BMI was fixed main effect, baseline FPG was covariate.||||||0.4614
70963843|NCT00778622|141432769|SUPERIORITY_OR_OTHER|||||||0.4696||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided|||||||0.4696
70963844|NCT00778622|141432769|SUPERIORITY_OR_OTHER|||||||0.5305||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided|||||||0.5305
70963845|NCT00778622|141432769|SUPERIORITY_OR_OTHER|||||||0.9145||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided|||||||0.9145
70963846|NCT00778622|141432770|SUPERIORITY_OR_OTHER|||||||0.0305||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in TC at Week 16 was dependent variable, BMI was fixed main effect, baseline TC was covariate.||||||0.0305
70963847|NCT00778622|141432770|SUPERIORITY_OR_OTHER|||||||0.008||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.0080
70963848|NCT00778622|141432770|SUPERIORITY_OR_OTHER|||||||0.0422||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.0422
70963849|NCT00778622|141432771|SUPERIORITY_OR_OTHER|||||||0.4508||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in LDL-C at Week 16 was dependent variable, BMI was fixed main effect, baseline LDL-C was covariate.||||||0.4508
70963850|NCT00778622|141432771|SUPERIORITY_OR_OTHER|||||||0.0526||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.0526
70963851|NCT00778622|141432771|SUPERIORITY_OR_OTHER|||||||0.1295||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.1295
70963852|NCT00778622|141432772|SUPERIORITY_OR_OTHER|||||||0.1431||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in HDL-C at Week 16 was dependent variable, BMI was fixed main effect, baseline HDL-C was covariate.||||||0.1431
70963853|NCT00778622|141432772|SUPERIORITY_OR_OTHER|||||||0.4066||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.4066
70963854|NCT00778622|141432772|SUPERIORITY_OR_OTHER|||||||0.4071||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.4071
70963855|NCT00778622|141432773|SUPERIORITY_OR_OTHER|||||||0.021||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in TG at Week 16 was dependent variable, BMI was fixed main effect, baseline TG was covariate.||||||0.0210
70963856|NCT00778622|141432773|SUPERIORITY_OR_OTHER|||||||0.2507||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.2507
70963857|NCT00778622|141432773|SUPERIORITY_OR_OTHER|||||||0.6546||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.6546
70963858|NCT01505010|141432784|SUPERIORITY||Mean Difference (Final Values)|22.4|STANDARD_ERROR_OF_MEAN|8.5||0.018|TWO_SIDED||||||Mixed Models Analysis|Adjusted for the baseline 24-h systolic blood pressure|Difference at 6 months in 24-h systolic blood pressure (control minus intervention)|We used mixed models to compare blood pressure changes between randomized groups at 6 months, while adjusting for the baseline blood pressure; statistical significance was a P-value less than 0.05 on two-sided tests.||||0.018
70963859|NCT01505010|141432785|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.5|STANDARD_ERROR_OF_MEAN|4.87||0.86|TWO_SIDED||||||t-test, 2 sided|||Difference between control and intervention group at 6 months||||0.86
70963860|NCT01505010|141432786|SUPERIORITY||Median Difference (Final Values)|1.7||||0.032|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Wilcocon rank sum test||||0.032
70963861|NCT01505010|141432786|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|0.8||0.032|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.032
70963862|NCT02558231|141432791|SUPERIORITY||Ratio of geometric Least Square mean|0.96||||0.4239|TWO_SIDED|95.0|0.86|1.07|||ANCOVA|||||1.07|0.86|0.4239
70963863|NCT02558231|141432792|SUPERIORITY||Least Square (LS) Mean difference|-1.43||||0.8758|TWO_SIDED|95.0|-19.393|16.538|||ANCOVA|||||16.538|-19.393|0.8758
70963864|NCT02558231|141432793|SUPERIORITY||Ratio of geometric LS mean|1.03||||0.8529|TWO_SIDED|95.0|0.77|1.371|||ANCOVA|||||1.371|0.770|0.8529
70963865|NCT02558231|141432795|SUPERIORITY||LS Mean Difference|-0.72||||0.4998|TWO_SIDED|95.0|-2.834|1.386|||ANCOVA|||||1.386|-2.834|0.4998
70963866|NCT02558231|141432796|SUPERIORITY||LS Mean Difference|-0.09||||0.8528|TWO_SIDED|95.0|-1.003|0.83|||ANCOVA|||||0.830|-1.003|0.8528
70963867|NCT02558231|141432797|SUPERIORITY||LS Mean Difference|2.4||||0.9474|TWO_SIDED|95.0|-69.368|74.178|||ANCOVA|||||74.178|-69.368|0.9474
70963868|NCT02558231|141432798|SUPERIORITY||LS Mean Difference|0.13||||0.1902|TWO_SIDED|95.0|-0.066|0.328|||ANCOVA|||||0.328|-0.066|0.1902
70963869|NCT02558231|141432799|SUPERIORITY||LS Mean Difference|-1.2||||0.1227|TWO_SIDED|95.0|-2.737|0.327|||ANCOVA|||||0.327|-2.737|0.1227
70963870|NCT02558231|141432800|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.0867|TWO_SIDED|95.0|0.32|1.09|||Log Rank|||||1.09|0.32|0.0867
70963871|NCT04029961|141432866|OTHER|Multivariate regression model and intra-arm differences in measure scores between time points.|||||<|0.05||||||Multivariate regression was adjusted for covariates of study site, highest education level, prior chemotherapy, age, \& T stage. Random effects was adjusted for multiple measurements. Multiplicity corrections were conducted via Holm-Sidak method.|multivariate regression|||||||<0.05
70963872|NCT04029961|141432867|OTHER|Multivariate regression model and intra-arm differences in measure scores between time points.|||||<|0.05||||||Multivariate regression was adjusted for covariates of study site, highest education level, prior chemotherapy, age, \& T stage. Random effects was adjusted for multiple measurements. Multiplicity corrections were conducted via Holm-Sidak method.|multivariate regression|||||||<0.05
70963873|NCT04029961|141432868|OTHER|Multivariate regression model and intra-arm differences in measure scores between time points.|||||<|0.05||||||Multivariate regression was adjusted for covariates of study site, highest education level, prior chemotherapy, age, \& T stage. Random effects was adjusted for multiple measurements. Multiplicity corrections were conducted via Holm-Sidak method.|multivariate regression|||||||<0.05
70963874|NCT04029961|141432869|OTHER|Multivariate regression model and intra-arm differences in measure scores between time points.|||||<|0.05||||||Multivariate regression was adjusted for covariates of study site, highest education level, prior chemotherapy, age, \& T stage. Random effects was adjusted for multiple measurements. Multiplicity corrections were conducted via Holm-Sidak method.|multivariate regression|||||||<0.05
70963875|NCT04029961|141432870|OTHER|"A univariate analysis comparing the proportion of each arm that indicated an item was met, evaluated for each item at each time point."|||||<|0.05|||||||Univariate analysis|||"The statistical test described below was only performed on the top 10 items on the scale rated the highest in importance by participants. The top 10 items were determined by computing the mean rating for each item (participants gave each item a rating from '1' - '9' with higher values representing greater importance) and selecting the 10 items with the largest mean values, excluding the item the radiation oncologist who will be treating me as that item was not addressed in either intervention."||||<0.05
70963876|NCT03427125|141432871|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
70963877|NCT03427125|141432872|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.0020
70963878|NCT05315947|141432933|EQUIVALENCE|Bioequivalence between the BRV tablet (reference) and BRV dry syrup (test) formulations were concluded if the 90% CI limits for Cmax was within the 0.80 to 1.25 range.|Ratio of Dry Syrup/ Tablet|0.87|||||TWO_SIDED|90.0|0.7814|0.9686||||||||0.9686|0.7814|
70963879|NCT05315947|141432934|EQUIVALENCE|Bioequivalence between the BRV tablet (reference) and BRV dry syrup (test) formulations were concluded if the 90% CI limits for AUC(0-t) was within the 0.80 to 1.25 range.|Ratio of Dry Syrup/ Tablet|0.989|||||TWO_SIDED|90.0|0.9756|1.003||||||||1.003|0.9756|
70963880|NCT04252287|141432937|SUPERIORITY||LS mean difference|4.3||||0.016|TWO_SIDED|95.0|0.8|7.8|||ANCOVA|||||7.8|0.8|0.016
70963881|NCT04252287|141432938|SUPERIORITY||LS mean difference|29.8||||0.852|TWO_SIDED|95.0|-284.4|344.1|||ANCOVA|||||344.1|-284.4|0.852
70963882|NCT03610165|141432944|SUPERIORITY||Median Difference (Final Values)|0.0||||0.757|TWO_SIDED|95.0|-0.03|0.04|||Wilcoxon (Mann-Whitney)|||||0.04|-0.03|0.757
70963883|NCT03610165|141432945|SUPERIORITY||Median Difference (Final Values)|-1.3||||0.715|TWO_SIDED|95.0|-12.0|7.0|||Wilcoxon (Mann-Whitney)|||||7|-12|0.715
70963884|NCT03610165|141432946|SUPERIORITY||Median Difference (Final Values)|-1.0||||0.328|TWO_SIDED|95.0|-3.3|1.0|||Wilcoxon (Mann-Whitney)|||||1|-3.3|0.328
70963885|NCT03610165|141432947|SUPERIORITY||Median Difference (Final Values)|0.0||||0.376|TWO_SIDED|95.0|-0.001|0.011|||Wilcoxon (Mann-Whitney)|||||0.011|-0.001|0.376
70963886|NCT03610165|141432948|SUPERIORITY||Median Difference (Final Values)|0.0||||0.226|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.226
70963887|NCT03610165|141432949|SUPERIORITY||Median Difference (Final Values)|0.0||||0.61|TWO_SIDED|95.0|-0.67|2.0|||Wilcoxon (Mann-Whitney)|||||2.00|-0.67|0.610
70963888|NCT03610165|141432950|SUPERIORITY||Median Difference (Final Values)|0.0||||0.302|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.302
70963889|NCT03610165|141432951|SUPERIORITY||Median Difference (Final Values)|0.0||||0.889|TWO_SIDED|95.0|-0.67|0.67|||Wilcoxon (Mann-Whitney)|||||0.67|-0.67|0.889
70963890|NCT03610165|141432952|SUPERIORITY||Median Difference (Final Values)|0.0||||0.403|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.403
70963891|NCT04667247|141432957|OTHER||ratio of frequencies|0.94||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.000
70963892|NCT04667247|141432960|OTHER||ratio of frequencies|1.022||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.000
70963893|NCT04667247|141432962|OTHER||ratio of frequencies|4.828||||0.061|TWO_SIDED||||||Chi-squared, Corrected|||||||0.061
70963894|NCT04667247|141432963|OTHER||ratio of frequencies|3.526||||0.1|TWO_SIDED||||||Chi-squared, Corrected|||||||.100
70963895|NCT04667247|141432964|OTHER||ratio of frequencies|0.005||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.000
70963896|NCT04667247|141432965|OTHER||ratio of frequencies|3.036||||0.162|TWO_SIDED||||||Chi-squared, Corrected|||||||.162
70963897|NCT04667247|141432967|OTHER||ratio of frequencies|0.151||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.00
70963898|NCT04667247|141432968|SUPERIORITY||F value|1.908||||0.174|TWO_SIDED||||||Mixed Models Analysis||Group by Day interaction|||||.174
70963899|NCT04667247|141432969|SUPERIORITY||F value|0.038||||0.846|TWO_SIDED||||||Mixed Models Analysis||Group by Day interaction|||||.846
70963900|NCT04667247|141432970|SUPERIORITY||F value|0.041||||0.841|TWO_SIDED||||||Mixed Models Analysis||Day by Group interaction|||||.841
70963901|NCT04667247|141432971|SUPERIORITY||F value|0.261||||0.612|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.612
70963902|NCT04667247|141432972|SUPERIORITY||F value|0.161||||0.69|TWO_SIDED||||||Mixed Models Analysis||Group by Day interaction|||||.690
70963903|NCT04667247|141432973|SUPERIORITY||F value|2.671||||0.109|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.109
70963904|NCT04667247|141432974|SUPERIORITY||F value|0.039||||0.844|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.844
70963905|NCT04667247|141432975|SUPERIORITY||F value|4.28||||0.044|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.044
70963906|NCT04667247|141432976|SUPERIORITY||F value|0.001||||0.989|TWO_SIDED||||||Mixed Models Analysis||Day by Group interaction|||||.989
70963907|NCT04667247|141432977|SUPERIORITY||F value|7.186||||0.01|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.010
70963908|NCT04667247|141432978|SUPERIORITY||F value|0.345||||0.56|TWO_SIDED||||||Mixed Models Analysis||Group by Day interaction|||||.560
70963909|NCT04667247|141432979|SUPERIORITY||F value|0.143||||0.707|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.707
70963910|NCT04667247|141432980|SUPERIORITY||F value|0.09||||0.765|TWO_SIDED||||||Mixed Models Analysis||Day by Group interaction|||||0.765
70963911|NCT04667247|141432981|SUPERIORITY||F value|7.835||||0.005|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.005
70963912|NCT04667247|141432982|SUPERIORITY||F value|16.56|||<|0.001|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||<0.001
70963913|NCT01444651|141432996|SUPERIORITY_OR_OTHER||beta estimate|-1.25|STANDARD_ERROR_OF_MEAN|1.29||0.34|TWO_SIDED||||||Regression, Linear|||Linear regression was used to model the change in HOMA-IR (3 month minus baseline value), comparing tadalafil versus placebo groups after adjusting for baseline HOMA-IR.||||0.34
70963914|NCT01444651|141432997|SUPERIORITY_OR_OTHER||beta estimate|0.96|STANDARD_ERROR_OF_MEAN|0.68||0.18|TWO_SIDED||||||Regression, Linear|||Linear regression was used to model the change in Matsuda Index (3-month minus baseline), comparing tadalafil versus placebo groups after adjusting for baseline value.||||0.18
70963915|NCT01444651|141432998|SUPERIORITY_OR_OTHER||beta estimate|-0.18|STANDARD_ERROR_OF_MEAN|0.58||0.76|TWO_SIDED||||||Regression, Linear|||Linear regression was used to model the difference in EndoPAT (3-month minus baseline), comparing tadalafil to placebo groups after adjusting for baseline values.||||0.76
70963916|NCT01444651|141432999|SUPERIORITY_OR_OTHER||beta estimate|1.48|STANDARD_ERROR_OF_MEAN|0.77||0.06|TWO_SIDED||||||Regression, Linear|||Linear regression was used to model the change in insulinogenic index (3-month minus baseline), comparing tadalafil to placebo groups after adjusting for baseline value.||||0.06
70963917|NCT01444651|141433000|SUPERIORITY_OR_OTHER||beta estimate|3.76|STANDARD_ERROR_OF_MEAN|1.38||0.009|TWO_SIDED||||||Regression, Linear|||Linear regression was used to model the change in oral disposition index (3-month minus baseline), comparing tadalafil versus placebo groups after adjusting for baseline value.||||0.009
70963918|NCT01444651|141433001|SUPERIORITY_OR_OTHER||beta estimate|8.09|STANDARD_ERROR_OF_MEAN|4.05||0.05|TWO_SIDED||||||Regression, Linear|||Linear regression was used to model the change in Matsuda disposition index (3-month minus baseline), comparing tadalafil to placebo groups after adjusting for baseline value.||||0.05
70963919|NCT03383289|141433009|SUPERIORITY||Beta estimate of the percent who fell|0.118|STANDARD_ERROR_OF_MEAN|0.145||0.417|TWO_SIDED||||||Mixed Models Analysis|MIANALYZE was used to model missing data. Models were adjusted for the design effects of clustering.||||||0.4170
70963920|NCT03383289|141433011|OTHER|paired t test|Mean Difference (Final Values)|-1.353|STANDARD_ERROR_OF_MEAN|0.181|<|0.001|TWO_SIDED|95.0|-1.708|-0.998|||paired t test|||Analysis of adjusted mean differences using a paired t test procedure||-0.998|-1.708|<0.001
70963921|NCT03383289|141433012|SUPERIORITY||Beta|0.6364|STANDARD_ERROR_OF_MEAN|0.233||0.0064|TWO_SIDED|95.0|0.1797|1.0931|||Poisson regression|||||1.0931|0.1797|0.0064
70963922|NCT03383289|141433012|SUPERIORITY||Estimated log mean|-4.0168||||0.001|TWO_SIDED|95.0|-5.5827|-2.4509|||Poisson regression|||||-2.4509|-5.5827|0.001
70963923|NCT03383289|141433013|OTHER|adjusted mean differences from paired t tests|Mean Difference (Final Values)|-0.456|STANDARD_ERROR_OF_MEAN|0.162||0.005|TWO_SIDED|95.0|-0.774|-0.138|||paired t test|||||-0.138|-0.774|0.005
70963924|NCT03829241|141433157|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.7||0.917|TWO_SIDED|95.0|-1.45|1.3|||Mixed Models Analysis|||Model-based summary statistics are from a mixed model with repeated measures, including fixed effects for treatment, visit, treatment-by-visit interaction, baseline score, baseline score-by-visit interaction as covariates, and participant as random effect.||1.30|-1.45|0.917
70963925|NCT00698451|141433163|SUPERIORITY_OR_OTHER||Percentage|72.2||||0.05|TWO_SIDED|95.0|58.4|83.5|||Exact Binomial Distribution|||||83.5|58.4|0.05
70963926|NCT00733304|141433189|SUPERIORITY||Mean Difference (Net)|-0.43|STANDARD_ERROR_OF_MEAN|1.362|||TWO_SIDED|95.0|-3.18|2.31||Analysis of covariance (ANCOVA) model was used to perform statistical analysis based on treatment, visit, fixed effect terms etc.|ANCOVA|||Month 2 versus screening visit||2.31|-3.18|
70963927|NCT00733304|141433189|SUPERIORITY||Mean Difference (Net)|-3.8|STANDARD_ERROR_OF_MEAN|1.659|||TWO_SIDED|95.0|-7.13|-0.46||Analysis of covariance (ANCOVA) model was used to perform statistical analysis based on treatment, visit, fixed effect terms etc.|ANCOVA|||Month 5 versus screening visit||-0.46|-7.13|
70963928|NCT00733304|141433189|SUPERIORITY||Mean Difference (Net)|-4.15|STANDARD_ERROR_OF_MEAN|1.672|||TWO_SIDED|95.0|-7.52|-0.78||Analysis of covariance (ANCOVA) model was used to perform statistical analysis based on treatment, visit, fixed effect terms etc.|ANCOVA|||Month 2 versus screening visit||-0.78|-7.52|
70963929|NCT00733304|141433189|SUPERIORITY||Mean Difference (Net)|-4.03|STANDARD_ERROR_OF_MEAN|1.74|||TWO_SIDED|95.0|-7.53|0.53||Analysis of covariance (ANCOVA) model was used to perform statistical analysis based on treatment, visit, fixed effect terms etc.|ANCOVA|||Month 5 versus screening visit||0.53|-7.53|
70963930|NCT00733304|141433190|SUPERIORITY||Mean Difference (Net)|8.28|STANDARD_ERROR_OF_MEAN|16.899|||TWO_SIDED|95.0|-25.72|42.29||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||For Month 1 versus Screening visit||42.29|-25.72|
70963931|NCT00733304|141433190|SUPERIORITY||Mean Difference (Net)|-1.21|STANDARD_ERROR_OF_MEAN|17.177|||TWO_SIDED|95.0|-35.73|33.31||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 2 versus Screening visit||33.31|-35.73|
70963932|NCT00733304|141433190|SUPERIORITY||Mean Difference (Net)|-5.11|STANDARD_ERROR_OF_MEAN|17.958|||TWO_SIDED|95.0|-41.08|30.86||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 3 versus Screening visit||30.86|-41.08|
70963933|NCT00733304|141433190|SUPERIORITY||Mean Difference (Net)|-9.92|STANDARD_ERROR_OF_MEAN|18.996|||TWO_SIDED|95.0|-47.83|28.0||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 4 versus Screening visit||28.00|-47.83|
70963934|NCT00733304|141433190|SUPERIORITY||Mean Difference (Net)|2.42|STANDARD_ERROR_OF_MEAN|18.996|||TWO_SIDED|95.0|-35.5|40.33||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 5 versus Screening visit||40.33|-35.50|
70963935|NCT00733304|141433190|SUPERIORITY||Mean Difference (Net)|9.05|STANDARD_ERROR_OF_MEAN|20.931|||TWO_SIDED|95.0|-33.09|51.2||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 1 versus Screening visit||51.20|-33.09|
70963936|NCT00733304|141433190|SUPERIORITY||Mean Difference (Net)|-1.24|STANDARD_ERROR_OF_MEAN|21.29|||TWO_SIDED|95.0|-44.05|41.57||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 2 versus Screening visit||41.57|-44.05|
70963937|NCT00733304|141433190|SUPERIORITY||Mean Difference (Net)|15.39|STANDARD_ERROR_OF_MEAN|21.757|||TWO_SIDED|95.0|-28.28|59.06||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 3 versus Screening visit||59.06|-28.28|
70963938|NCT00733304|141433190|SUPERIORITY||Mean Difference (Net)|-16.82|STANDARD_ERROR_OF_MEAN|22.183|||TWO_SIDED|95.0|-61.28|27.63||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 4 versus Screening visit||27.63|-61.28|
70963939|NCT00733304|141433190|SUPERIORITY||Mean Difference (Net)|-2.16|STANDARD_ERROR_OF_MEAN|21.757|||TWO_SIDED|95.0|-45.83|41.51||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 5 versus Screening visit||41.51|-45.83|
70963940|NCT01187550|141433193|SUPERIORITY_OR_OTHER|||||||0.194||95.0|||||Wilcoxon rank sum test|||||||0.194
70963941|NCT01187550|141433194|SUPERIORITY_OR_OTHER|||||||0.752||95.0|||||Wilcoxon rank sum test|||||||0.752
70963942|NCT01187550|141433195|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Wilcoxon rank sum test|||||||0.710
70963943|NCT01187550|141433196|SUPERIORITY_OR_OTHER|||||||0.265||95.0|||||Wilcoxon rank sum test|||||||0.265
70963944|NCT01187550|141433197|SUPERIORITY_OR_OTHER|||||||0.308||95.0|||||Wilcoxon rank sum test|||||||0.308
70963945|NCT01187550|141433198|SUPERIORITY_OR_OTHER|||||||0.078||95.0|||||Wilcoxon rank sum test|||For total cholesterol: Wilcoxon rank sum test was used to calculate p-value.||||0.078
70903437|NCT00576732|141295321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|2.18|<|0.001|TWO_SIDED|95.0|-12.19|-3.52||Type I error is preserved by the step down procedure, no multiple comparison adjustment is needed. A priori threshold for statistical significance was 0.05.|ANCOVA|ANCOVA model included factors for treatment group, center (after pooling of small centers), baseline weight stratification, and baseline ABC-I value|Mean difference is change in Risperidone high dose arm minus change in placebo arm.|"A step-down testing procedure was employed with the risperidone high dose versus placebo comparison tested first. If this comparison was significant the risperidone low dose versus placebo comparison would be performed.~A clinically relevant difference in the change from baseline on the ABC Irritability subscale was assumed to be 6 with a standard deviation of 8. To achieve 80% power with Type I error rate of 5%, 93 subjects were required."||-3.52|-12.19|<0.001
70903438|NCT00576732|141295321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|2.17||0.164|TWO_SIDED|95.0|-7.36|1.27||Type I error is preserved by the step down procedure, no multiple comparison adjustment is needed. A priori threshold for statistical significance was 0.05.|ANCOVA|ANCOVA model included factors for treatment group, center (after pooling of small centers), baseline weight stratification, and baseline ABC-I value|Mean difference is change in Risperidone low dose arm minus change in placebo arm.|||1.27|-7.36|0.164
70903439|NCT00576732|141295322|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value is not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for center (after pooling small centers) and baseline weight stratification.||||||0.004
70903440|NCT00576732|141295322|SUPERIORITY_OR_OTHER|||||||0.817||95.0||||P-value is not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for center (after pooling small centers) and baseline weight stratification.||||||0.817
70903441|NCT00576732|141295323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.02|-0.33||P-value is not adjusted for multiple comparisons.|ANCOVA|ANCOVA model included factors for treatment group, center (after pooling of small centers), baseline weight stratification, and baseline CGI-S value.|Mean difference is change in Risperidone high dose arm minus change in placebo arm.|||-0.33|-1.02|<0.001
70903442|NCT00576732|141295323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.769|TWO_SIDED|95.0|-0.39|0.29||P-value is not adjusted for multiple comparisons.|ANCOVA|ANCOVA model included factors for treatment group, center (after pooling of small centers), baseline weight stratification, and baseline CGI-S value|Mean difference is change in Risperidone low dose arm minus change in placebo arm.|||0.29|-0.39|0.769
70903443|NCT00576732|141295324|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for center (after pooling small centers) and baseline weight stratification.||||||<0.001
70903444|NCT00576732|141295324|SUPERIORITY_OR_OTHER|||||||0.985||95.0||||P-value is not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for center (after pooling small centers) and baseline weight stratification.||||||0.985
70903445|NCT05096208|141295331|EQUIVALENCE|Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously.|Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.858|1.169|||||GMRs and 2-sided CIs were calculated by exponentiating the difference in least-square (LS) means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model.|RSV A||1.169|0.858|
70903446|NCT05096208|141295331|EQUIVALENCE|Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously.|Geometric Mean Ratio|1.05|||||TWO_SIDED|95.0|0.9|1.215|||||GMRs and 2-sided CIs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model.|RSV A||1.215|0.900|
70903447|NCT05096208|141295331|EQUIVALENCE|Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously.|Geometric Mean Ratio|1.04|||||TWO_SIDED|95.0|0.886|1.232|||||GMRs and 2-sided CIs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model.|RSV A||1.232|0.886|
70903448|NCT05096208|141295331|EQUIVALENCE|Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously.|Geometric Mean Ratio|1.07|||||TWO_SIDED|95.0|0.905|1.261|||||GMRs and 2-sided CIs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model.|RSV B||1.261|0.905|
70903449|NCT05096208|141295331|EQUIVALENCE|Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously.|Geometric Mean Ratio|1.13|||||TWO_SIDED|95.0|0.953|1.336|||||GMRs and 2-sided CIs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model.|RSV B||1.336|0.953|
70963946|NCT01187550|141433198|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Wilcoxon rank sum test|||For HDL-cholesterol: Wilcoxon rank sum test was used to calculate p-value.||||0.033
70963947|NCT01187550|141433198|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||Wilcoxon rank sum test|||For LDL-cholesterol: Wilcoxon rank sum test was used to calculate p-value.||||0.041
70963948|NCT01187550|141433198|SUPERIORITY_OR_OTHER|||||||0.091||95.0|||||Wilcoxon rank sum test|||For triglycerides: Wilcoxon rank sum test was used to calculate p-value.||||0.091
70963949|NCT02616614|141433207|EQUIVALENCE|Bioequivalence was established if the 90% CI for the difference was contained within the interval \[0.80,1.25\] for the PP population.|Mean Difference (Net)|0.95|||||TWO_SIDED|90.0|0.88|1.03||||||||1.03|0.88|
70963950|NCT02616614|141433207|SUPERIORITY|||||||0.0001|||||||ANOVA|||||||0.0001
70903450|NCT05096208|141295331|EQUIVALENCE|Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously.|Geometric Mean Ratio|1.06|||||TWO_SIDED|95.0|0.884|1.262|||||GMRs and 2-sided CIs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model.|RSV B||1.262|0.884|
70903451|NCT01508013|141295351|SUPERIORITY_OR_OTHER|||||||0.633|||||||Mixed Models Analysis|||||||.633
70903452|NCT01508013|141295352|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||||||.001
70903453|NCT01508013|141295353|SUPERIORITY_OR_OTHER|||||||0.018|||||||Mixed Models Analysis|||||||.018
70903454|NCT01807650|141295368|SUPERIORITY_OR_OTHER||||||=|0.0232||||||2-sided, significance level = 0.05|t-test, 2 sided|||"All participants received both treatments and treatments were intra-individually compared.~Hypotheses tested: H0: δ = 0 and H1: δ ≠ 0 with δ being the difference in time to wound closure between treatments."||||=0.0232
70903455|NCT01807650|141295372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1|STANDARD_DEVIATION|17.8|=|0.0005|TWO_SIDED|95.0|2.7|9.4||Day 7|t-test, 2 sided||Mean difference in degree of epithelialization \[%\] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)|||9.4|2.7|=0.0005
70903456|NCT01807650|141295372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2|STANDARD_DEVIATION|16.9|=|0.0002|TWO_SIDED|95.0|3.0|9.4||Day 10|t-test, 2 sided||Mean difference in degree of epithelialization \[%\] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)|||9.4|3.0|=0.0002
70903457|NCT01807650|141295372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.6|STANDARD_DEVIATION|19.3|=|0.0028|TWO_SIDED|95.0|2.0|9.3||Day 14|t-test, 2 sided||Mean difference in degree of epithelialization \[%\] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)|||9.3|2.0|=0.0028
70903458|NCT01807650|141295372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9|STANDARD_DEVIATION|18.0|=|0.0009|TWO_SIDED|95.0|2.5|9.3||Day 18|t-test, 2 sided||Mean difference in degree of epithelialization \[%\] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)|||9.3|2.5|=0.0009
70903459|NCT01807650|141295372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.6|STANDARD_DEVIATION|15.8|=|0.0003|TWO_SIDED|95.0|2.6|8.6||Day 21|t-test, 2 sided||Mean difference in degree of epithelialization \[%\] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)|||8.6|2.6|=0.0003
70903460|NCT01807650|141295372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6|STANDARD_DEVIATION|15.1|=|0.0145|TWO_SIDED|95.0|0.7|6.4||Day 28|t-test, 2 sided||Mean difference in degree of epithelialization \[%\] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)|||6.4|0.7|=0.0145
70903461|NCT02969525|141295392|OTHER||Correlation statistic|4.6|||=|0.031|||||||Cochran-Mantel-Haenszel|||"Statistic and p-value were calculated using a Cochran-Mantel-Haenszel test (test for non-zero correlation statistic) based on modified ridit scores and including geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure as stratification factors.~The 160 loading dose arm was not considered in the dose-response because this is a mixed dose and the test is examining linear dose response."||||=0.031
70903462|NCT02969525|141295392|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|4.2|||=|0.032|TWO_SIDED|95.0|1.13|15.23||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Factor Necrosis (TNF) inhibitor exposure.||15.23|1.13|=0.032
70903463|NCT02969525|141295392|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|8.1|||=|0.001|TWO_SIDED|95.0|2.28|28.74||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Factor Necrosis (TNF) inhibitor exposure.||28.74|2.28|=0.001
70903464|NCT02969525|141295392|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|9.7|||<|0.001|TWO_SIDED|95.0|2.73|34.26||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Factor Necrosis (TNF) inhibitor exposure.||34.26|2.73|<0.001
70903465|NCT02969525|141295392|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|3.7|||=|0.051|TWO_SIDED|95.0|1.0|13.68||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Factor Necrosis (TNF) inhibitor exposure.||13.68|1.00|=0.051
70903466|NCT02969525|141295393|OTHER||Odds Ratio (OR)|4.6|||=|0.002|TWO_SIDED|95.0|1.73|12.39||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||12.39|1.73|=0.002
70903467|NCT02969525|141295393|OTHER||Odds Ratio (OR)|11.0|||<|0.001|TWO_SIDED|95.0|3.91|30.95||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||30.95|3.91|<0.001
70903468|NCT02969525|141295393|OTHER||Odds Ratio (OR)|6.2|||<|0.001|TWO_SIDED|95.0|2.31|16.84||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||16.84|2.31|<0.001
70903469|NCT02969525|141295393|OTHER||Odds Ratio (OR)|4.2|||=|0.004|TWO_SIDED|95.0|1.59|11.35||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||11.35|1.59|=0.004
70903470|NCT02969525|141295394|OTHER||Odds Ratio (OR)|2.4|||=|0.279|TWO_SIDED|95.0|0.5|11.31||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||11.31|0.50|=0.279
70903471|NCT02969525|141295394|OTHER||Odds Ratio (OR)|4.1|||=|0.065|TWO_SIDED|95.0|0.92|17.88||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||17.88|0.92|=0.065
70903472|NCT02969525|141295394|OTHER||Odds Ratio (OR)|7.5|||=|0.006|TWO_SIDED|95.0|1.77|31.28||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||31.28|1.77|=0.006
70903473|NCT02969525|141295394|OTHER||Odds Ratio (OR)|2.9|||=|0.172|TWO_SIDED|95.0|0.63|13.39||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||13.39|0.63|=0.172
70903474|NCT00524030|141295419|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wald Test|2-sided 95% adjusted confidence interval constructed using KM product limit estimation and Greenwood's formula for variance with continuity correction||Null hypothesis (H0): Exit rate greater than or equal to (≥)74%||||<0.001
70903475|NCT00524030|141295419|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wald Test|2-sided 95% adjusted confidence interval constructed using KM product limit estimation and Greenwood's formula for variance with continuity correction||H0: Exite rate ≥68%||||<0.001
70903476|NCT00524030|141295420|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wald test|2-sided 95% adjusted confidence interval constructed using KM product limit estimation and Greenwood's formula for variance with continuity correction||H0: Exit rate ≥74%||||<0.001
70903477|NCT00524030|141295420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||Wald test|2-sided 95% adjusted confidence interval constructed using KM product limit estimation and Greenwood's formula for variance with continuity correction||H0: Exit rate ≥68%||||0.001
70903478|NCT00981474|141295460|SUPERIORITY||Risk Ratio (RR)|0.96||||0.752|TWO_SIDED|95.0|0.82|1.121|||Chi-squared|||||1.121|.82|.752
70903479|NCT00981474|141295461|SUPERIORITY||Risk Ratio (RR)|0.55||||0.053|TWO_SIDED|95.0|0.32|0.93|||Chi-squared|||||.93|.32|.053
70903480|NCT00981474|141295462|SUPERIORITY||Risk Ratio (RR)|0.454||||0.149|TWO_SIDED|95.0|0.18|1.17|||Chi-squared|||||1.17|.18|.149
70903481|NCT00981474|141295463|SUPERIORITY||Hazard Ratio (HR)|0.581||||0.144|TWO_SIDED|95.0|0.3|1.13|||Chi-squared|||||1.13|.30|.144
70903482|NCT00981474|141295464|SUPERIORITY||Risk Ratio (RR)|0.724||||0.439|TWO_SIDED|95.0|0.37|1.41|||Chi-squared|||||1.41|.37|.439
70903483|NCT00981474|141295465|SUPERIORITY||Risk Ratio (RR)|0.872||||0.311|TWO_SIDED|95.0|0.69|1.11|||Chi-squared|||||1.11|.69|.311
70903484|NCT00981474|141295466|SUPERIORITY||Risk Ratio (RR)|0.247||||0.103|TWO_SIDED|95.0|0.005|1.18|||Fisher Exact|Fisher exact test used due to the small number of events.||||1.18|.005|.103
70903485|NCT00981474|141295467|SUPERIORITY||Risk Ratio (RR)|1.102||||0.608|TWO_SIDED|95.0|0.81|1.5|||Chi-squared|||||1.5|.81|.608
70903486|NCT00981474|141295468|SUPERIORITY||Risk Ratio (RR)|0.564||||0.541|TWO_SIDED|95.0|0.16|1.97|||Fisher Exact|Fisher exact test used due to the small number of events.||||1.97|.16|.541
70903487|NCT00981474|141295469|SUPERIORITY||Risk Ratio (RR)|0.247||||0.103|TWO_SIDED|95.0|0.05|1.18|||Fisher Exact|Fisher exact test used due to small number of events.||||1.18|.05|.103
70903488|NCT00981474|141295470|SUPERIORITY||Risk Ratio (RR)|0.409||||0.129|TWO_SIDED|95.0|0.15|1.14|||Chi-squared|||||1.14|.15|.129
70903489|NCT00939731|141295471|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|92.61|||||TWO_SIDED|90.0|84.84|101.09||||||Natural log transformed AUClast of PF-02341066 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||101.09|84.84|
70903490|NCT00939731|141295474|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|92.43|||||TWO_SIDED|90.0|84.86|100.68||||||Natural log transformed AUC (0-∞) of PF-02341066 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||100.68|84.86|
70903491|NCT00939731|141295475|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|98.91|||||TWO_SIDED|90.0|90.18|108.48||||||Natural log transformed Cmax of PF-02341066 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CI for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||108.48|90.18|
70903492|NCT01213043|141295481|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin was: \[0.80, 1.25\]|Geometric Least Square Means Ratio|0.85|||<|0.0001|TWO_SIDED|90.0|0.83|0.88|||ANOVA|||Dose proportionality was analysed using an ANOVA model for the natural log-transformed AUC0-7days with treatment, period, and sequence as fixed effects and subject within sequence as a random effect. The treatment dose of 60 mg/kg was the reference treatment and 120 mg/kg was the test treatment. PK parameters in individual subjects for each treatment dose were dose normalized to 60mg/kg based on the actual dose administered at Week 8 or Week 18 (i.e., (AUC0-7days/Actual Dose in mg/kg)\*60mg/kg).||0.88|0.83|<0.0001
70903493|NCT01175148|141295496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.15|||<|0.05|TWO_SIDED||||||Fisher Exact|||The study used a minimax Simon two-stage design to test the null hypothesis Ho: P \> 0.35 versus the alternative H1: \< 0.15, where P is the probability of grade 2 to 4 acute GVHD at day + 100.||||<0.05
70903494|NCT01010477|141295497|SUPERIORITY_OR_OTHER|||||||0.632||||||threshold for statistical significance: p\< 0.05|Fisher Exact|||Fisher Exact test (2-sided)||||0.632
70903495|NCT02110732|141295498|OTHER|||||||0.05|||||||Fisher Exact|||||||0.05
70903496|NCT02110732|141295499|SUPERIORITY||||||<|0.05|||||||Chi-squared||||Categorical variables were analyzed with Chi-square test or Fisher's exact test. Comparisons between groups were by Levene's test for equality of variances. A P-level \<0.05 was considered statistically significant. Data were analyzed with SPSS v.19 and NCSS.|||< 0.05
70903497|NCT02110732|141295500|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||< 0.05
70903498|NCT01350141|141295511|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-21.81|STANDARD_ERROR_OF_MEAN|8.385||0.0137|TWO_SIDED|95.0|-38.85|-4.77|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with treatment, background statin as independent factors and treatment by background statin interaction, baseline LDL-C as covariate.||-4.77|-38.85|0.0137
70903499|NCT01350141|141295511|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.42|STANDARD_ERROR_OF_MEAN|8.463|<|0.0001|TWO_SIDED|95.0|-63.62|-29.22|||ANCOVA|||Analysis was performed using ANCOVA model with treatment, background statin as independent factors and treatment by background statin interaction, baseline LDL-C as covariate.||-29.22|-63.62|<0.0001
70903500|NCT01350141|141295512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.825||||0.19|TWO_SIDED|95.0|0.36|169.74|||Regression, Logistic|||Day 29 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||169.74|0.36|0.1900
70903501|NCT01350141|141295512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|72.518||||0.0057|TWO_SIDED|95.0|3.48|1512.1|||Regression, Logistic|||Day 29 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||1512.10|3.48|0.0057
70903502|NCT01350141|141295512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.75||||0.0013|TWO_SIDED|95.0|3.49|175.63|||Regression, Logistic|||Day 29 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||175.63|3.49|0.0013
70903503|NCT01350141|141295512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|47.326||||0.0006|TWO_SIDED|95.0|5.26|426.01|||Regression, Logistic|||Day 29 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||426.01|5.26|0.0006
70903504|NCT01350141|141295512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.635||||0.6611|TWO_SIDED|95.0|0.18|14.73|||Regression, Logistic|||Day 57 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||14.73|0.18|0.6611
70903505|NCT01350141|141295512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.486||||0.0104|TWO_SIDED|95.0|1.84|98.61|||Regression, Logistic|||Day 57 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||98.61|1.84|0.0104
70903506|NCT01350141|141295512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.43||||0.0282|TWO_SIDED|95.0|1.22|33.89|||Regression, Logistic|||Day 57 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||33.89|1.22|0.0282
70903507|NCT01350141|141295512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|15.257||||0.0042|TWO_SIDED|95.0|2.36|98.42|||Regression, Logistic|||Day 57 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||98.42|2.36|0.0042
70903508|NCT01350141|141295512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.967||||0.5164|TWO_SIDED|95.0|0.11|79.24|||Regression, Logistic|||Day 85 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||79.24|0.11|0.5164
70903509|NCT01350141|141295512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.36||||0.0445|TWO_SIDED|95.0|1.08|422.94|||Regression, Logistic|||Day 85 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||422.94|1.08|0.0445
70903510|NCT01350141|141295512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.157||||0.0223|TWO_SIDED|95.0|1.35|49.37|||Regression, Logistic|||Day 85 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||49.37|1.35|0.0223
70903511|NCT01350141|141295512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.587||||0.007|TWO_SIDED|95.0|2.04|90.4|||Regression, Logistic|||Day 85 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||90.40|2.04|0.0070
70963951|NCT02616614|141433207|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
70963952|NCT02616614|141433208|EQUIVALENCE|Bioequivalence was established if the 90% CI for the difference was contained within the interval \[0.80, 1.25\] for the PP population.|Mean Difference (Net)|1.0|||||TWO_SIDED|90.0|0.9|1.11||||||||1.11|0.90|
70963953|NCT02616614|141433208|SUPERIORITY|||||||0.0002|||||||ANOVA|||||||0.0002
70963954|NCT02616614|141433208|SUPERIORITY|||||||0.0006|||||||ANOVA|||||||0.0006
70963955|NCT02616614|141433209|EQUIVALENCE|Bioequivalence was established if the 90% CI for the difference was contained within the interval (-0.20, +0.20).|Mean Difference (Net)|-0.022|||||TWO_SIDED|90.0|-0.087|0.043|||||Equivalence was based on difference in the number of subjects with success. Bioequivalence was established if the 90% CI for the difference was contained within the interval (-0.20, +0.20).|Bioequivalence was established if the 90% CI for the difference was contained within the interval (-0.20, +0.20).||0.043|-0.087|
70963956|NCT00596934|141433210|SUPERIORITY_OR_OTHER|||||||0.015|||||||t-test, 2 sided|||Differences in each collected parameter will be evaluated using a paired t-test. If data are skewed such as in triglyceride levels, nonparametric tests will be used. P\<0.05 will be considered significant. If a significant difference can be demonstrated between baseline and 1-year results, a large scale, placebo-controlled trial will be designed using the data obtained from this pilot study||||0.015
70963957|NCT00596934|141433211|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70963958|NCT00596934|141433212|SUPERIORITY_OR_OTHER|||||||0.074||||||p = 0.074|t-test, 2 sided|||||||0.074
70963959|NCT00596934|141433213|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
70963960|NCT00596934|141433214|SUPERIORITY_OR_OTHER|||||||0.006|||||||t-test, 2 sided|||||||0.006
70963961|NCT00596934|141433215|SUPERIORITY_OR_OTHER|||||||0.023|||||||t-test, 2 sided|||||||0.023
70963962|NCT00596934|141433216|SUPERIORITY_OR_OTHER|||||||0.195||||||p-value = 0.195.|t-test, 2 sided|||||||0.195
70963963|NCT00596934|141433217|SUPERIORITY_OR_OTHER|||||||0.026|||||||t-test, 2 sided|||||||0.026
70963964|NCT03239483|141433219|SUPERIORITY|||||||0.072|||||||Fisher Exact|||two-sided Fisher's Exact Test||||0.072
70963965|NCT03239483|141433224|SUPERIORITY|||||||1||||||This is a calculated p-value. P-values of 1.0 are possible when using the Fisher Exact test method.|Fisher Exact|||||||1.00
70963966|NCT03239483|141433225|SUPERIORITY|||||||0.591|||||||Fisher Exact|||||||0.591
70963967|NCT00728481|141433226|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison between arms for a histologic response||||1.00
70963968|NCT00728481|141433231|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||Fisher Exact|||Comparison between arms for a symptomatic response||||0.76
70963969|NCT01807923|141433265|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|4.03|||<|0.0001|TWO_SIDED|95.0|2.62|5.44|||MMRM|||Analysis was performed using mixed-effects model for repeated measures (MMRM) model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (less than (\<)18 versus greater than equal to (\>=18) years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||5.44|2.62|<0.0001
70963970|NCT01807923|141433265|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6||||0.0003|TWO_SIDED|95.0|1.18|4.01|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||4.01|1.18|0.0003
70963971|NCT01807923|141433266|SUPERIORITY_OR_OTHER||LS Mean Difference|6.73|||<|0.0001|TWO_SIDED|95.0|4.27|9.19|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||9.19|4.27|<0.0001
70963972|NCT01807923|141433266|SUPERIORITY_OR_OTHER||LS Mean Difference|4.33||||0.0006|TWO_SIDED|95.0|1.86|6.8|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||6.80|1.86|0.0006
70963973|NCT01807923|141433267|SUPERIORITY_OR_OTHER||LS Mean Difference|0.16||||0.1122|TWO_SIDED|95.0|-0.04|0.35|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline BMI.||0.35|-0.04|0.1122
70963974|NCT01807923|141433267|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.1938|TWO_SIDED|95.0|-0.07|0.32|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||0.32|-0.07|0.1938
70963975|NCT01807923|141433268|SUPERIORITY_OR_OTHER||LS Mean Difference|3.88||||0.0168|TWO_SIDED|95.0|0.7|7.05||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline CFQ-R respiratory domain score.||7.05|0.70|0.0168
70963976|NCT01807923|141433268|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5||||0.3569|TWO_SIDED|95.0|-1.69|4.69|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||4.69|-1.69|0.3569
70963977|NCT01807923|141433269|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9378|||<|0.0001|TWO_SIDED|95.0|1.8786|4.5941||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Cochran-Mantel-Haenszel|||Odds Ratio (OR) and 95% confidence intervals (Cis) are Mantel-Haenszel estimates. P values are from a Cochran-Mantel-Haenszel test stratified by sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||4.5941|1.8786|<0.0001
70963978|NCT01807923|141433269|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0592||||0.0023|TWO_SIDED|95.0|1.292|3.2819||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Cochran-Mantel-Haenszel|||Analysis was performed as described in Statistical Analysis 1.||3.2819|1.2920|0.0023
70963979|NCT01807923|141433270|SUPERIORITY_OR_OTHER||Event Rate Ratio|0.7186||||0.0491|TWO_SIDED|95.0|0.517|0.9987|||Negative Binomial Regression|||Analysis was performed using regression analysis for a negative binomial distribution with sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70) as covariates with the logarithm of time on study as the offset.||0.9987|0.5170|0.0491
70963980|NCT01807923|141433270|SUPERIORITY_OR_OTHER||Event Rate Ratio|0.6643||||0.0169|TWO_SIDED|95.0|0.4749|0.9291||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Negative Binomial Regression|||Analysis was performed as described in Statistical Analysis 1.||0.9291|0.4749|0.0169
70963981|NCT01807923|141433271|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.1565|TWO_SIDED|95.0|-0.16|0.96|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline weight.||0.96|-0.16|0.1565
70963982|NCT01807923|141433271|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.2992|TWO_SIDED|95.0|-0.26|0.86|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||0.86|-0.26|0.2992
70963983|NCT01807923|141433272|SUPERIORITY_OR_OTHER||LS Mean Difference|0.098||||0.1539|TWO_SIDED|95.0|-0.037|0.233|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline BMI z-score.||0.2330|-0.0370|0.1539
70963984|NCT01807923|141433272|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0781||||0.2713|TWO_SIDED|95.0|-0.0615|0.2176|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||0.2176|-0.0615|0.2713
70963985|NCT01807923|141433273|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.692||||0.0396|TWO_SIDED||||||Cox Proportional Hazard Regression|||Analysis was performed using Cox proportional hazard regression, time is the time-to-first event or censoring, with adjustment for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||||0.0396
70963986|NCT01807923|141433273|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.691||||0.0385|TWO_SIDED||||||Cox Proportional Hazard Regression|||Analysis was performed as described in Statistical Analysis 1.||||0.0385
70963987|NCT01807923|141433274|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6565||||0.0552|TWO_SIDED|95.0|0.4266|1.0103|||Cochran-Mantel-Haenszel|||OR and 95% confidence intervals (CIs) are Mantel-Haenszel estimates. P values are from a Cochran-Mantel-Haenszel test stratified by sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||1.0103|0.4266|0.0552
70963988|NCT01807923|141433274|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6438||||0.0512|TWO_SIDED|95.0|0.4142|1.0005|||Cochran-Mantel-Haenszel|||Analysis was performed as described in Statistical Analysis 1.||1.0005|0.4142|0.0512
70963989|NCT01807923|141433275|SUPERIORITY_OR_OTHER||LS Mean Difference|0.006||||0.5604|TWO_SIDED|95.0|-0.0142|0.0262|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline EQ-5D-3L index score.||0.0262|-0.0142|0.5604
70963990|NCT01807923|141433275|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0095||||0.3613|TWO_SIDED|95.0|-0.0109|0.0298|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||0.0298|-0.0109|0.3613
70963991|NCT01807923|141433276|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1||||0.1342|TWO_SIDED|95.0|-0.7|4.9|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline EQ-5D-3L VAS score.||4.9|-0.7|0.1342
70963992|NCT01807923|141433276|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4||||0.3071|TWO_SIDED|95.0|-1.3|4.2|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||4.2|-1.3|0.3071
70963993|NCT01807923|141433277|SUPERIORITY_OR_OTHER||LS Mean Difference|5.49||||0.016|TWO_SIDED|95.0|1.03|9.96|||MMRM|||Effectiveness: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM effectiveness score.||9.96|1.03|0.0160
70963994|NCT01807923|141433277|SUPERIORITY_OR_OTHER||LS Mean Difference|5.8||||0.0126|TWO_SIDED|95.0|1.25|10.35|||MMRM|||Effectiveness: analysis was performed as described in Statistical Analysis 1.||10.35|1.25|0.0126
70963995|NCT01807923|141433277|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.18||||0.0074|TWO_SIDED|95.0|-7.23|-1.13|||MMRM|||Side Effects: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM side effects score.||-1.13|-7.23|0.0074
70963996|NCT01807923|141433277|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.74||||0.0029|TWO_SIDED|95.0|-7.85|-1.63|||MMRM|||Side Effects: analysis was performed as described in Statistical Analysis 1.||-1.63|-7.85|0.0029
70963997|NCT01807923|141433277|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61||||0.7721|TWO_SIDED|95.0|-3.5|4.71|||MMRM|||Convenience: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM convenience score.||4.71|-3.50|0.7721
70963998|NCT01807923|141433277|SUPERIORITY_OR_OTHER||LS Mean Difference|3.08||||0.1472|TWO_SIDED|95.0|-1.09|7.25|||MMRM|||Convenience: analysis was performed as described in Statistical Analysis 1.||7.25|-1.09|0.1472
70963999|NCT01807923|141433277|SUPERIORITY_OR_OTHER||LS Mean Difference|5.49||||0.0345|TWO_SIDED|95.0|0.4|10.58|||MMRM|||Global Satisfaction: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM global satisfaction score.||10.58|0.40|0.0345
70964000|NCT01807923|141433277|SUPERIORITY_OR_OTHER||LS Mean Difference|6.72||||0.0109|TWO_SIDED|95.0|1.55|11.89|||MMRM|||Global Satisfaction: analysis was performed as described in Statistical Analysis 1.||11.89|1.55|0.0109
70964001|NCT01910116|141433286|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Assuming that an improvement in AUSCAN pain score of \>10 is clinically meaningful, and assuming an alpha level of 0.05 (two-tailed), a power of 0.80, and a dropout rate of 20%, the sample size calculation revealed that 220 patients should be enrolled.||||0.014
70964002|NCT01910116|141433287|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.011
70964003|NCT01910116|141433288|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.053
70964004|NCT01910116|141433289|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.014
70964005|NCT01910116|141433290|SUPERIORITY_OR_OTHER|||||||0.728|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.728
70964006|NCT01910116|141433291|SUPERIORITY_OR_OTHER|||||||0.229|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.229
70964007|NCT01910116|141433292|SUPERIORITY_OR_OTHER|||||||0.194|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.194
70964008|NCT01910116|141433293|SUPERIORITY_OR_OTHER|||||||0.347|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.347
70964009|NCT01910116|141433294|SUPERIORITY_OR_OTHER|||||||0.122|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.122
70964010|NCT01910116|141433295|SUPERIORITY_OR_OTHER|||||||0.097|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.097
70964011|NCT01910116|141433297|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.050
70964012|NCT01910116|141433298|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.031
70964013|NCT01910116|141433299|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.021
70964014|NCT01910116|141433300|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.049
70964015|NCT01910116|141433301|SUPERIORITY_OR_OTHER|||||||0.221|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.221
70964016|NCT01910116|141433302|SUPERIORITY_OR_OTHER|||||||0.174|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.174
70964017|NCT01910116|141433303|SUPERIORITY_OR_OTHER|||||||0.124|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.124
70964018|NCT01910116|141433304|SUPERIORITY_OR_OTHER|||||||0.128|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.128
70964019|NCT01910116|141433305|SUPERIORITY_OR_OTHER|||||||0.126|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.126
70964020|NCT01910116|141433306|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.042
70964021|NCT01910116|141433307|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.660
70964022|NCT01910116|141433308|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.006
70964023|NCT01910116|141433309|SUPERIORITY_OR_OTHER|||||||0.186|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.186
70964024|NCT01910116|141433310|SUPERIORITY_OR_OTHER|||||||0.493|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.493
70964025|NCT01910116|141433311|SUPERIORITY_OR_OTHER|||||||0.062|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.062
70964026|NCT01910116|141433312|SUPERIORITY_OR_OTHER|||||||0.604|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.604
70964027|NCT01910116|141433313|SUPERIORITY_OR_OTHER|||||||0.252|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.252
70964028|NCT01910116|141433314|SUPERIORITY_OR_OTHER|||||||0.378|TWO_SIDED||||||Chi-squared|||||||0.378
70964029|NCT01910116|141433315|SUPERIORITY_OR_OTHER|||||||0.485|TWO_SIDED||||||Chi-squared|||||||0.485
70964030|NCT01910116|141433316|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.000
70964031|NCT01910116|141433317|SUPERIORITY_OR_OTHER|||||||0.683|TWO_SIDED||||||Fisher Exact|||||||0.683
70964032|NCT01910116|141433318|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED||||||Chi-squared|||||||0.036
70964033|NCT01910116|141433319|SUPERIORITY_OR_OTHER|||||||0.022|TWO_SIDED||||||Chi-squared|||||||0.022
70964034|NCT01910116|141433320|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED||||||Chi-squared|||||||0.017
70964035|NCT01910116|141433321|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Chi-squared|||||||0.060
70964036|NCT03606980|141433322|EQUIVALENCE|p\<0.05 was considered statistically significant. A 95% confidence interval was computed using logistic regression model.|Hazard Ratio (HR)|3.11||||0.0366|TWO_SIDED|95.0|1.073|9.005|||Cox proportional hazards analysis|||||9.005|1.073|0.0366
70964037|NCT03606980|141433322|EQUIVALENCE|p\<0.05 was considered statistically significant.|Hazard Ratio (HR)|4.16||||0.0232|TWO_SIDED|95.0|1.215|14.273|||Cox proportional hazards analysis|||||14.273|1.215|0.0232
70964038|NCT03606980|141433322|EQUIVALENCE|p\<0.05 was considered statistically significant.|Hazard Ratio (HR)|1.24||||0.64|TWO_SIDED|95.0|0.389|4.615|||Cox proportional hazards analysis|||||4.615|0.389|0.64
70964039|NCT03606980|141433323|EQUIVALENCE|All statistical tests were two-sided, and p\<0.05 was considered statistically significant.||||||0.86|||||||ANOVA|||||||0.86
70964040|NCT03606980|141433324|EQUIVALENCE|p\<00.05 was considered statistically significant.||||||0.25|||||||ANOVA|||||||0.25
70964041|NCT03606980|141433325|EQUIVALENCE|p\<0.05 considered statistically significant.||||||0.29|||||||ANOVA|||||||0.29
70964042|NCT03606980|141433326|EQUIVALENCE|All statistical tests were performed using the SAS Studio. All statistical tests were two-sided, and p\<0.05 was considered statistically significant.||||||0.57|||||||ANOVA|||||||0.57
70964043|NCT02469896|141433330|SUPERIORITY||Risk Ratio (RR)|0.875||||0.602|TWO_SIDED|95.0|0.556|1.377|||Fisher Exact|||||1.377|0.556|0.602
70964044|NCT02469896|141433331|SUPERIORITY||||||||||||||||||No statistical data was obtain because no patients died during the trial.|||
70964045|NCT02469896|141433332|SUPERIORITY||Slope|0.099||||0.922|TWO_SIDED|95.0|-1.902|2.099||Unadjusted|Mixed Models Analysis|||||2.099|-1.902|0.922
70964046|NCT02469896|141433333|SUPERIORITY||Difference of slopes|-0.008||||0.983|TWO_SIDED|95.0|-0.761|0.745|||Mixed Models Analysis|||||0.745|-0.761|0.983
70964047|NCT02469896|141433335|SUPERIORITY||Ratio of geometric means|1.15||||0.684|TWO_SIDED|95.0|0.566|2.337|||t-test, 2 sided|||PBMC IL-6 fold-change||2.337|0.566|0.684
70964048|NCT02469896|141433335|SUPERIORITY||Ratio of geometric means|1.344||||0.663|TWO_SIDED|95.0|0.331|2.08|||t-test, 2 sided|||||2.080|0.331|0.663
70964049|NCT02469896|141433335|SUPERIORITY||Ratio of geometric means|1.198||||0.5|TWO_SIDED|95.0|0.691|2.08|||t-test, 2 sided|||||2.080|0.691|0.500
70964050|NCT02469896|141433336|SUPERIORITY||Ratio of fold change|0.047|||<|0.001|TWO_SIDED|95.0|0.01|0.217|||Mixed Models Analysis|||||0.217|0.010|<0.001
70964051|NCT02469896|141433336|SUPERIORITY||Ratio of fold change|1.306||||0.247|TWO_SIDED|95.0|0.828|2.059|||Mixed Models Analysis|||||2.059|0.828|0.247
70964052|NCT02469896|141433336|SUPERIORITY||Ratio of fold change|19.591|||<|0.001|TWO_SIDED|95.0|11.143|34.446|||Mixed Models Analysis|||||34.446|11.143|<0.001
70964053|NCT02469896|141433336|SUPERIORITY||Ratio of fold change|1.264||||0.185|TWO_SIDED|95.0|0.892|1.791|||Mixed Models Analysis|||||1.791|0.892|0.185
70964054|NCT02469896|141433336|SUPERIORITY||Ratio of fold change|1.396||||0.427|TWO_SIDED|95.0|0.608|3.206|||Mixed Models Analysis|||||3.206|0.608|0.427
70964055|NCT02469896|141433336|SUPERIORITY||Ratio of fold change|0.893||||0.285|TWO_SIDED|95.0|0.725|1.1|||Mixed Models Analysis|||||1.100|0.725|0.285
70964056|NCT02469896|141433337|SUPERIORITY||Ratio of fold change|0.167||||0.011|TWO_SIDED|95.0|0.043|0.643|||Mixed Models Analysis|||||0.643|0.043|0.011
70964057|NCT02469896|141433337|SUPERIORITY||Ratio of fold change|0.741||||0.604|TWO_SIDED|95.0|0.228|2.405|||Mixed Models Analysis|||||2.405|0.228|0.604
70964058|NCT02469896|141433337|SUPERIORITY||Ratio of fold change|2.94|||<|0.001|TWO_SIDED|95.0|1.823|4.74|||Mixed Models Analysis|||||4.740|1.823|<0.001
70964059|NCT02469896|141433337|SUPERIORITY||Ratio of fold change|1.078||||0.587|TWO_SIDED|95.0|0.813|1.431|||Mixed Models Analysis|||||1.431|0.813|0.587
70903512|NCT01350141|141295513|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.647||||0.2928|TWO_SIDED|95.0|0.22|142.04|||Regression, Logistic|||Day 29: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||142.04|0.22|0.2928
70903513|NCT01350141|141295513|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|591.174||||0.0014|TWO_SIDED|95.0|11.68|29922.99|||Regression, Logistic|||Day 29: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||29922.99|11.68|0.0014
70903514|NCT01350141|141295513|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.468||||0.2339|TWO_SIDED|95.0|0.45|26.88|||Regression, Logistic|||Day 57: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||26.88|0.45|0.2339
70903515|NCT01350141|141295513|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|23.442||||0.0025|TWO_SIDED|95.0|3.03|181.11|||Regression, Logistic|||Day 57: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||181.11|3.03|0.0025
70903516|NCT01350141|141295513|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.502||||0.1786|TWO_SIDED|95.0|0.38|192.32|||Regression, Logistic|||Day 85: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||192.32|0.38|0.1786
70903517|NCT01350141|141295513|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|51.185||||0.0121|TWO_SIDED|95.0|2.37|1107.57|||Regression, Logistic|||Day 85: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||1107.57|2.37|0.0121
70903518|NCT01588990|141295525|SUPERIORITY_OR_OTHER|||||||0.101|||||||Cox Proportional Hazards Model|||||||0.101
70903519|NCT01588990|141295537|SUPERIORITY_OR_OTHER|||||||0.052|||||||Cox Proportional Hazards Model|||||||0.052
70903520|NCT01588990|141295538|SUPERIORITY_OR_OTHER|||||||0.797|||||||Cox Proportional Hazards Model|||||||0.797
70903521|NCT01588990|141295539|SUPERIORITY_OR_OTHER|||||||0.188|||||||Cox Proportional Hazards Model|||||||0.188
70903522|NCT01588990|141295540|SUPERIORITY_OR_OTHER|||||||0.016|||||||Cox Proportional Hazards Model|||||||0.016
70903523|NCT02367716|141295550|OTHER|The mean change in QRS duration between Baseline and 6 months|Mean Difference (Final Values)|-13.9|STANDARD_DEVIATION|29.6|||TWO_SIDED|||||||||||||
70903524|NCT01641926|141295578|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|1.6|||||TWO_SIDED|95.0|-8.4|11.6||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (hepatitis B Virus \[HBV\] genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.||11.6|-8.4|
70903525|NCT01641926|141295579|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|-3.0|||||TWO_SIDED|95.0|-20.2|14.3||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (HBV genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.||14.3|-20.2|
70903526|NCT01641926|141295580|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|2.6|||||TWO_SIDED|95.0|-7.2|12.3||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (HBV genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.||12.3|-7.2|
70903527|NCT01641926|141295581|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|2.1|||||TWO_SIDED|95.0|-9.5|13.6||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (HBV genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.||13.6|-9.5|
70903528|NCT01641926|141295581|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|10.1|||||TWO_SIDED|95.0|-7.2|27.1||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (HBV genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.||27.1|-7.2|
70903529|NCT01641926|141295582|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|0.9|||||TWO_SIDED|95.0|-7.4|9.2||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (HBV genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.||9.2|-7.4|
70903530|NCT02294630|141295589|OTHER|||||||0.399|||||||t-test, 2 sided|||||||0.399
70903531|NCT02567825|141295609|SUPERIORITY||Risk Ratio (RR)|0.97||||0.66|TWO_SIDED|95.0|0.84|1.12|||Generalized linear model|The p-value is adjusted for site, age at enrollment, and exposure or nonexposure to other children.|The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the rate of occurrence of AOM per child-year during the 2-year follow-up period.||1.12|0.84|0.66
70903532|NCT02567825|141295610|SUPERIORITY||Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.67|1.01|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator.|Null hypothesis: There is no difference between the two groups in the rate of occurrence of AOM per child-year during the 2 year follow-up among children considered at low risk of AOM recurrences at enrollment..||1.01|0.67|
70903533|NCT02567825|141295610|SUPERIORITY||Risk Ratio (RR)|1.07|||||TWO_SIDED|95.0|0.86|1.33|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator.|Null hypothesis: There is no difference between the two groups in the rate of occurrence of AOM per child-year during the 2 year follow-up among children considered at high risk of AOM recurrences at enrollment.||1.33|0.86|
70964060|NCT02469896|141433337|SUPERIORITY||Ratio of fold change|1.078||||0.697|TWO_SIDED|95.0|0.728|1.595|||Mixed Models Analysis|||||1.595|0.728|0.697
70964061|NCT02469896|141433338|SUPERIORITY||Ratio of fold change|1.785|||<|0.001|TWO_SIDED|95.0|1.502|2.121|||Mixed Models Analysis|||||2.121|1.502|<0.001
70964062|NCT01294150|141433341|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||Assuming unequal variances comparing mean improvement in the UL group to 125% of the mean improvement in the Control group. A p-value of 0.025 or less associated with UL is considered evidence of statistical significance|t-test, 2 sided|||||||0.003
70964063|NCT00782288|141433413|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Measures were compared between Baseline, Treatment \& Recovery periods to determine if changes from baseline differed between placebo and the two digitoxin dose levels. Kruskal-Wallis equity of population rank test was performed on the changes Day 28 minus Day 1. To compare the change from baseline to treatment period between the two arms, a Wilcoxon rank sum test was performed. To determine whether induced sputum Il-8 returned to baseline at the final visit, a one sample sign test was performed.||||>0.05
70964064|NCT00782288|141433419|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline,Treatment and Recovery periods were compared to determine if changes from baseline differed between placebo and the two digitoxin doses.||||>0.05
70964065|NCT00601250|141433428|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.78|-0.5|||ANCOVA|||Linagliptin vs. Placebo||-0.5|-0.78|<0.0001
70964066|NCT00601250|141433429|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.431|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.53|-0.333|||ANCOVA|||Linagliptin vs. Placebo||-0.333|-0.530|<0.0001
70964067|NCT00601250|141433430|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.596|STANDARD_ERROR_OF_MEAN|0.064|<|0.0001||95.0|-0.721|-0.471|||ANCOVA|||Linagliptin vs. Placebo||-0.471|-0.721|<0.0001
70964068|NCT00601250|141433431|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.648|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001||95.0|-0.785|-0.512|||ANCOVA|||Linagliptin vs. Placebo||-0.512|-0.785|<0.0001
70964069|NCT00601250|141433432|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-21.13|STANDARD_ERROR_OF_MEAN|3.14|<|0.0001||95.0|-27.3|-14.96|||ANCOVA|||Linagliptin vs. Placebo||-14.96|-27.3|<0.0001
70964070|NCT00601250|141433433|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-16.52|STANDARD_ERROR_OF_MEAN|2.67|<|0.0001||95.0|-21.76|-11.29|||ANCOVA|||Linagliptin vs. Placebo||-11.29|-21.76|<0.0001
70964071|NCT00601250|141433434|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-16.73|STANDARD_ERROR_OF_MEAN|2.91|<|0.0001||95.0|-22.44|-11.01|||ANCOVA|||Linagliptin vs. Placebo||-11.01|-22.44|<0.0001
70964072|NCT00601250|141433435|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-20.83|STANDARD_ERROR_OF_MEAN|3.05|<|0.0001||95.0|-26.81|-14.84|||ANCOVA|||Linagliptin vs. Placebo||-14.84|-26.81|<0.0001
70964073|NCT00601250|141433436|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.395|||<|0.0001||95.0|2.41|8.013|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."||8.013|2.410|<0.0001
70964074|NCT00601250|141433438|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.456||||0.0016||95.0|1.907|15.614|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."||15.614|1.907|0.0016
70964075|NCT00601250|141433440|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.754|||<|0.0001||95.0|2.486|5.669|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."||5.669|2.486|<0.0001
70964076|NCT00601250|141433441|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-67.13|STANDARD_ERROR_OF_MEAN|13.88|<|0.0001|TWO_SIDED|95.0|-94.69|-39.58|||ANCOVA|||Linagliptin vs. Placebo||-39.58|-94.69|<0.0001
70964077|NCT00601250|141433442|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-41.8|STANDARD_ERROR_OF_MEAN|10.02|<|0.0001|TWO_SIDED|95.0|-61.71|-21.89|||ANCOVA|||Linagliptin vs. Placebo||-21.89|-61.71|<0.0001
70964078|NCT01703663|141433445|SUPERIORITY_OR_OTHER||absolute difference|-5.73||||0.183|TWO_SIDED|95.0|-14.4|2.97|||ANOVA|||||2.97|-14.4|0.183
70964079|NCT00315939|141433553|SUPERIORITY_OR_OTHER||||||=|0.001|||||||ANOVA|||||||=0.001
70964080|NCT01436071|141433570|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.12||||0.012|TWO_SIDED|95.0|0.026|0.213|||ANCOVA|||||0.213|0.026|0.012
70964081|NCT00789867|141433576|OTHER|||||||0.0002|||||||Kruskal-Wallis|||||||0.0002
70964082|NCT00789867|141433577|OTHER|||||||0.22|||||||Kruskal-Wallis|||||||0.22
70964083|NCT00789867|141433578|OTHER|||||||0.06|||||||Kruskal-Wallis|||||||0.06
70964084|NCT00789867|141433579|OTHER|||||||0.08|||||||Kruskal-Wallis|||||||0.08
70964085|NCT00789867|141433580|OTHER|||||||0.22|||||||Kruskal-Wallis|||||||0.22
70964086|NCT00789867|141433581|OTHER|||||||0.003|||||||Kruskal-Wallis|||||||0.003
70964087|NCT00726622|141433584|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Assuming a baseline rate of 90% oncologic success for the open resection arm, the sample size provided 80% power to declare non-inferiority if oncologic success rates were truly identical, using a 1-sided z score with α = .10 for falsely declaring non-inferiority when the true oncologic success rate for laparoscopic resection was 84%. Calculations were based on a 2-sample binomial non-inferiority calculation with a 90% success rate for the control group and a 6% non-inferiority margin.||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
70964088|NCT02462928|141433597|NON_INFERIORITY|For hypothesis testing, if the lower limit of 95.1% Confidence Interval (CI) for the difference between an abicipar group and ranibizumab was greater than or equal to -10%, non-inferiority of abicipar was established.|Percentage Difference|-3.8|||||TWO_SIDED|95.1|-8.2|0.3|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as stratification factor.|||0.3|-8.2|
70964089|NCT02462928|141433597|NON_INFERIORITY|For hypothesis testing, if the lower limit of 95.1% Confidence Interval (CI) for the difference between an abicipar group and ranibizumab was greater than or equal to -10%, non-inferiority of abicipar was established.|Percentage Difference|-4.2|||||TWO_SIDED|95.1|-8.7|0.0|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as stratification factor.|||0.0|-8.7|
70964090|NCT02462928|141433598|NON_INFERIORITY|For hypothesis testing, non-inferiority of abicipar is established if the lower limit of the CI is \> - 5.0 letters.|Least Squares (LS) Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.2|||TWO_SIDED|95.1|-4.7|-0.1|||||MMRM included treatment, region, BL BCVA, BL CRT ≤400 or \>400, choroidal neovascularization lesion type, visit, visit-by-BL BCVA interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.|||-0.1|-4.7|
70964091|NCT02462928|141433598|NON_INFERIORITY|For hypothesis testing, non-inferiority of abicipar is established if the lower limit of the CI is \> - 5.0 letters.|LS Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|1.2|||TWO_SIDED|95.1|-6.0|-1.3|||||MMRM included treatment, region, BL BCVA, BL CRT ≤400 or \>400, choroidal neovascularization lesion type, visit, visit-by-BL BCVA interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.|||-1.3|-6.0|
70964092|NCT02462928|141433599|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|LS Mean Difference|8.6|STANDARD_ERROR_OF_MEAN|6.3|||TWO_SIDED|95.1|-3.8|20.9|||||MMRM was used for analyses with covariates (treatment, region, baseline BCVA, CRT, choroidal neovascularization lesion type, visit, visit by baseline BCVA and treatment by visit interaction) with unstructured covariance matrix.|||20.9|-3.8|
70964093|NCT02462928|141433599|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|LS Mean Difference|2.3|STANDARD_ERROR_OF_MEAN|6.3|||TWO_SIDED|95.1|-10.1|14.7|||||MMRM was used for analyses with covariates (treatment, region, baseline BCVA, CRT, choroidal neovascularization lesion type, visit, visit by baseline BCVA and treatment by visit interaction) with unstructured covariance matrix.|||14.7|-10.1|
70964094|NCT02462928|141433600|SUPERIORITY||Percentage Difference|-4.7|||||TWO_SIDED|95.1|-11.5|2.1|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as the stratification factor.|||2.1|-11.5|
70964095|NCT02462928|141433600|SUPERIORITY||Percentage Difference|-8.2|||||TWO_SIDED|95.1|-14.7|-1.5|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as the stratification factor.|||-1.5|-14.7|
70964096|NCT02462928|141433601|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.1|-3.7|0.0|||||MMRM was used for analyses with covariates (treatment, region, baseline BCVA, visual function questionnaire (VFQ) score, visit, visit by baseline BCVA and treatment by visit interaction) with unstructured covariance matrix.|||-0.0|-3.7|
70964097|NCT02462928|141433601|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.1|-2.7|1.0|||||MMRM was used for analyses with covariates (treatment, region, baseline BCVA, visual function questionnaire (VFQ) score, visit, visit by baseline BCVA and treatment by visit interaction) with unstructured covariance matrix.|||1.0|-2.7|
70964098|NCT01493557|141433602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.31||||0.2554|TWO_SIDED|95.0|-6.54|29.49|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.||29.49|-6.54|0.2554
70964099|NCT01493557|141433603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1||||0.3165|TWO_SIDED|95.0|-11.24|24.58|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.||24.58|-11.24|0.3165
70964100|NCT01493557|141433604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.41||||0.0273|TWO_SIDED|95.0|0.71|35.98|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.||35.98|0.71|0.0273
70964101|NCT01493557|141433605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.52||||0.7104|TWO_SIDED|95.0|-44.22|28.4|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.||28.40|-44.22|0.7104
70964102|NCT01493557|141433606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.81||||1|TWO_SIDED|95.0|-32.94|40.44|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.||40.44|-32.94|1.0000
70964103|NCT01493557|141433607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.71||||1|TWO_SIDED|95.0|-41.25|28.77|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.||28.77|-41.25|1.0000
70964104|NCT01493557|141433611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-9.9|8.9|||||Mean difference = (Mean number of days for Pradaxa w/meal) - (Mean number of days for pantoprazole).|Mean difference for the Duration of gastrointestinal symptoms (GIS).||8.9|-9.9|
70964105|NCT01493557|141433611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-3.5|6.3|||||Mean difference = (Mean number of days for Pradaxa w/meal) - (Mean number of days for pantoprazole).|Mean difference for Time to first complete effectiveness. Complete effectiveness of a gastrointestinal symptoms (GIS) management strategy can only be measured at a point in time. Because the same or a different GIS could occur after a time of effective GIS management, the patients who indicated some degree of effectiveness at one visit may not be the same patients who experience effectiveness at a subsequent visit.||6.3|-3.5|
70964106|NCT01493557|141433611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.2|||||TWO_SIDED|95.0|-8.2|48.5|||||Mean difference = (Mean number of days for Pradaxa w/meal) - (Mean number of days for pantoprazole).|Mean difference for Time to first complete effectiveness. Partial effectiveness of a gastrointestinal symptoms (GIS) management strategy can only be measured at a point in time. Because the same or a different GIS could occur after a time of effective GIS management, the patients who indicated some degree of effectiveness at one visit may not be the same patients who experience effectiveness at a subsequent visit.||48.5|-8.2|
70964107|NCT02656420|141433616|EQUIVALENCE|Statistical significance of the treatment effect (p \< 0.01) for the lower doses compared to the high dose as the reference.|Mean Difference (Final Values)|-1.73|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-1.89|-1.57||Using a linear mixed effects model with random intercepts and slope, SF level (in the log scale) was regressed on categorical treatment group (medium dose and low dose; high as the reference) as well as day (continuous variable).|Mixed Models Analysis|||The null hypothesis is that the urinary sulforaphane levels are equal across treatment arms. Sulforaphane metabolite levels were measured daily for 10 days in each arm.||-1.57|-1.89|<0.001
70964108|NCT02656420|141433617|SUPERIORITY|To summarize first 12-hour SPMA levels over the study course by participant, the SPMA geometric mean (in the log scale) for each individual was calculated and used as the outcome. Treatment arms (placebo, fifth, half and full doses) were independent (categorical) variables in a linear regression model with placebo as the reference.|Mean Difference (Final Values)|63.2|||<|0.05|TWO_SIDED|95.0|10.6|140.9|||Regression, Linear||This Estimation Parameter was based on the comparison between the full dose group and the placebo group.|All broccoli sprout arms were compared with the placebo arm.||140.9|10.6|<0.05
70964109|NCT03662139|141433635|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Between group difference||||<0.01
70964110|NCT03662139|141433635|SUPERIORITY||ICC|0.97|||<|0.05|TWO_SIDED|95.0|0.915|0.99|||Intraclass Correlation Coefficient(ICC)|Two-way random-effect model|Reliability estimates were interpreted as follows: \>0.90=excellent; 0.75-0.90=good; 0.50-0.75=medium; \<0.50=low|Test - Retest Reliability (Difference between 1st and 2nd assessments in Cerebral Palsy group)||0.99|0.915|<0.05
70964111|NCT03662139|141433635|SUPERIORITY||ICC|0.983|||<|0.01|TWO_SIDED|95.0|0.882|0.998|||Intraclass Correlation Coefficient(ICC)|Two-way random-effect model|Reliability estimates were interpreted as follows: \>0.90=excellent; 0.75-0.90=good; 0.50-0.75=medium; \<0.50=low|Interrater Reliability (Difference between 1st and 2nd evaluators in Cerebral Palsy group)||0.998|0.882|<0.01
70964112|NCT03662139|141433636|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Between group difference||||<0.01
70964113|NCT03662139|141433636|SUPERIORITY||Spearman's correlation coefficient (rs)|0.724|||<|0.05|TWO_SIDED||||||Spearman's Correlation Test|The level of relationship was classified as follows \<0.30=small/negligible; 0.30-0.50=low; 0.50-0.70=moderate; 0.70-0.90=high; \>0.90=very high.||Correlation between Dynamic Gait Index (DGI) and Pediatric Balance Scale (PBS) scores in Cerebral Palsy group||||<0.05
70964114|NCT03662139|141433637|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Between group difference||||<0.01
70964115|NCT03662139|141433637|SUPERIORITY||Spearman's correlation coefficient (rs)|-0.828|||<|0.01|TWO_SIDED||||||Spearman's Correlation Test||The level of relationship was classified as follows \<0.30=small/negligible; 0.30-0.50=low; 0.50-0.70=moderate; 0.70-0.90=high; \>0.90=very high.|Correlation between Dynamic Gait Index (DGI) and Timed Up and Go Test (TUG) scores in Cerebral Palsy group||||<0.01
70964116|NCT03662139|141433638|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Between group difference||||<0.01
70964117|NCT03662139|141433638|SUPERIORITY||Spearman's correlation coefficient (rs)|-0.673|||<|0.05|TWO_SIDED||||||Spearman's Correlation Test||The level of relationship was classified as follows \<0.30=small/negligible; 0.30-0.50=low; 0.50-0.70=moderate; 0.70-0.90=high; \>0.90=very high.|Correlation between Dynamic Gait Index (DGI) and Four Square Step Test (FSST) scores in Cerebral Palsy group.||||<0.05
70964118|NCT01215175|141433657|OTHER||Risk Difference (RD)|10.0||||||95.0|-7.4|28.3|||||Miettinen \& Nurminen method|||28.3|-7.4|
70964119|NCT01215175|141433658|OTHER||Risk Difference (RD)|8.2||||||95.0|-7.9|26.6|||||Miettinen \& Nurminen method|||26.6|-7.9|
70964120|NCT01215175|141433658|OTHER||Risk Difference (RD)|3.6||||||95.0|-15.5|22.9|||||Miettinen \& Nurminen method|||22.9|-15.5|
70964121|NCT01215175|141433659|OTHER||Risk Difference (RD)|0.0||||||95.0|-11.5|11.5|||||Miettinen \& Nurminen method|||11.5|-11.5|
70964122|NCT01215175|141433660|OTHER||Risk Difference (RD)|0.0||||||95.0|-12.2|10.6|||||Miettinen \& Nurminen method|||10.6|-12.2|
70964123|NCT01215175|141433660|OTHER||Risk Difference (RD)|0.0||||||95.0|-12.3|12.3|||||Miettinen \& Nurminen method|||12.3|-12.3|
70964124|NCT01215175|141433661|OTHER||Risk Difference (RD)|10.0||||||95.0|-7.4|28.3|||||Miettinen \& Nurminen method|||28.3|-7.4|
70964125|NCT01215175|141433662|OTHER||Risk Difference (RD)|9.8||||||95.0|-10.6|30.9|||||Miettinen \& Nurminen method|||30.9|-10.6|
70964126|NCT01215175|141433662|OTHER||Risk Difference (RD)|3.6||||||95.0|-19.1|26.0|||||Miettinen \& Nurminen method|||26.0|-19.1|
70964127|NCT00702845|141433678|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence margins of -3 and +5 were applied for the difference in the mean number of oocytes between the treatment groups. Org 36286 treatment was considered equivalent to the reference treatment (recFSH) if the two-sided 95% confidence interval of the difference was between -3 and +5 oocytes.|Mean Difference (Final Values)|2.5|||<|0.001|TWO_SIDED|95.0|1.2|3.9|||ANOVA|||||3.9|1.2|<0.001
70964128|NCT02973425|141433700|OTHER||Cox Proportional Hazard|1.68||||0.02|TWO_SIDED|95.0|1.09|2.6|||Regression, Cox|||The primary hypothesis was tested through a time-to-event analysis implemented using Cox proportional hazards models||2.60|1.09|0.02
70964129|NCT02973425|141433701|OTHER||Linear regression|0.03||||0.03|TWO_SIDED|95.0|||||Regression, Linear|||For hypothesis 3, we compared the mean score on the SEQ-12 and its subscales at 6 months, adjusting for baseline.||||0.03
70964130|NCT02973425|141433702|OTHER|Six-month OR, 95%CI, and P value were calculated from generalized estimating equation marginal models with a logit link and an exchangeable correlation matrix.|Odds Ratio (OR)|1.92||||0.048|TWO_SIDED|95.0|1.01|3.68||Analysis models were adjusted by study site, having quit attempts in the past 12 months measured at baseline, cigarettes per day measured at baseline, quit attempts in the past 12 months measured at baseline.|Chi-squared|||||3.68|1.01|0.048
70964131|NCT02973425|141433703|OTHER||Odds Ratio (OR)|2.01||||0.01|TWO_SIDED|95.0|||||Regression, Linear|||During the first 3 weeks from randomization, both the Take a Break and comparison groups reported the number of cigarettes smoked daily (by texting); texting response rate (responded on at least 1 day).||||0.01
70964132|NCT03503513|141433718|SUPERIORITY||Risk Ratio (RR)|0.17|||<|0.0001|TWO_SIDED|95.0|0.03|0.2|||differences in incidence rate ratio|An incidence rate ratio per person/month was determined by comparing the total number of UTIs in relation to time points.||comparison between pre and during treatment rates of UTI||0.20|0.03|<0.0001
70964133|NCT03503513|141433719|SUPERIORITY||Mean Difference (Final Values)|-3.8|STANDARD_DEVIATION|6.13|<|0.06|TWO_SIDED|95.0|-7.9|0.3||a priori threshold p value of \<0.05|t-test, 2 sided||Baseline to end of 6 month treatment score comparisons; (higher numbers represent more symptoms or complications)|NBSS Domain score for incontinence pre-post comparison; small sample size did not allow for power calculation.||0.3|-7.9|<0.06
70964134|NCT03503513|141433719|SUPERIORITY||Mean Difference (Final Values)|-1.1|STANDARD_DEVIATION|4.09|<|0.39|TWO_SIDED|95.0|-3.8|1.7||a priori threshold p\<0.05|t-test, 2 sided||(higher numbers represent more symptoms or complications)|NBSS Domain score for storage and voiding; pre-post comparison. Due to small sample size (n=11) no power calculations were conducted.||1.7|-3.8|<0.39
70964135|NCT03503513|141433719|SUPERIORITY||Mean Difference (Final Values)|-1.9|STANDARD_DEVIATION|3.99|<|0.14|TWO_SIDED|95.0|-4.6|0.8|||t-test, 2 sided||Higher numbers represent more symptoms or complications referred as consequences.|Pre and post test comparisons of mean NBSS scores for the consequences domain. Power calculations were not conducted due to small sample size.||0.8|-4.6|<0.14
70964136|NCT03503513|141433720|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_DEVIATION|6.99|<|0.34|TWO_SIDED|95.0|-6.8|2.6|||t-test, 2 sided|||||2.6|-6.8|<0.34
70964137|NCT03627767|141433756|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.0001|TWO_SIDED|95.0|0.286|0.424||A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.|Log Rank|||A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.||0.424|0.286|< 0.0001
70964138|NCT03627767|141433756|SUPERIORITY||Hazard Ratio (HR)|0.22|||<|0.0001|TWO_SIDED|95.0|0.176|0.27||A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.|Log Rank|||A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.||0.270|0.176|< 0.0001
70964139|NCT03627767|141433756|SUPERIORITY||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.503|0.78||A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.|Log Rank|||A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.||0.780|0.503|< 0.0001
70964140|NCT03627767|141433757|SUPERIORITY||Difference in percentage|0.0|||=|0.9495|TWO_SIDED|95.0|-1.0|1.1||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||1.1|-1.0|= 0.9495
70964141|NCT03627767|141433757|SUPERIORITY||Difference in percentage|-0.4|||=|0.5717|TWO_SIDED|95.0|-1.6|0.9||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||0.9|-1.6|= 0.5717
70964142|NCT03627767|141433757|SUPERIORITY||Difference in percentage|-0.4|||||TWO_SIDED|95.0|-1.7|0.9||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||0.9|-1.7|
70964143|NCT03627767|141433757|SUPERIORITY||Difference in percentage|40.5|||<|0.0001|TWO_SIDED|95.0|33.1|47.8||P-value was adjusted by disease severity at baseline and randomization strata|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||47.8|33.1|< 0.0001
70964144|NCT03627767|141433757|SUPERIORITY||Difference in percentage|62.6|||<|0.0001|TWO_SIDED|95.0|56.1|69.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||69.2|56.1|< 0.0001
70964145|NCT03627767|141433757|SUPERIORITY||Difference in percentage|22.1|||||TWO_SIDED|95.0|14.3|29.9||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||29.9|14.3|
70964146|NCT03627767|141433757|SUPERIORITY||Difference in percentage|35.1|||<|0.0001|TWO_SIDED|95.0|28.1|42.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||42.0|28.1|< 0.0001
70964147|NCT03627767|141433757|SUPERIORITY||Difference in percentage|51.5|||<|0.0001|TWO_SIDED|95.0|44.6|58.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||58.4|44.6|< 0.0001
70964148|NCT03627767|141433757|SUPERIORITY||Difference in percentage|16.5|||||TWO_SIDED|95.0|8.1|24.8||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||24.8|8.1|
70964149|NCT03627767|141433757|SUPERIORITY||Difference in percentage|32.2|||<|0.0001|TWO_SIDED|95.0|25.2|39.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||39.2|25.2|< 0.0001
70964150|NCT03627767|141433757|SUPERIORITY||Difference in percentage|46.9|||<|0.0001|TWO_SIDED|95.0|39.9|53.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||53.8|39.9|< 0.0001
70964151|NCT03627767|141433757|SUPERIORITY||Difference in percentage|14.2|||||TWO_SIDED|95.0|5.9|22.6||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||22.6|5.9|
70964152|NCT03627767|141433757|SUPERIORITY||Difference in percentage|25.5|||<|0.0001|TWO_SIDED|95.0|18.5|32.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||32.5|18.5|< 0.0001
70964153|NCT03627767|141433757|SUPERIORITY||Difference in percentage|42.5|||<|0.0001|TWO_SIDED|95.0|35.3|49.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||49.7|35.3|< 0.0001
70964154|NCT03627767|141433757|SUPERIORITY||Difference in percentage|17.1|||||TWO_SIDED|95.0|8.6|25.5||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.5|8.6|
70964155|NCT03627767|141433758|SUPERIORITY||Difference in percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||0.0|0.0|
70964156|NCT03627767|141433758|SUPERIORITY||Difference in percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions. P-value was adjusted by disease severity at baseline and randomization strata.||0.0|0.0|
70964157|NCT03627767|141433758|SUPERIORITY||Difference in percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||0.0|0.0|
70964158|NCT03627767|141433758|SUPERIORITY||Difference in percentage|42.7|||<|0.0001|TWO_SIDED|95.0|35.3|50.1||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||50.1|35.3|< 0.0001
70964159|NCT03627767|141433758|SUPERIORITY||Difference in percentage|55.4|||<|0.0001|TWO_SIDED|95.0|49.1|61.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||61.7|49.1|< 0.0001
70964160|NCT03627767|141433758|SUPERIORITY||Difference in percentage|12.9|||||TWO_SIDED|95.0|7.9|17.9||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||17.9|7.9|
70964161|NCT03627767|141433758|SUPERIORITY||Difference in percentage|45.5|||<|0.0001|TWO_SIDED|95.0|37.9|53.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||53.0|37.9|< 0.0001
70964162|NCT03627767|141433758|SUPERIORITY||Difference in percentage|63.0|||<|0.0001|TWO_SIDED|95.0|56.4|69.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||69.5|56.4|< 0.0001
70964163|NCT03627767|141433758|SUPERIORITY||Difference in percentage|17.7|||||TWO_SIDED|95.0|10.7|24.7||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions||24.7|10.7|
70964164|NCT03627767|141433758|SUPERIORITY||Difference in percentage|41.0|||<|0.0001|TWO_SIDED|95.0|33.6|48.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||48.5|33.6|< 0.0001
70964165|NCT03627767|141433758|SUPERIORITY||Difference in percentage|58.3|||<|0.0001|TWO_SIDED|95.0|51.3|65.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||65.2|51.3|< 0.0001
70964166|NCT03627767|141433758|SUPERIORITY||Difference in percentage|17.5|||||TWO_SIDED|95.0|9.6|25.5||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.5|9.6|
70964167|NCT03627767|141433758|SUPERIORITY||Difference in percentage|35.3|||<|0.0001|TWO_SIDED|95.0|27.8|42.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||42.8|27.8|< 0.0001
70964168|NCT03627767|141433758|OTHER||Difference in percentage|55.3|||<|0.0001|TWO_SIDED|95.0|48.3|62.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||62.4|48.3|< 0.0001
70964169|NCT03627767|141433758|SUPERIORITY||Difference in percentage|20.3|||||TWO_SIDED|95.0|12.1|28.5||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||28.5|12.1|
70964170|NCT03627767|141433759|SUPERIORITY||Difference in percentage|0.7|||=|0.1848|TWO_SIDED|95.0|-0.3|1.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||1.7|-0.3|= 0.1848
70964171|NCT03627767|141433759|SUPERIORITY||Difference in percentage|0.3|||=|0.5971|TWO_SIDED|95.0|-0.9|1.6||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||1.6|-0.9|= 0.5971
70964172|NCT03627767|141433759|SUPERIORITY||Difference in percentage|-0.4|||||TWO_SIDED|95.0|-1.1|0.4||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||0.4|-1.1|
70964173|NCT03627767|141433759|SUPERIORITY||Difference in percentage|49.4|||<|0.0001|TWO_SIDED|95.0|42.0|56.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||56.8|42.0|< 0.0001
70964174|NCT03627767|141433759|SUPERIORITY||Difference in percentage|65.5|||<|0.0001|TWO_SIDED|95.0|59.3|71.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||71.7|59.3|< 0.0001
70964175|NCT03627767|141433759|SUPERIORITY||Difference in percentage|16.3|||||TWO_SIDED|95.0|10.3|22.3||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||22.3|10.3|
70964176|NCT03627767|141433759|SUPERIORITY||Difference in percentage|42.7|||<|0.0001|TWO_SIDED|95.0|35.2|50.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||50.2|35.2|< 0.0001
70964177|NCT03627767|141433759|SUPERIORITY||Difference in percentage|62.6|||<|0.0001|TWO_SIDED|95.0|56.0|69.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||69.2|56.0|< 0.0001
70964178|NCT03627767|141433759|SUPERIORITY||Difference in percentage|19.8|||||TWO_SIDED|95.0|12.3|27.4||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||27.4|12.3|
70964179|NCT03627767|141433759|SUPERIORITY||Difference in percentage|39.5|||<|0.0001|TWO_SIDED|95.0|32.1|46.9||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||46.9|32.1|< 0.0001
70964180|NCT03627767|141433759|SUPERIORITY||Difference in percentage|56.7|||<|0.0001|TWO_SIDED|95.0|49.8|63.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||63.7|49.8|< 0.0001
70964181|NCT03627767|141433759|SUPERIORITY||Difference in percentage|17.4|||||TWO_SIDED|95.0|9.3|25.5||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.5|9.3|
70903534|NCT02567825|141295610|OTHER|||||||0.08|||||||Generalized linear models|||Null hypothesis: There is no interaction between comparison group (Surgical Management, Non-Surgical Management) and risk group (children considered at low risk of AOM recurrences at enrollment, children considered at high risk of AOM recurrences at enrollment).||||0.08
70903535|NCT02567825|141295611|SUPERIORITY|||||||0.48|||||||Chi-squared|||"Null hypothesis: There is no difference between the two groups in the proportion of children completing the study with 0, 1 or 2, 3 or 4, greater than or equal to 5 episodes of AOM.~."||||0.48
70964182|NCT03627767|141433759|SUPERIORITY||Difference in percentage|33.0|||<|0.0001|TWO_SIDED|95.0|25.7|40.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||40.4|25.7|< 0.0001
70964183|NCT03627767|141433759|SUPERIORITY||Difference in percentage|51.7|||<|0.0001|TWO_SIDED|95.0|44.6|58.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||58.8|44.6|< 0.0001
70964184|NCT03627767|141433759|SUPERIORITY||Difference in percentage|19.2|||||TWO_SIDED|95.0|10.8|27.6||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||27.6|10.8|
70964185|NCT03627767|141433760|SUPERIORITY||Difference in percentage|2.6|||=|0.3994|TWO_SIDED|95.0|-3.3|8.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||8.4|-3.3|= 0.3994
70964186|NCT03627767|141433760|SUPERIORITY||Difference in percentage|1.8|||=|0.5542|TWO_SIDED|95.0|-4.1|7.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||7.8|-4.1|= 0.5542
70964187|NCT03627767|141433760|SUPERIORITY||Difference in percentage|-0.8|||||TWO_SIDED|95.0|-6.5|5.0||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||5.0|-6.5|
70964188|NCT03627767|141433760|SUPERIORITY||Difference in percentage|37.5|||<|0.0001|TWO_SIDED|95.0|30.2|44.9||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||44.9|30.2|< 0.0001
70964189|NCT03627767|141433760|SUPERIORITY||Difference in percentage|63.3|||<|0.0001|TWO_SIDED|95.0|56.8|69.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||69.8|56.8|< 0.0001
70964190|NCT03627767|141433760|SUPERIORITY||Difference in percentage|25.5|||||TWO_SIDED|95.0|17.7|33.4||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||33.4|17.7|
70964191|NCT03627767|141433760|SUPERIORITY||Difference in percentage|36.9|||<|0.0001|TWO_SIDED|95.0|29.9|44.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||44.0|29.9|< 0.0001
70964192|NCT03627767|141433760|SUPERIORITY||Difference in percentage|54.2|||<|0.0001|TWO_SIDED|95.0|47.3|61.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||61.0|47.3|< 0.0001
70964193|NCT03627767|141433760|SUPERIORITY||Difference in percentage|17.2|||||TWO_SIDED|95.0|8.9|25.5||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.5|8.9|
70964194|NCT03627767|141433760|SUPERIORITY||Difference in percentage|29.8|||<|0.0001|TWO_SIDED|95.0|22.7|37.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||37.0|22.7|< 0.0001
70964195|NCT03627767|141433760|SUPERIORITY||Difference in percentage|46.7|||<|0.0001|TWO_SIDED|95.0|39.6|53.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||53.8|39.6|< 0.0001
70964196|NCT03627767|141433760|SUPERIORITY||Difference in percentage|16.9|||||TWO_SIDED|95.0|8.5|25.3||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.3|8.5|
70964197|NCT03627767|141433760|SUPERIORITY||Difference in percentage|27.4|||<|0.0001|TWO_SIDED|95.0|20.4|34.3||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||34.3|20.4|< 0.0001
70964198|NCT03627767|141433760|SUPERIORITY||Difference in percentage|43.8|||<|0.0001|TWO_SIDED|95.0|36.7|50.9||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||50.9|36.7|< 0.0001
70964199|NCT03627767|141433760|SUPERIORITY||Difference in percentage|16.8|||||TWO_SIDED|95.0|8.4|25.2||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.2|8.4|
70964200|NCT03627767|141433761|SUPERIORITY||Difference in percentage|0.3|||=|0.9313|TWO_SIDED|95.0|-7.5|8.1||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||8.1|-7.5|= 0.9313
70964201|NCT03627767|141433761|SUPERIORITY||Difference in percentage|-2.1|||=|0.6043|TWO_SIDED|95.0|-9.8|5.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||5.7|-9.8|= 0.6043
70964202|NCT03627767|141433761|SUPERIORITY||Difference in percentage|-2.3|||||TWO_SIDED|95.0|-10.0|5.4||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||5.4|-10.0|
70964203|NCT03627767|141433761|SUPERIORITY||Difference in percentage|11.6|||<|0.0001|TWO_SIDED|95.0|6.6|16.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||16.5|6.6|< 0.0001
70964204|NCT03627767|141433761|SUPERIORITY||Difference in percentage|25.3|||<|0.0001|TWO_SIDED|95.0|19.4|31.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||31.2|19.4|< 0.0001
70964205|NCT03627767|141433761|SUPERIORITY||Difference in percentage|13.5|||||TWO_SIDED|95.0|6.6|20.4||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||20.4|6.6|
70964206|NCT03627767|141433761|SUPERIORITY||Difference in percentage|12.9|||<|0.0001|TWO_SIDED|95.0|7.7|18.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||18.0|7.7|< 0.0001
70964207|NCT03627767|141433761|SUPERIORITY||Difference in percentage|26.0|||<|0.0001|TWO_SIDED|95.0|19.9|32.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||32.0|19.9|< 0.0001
70964208|NCT03627767|141433761|SUPERIORITY||Difference in percentage|13.4|||||TWO_SIDED|95.0|6.3|20.6||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||20.6|6.3|
70964209|NCT03627767|141433761|SUPERIORITY||Difference in percentage|11.7|||<|0.0001|TWO_SIDED|95.0|6.5|16.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||16.8|6.5|< 0.0001
70964210|NCT03627767|141433761|SUPERIORITY||Difference in percentage|25.7|||<|0.0001|TWO_SIDED|95.0|19.6|31.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||31.8|19.6|< 0.0001
70964211|NCT03627767|141433761|SUPERIORITY||Difference in percentage|14.1|||||TWO_SIDED|95.0|7.0|21.2||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||21.2|7.0|
70964212|NCT03627767|141433761|SUPERIORITY||Difference in percentage|14.6|||<|0.0001|TWO_SIDED|95.0|9.2|20.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||20.0|9.2|< 0.0001
70964213|NCT03627767|141433761|SUPERIORITY||Difference in percentage|24.5|||<|0.0001|TWO_SIDED|95.0|18.4|30.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||30.5|18.4|< 0.0001
70964214|NCT03627767|141433761|SUPERIORITY||Difference in percentage|10.0|||||TWO_SIDED|95.0|2.7|17.2||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||17.2|2.7|
70964215|NCT03627767|141433762|SUPERIORITY||Difference in percentage|1.8|||=|0.6082|TWO_SIDED|95.0|-5.0|8.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||8.5|-5.0|= 0.6082
70964216|NCT03627767|141433762|SUPERIORITY||Difference in percentage|0.2|||=|0.964|TWO_SIDED|95.0|-6.7|7.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||7.0|-6.7|= 0.9640
70964217|NCT03627767|141433762|SUPERIORITY||Difference in percentage|-2.4|||||TWO_SIDED|95.0|-9.1|4.4||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||4.4|-9.1|
70964218|NCT03627767|141433762|SUPERIORITY||Difference in percentage|38.9|||<|0.0001|TWO_SIDED|95.0|31.2|46.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||46.5|31.2|< 0.0001
70964219|NCT03627767|141433762|SUPERIORITY||Difference in percentage|59.7|||<|0.0001|TWO_SIDED|95.0|52.7|66.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||66.7|52.7|< 0.0001
70964220|NCT03627767|141433762|SUPERIORITY||Difference in percentage|20.9|||||TWO_SIDED|95.0|12.7|29.0||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||29.0|12.7|
70964221|NCT03627767|141433762|SUPERIORITY||Difference in percentage|33.9|||<|0.0001|TWO_SIDED|95.0|26.6|41.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||41.2|26.6|< 0.0001
70964222|NCT03627767|141433762|SUPERIORITY||Difference in percentage|55.3|||<|0.0001|TWO_SIDED|95.0|48.2|62.3||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||62.3|48.2|< 0.0001
70964223|NCT03627767|141433762|SUPERIORITY||Difference in percentage|21.7|||||TWO_SIDED|95.0|13.2|30.2||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||30.2|13.2|
70964224|NCT03627767|141433762|SUPERIORITY||Difference in percentage|29.7|||<|0.0001|TWO_SIDED|95.0|22.7|36.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||36.7|22.7|< 0.0001
70903536|NCT02567825|141295612|SUPERIORITY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.58|0.92|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of children experiencing treatment failure.||0.92|0.58|
70964225|NCT03627767|141433762|SUPERIORITY||Difference in percentage|45.5|||<|0.0001|TWO_SIDED|95.0|38.4|52.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||52.7|38.4|< 0.0001
70964226|NCT03627767|141433762|SUPERIORITY||Difference in percentage|16.0|||||TWO_SIDED|95.0|7.4|24.6||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||24.6|7.4|
70964227|NCT03627767|141433762|SUPERIORITY||Difference in percentage|19.9|||<|0.0001|TWO_SIDED|95.0|13.0|26.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||26.8|13.0|< 0.0001
70964228|NCT03627767|141433762|SUPERIORITY||Difference in percentage|40.5|||<|0.0001|TWO_SIDED|95.0|32.8|48.1||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||48.1|32.8|< 0.0001
70964229|NCT03627767|141433762|SUPERIORITY||Difference in percentage|20.9|||||TWO_SIDED|95.0|11.8|30.0||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||30.0|11.8|
70903537|NCT02567825|141295613|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.52|0.9|||||The Surgical Management group represents the numerator for the hazard ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups regarding the time to the first episode of AOM.||0.90|0.52|
70903538|NCT02567825|141295614|SUPERIORITY||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.76|1.09|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of episodes categorized as probably severe.||1.09|0.76|
70903539|NCT02567825|141295615|SUPERIORITY||Risk Ratio (RR)|0.34|||||TWO_SIDED|95.0|0.26|0.44||||||Null hypothesis: There is no difference between the two groups in the proportion of episodes presenting with tympanic membrane bulging rather than otorrhea|The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|0.44|0.26|
70903540|NCT02567825|141295616|SUPERIORITY||Difference of least-squares means|5.21|||||TWO_SIDED|95.0|2.6|7.82|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean days per year children experience tube otorrhea. The analysis uses a weighted regression model with weights equal to the length of follow-up.||7.82|2.60|
70903541|NCT02567825|141295617|SUPERIORITY||Difference of least-squares means|-6.32|||||TWO_SIDED|95.0|-7.55|-5.1|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean days per year children experience AOM symptoms with an intact TM. The analysis uses a weighted regression model with weights equal to the length of follow-up.||-5.10|-7.55|
70903542|NCT02567825|141295618|SUPERIORITY||Difference of least-squares means|-4.5|||||TWO_SIDED|95.0|-6.82|-2.18|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean days per year children receive systemic antimicrobials for AOM. The analysis uses a weighted regression model with weights equal to the length of follow-up.||-2.18|-6.82|
70903543|NCT02567825|141295619|SUPERIORITY||Risk Ratio (RR)|0.67|||||TWO_SIDED|95.0|0.44|1.03|||||The Surgical Management group represents the numerator for the hazard ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups regarding the proportion of children for whom PDD was reported.||1.03|0.44|
70903544|NCT02567825|141295620|SUPERIORITY||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.51|1.22|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups regarding the proportion of children for whom diaper dermatitis was reported.||1.22|0.51|
70903545|NCT02567825|141295621|SUPERIORITY||Risk Ratio (RR)|2.57|||||TWO_SIDED|95.0|1.91|3.48|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups regarding the proportion of children for whom tube otorrhea was reported.||3.48|1.91|
70903546|NCT02567825|141295622|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.74|1.24|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of children with no pathogens at enrollment having a penicillin-nonsusceptible nasopharyngeal or throat isolate at some follow-up visit.||1.24|0.74|
70903547|NCT02567825|141295622|SUPERIORITY||Risk Ratio (RR)|1.2|||||TWO_SIDED|95.0|0.83|1.72|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of children positive only for at least 1 penicillin-susceptible pathogen at enrollment having a penicillin-nonsusceptible nasopharyngeal or throat isolate at some follow-up visit.||1.72|0.83|
70903548|NCT02567825|141295622|SUPERIORITY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.94|1.29|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of children positive for at least 1 penicillin nonsusceptible pathogen at enrollment having a penicillin-nonsusceptible nasopharyngeal or throat isolate at some follow-up visit.||1.29|0.94|
70903549|NCT02567825|141295623|SUPERIORITY||Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.84|1.55|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of episodes of AOM at which a nonsusceptible pathogen is recovered.||1.55|0.84|
70903550|NCT02567825|141295624|SUPERIORITY||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.84|1.41|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of routine non-illness visits at which a nonsusceptible pathogen is recovered.||1.41|0.84|
70903551|NCT02567825|141295625|SUPERIORITY|The analysis was ITT. The participants are randomized children with at least one episode of AOM late during the respiratory season at which a nasopharyngeal or throat culture is obtained.|Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.69|1.95|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator.|||1.95|0.69|
70903552|NCT02567825|141295626|SUPERIORITY||Difference of least-squares means|0.25|||||TWO_SIDED|95.0|-0.06|0.56|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean parental satisfaction score||0.56|-0.06|
70903553|NCT02567825|141295627|SUPERIORITY||Risk Ratio (RR)|1.07|||||TWO_SIDED|95.0|0.98|1.18|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of parent reports indicating at least one health care encounter since the previous study visit.||1.18|0.98|
70903554|NCT02567825|141295628|SUPERIORITY|Reports for which the parent did not answer the question were excluded from the analysis.|Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.88|1.41|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of parent reports indicating a parent missed work due to child's illness.||1.41|0.88|
70903555|NCT02567825|141295629|SUPERIORITY|Reports indicating the parent did not answer the question were excluded from the analysis.|Risk Ratio (RR)|1.15|||||TWO_SIDED|95.0|0.89|1.48|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of parent reports indicating the need for special childcare arrangements due to child's illness.||1.48|0.89|
70903556|NCT02567825|141295630|SUPERIORITY||Difference of least-square means|-0.05|||||TWO_SIDED|95.0|-0.13|0.02|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean OM-6 survey score||0.02|-0.13|
70903557|NCT02567825|141295630|SUPERIORITY||Difference of least-square means|0.06|||||TWO_SIDED|95.0|-0.13|0.24|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean OM-6 survey--children's overall QOL score.||0.24|-0.13|
70903558|NCT02567825|141295631|SUPERIORITY||Difference of least-square means|-0.04|||||TWO_SIDED|95.0|-1.55|1.47|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean caregiver impact questionnaire score.||1.47|-1.55|
70903559|NCT02567825|141295631|SUPERIORITY||Difference of least-square means|0.03|||||TWO_SIDED|95.0|-0.14|0.2|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean caregiver impact questionnaire--caregiver's overall QOL score.||0.20|-0.14|
70903560|NCT00868699|141295667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.17|<|0.001|||||||Mixed Models Analysis||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.|||||<0.001
70903561|NCT00868699|141295667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.17|<|0.001|||||||Mixed Models Analysis||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.|||||<0.001
70903562|NCT00868699|141295668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.143|<|0.001|||||||Mixed Models Analysis||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.|||||<0.001
70903563|NCT00868699|141295668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.143|<|0.001|||||||Mixed Models Analysis||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.|||||<0.001
70903564|NCT00868699|141295669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|1.05||0.003|||||||ANCOVA||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.|||||0.003
70903565|NCT00868699|141295669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|1.01|<|0.001|||||||ANCOVA||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.|||||<0.001
70903566|NCT04091360|141295688|OTHER||GeoMean Ratio|1.221|||<|0.0001|TWO_SIDED|95.0|1.163|1.281|||ANCOVA|||||1.281|1.163|<0.0001
70903567|NCT04091360|141295688|OTHER||GeoMean Ratio|1.203|||<|0.0001|TWO_SIDED|95.0|1.146|1.263|||ANCOVA|||||1.263|1.146|<0.0001
70903568|NCT04091360|141295688|OTHER||GeoMean Ratio|1.139|||<|0.0001|TWO_SIDED|95.0|1.085|1.195|||ANCOVA|||||1.195|1.085|<0.0001
70903569|NCT04091360|141295689|OTHER||GeoMean Ratio|1.253|||<|0.0001|TWO_SIDED|95.0|1.151|1.363|||ANCOVA|||||1.363|1.151|<0.0001
70903570|NCT04091360|141295689|OTHER||GeoMean Ratio|1.146||||0.0022|TWO_SIDED|95.0|1.054|1.246|||ANCOVA|||||1.246|1.054|0.0022
70903571|NCT04091360|141295689|OTHER||GeoMean Ratio|1.102||||0.0295|TWO_SIDED|95.0|1.01|1.202|||ANCOVA|||||1.202|1.010|0.0295
70903572|NCT04091360|141295689|OTHER||GeoMean Ratio|1.129||||0.0098|TWO_SIDED|95.0|1.032|1.235|||ANCOVA|||||1.235|1.032|0.0098
70903573|NCT04091360|141295689|OTHER||GeoMean Ratio|1.028||||0.54|TWO_SIDED|95.0|0.939|1.125|||ANCOVA|||||1.125|0.939|0.54
70903574|NCT04091360|141295690|OTHER||GeoMean Ratio|1.228|||<|0.0001|TWO_SIDED|95.0|1.142|1.319|||ANCOVA|||||1.319|1.142|<0.0001
70903575|NCT04091360|141295690|OTHER||GeoMean Ratio|1.155||||0.0002|TWO_SIDED|95.0|1.075|1.24|||ANCOVA|||||1.240|1.075|0.0002
70903576|NCT04091360|141295690|OTHER||GeoMean Ratio|1.1||||0.0129|TWO_SIDED|95.0|1.022|1.184|||ANCOVA|||||1.184|1.022|0.0129
70903577|NCT04091360|141295690|OTHER||GeoMean Ratio|1.112||||0.0079|TWO_SIDED|95.0|1.03|1.201|||ANCOVA|||||1.201|1.030|0.0079
70903578|NCT04091360|141295690|OTHER||GeoMean Ratio|1.033||||0.39|TWO_SIDED|95.0|0.957|1.116|||ANCOVA|||||1.116|0.957|0.39
70903579|NCT04091360|141295691|OTHER||GeoMean Ratio|1.137|||<|0.0001|TWO_SIDED|95.0|1.073|1.204|||ANCOVA|||||1.204|1.073|<0.0001
70903580|NCT04091360|141295691|OTHER||GeoMean Ratio|1.091||||0.0041|TWO_SIDED|95.0|1.03|1.155|||ANCOVA|||||1.155|1.030|0.0041
70903581|NCT04091360|141295691|OTHER||GeoMean Ratio|1.019||||0.53|TWO_SIDED|95.0|0.96|1.081|||ANCOVA|||||1.081|0.960|0.53
70903582|NCT04091360|141295699|OTHER||GeoMean Ratio|1.21|||<|0.0001|TWO_SIDED|95.0|1.153|1.27|||ANCOVA|||||1.270|1.153|<0.0001
70903583|NCT04091360|141295699|OTHER||GeoMean Ratio|1.193|||<|0.0001|TWO_SIDED|95.0|1.136|1.252|||ANCOVA|||||1.252|1.136|<0.0001
70903584|NCT04091360|141295699|OTHER||GeoMean Ratio|1.124|||<|0.0001|TWO_SIDED|95.0|1.071|1.179|||ANCOVA|||||1.179|1.071|<0.0001
70903585|NCT04091360|141295700|OTHER||GeoMean Ratio|1.139|||<|0.0001|TWO_SIDED|95.0|1.087|1.194|||ANCOVA|||||1.194|1.087|<0.0001
70903586|NCT04091360|141295700|OTHER||GeoMean Ratio|1.142|||<|0.0001|TWO_SIDED|95.0|1.089|1.197|||ANCOVA|||||1.197|1.089|<0.0001
70903587|NCT04091360|141295700|OTHER||GeoMean Ratio|1.08||||0.0018|TWO_SIDED|95.0|1.031|1.132|||ANCOVA|||||1.132|1.031|0.0018
70903588|NCT04091360|141295701|OTHER||GeoMean Ratio|1.08||||0.0066|TWO_SIDED|95.0|1.022|1.14|||ANCOVA|||||1.140|1.022|0.0066
70903589|NCT04091360|141295701|OTHER||GeoMean Ratio|1.074||||0.0115|TWO_SIDED|95.0|1.017|1.134|||ANCOVA|||||1.134|1.017|0.0115
70903590|NCT04091360|141295701|OTHER||GeoMean Ratio|1.037||||0.18|TWO_SIDED|95.0|0.982|1.096|||ANCOVA|||||1.096|0.982|0.18
70903591|NCT04091360|141295702|OTHER||GeoMean Ratio|1.162|||<|0.0001|TWO_SIDED|95.0|1.122|1.203|||ANCOVA|||||1.203|1.122|<0.0001
70903592|NCT04091360|141295702|OTHER||GeoMean Ratio|1.15|||<|0.0001|TWO_SIDED|95.0|1.111|1.19|||ANCOVA|||||1.190|1.111|<0.0001
70903593|NCT04091360|141295702|OTHER||GeoMean Ratio|1.112|||<|0.0001|TWO_SIDED|95.0|1.074|1.152|||ANCOVA|||||1.152|1.074|<0.0001
70903594|NCT04091360|141295703|OTHER||GeoMean Ratio|1.157|||<|0.0001|TWO_SIDED|95.0|1.119|1.196|||ANCOVA|||||1.196|1.119|<0.0001
70903595|NCT04091360|141295703|OTHER||GeoMean Ratio|1.147|||<|0.0001|TWO_SIDED|95.0|1.11|1.186|||ANCOVA|||||1.186|1.110|<0.0001
70903596|NCT04091360|141295703|OTHER||GeoMean Ratio|1.105|||<|0.0001|TWO_SIDED|95.0|1.068|1.142|||ANCOVA|||||1.142|1.068|<0.0001
70903597|NCT04091360|141295704|OTHER||GeoMean Ratio|1.098|||<|0.0001|TWO_SIDED|95.0|1.059|1.137|||ANCOVA|||||1.137|1.059|<0.0001
70903598|NCT04091360|141295704|OTHER||GeoMean Ratio|1.111|||<|0.0001|TWO_SIDED|95.0|1.072|1.15|||ANCOVA|||||1.150|1.072|<0.0001
70903599|NCT04091360|141295704|OTHER||GeoMean Ratio|1.07||||0.0003|TWO_SIDED|5.0|1.033|1.109|||ANCOVA|||||1.109|1.033|0.0003
70903600|NCT04091360|141295705|OTHER||Median Difference (Final Values)|8.5||||0.47|TWO_SIDED||||||Hodges-Lehmann|||||||0.47
70903601|NCT04091360|141295705|OTHER||Mean Difference (Final Values)|18.0||||0.0059|TWO_SIDED||||||Hodges-Lehmann|||||||0.0059
70903602|NCT00744263|141295745|SUPERIORITY_OR_OTHER||Vaccine Efficacy|45.56||||0.0006|TWO_SIDED|95.2|21.82|62.49|||Clopper-Pearson method|||Vaccine efficacy against first event expressed as percentage. Vaccine efficacy = 1 - (proportion of participants who received 13vPnC with confirmed VT-CAP relative to those who received placebo). p-value and confidence intervals were derived using Clopper-Pearson method. The null hypothesis was vaccine efficacy = 0.||62.49|21.82|0.0006
70903603|NCT00744263|141295746|SUPERIORITY_OR_OTHER||Vaccine Efficacy|45.0||||0.0067|TWO_SIDED|95.2|14.21|65.31|||Clopper-Pearson method|||Vaccine efficacy against first event expressed as percentage. Vaccine efficacy = 1-(proportion of participants who received 13vPnC with confirmed VT-CAP relative to those who received placebo). p-value and confidence intervals were derived using Clopper-Pearson method. The null hypothesis was vaccine efficacy = 0.||65.31|14.21|0.0067
70903604|NCT00744263|141295747|SUPERIORITY_OR_OTHER||Vaccine Efficacy|75.0||||0.0005|TWO_SIDED|95.0|41.43|90.78|||Clopper-Pearson method|||Vaccine efficacy against first event expressed as percentage. Vaccine efficacy = 1-(proportion of participants who received 13vPnC with confirmed VT-CAP relative to those who received placebo). p-value and confidence intervals were derived using Clopper-Pearson method. The null hypothesis was vaccine efficacy = 0.||90.78|41.43|0.0005
70903605|NCT00744263|141295750|SUPERIORITY_OR_OTHER|||||||0.979|TWO_SIDED||||||Fisher Exact|||Fisher exact test, 2-sided, was used to calculate the p-value for the difference between vaccine groups in percentages of participants.||||0.979
70903606|NCT00744263|141295751|SUPERIORITY_OR_OTHER|||||||0.455|TWO_SIDED||||||Fisher Exact|||Fisher exact test, 2-sided, was used to calculate the p-value for the difference between vaccine groups in percentages of participants.||||0.455
70903607|NCT01121172|141295792|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|Non parametric test||||||0.001
70903608|NCT01121172|141295793|SUPERIORITY_OR_OTHER|||||||0.232|||||||Chi-squared|Chi-square test of frequency distribution amng obese study group and HapMap-CEU polymorphism distribution||||||0.232
70903609|NCT02100722|141295801|NON_INFERIORITY|Noninferiority of FFR-guided PCI to CABG was prespecified as an upper boundary of less than 1.65 for the 95% confidence interval of the hazard ratio.|Hazard Ratio (HR)|1.5||||0.35|TWO_SIDED|95.0|1.1|2.2|||Regression, Cox|||A sample of 712 patients per group (1424 for the entire trial) would be required in order to achieve 90% power to claim noninferiority||2.2|1.1|0.35
70903610|NCT02100722|141295804|OTHER||Hazard Ratio (HR)|1.7|||||TWO_SIDED|95.0|0.7|4.3||||||||4.3|0.7|
70903611|NCT02100722|141295805|OTHER||Hazard Ratio (HR)|1.5|||||TWO_SIDED|95.0|0.9|2.5|||||Hazard ratio for overall number of participants experiencing MI.|||2.5|0.9|
70903612|NCT02100722|141295806|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.3|2.4||||||||2.4|0.3|
70903613|NCT02100722|141295807|OTHER||Hazard Ratio (HR)|1.5|||||TWO_SIDED|95.0|0.9|2.3|||||Hazard ratio for overall number of participants experiencing repeat revascularization.|||2.3|0.9|
70903614|NCT02100722|141295808|OTHER||||||<|0.01|||||||Fisher Exact|||||||<0.01
70903615|NCT02100722|141295809|OTHER||||||<|0.04|||||||Fisher Exact|||||||<0.04
70903616|NCT02100722|141295810|OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
70903617|NCT02100722|141295813|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
70903618|NCT05652036|141295904|OTHER|||||||0.21||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in NPS score pre- and post-procedure||||0.21
70903619|NCT05652036|141295905|OTHER|||||||0.07||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in overactive bladder symptom bother before and after treatment||||.07
70903620|NCT05652036|141295905|OTHER|||||||0.16||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in overactive bladder HRQL mean before and after treatment||||0.16
70903621|NCT05652036|141295906|OTHER|||||||0.21|||||||Chi-squared|||Participant rated procedural satisfaction assessed 30-days post-procedure.||||0.21
70903622|NCT05652036|141295907|OTHER|Clinical Global Impression of Improvement scale sores reported by participants as very much improved after treatment||||||0.79|||||||Chi-squared|||||||0.79
70903623|NCT05652036|141295907|OTHER|Clinical Global Impression of Improvement scale sores reported by participants as much improved after treatment||||||0.27|||||||Chi-squared|||||||0.27
70903624|NCT05652036|141295907|OTHER|Clinical Global Impression of Improvement scale sores reported by participants as minimally improved after treatment||||||0.14|||||||Chi-squared|||||||0.14
70903625|NCT05652036|141295907|OTHER|Clinical Global Impression of Improvement scale sores reported by participants as no difference after treatment||||||1|||||||Chi-squared|||||||1.0
70903626|NCT05652036|141295908|OTHER|Rates of urinary retention observed in participants after BTX-A treatment.||||||0.5|||||||Chi-squared|||||||0.5
70903627|NCT05652036|141295908|OTHER|Rates of urinary tract infection observed in participants after BTX-A treatment.||||||0.24|||||||Chi-squared|||||||0.24
70903628|NCT05652036|141295908|OTHER|Rates of bleeding requiring evaluation observed in participants after BTX-A treatment.||||||1|||||||Chi-squared|||||||1.0
70903629|NCT05652036|141295908|OTHER|Rates of hematuria observed in participants after BTX-A treatment.||||||0.46|||||||Chi-squared|||||||0.46
70903630|NCT05652036|141295908|OTHER|Rates of bladder pain observed in participants after BTX-A treatment.||||||1|||||||Chi-squared|||||||1.0
70903631|NCT05652036|141295908|OTHER|Rates of ER department evaluations observed in participants after BTX-A treatment.||||||0.5|||||||Chi-squared|||||||0.5
70903632|NCT03500640|141295909|SUPERIORITY|||||||0.196||||||The a priori threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.196
70903633|NCT03500640|141295910|SUPERIORITY|||||||0.8||||||The a priori threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.800
70903634|NCT03500640|141295911|SUPERIORITY|||||||0.677|||||||t-test, 2 sided|||||||0.677
70903635|NCT03500640|141295912|SUPERIORITY|||||||0.349||||||The a priori threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.349
70903636|NCT03500640|141295913|SUPERIORITY|||||||0.891|||||||t-test, 2 sided|||||||0.891
70903637|NCT03500640|141295914|SUPERIORITY|||||||0.14||||||The a priori threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.140
70903638|NCT03500640|141295915|SUPERIORITY|||||||0.732|||||||t-test, 2 sided|||||||0.732
70903639|NCT03500640|141295916|SUPERIORITY|||||||0.637||||||The a priori threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.637
70903640|NCT03500640|141295917|SUPERIORITY|||||||0.521||||||The a priori threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.521
70903641|NCT03500640|141295918|SUPERIORITY|||||||0.083||||||The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.083
70903642|NCT03500640|141295919|SUPERIORITY|||||||0.778||||||The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.778
70903643|NCT03500640|141295920|SUPERIORITY|||||||0.982||||||The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.982
70903644|NCT03500640|141295921|SUPERIORITY|||||||0.081||||||The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.081
70903645|NCT03500640|141295922|SUPERIORITY|||||||0.712||||||The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.712
70903646|NCT03500640|141295923|SUPERIORITY|||||||0.371||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.371
70903647|NCT03500640|141295924|SUPERIORITY|||||||0.801||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.801
70903648|NCT03500640|141295925|SUPERIORITY|||||||0.069||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.069
70903649|NCT03500640|141295926|SUPERIORITY|||||||0.193||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.193
70903650|NCT03500640|141295927|SUPERIORITY|||||||0.197||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.197
70903651|NCT03500640|141295928|SUPERIORITY|||||||0.594||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.594
70903652|NCT03500640|141295929|SUPERIORITY|||||||0.328|||||||t-test, 2 sided|||||||0.328
70903653|NCT03500640|141295930|SUPERIORITY|||||||0.398||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.398
70903654|NCT03500640|141295931|SUPERIORITY|||||||0.288||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.288
70903655|NCT03500640|141295932|SUPERIORITY|||||||0.592||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.592
70903656|NCT03500640|141295933|SUPERIORITY|||||||0.805||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.805
70903657|NCT03500640|141295934|SUPERIORITY|||||||0.421||||||The a priori threshold for significance is 0.05|t-test, 2 sided|||The p value provided here is for the physical component summary score (PCS) only||||0.421
70903658|NCT03500640|141295935|SUPERIORITY|The p value provided here is for the physical component summary score (PCS) only||||||0.16|||||||t-test, 2 sided|||||||0.160
70903659|NCT03500640|141295936|SUPERIORITY|||||||0.196||||||The a priori threshold for significance is 0.05|t-test, 2 sided|||||||0.196
70903660|NCT03500640|141295937|SUPERIORITY|||||||0.532||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.532
70903661|NCT01279343|141295952|SUPERIORITY||Mean Difference (Final Values)|-3.1||||0.03|TWO_SIDED|95.0|-5.9|-0.3|||t-test, 2 sided|||||-0.3|-5.9|0.03
70964230|NCT03627767|141433765|SUPERIORITY||LSM difference|0.0|||=|0.9207|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|||Pruritus VAS: Week 12: The least squares mean (LSM) differences between treatment groups were derived from the statistical model. Mixed model repeated measure (MMRM) contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-0.3|= 0.9207
70964231|NCT03627767|141433765|SUPERIORITY||LSM difference|0.0|||=|0.9998|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|||Pruritus VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-0.3|= 0.9998
70964232|NCT03627767|141433765|SUPERIORITY||LSM difference|0.0|||||TWO_SIDED|95.0|-0.3|0.3||||||Pruritus VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-0.3|
70964233|NCT03627767|141433765|SUPERIORITY||LSM difference|-2.1|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.7|||Mixed Models Analysis|||Pruritus VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.7|-2.5|< 0.0001
70964234|NCT03627767|141433765|SUPERIORITY||LSM difference|-3.2|||<|0.0001|TWO_SIDED|95.0|-3.6|-2.8|||Mixed Models Analysis|||Pruritus VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-2.8|-3.6|< 0.0001
70964235|NCT03627767|141433765|SUPERIORITY||LSM difference|-1.1|||||TWO_SIDED|95.0|-1.4|-0.7||||||Pruritus VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.7|-1.4|
70964236|NCT03627767|141433765|SUPERIORITY||LSM difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-2.0|-0.8|||Mixed Models Analysis|||Pruritus VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.8|-2.0|< 0.0001
70964237|NCT03627767|141433765|SUPERIORITY||LSM difference|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.3|||Mixed Models Analysis|||Pruritus VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.3|-2.5|< 0.0001
70964238|NCT03627767|141433765|SUPERIORITY||LSM difference|-0.5|||||TWO_SIDED|95.0|-0.9|-0.1||||||Pruritus VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.1|-0.9|
70964239|NCT03627767|141433765|SUPERIORITY||LSM difference|-1.0|||=|0.0039|TWO_SIDED|95.0|-1.7|-0.3|||Mixed Models Analysis|||Pruritus VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-1.7|= 0.0039
70964240|NCT03627767|141433765|SUPERIORITY||LSM difference|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.2|||Mixed Models Analysis|||Pruritus VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.2|-2.5|< 0.0001
70964241|NCT03627767|141433765|SUPERIORITY||LSM difference|-0.8|||||TWO_SIDED|95.0|-1.3|-0.4||||||Pruritus VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.4|-1.3|
70964242|NCT03627767|141433765|SUPERIORITY||LSM difference|-0.5|||=|0.1488|TWO_SIDED|95.0|-1.2|0.2|||Mixed Models Analysis|||Pruritus VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-1.2|= 0.1488
70964243|NCT03627767|141433765|SUPERIORITY||LSM difference|-1.3|||=|0.0003|TWO_SIDED|95.0|-2.0|-0.6|||Mixed Models Analysis|||Pruritus VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.6|-2.0|= 0.0003
70964244|NCT03627767|141433765|SUPERIORITY||LSM difference|-0.8|||||TWO_SIDED|95.0|-1.2|-0.3||||||Pruritus VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-1.2|
70964245|NCT03627767|141433765|SUPERIORITY||LSM difference|0.0|||=|0.9294|TWO_SIDED|95.0|-0.2|0.2|||Mixed Models Analysis|||Sleep Loss VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-0.2|= 0.9294
70964246|NCT03627767|141433765|SUPERIORITY||LSM difference|-0.1|||=|0.4081|TWO_SIDED|95.0|-0.3|0.1|||Mixed Models Analysis|||Sleep Loss VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-0.3|= 0.4081
70964247|NCT03627767|141433765|SUPERIORITY||LSM difference|-0.1|||||TWO_SIDED|95.0|-0.3|0.1||||||Sleep Loss VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-0.3|
70964248|NCT03627767|141433765|SUPERIORITY||LSM difference|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.1|-1.4|||Mixed Models Analysis|||Sleep Loss VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.4|-2.1|< 0.0001
70964249|NCT03627767|141433765|SUPERIORITY||LSM difference|-2.3|||<|0.0001|TWO_SIDED|95.0|-2.7|-2.0|||Mixed Models Analysis|||Sleep Loss VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-2.0|-2.7|< 0.0001
70964250|NCT03627767|141433765|SUPERIORITY||LSM difference|-0.6|||||TWO_SIDED|95.0|-0.9|-0.2||||||Sleep Loss VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.2|-0.9|
70964251|NCT03627767|141433765|SUPERIORITY||LSM difference|-0.7|||=|0.0035|TWO_SIDED|95.0|-1.2|-0.2|||Mixed Models Analysis|||Sleep Loss VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.2|-1.2|= 0.0035
70964252|NCT03627767|141433765|SUPERIORITY||LSM difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.7|||Mixed Models Analysis|||Sleep Loss VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.7|-1.6|< 0.0001
70964253|NCT03627767|141433765|SUPERIORITY||LSM difference|-0.5|||||TWO_SIDED|95.0|-0.8|-0.1||||||Sleep Loss VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.1|-0.8|
70964254|NCT03627767|141433765|SUPERIORITY||LSM difference|-0.7|||=|0.0136|TWO_SIDED|95.0|-1.2|-0.1|||Mixed Models Analysis|||Sleep Loss VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.1|-1.2|= 0.0136
70964255|NCT03627767|141433765|SUPERIORITY||LSM difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.6|||Mixed Models Analysis|||Sleep Loss VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.6|-1.6|< 0.0001
70964256|NCT03627767|141433765|SUPERIORITY||LSM difference|-0.4|||||TWO_SIDED|95.0|-0.8|0.0||||||Sleep Loss VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.0|-0.8|
70964257|NCT03627767|141433765|SUPERIORITY||LSM difference|-0.3|||=|0.2887|TWO_SIDED|95.0|-1.0|0.3|||Mixed Models Analysis|||Sleep Loss VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-1.0|= 0.2887
70964258|NCT03627767|141433765|SUPERIORITY||LSM difference|-1.0|||=|0.0025|TWO_SIDED|95.0|-1.6|-0.3|||Mixed Models Analysis|||Sleep Loss VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-1.6|= 0.0025
70964259|NCT03627767|141433765|SUPERIORITY||LSM difference|-0.6|||||TWO_SIDED|95.0|-1.0|-0.2||||||Sleep Loss VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.2|-1.0|
70964260|NCT03627767|141433766|SUPERIORITY||Difference in percentage|1.0|||=|0.4244|TWO_SIDED|95.0|-1.4|3.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||3.4|-1.4|= 0.4244
70964261|NCT03627767|141433766|SUPERIORITY||Difference in percentage|-0.3|||=|0.8092|TWO_SIDED|95.0|-3.1|2.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||2.4|-3.1|= 0.8092
70964262|NCT03627767|141433766|SUPERIORITY||Difference in percentage|-1.5|||||TWO_SIDED|95.0|-4.1|1.0||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||1.0|-4.1|
70964263|NCT03627767|141433766|SUPERIORITY||Difference in percentage|46.7|||<|0.0001|TWO_SIDED|95.0|39.2|54.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||54.2|39.2|< 0.0001
70964264|NCT03627767|141433766|SUPERIORITY||Difference in percentage|63.6|||<|0.0001|TWO_SIDED|95.0|57.2|70.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||70.0|57.2|< 0.0001
70964265|NCT03627767|141433766|SUPERIORITY||Difference in percentage|17.0|||||TWO_SIDED|95.0|10.4|23.5||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||23.5|10.4|
70964266|NCT03627767|141433766|SUPERIORITY||Difference in percentage|41.3|||<|0.0001|TWO_SIDED|95.0|33.9|48.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||48.7|33.9|< 0.0001
70964267|NCT03627767|141433766|SUPERIORITY||Difference in percentage|59.9|||<|0.0001|TWO_SIDED|95.0|53.1|66.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||66.7|53.1|< 0.0001
70964268|NCT03627767|141433766|SUPERIORITY||Difference in percentage|18.7|||||TWO_SIDED|95.0|10.8|26.6||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||26.6|10.8|
70964269|NCT03627767|141433766|SUPERIORITY||Difference in percentage|37.0|||<|0.0001|TWO_SIDED|95.0|29.6|44.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||44.4|29.6|< 0.0001
70964270|NCT03627767|141433766|SUPERIORITY||Difference in percentage|54.6|||<|0.0001|TWO_SIDED|95.0|47.6|61.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||61.7|47.6|< 0.0001
70964271|NCT03627767|141433766|SUPERIORITY||Difference in percentage|17.7|||||TWO_SIDED|95.0|9.4|26.0||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||26.0|9.4|
70964272|NCT03627767|141433766|SUPERIORITY||Difference in percentage|30.0|||<|0.0001|TWO_SIDED|95.0|22.6|37.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||37.4|22.6|< 0.0001
70964273|NCT03627767|141433766|SUPERIORITY||Difference in percentage|50.9|||<|0.0001|TWO_SIDED|95.0|43.8|58.1||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||58.1|43.8|< 0.0001
70964274|NCT03627767|141433766|SUPERIORITY||Difference in percentage|21.1|||||TWO_SIDED|95.0|12.8|29.5||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||29.5|12.8|
70964275|NCT03627767|141433767|SUPERIORITY||Difference in percentage|1.4|||=|0.7232|TWO_SIDED|95.0|-6.1|8.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||8.8|-6.1|= 0.7232
70964276|NCT03627767|141433767|SUPERIORITY||Difference in percentage|-2.2|||=|0.5694|TWO_SIDED|95.0|-9.8|5.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||5.4|-9.8|= 0.5694
70964277|NCT03627767|141433767|SUPERIORITY||Difference in percentage|-3.7|||||TWO_SIDED|95.0|-11.2|3.8||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||3.8|-11.2|
70903662|NCT01279343|141295953|SUPERIORITY||Risk Ratio (RR)|0.99||||0.96|TWO_SIDED|95.0|0.8|1.23|||Chi-squared|||Comparison of vaginal delivery between groups.||1.23|.80|0.96
70903663|NCT01279343|141295953|SUPERIORITY||Risk Ratio (RR)|1.03||||0.9|TWO_SIDED|95.0|0.57|1.9|||Chi-squared|||Cesarean deliveries were compared between the groups.||1.90|0.57|0.90
70903664|NCT03245255|141295962|OTHER|Correlation analysis|Pearson Correlation Coefficient|-0.8|STANDARD_DEVIATION|0.1|||TWO_SIDED|||||||||||||
70903665|NCT04765735|141295964|SUPERIORITY||||||<|0.001||||||"It is hypothesized that the proportion of subjects with a reduction in overstimulation sensation during CL compared to OL period exceeds a performance goal of 50%.~H0: p ≤ 50% HA: p \> 50%"|Binomial Exact Test|||||||<0.001
70903666|NCT01250119|141295971|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for histopathology; Univariate analysis.||||||0.0000
70903667|NCT01250119|141295971|SUPERIORITY_OR_OTHER|||||||0.1038|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for histopathology; Multivariate analysis (6 main effects only).||||||0.1038
70903668|NCT01250119|141295971|SUPERIORITY_OR_OTHER|||||||0.0588|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for stage of disease; Univariate analysis.||||||0.0588
70903669|NCT01250119|141295971|SUPERIORITY_OR_OTHER|||||||0.4802|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for stage of disease; Multivariate analysis (6 main effects only).||||||0.4802
70903670|NCT01250119|141295971|SUPERIORITY_OR_OTHER|||||||0.0147|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for age at consent; Multivariate analysis (6 main effects only).||||||0.0147
70903671|NCT01250119|141295971|SUPERIORITY_OR_OTHER|||||||0.1181|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for age at consent; Multivariate analysis (6 main effects only).||||||0.1181
70903672|NCT01250119|141295971|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for gender; Univariate analysis.||||||0.0000
70903673|NCT01250119|141295971|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for gender; Multivariate analysis (6 main effects only).||||||0.0006
70903674|NCT01250119|141295971|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for race; Univariate analysis.||||||0.0004
70903675|NCT01250119|141295971|SUPERIORITY_OR_OTHER|||||||0.3371|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for race; Multivariate analysis (6 main effects only).||||||0.3371
70903676|NCT01250119|141295971|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for smoking history; Univariate analysis.||||||0.0000
70903677|NCT01250119|141295971|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for smoking history; Multivariate analysis (6 main effects only).||||||0.0001
70903678|NCT02887989|141295983|SUPERIORITY|||||||0.657|||||||t-test, 2 sided|||||||.6570
70903679|NCT02887989|141295984|SUPERIORITY|||||||0.6339|||||||t-test, 2 sided|||||||.6339
70903680|NCT00708526|141295995|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||t-test, 2 sided|A Bonferroni correction was used.||We compared times for discharge criteria after general anesthesia with and without the QED.||||>0.05
70903681|NCT00708526|141295996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||95.0|||||t-test, 2 sided|||The effect of the use of hypercapnia and increased ventilation on the time to recovery events was compared using multivariate analysis of variance with the Hotelling's two sample T2.-test and the two-tailed unpaired t-test; individual comparisons were by Bonferroni adjusted two tailed unpaired t-tests. The data was tested for normality before identifying statistical significance.||||0.039
70903682|NCT02674490|141296005|SUPERIORITY|||||||0.54||||||Threshold for significance is two-sided alpha of 0.05.|Regression, Linear|The primary analysis was adjusted for aphasia type (Anomia, Broca, or other type), baseline aphasia severity (AQ), and age.||Sample Size Determination If sample size in each group is 20, we will have 89% power to detect a difference in means of 23 (the difference between A-tDCS mean change in accuracy of 33 and a sham mean change in accuracy of 10) assuming that the SD of change for both groups is 22.2 using a two group t-test with a two-sided alpha of 0.05.||||0.54
70903683|NCT03469349|141296090|SUPERIORITY||Least square mean difference|29.19|STANDARD_ERROR_OF_MEAN|10.083||0.0041|TWO_SIDED|95.0|9.35|49.02|||MMRM|||Least squares means, p-values were obtained using a mixed model for repeated measures (MMRM) analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||49.02|9.35|0.0041
70903684|NCT03469349|141296091|SUPERIORITY||Least square mean difference|15.86|STANDARD_ERROR_OF_MEAN|7.814||0.0431|TWO_SIDED|95.0|0.49|31.24|||MMRM|||Week 2: Least squares means, p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||31.24|0.49|0.0431
70903685|NCT03469349|141296091|SUPERIORITY||Least square mean difference|35.51|STANDARD_ERROR_OF_MEAN|12.48||0.0047|TWO_SIDED|95.0|10.96|60.05|||MMRM|||Week 24: Least squares means, p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||60.05|10.96|0.0047
70903686|NCT03469349|141296092|SUPERIORITY|||||||0.0227|||||||MMRM|||Week 2: p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.0227
70903687|NCT03469349|141296092|SUPERIORITY|||||||0.0007|||||||MMRM|||Week 12: p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.0007
70903688|NCT03469349|141296092|SUPERIORITY|||||||0.0023|||||||MMRM|||Week 24: p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.0023
70903689|NCT03469349|141296093|NON_INFERIORITY|As the sample size was too small, clinically significant difference in actovegin and placebo could not be defined, the non-inferiority margin was defined as priori based on clinical reasoning.||||||0.9592||||||p-values were obtained using logistic regression adjusting for treatment.|Regression, Logistic|||Week 12||||0.9592
70903690|NCT03469349|141296093|NON_INFERIORITY|As the sample size was too small, clinically significant difference in actovegin and placebo could not be defined, the non-inferiority margin was defined as priori based on clinical reasoning.||||||0.5823||||||p-values were obtained using logistic regression adjusting for treatment.|Regression, Logistic|||Week 24||||0.5823
70964278|NCT03627767|141433767|SUPERIORITY||Difference in percentage|29.0|||<|0.0001|TWO_SIDED|95.0|22.2|35.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||35.8|22.2|< 0.0001
70964279|NCT03627767|141433767|SUPERIORITY||Difference in percentage|57.9|||<|0.0001|TWO_SIDED|95.0|51.2|64.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||64.5|51.2|< 0.0001
70964280|NCT03627767|141433767|SUPERIORITY||Difference in percentage|28.9|||||TWO_SIDED|95.0|20.8|37.0||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||37.0|20.8|
70964281|NCT03627767|141433767|SUPERIORITY||Difference in percentage|30.5|||<|0.0001|TWO_SIDED|95.0|23.9|37.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||37.2|23.9|< 0.0001
70964282|NCT03627767|141433767|SUPERIORITY||Difference in percentage|48.9|||<|0.0001|TWO_SIDED|95.0|42.1|55.6||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||55.6|42.1|< 0.0001
70964283|NCT03627767|141433767|SUPERIORITY||Difference in percentage|18.2|||||TWO_SIDED|95.0|9.8|26.6||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||26.6|9.8|
70964284|NCT03627767|141433767|SUPERIORITY||Difference in percentage|25.0|||<|0.0001|TWO_SIDED|95.0|18.4|31.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||31.5|18.4|< 0.0001
70964285|NCT03627767|141433767|SUPERIORITY||Difference in percentage|39.6|||<|0.0001|TWO_SIDED|95.0|32.7|46.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||46.5|32.7|< 0.0001
70964286|NCT03627767|141433767|SUPERIORITY||Difference in percentage|14.5|||||TWO_SIDED|95.0|6.3|22.8||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||22.8|6.3|
70964287|NCT03627767|141433767|SUPERIORITY||Difference in percentage|24.7|||<|0.0001|TWO_SIDED|95.0|18.1|31.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||31.2|18.1|< 0.0001
70964288|NCT03627767|141433767|SUPERIORITY||Difference in percentage|38.5|||<|0.0001|TWO_SIDED|95.0|31.6|45.3||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||45.3|31.6|< 0.0001
70964289|NCT03627767|141433767|SUPERIORITY||Difference in percentage|13.9|||||TWO_SIDED|95.0|5.6|22.3||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||22.3|5.6|
70964290|NCT03627767|141433775|SUPERIORITY||Difference in percentage|3.0|||=|0.4815|TWO_SIDED|95.0|-5.3|11.3||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||11.3|-5.3|= 0.4815
70964291|NCT03627767|141433775|SUPERIORITY||Difference in percentage|-1.8|||=|0.6748|TWO_SIDED|95.0|-10.3|6.6||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||6.6|-10.3|= 0.6748
70964292|NCT03627767|141433775|SUPERIORITY||Difference in percentage|-5.1|||||TWO_SIDED|95.0|-13.4|3.2||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||3.2|-13.4|
70964293|NCT03627767|141433775|SUPERIORITY||Difference in percentage|24.0|||<|0.0001|TWO_SIDED|95.0|17.8|30.3||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||30.3|17.8|< 0.0001
70964294|NCT03627767|141433775|SUPERIORITY||Difference in percentage|42.3|||<|0.0001|TWO_SIDED|95.0|35.6|49.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||49.0|35.6|< 0.0001
70964295|NCT03627767|141433775|SUPERIORITY||Difference in percentage|18.4|||||TWO_SIDED|95.0|10.2|26.6||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions||26.6|10.2|
70964296|NCT03627767|141433775|SUPERIORITY||Difference in percentage|24.6|||<|0.0001|TWO_SIDED|95.0|18.2|31.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||31.0|18.2|< 0.0001
70964297|NCT03627767|141433775|SUPERIORITY||Difference in percentage|40.5|||<|0.0001|TWO_SIDED|95.0|33.7|47.3||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||47.3|33.7|< 0.0001
70964298|NCT03627767|141433775|SUPERIORITY||Difference in percentage|15.9|||||TWO_SIDED|95.0|7.6|24.1||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||24.1|7.6|
70964299|NCT03627767|141433775|SUPERIORITY||Difference in percentage|18.8|||<|0.0001|TWO_SIDED|95.0|12.6|25.1||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.1|12.6|< 0.0001
70964300|NCT03627767|141433775|SUPERIORITY||Difference in percentage|34.5|||<|0.0001|TWO_SIDED|95.0|27.6|41.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||41.5|27.6|< 0.0001
70964301|NCT03627767|141433775|SUPERIORITY||Difference in percentage|15.6|||||TWO_SIDED|95.0|7.5|23.7||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||23.7|7.5|
70964302|NCT03627767|141433775|SUPERIORITY||Difference in percentage|18.7|||<|0.0001|TWO_SIDED|95.0|12.4|25.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.0|12.4|< 0.0001
70964303|NCT03627767|141433775|SUPERIORITY||Difference in percentage|32.3|||<|0.0001|TWO_SIDED|95.0|25.4|39.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||39.2|25.4|< 0.0001
70964304|NCT03627767|141433775|SUPERIORITY||Difference in percentage|13.7|||||TWO_SIDED|95.0|5.6|21.7||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||21.7|5.6|
70964305|NCT03627767|141433776|SUPERIORITY||LSM difference|0.1|||=|0.7373|TWO_SIDED|95.0|-0.5|0.7|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.7|-0.5|= 0.7373
70964306|NCT03627767|141433776|SUPERIORITY||LSM difference|-0.1|||=|0.8092|TWO_SIDED|95.0|-0.7|0.5|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.5|-0.7|= 0.8092
70964307|NCT03627767|141433776|SUPERIORITY||LSM difference|-0.2|||||TWO_SIDED|95.0|-0.8|0.4||||||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.4|-0.8|
70964308|NCT03627767|141433776|SUPERIORITY||LSM difference|-5.1|||<|0.0001|TWO_SIDED|95.0|-6.1|-4.0|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-4.0|-6.1|< 0.0001
70964309|NCT03627767|141433776|SUPERIORITY||LSM difference|-6.6|||<|0.0001|TWO_SIDED|95.0|-7.6|-5.5|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-5.5|-7.6|< 0.0001
70964310|NCT03627767|141433776|SUPERIORITY||LSM difference|-1.5|||||TWO_SIDED|95.0|-2.4|-0.6||||||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.6|-2.4|
70964311|NCT03627767|141433776|SUPERIORITY||LSM difference|-4.0|||<|0.0001|TWO_SIDED|95.0|-5.3|-2.7|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-2.7|-5.3|< 0.0001
70964312|NCT03627767|141433776|SUPERIORITY||LSM difference|-5.2|||<|0.0001|TWO_SIDED|95.0|-6.4|-3.9|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-3.9|-6.4|< 0.0001
70964313|NCT03627767|141433776|SUPERIORITY||LSM difference|-1.2|||||TWO_SIDED|95.0|-2.1|-0.3||||||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-2.1|
70964314|NCT03627767|141433776|SUPERIORITY||LSM difference|-1.9|||=|0.015|TWO_SIDED|95.0|-3.5|-0.4|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.4|-3.5|= 0.0150
70964315|NCT03627767|141433776|SUPERIORITY||LSM difference|-3.2|||<|0.0001|TWO_SIDED|95.0|-4.7|-1.7|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.7|-4.7|< 0.0001
70964316|NCT03627767|141433776|SUPERIORITY||LSM difference|-1.3|||||TWO_SIDED|95.0|-2.3|-0.3||||||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-2.3|
70964317|NCT03627767|141433776|SUPERIORITY||LSM difference|-0.8|||=|0.3616|TWO_SIDED|95.0|-2.4|0.9|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.9|-2.4|= 0.3616
70964318|NCT03627767|141433776|SUPERIORITY||LSM difference|-2.7|||=|0.0012|TWO_SIDED|95.0|-4.3|-1.1|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.1|-4.3|= 0.0012
70964319|NCT03627767|141433776|SUPERIORITY||LSM difference|-1.9|||||TWO_SIDED|95.0|-3.0|-0.8||||||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.8|-3.0|
70964320|NCT03627767|141433777|SUPERIORITY||LSM difference|0.6|||=|0.3339|TWO_SIDED|95.0|-0.6|1.8|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||1.8|-0.6|= 0.3339
70964321|NCT03627767|141433777|SUPERIORITY||LSM difference|0.5|||=|0.4653|TWO_SIDED|95.0|-0.8|1.7|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||1.7|-0.8|= 0.4653
70964322|NCT03627767|141433777|SUPERIORITY||LSM difference|-0.1|||||TWO_SIDED|95.0|-1.3|1.1||||||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||1.1|-1.3|
70964323|NCT03627767|141433777|SUPERIORITY||LSM difference|-4.3|||<|0.0001|TWO_SIDED|95.0|-6.2|-2.3|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-2.3|-6.2|< 0.0001
70964324|NCT03627767|141433777|SUPERIORITY||LSM difference|-6.2|||<|0.0001|TWO_SIDED|95.0|-8.2|-4.3|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-4.3|-8.2|< 0.0001
70964325|NCT03627767|141433777|SUPERIORITY||LSM difference|-2.0|||||TWO_SIDED|95.0|-3.6|-0.3||||||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-3.6|
70964326|NCT03627767|141433777|SUPERIORITY||LSM difference|0.1|||=|0.9083|TWO_SIDED|95.0|-1.8|2.1|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||2.1|-1.8|= 0.9083
70964327|NCT03627767|141433777|SUPERIORITY||LSM difference|-1.1|||=|0.2439|TWO_SIDED|95.0|-3.0|0.8|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.8|-3.0|= 0.2439
70964328|NCT03627767|141433777|SUPERIORITY||LSM difference|-1.2|||||TWO_SIDED|95.0|-2.6|0.1||||||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-2.6|
70964329|NCT03627767|141433777|SUPERIORITY||LSM difference|-0.3|||=|0.7405|TWO_SIDED|95.0|-2.4|1.7|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||1.7|-2.4|= 0.7405
70964330|NCT03627767|141433777|SUPERIORITY||LSM difference|-2.1|||=|0.041|TWO_SIDED|95.0|-4.1|-0.1|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.1|-4.1|= 0.0410
70964331|NCT03627767|141433777|SUPERIORITY||LSM difference|-1.7|||||TWO_SIDED|95.0|-3.1|-0.4||||||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.4|-3.1|
70964332|NCT03627767|141433777|SUPERIORITY||LSM difference|-1.0|||=|0.4026|TWO_SIDED|95.0|-3.5|1.4|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||1.4|-3.5|= 0.4026
70964333|NCT03627767|141433777|SUPERIORITY||LSM difference|-1.9|||=|0.0944|TWO_SIDED|95.0|-4.2|0.3|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-4.2|= 0.0944
70964334|NCT03627767|141433777|SUPERIORITY||LSM difference|-0.9|||||TWO_SIDED|95.0|-2.5|0.7||||||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.7|-2.5|
70964335|NCT03627767|141433778|SUPERIORITY||Hazard Ratio (HR)|0.27|||<|0.0001|TWO_SIDED|95.0|0.211|0.341||A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate p-value.|Log Rank|||A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% confidence interval (CI).||0.341|0.211|< 0.0001
70964336|NCT03627767|141433778|SUPERIORITY||Hazard Ratio (HR)|0.1|||<|0.0001|TWO_SIDED|95.0|0.07|0.136||A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.|Log Rank|||A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.||0.136|0.070|< 0.0001
70964337|NCT03627767|141433778|SUPERIORITY||Hazard Ratio (HR)|0.36|||<|0.0001|TWO_SIDED|95.0|0.255|0.516||A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.|Log Rank|||A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.||0.516|0.255|< 0.0001
70964338|NCT03627767|141433779|SUPERIORITY||LSM difference|0.1|||=|0.7556|TWO_SIDED|95.0|-0.4|0.6|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.6|-0.4|= 0.7556
70964339|NCT03627767|141433779|SUPERIORITY||LSM difference|0.1|||=|0.7484|TWO_SIDED|95.0|-0.4|0.6|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.6|-0.4|= 0.7484
70964340|NCT03627767|141433779|SUPERIORITY||LSM difference|0.0|||||TWO_SIDED|95.0|-0.5|0.5||||||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.5|-0.5|
70964341|NCT03627767|141433779|SUPERIORITY||LSM difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.6|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.6|-1.6|< 0.0001
70964342|NCT03627767|141433779|SUPERIORITY||LSM difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.9|-0.9|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.9|-1.9|< 0.0001
70964343|NCT03627767|141433779|SUPERIORITY||LSM difference|-0.3|||||TWO_SIDED|95.0|-0.7|0.1||||||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-0.7|
70964344|NCT03627767|141433779|SUPERIORITY||LSM difference|-0.6|||=|0.0242|TWO_SIDED|95.0|-1.2|-0.1|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.1|-1.2|= 0.0242
70964345|NCT03627767|141433779|SUPERIORITY||LSM difference|-0.9|||=|0.0012|TWO_SIDED|95.0|-1.4|-0.4|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.4|-1.4|= 0.0012
70964346|NCT03627767|141433779|SUPERIORITY||LSM difference|-0.3|||||TWO_SIDED|95.0|-0.6|0.1||||||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-0.6|
70964347|NCT03627767|141433779|SUPERIORITY||LSM difference|-0.6|||=|0.124|TWO_SIDED|95.0|-1.3|0.2|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-1.3|= 0.1240
70964348|NCT03627767|141433779|SUPERIORITY||LSM difference|-0.9|||=|0.0107|TWO_SIDED|95.0|-1.6|-0.2|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.2|-1.6|= 0.0107
70964349|NCT03627767|141433779|SUPERIORITY||LSM difference|-0.3|||||TWO_SIDED|95.0|-0.8|0.1||||||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-0.8|
70964350|NCT03627767|141433779|SUPERIORITY||LSM difference|-0.4|||=|0.3139|TWO_SIDED|95.0|-1.1|0.3|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-1.1|= 0.3139
70964351|NCT03627767|141433779|SUPERIORITY||LSM difference|-0.6|||=|0.0853|TWO_SIDED|95.0|-1.3|0.1|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-1.3|= 0.0853
70964352|NCT03627767|141433779|SUPERIORITY||LSM difference|-0.2|||||TWO_SIDED|95.0|-0.7|0.2||||||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-0.7|
70964353|NCT03627767|141433780|SUPERIORITY||LSM difference|0.4|||=|0.0674|TWO_SIDED|95.0|0.0|0.8|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.8|0.0|= 0.0674
70964354|NCT03627767|141433780|SUPERIORITY||LSM difference|0.3|||=|0.1437|TWO_SIDED|95.0|-0.1|0.7|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.7|-0.1|= 0.1437
70964355|NCT03627767|141433780|SUPERIORITY||LSM difference|-0.1|||||TWO_SIDED|95.0|-0.5|0.3||||||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-0.5|
70964356|NCT03627767|141433780|SUPERIORITY||LSM difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.8|-0.9|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.9|-1.8|< 0.0001
70964357|NCT03627767|141433780|SUPERIORITY||LSM difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.8|-0.9|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.9|-1.8|< 0.0001
70964358|NCT03627767|141433780|SUPERIORITY||LSM difference|0.0|||||TWO_SIDED|95.0|-0.4|0.4||||||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.4|-0.4|
70964359|NCT03627767|141433780|SUPERIORITY||LSM difference|-0.4|||=|0.1136|TWO_SIDED|95.0|-1.0|0.1|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-1.0|= 0.1136
70964360|NCT03627767|141433780|SUPERIORITY||LSM difference|-0.6|||=|0.0276|TWO_SIDED|95.0|-1.1|-0.1|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.1|-1.1|= 0.0276
70964361|NCT03627767|141433780|SUPERIORITY||LSM difference|-0.2|||||TWO_SIDED|95.0|-0.5|0.2||||||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-0.5|
70964362|NCT03627767|141433780|SUPERIORITY||LSM difference|-0.9|||=|0.0108|TWO_SIDED|95.0|-1.5|-0.2|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.2|-1.5|= 0.0108
70964363|NCT03627767|141433780|SUPERIORITY||LSM difference|-0.6|||=|0.0677|TWO_SIDED|95.0|-1.3|0.0|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.0|-1.3|= 0.0677
70964364|NCT03627767|141433780|SUPERIORITY||LSM difference|0.3|||||TWO_SIDED|95.0|-0.2|0.7||||||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.7|-0.2|
70964365|NCT03627767|141433780|SUPERIORITY||LSM difference|-0.5|||=|0.132|TWO_SIDED|95.0|-1.1|0.1|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-1.1|= 0.1320
70964366|NCT03627767|141433780|SUPERIORITY||LSM difference|-0.3|||=|0.2975|TWO_SIDED|95.0|-0.9|0.3|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-0.9|= 0.2975
70964367|NCT03627767|141433780|SUPERIORITY||LSM difference|0.2|||||TWO_SIDED|95.0|-0.2|0.6||||||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.6|-0.2|
70964368|NCT03627767|141433781|SUPERIORITY||LSM difference|-0.4|||=|0.3531|TWO_SIDED|95.0|-1.3|0.4|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.4|-1.3|= 0.3531
70964369|NCT03627767|141433781|SUPERIORITY||LSM difference|0.0|||=|0.9282|TWO_SIDED|95.0|-0.8|0.9|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.9|-0.8|= 0.9282
70964370|NCT03627767|141433781|SUPERIORITY||LSM difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3||||||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||1.3|-0.4|
70964371|NCT03627767|141433781|SUPERIORITY||LSM difference|-6.1|||<|0.0001|TWO_SIDED|95.0|-7.3|-5.0|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-5.0|-7.3|< 0.0001
70964372|NCT03627767|141433781|SUPERIORITY||LSM difference|-9.2|||<|0.0001|TWO_SIDED|95.0|-10.3|-8.1|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-8.1|-10.3|< 0.0001
70964373|NCT03627767|141433781|SUPERIORITY||LSM difference|-3.1|||||TWO_SIDED|95.0|-4.0|-2.1||||||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-2.1|-4.0|
70964374|NCT03627767|141433781|SUPERIORITY||LSM difference|-4.6|||<|0.0001|TWO_SIDED|95.0|-6.2|-2.9|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-2.9|-6.2|< 0.0001
70964375|NCT03627767|141433781|SUPERIORITY||LSM difference|-6.7|||<|0.0001|TWO_SIDED|95.0|-8.3|-5.1|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-5.1|-8.3|< 0.0001
70964376|NCT03627767|141433781|SUPERIORITY||LSM difference|-2.1|||||TWO_SIDED|95.0|-3.3|-0.9||||||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.9|-3.3|
70964377|NCT03627767|141433781|SUPERIORITY||LSM difference|-2.6|||=|0.0082|TWO_SIDED|95.0|-4.5|-0.7|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.7|-4.5|= 0.0082
70964378|NCT03627767|141433781|SUPERIORITY||LSM difference|-5.5|||<|0.0001|TWO_SIDED|95.0|-7.4|-3.6|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-3.6|-7.4|< 0.0001
70964379|NCT03627767|141433781|SUPERIORITY||LSM difference|-2.9|||||TWO_SIDED|95.0|-4.2|-1.6||||||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.6|-4.2|
70964380|NCT03627767|141433781|SUPERIORITY||LSM difference|-2.4|||=|0.0313|TWO_SIDED|95.0|-4.5|-0.2|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.2|-4.5|= 0.0313
70964381|NCT03627767|141433781|SUPERIORITY||LSM difference|-5.1|||<|0.0001|TWO_SIDED|95.0|-7.1|-3.0|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-3.0|-7.1|< 0.0001
70964382|NCT03627767|141433781|SUPERIORITY||LSM difference|-2.7|||||TWO_SIDED|95.0|-4.1|-1.3||||||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.3|-4.1|
70964383|NCT03627767|141433782|SUPERIORITY||LSM difference|-0.1|||=|0.4832|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-0.4|= 0.4832
70964384|NCT03627767|141433782|SUPERIORITY||LSM difference|-0.1|||=|0.6553|TWO_SIDED|95.0|-0.3|0.2|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-0.3|= 0.6553
70964385|NCT03627767|141433782|SUPERIORITY||LSM difference|0.0|||||TWO_SIDED|95.0|-0.2|0.3||||||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-0.2|
70964386|NCT03627767|141433782|SUPERIORITY||LSM difference|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.5|-1.1|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.1|-1.5|< 0.0001
70964387|NCT03627767|141433782|SUPERIORITY||LSM difference|-2.0|||<|0.0001|TWO_SIDED|95.0|-2.2|-1.7|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.7|-2.2|< 0.0001
70964388|NCT03627767|141433782|SUPERIORITY||LSM difference|-0.7|||||TWO_SIDED|95.0|-0.9|-0.4||||||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.4|-0.9|
70964389|NCT03627767|141433782|SUPERIORITY||LSM difference|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.7|-1.0|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.0|-1.7|< 0.0001
70964390|NCT03627767|141433782|SUPERIORITY||LSM difference|-2.2|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.8|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.8|-2.5|< 0.0001
70964391|NCT03627767|141433782|SUPERIORITY||LSM difference|-0.8|||||TWO_SIDED|95.0|-1.1|-0.5||||||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.5|-1.1|
70964392|NCT03627767|141433782|SUPERIORITY||LSM difference|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.6|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.6|-1.4|< 0.0001
70964393|NCT03627767|141433782|SUPERIORITY||LSM difference|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.2|-1.4|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.4|-2.2|< 0.0001
70964394|NCT03627767|141433782|SUPERIORITY||LSM difference|-0.8|||||TWO_SIDED|95.0|-1.1|-0.5||||||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.5|-1.1|
70964395|NCT03627767|141433782|SUPERIORITY||LSM difference|-0.8|||=|0.002|TWO_SIDED|95.0|-1.2|-0.3|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-1.2|= 0.0020
70964396|NCT03627767|141433782|SUPERIORITY||LSM difference|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.2|-1.2|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.2|-2.2|< 0.0001
70964397|NCT03627767|141433782|SUPERIORITY||LSM difference|-0.9|||||TWO_SIDED|95.0|-1.3|-0.6||||||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.6|-1.3|
70964398|NCT00785044|141433791|SUPERIORITY_OR_OTHER|Analysis was performed using the null hypothesis for the AUC stated as: H0: θ ≤A versus H1: θ \>A, where the AUC (θ) value was: 'A' selected based on the diagnostic utility desired from the use of myocardial 123 I-mIBG uptake measured using H/M ratio. A smooth parametric model of the ROC curve was fitted to the data. The AUC for the resulting model was calculated and 95% confidence interval for the AUC was reported. The hypothesis was tested using the Z-statistics at 'A' at level of 0.70.|Mean|0.581|||<|0.001|TWO_SIDED|95.0|0.532|0.63||At 0.05 level of significance.|Z-statistic|||"Analysis was performed on all HF participants from both groups AdreView™ - HF Group (With No Adverse Cardiac Events) and AdreView™ - HF Group (With Adverse Cardiac Events) based on H/M ratio."||0.630|0.532|<0.001
70964399|NCT01798992|141433799|SUPERIORITY_OR_OTHER_LEGACY|||||||0.685|TWO_SIDED||||||Fisher Exact|||The null hypothesis is that there is no difference in rate of LVEF improvement according to treatment group.||||0.685
70964400|NCT01798992|141433800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.071|TWO_SIDED||||||Fisher Exact|||The null hypothesis is that there is no difference in rate of LVEF improvement according to treatment group.||||0.071
70964401|NCT03823404|141433806|SUPERIORITY||||||<|0.0455||||||The interim analysis was conducted at significance level of 0.05 and the significance level was adjusted for final analysis.|mixed-effects model for repeated measure|||||||<0.0455
70964402|NCT03823404|141433807|SUPERIORITY||||||<|455|||||||Mixed Models Analysis|||||||<0455
70964403|NCT02308007|141433814|SUPERIORITY|||||||0.03|||||||Chi-squared, Corrected|||||||0.030
70964404|NCT02308007|141433814|SUPERIORITY|||||||0.073|||||||Chi-squared, Corrected|||||||0.073
70964405|NCT02308007|141433814|SUPERIORITY|||||||0.0204|||||||Cochran-Mantel-Haenszel|||Stratified by race (black, white, or other race)||||0.0204
70964406|NCT02308007|141433814|SUPERIORITY|||||||0.0493|||||||Cochran-Mantel-Haenszel|||Stratified by race (black, white, or other race)||||0.0493
70964407|NCT02308007|141433815|SUPERIORITY|||||||0.015|||||||Chi-squared, Corrected|||||||0.015
70964408|NCT02308007|141433815|SUPERIORITY|||||||0.193|||||||Chi-squared, Corrected|||Difference for Terconazole/metronidazole vaginal gel cures minus metronidazole vaginal gel cures||||0.193
70964409|NCT02308007|141433816|SUPERIORITY|||||||0.012|||||||Chi-squared, Corrected|||||||0.012
70964410|NCT02308007|141433816|SUPERIORITY|||||||0.918|||||||Chi-squared, Corrected|||||||0.918
70964411|NCT00528567|141433825|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.181|TWO_SIDED|95.0|0.72|1.07|||Log Rank|Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.||||1.07|0.72|0.1810
70964412|NCT00528567|141433827|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.5247|TWO_SIDED|95.0|0.74|1.17|||Log Rank|Stratification factors are Axillary nodal status, Choice of adjuvant chemotherapy, Hormone receptor status, Surgery||||1.17|0.74|0.5247
70964413|NCT00528567|141433829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.1966|TWO_SIDED|95.0|0.71|1.07|||Log Rank||Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.|||1.07|0.71|0.1966
70964414|NCT00528567|141433830|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.2318|TWO_SIDED|95.0|0.64|1.12|||Log Rank|||||1.12|0.64|0.2318
70964415|NCT00528567|141433833|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.2792|TWO_SIDED|95.0|0.72|1.1|||Log Rank||Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.|||1.10|0.72|0.2792
70964416|NCT00528567|141433835|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.1832|TWO_SIDED|95.0|0.72|1.07|||Log Rank||Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.|||1.07|0.72|0.1832
70964417|NCT00528567|141433837|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.3309|TWO_SIDED|95.0|0.72|1.12|||Log Rank||Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.|||1.12|0.72|0.3309
70964418|NCT01191541|141433893|NON_INFERIORITY|The primary objective was to demonstrate the noninferiority of DNR alone to DNR+ARA-C in the rate of DFS at 2 years. Assuming a 95% rate of DFS in the two groups, a margin of -15% , 5% type 1 error, 80% power, 30 evaluable patients per group were required to draw a noninferiority conclusion.|||||<|0.05||||||the p-value is not adjusted|Log Rank|||The characteristics of all of the included patients were summarized using cross-tabulations (for categorical variables) and quantiles. Nonparametric tests were used to analyse comparisons between groups .EFS、disease-free survival (DFS) and OS were estimated using the Kaplan -Meier method, and log-rank tests were used. All P values were two-sided, and those with values of 0.05 or less were considered to be statistically significant.||||<0.05
70964419|NCT04464265|141433908|OTHER|Our study adopted a within-subject design, which is not a randomized controlled trial (RCT). The P-value below indicates if propofol administration has a statistically significant impact on the brain activity in response to sensory stimuli.|Mean Difference (Net)|-3.0|STANDARD_DEVIATION|2.0|<|0.001|TWO_SIDED|||||The threshold for statistical significance was p=0.05. The p-value was not adjusted for multiple comparisons, as only one comparison was performed.|t-test, 2 sided||Difference = BOLD Response During Sedation - BOLD Response During Baseline|The null hypothesis is no difference in BOLD response between sedated state and baseline. For an fMRI study of cognitive function, Desmond and Glover (J. Neurosci. Methods., 2002) reported that about 25 subjects are necessary to achieve 80% power for a 0.5% increase of activity. We analyzed 27 subjects that fulfilled the suggested optimal group size for reliable statistics in functional MRI studies (also see Thirion et al., Neuroimage, 2007).||||<0.001
70964420|NCT04464265|141433909|OTHER|Our study adopted a within-subject design, which is not a randomized controlled trial (RCT). The P-value below indicates if propofol administration has a statistically significant impact on the brain activity in response to sensory stimuli.|Mean Difference (Net)|-2.72|STANDARD_DEVIATION|3.17|<|0.001|TWO_SIDED|||||The threshold for statistical significance was p=0.05. The p-value was not adjusted for multiple comparisons, as only one comparison was performed.|t-test, 2 sided||Difference = Squeeze Pressure During Sedation - Squeeze Pressure During Baseline|||||<0.001
70964421|NCT01063829|141433910|SUPERIORITY_OR_OTHER|||||||0.007|||||||Fisher Exact|||||||0.007
70964422|NCT01063829|141433910|SUPERIORITY_OR_OTHER|||||||0.014|||||||Fisher Exact|||||||0.014
70964423|NCT01063829|141433910|SUPERIORITY_OR_OTHER|||||||0.321|||||||Fisher Exact|||||||0.321
70964424|NCT01063829|141433911|SUPERIORITY_OR_OTHER|||||||0.002|||||||Log Rank|||||||0.002
70964425|NCT01063829|141433911|SUPERIORITY_OR_OTHER|||||||0.126|||||||Log Rank|||||||0.126
70964426|NCT01063829|141433911|SUPERIORITY_OR_OTHER|||||||0.148|||||||Log Rank|||||||0.148
70964427|NCT01063829|141433912|SUPERIORITY_OR_OTHER|||||||0.007|||||||Fisher Exact|||||||0.007
70964428|NCT01063829|141433912|SUPERIORITY_OR_OTHER|||||||0.014|||||||Fisher Exact|||||||0.014
70964429|NCT01063829|141433912|SUPERIORITY_OR_OTHER|||||||0.321|||||||Fisher Exact|||||||0.321
70964430|NCT00056862|141433936|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||Null hypothesis: first phase decline in HCV RNA are the same for the two groups||||0.002
70964431|NCT00056862|141433938|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Null hypothesis: the second phase slopes of HCV RNA are the same for the two groups||||0.2
70964432|NCT00056862|141433939|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED|95.0|||||Log Rank|||Null hypothesis: the time to negativity for the two groups are same||||0.047
70964433|NCT00006392|141434061|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13|||<|0.01|TWO_SIDED|99.0|0.95|1.35||The p-value was adjusted for multiple comparisons.|Regression, Cox|||Per study design, with a sample size of 32,400 men, using a 1-sided alpha=.005 level (equivalent to a 2-sided alpha=.01 level) there was 96% power to detect a 25% reduction in prostate cancer for either agent vs. Placebo.||1.35|0.95|< .01
70903691|NCT03469349|141296094|NON_INFERIORITY|As the sample size was too small, clinically significant difference in actovegin and placebo could not be defined, the non-inferiority margin was defined as priori based on clinical reasoning.||||||0.9424||||||p-values were obtained using logistic regression adjusting for treatment.|Regression, Logistic|||||||0.9424
70903692|NCT03469349|141296095|SUPERIORITY|||||||0.3758|||||||MMRM|||Physical Health Score: Week 12; Least squares means, p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.3758
70903693|NCT03469349|141296095|SUPERIORITY|||||||0.1412|||||||MMRM|||Physical Health Score: Week 24; Least squares means, p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.1412
70903694|NCT03469349|141296095|SUPERIORITY|||||||0.1009|||||||MMRM|||Mental Health Score: Week 12; Least squares means, p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.1009
70903695|NCT03469349|141296095|SUPERIORITY|||||||0.0015|||||||MMRM|||Mental Health Score: Week 24; Least squares means, p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.0015
70903696|NCT03349268|141296106|SUPERIORITY|||||||0.23|||||||Poisson regression|||||||0.23
70903697|NCT01187329|141296107|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.11|TWO_SIDED|97.5|-2.87|0.48|||t-test, 2 sided|||||0.48|-2.87|0.11
70903698|NCT01187329|141296108|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.007|TWO_SIDED|97.5|-0.3|-0.01|||t-test, 2 sided|paired t-test||||-0.01|-0.3|0.007
70903699|NCT01187329|141296109|SUPERIORITY||Median Difference (Final Values)|-0.6||||0.57|TWO_SIDED|95.0|-2.6|1.5|||t-test, 2 sided|||||1.5|-2.6|0.57
70903700|NCT01187329|141296110|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.45|TWO_SIDED|95.0|-0.2|0.1|||t-test, 2 sided|||||0.1|-0.2|0.45
70903701|NCT00692406|141296111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0023|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
70903702|NCT00692406|141296112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1167|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
70903703|NCT00692406|141296113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0253|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
70903704|NCT00692406|141296114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1432|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
70903705|NCT00692406|141296115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0489|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
70903706|NCT00692406|141296116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0096|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
70903707|NCT00692406|141296117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0372|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
70903708|NCT00692406|141296118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
70903709|NCT02307513|141296136|SUPERIORITY||Difference in LS Mean|-92.6|||<|0.0001|TWO_SIDED|95.0|-130.59|-54.6|||ANCOVA|ANCOVA model with AUC W0-12 as the response variables; treatment arm, sex, region as factors and the number of oral ulcers at baseline as a covariate.|Treatment difference = Apremilast - Placebo|The AUC W0-12 for oral ulcer counts was compared between the placebo treatment group and the apremilast 30 BID treatment group using a 2-tailed parametric analysis of covariance (ANCOVA) test at the 0.05 significance level.||-54.60|-130.59|<0.0001
70903710|NCT02307513|141296137|SUPERIORITY||Difference in LS Mean|-24.8|||<|0.0001|TWO_SIDED|95.0|-32.8|-16.8|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.||||-16.8|-32.8|<0.0001
70903711|NCT02307513|141296138|SUPERIORITY||Difference in LS Mean|-11.94|||<|0.0001|TWO_SIDED|95.0|-16.2|-7.67|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.||||-7.67|-16.20|<0.0001
70903712|NCT02307513|141296139|SUPERIORITY||Difference in LS Means|-0.5||||0.0335|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.||||-0.0|-1.0|0.0335
70903713|NCT02307513|141296140|SUPERIORITY||Difference in LS Means|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.6|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.||||-0.6|-1.4|<0.0001
70903714|NCT02307513|141296141|SUPERIORITY||Difference in LS Means|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.||||-0.5|-1.3|<0.0001
70903715|NCT02307513|141296142|SUPERIORITY||Adjusted difference in percentages|25.1|||<|0.0001|TWO_SIDED|95.0|15.5|34.6|||Cochran-Mantel-Haenszel|2 sided p-value based on the CMH test adjusting for sex and region.|Adjusted difference was the weighted average of the treatment differences across the 4 strata of combined sex and region factors with the CMH weights.|||34.6|15.5|<0.0001
70964434|NCT00006392|141434061|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04|||<|0.01|TWO_SIDED|99.0|0.87|1.24||The p-value was adjusted for multiple comparisons.|Regression, Cox|||Per study design, with a sample size of 32,400 men, using a 1-sided alpha=.005 level (equivalent to a 2-sided alpha=.01 level) there was 96% power to detect a 25% reduction in prostate cancer for either agent vs. Placebo.||1.24|0.87|< .01
70964435|NCT00006392|141434061|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05|||<|0.01||99.0|0.88|1.25||The p-value was adjusted for multiple comparisons.|Regression, Cox|||Per study design, with a sample size of 32,400 men, using a 1-sided alpha=.005 level (equivalent to a 2-sided alpha=.01 level) there was 99% power to detect a 44% reduction in prostate cancer for combination vs. Placebo.||1.25|.88|< .01
70964436|NCT00006392|141434062|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||>|0.05||99.0|0.64|1.55||The trial was designed to study prostate cancer and lung cancer has a lower incidence rate, there was limited power to look at lung cancer incidence. A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|||1.55|.64|> .05
70964437|NCT00006392|141434062|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12|||>|0.01|TWO_SIDED|99.0|0.73|1.72||The trial was designed to study prostate cancer and lung cancer has a lower incidence rate, there was limited power to look at lung cancer incidence. A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|||1.72|0.73|> .01
70964438|NCT00006392|141434062|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16|||>|0.01|TWO_SIDED|99.0|0.9|1.16||The trial was designed to study prostate cancer and lung cancer has a lower incidence rate, there was limited power to look at lung cancer incidence. A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|||1.16|0.90|>.01
70964439|NCT00006392|141434063|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09|||>|0.05|TWO_SIDED|99.0|0.69|1.73||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The trial was designed to study prostate cancer and colorectal cancer has a lower incidence rate, there was limited power to look at colorectal cancer incidence.||1.73|0.69|> .05
70964440|NCT00006392|141434063|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05|||>|0.05|TWO_SIDED|99.0|0.66|1.67||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The trial was designed to study prostate cancer and colorectal cancer has a lower incidence rate, there was limited power to look at colorectal cancer incidence.||1.67|0.66|> .05
70964441|NCT00006392|141434063|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.28|||>|0.05|TWO_SIDED|99.0|0.82|2.0||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The trial was designed to study prostate cancer and colorectal cancer has a lower incidence rate, there was limited power to look at colorectal cancer incidence.||2.00|0.82|> .05
70964442|NCT00006392|141434064|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03|||>|0.05|TWO_SIDED|99.0|0.91|1.17||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The power to look at all cancer incidence is greater than 90%.||1.17|0.91|> .05
70964443|NCT00006392|141434064|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01|||>|0.05|TWO_SIDED|99.0|0.89|1.15||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The power to look at all cancer incidence is greater than 90%.||1.15|0.89|> .05
70964444|NCT00006392|141434064|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02|||>|0.05||99.0|0.9|1.16||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The power to look at all cancer incidence is greater than 90%.||1.16|0.90|> .05
70964445|NCT00006392|141434065|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93|||>|0.05||99.0|0.77|1.13||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo is the denominator.|Only results from overall survival are presented as the number of cancer-specific deaths is too few to be meaningful.||1.13|0.77|> .05
70964446|NCT00006392|141434065|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99|||>|0.05|TWO_SIDED|99.0|0.82|1.19||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|Only results from overall survival are presented as the number of cancer-specific deaths is too few to be meaningful.||1.19|0.82|> .05
70964447|NCT00006392|141434065|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||>|0.05|TWO_SIDED|99.0|0.77|1.13||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox|||Only results from overall survival are presented as the number of cancer-specific deaths is too few to be meaningful.||1.13|0.77|> .05
70964448|NCT00006392|141434066|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98|||>|0.05|TWO_SIDED|99.0|0.88|1.09||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Chi-squared||The placebo was the denominator.|||1.09|0.88|> .05
70964449|NCT00006392|141434066|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02|||>|0.05|TWO_SIDED|99.0|0.92|1.13||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Chi-squared||The placebo was the denominator.|||1.13|0.92|> .05
70964450|NCT00006392|141434066|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99|||>|0.05|TWO_SIDED|99.0|0.89|1.1||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Chi-squared||The placebo was the denominator.|||1.10|0.89|> .05
70964451|NCT01479829|141434104|SUPERIORITY||Chi-square value|5.3466||||0.02|TWO_SIDED||||||Chi-squared||The chi-square value with 1 degree of freedom was 5.3466.|The null hypothesis is that there is no difference in the response rate between patients assigned to the intervention cohort or control cohort.||||.02
70964452|NCT01479829|141434105|SUPERIORITY||Chi-square value|13.3821|||<|0.001|TWO_SIDED||||||Chi-squared||The chi-square value with 1 degree of freedom was 13.3821.|The null hypothesis is that there is no difference in the remission rate between patients assigned to the intervention cohort or control cohort.||||<.001
70964453|NCT01791803|141434112|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.6|||||TWO_SIDED|95.0|1.1|11.4||||||||11.4|1.1|
70964454|NCT01791803|141434112|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.4|||||TWO_SIDED|95.0|1.04|9.7||||||||9.7|1.04|
70964455|NCT01791803|141434113|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.0|||||TWO_SIDED|95.0|0.8|6.2||||Adjusted for gender, marital status, diagnosis at enrollment.||||6.2|0.8|
70964456|NCT01791803|141434113|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.3|||||TWO_SIDED|95.0|1.2|10.0||||||||10|1.2|
70964457|NCT01791803|141434114|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Comparison of smoking status at 12 weeks after hospitalization for a cardiac or pulmonary diagnosis||||< 0.001
70964458|NCT01791803|141434114|SUPERIORITY_OR_OTHER|||||||0.07|||||||ANOVA|||Comparison of smoking stars at 26 weeks after hospitalization for a cardiac or a pulmonary illness||||0.07
70964459|NCT00594516|141434146|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of (-2, 2). A prespecified equivalence margin of (-2,2) was used for equivalence analysis.|Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.09||||95.0|-0.09|0.28||||||Comparison of Tapentadol IR to ER analysis of variance model with factors for treatment, double blind cross-over period and subject.||0.28|-0.09|
70964460|NCT00088907|141434151|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Log Rank|||||||0.60
70964461|NCT00088907|141434152|SUPERIORITY_OR_OTHER|||||||0.19|||||||Log Rank|||||||0.19
70964462|NCT03426787|141434162|SUPERIORITY||Mean Difference (Final Values)|-12.30216|||<|0.001|TWO_SIDED|95.0|-18.95|-5.6531|||t-test, 2 sided|||||-5.6531|-18.95|<0.001
70964463|NCT03426787|141434163|SUPERIORITY||Mean Difference (Final Values)|-0.4717||||0.0463|TWO_SIDED|95.0|-0.9355|-0.00793|||t-test, 2 sided|||||-0.00793|-0.9355|0.0463
70964464|NCT03426787|141434164|SUPERIORITY||Median Difference (Final Values)|-1.936|||>|0.05|TWO_SIDED|95.0|-7.4086|3.5365|||t-test, 2 sided|||||3.5365|-7.4086|>0.05
70964465|NCT02217436|141434166|SUPERIORITY|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||||||0.98
70964466|NCT02217436|141434167|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
70964467|NCT00763971|141434211|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|-18.6|||<|0.001|TWO_SIDED|95.0|-21.5|-15.7|||ANCOVA|||||-15.7|-21.5|<0.001
70964468|NCT00763971|141434211|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|-13.0|||<|0.001|TWO_SIDED|95.0|-15.9|-10.2|||ANCOVA|||||-10.2|-15.9|<0.001
70964469|NCT00763971|141434212|SUPERIORITY_OR_OTHER_LEGACY||difference in percentages|63.6|||<|0.001|TWO_SIDED|95.0|53.0|74.1|||Cochran-Mantel-Haenszel|||||74.1|53.0|<0.001
70964470|NCT00763971|141434212|SUPERIORITY_OR_OTHER_LEGACY||difference in percentages|46.2|||<|0.001|TWO_SIDED|95.0|34.6|57.7|||Cochran-Mantel-Haenszel|||||57.7|34.6|<0.001
70964471|NCT00763971|141434213|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|-21.3|||<|0.001|TWO_SIDED|95.0|-25.5|-17.0|||ANCOVA|||||-17.0|-25.5|<0.001
70964472|NCT00763971|141434213|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|-15.1|||<|0.001|TWO_SIDED|95.0|-19.3|-10.9|||ANCOVA|||||-10.9|-19.3|<0.001
70964473|NCT00763971|141434215|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|8.8|||<|0.001|TWO_SIDED|95.0|6.1|11.5|||ANCOVA|||||11.5|6.1|<0.001
70964474|NCT00763971|141434215|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|7.3|||<|0.001|TWO_SIDED|95.0|4.6|10.0|||ANCOVA|||||10.0|4.6|<0.001
70964475|NCT00763971|141434216|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|-0.3|||<|0.001|TWO_SIDED|95.0|-0.4|-0.2|||ANCOVA|||||-0.2|-0.4|<0.001
70964476|NCT00763971|141434216|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|-0.2|||<|0.001|TWO_SIDED|95.0|-0.3|-0.1|||ANCOVA|||||-0.1|-0.3|<0.001
70964477|NCT04439071|141434222|OTHER|||||||0.949|||||||Log Rank|||Time to respiratory improvement was compared between treatment groups using stratified log-rank test.||||0.949
70964478|NCT04439071|141434241|OTHER|||||||0.033|||||||Log Rank|||Time to respiratory improvement was compared between treatment groups using stratified log-rank test.||||0.033
70964479|NCT02645760|141434242|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||It was calculated that 38 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% power to detect a difference of 2.26 points in mean 11-point NRS pain score between core stabilization exercise and conventional treatment from baseline to week 7.||||<0.001
70964480|NCT02645760|141434243|SUPERIORITY_OR_OTHER|||||||0.009|||||||ANCOVA|||It was calculated that 38 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% power to detect a difference of 2.68 points in mean disability score (RMDQ score) between core stabilization exercise and conventional treatment from baseline to week 7.||||0.009
70964481|NCT02645760|141434244|SUPERIORITY_OR_OTHER|||||||0.013|||||||ANCOVA|||It was calculated that 38 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% power to detect a difference of 0.79 centimeter in mean range of motion between core stabilization exercise and conventional treatment from baseline to week 7.||||0.013
70964482|NCT02645760|141434245|SUPERIORITY_OR_OTHER|||||||0.012|||||||ANCOVA|||It was calculated that 38 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% power to detect a difference of 0.30 centimeter in mean repositioning error between core stabilization exercise and conventional treatment from baseline to week 7.||||0.012
70964483|NCT00729781|141434251|SUPERIORITY_OR_OTHER||Percent of subjects with improvement|57.8||||0.19|ONE_SIDED|97.5|42.2||||One-sided, binomial exact test|||This study had two independent primary endpoints (cosmetic and functional improvement). Therefore, the assumed type I error rate for each was 2.5% in order to maintain an overall 5% type I error rate. For each endpoint, the percent of subjects with improvement of the total number implanted was to be compared to a rate of 50% using a one-sided, binomial exact test. If the p-value was \< 0.025, the objective would have been met.|||42.2|0.19
70964484|NCT00729781|141434252|SUPERIORITY_OR_OTHER||Percent of subjects with improvement|15.6|||>|0.99|ONE_SIDED|97.5|0.05||||One-sided, binomial exact test||||||0.05|>0.99
70964485|NCT01186796|141434281|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
70964486|NCT01186796|141434282|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|Two-way ANOVA in a 2x4 factorial nested design with repeated measures.||||||<0.05
70964487|NCT01186796|141434283|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||"Unit of mass secreted per burst is in ug/L. An automated deconvolution method was used and mathematically verified by direct statistical proof and empirically validated using hypothalamopituitary sampling and a simulated pulsatile time series."|ANOVA|Two-way ANOVA in a 2x4 factorial nested design with repeated measures.||||||<0.05
70964488|NCT01186796|141434284|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|Two-way ANOVA in a 2x4 factorial nested design with repeated measures.||||||<0.05
70964489|NCT01186796|141434285|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|Two-way ANOVA in a 2x4 factorial nested design with repeated measures.||||||<0.05
70964490|NCT01958788|141434300|SUPERIORITY_OR_OTHER||Cohen's d effect size|2.06|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment||||
70964491|NCT01958788|141434300|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.34|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
70964492|NCT01958788|141434300|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.37|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
70964493|NCT01958788|141434301|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.32|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment||||
70964494|NCT01958788|141434301|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.29|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
70964495|NCT01958788|141434301|SUPERIORITY_OR_OTHER||Cohen's d effect size|-0.15|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
70964496|NCT01958788|141434302|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.72|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment follow-up||||
70964497|NCT01958788|141434302|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.66|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
70964498|NCT01958788|141434302|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.07|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
70964499|NCT01958788|141434303|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.13|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment||||
70964500|NCT01958788|141434303|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.06|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
70964501|NCT01958788|141434303|SUPERIORITY_OR_OTHER||Cohen's d effect size|-0.18|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
70964502|NCT01958788|141434304|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.41|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment||||
70964503|NCT01958788|141434304|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.65|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
70964504|NCT01958788|141434304|SUPERIORITY_OR_OTHER||Cohen's d effect size|-0.7|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
70964505|NCT01958788|141434305|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.64|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment||||
70964506|NCT01958788|141434305|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.47|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
70964507|NCT01958788|141434305|SUPERIORITY_OR_OTHER||Cohen's d effect size|-0.56|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
70964508|NCT01958788|141434306|SUPERIORITY_OR_OTHER||Cohen's d effect size|2.08|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment||||
70964509|NCT01958788|141434306|SUPERIORITY_OR_OTHER||Cohen's d effect size|2.15|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
70964510|NCT01958788|141434306|SUPERIORITY_OR_OTHER||Cohen's d effect size|-0.55|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
70964511|NCT01936909|141434316|SUPERIORITY||||||>|0.2|||||||ANOVA|||This test reflects a comparison between baseline and 2 weeks (both rows).||||>0.20
70964512|NCT01936909|141434317|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Paired analysis versus baseline||||<0.01
70964513|NCT01936909|141434318|SUPERIORITY|Log-rank test||||||0.12|||||||Log Rank|||||||0.12
70964514|NCT00962390|141434319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.4678|TWO_SIDED|95.0|-0.5|1.1||Statistical testing was 2-sided and the 5% significant level was used.|ANCOVA|The ANCOVA included Baseline as covariate and factors for treatment and site.|S-equol treatment group minus placebo group.|Week 4, Treatment Effect||1.1|-0.5|0.4678
70964515|NCT00962390|141434319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.4892|TWO_SIDED|95.0|-0.5|1.1||Statistical testing was 2-sided and the 5% significant level was used.|ANCOVA|The ANCOVA included Baseline as covariate and factors for treatment and site.|S-equol treatment group minus placebo group.|Week 4, Treatment Effect||1.1|-0.5|0.4892
70964516|NCT00962390|141434319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.8185|TWO_SIDED|95.0|-0.8|1.0||Statistical testing was 2-sided and the 5% significant level was used.|ANCOVA|The ANCOVA included Baseline as covariate and factors for treatment and site.|S-equol treatment group minus placebo group.|Week 4, Treatment Effect||1.0|-0.8|0.8185
70964517|NCT00744211|141434333|SUPERIORITY_OR_OTHER||||||<|0.05||||||p\<0.05; Pairwise tests of individual groups means were compared by adjusted probabilities (Bonferroni method).|ANOVA|||||||<0.05
70964518|NCT00744211|141434334|SUPERIORITY_OR_OTHER|||||||0.001||||||Pairwise tests of individual groups means were compared by adjusted probabilities (Bonferroni method).|ANOVA|||||||0.001
70964519|NCT00744211|141434335|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70964520|NCT00744211|141434336|EQUIVALENCE|Chi-square tests for differences between groups.||||||0.015||||||P-value is associated with the hematological/lymphatic adverse event.|Chi-squared|||||||0.015
70964521|NCT03740997|141434341|OTHER||Mean Difference (Net)|16.2|STANDARD_DEVIATION|5.46||0.0008|TWO_SIDED|95.0|10.44|21.89|||Paired t-test|||Reader 1: Difference Between Non-contrast and OPTISON Dose Level 1||21.89|10.44|0.0008
70964522|NCT03740997|141434341|OTHER||Mean Difference (Net)|17.1|STANDARD_DEVIATION|13.49|<|0.0001|TWO_SIDED|95.0|11.11|23.07|||Paired t-test|||Reader 1: Difference Between Non-contrast and OPTISON Dose Level 1||23.07|11.11|<0.0001
70964523|NCT03740997|141434341|OTHER||Mean Difference (Net)|19.3|STANDARD_DEVIATION|6.5||0.0002|TWO_SIDED|95.0|13.28|25.3|||Paired t-test|||Reader 1: Difference Between Non-contrast and OPTISON Dose Level 2||25.30|13.28|0.0002
70964524|NCT03740997|141434341|OTHER||Mean Difference (Net)|18.5|STANDARD_DEVIATION|11.68|<|0.0001|TWO_SIDED|95.0|13.47|23.57|||Paired t-test|||Reader 1: Difference Between Non-contrast and OPTISON Dose Level 2||23.57|13.47|<0.0001
70964525|NCT03740997|141434341|OTHER||Mean Difference (Net)|19.8|STANDARD_DEVIATION|3.06|<|0.0001|TWO_SIDED|95.0|16.62|23.05|||Paired t-test|||Reader 2: Difference Between Non-contrast and OPTISON Dose Level 1||23.05|16.62|<0.0001
70964526|NCT03740997|141434341|OTHER||Mean Difference (Net)|20.1|STANDARD_DEVIATION|13.38|<|0.0001|TWO_SIDED|95.0|14.16|26.03|||Paired t-test|||Reader 2: Difference Between Non-contrast and OPTISON Dose Level 1||26.03|14.16|<0.0001
70964527|NCT03740997|141434341|OTHER||Mean Difference (Net)|22.0|STANDARD_DEVIATION|2.77|<|0.0001|TWO_SIDED|95.0|19.44|24.56|||Paired t-test|||Reader 2: Difference Between Non-contrast and OPTISON Dose Level 2||24.56|19.44|<0.0001
70964528|NCT03740997|141434341|OTHER||Mean Difference (Net)|21.2|STANDARD_DEVIATION|13.34|<|0.0001|TWO_SIDED|95.0|15.45|26.99|||Paired t-test|||Reader 2: Difference Between Non-contrast and OPTISON Dose Level 2||26.99|15.45|<0.0001
70964529|NCT03740997|141434341|OTHER||Mean Difference (Net)|11.8|STANDARD_DEVIATION|9.35||0.0268|TWO_SIDED|95.0|2.02|21.64|||Paired t-test|||Reader 3: Difference Between Non-contrast and OPTISON Dose Level 1||21.64|2.02|0.0268
70964530|NCT03740997|141434341|OTHER||Mean Difference (Net)|16.1|STANDARD_DEVIATION|15.08|<|0.0001|TWO_SIDED|95.0|9.45|22.82|||Paired t-test|||Reader 3: Difference Between Non-contrast and OPTISON Dose Level 1||22.82|9.45|<0.0001
70964531|NCT03740997|141434341|OTHER||Mean Difference (Net)|12.1|STANDARD_DEVIATION|6.59||0.0028|TWO_SIDED|95.0|6.04|18.24|||Paired t-test|||Reader 3: Difference Between Non-contrast and OPTISON Dose Level 2||18.24|6.04|0.0028
70964532|NCT03740997|141434341|OTHER||Mean Difference (Net)|15.8|STANDARD_DEVIATION|13.37|<|0.0001|TWO_SIDED|95.0|10.04|21.61|||Paired t-test|||Reader 3: Difference Between Non-contrast and OPTISON Dose Level 2||21.61|10.04|<0.0001
70964533|NCT01026142|141434354|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0731|TWO_SIDED|95.0|0.65|1.02||The primary endpoint, IRF-assessed PFS, is tested at a two-sided 5% significance level.|Log Rank|Two-sided and stratified by: prior CNS disease present/absent, measurable disease at baseline, and response to trastuzumab in 1L metastatic setting.|The stratified Cox proportional hazard model will be used to estimate the HR between the two treatment arms and its 95% CI.|"The null hypothesis for the primary endpoint is that the survival distributions of IRF-assessed PFS in the two treatment groups are the same. The alternative hypothesis is that the survival distributions of IRF-assessed PFS in the treatment and the control arms are different:~H0: IRF PFS\<pertuzumab\> = IRF PFS\<control\> vs. H1: IRF PFS\<pertuzumab\> ≠ IRF PFS\<control\>"||1.02|0.65|0.0731
70964534|NCT01829425|141434363|NON_INFERIORITY|The study design will use a non-inferiority design to compare the primary outcome (change in UUI episodes in the hypnotherapy versus pharmacotherapy groups). With respect to the outcome variable of percent reduction in UUI episodes as determined by bladder diaries, we will use a one-sided non- inferiority test at level alpha = 0.25 and a non-inferiority margin of 5%.|Difference in median % change between gr|5.0|||<|0.025|ONE_SIDED|95.0|5.0||||Exact Mann Whitney|Due dispersion, medians were calculated. Exact Mann Whitney test was used for this analysis.|Hypnotherapy - Pharmacotherapy. % difference in median % change in UUI episodes with lower bounds \> - 5% would be consistent with non-inferiority||||5|<.025
70964535|NCT01829425|141434364|NON_INFERIORITY|The study design will use a non-inferiority design to compare the primary outcome (change in UUI episodes in the hypnotherapy versus pharmacotherapy groups). With respect to the outcome variable of percent reduction in UUI episodes as determined by bladder diaries, we will use a one-sided non- inferiority test at level alpha = 0.25 and a non-inferiority margin of 5%. If|Difference in median % change between gr|5.0|||<|0.025|ONE_SIDED|95.0|5.0||||Exact Mann Whitney||||||5|<.025
70964536|NCT04178967|141434375|SUPERIORITY||Risk Difference (RD)|21.9||||4e-06|TWO_SIDED|95.0|14.2|29.6|||Cochran-Mantel-Haenszel|||||29.6|14.2|0.000004
70964537|NCT04178967|141434376|SUPERIORITY||Risk Difference (RD)|33.3|||<|1e-06|TWO_SIDED|95.0|24.4|42.2|||Cochran-Mantel-Haenszel|||||42.2|24.4|<0.000001
70964538|NCT04178967|141434377|SUPERIORITY||Risk Difference (RD)|0.7||||0.308463|TWO_SIDED|95.0|-0.3|1.7|||Cochran-Mantel-Haenszel|||||1.7|-0.3|0.308463
70964539|NCT04178967|141434378|SUPERIORITY||Risk Difference (RD)|8.1||||0.001607|TWO_SIDED|95.0|4.1|12.0|||Cochran-Mantel-Haenszel|||||12.0|4.1|0.001607
70964540|NCT04178967|141434379|SUPERIORITY||Risk Difference (RD)|21.9||||4e-06|TWO_SIDED|95.0|14.2|29.6|||Cochran-Mantel-Haenszel|||||29.6|14.2|0.000004
70964541|NCT04178967|141434380|SUPERIORITY||Risk Difference (RD)|20.7||||8e-06|TWO_SIDED|95.0|13.3|28.1|||Cochran-Mantel-Haenszel|||||28.1|13.3|0.000008
70964542|NCT04178967|141434381|SUPERIORITY||LS Mean Difference (Final Values)|-27.53|||<|1e-06|TWO_SIDED|95.0|-34.9|-20.2|||ANCOVA|||||-20.2|-34.9|<0.000001
70964543|NCT04178967|141434382|SUPERIORITY||Risk Difference (RD)|28.3|||<|1e-06|TWO_SIDED|95.0|20.0|36.5|||Cochran-Mantel-Haenszel|||||36.5|20.0|<0.000001
70964544|NCT04178967|141434383|SUPERIORITY||Risk Difference (RD)|29.7|||<|1e-06|TWO_SIDED|95.0|21.0|38.4|||Cochran-Mantel-Haenszel|||||38.4|21.0|<0.000001
70964545|NCT04178967|141434384|SUPERIORITY||LS Mean Difference (Final Values)|-33.57|||<|1e-06|TWO_SIDED|95.0|-41.2|-26.0|||ANCOVA|||||-26.0|-41.2|<0.000001
70964546|NCT04178967|141434385|SUPERIORITY||LS Mean Difference (Final Values)|-16.2|||<|1e-06|TWO_SIDED|95.0|-20.3|-12.0|||Mixed Models Analysis|||||-12.0|-20.3|<0.000001
70964547|NCT04178967|141434386|SUPERIORITY||Risk Difference (RD)|4.9||||0.022921|TWO_SIDED|95.0|1.4|8.4|||Cochran-Mantel-Haenszel|||||8.4|1.4|0.022921
70964548|NCT04178967|141434387|SUPERIORITY||LS Mean Difference (Final Values)|-4.9|||<|1e-06|TWO_SIDED|95.0|-6.3|-3.5|||ANCOVA|||||-3.5|-6.3|<0.000001
70964549|NCT04178967|141434388|SUPERIORITY||Risk Difference (RD)|32.9||||1e-06|TWO_SIDED|95.0|22.2|43.6|||Cochran-Mantel-Haenszel|||||43.6|22.2|0.000001
70964550|NCT04178967|141434389|SUPERIORITY||Risk Difference (RD)|33.0||||1e-06|TWO_SIDED|95.0|22.2|43.8|||Cochran-Mantel-Haenszel|||||43.8|22.2|0.000001
70964551|NCT04178967|141434390|SUPERIORITY||LS Mean Difference (Final Values)|-37.09|||<|1e-06|TWO_SIDED|95.0|-47.4|-26.8|||ANCOVA|||||-26.8|-47.4|<0.000001
70964552|NCT04178967|141434391|SUPERIORITY||LS Mean Difference (Final Values)|-0.7|||<|1e-06|TWO_SIDED|95.0|-0.9|-0.5|||ANCOVA|||||-0.5|-0.9|<0.000001
70964553|NCT04178967|141434392|SUPERIORITY||Risk Difference (RD)|18.9||||0.000571|TWO_SIDED|95.0|9.6|28.1|||Cochran-Mantel-Haenszel|||||28.1|9.6|0.000571
70964554|NCT04178967|141434393|SUPERIORITY||Risk Difference (RD)|0.4||||0.469221|TWO_SIDED|95.0|-0.4|1.2|||Cochran-Mantel-Haenszel|||||1.2|-0.4|0.469221
70964555|NCT04178967|141434394|SUPERIORITY||Risk Difference (RD)|2.7||||0.113194|TWO_SIDED|95.0|-0.1|5.4|||Cochran-Mantel-Haenszel|||||5.4|-0.1|0.113194
70964556|NCT04178967|141434395|SUPERIORITY||Risk Difference (RD)|13.2||||0.00023|TWO_SIDED|95.0|7.7|18.7|||Cochran-Mantel-Haenszel|||||18.7|7.7|0.000230
70964557|NCT04178967|141434396|SUPERIORITY||Risk Difference (RD)|0.4||||0.46816|TWO_SIDED|95.0|-0.4|1.3|||Cochran-Mantel-Haenszel|||||1.3|-0.4|0.468160
70964558|NCT04178967|141434397|SUPERIORITY||Risk Difference (RD)|2.9||||0.11577|TWO_SIDED|95.0|-0.1|5.8|||Cochran-Mantel-Haenszel|||||5.8|-0.1|0.115770
70964559|NCT04178967|141434398|SUPERIORITY||Risk Difference (RD)|14.2||||0.000252|TWO_SIDED|95.0|8.2|20.1|||Cochran-Mantel-Haenszel|||||20.1|8.2|0.000252
70964560|NCT04178967|141434399|SUPERIORITY||LS Mean Difference (Final Values)|-30.76|||<|1e-06|TWO_SIDED|95.0|-36.93|-24.59|||ANCOVA|||||-24.59|-36.93|<0.000001
70964561|NCT04178967|141434401|SUPERIORITY||Risk Difference (RD)|12.8||||0.238245|TWO_SIDED|95.0|-9.5|35.1|||Cochran-Mantel-Haenszel|||||35.1|-9.5|0.238245
70964562|NCT04178967|141434401|SUPERIORITY||Risk Difference (RD)|4.8||||0.612427|TWO_SIDED|95.0|-17.8|27.3|||Cochran-Mantel-Haenszel|||||27.3|-17.8|0.612427
70964563|NCT04178967|141434402|SUPERIORITY||Risk Difference (RD)|32.6||||0.033876|TWO_SIDED|95.0|2.6|62.5|||Cochran-Mantel-Haenszel|||||62.5|2.6|0.033876
70964564|NCT04178967|141434402|SUPERIORITY||Risk Difference (RD)|13.4||||0.407417|TWO_SIDED|95.0|-17.5|44.3|||Cochran-Mantel-Haenszel|||||44.3|-17.5|0.407417
70964565|NCT04178967|141434403|SUPERIORITY||Risk Difference (RD)|20.3||||0.159281|TWO_SIDED|95.0|-11.4|52.0|||Cochran-Mantel-Haenszel|||||52.0|-11.4|0.159281
70964566|NCT04178967|141434403|SUPERIORITY||Risk Difference (RD)|20.4||||0.16495|TWO_SIDED|95.0|-10.6|51.4|||Cochran-Mantel-Haenszel|||||51.4|-10.6|0.164950
70964567|NCT04178967|141434404|SUPERIORITY||Risk Difference (RD)|19.7||||0.179704|TWO_SIDED|95.0|-12.2|51.2|||Cochran-Mantel-Haenszel|||||51.2|-12.2|0.179704
70964568|NCT04178967|141434404|SUPERIORITY||Risk Difference (RD)|24.3||||0.08308|TWO_SIDED|95.0|-6.5|55.1|||Cochran-Mantel-Haenszel|||||55.1|-6.5|0.083080
70964569|NCT04178967|141434405|SUPERIORITY||LS Mean Difference (Final Values)|-6.29||||0.176748|TWO_SIDED|95.0|-15.46|2.87|||ANCOVA|||||2.87|-15.46|0.176748
70964570|NCT04178967|141434405|SUPERIORITY||LS Mean Difference (Final Values)|-6.25||||0.183151|TWO_SIDED|95.0|-15.48|2.99|||ANCOVA|||||2.99|-15.48|0.183151
70964571|NCT04178967|141434406|SUPERIORITY||LS Mean Difference (Final Values)|0.1||||1e-06|TWO_SIDED|95.0|0.1|0.1|||ANCOVA|||UK||0.1|0.1|0.000001
70964572|NCT04178967|141434406|SUPERIORITY||LS Mean Difference (Final Values)|0.1||||1e-06|TWO_SIDED|95.0|0.0|0.1|||ANCOVA|||US||0.1|0.0|0.000001
70964573|NCT04178967|141434407|SUPERIORITY||LS Mean Difference (Final Values)|4.5||||0.005304|TWO_SIDED|95.0|1.3|7.6|||ANCOVA|||||7.6|1.3|0.005304
70964574|NCT04178967|141434408|SUPERIORITY||LS Mean Difference (Final Values)|-6.0|||<|1e-06|TWO_SIDED|95.0|-7.7|-4.3|||Mixed Models Analysis|||||-4.3|-7.7|<0.000001
70964575|NCT04178967|141434409|SUPERIORITY||LS Mean Difference (Final Values)|-2.91||||0.241275|TWO_SIDED|95.0|-7.85|2.03|||ANCOVA|||||2.03|-7.85|0.241275
70964576|NCT04178967|141434410|SUPERIORITY||LS Mean Difference (Final Values)|-2.74||||0.000116|TWO_SIDED|95.0|-4.12|-1.36|||ANCOVA|||||-1.36|-4.12|0.000116
70964577|NCT04178967|141434411|SUPERIORITY||LS Mean Difference (Final Values)|-1.1||||0.645132|TWO_SIDED|95.0|-5.86|3.67|||ANCOVA|||||3.67|-5.86|0.645132
70964578|NCT04178967|141434412|SUPERIORITY||LS Mean Difference (Final Values)|-2.75||||3.1e-05|TWO_SIDED|95.0|-4.03|-1.47|||ANCOVA|||||-1.47|-4.03|0.000031
70964579|NCT04178967|141434413|SUPERIORITY||LS Mean Difference (Final Values)|0.0||||0.974417|TWO_SIDED|95.0|-0.27|0.26|||ANCOVA|||||0.26|-0.27|0.974417
70964580|NCT04178967|141434414|SUPERIORITY||LS Mean Difference (Final Values)|-4.2||||0.084769|TWO_SIDED|95.0|-9.1|0.6|||Mixed Models Analysis|||||0.6|-9.1|0.084769
70964581|NCT00628251|141434415|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.6604|TWO_SIDED|95.0|0.51|1.56||If the observed p-value for the combined olaparib groups is \<0.02 (1-sided) then the result will be regarded as statistically significant.|Regression, Cox|Cox proportional hazards model with factors for treatment, BRCA (1 or 2) and platinum sensitivity (sensitive=1 or resistant/refractory=0).||Analysis of olaparib 200 or 400 mg bd (n=64) versus liposomal doxorubicin (n=33). A hazard ratio \< 1 favours olaparib.||1.56|0.51|0.6604
70964582|NCT00628251|141434415|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.7794||95.0|0.48|1.74||An observed p-value of \<0.005 (1-sided) will be regarded as statistically significant for a given pairwise comparison.|Regression, Cox|Cox proportional hazards model with factors for treatment, BRCA (1 or 2) and platinum sensitivity (sensitive=1 or resistant/refractory=0).||Analysis of olaparib 200 (n=32) versus liposomal doxorubicin (n=33). A hazard ratio \< 1 favours olaparib.||1.74|0.48|0.7794
70964583|NCT00628251|141434415|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.6604|TWO_SIDED|95.0|0.45|1.62||An observed p-value of \<0.005 (1-sided) will be regarded as statistically significant for a given pairwise comparison.|Regression, Cox|Cox proportional hazards model with factors for treatment, BRCA (1 or 2) and platinum sensitivity (sensitive=1 or resistant/refractory=0).||Analysis of olaparib 400 (n=32) versus liposomal doxorubicin (n=33). A hazard ratio \< 1 favours olaparib.||1.62|0.45|0.6604
70964584|NCT00628251|141434416|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.27||||0.1291|TWO_SIDED|95.0|0.79|7.32||2-sided p-value|Regression, Logistic|Analysis was performed using logistic regression with factors for treatment, BRCA status and platinum sensitivity.|An odds ratio \>1 favoured olaparib|Analysis of olaparib 200 or 400 (n=64) versus liposomal doxorubicin (n=33).||7.32|0.79|0.1291
70964585|NCT00628251|141434416|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.3131|TWO_SIDED|95.0|0.55|7.01||2-sided p-value|Regression, Logistic|Analysis was performed using logistic regression with factors for treatment, BRCA status and platinum sensitivity.|An odds ratio \>1 favoured olaparib.|Analysis of olaparib 200 (n=32) versus liposomal doxorubicin (n=33).||7.01|0.55|0.3131
70964586|NCT00628251|141434416|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.69||||0.1079|TWO_SIDED|95.0|0.81|9.76|||Regression, Logistic|The analysis was performed using logistic regression with factors for treatment, BRCA status and platinum sensitivity.|An odds ratio \>1 favoured olaparib|Analysis of olaparib 400 (n=32) versus liposomal doxorubicin (n=33).||9.76|0.81|0.1079
70964587|NCT00628251|141434422|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.5781|TWO_SIDED|95.0|0.41|1.7||2-sided p-value|Regression, Cox|Analysis was performed using a Cox proportional hazards model with factors for treatment, BRCA status and platinum sensitivity.|A hazard ratio of \<1 favoured olaparib.|Analysis of olaparib 200 or 400 (n=64) versus liposomal doxorubicin (n=33).||1.70|0.41|0.5781
70964588|NCT00628251|141434422|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.66||||0.3417|TWO_SIDED|95.0|0.27|1.55||2-sided p-value|Regression, Cox|Analysis was performed using a Cox proportional hazards model with factors for treatment, BRCA status and platinum sensitivity.|A hazard ratio of \<1 favoured olaparib.|Analysis of olaparib 200 (n=32) versus liposomal doxorubicin (n=33).||1.55|0.27|0.3417
70964589|NCT00628251|141434422|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.9877|TWO_SIDED|95.0|0.44|2.27||2-sided p-value|Regression, Cox|Analysis was performed using a Cox proportional hazards model with factors for treatment, BRCA status and platinum sensitivity.|A hazard ratio of \<1 favoured olaparib.|Analysis of olaparib 400 (n=32) versus liposomal doxorubicin (n=33).||2.27|0.44|0.9877
70964590|NCT03684642|141434453|NON_INFERIORITY|Non-inferiority of Efpeglenatide vs. Dulaglutide was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for the difference between groups was \<=0.3%.|Least Square (LS) Mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.2|0.14||||||A hierarchical step-down testing procedure was used to control type 1 error. Analysis was performed using ANCOVA model with the treatment groups, randomization strata, and geographical region as fixed classification effects, and baseline HbA1c value as a continuous covariate.||0.14|-0.20|
70964591|NCT03684642|141434453|NON_INFERIORITY|Non-inferiority of Efpeglenatide vs. Dulaglutide was demonstrated if the upper bound of the two-sided 95% CI for the difference between groups was \<=0.3%.|LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.25|0.09||||||A hierarchical step-down testing procedure was used to control type 1 error. Analysis was performed using ANCOVA model with the treatment groups, randomization strata, and geographical region as fixed classification effects, and baseline HbA1c value as a continuous covariate.||0.09|-0.25|
70964592|NCT03684642|141434453|SUPERIORITY|||||||0.7064||||||Threshold for significance at the level of 0.05.|ANCOVA|||||||0.7064
70964593|NCT03684642|141434453|SUPERIORITY|||||||0.3427||||||Threshold for significance at the level of 0.05.|ANCOVA|||||||0.3427
70964594|NCT04556396|141434466|SUPERIORITY||Odds Ratio (OR)|0.2|||<|0.01|TWO_SIDED|95.0|0.1|0.4|||Chi-squared|||||0.4|0.1|<0.01
70964595|NCT02374021|141434513|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.79|TWO_SIDED|95.0|-0.19|0.15|||ANCOVA|||||0.15|-0.19|0.79
70964596|NCT02374021|141434514|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.05|TWO_SIDED|95.0|-0.14|0.17|||ANCOVA|||||0.17|-0.14|0.05
70964597|NCT02374021|141434515|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.05|TWO_SIDED|95.0|-0.11|0.18|||ANCOVA|||||0.18|-0.11|0.05
70964598|NCT02374021|141434516|SUPERIORITY||Mean Difference (Final Values)|-0.003||||0.05|TWO_SIDED|95.0|-0.2|0.19|||ANCOVA|||||0.19|-0.20|0.05
70964599|NCT02374021|141434517|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.05|TWO_SIDED|95.0|-0.17|0.16|||ANCOVA|||||0.16|-0.17|0.05
70964600|NCT01667107|141434522|SUPERIORITY_OR_OTHER||Spearman rank correlation coefficient|0.53||||0.139|||||||Spearman rank correlation|||Spearman rank correlation between concurrent BAL and serum posaconazole concentrations||||0.139
70964601|NCT01667107|141434522|SUPERIORITY_OR_OTHER||Spearman rank correlation coefficient|0.59||||0.057|||||||Spearman rank correlation|||Spearman rank correlation between concurrent BAL and serum posaconazole concentrations||||0.057
70964602|NCT01162239|141434529|OTHER|||||||0.62|||||||Chi-squared|||||||0.62
70964603|NCT01162239|141434530|OTHER|||||||0.91|||||||Chi-squared|||||||0.91
70964604|NCT00228566|141434531|SUPERIORITY_OR_OTHER||% Responders = 201/241|83.4||||||95.0|78.7|88.1|||Descriptive Statistics||The Overall Endpoint includes the last postbaseline value for each patient in the full analysis set, regardless of evaluation period. The Number of Responders (at least minimal improvement) at this Overall Endpoint equaled a total of 201 patients.|This was an open label study, with all patients receiving treatment with armodafinil||88.1|78.7|
70964605|NCT01624259|141434555|NON_INFERIORITY_OR_EQUIVALENCE|"Family-wise Type I error rate was controlled by applying a serial gatekeeping strategy.~This calculation assumed a 0 difference in HbA1c between the 1.5 mg LY2189265 1.5-mg arm and 1.8 mg liraglutide, 0.4% margin of noninferiority, common Standard Deviation (SD) of 1.3% for change from baseline in HbA1c, 0.05 two-sided significance level, and 25% dropout rate at 26 weeks."|LS Mean Difference|-0.06|||<|0.001|TWO_SIDED|95.0|-0.19|0.07||1-sided raw p-value (no multiplicity adjustment).|Mixed Models Analysis|||To show noninferiority of 1.5 mg LY2189265 relative to 1.8 mg liraglutide with 90% power, 222 completers (444 total) at 26 weeks were required. Noninferiority of 1.5 mg LY2189265 relative to 1.8 mg liraglutide was demonstrated if the upper bound of the two-sided 95% Confidence Interval (CI) for the difference in mean change in HbA1c between the 1.5 mg LY2189265 arm and 1.8 mg liraglutide arm was below 0.4%.||0.07|-0.19|<0.001
70964606|NCT01624259|141434555|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06||||0.186|TWO_SIDED|95.0|-0.19|0.07||1-sided raw p-value (no multiplicity adjustment)|Mixed Models Analysis|||Superiority analysis||0.07|-0.19|0.186
70964607|NCT01624259|141434556|SUPERIORITY_OR_OTHER||LS Mean Difference|0.71|STANDARD_ERROR_OF_MEAN|0.28||0.01|TWO_SIDED|95.0|0.17|1.26||No adjustment for multiplicity.|ANCOVA|||Treatment comparison from ANCOVA model at 26 weeks.||1.26|0.17|0.010
70964608|NCT01624259|141434557|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.1||0.013|TWO_SIDED|95.0|0.05|0.45||No adjustment for multiplicity.|ANCOVA|||Treatment comparison from ANCOVA model.||0.45|0.05|0.013
70964609|NCT01624259|141434558|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|2.61||0.828|TWO_SIDED|95.0|-5.69|4.56||No adjustment for multiplicity.|ANCOVA|||Treatment comparison from ANCOVA model.||4.56|-5.69|0.828
70964610|NCT01624259|141434559|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.25|STANDARD_ERROR_OF_MEAN|1.86||0.228|TWO_SIDED|95.0|-5.91|1.41||No adjustment for multiplicity.|Mixed Models Analysis|P-value from pairwise comparison of LS means at 26 weeks from REML-based MMRM.||||1.41|-5.91|0.228
70964611|NCT01624259|141434560|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.322|TWO_SIDED|95.0|0.81|1.86||P-value of treatment comparison at Week 26 is from repeated generalized linear mixed model (GLM model).|Regression, Logistic|No adjustment for multiplicity.||Treatment comparison for HbA1c levels ≤6.5%||1.86|0.81|0.322
70964612|NCT01624259|141434560|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.925|TWO_SIDED|95.0|0.64|1.63||No adjustment for multiplicity.|Regression, Logistic|P-value of treatment comparison at Week 26 is from repeated generalized linear mixed model (GLM model).||Treatment comparison for HbA1c levels \<7.0%.||1.63|0.64|0.925
70964613|NCT01624259|141434561|SUPERIORITY_OR_OTHER||LS Mean Difference|1.43|STANDARD_ERROR_OF_MEAN|2.79||0.608|TWO_SIDED|95.0|-4.06|6.92|||ANCOVA|No adjustment for multiplicity.||||6.92|-4.06|0.608
70964614|NCT00232141|141434578|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.29||0.3914||95.0|-0.83|0.32||The analysis procedures planned will control the Type I error for the primary analysis. No multiplicity adjustment is needed for this two-group study.|ANCOVA|||Primary hypotheses : null (H0): µA=µP vs alternative (HA): µA≠µP (µA and µP represent true means for primary endpoint in active treatment \& placebo groups respectively). Assumptions in power calculation: 2-sided test with type I error at α =0.05, type II error at β =0.10, \& a common s.d of 2.2 for primary endpoint (based on previous clinical trial data). With n=150 subjects/ group (300 subjects overall) at least 90% power to detect a treatment difference of at least 1.1 in primary endpoint||0.32|-0.83|0.3914
70964615|NCT00232141|141434579|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.0131||95.0|-0.81|-0.1||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||-0.10|-0.81|0.0131
70964616|NCT00232141|141434579|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.24||0.0393||95.0|-0.96|-0.02||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||-0.02|-0.96|0.0393
70964617|NCT00232141|141434579|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.28||0.0554||95.0|-1.08|0.01||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 3||0.01|-1.08|0.0554
70964618|NCT00232141|141434579|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.29||0.1513||95.0|-0.99|0.15||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 4||0.15|-0.99|0.1513
70964619|NCT00232141|141434579|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.3||0.3345||95.0|-0.89|0.3||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 5||0.30|-0.89|0.3345
70964620|NCT00232141|141434579|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.31||0.0879||95.0|-1.13|0.08||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.08|-1.13|0.0879
70964621|NCT00232141|141434579|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.32||0.0307||95.0|-1.32|-0.07||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 7||-0.07|-1.32|0.0307
70964622|NCT00232141|141434579|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.31||0.0156||95.0|-1.36|-0.14||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 8||-0.14|-1.36|0.0156
70964623|NCT00232141|141434579|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.32||0.0981||95.0|-1.15|0.1||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 9||0.10|-1.15|0.0981
70964624|NCT00232141|141434579|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.31||0.306||95.0|-0.93|0.29||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.29|-0.93|0.3060
70964625|NCT00232141|141434579|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.33||0.1874||95.0|-1.08|0.21||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 11||0.21|-1.08|0.1874
70964626|NCT00232141|141434579|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.34||0.1025||95.0|-1.22|0.11||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 12||0.11|-1.22|0.1025
70964627|NCT00232141|141434579|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.34||0.0662||95.0|-1.3|0.04||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 13||0.04|-1.30|0.0662
70964628|NCT00232141|141434579|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.37||0.1856||95.0|-1.21|0.24||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.24|-1.21|0.1856
70964629|NCT00232141|141434579|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.3||0.7925||95.0|-0.66|0.5||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.50|-0.66|0.7925
70964630|NCT00232141|141434580|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.18||||0.1191||95.0|0.802|5.935||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 1||5.935|0.802|0.1191
70964631|NCT00232141|141434580|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.24||||0.5041||95.0|0.666|2.301||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 2||2.301|0.666|0.5041
70964632|NCT00232141|141434580|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.13||||0.6859||95.0|0.638|1.985||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 3||1.985|0.638|0.6859
70964633|NCT00232141|141434580|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.414||95.0|0.735|2.116||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 4||2.116|0.735|0.4140
70964634|NCT00232141|141434580|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.07||||0.7852||95.0|0.644|1.794||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 5||1.794|0.644|0.7852
70964635|NCT00232141|141434580|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09||||0.7399||95.0|0.654|1.817||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 6||1.817|0.654|0.7399
70964636|NCT00232141|141434580|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.57||||0.1055||95.0|0.913|2.701||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 7||2.701|0.913|0.1055
70964637|NCT00232141|141434580|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.41||||0.2107||95.0|0.829|2.401||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 8||2.401|0.829|0.2107
70964638|NCT00232141|141434580|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.19||||0.527||95.0|0.697|2.046||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 9||2.046|0.697|0.5270
70964639|NCT00232141|141434580|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.89||||0.6845||95.0|0.513|1.546||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 10||1.546|0.513|0.6845
70964640|NCT00232141|141434580|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.92||||0.7737||95.0|0.522|1.619||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 11||1.619|0.522|0.7737
70964641|NCT00232141|141434580|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||0.8853||95.0|0.597|1.818||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 12||1.818|0.597|0.8853
70964642|NCT00232141|141434580|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09||||0.7712||95.0|0.612|1.946||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 13||1.946|0.612|0.7712
70964643|NCT00232141|141434580|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.02||||0.9586||95.0|0.574|1.796||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 14||1.796|0.574|0.9586
70964644|NCT00232141|141434580|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.79||||0.3482||95.0|0.486|1.283||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Endpoint-BOCF||1.283|0.486|0.3482
70964645|NCT00232141|141434581|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.62||||0.1132||95.0|0.882|2.969||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 1||2.969|0.882|0.1132
70964646|NCT00232141|141434581|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.2||||0.4687||95.0|0.731|1.978||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 2||1.978|0.731|0.4687
70964647|NCT00232141|141434581|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.44||||0.1546||95.0|0.877|2.375||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 3||2.375|0.877|0.1546
70964648|NCT00232141|141434581|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.23||||0.4216||95.0|0.7444|2.025||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 4||2.025|0.7444|0.4216
70964649|NCT00232141|141434581|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.92||||0.7479||95.0|0.556|1.527||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 5||1.527|0.556|0.7479
70964650|NCT00232141|141434581|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.8||||0.3842||95.0|0.481|1.33||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 6||1.330|0.481|0.3842
70964651|NCT00232141|141434581|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||0.845||95.0|0.627|1.769||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 7||1.769|0.627|0.8450
70964652|NCT00232141|141434581|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.48||||0.1602||95.0|0.864|2.527||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 8||2.527|0.864|0.1602
70964653|NCT00232141|141434581|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.6815||95.0|0.66|1.89||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 9||1.890|0.660|0.6815
70964654|NCT00232141|141434581|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.85||||0.5635||95.0|0.486|1.482||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 10||1.482|0.486|0.5635
70964655|NCT00232141|141434581|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.21||||0.49||95.0|0.699|2.104||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 11||2.104|0.699|0.4900
70964656|NCT00232141|141434581|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.48||||0.1602||95.0|0.856|2.575||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 12||2.575|0.856|0.1602
70964657|NCT00232141|141434581|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17||||0.5819||95.0|0.663|2.079||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 13||2.079|0.663|0.5819
70964658|NCT00232141|141434581|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.2796||95.0|0.768|2.432||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 14||2.432|0.768|0.2796
70903716|NCT02307513|141296143|SUPERIORITY||Hazard Ratio (HR)|2.4|||<|0.0001|TWO_SIDED|95.0|1.692|3.405|||Stratified Log-Rank Test|Treatment comparison is based on the stratified log-rank test, with sex and region as the stratification factors.|The HR is based on the stratified Cox model with baseline number of oral ulcers and sex and region as the stratification factors.|||3.405|1.692|<0.0001
70903717|NCT02307513|141296144|SUPERIORITY||Adjusted difference in percentages|30.6|||<|0.0001|TWO_SIDED|95.0|18.1|43.1|||Cochran-Mantel-Haenszel|2 sided p-value based on the CMH test adjusting for sex and region.|Adjusted difference was the weighted average of the treatment differences across the 4 strata of combined sex and region factors with the CMH weights.|||43.1|18.1|<0.0001
70903718|NCT02307513|141296145|SUPERIORITY||Difference in LS Mean|-3.0||||0.0003|TWO_SIDED|95.0|-4.5|-1.4|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.||||-1.4|-4.5|0.0003
70903719|NCT02307513|141296146|SUPERIORITY||Adjusted difference in percentages|28.4||||0.11|TWO_SIDED|95.0|-3.6|60.4|||Cochran-Mantel-Haenszel|2 sided p-value based on the CMH test adjusting for sex.|Adjusted difference was the weighted average of the treatment differences across the 2 strata of sex with the CMH weights.|||60.4|-3.6|0.1100
70903720|NCT02307513|141296147|SUPERIORITY||Adjusted difference in percentages|17.5||||0.0204|TWO_SIDED|95.0|4.2|30.7|||Cochran-Mantel-Haenszel|Two-sided p-value was based on the CMH test, adjusting for sex and region.|Adjusted difference was the weighted average of the treatment differences across the 4 strata of combined sex and region factors with the CMH weights.|||30.7|4.2|0.0204
70903721|NCT02307513|141296148|SUPERIORITY||Hazard Ratio (HR)|0.611||||0.0112|TWO_SIDED|95.0|0.408|0.915|||Stratified Log Rank Test|Treatment comparison is based on the stratified log-rank test, with sex and region as the stratification factors.|The HR is based on the stratified Cox model with baseline number of oral ulcers and sex and region as the stratification factors|||0.915|0.408|0.0112
70903722|NCT02307513|141296149|SUPERIORITY||Difference in LS Means|-0.4||||0.0683|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|ANCOVA model with treatment group, sex and region as factors and the baseline ulcers number as a covariate.||||0.0|-0.9|0.0683
70903723|NCT02307513|141296150|SUPERIORITY||Difference in LS Mean|-0.1||||0.5944|TWO_SIDED|95.0|-0.4|0.3|||ANCOVA|Based on an ANCOVA model for the change from baseline, with treatment arm, sex and region as factors and the baseline score as a covariate.||||0.3|-0.4|0.5944
70903724|NCT02307513|141296151|SUPERIORITY||Difference in LS Mean|-5.5||||0.6182|TWO_SIDED|95.0|-27.6|16.7|||ANCOVA|Based on an ANCOVA model for the change from baseline, with treatment arm, sex and region as factors and the baseline score as a covariate.||||16.7|-27.6|0.6182
70903725|NCT05952297|141296167|SUPERIORITY|||||||0.88|||||||mixed model|linear mixed model, time x condition effect||||||.88
70903726|NCT03107377|141296170|SUPERIORITY||Risk Difference (RD)|-4.81||||0.0256|TWO_SIDED|95.0|-9.02|-0.61|||Chi-squared|||||-0.61|-9.02|0.0256
70903727|NCT03107377|141296171|SUPERIORITY||Risk Difference (RD)|-2.53||||0.0316|TWO_SIDED|95.0|-4.84|-0.23|||Chi-squared|||||-0.23|-4.84|0.0316
70903728|NCT03107377|141296175|SUPERIORITY|||||||1|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with =0% adherence||||1.0000
70903729|NCT03107377|141296175|SUPERIORITY|||||||1|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>0% adherence||||1.0000
70903730|NCT03107377|141296175|SUPERIORITY|||||||0.6278|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>=20% adherence||||.6278
70903731|NCT03107377|141296175|SUPERIORITY|||||||0.6404|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>=40% adherence||||.6404
70903732|NCT03107377|141296175|SUPERIORITY|||||||0.5008|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>=60% adherence||||.5008
70903733|NCT03107377|141296175|SUPERIORITY|||||||0.1818|||||||Chi-squared|||A comparison of infection rates between the treatment arms amongst subjects with \>=80% adherence||||.1818
70903734|NCT03107377|141296175|SUPERIORITY|||||||0.0012|||||||Chi-squared|||A comparison of infection rates between the treatment arms amongst subjects with =100% adherence||||0.0012
70903735|NCT03107377|141296176|SUPERIORITY|||||||1|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with =0% adherence||||1.0000
70903736|NCT03107377|141296176|SUPERIORITY|||||||0.4375|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>0% adherence||||0.4375
70903737|NCT03107377|141296176|SUPERIORITY|||||||0.4444|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>=20% adherence||||0.4444
70903738|NCT03107377|141296176|SUPERIORITY|||||||0.1836|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>=60% adherence||||0.1836
70903739|NCT03107377|141296176|SUPERIORITY|||||||0.5006|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>=80% adherence||||0.5006
70903740|NCT03107377|141296176|SUPERIORITY|||||||1|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with =100% adherence||||1.000
70903741|NCT02583763|141296185|SUPERIORITY||||||>|0.05||||||Significance value stated as p\<0.05|t-test, 2 sided|||Paired sample T test were used to analyse normally distributed data.||||>0.05
70903742|NCT02583763|141296186|SUPERIORITY||||||>|0.05||||||Significance value was stated as p\<0.05|t-test, 2 sided|||||||>0.05
70903743|NCT02583763|141296187|SUPERIORITY|||||||0.003||||||Significance value was set to p\<0.05|t-test, 2 sided|||||||0.003
70903744|NCT05408468|141296219|SUPERIORITY||Mean Difference (Net)|-5.595|STANDARD_ERROR_OF_MEAN|1.731||0.387|TWO_SIDED||||||Mixed Models Analysis||Baseline 1.731 One week 1.894|||||0.387
70903745|NCT05408468|141296219|SUPERIORITY||Mean Difference (Net)|-3.782|STANDARD_ERROR_OF_MEAN|2.048||0.387|TWO_SIDED||||||Mixed Models Analysis||Baseline 2.048 One week 2.122|||||0.387
70903746|NCT05408468|141296220|SUPERIORITY||Mean Difference (Net)|-4.5|STANDARD_ERROR_OF_MEAN|1.693||0.062|TWO_SIDED||||||Mixed Models Analysis||Baseline 1.693 One week 1.840|||||0.062
70903747|NCT05408468|141296220|SUPERIORITY||Mean Difference (Net)|-0.764|STANDARD_ERROR_OF_MEAN|2.003||0.062|TWO_SIDED||||||Mixed Models Analysis||Baseline 2.003 One week 2.069|||||0.062
70903748|NCT05408468|141296222|SUPERIORITY||Median Difference (Final Values)|2.58|STANDARD_ERROR_OF_MEAN|2.84||0.369|TWO_SIDED||||||t-test, 2 sided|||||||0.369
70964659|NCT00232141|141434581|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.86||||0.5437||95.0|0.534|1.39||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Endpoint-BOCF||1.390|0.534|0.5437
70964660|NCT00232141|141434582|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.54|STANDARD_ERROR_OF_MEAN|2.53||0.5425||95.0|-3.44|6.52||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Disturbance.||6.52|-3.44|0.5425
70964661|NCT00232141|141434582|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.25||0.3184||95.0|-0.75|0.25||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Quantity||0.25|-0.75|0.3184
70964662|NCT00232141|141434582|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|2.92||0.9886||95.0|-5.81|5.72||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Adequacy||5.72|-5.81|0.9886
70964663|NCT00232141|141434582|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.41|STANDARD_ERROR_OF_MEAN|2.51||0.5742||95.0|-3.53|6.35||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Awaken Short of Breath or with Headache||6.35|-3.53|0.5742
70964664|NCT00232141|141434582|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|2.5||0.5775||95.0|-3.54|6.33||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Somnolence||6.33|-3.54|0.5775
70964665|NCT00232141|141434582|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.34|STANDARD_ERROR_OF_MEAN|3.21||0.004||95.0|3.02|15.66||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Snoring||15.66|3.02|0.0040
70964666|NCT00232141|141434582|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.07|STANDARD_ERROR_OF_MEAN|1.98||0.5882||95.0|-2.83|4.97||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Sleep Problems Index I||4.97|-2.83|0.5882
70964667|NCT00232141|141434582|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.42|STANDARD_ERROR_OF_MEAN|1.89||0.4516||95.0|-2.3|5.14||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Sleep Problems Index II||5.14|-2.30|0.4516
70964668|NCT00232141|141434583|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.39||0.5105||95.0|-0.51|1.03||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Anxiety||1.03|-0.51|0.5105
70964669|NCT00232141|141434583|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.37||0.2513||95.0|-0.3|1.14||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Depression||1.14|-0.30|0.2513
70964670|NCT00232141|141434584|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.27||0.5834||95.0|-0.38|0.67||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Pain Severity Index||0.67|-0.38|0.5834
70964671|NCT00232141|141434584|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.25||0.7783||95.0|-0.43|0.57||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Pain Interference Index||0.57|-0.43|0.7783
70964672|NCT00232141|141434585|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.27||0.4776||95.0|-0.73|0.34||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||||0.34|-0.73|0.4776
70964673|NCT00232141|141434586|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0077||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||||||0.0077
70964674|NCT00232141|141434587|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3852||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||||||0.3852
70964675|NCT00232141|141434588|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3097||95.0|-0.03|0.1||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Burning||0.10|-0.03|0.3097
70964676|NCT00232141|141434588|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.6147||95.0|-0.07|0.04||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Pressing||0.04|-0.07|0.6147
70964677|NCT00232141|141434588|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.6838||95.0|-0.05|0.07||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Paroxysmal||0.07|-0.05|0.6838
70964678|NCT00232141|141434588|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.6479||95.0|-0.07|0.04||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Evoked||0.04|-0.07|0.6479
70964679|NCT00232141|141434588|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.03||0.1849||95.0|-0.02|0.11||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Paresthesia/dysesthesia||0.11|-0.02|0.1849
70964680|NCT00232141|141434588|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.5898||95.0|0.0|0.0||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Total Score||0|0|0.5898
70964681|NCT00232141|141434589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.29||0.6865||95.0|-0.45|0.68||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Static mechanical allodynia||0.68|-0.45|0.6865
70964682|NCT00232141|141434589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.25||0.3787||95.0|-0.71|0.27||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Dynamic mechanical allodynia||0.27|-0.71|0.3787
70964683|NCT00232141|141434589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.35||0.7704||95.0|-0.79|0.59||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Punctate hyperalgesia testing area||0.59|-0.79|0.7704
70964684|NCT00232141|141434589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.33||0.6088||95.0|-0.82|0.48||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Temporal summation to tactile stimuli||0.48|-0.82|0.6088
70964685|NCT00232141|141434589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.33||0.3767||95.0|-0.93|0.35||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Cold allodynia testing area||0.35|-0.93|0.3767
70964686|NCT00232141|141434589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.38||0.7689||95.0|-0.64|0.86||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Cold hyperalgesia testing area||0.86|-0.64|0.7689
70964687|NCT00232141|141434590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.25||0.1277||95.0|-0.86|0.11||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||||0.11|-0.86|0.1277
70964688|NCT00232141|141434591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.18||0.0469||95.0|-0.71|0.0||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||-0.00|-0.71|0.0469
70964689|NCT00232141|141434591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.23||0.0067||95.0|-1.08|-0.18||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||-0.18|-1.08|0.0067
70964690|NCT00232141|141434591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.27||0.031||95.0|-1.1|-0.05||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 3||-0.05|-1.10|0.0310
70964691|NCT00232141|141434591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.27||0.2088||95.0|-0.86|0.19||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 4||0.19|-0.86|0.2088
70964692|NCT00232141|141434591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.26||0.1849||95.0|-0.87|0.17||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 5||0.17|-0.87|0.1849
70964693|NCT00232141|141434591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.27||0.0452||95.0|-1.09|-0.01||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||-0.01|-1.09|0.0452
70964694|NCT00232141|141434591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.29||0.0359||95.0|-1.18|-0.04||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 7||-0.04|-1.18|0.0359
70964695|NCT00232141|141434591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.29||0.0184||95.0|-1.26|-0.12||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 8||-0.12|-1.26|0.0184
70964696|NCT00232141|141434591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.29||0.1043||95.0|-1.06|0.1||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 9||0.10|-1.06|0.1043
70964697|NCT00232141|141434591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.29||0.1053||95.0|-1.04|0.1||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.10|-1.04|0.1053
70964698|NCT00232141|141434591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.3||0.144||95.0|-1.03|0.15||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 11||0.15|-1.03|0.1440
70964699|NCT00232141|141434591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.32||0.0866||95.0|-1.17|0.08||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 12||0.08|-1.17|0.0866
70964700|NCT00232141|141434591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.32||0.0359||95.0|-1.3|-0.04||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 13||-0.04|-1.30|0.0359
70964701|NCT00232141|141434591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.34||0.0711||95.0|-1.3|0.05||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.05|-1.30|0.0711
70964702|NCT00232141|141434593|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.23||0.0685||95.0|-0.89|0.03||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.03|-0.89|0.0685
70964703|NCT00232141|141434593|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.28||0.928||95.0|-0.52|0.57||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.57|-0.52|0.9280
70964704|NCT00232141|141434593|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.29||0.6672||95.0|-0.71|0.45||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.45|-0.71|0.6672
70964705|NCT00232141|141434593|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.29||0.9731||95.0|-0.57|0.59||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.59|-0.57|0.9731
70964706|NCT00232141|141434593|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.33||0.9045||95.0|-0.61|0.69||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.69|-0.61|0.9045
70964707|NCT00232141|141434593|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.3||0.8298||95.0|-0.53|0.66||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.66|-0.53|0.8298
70964708|NCT00232141|141434594|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.24||0.8605||95.0|-0.52|0.44||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.44|-0.52|0.8605
70964709|NCT00232141|141434594|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.27||0.8348||95.0|-0.58|0.47||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.47|-0.58|0.8348
70964710|NCT00232141|141434594|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.26||0.2227||95.0|-0.83|0.19||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.19|-0.83|0.2227
70964711|NCT00232141|141434594|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.27||0.4753||95.0|-0.73|0.34||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.34|-0.73|0.4753
70964712|NCT00232141|141434594|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.27||0.6017||95.0|-0.4|0.68||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.68|-0.40|0.6017
70964713|NCT00232141|141434594|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.26||0.6158||95.0|-0.38|0.64||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.64|-0.38|0.6158
70964714|NCT00232141|141434595|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.22||0.239||95.0|-0.69|0.17||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.17|-0.69|0.2390
70964715|NCT00232141|141434595|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.24||0.9444||95.0|-0.49|0.45||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.45|-0.49|0.9444
70964716|NCT00232141|141434595|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.27||0.7386||95.0|-0.63|0.45||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.45|-0.63|0.7386
70964717|NCT00232141|141434595|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.27||0.3493||95.0|-0.79|0.28||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.28|-0.79|0.3493
70964718|NCT00232141|141434595|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.3||0.6596||95.0|-0.46|0.73||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.73|-0.46|0.6596
70964719|NCT00232141|141434595|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.27||0.4075||95.0|-0.31|0.77||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.77|-0.31|0.4075
70964720|NCT00232141|141434596|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.23||0.0202||95.0|-1.01|-0.09||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||-0.09|-1.01|0.0202
70964721|NCT00232141|141434596|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.26||0.8865||95.0|-0.55|0.47||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.47|-0.55|0.8865
70964722|NCT00232141|141434596|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.27||0.9964||95.0|-0.54|0.54||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.54|-0.54|0.9964
70964723|NCT00232141|141434596|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.28||0.5993||95.0|-0.7|0.41||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.41|-0.70|0.5993
70964724|NCT00232141|141434596|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.31||0.3553||95.0|-0.33|0.9||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.90|-0.33|0.3553
70964725|NCT00232141|141434596|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.29||0.2771||95.0|-0.25|0.88||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.88|-0.25|0.2771
70964726|NCT00232141|141434597|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.26||0.2352||95.0|-0.82|0.2||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.20|-0.82|0.2352
70964727|NCT00232141|141434597|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.26||0.7607||95.0|-0.6|0.44||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.44|-0.60|0.7607
70964728|NCT00232141|141434597|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.27||0.6563||95.0|-0.64|0.4||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.40|-0.64|0.6563
70964729|NCT00232141|141434597|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.27||0.8319||95.0|-0.58|0.47||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.47|-0.58|0.8319
70903749|NCT05408468|141296223|SUPERIORITY||Median Difference (Final Values)|2.59|STANDARD_ERROR_OF_MEAN|3.79||0.498|TWO_SIDED||||||t-test, 2 sided|||||||0.498
70903750|NCT00405639|141296250|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
70903751|NCT00405639|141296251|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
70903752|NCT00405639|141296252|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||t-test, 2 sided|||||||0.07
70903753|NCT00405639|141296253|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
70903754|NCT01483937|141296254|SUPERIORITY_OR_OTHER|||||||0.533||95.0|||||ANOVA|||||||.533
70903755|NCT04534114|141296287|OTHER|Fesomersen groups were compared to the placebo group using two-sided log-rank tests. Due to the exploratory nature of these analyses, no multiplicity adjustment was done. Cause-specific hazard ratio and corresponding 2-sided 95% confidence intervals, comparing the hazards for the event-of-interest in each of the Fesomersen groups with the placebo group were estimated based on three separate cause-specific Cox proportional hazards models as exploratory analysis.|Cause specific Hazard ratio|0.94||||0.944|TWO_SIDED|95.0|0.19|4.68|||Log Rank|||||4.68|0.19|0.944
70903756|NCT04534114|141296287|OTHER|Fesomersen groups were compared to the placebo group using two-sided log-rank tests. Due to the exploratory nature of these analyses, no multiplicity adjustment was done. Cause-specific hazard ratio and corresponding 2-sided 95% confidence intervals, comparing the hazards for the event-of-interest in each of the Fesomersen groups with the placebo group were estimated based on three separate cause-specific Cox proportional hazards models as exploratory analysis.|Cause specific Hazard ratio|0.95||||0.953|TWO_SIDED|95.0|0.19|4.72|||Log Rank|||||4.72|0.19|0.953
70903757|NCT04534114|141296287|OTHER|Fesomersen groups were compared to the placebo group using two-sided log-rank tests. Due to the exploratory nature of these analyses, no multiplicity adjustment was done. Cause-specific hazard ratio and corresponding 2-sided 95% confidence intervals, comparing the hazards for the event-of-interest in each of the Fesomersen groups with the placebo group were estimated based on three separate cause-specific Cox proportional hazards models as exploratory analysis.|Cause specific Hazard ratio|0.63||||0.605|TWO_SIDED|95.0|0.1|3.75|||Log Rank|||||3.75|0.10|0.605
70903758|NCT04534114|141296288|OTHER|Fesomersen groups were compared to the placebo group using two-sided log-rank tests. Due to the exploratory nature of these analyses, no multiplicity adjustment was done. Cause-specific hazard ratio and corresponding 2-sided 95% confidence intervals, comparing the hazards for the event-of-interest in each of the Fesomersen groups with the placebo group were estimated based on three separate cause-specific Cox proportional hazards models as exploratory analysis.|Cause specific Hazard ratio|1.45||||0.612|TWO_SIDED|95.0|0.34|6.08|||Log Rank|||||6.08|0.34|0.612
70903759|NCT04534114|141296288|OTHER|Fesomersen groups were compared to the placebo group using two-sided log-rank tests. Due to the exploratory nature of these analyses, no multiplicity adjustment was done. Cause-specific hazard ratio and corresponding 2-sided 95% confidence intervals, comparing the hazards for the event-of-interest in each of the Fesomersen groups with the placebo group were estimated based on three separate cause-specific Cox proportional hazards models as exploratory analysis.|Cause specific Hazard ratio|1.27||||0.757|TWO_SIDED|95.0|0.28|5.66|||Log Rank|||||5.66|0.28|0.757
70964730|NCT00232141|141434597|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3086||95.0|-0.28|0.89||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.89|-0.28|0.3086
70964731|NCT00232141|141434597|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.28||0.7972||95.0|-0.48|0.62||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.62|-0.48|0.7972
70964732|NCT00232141|141434598|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.28||0.1863||95.0|-0.94|0.18||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.18|-0.94|0.1863
70964733|NCT00232141|141434598|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|-0.31||0.5953||95.0|-0.77|0.44||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.44|-0.77|0.5953
70964734|NCT00232141|141434598|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.28||0.508||95.0|-0.73|0.36||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.36|-0.73|0.5080
70964735|NCT00232141|141434598|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.28||0.5842||95.0|-0.7|0.39||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.39|-0.70|0.5842
70964736|NCT00232141|141434598|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.3||0.4286||95.0|-0.35|0.83||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.83|-0.35|0.4286
70964737|NCT00232141|141434598|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.28||0.5766||95.0|-0.4|0.71||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.71|-0.40|0.5766
70964738|NCT00232141|141434599|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.28||0.5493||95.0|-0.73|0.39||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.39|-0.73|0.5493
70964739|NCT00232141|141434599|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9875||95.0|-0.58|0.59||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.59|-0.58|0.9875
70964740|NCT00232141|141434599|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.29||0.6931||95.0|-0.68|0.45||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.45|-0.68|0.6931
70964741|NCT00232141|141434599|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.28||0.4614||95.0|-0.34|0.75||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.75|-0.34|0.4614
70964742|NCT00232141|141434599|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.31||0.1467||95.0|-0.16|1.06||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||1.06|-0.16|0.1467
70964743|NCT00232141|141434599|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.29||0.2819||95.0|-0.25|0.87||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.87|-0.25|0.2819
70964744|NCT00232141|141434600|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.26||0.8727||95.0|-0.55|0.46||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.46|-0.55|0.8727
70964745|NCT00232141|141434600|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.28||0.6897||95.0|-0.65|0.43||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.43|-0.65|0.6897
70964746|NCT00232141|141434600|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.26||0.7527||95.0|-0.6|0.44||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.44|-0.60|0.7527
70964747|NCT00232141|141434600|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.28||0.6394||95.0|-0.67|0.41||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.41|-0.67|0.6394
70964748|NCT00232141|141434600|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.31||0.1188||95.0|-0.13|1.11||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||1.11|-0.13|0.1188
70964749|NCT00232141|141434600|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.28||0.2685||95.0|-0.24|0.87||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.87|-0.24|0.2685
70964750|NCT00232141|141434601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.28||0.4991||95.0|-0.74|0.36||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.36|-0.74|0.4991
70964751|NCT00232141|141434601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.3||0.6094||95.0|-0.73|0.43||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.43|-0.73|0.6094
70964752|NCT00232141|141434601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.26||0.3669||95.0|-0.76|0.28||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.28|-0.76|0.3669
70964753|NCT00232141|141434601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.26||0.7641||95.0|-0.43|0.59||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.59|-0.43|0.7641
70964754|NCT00232141|141434601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.27||0.9428||95.0|-0.51|0.55||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.55|-0.51|0.9428
70964755|NCT00232141|141434601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.26||0.9508||95.0|-0.52|0.49||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.49|-0.52|0.9508
70964756|NCT00232141|141434602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.25||0.0073||95.0|-1.18|-0.19||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||-0.19|-1.18|0.0073
70964757|NCT00232141|141434602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.3||0.2202||95.0|-0.96|0.22||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.22|-0.96|0.2202
70964758|NCT00232141|141434602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.29||0.1824||95.0|-0.95|0.18||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.18|-0.95|0.1824
70964759|NCT00232141|141434602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.3||0.1872||95.0|-0.98|0.19||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.19|-0.98|0.1872
70964760|NCT00232141|141434602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.32||0.4374||95.0|-0.38|0.88||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.88|-0.38|0.4374
70964761|NCT00232141|141434602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.3||0.4406||95.0|-0.36|0.82||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.82|-0.36|0.4406
70964762|NCT00232141|141434603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.27||0.2277||95.0|-0.86|0.21||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.21|-0.86|0.2277
70964763|NCT00232141|141434603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.33||0.8407||95.0|-0.71|0.58||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.58|-0.71|0.8407
70964764|NCT00232141|141434603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.29||0.8809||95.0|-0.62|0.53||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.53|-0.62|0.8809
70964765|NCT00232141|141434603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.29||0.6288||95.0|-0.72|0.43||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.43|-0.72|0.6288
70964766|NCT00232141|141434603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.3||0.9739||95.0|-0.59|0.61||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.61|-0.59|0.9739
70964767|NCT00232141|141434603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.29||0.8926||95.0|-0.61|0.53||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.53|-0.61|0.8926
70964768|NCT00232141|141434606|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7136||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||||||0.7136
70964769|NCT00232141|141434607|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6729||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||||||0.6729
70964770|NCT01920594|141434645|SUPERIORITY||Mean Difference (Final Values)|2228.14||||0.082|TWO_SIDED|95.0|-292.84|4749.11|||ANCOVA||The point estimate was calculated as least square (LS) mean difference (final values) of S-100B Protein \[test\] and S-100B Protein \[reference\].|||4749.11|-292.84|0.0820
70964771|NCT01920594|141434646|SUPERIORITY||Mean Difference (Final Values)|777.95||||0.1997|TWO_SIDED|95.0|-424.04|1979.94|||ANCOVA||The point estimate was calculated as LS mean difference (final values) of GFAP \[test\] and GFAP \[reference\].|||1979.94|-424.04|0.1997
70964772|NCT01920594|141434652|SUPERIORITY||Estimate of comparison (Ratio)|1.77||||0.153|TWO_SIDED|95.0|0.8|3.9|||ANOVA||The point estimate was calculated as Geometric mean ratio of S-100B\[test\] and S-100B\[reference\].|||3.90|0.80|0.1530
70964773|NCT01920594|141434653|SUPERIORITY||Estimate of comparison (Ratio)|3.13||||0.1377|TWO_SIDED|95.0|0.69|14.26|||ANOVA||The point estimate was calculated as Geometric mean ratio of GFAP\[test\] and GFAP\[reference\].|||14.26|0.69|0.1377
70964774|NCT01920594|141434654|SUPERIORITY||Mean Difference (Final Values)|34.56|||<|0.0001|TWO_SIDED|95.0|21.95|47.17|||ANCOVA||The point estimate was calculated as LS mean difference final values of Erythropoietin\[test\] and Erythropoietin\[reference\].|||47.17|21.95|<.0001
70964775|NCT01920594|141434655|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.2404|TWO_SIDED|95.0|-0.37|1.45|||ANCOVA||The point estimate was calculated as LS mean difference final values of Lactate Dehydrogenase\[test\] and Lactate Dehydrogenase\[reference\].|||1.45|-0.37|0.2404
70964776|NCT01920594|141434656|SUPERIORITY||Mean Difference (Final Values)|925.88||||0.0526|TWO_SIDED|95.0|-10.73|1862.49|||ANCOVA||The point estimate was calculated as LS mean difference final values of Tau Protein\[test\] and Tau Protein\[reference\].|||1862.49|-10.73|0.0526
70964777|NCT01920594|141434657|SUPERIORITY||Mean Difference (Final Values)|4.11||||0.0893|TWO_SIDED|95.0|-0.65|8.87|||ANCOVA||The point estimate was calculated as LS mean difference final values of Neuron Specific Enolase\[test\] and Neuron Specific Enolase\[reference\].|||8.87|-0.65|0.0893
70964778|NCT01920594|141434662|SUPERIORITY||Ratio of geometric mean|1.84||||0.5012|TWO_SIDED|95.0|0.3|11.32|||ANOVA|||For Troponin I||11.32|0.30|0.5012
70964779|NCT01920594|141434662|SUPERIORITY||Ratio of geometric mean|0.75||||0.8053|TWO_SIDED|95.0|0.07|8.57|||ANOVA|||For Troponin T||8.57|0.07|0.8053
70964780|NCT02039726|141434674|OTHER||Hazard Ratio (HR)|0.758||||0.0185|TWO_SIDED|95.0|0.584|0.983|||P-value for HR=1 (1-sided)|||Stratified analysis - stratification factors include prior therapy and response (Relapsed in ≤6 months (not post-HSCT), Refractory, or relapsed in ≤6 months post allogeneic HSCT), and pre-selected chemotherapy (High intensity chemotherapy \[MEC or FLAG-IDA\], or low intensity chemotherapy \[LoDAC\]).||0.983|0.584|0.0185
70964781|NCT02039726|141434675|OTHER||Hazard Ratio (HR)|0.898||||0.2034|TWO_SIDED|95.0|0.697|1.157|||P value for HR=1 (1-sided)|||Stratified analysis - stratification factors include prior therapy and response (Relapsed in ≤6 months (not post-HSCT), Refractory, or relapsed in ≤6 months post allogeneic HSCT), and pre-selected chemotherapy (High intensity chemotherapy \[MEC or FLAG-IDA\], or low intensity chemotherapy \[LoDAC\]).||1.157|0.697|0.2034
70964782|NCT00813319|141434687|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||This comparison is for participants in the Girls OnGuard/HPV Awareness condition compared to the General Health Promotion condition||||>.05
70964783|NCT00813319|141434688|SUPERIORITY_OR_OTHER||||||=|0.52|||||||Chi-squared|||||||=.52
70964784|NCT00813319|141434689|SUPERIORITY_OR_OTHER||||||=|0.12|||||||Chi-squared|Degrees of freedom = 2||This comparison is for total doses received (26 in Girls OnGuard/HPV Awareness condition compared to 17 in General Health Promotion condition)||||=.12
70964785|NCT02012296|141434690|SUPERIORITY|||||||0.83|||||||Log Rank|||||||0.83
70964786|NCT02012296|141434691|SUPERIORITY|||||||0.21|||||||Log Rank|||||||0.21
70964787|NCT02012296|141434694|SUPERIORITY|||||||0.0012|||||||t-test, 2 sided|||||||0.0012
70964788|NCT02012296|141434695|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70964789|NCT02012296|141434696|SUPERIORITY|||||||0.0002|||||||t-test, 2 sided|||||||0.0002
70964790|NCT01448213|141434697|SUPERIORITY_OR_OTHER|||||||0.17|||||||Log Rank|||||||0.17
70964791|NCT01448213|141434698|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Log Rank|||||||0.0005
70964792|NCT02615470|141434702|SUPERIORITY||||||=|0.202||||||A priori alpha = 0.05|Wilcoxon (Mann-Whitney)|||||||=0.202
70964793|NCT02615470|141434703|SUPERIORITY|||||||0.048|||||||Wilcoxon (Mann-Whitney)|||||||0.048
70964794|NCT02615470|141434704|SUPERIORITY||||||=|0.322||||||a priori alpha = 0.05|Wilcoxon (Mann-Whitney)|||||||=0.322
70964795|NCT01817907|141434706|SUPERIORITY_OR_OTHER|||||||0.52|||||||t-test, 2 sided|||||||0.52
70964796|NCT01830855|141434726|SUPERIORITY_OR_OTHER||Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.93|1.14||||||PMB80 \[A22\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB80.||1.14|0.93|
70964797|NCT01830855|141434726|SUPERIORITY_OR_OTHER||Ratio of GMTs|1.02|||||TWO_SIDED|95.0|0.92|1.13||||||PMB80 \[A22\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB80.||1.13|0.92|
70964798|NCT01830855|141434726|SUPERIORITY_OR_OTHER||Ratio of GMTs|0.99|||||TWO_SIDED|95.0|0.88|1.12||||||PMB80 \[A22\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB80.||1.12|0.88|
70964799|NCT01830855|141434726|SUPERIORITY_OR_OTHER||Ratio of GMTs|0.95|||||TWO_SIDED|95.0|0.85|1.06||||||PMB2948 \[B24\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB2948.||1.06|0.85|
70964800|NCT01830855|141434726|SUPERIORITY_OR_OTHER||Ratio of GMTs|0.95|||||TWO_SIDED|95.0|0.86|1.06||||||PMB2948 \[B24\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB2948.||1.06|0.86|
70964801|NCT01830855|141434726|SUPERIORITY_OR_OTHER||Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.88|1.14||||||PMB2948 \[B24\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB2948||1.14|0.88|
70964802|NCT03034460|141434793|SUPERIORITY||||||=|0.158|||||||Wilcoxon rank signed test|||This analysis was performed in participants applied CD5024 1% Cream on one side of face and CD5024 1% Cream Matched Placebo on other side of face for paired difference between Active - Vehicle (CD5024 1% Cream \[n=48\] versus CD5024 1% Cream Matched Placebo \[n=48\]).||||= 0.158
70964803|NCT03034460|141434793|SUPERIORITY||||||=|0.002|||||||Wilcoxon rank signed test|||This analysis was performed in participants applied Adapalene Benzoyl Peroxyde on one side of face and Adapalene Benzoyl Peroxyde Matched Placebo on the other side of face for paired difference between Active - Vehicle (Adapalene Benzoyl Peroxyde \[n=22\] versus Adapalene Benzoyl Peroxyde Matched Placebo \[n=22\]).||||= 0.002
70964804|NCT02267603|141434820|OTHER|The null hypothesis will be rejected if 3 or more responses are observed in 24 patients. This design yields a type I error rate of 0.10 and power of 0.90 when the true response rate is 25%. Progression-free survival (PFS) at 16 months will be estimated by Kaplan-Meier method. Unless otherwise stated, all statistical tests will be conducted at the α=0.05 (1-sided) level.||||||||||||||||The protocol was designed w/ a standard Simon 2 stage design. Null hypothesis that true response rate is 5% was tested against a 1-sided alternative. In stage 1, 9 patients were accrued. If no responses in these 9 patients, study was to stop. Otherwise,15 more patients were to be accrued for a total of 24 patients. Study was amended to increase number of patients to 50, following discussion w/ pharmaceutical collaborator and FDA.|ORR will be estimated as the # of responders as a % of the # of eligible participants who received at least 1 dose of treatment. If a substantial amount of primary endpoint data are missing (at least 1 value missing from more than 20% of participants), using nonparametric estimation to estimate the ORR requires the missing completely at random assumption may give misleading results. In this case, analyses of the primary endpoint will be performed using parametric generalized linear models fit by maximum likelihood. These methods provide unbiased estimation and inferences under the parametric modeling assumptions and the assumption that the missing data are missing at random (MAR). MAR assumes that the probability of an observation being missing may depend upon the observed responses and upon observed covariates. A generalized linear model for the ORR will use a binomial error distribution. The model will include as covariates all available baseline predictors of the missing outcomes.|||
70964805|NCT01509079|141434845|SUPERIORITY_OR_OTHER|||||||0.38|||||||ANOVA|||||||0.38
70964806|NCT00314249|141434883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.38||||||95.0|-8.56|-4.19|||ANCOVA|||This parameter was analyzed using an ANCOVA model with treatment group and study center as factors and baseline value as a covariate.||-4.19|-8.56|
70964807|NCT00314249|141434884|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53||||||95.0|-0.69|-0.38|||ANOVA|||This parameter was analyzed using an ANOVA model with treatment group and study center as factors.||-0.38|-0.69|
70964808|NCT00314249|141434885|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.69||||||95.0|-3.27|-0.11|||ANCOVA|||This parameter was analyzed using an ANCOVA model with treatment group and study center as factors and baseline value as a covariate.||-0.11|-3.27|
70964809|NCT00314249|141434886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06|||<|0.001||95.0|1.45|2.94||Closed testing procedure used to control overall type 1 error rate at 5%: fibromyalgia syndrome tested prior to fibromyalgia pain|Regression, Logistic|||The test of no difference in the responder rate between milnacipran and placebo groups was performed using a logistic regression model with treatment group, baseline pain score, and baseline SF-36 PCS score as explanatory variables.||2.94|1.45|<0.001
70964810|NCT00314249|141434887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.86|||<|0.001||95.0|1.38|2.51||Closed testing procedure was used to control overall type 1 error rate at 5%: fibromyalgia pain tested after statistically significant fibromyalgia syndrome test|Regression, Logistic|||The test of no difference in the responder rate between milnacipran and placebo groups was performed using a logistic regression model with the treatment group and baseline pain score as explanatory variables.||2.51|1.38|<0.001
70964811|NCT00314249|141434888|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.65||||||95.0|0.86|2.44|||ANCOVA|||This parameter was analyzed using an ANCOVA model with treatment group and study center as factors and baseline value as a covariate.||2.44|0.86|
70964812|NCT03334409|141434914|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
70964813|NCT03334409|141434915|SUPERIORITY|||||||0.08|||||||Log Rank|||||||0.08
70964814|NCT03334409|141434916|SUPERIORITY|||||||0.08|||||||Log Rank|||||||0.08
70964815|NCT03334409|141434917|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
70964816|NCT03334409|141434918|SUPERIORITY|||||||0.18|||||||Kruskal-Wallis|||||||0.18
70964817|NCT03334409|141434919|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
70964818|NCT05395104|141434955|OTHER|Ratio = Geometric least squares mean (test)/geometric least squares mean (reference)|Ratio|1.0865|||||TWO_SIDED|90.0|0.9724|1.2141||||||Midazolam + Cefiderocol: single 5-mg dose of midazolam + 2 g cefiderocol (Day 15)||1.2141|0.9724|
70964819|NCT05395104|141434957|OTHER|Ratio = Geometric least squares mean (test)/geometric least squares mean (reference)|Ratio|1.1174|||||TWO_SIDED|90.0|0.9784|1.2762||||||Midazolam + Cefiderocol: single 5-mg dose of midazolam + 2 g cefiderocol (Day 15)||1.2762|0.9784|
70964820|NCT05395104|141434958|OTHER|Ratio = Geometric least squares mean (test)/geometric least squares mean (reference)|Ratio|1.1239|||||TWO_SIDED|90.0|0.9887|1.2776||||||Midazolam + Cefiderocol: single 5-mg dose of midazolam + 2 g cefiderocol (Day 15)||1.2776|0.9887|
70964821|NCT01892306|141434975|SUPERIORITY_OR_OTHER|||||||0.02|||||||Mixed Models Analysis|||Scores on the HAM-A were analyzed using a mixed-effects linear regression analysis over 6 timepoints.||||.02
70964822|NCT01892306|141434976|SUPERIORITY_OR_OTHER|||||||0.02|||||||Mixed Models Analysis|||Scores on the HAM-D were analyzed using a mixed-effects linear regression analysis over 6 timepoints.||||0.02
70964823|NCT01892306|141434977|SUPERIORITY_OR_OTHER|||||||0.24|||||||Mixed Models Analysis|||Scores on the CSQ were analyzed using a mixed-effects linear regression analysis over 6 timepoints.||||0.24
70964824|NCT01892306|141434978|OTHER|||||||0.62|||||||Regression, Linear|||Linear regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline DERS scores.||||.62
70964825|NCT01892306|141434978|OTHER|||||||0.03|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline DERS scores||||.03
70964826|NCT01892306|141434979|OTHER|||||||0.95|||||||Regression, Linear|||Linear regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline ACS scores.||||0.95
70964827|NCT01892306|141434979|OTHER|||||||0.03|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline ACS scores.||||0.03
70964828|NCT01892306|141434980|OTHER|||||||0.87|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline ASI scores||||0.87
70964829|NCT01892306|141434980|OTHER|||||||0.37|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline ASI scores||||0.37
70964830|NCT01892306|141434981|OTHER|||||||0.17|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline NEO- Neuroticism scores.||||0.17
70964831|NCT01892306|141434981|OTHER|||||||0.04|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline NEO-Neuroticism scores||||.04
70964832|NCT01892306|141434982|OTHER|||||||0.007|||||||Regression, Linear|||Fisher's z-transformed values for functional connectivity between anterior insula and ventrolateral prefrontal cortex were entered in separate treatment group-specific linear regression models as the independent variable with change in primary outcomes (HAM-D) as dependent variable.||||0.007
70964833|NCT01892306|141434982|OTHER|||||||0.14|||||||Regression, Linear|||Fisher's z-transformed values for functional connectivity between anterior insula and ventrolateral prefrontal cortex were entered in separate treatment group-specific linear regression models as the independent variable with change in primary outcomes (HAM-D) as dependent variable.||||.14
70964834|NCT00038727|141435015|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.87|TWO_SIDED|95.0|0.81|1.28|||Log Rank|||||1.28|0.81|0.87
70964835|NCT00038727|141435015|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.95|TWO_SIDED|95.0|0.79|1.25|||Log Rank|||||1.25|0.79|0.95
70964836|NCT01660451|141435129|SUPERIORITY_OR_OTHER_LEGACY||Response rate|45.45||||0.0001|TWO_SIDED|90.0|30.49|61.06||0.0001|Exact binomial test|||Response rate was statistically compared by exact binomial test if higher than 5%.||61.06|30.49|0.0001
70964837|NCT01660451|141435129|SUPERIORITY_OR_OTHER_LEGACY||Response rate|27.08||||0.0001|TWO_SIDED|90.0|16.83|39.57||0.0001|Exact binominal test|P-value was based on the original patients in the aggressive arm (for the first 34 patients), not including the additional recruited patients.||Response rate was statistically compared by exact binomial test if higher than 5%.||39.57|16.83|0.0001
70964838|NCT01660451|141435130|SUPERIORITY_OR_OTHER_LEGACY||Response rate|59.15|||<|0.0001|TWO_SIDED|95.0|50.6|67.32||0.001|Exact binominal test|||Response rate was statistically compared by exact binomial test if higher than 40%.||67.32|50.60|<0.0001
70964839|NCT01660451|141435131|SUPERIORITY_OR_OTHER_LEGACY||Response rate|46.88||||0.0001|TWO_SIDED|90.0|31.54|62.66||0.0001|Exact binominal test|||Response rate was statistically compared by exact binomial test if higher than 5%.||62.66|31.54|0.0001
70964840|NCT01660451|141435131|SUPERIORITY_OR_OTHER_LEGACY||Response rate|31.25||||0.0001|TWO_SIDED|90.0|20.35|43.97||0.0001|Exact binominal test|||Response rate was statistically compared by exact binomial test if higher than 5%.||43.97|20.35|0.0001
70964841|NCT01660451|141435132|SUPERIORITY_OR_OTHER_LEGACY||Response rate|51.41||||0.0039|TWO_SIDED|95.0|42.88|59.87||0.01|Exact binominal test|||Response rate was statistically compared by exact binomial test if higher than 40%.||59.87|42.88|0.0039
70964842|NCT01660451|141435143|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimate|1.0|||||TWO_SIDED|95.0|0.5|2.5||||||Hodges-Lehmann-estimate was used to calculate change to Week 16 and 95% confidence interval.||2.5|0.5|
70964843|NCT01660451|141435144|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimate|0.5|||||TWO_SIDED|95.0|-0.7|3.2||||||Hodges-Lehmann-estimate was used to calculate change to Week 16 and 95% confidence interval.||3.2|-0.7|
70964844|NCT01499953|141435145|NON_INFERIORITY|The hypotheses for non-inferiority test using ∆=4.5% for the difference between incidence rates were H0: πrivaroxaban-πfondaparinux ≥ 4.5%, H1: πrivaroxaban-πfondaparinux \< 4.5% where πfondaparinux and πrivaroxaban were the incidence rates of CIAC confirmed VTE complications up to Day 45 in the treatment groups. Rejection of the null hypothesis would have concluded that rivaroxaban was not inferior to fondaparinux. To calculate the p-value, an asymptotic test for non-inferiority was used.||||||0.0252|||||||asymptotic test for non-inferiority|||||||0.0252
70964845|NCT00523718|141435151|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|TWO_SIDED||||||Chi-squared|||||||.24
70964846|NCT02113579|141435155|SUPERIORITY_OR_OTHER||Success rate difference (%)|24.7|||<|0.001|TWO_SIDED|||||Per statistical analysis plan, if experimental rinse was significantly better than placebo (p\<0.05) with estimated difference of \>= 20%, testing proceeded to Mean Cold Air Stimulus VAS Score at Week 4. Family-wise error was controlled at 0.05.|Regression, Logistic|Study center and mean baseline cold air stimulus VAS score as covariate. For subjects with no score at Week 4, non-response was imputed.|Estimated by calculating the model predicted success probabilities assuming all subjects received 12027-033 and then assuming all subjects received placebo, and then calculating mean of subjects' differences between these predicted probabilities.|The null hypothesis was no difference in success rates between treatment groups. The alternative hypothesis was a difference in success rates between treatment groups.||||<0.001
70964847|NCT02113579|141435156|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-14.27|STANDARD_ERROR_OF_MEAN|2.239|<|0.001|TWO_SIDED|95.0|-18.68|-9.87||Per statistical analysis plan, if experimental rinse was significantly better than placebo (p\<0.05), testing proceeded to Mean Tactile Sensitivity Score at Week 4. Family-wise error was controlled at 0.05.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-9.87|-18.68|<0.001
70964848|NCT02113579|141435157|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|13.45|STANDARD_ERROR_OF_MEAN|1.844|<|0.001|TWO_SIDED|95.0|9.83|17.08||Per statistical analysis plan, if experimental rinse was significantly better than placebo (p\<0.05), testing proceeded to Mean Cold Air Stimulus VAS Score at Week 2 and Mean Tactile Sensitivity Score at Week 2. Family-wise error controlled at 0.05.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||17.08|9.83|<0.001
70964849|NCT02113579|141435158|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.67|STANDARD_ERROR_OF_MEAN|1.809|<|0.001|TWO_SIDED|95.0|-11.23|-4.11||Per statistical analysis plan, Hochberg's method at significance level 0.05 was applied to jointly evaluate secondary outcomes Mean Cold Air Stimulus VAS Score at Wk 2 and Mean Tactile Sensitivity Score at Wk 2. Family-wise error controlled at 0.05.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-4.11|-11.23|<0.001
70964850|NCT02113579|141435159|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|0.975|<|0.001|TWO_SIDED|95.0|2.78|6.62||Per statistical analysis plan, Hochberg's method at significance level 0.05 was applied to jointly evaluate secondary outcomes Mean Cold Air Stimulus VAS Score at Wk 2 and Mean Tactile Sensitivity Score at Wk 2. Family-wise error controlled at 0.05.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||6.62|2.78|<0.001
70964851|NCT02113579|141435160|SUPERIORITY_OR_OTHER||Success rate difference (%)|15.44||||0.002|TWO_SIDED|||||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Regression, Logistic|Study center and mean baseline cold air stimulus VAS score as covariate. For subjects with no score at Week 2, non-response was imputed.|Estimated by calculating the model predicted success probabilities assuming all subjects received 12027-033 and then assuming all subjects received placebo, and then calculating mean of subjects' differences between these predicted probabilities.|The null hypothesis was no difference in success rates between treatment groups. The alternative hypothesis was a difference in success rates between treatment groups.||||0.002
70964852|NCT02113579|141435161|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.67|STANDARD_ERROR_OF_MEAN|1.65|<|0.001|TWO_SIDED|95.0|-9.92|-3.43||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-3.43|-9.92|<0.001
70964853|NCT02113579|141435162|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-11.52|STANDARD_ERROR_OF_MEAN|1.92|<|0.001|TWO_SIDED|95.0|-15.3|-7.75||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-7.75|-15.30|<0.001
70964854|NCT02113579|141435163|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.24|STANDARD_ERROR_OF_MEAN|1.422||0.023|TWO_SIDED|95.0|-6.04|-0.45||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.45|-6.04|0.023
70964855|NCT02113579|141435164|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.61|STANDARD_ERROR_OF_MEAN|1.873|<|0.001|TWO_SIDED|95.0|-11.29|-3.93||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups||-3.93|-11.29|<0.001
70964856|NCT02060383|141435165|OTHER|There was no formal hypothesis testing planned in this study.|Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-0.63|0.08|||||Difference of adjusted mean change in HbA1c between the two arms based on an ANOVA model with treatment (Incretin, Insulin) and randomization stratification factors (Cushing's vs. Acromegaly; baseline HbA1c \<7% vs ≥7%) as fixed effects.|All Patients||0.08|-0.63|
70964857|NCT02060383|141435165|OTHER|There was no formal hypothesis testing planned in this study.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-0.96|0.95|||||Difference of adjusted mean change in HbA1c between the two arms based on an ANOVA model with treatment (Incretin, Insulin) and randomization stratification factors (baseline HbA1c \<7% vs ≥7%) as fixed effects.|Cushing's Disease||0.95|-0.96|
70964858|NCT02060383|141435165|OTHER|There was no formal hypothesis testing planned in this study.|Mean Difference (Net)|-0.36|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|-0.74|0.02|||||Difference of adjusted mean change in HbA1c between the two arms based on an ANOVA model with treatment (Incretin, Insulin) and randomization stratification factors (baseline HbA1c \<7% vs ≥7%) as fixed effects.|Acromegaly||0.02|-0.74|
70964859|NCT03523728|141435192|SUPERIORITY||Relative difference|21.32|||=|0.1367|TWO_SIDED|95.0|-5.77|58.22|||linear mixed effect model|||||58.22|-5.77|=0.1367
70964860|NCT03523728|141435192|SUPERIORITY||Relative difference|0.34|||=|0.9812|TWO_SIDED|95.0|-24.57|33.36|||linear mixed effect model|||||33.36|-24.57|=0.9812
70964861|NCT03523728|141435193|SUPERIORITY||Relative difference|101.32|||=|0.0005|TWO_SIDED|95.0|35.63|233.72|||linear mixed effect model|||||233.72|35.63|=0.0005
70964862|NCT03523728|141435193|SUPERIORITY||Relative difference|104.17|||=|0.0002|TWO_SIDED|95.0|39.54|236.45|||linear mixed effect model|||||236.45|39.54|=0.0002
70964863|NCT03523728|141435194|SUPERIORITY||Relative difference|51.01|||=|0.0197|TWO_SIDED|95.0|7.01|125.45|||linear mixed effect model|||||125.45|7.01|=0.0197
70964864|NCT03523728|141435194|SUPERIORITY||Relative difference|46.36|||=|0.0337|TWO_SIDED|95.0|3.21|119.01|||linear mixed effect model|||||119.01|3.21|=0.0337
70964865|NCT03523728|141435196|SUPERIORITY||Least square mean difference|0.11|STANDARD_ERROR_OF_MEAN|0.23|=|0.6374|TWO_SIDED|95.0|-0.342|0.556|||Mixed effect model with repeated measure|||||0.556|-0.342|=0.6374
70964866|NCT03523728|141435196|SUPERIORITY||Least square mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.22|=|0.256|TWO_SIDED|95.0|-0.689|0.185|||Mixed effect model with repeated measure|||||0.185|-0.689|=0.2560
70964867|NCT03523728|141435197|SUPERIORITY||Least square mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.42|=|0.79|TWO_SIDED|95.0|-0.971|0.747|||Mixed effect model with repeated measure|||||0.747|-0.971|=0.7900
70964868|NCT03523728|141435197|SUPERIORITY||Least square mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.32|=|0.6322|TWO_SIDED|95.0|-0.808|0.5|||Mixed effect model with repeated measure|||||0.500|-0.808|=0.6322
70964869|NCT03523728|141435198|SUPERIORITY||Least square mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.34|=|0.6245|TWO_SIDED|95.0|-0.506|0.839|||Mixed effect model with repeated measure|||||0.839|-0.506|=0.6245
70964870|NCT03523728|141435198|SUPERIORITY||Least square mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.33|=|0.2567|TWO_SIDED|95.0|-1.044|0.281|||Mixed effect model with repeated measure|||||0.281|-1.044|=0.2567
70964871|NCT03523728|141435199|SUPERIORITY||Least square mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.68|=|0.2023|TWO_SIDED|95.0|-2.232|0.485|||Mixed effect model with repeated measure|||||0.485|-2.232|=0.2023
70964872|NCT03523728|141435199|SUPERIORITY||Least square mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.53|=|0.3205|TWO_SIDED|95.0|-1.61|0.537|||Mixed effect model with repeated measure|||||0.537|-1.610|=0.3205
70964873|NCT00621751|141435212|OTHER||Median Difference (Final Values)|36.7||||0.6|TWO_SIDED|||||CBZ (up to 800 mg daily) vs placebo significantly improves behavior (Rasch NPI irritability \& aggression rated by observer) baseline to day-42 among individuals \>6 months post-traumatic brain injury and moderate-severe irritability.|ANCOVA|||The primary outcome was a composite measure of observer-rated NPI-I \& NPI-A domains transformed to a Rasch logit scale ranging 0 (best) to 100 (worse) units (i.e., observer-rated NPI-I/A Rasch construct scores). Mean day-42 observer-rated NPI-I/A Rasch construct scores were compared between the placebo vs. carbamazepine groups using ANCOVA with baseline score as covariate.||||0.60
70964874|NCT00621751|141435213|OTHER|A prespecified secondary analysis compared proportions of participants that experienced a decrease of \> 1 MCID in the NPI-I/A Rasch construct score (i.e., participants that are considered to have meaningful reduction in irritability/aggression) from baseline to day-42 between the groups using a chi-square test. MCID was defined as 0.5 times the standard deviation of baseline scores.|||||<|0.05|||||||ANCOVA|||||||< .05
70964875|NCT01809132|141435243|SUPERIORITY|||||||0.3|||||||Log Rank|||||||.30
70964876|NCT01809132|141435244|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||the observational subject was lost to follow-up||||.42
70964877|NCT01809132|141435245|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||||||.75
70964878|NCT01809132|141435246|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||.17
70964879|NCT00307333|141435290|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||t-test, 2 sided|||||||0.08
70964880|NCT00307333|141435291|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||t-test, 2 sided|||||||0.47
70964881|NCT00307333|141435292|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||t-test, 2 sided|||||||0.31
70964882|NCT00307333|141435293|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.61|0.99|||||HR = hazard for intervention / hazard for control|||0.99|0.61|
70964883|NCT01572675|141435335|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||p-student|||Group comparison (Arcoxia® \[Initiation\] vs Arcoxia® \[Renewal\]) for duration of prescription at enrollment||||<0.001
70964884|NCT01572675|141435335|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||p-student|||Group comparison (Celebrex® \[Initiation\] vs Celebrex® \[Renewal\]) for duration of prescription at enrollment||||<0.001
70964885|NCT01572675|141435340|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||Duration of treatment comparison (More than one year vs Up to thirty days) for intermittent selective COX-2 inhibitor use. The analysis assessed whether long-term treatment was more correlated with intermittent selective COX-2 inhibitor use compared to short-term treatment.||||<0.001
70964886|NCT01572675|141435343|SUPERIORITY_OR_OTHER_LEGACY|||||||0.104|||||||Chi-squared|||Group comparison (Arcoxia® vs Celebrex®) for controlled BP (SBP \<140 mmHg and DBP \<90 mmHg) at study entry||||0.104
70964887|NCT01572675|141435343|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0049|||||||Chi-squared|||Group comparison (Arcoxia® \[Initiation\] vs Arcoxia® \[Renewal\]) for controlled BP (SBP \<140 mmHg and DBP \<90 mmHg) at study entry||||0.0049
70964888|NCT01572675|141435343|SUPERIORITY_OR_OTHER_LEGACY|||||||0.618|||||||Chi-squared|||Group comparison (Celebrex® \[Initiation\] vs Celebrex® \[Renewal\]) for controlled BP (SBP \<140 mmHg and DBP \<90 mmHg) at study entry||||0.618
70964889|NCT01572675|141435344|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|||||||Chi-squared|||Group comparison (Arcoxia® \[Initiation\] vs Arcoxia® \[Renewal\]) for medical history of arterial hypertension||||0.012
70964890|NCT01572675|141435344|SUPERIORITY_OR_OTHER_LEGACY|||||||0.175|||||||Chi-squared|||Group comparison (Celebrex® \[Initiation\] vs Celebrex® \[Renewal\]) for medical history of arterial hypertension||||0.175
70964891|NCT01572675|141435346|SUPERIORITY_OR_OTHER_LEGACY|||||||0.701|||||||Chi-squared|||Group comparison (Arcoxia® \[Initiation\] vs Arcoxia® \[Renewal\]) for significant past treatments||||0.701
70964892|NCT01572675|141435346|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||Chi-squared|||Group comparison (Celebrex® \[Initiation\] vs Celebrex® \[Renewal\]) for significant past treatments||||0.007
70964893|NCT01572675|141435346|SUPERIORITY_OR_OTHER_LEGACY|||||||0.955|||||||Chi-squared|||Group comparison (Arcoxia® vs Celebrex®) for significant past treatments||||0.955
70964894|NCT01572675|141435349|SUPERIORITY_OR_OTHER_LEGACY|||||||0.049|||||||Fisher Exact|||Group comparsion (Arcoxia® vs Celebrex®) for previous treatment with other agents prior to initiation of Arcoxia® and Celebrex® for the main study indications||||0.049
70964895|NCT01572675|141435352|SUPERIORITY_OR_OTHER_LEGACY|||||||0.165|||||||Chi-squared|||Group comparsion (Arcoxia® vs Celebrex®) of adverse events experienced during treatment||||0.165
70964896|NCT00223678|141435357|SUPERIORITY_OR_OTHER|||||||0.849|||||||Log Rank|||||||0.849
70964897|NCT03346057|141435358|OTHER||Estimated Difference in percentage|-6.7||||0.026|TWO_SIDED|95.0|-17.5|-0.8|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by neuromuscular blocking agent (NMBA) and American Society of Anesthesiologists (ASA) class was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||-0.8|-17.5|0.026
70964898|NCT03346057|141435358|OTHER||Estimated Difference in percentage|-6.2||||0.058|TWO_SIDED|95.0|-17.3|0.2|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||0.2|-17.3|0.058
70964899|NCT03346057|141435358|OTHER||Estimated Difference in percentage|-2.0||||0.73|TWO_SIDED|95.0|-17.8|8.6|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||8.6|-17.8|0.730
70964900|NCT03346057|141435359|OTHER||Estimated Difference in percentage|-14.9||||0.007|TWO_SIDED|95.0|-28.8|-4.0|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||-4.0|-28.8|0.007
70964901|NCT03346057|141435359|OTHER||Estimated Difference in percentage|-12.2||||0.036|TWO_SIDED|95.0|-26.1|-0.8|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||-0.8|-26.1|0.036
70964902|NCT03346057|141435359|OTHER||Estimated Difference in percentage|-9.9||||0.158|TWO_SIDED|95.0|-27.6|3.6|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||3.6|-27.6|0.158
70964903|NCT03346057|141435360|OTHER||Estimated Difference in percentage|-0.9||||0.637|TWO_SIDED|95.0|-9.4|4.0|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||4.0|-9.4|0.637
70964904|NCT03346057|141435360|OTHER||Estimated Difference in percentage|-2.1||||0.134|TWO_SIDED|95.0|-10.6|1.5|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||1.5|-10.6|0.134
70964905|NCT03346057|141435360|OTHER||Estimated Difference in percentage|-1.7||||0.577|TWO_SIDED|95.0|-14.7|5.8|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||5.8|-14.7|0.577
70964906|NCT03346057|141435361|OTHER||Estimated Difference in percentage|6.2|||||TWO_SIDED|95.0|-2.6|18.5||||||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||18.5|-2.6|
70964907|NCT03346057|141435361|OTHER||Estimated Difference in percentage|0.5|||||TWO_SIDED|95.0|-9.3|13.1||||||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||13.1|-9.3|
70964908|NCT03346057|141435361|OTHER||Estimated Difference in percentage|2.0|||||TWO_SIDED|95.0|-8.4|17.7||||||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||17.7|-8.4|
70964909|NCT03346057|141435362|OTHER||Estimated Difference in percentage|5.6|||||TWO_SIDED|95.0|-5.5|14.3||||||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||14.3|-5.5|
70964910|NCT03346057|141435362|OTHER||Estimated Difference in percentage|1.5|||||TWO_SIDED|95.0|-9.2|9.3||||||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||9.3|-9.2|
70964911|NCT03346057|141435362|OTHER||Estimated Difference in percentage|0.9|||||TWO_SIDED|95.0|-15.1|12.7||||||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||12.7|-15.1|
70964912|NCT03346057|141435363|OTHER||Estimated Difference in percentage|-2.1|||||TWO_SIDED|95.0|-11.8|3.8||||||The percentage of participants experiencing one or more ECIs was compared between the Sugammadex 2 mg/kg arm and the Neostigmine plus Glycopyrrolate arm. Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||3.8|-11.8|
70964913|NCT03346057|141435363|OTHER||Estimated Difference in percentage|1.8|||||TWO_SIDED|95.0|-8.1|8.4||||||The percentage of participants experiencing one or more ECIs was compared between the Sugammadex 4 mg/kg arm and the Neostigmine plus Glycopyrrolate arm. Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||8.4|-8.1|
70964914|NCT03346057|141435363|OTHER||Estimated Difference in percentage|1.1|||||TWO_SIDED|95.0|-13.5|11.1||||||The percentage of participants experiencing one or more ECIs was compared between the Sugammadex 16 mg/kg arm and the Neostigmine plus Glycopyrrolate arm. Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||11.1|-13.5|
70964915|NCT01159912|141435374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.146||||0.009|TWO_SIDED|95.0|0.036|0.257|||ANCOVA|||||0.257|0.036|0.009
70964916|NCT01159912|141435374|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.145||||0.011|TWO_SIDED|95.0|0.033|0.257|||ANCOVA|||||0.257|0.033|0.011
70964917|NCT02456662|141435382|SUPERIORITY|Based on previous work as well as anecdotal data from our clinic population, we expect vomiting to occur in approximately 30% of our patients who take their doxycycline the night before their procedure. To have 80% power to detect a 50% decrease in nausea and vomiting, we will need 122 patients in each arm of the study.||||||0|||||||Chi-squared|||||||0.00
70964918|NCT01353079|141435387|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.834|||<|0.05|TWO_SIDED|95.0|-1.298|-0.369|||ANCOVA|||||-0.369|-1.298|<0.05
70964919|NCT01353079|141435388|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.857|||<|0.05|TWO_SIDED|95.0|-1.388|-0.326|||ANCOVA|||||-0.326|-1.388|<0.05
70964920|NCT01353079|141435389|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.771|||<|0.05|TWO_SIDED|95.0|-1.213|-0.329|||ANCOVA|||||-0.329|-1.213|<0.05
70964921|NCT01353079|141435390|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.788|||<|0.05|TWO_SIDED|95.0|-1.291|-0.284|||ANCOVA|||||-0.284|-1.291|<0.05
70964922|NCT02281357|141435408|SUPERIORITY|The null hypothesis was that the average percentage change in OCS dose on tralokinumab was equal to the average percentage change in OCS dose on placebo.|LS Mean difference|-7.78||||0.271|TWO_SIDED|95.0|-21.7|6.15|||ANCOVA|The analysis of covariance (ANCOVA) model utilised a sandwich estimator for the variance.|The model included treatment group as a fixed effect and baseline OCS dose as a continuous covariate. No interaction terms were included in the model. All group comparisons from the ANCOVA model were based on Type III sums of squares.|Comparison of percent change from baseline in OCS dose: tralokinumab vs placebo.||6.15|-21.70|0.271
70964923|NCT02281357|141435409|SUPERIORITY||Odds Ratio (OR)|1.33||||0.442|TWO_SIDED|95.0|0.65|2.73|||Regression, Logistic|The model included treatment group as a fixed effect and baseline OCS dose as a continuous covariate.||Comparison of OCS dose ≤5.0 mg: tralokinumab vs placebo.||2.73|0.65|0.442
70964924|NCT02281357|141435410|SUPERIORITY||Odds Ratio (OR)|1.38||||0.356|TWO_SIDED|95.0|0.7|2.74|||Regression, Logistic|The model included treatment group as a fixed effect and baseline OCS dose as a continuous covariate.||Comparison of ≥50% reduction in OCS dose: tralokinumab vs placebo.||2.74|0.70|0.356
70964925|NCT02281357|141435411|SUPERIORITY||Rate Ratio|0.8||||0.186|TWO_SIDED|95.0|0.57|1.12|||Negative binomial||Treatment group, OCS dose at baseline, and number of exacerbations in the previous year are included in the model as covariates.|Comparison of AAER: tralokinumab vs placebo.||1.12|0.57|0.186
70964926|NCT05314712|141435412|OTHER|Linear Mixed Model (repeated measures model) of sleep trouble||||||||||||There was no hypothesis test. All participants received the 7-week intervention - there was no comparison group. A variable selection approach (AIC) was used for including the final variables in the model.||||Since all participants in this pilot study received in the intervention and data was collected pre and post intervention, there was no hypothesis test. Under the assumption that the likert scale data was treated as continuous, the data was analyzed using a linear mixed model. Variables in final model were included after variable selection (details below).|Using an exhaustive search of all models (dredge) that could be formed from predictor variables partner sleep rating, perceived stress, DASS scale, 8-item diet scale, amount of screen time, amount of time between bed time and wake time, amount of time to fall asleep, hours of sleep, sleep rating score, indicator variable if the child played outside, bed time, and wake time, adult height in inches, adult BMI, adult's highest education attained, the number of children in the household, grade of the child, child height in inches, child BMI, age of the child, and gender of the child, requiring the the timing of the survey be in the model, and accounting for repeated measurements over time, using AIC as the selection criterion we looked for the model with the smallest AIC value. The final sleep trouble model included the covariates timing of survey, DASS scale, and indicator variable if child played outside.|||
70964927|NCT05314712|141435412|OTHER|Mixed effects linear regression model of hours slept||||||||||||There was no hypothesis test. All participants received the 7-week intervention - there was no comparison group. A variable selection approach (AIC) was used for including the final variables in the model.||||Since all participants in this pilot study received in the intervention and data was collected pre and post intervention, there was no hypothesis test. The data was analyzed using a mixed effects linear regression model. Variables in final model were included after variable selection (details below).|Using an exhaustive search of all models (dredge) that could be formed from predictor variables partner sleep rating, perceived stress, DASS scale, 8-item diet scale, amount of screen time, amount of time between bed time and wake time, amount of time to fall asleep, hours of sleep, sleep rating score, indicator variable if the child played outside, bed time, and wake time, adult height in inches, adult BMI, adult's highest education attained, the number of children in the household, grade of the child, child height in inches, child BMI, age of the child, and gender of the child, requiring the the timing of the survey be in the model, and accounting for repeated measurements over time, using AIC as the selection criterion we looked for the model with the smallest AIC value. The final model for hours slept included the covariates number of children in the household, indicator variable if child played outside, and baseline hours slept.|||
70964928|NCT00823303|141435438|NON_INFERIORITY_OR_EQUIVALENCE|On the basis of prior published reports, we estimated a 5% rate of hypercalcemia with paricalcitol and a 30% rate with calcitriol. To have a 90% power to detect a difference at the P=0.05 confidence level, 42 patients per group were needed. Assuming a 30% dropout rate over the course of the study, we planned to randomize 110 patients.||||||0.36|||||||Fisher Exact|||||||0.36
70964929|NCT02592551|141435563|OTHER||Median Difference (Final Values)|8.6||||0.109|TWO_SIDED||||||Wilcoxon signed rank test|||Compare in ratios of intratumoral cytotoxic T cells to regulatory T cells (CD8/Treg) between pre and post of MEDI4736+Tremelimumab||||0.109
70964930|NCT02592551|141435564|OTHER|Compare the tissue biomarker for the immune response of ICOS+ CD4 T cells to before and after MEDI-4736 and Tremelimumab||||||1|||||||Wilcoxon signed rank test|||||||1
70964931|NCT02592551|141435565|OTHER|||||||0.461|||||||Wilcoxon signed rank test|||Compare tumor expression programmed death-ligand 1 (PD-L1) before and after treatment with combination MEDI-4736 and Tremelimumab||||0.461
70964932|NCT02592551|141435566|OTHER|||||||0.954|||||||Wilcoxon (Mann-Whitney)|||Compare tissue biomarker immune response of CD8 and Treg (ratio of CD8/treg) after MEDI-4736 and Tremelimumab, and after MEDI4736 alone||||0.954
70964933|NCT02592551|141435567|OTHER|||||||0.799|||||||Wilcoxon (Mann-Whitney)|||Compare tissue biomarker immune response of CD8 and Treg(ratio of CD8/Treg) after MEDI-4736 and Tremelimumab, and at day 1 of untread control group||||0.799
70964934|NCT02592551|141435570|OTHER|||||||0.418|||||||Wilcoxon (Mann-Whitney)|||Compare tumor expression programmed death-ligand 1 (PD-L1) after combination therapy (MEDI-4736 and Tremelimumab) and after MEDI-4736 alone||||0.418
70964935|NCT02592551|141435571|OTHER|||||||0.932|||||||Wilcoxon (Mann-Whitney)|||Compare tumor expression programmed death-ligand 1 (PD-L1) after combination therapy (MEDI-4736 and Tremelimumab) and before and at day 1 of untreated||||0.932
70964936|NCT02137512|141435599|SUPERIORITY|No adjustments were made for multiple comparisons.|||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70964937|NCT02137512|141435599|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70964938|NCT02137512|141435599|SUPERIORITY|||||||0.31||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.31
70964939|NCT02137512|141435600|SUPERIORITY|||||||0.002||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.002
70964940|NCT02137512|141435600|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70964941|NCT02137512|141435600|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70964942|NCT02137512|141435601|SUPERIORITY|||||||0.1||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.10
70964943|NCT02137512|141435601|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70964944|NCT02137512|141435601|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70964945|NCT02137512|141435602|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70964946|NCT02137512|141435602|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70964947|NCT02137512|141435602|SUPERIORITY|||||||0.91||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.91
70964948|NCT02137512|141435603|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70964949|NCT02137512|141435603|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70964950|NCT02137512|141435603|SUPERIORITY|||||||0.2||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.20
70964951|NCT02137512|141435604|SUPERIORITY|||||||0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.001
70964952|NCT02137512|141435604|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70964953|NCT02137512|141435604|SUPERIORITY|||||||0.49||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.49
70964954|NCT02137512|141435605|SUPERIORITY|||||||0.009||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.009
70964955|NCT02137512|141435605|SUPERIORITY|||||||0.14||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.14
70964956|NCT02137512|141435605|SUPERIORITY|||||||0.06||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.06
70964957|NCT02137512|141435606|SUPERIORITY|||||||0.002||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.002
70964958|NCT02137512|141435606|SUPERIORITY|||||||0.03||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.03
70964959|NCT02137512|141435606|SUPERIORITY|||||||0.18||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.18
70964960|NCT02137512|141435607|SUPERIORITY|||||||0.07||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.07
70964961|NCT02137512|141435607|SUPERIORITY|||||||0.54||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.54
70964962|NCT02137512|141435607|SUPERIORITY|||||||0.07||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.07
70964963|NCT02137512|141435608|SUPERIORITY|||||||0.005||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.005
70964964|NCT02137512|141435608|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70964965|NCT02137512|141435608|SUPERIORITY|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.02
70964966|NCT02137512|141435609|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70964967|NCT02137512|141435609|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70964968|NCT02137512|141435609|SUPERIORITY|||||||0.52||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.52
70964969|NCT02137512|141435610|SUPERIORITY|||||||0.13||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.13
70964970|NCT02137512|141435610|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70964971|NCT02137512|141435610|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70964972|NCT02137512|141435611|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70964973|NCT02137512|141435611|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70964974|NCT02137512|141435611|SUPERIORITY|||||||0.41||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.41
70964975|NCT02137512|141435612|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70964976|NCT02137512|141435612|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70964977|NCT02137512|141435612|SUPERIORITY|||||||0.12||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.12
70964978|NCT02137512|141435613|SUPERIORITY|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.02
70964979|NCT02137512|141435613|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70964980|NCT02137512|141435613|SUPERIORITY|||||||0.06||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.06
70964981|NCT02137512|141435614|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70964982|NCT02137512|141435614|SUPERIORITY|||||||0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.001
70964983|NCT02137512|141435614|SUPERIORITY|||||||0.26||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.26
70964984|NCT02137512|141435615|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70964985|NCT02137512|141435615|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70964986|NCT02137512|141435615|SUPERIORITY|||||||0.11||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.11
70964987|NCT02137512|141435616|SUPERIORITY|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.02
70964988|NCT02137512|141435616|SUPERIORITY|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.02
70964989|NCT02137512|141435616|SUPERIORITY|||||||0.61||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.61
70964990|NCT02137512|141435617|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70964991|NCT02137512|141435617|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70964992|NCT02137512|141435617|SUPERIORITY|||||||0.29||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.29
70964993|NCT02137512|141435618|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70964994|NCT02137512|141435618|SUPERIORITY|||||||0.005||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.005
70964995|NCT02137512|141435618|SUPERIORITY||||||>|0.99||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||>0.99
70964996|NCT02137512|141435619|SUPERIORITY|||||||0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.006
70964997|NCT02137512|141435619|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70964998|NCT02137512|141435619|SUPERIORITY|||||||0.09||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.09
70964999|NCT02137512|141435620|SUPERIORITY|||||||0.002||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.002
70965000|NCT02137512|141435620|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965001|NCT02137512|141435620|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965002|NCT02137512|141435621|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965003|NCT02137512|141435621|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965004|NCT02137512|141435621|SUPERIORITY|||||||0.26||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.26
70965005|NCT02137512|141435622|SUPERIORITY|||||||0.04||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.04
70965006|NCT02137512|141435622|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965007|NCT02137512|141435622|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965008|NCT02137512|141435623|SUPERIORITY|||||||0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.006
70965009|NCT02137512|141435623|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965010|NCT02137512|141435623|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965011|NCT02137512|141435624|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 1 sided|||||||<0.001
70965012|NCT02137512|141435624|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965013|NCT02137512|141435624|SUPERIORITY|||||||0.53||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.53
70965014|NCT02137512|141435625|SUPERIORITY|||||||0.05||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.05
70965015|NCT02137512|141435625|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965016|NCT02137512|141435625|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965017|NCT02137512|141435626|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965018|NCT02137512|141435626|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965019|NCT02137512|141435626|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965020|NCT02137512|141435627|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965021|NCT02137512|141435627|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965022|NCT02137512|141435627|SUPERIORITY|||||||0.22||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.22
70965023|NCT02137512|141435628|SUPERIORITY|||||||0.03||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.03
70965024|NCT02137512|141435628|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965025|NCT02137512|141435628|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965026|NCT02137512|141435629|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965027|NCT02137512|141435629|SUPERIORITY|||||||0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.001
70965028|NCT02137512|141435629|SUPERIORITY|||||||0.26||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.26
70965029|NCT02137512|141435630|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965030|NCT02137512|141435630|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965031|NCT02137512|141435630|SUPERIORITY|||||||0.05||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.05
70965032|NCT02137512|141435631|SUPERIORITY|||||||0.03||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.03
70965033|NCT02137512|141435631|SUPERIORITY|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.02
70965034|NCT02137512|141435631|SUPERIORITY|||||||0.52||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.52
70965035|NCT02137512|141435632|SUPERIORITY|||||||0.003||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.003
70965036|NCT02137512|141435632|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965037|NCT02137512|141435632|SUPERIORITY|||||||0.71||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.71
70965038|NCT02137512|141435633|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965039|NCT02137512|141435633|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965040|NCT02137512|141435633|SUPERIORITY|||||||0.39||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.39
70965041|NCT02137512|141435634|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965042|NCT02137512|141435634|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965043|NCT02137512|141435634|SUPERIORITY|||||||0.06||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.06
70965044|NCT02137512|141435635|SUPERIORITY|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.02
70965045|NCT02137512|141435635|SUPERIORITY|||||||0.003||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.003
70965046|NCT02137512|141435635|SUPERIORITY|||||||0.86||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.86
70965047|NCT02137512|141435636|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965048|NCT02137512|141435636|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965049|NCT02137512|141435636|SUPERIORITY|||||||0.74||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.74
70965050|NCT02137512|141435637|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965051|NCT02137512|141435637|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965052|NCT02137512|141435637|SUPERIORITY|||||||0.09||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.09
70965053|NCT02137512|141435638|SUPERIORITY|||||||0.07||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.07
70965054|NCT02137512|141435638|SUPERIORITY|||||||0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.006
70965055|NCT02137512|141435638|SUPERIORITY|||||||0.68||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.68
70965056|NCT02137512|141435639|SUPERIORITY|||||||0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.006
70965057|NCT02137512|141435639|SUPERIORITY|||||||0.005||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.005
70965058|NCT02137512|141435639|SUPERIORITY|||||||0.62||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.62
70965059|NCT02137512|141435640|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965060|NCT02137512|141435640|SUPERIORITY|||||||0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.006
70965061|NCT02137512|141435640|SUPERIORITY|||||||0.23||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.23
70965062|NCT02137512|141435641|SUPERIORITY|||||||0.67||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.67
70965063|NCT02137512|141435641|SUPERIORITY|||||||0.09||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.09
70965064|NCT02137512|141435641|SUPERIORITY|||||||0.22||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.22
70965065|NCT02137512|141435642|SUPERIORITY|||||||0.25||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.25
70965066|NCT02137512|141435643|SUPERIORITY|||||||0.23||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.23
70965067|NCT02137512|141435644|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965068|NCT02137512|141435645|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965069|NCT02137512|141435646|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965070|NCT02137512|141435647|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
70965071|NCT02137512|141435648|SUPERIORITY|||||||0.01||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.01
70965072|NCT02137512|141435649|SUPERIORITY|||||||0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.006
70965073|NCT02137512|141435650|SUPERIORITY|||||||0.14||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.14
70965074|NCT01086410|141435676|SUPERIORITY_OR_OTHER||Ratio of least square gometric mean|0.99|||||TWO_SIDED|95.0|0.87|1.12|||||Analysis was performed using Analysis of Covariance (ANCOVA) with covariates of region, sex, age, treatment, and the log of the Baseline values.|||1.12|0.87|
70965075|NCT01086410|141435676|SUPERIORITY_OR_OTHER||Ratio of least square gometric mean|0.97|||||TWO_SIDED|95.0|0.86|1.1|||||Analysis was performed using ANCOVA with covariates of region, sex, age, treatment, and the log of the Baseline values.|||1.10|0.86|
70965076|NCT01086410|141435676|SUPERIORITY_OR_OTHER||Ratio of least square gometric mean|0.34|||||TWO_SIDED|95.0|0.28|0.41|||||Analysis performed using ANCOVA with covariates of region, sex, age, treatment, and the log of the Baseline values.|||0.41|0.28|
70965077|NCT02953639|141435698|SUPERIORITY||Treatment Difference|-0.36||||0.73|TWO_SIDED|90.0|-2.11|1.38|||Mixed Models Analysis|||Week 12 Day 84||1.38|-2.11|0.730
70965078|NCT02953639|141435698|SUPERIORITY||Treatment Difference|0.28||||0.793|TWO_SIDED|90.0|-1.47|2.02|||Mixed Models Analysis|||Week 24 Day 168||2.02|-1.47|0.793
70965079|NCT02953639|141435699|SUPERIORITY||Treatment Difference|-0.91||||0.556|TWO_SIDED|90.0|-3.46|1.64|||Mixed Models Analysis|||Week 12 Day 84 (Attention/Vigilance)||1.64|-3.46|0.556
70965080|NCT02953639|141435699|SUPERIORITY||Treatment Difference|-0.27||||0.848|TWO_SIDED|90.0|-2.59|2.05|||Mixed Models Analysis|||Week 24 Day 168 (Attention/Vigilance)||2.05|-2.59|0.848
70965081|NCT02953639|141435699|SUPERIORITY||Treatment Difference|0.04||||0.973|TWO_SIDED|90.0|-2.08|2.16|||Mixed Models Analysis|||Week 12 Day 84 (Reasoning and Problem Solving)||2.16|-2.08|0.973
70965082|NCT02953639|141435699|SUPERIORITY||Treatment Difference|0.57||||0.651|TWO_SIDED|90.0|-1.53|2.67|||Mixed Models Analysis|||Week 24 Day 168 (Reasoning and Problem Solving)||2.67|-1.53|0.651
70965083|NCT02953639|141435699|SUPERIORITY||Treatment Difference|-1.44||||0.35|TWO_SIDED|90.0|-3.89|1.08|||Mixed Models Analysis|||Week 12 Day 84 (Social Cognition)||1.08|-3.89|0.350
70965084|NCT02953639|141435699|SUPERIORITY||Treatment Difference|2.18||||0.121|TWO_SIDED|90.0|-0.14|4.5|||Mixed Models Analysis|||Week 24 Day 168 (Social Cognition)||4.50|-0.14|0.121
70965085|NCT02953639|141435699|SUPERIORITY||Treatment Difference|-0.13||||0.911|TWO_SIDED|90.0|-2.1|1.83|||Mixed Models Analysis|||Week 12 Day 84 (Speed of Processing)||1.83|-2.10|0.911
70965086|NCT02953639|141435699|SUPERIORITY||Treatment Difference|0.02||||0.987|TWO_SIDED|90.0|-1.99|2.03|||Mixed Models Analysis|||Week 24 Day 168 (Speed of Processing)||2.03|-1.99|0.987
70965087|NCT02953639|141435699|SUPERIORITY||Treatment Difference|-0.34||||0.803|TWO_SIDED|90.0|-2.62|1.93|||Mixed Models Analysis|||Week 12 Day 84 (Verbal Learning)||1.93|-2.62|0.803
70965088|NCT02953639|141435699|SUPERIORITY||Treatment Difference|-0.94||||0.502|TWO_SIDED|90.0|-3.26|1.38|||Mixed Models Analysis|||Week 24 Day 168 (Verbal Learning)||1.38|-3.26|0.502
70965089|NCT02953639|141435699|SUPERIORITY||Treatment Difference|-0.11||||0.945|TWO_SIDED|90.0|-2.74|2.52|||Mixed Models Analysis|||Week 12 Day 84 (Visual Learning)||2.52|-2.74|0.945
70965090|NCT02953639|141435699|SUPERIORITY||Treatment Difference|1.11||||0.488|TWO_SIDED|90.0|-1.54|3.76|||Mixed Models Analysis|||Week 24 Day 168 (Visual Learning)||3.76|-1.54|0.488
70965091|NCT02953639|141435699|SUPERIORITY||Treatment Difference|-1.37||||0.262|TWO_SIDED|90.0|-3.38|0.64|||Mixed Models Analysis|||Week 12 Day 84 (Working Memory)||0.64|-3.38|0.262
70965092|NCT02953639|141435699|SUPERIORITY||Treatment Difference|-0.89||||0.489|TWO_SIDED|90.0|-3.01|1.23|||Mixed Models Analysis|||Week 24 Day 168 (Working Memory)||1.23|-3.01|0.489
70965093|NCT02953639|141435700|SUPERIORITY||Treatment Difference|-1.63||||0.211|TWO_SIDED|90.0|-3.78|0.52|||Mixed Models Analysis|||Week 12 Day 84 (VPA I total raw score)||0.52|-3.78|0.211
70965094|NCT02953639|141435700|SUPERIORITY||Treatment Difference|0.35||||0.787|TWO_SIDED|90.0|-1.81|2.52|||Mixed Models Analysis|||Week 24 Day 168 (VPA I total raw score)||2.52|-1.81|0.787
70965095|NCT02953639|141435700|SUPERIORITY||Treatment Difference|0.28||||0.477|TWO_SIDED|90.0|-0.37|0.94|||Mixed Models Analysis|||Week 12 Day 84 (VPA II total raw score)||0.94|-0.37|0.477
70965096|NCT02953639|141435700|SUPERIORITY||Treatment Difference|0.91||||0.028|TWO_SIDED|90.0|0.23|1.58|||Mixed Models Analysis|||Week 24 Day 168 (VPA II total raw score)||1.58|0.23|0.028
70965097|NCT02953639|141435700|SUPERIORITY||Treatment Difference|-0.3||||0.683|TWO_SIDED|90.0|-1.51|0.91|||Mixed Models Analysis|||Week 12 Day 84 (VPA II recognition total raw score)||0.91|-1.51|0.683
70965098|NCT02953639|141435700|SUPERIORITY||Treatment Difference|0.04||||0.954|TWO_SIDED|90.0|-1.13|1.22|||Mixed Models Analysis|||Week 24 Day 168 (VPA II recognition total raw score)||1.22|-1.13|0.954
70965099|NCT02953639|141435701|SUPERIORITY||Treatment Difference|1.45||||0.164|TWO_SIDED|90.0|-0.27|3.17|||Mixed Models Analysis|||Week 12 Day 84 (LM I)||3.17|-0.27|0.164
70965100|NCT02953639|141435701|SUPERIORITY||Treatment Difference|0.56||||0.559|TWO_SIDED|90.0|-1.02|2.14|||Mixed Models Analysis|||Week 24 Day 168 (LM I)||2.14|-1.02|0.559
70965101|NCT02953639|141435701|SUPERIORITY||Treatment Difference|0.12||||0.912|TWO_SIDED|90.0|-1.7|1.94|||Mixed Models Analysis|||Week 12 Day 84 (LM II)||1.94|-1.70|0.912
70965102|NCT02953639|141435701|SUPERIORITY||Treatment Difference|-0.36||||0.706|TWO_SIDED|90.0|-1.93|1.22|||Mixed Models Analysis|||Week 24 Day 168 (LM II)||1.22|-1.93|0.706
70965103|NCT02953639|141435702|SUPERIORITY||Treatment Difference|1.04||||0.527|TWO_SIDED|90.0|0.94|1.15|||Mixed Models Analysis|||Week 12 Day 84||1.15|0.94|0.527
70965104|NCT02953639|141435702|SUPERIORITY||Treatment Difference|1.04||||0.636|TWO_SIDED|90.0|0.92|1.17|||Mixed Models Analysis|||Week 24 Day 168||1.17|0.92|0.636
70965105|NCT02953639|141435703|SUPERIORITY||Treatment Difference|-1.36||||0.323|TWO_SIDED|90.0|-3.63|0.91|||Mixed Models Analysis|||Week 12 Day 84||0.91|-3.63|0.323
70965106|NCT02953639|141435703|SUPERIORITY||Treatment Difference|-0.95||||0.579|TWO_SIDED|90.0|-3.77|1.88|||Mixed Models Analysis|||Week 24 Day 168||1.88|-3.77|0.579
70965107|NCT02953639|141435704|SUPERIORITY||Treatment Difference|-0.67||||0.493|TWO_SIDED|90.0|-2.27|0.94|||Mixed Models Analysis|||Week 12 Day 84||0.94|-2.27|0.493
70965108|NCT02953639|141435704|SUPERIORITY||Treatment Difference|-0.12||||0.926|TWO_SIDED|90.0|-2.32|2.07|||Mixed Models Analysis|||Week 24 Day 168||2.07|-2.32|0.926
70965109|NCT02953639|141435705|SUPERIORITY||Treatment Difference|-0.02||||0.839|TWO_SIDED|90.0|-0.22|0.17|||Mixed Models Analysis|||Week 12 Day 84||0.17|-0.22|0.839
70965110|NCT02953639|141435705|SUPERIORITY||Treatment Difference|-0.06||||0.625|TWO_SIDED|90.0|-0.27|0.15|||Mixed Models Analysis|||Week 24 Day 168||0.15|-0.27|0.625
70965111|NCT02953639|141435706|SUPERIORITY||Treatment Difference|-0.03||||0.865|TWO_SIDED|90.0|-0.28|0.23|||Mixed Models Analysis|||Week 12 Day 84||0.23|-0.28|0.865
70965112|NCT02953639|141435706|SUPERIORITY||Treatment Difference|-0.01||||0.964|TWO_SIDED|90.0|-0.31|0.29|||Mixed Models Analysis|||Week 24 Day 168||0.29|-0.31|0.964
70965113|NCT02953639|141435707|SUPERIORITY||Treatment Difference|3.27||||0.142|TWO_SIDED|90.0|-0.4|6.95|||Mixed Models Analysis|||Week 12 Day 84 (SQLS Cognition \& Vitality Score)||6.95|-0.40|0.142
70965114|NCT02953639|141435707|SUPERIORITY||Treatment Difference|-2.32||||0.416|TWO_SIDED|90.0|-7.04|2.4|||Mixed Models Analysis|||Week 24 Day 168 (SQLS Cognition \& Vitality Score)||2.40|-7.04|0.416
70965115|NCT02953639|141435707|SUPERIORITY||Treatment Difference|1.98||||0.394|TWO_SIDED|90.0|-1.86|5.83|||Mixed Models Analysis|||Week 12 Day 84 (SQLS Psychosocial Score)||5.83|-1.86|0.394
70965116|NCT02953639|141435707|SUPERIORITY||Treatment Difference|0.71||||0.776|TWO_SIDED|90.0|-3.44|4.87|||Mixed Models Analysis|||Week 24 Day 168 (SQLS Psychosocial Score)||4.87|-3.44|0.776
70965117|NCT02953639|141435707|SUPERIORITY||Treatment Difference|2.43||||0.254|TWO_SIDED|90.0|-1.09|5.94|||Mixed Models Analysis|||Week 12 Day 84 (SQLS Total Score)||5.94|-1.09|0.254
70965118|NCT02953639|141435707|SUPERIORITY||Treatment Difference|-0.57||||0.816|TWO_SIDED|90.0|-4.64|3.5|||Mixed Models Analysis|||Week 24 Day 168 (SQLS Total Score)||3.50|-4.64|0.816
70965119|NCT04196803|141435713|SUPERIORITY||||||<|0.05|||||||Regression, Linear|P value was calculated using general linear model adjusted for age, sex, and baseline level||||||<0.05
70965120|NCT04196803|141435714|SUPERIORITY||||||>|0.05|||||||Regression, Linear|P value was calculated using general linear model adjusted for age, sex, and baseline level||||||>0.05
70965121|NCT04196803|141435715|SUPERIORITY||||||>|0.05|||||||Regression, Linear|P value was calculated using general linear model adjusted for age, sex, and baseline level||||||>0.05
70965122|NCT04196803|141435716|SUPERIORITY||||||=|0.08|||||||Regression, Linear|P value was calculated using general linear model adjusted for age, sex, and baseline level||||||=0.08
70965123|NCT03349775|141435723|SUPERIORITY||Median Difference (Final Values)|-2.57|STANDARD_DEVIATION|5.14||0.35|TWO_SIDED|95.0|-8.32|3.18|||t-test, 2 sided|||||3.18|-8.32|0.35
70965124|NCT03349775|141435724|SUPERIORITY||Median Difference (Final Values)|1.13|STANDARD_DEVIATION|2.13||0.37|TWO_SIDED|95.0|-1.65|3.92|||t-test, 2 sided|||||3.92|-1.65|0.37
70965125|NCT01516970|141435726|SUPERIORITY_OR_OTHER|||||||0.2434||||||The discontinuation rates were compared with a statistical test (Cochran-Mantel-Haenszel \[CMH\]-Test) with p-value: 0.2434|Cochran-Mantel-Haenszel|||||||0.2434
70965126|NCT01516970|141435727|SUPERIORITY_OR_OTHER|||||||0.8839||||||The percentage of participants with TEAEs were compared with a statistical test (Fisher's Exact Test) with p-value: 0.8839.|Fisher Exact|||||||0.8839
70965127|NCT01756040|141435730|OTHER|||||||0.932||||||not adjusted for multiple comparisons. The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||We hypothesized that intestinal permeability as measured by urinary lactulose/rhamnose ratio would be higher in the lower gestational age (\<29 weeks) compared to the more mature infants (≥29 weeks gestation) at postnatal age 7-10 days.||||0.932
70965128|NCT01756040|141435731|OTHER|||||||0.316|||||||t-test, 2 sided|||We hypothesized that stool A1AT would be higher in infants with high IP as measured by urinary La/Rh compared to those with low IP.||||0.316
70965129|NCT01756040|141435732|OTHER|||||||0.011||||||The significance value was estimated using Bayesian goodness-of-fit p-value to assess the significance of the association of the relative abundance of Clostridiales and IP categories. P value \<0.05 was considered significant.|Bayesian goodness of fit|||||||0.011
70965130|NCT01756040|141435733|OTHER|||||||0.0023|||||||t-test, 2 sided|||We hypothesized that infants with normal barrier function (La/Rh ratio ≤0.05) would have been fed breastmilk for longer duration than infants with impaired barrier function (La/Rh\>0.05).||||0.0023
70965131|NCT01756040|141435734|OTHER|||||||1|||||||Chi-squared|||||||1.0
70965132|NCT01756040|141435735|OTHER|||||||0.461||||||A priori threshold \<0.05|Chi-squared|||||||0.461
70965133|NCT01756040|141435736|OTHER|||||||0.019|||||||t-test, 2 sided|||We hypothesized that infants with impaired barrier function as measured by high urinary La/Rh (\>0.05) ratio at 7-10 days of age would require longer time to reach full enteral feedings than infants with normal barrier function (La/Rh≤0.05)||||0.019
70965134|NCT01540825|141435740|SUPERIORITY_OR_OTHER||Slope|1.2472|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|1.1831|1.3112|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale. Standard Error of the mean is actually the Standard Error of the slope|This was non confirmatory testing (Single dose). Dose proportionality of BI 113608 (powder in bottle (PIB)) for Cmax was analysed.||1.3112|1.1831|
70965135|NCT01540825|141435742|SUPERIORITY_OR_OTHER||Slope|1.1626|STANDARD_ERROR_OF_MEAN|0.0215|||TWO_SIDED|95.0|1.1195|1.2057|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale. Standard Error of the mean is actually Standard Error of the slope|This was non confirmatory testing (Single dose). Dose proportionality of BI 113608 (PIB) for AUC 0- tz was analysed.||1.2057|1.1195|
70965136|NCT01540825|141435743|SUPERIORITY_OR_OTHER||Slope|1.151|STANDARD_ERROR_OF_MEAN|0.0215|||TWO_SIDED|95.0|1.108|1.1941|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale. Standard Error of the mean is actually Standard Error of the slope|This was non confirmatory testing (Single dose).Dose proportionality of BI 113608 (PIB) for AUC0-inf was analysed||1.1941|1.1080|
70965137|NCT00892177|141435750|SUPERIORITY_OR_OTHER_LEGACY||Maximum Tolerated Dose (mg)|100.0|||||TWO_SIDED|||||||||||||
70965138|NCT00892177|141435751|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.1||||0.22|TWO_SIDED|95.0|-0.052|0.262|||Chi-squared, Corrected||Difference in proportion|||0.262|-0.052|0.22
70965139|NCT00892177|141435753|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92||||0.7|TWO_SIDED|95.0|0.61|1.4|||Kaplan Meier|||||1.4|0.61|0.7
70965140|NCT00892177|141435754|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.14||||0.52|TWO_SIDED|95.0|0.76|1.7|||Kaplan Meier|||||1.7|0.76|0.52
70965141|NCT00892177|141435755|SUPERIORITY||Mean Difference (Final Values)|-0.223||||0.96|TWO_SIDED||||||Mixed Models Analysis||The estimate is the net difference between Arm A and Arm B total score using information from all cycles. A negative value means that Arm A has a lower quality of life and a positive value means Arm A has a higher reported quality of life.|||||0.96
70965142|NCT00892177|141435756|SUPERIORITY|||||||0.6325|||||||Fisher Exact|||||||0.6325
70965143|NCT02319668|141435787|SUPERIORITY_OR_OTHER||Least square (LS) Mean difference|0.2||||0.2965|TWO_SIDED|95.0|-0.18|0.58|||ANCOVA|ANCOVA with treatment as factor and baseline as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.58|-0.18|0.2965
70965144|NCT01338415|141435807|OTHER||Hazard Ratio (HR)|1.438|||||TWO_SIDED|95.0|0.47|4.399|||Regression, Cox|||Post-hoc analysis: Cox proportional hazard regression univariate model with treatment as covariate (treatment-only univariate model)||4.399|0.470|
70965145|NCT01338415|141435807|OTHER|||||||0.0526||||||p-value \<= 10% indicates that the covariate WHO FC at baseline is related to the time to PAH worsening|Regression, Cox|||Post-hoc analysis: Cox proportional hazard regression univariate model with WHO FC at baseline (FC III vs FC I/II) as covariate||||0.0526
70965146|NCT01338415|141435807|OTHER||Hazard Ratio (HR)|1.169||||||95.0|0.371|3.681|||Regression, Cox|||Post-hoc analysis: Treatment Hazard Ratio (HR) in the multivariate model with treatment and WHO FC at baseline as covariates||3.681|0.371|
70965147|NCT01338415|141435807|SUPERIORITY|||||||0.076||||||p-value \<= 10% indicates an improvement in model fit|log(e) likelihood ratio|||Test of improvement in model fit from the univariate to the multivariate model with WHO FC at baseline as covariate||||0.076
70965148|NCT01338415|141435808|OTHER||Hazard Ratio (HR)|1.935|||||TWO_SIDED|95.0|0.582|6.428|||Regression, Cox|||Post-hoc analysis: Cox proportional hazard regression univariate model with treatment as covariate (treatment-only univariate model)||6.428|0.582|
70965149|NCT01338415|141435808|OTHER|||||||0.0085|||||||Regression, Cox|p-value \<= 10% indicates that the covariate is related to the time to the time to death up to end-of-study||Post-hoc analysis: Cox proportional hazard regression univariate model with WHO FC at baseline (FC III vs FC I/II) as covariate||||0.0085
70965150|NCT01338415|141435808|OTHER||Hazard Ratio (HR)|1.487|||||TWO_SIDED|95.0|0.437|5.052|||Regression, Cox|||Post-hoc analysis: Treatment Hazard Ratio (HR) in the multivariate model with treatment and WHO FC at baseline as covariates||5.052|0.437|
70965151|NCT01338415|141435808|SUPERIORITY|||||||0.014|||||||log(e) likelihood ratio|p-value \<= 10% indicates an improvement in model fit||Test of the improvement in model fit from the univariate to the multivariate model with WHO FC at baseline as covariate||||0.014
70965152|NCT01970488|141435837|NON_INFERIORITY_OR_EQUIVALENCE|Clinical equivalence was evaluated by comparing the 2-sided 95% confidence interval (CI) of the difference of PASI percent improvement from baseline to Week 16 between ABP 501 and adalimumab with an equivalence margin of ± 15.|Least Squares (LS) Mean Difference|-2.18|||||TWO_SIDED|95.0|-7.39|3.02||||||||3.02|-7.39|
70965153|NCT00789750|141435868|OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.084|<|0.001|TWO_SIDED|95.0|-0.49|-0.16|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-0.16|-0.49|<0.001
70965154|NCT00789750|141435869|OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.037|<|0.001|TWO_SIDED|95.0|-0.24|-0.1|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-0.10|-0.24|<0.001
70965155|NCT00789750|141435870|OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.056||0.0002|TWO_SIDED|95.0|-0.32|-0.1|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-0.10|-0.32|0.0002
70965156|NCT00789750|141435871|OTHER||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.077|<|0.001|TWO_SIDED|95.0|-0.51|-0.2|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-0.20|-0.51|<0.001
70965157|NCT00789750|141435872|OTHER|||||||0.012|||||||Cochran-Mantel-Haenszel|||||||0.012
70965158|NCT00789750|141435873|OTHER||Mean Difference (Final Values)|-14.7|STANDARD_ERROR_OF_MEAN|3.68|<|0.0001|TWO_SIDED|95.0|-21.93|-7.49|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-7.49|-21.93|<0.0001
70965159|NCT00789750|141435874|OTHER|||||||0.0003|||||||Cochran-Mantel-Haenszel|||||||0.0003
70965160|NCT00789750|141435875|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
70965161|NCT00789750|141435876|OTHER|||||||0.132|||||||Cochran-Mantel-Haenszel|||||||0.132
70965162|NCT00789750|141435877|OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
70965163|NCT00789750|141435878|OTHER||Mean Difference (Final Values)|-16.4|STANDARD_ERROR_OF_MEAN|2.15|<|0.001|TWO_SIDED|95.0|-20.62|-12.18|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-12.18|-20.62|<0.001
70965164|NCT00789750|141435879|OTHER||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|1.31||0.1652|TWO_SIDED|95.0|-0.75|4.39|||ANCOVA|||Treatment difference = Colesevelam - Placebo||4.39|-0.75|0.1652
70965165|NCT00789750|141435880|OTHER||Mean Difference (Final Values)|-9.8|STANDARD_ERROR_OF_MEAN|1.85|<|0.0001|TWO_SIDED|95.0|-13.44|-6.16|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-6.16|-13.44|<0.0001
70965166|NCT00789750|141435881|OTHER||Median Difference (Final Values)|11.3|STANDARD_ERROR_OF_MEAN|67.01||0.0004|TWO_SIDED|95.0|5.3|17.5|||ANCOVA||The treatment difference and its 95% confidence interval are estimated using the Hodges-Lehmann estimator and Moses method. The parameter dispersion Type is actually IQR of the Median Difference.|Treatment difference = Colesevelam - Placebo||17.5|5.3|0.0004
70965167|NCT00789750|141435882|OTHER||Mean Difference (Final Values)|3.4|STANDARD_ERROR_OF_MEAN|0.93||0.0003|TWO_SIDED|95.0|1.58|5.23|||ANCOVA|||Treatment difference = Colesevelam - Placebo||5.23|1.58|0.0003
70965168|NCT00789750|141435883|OTHER||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|1.52|<|0.0001|TWO_SIDED|95.0|-11.75|-5.78|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-5.78|-11.75|<0.0001
70965169|NCT00789750|141435884|OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.77||0.7286|TWO_SIDED|95.0|-4.1|2.9|||ANCOVA|||Treatment difference = Colesevelam - Placebo||2.9|-4.1|0.7286
70965170|NCT00789750|141435885|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0653|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||Treatment difference = Colesevelam - Placebo||0.0|-0.4|0.0653
70965171|NCT00789750|141435886|OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.73||0.8862|TWO_SIDED|95.0|-1.5|1.3|||ANCOVA|||Treatment difference = Colesevelam - Placebo||1.3|-1.5|0.8862
70965172|NCT03933397|141435929|SUPERIORITY|||||||0.909|||||||Regression, Linear|||||||0.909
70965173|NCT00953719|141435934|NON_INFERIORITY_OR_EQUIVALENCE|The prospectively planned primary endpoint analysis was a non-inferiority test of covariate adjusted 24 month or later Harris Hip score means with a 5 point non-inferiority margin. A prospective power analysis with an anticipated Harris Hip score standard deviation of 10.08 (for both treatment groups) indicated that sample sizes of 134 and 67 would provide approximately 95% statistical power for this non-inferiority test with a type 1 error rate of 5%.|Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|1.24|<|0.001|ONE_SIDED|95.0|-1.4||||ANCOVA||||||-1.40|<0.001
70965174|NCT00953719|141435940|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.079||||0.952||95.0|||||Mixed Models Analysis|SAS PROC MIXED was used with an ante-dependence covariance structure.||A repeated measurements longitudinal model of Harris Hip scores was carried out to compare Harris Hip results between treatment groups across time.||||0.952
70965175|NCT01478360|141435944|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.166||||0.5392|TWO_SIDED|90.0|-0.617|0.285|||Mixed Models Analysis|||||0.285|-0.617|0.5392
70965176|NCT04223791|141435945|NON_INFERIORITY|Non-inferiority is concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI for the difference in the percentage of participants with HIV-1 RNA ≥50 copies/mL (DOR/ISL-BIC/FTC/TAF) is less than 4 percentage points.|Estimated difference|0.31|||<|0.001|TWO_SIDED|95.0|-1.19|1.96||p-value for the treatment differences in percent response were calculated using the unstratified Miettinen and Nurminen method.|Unstratified Miettinen and Nurminen||Treatment difference for DOR/ISL group-BIC/FTC/TAF group.|||1.96|-1.19|<.001
70965177|NCT04223791|141435946|OTHER|Difference between treatment groups|Difference in % (DOR/ISL- BIC/FTC/TAF)|-3.5|||||TWO_SIDED|95.0|-10.4|3.4|||||Based on Miettinen and Nurminen method|||3.4|-10.4|
70965178|NCT04223791|141435947|OTHER|Difference between treatment groups|Difference in % (DOR/ISL- BIC/FTC/TAF)|-0.02|||||TWO_SIDED|95.0|-2.7|2.6|||||Based on Miettinen and Nurminen method|||2.6|-2.7|
70965179|NCT04223791|141435960|SUPERIORITY||Treatment Difference|-0.3||||0.392|TWO_SIDED|95.0|-0.99|0.39|||ANCOVA|Model included terms for baseline weight, sex, race, and treatment.|Treatment difference for DOR/ISL group-BIC/FTC/TAF group.|||0.39|-0.99|0.392
70965180|NCT00395863|141435982|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Reader 1|wilcoxon signed-rank test|||||||< 0.0001
70965181|NCT00395863|141435982|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Reader 2|wilcoxon signed-rank test|||||||<0.0001
70965182|NCT00395863|141435982|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Reader 3|wilcoxon signed-rank test|||||||< 0.0001
70965183|NCT00395863|141435983|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||||||Reader 1|wilcoxon signed-rank test|||||||0.0001
70965184|NCT00395863|141435983|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||||||Reader 2|wilcoxon signed-rank test|||||||0.001
70965185|NCT00395863|141435983|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||||||Reader 3|wilcoxon signed-rank test|||||||0.0002
70965186|NCT00395863|141435984|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Reader 1|wilcoxon signed-rank test|||||||<0.0001
70965187|NCT00395863|141435984|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Reader 2|wilcoxon signed-rank test|||||||<0.0001
70965188|NCT00395863|141435984|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Reader 3|wilcoxon signed-rank test|||||||<0.0001
70965189|NCT00395863|141435985|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_DEVIATION|0.22|<|0.0001||95.0|0.14|0.3||Mean difference of MultiHance minus Magnevist for change from baseline|t-test, 2 sided|||||0.30|0.14|<0.0001
70965190|NCT00395863|141435986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|0.2|<|0.0001||95.0|0.22|0.38||Mean difference of Multihance minus Magnevist for change from baseline|t-test, 2 sided|||||0.38|0.22|<0.0001
70965191|NCT00395863|141435987|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_DEVIATION|0.19|<|0.0001||95.0|0.18|0.33||Mean difference of Multihance minus Magnevist for change from baseline|t-test, 2 sided|||||0.33|0.18|<0.0001
70965192|NCT00395863|141435988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|40.99|STANDARD_DEVIATION|59.78||0.0062||95.0|20.72|61.26||Mean difference of Multihance minus Magnevist for change from baseline|t-test, 2 sided|||||61.26|20.72|0.0062
70965193|NCT00395863|141435989|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|30.95|STANDARD_DEVIATION|48.64||0.0027||95.0|16.57|45.33||Mean difference of Multihance minus Magnevist for change from baseline|t-test, 2 sided|||||45.33|16.57|0.0027
70965194|NCT00395863|141435990|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|25.04|STANDARD_DEVIATION|37.37||0.02||95.0|12.41|37.67||Mean difference of Multihance minus Magnevist for change from baseline|t-test, 2 sided|||||37.67|12.41|0.02
70965195|NCT00395863|141435991|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|32.77|STANDARD_DEVIATION|48.51||0.0019||95.0|14.28|51.25||Mean difference of Multihance minus Magnevist|t-test, 2 sided|||||51.25|14.28|0.0019
70965196|NCT00395863|141435992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|33.61|STANDARD_DEVIATION|43.16||0.0008||95.0|16.75|50.47||Mean difference of Multihance minus Magnevist|t-test, 2 sided|||||50.47|16.75|0.0008
70965197|NCT00395863|141435993|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|33.72|STANDARD_DEVIATION|48.5||0.0026||95.0|14.63|52.81||Mean difference of Multihance minus Magnevist|t-test, 2 sided|||||52.81|14.63|0.0026
70965198|NCT05097716|141435995|EQUIVALENCE|90% CI|ratio of adjusted geometric means|103.01|||||TWO_SIDED|90.0|96.66|109.77|||||The comparison was Test vs. Reference (Ritlecitinib + Tolbutamide vs. Tolbutamide).|||109.77|96.66|
70965199|NCT05097716|141435996|EQUIVALENCE|90% CI|ratio of adjusted geometric means|99.05|||||TWO_SIDED|90.0|92.01|106.62|||||The comparison was Test vs. Reference (Ritlecitinib + Tolbutamide vs. Tolbutamide).|||106.62|92.01|
70965200|NCT01286454|141435998|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|111.23|||||TWO_SIDED|90.0|102.69|120.47||||||Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg IR-BIC Fasted was test.||120.47|102.69|
70965201|NCT01286454|141435998|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|103.07|||||TWO_SIDED|90.0|95.16|111.64||||||Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fasted was test.||111.64|95.16|
70965202|NCT01286454|141435998|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|70.36|||||TWO_SIDED|90.0|64.52|76.74||||||Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 15% ER-BIC Fasted was test.||76.74|64.52|
70965203|NCT01286454|141435998|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|113.55|||||TWO_SIDED|90.0|105.91|121.74||||||Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg 10% ER-BIC Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fed was test.||121.74|105.91|
70965204|NCT01286454|141435999|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|112.8|||||TWO_SIDED|90.0|103.85|122.52||||||Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg IR-BIC Fasted was test.||122.52|103.85|
70965205|NCT01286454|141435999|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|103.71|||||TWO_SIDED|90.0|95.48|112.65||||||Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fasted was test.||112.65|95.48|
70965206|NCT01286454|141435999|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|66.87|||||TWO_SIDED|90.0|61.56|72.63||||||Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 15% ER-BIC Fasted was test.||72.63|61.56|
70965207|NCT01286454|141435999|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|28.34|||||TWO_SIDED|90.0|26.09|30.78||||||Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 20% ER-BIC Fasted was test.||30.78|26.09|
70965208|NCT01286454|141435999|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|114.7|||||TWO_SIDED|90.0|106.99|122.97||||||Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg 10% ER-BIC Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fed was test.||122.97|106.99|
70965209|NCT01286454|141436000|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|259.4|||||TWO_SIDED|90.0|231.48|290.7||||||Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg IR-BIC Fasted was test.||290.70|231.48|
70965210|NCT01286454|141436000|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|134.83|||||TWO_SIDED|90.0|120.31|151.09||||||Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fasted was test.||151.09|120.31|
70965211|NCT01286454|141436000|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|48.58|||||TWO_SIDED|90.0|43.35|54.44||||||Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 15% ER-BIC Fasted was test.||54.44|43.35|
70965212|NCT01286454|141436000|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|14.38|||||TWO_SIDED|90.0|12.83|16.11||||||Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 20% ER-BIC Fasted was test.||16.11|12.83|
70965213|NCT01286454|141436000|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|171.06|||||TWO_SIDED|90.0|115.82|187.78||||||Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg 10% ER-BIC Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fed was test.||187.78|115.82|
70965214|NCT02367066|141436003|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.02||0.02|TWO_SIDED|80.0|0.9|0.98||1-sided|Mixed Models Analysis|||||0.98|0.90|0.02
70965215|NCT02367066|141436004|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.96|STANDARD_ERROR_OF_MEAN|0.03||0.06|TWO_SIDED|80.0|0.92|0.99||1-sided|Mixed Models Analysis|||||0.99|0.92|0.06
70965216|NCT02367066|141436005|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.99|STANDARD_ERROR_OF_MEAN|0.03||0.41|TWO_SIDED|80.0|0.96|1.03||1-sided|Mixed Models Analysis|||||1.03|0.96|0.41
70965217|NCT02367066|141436006|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.92|STANDARD_ERROR_OF_MEAN|0.05||0.06|TWO_SIDED|80.0|0.85|0.99||1-sided|Mixed Models Analysis|||||0.99|0.85|0.06
70965218|NCT02367066|141436007|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|1.06|STANDARD_ERROR_OF_MEAN|0.04||0.18|TWO_SIDED|80.0|0.99|1.13||1-sided|Mixed Models Analysis|||||1.13|0.99|0.18
70965219|NCT02367066|141436008|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.93|STANDARD_ERROR_OF_MEAN|0.04||0.04|TWO_SIDED|80.0|0.89|0.98||1-sided|Mixed Models Analysis|||||0.98|0.89|0.04
70965220|NCT02367066|141436010|SUPERIORITY_OR_OTHER||Geometric LS MEan Ratio|1.0|STANDARD_ERROR_OF_MEAN|0.05||0.37|TWO_SIDED|80.0|0.91|1.06||1-sided|Mixed Models Analysis|||||1.06|0.91|0.37
70965221|NCT02367066|141436012|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.01||0.06|TWO_SIDED|80.0|1.0|1.04||1-sided|Mixed Models Analysis|||||1.04|1.00|0.06
70965222|NCT02367066|141436013|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.01||0.45|TWO_SIDED|90.0|-0.01|0.03||2-sided|Mixed Models Analysis|||||0.03|-0.01|0.45
70965223|NCT04556136|141436032|NON_INFERIORITY|This non-inferiority study was designed to demonstrate the ability of the phototherapy kiosk to safely administer UVB radiation to participants with varying levels of 25(OH)D and achieve comparable levels of serum 25(OH)D in a similar population of adults randomized to receive RDA of 600 IU vitamin D oral supplementation daily. It is important to evaluate device equivalence to standard of care in the maintenance of sufficient levels of vitamin D in adults 18 - 70 years old.||||||0.01||||||Threshold for significance \<0.05|Wilcoxon (Mann-Whitney)|Effect sizes for significant differences were included as eta squared (ŋ2) values.||The intent-to-treat analysis plan was carried out with all available subject data points. No interim analysis was performed. Exploratory data analyses were conducted on serum vitamin D levels of participants assigned to either the oral supplementation or kiosk group. Analysis was restricted to participants with valid baseline serum vitamin D data and at least one follow-up blood draw. The Shapiro-Wilk test was used to assess the normality of the data distribution.||||0.01
70965224|NCT02289352|141436048|EQUIVALENCE|If the 90% confidence interval for the absolute difference between the proportion of patients considered a treatment success (at least a 2-grade improvement on both CEA and PSA over 6 hours+/-10 minutes) in the Test and Reference groups is contained within the range \[-20%, +20%\], then bioequivalence of the Test product to the Reference product is considered to have been demonstrated.|Mean Difference (Net)|-0.58|||||TWO_SIDED|90.0|-6.49|5.33||||||||5.33|-6.49|
70965225|NCT02289352|141436048|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70965226|NCT02289352|141436048|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70965227|NCT02289352|141436049|EQUIVALENCE|"The secondary efficacy variable is the proportion of patients with a clinical response of treatment success on Day 1.~If the 90% confidence interval for the absolute difference between the proportion of patients considered a treatment success (at least a 2-grade improvement on both the CEA and PSA over 6 hours+/-10 minutes) in the Test and Reference groups is contained within the range \[-20%, 20%\], then bioequivalence of the Test to Reference product is considered to have been demonstrated."|Mean Difference (Net)|6.94|||||TWO_SIDED|90.0|-1.54|15.41||||||||15.41|-1.54|
70965228|NCT02289352|141436049|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70965229|NCT02289352|141436049|SUPERIORITY|||||||0.0045|||||||t-test, 2 sided|||||||0.0045
70965230|NCT01177384|141436055|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.62|||<|0.001|TWO_SIDED|95.0|-0.79|-0.44||The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (on acarbose monotherapy, or on acarbose in combination with other AHA(s)) and a covariate for baseline A1C.|ANCOVA|||||-0.44|-0.79|<.001
70965231|NCT01177384|141436056|SUPERIORITY_OR_OTHER||Difference in least squares mean|-14.4|||<|0.001|TWO_SIDED|95.0|-21.8|-7.0||The ANCOVA model included terms for treatment and prior AHA therapy status (on acarbose monotherapy, or on acarbose in combination with other AHA(s)) and a covariate for baseline FPG.|ANCOVA|||||-7.0|-21.8|<.001
70965232|NCT01849497|141436059|SUPERIORITY_OR_OTHER||Treatment Difference|-6.8|||||TWO_SIDED|95.0|-16.3|2.0||||||||2.0|-16.3|
70965233|NCT01849497|141436060|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-3.7|STANDARD_ERROR_OF_MEAN|3.38|||TWO_SIDED|95.0|-10.38|2.99||||||||2.99|-10.38|
70965234|NCT00911625|141436098|SUPERIORITY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|9.502||0.958|TWO_SIDED|95.0|-19.341|18.341|||t-test, 2 sided|||The null hypothesis is that there is no difference between the two treatment cohorts on their average blood glucose level||18.341|-19.341|.958
70965235|NCT00911625|141436099|SUPERIORITY||Odds Ratio (OR)|0.438||||0.0828|TWO_SIDED|95.0|0.172|1.114|||Regression, Logistic|||The null hypothesis is that there is no difference in the odds of experiencing at least one blood glucose level below 70 mg/dL between the two treatment cohorts.||1.114|0.172|.0828
70965236|NCT00529451|141436103|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 2.25 mm Hg|Mean Difference (Final Values)|-2.44|||||TWO_SIDED|95.0|-3.63|-1.25||||||||-1.25|-3.63|
70965237|NCT00529451|141436104|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 2.25 mm Hg|Mean Difference (Final Values)|-0.86|||||TWO_SIDED|95.0|-2.06|0.34||||||||0.34|-2.06|
70965238|NCT00529451|141436105|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 2.25 mm Hg|Mean Difference (Final Values)|-1.48|||||TWO_SIDED|95.0|-2.67|-0.28||||||||-0.28|-2.67|
70965239|NCT02101515|141436106|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.45|||||TWO_SIDED|95.0|0.22|0.93||||||||0.93|0.22|
70965240|NCT02101515|141436108|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.41|||||TWO_SIDED|95.0|0.67|8.4||||||||8.40|0.67|
70965241|NCT02101515|141436109|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.41|1.45||||||||1.45|0.41|
70965242|NCT02101515|141436110|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.71|||||TWO_SIDED|95.0|1.3|5.62||||||||5.62|1.30|
70965243|NCT02101515|141436111|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.06|13.92||||||||13.92|0.06|
70965244|NCT02101515|141436113|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|5.41|||||TWO_SIDED|95.0|0.68|42.9||||||||42.90|0.68|
70965245|NCT02101515|141436115|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.8|||||TWO_SIDED|95.0|0.46|1.54||||||||1.54|0.46|
70965246|NCT02101515|141436116|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.39|1.49||||||||1.49|0.39|
70965247|NCT02101515|141436118|SUPERIORITY_OR_OTHER|||||||0.6|||||||t-test, 2 sided|||||||0.6
70965248|NCT02101515|141436122|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3|||||TWO_SIDED|95.0|0.03|2.77||||||||2.77|0.03|
70965249|NCT01289821|141436123|SUPERIORITY_OR_OTHER||Percentage of Participants|43.9||||0.36|TWO_SIDED|80.0|33.19|55.09|||One-sample exact binomial test|||"Null hypothesis: True probability p of objective tumor response does not exceed p0, p0=0.4. H0: p\<=0.4 One-sided type I error probability of alpha=10%"||55.09|33.19|0.36
70965250|NCT03591354|141436129|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70965251|NCT02901574|141436202|SUPERIORITY||Mean Difference (Final Values)|3.87||||0.24|TWO_SIDED|95.0|-2.55|10.3||Threshold for significance is two-sided alpha of 0.05.|Mixed Models Analysis|||||10.30|-2.55|0.24
70965252|NCT01010633|141436217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.3|||<|0.001|TWO_SIDED|95.0|5.7|22.9|||Chi-squared|||||22.9|5.7|<0.001
70965253|NCT01010633|141436219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.0|||<|0.001|TWO_SIDED|95.0|21.4|40.7|||Chi-squared|||||40.7|21.4|<0.001
70965254|NCT04666350|141436220|OTHER||Combined Difference in Prevalence|-0.025||||0.711|TWO_SIDED|95.0|-0.16|0.109|||Other|The p-value is estimated assuming the combined difference over the square root of the weighted variance follows a normal distribution.||Comparison of DSFA Day 2 versus Day 1. For each participant, the difference in oocyte prevalence using DSFA on Day 1 versus Day 2 was estimated. To evaluate the hypothesis that the average mean difference in the prevalence between two assays within the same subject is zero, combined estimates (weighted mean and variance) were obtained using as weight the inverse of the variance of each paired difference obtained from the Agresti and Caffo method.||0.109|-0.160|0.711
70965255|NCT04666350|141436220|OTHER||Combined Difference in Prevalence|-0.016||||0.795|TWO_SIDED|95.0|-0.139|0.107|||Other|The p-value is estimated assuming the combined difference over the square root of the weighted variance follows a normal distribution.||Comparison of DMFA Day 2 versus Day 1. For each participant, the difference in oocyte prevalence using DMFA on Day 1 versus Day 2 was estimated. To evaluate the hypothesis that the average mean difference in the prevalence between two assays within the same subject is zero, combined estimates (weighted mean and variance) were obtained using as weight the inverse of the variance of each paired difference obtained from the Agresti and Caffo method.||0.107|-0.139|0.795
70965256|NCT04666350|141436221|OTHER||Relative Rate|0.38||||0.019|TWO_SIDED|95.0|0.21|0.7||Difference between days was evaluated using zero inflated Poisson regression models having as outcome the number of oocysts, as offset the number of surviving mosquitoes, and adjusted by subject.|Poisson Regression|||Comparison of DSFA Day 2 versus Day 1.||0.70|0.21|0.019
70965257|NCT04666350|141436221|OTHER||Relative Rate|0.23||||0.003|TWO_SIDED|95.0|0.11|0.45||Difference between days was evaluated using zero inflated Poisson regression models having as outcome the number of oocysts, as offset the number of surviving mosquitoes, and adjusted by subject.|Poisson Regression|||Comparison of DMFA Day 2 versus Day 1.||0.45|0.11|0.003
70965258|NCT04666350|141436222|OTHER||Combined Difference in Prevalence|-0.023||||0.75|TWO_SIDED|95.0|-0.164|0.118|||Other|The p-value is estimated assuming the combined difference over the square root of the weighted variance follows a normal distribution.||Comparison of DSFA Day 2 versus Day 1. For each participant, the difference in sporozoite prevalence using DSFA on Day 1 versus Day 2 was estimated. To evaluate the hypothesis that the average mean difference in the prevalence between two assays within the same subject is zero, combined estimates (weighted mean and variance) were obtained using as weight the inverse of the variance of each paired difference obtained from the Agresti and Caffo method.||0.118|-0.164|0.750
70965259|NCT04666350|141436222|OTHER||Combined Difference in Prevalence|-0.031||||0.681|TWO_SIDED|95.0|-0.178|0.117|||Other|The p-value is estimated assuming the combined difference over the square root of the weighted variance follows a normal distribution.||Comparison of DMFA Day 2 versus Day 1. For each participant, the difference in sporozoite prevalence using DMFA on Day 1 versus Day 2 was estimated. To evaluate the hypothesis that the average mean difference in the prevalence between two assays within the same subject is zero, combined estimates (weighted mean and variance) were obtained using as weight the inverse of the variance of each paired difference obtained from the Agresti and Caffo method.||0.117|-0.178|0.681
70965260|NCT00097773|141436224|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.86|TWO_SIDED|95.0|0.54|1.66||There was no significant interaction with ciprofloxacin in this analysis.|Regression, Cox||risk of exacerbation comparing cycled therapy to culture-based therapy|The primary analysis compared the pooled Cycled Therapy group (n=152) vs. the Pooled culture-based therapy group (n=152). The null hypothesis was no difference between groups in the risk of pulmonary exacerbation requiring IV antibiotics or hospitalization. Assuming a total sample size of 300 (150 per group), the study provided 80% power to detect at least a 40% reduction in the risk of exacerbation in the cycled group as compared to the culture-based group at the two-sided alpha level of 5%.||1.66|0.54|0.86
70965261|NCT00097773|141436224|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||0.2|TWO_SIDED|95.0|0.82|2.54|||Regression, Cox||risk of exacerbation comparing oral cipro to oral placebo|A secondary comparison was between the pooled oral cipro (n=152)and pooled placebo groups (n=152. Null hypothesis was no difference between groups.||2.54|0.82|0.20
70965262|NCT00097773|141436225|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.28||95.0|0.49|1.23|||Regression, Logistic|No interaction with ciprofloxacin usage was observed.|odds of a positive culture comparing cycled therapy to culture-based therapy|Null hypothesis is that there is no difference between pooled cycled and culture-based treatment groups in the odds of a Pa positive culture over the 18 month study.||1.23|0.49|0.28
70965263|NCT00097773|141436225|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.67|TWO_SIDED|95.0|0.71|1.71|||Regression, Logistic||odds of a positive culture comparing the cipro group to the placebo group|Null hypothesis is that there is no difference between pooled cipro and placebo treatment groups in the odds of a Pa positive culture over the 18 month study.||1.71|0.71|0.67
70965264|NCT00097773|141436226|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.18|TWO_SIDED|95.0|0.58|1.11|||Regression, Cox|No interaction with ciprofloxacin usage was observed.|Hazard ratio comparing cycled to culture based therapy|The analysis compared the pooled Cycled Therapy group (n=152) vs. the Pooled culture-based therapy group (n=152). The null hypothesis was no difference between groups in the risk of pulmonary exacerbation.||1.11|0.58|0.18
70965265|NCT00097773|141436226|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.12|TWO_SIDED|95.0|0.94|1.78|||Regression, Cox||Hazard ratio comparing cipro to placebo.|This analysis was between the pooled oral cipro (n=152)and pooled placebo groups (n=152. Null hypothesis was no difference between groups.||1.78|0.94|0.12
70965266|NCT00698932|141436238|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001||95.0|-0.65|-0.34|||ANCOVA|\*adjusted for baseline HbA1c||||-0.34|-0.65|<0.0001
70965267|NCT00698932|141436239|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.73|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001||95.0|-1.06|-0.39|||ANCOVA|\*adjusted for baseline FPG||||-0.39|-1.06|<0.0001
70965268|NCT00698932|141436240|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.12|STANDARD_ERROR_OF_MEAN|3.053|<|0.0001||95.0|-19.12|-7.13|||ANCOVA|\*adjusted for baseline FPG||||-7.13|-19.12|<0.0001
70965269|NCT00698932|141436241|SUPERIORITY_OR_OTHER||Median Difference (Net)|-182.0|STANDARD_ERROR_OF_MEAN|54.4||0.001||95.0|-289.0|-74.0|||ANCOVA|\*adjusted for baseline PPG AUC||||-74|-289|0.001
70965270|NCT00698932|141436242|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3280.0|STANDARD_ERROR_OF_MEAN|980.0||0.001||95.0|-5214.0|-1345.0|||ANCOVA|\*adjusted for baseline PPG AUC||||-1345|-5214|0.001
70965271|NCT00698932|141436243|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.0|||<|0.0001||95.0|8.9|24.9|||ANCOVA|||||24.9|8.9|<0.0001
70965272|NCT02243865|141436339|SUPERIORITY|||||||0.6938|||||||ANCOVA|In the analyses the baseline value was used as a covariate in order to adjust for initial differences at treatment start.||||||0.6938
70965273|NCT02243865|141436340|SUPERIORITY|||||||0.6557|||||||ANCOVA|In the analyses the baseline value was used as a covariate in order to adjust for initial differences at treatment start.||Null hypothesis: There is no difference between the active treatment and placebo groups in change from baseline in number of migraine days during the 1st month of the three month post treatment investigation duration||||0.6557
70965274|NCT02243865|141436340|SUPERIORITY|||||||0.515|||||||ANCOVA|In the analyses the baseline value was used as a covariate in order to adjust for initial differences at treatment start.||Null hypothesis: There is no difference between the active treatment and placebo groups in change from baseline in number of migraine days during the 2nd month of the three month post treatment investigation duration||||0.515
70965275|NCT02243865|141436340|SUPERIORITY|||||||0.3256|||||||ANCOVA|In the analyses the baseline value was used as a covariate in order to adjust for initial differences at treatment start.||Null hypothesis: There is no difference between the active treatment and placebo groups in change from baseline in number of migraine days during the 3rd month of the three month post treatment investigation duration||||0.3256
70965276|NCT02243865|141436340|SUPERIORITY|||||||0.4086|||||||ANCOVA|In the analyses the baseline value was used as a covariate in order to adjust for initial differences at treatment start.||Null hypothesis: There is no difference between the active treatment and placebo groups in change from baseline in number of migraine days during the final four weeks of the three month post treatment investigation duration.||||0.4086
70965277|NCT03044249|141436359|SUPERIORITY||Response Ratio|4.0||||0.48|TWO_SIDED|90.0|-18.0|25.0|||Fisher Exact|||||25|-18|0.48
70965278|NCT03044249|141436361|SUPERIORITY||Mean Difference (Final Values)|-5.28||||0.14|TWO_SIDED|90.0|-11.16|0.61|||Mixed Models Analysis|||||0.61|-11.16|0.14
70965279|NCT03044249|141436362|SUPERIORITY||Mean Difference (Final Values)|-1.58||||0.37|TWO_SIDED|90.0|-4.47|1.31|||Mixed Models Analysis|||||1.31|-4.47|0.37
70965280|NCT03044249|141436366|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.94|TWO_SIDED|90.0|-2.0|1.84|||Mixed Models Analysis|||||1.84|-2.00|0.94
70965281|NCT01368042|141436375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.7|STANDARD_DEVIATION|32.9||0.03|||||||Wilcoxon signed rank test-paired samples||n=234 (paired samples)|||||0.03
70965282|NCT01368042|141436376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.3|STANDARD_DEVIATION|57.2||0.05|||||||Wilcoxon signed rank test-paired samples||n=231 (paired samples)|||||0.05
70965283|NCT01368042|141436377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.8|STANDARD_DEVIATION|56.4||0.003|||||||Wilcoxon signed rank test-paired samples||n=231 (paired samples)|||||0.003
70965284|NCT01368042|141436378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.5|STANDARD_DEVIATION|30.5|<|0.001|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||<0.001
70965285|NCT01368042|141436379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.4|STANDARD_DEVIATION|27.2|<|0.001|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||<0.001
70965286|NCT01368042|141436380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.3|STANDARD_DEVIATION|35.3|<|0.001|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||<0.001
70965287|NCT01368042|141436381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.7|STANDARD_DEVIATION|34.8|<|0.001|||||||Wilcoxon signed rank test-paired samples||n=234 (paired samples)|||||<0.001
70965288|NCT01368042|141436382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|20.9||0.38|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||0.38
70965289|NCT01368042|141436383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.0|STANDARD_DEVIATION|32.0|<|0.001|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||<0.001
70965290|NCT01368042|141436384|SUPERIORITY_OR_OTHER|||||||0.03|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Physical functioning scale||||0.03
70965291|NCT01368042|141436384|SUPERIORITY_OR_OTHER|||||||0.02|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Role functioning due to physical health scale||||0.02
70965292|NCT01368042|141436384|SUPERIORITY_OR_OTHER|||||||0.01|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Role functioning due to emotional problems scale||||0.01
70965293|NCT01368042|141436384|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Energy/fatigue scale||||<0.001
70965294|NCT01368042|141436384|SUPERIORITY_OR_OTHER|||||||0.002|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Emotional well-being scale||||0.002
70965295|NCT01368042|141436384|SUPERIORITY_OR_OTHER|||||||0.002|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Social functioning scale||||0.002
70965296|NCT01368042|141436384|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Bodily pain scale||||<0.001
70965297|NCT01368042|141436384|SUPERIORITY_OR_OTHER|||||||0.56|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||General health perceptions scale||||0.56
70965298|NCT01368042|141436385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|STANDARD_DEVIATION|41.6||0.001|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||0.001
70965299|NCT01368042|141436386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|1.4||0.03|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||0.03
70965300|NCT01368042|141436387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|0.9||0.06|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||0.06
70965301|NCT01368042|141436388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|1.7||0.84|||||||Wilcoxon signed rank test-paired samples||n=234 (paired samples)|||||0.84
70965302|NCT01368042|141436389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|16.5||0.67|||||||Wilcoxon signed rank test-paired samples||n=234 (paired samples)|||||0.67
70965303|NCT01368042|141436390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.4|STANDARD_DEVIATION|324.8||0.02|||||||Wilcoxon signed rank test-paired samples||n= 215 (paired samples)|||||0.02
70965304|NCT01368042|141436391|SUPERIORITY_OR_OTHER|||||||0.12|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||||||0.12
70965305|NCT01621542|141436393|OTHER|None specified||||||||||||||||The MTD could not be established for this study as no DLTs occurred at doses up to and including 27.0 mg|The MTD could not be established for this study as no DLTs occurred at doses up to and including 27.0 mg|||
70965306|NCT00955279|141436396|SUPERIORITY_OR_OTHER|||||||0.543|||||||ANCOVA|||||||0.543
70965307|NCT00955279|141436396|SUPERIORITY_OR_OTHER|||||||0.126|||||||ANCOVA|||||||0.126
70965308|NCT00955279|141436397|SUPERIORITY_OR_OTHER|||||||0.896|||||||Linear Contrasts Test|||||||0.896
70965309|NCT00955279|141436397|SUPERIORITY_OR_OTHER|||||||0.063|||||||Linear Contrasts Test|||||||0.063
70965310|NCT00955279|141436398|SUPERIORITY_OR_OTHER|||||||0.374|||||||Linear Contrasts Test|||||||0.374
70965311|NCT00955279|141436398|SUPERIORITY_OR_OTHER|||||||0.073|||||||Linear Contrasts Test|||||||0.073
70965312|NCT00955279|141436399|SUPERIORITY_OR_OTHER|||||||0.1931|||||||Fisher Exact|||||||0.1931
70965313|NCT00955279|141436399|SUPERIORITY_OR_OTHER|||||||0.2772|||||||Fisher Exact|||||||0.2772
70965314|NCT00955279|141436400|SUPERIORITY_OR_OTHER|||||||0.451|||||||Linear Contrast Test|||||||0.451
70965315|NCT00955279|141436400|SUPERIORITY_OR_OTHER|||||||0.546|||||||Linear Contrast Test|||||||0.546
70965316|NCT02632721|141436415|OTHER||Probability of DLT rate in [0.16, 0.33)|0.081|||||||||||||Posterior probability of the DLT rate lying in the interval \[0.16, 0.33) (target dosing) is reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.||||
70965317|NCT02632721|141436415|OTHER||Probability of DLT rate in [0.33, 1)|0.0|||||||||||||Posterior probability of the DLT rate lying in the interval \[0.33,1) (overdosing) is reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.||||
70965318|NCT02632721|141436415|OTHER||Probability of DLT rate in [0.16, 0.33)|0.028|||||||||||||Posterior probability of the DLT rate lying in the interval \[0.16, 0.33) (target dosing) is reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.||||
70965319|NCT02632721|141436415|OTHER||Posterior probability of the DLT rate ly|0.0|||||||||||||Posterior probability of the DLT rate lying in the interval \[0.33,1) (overdosing) is reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.||||
70965320|NCT02632721|141436415|OTHER||Probability of DLT rate in [0.16, 0.33)|0.012|||||||||||||Posterior probability of the DLT rate lying in the interval \[0.16, 0.33) (target dosing) is reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.||||
70965321|NCT02632721|141436415|OTHER||Probability of DLT rate in [0.33, 1)|0.0|||||||||||||Posterior probability of the DLT rate lying in the interval \[0.33,1) (overdosing) is reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.||||
70965322|NCT04207801|141436427|SUPERIORITY|||||||0.01|||||||Fisher Exact|||Efficacy of AUR101 was tested against placebo with respect to the primary endpoint (PASI75 response). A sample size of 25 in each of the three arms provided an 80% power with a one-sided Type I error of 0.05, if the true placebo response rate was 7% and the response rate on investigational arm(s) was 35%. The sample size was increased to 30 to account for \~ 15-20% dropouts over the study period.||||0.01
70965323|NCT02663271|141436438|SUPERIORITY|We used one-sample log rank test to compare to historical control.|Hazard Ratio (HR)|0.3|||<|0.001|TWO_SIDED||||||Log Rank|||||||<0.001
70965324|NCT00053703|141436444|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
70965325|NCT01500525|141436450|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.0|||<|0.05|ONE_SIDED|95.0|||||Regression, Cox|||||||<0.05
70965326|NCT04166383|141436452|OTHER|||||||0.1||||||P≤0.10 (alpha 0.1); power = 90% (beta 0.1)|Kaplan-Meier|||||||0.10
70965327|NCT03044886|141436459|SUPERIORITY|||||||0.576|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.576
70965328|NCT03044886|141436460|SUPERIORITY|||||||0.489|||||||ANOVA|||||||0.489
70965329|NCT03044886|141436461|SUPERIORITY|||||||0.042|||||||ANOVA|||||||0.042
70965330|NCT03044886|141436461|SUPERIORITY|||||||0.041|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine changes from 3 month to 6 month of all groups.||||0.041
70965331|NCT03044886|141436462|SUPERIORITY|||||||0.71|||||||ANCOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.710
70965332|NCT03044886|141436463|SUPERIORITY|||||||0.34|||||||ANOVA|||||||0.340
70965333|NCT03044886|141436464|SUPERIORITY|||||||0.048|||||||ANOVA|||||||0.048
70965334|NCT03044886|141436464|SUPERIORITY|||||||0.038|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine changes from 3 month to 6 month of all groups.||||0.038
70965335|NCT03044886|141436465|SUPERIORITY|||||||0.521|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.521
70965336|NCT03044886|141436466|SUPERIORITY|||||||0.742|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.742
70965337|NCT03044886|141436467|SUPERIORITY||||||<|0.05|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||<0.05
70965338|NCT03044886|141436467|SUPERIORITY|||||||0.073|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine changes from 3 month to 6 month of all groups.||||0.073
70965339|NCT03044886|141436468|SUPERIORITY|||||||0.348|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.348
70965340|NCT03044886|141436469|SUPERIORITY|||||||0.685|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.685
70965341|NCT03044886|141436470|SUPERIORITY|||||||0.075|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.075
70965342|NCT03044886|141436470|SUPERIORITY|||||||0.083|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine changes from 3 month to 6 month of all groups.||||0.083
70965343|NCT00074581|141436526|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.07|||<|0.0001|TWO_SIDED|95.0|0.02|0.22|||Regression, Cox||The hazard ratio estimate presented (0.07) is a comparison of the early-ART arm (numerator) to the delayed-ART arm (denominator), thus indicating a 93% lower risk of infection among all linked partner infections, during the entire study.|||0.22|0.02|<0.0001
70965344|NCT00074581|141436527|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.31|||<|0.0001|TWO_SIDED|95.0|0.19|0.53|||Regression, Cox||The hazard ratio estimate presented (0.31) is a comparison of the early-ART arm (numerator) to the delayed-ART arm (denominator), thus indicating a 69% lower risk of infection among all partner infections, during the entire study.|||0.53|0.19|<0.0001
70965345|NCT00617604|141436546|SUPERIORITY_OR_OTHER||Difference|3.9|||||TWO_SIDED|90.0|-2.5|10.3||||||||10.3|-2.5|
70965346|NCT00617604|141436547|SUPERIORITY_OR_OTHER||Difference|1.0|||||TWO_SIDED|90.0|-3.1|5.0||||||||5.0|-3.1|
70965347|NCT00617604|141436548|SUPERIORITY_OR_OTHER||Difference|3.0|||||TWO_SIDED|90.0|-4.0|10.1||||||||10.1|-4.0|
70965348|NCT00617604|141436549|SUPERIORITY_OR_OTHER||Difference|1.0|||||TWO_SIDED|90.0|-0.6|2.5||||||||2.5|-0.6|
70965349|NCT00617604|141436550|SUPERIORITY_OR_OTHER||Difference|-5.1|||||TWO_SIDED|90.0|-14.9|4.7||||||||4.7|-14.9|
70965350|NCT00617604|141436551|SUPERIORITY_OR_OTHER||Difference|-9.4|||||TWO_SIDED|90.0|-18.5|0.0||||||||0.0|-18.5|
70965351|NCT00617604|141436552|SUPERIORITY_OR_OTHER||Difference|-1.9|||||TWO_SIDED|90.0|-7.6|3.8||||||||3.8|-7.6|
70965352|NCT00617604|141436553|SUPERIORITY_OR_OTHER||Difference|-1.8|||||TWO_SIDED|90.0|-8.2|4.6||||||||4.6|-8.2|
70965353|NCT00617604|141436554|SUPERIORITY_OR_OTHER||Difference|1.9|||||TWO_SIDED|90.0|-1.3|5.0||||||||5.0|-1.3|
70965354|NCT00617604|141436555|SUPERIORITY_OR_OTHER||Difference|4.6|||||TWO_SIDED|90.0|-1.2|10.4||||||||10.4|-1.2|
70965355|NCT00617604|141436557|SUPERIORITY_OR_OTHER||Difference|2.0|||||TWO_SIDED|90.0|-3.3|7.2||||||||7.2|-3.3|
70965356|NCT00617604|141436562|SUPERIORITY_OR_OTHER||Slope|6.0|||||TWO_SIDED|90.0|-2.7|14.6||||||||14.6|-2.7|
70965357|NCT00617604|141436563|SUPERIORITY_OR_OTHER||Difference|-4.5|||||TWO_SIDED|90.0|-11.2|2.2||||||||2.2|-11.2|
70965358|NCT00617604|141436564|SUPERIORITY_OR_OTHER||Difference|5.2|||||TWO_SIDED|90.0|-4.4|14.7||||||||14.7|-4.4|
70965359|NCT02303704|141436605|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|to check the equality of means|||||<|0.05|TWO_SIDED|||||P-value less than 0.05 was considered significant|t-test, 2 sided|two compare two independent quantitative groups||Null hypothesis was there is no significant difference between the means of two groups||||<0.05
70965360|NCT02303704|141436606|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|to check the equality of means between the two groups|||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
70965361|NCT02303704|141436607|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|to check the equality of means|||||<|0.05|TWO_SIDED|||||p-value \<0.05 was considered significant.|t-test, 2 sided|To compare the means between the two groups, to find out the significant difference between Group I and II.||Null Hypothesis: The dose of nor-adrenaline on weaning from CPB is same for Group I and II.||||<0.05
70965362|NCT02303704|141436608|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|to chek the equality of means between the two groups|||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
70965363|NCT02303704|141436609|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|||||p- value less than 0.05 was considered as significant difference in proportion between the two groups|Chi-squared|two compare the qualitative data between two groups||Null Hypothesis:The proportion of IABP use is same between the two groups||||<0.05
70965364|NCT02303704|141436610|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|||||P-value \<0.05 was considered to be significant i.e. operative mortality is not same between the two groups|Fisher Exact|Fisher exact test was used because 1 cell (25%) have expected count less than 5.||Null Hypothesis: Operative mortality ratio is same in both groups||||<0.05
70965365|NCT00705432|141436626|SUPERIORITY_OR_OTHER||The difference in SVR|26.6|||<|0.0001|TWO_SIDED|95.0|19.1|34.1|||Cochran-Mantel Haenszel Chi-square test|Adjustments were made for for baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||34.1|19.1|<0.0001
70965366|NCT00705432|141436626|SUPERIORITY_OR_OTHER||The difference in SVR|28.3|||<|0.0001|TWO_SIDED|95.0|20.8|35.8|||Cochran-Mantel Haenszel Chi-square test|Adjustments were made for baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||35.8|20.8|<0.0001
70965367|NCT00705432|141436626|SUPERIORITY_OR_OTHER||The difference in SVR|19.2||||0.044|TWO_SIDED|95.0|1.6|36.9|||Cochran-Mantel Haenszel Chi-square test|Adjustments were made for the baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||36.9|1.6|0.0440
70965368|NCT00705432|141436626|SUPERIORITY_OR_OTHER||The difference in SVR|29.7||||0.0035|TWO_SIDED|95.0|12.2|47.1|||Cochran-Mantel Haenszel Chi-square|Adjustments were made for the baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||47.1|12.2|0.0035
70965369|NCT00705432|141436627|SUPERIORITY_OR_OTHER||The difference in SVR rates|27.5|||<|0.0001|TWO_SIDED|95.0|19.2|35.2|||Cochran-Mantel Haenszel Chi-square|Adjustments were made for the baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||35.2|19.2|<0.0001
70965370|NCT00705432|141436627|SUPERIORITY_OR_OTHER||The difference in SVR rates|29.1|||<|0.0001|TWO_SIDED|95.0|21.5|36.8|||Cochran-Mantel Haenszel Chi-square|Adjustments were made for the baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||36.8|21.5|<0.0001
70965371|NCT00705432|141436627|SUPERIORITY_OR_OTHER||The difference in SVR|21.3||||0.0366|TWO_SIDED|95.0|2.3|40.2|||Cochran-Mantel Haenszel Chi-square test|Adjustments were made for the baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||40.2|2.3|0.0366
70965372|NCT00705432|141436627|SUPERIORITY_OR_OTHER||The difference in SVR|27.2||||0.0107|TWO_SIDED|95.0|9.0|45.3|||Cochran-Mantel Haenszel Chi-square|Adjustments were made for the baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||45.3|9.0|0.0107
70965373|NCT01034540|141436644|SUPERIORITY_OR_OTHER_LEGACY|||||||0.959||||||Values were not normally distributed, thus analyses were performed on ranked values and medians (IQL) are presented.|ANOVA|All tests of statistical significance were completed at the 5% level, two-tailed (p\<0.05).||An evaluable sample of 19 subjects provided 80% power (5% alpha-level, 2-tailed) to detect a 2.1 unit difference between control and active in MISI, assuming a 3.0 unit standard deviation (SD). Repeated measures ANOVA was used to assess responses to treatment. Initial repeated measures models contained terms of treatment period, and sequence as fixed effects, with subject modeled as random effect; models were reduced until only significant terms or treatment remained.||||0.959
70965374|NCT01034540|141436645|SUPERIORITY_OR_OTHER_LEGACY|||||||0.037|||||||ANOVA|All tests of statistical significance were completed at the 5% level, two-tailed (p\<0.05).||||||0.037
70965375|NCT01034540|141436645|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073||||||All tests of statistical significance were completed at the 5% level, two-tailed (p\<0.05).|ANOVA|||||||0.073
70965376|NCT02347488|141436652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_DEVIATION|1.8|<|0.001|TWO_SIDED|95.0|2.88|3.32|||ANCOVA|||Average displacement difference in cm, tape vs. tube-holder. 17 participants was the estimated enrollment needed to detect a difference of 1 SD from the mean between the 2 fixation techniques at 80% power; additional enrollment was included to increase the power of results and to include a larger variety of patients undergoing different surgical procedures.||3.32|2.88|<0.001
70965377|NCT04376827|141436669|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.7807|TWO_SIDED|80.0|0.27|1.41|||log-rank test||Hazard ratio and 80% CI: estimated by Cox proportional hazards model adjusting for baseline UPCR level (\<3 mg/mg and \>=3 mg/mg).|||1.41|0.27|0.7807
70965378|NCT04376827|141436670|SUPERIORITY||Hazard Ratio (HR)|1.52||||0.4654|TWO_SIDED|80.0|0.62|3.85|||long-rank test||Hazard ratio and 80% CI: estimated by Cox proportional hazards model adjusting for baseline UPCR level (\<3 mg/mg and \>=3 mg/mg).|||3.85|0.62|0.4654
70965379|NCT01480284|141436787|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was judged based on the one-sided test of the model, y(Δ) = Baseline + Group ( Δ= -1.0). The adjusted mean values of the TDF group and the ETV group were calculated, and the adjusted mean value and two-sided 95% confidence interval of differences between the TDF group and the ETV group were calculated. Non-inferiority was also to be confirmed when the upper limit of the calculated two-sided 95% confidence interval was less than the non-inferiority limit value of 1.0|Mean Difference (Final Values)|-0.13|||<|0.0001|TWO_SIDED|95.0|-0.28|0.02||p-value was compared with the significance level of 0.025|ANCOVA|||||0.02|-0.28|<0.0001
70965380|NCT01480284|141436788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.4|0.39|||||CI and estimate difference is provided for change from Baseline in serum HBV DNA level at Week 48.|||0.39|-0.40|
70965381|NCT01641237|141436799|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.||Test for linear dose-response relationship was performed for %SMHR as a function of fluoride concentration.||||<0.0001
70965382|NCT01641237|141436799|SUPERIORITY_OR_OTHER|||||||0.3748||95.0|||||ANOVA|Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.||Test for quadratic dose-response relationship was performed for %SMHR as a function of fluoride concentration.||||0.3748
70965383|NCT01641237|141436800|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.17||||0.1898|TWO_SIDED|95.0|-1.09|5.43||No adjustment was required for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment and the subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered treatments in comparison to be equal.||5.43|-1.09|0.1898
70965384|NCT01641237|141436800|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.6||||0.0009|TWO_SIDED|95.0|2.35|8.86||No adjustment was required for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment and the subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no dose-response relationship between %SMHR and fluoride concentration in the dentifrice.||8.86|2.35|0.0009
70965385|NCT01641237|141436800|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.43||||0.0389|TWO_SIDED|95.0|0.18|6.68||No adjustment was required for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment and the subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered treatments in comparison to be equal.||6.68|0.18|0.0389
70965386|NCT01641237|141436800|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.86|||<|0.0001|TWO_SIDED|95.0|6.58|13.13||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered treatments in comparison to be equal.||13.13|6.58|<0.0001
70965387|NCT01641237|141436800|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.68|||<|0.0001|TWO_SIDED|95.0|4.41|10.96||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered treatments in comparison to be equal.||10.96|4.41|<0.0001
70965388|NCT01641237|141436800|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.25||||0.0112|TWO_SIDED|95.0|0.98|7.53||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered treatments in comparison to be equal.||7.53|0.98|0.0112
70965389|NCT01641237|141436801|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.||Test for linear dose-response relationship was performed for %RER as a function of fluoride concentration.||||<0.0001
70965390|NCT01641237|141436801|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANOVA|||Test for quadratic dose-response relationship was performed for %RER as a function of fluoride concentration.||||0.0002
70965391|NCT01641237|141436801|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|32.38|||<|0.0001|TWO_SIDED|95.0|25.18|39.59||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||39.59|25.18|<0.0001
70965392|NCT01641237|141436801|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|31.46|||<|0.0001|TWO_SIDED|95.0|24.25|38.67||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||38.67|24.25|<0.0001
70965393|NCT01641237|141436801|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|20.81|||<|0.0001|TWO_SIDED|95.0|13.6|28.02||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||28.02|13.60|<0.0001
70965394|NCT01641237|141436801|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.92||||0.8|TWO_SIDED|95.0|-6.25|8.1||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||8.10|-6.25|0.8000
70965395|NCT01641237|141436801|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.57||||0.0017|TWO_SIDED|95.0|4.4|18.74||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||18.74|4.40|0.0017
70965396|NCT01641237|141436801|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.65||||0.0038|TWO_SIDED|95.0|3.48|17.81||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||17.81|3.48|0.0038
70965397|NCT01641237|141436802|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.||Test for linear dose-response relationship was performed for EFU as a function of fluoride concentration.||||<0.0001
70965398|NCT01641237|141436802|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||ANOVA|Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.||Test for quadratic dose-response relationship was performed for EFU as a function of fluoride concentration.||||0.0008
70965399|NCT01641237|141436802|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.66|||<|0.0001|TWO_SIDED|95.0|1.42|1.9||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||1.90|1.42|<0.0001
70965400|NCT01641237|141436802|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.6|||<|0.0001|TWO_SIDED|95.0|1.36|1.85||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||1.85|1.36|<0.0001
70965401|NCT01641237|141436802|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.62|||<|0.0001|TWO_SIDED|95.0|0.38|0.86||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||0.86|0.38|<0.0001
70965402|NCT01641237|141436802|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.05||||0.668|TWO_SIDED|95.0|-0.19|0.29||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||0.29|-0.19|0.6680
70965403|NCT01641237|141436802|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.04|||<|0.0001|TWO_SIDED|95.0|0.8|1.28||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||1.28|0.80|<0.0001
70965404|NCT01641237|141436802|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.99|||<|0.0001|TWO_SIDED|95.0|0.75|1.23||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||1.23|0.75|<0.0001
70965405|NCT00709111|141436803|SUPERIORITY_OR_OTHER|||||||0.97||||||The p-value is one-sided with a nominal level of 0.05.|Wilcoxon signed-rank, 1-sided|||The change in CD4+ T-cell count from baseline to week 24 was compared against the null hypothesis of change \<20 cells/mm\^3. The study was powered to yield 80% power to show that there was \>=20 cells/mm\^3 increase in CD4+ T-cell count assuming an underlying change in CD4+ T-cell counts induced by MVC of 50 cells/mm\^3, a standard deviation of 60 cells/mm\^3 around the mean CD4+ T-cell count change, 10% lost-to-follow-up or premature MVC discontinuation rate, and one-sided type 1 error of 0.05.||||0.97
70965406|NCT02716675|141436849|OTHER||Prevention Efficacy (PE)|26.6||||0.15|TWO_SIDED|95.0|-11.7|51.8||The threshold for statistical significance was p = 0.05.|wald|||The primary PE analysis tests the null hypothesis PE equal to zero versus the alternative hypothesis PE not equal to zero using a 2-sided alpha equal 0.05 level Wald test of the equality of log cumulative hazard functions at the week 80 visit for the pooled VRC01 group versus the placebo group.||51.8|-11.7|0.15
70965407|NCT02716675|141436849|OTHER||Prevention Efficacy (PE)|22.4|||||TWO_SIDED|95.0|-25.5|52.0||||||A secondary analysis assesses the overall PE of the low-dose VRC01 group versus the placebo group.||52.0|-25.5|
70965408|NCT02716675|141436849|OTHER||Prevention Efficacy (PE)|30.9|||||TWO_SIDED|95.0|-13.9|58.0||||||A secondary analysis assesses the overall PE of the high-dose VRC01 group versus the placebo group.||58.0|-13.9|
70965409|NCT02716675|141436851|OTHER||Prevention Efficacy (PE)|73.0|||||TWO_SIDED|95.0|27.6|89.9||||||PE against IC80 of least sensitive variant less than 1||89.9|27.6|
70965410|NCT02716675|141436851|OTHER||Prevention Efficacy (PE)|6.1|||||TWO_SIDED|95.0|-174.3|67.8||||||PE against IC80 of least sensitive variant 1-3||67.8|-174.3|
70965411|NCT02716675|141436851|OTHER||Prevention Efficacy (PE)|8.6|||||TWO_SIDED|95.0|-68.1|50.3||||||PE against IC80 of least sensitive variant \> 3||50.3|-68.1|
70965412|NCT01301456|141436878|SUPERIORITY_OR_OTHER||Least square (LS) mean|-21.16|STANDARD_ERROR_OF_MEAN|16.766||0.219|TWO_SIDED|80.0|-43.26|0.93|||Mixed meal tolerance test|||Day 30||0.93|-43.26|0.219
70965413|NCT01301456|141436878|SUPERIORITY_OR_OTHER||LS mean|-34.18|STANDARD_ERROR_OF_MEAN|15.189||0.034|TWO_SIDED|80.0|-54.2|-14.16|||Mixed meal tolerance test|||Day 30||-14.16|-54.20|0.034
70965414|NCT01301456|141436878|SUPERIORITY_OR_OTHER||LS mean|-33.67|STANDARD_ERROR_OF_MEAN|15.806||0.044|TWO_SIDED|80.0|-54.5|-12.84|||Mixed meal tolerance test|||Day 30||-12.84|-54.50|0.044
70965415|NCT01301456|141436878|SUPERIORITY_OR_OTHER||LS mean|-2.93|STANDARD_ERROR_OF_MEAN|16.111||0.857|TWO_SIDED|80.0|-24.16|18.31|||Mixed meal tolerance test|||Day 30||18.31|-24.16|0.857
70965416|NCT01301456|141436879|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.251||0.419|TWO_SIDED|80.0|-0.54|0.12|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||0.12|-0.54|0.419
70965417|NCT01301456|141436879|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.224||0.077|TWO_SIDED|80.0|-0.71|-0.12|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-0.12|-0.71|0.077
70965418|NCT01301456|141436879|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.23||0.147|TWO_SIDED|80.0|-0.65|-0.04|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-0.04|-0.65|0.147
70965419|NCT01301456|141436879|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.244||0.086|TWO_SIDED|80.0|-0.76|-0.11|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-0.11|-0.76|0.086
70965420|NCT01301456|141436881|SUPERIORITY_OR_OTHER||LS Mean Difference|4.11|STANDARD_ERROR_OF_MEAN|9.326||0.663|TWO_SIDED|80.0|-8.16|16.37|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||16.37|-8.16|0.663
70965421|NCT01301456|141436881|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.89|STANDARD_ERROR_OF_MEAN|8.472||0.825|TWO_SIDED|80.0|-13.03|9.25|||mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||9.25|-13.03|0.825
70965422|NCT01301456|141436881|SUPERIORITY_OR_OTHER||LS Mean Difference|1.36|STANDARD_ERROR_OF_MEAN|8.791||0.878|TWO_SIDED|80.0|-10.2|12.92|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||12.92|-10.20|0.878
70965423|NCT01301456|141436881|SUPERIORITY_OR_OTHER||LS Mean Difference|0.72|STANDARD_ERROR_OF_MEAN|8.829||0.936|TWO_SIDED|80.0|-10.89|12.33|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||12.33|-10.89|0.936
70965424|NCT01301456|141436881|SUPERIORITY_OR_OTHER||LS Mean Difference|0.68|STANDARD_ERROR_OF_MEAN|13.037||0.959|TWO_SIDED|80.0|-16.46|17.82|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||17.82|-16.46|0.959
70965425|NCT01301456|141436881|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.46|STANDARD_ERROR_OF_MEAN|11.872||0.011|TWO_SIDED|80.0|-48.07|-16.85|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-16.85|-48.07|0.011
70965426|NCT01301456|141436881|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.61|STANDARD_ERROR_OF_MEAN|12.212||0.833|TWO_SIDED|80.0|-18.67|13.45|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||13.45|-18.67|0.833
70965427|NCT01301456|141436881|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.21|STANDARD_ERROR_OF_MEAN|12.365||0.565|TWO_SIDED|80.0|-23.47|9.05|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||9.05|-23.47|0.565
70965428|NCT01301456|141436881|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.75|STANDARD_ERROR_OF_MEAN|9.713||0.703|TWO_SIDED|80.0|-16.52|9.02|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||9.02|-16.52|0.703
70965429|NCT01301456|141436881|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.46|STANDARD_ERROR_OF_MEAN|8.827||0.008|TWO_SIDED|80.0|-37.07|-13.85|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-13.85|-37.07|0.008
70965430|NCT01301456|141436881|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.6|STANDARD_ERROR_OF_MEAN|9.061||0.253|TWO_SIDED|80.0|-22.51|1.32|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.32|-22.51|0.253
70965431|NCT01301456|141436881|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.47|STANDARD_ERROR_OF_MEAN|9.198||0.128|TWO_SIDED|80.0|-26.57|-2.38|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-2.38|-26.57|0.128
70965432|NCT01301456|141436881|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.15|STANDARD_ERROR_OF_MEAN|11.421||0.196|TWO_SIDED|80.0|-30.17|-0.13|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-0.13|-30.17|0.196
70965433|NCT01301456|141436881|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.17|STANDARD_ERROR_OF_MEAN|10.393||0.012|TWO_SIDED|80.0|-41.84|-14.51|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-14.51|-41.84|0.012
70965434|NCT01301456|141436881|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.48|STANDARD_ERROR_OF_MEAN|10.773||0.047|TWO_SIDED|80.0|-36.65|-8.32|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-8.32|-36.65|0.047
70965435|NCT01301456|141436881|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.63|STANDARD_ERROR_OF_MEAN|11.837||0.023|TWO_SIDED|80.0|-44.19|-13.06|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-13.06|-44.19|0.023
70965436|NCT01301456|141436881|SUPERIORITY_OR_OTHER||LS Mean Difference|5.08|STANDARD_ERROR_OF_MEAN|13.576||0.711|TWO_SIDED|80.0|-12.77|22.93|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||22.93|-12.77|0.711
70965437|NCT01301456|141436881|SUPERIORITY_OR_OTHER||LS Mean Difference|5.4|STANDARD_ERROR_OF_MEAN|12.365||0.666|TWO_SIDED|80.0|-10.86|21.66|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||21.66|-10.86|0.666
70965438|NCT01301456|141436881|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.05|STANDARD_ERROR_OF_MEAN|12.333||0.807|TWO_SIDED|80.0|-19.27|13.17|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||13.17|-19.27|0.807
70965439|NCT01301456|141436881|SUPERIORITY_OR_OTHER||LS Mean Difference|6.79|STANDARD_ERROR_OF_MEAN|12.877||0.603|TWO_SIDED|80.0|-10.15|23.72|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||23.72|-10.15|0.603
70965440|NCT01301456|141436883|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.551||0.387|TWO_SIDED|80.0|-0.24|1.21|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.21|-0.24|0.387
70965441|NCT01301456|141436883|SUPERIORITY_OR_OTHER||LS Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.501||0.309|TWO_SIDED|80.0|-0.14|1.18|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.18|-0.14|0.309
70965442|NCT01301456|141436883|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.518||0.956|TWO_SIDED|80.0|-0.71|0.65|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||0.65|-0.71|0.956
70965443|NCT01301456|141436883|SUPERIORITY_OR_OTHER||LS Mean Difference|0.96|STANDARD_ERROR_OF_MEAN|0.542||0.089|TWO_SIDED|80.0|0.24|1.67|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.67|0.24|0.089
70965444|NCT01301456|141436883|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73|STANDARD_ERROR_OF_MEAN|0.923||0.434|TWO_SIDED|80.0|-0.48|1.95|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.95|-0.48|0.434
70965445|NCT01301456|141436883|SUPERIORITY_OR_OTHER||LS Mean Difference|1.25|STANDARD_ERROR_OF_MEAN|0.841||0.15|TWO_SIDED|80.0|0.14|2.35|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.35|0.14|0.150
70965446|NCT01301456|141436883|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.861||0.752|TWO_SIDED|80.0|-0.86|1.41|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.41|-0.86|0.752
70965447|NCT01301456|141436883|SUPERIORITY_OR_OTHER||LS Mean Difference|0.62|STANDARD_ERROR_OF_MEAN|0.888||0.492|TWO_SIDED|80.0|-0.55|1.79|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.79|-0.55|0.492
70965448|NCT01301456|141436883|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.064||0.358|TWO_SIDED|80.0|-0.4|2.4|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.40|-0.40|0.358
70965449|NCT01301456|141436883|SUPERIORITY_OR_OTHER||LS mean Difference|1.6|STANDARD_ERROR_OF_MEAN|0.97||0.11|TWO_SIDED|80.0|0.33|2.88|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.88|0.33|0.110
70965450|NCT01301456|141436883|SUPERIORITY_OR_OTHER||LS mean Difference|0.74|STANDARD_ERROR_OF_MEAN|0.993||0.461|TWO_SIDED|80.0|-0.56|2.05|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.05|-0.56|0.461
70965451|NCT01301456|141436883|SUPERIORITY_OR_OTHER||LS mean Difference|1.11|STANDARD_ERROR_OF_MEAN|1.021||0.286|TWO_SIDED|80.0|-0.23|2.45|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.45|-0.23|0.286
70965452|NCT01301456|141436883|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|STANDARD_ERROR_OF_MEAN|1.172||0.362|TWO_SIDED|80.0|-0.45|2.63|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.63|-0.45|0.362
70965453|NCT01301456|141436883|SUPERIORITY_OR_OTHER||LS Mean Difference|1.48|STANDARD_ERROR_OF_MEAN|1.069||0.179|TWO_SIDED|80.0|0.07|2.88|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.88|0.07|0.179
70965454|NCT01301456|141436883|SUPERIORITY_OR_OTHER||LS Mean Difference|1.06|STANDARD_ERROR_OF_MEAN|1.092||0.342|TWO_SIDED|80.0|-0.38|2.49|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.49|-0.38|0.342
70965455|NCT01301456|141436883|SUPERIORITY_OR_OTHER||LS Mean Difference|1.27|STANDARD_ERROR_OF_MEAN|1.129||0.272|TWO_SIDED|80.0|-0.22|2.75|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.75|-0.22|0.272
70965456|NCT01301456|141436883|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|1.317||0.979|TWO_SIDED|80.0|-1.77|1.7|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.70|-1.77|0.979
70965457|NCT01301456|141436883|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.201||0.568|TWO_SIDED|80.0|-2.27|0.88|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||0.88|-2.27|0.568
70965458|NCT01301456|141436883|SUPERIORITY_OR_OTHER||LS Mean Difference|1.24|STANDARD_ERROR_OF_MEAN|1.201||0.311|TWO_SIDED|80.0|-0.34|2.82|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.82|-0.34|0.311
70965459|NCT01301456|141436883|SUPERIORITY_OR_OTHER||LS Mean Difference|0.47|STANDARD_ERROR_OF_MEAN|1.26||0.71|TWO_SIDED|80.0|-1.18|2.13|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.13|-1.18|0.710
70965460|NCT05368961|141436955|OTHER|Null hypothesis; there is no difference in anxiety scores between usual care and distraction||||||0.44|||||||Wilcoxon (Mann-Whitney)|||||||0.44
70965461|NCT03593850|141436961|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||0.002
70965462|NCT03593850|141436962|EQUIVALENCE|Equivalence analysis was performed according to pre-defined significant difference of p \< 0.01||||||0.392|||||||t-test, 2 sided|||||||0.392
70965463|NCT03593850|141436963|EQUIVALENCE|Equivalence analysis was performed according to pre-defined significant difference of p \< 0.01||||||0.802|||||||t-test, 2 sided|||||||0.802
70965464|NCT03593850|141436964|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
70965465|NCT03593850|141436964|SUPERIORITY||Adjusted mean difference|1.429||||0.006|TWO_SIDED||||||ANCOVA|Fixed factors: group, covariates: pain before (VAS2), age in years, age at menarche, duration of menses, usual pain, anxiety before, hours with pain.|||Adjusted means: music 3.131 (99% CI 2.62, 3.999) and silence 4.56 (99% CI 3.581, 5.538), F= 8.44, R-square 54.5%|||0.006
70965466|NCT03593850|141436965|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
70965467|NCT03593850|141436965|SUPERIORITY||Adjusted mean difference|0.721||||0.37|TWO_SIDED||||||ANCOVA|Fixed factor: Groups Covariates: Pain before, pain after, age, age menarche, menses duration, usual pain, anxiety before, anxiety after, hours pain|Adjusted means: music 2.58 (99% CI 1.339, 3.829), and silence 3.305 (1.728, 4.881); F 0.827, R-square 27.2%|||||0.370
70965468|NCT03593850|141436966|EQUIVALENCE|Equivalence between groups was pre-defined as p \> 0.01||||||0.377|||||||t-test, 2 sided|||||||0.377
70965469|NCT03593850|141436967|SUPERIORITY|||||||0.049|||||||t-test, 2 sided|||||||0.049
70965470|NCT03593850|141436968|SUPERIORITY|||||||0.168|||||||t-test, 2 sided|||||||0.168
70965471|NCT03593850|141436969|EQUIVALENCE|Equivalence between groups was pre-defined as p \> 0.01||||||0.642|||||||Chi-squared|||||||0.642
70965472|NCT03593850|141436970|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||0.02
70965473|NCT03593850|141436971|SUPERIORITY|||||||0.025|||||||Chi-squared|||||||0.025
70965474|NCT03593850|141436972|EQUIVALENCE|Equivalence between groups determined by pre-deined p \> 0.01||||||0.307|||||||t-test, 2 sided|||||||0.307
70965475|NCT03593850|141436973|EQUIVALENCE|Equivalence between groups determined by pre-deined p \> 0.01||||||0.318|||||||t-test, 2 sided|||||||0.318
70965476|NCT03593850|141436974|EQUIVALENCE|Equivalence between groups determined by pre-deined p \> 0.01||||||0.954|||||||t-test, 2 sided|||||||0.954
70965477|NCT03593850|141436975|EQUIVALENCE|Equivalence between groups determined by pre-deined p \> 0.01||||||0.258|||||||t-test, 2 sided|||||||0.258
70965478|NCT03593850|141436976|SUPERIORITY|||||||0.058|||||||t-test, 2 sided|||||||0.058
70965479|NCT03593850|141436977|SUPERIORITY|||||||0.056|||||||t-test, 2 sided|||||||0.056
70965480|NCT03593850|141436978|SUPERIORITY|||||||0.885|||||||t-test, 2 sided|||||||0.885
70965481|NCT03593850|141436979|SUPERIORITY|||||||0.036|||||||t-test, 2 sided|||||||0.036
70965482|NCT01735279|141436983|OTHER|Test t Student|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
70965483|NCT01735279|141436983|SUPERIORITY||Mean Difference (Final Values)|30.84|||<|0.01|ONE_SIDED|95.0|||||ANOVA|||||||<0.01
70965484|NCT01735279|141436983|SUPERIORITY||Mean Difference (Final Values)|0.002|||<|0.01|TWO_SIDED||||||t-test, 1 sided|||||||<0.01
70965485|NCT01735279|141436983|SUPERIORITY||Mean Difference (Final Values)|4.4|||<|0.01|ONE_SIDED||||||t-test, 1 sided|||||||<0.01
70965486|NCT00119041|141436988|SUPERIORITY_OR_OTHER||||||>|0.153|TWO_SIDED|||||Threshold for statistical significance was p\<0.025 using Bonferroni correction for 2 statistical tests.|t-test, 2 sided|||Comparisons were made between the intervention and control groups at baseline||||>0.153
70965487|NCT00119041|141436988|SUPERIORITY_OR_OTHER||||||>|0.25|TWO_SIDED|||||Threshold for statistical significance was p\<0.025 using Bonferroni correction for 2 statistical tests.|t-test, 2 sided|Threshold for statistical significance was p\<0.025 using Bonferroni correction for 2 statistical tests.||Comparisons were made between the intervention and control groups at 18 months||||>0.25
70965488|NCT00922480|141437008|NON_INFERIORITY|Non-Inferiority||||||0.0001|||||||t-test, 2 sided|Paired t-test||||||0.0001
70965489|NCT00922480|141437009|NON_INFERIORITY|Non-Inferiority||||||0.0001|||||||t-test, 2 sided|Paired t-test||||||0.0001
70965490|NCT01011439|141437010|SUPERIORITY||Single proportion|0.44|||<|0.001|TWO_SIDED|95.0|0.31|0.59|||Fisher Exact|||H0:p\</=17% vs. H1:p\>17%, with an interesting PFS-3 rate of 33% or higher; Power=80%; Alpha(1-sided)=5%, 54 evaluable patients are required for a Simon optimal two stage design trial. If at least 4 successes among the first 17 evaluable patients are observed in the 1st stage, patients' enrollment proceed up to the final analysis where at least 14/54 successes (PFS-3 rate ≥ 25.9%) must be required to reject the null hypothesis.||0.59|0.31|<0.001
70965491|NCT01372150|141437017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.71||||0.226|TWO_SIDED|95.0|-1.06|4.48|||Mixed-effects model for repeated measure|Mixed-effects model for repeated measures (MMRM)|Adjusted mean difference = placebo - fluoxetine|Fluoxetine versus Placebo||4.48|-1.06|0.226
70965492|NCT01372150|141437017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.739|TWO_SIDED|95.0|-3.23|2.3|||MMRM||Adjusted mean difference = Placebo - DVS SR|DVS SR versus Placebo||2.30|-3.23|0.739
70965493|NCT01372150|141437018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.224|TWO_SIDED|95.0|-0.11|0.46|||MMRM||Adjusted mean difference = Placebo - Fluoxetine|Fluoxetine versus Placebo||0.46|-0.11|0.224
70965494|NCT01372150|141437018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.944|TWO_SIDED|95.0|-0.29|0.27|||MMRM||Adjusted mean difference = Placebo - DVS SR|DVS SR versus Placebo||0.27|-0.29|0.944
70965495|NCT01372150|141437019|SUPERIORITY_OR_OTHER|||||||0.924||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 1||||0.924
70965496|NCT01372150|141437019|SUPERIORITY_OR_OTHER|||||||0.698||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 1||||0.698
70965497|NCT01372150|141437019|SUPERIORITY_OR_OTHER|||||||0.214||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 2||||0.214
70965498|NCT01372150|141437019|SUPERIORITY_OR_OTHER|||||||0.113||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 2||||0.113
70965499|NCT01372150|141437019|SUPERIORITY_OR_OTHER|||||||0.314||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 3||||0.314
70965500|NCT01372150|141437019|SUPERIORITY_OR_OTHER|||||||0.659||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 3||||0.659
70965501|NCT01372150|141437019|SUPERIORITY_OR_OTHER|||||||0.577||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 4||||0.577
70965502|NCT01372150|141437019|SUPERIORITY_OR_OTHER|||||||0.187||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 4||||0.187
70965503|NCT01372150|141437019|SUPERIORITY_OR_OTHER|||||||0.051||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 6||||0.051
70965504|NCT01372150|141437019|SUPERIORITY_OR_OTHER|||||||0.266||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 6||||0.266
70965505|NCT01372150|141437019|SUPERIORITY_OR_OTHER|||||||0.095||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 8||||0.095
70965506|NCT01372150|141437019|SUPERIORITY_OR_OTHER|||||||0.852||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 8||||0.852
70965507|NCT01372150|141437020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55||||0.186|TWO_SIDED|95.0|0.226|1.335|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Fluoxetine versus Placebo - Week 1||1.335|0.226|0.186
70965508|NCT01372150|141437020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.984|TWO_SIDED|95.0|0.382|2.567|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 1||2.567|0.382|0.984
70965509|NCT01372150|141437020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.795||||0.462|TWO_SIDED|95.0|0.431|1.465|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Fluoxetine versus Placebo - Week 2||1.465|0.431|0.462
70965510|NCT01372150|141437020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.726||||0.297|TWO_SIDED|95.0|0.399|1.324|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 2||1.324|0.399|0.297
70965511|NCT01372150|141437020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.688||||0.194|TWO_SIDED|95.0|0.391|1.21|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Fluoxetine versus Placebo - Week 3||1.210|0.391|0.194
70965512|NCT01372150|141437020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.732||||0.272|TWO_SIDED|95.0|0.419|1.277|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 3||1.277|0.419|0.272
70965513|NCT01372150|141437020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.748||||0.313|TWO_SIDED|95.0|0.426|1.314|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Flouxetine versus Placebo - Week 4||1.314|0.426|0.313
70965514|NCT01372150|141437020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.663||||0.157|TWO_SIDED|95.0|0.376|1.171|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 4||1.171|0.376|0.157
70965515|NCT01372150|141437020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.579||||0.072|TWO_SIDED|95.0|0.319|1.05|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Flouxetine versus Placebo - Week 6||1.050|0.319|0.072
70965516|NCT01372150|141437020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.135|TWO_SIDED|95.0|0.356|1.149|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 6||1.149|0.356|0.135
70965517|NCT01372150|141437020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.465||||0.017|TWO_SIDED|95.0|0.249|0.871|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Flouxetine versus Placebo - Week 8||0.871|0.249|0.017
70965518|NCT01372150|141437020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.751||||0.343|TWO_SIDED|95.0|0.415|1.357|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 8||1.357|0.415|0.343
70965519|NCT05215262|141437041|SUPERIORITY||Mean Difference (Final Values)|1.87||||0.04|TWO_SIDED|95.0|0.04|3.17|||Mixed Models Analysis|||||3.17|0.04|0.04
70965520|NCT05215262|141437041|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.82|TWO_SIDED|95.0|-1.59|1.99|||Mixed Models Analysis|||||1.99|-1.59|0.82
70965521|NCT05215262|141437041|SUPERIORITY||Mean Difference (Final Values)|1.67||||0.2|TWO_SIDED|95.0|-0.89|4.23|||Mixed Models Analysis|||Difference-in-differences results, comparing GSES scores between the Intervention and Standard of Care groups at the three-month time point.||4.23|-0.89|0.20
70965522|NCT00718549|141437052|SUPERIORITY|||||||0.028|||||||Log Rank|||||||0.028
70965523|NCT00718549|141437052|SUPERIORITY||Hazard Ratio (HR)|0.418||||0.033||95.0|0.187|0.933|||Cox's proportional hazards regression|||Univariate comparison||0.933|0.187|0.033
70965524|NCT00718549|141437052|SUPERIORITY||Hazard Ratio (HR)|0.052||||0.111|TWO_SIDED|95.0|0.001|1.972|||Cox's proportional hazards model|||Multivariate Comparison||1.972|0.001|0.111
70965525|NCT00718549|141437053|SUPERIORITY||Odds Ratio (OR)|3.654||||0.155|TWO_SIDED|95.0|0.674|28.337|||Regression, Logistic|||Week 129: Univariate Comparison||28.337|0.674|0.155
70965526|NCT00718549|141437054|SUPERIORITY||Odds Ratio (OR)|0.625||||0.634|TWO_SIDED|95.0|0.073|4.114|||Regression, Logistic|||Week 129: Univariate comparison||4.114|0.073|0.634
70965527|NCT00718549|141437055|SUPERIORITY||Hazard Ratio (HR)|0.769||||0.752|TWO_SIDED|95.0|0.151|3.92|||Cox's proportional hazards model|||Multivariate Comparison: Age \<60 years versus Age \>/=60 years||3.920|0.151|0.752
70965528|NCT00718549|141437055|SUPERIORITY||Hazard Ratio (HR)|0.068||||0.128|TWO_SIDED|95.0|0.002|2.158|||Cox's proportional hazards model|||Multivariate Comparison: Sex: Female versus Male||2.158|0.002|0.128
70965529|NCT00718549|141437055|SUPERIORITY||Hazard Ratio (HR)|2.282||||0.728|TWO_SIDED|95.0|0.022|240.864|||Cox's proportional hazards model|||Multivariate Comparison: Rai Stage: I or II versus Rai Stage: III or IV||240.864|0.022|0.728
70965530|NCT00718549|141437055|SUPERIORITY||Hazard Ratio (HR)|26.275||||0.048|TWO_SIDED|95.0|1.036|666.708|||Cox's proportional hazards model|||Multivariate Comparison: Beta-2-Microglobulin \>/= Median Value versus Beta-2-Microglobulin \<Median Value||666.708|1.036|0.048
70965531|NCT00718549|141437055|SUPERIORITY||Hazard Ratio (HR)|0.21||||0.417|TWO_SIDED|95.0|0.005|9.1|||Cox's proportional hazards model|||Multivariate Comparison: ZAP-70 Expression Negative versus Positive||9.100|0.005|0.417
70965532|NCT00718549|141437055|SUPERIORITY||Hazard Ratio (HR)|0.197||||0.134|TWO_SIDED|95.0|0.024|1.647|||Cox's proportional hazards model|||Multivariate Comparison: CD38 Expression Negative versus Positive||1.647|0.024|0.134
70965533|NCT00718549|141437055|SUPERIORITY||Hazard Ratio (HR)|8.373||||0.426|TWO_SIDED|95.0|0.045|1568.717|||Cox's proportional hazards model|||Multivariate Comparison: Cytogenetic abnormality 17p No versus Yes||1568.717|0.045|0.426
70965534|NCT00718549|141437055|SUPERIORITY||Hazard Ratio (HR)|0.438||||0.733|TWO_SIDED|95.0|0.004|50.334|||Cox's proportional hazards model|||Multivariate Comparison: Cytogenetic abnormality 13q No versus Yes||50.334|0.004|0.733
70965535|NCT00718549|141437055|SUPERIORITY||Hazard Ratio (HR)|2.621||||0.463|TWO_SIDED|95.0|0.2|34.422|||Cox's proportional hazards model|||Multivariate Comparison: Cytogenetic abnormality 11q No versus Yes||34.422|0.200|0.463
70965536|NCT00718549|141437055|SUPERIORITY||Hazard Ratio (HR)|0.288||||0.397|TWO_SIDED|95.0|0.016|5.122|||Cox's proportional hazards model|||Multivariate Comparison: Cytogenetic abnormality 12q No versus Yes||5.122|0.016|0.397
70965537|NCT00718549|141437056|SUPERIORITY||Odds Ratio (OR)|0.982||||0.969|TWO_SIDED|95.0|0.393|2.531|||Regression, Logistic|||Univariate Comparison: Age \<60 years versus Age \>/=60 years||2.531|0.393|0.969
70965538|NCT00718549|141437056|SUPERIORITY||Odds Ratio (OR)|0.552||||0.26|TWO_SIDED|95.0|0.183|1.488|||Regression, Logistic|||Univariate Comparison: Sex: Female versus Male||1.488|0.183|0.260
70965539|NCT00718549|141437056|SUPERIORITY||Odds Ratio (OR)|0.465||||0.121|TWO_SIDED|95.0|0.177|1.242|||Regression, Logistic|||Univariate Comparison: Rai Stage: I or II versus Rai Stage: III or IV||1.242|0.177|0.121
70965540|NCT00718549|141437056|SUPERIORITY||Odds Ratio (OR)|0.374||||0.045|TWO_SIDED|95.0|0.137|0.957|||Regression, Logistic|||Univariate Comparison: Beta-2-Microglobulin \>/= Median Value versus Beta-2-Microglobulin \<Median Value||0.957|0.137|0.045
70965541|NCT00718549|141437056|SUPERIORITY||Odds Ratio (OR)|8.809||||0.04|TWO_SIDED|95.0|1.655|163.316|||Regression, Logistic|||Univariate Comparison: ZAP-70 Expression Negative versus Positive||163.316|1.655|0.040
70965542|NCT00718549|141437056|SUPERIORITY||Odds Ratio (OR)|0.921||||0.887|TWO_SIDED|95.0|0.287|2.851|||Regression, Logistic|||Univariate Comparison: CD38 Expression Negative versus Positive||2.851|0.287|0.887
70965543|NCT00718549|141437056|SUPERIORITY||Odds Ratio (OR)|0.932||||0.936|TWO_SIDED|95.0|0.186|6.839|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 17p No versus Yes||6.839|0.186|0.936
70965544|NCT00718549|141437056|SUPERIORITY||Odds Ratio (OR)|1.88||||0.199|TWO_SIDED|95.0|0.719|5.012|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 13q No versus Yes||5.012|0.719|0.199
70965545|NCT00718549|141437056|SUPERIORITY||Odds Ratio (OR)|1.668||||0.375|TWO_SIDED|95.0|0.566|5.649|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 11q No versus Yes||5.649|0.566|0.375
70965546|NCT00718549|141437056|SUPERIORITY||Odds Ratio (OR)|0.957||||0.961|TWO_SIDED|95.0|0.173|7.275|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 12q No versus Yes||7.275|0.173|0.961
70965547|NCT00718549|141437057|SUPERIORITY||Odds Ratio (OR)|1.31||||0.768|TWO_SIDED|95.0|0.237|10.189|||Regression, Logistic|||Univariate Comparison: Age \<60 years versus Age \>/=60 years||10.189|0.237|0.768
70965548|NCT00718549|141437057|SUPERIORITY||Odds Ratio (OR)|0.667||||0.657|TWO_SIDED|95.0|0.086|3.653|||Regression, Logistic|||Univariate Comparison: Sex: Female versus Male||3.653|0.086|0.657
70965549|NCT00718549|141437057|SUPERIORITY||Odds Ratio (OR)|1.68||||0.655|TWO_SIDED|95.0|0.229|34.486|||Regression, Logistic|||Univariate Comparison: Rai Stage: I or II versus Rai Stage: III or IV||34.486|0.229|0.655
70965550|NCT00718549|141437057|SUPERIORITY||Odds Ratio (OR)|0.635||||0.595|TWO_SIDED|95.0|0.117|3.73|||Regression, Logistic|||Univariate Comparison: Beta-2-Microglobulin \>/= Median Value versus Beta-2-Microglobulin \<Median Value||3.730|0.117|0.595
70965551|NCT00718549|141437057|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.164|8.102|||Regression, Logistic|||Univariate Comparison: ZAP-70 Expression Negative versus Positive||8.102|0.164|1.000
70965552|NCT00718549|141437057|SUPERIORITY||Odds Ratio (OR)|0.857||||0.882|TWO_SIDED|95.0|0.093|6.636|||Regression, Logistic|||Univariate Comparison: CD38 Expression Negative versus Positive||6.636|0.093|0.882
70965553|NCT00718549|141437057|SUPERIORITY||Odds Ratio (OR)|0.154||||0.216|TWO_SIDED|95.0|0.005|4.405|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 17p No versus Yes||4.405|0.005|0.216
70965554|NCT00718549|141437057|SUPERIORITY||Odds Ratio (OR)|0.361||||0.396|TWO_SIDED|95.0|0.017|2.971|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 13q No versus Yes||2.971|0.017|0.396
70965555|NCT00718549|141437057|SUPERIORITY||Odds Ratio (OR)|0.75||||0.776|TWO_SIDED|95.0|0.103|6.572|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 11q No versus Yes||6.572|0.103|0.776
70965556|NCT00718549|141437058|SUPERIORITY||Odds Ratio (OR)|0.528||||0.357|TWO_SIDED|95.0|0.131|2.114|||Regression, Logistic|||Univariate Comparison: Age \<60 years versus Age \>/=60 years||2.114|0.131|0.357
70965557|NCT00718549|141437058|SUPERIORITY||Odds Ratio (OR)|0.694||||0.623|TWO_SIDED|95.0|0.138|2.8|||Regression, Logistic|||Univariate Comparison: Sex: Female versus Male||2.800|0.138|0.623
70965558|NCT00718549|141437058|SUPERIORITY||Odds Ratio (OR)|4.0||||0.097|TWO_SIDED|95.0|0.901|28.158|||Regression, Logistic|||Univariate Comparison: Beta-2-Microglobulin \>/= Median Value versus Beta-2-Microglobulin \<Median Value||28.158|0.901|0.097
70965559|NCT00718549|141437058|SUPERIORITY||Odds Ratio (OR)|4.2||||0.233|TWO_SIDED|95.0|0.484|89.588|||Regression, Logistic|||Univariate Comparison: CD38 Expression Negative versus Positive||89.588|0.484|0.233
70965560|NCT00718549|141437058|SUPERIORITY||Odds Ratio (OR)|0.844||||0.826|TWO_SIDED|95.0|0.161|3.681|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 13q No versus Yes||3.681|0.161|0.826
70965561|NCT00718549|141437058|SUPERIORITY||Odds Ratio (OR)|1.067||||0.933|TWO_SIDED|95.0|0.246|5.581|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 11q No versus Yes||5.581|0.246|0.933
70965562|NCT00718549|141437058|SUPERIORITY||Odds Ratio (OR)|0.727||||0.794|TWO_SIDED|95.0|0.08|15.779|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 12q No versus Yes||15.779|0.080|0.794
70965563|NCT00718549|141437059|SUPERIORITY||Odds Ratio (OR)|1.923||||0.591|TWO_SIDED|95.0|0.225|41.751|||Regression, Logistic|||Univariate Comparison: Age \<60 years versus Age \>/=60 years||41.751|0.225|0.591
70965564|NCT00718549|141437059|SUPERIORITY||Odds Ratio (OR)|1.3||||0.796|TWO_SIDED|95.0|0.147|9.222|||Regression, Logistic|||Univariate Comparison: Sex: Female versus Male||9.222|0.147|0.796
70965565|NCT00718549|141437059|SUPERIORITY||Odds Ratio (OR)|3.2||||0.338|TWO_SIDED|95.0|0.375|69.479|||Regression, Logistic|||Univariate Comparison: Beta-2-Microglobulin \>/= Median Value versus Beta-2-Microglobulin \<Median Value||69.479|0.375|0.338
70965566|NCT00718549|141437059|SUPERIORITY||Odds Ratio (OR)|2.333||||0.486|TWO_SIDED|95.0|0.201|29.008|||Regression, Logistic|||Univariate Comparison: CD38 Expression Negative versus Positive||29.008|0.201|0.486
70965567|NCT00718549|141437059|SUPERIORITY||Odds Ratio (OR)|0.667||||0.691|TWO_SIDED|95.0|0.074|4.722|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 13q No versus Yes||4.722|0.074|0.691
70965568|NCT00718549|141437059|SUPERIORITY||Odds Ratio (OR)|1.5||||0.691|TWO_SIDED|95.0|0.212|13.563|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 11q No versus Yes||13.563|0.212|0.691
70965569|NCT00718549|141437059|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.076|24.621|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 12q No versus Yes||24.621|0.076|1.000
70965570|NCT00718549|141437059|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.099|22.791|||Regression, Logistic|||Univariate Comparison: Rai Stage: I or II versus Rai Stage: III or IV||22.791|0.099|1.000
70965571|NCT02606461|141437079|SUPERIORITY||Hazard Ratio (HR)|0.7026||||0.0114|TWO_SIDED|95.0|0.5191|0.9509|||Log Rank|||||0.9509|0.5191|0.0114
70965572|NCT02606461|141437081|SUPERIORITY||Hazard Ratio, log|1.1521||||0.6051|TWO_SIDED|95.0|0.5357|2.4778|||Log Rank|||||2.4778|0.5357|0.6051
70965573|NCT03496324|141437105|EQUIVALENCE|Bioequivalence was demonstrated between NfC® and Algifor® Junior if each 90% confidence interval (CI) (rounded to 2 decimal places) for the ratio between least square geometric means (test / reference) lay within 80% and 125% for Cmax.|Geometric Least Square Mean|94.19|STANDARD_ERROR_OF_MEAN|18.9|||TWO_SIDED|90.0|85.81|103.38||||||||103.38|85.81|
70965574|NCT03496324|141437105|EQUIVALENCE|Bioequivalence was demonstrated between NfC® and Algifor® Junior if each 90% CI (rounded to 2 decimal places) for the ratio between least square geometric means (test / reference) lay within 80% and 125% for Cmax.|Geometric Least Square Mean|111.66|STANDARD_ERROR_OF_MEAN|14.3|||TWO_SIDED|90.0|103.84|120.07||||||||120.07|103.84|
70965575|NCT03496324|141437106|EQUIVALENCE|Bioequivalence was demonstrated between NfC® and Algifor® Junior if each 90% CI (rounded to 2 decimal places) for the ratio between least square geometric means (test / reference) lay within 80% and 125% for AUC0-t.|Geometric Least Square Mean|101.57|STANDARD_ERROR_OF_MEAN|10.5|||TWO_SIDED|90.0|96.28|107.16||||||||107.16|96.28|
70965576|NCT03496324|141437106|EQUIVALENCE|Bioequivalence was demonstrated between NfC® and Algifor® Junior if each 90% CI (rounded to 2 decimal places) for the ratio between least square geometric means (test / reference) lay within 80% and 125% for AUC0-t.|Geometric Least Square Mean|104.47|STANDARD_ERROR_OF_MEAN|6.0|||TWO_SIDED|90.0|101.4|107.63||||||||107.63|101.4|
70965577|NCT02092350|141437113|SUPERIORITY_OR_OTHER|||||||0.001|||||||One-sided exact test|||The primary hypothesis was that the SVR12 rate in the Immediate Treatment plus Intensive PK arm would be \>45%.||||0.001
70965578|NCT00239226|141437118|SUPERIORITY_OR_OTHER||Slope|3.93||||0.047|||||||Log Rank|||||||0.047
70965579|NCT00646906|141437134|SUPERIORITY|An analysis of variance, appropriate for a three factor experiment with cohort and dose as non-repeated factors and repeated measure order arranged in a two period cross-over design, was performed.|||||>|0.05|||||||ANOVA|||The primary hypothesis is that acetaminophen given two hours before aspirin will antagonize the effects of aspirin, while reversing the order of administration will not. Percent change from start (8:00 am on day 1) to finish (8:00 am on day 7) of period in serum thromboxane B2 for each order of drug administration will be primary endpoint of interest.||||>0.05
70965580|NCT00646906|141437135|SUPERIORITY|An analysis of variance, appropriate for a three factor experiment with cohort and dose as non-repeated factors and repeated measure order arranged in a two period cross-over design, was performed.|||||>|0.05|||||||ANOVA|||||||>0.05
70965581|NCT00240981|141437165|SUPERIORITY_OR_OTHER||Mean Difference (Net)|129.8||||0.003|TWO_SIDED|95.0|43.9|215.6||The unadjusted analysis using two-sample Student's t-tests of equal change in the trial groups, allowing unequal variance.|t-test, 2 sided|||||215.6|43.9|0.003
70965582|NCT00240981|141437165|SUPERIORITY_OR_OTHER||Mean Difference (Net)|129.4||||0.004|TWO_SIDED|95.0|43.5|215.4||Adjusted analysis used multiple linear regression, with adjustment for baseline total score on the Short Physical Performance Battery, and self-report of limitations in mobility.|Regression, Linear|||||215.4|43.5|0.004
70965583|NCT00240981|141437166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.5||||0.002|TWO_SIDED|95.0|13.2|55.8||Unadjusted|t-test, 2 sided|||||55.8|13.2|0.002
70965584|NCT00240981|141437166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.5||||0.002|TWO_SIDED|95.0|13.1|56.2||Adjusted|Regression, Linear|||||56.2|13.1|0.002
70965585|NCT00240981|141437167|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.7||||0.34|TWO_SIDED|95.0|-9.2|26.7||Unadjusted|t-test, 2 sided|||||26.7|-9.2|0.34
70965586|NCT00240981|141437167|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.1||||0.37|TWO_SIDED|95.0|-9.9|26.2||Adjusted.|Regression, Linear|||||26.2|-9.9|0.37
70965587|NCT00240981|141437168|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27||||0.69|TWO_SIDED|95.0|-1.1|1.7||Unadjusted|t-test, 2 sided|||||1.7|-1.1|0.69
70965588|NCT00240981|141437168|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.26||||0.71|TWO_SIDED|95.0|-1.1|1.7||Adjusted.|Regression, Linear|||||1.7|-1.1|0.71
70965589|NCT00240981|141437169|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.26|TWO_SIDED|95.0|-0.035|0.135||Unadjusted.|t-test, 2 sided|||||0.135|-0.035|0.26
70965590|NCT00240981|141437169|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.048||||0.27|TWO_SIDED|95.0|-0.037|0.133||Adjusted|Regression, Linear|||||0.133|-0.037|0.27
70965591|NCT00240981|141437170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|30.2||||0.05|TWO_SIDED|95.0|0.3|60.1||Unadjusted.|t-test, 2 sided|||||60.1|0.3|0.05
70965592|NCT00240981|141437170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|29.7||||0.05|TWO_SIDED|95.0|0.2|59.3||Adjusted|Regression, Linear|||||59.3|0.2|0.05
70965593|NCT00240981|141437172|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8||||0.2|TWO_SIDED|95.0|1.2|2.5||Month 3 Measures|t-test, 2 sided|||||2.5|1.2|0.2
70965594|NCT00240981|141437172|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5|||<|0.0001|TWO_SIDED|95.0|0.4|2.2||Month 6 Measures|t-test, 2 sided|||||2.2|0.4|<.0001
70965595|NCT00240981|141437173|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.002|TWO_SIDED|95.0|-2.7|-0.6||3 Months Measures|t-test, 2 sided|||||-0.6|-2.7|0.002
70965596|NCT00240981|141437173|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|||<|0.0001|TWO_SIDED|95.0|-2.8|-1.2||6 Month Measures|t-test, 2 sided|||||-1.2|-2.8|<.0001
70965597|NCT00240981|141437174|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.074||||0.24|TWO_SIDED|95.0|-0.05|0.19||Unadjusted.|t-test, 2 sided|||||0.19|-0.05|0.24
70965598|NCT00240981|141437174|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.14|TWO_SIDED|95.0|-0.03|0.209||Adjusted.|Regression, Linear|||||0.209|-0.030|0.14
70965599|NCT00766090|141437180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108|||<|0.001|TWO_SIDED|95.0|0.064|0.153|||ANCOVA|||||0.153|0.064|<0.001
70965600|NCT00766090|141437180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|||<|0.001|TWO_SIDED|95.0|0.054|0.142|||ANCOVA|||||0.142|0.054|<0.001
70965601|NCT00766090|141437180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087||||0.02|TWO_SIDED|95.0|0.014|0.161|||ANCOVA|||||0.161|0.014|0.020
70965602|NCT00766090|141437180|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the lower limit of the confidence interval (0.025, 1-sided significance level) for the mean difference in trough FEV1 of FF 200 µg OD versus FF 100 µg BID was greater than -110 milliliters.|Mean Difference (Final Values)|0.011||||0.641|TWO_SIDED|95.0|-0.035|0.056|||ANCOVA|||||0.056|-0.035|0.641
70965603|NCT00766090|141437180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|||<|0.001|TWO_SIDED|95.0|0.059|0.205|||ANCOVA|||||0.205|0.059|<0.001
70965604|NCT05417607|141437196|SUPERIORITY||Mean Difference (Net)|3.75|STANDARD_DEVIATION|5.86||0.0047|TWO_SIDED|95.0|1.27|6.22|||t-test, 2 sided|||Within group pre- and post-intervention.||6.22|1.27|0.0047
70965605|NCT05417607|141437197|SUPERIORITY||Mean Difference (Net)|2.21|STANDARD_DEVIATION|7.9||0.2383|TWO_SIDED|95.0|-1.6|6.02|||t-test, 2 sided|||Within group pre- and post-intervention.||6.02|-1.6|0.2383
70965606|NCT05417607|141437198|SUPERIORITY||Mean Difference (Net)|-0.71|STANDARD_DEVIATION|3.58||0.3426|TWO_SIDED|95.0|-2.22|0.8|||t-test, 2 sided|||Within group pre- and post-intervention.||0.80|-2.22|0.3426
70965607|NCT02871778|141437203|SUPERIORITY||Least Square (LS) Mean difference|1.519||||0.0437|TWO_SIDED|95.0|0.044|2.995|||Mixed-effects Model|||||2.995|0.044|0.0437
70965608|NCT02871778|141437203|SUPERIORITY||LS Mean difference|0.04||||0.9755|TWO_SIDED|95.0|-2.509|2.589|||Mixed-effects Model|||||2.589|-2.509|0.9755
70965609|NCT02871778|141437203|SUPERIORITY||LS Mean difference|2.318||||0.0731|TWO_SIDED|95.0|-0.22|4.856|||Mixed-effects Model|||||4.856|-0.22|0.0731
70965610|NCT02871778|141437203|SUPERIORITY||LS Mean Difference|0.799||||0.5373|TWO_SIDED|95.0|-1.751|3.348|||Mixed-effects Model|||||3.348|-1.751|0.5373
70965611|NCT02871778|141437203|SUPERIORITY||LS Mean difference|0.838||||0.453|TWO_SIDED|95.0|-1.368|3.045|||Mixed-effects Model|||||3.045|-1.368|0.453
70965612|NCT02653300|141437212|OTHER|||||||0.03125|||||||Sign test|||||||0.03125
70965613|NCT02170779|141437215|SUPERIORITY_OR_OTHER|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||||||0.84
70965614|NCT02170779|141437216|SUPERIORITY_OR_OTHER|||||||0.738|||||||Wilcoxon (Mann-Whitney)|||||||0.738
70965615|NCT02170779|141437217|SUPERIORITY_OR_OTHER|||||||0.8434|||||||Wilcoxon (Mann-Whitney)|||||||0.8434
70965616|NCT02170779|141437218|SUPERIORITY_OR_OTHER|||||||0.638|||||||Wilcoxon (Mann-Whitney)|||||||0.638
70965617|NCT02170779|141437219|SUPERIORITY_OR_OTHER|||||||0.492|||||||Wilcoxon (Mann-Whitney)|||||||0.492
70965618|NCT02170779|141437220|SUPERIORITY_OR_OTHER|||||||0.144|||||||Wilcoxon (Mann-Whitney)|||This analysis refers to the physical component of the MSIS-29||||0.144
70965619|NCT02170779|141437220|SUPERIORITY_OR_OTHER|||||||0.953|||||||Wilcoxon (Mann-Whitney)|||This refers to the psychological analysis for the MSIS-29.||||0.953
70965620|NCT02170779|141437221|SUPERIORITY_OR_OTHER|||||||0.915|||||||Wilcoxon (Mann-Whitney)|||||||0.915
70965621|NCT02170779|141437222|SUPERIORITY_OR_OTHER|||||||0.023|||||||Wilcoxon (Mann-Whitney)|||||||0.023
70965622|NCT02170779|141437223|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
70965623|NCT00369785|141437224|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62||||||Not adjusted for multiple comparisons.|Mixed Models Analysis|||Null Hypothesis: No difference in immediate recall memory at 24 weeks||||.62
70965624|NCT00369785|141437225|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||||||Not adjusted for multiple comparisons.|Mixed Models Analysis|||Null Hypothesis: No difference in discrimination memory between the two groups||||.007
70965625|NCT00800683|141437226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001||95.0|-0.89|-0.31|||ANCOVA|||For patients who received rescue medication during the course of the trial, the Oracle Clinical (OC) technique was utilised for all efficacy endpoints and the values were set to missing after the rescue medication was administered.||-0.31|-0.89|< 0.0001
70965626|NCT00800683|141437227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001||95.0|-1.03|-0.41|||ANCOVA|||||-0.41|-1.03|< 0.0001
70965627|NCT00800683|141437228|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.9|-0.33|||ANCOVA|||||-0.33|-0.90|< 0.0001
70965628|NCT00800683|141437229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.96|-0.41|||ANCOVA|||||-0.41|-0.96|< 0.0001
70965629|NCT00800683|141437230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001||95.0|-1.05|-0.39|||ANCOVA|||||-0.39|-1.05|< 0.0001
70965630|NCT00800683|141437231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001||95.0|-1.06|-0.44|||ANCOVA|||||-0.44|-1.06|< 0.0001
70965631|NCT00800683|141437232|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001||95.0|-0.96|-0.33|||ANCOVA|||||-0.33|-0.96|< 0.0001
70965632|NCT00800683|141437233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001||95.0|-1.02|-0.44|||ANCOVA|||||-0.44|-1.02|< 0.0001
70965633|NCT00800683|141437234|SUPERIORITY_OR_OTHER|||||||0.1199||95.0||||P-value calculated using a Fisher's exact Test.|Fisher Exact|||||||0.1199
70965634|NCT00800683|141437235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.103||||0.2225||95.0|0.003|3.978|||Regression, Logistic|||Linagliptin vs Placebo. The odds-ratio is based on a logistic regression model including baseline HbA1c, previous anti-diabetic medication and creatinine clearance||3.978|0.003|0.2225
70965635|NCT00800683|141437236|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.816||||0.8927|TWO_SIDED|95.0|0.042|15.756|||Regression, Logistic|||Linagliptin vs Placebo. The odds-ratio is based on a logistic regression model including baseline HbA1c, previous anti-diabetic medication and creatinine clearance||15.756|0.042|0.8927
70965636|NCT00800683|141437237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.73|STANDARD_ERROR_OF_MEAN|11.43||0.8802||95.0|-24.36|20.91|||ANCOVA|||||20.91|-24.36|0.8802
70965637|NCT00800683|141437238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.24|STANDARD_ERROR_OF_MEAN|8.19||0.7848||95.0|-18.47|13.98|||ANCOVA|||||13.98|-18.47|0.7848
70965638|NCT00800683|141437239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.72|STANDARD_ERROR_OF_MEAN|8.09||0.1878||95.0|-26.74|5.31|||ANCOVA|||||5.31|-26.74|0.1878
70965639|NCT00800683|141437240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.42|STANDARD_ERROR_OF_MEAN|7.92||0.5781||95.0|-11.28|20.12|||ANCOVA|||||20.12|-11.28|0.5781
70965640|NCT00800683|141437241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.24|STANDARD_ERROR_OF_MEAN|8.8||0.2954||95.0|-26.67|8.18|||ANCOVA|||||8.18|-26.67|0.2954
70965641|NCT00800683|141437242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.37|STANDARD_ERROR_OF_MEAN|8.27||0.5984||95.0|-12.02|20.75|||ANCOVA|||||20.75|-12.02|0.5984
70965642|NCT00800683|141437243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.07|STANDARD_ERROR_OF_MEAN|8.53||0.4085||95.0|-9.82|23.96|||ANCOVA|||||23.96|-9.82|0.4085
70965643|NCT00800683|141437244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|8.17||0.8698||95.0|-14.84|17.52|||ANCOVA|||||17.52|-14.84|0.8698
70965644|NCT01898689|141437247|EQUIVALENCE|The a priori equivalence region for the difference in means between the two concentrations was specified as +10 mA. This value was considered the minimal clinically relevant current since it approximates the tolerated electrical current range at baseline of the general population-in other words, natural variability and therefore a relatively small amount of current to detect.|Mean Difference (Net)|0.2||||0.02|TWO_SIDED|90.0|-8.2|8.5||"P-values from the TOST procedure were 0.02 and 0.03 for the mean being inside the lower and upper boundaries, respectively.~(estimated mean difference of 0.2 mA; 90% CI 28.2 to 8.5)"|Mixed Models Analysis|||"The null and alternative hypotheses were thus:~H0: m0.1%-m0.4% ≤ -10 or m0.1%-m0.4% ≥ 10 and Ha: -10 , m0.1%-m0.4% , 10 where m0.1% and m0.1% are the population means for tolerance to current under 0.1% and 0.4% ropivacaine, respectively.~With 24 evaluable subjects, we had 90% power at the 0.05 significance level to detect equivalence of 0.1% and 0.4% ropivacaine concentration on the mean tolerance to transcutaneous electrical stimulation"||8.5|-8.2|0.02
70965645|NCT03492554|141437250|OTHER||||||<|0.0001|||||||1 sided exact binomial test|||H0: Specificity = 92% H1: Specificity \> 92 Under the assumption that the true population specificity is 96.5%, 226 subjects who were diagnosed with SR based on the 12-lead ECG reference strip and where the device algorithm classification produced a result of AF or SR was calculated to provide at least 80% power to reject its null hypothesis, using a one-sided type I error of 0.025. To obtain readable waveforms approximately 300 subjects with no known diagnosis of AF were enrolled.||||<0.0001
70965646|NCT03492554|141437251|OTHER||||||<|0.0001|||||||1 sided exact binomial test|||H0: Sensitivity = 90% H1: Sensitivity \> 90% Under the assumption that the true population sensitivity is 95%, 231 subjects who were diagnosed with AF based on the 12-lead ECG reference strip and where the device algorithm classification produced a result of AF or SR was calculated to provide at least 80% power to reject the null hypothesis, using a one-sided type I error of 0.025. To obtain readable waveforms, a minimum of 260 subjects with a known diagnosis of AF were enrolled.||||<0.0001
70965647|NCT03492554|141437252|OTHER||||||<|0.0001|||||||1 sided exact binomial|||H0: agreement proportion of visual display= 0.8 H1: agreement proportion of visual display\> 0.8 Under the assumption that the true population agreement proportion of visual display was 90%, 88 subjects would provide at least 80% power to reject the null hypothesis using a one-sided type I error of 0.05. To account for obtaining readable waveforms, approximately 140 subjects (70 SR; 70 AF) were randomly selected.||||<0.0001
70965648|NCT03492554|141437253|OTHER||||||<|0.0001|||||||1 sided exact binomial|||H0: agreement proportion of R wave amplitude = 0.8 H1: agreement proportion of R wave amplitude \> 0.8 Under the assumption that the true population agreement proportion of R wave amplitude was 90%, 88 subjects would provide at least 80% power to reject the null hypothesis using a one-sided type I error of 0.05. To account for obtaining readable waveforms, approximately 140 subjects (70 SR; 70 AF) were randomly selected.||||<0.0001
70965649|NCT01196533|141437255|SUPERIORITY_OR_OTHER||||||||||||||||||All data in the outcome measure table is presenting the percentage of error.|||
70965650|NCT02463071|141437259|SUPERIORITY||Mean Difference (Final Values)|-26.72|STANDARD_ERROR_OF_MEAN|4.96|<|0.0001|TWO_SIDED|95.0|-36.55|-16.88|||ANCOVA|Baseline TG and statin usage were included as covariates.||||-16.88|-36.55|<0.0001
70965651|NCT02463071|141437259|SUPERIORITY||Mean Difference (Final Values)|-32.92|STANDARD_ERROR_OF_MEAN|5.04|<|0.0001|TWO_SIDED|95.0|-42.93|-22.92|||ANCOVA|Baseline TG and statin usage were included as covariates.||||-22.92|-42.93|<0.0001
70965652|NCT01380730|141437365|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-66.1|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|-71.48|-60.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-60.72|-71.48|<0.001
70965653|NCT01380730|141437365|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.24|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|-65.61|-54.88||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-54.88|-65.61|<0.001
70965654|NCT01380730|141437365|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.82|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|-47.18|-36.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-36.45|-47.18|<0.001
70965655|NCT01380730|141437365|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.33|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|-56.04|-44.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-44.62|-56.04|<0.001
70965656|NCT01380730|141437365|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.0|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-55.69|-44.31||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-44.31|-55.69|<0.001
70965657|NCT01380730|141437365|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.84|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|-47.55|-36.13||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-36.13|-47.55|<0.001
70965658|NCT01380730|141437366|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-79.2|STANDARD_ERROR_OF_MEAN|4.0|<|0.001|TWO_SIDED|95.0|-87.0|-71.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-71.5|-87.0|<0.001
70965659|NCT01380730|141437366|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-77.4|STANDARD_ERROR_OF_MEAN|4.0|<|0.001|TWO_SIDED|95.0|-85.2|-69.6||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-69.6|-85.2|<0.001
70965660|NCT01380730|141437366|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.7|STANDARD_ERROR_OF_MEAN|4.0|<|0.001|TWO_SIDED|95.0|-58.5|-43.0||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-43.0|-58.5|<0.001
70965661|NCT01380730|141437366|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.1|STANDARD_ERROR_OF_MEAN|3.8|<|0.001|TWO_SIDED|95.0|-68.6|-53.7||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-53.7|-68.6|<0.001
70965662|NCT01380730|141437366|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.1|STANDARD_ERROR_OF_MEAN|3.8|<|0.001|TWO_SIDED|95.0|-68.5|-53.7||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-53.7|-68.5|<0.001
70965663|NCT01380730|141437366|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.6|STANDARD_ERROR_OF_MEAN|3.8|<|0.001|TWO_SIDED|95.0|-58.0|-43.1||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-43.1|-58.0|<0.001
70965664|NCT01380730|141437367|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.4|STANDARD_ERROR_OF_MEAN|2.53|<|0.001|TWO_SIDED|95.0|-66.37|-56.43||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-56.43|-66.37|<0.001
70965665|NCT01380730|141437367|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.42|STANDARD_ERROR_OF_MEAN|2.52|<|0.001|TWO_SIDED|95.0|-60.37|-50.47||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-50.47|-60.37|<0.001
70965666|NCT01380730|141437367|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.44|STANDARD_ERROR_OF_MEAN|2.52|<|0.001|TWO_SIDED|95.0|-43.39|-33.48||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-33.48|-43.39|<0.001
70965667|NCT01380730|141437367|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.58|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|-52.72|-42.44||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-42.44|-52.72|<0.001
70965668|NCT01380730|141437367|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.8|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-50.92|-40.67||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-40.67|-50.92|<0.001
70965669|NCT01380730|141437367|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.79|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|-42.94|-32.65||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-32.65|-42.94|<0.001
70965670|NCT01380730|141437368|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.45|STANDARD_ERROR_OF_MEAN|2.46|<|0.001|TWO_SIDED|95.0|-61.28|-51.61||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-51.61|-61.28|<0.001
70965671|NCT01380730|141437368|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.15|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|-54.97|-45.33||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-45.33|-54.97|<0.001
70965672|NCT01380730|141437368|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.74|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|-39.56|-29.92||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-29.92|-39.56|<0.001
70965673|NCT01380730|141437368|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-42.03|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|-47.16|-36.9||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-36.90|-47.16|<0.001
70965674|NCT01380730|141437368|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.77|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-45.88|-35.66||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-35.66|-45.88|<0.001
70965675|NCT01380730|141437368|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.38|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|-39.51|-29.25||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-29.25|-39.51|<0.001
70965676|NCT01380730|141437369|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.74|STANDARD_ERROR_OF_MEAN|2.26|<|0.001|TWO_SIDED|95.0|-52.18|-43.29||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-43.29|-52.18|<0.001
70965677|NCT01380730|141437369|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.38|STANDARD_ERROR_OF_MEAN|2.25|<|0.001|TWO_SIDED|95.0|-47.81|-38.94||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-38.94|-47.81|<0.001
70965678|NCT01380730|141437369|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.4|STANDARD_ERROR_OF_MEAN|2.25|<|0.001|TWO_SIDED|95.0|-35.83|-26.97||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-26.97|-35.83|<0.001
70965679|NCT01380730|141437369|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.65|STANDARD_ERROR_OF_MEAN|2.2|<|0.001|TWO_SIDED|95.0|-39.99|-31.32||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-31.32|-39.99|<0.001
70965680|NCT01380730|141437369|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.97|STANDARD_ERROR_OF_MEAN|2.2|<|0.001|TWO_SIDED|95.0|-40.29|-31.65||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-31.65|-40.29|<0.001
70965681|NCT01380730|141437369|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.73|STANDARD_ERROR_OF_MEAN|2.2|<|0.001|TWO_SIDED|95.0|-32.06|-23.39||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-23.39|-32.06|<0.001
70965682|NCT01380730|141437370|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-53.44|STANDARD_ERROR_OF_MEAN|2.44|<|0.001|TWO_SIDED|95.0|-58.23|-48.65||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-48.65|-58.23|<0.001
70965683|NCT01380730|141437370|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.3|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-52.08|-42.52||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-42.52|-52.08|<0.001
70965684|NCT01380730|141437370|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.75|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-39.53|-29.97||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-29.97|-39.53|<0.001
70965685|NCT01380730|141437370|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-42.93|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-48.36|-37.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-37.50|-48.36|<0.001
70965686|NCT01380730|141437370|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-42.4|STANDARD_ERROR_OF_MEAN|2.75|<|0.001|TWO_SIDED|95.0|-47.81|-36.98||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-36.98|-47.81|<0.001
70965687|NCT01380730|141437370|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.77|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-39.2|-28.33||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-28.33|-39.20|<0.001
70965688|NCT01195090|141437415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.16||0.165|TWO_SIDED|95.0|-0.58|0.08||The change from baseline in A1C were determined using an analysis of co-variance (ANCOVA) model with the factor 'treatment' and baseline A1C as covariate.|ANCOVA|||The change from baseline in A1C were determined using an analysis of co-variance (ANCOVA) model with the factor 'treatment' and baseline A1C as covariate.||0.08|-0.58|0.165
70965689|NCT01195090|141437431|NON_INFERIORITY_OR_EQUIVALENCE|Chi-square test|Chi-Square|0.0034||||0.954||||||Chi-square test|Chi-squared|||Chi-square test for percentages of patient achieving an A1C \<7%||||0.954
70965690|NCT05111041|141437448|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.302|3.309||Not adjusted for multiple outcomes due to exploratory nature of the study.|Regression, Logistic|||||3.309|0.302|1.000
70965691|NCT05111041|141437449|SUPERIORITY||Odds Ratio (OR)|0.8||||0.7389|TWO_SIDED|95.0|0.215|2.972||Not adjusted for multiple outcomes due to exploratory nature of the study.|Regression, Logistic|||||2.972|0.215|0.7389
70965692|NCT05111041|141437451|SUPERIORITY||Odds Ratio (OR)|1.306||||0.6058|TWO_SIDED|95.0|0.474|3.602||Not adjusted for multiple outcomes due to exploratory nature of the study.|Regression, Logistic|||||3.602|0.474|0.6058
70965693|NCT05111041|141437452|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.349|2.866||||||||2.866|0.349|
70965694|NCT05111041|141437453|SUPERIORITY||Odds Ratio (OR)|1.333||||0.5925|TWO_SIDED|95.0|0.465|3.823||Not adjusted for multiple outcomes due to exploratory nature of the study.|Regression, Logistic|||||3.823|0.465|0.5925
70965695|NCT01205230|141437454|SUPERIORITY_OR_OTHER||Ratio of least square geometric means|1.66|||||TWO_SIDED|90.0|1.39|1.99|||||Ratio of least square (LS) geometric means (Pazopanib + Ketoconozole : Pazopanib alone)|||1.99|1.39|
70965696|NCT01205230|141437454|SUPERIORITY_OR_OTHER||Ratio of LS geometric means|0.6|||||TWO_SIDED|90.0|0.52|0.7|||||Ratio of LS geometric means (Pazopanib + Esomeprazole : Pazopanib alone)|||0.70|0.52|
70965697|NCT01205230|141437455|SUPERIORITY_OR_OTHER||Ratio of LS geometric means|1.45|||||TWO_SIDED|90.0|1.14|1.86|||||Ratio of LS geometric means (Pazopanib + Ketoconozole : Pazopanib alone)|||1.86|1.14|
70965698|NCT01205230|141437455|SUPERIORITY_OR_OTHER||Ratio of LS geometric means|0.58|||||TWO_SIDED|90.0|0.5|0.67|||||Ratio of LS geometric means (Pazopanib + Esomeprazole : Pazopanib alone)|||0.67|0.50|
70965699|NCT01205230|141437456|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.45|||||TWO_SIDED|90.0|-1.06|0.06||||||||0.06|-1.06|
70965700|NCT01205230|141437456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07|||||TWO_SIDED|90.0|-0.1|2.44||||||||2.44|-0.10|
70965701|NCT00791258|141437468|SUPERIORITY_OR_OTHER||Percentage|75.8|||||TWO_SIDED|95.0|73.0|78.5||||||||78.5|73.0|
70965702|NCT00791258|141437469|SUPERIORITY_OR_OTHER||Percentage|84.3|||||TWO_SIDED|95.0|81.8|86.5||||||||86.5|81.8|
70965703|NCT00791258|141437470|SUPERIORITY_OR_OTHER||Percentage|71.3|||||TWO_SIDED|95.0|68.3|74.1||||||12 week analysis||74.1|68.3|
70965704|NCT00791258|141437470|SUPERIORITY_OR_OTHER||Percentage|84.8|||||TWO_SIDED|95.0|82.4|87.0||||||20 week analysis||87.0|82.4|
70965705|NCT00791258|141437471|SUPERIORITY_OR_OTHER||Median Difference (Net)|-14.6|||<|0.0001|TWO_SIDED|95.0|-15.4|-13.8|||t-test, 1 sided|||4 week analysis||-13.8|-15.4|<0.0001
70903760|NCT04534114|141296288|OTHER|Fesomersen groups were compared to the placebo group using two-sided log-rank tests. Due to the exploratory nature of these analyses, no multiplicity adjustment was done. Cause-specific hazard ratio and corresponding 2-sided 95% confidence intervals, comparing the hazards for the event-of-interest in each of the Fesomersen groups with the placebo group were estimated based on three separate cause-specific Cox proportional hazards models as exploratory analysis.|Cause specific Hazard ratio|0.91||||0.909|TWO_SIDED|95.0|0.18|4.52|||Log Rank|||||4.52|0.18|0.909
70965706|NCT00791258|141437471|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.6|||<|0.0001|TWO_SIDED|95.0|-17.7|-15.7|||t-test, 1 sided|||8 week analysis||-15.7|-17.7|<0.0001
70965707|NCT00791258|141437471|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.8|||<|0.0001|TWO_SIDED|95.0|-22.7|-20.9|||t-test, 1 sided|||12 week analysis||-20.9|-22.7|<0.0001
70965708|NCT00791258|141437471|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.0|||<|0.0001|TWO_SIDED|95.0|-27.0|-25.0|||t-test, 1 sided|||16 week analysis||-25.0|-27.0|<0.0001
70965709|NCT00791258|141437471|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.8|||<|0.0001|TWO_SIDED|95.0|-27.8|-25.7|||t-test, 1 sided|||20 week analysis||-25.7|-27.8|<0.0001
70965710|NCT00791258|141437472|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.1|||<|0.0001|TWO_SIDED|95.0|-8.6|-7.6|||t-test, 1 sided|||4 week analysis||-7.6|-8.6|<0.0001
70965711|NCT00791258|141437472|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.1|||<|0.0001|TWO_SIDED|95.0|-9.7|-8.5|||t-test, 1 sided|||8 week analysis||-8.5|-9.7|<0.0001
70965712|NCT00791258|141437472|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.9|||<|0.0001|TWO_SIDED|95.0|-12.5|-11.4|||t-test, 1 sided|||12 week analysis||-11.4|-12.5|<0.0001
70965713|NCT00791258|141437472|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.6|||<|0.0001|TWO_SIDED|95.0|-15.2|-14.0|||t-test, 1 sided|||16 week analysis||-14.0|-15.2|<0.0001
70965714|NCT00791258|141437472|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.5||||0.0001|TWO_SIDED|95.0|-15.1|-13.8|||t-test, 1 sided|||20 week analysis||-13.8|-15.1|0.0001
70965715|NCT00791258|141437484|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.8|||<|0.0001|TWO_SIDED|95.0|-16.2|-13.4|||t-test, 1 sided|||Mean 24-hour systolic blood pressure||-13.4|-16.2|<0.0001
70965716|NCT00791258|141437484|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.3|||<|0.0001|TWO_SIDED|95.0|-17.8|-14.8|||t-test, 1 sided|||Mean daytime systolic blood pressure||-14.8|-17.8|<0.0001
70965717|NCT00791258|141437484|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.5|||<|0.0001|TWO_SIDED|95.0|-14.1|-10.8|||t-test, 1 sided|||Mean nighttime systolic blood pressure||-10.8|-14.1|<0.0001
70965718|NCT00791258|141437484|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.6|||<|0.0001|TWO_SIDED|95.0|-15.7|-11.6|||t-test, 1 sided|||systolic blood pressure during last 2 hours of dose||-11.6|-15.7|<0.0001
70965719|NCT00791258|141437484|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.0|||<|0.0001|TWO_SIDED|95.0|-14.7|-11.2|||t-test, 1 sided|||systolic blood pressure during last 4 hours of dose||-11.2|-14.7|<0.0001
70965720|NCT00791258|141437484|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.6|||<|0.0001|TWO_SIDED|95.0|-14.3|-10.9|||t-test, 1 sided|||systolic blood pressure during last 6 hours of dose||-10.9|-14.3|<0.0001
70965721|NCT00791258|141437484|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.4|||<|0.0001||95.0|-10.3|-8.5|||t-test, 1 sided|||Mean 24-hour diastolic blood pressure||-8.5|-10.3|<0.0001
70965722|NCT00791258|141437484|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.6|||<|0.0001|TWO_SIDED|95.0|-11.7|-9.6|||t-test, 1 sided|||Mean daytime diastolic blood pressure||-9.6|-11.7|<0.0001
70965723|NCT00791258|141437484|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.6|||<|0.0001|TWO_SIDED|95.0|-8.8|-6.4|||t-test, 1 sided|||Mean nighttime diastolic blood pressure||-6.4|-8.8|<0.0001
70965724|NCT00791258|141437484|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.6|||<|0.0001||95.0|-10.0|-7.2|||t-test, 1 sided|||diastolic blood pressure during last 2 hours of dose||-7.2|-10.0|<0.0001
70965725|NCT00791258|141437484|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.0|||<|0.0001|TWO_SIDED|95.0|-9.2|-6.8|||t-test, 1 sided|||diastolic blood pressure during last 4 hours of dose||-6.8|-9.2|<0.0001
70965726|NCT00791258|141437484|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.7|||<|0.0001||95.0|-8.8|-6.6|||t-test, 1 sided|||diastolic blood pressure during last 6 hours of dose||-6.6|-8.8|<0.0001
70965727|NCT00791258|141437485|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.0|||<|0.0001|TWO_SIDED|95.0|-22.6|-19.3|||t-test, 1 sided|||24-hour mean systolic blood pressure||-19.3|-22.6|<0.0001
70965728|NCT00791258|141437485|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.2|||<|0.0001|TWO_SIDED|95.0|-25.1|-21.4|||t-test, 1 sided|||Mean daytime systolic blood pressure||-21.4|-25.1|<0.0001
70965729|NCT00791258|141437485|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.5|||<|0.0001|TWO_SIDED|95.0|-19.4|-15.6|||t-test, 1 sided|||Mean nighttime systolic blood pressure||-15.6|-19.4|<0.0001
70965730|NCT00791258|141437485|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.6|||<|0.0001|TWO_SIDED|95.0|-21.7|-17.4|||t-test, 1 sided|||Systolic blood pressure - last 2 hours of dose||-17.4|-21.7|<0.0001
70965731|NCT00791258|141437485|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-18.2|||<|0.0001|TWO_SIDED|95.0|-20.2|-16.3|||t-test, 1 sided|||Systolic blood pressure - last 4 hours of dose||-16.3|-20.2|<0.0001
70965732|NCT00791258|141437485|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.9|||<|0.0001|TWO_SIDED|95.0|-19.7|-16.0|||t-test, 1 sided|||Systolic blood pressure - last 6 hours of dose||-16.0|-19.7|<0.0001
70965733|NCT00791258|141437485|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.3|||<|0.0001|TWO_SIDED|95.0|-14.4|-12.2|||t-test, 1 sided|||24-hour mean diastolic blood pressure||-12.2|-14.4|<0.0001
70965734|NCT00791258|141437485|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.0|||<|0.0001|TWO_SIDED|95.0|-16.2|-13.8|||t-test, 1 sided|||Mean daytime diastolic blood pressure||-13.8|-16.2|<0.0001
70965735|NCT00791258|141437485|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.1|||<|0.0001|TWO_SIDED|95.0|-12.4|-9.8|||t-test, 1 sided|||Mean nighttime diastolic blood pressure||-9.8|-12.4|<0.0001
70903761|NCT03287414|141296295|SUPERIORITY||Least Squares Mean Difference|0.063|STANDARD_ERROR_OF_MEAN|0.1379||0.3248|TWO_SIDED|80.0|-0.115|0.241||1-sided p-values were obtained using MMRM Model.|MMRM|||||0.241|-0.115|0.3248
70903762|NCT03287414|141296296|OTHER|||||||0.868|||||||Log Rank|||||||0.868
70903763|NCT03287414|141296298|OTHER||Hazard Ratio (HR)|2.6||||0.921|TWO_SIDED|80.0|1.1|6.3|||Log Rank|||PFS1||6.3|1.1|0.921
70903764|NCT03287414|141296298|OTHER||Hazard Ratio (HR)|2.2||||0.863|TWO_SIDED|80.0|0.9|5.6|||Log Rank|||PFS2||5.6|0.9|0.863
70903765|NCT03287414|141296299|OTHER||Hazard Ratio (HR)|2.2||||0.863|TWO_SIDED|80.0|0.9|5.6|||Log Rank|||FVC||5.6|0.9|0.863
70903766|NCT03287414|141296299|OTHER||Hazard Ratio (HR)|0.9||||0.457|TWO_SIDED|80.0|0.4|2.0|||Log Rank|||DLCO||2.0|0.4|0.457
70903767|NCT03287414|141296299|OTHER||Hazard Ratio (HR)|0.3||||0.019|TWO_SIDED|80.0|0.1|0.6|||Log Rank|||6MWD||0.6|0.1|0.019
70903768|NCT03287414|141296300|OTHER||Hazard Ratio (HR)|1.1||||0.611|TWO_SIDED|80.0|0.6|2.0|||Log Rank|||Composite Endpoint 1||2.0|0.6|0.611
70903769|NCT03287414|141296300|OTHER||Hazard Ratio (HR)|1.1||||0.549|TWO_SIDED|80.0|0.6|1.9|||Log Rank|||Composite Endpoint 2||1.9|0.6|0.549
70903770|NCT03287414|141296301|SUPERIORITY||Least Squares of the Mean|-0.92|STANDARD_ERROR_OF_MEAN|1.3109||0.7576|TWO_SIDED|80.0|-2.615|0.774||1-sided p-values were obtained using MMRM Model.|MMRM|||||0.774|-2.615|0.7576
70903771|NCT03287414|141296302|SUPERIORITY||Least Squares of the Mean|32.222|STANDARD_ERROR_OF_MEAN|61.8632||0.3018|TWO_SIDED|80.0|-47.572|112.015||1-sided p-values were obtained using MMRM Model.|MMRM|||||112.015|-47.572|0.3018
70903772|NCT03287414|141296303|SUPERIORITY||Least Squares of the Mean|29.166|STANDARD_ERROR_OF_MEAN|60.0143||0.314|TWO_SIDED|80.0|-48.22|106.553||1-sided p-values were obtained using MMRM Model.|MMRM|||||106.553|-48.220|0.3140
70903773|NCT03287414|141296304|SUPERIORITY||Least Squares of the mean|1.77|STANDARD_ERROR_OF_MEAN|1.5422||0.1269|TWO_SIDED|80.0|-0.219|3.759||1-sided p-values were obtained using MMRM Model.|MMRM|||||3.759|-0.219|0.1269
70903774|NCT01087996|141296326|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
70903775|NCT01087996|141296327|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||ANOVA|||||||0.75
70903776|NCT01087996|141296328|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
70903777|NCT01087996|141296329|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
70903778|NCT01087996|141296330|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
70903779|NCT01087996|141296331|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
70903780|NCT01087996|141296332|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Repeated measures ANOVA|||||||0.87
70903781|NCT01087996|141296333|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Repeated measures ANOVA|||||||0.84
70903782|NCT01087996|141296334|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Chi-squared|||||||0.55
70903783|NCT01022073|141296340|SUPERIORITY_OR_OTHER|||||||0.808|||||||t-test, 2 sided|This analysis is based on the completers. We are working on the imputation methods to account for the missing data and will revise results later.||||||0.808
70903784|NCT05067933|141296365|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.953|||||||Wilcoxon rank sum tests|||||||0.953
70903785|NCT05067933|141296366|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.5|||||||Wilcoxon rank sum tests|||||||0.500
70903786|NCT05067933|141296367|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.912|||||||Wilcoxon rank sum tests|||||||0.912
70965736|NCT00791258|141437485|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.3|||<|0.0001|TWO_SIDED|95.0|-13.8|-10.8|||t-test, 1 sided|||Diastolic blood pressure - last 2 hours of dose||-10.8|-13.8|<0.0001
70965737|NCT00791258|141437485|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.6|||<|0.0001|TWO_SIDED|95.0|-12.9|-10.2|||t-test, 1 sided|||Diastolic blood pressure - last 4 hours of dose||-10.2|-12.9|<0.0001
70965738|NCT00791258|141437485|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.3|||<|0.0001|TWO_SIDED|95.0|-12.6|-10.0|||t-test, 1 sided|||Diastolic blood pressure - last 6 hours of dose||-10.0|-12.6|<0.0001
70965739|NCT04784897|141437528|SUPERIORITY||Cox Proportional Hazard|0.9289||||0.7273|TWO_SIDED|90.0|0.6585|1.3102|||Log Rank|||Main comparison is between Brilacidin 5-dose and Pooled Placebo||1.3102|0.6585|0.7273
70965740|NCT04784897|141437528|SUPERIORITY||Cox Proportional Hazard|0.8968||||0.5975|TWO_SIDED|90.0|0.5464|1.472|||Log Rank|||Secondary comparison between Brilacidin 3-dose and Pooled Placebo||1.4720|0.5464|0.5975
70965741|NCT04667377|141437547|OTHER|Covariate adjusted fixed effect estimates of mean percentage change in body weight at Week 46 for each treatment group with associated covariance matrix were extracted from the MMRM (including fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors) and used as input for the MCP-Mod.|||||<|0.0001||||||P-value is adjusted for multiplicity.|MCP-Mod - Linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different potential dose-response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 2.5%).||||<0.0001
70965742|NCT04667377|141437547|OTHER|Covariate adjusted fixed effect estimates of mean percentage change in body weight at Week 46 for each treatment group with associated covariance matrix were extracted from the MMRM (including fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors) and used as input for the MCP-Mod.|||||<|0.0001||||||P-value is adjusted for multiplicity.|MCP-Mod - Exponential model fit|Model Assumption: 50% of maximum effect achieved at dose 3.6 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different potential dose-response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 2.5%).||||<0.0001
70965743|NCT04667377|141437547|OTHER|Covariate adjusted fixed effect estimates of mean percentage change in body weight at Week 46 for each treatment group with associated covariance matrix were extracted from the MMRM (including fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors) and used as input for the MCP-Mod.|||||<|0.0001||||||P-value is adjusted for multiplicity.|MCP-Mod - Emax1 model fit|Model Assumption: 90% of maximum effect achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different potential dose-response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 2.5%).||||<0.0001
70965744|NCT04667377|141437547|OTHER|Covariate adjusted fixed effect estimates of mean percentage change in body weight at Week 46 for each treatment group with associated covariance matrix were extracted from the MMRM (including fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors) and used as input for the MCP-Mod.|||||<|0.0001||||||P-value is adjusted for multiplicity.|MCP-Mod - Emax2 model fit|Model Assumption: 70% of maximum effect achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different potential dose-response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 2.5%).||||<0.0001
70965745|NCT04667377|141437547|OTHER|Covariate adjusted fixed effect estimates of mean percentage change in body weight at Week 46 for each treatment group with associated covariance matrix were extracted from the MMRM (including fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors) and used as input for the MCP-Mod.|||||<|0.0001||||||P-value is adjusted for multiplicity.|MCP-Mod - Sigmoid Emax model fit|Model Assumption: 50% of maximum effect achieved at dose 2.4 mg, 90% of maximum effect achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different potential dose-response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 2.5%).||||<0.0001
70965746|NCT04667377|141437547|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-3.37|STANDARD_ERROR_OF_MEAN|1.5||0.0257|TWO_SIDED|95.0|-6.33|-0.41||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-0.41|-6.33|0.0257
70965747|NCT04667377|141437547|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-9.69|STANDARD_ERROR_OF_MEAN|1.46|<|0.0001|TWO_SIDED|95.0|-12.57|-6.81||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation as used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-6.81|-12.57|<.0001
70965748|NCT04667377|141437547|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-10.4|STANDARD_ERROR_OF_MEAN|1.48|<|0.0001|TWO_SIDED|95.0|-13.32|-7.49||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-7.49|-13.32|<.0001
70965749|NCT04667377|141437547|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-12.12|STANDARD_ERROR_OF_MEAN|1.46|<|0.0001|TWO_SIDED|95.0|-15.0|-9.24||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation will be used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-9.24|-15.00|<.0001
70903787|NCT05067933|141296368|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.678|||||||Wilcoxon rank sum tests|||||||0.678
70903788|NCT05067933|141296369|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.257|||||||Wilcoxon rank sum tests|||||||0.257
70903789|NCT05067933|141296370|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.748|||||||Wilcoxon rank sum tests|||||||0.748
70903790|NCT05067933|141296371|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.946|||||||Wilcoxon rank sum tests|||||||0.946
70903791|NCT05067933|141296374|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.356|||||||Wilcoxon rank sum tests|||||||0.356
70903792|NCT05067933|141296375|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.267|||||||Wilcoxon rank sum tests|||||||0.267
70903793|NCT01065350|141296393|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.87|||<|0.001|TWO_SIDED|95.0|2.07|26.15||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Systolic Blood Pressure (SBP) from baseline to 5 minutes post induction was compared between treatment groups.||26.15|2.07|<0.001
70903794|NCT01065350|141296393|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.24|||<|0.01|TWO_SIDED|95.0|1.21|8.75||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Systolic Blood Pressure (SBP) from baseline to 10 minutes post induction was compared between treatment groups.||8.75|1.21|<0.01
70903795|NCT01065350|141296393|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.39|TWO_SIDED|95.0|0.52|4.55||A p value of \< 0.005 was considered to indicate statistical significance.|Chi-squared|||Systolic Blood Pressure (SBP) from baseline to 30 minutes post induction was compared between treatment groups||4.55|0.52|0.39
70903796|NCT01065350|141296394|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.64|||<|0.01|TWO_SIDED|95.0|1.54|14.92||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Diastolic Blood Pressure (DBP) from baseline to 5 minutes post induction was compared between treatment groups.||14.92|1.54|<0.01
70903797|NCT01065350|141296394|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38||||0.05|TWO_SIDED|95.0|0.91|6.29||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Diastolic Blood Pressure (DBP) from baseline to 10 minutes post induction was compared between treatment groups.||6.29|0.91|0.05
70903798|NCT01065350|141296394|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.74||||0.11|TWO_SIDED|95.0|0.68|13.19||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Diastolic Blood Pressure (DBP) from baseline to 30 minutes post induction was compared between treatment groups.||13.19|0.68|0.11
70903799|NCT01065350|141296395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.12|||<|0.001|TWO_SIDED|95.0|1.98|31.64||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Mean Arterial Pressure (MAP) from baseline to 5 minutes post induction was compared between treatment groups.||31.64|1.98|<0.001
70903800|NCT01065350|141296395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.84||||0.02|TWO_SIDED|95.0|1.07|7.65||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Mean Arterial Pressure (MAP) from baseline to 10 minutes post induction was compared between treatment groups.||7.65|1.07|0.02
70903801|NCT01065350|141296395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.33|TWO_SIDED|95.0|0.51|5.97||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Mean Arterial Pressure (MAP) from baseline to 30 minutes post induction was compared between treatment groups.||5.97|0.51|0.33
70903802|NCT01065350|141296396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.19|TWO_SIDED|95.0|-0.1|0.5|||t-test, 2 sided|||Average change in Cardiac Output (CO) from baseline to 5 minutes post induction was compared between treatment groups.||0.5|-0.1|0.19
70903803|NCT01065350|141296396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.6|TWO_SIDED|95.0|-0.3|0.5|||t-test, 2 sided|||Average change in Cardiac Output (CO) from baseline to 10 minutes post induction was compared between treatment groups.||0.5|-0.3|0.6
70903804|NCT01065350|141296397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.26|TWO_SIDED|95.0|-0.1|0.3|||t-test, 2 sided|||Average change in Cardiac Index (CI) from baseline to 5 minutes post induction was compared between treatment groups.||0.3|-0.1|0.26
70903805|NCT01065350|141296397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.71|TWO_SIDED|95.0|-0.2|0.3|||t-test, 2 sided|||Average change in Cardiac Index (CI) from baseline to 10 minutes post induction was compared between treatment groups.||0.3|-0.2|0.71
70903806|NCT01065350|141296398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.61|TWO_SIDED|95.0|-2.9|1.7|||t-test, 2 sided|||Average heart rate from baseline to 5 minutes post induction was compared between treatment groups.||1.7|-2.9|0.61
70903807|NCT01065350|141296398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.22|TWO_SIDED|95.0|-4.8|1.1|||t-test, 2 sided|||Average heart rate from baseline to 10 minutes post induction was compared between treatment groups.||1.1|-4.8|0.22
70903808|NCT01065350|141296399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.7|||<|0.001|TWO_SIDED|95.0|7.5|20.0|||t-test, 2 sided|||Average change in Systolic Blood Pressure from baseline to 5 minutes post induction was compared between treatment groups.||20.0|7.5|<0.001
70903809|NCT01065350|141296399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.8||||0.017|TWO_SIDED|95.0|0.2|9.5|||t-test, 2 sided|||Average change in Systolic Blood Pressure from baseline to 10 minutes post induction was compared between treatment groups.||9.5|0.2|0.017
70903810|NCT01065350|141296400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|||<|0.01|TWO_SIDED|95.0|2.7|11.5|||t-test, 2 sided|||Average change in Diastolic Blood Pressure from baseline to 5 minutes post induction was compared between treatment groups.||11.5|2.7|<0.01
70903811|NCT01065350|141296400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8||||0.042|TWO_SIDED|95.0|0.2|9.5|||t-test, 2 sided|||Average change in Diastolic Blood Pressure from baseline to 10 minutes post induction was compared between treatment groups.||9.5|0.2|0.042
70903812|NCT01065350|141296401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.4|||<|0.001|TWO_SIDED|95.0|4.8|13.9|||t-test, 2 sided|||Average change in Mean Arterial Pressure (MAP) from baseline to 5 minutes post induction was compared between treatment groups.||13.9|4.8|<0.001
70903813|NCT01065350|141296401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3||||0.013|TWO_SIDED|95.0|1.4|11.3|||t-test, 2 sided|||Average change in Mean Arterial Pressure from baseline to 10 minutes post induction was compared between treatment groups.||11.3|1.4|0.013
70965750|NCT04667377|141437548|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 5% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|3.28||||0.0015|TWO_SIDED|95.0|1.57|6.84||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||6.84|1.57|0.0015
70965751|NCT04667377|141437548|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 5% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|8.83|||<|0.0001|TWO_SIDED|95.0|4.0|19.46||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||19.46|4.00|<.0001
70965752|NCT04667377|141437548|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 5% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|7.48|||<|0.0001|TWO_SIDED|95.0|3.41|16.41||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||16.41|3.41|<.0001
70965753|NCT04667377|141437548|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 5% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|10.77|||<|0.0001|TWO_SIDED|95.0|4.77|24.31||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||24.31|4.77|<.0001
70965754|NCT04667377|141437549|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 10% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|3.22||||0.012|TWO_SIDED|95.0|1.29|8.02||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||8.02|1.29|0.0120
70965755|NCT04667377|141437549|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 10% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|10.62|||<|0.0001|TWO_SIDED|95.0|4.36|25.86||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||25.86|4.36|<.0001
70965756|NCT04667377|141437549|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 10% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|9.78|||<|0.0001|TWO_SIDED|95.0|4.02|23.79||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||23.79|4.02|<.0001
70965757|NCT04667377|141437549|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 10% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|14.5|||<|0.0001|TWO_SIDED|95.0|5.91|35.55||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||35.55|5.91|<.0001
70965758|NCT04667377|141437550|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 15% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|2.13||||0.2654|TWO_SIDED|95.0|0.56|8.02||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||8.02|0.56|0.2654
70965759|NCT04667377|141437550|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 15% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|9.47||||0.0002|TWO_SIDED|95.0|2.89|30.95||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||30.95|2.89|0.0002
70965760|NCT04667377|141437550|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 15% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|11.79|||<|0.0001|TWO_SIDED|95.0|3.62|38.36||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||38.36|3.62|<.0001
70965761|NCT04667377|141437550|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 15% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|21.02|||<|0.0001|TWO_SIDED|95.0|6.47|68.28||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||68.28|6.47|<.0001
70965762|NCT04667377|141437551|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-4.53|STANDARD_ERROR_OF_MEAN|1.48||0.0025|TWO_SIDED|95.0|-7.44|-1.61||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-1.61|-7.44|0.0025
70965763|NCT04667377|141437551|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-12.07|STANDARD_ERROR_OF_MEAN|1.46|<|0.0001|TWO_SIDED|95.0|-14.94|-9.19||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-9.19|-14.94|<.0001
70965764|NCT04667377|141437551|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-12.96|STANDARD_ERROR_OF_MEAN|1.47|<|0.0001|TWO_SIDED|95.0|-15.85|-10.07||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo at week 46.|No formal hypotheses were tested.||-10.07|-15.85|<.0001
70965765|NCT04667377|141437551|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-15.78|STANDARD_ERROR_OF_MEAN|1.47|<|0.0001|TWO_SIDED|95.0|-18.67|-12.9||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo at week 46.|No formal hypotheses were tested.||-12.90|-18.67|<.0001
70965766|NCT04667377|141437552|OTHER|MMRM with fixed effects for baseline waist circumference as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-4.36|STANDARD_ERROR_OF_MEAN|1.71||0.0116|TWO_SIDED|95.0|-7.74|-0.98||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-0.98|-7.74|0.0116
70965767|NCT04667377|141437552|OTHER|MMRM with fixed effects for baseline waist circumference as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-11.03|STANDARD_ERROR_OF_MEAN|1.71|<|0.0001|TWO_SIDED|95.0|-14.39|-7.66||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-7.66|-14.39|<.0001
70965768|NCT04667377|141437552|OTHER|MMRM with fixed effects for baseline waist circumference as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-11.0|STANDARD_ERROR_OF_MEAN|1.69|<|0.0001|TWO_SIDED|95.0|-14.33|-7.67||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-7.67|-14.33|<.0001
70965769|NCT04667377|141437552|OTHER|MMRM with fixed effects for baseline waist circumference as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-12.05|STANDARD_ERROR_OF_MEAN|1.69|<|0.0001|TWO_SIDED|95.0|-15.39|-8.71||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-8.71|-15.39|<.0001
70965770|NCT04667377|141437553|OTHER|MMRM with fixed effects for baseline systolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-3.73|STANDARD_ERROR_OF_MEAN|2.08||0.0733|TWO_SIDED|95.0|-7.82|0.35||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||0.35|-7.82|0.0733
70965771|NCT04667377|141437553|OTHER|MMRM with fixed effects for baseline systolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-5.62|STANDARD_ERROR_OF_MEAN|2.08|<|0.0072|TWO_SIDED|95.0|-9.71|1.53||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||1.53|-9.71|<.0072
70965772|NCT04667377|141437553|OTHER|MMRM with fixed effects for baseline systolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-6.2|STANDARD_ERROR_OF_MEAN|2.05||0.0027|TWO_SIDED|95.0|-10.23|-2.17||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-2.17|-10.23|0.0027
70965773|NCT04667377|141437553|OTHER|MMRM with fixed effects for baseline systolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-6.16|STANDARD_ERROR_OF_MEAN|2.08||0.0033|TWO_SIDED|95.0|-10.25|-2.06||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-2.06|-10.25|0.0033
70965774|NCT04667377|141437554|OTHER|MMRM with fixed effects for baseline diastolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-1.44|STANDARD_ERROR_OF_MEAN|1.26||0.2569|TWO_SIDED|95.0|-3.92|1.05||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||1.05|-3.92|0.2569
70965775|NCT04667377|141437554|OTHER|MMRM with fixed effects for baseline diastolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-2.49|STANDARD_ERROR_OF_MEAN|1.26||0.0495|TWO_SIDED|95.0|-4.97|0.0||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-0.00|-4.97|0.0495
70965776|NCT04667377|141437554|OTHER|MMRM with fixed effects for baseline diastolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-2.44|STANDARD_ERROR_OF_MEAN|1.24||0.0506|TWO_SIDED|95.0|-4.9|0.01||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 -placebo.|No formal hypotheses were tested.||0.01|-4.90|0.0506
70965777|NCT04667377|141437554|OTHER|MMRM with fixed effects for baseline diastolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-2.93|STANDARD_ERROR_OF_MEAN|1.25||0.0202|TWO_SIDED|95.0|-5.4|-0.46||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-0.46|-5.40|0.0202
70965778|NCT01312038|141437565|SUPERIORITY_OR_OTHER||||||=|0.93|||||||Paired T-test|df=34||Comparison of the simethicone and placebo groups with respect to the difference between the pre-post treatment FGE at ME-pressure chamber gradient of -200 daPa.||||=0.93
70965779|NCT01312038|141437565|SUPERIORITY_OR_OTHER||||||=|0.39|||||||Paired T-test|df = 31||Comparison of the simethicone and placebo groups with respect to the difference between the pre-post treatment FGE at ME-pressure chamber gradient of 200 daPa.||||=0.39
70965780|NCT02665052|141437596|SUPERIORITY|||||||0.64||||||The primary analysis was a two sample t-test (alpha=0.05) of the mean WMFT log-time change at 6 weeks. The threshold for statistical significance was p-value = 0.05.|t-test, 2 sided|||78 participants were needed to generate a sample size of 22 per group and provide 80% power to detect a between group difference in mean Wolf time change (6 week - baseline) based on an a priori assumption of a mean change of 0 and 7.4 seconds respectively for the delayed entry usual care control and home-based BATRAC group; a SD of 7.6 and discontinuation rate of 15%.||||0.64
70965781|NCT02665052|141437597|SUPERIORITY|||||||0.01||||||The lab-based group had significant within group mean Fugl-Meyer (FM) change at week 6.|ANOVA|Dunnett's adjustments were used to compare the active intervention changes to the delayed-entry usual care control group.||Within group changes from baseline to week 6 were assessed using analysis of variance.||||0.01
70965782|NCT02665052|141437597|SUPERIORITY|||||||0.97|||||||ANOVA|||FM change was analyzed using analysis of variance followed by Dunnett's adjustment for between group comparisons in the home-based BATRAC group compared to the delayed-entry control.||||0.97
70965783|NCT02665052|141437598|SUPERIORITY|||||||0.31|||||||ANOVA|||Within group SIS hand changes from baseline to week 6 were assessed using analysis of variance followed by comparisons to the delayed-entry usual care control using Dunnett's adjustment.||||0.31
70965784|NCT00823823|141437599|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||The frequency of loss of reduction during the study period was compared across casting groups using a two-sided chi-square test with alpha = 0.05.||||1.00
70965785|NCT04422990|141437613|NON_INFERIORITY|Noninferiority in mean CLCDVA was declared if the upper confidence limit was less than 0.10 logMAR.|Least squares mean difference|0.0|||||TWO_SIDED|95.0|-0.01|0.01||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|Mixed effects repeated measures model||Least squares mean difference (LID018869 minus Biofinity).|||0.01|-0.01|
70965786|NCT04422990|141437614|NON_INFERIORITY|Proportion of subjects was used for the statistical analysis. Noninferiority in proportion of subjects achieving CLCDVA 20/20 or better in each eye was declared if the lower confidence limit was greater than -0.10.|Difference in proportion|-0.01|||||TWO_SIDED|95.0|-0.04|0.02||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|Generalized linear mixed model||Lens difference (LID018869 minus Biofinity)|||0.02|-0.04|
70965787|NCT02790138|141437677|SUPERIORITY||Percentage Difference|21.6||||0.013|TWO_SIDED|95.0|4.9|37.5||The significance level was 0.05.|Fisher's Exact Test|||The Placebo IV and Vedolizumab IV 300 mg groups were analyzed using Fisher's Exact Test at Week 14.||37.5|4.9|0.013
70965788|NCT02790138|141437678|SUPERIORITY||Percentage Difference|17.6|||=|0.043|TWO_SIDED|95.0|0.3|35.1||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Chi-squared Test|||||35.1|0.3|=0.043
70965789|NCT02790138|141437679|SUPERIORITY||Percentage Difference|25.5|||=|0.004|TWO_SIDED|95.0|8.0|41.4||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Fisher's Exact Test|||Week 14||41.4|8.0|=0.004
70965790|NCT02790138|141437679|SUPERIORITY||Percentage Difference|19.6|||=|0.027|TWO_SIDED|95.0|1.9|37.0||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Chi-squared Test|||Week 34.||37.0|1.9|=0.027
70965791|NCT02790138|141437680|SUPERIORITY||Hazard Ratio (HR)|3.95|||||TWO_SIDED|95.0|1.7|9.4|||||Hazard ratio for achieving PDAI remission.|||9.4|1.7|
70965792|NCT02790138|141437681|SUPERIORITY||Percentage Difference|29.4|||=|0.003|TWO_SIDED|95.0|8.0|47.6||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Chi-squared Test|||Week 14||47.6|8.0|=0.003
70965793|NCT02790138|141437681|SUPERIORITY||Percentage Difference|21.6|||=|0.026|TWO_SIDED|95.0|1.9|39.8||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Chi-squared Test|||Week 34||39.8|1.9|=0.026
70965794|NCT02790138|141437682|SUPERIORITY||Odds Estimator|2.02|||=|0.002|TWO_SIDED|95.0|1.11|2.93||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 14||2.93|1.11|=0.002
70965795|NCT02790138|141437682|SUPERIORITY||Odds Estimator|1.71|||=|0.02|TWO_SIDED|95.0|0.92|2.49||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 34||2.49|0.92|=0.020
70965796|NCT02790138|141437683|SUPERIORITY||Odds Estimator|1.34|||=|0.191|TWO_SIDED|95.0|0.74|1.94||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 14||1.94|0.74|=0.191
70965797|NCT02790138|141437683|SUPERIORITY||Odds Estimator|1.07|||=|0.766|TWO_SIDED|95.0|0.6|1.54||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 34||1.54|0.60|=0.766
70965798|NCT02790138|141437684|SUPERIORITY||Odds Estimator|1.57|||=|0.055|TWO_SIDED|95.0|0.83|2.31||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 14||2.31|0.83|=0.055
70965799|NCT02790138|141437684|SUPERIORITY||Odds Estimator|1.48|||=|0.095|TWO_SIDED|95.0|0.79|2.16||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 34||2.16|0.79|=0.095
70965800|NCT02790138|141437685|SUPERIORITY||Odds Estimator|1.14|||=|0.575|TWO_SIDED|95.0|0.61|1.67||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 14||1.67|0.61|=0.575
70965801|NCT02790138|141437685|SUPERIORITY||Odds Estimator|1.21|||=|0.403|TWO_SIDED|95.0|0.65|1.78||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 22||1.78|0.65|=0.403
70965802|NCT02790138|141437685|SUPERIORITY||Odds Estimator|1.6|||=|0.047|TWO_SIDED|95.0|0.85|2.34||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 34||2.34|0.85|=0.047
70965803|NCT02790138|141437686|SUPERIORITY||Odds Estimator|1.44|||=|0.119|TWO_SIDED|95.0|0.77|2.12||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 14||2.12|0.77|=0.119
70965804|NCT02790138|141437686|SUPERIORITY||Odds Estimator|1.15|||=|0.542|TWO_SIDED|95.0|0.62|1.69||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 22||1.69|0.62|=0.542
70965805|NCT02790138|141437686|SUPERIORITY||Odds Estimator|1.22|||=|0.404|TWO_SIDED|95.0|0.65|1.78||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 34||1.78|0.65|=0.404
70965806|NCT01226459|141437694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.1|||<|0.0001|TWO_SIDED|95.0|5.0|13.1|||ANCOVA|P-value is from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.||Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product. Four participants in vehicle group and 3 participants in foam group had no hair information at Baseline. Statistical analysis is of the change from baseline to week 24 data.||13.1|5.0|<0.0001
70965807|NCT01226459|141437695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.8|||<|0.0001|TWO_SIDED|95.0|7.0|14.7|||ANCOVA|P-value is from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.||Statistical analysis is of the change from baseline to week 12 data.||14.7|7.0|<0.0001
70903814|NCT01065350|141296402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|113.6|||<|0.01|TWO_SIDED|95.0|28.1|199.1|||t-test, 2 sided|||Average change in Total Peripheral Resistance (TPR) from baseline to 5 minutes post induction was compared between treatment groups.||199.1|28.1|<0.01
70903815|NCT01065350|141296402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|86.8||||0.12|TWO_SIDED|95.0|-21.7|195.3|||t-test, 2 sided|||Average change in Total Peripheral Resistance (TPR) from baseline to 10 minutes post induction was compared between treatment groups.||195.3|-21.7|0.12
70903816|NCT01065350|141296403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|182.6||||0.017|TWO_SIDED|95.0|33.8|331.3|||t-test, 2 sided|||Average change in Total Peripheral Resistance Index (TPRI) from baseline to 5 minutes post induction was compared between treatment groups.||331.3|33.8|0.017
70903817|NCT01065350|141296403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|128.7||||0.17|TWO_SIDED|95.0|-58.1|315.5|||t-test, 2 sided|||Average change in Total Peripheral Resistance Index (TPRI) from baseline to 10 minutes post induction was compared between treatment groups.||315.5|-58.1|0.17
70903818|NCT01065350|141296404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4||||0.029|TWO_SIDED|95.0|0.5|8.4|||t-test, 2 sided|||Average change in Stroke Volume (SV) from baseline to 5 minutes post induction was compared between treatment groups.||8.4|0.5|0.029
70903819|NCT01065350|141296404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8||||0.051|TWO_SIDED|95.0|0.0|9.7|||t-test, 2 sided|||Average change in Cardiac Index (CI) from baseline to 10 minutes post induction was compared between treatment groups.||9.7|-0.0|0.051
70903820|NCT01065350|141296405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.027|TWO_SIDED|95.0|0.3|4.7|||t-test, 2 sided|||Average change in Stroke Volume Index (SVI) from baseline to 5 minutes post induction was compared between treatment groups.||4.7|0.3|0.027
70903821|NCT01065350|141296405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.052|TWO_SIDED|95.0|0.0|5.2|||t-test, 2 sided|||Average change in Stroke Volume Index (SVI) from baseline to 10 minutes post induction was compared between treatment groups.||5.2|-0.0|0.052
70903822|NCT01065350|141296406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.44|TWO_SIDED|95.0|-1.4|0.6|||t-test, 2 sided|||Average change in Stroke Volume Variation (SVV) from baseline to 5 minutes post induction was compared between treatment groups.||0.6|-1.4|0.44
70903823|NCT01065350|141296406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.37|TWO_SIDED|95.0|-1.6|0.6|||t-test, 2 sided|||Average change in Stroke Volume Variation (SVV) from baseline to 10 minutes post induction was compared between treatment groups.||0.6|-1.6|0.37
70903824|NCT00971750|141296408|SUPERIORITY_OR_OTHER|||||||0.763||95.0|||||Chi-squared|||||||0.763
70903825|NCT00971750|141296410|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
70903826|NCT01657266|141296411|SUPERIORITY_OR_OTHER|||||||1|||||||Pearson´s Chi-square test|||||||1.00
70903827|NCT01316770|141296429|SUPERIORITY|The standard deviation (SD) of the change in salivary flow was assumed to be 0.0168 for the placebo and 0.0906 for the dexamethasone parotid. The within-subject correlation between two glands was assumed to be 0.15. A total of 16 patients would be required to have 80% power to detect a one-sided 40% increase in dexamethasone-irrigated parotid glands compared with the saline irrigated parotid glands with respect to change in salivary flow from Day 0 to Day 56.||||||0.236||||||No corrections were made for multiple comparisons because there was only one primary hypothesis.|one-sided Paired t-test|||The mixed models analysis included all time points but it failed to converge. Therefore, an alternative analysis was performed using a paired t-test. Because the Satterthwaite correction \[that was specified in the statistical analysis plan (SAP) for the mixed model\] is not available for the paired t-test, it was not performed on the paired t-test. The final analysis was based upon the raw non-transformed saliva flow rates, as these measures were appropriate for the model used.||||0.236
70903828|NCT01316770|141296430|SUPERIORITY|||||||0.662|||||||one-sided paired t-test|||The mixed models analysis (including all time points: study days 14, 28, 42, 56) failed to converge; thus, an alternative analysis, as stated in the Statistical Analysis Plan, was performed using the paired t-test. The Satterthwaite correction (Statistical Analysis Plan) is not available for the paired t-test and was not performed on the paired t-test. The final analysis was based upon the raw non-transformed saliva flow rates since this statistical model achieved the best fit to the data.||||0.662
70903829|NCT01316770|141296431|SUPERIORITY|||||||0.607|||||||one-sided paired t-test|||The mixed models analysis (including all time points: study days 14, 28, 42, 56) failed to converge; thus, an alternative analysis, as stated in the Statistical Analysis Plan, was performed using the paired t-test. The Satterthwaite correction (Statistical Analysis Plan) is not available for the paired t-test and was not performed on the paired t-test. The final analysis was based upon the raw non-transformed saliva flow rates since this statistical model achieved the best fit to the data.||||0.607
70903830|NCT01316770|141296432|SUPERIORITY|||||||0.586|||||||one-sided paired t-test|||The mixed models analysis (including all time points: study days 14, 28, 42, 56) failed to converge; thus, an alternative analysis, as stated in the Statistical Analysis Plan, was performed using the paired t-test. The Satterthwaite correction (Statistical Analysis Plan) is not available for the paired t-test and was not performed on the paired t-test. The final analysis was based upon the raw non-transformed saliva flow rates since this statistical model achieved the best fit to the data.||||0.586
70903831|NCT01316770|141296446|OTHER|||||||0.5|||||||McNemar|||"McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 14 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 14.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 14 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 14."||||0.500
70965808|NCT01226459|141437696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|||<|0.0001|TWO_SIDED|95.0|0.35|1.04|||ANCOVA|||||1.04|0.35|<0.0001
70965809|NCT03770091|141437699|SUPERIORITY|ANOVA performed||||||0.6|||||||ANOVA|||||||0.6
70965810|NCT03770091|141437700|SUPERIORITY|||||||0.59|||||||ANOVA|||||||0.59
70965811|NCT03770091|141437701|SUPERIORITY|||||||0.9|||||||ANOVA|||||||0.9
70965812|NCT03770091|141437702|SUPERIORITY|||||||0.45|||||||ANCOVA|||||||0.45
70965813|NCT03770091|141437703|SUPERIORITY|||||||0.5|||||||ANOVA|||||||0.5
70965814|NCT01092143|141437738|SUPERIORITY||Adjusted mean treatment differences|3.083|STANDARD_DEVIATION|1.65||0.0311|TWO_SIDED|95.0|-0.157|6.323||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 50 mg b.i.d. compared with those treated with placebo, after 6 weeks.||6.323|-0.157|0.0311
70965815|NCT01092143|141437738|SUPERIORITY||Adjusted mean treatment differences|3.589|STANDARD_DEVIATION|1.6||0.0126|TWO_SIDED|95.0|0.447|6.732||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, trea||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 200 mg b.i.d. compared with those treated with placebo, after 6 weeks.||6.732|0.447|0.0126
70965816|NCT01092143|141437738|SUPERIORITY||Adjusted mean treatment differences|3.977|STANDARD_DEVIATION|1.64||0.0078|TWO_SIDED|95.0|0.756|7.197||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 400 mg b.i.d. compared with those treated with placebo, after 6 weeks.||7.197|0.756|0.0078
70965817|NCT01092143|141437738|OTHER||Adjusted mean treatment differences|8.619|STANDARD_DEVIATION|1.684|<|0.0001|TWO_SIDED|95.0|5.312|11.927||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with fluticasone propionate 110 mcg 2 puffs b.i.d. compared with those treated with placebo, after 6 weeks.||11.927|5.312|<.0001
70965818|NCT01092143|141437738|SUPERIORITY||Adjusted mean treatment differences|-5.536|STANDARD_DEVIATION|1.653||0.9996|TWO_SIDED|95.0|-8.783|-2.29||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 50 mg b.i.d. compared with those treated with fluticasone propionate 220 mcg b.i.d., after 6 weeks.||-2.290|-8.783|0.9996
70965819|NCT01092143|141437738|SUPERIORITY||Adjusted mean treatment differences|-5.03|STANDARD_DEVIATION|1.606||0.9991|TWO_SIDED|95.0|-8.185|-1.875||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 200 mg b.i.d. compared with those treated with fluticasone propionate 220mcg b.i.d., after 6 weeks.||-1.875|-8.185|0.9991
70965820|NCT01092143|141437738|SUPERIORITY||Adjusted mean treatment differences|-4.643|STANDARD_DEVIATION|1.647||0.9975|TWO_SIDED|95.0|-7.877|-1.408||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 400 mg b.i.d. compared with those treated with fluticasone propionate 220 mcg b.i.d., after 6 weeks.||-1.408|-7.877|0.9975
70965821|NCT01092143|141437739|SUPERIORITY||Adjusted mean treatment differences|0.073|STANDARD_DEVIATION|0.113||0.7413|TWO_SIDED|95.0|-0.149|0.295||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.295|-0.149|0.7413
70965822|NCT01092143|141437739|SUPERIORITY||Adjusted mean treatment differences|-0.08|STANDARD_DEVIATION|0.11||0.2335|TWO_SIDED|95.0|-0.296|0.136||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.136|-0.296|0.2335
70965823|NCT01092143|141437739|SUPERIORITY||Adjusted mean treatment differences|-0.061|STANDARD_DEVIATION|0.113||0.2933|TWO_SIDED|95.0|-0.282|0.16||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.160|-0.282|0.2933
70965824|NCT01092143|141437739|SUPERIORITY||Adjusted mean treatment differences|-0.333|STANDARD_DEVIATION|0.116||0.0021|TWO_SIDED|95.0|-0.561|-0.105||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||-0.105|-0.561|0.0021
70965825|NCT01092143|141437739|SUPERIORITY||Adjusted mean treatment differences|0.406|STANDARD_DEVIATION|0.114||0.9998|TWO_SIDED|95.0|0.183|0.63||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.630|0.183|0.9998
70965826|NCT01092143|141437739|SUPERIORITY||Adjusted mean treatment differences|0.253|STANDARD_DEVIATION|0.11||0.989|TWO_SIDED|95.0|0.037|0.47||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.470|0.037|0.9890
70965827|NCT01092143|141437739|SUPERIORITY||Adjusted mean treatment differences|0.272|STANDARD_DEVIATION|0.113||0.9918|TWO_SIDED|95.0|0.05|0.494||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.494|0.050|0.9918
70965828|NCT02774616|141437752|NON_INFERIORITY|A rejection of the null hypothesis (Ho) would demonstrate evidence that the complication-free rate is greater than 90.0% in the population.||||||0.0004|||||||exact binomial|||"Serious Adverse Device Effects (SADE) possibly or securely related to the Ilivia ICD family until the 3- month follow-up are counted for this primary endpoint. The following hypothesis has been defined:~Ho: SADE-free rate through 3 months post-implant ≤ 90.0% Ha: SADE-free rate through 3 months post-implant \> 90.0%"||||0.0004
70965829|NCT02774616|141437753|NON_INFERIORITY|A rejection of the null hypothesis (Ho) would demonstrate evidence that the complication-free rate is greater than 90.0% in the population.||||||0.0019|||||||exact binomial|||"Serious Adverse Device Effects (SADE) possibly or securely related to the Plexa ICD lead until the 6-month follow-up are counted for this primary endpoint. The following hypothesis has been defined:~Ho: SADE-free rate through 3 months post-implant ≤ 90.0% Ha: SADE-free rate through 3 months post-implant \> 90.0%"||||0.0019
70965830|NCT02774616|141437755|NON_INFERIORITY|This endpoint evaluates the rate of appropriate right ventricular sensing of all patients in which a sensing measurement was performed. The following hypothesis has been defined: Ho: Rate of appropriate sensing through 3 months post-implant ≤ 93.0% Ha: Rate of appropriate sensing through 3 months post-implant \> 93.0%|||||<|0.0001||||||A rejection of the null hypothesis (Ho) would demonstrate evidence that the rate of appropriate sensing is greater than 93.0% in the population.|exact binomial|||||||<0.0001
70965831|NCT02774616|141437756|NON_INFERIORITY|A rejection of the null hypothesis (Ho) would demonstrate evidence that the rate of appropriate pacing is greater than 93.0% in the population.|||||<|0.0001|||||||exact binomial|||"This secondary hypothesis evaluates the rate of appropriate right ventricular pacing of all patients in which a pacing measurement was performed. The following hypothesis has been defined:~Ho: Rate of appropriate pacing through 3 months post-implant ≤ 93.0% Ha: Rate of appropriate pacing through 3 months post-implant \> 93.0%"||||<0.0001
70965832|NCT00397033|141437758|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|P-value is based on the CMH chi-square test with modified ridit scores, stratified by concomitant medication stratum, and country.||||||0.001
70965833|NCT00397033|141437758|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Cochran-Mantel-Haenszel|P-value is based on the CMH chi-square test with modified ridit scores, stratified by concomitant medication stratum, and country.||||||0.008
70965834|NCT00397033|141437759|SUPERIORITY_OR_OTHER||LS Means Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.9|<|0.001||95.0|-5.1|-1.7|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-1.7|-5.1|<0.001
70965835|NCT00397033|141437759|SUPERIORITY_OR_OTHER||LS Means Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.9||0.217||95.0|-2.8|0.6|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.6|-2.8|0.217
70965836|NCT00397033|141437760|SUPERIORITY_OR_OTHER||LS Means Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.6||0.108||95.0|-2.3|0.2|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.2|-2.3|0.108
70965837|NCT00397033|141437760|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.6||0.43||95.0|-1.7|0.7|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.7|-1.7|0.430
70965838|NCT00397033|141437761|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|1.5||0.008||95.0|-6.7|-1.0|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-1.0|-6.7|0.008
70965839|NCT00397033|141437761|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.4||0.175||95.0|-4.8|0.9|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.9|-4.8|0.175
70965840|NCT00397033|141437762|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.9||0.001||95.0|-4.6|-1.1|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-1.1|-4.6|0.001
70965841|NCT00397033|141437762|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.9||0.209||95.0|-2.8|0.6|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.6|-2.8|0.209
70965842|NCT00397033|141437764|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.6||0.032||95.0|-6.5|-0.3|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-0.3|-6.5|0.032
70965843|NCT00397033|141437764|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|1.5||0.013||95.0|-6.8|-0.8|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-0.8|-6.8|0.013
70965844|NCT00397033|141437765|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.232||95.0|-2.0|0.5|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.5|-2.0|0.232
70965845|NCT00397033|141437765|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.6||0.31||95.0|-1.8|0.6|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.6|-1.8|0.310
70965846|NCT00397033|141437766|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.6||0.004||95.0|-3.1|-0.6|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-0.6|-3.1|0.004
70965847|NCT00397033|141437766|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.269||95.0|-1.9|0.5|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.5|-1.9|0.269
70965848|NCT00397033|141437767|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.6|<|0.001||95.0|-3.2|-1.0|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-1.0|-3.2|<0.001
70965849|NCT00397033|141437767|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.6||0.314||95.0|-1.7|0.5|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.5|-1.7|0.314
70965850|NCT00397033|141437768|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.5||0.071||95.0|-1.8|0.1|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.1|-1.8|0.071
70965851|NCT00397033|141437768|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.5||0.099||95.0|-1.7|0.1|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.1|-1.7|0.099
70965852|NCT00397033|141437770|SUPERIORITY_OR_OTHER||LS Means Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2|<|0.001||95.0|-0.9|-0.3|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-0.3|-0.9|<0.001
70965853|NCT00397033|141437770|SUPERIORITY_OR_OTHER||LS Means Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.083||95.0|-0.6|0.0|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.0|-0.6|0.083
70965854|NCT00397033|141437771|SUPERIORITY_OR_OTHER||LS Means Difference|-8.3|STANDARD_ERROR_OF_MEAN|2.8||0.003||95.0|-13.8|-2.9||The Hochberg step-up procedure was used to address multiplicity.|ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|One of the primary pairwise comparisons was paliperidone ER high dose vs. placebo. The Hochberg step-up procedure was used to address multiplicity. P-value for between treatment group comparisons is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.||-2.9|-13.8|0.003
70965855|NCT00397033|141437771|SUPERIORITY_OR_OTHER||LS Means Difference|-3.6|STANDARD_ERROR_OF_MEAN|2.7||0.187||95.0|-9.0|1.8||The Hochberg step-up procedure was used to address multiplicity.|ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|One of the primary pairwise comparisons was paliperidone ER low dose vs. placebo. The Hochberg step-up procedure was used to address multiplicity. P-value for between treatment group comparisons is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.||1.8|-9.0|0.187
70965856|NCT00397033|141437772|SUPERIORITY_OR_OTHER||LS Means Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001||95.0|-1.1|-0.4|||ANOVA|P-value is from an ANOVA model with fixed-effects for treatment, concomitant medication stratum and country.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher Scores indicate worsening.|||-0.4|-1.1|<0.001
70965857|NCT00397033|141437772|SUPERIORITY_OR_OTHER||LS Means Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.029||95.0|-0.7|0.0|||ANOVA|P-value is from an ANOVA model with fixed-effects for treatment, concomitant medication stratum and country.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.0|-0.7|0.029
70965858|NCT00397033|141437774|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|1.6|<|0.001||95.0|-9.9|-3.7|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-3.7|-9.9|<0.001
70965859|NCT00397033|141437774|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|1.5||0.066||95.0|-5.8|0.2|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.2|-5.8|0.066
70965860|NCT01984164|141437775|SUPERIORITY||Treatment effect size|-13.6|||||TWO_SIDED|95.0|-23.6|-3.7|||||effect size p-value = 0.008|All analyses were conducted using the intention-to-treat principle. Results are provided as adjusted least-square means with SE and effect size (ES) estimates (calculated from mixed model with repeated measures (MMRM) as the adjusted difference in cognitive change between the 2 groups over the study period).||-3.7|-23.6|
70965861|NCT05293743|141437790|EQUIVALENCE|This analysis uses Welch's t-tests to calculate statistical significance, given the different variances and sample sizes of the populations.||||||0.67||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of Freedom = 3.82.||The null hypothesis is that there is no difference in brace adherence fractions between the control arm and the experimental arm during the study's intervention period. In this test, brace wear was measured by parent-reported brace logs.||||0.67
70965862|NCT05293743|141437790|EQUIVALENCE|This analysis uses Welch's t-tests to calculate statistical significance, given the different variances and sample sizes of the populations.||||||0.23||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of Freedom = 3.70.||The null hypothesis is that there is no difference in brace adherence fractions between the control arm and the experimental arm during the study's intervention period. In this test, brace wear was measured by iButton temperature sensors.||||0.23
70965863|NCT05293743|141437791|EQUIVALENCE|This analysis uses Welch's t-tests to calculate statistical significance, given the different variances and sample sizes of the populations.||||||0.86||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of Freedom = 6.68.||The null hypothesis is that there is no difference in brace adherence fractions when the experimental arm is wearing the Dynamic Bar versus the Standard Bar during the study period. In this test, brace wear was measured by parent-reported brace logs.||||0.86
70965864|NCT05293743|141437791|EQUIVALENCE|This analysis uses Welch's t-tests to calculate statistical significance, given the different variances and sample sizes of the populations.||||||0.21||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of Freedom = 6.94.||The null hypothesis is that there is no difference in brace adherence fractions when the experimental arm is wearing the Dynamic Bar versus the Standard Bar during the study period. In this test, brace wear was measured by iButton temperature sensors.||||0.21
70965865|NCT02064920|141437804|SUPERIORITY_OR_OTHER||Change in SD from Week 4 to Week 16|0.005|||||TWO_SIDED|95.0|-0.031|0.039|||||SD of average OCL repeated measurements after 12 weeks of treatment for Placebo + Donezepil treatment groups combined is hypothesized to be ≤ 0.1.|Change from Week 4 to Week 16 in Standard Deviation (SD) of OCL for Placebo + Donezepil treatment groups combined||0.039|-0.031|
70965866|NCT02229539|141437831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Wilcoxon rank-sum|||||||0.02
70965867|NCT02229539|141437831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Wilcoxon rank-sum|||||||0.004
70965868|NCT03227471|141437848|OTHER|||||||0.9943||||||P value within treatment|Mixed-effects model for repeated measure|||||||0.9943
70965869|NCT03227471|141437848|OTHER||||||<|0.0001||||||P value within treatment|Mixed-effects model for repeated measure|||||||<0.0001
70965870|NCT03227471|141437848|OTHER||||||<|0.0001||||||P value within treatment|Mixed-effects model for repeated measure|||||||< 0.0001
70965871|NCT03227471|141437848|OTHER||||||<|0.0001||||||P value within treatment|Mixed-effects model for repeated measure|||||||<0.0001
70965872|NCT03227471|141437849|OTHER|||||||0.8869||||||P value within treatment.|Mixed-effects model for repeated measure|||||||0.8869
70965873|NCT03227471|141437849|OTHER||||||<|0.0001||||||P value within treatment|Mixed-effects model for repeated measure|||||||<0.0001
70965874|NCT03227471|141437850|OTHER|||||||0.6407||||||P value within treatment|Mixed-effects model for repeated measure|||||||0.6407
70965875|NCT03227471|141437850|OTHER||||||<|0.0001||||||P value within treatment.|mixed-effects model for repeated measure|||||||<0.0001
70965876|NCT03227471|141437865|OTHER|||||||0.5802||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||0.5802
70965877|NCT03227471|141437865|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
70965878|NCT03227471|141437865|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
70965879|NCT03227471|141437865|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
70965880|NCT03227471|141437866|OTHER|||||||0.8712||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||0.8712
70965881|NCT03227471|141437866|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||<0.0001
70965882|NCT03227471|141437867|OTHER|||||||0.8359||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||0.8359
70965883|NCT03227471|141437867|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||<0.0001
70965884|NCT03227471|141437868|OTHER|||||||0.9453||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||0.9453
70965885|NCT03227471|141437868|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
70965886|NCT03227471|141437868|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
70965887|NCT03227471|141437868|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
70965888|NCT03227471|141437869|OTHER|||||||0.7849||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||0.7849
70965889|NCT03227471|141437869|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||<0.0001
70965890|NCT03227471|141437870|OTHER|||||||0.7356||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||0.7356
70965891|NCT03227471|141437870|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||<0.0001
70965892|NCT03227471|141437871|OTHER|||||||0.394||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||0.3940
70965893|NCT03227471|141437871|OTHER|||||||0.0003||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||0.0003
70965894|NCT03227471|141437871|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
70965895|NCT03227471|141437871|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
70965896|NCT03227471|141437872|OTHER|||||||0.4757||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||0.4757
70965897|NCT03227471|141437872|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||<0.0001
70965898|NCT03227471|141437873|OTHER|||||||0.007||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||0.0070
70965899|NCT03227471|141437873|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||<0.0001
70965900|NCT00257166|141437883|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|-5.22|STANDARD_ERROR_OF_MEAN|1.48||0.0005|TWO_SIDED|95.0|-8.12|-2.31|||ANCOVA|||Change at Week 4: Mixed effects repeated measures Analysis of Covariance (ANCOVA) model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-2.31|-8.12|0.0005
70965901|NCT00257166|141437884|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.2545|STANDARD_ERROR_OF_MEAN|0.9422||0.0006|TWO_SIDED|95.0|-5.1045|-1.4046|||ANCOVA|||Change at Week 1: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-1.4046|-5.1045|0.0006
70965902|NCT00257166|141437884|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.5857|STANDARD_ERROR_OF_MEAN|1.4184||0.0117|TWO_SIDED|95.0|-6.3705|-0.8009|||ANCOVA|||Change at Week 2: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-0.8009|-6.3705|0.0117
70965903|NCT00257166|141437884|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.8665|STANDARD_ERROR_OF_MEAN|1.7154||0.0047|TWO_SIDED|95.0|-8.2345|-1.4985|||ANCOVA|||Change at Week 3: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-1.4985|-8.2345|0.0047
70965904|NCT00257166|141437885|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3754|STANDARD_ERROR_OF_MEAN|0.0989||0.0002|TWO_SIDED|95.0|-0.5696|-0.1812|||ANCOVA|||Change at Week 1: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-0.1812|-0.5696|0.0002
70965905|NCT00257166|141437885|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.5596|STANDARD_ERROR_OF_MEAN|0.1355|<|0.0001|TWO_SIDED|95.0|-0.8256|-0.2936|||ANCOVA|||Change at Week 2: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-0.2936|-0.8256|<0.0001
70965906|NCT00257166|141437885|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.6798|STANDARD_ERROR_OF_MEAN|0.1643|<|0.0001|TWO_SIDED|95.0|-1.0024|-0.3572|||ANCOVA|||Change at Week 3: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-0.3572|-1.0024|<0.0001
70965907|NCT00257166|141437885|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.6884|STANDARD_ERROR_OF_MEAN|0.1761||0.0001|TWO_SIDED|95.0|-1.0342|-0.3426|||ANCOVA|||Change at Week 4: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-0.3426|-1.0342|0.0001
70965908|NCT00257166|141437886|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.21||0.0004|TWO_SIDED|95.0|-1.18|-0.34|||ANCOVA|||Week 4: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects was used for the analysis.||-0.34|-1.18|0.0004
70965909|NCT04050670|141437893|NON_INFERIORITY|A priori estimates for the 90% CI geometric least square means ratios of AUC(0-∞) for the thigh versus abdomen injection sites were from 0.80 to 1.25|Ratio of geometric least squares mean|0.953|||||TWO_SIDED|90.0|0.935|0.97|||Linear mixed effects model|||||0.970|0.935|
70965910|NCT04050670|141437893|NON_INFERIORITY|A priori estimates for the 90% CI geometric least square means ratios of AUC(0-∞) for the upper arm versus abdomen injection sites were from 0.80 to 1.25.|Ratio of geometric least squares mean|0.99|||||TWO_SIDED|90.0|0.972|1.01|||Linear mixed effects model|||||1.01|0.972|
70965911|NCT04050670|141437894|NON_INFERIORITY|A priori estimates for the 90% CI geometric least square means ratios of Cmax for thigh versus abdomen injection sites were from 0.80 to 1.25.|Ratio of geometric least squares mean|0.862|||||TWO_SIDED|90.0|0.818|0.909|||Linear mixed effects model|||||0.909|0.818|
70965912|NCT04050670|141437894|NON_INFERIORITY|A priori estimates for the 90% CI geometric least square means ratios of Cmax for the upper arm versus abdomen injection sites were from 0.80 to 1.25.|Ratio of geometric least squares mean|0.921|||||TWO_SIDED|95.0|0.874|0.971|||Linear mixed effects model|||||0.971|0.874|
70965913|NCT00525044|141437943|OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.028||0.0156|TWO_SIDED|95.0|-0.12|-0.01|||ANOVA||Treatment differences (Ambroxol- Placebo)|"Differences between the treatment groups with regard to the primary endpoint SPIDnorm was tested using an analysis of variance (ANOVA) including treatment and centre as fix effects.~Treatment differences were estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||-0.01|-0.12|0.0156
70965914|NCT00525044|141437944|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.128|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo)|"Analysis at 30 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||0|-0.4|0.1280
70965915|NCT00525044|141437944|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0417|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo)|"Analysis at 60 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||0.0|-0.4|0.0417
70965916|NCT00525044|141437944|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0054|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA||Treatment differences (Ambroxol- Placebo|"Analysis at 120 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||-0.1|-0.6|0.0054
70965917|NCT00525044|141437944|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0201|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo|"Analysis at 180 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||0.0|-0.6|0.0201
70965918|NCT00525044|141437945|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.128|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo)|"Analysis at 30 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||0.0|-0.4|0.1280
70965919|NCT00525044|141437945|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0417|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo|"Analysis at 60 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||0.0|-0.4|0.0417
70965920|NCT00525044|141437945|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0054|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA||Treatment differences (Ambroxol- Placebo|"Analysis at 120 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||-0.1|-0.6|0.0054
70965921|NCT00525044|141437945|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0201|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo|"Analysis at 180 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||0.0|-0.6|0.0201
70965922|NCT00525044|141437946|OTHER|||||||0.9939|||||||Mantel Haenszel|||"Analysis at day 1:~P-value was calculated by the Cochran-Mantel-Haenszel test adjusting for center."||||0.9939
70965923|NCT00525044|141437946|OTHER|||||||0.5552|||||||Mantel Haenszel|||"Analysis at day 2:~P-value was calculated by the Cochran-Mantel-Haenszel test adjusting for center."||||0.5552
70965924|NCT00525044|141437947|OTHER|||||||0.0343|||||||Mantel Haenszel|||"Analysis at day 1:~P-value was calculated by the Cochran-Mantel-Haenszel test adjusting for center."||||0.0343
70965925|NCT00525044|141437947|OTHER|||||||0.0119|||||||Mantel Haenszel|||"Analysis at day 2:~P-value was calculated by the Cochran-Mantel-Haenszel test adjusting for center."||||0.0119
70965926|NCT00713817|141437990|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.89||||0.273|TWO_SIDED|95.0|-0.78|2.56|||ANCOVA|||The two groups were compared using Analysis of Covariance (ANCOVA) with baseline severity as a covariate and study centre group and treatment group as factors. Due to the low power of the test for interaction the test was performed at the 10% level of significance and a 95% confidence interval (CI) was presented for the difference between treatments.||2.56|-0.78|0.273
70965927|NCT00713817|141437991|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|4.62||||0.296|TWO_SIDED|95.0|-4.51|13.75|||ANCOVA|||The two groups were compared using Analysis of Covariance (ANCOVA) with baseline severity as a covariate and study centre group and treatment group as factors. Due to the low power of the test for interaction the test was performed at the 10% level of significance and a 95% confidence interval (CI) was presented for the difference between treatments.||13.75|-4.51|0.296
70965928|NCT00713817|141437992|SUPERIORITY_OR_OTHER_LEGACY||Chi-square|0.048||||0.826||95.0|||||Log Rank|||Time to treatment failure was analysed using Kaplan-Meier Survival analysis methodology. The difference in loss of response cumulative distribution function between treatments was assessed using the Hodges-Lehmann estimate.||||0.826
70965929|NCT00713817|141437993|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-7.14||||0.54|TWO_SIDED|95.0|-39.7|9.62|||Hodges-Lehmann|||The difference in loss of response cumulative distribution functions between treatments was assessed using the Wilcoxon test with an estimate of the median difference between groups in response level (percent change from baseline) provided by the Hodges-Lehmann estimator.||9.62|-39.7|0.54
70965930|NCT00713817|141437994|SUPERIORITY_OR_OTHER_LEGACY||Estimate mean treatment difference|-0.08||||0.902|TWO_SIDED|95.0|-1.45|1.29|||ANCOVA|||The two groups were compared using Analysis of Covariance (ANCOVA) with baseline severity as a covariate and study centre group and treatment group as factors. Due to the low power of the test for interaction the test was performed at the 10% level of significance and a 95% confidence interval (CI) was presented for the difference between treatments.||1.29|-1.45|0.902
70965931|NCT00713817|141437995|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.557||||0.603|TWO_SIDED|95.0|0.293|8.261|||Regression, Logistic|||The two treatment groups were compared using ordinal logistic regression and the proportional odds model. The model incorporated the parent Randomised Controlled Trials (RCTs). The interaction between treatment group and parent RCTs was investigated, but was dropped from the model if found to have little influence. The test was performed at the 10% significance level. The final model was then treatment group and parent RCTs, i.e. the treatment effect was adjusted for parent RCTs baseline.||8.261|0.293|0.603
70965932|NCT04415658|141438005|SUPERIORITY||Risk Ratio (RR)|1.01||||0.57|TWO_SIDED|95.0|0.97|1.07|||Chi-squared, Corrected|||80% power to detect a 10% increase in hearts transplanted||1.07|0.97|0.57
70965933|NCT04415658|141438006|NON_INFERIORITY|Six percent margin, assuming 96% graft survival in control group|Mean Difference (Final Values)|1.9|||<|0.001|TWO_SIDED|95.0|-2.3|6.0|||Regression, Logistic|||Non-inferiority analysis for thyroxine vs saline||6.0|-2.3|<0.001
70965934|NCT00514514|141438105|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.56|||<|0.0001|TWO_SIDED|95.0|2.82|8.31|||ANCOVA|||||8.31|2.82|< 0.0001
70965935|NCT01101438|141438164|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.93|TWO_SIDED|95.0|0.84|1.21|||Log Rank|||||1.21|0.84|0.93
70965936|NCT01101438|141438165|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.94|TWO_SIDED|95.0|0.87|1.17|||Log Rank|||||1.17|0.87|0.94
70965937|NCT01101438|141438166|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.88|TWO_SIDED|95.0|0.83|1.24|||Log Rank|||||1.24|0.83|0.88
70965938|NCT00303979|141438172|SUPERIORITY_OR_OTHER||Relative Improvement (%)|8.4|||<|0.001|TWO_SIDED|95.0|7.0|9.7|||a large sample test (z-test)|||Performance Measure #1: relative change in % of eligible patients treated with angiotensin converting enzyme inhibitor and/or angiotensin II receptor blockers (ACEU/ARB).||9.7|7.0|<0.001
70965939|NCT00303979|141438172|SUPERIORITY_OR_OTHER||Relative improvement (%)|8.6|||<|0.001|TWO_SIDED|95.0|7.7|9.6|||a large sample test (z-test)|||Performance Measure #2: relative change in % of eligible patients treated with beta-blockers.||9.6|7.7|<0.001
70965940|NCT00303979|141438172|SUPERIORITY_OR_OTHER||Relative improvement (%)|79.7|||<|0.001|TWO_SIDED|95.0|70.5|89.0|||a large sample test (z-test)|||Performance Measure #3: relative change in % of eligible patients treated with aldosterone receptor antagonists.||89.0|70.5|<0.001
70965941|NCT00303979|141438172|SUPERIORITY_OR_OTHER||Relative Improvement (%)|1.0||||0.546|TWO_SIDED|95.0|-2.2|4.2|||a large sample test (z-test)|||Performance Measure #4: relative change in % of eligible patients treated with anticoagulation for AF.||4.2|-2.2|0.546
70965942|NCT00303979|141438172|SUPERIORITY_OR_OTHER||Relative Improvement (%)|81.9|||<|0.001|TWO_SIDED|95.0|72.2|91.7|||a large sample test (z-test)|||Performance Measure #5: relative change in % of eligible patients treated with cardiac resynchronization therapy (CRT-P/CRT-D).||91.7|72.2|<0.001
70965943|NCT00303979|141438172|SUPERIORITY_OR_OTHER||Relative Improvement (%)|62.1|||<|0.001|TWO_SIDED|95.0|59.1|65.1|||a large sample test (z-test)|||Performance Measure #6: relative change in % of eligible patients treated with implantable cardioverter-defibrillator (ICD) or CRT-D.||65.1|59.1|<0.001
70965944|NCT00303979|141438172|SUPERIORITY_OR_OTHER||Relative Improvement (%)|14.7|||<|0.001|TWO_SIDED|95.0|12.6|16.8|||a large sample test (z-test)|||Performance Measure #7: relative change in % of eligible patients with HF education.||16.8|12.6|<0.001
70965945|NCT00303979|141438174|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|19.4||||0.004|TWO_SIDED|95.0|-1.1|39.8|||t-test, 2 sided|||Performance Measure #1: Relative change at 24 months compared with baseline in ACEI/ARB for the aggregate practices.||39.8|-1.1|0.004
70965946|NCT00303979|141438174|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|7.6|||<|0.001|TWO_SIDED|95.0|5.1|10.2|||t-test, 2 sided|||Performance Measure #2: the relative change at 24 months compared with baseline in beta-blockers for the aggregate practices.||10.2|5.1|<0.001
70903832|NCT01316770|141296446|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 28 is equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 28 is not equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28."||||1.000
70965947|NCT00303979|141438174|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|30.0|||<|0.001|TWO_SIDED|95.0|24.6|35.5|||t-test, 2 sided|||Performance Measure #3: the relative change at 24 months compared with baseline in aldosterone antagonist for the aggregate practices.||35.5|24.6|<0.001
70965948|NCT00303979|141438174|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|1.0||||0.513||95.0|-3.6|5.5|||t-test, 2 sided|||Performance Measure #4: the relative change at 24 months compared with baseline in anticoagulation for AF for the aggregate practices.||5.5|-3.6|0.513
70965949|NCT00303979|141438174|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|48.4|||<|0.001|TWO_SIDED|95.0|37.9|58.8|||t-test, 2 sided|||Performance Measure #5: the relative change at 24 months compared with baseline in CRT-P/CRT-D for the aggregate practices.||58.8|37.9|<0.001
70965950|NCT00303979|141438174|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|70.9|||<|0.001|TWO_SIDED|95.0|61.0|80.8|||t-test, 2 sided|||Performance Measure #6: the relative change at 24 months compared with baseline in ICD/CRT-D for the aggregate practices.||80.8|61.0|<0.001
70965951|NCT00303979|141438174|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|50.6|||<|0.001|TWO_SIDED|95.0|27.1|74.2|||t-test, 2 sided|||Performance Measure #7: the relative change at 24 months compared with baseline in HF education for the aggregate practices.||74.2|27.1|<0.001
70965952|NCT00303979|141438174|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|19.2|||<|0.001|TWO_SIDED|95.0|16.3|22.0|||t-test, 2 sided|||Composite Score: The relative change at 24 months compared with baseline in composite score for the aggregate practices.||22.0|16.3|<0.001
70965953|NCT00303979|141438175|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|10.3||||0.197|TWO_SIDED|95.0|-5.4|25.9|||t-test, 2 sided|||Performance Measure #1: the relative change of Cohort B (6 months) compared with Cohort A at baseline in ACEI/ARB for the aggregate practices.||25.9|-5.4|0.197
70965954|NCT00303979|141438175|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|10.6||||0.061|TWO_SIDED|95.0|-0.5|21.7|||t-test, 2 sided|||Performance Measure #2: the relative change of Cohort B (6 months) compared with Cohort A at baseline in beta-blockers for the aggregate practices.||21.7|-0.5|0.061
70965955|NCT00303979|141438175|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|-1.1||||0.622|TWO_SIDED|95.0|-5.7|3.4|||t-test, 2 sided|||Performance Measure #3: the relative change of Cohort B (6 months) compared with Cohort A at baseline in aldosterone antagonist for the aggregate practices.||3.4|-5.7|0.622
70965956|NCT00303979|141438175|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|6.2||||0.05|TWO_SIDED|95.0|0.0|12.4|||t-test, 2 sided|||Performance Measure #4: the relative change of Cohort B (6 months) compared with Cohort A at baseline in anticoagulation for AF for the aggregate practices.||12.4|0.0|0.05
70965957|NCT00303979|141438175|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|-1.8||||0.711|TWO_SIDED|95.0|-11.2|7.7|||t-test, 2 sided|||Performance Measure #5: the relative change of Cohort B (6 months) compared with Cohort A at baseline in CRT-P/CRT-D for the aggregate practices.||7.7|-11.2|0.711
70965958|NCT00303979|141438175|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|14.4|||<|0.001|TWO_SIDED|95.0|6.9|22.0|||t-test, 2 sided|||Performance Measure #6: the relative change of Cohort B (6 months) compared with Cohort A at baseline in ICD/CRT-D for the aggregate practices.||22.0|6.9|<0.001
70965959|NCT00303979|141438175|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|38.5|||<|0.001|TWO_SIDED|95.0|23.2|53.8|||t-test, 2 sided|||Performance Measure #7: the relative change of Cohort B (6 months) compared with Cohort A at baseline in HF education for the aggregate practices.||53.8|23.2|<0.001
70965960|NCT00303979|141438175|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|6.6|||<|0.001|TWO_SIDED|95.0|4.2|9.0|||t-test, 2 sided|||Composite Score: the relative change of Cohort B (6 months) compared with Cohort A at baseline in composite score for the aggregate practices.||9.0|4.2|<0.001
70965961|NCT00303979|141438176|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|10.5||||0.19|TWO_SIDED|95.0|-5.3|26.3|||t-test, 2 sided|||Performance Measure #1: the relative change of Cohort C (18 months) compared with Cohort A at baseline in ACEI/ARB for the aggregate practices.||26.3|-5.3|0.190
70965962|NCT00303979|141438176|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|14.3||||0.048|TWO_SIDED|95.0|0.1|28.4|||t-test, 2 sided|||Performance Measure #2: the relative change of Cohort C (18 months) compared with Cohort A at baseline in beta-blockers for the aggregate practices.||28.4|0.1|0.048
70965963|NCT00303979|141438176|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|5.8||||0.24|TWO_SIDED|95.0|-3.9|15.4|||t-test, 2 sided|||Performance Measure #3: the relative change of Cohort C (18 months) compared with Cohort A at baseline in aldosterone antagonist for the aggregate practices.||15.4|-3.9|0.240
70965964|NCT00303979|141438176|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|6.7||||0.033|TWO_SIDED|95.0|0.5|13.0|||t-test, 2 sided|||Performance Measure #4: the relative change of Cohort C (18 months) compared with Cohort A at baseline in anticoagulation for AF for the aggregate practices.||13.0|0.5|0.033
70965965|NCT00303979|141438176|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|9.3||||0.085|TWO_SIDED|95.0|-1.3|19.8|||t-test, 2 sided|||Performance Measure #5: the relative change of Cohort C (18 months) compared with Cohort A at baseline in CRT-P/CRT-D for the aggregate practices.||19.8|-1.3|0.085
70965966|NCT00303979|141438176|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|17.6|||<|0.001|TWO_SIDED|95.0|9.3|25.8|||t-test, 2 sided|||Performance Measure #6: the relative change of Cohort C (18 months) compared with Cohort A at baseline in ICD/CRT-D for the aggregate practices.||25.8|9.3|<0.001
70965967|NCT00303979|141438176|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|59.5|||<|0.001|TWO_SIDED|95.0|33.9|85.2|||t-test, 2 sided|||Performance Measure #7: the relative change of Cohort C (18 months) compared with Cohort A at baseline in HF education for the aggregate practices.||85.2|33.9|<0.001
70965968|NCT00303979|141438176|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|10.6|||<|0.001|TWO_SIDED|95.0|7.6|13.6|||t-test, 2 sided|||Composite Score: the relative change of Cohort C (18 months) compared with Cohort A at baseline in composite score for the aggregate practices.||13.6|7.6|<0.001
70965969|NCT01750931|141438178|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Percent ratio|102.45||||0.4396|TWO_SIDED|95.0|99.4|105.59|||ANOVA|||||105.59|99.40|0.4396
70965970|NCT01750931|141438180|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Percent ratio|105.02||||0.9712|TWO_SIDED|95.0|99.69|110.63|||ANOVA||Comparison of AUC0-t between group GSK-meloxicam 15 mg and Mobic-meloxicam 15 mg|||110.63|99.69|0.9712
70965971|NCT01750931|141438180|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Percent ratio|102.31||||0.9951|TWO_SIDED|95.0|99.05|105.69|||ANOVA||Comparison of AUC0-infinity between group GSK-meloxicam 15 mg and Mobic-meloxicam 15 mg|||105.69|99.05|0.9951
70965972|NCT01843972|141438209|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|97.88|STANDARD_DEVIATION|24.8|||TWO_SIDED|90.0|79.963|119.809|||ANOVA||The geometric mean ratio is calculated as the geometric mean of 'BI 691751 tablet extensive metabolizers (part II)' divided by the geometric mean of 'BI 691751 solution (part II)'.|Only extensive CYP2D6 metabolisers were selected: 12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)' and 7 (all investigated) subjects of group 'BI 691751 solution (part II) '.||119.809|79.963|
70965973|NCT01843972|141438209|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|111.2|STANDARD_DEVIATION|24.7|||TWO_SIDED|90.0|88.596|139.576|||ANOVA||The geometric mean ratio was calculated as the geometric mean of the poor metabolisers divided by the geometric mean of the extensive metabolisers.|Comparison of poor metabolisers (5 (all) subjects of group 'BI 691751 tablet poor metabolizers (part II)') and extensive metabolisers (12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)').||139.576|88.596|
70965974|NCT01843972|141438210|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|101.31|STANDARD_DEVIATION|28.2|||TWO_SIDED|90.0|80.593|127.351|||ANOVA||The geometric mean ratio is calculated as the geometric mean of 'BI 691751 tablet extensive metabolizers (part II)' divided by the geometric mean of 'BI 691751 solution (part II)'.|Only extensive CYP2D6 metabolisers were selected: 12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)' and 7 (all investigated) subjects of group 'BI 691751 solution (part II) '.||127.351|80.593|
70965975|NCT01843972|141438210|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|92.69|STANDARD_DEVIATION|33.0|||TWO_SIDED|90.0|68.662|125.119|||ANOVA||The geometric mean ratio was calculated as the geometric mean of the poor metabolisers divided by the geometric mean of the extensive metabolisers.|Comparison of poor metabolisers (5 (all) subjects of group 'BI 691751 tablet poor metabolizers (part II)') and extensive metabolisers (12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)').||125.119|68.662|
70965976|NCT01843972|141438211|NON_INFERIORITY_OR_EQUIVALENCE|This was non-confirmatory testing.|Slope|1.0233|||||TWO_SIDED|95.0|0.8265|1.2201|||Regression, Linear|||||1.2201|0.8265|
70965977|NCT01843972|141438212|NON_INFERIORITY_OR_EQUIVALENCE|This was non-confirmatory testing.|Slope|0.9686|||||TWO_SIDED|95.0|0.8107|1.1266|||Regression, Linear|||Dose proportionality of BI 691751 was explored using a power model (regression model applied to log-transformed data).||1.1266|0.8107|
70965978|NCT01843972|141438213|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|95.48|STANDARD_DEVIATION|30.8|||TWO_SIDED|90.0|74.414|122.511|||ANOVA||The geometric mean ratio is calculated as the geometric mean of 'BI 691751 tablet extensive metabolizers (part II)' divided by the geometric mean of 'BI 691751 solution (part II)'.|Only extensive CYP2D6 metabolisers were selected: 12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)' and 7 (all investigated) subjects of group 'BI 691751 solution (part II) '.||122.511|74.414|
70965979|NCT01843972|141438213|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|109.8|STANDARD_DEVIATION|28.8|||TWO_SIDED|90.0|84.376|142.894|||ANOVA||The geometric mean ratio was calculated as the geometric mean of the poor metabolisers divided by the geometric mean of the extensive metabolisers.|Comparison of poor metabolisers (5 (all) subjects of group 'BI 691751 tablet poor metabolizers (part II)') and extensive metabolisers (12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)').||142.894|84.376|
70965980|NCT01843972|141438213|NON_INFERIORITY_OR_EQUIVALENCE|This was non-confirmatory testing.|Slope|1.0312|||||TWO_SIDED|95.0|0.833|1.179|||Regression, Linear|||||1.1790|0.833|
70965981|NCT01854645|141438233|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 5 min post dose||||<0.0001
70965982|NCT01854645|141438233|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 15 min post dose||||<0.0001
70965983|NCT01854645|141438233|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 5 min post dose||||<0.0001
70903833|NCT01316770|141296446|OTHER|||||||0.5|||||||McNemar|||"McNemar's test on the study Day 42 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 42 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 42.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 42 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 42."||||0.500
70903834|NCT01316770|141296446|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 56 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 56 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 56.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 56 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 56."||||1.000
70903835|NCT01316770|141296448|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 14 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 14.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 14 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 14."||||1.000
70903836|NCT01316770|141296448|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 28 is equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 28 is not equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28."||||1.000
70903837|NCT01316770|141296449|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 14 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 14.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 14 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 14."||||1.000
70903838|NCT01316770|141296449|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 28 is equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 28 is not equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28."||||1.000
70903839|NCT01316770|141296449|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 42 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 42 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 42.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 42 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 42."||||1.000
70903840|NCT01316770|141296449|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 56 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 56 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 56.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 56 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 56."||||1.000
70903841|NCT01316770|141296452|OTHER|||||||0.25|||||||McNemar|||"McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 14 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 14.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 14 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 14."||||0.250
70903842|NCT01316770|141296452|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 28 is equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 28 is not equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28."||||1.000
70903843|NCT01316770|141296452|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 42 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 42 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 42.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 42 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 42."||||1.000
70903844|NCT01316770|141296452|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 56 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 56 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 56.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 56 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 56."||||1.000
70903845|NCT01316770|141296453|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 14 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 14.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 14 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 14."||||1.000
70965984|NCT01854645|141438233|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 15 min post dose||||<0.0001
70965985|NCT01854645|141438233|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 5 min post dose||||<0.0001
70965986|NCT01854645|141438233|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 15 min post dose||||<0.0001
70965987|NCT03086265|141438235|OTHER|||||||0.7934|||||||t-test, 2 sided|||||||0.7934
70965988|NCT03086265|141438244|OTHER|||||||0.6876|||||||t-test, 2 sided|||||||0.6876
70965989|NCT03086265|141438245|OTHER|||||||0.7549|||||||t-test, 2 sided|||||||0.7549
70965990|NCT03086265|141438246|OTHER|||||||0.6479|||||||t-test, 2 sided|||||||0.6479
70965991|NCT03086265|141438247|OTHER|||||||0.8322|||||||t-test, 2 sided|||||||0.8322
70965992|NCT03086265|141438249|OTHER|||||||0.0058|||||||t-test, 2 sided|||||||0.0058
70965993|NCT03086265|141438250|OTHER|||||||0.3346|||||||t-test, 2 sided|||||||0.3346
70965994|NCT03086265|141438251|OTHER|||||||0.5513|||||||t-test, 2 sided|||||||0.5513
70965995|NCT03086265|141438252|OTHER|||||||0.1927|||||||t-test, 2 sided|||||||0.1927
70965996|NCT03086265|141438253|OTHER|||||||0.6483|||||||t-test, 2 sided|||||||0.6483
70965997|NCT03086265|141438254|OTHER|||||||0.5625|||||||t-test, 2 sided|||||||0.5625
70965998|NCT03086265|141438255|OTHER|||||||0.2827|||||||t-test, 2 sided|||||||0.2827
70965999|NCT03086265|141438256|OTHER|||||||0.8426|||||||t-test, 2 sided|||||||0.8426
70966000|NCT03086265|141438257|OTHER|||||||0.9856|||||||t-test, 2 sided|||||||0.9856
70966001|NCT03086265|141438258|OTHER|||||||0.8112|||||||t-test, 2 sided|||||||0.8112
70966002|NCT03086265|141438259|OTHER|||||||0.6587|||||||t-test, 2 sided|||||||0.6587
70966003|NCT03086265|141438260|OTHER|||||||0.4143|||||||t-test, 2 sided|||||||0.4143
70966004|NCT03086265|141438261|OTHER|||||||0.4324|||||||t-test, 2 sided|||||||0.4324
70966005|NCT03086265|141438262|OTHER|||||||0.7221|||||||t-test, 2 sided|||Comparison of preoperative scores.||||0.7221
70966006|NCT03086265|141438262|OTHER|||||||0.0336|||||||t-test, 2 sided|||Comparison of postoperative scores.||||0.0336
70966007|NCT01202279|141438263|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025||95.0|||||Fisher Exact|||||||0.025
70966008|NCT01202279|141438264|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0|||||ANCOVA|||||||0.022
70966009|NCT02109562|141438292|SUPERIORITY||Mean Difference (Final Values)|-6.148|STANDARD_ERROR_OF_MEAN|1.7261||0.0004|TWO_SIDED|95.0|-9.982|-2.314||For evaluation of treatment differences, compare against a 1-sided adjusted P value with significance at \<0.025. The P values have been adjusted for multiple comparisons using Dunnett's procedure.|repeated measure linear regression model||RBP-7000 90 mg - Placebo|Estimates, standard errors (SE), 2-sided confidence intervals (CIs), and -1-sided P values are based on a repeated-measures linear regression model of the change from baseline score, with fixed effects for visit as a categorical variable, baseline score, treatment and treatment by visit interaction, assuming an unstructured covariance matrix.||-2.314|-9.982|0.0004
70966010|NCT02109562|141438292|SUPERIORITY||Mean Difference (Final Values)|-7.237|STANDARD_ERROR_OF_MEAN|1.7141|<|0.0001|TWO_SIDED|95.0|-11.045|-3.429||For evaluation of treatment differences, compare against a 1-sided adjusted P value with significance at \<0.025. The P values have been adjusted for multiple comparisons using Dunnett's procedure.|repeated measure linear regression model||RBP-7000 120 mg - Placebo|Estimates, standard errors (SE), 2-sided confidence intervals (CIs), and -1-sided P values are based on a repeated-measures linear regression model of the change from baseline score, with fixed effects for visit as a categorical variable, baseline score, treatment and treatment by visit interaction, assuming an unstructured covariance matrix.||-3.429|-11.045|<0.0001
70966011|NCT02109562|141438293|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.0934||0.0002|TWO_SIDED|95.0|-0.557|-0.143||For evaluation of treatment differences, compare against a 1-sided adjusted P value with significance at \<0.025. The P values have been adjusted for multiple comparisons using Dunnett's procedure.|repeated measure linear regression model||RBP-7000 90 mg - Placebo|Estimates, standard errors (SE), 2-sided confidence intervals (CIs), and -1-sided P values are based on a repeated-measures linear regression model of the change from baseline score, with fixed effects for visit as a categorical variable, baseline score, treatment and treatment by visit interaction, assuming an unstructured covariance matrix.||-0.143|-0.557|0.0002
70966012|NCT02109562|141438293|SUPERIORITY||Mean Difference (Final Values)|-0.396|STANDARD_ERROR_OF_MEAN|0.0928|<|0.0001|TWO_SIDED|95.0|-0.602|-0.19||For evaluation of treatment differences, compare against a 1-sided adjusted P value with significance at \<0.025. The P values have been adjusted for multiple comparisons using Dunnett's procedure.|repeated measure linear regression model||RBP-7000 120 mg - Placebo|Estimates, standard errors (SE), 2-sided confidence intervals (CIs), and -1-sided P values are based on a repeated-measures linear regression model of the change from baseline score, with fixed effects for visit as a categorical variable, baseline score, treatment and treatment by visit interaction, assuming an unstructured covariance matrix.||-0.190|-0.602|<0.0001
70966013|NCT00688155|141438304|EQUIVALENCE|Two-sided test of mean differences from baseline.|Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.25||0.66|TWO_SIDED|||||Physical activity training versus no physical activity training;|ANOVA|||Marginal comparisons of physical activity training vs no physical activity training||||0.66
70966014|NCT00688155|141438304|EQUIVALENCE|Two-sided tests of mean differences from baseline.|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.26||0.55|TWO_SIDED|||||P-value for physical activity training is 0.55|ANOVA|||Marginal comparisons of physical activity training versus no physical activity training||||0.55
70966015|NCT00688155|141438304|EQUIVALENCE|Two Sided Test of Mean Difference from baseline|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.25||0.95|TWO_SIDED||||||ANOVA|||Marginal comparisons of cognitive training versus no cognitive training||||0.95
70966016|NCT00688155|141438304|EQUIVALENCE|Two Sided Test of Mean Difference from baseline|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.26||0.48|TWO_SIDED||||||ANOVA|||Marginal comparisons of cognitive training versus no cognitive training||||0.48
70966017|NCT00688155|141438306|EQUIVALENCE|Two-sided tests of marginal means|Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.29||0.23|TWO_SIDED||||||ANOVA|||Marginal comparisons of physical activity training versus no physical activity training.||||0.23
70966018|NCT00688155|141438306|EQUIVALENCE|Two Sided Test of Mean Difference from baseline|Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.29||0.42|TWO_SIDED||||||ANOVA|||Marginal comparisons of cognitive training versus no cognitive training||||0.42
70966019|NCT02142738|141438375|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.37|0.68||One-sided p-value based on log-rank test|Regression, Cox|Treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous)||||0.68|0.37|<0.001
70966020|NCT02142738|141438376|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.002|TWO_SIDED|95.0|0.47|0.86||One-sided p-value based on log-rank test|Regression, Cox|Treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous)||||0.86|0.47|0.002
70966021|NCT02142738|141438377|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentages|16.6||||0.0011|TWO_SIDED|95.0|6.0|27.0||One-sided p-value for testing|Miettinen & Nurminem method|Stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous)||H0: difference in %=0 vs. H1: difference in % \>0||27.0|6.0|0.0011
70966022|NCT01858532|141438388|OTHER||||||=|0.029|||||||Stratified log-rank test|||The endpoint was analyzed using the stratified log-rank test for treatment comparison.||||=0.029
70966023|NCT01858532|141438388|OTHER||Hazard Ratio (HR)|0.654|||=|0.005|TWO_SIDED|95.0|0.488|0.878|||Regression, Cox|||A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.||0.878|0.488|=0.005
70966024|NCT01858532|141438389|OTHER||||||=|0.289|||||||Stratified log-rank test|||The endpoint was analyzed using the stratified log-rank test for treatment comparison.||||=0.289
70966025|NCT01858532|141438389|OTHER||Hazard Ratio (HR)|0.779||||0.112|TWO_SIDED|95.0|0.573|1.06|||Regression, Cox|||A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.||1.060|0.573|0.112
70966026|NCT01858532|141438390|OTHER|||||||0.089|||||||Stratified log-rank test|||The endpoint was analyzed using the stratified log-rank test for treatment comparison.||||0.089
70966027|NCT01858532|141438390|OTHER||Hazard Ratio (HR)|0.801||||0.049|TWO_SIDED|95.0|0.642|0.999|||Regression, Cox|||A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.||0.999|0.642|0.049
70966028|NCT01858532|141438391|OTHER||Hazard Ratio (HR)|0.72||||0.002|TWO_SIDED|95.0|0.58|0.89|||Regression, Cox|||A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.||0.89|0.58|0.002
70966029|NCT01858532|141438392|OTHER|||||||0.446|||||||Stratified log-rank test|||The endpoint was analyzed using the stratified log-rank test for treatment comparison.||||0.446
70966030|NCT01858532|141438392|OTHER||Hazard Ratio (HR)|0.884||||0.447|TWO_SIDED|95.0|0.643|1.215|||Regression, Cox|||A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.||1.215|0.643|0.447
70966031|NCT01488279|141438403|SUPERIORITY||Mean Difference (Net)|-10.8|STANDARD_ERROR_OF_MEAN|480.8||0.983|TWO_SIDED|95.0|-1147.6|1126.0|||ANOVA|||2X2 crossover design with baseline values. To compare the means between Sitagliptin and Placebo, a sequential three step testing process used. The results of the third step, the direct treatment comparisons are presented.||1126.0|-1147.6|.983
70966032|NCT01488279|141438406|SUPERIORITY||Mean Difference (Net)|-0.008|STANDARD_ERROR_OF_MEAN|1.935||0.997|TWO_SIDED|95.0|-4.585|4.568|||ANOVA|||||4.568|-4.585|.997
70966033|NCT01488279|141438407|SUPERIORITY||Mean Difference (Net)|-38.9|STANDARD_ERROR_OF_MEAN|49.9||0.46|TWO_SIDED|95.0|-156.9|79.0|||ANOVA|||||79.0|-156.9|.460
70966034|NCT00674583|141438411|NON_INFERIORITY|Criterion for non-inferiority evaluation: The lower limit (LL) of the two-sided standardized asymptotic 95% CI for the group difference (Nimenrix Group minus Menjugate Group) in the percentages of subjects with vaccine response to rSBA-MenC is greater than or equal to (≥) the pre-defined clinical limit of -10%.|Difference in percentage|-0.88|||||TWO_SIDED|95.0|-5.25|5.75||||||To demonstrate the non-inferiority of the Nimenrix group compared to the Menjugate group, two-sided standardized asymptotic 95% confidence interval (CI) for the groups difference \[Nimenrix group minus Menjugate group\] in the percentages of subjects with bactericidal vaccine response to MenC was computed.||5.75|-5.25|
70966035|NCT02234284|141438430|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.35|TWO_SIDED|95.0|-0.15|0.43|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||.43|-.15|.35
70966036|NCT02234284|141438431|SUPERIORITY||Mean Difference (Net)|0.26||||0.2|TWO_SIDED|95.0|-0.13|0.65|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||.65|-.13|.20
70966037|NCT02234284|141438432|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.13|TWO_SIDED|95.0|-0.49|0.07|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for rate of exacerbations for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||0.07|-0.49|.13
70966038|NCT02234284|141438433|SUPERIORITY||Mean Difference (Final Values)|8.53||||0.32|TWO_SIDED|95.0|-8.18|25.26|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.||Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.|Value is for mean distance (in meters) of participants in Health Coached arm minus mean distance in Usual Care, adjusted for baseline values and for clustering.|25.26|-8.18|.32
70966039|NCT02234284|141438434|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.27|TWO_SIDED|95.0|-0.23|0.83|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||.83|-.23|.27
70966040|NCT02234284|141438435|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.02|TWO_SIDED|95.0|0.07|0.68|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||.68|.07|.02
70966041|NCT02234284|141438436|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.4|TWO_SIDED|95.0|-2.78|1.12|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||1.12|-2.78|.40
70966042|NCT02234284|141438437|SUPERIORITY||Mean Difference (Net)|0.0||||0.98|TWO_SIDED|95.0|-3.0|3.0|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean percent predicted of participants in Health Coached arm minus mean percent predicted in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||3|-3|.98
70966043|NCT02234284|141438438|SUPERIORITY||Mean Difference (Final Values)|-11.5||||0.3|TWO_SIDED|95.0|-33.3|10.2|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||10.2|-33.3|.30
70966044|NCT02234284|141438439|SUPERIORITY||Mean Difference (Final Values)|-0.73||||0.29|TWO_SIDED|95.0|-2.07|0.62|||Mixed Models Analysis||Value is for mean number of days for participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|||0.62|-2.07|.29
70966045|NCT02234284|141438440|SUPERIORITY||Mean Difference (Final Values)|39.7|||<|0.001|TWO_SIDED|95.0|19.6|59.8|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||59.8|19.6|<.001
70966046|NCT02234284|141438441|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.38|TWO_SIDED|95.0|-9.5|25.2|||Mixed Models Analysis||Value is for proportion of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||25.2|-9.5|.38
70966047|NCT02234284|141438442|SUPERIORITY||Median Difference (Final Values)|2.0||||0.73|TWO_SIDED|95.0|-9.4|13.4|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.||Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||13.4|-9.4|.73
70966048|NCT02234284|141438443|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.7|TWO_SIDED|95.0|-14.0|20.8|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||20.8|-14.0|.70
70966049|NCT02234284|141438444|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.97|TWO_SIDED|95.0|-5.5|5.3|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||5.3|-5.5|.97
70966050|NCT02234284|141438445|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.52|TWO_SIDED|95.0|-0.32|1.28|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for rate of outpatient visits for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||1.28|-0.32|.52
70966051|NCT02234284|141438446|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.78|TWO_SIDED|95.0|-0.32|0.22|||Mixed Models Analysis||Value is for rate of COPD-related ED visits for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||0.22|-0.32|.78
70966052|NCT02234284|141438447|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.8|TWO_SIDED|95.0|-0.56|0.4|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for rate of non-COPD-related ED visits for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||0.40|-0.56|.80
70966053|NCT02234284|141438448|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.35|TWO_SIDED|95.0|-0.32|0.06|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for rate of COPD-related hospital visits for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||0.06|-0.32|.35
70966054|NCT02234284|141438449|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.37|TWO_SIDED|95.0|-0.2|0.04|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for rate of non-COPD-related hospitalizations for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||0.04|-0.20|.37
70966055|NCT02234284|141438450|SUPERIORITY||difference in proportion|-18.9||||0.01|TWO_SIDED|95.0|-33.1|-4.8|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||-4.8|-33.1|.01
70966056|NCT02234284|141438451|SUPERIORITY||Mean Difference (Final Values)|14.6||||0.01|TWO_SIDED|95.0|3.3|25.9|||Mixed Models Analysis||Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||25.9|3.3|.01
70966057|NCT01495858|141438453|SUPERIORITY_OR_OTHER|||||||0.3047|||||||ANCOVA|||||||0.3047
70966058|NCT01495858|141438454|SUPERIORITY_OR_OTHER|||||||0.1677|||||||Log Rank|||||||0.1677
70966059|NCT01495858|141438455|SUPERIORITY_OR_OTHER|||||||0.2764|||||||ANCOVA|||||||0.2764
70966060|NCT01495858|141438456|SUPERIORITY_OR_OTHER|||||||0.2764|||||||ANCOVA|||||||0.2764
70966061|NCT01495858|141438457|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70966062|NCT01495858|141438458|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Cochran-Mantel-Haenszel|||||||0.0004
70966063|NCT01495858|141438459|SUPERIORITY_OR_OTHER|||||||0.0145|||||||Cochran-Mantel-Haenszel|||||||0.0145
70966064|NCT01495858|141438460|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Cochran-Mantel-Haenszel|||||||>0.05
70966065|NCT01495858|141438461|SUPERIORITY_OR_OTHER|||||||0.0387|||||||Cochran-Mantel-Haenszel|||||||0.0387
70966066|NCT01495858|141438462|SUPERIORITY_OR_OTHER|||||||0.0305|||||||Cochran-Mantel-Haenszel|||||||0.0305
70966067|NCT01495858|141438463|SUPERIORITY_OR_OTHER|||||||0.0176|||||||Cochran-Mantel-Haenszel|||||||0.0176
70966068|NCT01495858|141438464|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70966069|NCT01495858|141438465|SUPERIORITY_OR_OTHER|||||||0.0036|||||||Cochran-Mantel-Haenszel|||||||0.0036
70966070|NCT01495858|141438466|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
70966071|NCT01495858|141438467|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Cochran-Mantel-Haenszel|||||||>0.05
70966072|NCT01495858|141438468|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Cochran-Mantel-Haenszel|||||||>0.05
70966073|NCT01495858|141438469|SUPERIORITY_OR_OTHER|||||||0.4519|||||||ANCOVA|||||||0.4519
70966074|NCT01495858|141438470|SUPERIORITY_OR_OTHER|||||||0.3707|||||||ANCOVA|||||||0.3707
70966075|NCT01495858|141438471|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Log Rank|||||||>0.05
70966076|NCT01495858|141438473|SUPERIORITY_OR_OTHER|||||||0.3765|||||||Cochran-Mantel-Haenszel|||||||0.3765
70966077|NCT01576172|141438495|SUPERIORITY|||||||0.27|||||||Chi-squared|||||||0.27
70966078|NCT01576172|141438496|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|t=-0.39 on 112.7 degrees of freedom (Satterthwaite)||||||0.70
70966079|NCT01576172|141438497|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.51
70966080|NCT01576172|141438498|SUPERIORITY|||||||0.99|||||||Log Rank|||||||0.99
70966081|NCT01576172|141438499|SUPERIORITY|||||||0.62|||||||Fisher Exact|||||||0.62
70966082|NCT00324753|141438500|SUPERIORITY|||||||0.005||||||p-value based on a test of any treatment difference by site.|Mixed Models Analysis|The model was run using the xtlogit command in Stata and was adjusted for all of the reported baseline characteristics.||||||.005
70966083|NCT01390272|141438552|NON_INFERIORITY_OR_EQUIVALENCE||Mean Difference (Net)|-2.1||||0.26|TWO_SIDED|95.0|-5.9|1.6|||Mixed Models Analysis|Constrained longitudinal model adjusting for baseline stratification variables of diabetes status and blood pressure control.||||1.6|-5.9|0.26
70966084|NCT01390272|141438553|NON_INFERIORITY_OR_EQUIVALENCE||Mean Difference (Net)|-1.3||||0.5|TWO_SIDED|95.0|-4.9|2.4|||Mixed Models Analysis|Constrained longitudinal model adjusting for baseline stratification variables of diabetes status and blood pressure control.||||2.4|-4.9|0.50
70966085|NCT01390272|141438554|NON_INFERIORITY_OR_EQUIVALENCE||Mean Difference (Net)|-1.6||||0.43|TWO_SIDED|95.0|-5.6|2.4|||Mixed Models Analysis|Constrained longitudinal model adjusting for baseline stratification variables of diabetes status and blood pressure control.||||2.4|-5.6|0.43
70966086|NCT01390272|141438556|NON_INFERIORITY_OR_EQUIVALENCE||Odds Ratio (OR)|1.0||||0.83|TWO_SIDED|95.0|0.7|1.6|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link. Adjusted for baseline stratification variables of diabetes status.||Comparison at 6 months||1.6|0.7|0.83
70966087|NCT01390272|141438557|NON_INFERIORITY_OR_EQUIVALENCE||Odds Ratio (OR)|0.9||||0.53|TWO_SIDED|95.0|0.5|1.4|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link. Adjusted for baseline stratification variables of diabetes status.||Comparison at 12 months||1.4|0.5|0.53
70966088|NCT01390272|141438558|NON_INFERIORITY_OR_EQUIVALENCE||Odds Ratio (OR)|1.5||||0.09|TWO_SIDED|95.0|0.9|2.3|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link. Adjusted for baseline stratification variables of diabetes status.||Comparison at 18 months.||2.3|0.9|0.09
70966089|NCT01390272|141438561|NON_INFERIORITY_OR_EQUIVALENCE||Odds Ratio (OR)|1.0||||0.95|TWO_SIDED|95.0|0.7|1.5|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link. Adjusted for baseline stratification variable of diabetes status and diabetes control.||||1.5|0.7|0.95
70966090|NCT01390272|141438562|NON_INFERIORITY_OR_EQUIVALENCE||Odds Ratio (OR)|1.4||||0.12|TWO_SIDED|95.0|0.9|2.1|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link.Adjusted for baseline stratification variable of diabetes status and blood pressure control.||Comparison at 12 months||2.1|0.9|0.12
70966091|NCT01390272|141438563|NON_INFERIORITY_OR_EQUIVALENCE||Odds Ratio (OR)|1.2||||0.3|TWO_SIDED|95.0|0.8|1.9|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link. Adjusted for baseline stratification variables of diabetes status and blood pressure control.||Comparison at 18 months||1.9|0.8|0.30
70966092|NCT02887404|141438566|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.92|TWO_SIDED|95.0|-6.0|6.0|||t-test, 2 sided|||||6|-6|0.92
70966093|NCT02887404|141438567|NON_INFERIORITY|Delta: 15. The significance level for non-inferiority was 0.025|Median Difference (Final Values)|-9.0|||<|0.001|TWO_SIDED|95.0|-21.0|3.0|||Hodges-Lehmann estimator|||||3|-21|<0.001
70966094|NCT02887404|141438567|SUPERIORITY||Median Difference (Final Values)|-9.0||||0.175|TWO_SIDED|97.5|-23.0|5.0||We adjusted for two outcomes for the superiority testing only, using a significance criterion of 0.0125 for each outcome (i.e., 0.025/2, Bonferroni correction), since superiority on either outcome would suffice.|Hodges-Lehmann estimator|||||5|-23|0.175
70966095|NCT02887404|141438568|NON_INFERIORITY|Delta: 1 The significance level for the non-inferiority test was 0.025.|Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.8|1.0||This is a joint hypothesis testing. We tested non-inferiority on both secondary outcomes. If both showed significant non-inferiority, we tested superiority on both outcomes.|Regression, Linear|||||1|-0.8|<0.001
70966096|NCT02887404|141438568|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.094|TWO_SIDED|97.5|-0.8|0.1||We adjusted for two outcomes for the superiority testing only, using a significance criterion of 0.0125 for each outcome (i.e., 0.025/2, Bonferroni correction), since superiority on either outcome would suffice|Regression, Linear|||||0.1|-0.8|0.094
70966097|NCT02887404|141438586|NON_INFERIORITY|Delta: 9; significance level was 0.025|Median Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.3|0.1|||Wilcoxon (Mann-Whitney)|||||0.1|-0.3|<0.001
70966098|NCT02887404|141438586|SUPERIORITY||Median Difference (Final Values)|-0.1||||0.171|TWO_SIDED|97.5|-0.3|0.1||We adjusted for two outcomes for the superiority testing only, using a significance criterion of 0.0125 for each outcome (i.e., 0.025/2, Bonferroni correction), since superiority on either outcome would suffice|Wilcoxon sum rank test|||||0.1|-0.3|0.171
70966099|NCT02887404|141438587|NON_INFERIORITY|Delta: 1 significance level: 0.025|Mean Difference (Final Values)|-0.5|||<|0.001|TWO_SIDED|95.0|-1.0|-0.1|||Regression, Linear||||The superiority test (this is a joint-hypothesis testing) showed a mean difference of -0.5 between treatment and control group with 97.5% CI of (-1.0, 0.0) and p-value of 0.025. The significance level was 0.025.|-0.1|-1.0|<0.001
70966100|NCT02887404|141438587|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.025|TWO_SIDED|97.5|-1.0|0.0||We adjusted for two outcomes for the superiority testing only, using a significance criterion of 0.0125 for each outcome (i.e., 0.025/2, Bonferroni correction), since superiority on either outcome would suffice|Regression, Linear|||||0.0|-1.0|0.025
70966101|NCT01536951|141438588|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|0.239|||||TWO_SIDED|90.0|-1.65|2.12|||||LS mean difference (LY3009104 minus placebo) of change in QTcP 1 h postdose analyzed using analysis of covariance (ANCOVA) model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||2.12|-1.65|
70966102|NCT01536951|141438588|SUPERIORITY_OR_OTHER||LS mean difference|1.81|||||TWO_SIDED|90.0|-0.079|3.69|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 1.5 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||3.69|-0.0790|
70966103|NCT01536951|141438588|SUPERIORITY_OR_OTHER||LS Mean Difference|1.44|||||TWO_SIDED|90.0|-0.446|3.32|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 2 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||3.32|-0.446|
70966104|NCT01536951|141438588|SUPERIORITY_OR_OTHER||LS mean difference|0.468|||||TWO_SIDED|90.0|-1.42|2.35|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 3 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||2.35|-1.42|
70966105|NCT01536951|141438588|SUPERIORITY_OR_OTHER||LS mean difference|0.702|||||TWO_SIDED|90.0|-1.18|2.59|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 4 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||2.59|-1.18|
70966106|NCT01536951|141438588|SUPERIORITY_OR_OTHER||LS mean difference|-0.788|||||TWO_SIDED|90.0|-2.68|1.1|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 6 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||1.10|-2.68|
70966107|NCT01536951|141438588|SUPERIORITY_OR_OTHER||LS mean difference|1.71|||||TWO_SIDED|90.0|-0.182|3.6|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 12 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||3.60|-0.182|
70966108|NCT01536951|141438588|SUPERIORITY_OR_OTHER||LS mean difference|0.963|||||TWO_SIDED|90.0|-0.921|2.85|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 24 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||2.85|-0.921|
70966109|NCT01536951|141438588|SUPERIORITY_OR_OTHER||LS mean difference|12.3|||||TWO_SIDED|90.0|10.0|14.5|||||LS mean difference (moxifloxacin minus placebo) of change in QTcP at 1 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||14.5|10.0|
70966110|NCT01536951|141438588|SUPERIORITY_OR_OTHER||LS mean difference|11.0|||||TWO_SIDED|90.0|8.74|13.3|||||LS mean difference (moxifloxacin minus placebo) of change in QTcP at 2 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||13.3|8.74|
70966111|NCT01536951|141438588|SUPERIORITY_OR_OTHER||LS mean difference|11.1|||||TWO_SIDED|90.0|8.87|13.4|||||LS mean difference (moxifloxacin minus placebo) of change in QTcP at 4 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||13.4|8.87|
70966112|NCT00545402|141438595|SUPERIORITY_OR_OTHER|||||||0.2611|||||||Log Rank|||||||0.2611
70966113|NCT00545402|141438597|SUPERIORITY_OR_OTHER|||||||0.7091|||||||Log Rank|||||||0.7091
70966114|NCT01721876|141438601|SUPERIORITY|The 2-sided test of the hypothesis was performed at a 0.05 level of significance. An odds ratio (OR) = 1 would indicate that the odds of achieving CR+CRi with Volasertib + Low-dose Cytarabine is equal to the odds of achieving CR+CRi with Placebo + Low-dose Cytarabine , whereas an OR ≠ 1 would indicate the opposite. H0, CR+CRi: OR = 1 vs. Ha, CR+CRi: OR ≠ 1.|Odds Ratio (OR)|1.8751||||0.0024|TWO_SIDED|95.0|1.2432|2.8281|||Cochran-Mantel-Haenszel||Common odds ratio is calculated by Mantel-Haenszel estimate adjusting for the two stratification factors (baseline Eastern Cooperative Oncology Group (ECOG) and type of AML). If odds ratio is above 1 then it favours Volasertib+Low-dose Cytarabine.|This analysis was exploratory and descriptive.||2.8281|1.2432|0.0024
70966115|NCT01721876|141438602|SUPERIORITY|The hazard ratio (HR) between Volasertib + Low-dose Cytarabine and Placebo + Low-dose Cytarabine was tested against 1. The null hypothesis, H0,OS, was that the hazards are equal between Volasertib + Low-dose Cytarabine and Placebo + Low-dose Cytarabine, whereas the alternative hypothesis, Ha,OS, was that the hazards are not equal between the 2 treatment arms. H0, OS: HR = 1 vs. Ha, OS: HR ≠ 1.|Hazard Ratio (HR)|0.97||||0.7571|TWO_SIDED|95.0|0.8|1.2||P-value is calculated from log-rank test stratified by baseline ECOG (0-1 vs. 2) and type of AML (denovo vs. secondary).|Regression, Cox||Hazard ratio is calculated from Cox proportional hazard model stratified by baseline ECOG and type of AML. If hazard ratio is below 1 then it favours volasertib.|This analysis was exploratory and descriptive.||1.2|0.8|0.7571
70966116|NCT01721876|141438603|SUPERIORITY|The hazard ratio (HR) between Volasertib + Low-dose Cytarabine and Placebo + Low-dose Cytarabine was tested against 1. The null hypothesis, H0,OS, was that the hazards are equal between Volasertib + Low-dose Cytarabine and Placebo + Low-dose Cytarabine, whereas the alternative hypothesis, Ha,OS, was that the hazards are not equal between the 2 treatment arms. H0, OS: HR = 1 vs. Ha, OS: HR ≠ 1.|Hazard Ratio (HR)|0.96||||0.6718|TWO_SIDED|95.0|0.8|1.2||P-value is calculated from log-rank test stratified by baseline ECOG (0-1 vs. 2) and type of AML (denovo vs. secondary).|Regression, Cox||Hazard ratio is calculated from Cox proportional hazard model stratified by baseline ECOG and type of AML. If hazard ratio is below 1 then it favours volasertib.|This analysis was exploratory and descriptive.||1.2|0.8|0.6718
70966117|NCT01721876|141438604|OTHER||Hazard Ratio (HR)|1.37|||||TWO_SIDED|95.0|0.7|2.7|||Regression, Cox||Hazard ratio is calculated from Cox proportional hazard model stratified by baseline ECOG and type of AML. If hazard ratio is below 1 then it favours volasertib.|||2.7|0.7|
70966118|NCT01721057|141438605|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||Regression, Logistic|||||||0.001
70966119|NCT03805750|141438631|OTHER|||||||0.52|||||||Regression, Logistic|||||||0.52
70966120|NCT00789880|141438640|SUPERIORITY_OR_OTHER|||||||0.7|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether the change in CAMP expression in lesional skin of AD participants differs by treatment group.||||0.7
70966121|NCT00789880|141438640|SUPERIORITY_OR_OTHER|||||||0.12|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether the change in CAMP mRNA expression in non-lesional skin of AD participants differs by treatment group.||||0.12
70966122|NCT00789880|141438641|SUPERIORITY_OR_OTHER|||||||0.3|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether the change in CAMP mRNA expression in non-lesional skin of Non-AD participants differs by treatment group.||||0.3
70966123|NCT00789880|141438642|SUPERIORITY_OR_OTHER|||||||0.4|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether change in CAMP mRNA expression in lesional skin of psoriatic participants differs by treatment group.||||0.4
70966124|NCT00789880|141438642|SUPERIORITY_OR_OTHER|||||||0.2|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether change in CAMP mRNA expression in non-lesional skin of psoriatic participants differs by treatment group.||||0.2
70966125|NCT00789880|141438643|SUPERIORITY_OR_OTHER|||||||0.8|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether change in HBD-3 mRNA expression in lesional skin of AD participants differs by treatment group.||||0.8
70966126|NCT00789880|141438643|SUPERIORITY_OR_OTHER|||||||0.2|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether change in HBD-3 mRNA expression in non-lesional skin of AD participants differs by treatment group.||||0.2
70966127|NCT00789880|141438644|SUPERIORITY_OR_OTHER|||||||0.4||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in HBD-3 mRNA expression in non-lesional skin of Non-AD participants differs by treatment group.||||0.4
70966128|NCT00789880|141438645|SUPERIORITY_OR_OTHER|||||||0.4||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in HBD-3 mRNA expression in lesional skin of psoriatic participants differs by treatment group.||||0.4
70966129|NCT00789880|141438645|SUPERIORITY_OR_OTHER|||||||1||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in HBD-3 mRNA expression in non-lesional skin of psoriatic participants differs by treatment group.||||1.0
70966130|NCT00789880|141438646|SUPERIORITY_OR_OTHER|||||||0.2||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in IL-13 mRNA expression in lesional skin of AD participants differs by treatment group.||||0.2
70966131|NCT00789880|141438646|SUPERIORITY_OR_OTHER|||||||0.5||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in IL-13 mRNA expression in non-lesional skin of AD participants differs by treatment group.||||0.5
70966132|NCT00789880|141438647|SUPERIORITY_OR_OTHER|||||||0.7||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in IL-13 mRNA expression in non-lesional skin of Non-AD participants differs by treatment group.||||0.7
70966133|NCT00789880|141438648|SUPERIORITY_OR_OTHER|||||||0.2||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in IL-13 mRNA expression in lesional skin of psoriatic participants differs by treatment group.||||0.2
70966134|NCT00789880|141438648|SUPERIORITY_OR_OTHER|||||||0.3||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in IL-13 mRNA expression in non-lesional skin of psoriatic participants differs by treatment group.||||0.3
70966135|NCT02568475|141438659|EQUIVALENCE|Continuous scale: score compares results before and after intervention without a cut parameter.|Mean Difference (Final Values)|3.59|STANDARD_ERROR_OF_MEAN|1.74||0.046|TWO_SIDED|95.0|0.059|7.12|||t-test, 2 sided|||||7.12|0.059|0.046
70966136|NCT02568475|141438660|OTHER|This is a continuous scale with no clinical cut score/value. We tested mean differences between the two groups.|Mean Difference (Final Values)|6.78||||0.001|TWO_SIDED|95.0|2.9|10.6|||t-test, 2 sided|||||10.6|2.9|0.001
70966137|NCT02426476|141438664|SUPERIORITY||||||<|0.01||||||Group by Time interaction|Mixed Models Analysis|||Linear mixed models for repeated measures (PROC MIXED in SAS) were used to assess the effects of intervention group, time, and the group by time interaction. A directional (one-sided) hypothesis was tested for the Group-by-Time interaction. The covariance matrix that minimized the Akaike Information Criterion was used. Each outcome was evaluated separately. Models were adjusted for baseline depression score and race.||||<0.01
70966138|NCT02426476|141438665|SUPERIORITY|||||||0.87||||||Group by Time interaction|Mixed Models Analysis|||||||0.87
70966139|NCT02426476|141438666|SUPERIORITY||||||<|0.01||||||Group by Time Interaction|Mixed Models Analysis|||Linear mixed models for repeated measures (PROC MIXED in SAS) were used to assess the effects of intervention group, time, and the group by time interaction. A directional (one-sided) hypothesis was tested for the Group-by-Time interaction. The covariance matrix that minimized the Akaike Information Criterion was used. Each outcome was evaluated separately. Models were adjusted for baseline depression score and race.||||<0.01
70966140|NCT04136184|141438684|SUPERIORITY||Difference in LS Mean|-24.7593||||1e-08|TWO_SIDED|95.0|-30.9552|-18.5635|||MMRM|||||-18.5635|-30.9552|0.00000001
70966141|NCT04136184|141438685|SUPERIORITY||Difference in LS Mean|-19.7352||||1e-08|TWO_SIDED|95.0|-25.6301|-13.8403|||MMRM|||||-13.8403|-25.6301|0.00000001
70966142|NCT04136184|141438686|SUPERIORITY||Difference in LS Mean|-70.42||||1e-08|TWO_SIDED|95.0|-75.17|-65.66|||MMRM|||||-65.66|-75.17|0.00000001
70966143|NCT04136184|141438687|SUPERIORITY||Difference in LS Mean|-66.65||||1e-08|TWO_SIDED|95.0|-71.59|-61.71|||MMRM|||||-61.71|-71.59|0.00000001
70966144|NCT04136184|141438688|SUPERIORITY||Difference in LS Mean|-9.3542||||0.00012203|TWO_SIDED|95.0|-13.8691|-4.8394|||MMRM|||||-4.8394|-13.8691|0.00012203
70966145|NCT04136184|141438689|SUPERIORITY||Difference in LS Mean|-11.8202||||1.873e-05|TWO_SIDED|95.0|-16.8927|-6.7477|||MMRM|||||-6.7477|-16.8927|0.00001873
70966146|NCT04136184|141438690|SUPERIORITY||Difference in LS Mean|-3.94||||0.00052447|TWO_SIDED|95.0|-6.08|-1.8|||MMRM|||Week 35||-1.80|-6.08|0.00052447
70966147|NCT04136184|141438690|SUPERIORITY||Difference in LS Mean|-8.21||||1e-08|TWO_SIDED|95.0|-10.65|-5.76|||MMRM|||Week 66||-5.76|-10.65|0.00000001
70966148|NCT04136184|141438691|SUPERIORITY||Difference in LS Mean|5.305||||5.58e-06|TWO_SIDED|95.0|3.195|7.416|||MMRM|||||7.416|3.195|0.00000558
70966149|NCT04136184|141438692|SUPERIORITY||Difference in LS Mean|-0.2||||0.02407897|TWO_SIDED|95.0|-0.4|0.0|||MMRM|||||-0.0|-0.4|0.02407897
70966150|NCT04136184|141438693|SUPERIORITY||Difference in LS Mean|82.6991||||2e-07|TWO_SIDED|95.0|54.6431|110.7551|||MMRM|||||110.7551|54.6431|0.00000020
70966151|NCT03734016|141438724|NON_INFERIORITY|Non-inferiority testing for ORR was performed using a stratified Wald test based on the stratified Mantel-Haenszel response ratio estimate against the non-inferiority margin of 0.8558 on the log scale.|Response ratio|1.12|||<|0.0001|TWO_SIDED|95.0|1.04|1.22|||Stratified Wald test|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)|Response ratio is the estimated ratio of the overall response rate of the zanubrutinib arm divided by that of the ibrutinib arm.|||1.22|1.04|<0.0001
70966152|NCT03734016|141438724|SUPERIORITY|||||||0.0035||||||Superiority testing was performed using a 2-sided stratified Cochran-Mantel-Haenszel test.|Cochran-Mantel-Haenszel|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)||||||0.0035
70966153|NCT03734016|141438725|NON_INFERIORITY|Non-inferiority testing for ORR was performed using a stratified Wald test based on the stratified Mantel-Haenszel response ratio estimate against the non-inferiority margin of 0.8558 on the log scale.|Response ratio|1.14|||<|0.0001|TWO_SIDED|95.0|1.05|1.22|||Stratified Wald test|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)|Response ratio is the estimated ratio of the overall response rate of the zanubrutinib arm divided by that of the ibrutinib arm.|||1.22|1.05|<0.0001
70966154|NCT03734016|141438725|SUPERIORITY|Superiority testing was performed using a 2-sided stratified Cochran-Mantel-Haenszel test.||||||0.0007|||||||Cochran-Mantel-Haenszel|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)||||||0.0007
70966155|NCT03734016|141438726|NON_INFERIORITY|Non-inferiority was tested with a non-inferiority margin (hazard ratio) of 1.33 with the use of a stratified Wald test based on the four randomization stratification factors.|Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.49|0.86|||Stratified Wald test|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)|Hazard ratio is the ratio of the hazard of the zanubrutinib arm divided by that of the ibrutinib arm.|||0.86|0.49|<0.0001
70966156|NCT03734016|141438726|SUPERIORITY|||||||0.0024|||||||Stratified Log-rank test|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)||||||0.0024
70966157|NCT03734016|141438727|NON_INFERIORITY|Noninferiority was tested with a noninferiority margin (hazard ratio) of 1.33 with the use of a stratified Wald test based on the four randomization stratification factors.|Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.49|0.86||Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)|Stratified Wald test||Hazard ratio is the ratio of the hazard of the zanubrutinib arm divided by that of the ibrutinib arm.|||0.86|0.49|<0.0001
70966158|NCT03734016|141438727|SUPERIORITY|||||||0.0024|||||||Stratified Log-rank test|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)||||||0.0024
70966159|NCT03734016|141438728|SUPERIORITY||Rate Difference|-8.0||||0.0004|TWO_SIDED|95.0|-12.4|-3.6|||Chi-squared||Rate difference is the zanubrutinib rate minus the ibrutinib rate.|||-3.6|-12.4|0.0004
70966160|NCT03734016|141438731|OTHER||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.41|0.72|||||Hazard ratio is the ratio of the hazard of the zanubrutinib arm divided by that of the ibrutinib arm.|||0.72|0.41|
70966161|NCT03734016|141438734|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.51|1.11|||||Hazard ratio is the ratio of the hazard of the zanubrutinib arm divided by that of the ibrutinib arm.|||1.11|0.51|
70966162|NCT03734016|141438735|OTHER||Least Squares (LS) Mean Difference|3.0||||0.0338|TWO_SIDED|95.0|0.23|5.77|||Mixed model for repeated measures (MMRM)|||Analysis of Change from Baseline in EORTC QLQ-C30 GHS/QOL at Week 24. A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix.||5.77|0.23|0.0338
70966163|NCT03734016|141438735|OTHER||LS Mean Difference|1.34||||0.3304|TWO_SIDED|95.0|-1.37|4.06|||Mixed model for repeated measures (MMRM)|||Analysis of Change from Baseline in EORTC QLQ-C30 GHS/QOL at Week 48. A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix.||4.06|-1.37|0.3304
70966164|NCT03734016|141438735|OTHER||LS Mean Difference|1.82||||0.1189|TWO_SIDED|95.0|-0.47|4.12|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Physical Functioning Scale at Week 24.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||4.12|-0.47|0.1189
70966165|NCT03734016|141438735|OTHER||LS Mean Difference|1.15||||0.3274|TWO_SIDED|95.0|-1.15|3.44|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Physical Functioning Scale at Week 48.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||3.44|-1.15|0.3274
70966166|NCT03734016|141438735|OTHER||LS Mean Difference|0.63||||0.6821|TWO_SIDED|95.0|-2.4|3.66|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Role Functioning Scale at Week 24.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||3.66|-2.40|0.6821
70966167|NCT03734016|141438735|OTHER||LS Mean Difference|1.8||||0.2701|TWO_SIDED|95.0|-1.4|5.0|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Role Functioning Scale at Week 48.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||5.00|-1.40|0.2701
70966168|NCT03734016|141438736|OTHER||LS Mean Difference|-1.91||||0.1778|TWO_SIDED|95.0|-4.7|0.87|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Fatigue Symptom Scale at Week 24.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||0.87|-4.70|0.1778
70966169|NCT03734016|141438736|OTHER||LS Mean Difference|-0.35||||0.8174|TWO_SIDED|95.0|-3.32|2.62|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Fatigue Symptom Scale at Week 48.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||2.62|-3.32|0.8174
70966170|NCT03734016|141438736|OTHER||LS Mean Difference|-0.29||||0.6294|TWO_SIDED|95.0|-1.48|0.89|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Nausea and Vomiting Symptom Scale at Week 24.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||0.89|-1.48|0.6294
70966171|NCT03734016|141438736|OTHER||LS Mean Difference|-0.51||||0.4933|TWO_SIDED|95.0|-1.99|0.96|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Nausea and Vomiting Symptom Scale at Week 48.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||0.96|-1.99|0.4933
70966172|NCT03734016|141438736|OTHER||LS Mean Difference|-1.43||||0.3643|TWO_SIDED|95.0|-4.51|1.66|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Pain Symptom Scale at Week 24.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||1.66|-4.51|0.3643
70966173|NCT03734016|141438736|OTHER||LS Mean Difference|-2.43||||0.1363|TWO_SIDED|95.0|-5.62|0.77|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Pain Symptom Scale at Week 48.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||0.77|-5.62|0.1363
70966174|NCT03734016|141438736|OTHER||LS Mean Difference|-1.59||||0.2001|TWO_SIDED|95.0|-4.01|0.84|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Diarrhoea Symptom Scale at Week 24.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||0.84|-4.01|0.2001
70966175|NCT03734016|141438736|OTHER||LS Mean Difference|-1.85||||0.1121|TWO_SIDED|95.0|-4.12|0.43|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Diarrhoea Symptom Scale at Week 48.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||0.43|-4.12|0.1121
70966176|NCT00418665|141438773|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||||95.0|0.07|5.136|||||Romiplostim/placebo|||5.136|0.070|
70966177|NCT00418665|141438773|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.154||||||95.0|0.022|1.071|||||Romiplostim/placebo|||1.071|0.022|
70966178|NCT00418665|141438774|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.154||||||95.0|0.022|1.071|||||Romiplostim/placebo|||1.071|0.022|
70966179|NCT00418665|141438774|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.514||||||95.0|0.102|2.589|||||Romiplostim/placebo|||2.589|0.102|
70966180|NCT00418665|141438775|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.0||||||95.0|0.227|39.608|||||Romiplostim/placebo|||39.608|0.227|
70966181|NCT00418665|141438775|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.714||||||95.0|0.144|20.473|||||Romiplostim/placebo|||20.473|0.144|
70966182|NCT00418665|141438776|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.911||||||95.0|0.097|8.529|||||Romiplostim/placebo|||8.529|0.097|
70966183|NCT00418665|141438776|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.866||||||95.0|0.175|4.278|||||Romiplostim/placebo|||4.278|0.175|
70966184|NCT01133379|141438780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|4.75||0.811|TWO_SIDED|95.0|-10.5|8.24||Per statistical analysis plan, if experimental rinse (12027-019) was better than vehicle control at Week 6 (p\<0.05), testing for 12027-019 versus vehicle control proceeded to Week 4. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||8.24|-10.5|0.811
70966185|NCT01133379|141438780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.75|STANDARD_ERROR_OF_MEAN|4.75||0.105|TWO_SIDED|95.0|-17.1|1.63||Per statistical analysis plan, if experimental rinse (12027-020) was better than vehicle control at Week 6 (p\<0.05), testing for 12027-020 versus vehicle control proceeded to Week 4. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.63|-17.1|0.105
70966186|NCT01133379|141438781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|3.969||0.779|TWO_SIDED|95.0|-6.72|8.95||Per statistical analysis plan, if experimental rinse (12027-019) was better than vehicle control at Week 4 (p\<0.05), testing for 12027-019 versus vehicle control proceeded to Week 2. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||8.95|-6.72|0.779
70966187|NCT01133379|141438781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.92|STANDARD_ERROR_OF_MEAN|3.969||0.217|TWO_SIDED|95.0|-12.8|2.92||Per statistical analysis plan, if experimental rinse (12027-020) was better than vehicle control at Week 4 (p\<0.05), testing for 12027-020 versus vehicle control proceeded to Week 2. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.92|-12.8|0.217
70966188|NCT01133379|141438782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|2.613||0.904|TWO_SIDED|95.0|-4.84|5.47||Per statistical analysis plan, if experimental rinse (12027-019) was better than vehicle control at Week 2 (p\<0.05), testing for 12027-019 versus vehicle control proceeded to Week 1. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||5.47|-4.84|0.904
70966189|NCT01133379|141438782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.99|STANDARD_ERROR_OF_MEAN|2.613||0.129|TWO_SIDED|95.0|-9.15|1.17||Per statistical analysis plan, if experimental rinse (12027-020) was better than vehicle control at Week 2 (p\<0.05), testing for 12027-020 versus vehicle control proceeded to Week 1. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.17|-9.15|0.129
70966190|NCT01133379|141438783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|1.336||0.477|TWO_SIDED|95.0|-3.59|1.69||The significance threshold was 0.05. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.69|-3.59|0.477
70966191|NCT01133379|141438783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|1.336||0.472|TWO_SIDED|95.0|-3.6|1.67||The significance threshold was 0.05. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.67|-3.60|0.472
70966192|NCT01133379|141438784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|2.726||0.86|TWO_SIDED|95.0|-5.86|4.9||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||4.90|-5.86|0.860
70966193|NCT01133379|141438784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|2.723||0.763|TWO_SIDED|95.0|-6.2|4.55||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||4.55|-6.20|0.763
70966194|NCT01133379|141438785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|2.856||0.488|TWO_SIDED|95.0|-7.62|3.66||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||3.66|-7.62|0.488
70966195|NCT01133379|141438785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|2.854||0.311|TWO_SIDED|95.0|-8.54|2.73||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups||2.73|-8.54|0.311
70966196|NCT01133379|141438786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|3.478||0.604|TWO_SIDED|95.0|-8.68|5.06||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||5.06|-8.68|0.604
70966197|NCT01133379|141438786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.91|STANDARD_ERROR_OF_MEAN|3.477||0.583|TWO_SIDED|95.0|-4.95|8.78||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||8.78|-4.95|0.583
70966198|NCT01133379|141438787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|3.61||0.847|TWO_SIDED|95.0|-7.83|6.43||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||6.43|-7.83|0.847
70966199|NCT01133379|141438787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|3.61||0.708|TWO_SIDED|95.0|-5.77|8.48||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||8.48|-5.77|0.708
70966200|NCT01133379|141438788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.46|STANDARD_ERROR_OF_MEAN|2.678||0.36|TWO_SIDED|95.0|-7.75|2.83||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.83|-7.75|0.360
70966201|NCT01133379|141438788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.88|STANDARD_ERROR_OF_MEAN|2.679||0.149|TWO_SIDED|95.0|-9.17|1.41||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.41|-9.17|0.149
70966202|NCT01133379|141438789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.61|STANDARD_ERROR_OF_MEAN|3.235||0.421|TWO_SIDED|95.0|-9.0|3.78||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||3.78|-9.00|0.421
70966203|NCT01133379|141438789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.66|STANDARD_ERROR_OF_MEAN|3.235||0.26|TWO_SIDED|95.0|-10.0|2.73||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.73|-10.0|0.260
70966204|NCT01133379|141438790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|3.601||0.989|TWO_SIDED|95.0|-7.16|7.06||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||7.06|-7.16|0.989
70966205|NCT01133379|141438790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|3.599||0.721|TWO_SIDED|95.0|-8.39|5.82||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||5.82|-8.39|0.721
70966206|NCT01133379|141438791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21|STANDARD_ERROR_OF_MEAN|3.69||0.743|TWO_SIDED|95.0|-8.5|6.07||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||6.07|-8.50|0.743
70966207|NCT01133379|141438791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|3.688||0.928|TWO_SIDED|95.0|-7.61|6.95||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||6.95|-7.61|0.928
70966208|NCT01133379|141438792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|2.369||0.683|TWO_SIDED|95.0|-3.71|5.65||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||5.65|-3.71|0.683
70966209|NCT01133379|141438792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|2.371||0.914|TWO_SIDED|95.0|-4.94|4.42||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||4.42|-4.94|0.914
70966210|NCT01133379|141438793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.19|STANDARD_ERROR_OF_MEAN|2.994||0.04|TWO_SIDED|95.0|-12.1|-0.27||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.27|-12.1|0.040
70966211|NCT01133379|141438793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|2.997||0.043|TWO_SIDED|95.0|-12.0|-0.18||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.18|-12.0|0.043
70966212|NCT01133379|141438794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.32|STANDARD_ERROR_OF_MEAN|3.522||0.511|TWO_SIDED|95.0|-9.27|4.64||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||4.64|-9.27|0.511
70966213|NCT01133379|141438794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.07|STANDARD_ERROR_OF_MEAN|3.526||0.25|TWO_SIDED|95.0|-11.0|2.89||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.89|-11.0|0.250
70966214|NCT01133379|141438795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.41|STANDARD_ERROR_OF_MEAN|3.684||0.233|TWO_SIDED|95.0|-11.7|2.86||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.86|-11.7|0.233
70966215|NCT01133379|141438795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.84|STANDARD_ERROR_OF_MEAN|3.687||0.115|TWO_SIDED|95.0|-13.1|1.44||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.44|-13.1|0.115
70966216|NCT00841204|141438805|OTHER|||||||0.0056|||||||Wilcoxon (Mann-Whitney)|||||||0.0056
70966217|NCT00841204|141438806|OTHER|||||||0.386|||||||Wilcoxon (Mann-Whitney)|||||||0.386
70966218|NCT00841204|141438807|OTHER||||||<|0.05|||||||Regression, Linear|||||||<0.05
70966219|NCT00841204|141438808|OTHER|||||||0.58|||||||Regression, Linear|||||||0.58
70966220|NCT00841204|141438809|OTHER|||||||0.12|||||||Regression, Linear|||||||0.12
70966221|NCT05470465|141438812|SUPERIORITY||Mean Difference (Final Values)|-6.5|||<|0.001|ONE_SIDED|97.5||-3.1||To demonstrate an effect of oxycodone with paroxetine compared to oxycodone alone, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-3.1||<0.001
70966222|NCT05470465|141438812|SUPERIORITY||Mean Difference (Final Values)|-5.5||||0.001|ONE_SIDED|97.5||-2.1||To demonstrate an effect of oxycodone with escitalopram compared to oxycodone alone, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and escitalopram compared to oxycodone and placebo.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-2.1||0.001
70966223|NCT05470465|141438813|SUPERIORITY||Mean Difference (Final Values)|-6.5||||0.002|ONE_SIDED|97.5||-2.1||To demonstrate an effect of paroxetine compared to placebo, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of paroxetine compared to placebo.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-2.1||0.002
70966224|NCT05470465|141438813|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.003|ONE_SIDED|97.5||-2.5||To demonstrate an effect of escitalopram compared to placebo, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of escitalopram compared to placebo.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-2.5||0.003
70966225|NCT05470465|141438814|SUPERIORITY||Mean Difference (Final Values)|-7.1|||<|0.001|ONE_SIDED|97.5||-4.1||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of oxycodone and paroxetine compared to oxycodone, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo at day 6 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-4.1||<0.001
70966226|NCT05470465|141438814|SUPERIORITY||Mean Difference (Final Values)|-5.6|||<|0.001|ONE_SIDED|97.5||-2.6||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of oxycodone and escitalopram compared to oxycodone, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and escitalopram compared to oxycodone and placebo at day 6 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-2.6||<0.001
70966227|NCT05470465|141438815|SUPERIORITY||Mean Difference (Final Values)|-10.1|||<|0.001|ONE_SIDED|97.5||-5.9||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of oxycodone and paroxetine compared to oxycodone, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo at day 12 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-5.9||<0.001
70966228|NCT05470465|141438815|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.003|ONE_SIDED|97.5||-2.7||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of oxycodone and escitalopram compared to oxycodone, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo at day 12 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-2.7||0.003
70966229|NCT05470465|141438816|SUPERIORITY||Mean Difference (Final Values)|-11.6|||<|0.001|ONE_SIDED|97.5||-6.5||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of paroxetine compared to placebo, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of paroxetine compared to placebo at day 5 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-6.5||<0.001
70966230|NCT05470465|141438816|SUPERIORITY||Mean Difference (Final Values)|-14.0|||<|0.001|ONE_SIDED|97.5||-9.0||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of escitalopram compared to placebo, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of escitalopram compared to placebo at day 5 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-9.0||<0.001
70966231|NCT05470465|141438817|SUPERIORITY||Mean Difference (Final Values)|-14.1|||<|0.001|ONE_SIDED|97.5||-8.5||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of paroxetine compared to placebo, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of paroxetine compared to placebo at day 11 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-8.5||<0.001
70966232|NCT05470465|141438817|SUPERIORITY||Mean Difference (Final Values)|-9.5|||<|0.001|ONE_SIDED|97.5||-3.8||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of escitalopram compared to placebo, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of escitalopram compared to placebo at day 11 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-3.8||<0.001
70966233|NCT01704287|141438818|SUPERIORITY_OR_OTHER_LEGACY|Cox regression model with treatment as covariate stratified by Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1); lactate dehydrogenase (LDH) levels (normal vs. elevated LDH levels \[≥110% Upper Limit of Normal (ULN)\]); \& BRAF mutational status (mutant vs. wild-type)|Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.46|0.73||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=ICC|||0.73|0.46|<0.0001
70966234|NCT01704287|141438818|SUPERIORITY_OR_OTHER_LEGACY|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)|Hazard Ratio (HR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.37|0.6||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=ICC|||0.60|0.37|<0.0001
70966235|NCT01704287|141438818|SUPERIORITY_OR_OTHER_LEGACY|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)|Hazard Ratio (HR)|0.83||||0.1247|TWO_SIDED|95.0|0.66|1.05||Two-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg|||1.05|0.66|0.1247
70966236|NCT01704287|141438819|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.1173|TWO_SIDED|95.0|0.67|1.1||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.10|0.67|0.1173
70966237|NCT01704287|141438819|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.0106|TWO_SIDED|95.0|0.57|0.96||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||0.96|0.57|0.0106
70966238|NCT01704287|141438819|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.2905|TWO_SIDED|95.0|0.67|1.12||Two-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.12|0.67|0.2905
70966239|NCT01704287|141438820|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.1146|TWO_SIDED|95.0|0.68|1.1||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.10|0.68|0.1146
70966240|NCT01704287|141438820|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.0023|TWO_SIDED|95.0|0.55|0.9||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||0.90|0.55|0.0023
70966241|NCT01704287|141438820|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.149|TWO_SIDED|95.0|0.66|1.07||Two-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.07|0.66|0.1490
70966242|NCT01704287|141438821|SUPERIORITY_OR_OTHER_LEGACY|PD-L1-Positive Participants|Hazard Ratio (HR)|0.92||||0.3113|TWO_SIDED|95.0|0.66|1.28||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.28|0.66|0.3113
70966243|NCT01704287|141438821|SUPERIORITY_OR_OTHER_LEGACY|PD-L1 Positive Participants|Hazard Ratio (HR)|0.7||||0.0208|TWO_SIDED|95.0|0.5|0.99||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||0.99|0.50|0.0208
70966244|NCT01704287|141438821|SUPERIORITY_OR_OTHER_LEGACY|PD-L1 Positive Participants|Hazard Ratio (HR)|0.71||||0.0496|TWO_SIDED|95.0|0.5|1.0||Two-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.00|0.50|0.0496
70966245|NCT01704287|141438821|SUPERIORITY_OR_OTHER_LEGACY|PD-L1 Negative Participants|Hazard Ratio (HR)|1.07||||0.6043|TWO_SIDED|95.0|0.65|1.76||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.76|0.65|0.6043
70966246|NCT01704287|141438821|SUPERIORITY_OR_OTHER_LEGACY|PD-L1 Negative Participants|Hazard Ratio (HR)|0.62||||0.0335|TWO_SIDED|95.0|0.37|1.04||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.04|0.37|0.0335
70966247|NCT01704287|141438821|SUPERIORITY_OR_OTHER_LEGACY|PD-L1 Negative Participants|Hazard Ratio (HR)|0.71||||0.1504|TWO_SIDED|95.0|0.44|1.13||Two-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.13|0.44|0.1504
70966248|NCT04490395|141438831|SUPERIORITY||Mean Difference (Final Values)|1.68||||0.044|TWO_SIDED|95.0|-0.26|3.62|||t-test, 2 sided|||||3.62|-0.26|0.044
70966249|NCT04490395|141438832|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.056|TWO_SIDED|95.0|-0.15|1.33|||t-test, 2 sided|||||1.33|-0.15|0.056
70966250|NCT04490395|141438833|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.377|TWO_SIDED|95.0|-1.75|1.28|||t-test, 2 sided|||||1.28|-1.75|0.377
70966251|NCT04490395|141438834|SUPERIORITY|Within subjects change over time|F test (1,15) df|1.381||||0.258|TWO_SIDED||||||ANOVA|Change over time||Only 9 cases had any data available per group, and some had missing values and were not included in each analysis.|Within subjects change over time.|||0.258
70966252|NCT04490395|141438834|SUPERIORITY|Between group analysis|F test (1,15) df|0.246||||0.627|TWO_SIDED||||||ANOVA||||Between group analysis|||0.627
70966253|NCT04490395|141438834|SUPERIORITY||F test (1,15) df|0.005||||0.947|TWO_SIDED||||||ANOVA|||Time x Condition interaction|Time x Condition interaction|||0.947
70966254|NCT04490395|141438835|SUPERIORITY||Mean Difference (Final Values)|-0.88||||0.038|TWO_SIDED|95.0|-1.85|0.98|||t-test, 2 sided|||||0.98|-1.85|0.038
70966255|NCT04490395|141438836|SUPERIORITY||Mean Difference (Final Values)|-2.56||||0.07|TWO_SIDED|95.0|-6.05|0.94|||t-test, 2 sided|||||0.94|-6.05|0.07
70966256|NCT04490395|141438837|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.43|TWO_SIDED|95.0|-1.19|1.42|||t-test, 2 sided|||||1.42|-1.19|0.43
70966257|NCT04490395|141438838|SUPERIORITY||Mean Difference (Final Values)|-0.029||||0.72|TWO_SIDED|95.0|-0.194|1.42|||t-test, 2 sided|||||1.42|-.194|0.72
70966258|NCT04490395|141438839|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.341|TWO_SIDED|95.0|-0.35|0.23|||t-test, 2 sided|||||0.23|-0.35|0.341
70966259|NCT04490395|141438840|SUPERIORITY||Mean Difference (Final Values)|-0.059||||0.25|TWO_SIDED|95.0|-2.35|1.17|||t-test, 2 sided|||||1.17|-2.35|0.25
70966260|NCT01462435|141438861|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|446.946|STANDARD_ERROR_OF_MEAN|122.2935|<|0.001|TWO_SIDED|95.0|206.567|687.324|||ANCOVA|||||687.324|206.567|<0.001
70966261|NCT01462435|141438861|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|316.145|STANDARD_ERROR_OF_MEAN|121.5971||0.01|TWO_SIDED|95.0|77.136|555.155|||ANCOVA|||||555.155|77.136|0.010
70966262|NCT01462435|141438861|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|313.119|STANDARD_ERROR_OF_MEAN|122.5676||0.011|TWO_SIDED|95.0|72.202|554.037|||ANCOVA|||||554.037|72.202|0.011
70966263|NCT01462435|141438862|SUPERIORITY_OR_OTHER|||||||0.043||95.0|||||t-test, 2 sided|||||||0.043
70966264|NCT01462435|141438862|SUPERIORITY_OR_OTHER|||||||0.109||95.0|||||t-test, 2 sided|||||||0.109
70966265|NCT01462435|141438862|SUPERIORITY_OR_OTHER|||||||0.183||95.0|||||t-test, 2 sided|||||||0.183
70966266|NCT01462435|141438863|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|||||||0.009
70966267|NCT01462435|141438863|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||t-test, 2 sided|||||||0.029
70966268|NCT01462435|141438863|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||||||0.050
70966269|NCT01462435|141438864|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
70966270|NCT01462435|141438864|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
70966271|NCT01462435|141438864|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
70966272|NCT01462435|141438865|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|||||||0.009
70966273|NCT01462435|141438865|SUPERIORITY_OR_OTHER|||||||0.091||95.0|||||t-test, 2 sided|||||||0.091
70966274|NCT01462435|141438865|SUPERIORITY_OR_OTHER|||||||0.053||95.0|||||t-test, 2 sided|||||||0.053
70966275|NCT01462435|141438866|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||||||0.002
70966276|NCT01462435|141438866|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||t-test, 2 sided|||||||0.026
70966277|NCT01462435|141438866|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||t-test, 2 sided|||||||0.017
70966278|NCT01462435|141438867|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
70966279|NCT01462435|141438867|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||||||0.005
70966280|NCT01462435|141438867|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
70966281|NCT01462435|141438868|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
70966282|NCT01462435|141438868|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
70966283|NCT01462435|141438868|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
70966284|NCT00857532|141438873|SUPERIORITY_OR_OTHER|||||||0.021||95.0|||||Spearman's Rank Order Correlation|||"P-value for Attention correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 attention score."||||0.021
70966285|NCT00857532|141438873|SUPERIORITY_OR_OTHER|||||||0.077||95.0|||||Spearman's Rank Order Correlation|||"P-value for Initiation/Perseveration correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 initiation/perseveration score."||||0.077
70966286|NCT00857532|141438873|SUPERIORITY_OR_OTHER|||||||0.364||95.0|||||Spearman's Rank Order Correlation|||"P-value for Construction correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 construction score."||||0.364
70966287|NCT00857532|141438873|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||Spearman's Rank Order Correlation|||"P-value for Conceptualization correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 conceptualization score."||||0.266
70966288|NCT00857532|141438873|SUPERIORITY_OR_OTHER|||||||0.152||95.0|||||Spearman's Rank Order Correlation|||"P-value for Memory correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 memory score."||||0.152
70966289|NCT00857532|141438873|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||Spearman's Rank Order Correlation|||"P-value for DRS-2 Total correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 total score."||||0.041
70966290|NCT00857532|141438874|SUPERIORITY_OR_OTHER|||||||0.0411||95.0|||||Spearman's Rank Order Correlation|||"P-value for Amyloid beta correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and amyloid beta."||||0.0411
70966291|NCT00857532|141438874|SUPERIORITY_OR_OTHER|||||||0.58||95.0|||||Spearman's Rank Order Correlation|||"P-value for Tau correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and tau."||||0.5800
70966292|NCT00857532|141438874|SUPERIORITY_OR_OTHER|||||||0.8164||95.0|||||Spearman's Rank Order Correlation|||"P-value for Phospho-Tau correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and phospho-tau."||||0.8164
70966293|NCT02573870|141438875|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|p-values were not presented as non-inferiority was assessed by confidence interval (CI).|Mean Difference (Final Values)|-2.245|||||TWO_SIDED|95.0|-6.153|1.663|||||Treatment difference is calculated as active minus placebo and the non-inferiority bound was 10 bpm for Day 42|||1.663|-6.153|
70966294|NCT00257725|141438876|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.09|STANDARD_DEVIATION|0.73||0.01|TWO_SIDED|95.0|||||paired t-test|||||||0.01
70966295|NCT00257725|141438877|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.64|STANDARD_DEVIATION|1.29||0.01|TWO_SIDED|95.0|||||paired t-test|||||||0.01
70966296|NCT00257725|141438878|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.55|STANDARD_DEVIATION|7.7||0.01|TWO_SIDED|95.0|||||paired t-test|||||||0.01
70966297|NCT00806195|141438891|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis associated with the safety objective was that the upper limit of the two-sided 95% CI for this difference in the proportion of subjects experiencing at least one severe systemic reaction during the first 7 days after any vaccination (PMenACWY+Routine Vaccines-PRoutine Vaccines) was ≥ 6%.|Mean Difference (Final Values)|3.0|||||TWO_SIDED|95.0|-0.8|6.4|||Miettinen and Nurminen|||MenACWY-CRM 197 administered concomitantly with routine vaccines was considered noninferior to routine vaccines alone with respect to severe systemic reactions if the upper limit of the 2-sided 95% CI of the difference (MenACWY-CRM197 vaccine plus routine vaccines group minus routine vaccines only group) in the proportion of subjects experiencing at least one severe systemic reaction during the first 7 days (days 1-7) after any vaccination was \<6%.||6.4|-0.8|
70966298|NCT00806195|141438892|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis associated with the SAE safety objective was that the upper limit of the two-sided 95% confidence interval for the difference between the MenACWY and routine vaccine groups in the proportion of subjects experiencing at least one SAE (PMenACWY + Routine Vaccines - PRoutine Vaccines) was ≥5%.|Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.9|1.5|||Miettinen and Nurminen|||MenACWY-CRM 197 administered concomitantly with routine vaccines was considered non inferior to routine vaccines alone with respect to serious adverse events if the upper limit of the 2-sided 95% CI of the difference (MenACWY vaccine plus routine vaccines group minus routine vaccines only group) of the proportion of subjects experiencing at least one serious adverse event was \<5%.||1.5|-0.9|
70966299|NCT00806195|141438892|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis associated with the SAE safety objective was that the upper limit of the two-sided 95% confidence interval for the difference between the MenACWY and routine vaccine groups in the proportion of subjects experiencing at least one SAE (PMenACWY + Routine Vaccines - PRoutine Vaccines) was \<5%.|Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.8|1.3|||Miettinen and Nurminen|||MenACWY-CRM 197 administered concomitantly with routine vaccines was considered non inferior to routine vaccines alone with respect to serious adverse events if the upper limit of the 2-sided 95% CI of the difference (MenACWY vaccine plus routine vaccines group minus routine vaccines only group) of the proportion of subjects experiencing at least one serious adverse event was \<5%.||1.3|-0.8|
70966300|NCT00139776|141438912|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANOVA|Treatment as fixed effect||"Null hypothesis for primary outcome is that there is no difference in the number of flares observed between the 2 treatment arms of celecoxib 200mg continuous use and celecoxib 200mg intermittent use.~Sample size calculation: Sufficient number of participants were randomized to provide at least 80% power to detect an estimated effect size of 0.2 using a 2-sided t-test at a 0.05 significant level."||||<0.0001
70966301|NCT00139776|141438913|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|Log Rank|||Kaplan-Meier analysis||||<0.0001
70966302|NCT00139776|141438914|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANOVA|Treatment as fixed effect||||||<0.0001
70966303|NCT00139776|141438915|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANOVA|Treatment as fixed effect||||||<0.0001
70966304|NCT00139776|141438916|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 4||||<0.001
70966305|NCT00139776|141438916|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 8||||<0.001
70966306|NCT00139776|141438916|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 12||||<0.001
70966307|NCT00139776|141438916|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 16||||0.003
70966308|NCT00139776|141438916|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 20||||0.022
70966309|NCT00139776|141438916|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 24||||0.047
70966310|NCT00139776|141438917|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 4||||<0.001
70966311|NCT00139776|141438917|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 8||||0.001
70966312|NCT00139776|141438917|SUPERIORITY_OR_OTHER_LEGACY|||||||0.096||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 12||||0.096
70966313|NCT00139776|141438917|SUPERIORITY_OR_OTHER_LEGACY|||||||0.338||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 16||||0.338
70966314|NCT00139776|141438917|SUPERIORITY_OR_OTHER_LEGACY|||||||0.832||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 20||||0.832
70966315|NCT00139776|141438917|SUPERIORITY_OR_OTHER_LEGACY|||||||0.972||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 24||||0.972
70966316|NCT00139776|141438918|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0046||95.0||||Overall p-value Threshold for statistical significance p\<0.05|Cochran-Mantel-Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.0046
70966317|NCT00139776|141438919|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0102||95.0||||Threshold for statistical significance p\<0.05|ANOVA|Treatment as fixed effect||||||0.0102
70966318|NCT00139776|141438920|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012||95.0||||Threshold for statistical significance p\<0.05|ANOVA|Treatment as fixed effect||||||0.0012
70966319|NCT00139776|141438921|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANOVA|Treatment as fixed effect||||||<0.0001
70966320|NCT00139776|141438922|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Total WOMAC score||||<0.001
70966321|NCT00139776|141438922|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|0.71||||95.0|0.21|2.99|||||Change in LSmean (score at end of Period III minus score at start of Period III)|Total WOMAC score - Continuous use||2.99|0.21|
70966322|NCT00139776|141438922|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.99|STANDARD_ERROR_OF_MEAN|0.71||||95.0|3.6|6.38|||||Change in LSmean (score at end of Period III minus score at start of Period III)|Total WOMAC score - Intermittent use||6.38|3.60|
70966323|NCT00139776|141438922|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC pain subscale||||<0.001
70966324|NCT00139776|141438922|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.15||||95.0|0.06|0.67|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC pain subscale - Continuous use||0.67|0.06|
70966325|NCT00139776|141438922|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.18|STANDARD_ERROR_OF_MEAN|0.15||||95.0|0.88|1.49|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC pain subscale - Intermittent use||1.49|0.88|
70966326|NCT00139776|141438922|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC stiffness subscale||||0.004
70966327|NCT00139776|141438922|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.07||||95.0|-0.02|0.25|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC stiffness subscale - Continuous use||0.25|-0.02|
70966328|NCT00139776|141438922|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.07||||95.0|0.26|0.53|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC stiffness subscale - Intermittent use||0.53|0.26|
70966329|NCT00139776|141438922|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC physical function subscale||||0.002
70966330|NCT00139776|141438922|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.13|STANDARD_ERROR_OF_MEAN|0.51||||95.0|0.13|2.14|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC physical function subscale - Continuous use||2.14|0.13|
70966331|NCT00139776|141438922|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.43|STANDARD_ERROR_OF_MEAN|0.51||||95.0|2.42|4.43|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC physical function subscale - Intermittent use||4.43|2.42|
70966332|NCT00139776|141438923|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2712||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Sleep disturbance||||0.2712
70966333|NCT00139776|141438923|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8737||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Snoring||||0.8737
70966334|NCT00139776|141438923|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7703||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Awaken short of breath||||0.7703
70966335|NCT00139776|141438923|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3769||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Quantity of sleep||||0.3769
70966336|NCT00139776|141438923|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4075||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Sleep adequacy||||0.4075
70966337|NCT00139776|141438923|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5854||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Somnolence||||0.5854
70966338|NCT00139776|141438923|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8358||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Sleep problems index I||||0.8358
70966339|NCT00139776|141438923|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5878||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Sleep problems index II||||0.5878
70903846|NCT01316770|141296453|OTHER|||||||0.625|||||||McNemar|||"McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 28 is equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 28 is not equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28."||||0.625
70903847|NCT01316770|141296453|OTHER|||||||0.5|||||||McNemar|||"McNemar's test on the study Day 42 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 42 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 42.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 42 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 42."||||0.5000
70903848|NCT01316770|141296453|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 56 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 56 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 56.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 56 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 56."||||1.000
70903849|NCT01672853|141296495|SUPERIORITY||Difference in LS Mean|-0.4|||||TWO_SIDED|95.0|-2.3|1.6||||||A mixed-effect model for repeated measures (MMRM) with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% confidence interval (CI) for the treatment difference between each treatment arm and placebo in least squares mean (LSMean) change from baseline in MQC at Week 96. With MMRM setting, all participants with available data from the 3 treatment groups with change in MQC at Week 48 and/or Week 96 contributed to the overall model.||1.6|-2.3|
70903850|NCT01672853|141296495|SUPERIORITY||Difference in LS Mean|1.0|||||TWO_SIDED|95.0|-1.0|3.0||||||A MMRM with an unstructured variancecovariance matrix for each participant was used to calculate a point estimate and a 95% CI for the treatment difference between each treatment arm and placebo in LSMean change from baseline in MQC at Week 96. With MMRM setting, all participants with available data from the 3 treatment groups with change in MQC at Week 48 and/or Week 96 contributed to the overall model.||3.0|-1.0|
70903851|NCT05473000|141296513|SUPERIORITY|||||||0.092|||||||t-test, 2 sided|||||||0.092
70903852|NCT01265030|141296514|SUPERIORITY||Mean Difference (Net)|0.75||||0.63|TWO_SIDED|95.0|-2.54|4.04|||t-test, 2 sided|||||4.04|-2.54|0.63
70903853|NCT01265030|141296514|SUPERIORITY||Mean Difference (Net)|-1.95||||0.31|TWO_SIDED|95.0|-6.08|2.19|||t-test, 2 sided|||||2.19|-6.08|0.31
70903854|NCT01265030|141296515|SUPERIORITY||Mean Difference (Net)|0.063||||0.68|TWO_SIDED|95.0|-0.286|0.411|||t-test, 2 sided|||The mean difference in pain score at week 1 and before surgery||0.411|-.286|0.68
70903855|NCT01590771|141296527|SUPERIORITY_OR_OTHER||Robust regression|-0.61|||<|0.001|TWO_SIDED|95.0|-0.77|-0.44||The ANCOVA model controlled for treatment, metformin strata (on or not on metformin), and baseline A1C value.|ANCOVA||Based on robust regression using M-estimation with terms for treatment, metformin strata (on or not on metformin), and baseline A1C value.|||-0.44|-0.77|<0.001
70903856|NCT01590771|141296528|SUPERIORITY_OR_OTHER||Difference in least squares mean|-32.9|||<|0.001|TWO_SIDED|95.0|-45.4|-20.4||The ANCOVA model controlled for treatment, metformin strata (on or not on metformin), and baseline 2-hr PMG value.|ANCOVA|||||-20.4|-45.4|<0.001
70903857|NCT01590771|141296529|SUPERIORITY_OR_OTHER||Estimate difference|-16.8|||<|0.001|TWO_SIDED|95.0|-23.3|-10.2||Based on robust regression using M-estimation with terms for treatment, metformin strata (on or not on metformin), and baseline FPG value.|Robust regression|||||-10.2|-23.3|<0.001
70903858|NCT01590771|141296530|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.41|||<|0.001|TWO_SIDED|95.0|-0.63|-0.2||The ANCOVA model controlled for treatment and baseline A1C value.|ANCOVA|||||-0.20|-0.63|<0.001
70903859|NCT01590771|141296531|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.8|||<|0.001|TWO_SIDED|95.0|-1.07|-0.53||The ANCOVA model controlled for treatment and baseline A1C value.|ANCOVA|||||-0.53|-1.07|<0.001
70903860|NCT01590771|141296532|SUPERIORITY_OR_OTHER||Estimate difference|-27.2|||<|0.001|TWO_SIDED|95.0|-41.2|-13.2||Based on robust regression using M-estimation with terms for treatment and baseline 2-hr PMG value.|Robust regression|||||-13.2|-41.2|<0.001
70903861|NCT01590771|141296533|SUPERIORITY_OR_OTHER||Difference in least squares mean|-37.7|||<|0.001|TWO_SIDED|95.0|-56.9|-18.4||The ANCOVA model controlled for treatment and baseline 2-hr PMG value.|ANCOVA|||||-18.4|-56.9|<0.001
70903862|NCT01590771|141296534|SUPERIORITY_OR_OTHER||Estimate Difference|-16.5|||<|0.001|TWO_SIDED|95.0|-25.3|-7.8||Based on robust regression using M-estimation with terms for treatment and baseline FPG value.|Robust Regression|||||-7.8|-25.3|<0.001
70903863|NCT01590771|141296535|SUPERIORITY_OR_OTHER||Estimate Difference|-17.0|||<|0.001|TWO_SIDED|95.0|-26.9|-7.1||Based on robust regression using M-estimation with terms for treatment and baseline FPG value.|Robust Regression|||||-7.1|-26.9|<0.001
70903864|NCT00840996|141296548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|97.5|-1.23|-0.4||Test for superiority adjusted for 2 primary comparisons (2 outcomes)|Mixed Models Analysis|Llinear mixed-effects accounts for correlation exhibited by the repeated pain measurements on a given patient (spatial power correlation structure).||Postoperative analgesia was characterized using both pain scores and opioid consumption .We considered one of the groups to be better than the other on postoperative pain control with superiority on either outcome, in the presence of noninferiority on both outcomes. Thus, our primary hypothesis was assessed in a joint hypothesis testing framework .||-0.40|-1.23|<0.001
70903865|NCT00840996|141296549|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin: ratio of the geometric means not more than 1.3 greater (mean mg IV morphine equivalent not more than 30% greater ) than that of the other group|the ratio of the geometric means|0.8||||0.011|TWO_SIDED|95.0|0.65|1.21||Noninferiority hypotheses were evaluated against a one-sided significance criterion of 0.025 \[adjusting for testing in both directions: lidocaine vs. control and vs. control vs. lidocaine \]|Regression, Linear|Log-linear regression model was used; 0.1 mg added before taking the logarithm to accommodate the 2 patients who received 0 mg opioids.||Postoperative analgesia was characterized using both pain scores and opioid consumption .We considered one of the groups to be better than the other on postoperative pain control with superiority on either outcome, in the presence of noninferiority on both outcomes. Thus, our primary hypothesis was assessed in a joint hypothesis testing framework .||1.21|0.65|0.011
70966340|NCT00139776|141438924|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC total score||||<0.001
70966341|NCT00139776|141438924|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC pain subscale||||<0.001
70966342|NCT00139776|141438924|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC stiffness subscale||||<0.001
70966343|NCT00139776|141438924|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC physical function subscale||||<0.001
70966344|NCT00139776|141438925|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1437||95.0||||Threshold for statistical significance p\<0.05|Cochran-Mantel-Haenszel|by general association||Analysis across all 3 sleep scores for Period III||||0.1437
70966345|NCT00139776|141438926|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Physical function||||<0.0001
70966346|NCT00139776|141438926|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Role physical||||<0.0001
70966347|NCT00139776|141438926|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Bodily pain||||<0.0001
70966348|NCT00139776|141438926|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3097||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||General health||||0.3097
70966349|NCT00139776|141438926|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0139||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Vitality||||0.0139
70966350|NCT00139776|141438926|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1303||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Social functioning||||0.1303
70966351|NCT00139776|141438926|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1404||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Role emotional||||0.1404
70903866|NCT00840996|141296550|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.049|TWO_SIDED|95.0|0.84|1.0|||Regression, Logistic|||||1.00|0.84|0.049
70903867|NCT00840996|141296551|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.31|TWO_SIDED|95.0|0.77|1.09|||Regression, Logistic|||Nausea - POD 2||1.09|0.77|0.31
70903868|NCT00840996|141296551|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.44|TWO_SIDED|95.0|0.94|1.14|||Regression, Logistic|||Vomiting - POD 2||1.14|0.94|0.44
70903869|NCT00840996|141296552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.15|TWO_SIDED|95.0|-2.4|0.4|||Regression, Linear|||||0.4|-2.4|0.15
70903870|NCT00840996|141296553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2||||0.002|TWO_SIDED|95.0|2.3|10.0|||Regression, Linear|||||10|2.3|0.002
70903871|NCT00840996|141296554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6||||0.04|TWO_SIDED|95.0|0.3|8.9|||Regression, Logistic|||||8.9|0.3|0.04
70903872|NCT03285295|141296567|SUPERIORITY||Clinical Specificity (%)|99.96|||||TWO_SIDED|95.0|99.92|99.99|||Binomial Distribution|Specificity sample size is a minimum of 15,000 donors.||||99.99|99.92|
70903873|NCT03285295|141296568|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|99.15|100.0|||Sensitivity|||||100.00|99.15|
70903874|NCT03285295|141296569|SUPERIORITY||Clinical Specificity (%)|99.99|||||TWO_SIDED|95.0|99.95|100.0|||Binomial Distribution|||||100.00|99.95|
70903875|NCT03285295|141296570|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|99.48|100.0|||Sensitivity|||||100.00|99.48|
70903876|NCT03285295|141296571|SUPERIORITY||Clinical Specificity (%)|99.92|||||TWO_SIDED|95.0|99.86|99.95|||Binomial Distribution|||||99.95|99.86|
70903877|NCT03285295|141296572|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|99.09|100.0|||Sensitivity|||||100.00|99.09|
70903878|NCT03285295|141296573|SUPERIORITY||Clinical Specificity (%)|99.92|||||TWO_SIDED|95.0|99.87|99.96|||Binomial Exact|||||99.96|99.87|
70903879|NCT03285295|141296574|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|99.72|100.0|||Sensitivity|||||100.00|99.72|
70903880|NCT03285295|141296575|SUPERIORITY||Clinical Specificity (%)|99.9|||||TWO_SIDED|95.0|99.84|99.94|||Binomial Exact|||||99.94|99.84|
70903881|NCT03285295|141296576|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|99.09|100.0|||Sensitivity|||||100.00|99.09|
70903882|NCT03285295|141296577|SUPERIORITY||Clinical Specificity (%)|99.98|||||TWO_SIDED|95.0|99.94|100.0|||Binomial Exact|||||100.00|99.94|
70903883|NCT03285295|141296578|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|98.85|100.0|||Sensitivity|||||100.00|98.85|
70903884|NCT03285295|141296583|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|95.98|100.0|||Sensitivity|||Sensitivity||100.00|95.98|
70903885|NCT03285295|141296585|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|92.75|100.0|||Sensitivity|||Sensitivity||100.00|92.75|
70903886|NCT03285295|141296586|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|94.87|100.0|||Sensitivity|||Sensitivity||100.00|94.87|
70903887|NCT03285295|141296587|OTHER|95% Confidence Interval provided.|Point Estimate|98.65|||||TWO_SIDED|95.0|95.2|99.84|||Sensitivity|||Sensitivity||99.84|95.20|
70966352|NCT00139776|141438926|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4015||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Mental health||||0.4015
70966353|NCT00139776|141438926|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Physical component summary||||<0.0001
70966354|NCT00139776|141438926|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0301||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Mental component summary||||0.0301
70966355|NCT03861936|141438940|SUPERIORITY||Percentage Difference|68.8|||<|0.0001|TWO_SIDED|95.0|54.5|83.1||P-values for between-treatment comparisons are based on Cochran-Mantel-Haenszel (CMH) model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||83.1|54.5|<.0001
70966356|NCT03861936|141438940|SUPERIORITY||Percentage Difference|69.6|||<|0.0001|TWO_SIDED|95.0|55.1|84.0||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||84.0|55.1|<.0001
70966357|NCT03861936|141438946|SUPERIORITY||Percentage Difference|48.4|||<|0.0001|TWO_SIDED|95.0|33.1|63.7||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||63.7|33.1|<.0001
70966358|NCT03861936|141438946|SUPERIORITY||Percentage Difference|45.7|||<|0.0001|TWO_SIDED|95.0|29.5|61.8||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||61.8|29.5|<.0001
70966359|NCT03861936|141438947|SUPERIORITY||Percentage Difference|55.2|||<|0.0001|TWO_SIDED|95.0|39.6|70.8||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||70.8|39.6|<.0001
70966360|NCT03861936|141438947|SUPERIORITY||Percentage Difference|60.9|||<|0.0001|TWO_SIDED|95.0|45.1|76.7||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||76.7|45.1|<.0001
70966361|NCT03861936|141438948|SUPERIORITY||Percentage Difference|54.2|||<|0.0001|TWO_SIDED|95.0|37.9|70.5||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||70.5|37.9|<.0001
70966362|NCT03861936|141438948|SUPERIORITY||Percentage Difference|47.8|||<|0.0001|TWO_SIDED|95.0|30.1|65.6||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||65.6|30.1|<.0001
70966363|NCT03861936|141438949|SUPERIORITY||Percentage Difference|68.8|||<|0.0001|TWO_SIDED|95.0|54.5|83.1||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||83.1|54.5|<.0001
70966364|NCT03861936|141438949|SUPERIORITY||Percentage Difference|52.2|||<|0.0001|TWO_SIDED|95.0|34.8|69.6||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||69.6|34.8|<.0001
70966365|NCT03861936|141438950|SUPERIORITY||Least Squares (LS) Mean Difference|-5.82|STANDARD_ERROR_OF_MEAN|0.647|<|0.0001|TWO_SIDED|95.0|-7.1|-4.54||The change from baseline was analyzed using ANCOVA with study intervention and investigator site as factors and baseline MMPS Grade as a covariate.|ANCOVA|||||-4.54|-7.10|<.0001
70966366|NCT03861936|141438950|SUPERIORITY||LS Mean Difference|-5.81|STANDARD_ERROR_OF_MEAN|0.678|<|0.0001|TWO_SIDED|95.0|-7.15|-4.47||The change from baseline was analyzed using ANCOVA with study intervention and investigator site as factors and baseline MMPS Grade as a covariate.|ANCOVA|||||-4.47|-7.15|<.0001
70966367|NCT03861936|141438951|SUPERIORITY||LS Mean Difference|-7.63|STANDARD_ERROR_OF_MEAN|0.756|<|0.0001|TWO_SIDED|95.0|-9.12|-6.13||The change from baseline was analyzed using ANCOVA with study intervention and investigator site as factors and baseline MMPS Grade as a covariate.|ANCOVA|||||-6.13|-9.12|<.0001
70966368|NCT03861936|141438951|SUPERIORITY||LS Mean Difference|-8.26|STANDARD_ERROR_OF_MEAN|0.793|<|0.0001|TWO_SIDED|95.0|-9.83|-6.69||The change from baseline was analyzed using ANCOVA with study intervention and investigator site as factors and baseline MMPS Grade as a covariate.|ANCOVA|||||-6.69|-9.83|<.0001
70966369|NCT00701090|141438978|NON_INFERIORITY_OR_EQUIVALENCE|The pre-specified non-inferiority margin was 0.4%, i.e., Sitagliptin was declared non-inferior to glimepiride if the upper limit of the two-sided 95% confidence interval for the between group difference (sitagliptin minus glimepiride) was less than 0.4%|Mean Difference (Net)|0.07|STANDARD_DEVIATION|0.7|||TWO_SIDED|95.0|-0.03|0.16|||||ANCOVA model with terms: treatment, country, and baseline HbA1c.|||0.16|-0.03|
70966370|NCT00701090|141438979|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9|STANDARD_DEVIATION|28.8|||TWO_SIDED|95.0|-0.9|6.7|||||ANCOVA model terms: treatment, country, and baseline.|||6.7|-0.9|
70966371|NCT00701090|141438980|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-15.0|||<|0.001|TWO_SIDED|95.0|-19.3|-10.9|||Miettinen &Nurminen method||Miettinen \&Nurminen method was used for the 95% confidence interval|||-10.9|-19.3|<0.001
70966372|NCT00701090|141438981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|STANDARD_DEVIATION|2.9|<|0.001|TWO_SIDED|95.0|-2.3|-1.6|||ANCOVA|Model terms: treatment, country, and baseline.|ANCOVA model terms: treatment, country, and baseline.|||-1.6|-2.3|<0.001
70966373|NCT00701090|141438982|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.47|0.9|||||The parameter estimate and 95% CI represent the odds of having A1C \<7.0% at Week 30 in the Sitagliptin group vs. the Glimepiride group, computed using a logistic regression model controlling for treatment, country and baseline A1C.|||0.90|0.47|
70966374|NCT00701090|141438983|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.47|0.95|||||The parameter estimate and 95% CI represent the odds of having A1C \<6.5% at Week 30 in the Sitagliptin group vs. the Glimepiride group, computed using a logistic regression model controlling for treatment, country and baseline A1C.|||0.95|0.47|
70903888|NCT04867785|141296596|SUPERIORITY||Least Squares (LS) Mean Difference|-0.38||||0.188|TWO_SIDED|95.0|-0.94|0.18|||Mixed Models Analysis|||||0.18|-0.94|0.188
70903889|NCT04867785|141296596|SUPERIORITY||LSMean Difference|-1.34|||<|0.001|TWO_SIDED|95.0|-1.84|-0.85|||Mixed Models Analysis|||||-0.85|-1.84|<0.001
70903890|NCT04867785|141296596|SUPERIORITY||LSMean Difference|-1.25|||<|0.001|TWO_SIDED|95.0|-1.85|-0.65|||Mixed Models Analysis|||||-0.65|-1.85|<0.001
70903891|NCT04867785|141296596|SUPERIORITY||LSMean Difference|-1.94|||<|0.001|TWO_SIDED|95.0|-2.44|-1.43|||Mixed Models Analysis|||||-1.43|-2.44|<0.001
70903892|NCT04867785|141296596|SUPERIORITY||LSMean Difference|-1.83|||<|0.001|TWO_SIDED|95.0|-2.42|-1.24|||Mixed Models Analysis|||||-1.24|-2.42|<0.001
70966375|NCT03962738|141439019|SUPERIORITY||Odds Ratio (OR)|3.46|||<|0.001|TWO_SIDED|95.0|2.17|5.54|||Regression, Logistic|||||5.54|2.17|<0.001
70966376|NCT03962738|141439020|SUPERIORITY||||||<|0.001|||||||Cochran-Armitage Trend Test|||||||<.001
70966377|NCT03962738|141439021|SUPERIORITY||Odds Ratio (OR)|1.76||||0.037|TWO_SIDED|95.0|1.03|2.99|||Regression, Logistic|||||2.99|1.03|0.037
70966378|NCT03962738|141439021|SUPERIORITY||Odds Ratio (OR)|3.34|||<|0.001|TWO_SIDED|95.0|2.16|5.17|||Regression, Logistic|||||5.17|2.16|<0.001
70966379|NCT03962738|141439021|SUPERIORITY||Odds Ratio (OR)|2.95|||<|0.001|TWO_SIDED|95.0|1.89|4.62|||Regression, Logistic|||||4.62|1.89|<0.001
70966380|NCT03962738|141439022|SUPERIORITY||Odds Ratio (OR)|1.49||||0.197|TWO_SIDED|95.0|0.81|2.72|||Regression, Logistic|||||2.72|0.81|0.197
70966381|NCT03962738|141439022|SUPERIORITY||Odds Ratio (OR)|1.59||||0.044|TWO_SIDED|95.0|1.01|2.5|||Regression, Logistic|||||2.50|1.01|0.044
70966382|NCT03962738|141439022|SUPERIORITY||Odds Ratio (OR)|1.75||||0.023|TWO_SIDED|95.0|1.08|2.83|||Regression, Logistic|||||2.83|1.08|0.023
70966383|NCT03962738|141439023|SUPERIORITY||Odds Ratio (OR)|1.52||||0.268|TWO_SIDED|95.0|0.73|3.17|||Regression, Logistic|||||3.17|0.73|0.268
70966384|NCT03962738|141439023|SUPERIORITY||Odds Ratio (OR)|2.19||||0.006|TWO_SIDED|95.0|1.26|3.82|||Regression, Logistic|||||3.82|1.26|0.006
70966385|NCT03962738|141439023|SUPERIORITY||Odds Ratio (OR)|2.63|||<|0.001|TWO_SIDED|95.0|1.5|4.61|||Regression, Logistic|||||4.61|1.50|<0.001
70966386|NCT03962738|141439024|SUPERIORITY||Odds Ratio (OR)|1.26||||0.535|TWO_SIDED|95.0|0.61|2.58|||Regression, Logistic|||||2.58|0.61|0.535
70966387|NCT03962738|141439024|SUPERIORITY||Odds Ratio (OR)|1.77||||0.036|TWO_SIDED|95.0|1.04|3.03|||Regression, Logistic|||||3.03|1.04|0.036
70966388|NCT03962738|141439024|SUPERIORITY||Odds Ratio (OR)|1.93||||0.018|TWO_SIDED|95.0|1.12|3.33|||Regression, Logistic|||||3.33|1.12|0.018
70966389|NCT03962738|141439025|SUPERIORITY||Odds Ratio (OR)|1.67||||0.199|TWO_SIDED|95.0|0.76|3.65|||Regression, Logistic|||||3.65|0.76|0.199
70966390|NCT03962738|141439025|SUPERIORITY||Odds Ratio (OR)|1.33||||0.305|TWO_SIDED|95.0|0.77|2.32|||Regression, Logistic|||||2.32|0.77|0.305
70966391|NCT03962738|141439025|SUPERIORITY||Odds Ratio (OR)|1.26||||0.426|TWO_SIDED|95.0|0.71|2.24|||Regression, Logistic|||||2.24|0.71|0.426
70966392|NCT03962738|141439026|SUPERIORITY||Odds Ratio (OR)|1.57||||0.135|TWO_SIDED|95.0|0.87|2.82|||Regression, Logistic|||||2.82|0.87|0.135
70966393|NCT03962738|141439026|SUPERIORITY||Odds Ratio (OR)|1.48||||0.08|TWO_SIDED|95.0|0.95|2.3|||Regression, Logistic|||||2.30|0.95|0.080
70966394|NCT03962738|141439026|SUPERIORITY||Odds Ratio (OR)|1.56||||0.061|TWO_SIDED|95.0|0.98|2.49|||Regression, Logistic|||||2.49|0.98|0.061
70966395|NCT03962738|141439027|SUPERIORITY||Odds Ratio (OR)|1.38||||0.342|TWO_SIDED|95.0|0.71|2.67|||Regression, Logistic|||||2.67|0.71|0.342
70966396|NCT03962738|141439027|SUPERIORITY||Odds Ratio (OR)|1.25||||0.377|TWO_SIDED|95.0|0.76|2.04|||Regression, Logistic|||||2.04|0.76|0.377
70966397|NCT03962738|141439027|SUPERIORITY||Odds Ratio (OR)|1.05||||0.862|TWO_SIDED|95.0|0.63|1.72|||Regression, Logistic|||||1.72|0.63|0.862
70966398|NCT03962738|141439029|SUPERIORITY||Odds Ratio (OR)|3.43||||0.112|TWO_SIDED|95.0|0.75|15.65|||Regression, Logistic|||||15.65|0.75|0.112
70966399|NCT03962738|141439029|SUPERIORITY||Odds Ratio (OR)|9.05|||<|0.001|TWO_SIDED|95.0|2.68|30.55|||Regression, Logistic|||||30.55|2.68|<0.001
70966400|NCT03962738|141439029|SUPERIORITY||Odds Ratio (OR)|10.19|||<|0.001|TWO_SIDED|95.0|3.01|34.55|||Regression, Logistic|||||34.55|3.01|<0.001
70966401|NCT03962738|141439030|SUPERIORITY||Odds Ratio (OR)|0.78||||0.343|TWO_SIDED|95.0|0.46|1.31|||Regression, Logistic|||||1.31|0.46|0.343
70966402|NCT03962738|141439030|SUPERIORITY||Odds Ratio (OR)|2.02|||<|0.001|TWO_SIDED|95.0|1.37|2.98|||Regression, Logistic|||||2.98|1.37|<0.001
70966403|NCT03962738|141439030|SUPERIORITY||Odds Ratio (OR)|2.13|||<|0.001|TWO_SIDED|95.0|1.42|3.2|||Regression, Logistic|||||3.20|1.42|<0.001
70966404|NCT03962738|141439031|SUPERIORITY||Odds Ratio (OR)|1.19||||0.605|TWO_SIDED|95.0|0.62|2.26|||Regression, Logistic|||||2.26|0.62|0.605
70966405|NCT03962738|141439031|SUPERIORITY||Odds Ratio (OR)|1.8||||0.015|TWO_SIDED|95.0|1.12|2.9|||Regression, Logistic|||||2.90|1.12|0.015
70966406|NCT03962738|141439031|SUPERIORITY||Odds Ratio (OR)|1.23||||0.432|TWO_SIDED|95.0|0.74|2.05|||Regression, Logistic|||||2.05|0.74|0.432
70966407|NCT03962738|141439032|SUPERIORITY||Odds Ratio (OR)|1.77||||0.166|TWO_SIDED|95.0|0.79|3.96|||Regression, Logistic|||||3.96|0.79|0.166
70966408|NCT03962738|141439032|SUPERIORITY||Odds Ratio (OR)|1.34||||0.396|TWO_SIDED|95.0|0.68|2.62|||Regression, Logistic|||||2.62|0.68|0.396
70966409|NCT03962738|141439032|SUPERIORITY||Odds Ratio (OR)|1.58||||0.181|TWO_SIDED|95.0|0.81|3.11|||Regression, Logistic|||||3.11|0.81|0.181
70966410|NCT03962738|141439033|SUPERIORITY||Odds Ratio (OR)|1.44||||0.233|TWO_SIDED|95.0|0.79|2.64|||Regression, Logistic|||||2.64|0.79|0.233
70966411|NCT03962738|141439033|SUPERIORITY||Odds Ratio (OR)|1.5||||0.092|TWO_SIDED|95.0|0.94|2.41|||Regression, Logistic|||||2.41|0.94|0.092
70966412|NCT03962738|141439033|SUPERIORITY||Odds Ratio (OR)|1.8||||0.017|TWO_SIDED|95.0|1.11|2.92|||Regression, Logistic|||||2.92|1.11|0.017
70966413|NCT03962738|141439034|SUPERIORITY|||||||0.724|||||||ANCOVA|||||||0.724
70966414|NCT03962738|141439034|SUPERIORITY|||||||0.24|||||||ANCOVA|||||||0.240
70966415|NCT03962738|141439034|SUPERIORITY|||||||0.548|||||||ANCOVA|||||||0.548
70966416|NCT03962738|141439035|SUPERIORITY|||||||0.719|||||||ANCOVA|||||||0.719
70966417|NCT03962738|141439035|SUPERIORITY|||||||0.823|||||||ANCOVA|||||||0.823
70966418|NCT03962738|141439035|SUPERIORITY|||||||0.612|||||||ANCOVA|||||||0.612
70966419|NCT03962738|141439036|SUPERIORITY||Odds Ratio (OR)|1.78||||0.037|TWO_SIDED|95.0|1.04|3.07|||Regression, Logistic|||||3.07|1.04|0.037
70966420|NCT03962738|141439036|SUPERIORITY||Odds Ratio (OR)|2.67|||<|0.001|TWO_SIDED|95.0|1.75|4.06|||Regression, Logistic|||||4.06|1.75|<.001
70966421|NCT03962738|141439036|SUPERIORITY||Odds Ratio (OR)|3.27|||<|0.001|TWO_SIDED|95.0|2.11|5.06|||Regression, Logistic|||||5.06|2.11|<.001
70966422|NCT03962738|141439037|SUPERIORITY|||||||0.162|||||||ANOVA|||Work Functioning||||0.162
70966423|NCT03962738|141439037|SUPERIORITY|||||||0.356|||||||ANOVA|||Social Functioning||||0.356
70966424|NCT03962738|141439037|SUPERIORITY|||||||0.696|||||||ANOVA|||Energy and Vitality||||0.696
70966425|NCT03962738|141439037|SUPERIORITY|||||||0.914|||||||ANOVA|||Feelings and Concerns||||0.914
70966426|NCT03962738|141439037|SUPERIORITY|||||||0.226|||||||ANOVA|||Migraine Symptoms||||0.226
70966427|NCT03962738|141439037|SUPERIORITY|||||||0.31|||||||ANOVA|||Work Functioning||||0.310
70966428|NCT03962738|141439037|SUPERIORITY|||||||0.684|||||||ANOVA|||Social Functioning||||0.684
70966429|NCT03962738|141439037|SUPERIORITY|||||||0.864|||||||ANOVA|||Energy and Vitality||||0.864
70966430|NCT03962738|141439037|SUPERIORITY|||||||0.412|||||||ANOVA|||Feelings and Concerns||||0.412
70966431|NCT03962738|141439037|SUPERIORITY|||||||0.025|||||||ANOVA|||Migraine Symptoms||||0.025
70966432|NCT03962738|141439037|SUPERIORITY|||||||0.619|||||||ANOVA|||Work Functioning||||0.619
70966433|NCT03962738|141439037|SUPERIORITY|||||||0.824|||||||ANOVA|||Social Functioning||||0.824
70966434|NCT03962738|141439037|SUPERIORITY|||||||0.476|||||||ANOVA|||Energy and Vitality||||0.476
70966435|NCT03962738|141439037|SUPERIORITY|||||||0.352|||||||ANOVA|||Feelings and Concerns||||0.352
70966436|NCT03962738|141439037|SUPERIORITY|||||||0.044|||||||ANOVA|||Migraine Symptoms||||0.044
70966437|NCT00509067|141439039|SUPERIORITY|||||||0.93||||||alpha set at P \< .05|Mixed Models Analysis|Time (0, 4, 8, 12, 16 wks) x Treatment (Drug, Placebo) Effect: F(1, 33)=0.01.||||||0.93
70966438|NCT00509067|141439040|SUPERIORITY|||||||0.23||||||alpha level set at .05|Mixed Models Analysis|Time (0, 8, 16 weeks) x Group (Drug, Placebo) Effect: F(1, 32.8)=1.48..||||||0.23
70966439|NCT00509067|141439040|SUPERIORITY|||||||0.23||||||alpha set at P\<0.05|Mixed Models Analysis|Time (0, 8, 16, weeks) x Group (Drug, Placebo) Effect: F(1, 32.8)=1.48.||||||0.23
70966440|NCT02247960|141439051|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.00
70966441|NCT00073528|141439163|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.019|TWO_SIDED|95.0|0.53|0.96||p-value is from stratified log-rank test, stratifying for site of disease and time since prior adjuvant endocrine therapy at screening|Log Rank||The estimate of the treatment Hazard Ratio wase based on the log-rank test.|||0.96|0.53|0.019
70966442|NCT00073528|141439164|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.019|TWO_SIDED|95.0|0.53|0.96||p-value is from stratified log-rank test, stratifying for site of disease and time since prior adjuvant endocrine therapy at screening|Log Rank||The estimate of the treatment Hazard Ratio was based on the log-rank test.|||0.96|0.53|0.019
70966443|NCT04305275|141439200|SUPERIORITY||Least Squares (LS) Mean Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.533||0.0491|TWO_SIDED|95.0|-2.14|0.0|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||||0.00|-2.14|0.0491
70966444|NCT04305275|141439201|SUPERIORITY||LS mean difference|-0.81|STANDARD_ERROR_OF_MEAN|0.398||0.0468|TWO_SIDED|95.0|-1.6|-0.01|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 8||-0.01|-1.60|0.0468
70966445|NCT04305275|141439201|SUPERIORITY||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.467||0.3124|TWO_SIDED|95.0|-1.41|0.46|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, Pre-dose||0.46|-1.41|0.3124
70966446|NCT04305275|141439201|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.605||0.5148|TWO_SIDED|95.0|-1.61|0.81|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, 5 Hours Post-dose||0.81|-1.61|0.5148
70966447|NCT04305275|141439201|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.59||0.6452|TWO_SIDED|95.0|-1.45|0.91|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, 8 Hours Post-dose||0.91|-1.45|0.6452
70966448|NCT04305275|141439201|SUPERIORITY||LS mean difference|-0.77|STANDARD_ERROR_OF_MEAN|0.482||0.1171|TWO_SIDED|95.0|-1.73|0.2|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 22||0.20|-1.73|0.1171
70966449|NCT04305275|141439201|SUPERIORITY||LS mean difference|0.62|STANDARD_ERROR_OF_MEAN|0.557||0.2724|TWO_SIDED|95.0|-0.5|1.73|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 42||1.73|-0.50|0.2724
70966450|NCT04305275|141439202|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.658||0.8784|TWO_SIDED|95.0|-1.42|1.21|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 8||1.21|-1.42|0.8784
70966451|NCT04305275|141439202|SUPERIORITY||LS mean difference|0.93|STANDARD_ERROR_OF_MEAN|0.687||0.1795|TWO_SIDED|95.0|-0.44|2.3|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, Pre-dose||2.30|-0.44|0.1795
70966452|NCT04305275|141439202|SUPERIORITY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.829||0.5588|TWO_SIDED|95.0|-2.15|1.17|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, 5 Hours Post-dose||1.17|-2.15|0.5588
70966453|NCT04305275|141439202|SUPERIORITY||LS mean difference|0.54|STANDARD_ERROR_OF_MEAN|0.796||0.5036|TWO_SIDED|95.0|-1.06|2.13|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, 8 Hours Post-dose||2.13|-1.06|0.5036
70966454|NCT04305275|141439202|SUPERIORITY||LS mean difference|0.32|STANDARD_ERROR_OF_MEAN|0.736||0.6636|TWO_SIDED|95.0|-1.15|1.79|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 22||1.79|-1.15|0.6636
70966455|NCT04305275|141439202|SUPERIORITY||LS mean difference|0.64|STANDARD_ERROR_OF_MEAN|0.756||0.3999|TWO_SIDED|95.0|-0.87|2.15|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 29||2.15|-0.87|0.3999
70966456|NCT04305275|141439202|SUPERIORITY||LS mean difference|0.67|STANDARD_ERROR_OF_MEAN|0.776||0.3933|TWO_SIDED|95.0|-0.88|2.22|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 42||2.22|-0.88|0.3933
70966457|NCT04305275|141439203|SUPERIORITY||LS mean difference|-2.8|STANDARD_ERROR_OF_MEAN|1.167||0.0193|TWO_SIDED|95.0|-5.14|-0.47|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 8||-0.47|-5.14|0.0193
70966458|NCT04305275|141439203|SUPERIORITY||LS mean difference|-2.95|STANDARD_ERROR_OF_MEAN|1.277||0.0243|TWO_SIDED|95.0|-5.51|-0.4|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15||-0.40|-5.51|0.0243
70966459|NCT04305275|141439203|SUPERIORITY||LS mean difference|-2.56|STANDARD_ERROR_OF_MEAN|1.209||0.0385|TWO_SIDED|95.0|-4.98|-0.14|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 22||-0.14|-4.98|0.0385
70966460|NCT04305275|141439203|SUPERIORITY||LS mean difference|-1.37|STANDARD_ERROR_OF_MEAN|1.221||0.2682|TWO_SIDED|95.0|-3.81|1.08|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 29||1.08|-3.81|0.2682
70903893|NCT04867785|141296596|SUPERIORITY||LSMean Difference|-1.96|||<|0.001|TWO_SIDED|95.0|-2.43|-1.5|||Mixed Models Analysis|||||-1.50|-2.43|<0.001
70903894|NCT04867785|141296597|SUPERIORITY||LSMean Difference|0.98|||<|0.001|TWO_SIDED|95.0|0.52|1.43|||Mixed Models Analysis|||||1.43|0.52|<0.001
70903895|NCT04867785|141296597|SUPERIORITY||LSMean Difference|0.01||||0.935|TWO_SIDED|95.0|-0.34|0.37|||Mixed Models Analysis|||||0.37|-0.34|0.935
70903896|NCT04867785|141296597|SUPERIORITY||LSMean Difference|0.11||||0.668|TWO_SIDED|95.0|-0.39|0.6|||Mixed Models Analysis|||||0.60|-0.39|0.668
70903897|NCT04867785|141296597|SUPERIORITY||LSMean Difference|-0.58||||0.002|TWO_SIDED|95.0|-0.95|-0.21|||Mixed Models Analysis|||||-0.21|-0.95|0.002
70903898|NCT04867785|141296597|SUPERIORITY||LSMean Difference|-0.47||||0.056|TWO_SIDED|95.0|-0.95|0.01|||Mixed Models Analysis|||||0.01|-0.95|0.056
70903899|NCT04867785|141296597|SUPERIORITY||LSMean Difference|-0.61|||<|0.001|TWO_SIDED|95.0|-0.93|-0.29|||Mixed Models Analysis|||||-0.29|-0.93|<0.001
70903900|NCT04867785|141296598|SUPERIORITY||LSMean Difference|-0.24||||0.448|TWO_SIDED|95.0|-0.85|0.38|||Mixed Models Analysis|||||0.38|-0.85|0.448
70903901|NCT04867785|141296598|SUPERIORITY||LSMean Difference|-0.99||||0.001|TWO_SIDED|95.0|-1.6|-0.38|||Mixed Models Analysis|||||-0.38|-1.60|0.001
70903902|NCT04867785|141296598|SUPERIORITY||LSMean Difference|-1.2|||<|0.001|TWO_SIDED|95.0|-1.8|-0.59|||Mixed Models Analysis|||||-0.59|-1.80|<0.001
70903903|NCT04867785|141296598|SUPERIORITY||LSMean Difference|-1.83|||<|0.001|TWO_SIDED|95.0|-2.41|-1.24|||Mixed Models Analysis|||||-1.24|-2.41|<0.001
70903904|NCT04867785|141296598|SUPERIORITY||LSMean Difference|-1.63|||<|0.001|TWO_SIDED|95.0|-2.27|-0.99|||Mixed Models Analysis|||||-0.99|-2.27|<0.001
70903905|NCT04867785|141296598|SUPERIORITY||LSMean Difference|-1.85|||<|0.001|TWO_SIDED|95.0|-2.39|-1.31|||Mixed Models Analysis|||||-1.31|-2.39|<0.001
70903906|NCT04867785|141296598|SUPERIORITY||LSMean Difference|0.82|||<|0.001|TWO_SIDED|95.0|0.35|1.29|||Mixed Models Analysis|||||1.29|0.35|<0.001
70903907|NCT04867785|141296598|SUPERIORITY||LSMean Difference|0.06||||0.796|TWO_SIDED|95.0|-0.41|0.53|||Mixed Models Analysis|||||0.53|-0.41|0.796
70903908|NCT04867785|141296598|SUPERIORITY||LSMean Difference|-0.14||||0.548|TWO_SIDED|95.0|-0.61|0.32|||Mixed Models Analysis|||||0.32|-0.61|0.548
70903909|NCT04867785|141296598|SUPERIORITY||LSMean Difference|-0.77|||<|0.001|TWO_SIDED|95.0|-1.19|-0.36|||Mixed Models Analysis|||||-0.36|-1.19|<0.001
70903910|NCT04867785|141296598|SUPERIORITY||LSMean Difference|-0.57||||0.025|TWO_SIDED|95.0|-1.08|-0.07|||Mixed Models Analysis|||||-0.07|-1.08|0.025
70903911|NCT04867785|141296598|SUPERIORITY||LSMean Difference|-0.8|||<|0.001|TWO_SIDED|95.0|-1.16|-0.44|||Mixed Models Analysis|||||-0.44|-1.16|<0.001
70903912|NCT04867785|141296599|SUPERIORITY||Risk Difference (RD)|0.14||||0.121|TWO_SIDED|95.0|-0.04|0.32|||Regression, Logistic|||||0.32|-0.04|0.121
70903913|NCT04867785|141296599|SUPERIORITY||Risk Difference (RD)|0.36||||0.002|TWO_SIDED|95.0|0.13|0.59|||Regression, Logistic|||||0.59|0.13|0.002
70903914|NCT04867785|141296599|SUPERIORITY||Risk Difference (RD)|0.48|||<|0.001|TWO_SIDED|95.0|0.28|0.68|||Regression, Logistic|||||0.68|0.28|<0.001
70903915|NCT04867785|141296599|SUPERIORITY||Risk Difference (RD)|0.7|||<|0.001|TWO_SIDED|95.0|0.53|0.87|||Regression, Logistic|||||0.87|0.53|<0.001
70903916|NCT04867785|141296599|SUPERIORITY||Risk Difference (RD)|0.6|||<|0.001|TWO_SIDED|95.0|0.39|0.82|||Regression, Logistic|||||0.82|0.39|<0.001
70903917|NCT04867785|141296599|SUPERIORITY||Risk Difference (RD)|0.68|||<|0.001|TWO_SIDED|95.0|0.51|0.85|||Regression, Logistic|||||0.85|0.51|<0.001
70903918|NCT04867785|141296599|SUPERIORITY||Risk Difference (RD)|-0.21||||0.03|TWO_SIDED|95.0|-0.39|-0.02|||Regression, Logistic|||||-0.02|-0.39|0.030
70903919|NCT04867785|141296599|SUPERIORITY||Risk Difference (RD)|0.01||||0.938|TWO_SIDED|95.0|-0.22|0.24|||Regression, Logistic|||||0.24|-0.22|0.938
70903920|NCT04867785|141296599|SUPERIORITY||Risk Difference (RD)|0.13||||0.209|TWO_SIDED|95.0|-0.07|0.33|||Regression, Logistic|||||0.33|-0.07|0.209
70903921|NCT04867785|141296599|SUPERIORITY||Risk Difference (RD)|0.35|||<|0.001|TWO_SIDED|95.0|0.18|0.53|||Regression, Logistic|||||0.53|0.18|<0.001
70903922|NCT04867785|141296599|SUPERIORITY||Risk Difference (RD)|0.26||||0.024|TWO_SIDED|95.0|0.03|0.48|||Regression, Logistic|||||0.48|0.03|0.024
70903923|NCT04867785|141296599|SUPERIORITY||Risk Difference (RD)|0.33|||<|0.001|TWO_SIDED|95.0|0.16|0.51|||Regression, Logistic|||||0.51|0.16|<0.001
70903924|NCT04867785|141296600|SUPERIORITY||Risk Difference (RD)|0.14||||0.169|TWO_SIDED|95.0|-0.06|0.35|||Regression, Logistic|||||0.35|-0.06|0.169
70903925|NCT04867785|141296600|SUPERIORITY||Risk Difference (RD)|0.39||||0.001|TWO_SIDED|95.0|0.15|0.63|||Regression, Logistic|||||0.63|0.15|0.001
70903926|NCT04867785|141296600|SUPERIORITY||Risk Difference (RD)|0.37||||0.002|TWO_SIDED|95.0|0.14|0.6|||Regression, Logistic|||||0.60|0.14|0.002
70903927|NCT04867785|141296600|SUPERIORITY||Risk Difference (RD)|0.59|||<|0.001|TWO_SIDED|95.0|0.39|0.79|||Regression, Logistic|||||0.79|0.39|<0.001
70903928|NCT04867785|141296600|SUPERIORITY||Risk Difference (RD)|0.56|||<|0.001|TWO_SIDED|95.0|0.34|0.78|||Regression, Logistic|||||0.78|0.34|<0.001
70903929|NCT04867785|141296600|SUPERIORITY||Risk Difference (RD)|0.57|||<|0.001|TWO_SIDED|95.0|0.38|0.76|||Regression, Logistic|||||0.76|0.38|<0.001
70903930|NCT04867785|141296600|SUPERIORITY||Risk Difference (RD)|-0.23||||0.029|TWO_SIDED|95.0|-0.44|-0.02|||Regression, Logistic|||||-0.02|-0.44|0.029
70903931|NCT04867785|141296600|SUPERIORITY||Risk Difference (RD)|0.02||||0.898|TWO_SIDED|95.0|-0.22|0.25|||Regression, Logistic|||||0.25|-0.22|0.898
70903932|NCT04867785|141296600|SUPERIORITY||Risk Difference (RD)|0.0||||0.968|TWO_SIDED|95.0|-0.24|0.23|||Regression, Logistic|||||0.23|-0.24|0.968
70903933|NCT04867785|141296600|SUPERIORITY||Risk Difference (RD)|0.22||||0.033|TWO_SIDED|95.0|0.02|0.42|||Regression, Logistic|||||0.42|0.02|0.033
70903934|NCT04867785|141296600|SUPERIORITY||Risk Difference (RD)|0.19||||0.099|TWO_SIDED|95.0|-0.04|0.41|||Regression, Logistic|||||0.41|-0.04|0.099
70903935|NCT04867785|141296600|SUPERIORITY||Risk Difference (RD)|0.2||||0.044|TWO_SIDED|95.0|0.01|0.39|||Regression, Logistic|||||0.39|0.01|0.044
70903936|NCT04867785|141296601|SUPERIORITY||LSMean Difference|-2.12||||0.823|TWO_SIDED|95.0|-20.73|16.48|||Mixed Models Analysis|||||16.48|-20.73|0.823
70903937|NCT04867785|141296601|SUPERIORITY||LSMean Difference|-19.6||||0.165|TWO_SIDED|95.0|-47.29|8.1|||Mixed Models Analysis|||||8.10|-47.29|0.165
70903938|NCT04867785|141296601|SUPERIORITY||LSMean Difference|-33.3||||0.001|TWO_SIDED|95.0|-53.56|-13.04|||Mixed Models Analysis|||||-13.04|-53.56|0.001
70903939|NCT04867785|141296601|SUPERIORITY||LSMean Difference|-55.5|||<|0.001|TWO_SIDED|95.0|-69.77|-41.22|||Mixed Models Analysis|||||-41.22|-69.77|<0.001
70903940|NCT04867785|141296601|SUPERIORITY||LSMean Difference|-29.22||||0.015|TWO_SIDED|95.0|-52.84|-5.59|||Mixed Models Analysis|||||-5.59|-52.84|0.015
70903941|NCT04867785|141296601|SUPERIORITY||LSMean Difference|-54.61|||<|0.001|TWO_SIDED|95.0|-69.63|-39.59|||Mixed Models Analysis|||||-39.59|-69.63|<0.001
70903942|NCT04867785|141296601|SUPERIORITY||LSMean Difference|33.54|||<|0.001|TWO_SIDED|95.0|18.26|48.82|||Mixed Models Analysis|||||48.82|18.26|<0.001
70903943|NCT04867785|141296601|SUPERIORITY||LSMean Difference|16.07||||0.231|TWO_SIDED|95.0|-10.25|42.39|||Mixed Models Analysis|||||42.39|-10.25|0.231
70903944|NCT04867785|141296601|SUPERIORITY||LSMean Difference|2.37||||0.804|TWO_SIDED|95.0|-16.28|21.01|||Mixed Models Analysis|||||21.01|-16.28|0.804
70903945|NCT04867785|141296601|SUPERIORITY||LSMean Difference|-19.83|||<|0.001|TWO_SIDED|95.0|-31.01|-8.65|||Mixed Models Analysis|||||-8.65|-31.01|<0.001
70903946|NCT04867785|141296601|SUPERIORITY||LSMean Difference|6.45||||0.586|TWO_SIDED|95.0|-16.75|29.65|||Mixed Models Analysis|||||29.65|-16.75|0.586
70903947|NCT04867785|141296601|SUPERIORITY||LSMean Difference|-18.94||||0.002|TWO_SIDED|95.0|-30.93|-6.96|||Mixed Models Analysis|||||-6.96|-30.93|0.002
70903948|NCT04867785|141296602|SUPERIORITY||LSMean Difference|-0.25||||0.984|TWO_SIDED|95.0|-24.57|24.07|||Mixed Models Analysis|||||24.07|-24.57|0.984
70903949|NCT04867785|141296602|SUPERIORITY||LSMean Difference|-4.2||||0.804|TWO_SIDED|95.0|-37.44|29.03|||Mixed Models Analysis|||||29.03|-37.44|0.804
70903950|NCT04867785|141296602|SUPERIORITY||LSMean Difference|-21.47||||0.167|TWO_SIDED|95.0|-51.91|8.98|||Mixed Models Analysis|||||8.98|-51.91|0.167
70903951|NCT04867785|141296602|SUPERIORITY||LSMean Difference|-51.84|||<|0.001|TWO_SIDED|95.0|-76.09|-27.59|||Mixed Models Analysis|||||-27.59|-76.09|<0.001
70903952|NCT04867785|141296602|SUPERIORITY||LSMean Difference|-23.94||||0.168|TWO_SIDED|95.0|-57.94|10.06|||Mixed Models Analysis|||||10.06|-57.94|0.168
70903953|NCT04867785|141296602|SUPERIORITY||LSMean Difference|-50.58|||<|0.001|TWO_SIDED|95.0|-74.94|-26.22|||Mixed Models Analysis|||||-26.22|-74.94|<0.001
70903954|NCT04867785|141296602|SUPERIORITY||LSMean Difference|10.02||||0.362|TWO_SIDED|95.0|-11.55|31.6|||Mixed Models Analysis|||||31.60|-11.55|0.362
70903955|NCT04867785|141296602|SUPERIORITY||LSMean Difference|6.07||||0.696|TWO_SIDED|95.0|-24.34|36.48|||Mixed Models Analysis|||||36.48|-24.34|0.696
70903956|NCT04867785|141296602|SUPERIORITY||LSMean Difference|-11.19||||0.436|TWO_SIDED|95.0|-39.38|16.99|||Mixed Models Analysis|||||16.99|-39.38|0.436
70903957|NCT04867785|141296602|SUPERIORITY||LSMean Difference|-41.57|||<|0.001|TWO_SIDED|95.0|-62.89|-20.25|||Mixed Models Analysis|||||-20.25|-62.89|<0.001
70903958|NCT04867785|141296602|SUPERIORITY||LSMean Difference|-13.67||||0.418|TWO_SIDED|95.0|-46.75|19.42|||Mixed Models Analysis|||||19.42|-46.75|0.418
70903959|NCT04867785|141296602|SUPERIORITY||LSMean Difference|-40.31|||<|0.001|TWO_SIDED|95.0|-60.77|-19.85|||Mixed Models Analysis|||||-19.85|-60.77|<0.001
70903960|NCT04867785|141296603|SUPERIORITY||LSMean Difference|-0.49||||0.54|TWO_SIDED|95.0|-2.07|1.08|||Mixed Models Analysis|||||1.08|-2.07|0.540
70903961|NCT04867785|141296603|SUPERIORITY||LSMean Difference|-4.41|||<|0.001|TWO_SIDED|95.0|-6.69|-2.13|||Mixed Models Analysis|||||-2.13|-6.69|<0.001
70903962|NCT04867785|141296603|SUPERIORITY||LSMean Difference|-6.78|||<|0.001|TWO_SIDED|95.0|-9.47|-4.09|||Mixed Models Analysis|||||-4.09|-9.47|<0.001
70903963|NCT04867785|141296603|SUPERIORITY||LSMean Difference|-10.13|||<|0.001|TWO_SIDED|95.0|-12.24|-8.03|||Mixed Models Analysis|||||-8.03|-12.24|<0.001
70903964|NCT04867785|141296603|SUPERIORITY||LSMean Difference|-12.06|||<|0.001|TWO_SIDED|95.0|-15.06|-9.06|||Mixed Models Analysis|||||-9.06|-15.06|<0.001
70903965|NCT04867785|141296603|SUPERIORITY||LSMean Difference|-10.99|||<|0.001|TWO_SIDED|95.0|-13.24|-8.73|||Mixed Models Analysis|||||-8.73|-13.24|<0.001
70903966|NCT04867785|141296603|SUPERIORITY||LSMean Difference|-1.19||||0.135|TWO_SIDED|95.0|-2.75|0.37|||Mixed Models Analysis|||||0.37|-2.75|0.135
70903967|NCT04867785|141296603|SUPERIORITY||LSMean Difference|-5.11|||<|0.001|TWO_SIDED|95.0|-7.36|-2.86|||Mixed Models Analysis|||||-2.86|-7.36|<0.001
70903968|NCT04867785|141296603|SUPERIORITY||LSMean Difference|-7.48|||<|0.001|TWO_SIDED|95.0|-10.19|-4.77|||Mixed Models Analysis|||||-4.77|-10.19|<0.001
70903969|NCT04867785|141296603|SUPERIORITY||LSMean Difference|-10.83|||<|0.001|TWO_SIDED|95.0|-12.89|-8.77|||Mixed Models Analysis|||||-8.77|-12.89|<0.001
70903970|NCT04867785|141296603|SUPERIORITY||LSMean Difference|-12.76|||<|0.001|TWO_SIDED|95.0|-15.74|-9.77|||Mixed Models Analysis|||||-9.77|-15.74|<0.001
70903971|NCT04867785|141296603|SUPERIORITY||LSMean Difference|-11.69|||<|0.001|TWO_SIDED|95.0|-13.9|-9.47|||Mixed Models Analysis|||||-9.47|-13.90|<0.001
70903972|NCT04867785|141296604|SUPERIORITY||LSMean Difference|-0.03||||0.979|TWO_SIDED|95.0|-2.18|2.12|||Mixed Models Analysis|||||2.12|-2.18|0.979
70903973|NCT04867785|141296604|SUPERIORITY||LSMean Difference|-4.0||||0.018|TWO_SIDED|95.0|-7.32|-0.68|||Mixed Models Analysis|||||-0.68|-7.32|0.018
70903974|NCT04867785|141296604|SUPERIORITY||LSMean Difference|-7.09|||<|0.001|TWO_SIDED|95.0|-10.46|-3.71|||Mixed Models Analysis|||||-3.71|-10.46|<0.001
70903975|NCT04867785|141296604|SUPERIORITY||LSMean Difference|-13.2|||<|0.001|TWO_SIDED|95.0|-16.74|-9.66|||Mixed Models Analysis|||||-9.66|-16.74|<0.001
70903976|NCT04867785|141296604|SUPERIORITY||LSMean Difference|-12.84|||<|0.001|TWO_SIDED|95.0|-16.5|-9.18|||Mixed Models Analysis|||||-9.18|-16.50|<0.001
70903977|NCT04867785|141296604|SUPERIORITY||LSMean Difference|-13.91|||<|0.001|TWO_SIDED|95.0|-17.1|-10.71|||Mixed Models Analysis|||||-10.71|-17.10|<0.001
70903978|NCT04867785|141296604|SUPERIORITY||LSMean Difference|-1.34||||0.213|TWO_SIDED|95.0|-3.45|0.77|||Mixed Models Analysis|||||0.77|-3.45|0.213
70903979|NCT04867785|141296604|SUPERIORITY||LSMean Difference|-5.31||||0.002|TWO_SIDED|95.0|-8.66|-1.97|||Mixed Models Analysis|||||-1.97|-8.66|0.002
70903980|NCT04867785|141296604|SUPERIORITY||LSMean Difference|-8.4|||<|0.001|TWO_SIDED|95.0|-11.76|-5.04|||Mixed Models Analysis|||||-5.04|-11.76|<0.001
70903981|NCT04867785|141296604|SUPERIORITY||LSMean Difference|-14.51|||<|0.001|TWO_SIDED|95.0|-18.0|-11.01|||Mixed Models Analysis|||||-11.01|-18.00|<0.001
70903982|NCT04867785|141296604|SUPERIORITY||LSMean Difference|-14.15|||<|0.001|TWO_SIDED|95.0|-17.77|-10.54|||Mixed Models Analysis|||||-10.54|-17.77|<0.001
70903983|NCT04867785|141296604|SUPERIORITY||LSMean Difference|-15.22|||<|0.001|TWO_SIDED|95.0|-18.36|-12.07|||Mixed Models Analysis|||||-12.07|-18.36|<0.001
70903984|NCT03926065|141296613|SUPERIORITY|||||||0.126|||||||Mixed Models Analysis|||Standard Palatability (Standard Portion Size and Larger Portion Size) compared to Enhanced Palatability (Standard Portion Size and Larger Portion Size)||||0.1260
70903985|NCT03926065|141296613|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Standard Portion Size (Standard Palatability and Enhanced Palatability) compared to Larger Portion Size (Standard Palatability and Enhanced Palatability)||||<0.0001
70903986|NCT03926065|141296613|SUPERIORITY|||||||0.0992|||||||Mixed Models Analysis|||Interaction between Portion Size and Palatability||||0.0992
70903987|NCT03926065|141296614|SUPERIORITY|||||||0.5502|||||||Mixed Models Analysis|||Standard Palatability (Standard Portion Size and Larger Portion Size) compared to Enhanced Palatability (Standard Portion Size and Larger Portion Size)||||0.5502
70903988|NCT03926065|141296614|SUPERIORITY|||||||0.0072|||||||Mixed Models Analysis|||Standard Portion Size (Standard Palatability and Enhanced Palatability) compared to Larger Portion Size (Standard Palatability and Enhanced Palatability)||||0.0072
70903989|NCT03926065|141296615|SUPERIORITY|||||||0.103|||||||Mixed Models Analysis|||Standard Palatability (Standard Portion Size and Larger Portion Size) compared to Enhanced Palatability (Standard Portion Size and Larger Portion Size)||||0.1030
70903990|NCT03926065|141296615|SUPERIORITY|||||||0.0178|||||||Mixed Models Analysis|||Standard Portion Size (Standard Palatability and Enhanced Palatability) compared to Larger Portion Size (Standard Palatability and Enhanced Palatability)||||0.0178
70903991|NCT03926065|141296615|SUPERIORITY|||||||0.241|||||||Mixed Models Analysis|||Interaction between Portion Size and Palatability||||0.2410
70903992|NCT03926065|141296616|SUPERIORITY|||||||0.0012|||||||Mixed Models Analysis|||Standard Palatability (Standard Portion Size and Larger Portion Size) compared to Enhanced Palatability (Standard Portion Size and Larger Portion Size)||||0.0012
70903993|NCT03926065|141296616|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Standard Portion Size (Standard Palatability and Enhanced Palatability) compared to Larger Portion Size (Standard Palatability and Enhanced Palatability)||||<0.0001
70903994|NCT03239873|141296620|NON_INFERIORITY|The conclusion of non-inferiority (similarity) is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease equal to or more than the prespecified criterion of 10.0 percentage points for Varicella zoster virus.|Risk Difference (RD)|0.0|||<|0.001|TWO_SIDED|95.0|-2.7|2.8|||Miettinen and Nurminen|||||2.8|-2.7|<0.001
70903995|NCT03239873|141296620|OTHER|Acceptability|Antibody Response Rate|98.4|||<|0.001|TWO_SIDED|95.0|95.9|99.6|||Exact CI method/binomial proportion|||The conclusion of acceptability is based on the lower bound of the 95% Confidence Interval (CI) being \>76%, and implies that the value of the parameter is statistically significantly greater than the prespecified acceptability criterion (76%).||99.6|95.9|<0.001
70903996|NCT03239873|141296621|NON_INFERIORITY|The statistical criterion for noninferiority of the GMT corresponds to the lower bound of the 2-sided 95% CI on the GMT ratio \[VARIVAX® PE34 process/VARIVAX® 2016 commercial product\] being \>0.67.|Risk Difference (RD)|1.0|||<|0.001|TWO_SIDED|95.0|0.9|1.1|||Miettinen and Nurminen|||||1.1|0.9|<0.001
70903997|NCT03239873|141296622|OTHER||Difference in Percentage|2.0||||0.436|TWO_SIDED|95.0|-3.1|7.1|||Miettinen & Nurminen|||Up to 42 days after Vaccination 1||7.1|-3.1|0.436
70903998|NCT03239873|141296622|OTHER||Difference in Percentage|2.9||||0.204|TWO_SIDED|95.0|-1.6|7.5|||Miettinen & Nurminen|||Up to 42 days after Vaccination 2||7.5|-1.6|0.204
70903999|NCT03239873|141296623|OTHER||Difference in Percentage|-1.3||||0.102|TWO_SIDED|95.0|-3.5|0.4|||Miettinen & Nurminen|||Measles-like rash||0.4|-3.5|0.102
70904000|NCT03239873|141296623|OTHER||Difference in Percentage|0.3||||0.317|TWO_SIDED|95.0|-0.9|1.9|||Miettinen & Nurminen|||Rubella-like rash||1.9|-0.9|0.317
70904001|NCT03239873|141296623|OTHER||Difference in Percentage|1.3||||0.241||95.0|-1.0|4.0|||Miettinen & Nurminen|||Varicella-like rash||4.0|-1.0|0.241
70904002|NCT03239873|141296623|OTHER||Difference in Percentage|-0.3||||0.318|TWO_SIDED|95.0|-1.9|0.9|||Miettinen & Nurminen|||Zoster-like rash||0.9|-1.9|0.318
70904003|NCT03239873|141296624|OTHER||Difference in Percentage|1.1||||0.17|TWO_SIDED|95.0|-0.7|3.4|||Miettinen & Nurminen|||Measles-like rash||3.4|-0.7|0.170
70904004|NCT03239873|141296624|OTHER||Difference in Percentage|-0.3||||0.576|TWO_SIDED|95.0|-2.2|1.4|||Miettinen & Nurminen|||Varicella-like rash||1.4|-2.2|0.576
70904005|NCT03239873|141296624|OTHER||Difference in Percentage|0.4||||0.312|TWO_SIDED|95.0|-1.0|2.0|||Miettinen & Nurminen|||Zoster-like rash||2.0|-1.0|0.312
70904006|NCT03239873|141296625|OTHER||Difference of Percentage|-1.0||||0.696|TWO_SIDED|95.0|-5.9|4.0|||Miettinen & Nurminen|||Injection site erythema||4.0|-5.9|0.696
70904007|NCT03239873|141296625|OTHER||Difference in Percentage|0.7||||0.796|TWO_SIDED|95.0|-4.7|6.2|||Miettinen & Nurminen|||Injection site pain||6.2|-4.7|0.796
70904008|NCT03239873|141296625|OTHER||Difference in Percentage|-2.7||||0.111||95.0|-6.2|0.7|||Miettinen & Nurminen|||Injection site swelling||0.7|-6.2|0.111
70904009|NCT03239873|141296626|OTHER||Difference in Percentage|-0.3||||0.931|TWO_SIDED|95.0|-6.9|6.4|||Miettinen & Nurminen|||Injection site erythema||6.4|-6.9|0.931
70904010|NCT03239873|141296626|OTHER||Difference in Percentage|-1.6||||0.523|TWO_SIDED|95.0|-6.6|3.4|||Miettinen & Nurminen|||Injection site pain||3.4|-6.6|0.523
70904011|NCT03239873|141296626|OTHER||Difference in Percentage|2.0||||0.415|TWO_SIDED|95.0|-2.9|6.9|||Miettinen & Nurminen|||Injection site swelling||6.9|-2.9|0.415
70904012|NCT03239873|141296627|OTHER||Difference in Percentage|1.6|||||TWO_SIDED|95.0|-3.4|6.7|||||Miettinen \& Nurminen|||6.7|-3.4|
70904013|NCT03239873|141296628|OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-2.5|2.6|||||Miettinen \& Nurminen|||2.6|-2.5|
70904014|NCT03239873|141296629|OTHER||Difference in Percentage|1.9|||||TWO_SIDED|95.0|-6.1|9.8|||||Miettinen \& Nurminen|||9.8|-6.1|
70904015|NCT03239873|141296630|OTHER||Difference in Percentage|2.3|||||TWO_SIDED|95.0|-4.7|9.2|||||Miettinen \& Nurminen|||9.2|-4.7|
70904016|NCT03239873|141296635|OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-1.3|1.3|||||Miettinen \& Nurminen|||1.3|-1.3|
70904017|NCT03239873|141296636|OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-1.3|1.3|||||Miettinen \& Nurminen|||1.3|-1.3|
70904018|NCT03239873|141296639|OTHER||Difference in Percentage|2.9|||||TWO_SIDED|95.0|-4.6|10.3|||||Miettinen and Nurminen|||10.3|-4.6|
70966461|NCT04305275|141439203|SUPERIORITY||LS mean difference|1.13|STANDARD_ERROR_OF_MEAN|1.233||0.3649|TWO_SIDED|95.0|-1.34|3.59|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 42||3.59|-1.34|0.3649
70966462|NCT04305275|141439204|SUPERIORITY||LS mean difference|-1.26|STANDARD_ERROR_OF_MEAN|1.078||0.2478|TWO_SIDED|95.0|-3.41|0.9|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 8||0.90|-3.41|0.2478
70966463|NCT04305275|141439204|SUPERIORITY||LS mean difference|-0.91|STANDARD_ERROR_OF_MEAN|1.192||0.4486|TWO_SIDED|95.0|-3.29|1.47|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, Pre-dose||1.47|-3.29|0.4486
70966464|NCT04305275|141439204|SUPERIORITY||LS mean difference|-1.52|STANDARD_ERROR_OF_MEAN|1.352||0.2662|TWO_SIDED|95.0|-4.22|1.19|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, 5 Hours Post-dose||1.19|-4.22|0.2662
70966465|NCT04305275|141439204|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|1.282||0.9965|TWO_SIDED|95.0|-2.56|2.57|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, 8 Hours Post-dose||2.57|-2.56|0.9965
70966466|NCT04305275|141439204|SUPERIORITY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|1.222||0.8437|TWO_SIDED|95.0|-2.68|2.2|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 22||2.20|-2.68|0.8437
70966467|NCT04305275|141439204|SUPERIORITY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|1.232||0.796|TWO_SIDED|95.0|-2.78|2.14|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 29||2.14|-2.78|0.7960
70966468|NCT04305275|141439204|SUPERIORITY||LS mean difference|2.28|STANDARD_ERROR_OF_MEAN|1.119||0.0456|TWO_SIDED|95.0|0.05|4.52|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 42||4.52|0.05|0.0456
70966469|NCT01022242|141439207|SUPERIORITY_OR_OTHER|||||||0.8861|||||||ANCOVA|||||||0.8861
70966470|NCT00117598|141439208|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39|||<|0.0001|TWO_SIDED|95.0|0.25|0.63|||Log Rank||HR from a cox model adjusted for baseline stratification factors|Two null hypotheses (Ho) tested: 1. PFS distributions for temsirolimus 175/75 mg and investigator's choice treatment groups are identical. 2. PFS distributions for temsirolimus 175/25 mg and investigator's choice treatment groups are identical. Alternative hypothesis (Ha) for each test was that PFS distributions differed.||0.63|0.25|<0.0001
70966471|NCT00117598|141439208|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41|||<|0.0001|TWO_SIDED|95.0|0.26|0.65|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||0.65|0.26|<0.0001
70966472|NCT00117598|141439209|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||Fisher Exact|||||||0.0019
70966473|NCT00117598|141439209|SUPERIORITY_OR_OTHER|||||||0.6179|TWO_SIDED||||||Fisher Exact|||||||0.6179
70966474|NCT00117598|141439210|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.3053|TWO_SIDED|95.0|0.46|1.28|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||1.28|0.46|0.3053
70966475|NCT00117598|141439210|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.98||||0.9515|TWO_SIDED|95.0|0.6|1.62|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||1.62|0.60|0.9515
70966476|NCT00117598|141439211|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.14|9.01|||||HR from a cox model adjusted for baseline stratification factors|||9.01|0.14|
70966477|NCT00117598|141439211|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.1|13.3|||||HR from a cox model adjusted for baseline stratification factors|||13.3|0.10|
70966478|NCT00117598|141439213|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36|||<|0.0001|TWO_SIDED|95.0|0.23|0.56|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||0.56|0.23|<0.0001
70966479|NCT00117598|141439213|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39|||<|0.0001|TWO_SIDED|95.0|0.26|0.6|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||0.60|0.26|<0.0001
70966480|NCT00117598|141439214|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39||||0.0004|TWO_SIDED|95.0|0.23|0.67|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||0.67|0.23|0.0004
70966481|NCT00117598|141439214|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.0712|TWO_SIDED|95.0|0.4|1.04|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||1.04|0.40|0.0712
70966482|NCT04688775|141439221|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.5048|TWO_SIDED|95.0|-1.3|2.6|||Mixed Models Repeated Measures|||Change From Baseline in the Number of Weekly Attacks: Eptinezumab vs. Placebo||2.6|-1.3|0.5048
70966483|NCT04688775|141439226|SUPERIORITY||Hazard Ratio (HR)|1.45||||0.0772|TWO_SIDED|95.0|0.96|2.17|||Regression, Cox|||||2.17|0.96|0.0772
70966484|NCT04261504|141439266|SUPERIORITY|||||||0.03||||||Threshold p\<0.05.|threshold-free cluster enhancement|||||||0.03
70966485|NCT00382018|141439274|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.69|1.47|||Log Rank|||Hazard Ration of overall survival compared Arm C2 to Arm C1.||1.47|0.69|0.98
70966486|NCT00382018|141439275|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.64|TWO_SIDED|95.0|0.64|1.32|||Log Rank|||Hazard Ratio of progression free survival compared Arm C2 to Arm C1||1.32|0.64|0.64
70966487|NCT00493220|141439280|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (natural log-transformed)|111.79|||||TWO_SIDED|90.0|108.57|115.12|||Schuirmann two one-sided tests procedure||HYLENEX SC/Placebo SC|||115.12|108.57|
70966488|NCT00493220|141439280|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (natural log-transformed)|60.81|||||TWO_SIDED|90.0|59.06|62.62|||Schuirmann two one-sided tests procedure||HYLENEX SC/Intravenous|||62.62|59.06|
70966489|NCT00493220|141439280|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|54.4|||||TWO_SIDED|90.0|52.82|56.01|||Schuirmann two one-sided tests procedure||Placebo SC/Intravenous|||56.01|52.82|
70966490|NCT00493220|141439281|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.0|||<|0.01|TWO_SIDED|90.0|-1.25|-0.75|||Wilcoxon signed-rank test||HYLENEX SC minus Placebo SC|||-0.75|-1.25|<0.01
70966491|NCT00493220|141439281|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.52|||<|0.01|TWO_SIDED|90.0|1.27|1.71|||Wilcoxon signed-rank test||Placebo SC minus Intravenous|||1.71|1.27|<0.01
70966492|NCT00493220|141439281|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.52|||<|0.01|TWO_SIDED|90.0|2.26|2.76|||Wilcoxon signed-rank test||Placebo SC minus Intravenous|||2.76|2.26|<0.01
70966493|NCT00493220|141439282|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|101.99|||||TWO_SIDED|90.0|98.95|105.12|||Schuirmann two one-sided tests procedure||HYLENEX SC/Placebo SC|||105.12|98.95|
70966494|NCT00493220|141439282|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|106.79|||||TWO_SIDED|90.0|103.61|110.07|||Schuirmann two one-sided tests procedure||HYLENEX SC/Intravenous|||110.07|103.61|
70966495|NCT00493220|141439282|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|104.71|||||TWO_SIDED|90.0|101.59|107.92|||Schuirmann two one-sided tests procedure||Placebo SC/Intravenous|||107.92|101.59|
70966496|NCT00493220|141439283|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 95% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|101.76|||||TWO_SIDED|90.0|98.64|104.98|||Schuirmann two one-sided tests procedure||HYLENEX SC/Placebo SC|||104.98|98.64|
70966497|NCT00493220|141439283|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|106.95|||||TWO_SIDED|90.0|103.67|110.33|||Schuirmann two one-sided tests procedure||HYLENEX SC/Intravenous|||110.33|103.67|
70966498|NCT00493220|141439283|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|105.1|||||TWO_SIDED|90.0|101.87|108.42|||Schuirmann two one-sided tests procedure||Placebo SC/Intravenous|||108.42|101.87|
70966499|NCT01357577|141439307|OTHER|||||||0.48||||||P-Value show above is for post-assessment time point.|Mixed Models Analysis|Mixed-model p-values are adjusted for study site and the baseline total CAPS score.||||||.48
70966500|NCT01357577|141439307|OTHER|||||||0.12||||||The p-value shown above is for the 6-month time point.|Mixed Models Analysis|Mixed-model p-values are adjusted for study site and the baseline total CAPS score.||||||.12
70966501|NCT01357577|141439307|OTHER|||||||0.65||||||The p-value shown above refers to the treatment main effect.|Mixed Models Analysis|||||||.65
70966502|NCT01357577|141439307|OTHER|||||||0.072||||||The p-value shown above refers to the timepoint main effect.|Mixed Models Analysis|||||||.072
70966503|NCT01357577|141439307|OTHER|||||||0.005|||||||Mixed Models Analysis|The p-value shown above refers to the interaction.||||||.0050
70966504|NCT01357577|141439307|OTHER|||||||0.12|||||||Mixed Models Analysis|The p-value shown above refers to the site main effect.||||||.12
70966505|NCT01357577|141439308|OTHER|mixed-effects linear regression model adjusted for study site and the baseline value of the dependent variable.||||||0.12||||||Post-treatment P-value.|Mixed Models Analysis|Mixed-model p-values are adjusted for study site and baseline ASI (Alcohol Use) score.||||||.12
70966506|NCT01357577|141439308|OTHER|||||||0.84||||||6-month P-Value.|Mixed Models Analysis|Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score.||||||.84
70966507|NCT01357577|141439308|OTHER|||||||0.26||||||treatment main effect|Mixed Models Analysis|Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score.||||||.26
70966508|NCT01357577|141439308|OTHER|||||||0.14||||||Timepoint main effect P-value|Mixed Models Analysis|Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score.||||||.14
70966509|NCT01357577|141439308|OTHER|||||||0.29||||||interaction|Mixed Models Analysis|Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score.||||||.29
70966510|NCT01357577|141439308|OTHER|||||||0.16||||||Site main effect P-Value.|Mixed Models Analysis|Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score.||||||.16
70966511|NCT01357577|141439309|OTHER|||||||0.66||||||Post-treatment p-value.|Mixed Models Analysis|Mixed-model p-values are adjusted for study site and baseline ASI (drug score).||||||.66
70966512|NCT01357577|141439309|OTHER|||||||0.53||||||6-month P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score.||||||.53
70966513|NCT01357577|141439309|OTHER|||||||0.86||||||Treatment main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score.||||||.86
70966514|NCT01357577|141439309|OTHER|||||||0.16||||||Timepoint main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score.||||||.16
70966515|NCT01357577|141439309|OTHER|||||||0.47||||||Interaction P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score.||||||.47
70966516|NCT01357577|141439309|OTHER|||||||0.19||||||Site main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score.||||||.19
70966517|NCT01357577|141439310|OTHER|||||||0.18||||||Post-Treatment P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.||||||.18
70966518|NCT01357577|141439310|OTHER|||||||0.45||||||P-value at 6 months.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.||||||.45
70966519|NCT01357577|141439310|OTHER|||||||0.73||||||Treatment main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.||||||.73
70966520|NCT01357577|141439310|OTHER|||||||0.63||||||Timepoint main effect P-Value|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.||||||.63
70966521|NCT01357577|141439310|OTHER|||||||0.024||||||Interaction P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.||||||.024
70966522|NCT01357577|141439310|OTHER|||||||0.15||||||Site main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.||||||.15
70966523|NCT01357577|141439311|OTHER|||||||0.48||||||Post-Treatment P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.||||||.48
70966524|NCT01357577|141439311|OTHER|||||||0.2||||||6-Month P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.||||||.20
70966525|NCT01357577|141439311|OTHER|||||||0.26||||||Treatment main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.||||||.26
70966526|NCT01357577|141439311|OTHER|||||||0.71||||||Timepoint main effect.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.||||||.71
70966527|NCT01357577|141439311|OTHER|||||||0.56||||||Interaction main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.||||||.56
70966528|NCT01357577|141439311|OTHER|||||||0.51||||||Site main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.||||||.51
70966529|NCT00938717|141439312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.65|||<|0.0001|TWO_SIDED|95.0|2.44|8.84||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week APC 3 + 1 Responders. The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data.||8.84|2.44|<0.0001
70966530|NCT00938717|141439313|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.19|||<|0.0001|TWO_SIDED|95.0|2.5|7.03||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week CSBM 3 + 1 Responders. The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data.||7.03|2.50|<0.0001
70966531|NCT00938717|141439314|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.62|||<|0.0001|TWO_SIDED|95.0|1.91|3.6||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week Abdominal Pain Responders. The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data.||3.60|1.91|<0.0001
70966532|NCT00938717|141439315|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.16|||<|0.0001|TWO_SIDED|95.0|2.22|4.49||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 6/12 Week APC + 1 Responders.~The power, adjusted for multiplicity, was expected to be 86% based on NCT00460811 (MCP-103-202) study data."||4.49|2.22|<0.0001
70966533|NCT02248259|141439340|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|113.6|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|90.0|100.522|128.376|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for BI 409306||128.376|100.522|
70966534|NCT02248259|141439340|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|87.98|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|90.0|77.839|99.452|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for BI 409306||99.452|77.839|
70966535|NCT02248259|141439340|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|89.21|STANDARD_ERROR_OF_MEAN|1.029|||TWO_SIDED|90.0|84.636|94.021|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for CD 13896||94.021|84.636|
70966536|NCT02248259|141439340|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|92.89|STANDARD_ERROR_OF_MEAN|1.026|||TWO_SIDED|90.0|88.592|97.396|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis of CD 13896||97.396|88.592|
70966537|NCT02248259|141439340|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|99.61|STANDARD_ERROR_OF_MEAN|1.022|||TWO_SIDED|90.0|95.796|103.584|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for CD 14084||103.584|95.796|
70966538|NCT02248259|141439340|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|104.37|STANDARD_ERROR_OF_MEAN|1.031|||TWO_SIDED|90.0|98.783|110.278|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for CD 14084||110.278|98.783|
70966539|NCT02248259|141439341|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|93.26|STANDARD_ERROR_OF_MEAN|1.086|||TWO_SIDED|90.0|80.377|108.217|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for BI 409306||108.217|80.377|
70966540|NCT02248259|141439341|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|76.65|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|60.482|97.141|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for BI 409306||97.141|60.482|
70966541|NCT02248259|141439341|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|78.71|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|90.0|67.304|92.052|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for CD 13896||92.052|67.304|
70966542|NCT02248259|141439341|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|95.29|STANDARD_ERROR_OF_MEAN|1.093|||TWO_SIDED|90.0|81.092|111.964|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for CD 13896||111.964|81.092|
70966543|NCT02248259|141439341|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|86.79|STANDARD_ERROR_OF_MEAN|1.041|||TWO_SIDED|90.0|80.731|93.309|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for CD 14084||93.309|80.731|
70966544|NCT02248259|141439341|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|107.45|STANDARD_ERROR_OF_MEAN|1.091|||TWO_SIDED|90.0|91.764|125.812|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for CD 14084||125.812|91.764|
70966545|NCT02248259|141439342|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|113.61|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|90.0|100.505|128.427|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for BI 409306||128.427|100.505|
70966546|NCT02248259|141439342|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|87.91|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|90.0|77.763|99.37|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for BI 409306||99.370|77.763|
70966547|NCT02248259|141439342|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|89.05|STANDARD_ERROR_OF_MEAN|1.029|||TWO_SIDED|90.0|84.478|93.859|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for CD 13896||93.859|84.478|
70966548|NCT02248259|141439342|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|92.48|STANDARD_ERROR_OF_MEAN|1.026|||TWO_SIDED|90.0|88.278|96.889|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for CD 13896||96.889|88.278|
70966549|NCT02248259|141439342|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|99.61|STANDARD_ERROR_OF_MEAN|1.022|||TWO_SIDED|90.0|95.791|103.583|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for CD 14084||103.583|95.791|
70966550|NCT02248259|141439342|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|104.44|STANDARD_ERROR_OF_MEAN|1.031|||TWO_SIDED|90.0|98.861|110.336|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for CD 14084||110.336|98.861|
70966551|NCT01206062|141439347|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75|||<|0.001|TWO_SIDED|95.0|0.64|0.89|||Regression, Cox|||||0.89|0.64|<0.001
70966552|NCT01206062|141439348|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.003|TWO_SIDED|95.0|0.6|0.9|||Regression, Cox|||||0.90|0.60|0.003
70966553|NCT01206062|141439349|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79||||0.58|TWO_SIDED|95.0|0.34|1.83|||Regression, Cox|||||1.83|0.34|0.58
70966554|NCT01206062|141439351|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.83||||0.1|TWO_SIDED|95.0|0.67|1.04|||Regression, Cox|||||1.04|0.67|.10
70966555|NCT01825057|141439433|SUPERIORITY||Mean Difference (Final Values)|17.5||||0.0009|TWO_SIDED|||||adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner Method|Kruskal-Wallis|degrees of freedom = 2|mean difference = Order One - Do One|||||0.0009
70966556|NCT01825057|141439433|SUPERIORITY||Median Difference (Final Values)|19.7|||<|0.0001|TWO_SIDED|||||Adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner Method|Kruskal-Wallis|degrees of freedom = 2|mean difference = Order One - See One|||||<0.0001
70966557|NCT01825057|141439433|SUPERIORITY||Mean Difference (Final Values)|2.178||||0.4983|TWO_SIDED||||||Kruskal-Wallis|degrees of freedom = 2|mean difference = Do One - See One|||||0.4983
70966558|NCT01825057|141439434|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.0217|TWO_SIDED|||||Adjusted for multiple comparisons using the Dwass, Steel, Critchlow-Fligner Method.|Kruskal-Wallis||Mean difference = Order One - Do One|||||0.0217
70966559|NCT01825057|141439434|SUPERIORITY|mean difference is Order One - See One|Mean Difference (Final Values)|1.22||||0.0126|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis|||||||0.0126
70966560|NCT01825057|141439434|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.4231|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||mean difference is Do One - See One|||||0.4231
70966561|NCT01825057|141439435|SUPERIORITY||Mean Difference (Final Values)|0.44||||0.0091|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||Mean difference = Order One - Do One|||||0.0091
70966562|NCT01825057|141439435|SUPERIORITY||Mean Difference (Final Values)|1.04||||0.0196|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||mean difference = Order One - See One|||||0.0196
70966563|NCT01825057|141439435|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.2832|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||mean difference = Do One - See One|||||0.2832
70966564|NCT01825057|141439436|SUPERIORITY||Mean Difference (Final Values)|0.43||||0.1566|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||Mean difference = Order One - Do One|||||0.1566
70966565|NCT01825057|141439436|SUPERIORITY||Mean Difference (Final Values)|0.88||||0.0982|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||mean difference = Order One - See One|||||0.0982
70966566|NCT01825057|141439436|SUPERIORITY||Mean Difference (Final Values)|0.45||||0.6631|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||mean difference = Do One - See One|||||0.6631
70966567|NCT01825057|141439437|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.1327|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||Mean difference = Order One - Do One|||||.1327
70966568|NCT01825057|141439437|SUPERIORITY||Mean Difference (Final Values)|0.57||||0.4097|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||||mean difference = Order One - See One|||0.4097
70966569|NCT01825057|141439437|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.8779|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||mean difference = Do One - See One|||||0.8779
70966570|NCT04746833|141439448|EQUIVALENCE|mean of Summit will be equal to mean of control||||||0.91|||||||t-test, 2 sided|||||||.91
70966571|NCT04746833|141439449|OTHER|||||||||||||||||descriptive statistic of system use|simple descriptive findings for evaluation of feasibility of the Sumit app|||
70966572|NCT04746833|141439450|EQUIVALENCE|standard null hypothesis of no difference between groups||||||0.5|||||||t-test, 2 sided|||||||.50
70966573|NCT02015442|141439455|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||Baseline vs. treatment period||||0.390
70966574|NCT02015442|141439455|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||Baseline vs treatment||||0.204
70966575|NCT02015442|141439456|SUPERIORITY|||||||0.001||||||calculated|t-test, 2 sided|||Baseline vs treatment||||0.001
70966576|NCT02015442|141439456|SUPERIORITY|||||||0.244|||||||t-test, 2 sided|||Baseline vs treatment||||0.244
70966577|NCT02015442|141439456|SUPERIORITY|||||||0.244|||||||ANOVA|||||||0.244
70966578|NCT00290290|141439457|SUPERIORITY_OR_OTHER||Relative Risk|0.59||||0.004|TWO_SIDED|95.0|0.41|0.85|||Log Rank|||The average baseline rate of surgical-site infection at the six participating hospitals was 14% after clean-contaminated surgery with povidone-iodine skin preparation, and we estimated that substituting chlorhexidine-alcohol for povidone-iodine would reduce this rate to 7%. Therefore, we planned to enroll approximately 430 patients in each study group who could be evaluated in order for the study to have 90% power to detect a significant difference in the rates of surgical-site infection.||0.85|0.41|0.004
70966579|NCT04013789|141439460|NON_INFERIORITY|The noninferiority margin was set at 0.05.|Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.006|||ONE_SIDED|95.0||0.03|||Mixed Effects Repeated Measures Model||DACP FreshTech minus DACP|||0.03||
70966580|NCT00549939|141439462|SUPERIORITY_OR_OTHER|||||||1||||||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||1.00
70904019|NCT02670538|141296643|SUPERIORITY||Least Squares (LS) Mean Difference|-2.5||||0.0417|TWO_SIDED|95.0|-4.6|-0.4||Adjusted p-value: adjustment was performed using matched parallel gatekeeping procedure to control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6.|Contrast t-test|||||-0.4|-4.6|0.0417
70904020|NCT02670538|141296643|SUPERIORITY||LS Mean Difference|-1.8||||0.1051|TWO_SIDED|95.0|-3.9|0.4||Adjusted p-value: adjustment was performed using matched parallel gatekeeping procedure to control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6.|Contrast t-test|||||0.4|-3.9|0.1051
70904021|NCT02670538|141296644|SUPERIORITY||LS Mean Difference|-0.3||||0.0417|TWO_SIDED|95.0|-0.6|-0.1||Adjusted p-value: adjustment was performed using matched parallel gatekeeping procedure to control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6.|Contrast t-test|||||-0.1|-0.6|0.0417
70904022|NCT02670538|141296644|SUPERIORITY||LS Mean Difference|-0.2||||0.137|TWO_SIDED|95.0|-0.4|0.1||Adjusted p-value: adjustment was performed using matched parallel gatekeeping procedure to control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6.|Contrast t-test|||||0.1|-0.4|0.1370
70904023|NCT01077362|141296679|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
70904024|NCT01077362|141296679|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
70904025|NCT01077362|141296679|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
70904026|NCT01077362|141296680|SUPERIORITY_OR_OTHER|||||||0.002|||||||re-randomization test|||||||0.002
70904027|NCT01077362|141296680|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
70904028|NCT01077362|141296680|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
70904029|NCT01077362|141296681|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
70904030|NCT01077362|141296681|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
70904031|NCT01077362|141296681|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
70904032|NCT01077362|141296682|SUPERIORITY_OR_OTHER|||||||0.018|||||||re-randomization test|||||||0.018
70904033|NCT01077362|141296682|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
70904034|NCT01077362|141296682|SUPERIORITY_OR_OTHER|||||||0.002|||||||re-randomization test|||||||0.002
70904035|NCT01077362|141296683|SUPERIORITY_OR_OTHER|||||||0.017|||||||re-randomization test|||||||0.017
70904036|NCT01077362|141296683|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
70904037|NCT01077362|141296683|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
70904038|NCT01077362|141296684|SUPERIORITY_OR_OTHER|||||||0.171|||||||re-randomization|||||||0.171
70904039|NCT01077362|141296684|SUPERIORITY_OR_OTHER|||||||0.06|||||||re-randomization test|||||||0.060
70904040|NCT01077362|141296684|SUPERIORITY_OR_OTHER|||||||0.094|||||||re-randomization|||||||0.094
70904041|NCT01872910|141296685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.0|||||TWO_SIDED|95.0|-2.1|20.0|||||95% CrI is reported here, not the CI.|||20.0|-2.1|
70904042|NCT01872910|141296685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-34.6|||||TWO_SIDED|95.0|-45.7|-23.2|||||95% CrI is reported here, not the CI.|||-23.2|-45.7|
70904043|NCT01872910|141296685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|43.6|||||TWO_SIDED|95.0|32.7|54.9|||||95% CrI is reported here, not the CI.|||54.9|32.7|
70904044|NCT01872910|141296686|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-2.9|0.2|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 4 h.|||0.2|-2.9|
70904045|NCT01872910|141296686|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.5|||||TWO_SIDED|95.0|2.9|6.0|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 4 h.|||6.0|2.9|
70904046|NCT01872910|141296686|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.9|||||TWO_SIDED|95.0|-7.4|-4.3|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 4 h.|||-4.3|-7.4|
70904047|NCT01872910|141296686|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-5.2|0.2|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 6 h.|||0.2|-5.2|
70904048|NCT01872910|141296686|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.1|||||TWO_SIDED|95.0|4.4|9.8|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 6 h.|||9.8|4.4|
70904049|NCT01872910|141296686|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.6|||||TWO_SIDED|95.0|-12.2|-6.9|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 6 h.|||-6.9|-12.2|
70904050|NCT01872910|141296686|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.0|||||TWO_SIDED|95.0|-7.9|-0.1|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 8 h.|||-0.1|-7.9|
70904051|NCT01872910|141296686|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.2|||||TWO_SIDED|95.0|5.3|13.0|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 8 h.|||13.0|5.3|
70904052|NCT01872910|141296686|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.1|||||TWO_SIDED|95.0|-16.9|-9.3|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 8 h.|||-9.3|-16.9|
70904053|NCT01872910|141296686|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.8|||||TWO_SIDED|95.0|-13.2|0.5|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 12 h.|||0.5|-13.2|
70904054|NCT01872910|141296686|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.9|||||TWO_SIDED|95.0|6.6|19.2|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 12 h.|||19.2|6.6|
70904055|NCT01872910|141296686|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.7|||||TWO_SIDED|95.0|-25.9|-13.5|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 12 h.|||-13.5|-25.9|
70904056|NCT01872910|141296686|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.3|||||TWO_SIDED|95.0|-30.8|-2.0|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 24 h.|||-2.0|-30.8|
70904057|NCT01872910|141296686|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|23.1|||||TWO_SIDED|95.0|9.0|37.2|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 24 h.|||37.2|9.0|
70966581|NCT00549939|141439462|SUPERIORITY_OR_OTHER|||||||0.91||||||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.91
70966582|NCT00549939|141439464|SUPERIORITY_OR_OTHER||LS Mean difference versus Placebo|-6.2|STANDARD_ERROR_OF_MEAN|3.8||0.104|TWO_SIDED|95.0|-13.72|1.29||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA|||"Change in detrusor LPP was analyzed using a three-way analysis of covariance (ANCOVA) including 3 variables as fixed effects:~* treatment group (alfuzosin 0.1 mg/kg/day, alfuzosin 0.2 mg/kg/day or placebo),~* age/formulation group (2-7 years of age on solution, 8-16 years of age on solution or 8-16 years of age on tablets),~* anticholinergic/antimuscarinic use (yes or no),~and using centered baseline detrusor LPP as covariate."||1.29|-13.72|0.1040
70966583|NCT00549939|141439464|SUPERIORITY_OR_OTHER||LS Mean difference versus Placebo|-7.1|STANDARD_ERROR_OF_MEAN|3.77||0.104|TWO_SIDED|95.0|-14.51|0.39||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA|||||0.39|-14.51|0.1040
70966584|NCT00549939|141439465|SUPERIORITY_OR_OTHER||LS Mean difference versus Placebo|-11.4|STANDARD_ERROR_OF_MEAN|7.54||0.1338|TWO_SIDED|95.0|-26.27|3.53||P-values was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA|||"Change in detrusor LPP was analyzed using a three-way analysis of covariance (ANCOVA) including 3 variables as fixed effects:~* treatment group (alfuzosin 0.1 mg/kg/day, alfuzosin 0.2 mg/kg/day or placebo),~* age/formulation group (2-7 years of age on solution, 8-16 years of age on solution or 8-16 years of age on tablets),~* anticholinergic/antimuscarinic use (yes or no),~and using centered baseline detrusor LPP as covariate."||3.53|-26.27|0.1338
70966585|NCT00549939|141439465|SUPERIORITY_OR_OTHER||LS Mean difference versus Placebo|-14.3|STANDARD_ERROR_OF_MEAN|7.48||0.1152|TWO_SIDED|95.0|-29.1|0.47||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA|||||0.47|-29.10|0.1152
70966586|NCT00549939|141439467|SUPERIORITY_OR_OTHER|||||||0.7889||||||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA|||"Change in detrusor compliance was analyzed using a three-way analysis of covariance (ANCOVA) including 3 variables as fixed effects:~* treatment group (alfuzosin 0.1 mg/kg/day, alfuzosin 0.2 mg/kg/day or placebo),~* age/formulation group (2-7 years of age on solution, 8-16 years of age on solution or 8-16 years of age on tablets),~* anticholinergic/antimuscarinic use (yes or no),~and using centered baseline detrusor compliance as covariate."||||0.7889
70966587|NCT00549939|141439467|SUPERIORITY_OR_OTHER|||||||0.7889||||||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA|||||||0.7889
70966588|NCT00003895|141439489|SUPERIORITY_OR_OTHER||||||<|0.001||||||Post versus Pre-treatment % g209-2M-specific t-cells|t-test, 2 sided|||||||<.001
70966589|NCT00003895|141439489|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Post versus Pre-Treatment %g209-2M-specific T-cells|t-test, 2 sided|||||||<.0001
70966590|NCT00003895|141439489|SUPERIORITY_OR_OTHER|||||||0.59||||||Arm A Versus Arm B|t-test, 2 sided|||||||0.59
70966591|NCT03634397|141439490|OTHER||Mean Difference (Final Values)|5.73|||<|0.05|TWO_SIDED|95.0|2.31|9.14||P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|Regression, Linear||The delta values of the outcome from baseline 2 to post-treatment 1 were directly modeled using linear regression with adjustment for age, female sex, and the hemisphere affected by the stroke.|||9.14|2.31|<.05
70966592|NCT03634397|141439492|OTHER|P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|Mean Difference (Final Values)|0.83|||<|0.05|TWO_SIDED|95.0|-2.58|4.24||P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|Regression, Linear|P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.||||4.24|-2.58|<.05
70966593|NCT03634397|141439493|OTHER|P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|Median Difference (Final Values)|1.12|||<|0.05|TWO_SIDED|95.0|-2.29|4.53||P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|Regression, Linear|P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|||4.53|-2.29|<.05
70966594|NCT02752035|141439505|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.523|TWO_SIDED|95.0|0.57|1.329|||Log Rank||Based on Cox proportional hazards model.|Stratification factors were age group per IRT, risk groups and baseline FLT3 mutation status, with potential of strata pooling.||1.329|0.570|0.523
70966595|NCT02752035|141439506|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.787|TWO_SIDED|95.0|0.635|1.393|||Log Rank||Based on Cox proportional hazards model.|Stratification factors were age group per IRT, risk groups and baseline FLT3 mutation status, with potential of strata pooling.||1.393|0.635|0.787
70966596|NCT02752035|141439508|SUPERIORITY||Treatment Difference|8.2||||0.249|TWO_SIDED|95.0|-6.5|23.0||Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.|Cochran-Mantel-Haenszel|||||23.0|-6.5|0.249
70966597|NCT02752035|141439509|SUPERIORITY||Treatment Difference|33.3|||<|0.001|TWO_SIDED|95.0|16.6|50.0||Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.|Cochran-Mantel-Haenszel|||||50.0|16.6|<0.001
70966598|NCT02752035|141439510|SUPERIORITY||Treatment Difference|8.5||||0.049|TWO_SIDED|95.0|-0.1|17.1||Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.|Cochran-Mantel-Haenszel|||||17.1|-0.1|0.049
70966599|NCT02752035|141439511|SUPERIORITY||Treatment Difference|16.7||||0.032|TWO_SIDED|95.0|1.1|32.4||Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.|Cochran-Mantel-Haenszel|||||32.4|1.1|0.032
70966600|NCT02752035|141439512|SUPERIORITY||Treatment Difference|-9.0||||0.34|TWO_SIDED|95.0|-29.8|11.0||Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.|Cochran-Mantel-Haenszel|||||11.0|-29.8|0.340
70966601|NCT02752035|141439513|SUPERIORITY||Treatment Difference|50.0||||0.221|TWO_SIDED|95.0|-61.0|100.0||Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.|Cochran-Mantel-Haenszel|||||100.0|-61.0|0.221
70966602|NCT02752035|141439514|SUPERIORITY||Hazard Ratio (HR)|0.844||||0.592|TWO_SIDED|95.0|0.451|1.58|||Log Rank||Based on Cox proportional hazards model adjusting age group per IRT.|||1.580|0.451|0.592
70904058|NCT01872910|141296686|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-39.4|||||TWO_SIDED|95.0|-53.2|-25.3|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 24 h.|||-25.3|-53.2|
70904059|NCT01872910|141296686|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-1.5|1.6|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 4 h.|||1.6|-1.5|
70904060|NCT01872910|141296686|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-2.9|2.4|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 6 h.|||2.4|-2.9|
70904061|NCT01872910|141296686|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-4.7|3.1|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 8 h.|||3.1|-4.7|
70904062|NCT01872910|141296686|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.1|||||TWO_SIDED|95.0|-8.3|4.1|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 12 h.|||4.1|-8.3|
70904063|NCT01872910|141296686|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0|||||TWO_SIDED|95.0|-21.4|7.6|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 24 h.|||7.6|-21.4|
70904064|NCT01872910|141296687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.3|||||TWO_SIDED|95.0|-4.2|14.5|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 4 h.|||14.5|-4.2|
70904065|NCT01872910|141296687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-32.0|||||TWO_SIDED|95.0|-41.5|-22.4|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 4 h.|||-22.4|-41.5|
70904066|NCT01872910|141296687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|37.3|||||TWO_SIDED|95.0|27.8|46.5|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 4 h.|||46.5|27.8|
70904067|NCT01872910|141296687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.3|||||TWO_SIDED|95.0|-2.9|17.6|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 6 h.|||17.6|-2.9|
70904068|NCT01872910|141296687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-35.1|||||TWO_SIDED|95.0|-45.6|-24.6|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 6 h.|||-24.6|-45.6|
70904069|NCT01872910|141296687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|42.5|||||TWO_SIDED|95.0|32.1|52.7|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 6 h.|||52.7|32.1|
70904070|NCT01872910|141296687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.7|||||TWO_SIDED|95.0|-1.0|23.0|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 12 h.|||23.0|-1.0|
70904071|NCT01872910|141296687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-32.7|||||TWO_SIDED|95.0|-45.1|-20.3|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 12 h.|||-20.3|-45.1|
70904072|NCT01872910|141296687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|43.5|||||TWO_SIDED|95.0|31.3|55.5|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 12 h.|||55.5|31.3|
70904073|NCT01872910|141296687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.4|||||TWO_SIDED|95.0|-1.6|26.2|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 24 h.|||26.2|-1.6|
70904074|NCT01872910|141296687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-30.2|||||TWO_SIDED|95.0|-44.0|-16.0|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 24 h.|||-16.0|-44.0|
70904075|NCT01872910|141296687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|42.6|||||TWO_SIDED|95.0|28.6|56.5|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 24 h.|||56.5|28.6|
70904076|NCT01872910|141296687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6|||||TWO_SIDED|95.0|-9.7|12.9|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 4 h.|||12.9|-9.7|
70904077|NCT01872910|141296687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.5|||||TWO_SIDED|95.0|-9.8|16.8|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 6 h.|||16.8|-9.8|
70904078|NCT01872910|141296687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.5|||||TWO_SIDED|95.0|-9.9|19.0|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 8 h.|||19.0|-9.9|
70904079|NCT01872910|141296687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.9|||||TWO_SIDED|95.0|-9.2|21.1|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 12 h.|||21.1|-9.2|
70904080|NCT01872910|141296687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|-8.4|24.2|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 24 h.|||24.2|-8.4|
70904081|NCT01872910|141296688|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.6|1.9|||||95% CrI is reported here, not the CI. Estimation is SPID 0 to 4 h.|||1.9|-0.6|
70904082|NCT01872910|141296688|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.9|||||TWO_SIDED|95.0|-4.1|-1.7|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 4 h.|||-1.7|-4.1|
70904083|NCT01872910|141296688|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.5|||||TWO_SIDED|95.0|2.3|4.8|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 4 h.|||4.8|2.3|
70904084|NCT01872910|141296688|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|-0.9|3.2|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 6 h.|||3.2|-0.9|
70904085|NCT01872910|141296688|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.8|||||TWO_SIDED|95.0|-6.8|-2.7|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 6 h.|||-2.7|-6.8|
70904086|NCT01872910|141296688|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.9|||||TWO_SIDED|95.0|3.8|8.0|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 6 h.|||8.0|3.8|
70904087|NCT01872910|141296688|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0|-1.0|4.8|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 8 h.|||4.8|-1.0|
70966603|NCT02752035|141439515|SUPERIORITY||Hazard Ratio (HR)|0.573||||0.3|TWO_SIDED|95.0|0.198|1.658|||Log Rank||Based on Cox proportional hazards model adjusting age group per IRT.|Analysis reported for duration of CR/CRh.||1.658|0.198|0.300
70966604|NCT02752035|141439515|SUPERIORITY||Hazard Ratio (HR)|0.411||||0.171|TWO_SIDED|95.0|0.113|1.504|||Log Rank||Based on Cox proportional hazards model adjusting age group per IRT.|Analysis reported for duration of CR.||1.504|0.113|0.171
70966605|NCT02752035|141439515|SUPERIORITY||Hazard Ratio (HR)|0.691||||0.383|TWO_SIDED|95.0|0.295|1.62|||Log Rank||Based on Cox proportional hazards model adjusting age group per IRT.|Analysis reported for duration of CRc||1.620|0.295|0.383
70966606|NCT02752035|141439515|SUPERIORITY||Hazard Ratio (HR)|999.0||||0.998|TWO_SIDED|95.0|0.001||Upper limit of 95% confidence interval was not estimable due to insufficient number of participants.||Log Rank||Based on Cox proportional hazards model adjusting age group per IRT.|Analysis reported for duration of CRh.|||0.001|0.998
70966607|NCT02752035|141439515|SUPERIORITY||Hazard Ratio (HR)|0.628||||0.174|TWO_SIDED|95.0|0.321|1.229|||Log Rank||Based on Cox proportional hazards model adjusting age group per IRT.|Analysis reported for duration of response.||1.229|0.321|0.174
70966608|NCT02752035|141439516|SUPERIORITY||Least square mean difference|0.5||||0.56|TWO_SIDED|95.0|-1.1|2.0|||ANCOVA|Using analysis of covariance including treatment, age group per IRT and baseline score as covariate.|Least square mean difference and P-value were calculated using AZA as reference.|||2.0|-1.1|0.560
70966609|NCT01846728|141439541|OTHER|||||||0.84||||||Because this was a pilot study, the study was not powered to detect differences over time. the study was performed to generate preliminary data on means and standard deviations|t-test, 2 sided|||||||0.84
70966610|NCT01846728|141439542|OTHER|||||||0.66|||||||t-test, 2 sided|||Because this was a pilot study, the study was not powered to detect differences over time. the study was performed to generate preliminary data on means and standard deviations||||0.66
70966611|NCT01846728|141439543|OTHER|Because this was a pilot study, the study was not powered to detect differences over time. the study was performed to generate preliminary data on means and standard deviations||||||0.92|||||||t-test, 2 sided|||||||0.92
70966612|NCT01846728|141439544|OTHER|||||||0.98|||||||t-test, 2 sided|||Because this was a pilot study, the study was not powered to detect differences over time. the study was performed to generate preliminary data on means and standard deviations||||0.98
70966613|NCT01846728|141439545|OTHER|||||||0.66|||||||t-test, 2 sided|||Because this was a pilot study, the study was not powered to detect differences over time. the study was performed to generate preliminary data on means and standard deviations||||0.66
70966614|NCT02161575|141439546|SUPERIORITY||Median Difference (Final Values)|-30.75|||<|0.0001|TWO_SIDED|95.0|-59.5|-20.5|||Wilcoxon (Mann-Whitney)|Confidence Interval for the Median Change form Baseline||The null hypothesis was that the change in CSRT from baseline to Day 90 was zero||-20.50|-59.50|<0.0001
70966615|NCT02446314|141439569|SUPERIORITY||||||=|0.04|||||||Linear Mixed Model / Baseline Covariate|||||||= .04
70966616|NCT02446314|141439570|SUPERIORITY||||||>|0.05|||||||Linear Mixed Model / Baseline Covariate|||||||> .05
70966617|NCT02446314|141439571|SUPERIORITY||||||>|0.05|||||||Linear Mixed Model / Baseline Covariate|||||||> .05
70966618|NCT02446314|141439572|SUPERIORITY||||||>|0.05|||||||Linear Mixed Model / Baseline Covariate|||||||> .05
70966619|NCT02446314|141439573|SUPERIORITY||||||>|0.05|||||||Linear Mixed Model / Baseline Covariate|||||||> .05
70966620|NCT00496730|141439613|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
70966621|NCT00496730|141439614|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
70966622|NCT00496730|141439615|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
70966623|NCT03654976|141439644|SUPERIORITY||Rate ratio|0.89||||0.5412|TWO_SIDED|95.0|0.6|1.31|||Negative binomial regression||12 SQ-HDM SLIT-tablet as the numerator and placebo SLIT-tablet as the denominator.|The number of clinically relevant asthma exacerbations was analyzed using a negative binomial regression model with a log-link function and the logarithm of the time in years in the efficacy period as offset. The model included treatment, age group (\<12 years, \>=12 years) and region (west: DEU, ESP, FRA, GBR and USA; central: POL; east: BGR, HUN and RUS) as fixed factors. No missing data approach was applied.||1.31|0.60|0.5412
70966624|NCT03654976|141439645|SUPERIORITY||Odds Ratio (OR)|0.7713||||0.4156|TWO_SIDED|95.0|0.41|1.44|||Marginal logistic regression||12 SQ-HDM SLIT-tablet as the numerator and placebo SLIT-tablet as the denominator.|A marginal logistic regression model with a generalized estimating approach was analyzed using treatment, visit, treatment\*visit, age group (\<12 years, \>=12 years) and region (west: DEU, ESP, FRA, GBR and USA; central: POL; east: BGR, HUN and RUS) as fixed factors. Baseline visit was included as a covariate. No missing data approach was applied.||1.44|0.41|0.4156
70966625|NCT03654976|141439646|SUPERIORITY||Odds Ratio (OR)|0.8477||||0.4146|TWO_SIDED|95.0|0.57|1.26|||Marginal logistic regression||12 SQ-HDM SLIT-tablet as the numerator and placebo SLIT-tablet as the denominator.|A marginal logistic regression model with a generalized estimating approach was analyzed using treatment, visit, treatment\*visit, age group (\<12 years, \>=12 years) and region (west: DEU, ESP, FRA, GBR and USA; central: POL; east: BGR, HUN and RUS) as fixed factors. Baseline visit is included as a covariate. No missing data approach was applied.||1.26|0.57|0.4146
70966626|NCT03654976|141439647|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.8829|TWO_SIDED|95.0|-1.47|1.7|||Mixed-effect model repeated measurement||12 SQ-HDM - placebo|A 'mixed-effect model repeated measurement' model was analysed using treatment, visit, treatment\*visit, age group (\<12 years, \>=12 years) and region (west: DEU, ESP, FRA, GBR and USA; central: POL; east: BGR, HUN and RUS) as fixed factors. Baseline visit was included as a covariate. No missing data approach was applied.||1.70|-1.47|0.8829
70966627|NCT03654976|141439648|SUPERIORITY||Odds Ratio (OR)|2.26||||0.0044|TWO_SIDED|95.0|1.29|3.96|||Generalised linear mixed model||12 SQ-HDM SLIT-tablet as the numerator and placebo SLIT-tablet as the denominator.|The odds of having an improved outcome was analyzed using a generalized linear mixed model (GLMM) with a logit link function. The model included treatment, age group (\<12 years, \>=12 years) and region (west: DEU, ESP, FRA, GBR and USA; central: POL; east: BGR, HUN and RUS) as fixed factors. No missing data approach was applied.||3.96|1.29|0.0044
70966628|NCT03654976|141439649|SUPERIORITY||Odds Ratio, log|1.62||||0.0698|TWO_SIDED|95.0|0.96|2.74|||Generalised linear mixed model||12 SQ-HDM SLIT-tablet as the numerator and placebo SLIT-tablet as the denominator.|The odds of having an improved outcome was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model included treatment, age group (\<12 years, \>=12 years) and region (west: DEU, ESP, FRA, GBR and USA; central: POL; east: BGR, HUN and RUS) as fixed factors. No missing data approach was applied.||2.74|0.96|0.0698
70966629|NCT00427349|141439677|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||one sample binomial test|The study result was compared to a null hypothesis of 20% 4-month progression free survival rate using one sample binomial test||The null hypothesis is that the 4-month progression free survival rate is 20%. Alternatively, AMG 706 will be considered worthy of further study if its true progression-free survival rate is 40% or better at 4 months (alternative hypothesis).||||<0.001
70966630|NCT00698997|141439699|OTHER|Non- equivalence.|slope difference|1.01||||0.03|TWO_SIDED||||||Mixed Models Analysis|||We used a generalized linear mixed model (GLMM). Change-over-Time was modeled as a linear within-subject effect of time across all observed data for each participant. We fit splines to manage the differing lengths of time in parent-training versus direct treatment. In all analyses, site was included as a categorical covariate to account for potential differences. Effect sizes were reported following Cohen's recommendations as f2.||||.03
70966631|NCT05082376|141439722|OTHER||Adjusted Mean Difference|7.7|||<|0.0001|TWO_SIDED|95.0|6.6|8.8|||ANCOVA|Analysis of Covariance (ANCOVA) model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 2 hours post-treatment||8.8|6.6|<0.0001
70966632|NCT05082376|141439722|OTHER||Adjusted Mean Difference|6.9|||<|0.0001|TWO_SIDED|95.0|5.8|7.9|||ANCOVA|ANCOVA model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 4 hours post-treatment.||7.9|5.8|<0.0001
70966633|NCT05082376|141439722|OTHER||Adjusted Mean Difference|5.1|||<|0.0001|TWO_SIDED|95.0|4.0|6.2|||ANCOVA|ANCOVA model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 6 hours post-treatment.||6.2|4.0|<0.0001
70966634|NCT05082376|141439722|OTHER||Adjusted Mean Difference|4.7|||<|0.0001|TWO_SIDED|95.0|3.6|5.8|||ANCOVA|ANCOVA model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 8 hours post-treatment.||5.8|3.6|<0.0001
70966635|NCT01877915|141439724|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.27|TWO_SIDED|95.0|0.84|1.05|||Log Rank|||Statistical Analysis 1||1.05|0.84|0.270
70966636|NCT01877915|141439730|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.951|TWO_SIDED|95.0|0.41|2.59|||Log Rank|||Statistical Analysis 1 (Fatal Bleeding)||2.59|0.41|0.951
70966637|NCT01877915|141439730|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.253|TWO_SIDED|95.0|0.33|1.34|||Log Rank|||Statistical Analysis 2 (Bleeding in Critical Space with Potential for Permanent Disability)||1.34|0.33|0.253
70966638|NCT00943579|141439733|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Chi-squared|||Chi-square analyses were used to assess CGI-I scores. there were no transformations.||||>.05
70966639|NCT02414399|141439751|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.58|TWO_SIDED|95.0|0.64|1.29||Alpha =0.045 (to account for .005 alpha spending at interim analysis)|Regression, Cox||azithromycin is the numerator and placebo is the denominator|Death or rehospitalization||1.29|.64|0.58
70966640|NCT02414399|141439751|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.49|TWO_SIDED|95.0|0.39|1.58|||Regression, Cox||Azithromycin-numerator and placebo-denominator|Death alone||1.58|0.39|0.49
70966641|NCT02414399|141439751|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.94|TWO_SIDED|95.0|0.7|1.47|||Regression, Cox||numerator-azithromycin denominator-placebo|Rehospitalization alone||1.47|.70|.94
70966642|NCT02414399|141439759|SUPERIORITY|We modelled azithromycin resistance in E coli at baseline, 3 months, and 6 months of follow-up by randomisation group using generalised estimating equations with a Poisson link and exchangeable correlation structure, including site in the model. Models included an interaction term between randomisation group and follow-up timepoint (month 3 or month 6) to test whether an effect on resistance waned with time.||||||0.77|||||||Chi-squared|||M0||||0.77
70966643|NCT02414399|141439759|SUPERIORITY|We modelled azithromycin resistance in E coli at baseline, 3 months, and 6 months of follow-up by randomisation group using generalised estimating equations with a Poisson link and exchangeable correlation structure, including site in the model. Models included an interaction term between randomisation group and follow-up timepoint (month 3 or month 6) to test whether an effect on resistance waned with time.||||||0.088|||||||Chi-squared|||Month 3||||0.088
70966644|NCT02414399|141439759|SUPERIORITY|We modelled azithromycin resistance in E coli at baseline, 3 months, and 6 months of follow-up by randomisation group using generalised estimating equations with a Poisson link and exchangeable correlation structure, including site in the model. Models included an interaction term between randomisation group and follow-up timepoint (month 3 or month 6) to test whether an effect on resistance waned with time.||||||0.44|||||||Chi-squared|||M6||||0.44
70966645|NCT00937937|141439766|SUPERIORITY_OR_OTHER_LEGACY||1-year overall survival estimate|0.38|||||TWO_SIDED|95.0|0.27|0.49||||||one-year overall survival estimate.||0.49|0.27|
70966646|NCT00937937|141439767|SUPERIORITY_OR_OTHER_LEGACY||6-month PFS estimate|0.07|||||TWO_SIDED|95.0|0.03|0.15||||||6-month PFS estimate.||0.15|0.03|
70966647|NCT04024228|141439772|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% Confidence Interval (CI) for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.9|||||TWO_SIDED|95.0|1.58|2.28||||||A/H1N1: 60-64 years||2.28|1.58|
70966648|NCT04024228|141439772|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.7|||||TWO_SIDED|95.0|1.38|2.08||||||A/H3N2: 60-64 years||2.08|1.38|
70966649|NCT04024228|141439772|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.51|||||TWO_SIDED|95.0|1.3|1.74||||||B1: 60-64 years||1.74|1.30|
70966650|NCT04024228|141439772|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.77|||||TWO_SIDED|95.0|1.53|2.04||||||B2: 60-64 years||2.04|1.53|
70966651|NCT04024228|141439772|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.76|||||TWO_SIDED|95.0|1.44|2.15||||||A/H1N1: \>=65 years||2.15|1.44|
70966652|NCT04024228|141439772|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|2.15|||||TWO_SIDED|95.0|1.74|2.65||||||A/H3N2: \>=65 years||2.65|1.74|
70966653|NCT04024228|141439772|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.55|||||TWO_SIDED|95.0|1.34|1.79||||||B1: \>=65 years||1.79|1.34|
70966654|NCT04024228|141439772|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.76|||||TWO_SIDED|95.0|1.52|2.03||||||B2: \>=65 years||2.03|1.52|
70966655|NCT05714982|141439835|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
70966656|NCT05714982|141439835|SUPERIORITY|||||||0.78|||||||General linear model|||||||.78
70966657|NCT05714982|141439836|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
70966658|NCT05714982|141439836|SUPERIORITY|||||||0.66|||||||General linear model|||||||.66
70966659|NCT05714982|141439837|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
70966660|NCT05714982|141439837|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
70966661|NCT05714982|141439838|SUPERIORITY|||||||0.001|||||||General linear model|||||||.001
70966662|NCT05714982|141439838|SUPERIORITY|||||||0.95|||||||General linear model|||||||.95
70966663|NCT05714982|141439839|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
70904088|NCT01872910|141296688|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|||||TWO_SIDED|95.0|-9.0|-3.3|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 8 h.|||-3.3|-9.0|
70966664|NCT05714982|141439839|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
70966665|NCT05714982|141439840|SUPERIORITY||||||<|0.0001|||||||General linear model|||||||<.0001
70966666|NCT05714982|141439840|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
70966667|NCT05714982|141439841|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
70966668|NCT05714982|141439841|SUPERIORITY|||||||0.4|||||||General linear model|||||||.4
70904089|NCT01872910|141296688|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.0|||||TWO_SIDED|95.0|5.1|10.9|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 8 h.|||10.9|5.1|
70904090|NCT01872910|141296688|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.4|||||TWO_SIDED|95.0|-1.3|8.1|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 12 h.|||8.1|-1.3|
70904091|NCT01872910|141296688|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.2|||||TWO_SIDED|95.0|-12.9|-3.5|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 12 h.|||-3.5|-12.9|
70904092|NCT01872910|141296688|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.6|||||TWO_SIDED|95.0|7.0|16.5|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 12 h.|||16.5|7.0|
70904093|NCT01872910|141296688|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|-2.6|18.3|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 24 h.|||18.3|-2.6|
70904094|NCT01872910|141296688|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.1|||||TWO_SIDED|95.0|-24.7|-3.6|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 24 h.|||-3.6|-24.7|
70904095|NCT01872910|141296688|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.9|||||TWO_SIDED|95.0|11.5|32.2|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 24 h.|||32.2|11.5|
70904096|NCT01872910|141296688|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-1.6|1.0|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 4 h.|||1.0|-1.6|
70904097|NCT01872910|141296688|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-2.2|2.1|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 6 h.|||2.1|-2.2|
70904098|NCT01872910|141296688|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-2.9|3.3|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 8 h.|||3.3|-2.9|
70904099|NCT01872910|141296688|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0|-3.9|5.7|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 12 h.|||5.7|-3.9|
70904100|NCT01872910|141296688|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.1|||||TWO_SIDED|95.0|-6.8|15.0|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 24 h.|||15.0|-6.8|
70904101|NCT01872910|141296689|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.85|||||TWO_SIDED|95.0|0.99|3.46|||||Hazard ratio (HR) of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||3.46|0.99|
70904102|NCT01872910|141296689|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.34|||||TWO_SIDED|95.0|0.16|0.72|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||0.72|0.16|
70904103|NCT01872910|141296689|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|5.48|||||TWO_SIDED|95.0|2.69|11.16|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||11.16|2.69|
70904104|NCT01872910|141296689|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.22|||||TWO_SIDED|95.0|0.57|2.59|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||2.59|0.57|
70966669|NCT05714982|141439842|SUPERIORITY|||||||0.03|||||||General linear model|||||||.03
70966670|NCT05714982|141439842|SUPERIORITY|||||||0.4|||||||General linear model|||||||.4
70966671|NCT05714982|141439843|SUPERIORITY|||||||0.61|||||||General linear model|||||||.61
70966672|NCT05714982|141439843|SUPERIORITY|||||||0.68|||||||General linear model|||||||.68
70966673|NCT05714982|141439844|SUPERIORITY|||||||0.4|||||||General linear model|||||||.4
70966674|NCT05714982|141439844|SUPERIORITY|||||||0.5|||||||General linear model|||||||.5
70966675|NCT05714982|141439845|SUPERIORITY|||||||0.001|||||||General linear model|||||||.001
70966676|NCT05714982|141439845|SUPERIORITY|||||||0.9|||||||General linear model|||||||.9
70966677|NCT05714982|141439846|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.73|1.2||||||||1.2|.73|
70966678|NCT05714982|141439846|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.69|1.2||||||||1.2|.69|
70966679|NCT05714982|141439847|SUPERIORITY||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.3|0.9||||||||.9|.3|
70966680|NCT05714982|141439847|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.6|1.7||||||||1.7|.6|
70966681|NCT05714982|141439848|SUPERIORITY|||||||0.02|||||||General linear model|||||||.02
70966682|NCT05714982|141439848|SUPERIORITY|||||||0.5|||||||General linear model|||||||.5
70966683|NCT05714982|141439849|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
70966684|NCT05714982|141439849|SUPERIORITY|||||||0.004|||||||General linear model|||||||.004
70966685|NCT05714982|141439850|SUPERIORITY|||||||0.3|||||||General linear model|||||||0.3
70966686|NCT05714982|141439850|SUPERIORITY|||||||0.5|||||||General linear model|||||||0.5
70966687|NCT05714982|141439851|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.99|2.1||||||||2.1|.99|
70966688|NCT05714982|141439851|SUPERIORITY||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|1.2|2.6||||||||2.6|1.2|
70966689|NCT05197049|141439852|SUPERIORITY||Adjusted treatment difference:percentage|34.9|||<|0.001|TWO_SIDED|95.0|25.1|44.6|||Mantel Haenszel|Mantel-Haenszel stratum weights and the Sato variance estimator.||||44.6|25.1|< 0.001
70966690|NCT05197049|141439853|SUPERIORITY||Adjusted treatment difference:percentage|19.9|||<|0.001|TWO_SIDED|95.0|10.2|29.6|||Mantel Haenszel|Mantel-Haenszel stratum weights and the Sato variance estimator.||||29.6|10.2|< 0.001
70966691|NCT05197049|141439854|SUPERIORITY||Adjusted treatment difference:percentage|37.0|||<|0.001|TWO_SIDED|95.0|25.6|48.4|||Mantel Haenszel|Mantel-Haenszel stratum weights and the Sato variance estimator.||||48.4|25.6|< 0.001
70966692|NCT05197049|141439854|SUPERIORITY||Adjusted treatment difference:percentage|39.3|||<|0.001|TWO_SIDED|95.0|28.0|50.7|||Mantel Haenszel|Mantel-Haenszel stratum weights and the Sato variance estimator.||||50.7|28.0|< 0.001
70966693|NCT05197049|141439855|SUPERIORITY||Adjusted treatment difference:percentage|32.1|||<|0.001|TWO_SIDED|95.0|22.9|41.2|||Mantel Haenszel|Mantel-Haenszel stratum weights and the Sato variance estimator.||||41.2|22.9|< 0.001
70966694|NCT05197049|141439856|SUPERIORITY||Adjusted treatment difference:percentage|40.3|||<|0.001|TWO_SIDED|95.0|29.9|50.7|||Mantel Haenszel|Mantel-Haenszel stratum weights and the Sato variance estimator.||||50.7|29.9|< 0.001
70966695|NCT00309465|141439860|SUPERIORITY_OR_OTHER|||||||0.332||95.0||||P-value for three dosing strategies in insulin glargine only group in fasting blood glucose achievement of 100-179 mg/dl range.|Chi-squared|||Comparison for Target Blood Glucose Achievement of 100-179 mg/dl||||0.332
70966696|NCT00309465|141439860|SUPERIORITY_OR_OTHER|||||||0.294||95.0||||P value is for three strategies in insulin glargine plus bolus group for fasting blood glucose achievement of 100-179 mg/dl|Chi-squared|||Comparison for Target Achievement of blood glucose values of 100-179 mg/dl||||0.294
70966697|NCT00309465|141439860|SUPERIORITY_OR_OTHER|||||||0.162||95.0||||P value is for three strategies in insulin glargine only group for achievement of 80-249 mg/dl|Chi-squared|||Comparison of Achievement of blood glucose values of 80-249 mg/dl||||0.162
70966698|NCT00309465|141439860|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||P value is for three strategies in insulin glargine plus bolus group in achievement of fasting blood glucose value of 80-249 mg/dl.|Chi-squared|||Comparison of Achievement of blood glucose values of 80-249 mg/dl.||||0.031
70966699|NCT02577406|141439861|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.2288|TWO_SIDED|95.0|0.67|1.1|||Stratified Log Rank||The hazard ratio was from a Cox proportional hazards model stratified by prior intensive therapy for AML and primary refractory|||1.10|0.67|0.2288
70966700|NCT02577406|141439862|SUPERIORITY||Odds Ratio (OR)|6.08|||<|0.0001|TWO_SIDED|95.0|3.32|11.14||p-value from a Cochran-Mantel-Haenszel test comparing the response rates between the AG-221 group and the combined CCR group with stratification factors of prior intensive therapy for AML and primary refractory status|Cochran-Mantel-Haenszel||Odds ratio from logistic regression|||11.14|3.32|<0.0001
70966701|NCT02577406|141439863|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.02|TWO_SIDED|95.0|0.55|0.95|||Stratified Log Rank||The hazard ratio is from a Cox proportional hazards model stratified by prior intensive therapy for AML and primary refractory status.|||0.95|0.55|0.0200
70966702|NCT02577406|141439869|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
70966703|NCT02577406|141439870|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
70966704|NCT02577406|141439871|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
70966705|NCT02577406|141439873|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.41|0.67|||Stratified Log Rank||The hazard ratio was from a Cox proportional hazards model stratified by prior intensive therapy for AML and primary refractory status|||0.67|0.41|<0.0001
70966706|NCT04033445|141439881|SUPERIORITY||Adjusted treatment difference|33.6|||<|0.001|TWO_SIDED|95.0|20.9|46.3|||Cochran-Mantel-Haenszel (CMH) chi-square||Treatment difference between guselkumab group and placebo group was adjusted with CMH weight.|||46.3|20.9|< 0.001
70966707|NCT04033445|141439881|SUPERIORITY||Adjusted treatment difference|33.1|||<|0.001|TWO_SIDED|95.0|20.8|45.4|||CMH chi-square test||Treatment difference between guselkumab group and placebo group was adjusted with CMH weight.|||45.4|20.8|< 0.001
70966708|NCT04033445|141439882|SUPERIORITY||Adjusted treatment difference|14.9|||<|0.001|TWO_SIDED|95.0|9.9|19.9|||CMH chi-square test||Treatment difference between guselkumab group and placebo group was adjusted with CMH weight.|||19.9|9.9|< 0.001
70966709|NCT04033445|141439883|SUPERIORITY||Adjusted treatment difference|25.2|||<|0.001|TWO_SIDED|95.0|16.4|33.9|||Cochran-Mantel-Haenszel||Treatment difference between guselkumab group and placebo group was adjusted with CMH weight.|||33.9|16.4|< 0.001
70966710|NCT04033445|141439883|SUPERIORITY||Adjusted treatment difference|29.5|||<|0.001|TWO_SIDED|95.0|20.9|38.1|||Cochran-Mantel-Haenszel||Treatment difference between guselkumab group and placebo group was adjusted with CMH weight.|||38.1|20.9|< 0.001
70966711|NCT04754802|141439924|SUPERIORITY||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|2.42||0.5063|TWO_SIDED|95.0|-3.2|6.4|||ANCOVA|||||6.4|-3.2|.5063
70966712|NCT04754802|141439925|SUPERIORITY||Other|-0.015||||0.8077|TWO_SIDED|95.0|-0.137|0.107|||Wald Normal Approximation (Z)|Wald Normal Approximation (Z) for difference between two proportions||||0.107|-0.137|.8077
70966713|NCT04451161|141439926|SUPERIORITY|||||||0.591||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants administered the CPSS-V to at least one student beginning of the active phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as administered CPSS-V) was binary: either the participant adopted at least one of these components with a student, or they did not at the beginning of the active phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.591
70904105|NCT01872910|141296690|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.78|||||TWO_SIDED|95.0|0.41|1.47|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||1.47|0.41|
70904106|NCT01872910|141296690|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|2.15|||||TWO_SIDED|95.0|1.19|3.88|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||3.88|1.19|
70904107|NCT01872910|141296690|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.36|||||TWO_SIDED|95.0|0.19|0.67|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||0.67|0.19|
70904108|NCT01872910|141296691|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.33|||||TWO_SIDED|95.0|0.12|0.88|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||0.88|0.12|
70904109|NCT01872910|141296691|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|4.16|||||TWO_SIDED|95.0|2.04|8.47|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||8.47|2.04|
70904110|NCT01872910|141296691|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.08|||||TWO_SIDED|95.0|0.03|0.21|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||0.21|0.03|
70904111|NCT01678820|141296711|SUPERIORITY_OR_OTHER||Difference in least squares means|0.19||||0.267|TWO_SIDED|95.0|-0.14|0.52|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment||||0.52|-0.14|0.267
70904112|NCT01678820|141296712|SUPERIORITY_OR_OTHER||Difference in percents|-0.4|||||TWO_SIDED|95.0|-10.2|9.3|||||Based on Miettinen \& Nurminen method|||9.3|-10.2|
70904113|NCT01678820|141296712|SUPERIORITY_OR_OTHER||Difference in percents|-4.3|||||TWO_SIDED|95.0|-14.7|5.8|||||Based on Miettinen \& Nurminen method|||5.8|-14.7|
70904114|NCT01678820|141296714|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.62|||<|0.001|TWO_SIDED|95.0|-0.95|-0.28|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-0.28|-0.95|<0.001
70904115|NCT01678820|141296715|SUPERIORITY_OR_OTHER||Difference in least squares means|1.7||||0.856|TWO_SIDED|95.0|-17.1|20.6|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||20.6|-17.1|0.856
70904116|NCT01678820|141296715|SUPERIORITY_OR_OTHER||Difference in least squares means|-29.2||||0.002|TWO_SIDED|95.0|-47.9|-10.6|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-10.6|-47.9|0.002
70904117|NCT01678820|141296716|SUPERIORITY_OR_OTHER||Difference in least squares means|-25.6|||<|0.001|TWO_SIDED|95.0|-35.6|-15.6|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-15.6|-35.6|<0.001
70904118|NCT01678820|141296716|SUPERIORITY_OR_OTHER||Difference in least squares means|5.3||||0.286|TWO_SIDED|95.0|-4.5|15.2|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||15.2|-4.5|0.286
70904119|NCT01678820|141296717|SUPERIORITY_OR_OTHER||Difference in least squares means|-18.1|||<|0.001|TWO_SIDED|95.0|-24.2|-12.0|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-12.0|-24.2|<0.001
70904120|NCT01678820|141296717|SUPERIORITY_OR_OTHER||Difference in least squares means|0.0||||0.99|TWO_SIDED|95.0|-6.0|6.0|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||6.0|-6.0|0.990
70904121|NCT01678820|141296718|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.2|||<|0.001|TWO_SIDED|95.0|-28.3|-12.2|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-12.2|-28.3|<0.001
70904122|NCT01678820|141296718|SUPERIORITY_OR_OTHER||Difference in least squares means|2.9||||0.469|TWO_SIDED|95.0|-5.0|10.7|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||10.7|-5.0|0.469
70904123|NCT01678820|141296719|SUPERIORITY_OR_OTHER||Difference in least squares means|-24.4|||<|0.001|TWO_SIDED|95.0|-32.6|-16.3|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-16.3|-32.6|<0.001
70904124|NCT01678820|141296719|SUPERIORITY_OR_OTHER||Difference in least squares means|0.3||||0.937|TWO_SIDED|95.0|-7.7|8.3|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||8.3|-7.7|0.937
70904125|NCT01678820|141296720|SUPERIORITY_OR_OTHER||Difference in estimated means|-15.5||||0.068|TWO_SIDED|95.0|-32.2|1.2|||Robust regression|Using M-estimation with treatment, region, and a covariate for baseline triglycerides (mg/dL). Missing data were imputed by multiple imputations.||||1.2|-32.2|0.068
70904126|NCT01678820|141296720|SUPERIORITY_OR_OTHER||Difference in estimated means|-10.3||||0.365|TWO_SIDED|95.0|-33.6|13.0|||Robust regression|Using M-estimation with treatment, region, and a covariate for baseline triglycerides (mg/dL). Missing data were imputed by multiple imputations.||||13.0|-33.6|0.365
70904127|NCT01678820|141296721|SUPERIORITY_OR_OTHER||Difference in least squares means|0.5||||0.857|TWO_SIDED|95.0|-4.8|5.8|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||5.8|-4.8|0.857
70966714|NCT04451161|141439926|SUPERIORITY|||||||0.032||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants administered the CPSS-V to at least one student by the end of the active phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as administered CPSS-V) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the active phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.032
70904128|NCT01678820|141296721|SUPERIORITY_OR_OTHER||Difference in least squares means|0.4||||0.879|TWO_SIDED|95.0|-4.8|5.6|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||5.6|-4.8|0.879
70904129|NCT01678820|141296722|SUPERIORITY_OR_OTHER||Difference in least squares means|-30.4||||0.004|TWO_SIDED|95.0|-51.0|-9.7|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-9.7|-51.0|0.004
70904130|NCT01678820|141296722|SUPERIORITY_OR_OTHER||Difference in least squares means|-15.3||||0.141|TWO_SIDED|95.0|-35.8|5.1|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||5.1|-35.8|0.141
70904131|NCT01678820|141296723|SUPERIORITY_OR_OTHER||Difference in percents|0.3|||||TWO_SIDED|95.0|-12.2|12.9|||||Based on Miettinen \& Nurminen method. Missing data were imputed by multiple impuattions.|||12.9|-12.2|
70904132|NCT01678820|141296723|SUPERIORITY_OR_OTHER||Difference in percents|12.3|||||TWO_SIDED|95.0|0.7|24.0|||||Based on Miettinen \& Nurminen method. Missing data were imputed by multiple imputations.|||24.0|0.7|
70904133|NCT02066896|141296749|OTHER|ANOVA repeated measures||||||0.05|||||||ANOVA|ANOVA repeated measures||||||0.05
70904134|NCT01373450|141296756|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.87||||0.024|TWO_SIDED|90.0|0.77|0.98|||t-test, 1 sided|||||0.98|0.77|0.024
70904135|NCT01373450|141296757|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.77||||0.004|TWO_SIDED|90.0|0.66|0.9|||t-test, 1 sided|||||0.90|0.66|0.004
70904136|NCT01373450|141296758|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.014|||<|0.001|TWO_SIDED|90.0|0.008|0.019|||t-test, 1 sided|||||0.019|0.008|<0.001
70904137|NCT01373450|141296759|SUPERIORITY_OR_OTHER||Intraclass Correlation Coefficient|0.92|||||TWO_SIDED|90.0|0.72|0.98||||||||0.98|0.72|
70904138|NCT01373450|141296760|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.77||||0.003|TWO_SIDED|90.0|0.66|0.9|||t-test, 1 sided|||||0.90|0.66|0.003
70904139|NCT01373450|141296760|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.58|||<|0.001|TWO_SIDED|90.0|0.45|0.74|||t-test, 1 sided|||||0.74|0.45|<0.001
70904140|NCT01373450|141296760|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.99||||0.473|TWO_SIDED|90.0|0.85|1.16|||t-test, 1 sided|||||1.16|0.85|0.473
70904141|NCT01373450|141296760|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.75||||0.049|TWO_SIDED|90.0|0.56|1.0|||t-test, 1 sided|||||1.00|0.56|0.049
70904142|NCT01373450|141296761|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.021|||<|0.001|TWO_SIDED|90.0|0.015|0.026|||t-test, 1 sided|||||0.026|0.015|<0.001
70904143|NCT01373450|141296761|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.03|||<|0.001|TWO_SIDED|90.0|0.021|0.038|||t-test, 1 sided|||||0.038|0.021|<0.001
70904144|NCT01373450|141296761|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.007||||0.0163|TWO_SIDED|90.0|0.002|0.012|||t-test, 1 sided|||||0.012|0.002|0.0163
70904145|NCT01373450|141296761|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.016||||0.0056|TWO_SIDED|90.0|0.006|0.026|||t-test, 1 sided|||||0.026|0.006|0.0056
70904146|NCT00510458|141296767|OTHER|It is expected that the mean linear wear rate is not more than 0.08 mm per year or 0.05 mm per year superior to the reference control, which was 0.13 mm per year. The reference control was determined from the control group within the Post-approval Study of the ABC and Trident® Systems (NCT00960206).|mean linear wear rate at 5 yrs|0.008|||||TWO_SIDED|90.0|-0.0107|0.0267||||||||.0267|-0.0107|
70904147|NCT00510458|141296768|OTHER|To test if the change from pre-operative HHS compared to the post-operative HHS at all intervals is statistically significant.|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70904148|NCT00510458|141296769|OTHER|To test if the change from pre-operative HHS pain score compared to the post-operative HHS pain score at all intervals is statistically significant.|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70904149|NCT00510458|141296770|OTHER|To test if the change from pre-operative HHS ROM compared to the post-operative HHS ROM at all intervals is statistically significant.|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70904150|NCT00510458|141296771|OTHER|To test if the change from pre-operative SF-12 Physical component score compared to the post-operative SF-12 Physical component score at all intervals is statistically significant.|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70904151|NCT00510458|141296771|OTHER|To test if the change from pre-operative SF-12 Mental component score compared to the post-operative SF-12 Mental component score at 1 year is statistically significant.||||||0.0394|||||||t-test, 2 sided|||||||0.0394
70904152|NCT00510458|141296771|OTHER|To test if the change from pre-operative SF-12 Mental component score compared to the post-operative SF-12 Mental component score at 3 years is statistically significant.||||||0.4974|||||||t-test, 2 sided|||||||0.4974
70904153|NCT00510458|141296771|OTHER|To test if the change from pre-operative SF-12 Mental component score compared to the post-operative SF-12 Mental component score at 5 years is statistically significant.||||||0.677|||||||t-test, 2 sided|||||||0.6770
70904154|NCT00510458|141296772|OTHER|To test if the change from pre-operative LEAS compared to the post-operative LEAS at 1 year and 3 years is statistically significant.|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70904155|NCT00510458|141296772|OTHER|To test if the change from pre-operative LEAS compared to the post-operative LEAS at 5 years is statistically significant.||||||0.0006|||||||t-test, 2 sided|||||||0.0006
70904156|NCT04006925|141296783|OTHER||Median Difference (Net)|-23.5||||0.03|TWO_SIDED|95.0|-41.0|-2.0||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Wilcoxon Signed Rank test|||Within group analysis of change from baseline.||-2.0|-41.0|0.03
70904157|NCT04006925|141296783|OTHER||Median Difference (Net)|-9.0||||0.11|TWO_SIDED|95.0|-21.5|0.0|||Wilcoxon Signed Rank test|||Within group analysis of change from baseline.||0.0|-21.5|0.11
70904158|NCT04006925|141296783|SUPERIORITY||Median Difference (Net)|-14.5||||0.27|TWO_SIDED|95.0|-32.0|11.3||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Mann Whitney U test|||Between group analysis of change from baseline.||11.3|-32.0|0.27
70904159|NCT04006925|141296784|OTHER||Median Difference (Net)|-1.0||||0.02|TWO_SIDED|95.0|-3.0|0.0||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Wilcoxon Signed Rank test|||Within group analysis of change from baseline.||0.0|-3.0|0.02
70904160|NCT04006925|141296784|OTHER||Median Difference (Net)|0.0||||0.83|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon Signed Rank test|||Within group analysis of change from baseline.||1.0|-1.0|0.83
70904161|NCT04006925|141296784|SUPERIORITY||Median Difference (Net)|-1.0||||0.09|TWO_SIDED|95.0|-3.5|0.0||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Mann Whitney U test|||Between group analysis of change from baseline.||0.0|-3.5|0.09
70904162|NCT04006925|141296785|SUPERIORITY|||||||0.08||||||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Mann Whitney U test|||Between group analysis of change from baseline.||||0.08
70904163|NCT04006925|141296786|SUPERIORITY|||||||0.18||||||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Mann Whitney U test|||Between group analysis of change from baseline.||||0.18
70904164|NCT04006925|141296787|OTHER||Median Difference (Net)|-1.0||||0.26|TWO_SIDED|95.0|-7.0|2.0||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Wilcoxon Signed Rank test|||Within group analysis of change from baseline.||2.0|-7.0|0.26
70904165|NCT04006925|141296787|OTHER||Median Difference (Final Values)|-0.5||||0.43|TWO_SIDED|95.0|-3.5|2.0||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Wilcoxon Signed Rank test|||Within group analysis of change from baseline.||2.0|-3.5|0.43
70904166|NCT04006925|141296787|SUPERIORITY||Median Difference (Final Values)|-0.5||||0.65|TWO_SIDED|95.0|-4.0|3.0||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Mann Whitney U test|||Between group analysis of change from baseline.||3.0|-4.0|0.65
70904167|NCT04006925|141296788|OTHER||Mean Difference (Net)|-6.2||||0.23|TWO_SIDED|95.0|-15.2|1.7||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Unpaired T-test|||Within group analysis of change from baseline.||1.7|-15.2|0.23
70904168|NCT04006925|141296788|OTHER||Mean Difference (Net)|0.2||||0.95|TWO_SIDED|95.0|-4.6|4.5||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Unpaired T-test|||Within group analysis of change from baseline.||4.5|-4.6|0.95
70904169|NCT04006925|141296788|SUPERIORITY||Mean Difference (Net)|-6.4||||0.22|TWO_SIDED|95.0|-16.2|3.1||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Paired T-test|||Between group analysis of change from baseline.||3.1|-16.2|0.22
70904170|NCT01755143|141296790|SUPERIORITY_OR_OTHER||Percentage|100.0|||<|0.0001|ONE_SIDED|97.5|97.7|||A priori threshold for statistical significance was 0.025|exact test of binomial proportions|||Null Hypothesis: MRI-related complication-free rate between the MRI scan and one-month post-MRI \<90%.|||97.7|<0.0001
70904171|NCT01755143|141296791|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Risk Difference (RD)|0.0|||||TWO_SIDED|||||A priori threshold for statistical significance was 0.025. Because there were no failures in either group, a p-value could not be calculated.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group -10%.||||
70904172|NCT01755143|141296792|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Risk Difference (RD)|-0.7|||<|0.0001|TWO_SIDED|95.0|-5.4|4.1||A priori threshold for statistical significance was 0.025.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group -10%.||4.1|-5.4|<0.0001
70904173|NCT01755143|141296793|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Risk Difference (RD)|1.6|||<|0.0001|ONE_SIDED|95.0|-3.2|||A priori threshold for statistical significance was 0.05.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group - 10%.|||-3.2|<0.0001
70904174|NCT01755143|141296794|SUPERIORITY_OR_OTHER||Percentage|0.0|||<|0.0001|ONE_SIDED|95.0||1.9|||exact test of binomial proportions|A priori threshold for statistical significance was 0.05.||Null hypothesis: the proportion of subjects with sustained ventricular arrhythmias and asystole during MRI scans \>= 10%.||1.9||<0.0001
70904175|NCT01755143|141296795|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Risk Difference (RD)|0.2||||0.0004|ONE_SIDED|95.0|-4.8||||Farrington-Manning test|A priori threshold for statistical significance was 0.05.||Null hypothesis: % successes MRI group ≤ % successes Control group - 10%.|||-4.8|0.0004
70904176|NCT03757234|141296796|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-2.6|||||TWO_SIDED|95.0|-12.4|6.9|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||6.9|-12.4|
70904177|NCT03757234|141296796|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-9.9|||||TWO_SIDED|95.0|-34.8|5.3|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||5.3|-34.8|
70904178|NCT03757234|141296796|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-5.0|||||TWO_SIDED|95.0|-30.6|8.2|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||8.2|-30.6|
70904179|NCT03757234|141296796|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment Difference|0.9|||||TWO_SIDED|95.0|-22.4|11.8|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||11.8|-22.4|
70904180|NCT03757234|141296797|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-5.4|||||TWO_SIDED|95.0|-23.6|12.7|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||12.7|-23.6|
70904181|NCT03757234|141296797|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-47.7|||||TWO_SIDED|95.0|-71.3|-6.0|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||-6.0|-71.3|
70904182|NCT03757234|141296797|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-10.7|||||TWO_SIDED|95.0|-40.8|15.1|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||15.1|-40.8|
70904183|NCT03757234|141296797|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-36.5|||||TWO_SIDED|95.0|-62.6|-1.1|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||-1.1|-62.6|
70904184|NCT01555164|141296802|SUPERIORITY_OR_OTHER||difference in least squares mean (LSM)|-0.11||||0.306|TWO_SIDED|95.0|-0.31|0.1||P-value from a mixed-effect model including terms for baseline HbA1c value, treatment group, visit week, and treatment by visit week interaction. Unstructured covariance matrix was used.|Mixed Effects Model Analysis||The estimation (LSM) is of the placebo-corrected change from baseline.|Assuming a common standard deviation of 1.2%, an effective sample size of 400 would provide at least 90% power to detect a statistically significant treatment difference of -0.4% (ranolazine vs. placebo) for the reduction of HbA1c from baseline at Week 24 based on a 2-sided alpha of 0.05 and 1:1 randomization.||0.10|-0.31|0.306
70904185|NCT01709305|141296811|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion are met when the upper limit of the two-sided 98.34% CI for the difference in LS means is less than or equal to the pre-specified non-inferiority margin of 0.3%.|Difference in LS Means|0.19|||||TWO_SIDED|98.34|0.02|0.36||||||Pairwise Comparison||0.36|0.02|
70904186|NCT01709305|141296811|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion are met when the upper limit of the two-sided 98.34% CI for the difference in LS means is less than or equal to the pre-specified non-inferiority margin of 0.3%.|Difference in LS Means|0.03|||||TWO_SIDED|98.34|-0.15|0.21||||||Pairwise Comparison||0.21|-0.15|
70904187|NCT01709305|141296811|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion are met when the upper limit of the two-sided 98.34% CI for the difference in LS means is less than or equal to the pre-specified non-inferiority margin of 0.3%.|Difference in LS Means|-0.05|||||TWO_SIDED|98.34|-0.23|0.14||||||Pairwise Comparison||0.14|-0.23|
70904188|NCT01709305|141296813|SUPERIORITY_OR_OTHER||Estimate|-8.4|||<|0.001|TWO_SIDED|95.0|-11.1|-6.1|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||-6.1|-11.1|<0.001
70904189|NCT01709305|141296813|SUPERIORITY_OR_OTHER||Estimate|-2.9||||0.072|TWO_SIDED|95.0|-6.1|0.3|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.3|-6.1|0.072
70904190|NCT01709305|141296813|SUPERIORITY_OR_OTHER||Estimate|-5.3|||<|0.001|TWO_SIDED|95.0|-8.3|-2.5|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||-2.5|-8.3|<0.001
70904191|NCT01709305|141296814|SUPERIORITY_OR_OTHER||Estimate|0.4||||0.158|TWO_SIDED|95.0|-0.3|1.3|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||1.3|-0.3|0.158
70904192|NCT01709305|141296814|SUPERIORITY_OR_OTHER||Estimate|0.0|||>|0.999|TWO_SIDED|95.0|-0.7|0.7|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.7|-0.7|>0.999
70904193|NCT01709305|141296814|SUPERIORITY_OR_OTHER||Estimate|0.2||||0.318|TWO_SIDED|95.0|-0.5|1.0|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||1.0|-0.5|0.318
70904194|NCT01709305|141296815|SUPERIORITY_OR_OTHER||Estimate|0.0||||0.998|TWO_SIDED|95.0|-0.9|0.9|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.9|-0.9|0.998
70904195|NCT01709305|141296815|SUPERIORITY_OR_OTHER||Estimate|-0.2||||0.319|TWO_SIDED|95.0|-1.0|0.5|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.5|-1.0|0.319
70904196|NCT01709305|141296815|SUPERIORITY_OR_OTHER||Estimate|0.0||||0.999|TWO_SIDED|95.0|-0.9|0.9|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.9|-0.9|0.999
70904197|NCT01709305|141296816|SUPERIORITY_OR_OTHER||Estimate|-0.2||||0.651|TWO_SIDED|95.0|-1.3|0.8|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.8|-1.3|0.651
70904198|NCT01709305|141296816|SUPERIORITY_OR_OTHER||Estimate|-0.2||||0.66|TWO_SIDED|95.0|-1.3|0.8|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.8|-1.3|0.660
70904199|NCT01709305|141296816|SUPERIORITY_OR_OTHER||Estimate|0.4||||0.48|TWO_SIDED|95.0|-0.8|1.6|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||1.6|-0.8|0.480
70904200|NCT01709305|141296817|SUPERIORITY_OR_OTHER||Estimate|0.4||||0.158|TWO_SIDED|95.0|-0.3|1.3|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||1.3|-0.3|0.158
70904201|NCT01709305|141296817|SUPERIORITY_OR_OTHER||Estimate|0.0|||>|0.999|TWO_SIDED|95.0|-0.7|0.7|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.7|-0.7|>0.999
70904202|NCT01709305|141296817|SUPERIORITY_OR_OTHER||Estimate|0.2||||0.318|TWO_SIDED|95.0|-0.5|1.0|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||1.0|-0.5|0.318
70904203|NCT02294474|141296824|NON_INFERIORITY|Non-inferiority of SAR342434 over Humalog was demonstrated if upper bound of 2-sided 95% confidence interval(CI) of difference between SAR342434 \& Humalog was \<0.3%.Inverse non-inferiority of Humalog over SAR342434 was tested using hierarchical step-down testing procedure: if non-inferiority of SAR342434 over Humalog was demonstrated,then inverse non-inferiority of Humalog over SAR342434 was tested and demonstrated if lower bound of 2-sided 95% CI of difference between SAR342434 \& Humalog\>-0.3%.|Least Square (LS) Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.072|||TWO_SIDED|95.0|-0.215|0.067|||||SAR342434 vs. Humalog|Analysis was performed using a MMRM approach with treatment groups, randomization strata, visit (Week 12, Week 26) and treatment-by-visit interaction as fixed categorical effects and baseline HbA1c value and baseline HbA1c value-by-visit interaction as continuous fixed covariates. An unstructured correlation matrix was used to model within-participant errors.||0.067|-0.215|
70904204|NCT05200936|141296839|SUPERIORITY|||||||0.7145||||||p-value is 1-sided|Mixed Models Analysis|||||||0.7145
70904205|NCT05200936|141296840|SUPERIORITY|||||||0.9613|||||||ANCOVA|||||||0.9613
70904206|NCT05879198|141296878|SUPERIORITY|||||||0.473|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in total scale scores.||||.473
70904207|NCT05879198|141296879|SUPERIORITY|||||||0.469|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in total scale scores.||||.469
70904208|NCT05879198|141296880|SUPERIORITY|||||||0.155|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in total scale scores.||||.155
70904209|NCT05879198|141296881|SUPERIORITY|||||||0.346|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in total scale scores.||||.346
70904210|NCT05879198|141296883|SUPERIORITY|||||||0.075|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in AEQ-positive scale scores.||||.075
70904211|NCT05879198|141296883|SUPERIORITY|||||||0.32|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in AEQ-negative scale scores.||||.320
70966715|NCT04451161|141439926|SUPERIORITY|||||||0.054||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants administered the CPSS-V to at least one student by the end of the sustainment phase.|Chi-squared|||One of the primary TF-CBT adoption outcomes (defined as administered CPSS-V) was binary: either the participant adopted at least one of these components with a student at the end of the sustainment phase, or they did not. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.054
70966716|NCT04451161|141439926|SUPERIORITY|||||||0.98||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants started TF-CBT with at least one student at the beginning of the active phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as started TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not at the beginning of the active phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.98
70966717|NCT04451161|141439926|SUPERIORITY|||||||0.068||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants started TF-CBT with at least one student by the end of the active phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as started TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the active phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.068
70966718|NCT04451161|141439926|SUPERIORITY|||||||0.165||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants started TF-CBT with at least one student by the end of the sustainment phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as started TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the sustainment phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.165
70966719|NCT04451161|141439926|SUPERIORITY|||||||0.191||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants completed TF-CBT with at least one student by the end of the active phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as completed TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the active phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.191
70966720|NCT04451161|141439926|SUPERIORITY|||||||0.86||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants completed TF-CBT with at least one student at the end of the sustainment phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as completed TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the sustainment phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.86
70966721|NCT04451161|141439927|SUPERIORITY||Slope|3.425|STANDARD_ERROR_OF_MEAN|2.783||0.22|TWO_SIDED|95.0|-2.064|8.915||Mixed model analysis was used (students were clustered under the providers who recruited them) to understand if BASIS+TF-CBT has a greater effect on decreasing trauma PTSD symptoms (measured using CPSS-V) over time.|Mixed Models Analysis|||We compared the BASIS group (receiving TF-CBT) against Enhanced Treatment as Usual to evaluate whether TF-CBT reduced trauma-related PTSD symptoms over time, as measured by CPSS-V scores (higher scores indicate greater symptom severity).||8.915|-2.064|0.22
70966722|NCT04451161|141439927|SUPERIORITY||Slope|4.97|STANDARD_ERROR_OF_MEAN|2.774||0.075|TWO_SIDED|95.0|-0.502|10.443||Mixed model analysis was used (the students were clustered under the providers who recruited them) to understand if AC+TF-CBT has a greater effect on decreasing trauma PTSD symptoms (measured using CPSS-V) over time.|Mixed Models Analysis|||We compared the AC group (receiving TF-CBT) against Enhanced Treatment as Usual to evaluate whether TF-CBT reduced trauma-related PTSD symptoms over time, as measured by CPSS-V scores (higher scores indicate greater symptom severity).||10.443|-.502|0.075
70966723|NCT04451161|141439928|SUPERIORITY||Slope|1.024|STANDARD_ERROR_OF_MEAN|0.952||0.284|TWO_SIDED|95.0|-0.855|2.904||Mixed model analysis was used (students were clustered under the providers who recruited them) to understand if BASIS+TF-CBT has a greater effect on decreasing negative mood and feelings symptoms (measured using SMFQ) over time.|Mixed Models Analysis|||We compared the BASIS group (receiving TF-CBT) against Enhanced Treatment as Usual to evaluate whether TF-CBT decreased children's negative moods and feelings due to their trauma (higher score indicates more negative mood and feelings).||2.904|-.855|0.284
70966724|NCT04451161|141439928|SUPERIORITY||Slope|1.908|STANDARD_ERROR_OF_MEAN|0.951||0.046|TWO_SIDED|95.0|0.03|3.786||Mixed model analysis was used (students were clustered under the providers who recruited them) to understand if AC+TF-CBT has a greater effect on decreasing negative mood and feelings symptoms (measured using SMFQ) over time.|Mixed Models Analysis|||We compared the AC group (receiving TF-CBT) against Enhanced Treatment as Usual to evaluate whether TF-CBT decreased children's negative moods and feelings due to their trauma (higher score indicates more negative mood and feelings).||3.786|.03|.046
70966725|NCT03596866|141439940|SUPERIORITY||Hazard Ratio (HR)|0.968|||=|0.8672|TWO_SIDED|95.0|0.658|1.424||P-value from a 2-sided stratified log-rank test using the stratification factors: presence of intracranial central nervous system (CNS) metastases at baseline, and best prior response to crizotinib therapy as assessed by the investigator.|2-sided Stratified Log-rank Test||The hazard ratio was obtained using the stratified Cox regression model with the same stratification factors.|||1.424|0.658|=0.8672
70966726|NCT03596866|141439941|SUPERIORITY||Hazard Ratio (HR)|1.592|||=|0.0713|TWO_SIDED|95.0|0.956|2.652||P-value was based on a 2-sided stratified log-rank test using the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.|Log Rank||The HR was obtained using the stratified Cox regression model with the same stratification factors.|||2.652|0.956|=0.0713
70966727|NCT03596866|141439942|SUPERIORITY||Hazard Ratio (HR)|1.232|||=|0.2501|TWO_SIDED|95.0|0.862|1.761||P-value was based on a 2-sided stratified log-rank test using the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.|Log Rank||The HR was obtained using the stratified Cox regression model with the same stratification factors.|||1.761|0.862|=0.2501
70966728|NCT03596866|141439943|SUPERIORITY||Odds Ratio (OR)|0.7|||=|0.1555|TWO_SIDED|95.0|0.42|1.15||P-value was from a Cochran-Mantel-Haenszel test stratified by the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.|Cochran-Mantel-Haenszel||Odds ratio stratified by the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.|BIRC Assessed||1.15|0.42|=0.1555
70966729|NCT03596866|141439943|SUPERIORITY||Odds Ratio (OR)|0.55|||=|0.0169|TWO_SIDED|95.0|0.33|0.9||P-value was from a Cochran-Mantel-Haenszel test stratified by the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.|Cochran-Mantel-Haenszel||Odds ratio stratified by the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.|Investigator Assessed||0.90|0.33|=0.0169
70966730|NCT03596866|141439946|SUPERIORITY||Odds Ratio (OR)|1.31|||=|0.6246|TWO_SIDED|95.0|0.44|3.84||P-value was from a Cochran-Mantel-Haenszel test stratified by best prior response to crizotinib therapy as assessed by the investigator at randomization per IXRS.|Cochran-Mantel-Haenszel||Odds ratio was stratified by best prior response to crizotinib therapy as assessed by the investigator at randomization per IXRS.|||3.84|0.44|=0.6246
70904212|NCT05879198|141296883|SUPERIORITY|||||||0.049|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in MEEQ-positive scale scores.||||.049
70904213|NCT05879198|141296883|SUPERIORITY|||||||0.089|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in MEEQ-negative scale scores.||||.089
70904214|NCT01693692|141296889|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.25||0.1683|ONE_SIDED|95.0||0.2|||ANCOVA|||||0.2||0.1683
70904215|NCT01693692|141296889|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.25||0.0277|ONE_SIDED|95.0||-0.1|||ANCOVA|||||-0.1||0.0277
70904216|NCT01693692|141296890|SUPERIORITY||Mean Difference (Final Values)|-1.57|STANDARD_ERROR_OF_MEAN|2.48||0.2637|ONE_SIDED|95.0||2.5|||ANCOVA|||||2.5||0.2637
70904217|NCT01693692|141296890|SUPERIORITY||Mean Difference (Final Values)|-5.8|STANDARD_ERROR_OF_MEAN|2.47||0.0097|ONE_SIDED|95.0||-1.7|||ANCOVA|||||-1.7||0.0097
70904218|NCT01693692|141296891|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.16||0.0639|ONE_SIDED|95.0||0.0|||ANCOVA|||||0.0||0.0639
70904219|NCT01693692|141296891|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.16||0.007|ONE_SIDED|95.0||-0.1|||ANCOVA|||||-0.1||0.0070
70904220|NCT00663117|141296892|SUPERIORITY_OR_OTHER|||||||0.009||||||The percentage of subjects achieving a 70-point drop in CDAI score in naltrexone treated subjects was the percentage acheiving the same drop in the placebo controls|Fisher Exact|||The proportion of those achieving a response with a 70-point decline in CDAI score was compared between naltrexone and placebo treated subjects using the Fisher's exact test. Analysis was performed with the intent-to-treat criteria. Clinical significance was accepted if the difference met 95% confidence (p\<0.05).||||0.009
70904221|NCT00663117|141296894|SUPERIORITY_OR_OTHER|||||||0.008|ONE_SIDED|95.0|||||Fisher Exact|||Percentage of patients having a 5-point decline in the endoscopic inflammation score||||0.008
70904222|NCT00663117|141296895|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||t-test, 1 sided|||||||0.048
70904223|NCT02019563|141296900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.34||||0.15|TWO_SIDED|95.0|0.08|1.49|||Chi-squared|||Radiographic outcomes were compared using univariate repeated measures logistic regression. A binary logistic generalized estimating equation model was used to analyze predictor variables such as age, gender, tooth and treatment provider between the treatment groups.||1.49|.08|.15
70904224|NCT02019563|141296901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||0.38|TWO_SIDED|95.0|0.19|1.89|||Chi-squared|||Radiographic outcomes were compared using univariate repeated measures logistic regression. A binary logistic generalized estimating equation model was used to analyze predictor variables such as age, gender, tooth and treatment provider between the treatment groups.||1.89|.19|.38
70904225|NCT02019563|141296902|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||Fisher Exact|||A binary logistic generalized estimating equation (GEE) model was used to analyze predictor variables such as age, gender, tooth and treatment provider between the treatment groups for radiographic and clinical outcomes.||||.51
70904226|NCT02019563|141296903|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||Fisher Exact|||A binary logistic generalized estimating equation (GEE) model was used to analyze predictor variables such as age, gender, tooth and treatment provider between the treatment groups for radiographic and clinical outcomes.||||.64
70904227|NCT02019563|141296904|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED|||||The p-value represents the survival rate from the Kaplan-Meier survival analysis from 6 to 36 months.|Log Rank|||||||.11
70904228|NCT04022889|141296913|NON_INFERIORITY|The null hypothesis of inferiority was to be rejected in favor of the alternative hypothesis of non-inferiority at the two-sided 0.05 significance level if the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.66 × Control) was greater than or equal to zero.|Mean Difference (Final Values)|1.4|STANDARD_DEVIATION|7.7|||TWO_SIDED|95.0|-3.5|6.2|||||The mean treatment difference is defined as Test recovery - (0.66 × Control recovery).|||6.2|-3.5|
70904229|NCT04022889|141296913|NON_INFERIORITY|The null hypothesis of inferiority was to be rejected in favor of the alternative hypothesis of non-inferiority at the two-sided 0.05 significance level if the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.66 × Control) was greater than or equal to zero.|Mean Difference (Final Values)|-0.8|STANDARD_DEVIATION|8.9|||TWO_SIDED|95.0|-6.4|4.8|||||The mean treatment difference is defined as Test recovery - (0.66 × Control recovery).|||4.8|-6.4|
70904230|NCT04022889|141296913|OTHER|Variant 1-BEST = Test Variant 1 Endpoint - Test BEST Endpoint|Mean Difference (Final Values)|1.8|STANDARD_DEVIATION|10.2|||TWO_SIDED|95.0|-5.0|8.7|||||The mean treatment difference is defined as Test recovery - (0.66 × Control recovery).|||8.7|-5.0|
70904231|NCT04022889|141296913|NON_INFERIORITY|The null hypothesis of inferiority was to be rejected in favor of the alternative hypothesis of non-inferiority at the two-sided 0.05 significance level if the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.66 × Control) was greater than or equal to zero.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|5.9|||TWO_SIDED|95.0|-2.5|2.6|||||The mean treatment difference is defined as Test recovery - (0.66 × Control recovery).|||2.6|-2.5|
70904232|NCT04022889|141296914|NON_INFERIORITY|The null hypothesis of inferiority was to be rejected in favor of the alternative hypothesis of non-inferiority at the two-sided 0.05 significance level if the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.58 × Control) was greater than or equal to zero.|Mean Difference (Final Values)|28.9|STANDARD_DEVIATION|16.5|||TWO_SIDED|95.0|18.5|39.4|||||The mean treatment difference is defined as Test survival - (0.58 × Control survival).|||39.4|18.5|
70904233|NCT04022889|141296914|NON_INFERIORITY|The null hypothesis of inferiority was to be rejected in favor of the alternative hypothesis of non-inferiority at the two-sided 0.05 significance level if the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.58 × Control) was greater than or equal to zero.|Mean Difference (Final Values)|25.5|STANDARD_DEVIATION|25.3|||TWO_SIDED|95.0|9.5|41.6|||||The mean treatment difference is defined as Test survival - (0.58 × Control survival).|||41.6|9.5|
70904234|NCT04022889|141296914|EQUIVALENCE|Variant 1-BEST = Test Variant 1 Endpoint - Test BEST Endpoint|Mean Difference (Final Values)|1.6|STANDARD_DEVIATION|21.3|||TWO_SIDED|95.0|-12.7|15.8|||||The mean treatment difference is defined as Test survival - (0.58 × Control survival).|||15.8|-12.7|
70904235|NCT04022889|141296914|NON_INFERIORITY|The null hypothesis of inferiority was to be rejected in favor of the alternative hypothesis of non-inferiority at the two-sided 0.05 significance level if the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.58 × Control) was greater than or equal to zero.|Mean Difference (Final Values)|29.8|STANDARD_DEVIATION|18.5|||TWO_SIDED|95.0|21.8|37.8|||||The mean treatment difference is defined as Test survival - (0.58 × Control survival).|||37.8|21.8|
70904236|NCT01703702|141296968|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.002|TWO_SIDED|95.0|1.22|2.38|||Chi-squared|||||2.38|1.22|0.002
70904237|NCT01703702|141296969|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.35||||0.568|TWO_SIDED|95.0|-1.54|0.84|||ANCOVA|Adjusted for: Baseline ADAS-Cog score, study arm, Alzheimer's treatment, country, and interaction between study arm and Alzheimer's treatment.||||0.84|-1.54|0.568
70904238|NCT01703702|141296970|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|43.9|||<|0.001|TWO_SIDED|95.0|20.0|96.12|||Chi-squared|||||96.12|20|<0.001
70904239|NCT01703702|141296971|SUPERIORITY_OR_OTHER||LS Mean Difference|20.69|||<|0.001|TWO_SIDED|95.0|18.95|22.43|||ANCOVA|Adjusted for: Cognitive status (mild impairment/dementia), physician/practice type, country and florbetapir F18 PET scan result (Aß+/Aß-)||Comparison of change in diagnostic confidence at follow-up (3 months)||22.43|18.95|<0.001
70904240|NCT01703702|141296972|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.144|TWO_SIDED|95.0|0.92|1.78|||Chi-squared|||||1.78|0.92|0.144
70904241|NCT01703702|141296973|SUPERIORITY_OR_OTHER||LS Mean Difference|0.16||||0.925|TWO_SIDED|95.0|-3.2|3.53|||ANCOVA|Adjusted for: Baseline scale, Cognitive status (mild impairment/dementia), country and florbetapir F18 PET scan result (Aß+/Aß-).||||3.53|-3.20|0.925
70904242|NCT01703702|141296974|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.857|TWO_SIDED|95.0|0.7|1.54|||Chi-squared|||Major Diagnostic Tests||1.54|0.70|0.857
70904243|NCT01703702|141296974|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96|||<|0.001|TWO_SIDED|95.0|1.36|2.81|||Chi-squared|||Alzheimer's/Cognitive Medication||2.81|1.36|<0.001
70904244|NCT01703702|141296974|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.063|TWO_SIDED|95.0|0.97|2.64|||Chi-squared|||Neuropsychological Tests||2.64|0.97|0.063
70904245|NCT01703702|141296974|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.741|TWO_SIDED|95.0|0.69|1.7|||Chi-squared|||Physician Follow-up for Re-evaluation||1.70|0.69|0.741
70904246|NCT01703702|141296974|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.046|TWO_SIDED|95.0|1.01|2.08|||Chi-squared|||Specialist Referral||2.08|1.01|0.046
70904247|NCT03980184|141296979|SUPERIORITY|||||||0.08|||||||Fisher Exact|||||||0.08
70904248|NCT03980184|141296980|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<.001
70904249|NCT03980184|141296981|SUPERIORITY|||||||0.703|||||||Fisher Exact|||||||0.703
70904250|NCT03980184|141296983|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
70904251|NCT03980184|141296984|SUPERIORITY|||||||0.647|||||||Fisher Exact|||||||0.647
70904252|NCT03980184|141296985|SUPERIORITY|||||||0.887|||||||Fisher Exact|||||||0.887
70904253|NCT01616771|141296986|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||To verify the difference in C\&L grades using each blade, the ordinal scales of each blade were compared using the Wilcoxon signed rank test. P values and confidence intervals have been corrected for the 3 comparisons.|Wilcoxon (Mann-Whitney)|Hodges-Lehmann method was used to calculate 98.3% CIs of paired differences of 3 comparisons.||An improvement of C\&L grade ordinal scale by 2 was considered a clinically significant change. The mean difference of C\&L grade ordinal scale between DL and GVLw was 1.3, and its standard deviation was 2.0 in our pilot study. The required sample size for the Wilcoxon signed rank test was 21 with an α error of 0.05 and 80% power.||||<0.05
70904254|NCT01616771|141296987|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||To verify the difference in C\&L grades using each blade, the ordinal scales of each blade were compared using the Wilcoxon signed rank test. P values and confidence intervals have been corrected for the 3 comparisons.|Wilcoxon (Mann-Whitney)|Hodges-Lehmann method was used to calculate 98.3% CIs of paired differences of 3 comparisons.||An improvement of C\&L grade ordinal scale by 2 was considered a clinically significant change. The mean difference of C\&L grade ordinal scale between DL and GVLw was 1.3, and its standard deviation was 2.0 in our pilot study. The required sample size for the Wilcoxon signed rank test was 21 with an α error of 0.05 and 80% power.||||<0.05
70904255|NCT01381874|141296992|SUPERIORITY||Hazard Ratio (HR)|1.143||||0.437|TWO_SIDED|95.0|0.816|1.603|||stratified log-rank test|||||1.603|0.816|0.437
70904256|NCT01381874|141296992|SUPERIORITY||Hazard Ratio (HR)|0.958||||0.794|TWO_SIDED|95.0|0.695|1.32|||stratified log-rank test|||||1.320|0.695|0.794
70904257|NCT01381874|141296993|SUPERIORITY||Hazard Ratio (HR)|1.074||||0.807|TWO_SIDED|95.0|0.608|1.896|||stratified log-rank test|||||1.896|0.608|0.807
70904258|NCT01381874|141296993|SUPERIORITY||Hazard Ratio (HR)|1.183||||0.542|TWO_SIDED|95.0|0.688|2.036|||stratified log-rank test|||||2.036|0.688|0.542
70904259|NCT01381874|141296994|SUPERIORITY||Risk Ratio (RR)|0.909||||1|TWO_SIDED|95.0|0.213|3.878|||Fisher Exact|||||3.878|0.213|1.000
70904260|NCT01381874|141296994|SUPERIORITY||Risk Ratio (RR)|1.909||||0.366|TWO_SIDED|95.0|0.605|6.026|||Fisher Exact|||||6.026|0.605|0.366
70904261|NCT01381874|141296995|SUPERIORITY||Risk Ratio (RR)|0.757||||0.603|TWO_SIDED|95.0|0.264|2.175|||Chi-squared|||||2.175|0.264|0.603
70904262|NCT01381874|141296995|SUPERIORITY||Risk Ratio (RR)|1.79||||0.137|TWO_SIDED|95.0|0.816|3.926|||Chi-squared|||||3.926|0.816|0.137
70904263|NCT02247804|141296999|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.39||0.295|TWO_SIDED|95.0|-1.17|0.36|||MMRM|||Change from Baseline Week 12, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Week 12).||0.36|-1.17|0.2950
70904264|NCT02247804|141296999|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.39||0.3904|TWO_SIDED|95.0|-1.09|0.43|||MMRM|||Change from Baseline Week 12, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Week 12).||0.43|-1.09|0.3904
70904265|NCT02247804|141296999|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.35||0.0464|TWO_SIDED|95.0|-1.4|-0.01|||MMRM|||Change from Baseline Week 12, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Week 12).||-0.01|-1.40|0.0464
70904266|NCT02247804|141296999|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.35||0.5383|TWO_SIDED|95.0|-0.9|0.47|||MMRM|||Change from Baseline Week 12, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Week 12).||0.47|-0.90|0.5383
70904267|NCT02247804|141297000|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.34||0.0033|TWO_SIDED|95.0|-1.68|-0.34|||MMRM|||Week 2, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.34|-1.68|0.0033
70904268|NCT02247804|141297000|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.34||0.0187|TWO_SIDED|95.0|-1.47|-0.13|||MMRM|||Week 2, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.13|-1.47|0.0187
70904269|NCT02247804|141297001|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.31||0.0057||95.0|-1.45|-0.25|||MMRM|||Week 2, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.25|-1.45|0.0057
70904270|NCT02247804|141297001|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.3||0.0031||95.0|-1.5|-0.31|||MMRM|||Week 2, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.31|-1.50|0.0031
70904271|NCT02247804|141297002|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.32||0.0547||95.0|-1.26|0.01|||MMRM|||Week 6, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.01|-1.26|0.0547
70966731|NCT03596866|141439948|SUPERIORITY||||||=|0.0778||||||P-value from a 2-sided stratified Gray's test using the stratification factors (at randomization per IxRS): presence of intracranial CNS metastases at baseline, and best prior response to crizotinib therapy as assessed by the investigator.|Gray's Test|P-value is for the event type: Intracranial Disease Progression without Prior Systemic Progression or Death.||||||=0.0778
70966732|NCT01671111|141439956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.056|TWO_SIDED|||||P-value was from paired t-test for post treatment timepoint versus baseline.|paired t-test|||||||0.0560
70966733|NCT01671111|141439957|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1232|TWO_SIDED|||||P-value was from paired t-test for post treatment timepoint versus baseline.|paired t-test|||||||0.1232
70966734|NCT01671111|141439958|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1319|TWO_SIDED|||||P-value was from paired t-test for post treatment timepoint versus baseline.|paired t-test|||||||0.1319
70904272|NCT02247804|141297002|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.32||0.0107||95.0|-1.46|-0.19|||MMRM|||Week 6, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.19|-1.46|0.0107
70904273|NCT02247804|141297003|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.32||0.086||95.0|-1.16|0.08|||MMRM|||Week 6, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.08|-1.16|0.0860
70904274|NCT02247804|141297003|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.31||0.0362||95.0|-1.27|-0.04|||MMRM|||Week 6, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.04|-1.27|0.0362
70904275|NCT02247804|141297004|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.39||0.295||95.0|-1.17|0.36|||MMRM|||Week 12, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.36|-1.17|0.2950
70904276|NCT02247804|141297004|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.39||0.3904|TWO_SIDED|95.0|-1.09|0.43|||MMRM|||Week 12, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.43|-1.09|0.3904
70904277|NCT02247804|141297005|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.35||0.0464||95.0|-1.4|-0.01|||MMRM|||Week 12, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.01|-1.40|0.0464
70904278|NCT02247804|141297005|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.35||0.5383||95.0|-0.9|0.47|||MMRM|||Week 12, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.47|-0.90|0.5383
70904279|NCT02247804|141297006|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.34||0.0033|TWO_SIDED|95.0|-1.68|-0.34|||MMRM|||Change from Baseline Week 2, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.34|-1.68|0.0033
70904280|NCT02247804|141297006|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.34||0.0187|TWO_SIDED|95.0|-1.47|-0.13|||MMRM|||Change from Baseline Week 2, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.13|-1.47|0.0187
70966735|NCT01671111|141439959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8061|TWO_SIDED|||||P-value was from paired t-test for log-transformed data at post treatment timepoint versus baseline.|paired t-test|||||||0.8061
70966736|NCT01671111|141439960|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2297|TWO_SIDED|||||P-value was from paired t-test for log-transformed data at post treatment timepoint versus baseline.|paired t-test|||||||0.2297
70966737|NCT01671111|141439961|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1248|TWO_SIDED|||||P-value was from paired t-test for log-transformed data at post treatment timepoint versus baseline.|paired t-test|||||||0.1248
70904281|NCT02247804|141297006|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.31||0.0057|TWO_SIDED|95.0|-1.45|-0.25|||MMRM|||Change from Baseline Week 2, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.25|-1.45|0.0057
70904282|NCT02247804|141297006|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.3||0.0031|TWO_SIDED|95.0|-1.5|-0.31|||MMRM|||Change from Baseline Week 2, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.31|-1.50|0.0031
70904283|NCT02247804|141297006|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.32||0.0547|TWO_SIDED|95.0|-1.26|0.01|||MMRM|||Change from Baseline Week 6, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.01|-1.26|0.0547
70904284|NCT02247804|141297006|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.32||0.0107|TWO_SIDED|95.0|-1.46|-0.19|||MMRM|||Change from Baseline Week 6, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.19|-1.46|0.0107
70904285|NCT02247804|141297006|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.32||0.086|TWO_SIDED|95.0|-1.16|0.08|||MMRM|||Change from Baseline Week 6, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.08|-1.16|0.0860
70904286|NCT02247804|141297006|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.31||0.0362||95.0|-1.27|-0.04|||MMRM|||Change from Baseline Week 6, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.04|-1.27|0.0362
70904287|NCT02917265|141297023|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
70904288|NCT00985543|141297065|NON_INFERIORITY_OR_EQUIVALENCE|Results are considered statistically significant at p\<0.05 or when 90% confidence intervals do not cross the value 1. No adjustments are made for multiple comparisons.|||||<|0.05|TWO_SIDED|90.0|||||maximum likelihood regression|||Dosing regimens lopinavir/ritonavir 200/150mg BID (Phase 2) and lopinavir/ritonavir 200/50mg BID (Phase 3) will be considered equivalent to lopinavir/ritonavir 400/100mg BID (Phase 1) if the 90% confidence interval (CI) for the mean AUC0-12h ratio and maximum concentration (Cmax) ratio lie between 0.80 and 1.25.||||<0.05
70904289|NCT00114634|141297080|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||||||1.0
70904290|NCT00007475|141297104|SUPERIORITY_OR_OTHER||Proportion with reduced proteinuria|0.6363|STANDARD_ERROR_OF_MEAN|0.0698|<|0.0001|TWO_SIDED|95.0|0.3079|0.8907||Exact binomial test of proportion of participants exhibiting reduction in proteinuria (see definition below), under null hypothesis that the overall proportion is zero.|Exact binomial test|Tested under null hypothesis that the overall proportion is zero.|Proportion event definition: exhibiting reduction in proteinuria post-cyclophosphamide (complete- \[urine protein {UP} \<0.3\] or or partial-remission \[between 0.3 \& 2.0, inclusive\], limited response \[UP between 2.0 \& 3.5\] yet no relapse \[UP 3.5+\]).|No groups compared, yet null hypothesis: pooled proportion = 0, tested using counts pooled across baseline FPF assay-availability groups (7 across 3 arms) excluding 4 non-completers (yielding 7/11 with event below). Given the modest group-specific sample sizes and tendency for zero outcomes to be observed in a group, we employ exact binomial 95% confidence intervals using the method of Clopper and Pearson (1934; calculated along with corresponding tests using Michael Fay's exactci package in R).||0.8907|0.3079|<0.0001
70904291|NCT01225822|141297133|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.375|||<|0.0001||95.0|0.244|0.577||Dose relationship tested using a hierarchical testing procedure to preserve type I error rate at 5%. 225 mg bid was compared to 50 mg bid. If a difference significant at 5% level was found, then 150 mg bid was compared to 50 mg bid|Regression, Logistic|||BIBR 1048 225 mg bid vs. BIBR 1048 50 mg bid comparison. The primary objective of the trial was to establish a dose relationship among BIBR 1048 doses studied in the prevention of VTE. The statistical model was a logistic regression which included treatment and centre..||0.577|0.244|<0.0001
70904292|NCT01225822|141297133|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.518||||0.0015||95.0|0.344|0.778||Dose relationship tested using a hierarchical testing procedure to preserve type I error rate at 5%. 225 mg bid was compared to 50 mg bid. If a difference significant at 5% level was found, then 150 mg bid was compared to 50 mg bid|Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 50 mg bid comparison. The primary objective of the trial was to establish a dose relationship among BIBR 1048 doses studied in the prevention of VTE. The statistical model was a logistic regression which included treatment and centre..||0.778|0.344|0.0015
70966738|NCT02504554|141439967|OTHER||||||<|0.001||||||"no adjustment for multiple hypothesis testing since this was an exploratory study.~the p-value listed is the actual result from analysis of the study data."|Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank analysis of symptoms at 10 weeks (end of treatment) vs. baseline||||<0.001
70966739|NCT02504554|141439968|OTHER|paired 2-sided t-test comparing baseline and 10 weeks (end of treatment)|||||<|0.001||||||no adjustment for multiple comparisons|t-test, 2 sided|paired t-test, 2 sided||||||<0.001
70966740|NCT02504554|141439970|OTHER||||||<|0.001||||||"no adjustment for multiple comparisons~The p-value listed is the result for the actual analysis of the data."|Wilcoxon (Mann-Whitney)|||Wilcoxon signed-rank test comparing the baseline score vs. the score at 10 weeks (end of treatment).||||<0.001
70966741|NCT02504554|141439971|OTHER||||||<|0.001||||||"no adjustment for multiple comparisons~the p-value listed is the actual result for the study results."|Wilcoxon (Mann-Whitney)|||Wilcoxon signed-rank test comparing scores at baseline vs. 10 weeks (end of treatment)||||<0.001
70966742|NCT02504554|141439973|OTHER||||||<|0.001||||||"no adjustment for multiple comparisons~the p-value listed is the actual result for the analysis of the study data"|t-test, 2 sided|||2-sided t-test comparing the group at baseline vs. 18 weeks (8 weeks after end of treatment)||||<0.001
70966743|NCT02504554|141439974|OTHER|||||||0.002||||||no adjustment for multiple comparisons|Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test was used to compare scores at baseline vs. at 10 weeks (end of treatment)||||0.002
70966744|NCT01806857|141439975|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Random Effects Model|||||||0.0003
70966745|NCT01806857|141439979|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Random Effects Model|||||||0.0001
70966746|NCT01020591|141439991|NON_INFERIORITY_OR_EQUIVALENCE|The power and sample size calculations, based on the ability to detect treatment and evaluation group differences, were performed on Minitab™ V.15. 40 participants were estimated to be required for group allocation (20 in each group: evaluation;evaluation and treatment)for 80% power in at least 3 out of the 4 outcome measures. After 30 subjects, analysis determined that there would be no further statistically significant changes in results therefore, data collection was stopped at 30 subjects.|||||<|0.05|TWO_SIDED|95.0|||||ANOVA|||A two factor mixed model Analysis of Variance (ANOVA) for Group (Evaluation vs. Treatment) with repeated measures (pre vs. post test) was employed to test for main effects and all interactions for the Resistive Index||||<0.05
70966747|NCT03023930|141440016|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|proc logistic||||||<0.001
70966748|NCT03023930|141440017|SUPERIORITY|||||||0.011|||||||Regression, Logistic|proc logistic||||||0.011
70966749|NCT00290186|141440043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.539||95.0|-1.5|3.3|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||3.3|-1.5|0.539
70966750|NCT00290186|141440044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.921|TWO_SIDED|95.0|-1.6|1.8|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||1.8|-1.6|0.921
70966751|NCT00290186|141440045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.945|TWO_SIDED|95.0|-3.0|5.1|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||5.1|-3.0|0.945
70966752|NCT00290186|141440046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.342|TWO_SIDED|95.0|-5.1|2.2|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||2.2|-5.1|0.342
70966753|NCT00290186|141440047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.149|TWO_SIDED|95.0|-1.6|8.6|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||8.6|-1.6|0.149
70966754|NCT00290186|141440048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.685|TWO_SIDED|95.0|-3.0|5.1|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||5.1|-3.0|0.685
70966755|NCT00290186|141440049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.584|TWO_SIDED|95.0|-2.4|3.0|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||3.0|-2.4|0.584
70966756|NCT00290186|141440050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.498|TWO_SIDED|95.0|-1.5|3.7|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||3.7|-1.5|0.498
70966757|NCT00290186|141440051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.945|TWO_SIDED|95.0|-2.3|2.2|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||2.2|-2.3|0.945
70966758|NCT00290186|141440052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.932|TWO_SIDED|95.0|-2.1|2.4|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||2.4|-2.1|0.932
70966759|NCT00290186|141440053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3||||0.051|TWO_SIDED|95.0|-0.2|4.7|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||4.7|-0.2|0.051
70966760|NCT00290186|141440054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.648|TWO_SIDED|95.0|-4.0|2.8|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||2.8|-4.0|0.648
70966761|NCT00290186|141440055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.473|TWO_SIDED|95.0|-4.7|1.4|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||1.4|-4.7|0.473
70966762|NCT00290186|141440056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.0||||0.157|TWO_SIDED|95.0|-22.0|114.0|||t-test, 2 sided|||Between-group difference: positive values represent greater improvement in HBO group.||114|-22|0.157
70966763|NCT00290186|141440057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.876|TWO_SIDED|95.0|-15.0|13.0|||t-test, 2 sided|||Between-group difference: positive values represent greater improvement in HBO group.||13|-15|0.876
70966764|NCT00290186|141440058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-79.0||||0.167|TWO_SIDED|95.0|-198.0|41.0|||t-test, 2 sided|||Between-group difference: negative values represent greater improvement in HBO group.||41|-198|0.167
70966765|NCT00290186|141440059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-38.0||||0.468|TWO_SIDED|95.0|-153.0|77.0|||t-test, 2 sided|||Between-group difference: negative values represent greater improvement in HBO group.||77|-153|0.468
70966766|NCT00445224|141440065|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||ANOVA|||||||.041
70966767|NCT00445224|141440066|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||ANOVA|||Repeated measures ANOVA for group and time||||.049
70966768|NCT04391036|141440068|SUPERIORITY||||||>|0.99|||||||McNemar|||This was a paired analysis comparing successful insertion of the high and low Eudragit® Films. The McNemar's test statistic is based on the discordant pairs (number of participants with high successful, low unsuccessful versus low successful, high unsuccessful).||||>.99
70966769|NCT04391036|141440069|SUPERIORITY|||||||0.45||||||This was a paired analysis comparing difficulty of insertion of the high and low Eudragit® Films. The McNemar's test is based on discordant pairs (high was not difficult, low was difficult versus low was not difficult, high was difficult).|McNemar|||||||.45
70966770|NCT04391036|141440070|SUPERIORITY|||||||0.26|||||||Fisher Exact|This was an overall Fisher's exact test so the analysis applies to all categories.||||||.26
70966771|NCT02904915|141440081|SUPERIORITY|||||||0.59|||||||Fisher Exact|||||||0.59
70966772|NCT02904915|141440082|SUPERIORITY|||||||0.39|||||||Fisher Exact|||||||0.39
70966773|NCT02904915|141440083|SUPERIORITY|||||||0.23|||||||Fisher Exact|||||||0.23
70966774|NCT03159091|141440084|SUPERIORITY|||||||0.0422|||||||G-test (Chi-square)|||||||0.0422
70966775|NCT03159091|141440085|SUPERIORITY|||||||0.1101|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between initial and 4 weeks total scores row.||||0.1101
70966776|NCT03159091|141440086|SUPERIORITY|||||||0.1373|||||||G-test (Chi-square)|||||||0.1373
70966777|NCT03159091|141440087|SUPERIORITY|||||||0.087|||||||Wilcoxon (Mann-Whitney)|||||||0.0870
70966778|NCT03159091|141440088|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
70966779|NCT00262522|141440089|SUPERIORITY_OR_OTHER||||||>|0.1||95.0|||||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel (CMH) test stratified by dosing regimen was used to assess the null hypothesis of no difference between the tablet and soft gel capsule (SGC). Sample size was 600 subjects (150 each in the 4 groups). Based on a projected 48% reporting treatment-emergent diarrhea in the QD arm and 32% in the BID arm within the SGC group, with a 12% reduction in the corresponding tablet groups, this sample size provided 80% power to determine a difference between the tablet and SGC.||||>0.100
70966780|NCT00262522|141440090|NON_INFERIORITY_OR_EQUIVALENCE|The 95% confidence interval for the difference in response rates (QD minus BID, based on the normal approximation to the binomial distribution) was used to assess noninferiority. The QD regimen was considered noninferior to the BID regimen if the lower limit of the confidence interval remained above -12%.|percentage of subjects responding|1.3||||0.715||95.0|-5.1|7.8|||normal approx. to the binomial distr.|||The null hypothesis was that the response rate for the once daily (QD) regimen was more than 12% lower than the response rate for the twice daily (BID) regimen. The planned sample size of 600 subjects (300 subjects in each of the QD and BID treatment regimens) provided over 90% power to reject the null hypothesis, i.e., to determine noninferiority based on the 12% margin.||7.8|-5.1|0.715
70966781|NCT00262522|141440091|NON_INFERIORITY_OR_EQUIVALENCE|The 95% confidence interval for the difference in response rates (QD minus BID, based on the normal approximation to the binomial distribution) was used to assess noninferiority. The QD regimen was considered noninferior to the BID regimen if the lower limit of the confidence interval remained above -12%.|percentage of subjects responding|-4.3||||0.249||95.0|-11.5|2.8|||normal approx. to the binomial distr.|||The null hypothesis was that the response rate for the once daily (QD) regimen was more than 12% lower than the response rate for the twice daily (BID) regimen. The planned sample size of 600 subjects (300 subjects in each of the QD and BID treatment regimens) provided over 90% power to reject the null hypothesis, i.e., to determine noninferiority based on the 12% margin.||2.8|-11.5|0.249
70966782|NCT00262522|141440092|SUPERIORITY_OR_OTHER|||||||0.269||95.0|||||ANOVA|||||||0.269
70966783|NCT04085523|141440095|SUPERIORITY||||||=|0.6004|||||||ANCOVA|||ANCOVA model using treatment (dose groups and pooled placebo) and sex as fixed effects, and baseline age and baseline height SDS as the covariates.||||= 0.6004
70966784|NCT04085523|141440095|SUPERIORITY||||||=|0.7022|||||||ANCOVA|||ANCOVA model using treatment (dose groups and pooled placebo) and sex as fixed effects, and baseline age and baseline height SDS as the covariates.||||= 0.7022
70966785|NCT04085523|141440095|SUPERIORITY||||||=|0.0849|||||||ANCOVA|||ANCOVA model using treatment (dose groups and pooled placebo) and sex as fixed effects, and baseline age and baseline height SDS as the covariates.||||= 0.0849
70966786|NCT04085523|141440095|SUPERIORITY||||||=|0.0218|||||||ANCOVA|||ANCOVA model using treatment (dose groups and pooled placebo) and sex as fixed effects, and baseline age and baseline height SDS as the covariates.||||= 0.0218
70966787|NCT04272892|141440096|SUPERIORITY||Mean Difference (Final Values)|3.35|||<|0.021|TWO_SIDED|||||p values are calculated for original data (complete case) and each of the 5 imputed datasets. The p value range was 0.002 - 0.020. This is not multiple statistical analyses- it is just one with multiple imputations.|ANCOVA|Degrees of freedom for original data (complete case): 1,64. Degrees of freedom for imputed datasets: 1,80||||||<0.021
70966788|NCT04272892|141440097|SUPERIORITY||Mean Difference (Final Values)|2.86||||0.059|TWO_SIDED|95.0|-0.106|5.822|||ANCOVA|ANCOVA of score at 8 week follow up with baseline score as covariate, effect of group||||5.822|-.106|0.059
70966789|NCT04272892|141440098|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.596|TWO_SIDED|95.0|-3.5|6.0|||ANCOVA|ANCOVA of sleep fragmentation at post-intervention with baseline as covariate, effect of group||||6.0|-3.5|0.596
70966790|NCT04272892|141440099|SUPERIORITY||Mean Difference (Final Values)|4.5||||0.031|TWO_SIDED|95.0|0.431|8.612|||ANCOVA|ANCOVA of sleep fragmentation at 8 week follow up with baseline as covariate, effect of group||||8.612|.431|0.031
70966791|NCT04272892|141440100|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.885|TWO_SIDED|95.0|-7.8|9.1|||ANCOVA|ANCOVA of wake after sleep onset post-intervention with baseline as covariate, effect of group||||9.1|-7.8|0.885
70966792|NCT04272892|141440101|SUPERIORITY||Mean Difference (Final Values)|8.0||||0.077|TWO_SIDED|95.0|-1.0|17.0|||ANCOVA|ANCOVA of wake after sleep onset at 8 week follow up with baseline as covariate, effect of group||||17|-1|0.077
70966793|NCT04272892|141440102|SUPERIORITY||Mean Difference (Final Values)|10.0||||0.014|TWO_SIDED|95.0|2.0|18.0|||ANCOVA|ANCOVA of sleep onset latency (median of 7 nights) at end of intervention with baseline as covariate, effect of group||||18|2|0.014
70966794|NCT04272892|141440103|SUPERIORITY||Mean Difference (Final Values)|1.8||||0.03|TWO_SIDED|95.0|0.18|3.5|||ANCOVA|ANCOVA of PHQ9 score post-intervention with baseline as covariate, effect of group||||3.5|.18|0.03
70966795|NCT04272892|141440104|SUPERIORITY||Mean Difference (Final Values)|2.29||||0.036|TWO_SIDED|95.0|0.149|4.44|||ANCOVA|ANCOVA of PHQ9 score at 8 week follow up with baseline as covariate, effect of group||||4.44|.149|0.036
70904293|NCT01225822|141297133|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.7856||95.0|0.599|1.473|||Regression, Logistic|||BIBR 1048 300 mg qd vs. BIBR 1048 150 mg bid comparison. Secondary analysis to compare once daily dosing vs. twice daily dosing. . The statistical model was a logistic regression which included treatment and centre.||1.473|0.599|0.7856
70904294|NCT01225822|141297133|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.469||||0.0007||95.0|0.302|0.727|||Regression, Logistic|||BIBR 1048 225 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.||0.727|0.302|0.0007
70904295|NCT01225822|141297133|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.647||||0.0401||95.0|0.427|0.98|||Regression, Logistic|||BIBR 1048 150 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.||0.98|0.427|0.0401
70904296|NCT01225822|141297133|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.249||||0.2446||95.0|0.859|1.817|||Regression, Logistic|||BIBR 1048 50 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.||1.817|0.859|0.2446
70904297|NCT01225822|141297134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.375|||<|0.0001||95.0|0.244|0.577||Dose relationship tested using a hierarchical testing procedure to preserve type I error rate at 5%. 225 mg bid was compared to 50 mg bid. If a difference significant at 5% level was found, then 150 mg bid was compared to 50 mg bid|Regression, Logistic|||BIBR 1048 225 mg bid vs. BIBR 1048 50 mg bid comparison. The primary objective of the trial was to establish a dose relationship among BIBR 1048 doses studied in the prevention of VTE. The statistical model was a logistic regression which included treatment and centre..||0.577|0.244|<0.0001
70904298|NCT01225822|141297134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.518||||0.0015||95.0|0.344|0.778||Dose relationship tested using a hierarchical testing procedure to preserve type I error rate at 5%. 225 mg bid was compared to 50 mg bid. If a difference significant at 5% level was found, then 150 mg bid was compared to 50 mg bid|Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 50 mg bid comparison. The primary objective of the trial was to establish a dose relationship among BIBR 1048 doses studied in the prevention of VTE. The statistical model was a logistic regression which included treatment and centre..||0.778|0.344|0.0015
70904299|NCT01225822|141297134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.7856||95.0|0.599|1.473|||Regression, Logistic|||BIBR 1048 300 mg qd vs. BIBR 1048 150 mg bid comparison. Secondary analysis to compare once daily dosing vs. twice daily dosing. . The statistical model was a logistic regression which included treatment and centre.||1.473|0.599|0.7856
70904300|NCT01225822|141297134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.469||||0.0007||95.0|0.302|0.727|||Regression, Logistic|||BIBR 1048 225 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.||0.727|0.302|0.0007
70904301|NCT01225822|141297134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.647||||0.0401||95.0|0.427|0.98|||Regression, Logistic|||BIBR 1048 150 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.||0.98|0.427|0.0401
70904302|NCT01225822|141297134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.249||||0.2446||95.0|0.859|1.817|||Regression, Logistic|||BIBR 1048 50 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.||1.817|0.859|0.2446
70904303|NCT01225822|141297135|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.334||||0.0373||95.0|0.199|0.938|||Regression, Logistic|||BIBR 1048 225 mg bid vs. BIBR 1048 50 mg bid, same methodology as primary endpoint.||0.938|0.199|0.0373
70904304|NCT01225822|141297135|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.837||||0.6659||95.0|0.374|1.875|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 50 mg bid, same methodology as primary endpoint.||1.875|0.374|0.6659
70904305|NCT01225822|141297135|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.505||||0.1882||95.0|0.183|1.397|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 300 mg qd, same methodology as primary endpoint.||1.397|0.183|0.1882
70904306|NCT01225822|141297135|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.805||||0.5566||95.0|0.39|1.66|||Regression, Logistic|||BIBR 1048 50 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.||1.66|0.39|0.5566
70904307|NCT01225822|141297135|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.674||||0.3253||95.0|0.307|1.48|||Regression, Logistic|||BIBR 1048 150 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.||1.48|0.307|0.3253
70904308|NCT01225822|141297135|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.269||||0.0114||95.0|0.097|0.744|||Regression, Logistic|||BIBR 1048 225 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.||0.744|0.097|0.0114
70904309|NCT01225822|141297136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.332||||0.036||95.0|0.118|0.931|||Regression, Logistic|||BIBR 1048 225 mg bid vs. BIBR 1048 50 mg bid, same methodology as primary endpoint.||0.931|0.118|0.036
70904310|NCT01225822|141297136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.687||||0.3884||95.0|0.293|1.611|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 50 mg bid, same methodology as primary endpoint.||1.611|0.293|0.3884
70904311|NCT01225822|141297136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.616||||0.3674||95.0|0.215|1.766|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 300 mg qd, same methodology as primary endpoint.||1.766|0.215|0.3674
70904312|NCT01225822|141297136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.809||||0.5663||95.0|0.393|1.668|||Regression, Logistic|||BIBR 1048 50 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.||1.668|0.393|0.5663
70904313|NCT01225822|141297136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.556||||0.1678||95.0|0.242|1.28|||Regression, Logistic|||BIBR 1048 150 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.||1.28|0.242|0.1678
70904314|NCT01225822|141297136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.269||||0.0113||95.0|0.097|0.743|||Regression, Logistic|||BIBR 1048 225 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.||0.743|0.097|0.0113
70904315|NCT01225822|141297137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|15.818||||0.0077||95.0|2.077|120.474|||Regression, Logistic|||BIBR 1048 225 mg bid vs. BIBR 1048 50 mg bid, same methodology as for primary endpoint||120.474|2.077|0.0077
70904316|NCT01225822|141297137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.907||||0.0062||95.0|2.229|128.238|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 50 mg bid, same methodology as for primary endpoint||128.238|2.229|0.0062
70966796|NCT04272892|141440105|SUPERIORITY||Mean Difference (Final Values)|1.61||||0.054|TWO_SIDED|95.0|-0.03|3.25|||ANCOVA|ANCOVA of GAD7 post-intervention, with baseline as covariate, effect of group||||3.25|-0.03|0.054
70966797|NCT04272892|141440106|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.229|TWO_SIDED|95.0|-0.7|2.87|||ANCOVA|ANCOVA of GAD7 at 8 week follow up, with baseline as covariate, effect of group||||2.87|-.70|0.229
70904317|NCT01225822|141297137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.136||||0.7192||95.0|0.567|2.276|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 300 mg qd, same methodology as for primary endpoint||2.276|0.567|0.7192
70904318|NCT01225822|141297137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.121||||0.0472||95.0|0.015|0.974|||Regression, Logistic|||BIBR 1048 50 mg bid vs. Enoxaparin 40 mg qd, same methodology as for primary endpoint||0.974|0.015|0.0472
70904319|NCT01225822|141297137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.049||||0.1043||95.0|0.862|4.868|||Regression, Logistic|||BIBR 1048 150 mg bid vs. Enoxaparin 40 mg qd, same methodology as for primary endpoint||4.868|0.862|0.1043
70904320|NCT01225822|141297137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.917||||0.1448||95.0|0.799|4.597|||Regression, Logistic|||BIBR 1048 225 mg bid vs. Enoxaparin 40 mg qd, same methodology as for primary endpoint||4.597|0.799|0.1448
70904321|NCT01225822|141297139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.871||||0.0063|TWO_SIDED|95.0|2.221|128.142|||Regression, Logistic|||||128.142|2.221|0.0063
70904322|NCT01225822|141297139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|22.338||||0.0025|TWO_SIDED|95.0|2.983|167.268|||Regression, Logistic|||||167.268|2.983|0.0025
70904323|NCT01225822|141297139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.919||||0.7973|TWO_SIDED|95.0|0.483|1.75|||Regression, Logistic|||||1.750|0.483|0.7973
70904324|NCT01225822|141297139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.068||||0.0097|TWO_SIDED|95.0|0.009|0.522|||Regression, Logistic|||||0.522|0.009|0.0097
70904325|NCT01225822|141297139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.522||||0.2375|TWO_SIDED|95.0|0.758|3.058|||Regression, Logistic|||||3.058|0.758|0.2375
70904326|NCT01225822|141297139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.7104|TWO_SIDED|95.0|0.55|2.403|||Regression, Logistic|||||2.403|0.550|0.7104
70904327|NCT01407354|141297148|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Chi-squared, Corrected|||||||0.05
70904328|NCT01407354|141297148|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|threshold p value for statistical significance=0.05||||||0.024
70904329|NCT00930943|141297149|SUPERIORITY||||||<|0.001||||||repeated-measure ANOVA tested time-post-dose effect for Rapid Visual Information Processing (RVP): sensitivity (A')|ANOVA|||The a priori sample-size estimation for a power of 80% with alpha = 0.05 was based on the primary-outcome measure, the rapid visual information processing (RVP) sensitivity (A') score. Using a repeated-measure ANOVA for the food effect (fed versus fasting) and assuming an effect size of f =0.26 generated a required sample size of 32 participants. However, only 30 subjects completed both testing visits, generating a power of 78.2%.|(F\[1,28\] = 22.71; η2 = 0.45)|||<0.001
70904330|NCT00930943|141297149|SUPERIORITY|||||||0.01||||||repeated-measure ANOVA tested food x time-post-dose effect for Rapid Visual Information Processing (RVP): sensitivity (A')|ANOVA||||F\[1,28\]=6.88; η2=0.20|||0.01
70904331|NCT00930943|141297149|SUPERIORITY||||||>|0.05||||||repeated-measure ANOVA testing food effect for Rapid Visual Information Processing (RVP): sensitivity (A')|ANOVA|||||||>0.05
70904332|NCT00930943|141297150|SUPERIORITY||||||<|0.001||||||Repeated-measure ANOVA testing time-post-dose effect for Rapid Visual Information Processing (RVP): response latency|ANOVA||||(F\[1,28\] = 14.05; η2 = 0.33)|||<0.001
70904333|NCT00930943|141297150|SUPERIORITY||||||>|0.05||||||"repeated-measure ANOVA testing food and food x time post dose effect for Rapid Visual Information Processing (RVP): response latency"|ANOVA|||||||>0.05
70904334|NCT00930943|141297151|SUPERIORITY||||||>|0.05||||||"repeated-measure ANOVA testing food, time-post-dose, and food x time-post-dose effect for SRM percentage of correct hits"|ANOVA|||||||>0.05
70904335|NCT00930943|141297152|SUPERIORITY||||||<|0.001||||||Repeated-measure ANOVA testing time-post-dose effect for Spatial Recognition Memory (SRM) response latency|ANOVA||||(F\[1,28\] = 31.26; η2 = 0.53)|||<0.001
70904336|NCT00930943|141297152|SUPERIORITY||||||>|0.05||||||"repeated-measure ANOVA testing food and food x time-post-dose effect for SRM response latency"|ANOVA|||||||>0.05
70904337|NCT00930943|141297153|SUPERIORITY||||||>|0.05||||||"repeated-measure ANOVA testing food, time-post-dose, and food x time-post-dose effect for SWM total errors"|ANOVA|||||||>0.05
70904338|NCT00930943|141297154|SUPERIORITY||||||>|0.05||||||"repeated-measure ANOVA testing food, time-post-dose, and food x time-post-dose effect for SWM strategy score"|ANOVA|||||||>0.05
70904339|NCT00612534|141297189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.26|STANDARD_ERROR_OF_MEAN|7.83||0.194||95.0|-5.32|25.83|||ANCOVA|||||25.83|-5.32|0.194
70904340|NCT00612534|141297189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.67|STANDARD_ERROR_OF_MEAN|7.77||0.268|TWO_SIDED|95.0|-6.78|24.11|||ANCOVA|||||24.11|-6.78|0.268
70904341|NCT00612534|141297189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.05|STANDARD_ERROR_OF_MEAN|8.3||0.018|TWO_SIDED|95.0|3.54|36.56|||ANCOVA|||||36.56|3.54|0.018
70904342|NCT01008475|141297211|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.13|||||TWO_SIDED|95.0|0.78|1.64||||||||1.64|0.78|
70904343|NCT01008475|141297211|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.11|||||TWO_SIDED|95.0|0.77|1.61||||||||1.61|0.77|
70904344|NCT01008475|141297212|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83|||||TWO_SIDED|95.0|0.54|1.28||||||||1.28|0.54|
70904345|NCT01008475|141297212|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8|||||TWO_SIDED|95.0|0.52|1.25||||||||1.25|0.52|
70904346|NCT01008475|141297213|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.11|||||TWO_SIDED|95.0|0.75|1.65||||||||1.65|0.75|
70904347|NCT01008475|141297213|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.11|||||TWO_SIDED|95.0|0.75|1.65||||||||1.65|0.75|
70904348|NCT01008475|141297215|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.95|||||TWO_SIDED|95.0|0.67|1.34||||||||1.34|0.67|
70904349|NCT01008475|141297215|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.05|||||TWO_SIDED|95.0|0.74|1.48||||||||1.48|0.74|
70904350|NCT03556358|141297220|EQUIVALENCE|"Two one-sided hypothesis tests were performed for pCR in order to show that TX05 is equivalent to Herceptin:~* TEST 1: H0a: θ1 / θ2 \> 1.325 vs. H1a: θ1 / θ2 \< 1.325~* TEST 2: H0b: θ1 / θ2 \< 0.755 vs. H1b: θ1 / θ2 \> 0.755~Where θ1 is the proportion of pCR for subjects randomized to TX05 group, θ2 is the proportion of pCR for subjects randomized to Herceptin. Equivalence was concluded if the 95% CI of the risk ratio is completely contained within the pre-defined interval \[0.755, 1.325\]."|Risk Ratio (RR)|1.0783|||||TWO_SIDED|95.0|0.9185|1.2659||||||||1.2659|0.9185|
70966798|NCT04272892|141440107|SUPERIORITY||Mean Difference (Final Values)|-1.39||||0.502|TWO_SIDED|95.0|-5.51|2.73|||ANCOVA|ANCOVA of SIS index at post-intervention, with baseline as covariate, effect of group||||2.73|-5.51|0.502
70966799|NCT04272892|141440108|SUPERIORITY||Mean Difference (Final Values)|0.183||||0.924|TWO_SIDED|95.0|-3.63|4.0|||ANCOVA|ANCOVA of SIS index at 8 week follow up, with baseline as covariate, effect of group||||4.0|-3.63|0.924
70966800|NCT03697720|141440134|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was .05|t-test, 2 sided|Paired t-test||Paired t-tests were used to compare worst menstrual pain rating across diary day (0-10 numeric rating scale) from baseline and at 6-8 maths followup.||||<0.0001
70966801|NCT03697720|141440135|SUPERIORITY|||||||0.119|||||||t-test, 2 sided|paired t-test||||||.119
70966802|NCT01901575|141440171|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.65|STANDARD_ERROR_OF_MEAN|0.75||0.05|TWO_SIDED|0.15|0.65|0.8|||Fisher Exact|||"null hypothesis:~Remifentanil IVPCA sedation in patients undergoing ablation of the idiopathic ventricular tachycardia does not cause suppression of PVC's"||0.8|0.65|0.05
70966803|NCT01940471|141440190|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sample sizes of 288 and 576 participants in the TDF and TAF groups, respectively, were planned to give 84% power to rule out the noninferiority margin of 10% at a 1-sided significance level of 0.025. This sample size based on the assumption that the expected difference (TAF - TDF) in the proportion of participants with HBV DNA \< 29 IU/mL was 0 and the proportion of participants with HBV DNA \< 29 IU/mL in the TDF group was 69%. Missing data were treated as not achieving the primary endpoint.|Difference in proportions|-3.6|||||TWO_SIDED|95.0|-9.8|2.6|||||Difference in the proportion between treatment groups and its 95% CI were calculated based on the Mantel-Haenszel (MH) proportions adjusted by baseline HBV DNA categories and oral antiviral treatment status strata.|The null hypothesis was that the TAF group is at least 10% worse than the TDF group with respect to the proportion of participants with HBV DNA \< 29 IU/mL at Week 48. The alternative hypothesis was that the TAF group is less than 10% worse than the TDF group with respect to the proportion of participants with HBV DNA \< 29 IU/mL at Week 48. Noninferiority was assessed using a 95% confidence interval (CI) approach, with a noninferiority margin of 10%.||2.6|-9.8|
70966804|NCT03462719|141440196|SUPERIORITY||Hazard Ratio (HR)|0.216|||<|0.0001|TWO_SIDED|95.0|0.131|0.357|||Log Rank|||||0.357|0.131|<0.0001
70966805|NCT03740165|141440211|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0002|TWO_SIDED|95.0|0.53|0.83||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||0.83|0.53|0.0002
70966806|NCT03740165|141440211|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.3339|TWO_SIDED|95.0|0.77|1.19||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.19|0.77|0.3339
70966807|NCT03740165|141440212|SUPERIORITY||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.61|0.84||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||0.84|0.61|<0.0001
70966808|NCT03740165|141440212|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.5527|TWO_SIDED|95.0|0.87|1.18||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.18|0.87|0.5527
70966809|NCT03740165|141440213|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.4314|TWO_SIDED|95.0|0.75|1.27||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.27|0.75|0.4314
70966810|NCT03740165|141440213|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.3107|TWO_SIDED|95.0|0.72|1.22||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.22|0.72|0.3107
70966811|NCT03740165|141440214|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.6716|TWO_SIDED|95.0|0.87|1.25||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.25|0.87|0.6716
70966812|NCT03740165|141440214|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.7448|TWO_SIDED|95.0|0.89|1.27||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.27|0.89|0.7448
70966813|NCT03740165|141440215|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0012|TWO_SIDED|95.0|0.5|0.86||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||0.86|0.50|0.0012
70966814|NCT03740165|141440215|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.4366|TWO_SIDED|95.0|0.75|1.27||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.27|0.75|0.4366
70966815|NCT03740165|141440216|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0008|TWO_SIDED|95.0|0.61|0.89||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||0.89|0.61|0.0008
70966816|NCT03740165|141440216|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7174|TWO_SIDED|95.0|0.88|1.27||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.27|0.88|0.7174
70966817|NCT03740165|141440217|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0228|TWO_SIDED|95.0|0.62|1.0||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.00|0.62|0.0228
70966818|NCT03740165|141440217|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.3935|TWO_SIDED|95.0|0.77|1.22||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.22|0.77|0.3935
70966819|NCT03740165|141440218|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.0573|TWO_SIDED|95.0|0.74|1.03||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.03|0.74|0.0573
70966820|NCT03740165|141440218|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7234|TWO_SIDED|95.0|0.89|1.23||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.23|0.89|0.7234
70966821|NCT03740165|141440219|SUPERIORITY||Difference in Least Squares Means (LSM)|0.26||||0.8481|TWO_SIDED|95.0|-2.44|2.97|||t-test, 2 sided||Based on cLDA model with scores as response variable; covariates for treatment by time interaction and stratification factors (debulking surgery \[planned interval vs R0 following primary vs R1 following primary\], bevacizumab use, and PD-L1 CPS)|||2.97|-2.44|0.8481
70966822|NCT03740165|141440219|SUPERIORITY||Difference in LS Means|-1.1||||0.4335|TWO_SIDED|95.0|-3.87|1.66|||t-test, 2 sided||Based on cLDA model with scores as response variable; covariates for treatment by time interaction and stratification factors (debulking surgery \[planned interval vs R0 following primary vs R1 following primary\], bevacizumab use, and PD-L1 CPS)|||1.66|-3.87|0.4335
70966823|NCT03740165|141440220|SUPERIORITY||Difference in Least Squares Means (LSM)|0.14||||0.9024|TWO_SIDED|95.0|-2.15|2.44|||t-test, 2 sided||Based on cLDA model with scores as response variable; covariates for treatment by time interaction and stratification factors (debulking surgery \[planned interval vs R0 following primary vs R1 following primary\], bevacizumab use, and PD-L1 CPS)|||2.44|-2.15|0.9024
70966824|NCT03740165|141440220|SUPERIORITY||Difference in Least Squares Means (LSM)|-0.08||||0.9478|TWO_SIDED|95.0|-2.47|2.31|||t-test, 2 sided||Based on cLDA model with scores as response variable; covariates for treatment by time interaction and stratification factors (debulking surgery \[planned interval vs R0 following primary vs R1 following primary\], bevacizumab use, and PD-L1 CPS)|||2.31|-2.47|0.9478
70966825|NCT03740165|141440221|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.2644|TWO_SIDED|95.0|0.73|1.17||One-sided p-value based on log-rank test stratified by surgery (planned interval debulking versus R0 following primary debulking versus R1 following primary debulking), bevacizumab use (yes versus no), and PD-L1 status (CPS\<10 vs CPS≥10).|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by surgery (planned interval vs R0 following primary vs R1 following primary debulking), bevacizumab use (Yes vs No), PD-L1 status (CPS\<10 vs CPS≥10)|||1.17|0.73|0.2644
70966826|NCT03740165|141440221|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.1953|TWO_SIDED|95.0|0.71|1.14||One-sided p-value based on log-rank test stratified by surgery (planned interval debulking versus R0 following primary debulking versus R1 following primary debulking), bevacizumab use (yes versus no), and PD-L1 status (CPS\<10 vs CPS≥10).|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by surgery (planned interval vs R0 following primary vs R1 following primary debulking), bevacizumab use (Yes vs No), PD-L1 status (CPS\<10 vs CPS≥10)|||1.14|0.71|0.1953
70966827|NCT03740165|141440222|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.5188|TWO_SIDED|95.0|0.77|1.3||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.30|0.77|0.5188
70966828|NCT03740165|141440222|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.5091|TWO_SIDED|95.0|0.77|1.3||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.30|0.77|0.5091
70966829|NCT03740165|141440223|SUPERIORITY||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.59|0.8||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||0.80|0.59|<0.0001
70966830|NCT03740165|141440223|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.1206|TWO_SIDED|95.0|0.79|1.06||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.06|0.79|0.1206
70966831|NCT03740165|141440224|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.0853||95.0|0.76|1.05||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.05|0.76|0.0853
70966832|NCT03740165|141440224|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7165||95.0|0.89|1.23||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.23|0.89|0.7165
70966833|NCT03740165|141440225|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.0442||95.0|0.76|1.02||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.02|0.76|0.0442
70966834|NCT03740165|141440225|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.9565||95.0|0.98|1.31||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.31|0.98|0.9565
70966835|NCT03740165|141440226|SUPERIORITY||Difference in Percentage|3.7||||0.0318|TWO_SIDED|95.0|-0.3|7.3||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|t-test, 1 sided||Based on Miettinen \& Nurminen method stratified by bevacizumab use (Yes vs No) and PD-L1 CPS (\<10 vs ≥10)|||7.3|-0.3|0.0318
70966836|NCT02044133|141440229|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
70966837|NCT05318937|141440230|SUPERIORITY||Difference in LS Means|0.0|STANDARD_ERROR_OF_MEAN|2.07||0.9934|TWO_SIDED|95.0|-4.13|4.09||The p-value was obtained using a MMRM model which included treatment, visit, treatment-by-visit interaction as categorical covariates, and WAIS-IV at baseline as continuous covariates.|MMRM||Difference was calculated as SAGE-718 - placebo.|||4.09|-4.13|0.9934
70966838|NCT05314517|141440244|OTHER||Stratified Common Risk Difference|14.1||||0.1244|TWO_SIDED|90.0|-1.0|29.2|||Cochran-Mantel-Haenszel|||||29.2|-1.0|0.1244
70966839|NCT04490018|141440274|NON_INFERIORITY|The two-sided 95 percent (%) confidence interval (CI) was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 95% CI of the percentage difference between compared groups was greater than (\>) -10%.|Difference in Percentage|4.98|||||TWO_SIDED|95.0|0.06|10.36||||||Serogroup A||10.36|0.06|
70966840|NCT04490018|141440274|NON_INFERIORITY|The two-sided 95% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 95% CI of the percentage difference between compared groups was greater \> -10%.|Difference in Percentage|4.97|||||TWO_SIDED|95.0|1.58|9.5||||||Serogroup C||9.50|1.58|
70966841|NCT04490018|141440274|NON_INFERIORITY|The two-sided 95% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 95% CI of the percentage difference between compared groups was greater \> -10%.|Difference in Percentage|1.24|||||TWO_SIDED|95.0|-1.28|4.42||||||Serogroup W||4.42|-1.28|
70966842|NCT04490018|141440274|NON_INFERIORITY|The two-sided 95% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 95% CI of the percentage difference between compared groups was greater \> -10%.|Difference in Percentage|1.24|||||TWO_SIDED|95.0|-1.88|4.77||||||Serogroup Y||4.77|-1.88|
70966843|NCT04714073|141440302|OTHER||Ratio of geometric means (%)|218.81|||||TWO_SIDED|90.0|194.06|246.72|||||"The estimated parameter was the adjusted geometric mean ratio (%): BI 706321 + Itraconazole (Test Treatment(T))/BI 706321 alone (Reference Treatment (R)).~Intra-individual geometric coefficient of variation (gCV) \[%\] = 18.1."|The statistical model used for the analysis of the primary PK endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subject' was considered as random, whereas 'treatment' was considered as fixed.||246.72|194.06|
70966844|NCT04714073|141440303|OTHER||Ratio of geometric means (%)|156.29|||||TWO_SIDED|90.0|135.04|180.89|||||"The estimated parameter was the adjusted geometric mean ratio (%): BI 706321 + Itraconazole (Test Treatment(T))/BI 706321 alone (Reference Treatment (R)).~Intra-individual geometric coefficient of variation (gCV) \[%\] = 22.1."|The statistical model used for the analysis of the primary PK endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subject' was considered as random, whereas 'treatment' was considered as fixed.||180.89|135.04|
70966845|NCT04714073|141440304|OTHER||Ratio of geometric means (%)|223.12|||||TWO_SIDED|90.0|198.61|250.66|||||"The estimated parameter was the adjusted geometric mean ratio (%): BI 706321 + Itraconazole (Test Treatment(T))/BI 706321 alone (Reference Treatment (R)).~Intra-individual geometric coefficient of variation (gCV) \[%\] = 17.5."|The statistical model used for the analysis of the primary PK endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subject' was considered as random, whereas 'treatment' was considered as fixed.||250.66|198.61|
70966846|NCT00282295|141440305|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was greater than (\>) the pre-defined limit of -10%.|Difference|2.18|||||TWO_SIDED|95.0|0.79|4.17||||||The non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to the percentage of subjects with anti-diphtheria toxoid (anti-D) antibody concentrations equal to or greater than (≥) 1.0 IU/mL one month after vaccination.||4.17|0.79|
70966847|NCT00282295|141440305|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority objective was demonstrated if the lower limit was greater than (\>) the pre-defined limit of -10%.|Difference|0.02|||||TWO_SIDED|95.0|-1.4|1.48||||||Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared toBoostrix® vaccine administered alone at Month 0 with respect to the percentage of subjects with anti-tetanus toxoid (anti-T) antibody concentrations equal to or greater than (≥) 1.0 IU/mL one month after vaccination.||1.48|-1.4|
70966848|NCT00282295|141440306|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was greater than (\>) the pre-defined limit of 0.67|Adjusted GMC ratio|0.93|||||TWO_SIDED|95.0|0.84|1.03||||||Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to anti-pertussis toxoid (anti-PT) geometric mean antibody concentrations (GMCs) one month after vaccination.||1.03|0.84|
70904351|NCT04195880|141297222|SUPERIORITY||||||<|0.05|TWO_SIDED|5.0|||||negative-binomial regression coefficient|||We assumed the average monthly pre-intervention hospitalization rates of intervention and control CLCs were equal, so only average monthly post-intervention hospitalization rates might diverge. Each CLC had its own start month and contributed 18 months pre-intervention and 18 months post-intervention. Hospitalizations rates were modeled using a multilevel negative-binomial regression because it allows for over-dispersion, which is commonly observed with medical events such as a count.||||<.05
70904352|NCT01351025|141297233|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94|TWO_SIDED|||||Two-sided p-values of \< 0.05 without adjustments for multiple testing were considered statistically significant.|Wilcoxon (Mann-Whitney)|Exact Wilcoxon rank sum test was used||The null hypothesis is that there is no difference between arm A and arm B in the differences of the changes (\[week 44 - week 24\] - \[week 20 - baseline\]) in log10 IL-6||||0.94
70904353|NCT01351025|141297234|SUPERIORITY_OR_OTHER_LEGACY|||||||0.495|TWO_SIDED|||||Two-sided p-values of \< 0.05 without adjustments for multiple testing were considered statistically significant.|Wilcoxon (Mann-Whitney)|exact Wilcoxon rank sun test was used||The null hypothesis is that there is no difference between arm A and arm B in the differences of the changes (\[week 44 - week 24\] - \[week 20 - baseline\]) in CD4+ T-cell activation percent (% CD38+/DR+ of CD4)||||0.495
70904354|NCT01351025|141297235|SUPERIORITY_OR_OTHER_LEGACY|||||||0.704|TWO_SIDED|||||Two-sided p-values of \< 0.05 without adjustments for multiple testing were considered statistically significant.|Wilcoxon (Mann-Whitney)|exact Wilcoxon rank sum test was used||The null hypothesis is that there is no difference between arm A and arm B in the differences of the changes (\[week 44 - week 24\] - \[week 20 - baseline\]) in log10 D-dimer||||0.704
70904355|NCT01351025|141297236|SUPERIORITY_OR_OTHER_LEGACY|||||||0.508|TWO_SIDED|||||Two-sided p-values of \< 0.05 without adjustments for multiple testing were considered statistically significant.|Wilcoxon (Mann-Whitney)|Exact Wilcoxon rank sum test was used||The null hypothesis is that there is no difference between arm A and arm B in the differences of the changes (\[week 44 - week 24\] - \[week 20 - baseline\]) in CD8+ T-cell activation percent (% CD38+/DR+ of CD8+)||||0.508
70904356|NCT03573908|141297249|SUPERIORITY||Least squares (LS) mean difference|-0.715|||<|0.0001|TWO_SIDED|95.0|-0.998|-0.433|||MMRM||Least squares (LS) mean difference (linaclotide - placebo)|The overall family-wise Type I error rate for the primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.433|-0.998|< 0.0001
70904357|NCT03573908|141297250|SUPERIORITY||Hodges-Lehman Estimated Median Threshold|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.88|-0.35|||Wilcoxon Rank Sum Test|P-value comparing change from baseline distributions by treatment using the Wilcoxon rank sum test 2-sided.|95% confidence interval (CI) for Hodges-Lehmann estimated median threshold was generated by Moses confidence limits method.|The overall family-wise Type I error rate for the primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.35|-0.88|< 0.0001
70904358|NCT03573908|141297251|SUPERIORITY||Difference in Responder Rate|17.1|||||TWO_SIDED|95.0|9.9|24.4|||||95% confidence intervals for difference in responder rate are obtained using the normal approximation to the binomial distribution.|||24.4|9.9|
70966849|NCT00282295|141440306|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was \> the pre-defined limit of 0.67|Adjusted GMC ratio|0.76|||||TWO_SIDED|95.0|0.69|0.84||||||Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to anti-filamentous hemagglutinin (anti-FHA) GMCs one month after vaccination.||0.84|0.69|
70966850|NCT00282295|141440306|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was \> the pre-defined limit of 0.67|Adjusted GMC ratio|0.63|||||TWO_SIDED|95.0|0.54|0.72||||||To demonstrate the non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to anti-pertactin (anti-PRN) GMCs one month after vaccination.||0.72|0.54|
70966851|NCT00282295|141440307|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was \> the pre-defined limit of -10%.|Difference in booster response rate|-4.38|||||TWO_SIDED|95.0|-9.91|1.15||||||Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to a booster response to PT one month after vaccination.||1.15|-9.91|
70966852|NCT00282295|141440307|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was \> the pre-defined limit of -10%.|Difference in booster response rate|-3.39|||||TWO_SIDED|95.0|-7.03|0.15||||||Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to a booster response to FHA one month after vaccination.||0.15|-7.03|
70966853|NCT00282295|141440307|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was \> the pre-defined limit of -10%.|Difference in booster response rate|-1.96|||||TWO_SIDED|95.0|-5.25|-1.25||||||To demonstrate the non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to a booster response to PRN one month after vaccination.||-1.25|-5.25|
70966854|NCT00282295|141440308|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was greater than the pre-defined limit of -10%.|Difference in vaccine response rate|-0.21|||||TWO_SIDED|95.0|-4.85|4.43||||||Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccinecompared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine responseto meningococcal serogroup A one month after vaccination.||4.43|-4.85|
70966855|NCT00282295|141440308|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was greater than the pre-defined limit of -10%.|Difference in vaccine response rate|1.69|||||TWO_SIDED|95.0|-1.69|5.16||||||Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccine compared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine responseto meningococcal serogroup C one month after vaccination.||5.16|-1.69|
70966856|NCT00282295|141440308|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was greater than the pre-defined limit of -10%.|Difference in vaccine response rate|1.82||||||95.0|-2.58|6.25||||||Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccine compared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine response to meningococcal serogroup Y one month after vaccination.||6.25|-2.58|
70966857|NCT00282295|141440308|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was greater than the pre-defined limit of -10%.|Difference in vaccine response rate|3.56|||||TWO_SIDED|95.0|0.96|6.45||||||Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccine compared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine response to meningococcal serogroup W-135 one month after vaccination||6.45|0.96|
70966858|NCT01401842|141440335|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Mixed Models Analysis|||For the primary hypothesis, differences at follow-up between the two groups on lumbar extension muscular strength (Nm) were analyzed using linear mixed-effects regression models, accounting for the effects of cluster (platoon) and adjusting for baseline measures. The linear mixed-effects model treats the data as two levels (level 1 for individuals, level 2 for clusters), while also taking into account between-cluster variation.||||0.001
70966859|NCT01401842|141440336|SUPERIORITY_OR_OTHER|||||||0.871|TWO_SIDED||||||Mixed Models Analysis|||For the primary hypothesis, differences at follow-up between the two groups on core muscular endurance (seconds) were analyzed using linear mixed-effects regression models, accounting for the effects of cluster (platoon) and adjusting for baseline measures. The linear mixed-effects model treats the data as two levels (level 1 for individuals, level 2 for clusters), while also taking into account between-cluster variation.||||0.871
70966860|NCT01401842|141440337|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Mixed Models Analysis|||For the primary hypothesis, differences at follow-up between the two groups on core muscular endurance (seconds) were analyzed using linear mixed-effects regression models, accounting for the effects of cluster (platoon) and adjusting for baseline measures. The linear mixed-effects model treats the data as two levels (level 1 for individuals, level 2 for clusters), while also taking into account between-cluster variation.||||0.021
70966861|NCT00121108|141440346|SUPERIORITY||Relative risk|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.21|||Fisher Exact|||||0.21|0.08|<0.001
70966862|NCT01380379|141440357|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|Single group comparison pre-post change score, compared to a value of 0 (no change)||||||<.01
70966863|NCT01380379|141440358|SUPERIORITY_OR_OTHER||||||<|0.04|||||||t-test, 2 sided|||||||<.04
70966864|NCT02971631|141440359|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|Paired analysis||||||0.008
70966865|NCT02971631|141440360|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|Paired analysis||||||0.03
70966866|NCT02971631|141440361|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|Paired analysis||For meal consumption rate||||0.79
70966867|NCT02971631|141440363|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|Paired analysis||Baseline||||0.20
70966868|NCT02971631|141440363|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|Paired analysis||Post-OGTT||||0.58
70966869|NCT02971631|141440363|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|Paired analysis||Pre-meal||||0.39
70966870|NCT02971631|141440363|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|Paired analysis||Post-meal||||0.20
70966871|NCT02971631|141440364|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|Paired analysis||Baseline||||0.26
70966872|NCT02971631|141440364|SUPERIORITY|||||||0.06||||||Paired analysis|t-test, 2 sided|||Post-OGTT||||0.06
70966873|NCT02971631|141440364|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|Paired analysis||Pre-meal||||0.95
70966874|NCT02971631|141440364|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|Paired analysis||Post-meal||||0.88
70966875|NCT02971631|141440365|SUPERIORITY|||||||1|||||||Other|0 events over whole study, no statistical test appropriate||||||1
70966876|NCT02971631|141440366|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
70966877|NCT00683163|141440376|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.82|TWO_SIDED|95.0|-11.5|9.2|||t-test, 2 sided|||Mean difference in percent change from baseline (Concurrent - Sequential)||9.2|-11.5|0.82
70966878|NCT04456764|141440377|SUPERIORITY|||||||0.55||||||Test for group by time interaction.|Mixed Models Analysis|Adjusted for clustering.||||||0.55
70966879|NCT04456764|141440378|SUPERIORITY|||||||0.12||||||group x time interaction|Mixed Models Analysis|random agency and a random participant effect||||||0.12
70966880|NCT04456764|141440379|SUPERIORITY|||||||0.0986|||||||Mixed Models Analysis|Adjusted for clustering.||||||0.0986
70966881|NCT04456764|141440380|SUPERIORITY|||||||0.51||||||Group by time interaction.|Mixed Models Analysis|Adjusted for clustering.||||||0.51
70966882|NCT04456764|141440381|SUPERIORITY|||||||0.04||||||Group by time interaction.|Mixed Models Analysis|Adjusted for clustering.||||||0.04
70966883|NCT04456764|141440382|SUPERIORITY|||||||0.02||||||Group by time interaction.|Mixed Models Analysis|Adjusted for clustering.||||||0.02
70966884|NCT03496012|141440384|SUPERIORITY||Difference in Proportions|2.9|||=|0.354|TWO_SIDED|95.0|-3.1|15.0|||Fisher's Exact|||||15|-3.1|=0.354
70966885|NCT03496012|141440384|SUPERIORITY||Difference in proportions|4.6|||=|0.245|TWO_SIDED|95.0|-1.4|12.8|||Fisher's Exact|||||12.8|-1.4|=0.245
70966886|NCT03496012|141440386|SUPERIORITY||Difference in proportions|16.0|||||TWO_SIDED|95.0|5.3|32.2||||||||32.2|5.3|
70966887|NCT03496012|141440386|SUPERIORITY||Difference in proportions|12.2|||||TWO_SIDED|95.0|3.5|23.0||||||||23|3.5|
70966888|NCT03496012|141440387|SUPERIORITY||Difference in proportions|2.8|||||TWO_SIDED|95.0|-17.2|21.0||||||||21|-17.2|
70966889|NCT03496012|141440387|SUPERIORITY||Difference in proportions|15.3|||||TWO_SIDED|95.0|0.3|30.1||||||||30.1|0.3|
70966890|NCT00449670|141440428|EQUIVALENCE|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the \[0.5 ; 2\] clinical limit interval.|Adjusted GMT ratio|0.81||||||95.0|0.66|1.01|||ANCOVA|||Demonstration of the consistency of the immune response (in terms of geometric mean titer \[GMT\] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 1 and Lot 2).||1.01|0.66|
70966891|NCT00449670|141440428|EQUIVALENCE|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the \[0.5 ; 2\] clinical limit interval.|Adjusted GMT ratio|0.85|||||TWO_SIDED|95.0|0.69|1.06|||ANCOVA|||Demonstration of the consistency of the immune response (in terms of geometric mean titer \[GMT\] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 1 and Lot 3).||1.06|0.69|
70966892|NCT00449670|141440428|EQUIVALENCE|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the \[0.5 ; 2\] clinical limit interval.|Adjusted GMT ratio|0.85|||||TWO_SIDED|95.0|0.68|1.05|||ANCOVA|||Demonstration of the consistency of the immune response (in terms of geometric mean titer \[GMT\] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 1 and Lot 4).||1.05|0.68|
70966893|NCT00449670|141440428|EQUIVALENCE|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the \[0.5 ; 2\] clinical limit interval.|Adjusted GMT ratio|1.05|||||TWO_SIDED|95.0|0.85|1.3|||ANCOVA|||Demonstration of the consistency of the immune response (in terms of geometric mean titer \[GMT\] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 2 and Lot 3).||1.3|0.85|
70966894|NCT00449670|141440428|EQUIVALENCE|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the \[0.5 ; 2\] clinical limit interval.|Adjusted GMT ratio|1.04|||||TWO_SIDED|95.0|0.84|1.29|||ANCOVA|||Demonstration of the consistency of the immune response (in terms of geometric mean titer \[GMT\] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 2 and Lot 4).||1.29|0.84|
70966895|NCT00449670|141440428|EQUIVALENCE|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the \[0.5 ; 2\] clinical limit interval.|Adjusted GMT ratio|0.99|||||TWO_SIDED|95.0|0.8|1.23|||ANCOVA|||Demonstration of the consistency of the immune response (in terms of geometric mean titer \[GMT\] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 3 and Lot 4).||1.23|0.8|
70966896|NCT01251653|141440493|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|81.27|STANDARD_DEVIATION|63.3||0.4815|TWO_SIDED|90.0|44.863|147.205|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Afatinib with Gemcitabine vs. Afatinib without Gemcitabine was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||147.205|44.863|0.4815
70966897|NCT01251653|141440493|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|95.36|STANDARD_DEVIATION|15.4||0.0149|TWO_SIDED|90.0|84.139|108.077|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Afatinib with Docetaxel vs. Afatinib without Docetaxel was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||108.077|84.139|0.0149
70966898|NCT01251653|141440493|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|88.12|STANDARD_DEVIATION|9.2||0.0208|TWO_SIDED|90.0|81.778|94.964|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Afatinib with Docetaxel vs. Afatinib without Docetaxel was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||94.964|81.778|0.0208
70966899|NCT01251653|141440494|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|141.36|STANDARD_DEVIATION|14.7||0.8715|TWO_SIDED|90.0|115.848|172.495|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Afatinib with Gemcitabine vs. Afatinib without Gemcitabine was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||172.495|115.848|0.8715
70966900|NCT01251653|141440494|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|77.42|STANDARD_DEVIATION|16.8||0.6805|TWO_SIDED|90.0|68.516|87.473|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Afatinib with Docetaxel vs. Afatinib without Docetaxel was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||87.473|68.516|0.6805
70966901|NCT01251653|141440494|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|83.95|STANDARD_DEVIATION|14.3||0.2327|TWO_SIDED|90.0|74.794|94.217|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Afatinib with Docetaxel vs. Afatinib without Docetaxel was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||94.217|74.794|0.2327
70966902|NCT01251653|141440495|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|136.11|STANDARD_DEVIATION|26.3||0.7759|TWO_SIDED|90.0|112.09|165.29|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Gemcitabine with Afatinib vs. Gemcitabine without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||165.29|112.09|0.7759
70966903|NCT01251653|141440496|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|118.41|STANDARD_DEVIATION|31.6||0.3359|TWO_SIDED|90.0|94.81|147.88|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Gemcitabine with Afatinib vs. Gemcitabine without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||147.88|94.81|0.3359
70966904|NCT01251653|141440499|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|93.69|STANDARD_DEVIATION|19.5||0.0349|TWO_SIDED|90.0|81.352|107.89|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Docetaxel with Afatinib vs. Docetaxel without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||107.890|81.352|0.0349
70966905|NCT01251653|141440499|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|98.11|STANDARD_DEVIATION|30.4||0.0405|TWO_SIDED|90.0|81.053|118.76|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Docetaxel with Afatinib vs. Docetaxel without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||118.760|81.053|0.0405
70966906|NCT01251653|141440500|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|90.78|STANDARD_DEVIATION|22.8||0.0728|TWO_SIDED|90.0|78.566|104.901|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Docetaxel with Afatinib vs. Docetaxel without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||104.901|78.566|0.0728
70966907|NCT01251653|141440500|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|85.74|STANDARD_DEVIATION|48.9||0.3294|TWO_SIDED|90.0|65.561|112.138|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Docetaxel with Afatinib vs. Docetaxel without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||112.138|65.561|0.3294
70966908|NCT00847145|141440504|NON_INFERIORITY_OR_EQUIVALENCE|The specified cut-off levels for the vaccine antigen measles is ≥255 mIU/mL to be greater than -10%.|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-5.0|2.0||||||The immunogenicity in 12B12M (1a) group was considered non-inferior to that in group 12M13B15B (2a), if for the measles antigen (two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of subjects with antibody response greater than or equal to the specified cut-off level for Measles antigen was greater than -10%.||2|-5|
70966909|NCT00847145|141440504|NON_INFERIORITY_OR_EQUIVALENCE|The specified cut-off level for the vaccine antigen mumps is ≥10 Enzyme Linked Immunosorbent Assay(ELISA) Antibody (Ab) units to be greater than -10%.|Percentage group difference|0.0|||||TWO_SIDED|95.0|-5.0|5.0||||||The immunogenicity in 12B12M(1a) group was considered non-inferior to that in group 12M13B15B(2a), if for the mumps antigen (two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of subjects with antibody response greater than or equal to the specified cut-off level for Mumps antigen was greater than -10%.||5|-5|
70966910|NCT00847145|141440504|NON_INFERIORITY_OR_EQUIVALENCE|The specified cut-off level for the vaccine antigen rubella is ≥10 IU/mL to be greater than -10%.|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-4.0|1.0||||||The immunogenicity in 12B12M(1a) group was considered non-inferior to that in group 12M13B15B (2a), if for the rubella antigen(two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of subjects with antibody response greater than or equal to the specified cut-off level for rubella antigen was greater than -10%.||1|-4|
70904359|NCT03573908|141297251|SUPERIORITY||Odds Ratio (OR)|2.2|||<|0.0001|TWO_SIDED|95.0|1.55|3.12||Odds ratio, 95% CI for the Odds Ratio and p-value vs. placebo are obtained from the Cochran-Mantel-Haenszel (CMH) tests controlling for geographic region.|Cochran-Mantel-Haenszel|||The overall family-wise Type I error rate for the primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||3.12|1.55|< 0.0001
70904360|NCT03573908|141297252|SUPERIORITY||LS mean difference|-0.867|||<|0.0001|TWO_SIDED|95.0|-1.219|-0.515||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 12. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.515|-1.219|< 0.0001
70904361|NCT03573908|141297252|SUPERIORITY||LS mean difference|-0.719|||<|0.0001|TWO_SIDED|95.0|-1.062|-0.376||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 10. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.376|-1.062|< 0.0001
70904362|NCT03573908|141297252|SUPERIORITY||LS mean difference|-0.665||||0.0002|TWO_SIDED|95.0|-1.007|-0.322||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 8. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.322|-1.007|0.0002
70904363|NCT03573908|141297252|SUPERIORITY||LS mean difference|-0.831|||<|0.0001|TWO_SIDED|95.0|-1.151|-0.511||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 6. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.511|-1.151|< 0.0001
70904364|NCT03573908|141297252|SUPERIORITY||LS mean difference|-0.683|||<|0.0001|TWO_SIDED|95.0|-0.982|-0.383||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 4. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.383|-0.982|< 0.0001
70904365|NCT03573908|141297252|SUPERIORITY||LS mean difference|-0.628|||<|0.0001|TWO_SIDED|95.0|-0.888|-0.368||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 2. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.368|-0.888|< 0.0001
70904366|NCT03573908|141297252|SUPERIORITY||LS mean difference|-0.435|||<|0.0001|TWO_SIDED|95.0|-0.641|-0.228||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 1. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.228|-0.641|< 0.0001
70904367|NCT03573908|141297252|SUPERIORITY||LS mean difference|-0.683|||<|0.0001|TWO_SIDED|95.0|-0.969|-0.398||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 3. Not part of the fixed-sequence testing procedure.||-0.398|-0.969|< 0.0001
70966911|NCT00847145|141440504|NON_INFERIORITY_OR_EQUIVALENCE|The specified cut-off value for the vaccine antigen varicella is ≥1.25 gpELISA units/mL to be greater than -10%.|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-6.0|3.0||||||The immunogenicity in 12B12M(1a) group was considered non-inferior to that in group 12M13B15B (2a), if for the varicella antigen (two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of subjects with antibody response greater than or equal to the specified cut-off level for varicella antigen was greater than -10%.||3|-6|
70966912|NCT00847145|141440504|NON_INFERIORITY_OR_EQUIVALENCE|The specified cut-off level for the varicella vaccine antigen is ≥5 gp ELISA units/ml (seroprotection) to be greater than -10%.|Percentage group difference|-2.0|||||TWO_SIDED|95.0|-11.0|7.0||||||The immunogenicity in 12B12M (1a) group was considered non-inferior to that in group 12M13B15B (2), if for the varicella antigen (two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of the subjects with antibody response greater than or equal to the specified cut-off value for varicella antigen was greater than -10%.||7|-11|
70966913|NCT01798589|141440518|OTHER|Bioequivalence is assessed based on concordance between the 2 allergen using Kappa statistic|Concordance|66.7|||||TWO_SIDED|95.0|41.6|90.2||||||||90.2|41.6|
70966914|NCT01439282|141440549|SUPERIORITY_OR_OTHER_LEGACY|||||||0.108||||||1-side P value was obtained|1-sample binomial test|||||||0.1080
70966915|NCT02232802|141440554|EQUIVALENCE|Following logarithmic transformation, Cmax values were subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence.|least square mean difference ratio|99.42|||||TWO_SIDED|95.0|96.28|102.65|||||Geometric least square means are being compared.|Statistical comparison for Anti-FXa||102.65|96.28|
70966916|NCT02232802|141440554|EQUIVALENCE|Following logarithmic transformation, Cmax was subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence|least square mean difference ratio|91.55|||||TWO_SIDED|95.0|86.65|96.73|||||Geometric least square means are being compared.|Statistical comparison on Anti-FIIa||96.73|86.65|
70966917|NCT02232802|141440555|EQUIVALENCE|Following logarithmic transformation, AUC0-t values were subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence|least square mean difference ratio|102.89|||||TWO_SIDED|95.0|100.67|105.15|||||Geometric least square means are being compared.|Anti-FXa statistical comparison||105.15|100.67|
70966918|NCT02232802|141440555|EQUIVALENCE|Following logarithmic transformation, AUC0-t values were subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence.|least square mean difference ratio|92.37|||||TWO_SIDED|95.0|87.72|97.25|||||Geometric least square means are being compared.|Anti-FIIa comparison||97.25|87.72|
70966919|NCT02232802|141440556|EQUIVALENCE|Following logarithmic transformation, AUC0-inf values were subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence|least square mean ratio|104.26|||||TWO_SIDED|95.0|101.68|106.9|||||Geometric least square means are being compared.|Anti-FXA comparison||106.9|101.68|
70966920|NCT02232802|141440556|EQUIVALENCE|Following logarithmic transformation, AUC0-inf values were subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence|least square mean ratio|90.44|||||TWO_SIDED|95.0|85.38|95.8|||||Geometric least square means are being compared.|Anti-FIIa comparison||95.8|85.38|
70966921|NCT02232802|141440557|EQUIVALENCE|An assessment of tmax was performed using the Wilcoxon matched pairs test. In addition, a 95 % non-parametric CI was constructed for the median difference in tmax based on the method of Campbell and Gardner.|least square mean ratio|0.0||||0.7642|TWO_SIDED|95.0|-0.5|0.5||An assessment of tmax was performed using the Wilcoxon matched pairs test. In addition, a 95 % non-parametric CI was constructed for the median difference in tmax based on the method of Campbell and Gardner.|Wilcoxon (Mann-Whitney)||Geometric least square means are being compared.|Anti-FXa comparison||0.5|-0.5|0.7642
70966922|NCT02232802|141440557|EQUIVALENCE|An assessment of tmax was performed using the Wilcoxon matched pairs test. In addition, a 95 % non-parametric CI was constructed for the median difference in tmax based on the method of Campbell and Gardner.|least square mean ratio|0.0||||0.9464|TWO_SIDED|95.0|-0.5|0.5|||Wilcoxon (Mann-Whitney)||Geometric least square means are being compared.|Anti-FIIa comparison||0.5|-0.5|0.9464
70966923|NCT02232802|141440563|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence|Geometric least square mean ratio|103.94|||||TWO_SIDED|95.0|101.22|106.73||||||||106.73|101.22|
70966924|NCT02232802|141440564|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence.|Geometric least square mean ratio|108.59|||||TWO_SIDED|95.0|103.93|113.46||||||||113.46|103.93|
70966925|NCT02232802|141440565|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence.|Geometric least square mean ratio|102.76|||||TWO_SIDED|95.0|97.51|108.28||||||||108.28|97.51|
70966926|NCT02232802|141440566|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence|Geometric least square mean ratio|114.91|||||TWO_SIDED|95.0|102.29|129.08||||||||129.08|102.29|
70966927|NCT02232802|141440567|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence|Median Difference (Final Values)|0.0|||=|0.8554|TWO_SIDED|95.0|-0.5|0.5|||ANOVA|||||0.5|-0.5|= 0.8554
70966928|NCT02232802|141440568|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence|geometric least square mean ratio|100.86|||||TWO_SIDED|95.0|99.27|102.47||||||||102.47|99.27|
70966929|NCT02232802|141440569|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence.|geometric least square mean ratio|95.13|||||TWO_SIDED|95.0|85.7|105.6||||||||105.6|85.7|
70966930|NCT02232802|141440570|EQUIVALENCE|An assessment of tmax was performed using the Wilcoxon matched pairs test. In addition, a 95 % nonparametric CI was constructed for the median difference in tmax based on the method of Campbell and Gardner.|Median Difference (Final Values)|0.0|||=|0.6857|TWO_SIDED|95.0|-0.25|0.5|||Wilcoxon (Mann-Whitney)||Median difference is the difference between median tmax in Test IMP versus Reference IMP arms.|||0.5|-0.25|= 0.6857
70966931|NCT02232802|141440576|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence|Geometric least square mean ratio|111.39|||||TWO_SIDED|95.0|105.89|117.17||||||||117.17|105.89|
70966932|NCT02232802|141440577|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence|Geometric least square mean ratio|113.82|||||TWO_SIDED|95.0|107.47|120.53||||||||120.53|107.47|
70966933|NCT02232802|141440582|EQUIVALENCE|An assessment of tmax was performed using the Wilcoxon matched pairs test. In addition, a 95 % nonparametric CI was constructed for the median difference in tmax based on the method of Campbell and Gardner.|Median Difference (Final Values)|0.0|||=|0.9217|TWO_SIDED|95.0|-0.13|0.13|||Wilcoxon (Mann-Whitney)||Median difference is the difference between median tmax in Test IMP versus Reference IMP arms.|||0.13|-0.13|= 0.9217
70966934|NCT00885703|141440588|SUPERIORITY|||||||0.0012||||||Analysis did not adjust for multiple comparisons.|Chi-squared|||Testing discontinuation of any dose Fluconazole (pooled by treatment and dose) versus discontinuation of Ampho B (pooled). The null hypothesis is the two treatments have the same proportion of discontinuation.||||0.0012
70966935|NCT00885703|141440589|SUPERIORITY|||||||0.012|||||||Fisher Exact|||Among 4 treatment arms, comparison of three categorical groups: (CM negative, CM negative after switching treatment, and CM Positive/Died/Lost to Follow-up) at week 10. The null hypothesis is the 4 treatment arms have no differences at week 10.||||0.012
70966936|NCT00885703|141440590|SUPERIORITY|||||||0.019|||||||Kruskal-Wallis|||Comparison of change in quantitative CSF culture among 4 treatment arms. The null hypothesis is the 4 treatment arms have the same change in CSF culture from entry to week 2.||||0.019
70966937|NCT00885703|141440591|SUPERIORITY|||||||0.0894||||||Analysis did not adjust for multiple comparisons.|Log Rank|||Comparison of survival from entry to week 24 between Fluconazole 1200mg arm and Ampho B arm. The null hypothesis is there is no difference in survival between these two arms.||||0.0894
70966938|NCT00885703|141440591|SUPERIORITY|||||||0.4828||||||Analysis did not adjust for multiple comparisons.|Log Rank|||Comparison of survival from entry to week 24 between Fluconazole 1600mg arm and Ampho B arm. The null hypothesis is there is no difference in survival between these two arms.||||0.4828
70966939|NCT00885703|141440591|SUPERIORITY|||||||0.1766||||||Analysis did not adjust for multiple comparisons.|Log Rank|||Comparison of survival from entry to week 24 between Fluconazole 2000mg arm and Ampho B arm. The null hypothesis is there is no difference in survival between these two arms.||||0.1766
70966940|NCT04096274|141440615|SUPERIORITY|||||||0.014|||||||Mixed Models Analysis|||||||.014
70966941|NCT04096274|141440616|SUPERIORITY|||||||0.023|||||||Mixed Models Analysis|||||||.023
70966942|NCT04096274|141440617|SUPERIORITY|||||||0.188|||||||Mixed Models Analysis|||||||.188
70966943|NCT04096274|141440618|SUPERIORITY|||||||0.782|||||||Mixed Models Analysis|||||||.782
70966944|NCT03600142|141440626|NON_INFERIORITY|For WLHIV (n=55), chi-square tests were used to assess differences between conditions in the proportion of participants who were retained in HIV care at 3 months post enrollment.||||||0.963|||||||Chi-squared|||We were aware that our resources of time and funding would not be sufficient to detect a significant difference in the HIV care outcome, and that we would only be able to detect observational signals of impact. We aimed for a minimum of 50 WLHIV, which is considered an adequate sample to assess feasibility and acceptability in a pilot intervention study. Given an estimated 5% HIV prevalence among women presenting for ANC, this required us to enroll 1000 female participants.||||0.963
70966945|NCT01180478|141440632|SUPERIORITY_OR_OTHER|||||||0.585|||||||Log Rank|||The expected recurrence rate in the WL-assisted TURBT group was 35%.14 To detect a clinically relevant difference in recurrence detection rates ≥10% at a 5% significance level and a power of 80%, the required sample size per treatment was calculated to be 329 patients (658 patients in total).||||0.585
70966946|NCT01180478|141440633|SUPERIORITY_OR_OTHER|||||||0.742|||||||Chi-squared|||||||0.742
70966947|NCT01180478|141440634|SUPERIORITY_OR_OTHER|||||||0.17|||||||Fisher Exact|The analysis was performed by using the Fisher exact test, because the criteria for using the Chi square test were not met.||The statistical analyses refers to comparison of the different 8 categories (one variable) mentioned of the Clavien grading of perioperative complications between Narrow Band Imaging and White Light Trans Urethral Resection.||||0.170
70966948|NCT01180478|141440635|SUPERIORITY_OR_OTHER|||||||0.311|||||||Chi-squared|||Comparison of the numbers in 'Bleeding' between NBI and WL||||0.311
70966949|NCT01180478|141440635|SUPERIORITY_OR_OTHER|||||||0.666|||||||Chi-squared|||Comparison of the numbers in 'Fever' between NBI and WL||||0.666
70966950|NCT01180478|141440635|SUPERIORITY_OR_OTHER|||||||0.569|||||||Chi-squared|||Comparison in the number of 'UTI' between NBI and WL||||0.569
70966951|NCT01180478|141440635|SUPERIORITY_OR_OTHER|||||||0.111|||||||Chi-squared|||Comparison in the number of 'Bladder cramps' between NBI and WL||||0.111
70966952|NCT01180478|141440635|SUPERIORITY_OR_OTHER|||||||||||||||||Comparison in the number of 'DVT' between NBI and WL|Non of the participants/patients had DVT. Therefore, the p-value is not available|||
70966953|NCT01180478|141440635|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||Comparison in the number of 'CVA/TIA' between NBI and WL||||0.500
70966954|NCT01180478|141440635|SUPERIORITY_OR_OTHER|||||||||||||||||Comparison in the number of 'Lung embolism' between NBI and WL|Non of the participants/patients had a lung embolism. Therefore, no p-value was available|||
70966955|NCT01180478|141440635|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||Comparison in the number of 'Sepsis' between NBI and WL||||0.500
70966956|NCT01180478|141440635|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Comparison in the number of 'Acute Abdomen' between NBI and WL||||1.000
70966957|NCT01180478|141440635|SUPERIORITY_OR_OTHER|||||||0.17|||||||Chi-squared|||Comparison in the number of 'Other perioperative complication' between NBI and WL||||0.170
70966958|NCT01180478|141440636|SUPERIORITY_OR_OTHER|||||||0.553|TWO_SIDED||||||Chi-squared|||||||0.553
70966959|NCT02807480|141440637|OTHER|Correlation between conflict approach behavior and GAD-7 scores at baseline|Pearson correlation|0.23||||0.088|TWO_SIDED||||||Pearson correlation|||||||.088
70966960|NCT02807480|141440637|OTHER||Pearson correlation|-0.2||||0.134|TWO_SIDED||||||Pearson correlation|||Correlation of baseline response time during conflict with baseline GAD-7 scores.||||.134
70966961|NCT02807480|141440637|OTHER||Pearson correlation|0.12||||0.032|TWO_SIDED||||||Pearson correlation|||Correlation of baseline striatum response to points (reward) with baseline GAD-7 scores.||||.032
70966962|NCT02807480|141440637|OTHER||Pearson correlation|-0.12||||0.375|TWO_SIDED||||||Pearson correlation|||Correlation of baseline right amygdala activity during negative images with baseline GAD7 scores||||0.375
70966963|NCT02807480|141440637|OTHER||Pearson correlation|0.06||||0.651|TWO_SIDED||||||Pearson correlation|||Correlation of baseline right dlPFC activity during conflict decision-making with baseline GAD-7 scores.||||.651
70966964|NCT02807480|141440637|OTHER|Correlation of baseline striatum response to negative pictures with baseline GAD-7 scores.|Pearson correlation|-0.35||||0.008|TWO_SIDED||||||Pearson correlation|||||||.008
70966965|NCT02807480|141440638|OTHER||Slope|-1.51||||0.007|TWO_SIDED|95.0|-2.62|-0.41||The a priori threshold for statistical significance after Bonferroni correction for multiple comparisons was p\<.0071.|Regression, Linear||Those with lower levels of baseline left amygdala response to positive picture outcomes had favorable GAD symptom improvements in BA and limited GAD symptom improvements in EXP.|Assess left amygdala response to positive picture decision outcomes as a predictor of GAD-7 symptom improvement: time x L. Amyg x treatment-arm interaction||-0.41|-2.62|.007
70966966|NCT02807480|141440638|OTHER||Slope|0.36||||0.238|TWO_SIDED|95.0|-0.24|0.97|||Regression, Linear|||Baseline approach behavior during conflict trials predicting trajectory of GAD-7 symptoms: time main effect||0.97|-0.24|0.238
70966967|NCT02807480|141440638|SUPERIORITY||Slope|-0.49||||0.262|TWO_SIDED|95.0|-1.36|0.37|||Regression, Linear|||Relationship between baseline approach behavior on conflict trials and the trajectory of GAD-7 symptoms: time x treatment interaction effect||0.37|-1.36|.262
70966968|NCT02807480|141440638|OTHER||Slope|2.37||||0.222|TWO_SIDED|95.0|-1.44|6.19|||Regression, Linear|||relationship between baseline response time on conflict trials and trajectory of GAD-7 symptoms: time main effects||6.19|-1.44|.222
70966969|NCT02807480|141440638|SUPERIORITY||Slope|-0.23||||0.942|TWO_SIDED|95.0|-6.48|6.02|||Regression, Linear|||Relationship between baseline average RT during conflict trials on the AAC and trajectory of GAD-7 symptoms: time x treatment interaction effect||6.02|-6.48|.942
70966970|NCT02807480|141440638|OTHER||Slope|-0.05||||0.932|TWO_SIDED|95.0|-1.2|1.1|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with GAD-7 trajectory: time main effects||1.1|-1.2|.932
70966971|NCT02807480|141440638|SUPERIORITY||Slope|-0.08||||0.922|TWO_SIDED|95.0|-1.7|1.53|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with GAD-7 trajectory: time x treatment interaction effects||1.53|-1.7|.922
70966972|NCT02807480|141440638|OTHER||Slope|0.0||||0.998|TWO_SIDED|95.0|-0.99|0.99|||Regression, Linear|||Relationship of right amygdala activity during negative images with GAD-7 trajectory: time main effects||.99|-.99|.998
70966973|NCT02807480|141440638|SUPERIORITY||Slope|-0.88||||0.234|TWO_SIDED|95.0|-2.34|0.57|||Regression, Linear|||Relationship of right amygdala activity during negative images with GAD-7 trajectory: time x treatment interaction||.57|-2.34|.234
70966974|NCT02807480|141440638|OTHER||Slope|-0.03||||0.967|TWO_SIDED|95.0|-1.53|1.47|||Regression, Linear|||Relationship of right dlPFC activity during conflict decisions with GAD-7 trajectory: time main effects||1.47|-1.53|.967
70966975|NCT02807480|141440638|OTHER||Slope|0.74||||0.504|TWO_SIDED|95.0|-1.43|2.91|||Regression, Linear|||Relationship of right dlPFC activity during conflict decision-making with GAD-7 trajectory: time x treatment interaction effect||2.91|-1.43|0.504
70966976|NCT02807480|141440638|OTHER||Slope|-1.68||||0.612|TWO_SIDED|95.0|-8.21|4.84|||Regression, Linear|||Change in conflict arbitration (AAC conflict RTpost-RTpre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x RT\_Change interaction||4.84|-8.21|0.612
70966977|NCT02807480|141440638|SUPERIORITY||Slope|5.08||||0.259|TWO_SIDED|95.0|-3.76|13.92|||Regression, Linear|||change in conflict arbitration response time (AAC conflict RTpost-RTpre) predicting trajectories of GAD-7 scores over 10 sessions: RT\_Change x Time x Treatment interaction||13.92|-3.76|.259
70966978|NCT02807480|141440638|OTHER||Slope|-0.53||||0.209|TWO_SIDED|95.0|-1.35|0.3|||Regression, Linear|||Change in behavior (AAC conflict post-pre) in predicting trajectories of GAD-7 scores over the 10 sessions: Time x Behavior\_change interaction||0.30|-1.35|.209
70966979|NCT02807480|141440638|SUPERIORITY||Slope|1.53||||0.013|TWO_SIDED|95.0|0.33|2.73|||Regression, Linear|||Change in behavior (AAC conflict post-pre) in predicting trajectories of GAD-7 scores over the 10 sessions: Time x Behavior\_change x Treatment interaction||2.73|0.33|0.013
70966980|NCT02807480|141440639|OTHER||Slope|-2.95||||0.006|TWO_SIDED|95.0|-5.06|-0.84||The a priori threshold for statistical significance after Bonferroni correction for multiple comparisons was p\<.0125.|Regression, Linear|||Baseline emotional conflict, a computational parameter reflecting avoidance relative to reward value, as a predictor of the linear trajectory of symptom change over time: time x EC interaction||-0.84|-5.06|0.006
70966981|NCT02807480|141440639|OTHER||Slope|-1.02||||0.003|TWO_SIDED|95.0|-1.68|-0.36|||Regression, Linear|||Assess avoidance behavior on conflict trials as a predictor of PROMIS Anxiety symptom improvement: time x avoidance interaction||-0.36|-1.68|0.003
70966982|NCT02807480|141440639|OTHER||Slope|-1.88||||0.007|TWO_SIDED|95.0|-2.89|-0.87||The a priori threshold for statistical significance after Bonferroni correction for multiple comparisons was p\<.0071.|Regression, Linear|||Assess left dlPFC response to baseline negative picture decision outcomes as a predictor of PROMIS Anxiety symptom improvement: time x L. dlPFC interaction||-0.87|-2.89|.007
70966983|NCT02807480|141440639|OTHER||Slope|1.02||||0.003|TWO_SIDED|95.0|0.36|1.68|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and trajectory of PROMIS Anxiety symptoms||1.68|0.36|.003
70966984|NCT02807480|141440639|SUPERIORITY||Slope|-0.54||||0.258|TWO_SIDED|95.0|-1.48|0.4|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and trajectory of PROMIS Anxiety symptoms: time x treatment x approach behavior interaction||0.4|-1.48|.258
70966985|NCT02807480|141440639|OTHER||Slope|1.3||||0.56|TWO_SIDED|95.0|-3.08|5.69|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of PROMIS Anxiety symptoms: time x approach behavior interaction||5.69|-3.08|.56
70966986|NCT02807480|141440639|SUPERIORITY||Slope|-1.77||||0.629|TWO_SIDED|95.0|-8.95|5.41|||Regression, Linear|||Relationships between baseline average RT (response time) during conflict trials on the AAC and trajectory of PROMIS Anxiety symptoms: time x treatment x RT interaction||5.41|-8.95|.629
70966987|NCT02807480|141440639|OTHER||Slope|-0.21||||0.75|TWO_SIDED|95.0|-1.51|1.09|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with PROMIS ANXIETY trajectory: time x striatum interaction effects||1.09|-1.51|0.75
70966988|NCT02807480|141440639|SUPERIORITY||Slope|1.27||||0.169|TWO_SIDED|95.0|-0.54|3.09|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with PROMIS Anxiety trajectory: time x treatment x striatum interaction effects||3.09|-0.54|.169
70966989|NCT02807480|141440639|OTHER||Slope|0.15||||0.792|TWO_SIDED|95.0|-1.0|1.31|||Regression, Linear|||Relationship of right amygdala activity during negative images with PROMIS Anxiety trajectory: time x amygdala interaction||1.31|-1.00|0.792
70966990|NCT02807480|141440639|SUPERIORITY||Slope|-0.73||||0.396|TWO_SIDED|95.0|-2.41|0.96|||Regression, Linear|||Relationship of right amygdala activity during negative images with PROMIS Anxiety trajectory: time x treatment amygdala interaction||0.96|-2.41|.396
70966991|NCT02807480|141440639|OTHER||Slope|-1.55||||0.009|TWO_SIDED|95.0|-2.7|-0.4|||Regression, Linear|||Relationship of right dlPFC activity during negative images with PROMIS Anxiety trajectory: time x dlPFC interaction||-0.4|-2.7|.009
70966992|NCT02807480|141440639|SUPERIORITY||Slope|0.28||||0.724|TWO_SIDED|95.0|-1.28|1.84|||Regression, Linear|||Relationship of right dlPFC activity during negative images with PROMIS Anxiety trajectory: time x treatment dlPFC interaction||1.84|-1.28|0.724
70966993|NCT02807480|141440639|OTHER||Slope|-4.99||||0.209|TWO_SIDED|95.0|-12.79|2.8|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x RT\_change interaction||2.80|-12.79|.209
70966994|NCT02807480|141440639|SUPERIORITY||Slope|12.68||||0.017|TWO_SIDED|95.0|2.23|23.13|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x Treatment x RT\_change interaction||23.13|2.23|0.017
70966995|NCT02807480|141440639|OTHER||Slope|-0.58||||0.259|TWO_SIDED|95.0|-1.59|0.43|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x Behavior\_change interaction||0.43|-1.59|.259
70966996|NCT02807480|141440639|OTHER||Slope|1.07||||0.15|TWO_SIDED|95.0|-0.39|2.54|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x Treatment x Behavior\_change interaction||2.54|-0.39|.150
70966997|NCT02807480|141440640|OTHER||Slope|-3.52||||0.001|TWO_SIDED|95.0|-5.57|-1.47||The a priori threshold for statistical significance after Bonferroni correction for multiple comparisons was p\<.0125.|Regression, Linear|||Assess emotional conflict, a computational parameter reflecting avoidance relative to reward value, as a predictor of PROMIS Depression scores. Time x EC interaction.||-1.47|-5.57|0.001
70966998|NCT02807480|141440640|OTHER||Slope|-1.93|||<|0.001|TWO_SIDED|95.0|-2.91|-0.95||The a priori threshold for statistical significance after Bonferroni correction for multiple comparisons was p\<.0125.|Regression, Linear|||Baseline left dlPFC response to negative pictures as a predictor of PROMIS depression symptom improvement: time x L. dlFPC interaction.||-0.95|-2.91|<.001
70966999|NCT02807480|141440640|OTHER||Slope|-2.02||||0.036|TWO_SIDED|95.0|-3.9|-0.13||Threshold for statistical significance is 0.05.|Regression, Linear|||Baseline striatum response to monetary outcomes as a predictor of improvement in depressive symptoms: time x treatment x striatum interaction.||-0.13|-3.9|.036
70967000|NCT02807480|141440640|OTHER||Slope|-1.21|||<|0.001|TWO_SIDED|95.0|-1.85|-0.58||The a priori threshold for statistical significance after Bonferroni correction for multiple comparisons was p\<.0125.|Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and trajectory of PROMIS Depression symptoms: time x approach behavior interaction||-0.58|-1.85|<.001
70967001|NCT02807480|141440640|SUPERIORITY||Slope|-0.91||||0.049|TWO_SIDED|95.0|-1.81|0.0|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and trajectory of PROMIS Depression symptoms: time x treatment x approach behavior interaction||0.00|-1.81|.049
70967002|NCT02807480|141440640|OTHER||Slope|0.6||||0.778|TWO_SIDED|95.0|-3.6|4.81|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of PROMIS Depression symptoms: time x RT interaction||4.81|-3.6|.778
70967003|NCT02807480|141440640|SUPERIORITY||Slope|1.38||||0.696|TWO_SIDED|95.0|-5.56|8.31|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of PROMIS Depression symptoms: time x treatment x RT interaction||8.31|-5.56|.696
70967004|NCT02807480|141440640|OTHER||Slope|0.44||||0.503|TWO_SIDED|95.0|-0.84|1.71|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with PROMIS Depression trajectory: time x striatum interaction effects||1.71|-0.84|.503
70967005|NCT02807480|141440640|OTHER||Slope|-0.9||||0.114|TWO_SIDED|95.0|-2.02|0.22|||Regression, Linear|||Relationship of right amygdala activity during negative images with PROMIS Depression trajectory: time x amygdala interaction||.22|-2.02|.114
70967006|NCT02807480|141440640|SUPERIORITY||Slope|0.48||||0.561|TWO_SIDED|95.0|-1.15|2.11|||Regression, Linear|||Relationship of right amygdala activity during negative images with PROMIS Depression trajectory: time x treatment amygdala interaction||2.11|-1.15|.561
70967007|NCT02807480|141440640|OTHER||Slope|-1.54||||0.007|TWO_SIDED|95.0|-2.66|-0.42|||Regression, Linear|||Relationship of right dlPFC activity during negative images with PROMIS Depression trajectory: time x dlPFC interaction||-0.42|-2.66|.007
70967008|NCT02807480|141440640|SUPERIORITY||Slope|0.65||||0.403|TWO_SIDED|95.0|-0.87|2.17|||Regression, Linear|||Relationship of right dlPFC activity during negative images with PROMIS Depression trajectory: time x treatment dlPFC interaction||2.17|-0.87|0.403
70967009|NCT02807480|141440640|OTHER||Slope|-1.51||||0.681|TWO_SIDED|95.0|-8.76|5.73|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x RT\_change interaction||5.73|-8.76|0.681
70967010|NCT02807480|141440640|SUPERIORITY||Slope|5.61||||0.264|TWO_SIDED|95.0|-4.24|15.46|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x Treatment x RT\_change interaction||15.46|-4.24|.264
70967011|NCT02807480|141440640|OTHER||Slope|-0.43||||0.367|TWO_SIDED|95.0|-1.38|0.51|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x Behavior\_change interaction||0.51|-1.38|.367
70967012|NCT02807480|141440640|OTHER||Slope|0.88||||0.211|TWO_SIDED|95.0|-0.5|2.25|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x Treatment x Behavior\_change interaction||2.25|-0.50|.211
70967013|NCT02807480|141440641|OTHER||Slope|0.74||||0.028|TWO_SIDED|95.0|0.08|1.41|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and trajectory of SDS score: time x approach behavior interaction||1.41|0.08|0.028
70967014|NCT02807480|141440641|SUPERIORITY||Slope|-0.55||||0.251|TWO_SIDED|95.0|-1.49|0.39|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and trajectory of SDS symptoms: time x treatment x approach behavior interaction||0.39|-1.49|0.251
70967015|NCT02807480|141440641|OTHER||Slope|-0.26||||0.902|TWO_SIDED|95.0|-4.49|3.96|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of SDS symptoms: time x RT interaction||3.96|-4.49|0.902
70967016|NCT02807480|141440641|SUPERIORITY||Slope|2.23||||0.519|TWO_SIDED|95.0|-4.55|9.01|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of SDS symptoms: time x treatment x RT interaction||9.01|-4.55|.519
70967017|NCT02807480|141440641|OTHER||Slope|-0.64||||0.326|TWO_SIDED|95.0|-1.92|0.64|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with SDS trajectory: time x striatum interaction effects||0.64|-1.92|.326
70967018|NCT02807480|141440641|SUPERIORITY||Slope|1.26||||0.168|TWO_SIDED|95.0|-0.53|3.05|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with SDS trajectory: time x treatment x striatum interaction effects||3.05|-0.53|.168
70967019|NCT02807480|141440641|OTHER||Slope|-0.5||||0.248|TWO_SIDED|95.0|-1.34|0.35|||Regression, Linear|||Relationship of right amygdala activity during negative images with SDS trajectory: time x amygdala interaction||0.35|-1.34|.248
70967020|NCT02807480|141440641|SUPERIORITY||Slope|0.3||||0.603|TWO_SIDED|95.0|-0.84|1.44|||Regression, Linear|||Relationship of right amygdala activity during negative images with SDS trajectory: time x treatment amygdala interaction||1.44|-0.84|0.603
70967021|NCT02807480|141440641|OTHER||Slope|-0.85||||0.107|TWO_SIDED|95.0|-1.89|0.18|||Regression, Linear|||Relationship of right dlPFC activity during negative images with SDS trajectory: time x dlPFC interaction||0.18|-1.89|.107
70967022|NCT02807480|141440641|SUPERIORITY||Slope|0.16||||0.846|TWO_SIDED|95.0|-1.47|1.8|||Regression, Linear|||Relationship of right dlPFC activity during negative images with SDS trajectory: time x treatment x dlPFC interaction||1.80|-1.47|0.846
70967023|NCT02807480|141440641|OTHER||Slope|-2.26||||0.561|TWO_SIDED|95.0|-9.89|5.37|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of SDS scores over the 10 sessions: Time x RT\_change interaction||5.37|-9.89|.561
70967024|NCT02807480|141440641|SUPERIORITY||Slope|5.45||||0.297|TWO_SIDED|95.0|-4.8|15.7|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of SDS scores over the 10 sessions: Time x Treatment x RT\_change interaction||15.70|-4.80|.297
70967025|NCT02807480|141440641|OTHER||Slope|-0.18||||0.712|TWO_SIDED|95.0|-1.15|0.79|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of SDS cores over the 10 sessions: Time x Behavior\_change interaction||0.79|-1.15|.712
70967026|NCT02807480|141440641|SUPERIORITY||Slope|0.56||||0.431|TWO_SIDED|95.0|-0.84|1.97|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of SDS scores over the 10 sessions: Time x Treatment x Behavior\_change interaction||1.97|-0.84|0.431
70967027|NCT02807480|141440642|OTHER||Slope|-6.42||||0.276|TWO_SIDED|95.0|-18.15|5.3|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and post-treatment PSWQ score: approach behavior main effect||5.30|-18.15|.276
70967028|NCT02807480|141440642|SUPERIORITY||Slope|5.69||||0.52|TWO_SIDED|95.0|-12.12|23.5|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and post-treatment PSWQ score: treatment x approach behavior interaction||23.50|-12.12|.520
70967029|NCT02807480|141440642|OTHER||Slope|-50.0||||0.199|TWO_SIDED|95.0|-127.65|27.65|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of PSWQ score: RT main effect||27.65|-127.65|.199
70967030|NCT02807480|141440642|SUPERIORITY||Slope|93.87||||0.191|TWO_SIDED|95.0|-4.14|236.88|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of PSWQ score: treatment x RT interaction||236.88|-4.14|.191
70967031|NCT02807480|141440642|OTHER||Slope|27.35||||0.021|TWO_SIDED|95.0|4.45|50.26|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with PSWQ trajectory: striatum main effect||50.26|4.45|0.021
70967032|NCT02807480|141440642|SUPERIORITY||Slope|-5.47||||0.734|TWO_SIDED|95.0|-37.94|27.0|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with PSWQ post-treatment: treatment x striatum interaction effects||27.00|-37.94|.734
70967033|NCT02807480|141440642|OTHER||Slope|-9.79||||0.231|TWO_SIDED|95.0|-26.11|6.53|||Regression, Linear|||Relationship of right amygdala activity during negative images with PSWQ post-treatment: amygdala main effect||6.53|-26.11|.231
70967034|NCT02807480|141440642|SUPERIORITY||Slope|8.55||||0.602|TWO_SIDED|95.0|-24.48|41.58|||Regression, Linear|||Relationship of right amygdala activity during negative images with PSWQ post-treatment: treatment amygdala interaction||41.58|-24.48|.602
70967035|NCT02807480|141440642|OTHER||Slope|-19.29||||0.369|TWO_SIDED|95.0|-62.07|23.68|||Regression, Linear|||Relationship of right dlPFC activity during negative images with PSWQ post-treatment: dlPFC main effect||23.68|-62.07|.369
70967036|NCT02807480|141440642|SUPERIORITY||Slope|9.12||||0.684|TWO_SIDED|95.0|-36.05|54.29|||Regression, Linear|||Relationship of right dlPFC activity during negative images with PSWQ post-treatment: treatment x dlPFC interaction||54.29|-36.05|.684
70967037|NCT02807480|141440642|OTHER||Slope|9.6||||0.487|TWO_SIDED|95.0|-18.39|37.59|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of PSWQ cores over the 10 sessions: Behavior\_change main effect||37.59|-18.39|.487
70967038|NCT02807480|141440642|SUPERIORITY||Slope|-46.34||||0.033|TWO_SIDED|95.0|-88.5|-4.18|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of PSWQ scores over the 10 sessions: Treatment x Behavior\_change interaction||-4.18|-88.5|.033
70967039|NCT02807480|141440642|OTHER||Slope|39.53||||0.546|TWO_SIDED|95.0|-94.2|173.85|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of PSWQ scores over the 10 sessions: RT\_change main effect||173.85|-94.2|.546
70967040|NCT02807480|141440642|SUPERIORITY||Slope|-89.96||||0.443|TWO_SIDED|95.0|-327.39|147.67|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of PSWQ scores over the 10 sessions: Treatment x RT\_change interaction||147.67|-327.39|.443
70967041|NCT02807480|141440643|OTHER||Slope|-1.01||||0.357|TWO_SIDED|95.0|-3.22|1.19|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and post-treatment BDI-II score: approach behavior main effect||1.19|-3.22|.357
70967042|NCT02807480|141440643|SUPERIORITY||Slope|0.37||||0.812|TWO_SIDED|95.0|-2.74|3.47|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and post-treatment BDI-II score: treatment x approach behavior interaction||3.47|-2.74|.812
70967043|NCT02807480|141440643|OTHER||Slope|2.01||||0.826|TWO_SIDED|95.0|-16.42|20.45|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and post-treatment BDI-II score: RT main effect||20.45|-16.42|.826
70967044|NCT02807480|141440643|SUPERIORITY||Slope|-2.89||||0.838|TWO_SIDED|95.0|-31.42|25.64|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and post-treatment BDI-II score: treatment x RT interaction||25.64|-31.42|.838
70967045|NCT02807480|141440643|OTHER||Slope|-0.68||||0.776|TWO_SIDED|95.0|-5.51|4.14|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with BDI-II post-treatment: striatum main effect||4.14|-5.51|.776
70967046|NCT02807480|141440643|SUPERIORITY||Slope|-0.69||||0.844|TWO_SIDED|95.0|-7.79|6.4|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with BDI-II post-treatment: treatment x striatum interaction effects||6.40|-7.79|.844
70967047|NCT02807480|141440643|OTHER||Slope|0.88||||0.719|TWO_SIDED|95.0|-4.03|5.79|||Regression, Linear|||Relationship of right amygdala activity during negative images with BDI-II post-treatment: amygdala main effect||5.79|-4.03|.719
70967048|NCT02807480|141440643|SUPERIORITY||Slope|-2.33||||0.464|TWO_SIDED|95.0|-8.74|4.07|||Regression, Linear|||Relationship of right amygdala activity during negative images with BDI-II post-treatment: treatment x amygdala interaction||4.07|-8.74|.464
70967049|NCT02807480|141440643|OTHER||Slope|5.91||||0.135|TWO_SIDED|95.0|-1.93|13.75|||Regression, Linear|||Relationship of right dlPFC activity during negative images with BDI-II post-treatment: dlPFC main effect||13.75|-1.93|.135
70967050|NCT02807480|141440643|SUPERIORITY||Slope|-6.09||||0.158|TWO_SIDED|95.0|-14.65|2.47|||Regression, Linear|||Relationship of right dlPFC activity during negative images with BDI-II post-treatment: treatment x dlPFC interaction||2.47|-14.65|.158
70967051|NCT02807480|141440643|OTHER||Slope|1.16||||0.69|TWO_SIDED|95.0|-4.78|7.11|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of BDI-II cores over the 10 sessions: Behavior\_change main effect||7.11|-4.78|.690
70967052|NCT02807480|141440643|SUPERIORITY||Slope|-1.37||||0.715|TWO_SIDED|95.0|-8.99|6.25|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of BDI-II scores over the 10 sessions: Treatment x Behavior\_change interaction||6.25|-8.99|.715
70967053|NCT02807480|141440643|OTHER||Slope|5.14||||0.74|TWO_SIDED|95.0|-26.38|36.65|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of BDI-II scores over the 10 sessions: RT\_change main effect||36.65|-26.38|.740
70967054|NCT02807480|141440643|SUPERIORITY||Slope|-0.98||||0.966|TWO_SIDED|95.0|-48.1|46.14|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of BDI-II scores over the 10 sessions: Treatment x RT\_change interaction||46.14|-48.10|.966
70967055|NCT00054704|141440644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.828|STANDARD_ERROR_OF_MEAN|3.182||0.086|TWO_SIDED|95.0|-12.59|0.934||A linear mixed model included drug, visit and their interaction as fixed factors. Subject was a random factor. The test here is for the main effect of drug.|Mixed Models Analysis|Baseline score was a covariate. Restricted maximum likelihood estimates were used with a compound symmetry covariance structure.||The primary intent of this study was to compare the efficacy of riluzole to placebo in the treatment of overall depressive symptomatology of bipolar disorder subjects who were acutely depressed. Data from 8 riluzole and 11 placebo participants were analyzed due to missing data for one riluzole patient.||0.934|-12.590|.086
70967056|NCT02187471|141440744|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.191||0.4601|TWO_SIDED|95.0|-0.52|0.23|||Difference of means|||||0.23|-0.52|0.4601
70967057|NCT02187471|141440744|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.035|TWO_SIDED|95.0|-0.77|-0.03|||Difference of means|||||-0.03|-0.77|0.0350
70967058|NCT02187471|141440744|SUPERIORITY||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.191||0.0001|TWO_SIDED|95.0|-1.12|-0.37|||Difference of means|||||-0.37|-1.12|0.0001
70967059|NCT02187471|141440744|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.193||0.0019|TWO_SIDED|95.0|0.22|0.98|||Difference of means|||||0.98|0.22|0.0019
70967060|NCT02187471|141440744|SUPERIORITY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.192||0.0761|TWO_SIDED|95.0|-0.04|0.72|||Difference of means|||||0.72|-0.04|0.0761
70967061|NCT02187471|141440746|SUPERIORITY||Mean Difference (Final Values)|-1.59|STANDARD_ERROR_OF_MEAN|1.67||0.3407|TWO_SIDED|95.0|-4.86|1.68|||Difference of means|||||1.68|-4.86|0.3407
70967062|NCT02187471|141440746|SUPERIORITY||Mean Difference (Final Values)|-5.42|STANDARD_ERROR_OF_MEAN|1.669||0.0012|TWO_SIDED|95.0|-8.69|-2.15|||Difference of means|||||-2.15|-8.69|0.0012
70967063|NCT02187471|141440746|SUPERIORITY||Mean Difference (Final Values)|-4.39|STANDARD_ERROR_OF_MEAN|1.665||0.0083|TWO_SIDED|95.0|-7.66|-1.13|||Difference of means|||||-1.13|-7.66|0.0083
70967064|NCT02187471|141440746|SUPERIORITY||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|1.677||0.0946|TWO_SIDED|95.0|-0.48|6.09|||Difference of means|||||6.09|-0.48|0.0946
70967065|NCT02187471|141440746|SUPERIORITY||Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|1.669||0.5384|TWO_SIDED|95.0|-4.3|2.24|||Difference of means|||||2.24|-4.30|0.5384
70967066|NCT02187471|141440748|SUPERIORITY||Difference in least squares means|-0.9|STANDARD_ERROR_OF_MEAN|0.3||0.003|TWO_SIDED|95.0|-1.5|-0.3|||ANCOVA|||||-0.3|-1.5|0.0030
70967067|NCT02187471|141440748|SUPERIORITY||Difference in least squares means|-1.7|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.3|-1.1|||ANCOVA|||||-1.1|-2.3|<0.0001
70967068|NCT02187471|141440748|SUPERIORITY||Difference in least squares means|-1.2|STANDARD_ERROR_OF_MEAN|0.3||0.0001|TWO_SIDED|95.0|-1.7|-0.6|||ANCOVA|||||-0.6|-1.7|0.0001
70967069|NCT02187471|141440748|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3562|TWO_SIDED|95.0|-0.3|0.9|||ANCOVA|||||0.9|-0.3|0.3562
70967070|NCT02187471|141440748|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.0862|TWO_SIDED|95.0|-1.1|0.1|||ANCOVA|||||0.1|-1.1|0.0862
70967071|NCT02187471|141440749|SUPERIORITY||Difference in least square means|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.5183|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||Anxiety: Placebo vs DS-5565 15 mg QD||0.4|-0.7|0.5183
70967072|NCT02187471|141440749|SUPERIORITY||Difference in least squares mean|-0.3|STANDARD_ERROR_OF_MEAN|0.28||0.2669|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|||Anxiety: Placebo vs DS-5565 15 mg BID||0.2|-0.9|0.2669
70967073|NCT02187471|141440749|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.463|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||Anxiety: Placebo vs Pregabalin 150 mg BID||0.3|-0.8|0.4630
70967074|NCT02187471|141440749|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.28||0.928|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||Anxiety: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.6|-0.5|0.9280
70967075|NCT02187471|141440749|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.28||0.7089|TWO_SIDED|95.0|-0.7|0.5|||ANCOVA|||Anxiety: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.5|-0.7|0.7089
70967076|NCT02187471|141440749|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.28||0.0669|TWO_SIDED|95.0|-1.1|0.0|||ANCOVA|||Depression: Placebo vs DS-5565 15 mg QD||0|-1.1|0.0669
70967077|NCT02187471|141440749|SUPERIORITY||Difference in least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.28||0.0081|TWO_SIDED|95.0|-1.3|-0.2|||ANCOVA|||Depression: Placebo vs DS-5565 15 mg BID||-0.2|-1.3|0.0081
70967078|NCT02187471|141440749|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.28||0.0867|TWO_SIDED|95.0|-1.0|0.1|||ANCOVA|||Depression: Placebo vs Pregabalin 150 mg BID||0.1|-1.0|0.0867
70967079|NCT02187471|141440749|SUPERIORITY||Difference of least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.29||0.9066|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||Depression: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.5|-0.6|0.9066
70967080|NCT02187471|141440749|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.29||0.3509|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||Depression: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.3|-0.8|0.3509
70967081|NCT02187471|141440750|SUPERIORITY||Difference in least squares means|2.187|STANDARD_ERROR_OF_MEAN|0.6203||0.0004|TWO_SIDED|95.0|0.97|3.404|||ANCOVA|||Physical Component: Placebo vs DS-5565 15 mg QD||3.404|0.970|0.0004
70967082|NCT02187471|141440750|SUPERIORITY||Difference of least squares means|2.483|STANDARD_ERROR_OF_MEAN|0.6209|<|0.0001|TWO_SIDED|95.0|1.265|3.701|||ANCOVA|||Physical Component: Placebo vs DS-5565 15 mg BID||3.701|1.265|<0.0001
70967083|NCT02187471|141440750|SUPERIORITY||Difference in least squares means|2.621|STANDARD_ERROR_OF_MEAN|0.6215|<|0.0001|TWO_SIDED|95.0|1.401|3.84|||ANCOVA|||Physical Component: Placebo vs Pregabalin 150 mg BID||3.840|1.401|<0.0001
70967084|NCT02187471|141440750|SUPERIORITY||Difference in least squares means|-0.434|STANDARD_ERROR_OF_MEAN|0.6245||0.4877|TWO_SIDED|95.0|-1.659|0.792|||ANCOVA|||Physical Component: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.792|-1.659|0.4877
70967085|NCT02187471|141440750|SUPERIORITY||Difference in least squares means|-0.137|STANDARD_ERROR_OF_MEAN|0.6252||0.8263|TWO_SIDED|95.0|-1.364|1.089|||ANCOVA|||Physical Component: Pregabalin 150 mg BID vs DS-5565 15 mg BID||1.089|-1.364|0.8263
70967086|NCT02187471|141440750|SUPERIORITY||Difference in least squares means|0.228|STANDARD_ERROR_OF_MEAN|0.7345||0.7567|TWO_SIDED|95.0|-1.213|1.669|||ANCOVA|||Mental Component: Placebo vs DS-5565 15 mg QD||1.669|-1.213|0.7567
70967087|NCT02187471|141440750|SUPERIORITY||Difference in least squares means|0.7349|STANDARD_ERROR_OF_MEAN|0.7349||0.0787|TWO_SIDED|95.0|-0.149|2.735|||ANCOVA|||Mental Component: Placebo vs DS-5565 15 mg BID||2.735|-0.149|0.0787
70967088|NCT02187471|141440750|SUPERIORITY||Difference in least squares means|0.7358|STANDARD_ERROR_OF_MEAN|0.7358||0.3516|TWO_SIDED|95.0|-0.758|2.129|||ANCOVA|||Mental Component: Placebo vs Pregabalin 150 mg BID||2.129|-0.758|0.3516
70967089|NCT02187471|141440750|SUPERIORITY||Difference in least squares means|-0.458|STANDARD_ERROR_OF_MEAN|0.7372||0.5344|TWO_SIDED|95.0|-1.905|0.988|||ANCOVA|||Mental Component: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.988|-1.905|0.5344
70967090|NCT02187471|141440750|SUPERIORITY||Difference in least squares means|0.607|STANDARD_ERROR_OF_MEAN|0.7379||0.4107|TWO_SIDED|95.0|-0.84|2.055|||ANCOVA|||Mental Component: Pregabalin 150 mg BID vs DS-5565 15 mg BID||2.055|-0.840|0.4107
70967091|NCT02187471|141440751|SUPERIORITY||Difference in least squares means|0.0203|STANDARD_ERROR_OF_MEAN|0.01369||0.1394|TWO_SIDED|95.0|-0.0066|0.0471|||ANCOVA|||||0.0471|-0.0066|0.1394
70967092|NCT02187471|141440751|SUPERIORITY||Difference in least squares means|0.0211|STANDARD_ERROR_OF_MEAN|0.01369||0.1237|TWO_SIDED|95.0|-0.0058|0.048|||ANCOVA|||||0.0480|-0.0058|0.1237
70967093|NCT02187471|141440751|SUPERIORITY||Difference in least squares means|0.0386|STANDARD_ERROR_OF_MEAN|0.01371||0.0049|TWO_SIDED|95.0|0.0117|0.0655|||ANCOVA|||||0.0655|0.0117|0.0049
70967094|NCT02187471|141440751|SUPERIORITY||Difference in least squares means|-0.0184|STANDARD_ERROR_OF_MEAN|0.01378||0.1824|TWO_SIDED|95.0|-0.0454|0.0086|||ANCOVA|||||0.0086|-0.0454|0.1824
70967095|NCT02187471|141440751|SUPERIORITY||Difference in least squares means|-0.0175|STANDARD_ERROR_OF_MEAN|0.01378||0.2036|TWO_SIDED|95.0|-0.0446|0.0095|||ANCOVA|||||0.0095|-0.0446|0.2036
70967096|NCT02187471|141440752|SUPERIORITY||Difference in least squares means|-0.56|STANDARD_ERROR_OF_MEAN|0.162||0.0006|TWO_SIDED|95.0|-0.87|-0.24|||Mixed Models Analysis|||||-0.24|-0.87|0.0006
70967097|NCT02187471|141440752|SUPERIORITY||Difference in least squares means|-0.88|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.2|-0.57|||Mixed Models Analysis|||||-0.57|-1.20|<0.0001
70967098|NCT02187471|141440752|SUPERIORITY||Difference in least squares means|-0.95|STANDARD_ERROR_OF_MEAN|0.161|<|0.0001|TWO_SIDED|95.0|-1.27|-0.63|||Mixed Models Analysis|||||-0.63|-1.27|<0.0001
70967099|NCT02187471|141440752|SUPERIORITY||Difference in least squares means|0.39|STANDARD_ERROR_OF_MEAN|0.162||0.0158|TWO_SIDED|95.0|0.07|0.71|||Mixed Models Analysis|||||0.71|0.07|0.0158
70967100|NCT02187471|141440752|SUPERIORITY||Difference in least squares means|0.07|STANDARD_ERROR_OF_MEAN|0.161||0.6819|TWO_SIDED|95.0|-0.25|0.38|||Mixed Models Analysis|||||0.38|-0.25|0.6819
70967101|NCT02187471|141440754|SUPERIORITY||Difference of least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||ANCOVA|||Worst pain: Placebo vs Pregabalin 150 mg BID||-0.4|-1.2|<0.0001
70967102|NCT02187471|141440754|SUPERIORITY||Difference of least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.2005|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||Worst pain: Placebo vs DS-5565 15 mg QD||0.1|-0.6|0.2005
70967103|NCT02187471|141440754|SUPERIORITY||Difference in least squares means|-0.6|STANDARD_ERROR_OF_MEAN|0.19||0.001|TWO_SIDED|95.0|-1.0|-0.3|||ANCOVA|||Worst pain: Placebo vs DS-5565 15 mg BID||-0.3|-1.0|0.0010
70967104|NCT02187471|141440754|SUPERIORITY||Difference in least squares means|0.6|STANDARD_ERROR_OF_MEAN|0.19||0.003|TWO_SIDED|95.0|0.2|1.0|||ANCOVA|||Worst pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||1.0|0.2|0.0030
70967105|NCT02187471|141440754|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.19||0.3351|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Worst pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.6|-0.2|0.3351
70967106|NCT02187471|141440754|SUPERIORITY||Difference in least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.1|-0.4|||ANCOVA|||Least pain: Placebo vs Pregabalin 150 mg BID||-0.4|-1.1|<0.0001
70967107|NCT02187471|141440754|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.0782|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|||Least pain: Placebo vs DS-5565 15 mg QD||0.0|-0.7|0.0782
70967108|NCT02187471|141440754|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.0068|TWO_SIDED|95.0|-0.9|-0.1|||ANCOVA|||Least pain: Placebo vs DS-5565 15 mg BID||-0.1|-0.9|0.0068
70967109|NCT02187471|141440754|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.19||0.0169|TWO_SIDED|95.0|0.1|0.8|||ANCOVA|||Least pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|0.1|0.0169
70967110|NCT02187471|141440754|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.19||0.1481|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Least pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.6|-0.1|0.1481
70967111|NCT02187471|141440754|SUPERIORITY||Difference in least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.1|-0.4|||ANCOVA|||Average pain: Placebo vs Pregabalin 150 mg BID||-0.4|-1.1|<0.0001
70967112|NCT02187471|141440754|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0088|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|||Average pain: Placebo vs DS-5565 15 mg QD||-0.1|-0.8|0.0088
70967113|NCT02187471|141440754|SUPERIORITY||Difference in least squares means|-0.6|STANDARD_ERROR_OF_MEAN|0.17||0.0005|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|||Average pain: Placebo vs DS-5565 15 mg BID||-0.3|-0.9|0.0005
70967114|NCT02187471|141440754|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.17||0.0627|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Average pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.7|-0.0|0.0627
70967115|NCT02187471|141440754|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.17||0.3064|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Average pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.5|-0.2|0.3064
70967116|NCT02187471|141440754|SUPERIORITY||Difference in least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||ANCOVA|||Pain right now: Placebo vs Pregabalin 150 mg BID||-0.4|-1.2|<0.0001
70967117|NCT02187471|141440754|SUPERIORITY||Difference in least squares mean|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.0868|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|||Pain right now: Placebo vs DS-5565 15 mg QD||0.0|-0.7|0.0868
70967118|NCT02187471|141440754|SUPERIORITY||Difference in least squares means|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0004|TWO_SIDED|95.0|-1.1|-0.3|||ANCOVA|||Pain right now: Placebo vs DS-5565 15 mg BID||-0.3|-1.1|0.0004
70967119|NCT02187471|141440754|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0271|TWO_SIDED|95.0|0.1|0.8|||ANCOVA|||Pain right now: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|0.1|0.0271
70967120|NCT02187471|141440754|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.6838|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Pain right now: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.5|-0.3|0.6838
70967121|NCT02187471|141440754|SUPERIORITY||Difference in least squares means|-0.791|STANDARD_ERROR_OF_MEAN|0.172|<|0.0001|TWO_SIDED|95.0|-1.129|-0.454|||ANCOVA|||Severity score: Placebo vs Pregabalin 150 mg BID||-0.454|-1.129|<0.0001
70967122|NCT02187471|141440754|SUPERIORITY||Difference in least squares means|-0.33|STANDARD_ERROR_OF_MEAN|0.1718||0.0552|TWO_SIDED|95.0|-0.667|0.007|||ANCOVA|||Severity score: Placebo vs DS-5565 15 mg QD||0.007|-0.667|0.0552
70967123|NCT02187471|141440754|SUPERIORITY||Difference in least squares means|-0.612|STANDARD_ERROR_OF_MEAN|0.1718||0.0004|TWO_SIDED|95.0|-0.95|-0.275|||ANCOVA|||Severity score: Placebo vs DS-5565 15 mg BID||-0.275|-0.950|0.0004
70967124|NCT02187471|141440754|SUPERIORITY||Difference in least squares means|0.462|STANDARD_ERROR_OF_MEAN|0.1729||0.0077|TWO_SIDED|95.0|0.122|0.801|||ANCOVA|||Severity score: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.801|0.122|0.0077
70967125|NCT02187471|141440754|SUPERIORITY||Difference in least squares means|0.179|STANDARD_ERROR_OF_MEAN|0.173||0.3014|TWO_SIDED|95.0|-0.161|0.518|||ANCOVA|||Severity score: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.518|-0.161|0.3014
70967126|NCT02187471|141440754|SUPERIORITY||Difference in least squares means|9.6|STANDARD_ERROR_OF_MEAN|2.4|<|0.0001|TWO_SIDED|95.0|4.9|14.3|||ANCOVA|||Relief (%) by treatment of pain: Placebo vs Pregabalin 150 mg BID||14.3|4.9|<0.0001
70967127|NCT02187471|141440754|SUPERIORITY||Difference in least squares means|8.5|STANDARD_ERROR_OF_MEAN|2.39||0.0004|TWO_SIDED|95.0|3.8|13.2|||ANCOVA|||Relief (%) by treatment of pain: Placebo vs DS-5565 15 mg QD||13.2|3.8|0.0004
70967128|NCT02187471|141440754|SUPERIORITY||Difference in least squares means|10.4|STANDARD_ERROR_OF_MEAN|2.39|<|0.0001|TWO_SIDED|95.0|5.7|15.1|||ANCOVA|||Relief (%) by treatment of pain: Placebo vs DS-5565 15 mg BID||15.1|5.7|<0.0001
70967129|NCT02187471|141440754|SUPERIORITY||Difference in least squares means|-1.1|STANDARD_ERROR_OF_MEAN|2.41||0.6449|TWO_SIDED|95.0|-5.8|3.6|||ANCOVA|||Relief (%) by treatment of pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||3.6|-5.8|0.6449
70967130|NCT02187471|141440754|SUPERIORITY||Difference in least square means|0.8|STANDARD_ERROR_OF_MEAN|2.41||0.734|TWO_SIDED|95.0|-3.9|5.5|||ANCOVA|||Relief (%) by treatment of pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||5.5|-3.9|0.7340
70967131|NCT02187471|141440755|SUPERIORITY||Difference in least squares means|-0.016|STANDARD_ERROR_OF_MEAN|0.0225||0.4816|TWO_SIDED|95.0|-0.06|0.028|||ANCOVA|||||0.028|-0.060|0.4816
70967132|NCT02187471|141440755|SUPERIORITY||Difference in least square means|-0.064|STANDARD_ERROR_OF_MEAN|0.0225||0.0044|TWO_SIDED|95.0|-0.109|-0.02|||ANCOVA|||||-0.020|-.109|0.0044
70967133|NCT02187471|141440755|SUPERIORITY||Difference in least squares means|-0.074|STANDARD_ERROR_OF_MEAN|0.0226||0.001|TWO_SIDED|95.0|-0.119|-0.03|||ANCOVA|||||-0.030|-0.119|0.0010
70967134|NCT02187471|141440755|SUPERIORITY||Difference in least squares means|0.059|STANDARD_ERROR_OF_MEAN|0.0226||0.0094|TWO_SIDED|95.0|0.014|0.103|||ANCOVA|||||0.103|0.014|0.0094
70967135|NCT02187471|141440755|SUPERIORITY||Difference in least squares means|0.01|STANDARD_ERROR_OF_MEAN|0.0226||0.6527|TWO_SIDED|95.0|-0.034|0.055|||ANCOVA|||||0.055|-0.034|0.6527
70967136|NCT01785160|141440757|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability (No formal testing was performed)|Adjusted Geometric Mean ratio|272.06|STANDARD_DEVIATION|67.9||0.9999||95.0|199.69|370.66||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Raltegravir plus Faldaprevir and Raltegravir for the category Raltegravir||370.66|199.69|0.9999
70967137|NCT01785160|141440758|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability(No formal testing was performed)|Adjusted Geometric Mean ratio|245.72|STANDARD_DEVIATION|87.1||0.9973||95.0|168.46|358.404||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Raltegravir plus Faldaprevir and Raltegravir for the category Raltegravir||358.404|168.460|0.9973
70967138|NCT02081534|141440768|SUPERIORITY|||||||0.012|||||||ANCOVA|||||||0.012
70967139|NCT02318667|141440777|OTHER|||||||0.0074|||||||t-test, 2 sided|||||||0.0074
70967140|NCT02318667|141440778|OTHER|||||||0.1506|||||||t-test, 2 sided|||||||0.1506
70967141|NCT04396860|141440791|SUPERIORITY||Hazard Ratio (HR)|1.47||||0.96|TWO_SIDED|95.0|0.98|2.21|||Log Rank|Stratified log-rank|Reference level = Arm 1|For the phase II endpoint, observation of 100 PFS events among the 150 randomized patients (from both arms) provides 95% statistical power to detect an improvement in median PFS from 5.7 months in the control arm to 9.7 months in the experimental arm, corresponding to a hazard reduction of 42% (hazard ratio 0.58) at one-sided significance level of 0.15 (and 87% power for hazard ratio of 0.65 at this same alpha).||2.21|0.98|0.96
70967142|NCT04223843|141440802|OTHER||Difference of adjusted means|0.336|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|0.246|0.425|||ANCOVA|Model included fixed categorical effects of treatment and the fixed continous effect of baseline FEV1 AUC0-3.|Difference = (Tio+Olo) - (Placebo)|H0: There is no difference in the mean FEV1 AUC0-3 change from baseline between Tio+Olo and matching placebo.||0.425|0.246|<0.0001
70967143|NCT04223843|141440802|OTHER||Difference of adjusted means|0.321|STANDARD_ERROR_OF_MEAN|0.044|<|0.0001|TWO_SIDED|95.0|0.233|0.409|||ANCOVA|Model included the fixed categorical effect of treatment and the fixed continuous effect of baseline FEV1 AUC0-3h.|Difference = (Tio+Olo) - (Placebo)|H0: There is no difference in the mean FEV1 AUC0-3h change from baseline between Tio+Olo and matching placebo.||0.409|0.233|<0.0001
70967144|NCT04223843|141440803|OTHER||Difference of adjusted means|0.201|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|0.117|0.286|||Mixed Models Analysis|Mixed model with repeated measures including fixed categorial effect of treatment at each visit and fixed continuous effect of baseline at each visit.|Difference = (Tio+Olo) - (Placebo)|H0: There is no difference in the mean trough FEV1 change from baseline between Tio+Olo and matching placebo.||0.286|0.117|<0.0001
70967145|NCT04223843|141440803|OTHER||Difference of adjusted means|0.217|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.135|0.299|||Mixed Models Analysis|Mixed model with repeated measures including fixed categorial effect of treatment at each visit and fixed continuous effect of baseline at each visit.|Difference = (Tio+Olo) - (Placebo)|H0: There is no difference in the mean trough FEV1 change from baseline between Tio+Olo and matching placebo.||0.299|0.135|<0.0001
70967146|NCT02636582|141440812|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||||||0.71
70967147|NCT02636582|141440813|SUPERIORITY|||||||0.964|||||||Wilcoxon (Mann-Whitney)|||||||0.964
70967148|NCT02636582|141440814|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
70967149|NCT02636582|141440815|OTHER|||||||0.172||||||HER2 expression - biopsy|Fisher Exact|||||||0.172
70967150|NCT02636582|141440815|OTHER|||||||0.38||||||HER2 expression - resection|Fisher Exact|||||||0.38
70967151|NCT01263483|141440822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.002|||||TWO_SIDED|95.0|-1.166|-0.838||||||||-0.838|-1.166|
70967152|NCT01263483|141440822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.947|||||TWO_SIDED|95.0|-1.097|-0.796||||||||-0.796|-1.097|
70967153|NCT01263483|141440823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.176|||||TWO_SIDED|95.0|-0.229|-0.123||||||||-0.123|-0.229|
70967154|NCT01263483|141440823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-0.247|-0.133||||||||-0.133|-0.247|
70967155|NCT01263483|141440824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.421|||||TWO_SIDED|95.0|-0.507|-0.334||||||||-0.334|-0.507|
70967156|NCT01263483|141440824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.414|||||TWO_SIDED|95.0|-0.504|-0.324||||||||-0.324|-0.504|
70967157|NCT01263483|141440825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.738|||||TWO_SIDED|95.0|-0.871|-0.605||||||||-0.605|-0.871|
70967158|NCT01263483|141440825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.749|||||TWO_SIDED|95.0|-0.875|-0.623||||||||-0.623|-0.875|
70967159|NCT01263483|141440826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.01|||||TWO_SIDED|95.0|-18.5|-5.52||||||||-5.52|-18.50|
70967160|NCT01263483|141440826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.33|||||TWO_SIDED|95.0|-21.93|-8.73||||||||-8.73|-21.93|
70967161|NCT01263483|141440827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.65|||||TWO_SIDED|95.0|-23.02|-8.27||||||||-8.27|-23.02|
70967162|NCT01263483|141440827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.03|||||TWO_SIDED|95.0|-29.68|-14.38||||||||-14.38|-29.68|
70967163|NCT01263483|141440828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.3|||||TWO_SIDED|95.0|-26.09|-10.5||||||||-10.50|-26.09|
70967164|NCT01263483|141440828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.34|||||TWO_SIDED|95.0|-27.34|-11.34||||||||-11.34|-27.34|
70967165|NCT01263483|141440829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.53|||||TWO_SIDED|95.0|-21.46|-5.6||||||||-5.60|-21.46|
70967166|NCT01263483|141440829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.97|||||TWO_SIDED|95.0|-21.53|-4.41||||||||-4.41|-21.53|
70967167|NCT01263483|141440830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.304|0.104||||||||0.104|-0.304|
70967168|NCT01263483|141440830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.036|||||TWO_SIDED|95.0|-0.239|0.167||||||||0.167|-0.239|
70967169|NCT01263483|141440831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.013|||||TWO_SIDED|95.0|-0.267|0.292||||||||0.292|-0.267|
70967170|NCT01263483|141440831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.034|||||TWO_SIDED|95.0|-0.264|0.196||||||||0.196|-0.264|
70967171|NCT01263483|141440832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.038|||||TWO_SIDED|95.0|-0.268|0.191||||||||0.191|-0.268|
70967172|NCT01263483|141440832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.073|||||TWO_SIDED|95.0|-0.261|0.115||||||||0.115|-0.261|
70967173|NCT01263483|141440833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|||||TWO_SIDED|95.0|-0.183|0.252||||||||0.252|-0.183|
70967174|NCT01263483|141440833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|||||TWO_SIDED|95.0|-0.124|0.288||||||||0.288|-0.124|
70967175|NCT01263483|141440834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.54|||||TWO_SIDED|95.0|-41.28|-21.8||||||||-21.80|-41.28|
70967176|NCT01263483|141440834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.73|||||TWO_SIDED|95.0|-44.88|-22.57||||||||-22.57|-44.88|
70967177|NCT01263483|141440835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-70.38|||||TWO_SIDED|95.0|-90.67|-50.09||||||||-50.09|-90.67|
70967178|NCT01263483|141440835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-72.49|||||TWO_SIDED|95.0|-93.1|-51.88||||||||-51.88|-93.10|
70967179|NCT01263483|141440836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.093|||||TWO_SIDED|95.0|2.229|11.958||||||||11.958|2.229|
70967180|NCT01263483|141440836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.967|||||TWO_SIDED|95.0|-0.521|8.455||||||||8.455|-0.521|
70967181|NCT01263483|141440837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55|||||TWO_SIDED|95.0|-0.045|1.144||||||||1.144|-0.045|
70967182|NCT01263483|141440837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.428|||||TWO_SIDED|95.0|-0.233|1.09||||||||1.090|-0.233|
70967183|NCT01263483|141440838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.77|||||TWO_SIDED|95.0|-36.65|-0.9||||||||-0.90|-36.65|
70967184|NCT01263483|141440838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.04|||||TWO_SIDED|95.0|-37.82|-2.27||||||||-2.27|-37.82|
70967185|NCT01372384|141440855|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED||||||"Clopper-Pearson exact method"|||Response assessment of Stable Disease Vs Partial Response at Visit 4 (Two proportions for Stable Disease Vs Partial Response of Erlotinib): The observed significance value of performed test for differences between two proportions for Stable Disease Vs Partial Response was analyzed.||||0.045
70967186|NCT01372384|141440855|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||"Clopper-Pearson exact method"|||Response assessment of Stable Disease Vs Partial Response at Visit 6 (Two proportions for Stable Disease Vs Partial Response of Erlotinib): The observed significance value of performed test for differences between two proportions for Stable Disease Vs Partial Response was analyzed||||1.000
70967187|NCT01372384|141440855|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||"Clopper-Pearson exact method"|||Response assessment of Partial Response Vs Progression of disease at Visit 6 (Two proportions for of Partial Response Vs Progression of disease of Erlotinib): The observed significance value of performed test for differences between two proportions for of Partial Response Vs Progression of disease was analyzed||||1.000
70967188|NCT01372384|141440855|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||"Clopper-Pearson exact method"|||Response assessment of Stable Disease Vs Progression of disease at Visit 6 (Two proportions for of Stable Disease Vs Progression of disease of Erlotinib): The observed significance value of performed test for differences between two proportions for of Stable Disease Vs Progression of disease was analyzed||||1.000
70967189|NCT01372384|141440855|SUPERIORITY_OR_OTHER|||||||0.274|TWO_SIDED||||||"Clopper-Pearson exact method"|||Response assessment of Partial Response Vs Progression of disease at Visit 10 (Two proportions for of Partial Response Vs Progression of disease of Erlotinib): The observed significance value of performed test for differences between two proportions for of Partial Response Vs Progression of disease was analyzed||||0.274
70967190|NCT01131676|141440862|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was chosen as 1.3 based on Food and Drug Administration (FDA) Guidance for Industry - Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes|Hazard Ratio (HR)|0.86|||<|0.0001|TWO_SIDED|95.02|0.74|0.99||One-sided test with alpha = 0.0249|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|Primary objective was to establish the non-inferiority of All empagliflozin relative to placebo for time to first 3-point MACE. A 4-step hierarchical testing strategy was followed for the non-inferiority test of the primary endpoint and then the key secondary endpoint, each at a margin of 1.3, followed by test of superiority of primary and key secondary endpoints.||0.99|0.74|<0.0001
70967191|NCT01131676|141440862|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.0382|TWO_SIDED|95.02|0.74|0.99||Two-sided test with alpha=0.0498|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|||0.99|0.74|0.0382
70967192|NCT01131676|141440863|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was chosen as 1.3 based on Food and Drug Administration (FDA) Guidance for Industry - Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes|Hazard Ratio (HR)|0.89|||<|0.0001|TWO_SIDED|95.02|0.78|1.01||One-sided test with alpha = 0.0249|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|A 4-step hierarchical testing strategy was followed for the non-inferiority test of the primary endpoint and then the key secondary endpoint, each at a margin of 1.3, followed by test of superiority of primary and key secondary endpoints.||1.01|0.78|<0.0001
70967193|NCT01131676|141440863|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.0795|TWO_SIDED|95.02|0.78|1.01||Two-sided test with alpha=0.0498|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|A 4-step hierarchical testing strategy was followed for the non-inferiority test of the primary endpoint and then the key secondary endpoint, each at a margin of 1.3, followed by test of superiority of primary and key secondary endpoints.||1.01|0.78|0.0795
70967194|NCT01131676|141440864|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.28||||0.4172|TWO_SIDED|95.0|0.7|2.33||Two-sided test with alpha = 0.05.|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|||2.33|0.70|0.4172
70967195|NCT01131676|141440865|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.0017|TWO_SIDED|95.0|0.5|0.85||Two-sided test with alpha = 0.05.|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|||0.85|0.50|0.0017
70967196|NCT01131676|141440866|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.2547|TWO_SIDED|95.0|0.87|1.04||Two-sided test with alpha = 0.05.|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|||1.04|0.87|0.2547
70967197|NCT01131676|141440867|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.54|0.72||Two-sided test with alpha = 0.05.|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|||0.72|0.54|<0.0001
70967198|NCT01131676|141440868|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.54|0.7||Two-sided test with alpha = 0.05.|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|||0.70|0.54|<0.0001
70967199|NCT01961349|141440869|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
70967200|NCT01961349|141440869|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
70967201|NCT01961349|141440870|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
70967202|NCT01961349|141440870|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
70967203|NCT00896779|141440871|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||||||0.02
70967204|NCT00896779|141440871|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||t-test, 2 sided|||||||0.06
70967205|NCT00829179|141440872|SUPERIORITY_OR_OTHER||Difference in Mean|11.0|STANDARD_DEVIATION|13.3||0.005||95.0|||||Sign test|||||||0.005
70967206|NCT01431274|141440909|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.123|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.1|0.146||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.146|0.100|<0.0001
70904368|NCT03573908|141297252|SUPERIORITY||LS mean difference|-0.768|||<|0.0001|TWO_SIDED|95.0|-1.076|-0.46||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 5. Not part of the fixed-sequence testing procedure.||-0.460|-1.076|< 0.0001
70967207|NCT01431274|141440909|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.117|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001||95.0|0.094|0.14||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.140|0.094|<0.0001
70967208|NCT01431274|141440909|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.109|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.086|0.132||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.132|0.086|<0.0001
70967209|NCT01431274|141440909|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.093|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.07|0.116||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.116|0.070|<0.0001
70967210|NCT01431274|141440909|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.102|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.08|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.125|0.080|<0.0001
70967211|NCT01431274|141440909|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.014|STANDARD_ERROR_OF_MEAN|0.012||0.2169|TWO_SIDED|95.0|-0.008|0.037||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.037|-0.008|0.2169
70967212|NCT01431274|141440909|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.108|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.085|0.13||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.130|0.085|<0.0001
70967213|NCT01431274|141440909|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.006|STANDARD_ERROR_OF_MEAN|0.012||0.5849|TWO_SIDED|95.0|-0.017|0.029||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.029|-0.017|0.5849
70967214|NCT01431274|141440909|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.016|STANDARD_ERROR_OF_MEAN|0.012||0.1863|TWO_SIDED|95.0|-0.007|0.039||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.039|-0.007|0.1863
70967215|NCT01431274|141440909|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.009|STANDARD_ERROR_OF_MEAN|0.012||0.4352|TWO_SIDED|95.0|-0.032|0.014||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.014|-0.032|0.4352
70967216|NCT01431274|141440910|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.082|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.059|0.106||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.106|0.059|<.0001
70967217|NCT01431274|141440910|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.047|0.094||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.094|0.047|<0.0001
70967218|NCT01431274|141440910|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.058|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.034|0.081||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.081|0.034|<0.0001
70967219|NCT01431274|141440910|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.029|STANDARD_ERROR_OF_MEAN|0.012||0.0174|TWO_SIDED|95.0|0.005|0.052||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.052|0.005|0.0174
70967220|NCT01431274|141440910|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.046|STANDARD_ERROR_OF_MEAN|0.012||0.0001|TWO_SIDED|95.0|0.023|0.07||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.070|0.023|0.0001
70967221|NCT01431274|141440910|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.024|STANDARD_ERROR_OF_MEAN|0.012||0.0407|TWO_SIDED|95.0|0.001|0.048||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.048|0.001|0.0407
70967222|NCT01431274|141440910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.03|0.077||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.077|0.030|<0.0001
70967223|NCT01431274|141440910|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.012||0.3326|TWO_SIDED|95.0|-0.012|0.035||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.035|-0.012|0.3326
70967224|NCT01431274|141440910|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.029|STANDARD_ERROR_OF_MEAN|0.012||0.0151|TWO_SIDED|95.0|0.006|0.053||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.053|0.006|0.0151
70967225|NCT01431274|141440910|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.018|STANDARD_ERROR_OF_MEAN|0.012||0.1421|TWO_SIDED|95.0|-0.041|0.006||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.006|-0.041|0.1421
70904369|NCT03573908|141297252|SUPERIORITY||LS mean difference|-0.758|||<|0.0001|TWO_SIDED|95.0|-1.086|-0.431||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 7. Not part of the fixed-sequence testing procedure.||-0.431|-1.086|< 0.0001
70967226|NCT01431274|141440911|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.693|STANDARD_ERROR_OF_MEAN|0.553||0.0022|TWO_SIDED|95.0|-2.778|-0.608||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||-0.608|-2.778|0.0022
70967227|NCT01431274|141440911|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.233|STANDARD_ERROR_OF_MEAN|0.551||0.0252|TWO_SIDED|95.0|-2.313|-0.153||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||-0.153|-2.313|0.0252
70967228|NCT01431274|141440911|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.031|STANDARD_ERROR_OF_MEAN|0.552||0.062|TWO_SIDED|95.0|-2.113|0.052||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.052|-2.113|0.0620
70967229|NCT01431274|141440911|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.456|STANDARD_ERROR_OF_MEAN|0.548||0.4051|TWO_SIDED|95.0|-1.531|0.618||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.618|-1.531|0.4051
70967230|NCT01431274|141440911|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.571|STANDARD_ERROR_OF_MEAN|0.55||0.2988|TWO_SIDED|95.0|-1.649|0.507||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.507|-1.649|0.2988
70967231|NCT01431274|141440911|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.662|STANDARD_ERROR_OF_MEAN|0.545||0.2249|TWO_SIDED|95.0|-1.731|0.407||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.407|-1.731|0.2249
70967232|NCT01431274|141440911|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.118|STANDARD_ERROR_OF_MEAN|0.549||0.0418|TWO_SIDED|95.0|-2.195|-0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||-0.042|-2.195|0.0418
70967233|NCT01431274|141440911|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.557||0.4097|TWO_SIDED|95.0|-1.552|0.633||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg)~Spatial power covariance structure for within-patient errors."|||0.633|-1.552|0.4097
70967234|NCT01431274|141440911|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.575|STANDARD_ERROR_OF_MEAN|0.556||0.3013|TWO_SIDED|95.0|-1.664|0.515||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.515|-1.664|0.3013
70967235|NCT01431274|141440911|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.115|STANDARD_ERROR_OF_MEAN|0.554||0.8355|TWO_SIDED|95.0|-0.97|1.2||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||1.200|-0.970|0.8355
70967236|NCT01431274|141440912|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.135||0.0019|TWO_SIDED|95.0|0.155|0.684||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.684|0.155|0.0019
70967237|NCT01431274|141440912|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.356|STANDARD_ERROR_OF_MEAN|0.135||0.0082|TWO_SIDED|95.0|0.092|0.619||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.619|0.092|0.0082
70967238|NCT01431274|141440912|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.416|STANDARD_ERROR_OF_MEAN|0.135||0.002|TWO_SIDED|95.0|0.152|0.681||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.681|0.152|0.0020
70967239|NCT01431274|141440912|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.134||0.0307|TWO_SIDED|95.0|0.027|0.554||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.554|0.027|0.0307
70967240|NCT01431274|141440912|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.352|STANDARD_ERROR_OF_MEAN|0.135||0.0088|TWO_SIDED|95.0|0.089|0.616||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.616|0.089|0.0088
70904370|NCT03573908|141297252|SUPERIORITY||LS mean difference|-0.703|||<|0.0001|TWO_SIDED|95.0|-1.043|-0.363||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 9. Not part of the fixed-sequence testing procedure.||-0.363|-1.043|< 0.0001
70904371|NCT03573908|141297252|SUPERIORITY||LS mean difference|-0.844|||<|0.0001|TWO_SIDED|95.0|-1.189|-0.498||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 11. Not part of the fixed-sequence testing procedure.||-0.498|-1.189|< 0.0001
70904372|NCT04466215|141297253|SUPERIORITY||Slope|-0.063|STANDARD_ERROR_OF_MEAN|0.04||0.065|TWO_SIDED|||||One-tail test of directional hypothesis.|Mixed Models Analysis|||Mixed effect model with directional hypothesis that drug reduces strength of craving (VAS). Principle predictor was drug plasma concentration. Arms were combined for this analysis.||||.065
70904373|NCT00926003|141297257|SUPERIORITY|||||||0.02|||||||ANCOVA|||Least Square Means from Longitudinal Model, Their Standard Errors by Trial Arm Adjusted for Age, Being on ART at Intake, Socioeconomic Score, Home Score, Recruitment Location, KABC Learning and Delayed Recall Scores at Baseline, and Outcome Score at Baseline||||0.02
70904374|NCT00926003|141297258|SUPERIORITY|||||||0.18|||||||ANCOVA|||Least Square Means from Longitudinal Model, Their Standard Errors by Trial Arm Adjusted for Age, Being on ARV at Intake, Socioeconomic Score, Home Score, Recruitment Location, KABC Learning and Delayed Recall Scores at Baseline, and Outcome Score at Baseline||||0.18
70904375|NCT02708433|141297292|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|49.0||0.74|TWO_SIDED|95.0|-0.49|0.57|||Wilcoxon (Mann-Whitney)|||||0.57|-0.49|0.74
70904376|NCT02708433|141297293|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|48.0||0.5|TWO_SIDED|95.0|-0.89|0.52|||Wilcoxon (Mann-Whitney)|||||0.52|-0.89|0.5
70904377|NCT00552786|141297400|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Two-sided|ANOVA|Assessing the bioequivalence on temporary threshold shift at3k,4k,6k Hz between NAC and Placebo was carried out using ANOVA for 2×2 crossover design.||||||<0.05
70904378|NCT00552786|141297401|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|Assessing the bioequivalence on temporary threshold shift at 3k,4k,6k Hz between NAC and Placebo was carried out using ANOVA for 2×2 crossover design.||||||<0.05
70904379|NCT03549234|141297403|NON_INFERIORITY|"We tested the noninferiority of ESPB compared to PVB (paravertebral block) using the 95% confidence interval (CI) associated with the Wilcoxon-Mann-Whitney Exact test. If the lower limit of the 95% CI for median average recovery room pain scores was greater than -1.25 (based on PVB minus ESPB), we concluded noninferiority. The noninferiority of ESPBs with regard to opioid consumption was similarly tested with a predefined noninferiority margin of 2 mg intravenous morphine equivalents."||||||0.0011|||||||Wilcoxon (Mann-Whitney)|||We hypothesized that 1) analgesia would be noninferior in the recovery room as measured on a Numeric Rating Scale with ESPB (erector spinae plane block), and 2) opioid consumption would be noninferior in the operating and recovery rooms with ESPB. We simulated pain scores from a discrete distribution with median (interquartile range) 2 (0-3). The sample size of 50 per group provided 81% power to detect noninferiority in pain.||||0.0011
70904380|NCT03549234|141297404|NON_INFERIORITY|"We tested the noninferiority of ESPB compared to PVB using the 95% confidence interval (CI) associated with the Wilcoxon-Mann-Whitney Exact test. If the lower limit of the 95% CI for median average recovery room pain scores was greater than -1.25 (based on PVB minus ESPB), we concluded noninferiority. The noninferiority of ESPBs with regard to opioid consumption was similarly tested with a predefined noninferiority margin of 2 mg intravenous morphine equivalents."||||||0.0043|||||||Wilcoxon (Mann-Whitney)|||||||0.0043
70904381|NCT00856934|141297419|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||||||0.05
70904382|NCT00856934|141297420|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||||||0.05
70904383|NCT01015807|141297440|OTHER|||||||0.48|||||||ANOVA|||We estimated that 25 subjects per group would allow us to detect a reduction of this area from 7.5 cm2 in our placebo group to 3.5 cm2 in the CloTAP group, with SD = 5 cm2 in both groups, owing to improved overall analgesia and reduced pain sensitization in women allocated to receive a TAP block with clonidine (2-tailed \[alpha\] = 0.05, 80% power). To allow for failed TAP blocks and/or exclusions of cases, we included 30 patients per group (n = 90)||||0.48
70904384|NCT00244374|141297490|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.05|TWO_SIDED|95.0|0.8|2.44|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the past 3 months as a risk factor for used (injected/snorted/smoked) heroin in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||2.44|0.80|0.05
70904385|NCT00244374|141297490|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.76||||0.01|TWO_SIDED|95.0|1.12|2.76|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the past 3 months as a risk factor for having Used (injected/snorted/smoked) powder cocaine in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||2.76|1.12|0.01
70904386|NCT00244374|141297490|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.05|TWO_SIDED|95.0|1.0|2.44|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the prior 3 months as a risk factor for having Used (injected and/or snorted) crack cocaine in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||2.44|1.00|0.05
70904387|NCT00244374|141297490|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.03|TWO_SIDED|95.0|0.35|0.98|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the prior 3 months as a risk factor for having Used (injected/snorted/smoked) methamphetamine in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||0.98|0.35|0.03
70904388|NCT00244374|141297490|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.99|||<|0.01|TWO_SIDED|95.0|1.11|3.59|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the prior 3 months as a risk factor for poly-substance use in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||3.59|1.11|<0.01
70904389|NCT00244374|141297490|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.87|||<|0.01|TWO_SIDED|95.0|3.84|12.28|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the prior 3 months as a risk factor for Heavy drinking (\>14 and \>21 drinks/week for women and men respectively) in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||12.28|3.84|<0.01
70967241|NCT01431274|141440912|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.003|STANDARD_ERROR_OF_MEAN|0.134||0.9801|TWO_SIDED|95.0|-0.259|0.266||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.266|-0.259|0.9801
70967242|NCT01431274|141440912|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.294|STANDARD_ERROR_OF_MEAN|0.134||0.0289|TWO_SIDED|95.0|0.03|0.557||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.557|0.030|0.0289
70967243|NCT01431274|141440912|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.136||0.6382|TWO_SIDED|95.0|-0.202|0.33||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.330|-0.202|0.6382
70967244|NCT01431274|141440912|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.126|STANDARD_ERROR_OF_MEAN|0.135||0.3525|TWO_SIDED|95.0|-0.14|0.391||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.391|-0.140|0.3525
70967245|NCT01431274|141440912|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.062|STANDARD_ERROR_OF_MEAN|0.135||0.6457|TWO_SIDED|95.0|-0.327|0.203||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.203|-0.327|0.6457
70967246|NCT01431274|141440913|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.033|STANDARD_ERROR_OF_MEAN|0.012||0.0067|TWO_SIDED|95.0|0.009|0.056||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.056|0.009|0.0067
70967247|NCT01431274|141440913|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.081|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.057|0.104||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.104|0.057|<0.0001
70967248|NCT01431274|141440913|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.022|STANDARD_ERROR_OF_MEAN|0.012||0.0746|TWO_SIDED|95.0|-0.002|0.045||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.045|-0.002|0.0746
70967249|NCT01431274|141440913|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.078|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.054|0.101||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.101|0.054|<0.0001
70967250|NCT01431274|141440913|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.046|0.093||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.093|0.046|<0.0001
70967251|NCT01431274|141440913|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.011|STANDARD_ERROR_OF_MEAN|0.012||0.3549|TWO_SIDED|95.0|-0.013|0.035||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.035|-0.013|0.3549
70967252|NCT01431274|141440913|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.089|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.065|0.113||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.113|0.065|<0.0001
70967253|NCT01431274|141440913|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.048|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|-0.072|-0.025||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||-0.025|-0.072|<0.0001
70967254|NCT01431274|141440913|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.056|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|-0.08|-0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||-0.033|-0.080|<0.0001
70967255|NCT01431274|141440913|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.008|STANDARD_ERROR_OF_MEAN|0.012||0.5018|TWO_SIDED|95.0|-0.016|0.032||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.032|-0.016|0.5018
70967256|NCT01431274|141440914|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.128|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.104|0.152||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.152|0.104|<0.0001
70967257|NCT01431274|141440914|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.126|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.102|0.15||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.150|0.102|<0.0001
70967258|NCT01431274|141440914|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.111|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.087|0.135||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.135|0.087|<0.0001
70967259|NCT01431274|141440914|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.096|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.072|0.12||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.120|0.072|<0.0001
70967260|NCT01431274|141440914|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.109|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.085|0.133||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.133|0.085|<0.0001
70967261|NCT01431274|141440914|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.017|STANDARD_ERROR_OF_MEAN|0.012||0.1569|TWO_SIDED|95.0|-0.007|0.041||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.041|-0.007|0.1569
70967262|NCT01431274|141440914|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.113|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.089|0.137||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.137|0.089|<0.0001
70967263|NCT01431274|141440914|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.002|STANDARD_ERROR_OF_MEAN|0.012||0.8834|TWO_SIDED|95.0|-0.022|0.026||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.026|-0.022|0.8834
70967264|NCT01431274|141440914|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.015|STANDARD_ERROR_OF_MEAN|0.012||0.2129|TWO_SIDED|95.0|-0.009|0.039||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.039|-0.009|0.2129
70967265|NCT01431274|141440914|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.013|STANDARD_ERROR_OF_MEAN|0.012||0.2702|TWO_SIDED|95.0|-0.037|0.01||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.010|-0.037|0.2702
70967266|NCT01431274|141440915|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.141|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.117|0.166||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.166|0.117|<0.0001
70967267|NCT01431274|141440915|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.115|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.09|0.139||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.139|0.090|<0.0001
70967268|NCT01431274|141440915|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.119|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.094|0.143||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.143|0.094|<0.0001
70967269|NCT01431274|141440915|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.099|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.074|0.123||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.123|0.074|<0.0001
70967270|NCT01431274|141440915|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.092|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.067|0.117||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.117|0.067|<0.0001
70967271|NCT01431274|141440915|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.023|STANDARD_ERROR_OF_MEAN|0.013||0.0717|TWO_SIDED|95.0|-0.002|0.047||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.047|-0.002|0.0717
70967272|NCT01431274|141440915|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.121|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.097|0.146||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.146|0.097|<0.0001
70967273|NCT01431274|141440915|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.027|STANDARD_ERROR_OF_MEAN|0.013||0.0344|TWO_SIDED|95.0|0.002|0.051||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.051|0.002|0.0344
70967274|NCT01431274|141440915|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.013||0.1126|TWO_SIDED|95.0|-0.005|0.045||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.045|-0.005|0.1126
70967275|NCT01431274|141440915|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.007|STANDARD_ERROR_OF_MEAN|0.013||0.6009|TWO_SIDED|95.0|-0.018|0.031||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.031|-0.018|0.6009
70967276|NCT01431274|141440916|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.072|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.049|0.096||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.096|0.049|<0.0001
70967277|NCT01431274|141440916|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.039|0.087||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.087|0.039|<0.0001
70967278|NCT01431274|141440916|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.012||0.0001|TWO_SIDED|95.0|0.023|0.07||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.070|0.023|0.0001
70967279|NCT01431274|141440916|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.012||0.0122|TWO_SIDED|95.0|0.007|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.054|0.007|0.0122
70967280|NCT01431274|141440916|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.037|STANDARD_ERROR_OF_MEAN|0.012||0.0021|TWO_SIDED|95.0|0.014|0.061||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.061|0.014|0.0021
70967281|NCT01431274|141440916|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.026|STANDARD_ERROR_OF_MEAN|0.012||0.0347|TWO_SIDED|95.0|0.002|0.049||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.049|0.002|0.0347
70967282|NCT01431274|141440916|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.056|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.032|0.08||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.080|0.032|<0.0001
70967283|NCT01431274|141440916|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.009|STANDARD_ERROR_OF_MEAN|0.012||0.4407|TWO_SIDED|95.0|-0.014|0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.033|-0.014|0.4407
70967284|NCT01431274|141440916|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.016|STANDARD_ERROR_OF_MEAN|0.012||0.1777|TWO_SIDED|95.0|-0.007|0.04||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.040|-0.007|0.1777
70967285|NCT01431274|141440916|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.007|STANDARD_ERROR_OF_MEAN|0.012||0.5641|TWO_SIDED|95.0|-0.031|0.017||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.017|-0.031|0.5641
70967286|NCT01431274|141440917|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.057|0.104||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.104|0.057|<0.0001
70967287|NCT01431274|141440917|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.075|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.051|0.099||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.099|0.051|<0.0001
70967288|NCT01431274|141440917|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.038|STANDARD_ERROR_OF_MEAN|0.012||0.0018|TWO_SIDED|95.0|0.014|0.062||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.062|0.014|0.0018
70967289|NCT01431274|141440917|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.024|STANDARD_ERROR_OF_MEAN|0.012||0.0517|TWO_SIDED|95.0|0.0|0.047||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.047|-0.000|0.0517
70967290|NCT01431274|141440917|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.033|STANDARD_ERROR_OF_MEAN|0.012||0.0072|TWO_SIDED|95.0|0.009|0.056||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.056|0.009|0.0072
70967291|NCT01431274|141440917|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.042|STANDARD_ERROR_OF_MEAN|0.012||0.0005|TWO_SIDED|95.0|0.019|0.066||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.066|0.019|0.0005
70967292|NCT01431274|141440917|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.066|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.042|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.090|0.042|<0.0001
70967293|NCT01431274|141440917|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.005|STANDARD_ERROR_OF_MEAN|0.012||0.6619|TWO_SIDED|95.0|-0.018|0.029||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.029|-0.018|0.6619
70967294|NCT01431274|141440917|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.014|STANDARD_ERROR_OF_MEAN|0.012||0.2401|TWO_SIDED|95.0|-0.01|0.038||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.038|-0.010|0.2401
70967295|NCT01431274|141440917|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.009|STANDARD_ERROR_OF_MEAN|0.012||0.4601|TWO_SIDED|95.0|-0.033|0.015||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.015|-0.033|0.4601
70967296|NCT01431274|141440918|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.088|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.064|0.112||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.112|0.064|<0.0001
70967297|NCT01431274|141440918|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.052|0.1||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.100|0.052|<0.0001
70967298|NCT01431274|141440918|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.046|0.094||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.094|0.046|<0.0001
70967299|NCT01431274|141440918|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.051|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.027|0.075||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.075|0.027|<0.0001
70967300|NCT01431274|141440918|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.058|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.034|0.082||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.082|0.034|<0.0001
70967301|NCT01431274|141440918|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.018|STANDARD_ERROR_OF_MEAN|0.012||0.1405|TWO_SIDED|95.0|-0.006|0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.042|-0.006|0.1405
70967302|NCT01431274|141440918|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.069|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.045|0.093||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.093|0.045|<0.0001
70967303|NCT01431274|141440918|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.012||0.3118|TWO_SIDED|95.0|-0.012|0.036||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.036|-0.012|0.3118
70967304|NCT01431274|141440918|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.019|STANDARD_ERROR_OF_MEAN|0.012||0.1171|TWO_SIDED|95.0|-0.005|0.043||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.043|-0.005|0.1171
70967305|NCT01431274|141440918|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.007|STANDARD_ERROR_OF_MEAN|0.012||0.5759|TWO_SIDED|95.0|-0.031|0.017||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.017|-0.031|0.5759
70967306|NCT01431274|141440919|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.079|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.055|0.103||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.103|0.055|<0.0001
70967307|NCT01431274|141440919|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.062|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.038|0.086||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.086|0.038|<0.0001
70967308|NCT01431274|141440919|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.061|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.037|0.085||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.085|0.037|<0.0001
70967309|NCT01431274|141440919|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.012||0.0002|TWO_SIDED|95.0|0.022|0.071||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.071|0.022|0.0002
70967310|NCT01431274|141440919|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.044|STANDARD_ERROR_OF_MEAN|0.012||0.0004|TWO_SIDED|95.0|0.019|0.068||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.068|0.019|0.0004
70967311|NCT01431274|141440919|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.018|STANDARD_ERROR_OF_MEAN|0.012||0.136|TWO_SIDED|95.0|-0.006|0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.042|-0.006|0.1360
70967312|NCT01431274|141440919|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.041|0.089||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.089|0.041|<0.0001
70967313|NCT01431274|141440919|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.017|STANDARD_ERROR_OF_MEAN|0.012||0.1617|TWO_SIDED|95.0|-0.007|0.041||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.041|-0.007|0.1617
70967314|NCT01431274|141440919|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.014|STANDARD_ERROR_OF_MEAN|0.012||0.2476|TWO_SIDED|95.0|-0.01|0.039||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.039|-0.010|0.2476
70967315|NCT01431274|141440919|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.003|STANDARD_ERROR_OF_MEAN|0.012||0.8083|TWO_SIDED|95.0|-0.021|0.027||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.027|-0.021|0.8083
70967316|NCT01431274|141440920|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.075|0.124||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.124|0.075|<0.0001
70967317|NCT01431274|141440920|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.039|0.088||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.088|0.039|<0.0001
70904390|NCT00244374|141297490|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.63|||<|0.01|TWO_SIDED|95.0|2.02|6.5|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in the prior 3 months as a risk factor for Drank until blacked out in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||6.50|2.02|<0.01
70904391|NCT00244374|141297490|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.04|TWO_SIDED|95.0|0.33|0.93|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in the prior 3 months as a risk factor for Injected daily, past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||0.93|0.33|0.04
70904392|NCT00244374|141297490|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.16|||<|0.01|TWO_SIDED|95.0|1.37|3.4|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in the prior 3 months as a risk factor for Median number of injected partners \>= 5 in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||3.40|1.37|<0.01
70904393|NCT00244374|141297490|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.19|TWO_SIDED|95.0|0.81|1.97|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having Lent a needle/syringe in the past 30 days|Adjusted odds with 95% confidence interval for travel in the prior 3 months as a risk factor for having Lent a needle/syringe in the past 30 days||1.97|0.81|0.19
70904394|NCT00244374|141297490|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61|||<|0.01|TWO_SIDED|95.0|1.01|2.55|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having Injected with someone else's used needle/syringe in the past 30 days|Adjusted odds ratio with 95 % confidence interval for travel in prior 3 months as a risk factor for having injected with someone else's used needle/syringe in the past 30 days||2.55|1.01|<0.01
70904395|NCT00244374|141297490|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.07|||<|0.01|TWO_SIDED|95.0|1.79|5.27|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having Pooled money to buy drugs in the past 30 days|Adjusted odds with 95% confidence interval for travel in the prior 3 months as a risk factor for having Pooled money to buy drugs in the past 30 days||5.27|1.79|<0.01
70904396|NCT00244374|141297490|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||<|0.01|TWO_SIDED|95.0|1.34|3.32|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having Shared cooker/spook to prepare drugs in the past 30 days|Adjusted odds ratios with 95% confidence interval for travel in prior 3 months as risk factor for risk behaviors||3.32|1.34|<0.01
70904397|NCT00244374|141297490|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87|||<|0.01|TWO_SIDED|95.0|1.19|2.95|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having used Backloaded Syringe in the past 30 days|Adjusted odds with 95 % confidence interval for travel as a risk factor for risk behaviors||2.95|1.19|<0.01
70904398|NCT00244374|141297490|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.13|TWO_SIDED|95.0|0.83|2.1|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|"Adjusted odds for travel in prior 3 months as a risk factor for having done Someone's rinse in the past 30 days"|Adjusted odds with 95% confidence interval for travel in prior 3 months as a risk factor for risk behavior in past 30 days||2.10|0.83|0.13
70904399|NCT00244374|141297490|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21|||<|0.01|TWO_SIDED|95.0|1.4|3.49|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for Median number of sexual partners \>=2 in the past 30 days|Adjusted odds ratios and 95% confidence intervals for travel in prior 3 months as a risk factor for risk behaviors in past 30 days||3.49|1.40|<0.01
70904400|NCT00244374|141297490|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.86|TWO_SIDED|95.0|0.45|1.85|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having Traded sex for money or drugs in the past 30 days|Adjusted odds and 95% confidence interval for travel in prior 3 months as a risk factor for risk behaviors in past 30 days||1.85|0.45|0.86
70904401|NCT00244374|141297490|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.73|TWO_SIDED|95.0|0.59|2.02|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for condom use \>90% (if sexually active)|Adjusted odds and 95% confidence interval for travel in prior 3 months as a risk factor for engaging in risk behavior during the past 30 days||2.02|0.59|0.73
70904402|NCT01486758|141297510|SUPERIORITY_OR_OTHER|||||||0.6|||||||ANCOVA|||||||0.6
70904403|NCT01486758|141297514|SUPERIORITY_OR_OTHER|||||||0.048|||||||Log Rank|||||||0.048
70904404|NCT02608489|141297541|SUPERIORITY_OR_OTHER|||||||0.221|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||0.221
70904405|NCT02608489|141297541|SUPERIORITY_OR_OTHER|||||||0.015|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 12 follow-up.||||0.015
70904406|NCT02608489|141297542|SUPERIORITY_OR_OTHER|||||||0.256|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||0.256
70904407|NCT02608489|141297542|SUPERIORITY_OR_OTHER|||||||0.025|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at Postoperative week 12 follow-up.||||0.025
70904408|NCT02608489|141297543|SUPERIORITY_OR_OTHER|||||||0.08|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||0.080
70904409|NCT02608489|141297543|SUPERIORITY_OR_OTHER|||||||0.021|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 12 follow-up.||||0.021
70904410|NCT02608489|141297544|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||<0.001
70904411|NCT02608489|141297544|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 4||||<0.001
70967318|NCT01431274|141440920|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.051|0.1||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.100|0.051|<0.0001
70967319|NCT01431274|141440920|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.048|STANDARD_ERROR_OF_MEAN|0.013||0.0001|TWO_SIDED|95.0|0.023|0.072||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.072|0.023|0.0001
70967320|NCT01431274|141440920|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.012||0.0014|TWO_SIDED|95.0|0.015|0.064||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.064|0.015|0.0014
70967321|NCT01431274|141440920|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.024|STANDARD_ERROR_OF_MEAN|0.012||0.0554|TWO_SIDED|95.0|-0.001|0.048||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.048|-0.001|0.0554
70967322|NCT01431274|141440920|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.047|0.096||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.096|0.047|<0.0001
70967323|NCT01431274|141440920|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.036|STANDARD_ERROR_OF_MEAN|0.013||0.0041|TWO_SIDED|95.0|0.011|0.06||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.060|0.011|0.0041
70967324|NCT01431274|141440920|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.028|STANDARD_ERROR_OF_MEAN|0.013||0.0248|TWO_SIDED|95.0|0.004|0.053||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.053|0.004|0.0248
70967325|NCT01431274|141440920|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.008|STANDARD_ERROR_OF_MEAN|0.013||0.5338|TWO_SIDED|95.0|-0.017|0.032||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.032|-0.017|0.5338
70967326|NCT01431274|141440921|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.077|STANDARD_ERROR_OF_MEAN|0.024||0.0017|TWO_SIDED|95.0|0.029|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.125|0.029|0.0017
70967327|NCT01431274|141440921|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.138|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.09|0.186||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.186|0.090|<0.0001
70967328|NCT01431274|141440921|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.024||0.0426|TWO_SIDED|95.0|0.002|0.098||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.098|0.002|0.0426
70967329|NCT01431274|141440921|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.122|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.074|0.17||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.170|0.074|<0.0001
70904412|NCT02608489|141297544|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 12||||<0.001
70967330|NCT01431274|141440921|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.111|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.063|0.159||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.159|0.063|<0.0001
70967331|NCT01431274|141440921|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.027|STANDARD_ERROR_OF_MEAN|0.025||0.2661|TWO_SIDED|95.0|-0.021|0.075||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.075|-0.021|0.2661
70967332|NCT01431274|141440921|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.102|0.198||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.198|0.102|<0.0001
70967333|NCT01431274|141440921|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.061|STANDARD_ERROR_OF_MEAN|0.024||0.0119|TWO_SIDED|95.0|-0.109|-0.014||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||-0.014|-0.109|0.0119
70967334|NCT01431274|141440921|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.073|STANDARD_ERROR_OF_MEAN|0.024||0.0029|TWO_SIDED|95.0|-0.121|-0.025||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||-0.025|-0.121|0.0029
70967335|NCT01431274|141440921|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.011|STANDARD_ERROR_OF_MEAN|0.024||0.6408|TWO_SIDED|95.0|-0.036|0.059||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.059|-0.036|0.6408
70967336|NCT01431274|141440922|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.221|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.173|0.27||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.270|0.173|<0.0001
70967337|NCT01431274|141440922|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.193|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.145|0.242||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.242|0.145|<0.0001
70967338|NCT01431274|141440922|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.185|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.136|0.233||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.233|0.136|<0.0001
70967339|NCT01431274|141440922|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.114|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.065|0.162||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.162|0.065|<0.0001
70967340|NCT01431274|141440922|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.157|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.108|0.205||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.205|0.108|<0.0001
70967341|NCT01431274|141440922|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.037|STANDARD_ERROR_OF_MEAN|0.025||0.1355|TWO_SIDED|95.0|-0.012|0.085||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.085|-0.012|0.1355
70967342|NCT01431274|141440922|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.151|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.102|0.199||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.199|0.102|<0.0001
70967343|NCT01431274|141440922|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.028|STANDARD_ERROR_OF_MEAN|0.025||0.2562|TWO_SIDED|95.0|-0.02|0.076||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.076|-0.020|0.2562
70967344|NCT01431274|141440922|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.025||0.0041|TWO_SIDED|95.0|0.022|0.119||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.119|0.022|0.0041
70967345|NCT01431274|141440922|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.043|STANDARD_ERROR_OF_MEAN|0.025||0.0815|TWO_SIDED|95.0|-0.091|0.005||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.005|-0.091|0.0815
70967346|NCT01431274|141440923|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.195|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.149|0.242||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.242|0.149|<0.0001
70967347|NCT01431274|141440923|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.153|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.107|0.199||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.199|0.107|<0.0001
70967348|NCT01431274|141440923|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.174|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.128|0.221||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.221|0.128|<0.0001
70967349|NCT01431274|141440923|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.107|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.061|0.154||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.154|0.061|<0.0001
70967350|NCT01431274|141440923|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.086|0.178||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.178|0.086|<0.0001
70967351|NCT01431274|141440923|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.024||0.3727|TWO_SIDED|95.0|-0.025|0.067||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.067|-0.025|0.3727
70967352|NCT01431274|141440923|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.128|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.082|0.175||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.175|0.082|<0.0001
70967353|NCT01431274|141440923|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.042|STANDARD_ERROR_OF_MEAN|0.024||0.0744|TWO_SIDED|95.0|-0.004|0.089||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.089|-0.004|0.0744
70967354|NCT01431274|141440923|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.067|STANDARD_ERROR_OF_MEAN|0.024||0.0047|TWO_SIDED|95.0|0.021|0.114||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.114|0.021|0.0047
70967355|NCT01431274|141440923|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.025|STANDARD_ERROR_OF_MEAN|0.024||0.2945|TWO_SIDED|95.0|-0.071|0.022||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.022|-0.071|0.2945
70967356|NCT01431274|141440924|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.205|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.155|0.255||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.255|0.155|<0.0001
70967357|NCT01431274|141440924|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.156|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.107|0.206||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.206|0.107|<0.0001
70967358|NCT01431274|141440924|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.192|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.142|0.242||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.242|0.142|<0.0001
70967359|NCT01431274|141440924|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.124|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.074|0.174||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.174|0.074|<0.0001
70967360|NCT01431274|141440924|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.144|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.094|0.193||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.193|0.094|<0.0001
70967361|NCT01431274|141440924|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.013|STANDARD_ERROR_OF_MEAN|0.025||0.6103|TWO_SIDED|95.0|-0.037|0.062||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.062|-0.037|0.6103
70967362|NCT01431274|141440924|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.137|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.087|0.186||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.186|0.087|<0.0001
70967363|NCT01431274|141440924|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.049|STANDARD_ERROR_OF_MEAN|0.025||0.0559|TWO_SIDED|95.0|-0.001|0.098||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.098|-0.001|0.0559
70967364|NCT01431274|141440924|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.068|STANDARD_ERROR_OF_MEAN|0.025||0.0073|TWO_SIDED|95.0|0.018|0.118||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.118|0.018|0.0073
70967365|NCT01431274|141440924|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.02|STANDARD_DEVIATION|0.025||0.4368|TWO_SIDED|95.0|-0.07|0.03||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.030|-0.070|0.4368
70967366|NCT01431274|141440925|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.147|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.098|0.196||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.196|0.098|<0.0001
70967367|NCT01431274|141440925|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.025||0.0023|TWO_SIDED|95.0|0.027|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.125|0.027|0.0023
70967368|NCT01431274|141440925|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.121|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.072|0.17||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.170|0.072|<0.0001
70904413|NCT02608489|141297545|SUPERIORITY_OR_OTHER|||||||0.045|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||0.045
70904414|NCT02608489|141297546|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||0.001
70904415|NCT02608489|141297546|SUPERIORITY_OR_OTHER|||||||0.002|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 4||||0.002
70904416|NCT02608489|141297546|SUPERIORITY_OR_OTHER|||||||0.034|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 12||||0.034
70904417|NCT02608489|141297547|SUPERIORITY_OR_OTHER|||||||0.151|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||0.151
70904418|NCT02254408|141297560|SUPERIORITY||Treatment Difference|-0.33||||0.04|TWO_SIDED|95.0|-0.64|-0.02|||ANCOVA|||||-0.02|-0.64|0.040
70904419|NCT02254408|141297561|SUPERIORITY||Odds Ratio (OR)|0.5||||0.11|TWO_SIDED|95.0|0.22|1.18|||Cochran-Mantel-Haenszel|||||1.18|0.22|0.11
70904420|NCT02254408|141297561|SUPERIORITY|||||||0.15|||||||Fisher Exact|||||||0.15
70904421|NCT02254408|141297562|SUPERIORITY||Odds Ratio (OR)|1.01||||0.98|TWO_SIDED|95.0|0.28|3.63|||Cochran-Mantel-Haenszel|||||3.63|0.28|0.98
70904422|NCT02254408|141297562|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
70904423|NCT02914184|141297569|OTHER|The two-sided 95% CIs for the ratio of anti RV IgA antibody GMCs should be within the \[0.5; 2\] clinical limit interval.|GMC Ratio at At Month 2-4|1.07|||||TWO_SIDED|95.0|0.79|1.44|||ANOVA|||GMC Ratio of Anti-RV IgA antibody for Liq\_A and Liq\_B groups was calculated using ANOVA model with vaccine groups and country as fixed effects.||1.44|0.79|
70904424|NCT02914184|141297569|OTHER|The two-sided 95% CIs for the ratio of anti RV IgA antibody GMCs should be within the \[0.5; 2\] clinical limit interval.|GMC Ratio at At Month 2-4|0.88|||||TWO_SIDED|95.0|0.65|1.19|||ANOVA|||GMC Ratio of Anti-RV IgA antibody for Liq\_A and Liq\_C groups was calculated using ANOVA model with vaccine groups and country as fixed effects.||1.19|0.65|
70904425|NCT02914184|141297569|OTHER|The two-sided 95% CIs for the ratio of anti RV IgA antibody GMCs should be within the \[0.5; 2\] clinical limit interval.|GMC Ratio at At Month 2-4|0.82|||||TWO_SIDED|95.0|0.61|1.11|||ANOVA|||GMC Ratio of Anti-RV IgA antibody for Liq\_B and Liq\_C groups was calculated using ANOVA model with vaccine groups and country as fixed effects.||1.11|0.61|
70904426|NCT02914184|141297570|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in SCR for antibodies to rota virus at month 2-4 between the Liq\_Pool group and Lyo Control group should be ≥ -10%.|SCR difference at Month 2-4|-2.49|||||TWO_SIDED|95.0|-7.15|2.63||||||Non-inferiority of Liq\_Pool group compared to Lyo Control group in terms of difference in % of subjects with anti-RV IgA titer ≥ specified cut off with its 2-sided 95% CI in initially seronegative subjects||2.63|-7.15|
70904427|NCT02914184|141297572|NON_INFERIORITY|LL of the two-sided 95% CI for the ratio of anti-RV IgA antibody GMCs between the Liq\_Pool Group and Control group should be ≥ 0.67.|GMC Ratio at At Month 2-4|1.04|||||TWO_SIDED|95.0|0.82|1.33|||ANOVA|||Non-inferiority of Liq\_Pool Group as compared to Lyo Control group in terms of the GMC ratio calculated using ANOVA model with vaccine groups and country as fixed effects||1.33|0.82|
70904428|NCT00798174|141297579|SUPERIORITY|The null hypothesis was that the azygos coil does not reduce the DFT. (A reduced DFT is superiority).||||||0.103||||||Threshold for significance is 0.05.|t-test, 2 sided|Paired t-test||"The null hypothesis is that there is no difference between the DFT using the azygos coil vs. the standard configuration.~Paired t-test (two-tailed), used due to construction of study with DFT determined in both configurations in each patient, yields p=0.103"||||0.103
70904429|NCT01460160|141297588|SUPERIORITY||Estimate of Difference|16.86||||0.032|TWO_SIDED|90.0|3.9|29.8||Superiority test versus AIEOP-BFM 2000|Chi-squared||Treatment difference (CA180372 - AIEOP-BFM 2000)|Difference in 3-year binomial EFS rate in all treated participants (dasatinib plus chemotherapy) vs. chemotherapy alone in AIEOP-BFM 2000 historical control||29.8|3.9|0.032
70904430|NCT01460160|141297588|NON_INFERIORITY|non-inferiority margin = 5%. One-sided type I error rate of 0.05|Estimate of difference|6.91||||0.271|TWO_SIDED|90.0|-3.3|17.2||Superiority test versus EsPhALL|Chi-squared||Treatment difference (CA180372 - EsPhALL) Test if lower confidence limit is above -5%|Difference in 3-year binomial EFS rate for all treated participants (dasatinib plus chemotherapy) vs. continuous imatinib plus chemotherapy in the Amended EsPhALL Trial Historical Control||17.2|-3.3|0.271
70904431|NCT01460160|141297588|SUPERIORITY|Difference in 3-year binomial EFS rate in all treated participants (dasatinib plus chemotherapy) vs. chemotherapy alone in COG AALL0031 historical control|Estimate of difference|-10.75||||0.157|TWO_SIDED|90.0|-22.7|1.2|||Chi-squared||Treatment difference (CA180372 - COG AALL0031)|||1.2|-22.7|0.157
70904432|NCT02387216|141297604|SUPERIORITY||Hazard Ratio (HR)|1.382||||0.2302|TWO_SIDED|95.0|0.813|2.35|||Log Rank|||||2.350|0.813|0.2302
70904433|NCT02387216|141297605|SUPERIORITY||Hazard Ratio (HR)|1.195||||0.5436|TWO_SIDED|95.0|0.673|2.122|||Log Rank|||||2.122|0.673|0.5436
70904434|NCT02387216|141297606|SUPERIORITY||Odds Ratio (OR)|4.3||||0.0455|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0455
70904435|NCT02387216|141297607|SUPERIORITY|||||||0.2726|||||||Log Rank|||||||0.2726
70904436|NCT02563522|141297640|OTHER||Mean Difference (Final Values)|18.7||||0.3455|TWO_SIDED|95.0|-12.37|45.81|||Fisher Exact|No imputation was performed for subjects with missing response data||The statistical hypotheses were H0: Pt = Pc versus Ha: Pt ≠ Pc, where Pt and Pc are the proportions of subjects with a confirmed target would closure by the 4-month follow-up for Active (Engensis) and Control (Placebo) groups, respectively. The hypothesis testing was a two-sided alpha of 0.05||45.81|-12.37|0.3455
70904437|NCT00936221|141297647|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.3873|TWO_SIDED|80.0|0.67|1.28||1-sided p-value|Regression, Cox|Cox model adjusting for treatment, WHO performance status, LDH, M status and tumour sub-type.||If the true hazard ratio (HR) is 0.57, 58 deaths provides at least 80% power to demonstrate a statistically significant difference for OS, assuming a 1-sided 10% significance level.||1.28|0.67|0.3873
70967369|NCT01431274|141440925|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.048|STANDARD_ERROR_OF_MEAN|0.025||0.0545|TWO_SIDED|95.0|-0.001|0.097||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 μg).~Spatial power covariance structure for within-patient errors."|||0.097|-0.001|0.0545
70967370|NCT01431274|141440925|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.025||0.0456|TWO_SIDED|95.0|0.001|0.099||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.099|0.001|0.0456
70967371|NCT01431274|141440925|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.026|STANDARD_ERROR_OF_MEAN|0.025||0.2949|TWO_SIDED|95.0|-0.023|0.075||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.075|-0.023|0.2949
70967372|NCT01431274|141440925|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.074|STANDARD_ERROR_OF_MEAN|0.025||0.0029|TWO_SIDED|95.0|0.025|0.123||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.123|0.025|0.0029
70967373|NCT01431274|141440925|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.025||0.0045|TWO_SIDED|95.0|0.022|0.12||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.120|0.022|0.0045
70967374|NCT01431274|141440925|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.073|STANDARD_ERROR_OF_MEAN|0.025||0.0035|TWO_SIDED|95.0|0.024|0.122||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.122|0.024|0.0035
70967375|NCT01431274|141440925|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.002|STANDARD_ERROR_OF_MEAN|0.025||0.9369|TWO_SIDED|95.0|-0.051|0.047||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.047|-0.051|0.9369
70967376|NCT01431274|141440926|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.168|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.119|0.217||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.217|0.119|<0.0001
70967377|NCT01431274|141440926|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.105|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.056|0.154||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.154|0.056|<0.0001
70967378|NCT01431274|141440926|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.103|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.054|0.152||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.152|0.054|<0.0001
70967379|NCT01431274|141440926|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.025||0.0585|TWO_SIDED|95.0|-0.002|0.096||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.096|-0.002|0.0585
70904438|NCT03820323|141297651|SUPERIORITY||Risk Ratio (RR)|0.99||||0.55|TWO_SIDED|95.0|0.94|1.03|||Modified Poisson regression|||||1.03|0.94|0.55
70904439|NCT03820323|141297652|SUPERIORITY||Risk Ratio (RR)|0.86||||0.28|TWO_SIDED|95.0|0.66|1.13|||Modified Poission regression|||||1.13|0.66|0.28
70904440|NCT00879996|141297676|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9134||||0.77|TWO_SIDED|95.0|0.4156|2.007|||Log Rank|||Null hypothesis: Methadone and buprenorphine treatment do not differ in treatment retention.||2.007|0.4156|0.77
70904441|NCT00879996|141297677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||<|0.043||95.0|||||ANOVA|||Null hypothesis: Methadone treatment is as effective as buprenorphine treatment in reducing pain.||||<0.043
70967380|NCT01431274|141440926|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.041|STANDARD_ERROR_OF_MEAN|0.025||0.1042|TWO_SIDED|95.0|-0.008|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.090|-0.008|0.1042
70967381|NCT01431274|141440926|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.025||0.0097|TWO_SIDED|95.0|0.016|0.114||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.114|0.016|0.0097
70967382|NCT01431274|141440926|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.112|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.063|0.161||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.161|0.063|<0.0001
70967383|NCT01431274|141440926|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.025||0.012|TWO_SIDED|95.0|0.014|0.112||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.112|0.014|0.0120
70967384|NCT01431274|141440926|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.056|STANDARD_ERROR_OF_MEAN|0.025||0.025|TWO_SIDED|95.0|0.007|0.105||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.105|0.007|0.0250
70967385|NCT01431274|141440926|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.007|STANDARD_ERROR_OF_MEAN|0.025||0.7889|TWO_SIDED|95.0|-0.042|0.056||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.056|-0.042|0.7889
70967386|NCT01431274|141440927|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.187|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.138|0.237||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.237|0.138|<0.0001
70967387|NCT01431274|141440927|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.121|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.072|0.17||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.170|0.072|<0.0001
70967388|NCT01431274|141440927|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.153|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.103|0.202||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.202|0.103|<0.0001
70967389|NCT01431274|141440927|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.062|STANDARD_ERROR_OF_MEAN|0.025||0.0134|TWO_SIDED|95.0|0.013|0.111||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.111|0.013|0.0134
70904442|NCT00879996|141297678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|0.0|<|0.665|TWO_SIDED|95.0|||||ANOVA|||null-hypothesis: methadone and buprenorphine treatment are equally effective in reducing self-reported functioning at 6 months.||||<0.665
70904443|NCT00879996|141297679|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|STANDARD_DEVIATION|0.0|<|0.039|TWO_SIDED|95.0|||||Fisher Exact|||Null hypothesis: methadone or buprenorphine treatment equally reduce illicit drug use.||||<0.039
70967390|NCT01431274|141440927|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.086|STANDARD_ERROR_OF_MEAN|0.025||0.0006|TWO_SIDED|95.0|0.037|0.136||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.136|0.037|0.0006
70967391|NCT01431274|141440927|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.035|STANDARD_ERROR_OF_MEAN|0.025||0.167|TWO_SIDED|95.0|-0.015|0.084||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.084|-0.015|0.1670
70967392|NCT01431274|141440927|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.097|STANDARD_ERROR_OF_MEAN|0.025||0.0001|TWO_SIDED|95.0|0.048|0.146||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.146|0.048|0.0001
70967393|NCT01431274|141440927|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.066|STANDARD_ERROR_OF_MEAN|0.025||0.0085|TWO_SIDED|95.0|0.017|0.115||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.115|0.017|0.0085
70967394|NCT01431274|141440927|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.025||0.0003|TWO_SIDED|95.0|0.041|0.14||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.140|0.041|0.0003
70967395|NCT01431274|141440927|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.024|STANDARD_ERROR_OF_MEAN|0.025||0.3332|TWO_SIDED|95.0|-0.074|0.025||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.025|-0.074|0.3332
70967396|NCT01431274|141440928|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.153|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.105|0.201||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.201|0.105|<0.0001
70967397|NCT01431274|141440928|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.077|STANDARD_ERROR_OF_MEAN|0.024||0.0016|TWO_SIDED|95.0|0.029|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.125|0.029|0.0016
70967398|NCT01431274|141440928|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.084|0.18||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.180|0.084|<0.0001
70967399|NCT01431274|141440928|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.041|STANDARD_ERROR_OF_MEAN|0.024||0.0926|TWO_SIDED|95.0|-0.007|0.089||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.089|-0.007|0.0926
70967400|NCT01431274|141440928|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.055|STANDARD_ERROR_OF_MEAN|0.024||0.0231|TWO_SIDED|95.0|0.008|0.103||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.103|0.008|0.0231
70967401|NCT01431274|141440928|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.024||0.3802|TWO_SIDED|95.0|-0.026|0.069||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.069|-0.026|0.3802
70967402|NCT01431274|141440928|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.062|STANDARD_ERROR_OF_MEAN|0.024||0.0105|TWO_SIDED|95.0|0.015|0.11||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.110|0.015|0.0105
70967403|NCT01431274|141440928|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.025||0.0018|TWO_SIDED|95.0|0.028|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.125|0.028|0.0018
70967404|NCT01431274|141440928|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.091|STANDARD_ERROR_OF_MEAN|0.025||0.0002|TWO_SIDED|95.0|0.043|0.139||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.139|0.043|0.0002
70904444|NCT02597933|141297680|OTHER||Mean Difference (Final Values)|40.95|STANDARD_ERROR_OF_MEAN|19.38||0.035|TWO_SIDED|95.0|2.88|79.01|||random coefficient regression||The model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.|The primary analysis is a restricted maximum likelihood (REML) based approach using a random slope \& intercept model. The analysis included the fixed, categorical effects of treatment, ATA status \& gender, fixed continuous effects of time \& baseline FVC (mL), age and height as well as the treatment-by time \& baseline-by-time interactions. Random effects was included for patient response for both time \& intercept.Within-patient errors are modelled by an unstructured variance-covariance matrix||79.01|2.88|0.0350
70904445|NCT02597933|141297680|OTHER||Mean Difference (Final Values)|43.13||||0.0378|TWO_SIDED|95.0|2.44|83.83|||random coefficient regression|The model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.||"This is a sensitivity analysis (SA) on primary endpoint including only on-trt measurements of FVC \[mL\]. The random coefficient model was used. The analysis included fixed, categorical effects of trt, ATA status \& gender, fixed continuous effects of time \& bl. FVC (mL), age, height, trt -by time \& bl.-by-time interactions. Random effects included for patient response for both time \& intercept.~Within-patient errors were modelled by an Unstructured variance-covariance matrix."||83.83|2.44|0.0378
70904446|NCT02597933|141297680|OTHER||Mean Difference (Final Values)|30.0||||0.1046|TWO_SIDED|95.0|-6.22|66.22|||random coefficient regression|||In multiple imputation SA 1, missing FVC values at wk 52 in pts who were alive at wk 52 were imputed assuming similar rate of FVC decline as in pts from corresponding trt group who prematurely disc. trial drug but had wk 52 FVC value. Missing FVC values at wk 52 in pts who died before wk 52 were imputed assuming similar rate of FVC decline as in pl. pts with wk 52 FVC value who prematurely disc. trial drug with most severe declines.The imputation model was similar to statistical model of PA.||66.22|-6.22|0.1046
70904447|NCT02597933|141297680|OTHER||Mean Difference (Final Values)|32.93||||0.074|TWO_SIDED|95.0|-3.19|69.06|||random coefficient regression|||In multiple imputation SA 2, missing FVC values at wk 52 in pts who were alive at wk 52 were imputed assuming similar rate of FVC decline as in pts from pl. group who prematurely disc. trial drug but had a wk 52 FVC value. Missing FVC values at wk 52 in pts who died before wk 52 were imputed assuming similar rate of FVC decline as in pl. pts with a wk 52 FVC value who prematurely disc. trial drug with most severe declines. The imputation model was similar to the statistical model of the PA||69.06|-3.19|0.0740
70904448|NCT02597933|141297680|OTHER||Mean Difference (Final Values)|33.86||||0.0644|TWO_SIDED|95.0|-2.03|69.75|||random coefficient regression|||In multiple imputation SA 3, missing FVC values at wk 52 in pts who were alive at wk 52 were imputed assuming a similar rate of FVC decline as in all pts in the pl. group who were included in the PA. Missing FVC values at wk 52 in pts who died before wk 52 were imputed assuming a similar rate of FVC decline as in all placebo patients included in the primary analysis with the most severe declines. The imputation model was similar to the statistical model of the PA.||69.75|-2.03|0.0644
70904449|NCT02597933|141297680|OTHER||Mean Difference (Final Values)|40.95||||0.0351|TWO_SIDED|95.0|2.88|79.01|||random coefficient regression|||This is sensitivity analysis using the model similar to the primary analysis but including a different set of covariates: the fixed, categorical effects of treatment, ATA status, the fixed continuous effects of time, baseline FVC (mL), and the treatment-by-time and baseline-by-time interactions.Random effects was included for patient response for both time and intercept.||79.01|2.88|0.0351
70904450|NCT02597933|141297680|OTHER||Mean Difference (Final Values)|40.98||||0.0349|TWO_SIDED|95.0|2.92|79.04|||random coefficient regression|||This is sensitivity analysis using the model similar to the primary analysis but including a different set of covariates: the fixed, categorical effects of treatment, ATA status (Positive / Negative), gender and mycophenolate mofetil /sodium background therapy use (Yes / No), fixed continuous effects of time, age , height and baseline FVC (mL), the treatment-by-time and baseline-by-time interactions. Random effects was included for patient response for both time and intercept||79.04|2.92|0.0349
70904451|NCT02597933|141297681|OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.37||0.5785|TWO_SIDED|95.0|-0.94|0.53|||MMRM|||The mixed model repeated measures (MMRM) approach was used. The model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.||0.53|-0.94|0.5785
70904452|NCT02597933|141297682|OTHER||Mean Difference (Final Values)|1.69|STANDARD_ERROR_OF_MEAN|1.24||0.1711|TWO_SIDED|95.0|-0.73|4.12|||MMRM|The MMRM model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||4.12|-0.73|0.1711
70904453|NCT02597933|141297683|OTHER||Mean Difference (Final Values)|1.15|STANDARD_ERROR_OF_MEAN|0.54||0.0331|TWO_SIDED|1.15|0.09|2.21|||MMRM|The model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.||"Based on a random coefficient regression with fixed categorical effects of treatment, ATA status, fixed continuous effects of time, baseline FVC \[% pred\], \& including treatment-by-time and baseline-by-time interactions. Random effect was included for patient specific intercept \& time.~Within-patient errors are modelled by an Unstructured variance-covariance matrix.~Inter-individual variability is modelled by a Variance-Components variance-covariance matrix."||2.21|0.09|0.0331
70904454|NCT02597933|141297684|OTHER||Mean Difference (Final Values)|46.41|STANDARD_ERROR_OF_MEAN|19.51||0.0177|TWO_SIDED|95.0|8.09|84.73|||MMRM|The model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||84.73|8.09|0.0177
70967405|NCT01431274|141440928|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.014|STANDARD_ERROR_OF_MEAN|0.024||0.5554|TWO_SIDED|95.0|-0.062|0.034||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.034|-0.062|0.5554
70904455|NCT02597933|141297685|OTHER||Mean Difference (Final Values)|-6.28|STANDARD_ERROR_OF_MEAN|8.39||0.4547|TWO_SIDED|95.0|-22.77|10.21|||MMRM|The model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||10.21|-22.77|0.4547
70904456|NCT02597933|141297686|OTHER||Hazard Ratio (HR)|1.16||||0.7535|TWO_SIDED|95.0|0.47|2.84|||Regression, Cox|Based on Cox's regression model (Wald test), stratified by ATA status.||||2.84|0.47|0.7535
70904457|NCT02597933|141297687|OTHER||Odds Ratio (OR)|1.03||||0.9115|TWO_SIDED|95.0|0.57|1.88|||Cochran-Mantel-Haenszel|||The comparison between both treatment groups was performed using a Cochran-Mantel-Haenszel test. CRISS score at Week 52 was transformed into 100 binary responder endpoints using multiple imputation. These were analyzed using a Cochran-Mantel-Haenszel test, stratified by ATA status OR and the 95% confidence interval (CI) as obtained from all 100 imputations were combined using Rubin´s rule.|Missing values were imputed using worst case, i.e. considered having disease progression.|1.88|0.57|0.9115
70904458|NCT02597933|141297688|OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.76||0.5668|TWO_SIDED|95.0|-1.94|1.06|||MMRM|||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||1.06|-1.94|0.5668
70904459|NCT02597933|141297689|OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.5914|TWO_SIDED|95.0|-0.16|0.09|||MMRM|||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||0.09|-0.16|0.5914
70904460|NCT02597933|141297690|OTHER||Mean Difference (Final Values)|0.032|STANDARD_ERROR_OF_MEAN|0.034||0.3447|TWO_SIDED|95.0|-0.035|0.099|||MMRM|||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||0.099|-0.035|0.3447
70904461|NCT02597933|141297691|OTHER||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.58||0.2727|TWO_SIDED|95.0|-0.51|1.79|||MMRM|||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||1.79|-0.51|0.2727
70904462|NCT01097915|141297698|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Fisher Exact|||||||<0.01
70904463|NCT01097915|141297699|SUPERIORITY_OR_OTHER||||||<|0.004|||||||ANOVA|||||||<0.004
70904464|NCT01097915|141297700|SUPERIORITY_OR_OTHER||||||<|0.048|||||||ANCOVA|the three factors of the Stunkard and Messick Questionnaire were considered as covariates.||||||<0.048
70904465|NCT01097915|141297701|SUPERIORITY_OR_OTHER||||||<|1e-05|||||||ANOVA|||||||< 0.00001
70904466|NCT01097915|141297702|SUPERIORITY_OR_OTHER||||||<|1e-05|||||||ANOVA|||||||< 0.00001
70904467|NCT01097915|141297703|SUPERIORITY_OR_OTHER||||||<|1e-05|||||||Chi-squared|||||||< 0.00001
70904468|NCT01107743|141297709|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.812|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between male and female in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.812
70904469|NCT01107743|141297710|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=1.000
70904470|NCT01107743|141297711|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hypertension. The null hypothesis is there is no difference between with Hypetension and without Hypertension in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=1.000
70904471|NCT01107743|141297712|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.112|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hypertension severity. The null hypothesis is there is no difference among ClassⅠHypertension, ClassⅡ Hypertension, and ClassⅢ Hypertension in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.112
70904472|NCT01107743|141297713|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.093|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Angina Pectoris. The null hypothesis is there is no difference between with Angina Pectoris and without Angina Pectoris in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.093
70904473|NCT01107743|141297714|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hypercholesterolemia. The null hypothesis is there is no difference between with Hypercholesterolemia and without Hypercholesterolemia in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=1.000
70904474|NCT01107743|141297715|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.839|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hypercholesterolemia expression type. The null hypothesis is there is no difference among expression type Ⅰ, expression type Ⅱa, expression type Ⅱb, expression type Ⅲ, expression type, expression type Ⅳ, and expression type Ⅴ in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.839
70904475|NCT01107743|141297716|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Familial Hypercholesterolemia. The null hypothesis is there is no difference between with Familial Hypercholesterolemia and without Familial Hypercholesterolemia in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=1.000
70904476|NCT01107743|141297717|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with Hepatic Dysfunction and without Hepatic Dysfunction in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=1.000
70904477|NCT01107743|141297718|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.644|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with Renal Dysfunction and without Renal Dysfunction in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.644
70904478|NCT01107743|141297719|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.155|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Complications. The null hypothesis is there is no difference between with Complications and without Complications in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.155
70904479|NCT01107743|141297720|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.305|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Concomitant Drugs. The null hypothesis is there is no difference between with Concomitant Drugs and without Concomitant Drugs in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.305
70904480|NCT01107743|141297721|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.234|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the participants of responders."||||=0.234
70904481|NCT01107743|141297722|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.439|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years in the participants of responders."||||=0.439
70904482|NCT01107743|141297723|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.761|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hypertension severity. The null hypothesis is there is no difference among ClassⅠHypertension, ClassⅡ Hypertension, and ClassⅢ Hypertension in the participants of responders."||||=0.761
70904483|NCT01107743|141297724|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with and without Hepatic Dysfunction in the participants of responders."||||=1.000
70904484|NCT01107743|141297725|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.31|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without Renal Dysfunction in the participants of responders."||||=0.310
70904485|NCT01107743|141297726|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.251|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Complications. The null hypothesis is there is no difference between with and without Complications in the participants of responders."||||=0.251
70904486|NCT01107743|141297727|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.756|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Concomitant Drugs. The null hypothesis is there is no difference between with and without Concomitant Drugs in the participants of responders."||||=0.756
70904487|NCT01107743|141297728|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.706|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the participants of responders."||||=0.706
70904488|NCT01107743|141297729|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.192|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years in the participants of responders."||||=0.192
70904489|NCT01107743|141297730|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.005|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Angina Pectoris Severity. The null hypothesis is there is no difference among Class1, Class2, Class3, and Class4 in the participants of responders."||||=0.005
70904490|NCT01107743|141297731|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with and without Hepatic Dysfunction in the participants of responders."||||=1.000
70904491|NCT01107743|141297732|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.596|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without Renal Dysfunction in the participants of responders."||||=0.596
70904492|NCT01107743|141297733|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.252|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Complications. The null hypothesis is there is no difference between with and without Complications in the participants of responders."||||=0.252
70904493|NCT01107743|141297734|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Concomitant Drugs. The null hypothesis is there is no difference between with and without Concomitant Drugs in the participants of responders."||||=1.000
70904494|NCT01107743|141297735|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.518|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the participants of responders."||||=0.518
70904495|NCT01107743|141297736|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.645|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years in the participants of responders."||||=0.645
70904496|NCT01107743|141297737|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.13|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hypercholesterolemia expression type. The null hypothesis is there is no difference among expression type Ⅰ, expression type Ⅱa, expression type Ⅱb, expression type Ⅲ, expression type, expression type Ⅳ, and expression type Ⅴ in the participants of responders."||||=0.130
70904497|NCT01107743|141297738|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.185|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with and without Hepatic Dysfunction in the participants of responders."||||=0.185
70904498|NCT01107743|141297739|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.714|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without Renal Dysfunction in the participants of responders."||||=0.714
70904499|NCT01107743|141297740|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.835|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Complications. The null hypothesis is there is no difference between with and without Complications in the participants of responders."||||=0.835
70904500|NCT01107743|141297741|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.252|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Concomitant Drugs. The null hypothesis is there is no difference between with and without Concomitant Drugs in the participants of responders."||||=0.252
70904501|NCT00308737|141297742|NON_INFERIORITY_OR_EQUIVALENCE|Comparison of TI + Usual Care to Usual Care only|Mean Difference (Final Values)|0.037|||||TWO_SIDED|95.0|0.014|0.06|||Mixed Models Analysis|Repeated measures||Mixed model repeated measures with fixed effects diabetes type, visit, pooled site and treatment and baseline FEV1 as a covariate||0.060|0.014|
70904502|NCT00308737|141297743|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis tested was that the FEV1 change from Baseline for the TI group is no greater than 50 mL/year above the change in the usual care treatment group. Assuming SD of 100 mL/y, 80% power, and 5% (1-tailed) significance level, it was determined that 50 subjects were required for each of the diabetes treatment groups. Final sample size was selected for the incidence of a \>= 15% decrease in FEV1 end point.|Mean Difference (Final Values)|0.037|||||TWO_SIDED|95.0|0.016|0.057|||ANCOVA|||ANCOVA model with treatment site, diabetes type, and baseline FEV1||0.057|0.016|
70904503|NCT00308737|141297744|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.034|||||TWO_SIDED|95.0|0.008|0.061|||Mixed Models Analysis|Repeated measures||Mixed model repeated measures with fixed effects diabetes type, visit, pooled site and treatment and baseline FVC as a covariate||0.061|0.008|
70904504|NCT00308737|141297745|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.005|||||TWO_SIDED|95.0|-0.042|0.031|||Mixed Models Analysis|Repeated measures||Mixed model repeated measures with fixed effects diabetes type, visit, pooled site, and treatment and baseline TLC as a covariate||0.031|-0.042|
70904505|NCT00308737|141297746|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.269|||||TWO_SIDED|95.0|-0.037|0.574|||Mixed Models Analysis|Repeated measures||Mixed model repeated measures with fixed effects diabetes type, visit, pooled site, and treatment and baseline TLC as a covariate||0.574|-0.037|
70904506|NCT00308737|141297747|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6475|||||TWO_SIDED|95.0|0.3432|1.2219|||Regression, Logistic|||Logistic regression excluding non-diabetics||1.2219|0.3432|
70904507|NCT00308737|141297748|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7504|||||TWO_SIDED|95.0|0.251|2.2431|||Regression, Logistic|||Logistic regression excluding non-diabetics||2.2431|0.2510|
70904508|NCT00308737|141297749|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8953|||||TWO_SIDED|95.0|0.6703|1.1958|||Regression, Logistic|||Logistic regression excluding non-diabetics||1.1958|0.6703|
70904509|NCT00308737|141297750|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.8509|||||TWO_SIDED|95.0|0.6722|1.077|||Regression, Logistic|||Logistic regression excluding non-diabetics||1.0770|0.6722|
70904510|NCT00308737|141297752|SUPERIORITY_OR_OTHER|||||||0.112||95.0|||||t-test, 2 sided|||Two sample t-test||||0.112
70904511|NCT00308737|141297753|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis tested was that the difference in incidence of a decrease of ≥ 15% in FEV1 between the treatment groups not be greater than 5% for TI when compared with the usual care treatment group. Assuming an incidence rate of 15% for FEV1 and a noninferiority criterion of a 5% difference in incidence between the treatment groups, approximately 625 subjects per group were required for 80% power and an alpha of 5% (1 tailed).|Odds Ratio (OR)|-2.4767|||||TWO_SIDED|95.0|-4.5578|-0.3956|||Regression, Logistic|||Logistic regression excluding non-diabetics||-0.3956|-4.5578|
70904512|NCT02224482|141297754|SUPERIORITY|||||||0.9634|||||||Mixed Models Analysis|||||||.9634
70904513|NCT02224482|141297755|SUPERIORITY|||||||0.5214|||||||Mixed Models Analysis|||||||.5214
70904514|NCT02224482|141297756|SUPERIORITY|||||||0.4875|||||||Mixed Models Analysis|||||||.4875
70904515|NCT02224482|141297757|SUPERIORITY|||||||0.7938|||||||Mixed Models Analysis|||||||.7938
70904516|NCT02224482|141297758|SUPERIORITY|||||||0.6765|||||||Mixed Models Analysis|||||||.6765
70904517|NCT02224482|141297759|SUPERIORITY|||||||0.7061|||||||Mixed Models Analysis|||||||.7061
70904518|NCT02224482|141297760|SUPERIORITY|||||||0.7593|||||||Mixed Models Analysis|||||||.7593
70904519|NCT04078035|141297761|SUPERIORITY||Slope|-0.00015|STANDARD_ERROR_OF_MEAN|0.00088||0.86|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.86
70904520|NCT04078035|141297762|SUPERIORITY||Slope|0.00022|STANDARD_ERROR_OF_MEAN|0.00067||0.74|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results present the condition (stress/control) by time interactions.||||0.74
70904521|NCT04078035|141297763|SUPERIORITY||Slope|-0.0012|STANDARD_ERROR_OF_MEAN|0.0019||0.52|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.52
70904522|NCT04078035|141297764|SUPERIORITY|Results present the condition (stress/control) by time\^2 interactions.|Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED||||||Mixed Models Analysis|Likelihood ratio test showed better fit if quadratic for time included χ2 (2) = 77.2, p \< .001.||||||<.001
70904523|NCT04078035|141297765|SUPERIORITY||Slope|0.0021|STANDARD_ERROR_OF_MEAN|0.00027|<|0.001|TWO_SIDED||||||Mixed Models Analysis|Likelihood ratio test showed better fit if quadratic for time included χ2 (2) = 66.4, p \< .001.||Results-interaction between time2 and condition||||<.001
70904524|NCT04078035|141297766|SUPERIORITY||Slope|0.0013|STANDARD_ERROR_OF_MEAN|0.0002|<|0.001|TWO_SIDED||||||Mixed Models Analysis|Likelihood ratio test showed better fit if quadratic for time included χ2 (2) = 77.2, p \< .001.||Results-interaction between time\^2 and condition||||<.001
70904525|NCT04078035|141297767|SUPERIORITY||Slope|0.0037|STANDARD_ERROR_OF_MEAN|0.0013||0.005|TWO_SIDED||||||Mixed Models Analysis|||Results below present the condition (stress/control) by time interactions.||||0.005
70904526|NCT04078035|141297768|SUPERIORITY||Slope|-0.0071|STANDARD_ERROR_OF_MEAN|0.074||0.92|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.92
70904527|NCT04078035|141297769|SUPERIORITY||Slope|-0.85|STANDARD_ERROR_OF_MEAN|0.41||0.04|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.04
70904528|NCT04078035|141297770|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.0033||0.002|TWO_SIDED|||||Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.|Mixed Models Analysis|Likelihood ratio test showed better fit if quadratic for time included χ2 (2) = 15.64, p \< .001.||Results-interaction between time\^2 and condition||||0.002
70904529|NCT04078035|141297771|SUPERIORITY||Slope|0.014|STANDARD_ERROR_OF_MEAN|0.0053||0.008|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results \_condition (stress/control) by time interactions.||||0.008
70904530|NCT04078035|141297772|SUPERIORITY||Slope|-0.0003|STANDARD_ERROR_OF_MEAN|0.0014||0.83|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.83
70904531|NCT04078035|141297773|SUPERIORITY||Slope|-0.0074|STANDARD_ERROR_OF_MEAN|0.0033||0.03|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.03
70904532|NCT04078035|141297774|SUPERIORITY||Slope|0.00075|STANDARD_ERROR_OF_MEAN|0.00012||0.51|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.51
70904533|NCT04078035|141297775|SUPERIORITY||Slope|-0.0053|STANDARD_ERROR_OF_MEAN|0.0026||0.04|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.04
70904534|NCT04078035|141297776|SUPERIORITY||Slope|0.0018|STANDARD_ERROR_OF_MEAN|0.0027||0.49|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.49
70904535|NCT04078035|141297777|SUPERIORITY||Slope|0.013|STANDARD_ERROR_OF_MEAN|0.0044||0.002|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.002
70904536|NCT01396395|141297891|SUPERIORITY_OR_OTHER||Ratio|0.503|||<|0.0001|TWO_SIDED|95.0|0.435|0.581|||poisson regression: Non-calibration mode|||||0.581|0.435|<0.0001
70904537|NCT01396395|141297891|SUPERIORITY_OR_OTHER||Ratio|0.503|||=|0.0086|TWO_SIDED|95.0|0.301|0.84|||Poisson regression: Calibration model|||||0.840|0.301|=0.0086
70904538|NCT04524598|141297924|SUPERIORITY||t|-1.911||||0.06|TWO_SIDED||||||Mixed Models Analysis|||A linear mixed-effects model (LMM) analysis was implemented on an averaged imputed dataset to evaluate main effects of Group (Spark, Control) and Week (0-5), and the Group x Week interaction. Group and Week were entered as fixed factors. Spark version, and assessment completion days since baseline were included as fixed factors to control for effects of app version and differences in time between completion of successive weekly assessments.||||0.06
70904539|NCT04524598|141297924|SUPERIORITY||t|-2.546||||0.01|TWO_SIDED||||||Mixed Models Analysis|||We used a Per Protocol approach that included participants who completed the PHQ at baseline and each week. A linear mixed-effects model (LMM) analysis was implemented on an averaged imputed dataset to evaluate main effects of Group (Spark, Control) and Week (0-5), and the Group x Week interaction.||||0.01
70904540|NCT04524598|141297927|SUPERIORITY||F|1.46||||0.23|TWO_SIDED||||||ANOVA|||We conducted a repeated measures ANOVA (Group x Time) on GAD-7 scores to compare the change in anxiety symptoms from Baseline to Post treatment for Phase II participants who had a baseline PHQ-8 score \>= 10. The interaction term is presented.||||0.23
70904541|NCT04524598|141297927|SUPERIORITY||F|2.59||||0.11|TWO_SIDED||||||ANOVA|||We conducted a repeated measures ANOVA (Group x Time) on the PROMIS - General Health Score to compare the change in general health from Baseline to Post treatment for Phase II participants who had a baseline PHQ-8 score \>= 10. The interaction term is reported.||||0.11
70904542|NCT04524598|141297928|SUPERIORITY||F|0.94||||0.33|TWO_SIDED||||||ANOVA|||We conducted a repeated measures ANOVA (Time x Group) on the MFQ to compare the change in parent report of depressive symptoms from Baseline to Post treatment for Phase II participants who had a baseline PHQ-8 score \>= 10. The interaction term is presented.||||0.33
70904543|NCT04524598|141297928|SUPERIORITY||F|0.02||||0.9|TWO_SIDED||||||ANOVA|||We conducted a repeated measures ANOVA (Group x Time) on the PROMIS Parent Proxy - General Health Score to compare the change in parent reported general health from Baseline to Post treatment for Phase II participants who had a baseline PHQ-8 score \>= 10. The interaction term is reported.||||0.90
70904544|NCT00550550|141297984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63|||=|0.001|TWO_SIDED|95.0|-2.6|-0.66|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||-0.66|-2.60|=0.001
70904545|NCT00550550|141297985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|||=|0.005|TWO_SIDED|95.0|-1.95|-0.45|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||-0.45|-1.95|=0.005
70904546|NCT00550550|141297986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||=|0.066|TWO_SIDED|95.0|-0.88|0.03|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||0.03|-0.88|=0.066
70904547|NCT00550550|141297987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|||=|0.042|TWO_SIDED|95.0|-0.6|-0.03|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||-0.03|-0.60|=0.042
70904548|NCT02090634|141298004|SUPERIORITY|||||||0.95||||||Cliff's d = 0.01; calculated to estimate the effect size for between-group comparisons with non-parametric data|Wilcoxon (Mann-Whitney)|||We conducted Wilcoxon rank sum (Mann-Whitney) tests in order to examine group (i.e., iTAB vs. CTRL) differences on overall adherence to ARV medications.||||0.95
70904549|NCT02090634|141298004|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|Cliff's d = -0.13; calculated to estimate the effect size for between-group comparisons with non-parametric data||We conducted Wilcoxon rank sum (Mann-Whitney) tests in order to examine group (i.e., iTAB vs. CTRL) differences on overall adherence to PSY medications.||||0.43
70904550|NCT02090634|141298005|SUPERIORITY|||||||0.02||||||Cliff's d = 0.37; calculated to estimate the effect size for between-group comparisons with non-parametric data|Wilcoxon (Mann-Whitney)|||We conducted Wilcoxon rank sum (Mann-Whitney) tests in order to examine group (i.e., iTAB vs. CTRL) differences on overall dose timing windows for ARV medications.||||0.02
70904551|NCT02090634|141298005|SUPERIORITY|||||||0.42||||||Cliff's d = 0.14; calculated to estimate the effect size for between-group comparisons with non-parametric data|Wilcoxon (Mann-Whitney)|||We conducted Wilcoxon rank sum (Mann-Whitney) tests in order to examine group (i.e., iTAB vs. CTRL) differences on overall dose timing windows for PSY medications.||||0.42
70904552|NCT00697190|141298009|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|97.5|-0.29|0.04|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senoflicon A toric is non-inferior to galyfilcon A toric in conjunctival hyperemia.||0.04|-0.29|
70904553|NCT00697190|141298010|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|97.5|-0.1|0.06|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival hyperemia.||0.06|-0.10|
70904554|NCT00697190|141298011|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|97.5|-0.23|0.1|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival hyperemia.||0.10|-0.23|
70904555|NCT00697190|141298012|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|97.5|-0.25|0.04|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in limbal hyperemia.||0.04|-0.25|
70904556|NCT00697190|141298013|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|97.5|-0.16|0.07|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in limbal hyperemia.||0.07|-0.16|
70904557|NCT00697190|141298014|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|97.5|-0.25|0.14|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in limbal hyperemia.||0.14|-0.25|
70904558|NCT00697190|141298015|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|97.5|0.04|0.32|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in corneal staining.||0.32|0.04|
70904559|NCT00697190|141298016|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|97.5|-0.26|0.08|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in corneal staining.||0.08|-0.26|
70904560|NCT00697190|141298017|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Median Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.08||||97.5|0.02|0.33|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in corneal staining.||0.33|0.02|
70904561|NCT00697190|141298018|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|97.5|-0.27|0.26|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival staining.||0.26|-0.27|
70904562|NCT00697190|141298019|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|97.5|-0.34|-0.08|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival staining.||-0.08|-0.34|
70904563|NCT00697190|141298020|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|97.5|-0.54|-0.15|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival staining.||-0.15|-0.54|
70904564|NCT00697190|141298021|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|97.5|-0.12|0.14|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in papillary conjunctivitis.||0.14|-0.12|
70904565|NCT00697190|141298022|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|97.5|-0.23|0.05|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in papillary conjunctivitis.||0.05|-0.23|
70904566|NCT00697190|141298023|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|97.5|-0.2|0.02|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in papillary conjunctivitis.||0.02|-0.20|
70904567|NCT01411501|141298062|SUPERIORITY_OR_OTHER|||||||0.352|TWO_SIDED||||||ANCOVA|||||||0.352
70904568|NCT01411501|141298063|SUPERIORITY_OR_OTHER|||||||0.968|TWO_SIDED||||||ANCOVA|||||||0.968
70904569|NCT01411501|141298064|SUPERIORITY_OR_OTHER|||||||0.841|TWO_SIDED||||||Kruskal-Wallis|||||||0.841
70904570|NCT01411501|141298065|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||ANCOVA|||||||0.005
70904571|NCT01411501|141298066|SUPERIORITY_OR_OTHER|||||||0.198|TWO_SIDED||||||ANCOVA|||||||0.198
70904572|NCT01411501|141298067|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||Kruskal-Wallis|||||||0.035
70904573|NCT04105972|141298068|SUPERIORITY||Least Squares (LS) Mean Difference|15.9|||<|0.0001|TWO_SIDED|95.0|11.7|20.1|||Mixed-effects Model for Repeated Measure|||||20.1|11.7|< 0.0001
70904574|NCT04105972|141298069|SUPERIORITY||LS Mean Difference|10.2|||<|0.0001|TWO_SIDED|95.0|8.2|12.1|||Mixed-effects Model for Repeated Measure|||||12.1|8.2|<0.0001
70904575|NCT04105972|141298070|SUPERIORITY||LS Mean Difference|-42.8|||||TWO_SIDED|95.0|-46.2|-39.3||||||||-39.3|-46.2|
70904576|NCT01161472|141298073|SUPERIORITY_OR_OTHER||Least square (LS) Mean Difference|-0.0285|STANDARD_ERROR_OF_MEAN|0.018||0.1198|TWO_SIDED|95.0|-0.0647|0.0077|||ANCOVA|||Analysis of Covariance (ANCOVA) was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||0.0077|-0.0647|0.1198
70904577|NCT01161472|141298073|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0203|STANDARD_ERROR_OF_MEAN|0.0173||0.2459|TWO_SIDED|95.0|-0.0551|0.0145|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||0.0145|-0.0551|0.2459
70904578|NCT01161472|141298075|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0037|STANDARD_ERROR_OF_MEAN|0.0115||0.7502|TWO_SIDED|95.0|-0.0268|0.0194|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||0.0194|-0.0268|0.7502
70904579|NCT01161472|141298075|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0085|STANDARD_ERROR_OF_MEAN|0.0119||0.4785|TWO_SIDED|95.0|-0.0325|0.0154|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||0.0154|-0.0325|0.4785
70904580|NCT01161472|141298077|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0035|STANDARD_ERROR_OF_MEAN|0.0265||0.8944|TWO_SIDED|95.0|-0.0569|0.0498|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||0.0498|-0.0569|0.8944
70904581|NCT01161472|141298077|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0209|STANDARD_ERROR_OF_MEAN|0.0263||0.4308|TWO_SIDED|95.0|-0.032|0.0738|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||0.0738|-0.0320|0.4308
70904582|NCT01161472|141298079|SUPERIORITY_OR_OTHER||LS Mean Difference|3.6629|STANDARD_ERROR_OF_MEAN|12.4945||0.7707|TWO_SIDED|95.0|-21.4729|28.7987|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||28.7987|-21.4729|0.7707
70904583|NCT01161472|141298079|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.921|STANDARD_ERROR_OF_MEAN|12.4482||0.1162|TWO_SIDED|95.0|-44.9634|5.1215|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||5.1215|-44.9634|0.1162
70904584|NCT01161472|141298081|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0068|STANDARD_ERROR_OF_MEAN|4.8707||0.9989|TWO_SIDED|95.0|-9.8297|9.8433|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||9.8433|-9.8297|0.9989
70904585|NCT01161472|141298081|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6251|STANDARD_ERROR_OF_MEAN|5.0346||0.7485|TWO_SIDED|95.0|-11.7926|8.5425|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||8.5425|-11.7926|0.7485
70904586|NCT01161472|141298083|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2684|STANDARD_ERROR_OF_MEAN|0.8243||0.7458|TWO_SIDED|95.0|-1.3788|1.9157|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||1.9157|-1.3788|0.7458
70904587|NCT01161472|141298083|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0661|STANDARD_ERROR_OF_MEAN|0.8277||0.9366|TWO_SIDED|95.0|-1.7202|1.588|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||1.5880|-1.7202|0.9366
70904588|NCT01118455|141298109|SUPERIORITY_OR_OTHER|||||||0.507|||||||Cochran-Mantel-Haenszel|||||||0.507
70904589|NCT01118455|141298109|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Cochran-Mantel-Haenszel|||||||0.220
70904590|NCT01118455|141298109|SUPERIORITY_OR_OTHER|||||||0.168||95.0|||||Cochran-Mantel-Haenszel|||||||0.168
70904591|NCT01118455|141298109|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Cochran-Mantel-Haenszel|||||||0.620
70904592|NCT01118455|141298110|SUPERIORITY_OR_OTHER|||||||0.727|||||||Wilcoxon (Mann-Whitney)|||||||0.727
70904593|NCT01118455|141298110|SUPERIORITY_OR_OTHER|||||||0.217|||||||Wilcoxon (Mann-Whitney)|||||||0.217
70904594|NCT01118455|141298110|SUPERIORITY_OR_OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.270
70904595|NCT01118455|141298110|SUPERIORITY_OR_OTHER|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||||||0.036
70904596|NCT01118455|141298111|SUPERIORITY_OR_OTHER|||||||0.448||95.0|||||t-test, 2 sided|||||||0.448
70904597|NCT01118455|141298111|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||t-test, 2 sided|||||||0.025
70904598|NCT01118455|141298111|SUPERIORITY_OR_OTHER|||||||0.799|||||||t-test, 2 sided|||||||0.799
70904599|NCT01118455|141298111|SUPERIORITY_OR_OTHER|||||||0.142|||||||t-test, 2 sided|||||||0.142
70904600|NCT01118455|141298112|SUPERIORITY_OR_OTHER|||||||0.714||95.0|||||t-test, 2 sided|||||||0.714
70904601|NCT01118455|141298112|SUPERIORITY_OR_OTHER|||||||0.426||95.0|||||t-test, 2 sided|||||||0.426
70904602|NCT01118455|141298112|SUPERIORITY_OR_OTHER|||||||0.467|||||||t-test, 2 sided|||||||0.467
70904603|NCT01118455|141298112|SUPERIORITY_OR_OTHER|||||||0.654|||||||t-test, 2 sided|||||||0.654
70904604|NCT01118455|141298113|SUPERIORITY_OR_OTHER|||||||0.691|||||||ANOVA|||||||0.691
70904605|NCT01118455|141298113|SUPERIORITY_OR_OTHER|||||||0.494|||||||ANOVA|||||||0.494
70904606|NCT01118455|141298113|SUPERIORITY_OR_OTHER|||||||0.343|||||||ANOVA|||||||0.343
70904607|NCT01118455|141298113|SUPERIORITY_OR_OTHER|||||||0.295|||||||ANOVA|||||||0.295
70904608|NCT03810313|141298147|NON_INFERIORITY|Non-inferiority was considered to be established if the lower limit of the corresponding 95% CI for the estimated between group difference (brolucizumab vs. aflibercept) on change from baseline in BCVA at Week 24 is \> -4 letters.|Least Square Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|1.2||0.173|TWO_SIDED|95.0|-5.2|-0.5|||ANOVA|||||-0.5|-5.2|0.173
70904609|NCT00136812|141298163|OTHER|We used all available observations in a GEE analysis and did not impute missing data or drop observations.|Odds Ratio (OR)|3.15||||0.018|TWO_SIDED|95.0|1.22|8.14||P-value of \<0.05 is considered statistically significant.|generalized estimating equation model|||To test the primary hypothesis, we ran a generalized estimating equation model with logit link function (PROC GENMOD in SAS version 9.2), to examine abstinence versus smoking status at the 3- through 18-month follow-ups by condition.||8.14|1.22|0.018
70904610|NCT04542226|141298168|OTHER||||||<|1e-07||||||the a priori threshold for statistical significance p\<0.05|Wilcoxon (Mann-Whitney)|Wilcoxon signed-rank test for repeated measures was used to compare with baseline.||||||<0.0000001
70904611|NCT03029780|141298177|SUPERIORITY||DIFFERENCE IN INCIDENCE RATES|0.0|||||TWO_SIDED|95.0|-12.3|12.3||||||||12.3|-12.3|
70904612|NCT03029780|141298177|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.3|3.39|||Cochran-Mantel-Haenszel|||||3.39|0.30|
70904613|NCT03029780|141298178|SUPERIORITY||DIFFERENCE IN INCIDENCE RATES|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.00|0.00|
70904614|NCT03029780|141298179|SUPERIORITY||DIFFERENCE IN INCIDENCE RATES|5.8|||||TWO_SIDED|95.0|-13.3|24.8||||||||24.8|-13.3|
70904615|NCT03029780|141298179|SUPERIORITY||Odds Ratio (OR)|1.27|||||TWO_SIDED|95.0|0.58|2.78|||Cochran-Mantel-Haenszel|||||2.78|0.58|
70904616|NCT03029780|141298180|SUPERIORITY||DIFFERENCE IN INCIDENCE RATES|7.7|||||TWO_SIDED|95.0|-10.1|25.5||||||||25.5|-10.1|
70904617|NCT03029780|141298180|SUPERIORITY||Odds Ratio (OR)|1.42|||||TWO_SIDED|95.0|0.62|3.24|||Cochran-Mantel-Haenszel|||||3.24|0.62|
70904618|NCT03560258|141298185|SUPERIORITY|||||||0.137|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm B: Full-length Gag DNA in additional number of CEs with a CD4 or CD8 T cell response from week 0 to week 26.||||0.137
70904619|NCT03560258|141298185|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm C: Placebo in additional number of CEs with a CD4 or CD8 T cell response from week 0 to week 26.||||0.014
70904620|NCT03560258|141298185|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: Full-length Gag DNA and Arm C: Placebo in additional number of CEs with a CD4 or CD8 T cell response from week 0 to week 26.||||0.100
70904621|NCT03560258|141298187|SUPERIORITY|||||||0.222|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm B: Full-length Gag DNA in additional number of CEs with a CD4 T cell response at week 26 from baseline.||||0.222
70904622|NCT03560258|141298187|SUPERIORITY|||||||0.222|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm C: Placebo in additional number of CEs with a CD4 T cell response at week 26 from baseline.||||0.222
70904623|NCT03560258|141298187|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: Full-length Gag DNA and Arm C: Placebo in additional number of CEs with a CD4 T cell response at week 26 from baseline.||||1.00
70904624|NCT03560258|141298188|SUPERIORITY|||||||0.678|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm B: Full-length Gag DNA in additional number of CEs with a CD8 T cell response from week 0 to week 26.||||0.678
70904625|NCT03560258|141298188|SUPERIORITY|||||||0.037|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm C: Placebo in additional number of CEs with a CD8 T cell response from week 0 to week 26.||||0.037
70904626|NCT03560258|141298188|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: Full-length Gag DNA and Arm C: Placebo in additional number of CEs with a CD8 T cell response from week 0 to week 26.||||0.100
70904627|NCT03560258|141298189|SUPERIORITY|||||||0.303|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm B: Full-length Gag DNA in change in the magnitude of CD4 T cell responses from week 0 to week 26.||||0.303
70904628|NCT03560258|141298189|SUPERIORITY|||||||0.457|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm C: Placebo in change in the magnitude of CD4 T cell responses from week 0 to week 26.||||0.457
70904629|NCT03560258|141298189|SUPERIORITY|||||||0.678|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: Full-length Gag DNA and Arm C: Placebo in change in the magnitude of CD4 T cell responses from week 0 to week 26.||||0.678
70904630|NCT03560258|141298190|SUPERIORITY|||||||0.755|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm B: Full-length Gag DNA in change in the magnitude of CD8 T cell responses from week 0 to week 26.||||0.755
70904631|NCT03560258|141298190|SUPERIORITY|||||||0.867|||||||Wilcoxon (Mann-Whitney)|||||||0.867
70904632|NCT03560258|141298190|SUPERIORITY|||||||0.521|||||||Wilcoxon (Mann-Whitney)|||||||0.521
70904633|NCT01027364|141298258|SUPERIORITY_OR_OTHER_LEGACY||Bleeding Rate Ratio|0.17|||<|0.001|TWO_SIDED|95.0|0.11|0.24||A hierarchical approach was applied to the comparison of the annualized bleeding rates between the prophylaxis arms and the episodic arm.|negative binomial model|||The null hypothesis for the primary endpoint is no difference between any prevention regimen and the on-demand regimen. The sample size of this study was mainly based on clinical rather than statistical considerations. However it was projected to have \> 95% power at the 2-sided 0.05 level of significance, based upon this hypothesis test.||0.24|0.11|<0.001
70904634|NCT01027364|141298258|SUPERIORITY_OR_OTHER_LEGACY||Bleeding Rate Ratio|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.2||A hierarchical approach was applied to the comparison of the annualized bleeding rates between the prophylaxis arms and the episodic arm.|negative binomial model|||The null hypothesis for the primary endpoint is no difference between any prevention regimen and the on-demand regimen. The sample size of this study was mainly based on clinical rather than statistical considerations.||0.20|0.08|<0.001
70904635|NCT01003184|141298269|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.6|||<|0.0001|TWO_SIDED|95.0|3.17|13.73|||Regression, Logistic|Logistic regression model includes treatment group, use of SU (yes/no), baseline HbA1c and baseline weight as main factors.||"Primary objective: to test hypothesis that the percentage of patients with HbA1c ≤7.0% with weight loss (≥1.0 kg) after exenatide QW is superior to insulin detemir.~Sample size estimation: based on the test for difference in percentage between Exenatide QW and insulin detemir. Assuming: common drop-out rate 20%, response rate at endpoint 50% in the exenatide QW group and 25% in the insulin detemir group; 5% significance. 214 patients will provide 90% power to detect a difference."||13.73|3.17|<.0001
70904636|NCT01003184|141298270|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.06|||<|0.0001|TWO_SIDED|95.0|3.64|13.7|||Regression, Logistic|Logistic regression model includes the independent variables treatment group, use of SU (yes/no), baseline HbA1c and baseline weight.||||13.70|3.64|<.0001
70904637|NCT01003184|141298271|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.104||0.0001|TWO_SIDED|95.0|-0.62|-0.2|||Mixed Models Analysis|||Mixed model repeated measures (MMRM) includes baseline value as covariate, study treatment, use of SU (yes/no), week of visit and treatment-by-week interaction as fixed effects and patient and error as random effects.||-0.20|-0.62|0.0001
70904638|NCT01003184|141298272|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.67|STANDARD_ERROR_OF_MEAN|0.488|<|0.0001|TWO_SIDED|95.0|-4.63|-2.71|||Mixed Models Analysis|||Mixed model repeated measures MMRM) includes baseline value as covariate, study treatment, use of SU (yes/no), baseline HbA1c stratum, week of visit and treatment-by-week interaction as fixed effects and patient and error as random effects.||-2.71|-4.63|<.0001
70904639|NCT01003184|141298273|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.79||||0.0497|TWO_SIDED|95.0|1.0|3.18|||Regression, Logistic|||Logistic regression model includes independent variables treatment group, use of SU (yes/no), and baseline HbA1c.||3.18|1.00|0.0497
70904640|NCT01003184|141298274|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21||||0.0074|TWO_SIDED|95.0|1.24|3.96|||Regression, Logistic|||Logistic regression model includes independent variables treatment group, use of SU (yes/no), and baseline HbA1c.||3.96|1.24|0.0074
70904641|NCT01003184|141298275|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.89||||0.0002|TWO_SIDED|95.0|2.1|11.35|||Regression, Logistic|||Logistic regression model includes independent variables treatment group, use of SU (yes/no), and baseline HbA1c.||11.35|2.10|0.0002
70904642|NCT01003184|141298276|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.257||0.6993|TWO_SIDED|95.0|-0.41|0.61|||ANCOVA|||ANCOVA model includes treatment group, baseline value, use of SU (yes/no) and baseline HbA1c stratum as factors.||0.61|-0.41|0.6993
70904643|NCT01003184|141298277|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.72|STANDARD_ERROR_OF_MEAN|1.853||0.0116|TWO_SIDED|95.0|-8.37|-1.07|||Mixed Models Analysis|||Mixed model repeated measures (MMRM) includes baseline value as covariate, study treatment, use of SU (yes/no), baseline HbA1c stratum, week of visit and treatment-by-week interaction as fixed effects and patient and error as random effects.||-1.07|-8.37|0.0116
70904644|NCT01003184|141298278|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|1.179||0.7034|TWO_SIDED|95.0|-2.77|1.88|||Mixed Models Analysis|||Mixed model repeated measures (MMRM) includes baseline value as covariate, study treatment, use of SU (yes/no), baseline HbA1c stratum, week of visit and treatment-by-week interaction as fixed effects and patient and error as random effects.||1.88|-2.77|0.7034
70904645|NCT01003184|141298279|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.1061|TWO_SIDED|95.0|-0.32|0.03|||ANCOVA|||ANCOVA model includes treatment group, baseline value, use of SU (yes/no) and baseline HbA1c stratum as factors.||0.03|-0.32|0.1061
70904646|NCT01003184|141298280|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.4638|TWO_SIDED|95.0|-0.05|0.02|||ANCOVA|||ANCOVA model includes treatment group, baseline value, use of SU (yes/no) and baseline HbA1c stratum as factors.||0.02|-0.05|0.4638
70904647|NCT01003184|141298281|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.107||0.4967|TWO_SIDED|95.0|-0.14|0.28|||ANCOVA|||ANCOVA model includes treatment group, baseline value, use of SU (yes/no) and baseline HbA1c stratum as factors.||0.28|-0.14|0.4967
70904648|NCT01003184|141298282|SUPERIORITY_OR_OTHER||Ratio|0.58|STANDARD_ERROR_OF_MEAN|0.322||0.3247|TWO_SIDED|95.0|0.19|1.72|||Poisson regression|||The number of episodes by patient were compared between treatment groups using a poisson model with effects for treatment and baseline HbA1c and the logarithm of the days of exposure as the offset variable.||1.72|0.19|0.3247
70904649|NCT03662997|141298284|SUPERIORITY|In this superiority study the primary efficacy analysis included constructing a two sided 5% significance level, using Fisher's non-parametric permutation test for ordered categorical variables and dichotomous variables for the differences. Numbers, percentages improved, not changed, worsened were analyzed with Mantel-Haenszel Exact Chi square over the course of 4 weeks in a 2x2 weeks treatment period inferiority will be established.||||||0.046||||||Five-layer vs Hydrocellular arm, Weeks 1 \& 3|Chi-squared||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||0.046
70904650|NCT03662997|141298284|SUPERIORITY|In this superiority study the primary efficacy analysis included constructing a two sided 5% significance level, using Fisher's non-parametric permutation test for ordered categorical variables and dichotomous variables for the differences. Numbers, percentages improved, not changed, worsened were analyzed with Mantel-Haenszel Exact Chi square over the course of 4 weeks in a 2x2 weeks treatment period inferiority will be established.||||||0.56||||||Five-layer vs Hydrocellular arm; Weeks 2 \& 4|Chi-squared||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||0.56
70904651|NCT03662997|141298284|SUPERIORITY|In this superiority study the primary efficacy analysis included constructing a two sided 5% significance level, using Fisher's non-parametric permutation test for ordered categorical variables and dichotomous variables for the differences. Numbers, percentages improved, not changed, worsened were analyzed with Mantel-Haenszel Exact Chi square over the course of 4 weeks in a 2x2 weeks treatment period inferiority will be established.||||||0.01||||||Five-layer vs Hydropolymer arm; Weeks 1 \& 3|Chi-squared||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||0.010
70904652|NCT03662997|141298284|SUPERIORITY|In this superiority study the primary efficacy analysis included constructing a two sided 5% significance level, using Fisher's non-parametric permutation test for ordered categorical variables and dichotomous variables for the differences. Numbers, percentages improved, not changed, worsened were analyzed with Mantel-Haenszel Exact Chi square over the course of 4 weeks in a 2x2 weeks treatment period inferiority will be established.||||||0.25||||||Five-layer vs Hydropolymer arm; Weeks 2 \& 4|Chi-squared||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||0.25
70904653|NCT03662997|141298285|SUPERIORITY|In this superiority study the primary efficacy analysis included constructing a two sided 5% significance level, using Fisher's non-parametric permutation test for ordered categorical variables and dichotomous variables for the differences. Numbers, percentages improved, not changed, worsened were analyzed with Mantel-Haenszel Exact Chi square over the course of 4 weeks in a 2x2 weeks treatment period inferiority will be established.||||||0.046||||||Five-layer vs Hydrocellular; End of Weeks 1 and 3.|Chi-squared, Corrected||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||0.046
70904654|NCT03662997|141298285|SUPERIORITY|In this superiority study the primary efficacy analysis included constructing a two sided 5% significance level, using Fisher's non-parametric permutation test for ordered categorical variables and dichotomous variables for the differences. Numbers, percentages improved, not changed, worsened were analyzed with Mantel-Haenszel Exact Chi square over the course of 4 weeks in a 2x2 weeks treatment period inferiority will be established.||||||0.01||||||Five-layer vs Hydropolymer; End of Weeks 1 \& 3|Chi-squared, Corrected||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups|||0.010
70904655|NCT03662997|141298293|SUPERIORITY|This secondary outcome measure was not planned for at the initiation of the study. Compliance rates were calculated by combining the number incidences that dressings were worn for the full 7 days and when the dressings do not have strike-through during first the week of treatment.|||||<|0.05||||||Five-layer vs Hydrocellular arm, first week of treatment|Chi-squared||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||<0.05
70904656|NCT03662997|141298293|SUPERIORITY|This secondary outcome measure was not planned for at the initiation of the study. Compliance rates were calculated by combining the number incidences that dressings were worn for the full 7 days and when the dressings do not have strike-through during the first week of treatment.|||||<|0.05||||||Five-layer vs Hydropolymer, first week of treatment.|Chi-squared||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||<0.05
70904657|NCT00406419|141298330|SUPERIORITY||Weighted difference|18.5|||<|0.0001|TWO_SIDED|95.0|11.0|25.9|||Cochran-Mantel-Haenszel|||||25.9|11|< 0.0001
70904658|NCT00406419|141298330|SUPERIORITY||Weighted difference|21.4|||<|0.0001|TWO_SIDED|95.0|14.1|28.8|||Cochran-Mantel-Haenszel|||||28.8|14.1|< 0.0001
70904659|NCT00406419|141298331|SUPERIORITY||Weighted difference|30.8|||<|0.0001|TWO_SIDED|95.0|23.7|37.9|||Cochran-Mantel-Haenszel|||||37.9|23.7|< 0.0001
70904660|NCT00406419|141298331|SUPERIORITY||Weighted difference|34.5|||<|0.0001|TWO_SIDED|95.0|27.4|41.5|||Cochran-Mantel-Haenszel|||||41.5|27.4|< 0.0001
70904661|NCT01535274|141298357|SUPERIORITY||||||<|0.001|||||||ANOVA|||P-values represent comparison of successive set points within anesthetic type (i.e.: Set Point 1 compared to Set Point 2, Set Point 2 compared to Set Point 3, etc.). This P-value was determined for each of set points 1, 2, 3, 4, and 5.||||<0.001
70904662|NCT00882921|141298391|SUPERIORITY_OR_OTHER_LEGACY||Relative Risk|2.873||||0.1309|TWO_SIDED|95.0|0.731|11.296|||Negative Binomial Model|||The groups compared are Ab+ vs Ab-||11.296|0.731|0.1309
70904663|NCT00882921|141298391|SUPERIORITY_OR_OTHER_LEGACY||Relative Risk|2.082||||0.2718|TWO_SIDED|95.0|0.563|7.706|||Negative Binomial Model|||The groups compared are Ab+ (age adjusted) vs Ab- (age adjusted)||7.706|0.563|0.2718
70904664|NCT00856661|141298404|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.229|TWO_SIDED|95.0|0.79|2.64|||Regression, Logistic|If no assessment was available for last observation carried forward after baseline, the mRS score was set to 5 if alive, or 6, if otherwise = death||All patients who were treated and had at least one valid post-baseline assessment of the mRS. As death is a valid outcome on the mRS, patients who died within 90 days after IMP administration were included.||2.64|0.79|0.2290
70904665|NCT00856661|141298405|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9401|TWO_SIDED|95.0|0.59|1.62|||Regression, Logistic|||||1.62|0.59|0.9401
70904666|NCT00856661|141298406|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.5076|TWO_SIDED|95.0|0.68|2.18|||Regression, Logistic|||All patients treated, who had at least one valid post-baseline assessment of the mRS and with a baseline NIHSS score of 8 to 24. If no assessment was available for last observation carried forward after baseline, the mRS score was set to 5 if the patient was known to be alive, or 6, if otherwise = dead.||2.18|0.68|0.5076
70904667|NCT00856661|141298407|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.6146|TWO_SIDED|95.0|0.72|1.75|||Regression, Logistic|||all patients treated, who had at least one valid post-baseline assessment of the mRS. As death is a valid outcome on the mRS, patients who died within 90 days after IMP administration were included||1.75|0.72|0.6146
70904668|NCT02120664|141298409|SUPERIORITY_OR_OTHER||R squared|0.907|||||TWO_SIDED||||||Regression, Linear|||||||
70904669|NCT02120664|141298410|SUPERIORITY_OR_OTHER||Coefficient of Variation|2.53|||||TWO_SIDED|||||||||||||
70904670|NCT02120664|141298410|SUPERIORITY_OR_OTHER||Coefficient of Variation|6.69|||||TWO_SIDED|||||||||||||
70904671|NCT02306122|141298413|SUPERIORITY||Risk Difference (RD)|-0.015|STANDARD_ERROR_OF_MEAN|0.034|<|0.01|TWO_SIDED||||||Regression, Logistic||Comparator is control arm|||||<0.01
70904672|NCT02306122|141298413|SUPERIORITY||Risk Difference (RD)|-0.015|STANDARD_ERROR_OF_MEAN|0.041|<|0.01|TWO_SIDED||||||Regression, Logistic||Comparator is control arm|||||<0.01
70904673|NCT02306122|141298413|SUPERIORITY||Risk Difference (RD)|0.012|STANDARD_ERROR_OF_MEAN|0.029|<|0.01|TWO_SIDED||||||Regression, Logistic||Comparator is control arm|||||<0.01
70904674|NCT02306122|141298414|SUPERIORITY||Mean Difference (Final Values)|-0.128|STANDARD_ERROR_OF_MEAN|2.523|<|0.01|TWO_SIDED||||||Regression, Linear||Comparator is the control arm|||||<0.01
70904675|NCT02306122|141298414|SUPERIORITY||Mean Difference (Final Values)|-1.582|STANDARD_ERROR_OF_MEAN|2.997|<|0.01|TWO_SIDED||||||Regression, Linear||Comparator is the control arm|||||<0.01
70904676|NCT02306122|141298414|SUPERIORITY||Mean Difference (Final Values)|0.308|STANDARD_ERROR_OF_MEAN|2.38|<|0.01|TWO_SIDED||||||Regression, Linear||Comparator is the control arm|||||<0.01
70904677|NCT02306122|141298415|SUPERIORITY||Risk Difference (RD)|-0.043|STANDARD_ERROR_OF_MEAN|0.068|<|0.01|TWO_SIDED||||||Regression, Logistic||Comparator is the information arm|||||<0.01
70904678|NCT02306122|141298415|SUPERIORITY||Risk Difference (RD)|0.06|STANDARD_ERROR_OF_MEAN|0.063|<|0.01|TWO_SIDED||||||Regression, Logistic||Comparator is the information arm|||||<0.01
70904679|NCT02306122|141298416|SUPERIORITY||Risk Difference (RD)|0.42|STANDARD_ERROR_OF_MEAN|0.071|<|0.01|TWO_SIDED||||||Regression, Logistic||Comparator is the choice arm|||||<0.01
70904680|NCT01518946|141298477|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|521.0||||0.0131|TWO_SIDED|95.0|124.2|917.7|||ANOVA|||||917.7|124.2|0.0131
70904681|NCT00384059|141298478|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-3.8|3.9||||||For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 titer was calculated||3.9|-3.8|
70904682|NCT00384059|141298478|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.5||||||95.0|-7.1|3.7||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated||3.7|-7.1|
70904683|NCT00384059|141298478|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-4.1||||||95.0|-13.4|5.1||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated||5.1|-13.4|
70904684|NCT00384059|141298478|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-3.2|3.3||||||For Pertussis PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated||3.3|-3.2|
70904685|NCT00384059|141298478|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|1.1||||||95.0|-4.5|7.1||||||For Pertussis PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 17 EU/mL threshold was calculated||7.1|-4.5|
70904686|NCT00384059|141298478|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-3.2|3.2||||||For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated||3.2|-3.2|
70904687|NCT00384059|141298478|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-3.2|3.2||||||For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 7.82 EU/mL threshold was calculated||3.2|-3.2|
70904688|NCT00384059|141298478|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.5||||||95.0|-7.9|4.8||||||For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 20 EU/mL threshold was calculated||4.8|-7.9|
70904689|NCT00384059|141298478|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-3.2|3.2||||||For Pertussis PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated||3.2|-3.2|
70904690|NCT00384059|141298478|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-3.1||||||95.0|-10.0|3.4||||||For Pertussis PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 15 EU/mL threshold was calculated||3.4|-10.0|
70904691|NCT00384059|141298478|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|2.7||||||95.0|-0.5|7.6||||||For Pertussis FIM the difference in percentage between the two groups (13vPnC - 7vPnC) at 2.2 EU/mL threshold was calculated||7.6|-0.5|
70904692|NCT00384059|141298478|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|1.0||||||95.0|-4.1|6.5||||||For Pertussis FIM the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated||6.5|-4.1|
70904693|NCT00384059|141298479|SUPERIORITY_OR_OTHER||Difference|-5.3||||||95.0|-19.7|8.8||||||For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 titer was calculated||8.8|-19.7|
70904694|NCT00384059|141298479|SUPERIORITY_OR_OTHER||Difference|-0.1||||||95.0|-8.0|8.1||||||For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 titer was calculated||8.1|-8.0|
70904695|NCT00384059|141298480|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-3.5|3.8||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated||3.8|-3.5|
70904696|NCT00384059|141298480|SUPERIORITY_OR_OTHER||Difference|-1.0||||||95.0|-5.3|2.8||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated||2.8|-5.3|
70904697|NCT00384059|141298481|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.89||||||95.0|0.68|1.16||||||For Meningococcal C the GMC ratio (13vPnC/7vPnC) was calculated||1.16|0.68|
70904698|NCT00384059|141298482|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.77||||||95.0|0.54|1.08||||||For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated||1.08|0.54|
70904699|NCT00384059|141298483|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.98||||||95.0|0.82|1.16||||||For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated||1.16|0.82|
70904700|NCT00384059|141298483|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.99||||||95.0|0.83|1.17||||||For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated||1.17|0.83|
70904701|NCT00384059|141298483|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.0||||||95.0|0.8|1.26||||||For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated||1.26|0.80|
70904702|NCT00384059|141298483|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.0||||||95.0|0.81|1.23||||||For Pertussis FIM the GMC ratio (13vPnC/7vPnC) was calculated||1.23|0.81|
70904703|NCT00384059|141298484|SUPERIORITY_OR_OTHER||Ratio|1.13||||||95.0|0.83|1.53||||||For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated||1.53|0.83|
70904704|NCT00384059|141298489|SUPERIORITY_OR_OTHER||Ration|0.85||||||95.0|0.48|1.49||||||For Meningococcal C the GMC ratio (13vPnC/7vPnC) was calculated||1.49|0.48|
70904705|NCT02714205|141298490|SUPERIORITY||Model generated Least Square Mean|-0.54||||0.34|TWO_SIDED|95.0|-1.66|0.58|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||0.58|-1.66|0.34
70904706|NCT02714205|141298491|SUPERIORITY||Model generated Least Square Mean|0.51||||0.88|TWO_SIDED|95.0|-6.15|7.18|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix.|Model generated LS Mean Differences|||7.18|-6.15|0.88
70904707|NCT02714205|141298492|SUPERIORITY||Model generated Least Square Mean|-0.2||||0.57|TWO_SIDED|95.0|-0.88|0.48|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||0.48|-0.88|0.57
70904708|NCT02714205|141298493|SUPERIORITY||Model generated Least Square Mean Differ|-0.09||||0.81|TWO_SIDED|95.0|-0.8|0.63|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||0.63|-0.8|0.81
70904709|NCT02714205|141298494|SUPERIORITY||Model generated Least Square Mean Differ|0.43||||0.3|TWO_SIDED|95.0|-0.38|1.23|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||1.23|-0.38|0.3
70904710|NCT02714205|141298495|SUPERIORITY||Model generated Least Square Mean Differ|0.4||||0.68|TWO_SIDED|95.0|-1.52|2.32|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||2.32|-1.52|0.68
70904711|NCT02714205|141298496|SUPERIORITY||Model generated Least Square Mean Differ|-0.83||||0.12|TWO_SIDED|95.0|-1.89|0.23|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||0.23|-1.89|0.12
70904712|NCT02714205|141298497|SUPERIORITY||Model generated Least Square Mean Differ|-1.41||||0.25|TWO_SIDED|95.0|-3.81|0.99|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||0.99|-3.81|0.25
70904713|NCT00381641|141298504|SUPERIORITY|"Null (historical) response rate for iodine refractory subgroup is 10%. Power=90% for 30% alternative.~Null (historical) response rate for metastatic medullary subgroup is 5%. Power=88% for 25% alternative."|||||<|0.1||||||"For iodine refractory subgroup, null hypothesis could be rejected if 6 or more responses were observed.~For metastatic medullary subgroup, null hypothesis could be rejected if 3 or more responses were observed."|Simon, two-stage design|||Note. The objective was not to compare the two arms (subgroups), but to compare each with historical data.||||<0.10
70904714|NCT01598298|141298509|OTHER|Two-sided test at the alpha=0.05 level|Coefficient for treatment term|-0.82||||0.0002|TWO_SIDED|95.0|-1.24|-0.4||Two-sided p-value; alpha=0.05|Mixed Models Analysis|Adjusted for the protocol-specified stratification factors (baseline average pain and prior taxane use)|The estimation parameter is the model-based coefficient for the treatment term, with placebo as the reference level.|The primary analysis will rely on longitudinal measures of BPI at Weeks 2, 6, and 12 for improved power. Assessment windows of +/- 7 days, +/- 14 days, and +/- 14 days will be allowed for the 2, 6, and 12 week timepoints. The analysis will be performed using mixed models, adjusted for the stratification factors.||-0.40|-1.24|0.0002
70904715|NCT01598298|141298510|OTHER|Two-sided test at the alpha=0.05 level|Coefficient for treatment term|-1.06|||<|0.0001|TWO_SIDED|95.0|-1.57|-0.55||Two-sided p-value; alpha=0.05|Mixed Models Analysis|Adjusted for baseline worst pain score and the protocol-specified stratification factors (baseline average pain and prior taxane use).|The estimation parameter is the model-based coefficient for the treatment term, with placebo as the reference level.|The primary analysis will rely on longitudinal measures of BPI at Weeks 2, 6, and 12 for improved power. Assessment windows of +/- 7 days, +/- 14 days, and +/- 14 days will be allowed for the 2, 6, and 12 week timepoints. The analysis will be performed using mixed models, adjusted for baseline worst pain score and the stratification factors.||-0.55|-1.57|<0.0001
70904716|NCT01598298|141298511|OTHER|Two-sided test at the alpha=0.05 level|Coefficient fro treatment term|-0.95|||<|0.0001|TWO_SIDED|95.0|-1.35|-0.55||Two-sided p-value; alpha=0.05|Mixed Models Analysis|Adjusted for baseline pain interference score and the protocol-specified stratification factors (baseline average pain and prior taxane use).|The estimation parameter is the model-based coefficient for the treatment term, with placebo as the reference level.|The primary analysis will rely on longitudinal measures of pain interference scores at Weeks 2, 6, and 12 for improved power. Assessment windows of +/- 7 days, +/- 14 days, and +/- 14 days will be allowed for the 2, 6, and 12 week timepoints. The analysis will be performed using mixed models, adjusted for baseline pain interference score and the stratification factors.||-0.55|-1.35|<0.0001
70904717|NCT00708721|141298529|OTHER||Maximum Tolerated Dose|1.0|||||TWO_SIDED||||||||Based on cytopenias observed at day 10 (Phase 1 trial only), and the Phase II dose was determined to be 1 mg per day for 7 consecutive days given on a 28 day cycle.|||||
70904718|NCT02341287|141298543|SUPERIORITY||Mean Difference (Net)|14.01|STANDARD_DEVIATION|19.4||0.023|TWO_SIDED|95.0|2.29|25.74||Paired t-test of control average sleep latency vs. heated glove average sleep latency as measured by actigraph.|t-test, 2 sided|||||25.74|2.29|.023
70904719|NCT02341287|141298544|SUPERIORITY|Paired t-test of control average sleep latency vs. heated glove average sleep latency as measured by sleep log.|Mean Difference (Net)|13.51|STANDARD_DEVIATION|16.91|<|0.014|TWO_SIDED|95.0|3.29|23.73|||t-test, 2 sided|||||23.73|3.29|<0.014
70904720|NCT02687412|141298545|SUPERIORITY|||||||0.141|||||||t-test, 2 sided|||||||0.141
70904721|NCT02687412|141298546|SUPERIORITY||Mean Difference (Final Values)|-4041.0|STANDARD_ERROR_OF_MEAN|1831.042||0.029|TWO_SIDED|95.0|-7672.301|-411.065|||t-test, 2 sided|||||-411.065|-7672.301|0.029
70904722|NCT02687412|141298547|SUPERIORITY||Mean Difference (Final Values)|20.3739|STANDARD_ERROR_OF_MEAN|6.4198||0.002|TWO_SIDED|95.0|7.6414|33.1065|||t-test, 2 sided|||||33.1065|7.6414|0.002
70904723|NCT02687412|141298548|SUPERIORITY|||||||0.014|||||||Chi-squared|||||||0.014
70904724|NCT02687412|141298549|SUPERIORITY|||||||0.034|||||||Chi-squared|||||||0.034
70904725|NCT02687412|141298550|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
70904726|NCT02687412|141298551|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
70904727|NCT02687412|141298552|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
70904728|NCT02687412|141298553|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
70904729|NCT02687412|141298554|SUPERIORITY||Mean Difference (Final Values)|-0.10046|STANDARD_ERROR_OF_MEAN|0.1915||0.601|TWO_SIDED|95.0|-0.4819|0.2817|||t-test, 2 sided|||||0.2817|-0.4819|0.601
70904730|NCT02687412|141298555|SUPERIORITY||Mean Difference (Final Values)|164.746|STANDARD_ERROR_OF_MEAN|317.79||0.605|TWO_SIDED|95.0|-465.0|794.0|||t-test, 2 sided|||||794|-465|0.605
70904731|NCT01966796|141298569|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|95.0|||||ANOVA|||The incidence of MDR pathogens (6.7%, 25.5%, 36.9% and 44.6% in PSI II, III, IV, and V, respectively, p=0.002) and mortality rate (0, 5.9%, 12.3%, and 23.8%, respectively, p\<0.001) increased with increasing PSI||||0.002
70904732|NCT00474929|141298607|SUPERIORITY_OR_OTHER||Maximum Tolerated Dose (MTD) Level|1.0|||||TWO_SIDED||||||||Dose Level 1 was chosen as the MTD due to PI concerns about adverse events and frequent dose reductions seen on later cycles at dose level 2. For the best interest of the patients, dose level 1 was chosen as the MTD and the dose level for Phase II.|The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients).||||
70904733|NCT03029247|141298613|SUPERIORITY||LS Mean Difference|-0.17||||0.9694|TWO_SIDED|95.0|-8.8|8.47||p-value for the difference between treatment groups were presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) and its corresponding 95% confidence interval (CI) has been presented.|||8.47|-8.80|0.9694
70904734|NCT03029247|141298614|SUPERIORITY||LS Mean Difference|-1.32||||0.7745|TWO_SIDED|95.0|-10.46|7.83||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) of SBP and its corresponding 95% CI has been presented.|||7.83|-10.46|0.7745
70904735|NCT03029247|141298614|SUPERIORITY||LS Mean Difference|-1.95||||0.291|TWO_SIDED|95.0|-5.62|1.71||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) of DBP and its corresponding 95% CI has been presented.|||1.71|-5.62|0.2910
70904736|NCT03029247|141298614|SUPERIORITY||LS Mean Difference|-2.4||||0.4611|TWO_SIDED|95.0|-8.88|4.07||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) of MAP and its corresponding 95% CI has been presented.|||4.07|-8.88|0.4611
70904737|NCT03029247|141298615|SUPERIORITY||LS Mean Difference|-2.95||||0.1648|TWO_SIDED|95.0|-7.14|1.24||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) and its corresponding 95% CI has been presented.|||1.24|-7.14|0.1648
70904738|NCT03029247|141298616|SUPERIORITY||LS Mean Difference|-13.42||||0.9142|TWO_SIDED|95.0|-261.75|234.92||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of SBP and its corresponding 95% CI has been presented.|||234.92|-261.75|0.9142
70904739|NCT03029247|141298616|SUPERIORITY||LS Mean Difference|-71.7||||0.2266|TWO_SIDED|95.0|-189.21|45.8||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of DBP and its corresponding 95% CI has been presented.|||45.80|-189.21|0.2266
70904740|NCT03029247|141298616|SUPERIORITY||LS Mean Difference|-54.24||||0.5246|TWO_SIDED|95.0|-223.99|115.51||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of MAP and its corresponding 95% CI has been presented.|||115.51|-223.99|0.5246
70904741|NCT03029247|141298617|SUPERIORITY||LS Mean Difference|-74.4||||0.1563|TWO_SIDED|95.0|-178.15|29.34||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of HR and its corresponding 95% CI has been presented.|||29.34|-178.15|0.1563
70904742|NCT03029247|141298618|SUPERIORITY||LS Mean Difference|-2.06||||0.3247|TWO_SIDED|95.0|-6.23|2.1||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) of DBP and its corresponding 95% CI has been presented.|||2.10|-6.23|0.3247
70904743|NCT03029247|141298618|SUPERIORITY||LS Mean Difference|-2.51||||0.4235|TWO_SIDED|95.0|-8.76|3.74||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) of MAP and its corresponding 95% CI has been presented.|||3.74|-8.76|0.4235
70904744|NCT03029247|141298619|SUPERIORITY||LS Mean Difference|-0.13||||0.9353|TWO_SIDED|95.0|-3.41|3.14||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) and its corresponding 95% CI has been presented.|||3.14|-3.41|0.9353
70904745|NCT03029247|141298620|SUPERIORITY||LS Mean Difference|-144.97||||0.2573|TWO_SIDED|95.0|-399.71|109.76||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of SBP and its corresponding 95% CI has been presented.|||109.76|-399.71|0.2573
70904746|NCT03029247|141298620|SUPERIORITY||LS Mean Difference|-117.49||||0.045|TWO_SIDED|95.0|-232.26|-2.72||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of DBP and its corresponding 95% CI has been presented.|||-2.72|-232.26|0.0450
70904747|NCT03029247|141298620|SUPERIORITY||LS Mean Difference|-131.94||||0.1341|TWO_SIDED|95.0|-306.24|42.36||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of MAP and its corresponding 95% CI has been presented.|||42.36|-306.24|0.1341
70904748|NCT03029247|141298621|SUPERIORITY||LS Mean Difference|-97.67||||0.1119|TWO_SIDED|95.0|-219.05|23.71||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of HR and its corresponding 95% CI has been presented.|||23.71|-219.05|0.1119
70904749|NCT00584701|141298706|SUPERIORITY_OR_OTHER||Dfiference in exon expression|1.5|||<|0.001||||||"Expression difference \>\|1.5\| with p-value adjusted for multiple comparisons."|ANCOVA|Between-group gene expression profiles compared between high versus low responders, controlling for age, gender and batch.||||||<.001
70904750|NCT02002884|141298734|SUPERIORITY||LS Mean difference|-0.22|||=|0.017|TWO_SIDED|95.0|-0.4|-0.04|||MMRM|||LS-Means are from mixed model with treatment group, pooled site and pre-treatment status included as fixed factors and AS at baseline, Gross Motor Function Classification System-Extended and Revised (GMFCS-E\&R) level at screening included as covariates. For MMRM visit\*treatment is interaction term repeated factor.||-0.04|-0.4|= 0.017
70904751|NCT02002884|141298734|SUPERIORITY||LS-Mean difference|-0.07|||=|0.546|TWO_SIDED|95.0|-0.29|0.15|||MMRM|||LS-Means are from mixed model with treatment group, pooled site and pre-treatment status included as fixed factors and AS at baseline, GMFCS-E\&R level at screening included as covariates. For MMRM visit\*treatment is interaction term repeated factor.||0.15|-0.29|= 0.546
70904752|NCT02002884|141298735|SUPERIORITY||LS-Mean difference|0.09|||=|0.34|TWO_SIDED|95.0|-0.1|0.28|||ANCOVA|||LS-Means are from analysis of covariance (ANCOVA) with treatment group, pooled site and pretreatment status included as fixed factors and maximum AS score of the two possible primary target patterns flexed elbow or flexed wrist baseline, GMFCS-E\&R level at screening included as covariates.||0.28|-0.1|= 0.34
70904753|NCT02002884|141298735|SUPERIORITY||LS-Mean difference|-0.12|||=|0.297|TWO_SIDED|95.0|-0.36|0.11|||ANCOVA|||LS-Means are from ANCOVA with treatment group, pooled site and pre-treatment status included as fixed factors and maximum AS score of the two possible primary target patterns flexed elbow or flexed wrist baseline, GMFCS-E\&R level at screening included as covariates.||0.11|-0.36|= 0.297
70904754|NCT02966002|141298749|OTHER|||||||0.96|||||||t-test, 2 sided|||||||0.96
70904755|NCT02966002|141298750|OTHER|||||||0.67|||||||t-test, 2 sided|||||||0.67
70904756|NCT02966002|141298751|OTHER|||||||0.18|||||||t-test, 2 sided|||||||0.18
70904757|NCT02966002|141298752|OTHER|||||||0.25|||||||t-test, 2 sided|||||||0.25
70904758|NCT03377790|141298775|SUPERIORITY||||||<|0.0001||||||Differences between treatments arms are compared using a chi-square test.|Chi-squared|||||||<0.0001
70904759|NCT03377790|141298776|SUPERIORITY|||||||0.0067|||||||Chi-squared|Differences between treatments arms are compared using a chi-square test.||||||0.0067
70904760|NCT03377790|141298777|SUPERIORITY|||||||0.0152|||||||Chi-squared|Differences between treatments arms are compared using a chi-square test.||||||0.0152
70904761|NCT03377790|141298778|SUPERIORITY|||||||0.0302|||||||Chi-squared|Differences between treatments arms are compared using a chi-square test.||||||0.0302
70904762|NCT03377790|141298779|SUPERIORITY|||||||0.5921|||||||ANCOVA|Differences between Tx arms are compared using an ANCOVA with treatment as the independent factor and baseline CDLQI composite score as the covariate.||||||0.5921
70904763|NCT03377790|141298780|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Differences between treatment arms are compared using an ANCOVA, with treatment as the independent factor and baseline lesion count as the covariate.||||||<0.0001
70904764|NCT03377790|141298781|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Differences between treatment arms are compared using an ANCOVA, with treatment as the independent factor and baseline lesion count as the covariate.||||||<0.0001
70904765|NCT03377790|141298782|SUPERIORITY||||||<|0.0001|||||||Chi-squared|Differences between treatments arms are compared using a chi-square test.||||||<0.0001
70904766|NCT03377790|141298783|SUPERIORITY||||||<|0.0001|||||||Chi-squared|Differences between treatments arms are compared using a chi-square test.||||||<0.0001
70904767|NCT03377790|141298784|SUPERIORITY|||||||0.052|||||||Chi-squared|Differences between treatments arms are compared using a chi-square test.||||||0.0520
70904768|NCT01200030|141298785|OTHER|The effect size of the intervention was adopted from a mate-analysis . The showed an average effect size of 0.59 in improving the motor control of limbs in people with stroke. A sample size for each group was set at 11 . Presuming that there would be a drop-out rate of 10% during the course of study, an extra 1 subject was recruited in each group. the sample size was 36. The statistical significance was set at 5% (alpha \< 0.05) with power equal to 80%|||||<|0.001||||||Post-hoc pairwise comparisons have been conducted. Please refer to subsequent data analyses.|Kruskal-Wallis|||Null hypothesis: No significant differences existed between the percentage of change in Trunk Impairment Scale (TIS) score among the three groups.||||<0.001
70904769|NCT01200030|141298785|OTHER|||||||1||||||The p-value was adjusted for multiple comparisons. A p-value smaller than 0.05 indicated statistical significance.|Wilcoxon (Mann-Whitney)|||Post-Hoc pairwise comparison comparing the effects of electrical stimulation with exercises group and placebo stimulation with exercises group. Null hypothesis: There was no significant difference existed on the changes of the Trunk Impairment Scale score between the two groups.||||1.00
70904770|NCT01200030|141298785|OTHER|||||||0.002||||||The p-value was adjusted for multiple comparisons. A p-value smaller than 0.05 indicated statistical significance.|Wilcoxon (Mann-Whitney)|||"Post-Hoc pairwise comparison comparing the effects of electrical stimulation with exercises group and control group.~Null hypothesis: There was no significant difference existed on the changes of the Trunk Impairment Scale score between the two groups."||||0.002
70904771|NCT01200030|141298785|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||"Post-Hoc pairwise comparison comparing the effects of placebo stimulation with exercises group and control group.~Null hypothesis: There was no significant difference existed on the changes of the Trunk Impairment Scale score between the two groups."||||0.003
70904772|NCT01200030|141298786|OTHER|||||||0.055|||||||Kruskal-Wallis|||Null hypothesis: No significant differences existed between the percentage of change in reaching distance between the three groups.||||0.055
70904773|NCT02632786|141298787|SUPERIORITY||Risk Ratio (RR)|0.82||||0.319|TWO_SIDED|95.0|0.55|1.21|||Cochran-Mantel-Haenszel|||||1.21|0.55|0.3190
70904774|NCT02632786|141298788|SUPERIORITY||Mean Difference (Net)|-0.78||||0.5563|TWO_SIDED|95.0|-3.37|1.81|||Mixed Models Analysis|||||1.81|-3.37|0.5563
70904775|NCT02632786|141298789|SUPERIORITY||Mean Difference (Net)|5.0||||0.8992|TWO_SIDED|95.0|-11.5|23.0|||ANCOVA|||||23.00|-11.50|0.8992
70904776|NCT02632786|141298790|SUPERIORITY||Risk Ratio (RR)|1.54||||0.3529|TWO_SIDED|95.0|0.6|3.94|||Cochran-Mantel-Haenszel|||||3.94|0.60|0.3529
70904777|NCT02632786|141298791|SUPERIORITY||Mean Difference (Net)|-0.6||||0.757|TWO_SIDED|95.0|-4.2|3.0|||Mixed Models Analysis|||||3.0|-4.2|0.7570
70904778|NCT02632786|141298792|SUPERIORITY||Slope|-71.97||||0.0729|TWO_SIDED|95.0|-150.72|6.79|||Mixed Models Analysis|||||6.79|-150.72|0.0729
70904779|NCT02632786|141298793|SUPERIORITY|||||||0.4142|||||||Cochran-Mantel-Haenszel|||||||0.4142
70904780|NCT02265224|141298794|EQUIVALENCE|The statistical analysis took into account treatment, period, sequence and subject (sequence) as sources of variation. Acceptance criterion for bioequivalence was that the 94.12% confidence interval for the ratio between test and reference of the geometric means of the parameters under consideration fell within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies and to the Pocock α spending function.|Geometric means ratio|89.81||||0.0136|TWO_SIDED|94.12|82.82|97.4||p value for treatment effect|ANOVA|||||97.40|82.82|0.0136
70904781|NCT02265224|141298795|EQUIVALENCE|The statistical analysis took into account treatment, period, sequence and subject (sequence) as sources of variation. Acceptance criterion for bioequivalence was that the 94.12% confidence interval for the ratio between test and reference of the geometric means of the parameters under consideration fell within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies and to the Pocock α spending function.|Geometric means ratio|90.79||||0.0047|TWO_SIDED|94.12|85.25|96.69|||ANOVA|p value for treatment effect||||96.69|85.25|0.0047
70904782|NCT02265224|141298796|EQUIVALENCE|The statistical analysis took into account treatment, period, sequence and subject (sequence) as sources of variation. Acceptance criterion for bioequivalence was that the 94.12% confidence interval for the ratio between test and reference of the geometric means of the parameters under consideration fell within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies and to the Pocock α spending function.|Geometric means ratio|91.86||||0.0095|TWO_SIDED|94.12|86.45|97.61||p value for treatment effect|ANOVA|||||97.61|86.45|0.0095
70904783|NCT02265224|141298797|EQUIVALENCE|The statistical analysis took into account treatment, period, sequence and subject (sequence) as sources of variation. Acceptance criterion for bioequivalence was that the 94.12% confidence interval for the ratio between test and reference of the geometric means of the parameters under consideration fell within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies and to the Pocock α spending function.||||||0.505|||||||Friedman test|||||||0.5050
70904784|NCT01454830|141298818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.44||0.2|TWO_SIDED||||||t-test, 2 sided||unit of measurement, hours/night; positive estimation parameter favors TI group; negative estimation parameter favors UC group|Pilot RCT designed to establish effect size and feasibility outcomes; no a priori power calculation; statistical significance with hypotheses testing was not objective of the pilot trial||||0.20
70904785|NCT01454830|141298819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.48||0.9|TWO_SIDED||||||t-test, 2 sided||unit of measurement: hours/night; positive estimation parameter favors TI group; negative estimation parameter favors UC group|Pilot RCT designed to establish effect size and feasibility outcomes; no a priori power calculation; statistical significance with hypotheses testing was not objective of the pilot trial||||0.90
70904786|NCT01454830|141298820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.53||0.89|TWO_SIDED||||||t-test, 2 sided||units of measurement: hours/night; positive estimation parameter favors TI group; negative estimation parameter favors UC group|Pilot RCT designed to establish effect size and feasibility outcomes; no a priori power calculation; statistical significance with hypotheses testing was not objective of the pilot trial||||0.89
70904787|NCT01454830|141298821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|4.09||0.78|TWO_SIDED||||||t-test, 2 sided||units of measurement: % TST; positive estimation parameter favors TI group; negative estimation parameter favors UC group|Exploratory outcome of PAP use defined within the sleep period, TST (total sleep time).||||0.78
70904788|NCT00569803|141298855|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.86|||||TWO_SIDED|90.0|0.68|1.08|||||Ratio of Geometric Means: 50mg SC over 125mg IV|||1.08|0.68|
70904789|NCT00569803|141298855|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.61|||||TWO_SIDED|90.0|0.48|0.77|||||Ratio of Geometric Means: 100mg SC over 125mg IV|||0.77|0.48|
70904790|NCT00569803|141298855|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.78|||||TWO_SIDED|90.0|0.62|0.99|||||Ratio of Geometric Means: 125mg SC over 125mg IV|||0.99|0.62|
70904791|NCT00569803|141298855|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.89|||||TWO_SIDED|90.0|0.71|1.13|||||Ratio of Geometric Means: 150mg SC over 125mg IV|||1.13|0.71|
70904792|NCT00569803|141298855|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.88|||||TWO_SIDED|90.0|0.69|1.11|||||Ratio of Geometric Means: 200mg SC over 125mg IV|||1.11|0.69|
70904793|NCT00569803|141298855|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.73|||||TWO_SIDED|90.0|0.57|0.92|||||Ratio of Geometric Means: 250mg SC over 125mg IV|||0.92|0.57|
70904794|NCT00569803|141298856|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.87|||||TWO_SIDED|90.0|0.69|1.1|||||Ratio of Geometric Means: 50mg SC over 125mg IV|||1.10|0.69|
70904795|NCT00569803|141298856|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.61|||||TWO_SIDED|90.0|0.48|0.77|||||Ratio of Geometric Means: 100mg SC over 125mg IV|||0.77|0.48|
70904796|NCT00569803|141298856|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.79|||||TWO_SIDED|90.0|0.62|1.0|||||Ratio of Geometric Means: 125mg SC over 125mg IV|||1.00|0.62|
70904797|NCT00569803|141298856|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.9|||||TWO_SIDED|90.0|0.71|1.14|||||Ratio of Geometric Means: 150mg SC over 125mg IV|||1.14|0.71|
70904798|NCT00569803|141298856|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.88|||||TWO_SIDED|90.0|0.69|1.12|||||Ratio of Geometric Means: 200mg SC over 125mg IV|||1.12|0.69|
70904799|NCT00569803|141298856|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.73|||||TWO_SIDED|90.0|0.57|0.92|||||Ratio of Geometric Means: 250mg SC over 125mg IV|||0.92|0.57|
70904800|NCT00569803|141298862|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.9|||||TWO_SIDED|90.0|0.75|1.07|||||AUC(0-T) Ratio of Geometric Means: 1 injection site over 2 injection sites|||1.07|0.75|
70904801|NCT00569803|141298862|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.9|||||TWO_SIDED|90.0|0.75|1.07|||||AUC(INF) Ratio of Geometric Means: 1 injection site over 2 injection sites|||1.07|0.75|
70904802|NCT02006420|141298885|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|Unequal variance assumption||This is the p value for the mean skin thickness of the forearm.||||0.005
70904803|NCT02006420|141298885|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|Unequal variance assumption||This is the p value for the mean skin stiffness of the thigh||||0.71
70904804|NCT02006420|141298886|SUPERIORITY|||||||0.002|||||||Pearson correlation|||This is the p-value for the forearm||||0.002
70904805|NCT02006420|141298886|SUPERIORITY|||||||0.007|||||||Pearson correlation|||This is the p-value for the thigh||||0.007
70904806|NCT02006420|141298887|SUPERIORITY|||||||0.002|||||||Pearson correlation|||This is the p value for the forearm.||||0.002
70904807|NCT02006420|141298887|SUPERIORITY|||||||0.007|||||||Pearson correlation|||This is the p value for the thigh||||0.007
70904808|NCT02006420|141298889|SUPERIORITY||||||<|0.0001|||||||Pearson correlation|||This is the p-value for the forearm||||<.0001
70904809|NCT02006420|141298889|SUPERIORITY||||||<|0.0001|||||||Pearson correlation|||This is the p-value for the thigh||||<0.0001
70904810|NCT02006420|141298891|SUPERIORITY|||||||0.01|||||||Pearson correlation|||This is the p-value for the forearm||||0.01
70904811|NCT02006420|141298891|SUPERIORITY|||||||0.1|||||||Pearson correlation|||This is the p-value for the thigh||||0.10
70904812|NCT00791921|141298892|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Regression, Logistic|||For ACR20 responder rate at Week 12, comparison between the CDP870 200 mg group and the placebo group was performed.||||<0.05
70904813|NCT00791921|141298893|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Regression, Logistic|||||||<0.05
70904814|NCT01965158|141298895|SUPERIORITY_OR_OTHER||Difference|13.0|STANDARD_ERROR_OF_MEAN|4.19||0.002|TWO_SIDED|95.0|4.8|21.3||To control the overall type I error rate to be ≤ 0.05 for the primary and secondary efficacy endpoints, a fixed-sequence (hierarchical) testing approach was applied.|Cochran-Mantel-Haenszel|P-value was calculated by Cochran-Mantel-Haenszel test adjusted by the opioid dose strata.||||21.3|4.8|0.0020
70904815|NCT01965158|141298896|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.271|<|0.0001|TWO_SIDED|95.0|0.77|1.83|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||1.83|0.77|<0.0001
70904816|NCT01965158|141298897|SUPERIORITY_OR_OTHER||LS Mean Difference|2.11|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|1.6|2.63|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||2.63|1.60|<0.0001
70904817|NCT01965158|141298898|SUPERIORITY_OR_OTHER||LS Mean Difference|1.01|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|0.54|1.48|||ANCOVA|ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||1.48|0.54|<0.0001
70904818|NCT01965158|141298899|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73|STANDARD_ERROR_OF_MEAN|0.198||0.0003|TWO_SIDED|95.0|0.34|1.12|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||1.12|0.34|0.0003
70904819|NCT00474175|141298900|SUPERIORITY_OR_OTHER||Treatment difference|16.46|||<|0.001|TWO_SIDED|95.0|7.2|25.7||Alternative hypotheses tested in the study was that benzocaine 20% was significantly (p less than or equal to \[=\<\] 0.05) more effective than placebo.|Cochran-Mantel-Haenszel|||P-value was calculated using Cochran-Mantel-Haenszel (CMH) test which was adjusted for site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and its associated confidence interval (C.I.) was calculated based on CMH weighted percentages and the corresponding standard error.||25.7|7.2|<0.001
70904820|NCT00474175|141298900|SUPERIORITY_OR_OTHER||Treatment difference|9.8||||0.038|TWO_SIDED|95.0|0.3|19.3||Alternative hypotheses tested in the study was that benzocaine 10% was significantly (p=\<0.05) more effective than placebo provided that benzocaine 20% was more effective than placebo.|Cochran-Mantel-Haenszel|||P-value was calculated using CMH test which was adjusted for site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and its associated C.I. was calculated based on CMH weighted percentages and the corresponding standard error.||19.3|0.3|0.038
70904821|NCT00474175|141298900|SUPERIORITY_OR_OTHER||Treatment difference|6.72||||0.047|TWO_SIDED|95.0|0.2|13.3|||Cochran-Mantel-Haenszel|Dose response was considered established if the percentage of responders between the 20% and 10% was greater than or equal to 5%.||P-value was calculated using CMH test which was adjusted for site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and its associated C.I. was calculated based on CMH weighted percentages and the corresponding standard error.||13.3|0.2|0.047
70904822|NCT00474175|141298901|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.02|||<|0.001|TWO_SIDED|95.0|1.55|2.64||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. Hazard Ratio (HR) of Benzocaine 20% relative to the Placebo was calculated. C.I. was based on the Wald statistic.||2.64|1.55|<0.001
70904823|NCT00474175|141298901|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.63|||<|0.001|TWO_SIDED|95.0|1.26|2.12||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. HR of Benzocaine 10% relative to the Placebo was calculated. C.I. was based on the Wald statistic.||2.12|1.26|<0.001
70904824|NCT00474175|141298901|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||0.03|TWO_SIDED|95.0|1.02|1.51||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. HR of Benzocaine 20% relative to the Benzocaine 10% was calculated. C.I. was based on the Wald statistic.||1.51|1.02|0.030
70904825|NCT00474175|141298902|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.04|||<|0.001|TWO_SIDED|95.0|1.57|2.66||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. HR of Benzocaine 20% relative to the Placebo was calculated. C.I. was based on the Wald statistic.||2.66|1.57|<0.001
70904826|NCT00474175|141298902|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.73|||<|0.001|TWO_SIDED|95.0|1.34|2.25||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. HR of Benzocaine 10% relative to the Placebo was calculated. C.I. was based on the Wald statistic.||2.25|1.34|<0.001
70904827|NCT00474175|141298902|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.1|TWO_SIDED|95.0|0.97|1.43||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. HR of Benzocaine 20% relative to the Benzocaine 10% was calculated. C.I. was based on the Wald statistic.||1.43|0.97|0.100
70904828|NCT00474175|141298904|SUPERIORITY_OR_OTHER||Treatment difference|0.49||||0.035|TWO_SIDED|95.0|0.03|0.95||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 60: P-value was calculated using Analysis of Variance (ANOVA) which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.95|0.03|0.035
70904829|NCT00474175|141298904|SUPERIORITY_OR_OTHER||Treatment difference|0.32||||0.173|TWO_SIDED|95.0|-0.14|0.78||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 60: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.78|-0.14|0.173
70904830|NCT00474175|141298904|SUPERIORITY_OR_OTHER||Treatment difference|0.18||||0.358|TWO_SIDED|95.0|-0.2|0.55||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 60: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.55|-0.20|0.358
70904831|NCT00474175|141298904|SUPERIORITY_OR_OTHER||Treatment difference|0.75||||0.135|TWO_SIDED|95.0|-0.23|1.72||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 120: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.72|-0.23|0.135
70904832|NCT00474175|141298904|SUPERIORITY_OR_OTHER||Treatment difference|0.48||||0.332|TWO_SIDED|95.0|-0.49|1.46||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 120: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.46|-0.49|0.332
70904833|NCT00474175|141298904|SUPERIORITY_OR_OTHER||Treatment difference|0.26||||0.517|TWO_SIDED|95.0|-0.53|1.06||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 120: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.06|-0.53|0.517
70904834|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.93|||<|0.001|TWO_SIDED|95.0|0.5|1.35||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||5 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.35|0.50|<0.001
70904835|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.55||||0.011|TWO_SIDED|95.0|0.13|0.97||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||5 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.97|0.13|0.011
70904836|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.38||||0.031|TWO_SIDED|95.0|0.03|0.72||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||5 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.72|0.03|0.031
70904837|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.78|||<|0.001|TWO_SIDED|95.0|0.33|1.23||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||10 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.23|0.33|<0.001
70904838|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.49||||0.031|TWO_SIDED|95.0|0.04|0.94||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||10 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.94|0.04|0.031
70904839|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.29||||0.119|TWO_SIDED|95.0|-0.07|0.66||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||10 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.66|-0.07|0.119
70904840|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.77||||0.002|TWO_SIDED|95.0|0.28|1.25||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||15 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.25|0.28|0.002
70904841|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.46||||0.061|TWO_SIDED|95.0|-0.02|0.95||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||15 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.95|-0.02|0.061
70904842|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.3||||0.131|TWO_SIDED|95.0|-0.09|0.7||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||15 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.70|-0.09|0.131
70904843|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.52||||0.044|TWO_SIDED|95.0|0.01|1.03||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||20 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.03|0.01|0.044
70904844|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.43||||0.099|TWO_SIDED|95.0|-0.08|0.93||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||20 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.93|-0.08|0.099
70904845|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.1||||0.647|TWO_SIDED|95.0|-0.32|0.51||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||20 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.51|-0.32|0.647
70904846|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.6||||0.023|TWO_SIDED|95.0|0.08|1.11||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||25 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.11|0.08|0.023
70904847|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.47||||0.072|TWO_SIDED|95.0|-0.04|0.98||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||25 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.98|-0.04|0.072
70904848|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.13||||0.551|TWO_SIDED|95.0|-0.29|0.55||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||25 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.55|-0.29|0.551
70904849|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.54||||0.047|TWO_SIDED|95.0|0.01|1.08||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||30 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.08|0.01|0.047
70904850|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.27||||0.316|TWO_SIDED|95.0|-0.26|0.81||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||30 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.81|-0.26|0.316
70904851|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.27||||0.224|TWO_SIDED|95.0|-0.17|0.71||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||30 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.71|-0.17|0.224
70904852|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.46||||0.099|TWO_SIDED|95.0|-0.09|1.01||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||40 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.01|-0.09|0.099
70904853|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.37||||0.186|TWO_SIDED|95.0|-0.18|0.92||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||40 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.92|-0.18|0.186
70904854|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.09||||0.684|TWO_SIDED|95.0|-0.35|0.54||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||40 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.54|-0.35|0.684
70904855|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.21||||0.452|TWO_SIDED|95.0|-0.34|0.76||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||50 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.76|-0.34|0.452
70904856|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.2||||0.479|TWO_SIDED|95.0|-0.35|0.75||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||50 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.75|-0.35|0.479
70904857|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.01||||0.955|TWO_SIDED|95.0|-0.44|0.46||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||50 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.46|-0.44|0.955
70904858|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.21||||0.465|TWO_SIDED|95.0|-0.36|0.79||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||60 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.79|-0.36|0.465
70904859|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.0||||0.992|TWO_SIDED|95.0|-0.57|0.58||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||60 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.58|-0.57|0.992
70904860|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.21||||0.376|TWO_SIDED|95.0|-0.26|0.68||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||60 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.68|-0.26|0.376
70904861|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.36||||0.229|TWO_SIDED|95.0|-0.22|0.93||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||70 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.93|-0.22|0.229
70904862|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.16||||0.581|TWO_SIDED|95.0|-0.41|0.74||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||70 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.74|-0.41|0.581
70904863|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.19||||0.422|TWO_SIDED|95.0|-0.28|0.66||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||70 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.66|-0.28|0.422
70904864|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.33||||0.271|TWO_SIDED|95.0|-0.26|0.91||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||80 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.91|-0.26|0.271
70904865|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.15||||0.612|TWO_SIDED|95.0|-0.43|0.73||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||80 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.73|-0.43|0.612
70904866|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.18||||0.465|TWO_SIDED|95.0|-0.3|0.65||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||80 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.65|-0.30|0.465
70904867|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.32||||0.29|TWO_SIDED|95.0|-0.27|0.91||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||90 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.91|-0.27|0.290
70904868|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.25||||0.412|TWO_SIDED|95.0|-0.34|0.83||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||90 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.83|-0.34|0.412
70904869|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.07||||0.769|TWO_SIDED|95.0|-0.41|0.55||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||90 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.55|-0.41|0.769
70904870|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.15||||0.61|TWO_SIDED|95.0|-0.43|0.74||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||100 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.74|-0.43|0.610
70904871|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.2||||0.511|TWO_SIDED|95.0|-0.39|0.78||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||100 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.78|-0.39|0.511
70904872|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|-0.04||||0.859|TWO_SIDED|95.0|-0.52|0.43||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||100 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.43|-0.52|0.859
70904873|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.26||||0.386|TWO_SIDED|95.0|-0.33|0.84||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||110 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.84|-0.33|0.386
70904874|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.17||||0.563|TWO_SIDED|95.0|-0.41|0.76||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||110 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.76|-0.41|0.563
70904875|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.09||||0.721|TWO_SIDED|95.0|-0.39|0.56||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||110 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.56|-0.39|0.721
70904876|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.1||||0.725|TWO_SIDED|95.0|-0.48|0.69||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||120 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.69|-0.48|0.725
70904877|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.06||||0.839|TWO_SIDED|95.0|-0.52|0.64||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||120 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.64|-0.52|0.839
70904878|NCT00474175|141298906|SUPERIORITY_OR_OTHER||Treatment difference|0.04||||0.855|TWO_SIDED|95.0|-0.43|0.52||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||120 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.52|-0.43|0.855
70904879|NCT00474175|141298907|SUPERIORITY_OR_OTHER||Treatment difference|0.17||||0.035|TWO_SIDED|95.0|0.01|0.33||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test with modified ridit scores, adjusted for site baseline pain intensity. Treatment difference (Benzocaine 20% versus Placebo) and the associated confidence interval were calculated based on the weighted Gamma statistic.||0.33|0.01|0.035
70904880|NCT00474175|141298907|SUPERIORITY_OR_OTHER||Treatment difference|0.16||||0.039|TWO_SIDED|95.0|0.0|0.33||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test with modified ridit scores, adjusted for site baseline pain intensity. Treatment difference (Benzocaine 10% versus Placebo) and the associated confidence interval were calculated based on the weighted Gamma statistic.||0.33|-0.00|0.039
70904881|NCT00474175|141298907|SUPERIORITY_OR_OTHER||Treatment difference|-0.01||||0.944|TWO_SIDED|95.0|-0.15|0.13||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test with modified ridit scores, adjusted for site baseline pain intensity. Treatment difference (Benzocaine 20% versus Benzocaine 10%) and the associated confidence interval were calculated based on the weighted Gamma statistic.||0.13|-0.15|0.944
70904882|NCT01622543|141298924|SUPERIORITY||Hazard Ratio (HR)|1.59||||0.046|TWO_SIDED|95.0|1.0|2.53|||Log Rank|||||2.53|1.00|0.046
70904883|NCT01622543|141298925|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||||||0.45
70904884|NCT01622543|141298926|SUPERIORITY||Odds Ratio (OR)|2.09||||0.06|TWO_SIDED|95.0|0.96|4.55|||Cochran-Mantel-Haenszel|||||4.55|0.96|0.06
70904885|NCT01622543|141298927|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.36|TWO_SIDED|95.0|0.78|1.98|||Log Rank|||||1.98|0.78|0.36
70904886|NCT02091739|141298932|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.031|=|0.004|TWO_SIDED|95.0|-0.15|0.03|||MMRM|||"A fixed sequence test procedure was used for the confirmatory analysis of the co-primary endpoints by comparing the least square (LS) means estimates of an mixed model repeated measurement (MMRM) model (2-sided, significance level alpha=0.05) between treatment groups in the following order:~1. IncobotulinumtoxinA 100 units versus (v) Placebo~2. IncobotulinumtoxinA 75 units v Placebo"||0.03|-0.15|= 0.004
70904887|NCT02091739|141298932|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.03|=|0.542|TWO_SIDED|95.0|-0.08|0.04|||MMRM|||"A fixed sequence test procedure was used for the confirmatory analysis of the co-primary endpoints by comparing the least square means estimates of an MMRM model (2-sided, significance level alpha=0.05) between treatment groups in the following order:~1. IncobotulinumtoxinA 100 units v Placebo~2. IncobotulinumtoxinA 75 units v Placebo"||0.04|-0.08|= 0.542
70904888|NCT02091739|141298933|SUPERIORITY||LS mean difference|0.58|STANDARD_ERROR_OF_MEAN|0.183|=|0.002|TWO_SIDED|95.0|0.22|0.94|||MMRM|||"A fixed sequence test procedure was used for the confirmatory analysis of the co-primary endpoints by comparing the least square means estimates of an MMRM model (2-sided, significance level alpha=0.05) between treatment groups in the following order:~1. IncobotulinumtoxinA 100 units v Placebo~2. IncobotulinumtoxinA 75 units v Placebo"||0.94|0.22|= 0.002
70904889|NCT02091739|141298933|SUPERIORITY||LS mean difference|0.35|STANDARD_ERROR_OF_MEAN|0.181|=|0.055|TWO_SIDED|95.0|-0.01|0.71|||MMRM|||"A fixed sequence test procedure was used for the confirmatory analysis of the co-primary endpoints by comparing the least square means estimates of an MMRM model (2-sided, significance level alpha=0.05) between treatment groups in the following order:~1. IncobotulinumtoxinA 100 units v Placebo~2. IncobotulinumtoxinA 75 units v Placebo"||0.71|-0.01|= 0.055
70904890|NCT00192023|141298948|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change to Week 8 Endpoint. Change = Endpoint minus baseline. Model: Change to Week 8=score at Week 8+treatment+site+treatment-by-site interaction. If treatment-by-site interaction isn't significant it will be removed from model.|ANCOVA|||Using an estimate of the common standard deviation of 13 points, the planned sample size will give about 80% power to detect a difference between the groups of 8 points on the SNAP-IV. The sample size was determined using a two-sided test with p=0.05, and assumes that up to 10% of patients will discontinue the study without providing post-baseline efficacy data in Study Period III.||||<0.001
70904891|NCT00192023|141298949|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||<0.001
70904892|NCT00192023|141298950|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.001
70904893|NCT00192023|141298951|SUPERIORITY_OR_OTHER|||||||0.836||95.0||||P-value for Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.836
70904894|NCT00192023|141298952|SUPERIORITY_OR_OTHER|||||||0.87||95.0||||P-value for Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.870
70904895|NCT00192023|141298953|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Oppositional Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.002
70904896|NCT00192023|141298953|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Cognitive Problems Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||<0.001
70904897|NCT00192023|141298953|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for Hyperactivity Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.022
70904898|NCT00192023|141298953|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for ADHD Index Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||<0.001
70904899|NCT00192023|141298954|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||P-value for Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.071
70904900|NCT00192023|141298955|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Oppositional Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.002
70904901|NCT00192023|141298955|SUPERIORITY_OR_OTHER|||||||0.113||95.0||||P-value for Cognitive Problems Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.113
70904902|NCT00192023|141298955|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-value for Hyperactivity Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.051
70904903|NCT00192023|141298955|SUPERIORITY_OR_OTHER|||||||0.061||95.0||||P-value for ADHD Index Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.061
70904904|NCT02912468|141298961|SUPERIORITY||LS mean difference|-0.89|||<|0.0001|TWO_SIDED|95.0|-1.07|-0.71|||ANCOVA|||Data were analyzed using a hybrid method of the worst-observation carried forward (WOCF) and multiple imputation (MI). The imputed completed data were analyzed by fitting ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-0.71|-1.07|<0.0001
70904905|NCT02912468|141298962|SUPERIORITY||LS mean difference|-2.06|||<|0.0001|TWO_SIDED|95.0|-2.43|-1.69|||ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-1.69|-2.43|<0.0001
70904906|NCT02912468|141298963|SUPERIORITY|Hierarchical testing procedure was used to control type I error. For regions outside of Japan, this first secondary endpoint was not tested unless both co-primary endpoints were significant at the 0.05 level. Hierarchical testing continued only when previous endpoint was statistically significant. For Japan submission, LMK was instead a co-primary endpoint which also had to be met before secondary endpoints were tested in the hierarchy. Last endpoint in hierarchy is Week 24 SNOT-22.|LS mean difference|-7.44|||<|0.0001|TWO_SIDED|95.0|-8.35|-6.53||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-6.53|-8.35|<.0001
70904907|NCT02912468|141298964|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-2.61|||<|0.0001|TWO_SIDED|95.0|-3.04|-2.17||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-2.17|-3.04|<.0001
70904908|NCT02912468|141298965|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|10.56|||<|0.0001|TWO_SIDED|95.0|8.79|12.34||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||12.34|8.79|<.0001
70904909|NCT02912468|141298966|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-1.12|||<|0.0001|TWO_SIDED|95.0|-1.31|-0.93||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-0.93|-1.31|<.0001
70904910|NCT02912468|141298967|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-21.12|||<|0.0001|TWO_SIDED|95.0|-25.17|-17.06||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-17.06|-25.17|<.0001
70904911|NCT02301156|141299024|SUPERIORITY|||||||0.0463|||||||Cochran-Mantel-Haenszel|P-value was estimated by Cochran-Mantel-Haenszel (CMH) test stratified by the randomization strata prior lines of therapy.||||||0.0463
70904912|NCT02301156|141299025|SUPERIORITY|||||||0.0159|||||||Cochran-Mantel-Haenszel|P-value was estimated by CMH test stratified by the randomization strata prior lines of therapy.||||||0.0159
70904913|NCT02301156|141299026|SUPERIORITY||Rate Difference|35.64|||<|0.0001|TWO_SIDED|95.0|21.39|49.88|||Cochran-Mantel-Haenszel|P-value was estimated using CMH test stratified by the randomization strata prior lines of therapy.|95% Confidence Interval (CI) was estimated using Clopper-Pearson method based on the binomial distribution.|||49.88|21.39|<0.0001
70904914|NCT02301156|141299027|SUPERIORITY||Hazard Ratio (HR)|0.573||||0.0961|TWO_SIDED|95.0|0.295|1.113|||Log Rank|P-value was estimated by stratified log rank test and the stratification was based on the randomization strata prior lines of therapy.|Stratified Hazard Ratio and 95% CI were estimated using Cox proportion hazard model and the stratification was based on the randomization strata prior lines of therapy.|||1.113|0.295|0.0961
70904915|NCT02301156|141299028|SUPERIORITY||Hazard Ratio (HR)|0.569||||0.1486|TWO_SIDED|95.0|0.263|1.234|||Log Rank|P-value was estimated by stratified log rank test and the stratification was based on the randomization strata prior lines of therapy.|Stratified Hazard Ratio and 95% CI were estimated using Cox proportion hazard model and the stratification was based on the randomization strata prior lines of therapy.|||1.234|0.263|0.1486
70904916|NCT02301156|141299029|SUPERIORITY||Hazard Ratio (HR)|2.163||||0.0004|TWO_SIDED|95.0|1.399|3.344|||Log Rank|P-value was estimated by stratified log rank test and the stratification was based on the randomization strata prior lines of therapy.|Stratified Hazard Ratio and 95% CI were estimated using Cox proportion hazard model and the stratification was based on the randomization strata prior lines of therapy.|||3.344|1.399|0.0004
70904917|NCT01103960|141299059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1881|STANDARD_ERROR_OF_MEAN|0.803||0.007||95.0|0.6082|3.7681||This was the first step in the closed testing procedure of multiple endpoints. The p-value was \<0.05 so this test was considered confirmatory. Proceeding to the next step was allowed, testing the same endpoint in the subgroup of Chinese patients.|ANCOVA|||A5 minus T80/A5||3.7681|0.6082|0.007
70904918|NCT01103960|141299060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9195|STANDARD_ERROR_OF_MEAN|0.9015||0.034||95.0|0.1443|3.6947||This was the second step in the closed testing procedure of multiple endpoints. The p-value was again \<0.05 so this test was also considered confirmatory.|ANCOVA|||A5 minus T80/A5||3.6947|0.1443|0.034
70904919|NCT01103960|141299061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4879|STANDARD_ERROR_OF_MEAN|1.1217|<|0.001||95.0|2.2807|6.695|||ANCOVA|||A5 minus T80/A5||6.6950|2.2807|<0.001
70904920|NCT02875834|141299074|OTHER||Mean Difference (Final Values)|0.904|||<|0.001|TWO_SIDED|95.0|0.876|0.933|||Mixed Models Analysis|||Results derived from a mixed effects model of log-transformed S-K levels. Fixed effects are: treatment group; visit; treatment-by-visit interaction; baseline S-K values (OLP and RTP); baseline eGFR; age category; country; baseline RAAS inhibitor, chronic kidney disease, heart failure, and diabetes mellitus statuses. Patient is a random effect. p-values given are for differences of LSMEANS. The back-transformation is to the original scale of the S-K measurement.||0.933|0.876|<0.001
70904921|NCT02875834|141299074|OTHER||Mean Difference (Final Values)|0.823|||<|0.001|TWO_SIDED|95.0|0.797|0.85|||Mixed Models Analysis|||||0.850|0.797|<0.001
70904922|NCT02875834|141299079|OTHER||Odds Ratio (OR)|6.3436|||<|0.001|TWO_SIDED|95.0|2.6866|14.9782|||Regression, Logistic|||Treatment group comparisons were made using a logistic regression model containing the following covariates: treatment group; both baseline S-K values (48-hours open-label initial phase and double-blind randomized phase); baseline eGFR (during 48-hour open-label initial phase); age category (\<55, 55-64, \>=65 years); country; baseline RAAS inhibitor, chronic kidney disease, heart failure, and diabetes mellitus statuses.||14.9782|2.6866|<0.001
70904923|NCT02875834|141299079|OTHER||Odds Ratio (OR)|18.1876|||<|0.001|TWO_SIDED|95.0|7.1591|46.2054|||Regression, Logistic|||||46.2054|7.1591|<0.001
70904924|NCT02875834|141299081|OTHER||Mean Difference (Final Values)|7.266|||<|0.001|TWO_SIDED|95.0|4.318|10.214|||Regression, Linear|||Results derived from a linear regression model with the following covariates: treatment group; baseline S-K values (Open-label phase and Randomized treatment phase); baseline eGFR; age category; country; baseline RAAS inhibitor, chronic kidney disease, heart failure, and diabetes mellitus statuses.||10.214|4.318|<0.001
70904925|NCT02875834|141299081|OTHER||Mean Difference (Final Values)|12.079|||<|0.001|TWO_SIDED|95.0|9.118|15.04|||Regression, Linear|||||15.040|9.118|<0.001
70904926|NCT02875834|141299084|OTHER||Hazard Ratio (HR)|0.443|||<|0.001|TWO_SIDED|95.0|0.2954|0.6631|||Regression, Cox|||Results derived from a Cox Proportional Hazards model with the following covariates: treatment group, both baseline S-K values (48-hours open-label initial phase and double-blind randomized phase), baseline eGFR, age category (\<55, 55-64, \>=65 years), country, baseline RAAS inhibitor, chronic kidney, disease heart failure, and diabetes mellitus statuses.||0.6631|0.2954|<0.001
70904927|NCT02875834|141299084|OTHER||Hazard Ratio (HR)|0.158|||<|0.001|TWO_SIDED|95.0|0.0992|0.2508|||Regression, Cox|||||0.2508|0.0992|<0.001
70904928|NCT01302938|141299101|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|-1.6|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-3.9|0.6||||||Change at Week 12: Analysis was performed using an analysis of covariance (ANCOVA) with term for treatment with baseline value as a covariate.||0.6|-3.9|
70904929|NCT01302938|141299102|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|29.4|STANDARD_ERROR_OF_MEAN|35.4|||TWO_SIDED|95.0|-47.8|106.6||||||Change at Week 1: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||106.6|-47.8|
70904930|NCT01302938|141299102|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|28.0|STANDARD_ERROR_OF_MEAN|38.9|||TWO_SIDED|95.0|-55.4|111.4||||||Change at Week 4: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||111.4|-55.4|
70904931|NCT01302938|141299102|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|43.0|STANDARD_ERROR_OF_MEAN|31.4|||TWO_SIDED|95.0|-24.2|110.3||||||Change at Week 12: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||110.3|-24.2|
70904932|NCT01302938|141299103|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-0.67|1.67||||||Change at Week 1: Non-parametric Hodges-Lehmann's method was used to obtain median difference and 95 percent (%) confidence intervals (CI).||1.67|-0.67|
70904933|NCT01302938|141299103|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.58|||||TWO_SIDED|95.0|-1.0|1.83||||||Change at Week 4: Non-parametric Hodges-Lehmann's method was used to obtain median difference and 95% CI.||1.83|-1.00|
70904934|NCT01302938|141299103|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-3.0|1.0||||||Change at Week 12: Non-parametric Hodges-Lehmann's method was used to obtain median difference and 95% CI.||1.00|-3.00|
70904935|NCT01302938|141299104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-1.3|1.8||||||Change at Week 1: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||1.8|-1.3|
70904936|NCT01302938|141299104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-2.2|0.9||||||Change at Week 4: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||0.9|-2.2|
70904937|NCT01302938|141299107|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-0.8|1.9||||||Change at Week 1: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||1.9|-0.8|
70904938|NCT01302938|141299107|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.4|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|-3.7|0.8||||||Change at Week 4: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||0.8|-3.7|
70904939|NCT01302938|141299107|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.9|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|95.0|-6.3|0.4||||||Change at Week 12: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||0.4|-6.3|
70904940|NCT01302938|141299110|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-10.0|STANDARD_ERROR_OF_MEAN|10.8|||TWO_SIDED|95.0|-33.2|13.2||||||Change at Week 12: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||13.2|-33.2|
70904941|NCT01302938|141299111|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|11.7|STANDARD_ERROR_OF_MEAN|8.6|||TWO_SIDED|95.0|-6.9|30.3||||||Change at Week 12; Coping Subscale: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||30.3|-6.9|
70904942|NCT01302938|141299111|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|8.0|STANDARD_ERROR_OF_MEAN|11.4|||TWO_SIDED|95.0|-16.7|32.7||||||Change at Week 12; Concern Subscale: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||32.7|-16.7|
70904943|NCT01302938|141299111|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|10.3|STANDARD_ERROR_OF_MEAN|10.9|||TWO_SIDED|95.0|-13.3|33.8||||||Change at Week 12; Sleep Subscale: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||33.8|-13.3|
70904944|NCT01302938|141299111|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|9.0|STANDARD_ERROR_OF_MEAN|9.3|||TWO_SIDED|95.0|-11.0|29.0||||||Change at Week 12; Total HRQL Score: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||29.0|-11.0|
70904945|NCT01302938|141299112|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|4.0|||||TWO_SIDED|95.0|-20.0|20.0||||||Change at Week 12; Social Subscale: Non-parametric Hodges-Lehmann's method was used to obtain median difference and 95% CI.||20.00|-20.00|
70904946|NCT01233609|141299131|SUPERIORITY||Mean Difference (Net)|-150.43|STANDARD_ERROR_OF_MEAN|71.37||0.035|TWO_SIDED||||||Mixed Models Analysis|degrees of freedom = 830|Right eye and Left Eye within each of the 2 treatment groups (Placebo and Valproic Acid) were combined to estimate the difference|||||0.035
70904947|NCT01233609|141299132|SUPERIORITY|||||||0.581|||||||Mixed Models Analysis|||||||0.581
70904948|NCT01233609|141299133|SUPERIORITY|||||||0.409|||||||Wilcoxon (Mann-Whitney)|||||||0.409
70904949|NCT01233609|141299134|SUPERIORITY|||||||0.229|||||||Wilcoxon (Mann-Whitney)|||||||0.229
70904950|NCT03017235|141299138|NON_INFERIORITY|The NI margin for the difference between treatments (NaP/MC Oral Solution minus PREPOPIK) was pre-specified at -8% (absolute). If NI was demonstrated for both the primary efficacy endpoint and the secondary efficacy endpoint for the right colon, and if the lower bound of the CI was above 0%, then superiority was declared for the primary endpoint. Thus, the pre-specified superiority analysis was conducted at a one-sided significance level of 2.5%.|Difference in percentage|6.3||||0.0067|TWO_SIDED|95.0|1.8|10.9||The above p-value was calculated for superiority and was based on the stratified percentage difference test, where the stratification weight is based on Cochran-Mantel-Haenszel-weight.|Weighted Percentage Difference|CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site||Difference in the percentage of subjects on NaP/MC or PREPOPIK (NaP/MC - PREPOPIK)|Lower limit of 95% CI \> 0% for the primary efficacy endpoint combined with outcome of secondary efficacy endpoint for the right colon allowed for superiority analysis.|10.9|1.8|0.0067
70904951|NCT03017235|141299139|NON_INFERIORITY|If the lower limit of the 95% CI was greater than the margin (-8%), the null hypothesis was rejected and NaP/MC Oral Solution was claimed as non-inferior to PREPOPIK with respect to right colon cleansing in preparation for colonoscopy.|Difference in percentage|4.6||||0.0099|TWO_SIDED|95.0|1.1|8.0||The p-value was calculated for superiority and was based on the stratified percentage difference test, where the stratification weight is based on Cochran-Mantel-Haenszel-weight.|Weighted Percentage Difference|CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site||Difference in the percentage of subjects on NaP/MC or PREPOPIK (NaP/MC - PREPOPIK)||8.0|1.1|0.0099
70904952|NCT03017235|141299140|NON_INFERIORITY|If the lower limit of the 95% CI was greater than the margin (-8%), the null hypothesis was rejected and NaP/MC Oral Solution was claimed as non-inferior to PREPOPIK with respect to right colon cleansing in preparation for colonoscopy.|Difference in percentage|1.9||||0.1781|TWO_SIDED|95.0|-0.9|4.7||The above p-value was tested for superiority and was based on the stratified percentage difference test, where the stratification weight is based on Cochran Mantel Haenszel weight.|Weighted Percentage Difference|CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site||Difference in percentage of subjects on NaP/MC Oral Solution or PREPOPIK® (NaP/MC - PREPOPIK)||4.7|-0.9|0.1781
70904953|NCT03017235|141299141|NON_INFERIORITY|If the lower limit of the 95% CI was greater than the margin (-8%), the null hypothesis was rejected and NaP/MC Oral Solution was claimed as non-inferior to PREPOPIK with respect to colon cleansing in preparation for colonoscopy.|Difference in percentage|3.5||||0.0391|TWO_SIDED|95.0|0.2|6.7||The above p-value was for superiority and was based on the stratified percentage difference, where the stratification weight is based on Cochran-Mantel-Haenszel weight.|Weighted Percentage Difference|CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site||Difference in percentage of subjects on NaP/MC Oral Solution or PREPOPIK® (NaP/MC-PREPOPIK®)||6.7|0.2|0.0391
70904954|NCT02248961|141299175|OTHER|It was calculated that at least 140 patients (70 patients per group) must be enrolled into the study to achieve 80% power. With regard to 20% of patients withdrawn prematurely or data not suitable for analysis, it was necessary to include at least 176 patients (88 per group) into the study.|Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|1.0|=|0.39|ONE_SIDED|95.0||1.47|||Mixed Models Analysis|||"The null hypothesis (H0) is that there is a decrease in SBP on the background treatment with Kanarb (fimasartan), that is at least 5.5 mmHg lower compared to Cozaar® (losartan).~Test of the hypotheses was performed using mixed linear models, where the site effect was considered a random effect, and the treatment group effect was considered a fixed effect. Baseline SBP on the study arm was included into the model as a covariate (a fixed effect) in all cases."||1.47||=0.390
70904955|NCT02248961|141299176|OTHER||||||=|0.018|||||||Mixed Models Analysis|The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.||||||=0.018
70904956|NCT02248961|141299177|OTHER||||||=|0.579|||||||Mixed Models Analysis|The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.||||||=0.579
70904957|NCT02248961|141299178|OTHER||||||=|0.466|||||||Mixed Models Analysis|The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.||||||=0.466
70904958|NCT02248961|141299179|OTHER||||||=|0.118|||||||Mixed Models Analysis|The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.||||||=0.118
70904959|NCT02248961|141299180|OTHER||||||=|0.662|||||||Mixed Models Analysis|The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.||||||=0.662
70904960|NCT02248961|141299181|OTHER||||||=|0.143|||||||Mantel Haenszel|||||||=0.143
70904961|NCT01288781|141299182|SUPERIORITY_OR_OTHER|||||||0.98||||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||0.98
70904962|NCT01288781|141299183|SUPERIORITY_OR_OTHER|||||||0.63||95.0||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||0.63
70904963|NCT01288781|141299184|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||0.20
70904964|NCT01288781|141299185|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||<0.01
70904965|NCT01288781|141299185|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Step down Holm Bonferroni correction was applied|t-test, 2 sided|||Post hoc follow up test. T test between acetazolamide and placebo on data at 24 hr time point.||||<0.01
70904966|NCT01288781|141299186|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||0.98
70904967|NCT01288781|141299187|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||0.98
70904968|NCT01288781|141299188|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||0.98
70904969|NCT02444988|141299190|SUPERIORITY||Odds Ratio (OR)|0.87|||<|0.05|TWO_SIDED|95.0|0.77|0.99|||Regression, Logistic|||||0.99|0.77|<0.05
70904970|NCT02444988|141299191|SUPERIORITY||Odds Ratio (OR)|0.84|||<|0.05|TWO_SIDED|95.0|0.73|0.97|||Regression, Logistic|||||0.97|0.73|<0.05
70904971|NCT01976364|141299209|OTHER||Least Squares (LS) Mean difference|0.0255|||||TWO_SIDED|95.0|-0.0513|0.1022||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Analysis was based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1022|-0.0513|
70904972|NCT01976364|141299210|OTHER||LS mean difference|0.091|||||TWO_SIDED|95.0|-0.131|0.313||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.313|-0.131|
70904973|NCT01976364|141299244|OTHER||LS Mean Difference|0.0486|||||TWO_SIDED|95.0|-0.0192|0.1163||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1163|-0.0192|
70904974|NCT01976364|141299244|OTHER||LS Mean Difference|0.0325|||||TWO_SIDED|95.0|-0.0372|0.1021||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1021|-0.0372|
70904975|NCT01976364|141299244|OTHER||LS Mean Difference|-0.0058|||||TWO_SIDED|95.0|-0.0941|0.0825||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.0825|-0.0941|
70904976|NCT01976364|141299244|OTHER||LS Mean Difference|0.0096|||||TWO_SIDED|95.0|-0.0734|0.0927||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.0927|-0.0734|
70904977|NCT01976364|141299245|OTHER||LS Mean Difference|0.032|||||TWO_SIDED|95.0|-0.163|0.227||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.227|-0.163|
70904978|NCT01976364|141299245|OTHER||LS Mean Difference|-0.024|||||TWO_SIDED|95.0|-0.266|0.219||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.219|-0.266|
70904979|NCT01976364|141299245|OTHER||LS Mean Difference|0.213|||||TWO_SIDED|95.0|-0.045|0.47||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.470|-0.045|
70904980|NCT01976364|141299245|OTHER||LS Mean Difference|-0.061|||||TWO_SIDED|95.0|-0.309|0.188||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.188|-0.309|
70904981|NCT01976364|141299246|OTHER||Difference in percentage of participants|-0.14|||||TWO_SIDED|95.0|-9.76|9.48||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 1: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||9.48|-9.76|
70904982|NCT01976364|141299246|OTHER||Difference in percentage of participants|-4.57|||||TWO_SIDED|95.0|-12.91|3.77||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 3: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||3.77|-12.91|
70904983|NCT01976364|141299246|OTHER||Difference in percentage of participants|-5.69|||||TWO_SIDED|95.0|-14.26|2.87||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 6: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||2.87|-14.26|
70904984|NCT01976364|141299246|OTHER||Difference in percentage of participants|-2.36|||||TWO_SIDED|95.0|-11.59|6.87||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 9: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||6.87|-11.59|
70904985|NCT01976364|141299246|OTHER||Difference in percentage of participants|-10.15|||||TWO_SIDED|95.0|-18.16|-2.14||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 12: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||-2.14|-18.16|
70904986|NCT01976364|141299247|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-0.1|0.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.5|-0.1|
70904987|NCT01976364|141299247|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-0.1|0.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.6|-0.1|
70904988|NCT01976364|141299247|OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|0.0|0.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.6|0.0|
70904989|NCT01976364|141299247|OTHER||LS mean difference|0.5|||||TWO_SIDED|95.0|0.1|0.8||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.8|0.1|
70904990|NCT01976364|141299247|OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|-0.1|0.7||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.7|-0.1|
70904991|NCT01976364|141299248|OTHER||LS mean difference|-19.43|||||TWO_SIDED|95.0|-58.06|19.21||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||19.21|-58.06|
70904992|NCT01976364|141299248|OTHER||LS mean difference|-30.11|||||TWO_SIDED|95.0|-83.58|23.37||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||23.37|-83.58|
70904993|NCT01976364|141299248|OTHER||LS mean difference|-24.33|||||TWO_SIDED|95.0|-83.35|34.69||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||34.69|-83.35|
70904994|NCT01976364|141299248|OTHER||LS mean difference|-11.64|||||TWO_SIDED|95.0|-60.87|37.58||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||37.58|-60.87|
70904995|NCT01976364|141299248|OTHER||LS mean difference|7.02|||||TWO_SIDED|95.0|-49.73|63.77||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||63.77|-49.73|
70904996|NCT01976364|141299250|OTHER||Difference in percentage of participants|6.25|||||TWO_SIDED|95.0|-59.58|72.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 1: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||72.08|-59.58|
70904997|NCT01976364|141299250|OTHER||Difference in percentage of participants|6.25|||||TWO_SIDED|95.0|-59.58|72.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 3: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||72.08|-59.58|
70904998|NCT01976364|141299250|OTHER||Difference in percentage of participants|6.25|||||TWO_SIDED|95.0|-59.58|72.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 6: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||72.08|-59.58|
70904999|NCT01976364|141299250|OTHER||Difference in percentage of participants|6.25|||||TWO_SIDED|95.0|-59.58|72.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 9: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||72.08|-59.58|
70905000|NCT01976364|141299250|OTHER||Difference in percentage of participants|6.25|||||TWO_SIDED|95.0|-59.58|72.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 12: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||72.08|-59.58|
70905001|NCT01976364|141299251|OTHER||LS mean difference|-0.2|||||TWO_SIDED|95.0|-0.9|0.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.5|-0.9|
70905002|NCT01976364|141299251|OTHER||LS mean difference|-0.2|||||TWO_SIDED|95.0|-0.9|0.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.5|-0.9|
70905003|NCT01976364|141299251|OTHER||LS mean difference|-0.2|||||TWO_SIDED|95.0|-1.1|0.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.6|-1.1|
70905004|NCT01976364|141299251|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-0.6|1.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.1|-0.6|
70905005|NCT01976364|141299251|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-0.6|1.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.0|-0.6|
70905006|NCT01976364|141299253|OTHER||Difference in percentage of participants|11.67|||||TWO_SIDED|95.0|-15.65|38.98||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 1: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||38.98|-15.65|
70905007|NCT01976364|141299253|OTHER||Difference in percentage of participants|30.42|||||TWO_SIDED|95.0|0.64|60.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 3: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||60.20|0.64|
70905008|NCT01976364|141299253|OTHER||Difference in percentage of participants|29.58|||||TWO_SIDED|95.0|-3.46|62.62||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 6: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||62.62|-3.46|
70905009|NCT01976364|141299253|OTHER||Difference in percentage of participants|24.17|||||TWO_SIDED|95.0|-5.14|53.47||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 9: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||53.47|-5.14|
70905010|NCT01976364|141299253|OTHER||Difference in percentage of participants|17.08|||||TWO_SIDED|95.0|-15.96|50.12||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 12: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||50.12|-15.96|
70905011|NCT01976364|141299254|OTHER||Difference in percentage of participants|4.99|||||TWO_SIDED|95.0|-9.61|19.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 1: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||19.60|-9.61|
70905012|NCT01976364|141299254|OTHER||Difference in percentage of participants|3.88|||||TWO_SIDED|95.0|-10.74|18.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 3: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||18.50|-10.74|
70905013|NCT01976364|141299254|OTHER||Difference in percentage of participants|2.82|||||TWO_SIDED|95.0|-11.8|17.45||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 6: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||17.45|-11.80|
70905014|NCT01976364|141299254|OTHER||Difference in percentage of participants|3.97|||||TWO_SIDED|95.0|-10.58|18.52||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 9: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||18.52|-10.58|
70905015|NCT01976364|141299254|OTHER||Difference in percentage of participants|2.87|||||TWO_SIDED|95.0|-11.63|17.37||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 12: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||17.37|-11.63|
70905016|NCT01976364|141299255|OTHER||LS mean difference|-0.4|||||TWO_SIDED|95.0|-1.5|0.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.6|-1.5|
70905017|NCT01976364|141299255|OTHER||LS mean difference|-0.4|||||TWO_SIDED|95.0|-1.6|0.8||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.8|-1.6|
70905018|NCT01976364|141299255|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-1.0|1.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.0|-1.0|
70905019|NCT01976364|141299255|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.9|0.9||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.9|-0.9|
70905020|NCT01976364|141299255|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-0.7|1.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.1|-0.7|
70905021|NCT01976364|141299256|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.3|0.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.5|-0.3|
70905022|NCT01976364|141299256|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.6|0.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.6|-0.6|
70905023|NCT01976364|141299256|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.4|0.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.5|-0.4|
70905024|NCT01976364|141299256|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-0.3|0.7||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.7|-0.3|
70905025|NCT01976364|141299256|OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-0.5|0.3||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.3|-0.5|
70905026|NCT01976364|141299257|OTHER||LS mean difference|0.26|||||TWO_SIDED|95.0|-2.51|3.02||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||3.02|-2.51|
70905027|NCT01976364|141299257|OTHER||LS mean difference|0.77|||||TWO_SIDED|95.0|-2.64|4.18||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||4.18|-2.64|
70905028|NCT01976364|141299257|OTHER||LS mean difference|0.47|||||TWO_SIDED|95.0|-2.26|3.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||3.20|-2.26|
70905029|NCT01976364|141299257|OTHER||LS mean difference|2.18|||||TWO_SIDED|95.0|-1.46|5.81||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||5.81|-1.46|
70905030|NCT01976364|141299257|OTHER||LS mean difference|-0.12|||||TWO_SIDED|95.0|-3.25|3.01||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||3.01|-3.25|
70905031|NCT01976364|141299258|OTHER||LS mean difference|-2.03|||||TWO_SIDED|95.0|-5.58|1.52||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.52|-5.58|
70905032|NCT01976364|141299258|OTHER||LS mean difference|-0.43|||||TWO_SIDED|95.0|-4.69|3.84||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||3.84|-4.69|
70905033|NCT01976364|141299258|OTHER||LS mean difference|1.29|||||TWO_SIDED|95.0|-3.48|6.06||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||6.06|-3.48|
70905034|NCT01976364|141299258|OTHER||LS mean difference|0.64|||||TWO_SIDED|95.0|-4.03|5.32||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||5.32|-4.03|
70905035|NCT01976364|141299258|OTHER||LS mean difference|-0.13|||||TWO_SIDED|95.0|-4.64|4.38||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||4.38|-4.64|
70905036|NCT01976364|141299259|OTHER||LS mean difference|-1.11|||||TWO_SIDED|95.0|-4.96|2.74||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.74|-4.96|
70905037|NCT01976364|141299259|OTHER||LS mean difference|-1.23|||||TWO_SIDED|95.0|-5.11|2.65||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.65|-5.11|
70905038|NCT01976364|141299259|OTHER||LS mean difference|0.95|||||TWO_SIDED|95.0|-3.78|5.69||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||5.69|-3.78|
70905039|NCT01976364|141299259|OTHER||LS mean difference|2.01|||||TWO_SIDED|95.0|-2.92|6.93||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||6.93|-2.92|
70905040|NCT01976364|141299259|OTHER||LS mean difference|0.66|||||TWO_SIDED|95.0|-4.03|5.35||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||5.35|-4.03|
70905041|NCT01976364|141299260|OTHER||LS mean difference|-0.1535|||||TWO_SIDED|95.0|-2.1444|1.8374||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.8374|-2.1444|
70905042|NCT01976364|141299260|OTHER||LS mean difference|-0.566|||||TWO_SIDED|95.0|-1.9054|0.7735||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.7735|-1.9054|
70905043|NCT01976364|141299260|OTHER||LS mean difference|-0.7991|||||TWO_SIDED|95.0|-3.0053|1.4071||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.4071|-3.0053|
70905044|NCT01976364|141299260|OTHER||LS mean difference|0.0626|||||TWO_SIDED|95.0|-1.5767|1.7018||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.7018|-1.5767|
70905045|NCT01976364|141299260|OTHER||LS mean difference|0.3672|||||TWO_SIDED|95.0|-1.8107|2.545||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.5450|-1.8107|
70905046|NCT01976364|141299261|OTHER||LS mean difference|0.33|||||TWO_SIDED|95.0|-0.85|1.51||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.51|-0.85|
70967406|NCT01431274|141440929|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.178|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.127|0.228||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.228|0.127|<0.0001
70905047|NCT01976364|141299261|OTHER||LS mean difference|0.33|||||TWO_SIDED|95.0|-1.04|1.69||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.69|-1.04|
70905048|NCT01976364|141299261|OTHER||LS mean difference|-0.77|||||TWO_SIDED|95.0|-2.09|0.55||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.55|-2.09|
70905049|NCT01976364|141299261|OTHER||LS mean difference|-0.77|||||TWO_SIDED|95.0|-2.44|0.91||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.91|-2.44|
70905050|NCT01976364|141299261|OTHER||LS mean difference|0.52|||||TWO_SIDED|95.0|-0.96|2.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.00|-0.96|
70905051|NCT01976364|141299262|OTHER||LS mean difference|-0.47|||||TWO_SIDED|95.0|-2.22|1.29||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.29|-2.22|
70905052|NCT01976364|141299262|OTHER||LS mean difference|-0.86|||||TWO_SIDED|95.0|-2.65|0.92||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.92|-2.65|
70905053|NCT01976364|141299262|OTHER||LS mean difference|-0.66|||||TWO_SIDED|95.0|-2.68|1.36||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.36|-2.68|
70905054|NCT01976364|141299262|OTHER||LS mean difference|0.76|||||TWO_SIDED|95.0|-1.31|2.83||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.83|-1.31|
70905055|NCT01976364|141299262|OTHER||LS mean difference|-0.09|||||TWO_SIDED|95.0|-2.01|1.84||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.84|-2.01|
70905056|NCT01976364|141299263|OTHER||LS mean difference|0.22|||||TWO_SIDED|95.0|-1.09|1.53||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.53|-1.09|
70905057|NCT01976364|141299263|OTHER||LS mean difference|0.17|||||TWO_SIDED|95.0|-1.39|1.73||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.73|-1.39|
70905058|NCT01976364|141299263|OTHER||LS mean difference|-0.53|||||TWO_SIDED|95.0|-2.15|1.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.08|-2.15|
70905059|NCT01976364|141299263|OTHER||LS mean difference|0.32|||||TWO_SIDED|95.0|-1.49|2.13||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.13|-1.49|
70905060|NCT01976364|141299263|OTHER||LS mean difference|-0.01|||||TWO_SIDED|95.0|-1.89|1.86||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.86|-1.89|
70905061|NCT01976364|141299264|OTHER||LS mean difference|0.48|||||TWO_SIDED|95.0|-1.08|2.05||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.05|-1.08|
70905062|NCT01976364|141299264|OTHER||LS mean difference|1.25|||||TWO_SIDED|95.0|-0.49|2.99||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.99|-0.49|
70905063|NCT01976364|141299264|OTHER||LS mean difference|0.7|||||TWO_SIDED|95.0|-0.91|2.31||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.31|-0.91|
70905064|NCT01976364|141299264|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-1.57|1.96||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.96|-1.57|
70905065|NCT01976364|141299264|OTHER||LS mean difference|1.73|||||TWO_SIDED|95.0|-0.06|3.52||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||3.52|-0.06|
70905066|NCT01976364|141299265|OTHER||LS mean difference|0.71|||||TWO_SIDED|95.0|-1.01|2.42||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.42|-1.01|
70905067|NCT01976364|141299265|OTHER||LS mean difference|0.34|||||TWO_SIDED|95.0|-1.49|2.18||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.18|-1.49|
70905068|NCT01976364|141299265|OTHER||LS mean difference|-1.81|||||TWO_SIDED|95.0|-3.7|0.09||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.09|-3.70|
70905069|NCT01976364|141299265|OTHER||LS mean difference|-1.76|||||TWO_SIDED|95.0|-3.99|0.48||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.48|-3.99|
70905070|NCT01976364|141299265|OTHER||LS mean difference|-0.3|||||TWO_SIDED|95.0|-2.3|1.69||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.69|-2.30|
70905071|NCT01976364|141299266|OTHER||LS mean difference|-0.68|||||TWO_SIDED|95.0|-2.05|0.69||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.69|-2.05|
70905072|NCT01976364|141299266|OTHER||LS mean difference|-1.13|||||TWO_SIDED|95.0|-2.57|0.31||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.31|-2.57|
70905073|NCT01976364|141299266|OTHER||LS mean difference|-0.81|||||TWO_SIDED|95.0|-2.17|0.56||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.56|-2.17|
70905074|NCT01976364|141299266|OTHER||LS mean difference|0.01|||||TWO_SIDED|95.0|-1.54|1.57||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.57|-1.54|
70905075|NCT01976364|141299266|OTHER||LS mean difference|0.04|||||TWO_SIDED|95.0|-1.46|1.53||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.53|-1.46|
70905076|NCT01976364|141299267|OTHER||LS mean difference|-0.36|||||TWO_SIDED|95.0|-2.06|1.35||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.35|-2.06|
70905077|NCT01976364|141299267|OTHER||LS mean difference|-0.86|||||TWO_SIDED|95.0|-2.51|0.79||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.79|-2.51|
70905078|NCT01976364|141299267|OTHER||LS mean difference|-1.71|||||TWO_SIDED|95.0|-3.66|0.23||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.23|-3.66|
70905079|NCT01976364|141299267|OTHER||LS mean difference|-0.47|||||TWO_SIDED|95.0|-2.25|1.32||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.32|-2.25|
70905080|NCT01976364|141299267|OTHER||LS mean difference|0.95|||||TWO_SIDED|95.0|-0.82|2.73||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.73|-0.82|
70905081|NCT01976364|141299268|OTHER||LS mean difference|0.78|||||TWO_SIDED|95.0|-1.27|2.82||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.82|-1.27|
70905082|NCT01976364|141299268|OTHER||LS mean difference|-0.38|||||TWO_SIDED|95.0|-2.46|1.71||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.71|-2.46|
70905083|NCT01976364|141299268|OTHER||LS mean difference|-0.57|||||TWO_SIDED|95.0|-2.72|1.57||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.57|-2.72|
70905084|NCT01976364|141299268|OTHER||LS mean difference|0.28|||||TWO_SIDED|95.0|-1.81|2.36||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.36|-1.81|
70905085|NCT01976364|141299268|OTHER||LS mean difference|0.53|||||TWO_SIDED|95.0|-1.58|2.63||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.63|-1.58|
70905086|NCT01976364|141299269|OTHER||LS mean difference|-1.67|||||TWO_SIDED|95.0|-3.67|0.32||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.32|-3.67|
70905087|NCT01976364|141299269|OTHER||LS mean difference|-0.61|||||TWO_SIDED|95.0|-2.86|1.63||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.63|-2.86|
70905088|NCT01976364|141299269|OTHER||LS mean difference|-0.09|||||TWO_SIDED|95.0|-2.27|2.09||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.09|-2.27|
70905089|NCT01976364|141299269|OTHER||LS mean difference|0.73|||||TWO_SIDED|95.0|-1.49|2.95||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.95|-1.49|
70905090|NCT01976364|141299269|OTHER||LS mean difference|-0.79|||||TWO_SIDED|95.0|-3.1|1.53||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.53|-3.10|
70905091|NCT01976364|141299270|OTHER||LS mean difference|0.93|||||TWO_SIDED|95.0|-0.95|2.81||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.81|-0.95|
70905092|NCT01976364|141299270|OTHER||LS mean difference|0.11|||||TWO_SIDED|95.0|-1.72|1.95||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.95|-1.72|
70905093|NCT01976364|141299270|OTHER||LS mean difference|-0.25|||||TWO_SIDED|95.0|-2.4|1.9||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.90|-2.40|
70905094|NCT01976364|141299270|OTHER||LS mean difference|1.07|||||TWO_SIDED|95.0|-0.93|3.07||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||3.07|-0.93|
70905095|NCT01976364|141299270|OTHER||LS mean difference|0.38|||||TWO_SIDED|95.0|-1.62|2.38||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.38|-1.62|
70905096|NCT01976364|141299271|OTHER||LS mean difference|0.8|||||TWO_SIDED|95.0|-0.9|2.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.5|-0.9|
70905097|NCT01976364|141299271|OTHER||LS mean difference|0.5|||||TWO_SIDED|95.0|-1.1|2.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.2|-1.1|
70905098|NCT01976364|141299271|OTHER||LS mean difference|-0.7|||||TWO_SIDED|95.0|-2.4|1.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.0|-2.4|
70905099|NCT01976364|141299271|OTHER||LS mean difference|1.1|||||TWO_SIDED|95.0|-0.8|2.9||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.9|-0.8|
70905100|NCT01976364|141299271|OTHER||LS mean difference|0.8|||||TWO_SIDED|95.0|-1.1|2.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.6|-1.1|
70905101|NCT01976364|141299272|OTHER||LS mean difference|0.4|||||TWO_SIDED|95.0|-0.4|1.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.2|-0.4|
70905102|NCT01976364|141299272|OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-1.0|0.7||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.7|-1.0|
70905103|NCT01976364|141299272|OTHER||LS mean difference|-0.7|||||TWO_SIDED|95.0|-1.6|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-1.6|
70905104|NCT01976364|141299272|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.9|0.8||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.8|-0.9|
70905105|NCT01976364|141299272|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.9|0.8||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.8|-0.9|
70905106|NCT01976364|141299273|OTHER||LS mean difference|0.5|||||TWO_SIDED|95.0|-0.6|1.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.6|-0.6|
70905107|NCT01976364|141299273|OTHER||LS mean difference|0.7|||||TWO_SIDED|95.0|-0.3|1.7||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.7|-0.3|
70905108|NCT01976364|141299273|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-1.0|1.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.2|-1.0|
70905109|NCT01976364|141299273|OTHER||LS mean difference|1.2|||||TWO_SIDED|95.0|0.0|2.3||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.3|0.0|
70905110|NCT01976364|141299273|OTHER||LS mean difference|0.8|||||TWO_SIDED|95.0|-0.3|1.9||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.9|-0.3|
70905111|NCT01976364|141299274|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
70905112|NCT01976364|141299274|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
70905113|NCT01976364|141299274|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
70905114|NCT01976364|141299274|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
70905115|NCT01976364|141299274|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|0.0|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|0.0|
70905116|NCT01976364|141299275|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|0.0|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|0.0|
70905117|NCT01976364|141299275|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|0.0|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|0.0|
70905118|NCT01976364|141299275|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|0.0|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|0.0|
70905119|NCT01976364|141299275|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.1|
70905120|NCT01976364|141299275|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.1|
70905121|NCT01976364|141299276|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.1|
70905122|NCT01976364|141299276|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
70905123|NCT01976364|141299276|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|0.0|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|0.0|
70905124|NCT01976364|141299276|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.1|
70905125|NCT01976364|141299276|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
70905126|NCT01976364|141299277|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.1|
70905127|NCT01976364|141299277|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
70905128|NCT01976364|141299277|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.1|
70905129|NCT01976364|141299277|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
70905130|NCT01976364|141299277|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
70905131|NCT01976364|141299278|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.2|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.2|
70905132|NCT01976364|141299278|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.2|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.2|
70905133|NCT01976364|141299278|OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-0.2|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.2|
70905134|NCT01976364|141299278|OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-0.3|0.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.0|-0.3|
70905135|NCT01976364|141299278|OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-0.2|0.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.0|-0.2|
70905136|NCT01976364|141299279|OTHER||LS mean difference|-2.9|||||TWO_SIDED|95.0|-6.2|0.4||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.4|-6.2|
70905137|NCT01976364|141299279|OTHER||LS mean difference|-1.5|||||TWO_SIDED|95.0|-5.8|2.7||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.7|-5.8|
70905138|NCT01976364|141299279|OTHER||LS mean difference|-6.3|||||TWO_SIDED|95.0|-10.2|-2.4||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||-2.4|-10.2|
70905139|NCT01976364|141299279|OTHER||LS mean difference|-2.8|||||TWO_SIDED|95.0|-7.3|1.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.6|-7.3|
70905140|NCT01976364|141299279|OTHER||LS mean difference|-4.9|||||TWO_SIDED|95.0|-9.9|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-9.9|
70905141|NCT02318719|141299289|SUPERIORITY||Difference of least square mean|-0.41||||0.017|TWO_SIDED|95.0|-0.74|-0.07||DS-5565 20 mg and 30 mg vs placebo were tested at level of 0.025. If both were significant, 15 mg was tested at 0.05. If neither were significant, 15 mg was no longer tested. If either 20 mg or 30 mg was significant, 15 mg was tested at 0.025.|Mixed Models Analysis|||Placebo vs DS-5565 15 mg/day at Week 14||-0.07|-0.74|0.0170
70905142|NCT02318719|141299289|SUPERIORITY||Difference of least square means|-0.47||||0.0058|TWO_SIDED|95.0|-0.81|-0.14||DS-5565 20 mg and 30 mg vs placebo were tested at level of 0.025. If both were significant, 15 mg was tested at 0.05. If neither were significant, 15 mg was no longer tested. If either 20 mg or 30 mg was significant, 15 mg was tested at 0.025.|Mixed Models Analysis|||Placebo vs DS-5565 20 mg/day at Week 14||-0.14|-0.81|0.0058
70905143|NCT02318719|141299289|SUPERIORITY||Difference of least square means|-0.77|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.44||DS-5565 20 mg and 30 mg vs placebo were tested at level of 0.025. If both were significant, 15 mg was tested at 0.05. If neither were significant, 15 mg was no longer tested. If either 20 mg or 30 mg was significant, 15 mg was tested at 0.025.|Mixed Models Analysis|||Placebo vs DS-5565 30 mg/day at Week 14||-0.44|-1.10|<0.0001
70905144|NCT01928225|141299336|SUPERIORITY||Risk Ratio (RR)|1.18||||0.29|TWO_SIDED|95.0|0.87|1.6||\<0.05 was considered statistically significant.|Chi-squared|||||1.6|.87|.29
70905145|NCT01928225|141299337|SUPERIORITY||Risk Ratio (RR)|1.26||||0.22|TWO_SIDED|95.0|0.85|1.95|||Chi-squared|||||1.95|.85|.22
70905146|NCT04250337|141299338|SUPERIORITY||Risk Difference (RD)|18.3||||0.011|TWO_SIDED|95.0|5.1|31.5|||Cochran-Mantel-Haenszel|||||31.5|5.1|0.011
70905147|NCT04250337|141299339|SUPERIORITY||Risk Difference (RD)|26.4|||<|0.001|TWO_SIDED|95.0|12.1|40.8|||Cochran-Mantel-Haenszel|||||40.8|12.1|<.001
70905148|NCT04250337|141299340|SUPERIORITY||Risk Difference (RD)|18.9||||0.008|TWO_SIDED|95.0|6.1|31.7|||Cochran-Mantel-Haenszel|||||31.7|6.1|0.008
70905149|NCT04250337|141299341|SUPERIORITY||LS Mean Difference (Final Values)|-15.21|STANDARD_ERROR_OF_MEAN|6.373||0.017263|TWO_SIDED|95.0|-27.7|-2.7|||ANCOVA|||||-2.7|-27.7|0.017263
70905150|NCT04250337|141299342|SUPERIORITY||Risk Difference (RD)|19.2||||0.017|TWO_SIDED|95.0|4.3|34.1|||Cochran-Mantel-Haenszel|||||34.1|4.3|0.017
70905151|NCT04250337|141299343|SUPERIORITY||Risk Difference (RD)|21.6||||0.007|TWO_SIDED|95.0|7.1|36.1|||Cochran-Mantel-Haenszel|||||36.1|7.1|0.007
70905152|NCT04250337|141299344|SUPERIORITY||LS Mean Difference (Final Values)|-23.64|STANDARD_ERROR_OF_MEAN|5.074||3e-06|TWO_SIDED|95.0|-33.6|-13.7|||ANCOVA|||||-13.7|-33.6|0.000003
70905153|NCT04250337|141299345|SUPERIORITY||LS Mean Difference (Final Values)|-12.28|STANDARD_ERROR_OF_MEAN|2.428|<|0.001|TWO_SIDED|95.0|-17.07|-7.49|||Mixed Models Analysis|||||-7.49|-17.07|<0.001
70905154|NCT04250337|141299346|SUPERIORITY||Risk Difference (RD)|3.5||||0.454|TWO_SIDED|95.0|-4.9|11.8|||Cochran-Mantel-Haenszel|||||11.8|-4.9|0.454
70905155|NCT04250337|141299347|SUPERIORITY||Markov Chain Monte Carlo (MCMC)|-20.14|STANDARD_ERROR_OF_MEAN|12.81||0.117607|TWO_SIDED|95.0|-45.4|5.1|||ANCOVA|||||5.1|-45.4|0.117607
70905156|NCT04250337|141299348|SUPERIORITY||Markov Chain Monte Carlo (MCMC)|-0.3|STANDARD_ERROR_OF_MEAN|0.134||0.025293|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||-0.0|-0.6|0.025293
70905157|NCT04250337|141299349|SUPERIORITY||Risk Difference (RD)|14.2||||0.022|TWO_SIDED|95.0|3.8|24.7|||Cochran-Mantel-Haenszel|||||24.7|3.8|0.022
70905158|NCT04250337|141299350|SUPERIORITY||Risk Difference (RD)|1.2||||0.764|TWO_SIDED|95.0|-7.3|9.7|||Cochran-Mantel-Haenszel|||||9.7|-7.3|0.764
70905159|NCT04250337|141299351|SUPERIORITY||Risk Difference (RD)|1.9||||0.498|TWO_SIDED|95.0|-2.9|6.7|||Cochran-Mantel-Haenszel|||||6.7|-2.9|0.498
70905160|NCT04250337|141299352|SUPERIORITY||Risk Difference (RD)|15.6||||0.014|TWO_SIDED|95.0|5.3|25.9|||Cochran-Mantel-Haenszel|||||25.9|5.3|0.014
70905161|NCT04250337|141299353|SUPERIORITY||Risk Difference (RD)|1.1||||0.818|TWO_SIDED|95.0|-8.0|10.2|||Cochran-Mantel-Haenszel|||||10.2|-8.0|0.818
70905162|NCT04250337|141299354|SUPERIORITY||Risk Difference (RD)|2.0||||0.499|TWO_SIDED|95.0|-3.1|7.1|||Cochran-Mantel-Haenszel|||||7.1|-3.1|0.499
70905163|NCT04250337|141299355|SUPERIORITY||LS Mean Difference (Final Values)|7.29|STANDARD_ERROR_OF_MEAN|5.104||0.155|TWO_SIDED|95.0|-2.78|17.36|||Mixed Models Analysis|||||17.36|-2.78|0.155
70905164|NCT04250337|141299357|SUPERIORITY||LS Mean Difference (Final Values)|-17.69|STANDARD_ERROR_OF_MEAN|4.403|<|0.001|TWO_SIDED|95.0|-26.37|-9.01|||ANCOVA|||||-9.01|-26.37|<0.001
70905165|NCT04250337|141299358|SUPERIORITY||LS Mean Difference (Final Values)|-3.33|STANDARD_ERROR_OF_MEAN|1.014||0.001031|TWO_SIDED|95.0|-5.3|-1.3|||ANCOVA|||||-1.3|-5.3|0.001031
70905166|NCT04250337|141299359|SUPERIORITY||Risk Difference (RD)|17.2||||0.036|TWO_SIDED|95.0|0.1|34.3|||Cochran-Mantel-Haenszel|||||34.3|0.1|0.036
70905167|NCT04250337|141299360|SUPERIORITY||LS Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.025|<|0.001|TWO_SIDED|95.0|0.06|0.16|||ANCOVA|||Health State Index UK||0.16|0.06|<0.001
70905168|NCT04250337|141299360|SUPERIORITY||LS Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.018|<|0.001|TWO_SIDED|95.0|0.04|0.11|||ANCOVA|||Health State Index US||0.11|0.04|<0.001
70905169|NCT04250337|141299361|SUPERIORITY||LS Mean Difference (Final Values)|3.62|STANDARD_ERROR_OF_MEAN|2.386||0.131|TWO_SIDED|95.0|-1.08|8.32|||ANCOVA|||||8.32|-1.08|0.131
70905170|NCT04250337|141299362|SUPERIORITY||LS Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|1.145|<|0.001|TWO_SIDED|95.0|-6.26|-1.74|||Mixed Models Analysis|||||-1.74|-6.26|<0.001
70905171|NCT04250337|141299363|SUPERIORITY||LS Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|1.407||0.571|TWO_SIDED|95.0|-3.58|1.98|||ANCOVA|||||1.98|-3.58|0.571
70905172|NCT04250337|141299364|SUPERIORITY||LS Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|1.127||0.882|TWO_SIDED|95.0|-2.4|2.06|||ANCOVA|||||2.06|-2.40|0.882
70905173|NCT04250337|141299365|SUPERIORITY||LS Mean Difference (Final Values)|3.46|STANDARD_ERROR_OF_MEAN|2.48||0.171|TWO_SIDED|95.0|-1.56|8.48|||ANCOVA|||||8.48|-1.56|0.171
70905174|NCT04250337|141299366|SUPERIORITY||LS Mean Difference (Final Values)|4.43|STANDARD_ERROR_OF_MEAN|2.697||0.109|TWO_SIDED|95.0|-1.03|9.89|||ANCOVA|||||9.89|-1.03|0.109
70905175|NCT04250337|141299367|SUPERIORITY||LS Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.116||0.922|TWO_SIDED|95.0|-0.22|0.24|||ANCOVA|||||0.24|-0.22|0.922
70905176|NCT04250337|141299368|SUPERIORITY||LS Mean Difference (Final Values)|-4.62|STANDARD_ERROR_OF_MEAN|1.271||0.001|TWO_SIDED|95.0|-7.22|-2.03|||Mixed Models Analysis|||||-2.03|-7.22|0.001
70905177|NCT00365378|141299376|SUPERIORITY_OR_OTHER||Vaccine Efficacy|94.3||||||95.0|87.8|97.7|||||"Vaccine Efficacy (% relative risk reduction)~Confidence Interval based on binomial tail probabilities and not from a dispersion parameter."|||97.7|87.8|
70905178|NCT00365378|141299377|SUPERIORITY_OR_OTHER||Vaccine Efficacy|100.0||||||95.0|84.0|100.0|||||"Vaccine Efficacy (% relative risk reduction)~Confidence Interval based on binomial tail probabilities and not from a dispersion parameter."|||100.0|84.0|
70905179|NCT02006121|141299425|SUPERIORITY|||||||0.0047|||||||Mixed Models Analysis|||||||0.0047
70905180|NCT02006121|141299426|SUPERIORITY|||||||0.0022|||||||Mixed Models Analysis|||||||0.0022
70905181|NCT02006121|141299427|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
70905182|NCT02006121|141299428|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|||||||0.005
70905183|NCT02006121|141299429|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
70905184|NCT01614847|141299454|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.4|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.4
70905185|NCT01614847|141299454|EQUIVALENCE|two-tailed, alpha = 0.05||||||0.109|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.109
70905186|NCT01614847|141299454|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.779|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.779
70905187|NCT01614847|141299454|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.262|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.262
70905188|NCT01614847|141299454|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.15|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.150
70905189|NCT01614847|141299454|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.726|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.726
70905190|NCT01614847|141299454|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.055|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.055
70905191|NCT01614847|141299454|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.945|||||||Wilcoxon (Mann-Whitney)|df=7||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.945
70905192|NCT01614847|141299454|EQUIVALENCE|Alpha = 0.05||||||0.844|||||||Wilcoxon (Mann-Whitney)|df=7||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.844
70905193|NCT01614847|141299454|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.945||||||df=7|Wilcoxon (Mann-Whitney)|||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.945
70905194|NCT01614847|141299454|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.383||||||Alpha = 0.05|Wilcoxon (Mann-Whitney)|df=7||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.383
70905195|NCT01614847|141299454|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.383|||||||Wilcoxon (Mann-Whitney)|df=7||Mean change in osmolarity from baseline. H0: No change (e.g. mean change = 0) H1: Significant change (mean change ≠ 0)||||0.383
70905196|NCT01614847|141299454|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.672|||||||Wilcoxon (Mann-Whitney)|df=7||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.672
70905197|NCT01614847|141299454|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.107|||||||Wilcoxon (Mann-Whitney)|df=7||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.107
70905198|NCT01614847|141299454|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.64|||||||Wilcoxon (Mann-Whitney)|df=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.64
70905199|NCT01614847|141299454|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.04|||||||Wilcoxon (Mann-Whitney)|df=14||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.040
70905200|NCT01614847|141299454|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.2|||||||Wilcoxon (Mann-Whitney)|df=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.20
70905201|NCT01614847|141299454|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.15|||||||Wilcoxon (Mann-Whitney)|df-=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.150
70905202|NCT01614847|141299454|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.73|||||||Wilcoxon (Mann-Whitney)|df=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.730
70905203|NCT01614847|141299454|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.89|||||||Wilcoxon (Mann-Whitney)|df=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.89
70905204|NCT01614847|141299454|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.89|||||||Wilcoxon (Mann-Whitney)|df=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.89
70905205|NCT00249496|141299456|SUPERIORITY||Odds Ratio (OR)|3.73||||0.004|TWO_SIDED|95.0|1.6|8.69|||General Estimating Equation (GEE)|||||8.69|1.60|.004
70905206|NCT00249496|141299458|SUPERIORITY||Odds Ratio (OR)|0.8|||=|0.57|TWO_SIDED|95.0|0.26|2.43|||General Estimating Equation (GEE)|||||2.43|0.26|=0.57
70905207|NCT00249496|141299460|SUPERIORITY||Odds Ratio (OR)|0.0||||0.046|TWO_SIDED|95.0|0.0|0.0|||General Estimating Equation (GEE)||The Odds Ratio and Confidence Intervals could not be calculated because one of the groups was at 0.|||0|0|0.046
70905208|NCT02693834|141299461|OTHER|Paired t test||||||0.293|||||||t-test, 2 sided|||In order to test the difference in gait endurance,between the two AFO conditions at baseline, a paired t-test was analyzed||||.293
70905209|NCT02693834|141299462|OTHER|Repeated measures ANOVA||||||0.077||||||The above value was the interaction between the type of AFO and practice time.|repeated measures ANOVA|||A repeated measures ANOVA was calculated to find the differences in gait endurance between the type of AFO and practice time.||||0.077
70905210|NCT02693834|141299462|OTHER|Repeated measures ANOVA||||||0.046||||||main effect of the type of AFO: F(1, 19) = 4.58, ηp2= .194|repeated measures ANOVA|||The main effect of type of AFO||||.046
70905211|NCT02693834|141299462|OTHER|Repeated measures ANOVA|||||<|0.001||||||main effect of practice: F(1, 19) = 43.94, ηp2 = .698|repeated measures ANOVA|||Main effect of practice||||<.001
70905212|NCT02693834|141299463|OTHER|paired t test||||||0.688|||||||t-test, 2 sided|||The significance of differences in gait symmetry, between the two AFO conditions at baseline were analyzed using a paired t test for self selected velocity||||.688
70905213|NCT02693834|141299463|OTHER|repeated measures MANOVA||||||0.397||||||The above p value is for the interaction effects between type of AFO and practice time for gait symmetry at the self selected velocity F(1, 19)= 0.75, ηp2 = .038|repeated measures MANOVA|||The significance of differences in gait symmetry at self select velocity, between the two AFO conditions and two practice conditions were analyzed using repeated measures MANOVA.||||.397
70905214|NCT02693834|141299463|OTHER|A repeated measures MANOVA||||||0.95||||||Main effect of AFO on gait symmetry at SSV: F(1, 19) = 0.004, ηp2 =.00|Repeated measures MANOVA|||Main effect of AFO on gait symmetry was analyzed at self selected velocity||||.950
70905215|NCT02693834|141299463|OTHER|Repeated measures MANOVA||||||0.111||||||The main effect of practice on gait symmetry at self selected velocity F(1, 19) = 2.79, ηp2 = .128|repeated measures MANOVA|||Main effect of practice on gait symmetry at Self selected velocity||||.111
70905216|NCT02693834|141299463|OTHER|||||||0.26|||||||t-test, 2 sided|||The significance of differences in gait symmetry, between the two AFO conditions at baseline were analyzed using a paired t test for fast paced velocity||||.260
70905217|NCT02693834|141299463|OTHER|repeated measures MANOVA||||||0.113||||||The above p value is for the interaction effects between type of AFO and practice time for gait symmetry at fast paced velocity FPV F(1, 19) = 2.76,, ηp2 = .127|repeated measures MANOVA|||The significance of differences in gait symmetry at fast paced velocity, between the two AFO conditions and two practice conditions were analyzed using repeated measures MANOVA||||.113
70905218|NCT02693834|141299463|OTHER|Repeated measures MANOVA||||||0.918||||||The main effect of AFO on gait symmetry at fast paced velocity: F(1, 19) = 0.01, ηp2 = 0.001|repeated measures MANOVA|||The main effect of AFO on gait symmetry at fast paced velocity walk was assessed with repeated measures MANOVA||||.918
70905219|NCT02693834|141299463|OTHER|Repeated measures MANOVA||||||0.077||||||The main effect of practice on gait symmetry at fast paced velocity: F(1, 19) = 3.50, ηp2 = .155|repeated measures MANOVA|||The main effect of practice on gait symmetry at fast paced velocity walk was assessed with repeated measures MANOVA||||.077
70905220|NCT02693834|141299464|OTHER|A repeated measures MANOVA||||||0.209||||||The above p value is for the interaction effects between the type of AFO and practice time at self selected velocity: F(1, 19) = 1.69, ηp2 = .082|Repeated measures MANOVA|||The significance of differences in gait velocity at self select velocity, between the two AFO conditions and two practice conditions were analyzed using repeated measures MANOVA.||||.209
70905221|NCT02693834|141299464|OTHER|Repeated measures MANOVA||||||0.32||||||Main effect of AFO on gait velocity at self selected velocity: F(1, 19) = 1.05, ηp2 = .05|repeated measures MANOVA|||Main effect of AFO on gait velocity was analyzed at self selected velocity||||.32
70905222|NCT02693834|141299464|OTHER|Repeated measures MANOVA||||||0.001||||||Main effect of practice on gait velocity at self selected velocity:F(1, 19) = 14.38, ηp2 = .431|repeated measures MANOVA|||Main effect of Practice on gait velocity was analyzed at self selected velocity||||.001
70905223|NCT02693834|141299464|OTHER|repeated measures MANOVA||||||0.28||||||The above p value is for the interaction effects between the type of AFO and practice time at fast paced velocity: F( 1, 19) = 1.24, ηp2 = .61|repeated measures MANOVA|||The significance of differences in gait velocity at fast paced velocity, between the two AFO conditions and two practice conditions were analyzed using repeated measures MANOVA.||||.280
70905224|NCT02693834|141299464|OTHER|repeated measures MANOVA||||||0.072||||||Main effect of AFO on gait velocity was analyzed at self selected velocity:FPV F(1, 19) = 3.63, ηp2 =.16|repeated measures MANOVA|||Main effect of AFO on gait velocity was analyzed for self selected velocity||||.072
70905225|NCT02693834|141299464|OTHER|Repeated measures MANOVA|||||<|0.001||||||Main effect of Practice on gait velocity for fast paced velocity: F(1, 19) = 23.73, ηp2 = .555|repeated measures MANOVA|||Main effect of Practice on gait velocity was analyzed for fast paced velocity||||<.001
70905226|NCT01121484|141299493|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.|ANCOVA|||Null hypothesis: no difference between treatment groups||||0.004
70905227|NCT01121484|141299494|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CGI-I analyzed as a categorical variable by Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores, controlling for the effect of region; p-value obtained from the alternative hypothesis of Row Mean Score Differences.|Cochran-Mantel-Haenszel|||||||<0.001
70905228|NCT01121484|141299495|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.|ANCOVA|||||||0.002
70905229|NCT01121484|141299496|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.|ANCOVA|||||||0.002
70905230|NCT01121484|141299497|SUPERIORITY_OR_OTHER|||||||0.158|TWO_SIDED|||||Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.|ANCOVA|||||||0.158
70905231|NCT01121484|141299498|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.|ANCOVA|||||||<0.001
70905232|NCT03959592|141299567|OTHER|||||||0.14|||||||Generalized Estimating Equations|||||||0.14
70905233|NCT03959592|141299568|OTHER|||||||0.423|||||||Generalized Estimating Equations|||||||0.423
70905234|NCT03959592|141299571|OTHER|||||||0.985|||||||Generalized Estimating Equations|||||||0.985
70905235|NCT03959592|141299572|OTHER|||||||0.545|||||||Generalized Estimating Equations|||||||0.545
70905236|NCT01370005|141299597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.72|-0.52||Hierarchical testing, no adjustment of p-values.|ANCOVA|Model includes baseline HbA1c as lin. covariate and treatment, baseline renal function, region and baseline N of antihyperten. med. as fixed effects|Difference calculated as empa 10mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.||-0.52|-0.72|<0.0001
70905237|NCT01370005|141299597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.75|-0.55||Hierarchical testing, no adjustment of p-values|ANCOVA|Model includes baseline HbA1c as lin. covariate and treatment, baseline renal function, region and baseline N of antihyperten. med. as fixed effects|Difference calculated as empa 25mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.||-0.55|-0.75|<0.0001
70905238|NCT01370005|141299598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|0.69|<|0.0001|TWO_SIDED|95.0|-4.78|-2.09||Hierarchical testing, no adjustment of p-values.|ANCOVA|Model incl. baseline (bl) HbA1c, bl mean 24h SBP as lin. covariates; treatment, bl renal function, region, bl N of antihyperten. med. as fixed effects|Difference calculated as empa 10mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.||-2.09|-4.78|<0.0001
70905239|NCT01370005|141299598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.16|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001|TWO_SIDED|95.0|-5.5|-2.83||Hierarchical testing, no adjustment of p-values.|ANCOVA|Model incl. baseline (bl) HbA1c, bl mean 24h SBP as lin. covariates; treatment, bl renal function, region, bl N of antihyperten. med. as fixed effects|Difference calculated as empa 25mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.||-2.83|-5.50|<0.0001
70905240|NCT01370005|141299599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|0.4||0.0008|TWO_SIDED|95.0|-2.15|-0.56||Hierarchical testing, no adjustment of p-values.|ANCOVA|Model incl. baseline (bl) HbA1c, bl mean 24h DBP as lin. covariates; treatment, bl renal function, region, bl N of antihyperten. med. as fixed effects|Difference calculated as empa 10mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.||-0.56|-2.15|0.0008
70905241|NCT01370005|141299599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-2.51|-0.93||Hierarchical testing, no adjustment of p-values.|ANCOVA|Model incl. baseline (bl) HbA1c, bl mean 24h DBP as lin. covariates; treatment, bl renal function, region, bl N of antihyperten. med. as fixed effects|Difference calculated as empa 25mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.||-0.93|-2.51|<0.0001
70905242|NCT01370005|141299600|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.26|||<|0.0001|TWO_SIDED|95.0|3.51|11.18|||Regression, Logistic|Logistic regression model includes treatment, baseline renal function, region, baseline number of antihypertensive medications and baseline HbA1c||||11.18|3.51|<0.0001
70905243|NCT01370005|141299600|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.59|||<|0.0001|TWO_SIDED|95.0|3.7|11.75|||Regression, Logistic|Logistic regression model includes treatment, baseline renal function, region, baseline number of antihypertensive medications and baseline HbA1c||||11.75|3.70|<0.0001
70905244|NCT01370005|141299601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.76|STANDARD_ERROR_OF_MEAN|2.63|<|0.0001|TWO_SIDED|95.0|-28.91|-18.6|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline FPG|Difference calculated as empa 10mg minus placebo.|||-18.60|-28.91|<0.0001
70905245|NCT01370005|141299601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.2|STANDARD_ERROR_OF_MEAN|2.61|<|0.0001|TWO_SIDED|95.0|-35.32|-25.08|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline FPG|Difference calculated as empa 25mg minus placebo.|||-25.08|-35.32|<0.0001
70905246|NCT01370005|141299602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.49|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.85|-1.13|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline number of antihypertensive med., baseline HbA1c and baseline weight|Difference calculated as empa 10mg minus placebo.|||-1.13|-1.85|<0.0001
70905247|NCT01370005|141299602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-2.33|-1.62|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline number of antihypertensive med., baseline HbA1c and baseline weight|Difference calculated as empa 10mg minus placebo.|||-1.62|-2.33|<0.0001
70905248|NCT01370005|141299603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.94|STANDARD_ERROR_OF_MEAN|0.73|<|0.0001|TWO_SIDED|95.0|-5.37|-2.52|||ANCOVA|Model includes treatment, baseline renal function, geographical region, N of antihypertensive medications, baseline HbA1c and baseline daytime SBP|Difference calculated as empa 10mg minus placebo.|||-2.52|-5.37|<0.0001
70905249|NCT01370005|141299603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.78|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|-6.2|-3.36|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline daytime SBP|Difference calculated as empa 25mg minus placebo.|||-3.36|-6.20|<0.0001
70905250|NCT01370005|141299604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.56|STANDARD_ERROR_OF_MEAN|0.44||0.0004|TWO_SIDED|95.0|-2.42|-0.69|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline daytime DBP|Difference calculated as empa 10mg minus placebo.|||-0.69|-2.42|0.0004
70905251|NCT01370005|141299604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|-2.84|-1.12|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline daytime DBP|Difference calculated as empa 25mg minus placebo.|||-1.12|-2.84|<0.0001
70905252|NCT01370005|141299605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|0.81||0.0021|TWO_SIDED|95.0|-4.09|-0.91|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline night-time SBP|Difference calculated as empa 10mg minus placebo.|||-0.91|-4.09|0.0021
70905253|NCT01370005|141299605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|0.81||0.0003|TWO_SIDED|95.0|-4.48|-1.32|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline night-time SBP|Difference calculated as empa 25mg minus placebo.|||-1.32|-4.48|0.0003
70905254|NCT01370005|141299606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.5||0.0566|TWO_SIDED|95.0|-1.93|0.03|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline night-time DBP|Difference calculated as empa 10mg minus placebo.|||0.03|-1.93|0.0566
70905255|NCT01370005|141299606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|0.5||0.0208|TWO_SIDED|95.0|-2.12|-0.18|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline night-time DBP|Difference calculated as empa 25mg minus placebo.|||-0.18|-2.12|0.0208
70905256|NCT01370005|141299607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.92|STANDARD_ERROR_OF_MEAN|0.99|<|0.0001|TWO_SIDED|95.0|-5.86|-1.98|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline seated SBP|Difference calculated as empa 10mg minus placebo.|||-1.98|-5.86|<0.0001
70905257|NCT01370005|141299607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|0.98|<|0.0001|TWO_SIDED|95.0|-6.73|-2.87|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline seated SBP|Difference calculated as empa 25mg minus placebo.|||-2.87|-6.73|<0.0001
70905258|NCT01370005|141299608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|0.55||0.0005|TWO_SIDED|95.0|-3.01|-0.84|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline seated DBP|Difference calculated as empa 10mg minus placebo.|||-0.84|-3.01|0.0005
70905259|NCT01370005|141299608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.89|STANDARD_ERROR_OF_MEAN|0.55||0.0006|TWO_SIDED|95.0|-2.97|-0.82|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline seated DBP|Difference calculated as empa 25mg minus placebo.|||-0.82|-2.97|0.0006
70905260|NCT01370005|141299609|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.49||||0.0021|TWO_SIDED|95.0|1.39|4.45|||Regression, Logistic|Logistic regression model includes treatment, baseline renal function, region, baseline number of antihypertensive medications and baseline HbA1c||||4.45|1.39|0.0021
70905261|NCT01370005|141299609|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.0088|TWO_SIDED|95.0|1.22|3.96|||Regression, Logistic|Logistic regression model includes treatment, baseline renal function, region, baseline number of antihypertensive medications and baseline HbA1c||||3.96|1.22|0.0088
70905262|NCT02049710|141299622|OTHER||Mean Difference (Final Values)|5.06|||||TWO_SIDED|95.0|3.0|15.0||||||Summation scores are reported across 3 items measured on a 5-point scale from 1(not at all sure)to5(very sure), which loaded together on a principal components analysis of the baseline data.The summation score thus represents a theoretical range from 3 to 15.The 3 items were as follows:Indicate How Sure You are that You Would be Able to Perform Each of the Following:a)Get the money needed to buy condoms b)Walk into a store\&buy condoms c)Find a place to get condoms for free(Cronbach alpha-0.72)||15|3|
70905263|NCT00874432|141299629|SUPERIORITY|||||||0.685|||||||t-test, 2 sided|||p-value for CBPWV between CKD and Control groups||||0.685
70905264|NCT00874432|141299629|SUPERIORITY|||||||0.739|||||||t-test, 2 sided|||p-value for CRPWV between CKD and Control groups||||0.739
70905265|NCT00874432|141299629|SUPERIORITY|||||||0.471|||||||t-test, 2 sided|||p-value for CFPWV between CKD and Control groups||||0.471
70905266|NCT00874432|141299630|SUPERIORITY|||||||0.685|||||||t-test, 2 sided|||This p-value compares the baseline CBPWV measures for the CKD vs Controls group||||0.685
70905267|NCT00874432|141299630|SUPERIORITY|||||||0.869|||||||t-test, 2 sided|||This p-value compares the 12 month CBPWV measures for the CKD vs Controls group||||0.869
70905268|NCT00874432|141299630|SUPERIORITY|||||||0.709|||||||t-test, 2 sided|||This p-value compares the baseline CRPWV measures for the CKD vs Controls group||||0.709
70905269|NCT00874432|141299630|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|||This p-value compares the 12 month CBPWV measures for the CKD vs Controls group||||0.340
70905270|NCT00874432|141299630|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||This p-value compares the baseline CFPWV measures for the CKD vs Controls group||||0.730
70905271|NCT00874432|141299630|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||This p-value compares the 12 month CFPWV measures for the CKD vs Controls group||||0.204
70905272|NCT00874432|141299630|SUPERIORITY|||||||0.963|||||||t-test, 2 sided|||This compares the 12 month CBPWV measure of ACE-I CKD and Control groups||||0.963
70905273|NCT00874432|141299630|SUPERIORITY|||||||0.991|||||||t-test, 2 sided|||This compares the 12 month CRPWV measure of ACE-I CKD and Control groups||||0.991
70905274|NCT00874432|141299630|SUPERIORITY|||||||0.176|||||||t-test, 2 sided|||This compares the 12 month CFPWV measure of ACE-I CKD and Control groups||||0.176
70905275|NCT00874432|141299630|SUPERIORITY|||||||0.402|||||||t-test, 2 sided|||This compares the baseline and 12 month CBPWV measure of the ACE-I CKD||||0.402
70905276|NCT00874432|141299630|SUPERIORITY|||||||0.586|||||||t-test, 2 sided|||This compares the baseline and 12 month CRPWV measure of the ACE-I CKD||||0.586
70905277|NCT00874432|141299630|SUPERIORITY|||||||0.455|||||||t-test, 2 sided|||This compares the baseline and 12 month CFPWV measure of the ACE-I CKD||||0.455
70905278|NCT00874432|141299630|SUPERIORITY|||||||0.418|||||||t-test, 2 sided|||This compares the baseline and 12 month CBPWV measure of the ACE-I Control Group||||0.418
70905279|NCT00874432|141299630|SUPERIORITY|||||||0.091|||||||t-test, 2 sided|||This compares the baseline and 12 month CRPWV measure of the ACE-I Control Group||||0.091
70905280|NCT00874432|141299630|SUPERIORITY|||||||0.034|||||||t-test, 2 sided|||This compares the baseline and 12 month CFPWV measure of the ACE-I Control Group||||0.034
70905281|NCT00874432|141299630|SUPERIORITY|||||||0.921|||||||t-test, 2 sided|||This compares the 12 month CBPWV measure of the CKD and Control groups||||0.921
70905282|NCT00874432|141299630|SUPERIORITY|||||||0.887|||||||t-test, 2 sided|||This compares the 12 month CRPWV measure of the CKD and Control groups||||0.887
70905283|NCT00874432|141299630|SUPERIORITY|||||||0.759|||||||t-test, 2 sided|||This compares the 12 month CFPWV measure of the CKD and Control groups||||0.759
70905284|NCT00874432|141299630|SUPERIORITY|||||||0.851|||||||t-test, 2 sided|||This compares the baseline and 12 month CBPWV measure of the Control groups||||0.851
70905285|NCT00874432|141299630|SUPERIORITY|||||||0.733|||||||t-test, 2 sided|||This compares the baseline and 12 month CRPWV measure of the Control groups||||0.733
70905286|NCT00874432|141299630|SUPERIORITY|||||||0.902|||||||t-test, 2 sided|||This compares the baseline and 12 month CFPWV measure of the Control groups||||0.902
70905287|NCT00874432|141299630|SUPERIORITY|||||||0.414|||||||t-test, 2 sided|||This compares the 12 month CBPWV measure between the CKD ACE-I and CKD Control groups.||||0.414
70905288|NCT00874432|141299630|SUPERIORITY|||||||0.942|||||||t-test, 2 sided|||This compares the 12 month CRPWV measure between the CKD ACE-I and CKD Control groups.||||0.942
70905289|NCT00874432|141299630|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||This compares the 12 month CFPWV measure between the CKD ACE-I and CKD Control groups.||||0.990
70905290|NCT00874432|141299630|SUPERIORITY|||||||0.273|||||||t-test, 2 sided|||This compares the 12 month CBPWV measure between the ACE-I Control and CKD Control groups.||||0.273
70905291|NCT00874432|141299630|SUPERIORITY|||||||0.516|||||||t-test, 2 sided|||This compares the 12 month CRPWV measure between the ACE-I Control and CKD Control groups.||||0.516
70905292|NCT00874432|141299630|SUPERIORITY|||||||0.102|||||||t-test, 2 sided|||This compares the 12 month CFPWV measure between the ACE-I Control and CKD Control groups.||||0.102
70905293|NCT00405353|141299653|OTHER||||||<|0.05|||||||Mixed Models Analysis|Linear regressions were used to determine slopes of brain volume changes. Statistical software package SAS was used to perform the analysis.||Percent change in brain volume against time scatter plot with a Loess regression curve was produced and a first-degree spline model was developed. This model fitted line pieces for pre-treatment and early treatment periods (month -6 to month 3) and treatment response period (months 3-12), and these pieces were joined together to achieve continuity. Slopes of these lines were estimated and compared. A random intercept was set in the model to allow the difference among subjects.||||<0.05
70905294|NCT01158378|141299654|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin of 10%||||||0.0049|||||||one-sided z-test|||||||0.0049
70905295|NCT01158378|141299655|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin of 10%|||||<|0.0001|||||||one-sided z-test|||||||<0.0001
70905296|NCT01158378|141299655|SUPERIORITY_OR_OTHER|||||||0.0297|||||||one-sided z-test|||Superiority Test||||0.0297
70905297|NCT01158378|141299656|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin of 10%|||||<|0.0001|||||||one-sided z-test|||||||<0.0001
70905298|NCT01158378|141299656|SUPERIORITY_OR_OTHER|||||||0.0561|||||||one-sided z-test|||Superiority Test||||0.0561
70905299|NCT00437125|141299681|SUPERIORITY_OR_OTHER||Percentage|8.6|||||ONE_SIDED|95.0||13.3||||||||13.3||
70905300|NCT00437125|141299682|SUPERIORITY_OR_OTHER|||||||0.5553||95.0||||p-value is for total UDPRS score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the total UDPRS score from baseline to 12-week endpoint.||||0.5553
70905301|NCT00437125|141299683|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for psychic subscale. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the total psychic subscale score from baseline to 12-week endpoint.||||<0.0001
70905302|NCT00437125|141299683|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for neurological subscale. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the total neurological subscale score from baseline to 12-week endpoint.||||<0.0001
70905303|NCT00437125|141299683|SUPERIORITY_OR_OTHER|||||||0.0014||95.0||||p-value is for autonomic subscale. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the total autonomic subscale score from baseline to 12-week endpoint.||||0.0014
70905304|NCT00437125|141299683|SUPERIORITY_OR_OTHER|||||||0.5586||95.0||||p-value is for other subscale. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the total other subscale score from baseline to 12-week endpoint.||||0.5586
70905305|NCT00437125|141299683|SUPERIORITY_OR_OTHER|||||||0.0848||95.0||||p-value is for global assessment by paticipant. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the global assessment by paticipant subscale score from baseline to 12-week endpoint.||||0.0848
70905306|NCT00437125|141299683|SUPERIORITY_OR_OTHER|||||||0.0263||95.0||||p-value is for global assessment by doctor. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the global assessment by doctor subscale score from baseline to 12-week endpoint.||||0.0263
70905307|NCT00437125|141299684|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for 4 weeks change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the Pittsburgh Sleep Quality Index from baseline to 4-week endpoint.||||<0.0001
70905308|NCT00437125|141299684|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for 8 weeks change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the Pittsburgh Sleep Quality Index from baseline to 8-week endpoint.||||<0.0001
70905309|NCT00437125|141299684|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for 12 weeks change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the Pittsburgh Sleep Quality Index from baseline to 12-week endpoint.||||<0.0001
70905310|NCT00437125|141299685|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for the HAMD-17 total score. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the HAMD-17 total score from baseline to 12-week endpoint.||||<0.0001
70905311|NCT00437125|141299686|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for Clinical Global Impression-Severity scale - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the Clinical Global Impression-Severity scale score from baseline to end of week 12 of treatment.||||<0.0001
70905312|NCT00437125|141299688|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for BDI score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no difference between baseline and post-baseline in BDI scores||||<0.0001
70905313|NCT00437125|141299689|SUPERIORITY_OR_OTHER|||||||0.0027||95.0||||p-value is for VAS overall pain score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS overall pain scores.||||0.0027
70905314|NCT00437125|141299689|SUPERIORITY_OR_OTHER|||||||0.0002||95.0||||p-value is for VAS Headaches score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS headaches scores.||||0.0002
70905315|NCT00437125|141299689|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for VAS back ache score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS back ache scores.||||<0.0001
70905316|NCT00437125|141299689|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for VAS shoulder pain score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS shoulder pain score.||||<0.0001
70905317|NCT00437125|141299689|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for VAS interference score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS interference score.||||<0.0001
70905318|NCT00437125|141299689|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for VAS pain while awake score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS pain while awake score.||||<0.0001
70905319|NCT00437125|141299690|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for PDQ-39 total score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in PDQ-39 total score.||||<0.0001
70905320|NCT00649389|141299699|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
70905321|NCT00649389|141299699|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
70905322|NCT00649389|141299699|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
70905323|NCT00649389|141299700|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Each p-value was obtained from individual Cochran-Mantel-Haenszel tests stratified by age group, race group, and diabetic status comparing the triple combination therapy to each dual combination.||||<0.0001
70905324|NCT00649389|141299700|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Each p-value was obtained from individual Cochran-Mantel-Haenszel tests stratified by age group, race group, and diabetic status comparing the triple combination therapy to each dual combination.||||<0.0001
70905325|NCT00649389|141299700|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Each p-value was obtained from individual Cochran-Mantel-Haenszel tests stratified by age group, race group, and diabetic status comparing the triple combination therapy to each dual combination.||||<0.0001
70905326|NCT00649389|141299701|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Diastolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
70905327|NCT00649389|141299701|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Diastolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
70905328|NCT00649389|141299701|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANCOVA|||Diastolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||0.0001
70905329|NCT00649389|141299701|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Systolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
70905330|NCT00649389|141299701|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Systolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
70905331|NCT00649389|141299701|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Systolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
70905332|NCT00649389|141299702|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
70905333|NCT00649389|141299702|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
70905334|NCT00649389|141299702|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
70905335|NCT00871351|141299731|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-10.6|||<|0.0001|TWO_SIDED|95.0|-15.4|-5.8|||Hochberg's method|||||-5.8|-15.4|<0.0001
70905336|NCT00871351|141299731|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-26.5|||<|0.0001|TWO_SIDED|95.0|-31.8|-21.2|||Hochberg's method|||||-21.2|-31.8|<0.0001
70905337|NCT00871351|141299732|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0|||||Hochberg's method|||||||0.0003
70905338|NCT00871351|141299732|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Hochberg's method|||||||<0.0001
70905339|NCT02791490|141299743|SUPERIORITY||Difference in Least Squares Means|-0.41|||<|0.001|TWO_SIDED|95.0|-0.59|-0.23|||Longitudinal Data Analysis|||||-0.23|-0.59|<0.001
70905340|NCT02791490|141299744|OTHER|95% CI|Difference in % vs Placebo|-1.7|||||TWO_SIDED|95.0|-10.8|7.4|||Miettinen and Nurminen method|||||7.4|-10.8|
70905341|NCT02791490|141299746|SUPERIORITY||Relative Risk|1.7||||0.002|TWO_SIDED|95.0|1.2|2.5|||Miettinen and Nurminen method|||||2.5|1.2|0.002
70905342|NCT02791490|141299747|SUPERIORITY||Difference in Least Squares Means|-12.4||||0.002|TWO_SIDED|95.0|-20.2|-4.6|||Longitudinal Data Analysis|||||-4.6|-20.2|0.002
70967407|NCT01431274|141440929|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.084|STANDARD_ERROR_OF_MEAN|0.026||0.0011|TWO_SIDED|95.0|0.033|0.134||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.134|0.033|0.0011
70905343|NCT01984424|141299750|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-37.79|STANDARD_ERROR_OF_MEAN|2.29|<|0.0001|TWO_SIDED|95.0|-42.31|-33.28|||Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from baseline at week 24 of part B or in the mean percent change from baseline at weeks 22 and 24 of part B in LDL-C between evolocumab 420 mg and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-33.28|-42.31|<0.0001
70905344|NCT01984424|141299751|SUPERIORITY||LS Mean Treatment Difference|-36.07|STANDARD_ERROR_OF_MEAN|2.53|<|0.0001|TWO_SIDED|95.0|-41.07|-31.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from baseline at week 24 of part B or in the mean percent change from baseline at weeks 22 and 24 of part B in LDL-C between evolocumab 420 mg and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-31.08|-41.07|<0.0001
70905345|NCT01984424|141299752|SUPERIORITY||LS Mean Treatment Difference|-75.8|STANDARD_ERROR_OF_MEAN|4.5|<|0.0001|TWO_SIDED|95.0|-84.7|-67.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-67.0|-84.7|<0.0001
70905346|NCT01984424|141299753|SUPERIORITY||LS Mean Treatment Difference|-71.7|STANDARD_ERROR_OF_MEAN|4.8|<|0.0001|TWO_SIDED|95.0|-81.3|-62.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-62.2|-81.3|<0.0001
70905347|NCT01984424|141299754|SUPERIORITY||Treatment Difference|28.5|||<|0.0001|TWO_SIDED|95.0|19.1|36.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (screening LDL-C).||||36.7|19.1|<0.0001
70905348|NCT01984424|141299755|SUPERIORITY||Treatment Difference|27.4|||<|0.0001|TWO_SIDED|95.0|17.7|36.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (screening LDL-C).||||36.1|17.7|<0.0001
70905349|NCT01984424|141299756|SUPERIORITY||LS Mean Treatment Difference|-26.61|STANDARD_ERROR_OF_MEAN|1.69|<|0.0001|TWO_SIDED|95.0|-29.95|-23.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-23.27|-29.95|<0.0001
70905350|NCT01984424|141299757|SUPERIORITY||LS Mean Treatment Difference|-25.08|STANDARD_ERROR_OF_MEAN|1.82|<|0.0001|TWO_SIDED|95.0|-28.67|-21.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-21.48|-28.67|<0.0001
70905351|NCT01984424|141299758|SUPERIORITY||LS Mean Treatment Difference|-33.06|STANDARD_ERROR_OF_MEAN|2.06|<|0.0001|TWO_SIDED|95.0|-37.12|-28.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-28.99|-37.12|<0.0001
70905352|NCT01984424|141299759|SUPERIORITY||LS Mean Treatment Difference|-31.1|STANDARD_ERROR_OF_MEAN|2.2|<|0.0001|TWO_SIDED|95.0|-35.44|-16.76||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-16.76|-35.44|<0.0001
70905353|NCT01984424|141299760|SUPERIORITY||LS Mean Treatment Difference|-33.86|STANDARD_ERROR_OF_MEAN|2.17|<|0.0001|TWO_SIDED|95.0|-38.15|-29.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-29.58|-38.15|<0.0001
70905354|NCT01984424|141299761|SUPERIORITY||LS Mean Treatment Difference|-31.75|STANDARD_ERROR_OF_MEAN|2.33|<|0.0001|TWO_SIDED|95.0|-36.35|-27.16||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-27.16|-36.35|<0.0001
70905355|NCT01984424|141299762|SUPERIORITY||LS Mean Treatment Difference|-29.91|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001|TWO_SIDED|95.0|-34.06|-25.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-25.77|-34.06|<0.0001
70905356|NCT01984424|141299763|SUPERIORITY||LS Mean Treatment Difference|-27.2|STANDARD_ERROR_OF_MEAN|2.22|<|0.0001|TWO_SIDED|95.0|-31.58|-22.82||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-22.82|-31.58|<0.0001
70905357|NCT01984424|141299764|SUPERIORITY||LS Mean Treatment Difference|-34.13|STANDARD_ERROR_OF_MEAN|2.26|<|0.0001|TWO_SIDED|95.0|-38.59|-29.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-29.67|-38.59|<0.0001
70905358|NCT01984424|141299765|SUPERIORITY||LS Mean Treatment Difference|-31.98|STANDARD_ERROR_OF_MEAN|2.36|<|0.0001|TWO_SIDED|95.0|-36.64|-27.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-27.32|-36.64|<0.0001
70905359|NCT01984424|141299766|SUPERIORITY||LS Mean Treatment Difference|-21.08|STANDARD_ERROR_OF_MEAN|3.33|<|0.0001|TWO_SIDED|95.0|-27.65|-14.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-14.51|-27.65|<0.0001
70905360|NCT01984424|141299767|SUPERIORITY||LS Mean Treatment Difference|-21.24|STANDARD_ERROR_OF_MEAN|3.64|<|0.0001|TWO_SIDED|95.0|-28.42|-14.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-14.05|-28.42|<0.0001
70905361|NCT01984424|141299768|SUPERIORITY||LS Mean Treatment Difference|-4.44|STANDARD_ERROR_OF_MEAN|4.72||0.37|TWO_SIDED|95.0|-13.74|4.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||4.87|-13.74|0.37
70905362|NCT01984424|141299769|SUPERIORITY||LS Mean Treatment Difference|-1.82|STANDARD_ERROR_OF_MEAN|6.0||0.37|TWO_SIDED|95.0|-13.64|10.01||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||10.01|-13.64|0.37
70905363|NCT01984424|141299770|SUPERIORITY||LS Mean Treatment Difference|6.18|STANDARD_ERROR_OF_MEAN|2.05||0.0083|TWO_SIDED|95.0|2.15|10.22||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||10.22|2.15|0.0083
70905364|NCT01984424|141299771|SUPERIORITY||LS Mean Treatment Difference|4.5|STANDARD_ERROR_OF_MEAN|2.27||0.0083|TWO_SIDED|95.0|0.02|8.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||8.98|0.02|0.0083
70905365|NCT01984424|141299772|SUPERIORITY||LS Mean Treatment Difference|-4.65|STANDARD_ERROR_OF_MEAN|3.85||0.37|TWO_SIDED|95.0|-12.25|2.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||2.94|-12.25|0.37
70905366|NCT01984424|141299773|SUPERIORITY||LS Mean Treatment Difference|-1.23|STANDARD_ERROR_OF_MEAN|4.67||0.37|TWO_SIDED|95.0|-10.45|7.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||7.98|-10.45|0.37
70905367|NCT00077636|141299774|NON_INFERIORITY_OR_EQUIVALENCE|These results indicated that sustained virological response achieved with 16 weeks of treatment was not equivalent to that achieved with 24 week of treatment.|Odds Ratio (OR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.46|0.76|||Cochran-Mantel-Haenszel|stratified by country and HCV genotype.||||0.76|0.46|<.0001
70905368|NCT00077636|141299775|NON_INFERIORITY_OR_EQUIVALENCE|In the analysis based on the standard population, end of treatment virological response was equivalent in the two treatment arms (94% in the 16-week arm and 92% in the 24-week arm).|Odds Ratio (OR)|1.32||||0.1941|TWO_SIDED|95.0|0.86|2.03|||Cochran-Mantel-Haenszel|stratified by country.||||2.03|0.86|0.1941
70905369|NCT00077636|141299776|NON_INFERIORITY_OR_EQUIVALENCE|These results indicated that sustained virological response achieved with 16 weeks of treatment was not equivalent to that achieved with 24 week of treatment.|Odds Ratio (OR)|0.65||||0.0003|TWO_SIDED|95.0|0.52|0.82|||Cochran-Mantel-Haenszel|stratified by country and HCV genotype.||||0.82|0.52|0.0003
70905370|NCT03661996|141299798|NON_INFERIORITY|The treatment regimen is Clinically Acceptable if it is no more than 30% worse than the Breg Cooling Control Group and the lower bound of the 95% CI for Ratio of Geometric LS Means is greater than 0.7.|Ratio of Geometric LS Means|1.063|STANDARD_ERROR_OF_MEAN|1.0216|||TWO_SIDED|95.0|1.019|1.108|||||Parameter dispersion is the Standard Error of the Ratio of Geometric LS Means|Geometric LS means, ratio of geometric LS means, with Breg Cooling as control, and 95% CIs were obtained from an ANCOVA model on the natural log-transformed composite outcome with cooling and injection procedure as the main effect. Baseline K-L grade, baseline BMI category, sex, and reverse-scored and normalized index knee procedure pain were included as covariates. Estimates and CIs on the log scale were exponentiated to obtain ratios of geometric means on the original scale.||1.108|1.019|
70905371|NCT03661996|141299798|NON_INFERIORITY|The treatment regimen is Clinically Acceptable if it is no more than 30% worse than the Breg Cooling Control Group and the lower bound of the 95% CI for Ratio of Geometric LS Means is greater than 0.7.|Ratio of Geometric LS Means|0.959|STANDARD_ERROR_OF_MEAN|1.0221|||TWO_SIDED|95.0|0.919|1.001|||||Parameter dispersion is the Standard Error of the Ratio of Geometric LS Means|Geometric LS means, ratio of geometric LS means, with Breg Cooling as control, and 95% CIs were obtained from an ANCOVA model on the natural log-transformed composite outcome with cooling and injection procedure as the main effect. Baseline K-L grade, baseline BMI category, sex, and reverse-scored and normalized index knee procedure pain were included as covariates. Estimates and CIs on the log scale were exponentiated to obtain ratios of geometric means on the original scale.||1.001|0.919|
70905372|NCT03661996|141299798|NON_INFERIORITY|The treatment regimen is Clinically Acceptable if it is no more than 30% worse than the Breg Cooling Control Group and the lower bound of the 95% CI for Ratio of Geometric LS Means is greater than 0.7.|Ratio of Geometric LS Means|1.013|STANDARD_ERROR_OF_MEAN|1.0219|||TWO_SIDED|95.0|0.97|1.057|||||Parameter dispersion is the Standard Error of the Ratio of Geometric LS Means|Geometric LS means, ratio of geometric LS means, with Breg Cooling as control, and 95% CIs were obtained from an ANCOVA model on the natural log-transformed composite outcome with cooling and injection procedure as the main effect. Baseline K-L grade, baseline BMI category, sex, and reverse-scored and normalized index knee procedure pain were included as covariates. Estimates and CIs on the log scale were exponentiated to obtain ratios of geometric means on the original scale.||1.057|0.970|
70905373|NCT03661996|141299798|NON_INFERIORITY|The treatment regimen is Clinically Acceptable if it is no more than 30% worse than the Breg Cooling Control Group and the lower bound of the 95% CI for Ratio of Geometric LS Means is greater than 0.7.|Ratio of Geometric LS Means|0.931|STANDARD_ERROR_OF_MEAN|1.0219|||TWO_SIDED|95.0|0.892|0.972|||||Parameter dispersion is the Standard Error of the Ratio of Geometric LS Means|Geometric LS means, ratio of geometric LS means, with Breg Cooling as control, and 95% CIs were obtained from an ANCOVA model on the natural log-transformed composite outcome with cooling and injection procedure as the main effect. Baseline K-L grade, baseline BMI category, sex, and reverse-scored and normalized index knee procedure pain were included as covariates. Estimates and CIs on the log scale were exponentiated to obtain ratios of geometric means on the original scale.||0.972|0.892|
70905374|NCT03661996|141299799|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|17.15|STANDARD_ERROR_OF_MEAN|1.396|<|0.0001|TWO_SIDED|95.0|14.4|19.9|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||19.90|14.40|<0.0001
70905375|NCT03661996|141299799|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Mean Difference (Final Values)|20.41|STANDARD_ERROR_OF_MEAN|3.692|<|0.0001|TWO_SIDED|95.0|12.79|28.03|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||28.03|12.79|<0.0001
70905376|NCT03661996|141299799|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|20.05|STANDARD_ERROR_OF_MEAN|0.819|<|0.0001|TWO_SIDED|95.0|18.44|21.66|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||21.66|18.44|<0.0001
70905377|NCT03661996|141299799|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|18.4|STANDARD_ERROR_OF_MEAN|1.011|<|0.0001|TWO_SIDED|95.0|16.41|20.38|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||20.38|16.41|<0.0001
70905378|NCT03661996|141299800|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|22.45|STANDARD_ERROR_OF_MEAN|1.478|<|0.0001|TWO_SIDED|95.0|19.54|25.37|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||25.37|19.54|<0.0001
70905379|NCT03661996|141299800|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|23.9|STANDARD_ERROR_OF_MEAN|4.613|<|0.0001|TWO_SIDED|95.0|14.38|33.42|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||33.42|14.38|<0.0001
70905380|NCT03661996|141299800|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.62|STANDARD_ERROR_OF_MEAN|0.865|<|0.0001|TWO_SIDED|95.0|23.92|27.32|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||27.32|23.92|<0.0001
70905381|NCT03661996|141299800|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|22.1|STANDARD_ERROR_OF_MEAN|1.053|<|0.0001|TWO_SIDED|95.0|20.03|24.17|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||24.17|20.03|<0.0001
70905382|NCT03661996|141299801|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|21.1|STANDARD_ERROR_OF_MEAN|1.74|<|0.0001|TWO_SIDED|95.0|17.6|24.5|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms for pooled site group, baseline K-L grade category, baseline BMI category (\<30 kg/m2, ≥30 kg/m2), sex, study visit, and baseline KOOS subscale score as covariates. Study visit was included in the model as a categorical variable.||24.5|17.6|<0.0001
70905383|NCT03661996|141299801|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.3|STANDARD_ERROR_OF_MEAN|6.06||0.0003|TWO_SIDED|95.0|12.7|37.8|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms for pooled site group, baseline K-L grade category, baseline BMI category (\<30 kg/m2, ≥30 kg/m2), sex, study visit, and baseline KOOS subscale score as covariates. Study visit was included in the model as a categorical variable.||37.8|12.7|0.0003
70905384|NCT03661996|141299801|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.85|STANDARD_ERROR_OF_MEAN|1.035|<|0.0001|TWO_SIDED|95.0|23.82|27.88|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms for pooled site group, baseline K-L grade category, baseline BMI category (\<30 kg/m2, ≥30 kg/m2), sex, study visit, and baseline KOOS subscale score as covariates. Study visit was included in the model as a categorical variable.||27.88|23.82|<0.0001
70905385|NCT03661996|141299801|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|23.34|STANDARD_ERROR_OF_MEAN|1.238|<|0.0001|TWO_SIDED|95.0|20.91|25.78|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms for pooled site group, baseline K-L grade category, baseline BMI category (\<30 kg/m2, ≥30 kg/m2), sex, study visit, and baseline KOOS subscale score as covariates. Study visit was included in the model as a categorical variable.||25.78|20.91|<0.0001
70905386|NCT03661996|141299802|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|20.86|STANDARD_ERROR_OF_MEAN|1.481|<|0.0001|TWO_SIDED|95.0|17.94|23.78|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||23.78|17.94|<0.0001
70905387|NCT03661996|141299802|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.66|STANDARD_ERROR_OF_MEAN|4.568|<|0.0001|TWO_SIDED|95.0|16.24|35.09|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||35.09|16.24|<0.0001
70905388|NCT03661996|141299802|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.57|STANDARD_ERROR_OF_MEAN|0.861|<|0.0001|TWO_SIDED|95.0|23.88|27.26|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||27.26|23.88|<0.0001
70905389|NCT03661996|141299802|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.69|STANDARD_ERROR_OF_MEAN|0.853|<|0.0001|TWO_SIDED|95.0|24.02|27.37|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||27.37|24.02|<0.0001
70905390|NCT03661996|141299803|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.17|STANDARD_ERROR_OF_MEAN|2.248|<|0.0001|TWO_SIDED|95.0|20.74|29.6|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||29.60|20.74|<0.0001
70905391|NCT03661996|141299803|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|33.11|STANDARD_ERROR_OF_MEAN|5.795|<|0.0001|TWO_SIDED|95.0|21.15|45.07|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||45.07|21.15|<0.0001
70905392|NCT03661996|141299803|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|27.8|STANDARD_ERROR_OF_MEAN|1.233|<|0.0001|TWO_SIDED|95.0|25.38|30.23|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||30.23|25.38|<0.0001
70905393|NCT03661996|141299803|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|24.8|STANDARD_ERROR_OF_MEAN|1.598|<|0.0001|TWO_SIDED|95.0|21.66|27.94|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||27.94|21.66|<0.0001
70905394|NCT03661996|141299804|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|22.1|STANDARD_ERROR_OF_MEAN|1.898|<|0.0001|TWO_SIDED|95.0|18.37|25.84|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||25.84|18.37|<0.0001
70905395|NCT03661996|141299804|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|16.75|STANDARD_ERROR_OF_MEAN|6.255|<|0.0001|TWO_SIDED|95.0|3.84|29.66|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||29.66|3.84|<0.0001
70905396|NCT03661996|141299804|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|21.52|STANDARD_ERROR_OF_MEAN|1.062|<|0.0001|TWO_SIDED|95.0|19.43|23.6|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||23.60|19.43|<0.0001
70905397|NCT03661996|141299804|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|19.4|STANDARD_ERROR_OF_MEAN|1.365|<|0.0001|TWO_SIDED|95.0|16.72|22.09|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||22.09|16.72|<0.0001
70905398|NCT03661996|141299805|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|-3.48|STANDARD_ERROR_OF_MEAN|0.191|<|0.0001|TWO_SIDED|95.0|-3.86|-3.1|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The NPRS was collected during the last study visit. Lower scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline pain score as covariates.||-3.10|-3.86|<0.0001
70905399|NCT03661996|141299805|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|-3.52|STANDARD_ERROR_OF_MEAN|0.416|<|0.0001|TWO_SIDED|95.0|-4.38|-2.67|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The NPRS was collected during the last study visit. Lower scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline pain score as covariates.||-2.67|-4.38|<0.0001
70905400|NCT03661996|141299805|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|-4.02|STANDARD_ERROR_OF_MEAN|0.118|<|0.0001|TWO_SIDED|95.0|-4.25|-3.79|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The NPRS was collected during the last study visit. Lower scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline pain score as covariates.||-3.79|-4.25|<0.0001
70905401|NCT03661996|141299805|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|-3.72|STANDARD_ERROR_OF_MEAN|0.122|<|0.0001|TWO_SIDED|95.0|-3.96|-3.48|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The NPRS was collected during the last study visit. Lower scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline pain score as covariates.||-3.48|-3.96|<0.0001
70905402|NCT01993017|141299806|SUPERIORITY|||||||0.98||||||A 2-step gatekeeping test procedure was used. An omnibus F test using ANOVA comparing the 3 groups was first performed. Pairwise comparisons using a 2-sided t test at 5% nominal significance were planned only if the omnibus F test had a P value \<.05.|ANOVA|||We determined that a sample size per group of 500, assuming 5% loss to follow-up, would yield 80% power for a 2-sided t test at the 5% level. These calculations were based on an assumed SD for QALYs of 0.17, expected prevalence of screening-detected depression of 20%, and assumed net improvement in QALYs of 0.155 over 18 months for individuals with depression who received treatment for depression in the Screen, Notify, and Treat group.||||0.98
70905403|NCT00917267|141299826|NON_INFERIORITY_OR_EQUIVALENCE|Superiority of exenatide once weekly to exenatide twice daily concluded if upper limit of the 2-sided 95% confidence interval for treatment difference is \<0; noninferiority concluded if upper limit is \<0.4%.|Least Squares Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.49|-0.14|||Mixed Models Analysis|||MMRM analysis of covariance (ANCOVA) model includes treatment, baseline HbA1c, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects. Power: 306 patients per treatment group provides approximately 98% power to detect a true difference between treatments of 0.4% in change in HbA1c from baseline with a 2-sided t test at a significance level of 0.05, assuming a common standard deviation of 1.2%.||-0.14|-0.49|<.001
70905404|NCT00917267|141299827|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Percentage of patients achieving HbA1c target \<=7% at Week 26 were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which country and background OAD served as the stratification factors.||||0.003
70905405|NCT00917267|141299828|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Percentage of patients achieving HbA1c target \<=6.5% at Week 26 were compared between treatments using a CMH test, in which country and background OAD served as the stratification factors.||||<.001
70905406|NCT00917267|141299829|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-16.67|STANDARD_ERROR_OF_MEAN|2.97|<|0.001|TWO_SIDED|95.0|-22.5|-10.83|||Mixed Models Analysis|||MMRM ANCOVA model includes treatment, baseline FSG, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.||-10.83|-22.50|<.001
70905407|NCT00917267|141299830|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.82|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|0.39|1.25|||Mixed Models Analysis|||MMRM ANCOVA model includes treatment, baseline BW, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.||1.25|0.39|<.001
70905408|NCT00917267|141299831|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|2.56||0.609|TWO_SIDED|95.0|-6.33|3.71|||Mixed Models Analysis|||MMRM ANCOVA model includes treatment, baseline TC, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.||3.71|-6.33|0.609
70905409|NCT00917267|141299832|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.52||0.476|TWO_SIDED|95.0|-0.65|1.38|||Mixed Models Analysis|||MMRM ANCOVA model includes treatment, baseline HDL, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.||1.38|-0.65|0.476
70905410|NCT00917267|141299833|SUPERIORITY_OR_OTHER||Geometic Least Squares Mean Ratio|0.99|STANDARD_ERROR_OF_MEAN|0.03||0.807|TWO_SIDED|95.0|0.93|1.06|||Mixed Models Analysis|||TG data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using a MMRM ANCOVA model with treatment, baseline TG, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.||1.06|0.93|0.807
70905411|NCT02960763|141299836|SUPERIORITY|Repeated measure of 2\*2\*3 ANOVA with age (60 - 70, \> 70), time (baseline, end of Active phase of Step 1) by treatment group (3 levels). Tests were conducted with a Hochberg Step-down procedure. If the comparison with the lowest p-value \< 0.05/3 it is significant. If the second lowest p-value is also \< 0.05/2 then it also will be significant and if the third p-value is \< 0.05 then it also will be significant.||||||0.01||||||Equivalence of group|ANOVA|||||||0.010
70905412|NCT02960763|141299836|SUPERIORITY|Repeated measure of 2\*2\*3 ANOVA with age (60 - 70, \> 70), time (baseline, end of Active phase of Step 1) by treatment group (3 levels). Tests were conducted with a Hochberg Step-down procedure. If the comparison with the lowest p-value \< 0.05/3 it is significant. If the second lowest p-value is also \< 0.05/2 then it also will be significant and if the third p-value is \< 0.05 then it also will be significant.||||||0.004||||||augment with aripiprazole vs switch to bupropion|ANOVA|||||||0.004
70905413|NCT02960763|141299836|SUPERIORITY|Repeated measure of 2\*2\*3 ANOVA with age (60 - 70, \> 70), time (baseline, end of Active phase of Step 1) by treatment group (3 levels). Tests were conducted with a Hochberg Step-down procedure. If the comparison with the lowest p-value \< 0.05/3 it is significant. If the second lowest p-value is also \< 0.05/2 then it also will be significant and if the third p-value is \< 0.05 then it also will be significant.||||||0.017||||||augment with bupropion vs switch to bupropion|ANOVA|||||||0.017
70905414|NCT02960763|141299836|SUPERIORITY|||||||0.65|||||||ANOVA|||Repeated measure of 2\*2\*3 ANOVA with age (60 - 70, \> 70), time (baseline, end of Active phase of Step 1) by treatment group (3 levels). Tests were conducted with a Hochberg Step-down procedure. If the comparison with the lowest p-value \< 0.05/3 it is significant. If the second lowest p-value is also \< 0.05/2 then it also will be significant and if the third p-value is \< 0.05 then it also will be significant.||||0.650
70905415|NCT02960763|141299836|SUPERIORITY|||||||0.003||||||augmentation versus switch|ANOVA|||Repeated measure of 2\*2\*3 ANOVA with age (60 - 70, \> 70), time (baseline, end of Active phase of Step 1) by treatment group (3 levels). Tests were conducted with a Hochberg Step-down procedure. If the comparison with the lowest p-value \< 0.05/3 it is significant. If the second lowest p-value is also \< 0.05/2 then it also will be significant and if the third p-value is \< 0.05 then it also will be significant.||||0.003
70905416|NCT02960763|141299836|SUPERIORITY|For those who proceed to Step 2, analogous repeated measures 2\*2\*2 ANOVA will be used with a significance level of .05 for the time\*treatment group comparison.||||||0.385|||||||ANOVA|||||||0.385
70905417|NCT02960763|141299837|SUPERIORITY|||||||0.038||||||Group effect|generalized linear model with logistic l|||||||0.038
70905418|NCT02960763|141299837|SUPERIORITY|||||||0.021||||||augmentation with aripiprazole vs switch to bupropion|generalized linear model with logistic l|||||||0.021
70905419|NCT02960763|141299837|SUPERIORITY|||||||0.027||||||augmentation with bupropion vs switch to bupropion|generalized linear model with logistic l|||||||0.027
70905420|NCT02960763|141299837|SUPERIORITY|||||||0.934||||||Augmentation with aripiprazole v augmentation with bupropion|generalized linear model with logistic l|||||||0.934
70905421|NCT02960763|141299837|SUPERIORITY|||||||0.011||||||augmentation versus switch|generalized linear model with logistic l|||||||0.011
70905422|NCT02960763|141299837|SUPERIORITY|||||||0.5|||||||generalized linear model with logistic l|||||||0.500
70905423|NCT02960763|141299838|SUPERIORITY|||||||0.164||||||Cox models time to event comparing treatment arms.|Regression, Cox|||||||0.164
70905424|NCT02960763|141299838|SUPERIORITY|||||||0.103|||||||Regression, Cox|||||||0.103
70905425|NCT02960763|141299838|SUPERIORITY|||||||0.127|||||||Regression, Cox|||||||0.127
70905426|NCT02960763|141299838|SUPERIORITY|||||||0.524||||||Cox models to examine time to event comparing treatment arms.|Regression, Cox|||||||0.524
70905427|NCT00312858|141299852|NON_INFERIORITY_OR_EQUIVALENCE|Similarity (non-inferiority) based on lower bound of the 2-sided 95% CI on the risk difference of seroresponse rates excluding a decrease of 10 percentage points or more (lower bound \>-10.0).|Risk Difference (RD)|0.7|||<|0.001||95.0|-1.4|3.8||Similarity (non-inferiority) indicated that the risk difference was statistically significantly greater than the pre-specified clinically relevant difference of -10 percentage points at the 1-sided α=0.025 level.|Miettinen and Nurminen|For testing the non-inferiority of 2 proportions. Stratified by investigator.|Difference in estimated response rates of Arm 1 - Arm 2.|Comparison of the difference (percentage points) in estimated response rates of Arm 1 - Arm 2.||3.8|-1.4|<0.001
70905428|NCT00312858|141299853|NON_INFERIORITY_OR_EQUIVALENCE|Similarity (non-inferiority) based on lower bound of the 2-sided 95% CI on the risk difference seroresponse rates excluding a decrease of 10 percentage points or more (lower bound \>-10.0).|Risk Difference (RD)|-5.1||||0.013||95.0|-9.3|-1.4||Similarity (non-inferiority) indicated that the risk difference was statistically significantly greater than the pre-specified clinically relevant difference of -10 percentage points at the 1-sided multiplicity-adjusted α=0.025 level.|Miettinen and Nurminen|For testing the non-inferiority of 2 proportions. Stratified by investigator.|Difference in estimated response rates of Arm 1 - Arm 2.|Comparison of the difference (percentage points) in estimated response rates of Arm 1 - Arm 2 for participants with initial serostatus \<1.25 gpELISA units/mL||-1.4|-9.3|0.013
70905429|NCT00312858|141299854|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.1|||<|0.001|TWO_SIDED|95.0|0.9|1.3|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 4||1.3|0.9|<0.001
70905430|NCT00312858|141299854|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.0|||<|0.001|TWO_SIDED|95.0|0.8|1.2|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 6B||1.2|0.8|<0.001
70905431|NCT00312858|141299854|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|0.9|||<|0.001|TWO_SIDED|95.0|0.8|1.0|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 9V||1.0|0.8|<0.001
70905432|NCT00312858|141299854|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.0|||<|0.001|TWO_SIDED|95.0|0.9|1.2|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 14||1.2|0.9|<0.001
70905433|NCT00312858|141299854|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.1|||<|0.001|TWO_SIDED|95.0|0.9|1.3|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 18C||1.3|0.9|<0.001
70905434|NCT00312858|141299854|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.1|||<|0.001|TWO_SIDED|95.0|0.9|1.2|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 19F||1.2|0.9|<0.001
70905435|NCT00312858|141299854|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.1|||<|0.001|TWO_SIDED|95.0|1.0|1.3|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 23F||1.3|1.0|<0.001
70905436|NCT00423293|141299892|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|95.0||||One-sided p-value comparing to a rate of 78% (the historical rate was updated after the study design).|Chi-squared|||The RT+ 5-FU + Mitomycin-C arm on previous Radiation Therapy Oncology Group (RTOG) study 9811 \[NCT00003596\] had a 77% rate of \>= grade 2 GI and GU adverse events. The null hypothesis for this study design was a 15% reduction for that rate. Fifty-four evaluable patients provides 80% power to detect a 15% reduction, using a one-sided chi-squared test with a type I error rate of 0.05. (With 52 patients, the power is reduced to 78%.)||||0.50
70905437|NCT00423293|141299894|SUPERIORITY|||||||0.5|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with GI grade 2+ adverse events were compared to the historical rate of 73%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.||||0.5
70905438|NCT00423293|141299894|SUPERIORITY|||||||0.18|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with GU grade 2+ adverse events were compared to the historical rate of 20%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.||||0.18
70905439|NCT00423293|141299894|SUPERIORITY|||||||0.032|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with hematologic grade 2+ adverse events were compared to the historical rate of 85%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.||||0.032
70905440|NCT00423293|141299894|SUPERIORITY|||||||0.1|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with skin grade 2+ adverse events were compared to the historical rate of 83%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.||||0.10
70905441|NCT00423293|141299894|SUPERIORITY|||||||0.12|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with any grade 2+ adverse events were compared to the historical rate of 98%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.||||0.12
70905442|NCT00423293|141299894|SUPERIORITY|||||||0.23|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with any grade 3+ adverse events were compared to the historical rate of 87%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.||||0.23
70905443|NCT01863043|141299972|SUPERIORITY|||||||0.27|||||||Mixed Models Analysis|||||||0.27
70905444|NCT01863043|141299973|SUPERIORITY|||||||0.12|||||||Mixed Models Analysis|||||||0.12
70905445|NCT01863043|141299974|SUPERIORITY|||||||0.28|||||||Mixed Models Analysis|||||||0.28
70905446|NCT01863043|141299975|SUPERIORITY|||||||0.15|||||||Mixed Models Analysis|||||||0.15
70905447|NCT01863043|141299976|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
70905448|NCT01863043|141299977|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
70905449|NCT01863043|141299978|SUPERIORITY|||||||0.59|||||||Accelerated failure time regression mode|||||||0.59
70905450|NCT01863043|141299979|SUPERIORITY|||||||0.64|||||||Accelerated failure time regression mode|||||||0.64
70905451|NCT01863043|141299980|SUPERIORITY|||||||0.95|||||||Accelerated failure time regression mode|||||||0.95
70905452|NCT01863043|141299981|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
70905453|NCT01863043|141299982|SUPERIORITY|||||||0.23|||||||Accelerated failure time regression mode|||||||0.23
70905454|NCT01863043|141299983|SUPERIORITY|||||||0.98|||||||Mixed Models Analysis|||||||0.98
70905455|NCT01863043|141299984|SUPERIORITY|||||||0.01|||||||Accelerated failure time regression mode|||||||0.01
70905456|NCT01863043|141299985|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||0.08
70905457|NCT01863043|141299986|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||0.25
70905458|NCT01863043|141299988|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
70905459|NCT01863043|141299989|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||||||0.17
70905460|NCT01863043|141299990|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||||||0.17
70905461|NCT01863043|141299991|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||||||0.43
70905462|NCT01863043|141299992|SUPERIORITY|||||||0.694|||||||Wilcoxon (Mann-Whitney)|||||||0.694
70905463|NCT01863043|141299993|SUPERIORITY|||||||0.97|||||||Accelerated failure time regression mode|||||||0.97
70905464|NCT01863043|141299994|SUPERIORITY|||||||0.6|||||||Mixed Models Analysis|||||||0.60
70905465|NCT01863043|141299995|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||0.25
70905466|NCT01863043|141299996|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
70905467|NCT01863043|141299997|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||0.002
70905468|NCT01863043|141299998|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
70905469|NCT01863043|141299999|SUPERIORITY|||||||0.56|||||||Mixed Models Analysis|||||||0.56
70905470|NCT01863043|141300000|SUPERIORITY|||||||0.59|||||||Mixed Models Analysis|||||||0.59
70905471|NCT01863043|141300001|SUPERIORITY|||||||0.888|||||||Mixed Models Analysis|||||||0.888
70905472|NCT01863043|141300002|SUPERIORITY|||||||0.694|||||||Regression, Linear|||||||0.694
70905473|NCT01863043|141300003|SUPERIORITY|||||||0.248|||||||general linear mixed model|||||||0.248
70905474|NCT01863043|141300004|SUPERIORITY|||||||0.694|||||||general linear mixed model|||||||0.694
70905475|NCT01863043|141300005|SUPERIORITY|||||||0.195|||||||Regression, Linear|||||||0.195
70905476|NCT03154359|141300018|OTHER|||||||0.197|||||||t-test, 2 sided|||Comparing 6-week responders and 6-week non-responders||||0.197
70905477|NCT03154359|141300018|OTHER|||||||0.562|||||||t-test, 2 sided|||Comparing 18-week responders and 18-week non-responders||||0.562
70905478|NCT03154359|141300019|OTHER|||||||0.558|||||||t-test, 2 sided|||||||0.558
70905479|NCT03154359|141300020|OTHER|||||||0.147|||||||t-test, 2 sided|||||||0.147
70905480|NCT03154359|141300021|OTHER|||||||0.495|||||||t-test, 2 sided|||Comparing 6-week responders and 6-week non-responders||||0.495
70905481|NCT03154359|141300021|OTHER|||||||0.955|||||||t-test, 2 sided|||Comparing 18-week responders and 18-week non-responders||||0.955
70905482|NCT03154359|141300022|OTHER|||||||0.991|||||||t-test, 2 sided|||||||0.991
70905483|NCT03154359|141300023|OTHER|||||||0.759|||||||t-test, 2 sided|||||||0.759
70905484|NCT03154359|141300024|OTHER|||||||0.456|||||||t-test, 2 sided|||Comparing 6-week responders and 6-week non-responders||||0.456
70905485|NCT03154359|141300024|OTHER|||||||0.822|||||||t-test, 2 sided|||Comparing 18-week responders and 18-week non-responders||||0.822
70905486|NCT03154359|141300025|OTHER|||||||0.343|||||||t-test, 2 sided|||||||0.343
70905487|NCT03154359|141300026|OTHER|||||||0.539|||||||t-test, 2 sided|||||||0.539
70905488|NCT03154359|141300027|OTHER|||||||0.13|||||||t-test, 2 sided|||||||0.130
70905489|NCT03154359|141300028|OTHER|||||||0.652|||||||t-test, 2 sided|||||||0.652
70905490|NCT00345384|141300042|SUPERIORITY_OR_OTHER||Precentage Difference|41.0||||0.03|TWO_SIDED|95.0|||||t-test, 2 sided||The percentage in opioid use by the dexmedetomidine group in comparison to the placebo for the period of time on study drug is calculated as follows: numerator = 29, denominator = 49.|||||0.03
70905491|NCT00345384|141300042|SUPERIORITY_OR_OTHER||Percentage difference|35.0||||0.04|TWO_SIDED|95.0|||||t-test, 2 sided||A measure of opioid use, weighted for total time on study drug. This is examined by a comparison of the dexmedetomidine group to the placebo group: numerator = 35, denominator = 54.|||||0.04
70905492|NCT00345384|141300043|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||The p-value reported in this table corresponds with the 6 to 16 hour time frame.||||0.02
70905493|NCT02223065|141300052|NON_INFERIORITY_OR_EQUIVALENCE|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|0.975||||0.495|TWO_SIDED|90.0|0.915|1.038|||ANOVA|||||1.038|0.915|0.4950
70905494|NCT02223065|141300053|NON_INFERIORITY_OR_EQUIVALENCE|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|0.993||||0.865|TWO_SIDED|90.0|0.932|1.06|||ANOVA|||||1.060|0.932|0.8650
70905495|NCT02223065|141300054|NON_INFERIORITY_OR_EQUIVALENCE|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|1.022||||0.2344|TWO_SIDED|90.0|0.991|1.054|||ANOVA|||||1.054|0.991|0.2344
70905496|NCT02223065|141300055|NON_INFERIORITY_OR_EQUIVALENCE|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|1.016||||0.2458|TWO_SIDED|90.0|0.993|1.038|||ANOVA|||||1.038|0.993|0.2458
70905497|NCT02223065|141300056|NON_INFERIORITY_OR_EQUIVALENCE|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|1.024||||0.1947|TWO_SIDED|90.0|0.993|1.056|||ANOVA|||||1.056|0.993|0.1947
70905498|NCT02223065|141300057|NON_INFERIORITY_OR_EQUIVALENCE|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|1.013||||0.3191|TWO_SIDED|90.0|0.992|1.034|||ANOVA|||||1.034|0.992|0.3191
70905499|NCT00152971|141300058|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 9.2% on the absolute risk difference scale|Risk Difference (Percentage)|5.8||||0.0234||95.0|0.8|10.8||Hierarchical testing procedure: first non-inferiority, second superiority|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||10.8|0.8|0.0234
70905500|NCT00152971|141300058|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 9.2% on the absolute risk difference scale|Risk Difference (Percentage)|8.4||||0.0009||95.0|3.4|13.3||Hierarchical testing procedure: first non-inferiority, second superiority|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||13.3|3.4|0.0009
70905501|NCT00152971|141300059|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|1.2||||0.2139||95.0|-0.7|3.0|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||3.0|-0.7|0.2139
70905502|NCT00152971|141300059|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.8||||0.3628||95.0|-0.9|2.5|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||2.5|-0.9|0.3628
70905503|NCT00152971|141300060|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.9||||0.2309||95.0|-0.6|2.5|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||2.5|-0.6|0.2309
70905504|NCT00152971|141300060|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|1.5||||0.0602||95.0|-0.1|3.2|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||3.2|-0.1|0.0602
70905505|NCT00152971|141300061|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|5.9||||0.0194||95.0|1.0|10.9|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||10.9|1.0|0.0194
70905506|NCT00152971|141300061|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|8.9||||0.0004||95.0|4.0|13.9|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||13.9|4.0|0.0004
70905507|NCT00152971|141300062|SUPERIORITY_OR_OTHER|||||||0.5774||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.5774
70905508|NCT00152971|141300062|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
70905509|NCT00152971|141300063|SUPERIORITY_OR_OTHER|||||||0.7724||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.7724
70905510|NCT00152971|141300063|SUPERIORITY_OR_OTHER|||||||0.0308||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.0308
70905511|NCT00152971|141300064|SUPERIORITY_OR_OTHER|||||||0.4968||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.4968
70905512|NCT00152971|141300064|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
70905513|NCT00152971|141300066|SUPERIORITY_OR_OTHER|||||||0.1416||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.1416
70905514|NCT00152971|141300066|SUPERIORITY_OR_OTHER|||||||0.0942||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.0942
70905515|NCT03292146|141300067|SUPERIORITY|||||||0.009|||||||Mixed Models Analysis|||||||0.009
70905516|NCT03292146|141300068|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
70905517|NCT03292146|141300069|SUPERIORITY|||||||0.06|||||||Matched pairs|||||||0.06
70905518|NCT03292146|141300069|SUPERIORITY|||||||0.01|||||||Matched pairs|||||||0.01
70905519|NCT00366301|141300071|SUPERIORITY_OR_OTHER||Percent Change in Log CRP|20.0|STANDARD_ERROR_OF_MEAN|10.0|<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Adjusted models included terms for baseline HbA1c and weight and change in weight at each time point.||As hsCRP was measured at both 6 and 14 weeks, linear mixed models conditioning on baseline hsCRP and adjusting for treatment stratum were constructed with the dependent variable being change in lnCRP. The means at each time point were estimated from a repeated-measures model incorporating all 3 time points. The interventions were assessed by fitting terms corresponding to study drug and treatment arm assignment.||||<0.05
70905520|NCT02354963|141300072|SUPERIORITY|||||||0.302|||||||Wilcoxon (Mann-Whitney)|||||||0.302
70905521|NCT02354963|141300073|SUPERIORITY|||||||0.449|||||||Wilcoxon (Mann-Whitney)|||||||0.449
70905522|NCT02354963|141300074|SUPERIORITY|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
70905523|NCT02354963|141300075|SUPERIORITY|||||||0.427|||||||Wilcoxon (Mann-Whitney)|||||||0.427
70905524|NCT02354963|141300076|SUPERIORITY|||||||0.496|||||||Wilcoxon (Mann-Whitney)|||||||0.496
70905525|NCT02354963|141300077|SUPERIORITY||Risk Ratio (RR)|0.71||||0.684|TWO_SIDED|95.0|0.13|3.68|||Chi-squared|||||3.68|0.13|0.684
70905526|NCT02354963|141300078|SUPERIORITY|||||||0.48|||||||Chi-squared|||||||0.480
70905527|NCT02354963|141300079|SUPERIORITY|||||||0.236|||||||Chi-squared|||||||0.236
70905528|NCT02354963|141300080|SUPERIORITY||Risk Ratio (RR)|0.71||||0.684|TWO_SIDED|95.0|0.13|3.68|||Chi-squared|||||3.68|0.13|0.684
70905529|NCT02354963|141300081|SUPERIORITY||Risk Ratio (RR)|0.36||||0.512|TWO_SIDED|95.0|0.04|3.05|||Chi-squared|||||3.05|0.04|0.512
70905530|NCT01076088|141300091|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.27||||0.087|TWO_SIDED|95.0|-0.58|0.04||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. metformin 850 mg. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline A1C.||||0.04|-0.58|0.087
70905531|NCT01076088|141300091|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.84|||<|0.001|TWO_SIDED|95.0|-1.15|-0.52||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. sitagliptin 100 mg. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.52|-1.15|<0.001
70905532|NCT01076088|141300091|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.39||||0.014|TWO_SIDED|95.0|-0.69|-0.08||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. metformin 500 mg. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.08|-0.69|0.014
70905533|NCT01076088|141300091|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.68|||<|0.001|TWO_SIDED|95.0|-0.99|-0.37||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. sitagliptin 100 mg. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.37|-0.99|<0.001
70905534|NCT01076088|141300091|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-1.24|||<|0.001|TWO_SIDED|95.0|-1.55|-0.93||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.93|-1.55|<0.001
70905535|NCT01076088|141300091|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.97|||<|0.001|TWO_SIDED|95.0|-1.28|-0.66||Pairwise comparison, metformin 850 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.66|-1.28|<0.001
70905536|NCT01076088|141300091|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-1.08|||<|0.001|TWO_SIDED|95.0|-1.39|-0.78||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.78|-1.39|<0.001
70905537|NCT01076088|141300091|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.7|||<|0.001|TWO_SIDED|95.0|-1.01|-0.39||Pairwise comparison, metformin 500 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.39|-1.01|<0.001
70905538|NCT01076088|141300091|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.4||||0.011|TWO_SIDED|95.0|-0.71|-0.09||Pairwise comparison, sitagliptin 100 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.09|-0.71|0.011
70905539|NCT01076088|141300091|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.36||||0.008|TWO_SIDED|95.0|-0.62|-0.09||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. metformin 850 mg. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.09|-0.62|0.008
70905540|NCT01076088|141300091|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.87|||<|0.001|TWO_SIDED|95.0|-1.13|-0.6||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.60|-1.13|<0.001
70905541|NCT01076088|141300091|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.36||||0.007|TWO_SIDED|95.0|-0.63|-0.1||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.10|-0.63|0.007
70905542|NCT01076088|141300091|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.61|||<|0.001|TWO_SIDED|95.0|-0.88|-0.35||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.35|-0.88|<0.001
70905543|NCT01076088|141300091|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-1.25|||<|0.001|TWO_SIDED|95.0|-1.52|-0.99||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.99|-1.52|<0.001
70905544|NCT01076088|141300091|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.9|||<|0.001|TWO_SIDED|95.0|-1.16|-0.63||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.63|-1.16|<0.001
70905545|NCT01076088|141300091|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-1.0|||<|0.001|TWO_SIDED|95.0|-1.26|-0.74||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.74|-1.26|<0.001
70905546|NCT01076088|141300091|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.64|||<|0.001|TWO_SIDED|95.0|-0.9|-0.37||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.37|-0.90|<0.001
70905547|NCT01076088|141300091|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.39||||0.004|TWO_SIDED|95.0|-0.65|-0.12||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.12|-0.65|0.004
70905548|NCT01076088|141300092|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-18.52||||0.017|TWO_SIDED|95.0|-33.75|-3.29||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. metformin 850 mg.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-3.29|-33.75|0.017
70905549|NCT01076088|141300092|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-61.34|||<|0.001|TWO_SIDED|95.0|-76.61|-46.07||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. sitagliptin 100 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-46.07|-76.61|<0.001
70905550|NCT01076088|141300092|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-31.38|||<|0.001|TWO_SIDED|95.0|-46.49|-16.28||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. metformin 500 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-16.28|-46.49|<0.001
70905551|NCT01076088|141300092|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-48.94|||<|0.001|TWO_SIDED|95.0|-64.21|-33.67||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. sitagliptin 100 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-33.67|-64.21|<0.001
70905552|NCT01076088|141300092|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-87.57|||<|0.001|TWO_SIDED|95.0|-102.87|-72.27||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. placebo|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-72.27|-102.87|<0.001
70905553|NCT01076088|141300092|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-69.05|||<|0.001|TWO_SIDED|95.0|-84.41|-53.7||Pairwise comparison, metformin 850 mg vs. placebo|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-53.70|-84.41|<0.001
70905554|NCT01076088|141300092|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-75.17|||<|0.001|TWO_SIDED|95.0|-90.47|-59.87||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. placebo|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-59.87|-90.47|<0.001
70905555|NCT01076088|141300092|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-43.79|||<|0.001|TWO_SIDED|95.0|-58.99|-28.58||Pairwise comparison, metformin 500 mg vs. placebo|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-28.58|-58.99|<0.001
70905556|NCT01076088|141300092|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-26.23|||<|0.001|TWO_SIDED|95.0|-41.62|-10.84||Pairwise comparison, sitagliptin 100 mg vs. placebo|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-10.84|-41.62|<0.001
70905557|NCT01076088|141300093|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-8.11||||0.069|TWO_SIDED|95.0|-16.86|0.64||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. metformin 850 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||0.64|-16.86|0.069
70905558|NCT01076088|141300093|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-25.88|||<|0.001|TWO_SIDED|95.0|-34.72|-17.04||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. sitagliptin 100 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-17.04|-34.72|<0.001
70905559|NCT01076088|141300093|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.72||||0.198|TWO_SIDED|95.0|-14.44|3.0||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. metformin 500 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||3.00|-14.44|0.198
70905560|NCT01076088|141300093|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-17.53|||<|0.001|TWO_SIDED|95.0|-26.33|-8.72||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. sitagliptin 100 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-8.72|-26.33|<0.001
70905561|NCT01076088|141300093|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-35.81|||<|0.001|TWO_SIDED|95.0|-44.56|-27.06||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. placebo.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-27.06|-44.56|<0.001
70905562|NCT01076088|141300093|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-27.7|||<|0.001|TWO_SIDED|95.0|-36.4|-19.0||Pairwise comparison, metformin 850 mg vs. placebo.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-19.00|-36.40|<0.001
70905563|NCT01076088|141300093|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-27.45|||<|0.001|TWO_SIDED|95.0|-36.18|-18.73||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. placebo.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-18.73|-36.18|<0.001
70905564|NCT01076088|141300093|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-21.73|||<|0.001|TWO_SIDED|95.0|-30.42|-13.04||Pairwise comparison, metformin 500 mg vs. placebo.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-13.04|-30.42|<0.001
70905565|NCT01076088|141300093|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.93||||0.027|TWO_SIDED|95.0|-18.72|-1.14||Pairwise comparison, sitagliptin 100 mg vs. placebo.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-1.14|-18.72|0.027
70905566|NCT01234649|141300171|SUPERIORITY||||||<|0.04|||||||ANOVA|||Factorial repeated measures design||||<0.04
70905567|NCT01234649|141300172|SUPERIORITY||||||<|0.005|||||||ANOVA|||Factorial repeated measures ANOVA||||<.005
70905568|NCT01234649|141300173|SUPERIORITY||||||<|0.011|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.011
70905569|NCT01234649|141300174|SUPERIORITY||||||>|0.05|||||||ANOVA|||Nested repeated measures design||||>0.05
70905570|NCT01234649|141300175|SUPERIORITY||||||<|0.03|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.03
70905571|NCT01234649|141300176|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
70905572|NCT01234649|141300177|SUPERIORITY||||||<|0.048|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.048
70905573|NCT01234649|141300178|SUPERIORITY||||||<|0.04|||||||ANOVA|||||||<0.04
70905574|NCT01234649|141300179|SUPERIORITY||||||<|0.047|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.047
70905575|NCT01234649|141300180|SUPERIORITY||||||<|0.023|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.023
70905576|NCT01234649|141300181|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
70905577|NCT01234649|141300182|SUPERIORITY|||||||0.042|||||||ANOVA|||Factorial repeated measures ANOVA||||0.042
70905578|NCT01234649|141300183|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
70905579|NCT01234649|141300184|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
70905580|NCT01234649|141300185|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
70905581|NCT01234649|141300186|SUPERIORITY||||||<|0.046|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.046
70905582|NCT01234649|141300187|SUPERIORITY||||||<|0.049|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.049
70905583|NCT01234649|141300188|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
70905584|NCT01234649|141300189|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
70905585|NCT01234649|141300190|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
70905586|NCT01234649|141300191|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
70905587|NCT01234649|141300192|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
70905588|NCT00318149|141300193|NON_INFERIORITY|Non inferiority criteria: The upper limit (UL) of the 2-sided 98.75% confidence interval (CI) on geometric mean ratio of influenza-specific T-cells (between Fluarix 18-40 Y Group and Fluarix-AS25 Group) was smaller than (\<) 2.0.|Geometric mean ratio|0.9|||||TWO_SIDED|98.75|0.7|1.16||||||Demonstration of non inferiority of the influenza adjuvanted vaccine Fluarix-AS25 administered to elderly subjects (aged 65 years and older) as compared to the licensed influenza vaccine Fluarix administered to adults (aged 18-40 years) in terms of frequency of influenza-specific CD4 T-cells producing at least 2 different cytokines (CD40L, IL-2, TNF-α or IFN-γ), 21 days post-vaccination.||1.16|0.7|
70905589|NCT00318149|141300193|NON_INFERIORITY|Non inferiority criteria: The upper limit (UL) of the 2-sided 98.75% confidence interval (CI) on geometric mean ratio of influenza-specific T-cells (between Fluarix 18-40 Y Group and Fluarix-AS50 Group) was smaller than (\<) 2.0.|Geometric mean ratio|1.05|||||TWO_SIDED|98.75|0.71|1.56||||||Demonstration of non inferiority of the influenza adjuvanted vaccine Fluarix-AS50 administered to elderly subjects (aged 65 years and older) as compared to the licensed influenza vaccine Fluarix administered to adults (aged 18-40 years) in terms of frequency of influenza-specific CD4 T-cells producing at least 2 different cytokines (CD40L, IL-2, TNF-α or IFN-γ), 21 days post-vaccination.||1.56|0.71|
70905590|NCT00318149|141300193|NON_INFERIORITY|Non inferiority criteria: The upper limit (UL) of the 2-sided 98.75% confidence interval (CI) on geometric mean ratio of influenza-specific T-cells (between Fluarix 18-40 Y Group and Fluarix-AS01B Group) was smaller than (\<) 2.0.|Geometric mean ratio|1.04|||||TWO_SIDED|98.75|0.79|1.38||||||Demonstration of non inferiority of the influenza adjuvanted vaccine Fluarix-AS01B administered to elderly subjects (aged 65 years and older) as compared to the licensed influenza vaccine Fluarix administered to adults (aged 18-40 years) in terms of frequency of influenza-specific CD4 T-cells producing at least 2 different cytokines (CD40L, IL-2, TNF-α or IFN-γ), 21 days post-vaccination.||1.38|0.79|
70905591|NCT00318149|141300193|NON_INFERIORITY|Non inferiority criteria: The upper limit (UL) of the 2-sided 98.75% confidence interval (CI) on geometric mean ratio of influenza-specific T-cells (between Fluarix 18-40 Y Group and Fluarix-AS01E Group) was smaller than (\<) 2.0.|Geometric mean ratio|1.07|||||TWO_SIDED|98.75|0.79|1.44||||||Demonstration of non inferiority of the influenza adjuvanted vaccine Fluarix-AS01E administered to elderly subjects (aged 65 years and older) as compared to the licensed influenza vaccine Fluarix administered to adults (aged 18-40 years) in terms of frequency of influenza-specific CD4 T-cells producing at least 2 different cytokines (CD40L, IL-2, TNF-α or IFN-γ), 21 days post-vaccination.||1.44|0.79|
70905592|NCT02322814|141300222|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.247||95.0|0.43|1.24|||Log Rank|||||1.24|0.43|0.2470
70905593|NCT02322814|141300224|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.5912||95.0|0.65|2.13|||Log Rank|||||2.13|0.65|0.5912
70905594|NCT02459093|141300247|SUPERIORITY||Risk Ratio (RR)|0.61||||0.04|TWO_SIDED|95.0|0.37|0.99|||Chi-squared|||||0.99|0.37|0.04
70905595|NCT02459093|141300248|SUPERIORITY||Risk Ratio (RR)|0.6||||0.05|TWO_SIDED|95.0|0.36|1.01|||Chi-squared|||||1.01|0.36|0.05
70905596|NCT01871558|141300252|SUPERIORITY_OR_OTHER|||||||0.139|||||||Chi-squared|||||||0.139
70905597|NCT01744860|141300307|SUPERIORITY_OR_OTHER||Kappa coefficient|0.8611|||||TWO_SIDED|95.0|0.8125|0.9097||||||"Kappa coefficient was used to compare the concordance between INCa Molecular Genetics Laboratory in-house methods and Cobas 4800 Mutation Test."||0.9097|0.8125|
70905598|NCT02736968|141300339|SUPERIORITY||Difference in Proportions|0.0|||>|0.999|TWO_SIDED|95.0|-0.12|0.12||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Fisher Exact||Adjusted Wald Intervals|The null hypothesis is that the probability of resolution of diarrhea by Day 5 for participants receiving auranofin is equal to that for those receiving placebo.||0.12|-0.12|>0.999
70905599|NCT02736968|141300340|SUPERIORITY||Difference in Proportions|0.0|||>|0.999|TWO_SIDED|95.0|-0.34|0.34||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Fisher Exact||Adjusted Wald Intervals|The null hypothesis is that the probability of parasitological response by Day 5 for participants receiving auranofin is equal to that for those receiving placebo.||0.34|-0.34|>0.999
70905600|NCT02736968|141300345|SUPERIORITY|||||||0.142||||||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Log Rank|||The null hypothesis is that there is no difference in time to resolution of diarrhea between treatment arms, with a two-sided alternative.||||0.142
70905601|NCT01861457|141300351|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
70905602|NCT01861457|141300352|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
70905603|NCT02041923|141300355|EQUIVALENCE|A t-test was conducted to evaluate equivalency.|Mean Difference (Net)|46.3|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
70905604|NCT04921969|141300361|SUPERIORITY||Odds Ratio (OR)|4.74||||0.0001|TWO_SIDED|95.0|1.951|13.315||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||13.315|1.951|0.0001
70905605|NCT04921969|141300361|SUPERIORITY||Odds Ratio (OR)|10.72|||<|0.0001|TWO_SIDED|95.0|4.429|30.042||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||30.042|4.429|<0.0001
70905606|NCT04921969|141300362|SUPERIORITY||Odds Ratio (OR)|1.41||||0.4198|TWO_SIDED|95.0|0.61|3.268||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||3.268|0.610|0.4198
70905607|NCT04921969|141300362|SUPERIORITY||Odds Ratio (OR)|1.8||||0.1685|TWO_SIDED|95.0|0.779|4.174||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||4.174|0.779|0.1685
70905608|NCT03518658|141300376|SUPERIORITY||Mean Difference (Final Values)|34.7|||<|0.001|TWO_SIDED|95.0|32.4|37.0||The threshold for statistical significance was 0.025.|Generalized estimating equation model|||||37.0|32.4|<0.001
70905609|NCT03518658|141300376|SUPERIORITY||Mean Difference (Final Values)|38.3|||<|0.001|TWO_SIDED|95.0|34.8|41.9||The threshold for statistical significance was 0.025.|Generalized estimating equation model|||||41.9|34.8|<0.001
70905610|NCT02105636|141300399|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0101|TWO_SIDED|95.0|0.53|0.92||Log-rank Test stratified by prior treatment with cetuximab (yes, no) as entered into the Interactive Voice Response System (IVRS). For OS the boundary for statistical significance requires the p-value to be less than 0.0227.|Log Rank||Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm.|Stratified Cox proportional hazard model. HR = Nivolumab over investigator's choice therapy (Cetuximab, Methotrexate, or Docetaxel)||0.92|0.53|0.0101
70905611|NCT02105636|141300400|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.68|1.1|||||Number of responders (CR +PR) over number of participants|||1.10|0.68|
70905612|NCT02105636|141300401|SUPERIORITY||Difference in ORR|7.6|||||TWO_SIDED|95.0|1.5|13.6|||||Stratum adjusted difference in response rates (Nivolumab - Investigators Choice) based on the Cochran-Mantel-Haenszel method of weighting.|||13.6|1.5|
70905613|NCT02105636|141300401|SUPERIORITY||CMH Estimate of Common Odds Ratio|2.49|||||TWO_SIDED|95.0|1.07|5.82|||||Stratified by Prior Cetuximab (yes, no) as recorded in the IVRS. Stratum adjusted odds ratio (Nivolumab - Investigators Choice) using Mantel-Haenszel Method.|||5.82|1.07|
70905614|NCT02105636|141300402|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.54|0.85|||||Stratified Cox proportional hazards model. Hazard ratio of nivolumab to investigator's choice therapy.|||0.85|0.54|
70905615|NCT00872430|141300432|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
70905616|NCT00872430|141300433|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||All data were collected and entered before the opening of the codes of blinding of researchers. We used t test for paired samples and test for repeated measures linear regression for variables with more than two measures.With an improvement of 40% in the tea group and of 20% in the placebo group, with a power (1-ß) of 80% and a alpha error 0.05, it was necessary to include 32 points of comparison, which would be achieved with at least 16 patients, since it's a crossover study.||||<0.001
70905617|NCT02951351|141300434|NON_INFERIORITY|By non-inferiority analysis, proparacaine was inferior to povidone iodine with a 5% margin for non-inferiority. To detect non-inferiority with one positive culture in the proparacaine group, 45 patients would be required in the proparacaine group with a 5% margin.||||||0.28|||||||Wilcoxon (Mann-Whitney)|||||||0.28
70905618|NCT02951351|141300435|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
70905619|NCT02951351|141300436|SUPERIORITY|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||||||0.86
70905620|NCT02951351|141300437|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
70905621|NCT02951351|141300438|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
70905622|NCT02951351|141300439|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
70905623|NCT02951351|141300440|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
70905624|NCT02951351|141300441|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||||||0.67
70905625|NCT01580098|141300454|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.025
70905626|NCT01580098|141300455|SUPERIORITY_OR_OTHER|||||||0.182|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Blood pressure: diastolic||||0.182
70905627|NCT00058019|141300489|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Fisher Exact|||||||0.022
70905628|NCT00058019|141300490|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
70905629|NCT00058019|141300492|SUPERIORITY_OR_OTHER|||||||0.695|TWO_SIDED|95.0|||||Log Rank|||||||0.695
70905630|NCT00058019|141300493|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED|95.0|||||Log Rank|||||||0.55
70905631|NCT01613027|141300539|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Paired t-test|||Difference in change at Month 6||||<0.001
70905632|NCT01613027|141300539|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Paired t-test|||Difference in change at Month 12||||<0.001
70905633|NCT00545363|141300556|SUPERIORITY_OR_OTHER||||||=|0.8989|||||||ANOVA|||Statistical analysis was done to compare the participant satisfaction between the Biofeedback and No-feedback arms.||||=0.8989
70905634|NCT00545363|141300557|SUPERIORITY_OR_OTHER||||||=|0.453|||||||ANOVA|||Statistical analysis was done to compare the participant perception between the Biofeedback and No-feedback arms.||||=0.453
70905635|NCT00545363|141300558|SUPERIORITY_OR_OTHER||||||=|0.4917|||||||ANOVA|||Statistical analysis was done to compare the effect of adherence (Yes/No) on percent change from baseline in CTX between the Biofeedback and No-feedback arms.||||=0.4917
70905636|NCT03125941|141300562|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.49|2.05|||Chi-squared|||||2.05|0.49|1
70905637|NCT03125941|141300563|SUPERIORITY|||||||0.114|||||||Wilcoxon (Mann-Whitney)|||||||0.114
70905638|NCT03125941|141300564|SUPERIORITY|||||||0.294|||||||Wilcoxon (Mann-Whitney)|||||||0.294
70905639|NCT03125941|141300567|SUPERIORITY|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.350
70905640|NCT03125941|141300568|SUPERIORITY|||||||0.217|||||||Wilcoxon (Mann-Whitney)|||||||0.217
70905641|NCT03125941|141300570|SUPERIORITY||||||>|0.193||||||a priori threshold, bonferroni corrected 0.0125|Wilcoxon (Mann-Whitney)|||||||>0.193
70905642|NCT03125941|141300571|SUPERIORITY||||||>|0.2|||||||Wilcoxon (Mann-Whitney)|||||||>0.2
70905643|NCT03125941|141300572|SUPERIORITY||||||>|0.136|||||||Chi-squared|||||||>0.136
70905644|NCT03125941|141300573|SUPERIORITY||||||>|0.003||||||A priori threshold for statistical significans was 0.00125 due to multiple comparisons|Chi-squared|||||||>0.003
70905645|NCT03125941|141300574|SUPERIORITY||Odds Ratio (OR)|3.53||||0.03|TWO_SIDED|95.0|1.07|11.6|||Chi-squared|||||11.6|1.07|0.030
70905646|NCT01751113|141300618|SUPERIORITY_OR_OTHER||AUC ratio|1.158|||<|0.001|TWO_SIDED|95.0|1.1|1.219|||Mixed Models Analysis|||||1.219|1.100|<0.001
70905647|NCT01751113|141300618|SUPERIORITY_OR_OTHER||AUC ratio|1.288|||<|0.001|TWO_SIDED|95.0|1.224|1.355|||Mixed Models Analysis|||||1.355|1.224|<0.001
70905648|NCT01751113|141300619|SUPERIORITY_OR_OTHER||AUC ratio|0.856|||<|0.001|TWO_SIDED|95.0|0.812|0.902|||Mixed Models Analysis|||||0.902|0.812|<0.001
70905649|NCT01751113|141300619|SUPERIORITY_OR_OTHER||AUC ratio|0.774|||<|0.001|TWO_SIDED|95.0|0.735|0.816|||Mixed Models Analysis|||||0.816|0.735|<0.001
70905650|NCT01751113|141300620|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.181|||<|0.001|TWO_SIDED|95.0|1.104|1.263|||Mixed Models Analysis||Statistical data for 30 minutes|||1.263|1.104|<0.001
70905651|NCT01751113|141300620|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.303|||<|0.001|TWO_SIDED|95.0|1.219|1.393|||Mixed Models Analysis||Statistical data for 30 minutes|||1.393|1.219|<0.001
70905652|NCT01751113|141300620|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.175|||<|0.001|TWO_SIDED|95.0|1.099|1.257|||Mixed Models Analysis||Statistical data for 75 minutes|||1.257|1.099|<0.001
70905653|NCT01751113|141300620|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.34|||<|0.001|TWO_SIDED|95.0|1.253|1.432|||Mixed Models Analysis||Statistical data for 75 minutes|||1.432|1.253|<0.001
70905654|NCT01751113|141300620|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.151|||<|0.001|TWO_SIDED|95.0|1.076|1.231|||Mixed Models Analysis||Statistical data for 120 minutes|||1.231|1.076|<0.001
70905655|NCT01751113|141300620|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.301|||<|0.001|TWO_SIDED|95.0|1.217|1.391|||Mixed Models Analysis||Statistical data for 120 minutes|||1.391|1.217|<0.001
70905656|NCT01751113|141300620|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.141|||<|0.001|TWO_SIDED|95.0|1.067|1.22|||Mixed Models Analysis||Statistical data for 240 minutes|||1.220|1.067|<0.001
70905657|NCT01751113|141300620|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.239|||<|0.001|TWO_SIDED|95.0|1.159|1.325|||Mixed Models Analysis||Statistical data for 240 minutes|||1.325|1.159|<0.001
70905658|NCT01751113|141300621|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.846|||<|0.001|TWO_SIDED|95.0|0.792|0.905|||Mixed Models Analysis||Statistical data for 30 minutes|||0.905|0.792|<0.001
70905659|NCT01751113|141300621|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.767|||<|0.001|TWO_SIDED|95.0|0.717|0.819|||Mixed Models Analysis||Statistical data for 30 minutes|||0.819|0.717|<0.001
70905660|NCT01751113|141300621|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.85|||<|0.001|TWO_SIDED|95.0|0.795|0.909|||Mixed Models Analysis||Statistical data for 75 minutes|||0.909|0.795|<0.001
70905661|NCT01751113|141300621|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.746|||<|0.001|TWO_SIDED|95.0|0.698|0.798|||Mixed Models Analysis||Statistical data for 75 minutes|||0.798|0.698|<0.001
70905662|NCT01751113|141300621|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.868|||<|0.001|TWO_SIDED|95.0|0.812|0.928|||Mixed Models Analysis||Statistical data for 120 minutes|||0.928|0.812|<0.001
70905663|NCT01751113|141300621|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.769|||<|0.001|TWO_SIDED|95.0|0.719|0.822|||Mixed Models Analysis||Statistical data for 120 minutes|||0.822|0.719|<0.001
70905664|NCT01751113|141300621|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.877|||<|0.001|TWO_SIDED|95.0|0.82|0.938|||Mixed Models Analysis||Statistical data for 240 minutes|||0.938|0.820|<0.001
70905665|NCT01751113|141300621|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.809|||<|0.001|TWO_SIDED|95.0|0.757|0.865|||Mixed Models Analysis||Statistical data for 240 minutes|||0.865|0.757|<0.001
70905666|NCT01751113|141300622|SUPERIORITY_OR_OTHER||Mean difference of FEV1|0.157|||<|0.001|TWO_SIDED|95.0|0.116|0.198|||Mixed Models Analysis||Statistical data for FEV1|||0.198|0.116|<0.001
70905667|NCT01751113|141300622|SUPERIORITY_OR_OTHER||Mean difference of FEV1|0.118|||<|0.001|TWO_SIDED|95.0|0.077|0.159|||Mixed Models Analysis||Statistical data for FEV1|||0.159|0.077|<0.001
70905668|NCT01751113|141300622|SUPERIORITY_OR_OTHER||Mean difference of FVC|0.082||||0.002|TWO_SIDED|95.0|0.031|0.133|||Mixed Models Analysis||Statistical data for FVC|||0.133|0.031|0.002
70905669|NCT01751113|141300622|SUPERIORITY_OR_OTHER||Mean difference of FVC|0.135|||<|0.001|TWO_SIDED|95.0|0.084|0.186|||Mixed Models Analysis||Statistical data for FVC|||0.186|0.084|<0.001
70905670|NCT01751113|141300622|SUPERIORITY_OR_OTHER||Mean difference of IC|0.054||||0.035|TWO_SIDED|95.0|0.004|0.104|||Mixed Models Analysis||Statistical data for IC|||0.104|0.004|0.035
70905671|NCT01751113|141300622|SUPERIORITY_OR_OTHER||Mean difference of IC|0.064||||0.011|TWO_SIDED|95.0|0.015|0.114|||Mixed Models Analysis||Statistical data for IC|||0.114|0.015|0.011
70905672|NCT01751113|141300622|SUPERIORITY_OR_OTHER||Mean difference of RV|-0.107||||0.009|TWO_SIDED|95.0|-0.187|-0.028|||Mixed Models Analysis||Statistical data for RV|||-0.028|-0.187|0.009
70905673|NCT01751113|141300622|SUPERIORITY_OR_OTHER||Mean difference of RV|-0.102||||0.012|TWO_SIDED|95.0|-0.18|-0.023|||Mixed Models Analysis||Statistical data for RV|||-0.023|-0.180|0.012
70905674|NCT01751113|141300622|SUPERIORITY_OR_OTHER||Mean difference of TLC|-0.013||||0.632|TWO_SIDED|95.0|-0.066|0.04|||Mixed Models Analysis||Statistical data for TLC|||0.040|-0.066|0.632
70905675|NCT01751113|141300622|SUPERIORITY_OR_OTHER||Mean difference of TLC|-0.014||||0.596|TWO_SIDED|95.0|-0.067|0.038|||Mixed Models Analysis||Statistical data for TLC|||0.038|-0.067|0.596
70905676|NCT01751113|141300622|SUPERIORITY_OR_OTHER||Mean difference of TGV|-0.065||||0.028|TWO_SIDED|95.0|-0.123|-0.007|||Mixed Models Analysis||Statistical data for TGV|||-0.007|-0.123|0.028
70905677|NCT01751113|141300622|SUPERIORITY_OR_OTHER||Mean difference of TGV|-0.075||||0.01|TWO_SIDED|95.0|-0.133|-0.018|||Mixed Models Analysis||Statistical data for TGV|||-0.018|-0.133|0.010
70905678|NCT01751113|141300623|SUPERIORITY_OR_OTHER||FEV1/FVC ratio|0.032|||<|0.001|TWO_SIDED|95.0|0.023|0.041|||Mixed Models Analysis||Statistical data for FEV1/FVC ratio|||0.041|0.023|<0.001
70905679|NCT01751113|141300623|SUPERIORITY_OR_OTHER||FEV1/FVC ratio|0.017|||<|0.001|TWO_SIDED|95.0|0.008|0.026|||Mixed Models Analysis||Statistical data for FEV1/FVC ratio|||0.026|0.008|<0.001
70905680|NCT01751113|141300624|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.835|||<|0.001|TWO_SIDED|95.0|0.77|0.905|||Mixed Models Analysis|||||0.905|0.770|<0.001
70905681|NCT01751113|141300624|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.803|||<|0.001|TWO_SIDED|95.0|0.741|0.869|||Mixed Models Analysis|||||0.869|0.741|<0.001
70905682|NCT01751113|141300625|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.2|||<|0.001|TWO_SIDED|95.0|1.108|1.301|||Mixed Models Analysis|||||1.301|1.108|<0.001
70905683|NCT01751113|141300625|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.249|||<|0.001|TWO_SIDED|95.0|1.153|1.352|||Mixed Models Analysis|||||1.352|1.153|<0.001
70905684|NCT01751113|141300626|SUPERIORITY_OR_OTHER||Mean difference of FEV1|0.161|||<|0.001|TWO_SIDED|95.0|0.086|0.236|||Mixed Models Analysis||Statistical data for FEV1|||0.236|0.086|<0.001
70905685|NCT01751113|141300626|SUPERIORITY_OR_OTHER||Mean difference of FEV1|0.103||||0.008|TWO_SIDED|95.0|0.028|0.178|||Mixed Models Analysis||Statistical data for FEV1|||0.178|0.028|0.008
70905686|NCT01751113|141300626|SUPERIORITY_OR_OTHER||Mean difference of FVC|0.104||||0.051|TWO_SIDED|95.0|0.0|0.209|||Mixed Models Analysis||Statistical data for FVC|||0.209|0.000|0.051
70905687|NCT01751113|141300626|SUPERIORITY_OR_OTHER||Mean difference of FVC|0.148||||0.006|TWO_SIDED|95.0|0.043|0.253|||Mixed Models Analysis||Statistical data for FVC|||0.253|0.043|0.006
70905688|NCT01751113|141300626|SUPERIORITY_OR_OTHER||Mean difference of IC|-0.008||||0.89|TWO_SIDED|95.0|-0.12|0.104|||Mixed Models Analysis||Statistical data for IC|||0.104|-0.120|0.890
70905689|NCT01751113|141300626|SUPERIORITY_OR_OTHER||Mean difference of IC|-0.008||||0.89|TWO_SIDED|95.0|-0.118|0.103|||Mixed Models Analysis||Statistical data for IC|||0.103|-0.118|0.890
70905690|NCT01751113|141300626|SUPERIORITY_OR_OTHER||Mean difference of RV|-0.229|||<|0.001|TWO_SIDED|95.0|-0.355|-0.103|||Mixed Models Analysis||Statistical data for RV|||-0.103|-0.355|<0.001
70905691|NCT01751113|141300626|SUPERIORITY_OR_OTHER||Mean difference of RV|-0.189||||0.003|TWO_SIDED|95.0|-0.314|-0.064|||Mixed Models Analysis||Statistical data for RV|||-0.064|-0.314|0.003
70905692|NCT01751113|141300626|SUPERIORITY_OR_OTHER||Mean difference of TLC|-0.101||||0.055|TWO_SIDED|95.0|-0.204|0.002|||Mixed Models Analysis||Statistical data for TLC|||0.002|-0.204|0.055
70905693|NCT01751113|141300626|SUPERIORITY_OR_OTHER||Mean difference of TLC|-0.105||||0.044|TWO_SIDED|95.0|-0.206|-0.003|||Mixed Models Analysis||Statistical data for TLC|||-0.003|-0.206|0.044
70905694|NCT01751113|141300626|SUPERIORITY_OR_OTHER||Mean difference of TGV|-0.092||||0.085|TWO_SIDED|95.0|-0.197|0.013|||Mixed Models Analysis||Statistical data for TGV|||0.013|-0.197|0.085
70905695|NCT01751113|141300626|SUPERIORITY_OR_OTHER||Mean difference of TGV|-0.091||||0.083|TWO_SIDED|95.0|-0.195|0.012|||Mixed Models Analysis||Statistical data for TGV|||0.012|-0.195|0.083
70905696|NCT01751113|141300627|SUPERIORITY_OR_OTHER||FEV1/FVC ratio|0.027|||<|0.001|TWO_SIDED|95.0|0.014|0.041|||Mixed Models Analysis||Statistical data for FEV1/FVC ratio|||0.041|0.014|<0.001
70905697|NCT01751113|141300627|SUPERIORITY_OR_OTHER||FEV1/FVC ratio|0.008||||0.223|TWO_SIDED|95.0|-0.005|0.021|||Mixed Models Analysis||Statistical data for FEV1/FVC ratio|||0.021|-0.005|0.223
70905698|NCT01003639|141300659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71||||0.05|TWO_SIDED|95.0|0.0|1.43|||ANCOVA|||||1.43|0|0.05
70905699|NCT04362137|141300664|SUPERIORITY||Odds Ratio (OR)|0.91||||0.769|TWO_SIDED|95.0|0.48|1.73|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \< 1 favors the ruxolitinib 5 mg arm|||1.73|0.48|0.769
70905700|NCT04362137|141300666|SUPERIORITY||Odds Ratio (OR)|0.89||||0.647|TWO_SIDED|95.0|0.55|1.46|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \> 1 favors the ruxolitinib 5 mg arm|Day 15||1.46|0.55|0.647
70905701|NCT04362137|141300666|SUPERIORITY||Odds Ratio (OR)|1.0||||0.997|TWO_SIDED|95.0|0.52|1.92|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \> 1 favors the ruxolitinib 5 mg arm|Day 29||1.92|0.52|0.997
70905702|NCT04362137|141300667|SUPERIORITY||Odds Ratio (OR)|0.98||||0.946|TWO_SIDED|95.0|0.51|1.87|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \> 1 favors the ruxolitinib 5 mg arm|Day 15||1.87|0.51|0.946
70905703|NCT04362137|141300667|SUPERIORITY||Odds Ratio (OR)|0.79||||0.573|TWO_SIDED|95.0|0.35|1.79|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \> 1 favors the ruxolitinib 5 mg arm|Day 29||1.79|0.35|0.573
70905704|NCT04362137|141300668|SUPERIORITY||Odds Ratio (OR)|0.75||||0.532|TWO_SIDED|95.0|0.31|1.83|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \< 1 favors the ruxolitinib 5 mg arm|Day 15||1.83|0.31|0.532
70905705|NCT04362137|141300668|SUPERIORITY||Odds Ratio (OR)|1.18||||0.764|TWO_SIDED|95.0|0.4|3.49|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \< 1 favors the ruxolitinib 5 mg arm|Day 29||3.49|0.40|0.764
70905706|NCT04362137|141300669|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.33|TWO_SIDED|95.0|0.9|1.37|||Proportional hazards model||Between group comparison using competing risk framework. A hazard ratio \> 1 favors the ruxolitinib 5 mg arm|||1.37|0.90|0.330
70905707|NCT04362137|141300670|SUPERIORITY||Least squares (LS) mean|-0.03|STANDARD_ERROR_OF_MEAN|0.144||0.831|TWO_SIDED|95.0|-0.31|0.25|||ANCOVA|||Day 15||0.25|-0.31|0.831
70905708|NCT04362137|141300670|SUPERIORITY||LS Mean|0.08|STANDARD_ERROR_OF_MEAN|0.155||0.624|TWO_SIDED|95.0|-0.23|0.38|||ANCOVA|||Day 29||0.38|-0.23|0.624
70905709|NCT04362137|141300671|SUPERIORITY||Odds Ratio (OR)|0.94||||0.944|TWO_SIDED|95.0|0.2|5.57|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \< 1 favors the ruxolitinib 5 mg arm|Day 15||5.57|0.20|0.944
70905710|NCT04362137|141300671|SUPERIORITY||Odds Ratio (OR)|1.21||||0.775|TWO_SIDED|95.0|0.35|5.11|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \< 1 favors the ruxolitinib 5 mg arm|Day 29||5.11|0.35|0.775
70905711|NCT04362137|141300672|SUPERIORITY||Odds Ratio (OR)|0.99||||0.987|TWO_SIDED|95.0|0.45|2.21|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \< 1 favors the ruxolitinib 5 mg arm|||2.21|0.45|0.987
70905712|NCT04362137|141300673|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.738|TWO_SIDED|95.0|0.84|1.28|||Proportional hazards model||Between group comparison using competing risk framework. A hazard ratio \> 1 favors the ruxolitinib 5 mg arm|||1.28|0.84|0.738
70905713|NCT04362137|141300674|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.869|TWO_SIDED|95.0|0.84|1.23|||Proportional hazards model||Between group comparison using competing risk framework. A hazard ratio \> 1 favors the ruxolitinib 5 mg arm|||1.23|0.84|0.869
70905714|NCT04362137|141300677|SUPERIORITY||Odds Ratio (OR)|0.61||||0.325|TWO_SIDED|95.0|0.23|1.63|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \> 1 favors the ruxolitinib 5 mg arm|Day 15||1.63|0.23|0.325
70905715|NCT04362137|141300677|SUPERIORITY||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.25|5.4||P-value was not estimable because \>97% patients fall into one category (responders) in both groups, and very few patients fall into the other one (non-responders), which made the logistic regression model fail to converge even with Firth's correction|Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \> 1 favors the ruxolitinib 5 mg arm|Day 29||5.40|0.25|
70905716|NCT01304082|141300683|SUPERIORITY_OR_OTHER|||||||0.7535||||||Bonferroni correction for pairwise comparisons|non-parametric Friedman ANOVA test|||"Analysis: Non-parametric Friedman ANOVA test on rank-transformed outcome with Bonferroni correction for pairwise comparisons.~Null hypothesis: No difference between the groups"||||0.7535
70905717|NCT01304082|141300684|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Bonferroni correction for pairwise comparisons|non-parametric Friedman ANOVA test|||"Analysis: Non-parametric Friedman ANOVA test on rank-transformed outcome with Bonferroni correction for pairwise comparisons.~Null hypothesis: No difference between the groups"||||<0.0001
70905718|NCT01304082|141300685|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Bonferroni correction for pairwise comparisons|non-parametric Friedman ANOVA test|||"Analysis: Non-parametric Friedman ANOVA test on rank-transformed outcome with Bonferroni correction for pairwise comparisons.~Null hypothesis: No difference between the groups"||||<0.0001
70905719|NCT01304082|141300686|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Bonferroni correction for pairwise comparisons|non-parametric Friedman ANOVA test|||"Analysis: Non-parametric Friedman ANOVA test on rank-transformed outcome with Bonferroni correction for pairwise comparisons.~Null hypothesis: No difference between the groups"||||<0.0001
70905720|NCT02262260|141300687|NON_INFERIORITY|"In order to demonstrate that the wait and extend regimen of ranibizumab is non-inferior to the posology described in the prescribing information, mean change in BCVA at month 12 from the baseline visit were determined for both treatment groups, and a comparison was made between the two groups using the Independent Samples t-test."||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
70905721|NCT02262260|141300688|NON_INFERIORITY|"In order to demonstrate that the wait and extend regimen of ranibizumab is non-inferior to the posology described in the prescribing information, mean change in Central Retinal Thickness determined with Optical Coherence Tomography for both eyes were calculated for both groups and were compared using the Mann Whitney u test."||||||0.082|||||||Wilcoxon (Mann-Whitney)|||||||0.082
70905722|NCT02262260|141300691|NON_INFERIORITY|Comparison was made between the two groups using the Independent Samples t-test.||||||0.095|||||||Chi-squared|||||||0.095
70905723|NCT02262260|141300692|NON_INFERIORITY|comparison was made between the two groups using the Independent Samples t-test.||||||0.072|||||||Chi-squared|||||||0.072
70905724|NCT02262260|141300693|NON_INFERIORITY|comparison was made between the two groups using the Independent Samples t-test||||||0.466|||||||Chi-squared|||||||0.466
70905725|NCT01794117|141300702|SUPERIORITY|||||||0.033|||||||Wilcoxon Signed Rank Test|||||||0.033
70905726|NCT00610701|141300704|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||||||>0.05
70905727|NCT01152294|141300705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.6|STANDARD_DEVIATION|2.4||0.01|TWO_SIDED|95.0|1.02|7.96|||t-test, 2 sided|||We tested for a difference in the mean total knowledge score between the decision aid and control groups using independent t-test (2 sided). With 100 patients in each arm, the study had more than 90% power to detect a 10% difference in knowledge assuming a common standard deviation of 18%.||7.96|1.02|0.01
70905728|NCT01567865|141300745|EQUIVALENCE|The 3 lots of new GMP facility LJEVac would be considered equivalent (i.e., the SP does not differ between lots by ≥10%) if all 3 null hypotheses are rejected, and the alternate hypotheses are accepted.|Mean Difference (Net)|1.84|||||TWO_SIDED|95.0|-5.97|9.66||||||"Null hypotheses: each new lot does not differ in seroprotection (SP) rates among each other by more than 10%.~Slower than anticipated enrollment resulted in a smaller number of subjects with antibody response data for analysis. Consequently, additional power estimates were made in anticipation of the occurrence of smaller sample sizes. With a total study population of only 772 subjects, the power of the study to test lot-to-lot consistency declined from 90% to 85%."||9.66|-5.97|
70905729|NCT01567865|141300745|EQUIVALENCE|The 3 lots of new GMP facility LJEVac would be considered equivalent (i.e., the SP does not differ between lots by ≥10%) if all 3 null hypotheses are rejected, and the alternate hypotheses are accepted.|Mean Difference (Net)|-2.48|||<|0.05|TWO_SIDED|95.0|-9.92|4.98|||t-test, 2 sided|The 95% CI for the difference in rates is calculated based on the Newcombe-Wilson method without continuity correction.||"Null hypotheses: each new lot does not differ in seroprotection (SP) rates among each other by more than 10%.~Slower than anticipated enrollment resulted in a smaller number of subjects with antibody response data for analysis. Consequently, additional power estimates were made in anticipation of the occurrence of smaller sample sizes. With a total study population of only 772 subjects, the power of the study to test lot-to-lot consistency declined from 90% to 85%."||4.98|-9.92|<0.05
70905730|NCT01567865|141300745|EQUIVALENCE|The 3 lots of new GMP facility LJEVac would be considered equivalent (i.e., the SP does not differ between lots by ≥10%) if all 3 null hypotheses are rejected, and the alternate hypotheses are accepted.|Mean Difference (Net)|-4.33|||<|0.05|TWO_SIDED|95.0|-11.94|3.31|||t-test, 2 sided|||"Null hypotheses: each new lot does not differ in seroprotection (SP) rates among each other by more than 10%.~Slower than anticipated enrollment resulted in a smaller number of subjects with antibody response data for analysis. Consequently, additional power estimates were made in anticipation of the occurrence of smaller sample sizes. With a total study population of only 772 subjects, the power of the study to test lot-to-lot consistency declined from 90% to 85%."||3.31|-11.94|<0.05
70905731|NCT01567865|141300745|NON_INFERIORITY|The new GMP facility lots will be considered non-inferior (i.e., equivalent) to the existing facility lot if the null hypothesis is rejected and the alternate hypothesis is accepted.|Mean Difference (Net)|-4.03|||<|0.05|TWO_SIDED|95.0|-9.74|3.1|||t-test, 2 sided|The 95% CI for the difference in rates is calculated based on the Newcombe-Wilson method without continuity correction.||"Null hypothesis: reference lot vs. Lot 1, 2, and 3 combined do differ in seroprotection (SP) rates among each other by more than 10%.~Slower than anticipated enrollment resulted in a smaller number of subjects with antibody response data for analysis. Consequently, additional power estimates were made in anticipation of the occurrence of smaller sample sizes. The power of the study to test non-inferiority of the combined new lots compared to the reference lot dropped from 99% to 87%."||3.1|-9.74|<0.05
70905732|NCT00309608|141300750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.95|-0.39||There was no adjustment for multiple testing, however a hierarchy approach to control for the Type-I error was used. If the 10mg was not successful, any analysis of the 5mg will be descriptive, and similarly for the next step for the 1mg.|Pairwise comparison based on ANCOVA|||"Linagliptin 10 mg vs. Placebo~Missing endpoints after 12 weeks of treatment were replaced using Last Observation Carried Forward (LOCF)"||-0.39|-0.95|<0.0001
70905733|NCT00309608|141300750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-1.01|-0.44||There was no adjustment for multiple testing, however a hierarchy approach to control for the Type-I error was used. If the 10mg was not successful, any analysis of the 5mg will be descriptive, and similarly for the next step for the 1mg.|Pairwise comparison based on ANCOVA|||"Linagliptin 5 mg vs. Placebo~missing endpoints after 12 weeks of treatment were replaced using Last Observation Carried Forward (LOCF)"||-0.44|-1.01|<0.0001
70905734|NCT00309608|141300750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.0055||95.0|-0.68|-0.12||There was no adjustment for multiple testing, however a hierarchy approach to control for the Type-I error was used. If the 10mg was not successful, any analysis of the 5mg will be descriptive, and similarly for the next step for the 1mg.|Pairwise comparison based on ANCOVA|||"Linagliptin 1 mg vs. Placebo~Missing endpoints after 12 weeks of treatment were replaced using Last Observation Carried Forward (LOCF)"||-0.12|-0.68|0.0055
70905735|NCT00309608|141300750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.99|-0.46|||Pairwise comparison based on ANCOVA|||"Placebo vs. Linagliptin 10 mg~Analysis additionally adjusted for previous anti-diabetic medication.~Missing endpoints after 12 weeks of treatment were replaced using Last Observation Carried Forward (LOCF)."||-0.46|-0.99|<0.0001
70905736|NCT00309608|141300750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-1.02|-0.48|||Pairwise comparison based on ANCOVA|||"Linagliptin 5 mg vs. Placebo~Analysis additionally adjusted for previous anti-diabetic medication.~Missing endpoints after 12 weeks of treatment were replaced using last observation carried forward (LOCF)."||-0.48|-1.02|<0.0001
70905737|NCT00309608|141300750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.14||0.0049||95.0|-0.66|-0.12|||Pairwise comparison based on ANCOVA|||"Linagliptin 1 mg vs. Placebo~Analysis additionally adjusted for previous anti-diabetic medication.~Missing endpoints after 12 weeks of treatment were replaced using last observation carried forward (LOCF)."||-0.12|-0.66|0.0049
70905738|NCT00309608|141300751|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|18.575||||0.0054|TWO_SIDED|95.0|2.367|145.781|||Regression, Logistic|||Linagliptin 10 mg vs. Placebo||145.781|2.367|0.0054
70905739|NCT00309608|141300751|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.715||||0.0214|TWO_SIDED|95.0|1.439|95.351|||Regression, Logistic|||Linagliptin 5 mg vs. Placebo||95.351|1.439|0.0214
70905740|NCT00309608|141300751|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.776||||0.0167|TWO_SIDED|95.0|1.586|102.895|||Regression, Logistic|||Linagliptin 1 mg vs. Placebo||102.895|1.586|0.0167
70905741|NCT00309608|141300751|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|31.36||||0.001|TWO_SIDED|95.0|4.063|242.028|||Regression, Logistic|||Glimepiride vs. Placebo||242.028|4.063|0.0010
70905742|NCT00309608|141300752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.5|STANDARD_ERROR_OF_MEAN|6.07|<|0.0001||95.0|-41.4|-17.5|||Pairwise comparison based on ANCOVA|||Linagliptin 10mg vs. Placebo||-17.5|-41.4|<0.0001
70905743|NCT00309608|141300752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-34.92|STANDARD_ERROR_OF_MEAN|6.16|<|0.0001||95.0|-47.0|-22.8|||Pairwise comparison based on ANCOVA|||Linagliptin 5mg vs. Placebo||-22.8|-47.0|<0.0001
70905744|NCT00309608|141300752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.95|STANDARD_ERROR_OF_MEAN|6.13||0.0022||95.0|-31.0|-6.87|||Pairwise comparison based on ANCOVA|||Linagliptin 1 mg vs. Placebo||-6.87|-31.0|0.0022
70905745|NCT02906683|141300796|SUPERIORITY||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|6.8||0.329|TWO_SIDED|95.0|-20.1|6.7|||t-test, 2 sided|||TAS-303 3 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 8||6.7|-20.1|0.329
70905746|NCT02906683|141300796|SUPERIORITY||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|6.84||0.285|TWO_SIDED|95.0|-20.9|6.2|||t-test, 2 sided|||TAS-303 6 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 8||6.2|-20.9|0.285
70905747|NCT02906683|141300798|SUPERIORITY||Mean Difference (Final Values)|-11.3|STANDARD_ERROR_OF_MEAN|6.48||0.082|TWO_SIDED|95.0|-24.1|1.5|||t-test, 2 sided|||TAS-303 3 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 4||1.5|-24.1|0.082
70905748|NCT02906683|141300798|SUPERIORITY||Mean Difference (Final Values)|-12.1|STANDARD_ERROR_OF_MEAN|6.34||0.057|TWO_SIDED|95.0|-24.7|0.4|||t-test, 2 sided|||TAS-303 6 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 4||0.4|-24.7|0.057
70905749|NCT02906683|141300800|SUPERIORITY||Mean Difference (Final Values)|-17.6|STANDARD_ERROR_OF_MEAN|7.38||0.019|TWO_SIDED|95.0|-32.2|-3.0|||t-test, 2 sided|||TAS-303 3 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 4||-3.0|-32.2|0.019
70905750|NCT02906683|141300800|SUPERIORITY||Mean Difference (Final Values)|-16.9|STANDARD_ERROR_OF_MEAN|7.36||0.023|TWO_SIDED|95.0|-31.5|-2.3|||t-test, 2 sided|||TAS-303 6 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 4||-2.3|-31.5|0.023
70905751|NCT02906683|141300802|SUPERIORITY||Mean Difference (Final Values)|-11.4|STANDARD_ERROR_OF_MEAN|7.36||0.125|TWO_SIDED|95.0|-25.9|3.2|||t-test, 2 sided|||TAS-303 3 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 8||3.2|-25.9|0.125
70905752|NCT02906683|141300802|SUPERIORITY||Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|7.8||0.221|TWO_SIDED|95.0|-25.1|5.9|||t-test, 2 sided|||TAS-303 6 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 8||5.9|-25.1|0.221
70905753|NCT01242176|141300824|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|101.67|STANDARD_DEVIATION|6.7|||TWO_SIDED|90.0|98.1|105.37|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV).|Ratio calculated as empa final formulation divided by empa trial formulation 2||105.37|98.10|
70905754|NCT01242176|141300825|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|99.46|STANDARD_DEVIATION|18.7|||TWO_SIDED|90.0|90.18|109.68|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV.|Ratio calculated as empa final formulation divided by empa trial formulation 2||109.68|90.18|
70905755|NCT01242176|141300826|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|101.8|STANDARD_DEVIATION|6.7|||TWO_SIDED|90.0|98.26|105.48|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV.|Ratio calculated as empa final formulation divided by empa trial formulation 2||105.48|98.26|
70905756|NCT00999661|141300865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|39.8|STANDARD_DEVIATION|25.12|<|0.0001||95.0|36.6|43.1||One-sample t-test for change from baseline|t-test, 2 sided|||||43.1|36.6|<0.0001
70905757|NCT00999661|141300866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.6|STANDARD_DEVIATION|19.79|<|0.0001||95.0|34.0|39.2|||t-test, 2 sided|||||39.2|34.0|<0.0001
70905758|NCT00999661|141300867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.97|STANDARD_DEVIATION|5.233|<|0.0001||95.0|-8.65|-7.29|||t-test, 2 sided|||||-7.29|-8.65|<0.0001
70905759|NCT01987596|141300899|SUPERIORITY|||||||1|||||||McNemar|||||||1.00
70905760|NCT01987596|141300900|SUPERIORITY||||||<|0.0001|||||||ANOVA|||two-period crossover design analysis||||<0.0001
70905761|NCT01987596|141300901|SUPERIORITY||||||<|0.0001|||||||ANOVA|||2 treatment, 2 periiod cross-over analysis||||<0.0001
70905762|NCT01421589|141300940|SUPERIORITY_OR_OTHER|||||||0.02|||||||Regression, Linear|||Univariate regression analyses was performed to assess the relationship between change in skeletal muscle IGF-1 mRNA expression after 12 weeks treatment with rhGH and change in ViPCr.||||0.02
70905763|NCT01421589|141300941|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
70905764|NCT01421589|141300942|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70905765|NCT01421589|141300943|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70905766|NCT01421589|141300944|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70905767|NCT01421589|141300945|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70905768|NCT01421589|141300946|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
70905769|NCT02441946|141300977|SUPERIORITY||Ratio of Geometric Means|0.19|||<|0.001|TWO_SIDED|90.0|0.13|0.28|||t-test, 1 sided|||||0.28|0.13|<0.001
70905770|NCT02441946|141300977|SUPERIORITY||Ratio of Geometric Means|0.25|||<|0.001|TWO_SIDED|90.0|0.17|0.38|||t-test, 1 sided|||||0.38|0.17|<0.001
70905771|NCT00759772|141300987|SUPERIORITY||||||<|0.01||||||Calculated p-value.|t-test, 2 sided|||||||< 0.01
70905772|NCT04548531|141301028|SUPERIORITY||Mean Difference (Final Values)|0.67|||<|0.001|TWO_SIDED|95.0|0.41|0.94|||t-test, 2 sided|||||0.94|0.41|<.001
70905773|NCT04548531|141301029|SUPERIORITY||Risk Difference (RD)|21.0||||0.003|TWO_SIDED|95.0|7.0|35.0|||Chi-squared|||||35|7|0.003
70905774|NCT04548531|141301030|SUPERIORITY||Risk Difference (RD)|3.0||||0.75|TWO_SIDED|95.0|-10.0|16.0|||Chi-squared|||We tested for a clear preference for screening, if a patient chose a colonoscopy or a stool-based test vs. the other response options.||16|-10|.75
70905775|NCT04548531|141301031|SUPERIORITY||Risk Difference (RD)|11.0||||0.14|TWO_SIDED|95.0|-3.0|26.0|||Chi-squared|||We categorized for likelihood to follow through with screening. We reported on results from patients who indicated 'Very Likely' on their response option vs. the other options (likely, unsure, unlikely, very unlikely)||26|-3|0.14
70905776|NCT04548531|141301032|SUPERIORITY||Risk Difference (RD)|13.0|||<|0.001|TWO_SIDED|95.0|6.0|18.0|||Chi-squared|||Assessed how many patients completed any colorectal cancer screening test within 6-months after randomization.||18|6|<.001
70905777|NCT00737061|141301044|SUPERIORITY_OR_OTHER||Pregnancy Prevention Rate|98.9||||||95.0|97.9|100.0||||||1-sided confidence interval. No statistical hypothesis testing was performed. Confidence interval represents a 1-sided confidence interval for the pregnancy prevention rate in the EASE Trial. 95% confidence interval derived using Kaplan Meier methods (log-log with PETO adjustment).||100|97.9|
70905778|NCT00737061|141301044|SUPERIORITY_OR_OTHER||Pregnancy Prevention Rate|98.9||||||95.0|97.6|99.5||||||2-sided confidence interval. No statistical hypothesis testing was performed. Confidence interval represents a 2-sided confidence interval for the pregnancy prevention rate in the EASE Trial. 95% confidence interval derived using Kaplan Meier methods (log-log with PETO adjustment).||99.5|97.6|
70905779|NCT00737061|141301054|SUPERIORITY_OR_OTHER||Pregnancy Prevention Rate|98.4||||||95.0|97.2|100.0||||No statistical hypothesis testing was performed.||"1-sided Confidence Interval.~No hypothesis testing was performed. Confidence interval represents a 1-sided confidence interval for the pregnancy prevention rate in the EASE trial. 95% confidence interval derived using Kaplan Meier methods (log-log with PETO adjustment)."||100|97.2|
70905780|NCT00737061|141301054|SUPERIORITY_OR_OTHER||Pregnancy Prevention Rate|98.4||||||95.0|96.9|99.1||||No statistical hypothesis testing was performed.||"2-sided Confidence Interval~No hypothesis testing was performed. Confidence interval represents a 2-sided confidence interval for the pregnancy prevention rate in the EASE trial. 95% confidence interval derived using Kaplan Meier methods (log-log with PETO adjustment)."||99.1|96.9|
70905781|NCT01844115|141301057|SUPERIORITY||Least Squares Mean Difference|-2.2||||0.0048|TWO_SIDED|95.0|-3.72|-0.68|||MMRM|||||-0.68|-3.72|0.0048
70905782|NCT01844115|141301058|SUPERIORITY||Least Squares Mean Difference|-1.89||||0.0236|TWO_SIDED|95.0|-3.52|-0.26|||MMRM|||||-0.26|-3.52|0.0236
70905783|NCT01108510|141301107|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: ATV+COBI+FTC/TDF group was at least 12% worse than the ATV+RTV+FTC/TDF group; alternative hypothesis: ATV+COBI+FTC/TDF group was less than 12% worse than the ATV+RTV+FTC/TDF group. ATV+COBI+FTC/TDF was noninferior if the lower bound of the 2-sided 95.2% confidence interval (CI) (COBI group - RTV group) was \> -12%.|Difference in percentages|-2.2|||||TWO_SIDED|95.2|-7.4|3.0|||||Difference in percentages of success and its 95.2% confidence interval (CI) were calculated based on baseline HIV-1 RNA stratum-adjusted Mantel-Haenszel (MH) proportion.|700 planned subjects had 95% power to evaluate noninferiority assuming a response rate of 79.5% for both arms and a noninferiority margin of 12%.||3.0|-7.4|
70905784|NCT01108510|141301108|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than the response rate in ATV+RTV+FTC/TDF group; the alternative hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group.|Difference in percentages|-1.4|||||TWO_SIDED|95.0|-7.6|4.7|||||Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.|||4.7|-7.6|
70905785|NCT01108510|141301109|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than the response rate in ATV+RTV+FTC/TDF group; the alternative hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group.|Difference in percentages|-2.1|||||TWO_SIDED|95.0|-8.7|4.5|||||Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.|||4.5|-8.7|
70905786|NCT01108510|141301110|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than the response rate in ATV+RTV+FTC/TDF group; the alternative hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group.|Difference in percentages|-8.0|||||TWO_SIDED|95.0|-22.2|6.3|||||Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.|||6.3|-22.2|
70905787|NCT01108510|141301111|SUPERIORITY_OR_OTHER||Difference in least squares mean (LSM)|-5.0||||0.67|TWO_SIDED|95.0|-28.0|18.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||18|-28|0.67
70905788|NCT01108510|141301112|SUPERIORITY_OR_OTHER||Difference in LSM|-10.0||||0.51|TWO_SIDED|95.0|-38.0|19.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||19|-38|0.51
70905789|NCT01108510|141301113|SUPERIORITY_OR_OTHER||Difference in LSM|-22.0||||0.18|TWO_SIDED|95.0|-54.0|10.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||10|-54|0.18
70905790|NCT01108510|141301114|SUPERIORITY_OR_OTHER||Difference in LSM|6.0||||0.84|TWO_SIDED|95.0|-55.0|67.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||67|-55|0.84
70905791|NCT03657264|141301158|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.73|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|90.0|-1.23|2.69||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 5 min||2.69|-1.23|
70905792|NCT03657264|141301158|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|90.0|-1.32|2.29||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 10 min||2.29|-1.32|
70905793|NCT03657264|141301158|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-1.76|2.08||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 20 min||2.08|-1.76|
70905794|NCT03657264|141301158|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-1.09|2.35||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 30 min||2.35|-1.09|
70905795|NCT03657264|141301158|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|90.0|-1.88|2.25||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 1 hour||2.25|-1.88|
70905796|NCT03657264|141301158|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.45|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-1.47|2.37||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 1.5 hours||2.37|-1.47|
70905797|NCT03657264|141301158|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|90.0|-1.99|1.92||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 2 hours||1.92|-1.99|
70967408|NCT01431274|141440929|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.142|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.091|0.192||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.192|0.091|<0.0001
70905798|NCT03657264|141301158|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|2.39|STANDARD_ERROR_OF_MEAN|1.23|||TWO_SIDED|90.0|0.35|4.43||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 3 hours||4.43|0.35|
70905799|NCT03657264|141301158|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|90.0|-1.57|2.12||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 4 hours||2.12|-1.57|
70905800|NCT03657264|141301158|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|1.11|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|90.0|-1.15|3.37||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 8 hours||3.37|-1.15|
70905801|NCT03657264|141301158|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|90.0|-1.52|2.14||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 24 hours||2.14|-1.52|
70905802|NCT03657264|141301158|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|4.81|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|90.0|2.84|6.78||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 5 min||6.78|2.84|
70905803|NCT03657264|141301158|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|1.93|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|90.0|0.12|3.73||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 10 min||3.73|0.12|
70905804|NCT03657264|141301158|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-1.71|2.12||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 20 min||2.12|-1.71|
70905805|NCT03657264|141301158|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-1.29|2.15||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 30 min||2.15|-1.29|
70905806|NCT03657264|141301158|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.47|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|90.0|-1.6|2.53||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 1 hour||2.53|-1.60|
70905807|NCT03657264|141301158|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-1.11|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-3.03|0.81||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 1.5 hours||0.81|-3.03|
70905808|NCT03657264|141301158|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-1.17|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|90.0|-3.13|0.78||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 2 hours||0.78|-3.13|
70905809|NCT03657264|141301158|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|1.23|||TWO_SIDED|90.0|-3.36|0.71||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 3 hours||0.71|-3.36|
70905810|NCT03657264|141301158|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|90.0|-2.69|1.0||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 4 hours||1.00|-2.69|
70905811|NCT03657264|141301158|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-1.94|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|90.0|-4.19|0.32||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 8 hours||0.32|-4.19|
70905812|NCT03657264|141301158|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|90.0|-1.62|2.04||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 24 hours||2.04|-1.62|
70905813|NCT03657264|141301159|SUPERIORITY|The lower limit of the adjusted confidence interval was expected upper to the margin of 5 milliseconds.|Least Squares Mean Difference|4.62|STANDARD_ERROR_OF_MEAN|1.23|||TWO_SIDED|90.0|2.58|6.66||p-value is not shown, as this is a non-inferiority study.|ANCOVA|As multiple timepoints were examined separately, the overall type I error rate needed to be adjusted.||For the timepoint 1 hour||6.66|2.58|
70905814|NCT03657264|141301159|SUPERIORITY|The lower limit of the adjusted confidence interval was expected upper to the margin of 5 milliseconds.|Least Squares Mean Difference|9.4|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|7.14|11.66||p-value is not shown, as this is a non-inferiority study.|ANCOVA|As multiple timepoints were examined separately, the overall type I error rate needed to be adjusted.||For the timepoint 1.5 hours||11.66|7.14|
70905815|NCT03657264|141301159|SUPERIORITY|The lower limit of the adjusted confidence interval was expected upper to the margin of 5 milliseconds.|Least Squares Mean Difference|10.55|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|7.92|13.17||p-value is not shown, as this is a non-inferiority study.|ANCOVA|As multiple timepoints were examined separately, the overall type I error rate needed to be adjusted.||For the timepoint 2 hours||13.17|7.92|
70905816|NCT03657264|141301159|SUPERIORITY|The lower limit of the adjusted confidence interval was expected upper to the margin of 5 milliseconds.|Least Squares Mean Difference|10.33|STANDARD_ERROR_OF_MEAN|1.22|||TWO_SIDED|90.0|7.7|12.95||p-value is not shown, as this is a non-inferiority study.|ANCOVA|As multiple timepoints were examined separately, the overall type I error rate needed to be adjusted.||For the timepoint 3 hours||12.95|7.70|
70905817|NCT03657264|141301159|SUPERIORITY|The lower limit of the adjusted confidence interval was expected upper to the margin of 5 milliseconds.|Least Squares Mean Difference|10.65|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|90.0|8.05|13.25||p-value is not shown, as this is a non-inferiority study.|ANCOVA|As multiple timepoints were examined separately, the overall type I error rate needed to be adjusted.||For the timepoint 4 hours||13.25|8.05|
70905818|NCT00924469|141301164|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.61||||0.0216||90.0|0.429|0.865||Test for no difference of natural log transformed values between treatments was calculated using two-way analysis of variance (ANOVA) adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 1 for testosterone concentration at Week 12||0.865|0.429|0.0216
70905819|NCT00924469|141301165|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.43||||0.1423||90.0|0.956|2.145||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 1 for testosterone concentration at Week 24||2.145|0.956|0.1423
70905820|NCT00924469|141301165|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.82||||0.6639||90.0|0.386|1.746||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 2 for DHT concentration at Week 24||1.746|0.386|0.6639
70905821|NCT00924469|141301166|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.32|||<|0.0001||90.0|0.239|0.418||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 1 for androstenedione concentration at Week 12||0.418|0.239|<0.0001
70905822|NCT00924469|141301166|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.13||||0.5061||90.0|0.828|1.554||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 2 for androstenedione concentration at Week 24||1.554|0.828|0.5061
70905823|NCT00924469|141301166|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.03|||<|0.0001||90.0|0.017|0.05||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 3 for DHEA concentration at Week 12||0.050|0.017|<0.0001
70905824|NCT00924469|141301166|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.79||||0.5767||90.0|0.398|1.581||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 4 for DHEA concentration at Week 24||1.581|0.398|0.5767
70905825|NCT00924469|141301167|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.14|||<|0.0001||90.0|0.097|0.207||Test for no difference of natural log transformed values between treatments was calculated using analysis of covariance (ANCOVA) adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 1 for serum testosterone concentration at Week 12||0.207|0.097|<0.0001
70905826|NCT00924469|141301167|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.84||||0.4364||90.0|0.571|1.225||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 2 for serum testosterone concentration at Week 24||1.225|0.571|0.4364
70905827|NCT00924469|141301167|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.75||||0.1515||90.0|0.54|1.044||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 3 for serum DHT concentration at Week 12||1.044|0.540|0.1515
70905828|NCT00924469|141301167|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.84||||0.3965||90.0|0.589|1.188||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 4 for serum DHT concentration at Week 24||1.188|0.589|0.3965
70905829|NCT00924469|141301167|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.42||||0.0003||90.0|0.29|0.615||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 5 for serum Androsterone concentration at Week 12||0.615|0.290|0.0003
70905830|NCT00924469|141301167|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.22||||0.2494||90.0|0.916|1.625||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 6 for serum androsterone concentration at Week 24||1.625|0.916|0.2494
70905831|NCT00924469|141301167|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.04|||<|0.0001||90.0|0.023|0.073||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 7 for serum DHEA concentration at Week 12||0.073|0.023|<0.0001
70905832|NCT00924469|141301167|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.24||||0.5144||90.0|0.717|2.137||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 8 for serum DHEA concentration at Week 24||2.137|0.717|0.5144
70905833|NCT00924469|141301167|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.1|||<|0.0001||90.0|0.055|0.189||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 9 for serum DHEA-glucuronide concentration at Week 12||0.189|0.055|<0.0001
70905834|NCT00924469|141301167|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.55||||0.1329||90.0|0.286|1.06||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 10 for serum DHEA-glucuronide concentration at Week 24||1.060|0.286|0.1329
70905835|NCT00924469|141301167|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.01|||<|0.0001||90.0|0.008|0.028||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 11 for serum DHEA-sulfate concentration at Week 12||0.028|0.008|<0.0001
70905836|NCT00924469|141301167|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.2||||0.7061||90.0|0.53|2.73|||ANCOVA|||Statistical Analysis 12 for serum DHEA-sulfate concentration at Week 24||2.730|0.530|0.7061
70905837|NCT00924469|141301167|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.42|||<|0.0001||90.0|0.29|0.615||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 13 for serum delta-4-androstenedione concentration at Week 12||0.615|0.290|<0.0001
70905838|NCT00924469|141301167|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.22||||0.2673||90.0|0.916|1.625||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 14 for serum delta-4-androstenedione concentration at Week 24||1.625|0.916|0.2673
70905839|NCT00924469|141301168|SUPERIORITY_OR_OTHER||Relative risk|25.533|||<|0.0001||90.0|4.989|130.68|||Cochran-Mantel-Haenszel|||Statistical Analysis 1 for PSA response at Week 12||130.680|4.989|<0.0001
70905840|NCT00924469|141301168|SUPERIORITY_OR_OTHER||Relative risk|1.131||||0.2319||90.0|0.956|1.337|||Cochran-Mantel-Haenszel|||Statistical Analysis 2 for PSA response at Week 24||1.337|0.956|0.2319
70905841|NCT00924469|141301169|SUPERIORITY_OR_OTHER||Relative risk|2.744||||0.3427||90.0|1.018|5.015|||Cochran-Mantel-Haenszel|||Statistical Analysis 1 for CR at Week 24||5.015|1.018|0.3427
70905842|NCT00924469|141301172|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.17|||<|0.0001||90.0|0.098|0.289||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 2 for DHT concentration at Week 12||0.289|0.098|<0.0001
70905843|NCT03745794|141301235|OTHER|||||||0.17|||||||Chi-squared|||||||0.17
70905844|NCT02733042|141301269|OTHER|||||||||||||||||The safety review committee identified a preliminary recommended Phase 2 dose (RP2D) for each dose finding cohort based on an integrated assessment of the safety, pharmacokinetic, pharmacodynamic, and preliminary efficacy (as available).|For Arm B, ibrutinib 420 mg was confirmed as the RP2D for CLL/SLL participants and ibrutinib 560 mg was confirmed as the RP2D for MCL participants.|||
70905845|NCT02733042|141301269|OTHER|||||||||||||||||The safety review committee identified a preliminary recommended Phase 2 dose (RP2D) for each dose finding cohort based on an integrated assessment of the safety, pharmacokinetic, pharmacodynamic, and preliminary efficacy (as available).|For Arm C the RP2D was confirmed as rituximab 375 mg/m² + bendamustine 70 mg/m².|||
70905846|NCT00180713|141301319|SUPERIORITY|||||||0.028|||||||ANOVA|||||||0.028
70905847|NCT00180713|141301320|SUPERIORITY|||||||0.86|||||||ANOVA|||Analysis was performed by intention to treat at 6 months and per protocol at 12 months. Missing variables were replaced with medians or means (for variables missing at baseline) or with expected variables calculated on the percentage change between baseline and 24 weeks observed for the group (placebo or statin) as a whole (a technique called imputation). Missing variables accounted for less than 5% of the data and there were no missing CMR data at baseline.||||0.86
70905848|NCT00180713|141301321|SUPERIORITY|||||||0.4|||||||ANOVA|||Analysis was performed by intention to treat at 6 months and per protocol at 12 months. Missing variables were replaced with medians or means (for variables missing at baseline) or with expected variables calculated on the percentage change between baseline and 24 weeks observed for the group (placebo or statin) as a whole (a technique called imputation). Missing variables accounted for less than 5% of the data and there were no missing CMR data at baseline.||||0.4
70905849|NCT00180713|141301322|SUPERIORITY|||||||0.041|||||||ANOVA|||||||0.041
70905850|NCT00180713|141301323|SUPERIORITY|||||||0.26|||||||ANOVA|||||||0.26
70905851|NCT04424290|141301377|OTHER||Adjusted mean difference|-0.0234|STANDARD_ERROR_OF_MEAN|0.0157|||TWO_SIDED|95.0|-0.0558|0.0089|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||0.0089|-0.0558|
70905852|NCT04424290|141301378|OTHER||Adjusted mean difference|0.0215|STANDARD_ERROR_OF_MEAN|0.0429|||TWO_SIDED|95.0|-0.067|0.11|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||0.1100|-0.0670|
70905853|NCT04424290|141301379|OTHER||Adjusted mean difference|-0.0109|STANDARD_ERROR_OF_MEAN|0.0145|||TWO_SIDED|95.0|-0.0412|0.0195|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||0.0195|-0.0412|
70905854|NCT04424290|141301380|OTHER||Adjusted mean difference|-0.0228|STANDARD_ERROR_OF_MEAN|0.0603|||TWO_SIDED|95.0|-0.1477|0.1021|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||0.1021|-0.1477|
70905855|NCT04424290|141301381|OTHER||Adjusted mean difference|-1.3|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|-8.1|5.5|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||5.5|-8.1|
70905856|NCT04424290|141301382|OTHER||Adjusted mean difference|4.4|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-7.3|16.2|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||16.2|-7.3|
70905857|NCT04424290|141301383|OTHER||Adjusted mean difference|-3.3|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-9.6|3.0|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||3.0|-9.6|
70905858|NCT04424290|141301384|OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|-7.3|6.1|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||6.1|-7.3|
70905859|NCT04424290|141301385|OTHER||Adjusted mean difference|-2.8|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-8.7|3.1|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||3.1|-8.7|
70905860|NCT04424290|141301386|OTHER||Adjusted mean difference|0.2|STANDARD_ERROR_OF_MEAN|2.5|||TWO_SIDED|95.0|-4.9|5.4|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||5.4|-4.9|
70905861|NCT04424290|141301387|OTHER||Adjusted mean difference|2.6|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|95.0|-2.7|7.9|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||7.9|-2.7|
70905862|NCT04424290|141301388|OTHER||Adjusted mean difference|7.7|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-1.2|16.5|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||16.5|-1.2|
70905863|NCT04424290|141301389|OTHER||Adjusted mean difference|13.8|STANDARD_ERROR_OF_MEAN|7.8|||TWO_SIDED|95.0|-2.3|29.8|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||29.8|-2.3|
70905864|NCT04424290|141301390|OTHER||Adjusted mean difference|6.8|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-0.9|14.5|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||14.5|-0.9|
70905865|NCT00806624|141301409|SUPERIORITY_OR_OTHER||difference in percentages|-3.5|||||TWO_SIDED|95.0|-16.2|9.4||||||||9.4|-16.2|
70905866|NCT00806624|141301409|SUPERIORITY_OR_OTHER||difference in percentages|-9.1|||||TWO_SIDED|95.0|-22.4|4.5||||||||4.5|-22.4|
70905867|NCT00806624|141301409|SUPERIORITY_OR_OTHER||difference in percentage|-5.6|||||TWO_SIDED|95.0|-19.3|8.2||||||||8.2|-19.3|
70905868|NCT02771210|141301448|SUPERIORITY||Odds Ratio (OR)|1.63||||0.136|TWO_SIDED|95.0|0.87|3.08|||Regression, Logistic|||||3.08|0.87|0.136
70905869|NCT02694640|141301463|SUPERIORITY|The study was powered to detect significant between-group differences in mean min/week MVPA at follow-up.|effect size|0.11|||<|0.05|TWO_SIDED|||||No adjustment for multiple comparisons was made|Regression, Linear||Effect size refers to between-group difference at follow-up.|A series of longitudinal mixed effects models with subject-specific intercepts were used to examine between-group differences in mean min/week of self reported moderate-to-vigorous physical activity (MVPA).||||<.05
70905870|NCT02694640|141301464|SUPERIORITY||effect size|0.09|||<|0.05|TWO_SIDED||||||Regression, Linear|||||||<.05
70905871|NCT02572817|141301473|SUPERIORITY||Odds Ratio (OR)|1.22||||0.54|TWO_SIDED|95.0|0.65|2.29|||Regression, Logistic|||||2.29|0.65|0.54
70905872|NCT02572817|141301474|SUPERIORITY||Odds Ratio (OR)|0.86||||0.66|TWO_SIDED|95.0|0.45|1.66|||Regression, Logistic|||||1.66|0.45|0.66
70905873|NCT02572817|141301475|SUPERIORITY||Odds Ratio (OR)|0.95||||0.87|TWO_SIDED|95.0|0.5|1.8|||Regression, Logistic|||||1.8|0.5|0.87
70905874|NCT02572817|141301476|SUPERIORITY||Odds Ratio (OR)|1.26||||0.49|TWO_SIDED|95.0|0.65|2.41|||Regression, Logistic|||||2.41|0.65|0.49
70905875|NCT02572817|141301477|SUPERIORITY||Odds Ratio (OR)|1.07||||0.83|TWO_SIDED|95.0|0.55|2.08|||Regression, Logistic|||||2.08|0.55|0.83
70905876|NCT02572817|141301478|SUPERIORITY||Odds Ratio (OR)|1.29||||0.47|TWO_SIDED|95.0|0.65|2.56|||Regression, Logistic|||||2.56|0.65|0.47
70905877|NCT02572817|141301479|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
70905878|NCT02572817|141301480|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.64|TWO_SIDED|95.0|0.21|2.64|||Log Rank|||||2.64|0.21|0.64
70905879|NCT02572817|141301481|SUPERIORITY|||||||0.69|||||||Fisher Exact|||||||0.69
70905880|NCT02572817|141301482|SUPERIORITY||Odds Ratio (OR)|1.33||||0.43|TWO_SIDED|95.0|0.65|2.71|||Regression, Logistic|||Composite mortality and hospitalization, Day 7||2.71|0.65|0.43
70905881|NCT02572817|141301482|SUPERIORITY||Odds Ratio (OR)|1.11||||0.79|TWO_SIDED|95.0|0.5|2.48|||Regression, Logistic|||Composite mortality and hospitalization, Day 14||2.48|0.5|0.79
70905882|NCT02572817|141301482|SUPERIORITY||Odds Ratio (OR)|1.65||||0.29|TWO_SIDED|95.0|0.66|4.12|||Regression, Logistic|||Composite mortality and hospitalization, Day 28||4.12|0.66|0.29
70905883|NCT02572817|141301483|SUPERIORITY||Hodges-Lehman estimate of location shift|-1.0||||0.2|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||Change in NEW from baseline to Day 3||0|-2|0.2
70905884|NCT02572817|141301483|SUPERIORITY||Hodges-Lehman estimate of location shift|0.0||||0.66|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||Change in NEW from baseline to Day 3||1|-1|0.66
70905885|NCT02572817|141301484|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Change in PEW from baseline to Day 3||||0.18
70905886|NCT02572817|141301484|SUPERIORITY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||Change in PEW from baseline to Day 7||||0.61
70905887|NCT02572817|141301485|SUPERIORITY||Hodges-Lehman estimate of location shift|0.0||||0.68|TWO_SIDED|95.0|-2.0|1.0|||Wilcoxon (Mann-Whitney)|||||1|-2|0.68
70905888|NCT02572817|141301486|SUPERIORITY||Odds Ratio (OR)|1.42||||0.98|TWO_SIDED|95.0|0.23|11.01|||Regression, Logistic|||||11.01|0.23|0.98
70905889|NCT02572817|141301487|SUPERIORITY||Hodges-Lehman estimate of location shift|-1.5||||0.37|TWO_SIDED|95.0|-6.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|-6|0.37
70905890|NCT02572817|141301488|SUPERIORITY|||||||0.55|||||||Fisher Exact|||||||0.55
70905891|NCT02572817|141301489|SUPERIORITY||Hodges-Lehman estimate of location shift|-3.0||||0.22|TWO_SIDED|95.0|-14.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|-14|0.22
70905892|NCT02572817|141301490|SUPERIORITY||Odds Ratio (OR)|0.74||||1|TWO_SIDED|95.0|0.08|9.29|||Regression, Logistic|||||9.29|0.08|1
70905893|NCT02572817|141301492|SUPERIORITY||Odds Ratio (OR)|0.33||||0.24|TWO_SIDED|95.0|0.05|1.79|||Regression, Logistic|||||1.79|0.05|0.24
70905894|NCT02572817|141301494|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
70905895|NCT02572817|141301495|SUPERIORITY||Hodges-Lehman estimate of location shift|0.0||||0.06|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||Change in SOFA from baseline to Day 3||0|-1|0.06
70905896|NCT02572817|141301495|SUPERIORITY||Hodges-Lehman estimate of location shift|-1.0||||0.13|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||Change in SOFA from baseline to Day 7||0|-1|0.13
70905897|NCT02572817|141301496|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||Change in PELOD from baseline to Day 3||||0.36
70905898|NCT02572817|141301496|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Change in PELOD from baseline to Day 7||||0.15
70905899|NCT02572817|141301497|SUPERIORITY||Odds Ratio (OR)|1.73||||0.12|TWO_SIDED|95.0|0.87|3.44|||Regression, Logistic|||||3.44|0.87|0.12
70905900|NCT02572817|141301498|SUPERIORITY||Odds Ratio (OR)|0.47||||0.23|TWO_SIDED|95.0|0.13|1.43|||Regression, Logistic|||||1.43|0.13|0.23
70905901|NCT05462652|141301503|SUPERIORITY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|0.53|<|0.001|TWO_SIDED|95.0|-3.68|-1.59|||Mixed Models Analysis|||||-1.59|-3.68|<0.001
70905902|NCT05462652|141301504|SUPERIORITY||Difference in proportion z-test|20.1|||<|0.001|TWO_SIDED|95.0|9.1|31.0|||Chi-squared|||"Missing values imputed with multiple imputation.~P-values are obtained from a Pearson Chi-Squared test; differences and 95% CIs are obtained from a difference in proportions Z- test."||31.0|9.1|<0.001
70905903|NCT05462652|141301505|SUPERIORITY||Difference in proportions z-test|15.4||||0.003|TWO_SIDED|95.0|5.3|25.6|||Chi-squared|||P-values are obtained from a Pearson Chi-Squared test; differences and 95% CIs are obtained from a difference in proportions Z- test.||25.6|5.3|0.003
70905904|NCT05462652|141301506|SUPERIORITY||Difference in proportion z-test|24.7|||<|0.001|TWO_SIDED|95.0|13.0|36.4|||Chi-squared|||Missing values imputed with multiple imputation. P-values are obtained from a Pearson Chi-Squared test; differences and 95% CIs are obtained from a difference in proportions Z- test.||36.4|13.0|<0.001
70905905|NCT00119262|141301508|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED|95.0|||||Fisher Exact|||||||0.12
70905906|NCT00119262|141301509|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Fisher Exact|||||||0.32
70905907|NCT01651936|141301533|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares means|-0.52||||0.308|TWO_SIDED|95.0|-1.54|0.5|||Constrained Longitudinal Data Analysis|||||0.50|-1.54|0.308
70905908|NCT01651936|141301534|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentages|-0.26||||0.91|TWO_SIDED|95.0|-23.52|23.01|||Cochran-Mantel-Haenszel|||||23.01|-23.52|0.91
70905909|NCT01651936|141301536|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentages|8.46||||0.468|TWO_SIDED|95.0|-10.4|27.32|||Cochran-Mantel-Haenszel|||||27.32|-10.40|0.468
70905910|NCT01651936|141301538|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares means|-0.41||||0.038|TWO_SIDED|95.0|-0.79|-0.02|||Constrained Longitudinal Data Analysis|||||-0.02|-0.79|0.038
70905911|NCT02340520|141301562|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
70905912|NCT02340520|141301563|OTHER||||||>|0.1|||||||ANOVA|||||||>0.1
70905913|NCT01586338|141301596|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance = 0.05.|Paired t-test|||||||<0.0001
70905914|NCT01586338|141301596|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Sign Rank Test|||||||<0.0001
70905915|NCT01544491|141301649|NON_INFERIORITY|Kaplan-Meier estimates and between treatment differences are estimated using the Kaplan-Meier product-limit formula and 80% confidence intervals derived using standard errors estimated from Greenwood's formula.|Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|5.25||0.9712|TWO_SIDED|80.0|-6.6|6.8|||Log Rank|||at 12 months||6.8|-6.6|0.9712
70905916|NCT01544491|141301649|NON_INFERIORITY|Kaplan-Meier estimates and between treatment differences are estimated using the Kaplan-Meier product-limit formula and 80% confidence intervals derived using standard errors estimated from Greenwood's formula.|Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|5.84||0.9634|TWO_SIDED|80.0|-7.3|7.7|||Log Rank|||36 months||7.7|-7.3|0.9634
70905917|NCT01544491|141301650|NON_INFERIORITY|KM estimates and between treatment differences are estimated using the Kaplan-Meier product-limit formula and 80% confidence intervals derived using standard errors estimated from Greenwood's formula.|Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|5.26||0.3455|TWO_SIDED|80.0|-1.8|11.8|||t-test, 2 sided|||at 12 months||11.8|-1.8|0.3455
70905918|NCT01544491|141301650|NON_INFERIORITY|KM estimates and between treatment differences are estimated using the Kaplan-Meier product-limit formula and 80% confidence intervals derived using standard errors estimated from Greenwood's formula.|Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|4.95||0.8642|TWO_SIDED|80.0|-5.5|7.2|||t-test, 2 sided|||36 months||7.2|-5.5|0.8642
70905919|NCT00680056|141301695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|56.0|STANDARD_DEVIATION|60.0||0.038||95.0|||||t-test, 2 sided||Mean difference= Formoterol plus Tiotropium minus Formoterol plus Placebo(Tiotropium)|It was calculated a total sample size of a 2x2 cross-over design as 24 for a two-sided t-test achieves 85% power to infer that the mean difference is not zero, the actual mean difference is 20, the standard deviation of the differences is 15, and the significance level is 0.05||||0.038
70905920|NCT00680056|141301696|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.88|STANDARD_DEVIATION|2.39||0.054||95.0|||||t-test, 2 sided||Mean difference=Arm 2 minus Arm 1|||||0.054
70905921|NCT01088529|141301697|SUPERIORITY_OR_OTHER||Relative risk|1.432||||0.2148|TWO_SIDED|90.0|0.859|2.386|||Chi-squared|||||2.386|0.859|0.2148
70905922|NCT01088529|141301698|SUPERIORITY_OR_OTHER||Relative risk|0.477||||0.1796|TWO_SIDED|90.0|0.205|1.109|||Fisher Exact|||||1.109|0.205|0.1796
70905923|NCT01088529|141301699|SUPERIORITY_OR_OTHER||Relative risk|6.523|||<|0.0001|TWO_SIDED|90.0|2.701|15.753|||Chi-squared|||||15.753|2.701|<0.0001
70905924|NCT00337662|141301705|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Between-group p-values for each baseline to post-baseline visit were the same, p\<0.001.|Mixed Effects Model Repeated Measures|||||||<0.001
70905925|NCT00337662|141301706|SUPERIORITY_OR_OTHER|||||||0.266||95.0||||Change from Week 2 to Week 3 p-value|Mixed-Effects Model Repeated-Measures|||||||0.266
70905926|NCT00337662|141301706|SUPERIORITY_OR_OTHER|||||||0.884||95.0||||Change from Week 2 to Week 4 p-value|Mixed-Effects Model Repeated-Measures|||||||0.884
70905927|NCT00337662|141301706|SUPERIORITY_OR_OTHER|||||||0.151||95.0||||Change from Week 2 to Week 6 p-value|Mixed-Effects Model Repeated-Measures|||||||0.151
70905928|NCT00337662|141301706|SUPERIORITY_OR_OTHER|||||||0.216||95.0||||Change from Week 2 to Week 8 p-value|Mixed-Effects Model Repeated-Measures|||||||0.216
70905929|NCT00337662|141301706|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||Change from Week 2 to Week 12 p-value|Mixed-Effects Model Repeated-Measures|||||||0.020
70905930|NCT00337662|141301707|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
70905931|NCT00337662|141301708|SUPERIORITY_OR_OTHER|||||||0.604||95.0|||||Fisher Exact|||||||0.604
70905932|NCT00337662|141301709|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
70905933|NCT00337662|141301710|SUPERIORITY_OR_OTHER|||||||0.745||95.0|||||Fisher Exact|||||||0.745
70905934|NCT00337662|141301711|SUPERIORITY_OR_OTHER|||||||0.474||95.0|||||Fisher Exact|||||||0.474
70905935|NCT00337662|141301712|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.034
70905936|NCT00337662|141301712|SUPERIORITY_OR_OTHER|||||||0.125||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.125
70905937|NCT00337662|141301713|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||All comparisons between EO-RIS and NEO-RIS and between NEO-RIS and NEO-OLZ had p-values greater than 0.05.|Fisher Exact|||||||>0.05
70905938|NCT00337662|141301714|SUPERIORITY_OR_OTHER|||||||0.355||95.0|||||ANOVA|p-value is from ANOVA with treatment and pooled investigator in the model.||||||0.355
70905939|NCT00337662|141301714|SUPERIORITY_OR_OTHER|||||||0.244||95.0|||||ANOVA|p-value is from ANOVA with treatment and pooled investigator in the model.||||||0.244
70905940|NCT00337662|141301715|SUPERIORITY_OR_OTHER|||||||0.998||95.0|||||ANOVA|P-value is from ANOVA with treatment and pooled investigator in the model.||||||0.998
70905941|NCT00337662|141301715|SUPERIORITY_OR_OTHER|||||||0.505||95.0|||||ANOVA|P-value is from ANOVA with treatment and pooled investigator in the model.||||||0.505
70967409|NCT01431274|141440929|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.041|STANDARD_ERROR_OF_MEAN|0.026||0.1112|TWO_SIDED|95.0|-0.009|0.091||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.091|-0.009|0.1112
70905942|NCT00337662|141301716|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||ANOVA|P-value is from ANOVA with treatment and pooled investigator in the model.||||||0.266
70905943|NCT00337662|141301716|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||ANOVA|P-value is from ANOVA with treatment and pooled investigator in the model.||||||0.015
70905944|NCT00337662|141301717|SUPERIORITY_OR_OTHER|||||||0.14||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.140
70905945|NCT00337662|141301717|SUPERIORITY_OR_OTHER|||||||0.181||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.181
70905946|NCT00337662|141301718|SUPERIORITY_OR_OTHER|||||||0.254||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.254
70905947|NCT00337662|141301718|SUPERIORITY_OR_OTHER|||||||0.299||95.0|||||ANOVA|P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.||||||0.299
70905948|NCT00337662|141301719|SUPERIORITY_OR_OTHER|||||||0.291||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.291
70905949|NCT00337662|141301719|SUPERIORITY_OR_OTHER|||||||0.259||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.259
70905950|NCT00337662|141301720|SUPERIORITY_OR_OTHER|||||||0.209||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.209
70905951|NCT00337662|141301720|SUPERIORITY_OR_OTHER|||||||0.411||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.411
70905952|NCT00337662|141301721|SUPERIORITY_OR_OTHER|||||||0.544||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.544
70905953|NCT00337662|141301721|SUPERIORITY_OR_OTHER|||||||0.386||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.386
70905954|NCT00337662|141301722|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.026
70905955|NCT00337662|141301722|SUPERIORITY_OR_OTHER|||||||0.143||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.143
70905956|NCT03691948|141301730|SUPERIORITY|||||||0.531|||||||ANOVA|||||||.531
70905957|NCT03691948|141301731|SUPERIORITY|||||||0.076|||||||ANOVA|||||||0.076
70905958|NCT02611830|141301744|SUPERIORITY||Risk Difference (RD)|32.3|||<|0.001|TWO_SIDED|95.0|19.7|45.0||P-value was calculated by Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-α antagonist failure/concomitant immunomodulator.|Cochran-Mantel-Haenszel|||||45.0|19.7|<0.001
70905959|NCT02611830|141301745|SUPERIORITY||Risk Difference (RD)|35.7|||<|0.001|TWO_SIDED|95.0|22.1|49.3||P-value was calculated by CMH test stratified by randomization strata according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-α antagonist failure/concomitant immunomodulator.|Cochran-Mantel-Haenszel|||||49.3|22.1|<0.001
70905960|NCT02611830|141301746|SUPERIORITY||Risk Difference (RD)|36.1|||<|0.001|TWO_SIDED|95.0|21.2|50.9||P-value was calculated by CMH test stratified by randomization strata according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-α antagonist failure/concomitant immunomodulator.|Cochran-Mantel-Haenszel|||||50.9|21.2|<0.001
70905961|NCT02611830|141301747|SUPERIORITY||Risk Difference (RD)|9.7||||0.076|TWO_SIDED|95.0|-6.6|25.7||P-value was calculated by Fisher's Exact Test.|Fisher Exact|||||25.7|-6.6|0.076
70905962|NCT02611830|141301748|SUPERIORITY||Risk Difference (RD)|20.6||||0.067|TWO_SIDED|95.0|-4.5|43.7||P-value was calculated by Fisher's Exact Test.|Fisher Exact|||||43.7|-4.5|0.067
70905963|NCT02058290|141301761|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
70905964|NCT02058290|141301762|SUPERIORITY_OR_OTHER|||||||0.2612|||||||ANOVA|||||||0.2612
70905965|NCT02058290|141301763|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Log Rank|||||||0.0019
70905966|NCT00405704|141301766|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Log Rank|||||||<0.001
70905967|NCT00405704|141301767|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.55
70905968|NCT00405704|141301768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.37
70905969|NCT00405704|141301769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.94
70905970|NCT00405704|141301770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED||||||Log Rank|||||||0.04
70905971|NCT00405704|141301771|SUPERIORITY_OR_OTHER_LEGACY|||||||0.065|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.065
70905972|NCT00405704|141301772|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
70905973|NCT00405704|141301773|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
70905974|NCT03012061|141301774|SUPERIORITY||Mean Difference (Net)|0.1758|STANDARD_ERROR_OF_MEAN|0.0426|<|0.001|TWO_SIDED|95.0|0.092|0.2595|||Mixed-model repeated measures (MMRM)||UMEC 31.25 mcg versus placebo|||0.2595|0.0920|<0.001
70905975|NCT03012061|141301774|SUPERIORITY||Mean Difference (Net)|0.1841|STANDARD_ERROR_OF_MEAN|0.0424|<|0.001|TWO_SIDED|95.0|0.1008|0.2675|||MMRM||UMEC 62.5 mcg versus placebo|||0.2675|0.1008|<0.001
70905976|NCT03012061|141301775|SUPERIORITY||Mean Difference (Net)|0.1895|STANDARD_ERROR_OF_MEAN|0.0455|<|0.001|TWO_SIDED|95.0|0.1|0.2789||Analysis of covariance (ANCOVA)|ANCOVA||UMEC 31.25 mcg vs Placebo|||0.2789|0.1000|<0.001
70905977|NCT03012061|141301775|SUPERIORITY||Mean Difference (Net)|0.1976|STANDARD_ERROR_OF_MEAN|0.0453|<|0.001|TWO_SIDED|95.0|0.1086|0.2866|||ANCOVA||UMEC 62.5 mcg vs Placebo|||0.2866|0.1086|<0.001
70905978|NCT03012061|141301778|SUPERIORITY||Median Difference (Net)|1.7|STANDARD_ERROR_OF_MEAN|1.0||0.083|TWO_SIDED|95.0|-0.2|3.7|||MMRM||UMEC 31.25 mcg vs Placebo, SBP, Week 4|||3.7|-0.2|0.083
70905979|NCT03012061|141301778|SUPERIORITY||Median Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|1.11||0.636|TWO_SIDED|95.0|-2.7|1.7|||MMRM||UMEC 31.25 mcg vs Placebo, SBP, Week 12|||1.7|-2.7|0.636
70905980|NCT03012061|141301778|SUPERIORITY||Mean Difference (Net)|1.7|STANDARD_ERROR_OF_MEAN|1.1||0.115|TWO_SIDED|95.0|-0.4|3.9|||MMRM||UMEC 31.25 mcg vs Placebo, SBP, Week 24|||3.9|-0.4|0.115
70905981|NCT03012061|141301778|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|0.99||0.336|TWO_SIDED|95.0|-1.0|2.9|||MMRM||UMEC 62.5 mcg vs Placebo, SBP, Week 4|||2.9|-1.0|0.336
70905982|NCT03012061|141301778|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|1.11||0.787|TWO_SIDED|95.0|-1.9|2.5|||MMRM||UMEC 62.5 mcg vs Placebo, SBP, Week 12|||2.5|-1.9|0.787
70905983|NCT03012061|141301778|SUPERIORITY||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|1.1||0.625|TWO_SIDED|95.0|-1.6|2.7|||MMRM||UMEC 62.5 mcg vs Placebo, SBP, Week 24|||2.7|-1.6|0.625
70905984|NCT03012061|141301778|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|0.79||0.309|TWO_SIDED|95.0|-0.7|2.3|||MMRM||UMEC 31.25 mcg vs Placebo, DBP, Week 4|||2.3|-0.7|0.309
70905985|NCT03012061|141301778|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.82||0.521|TWO_SIDED|95.0|-2.1|1.1|||MMRM||UMEC 31.25 mcg vs Placebo, DBP, Week 12|||1.1|-2.1|0.521
70905986|NCT03012061|141301778|SUPERIORITY||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|0.81||0.047|TWO_SIDED|95.0|0.0|3.2|||MMRM||UMEC 31.25 mcg vs Placebo, DBP, Week 24|||3.2|0.0|0.047
70905987|NCT03012061|141301778|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.78||0.779|TWO_SIDED|95.0|-1.3|1.8|||MMRM||UMEC 62.5 mcg versus placebo, DBP, Week 4|||1.8|-1.3|0.779
70905988|NCT03012061|141301778|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|0.82||0.204|TWO_SIDED|95.0|-0.6|2.6|||MMRM||UMEC 62.5 mcg versus placebo, DBP, Week 12|||2.6|-0.6|0.204
70905989|NCT03012061|141301778|SUPERIORITY||Mean Difference (Net)|1.5|STANDARD_ERROR_OF_MEAN|0.81||0.066|TWO_SIDED|95.0|-0.1|3.1|||MMRM||UMEC 62.5 mcg versus placebo, DBP, Week 24|||3.1|-0.1|0.066
70905990|NCT03012061|141301779|SUPERIORITY||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|0.97||0.195|TWO_SIDED|95.0|-0.7|3.2|||MMRM||UMEC 31.25 mcg vs Placebo, Week 4|||3.2|-0.7|0.195
70905991|NCT03012061|141301779|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.84||0.457|TWO_SIDED|95.0|-1.0|2.3|||MMRM||UMEC 31.25 mcg versus Placebo, Week 12|||2.3|-1.0|0.457
70905992|NCT03012061|141301779|SUPERIORITY||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|1.07||0.3|TWO_SIDED|95.0|-1.0|3.2|||MMRM||UMEC 31.25 mcg versus Placebo, Week 24|||3.2|-1.0|0.300
70905993|NCT03012061|141301779|SUPERIORITY||Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|0.97||0.14|TWO_SIDED|95.0|-0.5|3.3|||MMRM||UMEC 62.5 mcg versus Placebo, Week 4|||3.3|-0.5|0.140
70905994|NCT03012061|141301779|SUPERIORITY||Mean Difference (Net)|1.7|STANDARD_ERROR_OF_MEAN|0.84||0.045|TWO_SIDED|95.0|0.0|3.3|||MMRM||UMEC 62.5 mcg versus Placebo, Week 12|||3.3|0.0|0.045
70905995|NCT03012061|141301779|SUPERIORITY||Mean Difference (Net)|3.4|STANDARD_ERROR_OF_MEAN|1.07||0.002|TWO_SIDED|95.0|1.3|5.5|||MMRM||UMEC 62.5 mcg versus Placebo, Week 24|||5.5|1.3|0.002
70905996|NCT02696902|141301780|SUPERIORITY||Relative risk reduction|-23.7||||0.491|TWO_SIDED|80.0|-83.8|16.8|||Poisson regression with robust variance|||||16.8|-83.8|0.491
70905997|NCT02855164|141301807|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Parts A + B) (Full analysis set)|LS mean change|-15.9|STANDARD_ERROR_OF_MEAN|7.76||0.362|TWO_SIDED|95.0|-31.2|-0.6|||ANCOVA|||10 micrograms of Tropifexor vs placebo (Part A)||-0.6|-31.2|0.362
70905998|NCT02855164|141301807|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Parts A + B) (Full analysis set)|LS mean change|-10.7|STANDARD_ERROR_OF_MEAN|7.12||0.729|TWO_SIDED|95.0|-24.8|3.3|||ANCOVA|||30 micrograms of Tropifexor vs placebo (Part A)||3.3|-24.8|0.729
70905999|NCT02855164|141301807|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Parts A + B) (Full analysis set)|Least Square Mean Change|-16.5|STANDARD_ERROR_OF_MEAN|4.73||0.173|TWO_SIDED|95.0|-25.8|-7.1|||ANCOVA|||60 micrograms of Tropifexor vs placebo (Parts A + B)||-7.1|-25.8|0.173
70906000|NCT02855164|141301807|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Parts A + B) (Full analysis set)|Least Square Mean Change|-14.9|STANDARD_ERROR_OF_MEAN|3.25||0.185|TWO_SIDED|95.0|-21.3|-8.5|||ANCOVA|||90 micrograms of Tropifexor vs placebo (Parts A + B)||-8.5|-21.3|0.185
70906001|NCT02855164|141301807|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Part C) (Full analysis set)|LS Mean Change|-31.6|STANDARD_ERROR_OF_MEAN|7.71||0.02|TWO_SIDED|95.0|-46.9|-16.3|||ANCOVA|||140 micrograms of Tropifexor (Part C) vs placebo||-16.3|-46.9|0.020
70906002|NCT02855164|141301807|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Part C) (Full analysis set)|LS Mean Change|-32.5|STANDARD_ERROR_OF_MEAN|9.1||0.03|TWO_SIDED|95.0|-50.6|-14.5|||ANCOVA|||200 micrograms of Tropifexor vs placebo (Part C)||-14.5|-50.6|0.030
70906003|NCT02855164|141301807|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline to Week 12 (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-13.4|STANDARD_ERROR_OF_MEAN|7.86||0.456|TWO_SIDED|95.0|-26.3|-0.4|||ANCOVA|||10 micrograms of Tropifexor vs placebo (Parts A + B + C)||-0.4|-26.3|0.456
70906004|NCT02855164|141301807|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline to Week 12 (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-7.5|STANDARD_ERROR_OF_MEAN|7.27||0.966|TWO_SIDED|95.0|-19.5|4.4|||ANCOVA|||30 micrograms of Tropifexor vs placebo (Parts A + B + C)||4.4|-19.5|0.966
70906005|NCT02855164|141301807|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline to Week 12 (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-13.3|STANDARD_ERROR_OF_MEAN|4.93||0.275|TWO_SIDED|95.0|-21.4|-5.2|||ANCOVA|||60 micrograms of Tropifexor vs placebo (Parts A + B + C)||-5.2|-21.4|0.275
70906006|NCT02855164|141301807|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline to Week 12 (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-11.8|STANDARD_ERROR_OF_MEAN|3.56||0.304|TWO_SIDED|95.0|-17.6|-5.9|||ANCOVA|||90 micrograms of Tropifexor vs placebo (Parts A + B + C)||-5.9|-17.6|0.304
70906007|NCT02855164|141301807|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Parts A + B) FAS|LS Mean change|-17.1|STANDARD_ERROR_OF_MEAN|4.45||0.057|TWO_SIDED|95.0|-24.5|-9.8|||ANCOVA|||140 micrograms of Tropifexor vs placebo (Parts A + B + C)||-9.8|-24.5|0.057
70906008|NCT02855164|141301807|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Parts A + B + C) FAS|LS Mean change|-23.0|STANDARD_ERROR_OF_MEAN|4.49||0.003|TWO_SIDED|95.0|-30.5|-15.6|||ANCOVA|||200 micrograms of Tropifexor vs placebo (Parts A + B + C)||-15.6|-30.5|0.003
70906009|NCT02855164|141301808|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Full analysis set)|LS Mean change|-9.9|STANDARD_ERROR_OF_MEAN|6.56||0.722|TWO_SIDED|95.0|-22.9|3.0|||ANCOVA|||10 micrograms of Tropifexor vs placebo (Part A)||3.0|-22.9|0.722
70906010|NCT02855164|141301808|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Full analysis set)|LS Mean change|-2.2|STANDARD_ERROR_OF_MEAN|5.96||0.468|TWO_SIDED|95.0|-14.0|9.5|||ANCOVA|||30 micrograms of Tropifexor vs placebo (Part A)||9.5|-14.0|0.468
70906011|NCT02855164|141301808|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B) (Full analysis set)|LS Mean change|-8.8|STANDARD_ERROR_OF_MEAN|3.97||0.774|TWO_SIDED|95.0|-16.7|-1.0|||ANCOVA|||60 micrograms of Tropifexor vs placebo (Parts A+B)||-1.0|-16.7|0.774
70906012|NCT02855164|141301808|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B) (Full analysis set)|LS Mean change|-0.6|STANDARD_ERROR_OF_MEAN|2.76||0.136|TWO_SIDED|95.0|-6.0|4.9|||ANCOVA|||90 micrograms of Tropifexor vs placebo (Parts A+B)||4.9|-6.0|0.136
70906013|NCT02855164|141301808|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Part C) (Full analysis set)|LS Mean change|-16.0|STANDARD_ERROR_OF_MEAN|3.97||0.145|TWO_SIDED|95.0|-23.9|-8.2|||ANCOVA|||140 micrograms of Tropifexor vs placebo (Part C)||-8.2|-23.9|0.145
70906014|NCT02855164|141301808|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Part C) (Full analysis set)|LS Mean change|-15.3|STANDARD_ERROR_OF_MEAN|4.49||0.236|TWO_SIDED|95.0|-24.2|-6.4|||ANCOVA|||200 micrograms of Tropifexor vs placebo (Part C)||-6.4|-24.2|0.236
70906015|NCT02855164|141301808|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-7.1|STANDARD_ERROR_OF_MEAN|7.0||0.788|TWO_SIDED|95.0|-18.7|4.4|||ANCOVA|||10 micrograms of Tropifexor vs placebo (Parts A+B+ C)||4.4|-18.7|0.788
70906016|NCT02855164|141301808|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B+C) Full analysis set (FAS)|LS Mean change|0.4|STANDARD_ERROR_OF_MEAN|6.43||0.413|TWO_SIDED|95.0|-10.2|11.0|||ANCOVA|||30 micrograms of Tropifexor vs placebo (Parts A+B+ C)||11.0|-10.2|0.413
70906017|NCT02855164|141301808|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-6.2|STANDARD_ERROR_OF_MEAN|4.38||0.833|TWO_SIDED|95.0|-13.4|1.0|||ANCOVA|||60 micrograms of Tropifexor vs placebo (Parts A+B+ C)||1.0|-13.4|0.833
70906018|NCT02855164|141301808|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B+C) Full analysis set (FAS)|LS Mean change|2.0|STANDARD_ERROR_OF_MEAN|3.19||0.068|TWO_SIDED|95.0|-3.2|7.3|||ANCOVA|||90 micrograms of Tropifexor vs placebo (Parts A+B+ C)||7.3|-3.2|0.068
70906019|NCT02855164|141301808|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-0.1|STANDARD_ERROR_OF_MEAN|3.98||0.269|TWO_SIDED|95.0|-6.6|6.5|||ANCOVA|||140 micrograms of Tropifexor vs placebo (Parts A+B+ C)||6.5|-6.6|0.269
70906020|NCT02855164|141301808|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-3.8|STANDARD_ERROR_OF_MEAN|4.05||0.777|TWO_SIDED|95.0|-10.5|2.9|||ANCOVA|||200 micrograms of Tropifexor vs placebo (Parts A+B+ C)||2.9|-10.5|0.777
70906021|NCT02855164|141301809|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12|LS Mean change|-7.48|STANDARD_ERROR_OF_MEAN|6.174||0.853|TWO_SIDED|95.0|-19.66|4.7|||ANCOVA|||10 microgramsof Tropifexor - Change in percentage of fat in the liver Part A||4.70|-19.66|0.853
70906022|NCT02855164|141301809|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12|LS Mean change|-14.07|STANDARD_ERROR_OF_MEAN|5.661||0.232|TWO_SIDED|95.0|-25.24|-2.91|||ANCOVA|||30 micrograms of Tropifexor - Change in percentage of fat in the liver Part A||-2.91|-25.24|0.232
70906023|NCT02855164|141301809|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12|LS Mean change|-15.04|STANDARD_ERROR_OF_MEAN|3.754||0.077|TWO_SIDED|95.0|-22.45|-7.64|||ANCOVA|||60 micrograms of Tropifexor - Change in percentage of fat in the liver Parts A+B||-7.64|-22.45|0.077
70906024|NCT02855164|141301809|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline|LS Mean change|-12.34|STANDARD_ERROR_OF_MEAN|2.482||0.141|TWO_SIDED|95.0|-17.23|-7.44|||ANCOVA|||90 micrograms of Tropifexor - Change in percentage of fat in the liver Parts A+B||-7.44|-17.23|0.141
70906025|NCT02855164|141301809|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12|LS Mean change|-31.25|STANDARD_ERROR_OF_MEAN|5.228|<|0.001|TWO_SIDED|95.0|-41.58|-20.92|||ANCOVA|||140 micrograms of Tropifexor - Change in percentage of fat in the liver Part C||-20.92|-41.58|<0.001
70906026|NCT02855164|141301809|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-39.54|STANDARD_ERROR_OF_MEAN|4.968|<|0.001|TWO_SIDED|95.0|-49.37|-29.71|||ANCOVA|||200 micrograms of Tropifexor - Change in percentage of fat in the liver Part C||-29.71|-49.37|<0.001
70906027|NCT02855164|141301809|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-8.09|STANDARD_ERROR_OF_MEAN|6.65||0.872|TWO_SIDED|95.0|-19.06|2.88|||ANCOVA|||10 micrograms of Tropifexor - Change in percentage of fat in the liver Parts A+B+C||2.88|-19.06|0.872
70906028|NCT02855164|141301809|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-14.14|STANDARD_ERROR_OF_MEAN|6.198||0.465|TWO_SIDED|95.0|-24.36|-3.91|||ANCOVA|||30 micrograms of Tropifexor - Change in percentage of fat in the liver Parts A+B+C||-3.91|-24.36|0.465
70906029|NCT02855164|141301809|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-15.02|STANDARD_ERROR_OF_MEAN|4.078||0.228|TWO_SIDED|95.0|-21.75|-8.29|||ANCOVA|||60 micrograms of Tropifexor - Change in percentage of fat in the liver Parts A+B+C||-8.29|-21.75|0.228
70906030|NCT02855164|141301809|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-12.56|STANDARD_ERROR_OF_MEAN|2.717||0.37|TWO_SIDED|95.0|-17.04|-8.08|||ANCOVA|||90 micrograms - Change in percentage of fat in the liver Parts A+B+C||-8.08|-17.04|0.370
70906031|NCT02855164|141301809|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-18.71|STANDARD_ERROR_OF_MEAN|3.517||0.029|TWO_SIDED|95.0|-24.51|-12.91|||ANCOVA|||140 micrograms - Change in percentage of fat in the liver Parts A+B+C||-12.91|-24.51|0.029
70906032|NCT02855164|141301809|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-34.38|STANDARD_ERROR_OF_MEAN|3.482|<|0.001|TWO_SIDED|95.0|-40.13|-28.64|||ANCOVA|||200 micrograms of Tropifexor - Change in percentage of fat in the liver Parts A+B+C||-28.64|-40.13|<0.001
70906033|NCT02855164|141301810|SUPERIORITY|Repeated measures analysis: Change in weight from baseline to EOT (Parts A + B) (Full analysis set)|LS Mean change|-1.79|STANDARD_ERROR_OF_MEAN|0.608||0.01|TWO_SIDED|95.0|-2.99|0.59|||Mixed Models Analysis|||10 micrograms of Tropifexor (Part A) vs Placebo||0.59|-2.99|0.010
70906034|NCT02855164|141301810|SUPERIORITY|Repeated measures analysis: Change in weight from baseline to EOT (Parts A + B) (Full analysis set)|LS Mean change|-0.78|STANDARD_ERROR_OF_MEAN|0.567||0.237|TWO_SIDED|95.0|-1.9|0.34|||Mixed Models Analysis|||30 micrograms of Tropifexor (Part A) vs Placebo||0.34|-1.90|0.237
70906035|NCT02855164|141301810|SUPERIORITY|Repeated measures analysis: Change in weight from baseline to EOT (Parts A + B) (Full analysis set)|LS Mean change|-1.05|STANDARD_ERROR_OF_MEAN|0.377||0.037|TWO_SIDED|95.0|-1.8|0.31|||Mixed Models Analysis|||60 micrograms of Tropifexor (Parts A + B) vs Placebo||0.31|-1.80|0.037
70906036|NCT02855164|141301810|SUPERIORITY|Repeated measures analysis: Change in weight from baseline to EOT (Parts A + B) (Full analysis set)|LS Mean change|-1.15|STANDARD_ERROR_OF_MEAN|0.253||0.007|TWO_SIDED|95.0|-1.65|0.65|||Mixed Models Analysis|||90 micrograms of Tropifexor (Parts A + B) vs Placebo||0.65|-1.65|0.007
70906037|NCT02855164|141301810|SUPERIORITY|Repeated measures analysis: Change in weight from baseline to EOT (Parts C) (Full analysis set)|LS Mean change|-5.1|STANDARD_ERROR_OF_MEAN|0.988||0.053|TWO_SIDED|95.0|-7.05|-3.14|||Mixed Models Analysis|||140 micrograms of Tropifexor (Part C) vs Placebo||-3.14|-7.05|0.053
70906038|NCT02855164|141301810|SUPERIORITY|Repeated measures analysis: Change in weight from baseline to EOT (Parts C) (Full analysis set)|LS Mean change|-5.89|STANDARD_ERROR_OF_MEAN|1.002||0.013|TWO_SIDED|95.0|-7.87|-3.91|||Mixed Models Analysis|||200 micrograms of Tropifexor (Part C) vs Placebo||-3.91|-7.87|0.013
70906039|NCT02855164|141301811|SUPERIORITY|Repeated measures analysis: Change in BMI from baseline to EOT (Full analysis set)|LS Mean change|-0.64|STANDARD_ERROR_OF_MEAN|0.208||0.006|TWO_SIDED|95.0|-1.05|0.23|||Mixed Models Analysis|||10 micrograms of Tropifexor (Part A) vs Placebo||0.23|-1.05|0.006
70906040|NCT02855164|141301811|SUPERIORITY|Repeated measures analysis: Change in BMI from baseline to EOT (Full analysis set)|LS Mean change|-0.29|STANDARD_ERROR_OF_MEAN|0.194||0.177|TWO_SIDED|95.0|-0.67|0.09|||Mixed Models Analysis|||30 micrograms of Tropifexor (Part A) vs Placebo||0.09|-0.67|0.177
70906041|NCT02855164|141301811|SUPERIORITY|Repeated measures analysis: Change in BMI from baseline to EOT (Parts C) (Full analysis set)|LS Mean change|-0.35|STANDARD_ERROR_OF_MEAN|0.129||0.032|TWO_SIDED|95.0|-0.61|0.1|||Mixed Models Analysis|||60 micrograms of Tropifexor (Parts A + B) vs Placebo||0.10|-0.61|0.032
70906042|NCT02855164|141301811|SUPERIORITY|Repeated measures analysis: Change in BMI from baseline to EOT (Full analysis set)|LS Mean change|-0.42|STANDARD_ERROR_OF_MEAN|0.087||0.003|TWO_SIDED|95.0|-0.59|0.25|||Mixed Models Analysis|||90 micrograms of Tropifexor (Parts A + B) vs Placebo||0.25|-0.59|0.003
70906043|NCT02855164|141301811|SUPERIORITY|Repeated measures analysis: Change in BMI from baseline to EOT (Full analysis set)|LS Mean change|-1.88|STANDARD_ERROR_OF_MEAN|0.322||0.015|TWO_SIDED|95.0|-2.51|-1.24|||Mixed Models Analysis|||140 micrograms of Tropifexor (Part C) vs Placebo||-1.24|-2.51|0.015
70906044|NCT02855164|141301811|SUPERIORITY|Repeated measures analysis: Change in BMI from baseline to EOT (Parts C) (Full analysis set)|LS Mean change|-2.11|STANDARD_ERROR_OF_MEAN|0.327||0.004|TWO_SIDED|95.0|-2.75|-1.46|||Mixed Models Analysis|||200 micrograms of Tropifexor (Part C) vs Placebo||-1.46|-2.75|0.004
70906045|NCT02855164|141301812|SUPERIORITY|Repeated measures analysis: Change in WTH ratio from baseline to EOT (Parts A+B) (Full analysis set)|LS Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.009||0.53|TWO_SIDED|95.0|-0.03|0.01|||Mixed Models Analysis|||10 micrograms of Tropifexor (Part A) vs Placebo||0.01|-0.03|0.530
70906046|NCT02855164|141301812|SUPERIORITY|Repeated measures analysis: Change in WTH ratio from baseline to EOT (Parts A+B) (Full analysis set)|LS Mean change|0.0|STANDARD_ERROR_OF_MEAN|0.008||0.857|TWO_SIDED|95.0|-0.02|0.01|||Mixed Models Analysis|||30 micrograms of Tropifexor (Part A) vs Placebo||0.01|-0.02|0.857
70906047|NCT02855164|141301812|SUPERIORITY|Repeated measures analysis: Change in WTH ratio from baseline to EOT (Parts A+B) (Full analysis set)|LS Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.005||0.262|TWO_SIDED|95.0|-0.02|0.0|||Mixed Models Analysis|||60 micrograms of Tropifexor (Part A) vs Placebo||0.00|-0.02|0.262
70906048|NCT02855164|141301812|SUPERIORITY|Repeated measures analysis: Change in WTH ratio from baseline to EOT (Parts A+B) (Full analysis set)|LS Mean change|0.0|STANDARD_ERROR_OF_MEAN|0.004||0.323|TWO_SIDED|95.0|0.0|0.01|||Mixed Models Analysis|||90 micrograms of Tropifexor (Parts A + B) vs Placebo||0.01|0.00|0.323
70906049|NCT02855164|141301812|SUPERIORITY|Repeated measures analysis: Change in WTH ratio from baseline to EOT (Part C) (Full analysis set)|LS Mean change|0.01|STANDARD_ERROR_OF_MEAN|0.008||0.1|TWO_SIDED|95.0|-0.02|0.01|||Mixed Models Analysis|||140 micrograms of Tropifexor (Part C) vs Placebo||0.01|-0.02|0.100
70906050|NCT02855164|141301812|SUPERIORITY|Repeated measures analysis: Change in WTH ratio from baseline to EOT (Part C) (Full analysis set)|LS Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.007||0.693|TWO_SIDED|95.0|-0.03|0.0|||Mixed Models Analysis|||200 micrograms of Tropifexor (Part C) vs Placebo||0.00|-0.03|0.693
70906051|NCT02855164|141301824|SUPERIORITY||Risk Difference (RD)|0.004||||1|TWO_SIDED|95.0|-0.214|0.223|||Mixed Models Analysis|||At least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (total score)||0.223|-0.214|1.0000
70906052|NCT02855164|141301824|SUPERIORITY||Risk Difference (RD)|0.029||||0.8074|TWO_SIDED|95.0|-0.196|0.251|||Mixed Models Analysis|||At least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (total score)||0.251|-0.196|0.8074
70906053|NCT02855164|141301825|SUPERIORITY||Risk Difference (RD)|0.028||||0.807|TWO_SIDED|95.0|-0.191|0.246|||Mixed Models Analysis|||At least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (FDA)||0.246|-0.191|0.8070
70906054|NCT02855164|141301825|SUPERIORITY||Risk Difference (RD)|0.052||||0.6233|TWO_SIDED|95.0|-0.173|0.273|||Mixed Models Analysis|||At least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (FDA)||0.273|-0.173|0.6233
70906055|NCT02855164|141301826|SUPERIORITY||Risk Difference (RD)|0.004||||1|TWO_SIDED|95.0|-0.214|0.233|||Mixed Models Analysis|||At least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (EMA)||0.233|-0.214|1.0000
70906056|NCT02855164|141301826|SUPERIORITY||Risk Difference (RD)|0.029||||0.8074|TWO_SIDED|95.0|-0.196|0.251|||Mixed Models Analysis|||At least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (EMA)||0.251|-0.196|0.8074
70906057|NCT02855164|141301827|SUPERIORITY||Risk Difference (RD)|0.034||||0.7028|TWO_SIDED|95.0|-0.184|0.252|||Mixed Models Analysis|||Resolution of steatohepatitis (diagnostic category) without worsening of fibrosis (NASH CRN staging)||0.252|-0.184|0.7028
70906058|NCT02855164|141301827|SUPERIORITY||Risk Difference (RD)|0.129||||0.1713|TWO_SIDED|95.0|-0.098|0.345|||Mixed Models Analysis|||Resolution of steatohepatitis (diagnostic category) without worsening of fibrosis (NASH CRN staging)||0.345|-0.098|0.1713
70906059|NCT02855164|141301828|SUPERIORITY||Risk Difference (RD)|0.057||||0.2033|TWO_SIDED|95.0|-0.168|0.278|||Mixed Models Analysis|||Resolution of steatohepatitis (FDA, EMA) without worsening of fibrosis (NASH CRN staging)||0.278|-0.168|0.2033
70906060|NCT00383240|141301829|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
70906061|NCT00383240|141301829|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
70906062|NCT00383240|141301829|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
70906063|NCT00383240|141301829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.491||95.0||||P-Value for Endpoint|ANCOVA|||||||0.491
70906064|NCT00383240|141301829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.055||95.0||||P-Value for Endpoint|ANCOVA|||||||0.055
70906065|NCT00383240|141301829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||P-Value for Endpoint|ANCOVA|||||||0.008
70906066|NCT00383240|141301830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.174||95.0||||P-Value for Endpoint|ANCOVA|||||||0.174
70906067|NCT00383240|141301830|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
70906068|NCT00383240|141301830|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
70906069|NCT00383240|141301830|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
70906070|NCT00383240|141301830|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
70906071|NCT00383240|141301830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.521||95.0||||P-Value for Endpoint|ANCOVA|||||||0.521
70906072|NCT00383240|141301832|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026||95.0||||P-Value for Endpoint|ANCOVA|||||||0.026
70906073|NCT00383240|141301832|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
70906074|NCT00383240|141301832|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
70906075|NCT00383240|141301832|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
70906076|NCT00383240|141301832|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
70906077|NCT00383240|141301832|SUPERIORITY_OR_OTHER_LEGACY|||||||0.738||95.0||||P-Value for Endpoint|ANCOVA|||||||0.738
70906078|NCT00383240|141301833|SUPERIORITY_OR_OTHER_LEGACY|||||||0.063||95.0||||P-Value for endpoint|ANCOVA|||||||0.063
70906079|NCT00383240|141301833|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
70906080|NCT00383240|141301833|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
70906081|NCT00383240|141301833|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
70906082|NCT00383240|141301833|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||P-Value for Endpoint|ANCOVA|||||||0.003
70906083|NCT00383240|141301833|SUPERIORITY_OR_OTHER_LEGACY|||||||0.601||95.0||||P-Value for Endpoint|ANCOVA|||||||0.601
70906084|NCT03918239|141301846|OTHER|Analysis was performed for estimation of least square means only. Descriptive statistical analysis was the main analysis.|Ratio of Geometric least squares Means|1.079|||||TWO_SIDED|90.0|0.986|1.181|||ANOVA|||An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and treatment group as a fixed effect variable.||1.181|0.986|
70906085|NCT03918239|141301847|OTHER|Analysis was performed for estimation of least square means only. Descriptive statistical analysis was the main analysis.|Ratio of Geometric least squares Means|1.079|||||TWO_SIDED|90.0|0.987|1.179||||||An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and treatment group as a fixed effect variable.||1.179|0.987|
70906086|NCT03918239|141301848|OTHER|Analysis was performed for estimation of least square means only. Descriptive statistical analysis was the main analysis.|Ratio of Geometric least squares Means|1.157|||||TWO_SIDED|90.0|1.044|1.281||||||An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and treatment group as a fixed effect variable.||1.281|1.044|
70906087|NCT04249336|141301866|SUPERIORITY||Mean Difference (Net)|36.0|||<|0.05|TWO_SIDED|95.0||||Threshold for statistical significance was p \<0.05.|ANOVA||Treatment difference in percent = BioMin F- Colgate Total|It was calculated that 140 participants randomized in a 1:1:1:1 fashion between the four arms would have at least 80 % power to detect a difference of 0.20 mean scores between four treatments from baseline to week 4. Sample size was determined using PAS V.11, two independent sample t-test with 95% confidence interval.||||<0.05
70906088|NCT04249336|141301866|SUPERIORITY||Mean Difference (Net)|33.0|||<|0.05|TWO_SIDED|95.0||||Threshold P\<0.05|ANOVA||Treatment difference in percent = Colgate Sensitive Pro relief - Colgate Total|||||<0.05
70906089|NCT04249336|141301866|SUPERIORITY||Mean Difference (Net)|23.0|||<|0.05|TWO_SIDED|95.0||||Threshold for statistical significance was p \<0.05.|ANOVA||Treatment difference in percent = Sensodyne Rapid Action - Colgate Total|||||<0.05
70906090|NCT04249336|141301867|SUPERIORITY||Mean Difference (Net)|32.0|||<|0.05|TWO_SIDED|95.0||||Threshold for statistical significance was p \<0.05.|ANCOVA||Treatment difference in percent = BioMin F- Colgate Total|It was calculated that 140 participants randomized in a 1:1:1:1 fashion between the four arms would have at least 80 % power to detect a difference of 0.20 mean scores between four treatments from baseline to week 4. Sample size was determined using PAS V.11, two independent sample t-test with 95% confidence interval.||||<0.05
70906091|NCT04249336|141301867|SUPERIORITY||Mean Difference (Net)|39.0|||<|0.05|TWO_SIDED|||||Threshold for statistical significance was p \<0.05.|ANOVA||Treatment difference in percent = Colgate Sensitive Pro relief - Colgate Total|||||<0.05
70906092|NCT04249336|141301867|SUPERIORITY||Mean Difference (Net)|30.0|||<|0.05|TWO_SIDED|||||Threshold for statistical significance was p \<0.05.|ANOVA||Treatment difference in percent = Sensodyne Rapid Action - Colgate Total|||||<0.05
70906093|NCT04249336|141301868|SUPERIORITY||Median Difference (Net)|36.0|||<|0.05|TWO_SIDED|95.0||||Threshold for statistical significance was p \<0.05.|ANCOVA||Treatment difference in percent = BioMin F- Colgate Total|It was calculated that 140 participants randomized in a 1:1:1:1 fashion between the four arms would have at least 80 % power to detect a difference of 0.20 mean scores between four treatments from baseline to week 4. Sample size was determined using PAS V.11, two independent sample t-test with 95% confidence interval.||||<0.05
70906094|NCT04249336|141301868|SUPERIORITY||Mean Difference (Net)|28.0|||<|0.05|TWO_SIDED|95.0||||Threshold for statistical significance was p \<0.05.|ANOVA||Treatment difference in percent = Colgate Sensitive Pro relief - Colgate Total|||||<0.05
70906095|NCT04249336|141301868|SUPERIORITY||Mean Difference (Net)|25.0|||<|0.05|TWO_SIDED|95.0||||Threshold for statistical significance was p \<0.05.|ANOVA||Treatment difference in percent = Sensodyne Rapid Action - Colgate Total|||||<0.05
70906096|NCT03390036|141301873|SUPERIORITY|||||||0.8106|||||||ANOVA|||||||0.8106
70906097|NCT03390036|141301874|SUPERIORITY|||||||0.3007|||||||ANOVA|||||||0.3007
70906098|NCT03390036|141301875|SUPERIORITY|||||||0.6354|||||||ANOVA|||||||0.6354
70906099|NCT03390036|141301876|SUPERIORITY|||||||0.5754|||||||ANOVA|||||||0.5754
70906100|NCT03390036|141301877|SUPERIORITY|||||||0.4759|||||||ANOVA|||||||0.4759
70906101|NCT03390036|141301878|SUPERIORITY|||||||0.5596|||||||ANOVA|||||||0.5596
70906102|NCT03390036|141301879|SUPERIORITY|||||||0.4551|||||||ANOVA|||||||0.4551
70906103|NCT03390036|141301880|SUPERIORITY|||||||0.7931|||||||ANOVA|||||||0.7931
70906104|NCT00358215|141301881|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.871|TWO_SIDED|95.0|0.9|1.13||Stratification factors are: region and type of device (cardiac resynchronization therapy (CRT) with or without implantable cardioverter defibrillator (ICD), ICD without CRT, or none)|Stratified Log Rank||The hazard ratio and 95% confidence intervals are from the Cox proportional hazards model adjusted by the stratification factors.|||1.13|0.90|0.871
70906105|NCT00358215|141301882|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04||||0.512|TWO_SIDED|95.0|0.92|1.19||Stratification factors are: region and type of device (cardiac resynchronization therapy (CRT) with or without implantable cardioverter defibrillator (ICD), ICD without CRT, or none).|Stratified Log Rank||The hazard ratio and 95% confidence intervals are from the Cox proportional hazards model adjusted by the stratification factors.|||1.19|0.92|0.512
70906106|NCT00358215|141301883|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.922|TWO_SIDED|95.0|0.89|1.14||Stratification factors are: region and type of device (cardiac resynchronization therapy (CRT) with or without implantable cardioverter defibrillator (ICD), ICD without CRT, or none).|Stratified Log Rank||The hazard ratio and 95% confidence intervals are from the Cox proportional hazards model adjusted by the stratification factors.|||1.14|0.89|0.922
70906107|NCT00358215|141301884|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|2.2|STANDARD_ERROR_OF_MEAN|0.79||0.005|TWO_SIDED|95.0|0.65|3.75|||Mixed Models Analysis|Mixed effects model estimating treatment effect adjusted for region, type of device, and Baseline KCCQ score.||||3.75|0.65|0.005
70906108|NCT00358215|141301885|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|2.29|STANDARD_ERROR_OF_MEAN|0.9||0.011|TWO_SIDED|95.0|0.53|4.05|||Mixed Models Analysis|Mixed effects model estimating treatment effect adjusted for region, type of device, and Baseline KCCQ score.||||4.05|0.53|0.011
70906109|NCT01169259|141301911|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.88|1.06|||Regression, Cox|||||1.06|0.88|
70906110|NCT01169259|141301911|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.93|1.13|||Regression, Cox|||||1.13|0.93|
70906111|NCT01169259|141301912|SUPERIORITY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.85|1.12|||Regression, Cox|||||1.12|0.85|
70906112|NCT01169259|141301912|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.8|1.06|||Regression, Cox|||||1.06|0.80|
70906113|NCT01169259|141301913|SUPERIORITY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.67|1.02|||Regression, Cox|||||1.02|0.67|
70906114|NCT01169259|141301913|SUPERIORITY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.79|1.2|||Regression, Cox|||||1.20|0.79|
70906115|NCT01169259|141301914|SUPERIORITY||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.79|1.31|||Regression, Cox|||||1.31|0.79|
70906116|NCT01169259|141301914|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.7|1.16|||Regression, Cox|||||1.16|0.70|
70906117|NCT01169259|141301915|SUPERIORITY||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.72|1.07|||Regression, Cox|||||1.07|0.72|
70906118|NCT01169259|141301915|SUPERIORITY||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.94|1.39|||Regression, Cox|||||1.39|0.94|
70906119|NCT01169259|141301916|SUPERIORITY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.73|1.62|||Regression, Cox|||||1.62|0.73|
70906120|NCT01169259|141301916|SUPERIORITY||Hazard Ratio (HR)|1.23|||||TWO_SIDED|95.0|0.83|1.83|||Regression, Cox|||||1.83|0.83|
70906121|NCT01169259|141301917|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.86|1.08|||Regression, Cox|||||1.08|0.86|
70906122|NCT01169259|141301917|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.82|1.04|||Regression, Cox|||||1.04|0.82|
70906123|NCT01169259|141301918|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.78|1.19|||Regression, Cox|||||1.19|0.78|
70906124|NCT01169259|141301918|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.59|0.9|||Regression, Cox|||||0.90|0.59|
70906125|NCT01169259|141301919|SUPERIORITY||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.76|1.2|||Regression, Cox|||||1.20|0.76|
70906126|NCT01169259|141301919|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.83|1.31|||Regression, Cox|||||1.31|0.83|
70906127|NCT01169259|141301920|SUPERIORITY||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.88|1.4|||Regression, Cox|||||1.40|0.88|
70906128|NCT01169259|141301920|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.76|1.21|||Regression, Cox|||||1.21|0.76|
70906129|NCT01169259|141301921|SUPERIORITY||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.87|1.12|||Regression, Cox|||||1.12|0.87|
70906130|NCT01169259|141301921|SUPERIORITY||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.9|1.15|||Regression, Cox|||||1.15|0.90|
70906131|NCT01169259|141301922|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.83|1.06|||Regression, Cox|||||1.06|0.83|
70906132|NCT01169259|141301922|SUPERIORITY||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|1.0|1.28|||Regression, Cox|||||1.28|1.00|
70906133|NCT01169259|141301923|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.79|1.09|||Regression, Cox|||||1.09|0.79|
70906134|NCT01169259|141301923|SUPERIORITY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.76|1.05|||Regression, Cox|||||1.05|0.76|
70906135|NCT01169259|141301924|SUPERIORITY||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.59|0.96|||Regression, Cox|||||0.96|0.59|
70906136|NCT01169259|141301924|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.73|1.19|||Regression, Cox|||||1.19|0.73|
70906137|NCT01169259|141301925|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.84|1.11|||Regression, Cox|||||1.11|0.84|
70906138|NCT01169259|141301925|SUPERIORITY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.84|1.12|||Regression, Cox|||||1.12|0.84|
70906139|NCT01169259|141301926|SUPERIORITY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.79|1.19|||Regression, Cox|||||1.19|0.79|
70906140|NCT01169259|141301926|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.63|0.95|||Regression, Cox|||||0.95|0.63|
70906141|NCT01169259|141301927|SUPERIORITY||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.55|1.01|||Regression, Cox|||||1.01|0.55|
70906142|NCT01169259|141301927|SUPERIORITY||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.73|1.33|||Regression, Cox|||||1.33|0.73|
70906143|NCT01169259|141301928|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.83|1.12|||Regression, Cox|||||1.12|0.83|
70906144|NCT01169259|141301928|SUPERIORITY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.71|0.97|||Regression, Cox|||||0.97|0.71|
70906145|NCT01169259|141301929|SUPERIORITY||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.83|1.39|||Regression, Cox|||||1.39|0.83|
70906146|NCT01169259|141301929|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.74|1.24|||Regression, Cox|||||1.24|0.74|
70906147|NCT01169259|141301930|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.42|1.38|||Regression, Cox|||||1.38|0.42|
70906148|NCT01169259|141301930|SUPERIORITY||Hazard Ratio (HR)|1.32|||||TWO_SIDED|95.0|0.72|2.39|||Regression, Cox|||||2.39|0.72|
70906149|NCT01169259|141301931|SUPERIORITY||Hazard Ratio (HR)|1.6|||||TWO_SIDED|95.0|0.84|3.06|||Regression, Cox|||||3.06|0.84|
70906150|NCT01169259|141301931|SUPERIORITY||Hazard Ratio (HR)|0.5|||||TWO_SIDED|95.0|0.26|0.97|||Regression, Cox|||||0.97|0.26|
70906151|NCT01169259|141301932|SUPERIORITY||Hazard Ratio (HR)|1.27|||||TWO_SIDED|95.0|0.83|1.95|||Regression, Cox|||||1.95|0.83|
70906152|NCT01169259|141301932|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.49|1.16|||Regression, Cox|||||1.16|0.49|
70906153|NCT01169259|141301933|SUPERIORITY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.46|1.54|||Regression, Cox|||||1.54|0.46|
70906154|NCT01169259|141301933|SUPERIORITY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.6|2.01|||Regression, Cox|||||2.01|0.60|
70906155|NCT01169259|141301934|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.71|1.2|||Regression, Cox|||||1.20|0.71|
70906156|NCT01169259|141301934|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.55|0.93|||Regression, Cox|||||0.93|0.55|
70906157|NCT01169259|141301935|SUPERIORITY||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.92|1.27||||||||1.27|0.92|
70906158|NCT01169259|141301935|SUPERIORITY||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.83|1.15||||||||1.15|0.83|
70906159|NCT01169259|141301936|SUPERIORITY||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.82|1.26||||||||1.26|0.82|
70906160|NCT01169259|141301936|SUPERIORITY||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.84|1.29||||||||1.29|0.84|
70906161|NCT01017120|141301943|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for ILs|ANCOVA|||||||<0.001
70906162|NCT01017120|141301943|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for NILs|ANCOVA|||||||<0.001
70906163|NCT01017120|141301943|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for TLs|ANCOVA|||||||<0.001
70906164|NCT01017120|141301944|SUPERIORITY_OR_OTHER||Percentage of participants|32.2|||<|0.001|TWO_SIDED|95.0|27.4|36.9|||Cochran-Mantel-Haenszel||The estimated value represents the percentage of participants receiving tazarotene foam with a minimum 2 G improvement in the ISGA score from Baseline at Week 12.|||36.9|27.4|<0.001
70906165|NCT01017120|141301944|SUPERIORITY_OR_OTHER||Percentage of participants|18.2|||||TWO_SIDED|95.0|14.2|22.1|||||The estimated value represents the percentage of participants receiving vehicle foam with a minimum 2 G improvement in the ISGA score from Baseline at Week 12.|||22.1|14.2|
70906166|NCT01017120|141301945|SUPERIORITY_OR_OTHER||Percentage of participants|27.6|||<|0.001|TWO_SIDED|95.0|23.1|32.2|||Cochran-Mantel-Haenszel||The estimated value represents the percentage of participants receiving tazarotene foam with an ISGA score of 0 or 1 at Week 12.|||32.2|23.1|<0.001
70906167|NCT01017120|141301945|SUPERIORITY_OR_OTHER||Percentage of participants|13.3|||||TWO_SIDED|95.0|9.8|16.7|||||The estimated value represents the percentage of participants receiving vehicle foam with an ISGA score of 0 or 1 at Week 12.|||16.7|9.8|
70906168|NCT01087723|141301970|SUPERIORITY_OR_OTHER||Relative risk|0.6||||0.0014|TWO_SIDED|95.0|0.43|0.82|||Chi-squared|||||0.82|0.43|0.0014
70906169|NCT00252590|141301979|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||ANOVA|||||||0.32
70906170|NCT01702428|141301990|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% confidence interval (CI) on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to measles virus.|Difference in seroresponse rate|-0.54|||||TWO_SIDED|95.0|-1.69|0.58|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L1 Group minus INV\_MMR\_L2 Group) in percentage of subjects with anti-measles antibody concentration ≥200 mIU/mL.||0.58|-1.69|
70906171|NCT01702428|141301990|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% confidence interval (CI) on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to measles virus.|Difference in seroresponse rate|0.79|||||TWO_SIDED|95.0|-0.35|1.98|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L2 Group minus INV\_MMR\_L3 Group) in percentage of subjects with anti-measles antibody concentration ≥200 mIU/mL.||1.98|-0.35|
70906172|NCT01702428|141301990|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% confidence interval (CI) on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to measles virus.|Difference in seroresponse rate|0.25|||||TWO_SIDED|95.0|-0.98|1.5|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L1 Group minus INV\_MMR\_L3 Group) in percentage of subjects with anti-measles antibody concentration ≥200 mIU/mL.||1.50|-0.98|
70906173|NCT01702428|141301991|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|0.99|||||TWO_SIDED|95.0|0.91|1.06|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L1 Group divided by INV\_MMR\_L2 Group) for antibodies to measles virus at Day 42.||1.06|0.91|
70906174|NCT01702428|141301991|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|0.97|||||TWO_SIDED|95.0|0.9|1.05|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L1 Group divided by INV\_MMR\_L3 Group) for antibodies to measles virus at Day 42.||1.05|0.90|
70906175|NCT01702428|141301991|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.01|||||TWO_SIDED|95.0|0.94|1.09|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L2 Group divided by INV\_MMR\_L1 Group) for antibodies to measles virus at Day 42.||1.09|0.94|
70906176|NCT01702428|141301991|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|0.99|||||TWO_SIDED|95.0|0.91|1.06|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L2 Group divided by INV\_MMR\_L3 Group) for antibodies to measles virus at Day 42.||1.06|0.91|
70906177|NCT01702428|141301991|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.03|||||TWO_SIDED|95.0|0.95|1.11|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L3 Group divided by INV\_MMR\_L1 Group) for antibodies to measles virus at Day 42.||1.11|0.95|
70906178|NCT01702428|141301991|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.01|||||TWO_SIDED|95.0|0.94|1.09|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L3 Group divided by INV\_MMR\_L2 Group) for antibodies to measles virus at Day 42.||1.09|0.94|
70906179|NCT01702428|141301992|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to mumps virus.|Difference in seroresponse rate|0.02|||||TWO_SIDED|95.0|-1.05|1.09|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L1 Group minus INV\_MMR\_L2 Group) in percentage of subjects with anti-mumps antibody concentration ≥10 EU/mL.||1.09|-1.05|
70906180|NCT01702428|141301992|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to mumps virus.|Difference in seroresponse rate|0.63|||||TWO_SIDED|95.0|-0.5|1.81|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L1 Group minus INV\_MMR\_L3 Group) in percentage of subjects with anti-mumps antibody concentration ≥10 EU/mL.||1.81|-0.50|
70906181|NCT01702428|141301992|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to mumps virus.|Difference in seroresponse rate|0.61|||||TWO_SIDED|95.0|-0.53|1.79|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L2 Group minus INV\_MMR\_L3 Group) in percentage of subjects with anti-mumps antibody concentration ≥10 EU/mL.||1.79|-0.53|
70906182|NCT01702428|141301993|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to mumps.|Adjusted GMC ratio|0.93|||||TWO_SIDED|95.0|0.87|1.0|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L1 Group divided by INV\_MMR\_L2 Group) for antibodies to mumps virus at Day 42.||1.00|0.87|
70906183|NCT01702428|141301993|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to mumps.|Adjusted GMC ratio|1.04|||||TWO_SIDED|95.0|0.97|1.11|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L1 Group divided by INV\_MMR\_L3 Group) for antibodies to mumps virus at Day 42.||1.11|0.97|
70906184|NCT01702428|141301993|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to mumps.|Adjusted GMC ratio|1.07|||||TWO_SIDED|95.0|1.0|1.15|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L2 Group divided by INV\_MMR\_L1 Group) for antibodies to mumps virus at Day 42.||1.15|1.00|
70906185|NCT01702428|141301993|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to mumps.|Adjusted GMC ratio|1.11|||||TWO_SIDED|95.0|1.04|1.19|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L2 Group divided by INV\_MMR\_L3 Group) for antibodies to mumps virus at Day 42.||1.19|1.04|
70906186|NCT01702428|141301993|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to mumps.|Adjusted GMC ratio|0.96|||||TWO_SIDED|95.0|0.9|1.03|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L3 Group divided by INV\_MMR\_L1 Group) for antibodies to mumps virus at Day 42.||1.03|0.90|
70906187|NCT01702428|141301993|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to mumps.|Adjusted GMC ratio|0.9|||||TWO_SIDED|95.0|0.84|0.96|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L3 Group divided by INV\_MMR\_L2 Group) for antibodies to mumps virus at Day 42.||0.96|0.84|
70906188|NCT01702428|141301994|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to rubella virus.|Difference in seroresponse rate|0.14|||||TWO_SIDED|95.0|-1.3|1.58|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L1 Group minus INV\_MMR\_L2 Group) in percentage of subjects with anti-rubella antibody concentration ≥10 IU/mL.||1.58|-1.3|
70906189|NCT01702428|141301994|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to rubella virus.|Difference in seroresponse rate|-0.49|||||TWO_SIDED|95.0|-1.86|0.86|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L1 Group minus INV\_MMR\_L3 Group) in percentage of subjects with anti-rubella antibody concentration ≥10 IU/mL.||0.86|-1.86|
70906190|NCT01702428|141301994|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to rubella virus.|Difference in seroresponse rate|-0.62|||||TWO_SIDED|95.0|-2.02|0.74|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L2 Group minus INV\_MMR\_L3 Group) in percentage of subjects with anti-rubella antibody concentration ≥10 IU/mL.||0.74|-2.02|
70906191|NCT01702428|141301995|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.08|||||TWO_SIDED|95.0|1.01|1.15|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||"Adjusted GMC ratio (INV\_MMR\_L1 Group divided by INV\_MMR\_L2 Group) for antibodies to rubella virus at Day 42.~."||1.15|1.01|
70906192|NCT01702428|141301995|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.0|||||TWO_SIDED|95.0|0.94|1.07|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L1 Group divided by INV\_MMR\_L3 Group) for antibodies to rubella virus at Day 42.||1.07|0.94|
70906193|NCT01702428|141301995|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|0.93|||||TWO_SIDED|95.0|0.87|0.99|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L2 Group divided by INV\_MMR\_L1 Group) for antibodies to rubella virus at Day 42.||0.99|0.87|
70906194|NCT01702428|141301995|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|0.93|||||TWO_SIDED|95.0|0.87|0.99|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L2 Group divided by INV\_MMR\_L3 Group) for antibodies to rubella virus at Day 42.||0.99|0.87|
70906195|NCT01702428|141301995|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.0|||||TWO_SIDED|95.0|0.93|1.07|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L3 Group divided by INV\_MMR\_L1 Group) for antibodies to rubella virus at Day 42.||1.07|0.93|
70906196|NCT01702428|141301995|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.08|||||TWO_SIDED|95.0|1.01|1.15|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L3 Group divided by INV\_MMR\_L2 Group) for antibodies to rubella virus at Day 42.||1.15|1.01|
70906197|NCT01702428|141301996|NON_INFERIORITY|The Lower Limit (LL) of 2-sided 95 % CI for the difference in seroresponse (INV\_MMR Group minus COM\_MMR Group) should be ≥-5% for antibodies to measles virus.|Difference in seroresponse rate|0.18|||||TWO_SIDED|95.0|-0.68|1.25|||||Asymptotic standardized 95% CIs for the difference in seroresponse rate.|Difference in percentage (INV\_MMR Group minus COM\_MMR Group) of subjects with anti-measles antibody concentration at Day 42.||1.25|-0.68|
70906198|NCT01702428|141301997|NON_INFERIORITY|The LL of the 2-sided 95% CI on GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.67 for antibodies to measles virus.|Adjusted GMC ratio|0.98|||||TWO_SIDED|95.0|0.93|1.05|||ANOVA|95% CI for GMC ratio (INV\_MMR over COM\_ MMR) was computed using ANOVA (vaccine groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for antibodies to measles virus at Day 42.||1.05|0.93|
70906199|NCT01702428|141301998|NON_INFERIORITY|The LL of 2-sided 95 % CI for the difference in seroresponse (INV\_MMR Group minus COM\_MMR Group) should be ≥-5% for antibodies to mumps virus.|Difference in seroresponse rate|0.81|||||TWO_SIDED|95.0|-0.1|1.96|||||Asymptotic standardized 95% CIs for the difference in seroresponse rate.|Difference in percentage (INV\_MMR Group minus COM\_MMR Group) of subjects with anti-mumps antibody concentration at Day 42.||1.96|-0.1|
70906200|NCT01702428|141301999|NON_INFERIORITY|The LL of the 2-sided 95% CI on GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.67 for antibodies to mumps virus.|Adjusted GMC ratio|1.05|||||TWO_SIDED|95.0|0.99|1.11|||ANOVA|95% CI for GMC ratio (INV\_MMR over COM\_ MMR) was computed using ANOVA (vaccine groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for antibodies to mumps virus at Day 42.||1.11|0.99|
70906201|NCT01702428|141302000|NON_INFERIORITY|The LL of 2-sided 95 % CI for the difference in seroresponse (INV\_MMR Group minus COM\_MMR Group) should be ≥-5% for antibodies to rubella virus.|Difference in seroresponse rate|-1.15|||||TWO_SIDED|95.0|-2.0|-0.15|||||Asymptotic standardized 95% CIs for the difference in seroresponse rate.|Difference in percentage (INV\_MMR Group minus COM\_MMR Group) of subjects with anti-rubella antibody concentration at Day 42.||-0.15|-2.00|
70906202|NCT01702428|141302001|NON_INFERIORITY|The LL of the 2-sided 95% CI on GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.67 for antibodies to measles virus.|Adjusted GMC ratio|0.87|||||TWO_SIDED|95.0|0.83|0.92|||ANOVA|95% CI for GMC ratio (INV\_MMR over COM\_ MMR) was computed using ANOVA (vaccine groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for antibodies to rubella virus at Day 42.||0.92|0.83|
70906203|NCT01702428|141302002|NON_INFERIORITY|The LL of 2-sided 95 % CI for the difference in seroresponse (pooled INV\_MMR Group minus pooled COM\_MMR Group) should be ≥-10% for antibodies to VZV.|Difference in seroresponse rate|1.3|||||TWO_SIDED|95.0|-1.31|4.29|||||Asymptotic standardized 95% CIs for the difference in seroresponse rate.|In US sub-cohort: Difference in percentage (INV\_MMR Group minus COM\_MMR Group) of subjects with anti-VZV antibody concentration at Day 42.||4.29|-1.31|
70906204|NCT01702428|141302003|NON_INFERIORITY|The LL of the 2-sided 95% CI on GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.67 for antibodies to VZV.|Adjusted GMC ratio|1.01|||||TWO_SIDED|95.0|0.95|1.08|||ANOVA|95% CI for GMC ratio (INV\_MMR over COM\_ MMR) was computed using ANOVA (vaccine groups \& country as fixed effects) on log-transformed concentrations.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for antibodies to VZV virus at Day 42.||1.08|0.95|
70906205|NCT01702428|141302005|NON_INFERIORITY|The LL of the 2-sided 95% CI on GMC ratio (INV\_MMR Group over COM\_MMR Group) was ≥0.5 for antibodies to HAV virus.|Adjusted GMC ratio|0.98|||||TWO_SIDED|95.0|0.86|1.11|||ANOVA|95% CI for GMC ratio (INV\_MMR over COM\_ MMR) was computed using ANOVA (vaccine groups \& country as fixed effects) on log-transformed concentrations.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for antibodies to HAV virus at Day 42.||1.11|0.86|
70906206|NCT01702428|141302006|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.94|||||TWO_SIDED|95.0|0.85|1.05|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 1 antibody at Day 42.||1.05|0.85|
70906207|NCT01702428|141302006|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.99|||||TWO_SIDED|95.0|0.91|1.08|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 3 antibody at Day 42.||1.08|0.91|
70906208|NCT01702428|141302006|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.88||||||95.0|0.79|0.98|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 4 antibody at Day 42.||0.98|0.79|
70906209|NCT01702428|141302006|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.92|||||TWO_SIDED|95.0|0.83|1.01|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 5 antibody at Day 42.||1.01|0.83|
70906210|NCT01702428|141302006|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|1.01|||||TWO_SIDED|95.0|0.92|1.11|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 6A antibody at Day 42.||1.11|0.92|
70906211|NCT01702428|141302006|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.98|||||TWO_SIDED|95.0|0.89|1.09|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 6B antibody at Day 42.||1.09|0.89|
70906212|NCT01702428|141302006|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.94|||||TWO_SIDED|95.0|0.86|1.03|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 7F antibody at Day 42.||1.03|0.86|
70906213|NCT01702428|141302006|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.99|||||TWO_SIDED|95.0|0.9|1.08|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 9V antibody at Day 42.||1.08|0.90|
70906214|NCT01702428|141302006|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.91|||||TWO_SIDED|95.0|0.81|1.02|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 14 antibody at Day 42.||1.02|0.81|
70906215|NCT01702428|141302006|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.92|||||TWO_SIDED|95.0|0.84|1.02|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 18C antibody at Day 42.||1.02|0.84|
70906216|NCT01702428|141302006|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.97|||||TWO_SIDED|95.0|0.87|1.07|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 19A antibody at Day 42.||1.07|0.87|
70906217|NCT01702428|141302006|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.96|||||TWO_SIDED|95.0|0.87|1.06|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 19F antibody at Day 42.||1.06|0.87|
70906218|NCT01702428|141302006|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.95|||||TWO_SIDED|95.0|0.85|1.06|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 23F antibody at Day 42.||1.06|0.85|
70906219|NCT00574990|141302086|SUPERIORITY_OR_OTHER||chi square|12.99|STANDARD_ERROR_OF_MEAN|1.4||0.01|TWO_SIDED|||||Differences between roles and communication event content were assessed by Chi squared|Chi-squared|||Descriptive counts and chi squared were done on the observation data.||||0.01
70906220|NCT01355419|141302088|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||A power analysis conducted prior to the study predicted that a sample of 144 patients would provide an 80% power to detect a mean difference in sleep time of 40 minutes, assuming a standard deviation of 85 minutes and using a two-sided significance level of 5%.||||<0.05
70906221|NCT01355419|141302089|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Multiple regression modelling was used to determine whether actigraphic or polysomnographic data were predictors for physical activity, independently from age and BMI, stepwise forward selection of variables was performed.|Regression, Linear|||Multiple regression modelling was used to determine whether actigraphic or polysomnographic data were predictors for physical activity, independently from age and BMI, stepwise forward selection of variables was performed.||||<0.05
70906222|NCT00179010|141302091|SUPERIORITY_OR_OTHER|||||||0.854|||||||ANOVA|||||||0.854
70906223|NCT00453479|141302127|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.97|STANDARD_ERROR_OF_MEAN|5.596|||TWO_SIDED|95.0|-12.68|10.75|||||Comparison of SBP Day 1.|||10.75|-12.68|
70906224|NCT00453479|141302127|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1|STANDARD_ERROR_OF_MEAN|4.215|||TWO_SIDED|95.0|-12.92|4.72|||||Comparison of SBP Day 7.|||4.72|-12.92|
70906225|NCT00453479|141302127|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.21|STANDARD_ERROR_OF_MEAN|5.727|||TWO_SIDED|95.0|-5.78|18.19|||||Comparison of SBP Day 1.|||18.19|-5.78|
70906226|NCT00453479|141302127|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.76|STANDARD_ERROR_OF_MEAN|4.314|||TWO_SIDED|95.0|-13.79|4.27|||||Comparison of SBP Day 7.|||4.27|-13.79|
70906227|NCT00453479|141302127|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58|STANDARD_ERROR_OF_MEAN|2.138|||TWO_SIDED|95.0|-3.89|5.06|||||Comparison of DBP Day 1.|||5.06|-3.89|
70906228|NCT00453479|141302127|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.64|STANDARD_ERROR_OF_MEAN|2.382|||TWO_SIDED|95.0|-11.62|-1.65|||||Comparison of DBP Day 7.|||-1.65|-11.62|
70906229|NCT00453479|141302127|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.98|STANDARD_ERROR_OF_MEAN|2.248|||TWO_SIDED|95.0|-3.73|5.68|||||Comparison of DBP Day 1.|||5.68|-3.73|
70906230|NCT00453479|141302127|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.81|STANDARD_ERROR_OF_MEAN|2.504|||TWO_SIDED|95.0|-16.05|-5.57|||||Comparison of DBP Day 7.|||-5.57|-16.05|
70906231|NCT00453479|141302128|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.26|STANDARD_ERROR_OF_MEAN|3.745|||TWO_SIDED|95.0|-5.58|10.1|||||Comparison at Day 1.|||10.10|-5.58|
70906232|NCT00453479|141302128|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.62|STANDARD_ERROR_OF_MEAN|3.785|||TWO_SIDED|95.0|-5.3|10.54|||||Comparison at Day 7.|||10.54|-5.30|
70906233|NCT00453479|141302128|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|3.979|||TWO_SIDED|95.0|-8.17|8.48|||||Comparison at Day 1.|||8.48|-8.17|
70906234|NCT00453479|141302128|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.44|STANDARD_ERROR_OF_MEAN|4.021|||TWO_SIDED|95.0|-13.86|2.97|||||Comparison at Day 7.|||2.97|-13.86|
70906235|NCT00453479|141302129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.78|STANDARD_ERROR_OF_MEAN|4.611|||TWO_SIDED|95.0|-12.43|6.87|||||Comparison of SBP Day 1.|||6.87|-12.43|
70906236|NCT00453479|141302129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.88|STANDARD_ERROR_OF_MEAN|3.913|||TWO_SIDED|95.0|-10.07|6.31|||||Comparison of SBP Day 7.|||6.31|-10.07|
70906237|NCT00453479|141302129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.01|STANDARD_ERROR_OF_MEAN|4.718|||TWO_SIDED|95.0|-6.87|12.88|||||Comparison of SBP Day 1.|||12.88|-6.87|
70906238|NCT00453479|141302129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.5|STANDARD_ERROR_OF_MEAN|4.005|||TWO_SIDED|95.0|-11.88|4.89|||||Comparison of SBP Day 7.|||4.89|-11.88|
70906239|NCT00453479|141302129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|1.822|||TWO_SIDED|95.0|-4.09|3.54|||||Comparison of DBP Day 1.|||3.54|-4.09|
70906240|NCT00453479|141302129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.89|STANDARD_ERROR_OF_MEAN|2.116|||TWO_SIDED|95.0|-8.32|0.54|||||Comparison of DBP Day 7.|||0.54|-8.32|
70906241|NCT00453479|141302129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.75|STANDARD_ERROR_OF_MEAN|1.916|||TWO_SIDED|95.0|-5.76|2.26|||||Comparison of DBP Day 1.|||2.26|-5.76|
70906242|NCT00453479|141302129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.39|STANDARD_ERROR_OF_MEAN|2.224|||TWO_SIDED|95.0|-14.04|-4.73|||||Comparison of DBP Day 7.|||-4.73|-14.04|
70906243|NCT00453479|141302130|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-5.52|5.79|||||Comparison at Day 1.|||5.79|-5.52|
70906244|NCT00453479|141302130|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.39|STANDARD_ERROR_OF_MEAN|2.813|||TWO_SIDED|95.0|-3.5|8.28|||||Comparison at Day 7.|||8.28|-3.50|
70906245|NCT00453479|141302130|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.67|STANDARD_ERROR_OF_MEAN|2.869|||TWO_SIDED|95.0|-8.67|3.34|||||Comparison at Day 1.|||3.34|-8.67|
70906246|NCT00453479|141302130|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.84|STANDARD_ERROR_OF_MEAN|2.989|||TWO_SIDED|95.0|-10.1|2.41|||||Comparison at Day 7.|||2.41|-10.10|
70906247|NCT00453479|141302132|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.42|STANDARD_ERROR_OF_MEAN|8.157|||TWO_SIDED|95.0|-12.66|21.49|||||Comparison of QTcB Day 1.|||21.49|-12.66|
70906248|NCT00453479|141302132|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.02|STANDARD_ERROR_OF_MEAN|6.76|||TWO_SIDED|95.0|-5.13|23.17|||||Comparison of QTcB Day 7.|||23.17|-5.13|
70906249|NCT00453479|141302132|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.57|STANDARD_ERROR_OF_MEAN|8.51|||TWO_SIDED|95.0|-7.24|28.38|||||Comparison of QTcB Day 1.|||28.38|-7.24|
70906250|NCT00453479|141302132|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.5|STANDARD_ERROR_OF_MEAN|7.052|||TWO_SIDED|95.0|1.74|31.26|||||Comparison of QTcB Day 7.|||31.26|1.74|
70906251|NCT00453479|141302132|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.13|STANDARD_ERROR_OF_MEAN|8.908|||TWO_SIDED|95.0|-16.51|20.78|||||Comparison of QTcF Day 1.|||20.78|-16.51|
70906252|NCT00453479|141302132|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.29|STANDARD_ERROR_OF_MEAN|5.298|||TWO_SIDED|95.0|1.2|23.38|||||Comparison of QTcF Day 7.|||23.38|1.20|
70906253|NCT00453479|141302132|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.66|STANDARD_ERROR_OF_MEAN|9.171|||TWO_SIDED|95.0|-1.53|36.85|||||Comparison of QTcF Day 1.|||36.85|-1.53|
70906254|NCT00453479|141302132|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.32|STANDARD_ERROR_OF_MEAN|5.454|||TWO_SIDED|95.0|10.9|33.73|||||Comparison of QTcF Day 7.|||33.73|10.90|
70906255|NCT00453479|141302133|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.55|STANDARD_ERROR_OF_MEAN|5.262|||TWO_SIDED|95.0|-1.46|20.57|||||Comparison of QTcB Day 1.|||20.57|-1.46|
70906256|NCT00453479|141302133|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.39|STANDARD_ERROR_OF_MEAN|5.902|||TWO_SIDED|95.0|-3.97|20.74|||||Comparison of QTcB Day 7.|||20.74|-3.97|
70906257|NCT00453479|141302133|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.47|STANDARD_ERROR_OF_MEAN|5.49|||TWO_SIDED|95.0|-0.02|22.96|||||Comparison of QTcB Day 1.|||22.96|-0.02|
70906258|NCT00453479|141302133|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.28|STANDARD_ERROR_OF_MEAN|6.157|||TWO_SIDED|95.0|2.39|28.17|||||Comparison of QTcB Day 7.|||28.17|2.39|
70906259|NCT00453479|141302133|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.32|STANDARD_ERROR_OF_MEAN|4.622|||TWO_SIDED|95.0|-1.35|18.0|||||Comparison of QTcF Day 1.|||18.00|-1.35|
70906260|NCT00453479|141302133|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.75|STANDARD_ERROR_OF_MEAN|5.239|||TWO_SIDED|95.0|-2.21|19.72|||||Comparison of QTcF Day 7.|||19.72|-2.21|
70906261|NCT00453479|141302133|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.83|STANDARD_ERROR_OF_MEAN|4.759|||TWO_SIDED|95.0|6.87|26.79|||||Comparison of QTcF Day 1.|||26.79|6.87|
70906262|NCT00453479|141302133|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.46|STANDARD_ERROR_OF_MEAN|5.394|||TWO_SIDED|95.0|9.17|31.75|||||Comparison of QTcF Day 7.|||31.75|9.17|
70906263|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.147|STANDARD_ERROR_OF_MEAN|0.0921|||TWO_SIDED|95.0|-0.035|0.328|||||Comparison of FEV1, Day 1, 1 hour|||0.328|-0.035|
70906264|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.171|STANDARD_ERROR_OF_MEAN|0.0944|||TWO_SIDED|95.0|-0.015|0.357|||||Comparison of FEV1, Day 1, 2 hour|||0.357|-0.015|
70906265|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.085|||TWO_SIDED|95.0|-0.107|0.228|||||Comparison of FEV1, Day 1, 4 hour|||0.228|-0.107|
70906266|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.1195|||TWO_SIDED|95.0|-0.085|0.386|||||Comparison of FEV1, Day 1, 9 hour|||0.386|-0.085|
70906267|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.124|STANDARD_ERROR_OF_MEAN|0.1107|||TWO_SIDED|95.0|-0.094|0.343|||||Comparison of FEV1, Day 1, 12 hour|||0.343|-0.094|
70906268|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.163|STANDARD_ERROR_OF_MEAN|0.122|||TWO_SIDED|95.0|-0.077|0.404|||||Comparison of FEV1, Day 1, 24 hour|||0.404|-0.077|
70906269|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.236|STANDARD_ERROR_OF_MEAN|0.1057|||TWO_SIDED|95.0|0.027|0.444|||||Comparison of FEV1, Day 7, Baseline|||0.444|0.027|
70906270|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.229|STANDARD_ERROR_OF_MEAN|0.1292|||TWO_SIDED|95.0|-0.026|0.483|||||Comparison of FEV1, Day 7, 1 hour|||0.483|-0.026|
70906271|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.095|STANDARD_ERROR_OF_MEAN|0.1309|||TWO_SIDED|95.0|-0.163|0.353|||||Comparison of FEV1, Day 7, 2 hour|||0.353|-0.163|
70906272|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.173|STANDARD_ERROR_OF_MEAN|0.1243|||TWO_SIDED|95.0|-0.072|0.418|||||Comparison of FEV1, Day 7, 4 hour|||0.418|-0.072|
70906273|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.205|STANDARD_ERROR_OF_MEAN|0.1499|||TWO_SIDED|95.0|-0.09|0.501|||||Comparison of FEV1, Day 7, 9 hour|||0.501|-0.090|
70906274|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.143|||TWO_SIDED|95.0|-0.062|0.502|||||Comparison of FEV1, Day 7, 12 hour|||0.502|-0.062|
70906275|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.206|STANDARD_ERROR_OF_MEAN|0.152|||TWO_SIDED|95.0|-0.093|0.506|||||Comparison of FEV1, Day 7, 24 hour|||0.506|-0.093|
70906276|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.206|STANDARD_ERROR_OF_MEAN|0.097|||TWO_SIDED|95.0|0.015|0.397|||||Comparison of FEV1, Day 1, 1 hour|||0.397|0.015|
70906277|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.329|STANDARD_ERROR_OF_MEAN|0.0994|||TWO_SIDED|95.0|0.133|0.525|||||Comparison of FEV1, Day 1, 2 hour|||0.525|0.133|
70906278|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.266|STANDARD_ERROR_OF_MEAN|0.0895|||TWO_SIDED|95.0|0.09|0.443|||||Comparison of FEV1, Day 1, 4 hour|||0.443|0.090|
70906279|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.32|STANDARD_ERROR_OF_MEAN|0.1258|||TWO_SIDED|95.0|0.072|0.568|||||Comparison of FEV1, Day 1, 9 hour|||0.568|0.072|
70906280|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.172|STANDARD_ERROR_OF_MEAN|0.1165|||TWO_SIDED|95.0|-0.058|0.402|||||Comparison of FEV1, Day 1, 12 hour|||0.402|-0.058|
70906281|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.154|STANDARD_ERROR_OF_MEAN|0.1285|||TWO_SIDED|95.0|-0.099|0.407|||||Comparison of FEV1, Day 1, 24 hour|||0.407|-0.099|
70906282|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.256|STANDARD_ERROR_OF_MEAN|0.1113|||TWO_SIDED|95.0|0.036|0.475|||||Comparison of FEV1, Day 7, Baseline|||0.475|0.036|
70906283|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.296|STANDARD_ERROR_OF_MEAN|0.1361|||TWO_SIDED|95.0|0.027|0.564|||||Comparison of FEV1, Day 7, 1 hour|||0.564|0.027|
70906284|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.202|STANDARD_ERROR_OF_MEAN|0.1378|||TWO_SIDED|95.0|-0.069|0.474|||||Comparison of FEV1, Day 7, 2 hour|||0.474|-0.069|
70906285|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.207|STANDARD_ERROR_OF_MEAN|0.1309|||TWO_SIDED|95.0|-0.051|0.465|||||Comparison of FEV1, Day 7, 4 hour|||0.465|-0.051|
70906286|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.1579|||TWO_SIDED|95.0|-0.032|0.591|||||Comparison of FEV1, Day 7, 9 hour|||0.591|-0.032|
70906287|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.193|STANDARD_ERROR_OF_MEAN|0.1506|||TWO_SIDED|95.0|-0.104|0.49|||||Comparison of FEV1, Day 7, 12 hour|||0.490|-0.104|
70906288|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.1601|||TWO_SIDED|95.0|-0.136|0.495|||||Comparison of FEV1, Day 7, 24 hour|||0.495|-0.136|
70906289|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.137|STANDARD_ERROR_OF_MEAN|0.2029|||TWO_SIDED|95.0|-0.263|0.537|||||Comparison of FVC, Day 1, 1 hour|||0.537|-0.263|
70906290|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.131|STANDARD_ERROR_OF_MEAN|0.1965|||TWO_SIDED|95.0|-0.257|0.518|||||Comparison of FVC, Day 1, 2 hour|||0.518|-0.257|
70906291|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.038|STANDARD_ERROR_OF_MEAN|0.1908|||TWO_SIDED|95.0|-0.414|0.338|||||Comparison of FVC, Day 1, 4 hour|||0.338|-0.414|
70906292|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.2013|||TWO_SIDED|95.0|-0.337|0.457|||||Comparison of FVC, Day 1, 9 hour|||0.457|-0.337|
70906293|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.115|STANDARD_ERROR_OF_MEAN|0.2322|||TWO_SIDED|95.0|-0.343|0.572|||||Comparison of FVC, Day 1, 12 hour|||0.572|-0.343|
70906294|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.115|STANDARD_ERROR_OF_MEAN|0.1988|||TWO_SIDED|95.0|-0.277|0.507|||||Comparison of FVC, Day 1, 24 hour|||0.507|-0.277|
70906295|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.362|STANDARD_ERROR_OF_MEAN|0.2801|||TWO_SIDED|95.0|-0.19|0.914|||||Comparison of FVC, Day 7, Baseline|||0.914|-0.190|
70906296|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.269|STANDARD_ERROR_OF_MEAN|0.2696|||TWO_SIDED|95.0|-0.263|0.8|||||Comparison of FVC, Day 7, 1 hour|||0.800|-0.263|
70906297|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.021|STANDARD_ERROR_OF_MEAN|0.2648|||TWO_SIDED|95.0|-0.501|0.543|||||Comparison of FVC, Day 7, 2 hour|||0.543|-0.501|
70906298|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.177|STANDARD_ERROR_OF_MEAN|0.2606|||TWO_SIDED|95.0|-0.337|0.691|||||Comparison of FVC, Day 7, 4 hour|||0.691|-0.337|
70906299|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.266|STANDARD_ERROR_OF_MEAN|0.2684|||TWO_SIDED|95.0|-0.263|0.795|||||Comparison of FVC, Day 7, 9 hour|||0.795|-0.263|
70906300|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.367|STANDARD_ERROR_OF_MEAN|0.2923|||TWO_SIDED|95.0|-0.209|0.943|||||Comparison of FVC, Day 7, 12 hour|||0.943|-0.209|
70906301|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.242|STANDARD_ERROR_OF_MEAN|0.2665|||TWO_SIDED|95.0|-0.283|0.768|||||Comparison of FVC, Day 7, 24 hour|||0.768|-0.283|
70906302|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.152|STANDARD_ERROR_OF_MEAN|0.2106|||TWO_SIDED|95.0|-0.263|0.567|||||Comparison of FVC, Day 1, 1 hour|||0.567|-0.263|
70906303|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.321|STANDARD_ERROR_OF_MEAN|0.2039|||TWO_SIDED|95.0|-0.081|0.723|||||Comparison of FVC, Day 1, 2 hour|||0.723|-0.081|
70906304|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.311|STANDARD_ERROR_OF_MEAN|0.1981|||TWO_SIDED|95.0|-0.079|0.701|||||Comparison of FVC, Day 1, 4 hour|||0.701|-0.079|
70906305|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.348|STANDARD_ERROR_OF_MEAN|0.209|||TWO_SIDED|95.0|-0.064|0.76|||||Comparison of FVC, Day 1, 9 hour|||0.760|-0.064|
70906306|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.245|STANDARD_ERROR_OF_MEAN|0.241|||TWO_SIDED|95.0|-0.23|0.72|||||Comparison of FVC, Day 1, 12 hour|||0.720|-0.230|
70906307|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.162|STANDARD_ERROR_OF_MEAN|0.2063|||TWO_SIDED|95.0|-0.245|0.569|||||Comparison of FVC, Day 1, 24 hour|||0.569|-0.245|
70906308|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.535|STANDARD_ERROR_OF_MEAN|0.2907|||TWO_SIDED|95.0|-0.038|1.108|||||Comparison of FVC, Day 7, Baseline|||1.108|-0.038|
70906309|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.623|STANDARD_ERROR_OF_MEAN|0.2798|||TWO_SIDED|95.0|0.072|1.175|||||Comparison of FVC, Day 7, 1 hour|||1.175|0.072|
70906310|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.459|STANDARD_ERROR_OF_MEAN|0.2748|||TWO_SIDED|95.0|-0.083|1.0|||||Comparison of FVC, Day 7, 2 hour|||1.000|-0.083|
70906311|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.464|STANDARD_ERROR_OF_MEAN|0.2705|||TWO_SIDED|95.0|-0.069|0.997|||||Comparison of FVC, Day 7, 4 hour|||0.997|-0.069|
70906312|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.445|STANDARD_ERROR_OF_MEAN|0.2786|||TWO_SIDED|95.0|-0.104|0.994|||||Comparison of FVC, Day 7, 9 hour|||0.994|-0.104|
70906313|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.284|STANDARD_ERROR_OF_MEAN|0.3034|||TWO_SIDED|95.0|-0.314|0.882|||||Comparison of FVC, Day 7, 12 hour|||0.882|-0.314|
70906314|NCT00453479|141302134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.384|STANDARD_ERROR_OF_MEAN|0.2766|||TWO_SIDED|95.0|-0.162|0.929|||||Comparison of FVC, Day 7, 24 hour|||0.929|-0.162|
70906315|NCT00453479|141302139|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.233|STANDARD_ERROR_OF_MEAN|3.3333|||TWO_SIDED|95.0|-4.743|9.21|||||Comparison of maximum heart rate Day 1.|||9.210|-4.743|
70906316|NCT00453479|141302139|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.73|STANDARD_ERROR_OF_MEAN|8.0907|||TWO_SIDED|95.0|-11.2|22.664|||||Comparison of maximum heart rate Day 7.|||22.664|-11.200|
70906317|NCT00453479|141302139|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.272|STANDARD_ERROR_OF_MEAN|3.239|||TWO_SIDED|95.0|-8.051|5.507|||||Comparison of maximum heart rate Day 1.|||5.507|-8.051|
70906318|NCT00453479|141302139|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.988|STANDARD_ERROR_OF_MEAN|7.8616|||TWO_SIDED|95.0|-15.47|17.443|||||Comparison of maximum heart rate Day 7.|||17.443|-15.470|
70906319|NCT00453479|141302139|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.734|STANDARD_ERROR_OF_MEAN|3.441|||TWO_SIDED|95.0|-4.468|9.936|||||Comparison of mean heart rate Day 1.|||9.936|-4.468|
70906320|NCT00453479|141302139|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.783|STANDARD_ERROR_OF_MEAN|2.9409|||TWO_SIDED|95.0|-1.372|10.938|||||Comparison of mean heart rate Day 7.|||10.938|-1.372|
70906321|NCT00453479|141302139|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.074|STANDARD_ERROR_OF_MEAN|3.3103|||TWO_SIDED|95.0|-8.003|5.854|||||Comparison of mean heart rate Day 1.|||5.854|-8.003|
70906322|NCT00453479|141302139|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.569|STANDARD_ERROR_OF_MEAN|2.8291|||TWO_SIDED|95.0|-4.353|7.49|||||Comparison of mean heart rate Day 7.|||7.490|-4.353|
70906323|NCT00453479|141302143|SUPERIORITY_OR_OTHER||Ratio|1.139|STANDARD_ERROR_OF_MEAN|0.1939|||TWO_SIDED|90.0|0.811|1.601|||||SE logs is presented as standard error of mean. Comparison of GSK233705 50 µg twice daily Day 7 versus Day 1.|||1.601|0.811|
70906324|NCT00453479|141302143|SUPERIORITY_OR_OTHER||Ratio|1.06|STANDARD_ERROR_OF_MEAN|0.2057|||TWO_SIDED|90.0|0.739|1.52|||||SE logs is presented as standard error of mean. Comparison of GSK233705 100 µg twice daily Day 7 versus Day 1.|||1.520|0.739|
70906325|NCT00453479|141302144|SUPERIORITY_OR_OTHER||Ratio|1.408|STANDARD_ERROR_OF_MEAN|0.234|||TWO_SIDED|90.0|0.934|2.122|||||SE logs is presented as standard error of mean. Comparison of Cmax AM dose for GSK233705 50 µg twice daily Day 7 versus Day 1.|||2.122|0.934|
70906326|NCT00453479|141302144|SUPERIORITY_OR_OTHER||Ratio|1.19|STANDARD_ERROR_OF_MEAN|0.2482|||TWO_SIDED|90.0|0.77|1.838|||||SE logs is presented as standard error of mean. Comparison of Cmax AM dose for GSK233705 100 µg twice daily Day 7 versus Day 1.|||1.838|0.770|
70906327|NCT00453479|141302144|SUPERIORITY_OR_OTHER||Ratio|0.979|STANDARD_ERROR_OF_MEAN|0.2269|||TWO_SIDED|90.0|0.658|1.457|||||SE logs is presented as standard error of mean. Comparison of Cmax PM dose for GSK233705 50 µg twice daily Day 7 versus Day 1.|||1.457|0.658|
70906328|NCT00453479|141302144|SUPERIORITY_OR_OTHER||Ratio|1.028|STANDARD_ERROR_OF_MEAN|0.2407|||TWO_SIDED|90.0|0.674|1.568|||||SE logs is presented as standard error of mean. Comparison of Cmax PM dose for GSK233705 100 µg twice daily Day 7 versus Day 1.|||1.568|0.674|
70906329|NCT00453479|141302146|SUPERIORITY_OR_OTHER||Ratio|2.556|STANDARD_ERROR_OF_MEAN|0.131|||TWO_SIDED|90.0|2.033|3.213|||||SE logs is presented as standard error of mean. Comparison of Ae AM dose for GSK233705 50 µg twice daily Day 7 versus Day 1.|||3.213|2.033|
70906330|NCT00453479|141302146|SUPERIORITY_OR_OTHER||Ratio|1.644|STANDARD_ERROR_OF_MEAN|0.138|||TWO_SIDED|90.0|1.29|2.095|||||SE logs is presented as standard error of mean. Comparison of Ae AM dose for GSK233705 100 µg twice daily Day 7 versus Day 1.|||2.095|1.290|
70906331|NCT01763788|141302150|SUPERIORITY||Stratified Hazard Ratio|0.656||||0.0161|TWO_SIDED|95.0|0.465|0.926|||Stratified Log Rank|||||0.926|0.465|0.0161
70906332|NCT02354859|141302167|SUPERIORITY||Difference in Proportions|5.9||||0.811|TWO_SIDED|95.0|-11.2|22.4|||Cochran-Mantel-Haenszel||The estimate is adjusted for baseline FEV1 % predicted strata (\<50% of predicted, between 50% and 70% of predicted, and \>70% of predicted).|||22.4|-11.2|0.811
70906333|NCT02354859|141302168|SUPERIORITY||Difference in Proportions-SAE inicidence|3.1||||0.807|TWO_SIDED|95.0|-10.6|16.6|||Fisher Exact||95% confidence interval calculated using the Newcombe-Wilson method without continuity correction.|||16.6|-10.6|0.807
70906334|NCT02354859|141302169|SUPERIORITY||Rate Ratio|0.81||||0.002|TWO_SIDED|95.0|0.71|0.93|||Poisson Regression|||Rate Ratio for Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks of all participants (not per participant) in the trial was as follows: in the IV Gallium group was 486.86 and in the Placebo group was 473.57.||0.93|0.71|0.002
70906335|NCT02354859|141302169|SUPERIORITY||Rate Ratio|0.89||||0.783|TWO_SIDED|95.0|0.39|2.03|||Poisson Regression|||Rate Ratio for Serious Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks in the IV Gallium group was 486.86 and in the Placebo group was 473.57.||2.03|0.39|0.783
70906336|NCT02354859|141302170|SUPERIORITY||Mean Difference (Final Values)|2.05||||0.479|TWO_SIDED|95.0|-3.66|7.77|||Mixed Models Analysis||Analysis includes all data for relative change from baseline at Day 6, Day 14, Day 28, and Day 56. Mixed-effects repeated measures model includes terms for the baseline FEV1 (liters), treatment, visit and a visit-by-visit interaction.|||7.77|-3.66|0.479
70906337|NCT02354859|141302171|SUPERIORITY||Mean Difference (Final Values)|-0.74||||0.054|TWO_SIDED|95.0|-1.49|0.01|||Mixed Models Analysis||Analysis includes all data for relative change from baseline at Day 28 and Day 56. Mixed-effects repeated measures model includes terms for the baseline Pa density (log10 (CFU)), treatment, visit and a visit-by-visit interaction.|||0.01|-1.49|0.054
70906338|NCT02354859|141302172|SUPERIORITY||Mean Difference (Final Values)|4.23||||0.053|TWO_SIDED|95.0|-0.06|8.53|||Mixed Models Analysis||Analysis includes all data for relative change from baseline at Day 6, Day 14, Day 28, and Day 56. Mixed-effects repeated measures model includes terms for the baseline CFRSD-CRISS score, treatment, visit and a visit-by-visit interaction.|||8.53|-0.06|0.053
70906339|NCT00708305|141302178|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0||||0.9762||95.0|-0.21|0.2||No adjustment was made for multiple comparisons as the primary comparison was predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis is no difference between treatments in comparison. Tests were 2-sided at 5% significance levels.||0.20|-0.21|0.9762
70906340|NCT00708305|141302179|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|0.49|||<|0.0001|TWO_SIDED|95.0|0.28|0.7||No adjustment was made for multiple comparisons as the comparisons were predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis is no difference between treatments being compared. Tests were 2 sided at 5% significance levels.||0.70|0.28|<0.0001
70906341|NCT00708305|141302179|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.44|||<|0.0001||95.0|1.23|1.65||No adjustment was made for multiple comparisons because the comparisons were predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.||1.65|1.23|<0.0001
70906342|NCT00708305|141302179|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.49|||<|0.0001||95.0|0.28|0.7||No adjustment was made for multiple comparisons because the comparisons were predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.||0.70|0.28|<0.0001
70906343|NCT00708305|141302179|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.44|||<|0.0001|TWO_SIDED|95.0|1.23|1.65||No adjustment was made for multiple comparisons because the comparison was predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.||1.65|1.23|<0.0001
70906344|NCT00708305|141302179|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.95|||<|0.0001|TWO_SIDED|95.0|0.74|1.16||No adjustment was made for multiple comparisons as the comparisons were predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.||1.16|0.74|<0.0001
70906345|NCT00708305|141302180|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.83||||0.0151|TWO_SIDED|95.0|0.12|1.72||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||1.72|0.12|0.0151
70906346|NCT00708305|141302180|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.36|||<|0.0001|TWO_SIDED|95.0|0.69|2.36||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||2.36|0.69|<0.0001
70906347|NCT00708305|141302180|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.01|||<|0.0001|TWO_SIDED|95.0|2.06|4.05||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis is no difference between treatments. Tests were 2-sided.||4.05|2.06|<0.0001
70906348|NCT00708305|141302180|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.75|||<|0.0001|TWO_SIDED|95.0|0.41|1.27||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||1.27|0.41|<0.0001
70906349|NCT00708305|141302180|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.1|||<|0.0001|TWO_SIDED|95.0|1.5|2.74||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||2.74|1.50|<0.0001
70906350|NCT00708305|141302180|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.01|||<|0.0001|TWO_SIDED|95.0|0.73|1.35||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||1.35|0.73|<0.0001
70906351|NCT00708305|141302181|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.08||||0.5545|TWO_SIDED|95.0|-0.22|0.47||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.47|-0.22|0.5545
70906352|NCT00708305|141302181|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.4||||0.0003|TWO_SIDED|95.0|0.15|0.71||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.71|0.15|0.0003
70967410|NCT01431274|141440929|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.048|STANDARD_ERROR_OF_MEAN|0.026||0.0632|TWO_SIDED|95.0|-0.003|0.098||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.098|-0.003|0.0632
70906353|NCT00708305|141302181|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.91|||<|0.0001|TWO_SIDED|95.0|0.58|1.56||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||1.56|0.58|<0.0001
70906354|NCT00708305|141302181|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.36|||<|0.0001|TWO_SIDED|95.0|0.15|0.68||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signal Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.68|0.15|<0.0001
70906355|NCT00708305|141302181|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.91|||<|0.0001|TWO_SIDED|95.0|0.58|1.35||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||1.35|0.58|<0.0001
70906356|NCT00708305|141302181|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.37|||<|0.0001|TWO_SIDED|95.0|0.26|0.56||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.56|0.26|<0.0001
70906357|NCT00708305|141302182|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.02||||0.6865|TWO_SIDED|95.0|-0.13|0.08||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.08|-0.13|0.6865
70906358|NCT00708305|141302182|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.04||||0.1756|TWO_SIDED|95.0|-0.02|0.12||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.12|-0.02|0.1756
70906359|NCT00708305|141302182|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.24|||<|0.0001|TWO_SIDED|95.0|0.16|0.38||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.38|0.16|<0.0001
70906360|NCT00708305|141302182|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.11||||0.0023|TWO_SIDED|95.0|0.04|0.22||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.22|0.04|0.0023
70906361|NCT00708305|141302182|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.34|||<|0.0001|TWO_SIDED|95.0|0.22|0.51||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.51|0.22|<0.0001
70906362|NCT00708305|141302182|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.18|||<|0.0001|TWO_SIDED|95.0|0.12|0.25||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.25|0.12|<0.0001
70906363|NCT00708305|141302183|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.04||||0.0783|TWO_SIDED|95.0|-0.08|0.0||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.00|-0.08|0.0783
70906364|NCT00708305|141302183|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.03||||0.0531|TWO_SIDED|95.0|0.0|0.07||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.07|0.00|0.0531
70906365|NCT00708305|141302183|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.1|||<|0.0001|TWO_SIDED|95.0|0.07|0.14||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.14|0.07|<0.0001
70906366|NCT00708305|141302183|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.08||||0.0005|TWO_SIDED|95.0|0.03|0.15||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.15|0.03|0.0005
70906367|NCT00708305|141302183|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.12|||<|0.0001|TWO_SIDED|95.0|0.08|0.2||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.20|0.08|<0.0001
70906368|NCT00708305|141302183|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.07|||<|0.0001|TWO_SIDED|95.0|0.04|0.1||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.10|0.04|<0.0001
70906369|NCT00708305|141302184|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.01||||0.4309|TWO_SIDED|95.0|-0.03|0.01||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.01|-0.03|0.4309
70906370|NCT00708305|141302184|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.02||||0.0726|TWO_SIDED|95.0|0.0|0.04||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.04|0.00|0.0726
70906371|NCT00708305|141302184|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.04|||<|0.0001|TWO_SIDED|95.0|0.03|0.06||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.06|0.03|<0.0001
70906372|NCT00708305|141302184|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.03||||0.0107|TWO_SIDED|95.0|0.01|0.06||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.06|0.01|0.0107
70906373|NCT00708305|141302184|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.05|||<|0.0001|TWO_SIDED|95.0|0.03|0.07|||Wilcoxon Signed Rank Test|No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.07|0.03|<0.0001
70906374|NCT00708305|141302184|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.03||||0.0012|TWO_SIDED|95.0|0.01|0.04||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.04|0.01|0.0012
70906375|NCT04711460|141302185|SUPERIORITY|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Mean Difference (Final Values)|0.003|STANDARD_DEVIATION|5.59||0.003|TWO_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|t-test, 2 sided|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||||||0.003
70906376|NCT04711460|141302185|SUPERIORITY|The threshold for statistical significance was set at p=0.05. No power analysis was conducted.|Mean Difference (Final Values)|0.009|STANDARD_DEVIATION|5.59||0.009|ONE_SIDED|95.0||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|ANOVA|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|||||0.009
70906377|NCT04711460|141302185|SUPERIORITY|The Tukey Kramer Post Hoc Test q value = 0.05 threshold|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.609|<|0.05|TWO_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Tukey Kramer Post-Hoc|Threshold of statistically significance was set at p=0.05.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|||||<0.05
70906378|NCT04711460|141302185|SUPERIORITY|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|5.13||0.003|TWO_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|t-test, 2 sided|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||||0.003
70906379|NCT04711460|141302185|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|5.07||0.454|ONE_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|ANOVA|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||||0.454
70906380|NCT04711460|141302186|SUPERIORITY|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|7.194||0.002|TWO_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|t-test, 2 sided|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|||||0.002
70906381|NCT04711460|141302186|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|6.09||0.054|ONE_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|ANOVA|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||||0.054
70906382|NCT04711460|141302186|SUPERIORITY|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|6.93||0.019|TWO_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|t-test, 2 sided|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||||0.019
70906383|NCT04711460|141302186|SUPERIORITY|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|6.04||0.101|ONE_SIDED|95.0||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|ANOVA|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||||0.101
70906384|NCT00390455|141302200|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The null hypothesis then is that the hazard ratio of the two treatment arms is 1.0; the alternative hypothesis is that the hazard ratio of the control to the experimental regimen is 1.5 (0.67). The test of these hypotheses is one-sided (alpha = 0.025), and interim analyses will be used to stop for futility and superiority. Under these assumptions, there is at least 90% power to detect the stated difference in median PFS between the two treatment arms.|Hazard Ratio (HR)|1.04||||0.37|TWO_SIDED|95.0|0.82|1.33||Tests were stratified by prior tamoxifen therapy (yes/no) and bone disease only (yes/no).|Log Rank|||||1.33|0.82|0.37
70906385|NCT04397523|141302208|OTHER|||||||0.05||||||p=0.00000|ANOVA|df 2||||||0.05
70906386|NCT04397523|141302213|OTHER|||||||0.05||||||Chi- square = 24.98174, p = 0.00000|Chi-squared|df = 2||Overall survival between the three WHO score groups 3, 4 and 5||||0.05
70906387|NCT04397523|141302213|OTHER|||||||0.05||||||p=0.000|Chi-squared|df = 2||Correlation of mortality versus WHO disease progression score of patients||||0.05
70906388|NCT04397523|141302213|OTHER|||||||0.05||||||p = 0.000|Chi-squared|df = 1||Correlation of mortality versus stay in the intensive care unit (ICU)||||0.05
70906389|NCT01275196|141302214|NON_INFERIORITY_OR_EQUIVALENCE|This trial was powered to detect an odds ratio of at least 2.333 which corresponds, for example, to increases of 18% (from 22% to 40%) and increases of 20% (from 30% to 50%).||||||0.0001|||||||Cochran-Mantel-Haenszel|||||||0.0001
70906390|NCT00981825|141302236|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70906391|NCT02341144|141302255|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
70906392|NCT02341144|141302256|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
70906393|NCT02341144|141302257|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
70906394|NCT02341144|141302258|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
70906395|NCT02341144|141302259|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||||||0.44
70906396|NCT05033080|141302260|NON_INFERIORITY|The non-inferiority margin represents a clinically acceptable loss of effectiveness that margin preserve at least 50% of the treatment effect of the active control (ELX/TEZ/IVA) compared to placebo, where the treatment effect is estimated by the lower bound of the 95% confidence interval (CI).|LS Mean difference|0.2|||<|0.0001|TWO_SIDED|95.0|-0.7|1.1|||Mixed Models Repeated Measures|||||1.1|-0.7|< 0.0001
70906397|NCT05033080|141302261|SUPERIORITY||LS Mean difference|-8.4|||<|0.0001|TWO_SIDED|95.0|-10.5|-6.3|||Mixed Models Repeated Measures|||||-6.3|-10.5|< 0.0001
70906398|NCT05033080|141302262|OTHER||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.55|3.15|||Generalized Estimated Equation Model|||||3.15|1.55|< 0.0001
70906399|NCT05033080|141302263|OTHER||Odds Ratio (OR)|2.87|||<|0.0001|TWO_SIDED|95.0|2.0|4.12|||Generalized Estimated Equation Model|||||4.12|2.00|< 0.0001
70906400|NCT03560245|141302265|EQUIVALENCE|"The change from baseline to Week 13 in the SIB total score was summarized descriptively and compared using Analysis of Covariance (ANCOVA) adjusted for baseline SIB total score.~If the normality assumption was not met, a non-parametric method or a rank-ANCOVA analysis (i.e., an ANCOVA analysis on rank-transformed data) was to be used."||||||0.373|||||||t-test, 2 sided|||||||0.3730
70906401|NCT01850082|141302292|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.47|TWO_SIDED|95.0|0.83|1.51|||Regression, Cox|||||1.51|0.83|0.47
70906402|NCT01850082|141302293|SUPERIORITY|||||||0.821|||||||Chi-squared|||||||0.821
70906403|NCT01850082|141302294|SUPERIORITY||||||>|0.99|||||||Chi-squared|||||||>0.99
70906404|NCT01850082|141302295|SUPERIORITY||Hazard Ratio (HR)|0.923||||0.517|TWO_SIDED|95.0|0.724|1.176|||Regression, Cox|||||1.176|0.724|0.517
70906405|NCT05822921|141302344|OTHER|Independent t-test was used.||||||0.871|||||||t-test, 2 sided|||||||.871
70906406|NCT05822921|141302345|OTHER|Independent t-test was used.||||||0.896|||||||t-test, 2 sided|||||||0.896
70906407|NCT05822921|141302346|OTHER|Independent t-test was used.||||||0.351|||||||t-test, 2 sided|||||||0.351
70906408|NCT01857622|141302428|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|3.8|||||TWO_SIDED|95.0|-14.7|26.8|||Wilcoxon (Mann-Whitney)|no statistical test||||26.8|-14.7|
70906409|NCT01857622|141302428|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|2.7|||||TWO_SIDED|95.0|-15.4|25.2|||Wilcoxon (Mann-Whitney)|||||25.2|-15.4|
70906410|NCT01950273|141302462|NON_INFERIORITY_OR_EQUIVALENCE|Standard equivalence limit 80% to 125%.|Least Squares (LS) mean ratio|89.53|||||TWO_SIDED|90.0|75.42|106.29|||||Ratio of the adjusted geometric means calculated as (LS mean ratio of BI 695500/Rituximab (MabThera®)).|||106.29|75.42|
70906411|NCT01950273|141302463|NON_INFERIORITY_OR_EQUIVALENCE|Standard equivalence limit 80% to 125%.|Least Squares (LS) means ratio|94.6||||||90.0|85.04|105.23|||||Ratio of the adjusted geometric means calculated as (LS mean ratio of BI 695500/Rituximab (MabThera®)).|||105.23|85.04|
70906412|NCT01950273|141302464|NON_INFERIORITY_OR_EQUIVALENCE|Standard equivalence limit 80% to 125%.|Least Squares (LS) means ratio|89.94|||||TWO_SIDED|90.0|77.62|104.23|||||Ratio of the adjusted geometric means calculated as (LS mean ratio of BI 695500/Rituximab (MabThera®)).|||104.23|77.62|
70906413|NCT01950273|141302465|NON_INFERIORITY_OR_EQUIVALENCE|Standard equivalence limit 80% to 125%.|Least Squares (LS) means ratio|97.65|||||TWO_SIDED|90.0|90.45|105.42|||||Ratio of the adjusted geometric means calculated as (LS mean ratio of BI 695500/Rituximab (MabThera®)).|||105.42|90.45|
70906414|NCT01950273|141302466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|249.2|||||TWO_SIDED|90.0|-210.6|709.0|||||Mean difference calculated as BI 695500-Rituximab (MabThera®).|||709|-210.6|
70906415|NCT01950273|141302468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.4|||||TWO_SIDED|95.0|-29.4|11.1|||||Difference in ORR calculated as ORR (BI695500) - ORR (MabThera®). The confidence interval represented is 95% difference in proportions.|||11.1|-29.4|
70906416|NCT01950273|141302469|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.0|||||TWO_SIDED|95.0|-18.0|22.1|||||Difference in TEAE incidence calculated as BI695500 - TEAE incidence (MabThera®). The confidence interval represented is 95% difference in proportions.|||22.1|-18.0|
70906417|NCT01254565|141302472|SUPERIORITY|The primary endpoint was tested at the 0.05 level (1-sided).|LS Mean Difference|-76.9|||<|0.0001|TWO_SIDED|95.0|-86.9|-50.0|||ANOVA|A rank analysis of variance (ANOVA) model with treatment and screening PTH (\< 600 pg/mL or ≥ 600 pg/mL) as factors.||The hypothesis for this study (Cohorts 2 and 3) was that intravenous administration of etelcalcetide is superior to placebo for the reduction of PTH after TIW dosing in hemodialysis patients with secondary HPT. This hypothesis was tested in Cohorts 2 and 3 by comparing the mean percent changes from baseline in pre-hemodialysis PTH levels collected during the efficacy phase between the etelcalcetide and placebo groups within each cohort.||-50.0|-86.9|<0.0001
70906418|NCT01254565|141302472|SUPERIORITY|The primary endpoint was tested at the 0.05 level (1-sided).|LS Mean Difference|-36.7||||0.0032|TWO_SIDED|95.0|-59.8|-13.6|||ANOVA|ANOVA model with treatment and screening PTH (\< 600 pg/mL or ≥ 600 pg/mL) as factors.||The hypothesis for this study (Cohorts 2 and 3) was that intravenous administration of etelcalcetide is superior to placebo for the reduction of PTH after TIW dosing in hemodialysis patients with secondary HPT. This hypothesis was tested in Cohorts 2 and 3 by comparing the mean percent changes from baseline in pre-hemodialysis PTH levels collected during the efficacy phase between the etelcalcetide and placebo groups within each cohort.||-13.6|-59.8|0.0032
70906419|NCT01254565|141302473|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
70906420|NCT01254565|141302473|SUPERIORITY|||||||0.0968|||||||Fisher Exact|||||||0.0968
70906421|NCT01254565|141302474|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
70906422|NCT01254565|141302474|SUPERIORITY|||||||0.073|||||||Fisher Exact|||||||0.0730
70906423|NCT01254565|141302475|SUPERIORITY||LS Mean Difference|-11.3|||<|0.0001|TWO_SIDED|95.0|-16.4|-8.4|||ANOVA|A rank ANOVA model with treatment and screening PTH (\< 600 or ≥ 600 pg/mL) as factors.||||-8.4|-16.4|< 0.0001
70906424|NCT01254565|141302475|SUPERIORITY||LS Mean Difference|-6.9||||0.0235|TWO_SIDED|95.0|-12.8|-1.0|||ANOVA|ANOVA model with treatment and screening PTH (\< 600 or ≥ 600 pg/mL) as factors.||||-1.0|-12.8|0.0235
70906425|NCT01254565|141302476|SUPERIORITY||LS Mean Difference|-4.2||||0.2255|TWO_SIDED|95.0|-18.6|5.7|||ANOVA|A rank ANOVA model with treatment and screening PTH (\< 600 or ≥ 600 pg/mL) as factors.||||5.7|-18.6|0.2255
70906426|NCT01254565|141302476|SUPERIORITY||LS mean Difference|-21.8||||0.1751|TWO_SIDED|95.0|-29.8|5.9|||ANOVA|A rank ANOVA model with treatment and screening PTH (\< 600 or ≥ 600 pg/mL) as factors.||||5.9|-29.8|0.1751
70906427|NCT01254565|141302477|SUPERIORITY||LS Mean Difference|-11.2||||0.0112|TWO_SIDED|95.0|-26.8|-4.9|||ANOVA|A rank ANOVA model with treatment and screening PTH (\< 600 or ≥ 600 pg/mL) as factors.||||-4.9|-26.8|0.0112
70906428|NCT01254565|141302477|SUPERIORITY||LS Mean Difference|-27.7||||0.0554|TWO_SIDED|95.0|-39.3|-1.6|||ANOVA|A rank ANOVA model with treatment and screening PTH (\< 600 or ≥ 600 pg/mL) as factors.||||-1.6|-39.3|0.0554
70906429|NCT04076020|141302485|SUPERIORITY|||||||0.99||||||Results presented from Wilcoxon-Mann-Whitney test with PDC as the dependent variable.|Wilcoxon (Mann-Whitney)|||Proportion of days covered (PDC) at 12 months. A sample size of 119 in each study arm enabled us to detect a minimum difference in PDC of 11.7% with 85% power (assuming a standard deviation=30%). Our power calculations assume use of 2-sided tests with 0.05 significance level.||||0.99
70906430|NCT04076020|141302485|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|||Proportion of days covered (PDC) analyzed as a binary variable with optimal adherence determined as ≥0.80) variables using logistic regression and adjustment for trial stratification factors. Our power calculations assume use of 2-sided tests with 0.05 significance level.||||<0.05
70906431|NCT04076020|141302486|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|||Difference in self-reported adherence reported across baseline, 4-, 8-, and 12-month visits using generalized estimating equations and adjusted for trial stratification factors.||||<0.05
70906432|NCT02761629|141302497|SUPERIORITY_OR_OTHER||Difference in Response Rates|12.7||||0.0536|TWO_SIDED|95.0|-0.01|26.6|||Fisher Exact||Exact 95% confidence interval was from the binomial distribution for response rate.|||26.6|-0.01|0.0536
70906433|NCT02761629|141302500|SUPERIORITY_OR_OTHER|||||||0.0175|||||||Fisher Exact|||||||0.0175
70906434|NCT02001974|141302516|OTHER|||||||0.0341|||||||ANOVA|||DF1681Y Cmax at Day -3||||0.0341
70906435|NCT02001974|141302516|OTHER|||||||0.0636|||||||ANOVA|||DF1681Y Cmax at Day -3||||0.0636
70906436|NCT02001974|141302516|OTHER|||||||0.0487|||||||ANOVA|||DF1681Y Cmax at Day 1||||0.0487
70906437|NCT02001974|141302516|OTHER|||||||0.3498|||||||ANOVA|||DF1681Y Cmax at Day 1||||0.3498
70906438|NCT02001974|141302516|OTHER|||||||0.0096|||||||ANOVA|||DF1681Y Cmax at Day 8||||0.0096
70906439|NCT02001974|141302516|OTHER|||||||0.1374|||||||ANOVA|||DF1681Y Cmax at Day 8||||0.1374
70906440|NCT02001974|141302516|OTHER|||||||0.0065|||||||ANOVA|||DF1681Y Cmax at Day 21||||0.0065
70906441|NCT02001974|141302516|OTHER|||||||0.147|||||||ANOVA|||DF1681Y Cmax at Day 21||||0.1470
70906442|NCT02001974|141302517|OTHER|||||||0.0015|||||||ANOVA|||DF2243 Cmax at Day -3||||0.0015
70906443|NCT02001974|141302517|OTHER|||||||0.0176|||||||ANOVA|||DF2243 Cmax at Day -3||||0.0176
70906444|NCT02001974|141302517|OTHER|||||||0.0048|||||||ANOVA|||DF2243 Cmax at Day 1||||0.0048
70906445|NCT02001974|141302517|OTHER|||||||0.2083|||||||ANOVA|||DF2243 Cmax at Day 1||||0.2083
70906446|NCT02001974|141302517|OTHER|||||||0.0111|||||||ANOVA|||DF2243 Cmax at Day 8||||0.0111
70906447|NCT02001974|141302517|OTHER|||||||0.1441|||||||ANOVA|||DF2243 Cmax at Day 8||||0.1441
70906448|NCT02001974|141302517|OTHER|||||||0.0283|||||||ANOVA|||DF2243 Cmax at Day 21||||0.0283
70906449|NCT02001974|141302517|OTHER|||||||0.1331|||||||ANOVA|||DF2243 Cmax at Day 21||||0.1331
70906450|NCT02001974|141302518|OTHER|||||||0.0097|||||||ANOVA|||DF2188Y, Cmax, Day -3||||0.0097
70906451|NCT02001974|141302518|OTHER|||||||0.0354|||||||ANOVA|||DF2188Y, Cmax, Day -3||||0.0354
70906452|NCT02001974|141302518|OTHER|||||||0.02|||||||ANOVA|||DF2188Y, Cmax, Day 1||||0.0200
70906453|NCT02001974|141302518|OTHER|||||||0.2134|||||||ANOVA|||DF2188Y, Cmax, Day 1||||0.2134
70906454|NCT02001974|141302518|OTHER|||||||0.0235|||||||ANOVA|||DF2188Y, Cmax, Day 8||||0.0235
70906455|NCT02001974|141302518|OTHER|||||||0.0964|||||||ANOVA|||DF2188Y, Cmax, Day 8||||0.0964
70906456|NCT02001974|141302518|OTHER|||||||0.0314|||||||ANOVA|||DF2188Y, Cmax, Day 21||||0.0314
70906457|NCT02001974|141302518|OTHER|||||||0.0773|||||||ANOVA|||DF2188Y, Cmax, Day 21||||0.0773
70906458|NCT02001974|141302519|OTHER|||||||0.1016|||||||ANOVA|||Cmax, ibuprofen, Day -3||||0.1016
70906459|NCT02001974|141302519|OTHER|||||||0.2001|||||||ANOVA|||Cmax, ibuprofen, Day -3||||0.2001
70906460|NCT02001974|141302519|OTHER|||||||0.0802|||||||ANOVA|||Cmax, ibuprofen, Day 1||||0.0802
70906461|NCT02001974|141302519|OTHER|||||||0.4728|||||||ANOVA|||Cmax, ibuprofen, Day 1||||0.4728
70906462|NCT02001974|141302519|OTHER|||||||0.0355|||||||ANOVA|||Cmax, ibuprofen, Day 8||||0.0355
70906463|NCT02001974|141302519|OTHER|||||||0.1709|||||||ANOVA|||Cmax, ibuprofen, Day 8||||0.1709
70906464|NCT02001974|141302519|OTHER|||||||0.0685|||||||ANOVA|||Cmax, ibuprofen, Day 21||||0.0685
70906465|NCT02001974|141302519|OTHER|||||||0.3189|||||||ANOVA|||Cmax, ibuprofen, Day 21||||0.3189
70906466|NCT02001974|141302520|OTHER|||||||0.2375|||||||ANOVA|||Paclitaxel, Cmax, Day 1||||0.2375
70906467|NCT02001974|141302520|OTHER|||||||0.3608|||||||ANOVA|||Cmax, ibuprofen, Day 1||||0.3608
70906468|NCT02001974|141302520|OTHER|||||||0.0442|||||||ANOVA|||Cmax, ibuprofen, Day 8||||0.0442
70906469|NCT02001974|141302520|OTHER|||||||0.1067|||||||ANOVA|||Cmax, ibuprofen, Day 8||||0.1067
70906470|NCT02001974|141302526|OTHER|||||||0.0134|||||||ANOVA|||DF1681Y, AUC0-8, Day -3||||0.0134
70906471|NCT02001974|141302526|OTHER|||||||0.0799|||||||ANOVA|||DF1681Y, AUC0-8, Day -3||||0.0799
70906472|NCT02001974|141302526|OTHER|||||||0.0241|||||||ANOVA|||DF1681Y, AUC0-8, Day 1||||0.0241
70906473|NCT02001974|141302526|OTHER|||||||0.01384|||||||ANOVA|||DF1681Y, AUC0-8, Day 1||||0.01384
70906474|NCT02001974|141302526|OTHER|||||||0.0091|||||||ANOVA|||DF1681Y, AUC0-8, Day 8||||0.0091
70906475|NCT02001974|141302526|OTHER|||||||0.5687|||||||ANOVA|||DF1681Y, AUC0-8, Day 8||||0.5687
70906476|NCT02001974|141302526|OTHER|||||||0.0058|||||||ANOVA|||DF1681Y, AUC0-8, Day 21||||0.0058
70906477|NCT02001974|141302526|OTHER|||||||0.3667|||||||ANOVA|||DF1681Y, AUC0-8, Day 21||||0.3667
70906478|NCT02001974|141302527|OTHER|||||||0.0029|||||||ANOVA|||DF2243Y - AUC0-8 - Day -3||||0.0029
70906479|NCT02001974|141302527|OTHER|||||||0.0349|||||||ANOVA|||DF2243Y - AUC0-8 - Day -3||||0.0349
70906480|NCT02001974|141302527|OTHER|||||||0.0119|||||||ANOVA|||DF2243Y - AUC0-8 - Day 1||||0.0119
70906481|NCT02001974|141302527|OTHER|||||||0.21|||||||ANOVA|||DF2243Y - AUC0-8 - Day 1||||0.2100
70906482|NCT02001974|141302527|OTHER|||||||0.0165|||||||ANOVA|||DF2243Y - AUC0-8 - Day 8||||0.0165
70906483|NCT02001974|141302527|OTHER|||||||0.1496|||||||ANOVA|||DF2243Y - AUC0-8 - Day 8||||0.1496
70906484|NCT02001974|141302527|OTHER|||||||0.0321|||||||ANOVA|||DF2243Y - AUC0-8 - Day 21||||0.0321
70906485|NCT02001974|141302527|OTHER|||||||0.1404|||||||ANOVA|||DF2243Y - AUC0-8 - Day 21||||0.1404
70906486|NCT02001974|141302528|OTHER|||||||0.0081|||||||ANOVA|||AUC0-8 for DF2188Y, Day -3||||0.0081
70906487|NCT02001974|141302528|OTHER|||||||0.064|||||||ANOVA|||AUC0-8 for DF2188Y, Day -3||||0.0640
70906488|NCT02001974|141302528|OTHER|||||||0.0397|||||||ANOVA|||AUC0-8 for DF2188Y, Day 1||||0.0397
70906489|NCT02001974|141302528|OTHER|||||||0.1898|||||||ANOVA|||AUC0-8 for DF2188Y, Day 1||||0.1898
70906490|NCT02001974|141302528|OTHER|||||||0.025|||||||ANOVA|||AUC0-8 for DF2188Y, Day 8||||0.0250
70906491|NCT02001974|141302528|OTHER|||||||0.1605|||||||ANOVA|||AUC0-8 for DF2188Y, Day 8||||0.1605
70906492|NCT02001974|141302528|OTHER|||||||0.0786|||||||ANOVA|||AUC0-8 for DF2188Y, Day 21||||0.0786
70906493|NCT02001974|141302528|OTHER|||||||0.2652|||||||ANOVA|||AUC0-8 for DF2188Y, Day 21||||0.2652
70906494|NCT02001974|141302529|OTHER|||||||0.1335|||||||ANOVA|||Ibuprofen, AUC0-8, Day -3||||0.1335
70906495|NCT02001974|141302529|OTHER|||||||0.2658|||||||ANOVA|||Ibuprofen, AUC0-8, Day -3||||0.2658
70906496|NCT02001974|141302529|OTHER|||||||0.1063|||||||ANOVA|||Ibuprofen, AUC0-8, Day 1||||0.1063
70906497|NCT02001974|141302529|OTHER|||||||0.4959|||||||ANOVA|||Ibuprofen, AUC0-8, Day 1||||0.4959
70906498|NCT02001974|141302529|OTHER|||||||0.0452|||||||ANOVA|||Ibuprofen, AUC0-8, Day 8||||0.0452
70906499|NCT02001974|141302529|OTHER|||||||0.2223|||||||ANOVA|||Ibuprofen, AUC0-8, Day 8||||0.2223
70906500|NCT02001974|141302529|OTHER|||||||0.0737|||||||ANOVA|||Ibuprofen, AUC0-8, Day 21||||0.0737
70906501|NCT02001974|141302529|OTHER|||||||0.2804|||||||ANOVA|||Ibuprofen, AUC0-8, Day21||||0.2804
70906502|NCT02001974|141302530|OTHER|||||||0.1449|||||||ANOVA|||Paclitaxel, AUC0-8, Day 1||||0.1449
70906503|NCT02001974|141302530|OTHER|||||||0.1338|||||||ANOVA|||Ibuprofen, AUC0-8, Day 1||||0.1338
70906504|NCT02001974|141302530|OTHER|||||||0.0633|||||||ANOVA|||Ibuprofen, AUC0-8, Day 8||||0.0633
70906505|NCT02001974|141302530|OTHER|||||||0.6939|||||||ANOVA|||Ibuprofen, AUC0-8, Day 8||||0.6939
70906506|NCT00672958|141302541|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.74||||0.407|TWO_SIDED|95.0|-2.48|1.01||Pre-specified sequential statistical testing procedure indicates that when p-value for change from baseline in HAMD-24 at Week 6 \>0.05, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|ANCOVA|Analysis of covariance (ANCOVA), with treatment and center as fixed factors and baseline HAM-D24 as a covariate.||Change from Baseline in HAM-D24 total score at Week 6 was tested at significance level 0.05. To control for multiplicity, subsequent endpoints were to be tested in a sequential testing procedure at significance level 0.025; as soon as an endpoint in a sequence was non-significant at 0.025, the testing procedure was stopped for all subsequent endpoints in that sequence.||1.01|-2.48|0.407
70906507|NCT00672958|141302542|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07||||0.901|TWO_SIDED|95.0|-0.97|1.1|||ANCOVA|ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.||Comparison of change from Baseline at Week 1.||1.10|-0.97|0.901
70906508|NCT00672958|141302542|SUPERIORITY_OR_OTHER||LS Mean Difference|0.26||||0.701|TWO_SIDED|95.0|-1.07|1.59|||ANCOVA|ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.||Change from Baseline at Week 2||1.59|-1.07|0.701
70906509|NCT00672958|141302542|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.68||||0.356|TWO_SIDED|95.0|-2.11|0.76|||ANCOVA|ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.||Change from Baseline at Week 3||0.76|-2.11|0.356
70906510|NCT00672958|141302542|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.33||||0.67|TWO_SIDED|95.0|-1.85|1.19|||ANCOVA|ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.||Change from Baseline at Week 4||1.19|-1.85|0.670
70906511|NCT00672958|141302542|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.87||||0.304|TWO_SIDED|95.0|-2.52|0.79|||ANCOVA|ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.||Change from Baseline at Week 5||0.79|-2.52|0.304
70906512|NCT01380990|141302554|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients alive at 1-year post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study subjects.||||
70906513|NCT01380990|141302554|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients alive at 1-year post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study subjects.||||
70906514|NCT01380990|141302554|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients alive at 1-year post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study subjects.||||
70906515|NCT01380990|141302554|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (without MRD) were compared to the percentage of patients alive at 1-year post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study and CUP subjects.||||
70906516|NCT01380990|141302554|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (with MRD) were compared to the percentage of patients alive at 1-year post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study and CUP subjects.||||
70906517|NCT01380990|141302554|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (all historical controls) were compared to the percentage of patients alive at 1-year post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study and CUP subjects.||||
70906518|NCT01380990|141302555|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study subjects.||||
70906519|NCT01380990|141302555|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study subjects.||||
70906520|NCT01380990|141302555|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study subjects.||||
70906521|NCT01380990|141302555|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study and CUP subjects.||||
70906522|NCT01380990|141302555|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study and CUP subjects.||||
70906523|NCT01380990|141302555|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study and CUP subjects.||||
70906524|NCT01380990|141302560|OTHER|Model includes fixed effects for visit and Baseline, subject as random effect, with compound symmetry covariance structure. Observations with a value of 0 were imputed as 0.01. Model analyses log transformed data, so the adjusted mean refers to the geometric mean ratio between Month 12 and Baseline.|||||=|0.002|||||||Mixed Models Analysis|||"Mixed-Effect Model Repeated Measure (MMRM) Analysis of Change from Baseline to Month 12 in Log-Transformed CD3+ T Cell count (OTL-101\*) for OTL-101\* on-study subjects group."||||= 0.002
70906525|NCT01380990|141302560|OTHER|Model includes fixed effects for visit and Baseline, subject as random effect, with compound symmetry covariance structure. Observations with a value of 0 were imputed as 0.01. Model analyses log transformed data, so the adjusted mean refers to the geometric mean ratio between Month 12 and Baseline.|||||<|0.001|||||||Mixed Models Analysis|||"MMRM Analysis of Change from Baseline to Month 12 in Log-Transformed CD3+ T Cell count (OTL-101\*) for OTL-101\* on-study and CUP subjects group."||||< 0.001
70906526|NCT01380990|141302565|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with OS at 3-years post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with OS at 3-years post-treatment with OTL-101\* (on study). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study subjects.||||
70906527|NCT01380990|141302565|SUPERIORITY||Difference in percentages|11.11|||||TWO_SIDED|95.0|-22.41|48.25||||||Percentage of patients with OS at 3-years post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with OS at 3-years post-treatment with OTL-101\* (on study). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study subjects.||48.25|-22.41|
70906528|NCT01380990|141302565|SUPERIORITY||Difference in percentages|7.14|||||TWO_SIDED|95.0|-28.1|34.23||||||Percentage of patients with OS at 3-years post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients with OS at 3-years post-treatment with OTL-101\* (on study). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study subjects.||34.23|-28.10|
70906529|NCT01380990|141302565|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with OS at 3-years post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with OS at 3-years post-treatment with OTL-101\* (on study and CUP). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study and CUP subjects.||||
70906530|NCT01380990|141302565|SUPERIORITY||Difference in percentages|11.11|||||TWO_SIDED|95.0|-10.01|48.25||||||Percentage of patients with OS at 3-years post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with OS at 3-years post-treatment with OTL-101\* (on study and CUP). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study and CUP subjects.||48.25|-10.01|
70906531|NCT01380990|141302565|SUPERIORITY||Difference in percentages|7.14|||||TWO_SIDED|95.0|-12.91|33.87||||||Percentage of patients with OS at 3-years post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients with OS at 3-years post-treatment with OTL-101\* (on study and CUP). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study and CUP subjects.||33.87|-12.91|
70906532|NCT01380990|141302566|SUPERIORITY||||||=|0.645|||||||Log Rank|||||||=0.645
70906533|NCT01380990|141302566|SUPERIORITY||||||=|0.299|||||||Log Rank|||||||=0.299
70906534|NCT01380990|141302566|SUPERIORITY||||||=|0.2|||||||Log Rank|||||||= 0.2
70906535|NCT01380990|141302566|SUPERIORITY||||||=|0.028|||||||Log Rank|||||||= 0.028
70906536|NCT01380990|141302566|SUPERIORITY||||||=|0.259|||||||Log Rank|||||||= 0.259
70906537|NCT01380990|141302566|SUPERIORITY||||||=|0.044|||||||Log Rank|||||||= 0.044
70906538|NCT01380990|141302566|SUPERIORITY||Difference in percentages|10.0|||||TWO_SIDED|95.0|-32.05|61.97||||||Percentage of patients with EvFS at 3-years post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with EvFS at 3-years post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study subjects.||61.97|-32.05|
70906539|NCT01380990|141302566|SUPERIORITY||Difference in percentages|30.0|||||TWO_SIDED|95.0|-10.72|65.87||||||Percentage of patients with EvFS at 3-years post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with EvFS at 3-years post treatment with OTL-101\* (on-study). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study subjects.||65.87|-10.72|
70906540|NCT01380990|141302566|SUPERIORITY||Difference in percentages|23.33|||||TWO_SIDED|95.0|-15.24|54.59||||||Percentage of patients with EvFS at 3-years post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients with EvFS at 3-years post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study subjects.||54.59|-15.24|
70906541|NCT01380990|141302566|SUPERIORITY||Difference in percentages|15.0|||||TWO_SIDED|95.0|-13.7|63.54||||||Percentage of patients with EvFS at 3-years post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with EvFS at 3-years post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study and CUP subjects.||63.54|-13.70|
70906542|NCT01380990|141302566|SUPERIORITY||Difference in percentages|35.0|||||TWO_SIDED|95.0|2.29|68.45||||||Percentage of patients with EvFS at 3-years post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with EvFS at 3-years post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study and CUP subjects.||68.45|2.29|
70906543|NCT01380990|141302566|SUPERIORITY||Difference in percentages|28.33|||||TWO_SIDED|95.0|2.04|56.36||||||Percentage of patients with EvFS at 3-years post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients with EvFS at 3-years post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study and CUP subjects.||56.36|2.04|
70906544|NCT04267614|141302574|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70906545|NCT04267614|141302575|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70906546|NCT04267614|141302576|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70906547|NCT04267614|141302577|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
70906548|NCT04827134|141302580|OTHER||Ratio of Geometric Least Square Means|0.88|||||TWO_SIDED|90.0|0.8344|0.9282|||||An analysis of variance (ANOVA) was performed on parameter AUC(0-inf) for Analyte DTG to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.9282|0.8344|
70906549|NCT04827134|141302580|OTHER||Ratio of Geometric Least Square Means|0.8578|||||TWO_SIDED|90.0|0.8168|0.9007|||||An analysis of variance was performed on parameter AUC(0-inf) for Analyte ABC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.9007|0.8168|
70906550|NCT04827134|141302580|OTHER||Ratio of Geometric Least Square Means|0.8919|||||TWO_SIDED|90.0|0.8316|0.9566|||||An analysis of variance was performed on parameter AUC(0-inf) for Analyte 3TC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.9566|0.8316|
70906551|NCT04827134|141302581|OTHER||Ratio of Geometric Least Square Means|0.8744|||||TWO_SIDED|90.0|0.8293|0.9219|||||An analysis of variance was performed on parameter AUC(0-t) for Analyte DTG to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.9219|0.8293|
70906552|NCT04827134|141302581|OTHER||Ratio of Geometric Least Square Means|0.8567|||||TWO_SIDED|90.0|0.8159|0.8995|||||An analysis of variance was performed on parameter AUC(0-t) for Analyte ABC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.8995|0.8159|
70906553|NCT04827134|141302581|OTHER||Ratio of Geometric Least Square Means|0.8798|||||TWO_SIDED|90.0|0.8202|0.9438|||||An analysis of variance was performed on parameter AUC(0-t) for Analyte 3TC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.9438|0.8202|
70906554|NCT04827134|141302582|OTHER||Ratio of Geometric Least Square Means|0.7102|||||TWO_SIDED|90.0|0.6598|0.7643|||||An analysis of variance was performed on parameter Cmax for Analyte DTG to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.7643|0.6598|
70906555|NCT04827134|141302582|OTHER||Ratio of Geometric Least Square Means|0.4503|||||TWO_SIDED|90.0|0.3976|0.51|||||An analysis of variance was performed on parameter Cmax for Analyte ABC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.5100|0.3976|
70906556|NCT04827134|141302582|OTHER||Ratio of Geometric Least Square Means|0.6373|||||TWO_SIDED|90.0|0.5594|0.726|||||An analysis of variance was performed on parameter Cmax for Analyte 3TC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.7260|0.5594|
70906557|NCT04827134|141302583|OTHER||Ratio of Geometric Least Square Means|0.9148|||||TWO_SIDED|90.0|0.8834|0.9472|||||An analysis of variance was performed on parameter AUC(0-inf) for Analyte DTG to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.|||0.9472|0.8834|
70906558|NCT04827134|141302583|OTHER||Ratio of Geometric Least Square Means|0.8847|||||TWO_SIDED|90.0|0.8303|0.9426|||||An analysis of variance was performed on parameter AUC(0-inf) for Analyte 3TC to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.|||0.9426|0.8303|
70906559|NCT04827134|141302584|OTHER||Ratio of Geometric Least Square Means|0.9163|||||TWO_SIDED|90.0|0.8862|0.9475|||||An analysis of variance was performed on parameter AUC(0-t) for Analyte DTG to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.|||0.9475|0.8862|
70906560|NCT04827134|141302584|OTHER||Ratio of Geometric Least Square Means|0.8806|||||TWO_SIDED|90.0|0.8251|0.9398|||||An analysis of variance was performed on parameter AUC(0-t) for Analyte 3TC to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.|||0.9398|0.8251|
70906561|NCT04827134|141302585|OTHER||Ratio of Geometric Least Square Means|0.7284|||||TWO_SIDED|90.0|0.6576|0.8068|||||An analysis of variance was performed on parameter Cmax for Analyte DTG to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.|||0.8068|0.6576|
70906562|NCT04827134|141302585|OTHER||Ratio of Geometric Least Square Means|0.5191|||||TWO_SIDED|90.0|0.4535|0.5943|||||An analysis of variance was performed on parameter Cmax for Analyte 3TC to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.|||0.5943|0.4535|
70906563|NCT00988351|141302652|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin -0.55 (mean hours of APAP arm no lower than 0.55 hours below CPAP arm)|Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.4|=|0.27|TWO_SIDED|95.0|-0.35|1.26||level of significance \<0.05, Power = 0.80|t-test, 2 sided|||||1.26|-.35|= 0.27
70906564|NCT00988351|141302653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||=|0.65|TWO_SIDED|95.0|-1.3|2.1|||t-test, 2 sided|||Patients using PAP (average of \>=1/2 hour per night) at 6 weeks clinic visit||2.1|-1.3|= 0.65
70906565|NCT00988351|141302654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.71|=|0.33|TWO_SIDED|95.0|-0.73|2.1||\< 0.05 criteria for statistical significance|t-test, 2 sided|||Patients using PAP (average \>=1/2 hour per nightly use) at 6 weeks clinic visit||2.1|-0.73|=0.33
70906566|NCT00988351|141302655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|||=|0.49|TWO_SIDED|95.0|-1.12|2.29|||t-test, 2 sided|||Patients using PAP (average \>= 1/2 hour of nightly use) at 6 weeks clinic visit||2.29|-1.12|=0.49
70906567|NCT00988351|141302656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.51|=|0.07|TWO_SIDED|95.0|-1.92|0.09||P \< 0.05 considered statistically significant|t-test, 2 sided|||participants using PAP (average \>=1/2 hour of use) at 6 weeks clinic visit||0.09|-1.92|=0.07
70906568|NCT04844918|141302682|SUPERIORITY||LS Mean Difference|-16.1|||<|0.001|TWO_SIDED|95.0|-18.7|-13.5|||Mixed Models Analysis|||||-13.5|-18.7|<0.001
70906569|NCT04844918|141302682|SUPERIORITY||LS Mean Difference|-21.1|||<|0.001|TWO_SIDED|95.0|-23.6|-18.5|||Mixed Models Analysis|||||-18.5|-23.6|<0.001
70906570|NCT04844918|141302683|SUPERIORITY||Odds Ratio (OR)|119.65|||<|0.001|TWO_SIDED|95.0|29.06|492.67|||Mixed Models Analysis|||||492.67|29.06|<0.001
70906571|NCT04844918|141302683|SUPERIORITY||Odds Ratio (OR)|153.57|||<|0.001|TWO_SIDED|95.0|36.03|654.53|||Mixed Models Analysis|||||654.53|36.03|<0.001
70906572|NCT04844918|141302684|SUPERIORITY||Odds Ratio (OR)|24.26|||<|0.001|TWO_SIDED|95.0|8.62|68.28|||Regression, Logistic|||||68.28|8.62|<0.001
70906573|NCT04844918|141302684|SUPERIORITY||Odds Ratio (OR)|38.27|||<|0.001|TWO_SIDED|95.0|13.21|110.89|||Regression, Logistic|||||110.89|13.21|<0.001
70906574|NCT04844918|141302685|SUPERIORITY||LS Mean Difference|-15.0|||<|0.001|TWO_SIDED|95.0|-18.91|-11.09|||Mixed Models Analysis|||||-11.09|-18.91|<0.001
70906575|NCT04844918|141302685|SUPERIORITY||LS Mean Difference|-12.8|||<|0.001|TWO_SIDED|95.0|-16.56|-9.05|||Mixed Models Analysis|||||-9.05|-16.56|<0.001
70906576|NCT04844918|141302686|SUPERIORITY||LS Mean Difference|-55.76|||<|0.001|TWO_SIDED|95.0|-69.74|-41.77|||Mixed Models Analysis|||||-41.77|-69.74|<0.001
70906577|NCT04844918|141302686|SUPERIORITY||LS Mean Difference|-64.82|||<|0.001|TWO_SIDED|95.0|-78.2|-51.43|||Mixed Models Analysis|||||-51.43|-78.20|<0.001
70906578|NCT04844918|141302687|SUPERIORITY||LS Mean Difference|-40.7|||<|0.001|TWO_SIDED|95.0|-50.0|-29.7|||Mixed Models Analysis|||||-29.7|-50.0|<0.001
70906579|NCT04844918|141302687|SUPERIORITY||LS Mean Difference|-44.5|||<|0.001|TWO_SIDED|95.0|-52.7|-34.9|||Mixed Models Analysis|||||-34.9|-52.7|<0.001
70906580|NCT04844918|141302688|SUPERIORITY||LS Mean Difference|-44.4|||<|0.001|TWO_SIDED|95.0|-53.0|-35.7|||ANCOVA|||||-35.7|-53.0|<0.001
70906581|NCT04844918|141302688|SUPERIORITY||LS Mean Difference|-50.4|||<|0.001|TWO_SIDED|95.0|-58.8|-41.9|||ANCOVA|||||-41.9|-58.8|<0.001
70906582|NCT04844918|141302689|SUPERIORITY||Odds Ratio (OR)|25.42|||<|0.001|TWO_SIDED|95.0|7.25|89.14|||Regression, Logistic|||||89.14|7.25|<0.001
70906583|NCT04844918|141302689|SUPERIORITY||Odds Ratio (OR)|70.66|||<|0.001|TWO_SIDED|95.0|12.73|392.24|||Regression, Logistic|||||392.24|12.73|<0.001
70906584|NCT04844918|141302690|SUPERIORITY||Odds Ratio (OR)|9.29|||<|0.001|TWO_SIDED|95.0|2.86|30.2|||Regression, Logistic|||||30.20|2.86|<0.001
70906585|NCT04844918|141302690|SUPERIORITY||Odds Ratio (OR)|15.67|||<|0.001|TWO_SIDED|95.0|4.78|51.37|||Regression, Logistic|||||51.37|4.78|<0.001
70906586|NCT04844918|141302691|SUPERIORITY||Odds Ratio (OR)|27.5|||<|0.001|TWO_SIDED|95.0|9.35|80.88|||Regression, Logistic|||||80.88|9.35|<0.001
70906587|NCT04844918|141302691|SUPERIORITY||Odds Ratio (OR)|40.01|||<|0.001|TWO_SIDED|95.0|13.27|120.57|||Regression, Logistic|||||120.57|13.27|<0.001
70906588|NCT04844918|141302692|SUPERIORITY||Odds Ratio (OR)|185.92|||<|0.001|TWO_SIDED|95.0|46.39|745.16|||Regression, Logistic|||||745.16|46.39|<0.001
70906589|NCT04844918|141302692|SUPERIORITY||Odds Ratio (OR)|318.02|||<|0.001|TWO_SIDED|95.0|74.49|1357.79|||Regression, Logistic|||||1357.79|74.49|<0.001
70906590|NCT04844918|141302693|SUPERIORITY||Odds Ratio (OR)|100.21|||<|0.001|TWO_SIDED|95.0|18.64|538.74|||Regression, Logistic|||||538.74|18.64|<0.001
70906591|NCT04844918|141302693|SUPERIORITY||Odds Ratio (OR)|286.73|||<|0.001|TWO_SIDED|95.0|50.68|1622.06|||Regression, Logistic|||||1622.06|50.68|<0.001
70906592|NCT04844918|141302694|SUPERIORITY||LS Mean Difference|-14.5|||<|0.001|TWO_SIDED|95.0|-16.8|-12.2|||Mixed Models Analysis|||||-12.2|-16.8|<0.001
70906593|NCT04844918|141302694|SUPERIORITY||LS Mean Difference|-19.3|||<|0.001|TWO_SIDED|95.0|-21.6|-17.0|||Mixed Models Analysis|||||-17.0|-21.6|<0.001
70906594|NCT04844918|141302695|SUPERIORITY||LS Mean Difference|-5.2|||<|0.001|TWO_SIDED|95.0|-6.1|-4.4|||Mixed Models Analysis|||||-4.4|-6.1|<0.001
70906595|NCT04844918|141302695|SUPERIORITY||LS Mean Difference|-7.1|||<|0.001|TWO_SIDED|95.0|-8.0|-6.3|||Mixed Models Analysis|||||-6.3|-8.0|<0.001
70906596|NCT04844918|141302696|SUPERIORITY||LS Mean Difference|-36.1|||<|0.001|TWO_SIDED|95.0|-42.9|-29.3|||Mixed Models Analysis|||||-29.3|-42.9|<0.001
70906597|NCT04844918|141302696|SUPERIORITY||LS Mean Difference|-41.1|||<|0.001|TWO_SIDED|95.0|-47.8|-34.4|||Mixed Models Analysis|||||-34.4|-47.8|<0.001
70906598|NCT04844918|141302697|SUPERIORITY||LS Mean Difference|-27.2|||<|0.001|TWO_SIDED|95.0|-32.6|-21.9|||Mixed Models Analysis|||||-21.9|-32.6|<0.001
70906599|NCT04844918|141302697|SUPERIORITY||LS Mean Difference|-31.5|||<|0.001|TWO_SIDED|95.0|-36.7|-26.2|||Mixed Models Analysis|||||-26.2|-36.7|<0.001
70906600|NCT04844918|141302698|SUPERIORITY||LS Mean Difference|-0.1||||0.004|TWO_SIDED|95.0|-0.16|-0.03|||Mixed Models Analysis|||||-0.03|-0.16|0.004
70906601|NCT04844918|141302698|SUPERIORITY||LS Mean Difference|-0.09||||0.006|TWO_SIDED|95.0|-0.15|-0.03|||Mixed Models Analysis|||||-0.03|-0.15|0.006
70906602|NCT04844918|141302699|SUPERIORITY||Odds Ratio (OR)|28.52|||<|0.001|TWO_SIDED|95.0|4.31|188.55|||Regression, Logistic|||||188.55|4.31|<0.001
70906603|NCT04844918|141302699|SUPERIORITY||Odds Ratio (OR)|57.73|||<|0.001|TWO_SIDED|95.0|8.68|383.88|||Regression, Logistic|||||383.88|8.68|<0.001
70906604|NCT04844918|141302700|SUPERIORITY||LS Mean Difference|-11.4|||<|0.001|TWO_SIDED|95.0|-13.8|-9.0|||Mixed Models Analysis|||||-9.0|-13.8|<0.001
70906605|NCT04844918|141302700|SUPERIORITY||LS Mean Difference|-15.3|||<|0.001|TWO_SIDED|95.0|-17.7|-13.0|||Mixed Models Analysis|||||-13.0|-17.7|<0.001
70906606|NCT04844918|141302701|SUPERIORITY||LS Mean Difference|-0.65|||<|0.001|TWO_SIDED|95.0|-0.77|-0.53|||Mixed Models Analysis|||||-0.53|-0.77|<0.001
70906607|NCT04844918|141302701|SUPERIORITY||LS Mean Difference|-0.66|||<|0.001|TWO_SIDED|95.0|-0.77|-0.55|||Mixed Models Analysis|||||-0.55|-0.77|<0.001
70906608|NCT04844918|141302702|SUPERIORITY||LS Mean Difference|-3.91|||||TWO_SIDED|95.0|-5.74|-2.08||||||||-2.08|-5.74|
70906609|NCT04844918|141302702|SUPERIORITY||LS Mean Difference|-4.55|||||TWO_SIDED|95.0|-6.29|-2.81||||||||-2.81|-6.29|
70906610|NCT04844918|141302703|SUPERIORITY||LS Mean Difference|-13.2|||<|0.001|TWO_SIDED|95.0|-17.0|-9.3|||Mixed Models Analysis|||||-9.3|-17.0|<0.001
70906611|NCT04844918|141302703|SUPERIORITY||LS Mean Difference|-13.9|||<|0.001|TWO_SIDED|95.0|-17.7|-10.1|||Mixed Models Analysis|||||-10.1|-17.7|<0.001
70906612|NCT04844918|141302704|SUPERIORITY||LS Mean Difference|-6.3|||<|0.001|TWO_SIDED|95.0|-9.3|-3.4|||Mixed Models Analysis|||||-3.4|-9.3|<0.001
70906613|NCT04844918|141302704|SUPERIORITY||LS Mean Difference|-6.8|||<|0.001|TWO_SIDED|95.0|-9.7|-3.9|||Mixed Models Analysis|||||-3.9|-9.7|<0.001
70906614|NCT04844918|141302705|SUPERIORITY||LS Mean Difference|1.3||||0.022|TWO_SIDED|95.0|0.2|2.3|||ANCOVA|||||2.3|0.2|0.022
70906615|NCT04844918|141302705|SUPERIORITY||LS Mean Difference|2.1|||<|0.001|TWO_SIDED|95.0|1.1|3.2|||ANCOVA|||||3.2|1.1|<0.001
70906616|NCT04844918|141302706|SUPERIORITY||LS Mean Difference|13.0|||<|0.001|TWO_SIDED|95.0|7.4|18.7|||ANCOVA|||||18.7|7.4|<0.001
70906617|NCT04844918|141302706|SUPERIORITY||LS Mean Difference|10.8|||<|0.001|TWO_SIDED|95.0|5.4|16.3|||ANCOVA|||||16.3|5.4|<0.001
70906618|NCT04844918|141302707|SUPERIORITY||LS Mean Difference|0.03||||0.099|TWO_SIDED|95.0|0.0|0.06|||ANCOVA|||||0.06|0.00|0.099
70906619|NCT04844918|141302707|SUPERIORITY||LS Mean Difference|0.02||||0.236|TWO_SIDED|95.0|-0.01|0.05|||ANCOVA|||||0.05|-0.01|0.236
70906620|NCT00183456|141302709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.28|||<|0.01|TWO_SIDED|95.0|0.13|0.63|||Generalized Estimating Equations|||||0.63|0.13|<0.01
70906621|NCT00183456|141302710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.68||||0.05|TWO_SIDED|95.0|1.22|5.89|||Generalized Estimating Equations|||||5.89|1.22|0.05
70906622|NCT00183456|141302711|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.05|TWO_SIDED|95.0|0.16|0.84|||Generalized Estimating Equations|||||0.84|0.16|0.05
70906623|NCT00183456|141302712|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.82||||0.01|TWO_SIDED|95.0|1.41|5.64|||Generalized Estimating Equations|||||5.64|1.41|0.01
70906624|NCT00183456|141302713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.24||||0.01|TWO_SIDED|95.0|0.09|0.68|||Generalized Estimating Equations|||||0.68|0.09|0.01
70906625|NCT00183456|141302714|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.05|TWO_SIDED|95.0|0.25|0.87|||Generalized Estimating Equations|||||0.87|0.25|0.05
70906626|NCT00183456|141302715|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41||||0.01|TWO_SIDED|95.0|0.21|0.77|||Generalized Estimating Equations|||||0.77|0.21|0.01
70906627|NCT00183456|141302716|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.33||||0.05|TWO_SIDED|95.0|0.14|0.79|||Generalized Estimating Equations|||||0.79|0.14|0.05
70906628|NCT00183456|141302717|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3||||0.01|TWO_SIDED|95.0|0.14|0.64|||Generalized Estimating Equations|||||0.64|0.14|0.01
70906629|NCT00183456|141302718|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.41||||0.01|TWO_SIDED|95.0|1.25|4.65|||Generalized Estimating Equations|||||4.65|1.25|0.01
70906630|NCT02731313|141302719|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis (H0): kappa coefficient = 0.90||||||0.7436|||||||Kappa-test p-value, 2 sided|||Rationale for the determination of the number of samples:The following hypotheses were considered: two-sided risk alpha = 5%, power (1 - beta) = 90%, a success rate (rate of positive HER-2 status) = 17%, null hypothesis (H0): kappa coefficient = 0.90. 359 samples would allow determining a first estimate of the 0.90 coefficient of correlation kappa. The total number of samples, which had to be included in this study was 395, considering a 10% rate of non-evaluable samples.||||0.7436
70906631|NCT02743793|141302747|OTHER|No test was performed.|Kaplan-Meier survival estimate|64.0|||||TWO_SIDED|95.0|21.3|87.9|||||Percent of participants that remained tolerant during study participation.|||87.9|21.3|
70906632|NCT02065570|141302751|SUPERIORITY||Adjusted risk difference|0.3||||0.939|TWO_SIDED|95.0|-8.1|8.8||Adjusted for previous infliximab use (or prior anti-tumor necrosis factor (TNF) use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||8.8|-8.1|0.939
70906633|NCT02065570|141302752|SUPERIORITY||Adjusted risk difference|3.2||||0.462|TWO_SIDED|95.0|-5.3|11.7||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||11.7|-5.3|0.462
70906634|NCT02065570|141302754|SUPERIORITY||Adjusted risk difference|4.6||||0.269|TWO_SIDED|95.0|-3.6|12.8||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||12.8|-3.6|0.269
70906635|NCT02065570|141302755|SUPERIORITY||Adjusted risk difference|1.8||||0.61|TWO_SIDED|95.0|-5.1|8.7||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||8.7|-5.1|0.610
70906636|NCT02065570|141302756|SUPERIORITY||Adjusted risk difference|11.2||||0.008|TWO_SIDED|95.0|2.9|19.6||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||19.6|2.9|0.008
70906637|NCT02065570|141302757|SUPERIORITY||Adjusted risk difference|6.0||||0.336|TWO_SIDED|95.0|-6.2|18.2||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||18.2|-6.2|0.336
70906638|NCT02065570|141302758|SUPERIORITY||Adjusted risk difference|1.5||||0.694|TWO_SIDED|95.0|-6.1|9.1||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||9.1|-6.1|0.694
70906639|NCT02065570|141302759|SUPERIORITY||LS Mean of Difference|6.8||||0.946|TWO_SIDED|95.0|-192.3|205.9|||Cochran-Mantel-Haenszel|||||205.9|-192.3|0.946
70906640|NCT02065570|141302760|SUPERIORITY||Adjusted risk difference|4.0||||0.293|TWO_SIDED|95.0|-3.5|11.5||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||11.5|-3.5|0.293
70906641|NCT02065570|141302761|SUPERIORITY||Adjusted risk difference|3.0||||0.304|TWO_SIDED|95.0|-2.7|8.6||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||8.6|-2.7|0.304
70967411|NCT01431274|141440929|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.036|STANDARD_ERROR_OF_MEAN|0.026||0.1615|TWO_SIDED|95.0|-0.014|0.086||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.086|-0.014|0.1615
70906642|NCT02065570|141302762|SUPERIORITY||Adjusted risk difference|4.2||||0.092|TWO_SIDED|95.0|-0.7|9.1||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||9.1|-0.7|0.092
70906643|NCT02065570|141302763|SUPERIORITY||Adjusted risk difference|3.6||||0.278|TWO_SIDED|95.0|-2.9|10.2||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||10.2|-2.9|0.278
70906644|NCT02065570|141302764|SUPERIORITY||Adjusted risk difference|3.7||||0.353|TWO_SIDED|95.0|-4.1|11.5||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||11.5|-4.1|0.353
70906645|NCT02065570|141302765|SUPERIORITY||Adjusted risk difference|8.9||||0.015|TWO_SIDED|95.0|1.8|16.0||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||16.0|1.8|0.015
70906646|NCT02065570|141302766|SUPERIORITY||Adjusted risk difference|3.4||||0.394|TWO_SIDED|95.0|-4.4|11.1||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||11.1|-4.4|0.394
70906647|NCT02065570|141302767|SUPERIORITY||Adjusted risk difference|3.6||||0.349|TWO_SIDED|95.0|-4.0|11.2||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose)|||11.2|-4.0|0.349
70906648|NCT02065570|141302768|SUPERIORITY||Adjusted risk difference|7.6||||0.054|TWO_SIDED|95.0|-0.1|15.3||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose)|||15.3|-0.1|0.054
70906649|NCT02293837|141302772|SUPERIORITY|||||||0.277||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52; Primary imputation method used for missing Week 52 mAUC.||||0.277
70906650|NCT02293837|141302773|SUPERIORITY|||||||0.499||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 24||||0.499
70906651|NCT02293837|141302773|SUPERIORITY|||||||0.267||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52||||0.267
70906652|NCT02293837|141302773|SUPERIORITY|||||||0.226||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 104||||0.226
70906653|NCT02293837|141302773|SUPERIORITY|||||||0.758||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 24||||0.758
70906654|NCT02293837|141302773|SUPERIORITY|||||||0.341||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52||||0.341
70906655|NCT02293837|141302773|SUPERIORITY|||||||0.969||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 104||||0.969
70906656|NCT02293837|141302773|SUPERIORITY|||||||0.689||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 24||||0.689
70906657|NCT02293837|141302773|SUPERIORITY|||||||0.4||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52||||0.400
70906658|NCT02293837|141302773|SUPERIORITY|||||||0.969||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 104||||0.969
70906659|NCT02293837|141302774|SUPERIORITY|||||||0.679||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was 2-hour C-peptide mAUC and covariates were treatment, study week, age, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept and study week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.679
70906660|NCT02293837|141302774|SUPERIORITY|||||||0.373||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was 2-hour C-peptide mAUC and covariates were treatment, study week, age, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept and study week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.373
70906661|NCT02293837|141302774|SUPERIORITY|||||||0.395||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was 2-hour C-peptide mAUC and covariates were treatment, study week, age, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept and study week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.395
70906662|NCT02293837|141302775|SUPERIORITY|||||||0.176||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52. Only participants \>=12 years old had the 4-hour MMTT performed.||||0.176
70906663|NCT02293837|141302775|SUPERIORITY|||||||0.285||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 104. Only participants \>=12 years old had the 4-hour MMTT performed.||||0.285
70906664|NCT02293837|141302775|SUPERIORITY|||||||0.435||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52||||0.435
70906665|NCT02293837|141302775|SUPERIORITY|||||||0.931||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 104||||0.931
70906666|NCT02293837|141302775|SUPERIORITY|||||||0.28||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52. Only participants \>=12 years old had the 4-hour MMTT performed.||||0.280
70906667|NCT02293837|141302775|SUPERIORITY|||||||0.985||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 104. Only participants \>=12 years old had the 4-hour MMTT performed.||||0.985
70906668|NCT02293837|141302776|SUPERIORITY|||||||0.762||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 24||||0.762
70906669|NCT02293837|141302776|SUPERIORITY|||||||0.64||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 52||||0.640
70906670|NCT02293837|141302776|SUPERIORITY|||||||0.145||||||P-value comes from an analysis of covariance with outcome variable of change in avg insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 104||||0.145
70906671|NCT02293837|141302776|SUPERIORITY|||||||0.033||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 24||||0.033
70906672|NCT02293837|141302776|SUPERIORITY|||||||0.591||||||P-value comes from an analysis of covariance with outcome variable of change in avg insulin use per kg from baseline and covariates of treatment, baseline avg insulin use per kg, and age.|ANCOVA|||Week 52||||0.591
70906673|NCT02293837|141302776|SUPERIORITY|||||||0.81||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 104||||0.810
70906674|NCT02293837|141302776|SUPERIORITY|||||||0.178||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 24||||0.178
70906675|NCT02293837|141302776|SUPERIORITY|||||||0.43||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 52||||0.430
70906676|NCT02293837|141302776|SUPERIORITY|||||||0.149||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 104||||0.149
70906677|NCT02293837|141302777|SUPERIORITY|||||||0.103||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was average insulin use per kg and covariates were treatment, study week, age, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept and study week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.103
70906678|NCT02293837|141302777|SUPERIORITY|||||||0.452||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was average insulin use per kg and covariates were treatment, study week, age, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept and study week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.452
70906679|NCT02293837|141302777|SUPERIORITY|||||||0.091||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was average insulin use per kg and covariates were treatment, study week, age, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept and study week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.091
70906680|NCT02293837|141302778|SUPERIORITY|||||||0.154||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 24||||0.154
70906681|NCT02293837|141302778|SUPERIORITY|||||||0.193||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 52||||0.193
70906682|NCT02293837|141302778|SUPERIORITY|||||||0.397||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 104||||0.397
70906683|NCT02293837|141302778|SUPERIORITY|||||||0.125||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 24||||0.125
70906684|NCT02293837|141302778|SUPERIORITY|||||||0.705||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 52||||0.705
70906685|NCT02293837|141302778|SUPERIORITY|||||||0.378||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 104||||0.378
70906686|NCT02293837|141302778|SUPERIORITY|||||||0.035||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 24||||0.035
70906687|NCT02293837|141302778|SUPERIORITY|||||||0.262||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 52||||0.262
70906688|NCT02293837|141302778|SUPERIORITY|||||||0.338||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 104||||0.338
70906689|NCT02293837|141302779|SUPERIORITY|||||||0.493||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was HbA1c and covariates were treatment, study week, spline week (at week 4), age, treatment\*spline week, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept, study week, and spline week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.493
70906690|NCT02293837|141302779|SUPERIORITY|||||||0.659||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was HbA1c and covariates were treatment, study week, spline week (at week 4), age, treatment\*spline week, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept, study week, and spline week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.659
70906691|NCT02293837|141302779|SUPERIORITY|||||||0.407||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was HbA1c and covariates were treatment, study week, spline week (at week 4), age, treatment\*spline week, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept, study week, and spline week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.407
70906692|NCT02293837|141302780|SUPERIORITY|||||||0.634||||||P-value is from comparing the number of participants with a hypoglycemic event between the two treatment groups using Fisher's exact test.|Fisher Exact|||Baseline to Week 52||||0.634
70906693|NCT02293837|141302780|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with a hypoglycemic event between the two treatment groups using Fisher's exact test.|Fisher Exact|||Baseline to Week 104/End of Study||||1.000
70906694|NCT02293837|141302780|SUPERIORITY|||||||0.329||||||P-value is from comparing the number of participants with a hypoglycemic event between the two treatment groups using Fisher's exact test.|Fisher Exact|||Baseline to Week 52||||0.329
70906695|NCT02293837|141302780|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with a hypoglycemic event between the two treatment groups using Fisher's exact test.|Fisher Exact|||Baseline to Week 104/End of Study||||1.000
70906696|NCT02293837|141302780|SUPERIORITY|||||||0.847||||||P-value is from comparing the number of participants with a hypoglycemic event between the two treatment groups using Fisher's exact test.|Fisher Exact|||Baseline to Week 52||||0.847
70906697|NCT02293837|141302780|SUPERIORITY|||||||0.858||||||P-value is from comparing the number of participants with a hypoglycemic event between the two treatment groups using Fisher's exact test.|Fisher Exact|||Baseline to Week 104/End of Study||||0.858
70906698|NCT02293837|141302781|SUPERIORITY|||||||0.296||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 52||||0.296
70906699|NCT02293837|141302781|SUPERIORITY|||||||0.145||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 52||||0.145
70906700|NCT02293837|141302781|SUPERIORITY|||||||0.027||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 52||||0.027
70906701|NCT02293837|141302782|SUPERIORITY|||||||0.547||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 52||||0.547
70906702|NCT02293837|141302782|SUPERIORITY|||||||0.551||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 52||||0.551
70906703|NCT04779242|141302783|OTHER|Difference was observed difference in early clinical success rate between the omadacycline and moxifloxacin groups|Percentage difference|1.9|||||TWO_SIDED|95.0|-3.0|6.8|||||95% CI is constructed based on the Miettinen and Nurminen method without stratification.|||6.8|-3.0|
70906704|NCT04779242|141302784|OTHER|Difference was observed difference in overall clinical success rate at PTE between the omadacycline and moxifloxacin groups.|Percentage difference|-1.7|||||TWO_SIDED|95.0|-6.9|3.4|||||95% CI is constructed based on the Miettinen and Nurminen method without stratification|||3.4|-6.9|
70906705|NCT04779242|141302785|OTHER|Difference was observed difference in overall clinical success rate at PTE between the omadacycline and moxifloxacin groups|Percentage difference|-1.8|||||TWO_SIDED|95.0|-5.7|2.0|||||95% CI is constructed based on the Miettinen and Nurminen method without stratification|||2.0|-5.7|
70906706|NCT01757067|141302786|OTHER|The previously stated primary and secondary endpoints cannot be calculated as the study was halted prematurely due to lack of enrollment. Only the reported EF data was collected. This makes further statistical analyses impossible.|||||||||||||||||The previously stated primary and secondary endpoints cannot be calculated as the study was halted prematurely due to lack of enrollment. Only the reported EF data was collected. This makes further statistical analyses impossible.|||
70906707|NCT01461993|141302803|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.82||||||95.0|0.72|0.94||||||HPV-6||0.94|0.72|
70906708|NCT01461993|141302803|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.82|||||TWO_SIDED|95.0|0.74|0.91||||||HPV-11||0.91|0.74|
70906709|NCT01461993|141302803|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.78|||||TWO_SIDED|95.0|0.68|0.88||||||HPV-16||0.88|0.68|
70906710|NCT01461993|141302803|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.71|||||TWO_SIDED|95.0|0.62|0.81||||||HPV-18||0.81|0.62|
70906711|NCT01461993|141302804|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.92|||||TWO_SIDED|95.0|0.85|1.0||||||PMB80 \[A22\]||1.00|0.85|
70906712|NCT01461993|141302804|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.92|||||TWO_SIDED|95.0|0.84|1.01||||||PMB2948 \[B24\]||1.01|0.84|
70906713|NCT03912220|141302830|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
70906714|NCT03912220|141302831|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
70906715|NCT03216902|141302838|SUPERIORITY|Claim superiority of DE-126 compare to Placebo at 3 timepoints (9:00, 13:00 and 17:00)|||||<|0.0001||||||P value is adjusted for multiple comparisons using Hochberg step-up procedure.|t-test, 2 sided|||This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.||||<0.0001
70906716|NCT03216902|141302838|SUPERIORITY|Claim superiority of DE-126 compare to Placebo at 3 timepoints (9:00, 13:00 and 17:00)|||||<|0.0001||||||P value is adjusted for multiple comparisons using Hochberg step-up procedure.|t-test, 2 sided|||This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.||||<0.0001
70906717|NCT03216902|141302838|SUPERIORITY|Claim superiority of DE-126 compare to Placebo at 3 timepoints (9:00, 13:00 and 17:00)|||||<|0.0001||||||P value is adjusted for multiple comparisons using Hochberg step-up procedure.|t-test, 2 sided|||This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.||||<0.0001
70906718|NCT03216902|141302838|SUPERIORITY|Claim superiority of DE-126 compare to Placebo at 3 timepoints (9:00, 13:00 and 17:00)|||||<|0.0001||||||P value is adjusted for multiple comparisons using Hochberg step-up procedure.|t-test, 2 sided|||This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.||||<0.0001
70906719|NCT01263106|141302847|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.12|||||TWO_SIDED|90.0|1.05|1.2|||Mixed Models Analysis|||||1.20|1.05|
70906720|NCT01263106|141302848|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|0.96|||||TWO_SIDED|90.0|0.92|1.01|||Mixed Models Analysis|||||1.01|0.92|
70906721|NCT01263106|141302849|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.8008|TWO_SIDED|90.0|-3.0|1.0|||Wilcoxon (Mann-Whitney)|||||1.00|-3.00|0.8008
70906722|NCT03662360|141302857|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The Mann-Whitney test has been used to evaluate the statistical significance of the difference between the variations in scores (T3 - T1) regarding the two interest groups of patients (control and treated).||||<0.001
70906723|NCT03662360|141302858|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||The Mann-Whitney test has been used to evaluate the statistical significance of the difference between the variations scores in T3 and T1, concerning the distress of the professional caregivers in the two intereste groups of patients||||<0.01
70906724|NCT00544544|141302902|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<.001
70906725|NCT00544544|141302903|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70906726|NCT00544544|141302904|SUPERIORITY_OR_OTHER|||||||0.38|||||||Mixed Models Analysis|||||||0.38
70906727|NCT00544544|141302905|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
70906728|NCT01644474|141302932|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.6|||<|0.0001|TWO_SIDED|95.0|-40.2|-23.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Alirocumab group was compared to ezetimibe group using an appropriate contrast statement.||-23.0|-40.2|<0.0001
70906729|NCT01644474|141302933|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.5|||<|0.0001|TWO_SIDED|95.0|-35.7|-21.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-21.2|-35.7|<0.0001
70906730|NCT01644474|141302934|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.8|||<|0.0001|TWO_SIDED|95.0|-32.3|-19.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.2|-32.3|<0.0001
70906731|NCT01644474|141302935|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.5|||<|0.0001|TWO_SIDED|95.0|-33.5|-17.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-17.4|-33.5|<0.0001
70906732|NCT01644474|141302936|SUPERIORITY_OR_OTHER||LS Mean Difference|-18.7|||<|0.0001|TWO_SIDED|95.0|-24.7|-12.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-12.7|-24.7|<0.0001
70906733|NCT01644474|141302937|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.7|||<|0.0001|TWO_SIDED|95.0|-31.5|-19.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.8|-31.5|<0.0001
70906734|NCT01644474|141302938|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.8|||<|0.0001|TWO_SIDED|95.0|-32.4|-19.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.2|-32.4|<0.0001
70906735|NCT01644474|141302939|SUPERIORITY_OR_OTHER||LS Mean Difference|-18.3|||<|0.0001|TWO_SIDED|95.0|-23.1|-13.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-13.5|-23.1|<0.0001
70906736|NCT01644474|141302940|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|34.8|||<|0.0001|TWO_SIDED|95.0|8.7|139.0||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||139.0|8.7|<0.0001
70906737|NCT01644474|141302941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|69.8||||0.0001|TWO_SIDED|95.0|8.8|556.0||Threshold for significance was ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||556.0|8.8|0.0001
70906738|NCT01644474|141302942|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.4||||0.4013|TWO_SIDED|95.0|-14.8|5.9||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.9|-14.8|0.4013
70906739|NCT02023879|141302950|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-56.4|||<|0.0001|TWO_SIDED|95.0|-62.9|-49.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Alirocumab 150 mg Q4W/up to 150 mg Q2W was compared to placebo group using an appropriate contrast statement.||-49.9|-62.9|<0.0001
70906740|NCT02023879|141302951|SUPERIORITY_OR_OTHER||LS Mean Difference|-59.7|||<|0.0001|TWO_SIDED|95.0|-65.6|-53.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-53.8|-65.6|<0.0001
70906741|NCT02023879|141302952|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.9|||<|0.0001|TWO_SIDED|95.0|-51.8|-38.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-38.1|-51.8|<0.0001
70906742|NCT02023879|141302953|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.4|||<|0.0001|TWO_SIDED|95.0|-54.8|-41.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-41.9|-54.8|<0.0001
70906743|NCT02023879|141302954|SUPERIORITY_OR_OTHER||LS Mean Difference|-55.5|||<|0.0001|TWO_SIDED|95.0|-61.1|-49.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-49.8|-61.1|<0.0001
70906744|NCT02023879|141302955|SUPERIORITY_OR_OTHER||LS Mean Difference|-58.6|||<|0.0001|TWO_SIDED|95.0|-63.8|-53.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-53.4|-63.8|<0.0001
70906745|NCT02023879|141302956|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.4|||<|0.0001|TWO_SIDED|95.0|-52.4|-40.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-40.4|-52.4|<0.0001
70906746|NCT02023879|141302957|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.6|||<|0.0001|TWO_SIDED|95.0|-54.3|-42.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-42.8|-54.3|<0.0001
70906747|NCT02023879|141302958|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.0|||<|0.0001|TWO_SIDED|95.0|-54.9|-43.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-43.2|-54.9|<0.0001
70906748|NCT02023879|141302959|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.7|||<|0.0001|TWO_SIDED|95.0|-57.1|-46.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-46.4|-57.1|<0.0001
70906749|NCT02023879|141302960|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.3|||<|0.0001|TWO_SIDED|95.0|-39.8|-30.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-30.8|-39.8|<0.0001
70906750|NCT02023879|141302961|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.2|||<|0.0001|TWO_SIDED|95.0|-44.3|-32.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-32.1|-44.3|<0.0001
70906751|NCT02023879|141302962|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.9|||<|0.0001|TWO_SIDED|95.0|-43.9|-31.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-31.8|-43.9|<0.0001
70906752|NCT02023879|141302963|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.3|||<|0.0001|TWO_SIDED|95.0|-30.9|-21.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-21.7|-30.9|<0.0001
70906753|NCT02023879|141302964|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|279.8|||<|0.0001|TWO_SIDED|95.0|29.1|2690.1||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||2690.1|29.1|<0.0001
70906754|NCT02023879|141302965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|354.7|||<|0.0001|TWO_SIDED|95.0|36.2|3479.5||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||3479.5|36.2|<0.0001
70906755|NCT02023879|141302966|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|126.0|||<|0.0001|TWO_SIDED|95.0|20.0|9999.0||Threshold for significance at 0.05 level.|Regression, Logistic|LOCF approach followed by logistic regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo (Confidence interval should be read as 20.0 to \>9999)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||9999|20.0|<0.0001
70906756|NCT02023879|141302967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|141.5|||<|0.0001|TWO_SIDED|95.0|22.2|9999.0||Threshold for significance at 0.05 level.|Regression, Logistic|LOCF approach followed by logistic regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo (Confidence interval should be read as 20.0 to \>9999)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||9999|22.2|<0.0001
70906757|NCT02023879|141302968|SUPERIORITY_OR_OTHER||Adjusted mean difference|-19.6||||0.0002|TWO_SIDED|95.0|-29.8|-9.4||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-9.4|-29.8|0.0002
70906758|NCT02023879|141302969|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.9||||0.0892|TWO_SIDED|95.0|-17.1|1.2||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||1.2|-17.1|0.0892
70906759|NCT02044458|141302978|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7|||||||t-test, 2 sided|||||||.70
70906760|NCT02044458|141302979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.38|||||||t-test, 2 sided|||||||.38
70906761|NCT02044458|141302980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.57|||||||Chi-squared|||||||.57
70967412|NCT01431274|141440929|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.077|STANDARD_ERROR_OF_MEAN|0.026||0.0027|TWO_SIDED|95.0|0.027|0.127||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.127|0.027|0.0027
70967413|NCT01431274|141440929|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.026||0.0003|TWO_SIDED|95.0|0.044|0.144||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.144|0.044|0.0003
70967414|NCT01431274|141440929|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.101|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.05|0.151||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.151|0.050|<0.0001
70967415|NCT01431274|141440929|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.007|STANDARD_ERROR_OF_MEAN|0.026||0.7925|TWO_SIDED|95.0|-0.057|0.044||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.044|-0.057|0.7925
70967416|NCT01431274|141440930|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.118|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.074|0.162||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).|||0.162|0.074|<0.0001
70967417|NCT01431274|141440930|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.123|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.077|0.169||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).|||0.169|0.077|<0.0001
70967418|NCT01431274|141440930|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.022||0.0012|TWO_SIDED|95.0|0.028|0.114||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).|||0.114|0.028|0.0012
70967419|NCT01431274|141440930|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.05|0.137||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).|||0.137|0.050|<0.0001
70967420|NCT01431274|141440930|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.023||0.001|TWO_SIDED|95.0|0.031|0.121||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).|||0.121|0.031|0.0010
70967421|NCT01431274|141440930|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.023||0.0384|TWO_SIDED|95.0|0.003|0.092||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).|||0.092|0.003|0.0384
70967422|NCT01431274|141440930|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.141|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.097|0.185||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).|||0.185|0.097|<0.0001
70967423|NCT01431274|141440930|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.004|STANDARD_ERROR_OF_MEAN|0.023||0.8428|TWO_SIDED|95.0|-0.049|0.04||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Olodaterol (5 µg).|||0.040|-0.049|0.8428
70967424|NCT01431274|141440930|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.022|STANDARD_ERROR_OF_MEAN|0.022||0.3048|TWO_SIDED|95.0|-0.065|0.02||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (2.5 µg) versus Olodaterol (5 µg).|||0.020|-0.065|0.3048
70967425|NCT01431274|141440930|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.018|STANDARD_ERROR_OF_MEAN|0.023||0.4311|TWO_SIDED|95.0|-0.027|0.063||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Tiotropium (2.5 µg).|||0.063|-0.027|0.4311
70967426|NCT01431274|141440931|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.098|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001|TWO_SIDED|95.0|0.057|0.139||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).|||0.139|0.057|<0.0001
70967427|NCT01431274|141440931|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.106|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.063|0.149||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).|||0.149|0.063|<0.0001
70967428|NCT01431274|141440931|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.051|STANDARD_ERROR_OF_MEAN|0.021||0.0136|TWO_SIDED|95.0|0.01|0.091||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).|||0.091|0.010|0.0136
70967429|NCT01431274|141440931|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.075|STANDARD_ERROR_OF_MEAN|0.021||0.0003|TWO_SIDED|95.0|0.035|0.116||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).|||0.116|0.035|0.0003
70967430|NCT01431274|141440931|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.059|STANDARD_ERROR_OF_MEAN|0.022||0.0065|TWO_SIDED|95.0|0.016|0.101||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).|||0.101|0.016|0.0065
70967431|NCT01431274|141440931|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.021||0.0277|TWO_SIDED|95.0|0.005|0.089||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).|||0.089|0.005|0.0277
70967432|NCT01431274|141440931|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.122|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001|TWO_SIDED|95.0|0.081|0.164||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).|||0.164|0.081|<0.0001
70967433|NCT01431274|141440931|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.008|STANDARD_ERROR_OF_MEAN|0.021||0.7116|TWO_SIDED|95.0|-0.049|0.034||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Olodaterol (5 µg).|||0.034|-0.049|0.7116
70967434|NCT01431274|141440931|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.024|STANDARD_ERROR_OF_MEAN|0.02||0.2332|TWO_SIDED|95.0|-0.065|0.016||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (2.5 µg) versus Olodaterol (5 µg).|||0.016|-0.065|0.2332
70967435|NCT01431274|141440931|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.017|STANDARD_ERROR_OF_MEAN|0.021||0.4374|TWO_SIDED|95.0|-0.025|0.059||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Tiotropium (2.5 µg).|||0.059|-0.025|0.4374
70967436|NCT01431274|141440932|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.161|STANDARD_ERROR_OF_MEAN|0.043||0.0002|TWO_SIDED|95.0|0.077|0.244||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).|||0.244|0.077|0.0002
70967437|NCT01431274|141440932|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.045||0.0017|TWO_SIDED|95.0|0.053|0.228||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).|||0.228|0.053|0.0017
70967438|NCT01431274|141440932|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.128|STANDARD_ERROR_OF_MEAN|0.042||0.0022|TWO_SIDED|95.0|0.046|0.21||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).|||0.210|0.046|0.0022
70967439|NCT01431274|141440932|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.176|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001|TWO_SIDED|95.0|0.093|0.259||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).|||0.259|0.093|<0.0001
70967440|NCT01431274|141440932|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.108|STANDARD_ERROR_OF_MEAN|0.044||0.0141|TWO_SIDED|95.0|0.022|0.194||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).|||0.194|0.022|0.0141
70967441|NCT01431274|141440932|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.032|STANDARD_ERROR_OF_MEAN|0.043||0.4581|TWO_SIDED|95.0|-0.053|0.118||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).|||0.118|-0.053|0.4581
70967442|NCT01431274|141440932|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.208|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|0.124|0.293||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).|||0.293|0.124|<0.0001
70967443|NCT01431274|141440932|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.043||0.6335|TWO_SIDED|95.0|-0.064|0.105||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Olodaterol (5 µg).|||0.105|-0.064|0.6335
70967444|NCT01431274|141440932|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.047|STANDARD_ERROR_OF_MEAN|0.041||0.253|TWO_SIDED|95.0|-0.129|0.034||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (2.5 µg) versus Olodaterol (5 µg).|||0.034|-0.129|0.2530
70967445|NCT01431274|141440932|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.068|STANDARD_ERROR_OF_MEAN|0.043||0.1188|TWO_SIDED|95.0|-0.017|0.153||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Tiotropium (2.5 µg).|||0.153|-0.017|0.1188
70967446|NCT01431274|141440933|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.137|STANDARD_ERROR_OF_MEAN|0.041||0.0008|TWO_SIDED|95.0|0.057|0.217||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).|||0.217|0.057|0.0008
70967447|NCT01431274|141440933|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.126|STANDARD_ERROR_OF_MEAN|0.043||0.0032|TWO_SIDED|95.0|0.042|0.209||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).|||0.209|0.042|0.0032
70967448|NCT01431274|141440933|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.105|STANDARD_ERROR_OF_MEAN|0.04||0.0085|TWO_SIDED|95.0|0.027|0.183||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).|||0.183|0.027|0.0085
70967449|NCT01431274|141440933|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.156|STANDARD_ERROR_OF_MEAN|0.04||0.0001|TWO_SIDED|95.0|0.077|0.235||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).|||0.235|0.077|0.0001
70967450|NCT01431274|141440933|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.042||0.0255|TWO_SIDED|95.0|0.011|0.176||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).|||0.176|0.011|0.0255
70967451|NCT01431274|141440933|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.032|STANDARD_ERROR_OF_MEAN|0.041||0.4393|TWO_SIDED|95.0|-0.049|0.113||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).|||0.113|-0.049|0.4393
70967452|NCT01431274|141440933|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.188|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.108|0.269||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).|||0.269|0.108|<0.0001
70967453|NCT01431274|141440933|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.041||0.7784|TWO_SIDED|95.0|-0.069|0.092||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Olodaterol (5 µg).|||0.092|-0.069|0.7784
70967454|NCT01431274|141440933|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.051|STANDARD_ERROR_OF_MEAN|0.039||0.1965|TWO_SIDED|95.0|-0.129|0.026||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (2.5 µg) versus Olodaterol (5 µg).|||0.026|-0.129|0.1965
70967455|NCT01431274|141440933|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.041||0.1315|TWO_SIDED|95.0|-0.019|0.144||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Tiotropium (2.5 µg).|||0.144|-0.019|0.1315
70967456|NCT01431274|141440934|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.141|STANDARD_ERROR_OF_MEAN|0.56||0.0001|TWO_SIDED|95.0|-3.239|-1.043||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||-1.043|-3.239|0.0001
70967457|NCT01431274|141440934|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.131|STANDARD_ERROR_OF_MEAN|0.56||0.0435|TWO_SIDED|95.0|-2.23|-0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).|||-0.033|-2.230|0.0435
70967458|NCT01431274|141440934|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.528|STANDARD_ERROR_OF_MEAN|0.559||0.0063|TWO_SIDED|95.0|-2.623|-0.432||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||-0.432|-2.623|0.0063
70967459|NCT01431274|141440934|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.517|STANDARD_ERROR_OF_MEAN|0.558||0.3545|TWO_SIDED|95.0|-1.611|0.577||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.577|-1.611|0.3545
70967460|NCT01431274|141440934|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.518|STANDARD_ERROR_OF_MEAN|0.559||0.3542|TWO_SIDED|95.0|-1.614|0.578||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.578|-1.614|0.3542
70967461|NCT01431274|141440934|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.613|STANDARD_ERROR_OF_MEAN|0.556||0.2697|TWO_SIDED|95.0|-1.702|0.476||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.476|-1.702|0.2697
70967462|NCT01431274|141440934|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.13|STANDARD_ERROR_OF_MEAN|0.559||0.0434|TWO_SIDED|95.0|-2.227|-0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||-0.033|-2.227|0.0434
70967463|NCT01431274|141440934|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.01|STANDARD_ERROR_OF_MEAN|0.563||0.0732|TWO_SIDED|95.0|-2.114|0.095||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.095|-2.114|0.0732
70967464|NCT01431274|141440934|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.011|STANDARD_ERROR_OF_MEAN|0.563||0.0724|TWO_SIDED|95.0|-2.114|0.092||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.092|-2.114|0.0724
70967465|NCT01431274|141440934|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.563||0.9983|TWO_SIDED|95.0|-1.102|1.104||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||1.104|-1.102|0.9983
70967466|NCT01431274|141440935|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.852|STANDARD_ERROR_OF_MEAN|0.578||0.0014|TWO_SIDED|95.0|-2.985|-0.718||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||-0.718|-2.985|0.0014
70967467|NCT01431274|141440935|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.444|STANDARD_ERROR_OF_MEAN|0.576||0.4413|TWO_SIDED|95.0|-1.573|0.686||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.686|-1.573|0.4413
70967468|NCT01431274|141440935|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.437|STANDARD_ERROR_OF_MEAN|0.578||0.0129|TWO_SIDED|95.0|-2.569|-0.304||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||-0.304|-2.569|0.0129
70967469|NCT01431274|141440935|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.056|STANDARD_ERROR_OF_MEAN|0.574||0.9222|TWO_SIDED|95.0|-1.182|1.07||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||1.070|-1.182|0.9222
70967470|NCT01431274|141440935|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.029|STANDARD_ERROR_OF_MEAN|0.576||0.9602|TWO_SIDED|95.0|-1.157|1.1||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|ANCOVA|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||1.100|-1.157|0.9602
70967471|NCT01431274|141440935|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.415|STANDARD_ERROR_OF_MEAN|0.57||0.4669|TWO_SIDED|95.0|-1.533|0.703||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.703|-1.533|0.4669
70967472|NCT01431274|141440935|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.471|STANDARD_ERROR_OF_MEAN|0.575||0.4126|TWO_SIDED|95.0|-1.598|0.656||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.656|-1.598|0.4126
70967473|NCT01431274|141440935|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.408|STANDARD_ERROR_OF_MEAN|0.583||0.0158|TWO_SIDED|95.0|-2.551|-0.265||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||-0.265|-2.551|0.0158
70967474|NCT01431274|141440935|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.381|STANDARD_ERROR_OF_MEAN|0.582||0.0177|TWO_SIDED|95.0|-2.521|-0.24||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||-0.240|-2.521|0.0177
70967475|NCT01431274|141440935|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.027|STANDARD_ERROR_OF_MEAN|0.58||0.9624|TWO_SIDED|95.0|-1.164|1.109||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||1.109|-1.164|0.9624
70967476|NCT01431274|141440936|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.595|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.329|0.862||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.862|0.329|<0.0001
70967477|NCT01431274|141440936|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.64|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.373|0.907||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.907|0.373|<0.0001
70967478|NCT01431274|141440936|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.423|STANDARD_ERROR_OF_MEAN|0.136||0.0019|TWO_SIDED|95.0|0.156|0.69||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.690|0.156|0.0019
70967479|NCT01431274|141440936|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.446|STANDARD_ERROR_OF_MEAN|0.136||0.0011|TWO_SIDED|95.0|0.179|0.712||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.712|0.179|0.0011
70967480|NCT01431274|141440936|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.468|STANDARD_ERROR_OF_MEAN|0.136||0.0006|TWO_SIDED|95.0|0.201|0.735||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.735|0.201|0.0006
70967481|NCT01431274|141440936|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.172|STANDARD_ERROR_OF_MEAN|0.136||0.2045|TWO_SIDED|95.0|-0.094|0.438||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.438|-0.094|0.2045
70967482|NCT01431274|141440936|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.618|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.351|0.885||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.885|0.351|<0.0001
70967483|NCT01431274|141440936|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.045|STANDARD_ERROR_OF_MEAN|0.137||0.7432|TWO_SIDED|95.0|-0.313|0.223||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.223|-0.313|0.7432
70967484|NCT01431274|141440936|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.023|STANDARD_ERROR_OF_MEAN|0.136||0.8687|TWO_SIDED|95.0|-0.29|0.245||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.245|-0.290|0.8687
70967485|NCT01431274|141440936|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.022|STANDARD_ERROR_OF_MEAN|0.137||0.8709|TWO_SIDED|95.0|-0.29|0.246||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.246|-0.290|0.8709
70967486|NCT01431274|141440937|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.63|STANDARD_ERROR_OF_MEAN|0.137|<|0.0001|TWO_SIDED|95.0|0.362|0.898||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.898|0.362|<0.0001
70967487|NCT01431274|141440937|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.434|STANDARD_ERROR_OF_MEAN|0.137||0.0015|TWO_SIDED|95.0|0.166|0.703||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.703|0.166|0.0015
70967488|NCT01431274|141440937|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.419|STANDARD_ERROR_OF_MEAN|0.137||0.0022|TWO_SIDED|95.0|0.151|0.687||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.687|0.151|0.0022
70967489|NCT01431274|141440937|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.227|STANDARD_ERROR_OF_MEAN|0.137||0.0966|TWO_SIDED|95.0|-0.041|0.495||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.495|-0.041|0.0966
70967490|NCT01431274|141440937|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.223|STANDARD_ERROR_OF_MEAN|0.137||0.1029|TWO_SIDED|95.0|-0.045|0.492||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.492|-0.045|0.1029
70967491|NCT01431274|141440937|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.211|STANDARD_ERROR_OF_MEAN|0.136||0.122|TWO_SIDED|95.0|-0.056|0.478||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.478|-0.056|0.1220
70967492|NCT01431274|141440937|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.438|STANDARD_ERROR_OF_MEAN|0.137||0.0014|TWO_SIDED|95.0|0.17|0.707||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.707|0.170|0.0014
70967493|NCT01431274|141440937|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.196|STANDARD_ERROR_OF_MEAN|0.137||0.1542|TWO_SIDED|95.0|-0.074|0.465||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.465|-0.074|0.1542
70967494|NCT01431274|141440937|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.192|STANDARD_ERROR_OF_MEAN|0.137||0.1626|TWO_SIDED|95.0|-0.077|0.461||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.461|-0.077|0.1626
70967495|NCT01431274|141440937|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.004|STANDARD_ERROR_OF_MEAN|0.138||0.9765|TWO_SIDED|95.0|-0.265|0.274||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.274|-0.265|0.9765
70967496|NCT01431274|141440938|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.647|STANDARD_ERROR_OF_MEAN|0.142|<|0.0001|TWO_SIDED|95.0|0.37|0.925||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.925|0.370|<0.0001
70967497|NCT01431274|141440938|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.322|STANDARD_ERROR_OF_MEAN|0.141||0.0226|TWO_SIDED|95.0|0.045|0.6||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.600|0.045|0.0226
70967498|NCT01431274|141440938|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.371|STANDARD_ERROR_OF_MEAN|0.142||0.0089|TWO_SIDED|95.0|0.093|0.649||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.649|0.093|0.0089
70967499|NCT01431274|141440938|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.332|STANDARD_ERROR_OF_MEAN|0.141||0.0186|TWO_SIDED|95.0|0.056|0.609||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.609|0.056|0.0186
70967500|NCT01431274|141440938|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.046|STANDARD_ERROR_OF_MEAN|0.142||0.7441|TWO_SIDED|95.0|-0.231|0.324||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.324|-0.231|0.7441
70967501|NCT01431274|141440938|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.276|STANDARD_ERROR_OF_MEAN|0.14||0.0492|TWO_SIDED|95.0|0.001|0.551||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 μg).~Spatial power covariance structure for within-patient errors."|||0.551|0.001|0.0492
70967502|NCT01431274|141440938|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.608|STANDARD_ERROR_OF_MEAN|0.141|<|0.0001|TWO_SIDED|95.0|0.332|0.884||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.884|0.332|<0.0001
70967503|NCT01431274|141440938|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.325|STANDARD_ERROR_OF_MEAN|0.143||0.023|TWO_SIDED|95.0|0.045|0.605||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg)~Spatial power covariance structure for within-patient errors."|||0.605|0.045|0.0230
70967504|NCT01431274|141440938|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.039|STANDARD_ERROR_OF_MEAN|0.142||0.7855|TWO_SIDED|95.0|-0.24|0.317||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.317|-0.240|0.7855
70967505|NCT01431274|141440938|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.286|STANDARD_ERROR_OF_MEAN|0.142||0.0442|TWO_SIDED|95.0|0.007|0.564||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.564|0.007|0.0442
70967506|NCT00941668|141440939|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70967507|NCT00941668|141440940|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
70967508|NCT00916149|141440957|OTHER||||||>|0.05||||||For each group (levetiracetam and no treatment), the change in IEDs/hour from pre to post-intervention: p \>0.05. The a priori threshold for statistical significance was p=0.05.|Wilcoxon Signed Ranks Test|||Change in frequency of IEDs/per hour was assessed for each group (levetiracetam and no treatment)||||>0.05
70967509|NCT00916149|141440958|OTHER|||||||0.005|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Trial 1 Learning Score from pre to post time points in the no treatment group.||||0.005
70967510|NCT00916149|141440958|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Trial 1 Learning Score from pre to post time points in the levetiracetam group.||||>0.05
70967511|NCT00916149|141440959|OTHER|||||||0.016|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Total Learning Score from pre to post time points in the no treatment group.||||0.016
70967512|NCT00916149|141440959|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Total Learning Score from pre to post time points in the levetiracetam treatment group.||||>0.05
70967513|NCT00916149|141440960|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Short Delay score from pre to post time points in the no treatment group.||||>0.05
70967514|NCT00916149|141440960|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Short Delay score from pre to post time points in the levetiracetam treatment group.||||>0.05
70967515|NCT00916149|141440961|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Long Delay score from pre to post time points in the no treatment group.||||>0.05
70967516|NCT00916149|141440961|OTHER|||||||0.045|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Long Delay score from pre to post time points in the levetiracetam treatment group.||||0.045
70967517|NCT00916149|141440962|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Learning score from pre to post time points in the no treatment group.||||>0.05
70967518|NCT00916149|141440962|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Learning score from pre to post time points in the levetiracetam treatment group.||||>0.05
70967519|NCT00916149|141440963|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Total Learning score from pre to post time points in the no treatment group||||>0.05
70967520|NCT00916149|141440963|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Total Learning score from pre to post time points in the levetiracetam treatment group||||>0.05
70967521|NCT00916149|141440964|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Delayed Recall score from pre to post time points in the no treatment group||||>0.05
70967522|NCT00916149|141440964|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Delayed Recall score from pre to post time points in the levetiracetam treatment group||||>0.05
70967523|NCT00916149|141440965|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the QOLIE score from pre to post time points in the levetiracetam treatment group||||>0.05
70967524|NCT00916149|141440966|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Letter Number Sequencing score from pre to post time points in the no treatment group||||>0.05
70967525|NCT00916149|141440966|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Letter Number Sequencing score from pre to post time points in the levetiracetam treatment group||||>0.05
70967526|NCT00916149|141440967|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Spatial Span score from pre to post time points in the no treatment group||||>0.05
70967527|NCT00916149|141440967|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Spatial Span score from pre to post time points in the levetiracetam treatment group||||>0.05
70967528|NCT00916149|141440968|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Digit Span score from pre to post time points in the no treatment group||||>0.05
70967529|NCT00916149|141440968|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Digit Span score from pre to post time points in the levetiracetam treatment group||||>0.05
70967530|NCT00916149|141440969|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Fluency score from pre to post time points in the no treatment group||||>0.05
70967531|NCT00916149|141440969|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Fluency score from pre to post time points in the levetiracetam treatment group||||>0.05
70967532|NCT00916149|141440970|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in Stroop performance from pre to post time points in the no treatment group||||>0.05
70967533|NCT00916149|141440970|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in Stroop performance from pre to post time points in the levetiracetam treatment group||||>0.05
70967534|NCT00916149|141440971|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Design Fluency score from pre to post time points in the no treatment group||||>0.05
70967535|NCT00916149|141440971|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Design Fluency score from pre to post time points in the levetiracetam treatment group||||>0.05
70967536|NCT00916149|141440972|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in performance on the Trails Test from pre to post time points in the no treatment group||||>0.05
70967537|NCT00916149|141440972|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in performance on the Trails Test from pre to post time points in the levetiracetam treatment group||||>0.05
70967538|NCT00916149|141440973|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in performance on the Grooved Pegboard task from pre to post time points in the no treatment group||||>0.05
70967539|NCT00916149|141440973|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in performance on the Grooved Pegboard task from pre to post time points in the levetiracetam treatment group||||>0.05
70967540|NCT00916149|141440974|OTHER|||||||0.014|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Digit Symbol score from pre to post time points in the no treatment group||||0.014
70967541|NCT00916149|141440974|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Digit Symbol score from pre to post time points in the levetiracetam treatment group||||>0.05
70967542|NCT00916149|141440975|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CPT Accuracy score from pre to post time points in the no treatment group||||>0.05
70967543|NCT00916149|141440975|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CPT Accuracy score from pre to post time points in the levetiracetam treatment group||||>0.05
70967544|NCT00916149|141440976|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CPT reaction time from pre to post time points in the no treatment group||||>0.05
70967545|NCT00916149|141440976|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CPT reaction time from pre to post time points in the levetiracetam treatment group||||>0.05
70967546|NCT00916149|141440977|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Choice Accuracy score from pre to post time points in the no treatment group||||>0.05
70967547|NCT00916149|141440978|OTHER|||||||0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Choice Reaction Time score from pre to post time points in the no treatment group||||0.05
70967548|NCT00916149|141440979|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Working Memory Accuracy score from pre to post time points in the no treatment group||||>0.05
70967549|NCT00916149|141440979|OTHER|||||||0.039|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Working Memory Accuracy score from pre to post time points in the levetiracetam treatment group||||0.039
70967550|NCT00916149|141440980|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Working Memory Reaction Time from pre to post time points in the no treatment group||||>0.05
70967551|NCT00916149|141440980|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Working Memory Reaction Time from pre to post time points in the levetiracetam treatment group||||>0.05
70967552|NCT00916149|141440981|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Non-verbal Working Memory Accuracy score from pre to post time points in the no treatment group||||>0.05
70967553|NCT00916149|141440981|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Non-verbal Working Memory Accuracy score from pre to post time points in the levetiracetam treatment group||||>0.05
70967554|NCT00916149|141440982|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Non-verbal Working Memory Reaction Time from pre to post time points in the no treatment group||||>0.05
70967555|NCT00916149|141440982|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Non-verbal Working Memory Reaction Time from pre to post time points in the levetiracetam treatment group||||>0.05
70967556|NCT00916149|141440983|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Recognition Accuracy score from pre to post time points in the no treatment group||||>0.05
70967557|NCT00916149|141440983|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Recognition Accuracy score from pre to post time points in the levetiracetam treatment group||||>0.05
70967558|NCT00916149|141440984|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Recognition Reaction Time from pre to post time points in the no treatment group||||>0.05
70967559|NCT00916149|141440984|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Recognition Reaction Time from pre to post time points in the levetiracetam treatment group||||>0.05
70967560|NCT00916149|141440985|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Facial Recognition Accuracy score from pre to post time points in the no treatment group||||>0.05
70967561|NCT00916149|141440985|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Facial Recognition Accuracy score from pre to post time points in the levetiracetam treatment group||||>0.05
70967562|NCT00916149|141440986|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Facial Recognition Reaction Time from pre to post time points in the no treatment group||||>0.05
70967563|NCT00916149|141440986|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Facial Recognition Reaction Time from pre to post time points in the levetiracetam treatment group||||>0.05
70967564|NCT00916149|141440987|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the NDDIE score from pre to post time points in the no treatment group||||>0.05
70967565|NCT00916149|141440987|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the NDDIE score from pre to post time points in the levetiracetam treatment group||||>0.05
70967566|NCT00916149|141440988|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the AEP score from pre to post time points in the no treatment group||||>0.05
70967567|NCT00916149|141440988|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the AEP score from pre to post time points in the levetiracetam treatment group||||>0.05
70967568|NCT00307151|141441008|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.6||||0.015|TWO_SIDED|95.0|3.7|33.6||P-value not adjusted for multiple interim analyses, but adjustment would be negligible because Peto-Haybittle spending function used as basis for calculating repeated confidence intervals used in interim monitoring.|t-test, 2 sided|Risk difference estimate stratified by age (\<12 months vs. \>=12 months)and reports rate on NVP arm minus rate on LPV/r arm|Endpoint rates with standard errors calculated from Kaplan-Meier curves for each treatment group and age stratum. Differences in week 24 failure proportions by treatment calculated weighted by the inverse of the variance in each age stratum.|||33.6|3.7|0.015
70967569|NCT00307151|141441008|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.5|||<|0.001|TWO_SIDED|95.0|11.2|31.8||P-value not adjusted for multiple interim analyses, but adjustment would be negligible because Peto-Haybittle spending function used as basis for calculating repeated confidence intervals used in interim monitoring.|t-test, 2 sided|Risk difference estimate stratified by age (\<12 months vs. \>=12 months) and reports rate on NVP arm minus rate on LPV/r arm|Endpoint rates with standard errors calculated from Kaplan-Meier curves for each treatment group and age stratum. Differences in week 24 failure proportions by treatment calculated weighted by the inverse of the variance in each age stratum.|||31.8|11.2|<0.001
70967570|NCT00253643|141441032|SUPERIORITY_OR_OTHER|||||||0.1521|TWO_SIDED|||||Utilized a priori threshold for statistical significance of 0.05.|Mixed Models Analysis|||Mixed effects model to assess the effect time (pre vs. post) and treatment (GTFO, GT, FO and Placebo) on FAS summary scores||||0.1521
70967571|NCT00253643|141441033|SUPERIORITY_OR_OTHER|||||||0.1573|TWO_SIDED|||||A priori threshold for statistical significance is 0.05.|Mixed Models Analysis|||Mixed effects model to assess the effect of time (pre vs. post) and treatment (GTFO, GT, FO and Placebo) on Ki-67||||0.1573
70967572|NCT01111851|141441034|SUPERIORITY_OR_OTHER||Geometric Mean Ratio of the LS Means|1.0|||||TWO_SIDED|90.0|0.99|1.01|||||"The point estimate and 90% confidence interval (CI) were generated for the geometric mean ratio (GMR) \[aprepitant~165 mg/fosaprepitant 150 mg\]."|||1.01|0.99|
70967573|NCT01111851|141441035|SUPERIORITY_OR_OTHER||Geometric Mean Ratio of the LS means|1.0|||||TWO_SIDED|90.0|0.98|1.02|||||"The point estimate and 90% confidence interval (CI) were generated for the geometric mean ratio (GMR) \[aprepitant~165 mg/fosaprepitant 150 mg\]."|||1.02|0.98|
70967574|NCT01111851|141441036|SUPERIORITY_OR_OTHER||Geometric Mean Ratio of the LS means|1.0|||||TWO_SIDED|90.0|0.97|1.03|||||"The point estimate and 90% confidence interval (CI) were generated for the geometric mean ratio (GMR) \[aprepitant~165 mg/fosaprepitant 150 mg\]."|||1.03|0.97|
70967575|NCT01111851|141441037|SUPERIORITY_OR_OTHER||Geometric Mean Ratio of the LS means|0.91|||||TWO_SIDED|90.0|0.5|1.66|||||"The point estimate and 90% confidence interval (CI) were generated for the geometric mean ratio (GMR) \[aprepitant~165 mg/fosaprepitant 150 mg\]."|||1.66|0.50|
70967576|NCT01471015|141441039|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.006
70967577|NCT01471015|141441040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.003
70967578|NCT01299376|141441046|SUPERIORITY_OR_OTHER||Difference in Least-squares Means|-5.9|||<|0.001|TWO_SIDED|95.0|-7.5|-4.2|||Contrained Longitudinal Data Analysis|Model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups.||||-4.2|-7.5|<0.001
70967579|NCT01299376|141441057|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-10.3|||<|0.001|TWO_SIDED|95.0|-12.8|-7.7||Model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups.|Constrained Longitudinal Data Analysis|||||-7.7|-12.8|<0.001
70967580|NCT04315181|141441060|SUPERIORITY||||||<|0.0001||||||Statistical significance is 2-sided and accepted at a P value of ≤ 0.05.|Mixed Models Analysis|F=6.89, df=8, 72||Peak scores were calculated for individual participants within each dose condition and analyzed in a one-factor model (drug condition) with a compound symmetry covariance structure.||||<0.0001
70967581|NCT04315181|141441061|SUPERIORITY||||||<|0.0001||||||Statistical significance is 2-sided and accepted at a P value of ≤ 0.05.|Mixed Models Analysis|F=5.51, df=8, 72||Peak scores were calculated for individual participants within each dose condition and analyzed in a one-factor model (drug condition) with a compound symmetry covariance structure.||||<0.0001
70967582|NCT04315181|141441062|SUPERIORITY|||||||0.138||||||Statistical significance is 2-sided and accepted at a P value of ≤ 0.05.|Mixed Models Analysis|F=1.61, df=8, 72||Trough scores were calculated for individual participants within each dose condition and analyzed in a one-factor model (drug condition) with a compound symmetry covariance structure.||||0.138
70967583|NCT04315181|141441063|SUPERIORITY||||||<|0.0001||||||Statistical significance is 2-sided and accepted at a P value of ≤ 0.05.|Mixed Models Analysis|F=8.15, df=8, 72||Peak scores were calculated for individual participants within each dose condition and analyzed in a one-factor model (drug condition) with a compound symmetry covariance structure.||||<0.0001
70967584|NCT04315181|141441064|SUPERIORITY|||||||0.0002||||||Statistical significance is 2-sided and accepted at a P value of ≤ 0.05.|Mixed Models Analysis|F=4.58, df=8, 72||Trough scores were calculated for individual participants within each dose condition and analyzed in a one-factor model (drug condition) with a compound symmetry covariance structure.||||0.0002
70967585|NCT05879107|141441065|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.48|||||TWO_SIDED|95.0|1.22|1.81|||||The analysis of covariance (ANCOVA) model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 1||1.81|1.22|
70967586|NCT05879107|141441065|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.31|||||TWO_SIDED|95.0|1.12|1.54|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 3||1.54|1.12|
70967587|NCT05879107|141441065|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.34|||||TWO_SIDED|95.0|1.13|1.58|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 4||1.58|1.13|
70967588|NCT05879107|141441065|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.36|||||TWO_SIDED|95.0|1.08|1.71|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 5||1.71|1.08|
70967589|NCT05879107|141441065|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.37|||||TWO_SIDED|95.0|1.12|1.69|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 6A||1.69|1.12|
70967590|NCT05879107|141441065|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.41|||||TWO_SIDED|95.0|1.17|1.7|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 6B||1.70|1.17|
70967591|NCT05879107|141441065|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.34|||||TWO_SIDED|95.0|1.16|1.55|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 7F||1.55|1.16|
70967592|NCT05879107|141441065|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.38|||||TWO_SIDED|95.0|1.17|1.64|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 8||1.64|1.17|
70967593|NCT05879107|141441065|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.24|||||TWO_SIDED|95.0|1.05|1.47|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 9V||1.47|1.05|
70967594|NCT05879107|141441065|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.22|||||TWO_SIDED|95.0|1.03|1.44|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 10A||1.44|1.03|
70967595|NCT05879107|141441065|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.18|||||TWO_SIDED|95.0|0.98|1.42|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 11A||1.42|0.98|
70967596|NCT05879107|141441065|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.2|||||TWO_SIDED|95.0|0.99|1.46|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 12F||1.46|0.99|
70967597|NCT05879107|141441065|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.42|||||TWO_SIDED|95.0|1.21|1.67|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 14||1.67|1.21|
70967598|NCT05879107|141441065|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.46|||||TWO_SIDED|95.0|1.22|1.76|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 15B||1.76|1.22|
70967599|NCT05879107|141441065|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.29|||||TWO_SIDED|95.0|1.07|1.55|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 18C||1.55|1.07|
70967600|NCT05879107|141441065|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.39|||||TWO_SIDED|95.0|1.2|1.61|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 19A||1.61|1.20|
70967601|NCT05879107|141441065|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.33|||||TWO_SIDED|95.0|1.12|1.57|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 19F||1.57|1.12|
70967602|NCT05879107|141441065|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.34|||||TWO_SIDED|95.0|1.12|1.6|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 22F||1.60|1.12|
70967603|NCT05879107|141441065|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.36|||||TWO_SIDED|95.0|1.09|1.71|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 23F||1.71|1.09|
70967604|NCT05879107|141441065|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.4|||||TWO_SIDED|95.0|1.2|1.64|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 33F||1.64|1.20|
70967605|NCT05879107|141441066|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio between the Control group (at Day 61) versus Co-administration group (at Day 31) for RSV-A neutralizing titer was \<=1.5.|GMT ratio|1.06|||||TWO_SIDED|95.0|0.94|1.2|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|RSV-A||1.20|0.94|
70967606|NCT05879107|141441067|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio between the Control group (at Day 61) versus Co-administration group (at Day 31) for RSV-B neutralizing titer was \<=1.5.|GMT ratio|1.0|||||TWO_SIDED|95.0|0.89|1.13|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|RSV-B||1.13|0.89|
70967607|NCT01748942|141441081|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||0.25
70967608|NCT01748942|141441084|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
70967609|NCT01748942|141441085|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
70967610|NCT01748942|141441086|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
70967611|NCT01748942|141441087|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
70967612|NCT01748942|141441088|SUPERIORITY|||||||0.15|||||||Log Rank|||||||0.15
70967613|NCT02012621|141441241|OTHER||Odds Ratio (OR)|73.5|||<|0.0001|TWO_SIDED|95.0|25.7|210.5|||Regression, Logistic|||||210.5|25.7|<0.0001
70967614|NCT02012621|141441242|OTHER||Odds Ratio (OR)|8.5||||0.0012|TWO_SIDED|95.0|2.3|30.9|||Regression, Logistic|||||30.9|2.3|0.0012
70967615|NCT02012621|141441243|OTHER||Odds Ratio (OR)|4.7|||<|0.0001|TWO_SIDED|95.0|2.6|8.7|||Regression, Logistic|||||8.7|2.6|<0.0001
70967616|NCT03184077|141441247|SUPERIORITY|||||||0.16|||||||Chi-squared|||||||0.16
70967617|NCT03184077|141441248|SUPERIORITY|||||||0.62|||||||Chi-squared|||||||0.62
70967618|NCT03184077|141441249|SUPERIORITY|||||||0.01||||||This is a calculated p value|Chi-squared|||||||0.01
70967619|NCT02046096|141441258|OTHER||12-month rate (%)|97.8|||<|0.0001|TWO_SIDED|95.0|95.6|99.1||The threshold for statistical significance was p = 0.025|One-tailed Exact binomial test||The 95% confidence interval was computed using Exact method.|Null Hypothesis: The rate of technical placement success and 12-month freedom from new symptomatic PE while a filter is indwelling, π, does not meet the performance goal (90%).||99.1|95.6|<0.0001
70967620|NCT02046096|141441259|OTHER||Cumulative probability|81.5|STANDARD_ERROR_OF_MEAN|4.5||0.369|TWO_SIDED|95.0|72.6|90.4||the threshold for statistical significance is 0.025.|Z-statistic|The hypothesis is assessed using a Z-statistic. The Z-statistic is given by Z = (Ŝ(t) - 0.8) / SE where SE is the Standard Error|The estimate of the variance of the Kaplan-Meier estimate used the methods described by Peto et al.|"the null hypotheses is: H0: S(t) ≤ 80%(Performance Goal) where,~* t is time through 12 months~* S(t) is the true rate of freedom from major adverse events at time t."||90.4|72.6|0.369
70967621|NCT02046096|141441260|OTHER||12-month freedom from MAE rate (%)|86.7||||0.001|TWO_SIDED|95.0|82.5|90.2||The threshold for statistical significance was p = 0.025|One-tailed exact binomial test|||Null Hypothesis: The 12-month freedom from MAE, π, does not meet the performance goal (80%).||90.2|82.5|0.001
70967622|NCT02090413|141441266|SUPERIORITY_OR_OTHER||Difference in percentage|2.4|||||TWO_SIDED|95.0|-6.4|11.2|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 1-4 combined||11.2|-6.4|
70967623|NCT02090413|141441266|SUPERIORITY_OR_OTHER||Difference in percentage|-1.3|||||TWO_SIDED|95.0|-10.8|8.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 1-4 combined||8.3|-10.8|
70967624|NCT02090413|141441266|SUPERIORITY_OR_OTHER||Difference in percentage|2.0|||||TWO_SIDED|95.0|-9.3|13.2|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 1||13.2|-9.3|
70967625|NCT02090413|141441266|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-11.4|11.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 1||11.4|-11.4|
70967626|NCT02090413|141441266|SUPERIORITY_OR_OTHER||Difference in percentage|-14.8|||||TWO_SIDED|95.0|-29.2|-0.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 2||-0.3|-29.2|
70967627|NCT02090413|141441266|SUPERIORITY_OR_OTHER||Difference in percentage|-7.0|||||TWO_SIDED|95.0|-20.9|6.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 2||6.9|-20.9|
70967628|NCT02090413|141441266|SUPERIORITY_OR_OTHER||Difference in percentage|-17.6|||||TWO_SIDED|95.0|-32.8|-2.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 3||-2.4|-32.8|
70967629|NCT02090413|141441266|SUPERIORITY_OR_OTHER||Difference in percentage|-19.0|||||TWO_SIDED|95.0|-34.1|-3.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 3||-3.9|-34.1|
70967630|NCT02090413|141441266|SUPERIORITY_OR_OTHER||Difference in percentage|-4.8|||||TWO_SIDED|95.0|-21.0|11.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 4||11.4|-21.0|
70967631|NCT02090413|141441266|SUPERIORITY_OR_OTHER||Difference in percentage|-4.8|||||TWO_SIDED|95.0|-21.0|11.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 4||11.4|-21.0|
70967632|NCT02090413|141441267|SUPERIORITY_OR_OTHER||Difference in percentage|4.9|||||TWO_SIDED|95.0|-2.6|12.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing events||12.4|-2.6|
70967633|NCT02090413|141441267|SUPERIORITY_OR_OTHER||Difference in percentage|5.0|||||TWO_SIDED|95.0|-2.5|12.5|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing events||12.5|-2.5|
70967634|NCT02090413|141441267|SUPERIORITY_OR_OTHER||Difference in percentage|-1.5|||||TWO_SIDED|95.0|-11.2|8.1|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall redness events||8.1|-11.2|
70967635|NCT02090413|141441267|SUPERIORITY_OR_OTHER||Difference in percentage|-1.3|||||TWO_SIDED|95.0|-10.8|8.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall redness events||8.3|-10.8|
70967636|NCT02090413|141441267|SUPERIORITY_OR_OTHER||Difference in percentage|4.9|||||TWO_SIDED|95.0|-1.8|11.7|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall warmth events||11.7|-1.8|
70967637|NCT02090413|141441267|SUPERIORITY_OR_OTHER||Difference in percentage|5.0|||||TWO_SIDED|95.0|-1.7|11.7|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall warmth events||11.7|-1.7|
70967638|NCT02090413|141441267|SUPERIORITY_OR_OTHER||Difference in percentage|5.9|||||TWO_SIDED|95.0|-5.4|17.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall tingling events||17.3|-5.4|
70967639|NCT02090413|141441267|SUPERIORITY_OR_OTHER||Difference in percentage|5.0|||||TWO_SIDED|95.0|-6.4|16.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall tingling events||16.4|-6.4|
70967640|NCT02090413|141441267|SUPERIORITY_OR_OTHER||Difference in percentage|-8.0|||||TWO_SIDED|95.0|-19.5|3.5|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall itching events||3.5|-19.5|
70967641|NCT02090413|141441267|SUPERIORITY_OR_OTHER||Difference in percentage|-11.3|||||TWO_SIDED|95.0|-23.1|0.6|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall itching events||0.6|-23.1|
70967642|NCT02090413|141441270|SUPERIORITY_OR_OTHER||Difference in percentage|-1.4|||||TWO_SIDED|95.0|-15.8|13.0|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 5-8 combined||13.0|-15.8|
70967643|NCT02090413|141441270|SUPERIORITY_OR_OTHER||Difference in percentage|5.4|||||TWO_SIDED|95.0|-8.4|19.1|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 5-8 combined||19.1|-8.4|
70967644|NCT02090413|141441270|SUPERIORITY_OR_OTHER||Difference in percentage|6.5|||||TWO_SIDED|95.0|-9.9|23.0|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 9-12 combined||23.0|-9.9|
70967645|NCT02090413|141441270|SUPERIORITY_OR_OTHER||Difference in percentage|15.7|||||TWO_SIDED|95.0|0.2|31.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 9-12 combined||31.3|0.2|
70967646|NCT02090413|141441271|SUPERIORITY_OR_OTHER||Difference in percentage|2.6|||||TWO_SIDED|95.0|-10.2|15.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing, Weeks 5-8 combined||15.4|-10.2|
70967647|NCT02090413|141441271|SUPERIORITY_OR_OTHER||Difference in percentage|4.0|||||TWO_SIDED|95.0|-8.6|16.6|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing, Weeks 5-8 combined||16.6|-8.6|
70967648|NCT02090413|141441271|SUPERIORITY_OR_OTHER||Difference in percentage|3.1|||||TWO_SIDED|95.0|-12.8|18.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing, Weeks 9-12 combined||18.9|-12.8|
70967649|NCT02090413|141441271|SUPERIORITY_OR_OTHER||Difference in percentage|12.3|||||TWO_SIDED|95.0|-2.8|27.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing, Weeks 9-12 combined||27.3|-2.8|
70967650|NCT02090413|141441271|SUPERIORITY_OR_OTHER||Difference in percentage|-1.8|||||TWO_SIDED|95.0|-15.7|12.2|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Redness, Weeks 5-8 combined||12.2|-15.7|
70967651|NCT02090413|141441271|SUPERIORITY_OR_OTHER||Difference in percentage|4.0|||||TWO_SIDED|95.0|-9.4|17.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Redness, Weeks 5-8 combined||17.3|-9.4|
70967652|NCT02090413|141441271|SUPERIORITY_OR_OTHER||Difference in percentage|-9.0|||||TWO_SIDED|95.0|-25.1|7.0|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Redness, Weeks 9-12 combined||7.0|-25.1|
70967653|NCT02090413|141441271|SUPERIORITY_OR_OTHER||Difference in percentage|3.3|||||TWO_SIDED|95.0|-12.0|18.5|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Redness, Weeks 9-12 combined||18.5|-12.0|
70967654|NCT02090413|141441271|SUPERIORITY_OR_OTHER||Difference in percentage|-0.3|||||TWO_SIDED|95.0|-13.5|12.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Warmth, Weeks 5-8 combined||12.9|-13.5|
70967655|NCT02090413|141441271|SUPERIORITY_OR_OTHER||Difference in percentage|2.6|||||TWO_SIDED|95.0|-10.2|15.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Warmth, Weeks 5-8 combined||15.4|-10.2|
70967656|NCT02090413|141441271|SUPERIORITY_OR_OTHER||Difference in percentage|0.2|||||TWO_SIDED|95.0|-15.3|15.7|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Warmth, Weeks 9-12 combined||15.7|-15.3|
70967657|NCT02090413|141441271|SUPERIORITY_OR_OTHER||Difference in percentage|4.8|||||TWO_SIDED|95.0|-10.3|19.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Warmth, Weeks 9-12 combined||19.9|-10.3|
70967658|NCT02090413|141441271|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0|||||TWO_SIDED|95.0|-18.4|14.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Tingling, Weeks 5-8 combined||14.3|-18.4|
70967659|NCT02090413|141441271|SUPERIORITY_OR_OTHER||Difference in percentage|13.7|||||TWO_SIDED|95.0|-1.9|29.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Tingling, Weeks 5-8 combined||29.3|-1.9|
70967660|NCT02090413|141441271|SUPERIORITY_OR_OTHER||Difference in percentage|-5.2|||||TWO_SIDED|95.0|-22.1|11.8|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Tingling, Weeks 9-12 combined||11.8|-22.1|
70967661|NCT02090413|141441271|SUPERIORITY_OR_OTHER||Difference in percentage|7.1|||||TWO_SIDED|95.0|-9.6|23.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Tingling, Weeks 9-12 combined||23.9|-9.6|
70967662|NCT02090413|141441271|SUPERIORITY_OR_OTHER||Difference in percentage|9.4|||||TWO_SIDED|95.0|-6.8|25.5|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Itching, Weeks 5-8 combined||25.5|-6.8|
70967663|NCT02090413|141441271|SUPERIORITY_OR_OTHER||Difference in percentage|9.4|||||TWO_SIDED|95.0|-6.8|25.5|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Itching, Weeks 5-8||25.5|-6.8|
70967664|NCT02090413|141441271|SUPERIORITY_OR_OTHER||Difference in percentage|3.8|||||TWO_SIDED|95.0|-13.2|20.8|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Itching, Weeks 9-12 combined||20.8|-13.2|
70967665|NCT02090413|141441271|SUPERIORITY_OR_OTHER||Difference in percentage|8.4|||||TWO_SIDED|95.0|-8.5|25.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Itching, Weeks 9-12 combined||25.3|-8.5|
70967666|NCT02090413|141441275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.145|||||TWO_SIDED|95.0|-0.414|0.125|||||Analysis of variance model (ANCOVA) model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 1-4 combined||0.125|-0.414|
70967667|NCT02090413|141441275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.392|||||TWO_SIDED|95.0|-0.656|-0.128|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 1-4 combined||-0.128|-0.656|
70967668|NCT02090413|141441275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.247|||||TWO_SIDED|95.0|-0.507|0.012|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 1-4 combined||0.012|-0.507|
70967669|NCT02090413|141441275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.376|||||TWO_SIDED|95.0|-0.193|0.945|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 5-8 combined||0.945|-0.193|
70967670|NCT02090413|141441275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|||||TWO_SIDED|95.0|-0.498|0.635|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 5-8 combined||0.635|-0.498|
70967671|NCT02090413|141441275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.308|||||TWO_SIDED|95.0|-0.867|0.251|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 5-8 combined||0.251|-0.867|
70967672|NCT02090413|141441275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|||||TWO_SIDED|95.0|-0.308|0.355|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 9-12 combined||0.355|-0.308|
70967673|NCT02090413|141441275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|95.0|-0.374|0.254|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 9-12 combined||0.254|-0.374|
70967674|NCT02090413|141441275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.084|||||TWO_SIDED|95.0|-0.4|0.232|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 9-12 combined||0.232|-0.4|
70967675|NCT00487396|141441289|OTHER||||||<|0.0001|||||||McNemar|||"Pathologies were including in the analysis as follows:~* combination of CE+IC procedures but not detected by the combination of SBFT+IC procedures were marked as CE+IC new finding ;~* Pathologies detected by the combination of SBFT+IC procedures but not detected by the combination of CE+IC procedures were marked as SBFT+IC new finding event;~* Pathologies detected by the combination of CE+IC procedures and by the combination of SBFT+IC procedures were marked as same findings event."||||<0.0001
70967676|NCT00487396|141441290|OTHER||||||<|0.0001|||||||McNemar|||"For each category, the numbers of found and missed pathologies were including in the analysis as follows:~* Pathologies detected by CE procedure but not detected by SBFT procedure were marked as CE new finding event;~* Pathologies detected by SBFT procedure but not detected by CE procedure were marked as SBFT new finding event;~* Pathologies detected by both procedures (i.e., CE and SBFT) were marked as same findings event."||||<0.0001
70967677|NCT00487396|141441291|OTHER|||||||0.085|||||||McNemar|||"Pathologies were including in the analysis as follows:~* Pathologies detected by CE procedure but not detected by IC procedure were marked as CE new finding event;~* Pathologies detected by IC procedure but not detected by CE procedure were marked as IC new finding event;~* Pathologies detected by both procedures (i.e., CE and IC) were marked as same findings event."||||0.085
70967678|NCT05321069|141441294|SUPERIORITY||Mean Difference (Net)|44.89||||0.0222|TWO_SIDED|95.0|6.44|83.33|||Mixed Models Analysis|The Kenward-Roger method estimated denominator degrees of freedom and adjusted standard errors; tests used two-sided α per multiple testing strategy.|Adjusted mean difference in FVC change from baseline at Week 52 between the Nera 9 mg bid group and the Placebo group.|Based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of baseline forced vital capacity (FVC) in milliliters at each visit. Patients were treated as a random effect. Visit was treated as the repeated measure, and an unstructured covariance structure was used to model the within-patient measurements.||83.33|6.44|0.0222
70967679|NCT05321069|141441294|SUPERIORITY||Mean Difference (Net)|68.83||||0.0005|TWO_SIDED|95.0|30.26|107.39|||Mixed Models Analysis|The Kenward-Roger method estimated denominator degrees of freedom and adjusted standard errors; tests used two-sided α per multiple testing strategy.|Adjusted mean difference in FVC change from baseline at Week 52 between the Nera 18 mg bid group and the Placebo group.|Based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of baseline forced vital capacity (FVC) in milliliters at each visit. Patients were treated as a random effect. Visit was treated as the repeated measure, and an unstructured covariance structure was used to model the within-patient measurements.||107.39|30.26|0.0005
70967680|NCT05321069|141441295|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.5443|TWO_SIDED|95.0|0.69|1.22|||Regression, Cox|||The hazard ratio (HR) was estimated using a Cox proportional hazards model with treatment group, baseline antifibrotic therapy use, age (continuous), baseline FVC % predicted, and baseline DLCO % predicted (hemoglobin-corrected) as covariates. Breslow's method was applied for tied event times. A two-sided p-value from the Wald test assessed the treatment effect. P-values were not adjusted for multiplicity.||1.22|0.69|0.5443
70967681|NCT05321069|141441295|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9512|TWO_SIDED|95.0|0.75|1.31|||Regression, Cox|||Based on Cox proportional hazards model including treatment, baseline antifibrotic therapy, age, baseline Forced Vital Capacity (FVC) percent predicted, and baseline Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) percent predicted (corrected for haemoglobin) as covariates. p-values not adjusted for multiplicity.||1.31|0.75|0.9512
70967682|NCT05321069|141441296|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.5583|TWO_SIDED|95.0|0.76|1.67|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.67|0.76|0.5583
70967683|NCT05321069|141441296|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.5896|TWO_SIDED|95.0|0.75|1.65|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.65|0.75|0.5896
70967684|NCT05321069|141441297|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.9038|TWO_SIDED|95.0|0.7|1.36|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.36|0.70|0.9038
70967685|NCT05321069|141441297|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.4687|TWO_SIDED|95.0|0.82|1.56|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.56|0.82|0.4687
70967686|NCT05321069|141441298|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.7695|TWO_SIDED|95.0|0.74|1.25|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.25|0.74|0.7695
70967687|NCT05321069|141441298|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.2068|TWO_SIDED|95.0|0.64|1.1|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.10|0.64|0.2068
70967688|NCT05321069|141441299|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.9251|TWO_SIDED|95.0|0.69|1.41|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.41|0.69|0.9251
70967689|NCT05321069|141441299|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.4988|TWO_SIDED|95.0|0.62|1.26|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.26|0.62|0.4988
70967690|NCT05321069|141441300|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.9084|TWO_SIDED|95.0|0.6|1.76|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.76|0.60|0.9084
70967691|NCT05321069|141441300|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.4682|TWO_SIDED|95.0|0.46|1.43|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.43|0.46|0.4682
70967692|NCT05321069|141441301|SUPERIORITY||Mean Difference (Net)|-1.0||||0.3697|TWO_SIDED|95.0|-3.2|1.19|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Dyspnea score) between the Nera 9mg BID group and the Placebo group at Week 52.|The analysis used a Mixed Model for Repeated Measures (MMRM) with fixed categorical effects for treatment group and baseline antifibrotic therapy at each visit, and fixed continuous effects of baseline Living with Pulmonary Fibrosis (L-PF) Dyspnea domain score. An unstructured covariance structure accounted for within-patient correlations. Baseline antifibrotic use, as recorded in the concomitant medication case report form (CRF), was included as a covariate.||1.19|-3.20|0.3697
70967693|NCT05321069|141441301|SUPERIORITY||Mean Difference (Net)|-0.63||||0.5734|TWO_SIDED|95.0|-2.83|1.57|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Dyspnea score) between the Nera 18mg BID group and the Placebo group at Week 52.|The analysis used a Mixed Model for Repeated Measures (MMRM) with fixed categorical effects for treatment group and baseline antifibrotic therapy at each visit, and fixed continuous effects of baseline Living with Pulmonary Fibrosis (L-PF) Dyspnea domain score. An unstructured covariance structure accounted for within-patient correlations. Baseline antifibrotic use, as recorded in the concomitant medication case report form (CRF), was included as a covariate.||1.57|-2.83|0.5734
70967694|NCT05321069|141441302|SUPERIORITY||Mean Difference (Net)|-0.1||||0.9442|TWO_SIDED|95.0|-2.98|2.77|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Cough score) between the Nera 9 mg BID group and the Placebo group at Week 52.|The analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed categorical effects for treatment group at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of the baseline Living with Pulmonary Fibrosis (L-PF) Cough domain score at each visit. An unstructured covariance structure modeled repeated measures. Baseline antifibrotic use, recorded in the concomitant medication case report form (CRF), was included as a covariate.||2.77|-2.98|0.9442
70967695|NCT05321069|141441302|SUPERIORITY||Mean Difference (Net)|-0.59||||0.6862|TWO_SIDED|95.0|-3.47|2.28|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Cough score) between the Nera 18 mg BID group and the Placebo group at Week 52.|The analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed categorical effects for treatment group at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of the baseline Living with Pulmonary Fibrosis (L-PF) Cough domain score at each visit. An unstructured covariance structure modeled repeated measures. Baseline antifibrotic use, recorded in the concomitant medication case report form (CRF), was included as a covariate.||2.28|-3.47|0.6862
70967696|NCT05321069|141441303|SUPERIORITY||Mean Difference (Net)|0.19||||0.8759|TWO_SIDED|95.0|-2.25|2.63|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Fatigue score) between the Nera 9 mg BID group and the Placebo group at Week 52.|The analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed categorical effects for treatment group at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of the baseline Living with Pulmonary Fibrosis (L-PF) Fatigue domain score at each visit. An unstructured covariance structure modeled repeated measures. Baseline antifibrotic use, recorded in the concomitant medication case report form (CRF), was included as a covariate.||2.63|-2.25|0.8759
70967697|NCT05321069|141441303|SUPERIORITY||Mean Difference (Net)|0.43||||0.732|TWO_SIDED|95.0|-2.02|2.87|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Fatigue score) between the Nera 18 mg BID group and the Placebo group at Week 52.|The analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed categorical effects for treatment group at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of the baseline Living with Pulmonary Fibrosis (L-PF) Fatigue domain score at each visit. An unstructured covariance structure modeled repeated measures. Baseline antifibrotic use, recorded in the concomitant medication case report form (CRF), was included as a covariate.||2.87|-2.02|0.7320
70967698|NCT05321069|141441304|SUPERIORITY||Mean Difference (Net)|1.17||||0.028|TWO_SIDED|95.0|0.13|2.22|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in percent predicted Forced Vital Capacity between the Nera 9 mg BID group and the placebo group at Week 52.|"Analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment, baseline use of antifibrotic therapy, and the fixed continuous effects of baseline forced vital capacity (FVC) percentage predicted at each visit. An unstructured covariance structure was used to model repeated measures within patients.~Baseline use of antifibrotic therapy, as recorded in the concomitant medication case report form (CRF) page, was included as a covariate."||2.22|0.13|0.0280
70967699|NCT05321069|141441304|SUPERIORITY||Mean Difference (Net)|1.73||||0.0013|TWO_SIDED|95.0|0.68|2.78|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in percent predicted Forced Vital Capacity between the Nera 18 mg BID group and the placebo group at Week 52.|"Analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment, baseline use of antifibrotic therapy, and the fixed continuous effects of baseline forced vital capacity (FVC) percentage predicted at each visit. An unstructured covariance structure was used to model repeated measures within patients.~Baseline use of antifibrotic therapy, as recorded in the concomitant medication case report form (CRF) page, was included as a covariate."||2.78|0.68|0.0013
70967700|NCT05321069|141441305|SUPERIORITY||Mean Difference (Net)|2.49||||0.0042|TWO_SIDED|95.0|0.79|4.19|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in percent predicted DLCO between the Nera 9 mg BID group and the placebo group at Week 52.|"Based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment, baseline use of antifibrotic therapy, and the fixed continuous effects of baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted at each visit. An unstructured covariance structure was used to model repeated measures within patients.~Baseline use of antifibrotic therapy, as recorded in the concomitant medication CRF page, was included as a covariate."||4.19|0.79|0.0042
70967701|NCT05321069|141441305|SUPERIORITY||Mean Difference (Net)|1.67||||0.053|TWO_SIDED|95.0|-0.02|3.37|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in percent predicted DLCO between the Nera 18 mg BID group and the placebo group at Week 52.|"Based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment, baseline use of antifibrotic therapy, and the fixed continuous effects of baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted at each visit. An unstructured covariance structure was used to model repeated measures within patients.~Baseline use of antifibrotic therapy, as recorded in the concomitant medication CRF page, was included as a covariate."||3.37|-0.02|0.0530
70967702|NCT00597753|141441327|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 95% confidence interval for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ -1.0 g/dL.|Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.072|||TWO_SIDED|95.0|-0.3|-0.01|||ANOVA|The ANOVA cell means model was used to estimate primary efficacy endpoint within the specified cells formed by the combination of treatment and strata||The sample size for this study was determined based on a two group evaluation of non-inferiority using the t-distribution (one-sided significance level 0.025) with a non inferiority margin of -1.0 g/dL. A sample size of approximately 750 (peginesatide group of 500 and epoetin alfa group of 250) provided at least 99% power for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a standard deviation of 1.5 g/dL.||-0.01|-0.30|
70967703|NCT00597753|141441328|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.21|||||TWO_SIDED|95.0|0.76|1.92|||Cochran-Mantel-Haenszel|||||1.92|0.76|
70967704|NCT00597753|141441329|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.79|0.97|||Cochran-Mantel-Haenszel|||||0.97|0.79|
70967705|NCT03451851|141441330|SUPERIORITY||Difference in percentage|49.9|||<|0.001|TWO_SIDED|95.0|25.9|69.4|||Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||69.4|25.9|<0.001
70967706|NCT03451851|141441331|SUPERIORITY||Difference in percentage|55.6|||<|0.001|TWO_SIDED|95.0|32.1|74.0|||Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||74.0|32.1|<0.001
70967707|NCT03451851|141441332|SUPERIORITY||Difference in percentage|40.1|||=|0.003|TWO_SIDED|95.0|15.6|61.3|||Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||61.3|15.6|=0.003
70967708|NCT03451851|141441333|SUPERIORITY||Difference in percentage|35.0|||=|0.004|TWO_SIDED|95.0|10.5|56.8|||Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||56.8|10.5|=0.004
70967709|NCT03451851|141441334|SUPERIORITY||Difference in percentage|34.1|||=|0.002|TWO_SIDED|25.0|9.7|56.1|||Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||56.1|9.7|=0.002
70967710|NCT03451851|141441335|SUPERIORITY||LS Mean difference|-5.4|||<|0.001|TWO_SIDED|95.0|-7.33|-3.06|||Mixed model repeated measures (MMRM)|||Guselkumab Vs Placebo||-3.06|-7.33|<0.001
70967711|NCT03451851|141441341|SUPERIORITY||Difference in percentage|59.8|||<|0.001|TWO_SIDED|95.0|36.9|77.6||p-value is nominal|Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||77.6|36.9|<0.001
70967712|NCT03451851|141441349|SUPERIORITY||Difference in percentage|46.7|||=|0.002|TWO_SIDED|95.0|21.9|67.3||p-value is nominal|Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||||67.3|21.9|=0.002
70967713|NCT03451851|141441351|SUPERIORITY||Difference in Percentage|23.1|||=|0.139|TWO_SIDED|95.0|-3.4|47.0||p-value is nominal|Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||47.0|-3.4|=0.139
70967714|NCT03451851|141441353|SUPERIORITY||Difference in LS Mean|-5.44|||<|0.001|TWO_SIDED|95.0|-8.0|-2.87||p-value is nominal|MMRM model|||Guselkumab Vs Placebo||-2.87|-8.00|<0.001
70967715|NCT03451851|141441355|SUPERIORITY||LS Mean difference|-14.78|||<|0.001|TWO_SIDED|95.0|-20.28|-9.28||p-value is nominal|MMRM model|||Guselkumab Vs Placebo||-9.28|-20.28|<0.001
70967716|NCT05885737|141441365|EQUIVALENCE|Testing of primary efficacy endpoint was 2-sided and conducted at the 5% significance level. The efficacy of difelikefalin was to be declared for this study if null hypothesis of no treatment difference in the primary efficacy analysis was rejected in favor of the alternative that participants randomized to difelikefalin experience significantly different itching compared to participants randomized to placebo. The null hypothesis was to be rejected if the 2-sided p value was less than (\<) 0.05.|Least square mean difference|-0.81|STANDARD_ERROR_OF_MEAN|0.223||0.0003|TWO_SIDED|95.0|-1.25|-0.37|||MMRM|||The null hypothesis in this study was that there was no treatment difference in the primary efficacy analysis of the primary endpoint. The alternative hypothesis was that in participants randomized to difelikefalin there was a significant treatment difference in change in itching compared to participants randomized to placebo. The assessment was based on the mean change from baseline in the weekly mean of the daily 24-hour WI-NRS score at Week 4 of the DB period.||-0.37|-1.25|0.0003
70967717|NCT01469182|141441416|SUPERIORITY_OR_OTHER||Percent Difference|9.95||||0.005|TWO_SIDED|95.0|3.1|16.7|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||16.7|3.1|0.005
70967718|NCT01469182|141441417|SUPERIORITY_OR_OTHER||Percent Difference|5.58|||<|0.001|TWO_SIDED|95.0|2.9|8.2|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||8.2|2.9|<0.001
70967719|NCT01469182|141441418|SUPERIORITY_OR_OTHER||Percent Difference|7.88|||<|0.001|TWO_SIDED|95.0|5.5|10.5|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||10.5|5.5|<0.001
70967720|NCT01469182|141441419|SUPERIORITY_OR_OTHER||Percent Difference|10.17|||<|0.001|TWO_SIDED|95.0|6.6|13.6|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||13.6|6.6|<0.001
70967721|NCT01469182|141441420|SUPERIORITY_OR_OTHER||Percent Difference|5.25|||<|0.001|TWO_SIDED|95.0|3.3|7.4|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||7.4|3.3|<0.001
70967722|NCT01469182|141441421|SUPERIORITY_OR_OTHER||Percent Difference|0.17||||0.861|TWO_SIDED|95.0|-2.1|1.9|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||1.9|-2.1|0.861
70967723|NCT01469182|141441422|SUPERIORITY_OR_OTHER||Percent Difference|1.15||||0.344||95.0|-1.5|3.3|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||3.3|-1.5|0.344
70967724|NCT01469182|141441423|SUPERIORITY_OR_OTHER||Percent Difference|0.99||||0.382|TWO_SIDED|95.0|-1.5|3.0|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||3.0|-1.5|0.382
70967725|NCT01469182|141441424|SUPERIORITY_OR_OTHER||Percent Difference|2.46||||0.029|TWO_SIDED|95.0|0.3|4.4|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||4.4|0.3|0.029
70967726|NCT02114164|141441425|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70967727|NCT02114164|141441426|OTHER|||||||0.39|||||||t-test, 2 sided|||||||0.39
70967728|NCT02114164|141441427|OTHER|||||||0.13||||||Comparison at baseline|t-test, 2 sided|||||||0.13
70967729|NCT02114164|141441427|OTHER|||||||0.018||||||Comparison at 60 minutes|t-test, 2 sided|||||||0.018
70967730|NCT02114164|141441427|OTHER|||||||0.712||||||Comparison at end of procedure|t-test, 2 sided|||||||0.712
70967731|NCT02114164|141441428|OTHER|||||||0.42||||||Comparison at baseline|t-test, 2 sided|||||||0.42
70967732|NCT02114164|141441428|OTHER|||||||0.75||||||Comparison at 60 minutes|t-test, 2 sided|||||||0.75
70967733|NCT02114164|141441428|OTHER|||||||0.99||||||Comparison at end of procedure|t-test, 2 sided|||||||0.99
70967734|NCT02114164|141441429|OTHER|||||||0.88||||||Comparison at baseline|t-test, 2 sided|||||||0.88
70967735|NCT02114164|141441429|OTHER|||||||0.65||||||Comparison at 60 minutes|t-test, 2 sided|||||||0.65
70967736|NCT02114164|141441429|OTHER|||||||0.86||||||Comparison at end of procedure|t-test, 2 sided|||||||0.86
70967737|NCT02114164|141441430|OTHER|Number of interventions required by the anesthesiologists were compared between the AirSeal and standard Endopath groups using zero-inflated Poisson regression||||||0.41|||||||Zero-inflated Poisson regression|||||||0.41
70967738|NCT02114164|141441431|OTHER|||||||0.09|||||||t-test, 2 sided|||||||0.09
70967739|NCT02114164|141441432|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
70967740|NCT02687542|141441433|OTHER|Bayesian Dose Response Analysis|Bayesian Dose Reponse Estimate|-0.693|STANDARD_ERROR_OF_MEAN|0.6162||0.5776|TWO_SIDED|90.0|-1.713|0.304||Bayesian Predictive Test for Emax (the additive increase over Placebo in the response of PF-06649751 at a theoretically infinite dose) Monotonicity|Bayesian Dose Response Analysis|Estimate and 90% credible interval of Bayesian dose response difference from placebo||||0.304|-1.713|0.5776
70967741|NCT01360554|141441495|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.933||||0.195|TWO_SIDED|95.0|0.797|1.093||One-sided P-value.|1-sided stratified log-rank test|Stratified by epidermal growth factor receptor (EGFR) status, Kirsten Rat Sarcoma status (KRAS), baseline Eastern Cooperative Oncology Group (ECOG).|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status, KRAS, baseline ECOG as stratification factors.|||1.093|0.797|0.195
70967742|NCT01360554|141441496|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.037||||0.643|TWO_SIDED|95.0|0.848|1.268||One-sided P-value|1-sided stratified log-rank test|Stratified by EGFR status and baseline ECOG.|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status and baseline ECOG as stratification factors.|||1.268|0.848|0.643
70967743|NCT01360554|141441497|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.899||||0.069|TWO_SIDED|95.0|0.78|1.035||Stratified by EGFR status, KRAS status, and baseline ECOG.|1-sided stratified log-rank test|One-sided P-value|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status, KRAS status, and baseline ECOG as stratification factors.|||1.035|0.780|0.069
70967744|NCT01360554|141441498|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.057||||0.728|TWO_SIDED|95.0|0.881|1.267||One-sided P-value.|1-sided stratified log-rank test|Stratified by EGFR status and baseline ECOG.|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status and baseline ECOG as stratification factors.|||1.267|0.881|0.728
70967745|NCT01360554|141441499|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.026||||0.638|TWO_SIDED|95.0|0.887|1.188||One-sided P-value.|1-sided stratified log-rank test.|Stratified by EGFR status, KRAS status, and baseline ECOG.|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status, KRAS status, and baseline ECOG as stratification factors.|||1.188|0.887|0.638
70967746|NCT01360554|141441500|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.078||||0.775|TWO_SIDED|95.0|0.886|1.312||One-sided P-value.|1-sided stratified log-rank test.|Stratified by EGFR status and baseline ECOG.|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status and baseline ECOG as stratification factors.|||1.312|0.886|0.775
70967747|NCT01360554|141441508|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.9357||||||95.0|-4.278|0.407|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Global QoL. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||0.407|-4.278|
70967748|NCT01360554|141441508|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|0.8067||||||95.0|-1.312|2.926|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 cognitive functioning. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||2.926|-1.312|
70967749|NCT01360554|141441508|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model|0.73||||||95.0|-1.575|3.035|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 emotional functioning. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||3.035|-1.575|
70967750|NCT01360554|141441508|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|1.5289||||||95.0|-0.756|3.814|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 physical functioning. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||3.814|-0.756|
70967751|NCT01360554|141441508|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|1.2219||||||95.0|-1.975|4.419|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 role functioning. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||4.419|-1.975|
70967752|NCT01360554|141441508|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.497||||||95.0|-4.575|1.581|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 social functioning. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.581|-4.575|
70967753|NCT01360554|141441509|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|1.2851|||||TWO_SIDED|95.0|-2.416|4.986|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Appetite loss. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||4.986|-2.416|
70967754|NCT01360554|141441509|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-5.923|||||TWO_SIDED|95.0|-8.432|-3.414|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Constipation. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||-3.414|-8.432|
70967755|NCT01360554|141441509|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model|20.2564|||||TWO_SIDED|95.0|16.874|23.639|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Diarrhea. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||23.639|16.874|
70967756|NCT01360554|141441509|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-4.5499|||||TWO_SIDED|95.0|-7.719|-1.381|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Dysponea. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||-1.381|-7.719|
70967757|NCT01360554|141441509|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.6584|||||TWO_SIDED|95.0|-4.442|1.125|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Fatigue. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.125|-4.442|
70967758|NCT01360554|141441509|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-0.1469||||||95.0|-3.056|2.762|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Financial Difficulties. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||2.762|-3.056|
70967759|NCT01360554|141441509|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-4.8711|||||TWO_SIDED|95.0|-7.998|-1.745|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Insomnia. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||-1.745|-7.998|
70967760|NCT01360554|141441509|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-0.4924|||||TWO_SIDED|95.0|-2.485|1.5|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Nausea and Vomiting. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.500|-2.485|
70967761|NCT01360554|141441509|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|0.3096|||||TWO_SIDED|95.0|-2.646|3.265|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Pain. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||3.265|-2.646|
70967762|NCT01360554|141441510|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|2.6381||||||95.0|0.172|5.104|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Trouble Swallowing as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||5.104|0.172|
70967763|NCT01360554|141441510|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-4.2504||||||95.0|-7.178|-1.322|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Coughing as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||-1.322|-7.178|
70967764|NCT01360554|141441510|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model|-1.0764||||||95.0|-3.997|1.845|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Haemoptysis as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.845|-3.997|
70967765|NCT01360554|141441510|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|9.3545||||||95.0|6.211|12.497|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Sore Mouth as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||12.497|6.211|
70967766|NCT01360554|141441510|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.1762||||||95.0|-3.56|1.208|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Shortness of Breath as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.208|-3.560|
70967767|NCT01360554|141441510|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-0.6378||||||95.0|-3.684|2.408|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Peripheral Neuropathy as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||2.408|-3.684|
70967768|NCT01360554|141441510|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.3637||||||95.0|-4.546|1.819|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Alopecia as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.819|-4.546|
70967769|NCT01360554|141441510|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.2163||||||95.0|-3.885|1.452|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Pain in Chest as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.452|-3.885|
70967770|NCT01360554|141441510|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.1475||||||95.0|-3.902|1.607|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Pain in Arm or Shoulder as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.607|-3.902|
70967771|NCT01360554|141441510|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.0687||||||95.0|-4.488|2.351|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Pain Other Parts as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||2.351|-4.488|
70967772|NCT01360554|141441510|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|0.0322||||||95.0|-4.847|4.911|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Any Med for Pain as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||4.911|-4.847|
70967773|NCT01360554|141441511|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-0.3886||||||95.0|-2.413|1.636|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for EQ-5D VAS. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.636|-2.413|
70967774|NCT00111800|141441524|SUPERIORITY||Mean Difference (Net)|-0.28||||0.061|TWO_SIDED|95.0|-0.58|0.01|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.01|-0.58|0.061
70967775|NCT00111800|141441524|SUPERIORITY||Mean Difference (Net)|-0.53|||<|0.001|TWO_SIDED|95.0|-0.82|-0.24|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.24|-0.82|<0.001
70967776|NCT00111800|141441524|SUPERIORITY||Mean Difference (Net)|-0.45||||0.002|TWO_SIDED|95.0|-0.74|-0.16|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.16|-0.74|0.002
70967777|NCT00111800|141441524|SUPERIORITY||Mean Difference (Net)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.09|-0.5|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.50|-1.09|<0.001
70967778|NCT00111800|141441524|SUPERIORITY||Mean Difference (Net)|-0.84|||<|0.001|TWO_SIDED|95.0|-1.13|-0.55|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.55|-1.13|<0.001
70967779|NCT00111800|141441526|SUPERIORITY||Mean Difference (Net)|-0.4||||0.306|TWO_SIDED|95.0|-1.18|0.37|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.37|-1.18|0.306
70967780|NCT00111800|141441526|SUPERIORITY||Mean Difference (Net)|-0.8||||0.039|TWO_SIDED|95.0|-1.56|-0.04|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.04|-1.56|0.039
70967781|NCT00111800|141441526|SUPERIORITY||Mean Difference (Net)|-0.58||||0.13|TWO_SIDED|95.0|-1.34|0.17|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.17|-1.34|0.130
70967782|NCT00111800|141441526|SUPERIORITY||Mean Difference (Net)|-1.46|||<|0.001|TWO_SIDED|95.0|-2.23|-0.69|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.69|-2.23|<0.001
70967783|NCT00111800|141441526|SUPERIORITY||Mean Difference (Net)|-1.22||||0.002|TWO_SIDED|95.0|-1.99|-0.46|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.46|-1.99|0.002
70967784|NCT00111800|141441528|SUPERIORITY||Odds Ratio (OR)|0.92||||0.909|TWO_SIDED|95.0|0.21|3.95|||Regression, Logistic|||Placebo versus DEN 2.5 mg for HbA1c \<=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||3.95|0.21|0.909
70967785|NCT00111800|141441528|SUPERIORITY||Odds Ratio (OR)|1.15||||0.852|TWO_SIDED|95.0|0.27|4.92|||Regression, Logistic|||Placebo versus DEN 7.5 mg for HbA1c \<=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||4.92|0.27|0.852
70967786|NCT00111800|141441528|SUPERIORITY||Odds Ratio (OR)|1.2||||0.795|TWO_SIDED|95.0|0.3|4.83|||Regression, Logistic|||Placebo versus DEN 15 mg for HbA1c \<=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||4.83|0.30|0.795
70967787|NCT00111800|141441528|SUPERIORITY||Odds Ratio (OR)|2.68||||0.135|TWO_SIDED|95.0|0.74|9.77|||Regression, Logistic|||Placebo versus DEN 30 mg for HbA1c \<=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.77|0.74|0.135
70967788|NCT00111800|141441528|SUPERIORITY||Odds Ratio (OR)|3.24||||0.085|TWO_SIDED|95.0|0.85|12.37|||Regression, Logistic|||Placebo versus DEN 45 mg for HbA1c \<=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||12.37|0.85|0.085
70967789|NCT00111800|141441528|SUPERIORITY||Odds Ratio (OR)|1.1||||0.866|TWO_SIDED|95.0|0.36|3.36|||Regression, Logistic|||Placebo versus DEN 2.5 mg for HbA1c \<7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||3.36|0.36|0.866
70967790|NCT00111800|141441528|SUPERIORITY||Odds Ratio (OR)|1.99||||0.202|TWO_SIDED|95.0|0.69|5.76|||Regression, Logistic|||Placebo versus DEN 7.5 mg for HbA1c \<7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||5.76|0.69|0.202
70967791|NCT00111800|141441528|SUPERIORITY||Odds Ratio (OR)|1.04||||0.941|TWO_SIDED|95.0|0.35|3.13|||Regression, Logistic|||Placebo versus DEN 15 mg for HbA1c \<7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||3.13|0.35|0.941
70967792|NCT00111800|141441528|SUPERIORITY||Odds Ratio (OR)|2.15||||0.152|TWO_SIDED|95.0|0.76|6.13|||Regression, Logistic|||Placebo versus DEN 30 mg for HbA1c \<7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||6.13|0.76|0.152
70967793|NCT00111800|141441528|SUPERIORITY||Odds Ratio (OR)|3.24||||0.032|TWO_SIDED|95.0|1.11|9.52|||Regression, Logistic|||Placebo versus DEN 45 mg for HbA1c \<7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.52|1.11|0.032
70967794|NCT00111800|141441528|SUPERIORITY||Odds Ratio (OR)|0.46||||0.198|TWO_SIDED|95.0|0.14|1.5|||Regression, Logistic|||Placebo versus DEN 2.5 mg for HbA1c reduction \>=0.7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||1.50|0.14|0.198
70967795|NCT00111800|141441528|SUPERIORITY||Odds Ratio (OR)|1.43||||0.481|TWO_SIDED|95.0|0.53|3.85|||Regression, Logistic|||Placebo versus DEN 7.5 mg for HbA1c reduction \>=0.7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||3.85|0.53|0.481
70967796|NCT00111800|141441528|SUPERIORITY||Odds Ratio (OR)|1.01||||0.991|TWO_SIDED|95.0|0.36|2.78|||Regression, Logistic|||Placebo versus DEN 15 mg for HbA1c reduction \>=0.7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||2.78|0.36|0.991
70967797|NCT00111800|141441528|SUPERIORITY||Odds Ratio (OR)|3.65||||0.008|TWO_SIDED|95.0|1.41|9.48|||Regression, Logistic|||Placebo versus DEN 30 mg for HbA1c reduction \>=0.7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.48|1.41|0.008
70967798|NCT00111800|141441528|SUPERIORITY||Odds Ratio (OR)|2.0||||0.161|TWO_SIDED|95.0|0.76|5.24|||Regression, Logistic|||Placebo versus DEN 45 mg for HbA1c reduction \>=0.7%. A closed test procedure was used,P an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||5.24|0.76|0.161
70967799|NCT00111800|141441529|SUPERIORITY||Odds Ratio (OR)|1.77||||0.38|TWO_SIDED|95.0|0.5|6.3|||Regression, Logistic|||Placebo versus DEN 2.5 mg for FPG \<7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||6.30|0.50|0.380
70967800|NCT00111800|141441529|SUPERIORITY||Odds Ratio (OR)|2.57||||0.145|TWO_SIDED|95.0|0.72|9.11|||Regression, Logistic|||Placebo versus DEN 7.5 mg for FPG \<7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.11|0.72|0.145
70967801|NCT00111800|141441529|SUPERIORITY||Odds Ratio (OR)|1.09||||0.906|TWO_SIDED|95.0|0.26|4.62|||Regression, Logistic|||Placebo versus DEN 15 mg for FPG \<7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||4.62|0.26|0.906
70967802|NCT00111800|141441529|SUPERIORITY||Odds Ratio (OR)|1.56||||0.509|TWO_SIDED|95.0|0.41|5.91|||Regression, Logistic|||Placebo versus DEN 30 mg for FPG \<7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||5.91|0.41|0.509
70967803|NCT00111800|141441529|SUPERIORITY||Odds Ratio (OR)|3.14||||0.077|TWO_SIDED|95.0|0.89|11.14|||Regression, Logistic|||Placebo versus DEN 45 mg for FPG \<7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||11.14|0.89|0.077
70967804|NCT00111800|141441529|SUPERIORITY||Odds Ratio (OR)|1.9||||0.254|TWO_SIDED|95.0|0.63|5.72|||Regression, Logistic|||Placebo versus DEN 2.5 mg for FPG reduction \>=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||5.72|0.63|0.254
70967805|NCT00111800|141441529|SUPERIORITY||Odds Ratio (OR)|1.59||||0.396|TWO_SIDED|95.0|0.55|4.62|||Regression, Logistic|||Placebo versus DEN 7.5 mg for FPG reduction \>=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||4.62|0.55|0.396
70967806|NCT00111800|141441529|SUPERIORITY||Odds Ratio (OR)|1.35||||0.59|TWO_SIDED|95.0|0.45|4.0|||Regression, Logistic|||Placebo versus DEN 15 mg for FPG reduction \>=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||4.00|0.45|0.590
70967807|NCT00111800|141441529|SUPERIORITY||Odds Ratio (OR)|3.24||||0.026|TWO_SIDED|95.0|1.15|9.13|||Regression, Logistic|||Placebo versus DEN 30 mg for FPG reduction \>=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.13|1.15|0.026
70967808|NCT00111800|141441529|SUPERIORITY||Odds Ratio (OR)|3.0||||0.034|TWO_SIDED|95.0|1.08|8.3|||Regression, Logistic|||Placebo versus DEN 45 mg for FPG reduction \>=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||8.30|1.08|0.034
70967809|NCT00111800|141441530|SUPERIORITY||Mean Difference (Net)|-14.9||||0.057||95.0|-30.2|0.5|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.5|-30.2|0.057
70967810|NCT00111800|141441530|SUPERIORITY||Mean Difference (Net)|-22.4||||0.003||95.0|-37.1|-7.6|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-7.6|-37.1|0.003
70967811|NCT00111800|141441530|SUPERIORITY||Mean Difference (Net)|-29.2|||<|0.001||95.0|-43.9|-14.5|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-14.5|-43.9|<0.001
70967812|NCT00111800|141441530|SUPERIORITY||Mean Difference (Net)|-39.6|||<|0.001|TWO_SIDED|95.0|-54.6|-24.6|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-24.6|-54.6|<0.001
70967813|NCT00111800|141441530|SUPERIORITY||Mean Difference (Net)|-38.9|||<|0.001|TWO_SIDED|95.0|-53.8|-23.9|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-23.9|-53.8|<0.001
70967814|NCT00111800|141441532|SUPERIORITY||Mean Difference (Net)|-8.51||||0.489|TWO_SIDED|95.0|-32.66|15.65|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg for fasting serum insulin.|Placebo versus DEN 2.5 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||15.65|-32.66|0.489
70967815|NCT00111800|141441532|SUPERIORITY||Mean Difference (Net)|14.18||||0.237|TWO_SIDED|95.0|-9.37|37.72|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg for fasting serum insulin.|Placebo versus DEN 7.5 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||37.72|-9.37|0.237
70967816|NCT00111800|141441532|SUPERIORITY||Mean Difference (Net)|7.31||||0.534||95.0|-15.79|30.42|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg for fasting serum insulin.|Placebo versus DEN 15 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||30.42|-15.79|0.534
70967817|NCT00111800|141441532|SUPERIORITY||Mean Difference (Net)|5.27||||0.665|TWO_SIDED|95.0|-18.64|29.17|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg for fasting serum insulin.|Placebo versus DEN 30 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||29.17|-18.64|0.665
70967818|NCT00111800|141441532|SUPERIORITY||Mean Difference (Net)|12.74||||0.295|TWO_SIDED|95.0|-11.18|36.65|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg for fasting serum insulin.|Placebo versus DEN 45 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||36.65|-11.18|0.295
70967819|NCT00111800|141441532|SUPERIORITY||Mean Difference (Net)|3.31||||0.327|TWO_SIDED|95.0|-3.32|9.94|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg for pro-insulin.|Placebo versus DEN 2.5 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.94|-3.32|0.327
70967820|NCT00111800|141441532|SUPERIORITY||Mean Difference (Net)|3.06||||0.345|TWO_SIDED|95.0|-3.31|9.44|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg for pro-insulin.|Placebo versus DEN 7.5 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.44|-3.31|0.345
70967821|NCT00111800|141441532|SUPERIORITY||Mean Difference (Net)|-0.35||||0.914|TWO_SIDED|95.0|-6.7|6.0|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg for pro-insulin.|Placebo versus DEN 15 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||6.00|-6.70|0.914
70967822|NCT00111800|141441532|SUPERIORITY||Mean Difference (Net)|-2.21||||0.504|TWO_SIDED|95.0|-8.71|4.29|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg for pro-insulin.|Placebo versus DEN 30 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||4.29|-8.71|0.504
70967823|NCT00111800|141441532|SUPERIORITY||Mean Difference (Net)|2.75||||0.403|TWO_SIDED|95.0|-3.71|9.22|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg for pro-insulin.|Placebo versus DEN 45 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.22|-3.71|0.403
70967824|NCT00111800|141441535|SUPERIORITY||Mean Difference (Net)|0.03||||0.286|TWO_SIDED|95.0|-0.02|0.08|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.08|-0.02|0.286
70967825|NCT00111800|141441535|SUPERIORITY||Mean Difference (Net)|-0.02||||0.457|TWO_SIDED|95.0|-0.07|0.03|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.03|-0.07|0.457
70967826|NCT00111800|141441535|SUPERIORITY||Mean Difference (Net)|-0.04||||0.136|TWO_SIDED|95.0|-0.09|0.01|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.01|-0.09|0.136
70967827|NCT00111800|141441535|SUPERIORITY||Mean Difference (Net)|-0.06||||0.021|TWO_SIDED|95.0|-0.11|-0.01|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.01|-0.11|0.021
70967828|NCT00111800|141441535|SUPERIORITY||Mean Difference (Net)|-0.04||||0.094|TWO_SIDED|95.0|-0.09|0.01|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.01|-0.09|0.094
70967829|NCT01549275|141441551|SUPERIORITY_OR_OTHER||||||<|0.005|TWO_SIDED||||||Chi-squared|degrees of freedom =1||Null hypothesis: There is no significant difference in the incidence of patients with rapidly proliferative cultured cells between two groups.||||< 0.005
70967830|NCT01549275|141441551|SUPERIORITY_OR_OTHER||||||<|0.005|TWO_SIDED||||||Chi-squared|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of patients with rapidly proliferative cultured HCC cells with or without concomitant cancer-associated fibroblasts between two groups.||||< 0.005
70967831|NCT01549275|141441551|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||Chi-squared|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of patients with rapidly proliferative cultured cancer-associated fibroblasts alone between two groups.||||> 0.1
70967832|NCT01549275|141441552|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|degrees of freedom = 1||null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative cultured cells.||||1
70967833|NCT01549275|141441552|SUPERIORITY_OR_OTHER|||||||0.032|TWO_SIDED||||||Fisher Exact|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative cultured cells.||||0.032
70967834|NCT01549275|141441552|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||Fisher Exact|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative cultured cells.||||0.048
70967835|NCT01549275|141441552|SUPERIORITY_OR_OTHER|||||||0.176|TWO_SIDED||||||Fisher Exact|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative cultured cells.||||0.176
70967836|NCT01549275|141441552|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Fisher Exact|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative HCC cultured cells.||||0.021
70967837|NCT01549275|141441552|SUPERIORITY_OR_OTHER|||||||0.129|TWO_SIDED||||||Fisher Exact|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative cultured cells.||||0.129
70967838|NCT03448068|141441553|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
70967839|NCT03448068|141441554|SUPERIORITY|||||||0.2252|||||||t-test, 2 sided|||||||0.2252
70967840|NCT03448068|141441555|SUPERIORITY|||||||0.061|||||||t-test, 2 sided|||||||0.0610
70967841|NCT03448068|141441556|SUPERIORITY|||||||0.272|||||||t-test, 2 sided|||||||0.2720
70967842|NCT03448068|141441557|SUPERIORITY|||||||0.7298|||||||Chi-squared|||Nausea 1st 12 hours for Ketamine Therapy vs Standard Therapy||||0.7298
70967843|NCT03448068|141441557|SUPERIORITY|||||||0.1058|||||||Chi-squared|||Nausea 2nd 12 hours for Ketamine Therapy vs Standard Therapy||||0.1058
70967844|NCT03448068|141441557|SUPERIORITY|||||||1|||||||Chi-squared|||Nausea 2nd 24 hours for Ketamine Therapy vs Standard Therapy||||1.000
70967845|NCT03448068|141441558|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.2
70967846|NCT02113436|141441561|SUPERIORITY_OR_OTHER||Difference in Least square means|-0.97||||0.206|TWO_SIDED|95.0|-2.47|0.54|||ANCOVA|||||0.54|-2.47|0.206
70967847|NCT02113436|141441562|SUPERIORITY_OR_OTHER||Difference in Least sqaure means|-0.49||||0.235|TWO_SIDED|95.0|-1.29|0.32|||ANCOVA|||||0.32|-1.29|0.235
70967848|NCT02113436|141441563|SUPERIORITY_OR_OTHER||Difference in Least-Sqaure means|-0.48||||0.236|TWO_SIDED|95.0|-1.27|0.31|||ANCOVA|||||0.31|-1.27|0.236
70967849|NCT02113436|141441564|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47|||||TWO_SIDED|95.0|0.14|1.6||||||||1.60|0.14|
70967850|NCT02113436|141441565|SUPERIORITY_OR_OTHER||Difference in Least-Square Means|0.7||||0.041|TWO_SIDED|95.0|0.0|1.4|||ANCOVA|||||1.4|0.0|0.041
70967851|NCT02113436|141441566|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-0.06||||0.335|TWO_SIDED|95.0|-0.2|0.07|||ANCOVA|||||0.07|-0.20|0.335
70967852|NCT02113436|141441567|SUPERIORITY_OR_OTHER||Difference in Least Square Means|2.6||||0.389|TWO_SIDED|95.0|-3.3|8.6|||ANCOVA|||||8.6|-3.3|0.389
70967853|NCT01486927|141441583|SUPERIORITY_OR_OTHER||Rate ratio|0.08|||<|0.0001|TWO_SIDED|95.0|0.07|0.1|||Poisson, regression|||A test of the null hypothesis of no difference on AsBR between the 2 comparison groups was based on the Poisson Regression method. The corresponding prophylaxis/on-demand ratio with 95% confidence interval (CI) was calculated.||0.10|0.07|< 0.0001
70967854|NCT00365456|141441603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.012|STANDARD_ERROR_OF_MEAN|1.0045||0.01|TWO_SIDED|95.0|1.003|1.021||No multiplicity correction of the significance level was performed as only one primary endpoint was planned.|ANCOVA|Estimation allowing for unequal variance in the two treatment groups and robust estimates for the standard errors were obtained.||An analysis of covariance (ANCOVA) model was used including treatment group, stratum and pooled centre as fixed effects and log (BMD at Baseline III (month 24)) as a covariate (log-normally distributed data assumed). Least square mean change from baseline III (month 24), 95% confidence interval and p-value for the treatment effect (PTH (1-84) vs. Risedronate) was calculated. Superiority was claimed if lower limit of the interval was above 1. Results were back-transformed from the log scale.||1.021|1.003|0.010
70967855|NCT01476475|141441606|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority of insulin glargine/lixisenatide FRC versus insulin glargine was tested first, at alpha level of 0.025 (1-sided) and a non-inferiority margin of 0.4% HbA1c. If non-inferiority was established, then a test of superiority of insulin glargine/lixisenatide FRC over insulin glargine would be performed, at alpha level of 0.05 (2-sided). The non-inferiority was assessed using upper bound of 2-sided 95% confidence interval (CI) at ≤0.4%.|Least square (LS) mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|95.0|-0.312|-0.037|||ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of screening HbA1c (\<8.0, ≥8.0%), randomization strata of screening BMI (\<30 kg/m\^2, ≥30 kg/m\^2), and country as fixed effects and baseline HbA1c value as covariates. A step-down testing procedure described by Hochberg and Tamhane was used to control type-1 error.||-0.037|-0.312|
70967856|NCT01476475|141441606|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.013|TWO_SIDED|95.0|-0.312|-0.037||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c (\<8.0, ≥8.0%), randomization strata of screening BMI (\<30 kg/m\^2, ≥30 kg/m\^2), and country as fixed effects and baseline HbA1c value as covariates. If non-inferiority was established, then a test of superiority of insulin glargine/lixisenatide FRC over insulin glargine would be performed, at alpha level of 0.05 (2-sided).||-0.037|-0.312|0.0130
70967857|NCT01476475|141441607|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.17|STANDARD_ERROR_OF_MEAN|0.337|<|0.0001|TWO_SIDED|95.0|-3.832|-2.504||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Analysis was performed using ANCOVA with treatment groups,randomization strata of screening HbA1c(\<8.0, ≥8.0%)\& screening BMI(\<30 kg/m\^2, ≥30 kg/m\^2),country as fixed effects and baseline 2-hour PPG value as covariates.A step-down testing procedure used to control type-1 error.If non-inferiority demonstrated for primary endpoint,superiority testing on secondary endpoints was performed sequentially in order endpoints are reported(continued only if previous endpoint was statistically significant).||-2.504|-3.832|<0.0001
70967858|NCT01476475|141441608|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.24|STANDARD_ERROR_OF_MEAN|0.331|<|0.0001|TWO_SIDED|95.0|-3.895|-2.592||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the step-down testing procedure (continued only if previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c (\<8.0, ≥8.0%), randomization strata of screening BMI (\<30 kg/m\^2, ≥30 kg/m\^2), and country as fixed effects and baseline 2-hour plasma glucose excursion value as covariates.||-2.592|-3.895|<0.0001
70967859|NCT01476475|141441609|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.125||0.0154|TWO_SIDED|95.0|-0.55|-0.058||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the step-down testing procedure (continued only if previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c (\<8.0, ≥8.0%), randomization strata of screening BMI (\<30 kg/m\^2, ≥30 kg/m\^2), and country as fixed effects and baseline average 7-point SMPG value as covariates.||-0.058|-0.550|0.0154
70967860|NCT01476475|141441610|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|0.34|<|0.0001|TWO_SIDED|95.0|-2.11|-0.773||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the step-down testing procedure (continued only if previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c (\<8.0, ≥8.0%), randomization strata of screening BMI (\<30 kg/m\^2, ≥30 kg/m\^2), and country as fixed effects and baseline body weight value as covariates.||-0.773|-2.110|<0.0001
70967861|NCT01476475|141441611|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.24|STANDARD_ERROR_OF_MEAN|1.704||0.0583|TWO_SIDED|95.0|-6.592|0.114||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the step-down testing procedure (continued only if previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c (\<8.0, ≥8.0%), randomization strata of screening BMI (\<30 kg/m\^2, ≥30 kg/m\^2), and country as fixed effects.||0.114|-6.592|0.0583
70967862|NCT01278745|141441620|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019|||||||ANCOVA|Adjusted for baseline PAV||||||0.0019
70967863|NCT01265615|141441640|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70967864|NCT01265615|141441641|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70967865|NCT01265615|141441642|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70967866|NCT01265615|141441643|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70967867|NCT01265615|141441644|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70967868|NCT01265615|141441645|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70967869|NCT01265615|141441646|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70967870|NCT01265615|141441647|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70967871|NCT01265615|141441648|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70967872|NCT01265615|141441649|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
70967873|NCT01843842|141441664|SUPERIORITY|||||||0.016|||||||Global Test Statistic|See O'Brien 1984, Pocock 1997.||||||0.016
70967874|NCT01843842|141441665|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
70967875|NCT01843842|141441666|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
70967876|NCT01843842|141441667|SUPERIORITY|||||||0.0283||||||p-value is not adjusted for multiple comparisons|Kruskal-Wallis|||Fever (Day 3, doctor's examination)||||0.0283
70967877|NCT01843842|141441667|SUPERIORITY|||||||0.3264|||||||Kruskal-Wallis|||Non-specific (Day 3, doctor's examination)||||0.3264
70967878|NCT01843842|141441667|SUPERIORITY|||||||0.706|||||||Kruskal-Wallis|||Nasal/Throat/Chest (Day 3, doctor's examination)||||0.7060
70967879|NCT01843842|141441667|SUPERIORITY|||||||0.25|||||||Kruskal-Wallis|||All symptoms (Day 3, doctor's examination)||||0.25
70967880|NCT01843842|141441667|SUPERIORITY|||||||0.244|||||||ANCOVA|||Severity of clinical manifestations of acute respiratory infection (ARI) by Total Symptom Score on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)||||0.244
70967881|NCT01843842|141441668|SUPERIORITY|||||||0.1158|||||||Kruskal-Wallis|||Duration of fever based on Patient Diary Data||||0.1158
70967882|NCT01843842|141441668|SUPERIORITY|||||||0.5755|||||||Kruskal-Wallis|||Duration of non-specific symptoms based on Patient Diary Data||||0.5755
70967883|NCT01843842|141441668|SUPERIORITY|||||||0.4331|||||||Kruskal-Wallis|||Duration of nasal/ throat/ chest symptoms based on Patient Diary Data||||0.4331
70967884|NCT01843842|141441668|SUPERIORITY|||||||0.356|||||||Kruskal-Wallis|||Duration of all acute respiratory infection symptoms (fever, non-specific symptoms and nasal/ throat/ chest symptoms) based on Patient Diary Data||||0.3560
70967885|NCT01843842|141441669|SUPERIORITY|||||||0.0166||||||p-value is not adjusted for multiple comparisons|Kruskal-Wallis|||Fever (Days 1, 3, 6 doctor's examination)||||0.0166
70967886|NCT01843842|141441669|SUPERIORITY|||||||0.082|||||||Kruskal-Wallis|||Non-specific (Days 1, 3, 6 doctor's examination)||||0.0820
70967887|NCT01843842|141441669|SUPERIORITY|||||||0.7227|||||||Kruskal-Wallis|||Nasal/Throat/Chest (Days 1, 3, 6 doctor's examination)||||0.7227
70967888|NCT01843842|141441669|SUPERIORITY|||||||0.2645|||||||Kruskal-Wallis|||All symptoms (Days 1, 3, 6 doctor's examination)||||0.2645
70967889|NCT01843842|141441669|SUPERIORITY|||||||0.0142||||||p-value is not adjusted for multiple comparisons|Kruskal-Wallis|||Fever (Days 1-5, patient diary data)||||0.0142
70967890|NCT01843842|141441669|SUPERIORITY|||||||0.0145||||||p-value is not adjusted for multiple comparisons|Kruskal-Wallis|||Non-specific (Days 1-5, patient diary data)||||0.0145
70967891|NCT01843842|141441669|SUPERIORITY|||||||0.2963|||||||Kruskal-Wallis|||Nasal/Throat/Chest (Days 1-5, patient diary data)||||0.2963
70967892|NCT01843842|141441669|SUPERIORITY|||||||0.0364||||||p-value is not adjusted for multiple comparisons|Kruskal-Wallis|||All symptoms (Days 1-5, patient diary data)||||0.0364
70967893|NCT01843842|141441670|SUPERIORITY|||||||0.4|||||||ANCOVA|||||||0.40
70967894|NCT02953340|141441672|NON_INFERIORITY|The study used non inferiority margin of 0.62 days for the above comparison. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% confidence interval (CI) of the difference in mean DSN between the treatment arms was \<0.62 days.|Mean difference|-0.074|||<|0.0001|TWO_SIDED|95.0|-0.292|0.129|||t-statistics|The p-values are based on the calculated t-statistics from the bootstrapped sample mean and standard deviation.||||0.129|-0.292|< 0.0001
70967895|NCT01376778|141441682|SUPERIORITY||Risk Ratio (RR)|1.17||||0.42|TWO_SIDED|95.0|0.8|1.72|||Chi-squared|||||1.72|0.80|0.42
70967896|NCT01376778|141441687|SUPERIORITY||Risk Ratio (RR)|1.61|||||TWO_SIDED|95.0|0.86|3.03||||||||3.03|0.86|
70967897|NCT01376778|141441688|SUPERIORITY||Risk Ratio (RR)|2.82|||||TWO_SIDED|95.0|0.29|72.42||||||||72.42|0.29|
70967898|NCT01376778|141441689|SUPERIORITY||Risk Difference (RD)|-0.41|||||TWO_SIDED|||||||||||||
70967899|NCT01376778|141441690|SUPERIORITY||Risk Ratio (RR)|1.47|||||TWO_SIDED|95.0|0.81|2.67||||||||2.67|0.81|
70967900|NCT01376778|141441691|SUPERIORITY||Risk Ratio (RR)|1.61|||||TWO_SIDED|95.0|0.65|4.01||||||||4.01|0.65|
70967901|NCT01376778|141441693|SUPERIORITY||Risk Ratio (RR)|1.88|||||TWO_SIDED|95.0|0.66|5.41||||||||5.41|0.66|
70967902|NCT01376778|141441694|SUPERIORITY||Risk Difference (RD)|-0.25|||||TWO_SIDED|95.0|-0.66|0.15||||||||0.15|-0.66|
70967903|NCT01376778|141441695|SUPERIORITY||Risk Difference (RD)|-35.0|||||TWO_SIDED|95.0|-157.0|87.0||||||||87|-157|
70967904|NCT01376778|141441696|SUPERIORITY||Risk Ratio (RR)|1.92|||||TWO_SIDED|95.0|0.92|3.99||||||||3.99|0.92|
70967905|NCT01376778|141441700|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.03|31.5||||||||31.5|0.03|
70967906|NCT01376778|141441701|SUPERIORITY||Risk Ratio (RR)|0.48|||||TWO_SIDED|95.0|0.17|1.38||||||||1.38|0.17|
70967907|NCT01376778|141441704|SUPERIORITY||Risk Ratio (RR)|0.63|||||TWO_SIDED|95.0|0.32|1.23||||||||1.23|0.32|
70967908|NCT01376778|141441705|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.42|1.68||||||||1.68|0.42|
70967909|NCT01376778|141441706|SUPERIORITY||Risk Ratio (RR)|0.47|||||TWO_SIDED|95.0|0.17|5.23||||||||5.23|0.17|
70967910|NCT01376778|141441714|SUPERIORITY||Risk Ratio (RR)|1.3||||0.37|TWO_SIDED|95.0|0.7|2.5|||Chi-squared|||||2.5|0.7|0.37
70967911|NCT01376778|141441715|SUPERIORITY|||||||0.26|||||||Chi-squared|||||||0.26
70967912|NCT01376778|141441716|SUPERIORITY|||||||0.84|||||||Chi-squared|||||||0.84
70967913|NCT02375724|141441766|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.02||||0.0306|TWO_SIDED|95.0|-1.94|-0.1|||Mixed Models Analysis|Baseline and age as covariates; treatment group, sex, visit, smoking-status and treatment group-by-visit interaction as fixed effect factors||||-0.10|-1.94|0.0306
70967914|NCT02375724|141441767|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.22||||0.0793|TWO_SIDED|95.0|-0.46|0.03|||Mixed Models Analysis|Baseline and age as covariates; treatment group, sex, visit, smoking-status and treatment group-by-visit interaction as fixed effect factors||||0.03|-0.46|0.0793
70967915|NCT02375724|141441768|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.06||||0.844|TWO_SIDED|95.0|-0.64|0.52|||Mixed Models Analysis|Baseline and age as covariates; treatment group, sex, visit, smoking-status and treatment group-by-visit interaction as fixed effect factors||||0.52|-0.64|0.844
70967916|NCT01309659|141441810|SUPERIORITY_OR_OTHER|||||||0.308|TWO_SIDED|||||Correlation between ferritin and change in hemoglobin in the immediate intervention group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.308
70967917|NCT01309659|141441810|SUPERIORITY_OR_OTHER|||||||0.601|TWO_SIDED|||||Correlation between ferritin and change in hemoglobin in the waitlist group. Testing the correlation = 0.|t-test, 2 sided|||||||0.601
70967918|NCT01309659|141441810|SUPERIORITY_OR_OTHER|||||||0.396|TWO_SIDED|||||Correlation between iron and change in hemoglobin in the intermediate intervention group. Testing the correlation = 0.|t-test, 2 sided|||||||0.396
70967919|NCT01309659|141441810|SUPERIORITY_OR_OTHER|||||||0.106|TWO_SIDED|||||Correlation between iron and change in hemoglobin in the waitlist group. Testing the correlation = 0.|t-test, 2 sided|||||||0.106
70967920|NCT01309659|141441810|SUPERIORITY_OR_OTHER|||||||0.606|TWO_SIDED|||||Correlation between transferrin saturation and change in hemoglobin in the immediate intervention group. Testing the correlation = 0.|t-test, 2 sided|||||||0.606
70967921|NCT01309659|141441810|SUPERIORITY_OR_OTHER|||||||0.077|TWO_SIDED|||||Correlation between transferrin saturation and change in hemoglobin in the waitlist group. Testing the correlation = 0.|t-test, 2 sided|||||||0.077
70967922|NCT01309659|141441819|SUPERIORITY_OR_OTHER|||||||0.649|TWO_SIDED|||||Correlation between soluble transfer receptor and change in hemoglobin in the immediate intervention group. Testing the correlation =0.|t-test, 2 sided|||||||0.649
70967923|NCT01309659|141441819|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Correlation between soluble transfer receptor and change in hemoglobin in the wait list group. Testing the correlation =0.|t-test, 2 sided|||||||0.001
70967924|NCT01309659|141441820|SUPERIORITY_OR_OTHER|||||||0.391|TWO_SIDED|||||Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in hemoglobin in the immediate intervention group. Testing correlation =0.|t-test, 2 sided|||||||0.391
70967925|NCT01309659|141441820|SUPERIORITY_OR_OTHER|||||||0.111|TWO_SIDED|||||Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in hemoglobin in the wait list control group. Testing correlation =0.|t-test, 2 sided|||||||0.111
70967926|NCT01309659|141441821|SUPERIORITY_OR_OTHER|||||||0.077|TWO_SIDED|||||Correlation between baseline serum ferritin and the change in 6 Minute Walk Test distance in the immediate intervention group. Testing correlation =0.|t-test, 2 sided|||||||0.077
70967927|NCT01309659|141441821|SUPERIORITY_OR_OTHER|||||||0.798|TWO_SIDED|||||Correlation between baseline serum ferritin and the change in 6 Minute Walk Test distance in the wait list group. Testing correlation =0.|t-test, 2 sided|||||||0.798
70967928|NCT01309659|141441821|SUPERIORITY_OR_OTHER|||||||0.383|TWO_SIDED|||||Correlation between baseline iron and the change in 6 Minute Walk Test distance in the immediate intervention group. Testing correlation =0.|t-test, 2 sided|||||||0.383
70967929|NCT01309659|141441821|SUPERIORITY_OR_OTHER|||||||0.732|TWO_SIDED|||||Correlation between baseline iron and the change in 6 Minute Walk Test distance in the wait list group. Testing correlation =0.|t-test, 2 sided|||||||0.732
70967930|NCT01309659|141441821|SUPERIORITY_OR_OTHER|||||||0.286|TWO_SIDED|||||Correlation between baseline transferrin saturation and the change in 6 Minute Walk Test distance in the immediate intervention group. Testing correlation =0.|t-test, 2 sided|||||||0.286
70967931|NCT01309659|141441821|SUPERIORITY_OR_OTHER|||||||0.356|TWO_SIDED|||||Correlation between baseline transferrin saturation and the change in 6 Minute Walk Test distance in the wait list group. Testing correlation =0.|t-test, 2 sided|||||||0.356
70967932|NCT01309659|141441822|SUPERIORITY_OR_OTHER|||||||0.649|TWO_SIDED|||||Correlation between baseline soluble transferrin receptor and the change in the 6 Meter Walk Test distance of the immediate intervention group. Testing correlation =0.|t-test, 2 sided|||||||0.649
70967933|NCT01309659|141441822|SUPERIORITY_OR_OTHER|||||||0.396|TWO_SIDED|||||Correlation between baseline soluble transferrin receptor and the change in the 6 Meter Walk Test distance of the wait list group. Testing correlation =0.|t-test, 2 sided|||||||0.396
70967934|NCT01309659|141441823|SUPERIORITY_OR_OTHER|||||||0.624|TWO_SIDED|||||Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in the 6 Minute Walk Test Distance in the intermediate intervention group. Testing correlation =0.|t-test, 2 sided|||||||0.624
70967935|NCT01309659|141441823|SUPERIORITY_OR_OTHER|||||||0.329|TWO_SIDED|||||Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in the 6 Minute Walk Test Distance in the wait list group. Testing correlation =0.|t-test, 2 sided|||||||0.329
70967936|NCT02285777|141441830|OTHER|Pre-specified.|Vaccine Effectiveness|71.0||||0.0001|TWO_SIDED|95.0|69.0|73.0|||Generalized Linear Model|To obtain the VE measure which is a measure based on RR, BINOMIAL DISTRIBUTION \& LOG LINK options were used to compute log10 RR \& corresponding CI.||The Vaccine Effectiveness (VE) at 1 month after the 3-dose vaccination series for each strain is defined as \[1 - (percentage of subjects without bactericidal activity at 1:4 dilution in MenABCWY group/percentage of subjects without bactericidal activity at 1:4 dilution in MenACWY group)\] x 100.The combined VE across all strains was computed by mean of a generalized linear model.||73|69|0.0001
70967937|NCT02285777|141441831|OTHER|Pre-specified.|Vaccine Effectiveness|51.0||||0.0001|TWO_SIDED|95.0|48.0|55.0|||Generalized Linear Model|To obtain the VE measure which is a measure based on RR, BINOMIAL DISTRIBUTION \& LOG LINK options were used to compute log10 RR \& corresponding CI.||The Vaccine Effectiveness (VE) at 4 months after the 3-dose vaccination series for each strain is defined as \[1 - (percentage of subjects without bactericidal activity at 1:4 dilution in MenABCWY group/percentage of subjects without bactericidal activity at 1:4 dilution in MenACWY group)\] x 100. The combined VE across all strains was computed by mean of a generalized linear model.||55|48|0.0001
70967938|NCT02285777|141441832|OTHER|Pre-specified.|Vaccine Effectiveness|51.0||||0.0001|TWO_SIDED|95.0|48.0|54.0|||Generalized Linear Model|To obtain the VE measure which is a measure based on RR, BINOMIAL DISTRIBUTION \& LOG LINK options were used to compute log10 RR \& corresponding CI.||The Vaccine Effectiveness (VE) at 1 month after the 3-dose vaccination series for each strain is defined as \[1 - (percentage of subjects without bactericidal activity at 1:8 dilution in MenABCWY group/percentage of subjects without bactericidal activity at 1:8 dilution in MenACWY group)\] x 100. The combined VE across all strains was computed by mean of a generalized linear model.||54|48|0.0001
70967939|NCT02285777|141441832|OTHER|Pre-specified.|Vaccine Effectiveness|24.0||||0.0001||95.0|20.0|28.0|||Generalized Linear Model|To obtain the VE measure which is a measure based on RR, BINOMIAL DISTRIBUTION \& LOG LINK options were used to compute log10 RR \& corresponding CI.||The Vaccine Effectiveness (VE) at 4 months after the 3-dose vaccination series for each strain is defined as \[1 - (percentage of subjects without bactericidal activity at 1:8 dilution in MenABCWY group/percentage of subjects without bactericidal activity at 1:8 dilution in MenACWY group)\] x 100. The combined VE across all strains was computed by mean of a generalized linear model.||28|20|0.0001
70967940|NCT00271596|141441869|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.166|STANDARD_ERROR_OF_MEAN|0.098||0.092|TWO_SIDED|95.0|-0.361|0.028|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.028|-0.361|0.092
70967941|NCT00271596|141441870|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.337|STANDARD_ERROR_OF_MEAN|0.168||0.048|TWO_SIDED|95.0|-0.672|-0.003|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||-0.003|-0.672|0.048
70967942|NCT00271596|141441871|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.278|STANDARD_ERROR_OF_MEAN|0.268||0.302|TWO_SIDED|95.0|-0.81|0.254|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic)||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.254|-0.810|0.302
70967943|NCT00271596|141441872|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.057|STANDARD_ERROR_OF_MEAN|0.153||0.708|TWO_SIDED|95.0|-0.361|0.246|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.246|-0.361|0.708
70967944|NCT00271596|141441873|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.069|STANDARD_ERROR_OF_MEAN|0.15||0.646|TWO_SIDED|95.0|-0.229|0.367|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.367|-0.229|0.646
70967945|NCT00271596|141441874|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.174||0.23||95.0|-0.554|0.135|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.135|-0.554|0.230
70967946|NCT00271596|141441875|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.317|STANDARD_ERROR_OF_MEAN|0.482||0.512|TWO_SIDED|95.0|-1.276|0.642|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.642|-1.276|0.512
70967947|NCT00271596|141441876|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9|STANDARD_ERROR_OF_MEAN|1.17||0.12|TWO_SIDED|95.0|-4.3|0.5|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.50|-4.30|0.12
70967948|NCT00271596|141441877|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|0.68||0.49|TWO_SIDED|95.0|-1.87|0.91|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.91|-1.87|0.49
70967949|NCT00271596|141441878|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|-2.5|STANDARD_ERROR_OF_MEAN|1.23||0.05|TWO_SIDED|95.0|-5.04|0.04||Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).|Mixed Models Analysis|||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.04|-5.04|0.05
70967950|NCT04206605|141441891|SUPERIORITY||Rate Ratio|1.02|||=|0.899|TWO_SIDED|95.0|0.71|1.47||P-value was from Wald-based chi-square test; unadjusted for multiple testing.|Chi-squared|||||1.47|0.71|=0.899
70967951|NCT04206605|141441892|SUPERIORITY||Risk Difference (RD)|0.003|||=|1|TWO_SIDED|95.0|-0.153|0.114||P-value was from the corresponding Mantel-Haenszel estimate for the common risk difference from Cochran-Mantel-Haenszel (CMH) test; unadjusted for multiple testing.|Cochran-Mantel-Haenszel|||||0.114|-0.153|=1.000
70967952|NCT04206605|141441893|SUPERIORITY||Rate Ratio|0.96|||=|0.852|TWO_SIDED|95.0|0.62|1.48||P-value was from Wald-based chi-square test; unadjusted for multiple testing.|Chi-squared|||||1.48|0.62|=0.852
70967953|NCT04206605|141441894|SUPERIORITY||Rate Ratio|1.1|||=|0.66|TWO_SIDED|95.0|0.72|1.7||P-value was from Wald-based chi-square test; unadjusted for multiple testing.|Chi-squared|||||1.70|0.72|=0.660
70967954|NCT04206605|141441895|SUPERIORITY||Risk Difference (RD)|-0.087|||=|0.25|TWO_SIDED|95.0|-0.28|0.063||P-value was from the corresponding Mantel-Haenszel estimate for the common risk difference from CMH test; unadjusted for multiple testing.|Cochran-Mantel-Haenszel|||||0.063|-0.280|=0.250
70967955|NCT04206605|141441897|SUPERIORITY||Rate Ratio|0.97|||=|0.896|TWO_SIDED|95.0|0.58|1.61||P-value was from Wald-based chi-square test; unadjusted for multiple testing.|Chi-squared|||||1.61|0.58|=0.896
70967956|NCT04206605|141441899|SUPERIORITY||||||=|0.498||||||P-value comparing lanadelumab to placebo was from a log rank test stratified by baseline strata.|Log Rank|||||||=0.498
70967957|NCT04206605|141441900|SUPERIORITY||||||=|0.184||||||P-value comparing lanadelumab to placebo was from a log rank test stratified by baseline strata.|Log Rank|||||||=0.184
70967958|NCT03437564|141441957|EQUIVALENCE|The difference in the least square (LS) means between the formulations (dosing of one Vortioxetine 20 mg tablet - dosing of two Vortioxetine 10 mg tablets) and the two-sided 90% confidence interval (CI) were provided using a crossover analysis of variance (ANOVA) model. The shown data were anti-logs of LS means difference and CI. The ANOVA model included log-transformed (natural log) PK parameters AUClast as dependent variable, and treatment condition, group, and period as independent variables.|Point Estimate|0.996|||||TWO_SIDED|90.0|0.967|1.026|||ANOVA|||||1.026|0.967|
70967959|NCT03437564|141441958|EQUIVALENCE|The difference in the LS means between the formulations (dosing of one vortioxetine 20 mg tablet - dosing of two vortioxetine 10 mg tablets) and the two-sided 90% CI were provided using a crossover ANOVA model. The shown data were anti-logs of LS means difference and CI. The ANOVA model included log-transformed (natural log) PK parameters Cmax as dependent variable, and treatment condition, group, and period as independent variables.|Point Estimate|0.972|||||TWO_SIDED|90.0|0.937|1.008|||ANOVA|||||1.008|0.937|
70967960|NCT04037748|141441969|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric least squares (LS) mean ratio|90.8|||||TWO_SIDED|90.0|86.3|95.6||||||||95.6|86.3|
70967961|NCT04037748|141441970|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric least squares (LS) mean ratio|93.7|||||TWO_SIDED|90.0|88.2|99.5||||||||99.5|88.2|
70967962|NCT04037748|141441972|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric least squares (LS) mean ratio|97.3|||||TWO_SIDED|90.0|94.7|100.0||||||||100.0|94.7|
70967963|NCT04037748|141441973|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric least squares (LS) mean ratio|94.82|||||TWO_SIDED|90.0|92.0|97.8||||||||97.8|92.0|
70967964|NCT00942175|141441992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|||||TWO_SIDED|90.0|0.6106|0.8026|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.8026|0.6106|
70967965|NCT00942175|141441992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.734|||||TWO_SIDED|90.0|0.6516|0.8269|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.8269|0.6516|
70967966|NCT00942175|141441992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5564|||||TWO_SIDED|90.0|0.4877|0.6347|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.6347|0.4877|
70967967|NCT00942175|141441992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6783|||||TWO_SIDED|90.0|0.5063|0.9087|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.9087|0.5063|
70967968|NCT00942175|141441993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8573|||||TWO_SIDED|90.0|0.802|0.9165|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.9165|0.8020|
70967969|NCT00942175|141441993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9103|||||TWO_SIDED|90.0|0.8567|0.9672|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.9672|0.8567|
70967970|NCT00942175|141441993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6943|||||TWO_SIDED|90.0|0.6438|0.7487|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.7487|0.6438|
70967971|NCT00942175|141441993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8389|||||TWO_SIDED|90.0|0.644|1.0928|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||1.0928|0.6440|
70967972|NCT00942175|141441994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1016|||||TWO_SIDED|90.0|0.0348|8.1684|||||Included only participants with complete data for both regimens. Values are least squares mean difference.|||8.1684|0.0348|
70967973|NCT00942175|141441994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0474|||||TWO_SIDED|90.0|-0.8555|4.9503|||||Included only participants with complete data for both regimens. Values are least squares mean difference.|||4.9503|-0.8555|
70967974|NCT00942175|141441994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0407|||||TWO_SIDED|90.0|6.5219|15.5595|||||Included only participants with complete data for both regimens. Values are least squares mean difference.|||15.5595|6.5219|
70967975|NCT00942175|141441994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.4437|||||TWO_SIDED|90.0|7.1791|15.7083|||||Included only participants with complete data for both regimens. Values are least squares mean difference.|||15.7083|7.1791|
70967976|NCT00942175|141441995|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||0.035
70967977|NCT00942175|141441995|SUPERIORITY_OR_OTHER|||||||0.445||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||0.445
70967978|NCT00942175|141441995|SUPERIORITY_OR_OTHER||||||<|0.001||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||<0.001
70967979|NCT00942175|141441995|SUPERIORITY_OR_OTHER||||||<|0.001||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||<0.001
70967980|NCT00942175|141441996|SUPERIORITY_OR_OTHER|||||||0.004||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||0.004
70967981|NCT00942175|141441996|SUPERIORITY_OR_OTHER|||||||0.148||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||0.148
70967982|NCT00942175|141441996|SUPERIORITY_OR_OTHER||||||<|0.001||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||<0.001
70967983|NCT00942175|141441996|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||<.0001
70967984|NCT00545064|141442008|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.2|STANDARD_DEVIATION|20.2||0.001||95.0|-0.6|7.0|||t-test, 2 sided|||"The change is the post-baseline value minus the baseline value.~Null Hypothesis: change in GSS-SYMP-6 score = 7"||7.0|-0.6|0.001
70967985|NCT00545064|141442008|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.2|STANDARD_DEVIATION|20.2||0.097||95.0|-0.6|7.0|||t-test, 2 sided|||"The change is the post-baseline value minus the baseline value.~Null Hypothesis: change in GSS-SYMP-6 = 0"||7.0|-0.6|0.097
70967986|NCT00545064|141442011|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.5|STANDARD_DEVIATION|5.3|<|0.001||95.0|-12.3|-10.7|||t-test, 2 sided|||"The change is the post-baseline value minus the baseline value.~Null Hypothesis: change in IOP = -4"||-10.7|-12.3|<0.001
70967987|NCT00545064|141442011|SUPERIORITY_OR_OTHER||Median Difference (Net)|-11.5|STANDARD_DEVIATION|5.3|<|0.001||95.0|-12.3|-10.7|||t-test, 2 sided|||"The change is the post-baseline value minus the baseline value.~Null Hypothesis: change in IOP = 0"||-10.7|-12.3|<0.001
70967988|NCT02321930|141442031|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Analysis performed to test for the change in values from Baseline to 3 months||||<0.0001
70967989|NCT02321930|141442032|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Analysis performed to test for the change in values from Baseline to 3 months||||<0.0001
70967990|NCT02321930|141442033|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Analysis performed to test for the change in values from Baseline to 3 months||||<0.0001
70967991|NCT02321930|141442034|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Analysis performed to test for the change in values from Baseline to 3 months||||<0.0001
70967992|NCT02321930|141442035|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Analysis performed to test for the change in values from Baseline to 3 months||||<0.0001
70967993|NCT00853749|141442038|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|2.7|||||TWO_SIDED|95.0|-5.0|14.2||||||Comparison between treatments for common serotype 4||14.2|-5.0|
70967994|NCT00853749|141442038|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for common serotype 6B||9.5|-7.3|
70967995|NCT00853749|141442038|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for common serotype 9V||9.5|-7.3|
70967996|NCT00853749|141442038|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.8|9.5||||||Comparison between treatments for common serotype 14||9.5|-7.8|
70967997|NCT00853749|141442038|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|2.7|||||TWO_SIDED|95.0|-5.0|14.2||||||Comparison between treatments for common serotype 18C||14.2|-5.0|
70967998|NCT00853749|141442038|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for common serotype 19F||9.5|-7.3|
70967999|NCT00853749|141442038|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for common serotype 23F||9.5|-7.3|
70968000|NCT00853749|141442038|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|2.7|||||TWO_SIDED|95.0|-5.0|14.2||||||Comparison between treatments for additional serotype 1||14.2|-5.0|
70968001|NCT00853749|141442038|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 3||9.5|-7.3|
70968002|NCT00853749|141442038|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 5||9.5|-7.3|
70968003|NCT00853749|141442038|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 6A||9.5|-7.3|
70968004|NCT00853749|141442038|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 7F||9.5|-7.3|
70968005|NCT00853749|141442038|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 19A||9.5|-7.3|
70968006|NCT00853749|141442039|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.8|||||TWO_SIDED|95.0|-8.6|12.7||||||Comparison between treatments for common serotype 4||12.7|-8.6|
70968007|NCT00853749|141442039|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.5|9.7||||||Comparison between treatments for common serotype 6B||9.7|-7.5|
70968008|NCT00853749|141442039|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.5|9.7||||||Comparison between treatments for common serotype 9V||9.7|-7.5|
70968009|NCT00853749|141442039|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.5|9.7||||||Comparison between treatments for common serotype 14||9.7|-7.5|
70968010|NCT00853749|141442039|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.4|10.0||||||Comparison between treatments for common serotype 18C||10.0|-7.4|
70968011|NCT00853749|141442039|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.5|10.0||||||Comparison between treatments for common serotype 19F||10.0|-7.5|
70968012|NCT00853749|141442039|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|-2.0|||||TWO_SIDED|95.0|-10.8|8.1||||||Comparison between treatments for common serotype 23F||8.1|-10.8|
70968013|NCT00853749|141442039|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|2.7|||||TWO_SIDED|95.0|-5.0|14.2||||||Comparison between treatments for additional serotype 1||14.2|-5.0|
70968014|NCT00853749|141442039|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|-2.0|||||TWO_SIDED|95.0|-11.1|7.9||||||Comparison between treatments for additional serotype 3||7.9|-11.1|
70968015|NCT00853749|141442039|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.7|||||TWO_SIDED|95.0|-8.5|12.2||||||Comparison between treatments for additional serotype 5||12.2|-8.5|
70968016|NCT00853749|141442039|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 6A||9.5|-7.3|
70968017|NCT00853749|141442039|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|-2.0|||||TWO_SIDED|95.0|-11.3|7.7||||||Comparison between treatments for additional serotype 7F||7.7|-11.3|
70968018|NCT00853749|141442039|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 19A||9.5|-7.3|
70968019|NCT00853749|141442040|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.3|||||TWO_SIDED|95.0|0.22|0.42|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 1: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.42|0.22|
70968020|NCT00853749|141442040|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.32|||||TWO_SIDED|95.0|0.23|0.44|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ((PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 5: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.44|0.23|
70968021|NCT00853749|141442040|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.44|||||TWO_SIDED|95.0|0.29|0.67|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 6B: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.67|0.29|
70968022|NCT00853749|141442040|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.88|||||TWO_SIDED|95.0|0.61|1.27|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 19F: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.27|0.61|
70968023|NCT00853749|141442040|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.47|||||TWO_SIDED|95.0|0.34|0.65|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 23F: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.65|0.34|
70968024|NCT00853749|141442041|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.6|||||TWO_SIDED|95.0|0.35|1.12|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 4: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.12|0.35|
70968025|NCT00853749|141442041|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.68|1.38|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 6B: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.38|0.68|
70968026|NCT00853749|141442041|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.51|1.81|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 9V: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.81|0.51|
70968027|NCT00853749|141442041|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.67|1.48|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 14: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.48|0.67|
70968028|NCT00853749|141442041|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.6|||||TWO_SIDED|95.0|0.33|0.98|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures(PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 18C: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.98|0.33|
70968029|NCT00853749|141442041|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|1.1|||||TWO_SIDED|95.0|0.72|1.56|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 19F: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.56|0.72|
70968030|NCT00853749|141442041|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.6|||||TWO_SIDED|95.0|0.39|0.99|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 23F: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.99|0.39|
70968031|NCT00853749|141442041|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.2|||||TWO_SIDED|95.0|0.12|0.32|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 1: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.32|0.12|
70968032|NCT00853749|141442041|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.8|||||TWO_SIDED|95.0|0.56|1.18|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 3: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.18|0.56|
70968033|NCT00853749|141442041|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.4|||||TWO_SIDED|95.0|0.21|0.63|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 5: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.63|0.21|
70968034|NCT00853749|141442041|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|1.4|||||TWO_SIDED|95.0|0.88|2.25|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 6A: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||2.25|0.88|
70968035|NCT00853749|141442041|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.7|||||TWO_SIDED|95.0|0.48|1.14|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 7F: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.14|0.48|
70968036|NCT00853749|141442041|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.8|||||TWO_SIDED|95.0|0.54|1.2|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 19A: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.20|0.54|
70968037|NCT00853749|141442042|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.37|||||TWO_SIDED|95.0|0.25|0.55|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 4: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.55|0.25|
70968038|NCT00853749|141442042|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.71|||||TWO_SIDED|95.0|0.44|1.15|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 6B: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.15|0.44|
70968039|NCT00853749|141442042|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.58|||||TWO_SIDED|95.0|0.45|0.75|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 9V: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.75|0.45|
70968040|NCT00853749|141442042|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.77|||||TWO_SIDED|95.0|0.48|1.24|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 14: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.24|0.48|
70968041|NCT00853749|141442042|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.57|||||TWO_SIDED|95.0|0.38|0.85|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 18C: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.85|0.38|
70968042|NCT00853749|141442042|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.84|||||TWO_SIDED|95.0|0.56|1.27|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 19F: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.27|0.56|
70968043|NCT00853749|141442042|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.64|||||TWO_SIDED|95.0|0.44|0.95|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 23F: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.95|0.44|
70968044|NCT00853749|141442042|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.27|||||TWO_SIDED|95.0|0.18|0.4|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 1: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.40|0.18|
70968045|NCT00853749|141442042|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|1.14|||||TWO_SIDED|95.0|0.76|1.72|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 3: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.72|0.76|
70968046|NCT00853749|141442042|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.36|||||TWO_SIDED|95.0|0.25|0.51|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 5: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.51|0.25|
70968047|NCT00853749|141442042|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.79|||||TWO_SIDED|95.0|0.55|1.14|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 6A: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.14|0.55|
70968048|NCT00853749|141442042|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.89|||||TWO_SIDED|95.0|0.61|1.28|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 7F: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.28|0.61|
70968049|NCT00853749|141442042|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.86|||||TWO_SIDED|95.0|0.6|1.23|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 19A: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.23|0.60|
70968050|NCT00853749|141442043|SUPERIORITY_OR_OTHER_LEGACY|||||||0.253|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for any tenderness||||0.253
70968051|NCT00853749|141442043|SUPERIORITY_OR_OTHER_LEGACY|||||||0.38|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for significant tenderness||||0.380
70968052|NCT00853749|141442043|SUPERIORITY_OR_OTHER_LEGACY|||||||0.135|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for any redness||||0.135
70968053|NCT00853749|141442043|SUPERIORITY_OR_OTHER_LEGACY|||||||0.52|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for mild redness||||0.520
70968054|NCT00853749|141442043|SUPERIORITY_OR_OTHER_LEGACY|||||||0.283|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for moderate redness||||0.283
70968055|NCT00853749|141442043|SUPERIORITY_OR_OTHER_LEGACY|||||||0.225|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for severe redness||||0.225
70968056|NCT00853749|141442043|SUPERIORITY_OR_OTHER_LEGACY|||||||0.202|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for any swelling||||0.202
70968057|NCT00853749|141442043|SUPERIORITY_OR_OTHER_LEGACY|||||||0.294|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for mild swelling||||0.294
70968058|NCT00853749|141442043|SUPERIORITY_OR_OTHER_LEGACY|||||||0.175|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for moderate swelling||||0.175
70968059|NCT00853749|141442043|SUPERIORITY_OR_OTHER_LEGACY|||||||0.314|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for severe swelling||||0.314
70968060|NCT00853749|141442044|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for fever ≥ 38 degrees C but ≤ 39 degrees C||||> .99
70968061|NCT00853749|141442044|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for decreased appetite||||> .99
70968062|NCT00853749|141442044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.543|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for irritability||||0.543
70968063|NCT00853749|141442044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.233|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for increased sleep||||0.233
70968064|NCT00853749|141442044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.198|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for decreased sleep||||0.198
70968065|NCT00853749|141442044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.628|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for rash||||0.628
70968066|NCT01392677|141442045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.1022|<|0.0001|TWO_SIDED|95.0|-0.89|-0.49||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|Mixed Models Analysis|Longitudinal repeated measures model using mixed model with treatment group, baseline value, week and week\*treatment and week\*baseline||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.49|-0.89|<0.0001
70968067|NCT01392677|141442046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.45|STANDARD_ERROR_OF_MEAN|4.8846|<|0.0001|TWO_SIDED|95.0|-43.08|-23.82||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|ANCOVA|with treatment group as effect and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-23.82|-43.08|<0.0001
70968068|NCT01392677|141442047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.07|STANDARD_ERROR_OF_MEAN|0.3651|<|0.0001|TWO_SIDED|95.0|-2.79|-1.35||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|ANCOVA|with treatment group as effect and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.35|-2.79|<0.0001
70968069|NCT01392677|141442048|SUPERIORITY_OR_OTHER||Risk Difference (RD)|20.7|STANDARD_ERROR_OF_MEAN|5.056|<|0.0001|TWO_SIDED|95.0|10.7|30.6||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Tsiatis, Davidian, Zhang \& Lu, with adjustment for baseline value||H0: proportion(treat) minus proportion (placebo) = 0 versus the alternative HA: proportion (treat) minus proportion (placebo) =/= 0||30.6|10.7|<0.0001
70968070|NCT01392677|141442049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.76|STANDARD_ERROR_OF_MEAN|1.6677||0.025|TWO_SIDED|95.0|-7.05|-0.48||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|ANCOVA|with treatment group as effect and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.48|-7.05|0.025
70968071|NCT00736255|141442050|SUPERIORITY_OR_OTHER|||||||0.54|||||||Chi-squared|||"Null Hypothesis:LDX and NRT will not facilitate smoking cessation compared to NRT and placebo.~Alternate Hypothesis: LDX and NRT will facilitate smoking cessation compared to NRT and placebo.~This is a one tailed, proof of concept study so there is no formal power analysis, however if we see a signal for treatment effect, we would like to do further investigation by conducting a separate trial."||||0.54
70968072|NCT04036708|141442097|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|2.33||0.77|TWO_SIDED|95.0|-3.93|5.32||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Planned sample size of total 100 analyzed was determined by feasibility considerations for this exploratory developmental R21 study. With planned n=66 in MISC+WTM arm and n=34 in WTM only arm, the unadjusted effect size of 0.60 was detectable as statistically significant with power of 0.80 and 0.05 level of significance in two-tailed tests.||5.32|-3.93|.77
70968073|NCT04036708|141442097|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|2.44||0.9|TWO_SIDED|95.0|-5.14|4.54||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Planned sample size of total 100 analyzed was determined by feasibility considerations for this exploratory developmental R21 study. With planned n=66 in MISC+WTM arm and n=34 in WTM only arm, the unadjusted effect size of 0.60 was detectable as statistically significant with power of 0.80 and 0.05 level of significance in two-tailed tests.||4.54|-5.14|.90
70968074|NCT04036708|141442098|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|64.03|STANDARD_ERROR_OF_MEAN|24.55||0.01|TWO_SIDED|95.0|15.26|112.8||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, the HOME score, child's age and sex were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Planned sample size of total 100 analyzed was determined by feasibility considerations for this exploratory developmental R21 study. With planned n=66 in MISC+WTM arm and n=34 in WTM only arm, the unadjusted effect size of 0.60 was detectable as statistically significant with power of 0.80 and 0.05 level of significance in two-tailed tests.||112.8|15.26|.01
70968075|NCT04036708|141442098|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|-37.53|STANDARD_ERROR_OF_MEAN|24.86||0.13|TWO_SIDED|95.0|-86.92|11.85||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, the HOME score, and child's age and sex were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Planned sample size of total 100 analyzed was determined by feasibility considerations for this exploratory developmental R21 study. With planned n=66 in MISC+WTM arm and n=34 in WTM only arm, the unadjusted effect size of 0.60 was detectable as statistically significant with power of 0.80 and 0.05 level of significance in two-tailed tests.||11.85|-86.92|.13
70968076|NCT04036708|141442099|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|-1.76|STANDARD_ERROR_OF_MEAN|2.97||0.55|TWO_SIDED|95.0|-7.65|4.13||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome and household material possessions were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||4.13|-7.65|.55
70968077|NCT04036708|141442099|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|-3.42|STANDARD_ERROR_OF_MEAN|3.05||0.26|TWO_SIDED|95.0|-9.48|2.63||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome and household material possessions were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||2.63|-9.48|.26
70968078|NCT04036708|141442100|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.16||0.32|TWO_SIDED|95.0|-0.48|0.16||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||0.16|-0.48|.32
70968079|NCT04036708|141442100|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.16||0.02|TWO_SIDED|95.0|-0.72|-0.06||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||-0.06|-0.72|.02
70968080|NCT04036708|141442101|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.2||0.06|TWO_SIDED|95.0|-0.78|0.01||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||0.01|-0.78|.06
70968081|NCT04036708|141442101|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.21||0.001|TWO_SIDED|95.0|-1.11|-0.28||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||-0.28|-1.11|.001
70968082|NCT04036708|141442102|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|1.05|STANDARD_ERROR_OF_MEAN|0.49||0.04|TWO_SIDED|95.0|0.07|2.03||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||2.03|0.07|.04
70968083|NCT04036708|141442102|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|0.94|STANDARD_ERROR_OF_MEAN|0.51||0.07|TWO_SIDED|95.0|-0.08|1.96||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||1.96|-0.08|.07
70968084|NCT04036708|141442103|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|2.04|STANDARD_ERROR_OF_MEAN|0.51|<|0.01|TWO_SIDED|95.0|1.02|3.06||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||3.06|1.02|<.01
70968085|NCT04036708|141442103|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|1.73|STANDARD_ERROR_OF_MEAN|0.53|<|0.01|TWO_SIDED|95.0|0.67|2.79||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||2.79|0.67|<.01
70968086|NCT02535715|141442130|SUPERIORITY|ANOVA Bonferroni adjustment|||||<|0.05|||||||ANOVA|||||||<0.05
70968087|NCT02933034|141442132|OTHER|||||||0.001|||||||t-test, 2 sided|||Comparison of infarct size using MEMRI versus DEMRI scan||||0.001
70968088|NCT01648790|141442174|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.983|||||TWO_SIDED|90.0|0.819|1.18|||||Least Squares (LS) means were determined by mixed-effect linear models with treatment, period, sequence as fixed effects, and participants nested within sequence as random effect.|||1.18|0.819|
70968089|NCT01648790|141442175|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.987|||||TWO_SIDED|90.0|0.918|1.06|||||LS means were determined by mixed-effect linear models with treatment, period, sequence as fixed effects, and participants nested within sequence as random effect.|||1.06|0.918|
70968090|NCT01648790|141442176|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.28|||||TWO_SIDED|90.0|0.233|0.335|||||LS means were determined by mixed-effect linear models with treatment, period, sequence as fixed effects, and participants nested within sequence as random effect.|||0.335|0.233|
70968091|NCT01648790|141442177|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.779|||||TWO_SIDED|90.0|0.724|0.837|||||LS means were determined by mixed-effect linear models with treatment, period, sequence as fixed effects, and participants nested within sequence as random effect.|||0.837|0.724|
70968092|NCT01977599|141442201|OTHER|Chi Square|||||<|0.001|||||||Chi-squared|||||||<0.001
70968093|NCT02684604|141442205|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
70968094|NCT01197521|141442208|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.15|||<|0.001|TWO_SIDED|95.0|0.08|0.22||Week 24|Mantel Haenszel|Treatment difference in proportion of responders with a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.22|0.08|<0.001
70968095|NCT01197521|141442208|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.1||||0.006|TWO_SIDED|95.0|0.03|0.18||Week 24|Mantel Haenszel|Treatment difference in proportion of responders with a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.18|0.03|0.006
70968096|NCT01197521|141442209|SUPERIORITY_OR_OTHER|||||||0.252||||||Week 24|Cochran-Mantel-Haenszel|The residuals from the ANCOVA are analysed using a Cochran-Mantel-Haenszel approach, adjusting for the effects of pooled country.||This analysis is performed using an ANCOVA model on the ranks of the change from baseline, by pooled country, including a term for the ranks of the baseline score as a covariate.||||0.252
70968097|NCT01197521|141442209|SUPERIORITY_OR_OTHER|||||||0.17||||||Week 24|Cochran-Mantel-Haenszel|The residuals from the ANCOVA are analysed using a Cochran-Mantel-Haenszel approach, adjusting for the effects of pooled country.||This analysis is performed using an ANCOVA model on the ranks of the change from baseline, by pooled country, including a term for the ranks of the baseline score as a covariate.||||0.170
70968098|NCT01197521|141442210|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.13|||<|0.001|TWO_SIDED|95.0|0.1|0.17||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.17|0.10|<0.001
70968099|NCT01197521|141442211|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.16|||<|0.001|TWO_SIDED|95.0|0.11|0.22||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.22|0.11|<0.001
70968100|NCT01197521|141442211|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.09||||0.002|TWO_SIDED|95.0|0.03|0.14||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.14|0.03|0.002
70968101|NCT01197521|141442212|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.08|||<|0.001|TWO_SIDED|95.0|0.05|0.12||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.12|0.05|<0.001
70968102|NCT01197521|141442212|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.04||||0.015|TWO_SIDED|95.0|0.01|0.07||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.07|0.01|0.015
70968103|NCT01197521|141442213|SUPERIORITY_OR_OTHER||||||<|0.001||||||Nominal p-value presented for treatment comparison. ACRn was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|Van Elteren|The treatment differences, 95% CIs and p-values are estimated using the Van Elteren test stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||||<0.001
70968104|NCT01197521|141442213|SUPERIORITY_OR_OTHER|||||||0.002||||||Nominal p-value presented for treatment comparison. ACRn was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|Van Elteren|The treatment differences, 95% CIs and p-values are estimated using the Van Elteren test stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||||0.002
70968105|NCT01197521|141442214|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.0|||<|0.001|TWO_SIDED|95.0|2.44|14.64||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||14.64|2.44|<0.001
70968106|NCT01197521|141442214|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4||||0.002|TWO_SIDED|95.0|1.76|11.02||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||11.02|1.76|0.002
70968107|NCT01197521|141442215|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.0|||<|0.001|TWO_SIDED|95.0|1.63|5.67||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||5.67|1.63|<0.001
70968108|NCT01197521|141442215|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.083|TWO_SIDED|95.0|0.93|3.5||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.50|0.93|0.083
70968109|NCT01197521|141442216|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.43|||<|0.001|TWO_SIDED|95.0|1.79|3.3||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.30|1.79|<0.001
70968110|NCT01197521|141442216|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57||||0.004|TWO_SIDED|95.0|1.16|2.14||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.14|1.16|0.004
70968111|NCT01197521|141442217|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.68|3.26||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.26|1.68|<0.001
70968112|NCT01197521|141442217|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9|||<|0.001|TWO_SIDED|95.0|1.38|2.68||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.68|1.38|<0.001
70968113|NCT01197521|141442218|SUPERIORITY_OR_OTHER||Treatment difference|2.24|||<|0.001||95.0|1.16|3.31||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.31|1.16|<0.001
70968114|NCT01197521|141442218|SUPERIORITY_OR_OTHER||Treatment difference|1.27||||0.02||95.0|0.2|2.35||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.35|0.20|0.020
70968115|NCT01197521|141442219|SUPERIORITY_OR_OTHER||Treatment difference|1.8||||0.005||95.0|0.54|3.07||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.07|0.54|0.005
70968116|NCT01197521|141442219|SUPERIORITY_OR_OTHER||Treatment difference|1.56||||0.017||95.0|0.28|2.83||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.83|0.28|0.017
70968117|NCT00258674|141442236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.307||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.307
70968118|NCT00258674|141442237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.551||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.551
70968119|NCT00258674|141442238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.927||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.927
70968120|NCT00258674|141442239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.308||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.308
70968121|NCT00258674|141442240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.867||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.867
70968122|NCT00258674|141442241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98||||0.807||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.807
70968123|NCT00258674|141442242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.702||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.702
70968124|NCT00258674|141442243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.413||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.413
70968125|NCT00258674|141442244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.996||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.996
70968126|NCT00258674|141442245|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.02||||0.451||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.451
70968127|NCT00258674|141442246|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.1||||0.447||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.447
70968128|NCT00258674|141442247|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.01||||0.936||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.936
70968129|NCT00258674|141442248|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.04||||0.332||95.0||||A comparison of the claims vs. claims+MR arms was also conducted, giving a p-value of 0.537.|Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.332
70968130|NCT00258674|141442249|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.01||||0.86||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.860
70968131|NCT00258674|141442250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.382||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.382
70968132|NCT00258674|141442251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.988||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.988
70968133|NCT00258674|141442252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.685||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.685
70968134|NCT03715153|141442253|SUPERIORITY||Estimate of the adjusted difference|0.35|STANDARD_ERROR_OF_MEAN|0.71||0.617|TWO_SIDED|95.0|-1.04|1.75|||t-test, 2 sided|General Linear Model including the fixed, categorical effects of treatment, country, gender, as well as the continuous, fixed covariates of baseline.|Estimate of the adjusted difference was based on 211 patients (Missing data were imputed).|||1.75|-1.04|0.617
70968135|NCT03715153|141442254|SUPERIORITY||Estimate of the adjusted difference|0.48|STANDARD_ERROR_OF_MEAN|3.26|||TWO_SIDED|95.0|-5.91|6.88|||||General Linear Model including the fixed, categorical effects of treatment, country, gender, as well as the continuous, fixed covariates of baseline. Estimate of the adjusted difference was based on 211 patients (Missing data were imputed).|||6.88|-5.91|
70968136|NCT03715153|141442255|SUPERIORITY||Estimate of the adjusted difference|-0.04|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.24|0.16|||||Rank-based analysis (Wilcoxon scores) including terms for fixed categorical effects of treatment, country and gender. Estimate of the adjusted difference was based on 211 patients (Missing data were imputed).|||0.16|-0.24|
70968137|NCT03715153|141442256|SUPERIORITY||Estimate of the adjusted difference|0.16|STANDARD_ERROR_OF_MEAN|0.81|||TWO_SIDED|95.0|-1.42|1.75|||||General Linear Model including the fixed, categorical effects of treatment, country, gender, as well as the continuous, fixed covariates of baseline. Estimate of the adjusted difference was based on 211 patients (Missing data were imputed).|||1.75|-1.42|
70968138|NCT03715153|141442260|SUPERIORITY||Estimate of the adjusted difference|-0.26|STANDARD_ERROR_OF_MEAN|2.48|||TWO_SIDED|95.0|-5.12|4.59||||||||4.59|-5.12|
70968139|NCT01412554|141442265|OTHER|Only descriptive statistics|||||<|0.05|||||||Spearman|The degree of tracking was assessed by Spearman's rank or Pearson's correlation coefficient||Only an observational follow-up study|The degree of tracking was assessed by Spearman's rank or Pearson's correlation coefficient|||<0.05
70968140|NCT00078325|141442273|SUPERIORITY_OR_OTHER|||||||0.0001|||||||ANOVA|Treatment and country as factors.||||||0.0001
70968141|NCT00078325|141442273|SUPERIORITY_OR_OTHER|||||||0.0008|||||||ANOVA|Treatment and country as factors.||||||0.0008
70968142|NCT00078325|141442274|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Adjusted for country.||||||<0.0001
70968143|NCT00078325|141442274|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Adjusted for country.||||||<0.0001
70968144|NCT00578136|141442275|SUPERIORITY_OR_OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|The Wilcoxon rank-sum test was used because the study did not have a normal distribution using the Kolmogorov-Smirnov test (p\<0.01).||Assuming the opioid requirement in the local infiltration group to be 0.2mg kg-1 and in the rectus sheath block group to be 0.1mg kg-1, a sample size of 44 patients (22 in each group) will have a power of 80% to detect a difference in means of 0.1mg kg-1 with a 0.005 two-sided significance level.||||0.008
70968145|NCT03710486|141442289|SUPERIORITY||Odds Ratio (OR)|0.61|||=|0.13202|TWO_SIDED|95.0|0.32|1.16|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by propensity scores inverse probability treatment weighting (PS-IPTW).|Estimated with a logistic regression adjusted by PS-IPTW.|||1.16|0.32|=0.13202
70968146|NCT03710486|141442290|SUPERIORITY||Odds Ratio (OR)|1.18|||=|0.5861|TWO_SIDED|95.0|0.65|2.13|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||2.13|0.65|=0.5861
70968147|NCT03710486|141442293|SUPERIORITY||Odds Ratio (OR)|0.65|||=|0.1648|TWO_SIDED|95.0|0.35|1.19|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||1.19|0.35|=0.1648
70968148|NCT03710486|141442294|SUPERIORITY||Odds Ratio (OR)|0.66|||=|0.1732|TWO_SIDED|95.0|0.36|1.2|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||1.20|0.36|=0.1732
70968149|NCT03710486|141442297|SUPERIORITY||||||=|0.2011|||||||Log Rank Test Adjusted by PS-IPTW|p-value was estimated with Log Rank test adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.||CD: Vedolizumab Versus Other Biological||||=0.2011
70968150|NCT03710486|141442298|SUPERIORITY||||||=|0.6939|||||||Log Rank Test Adjusted by PS-IPTW|p-value was estimated with Log Rank test adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.||||||=0.6939
70968151|NCT03710486|141442299|SUPERIORITY||Odds Ratio (OR)|0.29|||=|0.0071|TWO_SIDED|95.0|0.12|0.71|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.71|0.12|=0.0071
70968152|NCT03710486|141442300|SUPERIORITY||Odds Ratio (OR)|1.28|||=|0.4809|TWO_SIDED|95.0|0.64|2.55|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||2.55|0.64|=0.4809
70968153|NCT03710486|141442301|SUPERIORITY||Odds Ratio (OR)|1.05|||=|0.915|TWO_SIDED|95.0|0.46|2.36|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||2.36|0.46|=0.9150
70968154|NCT03710486|141442302|SUPERIORITY||Odds Ratio (OR)|1.13|||=|0.7254|TWO_SIDED|95.0|0.56|2.28|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||2.28|0.56|=0.7254
70968155|NCT03710486|141442303|SUPERIORITY||Odds Ratio (OR)|0.34|||=|0.0051|TWO_SIDED|95.0|0.16|0.72|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.72|0.16|=0.0051
70968156|NCT03710486|141442304|SUPERIORITY||Odds Ratio (OR)|0.53|||=|0.0653|TWO_SIDED|95.0|0.27|1.04|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||1.04|0.27|=0.0653
70968157|NCT03710486|141442305|SUPERIORITY||Odds Ratio (OR)|0.9|||=|0.7629|TWO_SIDED|95.0|0.47|1.74|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||1.74|0.47|=0.7629
70968158|NCT03710486|141442306|SUPERIORITY||Odds Ratio (OR)|0.8|||=|0.4895|TWO_SIDED|95.0|0.43|1.5|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||1.50|0.43|=0.4895
70968159|NCT03710486|141442307|SUPERIORITY||Odds Ratio (OR)|0.76|||=|0.4458|TWO_SIDED|95.0|0.38|1.54|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||1.54|0.38|=0.4458
70968160|NCT03710486|141442308|SUPERIORITY||Odds Ratio (OR)|0.98|||=|0.9471|TWO_SIDED|95.0|0.47|2.04|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||2.04|0.47|=0.9471
70968161|NCT03710486|141442309|SUPERIORITY||Odds Ratio (OR)|0.42|||=|0.0104|TWO_SIDED|95.0|0.21|0.81|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.81|0.21|=0.0104
70968162|NCT03710486|141442310|SUPERIORITY||Odds Ratio (OR)|0.26|||=|0.0011|TWO_SIDED|95.0|0.12|0.59|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.59|0.12|=0.0011
70968163|NCT03710486|141442311|SUPERIORITY||Odds Ratio (OR)|0.98|||=|0.9471|TWO_SIDED|95.0|0.47|2.04|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|CD Participants||2.04|0.47|=0.9471
70968164|NCT03710486|141442312|SUPERIORITY||Odds Ratio (OR)|0.3|||=|0.0104|TWO_SIDED|95.0|0.12|0.75|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.75|0.12|=0.0104
70968165|NCT03710486|141442313|SUPERIORITY||Odds Ratio (OR)|0.26|||=|0.0011|TWO_SIDED|95.0|0.12|0.59|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.59|0.12|=0.0011
70968166|NCT03710486|141442314|SUPERIORITY||Odds Ratio (OR)|1.28|||=|0.54|TWO_SIDED|95.0|0.59|2.78|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||2.78|0.59|=0.5400
70968167|NCT03710486|141442315|SUPERIORITY||Odds Ratio (OR)|1.21|||=|0.8123|TWO_SIDED|95.0|0.26|5.66|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||5.66|0.26|=0.8123
70968168|NCT03710486|141442316|SUPERIORITY||Odds Ratio (OR)|0.22|||=|0.0282|TWO_SIDED|95.0|0.06|0.85|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.85|0.06|=0.0282
70968169|NCT03710486|141442317|SUPERIORITY||Odds Ratio (OR)|1.13|||=|0.8584|TWO_SIDED|95.0|0.29|4.36|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||4.36|0.29|=0.8584
70968170|NCT03710486|141442318|SUPERIORITY||Odds Ratio (OR)|0.95|||=|0.9474|TWO_SIDED|95.0|0.24|3.78|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||3.78|0.24|=0.9474
70968171|NCT03710486|141442319|SUPERIORITY||Odds Ratio (OR)|0.73|||=|0.3103|TWO_SIDED|95.0|0.4|1.34|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse event||1.34|0.40|=0.3103
70968172|NCT03710486|141442319|SUPERIORITY||Odds Ratio (OR)|0.41|||=|0.0045|TWO_SIDED|95.0|0.22|0.76|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse event||0.76|0.22|=0.0045
70968173|NCT03710486|141442319|SUPERIORITY||Odds Ratio (OR)|1.19|||=|0.6287|TWO_SIDED|95.0|0.59|2.42|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse event||2.42|0.59|=0.6287
70968174|NCT03710486|141442319|SUPERIORITY||Odds Ratio (OR)|0.65|||=|0.2495|TWO_SIDED|95.0|0.31|1.36|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse event||1.36|0.31|=0.2495
70968175|NCT03710486|141442320|SUPERIORITY||Risk Ratio (RR)|0.89|||=|0.4784|TWO_SIDED|95.0|0.66|1.22|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse event||1.22|0.66|=0.4784
70968176|NCT03710486|141442320|SUPERIORITY||Risk Ratio (RR)|0.83|||=|0.2616|TWO_SIDED|95.0|0.6|1.15|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse event||1.15|0.60|=0.2616
70968177|NCT03710486|141442320|SUPERIORITY||Risk Ratio (RR)|2.01|||=|0.0077|TWO_SIDED|95.0|1.2|3.34|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse event||3.34|1.20|=0.0077
70968178|NCT03710486|141442320|SUPERIORITY||Risk Ratio (RR)|1.3|||=|0.3046|TWO_SIDED|95.0|0.79|2.14|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse event||2.14|0.79|=0.3046
70968179|NCT03710486|141442321|SUPERIORITY||Odds Ratio (OR)|0.54|||=|0.1681|TWO_SIDED|95.0|0.22|1.3|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse events related to treatment||1.30|0.22|=0.1681
70968180|NCT03710486|141442321|SUPERIORITY||Odds Ratio (OR)|0.23|||=|0.0645|TWO_SIDED|95.0|0.05|1.09|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse events related to treatment||1.09|0.05|=0.0645
70968181|NCT03710486|141442321|SUPERIORITY||Odds Ratio (OR)|0.38|||=|0.3145|TWO_SIDED|95.0|0.06|2.51|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse events related to treatment||2.51|0.06|=0.3145
70968182|NCT03710486|141442321|SUPERIORITY||Odds Ratio (OR)|1.49|||=|0.8197|TWO_SIDED|95.0|0.05|47.11|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse events related to treatment||47.11|0.05|=0.8197
70968183|NCT03710486|141442322|SUPERIORITY||Risk Ratio (RR)|0.43|||=|0.0239|TWO_SIDED|95.0|0.2|0.89|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse events related to treatment||0.89|0.20|=0.0239
70968184|NCT03710486|141442322|SUPERIORITY||Risk Ratio (RR)|0.21|||=|0.0373|TWO_SIDED|95.0|0.05|0.91|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse events related to treatment||0.91|0.05|=0.0373
70968185|NCT03710486|141442322|SUPERIORITY||Risk Ratio (RR)|0.54|||=|0.426|TWO_SIDED|95.0|0.12|2.49|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse events related to treatment||2.49|0.12|=0.4260
70968186|NCT03710486|141442322|SUPERIORITY||Risk Ratio (RR)|1.56|||=|0.8012|TWO_SIDED|95.0|0.05|48.44|||Poisson Regression||The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse events related to treatment||48.44|0.05|=0.8012
70968187|NCT03710486|141442323|SUPERIORITY||Odds Ratio (OR)|0.17|||=|0.0044|TWO_SIDED|95.0|0.05|0.58|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|||0.58|0.05|=0.0044
70968188|NCT03710486|141442323|SUPERIORITY||Odds Ratio (OR)|0.32|||=|0.0215|TWO_SIDED|95.0|0.12|0.84|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|||0.84|0.12|=0.0215
70968189|NCT03710486|141442324|SUPERIORITY||Risk Ratio (RR)|0.27|||=|0.0152|TWO_SIDED|95.0|0.1|0.78|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|||0.78|0.10|=0.0152
70968190|NCT03710486|141442324|SUPERIORITY||Risk Ratio (RR)|1.56|||=|0.8012|TWO_SIDED|95.0|0.05|48.44|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|||48.44|0.05|=0.8012
70968191|NCT03302975|141442342|SUPERIORITY|||||||0.001|TWO_SIDED|95.0|||||ANOVA|||||||0.001
70968192|NCT04722042|141442386|SUPERIORITY|||||||0.557|||||||ANOVA|||comparison of word recognition over time (activation, and 1, 3, 6, and 12 months post-activation) between groups (default versus place-based)||||0.557
70968193|NCT04722042|141442387|SUPERIORITY|||||||0.208|||||||ANOVA|||comparison of spatial release from masking over time (1, 3, 6, and 12 months post-activation) between the groups (default versus place-based)||||0.208
70968194|NCT04722042|141442388|SUPERIORITY|||||||0.126|||||||ANOVA|||comparison of spatial release from masking between the groups over time||||0.126
70968195|NCT04722042|141442389|SUPERIORITY|||||||0.369|||||||ANOVA|||comparison of perceived benefit between the groups over time||||0.369
70968196|NCT04722042|141442390|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||0.006
70968197|NCT04722042|141442391|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
70968198|NCT04722042|141442392|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
70968199|NCT00255970|141442415|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||This study had been designed as a superiority study. The null hypothesis had been that there would be no significant difference in probing depth between groups at the time points measured.||||>.05
70968200|NCT00255970|141442415|SUPERIORITY_OR_OTHER||||||>|0.05||||||The power analysis had been computed for a threshold of 0.05 with a power of 0.8.|ANOVA|||A power analysis, prior to data collection, determined that a minimum of 18 in each arm would be needed for this study.||||>0.05
70968201|NCT00255970|141442416|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||This study had been designed as a superiority study. The a priori power analysis had been designed with an effect size based on historical data. Thus, a minimal sample size of 34 patients would be necessary to determine if there was a true difference between groups, α =.05, power= 0.8. This number was then rounded to 40 patients, 20/ group (DFDBA and Regenafil).||||>.05
70968202|NCT00255970|141442417|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||The change in recession, measured in mm, had been designed as a superiority study. The a priori power analysis had been designed with an effect size based on historical data. Thus, a minimal sample size of 34 patients would be necessary to determine if there was a true difference between groups, α =.05, power= 0.8. This number was then rounded to 40 patients, 20/ group (DFDBA and Regenafil).||||>0.05
70968203|NCT00255970|141442418|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||Each gingival unit (buccal, lingual, mesiobuccal, distobuccal, mesiolingual, and distolingual) of the individual tooth will be given a score from 0-3, called the gingival index for the area. The scores from the 6 areas of the tooth are added and divided by 6 to give the gingival index for the tooth.||||>0.05
70968204|NCT00255970|141442419|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||This study had been designed as a superiority study. The a priori power analysis had been designed with an effect size based on historical data. Thus, a minimal sample size of 34 patients would be necessary to determine if there was a true difference between groups, α =.05, power= 0.8. This number was then rounded to 40 patients, 20/ group (DFDBA and Regenafil).||||>0.05
70968205|NCT03996876|141442422|SUPERIORITY|Given the relatively small sample size, results of our inferential statistical tests should be interpreted with caution.|F Statistic|1.032||||0.322|TWO_SIDED|||||The a priori threshold for statistical significance was set at 0.05.|ANOVA|We conducted a two-way mixed ANOVA with intervention as the between-subjects and time as the within-subjects variable.|The F Statistic reported is for the interaction between Intervention and Time.|||||0.322
70968206|NCT02726971|141442425|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
70968207|NCT01538628|141442451|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Exact binomial test|testing the null hypothesis that the proportion for SpaceOAR is less than or equal to 0.70.||||||.0001
70968208|NCT04360551|141442475|SUPERIORITY|||||||0.244|||||||Wilcoxon (Mann-Whitney)|||||||0.244
70968209|NCT04360551|141442476|SUPERIORITY||||||>|0.5|||||||Kruskal-Wallis|||||||>0.5
70968210|NCT03901105|141442513|OTHER||Risk Ratio (RR)|1.36||||0.0313|TWO_SIDED|95.0|1.028|1.785||A priori threshold was two-sided 0.05.|log linear model|Adjusted for treatment arm (lanabecestat 20 mg, 50 mg, or placebo), baseline age, years of education (categorical), and baseline CDR-SB score.|τAD++ scans represent the numerator for risk, and τAD+/τAD- scans represent the denominator|Scan results were grouped into τAD++ vs. non-τAD++ (τAD+ and τAD-) for the analysis||1.785|1.028|0.0313
70968211|NCT03901105|141442514|OTHER||Risk Ratio (RR)|1.35||||0.0833|TWO_SIDED|95.0|0.962|1.886||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|log linear model|Adjusted for treatment arm (lanabecestat 20 mg, 50 mg, or placebo), baseline age, years of education (categorical), and baseline score.|τAD++ scans represent the numerator for risk, and τAD+/τAD- scans represent the denominator|Risk ratio for MMSE CMD. Scan results were grouped into τAD++ vs. non-τAD++ (τAD+ and τAD-) for the analysis||1.886|0.962|.0833
70968212|NCT03901105|141442514|OTHER||Risk Ratio (RR)|1.77||||0.0141|TWO_SIDED|95.0|1.122|2.796||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|log linear model|Adjusted for treatment arm (lanabecestat 20 mg, 50 mg, or placebo), baseline age, years of education (categorical), and baseline score.|τAD++ scans represent the numerator for risk, and τAD+/τAD- scans represent the denominator|Risk ratio for ADAS-Cog11 CMD. Scan results were grouped into τAD++ vs. non-τAD++ (τAD+ and τAD-) for the analysis||2.796|1.122|.0141
70968213|NCT03901105|141442514|OTHER||Risk Ratio (RR)|1.32||||0.0639|TWO_SIDED|95.0|0.984|1.776||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|log linear model|Adjusted for treatment arm (lanabecestat 20 mg, 50 mg, or placebo), baseline age, years of education (categorical), and baseline score.|τAD++ scans represent the numerator for risk, and τAD+/τAD- scans represent the denominator|Risk ratio for FAQ CMD. Scan results were grouped into τAD++ vs. non-τAD++ (τAD+ and τAD-) for the analysis||1.776|0.984|.0639
70968214|NCT03901105|141442514|OTHER||Risk Ratio (RR)|1.28||||0.2814|TWO_SIDED|95.0|0.815|2.02||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|log linear model|Adjusted for treatment arm (lanabecestat 20 mg, 50 mg, or placebo), baseline age, years of education (categorical), and baseline score.|τAD++ scans represent the numerator for risk, and τAD+/τAD- scans represent the denominator|Risk ratio for CDR Global CMD. Scan results were grouped into τAD++ vs. non-τAD++ (τAD+ and τAD-) for the analysis||2.020|0.815|.2814
70968215|NCT03901105|141442515|OTHER|||||||0.0305||||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Mixed Models Analysis|Adjusted for baseline clinical score, age, years of education (categorical), and treatment arm (lanabecestat - 20mg or 50mg - or placebo).||MMRM testing the difference between CDR-SB least squares mean changes of tAD++ and Non-tAD++ (tAD+ and tAD-). The unstructured covariance structure (UN) was used.||||.0305
70968216|NCT03901105|141442515|OTHER||||||<|0.0001||||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Mixed Models Analysis|Adjusted for baseline clinical score, age, years of education (categorical), and treatment arm (lanabecestat - 20mg or 50mg - or placebo).||MMRM testing the difference between MMSE least squares mean changes of tAD++ and Non-tAD++ (tAD+ and tAD-). The unstructured covariance structure (UN) was used.||||<0.0001
70968217|NCT03901105|141442515|OTHER|||||||0.0006||||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Mixed Models Analysis|Adjusted for baseline clinical score, age, years of education (categorical), and treatment arm (lanabecestat - 20mg or 50mg - or placebo).||MMRM testing the difference between ADAS-Cog11 least squares mean changes of tAD++ and Non-tAD++ (tAD+ and tAD-). The unstructured covariance structure (UN) was used.||||0.0006
70968218|NCT03901105|141442515|OTHER|||||||0.0097||||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Mixed Models Analysis|Adjusted for baseline clinical score, age, years of education (categorical), and treatment arm (lanabecestat - 20mg or 50mg - or placebo).||MMRM testing the difference between FAQ least squares mean changes of tAD++ and Non-tAD++ (tAD+ and tAD-). The unstructured covariance structure (UN) was used.||||0.0097
70968219|NCT02700412|141442527|OTHER|Single group.|||||<|0.0001||||||P-value reported above is the global test for change in seizure frequency over a 12-month period.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test with Bonferonni multiple comparison correction was used as a post-hoc analysis to indicate direction of change.||Null hypothesis is that there was no change in seizure frequency between any two assessment time points during this period of analysis. Alternative hypothesis is that there were two or more assessment time points for which change in seizure frequency was different from zero.|Generalized least squares statistical techniques were used for modeling longitudinal data after normality of seizure frequency outcome measures were achieved through log-transformations methods. The following baseline clinical variables were adjusted for: AEDs, AEDs tried, epileptic surgery, and gender. Reported results were geometric least squares mean and its associated 95% Confidence Interval. Percentage reduction in seizure frequency relative to baseline were obtained by subtracting from 1 and then multiplying by 100 at all post-baseline timepoints.|||<0.0001
70968220|NCT02700412|141442528|OTHER|Single group.|||||<|0.0001||||||P-value reported above is the global test for change in seizure severity scores over a 12-month period.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test with Bonferonni multiple comparison correction was used as a post-hoc analysis to indicate direction of change.||Null hypothesis is that there was no change in seizure severity scores between any two assessment time points during this period of analysis. Alternative hypothesis is that there were two or more assessment time points for which change in seizure severity scores was different from zero.|Generalized least squares statistical techniques were used for modeling longitudinal data after normality of seizure severity score outcome measures were achieved through log-transformations methods. The following baseline clinical variables were adjusted for: AEDs, AEDs tried, epileptic surgery, and gender. Reported results were geometric least squares mean and its associated 95% Confidence Interval. Percentage reduction in seizure severity relative to baseline were obtained by subtracting from 1 and then multiplying by 100 at all post-baseline timepoints.|||<0.0001
70968221|NCT04416555|141442529|SUPERIORITY|||||||0.391|||||||Mixed Models Analysis|||||||0.391
70968222|NCT04416555|141442530|SUPERIORITY|||||||0.608|||||||Regression, Linear|||||||0.608
70968223|NCT04416555|141442531|SUPERIORITY|||||||0.768|||||||Mixed Models Analysis|||||||0.768
70968224|NCT04416555|141442532|SUPERIORITY|||||||0.244|||||||Wilcoxon (Mann-Whitney)|||||||0.244
70968225|NCT04416555|141442533|SUPERIORITY|||||||0.191|||||||Wilcoxon (Mann-Whitney)|||||||0.191
70968226|NCT01118273|141442539|SUPERIORITY_OR_OTHER|||||||0.54|||||||ANCOVA|||||||0.54
70968227|NCT01118273|141442540|SUPERIORITY_OR_OTHER|||||||0.31|||||||ANCOVA|||||||0.31
70968228|NCT01118273|141442541|SUPERIORITY_OR_OTHER|||||||0.45|||||||Log Rank|||||||0.45
70968229|NCT01118273|141442542|SUPERIORITY_OR_OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
70968230|NCT01118273|141442543|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANCOVA|||||||0.05
70968231|NCT01118273|141442544|SUPERIORITY_OR_OTHER|||||||0.019|||||||ANCOVA|||||||0.019
70968232|NCT01118273|141442545|SUPERIORITY_OR_OTHER|||||||0.018|||||||ANCOVA|||||||0.018
70968233|NCT01118273|141442546|SUPERIORITY_OR_OTHER|||||||0.03|||||||Cochran-Mantel-Haenszel|||||||0.03
70968234|NCT01118273|141442547|SUPERIORITY_OR_OTHER|||||||0.76|||||||Cochran-Mantel-Haenszel|||||||0.76
70968235|NCT01118273|141442548|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANCOVA|||||||0.015
70968236|NCT01118273|141442549|SUPERIORITY_OR_OTHER|||||||0.04|||||||Cochran-Mantel-Haenszel|||||||0.04
70968237|NCT01118273|141442550|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANCOVA|||||||0.95
70968238|NCT01118273|141442551|SUPERIORITY_OR_OTHER|||||||0.05|||||||Cochran-Mantel-Haenszel|||||||0.05
70968239|NCT01118273|141442553|SUPERIORITY_OR_OTHER|||||||0.42|||||||ANCOVA|||||||0.42
70968240|NCT01118273|141442554|SUPERIORITY_OR_OTHER|||||||0.35|||||||ANCOVA|||||||0.35
70968241|NCT01118273|141442555|SUPERIORITY_OR_OTHER|||||||0.35|||||||ANCOVA|||||||0.35
70968242|NCT01118273|141442556|SUPERIORITY_OR_OTHER|||||||0.72|||||||ANCOVA|||||||0.72
70968243|NCT01118273|141442557|SUPERIORITY_OR_OTHER|||||||0.001|||||||Log Rank|||||||0.001
70968244|NCT01118273|141442559|SUPERIORITY_OR_OTHER|||||||0.35|||||||Cochran-Mantel-Haenszel|||||||0.35
70968245|NCT01118273|141442561|SUPERIORITY_OR_OTHER|||||||0.53|||||||ANCOVA|||||||0.53
70968246|NCT01118273|141442562|SUPERIORITY_OR_OTHER|||||||0.55|||||||ANCOVA|||||||0.55
70968247|NCT01118273|141442563|SUPERIORITY_OR_OTHER|||||||0.59|||||||ANCOVA|||||||0.59
70968248|NCT01118273|141442564|SUPERIORITY_OR_OTHER|||||||0.25|||||||ANCOVA|||||||0.25
70968249|NCT00552175|141442572|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.17|-0.56|||Mixed Models Analysis|Covariates: Baseline value of average pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|The primary objective and primary efficacy analysis for the study was the analysis between the combined duloxetine arms and placebo.||-0.56|-1.17|<0.0001
70968250|NCT00552175|141442574|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.96|||<|0.0001|TWO_SIDED|95.0|-1.27|-0.64||P-value for Worst Pain.|Mixed Models Analysis|Covariates: Baseline value of worst pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.64|-1.27|<0.0001
70968251|NCT00552175|141442574|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.83|||<|0.0001|TWO_SIDED|95.0|-1.15|-0.51||P-value for Night Pain.|Mixed Models Analysis|Covariates: Baseline value of night pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.51|-1.15|<0.0001
70968252|NCT00552175|141442575|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.87|||||TWO_SIDED|95.0|-1.26|-0.49|||Mixed Models Analysis|Covariates: Baseline value of worst pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Worst Pain analysis||-0.49|-1.26|
70968253|NCT00552175|141442575|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.05|||||TWO_SIDED|95.0|-1.43|-0.66|||Mixed Models Analysis|Covariates: Baseline value of worst pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Worst Pain analysis||-0.66|-1.43|
70968254|NCT00552175|141442575|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.78|||||TWO_SIDED|95.0|-1.17|-0.39|||Mixed Models Analysis|Covariates: Baseline value of night pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Night Pain analysis||-0.39|-1.17|
70968255|NCT00552175|141442575|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.89|||||TWO_SIDED|95.0|-1.28|-0.5|||Mixed Models Analysis|Covariates: Baseline value of night pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Night Pain analysis||-0.5|-1.28|
70968256|NCT00552175|141442576|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.65|||<|0.0001|TWO_SIDED|95.0|-0.85|-0.44|||Mixed Models Analysis|Covariates: Baseline value of average pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.44|-0.85|<0.0001
70968257|NCT00552175|141442577|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.65|||||TWO_SIDED|95.0|-0.9|-0.39|||Mixed Models Analysis|Covariates: Baseline value of average pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.39|-0.9|
70968258|NCT00552175|141442577|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.65|||||TWO_SIDED|95.0|-0.91|-0.4|||Mixed Models Analysis|Covariates: Baseline value of average pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.4|-0.91|
70968259|NCT00552175|141442578|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.34|-0.61||P-value for Worst Pain.|Mixed Models Analysis|Covariates: Baseline value of worst pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.61|-1.34|<0.0001
70968260|NCT00552175|141442578|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.85|||<|0.0001|TWO_SIDED|95.0|-1.21|-0.48||P-value for Least Pain.|Mixed Models Analysis|Covariates: Baseline value of least pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.48|-1.21|<0.0001
70968261|NCT00552175|141442578|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.33|-0.67||P-value for Average Pain.|Mixed Models Analysis|Covariates: Baseline value of average pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.67|-1.33|<0.0001
70968262|NCT00552175|141442578|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.29|-0.54||P-value for Pain Right Now.|Mixed Models Analysis|Covariates: Baseline value of pain right now score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.54|-1.29|<0.0001
70968263|NCT00552175|141442579|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.89|||||TWO_SIDED|95.0|-1.34|-0.44|||Mixed Models Analysis|Covariates: Baseline value of worst pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Worst Pain Score analysis||-0.44|-1.34|
70968264|NCT00552175|141442579|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.06|||||TWO_SIDED|95.0|-1.51|-0.62|||Mixed Models Analysis|Covariates: Baseline value of worst pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Worst Pain Score analysis||-0.62|-1.51|
70968265|NCT00552175|141442579|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.78|||||TWO_SIDED|95.0|-1.23|-0.33|||Mixed Models Analysis|Covariates: Baseline value of least pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Least Pain Score analysis||-0.33|-1.23|
70968266|NCT00552175|141442579|SUPERIORITY_OR_OTHER||Least Mean Squares Difference|-0.91|||||TWO_SIDED|95.0|-1.36|-0.46|||Mixed Models Analysis|Covariates: Baseline value of least pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Least Pain Score analysis||-0.46|-1.36|
70968267|NCT00552175|141442579|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.98|||||TWO_SIDED|95.0|-1.39|-0.58|||Mixed Models Analysis|Covariates: Baseline value of average pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Average Pain Score analysis||-0.58|-1.39|
70968268|NCT00552175|141442579|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.01|||||TWO_SIDED|95.0|-1.41|-0.61|||Mixed Models Analysis|Covariates: Baseline value of average pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Average Pain Score analysis||-0.61|-1.41|
70968269|NCT00552175|141442579|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.88|||||TWO_SIDED|95.0|-1.35|-0.41|||Mixed Models Analysis|Covariates: Baseline value of pain right now score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Pain Right Now Score analysis||-0.41|-1.35|
70968270|NCT00552175|141442579|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.95|||||TWO_SIDED|95.0|-1.41|-0.48|||Mixed Models Analysis|Covariates: Baseline value of pain right now score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Pain Right Now Score analysis||-0.48|-1.41|
70968271|NCT00552175|141442580|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.41||||0.0676|TWO_SIDED|95.0|-0.85|0.03||P-value for General Activity.|Mixed Models Analysis|Covariates: Baseline value of general activity score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||0.03|-0.85|0.0676
70968272|NCT00552175|141442580|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.37||||0.0933|TWO_SIDED|95.0|-0.8|0.06||P-value for Mood.|Mixed Models Analysis|Covariates: Baseline value of mood score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||0.06|-0.8|0.0933
70968273|NCT00552175|141442580|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.49||||0.0228|TWO_SIDED|95.0|-0.91|-0.07||P-value for Walking Ability.|Mixed Models Analysis|Covariates: Baseline value of walking ability score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.07|-0.91|0.0228
70968274|NCT00552175|141442580|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.38||||0.0783|TWO_SIDED|95.0|-0.8|0.04||P-value for Normal Work.|Mixed Models Analysis|Covariates: Baseline value of normal work score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||0.04|-0.8|0.0783
70968275|NCT00552175|141442580|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.55||||0.0076|TWO_SIDED|95.0|-0.96|-0.15||P-value for Relation to People.|Mixed Models Analysis|Covariates: Baseline value of relation to people score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.15|-0.96|0.0076
70968276|NCT00552175|141442580|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.46||||0.0378|TWO_SIDED|95.0|-0.9|-0.03||P-value for Sleep.|Mixed Models Analysis|Covariates: Baseline value of sleep score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.03|-0.9|0.0378
70968277|NCT00552175|141442580|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.56||||0.0089|TWO_SIDED|95.0|-0.98|-0.14||P-value for Enjoyment of Life.|Mixed Models Analysis|Covariates: Baseline value of enjoyment of life score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.14|-0.98|0.0089
70968278|NCT00552175|141442580|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.48||||0.0095|TWO_SIDED|95.0|-0.85|-0.12||P-value for Average of Interference Scores|Mixed Models Analysis|Covariates: Baseline value of average of interference scores, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.12|-0.85|0.0095
70968279|NCT00552175|141442581|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.6|||||TWO_SIDED|95.0|-1.14|-0.06|||Mixed Models Analysis|Covariates: Baseline value of general activity, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|General Activity score analysis||-0.06|-1.14|
70968280|NCT00552175|141442581|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.23|||||TWO_SIDED|95.0|-0.77|0.32|||Mixed Models Analysis|Covariates: Baseline value of general activity, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|General Activity score analysis||0.32|-0.77|
70968281|NCT00552175|141442581|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.27|||||TWO_SIDED|95.0|-0.8|0.27|||Mixed Models Analysis|Covariates: Baseline value of mood score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Mood score analysis||0.27|-0.8|
70968282|NCT00552175|141442581|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.48|||||TWO_SIDED|95.0|-1.01|0.05|||Mixed Models Analysis|Covariates: Baseline value of mood score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Mood score analysis||0.05|-1.01|
70968283|NCT00552175|141442581|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.5|||||TWO_SIDED|95.0|-1.02|0.02|||Mixed Models Analysis|Covariates: Baseline value of walking ability, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Walking Ability score analysis||0.02|-1.02|
70968284|NCT00552175|141442581|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.49|||||TWO_SIDED|95.0|-1.01|0.03|||Mixed Models Analysis|Covariates: Baseline value of walking ability, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Walking Ability score analysis||0.03|-1.01|
70968285|NCT00552175|141442581|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.35|||||TWO_SIDED|95.0|-0.86|0.16|||Mixed Models Analysis|Covariates: Baseline value of normal work score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Normal Work score analysis||0.16|-0.86|
70968286|NCT00552175|141442581|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.41|||||TWO_SIDED|95.0|-0.92|0.11|||Mixed Models Analysis|Covariates: Baseline value of normal work score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Normal Work score analysis||0.11|-0.92|
70968287|NCT00552175|141442581|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.39|||||TWO_SIDED|95.0|-0.89|0.11|||Mixed Models Analysis|Covariates: Baseline value of relation to people, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Relation to People score analysis||0.11|-0.89|
70968288|NCT00552175|141442581|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.71|||||TWO_SIDED|95.0|-1.21|-0.22|||Mixed Models Analysis|Covariates: Baseline value of relation to people, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Relation to People score analysis||-0.22|-1.21|
70968289|NCT00552175|141442581|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.57|||||TWO_SIDED|95.0|-1.11|-0.03|||Mixed Models Analysis|Covariates: Baseline value of sleep score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Sleep score analysis||-0.03|-1.11|
70968290|NCT00552175|141442581|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.36|||||TWO_SIDED|95.0|-0.9|0.18|||Mixed Models Analysis|Covariates: Baseline value of sleep score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Sleep score analysis||0.18|-0.9|
70968291|NCT00552175|141442581|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.37|||||TWO_SIDED|95.0|-0.88|0.15|||Mixed Models Analysis|Covariates: Baseline value of enjoyment of life, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Enjoyment of Life score analysis||0.15|-0.88|
70968292|NCT00552175|141442581|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.76|||||TWO_SIDED|95.0|-1.27|-0.24|||Mixed Models Analysis|Covariates: Baseline value of enjoyment of life, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Enjoyment of Life score analysis||-0.24|-1.27|
70968293|NCT00552175|141442581|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.45|||||TWO_SIDED|95.0|-0.9|0.0|||Mixed Models Analysis|Covariates: Baseline value of average of interference scores, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Average of Interference scores analysis||0|-0.9|
70968294|NCT00552175|141442581|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.52|||||TWO_SIDED|95.0|-0.97|-0.07|||Mixed Models Analysis|Covariates: Baseline value of average of interference scores, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Average of Interference scores analysis||-0.07|-0.97|
70968295|NCT00552175|141442582|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.11||||0.8517|TWO_SIDED|95.0|-1.22|1.01|||Mixed Models Analysis|Covariates: Baseline value of BDI-II, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||1.01|-1.22|0.8517
70968296|NCT00552175|141442583|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.34|||||TWO_SIDED|95.0|-1.03|1.71|||Mixed Models Analysis|Covariates: Baseline value of BDI-II, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||1.71|-1.03|
70968297|NCT00552175|141442583|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.55|||||TWO_SIDED|95.0|-1.92|0.81|||Mixed Models Analysis|Covariates: Baseline value of BDI-II, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||0.81|-1.92|
70968298|NCT00884273|141442599|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority was to be established if the treatment difference in adjusted (for baseline volume, and baseline total IPSS) mean percentage reduction was significantly greater (two-sided at α=0.05 level) than Δ = 10 points (non-inferiority margin) in both the FAS and PP analyses sets.~If the Week 12 treatment assessment of prostate volume was missing the LOCF approach was used, i.e., the prostate volume value closest to and before Week 12 was used."|Mean Difference (Final Values)|2.37||||0.36|TWO_SIDED|95.0|-2.78|7.52||FAS.|ANCOVA|The baseline IPSS and baseline Prostate volume were used as covariates and treatment was used as a factor in the analysis.||Estimates from analysis of variance with treatment as factors and baseline IPSS and baseline Prostate volume as covariates.||7.52|-2.78|0.36
70968299|NCT00884273|141442608|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority was to be established if the treatment difference in adjusted (for baseline volume, and baseline total IPSS) mean percentage reduction was significantly greater (two-sided at α=0.05 level) than Δ = 10 points (non-inferiority margin) in both the FAS and PP analyses sets.~If the Week 12 treatment assessment of prostate volume was missing the LOCF approach was used, i.e., the prostate volume value closest to and before Week 12 was used."|Mean Difference (Net)|2.24||||0.41|TWO_SIDED|95.0|-3.1|7.58||PP.|ANCOVA|The baseline IPSS and baseline Prostate volume were used as covariates and treatment was used as a factor in the analysis.||Estimates from analysis of variance with treatment as factors and baseline IPSS and baseline Prostate volume as covariates.||7.58|-3.10|0.41
70968300|NCT01147744|141442620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.056||||0.326|TWO_SIDED|95.0|-0.06|0.17||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.||||0.17|-0.06|0.326
70968301|NCT01147744|141442620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.104||||0.066|TWO_SIDED|95.0|-0.01|0.22||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.||||0.22|-0.01|0.066
70968302|NCT01147744|141442620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.069||||0.224|TWO_SIDED|95.0|-0.04|0.18||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.||||0.18|-0.04|0.224
70968303|NCT01147744|141442620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.062||||0.271|TWO_SIDED|95.0|-0.05|0.17||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.||||0.17|-0.05|0.271
70968304|NCT01147744|141442620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.189|||<|0.001|TWO_SIDED|95.0|0.08|0.3||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.||||0.30|0.08|<0.001
70968305|NCT01147744|141442620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.22|TWO_SIDED|95.0|-0.04|0.18||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.||||0.18|-0.04|0.220
70968306|NCT01147744|141442621|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.385||||0.932|TWO_SIDED|95.0|-9.25|8.48|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||8.48|-9.25|0.932
70968307|NCT01147744|141442621|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.367||||0.762|TWO_SIDED|95.0|-7.5|10.23|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||10.23|-7.50|0.762
70968308|NCT01147744|141442621|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.798||||0.689|TWO_SIDED|95.0|-10.62|7.03|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||7.03|-10.62|0.689
70968309|NCT01147744|141442621|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.321||||0.605|TWO_SIDED|95.0|-6.49|11.13|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||11.13|-6.49|0.605
70968310|NCT01147744|141442621|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.46||||0.584|TWO_SIDED|95.0|-6.36|11.28|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||11.28|-6.36|0.584
70968311|NCT01147744|141442621|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.529||||0.907|TWO_SIDED|95.0|-8.4|9.45|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||9.45|-8.40|0.907
70968312|NCT01147744|141442622|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.463||||0.753|TWO_SIDED|95.0|-7.65|10.58|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||10.58|-7.65|0.753
70968313|NCT01147744|141442622|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.75||||0.419|TWO_SIDED|95.0|-5.36|12.87|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||12.87|-5.36|0.419
70968314|NCT01147744|141442622|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.046||||0.51|TWO_SIDED|95.0|-12.12|6.03|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||6.03|-12.12|0.510
70968315|NCT01147744|141442622|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.585||||0.32|TWO_SIDED|95.0|-4.47|13.64|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||13.64|-4.47|0.320
70968316|NCT01147744|141442622|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.484||||0.452|TWO_SIDED|95.0|-5.61|12.58|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||12.58|-5.61|0.452
70968317|NCT01147744|141442622|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.615||||0.229|TWO_SIDED|95.0|-3.55|14.78|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||14.78|-3.55|0.229
70968318|NCT01147744|141442623|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.169||||0.771|TWO_SIDED|95.0|-6.73|9.07|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||9.07|-6.73|0.771
70968319|NCT01147744|141442623|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.56||||0.257|TWO_SIDED|95.0|-3.33|12.45|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||12.45|-3.33|0.257
70968320|NCT01147744|141442623|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.326||||0.741|TWO_SIDED|95.0|-6.54|9.19|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||9.19|-6.54|0.741
70968321|NCT01147744|141442623|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.083||||0.983|TWO_SIDED|95.0|-7.76|7.93|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||7.93|-7.76|0.983
70968322|NCT01147744|141442623|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.204||||0.041|TWO_SIDED|95.0|0.34|16.07|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||16.07|0.34|0.041
70968323|NCT01147744|141442623|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.891||||0.475|TWO_SIDED|95.0|-5.05|10.83|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||10.83|-5.05|0.475
70968324|NCT01147744|141442624|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.837||||0.838|TWO_SIDED|95.0|-7.22|8.89|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||8.89|-7.22|0.838
70968325|NCT01147744|141442624|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.715||||0.508|TWO_SIDED|95.0|-5.33|10.76|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||10.76|-5.33|0.508
70968326|NCT01147744|141442624|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.124||||0.603|TWO_SIDED|95.0|-5.9|10.14|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||10.14|-5.90|0.603
70968327|NCT01147744|141442624|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|-1.781||||0.662|TWO_SIDED|95.0|-9.78|6.22|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||6.22|-9.78|0.662
70968328|NCT01147744|141442624|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.949||||0.146|TWO_SIDED|95.0|-2.08|13.98|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||13.98|-2.08|0.146
70968329|NCT01147744|141442624|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.394||||0.191|TWO_SIDED|95.0|-2.69|13.48|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||13.48|-2.69|0.191
70968330|NCT01147744|141442625|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.106||||0.164|TWO_SIDED|95.0|-2.5|14.71|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||14.71|-2.50|0.164
70968331|NCT01147744|141442625|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.106||||0.349||95.0|-4.49|12.7|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||12.70|-4.49|0.349
70968332|NCT01147744|141442625|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.148||||0.623|TWO_SIDED|95.0|-6.42|10.72|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||10.72|-6.42|0.623
70968333|NCT01147744|141442625|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.713||||0.694|TWO_SIDED|95.0|-6.84|10.26|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||10.26|-6.84|0.694
70968334|NCT01147744|141442625|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.592||||0.028|TWO_SIDED|95.0|1.03|18.15|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||18.15|1.03|0.028
70968335|NCT01147744|141442625|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.75||||0.125|TWO_SIDED|95.0|-1.89|15.38|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||15.38|-1.89|0.125
70968336|NCT01147744|141442626|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.346||||0.585|TWO_SIDED|95.0|-6.09|10.78|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||10.78|-6.09|0.585
70968337|NCT01147744|141442626|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.431||||0.92|TWO_SIDED|95.0|-8.0|8.86|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||8.86|-8.00|0.920
70968338|NCT01147744|141442626|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.702||||0.528|TWO_SIDED|95.0|-5.7|11.11|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||11.11|-5.70|0.528
70968339|NCT01147744|141442626|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.218||||0.776|TWO_SIDED|95.0|-9.6|7.17|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||7.17|-9.60|0.776
70968340|NCT01147744|141442626|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.49||||0.081|TWO_SIDED|95.0|-0.92|15.9|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||15.90|-0.92|0.081
70968341|NCT01147744|141442626|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.611||||0.403|TWO_SIDED|95.0|-4.87|12.09|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||12.09|-4.87|0.403
70968342|NCT01147744|141442627|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.005||||0.951|TWO_SIDED|95.0|-0.17|0.16|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.16|-0.17|0.951
70968343|NCT01147744|141442627|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.166||||0.043|TWO_SIDED|95.0|-0.33|-0.01|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||-0.01|-0.33|0.043
70968344|NCT01147744|141442627|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.028||||0.734|TWO_SIDED|95.0|-0.19|0.13|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.13|-0.19|0.734
70968345|NCT01147744|141442627|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.003||||0.972|TWO_SIDED|95.0|-0.16|0.16|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.16|-0.16|0.972
70968346|NCT01147744|141442627|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.097||||0.238|TWO_SIDED|95.0|-0.26|0.06|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.06|-0.26|0.238
70968347|NCT01147744|141442627|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.075||||0.36|TWO_SIDED|95.0|-0.24|0.09|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.09|-0.24|0.360
70968348|NCT01147744|141442628|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.028||||0.692|TWO_SIDED|95.0|-0.11|0.17|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.17|-0.11|0.692
70968349|NCT01147744|141442628|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.096||||0.176|TWO_SIDED|95.0|-0.24|0.04|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.04|-0.24|0.176
70968350|NCT01147744|141442628|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.021||||0.768|TWO_SIDED|95.0|-0.16|0.12|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.12|-0.16|0.768
70968351|NCT01147744|141442628|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.887|TWO_SIDED|95.0|-0.13|0.15|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.15|-0.13|0.887
70968352|NCT01147744|141442628|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.051||||0.471|TWO_SIDED|95.0|-0.19|0.09|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.09|-0.19|0.471
70968353|NCT01147744|141442628|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.083||||0.248|TWO_SIDED|95.0|-0.22|0.06|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.06|-0.22|0.248
70968354|NCT01147744|141442629|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.131||||0.209|TWO_SIDED|95.0|-0.33|0.07|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.07|-0.33|0.209
70968355|NCT01147744|141442629|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.264||||0.011|TWO_SIDED|95.0|-0.47|-0.06|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||-0.06|-0.47|0.011
70968356|NCT01147744|141442629|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.076||||0.464|TWO_SIDED|95.0|-0.28|0.13|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.13|-0.28|0.464
70968357|NCT01147744|141442629|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.045||||0.662|TWO_SIDED|95.0|-0.25|0.16|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.16|-0.25|0.662
70968358|NCT01147744|141442629|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.245||||0.018|TWO_SIDED|95.0|-0.45|-0.04|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||-0.04|-0.45|0.018
70968359|NCT01147744|141442629|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.207||||0.047|TWO_SIDED|95.0|-0.41|0.0|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||-0.00|-0.41|0.047
70968360|NCT01147744|141442630|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.098||||0.3|TWO_SIDED|95.0|-0.28|0.09|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.09|-0.28|0.300
70968361|NCT01147744|141442630|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.138||||0.145|TWO_SIDED|95.0|-0.32|0.05|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.05|-0.32|0.145
70968362|NCT01147744|141442630|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.123||||0.19|TWO_SIDED|95.0|-0.31|0.06|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.06|-0.31|0.190
70968363|NCT01147744|141442630|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.002||||0.98|TWO_SIDED|95.0|-0.19|0.18|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.18|-0.19|0.980
70968364|NCT01147744|141442630|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.171||||0.07|TWO_SIDED|95.0|-0.36|0.01|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.01|-0.36|0.070
70968365|NCT01147744|141442630|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.158||||0.095|TWO_SIDED|95.0|-0.34|0.03|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.03|-0.34|0.095
70968366|NCT01147744|141442631|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
70968367|NCT01147744|141442631|SUPERIORITY_OR_OTHER|||||||0.814|||||||Fisher Exact|||||||0.814
70968368|NCT01147744|141442631|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
70968369|NCT01147744|141442631|SUPERIORITY_OR_OTHER|||||||0.828|||||||Fisher Exact|||||||0.828
70968370|NCT01147744|141442631|SUPERIORITY_OR_OTHER|||||||0.477|||||||Fisher Exact|||||||0.477
70968371|NCT01147744|141442631|SUPERIORITY_OR_OTHER|||||||0.46|||||||Fisher Exact|||||||0.460
70968372|NCT00807742|141442653|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.606|TWO_SIDED|95.0|0.57|2.63|||Chi-squared|||||2.63|0.57|.606
70968373|NCT00807742|141442654|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.29|TWO_SIDED|95.0|0.57|2.63|||Chi-squared|||||2.63|0.57|.290
70968374|NCT00807742|141442655|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.03||||0.32|TWO_SIDED|95.0|0.49|8.23|||Chi-squared|||||8.23|0.49|.32
70968375|NCT00807742|141442656|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.08||||0.298|TWO_SIDED|95.0|0.51|8.45|||Chi-squared|||||8.45|0.51|.298
70968376|NCT00807742|141442657|SUPERIORITY||Effect Size d|-0.49|||<|0.001|TWO_SIDED|95.0|-0.71|-0.27|||t-test, 2 sided|||||-0.27|-0.71|<.001
70968377|NCT00807742|141442658|SUPERIORITY||Effect Size d|-0.15||||0.199|TWO_SIDED|95.0|-0.38|0.08|||t-test, 2 sided|||||0.08|-0.38|.199
70968378|NCT00807742|141442659|SUPERIORITY||Effect Size d|-0.12||||0.148|TWO_SIDED|95.0|-0.57|0.33|||t-test, 2 sided|||||0.33|-.57|.148
70968379|NCT00807742|141442660|SUPERIORITY||Effect Size d|-0.15||||0.249|TWO_SIDED|95.0|-0.4|0.11|||t-test, 2 sided|||||0.11|-0.40|.249
70968380|NCT00807742|141442661|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.402|TWO_SIDED|95.0|0.59|3.72|||Chi-squared|||||3.72|0.59|0.402
70968381|NCT00807742|141442662|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.772|TWO_SIDED|95.0|0.49|1.7|||Chi-squared|||||1.70|0.49|.772
70968382|NCT00807742|141442663|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.91|TWO_SIDED|95.0|0.6|1.77|||Chi-squared|||||1.77|0.60|.910
70968383|NCT00807742|141442664|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.812|TWO_SIDED|95.0|0.54|1.62|||Chi-squared|||||1.62|0.54|.812
70968384|NCT00807742|141442665|SUPERIORITY||Odds Ratio (OR)|0.76||||0.49|TWO_SIDED|95.0|0.36|1.65|||Chi-squared|||||1.65|0.36|.490
70968385|NCT00807742|141442666|SUPERIORITY||Odds Ratio (OR)|1.19||||0.511|TWO_SIDED|95.0|0.67|2.06|||Chi-squared|||||2.06|0.67|.511
70968386|NCT00807742|141442667|SUPERIORITY||Odds Ratio (OR)|1.19||||0.499|TWO_SIDED|95.0|0.72|1.97|||Chi-squared|||||1.97|0.72|.499
70968387|NCT00807742|141442668|SUPERIORITY||Odds Ratio (OR)|0.96||||0.876|TWO_SIDED|95.0|0.58|1.6|||Chi-squared|||||1.60|0.58|.876
70968388|NCT00807742|141442669|SUPERIORITY_OR_OTHER||Effect Size d|-0.37||||0.001|TWO_SIDED|95.0|-0.59|-0.15|||t-test, 2 sided|||||-0.15|-0.59|.001
70968389|NCT00807742|141442670|SUPERIORITY_OR_OTHER||Effect Size d|-0.25||||0.069|TWO_SIDED|95.0|-0.46|0.02|||t-test, 2 sided|||||0.02|-0.46|.069
70968390|NCT00807742|141442671|SUPERIORITY_OR_OTHER||Effect Size d|-0.16||||0.202|TWO_SIDED|95.0|-0.4|0.08|||t-test, 2 sided|||||0.08|-0.40|.202
70968391|NCT00807742|141442672|SUPERIORITY_OR_OTHER||Effect Size d|-0.17||||0.199|TWO_SIDED|95.0|-0.42|0.09|||t-test, 2 sided|||||0.09|-0.42|.199
70968392|NCT00492752|141442673|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6783||||0.014144||95.0|0.4962|0.9272|||Log Rank||Hazard ratio is for Sorafenib vs placebo.|||0.9272|0.4962|0.014144
70968393|NCT00492752|141442673|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6208||||0.003464||95.0|0.4498|0.8568|||Log Rank|log rank test stratified by country, tumor burden, and ECOG.|Hazard ratio is for Sorafenib vs placebo|||0.8568|0.4498|0.003464
70968394|NCT00492752|141442674|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9032||||0.497537||95.0|0.6705|1.2165|||Log Rank||Hazard ratio is for Sorafenib vs placebo.|||1.2165|0.6705|0.497537
70968395|NCT00492752|141442674|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8831||||0.437926||95.0|0.6449|1.2093|||Log Rank|log rank test stratified by country, tumor burden, and ECOG.|Hazard ratio is for Sorafenib vs placebo|||1.2093|0.6449|0.437926
70968396|NCT00492752|141442675|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5744||||0.000537||95.0|0.4154|0.7942|||Log Rank||Hazard ratio is for Sorafenib vs placebo|||0.7942|0.4154|0.000537
70968397|NCT00492752|141442675|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5375||||0.00054||95.0|0.3763|0.7677|||Log Rank|log rank test stratified by country, tumor burden, and ECOG.|Hazard ratio is for Sorafenib vs placebo|||0.7677|0.3763|0.000540
70968398|NCT00492752|141442676|SUPERIORITY_OR_OTHER||Disease control rate|0.3533||||||95.0|0.2771|0.4355||||||||0.4355|0.2771|
70968399|NCT00492752|141442676|SUPERIORITY_OR_OTHER||Disease control rate|0.1579||||||95.0|0.0843|0.2596||||||||0.2596|0.0843|
70968400|NCT00492752|141442679|SUPERIORITY_OR_OTHER|||||||0.67|||||||Fisher Exact|based on tumor response rate (CR+PR)||||||0.67
70968401|NCT02258451|141442687|SUPERIORITY||Hazard Ratio (HR)|0.891||||0.4843|TWO_SIDED|80.0|0.72|1.102||1-sided SSE-FS hypotheses were tested using a log-rank test with a 2-sided alpha of 0.2, stratified by the randomization stratification factors.|Log Rank||The hazard ratio (radium-223 dichloride / placebo) for SSE-FS was calculated using Cox Proportional Hazards Model, stratified by the same stratification factors as randomization.|The 1-sided null hypothesis that treatment with radium-223 dichloride does not result in superior SSE-FS to treatment with placebo in participant population was tested against the 1-sided alternative hypothesis that the treatment with radium-223 dichloride results in superior SSE-FS time to treatment the placebo. H0: SSE-FS Radium-223+Exemestane/Everolimus \<= SSE-FS Placebo+Exemestane/Everolimus, versus HA: SSE-FSRadium-223+Exemestane/Everolimus \> SSE-FS Placebo+Exemestane/Everolimus||1.102|0.720|0.4843
70968402|NCT02258451|141442688|SUPERIORITY||Hazard Ratio (HR)|0.968||||0.8438|TWO_SIDED|95.0|0.697|1.343||P-value was calculated using a 2-sided log-rank test stratified by the same stratification factors as randomization. No alpha adjustment for multiplicity was applied.|Log Rank||The hazard ratio (radium-223 dichloride / placebo) was calculated using Cox Proportional Hazards Model , stratified by the same stratification factors as randomization.|||1.343|0.697|0.8438
70968403|NCT02258451|141442689|SUPERIORITY||Hazard Ratio (HR)|0.962||||0.8811|TWO_SIDED|95.0|0.577|1.604||P-value was calculated using a 2-sided log-rank test stratified by the same stratification factors as randomization. No alpha adjustment for multiplicity was applied.|Log Rank||The hazard ratio (radium-223 dichloride / placebo) was calculated using Cox Proportional Hazards Model , stratified by the same stratification factors as randomization.|||1.604|0.577|0.8811
70968404|NCT02258451|141442690|SUPERIORITY||Hazard Ratio (HR)|0.928||||0.6537|TWO_SIDED|95.0|0.667|1.289||P-value was calculated using a 2-sided log-rank test stratified by the same stratification factors as randomization. No alpha adjustment for multiplicity was applied.|Log Rank||The hazard ratio (radium-223 dichloride / placebo) was calculated using Cox Proportional Hazards Model , stratified by the same stratification factors as randomization.|Participants with baseline WPS \> 8 were included in the analysis population but censored at Day 1.||1.289|0.667|0.6537
70968405|NCT02258451|141442691|SUPERIORITY||Hazard Ratio (HR)|0.884||||0.4496|TWO_SIDED|95.0|0.641|1.219||P-value was calculated using a 2-sided log-rank test stratified by the same stratification factors as randomization. No alpha adjustment for multiplicity was applied.|Log Rank||The hazard ratio (radium-223 dichloride / placebo) was calculated using Cox Proportional Hazards Model , stratified by the same stratification factors as randomization.|||1.219|0.641|0.4496
70968406|NCT02258451|141442692|SUPERIORITY||Hazard Ratio (HR)|0.874||||0.3467|TWO_SIDED|95.0|0.66|1.157||P-value was calculated using a 2-sided log-rank test stratified by the same stratification factors as randomization. No alpha adjustment for multiplicity was applied.|Log Rank||The hazard ratio (radium-223 dichloride / placebo) was calculated using Cox Proportional Hazards Model , stratified by the same stratification factors as randomization.|||1.157|0.660|0.3467
70968407|NCT02258451|141442693|SUPERIORITY||Risk Difference (RD)|4.1||||0.556|TWO_SIDED|95.0|-10.2|18.4||P-value was calculated using a 2-sided Cochran-Mantel-Haenszel test stratified by the same stratification factors as randomization. No alpha adjustment for multiplicity was applied.|Cochran-Mantel-Haenszel|||||18.4|-10.2|0.556
70968408|NCT03834519|141442706|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.2616|TWO_SIDED|95.0|0.77|1.14|||Log Rank|One-sided p-value based on log-rank test stratified by measurable disease status and prior NHA treatment.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|Treatment difference in survival assessed by the stratified log-rank test stratified by measurable disease status and prior NHA treatment.||1.14|0.77|0.2616
70968409|NCT03834519|141442707|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.5544|TWO_SIDED|95.0|0.82|1.25|||Log Rank|One-sided p-value based on log-rank test stratified by measurable disease status and prior NHA treatment.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|Treatment difference in rPFS assessed by the stratified log-rank test stratified by measurable disease status and prior NHA treatment.||1.25|0.82|0.5544
70968410|NCT03834519|141442708|OTHER|Treatment difference in TFST|Hazard Ratio (HR)|0.86||||||95.0|0.71|1.03|||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|||1.03|0.71|
70968411|NCT03834519|141442709|OTHER|Treatment difference in ORR|Difference in percentage|10.9|||||TWO_SIDED|95.0|4.0|17.1||||||||17.1|4.0|
70968412|NCT03834519|141442711|OTHER|Treatment difference in time to PSA progression|Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.89|1.38|||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|||1.38|0.89|
70968413|NCT03834519|141442712|OTHER|Treatment difference in SSRE|Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.38|0.78|||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|||0.78|0.38|
70968414|NCT03834519|141442713|OTHER|Treatment difference in time to radiographic soft tissue progression|Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.62|1.0|||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|||1.00|0.62|
70968415|NCT03834519|141442714|OTHER|Treatment difference in TTPE|Hazard Ratio (HR)|0.95||||0.3643|TWO_SIDED|95.0|0.72|1.26|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|||1.26|0.72|0.3643
70968416|NCT02958007|141442761|SUPERIORITY|||||||0.544|||||||t-test, 2 sided|||||||0.544
70968417|NCT01484977|141442762|SUPERIORITY_OR_OTHER||Retention Rate|73.3|||||TWO_SIDED|95.0|65.42|81.25||||||"Analyses of the primary efficacy variable will be descriptive only. No hypothesis tests are planned.~The number and percentage of subjects remaining in the study through the 21-Week Treatment Period will be calculated. Subjects with retention will be counted in the numerator. All subjects in the relevant population will be used as the denominator.~This percentage will be known as the retention rate, along with the 95 % confidence interval based on the normal approximation."||81.25|65.42|
70968418|NCT00495820|141442763|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
70968419|NCT00495820|141442764|SUPERIORITY_OR_OTHER||||||=|0.01|||||||Mixed Models Analysis|||||||=0.01
70968420|NCT03080883|141442801|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.3117|TWO_SIDED|95.0|0.38|1.37|||Gray Test P-value|||||1.37|0.38|0.3117
70968421|NCT03080883|141442802|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.997|TWO_SIDED|95.0|0.4|2.53|||Gray Test P-value|||||2.53|0.40|0.9970
